,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
1,32343035,Comparison of lumbar segmental stabilization and general exercises on clinical and radiologic criteria in grade-I spondylolisthesis patients: A double-blind randomized controlled trial.,"OBJECTIVES


The effects of different physiotherapy protocols on patients suffering from grade-I spondylolisthesis have been thus far examined in a limited number of clinical trials. Therefore, the main purpose of this study was to compare the effects of lumbar segmental stabilization and general exercises on clinical and radiologic criteria in grade-I spondylolisthesis patients.
METHODS


This study was a double-blind randomized controlled trial (RCT) with a test-retest design and parallel groups. A total of 26 patients with grade-I spondylolisthesis were thus randomly assigned to experimental group (13 patients, lumbar segmental stabilization exercises) and control group (13 patients, general exercises). Subsequently, pain, functional disability, kinesiophobia, translational motion, angular motion and slip percentage of the vertebra were investigated.
RESULTS


Of the 120 people recruited in this study, only 26 patients were eligible. According to pre/post-intervention comparison, a statistically significant decrease was observed in the experimental group in terms of pain (p = 0.000), functional disability (p = 0.004), kinesiophobia (p = 0.002), translational motion (p = 0.043) and angular motion (p = 0.011), but not for slip percentage (p = 0.122). Considering the control group, a statistically significant decline was reported for pain (p = 0.043) and functional disability (p = 0.002). However, no significant differences were found for other variables in the control group. With regard to inter-group comparison, there was no statistically significant difference between the two groups regarding the given variables except for kinesiophobia (p = 0.040).
CONCLUSION


Both lumbar segmental stabilization and general exercises led to reduction in pain and functional disability of patients with grade-I spondylolisthesis. Therefore, lumbar segmental stabilization exercises seemed to be better than general ones with reference to improving kinesiophobia and intervertebral movements.",2020,"Considering the control group, a statistically significant decline was reported for pain (p = 0.043) and functional disability (p = 0.002).","['I spondylolisthesis', 'grade', 'patients with grade-I spondylolisthesis', 'grade-I spondylolisthesis patients', '120 people recruited in this study', '26 patients with grade', 'I spondylolisthesis patients', 'patients suffering from grade-I spondylolisthesis', '26 patients were eligible']","['lumbar segmental stabilization exercises) and control group (13 patients, general exercises', 'lumbar segmental stabilization and general exercises', 'lumbar segmental stabilization exercises', 'physiotherapy protocols']","['angular motion', 'pain and functional disability', 'translational motion', 'pain, functional disability, kinesiophobia, translational motion, angular motion and slip percentage of the vertebra', 'kinesiophobia', 'pain', 'functional disability']","[{'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]",26.0,0.0958347,"Considering the control group, a statistically significant decline was reported for pain (p = 0.043) and functional disability (p = 0.002).","[{'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Mohammadimajd', 'Affiliation': 'Department of Physiotherapy, Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Lotfinia', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Salahzadeh', 'Affiliation': 'Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Aghazadeh', 'Affiliation': 'Image Processing Laboratory, Department of Applied Mathematics, Azarbaijan Shahid Madani University, Tabriz, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Noras', 'Affiliation': 'Image Processing Laboratory, Department of Applied Mathematics, Azarbaijan Shahid Madani University, Tabriz, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Poureisa', 'Affiliation': 'Faculty of Paramedical, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'School of Public Health, Department of Statistic and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Choopani', 'Affiliation': 'Department of Physiotherapy, Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1843']
2,32339768,Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events.,"Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link-including empirical support for shared etiological and functional connections between SUP and PTSD -the field has been void of a gold standard treatment for adolescent populations. To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events. The purpose of this paper is to provide a detailed description of the design and methods of this RCT designed to reduce SUP, PTSD symptoms, and related risk behaviors, with outcomes measured from pre-treatment through 18 months post-entry. Specifically, the recruitment and sampling procedures, assessment measures and methods, description of the intervention, and planned statistical approaches to evaluating the full range of outcomes are detailed. Clinical and research implications of this work are also discussed.",2020,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","['adolescents who have experienced IPV and other traumatic events', 'adolescents who have experienced interpersonal violence and other traumatic events']","['integrative treatment', 'Risk Reduction through Family Therapy (RRFT']","['SUP, PTSD symptoms, and related risk behaviors', 'negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0401951,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: danielso@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106012']
3,32340075,Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,"OBJECTIVE


To compare electrodiathermy with helium thermal coagulation in laparoscopic treatment of mild-to-moderate endometriosis.
DESIGN


Parallel-group randomised controlled trial.
SETTING


A UK endometriosis centre.
POPULATION


Non-pregnant women aged 16-50 years with a clinical diagnosis of mild-to-moderate endometriosis.
METHODS


If mild or moderate endometriosis was confirmed at laparoscopy, women were randomised to laparoscopic treatment with electrodiathermy or helium thermal coagulator.
MAIN OUTCOME MEASURES


Cyclical pain and dyspareunia (rated on a 100-mm visual analogue scale, VAS), quality of life at baseline and at 6, 12 and 36 weeks following surgery, operative blood loss and surgical complications.
RESULTS


A total of 192 women were randomised. Of these, 155 (81%) completed the primary outcome point at 12 weeks. In an intention-to-treat analysis, VAS scores for cyclical pain were significantly lower in the electrodiathermy group compared with the helium group at 12 weeks (mean difference, 9.43 mm; 95% CI 0.46, 18.40 mm; P = 0.039) and across all time points (mean difference, 10.13 mm; 95% CI 3.48, 16.78 mm; P = 0.003). A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference, 11.66 mm; 95% CI 1.39, 21.93 mm; P = 0.026). These effects were smaller than the proposed minimum important difference of 18.00 mm, however. Differences in some aspects of quality of life favoured electrodiathermy. There was no significant difference in operative blood loss (fold-change with helium as reference, 1.43; 95% CI 0.96, 2.15; P = 0.081).
CONCLUSIONS


Although electrodiathermy was statistically superior to helium ablation in reducing cyclical pain and dyspareunia, these effects may be too small to be clinically significant.
TWEETABLE ABSTRACT


Helium coagulation is not superior to electrodiathermy in laparoscopic treatment of mild-to-moderate endometriosis.",2020,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","['laparoscopic treatment of mild-to-moderate endometriosis', 'A UK endometriosis centre', '192 women were randomized', 'mild-to-moderate endometriosis', 'Non-pregnant women aged 16-50 with a clinical diagnosis of mild-to-moderate endometriosis']","['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy', 'electrodiathermy', 'laparoscopic treatment with electrodiathermy or helium thermal coagulator']","['cyclical pain and dyspareunia', 'operative blood loss; surgical complications', 'Cyclical pain and dyspareunia (rated on 100mm visual analogue scales), and quality of life', 'dyspareunia', 'operative blood loss', 'VAS scores for cyclical pain']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",192.0,0.391918,"A significant difference in dyspareunia also favoured electrodiathermy at 12 weeks (mean difference = 11.66mm; 95% CI 1.39, 21.93; p = 0.026).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'El-Gizawy', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jerreat', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritchie', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16279']
4,32340910,The impact of heart rate-based drowsiness monitoring on adverse driving events in heavy vehicle drivers under naturalistic conditions.,"OBJECTIVES


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


Prospective, non-randomized trial.
SETTING


Naturalistic driving in Malaysia.
PARTICIPANTS


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


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


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


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


Including drowsiness detection devices in fatigue management programs appears to alter driver behaviour, improving safety despite the modest accuracy. Longer term studies are required to determine if this change is sustained.",2020,"There was a significant decrease in the rate of harsh braking events (Rate ratio = 0.48, p < 0.05) and a fall in subjective sleepiness (p < 0.05) when the device was operated in the active mode (compared to the silent mode).","['heavy vehicle drivers under naturalistic conditions', 'Heavy vehicle drivers in Malaysia', 'Naturalistic driving in Malaysia']","['Control condition', 'heart rate-based drowsiness monitoring', 'wrist-worn heart rate drowsiness detection device']","['rate of driving events', 'subjective sleepiness', 'harsh braking and harsh acceleration driving events and self-reported sleep duration and sleepiness daily', 'rate of harsh braking events']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337108', 'cui_str': 'Brake'}]",,0.0251325,"There was a significant decrease in the rate of harsh braking events (Rate ratio = 0.48, p < 0.05) and a fall in subjective sleepiness (p < 0.05) when the device was operated in the active mode (compared to the silent mode).","[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Wolkow', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, 145 Studley Road, PO Box 5555, Heidelberg, VIC, Australia.'}, {'ForeName': 'Dexter', 'Initials': 'D', 'LastName': 'Shee', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Lillington', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Roest', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Marx', 'Affiliation': 'Shell International, Carel van Bylandtlaan 16, The Hague, the Netherlands.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Chew', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tucker', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia.'}, {'ForeName': 'Shamsul', 'Initials': 'S', 'LastName': 'Haque', 'Affiliation': 'Jeffrey Cheah School of Medicine and Health Sciences, Department of Psychology, Monash University Malaysia, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schaefer', 'Affiliation': 'Neurobusiness Behavioural Laboratory, Monash University Malaysia, Building 6B, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, 18 Innovation Walk, Clayton, VIC, Australia; Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, 145 Studley Road, PO Box 5555, Heidelberg, VIC, Australia. Electronic address: mark.howard@austin.org.au.'}]",Sleep health,['10.1016/j.sleh.2020.03.005']
5,32359142,Dose-response effects of dietary protein on muscle protein synthesis during recovery from endurance exercise in young men: a double-blind randomized trial.,"BACKGROUND


Protein ingestion increases skeletal muscle protein synthesis rates during recovery from endurance exercise.
OBJECTIVES


We aimed to determine the effect of graded doses of dietary protein co-ingested with carbohydrate on whole-body protein metabolism, and skeletal muscle myofibrillar (MyoPS) and mitochondrial (MitoPS) protein synthesis rates during recovery from endurance exercise.
METHODS


In a randomized, double-blind, parallel-group design, 48 healthy, young, endurance-trained men (mean ± SEM age: 27 ± 1 y) received a primed continuous infusion of l-[ring-2H5]-phenylalanine, l-[ring-3,5-2H2]-tyrosine, and l-[1-13C]-leucine and ingested 45 g carbohydrate with either 0 (0 g PRO), 15 (15 g PRO), 30 (30 g PRO), or 45 (45 g PRO) g intrinsically l-[1-13C]-phenylalanine and l-[1-13C]-leucine labeled milk protein after endurance exercise. Blood and muscle biopsy samples were collected over 360 min of postexercise recovery to assess whole-body protein metabolism and both MyoPS and MitoPS rates.
RESULTS


Protein intake resulted in ∼70%-74% of the ingested protein-derived phenylalanine appearing in the circulation. Whole-body net protein balance increased dose-dependently after ingestion of 0, 15, 30, or 45 g protein (mean ± SEM: -0.31± 0.16, 5.08 ± 0.21, 10.04 ± 0.30, and 13.49 ± 0.55 μmol phenylalanine · kg-1 · h-1, respectively; P < 0.001). 30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise. MitoPS rates were not increased after protein ingestion; however, incorporation of dietary protein-derived l-[1-13C]-phenylalanine into de novo mitochondrial protein increased dose-dependently after ingestion of 15, 30, and 45 g protein at 360 min postexercise (0.018 ± 0.002, 0.034 ± 0.002, and 0.046 ± 0.003 mole percentage excess, respectively; P < 0.001).
CONCLUSIONS


Protein ingested after endurance exercise is efficiently digested and absorbed into the circulation. Whole-body net protein balance and dietary protein-derived amino acid incorporation into mitochondrial protein respond to increasing protein intake in a dose-dependent manner. Ingestion of 30 g protein is sufficient to maximize MyoPS rates during recovery from a single bout of endurance exercise.This trial was registered at trialregister.nl as NTR5111.",2020,30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise.,"['48 healthy, young, endurance-trained men (mean\xa0±\xa0SEM age: 27\xa0±\xa01 y) received a', 'young men']","['l-[1-13C]-phenylalanine and l-[1-13C]-leucine labeled milk protein after endurance exercise', 'dietary protein co-ingested with carbohydrate', 'dietary protein', 'Protein ingestion', 'primed continuous infusion of l-[ring-2H5]-phenylalanine, l-[ring-3,5-2H2]-tyrosine, and l-[1-13C]-leucine and ingested 45 g carbohydrate with either 0 (0 g PRO', 'endurance exercise']","['incorporation of dietary protein-derived l-[1-13C]-phenylalanine into de novo mitochondrial protein', 'muscle protein synthesis', 'whole-body protein metabolism, and skeletal muscle myofibrillar (MyoPS) and mitochondrial (MitoPS) protein synthesis rates', 'MyoPS rates', 'Blood and muscle biopsy samples', 'MitoPS rates']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",,0.0582953,30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise.,"[{'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Churchward-Venne', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Philippe J M', 'Initials': 'PJM', 'LastName': 'Pinckaers', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joey S J', 'Initials': 'JSJ', 'LastName': 'Smeets', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Milan W', 'Initials': 'MW', 'LastName': 'Betz', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Senden', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joy P B', 'Initials': 'JPB', 'LastName': 'Goessens', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Annemie P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Rollo', 'Affiliation': 'Gatorade Sports Science Institute, Leicester, United Kingdom.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa073']
6,32345747,Kidney Functional Magnetic Resonance Imaging and Change in eGFR in Individuals with CKD.,"BACKGROUND AND OBJECTIVES


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


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


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


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


CKD Optimal Management with Binders and Nicotinamide (COMBINE), NCT02258074.",2020,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.08).","['Individuals with CKD', '122 participants of the CKD Optimal Management with Binders and Nicotinamide trial', 'conducted in individuals with eGFR 20-45 ml/min per 1.73 m 2 ', '87 participants with 12-month follow-up MRI data', 'patients at high risk of CKD progression']",['nicotinamide and lanthanum carbonate versus placebo'],"['relaxation rate', 'kidney functional MRI biomarkers change over time', 'blood oxygen level', 'baseline kidney functional MRI biomarkers', 'mean annual eGFR slope', 'Kidney functional MRI biomarkers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",87.0,0.570967,"This association was no longer significant after further adjustment for albuminuria (difference in annual eGFR slope per 1 SD increase in ADC: 1.0 (95% CI, -0.1 to 2.2) ml/min per 1.73 m 2  per year, ADC×time interaction  P =0.08).","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois anand.srivastava@northwestern.edu.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Jungwha', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kendrick', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Michel B', 'Initials': 'MB', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Division of Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Dallas, Texas.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, Renal Section, University of San Diego, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Pottumarthi V', 'Initials': 'PV', 'LastName': 'Prasad', 'Affiliation': 'Department of Radiology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Division of Nephrology and Hypertension, Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13201019']
7,32360042,Survival probability of zirconia-reinforced lithium silicate ceramic: Effect of surface condition and fatigue test load profile.,"OBJECTIVES


The present investigation evaluated the step stress accelerated test (SSALT) load profiles on the survival probability of a glass ceramic under two surface conditions (polished or roughened).
METHODS


Suprinity-ZLS blocks (Vita Zhanfabrik) were shaped into cylinders, cut in a sawing machine, and crystalized according to the manufacturer's instructions. 60 discs were obtained (Ø=12mm, thickness=1.2mm) and randomly assigned into two surface conditions: ""p"" polished surface (400-1200-grit SiC papers), and ""r"" roughened surface (200-grit SiC papers). Profilometry was performed in all discs to evaluate average surface roughness prior to flexural fatigue strength testing. 3 discs of each group were submitted to biaxial flexural strength in an universal testing machine (0.5mm/min) and the mean load to failure (N) was calculated to determine SSALT profiles. 27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9), and submitted to the fatigue test (60-320N, 140,000 cycles at 1.4Hz). The results were analyzed using the Kaplan-Meier and Wilcoxon tests (5%), 2-way ANOVA and Tukey test (α=5%).
RESULTS


Kaplan-Meier and generalized Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05). A rough internal surface impacted deleteriously on the fatigue strength and reliability of ZLS ceramic. Both surface conditions were more sensitive to the aggressive profile than the other profiles, even worst for the roughened group. Regardless the load profile, 0% survival probability was observed at 384MPa for polished condition. While for roughened, aggressive tested specimens did not survived 147MPa followed by moderate at 312MPa and mild at 384MPa. The failure modes showed fracture marks originating from superficial grooves for both surface conditions.
SIGNIFICANCE


Polished specimens are sensitive to the load profile variation, confirming the effect of surface morphology on the fatigue results.",2020,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"['Suprinity-ZLS blocks (Vita Zhanfabrik', '27 specimens per surface condition were assigned into three profiles - Mild (n=9), Moderate (n=9), and Aggressive (n=9']","['Wilcoxon', 'zirconia-reinforced lithium silicate ceramic']","['fatigue strength and reliability of ZLS ceramic', 'Survival probability', 'Kaplan-Meier and Wilcoxon tests', 'survival probability', 'biaxial flexural strength']","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0086983', 'cui_str': 'Silicate salt'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",60.0,0.0177578,Wilcoxon showed (P=0.002) that polished groups showed higher survival probability than roughened condition (P<0.05).,"[{'ForeName': 'Amanda Maria de Oliveira', 'Initials': 'AMO', 'LastName': 'Dal Piva', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: amodalpiva@gmail.com.'}, {'ForeName': 'João Paulo Mendes', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil; Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: joao.tribst@unesp.br.'}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'PhD Graduate Program in Oral Science (Prosthodontics Unit), Faculty of Odontology, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Lilian Costa', 'Initials': 'LC', 'LastName': 'Anami', 'Affiliation': 'Department of Prosthodontics, Santo Amaro University, São Paulo, Brazil. Electronic address: lianami@gmail.com.'}, {'ForeName': 'Estevam Augusto', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, University of São Paulo, Bauru School of Dentistry, Brazil. Electronic address: estevamab@gmail.com.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'PhD Graduate Program in Restorative Dentistry, São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, SP, Brazil. Electronic address: mmbottino@uol.com.br.'}, {'ForeName': 'Cornelis Johannes', 'Initials': 'CJ', 'LastName': 'Kleverlaan', 'Affiliation': 'Department of Dental Materials Science, Academic Centre for Dentistry Amsterdam (ACTA), Universiteit van Amsterdam and Vrije Universiteit, The Netherlands. Electronic address: c.kleverlaan@acta.nl.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.03.029']
8,32360852,Clinical and immunological peri-implant parameters among cigarette and electronic smoking patients treated with photochemotherapy: A randomized controlled clinical trial.,"BACKGROUND


Although studies have been done that evaluated the effect of photodynamic therapy (PDT) in cigarette smokers and vapers, however, literature on the impact of these types of smoking on peri-implant parameters lack. The present clinical trial assessed the effectiveness of PDT as an adjunctive therapeutic modality in the treatment of peri-implant mucositis (p-iM) in individuals vaping e-cigs and cigarette smokers.
METHODS


Individuals with p-iM were divided into three groups. (a) Group 1: Cigarette smokers with p-iM (b) Group 2: Vapers (e-cigarette smokers) with p-iM, (c) Group 3: Non-smokers with p-iM. Plaque index (PI), bleeding on probing (BOP) and probing depth (PD) were calculated. Pro-inflammatory biomarkers including matrix metalloproteinase (MMP)-8 and tumor necrosis factor-alpha (TNF-α) were quantified using enzyme linked immunosorbent assay. All assessments were performed at baseline (before treatment) and 12 weeks post treatment. Full mouth disinfection (FMD) was done with the ultrasonic scaler and copious irrigation. The photodynamic therapy (PDT) was done with a diode laser (wavelength: 670 nm, power: 150 mW, density: 1.1 W/cm2). Methylene blue photosensitizer (0.005% concentration) was incorporated inside the periimplant pockets (10 seconds at a depth of 3 mm), and the pockets were irradiated a flexible tip for one minute on the buccal and lingual surfaces. The session of PDT was performed only once at baseline.
RESULTS


Twenty-five cigarette-smokers (Group 1), 21 electronic cigarette smokers (Group 2) and 25 never-smokers (Group 3) participated in the study. The mean age of the selected participants in groups 1, 2 and 3 was 29.5, 27.8, and 30.2 years, respectively. Statistically significant reduction in PI and PD parameters was observed on baseline and at 12 weeks in all groups. BOP significantly increased in group 1 and 2 at 12 weeks. A statistically significant reduction from baseline to 12 weeks was reported in the biomarker levels for all the study groups.
CONCLUSION


PDT with adjunctive mechanical debridement reduced the plaque index and probing depth, while increased bleeding on probing, in addition to reducing pro-inflammatory biomarkers in tobacco smokers.",2020,Pro-inflammatory biomarkers including matrix metalloproteinase (MMP)-8 and tumor necrosis factor-alpha (TNF-α) were quantified using enzyme linked immunosorbent assay.,"['Twenty-five cigarette-smokers (Group 1', 'individuals vaping e-cigs and cigarette smokers', 'cigarette and electronic smoking patients treated with', '21 electronic cigarette smokers (Group 2) and 25 never-smokers (Group 3) participated in the study', 'Individuals with p-iM']","['photodynamic therapy (PDT', 'photochemotherapy', 'Full mouth disinfection (FMD', 'Methylene blue photosensitizer', 'PDT', 'ultrasonic scaler and copious irrigation']","['plaque index and probing depth', 'peri-implant mucositis', 'BOP', 'biomarker levels', 'matrix metalloproteinase (MMP)-8 and tumor necrosis factor-alpha (TNF-α', 'PI and PD parameters', 'Plaque index (PI), bleeding on probing (BOP) and probing depth (PD']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0183103', 'cui_str': 'Dental ultrasonic scaler'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",21.0,0.0181344,Pro-inflammatory biomarkers including matrix metalloproteinase (MMP)-8 and tumor necrosis factor-alpha (TNF-α) were quantified using enzyme linked immunosorbent assay.,"[{'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'Al Deeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alresayes', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'A Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Aasem M', 'Initials': 'AM', 'LastName': 'Alhenaki', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'AlHelal', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Syed Saad', 'Initials': 'SS', 'LastName': 'Shafqat', 'Affiliation': 'Associate Dentist, Medilink Consultant Clinics, Karachi, Pakistan.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia. Electronic address: tajabbar@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101800']
9,32351642,Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children.,"Objectives


Socially-assistive robots (SAR) have been used to reduce pain and distress in children in medical settings. Patients who perceive empathic treatment have increased satisfaction and improved outcomes. We sought to determine if an empathic SAR could be developed and used to decrease pain and fear associated with peripheral IV placement in children.
Methods


We conducted a pilot study of children receiving IV placement. Participating children were randomized to interact with (1) no robot, or a commercially available 3D printed humanoid SAR robot programmed with (2) empathy or (3) distraction conditions. Children and parents completed demographic surveys, and children used an adapted validated questionnaire to rate the robot's empathy on an 8-point Likert scale. Survey scores were compared by the  t -test or chi-square test. Pain and fear were measured by self-report using the FACES and FEAR scales, and video tapes were coded using the CHEOPS and FLACC. Scores were compared using repeated measures 2-way ANOVA. This trial is registered with NCT02840942.
Results


Thirty-one children with an average age of 9.6 years completed the study. For all measures, mean pain and fear scores were lowest in the empathy group immediately before and after IV placement. Children were more likely to attribute characteristics of empathy to the empathic condition (Likert score 7.24  v . 4.70;  p =0.012) and to report that having the empathic vs. distraction robot made the IV hurt less (7.45 vs. 4.88;  p =0.026).
Conclusions


Children were able to identify SAR designed to display empathic characteristics and reported it helped with IV insertion pain and fear. Mean scores of self-reported or objective pain and fear scales were the lowest in the empathy group and the highest in the distraction condition before and after IV insertion. This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.",2020,This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.,"['children in medical settings', 'children', 'children receiving IV placement', 'Thirty-one children with an average age of 9.6 years completed the study', 'Children', 'Participating children']","['interact with (1) no robot, or a commercially available 3D printed humanoid SAR robot programmed with (2) empathy or (3) distraction conditions', 'Socially-assistive robots (SAR']","['pain and fear', 'Pain and fear', 'Mean scores of self-reported or objective pain and fear scales', 'pain and distress', 'FACES and FEAR scales, and video tapes', 'Pain and Distress', 'mean pain and fear scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",31.0,0.0401498,This result suggests empathy improves SAR functionality when used for painful medical procedures and informs future research into SAR for pain management.,"[{'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Trost', 'Affiliation': 'Keck School of Medicine, University of Southern California, Department of Pediatrics, Los Angeles, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chrysilla', 'Affiliation': 'The Boeing Company, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Gold', 'Affiliation': 'Keck School of Medicine, University of Southern California, Department of Pediatrics, Los Angeles, CA, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Matarić', 'Affiliation': 'University of Southern California, Viterbi School of Engineering, Los Angeles, CA, USA.'}]",Pain research & management,['10.1155/2020/7935215']
10,32361977,"Safety, Tolerability and Pharmacokinetics of Vidofludimus calcium (IMU-838) After Single and Multiple Ascending Oral Doses in Healthy Male Subjects.","BACKGROUND AND OBJECTIVE


Vidofludimus is a potent and selective inhibitor of human mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). The clinical efficacy and safety profile of vidofludimus has been analyzed in patients suffering from rheumatoid arthritis and Crohn's disease and ulcerative colitis. In previous sudies, hematuria at higher doses occurred in close temporal relationship to vidofludimus administration and appeared to be dose related. The present report describes the results from two phase 1 studies conducted in healthy male subjects to investigate the safety, tolerability and pharmacokinetics after single and multiple ascending (SAD and MAD) oral doses of IMU-838 (vidofludimus calcium, tablets containing a specific polymorph). The effect of food on the pharmacokinetics of IMU-838 was also assessed in the SAD study.
METHODS


In the SAD study, 12 subjects received single doses of IMU-838 under fasting (10-40 mg) or fed (10 mg) condition in an open-label, partial parallel group design. In the MAD study, 52 subjects received multiple doses of IMU-838 (30-50 mg) in a double-blind, placebo-controlled, parallel group design.
RESULTS


IMU-838 showed dose-proportional pharmacokinetics after single and multiple oral dosing in both SAD and MAD studies. IMU-838 was well absorbed after single daily doses. Food did not impact the pharmacokinetics of IMU-838. The accumulation factor for multiple daily dosing was approximately 2. Steady-state concentrations were reached within about 6-8 days for 30-50 mg groups. The geometric mean plasma half-life of IMU-838 at steady state was approximately 30 h, which supports its use for once-daily dosing regimen. Single and multiple oral doses of IMU-838 were safe and well tolerated.
CONCLUSION


Overall, oral IMU-838 was generally well tolerated in SAD and MAD studies in healthy subjects over a wide dose range of 10-50 mg. IMU-838 was well absorbed after single daily doses. IMU-838 showed dose proportional pharmacokinetics after single and multiple oral dosing.",2020,Food did not impact the pharmacokinetics of IMU-838.,"['healthy subjects', 'healthy male subjects', ""patients suffering from rheumatoid arthritis and Crohn's disease and ulcerative colitis"", 'Healthy Male Subjects']","['IMU-838 under fasting (10-40\xa0mg) or fed (10\xa0mg) condition in an open-label, partial parallel group design', 'IMU-838 (vidofludimus calcium, tablets containing a specific polymorph', 'IMU-838', 'vidofludimus', 'Vidofludimus calcium (IMU-838', 'placebo']","['safe and well tolerated', 'Steady-state concentrations', 'safety, tolerability and pharmacokinetics', 'Safety, Tolerability and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0270602', 'cui_str': 'Latah'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C2974101', 'cui_str': 'vidofludimus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",52.0,0.0440893,Food did not impact the pharmacokinetics of IMU-838.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Muehler', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany. andreas.muehler@imux.com.'}, {'ForeName': 'Hella', 'Initials': 'H', 'LastName': 'Kohlhof', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Groeppel', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vitt', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00623-7']
11,32355959,Corticospinal-motor neuronal plasticity promotes exercise-mediated recovery in humans with spinal cord injury.,"Rehabilitative exercise in humans with spinal cord injury aims to engage residual neural networks to improve functional recovery. We hypothesized that exercise combined with non-invasive stimulation targeting spinal synapses further promotes functional recovery. Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury were randomly assigned to 10 sessions of exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS. In an additional experiment, we tested the effect of PCMS without exercise in 13 individuals with spinal cord injury with similar characteristics. During PCMS, 180 pairs of stimuli were timed to have corticospinal volleys evoked by transcranial magnetic stimulation over the primary motor cortex arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles (depending on the injury level), 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of a peripheral nerve. Participants exercised for 45 min after all protocols. We found that the time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test decreased on average by 20% after all protocols. However, the amplitude of corticospinal responses elicited by transcranial magnetic stimulation and the magnitude of maximal voluntary contractions in targeted muscles increased on overage by 40-50% after PCMS combined or not with exercise but not after sham-PCMS combined with exercise. Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains. Our findings indicate that targeted non-invasive stimulation of spinal synapses might represent an effective strategy to facilitate exercise-mediated recovery in humans with different degrees of paralysis and levels of spinal cord injury.",2020,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","['humans with spinal cord injury', '13 individuals with spinal cord injury with similar characteristics', 'Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury']","['PCMS without exercise', 'exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS', 'Corticospinal-motor neuronal plasticity promotes exercise', 'Rehabilitative exercise', 'exercise combined with sham-PCMS']","['time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test', 'behavioural and physiological effects']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0457848', 'cui_str': 'Segment of lumbar spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.223458,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","[{'ForeName': 'Hang Jin', 'Initials': 'HJ', 'LastName': 'Jo', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Perez', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa052']
12,32356413,Twelve-hour fasting compared with expedited oral intake in the initial inpatient management of hyperemesis gravidarum: a randomised trial.,"OBJECTIVE


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


Randomised trial.
SETTING


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


One hundred and sixty women hospitalised for HG.
METHOD


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


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


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


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


Women hospitalised for hyperemesis gravidarum could feed as soon, as much and as often as can be tolerated compared with initial fasting.",2020,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","['hospitalised hyperemesis gravidarum (HG) DESIGN', '160 women hospitalised for hyperemesis gravidarum (HG) METHOD', 'University Hospital, Malaysia: April 2016-April']",[],"['24-hour vomiting episodes', 'nausea scores', 'satisfaction score', '24-hour nausea scores and vomiting episodes', 'satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score', 'Symptoms profile, ketonuria status at 24 hours and length of hospital stay']","[{'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.218001,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Abdussyukur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16290']
13,32356559,Physical activity and markers of glycation in older individuals: data from a combined cross-sectional and randomized controlled trial (EXAMIN AGE).,"BACKGROUND


Advanced glycation end products (AGEs) are protein modifications that are predominantly formed from dicarbonyl compounds that arise from glucose and lipid metabolism. AGEs and sedentary behavior have been identified as a driver of accelerated (vascular) aging. The effect of physical activity on AGE accumulation is unknown. Therefore, we investigated whether plasma AGEs and dicarbonyl levels are different across older individuals that were active or sedentary and whether plasma AGEs are affected by high-intensity interval training (HIIT).
METHODS


We included healthy older active (HA, n=38, 44.7% female, 60.1 ± 7.7 years old) and healthy older sedentary (HS, n=36, 72.2% female, 60.0 ± 7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR, n=84, 50% female, 58.7 ± 6.6 years old). The SR group was randomized into a 12-week walking-based HIIT program or control group. We measured protein-bound and free plasma AGEs and dicarbonyls by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) at baseline and after the HIIT intervention.
RESULTS


Protein-bound AGE Nε-(carboxymethyl)lysine (CML) was lower in SR (2.6 ± 0.5 μmol/l) and HS (3.1 ± 0.5 μmol/l) than in HA (3.6 ± 0.6 μmol/l; P<0.05) and remained significantly lower after adjustment for several potential confounders. None of the other glycation markers were different between HS and HA. HIIT did not change plasma AGEs and dicarbonyls in SR.
DISCUSSION


Although lifestyle interventions may act as important modulators of cardiovascular risk, HIIT is not a potent short-term intervention to reduce glycation in older individuals, underlining the need for other approaches, such as pharmacological agents, to reduce AGEs and lower cardiovascular risk in this population.",2020,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","['older individuals that were active or sedentary and whether plasma AGEs are affected by high intensity interval training (HIIT', 'older individuals', 'healthy older active (HA,\xa0n=38, 44.7% female, 60.1±7.7 years old) and healthy older sedentary (HS,\xa0n=36, 72.2% female, 60.0±7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR,\xa0n=84, 50% female, 58.7±6.6 years old']",['walking-based HIIT program or control group'],"['plasma AGEs and dicarbonyl levels', 'Physical activity and markers of glycation', 'protein-bound and free plasma AGEs and dicarbonyls by UPLC-MS/MS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033618', 'cui_str': 'Protein binding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]",,0.0486955,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","[{'ForeName': 'Mathias D G', 'Initials': 'MDG', 'LastName': 'Van den Eynde', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Streese', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alfons J H M', 'Initials': 'AJHM', 'LastName': 'Houben', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Coen D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jean L J M', 'Initials': 'JLJM', 'LastName': 'Scheijen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Casper G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Nordin M J', 'Initials': 'NMJ', 'LastName': 'Hanssen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}]","Clinical science (London, England : 1979)",['10.1042/CS20200255']
14,32305659,The impact of state and dispositional mindfulness on prospective memory: A virtual reality study.,"Prospective memory (PM) consists of remembering to perform an action that was previously planned. The recovery and execution of these actions require attentional resources. Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures. In this study, we investigated the impact of mindfulness on PM. Eighty participants learned 15 cue-action associations. They were, then, asked to recall the actions at certain moments (time-based items) or places (event-based items) during a walk in a virtual town. Before the PM task, participants were randomly assigned to a mindfulness or mind wandering (control condition) session. Dispositional mindfulness was measured via the Five Facets Mindfulness Questionnaire (FFMQ). Although considered as two opposite states, we did not report any difference between the two groups on PM abilities. Nevertheless, the natural tendency to describe one's own sensations (the Describing facet of the FFMQ) predicted time-based performance in both groups. We discuss different hypotheses to explain this finding in light of recent findings on the impact of mind wandering on future oriented cognition. Our main observation is a positive link between the Describing facet and time-based PM performances. We propose that this link could be due to the common association of this mindfulness facets and PM with attentional and interoceptive abilities. Additional studies are needed to explore this hypothesis.",2020,"Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures.",['Eighty participants learned 15 cue-action associations'],['mindfulness or mind wandering (control condition) session'],"['Dispositional mindfulness', 'Five Facets Mindfulness Questionnaire (FFMQ', 'PM abilities']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",80.0,0.0266846,"Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures.","[{'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Girardeau', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France. Electronic address: jean-charles.girardeau@parisdescartes.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Blondé', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Makowski', 'Affiliation': 'School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Abram', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Piolino', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France; Institut Universitaire de France (IUF), France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sperduti', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102920']
15,32374123,"The relation between the storage symptoms before and after transurethral resection of the prostate, analysis of the risk factors and the prevention of the symptoms with solifenacin.","OBJECTIVE AND HYPOTHESIS


We aimed to investigate the reasons of storage symptoms ( SS) after transurethral resection of the prostate (TURP). The hypothesis was that a positive correlation would be identified between preoperative and postoperative SS in patients with undergoing TURP and starting early solifenacin treatment in patients with high preoperative SS would be reasonable. In addition, we aimed to analyze multiple other risk factors for post-TURP SS.
MATERIALS AND METHODS


A total of 160 patients undergoing TURP were prospectively evaluated and divided into two groups according to their OABS. Those with a score of ≥10 points were Group 1 (G1), and those with < 10 points Group 2 (G2). In addition, patients in each group were randomly further divided into two subgroups: those who were started on 5 mg solifenacin succinate in the early postoperative period (G1/G2 A) and those who were not (G1/G2 B). In additions to SS Preop, perop and at the 3rd-month of postoperatively 14 variable were evaluated. The effects of these factors, surgery and the efficacy of an early medical treatment on the postoperative SS were investigated. LUTS were assessed by International Prostate Symptom Score (IPSS) and SS were assessed by sum of IPSS 2, 4 and 7 questionnaires (Storage, S- IPSS).
RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery. Only preoperative S-IPSS was found to have significant effect on postoperative SS (p< 0.001). There was a significant difference between G1A and G1B but no significant difference between G2A and G2B in terms of SS at postoperatively. In addition to this, prostatic volume was found smaller than non-symptomatic patients in de novo SS patients.
CONCLUSION


TURP provides significant improvement in both storage and voiding symptoms. The predictive value of the preoperative S-IPSS on postop SS is significant. These results suggest that 5 mg solifenacin succinate treatment in the early postoperative period may be beneficial for patients with high preoperative SS and may not be beneficial in others. Small prostatic volume may bode ill for postoperative SS in the patients with de novo SS.",2020,"RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","['patients with high preoperative SS', 'patients with de novo SS', '160 patients undergoing TURP']","['solifenacin succinate', 'TURP', 'transurethral resection of the prostate (TURP']","['prostatic volume', 'postoperative SS', 'G1A and G1B', 'storage and voiding symptoms', 'International Prostate Symptom Score (IPSS) and SS', 'Preoperative IPSS and S-IPSS', 'IPSS, S-IPSS, QoL score, Qmax, and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C1509436', 'cui_str': 'Solifenacin succinate'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",160.0,0.0169544,"RESULTS


Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","[{'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Sipal', 'Affiliation': 'Depertment of Urology, Cerkezkoy State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Akdere', 'Affiliation': 'Depertmen of Urology, Trakya University Medical Faculty, Edirne, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0227']
16,32374130,Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty in children: pre-liminary results of a pilot prospective ran-domized controlled trial.,,2020,,['children'],['Editorial Comment: Laparoscopy versus robotic-assisted pyeloplasty'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}]",[],,0.0347665,,"[{'ForeName': 'Eliney F', 'Initials': 'EF', 'LastName': 'Faria', 'Affiliation': 'Serviço de Urologia, Hospital Felicio Rocho, Belo Horizonte, MG, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.04.05']
17,32344403,"Effect of Unilateral Left Nostril Breathing (Chandra Anga Pranayama) on Cognitive Function in Healthy Yoga-Naïve Individuals: A Randomized, Controlled, Pilot Study.","INTRODUCTION


Breathing modulates cortical neuronal activity. Various breathing exercises are purported to have specific effects on emotional and cognitive functions.
OBJECTIVE


To determine the effect of unilateral left nostril breathing (ULNB) on nonlateralized, overall cognitive functions using computerized psychometric tests.
METHODS


A randomized, controlled, pilot study was conducted among 20 healthy yoga-naïve medical students. ULNB was performed for 15 min by the test group (n = 10) and breath awareness by the control group (n = 10). Attention and processing speed, memory, and executive function were assessed using the Letter-Digit Substitution Test, Sternberg Memory Task, and Victoria Stroop Test, respectively. Baseline, pre- and postintervention scores were recorded.
RESULTS


There was no significant difference between the groups in baseline scores. In the Sternberg Memory Task, a statistically significant decrease in response time was seen in the test (t(9) = 3.855, p = 0.004) as well as the control group (t(9) = 3.120, p = 0.012); there was no significant difference between the groups. No significant effect of UNLB was seen in the Letter-Digit Substitution Test and Stroop Test.
CONCLUSIONS


Our study showed no difference in the effects of 15-min practice of ULNB and breath awareness on cognitive functions; both improved memory but not attention or executive function.",2020,"No significant effect of UNLB was seen in the Letter-Digit Substitution Test and Stroop Test.
","['Healthy Yoga-Naïve Individuals', '20 healthy yoga-naïve medical students']","['Various breathing exercises', 'ULNB', 'unilateral left nostril breathing (ULNB', 'Unilateral Left Nostril Breathing (Chandra Anga Pranayama']","['response time', 'Attention and processing speed, memory, and executive function', 'breath awareness', 'UNLB', 'Letter-Digit Substitution Test and Stroop Test', 'Cognitive Function', 'Letter-Digit Substitution Test, Sternberg Memory Task, and Victoria Stroop Test']","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]",20.0,0.022872,"No significant effect of UNLB was seen in the Letter-Digit Substitution Test and Stroop Test.
","[{'ForeName': 'Sai Suvethasri', 'Initials': 'SS', 'LastName': 'Santhanam Kumar', 'Affiliation': 'Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Kamath', 'Affiliation': 'Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India, ashwin.kamath@manipal.edu.'}, {'ForeName': 'Surekha', 'Initials': 'S', 'LastName': 'Poojary', 'Affiliation': 'Yoga therapist, Mangalore, India.'}]",Complementary medicine research,['10.1159/000506972']
18,32297776,Coaching for primary care physician well-being: A randomized trial and follow-up analysis.,"Primary Care Physicians (PCPs) are integral to the health of all people in the U.S. Many PCPs experience burnout, and declines in well-being. We conducted a randomized controlled trial of a six-session positive psychology-based coaching intervention to improve PCP personal and work-related well-being and decrease stress and burnout. Fifty-nine U.S.-based PCPs were randomized into a primary ( n  = 29) or a waitlisted control group ( n  = 30). Outcome measures were assessed preintervention, postintervention, and at three and six months post-intervention. Hypotheses 1a-1h were for a randomized controlled trial test of coaching on PCP burnout (a), stress (b), turnover intentions (c), work engagement (d), psychological capital (e), compassion (f), job self-efficacy (g), and job satisfaction (h). Results from 50 PCPs who completed coaching and follow-up assessments indicated significantly decreased burnout (H1a) and increased work engagement (H1d), psychological capital (H1e), and job satisfaction (H1h) for the primary group from pre- to postcoaching, compared to changes between comparable time points for the waitlisted group. Hypotheses 2a-2h were for stability of positive effects and were tested using follow-up data from participants in the primary and waitlisted groups combined. Results from 39 PCPs who completed the intervention and the six-month follow-up indicated that positive changes observed for H1a, H1d, H1e, and H1h were sustained during a six-month follow-up (supporting H2a, H2d, H2e, and H2h). Results indicate that coaching is a viable and effective intervention for PCPs in alleviating burnout and improving well-being. We recommend that employers implement coaching for PCPs alongside systemic changes to work factors driving PCP burnout. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Results indicate that coaching is a viable and effective intervention for PCPs in alleviating burnout and improving well-being.,"['primary care physician well-being', 'Fifty-nine U.S.-based PCPs']",['six-session positive psychology-based coaching intervention'],"['burnout (H1a) and increased work engagement (H1d), psychological capital (H1e), and job satisfaction (H1h', 'PCP burnout (a), stress (b), turnover intentions (c), work engagement (d), psychological capital (e), compassion (f), job self-efficacy (g), and job satisfaction (h', 'PCP personal and work-related well-being and decrease stress and burnout']","[{'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0601355,Results indicate that coaching is a viable and effective intervention for PCPs in alleviating burnout and improving well-being.,"[{'ForeName': 'Alyssa K', 'Initials': 'AK', 'LastName': 'McGonagle', 'Affiliation': 'Department of Psychological Science, University of North Carolina at Charlotte.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Schwab', 'Affiliation': 'Atrius Health.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Yahanda', 'Affiliation': 'Department of Organizational and Leadership Psychology, William James College.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Duskey', 'Affiliation': 'Better Therapeutics, LLC.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Gertz', 'Affiliation': 'Nancy Gertz Coaching & Consulting.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Prior', 'Affiliation': 'Prior Consulting, LLC.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Roy Associates.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Kriegel', 'Affiliation': 'Beth Israel Deaconess Medical Center.'}]",Journal of occupational health psychology,['10.1037/ocp0000180']
19,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


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


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


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


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
20,32362221,Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for  Helicobacter pylori  infection.,"AIM


To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for  Helicobacter pylori  infection.
METHODS


This study was a multicenter, randomized-controlled, non-inferiority trial. Subjects endoscopically diagnosed with  H. pylori  infection were randomly allocated to receive modified quadruple- (rabeprazole 20 mg bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT) for 14 days. Rates of eradication success and adverse events were investigated. Antibiotic resistance was determined using the agar dilution and DNA sequencing of the clarithromycin resistance point mutations in the 23 S rRNA gene of  H. pylori .
RESULTS


In total, 233 participants were randomized, 27 were lost to follow-up, and four violated the protocol. Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%,  P  = .37), modified intention-to-treat (96.2% vs. 96%,  P  > .99), and per-protocol (96.2% vs. 96.9%,  P  > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed. The amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates were 8.3, 40, 9.4, 23.5, and 42.2%, respectively. Antimicrobial resistance did not significantly affect the efficacy of either therapy. Overall compliance was 98.1%. Adverse events were not significantly different between the two therapies.
CONCLUSION


Modified quadruple therapy comprising rabeprazole, amoxicillin, metronidazole, and bismuth is an effective first-line treatment for the  H. pylori  infection in regions with high clarithromycin and metronidazole resistance.",2020,"Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%,  P  = .37), modified intention-to-treat (96.2% vs. 96%,  P  > .99), and per-protocol (96.2% vs. 96.9%,  P  > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed.","['Subjects endoscopically diagnosed with  H. pylori  infection', 'Helicobacter pylori  infection', '233 participants']","['modified quadruple', 'Amoxicillin or tetracycline', 'rabeprazole 20 mg bid, amoxicillin 1\xa0g bid', 'modified quadruple- and bismuth-containing quadruple therapy', 'rabeprazole, amoxicillin, metronidazole, and bismuth', 'metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT']","['acceptable eradication rate', 'Adverse events', 'amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates', 'efficacy and safety', 'Overall compliance', 'Antimicrobial resistance', 'Antibiotic resistance', 'Rates of eradication success and adverse events', 'modified intention-to-treat']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0992611', 'cui_str': 'Metronidazole 500 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",233.0,0.0671799,"Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%,  P  = .37), modified intention-to-treat (96.2% vs. 96%,  P  > .99), and per-protocol (96.2% vs. 96.9%,  P  > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed.","[{'ForeName': 'Chang Seok', 'Initials': 'CS', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Hae Min', 'Initials': 'HM', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Woon Geon', 'Initials': 'WG', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Institute of New Frontier Research, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Soh', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ho Suk', 'Initials': 'HS', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ji Taek', 'Initials': 'JT', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Suk Pyo', 'Initials': 'SP', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Suk', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Institute of New Frontier Research, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Gwang Ho', 'Initials': 'GH', 'LastName': 'Baik', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine , Chuncheon, Korea.'}]",Gut microbes,['10.1080/19490976.2020.1754118']
21,32347779,"Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized TrialA. E. Abolazm, A. S. El-Hefnawy, M. Laymon, A. B. Shehab-El-Din and A. M. Elshal  J Urol  2020;  203:  792-801.",,2020,,[],['Re: Ejaculatory Hood Sparing Versus Standard Laser Photoselective Vaporization'],[],[],"[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]",[],,0.41547,,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}]",The Journal of urology,['10.1097/JU.0000000000001093']
22,32343967,Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.,"BACKGROUND


Peak inspiratory flow (PIF) has been proposed as a measure to assess a patient's ability to use dry powder inhalers (DPIs). However, robust quality criteria to determine a repeatability limit for measuring PIF are lacking.
RESEARCH QUESTIONS


What are the repeatability limits for measuring PIF? What is the relationship between PIF measured using the In-Check DIAL device at Diskus (GlaxoSmithKline; PIF D ) and HandiHaler (Boehringer Ingelheim; PIF HH ) resistances?
STUDY DESIGN AND METHODS


Data from a randomized, controlled, phase 3 trial (study 0149; see Clinical Trial Registration data) were used to define repeatability limits for PIF. In addition, a model to characterize the relationship between PIF measured with the In-Check DIAL device at PIF D  and PIF HH  was defined using data from two randomized, controlled, phase 3 trials (studies 0128 and 0149).
RESULTS


In study 0128, the mean values (SD) for PIF at zero resistance and PIF HH  were 84.6 (33.4) and 57.3 (26.1) L/min, respectively. In study 0149, the mean values (SD) for PIF D  and PIF HH  were 42.4 (11.2) and 29.0 (8.3) L/min, respectively. At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 and < 3 L/min, respectively. The repeatability limit was determined as 10 and 5 L/min for PIF D  and PIF HH , respectively. Modeling the relationship between PIF D  and PIF HH , after controlling for significant covariates, demonstrated that a PIF D  value of 60 L/min was approximately equivalent to PIF HH  of 40 L/min.
INTERPRETATIONS


This analysis demonstrated that the two highest values of PIF using the In-Check DIAL device among three inspiratory efforts, met the repeatability limit. Altogether, these data provide guidance for measuring PIF against the simulated resistance of a specific DPI in clinical practice and research studies.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov; Nos.: NCT02518139 (study 0128) and NCT03095456 (study 0149); URL: www.clinicaltrials.gov.",2020,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.",[],['Peak inspiratory flow (PIF'],"['repeatability limit', 'mean values (standard deviation [SD]) for PIF at zero resistance and PIF HH', 'mean values (SD) for PIF D  and PIF HH', 'PIF D  and PIF HH']",[],"[{'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0429742', 'cui_str': 'Peak inspiratory flow rate'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0420994,"At the mean level, the mean difference between measurement attempts for PIF D  and PIF HH  was small, < 5 L/min and < 3 L/min, respectively.","[{'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Mahler', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Wake Forest University Medical Center, Winston-Salem, NC.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lombardi', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA. Electronic address: gcrater@theravance.com.'}]",Chest,['10.1016/j.chest.2020.03.072']
23,32353418,Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial.,"BACKGROUND


Fluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome.
RESEARCH QUESTION


Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes?
STUDY DESIGN AND METHODS


We conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first.
RESULTS


In modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (-1.37 L favoring the intervention arm; 0.65 ± 2.85 L intervention arm vs 2.02 ± 3.44 L usual care arm; P = .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P = .04) or mechanical ventilation (17.7% vs 34.1%; P = .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals.
INTERPRETATION


Physiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care.
CLINICAL TRIAL REGISTRATION


NCT02837731.",2020,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","['Sepsis Hypotension and Shock', 'septic shock patients', 'patients with septic shock', '13 hospitals in the United States and United Kingdom', 'Patients presented to Emergency Rooms with sepsis associated hypotension and anticipated Intensive Care Unit (ICU) admission']","['Usual Care', 'Fluid Response Evaluation']","['renal replacement therapy', 'fluid responsiveness', 'mechanical ventilation', 'safety signals', 'positive fluid balance at 72 hours or ICU discharge, whichever occurred first']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.241826,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","[{'ForeName': 'Ivor S', 'Initials': 'IS', 'LastName': 'Douglas', 'Affiliation': 'Pulmonary Science and Critical Care Medicine, Denver Health Medical Center and University of Colorado, Anschutz Medical Campus, Denver, CO. Electronic address: ivor.douglas@dhha.org.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Alapat', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, TX.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Corl', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Exline', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ohio State University Hospital, Columbus, OH.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Medicine and Nephrology, University of Surrey & Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Holder', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'NYU School of Medicine, New York, NY; Pulmonary and Critical Care Medicine, Bridgeport Hospital, Bridgeport, CT.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Sahatjian', 'Affiliation': 'Cheetah Medical, Wilmington, DE.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Seeley', 'Affiliation': 'Pulmonary, Critical Care Medicine and Allergy, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Pulmonary and Critical Care Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Cheetah Medical, Wilmington, DE; Department of Anesthesiology, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA.'}]",Chest,['10.1016/j.chest.2020.04.025']
24,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
25,32372387,Comparing the Potential for Irritation of a Ceramide-Based Moisturizer with a Urea-Based Moisturizer for Pediatric Atopic Dermatitis.,"INTRODUCTION


Moisturizers are one of the mainstays of the topical treatment of atopic dermatitis (AD). One of the adverse effects of moisturizers is skin irritation, especially on excoriated AD skin. We compared the potential for irritation of two commercially available moisturizer products for the treatment of AD: a ceramide-based moisturizer (Ceradan ®  Cream; Hyphens Pharma Pte Ltd, Singapore) and a urea 5% moisturizer (Aqurea Lite Cream; ICA Pharma Pte Ltd, Singapore).
METHODS


We performed a prospective single-blind randomized controlled study recruiting AD patients aged between 8 and 16 years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae. Subjects were randomized to receive the ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa. Subjects were asked to grade the immediate skin irritation of both creams on a standard visual analogue scale (VAS) and which cream they would prefer to use as a daily moisturizer. Primary outcome was the mean irritant score of each cream, and secondary outcome was the subjects' preference of either cream as their daily moisturizer.
RESULTS


A total of 42 participants were enrolled with a mean age of 11 years 5 months. The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035). More participants also preferred the ceramide-based cream over urea 5% cream (62% versus 38%) as their daily moisturizer, but this did not reach statistical significance (p = 0.164).
CONCLUSIONS


A ceramide-based moisturizer may be considered as a suitable choice for children to minimize irritation from moisturizer treatment for AD.",2020,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","['Pediatric Atopic Dermatitis', 'AD patients aged between 8 and 16\xa0years with symmetrical or near symmetrical scratch marks (excoriations) of at least grade 2 to 3 severity score, according to the Eczema Area and Severity Index (EASI), over bilateral antecubital fossae', '42 participants were enrolled with a mean age of 11\xa0years 5\xa0months']","['ceramide-based moisturizer to either the left or right antecubital fossa or urea 5% cream to the other antecubital fossa', 'Ceramide-Based Moisturizer with a Urea-Based Moisturizer']","['standard visual analogue scale (VAS', 'mean irritant score of each cream', ""subjects' preference of either cream as their daily moisturizer"", 'mean VAS score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0446523', 'cui_str': 'Antecubital fossa (surface region)'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",42.0,0.0323502,"The ceramide-based cream had a significantly lower mean VAS score (mean 0.69, SD = 1.63) for irritation compared with urea 5% cream (1.43, SD = 1.64) (p = 0.035).","[{'ForeName': 'Valerie Pui Yoong', 'Initials': 'VPY', 'LastName': 'Ho', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore. valerie.ho.p.y@singhealth.com.sg.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ma', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Hui Min', 'Initials': 'HM', 'LastName': 'Liew', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Michelle Si Ying', 'Initials': 'MSY', 'LastName': 'Ng', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Mark Jean Aan', 'Initials': 'MJA', 'LastName': 'Koh', 'Affiliation': ""Dermatology Service, KK Women's and Children's Hospital, Singapore, Singapore.""}]",Dermatology and therapy,['10.1007/s13555-020-00388-6']
26,32372290,Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.,"INTRODUCTION


The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials.
METHODS


Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin 25 mg (n = 5057), or placebo (n = 4904). The dataset comprised 15 randomized phase I-III trials, an extension trial and dose escalation studies. Adverse events (AEs) were assessed descriptively in participants who took ≥ 1 dose of study drug. AE incidence rates per 100 patient-years were calculated to adjust for differences in drug exposure between trials.
RESULTS


Total exposure was 16,480 and 7857 patient-years in the pooled empagliflozin 10/25 mg and placebo groups, respectively. The incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs was similar across groups. The frequency of serious AEs requiring hospitalization was 18.6% for the empagliflozin 10/25 mg group and 21.3% for the placebo group. The empagliflozin 10/25 mg group was not associated with a higher rate of confirmed hypoglycemia versus placebo, except in patients co-administered insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The incidence of events consistent with urinary tract infections (UTI) was also similar for the empagliflozin 10/25 mg group versus placebo (9.27 vs. 9.70/100 patient-years, respectively). History of UTI was identified as a risk factor for UTI during treatment. Events consistent with genital infections occurred more frequently with empagliflozin 10/25 mg than placebo (3.54 vs. 0.95/100 patient-years, respectively). The frequency of AEs consistent with volume depletion was similar across groups, but higher with empagliflozin 10/25 mg than placebo in patients aged 75 to < 85 years and those on loop diuretics at baseline.
CONCLUSION


This comprehensive analysis confirms that both empagliflozin 10 mg and 25 mg are well tolerated in patients with T2DM, reinforcing the established clinical safety profile of empagliflozin.",2020,Events consistent with genital infections occurred more frequently with empagliflozin,"['10\xa0mg (n\u2009=\u20094858', 'Total exposure was 16,480 and 7857 patient-years in the pooled', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'Pooled data from 20 trials were analyzed for patients with T2DM treated with', 'patients with T2DM']","['empagliflozin 25\xa0mg (n\u2009=\u20095057), or placebo', 'Empagliflozin', 'empagliflozin', 'placebo']","['AE incidence rates', 'genital infections', 'higher rate of confirmed hypoglycemia', 'safety and tolerability', 'incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs', 'Adverse events (AEs', 'incidence of events consistent with urinary tract infections (UTI', 'frequency of AEs consistent with volume depletion', 'frequency of serious AEs requiring hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.314442,Events consistent with genital infections occurred more frequently with empagliflozin,"[{'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Kinduryte Schorling', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Iliev', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany. hristo.iliev@boehringer-ingelheim.com.'}]",Advances in therapy,['10.1007/s12325-020-01329-7']
27,32379303,Personalised Adherence Support for Maintenance Treatment of Inflammatory Bowel Disease: A Tailored Digital Intervention to Change Adherence-related Beliefs and Barriers.,"BACKGROUND AND AIMS


Interventions to improve adherence to medication may be more effective if tailored to the individual, addressing adherence-related beliefs about treatment and overcoming practical barriers to daily use. We evaluated whether an algorithm, tailoring support to address perceptual and practical barriers to adherence, reduced barriers and was acceptable to patients with inflammatory bowel disease [IBD].
METHODS


Participants with IBD, prescribed azathioprine and/or mesalazine, were recruited via patient groups, social media, and hospital clinics and allocated to Intervention or Control Groups. The online intervention comprised messages tailored to address beliefs about IBD and maintenance treatment and to provide advice on overcoming practical difficulties with taking regular medication. The content was personalised to address specific perceptual and practical barriers identified by a pre-screening tool. Validated questionnaires assessed barriers to adherence and related secondary outcomes at baseline and at 1 and 3 months of follow-up.
RESULTS


A total of 329 participants were allocated to the Intervention [n = 153] and Control [n = 176] Groups; just under half [46.2%] completed follow-up. At 1 and 3 months, the Intervention Group had significantly fewer concerns about IBD medication [p ≤0.01]; and at three months, fewer doubts about treatment necessity, fewer reported practical barriers, and higher reported adherence [p <0.05]. Relative to controls at follow-up, the Intervention Group were more satisfied with information about IBD medicines, and viewed pharmaceuticals in general more positively. Questionnaires, interviews, and intervention usage indicated that the intervention was acceptable.
CONCLUSIONS


Personalised adherence support using a digital algorithm can help patients overcome perceptual barriers [doubts about treatment necessity and medication concerns] and practical barriers to adherence.",2020,"At 1 and 3 months, the Intervention Group had significantly fewer concerns about IBD medication [p ≤0.01]; and at three months, fewer doubts about treatment necessity, fewer reported practical barriers, and higher reported adherence [p <0.05].","['329 participants were allocated to the Intervention [n = 153] and Control [n = 176', 'Inflammatory Bowel Disease', 'patients with inflammatory bowel disease [IBD', 'Participants with IBD, prescribed']","['azathioprine', 'mesalazine']",['concerns about IBD medication'],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",329.0,0.0254986,"At 1 and 3 months, the Intervention Group had significantly fewer concerns about IBD medication [p ≤0.01]; and at three months, fewer doubts about treatment necessity, fewer reported practical barriers, and higher reported adherence [p <0.05].","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Chapman', 'Affiliation': 'UCL School of Pharmacy, Centre for Behavioural Medicine, London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': 'UCL School of Pharmacy, Centre for Behavioural Medicine, London, UK.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'St-Clair Jones', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital, Pharmacy Department, Brighton, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'Institute for Digestive Diseases, University College London, London, UK.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chater', 'Affiliation': 'UCL School of Pharmacy, Centre for Behavioural Medicine, London, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'UCL School of Pharmacy, Centre for Behavioural Medicine, London, UK.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjz034']
28,32371830,Effects of intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement on oxygenation and respiratory mechanics during laparoscopic gynaecological surgery: A randomised controlled trial.,"BACKGROUND


The creation of pneumoperitoneum during laparoscopic surgery can lead to adverse effects on the respiratory system. Positive end-expiratory pressure (PEEP) plays an important role in mechanical ventilation during laparoscopic surgery.
OBJECTIVE


To evaluate whether PEEP setting guided by oesophageal pressure (Poeso) measurement would affect oxygenation and respiratory mechanics during laparoscopic gynaecological surgery.
DESIGN


A randomised controlled study.
SETTING


A single-centre trial from March 2018 to June 2018.
PATIENTS


Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2 h.
INTERVENTION


PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5 cmH2O (control group).
MAIN OUTCOME MEASURES


Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60 min after initiation of pneumoperitoneum (T1 and T2, respectively).
RESULTS


PEEP during pneumoperitoneum was significantly higher in the intervention group than in the control group (T1, 12.5 ± 1.9 vs. 5.0 ± 0.0 cmH2O and T2, 12.4 ± 1.9 vs. 5.0 ± 0.0 cmH2O, both P < 0.001). Partial pressures of oxygen decreased significantly from baseline during pneumoperitoneum in the control group but not in the intervention group. Nevertheless, the changes in partial pressures of oxygen did not differ between groups. Compliance of the respiratory system (CRS) significantly decreased and driving pressure significantly increased during pneumoperitoneum in both groups. However, the changes in CRS and driving pressure were significantly less in the intervention group. Transpulmonary pressure during expiration was maintained in the intervention group while it decreased significantly in the control group.
CONCLUSION


PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03256396.",2020,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","['laparoscopic gynaecological surgery', 'A single-centre trial from March 2018 to June 2018', 'Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2\u200ah']","['intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement', 'PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5\u200acmH2O (control group', 'PEEP setting guided by oesophageal pressure (Poeso) measurement']","['oxygenation and respiratory mechanics', 'CRS and driving pressure', 'driving pressure', 'partial pressures of oxygen', 'Partial pressures of oxygen', 'Positive end-expiratory pressure (PEEP', 'Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60\u200amin after initiation of pneumoperitoneum (T1 and T2, respectively', 'Transpulmonary pressure during expiration']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0807495', 'cui_str': 'Positive end expiratory pressure setting'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",44.0,0.183262,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","[{'ForeName': 'Annop', 'Initials': 'A', 'LastName': 'Piriyapatsom', 'Affiliation': 'From the Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand (AP, SP).'}, {'ForeName': 'Sanchai', 'Initials': 'S', 'LastName': 'Phetkampang', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001204']
29,32376326,Family History Influences the Effectiveness of Home Exercise in Older People With Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To investigate whether a family history of low back pain (LBP) influences patient outcomes and treatment effects following home exercises in older people with chronic LBP.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Local community.
PARTICIPANTS


People older than 55 years with chronic LBP (N=60).
INTERVENTIONS


Participants in the intervention group completed video game exercises for 60 minutes 3 times per week for 8 weeks. Participants in the control group were instructed to maintain their usual levels of activity and care seeking behaviors.
MAIN OUTCOMES MEASURES


Participants indicated whether any of their immediate family members had a history of ""any"" LBP or ""activity-limiting"" LBP at baseline. We collected self-reported measures of pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement and/or reinjury, and falls efficacy at baseline, 8 weeks, 3 months, and 6 months. We performed regression analyses to determine whether a family history of LBP predicted patient outcomes and moderated the effects of home exercise.
RESULTS


Participants with a family history of any LBP were less likely to be highly active than those without a family history (odds ratio, 0.08; 95% CI, 0.01-0.42; P=.003). Home-based video game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78; 95% CI, 0.56-3.00; P=.006) but not in those with a family history (β=-0.17; 95% CI, -2.56 to 2.21; P=.880) (interaction P=.049). A family history of LBP did not influence the remaining patient outcomes or treatment effects.
CONCLUSIONS


A family history of LBP appears to negatively influence physical activity levels in older people with chronic LBP. Further, home-based video game exercises appear to be beneficial for older people with chronic LBP that do not have a family history of LBP.",2020,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","['older people with chronic LBP', 'Local community', 'People over 55 years old with chronic LBP', 'OF HOME-EXERCISE IN OLDER PEOPLE WITH CHRONIC LOW BACK PAIN']","['home-exercises', 'video-game exercises']","['pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement/re-injury, and falls-efficacy', ""history of 'any' LBP or 'activity-limiting' LBP"", 'physical activity levels']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0788307,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, NSW, Australia. Electronic address: joshua.zadro@sydney.edu.au.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Shirley', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Tom I L', 'Initials': 'TIL', 'LastName': 'Nilsen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway; Clinic of Anaesthesia and Intensive Care, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.019']
30,32378072,Cetuximab Maintenance Therapy in Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer: A Single-Institute Prospective Study.,"INTRODUCTION


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


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


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


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


Retrospectively registered, 2019/10/02, Chinese Clinical Trial Registry, ChiCTR number 1900026360.",2020,"Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3-14.1; DCR 28.6%; ORR 4.8%).","['untreated patients with mCRC RBWT', 'patients after effective completion of first-line induction therapy', 'enrolled untreated patients with mCRC RBWT who received', '79 enrolled patients, 72 completed first-line treatment effectively (DCR 91.1%, ORR 63.9%) and 44 entered maintenance\xa01', 'Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer', 'patients with treatment response either entered observation (stop treatment) or']","['cetuximab maintenance therapy', 'first-line cetuximab plus FOLFIRI therapy', 'Cetuximab Maintenance Therapy', 'maintenance treatment\xa01 (cetuximab plus irinotecan', 'Cetuximab plus FOLFIRI (leucovorin, fluorouracil, and irinotecan']","['disease control rate (DCR), objective remission rate (ORR), and progression-free survival (PFS', 'Rash acneiform, mucositis, and asthenia', 'failure-free survival (FFS', 'efficacy and safety', 'Safety events', 'FFS', 'Median FFS (mFFS']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0175167', 'cui_str': 'Acneiform eruption'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",79.0,0.0395639,"Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3-14.1; DCR 28.6%; ORR 4.8%).","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Baoyu', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Dongta', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Mengxin', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Jinhuo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Peifeng', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China. linxiaoyan288@gmail.com.""}]",Advances in therapy,['10.1007/s12325-020-01360-8']
31,32382931,Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial.,"OBJECTIVE


The aim of this study is to investigate the use of a porcine-derived acellular dermal matrix (MD) in root coverage procedures combined with extended coronally positioned flap (eCAF), in comparison to the subepithelial connective tissue graft (SCTG) associated with the eCAF.
MATERIAL AND METHODS


Eighteen adult patients presenting bilateral type 1 gingival recession were randomly assigned to SCTG or MD groups. Clinical and patient-based outcomes were recorded at 3 and 6 months after the surgical procedure.
RESULTS


Both groups showed a significant reduction in the mean recession height of 3.33 ± 0.89 mm to 1.24 ± 1.10 mm (MD) and 3.21 ± 0.8 mm to 0.83 ± 0.86 mm (SCTG) without difference between groups. Six patients in the test group and eight in the control group obtained complete root coverage. The keratinized tissue height and thickness (KTT) showed a significant increase after 3 and 6 months in both groups. The average KTT gains were 0.39 ± 0.4 mm (MD) and 0.51 ± 0.5 mm (SCTG) (p < 0.05). Performing multivariate analysis suggests that MD addition to coronally advanced flaps may be similar to SCTG.
CONCLUSION


The MD had similar results in comparison to SCTG and in the context of reducing patient morbidity it can be used as an alternative for the treatment of gingival recessions.
CLINICAL RELEVANCE


The SCTG is the gold standard therapy for root coverage. The MD has been widely used in mucogingival surgery as a substitute for SCTG and proposed similar results. A substitute is very important for clinicians and patients. It will give a better postoperative and possibilities to treat multiples recession. (Clinicaltrials.gov Identifier: NCT03675334).",2020,The keratinized tissue height and thickness (KTT) showed a significant increase after 3 and 6 months in both groups.,['Eighteen adult patients presenting bilateral type 1 gingival recession'],"['coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft', 'extended coronally positioned flap (eCAF', 'porcine-derived acellular dermal matrix (MD', 'SCTG or MD']","['keratinized tissue height and thickness (KTT', 'average KTT gains', 'mean recession height', 'complete root coverage']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]",18.0,0.0577486,The keratinized tissue height and thickness (KTT) showed a significant increase after 3 and 6 months in both groups.,"[{'ForeName': 'Kleber Tanaka', 'Initials': 'KT', 'LastName': 'Suzuki', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Cristhiam', 'Initials': 'C', 'LastName': 'de Jesus Hernandez Martinez', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Milena Irie', 'Initials': 'MI', 'LastName': 'Suemi', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Daniela Bazan', 'Initials': 'DB', 'LastName': 'Palioto', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Michel Reis', 'Initials': 'MR', 'LastName': 'Messora', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Sérgio Luis Scombatti', 'Initials': 'SLS', 'LastName': 'de Souza', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Arthur Belem', 'Initials': 'AB', 'LastName': 'Novaes', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Flavia A', 'Initials': 'FA', 'LastName': 'Chaves Furlaneto', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Taba', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, and Periodontology, School of Dentistry of Ribeirão Preto, University of Sao Paulo, Av. do Cafe, s/n, Ribeirão Preto, São Paulo, CEP: 14040-904, Brazil. mtaba@usp.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03280-x']
32,32386761,Renal function and coronary bypass surgery in patients with ischemic heart failure.,"OBJECTIVE


Chronic kidney disease is a known risk factor in cardiovascular disease, but its influence on treatment effect of bypass surgery remains unclear. We assessed the influence of chronic kidney disease on 10-year mortality and cardiovascular outcomes in patients with ischemic heart failure treated with medical therapy (medical treatment) with or without coronary artery bypass grafting.
METHODS


We calculated the baseline estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration formula, chronic kidney disease stages 1-5) from 1209 patients randomized to medical treatment or coronary artery bypass grafting in the Surgical Treatment for IsChemic Heart failure trial and assessed its effect on outcome.
RESULTS


In the overall Surgical Treatment for IsChemic Heart failure cohort, patients with chronic kidney disease stages 3 to 5 were older than those with stages 1 and 2 (66-71 years vs 54-59 years) and had more comorbidities. Multivariable modeling revealed an inverse association between estimated glomerular filtration rate and risk of death, cardiovascular death, or cardiovascular rehospitalization (all P < .001, but not for stroke, P = .697). Baseline characteristics of the 2 treatment arms were equal for each chronic kidney disease stage. There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P < .0001; stage 3: hazard ratio, 0.76; confidence interval, 0.53-0.96, P = .03). These data were inconclusive in stages 4 and 5 for insufficient patient numbers (N = 28). There was no significant interaction of estimated glomerular filtration rate with the treatment effect of coronary artery bypass grafting (P = .25 for death and P = .54 for death or cardiovascular rehospitalization).
CONCLUSIONS


Chronic kidney disease is an independent risk factor for mortality in patients with ischemic heart failure with or without coronary artery bypass grafting. However, mild to moderate chronic kidney disease does not appear to influence long-term treatment effects of coronary artery bypass grafting.",2020,"There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P ","['patients with ischemic heart failure', 'patients with ischemic heart failure treated with medical therapy (medical treatment) with or without coronary artery bypass grafting', '1209 patients randomized to', 'patients with chronic kidney disease stages 3 to 5 were older than those with stages 1 and 2 (66-71\xa0years vs 54-59\xa0years) and had more comorbidities', 'patients with ischemic heart failure with or without coronary artery bypass grafting']","['coronary artery bypass grafting', 'medical treatment or coronary artery bypass grafting', 'coronary bypass surgery']","['chronic kidney disease stage', 'Renal function', 'glomerular filtration rate and risk of death, cardiovascular death, or cardiovascular rehospitalization', 'death or cardiovascular rehospitalization', 'glomerular filtration rate', '10-year mortality and cardiovascular outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1209.0,0.0554792,"There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P ","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany. Electronic address: doenst@med.uni-jena.de.'}, {'ForeName': 'Haissam', 'Initials': 'H', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Malcom Randal VAMC, Gainesville, Fla.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Conn.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil; Department of Cardiology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.02.136']
33,32379631,Effect of reflexology on anxiety and sleep of informal cancer caregiver: Randomized controlled trial.,"OBJECTIVES


The study was conducted with the aim of evaluating the short-term effect of foot reflexology on sleep and anxiety of informal caregivers.
METHOD


The study was a double-blind placebo-controlled study and conducted in an oncology unit of a university hospital. Participants were the informal caregivers of cancer patients. Reflexology and placebo intervention had applied for three consequent days. State Anxiety Inventory (SAI, 20-80 points) and Richard-Campbell Sleep Questionnaire (RCSQ, Visual Analog Scale) was used for data collection before and after the intervention. Data were analyzed with SPSS v25 software.
RESULTS


Participants (n = 66, 40.17 ± 13.36 years old, ten males) were caring for the patients for 7.66 ± 6.34 months. There weren't any significant differences between the groups for SAI and RCSQ scores before the interventions. The SAI scores were found 38.91 ± 5.63 in the reflexology group and 46.30 ± 11.29 in the placebo group and the RCSQ scores were found 409.55 ± 50.08 in the reflexology group and 441.82 ± 35.51 in the placebo group. There were significant differences between the groups for SAI (p = 0.004) and RCSQ (p = 0.001) scores after the intervention. It was found that reflexology has a large effect on Anxiety (f 2  = 0.555) and a medium effect on sleep (f 2  = 0.238).
CONCLUSION


Foot reflexology was found as an effective intervention to reduce anxiety and improve the quality of sleep of informal cancer caregivers. The effect of placebo on reducing the anxiety of informal caregivers was found, but it wasn't as effective as reflexology.",2020,There were significant differences between the groups for SAI (p = 0.004) and RCSQ (p = 0.001) scores after the intervention.,"['Participants (n\xa0', 'Participants were the informal caregivers of cancer patients', 'oncology unit of a university hospital', '66, 40.17\xa0±\xa013.36 years old, ten males) were caring for the patients for 7.66\xa0±\xa06.34 months']","['Reflexology and placebo intervention', 'reflexology', 'foot reflexology', 'placebo']","['SAI and RCSQ scores', 'quality of sleep', 'State Anxiety Inventory (SAI, 20-80 points) and Richard-Campbell Sleep Questionnaire (RCSQ, Visual Analog Scale', 'anxiety and sleep of informal cancer caregiver', 'RCSQ', 'SAI scores', 'RCSQ scores']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0474843,There were significant differences between the groups for SAI (p = 0.004) and RCSQ (p = 0.001) scores after the intervention.,"[{'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Toygar', 'Affiliation': 'Ege University Faculty of Nursing Internal Nursing Department, Turkey. Electronic address: ismail.toygar1@gmail.com.'}, {'ForeName': 'Öznur Usta', 'Initials': 'ÖU', 'LastName': 'Yeşilbalkan', 'Affiliation': 'Ege University Faculty of Nursing Internal Nursing Department, Turkey. Electronic address: oznurustayesilbalkan@hotmail.com.'}, {'ForeName': 'Yasemin Güzel', 'Initials': 'YG', 'LastName': 'Malseven', 'Affiliation': 'Ege University Faculty of Medicine Tülay Aktaş Oncology Hospital, Turkey. Electronic address: guzelyas@hotmail.com.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Sönmez', 'Affiliation': 'Ege University Faculty of Medicine Tülay Aktaş Oncology Hospital, Turkey. Electronic address: esu_07@mynet.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101143']
34,32379676,Effects of hydrotherapy with massage on serum nerve growth factor concentrations and balance in middle aged diabetic neuropathy patients.,"BACKGROUND


and purpose: Nerve growth factor (NGF) concentrations and balance are reduced in diabetic neuropathy (DN) patients. We examined the effects of hydrotherapy and massage on NGF, balance and glycemic markers in middle aged DN patients.
MATERIALS AND METHODS


Patients were randomly assigned into four groups, aquatic exercise (AE; n = 10), AE + massage (AM; n = 10), massage (M; n = 10) or control (C; n = 9). Subjects in AE and AM groups exercised three times per week. Subjects in the AM and M groups received massage during the same period. Glycemic markers, NGF and balance were evaluated prior to and following the interventions.
RESULTS


NGF, glycemic markers and dynamic balance improved in AE, AM and M groups; however, the increase was greater following the AM trial (p < 0.01) when compared to the other trials.
CONCLUSION


A combination of hydrotherapy and massage enhances NGF concentrations, balance and the glycemic profile compared to hydrotherapy or massage alone.",2020,"RESULTS


NGF, glycemic markers and dynamic balance improved in AE, AM and M groups; however, the increase was greater following the AM trial (p < 0.01) when compared to the other trials.
","['middle aged DN patients', 'Patients', 'middle aged diabetic neuropathy patients', 'diabetic neuropathy (DN) patients']","['aquatic exercise (AE; n\xa0=\xa010), AE\xa0+\xa0massage (AM; n\xa0=\xa010), massage (M; n\xa0=\xa010) or control', 'hydrotherapy and massage', 'hydrotherapy with massage']","['NGF concentrations, balance and the glycemic profile', 'Glycemic markers, NGF and balance', 'NGF, glycemic markers and dynamic balance', 'Nerve growth factor (NGF) concentrations and balance', 'NGF, balance and glycemic markers']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",,0.0180362,"RESULTS


NGF, glycemic markers and dynamic balance improved in AE, AM and M groups; however, the increase was greater following the AM trial (p < 0.01) when compared to the other trials.
","[{'ForeName': 'Pouria', 'Initials': 'P', 'LastName': 'Shourabi', 'Affiliation': 'Department of Corrective Exercises, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Mohamad S', 'Initials': 'MS', 'LastName': 'Motevalli', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Hedayati', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Centre for Health and Exercise Science Research, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: Rashidlamir@um.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101141']
35,32379680,"Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial.","AIM


To investigate the effects of kinesio tape (KT) application on pain, anxiety, and menstrual complaints in women with PD and compare this application with control and sham tape (ST).
METHODS


Fifty-one women with PD were randomized into three groups: KT, ST, and control groups. No tape application was performed in the control group. KT was applied on the sacral and suprapubic regions with the ligament technique in the KT group, while it was applied on the trochanter major with no technique in the ST group. Pain, anxiety level, and menstrual complaints were assessed before and after the applications.
RESULTS


The decreases in pain, anxiety levels, and some menstrual complaints after the application were higher in the KT group than those in the other two groups (p < 0.05).
CONCLUSION


KT application seems to be an effective method in decreasing pain, anxiety level, and some menstrual complaints in women with PD.",2020,"The decreases in pain, anxiety levels, and some menstrual complaints after the application were higher in the KT group than those in the other two groups (p < 0.05).
","['women with primary dysmenorrhea', 'Fifty-one women with PD', 'women with PD']","['kinesio tape application', 'kinesio tape (KT) application', 'control and sham tape (ST']","['pain, anxiety levels, and some menstrual complaints', 'pain, anxiety level', 'pain, anxiety, and menstrual complaints', 'Pain, anxiety level, and menstrual complaints']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",51.0,0.0244641,"The decreases in pain, anxiety levels, and some menstrual complaints after the application were higher in the KT group than those in the other two groups (p < 0.05).
","[{'ForeName': 'Seyda', 'Initials': 'S', 'LastName': 'Toprak Celenay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Sciences Faculty, Ankara Yildirim Beyazit University Ankara, Turkey. Electronic address: sydtoprak@hotmail.com.'}, {'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Kavalci', 'Affiliation': 'Department of Therapy and Rehabilitation, Vocational School of Health Services, Gumushane University, Gumushane, Turkey. Electronic address: kavalcibasak@gmail.com.'}, {'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Karakus', 'Affiliation': 'Department of Occupational Therapy, Health Sciences Faculty, Cankiri Karatekin University, Cankiri, Turkey. Electronic address: aykarakus_02@hotmail.com.tr.'}, {'ForeName': 'Afra', 'Initials': 'A', 'LastName': 'Alkan', 'Affiliation': 'Faculty of Medicine, Department of Biostatistics, Ankara Yildirim Beyazit University, Ankara, Turkey. Electronic address: afra.alkan@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101148']
36,32379683,"The effect of bergamot orange essence on anxiety, salivary cortisol, and alpha amylase in patients prior to laparoscopic cholecystectomy: A controlled trial study.","BACKGROUND AND PURPOSE


This study aimed to determine the effect of bergamot orange essence on anxiety, salivary cortisol, and alpha amylase in patients prior to laparoscopic cholecystectomy.
MATERIAL AND METHODS


This clinical trial with pre-post design was conducted on 60 candidates for cholecystectomy. The participants were randomly divided into an intervention and a control group. The intervention group participants underwent aromatherapy using two drops of 3% bergamot orange essence, while the control group ones inhaled two drops of odourless grape seed oil. Anxiety mean score and salivary cortisol and alpha amylase levels were measured before and after the intervention.
RESULTS


A significant difference was found between the groups regarding anxiety (F = 9.00, p = 0.004) and alpha amylase level (F = 9.46, p = 0.003) after the intervention.
CONCLUSION


Bergamot orange essence decreased anxiety and salivary alpha amylase level. Therefore, this method can be used as a complementary technique to reduce patients' anxiety prior to laparoscopic cholecystectomy surgery.
IRCT REGISTRATION NUMBER


IRCT20171113037428N2. It is available in following website: https://www.irct.ir/trial/27696 REGISTRATION DATE: 03/25/2018.",2020,"A significant difference was found between the groups regarding anxiety (F = 9.00, p = 0.004) and alpha amylase level (F = 9.46, p = 0.003) after the intervention.
","['patients prior to laparoscopic cholecystectomy', '60 candidates for cholecystectomy', ""patients' anxiety prior to laparoscopic cholecystectomy surgery""]","['bergamot orange essence', 'aromatherapy using two drops of 3% bergamot orange essence, while the control group ones inhaled two drops of odourless grape seed oil']","['anxiety', 'Anxiety mean score and salivary cortisol and alpha amylase levels', 'alpha amylase level', 'anxiety, salivary cortisol, and alpha amylase', 'anxiety and salivary alpha amylase level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1258049', 'cui_str': 'Citrus bergamia'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0458160', 'cui_str': 'grape seed oil'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",60.0,0.0353528,"A significant difference was found between the groups regarding anxiety (F = 9.00, p = 0.004) and alpha amylase level (F = 9.46, p = 0.003) after the intervention.
","[{'ForeName': 'Nilofar', 'Initials': 'N', 'LastName': 'Pasyar', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Masoume', 'Initials': 'M', 'LastName': 'Rambod', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: rambodm@sums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Araghi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101153']
37,32388511,Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants.,"BACKGROUND AND OBJECTIVES


Nasal continuous positive airway pressure (NCPAP) is a useful method of respiratory support after extubation. However, some infants fail despite CPAP use and require reintubation. Some evidence suggests that synchronized nasal intermittent positive pressure ventilation (NIPPV) may decrease extubation failure in preterm infants. Nonsynchronized NIPPV (NS-NIPPV) is being widely used in preterm infants without conclusive evidence of its benefits and side effects. Our aim was to evaluate whether NS-NIPPV decreases extubation failure compared with NCPAP in ventilated very low birth weight infants (VLBWI) with respiratory distress syndrome (RDS).
METHODS


Randomized controlled trial of ventilated VLBWI being extubated for the first time. Before extubation, infants were randomized to receive NCPAP or NS-NIPPV. Primary outcome was the need for reintubation within 72 h.
RESULTS


220 infants were included. The mean ± SD birth weight was 1,027 ± 256 g and gestational age 27.8 ± 1.9 weeks. Demographic and clinical characteristics were similar in both groups. Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98. The frequency of deaths, bronchopulmonary dysplasia, intraventricular hemorrhage, air leaks, necrotizing enterocolitis and duration of respiratory support did not differ between groups.
CONCLUSIONS


In this population of VLBWI, NS-NIPPV did not decrease extubation failure after RDS compared with NCPAP.",2020,"Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98.","['after Extubation of VLBW Infants', 'ventilated very low birth weight infants (VLBWI) with respiratory distress syndrome (RDS', 'preterm infants']","['Nonsynchronized NIPPV (NS-NIPPV', 'Nasal continuous positive airway pressure (NCPAP', 'NCPAP or NS-NIPPV', 'NS-NIPPV', 'Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP', 'ventilated VLBWI', 'NCPAP', 'synchronized nasal intermittent positive pressure ventilation (NIPPV']","['extubation failure', 'frequency of deaths, bronchopulmonary dysplasia, intraventricular hemorrhage, air leaks, necrotizing enterocolitis and duration of respiratory support', 'need for reintubation', 'mean ± SD birth weight', 'Extubation failure']","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",220.0,0.490166,"Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98.","[{'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Estay', 'Affiliation': 'Departamento de Neonatología, Pontificia Universidad Católica de Chile, Santiago, Chile, albertoestay@gmail.com.'}, {'ForeName': 'Gonzalo L', 'Initials': 'GL', 'LastName': 'Mariani', 'Affiliation': 'Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Claudio A', 'Initials': 'CA', 'LastName': 'Alvarez', 'Affiliation': 'Hospital Dr. Gustavo Fricke, Viña del Mar, Chile.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Milet', 'Affiliation': 'Hospital Dr. Sotero del Río, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Agost', 'Affiliation': 'Hospital Luis Carlos Lagomaggiore, Mendoza, Argentina.'}, {'ForeName': 'Claudia P', 'Initials': 'CP', 'LastName': 'Avila', 'Affiliation': 'Hospital San José, Santiago, Chile.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Roldan', 'Affiliation': 'Hospital Fernández, Buenos Aires, Argentina.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Abdala', 'Affiliation': 'Hospital Español, Mendoza, Argentina.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Keller', 'Affiliation': 'Hospital Universitario Austral, Buenos Aires, Argentina.'}, {'ForeName': 'María F', 'Initials': 'MF', 'LastName': 'Galletti', 'Affiliation': 'Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Departamento de Neonatología, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neonatology,['10.1159/000506164']
38,32389738,Topical tacalcitol as neoadjuvant for photodynamic therapy of acral actinic keratoses: An intra-patient randomized study.,"BACKGROUND


photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) is a well described and widely practiced treatment for actinic keratoses (AKs) on the head and face. Less is known about its use for AKs on upper extremities, which can be challenging for the dermatologist. The aim of our study was to compare the combination of topical tacalcitol before 5-ALA-PDT vs conventional 5-ALA-PDT for acral AKs in a prospective, randomized, intra-individual clinical study.
METHODS


patients with AKs of both upper extremities underwent keratolytic pretreatment with topical tacalcitol on the back of one hand and/or forearm (right vs left), randomly selected, for fifteen consecutive days before PDT. All patients underwent one session of 5-ALA-PDT. Visual analog scale for pain was assessed immediately after PDT session and any side effects were recorded after 3 days. Efficacy was evaluated with lesion count (LC) prior to treatment (V0) and 90 days (V1) after PDT.
RESULTS


twenty-one patients with multiple acral AKs were enrolled and completed the study. At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count was 44.4 %. There was no significant difference in VAS pain score between the two treatment modalities. Mild erythema was the only local side effect reported for both treatment regimens (52.4 %, tacalcitol plus PDT vs 42.9 %, PDT alone).
CONCLUSIONS


neoadjuvant use of topical tacalcitol might be useful to improve PDT efficacy, especially in hard-to-treat AKs on extremities.",2020,"At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count were 44.4% vs 31.5%, respectively).","['acral actinic keratoses', 'twenty-one patients with multiple acral AKs were enrolled and completed the study', 'patients with AKs of both upper extremities underwent keratolytic pretreatment with topical tacalcitol on the back of one hand and/or forearm (right vs left']","['topical tacalcitol before 5-ALA-PDT vs conventional 5-ALA-PDT', 'topical tacalcitol plus PDT', '5-ALA-PDT', 'photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA', 'Topical tacalcitol']","['VAS pain score', 'total lesion count', 'Efficacy', 'Mild erythema', 'Visual analog scale for pain', 'PDT efficacy']","[{'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0230332', 'cui_str': 'Both upper extremities'}, {'cui': 'C0022585', 'cui_str': 'Keratolytic agent'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0953467', 'cui_str': 'Tacalcitol'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0953467', 'cui_str': 'Tacalcitol'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",21.0,0.0428265,"At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count were 44.4% vs 31.5%, respectively).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Borgia', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Riso', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Catalano', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Marialorena', 'Initials': 'M', 'LastName': 'Coppola', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Giuffrida', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy. Electronic address: roberta_giuffrida@hotmail.it.'}, {'ForeName': 'Serafinella Patrizia', 'Initials': 'SP', 'LastName': 'Cannavò', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101803']
39,32381499,Ambulatory treatment of low-risk pulmonary embolism in fragile patients: a subgroup analysis of the multinational Home Treatment of Pulmonary Embolism (HoT-PE) Trial.,,2020,,['Fragile Patients'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0437401,,"[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hobohm', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Anušić', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center, Mainz, Germany.'}, {'ForeName': 'Stavros V', 'Initials': 'SV', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00663-2020']
40,32384175,Testosterone replacement therapy: Pre-treatment sex hormone-binding globulin levels and age may identify clinical subgroups.,"BACKGROUND


Testosterone replacement therapy (TRT) improves health in some but not all men with type 2 diabetes (T2DM) and adult-onset testosterone deficiency (TD). Such heterogeneity is compatible with the concept of patient subgroups that respond differently to therapy.
OBJECTIVES


Use baseline SHBG and age to identify putative subgroups that demonstrate different responses in variables such as waist circumference and HbA1c following TRT.
MATERIALS AND METHODS


A randomized double-blind trial approach was used to recruit and randomize men with T2DM and adult-onset TD into placebo and TRT-treated groups. Multiple regression was used to study differences between groups.
RESULTS


Baseline SHBG and change in SHBG (∆SHBG) were inversely related in the TRT group. Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or>median (28.1 nmol/L, 63 years, respectively). In men with both SHBG ≤ 28.1 nmol/L and age ≤ 63 years (subgroup 1), TRT was positively associated with ∆SHBG (c = 4.67, 95%CI 1.17-8.16, P = .010) while in those with SHBG > 28.1 nmol/L and age > 63.1 years (subgroup 4) the association was inverse (c = -7.07, 95%CI -11.64 to -2.49, P = .003). The association between TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score differed between subgroups; in subgroup 4 but not subgroup 1, the therapy was significantly associated with ∆waist circumference, ∆HbA1c and ∆IIEF.
DISCUSSION


Though the mechanism remains unclear, our finding of different responses to TRT in terms of change in waist circumference, HbA1c and IIEF score supports the concept of subgroups in men with T2DM and adult-onset TD.
CONCLUSION


Our approach may provide a basis for identifying men who will or will not derive benefit from TRT though a larger study is required.",2020,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","['randomise men with T2DM and adult onset TD into placebo and TRT treated groups', 'men with type 2 diabetes (T2DM) and adult onset testosterone deficiency (TD']","['Testosterone replacement therapy (TRT', 'Testosterone replacement therapy: Pre-treatment sex hormone binding globulin levels', 'TRT']","['TRT and change (∆) in waist circumference, HbA1c and International Index of Erectile Function (IIEF) score', 'waist circumference, HbA1c and IIEF score', 'Baseline SHBG and change in SHBG (∆SHBG']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.239468,"Both median values of SHBG and age mediated the effect of TRT on ∆SHBG depending on whether baseline values were ≤ or >median (28.1nmol/l, 63 years respectively).","[{'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Health Sciences, University Hospitals of North Midlands, Staffordshire University, Stoke-on-Trent, UK.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Hackett', 'Affiliation': 'School of Health and Life Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Strange', 'Affiliation': 'Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}]",Andrology,['10.1111/andr.12813']
41,32386082,Long-term mortality in the Intermediate care after emergency abdominal surgery (InCare) trial-A post-hoc follow-up study.,"BACKGROUND


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


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


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


We found no statistically significant difference in 6-year mortality between patients randomized to post-operative intermediate care or ward care after emergency abdominal surgery. However, we detected an absolute mortality risk reduction of 5% in favour of ward care, possibly due to random error.",2020,We found no statistically significant difference in six-year mortality between patients randomised to postoperative intermediate care or ward care afteremergency abdominal surgery.,"['A total of 286 patients were included', 'Patients undergoing emergency abdominal surgeryare at high risk of postoperative complications', 'After Emergency Abdominal Surgery (InCare) trial', 'adult patients undergoingemergency major laparoscopy or laparotomy with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 10 or more, who participated in the InCare trial from October 2010 to November 2012']","['postoperative intermediate care or standard surgical ward care', 'intermediate care versus standard surgical ward care']","['six-year mortality', 'cause six-year landmark mortality', 'mortality risk', 'time to death within six years after surgery']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",286.0,0.118646,We found no statistically significant difference in six-year mortality between patients randomised to postoperative intermediate care or ward care afteremergency abdominal surgery.,"[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Hansted', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care 4131, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Møller', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit Dpt. 7812, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Waldau', 'Affiliation': 'Department of Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Vester-Andersen', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit (ACES), Department of Anaesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13613']
42,32386940,Effects of Relaxation Techniques on Acute Postlaminectomy Pain: A Three-Arm Randomized Controlled Clinical Trial.,"PURPOSE


This study compared the effects of Benson relaxation with progressive muscle relaxation on pain severity after laminectomy.
DESIGN


Three-arm randomized, nonblinded, and parallel group trial.
METHODS


The study was conducted with 93 patients who underwent lumbar laminectomy. Patients were randomly assigned to three groups of Benson relaxation + routine care (n = 31), progressive muscle relaxation + routine care (n = 31), and routine care (n = 31). The two relaxation methods were performed at 2 (time 1), 12 (time 2), and 24 (time 3) hours after patients' regaining full consciousness in postoperative wards. Pain severity was assessed using the visual analog scale once before laminectomy, before and also 20 minutes after each relaxation session. In the control group, pain severity was measured at the same times as in the two relaxation groups.
FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group). However, no significant differences were found between Benson relaxation and progressive muscle relaxation in any of the three times.
CONCLUSIONS


The results suggest that both Benson and progressive muscle relaxation techniques can decrease acute postlaminectomy pain in the immediate postoperative period in adult patients.",2020,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","['adult patients', '93 patients who underwent lumbar laminectomy', 'Acute Postlaminectomy Pain']","['Relaxation Techniques', 'Benson relaxation with progressive muscle relaxation', 'Benson relaxation\xa0+\xa0routine care (n\xa0= 31), progressive muscle relaxation\xa0+\xa0routine care (n\xa0= 31), and routine care']","['acute postlaminectomy pain', 'Benson relaxation and progressive muscle relaxation', 'Pain severity', 'pain severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",93.0,0.0186028,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","[{'ForeName': 'Seyed Amir Hosein', 'Initials': 'SAH', 'LastName': 'Pishgooie', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fakhridokht', 'Initials': 'F', 'LastName': 'Akbari', 'Affiliation': 'Department of Nursing, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Keyvanloo Shahrestanaki', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Operating Room Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Momen', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran. Electronic address: Rezamomen88@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.02.004']
43,32379673,Effect of Sheetali pranayama on cardiac autonomic function among patients with primary hypertension - A randomized controlled trial.,"BACKGROUND


Sheetali pranayama is a cooling pranayama practiced for hypertension (HTN). The effects of Sheetali pranayama, as a solitary intervention on cardiovascular and autonomic changes in hypertension is unknown.
MATERIALS AND METHODS


The current study was conducted on 100 patients with HTN, randomly allocated to HTN with pranayama (Intervention group,n = 50) and HTN without pranayama (control group,n = 50) group. The intervention group practiced Sheetali pranayama for a period of 3 months. Blood pressure and HRV was assessed before and after the intervention.
RESULTS


Intervention group showed a significant (P < 0.05) reduction in blood pressure variables when compared to the control group. In short term HRV, time and frequency domain parameters showed parasympathetic dominance (P < 0.05) in the intervention group.
CONCLUSION


Sheetali pranayama significantly reduces blood pressure in patients with HTN and improved heart rate variability. Sheetali pranayama could thus be practiced in addition to regular medications for the efficacious management of HTN.",2020,"RESULTS


Intervention group showed a significant (P < 0.05) reduction in blood pressure variables when compared to the control group.","['100 patients with HTN', 'patients with primary hypertension']","['HTN with pranayama (Intervention group,n\xa0=\xa050) and HTN without pranayama (control group,n\xa0=\xa050) group', 'Sheetali pranayama', 'intervention group practiced Sheetali pranayama']","['blood pressure', 'cardiac autonomic function', 'Blood pressure and HRV', 'blood pressure variables', 'parasympathetic dominance', 'heart rate variability']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",100.0,0.0282326,"RESULTS


Intervention group showed a significant (P < 0.05) reduction in blood pressure variables when compared to the control group.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thanalakshmi', 'Affiliation': 'Department of Physiology, Saveetha Medical College, Thanadalam, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Maheshkumar', 'Affiliation': 'Department of Physiology and Biochemistry, Government Yoga and Naturopathy Medical College & Hospital, Arumbakkam, Chennai, India. Electronic address: doctor.mahesh1985@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kannan', 'Affiliation': 'Department of Medicine, Saveetha Medical College and Hospital, Thanadalam, Chennai, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sundareswaran', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences (AIIMS), Mangalagiri, Vijayawada, Andhra Pradesh, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Venugopal', 'Affiliation': 'Department of Yoga, Government Yoga and Naturopathy Medical College & Hospital, Arumbakkam, Chennai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Poonguzhali', 'Affiliation': 'Department of Community Medicine, Government Yoga and Naturopathy Medical College & Hospital, Arumbakkam, Chennai, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101138']
44,32379675,The effects of mindfulness-based empathy training on empathy and aged discrimination in nursing students: A randomised controlled trial.,"The aim of this study was to examine the effect of the Mindfulness-Based Empathy Training (MBET) program on nursing students' empathy and aged discrimination. This study was conducted as a randomized controlled trial (RCT). The 123 participants were randomly allocated to either the training group or the control group in a 1:1 ratio. Participants in the experimental group received the MBET. No intervention was applied to the participants in the control group. ""Descriptive Information Form"", ""Jefferson Empathy Scale (JSENS)"", and ""Age Discrimination Attitude Scale (ADAS)"" were used for data collection. General Linear Model repeated measures ANOVAs were used to determine the effect of the MBET on JSENS and ADAS. The analyses revealed that participants in the training group reported a significant increase in empathy level compared to the control group. No significant change in total aged discrimination scores and sub-scale of the ADAS were recorded in either group. This study indicated that empathy can be enhanced over an 8-week duration when mindfulness practices are integrated into a curriculum.",2020,The analyses revealed that participants in the training group reported a significant increase in empathy level compared to the control group.,"['123 participants', ""nursing students' empathy and aged discrimination"", 'empathy and aged discrimination in nursing students']","['mindfulness-based empathy training', 'Mindfulness-Based Empathy Training (MBET) program', 'MBET']","['total aged discrimination scores and sub-scale of the ADAS', 'empathy level']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",123.0,0.0275343,The analyses revealed that participants in the training group reported a significant increase in empathy level compared to the control group.,"[{'ForeName': 'Ganime', 'Initials': 'G', 'LastName': 'Can Gür', 'Affiliation': 'University of Pamukkale, Faculty of Health Science, Departman of Psychiatric Nursing, Denizli, 20000, Turkey. Electronic address: ganime_31@hotmail.com.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Yilmaz', 'Affiliation': 'University of Bingöl, Faculty of Health Science, Departman of Psychiatric Nursing, Bingöl, 12000, Turkey. Electronic address: emine.tog@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101140']
45,32385846,A Randomized Controlled Trial with a Medical Device Containing Sodium Hyaluronate and Nicotinic Acid to Increase the Efficacy of Ultraviolet Phototherapy in Psoriasis.,"INTRODUCTION


The dry and scaly skin of psoriatic patients decreases the efficacy of ultraviolet B (UVB) phototherapy. Different agents are used to facilitate the transmission of light, but most of these preparations are cosmetically unfavorable. We have tested a novel preparation containing sodium hyaluronate and nicotinic acid (UV Fotogel®; Pernix Ltd.) with the double aim to improve the efficacy of UVB phototherapy and assess the cosmetic acceptability of the preparation.
METHODS


Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received narrow-band UVB (NB-UVB) phototherapy. Prior to phototherapy, one side of the patient's body was treated with UV Fotogel while the other side served as a control. The other 46 patients used the preparation at their homes before regular sunbathing. The Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability were recorded. The median values with the 25th and 75th percentiles (25p and 75p, respectively) were determined for the UV Fotogel-treated and control sites and then compared.
RESULTS


The sides of the body to which UV Fotogel was applied prior to NB-UVB phototherapy had a significantly lower median L-PSI score than the non-treated control sides at the end of the treatment (1.0 [25p-75p: 0.0-2.0] vs. 2.0 [1.0-3.0], respectively). The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score. There was a significant reduction in the median L-PSI score of patients at the final visit compared to baseline (2.5 [25p-75p: 1.5-3.5] vs. 6.0 [6.0-7.0], respectively). Use of the preparation was not accompanied by considerable adverse effects, and the patients found it cosmetically acceptable. Application of UV Fotogel prior to sunbathing was well tolerated by the patients, and the cosmetic acceptability was also good.
CONCLUSION


UV Fotogel is potentially a useful device for enhancement of the efficacy of phototherapy in patients with psoriasis.",2020,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"['patients with psoriasis', '46 patients used the preparation at their homes before regular sunbathing', 'Ninety patients with plaque psoriasis were enrolled in the study, of whom 44 received', 'psoriatic patients', 'Psoriasis']","['narrow-band UVB (NB-UVB) phototherapy', 'ultraviolet B (UVB) phototherapy', 'Ultraviolet Phototherapy', 'UVB phototherapy', 'Medical Device Containing Sodium Hyaluronate and Nicotinic Acid']","['median L-PSI score', 'cosmetic acceptability', 'Local Psoriasis Severity Index (L-PSI), cosmetic acceptability and tolerability', 'L-PSI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038813', 'cui_str': 'Sunbathing'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",90.0,0.0219961,The application of UV Fotogel prior to sunbathing also led to a significant decrease in L-PSI score.,"[{'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bende', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Kui', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Annamária', 'Initials': 'A', 'LastName': 'Németh', 'Affiliation': 'Clinical Research Coordination Centre, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Borsos', 'Affiliation': 'Adware Research Ltd., Balatonfüred, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Tóbiás', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Erős', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. eros.gabor@med.u-szeged.hu.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Kemény', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Baltás', 'Affiliation': 'Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.'}]",Dermatology and therapy,['10.1007/s13555-020-00385-9']
46,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
47,32391555,Differences in Smoking Topography and Subjective Responses to Smoking Among African American and White Menthol and Non-Menthol Smokers.,"INTRODUCTION


It has been suggested that menthol increases exposure to harmful elements of smoking and makes smoking more rewarding, easier to initiate, and harder to quit. Isolating the direct effects of menthol is challenging as African American (AA) race and menthol preference are highly overlapping. This study evaluated smoking behavior and subjective responses among a balanced sample of AA and white menthol and non-menthol smokers. In addition, smoking topography (ST) was compared to naturalistic smoking (NS) and interactions with menthol and race were explored.
AIMS AND METHODS


Smokers (N = 100) smoked and rated their preferred brand of cigarettes via ST or NS during two laboratory visits (counterbalanced).
RESULTS


Controlling for baseline differences among the groups (eg, nicotine dependence), menthol smokers took shorter and smaller puffs and AA smokers took longer puffs, but there were no differences in total puff volume, carbon monoxide, or other ST parameters. Menthol smokers reported greater urge reduction and lower sensory stimulation. The smoking method (ST vs. NS) had no effects on smoking behavior or exposure. Cigarettes smoked via ST were rated stronger. Differences in satisfaction based on the smoking method interacted with race and menthol status. Ratings of aversion differed by race and menthol status.
CONCLUSIONS


Menthol was not associated with increased smoke exposure or reward (except for urge reduction). ST caused minimal experimental reactivity relative to NS. Additional research that isolates the effects of menthol and examines potential interactive effects with race and other variables is needed to better understand its role in smoking-related health disparities.
IMPLICATIONS


Menthol and non-menthol smokers differed on some demographic variables and menthol preference was associated with greater nicotine dependence and greater urge reduction after smoking. Menthol was not associated with greater smoke exposure. Future research that investigates the unique risks associated with menthol and examines potential interactive effects with race and other related variables is warranted to better understand the role of menthol in smoking-related health disparities.",2020,Smoking method (ST vs NS) had no effects on smoking behavior or exposure.,"['Smokers (N = 100) smoked and rated their preferred brand of cigarette via ST or NS during two laboratory visits (counterbalanced', 'balanced sample of AA and White menthol and non-menthol smokers', 'African American and White menthol and non-menthol smokers']","['ST', 'menthol']","['total puff volume, carbon monoxide, or other ST parameters', 'smoking behavior and subjective responses', 'urge reduction and lower sensory stimulation', 'smoking behavior or exposure', 'smoke exposure or reward']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",100.0,0.0108914,Smoking method (ST vs NS) had no effects on smoking behavior or exposure.,"[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Gunawan', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Juliano', 'Affiliation': 'Department of Psychology, American University, Washington, DC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa079']
48,32390092,"A randomized, controlled, two-month pilot trial of stannous fluoride dentifrice versus sodium fluoride dentifrice after oxalate treatment for dentinal hypersensitivity.","OBJECTIVES


To compare the effects of a stannous fluoride dentifrice and a sodium fluoride dentifrice on dentinal hypersensitivity when used with an oxalate-based regimen combining in-office and at-home treatment.
MATERIALS AND METHODS


In this single-center, randomized, controlled, double-blind, pilot clinical trial, 30 subjects were professionally treated at baseline with a 3% oxalate/potassium salt solution on up to two target teeth, then randomized 1:1 to either 0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice. Both groups were given 6 sensitivity strips (3.14% potassium oxalate gel) and a soft, manual toothbrush. Subjects were permitted to apply strips on up to two teeth, up to three times per tooth, at home as desired throughout the study. Dentinal sensitivity (cold air blast challenge) was assessed at baseline, immediately after post-professional treatment, and at day 60 using the Schiff scale and a Visual Analog Scale (VAS).
RESULTS


Immediately after professional oxalate treatment, the overall mean Schiff and VAS score decreased 25.6% and 22.4% from baseline, respectively (p ≤ 0.001 for both). At day 60, further reductions in both mean scores were seen in both groups. There were no significant differences between the groups at day 60. All treatments were well tolerated.
CONCLUSIONS


In subjects treated with oxalates for dentinal hypersensitivity, both stannous fluoride and sodium fluoride dentifrices are well tolerated, are feasible for routine use, and do not detract from the desensitizing effects of an in-office and at-home oxalate combination treatment regimen.
CLINICAL RELEVANCE


Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.",2020,There were no significant differences between the groups at day 60.,"['dentinal hypersensitivity patients who undergo professional oxalate treatment', 'dentinal hypersensitivity', '30 subjects were professionally treated at baseline with a 3']","['stannous fluoride dentifrice', 'stannous fluoride or sodium fluoride dentifrices', 'stannous fluoride dentifrice versus sodium fluoride dentifrice', '0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice', 'sodium fluoride dentifrice', 'stannous fluoride and sodium fluoride dentifrices', 'oxalate/potassium salt solution']","['Dentinal sensitivity (cold air blast challenge', 'tolerated', 'overall mean Schiff and VAS score', 'Visual Analog Scale (VAS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",30.0,0.0592205,There were no significant differences between the groups at day 60.,"[{'ForeName': 'Chad J', 'Initials': 'CJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy. chadjanderson@sbcglobal.net.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Kugel', 'Affiliation': 'Department of Comprehensive Care, School of Dental Medicine, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Yuanshu', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03275-8']
49,32393300,"The effect of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.","OBJECTIVE


The purpose of this study was to explore the effects of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.
METHODS


A retrospective study of 99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China. According to the different interventions, all the participants were divided into 3 groups: group A: music therapy; group B: rest without music therapy; and group C: conventional treatment. The Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to measure the patient's pain, anxiety and depression before and after 30 min of the intervention.
RESULTS


There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention. After 30 min of music therapy, the NRS, SDS and SAS scores of patients in group A were significantly lower than those before music therapy, and the differences were statistically significant. However, before and after the intervention in groups B and C, the NRS, SDS and SAS scores were not statistically significant. By comparison among the three groups after 30 min of intervention, the NRS, SDS and SAS scores in patients in group A were significantly lower than those in groups B and C, and the differences were statistically significant. The scores were not significantly different between groups B and C.
CONCLUSION


Music therapy can effectively alleviate the pain, anxiety and depression of patients after coronary artery bypass grafting.",2020,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","['99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China', 'patients after coronary artery bypass grafting']","['music therapy', 'music therapy; group B: rest without music therapy; and group C: conventional treatment', 'Music therapy']","[""patient's pain, anxiety and depression"", 'pain, anxiety and depression', 'Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS', 'NRS, SDS and SAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0155104,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","[{'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. caohua0791@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01141-y']
50,32330670,Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.,"BACKGROUND


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


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


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


Clinicaltrials.gov Identifier: NCT03663452.",2020,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"['military BH clinics relative to provider training in PE alone', 'military behavioral health clinics']",[],['PTSD symptoms'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0549177,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"[{'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Rosen', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: craig.rosen@va.gov.'}, {'ForeName': 'C Adrian', 'Initials': 'CA', 'LastName': 'Davis', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: carrie.davis6@va.gov.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riggs', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: driggs@deploymentpsych.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: jcook@deploymentpsych.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America; Department of Psychology, University of Texas at San Antonio, One UTSA Circle, San Antonio, TX 78249, United States of America. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, United States of America. Electronic address: kcomtois@uw.edu.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: keithhaddock@hopehri.com.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas at Austin, Steve Hicks School of Social Work, 1925 San Jacinto Blvd, Austin, TX 78712, United States of America. Electronic address: Elisa.Borah@austin.utexas.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Finley', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Department of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Veterans Evidence-based Research Dissemination and Implementation Center (VERDICT), South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America. Electronic address: finleye@uthscsa.edu.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Jahnke', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: sara@hopehri.com.'}, {'ForeName': 'Walker S C', 'Initials': 'WSC', 'LastName': 'Poston', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: carlosposton@hopehri.com.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: sws1@stanford.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neitzer', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: andrea.neitzer@va.gov.'}, {'ForeName': 'Capt Rachel', 'Initials': 'CR', 'LastName': 'Broussard', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: rachel.a.broussard2.mil@mail.mil.'}, {'ForeName': 'Maj Amy', 'Initials': 'MA', 'LastName': 'Brzuchalski', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: amy.e.brzuchalski.mil@mail.mil.'}, {'ForeName': 'Maj Spencer P', 'Initials': 'MSP', 'LastName': 'Clayton', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: spencer.p.clayton.mil@mail.mil.'}, {'ForeName': 'Lt Allison M', 'Initials': 'LAM', 'LastName': 'Conforte', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: allison.m.conforte.mil@mail.mil.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: araceli.flores8.civ@mail.mil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Blanchfield Army Community Hospital, Ft. Campbell, 650 Joel Dr, Fort Campbell, KY 42223, United States of America. Electronic address: jessica.l.hein.civ@mail.mil.'}, {'ForeName': 'Capt Felicia', 'Initials': 'CF', 'LastName': 'Keith', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: felicia.a.keith.mil@mail.mil.'}, {'ForeName': 'Capt Jeremy', 'Initials': 'CJ', 'LastName': 'Jinkerson', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: jeremy.d.jinkerson.mil@mail.mil.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Letendre', 'Affiliation': 'Bassett Army Community Hospital, Ft. Wainwright, 4076 Neely Rd, Fairbanks, AK 99703, United States of America. Electronic address: margaret.a.letendre.civ@mail.mil.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Nofziger', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: debra.l.nofziger.ctr@mail.mil.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Pollick', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: kirsten.m.pollick2.civ@mail.mil.'}, {'ForeName': 'Capt Kyra', 'Initials': 'CK', 'LastName': 'Santiago', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: kyra.t.santiago.mil@mail.mil.'}, {'ForeName': 'Lt Col John', 'Initials': 'LCJ', 'LastName': 'Waggoner', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: john.w.waggoner6.mil@mail.mil.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: craig.a.woodworth.civ@mail.mil.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: carmen.mclean4@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106008']
51,32394723,"Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.","Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm 3 . Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial ( n  = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a ""continuous use"" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm 3  and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log 10  copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm 3  (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm 3  slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.",2020,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","['women using DMPA-IM', 'women 16-35 years randomized to']","['DMPA-IM, copper IUD, or levonorgestrel implant', 'DMPA-IM, the copper IUD and levonorgestrel (LNG) implant', 'depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants']","['mean viral load and CD4 cell levels', 'time to viral suppression', 'VL relative to copper IUD', 'HIV viral load and CD4 cell count', 'early HIV disease progression', 'time to CD4 count <350 cells/mm3 and viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}]",382.0,0.424447,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, Department of Obstetrics and Gynaecology, University of Witwatersrand/Fort Hare/Walter Sisulu, East London, South Africa.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'Mailman School of Public Health, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), University of Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Emavundleni Research Center, Capetown, South Africa.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'KEMRI-RCTP Study Center, Kisumu, Kenya.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynecology, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Center, Soshanguve, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and human retroviruses,['10.1089/AID.2020.0015']
52,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
53,32379634,Effect of hand massage on pain and anxiety in patients after liver transplantation: A randomised controlled trial.,"OBJECTIVES


This study aimed to determine the effects of hand massage on postoperative pain, and anxiety levels in liver transplant patients.
METHODS


This study was a randomised clinical trial. The study sample comprised 80 adult patients who had liver transplantation: 40 experimental and 40 control group. In the experimental group, the researcher performed hand massage. No treatment was performed in the control group. To analyse the data, descriptive statistics, a chi-squared test, a t-test for dependent groups, and a t-test for independent groups were used.
RESULTS


According to hand massage follow-ups after liver transplantation, the mean scores of pain intensity and anxiety levels was lower, with a statistical significance in the experimental group compared with the control group in all measurements before and after hand massage (p < 0.001).
CONCLUSIONS


The hand massage applied to liver transplant patients positively affected and decreased the severity of pain, and anxiety levels.",2020,"The hand massage applied to liver transplant patients positively affected and decreased the severity of pain, and anxiety levels.","['80 adult patients who had liver transplantation: 40 experimental and 40 control group', 'patients after liver transplantation', 'liver transplant patients']",['hand massage'],"['mean scores of pain intensity and anxiety levels', 'postoperative pain, and anxiety levels', 'severity of pain, and anxiety levels', 'pain and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",80.0,0.0440946,"The hand massage applied to liver transplant patients positively affected and decreased the severity of pain, and anxiety levels.","[{'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Demir', 'Affiliation': 'Vocational School of Health Sciences, Selçuk University, Konya, Turkey. Electronic address: bilsevarac@gmail.com.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Saritas', 'Affiliation': 'Department of Surgical Nursing, Faculty of Nursing, Inonu University, Malatya, Turkey. Electronic address: serdar.saritas@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101152']
54,32379635,"The effect of lemon inhalation aromatherapy on blood pressure, electrocardiogram changes, and anxiety in acute myocardial infarction patients: A clinical, multi-centered, assessor-blinded trial design.","BACKGROUND


This study aimed to determine the effect of lemon (Limon Citrus) inhalation aromatherapy on Blood Pressure (BP), electrocardiogram changes, and anxiety in patients with Acute Myocardial Infarction (AMI).
METHODS


In this clinical trial, 100 AMI patients were assigned to intervention (received lemon inhalation aromatherapy) and control (received paraffin) groups. Aromatherapy was conducted for three consecutive days. BP, electrocardiogram changes, and anxiety were assessed.
RESULTS


A significant difference was observed between the two groups concerning systolic BP and percentage of ST-segment and T wave changes on the 3rd and 4th days after the intervention. A significant difference was also found between the two groups concerning heart rate and anxiety on the 4th day after the intervention.
CONCLUSION


As lemon inhalation aromatherapy in AMI reduced systolic BP, anxiety, and percentage of ST-segment and T wave changes and regulated heart rate, using this kind of aromatherapy is suggested in coronary care units.
CLINICAL TRIAL REGISTRY


The study was registered in the Iranian Registry of Clinical Trials (IRCT registration number: 33151, 2018/09/22).",2020,"A significant difference was also found between the two groups concerning heart rate and anxiety on the 4th day after the intervention.
","['acute myocardial infarction patients', 'patients with Acute Myocardial Infarction (AMI', '100 AMI patients']","['lemon (Limon Citrus) inhalation aromatherapy', 'lemon inhalation aromatherapy', 'Aromatherapy', 'intervention (received lemon inhalation aromatherapy) and control (received paraffin']","['Blood Pressure (BP), electrocardiogram changes, and anxiety', 'systolic BP and percentage of ST-segment and T wave changes', 'systolic BP, anxiety, and percentage of ST-segment and T wave changes and regulated heart rate', 'heart rate and anxiety', 'BP, electrocardiogram changes, and anxiety', 'blood pressure, electrocardiogram changes, and anxiety']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0440283', 'cui_str': 'Citrus limon'}, {'cui': 'C0008865', 'cui_str': 'Citrus'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",100.0,0.0671626,"A significant difference was also found between the two groups concerning heart rate and anxiety on the 4th day after the intervention.
","[{'ForeName': 'Masoume', 'Initials': 'M', 'LastName': 'Rambod', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rakhshan', 'Affiliation': 'Community Based Psychiatric Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: rakhshanm@sums.ac.ir.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tohidinik', 'Affiliation': 'Student Research Committee of Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Nikoo', 'Affiliation': 'Cardiovascular Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101155']
55,32278820,The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 3-Month and 12-Month Results of a Pilot Study.,"BACKGROUND


We previously reported inpatient and 30-day postoperative patient-reported outcomes (PROs) of a controlled, noncrossover pilot study using preoperative mindfulness-based stress reduction (MBSR) training for lumbar spine surgery. Our goal here was to assess 3-month and 12-month postoperative PROs of preoperative MBSR in lumbar spine surgery for degenerative disease.
METHODS


Intervention group participants were prospectively enrolled in a preoperative online MBSR course. A comparison standard care only group was one-to-one matched retrospectively by age, sex, surgery type, and prescription opioid use. Three-month and 12-month postoperative PROs for pain, disability, quality of life, and opioid use were compared within and between groups. Regression models were used to assess whether MBSR use predicted outcomes.
RESULTS


Twenty-four participants were included in each group. At 3 months, follow-up was 87.5% and 95.8% in the comparison and intervention groups, respectively. In the intervention group, mean Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) was significantly higher, whereas mean Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) and Oswestry Disability Index were significantly lower. The change from baseline in mean PROMIS-PF and PROMIS-PI was significantly greater than in the comparison group. At 12 months, follow-up was 58.3% and 83.3% in the comparison and intervention groups, respectively. In the intervention group, mean PROMIS-PI was significantly lower and change in mean PROMIS-PI from baseline was significantly greater. MBSR use was a significant predictor of change in PROMIS-PF at 3 months and in PROMIS-PI at 12 months. No adverse events were reported.
CONCLUSIONS


Three-month and 12-month results suggest that preoperative MBSR may have pain control benefits in lumbar spine surgery.",2020,MBSR use was a significant predictor of change in PROMIS-PF at 3 months and in PROMIS-PI at 12 months.,"['lumbar spine surgery for degenerative disease', 'lumbar spine surgery', 'Twenty-four participants were included in each group', 'Intervention group participants were prospectively enrolled in a preoperative online MBSR course', 'Lumbar Spine Degenerative Disease']","['preoperative mindfulness-based stress reduction (MBSR) training', 'Preoperative Mindfulness-Based Stress Reduction']","['mean Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF', 'postoperative PROs for pain, disability, quality of life, and opioid use', 'adverse events', 'mean PROMIS-PI', 'Outcomes Measurement Information System-Pain Interference (PROMIS-PI) and Oswestry Disability Index', 'mean PROMIS-PF and PROMIS-PI']","[{'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C1285162', 'cui_str': 'Degenerative disorder'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",24.0,0.0243929,MBSR use was a significant predictor of change in PROMIS-PF at 3 months and in PROMIS-PI at 12 months.,"[{'ForeName': 'Juneyoung L', 'Initials': 'JL', 'LastName': 'Chavez', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA. Electronic address: June.Yi@hsc.utah.edu.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Porucznik', 'Affiliation': 'Division of Public Health, Department of Family and Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Gren', 'Affiliation': 'Division of Public Health, Department of Family and Preventive Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Joyce', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Darrel S', 'Initials': 'DS', 'LastName': 'Brodke', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Dailey', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Mahan', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Hood', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Lawrence', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Spiker', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Spina', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Erica F', 'Initials': 'EF', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery, Clinical Neurosciences Center, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.186']
56,32393370,Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.,"INTRODUCTION


Pain management after coronary artery bypass graft (CABG) surgery remains challenging.
OBJECTIVE


This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief.
METHOD


This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery.
INTERVENTION


The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction.
STATISTICAL ANALYSIS


The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05.
RESULTS


Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables.
CONCLUSION


The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief.
TRIAL REGISTRY


IRCT20150216021098N5. Registered at 2019-09-12.",2020,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","['60 patients undergoing elective on-pump coronary artery bypass graft surgery', 'Ahvaz, Iran, from September 2018-December 2019', 'after coronary artery bypass graft surgery']","['Ketorolac and Paracetamol', 'coronary artery bypass graft (CABG) surgery', 'ketorolac mg/dl and 10\u2009mg/kg of Paracetamol', 'Paracetamol', 'ketorolac', 'ketorolac and Paracetamol']","['VAS score', 'statistical VAS score', 'demographic data, VAS scores, vital signs, and side effects', 'postoperative CABG pain relief', 'hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction', 'visual analog pain scale (VAS', 'postoperative pain relief', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",60.0,0.1372,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforooshzadeh', 'Affiliation': 'Department of Cardiac Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. f_javaherforoosh@yahoo.com.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Abdalbeygi', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farahzad', 'Initials': 'F', 'LastName': 'Janatmakan', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Gholizadeh', 'Affiliation': 'Atherosclerosis Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01125-y']
57,32392700,Evaluation of the Stomatognathic System before and after Osteopathic Manipulative Treatment in 120 Healthy People by Using Surface Electromyography.,"Objective:  To investigate the action of osteopathic manipulative treatment on the muscular activity of the stomatognathic apparatus by using surface electromyography (sEMG).  Material and Methods:  Surface electromyography (sEMG) was performed on the masseter and anterior temporalis muscles of 120 subjects (73 F; 47 M), both at time T0 and T2. The sample was divided into three randomized groups of 40 subjects each: control, placebo, and osteopathic manipulative treatment (OMT). In the T1 interval between the two evaluations, the control group was not treated, the placebo group underwent a placebo treatment, and the OMT group underwent manipulative treatment. The mean value of each measurement and its coefficient of variation, between time T0 and T2, were calculated for both the intragroup (OMT, placebo, control) and the intergroup (OMT-placebo, OMT-control).  Outcomes:  In 40% of the subjects, statistically significant improvements were highlighted in the OMT. Whereas, the statistically significant results of the placebo and control groups were 7.5% and 17.5%, respectively, of which more than 75% moved away from the physiological range, showing a worsening of the muscular activity. This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  Conclusions:  OMT determines variations of the activity of masticatory muscles.",2020,This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  ,"['120 Healthy People by Using Surface Electromyography', '40 subjects each']","['control, placebo, and osteopathic manipulative treatment (OMT', 'Surface electromyography (sEMG', 'OMT', 'osteopathic manipulative treatment', 'placebo']",['OMT'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]",[],120.0,0.05336,This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  ,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manzotti', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Viganoni', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Lauritano', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bernasconi', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Paparo', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Rachele', 'Initials': 'R', 'LastName': 'Risso', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nanussi', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17093250']
58,32396180,Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT02363712.",2020,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","['Swiss university hospital', 'Participants (N\u2009=\u2009220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017', '220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up', 'People With Knee Osteoarthritis', 'people with symptomatic knee osteoarthritis', 'participants with knee pain from osteoarthritis']","['Biomechanical Footwear', 'biomechanical footwear therapy', 'calibrated biomechanical footwear therapy', 'biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n\u2009=\u2009111) or to control footwear (n\u2009=\u2009109) that had visible outsole pods that were not adjustable and did not create a convex walking surface']","['pain and physical function', 'WOMAC physical function subscore', 'WOMAC stiffness subscore', 'Knee Pain', 'serious adverse events', 'pain', 'knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms', 'mean standardized WOMAC pain subscore', 'WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms', 'WOMAC global score']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",220.0,0.172357,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heldner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lenz', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Harald M', 'Initials': 'HM', 'LastName': 'Bonel', 'Affiliation': 'Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Hawker', 'Affiliation': 'Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.3565']
59,32398500,The Effect of Rehospitalization and Emergency Department Visits on Subsequent Adherence to Weight Telemonitoring.,"BACKGROUND


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


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


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


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


Experiencing a rehospitalization had the effect of diminishing adherence to daily weighing. Providers using telemonitoring to monitor decompensation and manage medications should take advantage of the potential ""teachable moment"" during hospitalization to reinforce the importance of adherence.",2020,The Better Effectiveness,['patients discharged to home after hospitalization for decompensated heart failure'],['remote telemonitoring intervention'],"['Better Effectiveness', 'rate for adherence']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0488464,The Better Effectiveness,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': 'Sarah C. Haynes, PhD, MPH Department of Pediatrics, University of California Davis, Sacramento, California. Daniel J. Tancredi, PhD Department of Pediatrics and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Kathleen Tong, MD Adventist Heart and Vascular Institute, St. Helena, California. Jeffrey S. Hoch, PhD Department of Public Health Sciences and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Michael K. Ong, MD, PhD Division of General Internal Medicine and Health Services Research, University of California Los Angeles and VA Greater Los Angeles Healthcare System, California. Theodore G. Ganiats, MD Department of Family Medicine and Public Health, University of California San Diego School of Medicine, La Jolla, California. Lorraine S. Evangelista, PhD, RN Sue and Bill Gross School of Nursing, University of California Irvine, California. Jeanne T. Black, PhD, MBA Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California. Andrew Auerbach, MD, MPH Department of Medicine, University of California San Francisco School of Medicine. Patrick S. Romano, MD, MPH Division of General Medicine and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': ''}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': ''}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': ''}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': ''}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': ''}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000689']
60,31829664,Live counselor contact in a Facebook intervention predicts smoking cessation outcomes.,"Digital smoking cessation interventions frequently use automated delivery of content. Integrating a counselor may improve participant engagement and facilitate health behavior change. We investigated engagement with live counseling compared to automated content in a Facebook intervention and the impact of engagement on smoking cessation outcomes. The Tobacco Status Project is a 90-day smoking cessation intervention for young adults utilizing automated posts and weekly sessions with a live counselor in Facebook groups tailored to readiness to quit (precontemplation, contemplation, preparation). Data came from the treatment group of a randomized trial. Post-level analyses investigated participant engagement (number of comments) by post type (e.g., counselor posts or automated posts based on transtheoretical model of behavior change, clinical practice guidelines, motivational interviewing), stratified by readiness to quit. Participant-level analyses examined whether extent of participant engagement with counselor posts predicted abstinence at 3 months. We analyzed data of  N  = 251 participants and  N  = 2,941 posts, 11% of which were live counselor initiated, and together generated 8,403 comments. Post-level analyses found that compared to the most engaging automated content (motivational content for precontemplation and contemplation, informational content for preparation), live counseling generated more engagement among participants in preparation, similar engagement in precontemplation, and less engagement in contemplation. Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]). In digital interventions, counselor contact may be beneficial in addition to automated posts at yielding engagement and abstinence; however, participants engage differently with counseling according to readiness to quit. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]).","['N  = 251 participants and  N  = 2,941 posts, 11% of which were live counselor initiated, and together generated 8,403 comments']","['Digital smoking cessation interventions', 'Facebook intervention', 'live counseling']",[],"[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],,0.0515934,"Extent of live counseling participation predicted 3-month verified abstinence (adjusted  OR  = 1.10, 95% CI [1.02, 1.20]).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Tice', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Oona', 'Initials': 'O', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000541']
61,32304828,"IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods.","BACKGROUND


African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS.
METHODS


This is a mixed-methods study that includes a randomized-controlled trial, ""IMPROVE"", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
DISCUSSION


Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.",2020,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","['older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds', '220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged', 'African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS', 'Participants are ≥65\u202fyears old and within five years of treatment completion for stage I-III breast cancer']","['moderate intensity aerobic and resistance group exercise intervention', 'exercise intervention', 'community-based exercise intervention']","['functional and health outcomes', 'change in Short Physical Performance Battery (SPPB) Scores', 'change in SPPB scores at 52\u202fweeks, change in body composition and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",220.0,0.0741916,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Owusu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: Cynthia.owusu@case.edu.'}, {'ForeName': 'Nora L', 'Initials': 'NL', 'LastName': 'Nock', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hergenroeder', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, MetroHealth Medical Center, Cleveland, OH, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennet', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cerne', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Department of Hematology/Oncology, Cleveland, OH, United States of America.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Petkac', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, OH, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schluchter', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Penn State University College of Medicine, Hershey, PA, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb Hooper', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'California Baptist University, Riverside, CA, United States of America.'}, {'ForeName': 'Oghenerukeme', 'Initials': 'O', 'LastName': 'Asagba', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV, United States of America.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Wimbley', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Berger', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106001']
62,32200304,Effects of sleep restriction on subjective and physiological variables in middle-aged Korean adults: an intervention study.,"BACKGROUND


Adequate sleep is crucial for normal functioning. However, most people, including middle-aged adults of reproductive age, show a marked reduction in their sleep duration. Thus, sleep is a major issue that should be addressed in health management. We investigated the effects of short-term sleep restriction on subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP]) in middle-aged adults, the recovery of these parameters after rest, and the associations between parameters.
METHODS


A total of 118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled. Participants underwent a 4-h sleep restriction per day for 3 day at a hospital, and then returned to their daily lives to take four days of rest. A questionnaire and blood test were administered before and after sleep restriction, and after the recovery period, to assess subjective and physiological parameters.
RESULTS


After sleep restriction, sleepiness, fatigue, and stress significantly increased compared to baseline. Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline. After the recovery phase, all parameters were restored to levels similar to baseline levels. Changes in each parameter were mutually associated; fatigue and sleepiness had the strongest association.
CONCLUSION


Our results suggest that even a short period of sleep restriction can have an adverse impact on psychological and physiological stress parameters in middle-aged adults, and that adequate rest and sleep are needed to restore them to normal levels.",2020,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","['118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled', 'middle-aged Korean adults', 'middle-aged adults']","['sleep restriction', 'short-term sleep restriction']","['sleepiness, fatigue, and stress', 'Cortisol and TSH', 'subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP', 'subjective and physiological variables', 'fatigue and sleepiness']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",118.0,0.0305566,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","[{'ForeName': 'Younghwa', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Kyungsik', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Siwoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: ifree72@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.006']
63,32289471,Improving health engagement and lifestyle management for breast cancer survivors with diabetes.,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-management strategies. This study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management behaviors. The telephone-based DCST protocol integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. A randomized clinical trial will test the DCST intervention plus diabetes education by comparing it to diabetes education alone. Symptoms, distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. This study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. Special considerations for this medically underserved population are also provided. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors. Trials registration: ClinicalTrials.gov, NCT02970344, registered 11/22/2016.",2020,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","['Many breast cancer survivors with type 2 diabetes', 'breast cancer survivors with type 2 diabetes', 'breast cancer survivors with diabetes', 'breast cancer survivors', 'Breast cancer survivors with type 2 diabetes']","['healthy lifestyle skills training', 'novel diabetes coping skills training (DCST) intervention', 'telephone-based DCST protocol integrates three key theory-based strategies: coping skills training', 'novel behavioral intervention', 'DCST intervention plus diabetes education']","['Symptoms, distress, diabetes self-management behaviors, and self-efficacy', 'Glycosylated hemoglobin (HbA1c']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0336858,"Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes.","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: rebecca.shelby@duke.edu.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Dorfman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Arthur', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America; Division of General Internal Medicine, Duke University, Durham, NC, United States of America; Department of Population Health Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Corsino', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sutton', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'Duke Cancer Network, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Erkanli', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Corbett', 'Affiliation': 'Supportive Care and Survivorship Center, Duke Cancer Institute, Durham, NC, United States of America.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Kimmick', 'Affiliation': 'Division of Medical Oncology, Duke University Medical Center, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105998']
64,32193052,Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial.,"OBJECTIVE


Obstructive sleep apnea (OSA) is a high prevalent disorder with severe consequences including sleepiness, metabolic, and cardiovascular disorders. The aim of this study was to assess the effect of an individualized exercise-training (IET) program with educational sessions vs educational sessions alone on severity markers of OSA over an eight-week duration.
METHODS


This was a randomised, controlled, parallel-design study. In sum, 64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40 kg/m 2  were included in intervention group (IG) or control group (CG), and 54 patients finished the study. All underwent polysomnography (PSG), multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice. The primary endpoint was the change in apnea-hypopnea (AHI) at eight weeks from baseline. Main secondary endpoints were daytime sleepiness assessed by questionnaire and objective tests.
RESULTS


No significant between-group differences were found for changes in AHI. A reduction in AHI was found in IG only (p = 0.005). Compared to CG, exercise training leads to a greater decrease in AHI during REM sleep (p = 0.0004), with a significant increase in mean daytime sleep latency (p = 0.02). Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
CONCLUSIONS


In adult patients with moderate-to-severe OSA, IET did not decrease AHI compared to the control group but improved markers of severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness. Adding personalized exercise training to the management of patients with OSA should be considered. CLINICALTRIALS.
GOV IDENTIFIER


NCT01256307.",2020,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
","['64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40\xa0kg/m 2  were included in intervention group (IG) or control group (CG), and 54 patients finished the study', 'obstructive sleep apnea syndrome', 'patients with OSA', 'Obstructive sleep apnea (OSA']","['individualized exercise-training (IET) program with educational sessions vs educational sessions alone', 'individualized exercise training program', 'personalized exercise training']","['severity markers of OSA', 'AHI', 'weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms', 'AHI during REM sleep', 'multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice', 'mean daytime sleep latency', 'change in apnea-hypopnea (AHI', 'daytime sleepiness assessed by questionnaire and objective tests', 'severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness', 'changes in AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1521798', 'cui_str': 'With trend (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0519186', 'cui_str': 'Multiple sleep latency test (procedure)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",64.0,0.01711,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bughin', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Desplan', 'Affiliation': 'Specialized Medical Center Medimarien, Marcel Marien Street 21, 1030, Brussels, Belgium; LaboCenter for the Study of Sleep Disorders, Neuroscience Pole, DELTA Hospital, CHIREC, Boulevard of the Triumph 201, 1160, Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mestejanot', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Clinical Research and Epidemiology Unit, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jaffuel', 'Affiliation': 'Department of Pneumology, Arnaud de Villeneuve, Regional University Hospital of Montpellier, 371 Avenue du Doyen Giraud, 34295, Montpellier Cedex 5, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jaussent', 'Affiliation': 'INSERM, U1061, Neuropsychiatry, Montpellier, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France; INSERM, U1061, Neuropsychiatry, Montpellier, France; University Montpellier, Montpellier, France. Electronic address: ydauvilliers@yahoo.fr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.008']
65,32399130,A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints.,"Objective


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


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


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


(1) Acupuncture is an effective method for the treatment of gastroparesis. (2) The combination of Zhongwan (CV 12) with Zusanli (ST 36) showed the most promising effect on relief of the symptoms in patients with gastroparesis. (3) ""Selecting acupoints by site"" is the key factor affecting the synergy effect of ""acupoint compatibility."" This trial was registered with the International Center for Clinical Trials (registration no. NCT02594397).",2020,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"['99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers', 'patients with gastroparesis']","['acupuncture', 'Acupuncture']","['gastric emptying rate', 'GCSI scores', 'score of each symptom', 'health status', 'main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",99.0,0.0357108,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xuefen', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xiaoli', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}]",Pain research & management,['10.1155/2020/8751958']
66,32396409,"A Prospective Randomized Controlled Trial of Irrigation ""Bag Squeeze"" to Manage Pain for Patients Undergoing Flexible Cystoscopy.","PURPOSE


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


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


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


This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.",2020,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","['Ten participants were ineligible because they required secondary procedures', 'Two hundred patients', 'Patients Undergoing Flexible Cystoscopy', '200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures', '190 eligible patients, 97 were randomized to', 'men', 'Men with prior urethral stricture or bladder neck contracture']","['bag-squeeze', 'flexible cystoscopy', 'Irrigation ""Bag Squeeze', 'bag-squeeze"" technique', 'cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure', 'irrigation bag during a flexible cystoscopy']","['mean pain score', 'pain questionnaire: visual analogue scale', 'pain perception', 'pain']","[{'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",200.0,0.261447,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","[{'ForeName': 'Mohamad Baker', 'Initials': 'MB', 'LastName': 'Berajoui', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ishan', 'Initials': 'I', 'LastName': 'Aditya', 'Affiliation': 'University of Toronto, School of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'JaimeOmar', 'Initials': 'J', 'LastName': 'Herrera-Caceres', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Qaoud', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lajkosz', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ajib', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Glase', 'Affiliation': 'Department of Neurosciences, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hersey', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Kenk', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hamilton', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Zlotta', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Perlis', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001139']
67,32320843,"Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial.","BACKGROUND


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


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


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


ClinicalTrials.gov, number NCT03671707.",2020,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","['1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking', 'smoking expectant fathers', 'antenatal clinic in seven public hospitals in Hong Kong, China', 'expectant fathers']","['nicotine replacement therapy sampling and active referral (BANSAR', 'brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care']","['carbon monoxide-verified (<4 part per million) abstinence', 'self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers']","[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.144204,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","[{'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Ju', 'Initials': 'CJ', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Cheong', 'Initials': 'WC', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Kwong Wah Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Yin', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Kwa', 'Affiliation': 'Department of Obstetrics & Gynecology, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Kar-Hung', 'Initials': 'KH', 'LastName': 'Siong', 'Affiliation': 'Department of Obstetrics & Gynecology, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Keung', 'Initials': 'KK', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics & Gynecology, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Kai-Wan', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Princess Margaret Hospital, Hong Kong.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong. Electronic address: mpwang@hku.hk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106006']
68,32194252,Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design.,"Care management approaches are being widely tested in the Medicare-eligible population to manage chronic conditions, but few have focused on cognitive vulnerability as the pathway to optimizing independence in the community-dwelling older population. Cognitive vulnerability refers to living with dementia, depression, and/or a history of delirium. Many studies have shown that cognitive vulnerability is associated with poor health-related outcomes in community-dwelling older adults, raising the health policy importance of finding evidence-based approaches to improve outcomes for this target population. Moreover, very little is known about effects of care management approaches in the rapidly growing Medicare Advantage population. In response to these knowledge gaps, we are testing the efficacy of an in-home, nurse practitioner-led care management team for adults age ≥ 65 with cognitive vulnerability in a Medicare Advantage population. Older adults and family caregivers randomized either to this multidisciplinary care management team, or to a telephonic care management program routinely offered by our Medicare Advantage partner. The intervention period is 12 months and the primary outcome is any emergency department visit or hospitalization over the 12-month period. In this paper, we report on the rationale for testing a multidisciplinary care management intervention for this target population, and explain how a university-based research team collaborated with a Medicare Advantage insurer to conceptualize and implement the clinical trial. We also provide details on study design, and on components of the in-home and telephonic care management interventions. We conclude with a synopsis of recruitment progress along with selected baseline characteristics of the study cohort.",2020,"Older adults and family caregivers randomized either to this multidisciplinary care management team, or to a telephonic care management program routinely offered by our Medicare Advantage partner.","['adults age\u202f≥\u202f65 with cognitive vulnerability in a Medicare Advantage population', 'older adults with cognitive vulnerability', 'Older adults and family caregivers', 'community-dwelling older adults']","['multidisciplinary care management intervention', 'multidisciplinary care management team, or to a telephonic care management program']",['emergency department visit or hospitalization'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2713369', 'cui_str': 'Medicare Advantage'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0465307,"Older adults and family caregivers randomized either to this multidisciplinary care management team, or to a telephonic care management program routinely offered by our Medicare Advantage partner.","[{'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Fortinsky', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-5215, USA. Electronic address: fortinsky@uchc.edu.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kuchel', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-5215, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Steffens', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-1410, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grady', 'Affiliation': 'Department of Public Health Sciences, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-6325, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, 69 North Eagleville Road, Storrs, CT 06269-3092, USA.'}, {'ForeName': 'Julie T', 'Initials': 'JT', 'LastName': 'Robison', 'Affiliation': 'UConn Center on Aging, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-5215, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105992']
69,32220632,"The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States.","Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.",2020,"Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11.","['Participants (n\u202f=\u202f550', 'South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans', 'South Asian adults at increased risk for ASCVD', 'South Asians in the United States', 'adults', 'South Asian adults', 'The South Asian Healthy Lifestyle Intervention (SAHELI) trial']","['community-based, culturally-adapted lifestyle intervention', 'printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program', 'evidence-based lifestyle interventions', 'Intensive lifestyle interventions targeting diet and physical activity']","['atherosclerotic cardiovascular disease (ASCVD) risk', 'cardiovascular risk', 'clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes']","[{'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0422793', 'cui_str': 'Other Asian (NMO) (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",550.0,0.0384926,"Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11.","[{'ForeName': 'Namratha R', 'Initials': 'NR', 'LastName': 'Kandula', 'Affiliation': 'Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States; Feinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States. Electronic address: n-kandula@northwestern.edu.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Bernard', 'Affiliation': 'Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States. Electronic address: VeronicaBernard2020@u.northwestern.edu.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Dave', 'Affiliation': 'Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States. Electronic address: swapna-dave@northwestern.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ehrlich-Jones', 'Affiliation': 'Feinberg School of Medicine, Department of Physical Medicine & Rehabilitation, Northwestern University, Chicago, IL, United States; Shirley Ryan AbilityLab, Chicago, IL, United States. Electronic address: ljones1@sralab.org.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Counard', 'Affiliation': 'Skokie Health Department, Skokie, IL, United States. Electronic address: Catherine.Counard@skokie.org.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Northshore University HealthSystem, Skokie Hospital, Skokie, IL, United States. Electronic address: NShah2@northshore.org.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Metropolitan Asian Family Services, Chicago, IL, United States. Electronic address: santoshk@umasinc.com.'}, {'ForeName': 'Goutham', 'Initials': 'G', 'LastName': 'Rao', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States. Electronic address: goutham.rao2@case.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ackermann', 'Affiliation': 'Feinberg School of Medicine, Division of General Internal Medicine, Northwestern University, Chicago, IL, United States. Electronic address: r.ackermann@northwestern.edu.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Feinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States. Electronic address: bspring@northwestern.edu.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Feinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States. Electronic address: siddique@northwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105995']
70,32220745,The effect of green walking on heart rate variability: A pilot crossover study.,"We investigated the effects of regular walking in green and suburban environments on heart rate variability (HRV) and blood pressure (BP) in middle-aged adults. Twenty-three adults participated in a non-randomized crossover experiment comprised of once-weekly 50-min moderate-intensity walking sessions. Separated by a two-week washout period, participants walked for three weeks in each of two treatment conditions (green and suburban) in a local arboretum and suburban sidewalks of Chaska, MN. Eleven participants completed green walking first and 12 suburban walking first. Walks were split into 15-min intra-walk phases, with phases representing each walk's beginning, middle, and final 15-min. Repeated measures linear mixed models evaluated (1) HRV phase differences between treatments and HRV change within treatments, and (2) pre- and post-walk BP differences between treatments and pre-to post-walk BP changes. Intra-walk phase analyses revealed higher HRV during green walking vs. suburban walking during phase 2 (p < 0.0001) and phase 3 (p = 0.02). Less HRV reduction was seen between intra-walk phases 1 and 2 during green vs. suburban walking (p = 0.02). Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP. Post-walk BP results were similar after both green walking and suburban walking. In summary, walking sessions in a green environment elicited greater beneficial HRV responses compared to a suburban environment. Additionally, walking in either environment, green or suburban, promoted reductions in systolic BP.",2020,"Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP.","['middle-aged adults', 'Eleven participants completed green walking first and 12 suburban walking first', 'Twenty-three adults participated']","['once-weekly 50-min moderate-intensity walking sessions', 'green walking', 'regular walking in green and suburban environments']","['mean systolic BP', 'systolic BP', 'beneficial HRV responses', 'HRV change within treatments, and (2) pre- and post-walk BP differences', 'HRV reduction', 'heart rate variability', 'heart rate variability (HRV) and blood pressure (BP', 'diastolic BP']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",23.0,0.0282478,"Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP.","[{'ForeName': 'Junia N', 'Initials': 'JN', 'LastName': 'de Brito', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: nogue013@umn.edu.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Pope', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: popex157@umn.edu.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Mitchell', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: mitc0186@umn.edu.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Schneider', 'Affiliation': 'Department of Forest Resources, University of Minnesota, 1530 Cleveland Ave North, Suite 301b, St. Paul, MN, 55108, USA. Electronic address: ingridss@umn.edu.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Larson', 'Affiliation': 'Minnesota Landscape Arboretum, Bakken Center for Spirituality & Healing, University of Minnesota, 3675 Arboretum Drive, Chaska, MN, 55318, USA. Electronic address: larso095@umn.edu.'}, {'ForeName': 'Teresa H', 'Initials': 'TH', 'LastName': 'Horton', 'Affiliation': 'Department of Anthropology, Northwestern University, 1819 Hinman Avenue, Evanston, IL, 60208, USA. Electronic address: thorton@northwestern.edu.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pereira', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: perei004@umn.edu.'}]",Environmental research,['10.1016/j.envres.2020.109408']
71,32270483,Long-term survival and cognitive function according to blood pressure management during cardiac surgery. A follow-up.,"BACKGROUND


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


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


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


No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year follow-up.",2020,No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year-follow-up.,"['197 patients who participated in the original study', 'cardiac surgery patients to either a low-target mean arterial pressure (40-50 mmHg) or a high-targetpressure (70-80 mmHg']",[],"['survival and level of cognitive functioning', 'POCD', 'Blood Pressure Management', 'mortality', 'blood pressure target', 'subjective functioning', '30-day mortality', 'Subjective level of functioning', 'POCD and subjective functioning', 'volume of new ischemic cerebral lesions nor POCD', 'Long-term Survival and Cognitive Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",197.0,0.217265,No difference in mortality nor in the level of cognitive functioning was found according to blood pressure target during cardiac surgery long-term at 3-year-follow-up.,"[{'ForeName': 'Mo H', 'Initials': 'MH', 'LastName': 'Larsen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Draegert', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Vedel', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Holmgaard', 'Affiliation': 'Department of Cardiothoracic Anaesthesia, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Anaesthesia, Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13595']
72,32271521,Influence of stereopsis on the ability to perform simulated microsurgery.,"PURPOSE


To determine whether impaired or absent stereopsis affects the ability to perform simulated microsurgical tasks.
SETTING


University of Edinburgh, United Kingdom.
DESIGN


Prospective randomized cross-over study.
METHODS


Visual acuity and stereoacuity were measured. A band-pass filter was placed over the nondominant eye to reduce stereoacuity to 150 seconds of an arc (partial stereopsis), or the nondominant eye was completely occluded (absent stereopsis). Participants completed a computerized surgical simulator task 3 times with a randomized testing order (normal stereopsis, absent stereopsis, and partial stereopsis). The task involved using forceps to grasp and position objects in the anterior chamber. Outcomes included area of ocular injury, time to task completion, and overall score.
RESULTS


Ocular damage area was significantly worse with partial stereopsis (P = .002) and worse still when stereopsis was absent (P < .001 for normal vs absent stereopsis and P = .005 for partial vs absent stereopsis). The median ocular damage area was 3.55 mm (interquartile range [IQR], 1.21-5.88 mm) with normal stereopsis, increasing to 6.10 mm (IQR, 3.96-12.47 mm) with stereopsis reduced to 150 seconds of an arc and to 9.25 mm (IQR, 4.93-18.70 mm) with no stereopsis. Time taken to complete the task increased and overall score decreased as stereopsis was reduced. The overall score decreased from 53% (IQR, 22.5-82%) under normal stereopsis to 0% (IQR, 0-43.5%) with absent stereopsis.
CONCLUSIONS


Impaired stereopsis was associated with worse microsurgical performance, which may have implications for surgical training. The absence of stereopsis resulted in worse performance than partial reduction in stereopsis.",2020,"RESULTS


Ocular damage area was significantly worse with partial stereopsis (P = .002) and worse still when stereopsis was absent (P <","['University of Edinburgh, United Kingdom']","['computerized surgical simulator task 3 times with a randomized testing order (normal stereopsis, absent stereopsis, and partial stereopsis']","['overall score', 'median ocular damage area', 'area of ocular injury, time to task completion, and overall score']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015408', 'cui_str': 'Eye injury'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.098261,"RESULTS


Ocular damage area was significantly worse with partial stereopsis (P = .002) and worse still when stereopsis was absent (P <","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dutton', 'Affiliation': 'From the Department of Ophthalmology, Princess Alexandra Eye Pavilion, University of Edinburgh (Dutton, Watkins, Henderson, Durgess, Tint, Dhillon, Tatham), and School of Medicine, University of St. Andrews (Durgess), North Haugh, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': ''}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'Naing L', 'Initials': 'NL', 'LastName': 'Tint', 'Affiliation': ''}, {'ForeName': 'Baljean', 'Initials': 'B', 'LastName': 'Dhillon', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Tatham', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000090']
73,32305456,Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.,"Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.",2020,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","['perinatal women seeking mental health treatment', 'women who seek mental health treatment, mental health clinics', 'perinatal women', 'women and their developing fetus/infant']","['Intimate partner victimization (IPV', 'Computerized intervention']",['adverse physical and emotional outcomes'],"[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",186.0,0.0511695,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Akron, Akron, OH 44325-4301, USA. Electronic address: johnsod@uakron.edu.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, MD, USA; School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, Obstetrics & Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ""Division of Research, Women and Infant's Hospital, Providence, RI, USA.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ""Department of Medicine, Women and Infant's Hospital, Providence, RI, USA; Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106011']
74,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


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


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


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
75,32334141,Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma.,"BACKGROUND


Blood eosinophil count (BEC) measurements are a noninvasive, relatively reliable surrogate marker for eosinophilic airway inflammation. Single measurements of peripheral BEC greater than or equal to 150 cells/μL predict the response to anti-eosinophil therapies for patients with characteristics of severe eosinophilic asthma.
OBJECTIVE


To describe how BECs shift over time for patients with severe, uncontrolled asthma receiving placebo in 2 large, randomized, placebo-controlled clinical trials of benralizumab (SIROCCO and CALIMA).
METHODS


Our analysis included all adult patients who were randomized to placebo in the SIROCCO and CALIMA phase III benralizumab studies. Patients were categorized into baseline BEC groups of less than 150 cells/μL, greater than or equal to 150 cells/μL but less than 300 cells/μL, and greater than or equal to 300 cells/μL. The timing of the initial shift from baseline to a different group was evaluated at weeks 4, 8, 24, and 40 and at the end of treatment. Baseline characteristics, including oral corticosteroid use, were described based on the presence or absence of a BEC group shift.
RESULTS


Of the 734 evaluable patients, 65% (n = 474) shifted BEC groups during the study, and most patients (86% [n = 410]) shifted by week 24. Patients who started in the less than 150 cells/μL group tended to shift groups earlier, with 59% shifting by week 4 compared with 38% to 55% for other groups in the same time frame. Patients who shifted BEC groups vs those who did not tend to have lower BECs, more oral corticosteroid use, and less incidence of nasal polyps or past polypectomy.
CONCLUSION


A single BEC measurement, particularly when low, may be inadequate to help establish a phenotype of severe eosinophilic asthma.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT01928771 (SIROCCO trial) and NCT01914757 (CALIMA trial).",2020,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","['patients with severe, uncontrolled asthma receiving', 'patients with characteristics of severe eosinophilic asthma', '734 evaluable patients, 65% (n=474) shifted blood eosinophil count groups during the study, and the majority (86% [n=410]) shifted by Week 24']",['placebo'],"['incidence of nasal polyps/past polypectomy', 'blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",734.0,0.0497634,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","[{'ForeName': 'Njira L', 'Initials': 'NL', 'LastName': 'Lugogo', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: nlugogo@med.umich.edu.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Kreindler', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Trudo', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.011']
76,32335056,Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,"PURPOSE


To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years.
DESIGN


Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison.
METHODS


Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
PATIENT POPULATION


Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye.
OBSERVATION PROCEDURES


Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA).
MAIN OUTCOME MEASURE


PCO score (scale, 0-10).
RESULTS


The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P = .23).
CONCLUSION


The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.",2020,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,[' Eighty patients (160 eyes) had bilateral cataract surgery and received a'],"['posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between two similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs', 'Vivinex XY1 IOL in one eye and an Acrysof SN60WF IOL in the other eye', 'hydrophobic acrylic intraocular lenses', 'neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy']","['PCO rates and lower YAG rates', 'mean objective PCO score', 'Posterior capsule opacification score (scale, 0-10']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.147149,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.011']
77,32305727,A polymorphism within the R-spondin 2 gene predicts outcome in metastatic colorectal cancer patients treated with FOLFIRI/bevacizumab: data from FIRE-3 and TRIBE trials.,"BACKGROUND


Through enhancement of the Wnt signalling pathway, R-spondins are oncogenic drivers in colorectal cancer. Experimental data suggest that the R-spondin/Wnt axis stimulates vascular endothelial growth factor (VEGF)-dependent angiogenesis. We therefore hypothesise that variations within R-spondin genes predict outcome in patients with metastatic colorectal cancer (mCRC) treated with upfront FOLFIRI and bevacizumab.
PATIENTS AND METHODS


773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group) were involved in this study. The impact of six functional single-nucleotide polymorphisms (SNPs) within the R-spondin 1-3 genes on outcome was evaluated.
RESULTS


RAS and KRAS wild-type patients harbouring any G allele of the RSPO2 rs555008 SNP had a longer overall survival compared with those having a TT genotype in both the training (FIRE-3) and validation (TRIBE) cohorts (29.0 vs 23.6 months, P = 0.009 and 37.8 vs 19.4 months, P = 0.021 for RAS wild-type patients and 28.4 vs 22.3 months, P = 0.011 and 36.0 vs 23.3 months, P = 0.046 for KRAS wild-type patients). Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
CONCLUSION


Genotyping of the RSPO2 rs555008 polymorphism may help to select patients who will derive the most benefit from FOLFIRI/bevacizumab dependent on (K)RAS mutational status.",2020,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","['patients with metastatic colorectal cancer (mCRC) treated with', '773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either', 'metastatic colorectal cancer patients treated with']","['FOLFIRI/bevacizumab', 'bevacizumab', 'upfront FOLFIRI and bevacizumab', 'six functional single-nucleotide polymorphisms (SNPs', 'FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group']","['overall survival', 'shorter progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",773.0,0.0944452,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: martin.berger@insel.ch.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Hematology, Oncology, and Tumor Immunology (Campus Charité Mitte), Charité Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Hanna', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Puccini', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ryuma', 'Initials': 'R', 'LastName': 'Tokunaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Battaglin', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.048']
78,31899372,Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial.,"COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589. CLINICAL TRIAL REGISTRATION: University of Illinois at Chicago Protocol Record 2017-1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17-074-E. NCT03397589.",2020,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","['National Institutes of Dental & Craniofacial Research of the National Institutes of Health', 'low-income, urban children under the age of three years', '420 child/caregiver dyads enrolled at the 20 participating sites over 11\u202fmonths', 'participant homes', 'University of Illinois at Chicago Protocol Record 2017-1090', 'Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois']","['COordinated Oral health Promotion (CO-OP', 'oral health community health worker (CHW) intervention', 'CHW intervention or usual services (a wait-list control']","['caregiver-reported child brushing frequency and observed plaque score', 'brushing frequency, plaque, and other oral health behaviors', 'oral health behaviors']","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0035168'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}]","[{'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion (regime/therapy)'}, {'cui': 'C0029162'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0029162'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.126316,"Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting.","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Martin', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States. Electronic address: mollyma@uic.edu.'}, {'ForeName': 'Lacey J', 'Initials': 'LJ', 'LastName': 'Zimmerman', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States.'}, {'ForeName': 'Genesis F', 'Initials': 'GF', 'LastName': 'Rosales', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Helen H', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'University of Illinois at Chicago, College of Medicine, 1853 W Polk St, Chicago, IL 60612, United States; University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Nattanit', 'Initials': 'N', 'LastName': 'Songthangtham', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Pugach', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Sandoval', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Avenetti', 'Affiliation': 'University of Illinois at Chicago, College of Dentistry, 801 S Paulina St, Chicago, IL 60612, United States.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Alvarez', 'Affiliation': 'University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W Roosevelt Road, Chicago, IL 60608, United States.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Gansky', 'Affiliation': 'University of California, Box# 1361, San Francisco, CA 94143, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105919']
79,32396914,The Effect of Lavender Oil on Sleep Quality and Vital Signs in Palliative Care: A Randomized Clinical Trial.,"BACKGROUND


This study was conducted to determine the effect of lavender oil on sleep quality and vital signs in palliative care patients.
METHODS


We examined 68 patients in a palliative care unit. Vital signs of all the patients were assessed, and also their sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire. Lavender was applied to patients in the experimental group. During the intervention, vital signs of the patients were monitored at 4-h intervals throughout the night, and sleep quality was evaluated during the morning. The same evaluation processes were performed for the control group.
RESULTS


It was observed in the evaluation that lavender application did not affect the vital signs of the patients but it ensured a deeper sleep on the 2nd day after the intervention, facilitated their falling asleep and sleeping again when they were awakened and enhanced sleep quality (p < 0.05). Also, this application decreased the awakening frequency on the 1st and 2nd days and enhanced overall sleep quality (p < 0.05) after the intervention.
CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.",2020,"CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.","['Palliative Care', '68 patients in a palliative care unit', 'palliative care patients']","['Lavender Oil', 'lavender oil', 'Lavender']","['awakening frequency', 'overall sleep quality', 'sleep quality and vital signs', 'Sleep Quality and Vital Signs', 'sleep quality']","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",68.0,0.0296234,"CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Nursing, University Faculty of Health Sciences, İstanbul Sabahattin Zaim University, Istanbul, Turkey, d.atici1987@hotmail.com.'}, {'ForeName': 'Vildan', 'Initials': 'V', 'LastName': 'Kocatepe', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey.'}, {'ForeName': 'Gülbeyaz', 'Initials': 'G', 'LastName': 'Can', 'Affiliation': 'Department of Internal Medicine Nursing, Faculty of Florence Nightingale Nursing, Istanbul University - Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Sulu', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Akış', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Güleser', 'Initials': 'G', 'LastName': 'Şahin', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Aktay', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Complementary medicine research,['10.1159/000507319']
80,32335288,The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers.,"BACKGROUND


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


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


Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.",2020,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","['engage lower-motivated smokers', 'smokers not ready to quit']","['Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge', 'Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages']","['number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3853073', 'cui_str': 'Smoking assessment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0313065,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America. Electronic address: daniel.amante@umassmed.edu.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, United States Department of Veterans Affairs, Ann Arbor, MI, United States of America; Systems, Populations and Leadership Department, School of Nursing, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Morley', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Conigliaro', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Mattocks', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; VA Central Western Massachusetts Healthcare System, Leeds, MA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States of America.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106002']
81,32276179,Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study.,"PURPOSE


Second-line chemotherapy regimens have demonstrated poor benefit after failure of platinum-based chemotherapy in advanced non-squamous non-small-cell lung cancer (nsNSCLC).
METHODS


In this multicentre, open-label phase III trial, patients with advanced nsNSCLC treated with one or two prior lines, including one platinum-based doublet, were centrally randomised to receive 90 mg/m 2  of paclitaxel (D1, D8, D15) plus 10 mg/kg of bevacizumab (D1, D15) every 28 days or docetaxel (75 mg/m 2 ) every 21 days; crossover was allowed after disease progression. Primary end-point was progression-free survival (PFS). ClinicalTrials.gov registration number: NCT01763671.
RESULTS


One hundred sixty six patients were randomised (paclitaxel plus bevacizumab: 111, docetaxel: 55). The median PFS was longer in patients receiving paclitaxel plus bevacizumab than in patients receveing docetaxel [5·4 months versus 3·9 months, adjusted hazard ratio (HR) 0·61 (95% confidence interval [CI]: 0·44-0·86); p = 0·005]. Objective response rates (ORRs) were 22·5% (95% CI: 14·8-30·3) and 5·5% (95% CI: 0·0-11·5) (p = 0·006), respectively. Median overall survivals were similar (adjusted HR 1·17; p = 0·50). Crossover occurred in 21 of 55 (38·2%) docetaxel-treated patients. Grade III-IV adverse events (AEs) were reported in 45·9% and 54·5% of patients treated with paclitaxel and bevacizumab or docetaxel, respectively (p = NS), including neutropenia (19·3% versus 45·4%), neuropathy (8·3% versus 0·0%) and hypertension (7·3% versus 0·0%). Three patients died due to treatment-related AEs (1·8% in each group).
CONCLUSION


Weekly paclitaxel plus bevacizumab as second- or third-line improves PFS and ORR compared with docetaxel in patients with nsNSCLC, with an acceptable safety profile. These results place weekly paclitaxel plus bevacizumab as a valid option in this population.
CLINICAL TRIALS REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT01763671.",2020,Median overall survivals were similar (adjusted HR 1·17; p = 0·50).,"['One hundred sixty six patients were randomised', 'patients with advanced nsNSCLC treated with one or two prior lines, including one platinum-based doublet', '0·61', 'patients with nsNSCLC', 'advanced non-squamous non-small-cell lung cancer (nsNSCLC', 'advanced non-squamous non-small-cell lung cancer']","['Weekly paclitaxel plus bevacizumab', 'docetaxel', '90\xa0mg/m 2  of paclitaxel (D1, D8, D15) plus 10\xa0mg/kg of bevacizumab (D1, D15) every 28 days or docetaxel', 'paclitaxel plus bevacizumab', 'platinum-based chemotherapy', 'paclitaxel and bevacizumab or docetaxel']","['Median overall survivals', 'Grade III-IV adverse events (AEs', 'hypertension', 'neuropathy', 'Objective response rates (ORRs', 'PFS and ORR', 'adjusted hazard ratio (HR', 'progression-free survival (PFS', 'neutropenia', 'median PFS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",166.0,0.224637,Median overall survivals were similar (adjusted HR 1·17; p = 0·50).,"[{'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Univ. Lille, CHU Lille, Thoracic Oncology Dept, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 - UMR-S 1277, Canther, F-59000, Lille, France. Electronic address: alexis.cortot@chru-lille.fr.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Service de Pneumologie, CHITS Sainte Musse, Toulon, France. Electronic address: clarisse.audigier-valette@ch-toulon.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Service des Maladies Respiratoires, Centre Hospitalier Général, Le Mans, France. Electronic address: omolinier@ch-lemans.fr.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Service de Pneumologie, Institut Bergonié, Bordeaux, France. Electronic address: s.le-moulec@bordeaux.unicancer.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, Assistance Public Hôpitaux de Marseille. Multidisciplinary Oncology & Therapeutic Innovations Dpt, Marseille, France. Electronic address: fabrice.barlesi@ap-hm.fr.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': ""Service D'oncologieThoracique, Hopital Bichat Claude Bernard, Paris, France. Electronic address: gerard.zalcman@aphp.fr.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dumont', 'Affiliation': 'Centre Hospitalier, Chauny, France. Electronic address: dr.dumont@ch-chauny.fr.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Pouessel', 'Affiliation': ""Service D'Oncologie Médicale, Hôpital Saint-Louis, Paris, France. Electronic address: pouessel.damien@iuct-oncopole.fr.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Poulet', 'Affiliation': 'Service de Pneumologie, CHU - Groupe Hospitalier Sud, Amiens, France. Electronic address: poulet.claire@chu-amiens.fr.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fontaine-Delaruelle', 'Affiliation': 'Centre Hospitalier Universitaire Lyon Sud, Pierre Bénite, France. Electronic address: clara.fontaine-delaruelle@chu-lyon.fr.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hiret', 'Affiliation': ""Institut de Cancérologie de L'Ouest - René Gauducheau-Saint Herblain, France. Electronic address: sandrine.hiret@ico.unicancer.fr.""}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Dixmier', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier Régional, Orléans, France. Electronic address: adrien.dixmier@chr-orleans.fr.'}, {'ForeName': 'Patrick-Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier, Pau, France. Electronic address: aldo.renault@ch-pau.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Becht', 'Affiliation': 'Oncologie Médicale, Clinique de Clémentville, Montpellier, France. Electronic address: catherine.becht@laposte.net.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Raffy', 'Affiliation': 'Service de Pneumologie, CH Louis Pasteur, Chartres, France. Electronic address: raffy.olivier@neuf.fr.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Dayen', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier, Saint Quentin, France. Electronic address: c.dayen@ch-stquentin.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Service de Pneumologie, Hôpital Larrey, Toulouse, France. Electronic address: mazieres.j@chu-toulouse.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Service de Pneumologie, CHRU Bretonneau, Tours, France. Electronic address: e.pichon@chu-tours.fr.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France. Electronic address: alexandra.langlais@ifct.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France. Electronic address: franck.morin@ifct.fr.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France; Thoracic Oncology Unit, PTV, CHU Grenoble-Alpes CS10217, 38043, Grenoble, France. Electronic address: DMoro-Sibilot@chu-grenoble.fr.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Cancer Medecine Department, Gustave Roussy, Villejuif, France; Paris-Saclay University, Orsay, France. Electronic address: benjamin.besse@gustaveroussy.fr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.022']
82,32179428,The effects of repeated transcranial direct current stimulation on sleep quality and depression symptoms in patients with major depression and insomnia.,"IMPORTANCE


Although several strategies using transcranial direct current stimulation (tDCS) have been investigated to treat major depressive disorder (MDD), the efficacy of this treatment for patients with MDD who also have insomnia is unclear.
OBJECTIVE


To observe the effects of tDCS on sleep quality and depressive symptoms in patients with MDD who have insomnia.
METHODS


We conducted a randomized, double-blinded study involving adults with major depression and insomnia. We randomly assigned patients to either add tDCS or to sham tDCS to their regular treatment. After randomization, we treated a total of 90 patients at the Kangning Hospital, Ningbo, China. We allocated 47 patients to the tDCS group and 43 to the sham tDCS group. The tDCS treatment procedure included 20 sessions of 2-mA stimulation of the dorsolateral prefrontal cortex (DLPFC) for 30 min, which was followed by four weekly treatments. The anode and cathode electrodes were placed on the left and right DLPFC, respectively. We recorded the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG) at Day 1 and Day 28.
RESULTS


Compared with the sham tDCS group, the active tDCS group showed improved total scores of SAS and SDS. PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment. We also observed that tDCS affected sleep architecture, by increasing total sleep time and improving sleep efficiency through PSG.
CONCLUSIONS


Our study demonstrated the effect of tDCS on sleep quality and depressive symptoms in patients with MDD and insomnia. These results suggested that tDCS stimulation not only improved symptoms of depression and anxiety but also had a positive effect on sleep quality in patients with MDD. For patients with depression and insomnia, tDCS stimulation could be a good supplement to drugs.",2020,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","['90 patients at the Kangning Hospital, Ningbo, China', 'patients with MDD', 'patients with MDD and insomnia', 'patients with major depression and insomnia', '47 patients to the tDCS group and 43 to the sham tDCS group', 'patients with MDD who have insomnia', 'adults with major depression and insomnia']","['tDCS', 'transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'tDCS or to sham tDCS']","['total scores of SAS and SDS', 'sleep quality and depression symptoms', 'PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency', 'sleep quality', 'Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG', 'symptoms of depression and anxiety', 'total sleep time', 'sleep quality and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",90.0,0.0527442,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Haihang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhiwang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China. Electronic address: wyzhouds@sina.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.003']
83,32185417,"Effect of an ecosystem-centered community participation programme on the incidence of dengue. A field randomized, controlled trial.","OBJECTIVES


The purpose of this study is to analyse the effect of a community participation programme based on the ecosystem model on the incidence of dengue in urban communities.
METHODS


A randomized controlled field trial was conducted in the state of Colima, Mexico. The intervention consisted of a community participation programme focused on the ecosystem; simultaneously, the control groups were communities that only received the usual official prevention programs. The incidence of dengue was estimated in people of both groups due to the appearance of de novo IgM antibodies during the follow-up period.
RESULTS


The incidence of dengue in the intervened group was 2.58%/month (n = 818) and in control group 2.26%/month (n = 994), with a risk ratio of 1.14 (95% CI 0.89-1.45) and a PAF of 0.06 (95% CI - 0.056 to 0.16). The A. aegypti larval density (Breteau Index) was reduced in the treated group.
CONCLUSIONS


The implementation of a community participation programme in the cities of Colima, Mexico, showed a slightly counterproductive effect on the incidence of dengue. This happened even with a reduction in the A. aegypti index.",2020,"The A. aegypti larval density (Breteau Index) was reduced in the treated group.
",['urban communities'],"['community participation programme focused on the ecosystem; simultaneously, the control groups were communities that only received the usual official prevention programs', 'community participation programme', 'ecosystem-centered community participation programme']","['incidence of dengue', 'aegypti larval density (Breteau Index']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009476', 'cui_str': 'Community Participation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0302488,"The A. aegypti larval density (Breteau Index) was reduced in the treated group.
","[{'ForeName': 'Oscar Alberto', 'Initials': 'OA', 'LastName': 'Newton-Sánchez', 'Affiliation': 'Facultad de Medicina, Universidad de Colima, Avenida Universidad 333, 28040, Colima City, Mexico.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'de la Cruz Ruiz', 'Affiliation': 'Facultad de Medicina, Universidad de Colima, Avenida Universidad 333, 28040, Colima City, Mexico.'}, {'ForeName': 'Yisel', 'Initials': 'Y', 'LastName': 'Torres-Rojo', 'Affiliation': 'Instituto de Medicina Tropical Pedro Kouri, Avenida Novia del Mediodía, KM 6 1/2, La Lisa, 11400, Havana, Cuba.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Ochoa-Diaz-López', 'Affiliation': 'Instituto de la Frontera Sur (ECOSUR), Carretera Panamericana y Periférico Sur S/N Barrio de María Auxiliadora San Cristóbal de Las Casas, 29290, Chiapas, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Delgado-Enciso', 'Affiliation': 'Facultad de Medicina, Universidad de Colima, Avenida Universidad 333, 28040, Colima City, Mexico.'}, {'ForeName': 'Carlos Moises', 'Initials': 'CM', 'LastName': 'Hernandez-Suarez', 'Affiliation': 'Facultad de Medicina, Universidad de Colima, Avenida Universidad 333, 28040, Colima City, Mexico.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Espinoza-Gomez', 'Affiliation': 'Facultad de Medicina, Universidad de Colima, Avenida Universidad 333, 28040, Colima City, Mexico. fespin@ucol.mx.'}]",International journal of public health,['10.1007/s00038-020-01345-y']
84,31981712,Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure.,"BACKGROUND


Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S.
POPULATION


Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care.
AIMS/OBJECTIVES


To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research.
METHODS


The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects.
CONCLUSION


This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.",2020,To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist.,"['Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95\u202fmmHg at two consecutive visits', '21 primary care clinics (9 clinic-based care, 12 telehealth care']","['telehealth care and best practice clinic-based care', 'two evidence-based blood pressure care strategies']","['change in key patient-reported outcomes over 6\u202fmonths as measured by surveys', 'blood pressure (BP', 'change in systolic BP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",21.0,0.109871,To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist.,"[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America. Electronic address: Karen.L.Margolis@Healthpartners.com.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Bergdall', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'MarySue', 'Initials': 'M', 'LastName': 'Beran', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Anderson', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Leif I', 'Initials': 'LI', 'LastName': 'Solberg', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Pamala A', 'Initials': 'PA', 'LastName': 'Pawloski', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Jeanette Y', 'Initials': 'JY', 'LastName': 'Ziegenfuss', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rehrauer', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Haugen', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Av, Seattle, WA 98101, United States of America.'}, {'ForeName': 'Zeke', 'Initials': 'Z', 'LastName': 'McKinney', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kodet', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Appana', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Trower', 'Affiliation': 'HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'RaeAnn', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'HealthPartners, Mailstop 31100A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Crabtree', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Department of Family Medicine and Community Health, New Brunswick, NJ 08901, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105939']
85,32333328,The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.,"INTRODUCTION


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


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


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


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


ClinicalTrials.gov identifier, NCT01929031.",2020,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","['patients with moderate or severe baseline pain', ""patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain"", '237 patients with moderate pain and 325 with severe pain at baseline', 'Patients with Acute Postoperative Dental Pain', 'patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain']","['ibuprofen', 'ibuprofen 400\xa0mg and caffeine', 'FDC versus ibuprofen, caffeine and placebo', 'ibuprofen/caffeine FDC versus ibuprofen', 'Ibuprofen/Caffeine', 'FDC versus ibuprofen', 'ibuprofen 400\xa0mg/caffeine 100\xa0mg FDC, ibuprofen 400\xa0mg, caffeine 100\xa0mg or placebo']","['analgesic efficacy', 'Pain relief (PAR) and pain intensity', 'moderate pain, PID', 'PID', 'time-weighted sum of PAR and pain intensity difference (PID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0984276', 'cui_str': 'Caffeine 100 MG'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",237.0,0.652098,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Förderreuther', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians University, Munich, Germany. sfoerder@med.uni-muenchen.de.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lampert', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Global Medical Consumer Health Care, Sanofi-Aventis Groupe, Gentilly, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weiser', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01297-y']
86,32276630,Effects of a ketogenic diet on body composition and strength in trained women.,"BACKGROUND


The effect of ketogenic diets (KD) on body composition in different populations has been investigated. More recently, some have recommended that athletes adhere to ketogenic diets in order to optimize changes in body composition during training. However, there is less evidence related to trained women. We aimed to evaluate the effect of a KD on body composition and strength in trained women following an eight-week resistance training (RT) program.
METHODS


Twenty-one strength-trained women (27.6 ± 4.0 years; 162.1 ± 6.6 cm; 62.3 ± 7.8 kg; 23.7 ± 2.9 kg·m - 2 ) were randomly assigned to either a non-KD group (n = 11, NKD) or a KD group (n = 10, KD). Study outcomes included body composition as measured by dual-energy X-ray absorptiometry (DXA), strength levels measured using one maximum repetition (RM) in back squat and bench press (BP), and countermovement jump (CMJ) measured on a force plate.
RESULTS


A significant reduction in fat mass was observed in KD (- 1.1 ± 1.5 kg; P = 0.042; d = - 0.2) but not in NDK (0.3 ± 0.8 kg; P = 0.225; d = 0.1). No significant changes in fat-free mass were observed in KD (- 0.7 ± 1.7 kg; P = 0.202; d = - 0.1) or NKD (0.7 ± 1.1 kg; P = 0.074; d = 0.2), but absolute changes favored NKD. No significant changes in BP were observed in KD (1.5 ± 4.6 kg; P = 0.329; d = 0.2), although significant changes were noted in the squat and CMJ (5.6 ± 7.6 kg; P = 0.045; d = 0.5 and 2.2 ± 1.7 kg; P = 0.022; d = 0.6, respectively). In contrast, NKD showed significant increases in BP (4.8 ± 1.8; P < 0.01; d = 0.7), squat (15.6 ± 5.4 kg; P = 0.005; d = 1.4) and CMJ (22.0 + 4.2 cm; P = 0.001; d = 0.5).
CONCLUSIONS


Findings indicate that a KD may help to decrease fat mass and maintain fat-free mass after eight 8 weeks of RT in trained-women but is suboptimal for increasing fat-free mass.",2020,"In contrast, NKD showed significant increases in BP (4.8 ± 1.8; P < 0.01; d = 0.7), squat (15.6 ± 5.4 kg; P = 0.005; d = 1.4) and CMJ (22.0 + 4.2 cm; P = 0.001; d = 0.5).
","['trained women', 'trained women following an eight-week resistance training (RT) program', 'Twenty-one strength-trained women (27.6\u2009±\u20094.0\u2009years; 162.1\u2009±\u20096.6\u2009cm; 62.3\u2009±\u20097.8\u2009kg; 23.7\u2009±\u20092.9\u2009kg·m -\u20092 ']","['ketogenic diet', 'KD', 'ketogenic diets (KD']","['squat and CMJ', 'body composition and strength', 'fat mass', 'fat mass and maintain fat-free mass', 'fat-free mass', 'body composition as measured by dual-energy X-ray absorptiometry (DXA), strength levels measured using one maximum repetition (RM) in back squat and bench press (BP), and countermovement jump (CMJ) measured on a force plate', 'BP']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]",21.0,0.0455182,"In contrast, NKD showed significant increases in BP (4.8 ± 1.8; P < 0.01; d = 0.7), squat (15.6 ± 5.4 kg; P = 0.005; d = 1.4) and CMJ (22.0 + 4.2 cm; P = 0.001; d = 0.5).
","[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Vargas-Molina', 'Affiliation': 'Human Kinetics and Body Composition Laboratory, University of Málaga, Bulevar Louis Pasteur, 25, 29010, Málaga, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Petro', 'Affiliation': 'Research Group in Physical Activity, Sports and Health Sciences (GICAFS), Universidad de Córdoba, Montería, Colombia.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Romance', 'Affiliation': 'Human Kinetics and Body Composition Laboratory, University of Málaga, Bulevar Louis Pasteur, 25, 29010, Málaga, Spain.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Kreider', 'Affiliation': 'Exercise & Sport Nutrition Lab, Human Clinical Research Facility, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, CUNY Lehman College, New York, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Bonilla', 'Affiliation': 'Research Division, DBSS INTERNATIONAL SAS, Bogotá, Colombia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Benítez-Porres', 'Affiliation': 'Human Kinetics and Body Composition Laboratory, University of Málaga, Bulevar Louis Pasteur, 25, 29010, Málaga, Spain. benitez@uma.es.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00348-7']
87,32305531,Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure for colorectal liver metastasis.,"Since first described, Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) has garnered boisterous praise and fervent criticism. Its rapid adoption and employment for a variety of indications resulted in high perioperative morbidity and mortality. However recent risk stratification, refinement of technique to reduce the impact of stage I and progression along the learning curve have resulted in improved outcomes. The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability and survival following ALPPS. In this review, as ALPPS enters the thirteenth year since conception, the current status of this contentious two stage technique is presented and best practices for deployment in the treatment of CRLM is codified.",2020,The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability following ALPPS.,['colorectal liver metastases (CRLM'],"['Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS', 'stage hepatectomy (TSH', 'ALPPS', 'Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) Procedure']",[],"[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0301811', 'cui_str': 'Alkaline phosphatase isoenzyme, placental fraction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0558555,The first randomized trial comparing ALPPS to two stage hepatectomy (TSH) for colorectal liver metastases (CRLM) was recently published demonstrating comparable perioperative morbidity and mortality with improved resectability following ALPPS.,"[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hernandez-Alejandro', 'Affiliation': 'Department of Surgery and Division of Abdominal Transplantation and Hepatobiliary Surgery, University of Rochester Medical Center, Rochester, USA. Electronic address: Roberto_Hernandez@urmc.rochester.edu.'}, {'ForeName': 'Luis I', 'Initials': 'LI', 'LastName': 'Ruffolo', 'Affiliation': 'Department of Surgery and Division of Abdominal Transplantation and Hepatobiliary Surgery, University of Rochester Medical Center, Rochester, USA.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Alikhanov', 'Affiliation': 'Department of Liver and Pancreatic Surgery, Clinical Research Center of Moscow, Moscow, Russia.'}, {'ForeName': 'Bergthor', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Department of Surgery in Linköping, And Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Orlando Jorge M', 'Initials': 'OJM', 'LastName': 'Torres', 'Affiliation': 'Department of Gastrointestinal Surgery, Hepatopancreatobiliary Unit, University Hospital and School of Medicine, Federal University of Maranhão, São Luís, Brazil.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Serrablo', 'Affiliation': 'Division of Surgery, Miguel Servet University Hospital and University of Zaragoza School of Medicine, Zaragoza, Spain.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.009']
88,32330373,"Dietary supplementation with a novel l-carnitine multi-micronutrient in idiopathic male subfertility involving oligo-, astheno-, teratozoospermia: A randomized clinical study.","OBJECTIVE


To study the influence of a multi-component nutrient dietary supplement on sperm parameters and pregnancy rates in idiopathic male infertility (IMI) with oligo-, astheno-, and teratozoospermia.
DESIGN


A randomized, double-blind, placebo-controlled, prospective, parallel arms (1:1 allocation ratio), multi-center clinical trial.
SETTINGS


Eight urology/reproductive health clinical centers located in Ukraine.
PATIENTS


Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology < 4%.
INTERVENTION(S)


Patients were randomly allocated verum test dietary supplement (TDS) containing l-carnitine/acetyl-l-carnitine, l-arginine, glutathione, co-enzyme Q10, zinc, vitamin B 9  , vitamin B 12  , selenium, or placebo 1 time daily for 6 months.
MAIN OUTCOME(S)


The primary outcome measure was the percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms) at month 0, 2, and 4. The percentage of pregnancies served the secondary outcome endpoint. Differences between the groups were assessed in z-test for proportions.
RESULTS


All males finished the study. At month 4, 29/42 (69.0%) males in the verum and 9/41 (22.0%) had normal spermiograms (P < .001). The percentage of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = .017). There were no reportable supplement-associated adverse events.
CONCLUSION


Specific multi-nutrient combination l-carnitine/l-acetyl-carnitine, l-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium can improve sperm quality in males with IMI and increase pregnancy rates.",2020,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","['Eight urology/reproductive health clinical centers located in Ukraine', 'males with IMI and increase pregnancy rates', 'idiopathic male subfertility involving oligo-, astheno-, teratozoospermia', 'Eighty-three males aged 21-50 years with IMI and at least 1 of 3 abnormal values: total sperm concentration < 15 million/ml or/and spermatozoa progressive motility < 32% or/and forms with normal morphology <4', 'idiopathic male infertility (IMI) with oligo-, astheno-, teratozoospermia']","['Specific multi-nutrient combination L-carnitine/ L-acetyl-carnitine, L-arginine, glutathione, co-enzyme-Q, zinc, folic acid, cyanocobalamin, and selenium', 'multicomponent nutrient dietary supplement', 'placebo', 'Dietary supplementation with a novel L-carnitine multi-micronutrient', 'verum test dietary supplement (TDS) containing L-carnitine/acetyl-L-carnitine, L-arginine, glutathione, co-enzyme-Q10, zinc, vitamin B 9  , vitamin B 12  , selenium or placebo']","['normal spermiograms', 'sperm parameters and pregnancy rates', 'spontaneous pregnancies', 'sperm quality', 'percentage of normal spermiograms (concentration ≥ 15 million/ml and ≥ 32% of spermatozoa with progressive motility and ≥ 4% of normal forms']","[{'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0848676', 'cui_str': 'Sub-Fertility, Male'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0403824', 'cui_str': 'Teratozoospermia'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C3854382', 'cui_str': 'Spermatozoa progressive motility'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0085798', 'cui_str': 'Glycogen Branching Enzyme'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1960956', 'cui_str': 'Million/milliliter'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",83.0,0.423096,"Percent of spontaneous pregnancies in the verum group was greater than in the placebo group (10/42, 23.8% vs. 2/41, 4.9%, respectively, P = 0.017).","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kopets', 'Affiliation': 'Medical Center ""Astar"", Lviv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Kuibida', 'Affiliation': 'Precarpathian Center of Reproductive Health, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Chernyavska', 'Affiliation': 'Mykolaiv State Clinical Hospital, Mykolaiv, Ukraine.'}, {'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Cherepanyn', 'Affiliation': 'Lviv State Center for the Reproductive Health, Lviv, Ukraine.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Mazo', 'Affiliation': 'Private Urologic Practice, Mykolaiv, Ukraine.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Fedevych', 'Affiliation': 'Lviv State Hospital, Lviv, Ukraine.'}, {'ForeName': 'Sergiy', 'Initials': 'S', 'LastName': 'Gerasymov', 'Affiliation': 'MedianaStatistics, Lviv, Ukraine.'}]",Andrology,['10.1111/andr.12805']
89,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs.
METHODS


In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed.
RESULTS


After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes.
CONCLUSIONS


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
90,32312261,Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial.,"BACKGROUND


Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment.
METHODS


AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects.
RESULTS


The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients.
CONCLUSIONS


The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR.
TRIAL REGISTRATION


Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.",2020,The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups.,"['allergic rhinitis', 'patients with AR', 'AR patients']","['Ginger extract versus Loratadine', 'ginger extract', 'loratadine', 'ginger extract 500\u2009mg (n\u2009=\u200940) against those treated with loratadine']","['blood pressure', 'TNSS scores', 'blood pressure, blood analysis and history-taking for side effects', 'estimated volume of the nasal cavity', 'nasal symptoms and quality of life', 'drowsiness, fatigue, dizziness and constipation', 'efficacy and safety', 'total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0939895', 'cui_str': 'Ginger extract'}, {'cui': 'C0065180', 'cui_str': 'Loratadine'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0430619', 'cui_str': 'Acoustic rhinometry'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.138238,The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups.,"[{'ForeName': 'Rodsarin', 'Initials': 'R', 'LastName': 'Yamprasert', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Waipoj', 'Initials': 'W', 'LastName': 'Chanvimalueng', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Nichamon', 'Initials': 'N', 'LastName': 'Mukkasombut', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.'}, {'ForeName': 'Arunporn', 'Initials': 'A', 'LastName': 'Itharat', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand. iarunporn@yahoo.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-2875-z']
91,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
92,32316984,Protocol for a randomised trial testing a community fibrosis assessment service for patients with suspected non-alcoholic fatty liver disease: LOCal assessment and triage evaluation of non-alcoholic fatty liver disease (LOCATE-NAFLD).,"BACKGROUND


Non-alcoholic fatty liver disease (NAFLD) is the most common type of chronic liver disease in Australia and its recent increase mirrors the obesity and type 2 diabetes epidemics. Currently, many patients who present to primary care with abnormal liver function tests or steatosis on liver ultrasound are referred for assessment in secondary care. Due to the large number of patients with NAFLD, this results in long waits for clinical and fibrosis assessment, placing unnecessary burden on the public hospital system.
METHODS


We will conduct a 1:1 parallel randomised trial to compare two alternative models of care for NAFLD. Participants will be randomised to usual care or the LOCal Assessment and Triage Evaluation (LOCATE) model of care and followed for 1 year. We will recruit patients from the non-neighbouring Sunshine Coast and Metro South Hospital and Health Services (HHSs) in Queensland, Australia. Our primary outcome of interest is time to diagnosis of high-risk NAFLD, based on the number of participants in each arm of the study who receive a diagnosis of clinically significant fibrosis. Two hundred and 34 participants will give us a 95% power to detect a 50% reduction in the primary outcome of time to diagnosis of high-risk disease. We will also conduct an economic evaluation, evaluating the cost-effectiveness of the new model of care. We will also evaluate the implementation of the new model of care.
DISCUSSION


It is anticipated that the results of this study will provide valuable new information regarding the management of NAFLD in the Australian setting. A relatively simple change to care could result in earlier identification of patients with significant liver disease and lower overall costs for the health system. Results will be directly disseminated to key staff for further distribution to consumers, policy- and decision-makers in the form of evidence briefs, plain language summaries and policy recommendations.
TRIAL REGISTRATION


The trial was registered on 30 January, 2020 and can be found via ANZCTR - number ACTRN12620000158965.",2020,A relatively simple change to care could result in earlier identification of patients with significant liver disease and lower overall costs for the health system.,"['Two hundred and 34 participants', 'patients who present to primary care with abnormal liver function tests or steatosis on liver ultrasound are referred for assessment in secondary care', 'patients with suspected non-alcoholic fatty liver disease', 'patients from the non-neighbouring Sunshine Coast and Metro South Hospital and Health Services (HHSs) in Queensland, Australia']",['community fibrosis assessment service'],"['time to diagnosis of high-risk NAFLD', 'time to diagnosis of high-risk disease']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0412534', 'cui_str': 'Ultrasonography of liver'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1553702', 'cui_str': 'Neighbor'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0587538', 'cui_str': 'Assessment service'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.159975,A relatively simple change to care could result in earlier identification of patients with significant liver disease and lower overall costs for the health system.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brain', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, GPO Box 2434, Brisbane, QLD, 4001, Australia. david.brain@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""O'Beirne"", 'Affiliation': 'University of the Sunshine Coast, Locked bag 4, Maroochydore DC, QLD, 4558, Australia.'}, {'ForeName': 'Ingrid J', 'Initials': 'IJ', 'LastName': 'Hickman', 'Affiliation': 'The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Powell', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Valery', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Locked bag 2000, Royal Brisbane Hospital, QLD, 4029, Australia.'}, {'ForeName': 'Sanjeewa', 'Initials': 'S', 'LastName': 'Kularatna', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, GPO Box 2434, Brisbane, QLD, 4001, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tulleners', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, GPO Box 2434, Brisbane, QLD, 4001, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, GPO Box 2434, Brisbane, QLD, 4001, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Horsfall', 'Affiliation': 'The University of Queensland, St Lucia, QLD, 4072, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, GPO Box 2434, Brisbane, QLD, 4001, Australia.'}]",BMC health services research,['10.1186/s12913-020-05233-2']
93,32330925,Effects of serotonin and dopamine depletion on neural prediction computations during social learning.,"We have previously shown that individuals with high depression scores demonstrate impaired behavioral and neural responses during social learning. Given that depression is associated with altered dopamine (DA) and serotonin (5-HT) functioning, the current study aimed to elucidate the role of these neurotransmitters in the social learning process using a dietary depletion manipulation. In a double-blind design, 70 healthy volunteers were randomly allocated to a 5-HT depletion (N = 24), DA depletion (N = 24), or placebo (N = 22) group. Participants performed a social learning task during fMRI scanning, as part of which they learned associations between name cues and rewarding (happy faces) or aversive (fearful faces) social outcomes. Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group. On the neural level, computational modeling-based fMRI analyses revealed that 5-HT depletion altered social reward prediction signals in the insula, temporal lobe, and prefrontal cortex, while DA depletion affected social reward prediction encoding only in the prefrontal cortex. These results indicate that 5-HT depletion impairs learning from social rewards, on both the behavioral and the neural level, while DA depletion has a less extensive effect. Interestingly, the behavioral and neural responses observed after 5-HT depletion in the current study closely resemble our previous findings in individuals with high depression scores using the same task. It may thus be the case that decreased 5-HT levels contribute to social learning deficits in depression.",2020,"Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group.","['70 healthy volunteers', 'individuals with high depression scores', 'neural prediction computations during social learning']","['5-HT depletion (N\u2009=\u200924), DA depletion (N\u2009=\u200924), or placebo', 'serotonin and dopamine depletion', 'social learning task during fMRI scanning, as part of which they learned associations between name cues and rewarding (happy faces) or aversive (fearful faces) social outcomes']",['social reward learning'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",70.0,0.0161143,"Behaviorally, 5-HT depleted subjects demonstrated impaired social reward learning compared to placebo controls, with a marginal effect in the same direction in the DA depletion group.","[{'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Frey', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK. c.mccabe@reading.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0678-z']
94,32194251,Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial.,"BACKGROUND


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


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


pRESTO will be among the first studies to evaluate treatment options for individuals primarily using synthetic street opioids, providing important evidence to guide treatment strategies for this population.",2020,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","['Participants will be 298 clinically stable, non-pregnant adults with OUD, recruited from outpatient clinics in Vancouver, Canada, where the majority of the illicit opioids are contaminated with fentanyl']","['methadone, buprenorphine', 'methadone', 'morphine', 'morphine (SROM']","['suppression of illicit opioid use, measured by bi-weekly urine drug screens', 'efficacy rates', ' treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",298.0,0.110341,"Secondary outcomes include: treatment retention, medication safety, overdose events, treatment satisfaction, psychological functioning, changes in drug-related problems, changes in quality of life, opioid cravings, other substance use, and cost-effectiveness.
","[{'ForeName': 'M Eugenia', 'Initials': 'ME', 'LastName': 'Socias', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: bccsu-es@bccsu.ubc.ca.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Rupinder', 'Initials': 'R', 'LastName': 'Brar', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada.'}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Fairbairn', 'Affiliation': 'British Columbia Centre on Substance Use, Vancouver, BC, Canada; Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105993']
95,29733230,Mediational pathways of meditation and exercise on mental health and perceived stress: A randomized controlled trial.,"This study investigated the effects of mindfulness and exercise training on indicators of mental health and stress by examining shared mediators of program effects. Community-recruited adults ( N  = 413) were randomized into one of three conditions: (a) mindfulness-based stress reduction, (b) moderate intensity exercise, or (c) wait-list control. Composite indicator structural equation models estimated direct, indirect, and total effects. Results showed that mindfulness-based self-efficacy fulfilled a prominent role in mediating meditation and exercise program effects. Findings suggest that mindfulness and exercise training share similar mechanisms that can improve global mental health, including adaptive responses to stress.",2020,"Findings suggest that mindfulness and exercise training share similar mechanisms that can improve global mental health, including adaptive responses to stress.",['Community-recruited adults ( N\u2009=\u2009413'],"['exercise training', 'Mediational pathways of meditation and exercise', 'mindfulness-based stress reduction, (b) moderate intensity exercise, or (c) wait-list control', 'mindfulness and exercise training']","['global mental health', 'mental health and perceived stress']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0150277'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",413.0,0.0303804,"Findings suggest that mindfulness and exercise training share similar mechanisms that can improve global mental health, including adaptive responses to stress.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldstein', 'Affiliation': 'University of Wisconsin-Madison, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Topitzes', 'Affiliation': 'University of Wisconsin-Milwaukee, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Brown', 'Affiliation': 'University of Wisconsin-Madison, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': 'University of Wisconsin-Madison, USA.'}]",Journal of health psychology,['10.1177/1359105318772608']
96,30358181,Prevention: Necessary But Insufficient? A 2-Year Follow-Up of an Effective First-Grade Mathematics Intervention.,"We present first-grade, second-grade, and third-grade impacts for a first-grade intervention targeting the conceptual and procedural bases that support arithmetic. At-risk students (average age at pretest = 6.5) were randomly assigned to three conditions: a control group (n = 224) and two variants of the intervention (same conceptual instruction but different forms of practice: speeded [n = 211] vs. nonspeeded [n = 204]). Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant. Many intervention children achieved average mathematics achievement at the end of third grade, and prior math and reading assessment performance predicted which students will require sustained intervention. Finally, projecting impacts 2 years later based on nonexperimental estimates of effects of first-grade math skills overestimates long-term intervention effects.",2020,"Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant.",['At-risk students (average age at pretest\xa0=\xa06.5'],['control group (n\xa0=\xa0224) and two variants of the intervention (same conceptual instruction but different forms of practice: speeded [n\xa0=\xa0211] vs. nonspeeded [n\xa0=\xa0204'],['average mathematics achievement'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",224.0,0.0180623,"Impacts on all first-grade content outcomes were significant and positive, but no follow-up impacts were significant.","[{'ForeName': 'Drew H', 'Initials': 'DH', 'LastName': 'Bailey', 'Affiliation': 'University of California, Irvine.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Gilbert', 'Affiliation': 'Vanderbilt University.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Geary', 'Affiliation': 'University of Missouri.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University.'}]",Child development,['10.1111/cdev.13175']
97,32326815,Effectiveness of a Three-Stage Intervention in Reducing Caregiver Distress During Pediatric Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial.,"More than one fourth of primary caregivers report clinically significant distress during the hematopoietic stem cell transplantation (HSCT) process. Providing early support to primary caregivers could reduce caregiver distress and improve the quality of life. This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization. A two-group comparative study was conducted with repeated measures. Participants were randomly assigned to an intervention group or a control group. The intervention group received the support intervention 5 days before the transplant, 14 days after transplant, and 1 week before hospital discharge. The control group received standard support provided in the hospital ward. Measures were obtained at all three time points from self-report questionnaires, which were related to anxiety, depression, perceived stress, and quality of life. Findings indicated that primary caregivers in the intervention group ( n  = 22) reported significantly lower levels of perceived stress and higher levels of quality of life than the control group ( n  = 23) at 14 days after transplant. In the intervention group, caregiver distress significantly decreased from pretransplant through 14 days after transplant, while over the same period caregiver quality of life significantly increased. The intervention effectively changed the trend of distress and quality of life for caregivers of children during the process of HSCT and hospitalization. The findings of this study suggest that it is important to provide early targeted interventions at critical junctures for caregivers at risk of adverse outcomes.",2020,This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization.,['Pediatric Hematopoietic Stem Cell Transplantation'],"['Three-Stage Intervention', 'three-stage caregiver support intervention']","['Caregiver Distress', 'caregiver quality of life', 'distress and quality of life', 'anxiety, depression, perceived stress, and quality of life', 'levels of perceived stress and higher levels of quality of life', 'caregiver distress', 'quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0539787,This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization.,"[{'ForeName': 'Ying-Mei', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': 'Chang Gung University of Science and Technology, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Wen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Pei-Yin', 'Initials': 'PY', 'LastName': 'Weng', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Tang-Her', 'Initials': 'TH', 'LastName': 'Jaing', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Shih-Hsiang', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220911358']
98,32331937,EPO treatment does not alter acute serum profiles of GFAP and S100B after TBI: A brief report on the Australian EPO-TBI clinical trial.,"PURPOSE


To determine the diagnostic and prognostic value of glial fibrillary acidic protein (GFAP) and S100B after traumatic brain injury (TBI) in an Erythropoietin (EPO) clinical trial and examine whether EPO therapy reduces biomarker concentrations.
MATERIALS AND METHODS


Forty-four patients with moderate-to-severe TBI were enrolled to a sub-study of the EPO-TBI trial. Patients were randomized to either Epoetin alfa 40,000 IU or 1 ml sodium chloride 0.9 as subcutaneous injection within 24 h of TBI.
RESULTS


GFAP and S100B were measured in serum by ELISA from D0 (within 24 h of injury, prior to EPO/vehicle administration) to D5. Biomarker concentrations were compared between injury severities, diffuse vs. focal TBI, 6-month outcome scores (GOS-E) and EPO or placebo treatments. At D0 GFAP was significantly higher than S100B (951 pg/mL vs. 476 pg/mL, p = 0.018). ROC analysis of S100B at 1D post-injury distinguished favorable vs. unfavorable outcomes (area under the curve = 0.73; p = 0.01). EPO did not reduce concentration of either biomarker.
CONCLUSIONS


Elevated serum concentrations of GFAP and S100B after TBI reflect a robust, acute glial response to injury. Consistent with lack of improved outcome in TBI patients treated with EPO and prior findings on neuronal and axonal markers, glial biomarker concentrations and acute profiles were not affected by EPO.",2020,At D0 GFAP was significantly higher than S100B,['Forty-four patients with moderate-to-severe TBI were enrolled to a sub-study of the EPO-TBI trial'],"['S100B', 'EPO', 'EPO therapy', 'Epoetin alfa 40,000\xa0IU or 1\xa0ml sodium chloride', 'glial fibrillary acidic protein (GFAP']","['Biomarker concentrations', 'neuronal and axonal markers, glial biomarker concentrations and acute profiles']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0199970', 'cui_str': 'Erythropoietin therapy'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",44.0,0.140683,At D0 GFAP was significantly higher than S100B,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Hellewell', 'Affiliation': 'University of Sydney, Sydney, Australia; Department of Surgery, Alfred Hospital, Melbourne, Australia; Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. Electronic address: sarah.hellewell@sydney.edu.au.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conquest', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Australian New Zealand Intensive Care Research Centre, Melbourne, Australia.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Vallance', 'Affiliation': 'Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Board', 'Affiliation': 'Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Intensive Care Research, Austin Health, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Australian New Zealand Intensive Care Research Centre, Melbourne, Australia; Department of Intensive Care, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Morganti-Kossmann', 'Affiliation': 'Australian New Zealand Intensive Care Research Centre, Melbourne, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.04.081']
99,32325164,Perineural Dextrose and Corticosteroid Injections for Ulnar Neuropathy at the Elbow: A Randomized Double-blind Trial.,"OBJECTIVE


To assess the effects of perineural corticosteroid and 5% dextrose water (D5W) injections in patients with mild to moderate ulnar neuropathy at the elbow (UNE).
DESIGN


Prospective, randomized, double-blind, controlled trial (6-month follow-up).
SETTING


Outpatients of local medical center settings.
PARTICIPANTS


Patients (N=36) with mild to moderate UNE were randomized, and 33 participants were included in the final data analysis.
INTERVENTIONS


Patients were administered a single perineural injection with 5 mL D5W and 3 mL corticosteroid (triamcinolone acetonide, 10mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively.
MAIN OUTCOME MEASURES


The visual analog scale digital pain or paresthesia/dysesthesia score was the primary outcome. The secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve. The measurement assessment was conducted before and 1, 3, 4, and 6 months after injection.
RESULTS


Thirty-three patients completed the study. Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the third month onward.
CONCLUSIONS


We suggest D5W as a more suitable injectate for perineural injection in patients with UNE.",2020,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","['ulnar neuropathy at the elbow', 'Outpatients of local medical center settings', 'Thirty-six patients with mild-to-moderate UNE were randomized and 33 participants were included in the final data analysis', 'patients with mild-to-moderate ulnar neuropathy at the elbow (UNE', 'Thirty-three patients completed the study']","['perineural corticosteroid and 5% dextrose water', 'Perineural dextrose and corticosteroid injections', 'single perineural injection with 5 mL D5W and 3 mL corticosteroid (10 mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively']","['symptom severity and CSA of the ulnar nerve', 'dysesthesia score', 'Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve', 'visual analog scale digital pain or paresthesia']","[{'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0241057', 'cui_str': 'Burning sensation of skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",36.0,0.570527,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","[{'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Department of Physical Medicine and Rehabilitation, Taichung Armed Forces General Hospital, Taichung City, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Su', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Chia-Kuang', 'Initials': 'CK', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Graduate Institute of Medical Science, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China. Electronic address: crwu98@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.016']
100,32282044,Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life.
Objective


To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks.
Design, Setting, and Participants


This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018.
Intervention


Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention.
Main Outcomes and Measures


The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving.
Results


A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0).
Conclusions and Relevance


This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","['Importance\n\n\nFamily caregivers of persons with advanced heart failure', ""The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner"", 'family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks', 'caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care', 'Family Caregivers of Persons With Advanced Heart Failure', '158 family caregivers', 'Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018', 'family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks']","['Telehealth Early Palliative Care Intervention', 'Intervention\n\n\nFour weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks', 'usual care group received no additional intervention', 'telehealth intervention', 'nurse-led palliative care telehealth intervention']","['global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving', 'Montgomery-Borgatta Caregiver Burden scales', 'mean (SE) Bakas Caregiver Outcomes Scale score', 'Hospital Anxiety and Depression Scale anxiety measure', 'quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",158.0,0.108224,"At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2","[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, The University of Texas at Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Center for Palliative and Supportive Care, Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'University of Alabama at Birmingham School of Nursing.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2583']
101,31471173,"Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans.","Caloric restriction and intermittent fasting are known to prolong life- and healthspan in model organisms, while their effects on humans are less well studied. In a randomized controlled trial study (ClinicalTrials.gov identifier: NCT02673515), we show that 4 weeks of strict alternate day fasting (ADF) improved markers of general health in healthy, middle-aged humans while causing a 37% calorie reduction on average. No adverse effects occurred even after >6 months. ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days. On fasting days, the pro-aging amino-acid methionine, among others, was periodically depleted, while polyunsaturated fatty acids were elevated. We found reduced levels sICAM-1 (an age-associated inflammatory marker), low-density lipoprotein, and the metabolic regulator triiodothyronine after long-term ADF. These results shed light on the physiological impact of ADF and supports its safety. ADF could eventually become a clinically relevant intervention.",2019,"ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days.","['Healthy, Non-obese Humans', 'healthy, middle-aged humans while causing a 37% calorie reduction on average']",['strict alternate day fasting (ADF'],"['levels sICAM-1', 'ADF improved cardiovascular markers, reduced fat mass', 'adverse effects']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.101099,"ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days.","[{'ForeName': 'Slaven', 'Initials': 'S', 'LastName': 'Stekovic', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Hofer', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Tripolt', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Aon', 'Affiliation': 'Experimental Gerontology Section, Translational Gerontology Branch, National Institute on Aging, NIH, Baltimore, MD 21224, USA; Laboratory of Cardiovascular Science, National Institute on Aging, NIH, Baltimore, MD 21224, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Royer', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Pein', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Stadler', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010 Graz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Pendl', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Prietl', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Url', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Schroeder', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Tadic', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eisenberg', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria; NAWI Graz Central Lab Gracia, NAWI Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Magnes', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumpe', 'Affiliation': 'Department of Biology, University of Fribourg, Chemin du Musée 10, 1700 Fribourg, Switzerland.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Zuegner', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bordag', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Kolesnik', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Verheyen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Springer', 'Affiliation': 'Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/, VI 8010 Graz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Madl', 'Affiliation': 'BioTechMed Graz, Graz 8010, Austria; Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/, VI 8010 Graz, Austria.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sinner', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de Cabo', 'Affiliation': 'Experimental Gerontology Section, Translational Gerontology Branch, National Institute on Aging, NIH, Baltimore, MD 21224, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Kroemer', 'Affiliation': ""Equipe 11 labellisée par la Ligue contre le Cancer, Centre de Recherche des Cordeliers, Paris, France; Cell Biology and Metabolomics platforms, Gustave Roussy Cancer Campus, Villejuif, France; INSERM U1138, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Université Pierre et Marie Curie, Paris, France; Pôle de Biologie, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; Karolinska Institute, Department of Women's and Children's Health, Karolinska University Hospital, Stockholm, Sweden; Center of Systems Medicine, Chinese Academy of Science Sciences, Suzhou, China.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Dengjel', 'Affiliation': 'Department of Biology, University of Fribourg, Chemin du Musée 10, 1700 Fribourg, Switzerland; Department of Dermatology, Medical Center, University of Freiburg, Hauptstr. 7, 79104 Freiburg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria; HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madeo', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria. Electronic address: frank.madeo@uni-graz.at.'}]",Cell metabolism,['10.1016/j.cmet.2019.07.016']
102,32325162,Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effectiveness of an individualized comprehensive rehabilitation program (ICPR) on impaired postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain.
DESIGN


Randomized controlled trial.
SETTING


Women with chronic pelvic pain were recruited from the Gynecology Department of the University Hospital San Cecilio in Granada, Spain.
PARTICIPANTS


Participants (N=38) who were randomly divided into 2 groups.
INTERVENTIONS


The intervention group received an 8-week ICRP, and the control group received a leaflet with ergonomic information.
MAIN OUTCOME MEASURES


The main outcomes included were postural control (Mini Balance Evaluation Systems [Mini BESTest] and timed Up and Go [TUG]), pain (Brief Pain Inventory), self-perceived health status (EuroQol 5 dimensions [EQ-5D]), and functionality (Oswestry Disability Index [ODI]).
RESULTS


Significant differences were found between groups in the Mini BESTest and TUG scores with large effect sizes. The Brief Pain Inventory, EQ-5D, and ODI also presented significant differences in the between-groups analysis, with better scores in the intervention group after treatment. In the follow-up analysis, significant differences were found between groups in the Mini BESTest (P<.001), the cognitive TUG subscale (P=.032), interference of pain (P<.001), anxiety and depression (P=.001), and visual analog scale EQ-5D (P=.026) subscales, as well as the ODI (P<.001).
CONCLUSIONS


Our results show significant improvements on postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain who received an 8-week ICRP.",2020,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","['Women with chronic pelvic pain were recruited from the Gynaecology Department of the ""Hospital San Cecilio"" in Granada', '38 participants were included in the study and randomly divided into two groups', 'women with CPP', 'women with chronic pelvic pain']","['Individualized Comprehensive Rehabilitation Program', 'eight-week ICRP and the control group received a leaflet with ergonomic information', 'Individualized Comprehensive Rehabilitation Program (ICPR']","['Mini BESTest and TUG scores', 'VAS EQ-5D', 'interference of pain (p<0.001), anxiety/depression', 'postural control (Mini Balance Evaluation Systems, Mini BESTest and Timed Up and Go Test, TUG), pain (Brief Pain Inventory, BPI), self-perceived health status (Euroqol-5dimensions, EQ-5D) and functionality (Oswestry Disability Index, ODI', 'postural control', 'BPI, EQ-5D and ODI', 'cognitive TUG subscale', 'postural control, pain, self-perceived health status and functionality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",38.0,0.0673424,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: cvalenza@ugr.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.019']
103,31855716,Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.,"For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic ""trial within a registry"" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.",2020,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","['infants undergoing heart surgery with CPB', 'infants (age <\u202f1\u202fyear) undergoing heart surgery with CPB', 'children with heart disease', 'Participants (planned enrollment\u202f=\u202f1,200', 'infants undergoing heart surgery with cardiopulmonary bypass (CPB']","['methylprednisolone', 'placebo', 'CPB pump prime versus placebo', 'corticosteroids', 'perioperative steroids']","['several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications', 'safety and efficacy', 'global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1200.0,0.537948,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'H Scott', 'Initials': 'HS', 'LastName': 'Baldwin', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Bichel', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Butts', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Reid C', 'Initials': 'RC', 'LastName': 'Chamberlain', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Ellis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Hickerson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Marshall L', 'Initials': 'ML', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert Db', 'Initials': 'RD', 'LastName': 'Jaquiss', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Prince J', 'Initials': 'PJ', 'LastName': 'Kannankeril', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Torok', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Turek', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2019.11.016']
104,31647278,Pilot feasibility trial of dual contingency management for cigarette smoking cessation and weight maintenance among weight-concerned female smokers.,"Many women who smoke cigarettes report that concern about weight gain is a barrier to quitting. Indeed, most quitters gain weight and some attribute relapses to weight gain concern. Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently. We conducted a pilot trial to establish the feasibility of dual CM, in which both smoking cessation and weight maintenance were incentivized, as a smoking cessation intervention for female weight-concerned smokers. Participants ( N  = 10) received a 12-week intervention during which they earned financial incentives for smoking abstinence, verified by breath carbon monoxide (CO) testing, and for maintaining their weight (larger incentives for gaining less than five pounds, smaller incentives for 5-10 pound gain) while abstaining from smoking. They attended an end of intervention visit at week 13 and a follow-up visit at week 26. Total compensation was up to $550 ($255 for participation independent of smoking and weight, $145 for smoking abstinence incentives, and $150 for weight maintenance incentives). Results indicated that five of the 10 participants (50%) were continuously abstinent for at least 4 weeks and received at least 2 weight maintenance incentives. Three participants (33%) were abstinent at every visit they attended from quit date through week 26; 2 of these 3 had gained more than 10 pounds by week 26. Additional formative research to test alternative incentive schedules and modalities should be conducted before CM-W is evaluated in a larger trial. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently.","['female weight-concerned smokers', 'Three participants (33%) were abstinent at every visit they attended from quit date through week 26; 2 of these 3 had gained more than 10 pounds by week 26', 'weight-concerned female smokers', 'Participants ( N  = 10']","['smoking cessation intervention', '12-week intervention during which they earned financial incentives for smoking abstinence, verified by breath carbon monoxide (CO) testing, and for maintaining their weight (larger incentives for gaining less than five pounds, smaller incentives for 5-10 pound gain) while abstaining from smoking', 'Contingency management (CM', 'dual contingency management']",['Total compensation'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0439219', 'cui_str': 'lb'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",2019.0,0.017117,"Contingency management (CM), which refers to reinforcing a target behavior with financial incentives, has been demonstrated effective for promoting smoking abstinence and weight management independently.","[{'ForeName': 'Erika Litvin', 'Initials': 'EL', 'LastName': 'Bloom', 'Affiliation': 'Alpert Medical School of Brown University.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hunt', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tidey', 'Affiliation': 'Brown University School of Public Health.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Alpert Medical School of Brown University.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000331']
105,31586602,Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.,"BACKGROUND


Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective.
OBJECTIVE


The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer.
STUDY DESIGN


The Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery.
RESULTS


Of 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ≥2 or ≥3 or a serious adverse event, respectively. The incidence of intraoperative grade ≥2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, -3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ≥2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, -2.2 to 14.7%; P=.14).
CONCLUSION


For early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.",2020,The incidence of intraoperative grade 2+ adverse events was 12% (34/279 patients) in the minimally invasive versus 10% (26/257) in the open group (p=0.45).,"['early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection', '631 patients randomized, 536 (85', 'mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent', '2008 and 2017, in which surgeons from 33 tertiary gynecological cancer centers in 24 countries randomized 631 women International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to either', 'early cervical cancer']","['minimally invasive (n = 319) or open radical hysterectomy', 'open radical hysterectomy', 'minimally invasive versus open radical hysterectomy', 'minimally invasive radical hysterectomy']","['risk of recurrence and death', 'overall incidence of postoperative grade 2+ adverse events', 'Incidence of adverse events', 'overall incidence of intraoperative or postoperative adverse events', 'incidence of intraoperative grade 2+ adverse events', 'incidence of intra and postoperative adverse events']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C1112682', 'cui_str': 'Excision of retroperitoneal lymph node group'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1 (qualifier value)'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",631.0,0.283693,The incidence of intraoperative grade 2+ adverse events was 12% (34/279 patients) in the minimally invasive versus 10% (26/257) in the open group (p=0.45).,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia. Electronic address: Obermair@powerup.com.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogotá and Clínica de Oncología Astorga, Medellín, Colombia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marques', 'Affiliation': 'Gynecologic Oncology Division, Oncologic Center, Hospital Israelita Albert Einstein, São Paulo-SP, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rendon', 'Affiliation': 'Instituto de Cancerologia-Las Americas, Medellín, Colombia.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Surgery, Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tsunoda', 'Affiliation': 'Department of Surgery, Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Behan', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, University of Queensland, Centre for Clinical Research, RBWH, Herston, QLD Australia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza MB, Italy.'}, {'ForeName': 'Marcus Q', 'Initials': 'MQ', 'LastName': 'Bernadini', 'Affiliation': 'Department of Gynecologic Oncology, Princess Margaret Cancer Center, Ontario, Canada.'}, {'ForeName': 'Hongqin', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical College, Ouhai, Wenzhou, China.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Department of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma, Norman, OK.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Division of Gynecologic Oncology, Women's Cancer Center of Nevada, LV.""}, {'ForeName': 'Shuzhong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Naven', 'Initials': 'N', 'LastName': 'Chetty', 'Affiliation': 'Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane, QLD, Australia.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': 'Gynecologic Oncology Division, Oncologic Center, Hospital Israelita Albert Einstein, São Paulo-SP, Brazil.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': ""Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital and The University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, Sydney, NSW Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Salvo', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.09.036']
106,32329527,"Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES).","OBJECTIVE


To evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor-related epilepsy (BTRE), and to evaluate patients' global impression of change and quality of life (QoL).
METHODS


This was a prospective, multicenter, single-arm, noninterventional study with a 6-month observation period (EP0045; NCT02276053). Eligible patients (≥16 years old) had active BTRE secondary to low-grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline. Lacosamide was initiated by the treating physician in the course of routine clinical practice. Primary outcomes were 50% responders (≥50% reduction in focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC) at month 6. Secondary outcomes included seizure-free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5-Level EuroQol-5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory-Brain Tumor) from baseline to month 6, and Kaplan-Meier estimated 6-month retention on lacosamide. Safety variables included adverse drug reactions (ADRs).
RESULTS


Patients were recruited from 24 sites in Europe. Ninety-three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28 days [range = 1-280]), of whom 79 (84.9%) completed the study. At 6 months, 66 of 86 (76.7%) patients were 50% responders and 30 of 86 (34.9%) were seizure-free. Improvements on PGIC were reported by 49 of 76 (64.5%) patients. Based on CGIC, 52 of 81 (64.2%) patients improved. QoL and symptoms outcome measures remained stable. Kaplan-Meier estimated 6-month retention rate was 86.0% (N = 93). Fifteen (16.1%) patients reported ADRs; four (4.3%) had ADRs leading to discontinuation (N = 93).
SIGNIFICANCE


Results of this prospective, noninterventional study suggest that add-on lacosamide is effective and generally well tolerated in patients with BTRE.",2020,"Based on CGIC, 52 of 81 (64.2%) patients improved.","['Patients were recruited from 24 sites in Europe', 'patients with brain tumor-related epilepsy (BTRE', 'patients with BTRE', 'patients with brain tumor-related epilepsy', 'Ninety-three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28\xa0days [range = 1-280]), of whom 79 (84.9%) completed the study', 'Eligible patients (≥16\xa0years old) had active BTRE secondary to low-grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline']","['antiepileptic drugs (AEDs', 'Lacosamide', 'lacosamide']","['seizure-free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5-Level EuroQol-5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory-Brain Tumor) from baseline to month 6, and Kaplan-Meier estimated 6-month retention on lacosamide', 'adverse drug reactions (ADRs', 'PGIC', ""focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC"", 'Kaplan-Meier estimated 6-month retention rate', 'effectiveness and tolerability', 'Effectiveness and tolerability', 'seizure-free']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}]","[{'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}]","[{'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0621912,"Based on CGIC, 52 of 81 (64.2%) patients improved.","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Department of Neuro-Oncology, City of Health and Science and University of Turin, Turin, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Houillier', 'Affiliation': 'AP-HP, Sorbonne Université, IHU, ICM, Public Hospital Network of Paris, Service de Neurologie 2-Mazarin, Hôpitaux, Universitaires La Pitié Salpêtrière - Charles Foix, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maschio', 'Affiliation': 'Center for Tumor-Related Epilepsy, UOSD Neuro-Oncology IRCCS, Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Jaap C', 'Initials': 'JC', 'LastName': 'Reijneveld', 'Affiliation': 'Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Hellot', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Backer', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Joeres', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Leunikava', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glas', 'Affiliation': 'Division of Clinical Neuro-oncology, Department of Neurology, West German Cancer Center and German Cancer Consortium Partner Site, Essen University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.'}]",Epilepsia,['10.1111/epi.16486']
107,32324615,Concentric and Eccentric Resistance Training Comparison on Physical Function and Functional Pain Outcomes in Knee Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the study was to compare the effectiveness of concentrically focused resistance training to eccentrically focused resistance training on physical function and functional pain in knee osteoarthritis.
DESIGN


This is a randomized, single-blinded controlled 4-mo trial. Older adults with knee osteoarthritis (N = 88; 68.3 ± 6.4 yrs, 30.4 ± 6.9 kg/m, and 67.4% women) were randomized to eccentrically focused resistance training, concentrically focused resistance training, or no-exercise control. Main outcomes included chair rise time, stair climb time, 6-min walk test distance, temporal-spatial parameters of gait, community ambulation, and functional pain.
RESULTS


Leg muscle strength improved in both training groups compared with no-exercise control. There were no significant group × time interactions for any functional performance score (chair rise time, stair climb time, 6-min walk test distance, gait parameters, community ambulation). Compared with no-exercise control, functional pain scores were reduced for chair rise (-38.6% concentrically focused resistance training, -50.3% eccentrically focused resistance training vs. +10.0%) and stair climb (-51.6% concentrically focused resistance training, -41.3% eccentrically focused resistance training vs. +80.7%; all P < 0.05). Pain scores were reduced during the 6-min walk and in early recovery with concentrically focused resistance training compared with the remaining two groups (P < 0.05).
CONCLUSIONS


Either resistance exercise type improves activity-related knee osteoarthritis pain, but concentrically focused resistance training more effectively reduced severity of ambulatory pain and pain upon walking cessation.",2020,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","['knee osteoarthritis (OA', 'Knee Osteoarthritis', 'Older adults with knee OA (N=88; 68.3±6.4 yr, 30.4±6.9 kg/m and 67.4% women']","['resistance exercise type', 'concentrically-focused resistance training (CNCRT) to eccentrically-focused resistance training (ECCRT', 'ECCRT, CNCRT or no-exercise control (CON', 'Concentric and Eccentric Resistance Training Comparison']","['physical function and functional pain', 'ambulatory pain and pain upon walking cessation', 'CON, functional pain scores', 'Pain scores', 'functional performance score (chair rise time, stair climb time, six-minute walk test distance, gait parameters, community ambulation', 'Leg muscle strength', 'Physical Function and Functional Pain Outcomes', 'chair rise time, stair climb time, six-minute walk test distance, temporalspatial parameters of gait, community ambulation and functional pain', 'chair rise', 'stair climb', 'activity-related knee OA pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",,0.0567988,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Vincent', 'Affiliation': 'From the Divisions of Physical Medicine and Rehabilitation, Sports Medicine and Research, Department of Orthopaedics and Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001450']
108,32221987,"Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial.","OBJECTIVE


To evaluate long-term safety/tolerability of brivaracetam at individualized doses ≤200 mg/d (primary) and maintenance of efficacy over time (secondary) in adults with focal seizures or primary generalized seizures (PGS) enrolled in phase 3, open-label, long-term follow-up trial N01199 (NCT00150800).
METHODS


Patients ≥16 years of age who had completed double-blind, placebo-controlled adjunctive brivaracetam trials NCT00175825, NCT00490035, NCT00464269, or NCT00504881 were eligible. Outcomes included safety, efficacy, and quality of life.
RESULTS


The safety set included 667 patients (focal seizures, 97.8%; PGS, 2.2%); the efficacy set included 648 patients with focal seizures and 15 patients with PGS. Overall, 49.2% of patients had ≥48 months of exposure. Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%. The most common TEAEs in the focal seizures group (≥15%) were headache (25.3%) and dizziness (21.9%). Mean changes from baseline in Hospital Anxiety and Depression Scale scores at last value during 2-year evaluation were -0.7 (standard deviation [SD] = 4.3) and -0.2 (SD = 4.4) overall. In the focal seizures group, median reduction from baseline in focal seizure frequency/28 days was 57.3%, 50% responder rate was 55.6%, and 6-month and 12-month seizure freedom rates were 30.3% and 20.3%, respectively. Efficacy outcomes improved by exposure duration cohort and then stabilized through the 108-month cohort. Mean improvement from baseline in Patient-Weighted Quality of Life in Epilepsy Inventory total score (efficacy set) was 5.7 (SD = 16.1, Cohen's d = 0.35) at month 12 and 6.5 (SD = 18.0, Cohen's d = 0.36) at month 24.
SIGNIFICANCE


Adjunctive brivaracetam was well tolerated, with a good safety profile in long-term use in adults with epilepsy at individualized doses. Approximately half of the patients remained in the trial at 4 years. Brivaracetam reduced focal seizure frequency versus baseline. Efficacy improved with increasing exposure duration and remained stable through the 9-year cohort.",2020,"Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%.","['patients with epilepsy', '667 patients (focal seizures, 97.8%; PGS, 2.2%); the efficacy set included 648 patients with focal seizures and 15 patients with PGS', 'adults with epilepsy at individualized doses', 'adults with focal seizures or primary generalized seizures (PGS', 'Patients ≥16\xa0years of age who had completed double-blind']","['brivaracetam', 'placebo-controlled adjunctive brivaracetam', 'adjunctive brivaracetam']","['focal seizure frequency', 'headache', 'Long-term safety, efficacy, and quality of life', 'Efficacy outcomes', 'Efficacy', 'brivaracetam discontinuation due to TEAEs', 'seizure freedom rates', 'Patient-Weighted Quality of Life in Epilepsy Inventory total score (efficacy set', 'Hospital Anxiety and Depression Scale scores', 'safety, efficacy, and quality of life', 'dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0234533', 'cui_str': 'Generalized convulsion'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",648.0,0.186291,"Treatment-emergent adverse events (TEAEs) occurred in 91.2% of all patients (91.3% of focal seizures group), brivaracetam discontinuation due to TEAEs in 14.8%, drug-related TEAEs in 56.7%, and serious TEAEs in 22.8%.","[{'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neuroscience, Central Clinical School, Alfred Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Borghs', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Qin Jane', 'Initials': 'QJ', 'LastName': 'He', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina.'}, {'ForeName': 'Anne-Liv', 'Initials': 'AL', 'LastName': 'Schulz', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yates', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Biton', 'Affiliation': 'Clinical Trials Inc, Little Rock, Arkansas.'}]",Epilepsia,['10.1111/epi.16484']
109,32307012,Effects of daily ingestion of sodium bicarbonate on acid-base status and anaerobic performance during an altitude sojourn at high altitude: a randomized controlled trial.,"BACKGROUND


The present study investigated the effects of chronic sodium bicarbonate (NaHCO 3 ) ingestion on a single bout of high-intensity exercise and on acid-base balance during 7-day high-altitude exposure.
METHODS


Ten recreationally active subjects participated in a pre-test at sea level and a 7-day hiking tour in the Swiss Alps up to 4554 m above sea level. Subjects received either a daily dose of 0.3 g/kg NaHCO 3  solution (n = 5) or water as a placebo (n = 5) for 7 days. Anaerobic high-intensity exercise performance was assessed using the portable tethered sprint running (PTSR) test under normoxic and hypoxic conditions (3585 m). PTSR tests assessed overall peak force, mean force, and fatigue index. Blood lactate levels and blood gas parameters were assessed pre- and post-PTSR. Urinary pH and blood gas parameters were further analyzed daily at rest in early morning samples under normoxic and hypoxic conditions.
RESULTS


There were no significant differences between the bicarbonate and control group in any of the PTSR-related parameters. However, urinary pH (p = 0.003, ηp 2  = 0.458), early morning blood bicarbonate concentration (p < 0.001, ηp 2  = 0.457) and base excess (p = 0.002, ηp 2  = 0.436) were significantly higher in the bicarbonate group compared with the control group under hypoxic conditions.
CONCLUSIONS


These results indicate that oral NaHCO 3  ingestion does not ameliorate the hypoxia-induced impairment in anaerobic, high-intensity exercise performance, represented by PTSR-related test parameters, under hypobaric, hypoxic conditions, but the maximal performance measurements may have been negatively affected by other factors, such as poor implementation of PTSR test instructions, pre-acclimatization, the time course of hypoxia-induced renal [HCO 3 - ] compensation, changes in the concentrations of intra- and extracellular ions others than [H + ] and [HCO 3 - ], or gastrointestinal disturbances caused by NaHCO 3  ingestion. However, chronic NaHCO 3  ingestion improves blood bicarbonate concentration and base excess at altitude, which partially represent the blood buffering capacity.",2020,"However, urinary pH (p = 0.003, ηp 2  = 0.458), early morning blood bicarbonate concentration (p < 0.001, ηp 2  = 0.457) and base excess (p = 0.002, ηp 2  = 0.436) were significantly higher in the bicarbonate group compared with the control group under hypoxic conditions.
","['Ten recreationally active subjects participated in a pre-test at sea level and a 7-day hiking tour in the Swiss Alps up to 4554\u2009m above sea level', 'altitude sojourn at high altitude']","['portable tethered sprint running (PTSR) test under normoxic and hypoxic conditions', 'NaHCO 3  solution (n\u2009=\u20095) or water as a placebo', 'sodium bicarbonate', 'chronic sodium bicarbonate (NaHCO 3 ) ingestion', 'bicarbonate']","['blood bicarbonate concentration', 'urinary pH', 'early morning blood bicarbonate concentration', 'hypoxia-induced impairment in anaerobic, high-intensity exercise performance', 'Urinary pH and blood gas parameters', 'Blood lactate levels and blood gas parameters', 'acid-base status and anaerobic performance', 'Anaerobic high-intensity exercise performance', 'PTSR tests assessed overall peak force, mean force, and fatigue index']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C1964473', 'cui_str': 'Sojourn'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}]","[{'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",10.0,0.0991694,"However, urinary pH (p = 0.003, ηp 2  = 0.458), early morning blood bicarbonate concentration (p < 0.001, ηp 2  = 0.457) and base excess (p = 0.002, ηp 2  = 0.436) were significantly higher in the bicarbonate group compared with the control group under hypoxic conditions.
","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Limmer', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-Universität Bochum, Gesundheitscampus Nord 10, 44801, Bochum, Germany. mirjam.limmer@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'de Marées', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-Universität Bochum, Gesundheitscampus Nord 10, 44801, Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-Universität Bochum, Gesundheitscampus Nord 10, 44801, Bochum, Germany.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00351-y']
110,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


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


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


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


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
111,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


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


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


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


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
112,32295624,"CYP1A2 genotype and acute effects of caffeine on resistance exercise, jumping, and sprinting performance.","BACKGROUND


It has been suggested that polymorphisms within CYP1A2 impact inter-individual variation in the response to caffeine. The purpose of this study was to explore the acute effects of caffeine on resistance exercise, jumping, and sprinting performance in a sample of resistance-trained men, and to examine the influence of genetic variation of CYP1A2 (rs762551) on the individual variation in responses to caffeine ingestion.
METHODS


Twenty-two men were included as participants (AA homozygotes n = 13; C-allele carriers n = 9) and were tested after the ingestion of caffeine (3 mg/kg of body mass) and a placebo. Exercise performance was assessed with the following outcomes: (a) movement velocity and power output in the bench press exercise with loads of 25, 50, 75, and 90% of one-repetition maximum (1RM); (b) quality and quantity of performed repetitions in the bench press exercise performed to muscular failure with 85% 1RM; (c) vertical jump height in a countermovement jump test; and (d) power output in a Wingate test.
RESULTS


Compared to placebo, caffeine ingestion enhanced: (a) movement velocity and power output across all loads (effect size [ES]: 0.20-0.61; p <  0.05 for all); (b) the quality and quantity of performed repetitions with 85% of 1RM (ES: 0.27-0.85; p <  0.001 for all); (c) vertical jump height (ES: 0.15; p = 0.017); and (d) power output in the Wingate test (ES: 0.33-0.44; p <  0.05 for all). We did not find a significant genotype × caffeine interaction effect (p-values ranged from 0.094 to 0.994) in any of the analyzed performance outcomes.
CONCLUSIONS


Resistance-trained men may experience acute improvements in resistance exercise, jumping, and sprinting performance following the ingestion of caffeine. The comparisons of the effects of caffeine on exercise performance between individuals with the AA genotype and AC/CC genotypes found no significant differences.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry. ID: ACTRN12619000885190.",2020,"Compared to placebo, caffeine ingestion enhanced: (a) movement velocity and power output across all loads (effect size [ES]: 0.20-0.61; p <  0.05 for all); (b) the quality and quantity of performed repetitions with 85% of 1RM (ES: 0.27-0.85; p <  0.001 for all); (c) vertical jump height (ES: 0.15; p = 0.017); and (d) power output in the Wingate test (ES: 0.33-0.44; p <  0.05 for all).","['a sample of resistance-trained men', 'individuals with the AA genotype and AC/CC genotypes', 'Twenty-two men were included as participants (AA homozygotes n\xa0']","['bench press exercise performed to muscular failure with 85% 1RM; (c) vertical jump height in a countermovement jump test; and (d) power output in a Wingate test', 'caffeine', 'ID', 'placebo']","['repetition maximum (1RM); (b) quality and quantity of performed repetitions', 'exercise performance', 'Exercise performance', 'resistance exercise, jumping, and sprinting performance']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",22.0,0.235484,"Compared to placebo, caffeine ingestion enhanced: (a) movement velocity and power output across all loads (effect size [ES]: 0.20-0.61; p <  0.05 for all); (b) the quality and quantity of performed repetitions with 85% of 1RM (ES: 0.27-0.85; p <  0.001 for all); (c) vertical jump height (ES: 0.15; p = 0.017); and (d) power output in the Wingate test (ES: 0.33-0.44; p <  0.05 for all).","[{'ForeName': 'Jozo', 'Initials': 'J', 'LastName': 'Grgic', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia. jozo.grgic@live.vu.edu.au.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Pickering', 'Affiliation': 'Institute of Coaching and Performance, School of Sport and Wellbeing, University of Central Lancashire, Fylde Road, Preston, PR1 2HE, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, Lehman College, Bronx, USA.'}, {'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Mikulic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Pedisic', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00349-6']
113,1580899,Random blood salvage.,,1992,,[],[],[],[],[],[],,0.0147896,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fredin', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
114,31367901,Epicardial Application of Hydrogel with Amiodarone for Prevention of Postoperative Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting.,"The objective of this study was to assess the safety and efficacy of local epicardial application of amiodarone-releasing hydrogel for prevention of postoperative atrial fibrillation (POAF) in patients after coronary artery bypass grafting. Patients were randomized into two groups: with the application of amiodarone-releasing hydrogel and the control group. It included 60 patients (47 males, 13 females) (mean age of 62 ± 8.5). POAF incidence differences were statistically significant between two groups: in the study group, the POAF incidence was 3.3%, while in the control group, the POAF incidence was 37% (p < 0.001). Statistically significant differences were revealed in the PQ interval duration. The risk of POAF incidence was calculated using the Cox regression model: the age and the application of amiodarone-releasing hydrogel application were statistically significant. Hospital length of stay in two groups was also different (р < 0.001). The age and the application of amiodarone-releasing hydrogel were statistically significant for POAF incidence.",2020,Hospital length of stay in two groups was also different (р < 0.001).,"['60 patients (47 males, 13 females) (mean age of 62\u2009±\u20098.5', 'Patients', 'After Coronary Artery Bypass Grafting', 'patients after coronary artery bypass grafting']","['amiodarone-releasing hydrogel', 'Hydrogel with Amiodarone', 'amiodarone-releasing hydrogel and the control group']","['Postoperative Atrial Fibrillation', 'PQ interval duration', 'POAF incidence differences', 'risk of POAF incidence', 'POAF incidence', 'Hospital length of stay', 'postoperative atrial fibrillation (POAF', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.019914,Hospital length of stay in two groups was also different (р < 0.001).,"[{'ForeName': 'O L', 'Initials': 'OL', 'LastName': 'Bockeria', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Kanametov', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Shvartz', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia. vashvarts@bakulev.ru.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sokolskaya', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'D Sh', 'Initials': 'DS', 'LastName': 'Zhuginisov', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Sanakoev', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Bockeria', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}]",Journal of cardiovascular translational research,['10.1007/s12265-019-09905-1']
115,32323868,Changes in problematic activities of daily living in persons with COPD during 1 year of usual care.,"INTRODUCTION


Persons with chronic obstructive pulmonary disease (COPD) are often limited in performing their activities of daily living (ADLs). However, it remains unknown whether and to what extent problematic ADLs change over time and whether exacerbation-related hospitalisations affect problematic ADLs. Therefore, we investigated self-reported problematic ADLs of persons with COPD during 1 year of usual care (i.e. without a specific experimental intervention).
METHODS


Stable persons with moderate to very severe COPD (n = 137) were included in this longitudinal study (registered in the Dutch Trial Register [NTR 3941]). Participants were visited at home at baseline and after 1 year. Participants with an exacerbation-related hospitalisation during follow-up were visited additionally within 2 weeks after hospital discharge. During all visits, participants' personalised problematic ADLs were assessed using the Canadian Occupational Performance Measure (COPM), and perceived performance and satisfaction of important problematic ADLs were rated on a 10-point scale.
RESULTS


In total, 90% of the participants reported at least one new important problematic ADL after 1 year. In the subgroup of participants with an exacerbation-related hospitalisation (n = 31), 92% of the participants reported new problematic ADLs 2 weeks after discharge and 90% reported new problematic ADLs again after 1 year. Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
CONCLUSION


Problematic ADLs changed during 1 year of usual care, which underlines the need for regular assessment of problematic ADLs and referral to treatment options like monodisciplinary occupational therapy and/or a comprehensive pulmonary rehabilitation programme.",2020,"Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
","['persons with COPD during 1\xa0year of usual care (i.e. without a specific experimental intervention', 'Persons with chronic obstructive pulmonary disease (COPD', 'Stable persons with moderate to very severe COPD', 'n\xa0=\xa0137) were included in this longitudinal study (registered in the Dutch Trial Register [NTR 3941', 'Participants with an exacerbation-related hospitalisation during follow-up were visited additionally within 2\xa0weeks after hospital discharge', 'persons with COPD during 1 year of usual care']",[],"['Canadian Occupational Performance Measure (COPM), and perceived performance and satisfaction of important problematic ADLs', 'satisfaction score of problematic ADLs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",[],"[{'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",137.0,0.160733,"Only the satisfaction score of problematic ADLs as mentioned during baseline improved after 1-year follow-up in all participants (p = .002) and in participants without an exacerbation-related hospitalisation (n = 106; p = .014).
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Nakken', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Esther H A', 'Initials': 'EHA', 'LastName': 'van den Bogaart', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Jean W M', 'Initials': 'JWM', 'LastName': 'Muris', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Geeuwke J', 'Initials': 'GJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Sittard-Geleen, the Netherlands.'}, {'ForeName': 'Gerben P', 'Initials': 'GP', 'LastName': 'Bootsma', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Michiel H M', 'Initials': 'MHM', 'LastName': 'Gronenschild', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Jeannet M L', 'Initials': 'JML', 'LastName': 'Delbressine', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Vliet', 'Affiliation': 'Department of Respiratory Medicine, Zuyderland, Heerlen, the Netherlands.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Spruit', 'Affiliation': 'Department of Research and Development, CIRO, Horn, the Netherlands.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12664']
116,32061185,Mismatch between subjective and objective motor improvements with adapted tango intervention in older adults.,"PURPOSE


The purpose of this study was to determine the relationship between objective and subjective findings of motor function measures in older adults following a 12-week adapted tango intervention.
METHODS


A quasi-experimental repeated-measures design was used. Secondary analysis of the experimental group (Tango) data is reported here. The study took place in diverse senior independent living communities in an urban metropolitan area. Sixty-two older adults participated (n = 62, age: M = 82.3, SD = 8.8 years). Participants were assigned to 20 sessions of 90-min tango classes over 12 weeks. Motor function, depression, mental, and physical quality of life were measured before and after intervention. At post-test, satisfaction and subjective measures of motor function were assessed by participants indicating their level of agreement with statements that they improved in objective domains of motor function. Correlations were performed between subjectively rated agreement and changes in motor function, depression, and quality of life.
RESULTS


A strong negative correlation was found between subjective ratings and empirically observed improvements in balance (r = -.423) and endurance (r = -.241), although participant ratings correlated moderately with manual dual tasking (r = .319) and weakly correlated with lower body strength (r = .188). Decreased depression was correlated with subjectively improved lower body strength (r = .271) and endurance (r = .254). Improved mental quality of life was strongly (r = .423) correlated with subjectively improved balance and moderately correlated with improved manual dual tasking (r = .306).
CONCLUSION


After rehabilitation, even with improved depression and quality of life, older adults may not perceive empirically observed motor function improvements, particularly in balance and lower body strength. This study informs clinicians on the importance of assessing subjective data during rehabilitation to provide older adults with person-centred care.",2020,Decreased depression was correlated with subjectively improved lower body strength (r = .271) and endurance (r = .254).,"['diverse senior independent living communities in an urban metropolitan area', 'Sixty-two older adults participated (n = 62, age: M = 82.3, SD = 8.8\u2009years', 'older adults', 'older adults with person-centred care']",['adapted tango intervention'],"['motor function, depression, and quality of life', 'Motor function, depression, mental, and physical quality of life', 'lower body strength', 'satisfaction and subjective measures of motor function', 'depression and quality of life', 'Decreased depression', 'manual dual tasking', 'subjective ratings', 'Improved mental quality of life']","[{'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",62.0,0.0160705,Decreased depression was correlated with subjectively improved lower body strength (r = .271) and endurance (r = .254).,"[{'ForeName': 'Crystal G', 'Initials': 'CG', 'LastName': 'Bennett', 'Affiliation': 'School of Nursing, Usha Kundu MD College of Health, University of West Florida, Pensacola, FL, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Angel', 'Affiliation': 'Emory College of Arts and Sciences, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Hackney', 'Affiliation': 'Atlanta VA Center for Visual and Neurocognitive Rehabilitation, Decatur, GA, USA.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1835']
117,32189338,"Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial.","OBJECTIVE


To evaluate the efficacy and safety of pregabalin as adjunctive treatment for children (aged 1 month-<4 years) with focal onset seizures (FOS) using video-electroencephalography (V-EEG).
METHODS


This randomized, placebo-controlled, international study included V-EEG seizure monitoring (48-72 hours) at baseline and over the last 3 days of 14-day (5-day dose escalation; 9-day fixed dose) double-blind pregabalin treatment (7 or 14 mg/kg/d in three divided doses). This was followed by a double-blind 1-week taper. The primary efficacy endpoint was log-transformed seizure rate (log e  [24-hour seizure rate + 1]) for all FOS recorded during the double-blind V-EEG monitoring, evaluated in subjects who took ≥1 dose of study medication, experienced ≥1 baseline seizure(s), and had a treatment phase V-EEG. Safety and tolerability were assessed by adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms.
RESULTS


Overall, 175 patients were randomized (mean age = 28.2 months; 59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7 or 14 mg/kg/d (n = 71 or n = 34, respectively), or placebo (n = 70). Pregabalin 14 mg/kg/d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53; P = .022), an effect that was not observed with pregabalin 7 mg/kg/d (n = 59; P = .461). The most frequently reported treatment-emergent AEs for pregabalin 7 mg/kg/d, 14 mg/kg/d, and placebo, respectively, were somnolence (11.3%, 17.6%, and 5.7%) and upper respiratory tract infection (7.0%, 11.8%, and 11.4%). All AEs were mild to moderate in severity.
SIGNIFICANCE


Pregabalin 14 mg/kg/d (but not 7 mg/kg/d) significantly reduced seizure rate in children with FOS, when assessed using V-EEG, compared with placebo. Both pregabalin dosages were generally safe and well tolerated in children 1 month to <4 years of age with FOS. Safety and tolerability were consistent with the known profile of pregabalin in older children with epilepsy.",2020,d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53;,"['older children with epilepsy', 'children (aged 1\xa0month-<4\xa0years) with focal onset seizures (FOS) using video-electroencephalography (V-EEG', '59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7\xa0or 14', 'children 1 month to <4 years of age', 'children 1\xa0month to <4\xa0years of age with FOS', '175 patients were randomized (mean age = 28.2\xa0months']","['pregabalin', 'placebo', 'Pregabalin', 'Pregabalin adjunctive therapy']","['adverse events (AEs), clinical laboratory data, physical/neurological examinations, vital signs, and electrocardiograms', 'log-transformed seizure rate (log e  [24-hour seizure rate\xa0+\xa01]) for all FOS', 'seizure rate', 'focal onset seizures', 'efficacy and safety', 'somnolence', 'Safety and tolerability', 'safe and well tolerated', 'upper respiratory tract infection']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",175.0,0.619519,d (n = 28) resulted in a statistically significant 35% reduction of log e  (24-hour seizure rate + 1) versus placebo (n = 53;,"[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Jeremias', 'Initials': 'J', 'LastName': 'Antinew', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Knapp', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Almas', 'Affiliation': 'Pfizer, New York, New York.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Scavone', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Ruoyong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Pfizer Global Research and Development, Groton, Connecticut.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Modequillo', 'Affiliation': 'Department of Pediatrics, Perpetual Succour Hospital, Cebu City, Philippines.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Makedonska', 'Affiliation': ""Dnipro City Children's Clinical Hospital #5 of Dnipro City Council, Dnipro, Ukraine.""}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': ""Child Neuroscience Division, Philippine Children's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Kyrychenko', 'Affiliation': 'Department of Internal Medicine, Dnipro Medical Institute of Conventional and Alternative Medicine, Dnipro, Ukraine.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Nordli', 'Affiliation': 'Pediatric Neurology, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Farkas', 'Affiliation': 'First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Mark Kristof', 'Initials': 'MK', 'LastName': 'Farkas', 'Affiliation': 'First Department of Pediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsia,['10.1111/epi.16466']
118,32315969,"Comic book-based educational program on epilepsy for high-school students: Results from a pilot study in the Gran Chaco region, Bolivia.","INTRODUCTION


In low- and middle-income countries (LMIC), epilepsy still represents a significant health challenge. In the Bolivian Chaco, we have previously found high levels of stigma towards people with epilepsy (PWE) especially expressed by high school students. In order to increase the knowledge about epilepsy, we have tested a comic book-based intervention on a sample of high school students.
METHODS


The study has been conducted in the Bolivian Chaco region where two urban and two rural classrooms have been randomly selected. Students have been administered a knowledge, attitudes, and practices (KAP) questionnaire, and then they underwent a comic book-based educational program where they were randomly assigned either to an autonomous reading or a character interpretation methodology. The same KAP questionnaire has been administered after the teaching session and at a three months follow-up. Mean KAP scores at the baseline were compared with the after teaching and the three-month assessment.
RESULTS


Eighty-three students with a mean age of 15.5 ± 0.9 years, of whom 38 (45.8%) males, were recruited. After the comic book session, students improved in the global score (p < 0.001) and in the knowledge (p < 0.001), attitudes (p = 0.004), and practices (p < 0.001) subscores. Both the autonomous reading and the character interpretation groups significantly improved in the global score, but only the latter improved in all the subscores. At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
CONCLUSION


Using a comic book to teach about epilepsy led to a significant improvement in the knowledge, attitudes, and practices about the disease in high school students of LMIC. This teaching strategy can be easily implemented in LMIC.",2020,"At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
","['high-school students', 'Eighty-three students with a mean age of 15.5\u202f±\u202f0.9\u202fyears, of whom 38 (45.8%) males, were recruited', 'Bolivian Chaco region where two urban and two rural classrooms']","['Comic book-based educational program', 'comic book-based educational program']","['global score', 'global, knowledge, and attitudes subscores', 'Mean KAP scores']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0681446', 'cui_str': 'Comic Books'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",83.0,0.032308,"At the three months follow-up, there were no differences in the global, knowledge, and attitudes subscores, compared with scores immediately after the intervention.
","[{'ForeName': 'Calogero Edoardo', 'Initials': 'CE', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Giuliano', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Todaro', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Colli', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Padilla', 'Affiliation': 'Center of Anthropological Researches of the Teko Guaraní, Gutierrez, Bolivia.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Vilte', 'Affiliation': 'Center of Anthropological Researches of the Teko Guaraní, Gutierrez, Bolivia.'}, {'ForeName': 'Elizabeth Blanca', 'Initials': 'EB', 'LastName': 'Crespo Gómez', 'Affiliation': 'Hospital Universitario Hernández Vera, Santa Cruz, Bolivia.'}, {'ForeName': 'Walter Mario', 'Initials': 'WM', 'LastName': 'Camargo Villarreal', 'Affiliation': 'Bolivian League Against Epilepsy, Santa Cruz, Bolivia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bartoloni', 'Affiliation': 'Department of Experimental and Clinical Medicine, Infectious and Tropical Diseases Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nicoletti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy. Electronic address: anicolet@unict.it.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107076']
119,32270959,Infra-Abdominal Muscles Activation Brings Benefits to the Pulmonary Function of Patients with Sternal Instability after Cardiac Surgery.,"OBJECTIVE


To compare physical therapy strategies involving abdominal muscle stabilization, with and without upper limb movement, in patients with sternal instability after heart surgery and during in-hospital care.
METHODS


This prospective, longitudinal, randomized, and comparative clinical study included 20 patients, which were divided into two groups: ARM, the arm group (n=10), and LEG, the leg group (n=10). The study involved the evaluation of scores of visual analog scales for sternal instability, pain, discomfort, functional impairment, lung function, and maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) before and after the interventions. Two protocols consisting of abdominal exercises in both groups with upper limb movements (ARM) and just abdominal activation with leg movements (LEG) were used for three weeks.
RESULTS


There were statistically significant (P≤0.01) improvements in pain, discomfort, and functional impairment scores, and in MIP (P=0.04) and MEP (P≤0.01) after intervention in both groups and just LEG showed improvement in forced vital capacity (P=0.043) and forced expiratory volume in one second (P=0.011).
CONCLUSION


Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures. Perhaps they were influenced by the time and resolution of the infection process, although exercises with upper limb movements seem to be safe in this population. The activation of the infra-abdominal muscles through leg movements seems to bring more benefits to lung function.",2020,"Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures.","['20 patients', 'Patients with Sternal Instability after Cardiac Surgery', 'patients with sternal instability after heart surgery and during in-hospital care']","['abdominal exercises', 'just abdominal activation with leg movements (LEG']","['forced vital capacity', 'pain, discomfort, and functional impairment scores, and in MIP', 'forced expiratory volume', 'values of inspiratory and expiratory pressures', 'pain, discomfort, and functional impairment scores', 'visual analog scales for sternal instability, pain, discomfort, functional impairment, lung function, and maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0454354', 'cui_str': 'Abdominal exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}]",20.0,0.0210973,"Both strategies promoted improvement in pain, discomfort, and functional impairment scores and in the values of inspiratory and expiratory pressures.","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Nozawa', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiane Domingues', 'Initials': 'CD', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Patricia Oliva de', 'Initials': 'PO', 'LastName': 'Almeida', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Critical Patients of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Filomena Regina Gomes', 'Initials': 'FRG', 'LastName': 'Galas', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Anesthesia and Surgical Intensive Care of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Ignêz Zanetti', 'Initials': 'MIZ', 'LastName': 'Feltrim', 'Affiliation': 'Universidade de São Paulo Faculdade de Medicina Hospital das Clínicas São Paulo SP Brazil Department of Physiotherapy of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor/HC-FMUSP), São Paulo, SP, Brazil.'}]",Brazilian journal of cardiovascular surgery,['10.21470/1678-9741-2018-0365']
120,31506808,Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse.,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair.
METHODS


Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires.
RESULTS


Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%).
CONCLUSION


Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.",2020,"Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004).","['147 women originally included, 75 (51%) were successfully re-contacted a median of 7\xa0years after the initial surgery', 'multicenter study conducted between April 2005 and December 2009 comparing', 'anterior vaginal wall prolapse']","['anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France', 'trans-obturator vaginal mesh with native tissue repair', 'TVM', 'transvaginal mesh (TVM) or native tissue repair']","['subjective recurrence of prolapse', 'functional recurrence rate', 'Anatomical recurrence', 'Mesh exposure rates', 'anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires', 'surgical reintervention', 'anatomical recurrence', 'pain or dyspareunia', 'Mesh exposure']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse (disorder)'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy (procedure)'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}]",147.0,0.138094,"Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004).","[{'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Allègre', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France.'}, {'ForeName': 'Geertje', 'Initials': 'G', 'LastName': 'Callewaert', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France. geertje.callewaert@chu-nimes.fr.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Alonso', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, University of Montpellier, Nîmes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Cornille', 'Affiliation': 'Department of Obstetrics and Gynecology, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Fernandez', 'Affiliation': 'Department of Obstetrics and Gynecology, Kremin Bicêtre Hospital, Kremin Bicêtre, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Eglin', 'Affiliation': 'Department of Obstetrics and Gynecology, Clinique Champeau, Béziers, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'de Tayrac', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France.'}]",International urogynecology journal,['10.1007/s00192-019-04073-x']
121,31553833,Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis.,"BACKGROUND


The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.
METHODS


We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore >1 [range, 0 to 3] on any of the four Mayo scale components).
RESULTS


The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P<0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P<0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.
CONCLUSIONS


Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).",2019,The incidence of serious adverse events with ustekinumab was similar to that with placebo.,"['patients with moderate-to-severe ulcerative colitis', '825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received', 'Ulcerative Colitis', 'A total of 961 patients', 'patients with ulcerative colitis', 'Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab']","['intravenous induction dose of ustekinumab', 'subcutaneous maintenance injections of 90 mg of ustekinumab', 'Ustekinumab', 'placebo', 'intravenous ustekinumab', 'ustekinumab', 'weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo']","['clinical remission', 'severe disease', 'incidence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0153594', 'cui_str': 'Cancer of Testis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",961.0,0.501503,The incidence of serious adverse events with ustekinumab was similar to that with placebo.,"[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Jewel', 'Initials': 'J', 'LastName': 'Johanns', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Van Assche', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Targan', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Szapary', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900750']
122,31410518,TVT-O vs. TVT-Abbrevo for stress urinary incontinence treatment in women: a randomized trial.,"INTRODUCTION


To compare the efficacy, safety and complications of the trans-obturator midurethral sling from inside to outside (TVT-O) and of the shorter trans-obturator midurethral sling (TVT-Abbrevo) for treatment of female SUI.
MATERIALS AND METHODS


One hundred fifty-eight recruited patients were randomized into either the TVT-O or TVT-Abbrevo group. Preoperative assessment included history and general assessment, urinalysis and urine culture, urogynaecological clinical examination, urodynamic evaluation and urogynaecologic interview by ICIQ-SF-UI, PGI-I and PISQ12. Operative time, perioperative complications, spontaneous voiding, postoperative complications and hospital stay were prospectively recorded in all patients. At 3, 6, 12, 24 and 36 months after surgery, patients were asked to answer urogynaecological interviews by ICIQ-SF-UI, PGI-I and PISQ12. The urodynamic assessment was performed at 12, 24 and 36 months. Success rate was assessed at 12, 24 and 36 months postoperatively.
RESULTS


Overall, 138 of 158 patients (87%) were cured of SUI 36 months after the operation with no significant differences between groups [69 (87%) and 69 (87%) patients in the TVT-O and TVT Abbrevo groups, respectively]. The two groups did not significantly differ in operative time, intraoperative blood loss and length of hospital stay. Nine patients (11%) had postoperative groin pain in the TVT-O group and one patient in the TVT Abbrevo group (p = 0.02). Three-year control demonstrated an equal objective cure rate in both groups. There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU.
CONCLUSION


TVT-Abbrevo has similar efficacy and safety compared with TVT-O in women with SUI; the use of a shorter sling reduces postoperative pain.",2020,"There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU.
","['women with SUI', 'female SUI', 'One hundred fifty-eight recruited patients', 'stress urinary incontinence treatment in women']","['TVT-O', 'trans-obturator midurethral sling from inside to outside (TVT-O) and of the shorter trans-obturator midurethral sling (TVT-Abbrevo', 'TVT-O vs. TVT-Abbrevo', 'TVT-O or TVT-Abbrevo group']","['Success rate', 'postoperative pain', 'efficacy, safety and complications', 'history and general assessment, urinalysis and urine culture, urogynaecological clinical examination, urodynamic evaluation and urogynaecologic interview by ICIQ-SF-UI, PGI-I and PISQ12', 'objective cure rate', 'total PISQ-12 and ICIQ-SF-UI scores', 'operative time, intraoperative blood loss and length of hospital stay', 'postoperative groin pain', 'Operative time, perioperative complications, spontaneous voiding, postoperative complications and hospital stay']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0588388', 'cui_str': 'General observation (regime/therapy)'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain (finding)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",158.0,0.0478452,"There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU.
","[{'ForeName': 'Marzio Angelo', 'Initials': 'MA', 'LastName': 'Zullo', 'Affiliation': 'Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy.'}, {'ForeName': 'Michele Carlo', 'Initials': 'MC', 'LastName': 'Schiavi', 'Affiliation': 'Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome ""Sapienza"", Umberto I Hospital, Viale del Policlinico 155, 00161, Rome, Italy. michelecarlo.schiavi@gmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Luffarelli', 'Affiliation': 'Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Prata', 'Affiliation': 'Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome ""Sapienza"", Umberto I Hospital, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Di Pinto', 'Affiliation': 'Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome ""Sapienza"", Umberto I Hospital, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Oliva', 'Affiliation': 'Department of Gynecological and Obstetric, San Filippo Neri Hospital, Rome, Italy.'}]",International urogynecology journal,['10.1007/s00192-019-04077-7']
123,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


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


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


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


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


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
124,32321767,Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial.,"OBJECTIVE


The CIRCE trial (NCT01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study.
METHODS


Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors.
RESULTS


A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms.
CONCLUSION


After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.",2020,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","['Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire', 'locally advanced cervical cancer (stages IIB-IVA', '107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm', 'Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment', 'locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial']","['neoadjuvant chemotherapy', 'neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation']","['Quality of life', 'sexual/vaginal functioning', 'Quality of life compliance rates', 'menopausal symptoms scale', 'quality of life questionnaire', 'mean quality of life scales', 'body image and menopausal symptoms scale', 'worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'sexual enjoyment, peripheral neuropathy, and menopausal symptoms', 'quality of life', 'lymphedema (p<0.001) and sexual worry', 'efficacy, safety, and quality of life']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424403', 'cui_str': 'Erotic feeling'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",107.0,0.0959925,"Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01).","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Nunes de Arruda', 'Affiliation': 'Sao Paulo University Faculty of Medicine, Sao Paulo, Brazil fernanda.arruda@fm.usp.br.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'da Costa', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Bonadio', 'Affiliation': 'Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Abraão', 'Initials': 'A', 'LastName': 'Dornellas', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pereira', 'Affiliation': 'Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'Epidemiology, University of Groningen Faculty of Medical Sciences, Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Pilar Estevez Diz', 'Affiliation': 'Radiology and Oncology, Universidade de Sao Paulo Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Sao Paulo, Brazil.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001134']
125,32320844,Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.,"INTRODUCTION


Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.
INTERVENTION


This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.
METHODS


This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.
CONCLUSION


This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
TRIAL REGISTRATION


Clinical Trials.gov: NCT03255967.",2020,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[""Persons living with Alzheimer's disease and related dementias (ADRD"", '345 persons living with ADRD and their informal caregiver dyads', 'persons living with dementia and their informal caregivers']","['Aliviado Dementia Care', 'Aliviado Dementia Care program or usual care']","['caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization', 'person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use', 'quality of life (QOL', 'quality of life', 'QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.117164,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[{'ForeName': 'Alycia A', 'Initials': 'AA', 'LastName': 'Bristol', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Convery', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sotelo', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Schneider', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Shih-Yin', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Rupper', 'Affiliation': 'University of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'Comprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106005']
126,32320846,Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial.,"BACKGROUND


A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months.
METHODS


A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle.
DISCUSSION


The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020.",2020,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","['persons at risk of hospital admission', ""Participants' experiences""]","[""intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare"", 'Proactive health support (PaHS) - telephone-based self-management support']","['Cost-effectiveness', 'mental health composite score of the SF-36v2 questionnaire', 'Quality of life', 'hospital admissions and improve quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.110494,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","[{'ForeName': 'Kirstine Skov', 'Initials': 'KS', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark. Electronic address: kra@regionsjaelland.dk.'}, {'ForeName': 'Camilla Palmhøj', 'Initials': 'CP', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: camilla.palmhoj@rm.dk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hjarnaa', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: louise.hjarnaa@regionh.dk.'}, {'ForeName': 'Maja Kjær', 'Initials': 'MK', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: maja.kjaer.rasmussen@rsyd.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kidholm', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: kristian.kidholm@rsyd.dk.'}, {'ForeName': 'Berit Kjærside', 'Initials': 'BK', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: beritnie@rm.dk.'}, {'ForeName': 'Nina Konstantin', 'Initials': 'NK', 'LastName': 'Nissen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: niniss@rm.dk.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Fredens', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: mia.fredens@rm.dk.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark. Electronic address: susanne.winther@rn.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Grønkjær', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: mette.groenkjaer@rn.dk.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: ulla.toft@regionh.dk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106004']
127,32319528,"Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff.","INTRODUCTION


The single-dose pharmacokinetics (PK) of a novel, non-tobacco-based nicotine pouch, ZYN, 3 and 6 mg, were compared with 8 mg General snus (part 1) and ZYN 8 mg was compared with 18 mg Longhorn moist snuff (part 2). The present study demonstrates the characteristics of three strengths of a novel tobacco-free oral snus, ZYN, viz. the extraction of nicotine from the oral cavity and its uptake into the systemic blood circulation. Comparison is made to Swedish General snus and American Longhorn moist snuff and from literature 4 mg Nicorette gum and mean of 13 brands of e-cigarettes.
AIMS AND METHODS


A single-dose randomized crossover design was used. In vivo extraction and PK parameters were determined.
RESULTS


Part 1. The AUCinf of ZYN 3 mg was 27% smaller than that of 8 mg General and the AUCinf of ZYN 6 mg was 34% larger than that of 8 mg General. Less nicotine was extracted from ZYN 3 mg (1.5 mg) and more from ZYN 6 mg (3.5 mg) than from 8 mg General (2.4 mg). The extracted fractions of nicotine for both ZYN products (56% and 59%) were significantly larger than for 8 mg General (32%).
RESULTS


Part 2. Close to identical plasma nicotine curves, AUCinf and Cmax were found for ZYN 8 mg and Longhorn Natural 18 mg moist snuff. The extracted amount of nicotine from ZYN 8 mg (3.8 mg) was larger than the amount extracted from Longhorn Natural 18 mg (3.0 mg), but smaller than the extracted amount of nicotine from General 2 × 8 mg snus pouches (5.0 mg). The extracted fraction of nicotine for ZYN 8 mg (50%) was larger than for Longhorn Natural (19%) and General 2 × 8 mg snus pouches (33%).
CONCLUSIONS


The two higher doses of ZYN (6 and 8 mg) deliver nicotine as quickly and to a similar extent as existing smokeless products, with no significant adverse effects.",2020,"Close to identical plasma nicotine curves, AUCinf and Cmax were found for ZYN® 8 mg and Longhorn Natural 18 mg moist snuff.",[],"['novel tobacco-free oral snus, ZYN®, viz', 'novel, non-tobacco-based nicotine pouch, ZYN®, 3 and 6 mg, were compared to 8 mg General snus (Part 1) and ZYN® 8 mg was compared to 18 mg Longhorn moist snuff (Part 2', 'nicotine', 'novel non-tobacco-based nicotine pouch (ZYN®) with conventional, tobacco-based Swedish snus and American moist snuff']",[],[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4288198', 'cui_str': 'Snus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}]",[],,0.0159261,"Close to identical plasma nicotine curves, AUCinf and Cmax were found for ZYN® 8 mg and Longhorn Natural 18 mg moist snuff.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lunell', 'Affiliation': 'Department of Clinical Pharmacology, CROEL AB, Helsingborg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Fagerström', 'Affiliation': 'Department of Psychology, University of Uppsala, Vaxholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'Department of Psychiatry, University of Vermont, UHC Campus, Burlington, VT.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pendrill', 'Affiliation': 'Product Science, Swedish Match, Stockholm, Sweden.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa068']
128,32318831,The efficacy of different cleaning protocols for the sealer-contaminated access cavity.,"OBJECTIVES


Sealer remnants in the access cavity may negatively affect coronal seal and cause tooth discoloration. This study sought to evaluate the efficacy of different cleaning protocols for the sealer-contaminated access cavity.
MATERIALS AND METHODS


Sixty extracted human molars were accessed, chemomechanically prepared and warm vertically obturated with gutta-percha and epoxy resin sealer. Teeth were randomly assigned to one control (air/water spray) and five test groups (n = 10): scrubbing with an ethanol-saturated cotton pellet (CP), scrubbing with an ethanol-saturated microbrush (MB), air polishing (ProphyFlex, KaVo), MB + air polishing and cleaning with a round bur. Each tooth was split sagittally, and the sealer-covered access cavity area (SCA) before and after cleaning was determined using image analysis software and compared pre- and post-operatively and across groups using paired samples t test and one-way ANOVA.
RESULTS


The SCA was significantly reduced in all test groups (P < 0.05), but not in the control group (P > 0.05). Highest epoxy resin sealer reductions were observed for MB (92%) and MB + air polishing (94%), yielding a significantly better SCA reduction than that of ethanol-saturated cotton pellet (58%), bur cleaning (69%) or air polishing alone (64%).
CONCLUSIONS


All cleaning protocols except air/water spray reduced the amount of epoxy resin sealer in the access cavity, but none of them completely removed the sealer. Cleaning with the ethanol-saturated microbrush, with or without air polishing, performed better than the other methods.
CLINICAL RELEVANCE


Scrubbing with an ethanol-saturated microbrush, with or without air polishing, was the most efficient method for cleaning the epoxy resin sealer-contaminated molar access cavity.",2020,"Cleaning with the ethanol-saturated microbrush, with or without air polishing, performed better than the other methods.
","['Sixty extracted human molars were accessed, chemomechanically prepared and warm vertically obturated with gutta-percha and epoxy resin sealer']","['ethanol-saturated microbrush, with or without air polishing', 'Cleaning with the ethanol-saturated microbrush, with or without air polishing', 'ethanol-saturated cotton pellet', 'ethanol-saturated cotton pellet (CP), scrubbing with an ethanol-saturated microbrush (MB), air polishing (ProphyFlex, KaVo), MB + air polishing and cleaning with a round bur']","['SCA reduction', 'SCA']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0441436', 'cui_str': 'Pellet gun missile'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",60.0,0.023452,"Cleaning with the ethanol-saturated microbrush, with or without air polishing, performed better than the other methods.
","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Devroey', 'Affiliation': 'Department of Oral Health Sciences, Section of Endodontology, Ghent University, C. Heymanslaan 10/P8, B, 9000, Ghent, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Calberson', 'Affiliation': 'Department of Oral Health Sciences, Section of Endodontology, Ghent University, C. Heymanslaan 10/P8, B, 9000, Ghent, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Meire', 'Affiliation': 'Department of Oral Health Sciences, Section of Endodontology, Ghent University, C. Heymanslaan 10/P8, B, 9000, Ghent, Belgium. Maarten.Meire@ugent.be.'}]",Clinical oral investigations,['10.1007/s00784-020-03283-8']
129,32319087,The effect of rocuronium on ventilatory leak and sealing pressure using a supraglottic airway device: A randomized clinical trial.,"BACKGROUND


The transition of ventilatory leak and sealing pressure in supraglottic airway devices after administration of neuromuscular blocking agents is unclear. We hypothesized that ventilatory leak would decrease due to the increase in sealing pressure after administration of 0.15 and 0.30 mg/kg rocuronium iv.
METHODS


Forty patients were randomly assigned to a control group or one of two rocuronium groups. After induction of general anaesthesia, an i-gel ®  was inserted before rocuronium administration. The ventilatory leak and sealing pressure were measured immediately. Then, 0.15 mg/kg or 0.30 mg/kg rocuronium iv was administered and the ventilatory leak and sealing pressure were measured again. In the control group, measurements were obtained just after insertion of the supraglottic airway device and 5 minutes later, without any additional drug administration.
RESULTS


Similar decrements in ventilatory leak of approximately 3% were registered in all three groups. There were no changes in sealing pressure in any of the groups. However, multiple logistic regression analysis demonstrated that the reduced height of the first twitch response to train-of-four stimulation after administration of rocuronium was a determinant of a decrease in sealing pressure (odds ratio: 0.97, 95% confidence interval: 0.95-0.99, P = .04).
CONCLUSIONS


Our results suggest that ventilatory leak with a supraglottic airway device decreases independently of neuromuscular blockade, although the neuromuscular blockade may potentially decrease sealing pressure. Registration of Clinical trials: UMIN Clinical Trials Registry (registration ID: UMIN000027061, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031018).",2020,There were no changes in sealing pressure in any of the groups.,['Forty patients'],['rocuronium'],"['sealing pressure', 'ventilatory leak', 'ventilatory leak and sealing pressure', 'sealing pressure (odds ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",40.0,0.193245,There were no changes in sealing pressure in any of the groups.,"[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Anesthesiology, Nishinihon Hospital, Kumamoto-City, Kumamoto, Japan.'}, {'ForeName': 'Fumiyo', 'Initials': 'F', 'LastName': 'Kubota', 'Affiliation': 'Department of Anesthesiology, Nishinihon Hospital, Kumamoto-City, Kumamoto, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesiology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto University Hospital, Kumamoto-City, Kumamoto, Japan.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13608']
130,32319154,Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.,"AIMS


To evaluate the cost-effectiveness of a specialist smoking cessation package for people with severe mental illness DESIGN: Incremental cost-effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12-month time horizon. Total costs, including smoking cessation, health-care and social services costs and quality-adjusted life years (QALYs), derived from the five-level EuroQol 5-dimension (EQ-5D-5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty.
SETTING


Sixteen primary care and 21 secondary care mental health sites in England.
PARTICIPANTS


Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526).
INTERVENTION AND COMPARATOR


A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group.
MEASUREMENTS


BSC intervention cost was estimated from the treatment log. Costs of UC, health-care and social services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates.
FINDINGS


The mean total cost in the BSC group was £270 [95% confidence interval (CI) = -£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = -0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost-effective at £20 000/QALY).
CONCLUSIONS


A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.",2020,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"['Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n=526', 'Sixteen primary care and 21 secondary care mental health sites in England PARTICIPANTS', 'people with severe mental illness', 'people with severe mental illness in England', 'participants who were randomised, 261 were in UC group and 265 were in BSC group']","['BSC) package', 'mental health smoking cessation practitioner versus usual care (UC', 'bespoke smoking cessation package', 'AND COMPARATOR\n\n\nA bespoke smoking cessation', 'standard smoking cessation services', 'specialist smoking cessation package']","['BSC intervention cost', 'mean total cost', 'cost-effectiveness', 'Incremental costs and incremental QLAYs', 'Cost-effectiveness', 'Total costs, including smoking cessation, healthcare and social services costs, and quality-adjusted life years (QALYs), derived from EQ-5D-5L', 'Costs of UC, healthcare and social services, and EQ-5D-5L']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.132121,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"[{'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Addiction (Abingdon, England)",['10.1111/add.15086']
131,32217498,Improving Self-Care in Patients With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing: Randomized Controlled Trial.,"BACKGROUND


Technological surrogate nursing (TSN) derives from the idea that nurse-caregiver substitutes can be created by technology to support chronic disease self-care.
OBJECTIVE


This paper begins by arguing that TSN is a useful and viable approach to chronic disease self-care. The analysis then focuses on the empirical research question of testing and demonstrating the effectiveness and safety of prototype TSN supplied to patients with the typical complex chronic disease of coexisting type 2 diabetes and hypertension. At the policy level, it is shown that the data allow for a calibration of TSN technology augmentation, which can be readily applied to health care management.
METHODS


A 24-week, parallel-group, randomized controlled trial (RCT) was designed and implemented among diabetic and hypertensive outpatients in two Hong Kong public hospitals. Participants were randomly assigned to an intervention group, supplied with a tablet-based TSN app prototype, or to a conventional self-managing control group. Primary indices-hemoglobin A 1c , systolic blood pressure, and diastolic blood pressure-and secondary indices were measured at baseline and at 8, 12, 16, and 24 weeks after initiation, after which the data were applied to test TSN effectiveness and safety.
RESULTS


A total of 299 participating patients were randomized to the intervention group (n=151) or the control group (n=148). Statistically significant outcomes that directly indicated TSN effectiveness in terms of hemoglobin  1c  were found in both groups but not with regard to systolic and diastolic blood pressure. These findings also offered indirect empirical support for TSN safety. Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation. Statistically significant changes in secondary indices were obtained in one or both groups, but not between the groups.
CONCLUSIONS


The RCT's strong behavioral basis, as well as the importance of safety and effectiveness when complex chronic illness is proximately self-managed by layperson patients, prompted the formulation of the empirical joint hypothesis that TSN would improve patient self-care while satisfying the condition of patient self-safety. Statistical and decision analysis applied to the experimental outcomes offered support for this hypothesis. Policy relevance of the research is demonstrated by the derivation of a data-grounded operational calibration of TSN technology augmentation with ready application to health care management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02799953; https://clinicaltrials.gov/ct2/show/NCT02799953.",2020,Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation.,"['diabetic and hypertensive outpatients in two Hong Kong public hospitals', 'With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing', 'patients with the typical complex chronic disease of coexisting type 2 diabetes and hypertension', '299 participating patients', 'Patients']","['TSN', 'intervention group, supplied with a tablet-based TSN app prototype, or to a conventional self-managing control group', 'prototype TSN']","['TSN effectiveness', 'TSN effectiveness and safety', 'Primary indices-hemoglobin A 1c , systolic blood pressure, and diastolic blood pressure-and secondary indices', 'systolic and diastolic blood pressure']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",299.0,0.0459725,Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation.,"[{'ForeName': 'Calvin Kalun', 'Initials': 'CK', 'LastName': 'Or', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Mike K P', 'Initials': 'MKP', 'LastName': 'So', 'Affiliation': 'Department of Information Systems, Business Statistics, and Operations Management, Hong Kong University of Science and Technology, Hong Kong, Hong Kong.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Loretta Y C', 'Initials': 'LYC', 'LastName': 'Yam', 'Affiliation': 'Ambulatory Diabetes Centre, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tiwari', 'Affiliation': 'School of Nursing, Hong Kong Sanatorium and Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Yuen Fun Emmy', 'Initials': 'YFE', 'LastName': 'Lau', 'Affiliation': 'Ambulatory Diabetes Centre, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lau', 'Affiliation': 'Ambulatory Diabetes Centre, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Pui Sze Grace', 'Initials': 'PSG', 'LastName': 'Hui', 'Affiliation': 'Diabetes Mellitus Centre, Tung Wah Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Hop Chun', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Diabetes Mellitus Centre, Tung Wah Eastern Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'DeGroote School of Business, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michael Tow', 'Initials': 'MT', 'LastName': 'Cheung', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, University of Hong Kong, Hong Kong, Hong Kong.'}]",Journal of medical Internet research,['10.2196/16769']
132,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND


Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce.
OBJECTIVE


To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters.
METHOD


A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues.
RESULTS


For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important.
CONCLUSION


A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162']
133,32270474,"Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial.","BACKGROUND


Management of moderate-to-severe post-operative pain after elective caesarean section (ECS) is internationally primarily based on either epidural catheters or opioids. However, both techniques are associated with some undesirable adverse events. Bilateral transmuscular quadratus lumborum (TQL) block has proven to reduce opioid consumption significantly in the first 24 post-operative hours following ECS and prolong time to first opioid (TFO) (Hansen CKD, Steingrimsdottir M, Laier GE, et al. Reg Anesth Pain Med. 2019; 10.1136/rapm-2019-100540). We present a randomised controlled trial aiming to investigate whether continuous analgesia via bilateral TQL catheters can prolong TFO after ECS.
METHODS


This study is a double-blind, randomised, placebo-controlled trial. Patients should be 18 years or older and scheduled for ECS under spinal anaesthesia to be included. Main exclusion criteria are inability to cooperate, excessive daily intake of opioids and difficult ultrasound visualisation of muscular and fascial structures. Participants are randomised to receive ultrasound-guided injection of either 30 mL ropivacaine 0.2% bilaterally and an elastomeric pump containing 0.2% ropivacaine, or 30 mL saline bilaterally and an elastomeric pump containing saline, 2 hours after catheter placement. The primary endpoint is TFO. Secondary outcomes include pain intensity on a numeric rating scale (NRS), accumulated morphine consumption during 24 hours, displacement frequency of catheters and morphine-related adverse events.
RECRUITMENT PERIOD


Four patients were included from September 2018 to November 2018. Inclusion was resumed in June 2019 and will continue until 24 patients with useful data have been included in the trial. Expected inclusion period is 10-14 months.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03663478. EudraCT: 2017-003625-15.",2020,Bilateral transmuscular quadratus lumborum (TQL) block has proven to reduce opioid consumption significantly in the first 24 postoperative hours following ECS and prolong time to first opioid (TFO).,"['Patients should be 18 years or older and scheduled for ECS under spinal anaesthesia to be included', 'PERIOD\n\n\nFour patients were included from September 2018 - November 2018', 'elective caesarean section', '24 patients with useful data have been included in the trial', 'moderate to severe postoperative pain after elective caesarean section (ECS']","['Bilateral transmuscular quadratus lumborum (TQL) block', 'placebo', 'continuous analgesia via bilateral TQL catheters', 'ultrasound-guided injection of either 30 ml ropivacaine 0.2% bilaterally and an elastomeric pump containing 0.2% ropivacaine, or 30 ml saline bilaterally and an elastomeric pump containing saline', 'Ultrasound-guided transmuscular quadratus lumborum catheters']","['pain intensity on a numeric rating scale (NRS), accumulated morphine consumption during 24 hours, displacement frequency of catheters and morphine-related adverse events', 'TFO', 'opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",4.0,0.736749,Bilateral transmuscular quadratus lumborum (TQL) block has proven to reduce opioid consumption significantly in the first 24 postoperative hours following ECS and prolong time to first opioid (TFO).,"[{'ForeName': 'Guðný E', 'Initials': 'GE', 'LastName': 'Steingrímsdóttir', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Hansen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Børglum', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13601']
134,32291222,"Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel syndrome: a multicentre randomised trial.","QUESTION


In people with carpal tunnel syndrome who are waitlisted for surgical consultation, does a therapist-led care pathway involving education, splinting and exercises reduce the need for surgery and improve patient outcomes?
DESIGN


A multicentre, randomised controlled trial with concealed allocation, blinded assessment and intention-to-treat analysis.
PARTICIPANTS


One hundred and five people with electrodiagnostically confirmed carpal tunnel syndrome on a waitlist for surgical consultation and recruited from four public hospitals in Australia.
INTERVENTIONS


The experimental group (n = 52) received a one-off group session of education, splinting, and nerve and tendon gliding exercises. The control group (n = 53) continued on the waitlist without additional care.
OUTCOME MEASURES


The primary outcome measures were conversion to surgery by 24 weeks, the global rating of change (GROC) scale and patient satisfaction. Secondary outcomes included symptom severity and functional limitation.
RESULTS


At 24 weeks, conversion to surgery was 59% in the experimental group and 80% in the control group (risk difference -0.21, 95% CI -0.38 to -0.03). More participants in the experimental group identified as improved at 6 weeks (20% vs 4%; risk difference 0.15, 95% CI 0.03 to 0.28) but not at 24 weeks (24% vs 10%; risk difference 0.14, 95% CI -0.01 to 0.29). The intervention was also estimated to be beneficial on some measures of satisfaction, symptom severity and functional limitation. The study's estimates of the benefits came with some uncertainty, which makes it unclear whether the wider population of people awaiting carpal tunnel surgery would consider that the benefits make the intervention worthwhile. No serious adverse effects were reported.
CONCLUSIONS


A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation.
REGISTRATION


ACTRN12613001095752.",2020,"A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation.
","['people with carpal tunnel syndrome who are waitlisted for surgical consultation', 'One hundred and five people with electrodiagnostically confirmed carpal tunnel syndrome on a waitlist for surgical consultation and recruited from four public hospitals in Australia']","['one-off group session of education, splinting, and nerve and tendon gliding exercises', 'night splinting and home exercises reduce conversion to surgery', 'waitlist without additional care']","['symptom severity and functional limitation', 'satisfaction, symptom severity and functional limitation', 'conversion to surgery by 24 weeks, the global rating of change (GROC) scale and patient satisfaction', 'serious adverse effects', 'conversion to surgery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556894', 'cui_str': 'Night splinting'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",105.0,0.157446,"A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation.
","[{'ForeName': 'Karina J', 'Initials': 'KJ', 'LastName': 'Lewis', 'Affiliation': 'Occupational Therapy Department, Gold Coast University Hospital, Gold Coast, Australia; School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Coppieters', 'Affiliation': 'The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Brisbane and Gold Coast, Australia; Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Allied Health Department, Queen Elizabeth II Jubilee Hospital, Brisbane, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hughes', 'Affiliation': 'Gold Coast University Hospital, Southport, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Annina B', 'Initials': 'AB', 'LastName': 'Schmid', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom. Electronic address: annina.schmid@neuro-research.ch.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.03.007']
135,31821187,"Relationship Between Duration of Targeted Temperature Management, Ischemic Interval, and Good Functional Outcome From Out-of-Hospital Cardiac Arrest.","OBJECTIVES


Tailoring hypothermia duration to ischemia duration may improve outcome from out-of-hospital cardiac arrest. We investigated the association between the hypothermia/ischemia ratio and functional outcome in a secondary analysis of data from the Resuscitation Outcomes Consortium Amiodarone, Lidocaine, or Placebo Study trial.
DESIGN


Cohort study of out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium-Amiodarone, Lidocaine, or Placebo Study.
SETTING


Multicenter study across North America.
PATIENTS


Adult, nontraumatic, out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium-Amiodarone, Lidocaine, or Placebo Study who survived to hospital admission and received targeted temperature management between May 2012 and October 2015.
INTERVENTIONS


Targeted temperature management in comatose survivors of out-of-hospital cardiac arrest. We defined hypothermia/ischemia ratio as total targeted temperature management time (initiation through rewarming) divided by calculated total ischemia time (approximate time of arrest [9-1-1 call or emergency medical services-witnessed] to return of spontaneous circulation).
MEASUREMENTS AND MAIN RESULTS


The primary outcome was hospital survival with good functional status (modified Rankin Score, 0-3) at hospital discharge. We fitted logistic regression models to estimate the association between hypothermia/ischemia ratio and the primary outcome, adjusting for demographics, arrest characteristics, and Resuscitation Outcomes Consortium enrolling site. A total of 3,429 patients were eligible for inclusion, of whom 36.2% were discharged with good functional outcome. Patients had a mean age of 62.0 years (SD, 15.8), with 69.7% male, and 58.0% receiving lay-rescuer cardiopulmonary resuscitation. Median time to return of spontaneous circulation was 21.1 minutes (interquartile range, 16.1-26.9), and median duration of targeted temperature management was 32.9 hours (interquartile range, 23.7-37.8). A total of 2,579 had complete data and were included in adjusted regression analyses. After adjustment for patient characteristics and Resuscitation Outcomes Consortium site, a greater hypothermia/ischemia ratio was associated with increased survival with good functional outcome (odds ratio, 2.01; 95% CI, 1.82-2.23). This relationship, however, appears to be primarily driven by time to return of spontaneous circulation in this patient cohort.
CONCLUSIONS


Although a larger hypothermia/ischemia ratio was associated with good functional outcome after out-of-hospital cardiac arrest in this cohort, this association is primarily driven by duration of time to return of spontaneous circulation. Tailoring duration of targeted temperature management based on duration of time to return of spontaneous circulation or patient characteristics requires prospective study.",2020,"Although a larger hypothermia/ischemia ratio was associated with good functional outcome after out-of-hospital cardiac arrest in this cohort, this association is primarily driven by duration of time to return of spontaneous circulation.","['Study who survived to hospital admission and received targeted temperature management between May 2012 and October 2015', 'Multicenter study across North America', 'Patients had a mean age of 62.0 years (SD, 15.8), with 69.7% male, and 58.0% receiving lay-rescuer cardiopulmonary resuscitation', 'Cohort study of out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium', 'comatose survivors of out-of-hospital cardiac arrest', '3,429 patients were eligible for inclusion, of whom 36.2% were discharged with good functional outcome', 'Adult, nontraumatic, out-of-hospital cardiac arrest patients screened for Resuscitation Outcomes Consortium']","['Amiodarone, Lidocaine, or Placebo']","['hypothermia/ischemia ratio', 'median duration of targeted temperature management', 'survival with good functional outcome', 'Median time to return of spontaneous circulation', 'hospital survival with good functional status (modified Rankin Score, 0-3) at hospital discharge']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",3429.0,0.0466598,"Although a larger hypothermia/ischemia ratio was associated with good functional outcome after out-of-hospital cardiac arrest in this cohort, this association is primarily driven by duration of time to return of spontaneous circulation.","[{'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Sawyer', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Humbert', 'Affiliation': 'Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Leroux', 'Affiliation': 'Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': 'Departments of Emergency Medicine and Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Department of Emergency Medicine, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Grunau', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Ornato', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Rittenberger', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Wittwer', 'Affiliation': 'Department of Emergency Medicine, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'Clark County Emergency Medical Service, Vancouver, WA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Egan', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Richmond', 'Affiliation': 'Medstar Mobile Healthcare, Metropolitan Area EMS Authority, Fort Worth, TX.'}, {'ForeName': 'Veer D', 'Initials': 'VD', 'LastName': 'Vithalani', 'Affiliation': 'Medstar Mobile Healthcare, Metropolitan Area EMS Authority, Fort Worth, TX.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Scales', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baker', 'Affiliation': 'Department of Anesthesia, Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kurz', 'Affiliation': 'Department of Emergency Medicine, University of Alabama School of Medicine, Birmingham, AL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004160']
136,31015560,Positive verbal suggestion optimizes postural control.,"Balance is a very important function that allows maintaining a stable stance needed for many daily life activities and for preventing falls. We investigated whether balance control could be improved by a placebo procedure consisting of verbal suggestion. Thirty healthy volunteers were randomized in two groups (placebo and control) and asked to perform a single-leg stance task in which they had to stand as steadily as possible on the dominant leg. The task was repeated in three sessions (T0, T1, T2). At T1 and T2 an inert treatment was applied on the leg, by informing the placebo group that it was effective in improving balance. The control group was overtly told that treatment was inert. An accelerometer applied on participants' leg allowed to measure body sways in different directions. Subjective parameters, like perception of stability, were also collected. Results showed that the placebo group had less body sways than the control group at T2, both in the three-dimensional space and in the anterior-posterior direction. Furthermore, the placebo group perceived to be more stable than the control group. This study represents the first evidence that placebo effect optimizes posture, with a potential translational impact in patients with postural and gait disturbances.",2019,"Results showed that the placebo group had less body sways than the control group at T2, both in the three-dimensional space and in the anterior-posterior direction.","['Thirty healthy volunteers', 'patients with postural and gait disturbances']","['placebo and control) and asked to perform a single-leg stance task', 'placebo']","['Subjective parameters, like perception of stability', 'body sways']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0575081', 'cui_str': 'Gait difficulty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",30.0,0.0501398,"Results showed that the placebo group had less body sways than the control group at T2, both in the three-dimensional space and in the anterior-posterior direction.","[{'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Villa-Sánchez', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Menegaldo', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tinazzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy. mirta.fiorio@univr.it.'}]",Scientific reports,['10.1038/s41598-019-42888-2']
137,31403552,Cold Pulsatile Machine Perfusion Versus Static Cold Storage for Kidneys Donated After Circulatory Death: A Multicenter Randomized Controlled Trial.,"BACKGROUND


The benefits of cold pulsatile machine perfusion (MP) for the storage and transportation of kidneys donated after circulatory death are disputed. We conducted a UK-based multicenter, randomized controlled trial to compare outcomes of kidneys stored with MP versus static cold storage (CS).
METHODS


Fifty-one pairs of kidneys donated after circulatory death were randomly allocated to receive static CS or cold pulsatile MP. The primary endpoint, delayed graft function, was analyzed by ""intention-to-treat"" evaluation.
RESULTS


There was no difference in the incidence of delayed graft function between CS and MP (32/51 (62.8%) and 30/51 (58.8%) P = 0.69, respectively), although the trial stopped early due to difficulty with recruitment. There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups. Median estimated glomerular filtration rate at 3 months following transplantation was significantly lower in the CS group compared with MP (CS 34 mL/min IQR 26-44 vs MP 45 mL/min IQR 36-60, P = 0.006), although there was no significant difference in estimated glomerular filtration rate between CS and MP at 12 months posttransplant.
CONCLUSIONS


This study is underpowered, which limits definitive conclusions about the use of MP, as an alternative to static CS. It did not demonstrate that the use of MP reduces the incidence of delayed graft function in donation after circulatory death kidney transplantation.",2020,"There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups.","['donation after circulatory death kidney transplantation', '51 pairs of DCD donor kidneys', 'kidneys donated after circulatory death']","['Cold pulsatile machine perfusion versus static cold storage', 'kidneys stored with machine perfusion (MP) versus static cold storage (CS', 'cold pulsatile machine perfusion', 'static cold storage or cold pulsatile machine perfusion', 'machine perfusion']","[""intention-to-treat' evaluation"", 'incidence of DGF', 'delayed graft function (DGF', 'incidence of acute rejection, or in graft or patient survival', 'Median eGFR', 'eGFR']","[{'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0608070', 'cui_str': 'dicarboxydine'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",51.0,0.35985,"There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups.","[{'ForeName': 'Dominic M', 'Initials': 'DM', 'LastName': 'Summers', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Niaz', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Transplantation, Leeds University Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Lucy V', 'Initials': 'LV', 'LastName': 'Randle', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Johnson', 'Affiliation': 'Statistics and Clinical Studies Department, Organ Donation and Transplantation NHSBT, Bristol, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Collett', 'Affiliation': 'Statistics and Clinical Studies Department, Organ Donation and Transplantation NHSBT, Bristol, United Kingdom.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Attia', 'Affiliation': 'Department of Transplantation, Leeds University Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clancy', 'Affiliation': 'Department of Transplantation, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Tavakoli', 'Affiliation': 'Department of Transplantation, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Department of Transplantation, Edinburgh University, Edinburgh, United Kingdom.'}, {'ForeName': 'Neville V', 'Initials': 'NV', 'LastName': 'Jamieson', 'Affiliation': 'Department of Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Bradley', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'J E Watson', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002907']
138,31577671,Randomized Sirolimus-based Early Calcineurin Inhibitor Reduction in Liver Transplantation: Impact on Renal Function.,"BACKGROUND


The long-term use of calcineurin inhibitors (CNIs) after liver transplantation (LT) is associated with nephrotoxicity.
METHODS


Five-year follow-up data were retrieved from the randomized controlled multicenter SiLVER trial. Standard CNI-based mammalian target of rapamycin-free immunosuppression (group A, n = 264) was compared with a 50% reduction of CNI and introduction of the mammalian target of rapamycin inhibitor Sirolimus (SIR) within 4-6 weeks after LT (group B, n = 261).
RESULTS


Median MELD at LT was low with 10 (7-15) (group A) and 11 (8-15) (group B) in the intention-to-treat approach. CNI dose and CNI trough were reduced by 20% and 8% (group A) versus 55% and 56% (group B) at 3 months posttransplantation. Renal function was preserved at 3 months after LT in the SIR arm (estimated glomerular filtration rate 74 [57-95] versus 67 [55-85] mL/min/1.73m2 P = 0.004) but was similarly impaired thereafter compared with group A. The per protocol analysis identified LT recipients in group B with concomitant early CNI minimization and SIR treatment ≥ year 1 with significantly superior estimated glomerular filtration rate and lowest rate of chronic kidney disease (≥stage 3) from year 1 onwards until study end. Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder, and hyperglycemia) were not associated with worse kidney function.
CONCLUSIONS


Prevention of CNI nephrotoxicity by SIR-based early CNI minimization protects renal function only short-term after LT in the intention-to-treat analysis of this low MELD cohort. Yet, selected LT recipients compliant with early CNI minimization and SIR maintenance achieved better long-term renal outcomes compared with real-world practice.",2020,"Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia) were not associated with worse kidney function.
","['5-year follow-up data', 'liver transplantation']","['Standard CNI-based mTOR-free immunosuppression', 'calcineurin inhibitors (CNI) after liver transplantation (LT', 'Sirolimus-based early calcineurin inhibitor reduction', 'mTOR inhibitor Sirolimus', 'Sirolimus-based early CNI minimization']","['Renal function', 'CNI dose and CNI trough', 'renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.102055,"Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia) were not associated with worse kidney function.
","[{'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Buchholz', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Ferguson', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital, Goethe-University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Institute of Translational Medicine (ITM), University Hospitals Birmingham NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Darius F', 'Initials': 'DF', 'LastName': 'Mirza', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000002980']
139,32320006,Nicotinamide riboside supplementation alters body composition and skeletal muscle acetylcarnitine concentrations in healthy obese humans.,"BACKGROUND


Nicotinamide riboside (NR) is an NAD+ precursor that boosts cellular NAD+ concentrations. Preclinical studies have shown profound metabolic health effects after NR supplementation.
OBJECTIVES


We aimed to investigate the effects of 6 wk NR supplementation on insulin sensitivity, mitochondrial function, and other metabolic health parameters in overweight and obese volunteers.
METHODS


A randomized, double-blinded, placebo-controlled, crossover intervention study was conducted in 13 healthy overweight or obese men and women. Participants received 6 wk NR (1000 mg/d) and placebo supplementation, followed by broad metabolic phenotyping, including hyperinsulinemic-euglycemic clamps, magnetic resonance spectroscopy, muscle biopsies, and assessment of ex vivo mitochondrial function and in vivo energy metabolism.
RESULTS


Markers of increased NAD+ synthesis-nicotinic acid adenine dinucleotide and methyl nicotinamide-were elevated in skeletal muscle after NR compared with placebo. NR increased body fat-free mass (62.65% ± 2.49% compared with 61.32% ± 2.58% in NR and placebo, respectively; change: 1.34% ± 0.50%, P = 0.02) and increased sleeping metabolic rate. Interestingly, acetylcarnitine concentrations in skeletal muscle were increased upon NR (4558 ± 749 compared with 3025 ± 316 pmol/mg dry weight in NR and placebo, respectively; change: 1533 ± 683 pmol/mg dry weight, P = 0.04) and the capacity to form acetylcarnitine upon exercise was higher in NR than in placebo (2.99 ± 0.30 compared with 2.40 ± 0.33 mmol/kg wet weight; change: 0.53 ± 0.21 mmol/kg wet weight, P = 0.01). However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
CONCLUSIONS


NR supplementation of 1000 mg/d for 6 wk in healthy overweight or obese men and women increased skeletal muscle NAD+ metabolites, affected skeletal muscle acetylcarnitine metabolism, and induced minor changes in body composition and sleeping metabolic rate. However, no other metabolic health effects were observed.This trial was registered at clinicaltrials.gov as NCT02835664.",2020,"However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
","['overweight and obese volunteers', 'healthy obese humans', '13 healthy overweight or obese men and women', 'healthy overweight or obese men']","['placebo supplementation, followed by broad metabolic phenotyping, including hyperinsulinemic-euglycemic clamps, magnetic resonance spectroscopy, muscle biopsies, and assessment of ex vivo mitochondrial function and in vivo energy metabolism', 'placebo', '6 wk NR supplementation', 'Nicotinamide riboside supplementation']","['NAD+ synthesis-nicotinic acid adenine dinucleotide and methyl nicotinamide', 'insulin sensitivity, mitochondrial function, and other metabolic health parameters', 'body composition and sleeping metabolic rate', 'insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism', 'body fat-free mass', 'sleeping metabolic rate', 'metabolic health effects', 'capacity to form acetylcarnitine upon exercise', 'skeletal muscle NAD+ metabolites', 'acetylcarnitine concentrations in skeletal muscle']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}]","[{'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0068723', 'cui_str': 'nicotinic acid adenine dinucleotide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0232174', 'cui_str': 'Cardiac ejection fraction'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",13.0,0.485712,"However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
","[{'ForeName': 'Carlijn M E', 'Initials': 'CME', 'LastName': 'Remie', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Kay H M', 'Initials': 'KHM', 'LastName': 'Roumans', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Michiel P B', 'Initials': 'MPB', 'LastName': 'Moonen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Niels J', 'Initials': 'NJ', 'LastName': 'Connell', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Mevenkamp', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lindeboom', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Vera H W', 'Initials': 'VHW', 'LastName': 'de Wit', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Suzanne A B M', 'Initials': 'SABM', 'LastName': 'Aarts', 'Affiliation': 'Department of Medical Biochemistry, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lutgens', 'Affiliation': 'Department of Medical Biochemistry, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bauke V', 'Initials': 'BV', 'LastName': 'Schomakers', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hyung L', 'Initials': 'HL', 'LastName': 'Elfrink', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Zapata-Pérez', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Riekelt H', 'Initials': 'RH', 'LastName': 'Houtkooper', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Auwerx', 'Affiliation': 'Laboratory of Integrative and Systems Physiology, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa072']
140,32315648,Validity and Responsiveness of Floor Sitting-Rising Test in Post-Total Knee Arthroplasty: A Cohort Study.,"OBJECTIVES


To assess the construct validity and responsiveness of the floor sitting-rising test (SRT) in individuals with total knee arthroplasty (TKA).
DESIGN


Cohort study with 6-month follow-up. Secondary analysis using data from a randomized controlled trial.
SETTING


An outpatient rehabilitation research center.
PARTICIPANTS


Participants (N=240) enrolled in the parent study who had unilateral primary TKA.
INTERVENTION


Participants in the parent study underwent 12 weeks of exercise programs.
MAIN OUTCOME MEASURES


Validity analysis correlated baseline data of participants who completed the SRT and measures of knee motion, muscle strength, performance-based tests, and patient-reported outcomes of physical and psychosocial function. Responsiveness analysis used the 3- and 6-month follow-up data. Effect sizes were calculated using changes from baseline. Areas under the receiving operating characteristics curve were calculated using a global rating of change as the external anchor.
RESULTS


Of the 240 participants (148 women; age, 70±7y), 180 (75%) were able to perform the SRT at baseline. Performers scored significantly better in all physical function tests (P<.0001) than nonperformers. SRT scores generally converged with measures of knee impairment and performance-based tests (associations ranged from small [r=0.15; P=.0516] to moderate [r=0.52; P<.0001]). SRT scores associated with self-efficacy for function (r=0.34; P<.0001) and fear of falls (r=-0.25; P=.001). At 3 (n=174) and 6 months (n=160), SRT effect sizes were 0.38 (95% confidence interval, 0.25-0.52) and 0.42 (95% confidence interval, 0.25-0.60), and areas under the curve were 0.59 (95% confidence interval, 0.49-0.69) and 0.62 (95% confidence interval, 0.52-0.73), respectively.
CONCLUSIONS


The results add evidence to the validity of the SRT in patients after TKA. The strength of the associations suggests that the SRT measures a physical function construct not captured by the other tests. The magnitude of indices of responsiveness for the SRT were similar to other performance-based tests, indicating comparable responsiveness to more widespread tests of functional performance.",2020,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"['All 240 participants enrolled in the parent study who had unilateral primary TKA', '240 participants (148 female, age 70±7SD years), 180 (75', 'Post-Total Knee Arthroplasty', 'Outpatient rehabilitation research center', 'individuals with total knee arthroplasty (TKA']","['exercise programs', 'floor sitting-rising test (SRT']","['fear of falls', 'SRT effect sizes', 'SRT scores', 'Validity and responsiveness of floor Sitting-Rising Test', 'knee motion, muscle strength, performance-based tests, and patient-reported outcomes (PROs) of physical and psychosocial function']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",240.0,0.113594,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"[{'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Alomar', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Maria Beatriz C', 'Initials': 'MBC', 'LastName': 'Catelani', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clair N', 'Initials': 'CN', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Patterson', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Artman', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA. Electronic address: spiva@pitt.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.012']
141,31015587,Levodopa does not affect expression of reinforcement learning in older adults.,"Dopamine has been implicated in learning from rewards and punishment, and in the expression of this learning. However, many studies do not fully separate retrieval and decision mechanisms from learning and consolidation. Here, we investigated the effects of levodopa (dopamine precursor) on choice performance (isolated from learning or consolidation). We gave 31 healthy older adults 150 mg of levodopa or placebo (double-blinded, randomised) 1 hour before testing them on stimuli they had learned the value of the previous day. We found that levodopa did not affect the overall accuracy of choices, nor the relative expression of positively or negatively reinforced values. This contradicts several studies and suggests that overall dopamine levels may not play a role in the choice performance for values learned through reinforcement learning in older adults.",2019,"We found that levodopa did not affect the overall accuracy of choices, nor the relative expression of positively or negatively reinforced values.","['31 healthy older adults 150\u2009mg of', 'older adults']","['Dopamine', 'levodopa or placebo', 'levodopa', 'levodopa (dopamine precursor', 'Levodopa']",['reinforcement learning'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035007', 'cui_str': 'Reinforcement'}]",31.0,0.213707,"We found that levodopa did not affect the overall accuracy of choices, nor the relative expression of positively or negatively reinforced values.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Grogan', 'Affiliation': 'University of Bristol, Bristol, UK. john.grogan@bristol.ac.uk.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Isotalus', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Howat', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Irigoras Izagirre', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Knight', 'Affiliation': 'University Hospitals Bristol, Bristol, UK.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Coulthard', 'Affiliation': 'University of Bristol, Bristol, UK. Elizabeth.coulthard@bristol.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-42904-5']
142,32316824,Sexual Activity and Substance Use Among Adolescents and Young Adults Receiving Cancer Treatment: A Report from the PRISM Randomized Controlled Trial.,"Purpose:  Despite health implications, sexual activity and substance use among adolescents and young adults (AYAs) receiving cancer treatment are understudied.  Methods:  AYAs 12-25 years of age participated in a randomized controlled trial testing the efficacy of a resilience intervention. They were fluent in English and either diagnosed with new cancer (NC) or advanced cancer (AC). At baseline and 6 months, participants self-reported sexual activity and substance use. We describe the percentage of AYAs who endorsed each behavior and a count of total behaviors endorsed by each respondent. We describe frequencies by sex/gender (male/female), age (<18/≥18), and disease status (AC/NC).  Results:  Participants ( N  = 92) were majority white/Caucasian (57%), 12-17 years old (73%), and diagnosed with leukemia/lymphoma (62%); 32% had AC. Responses were not associated with the intervention; hence, we summarized data from the whole cohort. At both time points, median behavior endorsed was 2. At baseline and follow-up, 87% and 81% endorsed at least 1 behavior: 13% and 15% were sexually active, 75% and 73% of whom used birth control inconsistently; and 22% and 22% reported drinking alcohol, 31% and 27% using prescription opioids/sedatives, 19% and 22% using other drugs, and 9% and 7% using tobacco. Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  Conclusion:  AYAs engage in sexual activity and substance use during cancer treatment.",2020,"Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  ","['Receiving Cancer Treatment', 'adolescents and young adults (AYAs) receiving cancer treatment are understudied', 'Adolescents and Young Adults', 'They were fluent in English and either diagnosed with new cancer (NC) or advanced cancer (AC', '12-25 years of age participated', 'Results:  Participants ( N \u2009=\u200992) were majority white/Caucasian (57%), 12-17 years old (73%), and diagnosed with leukemia/lymphoma (62%); 32% had AC', 'sex/gender (male/female), age (<18/≥18), and disease status (AC/NC']",['resilience intervention'],"['Sexual Activity and Substance Use', 'drinking alcohol', 'sexual activity', 'sexual activity and substance use']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043157', 'cui_str': 'Caucasian'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",92.0,0.0804546,"Young adults engaged in most behaviors more frequently than adolescents (e.g., 48% vs. 12% alcohol at baseline); males engaged in sexual activity more frequently than females (e.g., 20% vs. 5% sexually active at baseline); and AYAs with NC engaged in most behaviors more frequently than those with AC (18% vs. 0% sexually active at baseline).  ","[{'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Fladeboe', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Tyler G', 'Initials': 'TG', 'LastName': 'Ketterl', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington, USA.""}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2020.0001']
143,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


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


Prospective crossover physiologic study.
SETTING


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


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


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


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


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
144,32293471,Effects of post exercise protein supplementation on markers of bone turnover in adolescent swimmers.,"BACKGROUND


This study examined the effects of whey protein supplementation, compared with an isocaloric carbohydrate beverage and water, consumed immediately following an intense swimming trial on bone turnover in adolescent swimmers.
METHODS


Fifty-eight (31 female, 27 male) swimmers (14.1 ± 0.4 years) were stratified into three groups matched for age, sex and body mass. The protein and carbohydrate groups consumed two isocaloric post-exercise beverages each containing 0.3 g . kg - 1  of whey protein (with ~ 6 mg of calcium) or maltodextrin while the control group consumed water. Participants provided a morning, fasted, resting blood sample, then performed an intense swimming trial consisting of a maximal 200 m swim followed by a high intensity interval swimming protocol (5x100m, 5x50m and 5x25m; 1:1 work-to-rest ratio). Following swimming, they consumed their first respective post-exercise beverage, and 2 h later, they performed a second maximal swim immediately followed by the second beverage. Approximately 3 h after the second beverage, two post-consumption blood samples were collected at 8 h and 24 h from baseline. Procollagen type 1 intact N-terminal propeptide (PINP) and carboxy-terminal collagen crosslinks (CTXI) were measured in serum. The multiples of medians of PINP and CTXI were also used to calculate bone turnover rate and balance.
RESULTS


No significant changes were observed in PINP. CTXI increased (+ 11%) at 8 h in all groups, but then significantly decreased (- 22%) at 24 h in the protein group only. The protein group also had a significantly higher calculated rate of bone turnover at 8 h and 24 h compared to baseline, which was not observed in the other groups.
CONCLUSIONS


These results shed light on the potential importance of protein consumed shortly after intense swimming in promoting positive bone turnover responses up to 24 h following exercise in adolescent athletes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov PRS; NCT04114045. Registered 1 October 2019 - Retrospectively registered.",2020,"The protein group also had a significantly higher calculated rate of bone turnover at 8 h and 24 h compared to baseline, which was not observed in the other groups.
","['31 female, 27 male) swimmers (14.1\u2009±\u20090.4\u2009years', 'Fifty-eight', 'adolescent swimmers', 'adolescent athletes']","['post exercise protein supplementation', 'maximal 200\u2009m swim followed by a high intensity interval swimming protocol', 'whey protein (with ~\u20096\u2009mg of calcium) or maltodextrin', 'whey protein supplementation']","['PINP', 'calculated rate of bone turnover', 'CTXI', 'Procollagen type 1 intact N-terminal propeptide (PINP) and carboxy-terminal collagen crosslinks (CTXI', 'markers of bone turnover', 'bone turnover rate and balance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0231544', 'cui_str': 'Bone turnover rate'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0387894,"The protein group also had a significantly higher calculated rate of bone turnover at 8 h and 24 h compared to baseline, which was not observed in the other groups.
","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Theocharidis', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, Ontario, L2S 3A1, Canada.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'McKinlay', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, Ontario, L2S 3A1, Canada.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vlachopoulos', 'Affiliation': ""Children's Health and Exercise Research Centre, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.""}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Faculty of Health, School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, Ontario, L2S 3A1, Canada.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, Ontario, L2S 3A1, Canada. nklentrou@brocku.ca.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00350-z']
145,32294318,Appointment reminders to increase uptake of HIV retesting by at-risk individuals: a randomized controlled study in Thailand.,"INTRODUCTION


Frequent HIV testing of at-risk individuals is crucial to detect and treat infections early and prevent transmissions. We assessed the effect of reminders on HIV retesting uptake.
METHODS


The study was conducted within a programme involving four facilities providing free-of-charge HIV, syphilis and hepatitis B and C testing and counselling in northern Thailand. Individuals found HIV negative and identified at risk by counsellors were invited to participate in a three-arm, open-label, randomized, controlled trial comparing: (a) ""No Appointment & No Reminder"" (control arm); (b) ""No Appointment but Reminder"": short message service (SMS) sent 24 weeks after the enrolment visit to remind booking an appointment, and sent again one week later if no appointment was booked; and (c) ""Appointment & Reminder"": appointment scheduled during the enrolment visit and SMS sent one week before appointment to ask for confirmation; if no response: single call made within one business day. The primary endpoint was a HIV retest within seven months after the enrolment visit. The cost of each reminder strategy was calculated as the sum of the following costs in United States dollars (USD): time spent by participants, counsellors and hotline staff; phone calls made; and SMS sent. The target sample size was 217 participants per arm (651 overall).
RESULTS


Between April and November 2017, 651 participants were randomized. The proportion presenting for HIV retesting within seven months was 11.2% (24/215) in the control arm, versus 19.3% (42/218) in ""No Appointment but Reminder"" (p = 0.023) and 36.7% (80/218) in ""Appointment & Reminder"" (p < 0.001). Differences in proportions compared to the control arm were respectively +8.1% (95% CI: +1.4% to +14.8%) and +25.5% (+17.9% to +33.2%). The incremental cost-effectiveness ratios of ""No Appointment but Reminder"" and ""Appointment & Reminder"" compared to the control arm were respectively USD 0.05 and USD 0.14 per participant for each 5% increase in HIV retesting uptake within seven months.
CONCLUSIONS


Scheduling an appointment and sending a reminder one week before was a simple, easy-to-implement and affordable intervention that significantly increased HIV retesting uptake in these at-risk individuals. The personal phone call to clients probably contributed, and also improved service efficiency.",2020,"The incremental cost-effectiveness ratios of ""No Appointment but Reminder"" and ""Appointment & Reminder"" compared to the control arm were respectively USD 0.05 and USD 0.14 per participant for each 5% increase in HIV retesting uptake within seven months.
","['651 participants were randomized', 'four facilities providing free-of-charge HIV, syphilis and hepatitis B and C testing and counselling in northern Thailand', 'Between April and November 2017', '217 participants per arm (651 overall']",[],"['HIV retesting uptake', 'proportion presenting for HIV retesting', 'uptake of HIV retesting', 'cost of each reminder strategy', 'incremental cost-effectiveness ratios', 'HIV retest']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}]",651.0,0.0859365,"The incremental cost-effectiveness ratios of ""No Appointment but Reminder"" and ""Appointment & Reminder"" compared to the control arm were respectively USD 0.05 and USD 0.14 per participant for each 5% increase in HIV retesting uptake within seven months.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Salvadori', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Adam', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mary', 'Affiliation': 'INSERM U1153, Team ECSTRA, Université Paris Diderot - Paris 7, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Decker', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Sabin', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': 'INSERM U1153, Team ECSTRA, Université Paris Diderot - Paris 7, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Surachet', 'Initials': 'S', 'LastName': 'Arunothong', 'Affiliation': 'Department of Disease Control, Ministry of Public Health, Chiang Mai, Thailand.'}, {'ForeName': 'Woottichai', 'Initials': 'W', 'LastName': 'Khamduang', 'Affiliation': 'Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Prapan', 'Initials': 'P', 'LastName': 'Luangsook', 'Affiliation': 'Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Visitsak', 'Initials': 'V', 'LastName': 'Suksa-Ardphasu', 'Affiliation': 'Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jullapong', 'Initials': 'J', 'LastName': 'Achalapong', 'Affiliation': 'Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': 'Laboratoire de Virologie - EA 3620, Université Paris Descartes, Hôpital Necker, Paris, France.'}, {'ForeName': 'Wasna', 'Initials': 'W', 'LastName': 'Sirirungsi', 'Affiliation': 'Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ngo-Giang-Huong', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}, {'ForeName': 'Gonzague', 'Initials': 'G', 'LastName': 'Jourdain', 'Affiliation': 'Institut de recherche pour le développement (IRD)-PHPT, Marseille, France.'}]",Journal of the International AIDS Society,['10.1002/jia2.25478']
146,32277868,Switching protease inhibitors to rilpivirine in HIV-positive individuals with complete viral suppression and without prior HIV drug resistance in a resource-limited setting: a randomized controlled trial.,"INTRODUCTION


Prior to the availability of rilpivirine (RPV), patients who could not tolerate efavirenz and nevirapine (NVP) were treated with protease inhibitor (PI)-based antiretroviral therapy (ART). Dyslipidaemia and other metabolic complications are commonly associated with PI use. This study aimed to compare the efficacy and adverse events between switching from PI-based to RPV-based regimen, versus continuing PI-based regimens in HIV-positive individuals with complete viral suppression.
METHODS


A randomized controlled trial was conducted in HIV-positive individuals receiving PI-based regimens with undetectable HIV RNA and without prior HIV drug resistance. Patients were enrolled between July and December 2017 in a university medical centre in Bangkok, Thailand. They were randomized to switch from PIs to RPV (switch group) or continue ritonavir-boosted PI (control group). Primary endpoint was the proportion of patients with undetectable HIV RNA at 48 weeks. Changes in CD4 cell counts, lipid profiles and adverse events were also analysed.
RESULTS AND DISCUSSION


A total of 84 patients were enrolled, 42 in each group. Mean age was 47.7 years and 53.6% were males. At 48 weeks, 95.2% of patients in the switch group and 92.9% of control group had maintained undetectable HIV RNA (difference rate 2.4%; 95% CI, -9.6 to 14.7). Means of CD4 cell counts were 611 and 641 cells/mm 3  in switch and control groups respectively (p = 0.632). Mean changes in lipid profiles (switch vs. control groups) were: total cholesterol, -12.5 versus + 12.2 (p = 0.024); LDL, -3.4 versus + 6.2 (p = 0.040); HDL, +1.6 versus + 1.9 (p = 0.887); and triglycerides, -82.6 versus - 24.4 mg/dL (p = 0.031). The mean changes of glucose and eGFR were similar (p > 0.05) between the two groups. The mean change of ALT was significantly greater in switch group (18.2 vs. 4.0 U/L, p = 0.017). One patient in switch group had anorexia and elevated ALT at 14 weeks and completely recovered after RPV discontinuation.
CONCLUSIONS


Switching PIs to RPV, in patients with complete viral suppression and without prior HIV drug resistance, sustains viral suppression and yields better lipid profiles. This finding supports its use as switching therapy in patients receiving PI-based regimens due to intolerance to efavirenz and NVP and previous alternatives limited to PI in resource-limited settings.",2020,"The mean change of ALT was significantly greater in switch group (18.2 vs. 4.0 U/L,","['Patients were enrolled between July and December 2017 in a university medical centre in Bangkok, Thailand', 'Mean age was 47.7\xa0years and 53.6% were males', 'HIV-positive individuals with complete viral suppression', '84 patients were enrolled, 42 in each group', 'patients receiving PI-based regimens due to intolerance to', 'HIV-positive individuals with complete viral suppression and without prior HIV drug resistance in a resource-limited setting', 'HIV-positive individuals receiving PI-based regimens with undetectable HIV RNA and without prior HIV drug resistance']","['protease inhibitor (PI)-based antiretroviral therapy (ART', 'efavirenz and NVP', 'rilpivirine (RPV', 'rilpivirine', 'efavirenz and nevirapine (NVP', 'RPV (switch group) or continue ritonavir-boosted PI (control group']","['total cholesterol', 'efficacy and adverse events', 'Mean changes in lipid profiles', 'mean change of ALT', 'Dyslipidaemia and other metabolic complications', 'CD4 cell counts, lipid profiles and adverse events', 'proportion of patients with undetectable HIV RNA', 'maintained undetectable HIV RNA', 'mean changes of glucose and eGFR', 'anorexia and elevated ALT', 'CD4 cell counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}]",84.0,0.0529765,"The mean change of ALT was significantly greater in switch group (18.2 vs. 4.0 U/L,","[{'ForeName': 'Kulissara', 'Initials': 'K', 'LastName': 'Palanuphap', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Somnuek', 'Initials': 'S', 'LastName': 'Sungkanuparph', 'Affiliation': 'Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand.'}]",Journal of the International AIDS Society,['10.1002/jia2.25462']
147,32040523,The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial.,"BACKGROUND


The rapid scale-up of HIV therapy across Africa has failed to adequately engage adolescents living with HIV (ALWHIV). Retention and viral suppression for this group (ALWHIV) is 50% lower than for adults. Indeed, on the African continent, HIV remains the single leading cause of mortality among adolescents. Strategies tailored to the unqiue developmental and social vulnerabilities of this group are urgently needed to enhance successful treatment.
METHODS


We carried out a five-year longitudinal cluster randomized trial (ClinicalTrials.gov ID: NCT01790373) with adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics to test the effect of a family economic empowerment (EE) intervention on viral suppression in five districuts in Uganda. In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial. We used data from 288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics). The primary end point was undetectable plasma HIV RNA levels, defined as < 40 copies/ml. We used Kaplan-Meier (KM) analysis and Cox proportional hazard models to estimate intervention effects.
FINDINGS


The Kaplan-Meier (KM) analysis indicated that an incidence of undetectable VL (0.254) was significantly higher in the intervention condition compared to 0.173 (in non-intervention arm) translated into incidence rate ratio of 1.468 (CI: 1.064-2.038), p = 0.008. Cox regression results showed that along with the family-based EE intervention (adj. HR = 1.446, CI: 1.073-1.949, p = 0.015), higher number of medications per day had significant positive effects on the viral suppression (adj.HR = 1.852, CI: 1.275-2.690, p = 0.001).
INTERPRETATION


A family economic empowerment intervention improved treatment success for ALWHIV in Uganda. Analyses of cost effectiveness and scalability are needed to advance incorporation of this intervention into routine practice in low and middle-income countries.",2020,"HR = 1.852, CI: 1.275-2.690, p = 0.001).
","['adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics', '288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics', 'In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial', 'adolescents living with HIV in southern Uganda']","['family based economic empowerment intervention (Suubi+Adherence', 'family economic empowerment (EE) intervention']","['Retention and viral suppression', 'viral suppression', 'suppression of HIV viral loads', 'undetectable plasma HIV RNA levels']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",288.0,0.0770241,"HR = 1.852, CI: 1.275-2.690, p = 0.001).
","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University School of Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Darejan', 'Initials': 'D', 'LastName': 'Dvalishvili', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies at Columbia University Medical Center, The City of New York, NY, United States of America.'}, {'ForeName': 'Elvin H', 'Initials': 'EH', 'LastName': 'Geng', 'Affiliation': 'Division of Infectious Diseases, John T. Milliken Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Fredderick', 'Initials': 'F', 'LastName': 'Makumbi', 'Affiliation': 'School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), Department of Medicine, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Mukasa', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}]",PloS one,['10.1371/journal.pone.0228370']
148,32044276,Hózhó: Promoting sleep health among Navajo caregivers.,"OBJECTIVES


This study explored the feasibility and acceptability of a sleep health education intervention for caregivers of children with developmental disabilities (DD).
DESIGN


This mixed-methods pilot study utilized repeated measures and caregiver interviews.
SETTING


The intervention occurred in the homes of caregivers who live on the Navajo Nation.
PARTICIPANTS


Fifteen caregivers of children with DD aged from birth to 3 years old participated.
INTERVENTION


The intervention consisted of three 1-hour home-based sessions. Educational modules were tailored to specific sleep issues of the caregiver and their child(ren), as well as the unique environmental and cultural features of Navajo families.
MEASUREMENTS


Quantitative measures included a sleep habits questionnaire, pre- and postmeasures of learning, and the SF-12 HRQoL. Quantitative data were analyzed with frequencies and repeated measures analyses with p .05. Qualitative comments regarding facilitators and detractors to healthy sleep were transcribed verbatim and categorized into themes.
RESULTS


Caregiver sleep duration increased by 2 hours (5.8±1.8 to 7.8±1.9, p = .005). Caregivers also reported improved physical (45.0±8.2 to 52.8+8.7 p = .001) and mental HR-QoL (41.8±8.9 to 49.3±10.9, p = .002), and enhanced knowledge of sleep disorders (13.4±4.0 to 20.7±5.6) and healthy sleep habits (15.7±4.1 to 25.4±3.4 each p = .005). Many participants reported better sleep quality in their children with earlier bedtimes and less night waking.
CONCLUSIONS


Findings suggest that this tailored sleep education program is a culturally responsive approach to promoting caregiver sleep health and HR-QoL, as well as the sleep health of their children. Caregivers credited improved sleep to the support they received during visits and text messaging.",2020,"Caregivers also reported improved physical (45.0±8.2 to 52.8+8.7 p = .001) and mental HR-QoL (41.8±8.9 to 49.3±10.9, p = .002), and enhanced knowledge of sleep disorders (13.4±4.0 to 20.7±5.6) and healthy sleep habits (","['caregivers of children with developmental disabilities (DD', 'Navajo caregivers', 'homes of caregivers who live on the Navajo Nation', 'Fifteen caregivers of children with DD aged from birth to 3 years old participated']",['sleep health education intervention'],"['mental HR-QoL', 'healthy sleep habits', 'Caregiver sleep duration', 'sleep habits questionnaire, pre- and postmeasures of learning, and the SF-12 HRQoL. Quantitative data', 'enhanced knowledge of sleep disorders', 'sleep quality', 'sleep health', 'physical']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018701'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",15.0,0.019263,"Caregivers also reported improved physical (45.0±8.2 to 52.8+8.7 p = .001) and mental HR-QoL (41.8±8.9 to 49.3±10.9, p = .002), and enhanced knowledge of sleep disorders (13.4±4.0 to 20.7±5.6) and healthy sleep habits (","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'Institute for Human Development, Northern Arizona University, PO Box 5630, Flagstaff, AZ 86011, USA. Electronic address: Maureen.russell@nau.edu.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Baldwin', 'Affiliation': 'Center for World Health, College of Nursing and Health Innovation, Arizona State University, 500 North 3(rd) St., Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': 'College of Medicine, University of Arizona, PO Box 245017, Tucson, AZ, 85724, USA; Division of Sleep Medicine, Harvard Medical School, Suite BL-438, 221 Longwood Avenue, Boston, MA 02115, USA.'}]",Sleep health,['10.1016/j.sleh.2019.12.008']
149,32081767,"Calories, Caffeine and the Onset of Obesity in Young Children.","OBJECTIVE


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


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


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


Caffeine was a marker for increased intake of calories and decreased intake of key nutrients. When discussing dietary intake in early childhood, practitioners should screen for nutrient deficiency in young children and recommend limiting the intake of caffeinated foods and beverages.",2020,"Children frequently consumed less than the recommended daily intake of key nutrients such as fiber, vegetables, whole fruit, and vitamins.
","['106 children were followed for 24-36 months', 'Mothers were obese Latina women, enrolled prenatally, and their infants', 'Young Children', '174 infants randomized', 'Forty-two percent of children became overweight or obese', 'very young children']","['Caffeine', 'Calories, Caffeine', 'educational intervention', 'caffeine']","['higher consumption of calories, and added sugar and decreased intake of protein, fiber and dairy', 'Mean intake', 'overweight/obesity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",174.0,0.0211932,"Children frequently consumed less than the recommended daily intake of key nutrients such as fiber, vegetables, whole fruit, and vitamins.
","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'McCormick', 'Affiliation': 'University of Texas Medical Branch (DP McCormick), Galveston, Tex. Electronic address: david.mccormick@utmb.edu.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Reyna', 'Affiliation': 'College of Nursing and Health Innovation (L Reyna and E Reifsnider), Arizona State University, Phoenix, Ariz.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Reifsnider', 'Affiliation': 'College of Nursing and Health Innovation (L Reyna and E Reifsnider), Arizona State University, Phoenix, Ariz.'}]",Academic pediatrics,['10.1016/j.acap.2020.02.014']
150,31711219,Accounting for Blood Pressure Seasonality Alters Evaluation of Practice-Level Blood Pressure Control Intervention.,"BACKGROUND


Despite the large body of literature evaluating interventions to improve hypertension management, few studies have addressed seasonal variation in blood pressure (BP) control. This underreported phenomenon has implications for interpreting study findings and informing clinical care. We share a methodology that accounts for BP seasonality, presented through a case study-HealthyHearts NYC, an intervention aimed at increasing adherence to the Million Hearts BP control evidence-based guidelines in primary care practices.
METHODS


We used a randomized stepped-wedge design (n = 257 practices). Each intervention included 13 visits from practice facilitators trained in improving practice-level BP control over 12 months. Two models were used to assess the intervention effect-one that did not account for seasonality (model 1) and one that did (model 2). Model 2 was a re-specification of model 1 to include our proposed two fixed-effects terms to address BP seasonality.
RESULTS


Model 1 showed a significant negative association between the intervention and BP control (IRR = 0.98, 95% CI = 0.96-0.99, P ≤ 0.05). In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI = 0.97-1.01, P = 0.19).
CONCLUSIONS


These findings reveal that analyses that do not account for BP seasonality may not present an accurate picture of intervention effects. In our case study, accounting for BP seasonality turned a negative association into a null association. We recommend that when evaluating BP control, studies compare outcome measures across similar seasons and that the measurement period last long enough to account for seasonal effects.
CLINICAL TRIALS REGISTRATION


Trial registration number: NCT02646488.",2020,"In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI=0.97-1.01, p=.19).
",[],['practice facilitators trained in improving practice-level BP control over 12 months'],"['blood pressure (BP) control', 'BP control']",[],"[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0511216,"In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI=0.97-1.01, p=.19).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gepts', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cleland', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY.'}, {'ForeName': 'Winfred', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY.'}]",American journal of hypertension,['10.1093/ajh/hpz179']
151,1991748,The surgical treatment of ingrowing toenails.,"Two prospective studies of ingrowing toenail management were conducted. In the first, 163 patients (204 ingrowing nail edges) who had not had previous surgery were randomised and treated by total nail avulsion, nail edge excision, or nail edge excision with phenolisation of the germinal matrix; recurrence rates one year postoperatively were 73%, 73% and 9% respectively. In the second study, 63 ingrowing nail edges which had recurred after previous operations underwent nail edge excision and phenolisation. There was a 5% recurrence rate and 5% incidence of dystrophy of the nail one year after operation.",1991,There was a 5% recurrence rate and 5% incidence of dystrophy of the nail one year after operation.,['163 patients (204 ingrowing nail edges) who had not had previous surgery'],"['total nail avulsion, nail edge excision, or nail edge excision', 'nail edge excision and phenolisation']",['recurrence rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027343', 'cui_str': 'Nails, Ingrown'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1535576', 'cui_str': 'Total avulsion of nail plate (procedure)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}]",63.0,0.0133057,There was a 5% recurrence rate and 5% incidence of dystrophy of the nail one year after operation.,"[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Grieg', 'Affiliation': 'Hairmyres Hospital, East Kilbride, Glasgow.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ireland', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
152,32314781,Dual-Outcome Intention-to-Treat Analyses in the Women's Health Initiative Randomized Controlled Hormone Therapy Trials.,"Dual-outcome intention-to-treat hazard rate analyses have potential to complement single-outcome analyses for the evaluation of treatments or exposures in relation to multivariate time-to-response outcomes. Here we consider pairs formed from important clinical outcomes to obtain further insight into influences of menopausal hormone therapy on chronic disease. As part of the Women's Health Initiative, randomized, placebo-controlled hormone therapy trials of conjugated equine estrogens (CEE) among posthysterectomy participants and of these same estrogens plus medroxyprogesterone acetate (MPA) among participants with an intact uterus were carried out at 40 US clinical centers (1993-2016). These data provide the context for analyses covering the trial intervention periods and a nearly 20-year (median) cumulative duration of follow-up. The rates of multiple outcome pairs were significantly influenced by hormone therapy, especially over cumulative follow-up, providing potential clinical and mechanistic insights. For example, among women randomized to either regimen, hazard ratios for pairs defined by fracture during intervention followed by death from any cause were reduced and hazard ratios for pairs defined by gallbladder disease followed by death were increased, though these findings may primarily reflect single-outcome associations. In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE + MPA, and those for hypertension followed by death were increased with CEE + MPA but not with CEE.",2020,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.",['participants with uterus'],"['conjugated equine estrogens (CEE', 'estrogens plus medroxyprogesterone acetate (CEE+MPA', 'CEE+MPA', 'placebo']",['hazard ratios for diabetes followed by death'],"[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.125359,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': ''}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': ''}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Banack', 'Affiliation': ''}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': ''}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Beverly M', 'Initials': 'BM', 'LastName': 'Snively', 'Affiliation': ''}, {'ForeName': 'Margery', 'Initials': 'M', 'LastName': 'Gass', 'Affiliation': ''}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwaa033']
153,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
154,1991783,Conservative management or closed nailing for tibial shaft fractures. A randomised prospective trial.,We performed a prospective randomised trial on matched groups of patients with displaced tibial shaft fractures to compare conservative treatment with closed intramedullary nailing. The results showed conclusively that intramedullary nailing gave more rapid union with less malunion and shortening. Nailed patients had less time off work with a more predictable and rapid return to full function. We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft.,1991,We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft.,"['tibial shaft fractures', 'matched groups of patients with displaced tibial shaft fractures']","['Conservative management or closed nailing', 'intramedullary nailing', 'conservative treatment with closed intramedullary nailing', 'closed intramedullary nailing']",['time off work with a more predictable and rapid return to full function'],"[{'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}]","[{'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0189782,We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Hooper', 'Affiliation': 'Department of Orthopaedic Surgery & Musculoskeletal Medicine, Christchurch Hospital, New Zealand.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Keddell', 'Affiliation': ''}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Penny', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
155,32227638,Different Mismatch Concepts for Magnetic Resonance Imaging-Guided Thrombolysis in Unknown Onset Stroke.,"OBJECTIVE


To explore the prevalence of the perfusion-weighted imaging (PWI)-diffusion-weighted imaging (DWI) mismatch and response to intravenous thrombolysis in the WAKE-UP trial.
METHODS


We performed a prespecified post hoc analysis of ischemic stroke patients screened for DWI-fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI. We defined PWI-DWI mismatch as ischemic core volume < 70ml, mismatch volume > 10ml, and mismatch ratio > 1.2. Primary efficacy end point was a modified Rankin Scale score of 0-1 at 90 days, adjusted for age and symptom severity.
RESULTS


Of 1,362 magnetic resonance imaging-screened patients, 431 underwent PWI. Of these, 57 (13%) had a double mismatch, 151 (35%) only a DWI-FLAIR mismatch, and 54 (13%) only a PWI-DWI mismatch. DWI-FLAIR mismatch was more prevalent than PWI-DWI mismatch (48%, 95% confidence interval [CI] = 43-53% vs 26%, 95% CI = 22-30%; p < 0.0001). Screening for either one of the mismatch profiles resulted in a yield of 61% (95% CI = 56-65%). Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52). In an exploratory analysis in the small subgroup of 208 randomized patients with PWI, PWI-DWI mismatch status did not modify the treatment response (p for interaction = 0.73).
INTERPRETATION


Evaluating both the DWI-FLAIR and PWI-DWI mismatch patterns in patients with unknown time of stroke onset will result in the highest yield of thrombolysis treatment. The treatment benefit of alteplase in patients with a DWI-FLAIR mismatch seems to be driven not merely by the presence of a PWI-DWI mismatch, although this analysis was underpowered. ANN NEUROL 2020;87:931-938.",2020,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"['1,362 magnetic resonance imaging (MRI) screened patients, 431 underwent PWI', 'ischemic stroke patients screened for DWI - fluid-attenuated inversion recovery (FLAIR) mismatch in WAKE-UP who underwent PWI', 'patients with a DWI-FLAIR mismatch']",['perfusion-weighted imaging (PWI) - diffusion-weighted imaging'],"['modified Rankin Scale score of 0-1 at 90\u2009days, adjusted for age and symptom severity', 'Prevalence of PWI-DWI mismatch']","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",208.0,0.139603,Prevalence of PWI-DWI mismatch was similar in patients with (27%) or without (24%) DWI-FLAIR mismatch (p = 0.52).,"[{'ForeName': 'Lauranne', 'Initials': 'L', 'LastName': 'Scheldeman', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France; Université Lyon 1, F-69100, Villeurbanne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dupont', 'Affiliation': 'Department of Neurosciences, Laboratory for Cognitive Neurology, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'GrayNumber Analytics, Lomma, Sweden.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Department of Stroke Medicine, Claude Bernard University Lyon 1, CREATIS National Center for Scientific Research Mixed Unit of Research 5220-National Institute of Health and Medical Research U1206, National Institute of Applied Sciences of Lyon, Lyon Civil Hospices, Lyon, France.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Pedraza', 'Affiliation': 'Department of Radiology, Institute of Diagnostic Imaging, Dr Josep Trueta Hospital, Girona Institute of Biomedical Research, Marti and Julia de Salt Hospital Park - Building M2, Girona, Spain.'}, {'ForeName': 'Claus Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Department of Neurology, Head and Neurocenter, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25730']
156,1991755,Internal fixation of femoral neck fractures. Two methods compared.,"In a prospective randomised study, the Hansson pin technique for internal fixation of fractures of the femoral neck was compared with the Uppsala screw technique. The series consisted of 115 consecutive patients, 97 women and 18 men, with a mean age of 80 years. There were 56 patients treated with Hansson pins and 59 with Uppsala screws. After one year 22 patients had died, eight in the Hansson pin group and 14 in the Uppsala screw group (p = 0.28). Twenty-four complications had occurred, 18 in the Hansson pin group and six in the Uppsala screw group (p = 0.008). After exclusion of those with complications, the patients in the Hansson pin group had significantly more pain, less mobility, and a smaller proportion were living in their own homes.",1991,"Twenty-four complications had occurred, 18 in the Hansson pin group and six in the Uppsala screw group (p = 0.008).","['56 patients treated with Hansson pins and 59 with Uppsala screws', 'femoral neck fractures', '115 consecutive patients, 97 women and 18 men, with a mean age of 80 years']","['Hansson pin technique', 'Uppsala screw technique']","['pain, less mobility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",115.0,0.019739,"Twenty-four complications had occurred, 18 in the Hansson pin group and six in the Uppsala screw group (p = 0.008).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Olerud', 'Affiliation': 'Department of Orthopaedics, University Hospital, Uppsala, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rehnberg', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hellquist', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
157,32314132,"Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas.","BACKGROUND


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


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


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


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


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


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


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


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


clinicaltrials.gov , Identifier: NCT03881657.",2020,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"['Participants were recruited at a clinic between November 24, 2015, and June 30, 2016', 'chronically ill adults', 'persons with SPMI and co-morbid chronic disease in a US-Mexico border community', '416 participants', 'persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border', 'Persons with severe, persistent mental illness (SPMI', 'population with SPMI in a socioeconomically distressed region of the USA', 'Persons with Severe, Persistent Mental Illness in Southern Texas']","['reverse colocated integrated care', 'Receipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only', 'Reverse Colocated Integrated Care', 'reverse colocated integrated care intervention', 'usual care']","['adverse effects', 'blood pressure', 'health outcomes', 'HbA1c, BMI, total cholesterol, and depressive symptoms', 'blood pressure and HbA1c', 'systolic blood pressure', 'diastolic blood pressure']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",416.0,0.130521,Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure.,"[{'ForeName': 'Karen Sautter', 'Initials': 'KS', 'LastName': 'Errichetti', 'Affiliation': 'Department of Movement Arts, Health Promotion and Leisure Studies, Bridgewater State University, 325 Plymouth Street, Bridgewater, MA, 02325, USA. ksautter@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Gaitan', 'Affiliation': 'Health Resources in Action, Inc., Boston, MA, USA.'}, {'ForeName': 'M Marlen', 'Initials': 'MM', 'LastName': 'Ramirez', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Tropical Texas Behavioral Health, Inc., Edinburg, TX, USA.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05778-2']
158,32208487,Phase 2 trial of montelukast for prevention of pain in sickle cell disease.,"Cysteinyl leukotrienes (CysLTs) are lipid mediators of inflammation. In patients with sickle cell disease (SCD), levels of CysLTs are increased compared with controls and associated with a higher rate of hospitalization for pain. We tested the hypothesis that administration of the CysLT receptor antagonist montelukast would improve SCD-related comorbidities, including pain, in adolescents and adults with SCD. In a phase 2 randomized trial, we administered montelukast or placebo for 8 weeks. The primary outcome measure was a >30% reduction in soluble vascular cell adhesion molecule 1 (sVCAM), a marker of vascular injury. Secondary outcome measures were reduction in daily pain, improvement in pulmonary function, and improvement in microvascular blood flow, as measured by laser Doppler velocimetry. Forty-two participants with SCD were randomized to receive montelukast or placebo for 8 weeks. We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow. Although montelukast is an effective treatment for asthma, we did not find benefit for SCD-related outcomes. This clinical trial was registered at www.clinicaltrials.gov as #NCT01960413.",2020,"We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow.","['patients with sickle cell disease (SCD', 'Forty-two participants with SCD', 'sickle cell disease', 'adolescents and adults with SCD']","['montelukast', 'CysLT receptor antagonist montelukast', 'placebo', 'montelukast or placebo']","['levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow', 'reduction in daily pain, improvement in pulmonary function, and improvement in microvascular blood flow, as measured by laser Doppler velocimetry', 'soluble vascular cell adhesion molecule 1 (sVCAM), a marker of vascular injury', 'rate of hospitalization for pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0125642', 'cui_str': 'LTD4 receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0162462', 'cui_str': 'Velocimetry'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",42.0,0.530257,"We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM, reported pain, pulmonary function, or microvascular blood flow.","[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Field', 'Affiliation': 'Medical Sciences Institute, Versiti Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Adetola', 'Initials': 'A', 'LastName': 'Kassim', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandow', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Embury', 'Affiliation': 'Vanguard Therapeutics, Inc., Half Moon Bay, CA; and.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Vanguard Therapeutics, Inc., Half Moon Bay, CA; and.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Wilkerson', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Valencia', 'Initials': 'V', 'LastName': 'Bryant', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Simpson', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}]",Blood advances,['10.1182/bloodadvances.2019001165']
159,30349353,Development of a method to maximize the transcutaneous electrical nerve stimulation intensity in women with fibromyalgia.,"Introduction


Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention clinically used for pain relief. The importance of utilizing the adequate stimulation intensity is well documented; however, clinical methods to achieve the highest possible intensity are not established.
Objectives


Our primary aim was to determine if exposure to the full range of clinical levels of stimulation, from sensory threshold to noxious, would result in higher final stimulation intensities. A secondary aim explored the association of pain, disease severity, and psychological variables with the ability to achieve higher final stimulation intensity.
Methods


Women with fibromyalgia (N=143) were recruited for a dual-site randomized controlled trial - Fibromyalgia Activity Study with TENS (FAST). TENS electrodes and stimulation were applied to the lumbar area, and intensity was increased to sensory threshold (ST), then to ""strong but comfortable"" (SC1), then to ""noxious"" (N). This was followed by a reduction to the final stimulation intensity of ""strong but comfortable"" (SC2). We called this the Setting of Intensity of TENS (SIT) test.
Results


There was a significant increase from SC1 (37.5 mA IQR: 35.6-39.0) to SC2 (39.2 mA IQR: 37.1-45.3) ( p <0.0001) with a mean increase of 1.7 mA (95% CI: 1.5, 2.2). Linear regression analysis showed that those with the largest increase between SC1 and N had the largest increase in SC2-SC1. Further, those with older age and higher anxiety were able to achieve greater increases in intensity (SC2-SC1) using the SIT test.
Conclusion


The SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety. Thus, although all patients may benefit from this protocol, older women and women with elevated anxiety receive the greatest benefit.",2018,"The SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety.","['women with fibromyalgia', 'Methods\n\n\nWomen with fibromyalgia (N=143']","['TENS (FAST', 'Introduction\n\n\nTranscutaneous electrical nerve stimulation (TENS']","['intensity (SC2-SC1', 'SC1', 'SC2-SC1', 'older age and higher anxiety', 'age and anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",143.0,0.0495638,"The SC2-SC1 increase was significantly associated with age and anxiety, with greater mean increases associated with older age and higher anxiety.","[{'ForeName': 'Carol Gt', 'Initials': 'CG', 'LastName': 'Vance', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Chimenti', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine/Rheumatology & Immunology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Alemo Munters', 'Affiliation': 'Department of Medicine/Rheumatology & Immunology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Department of Medicine/Rheumatology & Immunology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, The University of Iowa Carver College of Medicine, Iowa City, IA, USA, carol-vance@uiowa.edu.'}]",Journal of pain research,['10.2147/JPR.S168297']
160,30157911,Physical activity is related to function and fatigue but not pain in women with fibromyalgia: baseline analyses from the Fibromyalgia Activity Study with TENS (FAST).,"BACKGROUND


Although exercise is an effective treatment for fibromyalgia, the relationships between lifestyle physical activity and multiple symptomology domains of fibromyalgia are not clear. Thus, the purpose of this study was to comprehensively examine the relationships between lifestyle physical activity with multiple outcome domains in women with fibromyalgia, including pain, fatigue, function, pain-related psychological constructs, and quality of life.
METHODS


Women (N = 171), aged 20 to 70 years, diagnosed with fibromyalgia, recruited from an ongoing two-site clinical trial were included in this prespecified subgroup analysis of baseline data. Physical activity was assessed using self-report and accelerometry. Symptomology was assessed using questionnaires of perceived physical function, quality of life, fatigue, pain intensity and interference, disease impact, pain catastrophizing, and fear of movement. In addition, quantitative sensory testing of pain sensitivity and performance-based physical function were assessed. Correlation coefficients, regression analyses and between-group differences in symptomology by activity level were assessed, controlling for age and body mass index (BMI).
RESULTS


Lifestyle physical activity was most closely associated with select measures of physical function and fatigue, regardless of age and BMI. Those who performed the lowest levels of lifestyle physical activity had poorer functional outcomes and greater fatigue than those with higher physical activity participation. No relationships between lifestyle physical activity and pain, pain sensitivity, or pain-related psychological constructs were observed.
CONCLUSIONS


Lifestyle physical activity is not equally related to all aspects of fibromyalgia symptomology. Lifestyle physical activity levels have the strongest correlations with function, physical quality of life, and movement fatigue in women with fibromyalgia. No relationships between lifestyle physical activity and pain, pain sensitivity, or psychological constructs were observed. These data suggest that physical activity levels are more likely to affect function and fatigue, but have negligible relationships with pain and pain-related psychological constructs, in women with fibromyalgia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01888640 . Registered on 28 June 2013.",2018,Those who performed the lowest levels of lifestyle physical activity had poorer functional outcomes and greater fatigue than those with higher physical activity participation.,"['women with fibromyalgia', 'Women (N\u2009=\u2009171), aged 20 to 70\xa0years, diagnosed with fibromyalgia, recruited from an ongoing two-site clinical trial', 'women with fibromyalgia, including']",['TENS (FAST'],"['function, physical quality of life, and movement fatigue', 'questionnaires of perceived physical function, quality of life, fatigue, pain intensity and interference, disease impact, pain catastrophizing, and fear of movement', 'quantitative sensory testing of pain sensitivity and performance-based physical function', 'symptomology by activity level', 'physical function and fatigue, regardless of age and BMI', 'Physical activity', 'lifestyle physical activity and pain, pain sensitivity, or psychological constructs', 'lifestyle physical activity and pain, pain sensitivity, or pain-related psychological constructs', 'pain, fatigue, function, pain-related psychological constructs, and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",,0.0893667,Those who performed the lowest levels of lifestyle physical activity had poorer functional outcomes and greater fatigue than those with higher physical activity participation.,"[{'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'Department of Physical Therapy, Steinhardt School of Culture, Education, and Human Development, New York University, New York, NY, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Frey-Law', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Department of Medicine/Rheumatology & Immunology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Department of Medicine/Rheumatology & Immunology, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, USA. kathleen-sluka@uiowa.edu.'}]",Arthritis research & therapy,['10.1186/s13075-018-1671-3']
161,31825554,Evaluation of the performance of two neutral oral contrast agents in computed tomography enterography: A randomized controlled trial.,"OBJECTIVE


To compare the performances, tolerability and acceptability of mannitol and polyethylene glycol (PEG) as oral contrast agents in patients undergoing computed tomography enterography (CTE).
METHODS


Patients aged 18-75 years indicated for CTE were randomized to receive either mannitol or PEG as contrast agents. The coronal reconstructed images of each abdominal quadrant were assessed for maximum distention, proportion of distended bowel loops, presence of inhomogeneous contents and visibility of the small bowel wall. Overall subjective imaging quality assessment and patients' tolerability and acceptability were recorded.
RESULTS


Seventy patients were enrolled and randomized into two groups. In the per-protocol analysis, no significant differences in imaging quality was found in bowel distention maximum diameter, wall visibility and intestinal homogeneity (all P > 0.05). The mean nausea score was lower in the mannitol group (0 [0-0] vs 1.0 [0-3.0], P < 0.001). Mannitol was superior to PEG in taste (9.0 [8.0-10.0] vs 7.0 [5.0-8.0], P < 0.001), patients' willingness to reuse the drug (9.0 [8.0-10.0] vs 8.0 [7.0-9.0], P = 0.036), satisfaction (9.0 [8.0-10.0] vs 8.0 [7.0-9.0], P = 0.022) and ease of completion (9.0 [8.0-9.3] vs 8.0 [6.5-9.0], P = 0.030).
CONCLUSIONS


Both mannitol and PEG provided good bowel distention and visualization of the bowel wall. However, mannitol was significantly superior to PEG in patients' tolerability and acceptability.",2020,"In the per-protocol analysis, no significant differences in imaging quality was found in bowel distention maximum diameter, wall visibility and intestinal homogeneity (all P > 0.05).","['Patients aged 18-75\u2009years indicated for CTE', 'Seventy patients', 'patients undergoing computed tomography enterography (CTE']","['mannitol', 'mannitol and polyethylene glycol (PEG', 'Mannitol', 'mannitol or PEG', 'mannitol and PEG']","['mean nausea score', ""Overall subjective imaging quality assessment and patients' tolerability and acceptability"", 'good bowel distention and visualization of the bowel wall', 'bowel distention maximum diameter, wall visibility and intestinal homogeneity', 'satisfaction', 'tolerability and acceptability', 'imaging quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4274910', 'cui_str': 'Computed tomography enterography'}]","[{'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",70.0,0.108691,"In the per-protocol analysis, no significant differences in imaging quality was found in bowel distention maximum diameter, wall visibility and intestinal homogeneity (all P > 0.05).","[{'ForeName': 'Meng Qi', 'Initials': 'MQ', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Qing Shi', 'Initials': 'QS', 'LastName': 'Zeng', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yong Quan', 'Initials': 'YQ', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Weihai Central Hospital, Weihai, Shandong Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yue Yue', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Ming Ming', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yi Ning', 'Initials': 'YN', 'LastName': 'Sun', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Li Xiang', 'Initials': 'LX', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiu Li', 'Initials': 'XL', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiao Yun', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yan Qing', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}]",Journal of digestive diseases,['10.1111/1751-2980.12835']
162,32310197,Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial.,"BACKGROUND


Exercise training has positive effects on motor and cognitive performance which deteriorates over time in patients with Multiple Sclerosis (MS). The effects of task-oriented circuit training (TOCT) on motor and cognitive performance in patients with MS are not yet clear.
OBJECTIVE


The aims of this study are to investigate the effects of TOCT on balance, walking, manual dexterity, cognitive performance, and to determine the extent to which patients are able to transfer changes in their performance to activities of daily living.
METHODS


Twenty patients with MS (EDSS: 2-5.5), were randomly assigned to two groups; the task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10). The TOCTG received TOCT twice a week for six weeks while the CG performed the relaxation exercises at home. All patients were assessed by using Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire.
RESULTS


Balance and walking performance were improved after TOCT (p < 0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p > 0.05). The CG showed no changes in any measurements (p > 0.05).
CONCLUSIONS


TOCT is quite effective to improve balance and walking in patients with MS. However, further studies are needed to determine the effect of TOCT on cognitive performance.",2020,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","['Twenty patients with MS (EDSS: 2-5.5', 'patients with MS', 'patients with Multiple Sclerosis (MS', 'patients with multiple sclerosis']","['Exercise training', 'TOCT', 'task-oriented circuit training group (TOCTG, n:10) and the control group (CG, n:10', 'task-oriented circuit training (TOCT', 'task-oriented circuit training']","['Multiple Sclerosis Walking Scale, Nine-Hole Peg Test, Brief Repeatable Battery of Neuropsychological Tests, Multiple Sclerosis Neuropsychological Questionnaire', 'motor and cognitive performance', 'Modified Sensory Organization Test, Berg Balance Scale, Activities-specific Balance Confidence, Timed Up and Go, Functional Gait Assessment, 12-item', 'manual dexterity and cognitive performance except for verbal memory', 'balance, walking, manual dexterity, cognitive performance', 'Balance and walking performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",20.0,0.0146737,"RESULTS


Balance and walking performance were improved after TOCT (p <  0.05), whereas manual dexterity and cognitive performance except for verbal memory did not change significantly (p >  0.05).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Gulsen', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Soke', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",NeuroRehabilitation,['10.3233/NRE-203029']
163,32305379,Sensorimotor performance is improved by targeted memory reactivation during a daytime nap in healthy older adults.,"Sensorimotor consolidation occurs during sleep. However, the benefit of sleep-based consolidation decreases with age due to decreased sleep quality and quantity. This study aimed to enhance sensorimotor performance through repetitive delivery of task-based auditory cues during sleep, known as targeted memory reactivation (TMR). Healthy older adults performed a non-dominant arm throwing task before and after a 1 h nap. While napping, half of participants received TMR throughout the hour. Participants who received TMR during sleep demonstrated a greater overall change in throwing accuracy from the start of the first to the end of the second throwing task session. However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task. Findings support the use of TMR during sleep to enhance task-specific sensorimotor performance in healthy older adults despite age-related decreases in sleep quality and quantity. Future research is needed to evaluate the effects of TMR on rehabilitation protocols.",2020,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","['Healthy older adults', 'healthy older adults']","['task-based auditory cues', 'TMR']",['sleep quality and quantity'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",,0.0188997,"However, there was no generalization of throwing accuracy to variants of the task or to a novel dart throwing task.","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Scharf', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland Medical Center, 827 Linden Ave, Baltimore, MD, 21201, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Westlake', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Maryland School of Medicine, 100 Penn Street, Baltimore, MD, 21201, United States. Electronic address: kwestlake@som.umaryland.edu.'}]",Neuroscience letters,['10.1016/j.neulet.2020.134973']
164,32309876,"The Feasibility, Safety, and Efficacy of the Preemptive Indwelling of Double-J Stents in Percutaneous Nephrolithotomy Surgery: A Randomized Controlled Trial.","PURPOSE


The goal of this study is to compare the feasibility, safety, and efficacy of the preemptive indwelling of double-J stents (PI-DJS) versus the conventional preemptive indwelling of ureteral catheters (PI-UC) in percutaneous nephrolithotomy (PCNL) via a randomized, controlled clinical study.
MATERIALS AND METHODS


A total of 75 patients with complex renal calculi underwent PCNL surgery and were randomized, using random number table, to receive either a PI-DJS (37 cases) or a PI-UC (38 cases). All operations were performed by the same experienced surgeon. Several outcomes were measured, including duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications.
RESULTS


Guided by B-ultrasound, percutaneous passages were successfully established in all patients who then underwent one-stage PCNL. The time required to establish a passage using a PI-DJS was 7.5min, whereas that of the group who received a PI-UC was 11.5min (P < 0.01). There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (all P > 0.05).
CONCLUSION


PI-DJS during PCNL allowed for a reliable and stable reflux from the bladder into the renal pelvis to produce an artificial hydronephrosis without the formation of microbubbles, unlike conventional ureteral catheters.",2020,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","['Percutaneous Nephrolithotomy Surgery', '75 patients with complex renal calculi underwent PCNL surgery']","['Preemptive Indwelling of Double-J Stents', 'conventional preemptive indwelling of ureteral catheters (PI-UC', 'PI-DJS', 'preemptive indwelling of double-J stents (PI-DJS', 'percutaneous nephrolithotomy (PCNL']","['feasibility, safety, and efficacy', 'duration of operation, time to establish passage, level of hemoglobin decline, rate of stone clearance and incidence of complications', 'Feasibility, Safety, and Efficacy', 'operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences']","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",75.0,0.0259171,"There was no significant difference between the two groups in terms of operation duration, postoperative Hb decline rate, stone clearance rate, and perioperative complication incidences (p> 0.05).
","[{'ForeName': 'Fuding', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. bfd0816@hotmail.com.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JiMin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Urology journal,['10.22037/uj.v0i0.4957']
165,32305653,Effectiveness of mechanical debridement with and without antimicrobial photodynamic therapy against oral yeasts in children with gingivitis undergoing fixed orthodontic therapy.,"OBJECTIVE


The aim was to assess the effectiveness of mechanical debridement (MD) and antimicrobial photodynamic therapy (aPDT) against oral yeasts in children with gingivitis undergoing fixed orthodontic therapy (FOT).
METHODS


Individuals undergoing orthodontic treatment were included. Patients were randomly divided into 2-groups. In the test-group, patients underwent MD with adjuvant aPDT; and in the control-group, patients underwent MD alone. Demographic information was recorded using a questionnaire. An ultrasonic scaler was used to perform MD and aPDT was done using methylene blue and visible light. In both groups, gingival index, unstimulated whole salivary flow rate and oral yeasts counts were measured at baseline and compared at 6-months' follow-up. Group comparisons were performed and P < 0.05 was selected as an indicator of statistical significance.
RESULTS


Eighteen (10 males and 8 females) and 18 individuals (9 males and 9 females) were included in the test- and control groups. The mean age of individuals in the test and control groups were 16.6 ± 0.5 and 16.8 ± 0.4 years, respectively. At 6-months' follow-up, the GI was comparable among patients in the test- and control-group. In the test-group, the CFU/ml of oral yeasts were significantly higher at baseline compared with 6-months' follow-up (P < 0.05). In the control-group, there was no statistically significant difference in the CFU/ml of oral yeasts at baseline and 6-months' follow-up.
CONCLUSION


aPDT is a useful adjuvant to MD in reducing whole salivary oral yeasts counts among adolescents undergoing orthodontic treatment. In the sort-term, MD with and without aPDT is useful in reducing GI in adolescents undergoing orthodontic treatment.",2020,"In the control-group, there was no statistically significant difference in the CFU/ml of oral yeasts at baseline and 6-months' follow-up.
","['children with gingivitis undergoing fixed orthodontic therapy', 'Individuals undergoing orthodontic treatment were included', 'Eighteen (10 males and 8 females) and 18 individuals (9 males and 9 females', 'children with gingivitis undergoing fixed orthodontic therapy (FOT', 'adolescents undergoing orthodontic treatment']","['ultrasonic scaler', 'mechanical debridement with and without antimicrobial photodynamic therapy', 'aPDT', 'MD with adjuvant aPDT', 'mechanical debridement (MD) and without antimicrobial photodynamic therapy (aPDT']","['CFU/ml of oral yeasts', 'Demographic information', 'gingival index, unstimulated whole salivary flow rate and oral yeasts counts']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0183103', 'cui_str': 'Dental ultrasonic scaler'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0439361', 'cui_str': 'cfu/mL'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.0321767,"In the control-group, there was no statistically significant difference in the CFU/ml of oral yeasts at baseline and 6-months' follow-up.
","[{'ForeName': 'Naif Khalid Al', 'Initials': 'NKA', 'LastName': 'Malik', 'Affiliation': 'Department of Preventive Dental Science, Division of Orthodontics, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: naif.k.almalik@student.riyadh.edu.sa.'}, {'ForeName': 'Omar Hamad', 'Initials': 'OH', 'LastName': 'Alkadhi', 'Affiliation': 'Department of Preventive Dental Science, Division of Orthodontics, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: omar.alkadhi@riyadh.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101768']
166,31763948,"Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized Trial.","PURPOSE


In a preliminary clinical trial we assessed the efficacy of ejaculatory hood sparing GreenLight™ Laser prostate photoselective vaporization to preserve antegrade ejaculation and urodynamic relief of obstruction compared to standard GreenLight prostate photoselective vaporization.
MATERIALS AND METHODS


Standard prostate photoselective vaporization was classically performed in 24 patients. Ejaculatory hood sparing vaporization was performed with preservation of the paracollicular and supracollicular tissue proximal to the verumontanum in 25 patients. Patients were assessed at baseline, and 1, 3, 6 and 12 months postoperatively using the Ej-MSHQ (Ejaculatory Domain of Male Sexual Health Questionnaire) and the IIEF-15 (International Index of Erectile Function-15). The I-PSS (International Prostate Symptom Score), uroflowmetry and post-void residual urine volume were reported at each followup visit. A standard urodynamic study was performed at 6 months.
RESULTS


Antegrade ejaculation was reported in 85% and 31.6% of patients after hood sparing and standard prostate vaporization, respectively (p=0.001). A significant reduction in the EJ-MSHQ score was reported after standard vaporization at 6 and 12 months (each p <0.001) with no significant difference after hood sparing vaporization (p=0.18 and 0.078, respectively). The median EJ-MSHQ score was 28.5 (range 1 to 33) and 27 (range 1 to 33) for hood sparing vaporization, and 9.5 (range 1 to 35) and 9 (range 0 to 33) for standard vaporization at 6 (p=0.005) and 12 months (p <0.001), respectively. Each group showed a decline in the mean total IIEF-15 score at 1 year but it was statistically significant only after standard vaporization (p=0.001). All urinary outcome measures revealed comparable significant improvement at all followups. Postoperative urodynamic assessment demonstrated a significant comparable decrease in the Bladder Outlet Obstruction Index from a median of 64 (range 21 to 207) to 23.5 (range 10 to 53) after hood sparing vaporization (p=0.005) and from 87 (range 38 to 186) to 19.5 (range 7 to 51) after standard vaporization (p=0.001). At 1 year the overall re-treatment rate was comparable in the 2 groups (p=0.26).
CONCLUSIONS


In well informed, sexually interested patients ejaculatory hood sparing GreenLight prostate photoselective vaporization is feasible and effective treatment of small to moderate sized benign prostatic hyperplasia with a superior sexual function related outcome. Short-term relief of obstruction is objectively comparable to that of standard prostate photoselective vaporization.",2020,"At one year, overall retreatment rate was comparable between the two groups (p=0.26).
","['25 patients', '24 patients']","['Ejaculatory Hood Sparing vs. Standard GreenLight TM  Laser Photoselective Vaporization of the Prostate', 'EH-sparing Greenlight Laser photoselective vaporization of the prostate (GL.PVP', 'EH-sparing GL.PVP']","['mean total IIEF-15 score', 'Antegrade ejaculation', 'bladder outlet obstruction index', 'overall retreatment rate', 'EJ-MSHQ score', 'median EJ-MSHQ score', 'Postoperative urodynamic assessment', 'IPSS, uroflow and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0005694', 'cui_str': 'Bladder Outlet Obstruction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0371927,"At one year, overall retreatment rate was comparable between the two groups (p=0.26).
","[{'ForeName': 'Ahmed Elhussein', 'Initials': 'AE', 'LastName': 'Abolazm', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'El-Hefnawy', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed B', 'Initials': 'AB', 'LastName': 'Shehab-El-Din', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",The Journal of urology,['10.1097/JU.0000000000000685']
167,31595976,Interventions to improve psychosocial well-being in female BRCA-mutation carriers following risk-reducing surgery.,"BACKGROUND


Women who carry a pathogenic mutation in either a BRCA1 DNA repair associated or BRCA2 DNA repair associated (BRCA1 or BRCA2) gene have a high lifetime risk of developing breast and tubo-ovarian cancer. To manage this risk women may choose to undergo risk-reducing surgery to remove breast tissue, ovaries, and fallopian tubes. Surgery should increase survival, but can impact women's lives adversely at the psychological and psychosexual levels. Interventions to facilitate psychological adjustment and improve quality of life post risk-reducing surgery are needed.
OBJECTIVES


To examine psychosocial interventions in female BRCA carriers who have undergone risk-reducing surgery and to evaluate the effectiveness of such interventions on psychological adjustment and quality of life.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and Embase via Ovid, CINAHL, PsycINFO, Web of Science up to April 2019 and Scopus up to January 2018. We also handsearched abstracts of scientific meetings and other relevant publications.
SELECTION CRITERIA


We included randomised controlled trials (RCT), non-randomised studies (NRS), prospective and retrospective cohort studies and interventional studies using baseline and postintervention analyses in female BRCA carriers who have undergone risk-reducing surgery.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed eligibility studies for inclusion in the review. We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We screened 4956 records from the searches, selecting 34 unique studies for full-text scrutiny, of which two met the inclusion criteria: one RCT and one NRS. The included studies assessed 113 female BRCA carriers who had risk-reducing surgery, but there was attrition, and outcome data were not available for all participants at final study assessments. We assessed the RCT as at a high risk of bias whilst the NRS did not have a control group. Our GRADE assessment of the studies was very low-certainty due to the paucity of data and methodological shortcomings of the studies. The primary outcome of quality of life was only measured in the RCT and that was specific to the menopause. Both studies reported on psychological distress and sexual function. Neither study measured body image, perhaps because this is most often associated with risk-reducing mastectomy rather than oophorectomy.The RCT (66 participants recruited with 48 followed to 12 months) assessed the short- and long-term effects of an eight-week mindfulness-based stress reduction (MBSR) training programme on quality of life, sexual functioning, and sexual distress in female BRCA carriers (n = 34) in a specialised family cancer clinic in the Netherlands compared to female BRCA carriers (n = 32) who received usual care. Measurements on the Menopause-Specific Quality of Life Questionnaire (MENQOL) showed some improvement at 3 and 12 months compared to the usual care group. At 3 months the mean MENQOL scores were 3.5 (95% confidence interval (CI) 3.0 to 3.9) and 3.8 (95% CI 3.3 to 4.2) for the MBSR and usual care groups respectively, whilst at 12 months the corresponding values were 3.6 (95% CI 3.1 to 4.0) and 3.9 (95% CI 3.5 to 4.4) (1 study; 48 participants followed up at 12 months). However, these results should be interpreted with caution due to the very low-certainty of the evidence, where a lower score is better. Other outcome measures on the Female Sexual Function Index and the Female Sexual Distress Scale showed no significant differences between the two groups. Our GRADE assessment of the evidence was very low-certainty due to the lack of blinding of participants and personnel, attrition bias and self-selection (as only one-third of eligible women chose to participate in the study) and serious imprecision due to the small sample size and wide 95% CI.The NRS comprised 37 female BRCA carriers selected from three Boston-area hospitals who had undergone a novel sexual health intervention following risk-reducing salpingo-oophorectomy (RRSO) without a history of tubo-ovarian cancer. The intervention consisted of targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies, followed by two sessions of tailored telephone counselling. This was a single-arm study without a control group. Our GRADE assessment of the evidence was very low-certainty, and as there was no comparison group in the included study, we could not estimate a relative effect. The study reported change in psychosexual adjustment from baseline to postintervention (median 2.3 months) using measures of Female Sexual Function Index (n = 34), which yielded change with a mean of 3.91, standard deviation (SD) 9.12, P = 0.018 (1 study, 34 participants; very low-certainty evidence). The Brief Symptom Inventory, Global Severity Index yielded a mean change of 3.92, SD 5.94, P < 0.001. The Sexual Self-Efficacy Scale yielded change with a mean of 12.14, SD 20.56, P < 0.001. The Sexual Knowledge Scale reported mean change of 1.08, SD 1.50, P < 0.001 (n = 36). Participant satisfaction was measured by questionnaire, and 100% participants reported that they enjoyed taking part in the psychoeducation group and felt ""certain"" or ""very certain"" that they had learned new skills to help them cope with the sexual side effects of RRSO.
AUTHORS' CONCLUSIONS


The effect of psychosocial interventions on quality of life and emotional well-being in female BRCA carriers who undergo risk-reducing surgery is uncertain given the very low methodological quality in the two studies included in the review. The absence of such interventions highlights the need for partnership between researchers and clinicians in this specific area to take forward the patient-reported outcomes and develop interventions to address the psychosocial issues related to risk-reducing surgery in female BRCA carriers, particularly in this new era of genomics, where testing may become more mainstream and many more women are identified as gene carriers.",2019,Other outcome measures on the Female Sexual Function Index and the Female Sexual Distress Scale showed no significant differences between the two groups.,"['113 female BRCA carriers who had risk-reducing surgery, but there was attrition, and outcome data were not available for all participants at final study assessments', 'female BRCA carriers who undergo risk-reducing surgery', 'female BRCA carriers who have undergone risk-reducing surgery', '37 female BRCA carriers selected from three Boston-area hospitals who had undergone a novel sexual health intervention following risk-reducing salpingo-oophorectomy (RRSO) without a history of tubo-ovarian cancer', '34 participants; very low-certainty evidence', 'female BRCA carriers (n = 34) in a specialised family cancer clinic in the Netherlands compared to female BRCA carriers (n = 32) who received', 'female BRCA-mutation carriers following risk-reducing surgery', 'We screened 4956 records from the searches, selecting 34 unique studies for full-text scrutiny, of which two met the inclusion criteria: one RCT and one NRS', 'Women who carry a pathogenic mutation in either a BRCA1 DNA repair associated or BRCA2 DNA repair associated (BRCA1 or BRCA2) gene']","['psychosocial interventions', 'eight-week mindfulness-based stress reduction (MBSR) training programme', 'usual care', 'targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies, followed by two sessions of tailored telephone counselling']","['quality of life and emotional well-being', 'Sexual Self-Efficacy Scale', 'survival', 'quality of life', 'Female Sexual Function Index and the Female Sexual Distress Scale', 'quality of life, sexual functioning, and sexual distress', 'Female Sexual Function Index', 'psychological adjustment and quality of life', 'mean MENQOL scores', 'Participant satisfaction', 'psychological distress and sexual function', 'Menopause-Specific Quality of Life Questionnaire (MENQOL', 'Brief Symptom Inventory, Global Severity Index']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456917', 'cui_str': 'Tubo-ovarian (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0012899', 'cui_str': 'DNA Repair'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0034380'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",34.0,0.079293,Other outcome measures on the Female Sexual Function Index and the Female Sexual Distress Scale showed no significant differences between the two groups.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jeffers', 'Affiliation': 'Medical Genetics, Regional Medical Genetics Centre, Belfast Health and Social Care Trust, Lisburn Road, Belfast, UK, BT9 7AB.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Reid', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Fitzsimons', 'Affiliation': ''}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dempster', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012894.pub2']
168,31955480,Can combined online and face-to-face continuing medical education improve the clinical knowledge and skills of family doctors in Vietnam? A cluster randomised controlled trial.,"OBJECTIVES


To assess the effectiveness of a combined online and face-to-face continuing medical education (CME) programme, for improvement in clinical knowledge and skills of family doctors, in comparison with a control group; and to explore the self-reported satisfaction, competencies and confidence of those in the intervention group.
METHODS


We used a cluster randomised controlled trial, with pre- and post-testing, and a feedback survey at the end of the 18-month CME programme. The measurements consisted of a multiple-choice test, an objective structured clinical examination test and an anonymously self-administered questionnaire.
RESULTS


There were 58 family doctors from four provinces in the intervention group and 32 doctors from three provinces in control group, both in the Mekong Delta region in Vietnam. The mean age of participants was 47.8 years, and the female/male ratio was 1/2.9. After training, the intervention group had significantly higher scores on overall knowledge (mean difference = 1.4, 95% CI 1.0-1.86, P < 0.001; Cohen's d 1.36, Pearson's r 0.53), in four of the five education modules: peptic disorders, diabetes, hypertension and bone-muscle-joint diseases (Pearson's r 0.56, 0.56, 0.34 and 0.4, respectively), and in problem-solving skills (Pearson's r 0.27). Self-reports showed a positive learning attitude, strong interest and improved confidence and competency among doctors in the intervention group.
CONCLUSIONS


A combined online and face-to-face CME programme proved applicable and effective for improving the clinical knowledge and problem-solving skills of family doctors in Vietnam.",2020,"Self-reports showed a positive learning attitude, strong interest, and improved confidence and competency among doctors in the intervention group.
","['The mean age of participants was 47.8 years, and the female/male ratio was 1/2.9', '58 family doctors from 4 provinces in the intervention group and 32 doctors from 3 provinces in control group, both in the Mekong Delta region in Vietnam']",['combined online and face-to-face continuing medical education (CME) program'],"['overall knowledge', 'peptic disorders, diabetes, hypertension, and bone-muscle-joint diseases']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443277', 'cui_str': 'Peptic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}]",,0.0643247,"Self-reports showed a positive learning attitude, strong interest, and improved confidence and competency among doctors in the intervention group.
","[{'ForeName': 'Thuy T N', 'Initials': 'TTN', 'LastName': 'Thai', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Kien T', 'Initials': 'KT', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Pham', 'Affiliation': 'Faculty of Public Health, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Phuong M', 'Initials': 'PM', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Anselme', 'Initials': 'A', 'LastName': 'Derese', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13372']
169,31487383,Rituximab is an effective treatment in patients with pemphigus vulgaris and demonstrates a steroid-sparing effect.,"BACKGROUND


Corticosteroids (CS) with or without adjuvant immunosuppressant agents are standard treatment for pemphigus vulgaris (PV). The efficacy of adjuvant therapies in minimizing steroid-related adverse events (AEs) is unproven.
OBJECTIVES


To utilize data collected in a French investigator-initiated, phase III, open-label, randomized controlled trial to demonstrate the efficacy and safety of rituximab and seek approval for its use in PV.
METHODS


This was an independently conducted post hoc analysis of the moderate-to-severe PV subset enrolled in the Ritux 3 study. Patients were randomized to rituximab plus 0·5 or 1·0 mg kg -1  per day prednisone tapered over 3 or 6 months, or 1·0 or 1·5 mg kg -1  per day prednisone alone tapered over 12 or 18 months, respectively (according to disease severity). The primary end point was complete remission at month 24 without CS (CRoff) for ≥ 2 months, and 24-month efficacy and safety results were also reported.
RESULTS


At month 24, 34 of 38 patients (90%) on rituximab plus prednisone achieved CRoff ≥ 2 months vs. 10 of 36 patients (28%) on prednisone alone. Median total cumulative prednisone dose was 5800 mg in the rituximab plus prednisone arm vs. 20 520 mg for prednisone alone. Eight of 36 patients (22%) who received prednisone alone withdrew from treatment owing to AEs; one rituximab-plus-prednisone patient withdrew due to pregnancy. Overall, 24 of 36 patients (67%) on prednisone alone experienced a grade 3/4 CS-related AE vs. 13 of 38 patients (34%) on rituximab plus prednisone.
CONCLUSIONS


In patients with moderate-to-severe PV, rituximab plus short-term prednisone was more effective than prednisone alone. Patients treated with rituximab had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs. What's already known about this topic? Pemphigus vulgaris (PV) is the most common type of pemphigus. Corticosteroids, a standard first-line treatment for PV, have significant side-effects. Although their effects are unproven, adjuvant corticosteroid-sparing agents are routinely used to minimize steroid exposure and corticosteroid-related side-effects. There is evidence that the anti-CD20 antibody rituximab is effective in the treatment of patients with severe recalcitrant pemphigus and in patients with newly diagnosed pemphigus. What does this study add? This study provides a more detailed analysis of patients with PV enrolled in an investigator-initiated trial. Rituximab plus prednisone had a steroid-sparing effect and more patients achieved complete remission off prednisone. Fewer patients experienced grade 3 or grade 4 steroid-related adverse events than those on prednisone alone. This collaboration between academia and industry, utilizing independent post hoc analyses, led to regulatory authority approvals of rituximab in moderate-to-severe PV.",2020,Rituximab-treated patients had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs.,"['moderate to severe PV subset enrolled in the Ritux-3 study (ClinicalTrials', 'pemphigus vulgaris (PV', 'Patients with Pemphigus Vulgaris']","['rituximab plus short-term prednisone', 'rituximab', 'rituximab-plus-prednisone', 'Corticosteroids (CS) with or without adjuvant immunosuppressant agents', 'Rituximab', 'rituximab plus 0.5 or 1.0 mg/kg/day prednisone', 'rituximab plus prednisone', 'prednisone']","['experience severe or life-threatening CS-related AEs', 'complete remission at Month 24 without CS (CRoff']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030809', 'cui_str': 'Pemphigus Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.042923,Rituximab-treated patients had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs.,"[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Chen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Odueyungbo', 'Affiliation': 'Roche Products Ltd, Mississauga, ON, L5N 5M8, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Csinady', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gearhart', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lehane', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, AL7 1TW, U.K.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cheu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maho-Vaillant', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prost-Squarcioni', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hebert', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Houivet', 'Affiliation': 'Department of Dermatology, Avicenne Hospital and INSERM UMR1125, Paris 13 University, 93000, Bobigny, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Calbo', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caillot', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Golinski', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Labeille', 'Affiliation': 'Department of Dermatology, University of Saint Etienne, 42023, Saint Etienne, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Picard-Dahan', 'Affiliation': 'Department of Dermatology, Bichat - Claude Bernard Hospital, 75018, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Department of Dermatology, University of Toulouse, 31013, Toulouse, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Richard', 'Affiliation': 'Department of Dermatology, Assistance Publique des Hôpitaux de Marseille, Aix Marseille University, UMR 911, INSERM CRO2, 13007, Marseille, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Bouaziz', 'Affiliation': 'Department of Dermatology of Saint Louis Hospital, Paris 7 Sorbonne Paris Cité University, 75010, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Duvert-Lehembre', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bernard', 'Affiliation': 'Department of Dermatology, University of Reims, 51100, Reims, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caux', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alexandre', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ingen-Housz-Oro', 'Affiliation': 'Department of Dermatology, APHP, Henri Mondor Hospital, 94010, Créteil, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vabres', 'Affiliation': 'Department of Dermatology, Dijon University Hospital, 21079, Dijon, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'Department of Dermatology, University of Lille and Claude-Huriez Hospital, 59037, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Quereux', 'Affiliation': 'Department of Dermatology, University of Nantes, 44035, Nantes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupuy', 'Affiliation': 'Department of Dermatology, University of Rennes, 35042, Rennes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Debarbieux', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon Sud, 69310, Pierre Bénite, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Avenel-Audran', 'Affiliation': 'Department of Dermatology, University of Angers, 49035, Angers, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Incan"", 'Affiliation': 'Department of Dermatology, University of Clermont-Ferrand, 63001, Clermont-Ferrand, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bedane', 'Affiliation': 'Department of Dermatology, University of Limoges, 87032, Limoges, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Le Mans General Hospital, 72037, Le Mans, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jullien', 'Affiliation': 'Department of Dermatology, Edouard Herriot Hospital, Lyon Claude Bernard University, 69003, Lyon, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dupin', 'Affiliation': 'Department of Dermatology, Cochin Hospital, University of Paris V, 75006, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Misery', 'Affiliation': 'Department of Dermatology and, Brest University Hospital, 29200, Brest, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, Tours University Hospital, 37044, Tours, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'Department of Dermatology, University of Bordeaux, 33076, Bordeaux, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dereure', 'Affiliation': 'Department of Dermatology, University of Montpellier, 34090, Montpellier, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sassolas', 'Affiliation': 'Department of Internal Medicine, Brest University Hospital, 29200, Brest, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benichou', 'Affiliation': 'Department of Dermatology, Avicenne Hospital and INSERM UMR1125, Paris 13 University, 93000, Bobigny, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Musette', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.18482']
170,32310156,The effects of dry needling on pain relief and functional balance in patients with sub-chronic low back pain.,"BACKGROUND


Pain relief is important both for the movement of patients suffering from low back pain and the quality of life. Dry needling is effective on myofascial trigger points but its effect on the area of pain and the functional balance is not fully known.
OBJECTIVE


To examine the immediate effect of dry needling on pain and functional balance of patients suffering from low back pain.
METHODS


Twenty five patients with sub-chronic low back pain were randomly divided into two groups: the intervention or control group. Needles were used for the participants of the intervention group, bilaterally at the spinus level, one and a half finger breath from the midline in levels L2-L5 of the lumbar spine. A third line of needles was inserted in the interspinosus spaces, except L5-S1 level. Bipedal stance, lateral loading and mediolateral body sway were assessed using a pair of force plates. Pain tolerance was assessed using an algometer.
RESULTS


The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention. During mediolateral body sway the force signal in the dominant frequency significantly increased in the intervention group from (M = 43.2, SE 4.6) to (M = 54,9, SE 3.6) (F(1,23) = 4.63, p< 0.05) after intervention, exhibiting more controlled rhythmic behavior.
CONCLUSIONS


Dry needling in painful areas and penetrating all the muscle groups seems to improve pain and functional balance, yet its effect on specific muscles needs to be studied further.",2020,"The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention.","['Twenty five patients with sub-chronic low back pain', 'patients suffering from low back pain', 'patients with sub-chronic low back pain']","['Dry needling', 'dry needling']","['Pain tolerance', 'pain and functional balance', 'Bipedal stance, lateral loading and mediolateral body sway', 'pain tolerance', 'pain relief and functional balance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",25.0,0.0283228,"The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention.","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Loizidis', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Saint Loukes Hospital, Panorama, Thessaloniki, Greece.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nikodelis', 'Affiliation': 'Biomechanics Laboratory, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'El', 'Initials': 'E', 'LastName': 'Bakas', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Rehabilitation Center Euromedica Arogi, Thessaloniki, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kollias', 'Affiliation': 'Biomechanics Laboratory, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181265']
171,31812609,Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial.,"OBJECTIVES


Shortened sleep has negative consequences on adolescents' well-being. The present study evaluated an interactive school-based sleep education program (SEP) aimed at increasing adolescent sleep duration.
DESIGN AND INTERVENTION


A cluster-randomized controlled trial with 12 clusters (classes) was used. The intervention group received a SEP and the active control group received a healthy living program (HLP). Both groups underwent a 4-week class-based education program. The SEP students learned about the importance of sleep, the barriers to getting enough sleep, and how to improve their time management to increase their sleep opportunity. The HLP students learned about various health-related topics not including sleep.
PARTICIPANTS


A total of 210 students (mean age = 14.04 ± 0.32 years) were randomly assigned to the SEP (n = 102) or the HLP (n = 108) group, with 6 classes per group.
MEASUREMENTS


Sleep (actigraphically measured), sleep knowledge, and time usage were assessed using linear mixed models at three time points: baseline, immediately after intervention, and 1-month follow-up.
RESULTS


Sleep knowledge improved at follow-up in the SEP relative to the HLP group (p = .017). Although students were receptive of the program and self-reported the intention to create more time for sleep, no changes in sleep were found following the SEP. Some benefit may have been masked by exam preparations at the follow-up evaluation.
CONCLUSIONS


Sleep education alone may not be sufficient to change sleep behavior. A combination of sleep education, starting school later, and parental involvement may be needed to encourage and enable changes in adolescent sleep duration.",2020,"RESULTS


Sleep knowledge improved at follow-up in the SEP relative to the HLP group (p = .017).",['A total of 210 students (mean age\xa0= 14.04 ± 0.32 years'],"['SEP', 'HLP', '4-week\xa0class-based education program', 'interactive school-based sleep education program (SEP', 'interactive school-based sleep education program', 'SEP\xa0and the active control group received a healthy living program (HLP']","['Sleep (actigraphically measured), sleep knowledge, and time usage', 'Sleep knowledge']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",210.0,0.0279523,"RESULTS


Sleep knowledge improved at follow-up in the SEP relative to the HLP group (p = .017).","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'van Rijn', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Shirley Y J', 'Initials': 'SYJ', 'LastName': 'Koh', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Alyssa S C', 'Initials': 'ASC', 'LastName': 'Ng', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Ksenia', 'Initials': 'K', 'LastName': 'Vinogradova', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Nicholas I Y N', 'Initials': 'NIYN', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Su Mei', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gooley', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore 169857; Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117594. Electronic address: michael.chee@nus.edu.sg.'}]",Sleep health,['10.1016/j.sleh.2019.10.006']
172,31944502,4-month moxifloxacin containing regimens in the treatment of patients with sputum-positive pulmonary tuberculosis in South India - a randomised clinical trial.,"BACKGROUND


Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3- and 4-month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
METHODS


New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients were randomised to 3- or 4-month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H 3  R 3  Z 3  E 3  /4R 3  H 3  ) [C]. The 4 test regimens were 3R 7  H 7  Z 7  E 7  M 7  [M3], 2R 7  H 7  Z 7  E 7  M 7  /2R 7  H 7  M 7  [M4], 2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  M 3  [M4-I] or 2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  E 3  M 3  [M4-IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The primary end point was TB recurrence post-treatment.
RESULTS


Of 1371 patients, randomised, modified intention-to-treat (ITT) analysis was done in 1329 and per-protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. 'Favourable' response at end of treatment was 96-100% in the moxifloxacin regimens and 93% in the control  regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI -3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
CONCLUSION


The 4-month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6-month thrice-weekly control regimen.",2020,The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen.,"['1371 patients randomized, modified intention-to-treat (ITT) analysis was done in 1329 and per protocol (PP) analysis in 1223 patients', 'pulmonary TB (PTB) patients in South India', 'patients with sputum positive pulmonary tuberculosis in South India ', 'New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients']","['moxifloxacin', 'moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z), ethambutol(E)] or to a control regimen (2H 3  R 3  Z 3  E 3  /4R', '2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  M 3  [M4-I] or 2R 7  H 7  Z 7  E 7  M 7  /2R', 'moxifloxacin regimen [M4']","['TB recurrence post-treatment', 'efficacy and safety', 'TB recurrence rates. ', ""Favourable' response"", 'TB recurrence', 'TB recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0044222', 'cui_str': '1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine'}, {'cui': 'C1173706', 'cui_str': ""7-methoxy-6-(2'-methoxy-3'-hydroxy-3'-methyl butyl)""}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1371.0,0.0858817,The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen.,"[{'ForeName': 'Banurekha', 'Initials': 'B', 'LastName': 'Velayutham', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Mohideen Shaheed', 'Initials': 'MS', 'LastName': 'Jawahar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Nair', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Pooranagangadevi', 'Initials': 'P', 'LastName': 'Navaneethapandian', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Chinnaiyan', 'Initials': 'C', 'LastName': 'Ponnuraja', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Kandasamy', 'Initials': 'K', 'LastName': 'Chandrasekaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Gomathi', 'Initials': 'G', 'LastName': 'Narayan Sivaramakrishnan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Marimuthu', 'Initials': 'M', 'LastName': 'Makesh Kumar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Paramasivam', 'Initials': 'P', 'LastName': 'Paul Kumaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Santhanakrishnan', 'Initials': 'S', 'LastName': 'Ramesh Kumar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Dhanaraj', 'Initials': 'D', 'LastName': 'Baskaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bella Devaleenal', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Devarajulu Reddy', 'Initials': 'DR', 'LastName': 'Sirasanambati', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Vellore, India.'}, {'ForeName': 'Mahalingam', 'Initials': 'M', 'LastName': 'Vasantha', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Paramasivam', 'Initials': 'P', 'LastName': 'Palaniyandi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Ramachandran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Kadayam Ranganathan', 'Initials': 'KR', 'LastName': 'Uma Devi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Elizabeth Hannah', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Gomathi', 'Initials': 'G', 'LastName': 'Sekar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Ammayappan', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Dharuman', 'Initials': 'D', 'LastName': 'Kalaiselvi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Angamuthu', 'Initials': 'A', 'LastName': 'Dhanalakshmi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Elangovan', 'Initials': 'E', 'LastName': 'Thiruvalluvan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Murugesan', 'Initials': 'M', 'LastName': 'Raja Sakthivel', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Ayyamperumal', 'Initials': 'A', 'LastName': 'Mahilmaran', 'Affiliation': 'Institute of Thoracic Medicine, Chennai, India.'}, {'ForeName': 'Rathinam', 'Initials': 'R', 'LastName': 'Sridhar', 'Affiliation': 'Government Hospital for Thoracic Medicine, Chennai, India.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Jayabal', 'Affiliation': 'Revised National TB Control Programme, Chennai, India.'}, {'ForeName': 'Prabhakaran', 'Initials': 'P', 'LastName': 'Rathinam', 'Affiliation': 'Government Rajaji Hospital, Madurai, India.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Angamuthu', 'Affiliation': 'Government Vellore Medical College Hospital, Vellore, India.'}, {'ForeName': 'Kumaresan', 'Initials': 'K', 'LastName': 'Soorappa Ponnusamy', 'Affiliation': 'Government Vellore Medical College Hospital, Vellore, India.'}, {'ForeName': 'Perumal', 'Initials': 'P', 'LastName': 'Venkatesan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Natrajan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Prasad Tripathy', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13371']
173,32306296,Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.,"INTRODUCTION


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


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


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


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


ClinicalTrials.gov identifiers: NCT00637273, NCT00676338, NCT02229383, NCT02229396, NCT00641056, NCT01652729, NCT00935532, NCT01003184.",2020,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","['Participants with baseline', 'participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR]\u2009≥\u200930 to\u2009<\u200960\xa0mL', 'participants with type 2 diabetes and', 'participants with type 2 diabetes with mild and moderate renal impairment', 'Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease']","['EQW', 'exenatide', 'pioglitazone', 'Exenatide', 'CKD3', 'EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin']","['Safety and Efficacy', 'mean blood pressure and glycated haemoglobin (HbA 1c ', 'safety and efficacy', 'nausea and vomiting', 'Gastrointestinal AE rates', 'efficacy and renal and gastrointestinal tolerability', 'adverse event (AE', 'serious AE of acute kidney injury', 'Mean reductions in HbA 1c , body weight and systolic blood pressure']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.191815,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. cristian.guja@b.astral.ro.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marr', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00815-z']
174,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma.
METHODS


It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months.
RESULTS


In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months.
CONCLUSION


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
175,32089436,Relationship Between Vascular Risk Factors and Location of Intracranial Atherosclerosis in the SAMMPRIS Trial.,"BACKGROUND


Previous studies have reported that different locations of intracranial atherosclerosis (ICAS) are associated with different demographic features and vascular risk factors. We aimed to examine this observation in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial population.
METHODS


SAMMPRIS was a randomized controlled trial that enrolled 451 patients with recent transient ischemic attack or stroke-related due to severe (70%-99%) stenosis of a major intracranial artery. We compared the baseline demographic features and vascular risk factors between the symptomatic artery locations. Wilcoxon test was used to compare continuous variables, and chi-square test was used for categorical variables.
RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation. Features that were significantly different between patients with anterior versus posterior ICAS were: median age (58.3 years versus 64.0 years, P < .001), males/females (52.9%/47.1% versus 74.4%/25.6% P < .001), white/black (66.8%/26.6% versus 79.4%/16.9%, P = .02), and history of hyperlipidemia (85.5% versus 92.5%, P = .03).
CONCLUSIONS


The observed differences in the distribution of demographic characteristics and vascular risk factors depending on the location of symptomatic ICAS suggest the possibility of different underlying pathological processes involved in the formation of atherosclerotic plaques in different locations.",2020,"RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation.","['enrolled 451 patients with recent transient ischemic attack or stroke-related due to severe (70%-99%) stenosis of a major intracranial artery', 'Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation']",[],['history of hyperlipidemia'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0447028', 'cui_str': 'Structure of intracranial artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}]",451.0,0.203822,"RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation.","[{'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Kasab', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Yamada', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': ""Renee' H"", 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104713']
176,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
177,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
178,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
179,31805247,Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial.,"Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test-Disability Questionnaire (Swinburn, Porter, & Howard, 2004) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire (Glueckauf et al., 2003) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.",2019,There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment.,"['58 Persons With Aphasia', '58 persons with aphasia characterized by anomia and phonological dysfunction']",['Phonomotor Versus Semantic Feature Analysis Treatment'],"['confrontation naming and response latency', 'response latency', 'Functional Outcome Questionnaire', 'Comprehensive Aphasia Test-Disability Questionnaire (Swinburn, Porter, & Howard, 2004']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0003113', 'cui_str': 'Anomic Dysphasia'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4505400', 'cui_str': 'Comprehensive Aphasia Test'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0402671', 'cui_str': 'Porter (occupation)'}]",58.0,0.0415903,There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment.,"[{'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kendall', 'Affiliation': 'Rehabilitation Research and Development Service, VA Puget Sound DVA Medical Center, Seattle, WA.'}, {'ForeName': 'Megan Oelke', 'Initials': 'MO', 'LastName': 'Moldestad', 'Affiliation': 'Rehabilitation Research and Development Service, VA Puget Sound DVA Medical Center, Seattle, WA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Allen', 'Affiliation': 'Rehabilitation Research and Development Service, VA Puget Sound DVA Medical Center, Seattle, WA.'}, {'ForeName': 'Janaki', 'Initials': 'J', 'LastName': 'Torrence', 'Affiliation': 'Department of Speech & Hearing Sciences, University of Washington, Seattle.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Nadeau', 'Affiliation': 'Research Service, Malcom Randall VA Medical Center, Gainesville, FL.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0257']
180,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
181,31765277,Technology-Enhanced Reading Therapy for People With Aphasia: Findings From a Quasirandomized Waitlist Controlled Study.,"Purpose This study investigated the effects of technology-enhanced reading therapy for people with reading impairments, using mainstream assistive reading technologies alongside reading strategies. Method The study used a quasirandomized waitlist controlled design. Twenty-one people with reading impairments following stroke were randomly assigned to receive 14 hr of therapy immediately or after a 6-week delay. During therapy, participants were trained to use assistive reading technology that offered a range of features to support reading comprehension. They developed skills in using the technology independently and in applying the technology to their personal reading goals. The primary outcome measure assessed reading comprehension, using Gray Oral Reading Test-Fourth Edition (GORT-4). Secondary measures were as follows: Reading Comprehension Battery for Aphasia-Second Edition, Reading Confidence and Emotions Questionnaire, Communication Activities of Daily Living-Second Edition, Visual Analog Mood Scales, and Assessment of Living With Aphasia. Matched texts were used with the GORT-4 to compare technology-assisted and unassisted reading comprehension. Mixed analyses of variance explored change between T1 and T2, when the immediate group had received therapy but the delayed group had not, thus serving as untreated controls. Pretherapy, posttherapy, and follow-up scores on the measures were also examined for all participants. Results GORT-4 results indicated that the immediately treated group improved significantly in technology-assisted reading following therapy, but not in unassisted reading. However, the data were not normally distributed, and secondary nonparametric analysis was not significant. The control group was unstable over the baseline, improving significantly in unassisted reading. The whole-group analysis showed significant gains in assisted (but not unassisted) reading after therapy that were maintained at follow-up. The Reading Confidence and Emotions Questionnaire results improved significantly following therapy, with good maintenance of change. Results on all other secondary measures were not significant. Conclusions Technology-assisted reading comprehension improved following the intervention, with treatment compensating for, rather than remediating, the reading impairment. Participants' confidence and emotions associated with reading also improved. Gains were achieved after 14 therapy sessions, using assistive technologies that are widely available and relatively affordable, meaning that this approach could be implemented in clinical practice.",2019,The whole-group analysis showed significant gains in assisted (but not unassisted) reading after therapy that were maintained at follow-up.,"['People With Aphasia', 'Twenty-one people with reading impairments following stroke', 'people with reading impairments']","['Technology-Enhanced Reading Therapy', 'technology-enhanced reading therapy']","['technology-assisted reading', 'Reading Comprehension Battery for Aphasia-Second Edition, Reading Confidence and Emotions Questionnaire, Communication Activities of Daily Living-Second Edition, Visual Analog Mood Scales, and Assessment of Living With Aphasia', 'reading comprehension, using Gray Oral Reading Test-Fourth Edition (GORT-4', 'Reading Confidence and Emotions Questionnaire results']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C4304063', 'cui_str': 'Reading Comprehension Battery for Aphasia Second Edition (assessment scale)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4273602', 'cui_str': 'Communication Activities of Daily Living Second Edition (assessment scale)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",21.0,0.0287115,The whole-group analysis showed significant gains in assisted (but not unassisted) reading after therapy that were maintained at follow-up.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Caute', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Woolf', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Human Computer Interaction Design, City University of London, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stokes', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Monnelly', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Cruice', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bacon', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0484']
182,32303761,Pregnant Smokers Receiving Opioid Agonist Therapy Have an Elevated Nicotine Metabolite Ratio: A Replication Study.,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes per day (CPD) and had a higher nicotine metabolite ratio (NMR), 3-hydroxycotinine/cotinine, a biomarker of nicotine metabolism and clearance, than those not receiving opioids. We examined CPD and NMR in a group of pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT).
AIMS AND METHODS


Pregnant smokers recruited to participate in a placebo-controlled trial of bupropion for smoking cessation provided a blood sample for measurement of NMR.
RESULTS


Half (52.4%) of the 124 women with NMR data were African American. OAT-treated women (n = 34, 27.4%; 27 receiving methadone and 7 buprenorphine) were more likely to be white (79% vs. 30%, p < .001) and to have a lower mean PHQ-9 total score (2.91 [SD = 2.83] vs. 4.83 [SD = 3.82], p = .007). OAT-treated women reported smoking more CPD (9.50 [SD = 5.26] vs. 7.20 [SD = 3.65], p = .005) and had higher NMR (0.78 [SD = 0.36] vs. 0.56 [SD = 0.25], p = .001) than the non-OAT-treated group. In a linear regression analysis adjusting for race, depression severity, and CPD, NMR was greater in the OAT group (p = .025), among whom the daily methadone-equivalent dosage correlated with NMR (Spearman's ρ = 0.49, p = .003).
CONCLUSIONS


Consistent with the findings of Oncken et al. (2019), we found that OAT smokers smoked more and had higher NMR than non-OAT smokers. As higher NMR is associated with a reduced likelihood of smoking cessation, the effects on NMR of both pregnancy and OAT could contribute to a lower smoking cessation rate in pregnant smokers receiving chronic opioid therapy.
IMPLICATIONS


We replicated the finding that the NMR is significantly greater among pregnant smokers receiving OAT than those not receiving this treatment for opioid use disorder. Furthermore, we found that the dosage of the OAT was significantly associated with the NMR level. These findings may contribute to a poorer response to smoking cessation treatment in pregnant women treated with OAT, particularly those receiving high-dose therapy, and raise the question of whether novel approaches are needed to treat smoking in this subgroup of pregnant smokers.",2020,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine), a biomarker of nicotine metabolism and clearance, than those not receiving opioids (Oncken et al 2019).","['124 women with NMR data were African American', 'pregnant smokers receiving chronic opioid therapy', 'Pregnant Smokers Receiving', 'OAT-treated women [N=34 (27.4', 'pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT', 'Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher', 'Pregnant smokers recruited to participate in a']","['bupropion', 'Opioid Agonist Therapy', 'nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine', 'buprenorphine', 'placebo', 'CPD and NMR', 'methadone']","['mean PHQ-9 total score', 'depression severity, and CPD, NMR']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C5192328', 'cui_str': '27.4'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0063125', 'cui_str': 'Trans-3-hydroxycotinine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",124.0,0.0365849,"INTRODUCTION


Pregnant women exposed chronically to opioids smoked more cigarettes/day (CPD) and had a higher nicotine metabolite ratio (NMR: 3-hydroxycotinine (3HC)/cotinine), a biomarker of nicotine metabolism and clearance, than those not receiving opioids (Oncken et al 2019).","[{'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Zindel', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Center for Studies of Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Hand', 'Affiliation': 'Departments of Obstetrics & Gynecology and Psychiatry & Human Behavior, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Oncken', 'Affiliation': 'Departments of Medicine and Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa066']
183,32301122,Rosuvastatin use increases plasma fibrinolytic potential: a randomised clinical trial.,"We conducted a study to assess the effect of rosuvastatin use on fibrinolysis in patients with previous venous thromboembolism (VTE). This was a post hoc analysis within the STAtins Reduce Thrombophilia (START) study (NCT01613794). Plasma fibrinolytic potential, fibrinogen, plasmin inhibitor, plasminogen activator inhibitor-1 (PAI-1) and thrombin-activatable fibrinolysis inhibitor (TAFI) were measured before and after four weeks of rosuvastatin or no treatment in participants with prior confirmed VTE, after ending anticoagulant therapy. In the non-rosuvastatin group (n = 121), plasma fibrinolytic potential and individual fibrinolysis parameters did not change at the end of the study versus the baseline, whereas in the rosuvastatin group (n = 126), plasma fibrinolytic potential increased: the mean clot lysis time decreased by 8·75 min (95% CI -13·8 to -3·72), and plasmin inhibitor levels and TAFI activity were lower at the end of the study (-0·05 U/ml; 95% CI -0·07 to -0·02 and -4·77%; 95% CI -6·81 to -2·73, respectively). PAI-1 levels did not change and fibrinogen levels were 0·17 g/l (95% CI 0·04-0·29) higher. In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use. Our findings support the need for further studies on the possible role for statins in the secondary prevention of VTE.",2020,"In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use.","['patients with previous venous thromboembolism (VTE', 'participants with prior confirmed VTE, after ending anticoagulant therapy']","['rosuvastatin', 'Rosuvastatin']","['Plasma fibrinolytic potential, fibrinogen, plasmin inhibitor, plasminogen activator inhibitor-1 (PAI-1) and thrombin-activatable fibrinolysis inhibitor (TAFI', 'plasmin inhibitor levels and TAFI activity', 'plasma fibrinolytic potential increased: the mean clot lysis time', 'plasma fibrinolytic potential', 'PAI-1 levels', 'fibrinogen levels', 'plasma fibrinolytic potential and individual fibrinolysis parameters', 'fibrinolytic potential']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032139', 'cui_str': 'Plasmin inhibitor'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0255161', 'cui_str': 'Carboxypeptidase U'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200464', 'cui_str': 'Fibrinolysin assay, screening'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0523053,"In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schol-Gelok', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Moniek P M', 'Initials': 'MPM', 'LastName': 'de Maat', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Biedermann', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank W G', 'Initials': 'FWG', 'LastName': 'Leebeek', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'Lijfering', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Felix J M', 'Initials': 'FJM', 'LastName': 'van der Meer', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Dingeman C', 'Initials': 'DC', 'LastName': 'Rijken', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jorie', 'Initials': 'J', 'LastName': 'Versmissen', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marieke J H A', 'Initials': 'MJHA', 'LastName': 'Kruip', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}]",British journal of haematology,['10.1111/bjh.16648']
184,32270017,"Development, implementation, and evaluation of a curriculum for medical students on conflicts of interest and communicating risk.","Background:  Insufficient risk competence of physicians, conflicts of interests from interactions with pharmaceutical companies, and the often distorted presentation of benefits and risks of therapies compromise the advising of patients by physicians in the framework of shared decision-making. An important cause of this is that teaching on this subject is mostly lacking, or fragmented when it does take place [1], [2], [3], [4]. Even though the  German National Competence-Based Catalog of Learning Goals in Medicine  defines learning goals on the topics of conflicts of interest and communication of risk, there are no classes that integrate both topics. Our goal was to develop a model curriculum to teach conflicts of interest and communication of risk that would integrate statistical know-how, communicational competency on the presentation of benefits and risks, and the meaning and management of conflicts of interest.  Project Description:  The development of the curriculum took place according to the six-step cycle of Kern et al [5]. An integrated curriculum was conceptualized, piloted, and adapted with the support of experts for the topics of shared decision-making, conflicts of interest, and communication of risk. The final version of the curriculum was implemented at the medical schools of Mainz and Heidelberg and evaluated by the students.  Results:  The final curriculum consists of 19 lesson units. The contents are the fundamentals of statistics, theory of risk communication, practical exercises on communication of risk, and the fundamentals of the mechanisms of effect of conflicts of interest, recognition of distortions in data, and introductions to professional management of conflicts of interest. The course was implemented three times at two different medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2).  Discussion:  The curriculum we developed fills a gap in the current medical education. The innovative concept, which sensibly connects the transmission of theory and practice, was positively received by the students. The next steps are an evaluation of the curriculum by means of a two-center randomized study and the implementation at German and international medical schools. The process should be accompanied by continuous evaluation and further improvement.",2020,"The course was implemented three times at two different medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2).  ","['medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2', 'medical students on conflicts of interest and communicating risk']",[],[],"[{'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0079152', 'cui_str': 'Conflict of Interest'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],[],32.0,0.0140516,"The course was implemented three times at two different medical schools with a total of 32 students, and it was positively rated by most of the 27 participating students who evaluated it on the 1-6 German school grading scale (mean: 1.4; SD: 0.49; range: 1-2).  ","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Deis', 'Affiliation': 'Institute of Medical and Pharmaceutical Examination Questions, Mainz, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'University Hospital of Mainz, Department of Psychiatry, Mainz, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dreimüller', 'Affiliation': 'University Hospital of Mainz, Department of Psychiatry, Mainz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gaitzsch', 'Affiliation': 'University Hospital of Heidelberg, Chest Clinic, Heidelberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Weißkircher', 'Affiliation': 'University Hospital of Mainz, Department of Psychiatry, Mainz, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jünger', 'Affiliation': 'Institute of Medical and Pharmaceutical Examination Questions, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Lieb', 'Affiliation': 'University Hospital of Mainz, Department of Psychiatry, Mainz, Germany.'}]",GMS journal for medical education,['10.3205/zma001296']
185,32302790,"Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial.","INTRODUCTION


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


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


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


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


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


CHRONOS will assess the oncological outcomes after FT compared to radical therapy and whether neoadjuvant treatments improve cancer control following one FT session.","[{'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. Electronic address: Deepika.reddy06@imperial.ac.uk.'}, {'ForeName': 'Taimur T', 'Initials': 'TT', 'LastName': 'Shah', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Dudderidge', 'Affiliation': 'Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'McCracken', 'Affiliation': 'Department of Urology, Sunderland Royal Hospital, Sunderland, UK; Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Manit', 'Initials': 'M', 'LastName': 'Arya', 'Affiliation': 'Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dobbs', 'Affiliation': 'Patient and Public Representative, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Department of Surgery and Interventional Sciences, University College London, University College Hospital, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sydes', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105999']
186,30346318,Comparison of Anorectal Manometry Testing in Left Lateral and Lithotomy Positions.,"OBJECTIVES


Anorectal manometry (ARM) is typically performed in left lateral position, but many practitioners are more familiar with the lithotomy position. We aimed to evaluate agreement between ARM performed in left lateral and lithotomy positions and patient preference for testing position.
METHODS


We performed a prospective comparison study of left lateral versus lithotomy position for women undergoing ARM for the evaluation of fecal incontinence. Women were randomly assigned to undergo testing in either left lateral position first followed by lithotomy position, or vice versa. Women then completed a survey assessing preference of position. We performed Bland-Altman analysis to measure the level of agreement between anorectal measurements obtained in the 2 positions.
RESULTS


Twenty-one women were enrolled (mean age, 65 ± 2.2 years). We noted an acceptable level of agreement between anal pressure values obtained in left lateral versus lithotomy positions: anal resting pressure (mean difference, 0.9 mm Hg; 95% limits of agreement, 30.2 and -28.5) and anal squeeze pressure (mean difference, 1.8 mm Hg; 95% limits of agreement, 54.3 and -50.7). The level of agreement for sensory values was outside the predetermined clinical acceptability range. Most women (17/21 [81%]) reported a ""good"" or ""very good"" experience in both positions.
CONCLUSIONS


Anorectal manometry testing in the 2 positions can be used interchangeably for anal resting and squeeze pressures, but not for anorectal sensation. This modification can be introduced into clinical practice to accommodate the preference of women and practitioners who favor lithotomy position.",2020,The level of agreement for sensory values was outside the predetermined clinical acceptability range.,"['Twenty-one women were enrolled (mean age, 65 ± 2.2 years', 'women undergoing ARM for the evaluation of fecal incontinence', 'women and practitioners who favor lithotomy position']","['Anorectal Manometry Testing', 'left lateral position first followed by lithotomy position, or vice versa', 'Anorectal manometry (ARM', 'left lateral versus lithotomy position']",['anal squeeze pressure'],"[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position (finding)'}]","[{'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C0559227', 'cui_str': 'Left lateral decubitus position (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0450414', 'cui_str': 'Lateral to the left (qualifier value)'}]","[{'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",21.0,0.0703176,The level of agreement for sensory values was outside the predetermined clinical acceptability range.,"[{'ForeName': 'Priyanka K', 'Initials': 'PK', 'LastName': 'Kadam-Halani', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Avita K', 'Initials': 'AK', 'LastName': 'Pahwa', 'Affiliation': 'Urogynecology, Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Nathanael C', 'Initials': 'NC', 'LastName': 'Koelper', 'Affiliation': ""Center for Research on Reproduction and Women's Health, Department of Obstetrics and Gynecology.""}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': ""Center for Research on Reproduction and Women's Health, Department of Obstetrics and Gynecology.""}, {'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000620']
187,31004126,Pulsed Near Infrared Transcranial and Intranasal Photobiomodulation Significantly Modulates Neural Oscillations: a pilot exploratory study.,"Transcranial photobiomodulation (tPBM) is the application of low levels of red or near-infrared (NIR) light to stimulate neural tissues. Here, we administer tPBM in the form of NIR light (810 nm wavelength) pulsed at 40 Hz to the default mode network (DMN), and examine its effects on human neural oscillations, in a randomized, sham-controlled, double-blinded trial. Using electroencephalography (EEG), we found that a single session of tPBM significantly increases the power of the higher oscillatory frequencies of alpha, beta and gamma and reduces the power of the slower frequencies of delta and theta in subjects in resting state. Furthermore, the analysis of network properties using inter-regional synchrony via weighted phase lag index (wPLI) and graph theory measures, indicate the effect of tPBM on the integration and segregation of brain networks. These changes were significantly different when compared to sham stimulation. Our preliminary findings demonstrate for the first time that tPBM can be used to non-invasively modulate neural oscillations, and encourage further confirmatory clinical investigations.",2019,These changes were significantly different when compared to sham stimulation.,[],"['Transcranial photobiomodulation (tPBM', 'electroencephalography (EEG', 'Pulsed Near Infrared Transcranial and Intranasal Photobiomodulation']",['Neural Oscillations'],[],"[{'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]",[],,0.0919509,These changes were significantly different when compared to sham stimulation.,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada. Reza.Zomorrodi@camh.ca.'}, {'ForeName': 'Genane', 'Initials': 'G', 'LastName': 'Loheswaran', 'Affiliation': 'Vielight Inc., Toronto, Ontario, Canada.'}, {'ForeName': 'Abhiram', 'Initials': 'A', 'LastName': 'Pushparaj', 'Affiliation': 'Ironstone Product Development Inc. & Qunuba Sciences Inc., Toronto, Ontario, Canada.'}, {'ForeName': 'Lew', 'Initials': 'L', 'LastName': 'Lim', 'Affiliation': 'Vielight Inc., Toronto, Ontario, Canada.'}]",Scientific reports,['10.1038/s41598-019-42693-x']
188,32301501,Response to Inhibition of Receptor-Interacting Protein Kinase 1 (RIPK1) in Active Plaque Psoriasis: A Randomized Placebo-Controlled Study.,"Receptor-interacting protein kinase 1 (RIPK1), a regulator of inflammation and cell death, is a potential therapeutic target in immune-mediated inflammatory diseases (IMIDs). The objective of this phase IIa multicenter, randomized, double-blind, placebo-controlled study was to evaluate safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy of GSK2982772, a RIPK1 inhibitor, in plaque-type psoriasis. Psoriasis patients (N = 65) were randomized to 60 mg twice daily (b.i.d.) or three times daily (t.i.d.), or placebo for 84 days. Most adverse events (AEs) were mild with no severe drug-related AEs reported. Plaque Lesion Severity Sum improved with b.i.d. treatment compared with placebo; interpretation of t.i.d. treatment results was complicated by a high placebo response. Reductions in epidermal thickness and infiltration by CD3+ T cells in the epidermis and dermis were observed compared with placebo. Results support the rationale for additional studies on RIPK1 inhibition in IMIDs.",2020,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"['plaque-type psoriasis', 'Psoriasis patients (N=65', 'active plaque psoriasis']","['receptor-interacting protein kinase 1 (RIPK1', 'placebo']","['safety, tolerability pharmacokinetics, pharmacodynamics', 'epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis', 'Plaque Lesion Severity Sum', 'adverse events (AEs']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0241148', 'cui_str': 'Cutaneous plaque'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.614395,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'InnovaDerm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Scott', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Tompson', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bertin', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Peter Tak', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1852']
189,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000']
190,32070122,Group-based music intervention in Parkinson's disease - findings from a mixed-methods study.,"OBJECTIVE


To evaluate a group-based music intervention in patients with Parkinson's disease.
DESIGN


Parallel group randomized controlled trial with qualitative triangulation.
SETTING


Neurorehabilitation in primary care.
SUBJECTS


Forty-six patients with Parkinson's disease were randomized into intervention group ( n  = 26), which received training with the music-based intervention, and control group ( n  = 20) without training.
INTERVENTIONS


The intervention was delivered twice weekly for 12 weeks.
MAIN MEASURES


Primary outcome was Timed-Up-and-Go subtracting serial 7's (dual-task ability). Secondary outcomes were cognition, balance, concerns about falling, freezing of gait, and quality of life. All outcomes were evaluated at baseline, post-intervention, and three months post-intervention. Focus groups and individual interviews were conducted with the intervention group and with the delivering physiotherapists.
RESULTS


No between-group differences were observed for dual-task ability. Between-group differences were observed for Falls Efficacy Scale (mean difference (MD) = 6.5 points; 95% confidence interval (CI) = 3.0 to 10.0,  P  = 0.001) and for Parkinson Disease Questionnaire-39 items (MD = 8.3; 95% CI = 2.7 to 13.8,  P  = 0.005) when compared to the control group post-intervention, but these were not maintained at three months post-intervention. Three themes were derived from the interviews:  Expectations versus Results, Perspectives on Treatment Contents , and  Key Factors for Success .
CONCLUSION


Patient-reported outcomes and interviews suggest that the group-based music intervention adds value to mood, alertness, and quality of life in patients with Parkinson's disease. The study does not support the efficacy in producing immediate or lasting gains in dual-tasking, cognition, balance, or freezing of gait.",2020,"The study does not support the efficacy in producing immediate or lasting gains in dual-tasking, cognition, balance, or freezing of gait.","[""Forty-six patients with Parkinson's disease"", 'Neurorehabilitation in primary care', ""patients with Parkinson's disease""]","['training with the music-based intervention, and control group ( n \u2009=\u200920) without training', 'music intervention']","['dual-task ability', ""Timed-Up-and-Go subtracting serial 7's (dual-task ability"", 'Falls Efficacy Scale', 'cognition, balance, concerns about falling, freezing of gait, and quality of life', 'mood, alertness, and quality of life', 'Parkinson Disease Questionnaire-39 items']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1719767', 'cui_str': 'Subtract - dosing instruction fragment'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.0585885,"The study does not support the efficacy in producing immediate or lasting gains in dual-tasking, cognition, balance, or freezing of gait.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Pohl', 'Affiliation': 'Department of Activity and Health, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wressle', 'Affiliation': 'Department of Acute Internal Medicine and Geriatrics, Department of Social and Welfare Studies, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Lundin', 'Affiliation': 'Department of Neurology, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Pain and Rehabilitation Centre, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Nil', 'Initials': 'N', 'LastName': 'Dizdar', 'Affiliation': 'Department of Neurology, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Clinical rehabilitation,['10.1177/0269215520907669']
191,30613471,Conducting an investigator-initiated randomized double-blinded intervention trial in acute decompensation of inborn errors of metabolism: Lessons from the N-Carbamylglutamate Consortium.,"Organic acidemias and urea cycle disorders are ultra-rare inborn errors of metabolism characterized by episodic acute decompensation, often associated with hyperammonemia, resulting in brain edema and encephalopathy. Retrospective reports and translational studies suggest that N-carbamylglutamate (NCG) may be effective in reducing ammonia levels during acute decompensation in two organic acidemias, propionic and methylmalonic acidemia (PA and MMA), and in two urea cycle disorders, carbamylphosphate synthetase 1 and ornithine transcarbamylase deficiency (CPSD and OTCD). We established the 9-site N-carbamylglutamate Consortium (NCGC) in order to conduct two randomized double-blind, placebo-controlled trials of NCG in acute hyperammonemia of PA, MMA, CPSD and OTCD. Conducting clinical trials is challenging in any disease, but poses unique barriers and risks in the ultra-rare disorders. As the number of clinical trials in orphan diseases increases, evaluating the successes and opportunities for improvement in such trials is essential. We summarize herein the design, methods, experiences, challenges and lessons from the NCGC-conducted trials.",2018,"Retrospective reports and translational studies suggest that N-carbamylglutamate (NCG) may be effective in reducing ammonia levels during acute decompensation in two organic acidemias, propionic and methylmalonic acidemia (PA and MMA), and in two urea cycle disorders, carbamylphosphate synthetase 1 and ornithine transcarbamylase deficiency (CPSD and OTCD).",[],"['N-carbamylglutamate (NCG', '9-site N-carbamylglutamate Consortium (NCGC', 'placebo', 'NCG']",[],[],"[{'cui': 'C0067889', 'cui_str': 'N-carbamoylglutamate'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],2.0,0.358205,"Retrospective reports and translational studies suggest that N-carbamylglutamate (NCG) may be effective in reducing ammonia levels during acute decompensation in two organic acidemias, propionic and methylmalonic acidemia (PA and MMA), and in two urea cycle disorders, carbamylphosphate synthetase 1 and ornithine transcarbamylase deficiency (CPSD and OTCD).","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ah Mew', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Cnaan', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McCarter', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Glass', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Rice', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Scavo', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Catherine W', 'Initials': 'CW', 'LastName': 'Gillespie', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Diaz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gerard T', 'Initials': 'GT', 'LastName': 'Berry', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': ""UCLA Mattel Children's Hospital, Los Angeles, CA, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Konczal', 'Affiliation': ""Rainbow Babies and Children's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Shawn E', 'Initials': 'SE', 'LastName': 'McCandless', 'Affiliation': ""Children's Hospital Colorado and University of Colorado Denver, Aurora, CO, USA.""}, {'ForeName': 'Curtis R', 'Initials': 'CR', 'LastName': 'Coughlin Ii', 'Affiliation': ""Children's Hospital Colorado and University of Colorado Denver, Aurora, CO, USA.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Weisfeld-Adams', 'Affiliation': ""Children's Hospital Colorado and University of Colorado Denver, Aurora, CO, USA.""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Ficicioglu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yudkoff', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Enns', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Palo Alto, CA, USA.""}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Lichter-Konecki', 'Affiliation': ""Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Gallagher', 'Affiliation': ""UCSF Benioff Children's Hospital, San Francisco, CA, USA.""}, {'ForeName': 'Mendel', 'Initials': 'M', 'LastName': 'Tuchman', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}]",Translational science of rare diseases,['10.3233/TRD-180031']
192,32282882,"IVMP+IVIG raises platelet counts faster than IVIG alone: results of a randomized, blinded trial in childhood ITP.","Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage). In such settings, the combination of IV methylprednisolone (IVMP) with IV immune globulin (IVIG) is used to rapidly increase platelet counts (PCs). However, there are no controlled data to support using combination therapy over IVIG alone. We conducted a randomized, double-blind, placebo-controlled study to evaluate the rapidity of the PC increment and associated adverse events (AEs) between 2 regimens: A (IV placebo) and B (IVMP 30 mg/kg), both given over 1 hour, followed in both cases by IVIG (Gamunex 10%) 1 g/kg over 2-3 hours in children 1-17 years old with primary ITP and PCs <20 × 109/L in whom physicians had decided to treat with IVIG. Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2 × 109/L participated. Eighteen were randomized to regimen A and 14 to regimen B. By 8 hours after initiating therapy, 55% of all children had a PC ≥20 × 109/L (no group difference). By 24 hours, mean PCs were 76.9 × 109/L (B) vs 55 × 109/L (A) (P = .06; P = .035 when adjusted for intergroup differences in patient ages). No patient experienced severe bleeding/unexpected severe AEs. There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046). Our findings show a rapid response to IVIG with/without steroids and provide evidence to support the use of IVMP+IVIG in life-threatening situations. This trial was registered at www.clinicaltrials.gov as #NCT00376077.",2020,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"['Thirty-two children (ages: median, 8 years; range, 1.2-17.5 years) with a mean baseline PC of 9.2\xa0×', 'children 1-17 years old with primary ITP and PCs <20\xa0×\xa0109/L in whom physicians had decided to treat with IVIG', 'Children with immune thrombocytopenia (ITP) rarely suffer from life-threatening bleeds (eg, intracranial hemorrhage']","['methylprednisolone (IVMP) with IV immune globulin (IVIG', 'IVMP+IVIG', 'placebo']","['platelet counts (PCs', 'rapidity of the PC increment and associated adverse events (AEs', 'IVIG-related headaches', 'severe bleeding/unexpected severe AEs', 'mean PCs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",32.0,0.385708,There were statistically fewer IVIG-related headaches in the group receiving combination therapy (P = .046).,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Carcao', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Pediatric Hematology Oncology, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Klaassen', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.""}, {'ForeName': 'MacGregor', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': ""Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada; and.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wakefield', 'Affiliation': 'Department of Nursing, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Lussia', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Victor S', 'Initials': 'VS', 'LastName': 'Blanchette', 'Affiliation': 'Division of Haematology/Oncology, Department of Paediatrics, Hospital for Sick Children and University of Toronto, Toronto, ON, Canada.'}]",Blood advances,['10.1182/bloodadvances.2019001343']
193,31423685,"Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double-blind, randomized trial.","AIMS


To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with 50 U insulin degludec (degludec) or less in Japanese individuals with type 2 diabetes (T2D).
MATERIALS AND METHODS


In this 26-week, double-blind, multicentre, treat-to-target trial, Japanese individuals with T2D that was uncontrolled with basal or pre-mix insulin (20-50 units) were randomized (1:1) to receive IDegLira or degludec, both with metformin. The maximum dose was 50 dose steps (IDegLira) or 50 units (degludec). The primary endpoint was change from baseline in HbA1c with IDegLira vs degludec after 26 weeks of treatment.
RESULTS


In total, 210 Japanese individuals were randomized to IDegLira or degludec and completion rates were 100% and 93%, respectively. IDegLira was superior to degludec with respect to change from baseline in HbA1c: estimated treatment difference (ETD) (95% confidence interval), -13.98 mmol/Mol (-16.41; -11.55); P < 0.0001. The change in mean HbA1c was from 70.6 by -21.3 mmol/Mol with IDegLira and from 70.1 by -7.1 mmol/Mol with degludec. Mean change in body weight was -0.7 kg with IDegLira and 0.7 kg with degludec: ETD (95% CI) -1.41 kg (-2.26; -0.56); P = 0.0012. Mean daily total insulin dose was significantly lower with IDegLira (37.6 U) as compared to that with degludec (41.2 U) at Week 26. Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatment groups.
CONCLUSIONS


IDegLira provided superior reductions in HbA1c compared with ≤50 U degludec, with weight loss and similar hypoglycaemia rates and no unexpected safety or tolerability issues. These results suggest that this treatment could be an attractive intensification option for Japanese subjects with T2D that was uncontrolled with basal or pre-mixed insulin.",2019,"Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatments.
","['Japanese subjects with T2D uncontrolled with basal or pre-mix insulin (20-50 units', 'Japanese subjects with type 2 diabetes (T2D', '210 Japanese subjects', 'Japanese subjects with type 2 diabetes', 'Japanese subjects with T2D uncontrolled on basal or premixed insulin']","['IDegLira or degludec both with metformin', 'Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira', 'insulin degludec/liraglutide (IDegLira', 'mmol/mol ', '≤50 U insulin degludec (degludec']","['Mean daily total insulin dose', 'weight loss and similar hypoglycaemia rates', 'Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events', 'change from baseline in HbA1c of IDegLira vs degludec', 'Mean change in body weight', 'Mean HbA1c']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",210.0,0.41885,"Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatments.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Division of Diabetes/Endocrinology/Lifestyle-related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan.'}, {'ForeName': 'Mitsuhisa', 'Initials': 'M', 'LastName': 'Komatsu', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Bue Ross', 'Initials': 'BR', 'LastName': 'Agner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Mattis', 'Initials': 'M', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13859']
194,31414562,Association between individual cholesterol and proteinuria response and exposure to atorvastatin or rosuvastatin.,"AIM


The PLANET trials showed that atorvastatin 80 mg but not rosuvastatin at either 10 or 40 mg reduced urinary protein to creatinine ratio (UPCR) at similar effects on LDL-cholesterol. However, individual changes in both UPCR and LDL-cholesterol during treatment with these statins varied widely between patients. This inter-individual variability could not be explained by patients' physical or biochemical characteristics. We assessed whether the plasma concentrations of both statins were associated with LDL-cholesterol and UPCR response.
MATERIALS AND METHODS


The PLANET trials randomized patients with a UPCR of 500-5000 mg/g and fasting LDL-cholesterol >2.33 mmol/L to a 52-week treatment with atorvastatin 80 mg, rosuvastatin 10 mg or 40 mg. For the current analysis, patients with available samples at week 52 and treatment compliance >80% by pill count were included (N = 295). The main outcome measurements were percentage change in UPCR and absolute change in LDL-cholesterol (delta LDL) from baseline to week 52.
RESULTS


Median (interquartile range) plasma concentration at week 52 for atorvastatin 80 mg was 3.9 ng/mL (IQR: 2.1 to 8.7), for rosuvastatin 10 mg 1.0 ng/mL (IQR: 0.7 to 2.0) and for rosuvastatin 40 mg 3.5 ng/mL (IQR: 2.0 to 6.8). Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52 [rosuvastatin r = -0.40 (P < .001); atorvastatin r = -0.28 (P = .006)]. The plasma concentration of both statins did not correlate with UPCR change [rosuvastatin r = 0.07 (P = .30); atorvastatin r = 0.16 (P = .13)].
CONCLUSIONS


Individual variation in plasma concentrations of rosuvastatin and atorvastatin was associated with LDL-cholesterol changes in patients. The individual variation in UPCR change was not associated with the plasma concentration of both statins.",2019,Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52,['The PLANET trials randomized patients with a UPCR of 500-5000 mg/g and fasting LDL-cholesterol >2.33\u2009mmol/l to a 52-week treatment with'],"['atorvastatin', 'atorvastatin or rosuvastatin', 'atorvastatin 80 mg, rosuvastatin 10 mg or 40 mg', 'rosuvastatin', 'rosuvastatin and atorvastatin']","['percentage change in UPCR and absolute change in LDL-cholesterol (delta LDL', 'plasma concentration', 'LDL-cholesterol reductions', 'UPCR and LDL-cholesterol', 'LDL-cholesterol and UPCR response', 'plasma concentrations', 'Median (interquartile range) plasma concentration', 'LDL-cholesterol changes', 'urinary protein to creatinine ratio (UPCR']","[{'cui': 'C0080026', 'cui_str': 'Planets'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1124482', 'cui_str': 'atorvastatin 80 MG'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0266051,Higher plasma concentration of statin was associated with larger LDL-cholesterol reductions at week 52,"[{'ForeName': 'Marjolein Y A M', 'Initials': 'MYAM', 'LastName': 'Kroonen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13849']
195,31407845,"Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naïve Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial.","AIMS


To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with its individual components in Japanese people with type 2 diabetes (T2D) uncontrolled on an oral antidiabetic drug (OAD).
MATERIALS AND METHODS


This 52-week, open-label, multicentre, treat-to-target trial randomized participants (n = 819) 1:1:1 to IDegLira, liraglutide 1.8 mg or degludec, as add-on to their pre-trial OAD. The maximum IDegLira dose was 50 dose steps (50 U degludec/1.8 mg liraglutide), there was no maximum dose for degludec, and both were titrated based on individual blood glucose measurements.
RESULTS


After 52 weeks, glycated haemoglobin (HbA1c) decreased by 26 mmol/mol with IDegLira vs 20 mmol/mol with degludec and liraglutide: estimated treatment differences were -6.91 mmol/mol (95% confidence interval [CI] -8.18; -5.64) and -5.30 mmol/mol (95% CI -6.58; -4.03), confirming non-inferiority of IDegLira to degludec and superiority of IDegLira to liraglutide (P < .0001 for both [primary endpoint]). Mean body weight changes were 2.9 kg, 4.1 kg and -1.0 kg with IDegLira, degludec and liraglutide, respectively, showing superiority of IDegLira versus degludec (P = .0001), but a significant difference in favour of liraglutide (P < .0001). Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48 [95% CI 0.35; 0.68]; P < .0001), but higher versus liraglutide (rate ratio 37.58 [95% CI 19.80; 71.31]; P < .0001). Mean daily total insulin dose was lower with IDegLira (27.7 U) versus degludec (34.8 U; P < .0001). Overall adverse event (AE) rates were similar. In total, 34.9%, 22.9% and 41.8% of IDegLira-, degludec- and liraglutide-treated participants experienced gastrointestinal AEs.
CONCLUSION


IDegLira was superior to degludec and liraglutide in terms of HbA1c reduction and superior to degludec in terms of body weight change and rates of hypoglycaemia in Japanese people with T2D.",2019,Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48,"['insulin-naïve Japanese patients with type 2 diabetes', 'Japanese people with T2D', 'Japanese people with type 2 diabetes (T2D) uncontrolled on an oral antidiabetic drug (OAD']","['IDegLira, liraglutide 1.8 mg or degludec', 'liraglutide', 'insulin degludec/liraglutide (IDegLira', 'fixed-ratio combination of insulin degludec and liraglutide (IDegLira', 'insulin degludec and liraglutide', 'mmol/mol ']","['Mean body weight changes', 'Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira', 'Mean daily total insulin dose', 'gastrointestinal AEs', 'glycated haemoglobin (HbA1c', 'body weight change and rates of hypoglycaemia', 'Overall adverse event (AE) rates']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",819.0,0.206168,Rates of severe or blood glucose-confirmed hypoglycaemia for IDegLira were lower versus degludec (rate ratio 0.48,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Tanizawa', 'Affiliation': 'Graduate School of Medicine, Yamaguchi University, Ube, Japan.'}, {'ForeName': 'Bue', 'Initials': 'B', 'LastName': 'Ross Agner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Mattis', 'Initials': 'M', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Inagaki', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13856']
196,31407856,Effects of the sodium-glucose co-transporter-2 inhibitor dapagliflozin on estimated plasma volume in patients with type 2 diabetes.,"AIMS


To compare the effects of the sodium-glucose co-transporter-2 (SGLT2) inhibitor dapagliflozin on estimated (ePV) and measured plasma volume (mPV) and to characterize the effects of dapagliflozin on ePV in a broad population of patients with type 2 diabetes.
MATERIALS AND METHODS


The Strauss formula was used to calculate changes in ePV. Change in plasma volume measured with  125  I-human serum albumin (mPV) was compared with change in ePV in 10 patients with type 2 diabetes randomized to dapagliflozin 10 mg/d or placebo. Subsequently, changes in ePV were measured in a pooled database of 13 phase 2b/3 placebo-controlled clinical trials involving 4533 patients with type 2 diabetes who were randomized to dapagliflozin 10 mg daily or matched placebo.
RESULTS


The median change in ePV was similar to the median change in mPV (-9.4% and -9.0%) during dapagliflozin treatment. In the pooled analysis of clinical trials, dapagliflozin decreased ePV by 9.6% (95% confidence interval 9.0 to 10.2) compared to placebo after 24 weeks. This effect was consistent in various patient subgroups, including subgroups with or without diuretic use or established cardiovascular disease.
CONCLUSIONS


ePV may be used as a proxy to assess changes in plasma volume during dapagliflozin treatment. Dapagliflozin consistently decreased ePV compared to placebo in a broad population of patients with type 2 diabetes.",2019,"In the pooled analysis of clinical trials, dapagliflozin compared to placebo decreased ePV by 9.6 % (95% CI: 9.0 to 10.2%) after 24 weeks.","['10 patients with type 2 diabetes randomized to', '4533 patients with type 2 diabetes', 'various patient subgroups including subgroups with or without diuretic use or established cardiovascular disease', 'patients with type 2 diabetes']","['dapagliflozin 10 mg daily or matched placebo', 'placebo', 'I-human serum albumin', 'dapagliflozin', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors']","['ePV', 'estimated plasma volume (ePV', 'plasma volume', 'estimated plasma volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}]",4533.0,0.0924018,"In the pooled analysis of clinical trials, dapagliflozin compared to placebo decreased ePV by 9.6 % (95% CI: 9.0 to 10.2%) after 24 weeks.","[{'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, Astra Zeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Cardiovascular, Renal and Metabolism Translational Medicines Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions, Raleigh, North Carolina.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, IMED Biotech Unit, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13855']
197,30834513,"A proof-of-concept, Phase 2 clinical trial of the gastrointestinal safety of a hydrogen sulfide-releasing anti-inflammatory drug.","BACKGROUND AND PURPOSE


ATB-346 is a hydrogen sulfide (H 2  S)-releasing anti-inflammatory and analgesic drug. Animal studies demonstrated negligible gastrointestinal (GI) damage despite marked inhibition of COX activity and significant analgesic and anti-inflammatory effects. In humans, ATB-346 (250 mg once daily) was found to inhibit COX to the same extent as naproxen (550 mg twice daily).
EXPERIMENTAL APPROACH


Two hundred forty-four healthy volunteers completed a 2-week, double-blind study, taking either ATB-346 (250 mg once daily) or naproxen (550 mg twice daily), with upper GI ulceration being examined endoscopically.
KEY RESULTS


Forty-two per cent of the subjects taking naproxen developed at least one ulcer (≥3-mm diameter), while only 3% of the subjects taking ATB-346 developed at least one ulcer. The two drugs produced comparable and substantial (>94%) suppression of COX activity. Subjects in the naproxen group developed more ulcers per subject than ATB-346-treated subjects and a greater incidence of larger ulcers (≥5-mm diameter). The incidence of dyspepsia, abdominal pain, gastro-oesophageal reflux, and nausea was lower with ATB-346 than with naproxen. Subjects treated with ATB-346 had significantly higher plasma levels of H 2  S than those treated with naproxen.
CONCLUSIONS AND IMPLICATIONS


This Phase 2B study provides unequivocal evidence for a marked reduction of GI toxicity of the H 2  S-releasing analgesic/anti-inflammatory drug, ATB-346, as compared to the conventional dose of naproxen that produced equivalent suppression of COX.
LINKED ARTICLES


This article is part of a themed section on Hydrogen Sulfide in Biology & Medicine. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v177.4/issuetoc.",2020,"Subjects treated with ATB-346 had significantly higher plasma levels of H 2  S than those treated with naproxen.
",['Two hundred forty-four healthy volunteers'],"['naproxen', 'hydrogen sulfide-releasing anti-inflammatory drug', 'ATB-346']","['plasma levels', 'suppression of COX activity', 'GI toxicity', 'incidence of dyspepsia, abdominal pain, gastro-oesophageal reflux, and nausea']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0887249', 'cui_str': 'Hydrogen Sulfide (H2S3)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2935222', 'cui_str': 'ATB-346'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",244.0,0.0278694,"Subjects treated with ATB-346 had significantly higher plasma levels of H 2  S than those treated with naproxen.
","[{'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Wallace', 'Affiliation': 'Department of Physiology and Pharmacology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nagy', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Troy D', 'Initials': 'TD', 'LastName': 'Feener', 'Affiliation': 'Department of Biological Sciences, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Allain', 'Affiliation': 'Department of Biological Sciences, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Ditrói', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Vaughan', 'Affiliation': 'Antibe Therapeutics Inc., Toronto, ON, Canada.'}, {'ForeName': 'Marcelo N', 'Initials': 'MN', 'LastName': 'Muscara', 'Affiliation': 'Department of Pharmacology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Nucci', 'Affiliation': 'Department of Pharmacology, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Buret', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}]",British journal of pharmacology,['10.1111/bph.14641']
198,30756475,"Treatment of internuclear ophthalmoparesis in multiple sclerosis with fampridine: A randomized double-blind, placebo-controlled cross-over trial.","AIM


To examine whether the velocity of saccadic eye movements in internuclear ophthalmoparesis (INO) improves with fampridine treatment in patients with multiple sclerosis (MS).
METHODS


Randomized, double-blind, placebo-controlled, cross-over trial with fampridine in patients with MS and INO. Horizontal saccades were recorded at baseline and at multiple time points post-dose. Main outcome measures were the change of peak velocity versional dysconjugacy index (PV-VDI) and first-pass amplitude VDI (FPA-VDI). Both parameters were compared between fampridine and placebo using a mixed model analysis of variance taking patients as their own control. Pharmacokinetics was determined by serial blood sampling.
RESULTS


Thirteen patients had a bilateral and 10 had a unilateral INO. One patient had an INO of abduction (posterior INO of Lutz) and was excluded. Fampridine significantly reduced both PV-VDI (-17.4%, 95% CI: -22.4%, -12.1%; P < 0.0001) and FPA-VDI (-12.5%, 95% CI: -18.9%, -5.5%; P < 0.01). Pharmacokinetics demonstrated that testing coincided with the average t max  at 2.08 hours (SD 45 minutes). The main adverse event reported after administration of fampridine was dizziness (61%).
CONCLUSION


Fampridine improves saccadic eye movements due to INO in MS. Treatment response to fampridine may gauge patient selection for inclusion to remyelination strategies in MS using saccadic eye movements as primary outcome measure.",2019,"Fampridine significantly reduced both PV-VDI (-17.4%, 95% CI: -22.4%, -12.1%; P < 0.0001) and FPA-VDI (-12.5%, 95% CI: -18.9%, -5.5%; P < 0.01).","['Thirteen patients had a bilateral and 10 had a unilateral INO', 'multiple sclerosis with fampridine', 'patients with multiple sclerosis (MS', 'patients with MS and INO']","['Fampridine', 'placebo', 'fampridine', 'fampridine treatment', 'fampridine and placebo']","['saccadic eye movements', 'change of peak velocity versional dysconjugacy index (PV-VDI) and first-pass amplitude VDI (FPA-VDI', 'FPA-VDI', 'INO of abduction (posterior INO of Lutz', 'Horizontal saccades', 'PV-VDI', 'dizziness']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0000477', 'cui_str': 'fampridine'}]","[{'cui': 'C0000477', 'cui_str': 'fampridine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",,0.536121,"Fampridine significantly reduced both PV-VDI (-17.4%, 95% CI: -22.4%, -12.1%; P < 0.0001) and FPA-VDI (-12.5%, 95% CI: -18.9%, -5.5%; P < 0.01).","[{'ForeName': 'Kawita M S', 'Initials': 'KMS', 'LastName': 'Kanhai', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Nij Bijvank', 'Affiliation': 'Department of Ophthalmology, Neuro-ophthalmology Expertise Center, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yorick L', 'Initials': 'YL', 'LastName': 'Wagenaar', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'KyoungSoo', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Sandrin C', 'Initials': 'SC', 'LastName': 'Bergheanu', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Petzold', 'Affiliation': 'Department of Ophthalmology, Neuro-ophthalmology Expertise Center, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Experimental Medicine, Biogen, Cambridge, Massachusetts.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hesterman', 'Affiliation': 'inviCRO, Boston, Massachusetts.'}, {'ForeName': 'Mike P', 'Initials': 'MP', 'LastName': 'Wattjes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': 'Department of Neurology, MS Center and Neuro-ophthalmology Expertise Center, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Laurentius J', 'Initials': 'LJ', 'LastName': 'van Rijn', 'Affiliation': 'Department of Ophthalmology, Neuro-ophthalmology Expertise Center, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13096']
199,30702173,Randomized controlled single-blinded clinical trial of functional voice outcome after vascular targeting KTP laser microsurgery of early laryngeal cancer.,"BACKGROUND


Local control rate (LCR) of early glottic cancer is high after radiation therapy or transoral laser microsurgery (TLM). The aim of this study was to investigate functional voice outcome after TLM using a microvessel-ablative potassium-titanyl-phosphate (KTP) laser in comparison with a gold standard cutting CO 2  laser.
METHODS


The primary end point of this prospective, randomized, single-blinded, clinical phase II study with control group was voice outcome during a follow-up of 6 months assayed by Voice Handicap Index (VHI-30)-questionnaires in patients with unilateral high-grade dysplasia, carcinoma in situ or early glottic cancer undergoing TLM-KTP (n = 8) or TLM-CO 2  (n = 12). The secondary end point was LCR.
RESULTS


Starting from the 9-week-follow-up visit, TLM-KTP yielded significantly reduced VHI scores compared to TLM-CO 2  . No relapse occurred after TLM-KTP in contrast to one recurrence after TLM-CO 2  within 6 months.
CONCLUSION


Multicenter phase II or III studies on voice outcome or local control rate after TLM-KTP in early glottic cancer are warranted enrolling larger patient cohorts.",2019,"Starting from the 9-week-follow-up visit, TLM-KTP yielded significantly reduced VHI scores compared to TLM-CO 2  .","['patients with unilateral high-grade dysplasia, carcinoma in situ or early glottic cancer undergoing TLM-KTP (n\u2009=\u20098) or TLM-CO 2  (n\u2009=\u200912', 'early glottic cancer', 'early laryngeal cancer']","['TLM using a microvessel-ablative potassium-titanyl-phosphate (KTP) laser', 'vascular targeting KTP laser', 'TLM-KTP', 'radiation therapy or transoral laser microsurgery (TLM']","['functional voice outcome', 'Voice Handicap Index', 'voice outcome or local control rate', 'VHI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma, Intraepithelial'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007107', 'cui_str': 'Cancer of Larynx'}]","[{'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0392222', 'cui_str': 'Potassium Titanyl Phosphate Lasers'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0439888,"Starting from the 9-week-follow-up visit, TLM-KTP yielded significantly reduced VHI scores compared to TLM-CO 2  .","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Strieth', 'Affiliation': 'Department of Otorhinolaryngology-Section of Head and Neck Surgery, Goethe-University Medical Center, Frankfurt/Main, Germany.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Ernst', 'Affiliation': 'Department of Otorhinolaryngology-Section of Head and Neck Surgery, Goethe-University Medical Center, Frankfurt/Main, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Both', 'Affiliation': 'Department of Otorhinolaryngology-Section of Head and Neck Surgery, Goethe-University Medical Center, Frankfurt/Main, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hirth', 'Affiliation': 'Department of Otorhinolaryngology-Section of Phoniatrics, Goethe-University Medical Center, Frankfurt/Main, Germany.'}, {'ForeName': 'Lara N', 'Initials': 'LN', 'LastName': 'Pfisterer', 'Affiliation': 'Department of Otorhinolaryngology-Section of Phoniatrics, Goethe-University Medical Center, Frankfurt/Main, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Künzel', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Johannes Gutenberg-University Medical Center, Mainz, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Eder', 'Affiliation': 'Department of Otorhinolaryngology-Section of Phoniatrics, Ludwig-Maximilians-University Medical Center, Munich, Germany.'}]",Head & neck,['10.1002/hed.25474']
200,31642066,The Wellness Incentive and Navigation intervention improved health-related quality of life among Medicaid enrollees: A randomized pragmatic clinical trial.,"OBJECTIVE


To examine whether the Wellness Incentive and Navigation (WIN) intervention can improve health-related quality of life (HRQOL) among Medicaid enrollees with co-occurring physical and behavioral health conditions.
DATA SOURCES


Annual telephone survey data from 2013 to 2016, linked with claims data.
STUDY DESIGN


We recruited 1259 participants from the Texas STAR + PLUS managed care program and randomized them into an intervention group that received flexible wellness accounts and navigator services or a control group that received standard care. We conducted 4 waves of telephone surveys to collect data on HRQOL, patient activation, and other participant demographic and clinical characteristics.
DATA COLLECTION/EXTRACTION METHODS


The 3M Clinical Risk Grouping Software was used to extract variables from claims data and group participants based on disease severity.
PRINCIPAL FINDINGS


Our results showed that the WIN intervention was effective in increasing patient activation and HRQOL among Medicaid enrollees with co-occurring physical and behavioral health conditions. Furthermore, we found that this intervention effect on HRQOL was partially mediated by patient activation.
CONCLUSIONS


Providing navigator support with wellness account is effective in improving HRQOL among Medicaid enrollees. The pragmatic nature of the trial maximizes the chance of successfully implementing it in state Medicaid programs.",2019,Our results showed that the WIN intervention was effective in increasing patient activation and HRQOL among Medicaid enrollees with co-occurring physical and behavioral health conditions.,"['Annual telephone survey data from 2013 to 2016, linked with claims data', '1259 participants from the Texas STAR\xa0+\xa0PLUS managed care program', 'Medicaid enrollees with co-occurring physical and behavioral health conditions', 'Medicaid enrollees']","['flexible wellness accounts and navigator services or a control group that received standard care', 'Wellness Incentive and Navigation intervention', 'Wellness Incentive and Navigation (WIN) intervention']","['HRQOL', 'health-related quality of life', 'health-related quality of life (HRQOL', 'patient activation and HRQOL']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024679', 'cui_str': 'Managed Health Care Insurance Plans'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",1259.0,0.0617376,Our results showed that the WIN intervention was effective in increasing patient activation and HRQOL among Medicaid enrollees with co-occurring physical and behavioral health conditions.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Walter Bruce', 'Initials': 'WB', 'LastName': 'Vogel', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Muller', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Stoner', 'Affiliation': 'Behavioral Health Services, Texas Health and Human Services, Austin, Texas.'}, {'ForeName': 'Tianyao', 'Initials': 'T', 'LastName': 'Huo', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Shenkman', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida.'}]",Health services research,['10.1111/1475-6773.13235']
201,32145279,"Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial.","OBJECTIVE


To investigate the feasibility and benefits of whole-body vibration (WBV) exercise as a safe and effective training tool for countering sarcopenia and age-related declines in mobility and function in the frail elderly.
DESIGN


An open, randomized controlled trial.
SETTING


Residential care facilities.
PARTICIPANTS


Male and female volunteers (N=117; 82.5±7.9y).
INTERVENTIONS


After prescreening for contraindications, participants were randomly allocated to a control, simulated WBV (SIM), or WBV exercise group. All participants received regular care, whereas WBV and SIM participants also underwent thrice-weekly exercise sessions for 16 weeks. Delivered by overload principle, WBV training began with 5 × 1-minute bouts at 6 Hz/2 mm (1:1 min exercise:rest), progressing to 10 × 1 minute at up to 26 Hz/4 mm, maintaining knee flexion. Training for SIM participants mimicked WBV exercise stance and duration only.
MAIN OUTCOME MEASURES


The timed Up and Go, Parallel Walk, and 10-m Timed Walk (10mTW) tests performance were assessed, in addition to the Barthel Index Questionnaire, at baseline, 8, and 16 weeks of exercise, and 3, 6, and 12 months postexercise.
RESULTS


High levels of compliance were reported in SIM (89%) and WBV training (93%), with ease of use and no adverse effects. In comparison to baseline levels, WBV training elicited clinically important treatment effects in all parameters compared to SIM and control groups. Treatment effects remained apparent up to 12 months postintervention for Parallel Walk Test and 6 months for 10mTW Test. Functional test performance declined during and postintervention in non-WBV groups.
CONCLUSIONS


Findings indicate that 16 weeks of low-level WBV exercise provides easily accessible, adequate stimulus for the frail elderly to attain improved levels of physical functionality.",2020,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,['Residential care-facilities PARTICIPANTS: 117 male and female volunteers (82.5 ± 7.9 years'],"['Control (CON), Simulated-WBV (SIM) or WBV-exercise (WBV) group', 'Whole Body Vibration (WBV) exercise', 'regular care, whilst WBV- and SIM- participants also underwent thrice-weekly exercise sessions']","['WBV-exercise stance', 'Timed-Up-and-Go, Parallel Walk and 10-m Timed-Walk test performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",117.0,0.0407411,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wadsworth', 'Affiliation': 'School of Sport & Exercise, Massey University, New Zealand; School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Australia. Electronic address: dwadswor@usc.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lark', 'Affiliation': 'Sport and Exercise New Zealand, Christchurch, New Zealand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.009']
202,31645286,"Anaesthetic depth and complications after major surgery: an international, randomised controlled trial.","BACKGROUND


An association between increasing anaesthetic depth and decreased postoperative survival has been shown in observational studies; however, evidence from randomised controlled trials is lacking. Our aim was to compare all-cause 1-year mortality in older patients having major surgery and randomly assigned to light or deep general anaesthesia.
METHODS


In an international trial, we recruited patients from 73 centres in seven countries who were aged 60 years and older, with significant comorbidity, having surgery with expected duration of more than 2 h, and an anticipated hospital stay of at least 2 days. We randomly assigned patients who had increased risk of complications after major surgery to receive light general anaesthesia (bispectral index [BIS] target 50) or deep general anaesthesia (BIS target 35). Anaesthetists also nominated an appropriate range for mean arterial pressure for each patient during surgery. Patients were randomly assigned in permuted blocks by region immediately before surgery, with the patient and assessors masked to group allocation. The primary outcome was 1-year all-cause mortality. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12612000632897, and is closed to accrual.
FINDINGS


Patients were enrolled between Dec 19, 2012, and Dec 12, 2017. Of the 18 026 patients screened as eligible, 6644 were enrolled, randomly assigned to treatment or control, and formed the intention-to-treat population (3316 in the BIS 50 group and 3328 in the BIS 35 group). The median BIS was 47·2 (IQR 43·7 to 50·5) in the BIS 50 group and 38·8 (36·3 to 42·4) in the BIS 35 group. Mean arterial pressure was 3·5 mm Hg (4%) higher (median 84·5 [IQR 78·0 to 91·3] and 81·0 [75·4 to 87·6], respectively) and volatile anaesthetic use was 0·26 minimum alveolar concentration (30%) lower (0·62 [0·52 to 0·73] and 0·88 [0·74 to 1·04], respectively) in the BIS 50 than the BIS 35 group. 1-year mortality was 6·5% (212 patients) in the BIS 50 group and 7·2% (238 patients) in the BIS 35 group (hazard ratio 0·88, 95% CI 0·73 to 1·07, absolute risk reduction 0·8%, 95% CI -0·5 to 2·0). Grade 3 adverse events occurred in 954 (29%) patients in the BIS 50 group and 909 (27%) patients in the BIS 35 group; and grade 4 adverse events in 265 (8%) and 259 (8%) patients, respectively. The most commonly reported adverse events were infections, vascular disorders, cardiac disorders, and neoplasms.
INTERPRETATION


Among patients at increased risk of complications after major surgery, light general anaesthesia was not associated with lower 1-year mortality than deep general anaesthesia. Our trial defines a broad range of anaesthetic depth over which anaesthesia may be safely delivered when titrating volatile anaesthetic concentrations using a processed electroencephalographic monitor.
FUNDING


Health Research Council of New Zealand; National Health and Medical Research Council, Australia; Research Grant Council of Hong Kong; National Institute for Health and Research, UK; and National Institutes of Health, USA.",2019,"Among patients at increased risk of complications after major surgery, light general anaesthesia was not associated with lower 1-year mortality than deep general anaesthesia.","['Of the 18\u2008026 patients screened as eligible, 6644 were enrolled', 'after major surgery', 'recruited patients from 73 centres in seven countries who were aged 60 years and older, with significant comorbidity, having surgery with expected duration of more than 2 h, and an anticipated hospital stay of at least 2 days', 'Patients were enrolled between Dec 19, 2012, and Dec 12, 2017', 'older patients having major surgery', 'patients who had increased risk of complications after major surgery to receive']","['light or deep general anaesthesia', 'light general anaesthesia (bispectral index [BIS] target 50) or deep general anaesthesia (BIS target 35']","['mean arterial pressure', 'Grade 3 adverse events', 'Mean arterial pressure', 'Anaesthetic depth and complications', '1-year mortality', 'adverse events were infections, vascular disorders, cardiac disorders, and neoplasms', 'risk of complications', '1-year all-cause mortality', 'grade 4 adverse events', 'median BIS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",50.0,0.275794,"Among patients at increased risk of complications after major surgery, light general anaesthesia was not associated with lower 1-year mortality than deep general anaesthesia.","[{'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Short', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand; University of Auckland, Auckland, New Zealand. Electronic address: tims@adhb.govt.nz.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand; University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': 'Chinese University of Hong Kong, Hong Kong Special Administrative Area, China.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Alfred Hospital, Melbourne, VIC, Australia; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Tomás B', 'Initials': 'TB', 'LastName': 'Corcoran', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Royal Perth Hospital and University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Mills', 'Affiliation': 'Sheffield Teaching Hospitals and University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Cata', 'Affiliation': 'University of Texas and MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Painter', 'Affiliation': 'Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Waikato Hospital, Waikato, New Zealand.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Beijing Tiantan Hospital and Capital Medical University, Beijing, China.'}, {'ForeName': 'Mandy H M', 'Initials': 'MHM', 'LastName': 'Chu', 'Affiliation': 'Pamela Youde Nethersole Eastern Hospital, Hong Kong Special Administrative Area, China.'}, {'ForeName': 'Davina J', 'Initials': 'DJ', 'LastName': 'McAllister', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Royal Melbourne Hospital and University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32315-3']
203,31813087,Matching-Adjusted Indirect Comparison of Health-Related Quality of Life and Adverse Events of Apalutamide Versus Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer.,"INTRODUCTION


The present study aimed to indirectly compare apalutamide and enzalutamide with respect to tolerability and health-related quality of life (HRQoL) among men with non-metastatic castration-resistant prostate cancer (nmCRPC).
METHODS


Patient-level data from the SPARTAN study [apalutamide + androgen deprivation therapy (ADT) versus placebo + ADT] and aggregate published data from the PROSPER study (enzalutamide + ADT versus placebo + ADT) were used. Anchored matching-adjusted indirect comparison (MAIC) was conducted by weighting patients' baseline characteristics from SPARTAN to match aggregated baseline characteristics in PROSPER. Odds ratios (ORs) of reported adverse events (AEs) and baseline-to-follow-up least squares mean differences in HRQoL [measured with Functional Assessment of Cancer Therapy-Prostate (FACT-P) score] with 95% credible intervals were re-estimated for SPARTAN arms using weighted population and indirectly compared with those in PROSPER through a Bayesian framework. Events of special interest included fatigue, hot flush, nausea, diarrhea, hypertension, falls, dizziness, decreased appetite, arthralgia, asthenia and headache. In addition, any AEs and serious AEs were explored.
RESULTS


Of 1207 SPARTAN patients, 1171 were matched to 1401 PROSPER patients. Relative to enzalutamide, apalutamide demonstrated better tolerability as evidenced by the highest probability of reduced occurrence of fatigue [p(OR < 1) = 99.5%], hypertension [p(OR < 1) = 99.2%], decreased appetite [p(OR < 1) = 98.3%], fall [p(OR < 1) = 90.3%], headaches [p(OR < 1) = 86.7%], and nausea [p(OR < 1) = 80.0%]. The probabilities of reduced occurrence of any AEs and SAEs with apalutamide versus enzalutamide were 66.9% and 90.9%, respectively. Relative to enzalutamide, apalutamide treatment was associated with a higher probability of a better HRQoL based on the FACT-P total score [p(diff > 0) = 73.1%]. The probability of a better HRQoL with apalutamide versus enzalutamide was highest for the physical [p(diff > 0) = 97.3%] and functional [p(diff > 0) = 86.7%] wellbeing subscales, and the pain-related subscale [p(diff > 0) = 90.1%].
CONCLUSION


Anchored MAIC suggests that treatment of men with nmCRPC with apalutamide is associated with a higher probability of better tolerability due to fewer AEs and better HRQoL than enzalutamide.",2020,"Relative to enzalutamide, apalutamide demonstrated better tolerability as evidenced by the highest probability of reduced occurrence of fatigue [p(OR < 1) = 99.5%], hypertension [p(OR < 1) = 99.2%], decreased appetite [p(OR < 1) = 98.3%], fall [p(OR < 1) = 90.3%], headaches [p(OR < 1) = 86.7%], and nausea [p(OR < 1) = 80.0%].","['men with non-metastatic castration-resistant prostate cancer (nmCRPC', 'Patient-level data from the SPARTAN study ', 'Non-Metastatic Castration-Resistant Prostate Cancer', 'Of 1207 SPARTAN patients, 1171 were matched to 1401 PROSPER patients']","['apalutamide and enzalutamide', 'apalutamide\u2009+\u2009androgen deprivation therapy (ADT) versus placebo\u2009+\u2009ADT', 'enzalutamide\u2009+\u2009ADT versus placebo\u2009+\u2009ADT']","['hypertension', 'headaches', 'decreased appetite', 'Odds ratios (ORs) of reported adverse events (AEs) and baseline-to-follow-up least squares mean differences in HRQoL [measured with Functional Assessment of Cancer Therapy-Prostate (FACT-P) score', 'nausea', 'tolerability and health-related quality of life (HRQoL', 'fatigue, hot flush, nausea, diarrhea, hypertension, falls, dizziness, decreased appetite, arthralgia, asthenia and headache']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",1171.0,0.080166,"Relative to enzalutamide, apalutamide demonstrated better tolerability as evidenced by the highest probability of reduced occurrence of fatigue [p(OR < 1) = 99.5%], hypertension [p(OR < 1) = 99.2%], decreased appetite [p(OR < 1) = 98.3%], fall [p(OR < 1) = 90.3%], headaches [p(OR < 1) = 86.7%], and nausea [p(OR < 1) = 80.0%].","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Department of Medical Oncology, Guy's, King's, and St. Thomas' Hospital, London, UK. simon.chowdhury@gstt.nhs.uk.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'European Georges Pompidou Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Pilon', 'Affiliation': 'Analysis Group, Inc., Montréal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lefebvre', 'Affiliation': 'Analysis Group, Inc., Montréal, QC, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McQuarrie', 'Affiliation': 'Janssen Research & Development, Horsham, PA, USA.'}, {'ForeName': 'Jinan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Janssen Research & Development, Horsham, PA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Dearden', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Sermon', 'Affiliation': 'Janssen EMEA, Beerse, Belgium.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Van Sanden', 'Affiliation': 'Janssen EMEA, Beerse, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Diels', 'Affiliation': 'Janssen EMEA, Beerse, Belgium.'}, {'ForeName': 'Boris A', 'Initials': 'BA', 'LastName': 'Hadaschik', 'Affiliation': 'University of Duisburg-Essen and German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Essen, Germany.'}]",Advances in therapy,['10.1007/s12325-019-01157-4']
204,31965579,Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.,"BACKGROUND AND AIMS


Emerging data from a single-center study suggests that a 30% relative reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline may be associated with histologic improvement in nonalcoholic steatohepatitis (NASH). There are limited multicenter data comparing an active drug versus placebo on the association between the quantity of liver fat reduction assessed by MRI-PDFF and histologic response in NASH. This study aims to examine the association between 30% relative reduction in MRI-PDFF and histologic response in obeticholic acid (OCA) versus placebo-treated patients in the FLINT (farnesoid X receptor ligand obeticholic acid in NASH trial).
APPROACH AND RESULTS


This is a secondary analysis of the FLINT trial including 78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment. Histologic response was defined as a 2-point improvement in nonalcoholic fatty liver disease activity score without worsening of fibrosis. OCA (25 mg orally once daily) was better than placebo in improving MRI-PDFF by an absolute difference of -3.4% (95% confidence interval [CI], -6.5 to -0.2%, P value = 0.04) and relative difference of -17% (95% CI, -34 to 0%, P value = 0.05). The optimal cutoff point for relative decline in MRI-PDFF for histologic response was 30% (using Youden's index). The rate of histologic response in those who achieved less than 30% decline in MRI-PDFF versus those who achieved a 30% or greater decline in MRI-PDFF (MRI-PDFF responders) relative to baseline was 19% versus 50%, respectively. Compared with MRI-PDFF nonresponders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, P value < 0.009) of histologic response, including significant improvements in both steatosis and ballooning.
CONCLUSION


OCA was better than placebo in reducing liver fat. This multicenter trial provides data regarding the association between 30% decline in MRI-PDFF relative to baseline and histologic response in NASH.",2020,"Compared to MRI-PDFF non-responders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, p-value <0.009) of histologic response including significant improvements in both steatosis and ballooning.
","['treated patients in the FLINT trial', 'nonalcoholic steatohepatitis', '78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment']","['placebo', 'obeticholic acid versus placebo', 'Obeticholic acid']","['Histologic response', 'MRI-PDFF', 'NAFLD Activity Score', 'MRI-PDFF and histologic response', 'rate of histologic response']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0303753', 'cui_str': 'Flintstone'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.29775,"Compared to MRI-PDFF non-responders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4-12.8, p-value <0.009) of histologic response including significant improvements in both steatosis and ballooning.
","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Indiana University, Indianapolis, IN.'}, {'ForeName': 'Anna Mae', 'Initials': 'AM', 'LastName': 'Diehl', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Terrault', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kowdley', 'Affiliation': 'Liver Center, Department of Medicine, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, The National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Behling', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Department of Pediatrics, Columbia University, New York, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Van Natta', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Middleton', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Sirlin', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology and Hepatology Department of Medicine, University of California San Diego, La Jolla, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31121']
205,32297279,Feasibility and Outcome of a Phase II Study of Intensive Induction Chemotherapy in 91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment.,"INTRODUCTION


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


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


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


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


The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.",2020,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","['149 patients with acute myeloid leukaemia (AML) aged ≥', '91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment', 'Ninety-one fully or partially fit patients (61', 'and 58 (39%) frail patients to best supportive care (BSC']","['Intensive Induction Chemotherapy', 'MGA', 'intensive chemotherapy', 'aracytin and idarubicin plus amifostine']","['8-year overall survival (OS', 'early death and complete response (CR) rate']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",149.0,0.066301,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Capelli', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy. debora.capelli@ospedaliriuniti.marche.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saraceni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Chiarucci', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Menotti', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Poloni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Discepoli', 'Affiliation': 'Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Olivieri', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01310-4']
206,32297653,Transmuscular quadratus lumborum block for percutaneous nephrolithotomy: Study protocol for a dose-finding trial.,"BACKGROUND


The objective of this trial is to optimize the transmuscular quadratus lumborum (TQL) block, by investigating the minimal effective volume (MEV 90  ) of ropivacaine 0.75% for single-shot TQL block in percutaneous nephrolithotomy (PNL) patients.
METHODS


This double-blind, randomized and controlled dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anaesthetic administered to each patient depends on the response from the previous one. Investigating the TQL block, the first patient recruited receives 20 ml ropivacaine 0.75% preoperatively. In case of block failure, the next patient will receive the same volume with an increment of 2 ml. Given a successful block for the first patient, the next patient will be randomized to either a lower volume (previous volume with a reduction of 2 ml), or the same volume as the previous patient. The respective probabilities being b = 0.11 for a reduced volume and 1-b = 0.89 for the same volume. Block success is defined as patient reported pain score numeric rated scale (NRS) ≤3 (0-10/10) 30 minutes after arrival in the post anaesthesia care unit (PACU). The NRS pain score is our primary and only outcome for block success. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV 90  with narrow 95% confidence intervals derived by bootstrapping.
DISCUSSION


Recruiting will begin June 2020 and is expected to finish November 2020. Data analysis will be performed at interims during and after the study. Results will be published in an international peer-reviewed medical journal.",2020,The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume.,"['25 eligible patients', 'percutaneous nephrolithotomy (PNL) patients']",['ropivacaine'],"['NRS pain score', 'pain score numeric rated scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.09871,The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume.,"[{'ForeName': 'Christian H S', 'Initials': 'CHS', 'LastName': 'Andersen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Gunnar H', 'Initials': 'GH', 'LastName': 'Laier', 'Affiliation': 'Production, Research and Innovation, Region Sjaelland, Soro, Denmark.'}, {'ForeName': 'Martin V', 'Initials': 'MV', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Dam', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Hansen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Tanggaard', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Børglum', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13605']
207,31782131,Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol.,"INTRODUCTION


Incontinence (up to 20%) and erectile dysfunction (up to 70%) occur frequently after radical prostatectomy (RP) in patients with localized prostate cancer. Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance. Preliminary studies showed the potential value of HAM in the reconstruction of the urinary tract and nerve protection during RP.
METHODS


A protocol is developed for a prospective, randomized, single-blind, single-surgeon, placebo-controlled exploration study of the efficacy and safety of dehydrated human amnion membrane placed around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RP for the treatment of localized prostate cancer. Eligible for inclusion are patients with localized prostate cancer, requiring a surgical procedure and exclusion of preoperative incontinence and erectile dysfunction. The patients are randomized 1:1 to HAM vs. placebo and blinded during the study period. According to the T test with an alpha of 0.05 and a power of 80% and expecting a dropout of 20% of the patients, an adjusted sample size per arm of 164 patients is required.
PLANNED OUTCOMES


The primary outcome is a postoperative continence measured as 24-h pad test up to 12 months postoperatively. Secondary outcomes are potency, time of postoperative catheter removal, postoperative complications, and biochemical recurrence. The protocol for this randomized exploration study defines the conditions to assess the efficacy and safety of HAM application during RP in order to improve the postoperative functional outcome. This trial should pave the way for future studies of tissue engineering in an effort to reduce the morbidity of RP.
TRIAL REGISTRATION


Clinicaltrials.gov, identifier NCT03864939.",2020,Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance.,"['localized prostate cancer', 'patients with localized prostate cancer, requiring a surgical procedure and exclusion of preoperative incontinence and erectile dysfunction', 'patients with localized prostate cancer']","['HAM', 'HAM vs. placebo', 'dehydrated human amnion membrane placed around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA', 'radical prostatectomy (RP', 'placebo', 'Human amniotic membrane (HAM', 'Dried Human Amnion Graft']","['Post-Prostatectomy Incontinence and Potency', 'potency, time of postoperative catheter removal, postoperative complications, and biochemical recurrence', 'postoperative continence measured as 24-h pad test', 'erectile dysfunction']","[{'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002630', 'cui_str': 'Amniotic Membrane'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C3160824', 'cui_str': 'Vesicourethral anastomosis'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]",164.0,0.0605223,Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance.,"[{'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Barski', 'Affiliation': 'Department of Urology, Rhineland Clinic, Lukas Hospital Neuss, Preussenstr. 84, 41464, Neuss, Germany. dimitri.barski@rheinlandklinikum.de.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Gerullis', 'Affiliation': 'University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Ecke', 'Affiliation': 'Department of Urology, HELIOS Hospital, Bad Saarow, Germany.'}, {'ForeName': 'Mihaly', 'Initials': 'M', 'LastName': 'Boros', 'Affiliation': 'Department of Experimental Surgery, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brune', 'Affiliation': 'DIZG, Deutsches Institut für Zell- und Gewebeersatz gGmbH, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beutner', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Tsaur', 'Affiliation': 'Department for Urology and Pediatric Urology, University Medical Center of Johannes Gutenberg, Mainz, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Ramon', 'Affiliation': 'International Tissue Engineering Research Association (ITERA), Antwerp, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Otto', 'Affiliation': 'Department of Urology, Rhineland Clinic, Lukas Hospital Neuss, Preussenstr. 84, 41464, Neuss, Germany.'}]",Advances in therapy,['10.1007/s12325-019-01158-3']
208,32297095,Using Complier Average Causal Effect Estimation to Examine Student Outcomes of the PAX Good Behavior Game When Integrated with the PATHS Curriculum.,"A growing body of research has documented a link between variation in implementation dosage and outcomes associated with preventive interventions. Complier Average Causal Effect (CACE; Jo in J Educ Behav Stat 27:385-409, 2002) analysis allows for estimating program impacts in light of variation in implementation. This study reports intent-to-treat (ITT) and CACE findings from a randomized controlled trial (RCT) testing the impacts of the universal PAX Good Behavior Game (PAX GBG) integrated with Promoting Alternative Thinking Strategies (i.e., PATHS to PAX) and PAX GBG only compared to a control. This study used ratings by 318 K-5 teachers of 1526 at-risk children who, at baseline, were rated as displaying the top 33rd percentile of aggressive-disruptive behavior. Leveraging a prior study on these data (Berg et al. in Admin Policy Ment Health Ment Health Serv Res 44:558-571, https://doi.org/10.1007/s10488-016-0738-1 , 2017), CACE was defined as the effect of intervention assignment for compliers, using two compliance cut points (50th and 75th percentile), on posttest ratings of student academic engagement, social competence, peer relations, emotion regulation, hyperactivity, and aggressive-disruptive behavior. The ITT analyses indicated improvements for students in the integrated condition on ratings of social competence compared to the control condition. The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms. These findings illustrate the importance of considering variation in implementation within the context of RCTs.",2020,"The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms.","['318\xa0K-5 teachers of 1526 at-risk children who, at baseline, were rated as displaying the top 33rd percentile of aggressive-disruptive behavior']","['PAX Good Behavior Game', 'universal PAX Good Behavior Game (PAX GBG']","['ratings of social competence', 'academic engagement and emotion regulation', 'social competence', 'posttest ratings of student academic engagement, social competence, peer relations, emotion regulation, hyperactivity, and aggressive-disruptive behavior']","[{'cui': 'C0108311', 'cui_str': 'capsular polysaccharide K5'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]",,0.0153983,"The CACE analyses also indicated significant effects of the integrated intervention on social competence, as well as academic engagement and emotion regulation for students in high compliance classrooms.","[{'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bradshaw', 'Affiliation': 'Curry School of Education and Human Development, University of Virginia, Charlottesville, VA, USA. cpb8g@virginia.edu.'}, {'ForeName': 'Kathan D', 'Initials': 'KD', 'LastName': 'Shukla', 'Affiliation': 'Indian Institute of Management, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Elise T', 'Initials': 'ET', 'LastName': 'Pas', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Juliette K', 'Initials': 'JK', 'LastName': 'Berg', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Ialongo', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01034-1']
209,31385425,IDegLira improves patient-reported outcomes while using a simple regimen with fewer injections and dose adjustments compared with basal-bolus therapy.,"AIMS


Basal-bolus therapy is associated with greater treatment burden and lower adherence compared with more simplified regimens. This post hoc analysis studied the difference between insulin degludec/liraglutide (IDegLira) and basal-bolus therapy on number of injections, dose adjustments and patient outcomes in the DUAL VII trial.
MATERIALS AND METHODS


DUAL VII was a 26-week, open-label trial in which patients with uncontrolled type 2 diabetes who were using metformin and insulin glargine 100 units/mL (20-50 U) were randomized 1:1 to IDegLira (N = 252) or basal-bolus (insulin glargine U100 + insulin aspart ≤4 times/day) (N = 254). This post hoc analysis reports the observed mean number of injections and cumulative dose adjustments during 26 weeks of treatment. Patient-reported outcomes (Treatment-Related Impact Measure - Diabetes [TRIM-D] and Short Form-36 Health Survey version 2 [SF-36v2]) were collected at scheduled visits and change from baseline scores calculated.
RESULTS


The clinical benefits (non-inferior HbA1c reductions, weight benefit, less hypoglycaemia) of IDegLira vs basal-bolus therapy were achieved with fewer cumulative dose adjustments (16.6 vs 217.2, respectively) and fewer injections (1 vs ≥3 per day, respectively). Patients treated with IDegLira experienced significant improvements across all TRIM-D domains compared with those undergoing basal-bolus therapy. The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
CONCLUSIONS


These findings, combined with the DUAL VII results, suggest that IDegLira, through a more simplified regimen versus basal-bolus therapy, may help improve patient adherence and improve patient outcomes related to diabetes management, treatment burden and mental health, which in turn may assist in the timely achievement of glycaemic control in clinical practice.",2019,"The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
","['patients with uncontrolled type 2 diabetes who were using', '100\u2009units/mL (20-50\u2009U']","['IDegLira (N = 252) or basal-bolus (insulin glargine U100\u2009+\u2009insulin aspart ≤4 times/day', 'metformin and insulin glargine']","['weight benefit, less hypoglycaemia', 'Patient-reported outcomes (Treatment-Related Impact Measure - Diabetes [TRIM-D] and Short Form-36 Health Survey', 'TRIM-D domains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439511', 'cui_str': 'times/day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.087714,"The SF-36v2 showed improvements in both treatment arms with no significant difference between arms in the physical component summary, but there was a significant improvement in patients treated with IDegLira in the mental component summary (P = .0228).
","[{'ForeName': 'Eden', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation, Bend, Oregon.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'PrimeCare Medical Group, Houston, Texas.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Grøn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Jódar', 'Affiliation': 'University Hospital Quiron Salud, Madrid, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mattis F', 'Initials': 'MF', 'LastName': 'Ranthe', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, Illinois.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Tentolouris', 'Affiliation': 'Laiko General Hospital, Medical School, National and Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Centre, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Liana K', 'Initials': 'LK', 'LastName': 'Billings', 'Affiliation': 'Internal Medicine, NorthShore University HealthSystem, Skokie, Illinois.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13851']
210,31792945,"First-line R-CVP versus R-CHOP induction immunochemotherapy for indolent lymphoma with rituximab maintenance. A multicentre, phase III randomized study by the Polish Lymphoma Research Group PLRG4.","R-CVP (cyclophosphamide, vincristine, prednisone) and R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone + rituximab) are immunochemotherapy regimens frequently used for remission induction of indolent non-Hodgkin lymphomas (iNHLs). Rituximab maintenance (RM) significantly improves progression-free survival (PFS) in patients with complete/partial remission (CR/PR). Here we report the final results of a randomized study comparing R-CVP to R-CHOP both followed by RM. Untreated patients in need of systemic therapy with symptomatic and progressive iNHLs including follicular (FL) and marginal zone lymphoma (MZL), mucosa-associated lymphoid tissue (MALT), small lymphocytic (SLL), and lymphoplasmacytic (LPL) lymphoma were eligible. Patients were randomized to receive R-CVP or R-CHOP for eight cycles or until complete response (CR). All patients with CR/PR (partial response) received RM 375 mg/m 2  q 2 months for 12 cycles. Primary endpoint was event-free survival (EFS). Two-hundred and fifty patients [FL 42%, MZL/MALT 38%, LPL/ Waldenström Macroglobulinaemia (WM) 11%, SLL 9%] were enrolled and randomized (R-CHOP: 127, R-CVP: 123). Median age was 56 years (21-85), 44% were male, 90% were in stage III-IV, 43% of FL patients had a Follicular Lymphoma International Prognostic Index (FLIPI) score ≥3, and 33·4% of all patients had an IPI score ≥3. At the end of induction treatment, the CR/PR rate was 43·6/50·9% and 36·3/60·8% in the R-CHOP and R-CVP groups (P = 0·218) respectively. After a median follow-up of 67, 66, and 70 months, five-year EFS was 61% vs. 56% (not significant), progression-free survival (PFS) was 71% vs. 69% (not significant) and overall survival (OS) was 84% vs. 89% in the R-CHOP vs. the R-CVP arm respectively. Grade III/IV adverse events (65 vs. 22) occurred in 40 (33·1%) and 18 (15·3%) patients, P = 0·001; neutropenia in 16 (11·6%) and 4 (3·4%) patients, P = 0·017; infection in 14 (10·7%) and 3 (2·5%) patients,; P = 0·011; and a second neoplasm in three versus seven patients., in the R-CHOP and the R-CVP groups respectively. This multicentre randomized study with >five-year follow-up shows similar outcome in patients with indolent lymphoma in need of systemic therapy treated with R-CVP or R-CHOP immunochemotherapy and rituximab maintenance in both arms. The minor toxicity of the R-CVP regimen makes it a reasonable choice for induction treatment, leaving other active agents like doxorubicin or bendamustin for second-line therapy.",2020,Rituximab maintenance (RM) significantly improves progression-free survival (PFS) in patients with complete/partial remission (CR/PR).,"['patients with indolent lymphoma in need of systemic therapy treated with', 'patients with complete/partial remission (CR/PR', 'indolent lymphoma with rituximab maintenance', '0·017', 'Untreated patients in need of systemic therapy with symptomatic and progressive iNHLs including follicular (FL) and marginal zone lymphoma (MZL), mucosa-associated lymphoid tissue (MALT), small lymphocytic (SLL), and lymphoplasmacytic (LPL) lymphoma were eligible', 'Two-hundred and fifty patients [FL 42%, MZL/MALT 38%, LPL/ Waldenström Macroglobulinaemia']","['RM', 'R-CVP or R-CHOP immunochemotherapy and rituximab maintenance', 'R-CVP or R-CHOP', 'R-CVP to R-CHOP both followed by RM', 'First-line R-CVP versus R-CHOP induction immunochemotherapy', 'R-CVP (cyclophosphamide, vincristine, prednisone) and R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone + rituximab', 'Rituximab maintenance (RM']","['CR/PR rate', 'event-free survival (EFS', 'progression-free survival (PFS', 'infection', 'overall survival (OS', 'Follicular Lymphoma International Prognostic Index (FLIPI) score ≥3', 'Grade III/IV adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C1367654', 'cui_str': 'Marginal zone lymphoma'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0024296', 'cui_str': 'Lymphatic Tissue'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C2939172', 'cui_str': 'Lymphocytic (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024651', 'cui_str': 'Malt'}, {'cui': 'C0024419', 'cui_str': 'Primary Macroglobulinemia'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4040298', 'cui_str': 'Follicular Lymphoma International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",250.0,0.100444,Rituximab maintenance (RM) significantly improves progression-free survival (PFS) in patients with complete/partial remission (CR/PR).,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Paszkiewicz-Kozik', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Michalski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Rymkiewicz', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szpila', 'Affiliation': 'Institute of Hematology and Transfusiology, Warsaw, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Butrym', 'Affiliation': 'Medical University Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Giza', 'Affiliation': 'Jagiellonian University Collegium Medicum, Krakow, Poland.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Zaucha', 'Affiliation': 'Medical University Gdansk, Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kalinka-Warzocha', 'Affiliation': ""Polish Mother's Memorial Hospital - Research Institute, Lodz, Poland.""}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Wieczorkiewicz', 'Affiliation': 'Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Dagmara', 'Initials': 'D', 'LastName': 'Zimowska-Curyło', 'Affiliation': 'Medical University Wroclaw, Wroclaw, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Knopińska-Posłuszny', 'Affiliation': 'Maritime Hospital, Gdynia, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Tyczyńska', 'Affiliation': 'Maritime Hospital, Gdynia, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Romejko-Jarosińska', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dąbrowska-Iwanicka', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Gruszecka', 'Affiliation': 'Lower Silesia Cell Transplantation Center, Wroclaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jamrozek-Jedlińska', 'Affiliation': 'Municipal Hospital, Poznan, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borawska', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Hołda', 'Affiliation': 'Subcarpathian Voivodeship Hospital, Krosno, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Porowska', 'Affiliation': 'Central Clinical Hospital of the MSWiA, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Romanowicz', 'Affiliation': 'Central Clinical Hospital of the MSWiA, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Hellmann', 'Affiliation': 'Medical University Gdansk, Gdansk, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Stella-Hołowiecka', 'Affiliation': 'Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Deptała', 'Affiliation': 'Central Clinical Hospital of the MSWiA, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center in Warsaw, Warsaw, Poland.'}]",British journal of haematology,['10.1111/bjh.16264']
211,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


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


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


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


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


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
212,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN


Randomized trial.
OBJECTIVES


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


Inpatient rehabilitation.
METHODS


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


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


Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
213,31000783,Role of adipose tissue GLP-1R expression in metabolic improvement after bariatric surgery in patients with type 2 diabetes.,"We aimed to explore the relationship between GLP-1 receptor (GLP-1R) expression in adipose tissue (AT) and incretin secretion, glucose homeostasis and weight loss, in patients with morbid obesity and type 2 diabetes undergoing bariatric surgery. RNA was extracted from subcutaneous (SAT) and visceral (VAT) AT biopsies from 40 patients randomized to metabolic gastric bypass, sleeve gastrectomy or greater curvature plication. Biochemical parameters, fasting plasma insulin, glucagon and area under the curve (AUC) of GLP-1 following a standard meal test were determined before and 1 year after bariatric surgery. GLP-1R expression was higher in VAT than in SAT. GLP-1R expression in VAT correlated with weight (r = -0.453, p = 0.008), waist circumference (r = -0.494, p = 0.004), plasma insulin (r = -0.466, p = 0.007), and systolic blood pressure (BP) (r = -0.410, p = 0.018). At 1 year, GLP-1R expression in VAT was negatively associated with diastolic BP (r = -0.361, p = 0.039) and, following metabolic gastric bypass, with the increase of GLP-1 AUC, (R 2  = 0.46, p = 0.038). Finally, GLP-1R in AT was similar independently of diabetes outcomes and was not associated with weight loss after surgery. Thus, GLP-1R expression in AT is of limited value to predict incretin response and does not play a role in metabolic outcomes after bariatric surgery.",2019,"GLP-1R expression in VAT correlated with weight (r = -0.453, p = 0.008), waist circumference (r = -0.494, p = 0.004), plasma insulin (r = -0.466, p = 0.007), and systolic blood pressure (BP) (r ","['patients with morbid obesity and type 2 diabetes undergoing bariatric surgery', 'patients with type 2 diabetes']","['metabolic gastric bypass, sleeve gastrectomy or greater curvature plication', 'adipose tissue GLP-1R expression']","['visceral (VAT', 'waist circumference', 'weight loss', 'Biochemical parameters, fasting plasma insulin, glucagon and area under the curve (AUC) of GLP-1', 'diastolic BP (r', 'GLP-1R expression in VAT', 'systolic blood pressure (BP', 'GLP-1 AUC', 'GLP-1R expression', 'plasma insulin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",40.0,0.0225138,"GLP-1R expression in VAT correlated with weight (r = -0.453, p = 0.008), waist circumference (r = -0.494, p = 0.004), plasma insulin (r = -0.466, p = 0.007), and systolic blood pressure (BP) (r ","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ejarque', 'Affiliation': ""Hospital Universitari de Tarragona Joan XXIII, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Guerrero-Pérez', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'de la Morena', 'Affiliation': ""Hospital Universitari de Tarragona Joan XXIII, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Casajoana', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Virgili', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López-Urdiales', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Maymó-Masip', 'Affiliation': ""Hospital Universitari de Tarragona Joan XXIII, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Pujol Gebelli', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'Garcia Ruiz de Gordejuela', 'Affiliation': ""Bariatric Surgery Unit, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Maraver', 'Affiliation': ""Department of Endocrinology and Nutrition, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellitero', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': ""Hospital Universitari de Tarragona Joan XXIII, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': ""Hospital Universitari de Tarragona Joan XXIII, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain. jvo@comt.es.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain. nuriavilarrasa@yahoo.es.'}]",Scientific reports,['10.1038/s41598-019-42770-1']
214,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


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


An outpatient clinic, Iran.
METHODS


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


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


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


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


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
215,31535314,Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis.,"Traditional statistical models allow population based inferences and comparisons. Machine learning (ML) explores datasets to develop algorithms that do not assume linear relationships between variables and outcomes and that may account for higher order interactions to make individualized outcome predictions. To evaluate the performance of machine learning models compared to traditional risk stratification methods for the prediction of major adverse cardiovascular events (MACE) and bleeding in patients with acute coronary syndrome (ACS) that are treated with antithrombotic therapy. Data on 24,178 ACS patients were pooled from four randomized controlled trials. The super learner ensemble algorithm selected weights for 23 machine learning models and was compared to traditional models. The efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. The safety endpoint was a composite of TIMI major and minor bleeding or bleeding requiring medical attention. For the MACE outcome, the super learner model produced a higher c-statistic (0.734) than logistic regression (0.714), the TIMI risk score (0.489), and a new cardiovascular risk score developed in the dataset (0.644). For the bleeding outcome, the super learner demonstrated a similar c-statistic as the logistic regression model (0.670 vs. 0.671). The machine learning risk estimates were highly calibrated with observed efficacy and bleeding outcomes (Hosmer-Lemeshow p value = 0.692 and 0.970, respectively). The super learner algorithm was highly calibrated on both efficacy and safety outcomes and produced the highest c-statistic for prediction of MACE compared to traditional risk stratification methods. This analysis demonstrates a contemporary application of machine learning to guide patient-level antithrombotic therapy treatment decisions.Clinical Trial Registration ATLAS ACS-2 TIMI 46: https://clinicaltrials.gov/ct2/show/NCT00402597. Unique Identifier: NCT00402597. ATLAS ACS-2 TIMI 51: https://clinicaltrials.gov/ct2/show/NCT00809965. Unique Identifier: NCT00809965. GEMINI ACS-1: https://clinicaltrials.gov/ct2/show/NCT02293395. Unique Identifier: NCT02293395. PIONEER-AF PCI: https://clinicaltrials.gov/ct2/show/NCT01830543. Unique Identifier: NCT01830543.",2020,"For the bleeding outcome, the super learner demonstrated a similar c-statistic as the logistic regression model (0.670 vs. 0.671).","['24,178 ACS patients', 'acute coronary syndrome', 'patients with acute coronary syndrome (ACS']","['machine learning models', 'machine learning', 'antithrombotic therapy', 'ACS-1', 'Machine learning versus traditional risk stratification methods', 'GEMINI', 'Machine learning (ML']","['composite of TIMI major and minor bleeding or bleeding requiring medical attention', 'TIMI risk score', 'composite of cardiovascular death, myocardial infarction, or stroke', 'efficacy and bleeding outcomes', 'efficacy and safety outcomes', 'new cardiovascular risk score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0608826,"For the bleeding outcome, the super learner demonstrated a similar c-statistic as the logistic regression model (0.670 vs. 0.671).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gibson', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nafee', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Travis', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Yee', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ohman', 'Affiliation': 'The Duke Clinical Research Institute, Duke University, Durham, USA.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'The Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA, USA. mgibson@bidmc.harvard.edu.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-01940-8']
216,31211964,Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function.,"BACKGROUND


Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function.
OBJECTIVE


The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms.
METHODS


This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation (n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ≥12.
RESULTS


At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey score ≥12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P = .8).
CONCLUSION


There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.",2019,There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months.,"['women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation', 'women with refractory UUI treated with onabotulinumtoxinA (n=190) or sacral neuromodulation (n=174', 'Women with refractory urgency urinary incontinence', 'refractory urgency urinary incontinence']","['Sacral Neuromodulation versus OnabotulinumtoxinA', 'onabotulinumtoxinA or sacral neuromodulation', 'BTX and SNM']","['fecal incontinence and sexual symptoms', 'Sexual symptoms', 'fecal incontinence symptoms', 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR', 'Fecal incontinence symptoms', 'mild fecal incontinence symptoms', 'proportion of sexually active women', 'change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12 and PISQ-IR scores', 'Fecal Incontinence and sexual symptoms', 'mean Vaizey scores', 'mean PISQ-12 score', 'fecal incontinence symptom score (Vaizey', ""St Mark's (Vaizey) Fecal Incontinence severity scale"", 'PISQ-IR subscores', 'sexual symptom subscores', 'change in Vaizey and PISQ-12 scores', 'sexual symptoms score', 'fecal incontinence symptoms and sexual function', 'fecal incontinence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.194101,There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months.,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Honeycutt', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': 'Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology Kaiser Permanente, San Diego, California.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradley', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Department of Urology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.06.018']
217,31529007,Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.,"Importance


Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.
Objective


To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.
Design, Setting, and Participants


Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.
Interventions


Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).
Main Outcomes and Measures


The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.
Results


Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).
Conclusions and Relevance


Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.
Trial Registration


ClinicalTrials.gov Identifier: NCT01959347.",2019,"The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2).","['480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses', 'Women With Mixed Urinary Incontinence', 'women with mixed urinary incontinence', 'women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary', '9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017']","['Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone', 'midurethral sling surgery', 'behavioral and pelvic floor muscle therapy with midurethral sling', 'Interventions\n\n\nBehavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n\u2009=\u2009209) vs sling alone']","['Incontinence Symptoms', 'UDI score', 'Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference', 'mixed incontinence symptoms', 'urinary incontinence symptoms', 'serious adverse events']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0869256', 'cui_str': 'Mixed incontinence (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0869256', 'cui_str': 'Mixed incontinence (finding)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",480.0,0.173567,"The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2).","[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Borello-France', 'Affiliation': 'Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': 'The Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Diego, La Jolla.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ""Women's Center for Bladder and Pelvic Health, Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'The Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia.'}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': 'The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque.'}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ""Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.""}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': 'The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.12467']
218,31712614,Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.,"STUDY DESIGN


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


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


Three Dutch SCI rehabilitation centres.
METHODS


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


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


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


The Dutch Trial Register- NTR 5831.",2020,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","['persons with spinal cord injury', 'Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0', 'Three Dutch SCI rehabilitation centres', 'people with\xa0spinal cord injury (SCI']","['placebo', 'multispecies probiotic', 'probiotics/placebo']","['degree of nausea and information on quality of life', 'incidence of antibiotic-associated diarrhoea', 'Bristol Stool Scale, and bowel management', 'time to reach effective bowel management, degree of nausea and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0222045'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",56.0,0.712196,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","[{'ForeName': 'W X M', 'Initials': 'WXM', 'LastName': 'Faber', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nachtegaal', 'Affiliation': 'Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stolwijk-Swuste', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Achterberg-Warmer', 'Affiliation': 'Amsterdam Rehabilitation Research Center, Reade, the Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'Koning', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'van Bennekom', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}]",Spinal cord,['10.1038/s41393-019-0369-y']
219,32065672,Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.,"OBJECTIVE


The study assesses the bioavailability of diazepam after intranasal administration (diazepam nasal spray) in healthy volunteers. Comparative agents were diazepam rectal gel, which served as the regulatory reference product; and oral diazepam, a product with decades of clinical use. Tolerability of diazepam nasal spray was also assessed.
METHODS


This was a phase 1, open-label, randomized, single-dose, three-treatment, three-period, six-sequence crossover study in 48 healthy adult subjects that consisted of a screening period, a baseline period, and an open-label treatment period. Interperiod intervals were at least 28 days.
RESULTS


Forty-eight healthy volunteer subjects were enrolled, two of whom discontinued before receiving study medication. For all routes of administration, the onset of diazepam absorption was rapid, with measurable concentrations of drug present by the first sample time point. The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals. Variability (as defined by % coefficient of variation of geometric mean) in peak plasma concentration and area under the curve 0-∞  was lowest with oral diazepam, followed by diazepam nasal spray, with diazepam rectal gel showing the greatest variability. Overall, 131 treatment-emergent adverse events (TEAEs) were considered mild (42 subjects, 91.3%), four TEAEs were considered moderate (four subjects, 8.3%), and no TEAEs were considered severe. The most commonly reported TEAE was somnolence at 56.5% (26/46) during diazepam nasal spray treatment, 89.1% (41/46) with the rectal diazepam gel treatment, and 82.6% (38/46) with oral diazepam treatment. No nasal irritation was observed for the majority of the subjects at any time point after administration, with no score higher than 2 (""minor bleeding that stops within 1 minute"").
SIGNIFICANCE


Diazepam nasal spray shows predicable pharmacokinetics and represents a potential novel therapeutic approach to control bouts of increased seizure activity (cluster seizures, acute repetitive seizures).",2020,"The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals.","['healthy volunteers', '48 healthy adult subjects', 'Forty-eight healthy volunteer subjects']","['intranasal administration (diazepam nasal spray', 'diazepam rectal gel', 'oral and rectal diazepam', 'diazepam nasal spray, with diazepam rectal gel', 'diazepam nasal spray', 'diazepam intranasal solution', 'diazepam']","['somnolence', 'Bioavailability and safety', 'Tolerability', 'bioavailability', 'peak plasma concentration and area under the curve', 't max  (time to reach maximum plasma concentration', 'nasal irritation', 'Variability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0001560', 'cui_str': 'Drug Administration, Intranasal'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C2340854', 'cui_str': 'Diazepam Rectal Gel [Diastat]'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0240557', 'cui_str': 'Irritation of nose'}]",48.0,0.0266964,"The t max  (time to reach maximum plasma concentration) was similar for diazepam nasal spray and diazepam rectal gel, both of which were slower than oral diazepam in fasted individuals.","[{'ForeName': 'R Edward', 'Initials': 'RE', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Washington University in St Louis School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Barry E', 'Initials': 'BE', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York.'}, {'ForeName': 'Luana P', 'Initials': 'LP', 'LastName': 'Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Lowenthal', 'Affiliation': 'Pacific Link Consulting, San Diego, California.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Carrazana', 'Affiliation': 'Consultant for Neurelis, Miami, Florida.'}]",Epilepsia,['10.1111/epi.16449']
220,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961']
221,32259228,Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial.,"Importance


Patients with advanced soft tissue sarcoma (STS) have a median overall survival of less than 2 years. In a phase 2 study, an overall survival benefit in this population was observed with the addition of olaratumab to doxorubicin over doxorubicin alone.
Objective


To determine the efficacy of doxorubicin plus olaratumab in patients with advanced/metastatic STS.
Design, Setting, and Participants


ANNOUNCE was a confirmatory, phase 3, double-blind, randomized trial conducted at 110 sites in 25 countries from September 2015 to December 2018; the final date of follow-up was December 5, 2018. Eligible patients were anthracycline-naive adults with unresectable locally advanced or metastatic STS, an Eastern Cooperative Oncology Group performance status of 0 to 1, and cardiac ejection fraction of 50% or greater.
Interventions


Patients were randomized 1:1 to receive doxorubicin, 75 mg/m2 (day 1), combined with olaratumab (n = 258), 20 mg/kg in cycle 1 and 15 mg/kg in subsequent cycles, or placebo (n = 251) on days 1 and 8 for up to 8 21-day cycles, followed by olaratumab/placebo monotherapy.
Main Outcomes and Measures


Dual primary end points were overall survival with doxorubicin plus olaratumab vs doxorubicin plus placebo in total STS and leiomyosarcoma (LMS) populations.
Results


Among the 509 patients randomized (mean age, 56.9 years; 58.2% women; 46.0% with LMS), all were included in the primary analysis and had a median length of follow-up of 31 months. No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95 [95% CI, 0.69-1.31], P = .76, median overall survival, 21.6 months vs 21.9 months). Adverse events of grade 3 or greater reported in 15% or more of total patients with STS were neutropenia (46.3% vs 49.0%), leukopenia (23.3% vs 23.7%), and febrile neutropenia (17.5% vs 16.5%).
Conclusions and Relevance


In this phase 3 clinical trial of patients with advanced STS, treatment with doxorubicin plus olaratumab vs doxorubicin plus placebo resulted in no significant difference in overall survival. The findings did not confirm the overall survival benefit observed in the phase 2 trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02451943.",2020,"No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95","['Eligible patients were anthracycline-naive adults with unresectable locally advanced or metastatic STS, an Eastern Cooperative Oncology Group performance status of 0 to 1, and cardiac ejection fraction of 50% or greater', 'patients with advanced/metastatic STS', 'Patients with advanced soft tissue sarcoma (STS', '509 patients randomized (mean age, 56.9 years; 58.2% women; 46.0% with LMS), all were included in the primary analysis and had a median length of follow-up of 31 months', 'patients with advanced STS, treatment with', 'Patients With Advanced Soft Tissue Sarcomas', '110 sites in 25 countries from September 2015 to December 2018; the final date of follow-up was December 5, 2018']","['Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo', 'olaratumab/placebo monotherapy', 'doxorubicin plus olaratumab', 'doxorubicin plus olaratumab vs doxorubicin plus placebo', 'doxorubicin', 'doxorubicin plus placebo', 'combined with olaratumab (n\u2009=\u2009258), 20 mg/kg in cycle 1 and 15 mg/kg in subsequent cycles, or placebo']","['overall survival benefit', 'Survival', 'leukopenia', 'febrile neutropenia', 'median overall survival', 'overall survival', 'neutropenia', 'total STS and leiomyosarcoma (LMS) populations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0232174', 'cui_str': 'Cardiac ejection fraction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2698152', 'cui_str': 'olaratumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",509.0,0.716157,"No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population (total STS: hazard ratio, 1.05 [95% CI, 0.84-1.30], P = .69, median overall survival, 20.4 months vs 19.7 months; LMS: hazard ratio, 0.95","[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wagner', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin-Broto', 'Affiliation': 'Medical Oncology Department in University Hospital Virgen del Rocio and Institute of Biomedicine of Sevilla (IBIS) (HUVR, CSIC, University of Sevilla), Sevilla, Spain.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Krarup-Hansen', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Chueh-Chuan', 'Initials': 'CC', 'LastName': 'Yen', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Cancer Specialists, Fairfax.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kawai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Department of Internal Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fedenko', 'Affiliation': 'Blokhin Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Pápai', 'Affiliation': 'Magyar Honvedseg Eu Kp, Budapest, Hungary.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Soldatenkova', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Shahir', 'Affiliation': 'Eli Lilly and Company, Windlesham, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Mo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1707']
222,32204120,"The effects of eccentric strengthening exercises on foot alignment change, malleolus height and agility level of junior badminton players in Makassar.","OBJECTIVE


This study aims to determine the effect of the eccentric strengthening exercises on changes in foot alignment, height, and agility level malleolus of junior athletes.
METHOD


This study used a pre-experimental time-series design. A total of 30 junior badminton athletes were recruited to participate. The age ranged from 11 to 15 years old. Data collection is done through the primary retrieval of data through the measurement instrument of foot alignment, malleolus height, and agility.
RESULTS


From the results of the SPSS Obtained a significant value of p=0.0001 (p<0.05) after 18 times the exercise was given.
CONCLUSION


There is an influence of eccentric strengthening exercise on changes in foot alignment, height, and agility malleolus in junior-level badminton players in Makassar. malleolus height and agility.",2020,"From the results of the SPSS Obtained a significant value of p=0.0001 (p<0.05) after 18 times the exercise was given.
","['junior-level badminton players in Makassar', 'junior badminton players in Makassar', '30 junior badminton athletes', 'junior athletes']","['eccentric strengthening exercise', 'eccentric strengthening exercises']","['foot alignment change, malleolus height and agility level', 'foot alignment, height, and agility level malleolus', 'malleolus height and agility']","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.0307755,"From the results of the SPSS Obtained a significant value of p=0.0001 (p<0.05) after 18 times the exercise was given.
","[{'ForeName': '', 'Initials': '', 'LastName': 'Hermilasari', 'Affiliation': 'Physiotherapy Study Program, Faculty of Nursing, Hasanuddin University, Makassar, Indonesia. Electronic address: sari.hermila@yahoo.co.id.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Irianto', 'Affiliation': 'Physiotherapy Study Program, Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Adi Ahmad', 'Initials': 'AA', 'LastName': 'Gondo', 'Affiliation': 'Physiotherapy Study Program, Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.045']
223,32293033,PRIME-HF: Novel Exercise for Older Patients with Heart Failure. A Pilot Randomized Controlled Study.,"OBJECTIVES


To test the hypothesis that (1) older patients with heart failure (HF) can tolerate COMBined moderate-intensity aerobic and resistance training (COMBO), and (2) 4 weeks of Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) before 4 weeks of COMBO will improve aerobic capacity and muscle strength to a greater extent than 8 weeks of COMBO.
DESIGN


Prospective randomized parallel open-label blinded end point.
SETTING


Single-site Australian metropolitan hospital.
PARTICIPANTS


Nineteen adults (72.8 ± 8.4 years of age) with heart failure with reduced ejection fraction (HFrEF).
INTERVENTION


Participants were randomized to 4 weeks of PRIME or COMBO (phase 1). All participants subsequently completed 4 weeks of COMBO (phase 2). Sessions were twice a week for 60 minutes. PRIME is a low-mass, high-repetition regime (40% one-repetition maximum [1RM], eight strength exercises, 5 minutes each). COMBO training involved combined aerobic (40%-60% of peak aerobic capacity [VO 2peak  ], up to 20 minutes) and resistance training (50-70% 1RM, eight exercises, two sets of 10 repetitions).
MEASUREMENTS


We measured VO 2peak  , VO 2  at anaerobic threshold (AT), and muscle voluntary contraction (MVC).
RESULTS


The PRIME group significantly increased VO 2peak  after 8 weeks (2.4 mL/kg/min; 95% confidence interval [CI] = .7-4.1; P = .004), whereas the COMBO group showed minimal change (.2; 95% CI -1.5 to 1.8). This produced a large between-group effect size of 1.0. VO 2  at AT increased in the PRIME group (1.6 mL/kg/min; 95% CI .0-3.2) but not in the COMBO group (-1.2; 95% CI -2.9 to .4), producing a large between-group effect size. Total MVC increased significantly in both groups in comparison with baseline; however, the change was larger in the COMBO group (effect size = .6).
CONCLUSION


Traditional exercise approaches (COMBO) and PRIME improved strength. Only PRIME training produced statistically and clinically significant improvements to aerobic capacity. Taken together, these findings support the hypothesis that PRIME may have potential advantages for older patients with HFrEF and could be a possible alternative exercise modality.",2020,"Total MVC increased significantly in both groups in comparison with baseline; however, the change was larger in the COMBO group (effect size = .6).
","['Single-site Australian metropolitan hospital', 'older patients with HFrEF', 'older patients with heart failure (HF', 'Older Patients with Heart Failure', 'Nineteen adults (72.8\u2009±\u20098.4\u2009years of age) with heart failure with reduced ejection fraction (HFrEF']","['PRIME-HF', 'tolerate COMBined moderate-intensity aerobic and resistance training (COMBO), and (2) 4\u2009weeks of Peripheral Remodeling through Intermittent Muscular Exercise (PRIME', 'Traditional exercise approaches (COMBO', 'Novel Exercise', 'COMBO training']","['aerobic capacity', 'VO 2peak  , VO 2  at anaerobic threshold (AT), and muscle voluntary contraction (MVC', 'aerobic capacity and muscle strength', 'VO 2  at AT', 'Total MVC', 'VO 2peak']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",19.0,0.0772327,"Total MVC increased significantly in both groups in comparison with baseline; however, the change was larger in the COMBO group (effect size = .6).
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Giuliano', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Levinger', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vogrin', 'Affiliation': 'Australian Institute for Musculoskeletal Science (AIMSS), Melbourne, Australia.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Neil', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jason David', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Department of Kinesiology, Curry School of Education & Division of Cardiovascular Medicine, University of Virginia, Charlottesville, Virginia, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16428']
224,32204172,Effectiveness of music therapy in reducing the level of anxiety among cancer patients undergoing chemotherapy.,"OBJECTIVE


To evaluate the effectiveness of music therapy on the level of difficulty in cancer patients undergoing chemotherapy.
METHODS


This study was a quasi-experiment with nonprobability sampling technique consisting of 60 participants, divided into intervention groups and control groups of 30 samples for each based on inclusion and exclusion criteria.
RESULTS


The three sessions of music therapy are significantly reducing the anxiety level of cancer patients undergoing chemotherapy (p<0.001) in the intervention group. Meanwhile, no significant reducing of anxiety among the control group (p=0.139).
CONCLUSION


Music therapy is effective in reducing anxiety levels of cancer patients who are undergoing chemotherapy.",2020,The three sessions of music therapy are significantly reducing the anxiety level of cancer patients undergoing chemotherapy (p<0.001) in the intervention group.,"['cancer patients undergoing chemotherapy (p<0.001) in the intervention group', '60 participants, divided into intervention groups and control groups of 30 samples for each based on inclusion and exclusion criteria', 'cancer patients who are undergoing chemotherapy', 'cancer patients undergoing chemotherapy']","['Music therapy', 'music therapy']","['level of anxiety', 'anxiety', 'anxiety level', 'anxiety levels']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0443229,The three sessions of music therapy are significantly reducing the anxiety level of cancer patients undergoing chemotherapy (p<0.001) in the intervention group.,"[{'ForeName': 'Aulia Insani', 'Initials': 'AI', 'LastName': 'Latif', 'Affiliation': 'Graduate Program of Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}, {'ForeName': 'Nurun Salaman', 'Initials': 'NS', 'LastName': 'Alhidayat', 'Affiliation': 'Graduate Program of Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}, {'ForeName': 'Satria Hanggara', 'Initials': 'SH', 'LastName': 'Putra', 'Affiliation': 'Graduate Program of Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}, {'ForeName': 'Kadek Ayu', 'Initials': 'KA', 'LastName': 'Erika', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia. Electronic address: kadek20_uh@yahoo.com.'}, {'ForeName': 'Syahrul', 'Initials': 'S', 'LastName': 'Ningrat', 'Affiliation': 'Department of Medical-Surgical Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}, {'ForeName': 'Syahrul', 'Initials': 'S', 'LastName': 'Syahrul', 'Affiliation': 'Department of Community and Family Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.022']
225,32078692,The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil.,"BACKGROUND


Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.
OBJECTIVE


To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).
METHODS


HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up.
RESULTS


A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
CONCLUSION


Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.
VIDEO ABSTRACT


",2020,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","['600 patients were randomized (HES, n\xa0=\xa0297 and BPC, n\xa0=\xa0303), including 28% with ruptured aneurysms', 'enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling']","['second-generation HES and bare platinum coil (BPC', 'Hydrogel Endovascular Aneurysm Treatment Trial (HEAT', 'Second-Generation Hydrogel Coil']","['Recurrence', 'minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up', 'adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms', 'packing density and both major and minor recurrence rates', 'initial occlusion rate', 'aneurysm recurrence using the Raymond-Roy scale']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162869', 'cui_str': 'Aneurysm, Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial Aneurysm'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0222045'}]",600.0,0.104487,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","[{'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bendok', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Abi-Aad', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Ward', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Kniss', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Rudy J', 'Initials': 'RJ', 'LastName': 'Rahme', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Salah G', 'Initials': 'SG', 'LastName': 'Aoun', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Tarek Y', 'Initials': 'TY', 'LastName': 'El Ahmadieh', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Najib E', 'Initials': 'NE', 'LastName': 'El Tecle', 'Affiliation': 'Department of Neurological Surgery, Saint Louis University Hospital, St. Louis, Missouri.'}, {'ForeName': 'Samer G', 'Initials': 'SG', 'LastName': 'Zammar', 'Affiliation': 'Department of Neurological Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Rami James N', 'Initials': 'RJN', 'LastName': 'Aoun', 'Affiliation': 'Department of General Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Devi P', 'Initials': 'DP', 'LastName': 'Patra', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Ansari', 'Affiliation': 'Department of Radiology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Laboratoire de Neuroradiologie Interventionnelle, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Radiology, Stony Brook University Hospital, Stony Brook, New York.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dabus', 'Affiliation': 'Interventional Neuroradiology and Neuroendovascular Surgery, Miami Cardiac and Vascular Institute, Miami, Florida.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Milot', 'Affiliation': 'Département de Chirurgie, CHU de Quebec, Quebec City, Canada.'}, {'ForeName': 'Josser E', 'Initials': 'JE', 'LastName': 'Delgado Almandoz', 'Affiliation': 'Department of Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'DeNardo', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Shervin R', 'Initials': 'SR', 'LastName': 'Dashti', 'Affiliation': 'Department of Neurological Surgery Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyaa006']
226,32204153,Effect of digital storytelling on self-efficacy of patients with a stoma: Preliminary study.,"OBJECTIVE


The purpose of this study to evaluate the effect of digital storytelling on the self-efficacy of ostomate.
METHOD


Pre-experimental research using the one pretest-posttest group design approach to assess the patient's self-efficacy before and after giving the intervention storytelling for 10-15min with iPad media and headphone; one patient intervened once. Duration of study for one month. The contents of the video are stories from the Ostomates who have been able to survive with the condition of the stoma attached. The patient's pre-test and post-self-efficacy were measured using the general self-efficacy questionnaire.
RESULTS


Based on the results of the paired t-test statistical test or paired-test obtained p-value 0.000 (2-way test), which means that there are statistically significant differences between the average self-efficacy before and after digital storytelling intervention (p-value=0.000).
CONCLUSION


There is a difference in mean ostomate self-efficacy after being given a digital storytelling intervention.",2020,There is a difference in mean ostomate self-efficacy after being given a digital storytelling intervention.,['patients with a stoma'],"['digital storytelling', 'intervention storytelling for 10-15min with iPad media and headphone']","['general self-efficacy questionnaire', 'mean ostomate self-efficacy', 'average self-efficacy', 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0210967,There is a difference in mean ostomate self-efficacy after being given a digital storytelling intervention.,"[{'ForeName': 'Masriani', 'Initials': 'M', 'LastName': 'Zainuddin', 'Affiliation': 'Sinjai General Hospital, Sinjai, Indonesia; Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Kasmawati', 'Initials': 'K', 'LastName': 'Kadir', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia; General Hospital of West Sulawesi Province, Mamuju, Indonesia.'}, {'ForeName': 'Anggia Riske', 'Initials': 'AR', 'LastName': 'Wijayanti', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia; Nusa Nipa University, Maumere, Indonesia.'}, {'ForeName': 'Yuliana', 'Initials': 'Y', 'LastName': 'Syam', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Majid', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia. Electronic address: abdul.majidunhas@gmail.com.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.015']
227,32204155,The effect of listening to the recitation of Qur'an (Murottal Ar-Rahman surah) on the level of anxiety of pregnant women in Siti Fatimah maternal and child hospital.,"OBJECTIVE


This study aimed to investigate the effect of listening to the recitation of Qur'an, specifically Ar-Rahman surah, on the level of anxiety and the time of the first stage of labor in pregnant women.
METHOD


This study was a quasi-experiment using non-randomized pre- and post-test with control design. The study was conducted in Siti Fatimah Maternal and Child Hospital, a public hospital in Makassar City, Indonesia. Total 40 samples were selected purposively, and they were divided into two groups, 20 respondents in the intervention group and 20 respondents in the control group. Chi-square test was performed for data analysis.
RESULTS


This study shows that there were significant changes in the level of anxiety after listening to Ar-Rahman surah (p<0.001). Meanwhile, no changes in the level of anxiety in the control group (p=0.50). The result of this study also showed that the score of anxiety, cortisol level and time of labor were significantly lower in the intervention group than in the control group (p<0.001, p=0.001, and p<0.001, respectively).
CONCLUSION


Listening to the recitation of Qur'an, especially Ar-Rahman surah, could reduce the anxiety burden of pregnant women in facing the labor process. This treatment may also give benefit to the cortisol level and reduced time for labor. A further study with a randomized controlled trial in a large-scale sample can robust the findings of this study.",2020,"Listening to the recitation of Qur'an, especially Ar-Rahman surah, could reduce the anxiety burden of pregnant women in facing the labor process.","['pregnant women in Siti Fatimah maternal and child hospital', 'Siti Fatimah Maternal and Child Hospital, a public hospital in Makassar City, Indonesia', 'pregnant women', 'Total 40 samples were selected purposively, and they were divided into two groups, 20 respondents in the intervention group and 20 respondents in the control group']","[""listening to the recitation of Qur'an (Murottal Ar-Rahman surah""]","['score of anxiety, cortisol level and time of labor', 'level of anxiety', 'cortisol level and reduced time for labor']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0343844', 'cui_str': 'Siti (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",40.0,0.032229,"Listening to the recitation of Qur'an, especially Ar-Rahman surah, could reduce the anxiety burden of pregnant women in facing the labor process.","[{'ForeName': '', 'Initials': '', 'LastName': 'Irmawati', 'Affiliation': 'Midwifery Department, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Nutrition Department, Faculty of Public Health, Hasanuddin University, Indonesia. Electronic address: phunhas@gmail.com.'}, {'ForeName': 'Saidah', 'Initials': 'S', 'LastName': 'Syamsuddin', 'Affiliation': 'Psychiatry Department, Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Imam', 'Initials': 'AI', 'LastName': 'Arundhana', 'Affiliation': 'Nutrition Department, Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.097']
228,32291223,"Adding mobilisation with movement to exercise and advice hastens the improvement in range, pain and function after non-operative cast immobilisation for distal radius fracture: a multicentre, randomised trial.","QUESTION


Does adding mobilisation with movement (MWM) to usual care (ie, exercises plus advice) improve outcomes after immobilisation for a distal radius fracture?
DESIGN


A prospective, multicentre, randomised, clinical trial with concealed allocation, blinding and intention-to-treat analysis.
PARTICIPANTS


Sixty-seven adults (76% female, mean age 60 years) treated with casting after distal radius fracture.
INTERVENTION


The control group received exercises and advice. The experimental group received the same exercises and advice, plus supination and wrist extension MWM.
OUTCOME MEASURES


The primary outcome was forearm supination at 4 weeks (immediately post-intervention). Secondary outcomes included wrist extension, flexion, pronation, grip strength, QuickDASH (Disabilities of Arm, Shoulder and Hand), Patient-Rated Wrist Evaluation (PRWE) and global rating of change. Follow-up time points were 4 and 12 weeks, with patient-rated measures at 26 and 52 weeks.
RESULTS


Compared with the control group, supination was greater in the experimental group by 12 deg (95% CI 5 to 20) at 4 weeks and 8 deg (95% CI 1 to 15) at 12 weeks. Various secondary outcomes were better in the experimental group at 4 weeks: extension (14 deg, 95% CI 7 to 20), flexion (9 deg, 95% CI 4 to 15), QuickDASH (-11, 95% CI -18 to -3) and PRWE (-13, 95% CI -23 to -4). Benefits were still evident at 12 weeks for supination, extension, flexion and QuickDASH. The experimental group were more likely to rate their global change as 'improved' (risk difference 22%, 95% CI 5 to 39). There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects.
CONCLUSION


Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture.
REGISTRATION


ACTRN12615001330538.",2020,"There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects.
CONCLUSION


Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture.
","['Sixty-seven adults (76% female, mean age 60 years) treated with casting after distal radius fracture', 'distal radius fracture']","['exercises and advice', 'same exercises and advice, plus supination and wrist extension MWM', 'mobilisation with movement (MWM) to usual care (ie, exercises plus advice']","[""rate their global change as 'improved"", 'flexion', 'motion impairments', 'forearm supination', 'wrist extension, flexion, pronation, grip strength, QuickDASH (Disabilities of Arm, Shoulder and Hand), Patient-Rated Wrist Evaluation (PRWE) and global rating of change', 'QuickDASH', 'range, pain and function']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",67.0,0.284206,"There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects.
CONCLUSION


Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture.
","[{'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Reid', 'Affiliation': 'School of Allied Health, Australian Catholic University, Sydney, Australia. Electronic address: Sue.Reid@acu.edu.au.'}, {'ForeName': 'Josef M', 'Initials': 'JM', 'LastName': 'Andersen', 'Affiliation': 'MULLIGAN DK, Hørsholm, Denmark.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.03.010']
229,32286911,Effectiveness of Different Laser-Assisted In-Office Bleaching Techniques: 1-Year Follow-Up.,"Objective:  The aim of this study was to evaluate color longevity after different bleaching techniques.  Background:  Laser-activated bleaching methods are gaining popularity due to decreased chair time and increased patient compliance. However, the longevity of such methods has not been stated clearly.  Methods:  Sixty patients were divided into the following three groups ( n  = 20); group 1: chemical bleaching with 35% hydrogen peroxide (HP) gel, group 2: bleaching with 35% HP gel with diode laser activation, and group 3: bleaching with 35% HP gel with Er,Cr:YSGG laser activation. Color changes (ΔE*) were calculated by using two different formulas: (i) CIELAB (ΔE ab ) and (ii) CIEDE2000 (ΔE 00 ) with a spectrophotometer before treatment, 24 h after treatment 3, 6, and 12 months after treatment. Evaluation of postoperative sensitivity was performed before and immediately after treatment, followed by re-evaluation 24 h and 1 week after treatment.  Results:  For ΔE ab  calculation, no significant difference was observed during both intra- and inter-group evaluations ( p  > 0.05). For ΔE 00  calculation, no significant intergroup difference was observed ( p  > 0.05), whereas significant intragroup differences between the values of after treatment, 6-12 months. In the chemical bleaching group, increased postoperative sensitivity was observed after 24 h ( p  < 0.001). In the diode-laser-activated group, postoperative hypersensitivity was detected at 24 h and 1 week. No significant hypersensitivity was observed in the Er,Cr:YSGG-laser-activated group ( p  > 0.05).  Conclusions:  All three techniques provided efficient bleaching. Chemical and diode-activated bleaching methods resulted in slight sensitivity after application, whereas Er,Cr:YSGG-laser-activated bleaching did not cause sensitivity.",2020,No significant hypersensitivity was observed in the Er,['Sixty patients'],"['Laser-activated bleaching methods', 'chemical bleaching with 35% hydrogen peroxide (HP) gel, group 2: bleaching with 35% HP gel with diode laser activation, and group 3: bleaching with 35% HP gel with Er,Cr:YSGG laser activation', 'Different Laser-Assisted In-Office Bleaching Techniques']","['hypersensitivity', 'color longevity', 'postoperative sensitivity', 'postoperative hypersensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",60.0,0.0206102,No significant hypersensitivity was observed in the Er,"[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Surmelioglu', 'Affiliation': 'Department of Restorative Dentistry, Dentistry Faculty, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Usumez', 'Affiliation': 'Department of Prosthodontics, Private Clinic, Dental Plus Istanbul, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4741']
230,32204145,The effect back massage to the height of uterine fundus in primiparous normal postpartum mothers.,"OBJECTIVE


The study aimed to determine whether there is an effect of back massage on the decrease in the height of uterine fundus in primiparous normal postpartum mothers.
METHODS


The subjects of 80 primiparous postpartum respondents using accidental sampling technique. Respondents were divided into two groups: the experimental group and the control group. The intervention was carried out, i.e., back massage two times a day for 15min. Height of uterine fundus was evaluated on day 1,4,7 using an observation sheet.
RESULTS


Mann-Whitney U statistical test obtained a p-value<0.05, there is the effect significant of back massage to decrease the height of uterine fundus.
CONCLUSION


Our result confirmed that in Back massage can help increase the amount of the hormone oxytocin, which will have an impact on accelerating the decrease in the height of uterine fundus.",2020,"RESULTS


Mann-Whitney U statistical test obtained a p-value<0.05, there is the effect significant of back massage to decrease the height of uterine fundus.
","['80 primiparous postpartum respondents using accidental sampling technique', 'primiparous normal postpartum mothers']",['back massage'],"['Height of uterine fundus', 'height of uterine fundus']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0426012', 'cui_str': 'Height of uterine fundus (observable entity)'}]",80.0,0.0194025,"RESULTS


Mann-Whitney U statistical test obtained a p-value<0.05, there is the effect significant of back massage to decrease the height of uterine fundus.
","[{'ForeName': 'Tenri', 'Initials': 'T', 'LastName': 'Ajeng', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, Indonesia. Electronic address: mardianaahmad@pasca.unhas.ac.id.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.078']
231,32204157,Polymorphism nucleotide oligomerization domain-2 (NOD2) in neonatal with early breastfeeding initiation.,"OBJECTIVE


This study aimed to determine if NOD2 gene polymorphisms are found in neonatal with early breastfeeding initiation and neonatal without early breastfeeding initiation.
METHOD


This study used a Quasy Experiment type, with Non-equivalent Control Group Design. The sample in this study were 60 pregnant women; gestational age±34 and 36 weeks, normal delivery, and carried out early breastfeeding at the Siti Fatima maternal and child hospital and Public Health Center Bara-baraya. The sample was divided into two groups, i.e., the intervention group as many as 30 neonatal and the control group as many as 30 neonatal. Samples were taken from blood from the umbilical cord as much as three cc for the examination of NOD2 polymorphisms.
RESULTS


The group that was given early breastfeeding initiation intervention had a polymorphism frequency of 1 person (3.33%), while the control group had a polymorphism frequency of 4 people (6.67%).
CONCLUSION


The control group, i.e., infants who did not get early breastfeeding initiation had a higher frequency of NOD2 gene mutations compared to the group that received early breastfeeding initiation.",2020,"The group that was given early breastfeeding initiation intervention had a polymorphism frequency of 1 person (3.33%), while the control group had a polymorphism frequency of 4 people (6.67%).
","['60 pregnant women; gestational age±34 and 36 weeks, normal delivery, and carried out early breastfeeding at the Siti Fatima maternal and child hospital and Public Health Center Bara-baraya']",['Polymorphism nucleotide oligomerization domain-2 (NOD2'],['frequency of NOD2 gene mutations'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure (procedure)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0343844', 'cui_str': 'Siti (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0596611'}]",60.0,0.0267237,"The group that was given early breastfeeding initiation intervention had a polymorphism frequency of 1 person (3.33%), while the control group had a polymorphism frequency of 4 people (6.67%).
","[{'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Midwifery Department, Graduated School, Hasanuddin University, Indonesia. Electronic address: mardianaahmad@pasca.unhas.ac.id.'}, {'ForeName': 'A Arsunan', 'Initials': 'AA', 'LastName': 'Arsin', 'Affiliation': 'Epidemiology Department, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Saifuddin', 'Initials': 'S', 'LastName': 'Sirajuddin', 'Affiliation': 'Nutrition Department, Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Muh', 'Initials': 'M', 'LastName': 'Syafar', 'Affiliation': 'Health Promotion Department, Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.016']
232,32272973,The effect of vitamin D supplementation on serum total 25(OH) levels and biochemical markers of skeletal muscles in runners.,"BACKGROUND


The beneficial adaptation of skeletal muscle function to strenuous exercise is partially attributable to the improvement of vitamin D status. The present study aimed to evaluate the effects of a 3-week vitamin D supplementation on serum 25(OH)D levels and skeletal muscle biomarkers (i.e. troponin, myoglobin, creatine kinase and lactic dehydrogenase) of endurance runners.
METHODS


A double-blind placebo-controlled study design was used and vitamin D supplementation was compared to a non-treatment control group. Twenty-four runners, competitors of the ultra-marathons held during the National Running Championships, were randomly assigned into two groups supplemented with the dose of 2000 IU vitamin D or placebo for three weeks. All subjects participated in three exercise protocols: (a) incremental exercise test (to determine the maximum oxygen uptake and the intensity of eccentric exercise), (b) eccentric exercise before and (c) after two dietary protocols. Venous blood samples were drawn at rest, immediately after the exercise and after 1 h and 24 h of recovery in order to estimate serum 25(OH)D levels, skeletal muscle biomarkers, proinflammatory cytokines and tumor necrosis factor-alpha (TNF-α) levels. A two-way ANOVA was used to test main effects and their interactions and Pearson correlation coefficients were analyzed to determine the effects of inter-variable relationships.
RESULTS


Significant differences between pre- and post-intervention in baseline 25(OH)D levels were observed (34.9 ± 4.7 versus 40.3 ± 4.9 ng/ml, p = 0.02) in supplemented group. A higher post intervention 25(OH)D level was observed after vitamin D diet compared to placebo (40.3 ± 4.9 versus 31.8 ± 4.2 ng/mL, respectively; p < 0.05). The vitamin D supplementation decreased post-exercise (TN max) and 1 h post-exercise troponin (p = 0.004, p = 0.03, respectively), 1 h post-exercise myoglobin concentration (p = 0.01) and TNF-α levels(p < 0.03). 24 h post exercise creatine kinase activity was significantly lower in supplemented group compared to placebo (p < 0.05). A negative correlation was observed between post exercise 25(OH)D levels and myoglobin levels (r = - 0.57; p = 0.05), and 25(OH)D levels and TNFα (r = - 0.58; p = 0.05) in vitamin D supplemented group.
CONCLUSIONS


Three weeks of vitamin D supplementation had a positive effect on serum 25(OH)D levels in endurance trained runners and it caused a marked decrease in post-exercise biomarkers levels. We concluded that vitamin D supplementation might play an important role in prevention of skeletal muscle injuries following exercise with eccentric muscle contraction in athletes.",2020,24 h post exercise creatine kinase activity was significantly lower in supplemented group compared to placebo (p < 0.05).,"['athletes', 'Twenty-four runners, competitors of the ultra-marathons held during the National Running Championships', 'endurance runners', 'endurance trained runners', 'All subjects participated in three exercise protocols: (a', 'runners']","['vitamin D supplementation', 'vitamin D or placebo', 'incremental exercise test (to determine the maximum oxygen uptake and the intensity of eccentric exercise), (b) eccentric exercise', 'placebo']","['serum 25(OH)D levels', 'Venous blood samples', 'post-exercise biomarkers levels', '25(OH)D levels and TNFα', 'serum total 25(OH) levels and biochemical markers of skeletal muscles', 'post exercise 25(OH)D levels and myoglobin levels', 'baseline 25(OH)D levels', 'serum 25(OH)D levels, skeletal muscle biomarkers, proinflammatory cytokines and tumor necrosis factor-alpha (TNF-α) levels', 'serum 25(OH)D levels and skeletal muscle biomarkers (i.e. troponin, myoglobin, creatine kinase and lactic dehydrogenase', 'exercise myoglobin concentration', 'exercise creatine kinase activity']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.228986,24 h post exercise creatine kinase activity was significantly lower in supplemented group compared to placebo (p < 0.05).,"[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Żebrowska', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Mikołowska Street 72a, 40-065, Katowice, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Mikołowska Street 72a, 40-065, Katowice, Poland.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Stanula', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Mikołowska Street 72a, 40-065, Katowice, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Waśkiewicz', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Mikołowska Street 72a, 40-065, Katowice, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Łakomy', 'Affiliation': 'Institute of Sport Sciences, Academy of Physical Education in Katowice, Mikołowska Street 72a, 40-065, Katowice, Poland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Bezuglov', 'Affiliation': 'Department of Sport Medicine and Medical Rehabilitation, Sechenov First Moscow State Medical University (Sechenov University), 119435, Moscow, Russia.'}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Greece.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland. beat.knechtle@hispeed.ch.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00347-8']
233,32181747,"Pilot Study of a Multilevel Mobile Health App for Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV Among Youth: Randomized Controlled Trial.","BACKGROUND


Preventing and reducing substance use disorders, sexually transmitted infections (STIs)/HIV, and teen pregnancy, and the associated risk behaviors (ie, substance use and sexual risk behaviors) among youth remain public health priorities in the United States. Equally important is improving the uptake of STI/HIV testing among the youth. Mobile health (mHealth) apps may be a solution to ameliorate these public health concerns; however, few mHealth preventive interventions have demonstrated efficacy in reducing substance use or sexual risk behaviors or improving the uptake of STI/HIV testing among the youth, particularly in clinic settings.
OBJECTIVE


This small-scale study aimed to examine the feasibility of conducting a pilot randomized controlled trial (RCT). We evaluated the effects of Storytelling 4 Empowerment (S4E), relative to enhanced usual practice, on the potential mechanisms by which behavior change occurs, namely clinician-youth risk communication, prevention knowledge, and substance use and sexual risk refusal self-efficacy. We also assessed the ability to measure targeted outcomes of past 30-day substance use (ie, alcohol, tobacco, and other drug use), condomless sex, and alcohol or drug use before sex, as well as the uptake of STI/HIV testing.
METHODS


Employing community-based participatory research principles, 50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan, randomized sequentially to either S4E or enhanced usual practice, and assessed at baseline, immediately postintervention, and 30 days postintervention. S4E consists of 3 modules, including alcohol and drug use, tobacco, and STI/HIV.
RESULTS


Relative to youth in the enhanced usual practice group, S4E participants demonstrated higher youth-clinician risk communication (mean 3.22, SD 1.67) and increases in prevention knowledge (∆ score mean 0.36, SD 0.51) and self-efficacy (∆ score mean 0.16, SD 0.47). In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84). The results also suggest a reduction in the proportion of youths who reported past 30-day condomless sex (Cohen h=0.18, 95% CI -0.38 to 0.74) and alcohol use before sex (Cohen h=0.44, 95% CI -0.12 to 1.00). Finally, the findings also demonstrated an increase in the proportion of youths who reported STI/HIV testing over time (Cohen h=0.16, 95% CI -0.39 to 0.72).
CONCLUSIONS


The findings suggest the feasibility of a small-scale pilot RCT. S4E demonstrated shifts in the hypothesized direction, reducing substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing among youth in a clinic setting. The findings suggest that a larger RCT may be warranted.
TRIAL REGISTRATION


ClinicalTrails.gov NCT03855410, https://clinicaltrials.gov/ct2/show/NCT03855410.",2020,"In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84).",['50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan'],"['Storytelling 4 Empowerment (S4E', 'S4E']","['proportions of past 30-day overall substance use', 'youth-clinician risk communication', 'self-efficacy', 'substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing', 'proportion of youths who reported STI/HIV testing over time', 'Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV', 'prevention knowledge', 'past 30-day alcohol']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562982', 'cui_str': 'Youth club (environment)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",50.0,0.112227,"In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cordova', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Munoz-Velazquez', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frania', 'Initials': 'F', 'LastName': 'Mendoza Lua', 'Affiliation': 'School of Social Service Administration, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fessler', 'Affiliation': 'Corner Health Center, Ypsilanti, MI, United States.'}, {'ForeName': 'Sydni', 'Initials': 'S', 'LastName': 'Warner', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Delva', 'Affiliation': 'School of Social Work, Boston University, Boston, MA, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Adelman', 'Affiliation': 'Corner Health Center, Ypsilanti, MI, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Acknowledgments, .'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'School of Social Work, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bauermeister', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.'}]",JMIR mHealth and uHealth,['10.2196/16251']
234,31974022,The drug purity discounting task: Ecstasy use likelihood is reduced by probabilistic impurity according to harmfulness of adulterants.,"BACKGROUND


Ecstasy typically contains adulterants in addition to, or in lieu of, MDMA which may pose a greater risk to users than MDMA itself. The current study aimed to evaluate the effectiveness of adulterant-related informational prompts in reducing Ecstasy use using a novel probability discounting task.
METHODS


An online sample of past-month Ecstasy users (N = 278) were randomized to one of four different framing prompt conditions: no prompt; a prompt describing MDMA's effects; a prompt describing adulterants as inert ""filler""; or a prompt describing adulterants as pharmacologically-active, potentially-harmful compounds. Each prompt contained general, potential public-health information that was not specifically related to subsequent behavioral tasks. All participants then completed an identical Drug Purity Discounting Task, in which they indicated the likelihood of using a sample of Ecstasy across different probabilities of the sample being impure, and then completed a hypothetical Ecstasy purchasing task.
RESULTS


Likelihood of Ecstasy use decreased as impurity probability increased across conditions. Ecstasy use likelihood was highest in the ""inert"" prompt condition, whereas pharmacologically-active adulterant or adulterant-nonspecific prompts resulted in comparably low likelihood of use. Ecstasy-use likelihood did not differ among conditions when the likelihood of sample impurity was 0. Ecstasy purchasing did not differ among groups. Inelastic purchasing was associated with greater likelihood of using potentially-impure Ecstasy.
CONCLUSIONS


Altogether, these data highlight the necessity of education regarding pharmacologically-active, rather than inert, adulterants in Ecstasy, and suggest that increased access to drug checking kits and services may mitigate some of the harms associated with Ecstasy use.",2020,Ecstasy purchasing did not differ among groups.,['An online sample of past-month Ecstasy users (N\u202f=\u202f278'],"['framing prompt conditions: no prompt; a prompt describing MDMA\'s effects; a prompt describing adulterants as inert ""filler""; or a prompt describing adulterants as pharmacologically-active, potentially-harmful compounds']","['Ecstasy purchasing', 'impurity probability']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}]","[{'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}]","[{'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",278.0,0.035662,Ecstasy purchasing did not differ among groups.,"[{'ForeName': 'Sean B', 'Initials': 'SB', 'LastName': 'Dolan', 'Affiliation': 'Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA. Electronic address: sdolan8@jhmi.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD 21224, USA. Electronic address: mwj@jhu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107772']
235,32204137,Application of video-based health education in improving mother's knowledge and attitudes about behavioral problems among preschool children.,"OBJECTIVE


To identify the effect of health education using video on mother's knowledge and attitudes about behavior problems among preschool children.
METHODS


This research was a quasi-experimental study with a pre-test-post-test control group design. The sampling technique was purposive sampling, and it was divided into an intervention group (n=61) and control group (n=61). The intervention group was given intervention using a two-dimensional animated video, while the control group used leaflets. Knowledge and attitudes of the mother were measured using a questionnaire. Data analysis used Wilcoxon, Mann-Whitney test, Kruskal-Walli, and logistic regression.
RESULTS


There was a significant difference in knowledge (p=0.004) and attitude (p=0.04) of the intervention group (video) compared to the control group (leaflet) with a Cohen value of knowledge (d=0.67) and attitude (d=0.55) that indicate a moderate size effect.
CONCLUSION


Health education using video increase knowledge and attitudes of mothers about the behavior problem of preschool children.",2020,"There was a significant difference in knowledge (p=0.004) and attitude (p=0.04) of the intervention group (video) compared to the control group (leaflet) with a Cohen value of knowledge (d=0.67) and attitude (d=0.55) that indicate a moderate size effect.
",['preschool children'],"['health education using video', 'video-based health education']",['knowledge (p=0.004) and attitude'],"[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0018701'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0196712,"There was a significant difference in knowledge (p=0.004) and attitude (p=0.04) of the intervention group (video) compared to the control group (leaflet) with a Cohen value of knowledge (d=0.67) and attitude (d=0.55) that indicate a moderate size effect.
","[{'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Romantika', 'Affiliation': 'Graduate School of Nursing, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Indonesia; Sekolah Tinggi Ilmu Kesehatan Karya Kesehatan, Indonesia. Electronic address: iwayanromantika@gmail.com.'}, {'ForeName': 'Lely', 'Initials': 'L', 'LastName': 'Lusmilasari', 'Affiliation': 'Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Indonesia.'}, {'ForeName': 'Yayi Suryo', 'Initials': 'YS', 'LastName': 'Prabandari', 'Affiliation': 'Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Indonesia.'}, {'ForeName': 'Syahrul', 'Initials': 'S', 'LastName': 'Syahrul', 'Affiliation': 'Department of Community and Family Nursing, Faculty of Nursing, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.071']
236,32204176,The effectiveness of motor-cognitive dual-task training in reducing risk falls on elderly.,"OBJECTIVE


The aging process causes a setback of various aspects of the body that makes the elderly vulnerable to fall. The dual-task exercise amalgamates physical and cognitive training together and induces synergistic effects. This study aims to determine the effect of dual-task training on the risk of falls on elderly.
METHOD


The method used was pre-experimental design with 3 times a week intervention for 4 weeks. Before and after treatment, respondents measured the level of balance and risk of falling using the Berg Balance Scale (BBS), Timed-Up-and-Go test (TUGT), and Tinetti Balance Assessment Tool.
RESULTS


The results showed an increase in the balance after 12 times of exercises. The risk of falls seems to decline after 12 treatments, and the highest reduction occurred after the first 6 treatments.
CONCLUSION


It can be concluded that dual-task motor-cognitive training is significantly influential in reducing risk falls on elderly.",2020,"Before and after treatment, respondents measured the level of balance and risk of falling using the Berg Balance Scale (BBS), Timed-Up-and-Go test (TUGT), and Tinetti Balance Assessment Tool.
",['risk falls on elderly'],"['dual-task motor-cognitive training', 'dual-task training', 'motor-cognitive dual-task training']","['risk of falls on elderly', 'level of balance and risk of falling using the Berg Balance Scale (BBS), Timed-Up-and-Go test (TUGT), and Tinetti Balance Assessment Tool']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1960377', 'cui_str': 'Assessment of sense of balance (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",,0.0096207,"Before and after treatment, respondents measured the level of balance and risk of falling using the Berg Balance Scale (BBS), Timed-Up-and-Go test (TUGT), and Tinetti Balance Assessment Tool.
","[{'ForeName': 'Nahdiah', 'Initials': 'N', 'LastName': 'Purnamasari', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Universitas Hasanuddin, Indonesia. Electronic address: purnamasarinahdiah@gmail.com.'}, {'ForeName': 'Farahdina', 'Initials': 'F', 'LastName': 'Bachtiar', 'Affiliation': 'Department of Physiotherapy, Universitas Pembangunan Nasional Veteran Jakarta, Indonesia.'}, {'ForeName': 'Arnis', 'Initials': 'A', 'LastName': 'Puspitha R', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Universitas Hasanuddin, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.110']
237,31650067,Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial.,"Fatigue is often one of the most commonly reported symptoms in prostate cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Moreover, inflammatory processes and changes related to the hypothalamic-pituitary-adrenal (HPA) axis and/or autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in prostate cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health. Herein, we describe the protocol of the ongoing 3-arm randomized controlled Health Empowerment & Recovery Outcomes (HERO) clincal trial. One hundred sixty-six prostate cancer survivors with fatigue are randomized to a modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition. Guided by biopsychosocial and psychoneuroimmunology models, we propose that TCQ, as compared to BT or UC will: i) reduce fatigue (primary outcome) in prostate cancer survivors; ii) reduce inflammation; and iii) regulate the expression of genes from two major functional clusters: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Assessments are conducted at baseline, the 6-week midpoint of the intervention, and 1 week, 3 months, and 12 months post-intervention. If our findings show that TCQ promotes recovery from prostate cancer and its treatment, this type of intervention can be integrated into survivorship care plans as the standard of care. The study's findings will also provide novel information about underlying biobehavioral mechanisms of cancer-related fatigue.
Trial registration number


NCT03326713; clinicaltrials.gov.",2019,"Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health.","['men with prostate cancer', 'One hundred sixty-six prostate cancer survivors with fatigue', 'prostate cancer survivors']","['TCQ', 'Tai Chi Qigong', 'modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition']","['Biobehavioral effects', 'sleep quality, and impairments in health-related quality of life']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0830083,"Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health.","[{'ForeName': 'Anita Y', 'Initials': 'AY', 'LastName': 'Kinney', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'Cindy K', 'Initials': 'CK', 'LastName': 'Blair', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Dolores D', 'Initials': 'DD', 'LastName': 'Guest', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.'}, {'ForeName': 'Julianne K', 'Initials': 'JK', 'LastName': 'Ani', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Harding', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Amorim', 'Affiliation': 'Department of Health, Exercise and Sports Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Tawny', 'Initials': 'T', 'LastName': 'Boyce', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rodman', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.'}, {'ForeName': 'C Graham', 'Initials': 'CG', 'LastName': 'Ford', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Rosenberg', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Foran', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Gardner', 'Affiliation': 'Department of Theatre, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, NJ, USA.'}, {'ForeName': 'Wadih', 'Initials': 'W', 'LastName': 'Arap', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, Semel Institute for Neurosciences, University of California Los Angeles, California, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100431']
238,31924120,Effectiveness of Extracorporeal Shockwave Therapy in the Treatment of Chronic Insertional Achilles Tendinopathy.,"BACKGROUND


Extracorporeal shockwave therapy (ESWT) has been proposed as a conservative treatment for insertional Achilles tendinopathy from limited evidence without placebo controls. Our objective was to assess the effectiveness of ESWT compared with sham controls in chronic insertional Achilles tendinopathy.
METHODS


A double-blind, randomized sham-controlled trial was conducted between 2016 and 2018. The inclusion criteria were patients aged 18 to 70 years diagnosed with chronic insertional Achilles tendinopathy who failed standard conservative treatment. After computerized randomization, patients were allocated into either low-energy ESWT or sham control. Pain, function, and other complaints were assessed using visual analog scale (VAS) and VAS foot and ankle (VAS-FA) at preintervention and weeks 2, 3, 4, 6, 12, and 24. Intention-to-treat analysis and repeated measurement were performed using STATA 15.0.
RESULTS


Sixteen patients in ESWT and 15 patients in sham control groups had nonsignificant different baseline characteristics with preintervention VAS (6.0 ± 2.6 vs 5.2 ± 2.2) and VAS-FA (64.8 ± 16.6 vs 65.3 ± 12.7). There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups. In addition, the ESWT group had significant improvement in VAS (2.9 ± 2.2) at weeks 4 to 12, and sham controls group had significantly improved VAS (2.3 ± 2.6) at weeks 12 to 24. Complications were found only after ESWT treatment.
CONCLUSION


There was no difference at 24 weeks with the use of low-energy ESWT for chronic insertional Achilles tendinopathy, especially in elderly patients. However, it may provide a short period of therapeutic effects as early as weeks 4 to 12.
LEVEL OF EVIDENCE


Level I, randomized controlled study.",2020,"There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups.","['2016 and 2018', 'Chronic Insertional Achilles Tendinopathy', 'elderly patients', 'patients aged 18 to 70 years diagnosed with chronic insertional Achilles tendinopathy who failed standard conservative treatment']","['ESWT', 'Extracorporeal shockwave therapy (ESWT', 'Extracorporeal Shockwave Therapy', 'low-energy ESWT or sham control']","['VAS, VAS-FA, and its domains', 'VAS', 'visual analog scale (VAS) and VAS foot and ankle (VAS-FA', 'Pain, function, and other complaints', 'Complications']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3838864', 'cui_str': 'Insertional Achilles tendinopathy (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.168507,"There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups.","[{'ForeName': 'Siwadol', 'Initials': 'S', 'LastName': 'Pinitkwamdee', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sukij', 'Initials': 'S', 'LastName': 'Laohajaroensombat', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jakrapong', 'Initials': 'J', 'LastName': 'Orapin', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Patarawan', 'Initials': 'P', 'LastName': 'Woratanarat', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Foot & ankle international,['10.1177/1071100719898461']
239,32227753,Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.,"BACKGROUND


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


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


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


In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","['Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease', 'patients with stable ischemic heart disease and moderate or severe ischemia']",['invasive treatment strategy (2295 participants) or a conservative strategy'],"['angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ', 'SAQ summary score (scores range', 'SAQ summary scores', 'angina-related health status']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.248293,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Khaula', 'Initials': 'K', 'LastName': 'Baloch', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916370']
240,32204180,The effect of pediatric neurology physiotherapy run technique on walking ability of children with cerebral palsy.,"INTRODUCTION


Cerebral palsy is one of the conditions that usually cause disability in children. One of its symptoms is the walking problem. The purpose of this study is to examine the effectivity of Pediatric Physiotherapy Run Technique (PPRT) in improving walking ability of children with cerebral palsy.
METHODS


This is a pre-experimental study with time-series design. Twenty participants were included in this study. The outcome measure used was motor gross function measure (MGFM) walking dimension, which measured at baseline and after three times and nine times of PPRT session. Data were analyzed using repeated measure ANOVA.
RESULTS


The results of this study showed that there is a significantly different (p<0.05) between pre, three times and nine times. The nine times is significantly higher than the baseline.
CONCLUSION


Children with cerebral palsy may benefit from the PPRT program to improve their walking capacity.",2020,"The results of this study showed that there is a significantly different (p<0.05) between pre, three times and nine times.","['children with cerebral palsy', 'children', 'Children with cerebral palsy', 'Twenty participants were included in this study']","['Pediatric Physiotherapy Run Technique (PPRT', 'pediatric neurology physiotherapy run technique', 'PPRT program']","['motor gross function measure (MGFM) walking dimension, which measured at baseline and after three times and nine times of PPRT session']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0279167', 'cui_str': 'Pediatric neurology'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.016736,"The results of this study showed that there is a significantly different (p<0.05) between pre, three times and nine times.","[{'ForeName': 'Djohan', 'Initials': 'D', 'LastName': 'Aras', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Hasanuddin University, Makassar, Indonesia. Electronic address: djohanaras.da@gmail.com.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.114']
241,32204188,The effect of holothuria scabra on the level of docosahexaenoic acid in breast milk with preterm birth.,"OBJECTIVE


The objective of the research was to determine the giving of Holothuria scabra on the level of Docoxahexaenoic Acid (DHA) of breast milk with preterm chilbirth.
METHODS


The research was a quasi experimental study with control group design. The samples were postpartum mothers with preterm childbirth consisted of 40 people divided into two groups. Postpartum mothers given Holothuria scabra capsule were intervention group and the postpartum mothers not given Holothuria scabra were control group. The sample of mother's milk of pretest of each group was taken in the seventh day and seven day later the sample was taken 3cc. Intervention was done for 7 days per sample with 3 times dosage consisted of 2 capsules per day. The sample of breast milk was examined with Human DHA ELISA kit. The data were analyzed using Mann-Whitney test and Wilcoxon test.
RESULTS


The results of the research indicated the difference of DHA level between intervention group and control group with a value of p=value 0.006. After the intervention, the average increase was 187.02μg/mL for intervention group and 7.05μg/mL for control group with a value of 1151.04μg/mL.",2020,Postpartum mothers given Holothuria scabra capsule were intervention group and the postpartum mothers not given Holothuria scabra were control group.,"['postpartum mothers with preterm childbirth consisted of 40 people divided into two groups', 'breast milk with preterm birth', 'Postpartum mothers given Holothuria scabra capsule were intervention group and the postpartum mothers not given Holothuria scabra were control group']","['holothuria scabra', 'docosahexaenoic acid']",['DHA level'],"[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1081121', 'cui_str': 'Holothuria'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1081121', 'cui_str': 'Holothuria'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",40.0,0.0298075,Postpartum mothers given Holothuria scabra capsule were intervention group and the postpartum mothers not given Holothuria scabra were control group.,"[{'ForeName': 'Nur Ismi', 'Initials': 'NI', 'LastName': 'Wahyuni', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, Indonesia. Electronic address: pmc@agri.unhas.ac.id.'}, {'ForeName': 'Suryani', 'Initials': 'S', 'LastName': ""As'ad"", 'Affiliation': 'Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Muh Nasrum', 'Initials': 'MN', 'LastName': 'Massi', 'Affiliation': 'Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.119']
242,18001802,Toremifene increases bone mineral density in men receiving androgen deprivation therapy for prostate cancer: interim analysis of a multicenter phase 3 clinical study.,"PURPOSE


We evaluated the effects of toremifene on bone mineral density, a surrogate for fracture risk, in men receiving androgen deprivation therapy for prostate cancer.
MATERIALS AND METHODS


In an ongoing, multicenter, phase 3 fracture prevention study 1,392 men 50 years or older with prostate cancer receiving androgen deprivation therapy were randomized to 80 mg toremifene per day or placebo. Bone mineral density of the lumbar spine, total hip and femoral neck was assessed using dual energy x-ray absorptiometry. In this planned interim analysis of the first 197 subjects we compared bone mineral density changes from baseline to month 12 between the placebo and toremifene groups.
RESULTS


Compared with the placebo group men in the toremifene group had significant increases in bone mineral density at each evaluated skeletal site. Lumbar spine bone mineral density decreased 0.7% in the placebo group and increased 1.6% in the toremifene group (between group comparison p <0.001). Total hip bone mineral density decreased 1.3% in the placebo group and increased 0.7% in the toremifene group (p = 0.001). Femoral neck bone mineral density decreased 1.3% in the placebo group and increased 0.2% in the toremifene group (p = 0.009). Between group differences in the change in bone mineral density from baseline to month 12 were 2.3%, 2.0% and 1.5% for the lumbar spine, total hip and femoral neck, respectively.
CONCLUSIONS


Toremifene significantly increased hip and spine bone mineral density in men receiving androgen deprivation therapy for prostate cancer. The effect of toremifene on the fracture risk is being assessed in the ongoing randomized, controlled trial.",2008,Compared with the placebo group men in the toremifene group had significant increases in bone mineral density at each evaluated skeletal site.,"['197 subjects', 'men receiving androgen deprivation therapy for prostate cancer', '1,392 men 50 years or older with prostate cancer receiving androgen deprivation therapy']","['Toremifene', 'placebo', 'toremifene per day or placebo', 'toremifene']","['hip and spine bone mineral density', 'Bone mineral density of the lumbar spine, total hip and femoral neck', 'Total hip bone mineral density', 'bone mineral density', 'bone mineral density changes', 'Lumbar spine bone mineral density', 'fracture risk', 'Femoral neck bone mineral density']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0076836', 'cui_str': 'Toremifene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1392.0,0.244633,Compared with the placebo group men in the toremifene group had significant increases in bone mineral density at each evaluated skeletal site.,"[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts 02114, USA. smith.matthew@mgh.harvard.edu'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Malkowicz', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Forrest', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sieber', 'Affiliation': ''}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Barnette', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Steiner', 'Affiliation': ''}]",The Journal of urology,[]
243,31105044,Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake.,"We investigated whether ultra-processed foods affect energy intake in 20 weight-stable adults, aged (mean ± SE) 31.2 ± 1.6 years and BMI = 27 ± 1.5 kg/m 2 . Subjects were admitted to the NIH Clinical Center and randomized to receive either ultra-processed or unprocessed diets for 2 weeks immediately followed by the alternate diet for 2 weeks. Meals were designed to be matched for presented calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Energy intake was greater during the ultra-processed diet (508 ± 106 kcal/day; p = 0.0001), with increased consumption of carbohydrate (280 ± 54 kcal/day; p < 0.0001) and fat (230 ± 53 kcal/day; p = 0.0004), but not protein (-2 ± 12 kcal/day; p = 0.85). Weight changes were highly correlated with energy intake (r = 0.8, p < 0.0001), with participants gaining 0.9 ± 0.3 kg (p = 0.009) during the ultra-processed diet and losing 0.9 ± 0.3 kg (p = 0.007) during the unprocessed diet. Limiting consumption of ultra-processed foods may be an effective strategy for obesity prevention and treatment.",2019,"0.0004), but not protein (-2 ± 12 kcal/day; p = 0.85).","['20 weight-stable adults, aged (mean\xa0± SE) 31.2\xa0± 1.6 years and', 'Subjects were admitted to the NIH Clinical Center']","['ultra-processed foods affect energy intake', 'Ad Libitum Food Intake', 'ultra-processed or unprocessed diets', 'Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain']","['Weight changes', 'increased consumption of carbohydrate', 'Energy intake']","[{'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.0408081,"0.0004), but not protein (-2 ± 12 kcal/day; p = 0.85).","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hall', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA. Electronic address: kevinh@nih.gov.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ayuketah', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brychta', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cassimatis', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Chung', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Costa', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Courville', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Darcey', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fletcher', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Ciaran G', 'Initials': 'CG', 'LastName': 'Forde', 'Affiliation': 'Singapore Institute for Clinical Sciences, Singapore, Singapore.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Gharib', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Juen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Paule V', 'Initials': 'PV', 'LastName': 'Joseph', 'Affiliation': 'National Institute of Nursing Research, Bethesda, MD, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGehee', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ouwerkerk', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Raisinger', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rozga', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stagliano', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Walter', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}]",Cell metabolism,['10.1016/j.cmet.2019.05.008']
244,32284339,Neurofeedback-Linked Suppression of Cortical β Bursts Speeds Up Movement Initiation in Healthy Motor Control: A Double-Blind Sham-Controlled Study.,"Abnormally increased β bursts in cortical-basal ganglia-thalamic circuits are associated with rigidity and bradykinesia in patients with Parkinson's disease. Increased β bursts detected in the motor cortex have also been associated with longer reaction times (RTs) in healthy participants. Here we further hypothesize that suppressing β bursts through neurofeedback training can improve motor performance in healthy subjects. We conducted a double-blind sham-controlled study on 20 human volunteers (10 females) using a sequential neurofeedback-behavior task with the neurofeedback reflecting the occurrence of β bursts over sensorimotor cortex quantified in real time. The results show that neurofeedback training helps healthy participants learn to volitionally suppress β bursts in the sensorimotor cortex, with training being accompanied by reduced RT in subsequent cued movements. These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery. In addition, RTs correlated with the rate and accumulated duration of β bursts in the contralateral motor cortex before the go-cue, but not with averaged β power. The reduced RTs induced by neurofeedback training positively correlated with reduced β bursts across all tested hemispheres. These results strengthen the link between the occurrence of β bursts in the sensorimotor cortex before the go-cue and slowed movement initiation in healthy motor control. The results also highlight the potential benefit of neurofeedback training in facilitating voluntary suppression of β bursts to speed up movement initiation. SIGNIFICANCE STATEMENT  This double-blind sham-controlled study suggested that neurofeedback training can facilitate volitional suppression of β bursts in sensorimotor cortex in healthy motor control better than sham feedback. The training was accompanied by reduced reaction time (RT) in subsequent cued movements, and the reduced RT positively correlated with the level of reduction in cortical β bursts before the go-cue, but not with average β power. These results provide further evidence of a causal link between sensorimotor β bursts and movement initiation and suggest that neurofeedback training could potentially be used to train participants to speed up movement initiation.",2020,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","['healthy subjects', '20 human volunteers (10 females', 'healthy participants', ""patients with Parkinson's disease"", 'healthy motor control']","['neurofeedback training', 'sequential neurofeedback-behaviour task']","['reaction time', 'rigidity and bradykinesia', 'reduced reaction time in subsequent cued movements', 'reduced reaction times', 'motor performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",20.0,0.0558813,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","[{'ForeName': 'Shenghong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Everest-Phillips', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clouter', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH huiling.tan@ndcn.ox.ac.uk.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0208-20.2020']
245,32178221,Effect of Lifestyle Intervention in the Concentration of Adipoquines and Branched Chain Amino Acids in Subjects with High Risk of Developing Type 2 Diabetes: Feel4Diabetes Study.,"INTRODUCTION


The global prevalence of type 2 diabetes (T2D) is increasing rapidly, especially in low- and middle-income countries and has a high number of associated comorbidities. Plasmatic concentrations of branched chain amino acids (BCAA) and retinol-binding protein 4 (RBP4) have been shown to be elevated in T2D subjects in cross-sectional studies. However, the effect of lifestyle community-based interventions on BCAA and RBP4 concentrations has not yet been analyzed.
MATERIAL AND METHODS


The Feel4Diabetes study is a school and community-based intervention that identified 360 European families with a high risk of developing T2D according to the FINDRISC questionnaire. Families were randomized in control and intervention groups were followed-up from 2016 to 2018. In the Spanish families, the concentration of BCAA and RBP4 was determined in 266 subjects (115 control and 151 intervention group) that attended the three time-point assessments by colorimetric and ELISA reaction, respectively.
RESULTS


Baseline BCAA levels showed positive correlations with the FINDRISC score and glucose impairment (baseline glucose, insulin, and glycated hemoglobin), body mass index, and body weight. The participants receiving the community-based intervention showed a significant decrease in glycated hemoglobin and BCAA levels compared to the control group ( p  = 0.011 and  p  < 0.001, respectively). However, baseline RBP4 did not show significant correlations with anthropometric and glycemic parameters, and no significant change was observed in anthropometric parameters and RBP4 concentrations throughout the follow-up.
CONCLUSION


A community-based intervention on lifestyle led to a significant reduction in BCAA levels regardless of weight loss. These findings suggest that this interventional approach could be promising in T2D prevention.",2020,The participants receiving the community-based intervention showed a significant decrease in glycated hemoglobin and BCAA levels compared to the control group (,"['type 2 diabetes ', 'T2D subjects in cross-sectional studies', '360 European families with a high risk of developing T2D according to the FINDRISC questionnaire', 'Subjects with High Risk of Developing Type 2 Diabetes']",['Lifestyle Intervention'],"['FINDRISC score and glucose impairment (baseline glucose, insulin, and glycated hemoglobin), body mass index, and body weight', 'concentration of BCAA and RBP4', 'glycated hemoglobin and BCAA levels', 'anthropometric parameters and RBP4 concentrations']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",266.0,0.0332728,The participants receiving the community-based intervention showed a significant decrease in glycated hemoglobin and BCAA levels compared to the control group (,"[{'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Lamiquiz-Moneo', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Bea', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Palacios-Pérez', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}, {'ForeName': 'Pilar De', 'Initials': 'P', 'LastName': 'Miguel-Etayo', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Universidad de Zaragoza, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza 50009, Spain.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'González-Gil', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Universidad de Zaragoza, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza 50009, Spain.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'López-Ariño', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Civeira', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Universidad de Zaragoza, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza 50009, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IIS Aragón), CIBERCV, Universidad de Zaragoza, Zaragoza 50009, Spain.'}]",Cells,['10.3390/cells9030693']
246,32204226,The influence of preceptorship learning method on Leopold examination skill on midwifery students.,"OBJECTIVE


This study aimed to analyze the effect of preceptorship learning methods on enhancing Leopold's examination skills.
METHOD


It was an experimental study, the number of subjects in this study initially was 80 subjects, including 40 subjects for the preceptorship (intervention) class and 40 subjects for the demonstration (control) class with sampling using purposive sampling techniques according to predetermined inclusion criteria. However, 77 students were successfully analyzed because of a drop out in the demonstration group (control). All students who participated in this study were previously given a pre-test then the researchers chose and set the intervention class and the control class. Leopold skill was given using preceptorship learning methods for intervention group and demonstration learning methods for control classes for three meetings and subsequently given a post-test, data is presented in the form of a group table, and the statistical test used is the Chi-Square Test.
RESULTS


Table 2 shows the increasing of Leopold skill after intervention, before intervention there were no students who had good grades in both intervention groups but after the intervention as many as 36 people (72%) received good grades in the preceptorship group while in the demonstration group 14 people (28%) had good grades.
CONCLUSION


Improved student skills to be good, the frequency is higher in those given preceptorship when compared to demonstrations.",2020,"RESULTS


Table 2 shows the increasing of Leopold skill after intervention, before intervention there were no students who had good grades in both intervention groups but after the intervention as many as 36 people (72%) received good grades in the preceptorship group while in the demonstration group 14 people (28%) had good grades.
","['77 students', 'number of subjects in this study initially was 80 subjects, including 40 subjects for the preceptorship (intervention) class and 40 subjects for the demonstration (control) class with sampling using purposive sampling techniques according to predetermined inclusion criteria', 'midwifery students']","['preceptorship learning methods', 'preceptorship learning method']",['Leopold skill'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}]","[{'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[],77.0,0.0167927,"RESULTS


Table 2 shows the increasing of Leopold skill after intervention, before intervention there were no students who had good grades in both intervention groups but after the intervention as many as 36 people (72%) received good grades in the preceptorship group while in the demonstration group 14 people (28%) had good grades.
","[{'ForeName': '', 'Initials': '', 'LastName': 'Ernawati', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Esther Sanda', 'Initials': 'ES', 'LastName': 'Manapa', 'Affiliation': 'Faculty of Marine Science and Fisheries, Hasanuddin University, Indonesia. Electronic address: esmanapa@gmail.com.'}, {'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Muh Nasrum', 'Initials': 'MN', 'LastName': 'Massi', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.150']
247,32204259,Physical activity in affecting hemoglobin changes (Hb) in adolescent females received Moringa oleifera (MO) supplementation in Jeneponto.,"OBJECTIVE


This study aimed to investigate the role of physical activity in the Hb level of adolescent girls who previously supplemented with the Moringa oleifera (MO) powder in Jeneponto District.
METHOD


This study was a quasi-experiment study with pre- and post-test control group design. It was conducted in four (4) senior high schools in Tamalate subdistrict, where anemia among adolescent girls is more prevalent compared to other subdistricts. Senior High School no 2, Babussalam DDI Kassi School, Vocational High School of Persada and Islamic High School of Darul I'tisham were purposively selected representing the public and private school in Jeneponto Regency. A total of 48 respondents divided into two groups, MO group (receiving MO powder with 2×2 of 500mg capsule) and control group (without treatment), were observed for three months. Hb samples were collected twice with Finger Prick method using HemoCue. Mann-Whitney and Wilcoxon test were performed to analyze the result.
RESULTS


There was no difference in characteristic variables between the treatment and the control group. This study shows that the average percentage of nutrient intakes was varied across the type of nutrients. The lowest was protein intake (1.85%) while the highest was vitamin A (27.22%). Linear regression analysis shows that physical activity did not change Hb levels (p=0.11) with R 2  was 0.054.
CONCLUSION


In summary, it was found that physical activity did not significantly affect Hb changes, as this factor only has a small contribution. Intensive monitoring and observation should be promoted to keep the students doing physical activity. Thus, they maybe protected to the risk of anemia.",2020,"Linear regression analysis shows that physical activity did not change Hb levels (p=0.11) with R 2  was 0.054.
","['adolescent girls who previously supplemented with the Moringa oleifera (MO) powder in Jeneponto District', ""Senior High School no 2, Babussalam DDI Kassi School, Vocational High School of Persada and Islamic High School of Darul I'tisham were purposively selected representing the public and private school in Jeneponto Regency"", 'adolescent females received Moringa oleifera (MO) supplementation in Jeneponto']",[],"['physical activity', 'change Hb levels', 'characteristic variables']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0949952', 'cui_str': 'Drumsticktree'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012133', 'cui_str': 'Didanosine'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.014472,"Linear regression analysis shows that physical activity did not change Hb levels (p=0.11) with R 2  was 0.054.
","[{'ForeName': '', 'Initials': '', 'LastName': 'Arini', 'Affiliation': 'Midwifery Department, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Nutrition Department, Faculty of Public Health, Hasanuddin University, Indonesia. Electronic address: phunhas@gmail.com.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Midwifery Department, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Imam', 'Initials': 'AI', 'LastName': 'Arundhana', 'Affiliation': 'Nutrition Department, Faculty of Public Health, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.033']
248,31891225,Adherence as a predictor of dropout in Internet-based guided self-help for adults with binge-eating disorder and overweight or obesity.,"OBJECTIVE


Internet-based guided self-help (GSH-I) is an efficacious treatment for adults with binge-eating disorder (BED) and overweight or obesity. Although broadly accessible, high dropout from GSH-I has been reported. However, little is known about the factors explaining dropout from GSH-I, including patients' adherence to treatment.
METHOD


Within a randomized trial on the treatment of BED, adherence to 4-month GSH-I was objectively assessed in N = 89 patients with BED and overweight or obesity. Objective adherence and subjective treatment evaluation were evaluated as predictors of dropout from GSH-I, defined as having accessed 5 or less of 11 modules. Cutoffs with optimal sensitivity and specificity were derived using Receiver Operating Characteristics curves analysis, and baseline sociodemographic and clinical correlates were determined.
RESULTS


According to our definition, n = 22 (24.7%) patients were defined as dropouts. Results of the full logistic regression model accounted for 72% of the variance in dropout and all objective adherence parameters (i.e., number of messages exchanged, days with a completed food diary, and days spent per module), but not patients' subjective GSH-I evaluation significantly predicted dropout. Specifically, not completing the food diary in week 7 had maximized sensitivity and specificity in predicting dropout. Patients' body mass index was positively associated with the number of messages exchanged between patients and coaches. No other associations between baseline variables and objective adherence were found.
DISCUSSION


Patients at risk for dropout from GSH-I can be reliably identified via monitoring of objective adherence and may be provided with additional interventions to prevent dropout.",2020,I evaluation significantly predicted dropout.,"['adults with binge-eating disorder and overweight or obesity', 'N = 89 patients with BED and overweight or obesity', 'adults with binge-eating disorder (BED) and overweight or obesity']",['Internet-based guided self-help (GSH-I'],['Objective adherence and subjective treatment evaluation'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",89.0,0.0683713,I evaluation significantly predicted dropout.,"[{'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Puls', 'Affiliation': 'Integrated Research and Treatment Center Adiposity Diseases, Behavioral Medicine Unit, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ricarda', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Integrated Research and Treatment Center Adiposity Diseases, Behavioral Medicine Unit, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Friederich', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Gerlach', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'Department of Medical Biometry, Informatics and Epidemiology, Faculty of Medicine, University of Bonn, Bonn.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'NetUnion Sàrl, Lausanne, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'Coordinating Centre for Clinical Trials, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Zwaan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Hilbert', 'Affiliation': 'Integrated Research and Treatment Center Adiposity Diseases, Behavioral Medicine Unit, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig, Leipzig, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23220']
249,31160812,Closed-loop digital meditation improves sustained attention in young adults.,"Attention is a fundamental cognitive process that is critical for essentially all aspects of higher-order cognition and real-world activities. Younger generations have deeply embraced information technology and multitasking in their personal lives, school and the workplace, creating myriad challenges to their attention. While improving sustained attention in healthy young adults would be beneficial, enhancing this ability has proven notoriously difficult in this age group. Here we show that 6 weeks of engagement with a meditation-inspired, closed-loop software program (MediTrain) delivered on mobile devices led to gains in both sustained attention and working memory in healthy young adults. These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography. Our findings suggest the utility of delivering aspects of the ancient practice of focused-attention meditation in a modern, technology-based approach and its benefits on enhancing sustained attention.",2019,"These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography.","['healthy young adults', 'young adults']","['meditation-inspired, closed-loop software program (MediTrain) delivered on mobile devices led to gains in both sustained attention and working memory', 'Closed-loop digital meditation']",['positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0150277'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}]",,0.0377703,"These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. david.ziegler@ucsf.edu.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Simon', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Gallen', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Skinner', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Janowich', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Volponi', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Kornfield', 'Affiliation': 'Spirit Rock Meditation Center, Woodacre, CA, USA.'}, {'ForeName': 'Joaquin A', 'Initials': 'JA', 'LastName': 'Anguera', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. adam.gazzaley@ucsf.edu.'}]",Nature human behaviour,['10.1038/s41562-019-0611-9']
250,32275771,The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam.,"It is known that co-administration of CYP3A inducers may decrease the effectiveness of oral contraceptives containing progestins as mono-preparations or combined with ethinylestradiol. In a randomized clinical drug-drug interaction study, we investigated the effects of CYP3A induction on the pharmacokinetics of commonly used progestins and ethinylestradiol. Rifampicin was used to induce CYP3A. The progestins chosen as victim drugs were levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products, and drospirenone combined with ethinylestradiol. Postmenopausal women (n = 12-14 per treatment group) received, in fixed sequence, a single dose of the victim drug plus midazolam without rifampicin, with rifampicin 10 mg/day (weak induction), and with rifampicin 600 mg/day (strong induction). The effects on progestin exposure were compared with the effects on midazolam exposure (as a benchmark). Unbound concentrations were evaluated for drugs binding to sex hormone binding globulin. Weak CYP3A induction, as confirmed by a mean decrease in midazolam exposure by 46%, resulted in minor changes in progestin exposure (mean decreases: 15-37%). Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%). Namely, the magnitude of the observed induction effects varied from weak to strong. Our data might provide an impetus to revisit the currently applied clinical recommendations for oral contraceptives, especially for levonorgestrel and norethindrone-containing products, and they might give an indication as to which progestin could be used, if requested, by women taking weak CYP3A inducers-although it is acknowledged that the exact exposure-response relationship for contraceptive efficacy is currently unclear for most progestins.",2020,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).",['Postmenopausal women (n=12-14 per treatment group'],"['rifampicin', 'Rifampicin', 'levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products and drospirenone combined with ethinylestradiol', 'CYP3A induction', 'ethinylestradiol', 'victim drug plus midazolam without rifampicin, with rifampicin 10 mg/d (weak induction), and with rifampicin 600 mg/d (strong induction', 'midazolam', 'CYP3A']",[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0028356', 'cui_str': 'Norethindrone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",[],,0.0299347,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).","[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Wiesinger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Rottmann', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Nowotny', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Riecke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Gashaw', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Brudny-Klöppel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fricke', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Höchel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Friedrich', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1848']
251,31937608,Randomized Controlled Trial of Mobile Closed-Loop Control.,"OBJECTIVE


Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.
RESEARCH DESIGN AND METHODS


This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA 1c  <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L.
RESULTS


Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC ( n  = 65) versus SAP ( n  = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0];  P  < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1];  P  < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.
CONCLUSIONS


In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.",2020,"CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7%","['Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA 1c  <10.5% (91 mmol/mol', 'Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC ( n  = 65) versus SAP ( n  = 62); 125 participants completed the study']","['mobile CLC with sensor augmented pump (SAP) therapy', 'CLC over SAP', 'inControl AP', 'CLC', 'Mobile Closed-Loop Control']","['severe hypoglycemic event', 'CGM time']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",127.0,0.164715,"CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7%","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kovatchev', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': 'Sansum Diabetes Research Institute, Santa Barbara, CA.'}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': 'Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL jl_manuscripts@jaeb.org.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1310']
252,31700147,The effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury: an exploratory study.,"STUDY DESIGN


Experimental before-after design.
OBJECTIVES


The objectives of this study were to explore the effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury (SCI).
SETTING


Research laboratory.
METHODS


Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls. Each participant underwent seven protocols, including pressure (60 mmHg) with local cooling (∆t = -10 °C) for 20 min at three cooling rates (-0.5, -4, -10 °C/min), pressure with local cooling for 40 min, pressure with local heating (∆t = +10 °C), local cooling without pressure, and pressure without temperature changes. Each protocol included a 10-min baseline, a 20-min (or 40-min) loading period and a 20-min recovery. A compound sensor head consisting of laser Doppler and heating and cooling probes was used to measure sacral skin blood flow and temperature in the prone position. Blood flow responses were characterized by peak blood flow, recovery time, and total blood flow in the recovery period.
RESULTS


The results demonstrated that the cooling rate at -10 °C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min. There was a significant difference in the recovery time between the 20-min cooling compared with the 40-min cooling for the SCI group (p < 0.05).
CONCLUSIONS


Our findings provide initial evidence that local cooling rates affect skin blood flow responses under externally applied pressure in people with SCI.",2020,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"['people with spinal cord injury', 'people with spinal cord injury (SCI', 'people with SCI', 'Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls']","['laser Doppler and heating and cooling probes', 'local cooling rates']","['peak blood flow, recovery time, and total blood flow', 'cooling rate at -10', 'smaller skin blood flow response', 'cooling rate', 'sacral skin blood flow and temperature', 'recovery time', 'Blood flow responses']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",17.0,0.0858534,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"[{'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. yjan@illinois.edu.'}]",Spinal cord,['10.1038/s41393-019-0378-x']
253,30903276,Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial.,"BACKGROUND


Insufficient vascular supply is one of the main causes of anastomotic leak in colorectal surgery. Intraoperative indocyanine-green (ICG) angiography has been shown to provide information on tissue perfusion, identifying a well-perfused location for colonic and rectal transections, and thus possibly reducing the leak rate. Aim of this study was to evaluate the usefulness of intraoperative assessment of anastomotic perfusion using ICG angiography in patients undergoing left-sided colon or rectal resection with colorectal anastomosis.
METHODS


This randomized trial involved 252 patients undergoing laparoscopic left-sided colon and rectal resection randomized 1:1 to intraoperative ICG or to subjective visual evaluation of the bowel perfusion without ICG. The primary aim was to assess whether ICG angiography could lead to a reduction in anastomotic leak rate. Secondary outcomes were possible changes in the surgical strategy and postoperative morbidity.
RESULTS


After randomization, 12 patients were excluded. Accordingly, 240 patients were included in the analysis; 118 were in the study group, and 122 in the control group. ICG angiography showed insufficient perfusion of the colic stump, which led to extended bowel resection in 13 cases (11%). An anastomotic leak developed in 11 patients (9%) in the control group and in 6 patients (5%) in the study group (p = n.s.).
CONCLUSIONS


Intraoperative ICG fluorescent angiography can effectively assess vascularization of the colic stump and anastomosis in patients undergoing colorectal resection. This method led to further proximal bowel resection in 13 cases, however, there was no statistically significant reduction of anastomotic leak rate in the ICG arm.
CLINICAL TRIAL


ClinicalTrials.gov NCT02662946.",2020,"This method led to further proximal bowel resection in 13 cases, however, there was no statistically significant reduction of anastomotic leak rate in the ICG arm.
","['12 patients were excluded', 'patients undergoing left-sided colon or rectal resection with colorectal anastomosis', 'patients undergoing laparoscopic colorectal resection', '240 patients were included in the analysis; 118 were in the study group, and 122 in the control group', '252 patients undergoing laparoscopic left-sided colon and rectal resection randomized 1:1 to', 'patients undergoing colorectal resection']","['Intraoperative angiography with indocyanine green', 'Intraoperative ICG fluorescent angiography', 'intraoperative ICG or to subjective visual evaluation of the bowel perfusion without ICG', 'Intraoperative indocyanine-green (ICG) angiography', 'ICG angiography']","['anastomotic leak rate', 'anastomotic leak', 'surgical strategy and postoperative morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0278307', 'cui_str': 'Coloproctostomy (procedure)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0430879', 'cui_str': 'Indocyanine green angiography (procedure)'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",252.0,0.278469,"This method led to further proximal bowel resection in 13 cases, however, there was no statistically significant reduction of anastomotic leak rate in the ICG arm.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'De Nardi', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. denardi.paola@hsr.it.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Elmore', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Maggi', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Maggiore', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': ""Department of Surgery, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Cassinotti', 'Affiliation': ""Department of Surgery, IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Fumagalli', 'Affiliation': 'Chirurgia Generale 2, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gardani', 'Affiliation': 'Chirurgia Generale 2, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Pascale', 'Affiliation': 'Chirurgia Generale 2, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Parise', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vignali', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Rosati', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}]",Surgical endoscopy,['10.1007/s00464-019-06730-0']
254,32270496,Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan.,"BACKGROUND


Oliguria is a frequent trigger for administering a fluid bolus, but the effect of fluid bolus in improving urine output is inadequately demonstrated. Here, we summarize the protocol and detailed statistical analysis plan of the randomized, controlled RESPONSE trial comparing follow-up as the experimental group and a 500 mL crystalloid fluid bolus as the control group for oliguria in critically ill oliguric patients.
METHODS


Our trial is an investigator-initiated, randomized, controlled, pilot trial conducted in three ICUs in two centers. We aim to randomize 1:1 altogether 130 hemodynamically stable oliguric patients either to a 2-hour follow-up without interventions or to receive a crystalloid bolus of 500 mL over 30 minutes. The primary outcome is the change in individual urine output during the 2-hour period compared to 2 hours preceding randomization. Doubling of the urine output is considered clinically significant. Additionally, we record the duration of oliguria, physiological and biochemical variables, adverse events, and the incidences of acute kidney injury and renal replacement therapy.
CONCLUSIONS


Oliguria is a frequent trigger for potentially harmful fluid loading. Therefore, the RESPONSE trial will give information of the potential effect of fluid bolus on oliguria in critically ill patients.
TRIAL REGISTRATION


clinical.trials.gov, NCT02860572.",2020,130 hemodynamically stable oliguric patients either to a 2-hour follow-up without interventions or to receive a crystalloid bolus of 500 mL over 30 minutes.,"['130 hemodynamically stable oliguric patients', 'critically ill patients', 'critically ill oliguric patients']",[],"['change in individual urine output', 'duration of oliguria, physiological and biochemical variables, adverse events, and the incidences of acute kidney injury and renal replacement therapy']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",130.0,0.334481,130 hemodynamically stable oliguric patients either to a 2-hour follow-up without interventions or to receive a crystalloid bolus of 500 mL over 30 minutes.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Inkinen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Central Finland Central Hospital, Central Finland Health Care District, Jyväskylä, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Selander', 'Affiliation': 'Science Service Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Valkonen', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Bäcklund', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wennervirta', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Pulkkinen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Central Finland Central Hospital, Central Finland Health Care District, Jyväskylä, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13599']
255,31587271,Interventions for idiopathic toe walking.,"BACKGROUND


Idiopathic toe walking (ITW) is an exclusionary diagnosis given to healthy children who persist in walking on their toes after they should typically have achieved a heel-toe gait. The literature discusses conservative and surgical interventions using a variety of treatment modalities. Young children and children without a limitation in ankle dorsiflexion (the upwards movement of the foot towards the shin of the leg) are commonly treated with conservative interventions. Older children who continue toe walking and present with limitations in ankle dorsiflexion are sometimes treated with surgical procedures. This systematic review is needed to evaluate the evidence for any intervention for the treatment of ITW. The conclusions of this review may support decision making by clinicians caring for children with ITW. It may also assist families when deciding on treatment options for their children with ITW. Many of the treatments employed have financial implications for parents or healthcare services. This review also aims to highlight any deficits in the current research base.
OBJECTIVES


To assess the effects of conservative and surgical interventions in children with ITW, specifically effects on gait normalisation, ankle range of motion, pain, frequency of recurrence, and any adverse effects.
SEARCH METHODS


On 29 April 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL Plus, and PEDro. We searched the following registers of clinical trials for ongoing and recently completed trials: the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP, apps.who.int/trialsearch), and ClinicalTrials.gov (clinicaltrials.gov). We searched conference proceedings and other grey literature in the BIOSIS databases and System for Information on Grey Literature in Europe (OpenGrey, opengrey.eu). We searched guidelines via the Turning Research Into Practice database (TRIP, tripdatabase.com) and National Guideline Clearinghouse (guideline.gov). We did not apply language restrictions.
SELECTION CRITERIA


We considered randomised or quasi-randomised trials for inclusion in the review if they involved participants diagnosed with ITW gait in the absence of a medical condition known to cause toe walking, or associated with toe walking. As there is no universally accepted age group for ITW, this review includes ITW at any age, who have been toe walking for more than six months, who can or cannot walk with a heel-toe gait, and who may or may not have limited dorsiflexion of the ankle joint.
DATA COLLECTION AND ANALYSIS


We used standard Cochrane methodological procedures. The primary outcome was improvement in toe walking (defined as greater than 50% of time spent heel-toe walking). Secondary outcomes were active and passive range of motion of the ankle joint, pain, recurrence of ITW after treatment, and adverse events. We assessed the certainty of the evidence using the GRADE framework.
MAIN RESULTS


Four studies, comprising 104 participants, met the inclusion criteria. One study did not report data within the appropriate follow-up timeframe and data from two studies were insufficient for analysis. The single study from which we extracted data had 47 participants and was a randomised, controlled, parallel-group trial conducted in Sweden. It tested the hypothesis that combined treatment with serial casting and botulinum toxin type A (BTX) was more effective than serial casting alone in reducing ITW gait.This study found that more participants treated with BTX improved (defined as toe walking less than 50% of the time, as reported by parents) (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.57 to 2.55; 1 trial, 46 participants; very low-certainty evidence). However, there was little or no difference between groups in passive ankle joint dorsiflexion range of movement on the right with the knee extended (mean difference (MD) -1.48º, 95% CI -4.13 to 1.16; 1 trial, 47 participants), on the right with the knee flexed (MD -0.04º, 95% CI -1.80 to 1.73; 1 trial, 46 participants), on the left with the knee flexed (MD 1.07, 95% CI -1.22 to 3.37), or on the left with the knee extended (MD 0.05, 95% CI -0.91 to 1.91). Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants). In principle, MDs greater than zero (i.e.) positive values) would favour BTX and casting and negative values would favour casting alone. We have not reported effects as better or worse because all results were from evidence of very low certainty. We downgraded the certainty of evidence because of study limitations (outcome assessment was not blinded) and imprecision. Outcomes of pain and active range of motion were not reported in the included study.In terms of adverse events, calf pain was reported twice in the casting-only group and three times in the BTX group. There were three minor skin problems in each group and one reported case of pain directly after BTX injection. The report did not state if calf pain and skin irritation were from the same or different participants. The study authors reported that adverse events did not alter treatment adherence.
AUTHORS' CONCLUSIONS


The certainty of evidence from one study, which compared serial casting with serial casting with BTX for ITW in children, was too low for conclusions to be drawn. A further three studies reported outcomes relating to BTX, footwear, exercises, and different types of orthoses as interventions, however the outcome data were too limited to assess their effects.",2019,"Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants).","['idiopathic toe walking', 'participants diagnosed with ITW gait in the absence of a medical condition known to cause toe walking, or associated with toe walking', 'Young children and children', '47 participants', 'children with ITW', 'Older children', 'parents or healthcare services', 'healthy children who persist in walking on their toes after they should typically have achieved a heel-toe gait']","['conservative and surgical interventions', 'serial casting and botulinum toxin type A (BTX', 'BTX']","['gait normalisation, ankle range of motion, pain, frequency of recurrence, and any adverse effects', 'pain and active range of motion', 'calf pain and skin irritation', 'recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis', 'passive ankle joint dorsiflexion range of movement', 'parents) (risk ratio (RR', 'adverse events, calf pain', 'active and passive range of motion of the ankle joint, pain, recurrence of ITW after treatment, and adverse events', 'time spent heel-toe walking', 'ITW gait', 'skin problems', 'toe walking']","[{'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0427144', 'cui_str': 'Toe-walking gait (finding)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0231779', 'cui_str': 'Heel toe gait (finding)'}]","[{'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0236040', 'cui_str': 'Pain in calf (finding)'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C0427144', 'cui_str': 'Toe-walking gait (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0281822', 'cui_str': 'Skin problem (finding)'}]",47.0,0.264237,"Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants).","[{'ForeName': 'Antoni J', 'Initials': 'AJ', 'LastName': 'Caserta', 'Affiliation': 'Child and Family Team, Monash Health, 140-154 Sladen St, Cranbourne, Victoria, Australia, 3977.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Pacey', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fahey', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'Raoul Hh', 'Initials': 'RH', 'LastName': 'Engelbert', 'Affiliation': ''}, {'ForeName': 'Cylie M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012363.pub2']
256,32283048,An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the STRoke Interactive Virtual thErapy (STRIVE) intervention on upper-extremity clinical outcomes in community-dwelling stroke survivors.
DESIGN


Assessor-blinded randomized controlled trial.
SETTING


Study screening and testing was conducted in a university clinic. Participants completed the virtual therapy (VT) intervention in a community-based stroke support group setting.
PARTICIPANTS


Of 124 stroke survivors initially assessed, 60 participants were recruited (time poststroke, 13.4±8.9 y). Participants were allocated to either VT or control group using a block randomization design and were stratified by sex.
INTERVENTIONS


Participants were randomized to receive 8 weeks of VT or usual care. The intervention consisted of approximately 45 minutes of twice weekly VT training on the Jintronix Rehabilitation System.
MAIN OUTCOME MEASURES


Between-group differences in the Fugl-Meyer Upper Extremity scale and Action Research Arm Test score were joint primary outcomes in this study.
RESULTS


Significant between-group differences for the Fugl-Meyer Upper Extremity scale were seen at the end of the intervention (F 1, 1 =5.37, P=.02, d=0.41). No significant differences were observed with the Action Research Arm Test. No adverse events were reported.
CONCLUSIONS


We demonstrated clinically meaningful improvements in gross upper extremity motor function and use of the affected arm after a VT intervention delivered via a community-based stroke support group setting. This data adds to the contexts in which VT can be used to improve upper limb function. Use of VT in community-based rehabilitation in chronic stroke recovery is supported.",2020,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","['community-dwelling stroke survivors', 'Study screening and testing was conducted in a University clinic', 'Of 124 stroke survivors initially assessed, 60 participants were recruited (time post-stroke 13.4 ± 8.9 years']","['virtual therapy (VT) intervention in a community-based stroke support group setting', 'VT training', 'VT intervention delivered via a community-based stroke support group setting', 'VT', 'STRoke Interactive Virtual thErapy (STRIVE) intervention', 'VT or usual care', 'innovative STRoke Interactive Virtual thErapy (STRIVE) online platform']","['1) Fugl-Meyer Upper Extremity scale, and 2) Action Research Arm Test score', 'Fugl-Meyer Upper Extremity scale', 'adverse events']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0902791,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia; Faculty of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; National Health and Medical Research Council Stroke Rehabilitation and Brain Recovery Centre of Research Excellence, The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Bird', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Launceston, Australia; Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'Silverline Research, Brisbane, Australia; EuroMov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia; Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore. Electronic address: weipeng.teo@nie.edu.sg.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.011']
257,31701610,Cancer-related communication during sessions of family therapy at the end of life.,"OBJECTIVES


A goal of family-focused therapies in oncology is to help families communicate effectively about illness and its management. Yet there has been no examination of whether and how conjoint sessions are conducive to this process. In this study, we (a) described the extent of cancer-specific communication during family sessions at the end of life; (b) identified characteristics associated with SC; and (c) determined the association between SC and longer-term family bereavement outcomes.
METHODS


Data were collected as part of a randomized controlled trial of Family Focused Grief Therapy (FFGT) for advanced cancer patients and their families. Demographics, depressive symptoms, and family functioning were assessed at baseline. Cancer-specific communication, perceived responsiveness to communication, and therapeutic alliances were reported after each session. At 13-month bereavement, surviving families were assessed for symptoms of depression and prolonged grief disorder (PGD).
RESULTS


Participants were 257 advanced cancer patients and family members receiving FFGT at the end of life. On average, participants perceived significantly more cancer-related communication in session (SC) than at baseline. Both therapist-family and within-family alliances were associated with SC, especially for those with more severe depressive symptoms at baseline. Long-term outcomes were moderated by perceived responsiveness to in-session communication: for those who perceived high responsiveness, SC was associated with fewer depressive and PGD symptoms in bereavement.
CONCLUSIONS


Conjoint family sessions can effectively increase communication about cancer at the end of life. Clinicians should consider key contextual factors in their effort to facilitate this process: perceived responsiveness, family role, alliances with therapist, and within-family.",2020,"Both therapist-family, and within-family alliances were associated with SC, especially for those with more severe depressive symptoms at baseline.","['advanced cancer patients and their families', 'Participants were 257 advanced cancer patients and family members receiving']","['FFGT', 'Family Focused Grief Therapy (FFGT']","['depressive and PGD symptoms', 'Demographics, depressive symptoms and family functioning', 'symptoms of depression and prolonged grief disorder (PGD', 'severe depressive symptoms', 'Cancer-Related Communication']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033558', 'cui_str': 'PGD'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",257.0,0.109895,"Both therapist-family, and within-family alliances were associated with SC, especially for those with more severe depressive symptoms at baseline.","[{'ForeName': 'Talia I', 'Initials': 'TI', 'LastName': 'Zaider', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kissane', 'Affiliation': 'University of Notre Dame Australia, Sydney, NSW, AU.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Masterson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Psycho-oncology,['10.1002/pon.5268']
258,31703146,A feasible and acceptable multicultural psychosocial intervention targeting symptom management in the context of advanced breast cancer.,"OBJECTIVE


Advanced breast cancer patients around the world experience high symptom burden (ie, distress, pain, and fatigue) and are in need of psychosocial interventions that target symptom management. This study examined the feasibility, acceptability, and engagement of a psychosocial intervention that uses cognitive-behavioral strategies along with mindfulness and values-based activity to enhance patients' ability to manage symptoms of advanced disease in a cross-cultural setting (United States and Singapore). Pre-treatment to post-treatment outcomes for distress, pain, and fatigue were compared between intervention recipients and waitlisted controls.
METHODS


A pilot randomized controlled trial included women with advanced breast cancer (N = 85) that were recruited in the United States and Singapore. Participants either received the four session intervention or be put on waitlist. Descriptive statistics and effect size of symptom change were calculated.
RESULTS


The psychosocial intervention was found to be feasible as indicated through successful trial accrual, low study attrition (15% ), and high intervention adherence (77% completed all sessions). Acceptability (ie, program satisfaction and cultural sensitivity) and engagement to the study intervention (ie, practice of skills taught) were also high. Anxiety, depression, and fatigue scores remained stable or improved among intervention participants while the same symptoms worsened in the control group. In general, effect sizes are larger in the US sample compared with the Singapore sample.
CONCLUSIONS


The cognitive-behavioral, mindfulness, and values-based intervention is feasible, acceptable, and engaging for advanced breast cancer patients in a cross-cultural setting and has potential for efficacy. Further larger-scaled study of intervention efficacy is warranted.",2020,"The psychosocial intervention was found to be feasible as indicated through successful trial accrual, low study attrition (85% completion), and high intervention adherence (77%).","['Advanced breast cancer patients', 'Advanced Breast Cancer', 'women with advanced breast cancer (N=85) that were recruited in the United States and Singapore', 'advanced breast cancer patients']","['psychosocial intervention', 'Pre']","['Anxiety, depression, and fatigue scores', 'Acceptability (i.e., program satisfaction, cultural sensitivity) and engagement to the study intervention (i.e., practice of skills taught', 'distress, pain, and fatigue']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.023814,"The psychosocial intervention was found to be feasible as indicated through successful trial accrual, low study attrition (85% completion), and high intervention adherence (77%).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Teo', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jennifer Plumb', 'Initials': 'JP', 'LastName': 'Vilardaga', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Yee Pin', 'Initials': 'YP', 'LastName': 'Tan', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Winger', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Grace Meijuan', 'Initials': 'GM', 'LastName': 'Yang', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Shelby', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Arif H', 'Initials': 'AH', 'LastName': 'Kamal', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Kimmick', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Duke-NUS Medical School School of Medicine, Durham, North Carolina.'}]",Psycho-oncology,['10.1002/pon.5275']
259,31705591,A theory-driven psycho-educational intervention programme for gynaecological cancer patients during treatment trajectory: A randomised controlled trial.,"OBJECTIVE


This study aims to evaluate the effects of a theory-driven psycho-educational intervention programme on uncertainty in illness, anxiety, and sexual functioning in a cohort of Chinese patients with gynaecological cancer.
METHODS


Women with newly diagnosed gynaecological cancer (n = 202) received either a four-session, 12-week-long, culturally appropriate psycho-educational intervention programme (n = 102) or attention from intervener (n = 100) in a two-group randomised controlled trial. Patient-reported measures included Chinese version of Mishel's Uncertainty in Illness Scale (C-MUIS), Hospital Anxiety and Depression Scale (HADS)-Anxiety subscale, and Sexual Function-Vaginal Changes Questionnaire (SVQ). Data regarding uncertainty in illness and anxiety were collected at baseline and postintervention, while data on sexual functioning were collected postintervention.
RESULTS


Patients receiving psycho-educational intervention reported significantly greater reductions in ambiguity, inconsistency, and overall uncertainty in illness, as measured by C-MUIS (P < .01). They were also more likely to be sexually active (P = .037), report their partners having greater sexual interest (P = .008), and perceive a significantly greater level of intimacy (P = .001) in the SVQ.
CONCLUSIONS


Given the growing population of gynaecological cancer survivors and the universal side effects of the disease and its related treatments, the established design and content of the psycho-educational intervention programme should be incorporated into routine clinical practice.",2020,"They were also more likely to be sexually active (p=.037), report their partners having greater sexual interest (p=.008) and perceive a significantly greater level of intimacy (p=.001) in the SVQ.
","['Women with newly diagnosed gynaecological cancer (n=202) received either a', 'gynaecological cancer survivors', 'Chinese patients with gynaecological cancer', 'gynaecological cancer patients during treatment trajectory']","['A theory-driven psycho-educational intervention programme', '4-session, 12-week-long, culturally appropriate psycho-educational intervention programme (n=102) or attention from intervener', 'theory-driven psycho-educational intervention programme']","[""Chinese version of Mishel's Uncertainty in Illness Scale (C-MUIS), Hospital Anxiety and Depression Scale (HADS) "", 'Anxiety subscale and Sexual Function', 'level of intimacy', 'ambiguity, inconsistency and overall uncertainty in illness', 'illness, anxiety and sexual functioning', 'Vaginal Changes Questionnaire (SVQ']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.172271,"They were also more likely to be sexually active (p=.037), report their partners having greater sexual interest (p=.008) and perceive a significantly greater level of intimacy (p=.001) in the SVQ.
","[{'ForeName': 'Ka Ming', 'Initials': 'KM', 'LastName': 'Chow', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmen W H', 'Initials': 'CWH', 'LastName': 'Chan', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ka Yi', 'Initials': 'KY', 'LastName': 'Siu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Hedy K S', 'Initials': 'HKS', 'LastName': 'Fung', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Wai Man', 'Initials': 'WM', 'LastName': 'Sum', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, Hospital Authority, Hong Kong.'}]",Psycho-oncology,['10.1002/pon.5284']
260,31987975,"Randomized, Placebo-Controlled Clinical Trial Combining Pentoxifylline-Tocopherol and Clodronate in the Treatment of Radiation-Induced Plexopathy.","PURPOSE


Radiation-induced (RI) plexopathy is a rare peripheral nerve injury after radiation therapy for cancer. No treatment has been shown to slow its progression. A pentoxifylline-vitamin E combination significantly reduced RI fibrosis, and its association with clodronate (PENTOCLO) allowed healing of osteoradionecrosis and reduction of neurologic symptoms in phase 2 trials.
METHODS AND MATERIALS


A placebo-controlled, double-blind trial conducted in adults with RI limb plexopathy without cancer recurrence, randomized in 2 arms to PENTOCLO (pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days per week) or triple placebo. The primary outcome measure after 18 months of treatment was the neurologic Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability.
RESULTS


Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with placebo (group P), and 29 treated with the active drugs (group A); 46 patients presented an upper-limb and 12 a lower-limb plexopathy. The mean delay after irradiation was 26 ± 8 years, for patients with neurologic symptoms for 5 ± 5 years. The median global SOMA scores in the P and A groups, respectively, were 9 (range, 6-11) versus 9 (range, 8-11) at M 0  and 9 (range, 5-12) versus 10 (range, 6-11) at M 18  without any significant difference. Analysis of the secondary outcomes showed that SOMA score subdomains for pain and paresthesia were more affected in group A (not significant). The frequency of adverse events was similar in the 2 groups (81% of patients): slight expected vascular-gastrointestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
CONCLUSIONS


This first randomized drug trial in RI plexopathy failed to show a beneficial effect. More studies are needed in patients with less advanced disease and fewer confounding comorbidities and with a more sensitive measure to detect a therapeutic effect.",2020,"The frequency of adverse events was similar in the 2 groups (81% of patients): a slight expected vascular- gastro-intestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
","['group P) and 29 treated with the active drugs (group A); 46 patients presented an upper limb and 12 a lower limb plexopathy', 'adults with RI limb plexopathy without cancer recurrence', 'Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with']","['Placebo', 'Pentoxifylline-Tocopherol And Clodronate', 'Radiation-induced (RI) plexopathy', 'placebo', 'pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days/7) or triple placebo', 'clodronate', 'pentoxifylline-vitamin E combination', 'radiotherapy (RT']","['SOMA score subdomains for pain and paresthesia', 'RI fibrosis', 'median global SOMA scores', 'frequency of adverse events', 'vascular- gastro-intestinal symptoms', 'neurological Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability']","[{'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",59.0,0.437193,"The frequency of adverse events was similar in the 2 groups (81% of patients): a slight expected vascular- gastro-intestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
","[{'ForeName': 'Sylvie E', 'Initials': 'SE', 'LastName': 'Delanian', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Saint-Louis-Université de Paris, Oncologie-Radiothérapie, Paris, France. Electronic address: sylvie.delanian@aphp.fr.'}, {'ForeName': 'Timothee', 'Initials': 'T', 'LastName': 'Lenglet', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière- Sorbonne Université, Electrophysiologie, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Maisonobe', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière- Sorbonne Université, Electrophysiologie, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Saint-Louis-Université de Paris, Biostatistiques DBIM, Paris, France.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Pradat', 'Affiliation': ""Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière-Sorbonne Université, Neurologie and CNRS-INSERM, Laboratoire d'Imagerie Biomédicale, Paris, France.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.002']
261,32004582,Erectile Dysfunction and Absorbed Dose to Penile Base Structures in a Randomized Trial Comparing Ultrahypofractionated and Conventionally Fractionated Radiation Therapy for Prostate Cancer.,"PURPOSE


To study the relationships between absorbed dose to penile base structures and erectile dysfunction (ED) in patients treated with ultrahypofractionated (UHF) radiation therapy (RT) or conventionally fractionated (CF) RT for prostate cancer.
METHODS AND MATERIALS


This dose-response study comprises 673 patients (57%) of the 1180 per-protocol patients included in the HYPO-RT-PC trial (median follow-up 5, years), where patients were randomized to CF (39 × 2.0 Gy, 8 weeks) or UHF (7 × 6.1 Gy, 2.5 weeks). No androgen deprivation therapy was allowed. Only patients with erectile function sufficient for intercourse at baseline and complete RT data were included in this study. Erectile function was assessed by physician at regular follow-ups. The main endpoint was severe ED (ED s ). The penile bulb (PB) and crus were retrospectively delineated on the treatment planning computed tomography scans. Dose-volume descriptors were derived from EQD2 converted dose matrices (α/β = 3 Gy). Univariable and multivariable Cox proportional hazard regression and logistic regression were used to find predictors for ED S .
RESULTS


No significant difference in ED s  was found between CF and UHF. During the follow-up period, ED s  occurred in 27% of the patients in both treatment groups. Average (median) PB mean dose, D mean,  was 24.5 (20.2) in CF and 18.7 (13.1) Gy 3  in UHF. Age was the only significant predictor for ED s  in Cox analyses. All dose-volume variables contributed significantly in univariable logistic regression at 2-year follow-up. Age and near maximum dose (D 2% ) were significant predictors for ED s  in multivariable logistic regression analyses at both 1 and 2 years.
CONCLUSIONS


The frequency of ED S  was similar in the CF and UHF treatment groups. Age at radiation therapy was the strongest predictor for ED s , followed by dose to PB, and was most evident for younger patients. We propose D 2 %  <50 Gy 3  and D mean  <20 Gy 3  to the PB as the primary objectives to be applied in the treatment planning process.",2020,No significant difference in ED s  was found between CF and UHF.,"['Only patients with erectile function enough for intercourse at baseline and complete RT data', '673 patients (57%) of the 1180 per-protocol patients included in the', 'prostate cancer', 'patients treated with']","['ultra-hypofractionated and conventionally fractionated radiotherapy', 'XXXXXXXXXX', 'ultra-hypofractionated (UHF) radiotherapy (RT) or conventionally fractionated (CF) RT', 'CF']","['severe ED (ED s ', 'Erectile function', 'Erectile dysfunction', 'ED s', 'Average (median', 'frequency of ED S']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0336951,No significant difference in ED s  was found between CF and UHF.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rasmusson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden. Electronic address: elisabeth.rasmusson@med.lu.se.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gunnlaugsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Department of Laboratory Medicine, Faculty of Medicine, Clinical Pharmacology, Lund University, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Widmark', 'Affiliation': 'Department of Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department of Nursing, Umeå University Umeå, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellén', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Radiation Physics, Lund University, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.022']
262,32245908,"BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial.","OBJECTIVES


Adenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population.
DESIGN


BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken.
RESULTS


3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR.
CONCLUSION


EV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further.
TRIAL REGISTRATION NUMBERS


NCT03072472, ISRCTN30005319 and CPMS ID 33224.",2020,"No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics.","['16 English BowelScope screening centres', 'individuals aged 55 years', '3222 participants']","['English flexible sigmoidoscopy (FS) screening programme (BowelScope', 'Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB', 'EAB']","['mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events', 'PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics', 'BowelScope ADR', 'ADR', 'ADR, polyp detection rate (PDR']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",16.0,0.16272,"No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics.","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Rees', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK Colin.Rees@newcastle.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Wee Sing', 'Initials': 'WS', 'LastName': 'Ngu', 'Affiliation': 'Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, South Tyneside, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Stokes', 'Affiliation': 'Research, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Totton', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharp', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bastable', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Rutter', 'Affiliation': 'Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Hartlepool, Hartlepool, UK.'}, {'ForeName': 'Ajay Mark', 'Initials': 'AM', 'LastName': 'Verma', 'Affiliation': 'Gastroenterology, Kettering General Hospital NHS Foundation Trust, Kettering, Northamptonshire, UK.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology Research, Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walls', 'Affiliation': 'Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, South Tyneside, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2019-319621']
263,31591483,Role of appetitive phenotype trajectory groups on child body weight during a family-based treatment for children with overweight or obesity.,"OBJECTIVE


Emerging evidence suggests that individual appetitive traits may usefully explain patterns of weight loss in behavioral weight loss treatments for children. The objective of this study was to identify trajectories of child appetitive traits and the impact on child weight changes over time.
METHODS


Secondary data analyses of a randomized noninferiority trial conducted between 2011 and 2015 evaluated children's appetitive traits and weight loss. Children with overweight and obesity (mean age = 10.4; mean BMI z = 2.0; 67% girls; 32% Hispanic) and their parent (mean age = 42.9; mean BMI = 31.9; 87% women; 31% Hispanic) participated in weight loss programs and completed assessments at baseline, 3, 6,12, and 24 months. Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories. Linear mixed-effects models were used to identify the impact of group trajectory on child BMIz change over time.
RESULTS


One hundred fifty children and their parent enrolled in the study. The three-group trajectory model was the most parsimonious and included a high satiety responsive group (HighSR; 47.4%), a high food responsive group (HighFR; 34.6%), and a high emotional eating group (HighEE; 18.0%). Children in all trajectories lost weight at approximately the same rate during treatment, however, only the HighSR group maintained their weight loss during follow-ups, while the HighFR and HighEE groups regained weight (adjusted p-value < 0.05).
CONCLUSIONS


Distinct trajectories of child appetitive traits were associated with differential weight loss maintenance. Identified high-risk subgroups may suggest opportunities for targeted intervention and maintenance programs.",2019,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","['children', 'children with overweight or obesity', 'Children with overweight and obesity (mean age\u2009', 'One hundred fifty children and their parent enrolled in the study', ""2011 and 2015 evaluated children's appetitive traits and weight loss""]",['appetitive phenotype trajectory'],"['child body weight', 'differential weight loss maintenance', 'child BMIz change over time', 'weight loss', 'child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",150.0,0.0200187,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA. kboutelle@ucsd.edu.'}, {'ForeName': 'D Eastern', 'Initials': 'DE', 'LastName': 'Kang Sim', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0463-4']
264,32132264,The Right Temporoparietal Junction Is Causally Associated with Embodied Perspective-taking.,"A prominent theory claims that the right temporoparietal junction (rTPJ) is especially associated with embodied processes relevant to perspective-taking. In the present study, we use high-definition transcranial direct current stimulation to provide evidence that the rTPJ is causally associated with the embodied processes underpinning perspective-taking. Eighty-eight young human adults were stratified to receive either rTPJ or dorsomedial PFC anodal high-definition transcranial direct current stimulation in a sham-controlled, double-blind, repeated-measures design. Perspective-tracking (line-of-sight) and perspective-taking (embodied rotation) were assessed using a visuo-spatial perspective-taking task that required understanding what another person could see or how they see it, respectively. Embodied processing was manipulated by positioning the participant in a manner congruent or incongruent with the orientation of an avatar on the screen. As perspective-taking, but not perspective-tracking, is influenced by bodily position, this allows the investigation of the specific causal role for the rTPJ in embodied processing. Crucially, anodal stimulation to the rTPJ increased the effect of bodily position during perspective-taking, whereas no such effects were identified during perspective-tracking, thereby providing evidence for a causal role for the rTPJ in the embodied component of perspective-taking. Stimulation to the dorsomedial PFC had no effect on perspective-tracking or taking. Therefore, the present study provides support for theories postulating that the rTPJ is causally involved in embodied cognitive processing relevant to social functioning. SIGNIFICANCE STATEMENT  The ability to understand another's perspective is a fundamental component of social functioning. Adopting another perspective is thought to involve both embodied and nonembodied processes. The present study used high-definition transcranial direct current stimulation (HD-tDCS) and provided causal evidence that the right temporoparietal junction is involved specifically in the embodied component of perspective-taking. Specifically, HD-tDCS to the right temporoparietal junction, but not another hub of the social brain (dorsomedial PFC), increased the effect of body position during perspective-taking, but not tracking. This is the first causal evidence that HD-tDCS can modulate social embodied processing in a site-specific and task-specific manner.",2020,Stimulation to the dmPFC had no effect on perspective tracking or taking.,['Eighty-eight young human adults'],"['right temporoparietal junction (rTPJ', 'HD-tDCS', 'high-definition transcranial direct current stimulation (HD-tDCS', 'rTPJ', 'Perspective tracking (line-of-sight) and perspective taking (embodied rotation) were assessed using a visuo-spatial perspective taking (VPT) task', 'rTPJ or dorsomedial prefrontal (dmPFC) anodal HD-tDCS']",[],"[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",[],88.0,0.0306805,Stimulation to the dmPFC had no effect on perspective tracking or taking.,"[{'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029, a.martin11@uq.edu.au.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kessler', 'Affiliation': 'Aston Neuroscience Institute, School of Life and Health Sciences, Aston University, Birmingham, United Kingdom B4 7ET, and.'}, {'ForeName': 'Shena', 'Initials': 'S', 'LastName': 'Cooke', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2637-19.2020']
265,32179502,The effect of an emotional intelligence component program on happiness in patients with epilepsy.,"Emotional intelligence is a psychological component that may affect happiness level in patients with epilepsy. Given the high prevalence of depression in patients with epilepsy, as well as the limitations of studies in this regard in Iran, the aim of this study was to investigate the effect of an emotional intelligence component program on happiness in patients with epilepsy.
METHODS


This randomized clinical trial study conducted on 70 patients with epilepsy who were randomly divided into two experimental and control groups of 35 patients. Emotional Intelligence Training Based on Bar-On Combined Model was provided in eight 90-minute sessions for eight weeks. Data were collected using a two-part questionnaire: demographic data and the Oxford Happiness Questionnaire (OHQ).
RESULTS


The mean age of the subjects was 33.3 ± 10.4 years in the intervention group and 34.4 ± 9.3 years in the control group. The independent t-test results showed no significant difference between the two groups before the intervention (p = 0.195). The Mann-Whitney test results showed a significant difference between the two groups after emotional intelligence training (p < 0.001).
CONCLUSION


Overall, the findings of this study showed that emotional intelligence training led to improvement of happiness in patients with epilepsy. According to the results of the study, it is suggested that training based on emotional intelligence components be used as an approach to improve happiness level in patients with epilepsy.",2020,The independent t-test results showed no significant difference between the two groups before the intervention (p = 0.195).,"['The mean age of the subjects was 33.3\u202f±\u202f10.4\u202fyears in the intervention group and 34.4\u202f±\u202f9.3\u202fyears in the control group', 'patients with epilepsy', '70 patients with epilepsy who were randomly divided into two experimental and control groups of 35 patients']","['emotional intelligence training', 'emotional intelligence component program', 'Emotional Intelligence Training Based on Bar-On Combined Model']","['Oxford Happiness Questionnaire (OHQ', 'Emotional intelligence', 'emotional intelligence training']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligences'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligences'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",70.0,0.0148896,The independent t-test results showed no significant difference between the two groups before the intervention (p = 0.195).,"[{'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Hajisabbagh', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Fereidooni-Moghadam', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: m.fereidooni@nm.mui.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Etemadifar', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.106972']
266,32193093,Crossword puzzles improve learning of Palestinian nursing students about pharmacology of epilepsy: Results of a randomized controlled study.,"OBJECTIVE


This study was conducted to investigate if crossword puzzles as active learning tools can improve the knowledge retention of nursing students in pharmacology of epilepsy and improve their performance in writing the correct spelling of antiepileptic drugs (AEDs).
METHODS


The present study was a randomized controlled prospective parallel study in which a control group design with pretests and posttests were used among nursing students. Students were randomly allocated to either control group (n = 114) who received routine learning or intervention group (n = 110) who received crossword puzzles. Both control and intervention groups had to complete multiple-choice question (MCQs) and spelling pretests and posttests.
RESULTS


Scores of the MCQs and spelling pretests were not statistically different (p-value > 0.05) for participants in all achievement categories in both control and intervention groups. In the intervention group, scores in the first and second MCQs and spelling posttests were significantly higher than their corresponding scores in the pretest scores for participants from the all achievement categories (p-value < 0.05) and scores of the first and second MCQs and spelling posttests were not significantly different (p-value > 0.05). Data analyses showed that there were significant normalized changes between scores of students in across all achievement categories.
CONCLUSION


Findings of this study suggested that crossword puzzles were effective in improving the learning of nursing students about the pharmacology of epilepsy and writing correct spelling of AEDs. Educators should consider using crossword puzzles as active learning tools to improve knowledge of nursing students about the pharmacology of epilepsy.",2020,"In the intervention group, scores in the first and second MCQs and spelling posttests were significantly higher than their corresponding scores in the pretest scores for participants from the all achievement categories (p-value < 0.05) and scores of the first and second MCQs and spelling posttests were not significantly different (p-value > 0.05).","['nursing students', 'Palestinian nursing students about pharmacology of epilepsy']","['control group (n\u202f=\u202f114) who received routine learning or intervention group (n\u202f=\u202f110) who received crossword puzzles', 'Crossword puzzles']",[],"[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0282539', 'cui_str': 'Palestinians'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0423995', 'cui_str': 'Puzzled (finding)'}]",[],114.0,0.0208772,"In the intervention group, scores in the first and second MCQs and spelling posttests were significantly higher than their corresponding scores in the pretest scores for participants from the all achievement categories (p-value < 0.05) and scores of the first and second MCQs and spelling posttests were not significantly different (p-value > 0.05).","[{'ForeName': 'Ramzi', 'Initials': 'R', 'LastName': 'Shawahna', 'Affiliation': 'Department of Physiology, Pharmacology and Toxicology, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; An-Najah BioSciences Unit, Centre for Poisons Control, Chemical and Biological Analyses, An-Najah National University, Nablus, Palestine. Electronic address: ramzi_shawahna@hotmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jaber', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; An-Najah National University Hospital, An-Najah National University, Nablus, Palestine.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107024']
267,31950482,Effects of anaesthesia-induced hypotension and phenylephrine on plasma volume expansion by hydroxyethyl starch: A randomised controlled study.,"BACKGROUND


Changes in blood haemoglobin concentration indicate plasma volume expansion following hydroxyethyl starch (HES) infusion, but may be affected by vascular tone and HES-induced shedding of the endothelial surface layer (ESL). We hypothesised that anaesthesia-induced hypotension enhances changes in plasma volume as assessed by blood haemoglobin concentration (ΔPV Hb  , %) following HES infusion.
METHODS


Fifty-two patients undergoing abdominal surgery were randomised to receive a continuous infusion of saline (S group) or phenylephrine to restore vascular tone (P group) (n = 26 each). Both groups received an infusion of 8 mL/kg 6% HES solution after induction of general anaesthesia. We compared ΔPV Hb  at the end of fluid infusion (15 minutes) and 15 minutes later (30 minutes) between the two groups. We assessed changes in ESL structure by measuring plasma concentrations of hyaluronate and syndecan-1. P < .05 was considered statistically significant.
RESULTS


Mean arterial blood pressure was lower in the S group approximately by 30-40% compared to the P group (P < .001). ΔPV Hb  was larger in the S group compared to the P group at 15 minutes (24.9 [5.2] % vs 19.0 [5.2] %; P < .001) and 30 minutes (26.5 [5.9] % vs 16.9 [6.6] %; P < .001). There were no clinically significant differences in plasma concentrations of hyaluronate and syndecan-1 with time and between the groups.
CONCLUSIONS


Increased volume expansion of circulating plasma following HES infusion in anaesthesia-induced hypotension compared to when blood pressure is restored by phenylephrine may result from an attenuation of transcapillary fluid filtration, rather than ESL shedding. UMIN Clinical Trial Registration Number: UMIN000017394 (http://www.umin.ac.jp/ctr/index.htm).",2020,"There were noclinicallysignificant differences in plasma concentrations of hyaluronate and syndecan-1with time and betweenthe groups.
",['Fifty-two patients undergoing abdominal surgery'],"['hydroxyethyl starch', 'continuous infusion of saline (S group) or phenylephrine to restorevascular tone(P group', 'anaesthesia-induced hypotension and phenylephrine', 'infusion of 8 ml/kg 6% HES solution', 'hydroxyethyl starch (HES']","['plasma concentrations of hyaluronate and syndecan-1with time', 'blood haemoglobin concentration', 'Mean arterial blood pressure', 'plasma volume expansion', 'ΔPV Hb']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178695', 'cui_str': 'hyaluronate'}, {'cui': 'C0075691'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}]",52.0,0.44973,"There were noclinicallysignificant differences in plasma concentrations of hyaluronate and syndecan-1with time and betweenthe groups.
","[{'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Tatara', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, Hyogo, Japan.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13548']
268,30941550,"Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results.","PURPOSE


Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR.
METHODS


This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured.
RESULTS


At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014).
CONCLUSION


Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL.
TRIAL REGISTRY


Clinical trial number NCT02542085.",2020,"QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014).
","['From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7\xa0cm were recruited in 11 Finnish hospitals', 'incisional ventral hernia']","['Laparoscopic versus hybrid approach', 'LIVHR combined with defect closure (hybrid', 'laparoscopic (LG) or a hybrid (HG) repair group', 'LIVHR', 'Laparoscopic incisional ventral hernia repair (LIVHR']","['chronic pain scores and QoL', 'hernia recurrence', 'hernia recurrence and chronic pain', 'visual analogue scores for pain', 'physical functioning', 'hernia recurrence, chronic pain and poor quality of life (QoL', 'mean visual analogue scale (VAS', 'chronic pain and physical impairment', 'low hernia recurrence rates', 'bodily pain score', 'recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019326', 'cui_str': 'Ventral Hernia'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",193.0,0.254293,"QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014).
","[{'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Ahonen-Siirtola', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland. mirella.ahonen@oulu.fi.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Nevala', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Vironen', 'Affiliation': 'Department of Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Kössi', 'Affiliation': 'Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Pinta', 'Affiliation': 'Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Niemeläinen', 'Affiliation': 'Department of Surgery, Valkeakoski Regional Hospital, Valkeakoski, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Keränen', 'Affiliation': 'Department of Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Ward', 'Affiliation': 'Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Pälvi', 'Initials': 'P', 'LastName': 'Vento', 'Affiliation': 'Department of Surgery, Kymenlaakso Central Hospital, Kotka, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Karvonen', 'Affiliation': 'Department of Surgery, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Mäkelä', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}]",Surgical endoscopy,['10.1007/s00464-019-06735-9']
269,32271243,Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.,"BACKGROUND


Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.
METHODS


The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.
RESULTS


A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.
CONCLUSION


At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.",2020,"The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.
","['1261 patients', 'all-comers patients']","['biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent', 'ultrathin-strut sirolimus-eluting Orsiro stent', 'sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent', 'sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent']","['safety and efficacy', 'composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization', 'myocardial infarction', 'Cardiac death', 'definite stent thrombosis', 'target lesion revascularization', 'target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",1261.0,0.160871,"The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ellert', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg.'}, {'ForeName': 'Knud Nørregaard', 'Initials': 'KN', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Kahlert', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Svend Eggert', 'Initials': 'SE', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus.'}, {'ForeName': 'Henrik Steen', 'Initials': 'HS', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense.'}]",Coronary artery disease,['10.1097/MCA.0000000000000875']
270,32238992,Longitudinal Follow-up Survey of Effects of Oral Comprehensive Healthcare Measures on Early Childhood Caries.,"PURPOSE


To assess the effect of oral comprehensive healthcare on the prevalence of early childhood caries in urban areas of China.
MATERIALS AND METHODS


A total of 398 children aged 4-5 years from six different kindergartens in Qingdao were recruited to participate in a 1-year single-blind randomised controlled clinical trial. They were randomly assigned into either an experimental group (187 children) or a control group (211 children). The experimental group received comprehensive oral healthcare including oral health examinations, oral health education for children and their guardians, and local fluoride application and dental treatment, whereas children in the control group only received oral health examinations twice a year. The children's parents finished a comprehensive oral health questionnaire before and after the experiment. After a year, the oral health status of two groups of children was statistically analysed to determine the effect of oral comprehensive healthcare on early childhood caries.
RESULTS


After 1 year, the numbers of decayed teeth (dt), decayed tooth surfaces (ds), filled teeth (ft), and filled tooth surfaces (fs) in the experimental group were significantly lower than the control group (p <0.001). The dmft and dmfs were also significantly different between the two groups (p <0.05). Statistically significant differences were additionally shown in oral hygiene habits and eating habits of both the children and their parents in the two groups compared with 1 year before (all p <0.001).
CONCLUSION


Implementation of comprehensive oral healthcare measures both prevents and reduces early childhood caries.",2020,"Statistically significant differences were additionally shown in oral hygiene habits and eating habits of both the children and their parents in the two groups compared with 1 year before (all p <0.001).
","['early childhood caries in urban areas of China', 'Early Childhood Caries', '398 children aged 4-5 years from six different kindergartens in Qingdao']","['comprehensive oral healthcare including oral health examinations, oral health education for children and their guardians, and local fluoride application and dental treatment, whereas children in the control group only received oral health examinations twice a year', 'oral comprehensive healthcare', 'Oral Comprehensive Healthcare Measures']","['numbers of decayed teeth (dt), decayed tooth surfaces (ds), filled teeth (ft), and filled tooth surfaces', 'oral hygiene habits and eating habits']","[{'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}]",398.0,0.0352418,"Statistically significant differences were additionally shown in oral hygiene habits and eating habits of both the children and their parents in the two groups compared with 1 year before (all p <0.001).
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Quanchen', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huibin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43347']
271,31891601,Evaluation of a savings-led family-based economic empowerment intervention for AIDS-affected adolescents in Uganda: A four-year follow-up on efficacy and cost-effectiveness.,"BACKGROUND


Children who have lost a parent to HIV/AIDS, known as AIDS orphans, face multiple stressors affecting their health and development. Family economic empowerment (FEE) interventions have the potential to improve these outcomes and mitigate the risks they face. We present efficacy and cost-effectiveness analyses of the Bridges study, a savings-led FEE intervention among AIDS-orphaned adolescents in Uganda at four-year follow-up.
METHODS


Intent-to-treat analyses using multilevel models compared the effects of two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning. Total per-participant costs for each arm were calculated using the treatment-on-the-treated sample. Intervention effects and per-participant costs were used to calculate incremental cost-effectiveness ratios (ICERs).
FINDINGS


Among 1,383 participants, 55% were female, 20% were double orphans. Mean age was 12 years at baseline. At 48-months, BridgesPLUS significantly improved self-rated health, (0.25, 95% CI 0.06, 0.43), HIV knowledge (0.21, 95% CI 0.01, 0.41), self-concept (0.26, 95% CI 0.09, 0.44), and self-efficacy (0.26, 95% CI 0.09, 0.43) and lowered hopelessness (-0.28, 95% CI -0.43, -0.12); whereas Bridges improved self-rated health (0.26, 95% CI 0.08, 0.43) and HIV knowledge (0.22, 95% CI 0.05, 0.39). ICERs ranged from $224 for hopelessness to $298 for HIV knowledge per 0.2 standard deviation change.
CONCLUSIONS


Most intervention effects were sustained in both treatment arms at two years post-intervention. Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect. These findings contribute to the evidence supporting the incorporation of FEE interventions within national social protection frameworks.",2019,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"['AIDS-affected adolescents in Uganda', 'AIDS-orphaned adolescents in Uganda at four-year follow-up', 'Mean age was 12 years at baseline', 'Children who have lost a parent to HIV/AIDS, known as AIDS orphans', '1,383 participants, 55% were female, 20% were double orphans']","['savings-led FEE intervention', 'two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning', 'savings-led family-based economic empowerment intervention']","['Total per-participant costs', 'ICERs', 'lowered hopelessness', 'efficacy and cost-effectiveness', 'incremental cost-effectiveness ratios (ICERs', 'self-rated health', 'HIV knowledge', 'self-efficacy', 'Bridges improved self-rated health']","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",1383.0,0.147934,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Capasso', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shu-Huah Wang', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, School of Medicine, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}]",PloS one,['10.1371/journal.pone.0226809']
272,32204209,The effectiveness of technical guided imagery on pain intensity decreasing in breast cancer patients.,"OBJECTIVE


This aim of the study was to determine the effectiveness of guided imagery techniques to decrease pain intensity in patients with breast cáncer.
METHOD


This was a quantitative research with a quasi-experimental design with a total sampling of all breast cancer patients who experience pain in ambulatory surgery in the treatment room and the chemo room using Numeric Rating Scale (NRS) and the guided imagery as an intervention.
RESULTS


The results indicated guided imagery for pain intensity reduction was (p=0.000), pulse rate (p=0.005), and systolic blood pressure (p=0.000). Spearman correlation test indicated a change in pain intensity with changes in pulse rate (p=0.029, r=0.445), change in pain intensity of the systolic blood pressure (p=0.006, r=0.544), and changes in the pulse of the systolic blood pressure (p=0.000, r=0.809).
CONCLUSION


This study indicates a reduction of the pain after being carried out guided imagery technique compared to the control.",2020,"The results indicated guided imagery for pain intensity reduction was (p=0.000), pulse rate (p=0.005), and systolic blood pressure (p=0.000).","['breast cancer patients who experience pain in ambulatory surgery in the treatment room and the chemo room using Numeric Rating Scale (NRS) and the guided imagery as an intervention', 'breast cancer patients', 'patients with breast cáncer']","['technical guided imagery', 'guided imagery techniques']","['systolic blood pressure', 'pain intensity', 'pulse rate', 'guided imagery for pain intensity reduction', 'change in pain intensity of the systolic blood pressure']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0557823', 'cui_str': 'Treatment room (environment)'}, {'cui': 'C0222045'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0454046', 'cui_str': 'Imagery technique (regime/therapy)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.029395,"The results indicated guided imagery for pain intensity reduction was (p=0.000), pulse rate (p=0.005), and systolic blood pressure (p=0.000).","[{'ForeName': 'Ariyanti', 'Initials': 'A', 'LastName': 'Saleh', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia. Electronic address: ariyanti.saleh@gmail.com.'}, {'ForeName': 'Sitti Maryam', 'Initials': 'SM', 'LastName': 'Bachtiar', 'Affiliation': 'Akper Muhammadiyah Makassar, Makassar, Indonesia.'}, {'ForeName': 'Elly L', 'Initials': 'EL', 'LastName': 'Sjattar', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia.'}, {'ForeName': 'Eva Arna', 'Initials': 'EA', 'LastName': 'Abrar', 'Affiliation': 'STIKES Nani Hasanuddin, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.025']
273,32285979,Effectiveness of nicotine gum in preventing lapses in the face of temptation to smoke among non-daily smokers: a secondary analysis.,"BACKGROUND AND AIMS


Non-daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non-daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations.
DESIGN


Within a 6-week randomized, placebo-controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used.
SETTING


Smoking cessation research clinic in Pittsburgh, PA, USA.
PARTICIPANTS


A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation.
INTERVENTION


Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as-needed dosing instructions.
MEASUREMENTS


Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable.
FINDINGS


Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22-0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78-3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06).
CONCLUSIONS


When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non-daily smokers.",2020,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","['temptation to smoke among non-daily smokers', 'non-daily smokers', 'Smoking cessation research clinic in Pittsburgh, PA, USA', 'Participants reported 2,713 temptation episodes, 46.0% (1,248) of which resulted in smoking (lapsing', '255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation']","['nicotine gum', 'Nicotine gum (2 mg) vs placebo', 'nicotine gum, vs placebo', 'placebo', 'nicotine gum with placebo']","['overall abstinence', 'quitting smoking', 'odds of lapsing', 'ecological momentary assessment (EMA']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",,0.0231301,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15083']
274,31688817,Comparison of the Results of Primary Versus Repeat Hamstring Surgical Lengthening in Cerebral Palsy.,"BACKGROUND


Hamstring surgical lengthening (HSL) has been frequently performed for the correction of knee flexion deformity in cerebral palsy (CP), although recurrence is described in long-term follow-up. Repeat hamstring surgical lengthening (RHSL) can be an option for recurrent knee flexion deformity; however, the results of this approach are still controversial. The purpose of this study was to compare the results of primary HSL and RHSL in CP.
METHODS


Patients with spastic diplegic CP, Gross Motor Function Classification System levels I to III, underwent bilateral medial HSL with complete documentation in the gait laboratory before and after the intervention, were included in the study. A total of 229 subjects met the inclusion criteria and were divided into 2 groups: group A was formed by those who received medial HSL for the first time (185 patients), and group B was composed of individuals who underwent RHSL (44 patients). Clinical and kinematic parameters were evaluated before and after the intervention, and the results compared.
RESULTS


The groups were matched with regard to sex distribution, Gross Motor Function Classification System levels, and follow-up time (>2 y). Popliteal angle was reduced in groups A (60.3 to 51.4 degrees, P<0.001) and B (56.1 to 51.5 degrees, P=0.001) after the intervention. Knee flexion at initial contact was reduced from 40.8 to 28.9 degrees in group A (P<0.001) and from 40.4 to 35.1 degrees in group B (P=0.001). Reduction of minimum knee flexion in the stance phase (24.9 to 17.5 degrees, P<0.001) and improvement of the Gait Deviation Index (52.9 to 60.2, P<0.001) occurred only in group A. Anterior pelvic tilt (APT) increased in groups A (from 17 to 19.5 degrees, P<0.001) and B (from 14.9 to 19.4 degrees, P<0.001) after treatment. Finally, in the comparison between groups, the reduction of knee flexion at initial contact was more significant in group A (P<0.001), whereas the increase of APT was higher in group B.
CONCLUSIONS


In the present study, the improvement of knee extension during the stance phase was observed only after the primary medial HSL. Moreover, the increase of APT was more significant when RHSL was performed.
LEVEL OF EVIDENCE


Level III.",2020,"Reduction of minimum knee flexion in the stance phase (24.9 to 17.5 degrees, P<0.001) and improvement of the Gait Deviation Index (52.9 to 60.2, P<0.001) occurred only in group A. Anterior pelvic tilt (APT) increased in groups A (from 17 to 19.5 degrees, P<0.001) and B (from 14.9 to 19.4 degrees, P<0.001) after treatment.","['Cerebral Palsy', 'recurrent knee flexion deformity', '229 subjects met the inclusion criteria', 'Patients with spastic diplegic CP, Gross Motor Function Classification System levels I to III, underwent bilateral medial HSL with complete documentation in the gait laboratory before and after the intervention, were included in the study']","['medial HSL', 'Repeat hamstring surgical lengthening (RHSL', 'Hamstring surgical lengthening (HSL', 'Primary Versus Repeat Hamstring Surgical Lengthening']","['reduction of knee flexion at initial contact', 'knee extension', 'APT', 'Gait Deviation Index', 'Anterior pelvic tilt (APT', 'Knee flexion at initial contact', 'Popliteal angle', 'Reduction of minimum knee flexion']","[{'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0333068', 'cui_str': 'Flexion deformity (morphologic abnormality)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C1096245', 'cui_str': 'Gait deviation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1629036', 'cui_str': 'Pelvic tilt'}, {'cui': 'C0442037', 'cui_str': 'Popliteal (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",229.0,0.0190029,"Reduction of minimum knee flexion in the stance phase (24.9 to 17.5 degrees, P<0.001) and improvement of the Gait Deviation Index (52.9 to 60.2, P<0.001) occurred only in group A. Anterior pelvic tilt (APT) increased in groups A (from 17 to 19.5 degrees, P<0.001) and B (from 14.9 to 19.4 degrees, P<0.001) after treatment.","[{'ForeName': 'Mauro C', 'Initials': 'MC', 'LastName': 'Morais Filho', 'Affiliation': 'Gait Laboratory and Cerebral Palsy Clinic.'}, {'ForeName': 'Francesco C', 'Initials': 'FC', 'LastName': 'Blumetti', 'Affiliation': 'Gait Laboratory and Cerebral Palsy Clinic.'}, {'ForeName': 'Cátia M', 'Initials': 'CM', 'LastName': 'Kawamura', 'Affiliation': 'Association for the Care of Disabled Children, São Paulo, Brazil.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Fujino', 'Affiliation': 'Gait Laboratory and Cerebral Palsy Clinic.'}, {'ForeName': 'Marcelo S', 'Initials': 'MS', 'LastName': 'Matias', 'Affiliation': 'Association for the Care of Disabled Children, São Paulo, Brazil.'}, {'ForeName': 'José A F', 'Initials': 'JAF', 'LastName': 'Lopes', 'Affiliation': 'Association for the Care of Disabled Children, São Paulo, Brazil.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001464']
275,32204234,The effect of culture-based education in improving knowledge of hypertension patients in Makassarese community in Indonesia.,"OBJECTIVE


This research aimed to determine the effect of culture-based education in improving knowledge of hypertension patients in the Makassarese Community, Indonesia.
METHOD


This study used a quasi-experiment with two groups pretest-posttest control group design. The sample was 36 respondents, which were divided into two groups, which were given culture-based education and control group is given ordinary education. Each group was given a pretest and posttest.
RESULT


This study shows that there was an increasing knowledge of the intervention group after receiving cultural-based education. The research results showed t-value 1.92 with significant p-value >0.005 with the mean values in the intervention group 27.78 and 11.67 in the control group.
CONCLUSION


Education of culture-based hypertension affects increasing knowledge of people with hypertension in the community. Therefore, it is expected that culture-based education can be used as a health education program to increase the knowledge of hypertension patients effectively.",2020,"The research results showed t-value 1.92 with significant p-value >0.005 with the mean values in the intervention group 27.78 and 11.67 in the control group.
","['hypertension patients in Makassarese community in Indonesia', 'hypertension patients in the Makassarese Community, Indonesia']","['culture-based education and control group is given ordinary education', 'culture-based education']",[],"[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],,0.0152891,"The research results showed t-value 1.92 with significant p-value >0.005 with the mean values in the intervention group 27.78 and 11.67 in the control group.
","[{'ForeName': 'Andi Pramesti', 'Initials': 'AP', 'LastName': 'Ningsih', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia.'}, {'ForeName': 'Nurhaya', 'Initials': 'N', 'LastName': 'Nurdin', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia. Electronic address: nurhayanurdin@yahoo.com.'}, {'ForeName': 'Arnis', 'Initials': 'A', 'LastName': 'Puspitha', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Malasari', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia.'}, {'ForeName': 'Kusrini', 'Initials': 'K', 'LastName': 'Kadar', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.09.003']
276,32204240,Potential combination of back massage therapy and acupressure as complementary therapy in postpartum women for the increase in the hormone oxytocin.,"OBJECTIVE


This study was designed to determine the effect of back massage, acupressure, and a combination of a back massage and acupressure to the levels of the hormone oxytocin and uterine involution of postpartum primipara mothers.
METHOD


It was a quasi-experimental design with a pretest-posttest control group design that is observations made before and after treatment of the subject. Subjects consisted of 45 primipara postpartum mothers divided into three groups, each group consisting of 15 mothers. The interventions carried out were back massage, acupressure, and a combination of back massage. All interventions were carried out once a day for three days daily with a duration of 30min every morning at 09.00-09.15. Massage is carried out along the vertebrae until the 5th and 6th costal bone; then acupressure is performed at the LU point 1-rib 2, point CV 17, and point SI 1.
RESULTS


All groups given complementary therapy showed a significant increase in the oxytocin hormone. However, the highest increase was in the combination of back massage and acupressure.
CONCLUSION


The combination of back massage and acupressure therapy is worth considering as a complementary therapy for postpartum primiparous women in helping to increase the hormone oxytocin.",2020,All groups given complementary therapy showed a significant increase in the oxytocin hormone.,"['postpartum primipara mothers', 'Subjects consisted of 45 primipara postpartum mothers divided into three groups, each group consisting of 15 mothers', 'postpartum primiparous women', 'postpartum women']","['back massage, acupressure, and a combination of a back massage and acupressure', 'back massage and acupressure therapy', 'back massage therapy and acupressure', 'back massage, acupressure, and a combination of back massage']",['oxytocin hormone'],"[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3536731', 'cui_str': 'Massage Therapy'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",45.0,0.0243373,All groups given complementary therapy showed a significant increase in the oxytocin hormone.,"[{'ForeName': 'Fajar Dhini', 'Initials': 'FD', 'LastName': 'Yahya', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia. Electronic address: fajar@pasca.unhas.ac.id.'}, {'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'A Wardihan', 'Initials': 'AW', 'LastName': 'Sinrang', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Alasiry', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Burhanuddin', 'Initials': 'B', 'LastName': 'Bahar', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.163']
277,32204261,Ajwa date fruit (Phoenix dactylifera L.) in increasing hemoglobin (Hb) level to teenage girl.,"OBJECTIVE


This study aimed to analyze the impact on giving Ajwa date fruit (Phoenix dactylifera L.) in increasing a hemoglobin (Hb) level to a teenage girl.
METHODS


This study has used pre-experimental design, one group pretest, and posttest. The population was 119 teenage girls, and the sample was 35 persons chosen purposively. Samples were all female students around 15-18 years, Hb level >8g/dl to 12g/dl, and already menarche. The used instruments were Hb test filling sheet and food recall 24h. The result was examined by using Paired T-test.
RESULTS


Result of this research shows that the average of hemoglobin level before the intervention was 10.786g/dl, and the average of hemoglobin level after intervention is 11.143g/dl. There is an increase of Hb level (0.357g/dl) after the intervention.
CONCLUSION


Based on the result of this study, it can be concluded that there is an increase of Hb to teenage after the intervention of Ajwa the date fruit.",2020,"There is an increase of Hb level (0.357g/dl) after the intervention.
","['Samples were all female students around 15-18 years, Hb level ', 'The population was 119 teenage girls, and the sample was 35 persons chosen purposively']",[],"['hemoglobin', 'hemoglobin level', 'Hb level']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",119.0,0.0150807,"There is an increase of Hb level (0.357g/dl) after the intervention.
","[{'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Gemini', 'Initials': 'G', 'LastName': 'Alam', 'Affiliation': 'Department of Pharmacy, Pharmacy Faculty, Hasanuddin University, Indonesia. Electronic address: gemini@pasca.unhas.ac.id.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Samrichard', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.036']
278,31178259,Could Short-Term Perioperative High-Dose Atorvastatin Offer Antiarrhythmic and Cardio-Protective Effects in Rheumatic Valve Replacement Surgery?,"OBJECTIVES


To evaluate the role of prophylactic high-dose atorvastatin for prevention of postoperative atrial fibrillation (POAF), inflammatory response attenuation, and myocardial protection after valve replacement cardiac surgery.
DESIGN


Randomized controlled trial.
SETTING


Assiut University Hospitals.
PARTICIPANTS


Sixty-four adult patients undergoing cardiac valve replacement surgery.
INTERVENTIONS


The participants were equally divided into 2 groups. Group S received 80 mg of atorvastatin (oral tablets), 12 and 2 hours preoperatively, and on the 2nd, 3rd, 4th, and 5th postoperative days. Control group C received placebo at the same time periods.
MEASUREMENTS


The incidence of POAF, postoperative white blood cell count, serum C-reactive protein, interleukin 6, and troponin I.
MAIN RESULTS


Group S patients showed a lower incidence of POAF compared with the placebo group (p = 0.031). The white blood cell count showed significant reductions in group S compared with group C on the second, third, fourth, and fifth postoperative days. The C-reactive protein level showed significant reductions on the third, fourth, and fifth postoperative days in group S compared with group C (p = 0.001, 0.001, and 0.001, respectively). The serum level of interleukin 6 showed a significant reduction on the fifth postoperative day in group S compared with group C (p = 0.001). There was no significant difference between the 2 groups regarding the troponin I level and inotropic score.
CONCLUSION


Prophylactic use of high dose atorvastatin can decrease the incidence of POAF and attenuate the inflammatory process in adult patients undergoing isolated rheumatic cardiac valve replacement surgery.",2019,"The C-reactive protein level showed significant reductions on the third, fourth, and fifth postoperative days in group S compared with group C (p = 0.001, 0.001, and 0.001, respectively).","['Sixty-four adult patients undergoing cardiac valve replacement surgery', 'Assiut University Hospitals', 'adult patients undergoing isolated rheumatic cardiac valve replacement surgery']","['placebo', 'prophylactic high-dose atorvastatin', 'atorvastatin (oral tablets', 'Atorvastatin', 'atorvastatin']","['serum level of interleukin', 'incidence of POAF', 'incidence of POAF, postoperative white blood cell count, serum C-reactive protein, interleukin 6, and troponin I', 'POAF', 'white blood cell count', 'troponin I level and inotropic score', 'postoperative atrial fibrillation (POAF), inflammatory response attenuation, and myocardial protection']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",64.0,0.13695,"The C-reactive protein level showed significant reductions on the third, fourth, and fifth postoperative days in group S compared with group C (p = 0.001, 0.001, and 0.001, respectively).","[{'ForeName': 'Essam Abd', 'Initials': 'EA', 'LastName': 'Allah', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Emad Zarief', 'Initials': 'EZ', 'LastName': 'Kamel', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: emadzarief@yahoo.com.'}, {'ForeName': 'Hany M', 'Initials': 'HM', 'LastName': 'Osman', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sayed Kaoud', 'Initials': 'SK', 'LastName': 'Abd-Elshafy', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Nabil', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Tarek Taha Hanafy', 'Initials': 'TTH', 'LastName': 'Elmelegy', 'Affiliation': 'Clinical pathology department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Elkhayat', 'Affiliation': 'Cardiothoracic Surgery department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelrady Shehata', 'Initials': 'AS', 'LastName': 'Ibrahim', 'Affiliation': 'Anesthesia and ICU department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed Al', 'Initials': 'AA', 'LastName': 'Minshawy', 'Affiliation': 'Cardiothoracic Surgery department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.05.013']
279,32122951,A digital media attention diversion improves mood and fear in patients receiving chemotherapy for recurrent gynecologic malignancies: results of a randomized trial.,"BACKGROUND


Recurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status.
OBJECTIVES


To determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers.
STUDY DESIGN


This randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements.
RESULTS


The target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types.
CONCLUSIONS


Offering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.",2020,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"['Recurrent gynecologic cancer patients experience symptoms', 'patients receiving chemotherapy', 'patients with recurrent gynecologic cancers', 'enrolled women with recurrent gynecologic cancers', 'patients receiving chemotherapy for recurrent gynecologic malignancies']","['chemotherapy', 'digital media attention diversion', 'humorous digital media attention diversion', 'Chemotherapy', 'digital media device while receiving chemotherapy']","['change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains', 'Negative mood', 'mood and fear', 'negative mood and fear', 'Poor mood, pain, and fatigue']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0441354,Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001).,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA rjspencer2@wisc.edu.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Alexander', 'Affiliation': 'Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eickhoff', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Woo', 'Affiliation': 'Biostatistics and Medical Informatics, University of Wisconsin Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Costanzo', 'Affiliation': 'Psychiatry, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Communications Studies, Colorado State University, Fort Collins, Colorado, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Gynecologic Oncology, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001185']
280,31767947,Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.,"STUDY DESIGN


Clinical trial.
OBJECTIVE


Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo).
SETTING


Community.
METHOD


Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability.
RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 10 5  ± 0.9 × 10 5  mmHg • beat) than placebo (4.4 × 10 5  ± 0.6 × 10 5  mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use.
CONCLUSIONS


At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.",2020,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","['Participants (n\u2009=\u200913; age 44.0\u2009±\u20093.3\xa0years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring', 'during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia', 'Community']","['lidocaine', 'standard lubricant (placebo', 'placebo', 'lidocaine lubricant', 'lidocaine lubricant (Xylocaine 2%) ameliorates AD', 'Lidocaine lubricant']","['autonomic function', 'Overall, SAP', 'maximum SAP', 'Heart rate and rhythm disturbances', 'Bowel care duration', 'low-frequency systolic arterial pressure (LF SAP) variability']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0238015', 'cui_str': 'Spinal Autonomic Dysreflexia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.186011,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","[{'ForeName': 'Vera-Ellen M', 'Initials': 'VM', 'LastName': 'Lucci', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Inskip', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Shirromi', 'Initials': 'S', 'LastName': 'Sarveswaran', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Willms', 'Affiliation': 'International Collaboration on Repair and Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Claydon', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada. victoria_claydon@sfu.ca.'}]",Spinal cord,['10.1038/s41393-019-0381-2']
281,32099975,Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children?,"PURPOSE


This randomised controlled study evaluated the effectiveness of an oral probiotic, Streptococcus salivarius M18 (SsM18), in children with black stains (BSs) in order to counteract their reformation.
MATERIALS AND METHODS


Fifty-eight children (aged 4-10 years) presenting with BSs were enrolled. They were randomly divided into two groups: group A (n = 29) included children who were given the test product containing SsM18 once a day for 3 months; group B (n = 29) included children who did not receive any treatment. Before beginning the study, all the children underwent professional removal of BSs. The assessment of BSs was done after 3 months (T1) and after 6 months (T2).
RESULTS


Four patients (1 belonging to group A and 3 to group B) were excluded from the study because they started antibiotic therapy. After 3 months (T1), BSs were detected in 6 of the 28 children (21.2%) from group A and in 13 out of the 26 (50%) children from group B (p < 0.05). After 6 months (T2), BSs were detected in 9 out of the 28 (32.1%) children from group A and in 14 of the 26 (53.8%) children from group B (p > 0.05).
CONCLUSIONS


BSs formation in children could be prevented by administering S. salivarius M18.",2020,"After 3 months (T1), BSs were detected in 6 of the 28 children (21.2%) from group A and in 13 out of the 26 (50%) children from group B (p < 0.05).","['Fifty-eight children (aged 4-10 years) presenting with BSs were enrolled', 'children with black stains (BSs']","['oral probiotic, Streptococcus salivarius M18 (SsM18']",[],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}]",[],58.0,0.0282404,"After 3 months (T1), BSs were detected in 6 of the 28 children (21.2%) from group A and in 13 out of the 26 (50%) children from group B (p < 0.05).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Gobbi', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferri', 'Affiliation': ''}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43359']
282,32238987,Effect of Air-Particle-Abrasion Protocols on Surface Roughness and Early Biofilm Formation of Zirconia.,"PURPOSE


The air-particle-abrasion on zirconia in the gingival area of connectors and pontics in fixed partial dentures appears to increase fracture resistance. This study evaluated 'in situ' biofilm formation on the zirconia surface after different air-particle-abrasion protocols.
MATERIALS AND METHODS


Ninety sintered blocks (5 × 5 × 2 mm) of yttrium partially stabilised zirconia (Y-TZP) were obtained and randomised among nine groups according to the factors 'type of particle' (Alumina 50 and 110 µm; Cojet and Rocatec) and 'pressure' (2.5 and 3.5 bar) used for sandblasting for 10 s. The surface roughness (Ra/Rz) was measured before and after sandblasting. For the in-situ analyses, custom-made removable intraoral devices n = 10 with one sample of each group attached to the buccal area were used by volunteers for 8 h at night. The specimens were analysed under confocal microscopy to quantify both biovolume and thickness of the initial biofilm formed. One-way analysis of variance (ANOVA) and Dunnett's tests were performed (5%).
RESULTS


The roughness values ranged from 0.05 to 0.39 µm for Ra and from 0.35 to 2.11 µm for Rz, p = 0.00. Mean biofilm thickness ranged from 0.06 and 0.54 µm (p = 0.005), while the biovolume values were between 0.02 and 0.61 µm3/µm2 (p = 0.002). Values statistically significant for biofilm thickness and biovolume were found in groups sandblasted with Rocatec using 3.5 bar.
CONCLUSION


In order to increase the fracture resistance of zirconia fixed partial dentures (FPDs), the air particle abrasion of zirconia with SiO2 (110 μm/3.5 bar), in the gingival area of connectors and pontics, should be avoided.",2020,"Values statistically significant for biofilm thickness and biovolume were found in groups sandblasted with Rocatec using 3.5 bar.
","[""Ninety sintered blocks (5 × 5 × 2 mm) of yttrium partially stabilised zirconia (Y-TZP) were obtained and randomised among nine groups according to the factors 'type of particle' (Alumina 50 and 110 µm; Cojet and Rocatec) and 'pressure' (2.5 and 3.5 bar) used for sandblasting for 10 s""]",['Air-Particle-Abrasion Protocols'],"['Mean biofilm thickness', 'biofilm thickness and biovolume', 'roughness values', 'surface roughness (Ra/Rz', 'biovolume values', 'Surface Roughness and Early Biofilm Formation of Zirconia', 'fracture resistance']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0172527', 'cui_str': 'Rocatec'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.017508,"Values statistically significant for biofilm thickness and biovolume were found in groups sandblasted with Rocatec using 3.5 bar.
","[{'ForeName': 'Vanessa Cruz', 'Initials': 'VC', 'LastName': 'Macedo', 'Affiliation': ''}, {'ForeName': 'Priscilla Cristoforides', 'Initials': 'PC', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'José Renato Cavalvanti de', 'Initials': 'JRC', 'LastName': 'Queiroz', 'Affiliation': ''}, {'ForeName': 'Amanda Maria de Oliveira', 'Initials': 'AMO', 'LastName': 'Dal Piva', 'Affiliation': ''}, {'ForeName': 'Dayanne Monielle Duarte', 'Initials': 'DMD', 'LastName': 'Moura', 'Affiliation': ''}, {'ForeName': 'Rubens Nisie', 'Initials': 'RN', 'LastName': 'Tango', 'Affiliation': ''}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': ''}, {'ForeName': 'Rodrigo Othávio de Assunção', 'Initials': 'ROA', 'LastName': 'Souza', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44321']
283,32204222,The effect of pravastatin on endothelin-1 levels and pregnancy outcomes in women who have a high risk for preeclampsia: A randomized control trial.,"OBJECTIVE


This study aimed to evaluate the effect of aspirin and pravastatin compared with aspirin on endothelin-1 levels, and the pregnancy outcome in pregnant women high risk for preeclampsia.
METHODS


It was a randomized clinical trial (RCT) analysis with block permutation. The sample divided into two groups. Group A as control has given aspirin 80mg and group B as an intervention group given aspirin 80mg plus pravastatin 20mg twice daily until 35 weeks gestation. Level of Endothelin-1 examined before and after treatment.
RESULTS


There no differences found in endothelin-1 levels before and after being treated with aspirin or aspirin and pravastatin, as well as in the umbilical artery resistance index, fetal biometry, and the development of the fetus in two groups was typical at 28-32 weeks' gestation. Similarly, no differences found in fetal outcomes such as preterm birth, fetal growth retardation, and the incidence of preeclampsia between the two groups.
CONCLUSION


As a conclusion, the administration of pravastatin, together with aspirin is no more effective than aspirin in preventing preeclampsia, to pregnancy outcome and decreasing endothelin-1 levels. No congenital abnormalities reported.",2020,"There no differences found in endothelin-1 levels before and after being treated with aspirin or aspirin and pravastatin, as well as in the umbilical artery resistance index, fetal biometry, and the development of the fetus in two groups was typical at 28-32 weeks' gestation.","['pregnant women high risk for preeclampsia', 'women who have a high risk for preeclampsia']","['aspirin and pravastatin', 'aspirin', 'aspirin or aspirin and pravastatin', 'pravastatin', 'aspirin 80mg plus pravastatin']","['endothelin-1 levels', 'endothelin-1 levels and pregnancy outcomes', 'Level of Endothelin-1', 'umbilical artery resistance index, fetal biometry, and the development of the fetus', 'fetal outcomes such as preterm birth, fetal growth retardation, and the incidence of preeclampsia']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}]",,0.108928,"There no differences found in endothelin-1 levels before and after being treated with aspirin or aspirin and pravastatin, as well as in the umbilical artery resistance index, fetal biometry, and the development of the fetus in two groups was typical at 28-32 weeks' gestation.","[{'ForeName': 'Deviana Soraya', 'Initials': 'DS', 'LastName': 'Riu', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Hasanuddin University, Indonesia. Electronic address: virayariu@gmail.com.'}, {'ForeName': 'Isharyah', 'Initials': 'I', 'LastName': 'Sunarno', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Efendi', 'Initials': 'E', 'LastName': 'Lukas', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Wewengkang', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Rizki', 'Initials': 'R', 'LastName': 'Amalia', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.147']
284,32281095,Investigation of a New Catheter on Relieving Pain During Male Cystoscopy - A Randomized Clinical Trial.,"PURPOSE


To investigate the pain intensity and tolerability of a new catheter applied to urethral surface anesthesia during rigid cystoscopy in male patients, and explore the prospects of its application and the anesthetic method in hospitals at primary levels.
MATERIALS AND METHODS


252 adult male patients were randomly divided into the experimental group and the control group.1% lidocaine solution was irrigated into the posterior urethra of the experimental group using the new catheter before cystoscopy, while the control group was administered with lidocaine gel. Both groups were assessed by visual analogue scale(VAS) with their pain perceived during administration of lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group) (T1),during the insertion of cystoscope (T2),at the beginning of cystoscopy (T3),The third minute of cystoscopy (T4), during the first urination after the procedure (T5), as well with the maximum pain(Pmax) perceived during the whole procedure. The fluctuations of blood pressure and heart rate in each group before, after and during the procedure were recorded, and the anesthesia costs in both groups were calculated.
RESULTS


Except a slightly higher score in T1, the scores of VAS in experimental group were lower than those of control group in T2,T3 and T4. The Pmax of the control group was 4.92(SD=1.20), which was higher than in the experimental group of 3.89(SD=0.95,P<0.01).There was no significant difference on blood pressure variation in both groups. While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups. The anesthesia cost of the experimental group is about 1.53 dollars, with 1.75 dollars lower than that of the control group.
CONCLUSION


It is tolerable and beneficial to apply the new catheter for male urethral anesthesia. It can significantly relieve the pain during rigid cystoscopy in male patients, and is low in cost and easy in operation. Thus this method is worth being recommended to hospitals, especially at community hospitals or primary hospitals.",2020,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","['252 adult male patients', 'male urethral anesthesia', 'male patients']","['New Catheter', 'control group.1% lidocaine solution', 'lidocaine gel', 'new catheter applied to urethral surface anesthesia during rigid cystoscopy', 'lidocaine (control group) /during insertion of catheter and administration of lidocaine (experimental group']","['scores of VAS', 'heart rate variation', 'anesthesia costs', 'pain intensity and tolerability', 'pain', 'anesthesia cost', 'fluctuations of blood pressure and heart rate', 'blood pressure variation', 'Relieving Pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",252.0,0.0267797,"While heart rate variation in experimental group was lower than that in control group (16.3%,SD=3.4 vs. 22.6%,SD=5.0, P<0.01).No obvious complications were found in both groups.","[{'ForeName': 'Xiong Yong', 'Initials': 'XY', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China. xiongyongjiang1988@126.com.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Jiaji', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Urology,YongChuan Hospital of ChongQing medical university,Xuan Hua Road,Yongchuan District, ChongQing,402160,China.'}]",Urology journal,['10.22037/uj.v0i0.5130']
285,31815260,"Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose-response trial.","Anti-tuberculosis (TB) drugs can induce a series of gastrointestinal adverse events, which can seriously affect patients' quality of life and may lead to treatment failure. Studies have shown that probiotics treatments can improve antibiotic-induced gastrointestinal symptoms. In this randomized, open-label, dose-response clinical trial, we investigated the preventive effects of Lactobacillus casei on anti-TB-induced gastrointestinal adverse events. In total, 429 adult patients who underwent intensive-phase anti-TB therapy were included and randomly assigned to consume one bottle of L. casei of per day (low-dose group, n = 142), two bottles of L. casei per day (high-dose group, n = 143), or no intervention (control group, n = 144) for 2 months. Each bottle of L. casei contained 10 billion colony-forming units of live L. casei. Patients' daily gastrointestinal symptoms were recorded during the intervention period. After 2 months of L. casei consumption, 397 patients had completed the intervention. Both the high and low dose L. casei groups (37.6% and 29.4%, respectively) had lower incidences of anti-TB-associated total gastrointestinal adverse events than the control group (50.0%). The high and low dose L. casei groups (3.5 d and 5.8 d, respectively) also had shorter duration anti-TB-associated adverse gastrointestinal symptoms than the control group (6.2 d). Regarding individual symptoms, the higher L. casei dose resulted in a lower incidence of vomiting and appetite loss. Similar dose-dependent protective effects of L. casei were observed regarding the duration of vomiting and appetite loss. These findings indicated that daily L. casei consumption prevented anti-TB-associated gastrointestinal adverse events. This trial was registered at the Chinese Clinical Trial Register (ChiCTR-IOR-17013210).",2020,Similar dose-dependent protective effects of L. casei were observed regarding the duration of vomiting and appetite loss.,"['adult patients', '397 patients had completed the intervention', '429 adult patients who underwent intensive-phase anti-TB therapy']","['Lactobacillus casei', 'proprietary Lactobacillus casei']","['anti-TB-associated gastrointestinal adverse events', 'incidences of anti-TB-associated total gastrointestinal adverse events', 'daily gastrointestinal symptoms', 'shorter duration anti-TB-associated adverse gastrointestinal symptoms', 'duration of vomiting and appetite loss', 'gastrointestinal adverse reactions', 'vomiting and appetite loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",429.0,0.086009,Similar dose-dependent protective effects of L. casei were observed regarding the duration of vomiting and appetite loss.,"[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Shanliang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Hao', 'Affiliation': ''}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': ''}]",Food & function,['10.1039/c9fo01583c']
286,31796532,An exercise and nutrition intervention for ovarian cancer patients during and after first-line chemotherapy (BENITA study): a randomized controlled pilot trial.,"BACKGROUND


Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.
PRIMARY OBJECTIVES


To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy.
STUDY HYPOTHESIS


Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.
TRIAL DESIGN


A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care.
MAJOR INCLUSION/EXCLUSION CRITERIA


Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse.
PRIMARY ENDPOINTS


Recruitment rate, completion rate, side effects, and adherence.
SAMPLE SIZE


n=30 patients (15 per arm) will be recruited.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised.
TRIAL REGISTRATION NUMBER


The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).",2020,"HYPOTHESIS


Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.
","['n=30 patients (15 per arm) will be recruited', 'patients receiving first-line chemotherapy', 'women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery', 'Exclusion', 'ovarian cancer patients during and after first', 'patients with ovarian cancer', 'patients diagnosed with ovarian cancer during and after first-line chemotherapy', 'ovarian cancer patients', 'Eastern Cooperative Oncology Group (ECOG) status of 2 or worse']","['line chemotherapy', 'exercise and nutrition program', 'combined nutrition and exercise', 'Physical exercise and a cancer-specific nutrition intervention', 'exercise and nutrition intervention', 'combined nutrition and exercise intervention']","['survival and QoL', 'Recruitment rate, completion rate, side effects, and adherence', 'survival or quality of life (QoL', 'feasibility, safety, and acceptance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.156349,"HYPOTHESIS


Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.
","[{'ForeName': 'Tabea', 'Initials': 'T', 'LastName': 'Maurer', 'Affiliation': 'Cancer Epidemiology, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany j.chang-claude@uke.de ta.maurer@uke.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Grundherr', 'Affiliation': 'Department of Oncology, Hematology, BMT with Section Pneumology, Hubertus Wald Tumour Center, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Patra', 'Affiliation': 'Universitäres Kompetenzzentrum für Sport- und Bewegungsmedizin (Athleticum), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jaeger', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Becher', 'Affiliation': 'Institute for Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Birgit-Christiane', 'Initials': 'BC', 'LastName': 'Zyriax', 'Affiliation': 'Preventive Medicine and Nutrition, Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chang-Claude', 'Affiliation': 'Cancer Epidemiology, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany j.chang-claude@uke.de ta.maurer@uke.de.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000585']
287,31818537,Minimally invasive surfactant therapy versus intubation for surfactant administration in very low birth weight infants with respiratory distress syndrome.,"BACKGROUND


Minimally invasive surfactant therapy (MIST) is a new mode of surfactant administration without intubation to spontaneously breathing preterm infants with respiratory distress syndrome (RDS). The aims of this study were to assess the feasibility, efficacy and safety of using MIST to give surfactant for very low birth weight (VLBW) infants with RDS.
METHODS


In total, 53 VLBW infants who were born before 32 gestational weeks with spontaneous breathing, respiratory distress, and requiring surfactant therapy were divided into two groups. The infants in group A (n = 29) were intubated and received surfactant replacement therapy via endotracheal tube, followed by mechanical ventilation (MV). The infants in group B (n = 24) received tracheal instillation of surfactant via a semirigid vascular catheter during spontaneous breathing under nasal continuous positive airway pressure (nCPAP). After surfactant instillation, the infants in group B were still placed on nCPAP.
RESULTS


Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.",2020,"Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.","['53 VLBW infants who were born before 32 gestational weeks with spontaneous breathing, respiratory distress, and requiring surfactant therapy', 'VLBW infants with RDS requiring surfactant replacement therapy', 'very low birth weight (VLBW) infants with RDS', 'spontaneously breathing preterm infants with respiratory distress syndrome (RDS', 'very low birth weight infants with respiratory distress syndrome']","['surfactant replacement therapy via endotracheal tube, followed by mechanical ventilation (MV', 'MIST', 'Minimally invasive surfactant therapy', 'tracheal instillation of surfactant via a semirigid vascular catheter during spontaneous breathing under nasal continuous positive airway pressure (nCPAP', 'invasive surfactant therapy (MIST']","['death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA', 'feasibility, efficacy and safety']","[{'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C3661922', 'cui_str': 'Surfactant replacement therapy'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3661922', 'cui_str': 'Surfactant replacement therapy'}, {'cui': 'C0442465', 'cui_str': 'Via endotracheal tube'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0441134', 'cui_str': 'Vascular catheter'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0190671', 'cui_str': 'Ligation of patent ductus arteriosus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",53.0,0.0503231,"Our data showed that infants in group B (MIST group) had significantly lower rate (P < 0.05) of composite outcome of death or bronchopulmonary dysplasia (BPD), duration of intermittent positive airway pressure ventilation (IPPV) or MV, drug treatment of patent ductus arteriosus (PDA), and surgical ligation of PDA than group A.
CONCLUSION


MIST is feasible, safe and it may reduce the composite outcome of death or BPD for VLBW infants with RDS requiring surfactant replacement therapy.","[{'ForeName': 'Xing-An', 'Initials': 'XA', 'LastName': 'Wang', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Lih-Ju', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Changhua Christian Children's Hospital, Changhua City, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan.""}, {'ForeName': 'Shan-Ming', 'Initials': 'SM', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Pen-Hua', 'Initials': 'PH', 'LastName': 'Su', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan.'}, {'ForeName': 'Jia-Yuh', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Changhua Christian Children's Hospital, Changhua City, Taiwan; Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan. Electronic address: 182288@cch.org.tw.""}]",Pediatrics and neonatology,['10.1016/j.pedneo.2019.11.002']
288,30911920,Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).,"BACKGROUND


Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.
METHODS


Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector.
RESULTS


Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations.
CONCLUSIONS


The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage.
CLINICAL TRIAL


Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.",2020,Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection.,"['Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014', 'Early closure (8-13\xa0days) of a']","['temporary stoma was compared to late closure', 'temporary ileostomy after rectal resection']","['safety and efficacy', 'postoperative complications', 'mean cost per patient', 'Costs', 'health-related quality of life']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C2937270', 'cui_str': 'Creation of temporary ileostomy (procedure)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",55.0,0.21309,Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden. jennifer.park@vgregion.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Angenete', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bock', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'Adiela', 'Initials': 'A', 'LastName': 'Correa-Marinez', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Danielsen', 'Affiliation': 'Department of Gastroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Gehrman', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Haglind', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'Jens E', 'Initials': 'JE', 'LastName': 'Jansen', 'Affiliation': 'Department of Surgery, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Skullman', 'Affiliation': 'Department of Surgery, Skaraborgs Sjukhus, Skövde, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Wedin', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Scandinavian Surgical Outcomes Research Group, University of Gothenburg, Sahlgrenska University Hospital, Östra, Gothenburg, 416 85, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Centre for Perioperative Optimization, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}]",Surgical endoscopy,['10.1007/s00464-019-06732-y']
289,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
290,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
291,32169459,Aquatic Cycling Improves Knee Pain and Physical Functioning in Patients With Knee Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


To assess the efficacy of a 12-week aquatic cycling training program for improving knee pain and physical functioning in patients with knee osteoarthritis (OA).
DESIGN


Two-arm, single-blind, parallel-group randomized controlled trial.
SETTINGS


OA outpatient clinic of the Maastricht University Medical Center+.
PARTICIPANTS


Patients (N=111, 50-70y) with unilateral mild-to-moderate knee OA.
INTERVENTIONS


Participants (aquatic cycling [AC] group, n=55) received AC sessions of 45 min each 2 times per week. Each session combined upright seated cycling with out-of-saddle positions and exercises for the upper and lower body. The usual care (UC) group (n=47) continued with UC and was offered 12 AC sessions in a local swimming pool after their trial participation.
MAIN OUTCOME MEASURES


The Knee Injury and Osteoarthritis Outcome Score (KOOS) on knee pain and physical function was assessed at baseline, postintervention, and at 24-wk follow-up. Multilevel (mixed regression) analysis examined the effects.
RESULTS


Average attendance rate for the AC sessions was 80%. Statistically significant differences at postintervention and follow-up were found for knee pain in mean ± SD (UC pretest, 57.89±15.26; posttest, 55.90±18.04; follow-up, 57.24±19.16; and AC pretest, 56.96±12.96; posttest, 63.55±15.33; follow-up, 64.35±17.26; estimate, 8.16; SE, 3.27; 95% confidence interval [CI], 1.67-14.64; effect size [ES], 0.50) and physical functioning (UC pretest, 66.32±16.28; posttest, 66.80±19.04; follow-up, 65.42±17.98; and AC pretest, 61.89±17.151; posttest, 70.14±17.52; follow-up, 69.00±16.84; estimate, 7.16; SE, 3.19; 95% CI, 0.83-13.49; ES, 0.43) in favor of the aquatic group.
CONCLUSIONS


The results suggest that a 12-week AC training program improves self-reported knee pain and physical functioning in patients with mild-to-moderate knee OA compared to UC.",2020,The results suggest that a 12-week aquatic cycling training programme improves self-reported knee pain and physical functioning in patients with mild to moderate knee OA compared to usual care.,"['patients with mild to moderate knee OA', 'Patients (N=111, 50-70 years old) with unilateral mild to moderate knee OA', 'OA outpatient clinic of the Maastricht University Medical Center', 'patients with knee osteoarthritis']","['aquatic cycling training programme', 'Aquatic cycling', 'aquatic cycling training program', 'aquatic cycling sessions of 45 min twice-weekly', 'usual care group (UC, n=47) continued with usual care and was offered twelve aquatic cycling sessions']","['physical functioning', 'Average attendance rate', 'knee pain', 'knee pain and physical functioning', 'self-reported knee pain and physical functioning', 'Knee Injury and Osteoarthritis Outcome Score (KOOS) on knee pain and physical function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0525992,The results suggest that a 12-week aquatic cycling training programme improves self-reported knee pain and physical functioning in patients with mild to moderate knee OA compared to usual care.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Rewald', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'A F Ton', 'Initials': 'AFT', 'LastName': 'Lenssen', 'Affiliation': 'Department of Physiotherapy, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Emans', 'Affiliation': 'Department of Orthopedic Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': 'Department of Methodology & Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Mesters', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands. Electronic address: ilse.mesters@maastrichtuniversity.nl.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.023']
292,32145277,Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial.,"OBJECTIVE


To compare the effects of unilateral and bilateral arm training on arm impairment in severely affected patients with stroke.
DESIGN


Single-blinded, randomized controlled trial.
SETTING


Inpatient rehabilitation center.
PARTICIPANTS


First-time subacute patients (N=69) with stroke and a nonfunctional hand. Patients were stratified according to lesion location post hoc.
INTERVENTIONS


Repetitive bilateral arm training on an arm cycle followed by synchronized bilateral repetitive distal hand training or an identical unilateral arm training performed by the paretic limb only. Both unilateral and bilateral trainings were administered twice daily over 6 weeks.
MAIN OUTCOME MEASURES


The primary outcome measure was the Fugl-Meyer Assessment (FMA) score for the arm, and secondary measures were biomechanical parameters measuring isometric force and rate of force generation. Outcome measures were assessed before, at the end of, and 2 weeks after intervention.
RESULTS


Patients were homogeneous at study onset. All patients improved regarding the FMA arm score and most biomechanical parameters after intervention. Yet the post hoc analysis stratifying patients according to lesion location showed that patients with pure subcortical stroke, but not patients with cortical involvement of stroke, showed a significantly greater improvement (P=.022) following the bilateral training in FMA arm score (from 6.8±5.7 to 17.8±15.8) compared with unilateral training (from 6.5±7.8 to 8.7±8.6).
CONCLUSIONS


The benefit of bilateral arm training followed by repetitive bilateral hand training for motor control of the severely paretic upper limb may depend on lesion location. Further studies with larger sample size are required for the validation of these results.",2020,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"['severely affected stroke patients', 'Severely Affected Stroke Patients', 'Inpatient rehabilitation center', 'Sixty-nine first time subacute patients with stroke and a non-functional hand', 'Patients were homogeneous at study onset']","['Bilateral Arm Training versus unilateral Arm Training', 'Repetitive bilateral arm training on an ""arm-cycle"" followed by synchronized bilateral repetitive distal hand training, or an identical unilateral arm training performed by the paretic limb only', 'unilateral and bilateral arm training', 'repetitive bilateral hand training']","['Fugl-Meyer Score for the arm (FMA), and secondary measures were biomechanical parameters measuring isometric force and rate of force generation']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205300', 'cui_str': 'Non-functional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.160241,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"[{'ForeName': 'Caroline I E', 'Initials': 'CIE', 'LastName': 'Renner', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany. Electronic address: c.c.renner@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Brendel', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Hummelsheim', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.007']
293,32204253,The effect of acupressure therapy on the improvement of breast milk production in postpartum mothers.,"OBJECTIVE


Acupressure therapy is a traditional therapy from China where one of the treatments is used to increase milk production in postpartum mothers by doing massage at acupoints points CV17, ST18 and SI1 usually only using fingers or blunt objects that do not injure the body surface, which can provide a suppressing effect so that more acceptable and tolerated by patients.
METHOD


The research used was quasi-experiment with pre-post test control group design, which was conducted in the working area of health centre (puskesmas) Pasar wajo sub-district of Buton district with a sample of 70, consisting of 35 intervention groups and 35 control groups.
RESULTS


The group that was not given acupressure had a non-significant increase in breast milk production while them given acupressure had a significant increase.
CONCLUSION


Acupressure at the point of CV18, ST17, SI1 with a frequency of 3 times a week for three weeks can increase breastmilk production in postpartum mothers.",2020,"The group that was not given acupressure had a non-significant increase in breast milk production while them given acupressure had a significant increase.
","['Pasar wajo sub-district of Buton district with a sample of 70, consisting of 35 intervention groups and 35 control groups', 'postpartum mothers']","['Acupressure therapy', 'acupressure', 'acupressure therapy']","['breastmilk production', 'breast milk production', 'milk production']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033268'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",70.0,0.0224887,"The group that was not given acupressure had a non-significant increase in breast milk production while them given acupressure had a significant increase.
","[{'ForeName': 'Nurdewi', 'Initials': 'N', 'LastName': 'Sulymbona', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, South Sulawesi, Indonesia. Electronic address: nurdewisulymbona@pasca.unhas.ac.id.'}, {'ForeName': 'Suryani', 'Initials': 'S', 'LastName': ""As'ad"", 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Khuzaimah', 'Affiliation': 'Balai Kesehatan Tradisional Masyarakat, Indonesia.'}, {'ForeName': 'Upik Anderiani', 'Initials': 'UA', 'LastName': 'Miskad', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, South Sulawesi, Indonesia.'}, {'ForeName': 'Burhanudin', 'Initials': 'B', 'LastName': 'Bahar', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Makassar, South Sulawesi, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.002']
294,31944339,Is physical exercise and dietary therapy a feasible alternative to cognitive behavior therapy in treatment of eating disorders? A randomized controlled trial of two group therapies.,"OBJECTIVE


To compare effects of physical exercise and dietary therapy (PED-t) to cognitive behavioral therapy (CBT) in treatment of bulimia nervosa (BN) and binge-eating disorder (BED).
METHOD


The active sample (18-40 years of age) consisted of 76 women in the PED-t condition and 73 in the CBT condition. Participants who chose not to initiate treatment immediately (n = 23) were put on a waiting list. Outcome measures were the eating disorder examination questionnaire (EDE-Q), Clinical Impairment Assessment (CIA), Satisfaction with Life Scale (SWLS), Beck Depression Inventory (BDI), and numbers in remission at posttreatment, and at 6-, 12-, and 24-months follow-up.
RESULTS


Both treatment conditions produced medium to strong significant improvements on all outcomes with long-term effect. The PED-t produced a faster improvement in EDE-Q and CIA, but these differences vanished at follow-ups. Only PED-t provided improvements in BDI, still with no between-group difference. Totally, 30-50% of participants responded favorable to treatments, with no statistical between-group difference.
DISCUSSION


Both treatments shared a focus on normalizing eating patterns, correcting basic self-regulatory processes and reducing idealized aesthetic evaluations of self-worth. The results point to the PED-t as an alternative to CBT for BN and BED, although results are limited due to compliance and dropout rates. Replications are needed by independent research groups as well as in more clinical settings.",2020,"The PED-t produced a faster improvement in EDE-Q and CIA, but these differences vanished at follow-ups.","['Participants who chose not to initiate treatment immediately (n = 23) were put on a waiting list', 'The active sample (18-40\u2009years of age) consisted of 76 women in the PED-t condition and 73 in the CBT condition', 'bulimia nervosa (BN) and binge-eating disorder (BED']","['physical exercise and dietary therapy', 'cognitive behavior therapy', 'physical exercise and dietary therapy (PED-t) to cognitive behavioral therapy (CBT']","['EDE-Q and CIA', 'eating disorder examination questionnaire (EDE-Q), Clinical Impairment Assessment (CIA), Satisfaction with Life Scale (SWLS), Beck Depression Inventory (BDI), and numbers in remission at posttreatment, and at 6-, 12-, and 24-months follow-up', 'BDI']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C2960501', 'cui_str': 'Eating disorder examination questionnaire (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",76.0,0.0400426,"The PED-t produced a faster improvement in EDE-Q and CIA, but these differences vanished at follow-ups.","[{'ForeName': 'Therese Fostervold', 'Initials': 'TF', 'LastName': 'Mathisen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT-The Arctic University of Norway, Department of Psychology, Faculty of Health Sciences, Tromsø, Norway.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT-The Arctic University of Norway, Department of Psychology, Faculty of Health Sciences, Tromsø, Norway.'}, {'ForeName': 'KariAnne', 'Initials': 'K', 'LastName': 'Vrabel', 'Affiliation': 'Research Institute of Modum Bad, Vikersund, Norway.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'Department of Outdoor Studies, Sports and Physical Education, University College of Southeast Norway, Bø, Norway.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'Department of Health and Caring Sciences, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}]",The International journal of eating disorders,['10.1002/eat.23228']
295,32271690,Health Related Quality of Life of Patients with Bladder Cancer in the RAZOR Trial: A Multi-Institutional Randomized Trial Comparing Robot versus Open Radical Cystectomy.,"PURPOSE


We evaluated health related quality of life following robotic and open radical cystectomy as a treatment for bladder cancer.
MATERIALS AND METHODS


Using the Randomized Open versus Robotic Cystectomy (RAZOR) trial population we assessed health related quality of life by using the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index and the Short Form 8 Health Survey (SF-8) at baseline, 3 and 6 months postoperatively. The primary objective was to assess the impact of surgical approach on health related quality of life. As an exploratory analysis we assessed the impact of urinary diversion type on health related quality of life.
RESULTS


Analyses were performed in subsets of the per-protocol population of 302 patients. There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-Vanderbilt Cystectomy Index subscale or composite score (p >0.05). The emotional well-being score increased over time in both surgical arms. Patients in the open arm showed significantly better SF-8 sores in the physical and mental summary scores at 6 months compared to baseline (p <0.05). Continent diversion (versus noncontinent) was associated with worse FACT-bladder-cystectomy score at 3 (p <0.01) but not at 6 months, and the SF-8 physical component was better in continent-diversion patients at 6 months (p=0.019).
CONCLUSIONS


Our data suggests lack of significant differences in the health related quality of life in robotic and open cystectomies. As robotic procedures become more widespread it is important to discuss this finding during counseling.",2020,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,['Patients with Bladder Cancer'],"['Robot versus Open Radical Cystectomy', 'Robotic Cystectomy (RAZOR', 'robotic and open radical cystectomy']","['worse FACT-BL-cys score', 'SF-8 physical component', 'Continent diversion', 'SF-8 sores', 'FACT-VCI subscale or composite score', 'Health-Related Quality of Life', 'health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",302.0,0.140481,There was no statistically significant difference between the mean scores by surgical approach at any time point for any FACT-VCI subscale or composite score (p>0.05).,"[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Becerra', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Nachiketh', 'Initials': 'N', 'LastName': 'Soodana-Prakash', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Sanoj', 'Initials': 'S', 'LastName': 'Punnen', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Shyamal', 'Initials': 'S', 'LastName': 'Raolji', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Department of Urology, Division of Urologic Oncology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}]",The Journal of urology,['10.1097/JU.0000000000001029']
296,32088207,A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).,"Psoriasis, a chronic immune-mediated disease, is associated with an increased risk of cardiovascular events and mortality. Secukinumab selectively neutralizes IL-17A and has reported high efficacy with a favorable safety profile in various psoriatic disease manifestations. Subsequent to the 12-week randomized, placebo-controlled, double-blind treatment period, patients with moderate-to-severe psoriasis received secukinumab for 40 weeks. Vascular inflammation using  18 F-2-fluorodeoxyglucose-positron emission tomography/computed tomography imaging and blood-based cardiometabolic was assessed at week 0, 12, and 52. The difference in change in aortic inflammation from baseline to week 12 for secukinumab (n = 46) versus placebo (n = 45) was -0.053 (95% confidence interval = -0.169 to 0.064; P= 0.37). Small increases in total cholesterol, low-density lipoprotein, and low-density lipoprotein particles, but no changes in markers of inflammation, adiposity, insulin resistance, or predictors of diabetes, were observed with secukinumab treatment compared with placebo. At week 52, reductions in TNF-α (P= 0.0063) and ferritin (P= 0.0354), and an increase in fetuin-A (P= 0.0024), were observed with secukinumab treatment compared with baseline. No significant changes in aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance were observed with secukinumab treatment compared with baseline. Secukinumab exhibited a neutral impact on aortic vascular inflammation and biomarkers of cardiometabolic disease after 52 weeks of treatment.",2020,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","['Moderate to Severe Plaque Psoriasis (VIP-S', 'moderate-to-severe psoriasis patients received secukinumab for 40 weeks']","['placebo', 'Secukinumab', 'Placebo']","['Aortic Vascular Inflammation', 'aortic vascular inflammation and biomarkers of cardiometabolic disease', 'TNF-α', 'aortic inflammation', 'markers of inflammation, adiposity, insulin resistance, or predictors of diabetes', 'total cholesterol, LDL, and LDL particles', 'aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance', 'Vascular inflammation using FDG-PET/CT imaging and blood-based cardiometabolic']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0042395', 'cui_str': 'VIP'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.536985,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kristina Callis', 'Initials': 'KC', 'LastName': 'Duffin', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott &White, Dallas, Texas, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gottlieb', 'Affiliation': 'Dermatology and Skin Surgery Center, Exton, Pennsylvania, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Lockshin', 'Affiliation': 'DermAssociates, Rockville, Maryland, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'OSHU Dermatology Clinic, South Waterfront, Portland, Oregon, USA.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Kianifard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Rajendra Prasad', 'Initials': 'RP', 'LastName': 'Sarkar', 'Affiliation': 'Novartis Business Services, Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steadman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ahlman', 'Affiliation': 'Radiology and Imaging Sciences, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Aditya A', 'Initials': 'AA', 'LastName': 'Joshi', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Werner', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Abass', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.01.025']
297,31785505,Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia.,"PURPOSE


This study investigated the feasibility and efficacy of continuous noninvasive ventilation (NIV) support with 100% oxygen using a specially designed face mask, for reducing desaturation during fiberoptic bronchoscopy (FOB)-guided intubation in critically ill patients with respiratory failure.
MATERIALS AND METHODS


This was a single-center prospective randomized study. All patients undergoing FOB-guided nasal tracheal intubation were randomized to bag-valve-mask ventilation or NIV for preoxygenation followed by intubation. The NIV group were intubated through a sealed hole in a specially designed face mask during continuous NIV support with 100% oxygen. Control patients were intubated with removal of the mask and no ventilatory support.
RESULTS


We enrolled 106 patients, including 53 in each group. Pulse oxygen saturation (SpO 2 ) after preoxygenation (99% (96%-100%) vs. 96% (90%-99%), p = .001) and minimum SpO 2  during intubation (95% (87%-100%) vs. 83% (74%-91%), p < .01) were both significantly higher in the NIV compared with the control group. Severe hypoxemic events (SpO 2  < 80%) occurred less frequently in the NIV group than in controls (7.4% vs. 37.7%, respectively; p < .01).
CONCLUSIONS


Continuous NIV support during FOB-guided nasal intubation can prevent severe desaturation during intubation in critically ill patients with respiratory failure.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02462668. Registered on 25 May 2015, https://www.clinicaltrials.gov/ct2/results?term=NCT02462668.",2020,"Pulse oxygen saturation (SpO 2 ) after preoxygenation (99% (96%-100%) vs. 96% (90%-99%), p = .001) and minimum SpO 2  during intubation (95% (87%-100%) vs. 83% (74%-91%), p < .01) were both significantly higher in the NIV compared with the control group.","['critically ill patients with respiratory failure', 'All patients undergoing FOB-guided nasal tracheal intubation', 'We enrolled 106 patients, including 53 in each group']","['continuous noninvasive ventilation (NIV) support with 100% oxygen using a specially designed face mask', 'bag-valve-mask ventilation or NIV for preoxygenation followed by intubation', 'fiberoptic bronchoscopy-guided nasotracheal intubation', 'fiberoptic bronchoscopy (FOB)-guided intubation']","['minimum SpO 2  during intubation', 'Pulse oxygen saturation', 'Severe hypoxemic events', 'severe hypoxemia', 'severe desaturation']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0180823', 'cui_str': 'Face mask (physical object)'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation (procedure)'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",106.0,0.259163,"Pulse oxygen saturation (SpO 2 ) after preoxygenation (99% (96%-100%) vs. 96% (90%-99%), p = .001) and minimum SpO 2  during intubation (95% (87%-100%) vs. 83% (74%-91%), p < .01) were both significantly higher in the NIV compared with the control group.","[{'ForeName': 'Lingbo', 'Initials': 'L', 'LastName': 'Nong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yuheng', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weiqun', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, State Key Lab of Respiratory Diseases, National Clinical Research Center of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Journal of critical care,['10.1016/j.jcrc.2019.10.017']
298,30608308,Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project.,"Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries. This article describes the study design and methodological considerations of the Bringing Rehabilitation to American Veterans Everywhere (BRAVE) Project, a randomized controlled trial of CI therapy to improve the motor deficit of participants with chronic and subacute traumatic brain injury. Our CI therapy protocol comprises 4 major components: (1) intensive training of the more-affected UE for target of 3 hour/day for 10 consecutive weekdays, (2) a behavioral technique termed shaping during training, (3) a ""transfer package,"" 0.5 hour/day, of behavioral techniques to transfer therapeutic gains from the treatment setting to the life situation, and (4) prolonged restraint of use of the UE not being trained. The primary endpoint is posttreatment change on the Motor Activity Log, which assesses the use of the more-affected arm outside the laboratory in everyday life situations. Data from a number of secondary outcome measures are also being collected and can be categorized as physical, genomic, biologic, fitness, cognitive/behavioral, quality of life, and neuroimaging measures.",2019,Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries.,"['American Veterans Everywhere', 'individuals with upper extremity (UE) hemiparesis following different neurologic injuries', 'participants with chronic and subacute traumatic brain injury', 'Rehabilitation of Upper Extremity Motor Deficit']","['CI therapy', 'Constraint-induced movement therapy (CI therapy', 'CI Therapy']","['physical, genomic, biologic, fitness, cognitive/behavioral, quality of life, and neuroimaging measures', 'Motor Activity Log, which assesses the use of the more-affected arm outside the laboratory in everyday life situations']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0034380'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0425386,Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries.,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Morris', 'Affiliation': ""From the Departments of Psychology (Drs Taub, Mark, and Uswatte, Mss Bishop-McKay, Taylor, Reder, and Adams, and Mr Womble), Physical Therapy (Drs Morris and Uswatte), Physical Medicine and Rehabilitation (Dr Mark), Neurology (Drs Mark and Szaflarski), Occupational Therapy (Dr Rimmer), and UAB/Lakeshore Research Collaborative (Dr Rimmer and Mr Dew), University of Alabama at Birmingham; Edward Via College of Osteopathic Medicine, Auburn, Alabama (Dr Liu); National Intrepid Center of Excellence, Bethesda, Maryland (Dr Pickett); Departments of Psychiatry, Neurology, and Physical Medicine and Rehabilitation, University of Colorado and Denver Veteran's Medical Center, Denver (Dr Brenner); Rocky Mountain MIRECC, Denver, Colorado (Ms Stearns-Yoder); and Departments of Physical Medicine and Rehabilitation (Dr Stevens) and Psychology (Mr Rothman), Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Taub', 'Affiliation': ''}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Mark', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brenner', 'Affiliation': ''}, {'ForeName': 'Treven', 'Initials': 'T', 'LastName': 'Pickett', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Stearns-Yoder', 'Affiliation': ''}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Bishop-McKay', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Reder', 'Affiliation': ''}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': ''}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Dew', 'Affiliation': ''}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Szaflarski', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Womble', 'Affiliation': ''}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rothman', 'Affiliation': ''}, {'ForeName': 'Gitendra', 'Initials': 'G', 'LastName': 'Uswatte', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000460']
299,30971773,"Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase.","The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.",2019,"The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment.","['chronic subdural haematoma', '100 patients were recruited within nine months of commencement', '100 patients from United Kingdom Neurosurgical Units within 12 months', 'patients with a symptomatic chronic subdural haematoma']","['dexamethasone or placebo', 'placebo', 'dexamethasone']",['modified Rankin Scale'],"[{'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",100.0,0.618827,"The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Edlmann', 'Affiliation': 'Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. ee291@cam.ac.uk.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Thelin', 'Affiliation': 'Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Caldwell', 'Affiliation': ""Division of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': ""Division of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whitfield', 'Affiliation': 'Southwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Bulters', 'Affiliation': 'Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Holton', 'Affiliation': 'Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Suttner', 'Affiliation': 'Institute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Owusu-Agyemang', 'Affiliation': 'Institute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK.'}, {'ForeName': 'Yahia Z', 'Initials': 'YZ', 'LastName': 'Al-Tamimi', 'Affiliation': 'Department of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gatt', 'Affiliation': 'Department of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Richards', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gherle', 'Affiliation': 'Southwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Toman', 'Affiliation': 'Department of Neurosurgery, University Hospital Birmingham NHS Foundation Trust, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'Nandi', 'Affiliation': 'Department of Neurosurgery, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Kane', 'Affiliation': 'Department of Neurosurgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pantaleo', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Davis-Wilkie', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tarantino', 'Affiliation': ""Division of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.'}, {'ForeName': 'Hani J', 'Initials': 'HJ', 'LastName': 'Marcus', 'Affiliation': 'Department of Neurosurgery, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.'}, {'ForeName': 'Aswin', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Department of Neurosurgery, Barts Health NHS trust, Whitechapel Road, London, E1 1BB, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belli', 'Affiliation': 'NIHR Surgical Reconstruction and Microbiology Research Centre & University Hospitals Birmingham NHS Foundation Trust, School of Clinical and Experimental Medicine, University of Birmingham, Institute of Biomedical Research (West), Room WX 2.61, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gafoor', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawson', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Whitehead', 'Affiliation': ""Clinical Trials Pharmacy, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Department of Clinical Neurosciences, Western General Hospitals NHS Trust, Crewe Road, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilkinson', 'Affiliation': 'Cambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Angelos G', 'Initials': 'AG', 'LastName': 'Kolias', 'Affiliation': 'Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Peter J A', 'Initials': 'PJA', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Scientific reports,['10.1038/s41598-019-42087-z']
300,32254027,Safety and efficacy of tranexamic acid with epinephrine for prevention of blood loss following surgery for trochanteric femoral fractures.,"OBJECTIVE


This study aimed to determine whether the local administration of tranexamic acid (TXA) combined with diluted epinephrine (DEP) reduces blood loss and the need for transfusions compared with the administration of TXA alone following surgery for trochanteric femoral fractures.
METHODS


Hundred patients were enrolled in this study. In the target group (TXA/DEP group: n=50; 19 men and 31 women, mean age 72.5±11.1 years), the surgical sites were injected with 35 mL normal saline mixed with 3 g of TXA with 0.2 mg of DEP at a 1:200,000 dilution (TXA/DEP) immediately after musculoaponeurotic closure. In the control group (TXA group: n=50; 22 men and 28 women; mean age: 70.5±12.2 years), the surgical site was injected with 35 mL normal saline containing 3 g of TXA alone. The main outcome measures were postoperative hemoglobin (Hb) levels, hematocrit, drainage volume, and total blood loss (TBL); the secondary measures included transfusion requirements and perioperative complications.
RESULTS


The mean Hb levels among patients in theTXA/DEP group were significantly lower than among those in the TXA group, measured on postoperative day 1 at 101.0±14.1 g/L vs. 106.9±10.5 g/L and day 3 as 104.2±8.2 g/L vs. 108.5±9.1 g/L, respectively (p<0.05). Drainage volume from the surgical site and TBL measured on postoperative day 2 were also significantly reduced in the TXA/DEP group vs. the TXA group, measured at 71.4±26.0 mL vs. 82.5±24.6 mL and 343.6±148.0 mL vs. 419.6±165.4 mL, respectively (p<0.05). Furthermore, 11 patients (22%) from the TXA group and 15 (30%) from the TXA/DEP group received blood transfusions; the mean number of transfusion events (1.2±0.4 vs. 1.9±0.7) and the amount of blood transfused (1.7±0.5 Units vs. 2.9±1.0 Units) was also markedly reduced in the TXA/DEP group (p<0.05). Two cases in the TXA/DEP group and three in the TXA group were diagnosed with deep vein thrombosis, a difference that did not reach statistical significance (p>0.05).
CONCLUSION


Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications. Our study indicates that the local administration of TXA/DEP is safe and more effective than the administration of TXA alone in treating trochanteric femoral fractures.
LEVEL OF EVIDENCE


Level III, Therapeutic study.",2020,Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications.,"['n=50; 19 men and 31 women, mean age 72.5±11.1 years), the surgical sites', 'surgery for trochanteric femoral fractures', 'Hundred patients were enrolled in this study', 'group: n=50; 22 men and 28 women; mean age: 70.5±12.2 years']","['35 mL normal saline mixed with 3 g of TXA with 0.2 mg of DEP at a 1:200,000 dilution (TXA/DEP', 'control group (TXA', '35 mL normal saline containing 3 g of TXA alone', 'TXA/DEP', 'TXA', 'tranexamic acid (TXA) combined with diluted epinephrine (DEP', 'theTXA/DEP', 'TXA with DEP', 'tranexamic acid with epinephrine']","['postoperative hemoglobin (Hb) levels, hematocrit, drainage volume, and total blood loss (TBL); the secondary measures included transfusion requirements and perioperative complications', 'mean Hb levels', 'blood transfusions; the mean number of transfusion events', 'blood loss', 'amount of blood transfused', 'deep vein thrombosis', 'Drainage volume']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2363779', 'cui_str': 'Trochanteric femoral fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",0.0,0.0742255,Local administration of TXA with DEP reduced blood loss and limited the need for blood transfusions after surgery for trochanteric femoral fracture without increasing the risk of perioperative complications.,"[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Wenzhou Seventh Hospital, Wenzhou, China.'}, {'ForeName': 'Huachen', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Osteopathy, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.02.135']
301,31046885,Physical Activity Change in an RCT: Comparison of Measurement Methods.,"Objectives:  We aimed to quantify the agreement between self-report, standard cut-point accelerometer, and machine learning accelerometer estimates of physical activity (PA), and exam- ine how agreement changes over time among older adults in an intervention setting.  Methods:  Data were from a randomized weight loss trial that encouraged increased PA among 333 postmenopausal breast cancer survivors. PA was estimated using accelerometry and a validated questionnaire at baseline and 6-months. Accelerometer data were processed using standard cut-points and a validated machine learning algorithm. Agreement of PA at each time-point and change was assessed using mixed effects regression models and concordance correlation.  Results:  At baseline, self-report and machine learning provided similar PA estimates (mean dif- ference = 11.5 min/day) unlike self-report and standard cut-points (mean difference = 36.3 min/ day). Cut-point and machine learning methods assessed PA change over time more similarly than other comparisons. Specifically, the mean difference of PA change for the cut-point versus machine learning methods was 5.1 min/day for intervention group and 2.9 in controls, whereas it was ≥ 24.7 min/day for other comparisons.  Conclusions:  Intervention researchers are facing the issue of self-report measures introducing bias and accelerometer cut-points being insensi- tive. Machine learning approaches may bridge this gap.",2019,"At baseline, self-report and machine learning provided similar PA estimates (mean dif- ference = 11.5 min/day) unlike self-report and standard cut-points (mean difference = 36.3 min/ day).","['333 postmenopausal breast cancer survivors', 'older adults in an intervention setting']",['RCT'],"['Physical Activity Change', 'PA change']","[{'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",333.0,0.0586213,"At baseline, self-report and machine learning provided similar PA estimates (mean dif- ference = 11.5 min/day) unlike self-report and standard cut-points (mean difference = 36.3 min/ day).","[{'ForeName': 'Sandahl H', 'Initials': 'SH', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': ''}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': ''}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Suneeta V', 'Initials': 'SV', 'LastName': 'Godbole', 'Affiliation': ''}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Marinac', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': ''}]",American journal of health behavior,['10.5993/AJHB.43.3.9']
302,31086941,The Incidence of Postoperative Seizures Following Treatment of Postinfectious Hydrocephalus in Ugandan Infants: A Post Hoc Comparison of Endoscopic Treatment vs Shunt Placement in a Randomized Controlled Trial.,"BACKGROUND


There are currently no published data directly comparing postoperative seizure incidence following endoscopic third ventriculostomy (ETV), with/without choroid plexus cauterization (CPC), to that for ventriculoperitoneal shunt (VPS) placement.
OBJECTIVE


To compare postoperative epilepsy incidence for ETV/CPC and VPS in Ugandan infants treated for postinfectious hydrocephalus (PIH).
METHODS


We performed an exploratory post hoc analysis of a randomized trial comparing VPS and ETV/CPC in 100 infants (<6 mo old) presenting with PIH. Minimum follow-up was 2 yr. Variables associated with and the incidence of postoperative epilepsy were compared (intention-to-treat) using a bivariate analysis. Time to first seizure was compared using the Kaplan-Meier method, and the relative risk for the 2 treatments was determined using Mantel-Haenszel hazard ratios.
RESULTS


Seizure incidence was not related to age (P = .075), weight (P = .768), sex (P = .151), head circumference (P = .281), time from illness to hydrocephalus onset (P = .973), or hydrocephalus onset to treatment (P = .074). Irritability (P = .027) and vision deficit (P = .04) were preoperative symptoms associated with postoperative seizures. Ten (10%) patients died, and 20 (20%) developed seizures over the follow-up period. Overall seizure incidence was 9.4 per 100 person-years (9.4 and 9.5 for ETV/CPC and VPS, respectively; P = .483), with no significant difference in seizure risk between groups (hazard ratio, 1.02; 95% CI: 0.42, 2.45; P = .966). Mean time to seizure onset was 8.5 mo for ETV/CPC and 11.2 mo for VPS (P = .464). As-treated, per-protocol, and attributable-intervention analyses yielded similar results.
CONCLUSION


Postoperative seizure incidence following treatment of PIH was 20% within 2 yr, regardless of treatment modality.",2019,Irritability (P = .027) and vision deficit (P = .04) were preoperative symptoms associated with postoperative seizures.,"['Ugandan Infants', '100 infants (<6 mo old) presenting with PIH', 'Ugandan infants treated for postinfectious hydrocephalus (PIH']","['ventriculoperitoneal shunt (VPS) placement', 'ETV/CPC and VPS', 'endoscopic third ventriculostomy (ETV), with/without choroid plexus cauterization (CPC', 'Endoscopic Treatment vs Shunt Placement', 'VPS and ETV/CPC']","['incidence of postoperative epilepsy', 'time from illness to hydrocephalus onset', 'Overall seizure incidence', 'vision deficit', 'head circumference', 'seizures', 'Mean time to seizure onset', 'seizure risk', 'Irritability', 'Incidence of Postoperative Seizures', 'Postoperative seizure incidence', 'weight']","[{'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephaly'}]","[{'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0844212', 'cui_str': 'Endoscopic Third Ventriculostomy'}, {'cui': 'C0008524', 'cui_str': 'Plexus Choroideus'}, {'cui': 'C0007471', 'cui_str': 'Cauterization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephaly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",100.0,0.426383,Irritability (P = .027) and vision deficit (P = .04) were preoperative symptoms associated with postoperative seizures.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Punchak', 'Affiliation': 'Global Neurosurgery Initiative, Program in Global Surgery and Social Change, Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Mbabazi Kabachelor', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ogwal', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Nalule', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Nalwoga', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ssenyonga', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mugamba', 'Affiliation': ""CURE Children's Hospital, Mbale, Uganda.""}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rattani', 'Affiliation': 'Global Neurosurgery Initiative, Program in Global Surgery and Social Change, Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Dewan', 'Affiliation': 'Global Neurosurgery Initiative, Program in Global Surgery and Social Change, Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Abhaya V', 'Initials': 'AV', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Neurosurgery, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schiff', 'Affiliation': 'Center for Neural Engineering, Department of Engineering Science and Mechanics, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Warf', 'Affiliation': 'Global Neurosurgery Initiative, Program in Global Surgery and Social Change, Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.'}]",Neurosurgery,['10.1093/neuros/nyz122']
303,32179445,Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer.,"BACKGROUND


The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer.
METHODS


This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual.
FINDINGS


Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31-54%) in the intervention group versus 50/87 (57%; 95% CI: 46-68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3-225).
INTERPRETATION


Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care.
FUNDING


Federal Ministry of Education and Research (BMBF; grant no. 01GY1339).
CLINICAL TRIAL INFORMATION


NCT02321813.",2020,"QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months).","['Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n\xa0=\xa0110 per group', 'breast cancer patients', 'patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany', 'All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies', 'patients with colorectal cancer', '220 patients with colorectal cancer']","[""care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control""]","['QoL was measured (EORTC QLQ-C30, QLQ-CR29', 'proportion of patients with a need for QoL therapy']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",220.0,0.184633,"QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months).","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Klinkhammer-Schalke', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053 Regensburg, Germany. Electronic address: monika.klinkhammer-schalke@ur.de.'}, {'ForeName': 'Brunhilde', 'Initials': 'B', 'LastName': 'Steinger', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053 Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Center for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Fürst', 'Affiliation': 'Caritas-Hospital St. Josef, Department of Surgery, Landshuter Str. 65, 93053 Regensburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gumpp', 'Affiliation': 'Klinikum Neumarkt, Department of Surgery, Nürnberger Str. 12, 92318 Neumarkt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Obermaier', 'Affiliation': 'Klinikum St. Elisabeth Straubing, Department of Surgery, St.-Elisabeth-Straße 23, 94315 Straubing, Germany.'}, {'ForeName': 'Pompiliu', 'Initials': 'P', 'LastName': 'Piso', 'Affiliation': 'Hospital Barmherzige Brüder Regensburg, Department of Surgery, Prüfeninger Str. 86, 93049 Regensburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lindberg-Scharf', 'Affiliation': 'Tumor Center Regensburg, Institute of Quality Management and Health Services Research of the University of Regensburg, Am Biopark 9, 93053 Regensburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.025']
304,32171104,"Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial.","BACKGROUND


The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a single-arm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma.
METHODS


Treatment-naïve patients received three preoperative cycles of S-1 (80-120 mg/day on days 1-14) and oxaliplatin (130 mg/m 2  on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061.
RESULTS


Of 29 patients included, median age was 60 (range, 43-73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%-97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3%-92.0%) and a disease control rate of 96.6% (95% CI, 82.2%-99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2%-26.3%). Downstaging of overall TNM stage was observed in 16 (55.2%) patients. During neoadjuvant therapy, 10 (34.5%) patients had grade ≥III adverse events. No treatment-related death occurred. Surgery-related complications were observed in 12 of 28 (42.9%) patients.
CONCLUSION


SOXA followed by surgery in patients with locally advanced gastric adenocarcinoma showed favourable activity and manageable safety. A randomised controlled trial in locally advanced gastric or oesophagogastric junction adenocarcinoma is ongoing (ClinicalTrials.gov: NCT04208347).",2020,"The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%).","[' median age was 60 (range, 43-73) years; 20 (69.0%) were male', 'locally advanced gastric or oesophagogastric junction adenocarcinoma', 'patients with locally advanced gastric cancer', 'patients with locally advanced gastric adenocarcinoma', '29 patients included', 'Treatment-naïve patients']","['SOXA', 'apatinib plus neoadjuvant chemotherapy', 'S-1', 'neoadjuvant chemotherapy', 'S-1, oxaliplatin and apatinib (SOXA', 'oxaliplatin']","['Downstaging of overall TNM stage', 'efficacy and safety', 'grade ≥III adverse events', 'Surgery-related complications', 'objective response rate', 'disease control rate', 'favourable activity and manageable safety', 'pathologic response', 'pathologic response rate (pRR', 'pathologic complete response rate', 'margin-free resection rate']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0376538', 'cui_str': 'Swine Infertility and Respiratory Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",29.0,0.27732,"The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%).","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Runhua', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Birendra Kumar', 'Initials': 'BK', 'LastName': 'Sah', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Zhongyin', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Zhenglun', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Zhentian', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Maneesh Kumarsing', 'Initials': 'MK', 'LastName': 'Beeharry', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Zichen', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China. Electronic address: ym10299@163.com.'}, {'ForeName': 'Zhenggang', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China. Electronic address: zzg1954@hotmail.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China. Electronic address: leedoctor@sina.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.013']
305,31046879,The Attitudinal and Motivational Effects of Anti-waterpipe Messages.,"Objectives:  Waterpipe smoking can lead to negative health outcomes. In this study, we examined responses to anti-waterpipe smoking public service announcements (PSAs).  Methods:  In a pilot study, current waterpipe smokers (N = 20) and susceptible waterpipe never smokers (N = 25) were randomized to view either 3 anti-waterpipe PSAs, created by the  Truth  campaign, or 3 control videos. Participants answered questions pertaining to message acceptance at 3 time-points and perceived risk and motivation to quit or avoid waterpipe at 4 time-points.  Results:  Participants were recruited from the community (N = 45; M age  = 22.4 years). Whereas waterpipe smokers and never smokers who viewed the PSAs significantly increased in acceptance of (p < .05) and positive attitudes towards (p < .05) the messages with increased viewing of the mes- sages, waterpipe never smokers did so at a significantly higher rate (p < .05). Waterpipe never smokers who viewed the PSAs had increased perceived severity and susceptibility of health harms of waterpipe compared to the control (p s  < .05). We also found gender differences.  Conclusions:  The 3 tested PSAs from the  Truth  campaign show evidence of effectiveness against waterpipe use.",2019,"Whereas waterpipe smokers and never smokers who viewed the PSAs significantly increased in acceptance of (p < .05) and positive attitudes towards (p < .05) the messages with increased viewing of the mes- sages, waterpipe never smokers did so at a significantly higher rate (p < .05).","['Participants were recruited from the community (N = 45; M age  = 22.4 years', 'current waterpipe smokers (N = 20) and susceptible waterpipe never smokers (N = 25']",['Waterpipe smoking'],"['severity and susceptibility of health harms of waterpipe', 'risk and motivation to quit or avoid waterpipe at 4 time-points', 'positive attitudes']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}]","[{'cui': 'C4505138', 'cui_str': 'Water Pipe Smoking'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",25.0,0.0184148,"Whereas waterpipe smokers and never smokers who viewed the PSAs significantly increased in acceptance of (p < .05) and positive attitudes towards (p < .05) the messages with increased viewing of the mes- sages, waterpipe never smokers did so at a significantly higher rate (p < .05).","[{'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leshner', 'Affiliation': ''}, {'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': ''}, {'ForeName': 'Jennifer I', 'Initials': 'JI', 'LastName': 'Vidrine', 'Affiliation': ''}, {'ForeName': 'Summer G', 'Initials': 'SG', 'LastName': 'Frank-Pearce', 'Affiliation': ''}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Hale', 'Affiliation': ''}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'Wagener', 'Affiliation': ''}]",American journal of health behavior,['10.5993/AJHB.43.3.3']
306,31046880,The Effect of Family Diabetes Self-management Education on Self-care Behaviors of Marshallese Adults with Type 2 Diabetes.,"Objectives:  In this study, we assessed the effect of Family Diabetes Self-Management Educa- tion (DSME) intervention on changes in self-care behaviors among Marshallese adults with type 2 diabetes.  Methods:  Marshallese adults (N = 211) with type 2 diabetes were randomized to a Family DSME intervention or a Standard DSME intervention. We assessed changes in diabetes- related self-care behaviors from baseline to 12 months within and between study arms using descriptive statistics and mixed effects logistic regression models adjusted for demographic characteristics and use of diabetes medication.  Results:  Family DSME participants had increased engagement in glucose monitoring and doctor visits, whereas Standard DSME participants had increased engagement in glucose monitoring. Family DSME participants increased engagement in glucose monitoring more than Standard DSME participants.  Conclusions:  DSME can improve some diabetes related self-care behaviors. Future studies on diabetes management should consider developing and testing interventions that seek to improve long-term rates of engagement in self-care behaviors.",2019,"Family DSME participants had increased engagement in glucose monitoring and doctor visits, whereas Standard DSME participants had increased engagement in glucose monitoring.","['Marshallese Adults with Type 2 Diabetes', 'Marshallese adults with type 2 diabetes', 'Marshallese adults (N = 211) with type 2 diabetes']","['Family DSME intervention or a Standard DSME intervention', 'Family Diabetes Self-Management Educa- tion (DSME) intervention', 'DSME', 'Family Diabetes Self-management Education']","['self-care behaviors', 'engagement in glucose monitoring and doctor visits', 'Self-care Behaviors', 'engagement in glucose monitoring']","[{'cui': 'C1556098', 'cui_str': 'Marshallese (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",211.0,0.030092,"Family DSME participants had increased engagement in glucose monitoring and doctor visits, whereas Standard DSME participants had increased engagement in glucose monitoring.","[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Felix', 'Affiliation': ''}, {'ForeName': 'Marie-Rachelle', 'Initials': 'MR', 'LastName': 'Narcisse', 'Affiliation': ''}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'English', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Haggard-Duff', 'Affiliation': ''}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Purvis', 'Affiliation': ''}, {'ForeName': 'Pearl A', 'Initials': 'PA', 'LastName': 'McElfish', 'Affiliation': ''}]",American journal of health behavior,['10.5993/AJHB.43.3.4']
307,31046883,Increasing Participation in Daily Activities among US Adults with Arthritis.,"Objectives:  This home-use study assessed participants' perceptions regarding a variety of life-style measures after taking acetaminophen extended-relief caplets or placebo as instructed for 10 consecutive days to reduce mild-to-moderate pain of osteoarthritis. Methods: Participants maintained usual daily activities. Screening questionnaire responses assessed participants' daily pain level and pain management strategies. End-of-study questionnaire responses evaluated participants' behaviors, attitudes, and outlook related to impact of daily pain experience on lifestyle and daily activities.  Results:  The acetaminophen group had significantly higher rat- ings for ability to be active throughout the day, accomplishing daily activities, waking up moving like their old selves again, feeling in charge of their pain, and doing things they like to do longer. Likewise, they found it significantly easier to live with their condition and think about things other than their pain.  Conclusions:  Consistent with international guidelines, healthcare professionals can design an initial multimodal treatment plan to help patients achieve short- term goals (ie, reduced pain, more active lifestyle) and then modify that regimen (eg, alter dose of analgesic, duration of physical activity) in accordance with patients' responses to treatment, thus supporting long-term goals (eg, maintenance of independence and lifestyle) many patients hope to achieve.",2019,"End-of-study questionnaire responses evaluated participants' behaviors, attitudes, and outlook related to impact of daily pain experience on lifestyle and daily activities.  ","['US Adults with Arthritis', '10 consecutive days to reduce mild-to-moderate pain of osteoarthritis']","['acetaminophen', 'placebo']","[""Screening questionnaire responses assessed participants' daily pain level and pain management strategies""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",,0.100486,"End-of-study questionnaire responses evaluated participants' behaviors, attitudes, and outlook related to impact of daily pain experience on lifestyle and daily activities.  ","[{'ForeName': 'Stephan G', 'Initials': 'SG', 'LastName': 'Wiet', 'Affiliation': ''}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Bass', 'Affiliation': ''}]",American journal of health behavior,['10.5993/AJHB.43.3.7']
308,32179446,"Comparison of survival between primary debulking surgery and neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers in phase III randomised trial.","BACKGROUND


Regarding the comparison between primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT) for stage III/IV ovarian, tubal and peritoneal cancers, EORTC55971 and CHORUS studies demonstrated noninferiority of NACT. Previously, we reported reduced invasiveness of NACT in JCOG0602. This is a final analysis including the primary endpoint of overall survival (OS).
METHODS


Patients were randomised to PDS (PDS followed by 8x paclitaxel and carboplatin, i.e. TC regimen) or NACT (4x TC, interval debulking surgery [IDS], 4x TC). The primary endpoint was OS. The noninferiority hazard ratio (HR) margin for NACT compared with PDS was 1·161. The planned sample size was 300.
FINDINGS


Between 2006 and 2011, 301 patients were randomised, 149 to PDS and 152 to NACT. The median OS was 49·0 and 44·3 months in the PDS and NACT. HR for NACT was 1·052 [90·8% confidence interval (CI) 0·835-1·326], and one-sided noninferiority p-value was 0·24. Median progression-free survival was 15·1 and 16·4 months in the PDS and NACT (HR: 0·96 [95%CI 0·75-1·23]). In the PDS arm, 147/149 underwent PDS and 49/147 underwent IDS. In the NACT arm 130/152 underwent IDS. Complete resection was achieved in 12% (17/147) of PDS and 31% (45/147) of PDS ± IDS in the PDS arm and in 64% (83/130) of IDS in the NACT arm. Optimal surgery (residual tumour <1 cm) was achieved in 37% (55/147), 63% (92/147), and 82% (107/130 respectively. In the NACT, PS 2/3, serum albumin ≤2·5, CA125 > 2000 an institution with low study activity was advantageous, whereas clear/mucinous histology was disadvantageous for OS.
INTERPRETATION


The noninferiority of NACT was not confirmed. NACT may not always be a substitute for PDS. However, as our study had smaller numbers, the noninferiority of the previous studies cannot be denied.
FUNDING


Ministry of Health, Labour and Welfare, Japan and the National Cancer Center, Japan.
CLINICAL TRIAL INFORMATION


UMIN000000523.",2020,"HR for NACT was 1·052 [90·8% confidence interval (CI) 0·835-1·326], and one-sided noninferiority p-value was 0·24.","['0·96', 'Between 2006 and 2011', '2000', 'Patients', '301 patients were randomised, 149 to PDS and 152 to NACT']","['NACT (HR', 'primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT', 'primary debulking surgery and neoadjuvant chemotherapy', 'PDS (PDS followed by 8x paclitaxel and carboplatin, i.e. TC regimen) or NACT (4x TC', 'NACT', 'interval debulking surgery [IDS], 4x TC']","['Median progression-free survival', 'noninferiority hazard ratio (HR) margin', 'serum albumin ≤2·5, CA125\xa0', 'Complete resection', 'median OS', 'overall survival (OS', 'OS']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",301.0,0.235826,"HR for NACT was 1·052 [90·8% confidence interval (CI) 0·835-1·326], and one-sided noninferiority p-value was 0·24.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Onda', 'Affiliation': 'Department of Gynecology, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: takashi-tky@umin.ac.jp.'}, {'ForeName': 'Toyomi', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Gynecology Service, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kasamatsu', 'Affiliation': 'Department of Gynecologic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Gynecologic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Takehara', 'Affiliation': 'Department of Gynecologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Ushijima', 'Affiliation': 'Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gynecology and Obstetrics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Kawana', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Harushige', 'Initials': 'H', 'LastName': 'Yokota', 'Affiliation': 'Department of Gynecology, Saitama Cancer Center, Kita Adachi Gun, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takano', 'Affiliation': 'Department of Clinical Oncology, National Defense Medical College Hospital, Tokorozawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kanao', 'Affiliation': 'Department of Gynecological Oncology, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoh', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Department of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osakasayama, Japan.'}, {'ForeName': 'Kaichiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Kindai University, Sakai Hospital, Sakai, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Yaegashi', 'Affiliation': 'Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Toshiharu', 'Initials': 'T', 'LastName': 'Kamura', 'Affiliation': 'Medical Care Education Research Foundation, Yanagawa Hospital, Yanagawa, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Ibaraki Prefectural Central Hospital, Kasama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.020']
309,32179448,"Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy.","PURPOSE


We analysed the cohort of paediatric patients with metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated in the BERNIE protocol, i.e. open-label, multicentre, randomised phase II study evaluating the role of bevacizumab (BO20924/ITCC-006; ClinicalTrials.gov: NCT00643565).
METHODS


Eligible patients were randomised 1:1 to add or not add bevacizumab to nine courses of intensive multi-drug chemotherapy, followed by 12-month maintenance chemotherapy (plus surgery and radiotherapy). The primary end-point was event-free survival (EFS); secondary objectives were objective response rate (ORR) and overall survival (OS).
RESULTS


From 2008 and 2013, 49 NRSTS patients (out of 154 cases) were treated, 26 in the standard arm and 23 in the bevacizumab arm. ORR was seen in 10 out of 36 evaluable cases (27.7%), i.e. 4/18 standard arm cases and 6/18 bevacizumab arm cases. Two-year EFS was 27.3% (95% confidence interval [CI] 13.9-42.5) for all NRSTS patients, i.e. 34.9% (95% CI 14.6-56.2) for bevacizumab arm and 22.9% (95% CI 7.1-43.9) for standard arm (p-value = 0.19). Three-year OS (median follow-up 48.6 months) was 35.2%, with no differences in the two arms. Time to event and time to death were 16.3 and 17.2 months for bevacizumab arm and 2.1 and 7.6 months for standard arm, respectively. Patients not receiving any local treatment on primary disease had a worse outcome as compared to others. Treatment results were better for patients receiving surgical resection and worse for those who did not receive any specific treatment.
CONCLUSION


The addition of the anti-angiogenic agent to the standard chemotherapy did not show statistically significant improvement in survival in metastatic NRSTS.",2020,The addition of the anti-angiogenic agent to the standard chemotherapy did not show statistically significant improvement in survival in metastatic NRSTS.,"['metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS', 'Eligible patients', 'paediatric patients with metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS']","['bevacizumab', 'intensive multi-drug chemotherapy, followed by 12-month maintenance chemotherapy (plus surgery and radiotherapy']","['ORR', 'survival', 'Time to event and time to death', 'event-free survival (EFS); secondary objectives were objective response rate (ORR) and overall survival (OS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",49.0,0.201355,The addition of the anti-angiogenic agent to the standard chemotherapy did not show statistically significant improvement in survival in metastatic NRSTS.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy. Electronic address: andrea.ferrari@istitutotumori.mi.it.'}, {'ForeName': 'Johannes H M', 'Initials': 'JHM', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands; Department of Pediatric Oncology, Emma Children's Hospital-Academic Medical Center Amsterdam, the Netherlands.""}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Chisholm', 'Affiliation': ""Children and Young People's Unit, Royal Marsden Hospital, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Paediatric Oncology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego', 'Affiliation': ""Paediatric Oncology, Hospital Universitario Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Max M', 'Initials': 'MM', 'LastName': 'van Noesel', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'McHugh', 'Affiliation': 'Radiology Department, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Rick R', 'Initials': 'RR', 'LastName': 'van Rijn', 'Affiliation': 'Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Gaze', 'Affiliation': 'Department of Oncology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Bicêtre Hospital, Hôpitaux Universitaires Paris-Sud, Assistance Publique Hôpitaux de Paris, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': ""Department of Pediatric Oncology, Institut D'Hematologie et D'Oncologie Pédiatrique,/Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': ""Department of Pediatric Oncology, Institut D'Hematologie et D'Oncologie Pédiatrique,/Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave-Roussy, Cancer Campus, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Hematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Geoerger', 'Affiliation': 'Department of Pediatric and Adolescent Oncology, Gustave-Roussy, Cancer Campus, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Hubert N', 'Initials': 'HN', 'LastName': 'Caron', 'Affiliation': 'IPODD, Pharma Development Oncology, Hoffmann-La Roche, Switzerland.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Trials and Biostatistics Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.029']
310,32208351,Older versus younger adults with gastric cancer receiving perioperative treatment: Results from the CRITICS trial.,"AIM


To evaluate treatment-related toxicity, treatment compliance, surgical complications and event-free survival (EFS) in older (≥70 years) versus younger (<70 years) adults who underwent perioperative treatment for gastric cancer.
METHODS


In the CRITICS trial, 788 patients with resectable gastric cancer were randomised before start of any treatment and received preoperative chemotherapy (3 cycles of epirubicin, cisplatin or oxaliplatin and capecitabine), followed by surgery, followed by either postoperative chemotherapy or chemoradiotherapy (45Gy + cisplatin + capecitabine).
RESULTS


172 (22%) patients were older adults. During preoperative chemotherapy, 131 (77%) older adults versus 380 (62%) younger adults experienced severe toxicity (p < 0.001); older adults received significantly lower relative dose intensities (RDIs) for all chemotherapeutic drugs. Equal proportions of older versus younger adults underwent curative surgery: 137 (80%) versus 499 (81%), with comparable postoperative complications and postoperative mortality. Postoperative therapy after curative surgery started in 87 (64%) older adults versus 391 (78%) younger adults (p < 0.001). Incidence of severe toxicity during postoperative chemotherapy was 22 (54%) in older adults versus 113 (59%) in younger adults (p = 0.541); older adults received significantly lower RDIs for all chemotherapeutic drugs. Severe toxicity rates for postoperative chemoradiotherapy were 22 (48%) older adults versus 89 (45%) for younger adults (p = 0.703), with comparable chemotherapy RDIs and radiotherapy dose. Two-year EFS was 53% for older adults versus 51% for younger adults.
CONCLUSION


Perioperative treatment compliance, especially in the postoperative phase, was poorer in older adults compared with younger adults. As comparable proportions of patients underwent curative surgery, future studies should focus on neo-adjuvant treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00407186. EudraCT number: 2006-00413032.",2020,"Equal proportions of older versus younger adults underwent curative surgery: 137 (80%) versus 499 (81%), with comparable postoperative complications and postoperative mortality.","['788 patients with resectable gastric cancer', 'patients were older adults', 'Older versus younger adults with gastric cancer receiving perioperative treatment', 'older (≥70 years) versus younger (<70 years) adults who underwent perioperative treatment for gastric cancer', '172 (22']","['postoperative chemotherapy', 'preoperative chemotherapy (3 cycles of epirubicin, cisplatin or oxaliplatin\xa0and capecitabine), followed by surgery, followed by either postoperative chemotherapy or chemoradiotherapy (45Gy\xa0+\xa0cisplatin\xa0+\xa0capecitabine', 'postoperative chemoradiotherapy', 'curative surgery']","['Incidence of severe toxicity', 'severe toxicity', 'relative dose intensities (RDIs', 'Severe toxicity rates', 'postoperative complications and postoperative mortality', 'toxicity, treatment compliance, surgical complications and event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",788.0,0.13605,"Equal proportions of older versus younger adults underwent curative surgery: 137 (80%) versus 499 (81%), with comparable postoperative complications and postoperative mortality.","[{'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Slagter', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tudela', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Radiation Oncology, Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Romy M', 'Initials': 'RM', 'LastName': 'van Amelsfoort', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nicole C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, Amsterdam University Medical Centers, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Department of Oncology, Stockholm Söder Hospital, Stockholm, Sweden; Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nordsmark', 'Affiliation': 'Department of Medical Oncology, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biometrics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Maarten C C M', 'Initials': 'MCCM', 'LastName': 'Hulshof', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Department of Gastrointestinal Oncology/Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeffrey P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Edwin P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology/Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: Marcel.Verheij@radboudumc.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.008']
311,31584838,"Yoga Improves Balance and Low-Back Pain, but Not Anxiety, in People with Parkinson's Disease.","Individuals with Parkinson's disease (PD) experience postural instability, low-back pain (LBP), and anxiety. These symptoms increase the risk of falls and decrease quality of life. Research shows yoga improves balance and decreases LBP and anxiety in healthy adults, but its effects in PD are poorly understood. All participants were part of a larger intervention study. Participants received pretest and posttest evaluations, including the Balance Evaluation Systems Test (BESTest), Beck Anxiety Inventory (BAI), and Revised Oswestry Disability Index (ROSW). Total scores for each measure, as well as individual balance system section scores from the BESTest (biomechanical constraints, stability limits/verticality, transitions/anticipatory, reactive, sensory orientation, and stability in gait) were compared within groups pre- to posttest. Participants in the yoga group (n = 13) completed a twice-weekly 12-week yoga interve n t i o n , whereas controls (n = 13) continued their usual routines for 12 weeks. Both the yoga (Z = -3.20, p = 0.001) and control (Z = -2.10, p = 0.040) groups improved on the BESTest total score. The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality (Z = -2.3, p = 0.020), transitions/ anticipatory (Z = -2.50, p = 0.010), reactive (Z = -2.70, p = 0.008), and sensory orientation (Z = -2.30, p = 0.020). ROSW decreased in the yoga group only (Z = -2.10, p = 0.030). BAI did not change in either group. Yoga is a nonpharmacological intervention that can improve balance and LBP in people with PD. This study demonstrated that yoga is feasible for people with PD, and participants reported high levels of enjoyment and intent to practice yoga after the study.",2020,"The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality ( Z  = -2.3,  p  = 0.020), transitions/anticipatory ( Z  = -2.50,  p  = 0.010), reactive ( Z  = -2.70,  p  = 0.008), and sensory orientation ( Z  = -2.30,  p  = 0.020).","['people with PD', 'healthy adults', ""People with Parkinson's Disease"", ""Individuals with Parkinson's disease (PD) experience postural instability, low-back pain (LBP), and anxiety""]",[],"['ROSW', 'Balance and Low-Back Pain', 'individual balance system section scores from the BESTest (biomechanical constraints, stability limits/verticality, transitions/anticipatory, reactive, sensory orientation, and stability in gait', 'BAI', 'Total scores', 'LBP and anxiety', 'individual balance systems', 'stability limits/verticality', 'sensory orientation', 'balance and LBP', 'Balance Evaluation Systems Test (BESTest), Beck Anxiety Inventory (BAI), and Revised Oswestry Disability Index (ROSW', 'risk of falls and decrease quality of life']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034380'}]",,0.0287948,"The control group showed no changes in individual balance systems, whereas the yoga group improved in stability limits/verticality ( Z  = -2.3,  p  = 0.020), transitions/anticipatory ( Z  = -2.50,  p  = 0.010), reactive ( Z  = -2.70,  p  = 0.008), and sensory orientation ( Z  = -2.30,  p  = 0.020).","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Myers', 'Affiliation': 'Department of Neurology, Washington University School of Medicine; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Elinor C', 'Initials': 'EC', 'LastName': 'Harrison', 'Affiliation': 'Department of Neurology, Washington University School of Medicine; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Kerri S', 'Initials': 'KS', 'LastName': 'Rawson', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Horin', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Ellen N', 'Initials': 'EN', 'LastName': 'Sutter', 'Affiliation': 'Department of Rehabilitation Medicine, University of Minnesota, Minneapolis; formerly, Program in Physical Therapy, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'McNeely', 'Affiliation': 'Unfold Productions, LLC, St. Louis; formerly, Program in Physical Therapy, Washington University School of Medicine, and Department of Neurology, Washington University School of Medicine, St. Louis.'}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': 'Program in Physical Therapy; Department of Neurology; and Department of Neuroscience, Washington University School of Medicine, St. Louis.'}]",International journal of yoga therapy,['10.17761/2020-D-18-00028']
312,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
313,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
314,32267481,Comparison of Blood Pressure Variability Between Losartan and Amlodipine in Essential Hypertension (COMPAS-BPV).,"BACKGROUND


Antihypertensive therapy using renin-angiotensin system blockers and calcium channel blockers to target blood pressure variability (BPV) has not yet been established. We aimed to compare the ability of losartan and amlodipine to lower BPV and systolic blood pressure (SBP) in essential hypertensive patients.
METHODS


Patients were randomly assigned either losartan 50 mg or amlodipine 5 mg. Medications were uptitrated and hydrochlorothiazide was added according to protocol for 6 months. The primary endpoint was the office visit-to-visit SD of SBP. The secondary endpoints included average real variability (ARV), office SBP, and home SBP.
RESULTS


The losartan group (n = 71) and amlodipine group (n = 73) finished the scheduled visits between April 2013 and May 2017. The office visit-to-visit SD of SBP was comparable between the losartan and amlodipine groups (11.0 ± 4.2 vs. 10.5 ± 3.8, P = 0.468). The office visit-to-visit ARV of SBP was significantly elevated in the losartan group (10.6 ± 4.3 vs. 9.1 ± 3.4, P = 0.02). The absolute SBP decrement from baseline to 6 months was similar between groups, although the office mean SBP at 6 months was higher in the losartan group (132.3 ± 12.9 vs. 127.5 ± 9.0 mm Hg, P = 0.011). In home blood pressure analysis, evening day-to-day BPV indexes (SD and ARV) were significantly higher in the losartan group at 6 months.
CONCLUSIONS


The lowering effect of the office visit-to-visit SD of SBP was similar between losartan and amlodipine. However, the losartan group showed a higher office visit-to-visit ARV of SBP and evening day-to-day home BPV indexes. Therefore, amlodipine may be better to lower BPV in essential hypertensive patients.",2020,The lowering effect of the office visit-to-visit SD of SBP was similar between losartan and amlodipine.,"['Patients', 'essential hypertensive patients', 'group (n=73) finished the scheduled visits between April 2013 and May 2017']","['hydrochlorothiazide', 'losartan and amlodipine', 'losartan 50 mg or amlodipine', 'amlodipine', 'losartan', 'calcium channel blockers']","['office visit-to-visit ARV of SBP', 'average real variability (ARV), office SBP and home SBP', 'office visit-to-visit standard deviation (SD) of SBP', 'office visit-to-visit SD of SBP', 'office mean SBP', 'blood pressure variability', 'higher office visit-to-visit ARV of SBP', 'absolute SBP decrement', 'BPV and systolic BP (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C3652748', 'cui_str': 'losartan and amlodipine'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}]","[{'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0300826,The lowering effect of the office visit-to-visit SD of SBP was similar between losartan and amlodipine.,"[{'ForeName': 'Jun-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jung-Woo', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Youn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Sung-Gyun', 'Initials': 'SG', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Min-Soo', 'Initials': 'MS', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jang-Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Junghan', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Dong Ryeol', 'Initials': 'DR', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine, Kangwon National University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Kyung-Soon', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Byung-Su', 'Initials': 'BS', 'LastName': 'Yoo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea.'}]",American journal of hypertension,['10.1093/ajh/hpaa060']
315,30967589,Effects of animal-assisted therapy on social behaviour in patients with acquired brain injury: a randomised controlled trial.,"Animal-assisted therapy (AAT) is increasingly used to address impaired social competence in patients with acquired brain injury. However, the efficacy of AAT has not been tested in these patients. We used a randomised, controlled within subject trial to determine the effects of AAT on social competence in patients undergoing stationary neurorehabilitation. Participants received both AAT sessions and paralleled conventional therapy sessions. The patients' social behaviour was systematically coded on the basis of video recordings of therapy sessions. Moreover, mood, treatment motivation and satisfaction was measured during each therapy session. We analysed 222 AAT and 219 control sessions of 19 patients with linear mixed models. Patients showed a significantly higher amount of social behaviour during AAT. Furthermore, patients' positive emotions, verbal and non-verbal communication, mood, treatment motivation and satisfaction were increased in the presence of an animal. Neutral emotions were reduced but no effect was found regarding negative emotions. Our results show that AAT increases aspects of social competence and leads to higher emotional involvement of patients with acquired brain injury, reflected in higher social engagement, motivation and satisfaction during a therapeutic session.",2019,"Our results show that AAT increases aspects of social competence and leads to higher emotional involvement of patients with acquired brain injury, reflected in higher social engagement, motivation and satisfaction during a therapeutic session.","['patients with acquired brain injury', '19 patients with linear mixed models', 'patients undergoing stationary neurorehabilitation']","['Animal-assisted therapy (AAT', 'AAT', 'animal-assisted therapy', 'AAT sessions and paralleled conventional therapy sessions']","['social engagement, motivation and satisfaction', 'mood, treatment motivation and satisfaction', 'social behaviour', 'positive emotions, verbal and non-verbal communication, mood, treatment motivation and satisfaction', 'social competence', 'Neutral emotions', 'negative emotions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}]","[{'cui': 'C0150133', 'cui_str': 'Animal Facilitated Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",222.0,0.0238149,"Our results show that AAT increases aspects of social competence and leads to higher emotional involvement of patients with acquired brain injury, reflected in higher social engagement, motivation and satisfaction during a therapeutic session.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hediger', 'Affiliation': 'Department of Psychology, University of Basel, Basel, Switzerland. karin.hediger@unibas.ch.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thommen', 'Affiliation': 'Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Margret', 'Initials': 'M', 'LastName': 'Hund-Georgiadis', 'Affiliation': 'REHAB Basel, Clinic for neurorehabilitation and paraplegiology, Basel, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-42280-0']
316,32255549,"First-in-Human Studies of MW01-6-189WH, a Brain-Penetrant, Antineuroinflammatory Small-Molecule Drug Candidate: Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Studies in Healthy Adult Volunteers.","MW01-6-189WH (MW189) is a novel central nervous system-penetrant small-molecule drug candidate that selectively attenuates stressor-induced proinflammatory cytokine overproduction and is efficacious in intracerebral hemorrhage and traumatic brain injury animal models. We report first-in-human, randomized, double-blind, placebo-controlled phase 1 studies to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending intravenous doses of MW189 in healthy adult volunteers. MW189 was safe and well tolerated in single and multiple doses up to 0.25 mg/kg, with no clinically significant concerns. The most common drug-related treatment-emergent adverse event was infusion-site reactions, likely related to drug solution acidity. No clinically concerning changes were seen in vital signs, electrocardiograms, physical or neurological examinations, or safety laboratory results. PK analysis showed dose-proportional increases in plasma concentrations of MW189 after single or multiple doses, with approximately linear kinetics and no significant drug accumulation. Steady state was achieved by dose 3 for all dosing cohorts. A pilot pharmacodynamic study administering low-dose endotoxin to induce a systemic inflammatory response was done to evaluate the effects of a single intravenous dose of MW189 on plasma cytokine levels. MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment. The outcomes are consistent with the pharmacological mechanism of MW189. Overall, the safety profile, PK properties, and pharmacodynamic effect support further development of MW189 for patients with acute brain injury.",2020,MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment.,"['healthy adult volunteers', 'Healthy Adult Volunteers', 'patients with acute brain injury']","['MW189', 'endotoxin', 'placebo', 'MW01-6-189WH (MW189']","['plasma concentrations of MW189', 'vital signs, electrocardiograms, physical or neurological examinations, or safety laboratory results', 'safety, tolerability, and pharmacokinetics (PK', 'safety profile, PK properties, and pharmacodynamic effect', 'safe and well tolerated', 'plasma cytokine levels', 'proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}]","[{'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.286496,MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment.,"[{'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Van Eldik', 'Affiliation': 'Sanders-Brown Center on Aging, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Lumy', 'Initials': 'L', 'LastName': 'Sawaki', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Bluegrass Research Consultants, Inc., Versailles, Kentucky, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Noveck', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Hauser', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Jordan', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Tracy G', 'Initials': 'TG', 'LastName': 'Spears', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Watt', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Raja', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Saktimayee M', 'Initials': 'SM', 'LastName': 'Roy', 'Affiliation': 'Department of Pharmacology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'D Martin', 'Initials': 'DM', 'LastName': 'Watterson', 'Affiliation': 'Department of Pharmacology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.795']
317,32172198,Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial.,"BACKGROUND


Cancer-related fatigue (CRF) is a common symptom and has a negative impact on prognosis in cancer patients. CRF could be improved by Korean red ginseng (KRG).
PATIENTS AND METHODS


For this randomised and double-blinded trial, colorectal cancer patients who received mFOLFOX-6 were randomly assigned to either KRG 2000 mg/day (n = 219) or placebo (n = 219) for 16 weeks. CRF was evaluated using the mean area under the curve (AUC) change from baseline of brief fatigue inventory (BFI) as the primary endpoint. Fatigue-related quality of life, stress, and adverse events were evaluated as secondary endpoints.
RESULTS


In the full analysis group, KRG up to 16 weeks improved CRF by the mean AUC change from baseline of BFI compared to placebo, particularly in ""Mood"" and ""Walking ability"" (P = 0.038, P = 0.023, respectively). In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019). Specifically, there were improvements in ""Fatigue right now,"" ""Mood,"" ""Relations with others,"" ""Walking ability,"" and ""Enjoyment of life"" at 16 weeks (P = 0.045, P = 0.006, P = 0.028, P = 0.003, P = 0.036, respectively). In subgroups of female patients, ≥60 years old, with high compliance (≥80%) or more baseline fatigue, the beneficial effects of KRG were more enhanced than that of placebo. Although neutropenia was more frequent in KRG than placebo, the incidence of all adverse events was similar.
CONCLUSIONS


KRG could be safely combined with mFOLFOX-6 chemotherapy in colorectal cancer patients, and reduced CRF compared with placebo.",2020,"In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019).","['colorectal cancer patients', 'cancer patients', 'colorectal cancer patients with', 'colorectal cancer patients who received mFOLFOX-6']","['KRG', 'chemotherapy', 'CRF', 'placebo', 'Korean red ginseng', 'mFOLFOX-6 chemotherapy']","['Fatigue right now,"" ""Mood,"" ""Relations with others,"" ""Walking ability,"" and ""Enjoyment of life', 'CRF', 'Fatigue-related quality of life, stress, and adverse events', 'neutropenia', 'global BFI score', 'Mood"" and ""Walking ability']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life (observable entity)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.673028,"In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019).","[{'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Sae Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, GangNam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Republic of Korea.'}, {'ForeName': 'Jong Gwang', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology/Hematology, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Keon Uk', 'Initials': 'KU', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center, College of Medicine, Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Sun Kyung', 'Initials': 'SK', 'LastName': 'Baek', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Cheul', 'Initials': 'SC', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Ah', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Doyeun', 'Initials': 'D', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Byoungyong', 'Initials': 'B', 'LastName': 'Shim', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dongbok', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Yeul Hong', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: yhk0215@korea.ac.kr.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.018']
318,32227755,Initial Invasive or Conservative Strategy for Stable Coronary Disease.,"BACKGROUND


Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
METHODS


We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction.
RESULTS


Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32).
CONCLUSIONS


Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","['patients with stable coronary disease and moderate or severe ischemia', 'Stable Coronary Disease', '5179 patients with moderate or severe ischemia to an']","['initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed', 'invasive intervention plus medical therapy']","['death from cardiovascular causes or myocardial infarction', 'risk of ischemic cardiovascular events or death', 'definition of myocardial infarction', 'procedural myocardial infarctions of uncertain clinical importance', 'composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'cumulative event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5179.0,0.217237,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mangalath N', 'Initials': 'MN', 'LastName': 'Krishnan', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Whady A', 'Initials': 'WA', 'LastName': 'Hueb', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Miller', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kirby', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Ferguson', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915922']
319,30967657,Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota.,"Many studies have reported abnormal gut microbiota in individuals with Autism Spectrum Disorders (ASD), suggesting a link between gut microbiome and autism-like behaviors. Modifying the gut microbiome is a potential route to improve gastrointestinal (GI) and behavioral symptoms in children with ASD, and fecal microbiota transplant could transform the dysbiotic gut microbiome toward a healthy one by delivering a large number of commensal microbes from a healthy donor. We previously performed an open-label trial of Microbiota Transfer Therapy (MTT) that combined antibiotics, a bowel cleanse, a stomach-acid suppressant, and fecal microbiota transplant, and observed significant improvements in GI symptoms, autism-related symptoms, and gut microbiota. Here, we report on a follow-up with the same 18 participants two years after treatment was completed. Notably, most improvements in GI symptoms were maintained, and autism-related symptoms improved even more after the end of treatment. Important changes in gut microbiota at the end of treatment remained at follow-up, including significant increases in bacterial diversity and relative abundances of Bifidobacteria and Prevotella. Our observations demonstrate the long-term safety and efficacy of MTT as a potential therapy to treat children with ASD who have GI problems, and warrant a double-blind, placebo-controlled trial in the future.",2019,"Important changes in gut microbiota at the end of treatment remained at follow-up, including significant increases in bacterial diversity and relative abundances of Bifidobacteria and Prevotella.","['18 participants two years after treatment was completed', 'children with ASD', 'children with ASD who have GI problems', 'individuals with Autism Spectrum Disorders (ASD']","['MTT', 'placebo', 'Microbiota Transfer Therapy (MTT', 'Microbiota Transfer Therapy']","['autism symptoms and gut microbiota', 'gut microbiota', 'bacterial diversity and relative abundances of Bifidobacteria and Prevotella', 'GI symptoms, autism-related symptoms, and gut microbiota', 'GI symptoms']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0647210', 'cui_str': 'MTTS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0668694,"Important changes in gut microbiota at the end of treatment remained at follow-up, including significant increases in bacterial diversity and relative abundances of Bifidobacteria and Prevotella.","[{'ForeName': 'Dae-Wook', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Biodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Adams', 'Affiliation': 'School for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.'}, {'ForeName': 'Devon M', 'Initials': 'DM', 'LastName': 'Coleman', 'Affiliation': 'School for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.'}, {'ForeName': 'Elena L', 'Initials': 'EL', 'LastName': 'Pollard', 'Affiliation': 'School for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Maldonado', 'Affiliation': 'Biodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McDonough-Means', 'Affiliation': 'Integrative Developmental Pediatrics, Tucson, AZ, 85701, USA.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Caporaso', 'Affiliation': 'Center for Applied Microbiome Science, Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, AZ, 86001, USA.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Krajmalnik-Brown', 'Affiliation': 'Biodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA. dr.rosy@asu.edu.'}]",Scientific reports,['10.1038/s41598-019-42183-0']
320,32151879,Redundant visual signals reduce the intensity of alcohol impairment.,"BACKGROUND


Humans interact with multiple stimuli across several modalities each day. The ""redundant signal effect"" refers to the observation that individuals respond more quickly to stimuli when information is presented as multisensory, redundant stimuli (e.g., aurally and visually), rather than as a single stimulus presented to either modality alone. Studies of alcohol effects on human performance show that alcohol induced impairment is reduced when subjects respond to redundant multisensory stimuli. However, redundant signals do not need to involve multisensory stimuli to facilitate behavior as studies have shown facilitating effects by redundant unisensory signals that are delivered to the ""same sensory"" (e.g., two visual or two auditory signals).
METHODS


The current study examined the degree to which redundant visual signals would reduce alcohol impairment and compared the magnitude of this effect with that produced by redundant multisensory signals. On repeated test sessions, participants (n = 20) received placebo or 0.65 g/kg alcohol and performed a two-choice reaction time task that measured how quickly participants responded to four different signal conditions. The four conditions differed by the modality of the target presentation: visual, auditory, multisensory, and unisensory.
RESULTS


Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions. Both multisensory and unisensory redundant signals reduced the impairing effects of alcohol compared with single signals.
CONCLUSIONS


These findings indicate that the ability of redundant signals to counteract alcohol impairment does not require multisensory input. Duplicate signals to the same modality can also reduce alcohol impairment.",2020,"RESULTS


Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions.",[],['placebo'],"['modality of the target presentation: visual, auditory, multisensory, and unisensory', 'alcohol impairment', 'intensity of alcohol impairment']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0208763,"RESULTS


Alcohol slowed performance in all conditions and reaction times were generally faster in the redundant signal conditions.","[{'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, 110 Kastle Hall, Lexington, KY, 40506-0044, USA. Electronic address: fillmore@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107945']
321,32229417,Patients' education level and treatment modality for prostate cancer in the Finnish Randomized Study of Screening for Prostate Cancer.,"BACKGROUND


In prostate cancer (PCa), lower education level is associated with less screening, more advanced stage at diagnosis and worse survival. The aim of this study was to estimate the association between education level and treatment modality and subsequently survival.
METHODS


The 9255 men diagnosed with PCa in the Finnish Randomized Study of Screening for Prostate Cancer were included. Cancer stage, comorbidity, education level and primary treatment modality were extracted from the patient records, the Finnish Cancer Registry, Statistics Finland and the National Institute of Health and Welfare, and these covariates were used in logistic regression (treatment selection) and Cox regression (survival analysis).
RESULTS


In high-risk cancers, men with tertiary education were more likely to be treated with radical prostatectomy (odds ratio [OR] = 1.76; 95% confidence interval [CI] = 1.27-2.44) than men with primary education. Men with secondary (OR = 0.57; 95% CI = 0.38-0.84) or tertiary (OR = 0.42; 95% CI = 0.29-0.60) education were managed less frequently with mere hormonal therapy. In locally advanced cases, tertiary education was associated with more curatively aimed therapies and less hormonal therapy (OR for radical prostatectomy = 2.34; 95% CI = 1.49-3.66; OR for radiotherapy = 1.42; 95% CI = 1.09-1.85; OR for hormonal therapy = 0.45; 95% CI = 0.33-0.60). The hazard ratio for PCa death was lower in men with secondary (0.81; 95% CI = 0.69-0.95) and tertiary (0.75; 95% CI = 0.65-0.87) education than in the patients with primary education.
CONCLUSIONS


When controlled for the cancer risk group, comorbidity and patient's age, low education level is independently associated with less curatively aimed treatment in men with high-risk or locally advanced PCa and subsequently worse prognosis.",2020,"The hazard ratio for PCa death was lower in men with secondary (0.81; 95% CI = 0.69-0.95) and tertiary (0.75; 95% CI = 0.65-0.87) education than in the patients with primary education.
","['men with high-risk or locally advanced PCa and subsequently worse prognosis', '9255 men diagnosed with PCa in the Finnish Randomized Study of Screening for Prostate Cancer were included']",['radical prostatectomy'],['hazard ratio for PCa death'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",9255.0,0.204265,"The hazard ratio for PCa death was lower in men with secondary (0.81; 95% CI = 0.69-0.95) and tertiary (0.75; 95% CI = 0.65-0.87) education than in the patients with primary education.
","[{'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: tuomas.kilpelainen@hus.fi.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Raitanen', 'Affiliation': 'UKK Institute for Health Promotion Research, Tampere, Finland; Faculty of Social Sciences (Health Sciences), Tampere University, Tampere, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Pylväläinen', 'Affiliation': 'Department of Radiology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo Lj', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Faculty of Social Sciences (Health Sciences), Tampere University, Tampere, Finland.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.045']
322,32234665,Randomised phase II trial (SWOG S1310) of single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine in refractory advanced biliary cancer.,"BACKGROUND


The rationale for the evaluation of trametinib in advanced biliary cancer (BC) is based on the presence of mitogen-activated protein kinase alterations and on earlier promising results with MEK inhibitors in BC.
METHODS


Patients with histologically proven BC who progressed on gemcitabine/platinum were randomised to trametinib daily (arm 1) versus fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2). The primary end-point was overall survival (OS). Secondary end-points included progression free survival (PFS) and response rate. A planned interim futility analysis of objective response was performed on the first 14 patients registered to the trametinib arm.
RESULTS


The study was stopped early based on the lack of measurable response in the trametinib arm. A total of 44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2). Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32%). The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99) Median OS was 4.3 months for arm 1 and 6.6 months for arm 2. The median PFS was 1.4 months for arm 1 and 3.3 months for arm 2.
CONCLUSIONS


This is the first prospective randomised study of a targeted agent versus chemotherapy for the second-line treatment of BC. In this unselected population, the interim analysis result of unlikely benefit with trametinib resulted in early closure.",2020,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"['refractory advanced biliary cancer', '14 patients registered to the trametinib arm', 'advanced biliary cancer (BC', '44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2', 'Patients with histologically proven BC who progressed on', 'Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32']","['single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine', 'fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2', 'chemotherapy', 'gemcitabine/platinum']","['overall survival (OS', 'overall response rate', 'median PFS', 'progression free survival (PFS) and response rate', 'Median OS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",44.0,0.105151,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Kim', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. Electronic address: Richard.Kim@moffitt.org.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Stein', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Keogh', 'Affiliation': 'Charleston Hematology Oncology Associates, Southeast COR NCORP, Charleston, SC, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center/Sutter Cancer Research Consortium, San Francisco, CA, USA.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'Columbia University, Columbia MU-NCORP, New York, NY, USA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.026']
323,32250331,Dose and staffing comparison study of upper limb device-assisted therapy.,"BACKGROUND


Neurological injuries cause persistent upper extremity motor deficits. Device-assisted therapy is an emerging trend in neuro-rehabilitation as it offers high intensity, repetitive practice in a standardized setting.
OBJECTIVE


To investigate the effects of therapy duration and staff-participant configuration on device-assisted upper limb therapy outcomes in individuals with chronic paresis.
METHODS


Forty-seven participants with chronic upper extremity weakness due to neurological injury were assigned to a therapy duration (30 or 60 min) and a staff-participant configuration (1-to-1 or 1-to-2). Therapy consisted of 3 sessions a week for 6 weeks using the Armeo®Spring device. Clinical assessments were performed at three timepoints (Pre, Post, and 3 month Follow up).
RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups. FM improvement was comparable between 30 and 60 min sessions, but participants in the 1-to-2 group had significantly greater improvement in FM from Pre-to-Post and from Pre-to-Follow up than the 1-to-1 group.
CONCLUSIONS


Device-assisted therapy can reduce upper limb impairment to a similar degree whether participants received 30 or 60 min per session. Our results suggest that delivering therapy in a 1-to-2 configuration is a feasible and more effective approach than traditional 1-to-1 staffing.",2020,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","['Forty-seven participants with chronic upper extremity weakness due to neurological injury', 'individuals with chronic paresis']","['Device-assisted therapy', 'upper limb device-assisted therapy']","['FM', 'upper limb impairment', 'Fugl-Meyer score (FM', 'FM improvement']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0446229,"RESULTS


Improvements in upper limb impairment, measured by change in Fugl-Meyer score (FM), were observed following therapy in all groups.","[{'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Wuennemann', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Stuart W', 'Initials': 'SW', 'LastName': 'Mackenzie', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Heather Pepper', 'Initials': 'HP', 'LastName': 'Lane', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Avrielle R', 'Initials': 'AR', 'LastName': 'Peltz', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Gerber', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy & Research, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation Research Institute, Elkins Park, PA, USA.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kitago', 'Affiliation': 'Human Motor Recovery Laboratory, Burke Neurological Institute, White Plains, NY, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192993']
324,32250336,Effects of aerobic training on physical activity in people with stroke: A randomized controlled trial.,"BACKGROUND


Individuals with stroke have low physical activity levels and spend high amount of time in low-energy expenditure activities.
OBJECTIVE


To investigate the effects of aerobic treadmill training on physical activity levels and time spent in low-energy expenditure activities (primary outcomes), as well as on cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke.
METHODS


A randomized controlled trial, with 22 adults with chronic stroke was performed. Experimental group: aerobic treadmill training at 60-80% of heart rate reserve.
CONTROL GROUP


outdoor-overground walking below 40% of heart rate reserve. Both groups: three 40 min sessions/week over 12 weeks. Outcomes were measured at baseline, post-training, and 16-week follow-up.
RESULTS


No changes in the primary outcomes were found for any of the groups. The experimental group showed greater improvements in quality of life at 16-week follow-up (13 points;95% CI:3.5-23). Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk test:55 m;95% CI:3.8-107), and mobility (0.12 m/s;95% CI:0.02-0.2).
CONCLUSION


Aerobic treadmill training improved quality of life. Aerobic treadmill training or outdoor-overground walking improved depression, endurance and mobility. Further studies are needed to clarify the effects of aerobic training on physical activity levels and time spent in low-energy expenditure activities after stroke.",2020,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","['people with stroke', '22 adults with chronic stroke']","['aerobic treadmill training', 'GROUP', 'Aerobic treadmill training', 'aerobic training', 'Aerobic treadmill training or outdoor-overground walking']","['depression, endurance and mobility', 'cardiorespiratory fitness, endurance, depression, mobility, quality of life and participation (secondary outcomes) after stroke', 'quality of life', 'physical activity levels and time spent in low-energy expenditure activities', 'mobility', 'depression', 'physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",22.0,0.150659,"Both groups improved depression (2.2 points;95% CI:0.01-4.3), endurance (Six-minute walk test:31 m;95% CI:5.6-57, Incremental shuttle-walk","[{'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Nadeau', 'Affiliation': ""École de Réadaptation, Université de Montréal (UdeM), and Centre de recherche interdisciplinaire en réadaptation (CRIR), Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM), CIUSSS Centre-sud-de-l'Ile-de-Montréal, Montréal, Canada.""}, {'ForeName': 'Raquel Rodrigues', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Luci Fuscaldi', 'Initials': 'LF', 'LastName': 'Teixeira-Salmela', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Júlia Caetano', 'Initials': 'JC', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Giane Amorim Ribeiro', 'Initials': 'GAR', 'LastName': 'Samora', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'João Antônio', 'Initials': 'JA', 'LastName': 'da Silva Júnior', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Christina Danielli Coelho de Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.'}]",NeuroRehabilitation,['10.3233/NRE-193013']
325,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
326,32114185,Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.,"IMPORTANCE


Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.
DESIGN


2-arm randomized controlled efficacy-effectiveness trial.
SETTING


A large non-profit health maintenance organization.
PARTICIPANTS


165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.
INTERVENTIONS


Two sleep interventions, each 6-7 sessions, both overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).
CONCLUSIONS AND RELEVANCE


If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
TRIAL REGISTRATION


clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.",2020,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","['youth', 'A large non-profit health maintenance organization', '165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider']","['cognitive behavioral therapy', 'overlaying ""treatment as usual"" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI', 'SSRI antidepressants']",['depression outcomes'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035168'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",165.0,0.0962211,"If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.
","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Greg.Clarke@kpchr.org.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Sheppler', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Christina.R.Sheppler@kpchr.org.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Firemark', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Alison.J.Firemark@kpchr.org.'}, {'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Rawlings', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Andreea.M.Rawlings@kpchr.org.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: John.F.Dickerson@kpchr.org.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Michael.C.Leo@kpchr.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105967']
327,32114186,Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial).,"Walking interventions can be effective in increasing physical activity amongst physically inactive employees. However, despite their promising potential regarding sustainability and scalability, peer-led workplace walking interventions have not been tested. We evaluated a peer-led workplace group walking intervention designed to engage physically inactive employees. A 16-week pilot cluster randomized controlled trial consisted of enhanced (5 worksites; n = 50 participants) and minimal treatment (3 worksites; n = 47) conditions. All participants were provided with a Fitbit Zip and information on health benefits of walking. Enhanced treatment participants had access to a mobile phone app incorporating behavior change techniques, were trained on principles of autonomous motivation, and had a peer leader trained in a motivationally supportive communication style. Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only). Outcomes assessed included movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures were taken at baseline and post-intervention. The results supported intervention feasibility. Preliminary efficacy evidence was mixed. Markers of cardio-metabolic risk improved in the enhanced treatment only. Autonomous motivation increased in both conditions. There were no changes in step counts, standing, and sitting time, or well-being. Further fine tuning is needed before a definitive RCT. Australian and New Zealand Clinical Trials Registry: ACTRN12618000807257.",2020,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).",['Australian and New Zealand'],"['enhanced (5 worksites; n\u202f=\u202f50 participants) and minimal treatment (3 worksites; n\u202f=\u202f47) conditions', 'peer-led workplace group walking intervention', 'peer-led motivationally-embellished workplace walking intervention', 'Walking interventions']","['step counts, standing, and sitting time, or well-being', 'Markers of cardio-metabolic risk', 'Autonomous motivation', 'movement-related behaviors (assessed via activPAL devices), cardio-metabolic risk factors, motivation to walk, and well-being, and these measures', 'Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043016', 'cui_str': 'Walkers'}]",50.0,0.113263,"Feasibility assessments included recruitment and drop-out rates, assessment completion rates, training acceptability (walkers and peer leaders), and intervention acceptability (walkers only).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia. Electronic address: c.thogersen@curtin.edu.au.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Smith', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nicholas', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'S A M', 'Initials': 'SAM', 'LastName': 'Fenton', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, England.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Centre for Transformative Work Design, Future of Work Institute, Curtin University, Perth, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-Being Research Group, School of Psychology, Curtin University, Perth, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105969']
328,32184197,A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP).,"Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month ""steps"" with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2-3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253.",2020,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,[],"['LDCT', 'Lung cancer screening with low-dose computed tomography (LDCT', 'community-partnered intervention (Toolkit) designed to support primary care practices', 'community intervention']","['adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs', 'delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings', 'lung cancer mortality']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.158435,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,"[{'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Salazar', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: a.salaza@wustl.edu.'}, {'ForeName': 'Subhjit', 'Initials': 'S', 'LastName': 'Sekhon', 'Affiliation': 'University of Missouri-Kansas City, USA. Electronic address: sks3t4@mail.umkc.edu.'}, {'ForeName': 'Karthik W', 'Initials': 'KW', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: karthik.rohatgi@wustl.edu.'}, {'ForeName': 'Akua', 'Initials': 'A', 'LastName': 'Nuako', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aanuako@wustl.edu.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: esther@wustl.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Harriss', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: courtney.harriss@wustl.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: ellen.brennan@bjc.org.'}, {'ForeName': 'Dareld', 'Initials': 'D', 'LastName': 'LaBeau', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: dareld.labeau@bjc.org.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdalla', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: ibrahim.abdalla@coxhealth.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: chris.schulze@coxhealth.com.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Muenks', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: jackie.muenks@coxhealth.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Overlot', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: daveo@dmhhs.org.'}, {'ForeName': 'Jeri Ann', 'Initials': 'JA', 'LastName': 'Higgins', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: jerih@dmhhs.org.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Regional Cancer Center, Memorial Health System, 701 N 1(st), Springfield, IL 62781, USA. Electronic address: jones.linda@mhsil.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Swick', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: cswick@sblhs.org.'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Goings', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: sgoings@sblhs.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badiu', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: jennifer.badiu@sih.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: Justin.Walker@sih.net.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: colditzg@wustl.edu.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aimeejames@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105991']
329,32184198,The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans.,"Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. Participants will be randomly assigned to either written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists. Treatment is terminated before session 8 if the PTSD symptom improvement criterion is met. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up. The primary hypotheses are that written exposure therapy will be noninferior to imaginal exposure with respect to treatment efficacy and efficiency. Secondary hypotheses relate to identifying and comparing potential mediators of PTSD treatment outcome, including trauma-related cognitions and emotion regulation.",2020,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"['posttraumatic stress disorder', 'Veterans with posttraumatic stress disorder (PTSD', '300 Veterans seeking treatment for clinically significant symptoms of PTSD', 'Veterans']","['written exposure therapy versus imaginal exposure for PTSD', 'written exposure therapy versus imaginal exposure delivered online', 'written exposure or imaginal exposure via verbal recounting and will complete between 4 and 8 online therapy sessions facilitated by trained peer support specialists']",['trauma-related cognitions and emotion regulation'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",300.0,0.026439,Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD).,"[{'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA; Stanford University, Department of Psychiatry and Behavioral Sciences, School of Medicine, 401 Quarry Road, Stanford, CA 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gengler', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Prevail Health Solutions, LLC, 105 W Chicago Ave #203, Chicago, IL 60642, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105990']
330,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
331,32228635,Effects of skim milk and isotonic drink consumption before exercise on fluid homeostasis and time-trial performance in cyclists: a randomized cross-over study.,"BACKGROUND


Hydration status affects endurance performance. Pre-exercise hydration recommendations target the consumption of high carbohydrate and sodium beverages. Milk, due to its carbohydrate and sodium content, may be considered an effective pre-exercise hydration beverage.
PURPOSE


In a randomized cross-over trial, we compared the effects of an isotonic sport drink (SPD) with skim milk (SM) consumption before a race, on fluid homeostasis and time-trial performance in road cyclists.
METHODS


Male road cyclists (n = 9; age, 26.8 ± 4.78 years) with 10.8 ± 8.56 years of experience in national competitions, consumed either SPD or SM in doses of 350 mL at 3 h and 350 mL at 1.5 h before a 18.6 km time-trial race. Measurements of body mass, urine specific gravity (USG), urine color and time-trial were compared between drinks (group; g) before and after the race (time; t).
RESULTS


The two-way ANOVA showed no differences between SPD and SM in body mass (t, p < 0.0001; g, p = 0.89; t × g, p = 0.54), USG (t, p = 0.01; g, p = 0.63; t × g, p = 0.29) and urine color (t, p = 0.01; g, p = 0.54; t × g, p = 0.28) before or after race. Furthermore, no differences on water consumption during the race (p = 0.55) or time-trial performance (p = 0.84) were observed between trials.
CONCLUSION


Current results may help athletes with different beverages preferences to increase their options of hydration strategies.",2020,"Furthermore, no differences on water consumption during the race (p = 0.55) or time-trial performance (p = 0.84) were observed between trials.
","['Male road cyclists (n\xa0', '9; age, 26.8\u2009±\u20094.78\u2009years) with 10.8\u2009±\u20098.56\u2009years of experience in national competitions, consumed either SPD or SM in doses of 350\u2009mL at 3\u2009h and 350\u2009mL at 1.5\u2009h before a 18.6\u2009km time-trial race', 'cyclists', 'road cyclists']","['isotonic sport drink (SPD) with skim milk (SM) consumption', 'skim milk and isotonic drink consumption before exercise']","['time-trial performance', 'water consumption', 'Measurements of body mass, urine specific gravity (USG), urine color and time-trial', 'urine color', 'fluid homeostasis and time-trial performance', 'SPD and SM in body mass']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]","[{'cui': 'C0452461', 'cui_str': 'Sports drink (substance)'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0585043', 'cui_str': 'Before exercise (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}, {'cui': 'C0042037'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]",,0.0959336,"Furthermore, no differences on water consumption during the race (p = 0.55) or time-trial performance (p = 0.84) were observed between trials.
","[{'ForeName': 'Danniela', 'Initials': 'D', 'LastName': 'García-Berger', 'Affiliation': 'Nutrition and Exercise laboratory, Faculty of Medicine, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mackay', 'Affiliation': 'School of Exercise and Nutrition, Faculty of Health, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Monsalves-Alvarez', 'Affiliation': 'Human Performance Laboratory, Motion Health & Performance Center, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jorquera', 'Affiliation': 'Nutrition and Exercise laboratory, Faculty of Medicine, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Laboratory of Human Performance. Quality of Life and Wellness Research Group. Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Zbinden-Foncea', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Av. Pedro de Valdivia # 1509, Providencia, Santiago, Chile.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Castro-Sepulveda', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Av. Pedro de Valdivia # 1509, Providencia, Santiago, Chile. mcastro@uft.cl.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00346-9']
332,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
333,32248638,Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial.,"BACKGROUND


Lower-limb amputation (LLA) due to non-traumatic vascular etiology is linked to extremely low physical activity and high disability.
OBJECTIVE


To test the feasibility of a biobehavioral intervention designed to promote physical activity.
DESIGN


A randomized, single-blind feasibility trial with a crossover design.
SETTING


Veterans Administration Medical Center.
PARTICIPANTS


Military veterans (age: 65.7 [7.8] years; mean [standard deviation]) with nontraumatic lower-limb amputation (LLA), randomized to two groups: GROUP1 (n = 16) and GROUP2 (n = 15). Both groups had similar baseline amputation characteristics (level of amputation and time since amputation).
INTERVENTIONS


Twelve weekly, 30-minute telehealth sessions of physical activity behavior-change intervention, with GROUP1 participating in weeks 1-12 and GROUP2 in weeks 13-24. GROUP1 noncontact phase in weeks 13-24 and GROUP2 attention control telehealth phase in weeks 1-12.
MAIN OUTCOME MEASURES


Feasibility (participant retention, dose goal attainment, intervention acceptability [Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale], safety) and signal of efficacy (free-living physical activity [accelerometer-based average daily step count], Late Life Function and Disability Index - Disability Scale [LLFDI-DS]).
RESULTS


Participant retention rate was high (90%), with three participants lost to follow-up during the intervention period. Dose goal attainment was low, with only 10% of participants achieving an a priori walking dose goal. Intervention was rated as acceptable, with mean IMI Interest and Enjoyment score (5.8) statistically higher than the null value of 5.0 (P = .002). There were no between-group differences in adverse event rates (falls: P = .19, lower extremity wounds: P = .60). There was no signal of efficacy for change in average daily step count (d = -0.15) or LLFDI-DS (d = -0.22 and 0.17 for frequency and limitations scales, respectively).
CONCLUSIONS


Telehealth delivered biobehavioral intervention resulted in acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability) for people with nontraumatic LLA.",2020,"There were no between-group differences in adverse event rates (falls: P = 0.19, lower extremity wounds: P = 0.60).","['older Veterans after non-traumatic amputation', 'Military veterans [age: 65.7 (7.8) years; mean (SD)] with non-traumatic lower-limb amputation (LLA', 'Veterans Administration Medical Center']","['biobehavioral intervention', 'Biobehavioral intervention targeting physical activity behavior change', 'GROUP1', 'GROUP2']","['baseline amputation characteristics (level of amputation and time since amputation', 'Feasibility [participant retention, dose goal attainment, intervention acceptability (Intrinsic Motivation Inventory [IMI] Interest and Enjoyment scale), safety] and signal of efficacy [free-living physical activity (accelerometer-based average daily step count), Late Life Function and Disability Index - Disability Scale (LLFDI-DS', 'LLFDI-DS', 'mean IMI Interest and Enjoyment score', 'acceptable participant retention, low dose goal attainment, high participant acceptability, and low safety risk, while having no signal of efficacy (physical activity, disability', 'adverse event rates']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002694', 'cui_str': 'Traumatic amputation'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0041735', 'cui_str': 'United States Veterans Administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0880669,"There were no between-group differences in adverse event rates (falls: P = 0.19, lower extremity wounds: P = 0.60).","[{'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Kline', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Fields', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rocky Mountain Regional Medical Center, Aurora, CO.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sullivan', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'VA Eastern Colorado Geriatric Research, Education, and Clinical Center, Rocky Mountain Regional VA Medical Center, Aurora, CO.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12374']
334,32145441,A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings.,"INTRODUCTION


Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.
METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy - General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).
DISCUSSION


Multilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study. ClinicalTrials.gov Registration #NCT03699748.",2020,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","['community centers participating in the study', 'minority patients diagnosed with cancer in community settings', 'low-income and minority employees diagnosed with cancer in outpatient community settings', 'and minority hourly-wage workers with cancer, in two community settings', 'The ""Lay health worker Educates Engages and Activates Patients to', 'patients newly diagnosed with cancer']","['advance care planning and symptom management among low-income', 'LEAPS intervention', 'Share (LEAPS)"" intervention', 'multi-level intervention']","['quality of life', 'total healthcare use and healthcare costs', 'patient activation, patient satisfaction with healthcare decision-making, and symptom burden']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.104465,"METHODS


The ""Lay health worker Educates Engages and Activates Patients to Share (LEAPS)"" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings.","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America. Electronic address: manalip@stanford.edu.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Khateeb', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA, United States of America; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105971']
335,32147571,A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.,"BACKGROUND


Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS


A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION


This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.",2020,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","['Disease-free breast cancer survivors (n\xa0=\xa0422) who completed', 'Cancer-related fatigue', 'University of Rochester Medical Center (URMC']","['bupropion', 'placebo', 'chemotherapy', 'Behavioral interventions include exercise and cognitive-behavioral therapy']","['efficacy and tolerability', 'cognition and symptomatology', 'fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'cancer-related fatigue', 'quality of life, depression, and drug tolerability']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",422.0,0.134713,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hyo Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Julienne', 'Initials': 'J', 'LastName': 'Bower', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Margarita Bobonis', 'Initials': 'MB', 'LastName': 'Babilonia', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Peppone', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105976']
336,31373271,Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT.,"BACKGROUND


Management of bone and joint infection commonly includes 4-6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes.
OBJECTIVE


To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection.
DESIGN


Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%.
SETTING


Twenty-six NHS hospitals.
PARTICIPANTS


Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively).
INTERVENTIONS


Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm.
MAIN OUTCOME MEASURE


The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data.
RESULTS


Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was -1.38% (90% confidence interval -4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
LIMITATIONS


The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded.
CONCLUSIONS


PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy.
FUTURE WORK


Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN91566927.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 38. See the NIHR Journals Library website for further project information.",2019,"PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
","['Twenty-six NHS hospitals', '1054 participants (527 in each arm', 'Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤\u20097 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively']","['Oral versus intravenous antibiotics', 'PO antibiotic therapy', 'OVIVA (Oral Versus IntraVenous Antibiotics']","['incidence of serious adverse events', 'cost-effectiveness evaluation assessed health resource use and quality-of-life data', 'quality-adjusted life-years', 'proportion of participants experiencing treatment failure within 1 year', 'Treatment failure']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0162643'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1054.0,0.198083,"PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scarborough', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Ho Kwong', 'Initials': 'HK', 'LastName': 'Li', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Rombach', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Zambellas', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'McNally', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Atkins', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kümin', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Lipsky', 'Affiliation': 'Green Templeton College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'Department of Microbiology and Public Health, University Hospital of Wales, Public Health Wales, Cardiff, Wales.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Bose', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Infectious Diseases and Microbiology, Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Mack', 'Affiliation': 'Infectious Diseases and Microbiology, Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Folb', 'Affiliation': 'Department of Microbiology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Moore', 'Affiliation': 'Infectious Diseases and Microbiology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jenkins', 'Affiliation': 'Infectious Diseases, Heart of England NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Infectious Diseases and Microbiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Seaton', 'Affiliation': 'Infectious Diseases and Microbiology, Gartnaval General Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': ""Department of Microbiology and Infectious Diseases, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sandoe', 'Affiliation': 'Department of Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Ila', 'Initials': 'I', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ellis', 'Affiliation': 'Infectious Diseases, Northumbria Healthcare NHS Foundation Trust, Cramlington, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Infectious Diseases Unit, Regional Infectious Diseases Unit, Western General Hospital, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Geue', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scarborough', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'National Infection Service, Public Health England, Horsham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cooke', 'Affiliation': 'Division of Infectious Diseases, Imperial College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bostock', 'Affiliation': ""Patient and Public Representative, Division of Health and Social Care Research, King's College London, , London, UK.""}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khatamzas', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brent', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lomas', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Gundle', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bejon', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23380']
337,32203712,Infant respiratory syncytial virus prophylaxis and nasopharyngeal microbiota until 6 years of life: a subanalysis of the MAKI randomised controlled trial.,"BACKGROUND


Respiratory syncytial virus (RSV) infection during infancy is suggested to cause long-term wheeze. In turn, wheeze has been associated with bacterial dysbiosis of the respiratory tract. We investigated the effects of RSV prophylaxis with palivizumab in otherwise healthy preterm infants on respiratory microbiota composition at 1 year and 6 years of age.
METHODS


In a multicentre, single-blind, randomised, placebo-controlled trial (the MAKI trial), infants born between 32-35 weeks of gestation, in one university and in 15 regional hospitals in the the Netherlands, were randomly assigned (1:1) to receive palivizumab or placebo during the RSV season of their first year of life. Intramuscular injections of palivizumab 15 mg/kg or placebo were given during one RSV season: either from Oct 1, or from discharge from the neonatal unit until March 10 (minimun of 2 and maximum of 5 injections were given). Children were 6 months old or younger at the start of the RSV season; exclusion criteria included congenital heart disease, bronchopulmonary dysplasia, Down's syndrome, or other serious congenital disorders, use of mechanical ventilation at birth, treatment with surfactant, or physician-diagnosed wheeze before the start of the RSV season. Children were followed up for clinical symptoms until 6 years of age. For this subanalysis, we obtained nasopharyngeal swabs from children aged 1 year and 6 years and analysed them using 16S-rRNA sequencing. At 6 years we also measured reversible airway obstruction. The primary outcome was the effect of palivizumab during infancy on the respiratory microbiota composition at age 1 year and 6 years (intention-to-treat analysis). The trial is registered in the ISRCTN registry, number ISRCTN73641710.
FINDINGS


From April 1, 2008, to Dec 31, 2010, 429 infants were enrolled in the MAKI trial (n=214 to the palivizumab group; n=215 to the placebo group). At 1 year, we collected swabs and sequenced DNA from 170 (40%) of 429 children, of which 145 (85%) samples had high-quality DNA. The overall microbiota composition was significantly different (R 2  1·3%; p=0·0185) between the palivizumab group and the placebo group at 1 year of life; children in the palivizumab group had a significantly lower abundance of the Staphylococcus-dominated cluster (odds ratio 0·28 [95% CI 0·11-0·68]; p=0·00394), an increased abundance of biomarker species, such as Klebsiella, and a more diverse set of oral taxa, including Streptococcus spp, compared with children in the placebo group. At 6 years, we collected swabs and sequenced DNA from 349 (88%) of 395 children who completed follow-up, of which 342 (98%) samples had high-quality DNA. The overall microbiota composition was not significantly different between groups at 6 years (R 2  0·6%; p=0·0575); however, children in the palivizumab group had a significantly increased abundance of Haemophilus spp and lower abundance of Moraxella and Neisseriaceae spp compared with children in the placebo group. Absence of PCR-confirmed RSV infection at 1 year was significantly associated with a higher abundance of Haemophilus spp at age 6 years and a significantly lower abundance of Moraxella and Neisseriaceae than children with RSV infection at 1 year. Reversible airway obstruction at 6 years was also positively associated with Haemophilus abundance and negatively associated with the abundance of health-associated taxa, such as Moraxella, Corynebacterium, Dolosigranulum, and Staphylococcus, even after correction for RSV immunoprophylaxis (all: p<0·05). Additionally, reversible airway instruction was associated with significantly higher Streptococcus pneumoniae abundance.
INTERPRETATION


Palivizumab in infancy in otherwise healthy preterm infants is associated with persistent effects on the abundance of specific, potentially pathogenic, microbial taxa in the respiratory tract. Several of the palivizumab-associated biomarker species were associated with reversible airway obstruction at age 6 years. These results warrant further studies to establish the long-term ecological effects and health consequences of palivizumab in infancy.
FUNDING


MedImmune.",2020,The overall microbiota composition was not significantly different between groups at 6 years (,"['otherwise healthy preterm infants', 'otherwise healthy preterm infants on respiratory microbiota composition at 1 year and 6 years of age', '395 children who completed follow-up, of which 342 (98%) samples had high-quality DNA', 'infants born between 32-35 weeks of gestation, in one university and in 15 regional hospitals in the the Netherlands', 'Infant respiratory syncytial virus prophylaxis and nasopharyngeal microbiota until 6 years of life', ""Children were 6 months old or younger at the start of the RSV season; exclusion criteria included congenital heart disease, bronchopulmonary dysplasia, Down's syndrome, or other serious congenital disorders, use of mechanical ventilation at birth, treatment with surfactant, or physician-diagnosed wheeze before the start of the RSV season"", 'children aged 1 year and 6 years and analysed them using 16S-rRNA sequencing', 'From April 1, 2008, to Dec 31, 2010, 429 infants were enrolled in the MAKI trial (n=214 to the palivizumab group; n=215 to the placebo group']","['palivizumab', 'reversible airway instruction', 'palivizumab or placebo', 'palivizumab 15 mg/kg or placebo', 'placebo', 'RSV prophylaxis with palivizumab']","['respiratory microbiota composition at age 1 year and 6 years (intention-to-treat analysis', 'abundance of the Staphylococcus-dominated cluster', 'reversible airway obstruction', 'abundance of biomarker species, such as Klebsiella', 'abundance of Haemophilus spp and lower abundance of Moraxella and Neisseriaceae spp', 'Reversible airway obstruction', 'overall microbiota composition', 'Streptococcus pneumoniae abundance']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0242354', 'cui_str': 'Congenital Disorders'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0421207', 'cui_str': 'Airways obstruction reversible (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0018479', 'cui_str': 'Hemophilus'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026536', 'cui_str': 'Moraxella'}, {'cui': 'C0027576', 'cui_str': 'Neisseriaceae'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}]",429.0,0.544541,The overall microbiota composition was not significantly different between groups at 6 years (,"[{'ForeName': 'Wing Ho', 'Initials': 'WH', 'LastName': 'Man', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands; Spaarne Gasthuis Academy, Hoofddorp and Haarlem, Netherlands; Department of Pediatrics, Leiden University Medical Center, Leiden, Netherlands.""}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'Scheltema', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Clerc', 'Affiliation': ""Medical Research Council-University of Edinburgh Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Spaarne Gasthuis Academy, Hoofddorp and Haarlem, Netherlands.'}, {'ForeName': 'Elisabeth E', 'Initials': 'EE', 'LastName': 'Nibbelke', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Niek B', 'Initials': 'NB', 'LastName': 'Achten', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Arp', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Bont', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Bogaert', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands; Medical Research Council-University of Edinburgh Centre for Inflammation Research, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: d.bogaert@ed.ac.uk.""}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30470-9']
338,31944617,Who benefits from the intervention? Correlates of successful BMI reduction in the Texas Childhood Obesity Demonstration Project (TX-CORD).,"BACKGROUND


Many childhood obesity intervention studies report mean outcomes but do not explore the variation in responses and the characteristics of those who respond well.
OBJECTIVE


To identify child and family characteristics associated with improvement in the primary outcome, %BMI p95  , of the Texas Childhood Obesity Research Demonstration project (TX-CORD).
METHODS


The 12-month TX-CORD secondary prevention study randomized 549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months. A growth mixture model was used to identify mutually exclusive latent %BMI p95  trajectories. Latent class regression tested associations between baseline characteristics and latent class membership.
RESULTS


A 2-class solution emerged after accounting for the effect of intervention randomization. Latent Class 1 participants (86% of sample) were characterized by mild-to-moderate obesity and demonstrated a significantly greater response to the intensive intervention between 0 and 3 months (slope-on-group = -0.931, p = 0.03). A rebound between 3 and 12 months was not significantly different between arms. Latent Class 2 participants (14%), who had severe obesity, demonstrated no difference in response between intervention groups. Characteristics associated with Class 1 membership included younger age (2-5 years vs. 6-12 years: OR 3.70, p = .035) and lower maternal BMI category (< 35 kg/m 2  vs. ≥ 35 kg/m 2  : OR 7.14, p < .0001).
CONCLUSIONS


The optimal target population for the intensive intervention are children who have milder obesity, are younger, and do not have a mother with severe obesity. Children with severe obesity may require different approaches.",2020,A rebound between 3 and 12 months was not significantly different between arms.,"['Children with severe obesity', '549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months', 'children who have milder obesity, are younger, and do not have a mother with severe obesity']",[],"['lower maternal BMI category', 'response to the intensive intervention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",549.0,0.0796709,A rebound between 3 and 12 months was not significantly different between arms.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Barlow', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, Texas.'}, {'ForeName': 'Meliha', 'Initials': 'M', 'LastName': 'Salahuddin', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'University of Texas at Austin Dell Medical School, Austin, Texas.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Butte', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}]",Pediatric obesity,['10.1111/ijpo.12609']
339,31633789,Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression.,"OBJECTIVE


Serotonin norepinephrine reuptake inhibitors (SNRIs) are commonly co-prescribed with opioids for chronic pain. The purpose of this study was to describe pain and mood response to venlafaxine among older adults with chronic low back pain (CLBP) and depression relative to opioid exposure.
DESIGN


Secondary analyses were collected from a randomized clinical trial testing a stepped-care approach to comorbid pain and depression in older patients: the Addressing Depression and Pain Together study (ADAPT: 2010-2016).
SETTING


University-based late-life mental health research clinic.
SUBJECTS


Two hundred twenty-seven adults aged 65+ years with CLBP and depression.
METHODS


Participants received six weeks of lower-dose venlafaxine (≤150 mg/d). Pain and depression were measured each week. Response for both pain and depression at the end of six weeks was defined by a ≥30% improvement on a 0-20 numeric rating scale for low back pain and a Patient Health Questionnaire-9 score ≤5. Opioid exposure was analyzed as prescribed (yes or no) and by morphine equivalent dosing (MED).
RESULTS


Patients co-prescribed an opioid were less likely to report a pain response to venlafaxine. MED was negatively correlated with pain response. Depression response was not impacted.
CONCLUSIONS


Opioids are negatively associated with older adults' early analgesic response to lower-dose venlafaxine. These findings suggest that clinicians may wish to consider either nonopioid or alternative antidepressant approaches to pain management in these complex patients. It is reassuring that opioids do not prevent depression response. Future research should examine both longer duration of treatment and a wider range of doses.",2020,"Depression response was not impacted.
","['Two hundred twenty-seven adults aged 65+ years with CLBP and depression', 'Older Adults with Chronic Low Back Pain and Depression', 'older adults with chronic low back pain (CLBP) and depression relative to opioid exposure', 'University-based late-life mental health research clinic', 'older patients']","['Serotonin norepinephrine reuptake inhibitors (SNRIs', 'venlafaxine', 'nonopioid', 'morphine equivalent dosing (MED', 'stepped-care approach', 'Venlafaxine']","['pain and mood response', 'analgesic response', 'pain response', 'Pain and depression', 'Depression response']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",227.0,0.102578,"Depression response was not impacted.
","[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Changgi', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Departments of Psychiatry.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz279']
340,31764099,Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison.,"BACKGROUND


Antiretroviral treatment (ART) reduces HIV infectiousness but the effect of early ART on sexual behaviour is unclear.
METHODS


We assessed, within the START randomized trial that enrolled HIV-positive adults with CD4 cell count greater than 500 cells/μl, the effect of early (immediate) versus deferred ART on: condomless sex with HIV-serodifferent partners (CLS-D); all condomless sex (CLS); HIV transmission-risk sex (CLS-D-HIV risk, defined as CLS-D and: not on ART or started ART <6 months ago or viral load greater than 200 copies/ml or no viral load in past 6 months), during 2-year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS


Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6 versus 13.1%; difference (95% CI): -0.4% (-3.1 to 2.2%), P = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8 versus 8.3%; difference:2.5% (-0.1 to 5.2%), P = 0.062]; the difference was greater at month 24 [9.3 versus 5.6%; difference: 3.7% (1.0 to 6.4%), P = 0.007], at which time CLS was higher in the immediate arm (20.7 versus 15.7%, P = 0.013). CLS-D-HIV risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2 versus 11%; difference: -10.7% (-12.5 to -8.9%), P < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8 to -5.3%), P < 0.001], because of viral suppression on ART.
CONCLUSION


A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk sex, to a very low absolute level.",2019,"Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6 versus 13.1%; difference (95% CI):","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4 cell count greater than 500\u200acells/μl, the effect of early (immediate) versus deferred ART on: condomless sex with HIV-serodifferent partners (CLS-D); all condomless sex (CLS); HIV transmission-risk sex (CLS-D-HIV risk, defined as CLS-D and: not on ART or started ART <6 months ago or viral load greater than 200 copies/ml or no viral load in past 6 months), during 2-year follow-up']",[],"['CLS-D-HIV risk', 'time CLS', 'sexual behaviour']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",2562.0,0.330459,"Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6 versus 13.1%; difference (95% CI):","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver, Colorado, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, USA.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris, and Department of Infectious Diseases, Hopital Saint-Louis, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona and Viiv Healthcare, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Barbosa de Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
341,31764108,High yield of new HIV diagnoses during active case-finding for tuberculosis.,"OBJECTIVE


To evaluate the utility of a broad and nonspecific symptom screen for identifying people with undiagnosed HIV infection.
DESIGN


Secondary analysis of operational data collected during implementation of a cluster-randomized trial for tuberculosis case detection.
METHODS


As part of the trial, adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya. Adults reporting any symptom were offered HIV testing. We analysed the HIV testing data from this study, using modified Poisson regression, to identify predictors of new HIV diagnoses among adults with symptoms and initially unknown HIV status.
RESULTS


We identified 3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV. The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units. More men were diagnosed with HIV than women, despite fewer men being screened. People who reported 4-5 symptoms were over twice as likely to be diagnosed with HIV compared to those reporting 1-3 symptoms (adjusted prevalence ratio in health facilities = 2.58, 95% CI 1.65-4.05; adjusted prevalence ratio in mobile units = 2.63, 95% CI 1.37-5.03).
CONCLUSION


We observed a high yield of new HIV diagnoses among adults identified by active application of a broad symptom screen. Use of integrated tuberculosis and HIV screening could help close the detection gap for both conditions.",2019,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"['3818 symptomatic adults, referred 1424 (37%) for testing, of whom 1065 (75%) accepted, and 107 (10%) were newly diagnosed with HIV', 'adults with symptoms and initially unknown HIV status', 'adults reporting cough, fever, night sweats, weight loss, or difficulty breathing for any duration in the past month were identified in health facilities and community-based mobile screening units in western Kenya', 'people with undiagnosed HIV infection']",['integrated tuberculosis and HIV screening'],['prevalence of new HIV diagnoses'],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0028081', 'cui_str': 'Night sweats (finding)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0459958', 'cui_str': 'HIV screening test'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.435401,The prevalence of new HIV diagnoses was 21% [95% confidence interval (CI) 17-25%] among those tested in health facilities and 5% (95% CI 4-7%) among those tested in mobile units.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mchembere', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Agaya', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Yuen', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Okelloh', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Millicent', 'Initials': 'M', 'LastName': 'Achola', 'Affiliation': 'Kenya Medical Research Institute, US Army Medical Research Directorate - Kenya, Kisumu, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Opole', 'Affiliation': 'Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cowden', 'Affiliation': 'US Army Medical Research Directorate - Kenya.'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Muttai', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Heilig', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Martien W', 'Initials': 'MW', 'LastName': 'Borgdorff', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Cain', 'Affiliation': 'Centers for Disease Control and Prevention, Kisumu, Kenya.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002354']
342,32249193,Randomized Comparison of Prostatic Artery Embolization versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia.,"PURPOSE


To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification.
RESULTS


Mean Q max  increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001).
CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.",2020,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","['Benign Prostatic Hyperplasia', 'lower urinary symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH', 'men over 60 years of age with LUTS secondary to BPH', 'From November 2014 to January 2017, 45 patients']","['prostatic artery embolization (PAE', 'TURP', 'Prostatic Artery Embolization versus Transurethral Resection', 'transurethral resection of the prostate (TURP', 'PAE']","['changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS', 'QoL improvement', 'mean IPSS reduction', 'adverse events', 'Quality of life (QoL), and prostate volume (PV) changes', 'Adverse events', 'Mean PV reduction', 'Mean Q max']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0429549,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","[{'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Insausti', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: insausti00@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sáez de Ocáriz', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra-Universidad Pública de Navarra, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Pamplona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saioa', 'Initials': 'S', 'LastName': 'Solchaga', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Giral', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Department of Interventional Radiology, Hospital St. Louis, Lisbon, Portugal; Department of Radiology, NOVA Medical School, Lisbon, Portugal; Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Isaacson', 'Affiliation': 'Division of Vascular and Interventional Radiology, Department of Radiology, University of North Carolina Medical Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Urtasun', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saturnino', 'Initials': 'S', 'LastName': 'Napal', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.12.810']
343,32061969,Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families.,"BACKGROUND


Community-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.
METHODS/DESIGN


This two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).
DISCUSSION


AFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier NCT03761589 (12/3/2018).",2020,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","['Latino families', '6- to 11-year-old children (N\u202f=\u202f160) and their parents, relative to a wait-list control group', 'Latino populations', 'Athletes for Life (AFL), a community- and family-based intervention for Latino families', 'primarily Latino families']","['semiweekly sports skill programing and nutrition sessions', 'AFL']","['changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein', 'cardiorespiratory fitness and diet', 'health outcomes', 'Cardiovascular fitness']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.040074,"Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; The University of Texas Health Science Center at Houston, Center for Health Promotion and Prevention Research, 7000 Fannin Street, #1200, Houston, TX 77030, USA; The University of Texas Health Science Center at Houston, Austin Campus, Michael Susan Dell Center for Healthy Living, 1616 Guadalupe Street, Suite 6.300, Austin, TX 78701, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Arizona State University, Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service & Community Solutions, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Arizona State University, Edson College of Nursing and Health Innovation, 550 North 3rd Street, Suite 301, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix Parks and Recreation, 212 East Alta Vista Rd, Phoenix, AZ 85042, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Behar', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA; Mays Cancer Center at UT Health San Antonio MD Anderson, 7979 Wurzbach Rd, San Antonio, TX 78229, USA.'}, {'ForeName': 'Anabell', 'Initials': 'A', 'LastName': 'Lorenzo-Quintero', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann Manrique', 'Affiliation': 'Arizona State University, College of Health Solutions, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'San Diego State University, School of Public Health, 5500 Campanile Drive, San Diego, CA 92182, USA. Electronic address: ncrespo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105956']
344,32064987,Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels.,"In the randomized, phase 3, MDS-005 study (NCT01029262), lenalidomide-induced red blood cell transfusion independence (RBC-TI) in 27% of transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS) ineligible for or refractory to erythropoiesis-stimulating agents. To determine the influence of erythropoietin (EPO) level on response, 155 patients treated with lenalidomide in MDS-005 were categorized into four groups by baseline EPO level. The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups. Achievement of RBC-TI ≥8 weeks inversely correlated with EPO level, ranging from 42.5 to 15.5%. EPO level did not affect erythroid hematologic improvement response (36.2-44.4%). This analysis suggests patients with lower EPO levels experience the strongest benefit from lenalidomide. Although meaningful improvements were observed in some patients with EPO level >500 mU/mL, new treatments are needed for this population.",2020,The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups.,"['red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes', '27% of transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS) ineligible for or refractory to erythropoiesis-stimulating agents', '155 patients treated with lenalidomide in MDS-005']",['erythropoietin (EPO'],"['RBC transfusion burden', 'red blood cell transfusion independence (RBC-TI', 'erythroid hematologic improvement response', 'Achievement of RBC-TI', 'EPO level']","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0133243,The EPO >500 mU/mL group had higher RBC transfusion burden and the lowest proportion of patients with ring sideroblasts ≥15% versus lower EPO groups.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Santini', 'Affiliation': 'MDS Unit, Hematology, AOU Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marien Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Skikne', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Beach', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Tu', 'Affiliation': 'Formerly Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ""Service d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France.""}]",Leukemia & lymphoma,['10.1080/10428194.2020.1719088']
345,31272682,Does aggressive respiratory rehabilitation after primary nuss procedure improve pulmonary function?,"OBJECTIVE


Here, we present the efficacy of an aggressive respiratory rehabilitation program that was initiated from early postoperative period, expecting to improve inspiratory volume at an early stage after primary Nuss procedure.
METHODS


The study was performed as a nonrandomized controlled study undergoing primary Nuss procedure at our institute from 2016 to 2018. We evaluated 34 patients and assigned them to two groups based on whether or not they received a respiratory rehabilitation. Group A (between June 2016 and March 2018) includes patients with inspiratory training postoperatively, and group B (between April 2018 and July 2018) includes patients without training. At the time of admission, a physiatrist provided each patient with a training instruction. From day five postoperatively, the patients in group A started training for inspiration with an incentive spirometer (Coach 2®PORTEX) four times a day. Patients were instructed to perform the same training at home after discharge. Using this device, we measured pre- and postoperative inspired volumes in each group. Data were analyzed with Wilcoxon-Mann-Whitney tests and a paired Student t-test. A p-value below 0.05 was considered statistically significant.
RESULTS


There were no statistically significant differences between the two groups concerning both operative age and the degree of the deformity calculated by Haller index. Preoperative inspiratory volume showed no significant differences. Although there were no statistical differences between two groups in the inspiratory volume at discharge, these two parameters were significantly higher in group A after three months postoperatively (A: 1404 ± 466 ml vs B: 900 ± 314 ml) and the values increased compared to the preoperative stage in group A.
CONCLUSIONS


These data indicate the aggressive respiratory rehabilitation is an effective regimen to increase inspiratory volume at an early stage after Nuss procedure.
LEVEL OF EVIDENCE


III.",2020,There were no statistically significant differences between the two groups concerning both operative age and the degree of the deformity calculated by Haller index.,"['undergoing primary Nuss procedure at our institute from 2016 to 2018', '34 patients']","['respiratory rehabilitation', 'aggressive respiratory rehabilitation program']","['inspiratory volume', 'Preoperative inspiratory volume']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",34.0,0.0145365,There were no statistically significant differences between the two groups concerning both operative age and the degree of the deformity calculated by Haller index.,"[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': ""Nagano Children's Hospital Plastic Reconstructive Surgery, Azumino, Japan. Electronic address: noguchi@nclp.jp.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hoshino', 'Affiliation': ""Nagano Children's Hospital Plastic Reconstructive Surgery, Azumino, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yaguchi', 'Affiliation': ""Nagano Children's Hospital Plastic Reconstructive Surgery, Azumino, Japan.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hizume', 'Affiliation': ""Nagano Children's Hospital Physical Medicine and Rehabilitation, Azumino, Japan.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yuzuriha', 'Affiliation': 'Department of Plastic and Reconstructive Surgery Shinshu University School of Medicine and Graduate School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.05.023']
346,31563548,Neonatal plastibell circumcision: does the thread type matter? a prospective randomized study.,"INTRODUCTION


Plastibell is one of the most common disposable devices used for circumcision. The study aims to determine whether changing the thread type from cotton to polypropylene to tie around the Plastibell in neonatal circumcision would result in faster separation of the ring.
PATIENTS AND METHODS


Prospective, randomized, clinical and biomechanical studies were performed. All circumcisions were performed by a single surgeon. Data collected included anthropometric measures, demographic data, procedure time, complications, parent satisfaction, follow-up, and outcomes. The biomechanical study measured the tensile properties of both threads using a universal testing machine (4465; Instron, Norwood, MA).
RESULTS


Two hundred full-term, male neonates aged between 24 and 48 h were circumcised using Plastibell. Both groups were similar in gestational age, age at circumcision, body weight, height, head circumference, Apgar score at 1 and 5 min, procedure time, Plastibell size, and parent satisfaction. The subjects were randomized into two groups of 100 neonates each: group I where Plastibell was tied by a cotton thread supplied by the manufacturer and group II where Plastibell was tied by Polypropylene 0. The mean duration for Plastibell fall-off was 8.98 days and 7.74 days in cotton thread and Polypropylene 0, respectively (P-value < 0.001). There was no difference regarding the complications for both groups. The diameters of the cotton and Polypropylene 0 threads were 0.68 mm and 0.35 mm, respectively. The measured tensile strengths of cotton and Polypropylene thread were 180 MPa and 457 MPa, respectively.
CONCLUSION


Plastibell tied by Polypropylene 0 fell off faster than that tied by cotton thread, with no significant differences in adverse effects or complications. This finding might be relevant for anxious parents and caregivers. Further studies are needed to examine other types and sizes of threads to investigate whether this separation period can be reduced further.",2019,"Both groups were similar in gestational age, age at circumcision, body weight, height, head circumference, Apgar score at 1 and 5 min, procedure time, Plastibell size, and parent satisfaction.","['Two hundred full-term', 'male neonates aged between 24 and 48\xa0h were circumcised using Plastibell', 'anxious parents and caregivers', '100 neonates each']","['universal testing machine (4465; Instron, Norwood, MA']","['mean duration for Plastibell fall-off', 'adverse effects or complications', 'anthropometric measures, demographic data, procedure time, complications, parent satisfaction, follow-up, and outcomes']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0574086', 'cui_str': 'Plastibell (physical object)'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0574086', 'cui_str': 'Plastibell (physical object)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",200.0,0.0508226,"Both groups were similar in gestational age, age at circumcision, body weight, height, head circumference, Apgar score at 1 and 5 min, procedure time, Plastibell size, and parent satisfaction.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Altokhais', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia. Electronic address: taltokhais@ksu.edu.sa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elsarrag', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alshehri', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albassam', 'Affiliation': 'Department of Surgery, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2019.07.015']
347,32250730,Sporadic Angiomyolipomas Growth Kinetics While on Everolimus: Results of a Phase II Trial.,"PURPOSE


Everolimus decreases tumor volume of renal angiomyolipomas in patients with tuberous sclerosis. No prospective data are available regarding the effect of everolimus on the growth kinetics in patients with sporadic angiomyolipomas. We sought to determine the safety and efficacy of everolimus in the volumetric reduction of sporadic angiomyolipomas.
MATERIALS AND METHODS


This multi-institutional, prospective, phase II trial, enrolled patients with 3 cm or larger sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization. Patients received 10 mg everolimus daily for 4 planned 28-day cycles. Response was defined as a 25% or greater volumetric reduction of patient angiomyolipoma. Baseline, 4, 6 and 12-month volumetric analyses were performed using magnetic resonance imaging. Everolimus was discontinued in those with less than 25% volumetric reduction after 4 cycles. Those with 25% or greater volumetric reduction received 2 additional cycles. The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by 25% or more, and the safety and tolerability of everolimus.
RESULTS


Overall 20 patients were enrolled at 5 centers. Of these patients 11 (55%) completed 4 cycles and 7 (35%) completed 6 cycles. Efficacy was demonstrated, with 10 of 18 (55.6%) patients exhibiting a 25% or greater reduction in tumor volume at 4 months (median 58.5%) and 10 of 14 (71.4%) patients exhibiting a 25% or greater reduction in tumor volume at 6 months (median 58.2%). Four (20%) patients were withdrawn due to protocol defined toxicities and 8 (40%) self-withdrew from the study due to side effects.
CONCLUSIONS


Everolimus was effective in causing volumetric reduction of angiomyolipomas by 25% or greater in most patients but was associated with a high rate of treatment discontinuation.",2020,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus.
","['Sporadic Angiomyolipomas (AMLs', 'patients with sporadic angiomyolipomas', '20 patients were enrolled at 5 centers', 'patients with tuberous sclerosis', 'enrolled patients with ≥3cm sporadic angiomyolipomas who were candidates for surgical resection or percutaneous angioembolization']","['Everolimus (SAGE', 'everolimus', 'Everolimus']","['safety and tolerability of everolimus', 'efficacy of everolimus in the volumetric reduction of angiomyolipomas', 'safety and efficacy', 'tumor volume', 'toxicities', 'volumetric reduction of angiomyolipomas', 'Efficacy', 'Growth Kinetics', 'renal angiomyolipomas']","[{'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1122976', 'cui_str': 'Sage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",20.0,0.03125,"The primary outcomes were the efficacy of everolimus in the volumetric reduction of angiomyolipomas by ≥25% and the safety and tolerability of everolimus.
","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Kadow', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Shuch', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Boorjian', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Surena F', 'Initials': 'SF', 'LastName': 'Matin', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rampersaud', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Barton N', 'Initials': 'BN', 'LastName': 'Milestone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Zibelman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutikov', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Smaldone', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David Yt', 'Initials': 'DY', 'LastName': 'Chen', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Viterbo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreyas', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Greenberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Malizzia', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGowan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Ross', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}]",The Journal of urology,['10.1097/JU.0000000000001065']
348,32251020,The role of organizational learning and resilience for change in building quality improvement capacity in primary care.,"BACKGROUND


The extent that organizational learning and resilience for the change process, that is, adaptive reserve (AR), is a component of building practice capacity for continuous quality improvement (QI) is unknown.
PURPOSE


The aim of the study was to examine the association of AR and development of QI capacity.
METHODOLOGY


One hundred forty-two primary care practices were evaluated at baseline and 12 months in a randomized trial to improve care quality. Practice AR was measured by staff survey along with a validated QI capacity assessment (QICA). We assessed the association of baseline QICA with baseline AR and both baseline and change in AR with change in QICA from 0 to 12 months. Effect modification by presence of QI infrastructure in parent organizations and trial arm was examined.
RESULTS


Mean QICA increased from 6.5 to 8.1 (p < .001), and mean AR increased from 71.8 to 73.9 points (p < .001). At baseline, there was a significant association between AR and QICA scores: The QICA averaged 0.34 points higher (95% CI [0.04, 0.64], p = .03) per 10-point difference in AR. There was a significant association between baseline AR and 12-month QICA-which averaged 0.30 points higher (95% CI [0.02, 0.57], p = .04) per 10 points in baseline AR. There was no association between changes in AR and the QICA from 0 to 12 months and no effect modification by trial arm or external QI infrastructure.
CONCLUSIONS


Baseline AR was positively associated with both baseline and follow-up QI capacity, but there was no association between change in AR and change in the QICA, suggesting AR may be a precondition to growth in QI capacity.
PRACTICE IMPLICATIONS


Findings suggest that developing AR may be a valuable step prior to undertaking QI-oriented growth, with implications for sequencing of development strategies, including added gain in QI capacity development from building AR prior to engaging in transformation efforts.",2020,"There was no association between changes in AR and the QICA from 0 to 12 months and no effect modification by trial arm or external QI infrastructure.
","['primary care', 'One hundred forty-two primary care practices']",[],"['baseline AR and 12-month QICA', 'care quality', 'mean AR', 'Mean QICA', 'AR and QICA scores']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",142.0,0.0322202,"There was no association between changes in AR and the QICA from 0 to 12 months and no effect modification by trial arm or external QI infrastructure.
","[{'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'Linnaea Schuttner, MD, MS, is Investigator, Health Services Research and Development, VA Puget Sound Health Care System, Seattle, Washington, and Acting Instructor of Medicine, Division of General Internal Medicine, University of Washington, Seattle. E-mail: linnaea.schuttner@va.gov. Katie Coleman, MSPH, is Director, MacColl Center for Health Care Innovation, Kaiser Permanente Washington Health Research Institute, Seattle. James Ralston, MD, MPH, is Senior Investigator, Kaiser Permanente Washington Health Research Institute, Seattle. Michael Parchman, MD, MPH, is Senior Investigator, MacColl Center for Health Care Innovation, Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ralston', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Parchman', 'Affiliation': ''}]",Health care management review,['10.1097/HMR.0000000000000281']
349,32119926,A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol.,"Annually approximately 2-3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care. The peer-integrated collaborative care intervention will be supported by a novel emergency department exchange health information technology platform. A total of 424 patients will be randomized to peer-integrated collaborative care (n = 212) and surgical team notification (n = 212) conditions. The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification. These four primary outcomes will be followed-up at 1- 3-, 6-, 9- and 12-months after injury for all patients. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) method will be used to assess implementation processes. Data from the primary outcome analysis and implementation process assessment will be used to inform an end-of-study policy summit with the American College of Surgeons Committee on Trauma. The policy summit will facilitate acute care practice changes related to patient-centered care transitions over the course of a single 5-year funding cycle. Trial registration: (Clinicaltrials.govNCT03569878).",2020,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","['424 patients will be randomized to peer-integrated collaborative care (n\u202f=\u202f212) and surgical team notification (n\u202f=\u202f212) conditions', 'integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consultation as enhanced usual care']","['information technology enhanced peer-integrated collaborative care intervention', 'peer integrated collaborative care intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}]",[],424.0,0.135098,"The study hypothesizes that patient's randomized to peer integrated collaborative care intervention will demonstrate significant reductions in emergency department health service utilization, severity of patient concerns, post traumatic stress disorder symptoms, and physical limitations when compared to surgical team notification.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Scheuer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: hscheuer@uw.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Engstrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alliengs@uw.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Powers Pyles Sutter & Verville PC, 501 M Street, NW, Seventh Floor, Washington, DC 20005, United States of America. Electronic address: Peter.Thomas@PowersLaw.com.'}, {'ForeName': 'Rddhi', 'Initials': 'R', 'LastName': 'Moodliar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: rddhim@uw.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moloney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: kmoloney@uw.edu.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Walen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: marylouw@uw.edu.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: peej23@uw.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: saraseo@uw.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Vaziri', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: nvaziri@uw.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: alvmarti@uw.edu.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ronmaier@uw.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: jerusso@uw.edu.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Sieber', 'Affiliation': 'Molecular Genomics Core/Microarray Group, National Institute of Environmental Health Sciences, P.O. Box 12233, Mail Drop D2-04, Durham, N.C 27709, United States of America. Electronic address: sieber@niehs.nih.gov.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Anziano', 'Affiliation': 'Shepherd Center, 2020 Peachtree Road NW, Atlanta, GA 30309-1465, United States of America. Electronic address: Pete.Anziano@shepherd.org.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America; The Koshka Foundation, United States of America. Electronic address: kanderson@koshkafoundation.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington School of Medicine, 410 9th Ave., Seattle, WA 98104, United States of America. Electronic address: ebulger@uw.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Department of Emergency Medicine, University of Washington School of Medicine, 325 9th Ave., Seattle, WA 98104, United States of America. Electronic address: laurenkw@uw.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington School of Public Health, 1705 NE Pacific St., Seattle, WA 98195, United States of America. Electronic address: heagerty@uw.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Palinkas', 'Affiliation': 'Department of Children, Youth and Families, USC Suzanne Dworak-Peck School of Social Work, 669 W 34(th) St., Los Angeles, CA 90089, United States of America. Electronic address: palinkas@usc.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Ave., Box 359911, Seattle, WA 98104, United States of America. Electronic address: dzatzick@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105970']
350,32145440,Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.,"BACKGROUND


Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.
METHODS


We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up.
CONCLUSION


GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.",2020,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"['176 patients', 'patients with PAD experience claudication despite adequate medical and/or surgical management', 'patients with lower extremity PAD']","['GM-CSF', 'placebo', 'Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF', 'granulocyte-macrophage colony stimulating factor', 'placebo group receive matching placebo injections', 'placebo injections']",['change in 6-min walk distance between baseline and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.40022,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Rogers', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Devinder S', 'Initials': 'DS', 'LastName': 'Dhindsa', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Risha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Martini', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahadev', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Iraj G', 'Initials': 'IG', 'LastName': 'Hesaroieh', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Frohwein', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kutner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Wells', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Duwayri', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Alabi', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Brewster', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. Electronic address: Aquyyum@Emory.Edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105975']
351,32092439,Evaluating the effect of individually-targeted food incentives on grocery purchases: The smart cart study protocol for a randomized controlled cross-over trial.,"BACKGROUND/AIMS


Health stakeholders are interested in the promise of healthy food incentives to improve dietary quality. The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
DESIGN


Randomized controlled crossover design of 224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires. Participants were randomized using 1:1 blocked randomization; all participants received a 5% discount on their purchases with their loyalty card. For the first 13-weeks, the intervention group received individually-targeted weekly coupons (valued up to $10) with brief nutrition education to improve grocery purchase quality. The study team developed healthy food coupons, and the study algorithm allocated targeted coupons to participants' loyalty cards using purchase history, dietary preferences/allergies, and baseline diet quality. Control participants received weekly untargeted nutrition education and occasional generic coupons. Following a 2-4 week washout period, the two groups crossed over. The primary study outcomes were purchases of targeted products and grocery purchase quality measured using the validated Grocery Purchase Quality Index-2016; the study was powered to detect a minimum 3% difference in purchase quality.
CONCLUSIONS


The Smart Cart Study tested a novel application of automated individually-targeted marketing using customer purchase history, dietary quality, and preferences to identify and deliver targeted incentives to improve grocery purchase quality. Future research could scale this program through collaboration between multiple stakeholders, including supermarkets, workplace wellness initiatives and insurance companies.",2020,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[""224 adults who shopped at an independent supermarket for ≥50% of their groceries, participated in the store's loyalty program, and completed validated diet and sociodemographic/behavioral questionnaires""]","['untargeted nutrition education and occasional generic coupons', 'individually-targeted weekly coupons (valued up to $10) with brief nutrition education']","['purchase quality', 'purchases of targeted products and grocery purchase quality']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0700383', 'cui_str': 'Shop (environment)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",224.0,0.0760648,"The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality.
","[{'ForeName': 'Maya K', 'Initials': 'MK', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America. Electronic address: Maya_vadiveloo@uri.edu.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Haley W', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, College of Health Sciences, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Perraud', 'Affiliation': 'AgroParis Tech., 75231 Paris, Ile-de-France, France.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Atlas', 'Affiliation': 'Marketing Area, College of Business Administration, University of Rhode Island, Kingston, RI, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'General Internal Medicine Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105966']
352,32092636,Current cannabis use and smoking cessation among treatment seeking combustible smokers.,"INTRODUCTION


Combustible tobacco smoking and cannabis use frequently occur together, and the use of both substances is associated with overall greater severity of tobacco and cannabis related problems. Observational work has found that cannabis use is associated with tobacco cessation failure, but research directly testing the longitudinal associations of cannabis use on tobacco cessation during smoking cessation treatment is lacking. The current study examined the impact of current cannabis use on combustible tobacco cessation outcomes.
METHODS


207 daily combustible tobacco smokers (M age  = 38.24 years, SD = 14.84, 48.1 % male) were enrolled in a randomized controlled smoking cessation trial. Survival analyses and multi-level modeling were used to assess lapse and relapse behavior through 12-week follow up. The current study is a secondary data analysis.
RESULTS


Results of the current study suggest that cannabis use is associated with faster time to lapse (OR = 0.644, se = .188, p =  .019), but not relapse (OR = -0.218, se = .403, p =  .525), compared to combustible tobacco-only smokers. Additionally, cannabis use was associated with lower likelihood of achieving any 7-day point prevalence abstinence during the 12 week follow up (b = 0.93, se = 0 0.24, p =  0.0001).
CONCLUSIONS


The current study provides novel evidence that cannabis use may be related to combustible tobacco use in terms of faster time to lapse and lower likelihood of any 7-day point prevalence abstinence following smoking cessation treatment. Developing integrated cannabis-tobacco cessation treatments is an important next step in research focused on tobacco-cannabis use.",2020,"Additionally, cannabis use was associated with lower likelihood of achieving any 7-day point prevalence abstinence during the 12 week follow up (b = 0.93, se = 0 0.24, p =  0.0001).
","['SD\u2009=\u200914.84, 48.1 % male', '207 daily combustible tobacco smokers (M age \u2009=\u200938.24\u2009years']",[],"['faster time to lapse', 'lower likelihood of achieving any 7-day point prevalence abstinence']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",207.0,0.0442359,"Additionally, cannabis use was associated with lower likelihood of achieving any 7-day point prevalence abstinence during the 12 week follow up (b = 0.93, se = 0 0.24, p =  0.0001).
","[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Rogers', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Shepherd', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Buckner', 'Affiliation': 'Department of Psychology, Louisiana State University, Baton Rouge, LA, United States.'}, {'ForeName': 'Lorra', 'Initials': 'L', 'LastName': 'Garey', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Manning', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Orr', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States; Department of Behavioral Sciences, University of Texas MD Anderson Cancer Center, Houston, TX, United States; HEALTH Institute, University of Houston, Houston, TX, United States. Electronic address: mjzvolen@central.uh.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107928']
353,32145713,Combined non-intubated anaesthesia and paravertebral nerve block in comparison with intubated anaesthesia in children undergoing video-assisted thoracic surgery.,"BACKGROUND


This study is to investigate if non-intubated anaesthesia combined with paravertebral nerve block (PVNB) can enhance recovery in children undergoing video-assisted thoracic surgery (VATS).
METHODS


A randomized controlled trial including 60 patients aged 3 to 8 years old who underwent elective VATS was performed. They were randomly assigned to receive non-intubated anaesthesia combined with PVNB or general anaesthesia with tracheal intubation (1:1 ratio). The primary outcome was the length of postoperative in-hospital stay. The secondary outcomes included emergence time, the incidence of emergence delirium, time to first feeding, time to first out-of-bed activity, pain score and in-hospital complications.
RESULTS


The non-intubated group had shorter postoperative in-hospital stay than the control group (4 days [IQR, 4-6] vs 5 days [IQR, 5-8], 95% CI 0-2; P = .013). When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01-11.41; P = .043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group. In contrast, the incidence of airway complications was higher in the control than the intervention group (27.6% vs 6.9%, P = .037). There was no statistical significance in the occurrence of PONV, pneumothorax and other complications between the two groups.
CONCLUSIONS


Non-intubated anaesthesia combined with PVNB enhances recovery in paediatric patients for video-assisted thoracic surgery although further multi-centre study is needed.",2020,"When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01 - 11.41; P = 0.043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group.","['paediatric patients', '60 patients aged 3 to 8 years old who underwent elective VATS was performed', 'children undergoing video-assisted thoracic surgery (VATS', 'children undergoing video-assisted thoracic surgery']","['PVNB', 'Combined non-intubated anaesthesia and paravertebral nerve block', 'non-intubated anaesthesia combined with PVNB or general anaesthesia with tracheal intubation (1:1 ratio', 'intubated anaesthesia', 'intubated anaesthesia combined with paravertebral nerve block (PVNB']","['occurrence of PONV, pneumothorax and other complications', 'incidence of airway complications', 'shorter postoperative in-hospital stay', 'emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil', 'emergence time, the incidence of emergence delirium, time to first feeding, time to first out-of-bed activity, pain score and in-hospital complications', 'length of postoperative in-hospital stay', 'incidence of emergence delirium']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia (procedure)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",60.0,0.135181,"When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01 - 11.41; P = 0.043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Tianyun', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xingrong', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Anaethetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13572']
354,31821623,Quantitative electrical pain threshold assessment in the lower urinary tract.,"AIMS


Assessing the reliability of electrical pain threshold (PT) and evaluating the impact of stimulation frequency at different locations in the healthy lower urinary tract (LUT).
METHODS


Ninety subjects (age: 18.3-35.8 years, 40 females, 50 males) were randomly allocated to one stimulation site (bladder dome [BD], trigone, proximal, membranous (only males), or distal urethra). Using 0.5 Hz/1.1 Hz/1.6 Hz electrical stimulation (square wave, pulse width:1 ms), current perception thresholds (CPTs), PTs and tolerance thresholds were assessed at two visits. Analyses were performed using linear mixed models, intraclass correlation coefficients (ICC) and Bland-Altman method.
RESULTS


PTs vary in relation to stimulation frequency, location and between genders. PT decreased with higher stimulation frequency. The highest PTs were measured at the BD and membranous urethra with males reporting higher PTs than females. Reliability of PT assessments according to ICC was good to excellent across all frequencies, locations, and genders (ICC = 0.61-0.97), except for BD and distal urethra in females showing poor to fair reliability (BD: all frequencies, distal urethra: 0.5 Hz).
CONCLUSIONS


PTs can be safely and reliably assessed from bladder and urethral locations. Semi-objective PT assessment may provide additional information on functionality and sensitivity of the LUT slow fiber afferents and complement findings from urodynamic investigations and CPT assessments. In conclusion, the developed methodology may open new opportunities for using electrical stimulation paradigms for LUT PT assessments and diagnostics. All this allows a more precise, location-specific characterization of pain origin and pain reaction towards therapy.",2020,PT decreased with higher stimulation frequency.,"['Ninety subjects (age: 18.3-35.8 years, 40 females, 50 males', 'healthy lower urinary tract (LUT']","['electrical pain threshold (PT', 'stimulation site (bladder dome [BD], trigone, proximal, membranous (only males), or distal urethra']","['current perception thresholds (CPTs), PTs and tolerance thresholds']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0444914', 'cui_str': 'Domed (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205287', 'cui_str': 'Membranous (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",90.0,0.030283,PT decreased with higher stimulation frequency.,"[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc., Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}]",Neurourology and urodynamics,['10.1002/nau.24225']
355,32250328,"Effects of dynamic core-postural chain stabilization on diaphragm movement, abdominal muscle thickness, and postural control in patients with subacute stroke: A randomized control trial.","BACKGROUND


Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise is effective for improving core stability and postural control in stroke patients.
OBJECTIVE


To compare the effects of DNS and conventional NDT exercises on diaphragm movement, abdominal muscle thickness, and postural control in stroke patients.
METHODS


The participants were randomly allocated into DNS (n = 16) and NDT (n = 15) for 30 minutes each per day, 3 days a week for 4 weeks. Diaphragm movement and abdominal muscle thickness were determined using ultrasonography. The trunk impairment scale (TIS) and Berg Balance Scale (BBS) were used to measure postural control. The functional ambulation category (FAC) was used to evaluate gait ability. Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
RESULTS


ANCOVA revealed the superior effects of DNS in diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests, compared with those of NDT (p < 0.05).
CONCLUSIONS


This novel clinical trial suggests that DNS training was more effective than NDT training in improving postural movement control and gait ability via a balanced co-activation of the diaphragm and TrA/IO in stroke patients.",2020,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","['patients with subacute stroke', 'stroke patients']","['DNS and conventional NDT exercises', 'NDT training', 'dynamic core-postural chain stabilization', 'Neurodevelopmental treatment (NDT) and Dynamic neuromuscular stabilization (DNS)-based exercise', 'DNS training', 'DNS', 'NDT']","['functional ambulation category (FAC', 'trunk impairment scale (TIS) and Berg Balance Scale (BBS', 'diaphragm movement and abdominal muscle thickness (transversus abdominis, internal oblique), as well as clinical BBS and FAC tests', 'postural movement control and gait ability', 'diaphragm movement, abdominal muscle thickness, and postural control', 'Diaphragm movement and abdominal muscle thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0224376', 'cui_str': 'Internal Oblique Muscle'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.040415,"Analysis of covariance (ANCOVA) was used to evaluate post-test differences in the DNS and NDT exercise groups.
","[{'ForeName': 'Hyun Sik', 'Initials': 'HS', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Joshua Sung Hyun', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Movement Healing Laboratory, The Graduate School, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-192983']
356,32250330,"Testosterone replacement in hypogonadal men during inpatient rehabilitation following traumatic brain injury: Results from a double-blind, placebo-controlled clinical pilot study.","BACKGROUND


Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
OBJECTIVE


Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
DESIGN


Randomized, double blind, placebo-controlled pilot trial.
SETTING


Inpatient rehabilitation brain injury unit.
PARTICIPANTS


Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
INTERVENTIONS


Transdermal T gel or placebo.
MAIN OUTCOME MEASURES


Revised FIM™ score, strength, adverse events.
RESULTS


Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
CONCLUSIONS


Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.",2020,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","['Inpatient rehabilitation brain injury unit', 'Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into', 'Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation', 'hypogonadal men following TBI in acute rehabilitation', 'hypogonadal men during inpatient rehabilitation following traumatic brain injury']","['Testosterone replacement', 'placebo', 'testosterone (T) therapy', 'Transdermal T gel or placebo', 'Placebo', 'physiologic T therapy']","['FIM™ scores and grip strength', 'Percentage of time with agitation or aggression', 'feasibility, safety, and efficacy', 'absolute functional and strength improvement', 'adverse events', 'FIM™', 'Revised FIM™ score, strength, adverse events', 'rates of recovery']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",70.0,0.707248,"There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, slopes t = 0.61, p = 0.5472).","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Ripley', 'Affiliation': 'Shirley Ryan Ability Lab, Chicago, IL, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Gerber', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pretz', 'Affiliation': 'Lead Biostatistician, Johnson and Johnson, Irvine, CA, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Weintraub', 'Affiliation': 'Craig Hospital, Englewood, CO, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Wierman', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, and Rocky Mountain Regional Veterans Affairs Research Service, Aurora, CO, USA.'}]",NeuroRehabilitation,['10.3233/NRE-192992']
357,32151753,Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial.,"A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults-a population disproportionately affected by asthma. The primary goals were to help participants reduce allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change. HIITBAC had two groups: clinic-only and home-visit groups. Both groups received enhanced clinical care, but the home-visit group also received a detailed home assessment and four additional home visits spaced over roughly one year. We recruited 263 participants. Of these, 152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach). Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group. We describe the HIITBAC methodology and cohort, discuss lessons learned about recruitment and retention, and highlight adaptations we implemented to address these lessons.",2020,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","['152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach', 'African-American adults-a population disproportionately affected by asthma', 'HIITBAC had two groups: clinic-only and home-visit groups', 'Houston-area African-American adults with asthma', '263 participants', 'Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group', 'African Americans']","['home-based intervention', 'Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC']","['allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change', 'asthma control and quality of life']","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348027', 'cui_str': 'Irritant (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",263.0,0.076198,"Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group.","[{'ForeName': 'Rebecca Jensen', 'Initials': 'RJ', 'LastName': 'Bruhl', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: Rebecca.J.Bruhl@bcm.edu.'}, {'ForeName': 'William Brett', 'Initials': 'WB', 'LastName': 'Perkison', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Abiodun O', 'Initials': 'AO', 'LastName': 'Oluyomi', 'Affiliation': 'Section of Epidemiology and Population Science, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ellen Baskin', 'Initials': 'EB', 'LastName': 'Fiesinger', 'Affiliation': 'Department of Management, Policy and Community Health, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Abida', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'College of Nursing, Prairie View A&M University, Houston, TX, United States.'}, {'ForeName': 'Winifred J', 'Initials': 'WJ', 'LastName': 'Hamilton', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Butler', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Cellie', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Galvan', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': ""Frene'"", 'Initials': 'F', 'LastName': 'Lacour-Chestnut', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Shereda', 'Initials': 'S', 'LastName': 'Pannell', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Phipps', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Adriene', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'HIITBAC Patient/Stakeholder Advisory Board, Houston, TX, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Boles', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Ritupreet', 'Initials': 'R', 'LastName': 'Virk', 'Affiliation': 'Environmental Health Service, Department of Family & Community Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Guffey', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Ramamurthy', 'Affiliation': 'Office of Research Information Technology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Persse', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States; Emergency Medical Services, Houston Fire Department, City of Houston, TX, United States.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Maffei', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Wenyaw', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Department of Biostatistics, The University of Texas Health Science Center at Houston, School of Public Health, Houston, TX, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Reyes', 'Affiliation': 'U.S. Department of Housing & Urban Development, Washington, DC, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105977']
358,32171937,Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol.,"INTRODUCTION


Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee.
METHODS/DESIGN


150 participants will be enrolled into this randomized controlled trial. Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL). Movement training will promote between-limb symmetry and surgical knee loading during activity-based exercises. Movement training strategies will include real-time biofeedback using in-shoe pressure sensors and verbal, visual, and tactile cues from the physical therapist. The primary outcome will be change in peak knee extension moment in the surgical knee during walking, from before surgery to six months after surgery. Secondary outcomes will include lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA.
DISCUSSION


This study will provide insights into the efficacy of movement training after unilateral TKA, along with mechanisms for optimizing long-term physical function and minimizing negative sequelae of compensatory movement patterns.",2020,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"['150 participants', 'total knee arthroplasty']","['Movement training', 'standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL', 'TKA', 'Total knee arthroplasty (TKA', 'Movement pattern biofeedback training']","['lower extremity movement symmetry during functional tasks, physical function, quadriceps strength, range of motion, satisfaction, adherence, contralateral knee OA progression, and incidence of contralateral TKA', 'risk of osteoarthritis (OA) progression', 'peak knee extension moment in the surgical knee during walking']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",150.0,0.0895054,Participants will be randomly allocated to one of two dose-equivalent treatment groups: standard rehabilitation plus movement training (MOVE) or standard rehabilitation without movement training (CONTROL).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bade', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America. Electronic address: michael.bade@ucdenver.edu.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Christensen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Zeni', 'Affiliation': 'Rutgers University, School of Health Professions, Newark, NJ, United States of America.'}, {'ForeName': 'Cory L', 'Initials': 'CL', 'LastName': 'Christiansen', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Dayton', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Veterans Affairs Rocky Mountain Mental Illness, Research, Education and Clinical Center, VA Eastern Colorado Healthcare System, Aurora, CO, United States of America.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Cheuy', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapsley', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Eastern Colorado VA Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105973']
359,32087340,"The OaSiS trial: A hybrid type II, national cluster randomized trial to implement smoking cessation during CT screening for lung cancer.","INTRODUCTION


When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guidelines for Treating Tobacco Use and Dependence during CT screening for lung cancer.
METHODS AND DESIGN


OaSiS was implemented using a pragmatic effectiveness-implementation hybrid design in 26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP). The 26 sites selected for participation in the OaSiS trial were randomized to receive either a compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care. Usual care sites were given the option to receive the full compendium of implementation strategies at the conclusion of data collection. We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
DISCUSSION


The OaSiS trial was designed to identify opportunities for implementing evidence-based smoking cessation into LDCT lung cancer screening imaging facilities and to establish the effectiveness of these services. We report our study design and evaluation, including strengths of the pragmatic design and the inclusion of a diverse range of screening programs. Establishing these tobacco cessation services will be critical to reducing smoking related morbidity and mortality.",2020,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","['patients undergoing LDCT screening', ""26 imaging clinics across the United States affiliated with the National Cancer Institute's National Community Oncology Research Program (NCORP"", '26 sites selected for participation in the OaSiS trial', 'for lung cancer']","['compendium of implementation strategies to add or enhance smoking cessation services during lung screening or to usual care', 'smoking cessation during CT screening']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],26.0,0.0444411,"We have evaluated both the effectiveness of the implementation strategies to improve smoking cessation at six months among patients undergoing LDCT screening as well as the adoption and sustainability of evidence-based tobacco cessation strategies in imaging clinics.
","[{'ForeName': 'Kristie Long', 'Initials': 'KL', 'LastName': 'Foley', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America. Electronic address: kfoley@wakehealth.edu.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Weaver', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Sutfin', 'Affiliation': 'Social Sciences and Health Policy, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'W Jeffrey', 'Initials': 'WJ', 'LastName': 'Petty', 'Affiliation': 'Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bellinger', 'Affiliation': 'Pulmonology and Critical Care, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spangler', 'Affiliation': 'Family and Community Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stone', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Wake Forest School of Medicine, Department of Implementation Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dressler', 'Affiliation': 'Biostatistics and Data Science, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Lesser', 'Affiliation': 'Internal Medicine, Medical Center Blvd., Winston-Salem, NC 27157, United States of America; Hematology and Oncology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Chiles', 'Affiliation': 'Radiology, Medical Center Blvd., Winston-Salem, NC 27157, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105963']
360,32087342,"The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.","BACKGROUND


Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors.
PURPOSE


Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older.
METHODS


Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months.
CONCLUSIONS


If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.",2020,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","['530 adults, ages 18 and older']","['1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM\u202f+\u202fFB, where participants self-monitor and receive real-time, tailored feedback (FB']",['weight loss'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",530.0,0.0361057,"We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol.","[{'ForeName': 'Lora E', 'Initials': 'LE', 'LastName': 'Burke', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America. Electronic address: lbu100@pitt.edu.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Bambang', 'Initials': 'B', 'LastName': 'Parmanto', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Beatrice', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Cajita', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Loar', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Pulantara', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kariuki', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'University of Pittsburgh, School of Nursing, Department of Health and Community Systems, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Cedillo', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'University of Pittsburgh, Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105958']
361,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
362,31764105,Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.,"OBJECTIVE


To evaluate the association between HIV antiretroviral therapy (ART) and preterm birth (PTB), when defined by gold standard antenatal ultrasound versus newborn exam.
DESIGN


A secondary analysis of the PROMISE 1077BF/1077FF randomized controlled trial, which compared antiretroviral strategies to reduce perinatal HIV transmission and improve maternal health. The trial used newborn exam (i.e. New Ballard Score, NBS) to assess gestational age. This analysis included liveborn singleton pregnancies with both newborn exam and ultrasound data. The primary exposure was the trial's antiretroviral strategies: zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART'). The primary outcome was PTB less than 37 and less than 34 weeks based on the gold standard of ultrasound dating. We evaluated the association between antiretroviral strategy and PTB. We fit multivariable logistic regression models, adjusting for maternal characteristics, obstetric history, and HIV disease severity.
RESULTS


Among 720 assessed pregnant women, PTB less than 37 weeks was 15.4% by NBS and 18.3% by ultrasound. The NBS was specific but not sensitive for PTB less than 37 weeks (92.0% and 48.5%). Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks. These results held for ultrasounds performed less than 24 weeks, and were generally consistent with prior analyses from the PROMISE trial using the NBS.
CONCLUSION


Women starting HIV ART in pregnancy remained at higher risk of PTB when determined by ultrasound, consistent with prior data using newborn exam. However, newborn exam misclassified cases of PTB compared with gold standard ultrasound.",2019,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.",['liveborn singleton pregnancies with both newborn exam and ultrasound data'],"['HIV antiretroviral therapy (ART) and preterm birth (PTB', 'ZDV', ""zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART""]",['perinatal HIV transmission and improve maternal health'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",720.0,0.198607,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.","[{'ForeName': 'Kartik Kailas', 'Initials': 'KK', 'LastName': 'Venkatesh', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Byramiee Jeejeebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}]","AIDS (London, England)",['10.1097/QAD.0000000000002367']
363,32118347,Comparable efficacy with similarly low risk of hypoglycaemia in patient- vs physician-managed basal insulin initiation and titration in insulin-naïve type 2 diabetic subjects: The Italian Titration Approach Study.,"AIMS


People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM.
MATERIALS AND METHODS


ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA 1c  . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events.
RESULTS


Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE): -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference: -0.11% (95% CI: -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms: relative risk of confirmed and/or severe nocturnal (00:00-05:59 hours) hypoglycaemia was 0.77 (95% CI: 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported.
CONCLUSIONS


In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.",2020,"At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms","['355 participants were included in the intention-to-treat population', 'Insulin-naïve adults with T2DM for ≥1\u2009year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides', 'People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin', 'insulin-naïve type 2 diabetic subjects', 'naïve patients with uncontrolled T2DM']","['insulin glargine', 'Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin']","['incidence and rates of hypoglycaemia', 'hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs) and adverse events', 'PROs', 'hypoglycaemia', 'change in HbA 1c  ']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",355.0,0.0960344,"At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms","[{'ForeName': 'Riccardo C', 'Initials': 'RC', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma Italy, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Perseghin', 'Affiliation': 'University of Milan Bicocca, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'University of Padua, Padova, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Aimaretti', 'Affiliation': 'University of the Eastern Piedmont, Vercelli, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Larosa', 'Affiliation': 'Sanofi, Milan, Italy.'}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'Fanelli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3304']
364,32227566,Increasing diversity in the genetic counseling profession: Development of recruitment tools for African American undergraduate students.,"Lack of diversity in the genetic counseling profession has been a concern for over 20 years, with the National Society of Genetic Counselors identifying increasing diversity and inclusion as a strategic focus in 2019. Previous research has revealed potential barriers that could explain the low number of diverse applicants to genetic counseling graduate programs. The aims of this pilot study were to test strategies for participation and site recruitment methods for Historically Black Colleges and Universities (HBCUs) and to evaluate the effectiveness of a brief presentation tailored to African American students. Recruitment emails were sent to career services and 124 biology/psychology department chairs from HBCUs and one predominately white institution with over 10% black student population. There was a 16% response rate through career services and a 25% response rate from department chairs. Different sections of a single biology class at one HBCU were randomly assigned to either attend a class presentation by an African American second-year genetic counseling student and given a brochure detailing the same information (presentation group), or receive a brochure only (brochure group). Ninety students participated in the study: 65 in the presentation group and 25 in the brochure group. All students completed a 10-question knowledge test and were given an email address for further student-initiated contact about genetic counseling. In the presentation group, 65% (42/65) completed the knowledge test with a mean score of 7.59/10. Only one student from the brochure group completed the knowledge test. No students initiated contact to receive additional information about genetic counseling. This study highlights the difficulties in reaching African American students, even through HBCUs. Strategies beyond the use of brochures and presentations will be necessary to attract African American students into the genetic counseling profession.",2020,"In the presentation group, 65% (42/65) completed the knowledge test with a mean score of 7.59/10.","['African American undergraduate students', 'Different sections of a single biology class at one HBCU', 'Recruitment emails were sent to career services and 124 biology/psychology department chairs from HBCUs and one predominately white institution with over 10% black student population', 'African American students', 'Ninety students participated in the study: 65 in the presentation group and 25 in the brochure group', 'reaching African American students', 'Historically Black Colleges and Universities (HBCUs']","['African American second-year genetic counseling student and given a brochure detailing the same information (presentation group), or receive a brochure only (brochure group']","['response rate through career services', 'knowledge test']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",90.0,0.0238064,"In the presentation group, 65% (42/65) completed the knowledge test with a mean score of 7.59/10.","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Price', 'Affiliation': 'Department of Pediatrics, Inova Fairfax Hospital, Annadale, VA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, Arcadia University, Glenside, PA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Valverde', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1280']
365,32087336,Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness.,"BACKGROUND


Cardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.
METHODS/DESIGN


78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.
DISCUSSION


This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02451670.",2020,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"['patients with SMI', '10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit', 'Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal', 'people with serious mental illness', 'people with serious mental illness (SMI', '78 Midwestern primary care clinics']",['clinical decision support (CDS) tool'],"['CV risk', 'total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",10347.0,0.266181,This cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Rossom', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America. Electronic address: rebecca.c.rossom@healthpartners.com.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Waring', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ohnsorg', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}, {'ForeName': 'Allise', 'Initials': 'A', 'LastName': 'Taran', 'Affiliation': 'Essentia Health, Duluth, MN, United States of America.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kopski', 'Affiliation': 'HealthPartners Medical Group, Minneapolis, MN, United States of America.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105964']
366,32087338,The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.,"Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.",2020,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"['Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity', 'individuals with prediabetes', 'Medicaid managed care adults in New York State', 'Medicaid managed care adults in New York state']","['Diabetes Prevention Program (DPP', 'DPP with various incentive strategies based on class attendance and weight loss as follows']","['weight-loss milestone', 'Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss']","[{'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0283401,Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone.,"[{'ForeName': 'Jo-Yu', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: Jo-Yu.Chin@health.ny.gov.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Matson', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: jacqueline.matson@health.ny.gov.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: susan.mccauley@health.ny.gov.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Anarella', 'Affiliation': 'Albany, NY, USA. Electronic address: joeanarella@gmail.com.'}, {'ForeName': 'Foster', 'Initials': 'F', 'LastName': 'Gesten', 'Affiliation': 'New York State Department of Health, Albany, NY, USA. Electronic address: fgesten@nycap.rr.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roohan', 'Affiliation': 'MVP Health Care, Schenectady, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105960']
367,32087339,"Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.","Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.",2020,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","['anxiety disorders', 'individuals with diagnosed anxiety disorders']","['Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program', 'anxiety: Mindfulness meditation versus escitalopram (TAME', 'pharmacotherapy with escitalopram or MBSR']","['Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia', 'key symptom and function measures, as well as tolerability and satisfaction with treatment']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0150277'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0287433,"Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA. Electronic address: eah103@georgetown.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mihriye', 'Initials': 'M', 'LastName': 'Mete', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA; MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Dutton', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington D.C, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, New York University School of Medicine, New York, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105965']
368,32065939,Examining sleep over time in a randomized control trial comparing two integrated PTSD and alcohol use disorder treatments.,"STUDY OBJECTIVES


Insomnia is highly co-occurring with both posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). This is concerning since insomnia contributes to worse substance abuse and PTSD, and a host of negative health consequences. No study has tracked how sleep indices and insomnia change related to integrated PTSD and AUD treatment using evidence-based exposure therapy. This study examined how insomnia changes over time in a randomized control trial of two integrated PTSD and AUD treatments.
METHODS


Participants were 119 adult veterans (90 % male) seeking treatment for AUD and PTSD at a large urban VA. Participants were randomized to either COPE (integrated treatment using prolonged exposure) or Seeking Safety (integrated therapy using cognitive behavioral, interpersonal techniques and case management). Assessments were done at pre- and post-treatment and include: Clinician Administered PTSD Scale, Timeline Follow-back calendar-assisted interview for AU, insomnia severity index (ISI), sleep diary and actigraphy for 7 days.
RESULTS


ISI showed significant decreases, but a majority remained above the clinical cutoff at post-treatment. Wake after sleep onset decreased, but only by 8 min, remaining above clinical thresholds. Decreases in PTSD, but not in heavy drinking, predicted change in ISI. No significant changes were observed in other sleep variables measured.
CONCLUSIONS


Findings suggested some statistical improvements in sleep quality, but sleep indices remained above clinical cut-offs. This study provides evidence that insomnia is an independent disorder and not responsive to PTSD or AUD treatments alone. Sleep symptoms should be assessed and treated in patients with comorbid mental health conditions.",2020,"No significant changes were observed in other sleep variables measured.
","['Participants were 119 adult veterans (90 % male) seeking treatment for AUD and PTSD at a large urban VA', 'patients with comorbid mental health conditions']","['COPE (integrated treatment using prolonged exposure) or Seeking Safety (integrated therapy using cognitive behavioral, interpersonal techniques and case management']","[' Clinician Administered PTSD Scale, Timeline Follow-back calendar-assisted interview for AU, insomnia severity index (ISI), sleep diary and actigraphy for 7 days', 'Sleep symptoms', 'ISI', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0222045'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",119.0,0.0153319,"No significant changes were observed in other sleep variables measured.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Colvonen', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; VA Center of Excellence for Stress and Mental Health, 3350 La Jolla Village Drive, MC 116A, San Diego, CA 92161, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States. Electronic address: Peter.Colvonen@va.gov.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Straus', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, United States; Sierra Pacific Mental Illness Research Education and Clinical Centers, San Francisco VA Healthcare System, United States.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Science, Monash University, Australia.'}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; VA Center of Excellence for Stress and Mental Health, 3350 La Jolla Village Drive, MC 116A, San Diego, CA 92161, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107905']
369,32242288,Effects of the Dating Matters® Comprehensive Prevention Model on Health- and Delinquency-Related Risk Behaviors in Middle School Youth: a Cluster-Randomized Controlled Trial.,"Teen dating violence (TDV) is associated with a variety of delinquent behaviors, such as theft, and health- and delinquency-related risk behaviors, including alcohol use, substance abuse, and weapon carrying. These behaviors may co-occur due to shared risk factors. Thus, comprehensive TDV-focused prevention programs may also impact these other risk behaviors. This study examined the effectiveness of CDC's Dating Matters®: Strategies to Promote Healthy Teen Relationships (Dating Matters) comprehensive TDV prevention model compared to a standard-of-care condition on health- and delinquency-related risk behaviors among middle school students. Students (N = 3301; 53% female; 50% black, non-Hispanic; and 31% Hispanic) in 46 middle schools in four sites across the USA were surveyed twice yearly in 6th, 7th, and 8th grades. A structural equation modeling framework with multiple imputation to account for missing data was utilized. On average over time, students receiving Dating Matters scored 9% lower on a measure of weapon carrying, 9% lower on a measure of alcohol and substance abuse, and 8% lower on a measure of delinquency by the end of middle school than students receiving an evidence-based standard-of-care TDV prevention program. Dating Matters demonstrated protective effects for most groups of students through the end of middle school. These results suggest that this comprehensive model is successful at preventing risk behaviors associated with TDV. clinicaltrials.gov Identifier: NCT01672541.",2020,"On average over time, students receiving Dating Matters scored 9% lower on a measure of weapon carrying, 9% lower on a measure of alcohol and substance abuse, and 8% lower on a measure of delinquency by the end of middle school than students receiving an evidence-based standard-of-care TDV prevention program.","['Students (N\u2009=\u20093301; 53% female; 50% black, non-Hispanic; and 31% Hispanic) in 46 middle schools in four sites across the USA were surveyed twice yearly in 6th, 7th, and 8th grades', 'Middle School Youth', 'middle school students']","[""CDC's Dating Matters®""]",['Health- and Delinquency-Related Risk Behaviors'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022438', 'cui_str': 'Juvenile Delinquency'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0179966,"On average over time, students receiving Dating Matters scored 9% lower on a measure of weapon carrying, 9% lower on a measure of alcohol and substance abuse, and 8% lower on a measure of delinquency by the end of middle school than students receiving an evidence-based standard-of-care TDV prevention program.","[{'ForeName': 'Lianne Fuino', 'Initials': 'LF', 'LastName': 'Estefan', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA. lestefan@cdc.gov.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Vi D', 'Initials': 'VD', 'LastName': 'Le', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Tracy', 'Affiliation': '2M Research, Arlington, TX, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Latzman', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Tharp', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Lang', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Wendy LiKamWa', 'Initials': 'WL', 'LastName': 'McIntosh', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Mailstop S106-10, Atlanta, GA, 30341, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01114-6']
370,31658926,Multi-Session Anodal Prefrontal Transcranial Direct Current Stimulation does not Improve Executive Functions among Older Adults.,"OBJECTIVE


Findings from single-session online studies highlighted the potential of using anodal prefrontal transcranial direct current stimulation (tDCS) to enhance executive functions (EF) in the context of aging. However, tDCS must be executed as a multi-session offline intervention to ascertain its viability in this context. Relatedly, findings from multi-session studies remained inconclusive. To this end, we examined the effects of multi-session anodal prefrontal tDCS on EF in an intervention.
METHOD


The intervention consisted of 15 sessions; in each, healthy older participants (Agemean = 66.7) received either 15 min of 1.5 mA tDCS (Ncompleted = 35) or sham stimulation (Ncompleted = 33) while performing EF training tasks. EF measures were assessed at baseline, post-intervention, and 1-month follow-up. Hierarchical linear models were used to examine the effect of tDCS on EF outcomes.
RESULTS


Both groups of participants did not differ significantly in side effect ratings and attendance. There were no significant tDCS-associated gains in any EF outcomes in the intervention.
CONCLUSIONS


Multi-session prefrontal tDCS did not lead to any significant gains in EF in the current intervention. More research is needed to optimize the use of tDCS before it can be effectively used to enhance EF among older adults.",2020,Both groups of participants did not differ significantly in side effect ratings and attendance.,"['Older Adults', 'healthy older participants (Agemean = 66.7) received', 'older adults']","['multi-session anodal prefrontal tDCS', 'Multi-Session Anodal Prefrontal Transcranial Direct Current Stimulation', 'either 15 min of 1.5 mA tDCS (Ncompleted = 35) or sham stimulation (Ncompleted = 33) while performing EF training tasks', 'anodal prefrontal transcranial direct current stimulation (tDCS']","['Executive Functions', 'EF measures', 'side effect ratings and attendance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0193805,Both groups of participants did not differ significantly in side effect ratings and attendance.,"[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Charlene L M', 'Initials': 'CLM', 'LastName': 'Lam', 'Affiliation': 'The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Idy S C', 'Initials': 'ISC', 'LastName': 'Man', 'Affiliation': 'The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tatia M C', 'Initials': 'TMC', 'LastName': 'Lee', 'Affiliation': 'The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719001206']
371,31577035,Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial.,"Importance


Norepinephrine, the first-line vasopressor for septic shock, is not always effective and has important catecholaminergic adverse effects. Selepressin, a selective vasopressin V1a receptor agonist, is a noncatecholaminergic vasopressor that may mitigate sepsis-induced vasodilatation, vascular leakage, and edema, with fewer adverse effects.
Objective


To test whether selepressin improves outcome in septic shock.
Design, Setting, and Participants


An adaptive phase 2b/3 randomized clinical trial comprising 2 parts that included adult patients (n = 868) with septic shock requiring more than 5 μg/min of norepinephrine. Part 1 used a Bayesian algorithm to adjust randomization probabilities to alternative selepressin dosing regimens and to trigger transition to part 2, which would compare the best-performing regimen with placebo. The trial was conducted between July 2015 and August 2017 in 63 hospitals in Belgium, Denmark, France, the Netherlands, and the United States, and follow-up was completed by May 2018.
Interventions


Random assignment to 1 of 3 dosing regimens of selepressin (starting infusion rates of 1.7, 2.5, and 3.5 ng/kg/min; n = 585) or to placebo (n = 283), all administered as continuous infusions titrated according to hemodynamic parameters.
Main Outcomes and Measures


Primary end point was ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) of commencing study drug. Key secondary end points were 90-day mortality, kidney replacement therapy-free days, and ICU-free days.
Results


Among 868 randomized patients, 828 received study drug (mean age, 66.3 years; 341 [41.2%] women) and comprised the primary analysis cohort, of whom 562 received 1 of 3 selepressin regimens, 266 received placebo, and 817 (98.7%) completed the trial. The trial was stopped for futility at the end of part 1. Median study drug duration was 37.8 hours (IQR, 17.8-72.4). There were no significant differences in the primary end point (ventilator- and vasopressor-free days: 15.0 vs 14.5 in the selepressin and placebo groups; difference, 0.6 [95% CI, -1.3 to 2.4]; P = .30) or key secondary end points (90-day mortality, 40.6% vs 39.4%; difference, 1.1% [95% CI, -6.5% to 8.8%]; P = .77; kidney replacement therapy-free days: 18.5 vs 18.2; difference, 0.3 [95% CI, -2.1 to 2.6]; P = .85; ICU-free days: 12.6 vs 12.2; difference, 0.5 [95% CI, -1.2 to 2.2]; P = .41). Adverse event rates included cardiac arrhythmias (27.9% vs 25.2% of patients), cardiac ischemia (6.6% vs 5.6%), mesenteric ischemia (3.2% vs 2.6%), and peripheral ischemia (2.3% vs 2.3%).
Conclusions and Relevance


Among patients with septic shock receiving norepinephrine, administration of selepressin, compared with placebo, did not result in improvement in vasopressor- and ventilator-free days within 30 days. Further research would be needed to evaluate the potential role of selepressin for other patient-centered outcomes in septic shock.
Trial Registration


ClinicalTrials.gov Identifier: NCT02508649.",2019,"There were no significant differences in the primary end point (ventilator- and vasopressor-free days: 15.0 vs 14.5 in the selepressin and placebo groups; difference, 0.6 [95% CI, -1.3 to 2.4]; P = .30) or key secondary end points (90-day mortality, 40.6% vs 39.4%; difference, 1.1% [95% CI, -6.5% to 8.8%]; P = .77; kidney replacement therapy-free days: 18.5 vs 18.2; difference, 0.3 [95% CI, -2.1 to 2.6]; P = .85; ICU-free days: 12.6 vs 12.2; difference, 0.5 [95% CI, -1.2 to 2.2]; P = .41).","['July 2015 and August 2017 in 63 hospitals in Belgium, Denmark, France, the Netherlands, and the United States, and follow-up was completed by May 2018', ' 828 received study drug (mean age, 66.3 years', 'Patients With Septic Shock', 'Participants\n\n\nAn adaptive phase 2b/3 randomized clinical trial comprising 2 parts that included adult patients (n\u2009=\u2009868) with septic shock requiring more than 5 μg/min of', '868 randomized patients', 'patients with septic shock receiving']","['norepinephrine', 'Norepinephrine', 'Selepressin vs Placebo', 'norepinephrine, administration of selepressin', 'placebo', 'selepressin']","['mesenteric ischemia', 'Median study drug duration', 'peripheral ischemia', 'cardiac arrhythmias', 'Ventilator- and Vasopressor-Free Days', 'cardiac ischemia', 'ventilator- and vasopressor-free days within 30 days', '90-day mortality, kidney replacement therapy-free days, and ICU-free days']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1412000', 'cui_str': 'Mesenteric Ischemia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0235490', 'cui_str': 'Peripheral ischemia (disorder)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",868.0,0.753974,"There were no significant differences in the primary end point (ventilator- and vasopressor-free days: 15.0 vs 14.5 in the selepressin and placebo groups; difference, 0.6 [95% CI, -1.3 to 2.4]; P = .30) or key secondary end points (90-day mortality, 40.6% vs 39.4%; difference, 1.1% [95% CI, -6.5% to 8.8%]; P = .77; kidney replacement therapy-free days: 18.5 vs 18.2; difference, 0.3 [95% CI, -2.1 to 2.6]; P = .85; ICU-free days: 12.6 vs 12.2; difference, 0.5 [95% CI, -1.2 to 2.2]; P = .41).","[{'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Department of Critical Care Medicine, St. Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Blemings', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Carlsen', 'Affiliation': 'StraDevo A/S, Kongens Lyngby, Denmark.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Inserm CIC1435, Dupuytren Teaching Hospital, Limoges, France.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Graves', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Jacobsen', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants LLC, Austin, Texas.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Opal', 'Affiliation': 'Division of Infectious Diseases, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': ""Center for Heart Lung Innovation and the Division of Critical Care Medicine, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.""}, {'ForeName': 'Nis A', 'Initials': 'NA', 'LastName': 'Windeløv', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Nordsjaellands Hospital in Hilleroed, Copenhagen, Denmark.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Muller', 'Affiliation': 'Centre Hospitalier Régional, Hopital de La Source, Orléans, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Bruel', 'Affiliation': 'Fondation Hôpital Saint Joseph. Paris, France.'}, {'ForeName': 'Noëlle', 'Initials': 'N', 'LastName': 'Brulé', 'Affiliation': 'Medical Intensive Care Unit, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Decruyenaere', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Alain-Michel', 'Initials': 'AM', 'LastName': 'Dive', 'Affiliation': 'CHU UCL Manur, Mont-Godinne, Yvoir, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'Clinique Saint-Pierre, Ottignies, Belgium.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Krell', 'Affiliation': 'Eastern Idaho Regional Medical Center, Idaho Falls.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Centre Hospitalier Universitaire de Nîmes, Nîmes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'Lariboisière Hospital, Paris-Diderot University, INSERM UMRS-1144, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Tours, Tours, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Hopital Cochin, Paris, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Dijon, Dijon, France.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Aalborg Universitetshospital, Aalborg, Denmark.'}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Thorsen-Meyer', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Vander Laenen', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Marianne Lauridsen', 'Initials': 'ML', 'LastName': 'Vang', 'Affiliation': 'Randers Regions Hospital, Randers, Denmark.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vignon', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Inserm CIC1435, Dupuytren Teaching Hospital, Limoges, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vinatier', 'Affiliation': 'Centre Hospitalier Departemental de Vendee, La Roche sur Yon, France.'}, {'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Wichmann', 'Affiliation': 'Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St. Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Anne Louise', 'Initials': 'AL', 'LastName': 'Kjølbye', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.14607']
372,32241195,Effect of letrozole for ovulation induction combined with intrauterine insemination on women with polycystic ovary syndrome.,"Objectives:  To evaluate the efficacy and safety of letrozole on ovulation induction and pregnancy in infertility patients with polycystic ovary syndrome (PCOS). In addition, the insulin resistance was analyzed in these patients. Subjects and methods:  Progressive description study with comparison. The study included 80 infertility women divided into two groups: 40 women with PCOS (the study group) and 40 women without PCOS (the control group). The both used letrozole for ovulation induction from cycle day 2. Results:  No differences in the dominant follicle between the study group and the control group (1.16 ± 0.37 follicles and 1.30 ± 0.46 follicles, respectively). The clinical pregnancy rate was 22.5% of the both groups. The average insulin of the study group (10.85 ± 5.84 µUI/ml) and their average HOMA-IR (2.42 ± 1.34) were higher than the control group (7.44 ± 2.84 µUI/ml and 1.57 ± 0.68),  p  < .05. The QUICKI of the study group (0.35 ± 0.29) was lower than the control group (0.36 ± 0.25),  p  < .05. Conclusion:  Letrozole is used to stimulate the ovaries of the infertile women with PCOS combined with intrauterine insemination is the effective treatment. These patients had the high risk of insulin resistance.",2020,"No differences in the dominant follicle between the study group and the control group (1.16 ± 0.37 follicles and 1.30 ± 0.46 follicles, respectively).","['infertile women with PCOS combined with intrauterine insemination', 'women with polycystic ovary syndrome', 'infertility patients with polycystic ovary syndrome (PCOS', '80 infertility women divided into two groups: 40 women with PCOS (the study group) and 40 women without PCOS (the control group']","['Letrozole', 'intrauterine insemination', 'letrozole']","['ovulation induction and pregnancy', 'clinical pregnancy rate', 'high risk of insulin resistance', 'insulin resistance', 'efficacy and safety', 'average HOMA-IR']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.0485468,"No differences in the dominant follicle between the study group and the control group (1.16 ± 0.37 follicles and 1.30 ± 0.46 follicles, respectively).","[{'ForeName': 'Tung Thanh', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'IVF Department, Military Institute of Clinical Embryology and Histology, Military Medical University, Ha Noi, Vietnam.'}, {'ForeName': 'Hang Thi', 'Initials': 'HT', 'LastName': 'Doan', 'Affiliation': 'IVF Department, Military Institute of Clinical Embryology and Histology, Military Medical University, Ha Noi, Vietnam.'}, {'ForeName': 'Lam Hoang', 'Initials': 'LH', 'LastName': 'Quan', 'Affiliation': 'Military Institute of Clinical Embryology and Histology, Military Medical University, Ha Noi, Vietnam.'}, {'ForeName': 'Ngoc Mai', 'Initials': 'NM', 'LastName': 'Lam', 'Affiliation': 'Assisted Reproductive Technique Unit, Phu Tho Obstetrics and Pediatrics center, Viet Tri, Vietnam.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1744556']
373,31442785,The effect of a 12-week home-based walking program on reducing fatigue in women with breast cancer undergoing chemotherapy: A randomized controlled study.,"BACKGROUND


Fatigue is the most common symptom experienced by cancer patients during treatment and can last long after completing treatment. Fatigue in cancer patients who have completed treatment is well known to be reduced by exercise, but the effect of exercise on reducing fatigue in patients under treatment has been inconsistent.
OBJECTIVES


The purposes of this study were to examine short-term and long-term effects of an individually tailored, home-based brisk walking program on reducing fatigue in breast cancer patients under chemotherapy.
DESIGN, SETTING, PARTICIPANTS


For this randomized controlled trial, women were recruited from a medical center in northern Taiwan if they were diagnosed with stages I-III breast cancer and experienced insomnia, fatigue, pain, or depressive symptoms after their first cycle of chemotherapy. Consenting participants (N = 159) were randomly assigned to either an exercise (12-week home-based walking program) group (n = 81) or an attention-control group (n = 78).
METHODS


The 12-week, home-based brisk walking program started on the first day of the third chemotherapy cycle. Fatigue was measured by the Brief Fatigue Inventory. Covariates, i.e., functional performance, sleep disturbance, anxiety, depression, and exercise-related variables, were also measured. Data were collected at baseline, two times during the exercise intervention, and five times after the exercise intervention (eight times in total). The effects of time-varying and time-invariant predictors on fatigue were analyzed by multilevel modeling.
RESULTS


Fatigue levels increased over time for both groups, even after completing treatment. At the end of the 12-week exercise program, the exercise group had less fatigue than the attention-control group, and this group difference was maintained for the whole study period. At the end of exercise program, women who had spent more time exercising before diagnosis had less fatigue than those who had exercised less often. In addition, patients' fatigue levels at various time points fluctuated along with their functional performance, sleep disturbance, and depression.
CONCLUSIONS


Our tailored, home-based brisk walking program effectively reduced fatigue in breast cancer patients under chemotherapy, and this effect lasted after completing treatment.",2019,"At the end of the 12-week exercise program, the exercise group had less fatigue than the attention-control group, and this group difference was maintained for the whole study period.","['breast cancer patients under chemotherapy', 'breast cancer patients under', 'women with breast cancer undergoing chemotherapy', 'cancer patients', 'women were recruited from a medical center in northern Taiwan if they were diagnosed with stages I-III breast cancer and experienced insomnia, fatigue, pain, or depressive symptoms after their first cycle of chemotherapy', 'Consenting participants (N\u2009=\u2009159']","['exercise (12-week home-based walking program) group (n\u2009=\u200981) or an attention-control group', 'individually tailored, home-based brisk walking program', 'chemotherapy', 'home-based walking program']","['fatigue', 'functional performance, sleep disturbance, and depression', 'functional performance, sleep disturbance, anxiety, depression, and exercise-related variables', 'Fatigue levels', 'Fatigue']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3853978'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0334918,"At the end of the 12-week exercise program, the exercise group had less fatigue than the attention-control group, and this group difference was maintained for the whole study period.","[{'ForeName': 'Hsiang-Ping', 'Initials': 'HP', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, Taipei, Taiwan.'}, {'ForeName': 'Tsui-Yun', 'Initials': 'TY', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Yung-Chang', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Branch, Tao-Yuan, Taiwan.'}, {'ForeName': 'Jen-Chen', 'Initials': 'JC', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shiow-Ching', 'Initials': 'SC', 'LastName': 'Shun', 'Affiliation': 'Department of Nursing in College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Sui-Whi', 'Initials': 'SW', 'LastName': 'Jane', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Branch, Tao-Yuan, Taiwan.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; School of Nursing, College of Medicine, Chang Gung University, Tao-Yuan, Taiwan; Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Branch, Tao-Yuan, Taiwan. Electronic address: mechenl@mail.cgu.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.06.007']
374,31686199,"A prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of SNZ TriBac, a three-strain Bacillus probiotic blend for undiagnosed gastrointestinal discomfort.","PURPOSE


This prospective, randomized, double-blind, placebo-controlled, parallel-group study aimed to determine the efficacy and safety of a multistrain (Bacillus coagulans [SNZ 1969], Bacillus clausii [SNZ 1971], and Bacillus subtilis [SNZ 1972]) probiotic blend (SNZ TriBac) in managing symptoms of gastrointestinal (GI) discomfort in the absence of specific pathologies.
METHODS


Sixty adults with symptoms of GI discomfort were enrolled (mean age, 34.89 ± 9.95 years) and randomized to receive either SNZ TriBac or placebo. Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
RESULTS


On day 30, significant improvement with SNZ TriBac was noted in SODA burping/belching (P = 0.025), bloating (P = 0.048), sour taste (P = 0.025), and total (P = 0.007) scores as well as pain (P = 0.003), non-pain (P = 0.04), and satisfaction (P = 0.03) subscores. Significant improvement with SNZ TriBac was also observed in SODA burping/belching (P = 0.011), sour taste (P = 0.011), and total SODA scores (P < 0.001), and in SODA pain (P = 0.005), non-pain (P = 0.06), and satisfaction (P = 0.004) subscores on day 37. No adverse events were reported.
CONCLUSION


Significant improvement in final SODA scores and subscores with SNZ TriBac versus placebo indicates improvement in several symptoms of gastrointestinal discomfort. This multistrain probiotic blend was well tolerated and could be an effective option for treatment of GI discomfort.
TRIAL REGISTRATION


Clinical Trials Registry of India (CTRI/2018/05/014071).",2019,"Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
","['undiagnosed gastrointestinal discomfort', 'Sixty adults with symptoms of GI discomfort were enrolled (mean age, 34.89 ± 9.95 years']","['placebo', 'SNZ TriBac or placebo', 'SNZ TriBac', 'multistrain (Bacillus coagulans [SNZ 1969], Bacillus clausii [SNZ 1971], and Bacillus subtilis [SNZ 1972]) probiotic blend (SNZ TriBac']","['adverse events', 'total SODA scores', 'efficacy and safety', 'sour taste', 'pain', 'bloating', 'Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales', 'SNZ TriBac', 'SODA burping/belching', 'final SODA scores', 'several symptoms of gastrointestinal discomfort', 'non-pain', 'SODA pain', 'satisfaction']","[{'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0014724', 'cui_str': 'Belching'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",60.0,0.425542,"Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
","[{'ForeName': 'Raunak Jay', 'Initials': 'RJ', 'LastName': 'Soman', 'Affiliation': 'Sanzyme Biologics Pvt. Ltd., Plot no. 13, Sagar Society, Road No. 2, Banjara Hills, Hyderabad, 500034, India. Info@sanzymebiologics.com.'}, {'ForeName': 'Malisetty Venkat', 'Initials': 'MV', 'LastName': 'Swamy', 'Affiliation': 'Sanzyme Biologics Pvt. Ltd., Plot no. 13, Sagar Society, Road No. 2, Banjara Hills, Hyderabad, 500034, India.'}]",International journal of colorectal disease,['10.1007/s00384-019-03416-w']
375,32232692,"Prophylactic efficacy of ninjin'yoeito for oxaliplatin-induced cumulative peripheral neuropathy in patients with colorectal cancer receiving postoperative adjuvant chemotherapy: a randomized, open-label, phase 2 trial (HOPE-2).","PURPOSE


Peripheral neuropathy (PN) is an intractable side effect of oxaliplatin, with no effective prophylaxis so far. Ninjin'yoeito (NYT), a Kampo medicine, is protective against oxaliplatin-induced neuronal cell injury in vitro and ameliorates oxaliplatin-induced PN in vivo. Thus, this randomized controlled trial was aimed at clarifying NYT's prophylactic effect for oxaliplatin-induced cumulative PN.
METHODS


52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of capecitabine (2400 mg/m 2 ) plus oxaliplatin (130 mg/m 2 ) at 3-week intervals. They were randomly assigned to NYT administration and non-administration groups. NYT (9.0 g/day) was administered from day 1 of cycle 1 in the NYT group. The NYT was administered orally daily throughout each cycle. The primary endpoint was the grade of cumulative PN at the end of eight cycles. The secondary endpoints included relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS).
RESULTS


40 patients (n = 20 in both groups) completed 8 chemotherapy cycles. The incidence of grade 2 or greater cumulative PN at the 8th chemotherapy cycle was significantly lower in the NYT group (2/20, 10.0%) than in the control group (11/20, 55.0%, P < 0.01). RDI of oxaliplatin was significantly higher in the NYT group than in the control group (P = 0.02). RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
CONCLUSIONS


NYT may reduce the incidence of oxaliplatin-induced cumulative PN and facilitate maintenance of the CapeOX dosing regimen.",2020,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","['52 patients with colorectal cancers of pathological stage 3 received postoperative adjuvant chemotherapy with the CapeOX regimen: eight cycles of', '40 patients (n\u2009=\u200920 in both groups) completed 8 chemotherapy cycles', 'patients with colorectal cancer receiving postoperative adjuvant chemotherapy']","[""ninjin'yoeito for oxaliplatin"", 'oxaliplatin', 'capecitabine (2400\xa0mg/m 2 ) plus oxaliplatin']","['RFS and OS', 'relative dose intensity (RDI) of oxaliplatin, recurrence-free survival (RFS), and overall survival (OS', 'RDI of oxaliplatin', 'incidence of grade 2 or greater cumulative PN', 'grade of cumulative PN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",52.0,0.207819,"RFS and OS were better in the NYT group than in the control group, but the difference was not significant.
","[{'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Motoo', 'Affiliation': 'Department of Medical Oncology, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan. motoo@kanazawa-med.ac.jp.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of General and Gastroenterological Surgery, Kanazawa Medical University, 1-1 Daigaku, Uchinada, Ishikawa, 920-0293, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01648-3']
376,32149716,A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial.,"BACKGROUND


Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms.
OBJECTIVE


This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute's free smoking cessation app, QuitGuide.
METHODS


Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment.
RESULTS


Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group.
CONCLUSIONS


Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200.",2020,"CONCLUSIONS


Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials.","['A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2', 'Of 81 participants, 41 (50%) were women and 55 (68%) were white', 'Adult smokers who attended a clinic-based tobacco cessation program', 'participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline']","['nicotine patches and gum', 'QuitGuide', 'automated smartphone-based smoking cessation intervention (Smart-T2']",['stay quit'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],81.0,0.0934406,"CONCLUSIONS


Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials.","[{'ForeName': 'Emily T', 'Initials': 'ET', 'LastName': 'Hébert', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Chaelin K', 'Initials': 'CK', 'LastName': 'Ra', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Alexander', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Helt', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Moisiuc', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Darla E', 'Initials': 'DE', 'LastName': 'Kendzor', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Damon J', 'Initials': 'DJ', 'LastName': 'Vidrine', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, United States.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Funk-Lawler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Businelle', 'Affiliation': 'Oklahoma Tobacco Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}]",Journal of medical Internet research,['10.2196/16907']
377,30940870,A Pilot Randomised Double-Blind Study of the Tolerability and efficacy of repetitive Transcranial Magnetic Stimulation on Persistent Post-Concussion Syndrome.,"This study investigates the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on persistent post-concussion syndrome (PCS). The study design was a randomized (coin toss), placebo controlled, and double-blind study. Thirty-seven participants with PCS were assessed for eligibility; 22 were randomised and 18 completed the study requirements. Half the participants with PCS were given an Active rTMS intervention and the other half given Sham rTMS over 3 weeks. Follow ups were at the end of treatment and at 30 and 60 days. The primary outcome measure was the Rivermead Post-Concussion Symptoms Questionnaire (RPQ3 & RPQ13). The results indicate participants with more recent injuries (<12 month), who received Active rTMS, showed significant improvements compared to those of: 1) the same subgroup who received Sham, and 2) those with a longer duration of injury (>14 months) who received Active rTMS. This improvement predominantly manifested in RPQ13 in the follow up periods 1 and 2 months after the intervention (RPQ13 change (mean ± SD): at 1 month, Active = -21.8 ± 6.6, Sham = -2.2 ± 9.8; at 2 months, Active = -21.2 ± 5.3, Sham = -5.4 ± 13.7). No improvement was found in the subgroup with longer duration injuries. The results support rTMS as a tolerable and potentially effective treatment option for individuals with a recent (<1 year) concussion.",2019,"This improvement predominantly manifested in RPQ13 in the follow up periods 1 and 2 months after the intervention (RPQ13 change (mean ± SD): at 1 month, Active = -21.8 ± 6.6, Sham = -2.2 ± 9.8; at 2 months, Active = -21.2 ± 5.3, Sham = -5.4 ± 13.7).","['individuals with a recent (<1 year) concussion', 'Thirty-seven participants with PCS were assessed for eligibility; 22 were randomised and 18 completed the study requirements']","['placebo', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'Active rTMS', 'Active rTMS intervention and the other half given Sham rTMS', 'rTMS', 'repetitive Transcranial Magnetic Stimulation']","['RPQ13', 'Tolerability and efficacy', 'Rivermead Post-Concussion Symptoms Questionnaire (RPQ3 & RPQ13']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0546983', 'cui_str': 'Post-Concussion Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",37.0,0.386029,"This improvement predominantly manifested in RPQ13 in the follow up periods 1 and 2 months after the intervention (RPQ13 change (mean ± SD): at 1 month, Active = -21.8 ± 6.6, Sham = -2.2 ± 9.8; at 2 months, Active = -21.2 ± 5.3, Sham = -5.4 ± 13.7).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moussavi', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada. Zahra.Moussavi@umanitoba.ca.'}, {'ForeName': 'Abdelbaset', 'Initials': 'A', 'LastName': 'Suleiman', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Rutherford', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Ranjbar Pouya', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dastgheib', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Statistics Department, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Salter', 'Affiliation': 'Riverview Health Centre, Winnipeg, Canada.'}, {'ForeName': 'Xikui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Statistics Department, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mansouri', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lithgow', 'Affiliation': 'Biomedical Engineering, University of Manitoba, Winnipeg, Canada.'}]",Scientific reports,['10.1038/s41598-019-41923-6']
378,32239460,"The effect of individualized, theory-based counselling intervention on active aging and quality of life among older people (the AGNES intervention study).","BACKGROUND


We define active aging as a striving for activities as per one's goals, capacities and opportunities.
AIM


To test the 1-year counselling intervention effects on active aging.
METHODS


In this two-arm single-blinded randomized controlled trial, the intervention group received individually tailored counselling supporting autonomous motivation for active life (one face-to-face session, four phone calls and supportive written material, n = 101) and the control group written health information (n = 103). Participants were community-dwelling men and women aged 75 or 80 years with intermediate mobility function and without cognitive impairment. The primary outcome was active aging total score measured with the University of Jyväskylä Active Aging Scale (UJACAS, range 0-272, higher values indicate more activity) and secondary outcomes were its subscores for goals, ability, opportunity and activity (range 0-68) and a quality of life (QoL) score. Measures took place at pre-trial, mid-trial (6 months) and post-trial (12 months), except for QoL only pre and post-trial. Data were analyzed with intention-to-treat principles using GEE-models.
RESULTS


The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant. A small effect was observed for the activity subscore (p = 0.007).
DISCUSSION


The individualized counselling supporting autonomous motivation for active life increased the UJACAS score slightly.
CONCLUSIONS


It may be possible to promote active aging with individualized counselling, but the effect is small and it is unclear whether the change is meaningful.",2020,"The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant.","['Participants were community-dwelling men and women aged 75 or 80\xa0years with intermediate mobility function and without cognitive impairment', 'older people (the AGNES intervention study']","['individualized, theory-based counselling intervention', 'individually tailored counselling supporting autonomous motivation for active life (one face-to-face session, four phone calls and supportive written material, n\u2009=\u2009101) and the control group written health information']","['active aging and quality of life', 'active aging total score measured with the University of Jyväskylä Active Aging Scale (UJACAS, range 0-272, higher values indicate more activity) and secondary outcomes were its subscores for goals, ability, opportunity and activity (range 0-68) and a quality of life (QoL) score', 'activity subscore', 'UJACAS total score']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.166963,"The UJACAS total score increased in the intervention group slightly more than in the control group (group by time p-value = 0.050, effect size 0.011, net benefit 2%), but the group effect was not statistically significant.","[{'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland. taina.rantanen@jyu.fi.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pynnönen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Siltanen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kokko', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Karavirta', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Kauppinen', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Milla', 'Initials': 'M', 'LastName': 'Saajanaho', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, Finland.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01535-x']
379,32232434,A posture and mobility training package for care home staff: results of a cluster randomised controlled feasibility trial (the PATCH trial).,"BACKGROUND


provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve well-being but are often time-limited and resource intensive. A sustainable approach is to enhance the confidence and skills of staff who provide care. This trial assessed the feasibility of undertaking a definitive evaluation of a posture and mobility training programme for care staff.
DESIGN AND SETTING


a cluster randomised controlled feasibility trial with embedded process evaluation. Ten care homes in Yorkshire, United Kingdom, were randomised (1:1) to the skilful care training package (SCTP) or usual care (UC).
PARTICIPANTS


residents who were not independently mobile.
INTERVENTION


SCTP-delivered by physiotherapists to care staff.
OBJECTIVES AND MEASUREMENTS


key objectives informed progression to a definitive trial. Recruitment, retention and intervention uptake were monitored. Data, collected by a blinded researcher, included pain, posture, mobility, hospitalisations and falls. This informed data collection feasibility and participant safety.
RESULTS


a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP). Forty two were lost by 6 months, largely due to deaths. While data collection from proxy informants was good (>95% expected data), attrition meant that data completion rates did not meet target. Data collection from residents was poor due to high levels of dementia. Intervention uptake was variable-staff attendance at all sessions ranged from 12.5 to 65.8%. There were no safety concerns.
CONCLUSION


care home and resident recruitment are feasible, but refinement of data collection approaches and intervention delivery are needed for this trial and care home research more widely.",2020,"There were no safety concerns.
","['residents who were not independently mobile', 'a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP', 'Ten care homes in Yorkshire, United Kingdom', 'care home staff']","['posture and mobility training package', 'posture and mobility training programme', 'skilful care training package (SCTP) or usual care (UC', 'Physiotherapy and activity interventions']","['pain, posture, mobility, hospitalisations and falls', 'Recruitment, retention and intervention uptake']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",348.0,0.13646,"There were no safety concerns.
","[{'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Graham', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Ellwood', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hull', 'Affiliation': 'Leeds Neurophysiotherapy, Leeds, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Leeds Neurophysiotherapy, Leeds, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Cundill', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holland', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Goodwin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clarke', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hawkins', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Health Economics Group, Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Patel', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.'}]",Age and ageing,['10.1093/ageing/afaa046']
380,32229801,Efficacy and Safety of Etomidate in Comparison with Propofol or Midazolam as Sedative for Upper Gastrointestinal Endoscopy.,"BACKGROUND/AIMS


In this study, we compared the efficacy and safety of etomidate with those of propofol or midazolam for the maintenance of sedation during endoscopy.
METHODS


The study enrolled patients who underwent sedative endoscopy in our hospital and divided them into three groups. Patients in each group were administered midazolam as induction therapy and were subsequently administered either midazolam (M + M group), propofol (M + P group), or etomidate (M + E group) as maintenance medication. The primary outcome was overall cardiovascular and respiratory adverse events.
RESULTS


In total, 105 patients who underwent sedative endoscopic examination were enrolled. The outcomes related to the procedure and sedation were not significantly different among the groups. Overall cardiovascular and respiratory adverse events were observed in 9 patients (25.7%) in the M + M group, 8 patients (23.5%) in the M + P group, and 10 patients (27.8%) in the M + E group. The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
CONCLUSION


The outcomes following the use of etomidate for maintenance after induction with midazolam for sedation in upper gastrointestinal endoscopy were not inferior to those following midazolam or propofol use from the perspectives of safety and efficacy.",2020,"The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
","['105 patients who underwent sedative endoscopic examination were enrolled', 'Upper Gastrointestinal Endoscopy']","['midazolam or propofol', 'Propofol or Midazolam', 'Etomidate', 'midazolam', 'midazolam (M + M group), propofol (M + P group), or etomidate (M + E group) as maintenance medication', 'etomidate', 'sedative endoscopy', 'propofol or midazolam']","['Efficacy and Safety', 'procedure and sedation', 'efficacy and safety', 'overall cardiovascular and respiratory adverse events', 'safety and efficacy', 'Overall cardiovascular and respiratory adverse events']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",105.0,0.0384774,"The logistic regression analysis revealed that etomidate use was not an independent risk factor for overall cardiovascular and respiratory adverse events.
","[{'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sanghwan', 'Initials': 'S', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Youn Jung', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kyoungwon', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Seun Ja', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}]",Clinical endoscopy,['10.5946/ce.2019.210']
381,31201877,To What Extent Do the NRS and CRQ Capture Change in Patients' Experience of Breathlessness in Advanced Disease? Findings From a Mixed-Methods Double-Blind Randomized Feasibility Trial.,"CONTEXT


Chronic or refractory breathlessness is common and distressing. To evaluate new treatments, outcome measures that capture change in patients' experience are needed.
OBJECTIVES


To explore the extent to which the numerical rating scale (NRS) worst and average, and the Chronic Respiratory Questionnaire capture change in patients' experience during a trial of mirtazapine for refractory breathlessness.
METHODS


Convergent mixed-methods design embedded within a randomized trial comprising 1) semi-structured qualitative interviews (considered to be the gold standard) and 2) outcome measure data collected pre- and post-intervention. Data were integrated, exploring examples where findings agreed and disagreed. Adults with advanced cancer, chronic obstructive pulmonary disease, interstitial lung disease, or chronic heart failure, with a modified Medical Research Council dyspnea scale grade 3 or 4 were recruited from three U.K. sites.
RESULTS


Data were collected for 22 participants. Eleven had a diagnosis of chronic obstructive pulmonary disease, eight interstitial lung disease, two chronic heart failure, and one cancer. Median age was 71 (56-84) years. Sixteen participants were men. Changes in the qualitative data were commonly captured in the NRS (worst and average) and the Chronic Respiratory Questionnaire. The NRS worst captured change most frequently. Improvement in the emotional domain was associated with physical changes, improved confidence, and control.
CONCLUSION


This study found that the NRS using the question ""How bad has your breathlessness felt at its worst over the past 24 hours?"" captured change across multiple domains, and therefore may be an appropriate primary outcome measure in trials in this population. Future work should confirm the construct validity of this question.",2019,"Improvement in the emotional domain was associated with physical changes, improved confidence, and control.
","['Adults with advanced cancer, chronic obstructive pulmonary disease, interstitial lung disease, or chronic heart failure, with a modified Medical Research Council dyspnea scale grade 3 or 4 were recruited from three U.K. sites', 'Sixteen participants were men', 'Eleven had a diagnosis of chronic obstructive pulmonary disease, eight interstitial lung disease, two chronic heart failure, and one cancer', 'Median age was 71 (56-84) years']",['mirtazapine'],"['physical changes, improved confidence, and control', 'numerical rating scale (NRS) worst and average, and the Chronic Respiratory Questionnaire capture change', 'Chronic Respiratory Questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0222045'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1.0,0.209365,"Improvement in the emotional domain was associated with physical changes, improved confidence, and control.
","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lovell', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom. Electronic address: Natasha.lovell@kcl.ac.uk.""}, {'ForeName': 'Simon Noah', 'Initials': 'SN', 'LastName': 'Etkind', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maddocks', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Irene Julie', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.06.004']
382,31310575,"Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study.","Rationale:  Continuous positive airway pressure (CPAP) is the standard treatment for the obstructive sleep apnea syndrome (OSAS), but long-term adherence remains a challenge. In a pilot study, we observed that telemedicine combined with telemetrically triggered interventions was associated with improved CPAP adherence in the first month of treatment. Objectives:  In the current randomized, controlled phase III trial, we aimed to collect pivotal data for the use of telemedicine in CPAP treatment of patients with OSAS. Methods:  Symptomatic patients with OSAS were randomized to a telemedicine or control arm and initiated CPAP treatment. Phone calls were triggered in the telemedicine group during the first month of treatment upon either poor use or excessive mask leakage. Patients were followed for 6 months. Measures of CPAP use at 6 months were the main study endpoints. Results:  Among 240 patients enrolled, 71 (30%) discontinued CPAP treatment over the course of the study. The primary outcome measure, the proportion of nights with CPAP use greater than 1 hour, was not statistically different in the telemedicine group (92.0%) versus the control group (88.2%) ( P  = 0.565). The daily hours of CPAP use at 6 months also did not differ significantly between the telemedicine group (5.6 h) and the control group (4.8 h) ( P  = 0.663). However, in a  post hoc  analysis, telemedicine led to increased device use in a subgroup of patients with a mild form of disease (5.6 h vs. 3.4 h;  P  = 0.026). The telemedicine-based intervention had a positive impact on sleep-related quality of life as measured with the Quebec Sleep Questionnaire (5.55 vs. 5.49 at 1 mo [ P  = 0.020]; 5.61 vs. 5.46 at 6 mo [ P  = 0.013]). Conclusions:  A telemetrically triggered intervention in the first month of treatment did not improve CPAP use in the study population overall, but it had positive effects in patients with a mild form of OSAS and led to an improvement in sleep-related quality of life.Clinical trial registered with www.clinicaltrials.gov (NCT01715194).",2019,"The telemedicine-based intervention had a positive impact on sleep-related quality of life, as measured with Quebec Sleep Questionnaire (5.55 versus 5.49 at 1 month, p=0.020; 5.61 vs 5.46 at 6 months, p=0.013).
","['obstructive sleep apnea syndrome (OSAS', 'patients with OSAS', '240 patients enrolled, 71 (30%) discontinued CPAP treatment over the course of the study', 'Symptomatic OSAS patients', 'Sleep Apnea']","['telemedicine or control arm and initiated CPAP treatment', 'telemedicine', 'Continuous positive airway pressure (CPAP', 'Telemedicine', 'telemedicine combined with telemetrically-triggered interventions']","['CPAP usage', 'proportion of nights with CPAP usage ≥1 h', 'CPAP adherence', 'sleep-related quality of life', 'sleep-related quality of life, as measured with Quebec Sleep Questionnaire', 'device usage']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",240.0,0.0847824,"The telemedicine-based intervention had a positive impact on sleep-related quality of life, as measured with Quebec Sleep Questionnaire (5.55 versus 5.49 at 1 month, p=0.020; 5.61 vs 5.46 at 6 months, p=0.013).
","[{'ForeName': 'Otto D', 'Initials': 'OD', 'LastName': 'Schoch', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Baty', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Boesch', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Benz', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Niedermann', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Brutsche', 'Affiliation': 'Center for Sleep Medicine, Department of Pneumology and Sleep Medicine, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201901-013OC']
383,31314549,Methods for the Watch the Spot Trial. A Pragmatic Trial of More- versus Less-Intensive Strategies for Active Surveillance of Small Pulmonary Nodules.,"Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include:  1 ) the pragmatic integration of study procedures into existing clinical workflow;  2 ) the use of cluster randomization by hospital or health system;  3 ) the implementation and evaluation of a system-level intervention for protocol-based care;  4 ) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants;  5 ) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries;  6 ) linkage with state cancer registries for complete ascertainment of the primary study outcome; and  7 ) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study.",2019,"Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care utilization, radiation exposure, and adherence with the assigned surveillance protocol.","['active surveillance of small pulmonary nodules', '35,200 patients with a small pulmonary nodule that is newly detected on chest CT, either incidentally or by screening', 'Active Surveillance of Small Pulmonary Nodules']","['chest computed tomography (CT', 'cluster-randomization by hospital or health system; (3) the implementation and evaluation of a system-level intervention for protocol-based care; (4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; (5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; (6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and (7) intensive engagement with a diverse group of patient and non-patient stakeholders']","['patient-reported anxiety and emotional distress, nodule-related health care utilization, radiation exposure, and adherence with the assigned surveillance protocol', 'percentage of cancerous nodules that progress beyond American Joint Committee on Cancer 7th edition (AJCC 7) stage T1aN0M0']","[{'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0202823', 'cui_str': 'Chest CT'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",,0.105898,"Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care utilization, radiation exposure, and adherence with the assigned surveillance protocol.","[{'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gould', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Smith-Bindman', 'Affiliation': 'Department of Radiology and Biomedical Imaging.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Department of Medicine and.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Altman', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Barjaktarevic', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Creekmur', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'de Bie', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Dyer', 'Affiliation': 'Department of Radiology, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Mortani Barbosa', 'Affiliation': 'Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California.'}, {'ForeName': 'Laszlo T', 'Initials': 'LT', 'LastName': 'Vaszar', 'Affiliation': 'Department of Medicine, Mayo Clinic, Scottsdale, Arizona; and.'}, {'ForeName': 'Sophronia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology and Biomedical Imaging.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Miglioretti', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of California, Davis, Davis, California.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201903-268SD']
384,30915444,Application of blood concentration biomarkers in nutritional epidemiology: example of carotenoid and tocopherol intake in relation to chronic disease risk.,"BACKGROUND


Biomarkers provide potential to objectively measure the intake of nutrients and foods, and thereby to strengthen nutritional epidemiology association studies. However, there are only a few established intake biomarkers, mostly based on recovery of nutrients or their metabolites in urine. Blood concentration measures provide a potential biomarker source for many additional nutritional variables, but their use in disease-association studies requires further development.
OBJECTIVE


The aim of this study was to apply recently proposed serum-based carotenoid and tocopherol intake biomarkers and to examine their association with the incidence of major cardiovascular diseases, cancers, and diabetes in a subset of Women's Health Initiative (WHI) cohorts.
METHODS


Serum concentrations of α- and β-carotene, lutein plus zeaxanthin (L + Z), and α-tocopherol were routinely measured at baseline in a subset of 5488 enrollees in WHI cohorts. Intake biomarkers for these 4 micronutrients, obtained by combining serum concentrations with participant characteristics, were recently proposed using a 153-woman feeding study within WHI. These biomarker equations are augmented here to include pertinent disease risk factors and are associated with subsequent chronic disease incidence in this WHI subset.
RESULTS


HRs for a doubling of micronutrient intake differed only moderately from the null for the outcomes considered. However, somewhat lower risks of specific cardiovascular outcomes, breast cancer, and diabetes were associated with a higher intake of α- and β-carotene, lower risk of diabetes was associated with higher L + Z intake, and elevated risks of certain cardiovascular outcomes were associated with a higher intake of α-tocopherol. These patterns remained following the exclusion of baseline users of dietary supplements.
CONCLUSIONS


Concentration biomarkers can be calculated from blood specimens obtained in large epidemiologic cohorts and applied directly in disease-association analyses, without relying on self-reported dietary data. Observed associations between carotenoid and tocopherol biomarkers and chronic disease risk could be usefully evaluated further using stored serum specimens on the entire WHI cohort. This study was registered at www.clinicaltrials.gov as NCT00000611.",2019,"However, somewhat lower risks of specific cardiovascular outcomes, breast cancer, and diabetes were associated with a higher intake of α- and β-carotene, lower risk of diabetes was associated with higher L + Z intake, and elevated risks of certain cardiovascular outcomes were associated with a higher intake of α-tocopherol.","['nutritional epidemiology', '5488 enrollees in WHI cohorts']",[],"['Serum concentrations of α- and β-carotene, lutein plus zeaxanthin (L\xa0+\xa0Z), and α-tocopherol']","[{'cui': 'C0014507', 'cui_str': 'Epidemiology'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}]",,0.0202928,"However, somewhat lower risks of specific cardiovascular outcomes, breast cancer, and diabetes were associated with a higher intake of α- and β-carotene, lower risk of diabetes was associated with higher L + Z intake, and elevated risks of certain cardiovascular outcomes were associated with a higher intake of α-tocopherol.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pettinger', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Lesley F', 'Initials': 'LF', 'LastName': 'Tinker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Joseph J. Zilber School of Public Health University of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Mossavar-Rahmani', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy360']
385,31750698,The effect of SMS behavior change techniques on event-level desire to get drunk in young adults.,"Text messaging (SMS) interventions incorporating a combination of behavior change techniques can assist reductions in alcohol consumption among young adult hazardous drinkers, but mechanisms of action remain unknown. In this secondary analysis, we test the hypothesis that desire to get drunk (DD) recorded prior to drinking episodes would mediate SMS intervention effects on the likelihood of event-level heavy drinking (4 +/5 + drinks for women/men). We recruited young adult hazardous drinkers to a trial where they were randomized to 1 of 5 SMS interventions: TRACK (self-monitoring of alcohol use), PLAN (feedback on drinking plans and DD), USE (postdrinking feedback on alcohol consumed), GOAL (goal prompts/support), and COMBO (i.e., 4 interventions combined). Up to 3 days per week for 14 weeks, when participants reported a plan to drink, they were asked to report DD on a scale from 0 ( none ) to 8 ( completely ) and next day asked to recall drink quantity. Multilevel structural equation models showed that DD mediated the treatment effect of GOAL on heavy drinking. This work illustrates the importance of goal support features in digital alcohol interventions and the utility of measuring desire to get drunk as a key mediator in alcohol studies. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Text messaging (SMS) interventions incorporating a combination of behavior change techniques can assist reductions in alcohol consumption among young adult hazardous drinkers, but mechanisms of action remain unknown.","['young adults', 'young adult hazardous drinkers']","['Text messaging (SMS) interventions incorporating a combination of behavior change techniques', 'SMS behavior change techniques', '5 SMS interventions: TRACK (self-monitoring of alcohol use), PLAN (feedback on drinking plans and DD), USE (postdrinking feedback on alcohol consumed), GOAL (goal prompts/support), and COMBO']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],2019.0,0.0352323,"Text messaging (SMS) interventions incorporating a combination of behavior change techniques can assist reductions in alcohol consumption among young adult hazardous drinkers, but mechanisms of action remain unknown.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kirisci', 'Affiliation': 'Department of Pharmaceutical Sciences.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000534']
386,31152783,"Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks.","CONTEXT


Pain is one of the most prevalent symptoms associated with cancer. Strong opioids are commonly used in the analgesic management of the disease, but carry the risk of severe side effects. Cebranopadol is a first-in-class drug candidate, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. For cancer patients, frequently experiencing multimorbidities and often exposed to polypharmacy, cebranopadol is easy to handle given its once-daily dosing, the small tablet size that enables swallowing, and the option to flexibly titrate to an effective dose.
OBJECTIVES


We assessed the safety and tolerability of prolonged treatment with oral cebranopadol for up to 26 weeks in patients suffering from chronic moderate-to-severe cancer-related pain.
METHODS


This was a non-randomized, multi-site, open-label, single-arm clinical trial with patients who had completed a double-blind trial comparing morphine prolonged release with cebranopadol. In this extension trial, patients were treated with oral cebranopadol for up to 26 weeks.
RESULTS


Cebranopadol was safe and well tolerated in patients with chronic moderate-to-severe pain related to cancer in the dose range tested (200-1000 μg once daily). The median and mean pain levels remained in the range of mild pain during the treatment period.
CONCLUSION


Our data suggest that cebranopadol was safe and well tolerated when administered for up to 26 weeks in patients with chronic cancer-related pain who were previously treated with cebranopadol or morphine prolonged release.",2019,"RESULTS


Cebranopadol was safe and well tolerated in patients with chronic moderate to severe pain related to cancer in the dose range tested (200 to 1,000 μg once daily).","['patients with chronic cancer-related pain who were previously treated with', 'patients suffering from chronic moderate to severe cancer-related pain', 'patients with chronic moderate to severe pain', 'For cancer patients']","['morphine prolonged release (PR) with cebranopadol', 'cebranopadol', 'oral cebranopadol', 'cebranopadol or morphine PR', 'Cebranopadol']","['Pain', 'median and mean pain levels', 'safe and well tolerated', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4544056', 'cui_str': 'Chronic pain due to malignant neoplastic disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C3827125'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.12427,"RESULTS


Cebranopadol was safe and well tolerated in patients with chronic moderate to severe pain related to cancer in the dose range tested (200 to 1,000 μg once daily).","[{'ForeName': 'E Dietlind', 'Initials': 'ED', 'LastName': 'Koch', 'Affiliation': 'Innovation Unit Pain, Clinical Science, Grünenthal GmbH, Aachen, Germany. Electronic address: dietlind.koch@grunenthal.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Kapanadze', 'Affiliation': 'Innovation Unit Pain, Clinical Science, Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Marie-Henriette', 'Initials': 'MH', 'LastName': 'Eerdekens', 'Affiliation': 'Innovation Unit Pain, Clinical Science, Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kralidis', 'Affiliation': 'Data Sciences-Statistics, Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Létal', 'Affiliation': 'Data Sciences-Statistics, Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Sabatschus', 'Affiliation': 'Global Drug Safety, Grünenthal GmbH, Aachen, Germany.'}, {'ForeName': 'Sam H', 'Initials': 'SH', 'LastName': 'Ahmedzai', 'Affiliation': 'Department of Oncology, University of Sheffield, Sheffield, UK.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.05.012']
387,31163259,"Usability of PCforMe in Patients With Advanced Cancer Referred to Outpatient Palliative Care: Results of a Randomized, Active-Controlled Pilot Trial.","CONTEXT


Low utilization of palliative care services warrant testing of new solutions to educate and engage patients around the benefits of palliative care.
OBJECTIVES


We sought out to develop and test a novel, mobile health solution to prepare patients for an upcoming outpatient palliative care appointment.
METHODS


After developing a web-based tool called PCforMe (Palliative Care for Me), we conducted a randomized, active-controlled, trial of PCforMe. The primary outcome was the score on the System Usability Scale (SUS). Secondary outcomes were patient self-efficacy and change in knowledge. We compared PCforMe to three common online resources for patients seeking information about palliative care.
RESULTS


A total of 80 patients were randomized. There were no significant demographic differences. Mean SUS score for PCforMe was 78.2, significantly above the normative average SUS score of 68 (P-value < 0.0001). Mean change in Perceived Efficacy in Patient-Physician Interactions score was -2.2 for PCforMe and -1.7 for control group (P-value = 0.72). Preparedness for an upcoming palliative care visit increased 50% in the intervention group and 13.3% in the control group. Difference in the number of patients with improved knowledge regarding palliative care approached significance (P = 0.06). Lastly, we found that the no-show rate was lower during Q1 2017 (during trial) and Q1 2016 (before trial), at 11.7% and 21%, respectively (P < 0.05). Comparing the full calendar year (CY) 2016 with 2017, we did not find a statistical difference (CY 2016 of 18.8% and 15% in CY 2017; P = 0.22).
CONCLUSION


PCforMe is a usable mobile health tool to prepare patients for an upcoming palliative care appointment. Further research is needed to test effectiveness.",2019,Preparedness for an upcoming palliative care visit increased 50% in the intervention group versus 13.3% in the control group.,"['80 patients were randomized', 'patients seeking information about specialty palliative care', 'patients with advanced cancer referred to outpatient palliative care']",['PCforMe'],"['Mean SUS score for PCforMe', 'patient self-efficacy (measured by PEPPI) and change in knowledge (measured by a questionnaire', 'score on the System Usability Scale (SUS', 'Mean change in PEPPI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0222045'}]",80.0,0.162866,Preparedness for an upcoming palliative care visit increased 50% in the intervention group versus 13.3% in the control group.,"[{'ForeName': 'Arif H', 'Initials': 'AH', 'LastName': 'Kamal', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina, USA; Duke Fuqua School of Business, Durham, North Carolina, USA; Department of Population Health Sciences, Duke University, Durham, North Carolina, USA. Electronic address: arif.kamal@duke.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Nicolla', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Friedman', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Xuan', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Bennett', 'Affiliation': 'Department of Health Policy and Management, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Samsa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.05.007']
388,30932012,The Influence of Energy Depletion by Metformin or Hypocaloric Diet on Thyroid Iodine Uptake in Healthy Volunteers: a Randomized Trial.,"Sufficient thyroid iodine uptake is needed to ensure effective radioactive iodine (RAI) treatment, which is mediated by the sodium-iodide symporter (NIS). Activation of AMP-activated-protein-kinase (AMPK), leads to decreased NIS expression and thyroid iodine uptake in in vitro and animal models. Clinically relevant conditions that lead to AMPK activation include metformin use and hypocaloric conditions. Here, we aim to assess the effects of metformin and hypocaloric diet on thyroid iodine uptake in healthy volunteers. Healthy male volunteers were included and randomized. Group 1 (n = 8) received metformin, group 2 (n = 7) followed a hypocaloric diet (1500 kcal/day), superposed on a moderate iodine restriction diet; Baseline measurements included thyroid iodine-123 (I-123) uptake and TSH, fT4, T3 and rT3 levels. After two weeks, thyroid function and I-123 uptake measurements were repeated. Baseline characteristics were similar between groups. Levels of TSH and fT4 were similar after each intervention. T3 decreased after hypocaloric diet and metformin (-0.2 ± 0.19 nmol/L, p = 0.0327; respectively -0.13 ± 0.13 nmol/L, p = 0.0282), resulting in decreased T3/rT3 ratios. There was no significant difference in thyroid I-123 uptake after each intervention. In conclusion, metformin treatment and hypocaloric diet resulted in a significant decrease in T3 levels and T3/rT3 ratios in healthy volunteers, without significant effects on thyroid iodine uptake. We found no indications that metformin or hypocaloric diet will have clinically relevant effects on RAI uptake.",2019,There was no significant difference in thyroid I-123 uptake after each intervention.,"['Healthy male volunteers', 'Healthy Volunteers', 'healthy volunteers']","['hypocaloric diet', 'Metformin or Hypocaloric Diet', 'metformin', 'hypocaloric diet and metformin', 'metformin and hypocaloric diet', 'AMP-activated-protein-kinase (AMPK']","['thyroid iodine-123 (I-123) uptake and TSH, fT4, T3 and rT3 levels', 'thyroid I-123 uptake', 'NIS expression and thyroid iodine uptake', 'thyroid iodine uptake', 'Thyroid Iodine Uptake', 'T3 levels and T3/rT3 ratios', 'thyroid function and I-123 uptake measurements', 'RAI uptake', 'Levels of TSH and fT4']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2350345', 'cui_str': ""5'-AMP-Activated Protein Kinase""}]","[{'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C3495673', 'cui_str': 'IODIDE ION I-123'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0302241', 'cui_str': 'Thyroid iodine uptake, function (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0201807', 'cui_str': 'Uptake measurement (procedure)'}]",,0.0264782,There was no significant difference in thyroid I-123 uptake after each intervention.,"[{'ForeName': 'Yvette J E', 'Initials': 'YJE', 'LastName': 'Sloot', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA, Nijmegen, The Netherlands. yvette.sloot@radboudumc.nl.'}, {'ForeName': 'Marcel J R', 'Initials': 'MJR', 'LastName': 'Janssen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Antonius E', 'Initials': 'AE', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Peeters', 'Affiliation': 'Department of Internal Medicine, Academic centre for Thyroid Diseases, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Romana T', 'Initials': 'RT', 'LastName': 'Netea-Maier', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Radboud University Medical Center, Geert Grooteplein Zuid 8, 6525 GA, Nijmegen, The Netherlands. Jan.Smit@radboudumc.nl.'}]",Scientific reports,['10.1038/s41598-019-41997-2']
389,31437008,A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing.,"Rationale:  Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using nonphysician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and did not directly explore the impacts of a model incorporating ACPs on healthcare system performance, such as wait times. Objectives:  To evaluate the use of ACPs in the management of patients with severe SDB from a clinical and system perspective. Methods:  In this noninferiority study, patients with severe SDB ( N  = 156) were enrolled from October 2014 to July 2016 and randomized to either sleep physician management or management by ACP with same-day sleep physician review. Severe SDB was defined as one of  1 ) respiratory event index greater than 30/h,  2 ) mean nocturnal oxygen saturation less than 85%, and  3 ) arterial carbon dioxide greater than 45 mm Hg with respiratory event index greater than 15/h. The primary outcome was nightly positive airway pressure adherence at 3 months, using a noninferiority margin of 1 hour. Secondary outcomes included sleepiness, quality of life, patient satisfaction, wait times for diagnosis and treatment initiation, and demand for further testing and clinical assessment. Outcomes were evaluated using modified intention-to-treat and per-protocol analyses. Results:  Care delivery using ACPs was indeterminate compared with sleep physician care with respect to treatment adherence, because the 95% confidence interval included the noninferiority margin of 1 hour (mean difference, -0.5 [-1.49 to 0.49] h). Patients in the ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%). There was no difference in demand for sleep testing or clinical follow-up. Per-protocol analysis revealed similar results. Conclusions:  Management of severe SDB using ACPs was indeterminate compared with sleep physician care. The small decrease in adherence in the ACP arm was balanced by benefits in patient-reported outcomes and reduction in wait times. In systems with unacceptably long wait times for SDB diagnosis and treatment, a small decrease in treatment adherence, as was observed in this study, may be an acceptable trade-off to improve access to care for patients with severe SDB.Clinical trial registered with www.clinicaltrials.gov (NCT02191085).",2019,Patients in ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%).,"['patients with severe SDB from a clinical and system perspective', 'patients with severe SDB', 'patients with severe SDB (n=156) were enrolled from October 2014 to July 2016 and randomized to either']","['Alternative Care Provider Clinic', 'sleep physician management or management by ACP with same-day sleep physician review', 'ACPs', 'ACP', 'sleep-disordered breathing (SDB']","['sleepiness; quality of life; patient satisfaction; wait times for diagnosis and treatment initiation; and demand for further testing and clinical assessment', 'arterial carbon dioxide >45mmHg with REI', 'nightly positive airway pressure adherence', 'sleepiness and quality of life; wait times', 'adherence', 'Severe Sleep-disordered Breathing', 'Severe SDB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]",,0.109426,Patients in ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%).,"[{'ForeName': 'Sachin R', 'Initials': 'SR', 'LastName': 'Pendharkar', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Willis H', 'Initials': 'WH', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Penz', 'Affiliation': 'Department of Medicine, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Santana', 'Affiliation': 'Department of Community Health Sciences.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Ip-Buting', 'Affiliation': 'W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; and.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; and.'}, {'ForeName': 'W Ward', 'Initials': 'WW', 'LastName': 'Flemons', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Fraser', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hanly', 'Affiliation': 'Department of Medicine.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201901-087OC']
390,31128228,Association Between Plasma Brain Natriuretic Peptide and Overall Survival in Patients With Advanced Cancer: Preliminary Findings.,"CONTEXT


Atrial and brain natriuretic peptides (ANP and BNP) are established diagnostic and prognostic markers in heart failure, but their utility in patients with advanced cancer is unclear.
OBJECTIVES


Our objective was to examine the association between plasma natriuretic peptides and survival in patients with advanced cancer without clinical evidence of heart failure.
METHODS


This exploratory analysis of a multicenter, randomized clinical trial of cancer patients receiving hospice care assessed the association between elevated plasma ANP, BNP, or Pro-BNP (cutoffs of >77, 100, and 900 pg/mL, respectively) and overall survival. Time-to-event analyses, including multivariate Cox regression, were conducted.
RESULTS


Among 97 patients, the mean age was 67.2 years and the overall survival was 16 days (95% CI, 13-23 days). ANP, BNP, and Pro-BNP were elevated in 29 of 36 (81%), nine of 23 (39%), and 32 of 38 (84%) patients, respectively. Elevated ANP, BNP, or Pro-BNP was associated with worse survival (median 14 vs. 21 days; P = 0.02). BNP or Pro-BNP was inversely associated with overall survival (hazard ratio = 2.27; 95% CI, 1.29-3.97) in univariate Cox regression analysis, and remained significant in multivariate Cox regression analysis (hazard ratio = 3.09; 95% CI, 1.40-6.84) after adjusting for treatment group and known prognostic variables such as performance status, albumin, creatinine, delirium, dyspnea, and anorexia. Elevated ANP alone was not significantly associated with survival (P = 0.17).
CONCLUSION


Our preliminary findings suggest that BNP or Pro-BNP may be a novel objective prognostic marker in cancer patients without heart failure. Further research is needed to confirm these findings.",2019,"ANP, BNP, and Pro-BNP were elevated in 29 of 36 (81%), nine of 23 (39%), and 32 of 38 (84%) patients, respectively.","['cancer patients receiving hospice care', '97 patients, the mean age was 67.2\xa0years and the', 'patients with advanced cancer without clinical evidence of heart failure', 'patients with advanced cancer', 'cancer patients without heart failure', 'Patients With Advanced Cancer']",['BNP or Pro-BNP'],"['elevated plasma ANP, BNP, or Pro-BNP', 'BNP or Pro-BNP', 'survival', 'worse survival', 'ANP, BNP, and Pro-BNP', 'performance status, albumin, creatinine, delirium, dyspnea, and anorexia', 'overall survival', 'Elevated ANP, BNP, or Pro-BNP']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.313953,"ANP, BNP, and Pro-BNP were elevated in 29 of 36 (81%), nine of 23 (39%), and 32 of 38 (84%) patients, respectively.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Naberhuis', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Seyedeh', 'Initials': 'S', 'LastName': 'Dibaj', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Naqvi', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.05.006']
391,32147182,"Ultralong administration of gonadotropin-releasing hormone agonists before in vitro fertilization improves fertilization rate but not clinical pregnancy rate in women with mild endometriosis: a prospective, randomized, controlled trial.","OBJECTIVE


To evaluate the effects of gonadotropin-releasing hormone agonists (GnRH-a) on fertility in women with mild endometriosis who are undergoing in vitro fertilization and embryo transfer (IVF-ET) procedures.
DESIGN


Prospective, randomized, controlled trial.
SETTING


Three tertiary university hospitals.
PATIENT(S)


Four hundred infertile women with mild endometriosis, documented with laparoscopy, undergoing IVF and 200 women with tubal factor infertility.
INTERVENTION(S)


Administration of GnRH-a for 3 months before an IVF attempt (group A, n = 200) or IVF without GnRH-a (group B, n = 200).
MAIN OUTCOME MEASURE(S)


Follicular fluid (FF) levels of tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8, and IL-1 receptor antagonist; fertilization rate (FR), implantation rate (IR), quality of embryos, and clinical pregnancy rate (PR).
RESULT(S)


Women who received GnRH-a had a statistically significantly reduced concentration of FF cytokines compared with women who did not receive this regimen. Women in group B had a reduced FR (61.7; 95% CI, 59.20-64.20) compared with the women in group A (72.7; 95% CI, 70.50-74.90) and compared with the women with tubal factor infertility (74.7; 95% CI, 72.00-77.24). The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines. These women had also a higher FR than the women who did not receive GnRH-a. However, the IR, embryo quality, and clinical PR showed no statistically significant difference when comparing the two groups. CLINICALTRIALS.
GOV ID


NCT01269125.",2020,"The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines.","['Three tertiary university hospitals', 'women with mild endometriosis who are undergoing in\xa0vitro fertilization and embryo transfer (IVF-ET) procedures', 'Four hundred infertile women with mild endometriosis, documented with laparoscopy, undergoing IVF and 200 women with tubal factor infertility', 'women with mild endometriosis']","['gonadotropin-releasing hormone agonists (GnRH-a', 'IVF without GnRH-a', 'gonadotropin-releasing hormone agonists']","['embryo quality, IR, and clinical PR', 'fertilization rate', 'reduced FR', 'IR, embryo quality, and clinical PR', 'Follicular fluid (FF) levels of tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8, and IL-1 receptor antagonist; fertilization rate (FR), implantation rate (IR), quality of embryos, and clinical pregnancy rate (PR', 'concentration of FF cytokines', 'tubal factor infertility']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]",400.0,0.41086,"The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines.","[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Kaponis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece. Electronic address: kaponisapostolos@hotmail.com.'}, {'ForeName': 'Grigoris', 'Initials': 'G', 'LastName': 'Chatzopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Minas', 'Initials': 'M', 'LastName': 'Paschopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Georgiou', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Vaggelis', 'Initials': 'V', 'LastName': 'Paraskevaidis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zikopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsiveriotis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Tottori University, Yonago, Japan.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Adonakis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Tottori University, Yonago, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.12.018']
392,31865790,Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial.,"The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy (<140 mm Hg). Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk. Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke. Postrandomization exclusions included participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics. The outcome was incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics. The secondary outcome was impaired fasting glucose (100-125 mg/dL [5.55-6.94 mmol/L]) among those with normoglycemia (<100 mg/dL [5.55 mmol/L]). There were 9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies. There were 299 incident diabetes mellitus events (2.3% per year) for intensive and 251 events (1.9% per year) for standard, rates of 22.6 (20.2-25.3) versus 19.0 (16.8-21.5) events per 1000 person-years of treatment, respectively (adjusted hazard ratio, 1.19 [95% CI, 0.95-1.49]). Impaired fasting glucose rates were 26.4 (24.9-28.0) and 22.5 (21.1-24.1) per 100 person-years for intensive and standard strategies (adjusted hazard ratio, 1.17 [1.06-1.30]). Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose. The risks and benefits of intensive blood pressure targets should be factored into individualized patient treatment goals. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2020,Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose.,"['9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies', 'Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke', 'participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics', 'Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk']","['intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy', 'dL']","['impaired fasting glucose', 'diabetes mellitus', 'Impaired fasting glucose rates', 'diabetes mellitus events', 'cardiovascular outcomes', 'Blood Pressure Control and the Association With Diabetes', 'Mellitus Incidence', 'incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022680', 'cui_str': 'Polycystic Renal Disease'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]",299.0,0.215879,Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose.,"[{'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'From the VA Tennessee Valley Healthcare System Geriatric Research and Education Clinical Center, Nashville, TN (C.L.R., A.M.H.).'}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Hung', 'Affiliation': 'From the VA Tennessee Valley Healthcare System Geriatric Research and Education Clinical Center, Nashville, TN (C.L.R., A.M.H.).'}, {'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, NC (G.B.R.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Ralph H Johnson VA Medical Center and Medical University of South Carolina, Charleston (J.B.).'}, {'ForeName': 'Kathryn Evans', 'Initials': 'KE', 'LastName': 'Kreider', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Department of Medicine, Duke University School of Nursing, Duke University Medical Center, NC (K.E.K.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nord', 'Affiliation': 'Salt Lake City VA Medical Center, Salt Lake City, UT (J.N.).'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Ramsey', 'Affiliation': 'School of Nursing Office of Research and Scholarship, The University of Alabama at Birmingham (T.M.R.).'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, Department of Medicine David Geffen School of Medicine UCLA, Los Angeles, CA (A.R.).'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Sweeney', 'Affiliation': 'Division of Endocrinology, Diabetes and Lipids, Department of Medicine, Emory University and Atlanta VA Medical Center (M.E.S.).'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'Miami Veterans Healthcare and Division of Population Health and Computational Medicine, University of Miami, FL (L.T.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'The Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.).'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': 'Endocrine Unit, VA Boston Healthcare System, Jamaica Plain, MA (J.S.W.).'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Zias', 'Affiliation': 'Northport Veterans Affairs Medical Center, Northport, NY Renaissance School of Medicine at Stony Brook University (A.Z.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center and University of Tennessee Health Science Center, Memphis (W.C.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.118.12572']
393,32149711,Precourse Preparation Using a Serious Smartphone Game on Advanced Life Support Knowledge and Skills: Randomized Controlled Trial.,"BACKGROUND


In the past several years, gamified learning has been growing in popularity in various medical educational contexts including cardiopulmonary resuscitation (CPR) training. Furthermore, prior work in Basic Life Support (BLS) training has demonstrated the benefits of serious games as a method for pretraining among medical students. However, there is little evidence to support these benefits with regard to Advanced Life Support (ALS) training.
OBJECTIVE


We compare the effects of a brief precourse ALS preparation using a serious smartphone game on student knowledge, skills, and perceptions in this area with those of conventional ALS training alone.
METHODS


A serious game (Resus Days) was developed by a Thai physician based on global ALS clinical practice guidelines. Fifth-year medical students were enrolled and randomized to either the game group or the control group. Participants in both groups attended a traditional ALS lecture, but the game group was assigned to play Resus Days for 1 hour before attending the lecture and were allowed to play as much as they wished during the training course. All students underwent conventional ALS training, and their abilities were evaluated using multiple-choice questions and with hands-on practice on a mannequin. Subject attitudes and perceptions about the game were evaluated using a questionnaire.
RESULTS


A total of 105 students participated in the study and were randomly assigned to either the game group (n=52) or the control group (n=53). Students in the game group performed better on the ALS algorithm knowledge posttest than those in the control group (17.22 [SD 1.93] vs 16.60 [SD 1.97], P=.01; adjusted mean difference [AMD] 0.93; 95% CI 0.21-1.66). The game group's pass rate on the skill test was also higher but not to a statistically significant extent (79% vs 66%, P=.09; adjusted odds ratio [AOR] 2.22; 95% CI 0.89-5.51). Students indicated high satisfaction with the game (9.02 [SD 1.11] out of 10).
CONCLUSIONS


Engaging in game-based preparation prior to an ALS training course resulted in better algorithm knowledge scores for medical students than attending the course alone.
TRIAL REGISTRATION


Thai Clinical Trials Registry HE611533; https://tinyurl.com/wmbp3q7.",2020,"Students in the game group performed better on the ALS algorithm knowledge posttest than those in the control group (17.22 [SD 1.93] vs 16.60 [SD 1.97], P=.01; adjusted mean difference [AMD] 0.93; 95% CI 0.21-1.66).","['A total of 105 students participated in the study and were randomly assigned to either the game group (n=52) or the control group (n=53', 'Fifth-year medical students']","['conventional ALS training', 'brief precourse ALS preparation', 'conventional ALS training alone', 'Serious Smartphone Game']","['algorithm knowledge scores', 'ALS algorithm knowledge posttest', 'student knowledge, skills, and perceptions', 'pass rate on the skill test']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0002045'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",105.0,0.0466122,"Students in the game group performed better on the ALS algorithm knowledge posttest than those in the control group (17.22 [SD 1.93] vs 16.60 [SD 1.97], P=.01; adjusted mean difference [AMD] 0.93; 95% CI 0.21-1.66).","[{'ForeName': 'Pariwat', 'Initials': 'P', 'LastName': 'Phungoen', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Songwoot', 'Initials': 'S', 'LastName': 'Promto', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sivit', 'Initials': 'S', 'LastName': 'Chanthawatthanarak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sawitree', 'Initials': 'S', 'LastName': 'Maneepong', 'Affiliation': 'CPR Training Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Korakot', 'Initials': 'K', 'LastName': 'Apiratwarakul', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Praew', 'Initials': 'P', 'LastName': 'Kotruchin', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thapanawong', 'Initials': 'T', 'LastName': 'Mitsungnern', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",Journal of medical Internet research,['10.2196/16987']
394,31964164,Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.,"OBJECTIVE


To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data.
DESIGN


Economic evaluation alongside a randomized controlled trial with two-year follow-up.
SETTING


Patients from the outpatient clinics of a university hospital and a general hospital.
SUBJECTS


A total of 82 lumbar spinal fusion patients.
INTERVENTIONS


Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation.
MAIN MEASURES


Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects.
RESULTS


No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion.
CONCLUSION


This case manager-assisted rehabilitation programme was unlikely to be cost-effective.",2020,No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed.,"['A total of 82 lumbar spinal fusion patients', 'lumbar spinal fusion patients', 'Patients from the outpatient clinics of a university hospital and a general hospital']","['Case manager-assisted rehabilitation', 'case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation', 'case manager-assisted rehabilitation']","['Costs and effects', 'Oswestry Disability Index and EuroQol 5-dimension', 'Oswestry Disability Index or estimate quality-adjusted life years']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.0743614,No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed.,"[{'ForeName': 'Lisa Gregersen', 'Initials': 'LG', 'LastName': 'Oestergaard', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Finn Bjarke', 'Initials': 'FB', 'LastName': 'Christensen', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Claus Vinther', 'Initials': 'CV', 'LastName': 'Nielsen', 'Affiliation': 'Section of Social Medicine and Rehabilitation, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Cody Eric', 'Initials': 'CE', 'LastName': 'Bünger', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Holm', 'Affiliation': 'Orthopedic Department, Region Hospital of Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Helmig', 'Affiliation': 'Department of Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Søgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215519897096']
395,32224119,Effectiveness of Manual and Electrical Acupuncture for Chronic Non-specific Low Back Pain: A Randomized Controlled Trial.,"BACKGROUND


Low back pain is a common condition that can be effectively treated by acupuncture. However, several treatment point prescriptions and further electrical needle stimulation (i.e., local acupoints, distal acupoints, and sensitized acupoints) may be used. There is an implicit yet unexplored assumption about the evidence on manual and electrical stimulation techniques.
OBJECTIVE


The present study aims to identify effectiveness of electroacupuncture (EA) and manual acupuncture (MA) on pain and disability in patients with chronic nonspecific low back.
METHODS


This study is a randomized controlled clinical trial. Sixty-six patients between 20 and 60 years of age with non-specific chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥3 points on a 10 numerical analogic scale. Patients diagnosed with chronic LBP were assigned to receive either 12 sessions of MA or EA. The primary outcomes measurements were pain intensity on Numeric Rating Scale and disability by Roland Morris Disability Questionnaire.
RESULTS


The participants reported improvements post-treatment to pain intensity and disability respectively; however, no differences between groups were observed. Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1). The results were maintained after 3 months of follow-up.
CONCLUSION


The study provides evidence that EA is not superior to MA treatment. Both therapies had similar efficacy in reducing pain and disability for chronic nonspecific low back pain.",2020,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","['chronic nonspecific low back pain', 'patients with chronic low back', '66 randomly allocated patients diagnosed with chronic LBP']","['manual and electrical needle stimulation', 'electroacupuncture (EA) and manual acupuncture (MA', 'acupuncture or electr LINK Word', 'acupuncture', 'electroacupuncture']","['intensity pain and disability', 'intensity pain (NRS) and disability (RMQ', 'pain and disability', 'kinesiophobia']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",66.0,0.286124,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","[{'ForeName': 'Josielli', 'Initials': 'J', 'LastName': 'Comachio', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: josiecomachio@gmail.com.'}, {'ForeName': 'Carla C', 'Initials': 'CC', 'LastName': 'Oliveira', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ilton F R', 'Initials': 'IFR', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mauricio O', 'Initials': 'MO', 'LastName': 'Magalhães', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil; Physical Therapy, Speech and Occupational Therapy Department, University of Para, Belem, Brazil.'}, {'ForeName': 'Amélia P', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.064']
396,31918574,"Effects of kinesiotaping and exercise program on patients with obesity-induced coccydynia: a randomized, double-blinded, sham-controlled clinical trial.","OBJECTIVE


To investigate the effect of kinesiotaping and a designed exercise program versus sham kinesiotaping and the same exercise program on pain, range of motion, and activities of daily living in obese patients suffering from coccydynia.
DESIGN


A double-blinded, randomized, sham-controlled trial.
SETTING


Outpatient, Cairo University hospitals.
PARTICIPANTS


Sixty patients with coccydynia randomized equally into kinesiotape plus exercise and sham kinesiotape plus exercise groups.
INTERVENTION


The kinesiotape was worn for three days and replaced for three weeks. Each patient practiced exercises for three weeks.
OUTCOME MEASURES


All patients were examined by visual analogue scale (VAS) for rating pain, Modified Modified Schober Test (MMST), and Oswestry Disability Index (ODI). All outcomes were measured at baseline, three weeks postintervention, and four weeks follow-up.
RESULTS


There were no statistically significant differences between groups at baseline ( P  < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P  < 0.001). For the three weeks postintervention, mean (SD) for pain score, MMST, and ODI was 33.07 ± 3.8, 6.6 ± 0.7, and 8.7 ± 2.1 in the study group and 39.9 ± 4.7, 5.8 ± 1.4, and 14.4 ± 2.7 in the control group, respectively. For the four weeks follow-up, mean (SD) for pain score, MMST, and ODI was 32.2 ± 3.4, 7.13 ± 0.6, and 7.2 ± 1.8 in the study group and 40.9 ± 4.4, 6.6 ± 0.75, and 13 ± 2 in the control group, respectively.
CONCLUSION


Experimental kinesiotape intervention and exercise program provided significant improvements in pain, range of motion, and disability. It is suggested as an adjunctive therapy in treating obese patients with coccydynia.",2020,"There were no statistically significant differences between groups at baseline ( P  < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P  < 0.001).","['patients with obesity-induced coccydynia', 'Sixty patients with coccydynia randomized equally into', 'obese patients suffering from coccydynia', 'obese patients with coccydynia', 'Outpatient, Cairo University hospitals']","['kinesiotaping and a designed exercise program versus sham kinesiotaping and the same exercise program', 'kinesiotape plus exercise and sham kinesiotape plus exercise groups', 'kinesiotaping and exercise program', 'Experimental kinesiotape intervention and exercise program']","['pain, range of motion, and activities of daily living', 'mean (SD) for pain score, MMST, and ODI', 'pain score, MMST, and ODI', 'visual analogue scale (VAS) for rating pain, Modified Modified Schober Test (MMST), and Oswestry Disability Index (ODI', 'pain, range of motion, and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009193', 'cui_str': 'Pain in the coccyx (finding)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test (procedure)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",60.0,0.514014,"There were no statistically significant differences between groups at baseline ( P  < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P  < 0.001).","[{'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Hany Mohamed', 'Initials': 'HM', 'LastName': 'Elgohary', 'Affiliation': 'Department of physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Elsadat Saad', 'Initials': 'ES', 'LastName': 'Soliman', 'Affiliation': 'Department of Physical Therapy for Musculoskeletal Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Intsar Salem', 'Initials': 'IS', 'LastName': 'Waked', 'Affiliation': 'Department of physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Clinical rehabilitation,['10.1177/0269215519897414']
397,31994405,Effects of cycle ergometer use in early mobilization following cardiac surgery: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of early use of a cycle ergometer, compared to a standard care protocol, in postoperatory in-hospital mobility following cardiac surgery.
DESIGN


A randomized controlled trial.
SETTING


Tertiary hospital in Salvador, Bahia, Brazil.
SUBJECTS


Patients submitted to elective cardiac surgery (valvular or coronary bypass surgery by sternotomy).
INTERVENTION


Patients were randomly allocated in two groups: (1) cycle ergometer training group (10-minute session) and (2) control group submitted standard physiotherapy protocol (10-minute session). Training was provided twice a day, immediately following extubation and until patient was discharged from the intensive care.
MAIN MEASURES


The primary outcome was the difference in the total number of steps recorded on the pedometer over three days. Secondary outcomes were mobility in different subgroups and the reasons that prevented individuals from walking during early cardiac rehabilitation.
RESULTS


A total of 228 participants completed the study. No significant difference was found in the total number of steps between the groups after intervention: 2183 (range: 1729-2772) in the intervention group versus 2006 (1517-2657) in the control group ( P  = 0.167). However, self-reports indicated better motivation in the intervention group ( P  = 0.044). No adverse events occurred during the study.
CONCLUSION


As a strategy for early mobilization following cardiac surgery, the use of a cycle ergometer failed to increase independent physical activity compared to a standard care protocol. Nevertheless, it was safe and could be an alternative to make rehabilitation more attractive and motivational for this patient population.",2020,No significant difference was found in the total number of steps between the groups after intervention:,"['228 participants completed the study', 'early mobilization following cardiac surgery', 'Patients submitted to elective cardiac surgery (valvular or coronary bypass surgery by sternotomy', 'Tertiary hospital in Salvador, Bahia, Brazil']","['cycle ergometer', 'cycle ergometer training group (10-minute session) and (2) control group submitted standard physiotherapy protocol']","['adverse events', 'total number of steps', 'physical activity', 'mobility in different subgroups and the reasons that prevented individuals from walking during early cardiac rehabilitation']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0331315', 'cui_str': 'Bahia (organism)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]",228.0,0.12597,No significant difference was found in the total number of steps between the groups after intervention:,"[{'ForeName': 'Gleide Glícia', 'Initials': 'GG', 'LastName': 'Gama Lordello', 'Affiliation': 'Bahiana School of Medicine and Public Health, Salvador, Brazil.'}, {'ForeName': 'Glicia Gleide', 'Initials': 'GG', 'LastName': 'Gonçalves Gama', 'Affiliation': 'Bahiana School of Medicine and Public Health, Salvador, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Lago Rosier', 'Affiliation': 'Hospital Santa Izabel, Santa Casa da Bahia, Salvador, Brazil.'}, {'ForeName': 'Patrícia Alcântara Doval de Carvalho', 'Initials': 'PADC', 'LastName': 'Viana', 'Affiliation': 'Bahiana School of Medicine and Public Health, Salvador, Brazil.'}, {'ForeName': 'Luís Cláudio', 'Initials': 'LC', 'LastName': 'Correia', 'Affiliation': 'Bahiana School of Medicine and Public Health, Salvador, Brazil.'}, {'ForeName': 'Luiz Eduardo', 'Initials': 'LE', 'LastName': 'Fonteles Ritt', 'Affiliation': 'Bahiana School of Medicine and Public Health, Salvador, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520901763']
398,31937123,The impact of a patient-directed activity program on functional outcomes and activity participation after stroke during inpatient rehabilitation-a randomized controlled trial.,"OBJECTIVE


Individuals post stroke are inactive, even during rehabilitation, contributing to ongoing disability and risk of secondary health conditions. Our aims were to (1) conduct a randomized controlled trial to examine the efficacy of a ""Patient-Directed Activity Program"" on functional outcomes in people post stroke during inpatient rehabilitation and (2) examine differences three months post inpatient rehabilitation discharge.
DESIGN


Randomized control trial.
SETTING


Inpatient rehabilitation facility.
SUBJECTS


Patients admitted to inpatient rehabilitation post stroke.
INTERVENTIONS


Patient-Directed Activity Program (PDAP) or control (usual care only). Both groups underwent control (three hours of therapy/day), while PDAP participants were prescribed two additional 30-minute activity sessions/day.
MAIN MEASURES


Outcomes (Stroke Rehabilitation Assessment of Movement Measure, Functional Independence Measure, balance, physical activity, Stroke Impact Scale) were collected at admission and discharge from inpatient rehabilitation and three-month follow-up.
RESULTS


Seventy-three patients (PDAP ( n  = 37); control ( n  = 36)) were included in the primary analysis. Patients in PDAP completed a total of 23.1 ± 16.5 sessions (10.7 ± 8.5 upper extremity; 12.4 ± 8.6 lower extremity) during inpatient rehabilitation. No differences were observed between groups at discharge in functional measures. PDAP completed significantly more steps/day (PDAP = 657.70 ± 655.82, control = 396.17 ± 419.65;  P  = 0.022). The Stroke Impact Scale showed significantly better memory and thinking (PDAP = 86.2 ± 11.4, control = 80.8 ± 16.7;  P  = 0.049), communication (PDAP = 93.6 ± 8.3, control = 89.6 ± 12.4;  P  = 0.042), mobility (PDAP = 62.2 ± 22.5, control = 53.8 ± 21.8;  P  = 0.038), and overall recovery from stroke (PDAP = 62.1 ± 19.1, control = 52.2 ± 18.7;  P  = 0.038) for PDAP compared to control. At three months post discharge, PDAP ( n  = 11) completed significantly greater physical activity ( P  = 0.014; 3586.5 ± 3468.5 steps/day) compared to control ( n  = 10; 1760.9 ± 2346.3 steps/day).
CONCLUSION


Functional outcome improvement was comparable between groups; however, PDAP participants completed more steps and perceived greater recovery.",2020,"The Stroke Impact Scale showed significantly better memory and thinking (PDAP = 86.2 ± 11.4, control = 80.8 ± 16.7;  P  = 0.049), communication (PDAP = 93.6 ± 8.3, control = 89.6 ± 12.4;  P  = 0.042), mobility (PDAP = 62.2 ± 22.5, control = 53.8 ± 21.8;  P  = 0.038), and overall recovery from stroke (PDAP = 62.1 ± 19.1, control = 52.2 ± 18.7;  P  = 0.038) for PDAP compared to control.","['Patients admitted to inpatient rehabilitation post stroke', 'Seventy-three patients (PDAP ( n \u2009=\u200937); control ( n \u2009=\u200936)) were included in the primary analysis', 'people post stroke during inpatient rehabilitation and (2', 'Patients in PDAP completed a total of 23.1\u2009±\u200916.5 sessions (10.7\u2009±\u20098.5 upper extremity; 12.4\u2009±\u20098.6 lower extremity) during inpatient rehabilitation']","['patient-directed activity program', 'Patient-Directed Activity Program']","['physical activity', 'Outcomes (Stroke Rehabilitation Assessment of Movement Measure, Functional Independence Measure, balance, physical activity, Stroke Impact Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}]",73.0,0.0405,"The Stroke Impact Scale showed significantly better memory and thinking (PDAP = 86.2 ± 11.4, control = 80.8 ± 16.7;  P  = 0.049), communication (PDAP = 93.6 ± 8.3, control = 89.6 ± 12.4;  P  = 0.042), mobility (PDAP = 62.2 ± 22.5, control = 53.8 ± 21.8;  P  = 0.038), and overall recovery from stroke (PDAP = 62.1 ± 19.1, control = 52.2 ± 18.7;  P  = 0.038) for PDAP compared to control.","[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Swank', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Trammell', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Librada', 'Initials': 'L', 'LastName': 'Callender', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Baylor Scott & White Health, Dallas, TX, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Gillespie', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Driver', 'Affiliation': 'Baylor Scott & White Institute for Rehabilitation, Dallas, TX, USA.'}]",Clinical rehabilitation,['10.1177/0269215519901153']
399,32026701,Effects of an integrated transitional care program for stroke survivors living in a rural community: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of an integrated transitional care program on health outcomes in stroke survivors based on an original community for healthcare.
DESIGN


A pilot randomized controlled trial with blinded assessment. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes.
SETTING


A tertiary hospital and participants' home across Lishui, China.
SUBJECTS


A total of 98 people with acute cerebral hemorrhage or cerebral infarction, eight weeks following discharge from our hospital.
INTERVENTIONS


Each participant received stroke unit-based treatment including acute medical treatment, early rehabilitation and health education. Patients in the intervention group received ongoing rehabilitation at home through multidisciplinary team, while patients in the control group received secondary stroke prevention.
MAIN MEASURES


Short-Form Health Survey-36, Modified Barthel Index and Caregiver Strain Index at four and eight weeks, respectively, after discharged.
RESULTS


A total of 98 participants were recruited (intervention  n  = 49, control  n  = 49). Patients had an average age of 61.4 years (61.4 ± 18.3). Mean values of Physical Components Summary and Mental Components Summary, integral components of Short-Form Health Survey-36, were significantly better in the intervention group at four and eight weeks (40.2 ± 6.3 and 42.9 ± 3.7 for the former; 43.9 ± 2.6 and 46.1 ± 1.8 for the later). The same trend was observed in Modified Barthel Index (87.1 ± 9.2 and 92.5 ± 6.7 at four and eight weeks, respectively). But the significant improvement in Caregiver Strain Index was only observed at four weeks. There were significant differences between groups in these scores.
CONCLUSION


The transitional care program has been proven to be feasible and improve health-related outcomes.",2020,"There were significant differences between groups in these scores.
","['Patients had an average age of 61.4\u2009years (61.4\u2009±\u200918.3', '98 people with acute cerebral hemorrhage or cerebral infarction, eight weeks following discharge from our hospital', ""A tertiary hospital and participants' home across Lishui, China"", '98 participants were recruited (intervention  n  = 49, control  n  = 49', 'stroke survivors living in a rural community', 'stroke survivors based on an original community for healthcare']","['control group received secondary stroke prevention', 'stroke unit-based treatment including acute medical treatment, early rehabilitation and health education', 'ongoing rehabilitation at home through multidisciplinary team', 'integrated transitional care program']","['Short-Form Health Survey-36, Modified Barthel Index and Caregiver Strain Index', 'Caregiver Strain Index', 'Mean values of Physical Components Summary and Mental Components Summary, integral components of Short-Form Health Survey-36', 'Modified Barthel Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0018701'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}]",98.0,0.138624,"There were significant differences between groups in these scores.
","[{'ForeName': 'Aiwen', 'Initials': 'A', 'LastName': 'Deng', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Sidong', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Ribo', 'Initials': 'R', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation, Nanhai Hospital, Southern Medical University, Foshan, China.'}]",Clinical rehabilitation,['10.1177/0269215520905041']
400,32037862,Effects of pressure garment on spasticity and function of the arm in the early stages after stroke: a randomized controlled trial.,"OBJECTIVE


To investigate the effects of pressure (Lycra) garment on the spasticity and function of the arm in the early stages after stroke.
DESIGN


A randomized controlled trial.
SETTING


Occupational therapy unit of a public hospital.
SUBJECTS


A total of 46 adults with stroke.
INTERVENTION


After random assignment, for six weeks, both intervention group and control group received a 2 hour/week conventional occupational therapy program, with the intervention group receiving an extra 6 hour/day pressure garment application (long glove).
MAIN MEASURES


Modified Modified Ashworth Scale, Disabilities of Arm, Shoulder and Hand Outcome Measure, and Jebsen-Taylor Hand Function Test. Eligibility measures: Mini Mental State Examination and Modified Modified Ashworth Scale. Assessments were performed at baseline and six weeks postintervention.
RESULTS


There were 21 participants with the mean age of 51.19 (8.28) years in the intervention group and 22 participants with the mean (SD) age of 52.82 (8.71) years in the control group. The intervention group had median (interquartile range (IQR)) post-stroke duration of 1 (1) month, while for the control group, they were 2 (2) months. There was no difference in spasticity, and both perceived and actual arm functions between the groups at six weeks after baseline.
CONCLUSION


Wearing a pressure garment on the arm for 6 hours daily had no effect in controlling spasticity or on improving arm function in the early stages after stroke.",2020,"There was no difference in spasticity, and both perceived and actual arm functions between the groups at six weeks after baseline.
CONCLUSION


","['Occupational therapy unit of a public hospital', 'early stages after stroke', 'A total of 46 adults with stroke', '21 participants with the mean age of 51.19 (8.28)\u2009years in the intervention group and 22 participants with the mean (SD) age of 52.82 (8.71)\u2009years in the control group']","['pressure', 'control group received a 2\u2009hour/week conventional occupational therapy program, with the intervention group receiving an extra 6\u2009hour/day pressure garment application (long glove', 'pressure garment']","['Eligibility measures: Mini Mental State Examination and Modified Modified Ashworth Scale', 'spasticity, and both perceived and actual arm functions', 'Modified Modified Ashworth Scale, Disabilities of Arm, Shoulder and Hand Outcome Measure, and Jebsen-Taylor Hand Function Test', 'median (interquartile range (IQR)) post-stroke duration', 'spasticity and function']","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1283059', 'cui_str': 'Pressure garments'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",46.0,0.0826167,"There was no difference in spasticity, and both perceived and actual arm functions between the groups at six weeks after baseline.
CONCLUSION


","[{'ForeName': 'Hwa Kee', 'Initials': 'HK', 'LastName': 'Ooi', 'Affiliation': 'Occupational Therapy Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siaw Chui', 'Initials': 'SC', 'LastName': 'Chai', 'Affiliation': 'Occupational Therapy Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Masne', 'Initials': 'M', 'LastName': 'Kadar', 'Affiliation': 'Occupational Therapy Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}]",Clinical rehabilitation,['10.1177/0269215520905050']
401,32063035,Efficacy of continuous and pulsed therapeutic ultrasound combined with exercises for knee osteoarthritis: a randomized controlled trial.,"OBJECTIVES


To compare the effects of continuous and pulsed therapeutic ultrasound combined with strengthening exercises.
DESIGN


This is a double-blind randomized controlled trial.
SETTING


Pontifical Catholic University.
SUBJECTS


One hundred participants with Grade 2-4 knee osteoarthritis and both genders were involved.
INTERVENTION


Participants were randomized into five groups: Group I ( n  = 20; in the first month, continuous ultrasound was applied), Group II ( n  = 20; in the first month, pulsed ultrasound was applied), Group III ( n  = 20; in the first and second months, continuous ultrasound was applied), Group IV ( n  = 20; in the first and second months, pulsed ultrasound was applied) and Group V ( n  = 20; patients received only exercise sessions for eight weeks). All patients in the groups that received ultrasound application performed exercises in the second month of treatment. The sessions occurred three times a week.
MAIN MEASURES


Pain was assessed using the visual analogical scale, functionality was assessed using the Lequesne questionnaire, range of motion was assessed using a universal goniometer, muscular strength was assessed using a dynamometer, mobility was assessed using the Timed Up and Go test and 8-meter walk test and the activity level was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.
RESULTS


Statistically significant differences ( P  < 0.05) were presented by Group III in the variables pain during activities of daily living (ADLs) 5.89 (2.18), mobility assessed by 8-meter test 2.68 (2.56), in pain 10.65 (4.40), function 25.50 (10.87) and total 38.65 (15.29) of WOMAC and functionality 9.10 (5.15).
CONCLUSION


Prolonged applications of continuous ultrasound combined with exercises are effective in providing pain, mobility, functionality and activity in subjects with knee osteoarthritis.",2020,"Prolonged applications of continuous ultrasound combined with exercises are effective in providing pain, mobility, functionality and activity in subjects with knee osteoarthritis.","['knee osteoarthritis', 'One hundred participants with Grade 2-4 knee osteoarthritis and both genders were involved', 'subjects with knee osteoarthritis', 'Pontifical Catholic University']","['continuous ultrasound combined with exercises', 'continuous and pulsed therapeutic ultrasound combined with exercises', 'pulsed ultrasound was applied) and Group V ( n \u2009=\u200920; patients received only exercise sessions', 'continuous and pulsed therapeutic ultrasound combined with strengthening exercises', 'ultrasound application performed exercises']","['Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire', 'visual analogical scale, functionality was assessed using the Lequesne questionnaire, range of motion was assessed using a universal goniometer, muscular strength was assessed using a dynamometer, mobility was assessed using the Timed Up and Go test and 8-meter walk test and the activity level', 'pain, mobility, functionality and activity']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441855', 'cui_str': 'Group V (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",100.0,0.0224922,"Prolonged applications of continuous ultrasound combined with exercises are effective in providing pain, mobility, functionality and activity in subjects with knee osteoarthritis.","[{'ForeName': 'Patrícia Pereira', 'Initials': 'PP', 'LastName': 'Alfredo', 'Affiliation': 'Department of Speech Therapy, Physical Therapy and Occupational Therapy, School of Medicine, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Washington Steagall', 'Initials': 'WS', 'LastName': 'Junior', 'Affiliation': 'Department of Dentistry, School of Odontology, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Raquel Aparecida', 'Initials': 'RA', 'LastName': 'Casarotto', 'Affiliation': 'Department of Speech Therapy, Physical Therapy and Occupational Therapy, School of Medicine, São Paulo University, São Paulo, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520903786']
402,31964174,Effects of an individually targeted multicomponent counseling and home-based rehabilitation program on physical activity and mobility in community-dwelling older people after discharge from hospital: a randomized controlled trial.,"OBJECTIVES


The aim of this study is to evaluate the effects of multicomponent rehabilitation on physical activity, sedentary behavior, and mobility in older people recently discharged from hospital.
DESIGN


Randomized controlled trial.
SETTING


Home and community.
PARTICIPANTS


Community-dwelling people aged ⩾60 years recovering from a lower limb or back musculoskeletal injury, surgery, or disorder were recruited from local health center hospitals and randomly assigned into an intervention ( n  = 59) or a control (standard care,  n  = 58) group.
INTERVENTION


The six-month intervention consisted of a motivational interview, goal attainment process, guidance for safe walking, a progressive home exercise program, physical activity counseling, and standard care.
MEASUREMENTS


Physical activity and sedentary time were assessed using an accelerometer and a single question. Mobility was evaluated with the Short Physical Performance Battery, self-reported use of a walking aid, and ability to negotiate stairs and walk outdoors. Intervention effects were analyzed with generalized estimating equations.
RESULTS


Daily physical activity was 127 ± 78 minutes/day and 121 ± 70 at baseline and 167 ± 81 and 164 ± 72 at six months in the intervention and control group, respectively; mean difference of 3.4 minutes (95% confidence interval (CI) = -20.3 to 27.1). In addition, no significant between-group differences were shown in physical performance.
CONCLUSION


The rehabilitation program was not superior to standard care for increasing physical activity or improving physical performance. Mobility-limited older people who had recently returned home from hospital would have needed a longer and more frequently monitored comprehensive geriatric intervention.",2020,The rehabilitation program was not superior to standard care for increasing physical activity or improving physical performance.,"['Community-dwelling people aged ⩾60 years recovering from a lower limb or back musculoskeletal injury, surgery, or disorder were recruited from local health center hospitals and randomly assigned into an intervention ( n  = 59) or a', 'Home and community', 'community-dwelling older people after discharge from hospital', 'older people recently discharged from hospital', 'Mobility-limited older people who had recently returned home from hospital']","['multicomponent rehabilitation', 'motivational interview, goal attainment process, guidance for safe walking, a progressive home exercise program, physical activity counseling, and standard care', 'multicomponent counseling and home-based rehabilitation program', 'control (standard care,  n  = 58) group']","['Physical activity and sedentary time', 'physical activity, sedentary behavior, and mobility', 'physical activity and mobility', 'physical performance', 'Short Physical Performance Battery, self-reported use of a walking aid, and ability to negotiate stairs and walk outdoors', 'Mobility']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0579192', 'cui_str': 'Returned home, life event (finding)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557834', 'cui_str': 'Walking aid (physical object)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0695835,The rehabilitation program was not superior to standard care for increasing physical activity or improving physical performance.,"[{'ForeName': 'Katri M', 'Initials': 'KM', 'LastName': 'Turunen', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Aaltonen-Määttä', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Törmäkangas', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sirkka', 'Initials': 'S', 'LastName': 'Keikkala', 'Affiliation': 'Finland Health Centre Hospital, Health Centre of Jyväskylä Cooperation Area, City of Jyväskylä, Finland.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Kinnunen', 'Affiliation': 'Finland Health Centre Hospital, Health Centre of Jyväskylä Cooperation Area, City of Jyväskylä, Finland.'}, {'ForeName': 'Taija', 'Initials': 'T', 'LastName': 'Finni', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Nikander', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Clinical rehabilitation,['10.1177/0269215519901155']
403,32132009,"Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and Cost for Adults in South Bronx, New York.","OBJECTIVE


Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years.
RESEARCH DESIGN AND METHODS


We measured inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm.
RESULTS


During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97;  P  < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99;  P  = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98;  P  = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
CONCLUSIONS


These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs.",2020,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","['predominantly Latino and African American population in New York City', 'Adults in South Bronx, New York', 'inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014']","['Bronx A1C intervention', 'Telephonic Intervention', 'telephonic diabetes intervention (Tele/Pr) arm and print-only control (PrO) arm', 'telephonic diabetes self-management intervention (Bronx A1C']","['Health Care Utilization and Cost', 'hospital use and costs', 'number of hospital stays', 'blood glucose control', 'glycemic control', 'health care utilization and costs', 'hospital costs']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}]","[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0255034,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","[{'ForeName': 'Bahman P', 'Initials': 'BP', 'LastName': 'Tabaei', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY btabaei@health.nyc.gov.'}, {'ForeName': 'Renata E', 'Initials': 'RE', 'LastName': 'Howland', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Chamany', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}]",Diabetes care,['10.2337/dc19-0954']
404,32222326,Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling.,"BACKGROUND


Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources.
METHODS


This cluster randomized controlled trial will implement an evidence-based, multi-faceted physical activity intervention. All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics will be approached, with randomization to intervention/control by clinic and week. Intervention patients will be counselled with 5 key physical activity messages, have questions about physical activity answered, and have access to a custom web site with personalized activity suggestions and support from a Registered Kinesiologist. The primary outcome is daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months. Standardized questionnaires assess activity motivation and quality of life at baseline and end of study. Healthcare outcomes will be clinic visit time and contacts for physical activity concerns. Repeated measures ANCOVA will compare control/intervention pedometer outcomes, adjusting for covariates (alpha=0.05).
CONCLUSIONS


This trial aims to determine whether providing resources and protocols enables clinicians to counsel about physical activity as part of every pediatric cardiology appointment. Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics. The impact on physical activity motivation and participation will evaluate the effectiveness of this standardized approach for increasing physical activity in children with congenital heart defects.",2020,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","['children with congenital health defects', 'Most (>90%) children with congenital health defects', 'all pediatric cardiac clinics', 'All eligible patients at small (London, ON), medium (Ottawa, ON) and large (Edmonton, AB) pediatric cardiac clinics', 'congenital heart disease']",['clinic physical activity counselling'],"['daily physical activity (number of steps, minutes of moderate-to-vigorous activity) assessed via pedometer one week per month for 6-months', 'Standardized questionnaires assess activity motivation and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034380'}]",,0.168498,"Evaluations of healthcare system impact and intervention delivery in small, medium and large clinics will assess applicability for implementation in all pediatric cardiac clinics.","[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lemire', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Yaraskavitch', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lougheed', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Department of Pediatrics, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': ""Department of Pediatrics, Pediatric Cardiology, Schulich School of Medicine and Dentistry, Western University & Children's Health Research Institute, London, Ontario, Canada; Paediatric Cardiology and Intensive Care Medicine, Medical School Hannover, Germany.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Canadian Congenital Heart Alliance, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Longmuir', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada; University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada. Electronic address: plongmuir@cheo.on.ca.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.105994']
405,32220091,Improved quality of care by using the PRISMS form to support self-management in patients with COPD: A Randomised Controlled Trial.,"AIMS AND OBJECTIVE


To investigate the effects on the quality of care of the Patient Report Informing Self-Management Support (PRISMS) form compared with usual care among patients with chronic obstructive pulmonary disease (COPD) consulting a COPD nurse in primary health care.
BACKGROUND


Patients with COPD experience symptoms affecting their everyday lives, and there is a need for interventions in self-management support. The delivery of chronic care in an organised, structured and planned manner can lead to more productive relationships between professionals and patients.
DESIGN


A multicentre randomised controlled trial with a post-test design, according to the CONSORT checklist, in one intervention group (n = 94) and one control group (n = 108).
METHODS


In addition to usual care, the intervention group (n = 94) completed the PRISMS form to indicate areas where they wanted self-management support before the consultation with the COPD nurse. This form comprises 17 items that patients with COPD commonly experience as problems. The control group received usual care (n = 108). The primary outcome was patients' satisfaction with quality of care, assessed using the Quality from the Patient's Perspective (QPP) questionnaire. Means and (SD) are presented where applicable. Differences between the intervention and control group were analysed with Student's t test for independent groups for interval data, and the Mann-Whitney U test for ordinal data.
RESULTS


Participants in the intervention group were more satisfied with the QPP domains ""personal attention,"" regarding both ""perceived reality"" (p = .021) and ""subjective importance"" (p = .012). The PRISMS form revealed ""shortness of breath"" as the most commonly experienced problem and the issue most desired to discuss.
CONCLUSION


The PRISMS form improved patient satisfaction with quality of care regarding personal attention, which is an important factor in patient participation and improving relationships and communication.
RELEVANCE TO CLINICAL PRACTICE


The PRISMS form can be a useful tool in improving person-centred care when delivering self-management support.
REGISTER ID


192691 at http://www.researchweb.org/is/en/sverige/project/192691.",2020,"RESULTS


Participants in the intervention group were more satisfied with the QPP domains ""personal attention"", regarding both ""Perceived reality"" (p=0.021) and ""Subjective Importance"" (p=0.012).","['patients with Chronic Obstructive Pulmonary Disease (COPD) consulting a COPD nurse in primary health care', 'Patients with COPD experience symptoms affecting their everyday lives', 'patients with COPD', 'patients with COPD commonly experience as problems']","['usual care', 'Self-Management Support (PRISMS']","['Improved quality of care', 'Subjective Importance', 'QPP domains ""personal attention"", regarding both ""Perceived reality', ""patients' satisfaction with quality of care, assessed using the Quality from the Patient's Perspective (QPP) questionnaire""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0766278,"RESULTS


Participants in the intervention group were more satisfied with the QPP domains ""personal attention"", regarding both ""Perceived reality"" (p=0.021) and ""Subjective Importance"" (p=0.012).","[{'ForeName': 'Ann-Britt', 'Initials': 'AB', 'LastName': 'Zakrisson', 'Affiliation': 'Department of University Healthcare Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Arne', 'Affiliation': 'Centre for Clinical Research, RegionVärmland, Karlstad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lisspers', 'Affiliation': 'Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Lundh', 'Affiliation': 'NVS, Division of Family Medicine and Primary Care, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sandelowsky', 'Affiliation': 'NVS, Division of Family Medicine and Primary Care, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ställberg', 'Affiliation': 'Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Thors Adolfsson', 'Affiliation': 'Primary Health Care, Region Västmanland, Västerås, Sweden.'}, {'ForeName': 'Kersti', 'Initials': 'K', 'LastName': 'Theander', 'Affiliation': 'Centre for Clinical Research, RegionVärmland, Karlstad, Sweden.'}]",Journal of clinical nursing,['10.1111/jocn.15253']
406,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
407,32221020,Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation): a novel surgical technique for advanced ovarian cancer.,"BACKGROUND


A Total Retroperitoneal en bloc resection Of Multivisceral-Peritoneal packet (TROMP operation) is a no-touch isolation technique in a retroperitoneal space to resect the parietal peritoneum and the affected organs in advanced ovarian cancer. The study prescribed and analysed the results of this novel technique for primary cytoreductive surgery.
METHODS


The study included 208 patients operated between January 2015 and December 2017 in Charité, Berlin. The TROMP operation was performed in 58 patients, whereas the other 150 patients were operated with the conventional cytoreductive method.
RESULTS


The complete tumor resection rate accounts for 87.9% in TROMP group and 61.3% in the conventional surgery group. (p=0.001). This difference was even stronger in the sub-group of very advanced stages (T3c+T4) (85.1% of TROMP group and in only 53.1% in the conventional surgery group, p=0.001). The duration of the primary cytoreductive surgery was about 33 minutes shorter in TROMP group (median: 335 minutes vs 368 minutes; TROMP vs conventional, respectively) in spite of the fact that the most advanced cytoreductive procedures were performed statically significant more in TROMP operation arm in comparison with the conventional surgery arm. There was no statistically significant difference between the groups regarding the postoperative complication, blood loss or the length of stay in intensive care unit.
CONCLUSION


Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation) is a feasible and very effective technique of surgical therapy in advanced ovarian cancer. This technique increased the complete tumor resection rate to 87.9% without increasing the blood loss, postoperative complications or the duration of surgery. A prospective randomized study is advised to validate these results.",2020,"There was no statistically significant difference between the groups regarding the postoperative complication, blood loss or the length of stay in intensive care unit.
","['58 patients, whereas the other 150 patients were operated with the conventional cytoreductive method', '208 patients operated between January 2015 and December 2017 in Charité, Berlin', 'advanced ovarian cancer']","['Total Retroperitoneal en bloc resection Of Multivisceral-Peritoneal packet (TROMP operation', 'TROMP', 'Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation']","['postoperative complication, blood loss or the length of stay in intensive care unit', 'complete tumor resection rate', 'blood loss, postoperative complications', 'duration of the primary cytoreductive surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal Space'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]",208.0,0.0220311,"There was no statistically significant difference between the groups regarding the postoperative complication, blood loss or the length of stay in intensive care unit.
","[{'ForeName': 'Mustafa Zelal', 'Initials': 'MZ', 'LastName': 'Muallem', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Virchow Campus Clinic, Charité Medical University, Berlin, Germany Mustafa-Zelal.Muallem@charite.de drzelal77@outlook.de.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Virchow Campus Clinic, Charité Medical University, Berlin, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Miranda', 'Affiliation': 'Ovarian Cancer Tumor Bank, Virchow Campus Clinic, Charité Medical University, Berlin, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Richter', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Virchow Campus Clinic, Charité Medical University, Berlin, Germany.'}, {'ForeName': 'Jumana', 'Initials': 'J', 'LastName': 'Muallem', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Virchow Campus Clinic, Charité Medical University, Berlin, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001161']
408,32222134,Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
METHODS


In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
RESULTS


Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
CONCLUSIONS


Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).",2020,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","['patients with high-risk heart failure', 'patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received', 'Patients with Heart Failure and Reduced Ejection Fraction', '5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive']","['vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy', 'placebo', 'intravenous diuretic therapy']","['syncope', 'Death from cardiovascular causes', 'Symptomatic hypotension', 'composite of death from cardiovascular causes or first hospitalization for heart failure', 'death from cardiovascular causes or hospitalization for heart failure', 'hospitalized for heart failure', 'composite of death from any cause or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",5050.0,0.580875,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915928']
409,32203968,"Vitamin D3 Supplementation in Diarrhea-Predominant Irritable Bowel Syndrome Patients: The Effects on Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6 - A Randomized Clinical Trial.","OBJECTIVES


This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D).
METHODS


Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions.
RESULTS


Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively).
CONCLUSION


Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.",2020,"The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH.","['patients with a diarrhea-predominant form of IBS (IBS-D', 'Seventy-four patients completed the study', 'Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency', 'IBS-D patients who suffer from vitamin D deficiency and/or insufficiency', 'Diarrhea-Predominant Irritable Bowel Syndrome Patients', 'irritable bowel syndrome (IBS) patients', 'controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran']","['vitamin D3 supplementation', 'Vitamin D3 supplementation', 'placebo', 'Mebeverine 135 mg twice a day besides supplementation', '50,000 IU vitamin D3', 'Vitamin D3 Supplementation', 'vitamin D deficiency']","['serum level of CRH', 'serum level of CRH and IL-6', 'IL-6', 'IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6', 'IBS-SSS and IL-6', 'serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6', 'Symptoms Improvement, Serum Corticotropin-Releasing Hormone, and Interleukin-6', 'severity of IBS symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1128349', 'cui_str': 'mebeverine 135 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",88.0,0.102162,"The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Khalighi Sikaroudi', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Faghihi Kashani', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Masoodi', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Nutrition, Islamic Azad University, Science and Research Branch, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dehnad', 'Affiliation': 'Department of English Language, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran, shidfar.f@iums.ac.ir.'}]",Complementary medicine research,['10.1159/000506149']
410,32134394,A Values-Tailored Web-Based Intervention for New Mothers to Increase Infant Vaccine Uptake: Development and Qualitative Study.,"BACKGROUND


Vaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation.
OBJECTIVE


This study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy.
METHODS


Development of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users.
RESULTS


In all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed.
CONCLUSIONS


Using health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual's values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial.",2020,Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient.,[],[],[],[],[],[],41.0,0.0498151,Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': 'University of Colorado, Denver, Aurora, CO, United States.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'University of Colorado, Denver, Aurora, CO, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'University of Colorado, Denver, Aurora, CO, United States.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': 'University of Colorado, Denver, Aurora, CO, United States.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'University of Colorado, Denver, Aurora, CO, United States.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Narwaney', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO, United States.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'University of Michigan, Department of Health Behavior & Health Education, School of Public Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Glanz', 'Affiliation': 'Kaiser Permanente Colorado Institute for Health Research, Denver, CO, United States.'}]",Journal of medical Internet research,['10.2196/15800']
411,32213209,Comparison of pain levels in fusion prostate biopsy and standard TRUS-Guided biopsy.,"OBJECTIVES


Fusion prostate biopsy (FPB) has recently emerged as a popular and successful biopsy technique on diagnosis of prostate cancer. The aim of this study was to compare the pain levels in TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB.
MATERIALS AND METHODS


Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS<3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) five minutes after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps.
RESULTS


252 patients were included in this study (Group I=159, Group II=93). The mean number of cores and the malignancy detection rate were significantly higher in Group I compared to Group II (p<0.001, p=0.043, respectively). No significant difference was found between the two groups with regard to VAS scores (p=0.070). The most painful part of the whole procedure was revealed to be the insertion of the probe into the rectum. However, no significant difference was found between the two groups with regard to the most painful biopsy step (p=0.140).
CONCLUSION


FPB, with a relatively higher cancer detection rate, leads to the same pain level as SPB although it increases the number of biopsy cores and involves a more complex procedure compared to SPB. Further prospective studies with larger patient series are needed to substantiate our findings.",2020,The mean number of cores and the malignancy detection rate were significantly higher in Group,"['Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS<3 lesion on MpMRI underwent TRUS-guided SPB (Group II', '252 patients were included in this study (Group I=159, Group II=93']","['fusion prostate biopsy and standard TRUS-Guided biopsy', 'TRUS-guided standard 12-core prostate biopsy (SPB) and MpMRI-guided FPB', 'https://www.intbrazjurol.com.br/pdf/aop/2019-0154OA.pdf', 'Fusion prostate biopsy (FPB']","['pain levels', 'VAS scores', 'Pain assessment', 'Visual Analog Scale (VAS', 'mean number of cores and the malignancy detection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",252.0,0.0177572,The mean number of cores and the malignancy detection rate were significantly higher in Group,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirtaş', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Sönmez', 'Affiliation': 'Department of Urology, Kayseri City Hospital, Kayseri, Turkey.'}, {'ForeName': 'Şevket Tolga', 'Initials': 'ŞT', 'LastName': 'Tombul', 'Affiliation': 'Department of Urology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Türev', 'Initials': 'T', 'LastName': 'Demirtaş', 'Affiliation': 'Department of Medical History and Ethics, Erciyes University, Kayseri, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0154']
412,31714506,Effects of Expressing Writing on organizational variables in Palliative Care health Professionals: an explorative study.,"BACKGROUND AND AIM


Healthcare professionals working in palliative care are exposed to emotionally intense conditions. Scientific literature suggests Expressive Writing as a valid tool for the adjustment to traumatic events. For health workers, EW represents an important support to prevent Compassion Fatigue and Burnout. As literature showed that Compassion Satisfaction, Group Cohesion and the Organizational Commitment are protective factors able to counter the onset of Compassion Fatigue and Burnout, the aim of this study is evaluating the effect of Expressive Writing protocol in Palliative Care workers on Compassion Satisfaction, Group Cohesion and Organizational Commitment.
METHODS


A quasi-experimental quantitative 2x2 prospective study was conducted with two groups and two measurements. 66 professionals were included. Outcome variables were measured using: Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions.
RESULTS


The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups. One significant difference in the pre-intervention assessment of Normative Commitment t (gl 64) = -2.008 for p< 0.05, higher in the control group, disappeared in the post intervention evaluation. An improvement trend in all variables within and between groups was present, with a positive assessment of utility from the participants.
CONCLUSIONS


This intervention did not significantly impact outcome variables. It is however conceivable that by modifying the intervention methodology, it could prove effective. The positive evaluation by the operators, suggests to keep trying modelling a protocol tailored on Palliative Care professionals.",2019,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"['66 professionals were included', 'Palliative Care health Professionals']","['Expressive Writing protocol', 'Expressing Writing']","['Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",66.0,0.0595422,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cosentino', 'Affiliation': 'University of Parma. chiara.cosentino1@unipr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Corte', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fioresi', 'Affiliation': ''}, {'ForeName': 'Fiorella', 'Initials': 'F', 'LastName': 'Molina Ojeda', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pastore', 'Affiliation': ''}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Severgnini', 'Affiliation': ''}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Spacci', 'Affiliation': ''}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Artioli', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i11-S.8946']
413,32086791,Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients ≥ 65 Years of Age.,"BACKGROUND


Opioid-induced constipation (OIC), the most common side effect of opioid treatment, is under-recognized and undertreated in older patients. Naldemedine, an oral, peripherally acting μ-opioid receptor antagonist (PAMORA), is approved in Japan, the United States, and the European Union for treatment of OIC in adult patients.
OBJECTIVE


This integrated analysis of three phase 3 trials (COMPOSE-1, COMPOSE-2, and COMPOSE-3) evaluated the safety and efficacy of naldemedine for up to 12 weeks in a subgroup of patients aged ≥ 65 years.
METHODS


Patients aged 18-80 years with chronic non-cancer pain for ≥ 3 months (treated with opioids for ≥ 3 months in COMPOSE-1 and COMPOSE-2) and OIC received oral naldemedine 0.2 mg or placebo once daily. Safety assessments included overall incidence of treatment-emergent adverse events (TEAEs), TEAEs in the gastrointestinal disorders System Organ Class, and TEAEs of opioid withdrawal or possible opioid withdrawal. Efficacy was based on the proportion of responders in COMPOSE-1 and COMPOSE-2, defined as having ≥ 3 spontaneous bowel movements/week and a ≥ 1-spontaneous bowel movement/week increase from baseline for ≥ 9 of 12 weeks and ≥ 3 of the last 4 weeks.
RESULTS


A total of 14.8% (344/2328) of patients were aged ≥ 65 years in all studies. The incidence of TEAEs in naldemedine-treated patients aged ≥ 65 years (45.9%) was comparable to that in patients aged ≥ 65 years receiving placebo (51.6%) and in the overall naldemedine group (47.1%). The incidence of gastrointestinal disorders System Organ Class TEAEs in naldemedine-treated patients aged ≥ 65 years (20.2%) was also comparable to that in patients aged ≥ 65 years receiving placebo (16.1%) and in the overall naldemedine group (21.8%). The incidence of TEAEs of opioid withdrawal with naldemedine was 1.1% in patients aged ≥ 65 years and 1.0% overall, and the incidence of TEAEs of possible opioid withdrawal was 1.1% in patients aged ≥ 65 years and 1.7% overall. The proportion of responders was higher in naldemedine-treated patients versus placebo, both overall (50.1% vs 34.1%; p < 0.0001) and in those aged ≥ 65 years (51.8% vs 37.6%).
CONCLUSIONS


This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ 65 years with chronic non-cancer pain. Safety and efficacy results were consistent with the overall patient population. CLINICALTRIALS.
GOV REGISTRATION


NCT01965158, NCT01993940, NCT01965652.",2020,This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ ,"['older patients', 'A total of 14.8% (344/2328) of patients were aged\u2009≥', 'adult patients', 'Patients aged 18-80\xa0years with chronic non-cancer pain for\u2009≥', 'patients aged\u2009≥', '65\xa0years with chronic non-cancer pain', 'Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy', 'naldemedine-treated patients aged\u2009≥']","['placebo', 'naldemedine', 'oral naldemedine 0.2\xa0mg or placebo', 'Naldemedine']","['Safety and Efficacy', 'Efficacy', 'incidence of TEAEs of opioid withdrawal with naldemedine', 'proportion of responders', 'overall incidence of treatment-emergent adverse events (TEAEs), TEAEs in the gastrointestinal disorders System Organ Class, and TEAEs of opioid withdrawal or possible opioid withdrawal', 'tolerated and effective', 'safety and efficacy', 'Safety and efficacy', 'incidence of TEAEs of possible opioid withdrawal']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4325237', 'cui_str': 'naldemedine 0.2 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.205418,This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ ,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Upstate Clinical Research Associates, 8201 Main Street, Suite 1, Williamsville, NY, 14221, USA. jwild@roadrunner.com.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Tadaaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Shionogi Inc., Florham Park, NJ, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Gold Coast Research LLC, Plantation, FL, USA.'}]",Drugs & aging,['10.1007/s40266-020-00753-2']
414,32157678,Opioid tapering after spine surgery: Protocol for a randomized controlled trial.,"BACKGROUND


Patients are often prescribed opioids at discharge from hospital following surgery. Several studies have shown that a large number of patients do not taper off but continue to use opioids after surgery. Tapering plans and follow-up after discharge may reduce opioid consumption.
METHODS


This is a single-centre, investigator-initiated, randomized, controlled trial. One hundred and ten preoperative opioid users, scheduled to undergo spine surgery at Aarhus University Hospital, Denmark, are randomized into two groups: 1) an intervention group receiving an individually customized tapering plan at discharge combined with telephone counselling one week after discharge; 2) a control group receiving no tapering plan or telephone counselling. The primary outcome is number of patients exceeding their preoperative intake one month after discharge. Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.
CONCLUSION


Our study is expected to provide valuable information on opioid tapering after surgery in patients with preoperative opioid use.",2020,"Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.","['One hundred and ten preoperative opioid users, scheduled to undergo spine surgery at Aarhus University Hospital, Denmark', 'patients with preoperative opioid use', 'Opioid tapering after spine surgery']",['intervention group receiving an individually customized tapering plan at discharge combined with telephone counselling one week after discharge 2) a control group receiving no tapering plan or telephone counselling'],"['number of patients exceeding their preoperative intake one month after discharge', 'withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]",110.0,0.20544,"Secondary outcomes are withdrawal symptoms during the first month after discharge, number of patients tapering off to zero three months after discharge, patient satisfaction and contacts with the health care system within the first two weeks after discharge.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Uhrbrand', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Phillipsen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mikkel M', 'Initials': 'MM', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13576']
415,31320010,Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method.,"OBJECTIVES


The aim of this study was to demonstrate that a stochastic vector-based mapping approach could guide ablation of atrial fibrillation (AF) drivers as evidenced by ablation response and long-term follow-up outcomes.
BACKGROUND


The optimal method for mapping and ablation of AF drivers is yet to be defined.
METHODS


Patients undergoing persistent AF ablation were recruited. Patients underwent pulmonary vein isolation (PVI) with further ablation guided by the stochastic trajectory analysis of ranked signals (STAR) mapping method. The proportion of the time an electrode's activation was seen to precede its neighboring electrodes activation was used to determine early sites of activation (ESA). A positive ablation response at ESA was defined as AF termination or cycle length slowing of ≥30 ms. Clinical outcome was defined as recurrence of AF/atrial tachycardia (AT) during a follow-up of 12 months.
RESULTS


Thirty-five patients were included (AF duration of 14.4 ± 5.3 months). After PVI, an average of 2.6 ± 0.8 ESA were ablated per patient with study-defined ablation response achieved in all patients. Of the 86 STAR maps created post-PVI, the same ESA was identified on 73.8 ± 26.1% of maps. ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001). During a follow-up of 18.5 ± 3.7 months, 28 (80%) patients were free from AF/AT.
CONCLUSIONS


The ablation response at ESA suggests they may be drivers of AF. Ablation guided by STAR mapping produced a favorable clinical outcome and warrants testing through a randomized controlled trial. (Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation [STAR MAPPING]; NCT02950844).",2019,ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001).,"['Thirty-five patients were included (AF duration of 14.4 ± 5.3\xa0months', 'Patients undergoing persistent AF ablation were recruited']","['Ablation guided by STAR mapping', 'ESA', 'stochastic vector-based mapping approach', 'pulmonary vein isolation (PVI) with further ablation guided by the stochastic trajectory analysis of ranked signals (STAR) mapping method']","['AF termination', 'recurrence of AF/atrial tachycardia (AT', 'ablation response']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",35.0,0.0341331,ESA that resulted in AF termination were more likely to be identified on both pre- and post-PVI maps than those associated with cycle length slowing (23 of 24 vs. 16 of 49; p < 0.001).,"[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Honarbakhsh', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Ross J', 'Initials': 'RJ', 'LastName': 'Hunter', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Ullah', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Keating', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Finlay', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schilling', 'Affiliation': 'Barts Heart Centre, Barts Health National Health Service Trust, London, United Kingdom. Electronic address: richard.schilling@bartshealth.nhs.uk.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.04.007']
416,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND


We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS


We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend  = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend  = 0.03); the association was primarily present for distal CRC (P- trend  = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction  < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend  = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION


Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
417,31414865,Cognitive-behavior therapy with and without parental involvement for anxious Chinese adolescents: A randomized controlled trial.,"This study evaluated the effectiveness of a culturally attuned group cognitive-behavior therapy (CBT) intervention for Chinese adolescents at risk for anxiety disorders in Hong Kong and the additive effects of parental involvement. A randomized controlled design was adopted. Assessments were gathered at pre- and posttreatment, and 6-month follow-up. Participants ( N  = 136) were randomly assigned to (a) CBT plus parental involvement (CBT-PI) ( n  = 46), (b) CBT ( n  = 45), and (c) social activity ( n  = 45) conditions. Data were analyzed according to the intention-to-treat principle using multilevel modeling. The CBT-PI condition showed a greater reduction in physical injury fears compared with the CBT condition. The current findings suggest that involving parents in CBT for Chinese adolescents with anxiety problems may provide a small improvement in treatment efficacy. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The CBT-PI condition showed a greater reduction in physical injury fears compared with the CBT condition.,"['Participants ( N  = 136', 'Chinese adolescents at risk for anxiety disorders in Hong Kong', 'anxious Chinese adolescents', 'Chinese adolescents with anxiety problems']","['culturally attuned group cognitive-behavior therapy (CBT) intervention', 'CBT plus parental involvement (CBT-PI', 'Cognitive-behavior therapy with and without parental involvement']",['physical injury fears'],"[{'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",2019.0,0.0693672,The CBT-PI condition showed a greater reduction in physical injury fears compared with the CBT condition.,"[{'ForeName': 'Daniel Fu Keung', 'Initials': 'DFK', 'LastName': 'Wong', 'Affiliation': 'Department of Social Work and Social Administration.'}, {'ForeName': 'Ting Kin', 'Initials': 'TK', 'LastName': 'Ng', 'Affiliation': 'Wofoo Joseph Lee Consulting and Counselling Psychology Research Centre.'}, {'ForeName': 'Xiao Yu', 'Initials': 'XY', 'LastName': 'Zhuang', 'Affiliation': 'Department of Social Work and Social Administration.'}, {'ForeName': 'Paul W C', 'Initials': 'PWC', 'LastName': 'Wong', 'Affiliation': 'Department of Social Work and Social Administration.'}, {'ForeName': 'Janet T Y', 'Initials': 'JTY', 'LastName': 'Leung', 'Affiliation': 'Department of Applied Social Sciences.'}, {'ForeName': 'Irene Kit Man', 'Initials': 'IKM', 'LastName': 'Cheung', 'Affiliation': 'Department of Social Work and Social Administration.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000585']
418,31053215,Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans.,"STUDY OBJECTIVES


To examine the efficacy of imagery rehearsal (IR) combined with cognitive behavioral therapy for insomnia (CBT-I) compared to CBT-I alone for treating recurrent nightmares in military veterans with posttraumatic stress disorder (PTSD).
METHODS


In this randomized controlled study, 108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares were randomized to six sessions of IR + CBT-I (n = 55) or CBT-I (n = 53). Primary outcomes were measured with the Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ).
RESULTS


Improvement with treatment was significant (29% with reduction in nightmare frequency and 22% with remission). Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval = -0.87 to 0.63; likelihood ratio chi square = 4.7(3),  P  = .2); NDQ: 1.5, 95% confidence interval = -1.4 to 4.4; likelihood ratio chi square = 7.3,  P  = .06).
CONCLUSIONS


Combining IR with CBT-I conferred no advantage overall. Further research is essential to examine the possibly greater benefit of adding IR to CBT-I for some subgroups of veterans with PTSD.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans; Identifier: NCT00691626; URL: https://clinicaltrials.gov/ct2/show/NCT00691626.",2019,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","['108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares', 'Posttraumatic Nightmares in Combat Veterans', 'military veterans with posttraumatic stress disorder (PTSD']","['IR + CBT-I (n = 55) or CBT', 'imagery rehearsal (IR) combined with cognitive behavioral therapy', 'CBT-I alone', 'Imagery Rehearsal', 'Cognitive Behavioral Therapy (CBT']",['Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ'],"[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",108.0,0.0549086,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","[{'ForeName': 'Gerlinde C', 'Initials': 'GC', 'LastName': 'Harb', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Cook', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Phelps', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Gehrman', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Forbes', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Harpaz-Rotem', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7770']
419,31178001,Influence of Methylphenidate on Long-Term Neuropsychological and Everyday Executive Functioning After Traumatic Brain Injury in Children with Secondary Attention Problems.,"OBJECTIVE


To investigate the effects of methylphenidate on long-term executive and neuropsychological functioning in children with attention problems following TBI, as well as the relationship between methylphenidate associated changes in lab-based neuropsychological measures of attentional control, processing speed, and executive functioning and parent- or self-report measures of everyday executive functioning.
METHOD


26 children aged 6-17 years, who were hospitalized for moderate-to-severe blunt head trauma 6 or more months previously, were recruited from a large children's hospital medical center. Participants were randomized into a double-masked, placebo-controlled cross-over clinical trial. Participants completed a comprehensive neuropsychological battery and parent- and self-report ratings of everyday executive functioning at baseline, and at 4 weeks and 8 weeks following upward titration of medication to an optimal dose or while administered a placebo.
RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning. Significant treatment-by-period interactions were found on a task of sustained attention. Participants who were randomized to the methylphenidate condition for the first treatment period demonstrated random or erratic responding, with slower and more variable response times when given placebo during the second period.
CONCLUSION


Results indicate that methylphenidate treatment is associated with positive outcomes in processing speed, sustained attention, and both lab-based and everyday measures of executive functioning compared to placebo group. Additionally, results suggest sustained attention worsens when discontinuing medication. (JINS, 2019, 25, 740-749).",2019,"RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning.","['Children with Secondary Attention Problems', 'children with attention problems following TBI', ""26 children aged 6-17 years, who were hospitalized for moderate-to-severe blunt head trauma 6 or more months previously, were recruited from a large children's hospital medical center""]","['methylphenidate', 'Methylphenidate', 'placebo']","['Long-Term Neuropsychological and Everyday Executive Functioning', 'processing speed, sustained attention, and both lab-based and everyday measures of executive functioning', 'processing speed, sustained attention, and both lab-based and everyday executive functioning', 'comprehensive neuropsychological battery and parent- and self-report ratings of everyday executive functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery (assessment scale)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",26.0,0.259791,"RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LeBlond', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smith-Paine', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jacqlyn J', 'Initials': 'JJ', 'LastName': 'Riemersma', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, Ohio, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, Ohio, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Physical Medicine and Rehabilitation, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 4009, Cincinnati, Ohio, USA.""}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000444']
420,31747012,Oxidized regenerated cellulose for a clear thoracoscopic view: a single-centre randomized trial.,"OBJECTIVES


During video-assisted thoracoscopic surgery (VATS), blood oozing from the surface of the access port wound can hamper the surgical view. Although this oozing is difficult to prevent, it can be decreased by placing a wound edge protector with oxidized regenerated cellulose (ORC) on the surface of the access port wound, thereby improving the surgical outcomes and safety of VATS.
METHODS


We conducted a prospective, single-centre, open-label, randomized clinical trial to evaluate the operative outcomes of VATS when using the ORC (ORC group) compared with operative outcomes without using the ORC (non-ORC group). The primary end point was interruption of the operation as a result of blood oozing from the surface of the access port wound. The secondary end points were the other intraoperative and postoperative outcomes.
RESULTS


A total of 108 patients were divided into the ORC group (n = 54) and the non-ORC group (n = 54). Compared with the non-ORC group, the ORC group had fewer patients with an interruption in the operation (11.1% vs 51.8%; P < 0.001), less need for wound haemostasis of the access ports during wound closure (44.4% vs 72.2%; P = 0.003), similar rates of postoperative deaths and complications and a tendency for shorter operation times (149.3 vs 168.8 min, respectively; P = 0.083).
CONCLUSION


The use of an ORC sheet around a wound edge protector for haemostasis can ensure a clear view during VATS.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000031112.",2020,The primary end point was interruption of the operation as a result of blood oozing from the surface of the access port wound.,['108 patients'],"['Oxidized regenerated cellulose', 'ORC', 'video-assisted thoracoscopic surgery (VATS']","['wound haemostasis of the access ports during wound closure', 'interruption of the operation as a result of blood oozing from the surface of the access port wound', 'postoperative deaths and complications', 'intraoperative and postoperative outcomes', 'shorter operation times']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005768'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0277599', 'cui_str': 'Postoperative death (event)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",108.0,0.0814653,The primary end point was interruption of the operation as a result of blood oozing from the surface of the access port wound.,"[{'ForeName': 'Nahoko', 'Initials': 'N', 'LastName': 'Shimizu', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hayate', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Mitsui', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shuto', 'Initials': 'S', 'LastName': 'Sakai', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hokka', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Maniwa', 'Affiliation': 'Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz271']
421,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
422,31529194,Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial.,"BACKGROUND


Superficial surgical site infections are a common post-operative complication. They also place a considerable financial burden on healthcare. The use of prophylactic negative pressure wound therapy has been advocated to reduce wound infection rates. However, there is debate around its routine use. The purpose of this trial is to determine if prophylactic negative pressure wound therapy reduces post-operative wound complications in patients undergoing laparotomy.
METHODS/DESIGN


This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™). All patients will be over 18 years, who are undergoing an emergency or elective laparotomy. It is intended to enrol a total of 271 patients for the trial.
DISCUSSION


The PROPEL trial is a multi-centre randomised controlled trial of patients undergoing laparotomy. The comparison of standard treatment to two commercially available NPWT will help provide consensus on the routine management of laparotomy wounds.
TRIAL REGISTRATION


This study is registered with ClinicalTrials.gov (NCT number NCT03871023).",2019,This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™).,"['271 patients for the trial', 'patients undergoing laparotomy', 'All patients will be over 18\xa0years, who are undergoing an emergency or elective laparotomy']","['prophylactic negative pressure wound therapy', 'Prophylactic negative wound therapy', 'standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™']",['wound infection rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3653515', 'cui_str': 'SURGICAL DRESSINGS'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",271.0,0.265031,This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™).,"[{'ForeName': 'Noel Edward', 'Initials': 'NE', 'LastName': 'Donlon', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland. donlonn@tcd.ie.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Boland', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Kelly', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Department of Surgery, Wexford General Hospital, Wexford, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cooke', 'Affiliation': 'Department of Surgery, University Hospital Waterford, Waterford, Ireland.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Neary', 'Affiliation': 'Department of Surgery, University Hospital Waterford, Waterford, Ireland.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Barry', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Mayo, Ireland.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Reynolds', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}]",International journal of colorectal disease,['10.1007/s00384-019-03398-9']
423,30958012,Mechanisms of behavior change in a brief dual-target motivational intervention: Reduction in alcohol use mediates intervention effects on risky sex.,"To examine the mechanisms underlying the efficacy of a dual-target motivational intervention (MI) to reduce heavy drinking and risky sex. A priori hypotheses were that: increases in alcohol-related readiness to change (RTC) and self-efficacy would mediate the effect of MI on alcohol use; increases in sex-related RTC and self-efficacy would mediate the effect of MI on risky sex; and reductions in alcohol use would mediate reductions in risky sex. Patients in Emergency Departments who screened positive for heavy drinking and risky sex were randomly assigned to receive MI or brief advice. RTC and self-efficacy were assessed at baseline and immediately postintervention. Alcohol use and sexual behavior was assessed at baseline, 3-, 6-, and 9-month follow up. Single- and serial-mediation models were tested. Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes. Reduction in heavy drinking mediated the effect of MI on frequency of sex under the influence (SUI). Further, the effect of MI on condomless sex was mediated by an indirect path in which reductions in heavy drinking at 3 months predicted less SUI at 6 months, which in turn predicted reduction in condomless sex at 9-months. Although some effect of dual-target MI on risky sex is independent of drinking, treatment-related reduction in heavy drinking does account for a significant portion of reduction in risky sex, providing support for the utility of this intervention in patient populations where heavy drinking and risky sex co-occur. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes.",['Patients in Emergency Departments who screened positive for heavy drinking and risky sex'],"['dual-target motivational intervention (MI', 'MI or brief advice']","['heavy drinking and risky sex', 'postintervention RTC and self-efficacy', 'RTC and self-efficacy', 'risky sex', 'Alcohol use and sexual behavior']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0148183,"Patients who received MI had higher postintervention RTC and self-efficacy, but neither mechanism mediated the effects of MI on behavioral outcomes.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Celio', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, State University of New York.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000461']
424,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
425,30918313,Effects of aqueous suppressants and prostaglandin analogues on early wound healing after glaucoma implant surgery.,"A hypertensive phase frequently develops in the early postoperative period after glaucoma shunt operations. Anti-glaucoma eye drop use is essential when postoperative intraocular pressure (IOP) is not controlled. We investigated whether the use of early topical anti-glaucoma medication affects wound healing following glaucoma tube surgery. Eyes were randomly assigned to receive topical aqueous suppressant (timolol-dorzolamide fixed combination), prostaglandin (PG) analogue (travoprost), or normal saline (control group). First, we observed the effects of topical eye drops on Tenon's tissue in non-operated eyes in rabbits. Second, we examined the effects of these eye drops on rabbit eyes that underwent Ahmed glaucoma drainage device implantation, including the effects on the histopathological appearance of their blebs. Interleukin-2 in the Tenon's tissue was elevated in the PG group when compared to the control and aqueous suppressant groups (P = 0.006). In non-operated eyes, IOP was similar among the groups (P = 0.545). After glaucoma implant surgery, the average height of the inner collagenous layer and the average height of the α-SMA-positive blebs were the least in the aqueous suppressant group (P = 0.013, P = 0.001, respectively) at 4 weeks postoperatively. IOP was lower in the aqueous suppressant group than that in the control and PG groups (P = 0.001) following tube surgery. After Ahmed tube surgery, early treatment with aqueous suppressant decreased fibrosis in the bleb, but early treatment with the PG analogues did not.",2019,Interleukin-2 in the Tenon's tissue was elevated in the PG group when compared to the control and aqueous suppressant groups (P = 0.006).,"['after glaucoma implant surgery', 'non-operated eyes in rabbits', 'glaucoma tube surgery']","['topical eye drops', 'early topical anti-glaucoma medication', 'glaucoma drainage device implantation', 'aqueous suppressants and prostaglandin analogues', 'topical aqueous suppressant (timolol-dorzolamide fixed combination), prostaglandin (PG) analogue (travoprost), or normal saline (control group']","['early wound healing', 'IOP', 'wound healing', 'average height of the inner collagenous layer and the average height of the α-SMA-positive blebs', 'postoperative intraocular pressure (IOP']","[{'cui': 'C0395442', 'cui_str': 'Glaucoma tube shunt'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0181041', 'cui_str': 'Aqueous Shunts'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0165590', 'cui_str': 'dorzolamide'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439689', 'cui_str': 'Collagenous (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",,0.061808,Interleukin-2 in the Tenon's tissue was elevated in the PG group when compared to the control and aqueous suppressant groups (P = 0.006).,"[{'ForeName': 'Kyoung In', 'Initials': 'KI', 'LastName': 'Jung', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Woo', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chan Kee', 'Initials': 'CK', 'LastName': 'Park', 'Affiliation': ""Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. ckpark@catholic.ac.kr.""}]",Scientific reports,['10.1038/s41598-019-41790-1']
426,31987796,"Synbiotics Alter Fecal Microbiomes, But Not Liver Fat or Fibrosis, in a Randomized Trial of Patients With Nonalcoholic Fatty Liver Disease.","BACKGROUND & AIMS


Dysbiosis of the intestinal microbiota has been associated with nonalcoholic fatty liver disease (NAFLD). We investigated whether administration of a synbiotic combination of probiotic and prebiotic agents affected liver fat content, biomarkers of liver fibrosis, and the composition of the fecal microbiome in patients with NAFLD.
METHODS


We performed a double-blind phase 2 trial of 104 patients with NAFLD in the United Kingdom. Participants (mean age, 50.8 ± 12.6 years; 65% men; 37% with diabetes) were randomly assigned to groups given the synbiotic agents (fructo-oligosaccharides, 4 g twice per day, plus Bifidobacterium animalis subspecies lactis BB-12; n = 55) or placebo (n = 49) for 10-14 months. Liver fat content was measured at the start and end of the study by magnetic resonance spectroscopy, and liver fibrosis was determined from a validated biomarker scoring system and vibration-controlled transient elastography. Fecal samples were collected at the start and end of the study, the fecal microbiome were analyzed by 16S ribosomal DNA sequencing.
RESULTS


Mean baseline and end-of-study magnetic resonance spectroscopy liver fat percentage values were 32.3% ± 24.8% and 28.5% ± 20.1% in the synbiotic group and 31.3% ± 22% and 25.2% ± 17.2% in the placebo group. In the unadjusted intention-to-treat analysis, we found no significant difference in liver fat reduction between groups (β = 2.8; 95% confidence interval, -2.2 to 7.8; P = .30). In a fully adjusted regression model (adjusted for baseline measurement of the outcome plus age, sex, weight difference, and baseline weight), only weight loss was associated with a significant decrease in liver fat (β = 2; 95% confidence interval, 1.5-2.6; P = .03). Fecal samples from patients who received the synbiotic had higher proportions of Bifidobacterium and Faecalibacterium species, and reductions in Oscillibacter and Alistipes species, compared with baseline; these changes were not observed in the placebo group. Changes in the composition of fecal microbiota were not associated with liver fat or markers of fibrosis.
CONCLUSIONS


In a randomized trial of patients with NAFLD, 1 year of administration of a synbiotic combination (probiotic and prebiotic) altered the fecal microbiome but did not reduce liver fat content or markers of liver fibrosis. (ClinicalTrials.gov, Number: NCT01680640).",2020,"In the unadjusted intention to treat analysis, we found no significant difference in liver fat reduction between groups (β=2.8; 95% CI, -2.2 to 7.8; P=.30).","['Participants (mean age', 'Patients With Non-alcoholic Fatty Liver Disease', '104 patients with NAFLD in the United Kingdom', 'y; 65% men; 37% with diabetes', 'patients with NAFLD, 1 y administration of a', 'patients with NAFLD']","['placebo', 'synbiotic agents (fructo-oligosaccharides, 4 g twice per day, plus Bifidobacterium animalis subsp', 'synbiotic combination of probiotic and prebiotic agents', 'synbiotic combination (probiotic and prebiotic']","['Bifidobacterium and Faecalibacterium, and reductions in Oscillibacter and Alistipes', 'composition of fecal microbiota', 'weight loss', 'liver fat reduction', 'liver fat', 'liver fat or markers of fibrosis', 'liver fat content, biomarkers of liver fibrosis, and the composition of the fecal microbiome', 'Liver fat content', 'Liver Fat or Fibrosis', 'liver fat content or markers of liver fibrosis']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2288424', 'cui_str': 'Oscillibacter species'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]",104.0,0.339403,"In the unadjusted intention to treat analysis, we found no significant difference in liver fat reduction between groups (β=2.8; 95% CI, -2.2 to 7.8; P=.30).","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scorletti', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Department of Gastroenterology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: e.scorletti@soton.ac.uk.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Afolabi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Debbie E', 'Initials': 'DE', 'LastName': 'Smith', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Almehmadi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Albandri', 'Initials': 'A', 'LastName': 'Alshathry', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Childs', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Del Fabbro', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bilson', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Moyses', 'Affiliation': 'National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Geraldine F', 'Initials': 'GF', 'LastName': 'Clough', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jaswinder K', 'Initials': 'JK', 'LastName': 'Sethi', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Institute for Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Janisha', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Hepatology, Department of Medicine, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Hepatology, Department of Medicine, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Breen', 'Affiliation': 'Department of Radiology, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peebles', 'Affiliation': 'Department of Radiology, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Darekar', 'Affiliation': 'Department of Medical Physics, University Hospital Southampton National Health Service (NHS) Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aspinall', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fowell', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Dowman', 'Affiliation': 'Department of Hepatology, Portsmouth Hospitals National Health Service (NHS) Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Nobili', 'Affiliation': 'Hepatology, Gastroenterology and Nutrition Unit, Istituto di Ricovero e Cura a Carattere Scientifico ""Bambino Gesù"" Children\'s Hospital, Rome, Italy; Department of Pediatric, University ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Targher', 'Affiliation': 'Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Laure B', 'Initials': 'LB', 'LastName': 'Bindels', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom; Institute for Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Byrne', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.'}]",Gastroenterology,['10.1053/j.gastro.2020.01.031']
427,32020731,Impact of baseline characteristics on glycemic effects of add-on saxagliptin or acarbose to metformin therapy: Subgroup analysis of the SMART study in Chinese patients with type 2 diabetes mellitus.,"AIMS/INTRODUCTION


This secondary analysis of the 24-week SMART study examined the efficacy of add-on saxagliptin or acarbose to metformin across different patient subgroups with type 2 diabetes mellitus, based on baseline characteristics.
MATERIALS AND METHODS


Randomized patients (n = 481) were classified into subgroups based on their baseline age (<65, ≥65 years), body mass index (BMI; <24, 24-<28, ≥28 kg/m 2  ), glycated hemoglobin (HbA1c; <8%, 8-<9%, 9-<10%, ≥10%) and renal function (creatinine clearance 50-<80, ≥80 mL/min). Treatment effects on primary outcome (HbA1c) and key secondary outcomes of fasting plasma glucose (FPG), 2-h postprandial glucose and homeostatic model assessment of β-cell function were assessed across patient subgroups.
RESULTS


For saxagliptin, reductions in HbA1c from baseline to week 24 were consistent across different subgroups regardless of baseline age, body mass index, HbA1c and renal function (range -0.66 to -1.16%). Saxagliptin was associated with consistent reductions in FPG (-0.60 to -1.33 mmol/L) and 2-h postprandial glucose (-0.48 to -1.95 mmol/L) across the majority of subgroups studied. The efficacy of acarbose on FPG attenuated progressively with increasing baseline HbA1c (+0.86 to -1.43 mmol/L); an increase from baseline FPG was observed in patients with HbA1c >9%. The effect of acarbose on postprandial glucose was also variable (+0.23 to -3.38 mmol/L).
CONCLUSIONS


As add-on to metformin, both saxagliptin and acarbose reduced HbA1c regardless of baseline HbA1c, age, body mass index and renal function; however, only saxagliptin was effective at a stable glycemic control (FPG and PPG). The efficacy of acarbose on FPG and PPG was significantly attenuated in patients with higher baseline HbA1c (≥8%).",2020,The efficacy of acarbose on FPG and PPG was significantly attenuated in patients with higher baseline HbA1c (≥8%).,"['patient subgroups with type 2 diabetes mellitus (T2DM', 'Randomized patients (N=481) were classified into subgroups based on their baseline age (<65, ≥65 years), body mass index (BMI; <24, 24-<28, ≥28Kg/m 2  ), glycated hemoglobin (HbA1c; <8%, 8-<9%, 9-<10%, ≥10%), and renal function (creatinine clearance 50-<80, ≥80mL/min', 'Chinese patients with type 2 diabetes mellitus', 'patients with higher baseline HbA1c (≥8']","['saxagliptin or acarbose to metformin', 'Saxagliptin', 'acarbose', 'metformin therapy', 'saxagliptin or acarbose', 'saxagliptin', 'saxagliptin and acarbose']","['FPG', 'glycemic effects', 'baseline FPG', 'FPG and PPG', 'FPG attenuated progressively with increasing baseline HbA1c', 'primary outcome (HbA1c) and key secondary outcomes of fasting plasma glucose (FPG), 2-hour postprandial glucose (2h-PPG), and homeostatic model assessment of β-cell function', 'PPG', 'BMI, HbA1c, and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",481.0,0.0638924,The efficacy of acarbose on FPG and PPG was significantly attenuated in patients with higher baseline HbA1c (≥8%).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Hebi Coal (Group) Co. Ltd, General Hospital, Hebi, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology, People's Hospital of Liaoning Province, Shenyang, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Geriatrics, Wuhan 6th Hospital, Wuhan, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Jinzhou Central Hospital, Jinzhou, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Chinese People's Armed Police Force General Hospital, Beijing, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Bian', 'Affiliation': ""Department of Endocrinology, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': ""Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, China.""}]",Journal of diabetes investigation,['10.1111/jdi.13224']
428,31808538,Serratus plane block for video-assisted thoracoscopic surgery major lung resection: a randomized controlled trial.,"OBJECTIVES


The aim of this study was to evaluate the impact of 2 different analgesic approaches on pain, postoperative rehabilitation exercises and rescue analgesics of 2 groups of patients undergoing video-assisted thoracoscopic surgery (VATS) major lung resection for cancer.
METHODS


A total of 94 patients undergoing a VATS major lung resection were randomly allocated to 2 groups: the control group received intravenous and oral (i.e. systemic) analgesics while the intervention group received systemic analgesics plus pre-emptive serratus plane block. Pain perception was recorded until drainage removal or until 2 p.m. of postoperative day (POD) 3. In particular, the primary end point was defined as the peak pain perception on POD 1 (in the time frame between 6 a.m. and 2 p.m.). Secondary end points were the number of forced inspiration manoeuvers during rehabilitative incentive spirometry on POD 1 and 2 and the overall number of rescue analgesics requested by patients.
RESULTS


Serratus plane block provided a better pain control between 6 a.m. and 2 p.m. of POD 1 (Numeric Rating Scale 1.7 vs 3.5; P < 0.001). Patients in the intervention group performed more forced inspiration manoeuvers at a mean higher volume during incentive spirometry (8.9 vs 7, P < 0.001, and 1010 vs 865 ml, P = 0.02). They required fewer rescue doses of analgesics (0.57 vs 1.1; P = 0.008).
CONCLUSIONS


Serratus plane block provided a better pain control, entailing a better performance during postoperative rehabilitation exercises in terms of duration and quality of incentive spirometry. It diminished the patient's need for rescue analgesics during the early postoperative period.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03134729.",2020,"They required fewer rescue doses of analgesics (0.57 vs 1.1; P = 0.008).
","['94 patients undergoing a VATS major lung resection', '2 groups of patients undergoing']","['control group received intravenous and oral (i.e. systemic) analgesics while the intervention group received systemic analgesics plus pre-emptive serratus plane block', 'video-assisted thoracoscopic surgery (VATS) major lung resection', 'video-assisted thoracoscopic surgery major lung resection']","['forced inspiration manoeuvers', 'peak pain perception', 'duration and quality of incentive spirometry', 'number of forced inspiration manoeuvers during rehabilitative incentive spirometry on POD 1 and 2 and the overall number of rescue analgesics requested by patients', 'pain control', 'Pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry (regime/therapy)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",94.0,0.208643,"They required fewer rescue doses of analgesics (0.57 vs 1.1; P = 0.008).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Viti', 'Affiliation': 'Thoracic Surgery, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Bertoglio', 'Affiliation': 'Thoracic Surgery, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Zamperini', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Therapy, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Tubaro', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Therapy, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Menestrina', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Therapy, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bonadiman', 'Affiliation': 'Respiratory Rehabilitation Service, Rehabilitation Department, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Avesani', 'Affiliation': 'Respiratory Rehabilitation Service, Rehabilitation Department, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Guerriero', 'Affiliation': 'Clinical Research Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Terzi', 'Affiliation': 'Thoracic Surgery, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz289']
429,32402773,The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation.,"PURPOSE


This study aimed to determine the effect of cold vapor and ice cube absorption in the early postoperative period on sore throat and hoarseness induced by intubation.
DESIGN


This is a randomized controlled experimental study.
METHODS


Four groups (n = 30) were involved in the study: cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application (group 3), and a control group (group 4). The sample consisted of 120 participants. The data were collected using the visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours.
FINDINGS


After the interventions, the mean VAS scores for sore throat at the sixth postoperative hour were found to be 1.50 ± 1.71, 1.16 ± 1.08, and 1.30 ± 1.62 in group 1, group 2, and group 3, respectively. The mean VAS score for sore throat of group 4 was found to be 3.70 ± 1.89. The decrease in the VAS score for the sixth postoperative hour was ranked from highest to lowest as follows: ice cube absorption group, ice cube absorption along with cold vapor application group, and cold vapor application group. There was no significant difference between application groups in terms of mean VAS scores; however, it was found that mean VAS scores of all application groups were lower than that of control group, and there was a significant difference between them (P < .05). We found that at the sixth postoperative hour after intervention, 33.3% of group 1, 36.7% of group 2, 30% of group 3, and 46.7% of group 4 had hoarseness. No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
CONCLUSIONS


Cold vapor application, ice cube absorption, and ice cube absorption along with cold vapor application were effective in reducing sore throat but were ineffective as treatment for hoarseness.",2020,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","['Four groups (n\xa0= 30) were involved in the study', 'Sore Throat and Hoarseness Induced by Intubation', '120 participants', 'sore throat and hoarseness induced by intubation']","['cold vapor and ice cube absorption', 'cold vapor application (group 1), ice cube absorption (group 2), ice cube absorption along with cold vapor application', 'Cold Vapor and Ice Cube Absorption']","['VAS score', 'hoarseness', 'hoarseness scores', 'mean VAS scores', ""visual analog scale (VAS) and Stout's hoarseness scale postextubation (zeroth hour) and at the second, sixth, and 24th hours"", 'mean VAS score']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0452470', 'cui_str': 'Stout'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}]",120.0,0.0248688,"No significant difference was found between groups, in terms of hoarseness scores of patients in the sixth postoperative hour after intervention (P > .05).
","[{'ForeName': 'Muazzez', 'Initials': 'M', 'LastName': 'Şahbaz', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Aydın Adnan Menderes University, Aydın, Turkey. Electronic address: muazzez_sahbaz@hotmail.com.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Khorshid', 'Affiliation': 'Department of Fundamentals of Nursing, Nursing Faculty, Ege University, İzmir, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.007']
430,32207134,"Comparison of Safety and Efficiency of General, Spinal and Epidural Anesthesia Methods Used for the Endoscopic Surgical Treatment of Ureteral Stones: Which One is Better To Access The Ureter and Reach The Stone?","PURPOSE


The aim of this study is to evaluate the effects of anesthesia methods on the success of urethral access and stone access achievement in endoscopic treatment of urolithiasis.
MATERIALS AND METHODS


In this prospective randomized study, 105 patients who underwent primary ureterorenoscopy (URS) procedure for ureteral stones were evaluated. The patients were randomized into three groups by permuted block randomization according to the applied anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA): 31 patients. Ten patients, whose ureteral access was not successful, were dropped out. The success of the three anesthesia methods on the success of the ureter access and its effects on surgical outcomes were compared.
RESULTS


There was no statistically significant difference among the three groups in terms of the demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status. Dilatation and the access time to stone were statistically significantly longer in SA and EA group compared to the GA group. There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates. The Visual Analog Scale (VAS) scores in the 8th and 24th hours were statistically significantly higher in the GA group.
CONCLUSION


In patients who decided to undergo primary ureterorenoscopy procedure, it can be suggested to treat with GA to provide a better relaxation of the ureter if there are no contraindications.",2020,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","['Ureteral Stones', '105 patients who underwent primary URS procedure for ureteral stones were evaluated']","['anesthesia method: General anesthesia (GA): 33 patients, Spinal anesthesia (SA): 31 patients, and Epidural anesthesia (EA']","['Visual Analog Scale (VAS) scores', 'operation, lithotripsy time, stone-free rate (SFR), and complication rates', 'demographic values and preoperative features except the American Society of Anesthesiologists (ASA) status', 'Dilatation and the access time to stone']","[{'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",105.0,0.0339014,"There was no statistically significant difference among the groups in terms of operation, lithotripsy time, stone-free rate (SFR), and complication rates.","[{'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Oztekin', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY. dr_unal@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Caniklioglu', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atac', 'Affiliation': 'Kırıkkale University, Faculty of Medicine, Department of Urology, Kırıkkale, TURKEY.'}, {'ForeName': 'Cigdem Unal', 'Initials': 'CU', 'LastName': 'Kantekin', 'Affiliation': 'Yozgat Bozok University, Faculty of Medicine, Department of Anesthesiology, Yozgat, TURKEY.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gurel', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Isikay', 'Affiliation': 'Yozgat Bozok Unıversity, Faculty of Medicine, Department of Urology, Yozgat, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.5638']
431,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z']
432,32404076,The effects of gamification on antimicrobial resistance knowledge and its relationship to dentistry in Saudi Arabia: a randomized controlled trial.,"BACKGROUND


Antimicrobial resistance (AMR) has reached alarming levels and is considered to be a worldwide public health problem. One of the most significant factors contributing to the spread of AMR is the lack of proper knowledge about the use of antibiotics, which are being used more frequently in dentistry. Recent studies have found that gamification shows promising results for helping the average person improve their knowledge about health and may also be used to boost knowledge about AMR among the public. This study aimed to assess the effects of gamification on AMR awareness, using a board game to promote knowledge about AMR among the public in Saudi Arabia.
METHODS


Using a single-blinded parallel group randomized controlled trial design, 94 volunteers were recruited and randomized into two groups. The study group received information about AMR by playing a board game, while the control group received the same information given in a conventional lecture. The participants were evaluated three times: (T1) before the intervention, (T2) immediately after the intervention, and (T3) one month after the intervention for follow-up to evaluate their retention of the information.
RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups. However, the knowledge scores also relapsed significantly from T2 to T3 in both groups. Nevertheless, the difference in knowledge score T1 to T3 was significantly higher in the study group in comparison to the control group, and the participants had higher mean scores to use the game as health promotion method.
CONCLUSIONS


Gamification using a board game can significantly improve AMR knowledge, with better retention than conventional lecture. It is a promising method for boosting public knowledge about AMR and its relationship to dentistry.
TRIAL REGISTRATION


ISRCTN registry: ISRCTN15884410 (retrospectively registered 26-October-2019).",2020,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","['Saudi Arabia', '94 volunteers']","['information about AMR by playing a board game, while the control group received the same information given in a conventional lecture']","['knowledge score T1 to T3', 'knowledge scores', 'AMR knowledge']","[{'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",94.0,0.0755879,"RESULTS


Results showed that there were significant improvements (p <  0.05) in knowledge scores for T2 and T3 in comparison to the T1 baseline scores in both groups.","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aboalshamat', 'Affiliation': 'Dental Public Health Division, Preventative Dentistry Department, College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia. ktaboalshamat@uqu.edu.sa.'}, {'ForeName': 'Amjad', 'Initials': 'A', 'LastName': 'Khayat', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ragheb', 'Initials': 'R', 'LastName': 'Halwani', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Bitan', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Ryyan', 'Initials': 'R', 'LastName': 'Alansari', 'Affiliation': 'College of Dentistry, Umm Al-Qura University, Makkah, Saudi Arabia.'}]",BMC public health,['10.1186/s12889-020-08806-2']
433,32404088,"The effect of health education on knowledge and behavior toward respiratory infectious diseases among students in Gansu, China: a quasi-natural experiment.","BACKGROUND


The respiratory infectious diseases (RID) threaten the health and life quality of school students. However, previous related studies were insufficient in research design and method applied. This study aimed to evaluate the effect of health education on the knowledge and behavior of students toward RID through difference-in-difference (DID) analysis in Gansu, China.
METHODS


In 2015-2016, a one-year health education program in Gansu, China was conducted. The intervention group contained 1064 students before and 1001 students after the health education (2015 and 2016, respectively). The control group contained 1018 and 1001 students, respectively. The health education, including playing promotional cartoons, developing lectures, giving out handbook copies and making hand copy and blackboard newspapers, and publicity columns on RID, were conducted monthly from 2015 to 2016 in intervention group. The data were collected before and after the health education program with a questionnaire on the students' knowledge and preventive behaviors regarding RID. The × 2  and t tests were performed to compare the accuracy rate and scores for RID knowledge and behavior of the two groups. DID estimation was conducted to evaluate the effect of health education on RID knowledge and behavior while controlling the non- equilibrium variables.
RESULTS


After the health education program, the accuracy rate and scores of most items in the intervention group were significantly higher than those in the control group (P < 0.05) except for item k9 ""What methods can prevent flu?"". The DID results wherein the demographics- age, nationality, and household register were controlled showed that health education significantly improved the accuracy rate of RID knowledge by 5.2-63.9% for most items, although the accuracy rates of items k2 ""What's the transmission way of the mumps?"" and k9 were significantly decreased by 36.8 and 12.0%. The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"". In addition, the health education also significantly improved the score of behavior toward RID of the sampled students by 138.2% (P < 0.001).
CONCLUSION


The results of this study show that health education seemed to increase the RID knowledge and behavior of students. It is recommended that the health education should be enhanced and popularized in schools of China, and RID transmission routes and prevention methods should attract more attention.",2020,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","['students in Gansu, China', '1064 students before and 1001 students after the health education (2015 and 2016, respectively', 'In 2015-2016, a one-year health education program in Gansu, China was conducted', 'school students']",['health education'],"['score of knowledge', 'accuracy rate and scores of most items', 'score of behavior toward RID', 'accuracy rate of all items of RID behavior', 'accuracy rate and scores for RID knowledge and behavior', 'accuracy rate of RID knowledge', 'knowledge and behavior toward respiratory infectious diseases', 'RID knowledge and behavior of students']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0225614,"The health education significantly improved the score of knowledge by 155.2% (P < 0.001) and the accuracy rate of all items of RID behavior by 2.9-51.5% except for item b3 ""If you have phlegm, how do you usually deal with it?"".","[{'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'China Center for Special Economic Zone Research, Shenzhen University, Shenzhen, 518060, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': ""Administration Office, Shenzhen People's Hospital, Second Clinical Medical College of Jinan University, First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518020, China. fanghq@szhospital.com.""}]",BMC public health,['10.1186/s12889-020-08813-3']
434,32404539,Counteracting effect of verbal ratings of sleepiness on dual task interference.,"The aim of the present study was to demonstrate the effect of verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance. Thirty participants underwent the PVT for 40 min in three experimental conditions: (1) Rating condition, in which they verbally rated subjective sleepiness with Karolinska sleepiness scale, following pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task. The results show that during the first half of the task epoch, alpha power density was lower in the Rating than in the No-rating condition, while performance was not different between the conditions. During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density. These results suggest that performance deterioration could be masked by the arousal effect of the dual task itself. It could also explain why the PVT performance and arousal in EEG sometimes dissociate, particularly in dual task situations.",2020,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.",['Thirty participants underwent the'],"['pure tone sound played every 20 s during PVT, (2) No-rating condition, in which they underwent PVT with the similar sound as the Rating experiment but without the verbal rating task, and (3) Control condition, in which they underwent PVT with a no-sound stimulus and without the verbal rating task', 'PVT']","['alpha power density', 'verbal ratings on arousal in the electroencephalogram (EEG) and psychomotor vigilance test (PVT) performance', 'verbal ratings of sleepiness on dual task interference']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",30.0,0.0278604,"During the second half of the task epoch, performance was better in the Non-rating than in the Rating condition, but no difference in the alpha power density.","[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaida', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Iwaki', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Japan.'}]",Industrial health,['10.2486/indhealth.2020-0005']
435,32404854,Clinical Value of Serum LHPP-associated miR-765 in the Prognosis of Laparoscopic or Open Hepatectomy for Hepatocellular Carcinoma.,"PURPOSE


The current study aims to investigate the effect of tumor suppressor LHPP-associated microRNA (miR)-765 on the prognosis of laparoscopic hepatectomy (LH) or open hepatectomy (OH) for hepatocellular carcinoma (HCC).
MATERIALS AND METHODS


A total of 160 patients with HCC were enrolled and randomly divided into the LH or OH group. According to the operation time, these patients were followed up for 12 months, and the number of deaths and the corresponding death time during the follow-up period were counted.
RESULTS


The authors found that the LHPP gene levels in HCC tissues were lower than that in adjacent normal tissues, whereas miR-765 was overexpressed in HCC tissue. Overexpression of miR-765 promoted the epithelial-mesenchymal transition and proliferation and inhibited apoptosis of HCC through directly downregulating LHPP expression. Serum miR-765 expression level was significantly associated with lymph node metastasis and histologic grading. Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
CONCLUSION


For patients with a low miR-765 level, both LH and OH are available, otherwise, LH is more recommended.",2020,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","['Hepatocellular Carcinoma', '160 patients with HCC', 'hepatocellular carcinoma (HCC']","['laparoscopic hepatectomy (LH) or open hepatectomy (OH', 'LH or OH', 'tumor suppressor LHPP-associated microRNA (miR)-765']","['overall survival rate', 'Serum miR-765 expression level', 'LHPP gene levels in HCC tissues', 'number of deaths and the corresponding death time']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0079427', 'cui_str': 'Antioncogene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}]",160.0,0.0345093,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","[{'ForeName': 'Jingting', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Hyperbaric Oxidation, NanHua Hospital.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital, University of South China.'}, {'ForeName': 'Xiuda', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Department of Urology, Hengyang Hospital, Southern Medical University, Hengyang City, Hunan Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Dunxue', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianzhou', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000808']
436,32199708,"Efficacy of Furosemide, Oral Sodium Chloride, and Fluid Restriction for Treatment of Syndrome of Inappropriate Antidiuresis (SIAD): An Open-label Randomized Controlled Study (The EFFUSE-FLUID Trial).","RATIONALE & OBJECTIVE


First-line therapy for syndrome of inappropriate antidiuresis (SIAD) is fluid restriction. Additional treatment for patients who do not respond to fluid restriction are water restriction with furosemide or water restriction with furosemide and salt supplementation. However, the efficacy of these treatments has never been tested in a randomized controlled study. The objective of this study was to investigate whether, combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation was more effective than fluid restriction alone in the treatment of hyponatremia in SIAD.
STUDY DESIGN


Open-label randomized controlled study.
SETTING & PARTICIPANTS


Patients with serum sodium concentrations ([Na + ]) ≤ 130mmol/L due to SIAD.
INTERVENTION(S)


Random assignment to 1 of 3 groups: fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl). Strictness of fluid restriction (<1,000 or<500mL/d) was guided by the urine to serum electrolyte ratio. Furosemide dosage was 20 to 40mg/d. NaCl supplements were 3g/d. All treatments were continued for 28 days.
OUTCOMES


The primary outcome was change in [Na + ] at days 4, 7, 14, and 28 after randomization.
RESULTS


92 patients were recruited (FR, n=31; FR+FM, n=30; FR+FM+NaCl, n=31). Baseline [Na + ] was 125±4mmol/L, and there were no significant differences between groups. Mean [Na + ] on day 4 in all treatment groups was significantly increased from baseline by 5mmol/L (P<0.001); however, the change in [Na + ] was not significantly different across groups (P=0.7). There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups. Acute kidney injury and hypokalemia (potassium≤3.0mmol/L) were more common in patients receiving furosemide.
LIMITATIONS


Open-label treatment.
CONCLUSIONS


In patients with SIAD, furosemide with NaCl supplement in combination with fluid restriction did not show benefits in correction of [Na + ] compared with treatment with fluid restriction alone. Incidences of acute kidney injury and hypokalemia were increased in patients receiving furosemide.
FUNDING


None.
TRIAL REGISTRATION


Registered at the Thai Clinical Trial Registry with study number TCTR20170629004.",2020,There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups.,"['patients receiving furosemide', 'Syndrome of Inappropriate Antidiuresis (SIAD', 'Patients with serum sodium concentrations ([Na + ])\xa0≤ 130mmol/L due to SIAD', 'patients who do not respond to fluid restriction are water restriction with', '92 patients were recruited (FR, n=31']","['fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl', 'Furosemide, Oral Sodium Chloride, and Fluid Restriction', 'furosemide with NaCl supplement', 'Furosemide', 'combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation', 'furosemide or water restriction with furosemide and salt supplementation']","['Acute kidney injury and hypokalemia\xa0(potassium≤3.0mmol/L', 'acute kidney injury and hypokalemia', 'Mean', 'change in [Na + ', 'percentage of patients or\xa0time to reach [Na + ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",92.0,0.18245,There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups.,"[{'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Krisanapan', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Surachet', 'Initials': 'S', 'LastName': 'Vongsanim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pathomporn', 'Initials': 'P', 'LastName': 'Pin-On', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chidchanok', 'Initials': 'C', 'LastName': 'Ruengorn', 'Affiliation': 'Department of Pharmaceutical Care, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kajohnsak', 'Initials': 'K', 'LastName': 'Noppakun', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand. Electronic address: kajohnsak.noppakun@cmu.ac.th.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.11.012']
437,29985228,Pilates Method Training: Functional and Blood Glucose Responses of Older Women With Type 2 Diabetes.,"Melo, KCB, Araújo, FdS, Cordeiro Júnior, CCM, de Andrade, KTP, and Moreira, SR. Pilates method training: Functional and blood glucose responses of older women with type 2 diabetes. J Strength Cond Res 34(4): 1001-1007, 2020-The objective of this study was to investigate the effect of 12 weeks of the Pilates method on the functional capacity (FC) and glycemic control of older women with type 2 diabetes (T2D). Twenty-two women with T2D were randomized into control (CONTROL: 67.5 ± 6.3 years; 154.7 ± 6.1 cm; 73.5 ± 6.1 kg) and Pilates (PILATES: 65.5 ± 5.5 years; 155.0 ± 4.5 cm; 66.2 ± 5.4 kg) groups, which held sessions of 60 minutes at a frequency of 3 times per week during 12 weeks. Blood glucose was measured before and after sessions in PILATES, as well as in moments of pre, rest, 4, 8, and 12 weeks of the PILATES and CONTROL interventions. The glycated hemoglobin (HbA1c) level before and after 12 weeks of the intervention was evaluated. The general index of the FC (GIFC) was obtained through a battery of tests for older patients with T2D. Analysis of variance detected differences in the GIFC for PILATES vs. CONTROL, respectively, in 4 weeks (30.3 ± 4.6 vs. 34.8 ± 4.9 seconds; p < 0.05), 8 weeks (29.2 ± 4.5 vs. 34.6 ± 4.9 seconds; p < 0.05), and 12 weeks (27.2 ± 4.0 vs. 35.3 ± 4.6 seconds; p < 0.05). PILATES presented a difference in postprandial glycemia pre- vs. 4 and 12 weeks (246.1 ± 58.5 vs. 219.9 ± 59.9 and 207.6 ± 49.1 mg·dl, respectively; p < 0.05), as well as in HbA1c pre- vs. 12 weeks (7.8 ± 1.0 vs. 6.7 ± 0.6%, respectively; p < 0.05). Differences in postprandial glycemia (p < 0.05) were found in PILATES before vs. after sessions, respectively, of 1st-12th (217.1 ± 49.1 vs. 157.9 ± 55.7 mg·dl), 13th-24th (204.5 ± 44.7 vs. 146.3 ± 44.5 mg·dl), and 25th-36th (214.3 ± 40.4 vs. 152.7 ± 52.0 mg·dl). A correlation between postprandial glycemia and GIFC after 12 weeks was detected (r = 0.37; p = 0.04). It is concluded that 12 weeks of the Pilates method induces improvement and relationship in the FC and glycemic control in older women with T2D.",2020,"Differences in postprandial glycemia (p < 0.05) were found in the PILATES before vs. after session, respectively, of the 1st-12th (217.1 ± 49.1 mg·dl vs. 157.9 ± 55.7 mg·dl), 13th-24th (204.5 ± 44.7 mg·dl vs. 146.3 ± 44.5 mg·dl), and 25th-36th (214.3 ± 40.4 mg·dl vs. 152.7 ± 52.0 mg·dl).","['Twenty-two women with T2D', 'older women with type 2 diabetes (T2D', 'Older Women With Type 2 Diabetes', 'older women with type 2 diabetes', 'older women with T2D']",['Pilates method training'],"['postprandial glycemia', 'Functional and blood glucose responses', 'functional capacity (FC) and glycemic control', 'Blood glucose', 'general index of FC (GIFC', 'Melo, KCB, Araújo, FdS, Cordeiro Júnior, CCM, de Andrade, KTP, and Moreira, SR', 'glycated hemoglobin (HbA1c', 'postprandial glycemia and GIFC', 'FC and glycemic control']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",22.0,0.0437283,"Differences in postprandial glycemia (p < 0.05) were found in the PILATES before vs. after session, respectively, of the 1st-12th (217.1 ± 49.1 mg·dl vs. 157.9 ± 55.7 mg·dl), 13th-24th (204.5 ± 44.7 mg·dl vs. 146.3 ± 44.5 mg·dl), and 25th-36th (214.3 ± 40.4 mg·dl vs. 152.7 ± 52.0 mg·dl).","[{'ForeName': 'Karla Cinara Bezerra', 'Initials': 'KCB', 'LastName': 'Melo', 'Affiliation': 'Graduate Program of Physical Education, Federal University of Vale do São Francisco, UNIVASF, PE, Petrolina, Brazil.'}, {'ForeName': 'Flávio de Souza', 'Initials': 'FS', 'LastName': 'Araújo', 'Affiliation': ''}, {'ForeName': 'Claudionor Cícero Mascêna', 'Initials': 'CCM', 'LastName': 'Cordeiro Júnior', 'Affiliation': ''}, {'ForeName': 'Karoline Teixeira Passos', 'Initials': 'KTP', 'LastName': 'de Andrade', 'Affiliation': ''}, {'ForeName': 'Sérgio Rodrigues', 'Initials': 'SR', 'LastName': 'Moreira', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002704']
438,32205274,"Effectiveness of Acupuncture in Dental Surgery: A Randomized, Crossover, Controlled Trial.","OBJECTIVES


The objective of this crossover clinical study was to evaluate the effectiveness of Energy Regulation with Acupuncture in clinical occurrences in impacted lower third molar surgeries.
METHODS


The sample consisted of 22 patients with two impacted third molars, in symmetrical position; divided into two groups: Test Group (TG) with Real Energy Regulation Group and Sham Group (SG) with Acupuncture without Energy Regulation function. The extraction was performed 30 days apart. Energy flow (Ryodoraku Method) and energy regulation performed before extraction were measured. Heart Rate (HR) and Blood Pressure (BP) were evaluated before and after energy regulation and after surgery, residual edema was measured by facial measurements (angle of the mandible to tragus (A-T); angle of the mandible to labial commissure (A-LC); angle of the mandible to the wing of the nose (A-WN); angle of the mandible to the corner of the eye (A-CE); angle of the mandible to the chin (A-C); and mouth opening by the interincisal distance, before and after seven days of surgery. To quantify intraoperative bleeding (ml), blood was aspirated along with the saline solution using a portable vacuum pump adaptor. The amount of saline solution used was subtracted from the final amount of aspirated fluid.
RESULTS


Mean of bleeding was lower in TG (p = 0.0392). There were significant differences between groups in facial distances: A-LC (p = 0.010), A-WN (p = 0.030) and A-C (p = 0.008).
CONCLUSION


Energy regulation with real acupuncture was effective in reducing postoperative residual edema and intraoperative bleeding.",2020,"There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008).","['dental surgery', 'p></o', 'impacted lower third molar surgeries', '22 patients with two impacted third molars, in symmetrical position; divided into two groups']","['Test Group (TG) with Real Energy Regulation Group and Sham Group (SG) with Acupuncture without Energy Regulation function', 'real acupuncture', 'Acupuncture', 'Methods:</span></a><span lang=""EN-US"" style=""fontfamily', 'span><span', 'Aim</span><span lang=""EN-US"" style=""font-family', 'span><span lang=""IT"" style=""font-family', 'Results:</span><span', 'sans-serif;""><o', 'acupuncture']","['facial distances: A-LC', 'postoperative residual edema and intraoperative bleeding.</span><span', 'Heart Rate (HR) and Blood Pressure (BP', 'Energy flow (Ryodoraku Method) and energy regulation', 'Mean of bleeding']","[{'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0394662', 'cui_str': 'Ryodoraku (regime/therapy)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",22.0,0.0223714,"There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008).","[{'ForeName': 'Maria L B', 'Initials': 'MLB', 'LastName': 'Gil', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil. Electronic address: marialubgil@gmail.com.""}, {'ForeName': 'Luide M R F', 'Initials': 'LMRF', 'LastName': 'Marinho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Traumatology, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'de Moraes', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Traumatology, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo S', 'Initials': 'RS', 'LastName': 'Wada', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil.""}, {'ForeName': 'Francisco C', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Department of Physiological Sciences, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Sato', 'Affiliation': 'Pain Clinic, São Paulo, Brazil.'}, {'ForeName': 'Maria L R', 'Initials': 'MLR', 'LastName': 'de Sousa', 'Affiliation': ""Department of Health Sciences and Children's Dentistry, Piracicaba School of Dentistry, State University of Campinas, São Paulo, Brazil. Electronic address: luzsousa@fop.unicamp.br.""}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.063']
439,32205449,"Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial.","BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.
PRIMARY OBJECTIVE


The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.
STUDY HYPOTHESIS


We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.
TRIAL DESIGN


This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.
MAJOR ELIGIBILITY CRITERIA


Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.
PRIMARY ENDPOINT


The primary endpoint is overall survival.
SAMPLE SIZE


To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.
TRIAL REGISTRATION


ClinicalTrials.gov:NCT03772028.",2020,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","['patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5\u2009mm in maximum dimension', 'Patients with resectable umbilical, spleen, or local bowel lesions', 'FIGO stage III epithelial ovarian cancer', '538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer', 'Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery', 'patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery', '538 patients need to be randomized', 'patients who are candidates for primary cytoreductive surgery', 'patients with primary FIGO stage III epithelial ovarian cancer']","['Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC', 'platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'HIPEC', 'HIPEC or no HIPEC']","['recurrence-free and overall survival', 'overall survival', 'overall survival events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",538.0,0.335434,"BACKGROUND


The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Koole', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'van Stein', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biostatistics, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Barton', 'Affiliation': 'Department of Gynaecological Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': 'Queensland Centre for Gynaecological Cancer, Herston, Queensland, Australia.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Gynaecology Oncology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Department of Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Gynaecology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Pierre-Emmanuel', 'Initials': 'PE', 'LastName': 'Colombo', 'Affiliation': 'Department of Surgical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'W J van', 'Initials': 'WJV', 'LastName': 'Driel', 'Affiliation': 'Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands w.v.driel@nki.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001231']
440,30272625,"Resistance Training Performed With Single and Multiple Sets Induces Similar Improvements in Muscular Strength, Muscle Mass, Muscle Quality, and IGF-1 in Older Women: A Randomized Controlled Trial.","Cunha PM, Nunes JP, Tomeleri CM, Nascimento MA, Schoenfeld BJ, Antunes M, Gobbo LA, Teixeira D, and Cyrino ES. Resistance training performed with single and multiple sets induces similar improvements in muscular strength, muscle mass, muscle quality, and IGF-1 in older women: A randomized controlled trial. J Strength Cond Res 34(4): 1008-1016, 2020-The purpose of this study was to compare the effects between single set vs. multiple sets of resistance training (RT) on measures of muscular strength, muscle mass, muscle quality (MQ), and insulin-like growth factor 1 (IGF-1) in untrained healthy older women. Sixty-two older women were randomly assigned to 1 of the 3 groups: single-set RT (SS, n = 21), multiple-sets RT (MS, n = 20), or nontraining control (CG, n = 21). Both training groups performed RT for 12 weeks, using 8 exercises of 10-15 repetitions maximum for each exercise. The SS group performed only 1 set per exercise, whereas MS performed 3 sets. Anthropometry, muscle strength (1RM tests), lean soft tissue (LST), and MQ from upper limbs (UL) and lower limbs (LL), and IGF-1 were measured before and after training. Both training groups showed significant pre-training to post-training increases for UL1RM (SS: 37.1%, MS: 27.3%, CG: -3.0%), LL1RM (SS: 16.3%, MS: 21.7%, CG: -0.7%), ULLST (SS: 7.8%, MS: 8.8%, CG: -1.1%), LLLST (SS: 5.6%, MS: 6.3%, CG: -0.8%), upper-limb muscle quality (SS: 25.2%, MS: 16.7%, CG: -0.2%), lower-limb muscle quality (SS: 10.5%, MS: 15.4%, CG: -3.5%), and IGF-1 (SS: +7.1%, MS: +10.1%, CG: -2.2%). We conclude that both SS and MS produce similar increases in muscular strength, LST, and MQ of upper and lower limbs, and IGF-1 after 12 weeks of RT in untrained older women. Our results suggest that, in the early stages, the RT regardless number of sets is effective for improving muscular outcomes in this population.",2020,"Resistance training performed with single and multiple sets induces similar improvements in muscular strength, muscle mass, muscle quality, and IGF-1 in older women: A randomized controlled trial.","['untrained older women', 'Sixty-two older women', 'untrained healthy older women', 'Older Women', 'older women']","['J Strength Cond Res XX(X', 'LLLST', 'CG', 'resistance training (RT', 'SS and MS']","['muscular strength, muscle mass, muscle quality (MQ), and insulin-like growth factor 1 (IGF-1', 'lower-limb muscle quality', 'muscular strength, LST, and MQ of upper and lower limbs, and IGF-1', 'muscular strength, muscle mass, muscle quality, and IGF-1', 'upper-limb muscle quality', 'Muscular Strength, Muscle Mass, Muscle Quality, and IGF-1', 'LL1RM', 'Anthropometry, muscle strength (1RM tests), lean soft tissue (LST), and MQ from upper limbs (UL) and lower limbs (LL), and IGF-1']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",62.0,0.0142163,"Resistance training performed with single and multiple sets induces similar improvements in muscular strength, muscle mass, muscle quality, and IGF-1 in older women: A randomized controlled trial.","[{'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Exercise Science Department, CUNY Lehman College, Bronx, New York.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Antunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Gobbo', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Denilson', 'Initials': 'D', 'LastName': 'Teixeira', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002847']
441,32060017,Time Course of Normalization of Functional β-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes.,"OBJECTIVE


To assess functional β-cell capacity in type 2 diabetes during 2 years of remission induced by dietary weight loss.
RESEARCH DESIGN AND METHODS


A Stepped Insulin Secretion Test with Arginine was used to quantify functional β-cell capacity by hyperglycemia and arginine stimulation. Thirty-nine of 57 participants initially achieved remission (HbA 1c  <6.5% [<48 mmol/mol] and fasting plasma glucose <7 mmol/L on no antidiabetic drug therapy) with a 16.4 ± 7.7 kg weight loss and were followed up with supportive advice on avoidance of weight regain. At 2 years, 20 participants remained in remission in the study. A nondiabetic control (NDC) group, matched for age, sex, and weight after weight loss with the intervention group, was studied once.
RESULTS


During remission, median (interquartile range) maximal rate of insulin secretion increased from 581 (480-811) pmol/min/m 2  at baseline to 736 (542-998) pmol/min/m 2  at 5 months, 942 (565-1,240) pmol/min/m 2  at 12 months ( P  = 0.028 from baseline), and 936 (635-1,435) pmol/min/m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission). This was comparable to the NDC group (1,016 [857-1,507] pmol/min/m 2 ) by 12 ( P  = 0.064) and 24 ( P  = 0.244) months. Median first-phase insulin response increased from baseline to 5 months (42 [4-67] to 107 [59-163] pmol/min/m 2 ;  P  < 0.0001) and then remained stable at 12 and 24 months (110 [59-201] and 125 [65-166] pmol/min/m 2 , respectively;  P  < 0.0001 vs. baseline) but lower than that of the NDC group (250 [226-429] pmol/min/m 2 ;  P  < 0.0001).
CONCLUSIONS


A gradual increase in assessed functional β-cell capacity occurred after weight loss, becoming similar to that of NDC group participants by 12 months. This result was unchanged at 2 years with continuing remission of type 2 diabetes.",2020,m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission).,"['Type 2 Diabetes', 'A nondiabetic control (NDC) group, matched for age, sex, and weight after weight loss with the intervention group, was studied once', 'Thirty-nine of 57 participants initially achieved remission (HbA 1c  <6.5% [<48 mmol/mol] and fasting plasma glucose <7 mmol/L on no antidiabetic drug therapy) with a 16.4 ± 7.7 kg weight loss and were followed up with supportive advice on avoidance of weight regain', 'type 2 diabetes during 2 years of remission induced by dietary weight loss']",['NDC'],"['functional β-cell capacity', 'Median first-phase insulin response', 'insulin secretion']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",,0.0491014,m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission).,"[{'ForeName': 'Sviatlana V', 'Initials': 'SV', 'LastName': 'Zhyzhneuskaya', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Aribisala', 'Affiliation': 'Computer Science Department, Lagos State University, Lagos, Nigeria.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K. roy.taylor@ncl.ac.uk.'}]",Diabetes care,['10.2337/dc19-0371']
442,31466119,"Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study.","BACKGROUND


Management of chronic hand eczema (CHE) remains a challenge; effective topical treatment is limited to corticosteroids.
OBJECTIVES


To assess the efficacy and safety of a novel, pan-Janus kinase inhibitor (delgocitinib) in patients with CHE.
METHODS


In this randomized, double-blind, phase IIa study, patients with CHE received delgocitinib ointment 30 mg g -1  or vehicle ointment for 8 weeks. The primary end point was the proportion of patients achieving treatment success ['clear'/'almost clear' skin with ≥ 2-point improvement in the Physician's Global Assessment of disease severity (PGA)] at week 8. Secondary end points included Hand Eczema Severity Index (HECSI) score changes and the proportion of patients achieving treatment success on the Patient's Global Assessment of disease severity (PaGA).
RESULTS


Ninety-one patients were randomized. More patients receiving delgocitinib (46%) than vehicle (15%) [odds ratio 4·89, 95% confidence interval (CI) 1·49-16·09; P = 0·009] achieved treatment success (PGA). Adjusted mean HECSI score at week 8 was lower with delgocitinib (13·0) than with vehicle (25·8) (adjusted mean difference -12·88, 95% CI -21·47 to -4·30; P = 0·003). More patients receiving delgocitinib than vehicle achieved treatment success by PaGA, but this did not reach statistical significance. The incidence of adverse events was similar with delgocitinib and vehicle; none led to discontinuation of delgocitinib.
CONCLUSIONS


Delgocitinib ointment was efficacious and well tolerated. As a plateau of efficacy was not observed, a longer treatment period may lead to increased efficacy. Further clinical studies are warranted to confirm these findings in patients with CHE. What's already known about this topic? Chronic hand eczema (CHE) has a significant burden. Few randomized controlled studies have evaluated current treatments for CHE; only limited data are available to inform and guide clinical practice decisions. There is currently an unmet need for efficacious and well-tolerated topical treatment options for patients with CHE. What does this study add? Delgocitinib is a novel, pan-Janus kinase (JAK) inhibitor specific for JAK1, JAK2, JAK3 and tyrosine kinase 2. Topical use of delgocitinib ointment resulted in clearance of CHE after 8 weeks of treatment in a significantly greater number of patients than vehicle; delgocitinib was also well tolerated. Results from this proof-of-concept clinical study suggest that topical delgocitinib may provide therapeutic benefit to patients with CHE with inadequate responses to topical corticosteroids.",2020,"The incidence of adverse events was similar with delgocitinib and vehicle; none led to discontinuation of delgocitinib.
","['patients with chronic hand eczema', 'patients with CHE', 'Ninety-one patients were randomised']","['novel, pan-JAK inhibitor (delgocitinib', 'CHE, delgocitinib ointment', 'topical delgocitinib', 'delgocitinib ointment 30\xa0mg/g or vehicle ointment']","['adverse events', ""Hand Eczema Severity Index (HECSI) score changes and the proportion of patients achieving treatment success on the Patient's Global Assessment of disease severity (PaGA"", ""proportion of patients achieving treatment success ('clear'/'almost clear' skin with ≥2-point improvement in the Physician's Global Assessment of disease severity [PGA"", 'efficacious and well tolerated', 'efficacy/safety', 'treatment success (PGA', 'Adjusted mean HECSI score', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1276092', 'cui_str': 'Chronic hand eczema'}, {'cui': 'C0092271', 'cui_str': 'N-cyclohexyltaurine'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C3854325', 'cui_str': 'JAK Inhibitors'}, {'cui': 'C0092271', 'cui_str': 'N-cyclohexyltaurine'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0239816', 'cui_str': 'Hand eczema (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",91.0,0.451758,"The incidence of adverse events was similar with delgocitinib and vehicle; none led to discontinuation of delgocitinib.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology and Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bauer', 'Affiliation': 'Department of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Elsner', 'Affiliation': 'Department of Dermatology, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mahler', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Molin', 'Affiliation': ""Division of Dermatology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'T S S', 'Initials': 'TSS', 'LastName': 'Nielsen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}]",The British journal of dermatology,['10.1111/bjd.18469']
443,31519480,Glucocorticoid and cortisol hormone in response to honey and honey propolis supplementation in mild stress women.,"OBJECTIVE


This study aimed to assess the response of supplementation of honey and honey propolis to women who experience mild stress.
METHODS


The subjects of 30 people were divided into 3 groups; control, honey, and propolis honey every 10 people per group. All groups were given the same dose of 60g/day for 14 days. Measurements of glucocorticoid and cortisol hormones using Enzyme-Linked Immunosorbent Assay (ELISA) and the difference in cortisol hormone levels before and after the intervention were analyzed by a paired T-test.
RESULTS


Honey and propolis honey group decrease cortisol levels but none of the groups have significant changes. This is reciprocal with the changes in the hormone cortisol, the decrease in glucocorticoid hormone levels in the group given honey is the highest following propolis honey and the control group. However, changes in glucocorticoid hormones in the honey group were statistically significant.
CONCLUSION


Our result confirmed that in women who experience mild stress, honey and honey propolis have the potential to reduce stress-related hormones, that is glucocorticoids and cortisol, this reduction does not have the potential to suppress the immune system.",2020,honey group decrease cortisol levels but none of the groups have significant changes.,"['women who experience mild stress', 'mild stress women', 'subjects of 30 people']",['Glucocorticoid and cortisol hormone'],"['glucocorticoid hormones', 'cortisol levels', 'cortisol hormone levels', 'glucocorticoid hormone levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0195559,honey group decrease cortisol levels but none of the groups have significant changes.,"[{'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Midwifery Department, Graduated School, Hasanuddin University, Indonesia. Electronic address: andinilawati@pasca.unhas.ac.id.'}, {'ForeName': 'Andi Zulkifli', 'Initials': 'AZ', 'LastName': 'Abdullah', 'Affiliation': 'Epidemiology Department, Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Indah', 'Initials': 'I', 'LastName': 'Raya', 'Affiliation': 'Chemistry Faculty, Hasanuddin University, Indonesia.'}, {'ForeName': 'Budiaman', 'Initials': 'B', 'LastName': 'Budiaman', 'Affiliation': 'Agriculture Department, Hasanuddin University, Indonesia.'}, {'ForeName': 'Agussalim', 'Initials': 'A', 'LastName': 'Bukhari', 'Affiliation': 'Medicine Faculty, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.013']
444,32074335,Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life.,"INTRODUCTION


Calmare Scrambler Therapy (ST) interferes with pain signal transmission by using nerve fibers to convey a message of normality to the central nervous system. This prospective, double-blinded, randomized trial had three aims. First, we tried to determine ST's effectiveness in reducing chronic neuropathic pain symptoms and analgesic medication use in military service members, when compared to sham treatment. Next, we examined its effect on reported mental and physical health-related quality of life. Finally, we sought to describe participant perceptions of treatment effectiveness.
MATERIALS AND METHODS


Forty-seven subjects were randomized to receive ten 30-minute active ST or sham treatments. Data were collected at baseline, posttreatment, and 1-month follow-up.
RESULTS


The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment. However, both produced clinically meaningful reductions in pain and improvements in physical health-related quality posttreatment that was sustained at 1-month follow-up. Ninety percent of the blinded sample described the treatment intervention as a partial or complete success.
CONCLUSION


ST is no better than sham treatment in decreasing pain. Yet, patient perceptions of treatment effectiveness are equally important in chronic pain treatment.",2020,"The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment.","['Forty-seven subjects', 'military service members']","['Scrambler Therapy Treatment', 'Calmare Scrambler Therapy (ST']","['Chronic Pain and Quality of Life', 'mental and physical health-related quality of life', 'physical health-related quality posttreatment', 'chronic neuropathic pain symptoms', 'pain scores, medication use, or mental or physical health-related quality of life', 'pain']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",47.0,0.189021,"The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment.","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nayback-Beebe', 'Affiliation': 'U.S. Army Medical Research & Materiel Command, 810 Schreider St., Fort Detrick, MD 21702.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Panula', 'Affiliation': 'U.S. Army Medical Command, 2271 Reynolds Road, Bldg. 4025, Fort Sam Houston, TX 78234.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Arzola', 'Affiliation': 'The Geneva Foundation, 917 Pacific Ave, Tacoma, WA 98402.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Goff', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Fort Sam Houston, TX 78234.'}]",Military medicine,['10.1093/milmed/usz253']
445,32089329,"Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil ☆ .","PURPOSE


Many patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients who require multiple medications, but the number of fixed combinations combining 3 complementary IOP-lowering agents remains limited. This study assessed the efficacy and safety of a triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), compared with a dual fixed combination (DFC) of brimonidine 0.2%/timolol 0.5%.
METHODS


Patients with a baseline IOP of 23-34 mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study. After washout of previous treatment (if applicable), patients were randomized to receive TFC or DFC twice daily in each eye for 3 months. The primary efficacy variable was the change from baseline in mean IOP in the worse eye at week 12 in the modified intent-to-treat (mITT) population. TFC was superior to DFC if the treatment difference (TFC - DFC) favored TFC at week 12 (P ≤ 0.05; 2-sample t test). Secondary and sensitivity analyses were also performed. Safety, including adverse events, was assessed at all visits.
FINDINGS


The mITT/safety population included 185 patients (TFC, n = 90; DFC, n = 95). TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22). While treatment-related conjunctival hyperemia was more frequent with TFC than with DFC (47.8% vs 23.2%; P < 0.001), consistent with the additional presence of bimatoprost in TFC, most cases were mild and the numbers of patient discontinuations at week 12 were similar between the TFC and DFC groups (11 [12.2%] vs 7 [7.4%] patients; P = 0.266). No unexpected adverse events were reported.
IMPLICATIONS


Compared with DFC, TFC provided superior IOP lowering throughout the primary efficacy period. An acceptable tolerability profile was observed through 12 months of use of TFC, offering an effective therapeutic option in patients with POAG or OHT who require multiple medications to control their IOP. Additional studies are required for the assessment of the long-term effects of TFC. ClinicalTrials.gov identifier: NCT01217606.",2020,"TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22).","['patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT', 'patients who require multiple medications', 'patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP', 'Glaucoma', '185 patients (TFC, n\xa0=\xa090; DFC, n\xa0=\xa095', 'Patients with a baseline IOP of 23-34\xa0mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study', 'patients with POAG or OHT who require multiple medications to control their IOP']","['TFC', 'Fixed-combination ophthalmic solutions', 'triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution', 'brimonidine 0.2%/timolol 0.5', 'DFC, TFC', 'TFC or DFC', 'Brimonidine/Timolol']","['mean IOP', 'efficacy and safety', 'acceptable tolerability profile', 'TFC superiority', 'numbers of patient discontinuations', 'adverse events', 'conjunctival hyperemia', 'Safety, including adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C1563133', 'cui_str': 'brimonidine / Timolol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",185.0,0.204619,"TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22).","[{'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Hospital São Paulo, Federal University of São Paulo, São Paulo, Brazil. Electronic address: prof.belfort@clinicabelfort.com.br.'}, {'ForeName': 'Jayter Silva', 'Initials': 'JS', 'LastName': 'Paula', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Medical School, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Marcelo Jordão', 'Initials': 'MJ', 'LastName': 'Lopes Silva', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Medical School, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Della Paolera', 'Affiliation': 'Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.12.008']
446,31791332,Assessing the impact of the addition of pyriproxyfen on the durability of permethrin-treated bed nets in Burkina Faso: a compound-randomized controlled trial.,"BACKGROUND


Long-lasting insecticidal nets (LLINs) treated with pyrethroids are the foundation of malaria control in sub-Saharan Africa. Rising pyrethroid resistance in vectors, however, has driven the development of alternative net formulations. Here the durability of polyethylene nets with a novel combination of a pyrethroid, permethrin, and the insect juvenile hormone mimic, pyriproxyfen (PPF), compared to a standard permethrin LLIN, was assessed in rural Burkina Faso.
METHODS


A compound-randomized controlled trial was completed in two villages. In one village 326 of the PPF-permethrin nets (Olyset Duo) and 327 standard LLINs (Olyset) were distributed to assess bioefficacy. In a second village, 170 PPF-permethrin nets and 376 LLINs were distributed to assess survivorship. Nets were followed at 6-monthly intervals for 3 years. Bioefficacy was assessed by exposing permethrin-susceptible and resistant Anopheles gambiae sensu lato mosquito strains to standard World Health Organization (WHO) cone and tunnel tests with impacts on fertility measured in the resistant strain. Insecticide content was measured using high-performance liquid chromatography. LLIN survivorship was recorded with a questionnaire and assessed by comparing the physical integrity using the proportionate hole index (pHI).
RESULTS


The PPF-permethrin net met WHO bioefficacy criteria (≥ 80% mortality or ≥ 95% knockdown) for the first 18 months, compared to 6 months for the standard LLIN. Mean mosquito mortality for PPF-permethrin nets, across all time points, was 8.6% (CI 2.6-14.6%) higher than the standard LLIN. Fertility rates were reduced after PPF-permethrin net exposure at 1-month post distribution, but not later. Permethrin content of both types of nets remained within the target range of 20 g/kg ± 25% for 242/248 nets tested. The pyriproxyfen content of PPF-permethrin nets declined by 54%, from 10.4 g/kg (CI 10.2-10.6) to 4.7 g/kg (CI 3.5-6.0, p < 0.001) over 36 months. Net survivorship was poor, with only 13% of PPF-permethrin nets and 12% of LLINs still present in the original household after 36 months. There was no difference in the fabric integrity or survivorship between the two net types.
CONCLUSION


The PPF-permethrin net, Olyset Duo, met or exceeded the performance of the WHO-recommended standard LLIN (Olyset) in the current study but both net types failed the 3-year WHO bioefficacy criteria.",2019,"The PPF-permethrin net met WHO bioefficacy criteria (≥ 80% mortality or ≥ 95% knockdown) for the first 18 months, compared to 6 months for the standard LLIN.","['two villages', 'Burkina Faso']","['pyrethroid, permethrin, and the insect juvenile hormone mimic, pyriproxyfen (PPF', 'permethrin-treated bed nets', 'pyriproxyfen']","['Insecticide content', 'LLIN survivorship', 'Fertility rates', 'Mean mosquito mortality', 'Bioefficacy', 'pyriproxyfen content of PPF-permethrin nets', 'fabric integrity or survivorship', 'Net survivorship']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}]","[{'cui': 'C0597329', 'cui_str': 'Pyrethroids'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0981916', 'cui_str': 'insects'}, {'cui': 'C0022439', 'cui_str': 'Insect Growth Regulators'}, {'cui': 'C0139497', 'cui_str': '4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0038955'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0139497', 'cui_str': '4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",,0.0439021,"The PPF-permethrin net met WHO bioefficacy criteria (≥ 80% mortality or ≥ 95% knockdown) for the first 18 months, compared to 6 months for the standard LLIN.","[{'ForeName': 'Kobié H', 'Initials': 'KH', 'LastName': 'Toé', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mechan', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Julie-Anne A', 'Initials': 'JA', 'LastName': 'Tangena', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Morris', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Solino', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Emile F S', 'Initials': 'EFS', 'LastName': 'Tchicaya', 'Affiliation': ""Swiss Centre for Scientific Research in Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Traoré', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Hanafy', 'Initials': 'H', 'LastName': 'Ismail', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maas', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Lissenden', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK.'}, {'ForeName': 'Alfred B', 'Initials': 'AB', 'LastName': 'Tiono', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Ranson', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK. Hilary.Ranson@lstmed.ac.uk.'}, {'ForeName': ""N'Falé"", 'Initials': 'N', 'LastName': 'Sagnon', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.'}]",Malaria journal,['10.1186/s12936-019-3018-1']
447,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
448,32196954,Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.,"Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial. In part 2, the bioavailability of levocetirizine ODT without water was compared with that of levocetirizine IRT with water in the fasted state in 48 subjects; 47 subjects completed this part of the trial. Bioequivalence was demonstrated between levocetirizine IRT 5 mg and ODT 5 mg. The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.",2020,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","['Healthy Japanese Volunteers', '24 subjects', 'healthy Japanese male subjects consisting of 2 parts', '48 subjects; 47 subjects completed this part of the trial']","['levocetirizine ODT and levocetirizine IRT', 'levocetirizine ODT', 'Levocetirizine', 'Levocetirizine Oral Disintegrating Tablet', 'levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT', 'levocetirizine IRT']","['serious adverse events, deaths, or adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.011894,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hoyano', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakano', 'Affiliation': 'Immuno-Inflammation Therapeutic Office, Medicines Development, Japan Development, GlaxoSmithKline KK, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.791']
449,32196976,The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 × 20-mg Capsules in Healthy Volunteers.,"Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20-mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early-stage symptomatic ATTR polyneuropathy. This agent, administered as an 80-mg, once-daily dose (4 × 20-mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild-type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single-center, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61-mg free acid capsules (test) and tafamidis meglumine 80-mg (4 × 20-mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125). Both tafamidis regimens had an acceptable safety/tolerability profile in this population.",2020,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","['30 healthy volunteers', 'adults with early-stage symptomatic ATTR polyneuropathy', 'Healthy Volunteers']","['Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine', 'Tafamidis meglumine']","['acceptable safety/tolerability profile', 'Ratios of adjusted geometric means (90%CI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C2745275', 'cui_str': 'Tafamidis meglumine'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0586977,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lockwood', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Le', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': ""O'Gorman"", 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Terrell A', 'Initials': 'TA', 'LastName': 'Patterson', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Marla B', 'Initials': 'MB', 'LastName': 'Sultan', 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Tankisheva', 'Affiliation': 'Pfizer, Brussels, Belgium.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Pfizer Beijing City, China.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.789']
450,32198095,Effect of Transcutaneous Electrical Nerve Stimulation on the Pain Intensity During Insertion of Needle in Patients Undergoing Spinal Anesthesia: A Randomized Controlled Study.,"BACKGROUND AND OBJECTIVES


Needle insertion pain during spinal anesthesia is an unpleasant experience for patients. This study aimed to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on the pain intensity during the insertion of spinal needles in patients undergoing spinal anesthesia.
MATERIALS AND METHODS


In a double-blind clinical trial, 60 candidates for elective Trans Ureteral Lithotripsy surgery under spinal anesthesia were randomly divided into intervention and control groups. The electrodes of the TENS device were placed in the space between L3-L4 and L5-S1 vertebrae. The intensity of pain during insertion of the spinal needle by Visual Analog Scale and the frequency of attempts were recorded.
RESULTS


The mean age of the study samples was 34.26 ± 5.07 and 32.8 ± 5.28 in the control and intervention group, respectively. The pain intensity during insertion of spinal needles was less significant in the intervention group compared to the control group (p = 0.001). The number of attempts to insert the spinal needle between the two groups was not statistically significant (p = 0.51). The duration of spinal anesthesia implementation procedure by physician in the intervention group was significantly shorter than that of the control group (p = 0.001).
CONCLUSION


The use of TENS effectively reduced the pain of spinal needle insertion. Considering these beneficial effects, it is suggested that this procedure be used to relive pain in patients with spinal anesthesia.",2020,The number of attempts to insert the spinal needle between the two groups was not statistically significant (P = 0.51).,"['patients', 'The study samples were 41.66% female and 58.33% male', 'patients with spinal anesthesia', '60 candidates for elective Trans Ureteral Lithotripsy surgery under spinal anesthesia', 'Patients Undergoing Spinal anesthesia', 'patients undergoing spinal anesthesia, ImamReza hospital in Kermanshah, Iran, in 2018']","['TENS', 'Transcutaneous Electrical Nerve Stimulation (TENS']","['Pain Intensity', 'pain of spinal needle insertion', 'intensity of pain', 'pain intensity', 'duration of implementation spinal anesthesia procedure by physician', 'number of attempts to insert the spinal needle', 'pain intensity during insertion of spinal needles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181982', 'cui_str': 'Spinal needle (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}]",60.0,0.0273415,The number of attempts to insert the spinal needle between the two groups was not statistically significant (P = 0.51).,"[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'AminiSaman', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hasan A', 'Initials': 'HA', 'LastName': 'Karimpour', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hemmatpour', 'Affiliation': 'Department of Nursing, School of Nursing, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Darvishi', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Kawyannejad', 'Affiliation': 'Department of Anesthesia, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Physiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: r.kaviannezhad@kums.ac.ir.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.062']
451,32019855,ACE and Type 2 Diabetes Risk: A Mendelian Randomization Study.,"OBJECTIVE


To determine whether ACE inhibitors reduce the risk of type 2 diabetes using a Mendelian randomization (MR) approach.
RESEARCH DESIGN AND METHODS


A two-sample MR analysis included 17 independent genetic variants associated with ACE serum concentration in 4,147 participants from the Outcome Reduction with Initial Glargine INtervention (ORIGIN) (clinical trial reg. no. NCT00069784) trial, and their effects on type 2 diabetes risk were estimated from 18 studies of the DIAbetes Genetics Replication And Meta-analysis (DIAGRAM) consortium. A genetic risk score (GRS) underpinning lower ACE concentration was then tested for association with type 2 diabetes prevalence in 341,872 participants, including 16,320 with type 2 diabetes, from the UK Biobank. MR estimates were compared after standardization for blood pressure change, with the estimate obtained from a randomized controlled trial (RCT) meta-analysis of ACE inhibitors versus placebo ( n  = 31,200).
RESULTS


Genetically lower ACE concentrations were associated with a lower risk of type 2 diabetes (odds ratio [OR] per SD 0.92 [95% CI 0.89-0.95];  P  = 1.79 × 10 -7 ). This result was replicated in the UK Biobank (OR per SD 0.97 [0.96-0.99];  P  = 8.73 × 10 -4 ). After standardization, the  ACE  GRS was associated with a larger decrease in type 2 diabetes risk per 2.4-mmHg lower mean arterial pressure (MAP) compared with that obtained from an RCT meta-analysis (OR per 2.4-mmHg lower MAP 0.19 [0.07-0.51] vs. 0.76 [0.60-0.97], respectively;  P  = 0.007 for difference).
CONCLUSIONS


These results support the causal protective effect of ACE inhibitors on type 2 diabetes risk and may guide therapeutic decision making in clinical practice.",2020,"RESULTS


Genetically lower ACE concentrations were associated with a lower risk of type 2 diabetes (odds ratio [OR] per SD 0.92","['4,147 participants from the Outcome Reduction with Initial', 'and Type 2 Diabetes Risk', '341,872 participants, including 16,320 with type 2 diabetes, from the UK Biobank']","['ACE inhibitors versus placebo', 'ACE', 'Glargine INtervention', 'ACE inhibitors']",['mean arterial pressure (MAP'],"[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}]",341872.0,0.111132,"RESULTS


Genetically lower ACE concentrations were associated with a lower risk of type 2 diabetes (odds ratio [OR] per SD 0.92","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Pigeyre', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sjaarda', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chong', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': 'R&D, Translational Medicine & Early Development, Biomarkers & Clinical Bioanalyses, Sanofi Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hertzel', 'Initials': 'H', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Paré', 'Affiliation': 'Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Ontario, Canada pareg@mcmaster.ca.'}]",Diabetes care,['10.2337/dc19-1973']
452,32187115,Factors Associated With Cannabis Use Among African American Nondaily Smokers.,"OBJECTIVES


Cannabis and tobacco dual use is a growing concern in the United States, especially among African Americans (AAs). Dual use increases nicotine dependence and poses negative health effects. Despite decreasing numbers of people who smoke daily, nondaily smokers (NDS) are increasing. Polytobacco use, including blunt use, is higher in AA NDS than AAs who smoke daily. This study examined factors associated with cannabis use among AA NDS.
METHODS


Adult AA NDS participated in a randomized controlled trial (n = 278) for smoking cessation. A subset of this sample (n = 262; mean age 48.2 years; 50% male) was analyzed to identify correlates of cannabis use. Logistic regression assessed the associations of demographic, smoking-related, and psychosocial variables with cannabis use.
RESULTS


Participants smoked cigarettes on an average of 18 days of the last 30 and used 4.5 cigarettes on smoking days. Of the participants analyzed, 38% used cannabis, including blunts (ie, cigars hollowed out filled with cannabis) at baseline. Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
CONCLUSIONS


Rates of cannabis and tobacco dual use in our sample exceed national rates. Dual use poses harmful health effects that exceed the risk of either substance alone. Findings will inform future work in tailoring treatments to vulnerable groups of people who use both tobacco and cannabis.",2020,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
","['African Americans (AAs', 'African American Nondaily Smokers', 'Adult AA NDS participated in a randomized controlled trial (n\u200a=\u200a278) for smoking cessation', 'A subset of this sample (n\u200a=\u200a262; mean age 48.2 years; 50% male']",[],['depressive symptoms'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0939808,"Cannabis use was associated with polytobacco product use not including blunts (odds ratio [OR] 2.11, 95% confidence interval [CI] 1.18-3.77, P = 0.012), depressive symptoms (OR 1.22, 95% CI 1.05-1.42, P = 0.011), and younger age (OR 0.97, 95% CI 0.94-0.99, P = 0.004).
","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Rubenstein', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI (DR, ERA, JSA); Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI (ERA, JSA); Department of Population Health, University of Kansas School of Medicine, Kansas City, KS (NLN); Department of Biostatistics & Data Science, University of Kansas School of Medicine, Kansas City, KS (MSM, ARB).'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': ''}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': ''}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000652']
453,32075307,"Effects of A ""Modified"" Otago Exercise Program on the Functional Abilities and Social Participation of Older Adults Living in the Community-The AGA@4life Model.","Strength and balance exercises form part of multifactorial programs to reduce the risk of falling and promote active ageing. The aim of this study was to evaluate the effect of a strength and balance exercise program, adapted from the traditional Otago Exercise Program (OTAGO) into a technological system. A non-randomized experimental study enrolled 34 participants (83.24 ± 6.89 years) from a daycare center in Portugal, who were distributed into an intervention group (IG; 18 participants) and a control group (CG; 16 participants). The IG underwent a ""modified"" OTAGO incorporated in a technological system using pressure and inertial sensors, feedback, and Exergames for 8 weeks, 3 times a week. The CG continued their regular activities. Outcome measures were evaluated at baseline and after 8 weeks of intervention. After the program, differences were observed between the groups in handgrip strength ( p  = 0.03), step test ( p  = 0.03), 4stage balance test ""modified"" ( p  < 0.001) and activities and participation profile related to mobility (PAPM) ( p  < 0.001). The IG showed positive results in the self-efficacy for exercise ( p  = 0.03), PAPM ( p  = 0.00) and all functional tests, except for timed up and go ( p  = 0.35). No significant changes were observed in the CG. The results support this intervention program as a good exercise solution to improve functional abilities, social participation, and self-efficacy, reducing the risk of falling.",2020,"After the program, differences were observed between the groups in handgrip strength ( p  = 0.03), step test ( p  = 0.03), 4stage balance test ""modified"" ( p  < 0.001) and activities and participation profile related to mobility (PAPM) ( p  < 0.001).","['Older Adults Living in the Community-The AGA@4life Model', '34 participants (83.24 ± 6.89 years) from a daycare center in Portugal, who were distributed into an intervention group (IG; 18 participants) and a control group (CG; 16 participants']","['strength and balance exercise program, adapted from the traditional Otago Exercise Program (OTAGO', 'Modified"" Otago Exercise Program']","['functional abilities, social participation, and self-efficacy, reducing the risk of falling', 'risk of falling and promote active ageing', 'activities and participation profile related to mobility (PAPM', 'handgrip strength', 'Functional Abilities and Social Participation', '4stage balance test ""modified', 'PAPM', 'CG']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",34.0,0.0210439,"After the program, differences were observed between the groups in handgrip strength ( p  = 0.03), step test ( p  = 0.03), 4stage balance test ""modified"" ( p  < 0.001) and activities and participation profile related to mobility (PAPM) ( p  < 0.001).","[{'ForeName': 'Anabela Correia', 'Initials': 'AC', 'LastName': 'Martins', 'Affiliation': 'Physiotherapy Department, Coimbra Health School, Polytechnic of Coimbra, 3046-854 Coimbra, Portugal.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Guia', 'Affiliation': 'Physiotherapy Department, Coimbra Health School, Polytechnic of Coimbra, 3046-854 Coimbra, Portugal.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Saraiva', 'Affiliation': 'Physiotherapy Department, Coimbra Health School, Polytechnic of Coimbra, 3046-854 Coimbra, Portugal.'}, {'ForeName': 'Telmo', 'Initials': 'T', 'LastName': 'Pereira', 'Affiliation': 'Clinical Physiology Department, Coimbra Health School, Polytechnic of Coimbra, 3046-854 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17041258']
454,24794367,Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.,"IMPORTANCE


Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole are unknown.
OBJECTIVE


To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants.
DESIGN, SETTING, AND PATIENTS


This study was a randomized, blinded, placebo-controlled trial of fluconazole in premature infants. Infants weighing less than 750 g at birth (N = 361) from 32 neonatal intensive care units (NICUs) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days. Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes. The study was conducted between November 2008 and February 2013.
INTERVENTIONS


Fluconazole (6 mg/kg of body weight) or placebo.
MAIN OUTCOMES AND MEASURES


The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 (1 week after completion of study drug). Secondary and safety outcomes included invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy at 18 to 22 months corrected age.
RESULTS


Among infants receiving fluconazole, the composite primary end point of death or invasive candidiasis was 16% (95% CI, 11%-22%) vs 21% in the placebo group (95% CI, 15%-28%; odds ratio, 0.73 [95% CI, 0.43-1.23]; P = .24; treatment difference, -5% [95% CI, -13% to 3%]). Invasive candidiasis occurred less frequently in the fluconazole group (3% [95% CI, 1%-6%]) vs the placebo group (9% [95% CI, 5%-14%]; P = .02; treatment difference, -6% [95% CI, -11% to -1%]). The cumulative incidences of other secondary outcomes were not statistically different between groups. Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
CONCLUSIONS AND RELEVANCE


Among infants with a birth weight of less than 750 g, 42 days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis. These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00734539.",2014,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","['Infants weighing less than 750 g at birth (N\u2009=\u2009361) from 32 neonatal intensive care units (NICUs) in the United States', 'extremely low-birth-weight infants', 'infants with a birth weight of less than 750 g, 42 days of', 'premature infants', 'November 2008 and February 2013']","['placebo', 'fluconazole or placebo', 'fluconazole', 'prophylactic fluconazole', 'Fluconazole prophylaxis', 'fluconazole prophylaxis', 'Fluconazole']","['cumulative incidences', 'invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy', 'composite of death or definite or probable invasive candidiasis', 'Invasive candidiasis', 'efficacy and safety', 'candidiasis and mortality', 'Neurodevelopmental impairment', 'composite of death or invasive candidiasis', 'death or invasive candidiasis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0023529', 'cui_str': 'Encephalomalacia, Periventricular'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.60973,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","[{'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Duara', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Randolph', 'Affiliation': 'University of Alabama-Birmingham.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Bidegain', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Burchfield', 'Affiliation': 'University of Florida Health Shands Hospital, Gainesville.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'White', 'Affiliation': 'Memorial Hospital South Bend, South Bend, Indiana.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Shattuck', 'Affiliation': 'University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Neu', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bendel', 'Affiliation': ""University of Minnesota Amplatz Children's Hospital, Minneapolis.""}, {'ForeName': 'M Roger', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Brookdale University Hospital, Brooklyn, New York.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': 'University of California-San Diego Medical Center.'}, {'ForeName': 'Dan L', 'Initials': 'DL', 'LastName': 'Stewart', 'Affiliation': 'University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""Sant'Anna Hospital, Turin, Italy.""}, {'ForeName': 'Kristi O', 'Initials': 'KO', 'LastName': 'Prather', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Testoni', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Berezny', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.2624']
455,31884854,"Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.","While hypertension and inflammation are physiologically inter-related, the effect of therapies that specifically target inflammation on blood pressure is uncertain. The recent CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) afforded the opportunity to test whether IL (interleukin)-1β inhibition would reduce blood pressure, prevent incident hypertension, and modify relationships between hypertension and cardiovascular events. CANTOS randomized 10 061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg/L to canakinumab 50 mg, 150 mg, 300 mg, or placebo. A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension. In patients without baseline hypertension, rates of incident hypertension were 23.4, 26.6, and 28.1 per 100-person years for the lowest to highest baseline tertiles of hsCRP ( P >0.2). In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2). IL-1β inhibition with canakinumab reduces major adverse cardiovascular event rates. These analyses suggest that the mechanisms underlying this benefit are not related to changes in blood pressure or incident hypertension. Clinical Trial Registration- URL: https://clinicaltrials.gov. Unique identifier: NCT01327846.",2020,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","['061 patients with prior myocardial infarction and hsCRP (high sensitivity C-reactive protein) ≥2 mg', 'A total of 9549 trial participants had blood pressure recordings during follow-up; of these, 80% had a preexisting diagnosis of hypertension']","['L to canakinumab 50 mg, 150 mg, 300 mg, or placebo', 'Interleukin-1β Inhibition', 'IL (interleukin)-1β inhibition']","['Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk', 'blood pressure or incident hypertension', 'rates of incident hypertension', 'incident hypertension', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.224736,"In all participants random allocation to canakinumab did not reduce blood pressure ( P >0.2) or incident hypertension during the follow-up period (hazard ratio, 0.96 [0.85-1.08],  P >0.2).","[{'ForeName': 'Alexander Mk', 'Initials': 'AM', 'LastName': 'Rothman', 'Affiliation': 'From the Department of Cardiology, Chesterman Cardiothoracic Unit, Northern General Hospital, Sheffield, United Kingdom (A.M.K.R.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover, NJ (T.T.).'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Department of Clinical Neurosciences, University of Oxford, United Kingdom (A.W.).'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Harrison', 'Affiliation': 'Vanderbilt University, Nashville, TN (D.G.H.).'}, {'ForeName': 'Tomasz J', 'Initials': 'TJ', 'LastName': 'Guzik', 'Affiliation': 'Institute of Cardiovascular and Medical Research, Queen Elizabeth University Hospital, University of Glasgow (T.J.G.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division (P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention (J.M., R.J.G., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13642']
456,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
457,31444692,Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors.,"Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.",2020,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","['Stroke Survivors', 'Chronic stroke survivors', 'Twenty-five participants completed the study', 'chronic stroke survivors']",['Peripheral sensory stimulation'],"['worsened sensory scores', 'Device-related AE rates', 'worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}]",25.0,0.393901,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","[{'ForeName': 'Na Jin', 'Initials': 'NJ', 'LastName': 'Seo', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, Department of Health Sciences and Research, Medical University of South Carolina (MUSC), Charleston, SC, USA. seon@musc.edu.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Enders', 'Affiliation': 'TheraBracelet Inc., Louisville, KY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fortune', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Cain', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Vatinno', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schuster', 'Affiliation': 'Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}]",Translational stroke research,['10.1007/s12975-019-00724-9']
458,31831574,Reducing weight and increasing physical activity in people at high risk of cardiovascular disease: a randomised controlled trial comparing the effectiveness of enhanced motivational interviewing intervention with usual care.,"OBJECTIVE


The epidemic of obesity is contributing to the increasing prevalence of people at high risk of cardiovascular disease (CVD), negating the medical advances in reducing CVD mortality. We compared the clinical and cost-effectiveness of an intensive lifestyle intervention consisting of enhanced motivational interviewing in reducing weight and increasing physical activity for patients at high risk of CVD.
METHODS


A three-arm, single-blind, parallel-group randomised controlled trial was conducted in consenting primary care centres in south London. We recruited patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years. The intervention was enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers in 10 sessions over 1 year, in either group (n=697) or individual (n=523) format. The third arm received usual care (UC; n=522). The primary outcomes were physical activity (mean steps/day) and weight (kg). Secondary outcomes were changes in low-density lipoprotein cholesterol and CVD risk score. We estimated the relative cost-effectiveness of each intervention.
RESULTS


At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes. The group and individual interventions were not cost-effective at conventional thresholds.
CONCLUSIONS


Enhancing motivational interviewing with additional behaviour change techniques was not effective in reducing weight or increasing physical activity in those at high CVD risk.",2020,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","['patients at high risk of CVD', 'patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years', 'people at high risk of cardiovascular disease', 'consenting primary care centres in south London']","['enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers', 'intensive lifestyle intervention consisting of enhanced motivational interviewing', 'enhanced motivational interviewing intervention with usual care']","['physical activity', 'weight or increasing physical activity', 'low-density lipoprotein cholesterol and CVD risk score', 'weight and increasing physical activity', 'physical activity (mean steps/day) and weight (kg', 'Reducing weight and increasing physical activity', 'reducing weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.148609,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","[{'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK khalida.2.ismail@kcl.ac.uk.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Twist', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Cook', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Health Services and Population Research, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, King's College London, London, UK.""}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315656']
459,32192688,Radiofrequency Ablation of the Surgical Bed After Lumpectomy in Breast-conserving Surgery.,"INTRODUCTION


Obtaining tumor-free margins during breast conservative surgery (BCS) is essential to avoid local recurrence and frequently requires reoperation. Radiofrequency ablation (RFA) of surgical margins after lumpectomy seems to be a helpful tool to avoid reoperations, but evidence is insufficient. This study analyzes the efficacy and safety of RFA after BCS to obtain free surgical margins.
METHODS


Non-randomized experimental study performed in an intervention group of 40 patients assigned to receive RFA after lumpectomy and successive resection of surgical margins, and a historical control group of 40 patients treated with BCS alone. In the intervention group, the RFA effect on tumor cell viability in the surgical margins was analyzed. Also, reoperation rate, complications and cosmetic results were compared in both groups.
RESULTS


A total of 240 excised margins were analyzed after RFA, obtaining a high number of tumor-free margins. Compared to the control group, the reoperation rate decreased significantly (0% vs 12%; P=.02), without differences in terms of postoperative complications (10% vs 5%; P=.67) or cosmetic results (excellent or good 92.5% vs 95%; P=.3).
CONCLUSIONS


RFA after lumpectomy is a reliable, safe and successful procedure to obtain tumor-free surgical margins and to decrease the reoperation rate without affecting complications or compromising cosmetic results.",2020,"Compared to the control group, the reoperation rate decreased significantly (0% vs 12%; P=.02), without differences in terms of postoperative complications (10% vs 5%; P=.67) or cosmetic results (excellent or good 92.5% vs 95%; P=.3).
",['40 patients assigned to receive'],"['Radiofrequency ablation (RFA', 'Radiofrequency Ablation of the Surgical Bed', 'Obtaining tumor-free margins during breast conservative surgery (BCS', 'RFA', 'RFA after lumpectomy and successive resection of surgical margins, and a historical control group of 40 patients treated with BCS alone']","['postoperative complications', 'reoperation rate, complications and cosmetic results', 'cosmetic results', 'RFA effect on tumor cell viability', 'reoperation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1709157', 'cui_str': 'Tumor-Free Margins'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0229985', 'cui_str': 'Margins of Excision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}]",240.0,0.0269036,"Compared to the control group, the reoperation rate decreased significantly (0% vs 12%; P=.02), without differences in terms of postoperative complications (10% vs 5%; P=.67) or cosmetic results (excellent or good 92.5% vs 95%; P=.3).
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Jiménez Mazure', 'Affiliation': 'Unidad de Mama, Hospital Regional Universitario de Málaga, Málaga, España; Unidad de Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, España. Electronic address: carolinamazure@hotmail.com.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ribeiro González', 'Affiliation': 'Unidad de Mama, Hospital Regional Universitario de Málaga, Málaga, España; Unidad de Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Soto Aguilar', 'Affiliation': 'Unidad de Radiodiagnóstico y Radiología Intervencionista, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Hidalgo Martín', 'Affiliation': 'Unidad de Radiodiagnóstico y Radiología Intervencionista, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'Ana Josefa', 'Initials': 'AJ', 'LastName': 'Jiménez Fernández', 'Affiliation': 'Unidad de Anatomía Patológica, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'María Auxiliadora', 'Initials': 'MA', 'LastName': 'Ferrer González', 'Affiliation': 'Unidad de Mama, Hospital Regional Universitario de Málaga, Málaga, España; Unidad de Obstetricia y Ginecología, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'Ysabel', 'Initials': 'Y', 'LastName': 'Pulido Roa', 'Affiliation': 'Unidad de Mama, Hospital Regional Universitario de Málaga, Málaga, España; Unidad de Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, España.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Santoyo Santoyo', 'Affiliation': 'Unidad de Cirugía General y Digestiva, Hospital Regional Universitario de Málaga, Málaga, España.'}]",Cirugia espanola,['10.1016/j.ciresp.2020.01.010']
460,32189654,"Immunization coverage among under-five children living along a school student through child-to-child and child-to-parent information, education and communication strategy.","Background


In spite of being a principal producer and exporter of vaccines and billions spent over decades, India is home to one-third of the world's under-five children (U5C) with no immunization.
Objectives


The objective of this study was to find the outcome of child-to-child and child-to-parent Information, Education and Communication (IEC) strategy on the current percentage of immunization coverage (IC).
Methods


A mixed design research with multilevel concurrent sampling was conducted in Pune. Based on school students' households, 44 clusters having U5C were divided randomly into 11 experimental/control groups each. IEC strategy to students was independent variable and IC among U5C was dependent variable. Data were collected from 1092 students and 2352 U5C parents over 6 years. Vaccination card and Bacillus Calmette-Guérin mark were considered as evidence to conclude on full, partial and no IC. Change in knowledge quotient (KQ) among students/parents and U5C IC before and after IEC strategy assessed.
Results


Rural/urban age-appropriate full IC of U5C was 51% and 67% before and 88% and 85% in post-IEC, respectively. The mean KQ change score of 8-12/20 in students is likely to increase full IC by 37% and 18%, decrease partial coverage at 14% and 12%, and improve none coverage at 23% and 16%, from its existing level positively in experimental groups. Numerous factors discouraged parents to pursue their U5C immunization.
Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.",2019,"Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.","[""school students' households, 44 clusters having U5C"", '1092 students and 2352 U5C parents over 6 years']",[],"['knowledge quotient (KQ', 'mean KQ change score', 'partial coverage']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",,0.0295003,"Conclusions


Advocacy through school students can be an economically viable alternative marketing strategy for inadequate U5C IC than billions spent on treating vaccine-preventable diseases and impractical options.","[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Vaidyanathan', 'Affiliation': 'Professor and Principal, Pravara Institute of Medical Sciences (DU), CON, Ahmednagar, Maharashtra, India.'}]",Indian journal of public health,['10.4103/ijph.IJPH_424_18']
461,32185745,Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial.,"INTRODUCTION


The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).
METHODS


All subjects received open-label RCI (80 U) twice weekly for 12 weeks (part 1); only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) < 3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2). The primary efficacy endpoint was the proportion of subjects who achieved LDA at week 12. Secondary efficacy endpoints included proportions of subjects who maintained LDA during weeks 12 through 24 and achieved Clinical Disease Activity Index (CDAI) ≤ 10 at weeks 12 and 24. Safety was assessed via adverse event reports.
RESULTS


Of the 259 enrolled subjects, 235 completed part 1; 154 subjects (n = 77 each for RCI and placebo) entered part 2, and 127 (RCI, n = 71; placebo, n = 56) completed. At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001). At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p = 0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI ≤ 10 (p = 0.004). No unexpected safety signals were observed.
CONCLUSIONS


RCI was effective and generally safe in patients with active RA despite corticosteroid/DMARD therapy. By week 12, > 60% of patients achieved LDA, which was maintained with 12 additional weeks of treatment. Most patients who achieved LDA maintained it for 3 months after RCI discontinuation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02919761.",2020,"No unexpected safety signals were observed.
","['subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs', 'Active Rheumatoid Arthritis', 'patients with active RA despite corticosteroid/DMARD therapy', '259 enrolled subjects, 235 completed part 1; 154 subjects (n\u2009=\u200977 each for RCI and']","['repository corticotropin injection (RCI', 'placebo', 'open-label RCI', 'Repository Corticotropin Injection', 'RCI']","['proportion of subjects who achieved LDA', 'Clinical Disease Activity Index (CDAI', 'efficacy and safety', 'proportions of subjects who maintained LDA', 'LDA']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",259.0,0.441859,"No unexpected safety signals were observed.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, 8144 Walnut Hill Lane, Suite 810, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Division of Rheumatology, David Geffen School of Medicine, University of California Los Angeles, Peter Morton Medical Building, 200, UCLA Medical Plaza, Suite 365-B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Connolly-Strong', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brasington', 'Affiliation': 'Division of Rheumatology, Washington University School of Medicine, 4921 Parkview Place, Suite C, 5th Floor, St. Louis, MO, 63110, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00199-3']
462,32202624,Impact of Pictorial Cigarette Warnings Compared With Surgeon General's Warnings on Understanding of the Negative Health Consequences of Smoking.,"INTRODUCTION


The Family Smoking Prevention and Tobacco Control Act requires cigarette packages and advertisements to bear health warnings with ""color graphics depicting the negative health consequences of smoking.""
AIMS AND METHODS


This study assessed whether new US Food and Drug Administration developed pictorial cigarette warnings (PCW) increased understanding of smoking-related risks relative to the current Surgeon General's (SG) warnings. In March-May 2019, adolescent and adult smokers and nonsmokers participated in an online experiment with three sessions completed over approximately 2 weeks. Participants viewed 1 of 16 PCW (treatment conditions) or an SG warning (control) on mock cigarette packages and advertisements. Measures assessed whether warnings provided new information, induced thinking about risks, changed smoking-related health beliefs, and were accurately recalled, among other outcomes.
RESULTS


The majority of PCW (≥13 conditions) resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks; they were viewed as more informative, understandable, and attention-drawing compared with the control condition. Most participants believed the warning were factual, although 8 PCW were perceived as less factual than the control. There were changes toward more agreement with health beliefs for 11 PCW between Sessions 1 and 2 and 7 PCW between Sessions 1 and 3. Participants in all treatment conditions were more likely than control condition participants to correctly recall the warning. Across outcomes, PCW related to addiction, death, and quitting did not perform as well as other PCW.
CONCLUSIONS


Many of the PCW tested increased understanding of the risks associated with cigarette smoking relative to current SG warnings.
IMPLICATIONS


The Tobacco Control Act requires cigarette packages and advertisements to bear PCW depicting the negative health consequences of smoking. This study tested whether any of 16 newly proposed PCW increased understanding of smoking-related risks relative to existing SG warnings. Results suggest that most PCW tested, particularly those related to less widely known health effects, resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks compared with SG warnings. These results, along with other factors, informed the US Food and Drug Administration's selection of proposed PCW.",2020,"The majority of PCW (≥13 conditions) resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks; they were viewed as more informative, understandable, and attention-drawing compared with the control condition.",['Participants viewed 1 of 16 PCW (treatment conditions) or an'],"['Pictorial Cigarette Warnings', 'new US Food and Drug Administration developed pictorial cigarette warnings (PCW', 'SG warning (control) on mock cigarette packages and advertisements']","['health beliefs', 'PCW related to addiction, death, and quitting did not perform as well as other PCW', 'new information, induced thinking about risks, changed smoking-related health beliefs', 'greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks']","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0130199,"The majority of PCW (≥13 conditions) resulted in greater learning of new information, higher self-reported learning, and greater reports of thinking about smoking risks; they were viewed as more informative, understandable, and attention-drawing compared with the control condition.","[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Nguyen Zarndt', 'Affiliation': 'US Food and Drug Administration, Center for Tobacco Products, Silver Spring, MD.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Portnoy', 'Affiliation': 'US Food and Drug Administration, Center for Tobacco Products, Silver Spring, MD.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa032']
463,32193624,Use of a Discharge Educational Strategy Versus Standard Discharge Care on Reduction of Vascular Risk in Patients with Stroke and Transient Ischemic Attack.,"PURPOSE OF THE REVIEW


The burden of ischemic stroke is disproportionally distributed between ethnic and racial subgroups in the USA, minority populations with lower socioeconomic status being at higher risk. These discrepancies are mirrored in susceptibility, primary care, and post-discharge procedures. Post-discharge strategies are of particular importance as their primary goal is to prevent recurrent stroke, which makes up about 25% of stroke cases per year in US. As disadvantaged minorities have faster growing populations, recurrent stroke poses a significant challenge not only for caretakers but also for the health care system as the whole. A number of educational strategies were employed to inform the general public of major symptoms, risk factors, and preventive measures for recurrent stroke. However, over affected subgroups did not prove responsive to such measures as these did not conform to their cultural and sociological specificities.
RECENT FINDINGS


The Discharge Educational Strategies for Reduction of Vascular Events Intervention (DESERVE) is a randomized control trial with a one year follow up, set out to investigate the possibility that culturally tailored, community-centered post-discharge strategies would improve compliance to therapy and prevention against secondary stroke. The trial targeted African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group. DESERVE accomplished a significant reduction in blood pressure in the Hispanic intervention group by 9.9 mm Hg compared with usual care. The remaining two groups were not susceptible to these measures. DESERVE holds promise for culturally tailored interventions in the future in a battle against stroke and other chronic diseases.",2020,The remaining two groups were not susceptible to these measures.,"['Patients with Stroke and Transient Ischemic Attack', 'African Americans, Hispanic, and non-Hispanic whites, adapting discharge strategies for each individual group']",['Discharge Educational Strategy Versus Standard Discharge Care'],"['blood pressure', 'burden of ischemic stroke', 'Vascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0205169,The remaining two groups were not susceptible to these measures.,"[{'ForeName': 'Anantha R', 'Initials': 'AR', 'LastName': 'Vellipuram', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA. anantha-ramana.vellipuram@ttuhsc.edu.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Rawla', 'Affiliation': 'Department of Internal Medicine/Hospitalist, Sovah Health, Martinsville, VA, 24112, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Maud', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Cruz-Flores', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, Texas Tech University Health Sciences Center El Paso, Paul L. Foster School of Medicine, El Paso, TX, 79905, USA.'}]",Current cardiology reports,['10.1007/s11886-020-01283-4']
464,32185660,Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial.,"PURPOSE


Middle-aged men are at high risk of suicide. While about half of those who kill themselves visit a primary care clinician (PCC) shortly before death, in current practice, few spontaneously disclose their thoughts of suicide during the visits, and PCCs seldom inquire about such thoughts. In a randomized controlled trial, we examined the effect of a tailored interactive computer program designed to encourage middle-aged men's discussion of suicide with PCCs.
METHODS


We recruited men 35-74 years old reporting recent (within 4 weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system. In the office before a visit, men viewed the intervention corresponding to their PCC's random group assignment: Men and Providers Preventing Suicide (MAPS) (20 PCCs), providing tailored multimedia promoting discussion of suicide thoughts, or control (22 PCCs), composed of a sleep hygiene video plus brief non-tailored text encouraging discussion of suicide thoughts. Logistic regressions, adjusting for patient nesting within physicians, examined MAPS' effect on patient-reported suicide discussion in the subsequent office visit.
RESULTS


Sixteen of the randomized PCCs had no patients enroll in the trial. From the panels of the remaining 26 PCCs (12 MAPS, 14 control), 48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9 years (SD 11.4). Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]). Logistic regression showed men viewing MAPS were more likely than controls to discuss suicide with their PCC (OR 5.91, 95% CI 1.59-21.94; P = 0.008; nesting-adjusted predicted effect 71% vs. 30%).
CONCLUSIONS


In addressing barriers to discussing suicide, the tailored MAPS program activated middle-aged men with active suicide thoughts to engage with PCCs around this customarily taboo topic.",2020,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"['Middle-Aged Men', 'Men and Providers Preventing Suicide (MAPS) (20 PCCs', ""middle-aged men's discussion of suicide with PCCs"", '48 men (MAPS 21, control 27) were enrolled (a mean of 1.8 (range 1-5) per PCC), with a mean age of 55.9\xa0years (SD 11.4', 'Middle-aged men', 'Sixteen of the randomized PCCs', 'We recruited men 35-74\xa0years old reporting recent (within 4\xa0weeks) active suicide thoughts from the panels of 42 PCCs (the unit of randomization) in eight offices within a single California health system']",['tailored interactive computer program'],['Suicide discussion'],"[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]",,0.0509858,Suicide discussion was more likely among MAPS patients (15/21 [65%]) than controls (8/27 [35%]).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Jerant', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA. afjerant@ucdavis.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, 683 Hoes Lane West, Piscataway, NJ, 08854, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, UCD School of Medicine, 4150 V Street, Suite 2400, PSSB, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Cipri', 'Affiliation': 'Center for Healthcare Policy and Research, UCD, 2103 Stockton Blvd, Sacramento, CA, 95817, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Franks', 'Affiliation': 'Department of Family and Community Medicine, University of California Davis (UCD) School of Medicine, 4860 Y Street, Suite 2300, Sacramento, CA, 95817, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05769-3']
465,32064596,"The efficacy and safety of topical rapamycin-calcitriol for facial angiofibromas in patients with tuberous sclerosis complex: a prospective, double-blind, randomized clinical trial.","BACKGROUND


The efficacy of topical rapamycin is well documented for tuberous sclerosis complex (TSC)-related facial angiofibromas (FAs). Calcitriol has been shown to lessen skin fibrosis and may be therapeutically beneficial to FAs.
OBJECTIVES


To evaluate whether topical rapamycin-calcitriol combination is an effective and safe treatment for TSC-related FAs.
METHODS


Fifty-two patients with TSC with FAs were enrolled in this prospective study including three 12-week periods. In period 1, either topical rapamycin 0·1% or calcitriol 0·0003% single-agent therapy vs. their combination was applied in a double-blind, left-right-randomized, split-face comparison. The primary outcome was the reduction of modified Facial Angiofibroma Severity Index (mFASI) at week 12. In period 2, the patients were reassigned to use on both cheeks the ointment that resulted in the better primary outcome in period 1. The treatment was discontinued in period 3 (week 25-36) and a follow-up mFASI was scored to evaluate the degree of recurrence.
RESULTS


The mean changes in mFASI at week 12 compared with baseline were -0·92, -0·44 and -1·09 for rapamycin (P ≤ 0·001), calcitriol (P = 0·039) and rapamycin-calcitriol combination (P ≤ 0·001), respectively. Although rapamycin-calcitriol combination and rapamycin had similar statistically significant decreases of mFASI at week 12, rapamycin-calcitriol combination resulted in faster improvement in erythema, greater reduction of papule elevation and longer durability after discontinuing treatment than rapamycin alone. The treatments were well tolerated.
CONCLUSIONS


This randomized clinical trial demonstrates that topical rapamycin-calcitriol combination therapy is an effective and safe regimen for TSC-related FAs. What is already known about this topic? Facial angiofibromas (FAs) cause substantial psychological distress in individuals with tuberous sclerosis complex (TSC), but invasive procedural treatments are not applicable to all patients. Topical rapamycin has been demonstrated as an effective and safe treatment regimen for TSC-related FAs. What does this study add? Compared with baseline (day 0), both topical rapamycin 0·1% and rapamycin 0·1%-calcitriol 0·0003% combination ointment achieved statistically significant reductions in modified Facial Angiofibroma Severity Index at week 12. Compared with rapamycin alone, extended use of the rapamycin-calcitriol combination regimen until week 24 showed more effectiveness in decreasing papule elevation and could maintain a longer therapeutic effect after treatment discontinuation. Linked Comment: Lee. Br J Dermatol 2020; 183:604-606.",2020,"The mean reduction of mFASI at week 12 comparing to baseline was -0.92, -0.44, and -1.09 for rapamycin (P < .001), calcitriol (P = .039), and rapamycin-calcitriol combination (P < .001), respectively.","['patients with tuberous sclerosis complex', 'Fifty-two TSC patients with FAs']","['Calcitriol', 'topical rapamycin-calcitriol combination', 'topical rapamycin', 'rapamycin', 'rapamycin-calcitriol combination and rapamycin', 'topical rapamycin-calcitriol combination therapy', 'topical rapamycin/calcitriol', 'calcitriol']","['tolerated', 'papule elevation and longer durability', 'mFASI', 'reduction of modified Facial Angiofibroma Severity Index (mFASI', 'mean reduction of mFASI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041341', 'cui_str': 'Sclerosis Tuberosa'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0265319', 'cui_str': 'Adenoma Sebaceum'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",52.0,0.122836,"The mean reduction of mFASI at week 12 comparing to baseline was -0.92, -0.44, and -1.09 for rapamycin (P < .001), calcitriol (P = .039), and rapamycin-calcitriol combination (P < .001), respectively.","[{'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medical Genomics and Proteomics, Taipei, Taiwan.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Shen', 'Affiliation': 'Graduate Institute of Clinical Pharmacy/School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medical Genomics and Proteomics, Taipei, Taiwan.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Medical Genomics and Proteomics, Taipei, Taiwan.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Liao', 'Affiliation': 'Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}]",The British journal of dermatology,['10.1111/bjd.18949']
466,31709984,1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA).,"OBJECTIVES


The aim of this study was to test the hypothesis that invasive coronary function testing at time of angiography could help stratify management of angina patients without obstructive coronary artery disease.
BACKGROUND


Medical therapy for angina guided by invasive coronary vascular function testing holds promise, but the longer-term effects on quality of life and clinical events are unknown among patients without obstructive disease.
METHODS


A total of 151 patients with angina with symptoms and/or signs of ischemia and no obstructive coronary artery disease were randomized to stratified medical therapy guided by an interventional diagnostic procedure versus standard care (control group with blinded interventional diagnostic procedure results). The interventional diagnostic procedure-facilitated diagnosis (microvascular angina, vasospastic angina, both, or neither) was linked to guideline-based management. Pre-specified endpoints included 1-year patient-reported outcome measures (Seattle Angina Questionnaire, quality of life [EQ-5D]) and major adverse cardiac events (all-cause mortality, myocardial infarction, unstable angina hospitalization or revascularization, heart failure hospitalization, and cerebrovascular event) at subsequent follow-up.
RESULTS


Between November 2016 and December 2017, 151 patients with ischemia and no obstructive coronary artery disease were randomized (n = 75 to the intervention group, n = 76 to the control group). At 1 year, overall angina (Seattle Angina Questionnaire summary score) improved in the intervention group by 27% (difference 13.6 units; 95% confidence interval: 7.3 to 19.9; p < 0.001). Quality of life (EQ-5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 95% confidence interval: 0.03 to 0.19; p = 0.010). After a median follow-up duration of 19 months (interquartile range: 16 to 22 months), major adverse cardiac events were similar between the groups, occurring in 9 subjects (12%) in the intervention group and 8 (11%) in the control group (p = 0.803).
CONCLUSIONS


Stratified medical therapy in patients with ischemia and no obstructive coronary artery disease leads to marked and sustained angina improvement and better quality of life at 1 year following invasive coronary angiography. (Coronary Microvascular Angina [CorMicA]; NCT03193294).",2020,Quality of life (EQ5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 0.03 to 0.19;p=0.010).,"['patients without obstructive disease', '151 angina patients with symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA', 'Between 11/2016-12/2017 151 INOCA patients were randomized (n=75 intervention group; n=76 control group']","['Angina Management Guided by Invasive Coronary Function Testing (CorMicA', 'stratified medical therapy guided by an interventional diagnostic procedure (IDP) versus standard care (control group with blinded IDP results']","['1-year patient reported outcome measures (Seattle Angina Questionnaire [SAQ], quality of life [EQ5D]) and major adverse cardiovascular events (all- cause mortality, myocardial infarction, unstable angina hospitalization/revascularization, heart failure hospitalization, cerebrovascular event) at subsequent follow-up', 'Quality of life (EQ5D index', 'overall angina (SAQ summary score', 'sustained angina improvement and better quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021532', 'cui_str': 'Riboxin'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",151.0,0.0885377,Quality of life (EQ5D index) improved in the intervention group relative to the control group (mean difference 0.11 units [18%]; 0.03 to 0.19;p=0.010).,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; Gosford Hospital, NSW Health, Gosford, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Novalia', 'Initials': 'N', 'LastName': 'Sidik', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hood', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'McGeoch', 'Affiliation': 'University Hospital Hairmyres, East Kilbride, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McDade', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yii', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rush', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Rhian M', 'Initials': 'RM', 'LastName': 'Touyz', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.11.001']
467,32065827,Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial.,"Importance


Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.
Objective


To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.
Design, Setting, and Participants


Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.
Interventions


Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.
Main Outcomes and Measures


The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
Results


Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
Conclusions and Relevance


In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT03376347.",2020,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","['adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019', 'During Elective Noncardiac Surgery', '68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women', 'patients undergoing elective noncardiac surgery']","['early warning system (n\u2009=\u200934) or standard care', 'Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care', 'machine learning-derived early warning system compared with standard care']","['median time of hypotension', 'mean arterial pressure (MAP', 'intraoperative hypotension', 'time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury', 'median length of surgery', 'Hypotension', 'median time-weighted average of hypotension', '0 serious adverse events resulting in death', 'morbidity and mortality', 'Depth and Duration of Intraoperative Hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517362', 'cui_str': 'Hypotension during surgery (disorder)'}, {'cui': 'C1519795', 'cui_str': 'Unit of measure (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",68.0,0.308548,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Lemmers', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marijn P', 'Initials': 'MP', 'LastName': 'Mulder', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte E', 'Initials': 'LE', 'LastName': 'Terwindt', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2020.0592']
468,31788775,Comparison of Hemodynamic Stability and Pain Control in Lateral and Prone Positions in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Trial.,"PURPOSE


Percutaneous nephrolithotomy (PCNL) is the preferred surgical treatment in many cases of kidney stones which is performed in different positions such as prone, lateral, and supine. This study was designed to evaluate whether patient position (lateral versus . prone) has an effect on the need for analgesia and onset of pain after surgery.
MATERIALS AND METHODS


Patient with confirmed kidney stones (size ? 2 cm) who were candidates for PCNL were enrolled in this study. The required biochemical analyses were performed preoperatively. All patients  underwent spinal anesthesia by the same anesthesiologists and then were randomly divided into two separate groups as lateral (L) and prone (P) positions. The operations' start and end time, required time for proper access into target calyces, additional need for analgesic or cardiac drugs, duration of analgesia, and onset of pain after PCNL were carefully recorded and then compared between the two groups.
RESULTS


In total, 51 patients were evaluated of whom 39 were men and 12 were women. Mean duration of analgesia after PCNL surgery in P group (173 ± 8 min) was significantly longer than in L group (147±12 min) (P = .001). Furthermore, the amount of ephedrine usage in L group (3.6 ± 1.5mg) was significantly lower than in the P group (16.4 ± 12mg), suggesting more hemodynamic variations in the P group during the operation.
CONCLUSION


Our randomized control trial study shows that choosing the optimal position in the PCNL technique depends on  patient's condition. If hemodynamic control is of matter to the anesthesiologist, then lateral position is more appropriate. However, if control of pain and longer time of analgesia are important,  prone position may be preferred.",2020,Duration of analgesia after PCNL surgery in P group (173±8 min) was significantly longer than in L group (147±12 min) (P=.001).,"['Patient with confirmed kidney stones (size ', '51 patients were evaluated of whom 39 were men and 12 were women', 'Patients undergoing Percutaneous Nephrolithotomy', '2 cm) who were candidate for PCNL']","['Hemodynamic Stability and Pain Control', 'Percutaneous Nephrolithotomy (PCNL']","['hemodynamic variations', ""operations' start and end time, required time for proper access into target calyces, additional need for analgesic or cardiac drugs, duration of analgesia, and onset of pain after PCNL"", 'Duration of analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0022651', 'cui_str': 'Kidney Calices'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",51.0,0.0301034,Duration of analgesia after PCNL surgery in P group (173±8 min) was significantly longer than in L group (147±12 min) (P=.001).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Roodneshin', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr_roodneshin_f2007@yahoo.com.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Poor Zamany Nejat Kermany', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Ahmadzadeh', 'Affiliation': 'Mofid Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Gharaei', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Kamranmanesh', 'Affiliation': 'Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4915']
469,31492797,Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK: protocol of the UKGRIS cluster-randomised registry-based trial.,"INTRODUCTION


For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.
METHODS AND ANALYSIS


The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.
ETHICS AND DISSEMINATION


The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder's open access policy.
TRIAL REGISTRATION NUMBER


ISRCTN29731761; Pre-results.",2019,"Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.
","['3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records', 'patients hospitalised with non-ST elevation acute coronary syndrome in the UK']",[],"['use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission', 'duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up']","[{'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]",[],"[{'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",3000.0,0.15335,"Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.
","[{'ForeName': 'Colin C', 'Initials': 'CC', 'LastName': 'Everett', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Keith Aa', 'Initials': 'KA', 'LastName': 'Fox', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharples', 'Affiliation': 'Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Carruthers', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hemingway', 'Affiliation': 'Health Data Research UK London, UCL, London, UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': ""St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brieger', 'Affiliation': 'The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Chew', 'Affiliation': 'Department of Cardiovascular Medicine, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Chris P', 'Initials': 'CP', 'LastName': 'Gale', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032165']
470,31494615,The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study.,"INTRODUCTION


The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.
METHODS/ANALYSIS


This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.
ETHICS/DISSEMINATION


The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.
TRIAL REGISTRATION NUMBER


ACTRN12614001226695.",2019,"The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.
","['8880 patients undergoing elective major surgery will be enrolled', '45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands']","['dexamethasone', 'dexamethasone 8\u2009mg or placebo']","['surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",,0.549863,"The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.
","[{'ForeName': 'Tomás B', 'Initials': 'TB', 'LastName': 'Corcoran', 'Affiliation': 'Royal Perth Hospital, Perth, Western Australia, Australia mascor@bigpond.net.au.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': ""O'Loughlin"", 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Short', 'Affiliation': 'Auckland City Hospital, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Matthew Tv', 'Initials': 'MT', 'LastName': 'Chan', 'Affiliation': 'Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Coutts', 'Affiliation': 'Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Jaspreet', 'Initials': 'J', 'LastName': 'Sidhu', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Leon A', 'Initials': 'LA', 'LastName': 'Bach', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': 'Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-030402']
471,31494621,"Prospective multicentre cohort trial on acute appendicitis and microbiota, aetiology and effects of antimicrobial treatment: study protocol for the MAPPAC (Microbiology APPendicitis ACuta) trial.","INTRODUCTION


Based on the epidemiological and clinical data, acute appendicitis can present either as uncomplicated or complicated. The aetiology of these different appendicitis forms remains unknown. Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis. Despite appendicitis being one of the most common surgical emergencies, there are very few reports on appendicitis aetiology and pathophysiology focusing on the differences between uncomplicated and complicated appendicitis. Microbiology APPendicitis ACuta (MAPPAC) trial aims to evaluate these microbiological and immunological aspects including immune response in the aetiology of these different forms also assessing both antibiotics non-responders and appendicitis recurrence. In addition, MAPPAC aims to determine antibiotic and placebo effects on gut microbiota composition and antimicrobial resistance.
METHODS AND ANALYSIS


MAPPAC is a prospective clinical trial with both single-centre and multicentre arm conducted in close synergy with concurrent trials APPendicitis ACuta II (APPAC II) (per oral (p.o.) vs intravenous+p.o. antibiotics, NCT03236961) and APPAC III (double-blind trial placebo vs antibiotics, NCT03234296) randomised clinical trials. Based on the enrolment for these trials, patients with CT-confirmed uncomplicated acute appendicitis are recruited also to the MAPPAC study. In addition to these conservatively treated randomised patients with uncomplicated acute appendicitis, MAPPAC will recruit patients with uncomplicated and complicated appendicitis undergoing appendectomy. Rectal and appendiceal swabs, appendicolith, faecal and serum samples, appendiceal biopsies and clinical data are collected during the hospital stay for microbiological and immunological analyses in both study arms with the longitudinal study arm collecting faecal samples also during follow-up up to 12 months after appendicitis treatment.
ETHICS AND DISSEMINATION


This study has been approved by the Ethics Committee of the Hospital District of Southwest Finland (Turku University Hospital, approval number ATMK:142/1800/2016) and the Finnish Medicines Agency. Results of the trial will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03257423.",2019,"Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis.","['Hospital District of Southwest Finland', 'patients with CT-confirmed uncomplicated acute appendicitis', 'patients with uncomplicated and complicated appendicitis undergoing appendectomy']","['APPendicitis ACuta II (APPAC II) (per oral (p.o.) vs intravenous+p.o', 'MAPPAC', 'Antibiotic therapy']",['gut microbiota composition and antimicrobial resistance'],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]","[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]",,0.169556,"Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis.","[{'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Vanhatalo', 'Affiliation': 'Institute of Biomedicine, Research Center for Cancer, Infections and Immunity, University of Turku, Turku, Finland.'}, {'ForeName': 'Eveliina', 'Initials': 'E', 'LastName': 'Munukka', 'Affiliation': 'Microbiome Biobank, Faculty of Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sippola', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Jalkanen', 'Affiliation': 'Medicity and Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Marttila', 'Affiliation': 'Department of Hospital Hygiene and Infection Control, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Eerola', 'Affiliation': 'Institute of Biomedicine, Research Center for Cancer, Infections and Immunity, University of Turku, Turku, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Antti J', 'Initials': 'AJ', 'LastName': 'Hakanen', 'Affiliation': 'Institute of Biomedicine, Research Center for Cancer, Infections and Immunity, University of Turku, Turku, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland paulina.salminen@tyks.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-031137']
472,30322793,A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy.,"PURPOSE


Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed.
METHODS


In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study.
RESULTS


Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01).
CONCLUSIONS


Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.",2019,"Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both).",['Women Undergoing Stereotactic Breast Biopsy'],"['Brief Mindfulness Meditation', 'guided mindfulness-based meditation (GM; n\xa0= 30), focused breathing (FB; n\xa0= 30), or standard care', 'Stereotactic breast biopsy (SBB']","['Anxiety and pain', 'delta activity', 'pain ratings', 'Electroencephalographic activity', 'steeper reduction in anxiety', 'beta activity', 'anterior cingulate cortex', 'anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast (procedure)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}]",,0.0607836,"Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both).","[{'ForeName': 'Chelsea G', 'Initials': 'CG', 'LastName': 'Ratcliff', 'Affiliation': 'Sam Houston State University, Huntsville, Texas; Baylor College of Medicine, Houston, Texas. Electronic address: chelsea.ratcliff@shsu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prinsloo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chaoul', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Stephanie G', 'Initials': 'SG', 'LastName': 'Zepeda', 'Affiliation': 'Our Lady of the Lake University, The Woodlands, Texas.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Cannon', 'Affiliation': 'Knoxville Neurofeedback Group, Knoxville, Tennessee.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Spelman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Wei T', 'Initials': 'WT', 'LastName': 'Yang', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Journal of the American College of Radiology : JACR,['10.1016/j.jacr.2018.09.009']
473,31953832,Comparison of Removing Double-J Stent With and Without Cystoscopy in Kidney Transplant Patients: A Randomized Clinical Trial.,"PURPOSE


The ureteric stent can be attached to the Foley catheter in kidney transplantation to exclude cystoscopy for its removal. It is rarely practiced in renal transplantation. There has been no randomized trial to evaluate the outcome of this procedure on major urologic complications.
MATERIALS AND METHODS


One hundred sixty-three kidney transplant patients were randomized into an intervention group in which the stent was attached to the Foley catheter and removed together and a control group in which stent was removed by cystoscopy. In both groups, stents were removed around the 8th post-operative day.
RESULTS


From March 2016 to June 2017, out of 234 kidney transplants performed in our center, one hundred Sixty-three (69.6%) patients met the study inclusion criteria.  91patients (55.8%) were allocated to the intervention group. Mean days before JJ removal for intervention and control groups (""per-protocol"" group) were 8.08 ± 1.52 and 8.57 ± 1.58, respectively (P = .09). There was no difference between groups regarding major urologic complications (P = .679). Visual analog scale pain scores were significantly higher in the control group (p = .001). The procedure reduced 63-120 USD from the cost of operation in the intervention group.
CONCLUSION


In selected kidney transplant patients, attaching stent to the Foley catheter and removing both of them early may be a safe maneuver regarding major urological complications, reduces pain, and eliminates the cost of cystoscopy.",2020,Visual analog scale pain scores were significantly higher in the control group (p=.001).,"['One hundred sixty-three kidney transplant patients', 'Kidney Transplant Patients', 'From March 2016 to June 2017, out of 234 kidney transplants performed in our center, a hundred Sixty-three (69.6%) patients met the study inclusion criteria']","['stent attached to the Foley catheter and removed together and a control group in which stent removed by cystoscopy', 'Removing Double-J Stent With and Without Cystoscopy']","['Visual analog scale pain scores', 'Mean days before JJ removal', 'major urologic complications']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0179804'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent (physical object)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",163.0,0.0731579,Visual analog scale pain scores were significantly higher in the control group (p=.001).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nadjafi-Semnani', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran. monadjafi@gmail.com.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Simforoosh', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tabibi', 'Affiliation': 'Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Urology and Nephrology Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nadjafi-Semnani', 'Affiliation': 'Resident in General Surgery, Shiraz, Iran.'}]",Urology journal,['10.22037/uj.v0i0.5448']
474,31114976,"Re: Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate. A Prospective, Double Blind Randomized Study.",none.,2020,,[],['Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate'],[],[],"[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]",[],,0.281278,,"[{'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Doo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea. ruiwin3518@gmail.com.'}, {'ForeName': 'Yu Seob', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Myung Kim', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",Urology journal,['10.22037/uj.v0i0.5242']
475,31492784,The influence of antiresorptive bone medication on the effect of high-intensity resistance and impact training on osteoporotic fracture risk in postmenopausal women with low bone mass: protocol for the MEDEX-OP randomised controlled trial.,"INTRODUCTION


Antiresorptive medications increase bone density and decrease vertebral fracture, while high-intensity resistance and impact training (HiRIT) increases balance, bone and muscle strength decreasing risk for falls and fractures. Medications are typically prescribed by doctors and exercise by exercise specialists, frequently in isolation.
OBJECTIVE


Our primary aim is to determine the effect of an 8-month HiRIT programme with or without osteoporosis medications on bone mineral density (BMD) of the spine and hip in postmenopausal women with low bone mass.
METHODS AND ANALYSIS


One hundred and sixty postmenopausal women with low bone mass will be recruited from the community to participate in an 8-month randomised controlled trial. Participants will be on stable doses of antiresorptive bone medication for at least 12 months (n=80) or have not taken bone medications for at least 12 months (n=80). Participants will be block randomised, stratified by medication intake, to twice-weekly 40-min supervised sessions of HiRIT or a low-intensity exercise programme (control). Primary outcomes include change in lumbar spine and total hip areal bone mineral density. Secondary outcomes include whole body, femoral neck and forearm BMD, proximal femur bone geometry and volumetric density, vertebral morphology, body composition, anthropometry, physical function, posture, rate of falls, osteoarthritis symptoms, pelvic floor health, quality of life, physical activity enjoyment, resting blood pressure, safety and compliance. All outcomes will be assessed at baseline and 8 months and intention-to-treat and per-protocol analyses will be conducted. Repeated measure analysis of covariance will be used to determine intervention effects on outcome measures, controlling for initial values, compliance and other variables found to differ between groups at baseline.
ETHICS AND DISSEMINATION


The study has been approved by Griffith University Human Research Ethics Committee (Ref: 2017/739). Results will be reported in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12617001511325).",2019,"Participants will be block randomised, stratified by medication intake, to twice-weekly 40-min supervised sessions of HiRIT or a low-intensity exercise programme (control).","['One hundred and sixty postmenopausal women with low bone mass', 'postmenopausal women with low bone mass', 'Participants will be on stable doses of antiresorptive bone medication for at least 12 months (n=80) or have not taken bone medications for at least 12 months (n=80']","['antiresorptive bone medication', 'impact training', 'HiRIT programme with or without osteoporosis medications', 'HiRIT or a low-intensity exercise programme (control']","['bone density and decrease vertebral fracture', 'osteoporotic fracture risk', 'bone mineral density (BMD', 'whole body, femoral neck and forearm BMD, proximal femur bone geometry and volumetric density, vertebral morphology, body composition, anthropometry, physical function, posture, rate of falls, osteoarthritis symptoms, pelvic floor health, quality of life, physical activity enjoyment, resting blood pressure, safety and compliance', 'change in lumbar spine and total hip areal bone mineral density']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",160.0,0.168164,"Participants will be block randomised, stratified by medication intake, to twice-weekly 40-min supervised sessions of HiRIT or a low-intensity exercise programme (control).","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Fischbacher', 'Affiliation': 'Menzies Health Institute Queensland and School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland and School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland and School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia b.beck@griffith.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-029895']
476,31492788,Cluster randomised controlled trial of an online intervention to improve healthy food purchases from primary school canteens: a study protocol of the 'click & crunch' trial.,"INTRODUCTION


School canteens are the most frequently accessed take-away food outlet by Australian children. The rapid development of online lunch ordering systems for school canteens presents new opportunities to deliver novel public health nutrition interventions to school-aged children. This study aims to assess the effectiveness and cost-effectiveness of a behavioural intervention in reducing the energy, saturated fat, sugar and sodium content of online canteen lunch orders for primary school children.
METHODS AND ANALYSIS


The study will employ a cluster randomised controlled trial design. Twenty-six primary schools in New South Wales, Australia, that have an existing online canteen ordering system will be randomised to receive either a multi-strategy behavioural intervention or a control (the standard online canteen ordering system). The intervention will be integrated into the existing online canteen system and will seek to encourage the purchase of healthier food and drinks for school lunch orders (ie, items lower in energy, saturated fat, sugar and sodium). The behavioural intervention will use evidence-based choice architecture strategies to redesign the online menu and ordering system including: menu labelling, placement, prompting and provision of feedback and incentives. The primary trial outcomes will be the mean energy (kilojoules), saturated fat (grams), sugar (grams) and sodium (milligrams) content of lunch orders placed via the online system, and will be assessed 12 months after baseline data collection.
ETHICS AND DISSEMINATION


The study was approved by the ethics committees of the University of Newcastle (H-2017-0402) and the New South Wales Department of Education and Communities (SERAP 2018065), and the Catholic Education Office Dioceses of Sydney, Parramatta, Lismore, Maitland-Newcastle, Bathurst, Canberra-Goulburn, Wollongong, Wagga Wagga and Wilcannia-Forbes. Study results will be disseminated through peer-reviewed publications, reports, presentations at relevant national and international conferences and via briefings to key stakeholders. Results will be used to inform future implementation of public health nutrition interventions through school canteens, and may be transferable to other food settings or online systems for ordering food.
TRIAL REGISTRATION NUMBER


ACTRN12618000855224.",2019,"The intervention will be integrated into the existing online canteen system and will seek to encourage the purchase of healthier food and drinks for school lunch orders (ie, items lower in energy, saturated fat, sugar and sodium).","['primary school children', 'school-aged children', 'healthy food purchases from primary school canteens', 'Twenty-six primary schools in New South Wales, Australia, that have an existing online canteen ordering system', 'ethics committees of the University of Newcastle (H-2017-0402) and the New South Wales Department of Education and Communities (SERAP 2018065), and the Catholic Education Office Dioceses of Sydney, Parramatta, Lismore, Maitland-Newcastle, Bathurst, Canberra-Goulburn, Wollongong, Wagga Wagga and Wilcannia-Forbes']","['behavioural intervention', 'online intervention']","['effectiveness and cost-effectiveness', 'mean energy (kilojoules), saturated fat (grams), sugar (grams) and']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]",26.0,0.137897,"The intervention will be integrated into the existing online canteen system and will seek to encourage the purchase of healthier food and drinks for school lunch orders (ie, items lower in energy, saturated fat, sugar and sodium).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia r.wyse@newcastle.edu.au.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Delaney', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Pennie', 'Initials': 'P', 'LastName': 'Gibbins', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'School of Exercise & Nutrition Science, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'School of Exercise & Nutrition Science, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Seward', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zoetemeyer', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'New South Wales Office of Preventive Health, Liverpool, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-030538']
477,31492796,Comparison of the outcomes of warfarin therapy and economics by online and offline anticoagulation management models: protocol for a randomised controlled trial.,"INTRODUCTION


Warfarin is widely used in the world as oral anticoagulant, but it is difficult to manage patients after medication due to its narrow treatment window and individualised differences. Therefore, every region uses network means to carry out online anticoagulant therapy services. The purpose of this paper is to compare monitoring results and randomised controlled studies of the complications of warfarin treated by offline or online management in a Chinese population.
METHODS AND ANALYSIS


This is a randomised controlled, multicentre clinical trial. Taking the Union Hospital Affiliated to Fujian Medical University as the main centre, a randomised controlled study of several subcentres around China produced a nationally representative sample. 496 participants who took warfarin will be recruited and then randomly divided into two groups at a ratio of 1:1. We will collect data on patient characteristics, diagnosis, treatment, hospitalisation results and later complications.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of the Union Hospital Affiliated to Fujian Medical University. All cooperative hospitals have been approved by the Central Ethics Committee. The results of the survey will be disseminated in future peer review documents and will provide the basis for a management model for patients in China taking warfarin.
TRIAL REGISTRATION NUMBER


ChiCTR1900021920.",2019,"The results of the survey will be disseminated in future peer review documents and will provide the basis for a management model for patients in China taking warfarin.
","['Taking the Union Hospital Affiliated to Fujian Medical University as the main centre', '496 participants who took', 'patients in China taking warfarin', 'Union Hospital Affiliated to Fujian Medical University', 'a Chinese population']","['warfarin therapy', 'Warfarin', 'warfarin treated by offline or online management', 'warfarin']",[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]",[],496.0,0.118257,"The results of the survey will be disseminated in future peer review documents and will provide the basis for a management model for patients in China taking warfarin.
","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'College of Pharmacy, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jinglan', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'College of Pharmacy, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'College of Pharmacy, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'College of Pharmacy, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Jinhua', 'Affiliation': 'College of Pharmacy, Fujian Medical University, Fuzhou, China pollyzhang2006@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-031730']
478,31750703,Pain characteristics and nicotine deprivation as predictors of performance during a laboratory paradigm of smoking cessation.,"Although smokers with co-occurring pain report expectations for experiencing greater nicotine withdrawal and difficulty quitting, limited work has examined the role of pain in cessation-related outcomes. The goal of this study was to examine clinically relevant pain characteristics (pain persistence, pain intensity, pain-related disability) as predictors of withdrawal and smoking lapse/relapse outcomes using a laboratory paradigm of cessation. Participants ( N  = 120 daily cigarette smokers; 48% male;  M age  = 36.17, SD = 12.16;  M Cigarettes Per Day  = 20.51, SD = 6.99) were randomized to either nondeprived or 12-hr nicotine deprivation conditions prior to an experimental study visit. Upon arrival to the laboratory, participants completed measures of pain characteristics and nicotine withdrawal symptoms. Primary outcomes included nicotine withdrawal scores and analogues of smoking lapse (latency to initiating smoking) and relapse (number of cigarettes smoked). We hypothesized that smokers with greater pain persistence, pain intensity, and pain-related disability would endorse more severe nicotine withdrawal and greater lapse/relapse behavior, and that these positive associations would be stronger among those who were nicotine deprived. Results indicated that, above and beyond the effect of nicotine deprivation, persistent pain predicted more severe nicotine withdrawal, and that greater pain-related disability predicted quicker latency to lapse during the laboratory paradigm. Contrary to expectation, nicotine deprivation did not moderate effects of pain characteristics on withdrawal or lapse/relapse outcomes. Clinical implications include that different pain processes may influence different cessation outcomes, and that smokers in pain may benefit from the provision of pharmacological aids to better control withdrawal symptoms. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Contrary to expectation, nicotine deprivation did not moderate effects of pain characteristics on withdrawal or lapse/relapse outcomes.","['Participants ( N  = 120 daily cigarette smokers; 48% male;  M age  = 36.17, SD = 12.16;  M Cigarettes Per Day  = 20.51, SD ']",['nondeprived or 12-hr nicotine deprivation conditions'],"['nicotine withdrawal scores and analogues of smoking lapse (latency to initiating smoking) and relapse (number of cigarettes smoked', 'pain persistence, pain intensity, and pain-related disability', 'pain characteristics and nicotine withdrawal symptoms', 'relevant pain characteristics (pain persistence, pain intensity, pain-related disability']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2019.0,0.0702458,"Contrary to expectation, nicotine deprivation did not moderate effects of pain characteristics on withdrawal or lapse/relapse outcomes.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'LaRowe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Bryan W', 'Initials': 'BW', 'LastName': 'Heckman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Ditre', 'Affiliation': 'Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000532']
479,31750899,Ticagrelor monotherapy versus aspirin in patients undergoing multiple arterial or single arterial coronary artery bypass grafting: insights from the TiCAB trial.,"OBJECTIVES


We evaluated the effect of ticagrelor monotherapy on outcomes after multiple arterial grafting (MAG) or single arterial grafting (SAG) in coronary artery bypass grafting (CABG).
METHODS


In a post hoc, non-randomized analysis of the TiCAB (Ticagrelor in CABG; ClinicalTrials.gov NCT01755520) trial, we compared event rates for ticagrelor versus aspirin in patients undergoing MAG and SAG. Primary outcome was the composite of cardiovascular death, non-fatal myocardial infarction (MI), stroke or repeat revascularization 1 year after CABG. Secondary outcomes included individual components of the primary end point, all-cause death and bleeding.
RESULTS


Among 1753 patients, 998 patients underwent MAG and 755 patients underwent SAG. There was no significant difference in the 1-year primary composite outcome for ticagrelor versus aspirin with MAG [7.2% vs 7.9%; hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.57-1.43; P = 0.66] or SAG (12.3% vs 8.6%; HR 1.47, 95% CI 0.93-2.31; P = 0.10). Event rates for cardiovascular death, MI, stroke, repeat revascularization and all-cause death were similar for both treatment groups with MAG and SAG. No significant difference in major bleeding was observed for ticagrelor versus aspirin with MAG (2.6% vs 2.7%; HR 0.95, 95% CI 0.44-2.05; P = 0.90) or SAG (5.8% vs 4.0%; HR 1.49, 95% CI 0.77-2.89; P = 0.24).
CONCLUSIONS


In patients undergoing either MAG or SAG in the TiCAB trial, ticagrelor monotherapy compared with aspirin did not affect the rate of cardiovascular death, non-fatal MI, stroke or repeat revascularization, or the rate of bleeding, at 1 year after CABG.",2020,"Event rates for cardiovascular death, MI, stroke, repeat revascularization and all-cause death were similar for both treatment groups with MAG and SAG.","['1753 patients, 998 patients underwent MAG and 755 patients underwent', 'patients undergoing multiple arterial or single arterial coronary artery bypass grafting', 'coronary artery bypass grafting (CABG', 'patients undergoing MAG and SAG']","['SAG', 'MAG or SAG', 'Ticagrelor monotherapy versus aspirin', 'ticagrelor versus aspirin', 'multiple arterial grafting (MAG) or single arterial grafting (SAG', 'aspirin', 'TiCAB (Ticagrelor', 'ticagrelor', 'ticagrelor monotherapy']","['cardiovascular death, MI, stroke, repeat revascularization and all-cause death', 'major bleeding', 'individual components of the primary end point, all-cause death and bleeding', 'rate of cardiovascular death, non-fatal MI, stroke or repeat revascularization, or the rate of bleeding', 'composite of cardiovascular death, non-fatal myocardial infarction (MI), stroke or repeat revascularization 1\u2009year after CABG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0129439', 'cui_str': 'Sialic Acid Binding Ig-Like Lectin 4A'}, {'cui': 'C4517872', 'cui_str': 'Seven hundred and fifty-five'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0129439', 'cui_str': 'Sialic Acid Binding Ig-Like Lectin 4A'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]",1753.0,0.282416,"Event rates for cardiovascular death, MI, stroke, repeat revascularization and all-cause death were similar for both treatment groups with MAG and SAG.","[{'ForeName': 'Sigrid E', 'Initials': 'SE', 'LastName': 'Sandner', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wiedemann', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misfeld', 'Affiliation': 'Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Böning', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Tebbe', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, Hospital Lippe-Detmold, Detmold, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Nowak', 'Affiliation': 'Cardiovascular Center Bethanien, Frankfurt, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stritzke', 'Affiliation': 'Marienstein Privatklinik, List, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Laufer', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'von Scheidt', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz313']
480,30882730,Impact of Trimethoprim-sulfamethoxazole Urinary Tract Infection Prophylaxis on Non-UTI Infections.,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.",2019,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.",['Children with Vesicoureteral Reflux cohort'],"['Trimethoprim-sulfamethoxazole', 'trimethoprim-sulfamethoxazole']","['risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042580', 'cui_str': 'Vesicoureteral Reflux'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0149778', 'cui_str': 'Soft Tissue Infection'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0460613,"In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated with an increased or decreased risk of skin and soft tissue infections, pharyngitis or sinopulmonary infections in otherwise healthy children 2-71 months of age.","[{'ForeName': 'Sanyukta', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ""From the Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati OH.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases in the Departments of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002167']
481,31004340,Extracorporeal Shockwave Therapy Combined with Drug Therapy in Chronic Pelvic Pain Syndrome : A Randomized Clinical Trial.,"PURPOSE


Chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS) is a nonspecific pelvic pain in the absence of signs of infection or other obvious local pathology for at least three of the last 6 months. Evidence for treatment approach is limited. So the aim of this study is to investigate the effect of extracorporeal shock wave therapy (ESWT) combined with pharmacotherapy in the treatment of CP/CPPS.
MATERIALS AND METHODS


In this randomized clinical  trial, 31 patients with CP/CPPS were investigated in two groups: the intervention group (n=16) was treated with a combination of an alpha-blocker, an anti-inflammatory agent, a muscle relaxant and a short course of antibiotic in combination with 4 sessions of focused ESWT (a protocol of 3000 impulses, 0.25 mJ/mm2  and 3 Hz of frequency). The control group (n=15) received the aforementioned pharmacotherapy with 4 sessions of sham-ESWT . Follow-up was performed 4 and 12 weeks following ESWT by using the Visual Analogue Scale (VAS), International index of Erectile function (IIEF) 5, National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires. Post void residual (PVR) urine and maximum flow rate (Qmax) were also assessed in both groups.
RESULTS


The patients mean age was 43.7 ±12.6 years. In both groups, the mean scores of NIH-CPSI (total and sub-domains) and VAS showed statistically significant improvements after 4 and 12 weeks compared to the baseline (P < .001). In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved (P < .001).  There was a significant improvement in NIH-CPSI (mean difference: 1.1) and VAS scores (mean difference: 1.1) in the intervention group as compared to the control group (P < .01). Qmax, PVR and IIEF score were not statistically different in the two groups.
CONCLUSION


ESWT in combination with pharmacotherapy could improve the treatment outcome in patients with CP/CPPS.",2020,"In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved.","['Chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS', 'patients with CP/CPPS', 'Chronic Pelvic Pain Syndrome ', 'patients mean age was 43.7 ±12.6 years', '31 patients with CP/CPPS']","['alfa-blocker, an anti-inflammatory agent, a muscle relaxant and a short course of antibiotic in combination with 4 sessions of focused ESWT', 'aforementioned pharmacotherapy with 4 sessions of sham-ESWT ', 'extracorporeal shock wave therapy (ESWT) combined with pharmacotherapy', 'Extracorporeal Shockwave Therapy Combined with Drug Therapy']","['Visual Analogue Scale (VAS), International index of Erectile function (IIEF) 5, National Institutes of Health-Chronic Prostatitis Symptom Index', 'IPSS', 'NIH-CPSI', 'mean scores of NIH-CPSI (total and sub-domains) and VAS', 'VAS scores', 'Qmax, PVR and IIEF score', 'NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires', 'Post void residual (PVR) urine and maximum flow rate (Qmax']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}]",31.0,0.0426641,"In the intervention group, IPSS (mean difference: 4.25) and Qmax (mean difference: 2.22) were also significantly improved.","[{'ForeName': 'Seyed Mansour', 'Initials': 'SM', 'LastName': 'Rayegani', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. rayegani@gmail.com.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Razzaghi', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Raeissadat', 'Affiliation': 'Clinical Development Research Center of Shahid Modarres Hospital, Physical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Allameh', 'Affiliation': 'Center of Excellence in Training Laser Application in Medicine, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Eliaspour', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Abedi', 'Affiliation': 'Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Javadi', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Rahavian', 'Affiliation': 'Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4673']
482,32180212,Role of Sexual Intercourse after Shockwave Lithotripsy for Distal Ureteral Stones: A Randomized Controlled Trial.,"PURPOSE


To explore whether sexual intercourse is beneficial to the clinical outcome of SWL for ureteral calculi of 7-15 mm in the distal ureter.
MATERIALS AND METHODS


Between March 2016 and January 2017, 225 patents with a stone (7-15 mm) in distal ureter were randomly divided into three groups after SWL: Group 1 was asked to have sexual intercourse at least three times a week, Group 2 was administered tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls. Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse were recorded in 2 weeks.
RESULTS


70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study. At the end of the first week and the second week, the stone free rates for Group 1 (68.6%, 80.0%) and Group 2 (69.0%, 81.7%) were approximately the same, but were significantly higher than Group 3 (50.0%, 63.2%) (P = .031, P = .022). The VAS scores of Groups 1 and 2 were slightly higher than those of Group 3 (P = .233). The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015). At the end of the second week, the incidence of steinstrasse in Groups 1 and 2 was significantly lower (2.9%, 2.8% vs 11.8%) (P = .034).
CONCLUSION


At least three sexual intercourses per week after SWL can effectively improve the stone free rate, reduce the formation of steinstrasse and relieve renal colic. It provides a choice for urologists in the SWL treatment of lower ureteral calculi.",2020,The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015).,"['Distal Ureteral Stones', 'Between March 2016 and January 2017', '70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study', '225 patents with a stone (7-15 mm) in distal ureter']","['tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls', 'Shockwave Lithotripsy']","['incidence of steinstrasse', 'VAS scores', 'stone free rates', 'formation of steinstrasse and relieve renal colic', 'Sexual Intercourse', 'Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse', 'visited the emergency room for pain']","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0403718', 'cui_str': 'Steinstrasse (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",,0.0189539,The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015).,"[{'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China. lichen0612@163.com.""}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Hua', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ""Department of Urology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200011, China.""}]",Urology journal,['10.22037/uj.v0i0.5400']
483,31388222,Assessing the impact of an asset-based intervention on educational outcomes of orphaned children and adolescents: findings from a randomised experiment in Uganda.,"This paper examines the effect of an asset-based intervention on academic performance and school transition among orphaned and vulnerable children in Uganda. Participants were randomly assigned to either the control arm or two treatment arms receiving an asset-based intervention. Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm. Programmes which target financial insecurity may have a positive impact on the educational achievement and progression of orphaned children. There is a need to consider incorporating asset-based interventions within the development of educational policy, especially in low-income countries.",2019,Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm.,"['orphaned and vulnerable children in Uganda', 'orphaned children and adolescents']","['control arm or two treatment arms receiving an asset-based intervention', 'asset-based intervention']",['academic performance and school transition'],"[{'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0036375', 'cui_str': 'School'}]",,0.0422924,Participants in the treatment arms scored better grades; and had higher odds of transitioning to post-primary education relative to the control arm.,"[{'ForeName': 'Nabunya', 'Initials': 'N', 'LastName': 'Proscovia', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Namatovu', 'Initials': 'N', 'LastName': 'Phionah', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Damulira', 'Initials': 'D', 'LastName': 'Christopher', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kivumbi', 'Initials': 'K', 'LastName': 'Apollo', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mukasa', 'Initials': 'M', 'LastName': 'Miriam', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Nattabi', 'Initials': 'N', 'LastName': 'Jennifer', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Ssewamala M', 'Initials': 'SM', 'LastName': 'Fred', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}]",Asia Pacific journal of social work and development,['10.1080/02185385.2019.1575271']
484,31826936,Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times.,"OBJECTIVE


In implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection.
METHODS


The Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms-long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models.
RESULTS


Overall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
CONCLUSIONS


In patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm.
CLINICAL TRIAL REGISTRATION


NCT00617175.",2020,"Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
","['1902 patients (304 women, 65±11 years']","['implantable cardiac defibrillator therapy', 'implantable cardiac defibrillators (ICDs']","['lower risk of ICD therapy', 'inappropriate therapies and mortality rate', 'overall ICD therapies and appropriate ICD therapies', 'incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",1902.0,0.219931,"Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).
","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Gasparini', 'Affiliation': 'Electrophysiology and Pacing Unit, Humanitas Clinical and Research Hospital, IRCCS, Rozzano, Italy maurizio.gasparini@humanitas.it.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kloppe', 'Affiliation': 'Cardiology and Angiology, Bergmannsheil, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Lunati', 'Affiliation': ""Cardiology Department, Niguarda Ca' Granda Hospital, Milano, Italy.""}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cardiology Department, University of Pennsylvania, Cleveland, Ohio, USA.'}, {'ForeName': 'Jose B', 'Initials': 'JB', 'LastName': 'Martinez-Ferrer', 'Affiliation': 'Department of Cardiology, Hospital Universitario de Araba, Vitoria, Alava, Spain.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hersi', 'Affiliation': 'College of Medicine, King Saud University, Riyadh, Riyadh Province, Saudi Arabia.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gulaj', 'Affiliation': 'Department of Cardiology, MSWiA Hospital, Bialystok, Poland.'}, {'ForeName': 'Maurits C E F', 'Initials': 'MCEF', 'LastName': 'Wijffels', 'Affiliation': 'Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Arenal', 'Affiliation': 'Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Mangoni di Santo Stefano', 'Affiliation': 'Study and Scientific Solutions, Medtronic Core Clinical Solutions, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Proclemer', 'Affiliation': 'Department of Cardiology, Azienda Ospedaliera Universitaria S Maria della Misericordia, Udine, Friuli-Venezia Giulia, Italy.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315650']
485,31874454,How accuracy of foot-placement is affected by the size of the base of support and crutch support in stroke survivors and healthy adults.,"BACKGROUND


The high prevalence of falls due to trips and slips following stroke may signify difficulty controlling balance and adjusting foot-placement in response to the environment. We know very little about how controlling foot-placement is affected by balance requirements and the effects of stroke. Therefore, in this study the research question is how foot-placement control is affected by balance support from crutches and reducing or enlarging the base of support. By understanding how foot-placement control and balance deficits following stroke interact, rehabilitation efforts can be more effectively targeted towards the cause of poor mobility.
METHODS


Young (N=13, 30±6 years) and older (N=10, 64±8 years) healthy adults and stroke survivors (N=11, 67±9 years) walked to targets on an instrumented treadmill with or without crutch support for balance. Targets were randomized to either reduce or increase the base of support in the antero-posterior (AP) or medio-lateral (ML) direction. Mean and absolute foot-placement error were measured using motion analysis. These outcomes were compared using repeated measures ANCOVA with walking speed as a covariate.
RESULTS


Overall, stroke survivors missed more targets (9.1±2.3%, p=0.001) than young (1.0±2.5%) and older (0.2±2.1%) healthy adults (p=0.001). However, there were no significant differences between groups in foot-placement error. Crutch support reduced both AP and ML foot-placement error (p=<0.001, AP 5.2±0.5cm unsupported, 4.1±0.4cm supported, ML 2.3±0.2cm unsupported, 1.9±0.2cm supported) for all participants. Interaction effects indicate crutch support reduced foot-placement error more when narrowing (unsupported 2.8±0.2cm, supported 1.8±0.2cm) than widening (unsupported 2.6±0.4cm, supported 2.4±0.4cm) steps (p<0.001), SIGNIFICANCE: Stroke survivors have greater difficulty accurately adjusting steps in response to the environment. Crutch support reduces foot-placement error for all steps, but particularly when narrowing foot-placement. These results provide support for the implication of walking aids, which support balance to improve ability to adjust footplacement in response to the environment.",2020,"Crutch support reduced both AP and ML foot-placement error (p=<0.001, AP 5.2±0.5cm unsupported, 4.1±0.4cm supported, ML 2.3±0.2cm unsupported, 1.9±0.2cm supported) for all participants.","['stroke survivors and healthy adults', 'Young (N=13, 30±6 years) and older (N=10, 64±8 years) healthy adults and stroke survivors (N=11, 67±9 years) walked to targets on an']",['instrumented treadmill with or without crutch support for balance'],"['Mean and absolute foot-placement error', 'foot-placement error', 'AP and ML foot-placement error']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0010397', 'cui_str': 'Crutches'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.065897,"Crutch support reduced both AP and ML foot-placement error (p=<0.001, AP 5.2±0.5cm unsupported, 4.1±0.4cm supported, ML 2.3±0.2cm unsupported, 1.9±0.2cm supported) for all participants.","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'van der Veen', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA. Electronic address: smvanderveen@vcu.edu.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hammerbeck', 'Affiliation': 'University of Manchester, Manchester, United Kingdom. Electronic address: ulrike.hammerbeck@manchester.ac.uk.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Hollands', 'Affiliation': 'Salford University, School of Health Science, Salford, United Kingdom. Electronic address: k.hollands@salford.ac.uk.'}]",Gait & posture,['10.1016/j.gaitpost.2019.12.007']
486,31881480,Investigating prismatic adaptation effects in handgrip strength and in plantar pressure in healthy subjects.,"BACKGROUND


Prismatic Adaptation (PA) is a visuomotor procedure inducing a shift of the visual field that has been shown to modulate activation of a number of brain areas, in posterior (i.e. parietal cortex) and anterior regions (i.e. frontal cortex). This neuromodulation could be useful to study neural mechanisms associated with either postural measures such as the distribution of plantar pressure or to the generation of muscle strength. Indeed, plantar pressure distribution is associated to activation of high-level cognitive mechanisms taking place within the posterior regions of the brain dorsal stream, especially of the right hemisphere. Conversely, hand force mostly rely on sensorimotor mechanisms, fulfilled by anterior regions of the brain and involving both hemispheres.
RESEARCH QUESTION


Since PA effects have been reported to affect both sensorimotor and higher level cognitive processes, is it possible to hypothesize a modulation of both hands strenght and plantar pressure after PA?
METHODS


Forty-six healthy subjects (male = 23; mean age = 25 ± 3 years) were randomly divided into two groups: a leftward prismatic adaptation group (l-PA) and a rightward prismatic adaptation group (r-PA). Hand strength and plantar pressure were assessed, immediately before and after PA, using the handgrip task and baropodometric measurement, respectively.
RESULTS


Both l-PA and r-PA induced a significant decrease of strength in the hand contralateral to the lenses deviation side. Only r-PA was associated with an increase of the forefoot plantar pressure in both feet. Modulation of interhemispheric inhibitory processes at sensorimotor and higher cognitive level may account for the present results.
SIGNIFICANCE


PA exerts effects on body posture and hand strength relying on different mechanisms. The PA effects on hand strength are probably related to the modulation of interhemispheric inhibition of sensorimotor processes, involving both hemispheres. The PA effects on body posture are probably related to modulation of body representation, involving mainly the right hemisphere.",2020,"RESULTS


Both l-PA and r-PA induced a significant decrease of strength in the hand contralateral to the lenses deviation side.","['Forty-six healthy subjects (male\u202f=\u202f23; mean age\u202f=\u202f25\u202f±\u202f3 years', 'healthy subjects']","['Prismatic Adaptation (PA', 'leftward prismatic adaptation group (l-PA) and a rightward prismatic adaptation group (r-PA']","['body posture and hand strength relying', 'strength', 'Hand strength and plantar pressure', 'forefoot plantar pressure', 'plantar pressure']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}]",46.0,0.0139126,"RESULTS


Both l-PA and r-PA induced a significant decrease of strength in the hand contralateral to the lenses deviation side.","[{'ForeName': 'Rosario Emanuele', 'Initials': 'RE', 'LastName': 'Bonaventura', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Giustino', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Chiaramonte', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy.'}, {'ForeName': 'Andreina', 'Initials': 'A', 'LastName': 'Giustiniani', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy; NEUROFARBA Department, University of Firenze, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Smirni', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy; NeuroTeam Life and Sciences, Palermo, Italy. Electronic address: daniela.smirni@unipa.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Battaglia', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy; Regional Sport School of CONI Sicilia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Messina', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy; Postura LAB, Palermo, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Italy; NeuroTeam Life and Sciences, Palermo, Italy.'}]",Gait & posture,['10.1016/j.gaitpost.2019.12.022']
487,32079472,Probiotics maintain the intestinal microbiome homeostasis of the sailors during a long sea voyage.,"The challenging conditions encountered during long sea voyages increase the risk of health-threatening physiological and psychological stress for sailors compared with land-based workers. However, how the intestinal microbiota responds to a long sea voyage and whether there is a feasible approach for protecting gut health during sea voyage are still unexplored. Here, we designed a 30-d longitudinal study including a placebo group ( n  = 42) and a probiotic group ( n  = 40) and used shotgun metagenomic sequencing to explore the impacts of sea voyage on the intestinal microbiome of sailors. By comparing the intestinal microbiome of subjects in the placebo group at baseline (d 0) and at the end of the sea voyage (d 30), we observed an alteration in the intestinal microbiome during the long sea voyage based on the microbial structure; the results revealed an increase in the species  Streptococcus gordonii  and  Klebsiella pneumoniae  as well as a decrease in some functional features. However, the change in the microbial structure of sailors in the probiotic group between d 0 and d 30 was limited, which indicated a maintenance effect of probiotics on intestinal microbiome homeostasis. At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to  Bifidobacterium longum  and  Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and  Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics. The present study provided a feasible approach for protecting gut health during a long sea voyage.",2020,"At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to  Bifidobacterium longum  and  Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and  Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics.",[],"['Probiotics', 'probiotic group ( n  = 40) and used shotgun metagenomic sequencing', 'placebo']","['intestinal microbiome homeostasis', 'risk of health-threatening physiological and psychological stress']",[],"[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037003', 'cui_str': 'Shotguns'}, {'cui': 'C2717799', 'cui_str': 'Population Genomics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",,0.0335748,"At the metagenomic strain level, a generally positive correlation was observed between probiotics and the strains belonging to  Bifidobacterium longum  and  Bifidobacterium animalis , whereas a common negative correlation was observed between probiotics and  Clostridium leptum ; this result revealed the potential mechanism of maintaining intestinal microbiome homeostasis by probiotics.","[{'ForeName': 'Jiachao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Jinshan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'College of Animal Science, Qingdao Agricultural University , Qingdao, P. R. China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Lv', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'De', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, 971 Hospital , Qingdao, P. R. China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University , Hohhot, P. R. China.'}]",Gut microbes,['10.1080/19490976.2020.1722054']
488,31422789,Vertebral artery stenting to prevent recurrent stroke in symptomatic vertebral artery stenosis: the VIST RCT.,"BACKGROUND


Symptomatic vertebral artery (VA) stenosis has been associated with a markedly increased early risk of recurrent stroke. VA stenosis can be treated with stenting; however, there are few data from randomised controlled trials evaluating the efficacy of this treatment, and recent studies in intracranial stenosis have suggested that stenting may be associated with increased risk.
OBJECTIVE


The Vertebral artery Ischaemia Stenting Trial (VIST) was established to compare the risks and benefits of vertebral angioplasty and stenting with best medical treatment (BMT) alone for recently symptomatic VA stenosis.
DESIGN


VIST was a prospective, randomised, open, parallel, blinded end-point clinical trial.
SETTING


The trial was performed in 14 hospitals in the UK.
PARTICIPANTS


Recruitment began on 23 October 2008 and follow-up ended on 1 March 2016, by which time every patient had been followed up for at least 1 year. Participants had to have symptomatic vertebral stenosis of at least 50% resulting from presumed atheromatous disease. Both patients and clinicians were aware of treatment allocation; however, an independent adjudication committee, masked to treatment allocation, assessed all primary and secondary end points.
INTERVENTIONS


Participants were randomly assigned (1 : 1) to either vertebral angioplasty/stenting plus BMT ( n  = 91) or BMT alone ( n  = 88). A total of 182 patients were initially enrolled; however, three patients (two who withdrew after randomisation and one who did not attend after the initial randomisation visit) did not contribute any follow-up data and were excluded. None of these three patients had outcome events.
MAIN OUTCOMES AND MEASURES


The primary end point was the occurrence of fatal or non-fatal stroke in any arterial territory during follow-up.
RESULTS


The median follow-up was 3.5 (interquartile range 2.1-4.7) years. Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis. No perioperative complications occurred with extracranial stenting; two strokes occurred during intracranial stenting. The primary end point occurred in five patients (including one fatal stroke) in the stent group and in 12 patients (including two fatal strokes) in the medical group (giving a hazard ratio of 0.40, 95% confidence interval 0.14 to 1.13;  p  = 0.08), with an absolute risk reduction of 25 strokes per 1000 person-years.
LIMITATIONS


The study was underpowered because it failed to reach target recruitment. The high rate of non-confirmation of stenosis in the stented group of the trial was a second limitation.
CONCLUSIONS


The trial found no difference in risk of the primary end point between the two groups.
FUTURE


Post hoc analysis suggested that stenting could be associated with a reduced recurrent stroke risk in symptomatic VA and further studies are now required to confirm these findings, particularly in extracranial VA stenosis where complication rates with stenting were confirmed to be very low.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN95212240.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 41. See the NIHR Journals Library website for further project information. In addition, funding for the pilot phase was provided by the Stroke Association.",2019,"Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis.","['symptomatic vertebral artery stenosis', '182 patients were initially enrolled; however, three patients (two who withdrew after randomisation and one who did not attend after the initial randomisation visit) did not contribute any follow-up data and were excluded', 'Recruitment began on 23 October 2008 and follow-up ended on 1 March 2016, by which time every patient had been followed up for at least 1 year', '14 hospitals in the UK']","['Vertebral artery stenting', 'vertebral angioplasty and stenting with best medical treatment (BMT) alone', 'vertebral angioplasty/stenting plus BMT', 'BMT alone']","['symptomatic vertebral stenosis', 'intracranial stenosis', 'one fatal stroke', 'perioperative complications', 'high rate of non-confirmation of stenosis', 'occurrence of fatal or non-fatal stroke', 'extracranial stenosis']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0265103', 'cui_str': 'Vertebral Artery Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0042559', 'cui_str': 'Vertebral Artery'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}]",182.0,0.172526,"Of the 61 patients who were stented, 48 (78.7%) had extracranial stenosis and 13 (21.3%) had intracranial stenosis.","[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Markus', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susanna C', 'Initials': 'SC', 'LastName': 'Larsson', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dennis', 'Affiliation': 'Patient representative, London, UK.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Kuker', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ursula G', 'Initials': 'UG', 'LastName': 'Schulz', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clifton', 'Affiliation': ""Department of Neuroradiology, St George's Hospital, London, UK.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23410']
489,31313331,Social and Situational Party Characteristics Associated With High-Intensity Alcohol Use Among Youth and Young Adults.,"BACKGROUND


Rates of high-intensity drinking, which is alcohol consumption that exceeds standard heavy drinking levels, have increased in recent years and peak in young adulthood. To identify modifiable environmental targets for prevention of high-intensity drinking, we identified characteristics of parties attended by youth and young adults that were associated with high-intensity drinking and the consequences of this excessive form of drinking.
METHODS


Data are from 15- to 20-year-old participants in an online survey (n = 2,442; 55.4% female, 74.8% White) who resided in 24 communities across 7 states that were a part of a community randomized intervention trial to reduce the incidence and consequences of underage drinking parties. We used multinomial logistic regression to predict level of drinking by 6 party characteristics (size, location, age and gender composition, supervision, others' drinking behavior), and to predict 6 consequences (hangover, not remember event, passed out, punished by parents, broke something/got in fight, and sex against will) from level of drinking. We tested study hypotheses in 2 models, one that used a single binge drinking threshold (below binge vs. at or above binge level) and one that additionally used a high-intensity drinking level (below binge, 1 to 2 times binge, 2+ times binge level).
RESULTS


We found that larger party size and a mostly male composition were unique predictors of high-intensity drinking when compared to those who consumed 1 to 2 times the binge drinking level. Odds of passing out, not remembering the drinking event, breaking/damaging property, or getting in a fight were more than double for high-intensity drinkers compared to standard binge level drinkers.
CONCLUSIONS


Results from this study indicate there are unique precursors and consequences of high-intensity alcohol consumption among youth and young adults. These environmental factors associated with high-risk drinking contexts can be used to develop prevention strategies to mitigate the harms associated with excessive alcohol consumption.",2019,We found that larger party size and a mostly male composition were unique predictors of high-intensity drinking when compared to those who consumed 1 to 2 times the binge drinking level.,"['youth and young adults', 'Data are from 15- to 20-year-old participants in an online survey (n\xa0', 'Youth and Young Adults', '2,442; 55.4% female, 74.8% White) who resided in 24 communities across 7 states']",[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],[],6.0,0.0226111,We found that larger party size and a mostly male composition were unique predictors of high-intensity drinking when compared to those who consumed 1 to 2 times the binge drinking level.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Cox', 'Affiliation': 'Department of Health Education & Promotion, (MJC, KLE), East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Egan', 'Affiliation': 'Department of Health Education & Promotion, (MJC, KLE), East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Cynthia K', 'Initials': 'CK', 'LastName': 'Suerken', 'Affiliation': 'Department of Biostatistics and Data Science, (CKS, BAR), Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, (CKS, BAR), Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Eunyoung Y', 'Initials': 'EY', 'LastName': 'Song', 'Affiliation': 'Department of Social Sciences and Health Policy, (EYS, KGW, MW), Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kimberly G', 'Initials': 'KG', 'LastName': 'Wagoner', 'Affiliation': 'Department of Social Sciences and Health Policy, (EYS, KGW, MW), Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wolfson', 'Affiliation': 'Department of Social Sciences and Health Policy, (EYS, KGW, MW), Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14143']
490,32013174,Effectiveness and Durability of Transfer Training in Fencing.,"This paper reports the results of an experiment that aimed to study transfer training in fencing. Fencers from the experimental group underwent six-week transfer training while those from the control group underwent regular fencing training. The fencers' performance was analyzed thrice: before the experimental training (pretest), immediately after it (posttest), and four weeks after it (retention test). Using a device that simulates fencing moves and analyzes the accuracy of such performance, participants completed, with both hands, three tests related to straight thrust accuracy. While no differences in hand grip strength was observed between the two groups across the three tests, significant differences occurred in terms of their performance on the device. The groups did not differ in the pretests and the retention tests. However, the fencers from the experimental group generally performed better in postests than prestests. These results show that bilateral transfer can be effective in foil fencing training, although its positive effects are short-term. In order to be effective, transfer training should be used as a regular training tool.",2020,"While no differences in hand grip strength was observed between the two groups across the three tests, significant differences occurred in terms of their performance on the device.",[],"['regular fencing training', 'Transfer Training']",['hand grip strength'],[],"[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0203971', 'cui_str': 'Transfer training (procedure)'}]","[{'cui': 'C1293900', 'cui_str': 'Hand grip'}]",,0.012776,"While no differences in hand grip strength was observed between the two groups across the three tests, significant differences occurred in terms of their performance on the device.","[{'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Witkowski', 'Affiliation': 'Adam Mickiewicz University in Poznań, Zagajnikowa 9, 60-568 Poznań, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Bojkowski', 'Affiliation': 'Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Karpowicz', 'Affiliation': 'Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Opole University of Technology, Prószkowska 76, 45-758 Opole, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Bronikowski', 'Affiliation': 'Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Tomczak', 'Affiliation': 'Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17030849']
491,32156477,Feasibility and impact of the implementation of a clinical scale-based sedation-analgesia protocol in severe burn patients undergoing mechanical ventilation. A before-after bi-center study.,"BACKGROUND


Severe burn patients undergo prolonged administration of sedatives and analgesics for burn care. There are currently no guidelines for the dose adaptation of sedation-analgesia in severe burn patients.
METHODS


We performed a before-after 2-center study to demonstrate the feasibility and efficacy of a sedation-analgesia scale-based protocol in severely burned patients receiving ≥24h of invasive mechanical ventilation. Before the intervention, continuous infusion of hypnotic and morphine derivatives was continued. During the Intervention phase, general anesthesia was relayed from day 1 by RASS/BPS-titrated continuous infusion of hypnotic and morphine derivatives and with short half-life drugs adminstered for daily burn dressings. The primary outcome was the duration of invasive mechanical ventilation in the ICU.
RESULTS


Eighty-seven (46.2%) patients were included in the Control phase and 101 (53.7%) in the Intervention phase. The median burned cutaneous surface was 20% [11%-38%] and median ABSI was 7 [5-9]. The durations of hypnotic and opioid infusions were not statistically different between the 2 phases (8 days [2-24] vs. 6 days [2-17] (P=0.3) and 17 days [4-32] vs. 8 days [3-23] (P=0.06), respectively). The duration of mechanical ventilation was 14 days [3-29] in the Control phase and 7 days [2-24] in the Intervention phase (P=0.7). When taking into account the competition between mortality and weaning from mechanical ventilation, we found no significant difference between the 2 phases (Gray test, P=0.4). The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6). Eighteen (20.7%) patients died in the Control phase, and 18 (18%) in the Intervention phase (P=0.6).
CONCLUSION


Scale-based lightening of continuous sedation-analgesia with repeated short general anesthesia for dressing is feasible in severe burn patients but failed to demonstrate a decrease in the duration of invasive mechanical ventilation.",2020,The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6).,"['Eighty-seven (46.2', 'severe burn patients undergoing mechanical ventilation', 'severe burn patients', 'Severe burn patients undergo prolonged administration of sedatives and analgesics for burn care', 'severely burned patients receiving ≥24h of invasive mechanical ventilation']","['clinical scale-based sedation-analgesia protocol', 'sedation-analgesia scale-based protocol']","['duration of mechanical ventilation', 'durations of hypnotic and opioid infusions', 'duration of invasive mechanical ventilation', 'feasibility and efficacy', 'median burned cutaneous surface', 'median ABSI', 'duration of invasive mechanical ventilation in the ICU']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0344106', 'cui_str': 'Sedative therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.0569331,The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6).,"[{'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Cinotti', 'Affiliation': 'Department of Anesthesia and Critical Care, Hôpital Guillaume et René Laennec, University Hospital of Nantes, Boulevard Jacques Monod, Saint-Herblain 44800, France. Electronic address: raphael.cinotti@chu-nantes.fr.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Besnard', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Desmedt', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Ronan Le', 'Initials': 'RL', 'LastName': 'Floch', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Perrot', 'Affiliation': 'Department of Plastic and Burn Surgery, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Bekara', 'Affiliation': 'Department of Plastic and Burn Surgery, Montpellier University and Montpellier Teaching Hospital, Hôpital Lapeyronie 191, Avenue du Doyen Gaston Giraud, Montpellier Cedex 5, Montpellier 34295, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France; INSERM U1046, CNRS UMR9214, Hôpital Lapeyronie 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Université deMontpellier, Montpellier 34295, France.'}, {'ForeName': 'Romaric', 'Initials': 'R', 'LastName': 'Larcher', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Pierre-Joachim', 'Initials': 'PJ', 'LastName': 'Mahé', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': 'Department of Anesthesia and Critical Care, Centre Hospitalo-Universitaire, University Hospital of Poitiers, 2 rue de la Milétrie Poitiers 86021, France; INSERM SPHERE U1246 «MethodS for Patients-centered outcomes and HEalth REsearch», UFR des sciences pharmaceutiques, University of Nantes, University of Tours, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France; Laboratoire UPRES EA 3826 «Thérapeutiques cliniques et expérimentales des infections». University hospital of Nantes, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Jung', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France; Laboratoire UPRES EA 3826 «Thérapeutiques cliniques et expérimentales des infections». University hospital of Nantes, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.02.009']
492,32013175,A Feasibility Study Assessing Acceptability and Supply Issues of Distributing LPG Cookstoves and Gas Cylinders to Pregnant Women Living in Rural Bangladesh for Poriborton: The CHANge Trial.,"Our aim was to develop a protocol for a cluster randomised controlled trial to assess the impact of liquid petroleum gas (LPG) cooking compared to usual cooking on perinatal mortality in pregnant women in rural Bangladesh. We, therefore, aimed to assess the feasibility of the planned trial and the barriers/facilitators of distributing LPG to rural households. We conducted a feasibility study in rural Bangladesh using an iterative design. We included pregnant women, their families, and local LPG stakeholders. We distributed LPG to households for 3 months (3 cylinders) and assessed process issues, acceptability, and cooking/food behaviours. We interviewed LPG stakeholders, and conducted focus groups and in-depth interviews with the users. The initial distribution and uptake of LPG were hampered by process issues, most of these were due to the nonestablished supply chain in the study area. LPG cooking was very acceptable and all users reported a preference for continued use, fuel-sparing was heavily practiced. Safety concerns were an initial issue. LPG stakeholders reported that LPG demand differed by season. This study demonstrated the feasibility of our planned trial and the need for safety messages. These results are relevant beyond our trial, including for programs of LPG fuel promotion.",2020,"LPG cooking was very acceptable and all users reported a preference for continued use, fuel-sparing was heavily practiced.","['pregnant women in rural Bangladesh', 'rural Bangladesh', 'pregnant women, their families, and local LPG stakeholders', 'rural households', 'Pregnant Women Living in Rural Bangladesh for Poriborton']","['Distributing LPG Cookstoves and Gas Cylinders', 'liquid petroleum gas (LPG) cooking compared to usual cooking', 'LPG cooking']","['perinatal mortality', 'acceptability, and cooking/food behaviours']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C3463996', 'cui_str': 'Liquid Petroleum'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",,0.0813931,"LPG cooking was very acceptable and all users reported a preference for continued use, fuel-sparing was heavily practiced.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Raynes-Greenow', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Edward Ford Building (A27), Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Sajia', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Mohakhali, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Mohakhali, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Fariha', 'Initials': 'F', 'LastName': 'Tasnim', 'Affiliation': 'Maternal and Child Health Division, icddr,b, Mohakhali, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Monjura Khatun', 'Initials': 'MK', 'LastName': 'Nisha', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Edward Ford Building (A27), Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Thornburg', 'Affiliation': 'RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27707, USA.'}, {'ForeName': 'Sk Masum', 'Initials': 'SM', 'LastName': 'Billah', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Edward Ford Building (A27), Camperdown, NSW 2006, Australia.'}, {'ForeName': 'And Ashraful', 'Initials': 'AA', 'LastName': 'Alam', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Edward Ford Building (A27), Camperdown, NSW 2006, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17030848']
493,32019259,A Gamification-Based Intervention Program that Encourages Physical Activity Improves Cardiorespiratory Fitness of College Students: 'The Matrix rEFvolution Program'.,"The aim of the present study was to examine the effects of a gamification-based program on cardiorespiratory fitness (CRF) levels of college students. We divided 112 college students into an intervention group (IG) and a control group (CG). IG college students followed a 15-week gamification-based program, whereas CG followed traditional lectures. CRF was assessed using the 20-meter shuttle-run test. CRF significantly improved after the program in the IG compared to CG (d ≤ 0.94,  p  < 0.001). Only participants of IG had significant CRF improvements (d ≤ 0.87,  p  < 0.001) between pre- and post-assessments. In the IG, from the students who attended 100% of lectures, 87.8% met physical activity recommendations for 100% of weeks, whereas from those who attended <100%, only 26.7% met them them for 100% of weeks ( p  < 0.001). Participants who met recommendations 100% of weeks had a significant CRF improvement ( p  < 0.001). Motivating college students throughout innovative teaching methods (e.g., gamification) can lead to health improvements.",2020,"CRF significantly improved after the program in the IG compared to CG (d ≤ 0.94,  p  < 0.001).","['IG college students', '112 college students into an', 'College Students', 'Motivating college students', 'college students']","['gamification-based program', 'intervention group (IG) and a control group (CG']","['CRF improvements', 'physical activity recommendations', 'Physical Activity', 'CRF improvement', 'cardiorespiratory fitness (CRF) levels', 'CRF']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",112.0,0.0197781,"CRF significantly improved after the program in the IG compared to CG (d ≤ 0.94,  p  < 0.001).","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sports Science, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Isaac J', 'Initials': 'IJ', 'LastName': 'Pérez-López', 'Affiliation': 'Educación física y transformación social, SEJ546 Research Group, Department of Physical Education and Sports, Faculty of Sports Science, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Esteban-Cornejo', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sports Science, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Delgado-Fernández', 'Affiliation': 'PA-HELP ""Physical Activity for Health Promotion, CTS-1018"" Research Group, Department of Physical Education and Sports, Faculty of Sports Science, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17030877']
494,31898319,"Bortezomib, cyclophosphamide, dexamethasone versus lenalidomide, cyclophosphamide, dexamethasone in multiple myeloma patients at first relapse.","Bortezomib- and lenalidomide-containing regimens are well-established therapies in multiple myeloma (MM). However, despite their extensive use, head-to-head comparisons have never been performed. Therefore, we compared bortezomib and lenalidomide in fixed-duration therapies. In this open-label, phase III study, we randomized MM patients at first relapse to receive either nine cycles of bortezomib plus cyclophosphamide plus dexamethasone (VCD) or lenalidomide plus cyclophosphamide plus dexamethasone (RCD). The primary endpoint was achievement of a very good partial response (VGPR) or better at six weeks after nine treatment cycles. From March 2011 to February 2015, 155 patients were randomized. VGPR or better was achieved by 12 patients (15%) in the VCD arm and 14 patients (18%) in the RCD arm (P = 0·70). Median progression-free survival (PFS) was 16·3 (95% CI: 12·1-22·4) with VCD and 18·6 months (95% CI: 14·7-25·5) with RCD, and the two-year overall survival (OS) was 75% (95% CI: 66-86%) and 74% (95% CI: 64-85%) respectively. In subgroup analyses, no differences in PFS were observed in bortezomib- and lenalidomide-naïve patients, nor in patients who received a bortezomib-based regimen in first line. Adverse events were consistent with the well-established safety profiles of both drugs. Bortezomib and lenalidomide treatments were equally effective in terms of depth of response, PFS, and OS in MM patients at first relapse.",2020,"Bortezomib and lenalidomide treatments were equally effective in terms of depth of response, PFS, and OS in MM patients at first relapse.","['From March 2011 to February 2015, 155 patients were randomized', 'multiple myeloma patients at first relapse']","['Bortezomib- and lenalidomide-containing regimens', 'Bortezomib and lenalidomide', 'Bortezomib, cyclophosphamide, dexamethasone versus lenalidomide, cyclophosphamide, dexamethasone', 'bortezomib and lenalidomide', 'bortezomib', 'bortezomib plus cyclophosphamide plus dexamethasone (VCD) or lenalidomide plus cyclophosphamide plus dexamethasone (RCD']","['depth of response, PFS, and OS', 'Median progression-free survival (PFS', 'PFS', 'VGPR', 'Adverse events', 'overall survival (OS', 'achievement of a very good partial response (VGPR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3641222', 'cui_str': 'Very good (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",155.0,0.171546,"Bortezomib and lenalidomide treatments were equally effective in terms of depth of response, PFS, and OS in MM patients at first relapse.","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Corso', 'Affiliation': 'Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Università di Pavia, Pavia, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology, Papa Giovanni XXIII hospital, Bergamo, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ardoino', 'Affiliation': 'Istituto di Ricerche Farmacologiche ""Mario Negri"" - IRCCS, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pezzatti', 'Affiliation': 'Hematology, San Gerardo hospital, Monza, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carniti', 'Affiliation': 'Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'DISM, University of Udine, Udine, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Gherlinzoni', 'Affiliation': ""Hematology, Ca' Foncello hospital, Treviso, Italy.""}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Department of Medicine, Hematology and Clinical Immunology Branch, Padua University School of Medicine, Padua, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sammassimo', 'Affiliation': 'Hematoncology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Marcatti', 'Affiliation': 'Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nozza', 'Affiliation': 'Oncology and Hematology Department, Istituto Clinico Humanitas, Rozzano (MI), Milan, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Crippa', 'Affiliation': 'Hematology, Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': ""Department of Oncology/Hematology, Niguarda Ca' Granda Hospital, Milan, Italy.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baldini', 'Affiliation': ""Hematology/Bone Marrow Transplantation Unit, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico Ca'Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",British journal of haematology,['10.1111/bjh.16287']
495,31265139,Evaluation of Tailored Falls Education on Older Adults' Behavior Following Hospitalization.,"BACKGROUND


Older adults recently discharged from the hospital are known to be at risk of functional decline and falls. This study evaluated the effect of a tailored education program provided in the hospital on older adult engagement in fall prevention strategies within 6 months after hospital discharge.
METHODS


A process evaluation of a randomized controlled trial that aimed to improve older adult fall prevention behaviors after hospital discharge. Participants (n = 390) were aged 60 years and older with good cognitive function (greater than 7 of 10 Abbreviated Mental Test Score), discharged home from three hospital rehabilitation wards in Perth, Australia. The primary outcomes were engagement in fall prevention strategies, including assistance with daily activities, home modifications, and exercise. Data were analyzed using generalized linear modeling.
RESULTS


There were 76.4% (n = 292) of participants who completed the final interview (n = 149 intervention, n = 143 control). There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3). There was a high proportion of unmet ADL needs within both groups, and levels of participant dependency remained higher at 6 months compared to baseline levels at admission. The proportion of all participants who engaged in exercise following hospital discharge increased by 30%; however, the mean duration of exercise reduced from 3 hours per week at baseline to 1 hour per week at 6-month follow-up (SD = 1.12 hours per week).
CONCLUSION


Tailored education did not increase older adult engagement in fall prevention strategies after hospital discharge compared to usual care. Further research is required to evaluate older adults' capacity to change their behaviors once they return home from hospital, which may enable a safer recovery of their independence. J Am Geriatr Soc 67:2274-2281, 2019.",2019,"There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3).","['Older adults', 'Participants (n = 390) were aged 60\u2009years and older with good cognitive function (greater than 7 of 10 Abbreviated Mental Test Score), discharged home from three hospital rehabilitation wards in Perth, Australia', 'older adult engagement in fall prevention strategies within 6 months after hospital discharge', ""Older Adults' Behavior Following Hospitalization"", 'older adult fall prevention behaviors after hospital discharge']","['Tailored Falls Education', 'tailored education program']","['mean duration of exercise', 'engagement in fall prevention strategies, including assistance with daily activities, home modifications, and exercise', 'receiving instrumental activity of daily living (IADL) assistance', 'hospital discharge', 'completion of home modifications']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2960765', 'cui_str': 'Abbreviated mental test score'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1321116', 'cui_str': 'Fall prevention behavior'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",390.0,0.201407,"There were no significant differences between groups in engagement in fall prevention strategies, including receiving instrumental activity of daily living (IADL) assistance (adjusted odds ratio [AOR] = 1.3 [95% confidence interval {CI} = 0.7-2.1]; P = .3), completion of home modifications (AOR = 1.2 [95% CI = 0.7-1.9]; P = .4), and exercise (AOR = 1.3 [95% CI = 0.7-2.2]; P = .3).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Naseri', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope and La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Western Australian Centre for Health and Ageing, University of Western Australia, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, Geriatric Research Education and Clinical Center, Gainesville, Florida.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health and Ageing, Centre for Medical Research, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Netto', 'Affiliation': 'School of Occupational Therapy and Social Work, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Den-Ching A', 'Initials': 'DA', 'LastName': 'Lee', 'Affiliation': 'Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Francis-Coad', 'Affiliation': 'School of Physiotherapy, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Waldron', 'Affiliation': 'Department of Geriatric Rehabilitation, Armadale Health Service, Department of Health, Mount Nasura, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Boudville', 'Affiliation': 'Department of Aged Care and Rehabilitation, St John of God Health Care, Midland, Western Australia, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Sciences, Faculty of Health Science, Curtin University, Perth, Western Australia, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16053']
496,31950979,"Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial.","Importance


It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock.
Objective


To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock.
Design, Setting, and Participants


Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019.
Interventions


Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
Main Outcomes and Measures


The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality.
Results


Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported.
Conclusions and Relevance


In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03333278.",2020,"No serious adverse events were reported.
","['Patients With Septic Shock', '216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63', '10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock', 'The first patient was enrolled on May 8, 2018, and the last on July 9, 2019', 'patients with septic shock']","['intravenous vitamin C, hydrocortisone, and thiamine', 'intravenous hydrocortisone', 'hydrocortisone alone', 'vitamin C, hydrocortisone, and thiamine', 'intravenous vitamin C', 'thiamine', 'hydrocortisone', 'Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone']","['Time alive and vasopressor free', 'Ninety-day mortality', 'duration of time alive and free of vasopressor administration up to day 7', 'serious adverse events', 'duration of time alive and free of vasopressor administration', 'Time Alive and Free of Vasopressor Support', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",216.0,0.416565,"No serious adverse events were reported.
","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Frei', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Edney', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hunt', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Judd', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Forbes', 'Initials': 'F', 'LastName': 'McGain', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Hudson', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dhiraj Bhatia', 'Initials': 'DB', 'LastName': 'Dwivedi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Peppin', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Orosz', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22176']
497,31713863,A randomised controlled trial of extended anticoagulation treatment versus standard treatment for the prevention of recurrent venous thromboembolism (VTE) and post-thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (the ExACT study).,"Venous thromboembolism (VTE) is prevalent and impactful, with a risk of death, morbidity and recurrence. Post-thrombotic syndrome (PTS) is a common consequence and associated with impaired quality of life (QoL). The ExACT study was a non-blinded, prospective, multicentred randomised controlled trial comparing extended versus limited duration anticoagulation following a first unprovoked VTE (proximal deep vein thrombosis or pulmonary embolism). Adults were eligible if they had completed ≥3 months anticoagulation (remaining anticoagulated). The primary outcome was time to first recurrent VTE from randomisation. The secondary outcomes included PTS severity, bleeding, QoL and D-dimers. Two-hundred and eighty-one patients were recruited, randomised and followed up for 24 months (mean age 63, male:female 2:1). There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation [2·75 vs. 13·54 events/100 patient years, adjusted hazard ratio (aHR) 0·20 (95% confidence interval (CI): 0·09 to 0·46, P < 0·001)] with a non-significant increase in major bleeding [3·54 vs. 1·18 events/100 patient years, aHR 2·99 (95% CI: 0·81-11·05, P = 0·10)]. Outcomes of PTS and QoL were no different between groups. D-dimer results (on anticoagulation) did not predict VTE recurrence. In conclusion, extended anticoagulation reduced VTE recurrence but did not reduce PTS or improve QoL and was associated with a non-significant increase in bleeding. Results also suggest very limited clinical utility of D-dimer testing on anticoagulated patients.",2020,"There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation [2·75 vs. 13·54 events/100 patient years, adjusted hazard ratio (aHR) 0·20","['patients being treated for a first episode of unprovoked VTE (the ExACT study', 'Two-hundred and eighty-one patients were recruited, randomised and followed up for 24\xa0months (mean age 63, male:female 2:1', 'anticoagulated patients', 'Adults were eligible if they had completed ≥3\xa0months anticoagulation (remaining anticoagulated']",['extended anticoagulation treatment versus standard treatment'],"['VTE recurrence', 'PTS and QoL', 'PTS severity, bleeding, QoL and D-dimers', 'quality of life (QoL', 'major bleeding', 'recurrent venous thromboembolism (VTE) and post-thrombotic syndrome', 'bleeding', 'recurrent VTE', 'time to first recurrent VTE', 'Venous thromboembolism (VTE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0277919', 'cui_str': 'Venous Stasis Syndrome'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",281.0,0.28395,"There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation [2·75 vs. 13·54 events/100 patient years, adjusted hazard ratio (aHR) 0·20","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fletcher', 'Affiliation': 'Institute of Applied Health Research, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Applied Health Research, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gardiner', 'Affiliation': 'Haemostasis Research Unit (HRU), Department of Haematology, University College London, London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Roalfe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Institute of Applied Health Research, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'McCahon', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Heritage', 'Affiliation': 'Institute of Applied Health Research, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shackleford', 'Affiliation': 'Institute of Applied Health Research, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Fd Richard', 'Initials': 'FR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitzmaurice', 'Affiliation': 'Unit of Academic Primary Care, Warwick Medical School, University of Warwick, Coventry, UK.'}]",British journal of haematology,['10.1111/bjh.16275']
498,31097078,Manualised cognitive-behavioural therapy in treating depression in advanced cancer: the CanTalk RCT.,"BACKGROUND


With a prevalence of up to 16.5%, depression is one of the commonest mental disorders in people with advanced cancer. Depression reduces the quality of life (QoL) of patients and those close to them. The National Institute for Health and Care Excellence (NICE) guidelines recommend treating depression using antidepressants and/or psychological treatments, such as cognitive-behavioural therapy (CBT). Although CBT has been shown to be effective for people with cancer, it is unclear whether or not this is the case for people with advanced cancer and depression.
OBJECTIVES


To assess the clinical effectiveness and cost-effectiveness of treatment as usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU for people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks.
DESIGN


Parallel-group, single-blind, randomised trial, stratified by whether or not an antidepressant was prescribed, comparing TAU with CBT plus TAU.
SETTING


Recruitment took place in oncology, hospice and primary care settings. CBT was delivered in IAPT centres or/and over the telephone.
PARTICIPANTS


Patients ( N  = 230;  n  = 115 in each arm) with advanced cancer and depression. Inclusion criteria were a diagnosis of cancer not amenable to cure, a DSM-IV ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition) diagnosis of depressive disorder using the Mini-International Neuropsychiatric Interview, a sufficient understanding of English and eligibility for treatment in an IAPT centre. Exclusion criteria were an estimated survival of < 4 months, being at high risk of suicide and receiving, or having received in the last 2 months, a psychological intervention recommended by NICE for treating depression.
INTERVENTIONS


(1) Up to 12 sessions of manualised individual CBT plus TAU delivered within 16 weeks and (2) TAU.
OUTCOME MEASURES


The primary outcome was the Beck Depression Inventory, version 2 (BDI-II) score at 6, 12, 18 and 24 weeks. Secondary outcomes included scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory, at 12 and 24 weeks.
RESULTS


A total of 80% of treatments (185/230) were analysed: CBT (plus TAU) ( n  = 93) and TAU ( n  = 92) for the BDI-II score at all time points using multilevel modelling. CBT was not clinically effective [treatment effect -0.84, 95% confidence interval (CI) -2.76 to 1.08;  p  = 0.39], nor was there any benefit for other measures. A subgroup analysis of those widowed, divorced or separated showed a significant effect of CBT on the BDI-II (treatment effect -7.21, 95% CI -11.15 to -3.28;  p  < 0.001). Economic analysis revealed that CBT has higher costs but produces more quality-adjusted life-years (QALYs) than TAU. The mean service costs for participants (not including the costs of the interventions) were similar across the two groups. There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks. There was no statistically significant improvement in QALYs at 24 weeks.
LIMITATIONS


Although all participants satisfied a diagnosis of depression, for some, this was of less than moderate severity at baseline, which could have attenuated treatment effects. Only 64% (74/115) took up CBT, comparable to the general uptake through IAPT.
CONCLUSIONS


Cognitive-behavioural therapy (delivered through IAPT) does not achieve any clinical benefit in advanced cancer patients with depression. The benefit of CBT for people widowed, divorced or separated is consistent with other studies. Alternative treatment options for people with advanced cancer warrant evaluation. Screening and referring those widowed, divorced or separated to IAPT for CBT may be beneficial. Whether or not improvements in this subgroup are due to non-specific therapeutic effects needs investigation.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN07622709.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 19. See the NIHR Journals Library website for further project information.",2019,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","['advanced cancer patients with depression', 'people with cancer', 'Recruitment took place in oncology, hospice and primary care settings', 'people with advanced cancer and depression', '115 in each arm) with advanced cancer and depression', 'people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks', 'advanced cancer', 'people with advanced cancer', 'people with advanced cancer warrant evaluation', 'Patients ( N \u2009=\u2009230;  n \u2009']","['psychological intervention recommended by NICE', 'CBT', 'usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU', 'manualised individual CBT plus TAU', 'CBT (plus TAU', 'Cognitive-behavioural therapy (delivered through IAPT', 'Manualised cognitive-behavioural therapy']","['scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory', 'mean service costs', 'EQ-5D median scores', 'clinical effectiveness and cost-effectiveness', 'Beck Depression Inventory, version 2 (BDI-II) score', 'quality of life (QoL']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0303407', 'cui_str': 'In-115 radioisotope'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034380'}]",,0.229638,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Stirling', 'Initials': 'S', 'LastName': 'Moorey', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Trefor', 'Initials': 'T', 'LastName': 'Aspden', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tookman', 'Affiliation': 'Marie Curie Hospice, Royal Free Hampstead NHS Trust, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mannix', 'Affiliation': 'Palliative Care Service, Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gola', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23190']
499,31434605,E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT.,"BACKGROUND


Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.
OBJECTIVE


The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.
DESIGN


A randomised controlled trial comparing e-cigarettes and NRT.
SETTING


Three sites that provide local SSSs.
PARTICIPANTS


The participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.
INTERVENTIONS


The NRT arm ( n  = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm ( n  = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.
MAIN OUTCOME MEASURES


The primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.
RESULTS


The 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58;  p  < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ 2  = 161.4;  p  < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective.
LIMITATIONS


The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.
CONCLUSIONS


Within the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.
FUTURE WORK


The efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN60477608.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).",2019,Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status).,"['886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis', '886 smokers seeking help to quit smoking, aged ≥\u200918 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes', 'Participants lost to follow-up or not providing biochemical validation were included as non-abstainers', 'Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation']","['nicotine replacement therapy within the UK', 'refillable e-cigarettes and nicotine replacement therapy (NRT', 'NRT of their choice (single or combination', 'e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice', 'NRT']","['CO-validated sustained abstinence rates', 'abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health', 'adherence and experienced fewer urges to smoke', '1-year quit rate', 'coughing and phlegm', 'validated quit rates']","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C3661900', 'cui_str': 'Not provided (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus (substance)'}]",886.0,0.0854514,Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""King's Clinical Trials Unit, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Katie Myers', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bisal', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""King's Clinical Trials Unit, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Leicester City Council, Leicester, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Goniewicz', 'Affiliation': 'Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Hayden J', 'Initials': 'HJ', 'LastName': 'McRobbie', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23430']
500,32000099,Who is willing to participate in research? A screening model for an anxiety and depression trial in the epilepsy clinic.,"OBJECTIVE


Anxiety and depression in epilepsy are prevalent, associated with poor outcomes, underrecognized, undertreated, and thus a key area of need for treatment research. The objective of this study was to assess factors associated with research participation among epilepsy clinic patients who screened positive for anxiety or depression. This was accomplished by characterizing clinical and psychiatric factors among patients seen in an epilepsy clinic and evaluating which factors were associated with consent for potential research participation, via a combined clinical and research screening model.
METHODS


In a pragmatic trial of anxiety and depression treatment in epilepsy, individuals with a positive screen for anxiety and/or depression at a routine epilepsy clinic visit were invited to opt-in (via brief electronic consent) to further eligibility assessment for a randomized treatment study. Information on psychiatric symptoms and treatment characteristics were collected for dual clinical care and research screening purposes. Cross-sectional association of demographic, clinical, and psychiatric factors with opting-in to research was analyzed by multiple logistic regression.
RESULTS


Among N = 199 unique adults with a first positive screen for anxiety and/or depression among 786 total screening events, 154 (77.4%) opted-in to further potential research assessment. Higher depression scores and current treatment with an antidepressant were independently associated with opting-in to research (depression odds ratio (OR) = 1.13 per 1-point increase in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) score, p = 0.028, 95% confidence interval (CI): 1.01-1.26; antidepressant OR = 2.37, p = 0.041, CI: 1.04-5.41). Nearly half of the 199 individuals (43.7%) with anxiety and/or depression symptoms were already being treated with an antidepressant, and 46.7% were receiving neither antidepressant therapy nor mental health specialty care. One-quarter (24.1%) reported a past psychiatric hospitalization, yet only half of these individuals were receiving mental health specialty care.
SIGNIFICANCE


Our results demonstrate a high willingness to participate in research using a brief electronic consent approach at a routine clinic visit. Adults with persistent anxiety or depression symptoms despite antidepressant therapy and those with higher depression scores were more willing to consider a randomized treatment study. This has implications for future study design, as individuals already on treatment or those with more severe symptoms are often excluded from traditional research designs. We also found a high burden of psychiatric disease and high prevalence of persistent symptoms despite ongoing antidepressant treatment.",2020,Nearly half of the 199 individuals (43.7%) with anxiety,"['Among N\u202f=\u202f199 unique adults with a first positive screen for anxiety and/or depression among 786 total screening events, 154 (77.4%) opted-in to further potential research assessment', 'epilepsy clinic patients who screened positive for anxiety or depression', 'epilepsy, individuals with a positive screen for anxiety and/or depression at a routine epilepsy clinic visit', '199 individuals (43.7%) with anxiety', 'Adults with persistent anxiety or depression symptoms despite antidepressant therapy and those with higher depression scores']",[],"['past psychiatric hospitalization', 'Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) score', 'Higher depression scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035168'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",[],"[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0539495,Nearly half of the 199 individuals (43.7%) with anxiety,"[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Munger Clary', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: hmungerc@wakehealth.edu.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Croxton', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: croxrd13@alumni.wfu.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Allan', 'Affiliation': 'Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: jallan@wakehealth.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lovato', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: jlovato@wakehealth.edu.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Brenes', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Wake Forest University, Winston-Salem, NC, USA. Electronic address: gbrenes@wakehealth.edu.'}, {'ForeName': 'Beverly M', 'Initials': 'BM', 'LastName': 'Snively', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: bmellen@wakehealth.edu.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'Neuroscience Graduate Program, Wake Forest University, Winston-Salem, NC, USA. Electronic address: miwan@wakehealth.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kimball', 'Affiliation': 'Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Wong', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Cormac A', 'Initials': 'CA', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: odonovan@wakehealth.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Conner', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: kconner@wakehealth.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Jones', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: pduncan@wakehealth.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.106907']
501,30870668,"Poverty, economic strengthening, and mental health among AIDS orphaned children in Uganda: Mediation model in a randomized clinical trial.","Some evidence points to the positive effects of asset accumulation programs on mental health of children living in low-resource contexts. However, no evidence exists as to why and how such impact occurs. Our study aims to understand whether child poverty, child work, and household wealth serve as pathways through which the economic strengthening intervention affects the mental health of AIDS-orphaned children. The study employed a cluster-randomized experimental design with a family-based economic strengthening intervention conducted among 1410 school-going AIDS-orphaned children ages 10 and 16 years old in 48 primary schools in South Western Uganda. To test the hypothesized relationships between the intervention, mediators (household wealth, child poverty, and child's work) and mental health, we ran structural equation models that adjust for clustering of individuals within schools and account for potential correlation among the mediators. We found significant unmediated effect of the intervention on children's mental health at 24 months (B = -0.59; 95% CI: 0.93, -0.25; p < 0.001; β = -0.33). Furthermore, the results suggest that participation in the intervention reduced child poverty at 12 months, which in turn improved latent mental health outcome at 24 months (B = -0.14; 95% CI: -0.29, -0.01; p < 0.06; β = -0.08). In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation. Our findings suggest that anti-poverty programs that aim solely to improve household income may be less advantageous to children's mental health as compared to those that are specifically targeted towards reducing the impact of poverty on children. Further studies using more comprehensive measures of child work and age-appropriate child mental health may shed more light on understanding the link between asset accumulation interventions, child labor and children's mental health.",2019,"In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation.","['1410 school-going AIDS-orphaned children ages 10 and 16 years old in 48 primary schools in South Western Uganda', 'children living in low-resource contexts']",['family-based economic strengthening intervention'],"['child poverty', 'latent mental health outcome', 'Poverty, economic strengthening, and mental health', ""children's mental health"", 'mental health of children']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013557', 'cui_str': 'economics'}]",,0.0620438,"In addition, though not statistically significant at the 0.05 level, at 36 and 48 months, mental health of children in the treatment group improved by 0.13 and 0.16 standard deviation points correspondingly with no evidence of mediation.","[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Karimli', 'Affiliation': 'University of California, Los Angeles (UCLA), Luskin School of Public Affairs, Social Welfare Department, United States. Electronic address: leylakarimli@luskin.ucla.edu.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, George Warren Brown School of Social Work, United States. Electronic address: fms1@wustl.edu.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'University of California, School of Medicine, San Francisco, United States. Electronic address: Torsten.Neilands@ucsf.edu.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Wells', 'Affiliation': 'University of California, Los Angeles (UCLA), Statistical Consulting Group, United States. Electronic address: crwells@ucla.edu.'}, {'ForeName': 'Laura Gauer', 'Initials': 'LG', 'LastName': 'Bermudez', 'Affiliation': 'Columbia University, School of Social Work, United States. Electronic address: lgb2123@columbia.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.003']
502,32147352,Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up.,"INTRODUCTION AND OBJECTIVE


The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up.
MATERIALS AND METHODS


The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed.
RESULTS


The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms.
CONCLUSIONS


In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.",2020,No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates.,"['18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate', '4,276 men (2,415 intervention arm, 1,861 control arm', '180,000 asymptomatic men', '285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001']",['Screening for Prostate Cancer (ERSPC'],"['survival curves', 'colon and rectum', 'mortality rates', 'PCa mortality', 'cancer-specific']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",18612.0,0.0563443,No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Luján Galán', 'Affiliation': 'Unidad de Urología, Hospital Universitario Infanta Cristina, Parla, Madrid, España. Electronic address: mlujang@salud.madrid.org.'}, {'ForeName': 'Á', 'Initials': 'Á', 'LastName': 'Páez Borda', 'Affiliation': 'Servicio de Urología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, España.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Llanes González', 'Affiliation': 'Servicio de Urología, Hospital Universitario de Getafe, Getafe, Madrid, España.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Romero Cajigal', 'Affiliation': 'Servicio de Urología, Hospital Universitario de Getafe, Getafe, Madrid, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berenguer Sánchez', 'Affiliation': 'European Randomized Study of Screening for Prostate Cancer, Rama española.'}]",Actas urologicas espanolas,['10.1016/j.acuro.2020.01.005']
503,31852579,3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.,"BACKGROUND


Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy.
OBJECTIVES


To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations.
DESIGN


An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial.
SETTING


A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand.
PARTICIPANTS


Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum.
INTERVENTIONS


The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months.
MAIN OUTCOME MEASURES


The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient.
RESULTS


Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis,  n  = 3035; 6-month analysis,  n  = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114;  p -value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years ( p  < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
CONCLUSIONS


The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).",2019,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
","['patients with high-risk stage II and III colorectal cancer', 'Adults aged ≥\u200918 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum', 'A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand', 'patients with high-risk stage II or III colorectal cancer', '6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis,  n \u2009=\u20093035; 6-month analysis,  n \u2009=\u20093030']","['oxaliplatin-containing adjuvant chemotherapy', 'Oxaliplatin and fluoropyrimidine chemotherapy', 'oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine', 'adjuvant chemotherapy']","['3-year disease-free survival rate', 'cumulative toxicity', 'disease-free survival', 'sensory neuropathy', 'Cost-effectiveness', 'toxicity, health-related quality of life and cost-effectiveness', 'Quality-of-life scores', 'disease-free survival and overall survival', 'rate of neuropathy', 'Overall survival, adverse events, neuropathy and health-related quality of life', 'safety profile and cost less', 'incremental cost comparisons and quality-adjusted life-year gains', 'Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3257803', 'cui_str': 'Watery eye (finding)'}]",244.0,0.236886,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient.
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Robles-Zurita', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Briggs', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hollander', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Australasian Gastro-Intestinal Trials Group, Camperdown, NSW, Australia.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Harkin', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Allan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McQueen', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Waterston', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Medley', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Cornwall, UK.'}, {'ForeName': 'Sharadah', 'Initials': 'S', 'LastName': 'Essapen', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.""}, {'ForeName': 'Amandeep S', 'Initials': 'AS', 'LastName': 'Dhadda', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Raouf', 'Affiliation': 'Barking Havering and Redbridge University Hospital NHS Trust, Barking, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rees', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rene K', 'Initials': 'RK', 'LastName': 'Olesen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Oncology, University College London, London, UK.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Azzabi', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Brighton and Sussex University Hospital Trust, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Department of Oncology, Oxford University Hospitals Foundation Trust, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gollins', 'Affiliation': 'North Wales Cancer Treatment Centre, Rhyl, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23640']
504,32012841,Influence of a Water-Based Exercise Program in the Rate of Spontaneous Birth: A Randomized Clinical Trial.,"Introduction:  Many women change their lifestyles and habits when they become pregnant, to avoid potentially harmful effects to themselves and their babies. This is especially so with respect to physical exercise, which is often greatly reduced due to ignorance of the benefits it provides during pregnancy.  Aim:  To evaluate the prevalence of spontaneous birth among women who participated in a water-based physical exercise program. Methods: A randomized clinical trial was conducted with a sample of 129 pregnant women (Control Group, CG = 64; Exercise Group, EG = 65). A physical exercise protocol, specifically designed for pregnant women, was created and applied. Those in the EG performed 60 min exercise sessions, three times per week for 17 weeks. The participants in the CG received routine check-ups and advice throughout their pregnancy.  Findings:  The women in the EG presented better results for the onset of spontaneous birth (OR = 2.060 (0.980-4.332)) and for neonate Apgar score of 10 at five minutes (OR = 8.53 (3.60-20.17)). Those who had normal weight at the start of pregnancy achieved better results for spontaneous delivery (OR = 2.099 (1.017-4.335)) than those with overweight/obesity. The rate of caesarean delivery was higher in the women with overweight/obesity (OR = 3.570 ((1.226-10.397)) than in those with normal weight.  Conclusions:  In our study, the women who followed the water-based exercise program gained less weight during pregnancy, which facilitated a better rate of spontaneous, non-instrumental childbirth, together with a better Apgar test score at five minutes.",2020,Those who had normal weight at the start of pregnancy achieved better results for spontaneous delivery (OR = 2.099 (1.017-4.335)) than those with overweight/obesity.,"['129 pregnant women (Control Group, CG = 64; Exercise Group, EG = 65', 'pregnant women', 'women who participated in a water-based physical exercise program']",['Water-Based Exercise Program'],"['spontaneous delivery', 'onset of spontaneous birth', 'rate of caesarean delivery', 'Rate of Spontaneous Birth', 'neonate Apgar score']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",129.0,0.0970144,Those who had normal weight at the start of pregnancy achieved better results for spontaneous delivery (OR = 2.099 (1.017-4.335)) than those with overweight/obesity.,"[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rodríguez-Blanque', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, San Cecilio Clinical Hospital, School of Nursing, Faculty of Health Sciences, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Aguilar-Cordero', 'Affiliation': 'Research Group CTS 367, Andalusia Research Plan, Junta de Andalucía, School of Nursing, School of Health Sciences, University of Granada, San Cecilio Clinical Hospital, 18071 Granada, Spain.'}, {'ForeName': 'Ana Eugenia', 'Initials': 'AE', 'LastName': 'Marín-Jiménez', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, Quantitative methods for the economics and enterprise, Faculty of Economics and Business Sciences, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Núñez-Negrillo', 'Affiliation': 'Research Group CTS367, Andalusia Research Plan, Junta de Andalucía, Faculty of Health Sciences, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Antonio Manuel', 'Initials': 'AM', 'LastName': 'Sánchez-López', 'Affiliation': 'Research Group CTS367, Department of Human Motricity and Sports Performance, Faculty of Education Science, University of Sevilla, 41013 Sevilla, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sánchez-García', 'Affiliation': 'Research Group CTS1068, Andalusia Research Plan, Junta de Andalucía, School of Nursing, Faculty of Health Sciences, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17030795']
505,31979255,Effects of a Fundamental Motor Skill-Based Afterschool Program on Children's Physical and Cognitive Health Outcomes.,"Globally, more than half of school-aged children do not engage in the recommended 60 minutes of daily moderate to vigorous physical activity (MVPA). Given that developing sufficient fundamental motor skills (FMS) competence during early elementary school years is important for a child's physical and cognitive development, the purpose of this study was to examine the effects of an 8-week FMS-based afterschool program on physical and cognitive health outcomes among elementary children. Participants were 31 K-2 students (19 girls, 12 boys;  M age = 6.65 ± 0.98) from three public elementary schools in the southwestern United States who were assigned to the intervention group (FMS-based afterschool program; n = 20) or the control group (traditional afterschool program; n = 11). A 2 × 2 repeated measures MANOVA showed significant changes in FMS competence and MVPA between the intervention and the control group over time. However, no significant changes were found in cognitive functioning. The 8-week FMS-based afterschool program showed significant improvements in FMS competence and MVPA, compared to a traditional afterschool program. This finding suggests that structured FMS-focused strategies (e.g., fun games and goal setting) can be a critical component when implementing a physical activity program to enhance children's motor skills and physical activity behavior.",2020,"The 8-week FMS-based afterschool program showed significant improvements in FMS competence and MVPA, compared to a traditional afterschool program.","['Participants were 31 K-2 students (19 girls, 12 boys;  M age = 6.65 ± 0.98) from three public elementary schools in the southwestern United States who were assigned to the', 'elementary children']","['intervention group (FMS-based afterschool program; n = 20) or the control group (traditional afterschool program', 'FMS-based afterschool program', 'Fundamental Motor Skill-Based Afterschool Program']","['cognitive functioning', ""Children's Physical and Cognitive Health Outcomes"", 'FMS competence and MVPA']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0123,"The 8-week FMS-based afterschool program showed significant improvements in FMS competence and MVPA, compared to a traditional afterschool program.","[{'ForeName': 'Joonyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Tsz Lun Alan', 'Initials': 'TLA', 'LastName': 'Chu', 'Affiliation': 'Department of Psychology, University of Wisconsin-Green Bay, Green Bay, WI 54311, USA.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Kinesiology, The University of Texas at Arlington, Arlington, TX 76019, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Department of Educational Psychology, University of North Texas, Denton, TX 76203, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17030733']
506,30511291,Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial.,"BACKGROUND


Self-management of health is important for improving health outcomes among primary care patients with chronic disease. Anxiety and depressive disorders are common and interfere with self-regulation, which is required for disease self-management. An insurance-reimbursable mindfulness intervention integrated within primary care may be effective for enhancing chronic disease self-management behaviors among primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders compared with the increasingly standard practice of referring patients to outside mindfulness resources.
OBJECTIVE


Mindfulness Training for Primary Care (MTPC) is an 8-week, referral-based, insurance-reimbursable program integrated into safety-net health system patient-centered medical homes. We hypothesized that MTPC would be more effective for catalyzing chronic disease self-management action plan initiation within 2 weeks, versus a low-dose comparator (LDC) consisting of a 60-min mindfulness introduction, referral to community and digital resources, and addition to a 6-month waitlist for MTPC.
PARTICIPANTS


Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12 months. All participants had a DSM-V diagnosis.
DESIGN AND INTERVENTIONS


Participants (N = 136) were randomized in a 2:1 allocation to MTPC (n = 92) or LDC (n = 44) in a randomized controlled comparative effectiveness trial. MTPC incorporates mindfulness, self-compassion, and mindfulness-oriented behavior change skills and is delivered as insurance-reimbursable visits within primary care. Participants took part in a chronic disease self-management action planning protocol at week 7.
MAIN MEASURES


Level of self-reported action plan initiation on the action plan initiation survey by week 9.
KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
CONCLUSIONS


An 8-week dose of mindfulness training is more effective than a low-dose mindfulness comparator in facilitating chronic disease self-management behavior change among primary care patients.",2019,"KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
","['Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12\xa0months', 'primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders', 'Participants (N\u2009=\u2009136', 'Participants took part in a chronic disease self-management action planning protocol at week 7', 'primary care patients', 'Primary Care Patients', 'All participants had a DSM-V diagnosis', 'primary care patients with chronic disease']","['mindfulness training', 'LDC', 'Mindfulness Training for Primary Care (MTPC', 'MTPC', 'Mindfulness Training']","['Level of self-reported action plan initiation on the action plan initiation survey', 'self-management action plan initiation', 'Anxiety and depressive disorders', 'mindfulness, self-compassion, and mindfulness-oriented behavior change skills']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0001546', 'cui_str': 'Reactive Disorders'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",465.0,0.0567421,"KEY RESULTS


Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025).
","[{'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Gawande', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'My Ngoc', 'Initials': 'MN', 'LastName': 'To', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pine', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Griswold', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Creedon', 'Affiliation': 'The Heller School for Social Policy and Management, Brandeis University, Waltham, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brunel', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lozada', 'Affiliation': 'Cambridge Health Alliance, Cambridge, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Loucks', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, USA.'}, {'ForeName': 'Zev', 'Initials': 'Z', 'LastName': 'Schuman-Olivier', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, USA. zschuman@cha.harvard.edu.'}]",Journal of general internal medicine,['10.1007/s11606-018-4739-5']
507,30644774,Randomized Effectiveness Trial of the New Beginnings Program for Divorced Families with Children and Adolescents.,"This study presents findings from a randomized effectiveness trial of the New Beginnings Program (NBP), which has demonstrated efficacy in 2 prior randomized efficacy trials. Family courts in 4 counties facilitated recruitment of divorcing and separating parents, and providers in community agencies delivered the program. Participants were 830 parents of children ages 3-18 who were randomized to receive either the 10-session NBP or an active 2-session comparison condition in which parents learned about the same parenting skills but did not complete home practice of these skills. Parents were ethnically diverse (59.4% non-Hispanic White, 31.4% Hispanic, 9.2% other race or ethnicity). Multiple rater assessments of parenting, interparental conflict, and child mental health problems were conducted at pretest, posttest, and 10-month follow-up. The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months. Many of these moderated effects showed positive benefits for non-Hispanic White families but not for Hispanic families. The findings indicate support for the effectiveness of the NBP when delivered by community-based agencies but also indicate the need for further adaptations to make the program effective for Hispanic parents.",2020,The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months.,"['Divorced Families with Children and Adolescents', 'Hispanic parents', 'Parents were ethnically diverse (59.4% non-Hispanic White, 31.4% Hispanic, 9.2% other race or ethnicity', 'Participants were 830 parents of children ages 3-18 who']","['10-session NBP or an active 2-session comparison condition in which parents learned about the same parenting skills but did not complete home practice of these skills', 'New Beginnings Program', 'NBP', 'New Beginnings Program (NBP']","['child mental health problems', 'Multiple rater assessments of parenting, interparental conflict, and child mental health problems']","[{'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C4517889', 'cui_str': '830 (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}]",830.0,0.0488218,The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months.,"[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Sandler', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Wolchik', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mazza', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gunn', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1540008']
508,32147280,Manual Versus Digital Aspiration for First-Line Treatment of Primary Spontaneous Pneumothorax. The AMVADI Study: A Randomized Clinical Trial.,"INTRODUCTION


The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied. The objective of this research was to compare digital with manual aspiration in a randomized clinical trial.
METHODS


We designed a blinded parallel-group randomized clinical trial with a 1:1 allocation ratio. The clinical trial is reported in line with the guidelines of the CONSORT group. The primary outcome variables were immediate success and hospital admission, while the secondary outcome measures were relapse, re-admission and need for surgery, and length of hospital stay. A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration.
RESULTS


A total of 67 patients were included in the study (n=36, control group; n=31, experimental group) with no losses to follow-up. In both groups, 58% of procedures were immediately successful, avoiding hospital admission. No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay. Overall, 80% of clinicians who performed aspiration preferred the digital system, and this preference rose to 100% among clinicians who performed more than 5procedures a year.
CONCLUSIONS


Both manual and digital aspiration provide good immediate results avoiding hospital admission, while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax.",2020,"No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay.","['primary spontaneous pneumothorax', 'Primary Spontaneous Pneumothorax', 'A total of 67 patients were included in the study (n=36, control group; n=31, experimental group) with no losses to follow-up']","['Manual Versus Digital Aspiration', 'needle aspiration']","['relapse, re-admission and need for surgery, and length of hospital stay', 'immediate success and hospital admission', 'immediately successful, avoiding hospital admission', 'rates of relapse, re-admission, need for surgery, or length of hospital stay']","[{'cui': 'C0149781', 'cui_str': 'Primary Spontaneous Pneumothorax'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",67.0,0.127999,"No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay.","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Aguinagalde', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Zabaleta', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España. Electronic address: jon.zabaletajimenez@osakidetza.eus.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Fernández-Monge', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Iker', 'Initials': 'I', 'LastName': 'Lopez', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Izquierdo', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Redin', 'Affiliation': 'Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'López', 'Affiliation': 'Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Emparanza', 'Affiliation': 'Servicio de Epidemiología Clínica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.01.016']
509,32150255,"Measuring Opioid Withdrawal in a Phase 3 Study of a New Analgesic, NKTR-181 (Oxycodegol), in Patients with Moderate to Severe Chronic Low Back Pain.","OBJECTIVE


To evaluate the SUMMIT-07 trial opioid withdrawal results of NKTR-181 (oxycodegol), a new molecular entity mu-opioid receptor agonist.
DESIGN


Phase 3, enriched-enrollment, double-blind, randomized-withdrawal study in patients with chronic low back pain (CLBP).
SETTING


Conducted in the United States at multiple sites.
METHODS


SUMMIT-07 was comprised of five periods: screening; NKTR-181 open-label titration (100 to 400 mg twice daily); 12-week randomized, double-blind study drug (NKTR-181 or placebo); one-week study drug taper; and two-week safety follow-up. Permitted rescue medication included hydrocodone 5 mg/acetaminophen 300 mg (two tablets daily) for two weeks after randomization, then acetaminophen 1.0 gm daily for the remainder of the trial. Signs and symptoms of drug withdrawal were evaluated using the Clinical Opiate Withdrawal Scale (COWS); Subjective Opiate Withdrawal Scale (SOWS); Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS); and withdrawal-related adverse events.
RESULTS


Of 1,190 patients entering titration, one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181. Of 610 patients randomized (N = 309, NKTR-181; N = 301, placebo), no COWS scores indicating withdrawal at a moderate level or greater (i.e., score ≥13) were observed at any time point. At day 8 after randomization, week 12, and the end of tapering, COWS scores indicating mild withdrawal (<13) were observed in seven (2.4%), one (0.4%), and one (0.5%) placebo patients, respectively, and three (1.0%), one (0.4%), and five (2.3%) NKTR-181 patients, respectively. Mean SOWS scores in both arms were ≤2.8 of 64 possible points at all time points. During the randomized period, of 35 events identified by MADDERS, adjudicators identified 20 possible ""withdrawal"" events (9 [2.9%] NKTR-181 and 11 [3.7%] placebo).
CONCLUSIONS


NKTR-181 exhibited a low rate and severity of opioid withdrawal in SUMMIT-07 patients with CLBP.",2020,", one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181.","['Patients with Moderate to Severe Chronic Low Back Pain', 'SUMMIT-07 was comprised of five periods: screening', 'patients with chronic low back pain (CLBP', '1,190 patients entering titration', 'Conducted in the United States at multiple sites', 'SUMMIT-07 patients with CLBP']","['NKTR-181 (oxycodegol', 'placebo', 'hydrocodone 5', 'NKTR-181 open-label titration', 'acetaminophen', 'double-blind study drug (NKTR-181 or placebo']","['Clinical Opiate Withdrawal Scale (COWS); Subjective Opiate Withdrawal Scale (SOWS); Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS); and withdrawal-related adverse events', 'Mean SOWS scores', 'Signs and symptoms of drug withdrawal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4547855', 'cui_str': 'NKTR-181'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C3472219', 'cui_str': 'Clinical opiate withdrawal scale (assessment scale)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0222045'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",1190.0,0.376243,", one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181.","[{'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'Pinney Associates, Bethesda, Maryland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': 'Englewood Hospital and Medical Center, Englewood, New Jersey.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute and The Center for Clinical Research, Winston-Salem, North Carolina.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Doberstein', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Fonzo', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Schnoll', 'Affiliation': 'Pinney Associates, Bethesda, Maryland.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz326']
510,32149378,Effectiveness of Sexual Skills Training Program on Promoting Sexual Intimacy and Satisfaction in Women in Tehran (Iran): A randomized clinical Trial Study.,"PURPOSE


The purpose of this study was to evaluate the effectiveness of sexual skills training on intimacy and sexual satisfaction in women.
MATERIALS AND METHODS


This is a randomized clinical trial study with parallel design. 70 participants (n=35 each) were divided into 2 groups as control and intervention groups. Women were selected in multiple steps. Some requirements for inclusion criteria were: obtaining a standard score of marital satisfaction, women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian. Some factors for exclusion criteria were: women's absence in more than 2 training classes, pregnancy during the study. Data collection was conducted through four questionnaires: demographic characteristics, marital satisfaction, sexual satisfaction and sexual intimacy. Validity and reliability of the questionnaires were measured through content validity and Chronbach Alpha, respectively. The data extracted from the questionnaires were analyzed using SPSS software, version 18.0. For data analysis, descriptive statistics, independent t-test, paired t-test, or non-parametric tests were applied. Significance level of the test was considered p<0.05.
RESULTS


The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
CONCLUSION


In total, the training lessons gave positive views to participants towards their sexual issues so that they formed realistic and positive sexual expectations, healthier sexual behaviors and self-expressions and consequently, gained more sexual knowledge that made them able to experience more intimacy and satisfaction in sexual relationships with their spouses.",2020,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","['women', 'Women in Tehran (Iran', 'women with a record of 6-24 months of marital life, not having a record of abortion, stillborn birth and not being in pregnancy period, not having a child, not suffering from an acute or chronic and serious disease, not having a surgery on pelvic organs, minimum elementary education of the couples and being Iranian', '70 participants (n=35 each']","['Sexual Skills Training Program', 'sexual skills training']","['intimacy and sexual satisfaction', 'sexual satisfaction (p<0.001) and sexual intimacy', 'Sexual Intimacy and Satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",70.0,0.054477,"The results showed that sexual skills training leads to promotion of sexual satisfaction (p<0.001) and sexual intimacy (p<0.001) among the women in intervention group and the impact of training was stable two months after completion of intervention.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Salehi Moghaddam', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fatemehsalehi28@yahoo.com.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'TorkZahrani', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Moslemi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Arak University of Medical Sciences ,Arak, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Azin', 'Affiliation': 'MD, MPH, FECSM, Reproductive Biotechnology Research Center, Avicenna Research Institute, \nACECR, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Ozgoli', 'Affiliation': 'Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Joulaee Rad', 'Affiliation': 'Student Research committee, Department of Midwifery and Reproductive Health, school of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4690']
511,31704458,Accuracy of Patient Reported Stone Passage for Patients With Acute Renal Colic Treated in the Emergency Department.,"OBJECTIVE


To study patients who initially presented to the Emergency Department with acute renal colic to determine if patient-reported stone passage detects stone expulsion as accurately as follow-up computed tomography (CT) scan.
METHODS


This is a secondary analysis of a multi-center prospective trial of patients diagnosed by a CT scan with a symptomatic ureteral stone <9 mm in diameter. Patient-reported stone passage, defined as capture or visualization of the stone, was compared to CT scan-confirmed passage performed 29-36 days after initial presentation.
RESULTS


Four-hundred-three patients were randomized in the original study and 21 were excluded from this analysis because they were lost to follow-up or received ureteroscopic surgery. Of the 382 remaining evaluable patients, 237 (62.0%) underwent a follow-up CT scan. The mean (standard deviation) diameter of the symptomatic kidney stone was 3.8 mm (1.4). In those who reported stone passage, 93.8% (91/97) demonstrated passage of the symptomatic ureteral stone on follow-up CT. Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
CONCLUSIONS


For patients who report capture or visualization of a ureteral stone, a follow-up CT scan may not be needed to verify stone passage. For patients who do not capture their stone or visualize stone passage, imaging should be considered to confirm passage.",2020,"Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
","['patients with acute renal colic treated in the emergency department', 'patients diagnosed by a CT scan with a symptomatic ureteral stone <9mm in diameter', 'patients who initially presented to the Emergency Department with acute renal colic to determine if patient-reported stone passage detects stone expulsion as accurately as follow-up computed tomography (CT) scan', '403 patients were randomized in the original study and 21 were excluded from this analysis because they were lost to follow-up or received']",['ureteroscopic surgery'],"['passage of the symptomatic ureteral stone', 'mean (standard deviation) diameter of the symptomatic kidney stone', 'passage of their stone']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0401343', 'cui_str': 'Surgical Procedures, Ureteroscopic'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",403.0,0.0284206,"Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
","[{'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Meltzer', 'Affiliation': 'Department of Emergency Medicine, George Washington University School of Medicine & Health Sciences, Washington, DC. Electronic address: ameltzer@mfa.gwu.edu.'}, {'ForeName': 'Pamela Katzen', 'Initials': 'PK', 'LastName': 'Burrows', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kurz', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mufarrij', 'Affiliation': 'Department of Urology, George Washington University School of Medicine & Health Sciences, Washington, DC.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Wolfson', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'MacPherson', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hubosky', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Montano', 'Affiliation': 'Department of Emergency Medicine, George Washington University School of Medicine & Health Sciences, Washington, DC.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Jackman', 'Affiliation': 'Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Urology,['10.1016/j.urology.2019.10.010']
512,31532358,Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT.,"BACKGROUND


Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy.
OBJECTIVE


To evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV.
DESIGN


Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis.
SETTING


A total of 51 critical care units across the UK.
PARTICIPANTS


Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT.
INTERVENTIONS


Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient's condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient's condition.
MAIN OUTCOME MEASURES


The primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life.
RESULTS


A total of 364 patients (invasive weaning,  n  = 182; non-invasive weaning,  n  = 182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39;  p  = 0.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2-11 days) vs. non-invasive weaning 1 day (IQR 0-7 days); adjusted mean difference -3.1 days, 95% CI -5.75 to -0.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00;  p  = 0.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of £20,000 per quality-adjusted life-year.
CONCLUSIONS


A protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections.
FUTURE WORK


In patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV?
TRIAL REGISTRATION


Current Controlled Trials ISRCTN15635197.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.",2019,"There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39;  p  = ","['A total of 51 critical care units across the UK', 'Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT', 'patients from IMV', 'adults in intensive care', '364 patients (invasive weaning,  n \u2009=\u2009182; non-invasive weaning,  n \u2009=\u2009182']","['non-invasive ventilation (NIV', 'Control group (invasive weaning): patients continued to receive IMV with daily SBTs', 'Invasive mechanical ventilation (IMV', 'invasive weaning from mechanical ventilation']","['cost-effective', 'mortality', 'time to liberation from ventilation', 'IMV days [invasive weaning', 'mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life', 'adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV', 'clinical effectiveness and cost-effectiveness', 'days requiring IMV']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085559'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",364.0,0.229172,"There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39;  p  = ","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gao-Smith', 'Affiliation': 'Critical Care Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Snelson', 'Affiliation': 'Department of Critical Care, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, London, UK.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Camporota', 'Affiliation': ""Guy's and St Thomas' Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Varley', 'Affiliation': ""Department of Critical Care, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK.""}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Carle', 'Affiliation': 'Department of Critical Care, Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'Elankumaran', 'Initials': 'E', 'LastName': 'Paramasivam', 'Affiliation': 'Department of Critical Care, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Hoddell', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Paeztron', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sukhdeep', 'Initials': 'S', 'LastName': 'Dosanjh', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blair', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Centre for Experimental Medicine Institute for Health Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Anaesthesia, Critical Care and Pain Medicine, Division of Health Sciences, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Centre for Experimental Medicine Institute for Health Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Maredza', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23480']
513,31456562,Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.,"BACKGROUND


A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role.
OBJECTIVE


The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session.
DESIGN


This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies.
SETTING


This trial was based in 21 NHS physiotherapy departments.
PARTICIPANTS


The participants were people with symptomatic OVF.
INTERVENTIONS


Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT).
MAIN OUTCOME MEASURES


Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version.
RESULTS


A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference -0.23 points, 95% confidence interval (CI) -3.20 to 1.59 points;  p  = 1.000; and TLS test, difference 5.77 seconds, 95% CI -4.85 to 20.46 seconds;  p  = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI -1.76 to 2.93 points;  p  = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds;  p  = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events.
CONCLUSIONS


This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN49117867.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.",2019,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","['25,000 people in the UK have osteoporotic vertebral fracture (OVF', 'The participants were people with symptomatic OVF', '21 NHS physiotherapy departments', 'people with OVF compared with a single physiotherapy session', 'participants aged <\u200970 years', 'participants with OVFs', '613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years', '615 participants were enrolled, with 216, 203 and 196 randomised by a']","['manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT', 'Exercise therapy', 'Exercise or manual physiotherapy', 'computer-generated program to exercise therapy, manual therapy and a SSPT', 'manual therapy nor exercise therapy']","['confidence interval (CI', 'quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test', 'thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0034380'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",615.0,0.18653,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Minns Lowe', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Muhammad K', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Noufaily', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23440']
514,31321763,Dexmedetomidine vs propofol as sedation for implantation of neurostimulators: A single-center single-blinded randomized controlled trial.,"BACKGROUND


During the lead implantation of most spinal cord neurostimulators, the patient has to be comfortable and without pain. However, the patient is expected to provide feedback during electrical mapping. Titrating sedatives and analgesics for this double goal can be challenging. In comparison with our standard sedative agent propofol, the pharmacological profile of dexmedetomidine is more conducive to produce arousable sedation. The latter, however, is associated with hemodynamic side effects. We investigated whether dexmedetomidine is preferable over propofol during neurostimulator implantation.
METHODS


This single-center single-blinded randomized controlled trial included 72 patients with an indication for a neurostimulator, randomized to sedation with either propofol (0.5 mg/kg for 10 minutes, followed by 2.0 mg/kg/h) or dexmedetomidine (1 μg/kg for 10 minutes, followed by 0.6 μg/kg/h). The primary outcome was patient satisfaction with the sedation. The secondary outcomes were patient's and operator's comfort, number of titration adjustments, standard intraoperative hemodynamic and respiratory parameters and side effects.
RESULTS


Data of 69 patients (dexmedetomidine n = 35; propofol n = 34) were analyzed. Those receiving dexmedetomidine were more satisfied with the sedation than those receiving propofol; i.e. with sedation delivery (median 100.0 vs 83.3, P < .01), procedural recall (median 95.8 vs 83.3, P = .03), and sedation side effects (median 90.0 vs 83.3, P = .01). Fewer changes in the dexmedetomidine titration were necessary to maintain arousable sedation. Over time, mean arterial pressure and heart rate were significantly lower in the dexmedetomidine group. Hemodynamic side effects were comparable across groups.
CONCLUSIONS


Dexmedetomidine sedation resulted in higher patient satisfaction and allowed for better arousable sedation than sedation with propofol. Although differences in hemodynamic parameters were found between the groups, these differences were not regarded as clinically relevant.",2019,"< .01), procedural recall (median 95.8 vs 83.3, P = .03), and sedation side effects (median 90.0 vs 83.3, P = .01).","['69 patients (dexmedetomidine n\xa0=\xa035; propofol n\xa0=\xa034', '72 patients with an indication for a neurostimulator, randomized to sedation with either']","['Dexmedetomidine', 'dexmedetomidine', 'propofol', 'Dexmedetomidine sedation']","['procedural recall', 'hemodynamic parameters', 'patient satisfaction', 'patient satisfaction with the sedation', 'mean arterial pressure and heart rate', ""patient's and operator's comfort, number of titration adjustments, standard intraoperative hemodynamic and respiratory parameters and side effects"", 'sedation delivery', 'sedation side effects', 'Hemodynamic side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator, device (physical object)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",72.0,0.326701,"< .01), procedural recall (median 95.8 vs 83.3, P = .03), and sedation side effects (median 90.0 vs 83.3, P = .01).","[{'ForeName': 'Feline F J A', 'Initials': 'FFJA', 'LastName': 'Ter Bruggen', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ceuppens', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Leliveld', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Dirk L', 'Initials': 'DL', 'LastName': 'Stronks', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank J P M', 'Initials': 'FJPM', 'LastName': 'Huygen', 'Affiliation': 'Department of Anesthesiology, Center for Pain Medicine, Erasmus MC, Rotterdam, the Netherlands.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13452']
515,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10  A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2']
516,31254451,Racial Differences in Performance-Based Function and Potential Explanatory Factors Among Individuals With Knee Osteoarthritis.,"OBJECTIVE


In individuals with knee osteoarthritis (OA), self-reported physical function is poorer in African Americans than in whites, but whether this difference holds true for objective assessments is unclear. The purpose of this study was to examine racial differences in performance-based physical function as well as potential underlying factors contributing to these racial differences.
METHODS


Participants with knee OA from a randomized controlled trial completed the 2-minute step test (2MST), timed-up-and-go (TUG), and 30-second chair stand (30s-CST) at baseline. Race differences in performance-based function were assessed by logistic regression. Separate models were adjusted for sets of demographic, socioeconomic, psychological health, and physical health variables.
RESULTS


In individuals with knee OA (n = 322; 72% women, 22% African American, mean ± SD age 66 ± 11 years, mean ± SD body mass index 31 ± 8 kg/m 2  ), African Americans (versus whites) had greater unadjusted odds of poorer function (30s-CST odds ratio [OR] 2.79 [95% confidence interval (95% CI) 1.65-4.72], 2MST OR 2.37 [95% CI 1.40-4.03], and TUG OR 3.71 [95% CI 2.16-6.36]). Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or nonsignificant when adjusted for physical health and socioeconomic covariates.
CONCLUSION


African American adults with knee OA had poorer unadjusted performance-based function than whites. Physical health and socioeconomic characteristics diminished these differences, emphasizing the fact that these factors may be important to consider in mitigating racial disparities in function.",2020,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","['Participants with knee OA', 'persons with knee OA (n=322; women: 72%, Black: 22%, age=66±11 years, BMI=31±8 kg/m 2  ), Blacks (vs. Whites) had greater unadjusted odds of poorer function (30s-CST: OR [95% CI] = 2.79 [1.65-4.72', 'people with knee osteoarthritis (OA', 'individuals with knee osteoarthritis']","['2MST', '2-minute step tests (2MST), timed-up-and-go (TUG), and 30-second chair stands']",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",[],322.0,0.120359,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","[{'ForeName': 'Portia P E', 'Initials': 'PPE', 'LastName': 'Flowers', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Golightly', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Comprehensive Physical Therapy Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jyotsna J', 'Initials': 'JJ', 'LastName': 'Gupta', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Goode', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Corsi', 'Affiliation': 'Northeastern Ohio Medical University, Rootstown, Ohio.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'University of North Carolina at Chapel Hill and Durham VA Medical Center, Durham, North Carolina.'}]",Arthritis care & research,['10.1002/acr.24018']
517,30629306,The impact of time after radiation treatment on dysphagia in patients with head and neck cancer enrolled in a swallowing therapy program.,"BACKGROUND


Swallowing dysfunction after radiotherapy (RT) for head and neck cancer can be devastating. A randomized control trial compared swallow exercises versus exercise plus neuromuscular electrical stimulation therapy and found no overall difference in outcomes.
METHODS


Quality of life (QOL), diet, and swallowing variables collected at discrete intervals on 117 patients were reanalyzed to test the hypothesis that shorter time between the completion of radiotherapy and beginning of the swallowing therapy program yielded improved outcomes.
RESULTS


At baseline, subjects < 1 year post radiation had significantly better function than subjects >2 years post RT in several measures. Over the therapy program, the early group showed significant improvement in diet and QOL. Swallowing physiologic variables showed no difference between groups.
CONCLUSION


Beginning a swallowing therapy program within 1 year of completion of radiotherapy demonstrates more consistent improvement in QOL and diet performance compared to later periods.",2019,"At baseline, subjects < 1 year post radiation had significantly better function than subjects >2 years post RT in several measures.","['117 patients', 'patients with head and neck cancer enrolled in a swallowing therapy program']","['swallow exercises versus exercise plus neuromuscular electrical stimulation therapy', 'radiotherapy (RT']","['QOL and diet performance', 'dysphagia', 'Swallowing physiologic variables', 'diet and QOL', 'Quality of life (QOL), diet, and swallowing variables']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0589274', 'cui_str': 'Swallowing promotion therapy (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0034380'}]",117.0,0.0240376,"At baseline, subjects < 1 year post radiation had significantly better function than subjects >2 years post RT in several measures.","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Van Daele', 'Affiliation': 'Professor - Otolaryngology, University of Iowa.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Langmore', 'Affiliation': 'Professor - Otolaryngology, Boston University Medical Center.'}, {'ForeName': 'Gintas P', 'Initials': 'GP', 'LastName': 'Krisciunas', 'Affiliation': 'Research Scientist - Otolaryngology, Boston University Medical Center.'}, {'ForeName': 'Cathy L', 'Initials': 'CL', 'LastName': 'Lazarus', 'Affiliation': 'Associate Professor - Otolaryngology, Mount Sinai Health System.'}, {'ForeName': 'Barbara R', 'Initials': 'BR', 'LastName': 'Pauloski', 'Affiliation': 'Associate Professor - Communication Sciences and Disorders, University of Wisconsin Milwaukee.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'McCulloch', 'Affiliation': 'Professor - Otolaryngology, University of Wisconsin Madison.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Gramigna', 'Affiliation': 'Lead Speech Pathologist, VA Boston Healthcare System.'}, {'ForeName': 'Barbara P', 'Initials': 'BP', 'LastName': 'Messing', 'Affiliation': 'Speech Language Pathologist, Johns Hopkins Voice Center.'}, {'ForeName': 'Cynthia W', 'Initials': 'CW', 'LastName': 'Wagner', 'Affiliation': 'Clinical Services Manager, Beth Israel Deaconess Medical Center.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mott', 'Affiliation': 'Statistician - Holden Comprehensive Cancer Center, University of Iowa.'}]",Head & neck,['10.1002/hed.25344']
518,31047905,Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).,"BACKGROUND


Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies).
OBJECTIVE


To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included.
DESIGN, SETTING, AND PARTICIPANTS


A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments.
INTERVENTION


Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient.
RESULTS AND LIMITATIONS


Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure.
CONCLUSIONS


Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function.
PATIENT SUMMARY


We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.",2019,"Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms.","['men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery', '820 men (≥18\u2009yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments', 'Men undergoing UDS testing expressed high satisfaction with the procedure', 'Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms']","['Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm']","['Overall mean IPSS and quality of life scores', 'International Prostate Symptom Score (IPSS', 'symptom questionnaires, bladder diaries, flow rate tests, and urodynamics', 'incontinence, nocturia, and erectile dysfunction', 'outcome measures (PROMs), and UDS findings', 'daytime frequency and voiding symptoms', 'Storage LUTS, notably nocturia, and impaired sexual function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0042078', 'cui_str': 'Urology Department, Hospital'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}]",820.0,0.17348,"Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Cathryn M A', 'Initials': 'CMA', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': ""University of Exeter Medical School, St. Luke's Campus, Exeter, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Taylor', 'Affiliation': 'University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Belal', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Davies', 'Affiliation': 'Salisbury NHS Foundation Trust, Salisbury District Hospital, Salisbury, Wiltshire, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Dickinson', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Foley', 'Affiliation': 'East and North Hertfordshire NHS Trust, Urology Department, Ashwell Block, Lister Hospital, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Foley', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, Berkshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fulford', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Mohsen M', 'Initials': 'MM', 'LastName': 'Gammal', 'Affiliation': 'Southport and Ormskirk Hospital NHS Trust, Southport, Merseyside, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Garthwaite', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Mark R E', 'Initials': 'MRE', 'LastName': 'Harris', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Petre C', 'Initials': 'PC', 'LastName': 'Ilie', 'Affiliation': ""The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, King's Lynn, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Urology Department, Taunton and Somerset NHS Foundation Trust, Musgrove Park Hospital, Taunton, Somerset, UK.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Sabbagh', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, Tooting, London, UK.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Mason', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torbay Hospital, Torquay, UK.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'McLarty', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Vibhash', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Royal Free London NHS Foundation Trust, Royal Free Hospital, London, UK.'}, {'ForeName': 'Jaswant', 'Initials': 'J', 'LastName': 'Mom', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, West Cumberland Hospital, Hensingham, Whitehaven, Cumbria, UK.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Morley', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Natale', 'Affiliation': 'Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Tharani', 'Initials': 'T', 'LastName': 'Nitkunan', 'Affiliation': 'Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, High Heaton, Newcastle Upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Payne', 'Affiliation': 'Kettering General Hospital NHS Foundation Trust, Kettering, Northants, UK.'}, {'ForeName': 'Tina G', 'Initials': 'TG', 'LastName': 'Rashid', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Saeb-Parsy', 'Affiliation': 'Urology Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sarb S', 'Initials': 'SS', 'LastName': 'Sandhu', 'Affiliation': 'Kingston Hospital NHS Foundation Trust, Surrey, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Simoes', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, Kent, UK.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Southport and Ormskirk Hospital NHS Trust, Southport, Merseyside, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Nuffield Department of Surgical Sciences, Oxford University, Headington, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Headington, Oxford, UK.'}, {'ForeName': 'Heidi V', 'Initials': 'HV', 'LastName': 'Tempest', 'Affiliation': 'Nuffield Department of Surgical Sciences, Oxford University, Headington, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Headington, Oxford, UK.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Viswanath', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Roger M H', 'Initials': 'RMH', 'LastName': 'Walker', 'Affiliation': 'Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}]",European urology focus,['10.1016/j.euf.2019.04.006']
519,30671796,Randomized Trial of Pylorus-Preserving vs. Pylorus-Resecting Pancreatoduodenectomy: Long-Term Morbidity and Quality of Life.,"BACKGROUND


The randomized controlled PROPP trial (DKRS00004191) showed that pylorus-resecting pancreatoduodenectomy (PR) is not superior to the pylorus-preserving procedure (PP) in terms of perioperative outcome, specifically in reduction of delayed gastric emptying. Non-superiority of PR was also confirmed in a recent meta-analysis of randomized controlled trials. However, long-term data on morbidity and quality of life after PP compared to PR are sparse. The aim of this study was to investigate long-term outcomes of patients included in the PROPP trial.
METHODS


Between February 2013 and June 2016, a total of 188 patients underwent PD and were intraoperatively randomized to either preservation or resection of the pylorus (95 vs. 93 patients). For long-term follow-up, morbidity and quality of life (EORTC QLQ-C30/PAN26) were monitored until January 1, 2018. Statistical analysis was performed on an intention-to-treat basis.
RESULTS


The mean duration of follow-up was 34.3 (± 11.3) months. Sixty-three of the 188 patients had died (PP n = 33, PR n = 30), 29 patients were lost to follow-up (PP n = 17, PR n = 12), and the remaining 96 patients were included in long-term follow-up (PP n = 45, PR n = 51). There was no difference between PP and PR patients regarding endocrine and exocrine pancreatic function, receipt of adjuvant/palliative chemotherapy, cancer recurrence, and other relevant characteristics. Late cholangitis occurred significantly more often in patients following pylorus resection (P = 0.042). Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups.
CONCLUSIONS


Similar to short-term results, long-term follow-up showed no significant differences between pylorus resection compared to pylorus preservation.",2020,"Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups.
","['Sixty-three of the 188 patients had died (PP n\u2009=\u200933, PR n\u2009=\u200930), 29 patients were lost to follow-up (PP n\u2009=\u200917, PR n\u2009=\u200912), and the remaining 96 patients were included in long-term follow-up (PP n\u2009=\u200945, PR n\u2009=\u200951', '188 patients underwent PD', 'Between February 2013 and June 2016', 'patients included in the PROPP trial']","['pylorus-resecting pancreatoduodenectomy (PR', 'Pylorus-Preserving vs. Pylorus-Resecting Pancreatoduodenectomy']","['morbidity and quality of life (EORTC QLQ-C30/PAN26', 'Reoperations, readmissions to hospital, and quality of life scores except pain', 'Late cholangitis', 'Long-Term Morbidity and Quality of Life', 'endocrine and exocrine pancreatic function, receipt of adjuvant/palliative chemotherapy, cancer recurrence', 'morbidity and quality of life']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0034196', 'cui_str': 'Pylorus'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034380'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",29.0,0.133218,"Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups.
","[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Klaiber', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 130, 69120 Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. Thilo.Hackert@med.uni-heidelberg.de.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-04102-y']
520,30730774,The Parent-Child Relationship and Posttreatment Child Outcomes Across Two Treatments for Oppositional Defiant Disorder.,"This study examined the degree to which the parent-child relationship uniquely predicted clinical outcomes in externalizing problems and adaptive skills in children meeting diagnostic criteria for oppositional defiant disorder and whether facets of this relationship moderated the effects of two unique psychosocial treatments. We recruited 134 children and their parents (38.06% female;  M  age = 9.52 years, range = 7-14; 83.58% White). Families were randomly assigned to 1 of 2 treatments: Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS). We formed principal components from pretreatment reports and behaviors of the parent-child relationship to predict within- and between-family outcomes in children's externalizing problems and adaptive skills. Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness). Parental monitoring predicted fewer externalizing problems, whereas family permissiveness predicted more externalizing problems. Parental warmth predicted greatest improvements in children's adaptive skills among families receiving PMT. Family hostility predicted more externalizing problems and poorer adaptive skills for children; however, families receiving CPS were buffered from the negative effect of family hostility on adaptive skills. The parent-child relationship can uniquely inform posttreatment outcomes following treatment for oppositional defiant disorder. Certain treatment approaches may better fit unique relationships that emphasize warmth and/or hostility, allowing clinicians to anticipate and tailor treatments to families.",2020,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[""children's externalizing problems and adaptive skills"", 'children meeting diagnostic criteria for oppositional defiant disorder', '134 children and their parents (38.06% female; M age\xa0']",['Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS'],"['externalizing problems and poorer adaptive skills', ""children's adaptive skills"", 'externalizing problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517748', 'cui_str': 'Thirty-eight point zero six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",134.0,0.0478645,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Booker', 'Affiliation': 'Department of Psychological Sciences, University of Missouri.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Department of Psychology, University of Alabama.'}, {'ForeName': 'Ross W', 'Initials': 'RW', 'LastName': 'Greene', 'Affiliation': 'Child Study Center, Virginia Tech.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Tech.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1555761']
521,30649970,Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial.,"Children adopted internationally are often dysregulated biologically and behaviorally due to prior experiences of institutional care or caregiving changes and thus are in need of enhanced parental care. The present study assessed whether parents randomized to receive Attachment and Biobehavioral Catch-up (ABC) demonstrated significant improvements in parenting quality when compared to parents receiving a control intervention. Participants were 120 internationally adopted children and their adoptive parents. Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female. Children were adopted from several countries and predominantly from China, Russia, South Korea, and Ethiopia. The majority of parents identified themselves as White/non-Hispanic (95.0%). At the start of intervention, parents ranged in age from 26.2 to 51.1 years old ( M = 39.7,  SD  = 6.0), and children ranged in age from 6.8 months to 48.4 months ( M  = 21.9,  SD  = 9.0). Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy), and positive regard (i.e., positive affect expressed towards a child) were assessed at preintervention, immediately postintervention, and at annual follow-up visits. Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up. Findings add to the growing evidence that ABC improves parenting abilities, extending findings to adoptive parents and demonstrating that improvements in parenting quality were sustained several years after completion of the intervention. Trial registration: ClinicalTrials.gov NCT00816621.",2020,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","['parents ranged in age from 26.2 to 51.1\xa0years old (M=\xa039.7, SD\xa0=\xa06.0), and children ranged in age from 6.8\xa0months to 48.4\xa0months (M =\xa021.9, SD\xa0=\xa09.0', 'Participants were 120 internationally adopted children and their adoptive parents', 'Young Children', 'Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female']","['ABC', 'Attachment and Biobehavioral Catch-up (ABC', 'control intervention']","['Enhancing Parenting Quality', 'parenting abilities', 'parenting quality', ""Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy""]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0337541', 'cui_str': 'Adopted child (person)'}, {'cui': 'C0337466', 'cui_str': 'Adoptive parent (person)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}]",120.0,0.0406424,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health Center.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wallin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1547972']
522,30783957,Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.,"BACKGROUND


Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain.
OBJECTIVES


In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy.
DESIGN


The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days.
PATIENTS


A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial.
SETTING


This study was conducted at a single educational hospital.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption.
RESULTS


No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group.
CONCLUSION


Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.",2020,"Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group.
","['66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy', 'patients with localized neuropathic pain', 'Post-Hemorrhoidectomy Pain']","['placebo', 'Placebo', 'Topical Baclofen', 'baclofen', 'baclofen (5%) cream or placebo', 'baclofen cream']","['Postoperative pain score', 'pain', 'postoperative pain and analgesic requirement', 'analgesic medication', 'intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3264452', 'cui_str': 'Internal hemorrhoids grade IV (disorder)'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy (procedure)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",66.0,0.396013,"Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group.
","[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Alvandipour', 'Affiliation': 'Department of Surgery, Imam Khomeini General Hospital Affiliated to Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. Minaalvh@yahoo.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Mansourifar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.'}, {'ForeName': 'Mahila', 'Initials': 'M', 'LastName': 'Monajati', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Shiva', 'Affiliation': 'Department of Clinical Pharmacy, Nephrology and Kidney Transplant Research Center, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04147-7']
523,30638738,"Essential amino acid-enriched meal replacement promotes superior net protein balance in older, overweight adults.","BACKGROUND & AIMS


Older individuals are susceptible to the loss of muscle and accumulation of fat. To address this problem, we have compared protein kinetics following consumption of an essential amino acid (EAA)-enriched meal replacement (EMR) to consumption of a high-protein meal replacement beverage (Bariatric Advantage, BA) using stable isotope methodology.
METHODS


Eight older (67 ± 2), obese (35 ± 2 kg/m 2 ) female and male participants completed two studies using a randomized, crossover design in which they ingested each meal replacement. The isotopic tracers L-[ 2 H 5 ]phenylalanine & L-[ 2 H 2 ]tyrosine were delivered via primed, continuous intravenous infusion throughout a basal period and following consumption of EMR or BA. We determined changes in whole body protein synthesis (PS), protein breakdown (PB), and net protein balance (NB) from fasted states via analysis of plasma samples by LC-ESI-MS.
RESULTS


PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA. As a result, NB was much greater (P = 0.00003) following the ingestion of EMR as compared to BA.
CONCLUSIONS


In comparison with BA, which has a higher amount of intact protein that any other meal replacement, EMR promoted a greater increment in NB. These data support the potential efficacy of EMR as a meal replacement for the preservation of lean tissue mass during weight loss in older, overweight individuals.",2019,"RESULTS


PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA.","['Older individuals', 'older, overweight adults', 'Eight older (67\xa0±\xa02), obese (35\xa0±\xa02\xa0kg/m 2 ', 'female and male participants', 'older, overweight individuals']","['Essential amino acid-enriched meal replacement', 'phenylalanine & L-[ 2 H 2 ]tyrosine', 'EMR']","['whole body protein synthesis (PS), protein breakdown (PB), and net protein balance (NB', 'PB', 'NB']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0448123,"RESULTS


PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA.","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Coker', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA; Essential Blends, LLC, Fairbanks, AK, USA. Electronic address: rcoker@alaska.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Scholten', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Johannsen', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tsigonis', 'Affiliation': 'Tanana Valley Clinic, Fairbanks, AK, USA.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular Medicine, Lee Gil Ya Cancer and Diabetes Institute, Gachon University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Essential Blends, LLC, Fairbanks, AK, USA; Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.013']
524,30419096,Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial.,"Importance


Functional decline is prevalent among acutely hospitalized older patients. Exercise and early rehabilitation protocols applied during acute hospitalization can prevent functional and cognitive decline in older patients.
Objective


To assess the effects of an innovative multicomponent exercise intervention on the functional status of this patient population.
Design, Setting, and Participants


A single-center, single-blind randomized clinical trial was conducted from February 1, 2015, to August 30, 2017, in an acute care unit in a tertiary public hospital in Navarra, Spain. A total of 370 very elderly patients undergoing acute-care hospitalization were randomly assigned to an exercise or control (usual-care) intervention. Intention-to-treat analysis was conducted.
Interventions


The control group received usual-care hospital care, which included physical rehabilitation when needed. The in-hospital intervention included individualized moderate-intensity resistance, balance, and walking exercises (2 daily sessions).
Main Outcomes and Measures


The primary end point was change in functional capacity from baseline to hospital discharge, assessed with the Barthel Index of independence and the Short Physical Performance Battery (SPPB). Secondary end points were changes in cognitive and mood status, quality of life, handgrip strength, incident delirium, length of stay, falls, transfer after discharge, and readmission rate and mortality at 3 months after discharge.
Results


Of the 370 patients included in the analyses, 209 were women (56.5%); mean (SD) age was 87.3 (4.9) years. The median length of hospital stay was 8 days in both groups (interquartile range, 4 and 4 days, respectively). Median duration of the intervention was 5 days (interquartile range, 0); there was a mean (SD) of 5 (1) morning and 4 (1) evening sessions per patient. No adverse effects were observed with the intervention. The exercise intervention program provided significant benefits over usual care. At discharge, the exercise group showed a mean increase of 2.2 points (95% CI, 1.7-2.6 points) on the SPPB scale and 6.9 points (95% CI, 4.4-9.5 points) on the Barthel Index over the usual-care group. Hospitalization led to an impairment in functional capacity (mean change from baseline to discharge in the Barthel Index of -5.0 points (95% CI, -6.8 to -3.2 points) in the usual-care group, whereas the exercise intervention reversed this trend (1.9 points; 95% CI, 0.2-3.7 points). The intervention also improved the SPPB score (2.4 points; 95% CI, 2.1-2.7 points) vs 0.2 points; 95% CI, -0.1 to 0.5 points in controls). Significant intervention benefits were also found at the cognitive level of 1.8 points (95% CI, 1.3-2.3 points) over the usual-care group.
Conclusions and Relevance


The exercise intervention proved to be safe and effective to reverse the functional decline associated with acute hospitalization in very elderly patients.
Trial Registration


ClinicalTrials.gov identifier: NCT02300896.",2019,"Hospitalization led to an impairment in functional capacity (mean change from baseline to discharge in the Barthel Index of -5.0 points (95% CI, -6.8 to -3.2 points) in the usual-care group, whereas the exercise intervention reversed this trend (1.9 points; 95% CI, 0.2-3.7 points).","['Participants\n\n\nA single-center, single-blind randomized clinical trial was conducted from February 1, 2015, to August 30, 2017, in an acute care unit in a tertiary public hospital in Navarra, Spain', 'Very Elderly Patients', 'acutely hospitalized older patients', ' 209 were women (56.5%); mean (SD) age was 87.3 (4.9) years', 'very elderly patients', '370 patients included in the analyses', 'older patients', '370 very elderly patients undergoing acute-care hospitalization']","['Exercise and early rehabilitation protocols', 'exercise intervention', 'innovative multicomponent exercise intervention', 'exercise or control (usual-care) intervention', 'usual-care hospital care', 'exercise intervention program', 'Exercise Intervention']","['Functional Decline', 'individualized moderate-intensity resistance, balance, and walking exercises', 'median length of hospital stay', 'change in functional capacity from baseline to hospital discharge, assessed with the Barthel Index of independence and the Short Physical Performance Battery (SPPB', 'adverse effects', 'Median duration', 'SPPB scale', 'SPPB score', 'changes in cognitive and mood status, quality of life, handgrip strength, incident delirium, length of stay, falls, transfer after discharge, and readmission rate and mortality', 'cognitive level', 'functional capacity']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",370.0,0.114009,"Hospitalization led to an impairment in functional capacity (mean change from baseline to discharge in the Barthel Index of -5.0 points (95% CI, -6.8 to -3.2 points) in the usual-care group, whereas the exercise intervention reversed this trend (1.9 points; 95% CI, 0.2-3.7 points).","[{'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Casas-Herrero', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Biomedical Research Centre of the Government of Navarre (Navarrabiomed) and Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Biomedical Research Centre of the Government of Navarre (Navarrabiomed) and Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Faculty of Sports Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Biomedical Research Centre of the Government of Navarre (Navarrabiomed) and Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Agurne', 'Initials': 'A', 'LastName': 'García-Baztán', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Renedo', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'González-Glaría', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gonzalo-Lázaro', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Apezteguía Iráizoz', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gutiérrez-Valencia', 'Affiliation': 'Geriatric Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Leocadio', 'Initials': 'L', 'LastName': 'Rodríguez-Mañas', 'Affiliation': 'Biomedical Research Networking Centers of Frailty and Healthy Aging, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Biomedical Research Centre of the Government of Navarre (Navarrabiomed) and Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}]",JAMA internal medicine,['10.1001/jamainternmed.2018.4869']
525,31831384,Contributions of Early Care and Education Programs to Diet Quality in Children Aged 3 to 4 Years in Central North Carolina.,"BACKGROUND


Parents and early care and education (ECE) are the key influencers of young children's diets, but there is limited information about how each contribute to children's overall diet quality.
OBJECTIVE


This study aimed to determine what proportion of children's dietary intake occurs within the ECE setting and whether diet quality is higher at ECE centers and, consequently, on weekdays than weekends.
DESIGN


This cross-sectional analysis of a larger cluster randomized controlled trial used multiple 24-hour dietary intakes measured through a combination of the Dietary Observation in Child Care protocol and parent-reported food diaries.
PARTICIPANTS/SETTING


Participants (N=840) included children aged 3 to 4 years enrolled in ECE centers in central North Carolina for whom 24-hour dietary intake was captured via observation of meals and snacks consumed at ECE and parent-report of all remaining meals and snacks. Data were collected from 2015 to 2016.
MAIN OUTCOME MEASURES


Diet quality at ECE and elsewhere was evaluated using the Healthy Eating Index 2015.
STATISTICAL ANALYSES PERFORMED


Mixed-effects models were used to determine differences in mean Healthy Eating Index 2015 component and total scores. Models were adjusted for children's age and sex and accounted for clustering within ECE centers and families.
RESULTS


Children consumed approximately 40% of daily energy, nutrients, and food groups at ECE centers. The mean total Healthy Eating Index 2015 score was higher for foods and beverages consumed at ECE centers (58.3±0.6) than elsewhere (52.5±0.6) (P<0.0001). The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
CONCLUSIONS


Children consume a majority of dietary intake away from ECE centers. Overall, diet quality is low, but the quality of foods consumed by children at ECE centers is higher than that consumed elsewhere. ECE centers remain an important source of nutrition and further investigation is warranted to identify ways to support both ECE centers and families to provide healthier eating environments.",2020,"The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
","['Participants (N=840) included children aged 3 to 4 years enrolled in ECE centers in central North Carolina for whom 24-hour dietary intake was captured via observation of meals and snacks consumed at ECE and parent-report of all remaining meals and snacks', 'Children Aged 3 to 4 Years in Central North Carolina']",[],"['mean total Healthy Eating Index 2015 score', 'mean Healthy Eating Index 2015 component and total scores', 'Diet quality at ECE and elsewhere was evaluated using the Healthy Eating Index\xa02015']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.110915,"The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
","[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Luecking', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mazzucca', 'Affiliation': ''}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': ''}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.09.018']
526,32091358,"Randomized Trial of 2 Schedules of Meningococcal B Vaccine in Adolescents and Young Adults, Canada 1 .","Emergency vaccination programs often are needed to control outbreaks of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) on college campuses. Such campaigns expend multiple campus and public health resources. We conducted a randomized, controlled, multicenter, observer-blinded trial comparing immunogenicity and tolerability of an accelerated vaccine schedule of 0 and 21 days to a longer interval of 0 and 60 days for 4-component MenB vaccine (MenB-4C) in students 17-25 years of age. At day 21 after the first MenB-4C dose, we observed protective human serum bactericidal titers >4 to MenB strains 5/99, H44/76, and NZ 98/254 in 98%-100% of participants. Geometric mean titers increased >22-fold over baseline. At day 180, >95% of participants sustained protective titers regardless of their vaccine schedule. The most common adverse event was injection site pain. An accelerated MenB-4C immunization schedule could be considered for rapid control of campus outbreaks.",2020,Emergency vaccination programs often are needed to control outbreaks of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) on college campuses.,"['students 17-25 years of age', 'Adolescents and Young Adults, Canada 1 ']","['Meningococcal B Vaccine', 'NZ', '4-component MenB vaccine (MenB-4C']","['Geometric mean titers', 'immunogenicity and tolerability']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.265387,Emergency vaccination programs often are needed to control outbreaks of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) on college campuses.,"[{'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Langley', 'Affiliation': ''}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Gantt', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': ''}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ''}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mutch', 'Affiliation': ''}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'MacKinnon-Cameron', 'Affiliation': ''}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Marty', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scheifele', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Joenel', 'Initials': 'J', 'LastName': 'Alcantara', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Emerging infectious diseases,['10.3201/eid2603.190160']
527,31919404,"Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial.","BACKGROUND


No standard treatment is available for advanced biliary tract cancer (BTC) after first-line therapy with gemcitabine plus cisplatin (GEMCIS). The objective of this study was to evaluate safety and anti-tumour activity of fluorouracil, leucovorin, irinotecan plus oxaliplatin (FOLFIRINOX) as salvage treatment in patients with previously treated advanced BTC.
METHODS


In this two-stage phase 2 study, patients with advanced BTC who had disease progression or unacceptable toxicity after ≥3 cycles of GEMCIS were eligible. Primary endpoints were safety and efficacy (defined as objective response rate, ORR). In stage one, ten patients were treated with FOLFIRINOX every 2 weeks. In stage two, an additional 20 patients were enrolled at a starting dose as defined in stage one, provided that in stage ≥1 objective response or ≥2 stable diseases were observed and ≤3 patients had serious adverse events (SAEs) within the first 6 weeks of treatment. Secondary endpoints were progression-free survival (PFS) and overall survival (OS).
RESULTS


Forty patients were screened for eligibility and 30 patients were enrolled. In stage one, one patient had a partial response and five patients had stable disease. One patient had a SAE during the first 6 weeks of treatment, and five patients required a dose reduction due to adverse events. The most common grade 3-4 adverse events in stage one were neutropaenia, mucositis and diarrhoea. Stage two was initiated with FOLFIRINOX in an adapted dose. In stage two, grade 3-4 neutropaenia, diarrhoea, nausea and vomiting were the most common adverse events. The ORR, median PFS and OS in all patients were 10%, 6.2 and 10.7 months, respectively.
CONCLUSIONS


In patients with advanced BTC who progressed after or were intolerant to GEMCIS, FOLFIRINOX can be administered safely and could be considered as an option for salvage treatment in these patients.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02456714.",2020,"In stage two, grade 3-4 neutropaenia, diarrhoea, nausea and vomiting were the most common adverse events.","['advanced biliary tract cancer', 'Forty patients were screened for eligibility and 30 patients were enrolled', 'patients with advanced BTC who progressed after or were intolerant to', 'patients with previously treated advanced BTC', 'patients with advanced BTC who had disease progression or unacceptable toxicity after ≥3 cycles of GEMCIS were eligible']","['fluorouracil, leucovorin, irinotecan plus oxaliplatin (FOLFIRINOX', 'gemcitabine plus cisplatin (GEMCIS', 'GEMCIS']","['neutropaenia, mucositis and diarrhoea', 'neutropaenia, diarrhoea, nausea and vomiting', 'ORR, median PFS and OS', 'Efficacy and safety', 'serious adverse events (SAEs', 'safety and efficacy (defined as objective response rate, ORR', 'adverse events', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",40.0,0.171873,"In stage two, grade 3-4 neutropaenia, diarrhoea, nausea and vomiting were the most common adverse events.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Belkouz', 'Affiliation': 'Amsterdam UMC, Department of Medical Oncology, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Maastricht UMC+, GROW - School for Oncology and Developmental Biology, Department Of Internal Medicine Division of Medical, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Amsterdam UMC, Department of Pharmacy, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Ferry A L M', 'Initials': 'FALM', 'LastName': 'Eskens', 'Affiliation': 'Erasmus MC, Department of Medical Oncology, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'van Gulik', 'Affiliation': 'Amsterdam UMC, Department of Surgery, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn G H', 'Initials': 'MGH', 'LastName': 'van Oijen', 'Affiliation': 'Amsterdam UMC, Department of Medical Oncology, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Amsterdam UMC, Department of Medical Oncology, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Wilmink', 'Affiliation': 'Amsterdam UMC, Department of Medical Oncology, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Klümpen', 'Affiliation': 'Amsterdam UMC, Department of Medical Oncology, University of Amsterdam, Cancer Center Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. h.klumpen@amsterdamumc.nl.'}]",British journal of cancer,['10.1038/s41416-019-0698-9']
528,32144167,The Use of a Smart Bolus Calculator Informed by Real-time Insulin Sensitivity Assessments Reduces Postprandial Hypoglycemia Following an Aerobic Exercise Session in Individuals With Type 1 Diabetes.,"OBJECTIVE


Insulin dosing in type 1 diabetes (T1D) is oftentimes complicated by fluctuating insulin requirements driven by metabolic and psychobehavioral factors impacting individuals' insulin sensitivity (IS). In this context, smart bolus calculators that automatically tailor prandial insulin dosing to the metabolic state of a person can improve glucose management in T1D.
RESEARCH DESIGN AND METHODS


Fifteen adults with T1D using continuous glucose monitors (CGMs) and insulin pumps completed two 24-h admissions in a hotel setting. During the admissions, participants engaged in an early afternoon 45-min aerobic exercise session, after which they received a standardized dinner meal. The dinner bolus was computed using a standard bolus calculator or smart bolus calculator informed by real-time IS estimates. Glucose control was assessed in the 4 h following dinner using CGMs and was compared between the two admissions.
RESULTS


The IS-informed bolus calculator allowed for a reduction in postprandial hypoglycemia as quantified by the low blood glucose index (2.02 vs. 3.31,  P  = 0.006) and percent time <70 mg/dL (8.48% vs. 15.18%,  P  = 0.049), without increasing hyperglycemia (high blood glucose index: 3.13 vs. 2.09,  P  = 0.075; percent time >180 mg/dL: 13.24% vs. 10.42%,  P  = 0.5; percent time >250 mg/dL: 2.08% vs. 1.19%,  P  = 0.317). In addition, the number of hypoglycemia rescue treatments was reduced from 12 to 7 with the use of the system.
CONCLUSIONS


The study shows that the proposed IS-informed bolus calculator is safe and feasible in adults with T1D, appropriately reducing postprandial hypoglycemia following an exercise-induced IS increase.",2020,"The study shows that the proposed IS-informed bolus calculator is safe and feasible in adults with T1D, appropriately reducing postprandial hypoglycemia following an exercise-induced IS increase.","['Fifteen adults with T1D using continuous glucose monitors (CGMs) and insulin pumps completed two 24-h admissions in a hotel setting', 'adults with T1D', 'Individuals With Type 1 Diabetes', 'type 1 diabetes (T1D']",['Aerobic Exercise Session'],"['hyperglycemia', 'Postprandial Hypoglycemia', 'number of hypoglycemia rescue treatments', 'Glucose control', 'postprandial hypoglycemia', 'low blood glucose index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442514', 'cui_str': 'Hotel (environment)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0271710', 'cui_str': 'Postprandial Hypoglycemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",15.0,0.0515507,"The study shows that the proposed IS-informed bolus calculator is safe and feasible in adults with T1D, appropriately reducing postprandial hypoglycemia following an exercise-induced IS increase.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fabris', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA cf9qe@virginia.edu.'}, {'ForeName': 'Ralf M', 'Initials': 'RM', 'LastName': 'Nass', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pinnata', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Carr', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Chaitanya L K', 'Initials': 'CLK', 'LastName': 'Koravi', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Barnett', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Oliveri', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Chernavvsky', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}]",Diabetes care,['10.2337/dc19-1675']
529,30115499,Selective Prefrontal Disinhibition in a Roving Auditory Oddball Paradigm Under N-Methyl-D-Aspartate Receptor Blockade.,"BACKGROUND


Disturbances in N-methyl-D-aspartate receptors (NMDARs)-as implicated in patients with schizophrenia-can cause regionally specific electrophysiological effects. Both animal models of NMDAR blockade and clinical studies in patients with schizophrenia have suggested that behavioral phenotypes are associated with reduction in inhibition within the frontal cortex.
METHODS


Here we investigate event-related potentials to a roving auditory oddball paradigm under ketamine in healthy human volunteers (N= 18; double-blind, placebo-controlled, crossover design). Using recent advances in Bayesian modeling of group effects in dynamic causal modeling, we fit biophysically plausible network models of the auditory processing hierarchy to whole-scalp event-related potential recordings. This allowed us to identify regionally specific effects of ketamine in a distributed network of interacting cortical sources.
RESULTS


We show that the effect of ketamine is best explained as a selective change in intrinsic inhibition, with a pronounced ketamine-induced reduction of inhibitory interneuron connectivity in frontal sources, compared with temporal sources. Simulations of these changes in an integrated microcircuit model shows that they are associated with a reduction in superficial pyramidal cell activity that can explain drug effects observed in the event-related potential.
CONCLUSIONS


These results are consistent with findings from invasive recordings in animal models exposed to NMDAR blockers, and provide evidence that inhibitory interneuron-specific NMDAR dysfunction may be sufficient to explain electrophysiological abnormalities induced by NMDAR blockade in human subjects.",2019,"Simulations of these changes in an integrated microcircuit model shows that they are associated with a reduction in superficial pyramidal cell activity that can explain drug effects observed in the event-related potential.
","['patients with schizophrenia', 'healthy human volunteers (N= 18']","['ketamine', 'placebo', 'roving auditory oddball paradigm under ketamine']",['Selective Prefrontal Disinhibition'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]","[{'cui': 'C0234410', 'cui_str': 'Disinhibition, function (observable entity)'}]",,0.0381073,"Simulations of these changes in an integrated microcircuit model shows that they are associated with a reduction in superficial pyramidal cell activity that can explain drug effects observed in the event-related potential.
","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rosch', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, United Kingdom; Developmental Neurosciences Programme, UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom. Electronic address: r.rosch@ucl.ac.uk.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Auksztulewicz', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, United Kingdom; Department of Biomedical Sciences, City University of Hong Long, Hong Kong.'}, {'ForeName': 'Pui Duen', 'Initials': 'PD', 'LastName': 'Leung', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, United Kingdom.'}, {'ForeName': 'Karl J', 'Initials': 'KJ', 'LastName': 'Friston', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, University College London, London, United Kingdom.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Baldeweg', 'Affiliation': 'Developmental Neurosciences Programme, UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2018.07.003']
530,30025502,"Microfinance and health interventions: Factors influencing loan repayment success with young men in Dar es Salaam, Tanzania.","Poverty is associated with numerous poor health outcomes. Youth unemployment in Tanzania is approximately 13.7%, and concentrates in urban areas. These youth lack relevant job skills and access to financial capital. Microfinance continues to be implemented globally to address poverty, and increasingly has been linked to health interventions. Men less frequently are recipients of microfinance loans. We offered microcredit to young men in an area of Dar es Salaam with high poverty as part of a randomised controlled-trial to assess the efficacy of a microfinance and health leadership intervention in preventing STI acquisition. We used mixed methods to understand predictors of successful loan repayment. Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment. Using a modified Poisson approach, our quantitative analysis showed that successful repayment was associated with business experience, education, increasing number of children, community of residence, percentage of network members trained in business, and repayment success of peer leaders. Our results suggest that enforcing group accountability and repayment rules, offering ongoing training, and using successful entrepreneurs as role models could increase repayment success in similar populations. These strategies could provide financial opportunity for men while minimising risk for microfinance institutions.",2019,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","['young men in an area of Dar es Salaam with high poverty', 'young men in Dar es Salaam, Tanzania']","['Microfinance and health interventions', 'microfinance and health leadership intervention']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}]",[],,0.0426746,"Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'School of International Service, American University, Washington DC, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Mwikoko', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deusdith', 'Initials': 'D', 'LastName': 'Kajuna', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry and Mental Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leatherman', 'Affiliation': 'Department of Health Policy and Management, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, The University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, NC, USA.'}]",Global public health,['10.1080/17441692.2018.1501079']
531,31972236,"Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial.","BACKGROUND & AIMS


Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection.
METHODS


We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events.
RESULTS


The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events.
CONCLUSIONS


In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).",2020,"Prevention of infection was not inferior in the control group; the difference between groups was 0.87% (95% CI, -0.84% to 2.59%).","['patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain', 'patients undergoing EUS-FNA for pancreatic cyst evaluation', 'From September 2014 to June 2018, patients', 'patients undergoing endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts']","['prophylaxis with ciprofloxacin (n=112) or saline solution (n=114, placebo', 'placebo', 'ciprofloxacin vs placebo', 'ciprofloxacin']","['incidence of infection', 'FNA-related infection', 'incidence of infections', 'fever', 'incidence of fever, procedure complications, and medication-related adverse events', 'acute pancreatitis and bacteremia', 'Prevention of infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030283', 'cui_str': 'Pancreatic Cyst'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",,0.578291,"Prevention of infection was not inferior in the control group; the difference between groups was 0.87% (95% CI, -0.84% to 2.59%).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Colán-Hernández', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sendino', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Loras', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Department of Gastroenterology, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, Terrassa, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pardo', 'Affiliation': 'Hospital Joan XXIII de Tarragona, Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Gornals', 'Affiliation': ""Hospital de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Barcelona, Spain.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Concepción', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sánchez-Montes', 'Affiliation': 'Hospital Clínic, Universitat de Barcelona, Spain.'}, {'ForeName': 'Marianette', 'Initials': 'M', 'LastName': 'Murzi', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Andujar', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Department of Gastroenterology, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, Terrassa, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Velasquez-Rodriguez', 'Affiliation': ""Hospital de Bellvitge-Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodriguez de Miguel', 'Affiliation': 'Hospital Clínic, Universitat de Barcelona, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Fernández-Esparrach', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Angels', 'Initials': 'A', 'LastName': 'Ginés', 'Affiliation': ""Hospital Clínic, Universitat de Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, CIBERehd Spain; Institut d'Investigació Biomèdica August Pi i Sunyer, Barcelona.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guarner-Argente', 'Affiliation': 'Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Spain. Electronic address: cguarnera@santpau.cat.'}]",Gastroenterology,['10.1053/j.gastro.2020.01.025']
532,31983281,"Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit.","Acute intake of the wheat bran extract Arabinoxylan-Oligosaccharide (AXOS) modulates the gut microbiota, improves stool characteristics and postprandial glycemia in healthy humans. Yet, little is known on how long-term AXOS intake influences gastrointestinal (GI) functioning, gut microbiota, and metabolic health. In this randomized, placebo-controlled, double-blind study, we evaluated the effects of AXOS intake on GI function and metabolic health in adults with slow GI transit without constipation. Forty-eight normoglycemic adults were included with whole-gut transit time (WGTT) of >35 h receiving either 15 g/day AXOS or placebo (maltodextrin) for 12-wks. The primary outcome was WGTT, and secondary outcomes included stool parameters, gut permeability, short-chain fatty acids (SCFA), microbiota composition, energy expenditure, substrate oxidation, glucose, insulin, lipids, gut hormones, and adipose tissue (AT) function. WGTT was unchanged, but stool consistency softened after AXOS. 12-wks of AXOS intake significantly changed the microbiota by increasing  Bifidobacterium  and decreasing microbial alpha-diversity. With a good classification accuracy, overall microbiota composition classified responders with decreased WGTT after AXOS. The incretin hormone Glucagon-like protein 1 was reduced after AXOS compared to placebo. Energy expenditure, plasma metabolites, AT parameters, SCFA, and gut permeability were unchanged. In conclusion, intake of wheat bran extract increases fecal  Bifidobacterium  and softens stool consistency without major effects on energy metabolism in healthy humans with a slow GI transit. We show that overall gut microbiota classified responders with decreased WGTT after AXOS highlighting that GI transit and change thereof were associated with gut microbiota independent of  Bifidobacterium . NCT02491125.",2020,12-wks of AXOS intake significantly changed the microbiota by increasing  Bifidobacterium  and decreasing microbial alpha-diversity.,"['adults with slow GI transit without constipation', 'healthy humans', 'healthy humans with a slow GI transit', 'Forty-eight normoglycemic adults', 'healthy adults with a slow gut transit']","['wheat bran extract Arabinoxylan-Oligosaccharide (AXOS', 'placebo', 'wheat bran derived prebiotic supplementation', 'wheat bran extract', 'whole-gut transit time (WGTT) of >35 h receiving either 15 g/day AXOS or placebo (maltodextrin', 'AXOS intake']","['gastrointestinal transit, gut microbiota, and metabolic health', 'Energy expenditure, plasma metabolites, AT parameters, SCFA, and gut permeability', 'stool characteristics and postprandial glycemia', 'incretin hormone Glucagon-like protein 1', 'stool parameters, gut permeability, short-chain fatty acids (SCFA), microbiota composition, energy expenditure, substrate oxidation, glucose, insulin, lipids, gut hormones, and adipose tissue (AT) function', 'GI function and metabolic health']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C3257534', 'cui_str': 'Triticum vulgare extract'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043138', 'cui_str': 'Wheat Bran'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0017191', 'cui_str': 'Gastrointestinal Transit'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0031843', 'cui_str': 'function'}]",48.0,0.211394,12-wks of AXOS intake significantly changed the microbiota by increasing  Bifidobacterium  and decreasing microbial alpha-diversity.,"[{'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Gerben D A', 'Initials': 'GDA', 'LastName': 'Hermes', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research , Wageningen, The Netherlands.'}, {'ForeName': 'Canfora', 'Initials': 'C', 'LastName': 'Emanuel E', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'NNF Center for Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Erwin G', 'Initials': 'EG', 'LastName': 'Zoetendal', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research , Wageningen, The Netherlands.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Smidt', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research , Wageningen, The Netherlands.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Troost', 'Affiliation': 'Division of Gastroenterology-Hepatology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Schaap', 'Affiliation': 'Division of Gastroenterology-Hepatology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Steven Olde', 'Initials': 'SO', 'LastName': 'Damink', 'Affiliation': 'Division of Gastroenterology-Hepatology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Johan W E', 'Initials': 'JWE', 'LastName': 'Jocken', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Kaatje', 'Initials': 'K', 'LastName': 'Lenaerts', 'Affiliation': 'Department of Internal Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Ad A M', 'Initials': 'AAM', 'LastName': 'Masclee', 'Affiliation': 'Department of Surgery, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Blaak', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ , Maastricht, The Netherlands.'}]",Gut microbes,['10.1080/19490976.2019.1704141']
533,31982288,Effect of zonisamide on parkinsonism in patients with dementia with Lewy bodies: A phase 3 randomized clinical trial.,"INTRODUCTION


Zonisamide is approved in Japan for treating motor dysfunction in Parkinson's disease, and might also be effective for parkinsonism in patients with dementia with Lewy bodies (DLB). Our study evaluated the safety and efficacy of zonisamide for treating parkinsonism in patients with DLB.
METHODS


This multicenter, randomized, double-blind, phase 3 trial was conducted in Japan between April 2015 and November 2017. Following a 4-week run-in period, outpatients diagnosed with probable DLB who had developed parkinsonism were randomized to receive oral zonisamide (25 or 50 mg/day) or placebo for 12 weeks, followed by a 40-week open-label extension. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part III total score at Week 12.
RESULTS


Of 351 patients randomized, 346 (mean age, 77.2 years; 188 males) were included in the modified intention-to-treat population. At Week 12, the group difference (least squares mean ± SEM) for changes from baseline (vs placebo) in UPDRS part III total score was -2.7 ± 0.9 (95% confidence interval [CI]: -4.4, -0.9, P = 0.005) in the zonisamide 25-mg group and -2.6 ± 0.9 (95% CI: -4.4, -0.8, P = 0.005) in the zonisamide 50-mg group. Adverse events were reported in 47.1%, 48.7%, and 54.5% of patients in the placebo and zonisamide 25- and 50-mg groups, and led to treatment discontinuation in 5.0%, 4.3%, and 9.8% of patients, respectively.
CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.",2020,"CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.","['patients with dementia with Lewy bodies (DLB', 'outpatients diagnosed with probable DLB who had developed parkinsonism', '351 patients randomized, 346', 'Japan between April 2015 and November 2017', 'patients with DLB', 'mean age, 77.2 years; 188 males) were included in the modified intention-to-treat population', 'patients with dementia with Lewy bodies']","['zonisamide', 'placebo', 'Zonisamide', 'oral zonisamide']","['safety and efficacy', 'Adverse events', 'motor function', 'safe and well tolerated', 'UPDRS part III total score', ""change in Unified Parkinson's Disease Rating Scale (UPDRS) part III total score""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752347', 'cui_str': 'Dementia, Lewy Body'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}]",351.0,0.378219,"CONCLUSION


Daily administration of 25- or 50-mg zonisamide significantly improved motor function compared with placebo; both doses were safe and well tolerated in patients with DLB.","[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Neurology, National Center Hospital, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Odawara', 'Affiliation': 'Health Management Center, Yokohama City University, 22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, 236-0027, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Neurology, Sagamihara National Hospital, 18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, 252-0392, Japan.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Kajiwara', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tagawa', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan. Electronic address: masaaki-tagawa@ds-pharma.co.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kosaka', 'Affiliation': 'Shonan Inaho Clinic, 1-3-57 Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.12.005']
534,31974099,A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial.,"OBJECTIVE


The rapid insulin-alone artificial pancreas improves glycemia in type 1 diabetes but daytime control remains suboptimal. We propose two novel dual-hormone artificial pancreas systems.
RESEARCH DESIGN AND METHODS


We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes. Participants were assigned to the interventions in random order during three 24-h inpatient visits. Each visit was preceded by an outpatient hormonal open-loop run-in period of 10-14 days. The dual-hormone artificial pancreas delivered pramlintide in a basal-bolus manner, using a novel dosing algorithm, with a fixed ratio relative to insulin. The primary outcome was time in the range 3.9-10.0 mmol/L.
RESULTS


Compared with the rapid insulin-alone artificial pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) ( P  = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%];  P  = 0.22). The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime time in range increased from 63% [23%] to 78% [16%],  P  = 0.0004). There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively. Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
CONCLUSIONS


A novel rapid insulin-and-pramlintide artificial pancreas improves glucose control compared with a rapid insulin-alone artificial pancreas (ClinicalTrials.gov number NCT02814123).",2020,"Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
","['adults with type 1 diabetes', 'Type 1 Diabetes']","['Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas', 'rapid insulin-alone artificial pancreas', 'rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems']","['regular insulin-and-pramlintide system', 'rapid insulin-alone artificial pancreas system, the rapid insulin-and-pramlintide system increased the time in range', 'daytime control (daytime in range', 'Gastrointestinal symptoms', 'hypoglycemic events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0537551', 'cui_str': 'Pramlintide'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0336563', 'cui_str': 'Pancreas, Artificial'}, {'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}, {'cui': 'C0537551', 'cui_str': 'Pramlintide'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0982195,"Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada ahmad.haidar@mcgill.ca.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tsoukas', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernier-Twardy', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Yale', 'Affiliation': 'The Research Institute of McGill University Health Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bossy', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Pytka', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Strauss', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Montreal Children's Hospital, McGill University Health Centre, Montréal, Québec, Canada.""}]",Diabetes care,['10.2337/dc19-1922']
535,1332974,Biodegradable rods versus Kirschner wire fixation of wrist fractures. A randomised trial.,"In a prospective trial, biodegradable polyglycolic acid rods were compared with Kirschner wires for fixation of wrist fractures (Frykman types I, II, V and VI). Fifteen patients were randomly assigned to each treatment group. There was no significant difference between the groups with regard to age, sex ratio and fracture type. Kapandji's pinning technique was used in all cases. There were no significant differences in the results obtained in both groups at final follow-up. At three months and six months the functional results of the Kirschner-wire group were, however, significantly better (p < 0.05), due to numerous transient complications from foreign-body reactions to the polyglycolic acid rods. The use of polyglycolic acid rods is therefore not recommended for the fixation of distal radial fractures.",1992,"At three months and six months the functional results of the Kirschner-wire group were, however, significantly better (p < 0.05), due to numerous transient complications from foreign-body reactions to the polyglycolic acid rods.",['Fifteen patients'],['Kirschner wires'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}]",[],15.0,0.011741,"At three months and six months the functional results of the Kirschner-wire group were, however, significantly better (p < 0.05), due to numerous transient complications from foreign-body reactions to the polyglycolic acid rods.","[{'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Casteleyn', 'Affiliation': 'Department of Orthopaedics and Traumatology, Academic Hospital, Vrije Universiteit, Brussel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Handelberg', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Haentjens', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
536,31950527,The effect of peer counseling on breastfeeding behavior of primiparous mothers: A randomized controlled field trial.,"OBJECTIVE


To assess the impact of peer counseling on breastfeeding behavior of primiparous mothers.
DESIGN AND SAMPLE


A randomized controlled field trial was conducted with 80 mother-child pairs, who referred to health centers in 2018. The samples were recruited via convenience sampling method and were randomly assigned into experimental and control groups.
MEASUREMENTS


World Health Organization B-R-E-A-S-T-Feed Observation form was used at baseline, immediately, 1, 2, and 3 months after the intervention.
INTERVENTION


The experimental group received support during the first 3 months after childbirth from 10 peers with successful breastfeeding experiences and similar characteristics to those of the participants, while the controls benefited from the routine education provided by their health centers.
RESULTS


Baseline breastfeeding behavior mean scores were not different in the two groups (p > .05). Mean score changes after the intervention were significantly higher in the experimental group than in the control group at different time points, including immediately after the intervention (p < .001), 1 month (p < .001), 2 months (p < .001), and 3 months after the intervention (p < .001).
CONCLUSION


Use of peer counseling program to correct the breastfeeding behaviors of primiparous mothers can improve their performance of breastfeeding techniques.",2020,"Mean score changes after the intervention were significantly higher in the experimental group than in the control group at different time points, including immediately after the intervention (p < .001), 1 month (p < .001), 2 months (p < .001), and 3 months after the intervention (p < .001).
","['80 mother-child pairs, who referred to health centers in 2018', 'primiparous mothers']","['peer counseling', 'peer counseling program']","['Mean score changes', 'Baseline breastfeeding behavior mean scores', 'World Health Organization B-R-E-A-S-T-Feed Observation']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0566575', 'cui_str': 'Feeding finding'}]",,0.0695766,"Mean score changes after the intervention were significantly higher in the experimental group than in the control group at different time points, including immediately after the intervention (p < .001), 1 month (p < .001), 2 months (p < .001), and 3 months after the intervention (p < .001).
","[{'ForeName': 'Nasimeh', 'Initials': 'N', 'LastName': 'Azimi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nasiri', 'Affiliation': 'Social Determinants of Health Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12692']
537,31970939,"Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC-302 in Healthy Participants: Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Dose Studies.","TAC-302 stimulates neurite outgrowth activity and is expected to restore urinary function in patients with lower urinary tract dysfunction. We conducted 2 phase 1, randomized, placebo-controlled studies to confirm the safety and pharmacokinetics (PK) of TAC-302 in healthy adult Japanese male volunteers. In the first-in-human single-dose study (n = 60), TAC-302 was administered at doses from 100 to 1200 mg after an overnight fast. The effects of a meal on the PK of TAC-302 400 mg were also examined. A multiple-dose study (n = 36) evaluated the effects of meal fat content on the PK of single doses of TAC-302 (100, 200, or 400 mg) and multiple doses of TAC-302 administered for 5 days (100, 200, and 400 mg twice daily). TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state. No accumulation of TAC-302 was observed. Food, particularly with high fat content, increased TAC-302 plasma concentrations. No differences were observed in the adverse event incidence between the TAC-302 and placebo groups in either study. TAC-302 showed a wide safety margin.",2020,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","['healthy adult Japanese male volunteers', 'Healthy Participants', 'patients with lower urinary tract dysfunction']","['Placebo', 'placebo', 'TAC-302']","['Safety, Tolerability, Pharmacokinetics, and Food Effects', 'adverse event incidence', 'TAC-302 plasma concentrations', 'safety and pharmacokinetics (PK', 'accumulation of TAC-302']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0894403,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sesoko', 'Affiliation': 'Sosenkai Clinic Edogawa, Mizue, Edogawa-ku, Tokyo, Japan.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Pharmacovigilance Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Takashige', 'Initials': 'T', 'LastName': 'Okayama', 'Affiliation': 'Pharmacokinetics Research Laboratories, Taiho Pharmaceutical Co., Ltd., Okubo, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nishida', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyoshi', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.776']
538,31929499,Clinical Effect of Tunnel-Like Fistulectomy Plus Draining Seton Combined with Incision of Internal Opening of Anal Fistula (TFSIA) in the Treatment of High Trans-Sphincteric Anal Fistula.,"BACKGROUND The aim of this study was to investigate the clinical effect of tunnel-like fistulectomy plus draining seton combined with incision of internal opening of anal fistula (TFSIA) in the treatment of high transsphincteric anal fistula. MATERIAL AND METHODS There were 80 patients with high transsphincteric anal fistula randomly divided into TFSIA group and control group, 40 cases in each group. The control group was treated with cutting seton, and the seton was tightened weekly after discharge from the hospital until the seton dropped off. In the TFSIA group, the anal fistula was dissected and resected in tunnel-like form through the external opening to the intersphinceteric space, drained with seton through the tunnel, and cut open the internal opening of the anal fistula and the intersphincteric space and expanded the drainage. The operative time, blood loss, postoperative uroschesis, anal wound pain score, healing time, Wexner anal incontinence score, keyhole-like deformity, and recurrence rate were compared between the 2 groups. RESULTS The differences of the blood loss, operative time, anal wound pain score at 6 hours after operation, postoperative uroschesis and the recurrence rate after operation were not statistically significant (P>0.05), but the TFSIA were better than the control group in the anal wound pain score at 1 week after operation, healing time, Wexner anal incontinence score, and anal keyhole-like deformity rate (P<0.05). CONCLUSIONS TFSIA is effective in treating high transsphincteric anal fistula, and it can reduce adverse complications after operation.",2020,"The operative time, blood loss, postoperative uroschesis, anal wound pain score, healing time, Wexner anal incontinence score, keyhole-like deformity, and recurrence rate were compared between the 2 groups.","['high transsphincteric anal fistula', 'High Trans-Sphincteric Anal Fistula', '80 patients with high transsphincteric anal fistula randomly divided into']","['Tunnel', 'Like Fistulectomy Plus Draining Seton Combined with Incision of Internal Opening of Anal Fistula (TFSIA', 'tunnel-like fistulectomy plus draining seton combined with incision of internal opening of anal fistula (TFSIA', 'TFSIA']","['healing time, Wexner anal incontinence score, and anal keyhole-like deformity rate', 'adverse complications', 'anal wound pain score', 'blood loss, operative time, anal wound pain score at 6 hours after operation, postoperative uroschesis and the recurrence rate', 'operative time, blood loss, postoperative uroschesis, anal wound pain score, healing time, Wexner anal incontinence score, keyhole-like deformity, and recurrence rate', 'anal fistula']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0267571', 'cui_str': 'Transsphincteric anal fistula (disorder)'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0241745', 'cui_str': 'Wound pain (finding)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}]",80.0,0.0304671,"The operative time, blood loss, postoperative uroschesis, anal wound pain score, healing time, Wexner anal incontinence score, keyhole-like deformity, and recurrence rate were compared between the 2 groups.","[{'ForeName': 'Jifu', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital of Zhejiang Province, Zhejiang, Yuyao, China (mainland).""}, {'ForeName': ""Li'an"", 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Colorectal Surgery, Yuyao People's Hospital of Zhejiang Province, Zhejiang, Yuyao, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.918228']
539,31188734,Cardiovascular Morbidity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Patients with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.,"PURPOSE


Androgen deprivation therapy may increase the risk of cardiovascular disease. Limited data suggest that GnRH (gonadotropin-releasing hormone) antagonist may be associated with a lower risk of cardiovascular disease than GnRH agonist.
MATERIALS AND METHODS


We performed a phase II, randomized, open label study in men with prostate cancer and preexisting cardiovascular disease who were randomized to receive GnRH agonists or antagonists for 1 year. The primary outcome was endothelial function measured by the EndoPAT 2000 device (Itamar Medical, Caesarea, Israel). The predefined secondary outcome was a new cardiovascular event. Patients were followed for the development of cardiovascular disease, defined as death, myocardial infarction, a cerebrovascular event, percutaneous angioplasty with coronary stent insertion or hospitalizations due to cardiac events.
RESULTS


A total of 80 patients were enrolled in study, including 41 and 39 who received GnRH antagonist and agonist, respectively. Patients in each arm had similar baseline characteristics. We did not detect a difference in the primary end point (endothelial function) between the groups (mean ± SD reactive hyperemia index 2.07 ± 0.15 vs 1.92 ± 0.11, p=0.42). However, during the trial period a new cardiovascular event (the secondary end point) developed in 15 patients. Of cases new major cardiovascular and cerebrovascular events developed in 9, including death in 2, myocardial infarction in 1, a cerebrovascular event in 2 and percutaneous angioplasty with coronary stent insertion in 4. Of the patients 20% randomized to GnRH agonist experienced a major cardiovascular and cerebrovascular event compared to 3% of those on GnRH antagonist (p=0.013). The absolute risk reduction in major cardiovascular and cerebrovascular events at 12 months using GnRH antagonist was 18.1% (95% CI 4.6-31.2, p=0.032).
CONCLUSIONS


To our knowledge this is the first prospective study to test cardiovascular outcomes among patients with prostate cancer who received androgen deprivation therapy. No differences in the primary end point were noted between the study arms. However, the secondary end point revealed that patients treated with GnRH agonist experienced significantly more major cardiovascular and cerebrovascular events than those treated with GnRH antagonist. These phase II results suggest that in patients with prostate cancer who have preexisting cardiovascular disease selecting the androgen deprivation therapy modality may differentially affect cardiac outcomes.",2019,Twenty percent of patients randomized to GnRH-agonist had a MACCE compared to 3% antagonists (p=0.013).,"['patients with advanced prostate-cancer and pre-existing cardiovascular disease', 'Eighty patients were enrolled (41 GnRH-antagonist, 39 GnRH-agonist', 'men with prostate-cancer and pre-existing CVD randomized to receive', 'prostate-cancer patients receiving ADT']","['GnRH-agonists or antagonists for one year', 'MACCE', 'GnRH-agonist and GnRH-antagonist', 'Androgen-deprivation therapy (ADT']","['new incident of cardiovascular-event', 'endothelial function', 'cardiovascular-disease (CVD', 'absolute risk reduction for MACCE', 'death, myocardial infarction (MI), cerebrovascular-event (CVA), or percutaneous-angioplasty with coronary stent-insertion (PCA) or hospitalizations due to cardiac-events', 'endothelial-function', 'Cardiovascular morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0411287', 'cui_str': 'Percutaneous transluminal balloon angioplasty (procedure)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}]",80.0,0.127051,Twenty percent of patients randomized to GnRH-agonist had a MACCE compared to 3% antagonists (p=0.013).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Department of Oncology, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shavit-Grievink', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Tzlil', 'Initials': 'T', 'LastName': 'Tabachnik', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Sela', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Witberg', 'Affiliation': 'Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Wilhelmina C M', 'Initials': 'WCM', 'LastName': 'Duivenvoorden', 'Affiliation': 'Division of Urology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Davidoff Cancer Centre, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jehonathan H', 'Initials': 'JH', 'LastName': 'Pinthus', 'Affiliation': 'Division of Urology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000000384']
540,31961446,A trial-based cost-effectiveness analysis of topical 5-fluorouracil vs. imiquimod vs. ingenol mebutate vs. methyl aminolaevulinate conventional photodynamic therapy for the treatment of actinic keratosis in the head and neck area performed in the Netherlands.,"BACKGROUND


Actinic keratosis (AK) is a common premalignant skin condition that might have the ability to progress into squamous cell carcinoma. Due to the high incidence of AK, treatment of this disease significantly impacts healthcare spending.
OBJECTIVES


To determine which commonly prescribed field-directed treatment is the most cost-effective, when comparing 5-fluorouracil (5-FU) 5%, imiquimod (IMQ) 5%, ingenol mebutate (IM) 0·015% and methyl aminolaevulinate photodynamic therapy (MAL-PDT) for AK in the head and neck region.
METHODS


We performed an economic evaluation from a healthcare perspective. Data were collected alongside a single-blinded, prospective, multicentre randomized controlled trial with 624 participants in the Netherlands. The outcome measure was expressed as the incremental cost-effectiveness ratio, which is the incremental costs per additional patient with ≥ 75% lesion reduction compared with baseline. This trial was registered at ClinicalTrials.gov, number NCT02281682.
RESULTS


The trial showed that 5-FU was the most effective field treatment for AK in the head and neck region. Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433) than the €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively. The results showed that 5-FU was a dominant cost-effective treatment (more effective and less expensive) compared with the other treatments, 12 months post-treatment.
CONCLUSIONS


Based on these results, we consider 5-FU 5% cream as the first-choice treatment option for multiple AKs in the head and neck area. What's already known about this topic? Due to the increasing incidence of actinic keratosis (AK), the recommended treatment results in a considerable socioeconomic burden for (dermatological) healthcare. Although cost-effectiveness modelling studies have been performed in which different treatments for AK were compared, a prospective clinical trial comparing four frequently prescribed treatments on effectiveness and resource consumption within a time horizon of 12 months has never been conducted. What does this study add? This is the first study examining the cost-effectiveness of 5-fluorouracil 5% cream, imiquimod 5% cream, ingenol mebutate 0·015% gel and methyl aminolaevulinate photodynamic therapy, with data collected in a randomized controlled trial over a time horizon of 12 months. We found that 5-fluorouracil was a dominant cost-effective treatment (more effective and less costly), based on data from the Netherlands. Linked Comment: Steeb et al. Br J Dermatol 2020; 183:612.",2020,"Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433), compared to €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively.","['actinic keratosis in the head and neck area performed in the Netherlands', '624 participants in the Netherlands', 'Actinic keratosis (AK']","['5-FU', 'topical 5-fluorouracil vs imiquimod vs ingenol mebutate vs methylaminolevulinate conventional photodynamic therapy', '5-FU cream', '5-fluorouracil (5-FU), 5% imiquimod (IMQ), 0.015% ingenol mebutate (IM), and methylaminolevulinate photodynamic therapy (MAL-PDT']","['incremental cost-effectiveness ratio (ICER), which is the incremental costs per additional patient with ≥75% lesion reduction', 'total mean costs for 5-FU']","[{'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C4517396', 'cui_str': 'Zero point zero one five'}, {'cui': 'C0044588', 'cui_str': 'PDT'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]",624.0,0.0451631,"Twelve months post-treatment, the total mean costs for 5-FU were significantly lower (€433), compared to €728, €775 and €1621 for IMQ, IM and MAL-PDT, respectively.","[{'ForeName': 'M H E', 'Initials': 'MHE', 'LastName': 'Jansen', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'J P H M', 'Initials': 'JPHM', 'LastName': 'Kessels', 'Affiliation': 'Department of Dermatology, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Merks', 'Affiliation': 'Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'N W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Centre+, Maastricht, the Netherlands.'}, {'ForeName': 'B A B', 'Initials': 'BAB', 'LastName': 'Essers', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.18884']
541,31949084,"No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes.","OBJECTIVE


Dual incretin receptor agonists in clinical development have shown reductions in body weight and hemoglobin A 1c  (HbA 1c ) in patients with type 2 diabetes, but the impact of glucose-dependent insulinotropic polypeptide (GIP) receptor activation remains unclear. Here, we evaluated the effects of high-dose exogenous GIP on energy intake, energy expenditure, plasma glucose, and glucose-regulating hormones in patients with type 2 diabetes treated with a long-acting glucagon-like peptide 1 receptor (GLP-1R) agonist.
RESEARCH DESIGN AND METHODS


In a randomized, double-blind design, men with type 2 diabetes ( n  = 22, mean ± SEM HbA 1c  6.8 ± 0.1% [51 ± 1.5 mmol/mol]) treated with metformin and long-acting GLP-1R agonists were subjected to two 5-h continuous infusions (separated by a washout period of ≥3 days): one with GIP (6 pmol/kg/min) and another with saline (placebo). After 60 min of infusion, a liquid mixed-meal test was performed, and after 270 min of infusion, an ad libitum meal was served for evaluation of energy intake (primary end point).
RESULTS


Energy intake was similar during GIP and placebo infusion (648 ± 74 kcal vs. 594 ± 55 kcal, respectively;  P  = 0.480), as were appetite measures and energy expenditure. Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P  = 0.026 and  P  = 0.017) as assessed by area under the curve.
CONCLUSIONS


In patients with type 2 diabetes, GIP infusion on top of treatment with metformin and a long-acting GLP-1R agonist did not affect energy intake, appetite, or energy expenditure but increased plasma glucose compared with placebo. These results indicate no acute beneficial effects of combining GIP and GLP-1.",2020,"Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P  = 0.026 and  P  = 0.017) as assessed by area under the curve.
","['Men', 'patients with type 2 diabetes treated with a long-acting glucagon-like peptide 1 receptor (GLP-1R) agonist', 'patients with type 2 diabetes, GIP infusion on top of treatment with', 'patients with type 2 diabetes', 'men with type 2 diabetes ( n  = 22, mean ± SEM HbA 1c  6.8 ± 0.1% [51 ± 1.5 mmol/mol]) treated with']","['placebo', 'metformin and long-acting GLP-1R agonists', 'GIP (6 pmol/kg/min) and another with saline (placebo', 'high-dose exogenous GIP', 'Exogenous Glucose-Dependent Insulinotropic Polypeptide', 'metformin']","['energy intake, appetite, or energy expenditure but increased plasma glucose', 'body weight and hemoglobin', 'energy intake, energy expenditure, plasma glucose, and glucose-regulating hormones', 'Plasma glucagon and glucose', 'Energy Intake, Appetite, or Energy Expenditure', 'appetite measures and energy expenditure']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",594.0,0.136426,"Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P  = 0.026 and  P  = 0.017) as assessed by area under the curve.
","[{'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Heimbürger', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Liva S L', 'Initials': 'LSL', 'LastName': 'Krogh', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Xlab, Center for Healthy Ageing, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Jessen', 'Affiliation': 'Zealand Pharma A/S, Glostrup, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark filip.krag.knop.01@regionh.dk.'}]",Diabetes care,['10.2337/dc19-0578']
542,31948926,Development and validation of parsimonious algorithms to classify acute respiratory distress syndrome phenotypes: a secondary analysis of randomised controlled trials.,"BACKGROUND


Using latent class analysis (LCA) in five randomised controlled trial (RCT) cohorts, two distinct phenotypes of acute respiratory distress syndrome (ARDS) have been identified: hypoinflammatory and hyperinflammatory. The phenotypes are associated with differential outcomes and treatment response. The objective of this study was to develop parsimonious models for phenotype identification that could be accurate and feasible to use in the clinical setting.
METHODS


In this retrospective study, three RCT cohorts from the National Lung, Heart, and Blood Institute ARDS Network (ARMA, ALVEOLI, and FACTT) were used as the derivation dataset (n=2022), from which the machine learning and logistic regression classifer models were derived, and a fourth (SAILS; n=715) from the same network was used as the validation test set. LCA-derived phenotypes in all of these cohorts served as the reference standard. Machine-learning algorithms (random forest, bootstrapped aggregating, and least absolute shrinkage and selection operator) were used to select a maximum of six important classifier variables, which were then used to develop nested logistic regression models. Only cases with complete biomarker data in the derivation dataset were used for variable selection. The best logistic regression models based on parsimony and predictive accuracy were then evaluated in the validation test set. Finally, the models' prognostic validity was tested in two external ARDS clinical trial datasets (START and HARP-2) by assessing mortality at days 28, 60, and 90 and ventilator-free days to day 28.
FINDINGS


The six most important classifier variables were interleukin (IL)-8, IL-6, protein C, soluble tumour necrosis factor receptor 1, bicarbonate, and vasopressor use. From the nested models, three-variable (IL-8, bicarbonate, and protein C) and four-variable (3-variable plus vasopressor use) models were adjudicated to be the best performing. In the validation test set, both models showed good accuracy (AUC 0·94 [95% CI 0·92-0·95] for the three-variable model and 0·95 [95% CI 0·93-0·96] for the four-variable model) against LCA classifications. As with LCA-derived phenotypes, the hyperinflammatory phenotype as identified by the classifier model was associated with higher mortality at day 90 (87 [39%] of 223 patients vs 112 [23%] of 492 patients; p<0·0001) and fewer ventilator-free days (median 14 days [IQR 0-22] vs 22 days [0-25]; p<0·0001). In the external validation datasets, three-variable models developed in the derivation dataset identified two phenotypes with distinct clinical features and outcomes consistent with previous findings, including differential survival with simvastatin versus placebo in HARP-2 (p=0·023 for survival at 28 days).
INTERPRETATION


ARDS phenotypes can be accurately identified with parsimonious classifier models using three or four variables. Pending the development of real-time testing for key biomarkers and prospective validation, these models could facilitate identification of ARDS phenotypes to enable their application in clinical trials and practice.
FUNDING


National Institutes of Health.",2020,"In the validation test set, both models showed good accuracy (AUC 0·94 [95% CI 0·92-0·95] for the three-variable model and 0·95","['acute respiratory distress syndrome (ARDS', 'classify acute respiratory distress syndrome phenotypes']",['simvastatin versus placebo'],"['higher mortality', 'interleukin (IL)-8, IL-6, protein C, soluble tumour necrosis factor receptor 1, bicarbonate, and vasopressor use']","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",492.0,0.0742616,"In the validation test set, both models showed good accuracy (AUC 0·94 [95% CI 0·92-0·95] for the three-variable model and 0·95","[{'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Sinha', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Anesthesia, University of California, San Francisco, San Francisco, CA, USA. Electronic address: pratik.sinha@ucsf.edu.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""The Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK; Regional Intensive Care Unit, The Royal Hospitals, Belfast, UK.""}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': ""O'Kane"", 'Affiliation': ""The Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Anesthesia, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Anesthesia, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30369-8']
543,31588504,The Risks of Cardiovascular Disease and Mortality Following Weight Change in Adults with Diabetes: Results from ADVANCE.,"CONTEXT


Weight loss is strongly recommended for overweight and obese adults with type 2 diabetes. Unintentional weight loss is associated with increased risk of all-cause mortality, but few studies have examined its association with cardiovascular outcomes in patients with diabetes.
OBJECTIVE


To evaluate 2-year weight change and subsequent risk of cardiovascular events and mortality in established type 2 diabetes.
DESIGN AND SETTING


The Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation was an international, multisite 2×2 factorial trial of intensive glucose control and blood pressure control. We examined 5 categories of 2-year weight change: >10% loss, 4% to 10% loss, stable (±<4%), 4% to 10% gain, and >10% gain. We used Cox regression with follow-up time starting at 2 years, adjusting for intervention arm, demographics, cardiovascular risk factors, and diabetes medication use from the 2-year visit.
RESULTS


Among 10 081 participants with valid weight measurements, average age was 66 years. By the 2-year examination, 4.3% had >10% weight loss, 18.4% had 4% to 10% weight loss, and 5.3% had >10% weight gain. Over the following 3 years of the trial, >10% weight loss was strongly associated with major macrovascular events (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.26-2.44), cardiovascular mortality (HR, 2.76; 95% CI, 1.87-4.09), all-cause mortality (HR, 2.79; 95% CI, 2.10-3.71), but not major microvascular events (HR, 0.91; 95% CI, 0.61-1.36), compared with stable weight. There was no evidence of effect modification by baseline body mass index, age, or type of diabetes medication.
CONCLUSIONS


In the absence of substantial lifestyle changes, weight loss may be a warning sign of poor health meriting further workup in patients with type 2 diabetes.",2020,"There was no evidence of effect modification by baseline BMI, age, or type of diabetes medication.
","['10,081 participants with valid weight measurements, average age was 66 years', 'patients with diabetes', 'Adults with Diabetes', 'patients with type 2 diabetes', 'overweight and obese adults with type 2 diabetes']",['intensive glucose control and blood pressure control'],"['Unintentional weight loss', 'cardiovascular mortality', 'cause mortality', 'major macrovascular events', 'weight loss', 'major microvascular events', '2-year weight change and subsequent risk of cardiovascular events and mortality']","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C2363736', 'cui_str': 'Involuntary weight loss'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0634737,"There was no evidence of effect modification by baseline BMI, age, or type of diabetes medication.
","[{'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The G eorge Institute for Global Health, Sydney 2042, Australia.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Warren', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'A Richey', 'Initials': 'AR', 'LastName': 'Sharrett', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Fondation Opthalmologique Adolphe de Rothschild, Université Denis Diderot, 75019 Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hamet', 'Affiliation': ""Center de Rechercher, Center Hospitalier de l'Université de Montréal (CRCHUM), Montréal, Québec H2X 0A9, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, Royal Melbourne Hospital, University of Melbourne, Victoria 3010, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Mcevoy', 'Affiliation': 'School of Medicine, National University of Ireland, Galway Campus, and National Institute for Preventive Cardiology, Galway, H91 TK33, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The G eorge Institute for Global Health, Sydney 2042, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology and Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz045']
544,31939351,Erectile function after WST11 vascular-targeted photodynamic therapy for low-risk prostate cancer treatment.,"Vascular-targeted photodynamic therapy (VTP) using padeliporfin is currently assessed as a low-risk prostate cancer (LRPCa) treatment. The aim of this study was to assess erectile function outcomes of VTP for LRPCa treatment. We prospectively included all patients treated with VTP for LRPCa. The primary endpoint was the post-treatment International Index of Erectile Function score (IIEF5 score) evolution (at 6 months, 12 months, and then every year for 5 years). Secondary endpoints were the need of erectile dysfunction (ED) treatment and its efficacy. Eighty-two men were included. The median follow-up was 68 (range: 6-89) months. There was a 3-point significant decrease in the median IIEF5 score between baseline and at 6 months post-VTP (23 [range: 1-25] vs 20 [range: 1-25], P = 0.005). There was a 1-point decrease at 1 year and 2 years post-VTP compared to baseline (22 [range: 2-25] and 22 [range: 0-25], P < 0.005). There was no significant difference at 3, 4, and 5 years compared to baseline. Twenty-seven (32.9%) patients received ED treatment: phosphodiesterase type-5 inhibitors (PDEI5; n = 18), intracavernous injections (ICI; n = 9), and intra-urethral gel (n = 1). The median IIEF5 score statistically significantly increased after ED treatment (7 [range: 0-24] vs 21 [range: 1-25], P < 0.001). ED treatment was efficient for 75% of the patients. There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443). Forty-six patients were totally potent before VTP and among them, 13 needed ED treatment post-VTP with a success rate of 69.2%. VTP induced minimal changes in erectile function with a 3-point and a 1-point reduction in the IIEF5 score at 6 months and at 1 year, respectively. When required, ED treatment was efficient.",2020,There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443).,"['low-risk prostate cancer treatment', 'Twenty-seven (32.9%) patients received ED treatment: phosphodiesterase type-5 inhibitors (PDEI5; n = 18', 'Eighty-two men were included']","['VTP', 'intracavernous injections (ICI; n = 9), and intra-urethral gel', 'Vascular-targeted photodynamic therapy (VTP) using padeliporfin', 'VTP for LRPCa', 'WST11 vascular-targeted photodynamic therapy']","['Erectile function', 'median IIEF5 score', 'post-treatment International Index of Erectile Function score (IIEF5 score) evolution', 'need of erectile dysfunction (ED) treatment and its efficacy', 'IIEF5 score', 'erectile function']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1160729', 'cui_str': 'Conventional release urethral gel (dose form)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C2698706', 'cui_str': 'padeliporfin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score (observable entity)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]",82.0,0.0490941,There was no statistically significant difference between IIEF5 score at baseline and after ED treatment (P = 0.443).,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Chelly', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Maulaz', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bigot', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Abdel Rahmene', 'Initials': 'AR', 'LastName': 'Azzouzi', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}, {'ForeName': 'Souhil', 'Initials': 'S', 'LastName': 'Lebdai', 'Affiliation': 'Department of Urology, Angers University Hospital, Angers 49100, France.'}]",Asian journal of andrology,['10.4103/aja.aja_138_19']
545,31155764,Dietitians' Evaluation of Clearing Luminal Occlusions of Gunk (DECLOG): A Pilot Feasibility Study.,"BACKGROUND


Tube clogging is the most frequent mechanical complication associated with enteral nutrition. The objective of this study was to assess the efficacy of a protocol incorporating prophylactic use of a declogging system with enhanced patient education and monitoring to proactively reduce the incidence of tube occlusions in the home care setting.
METHODS


A convenient sample of patients discharged from hospital to home enteral nutrition (HEN) was screened for eligibility and randomized to control group (standard care) or study group (standard care with prophylactic protocol and monitoring). Study patients received 4 enzyme declogging kits before discharge and were instructed to administer them every 7 days for 4 weeks.
RESULTS


Seventeen of 49 (35%) patients reported tube occlusions. The incidence of tube occlusion in the control group was not statistically different than in the study group (29% vs 39%, P = 0.44). There was no difference between the 2 groups for negative tube outcomes, such as tube occlusion (P = 0.44), emergency department visit (P = 0.24), tube replacement (P = 0.99), or hospital readmission (P = 0.33). Continuous feeding method (P = 0.037), small-bowel feeding tubes (P = 0.016), and tube diameter <14 French (P = 0.069) were associated with tube occlusions.
CONCLUSION


A prophylactic protocol using an enzyme declogging system did not lessen the likelihood of tube occlusions when compared with standard care. Multiple factors are associated with tube occlusion. More research investigating the use of a declogging system to prevent clogging incidence in patients receiving HEN is warranted.",2020,"Continuous feeding method (P = 0.037), small-bowel feeding tubes (P = 0.016), and tube diameter <14 French (P = 0.069) were associated with tube occlusions.
","[""Dietitians' Evaluation of Clearing Luminal Occlusions of Gunk (DECLOG"", 'patients discharged from hospital to home enteral nutrition (HEN']",[],"['hospital readmission', 'likelihood of tube occlusions', 'emergency department visit', 'tube replacement', 'tube occlusions', 'negative tube outcomes, such as tube occlusion', 'small-bowel feeding tubes', 'incidence of tube occlusion']","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube, device (physical object)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.036768,"Continuous feeding method (P = 0.037), small-bowel feeding tubes (P = 0.016), and tube diameter <14 French (P = 0.069) were associated with tube occlusions.
","[{'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Escuro', 'Affiliation': 'Center for Human Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Berri', 'Initials': 'B', 'LastName': 'Burns', 'Affiliation': 'Cleveland Clinic Center for Connected Care, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McLaughlin', 'Affiliation': 'Center for Human Nutrition, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Lopez', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Cresci', 'Affiliation': 'Pediatric Gastroenterology, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10318']
546,31960624,"A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.","Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo-controlled, single-ascending-dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Participants were assigned to 1 of 3 tezepelumab dose cohorts (35, 105, or 280 mg; n = 8 per cohort) and randomized (6:2) to receive a single subcutaneous dose of tezepelumab or placebo, with a follow-up period of 84 to 112 days. The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups. Tezepelumab was absorbed slowly, reaching a maximum serum concentration (mean, 5.2-39.7 µg/mL) after 7 to 10 days. Area under the concentration-time curve (mean, 207.2-1612.0 µg · day /mL) increased in an approximate dose-proportional manner. Tezepelumab had a long terminal serum half-life (mean, 23.9-26.3 days) and a small apparent distribution volume, suggesting limited distribution into peripheral tissues. No participants developed anti-tezepelumab antibodies. Single-dose, subcutaneous administration of tezepelumab 35 to 280 mg resulted in an acceptable safety profile with linear pharmacokinetics in healthy Japanese men. No clear differences in tezepelumab safety and pharmacokinetics between Japanese and non-Japanese populations were identified.",2020,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"['healthy Japanese men', 'Healthy Japanese Men']","['Placebo', 'Tezepelumab', 'tezepelumab', 'tezepelumab or placebo', 'placebo', 'Subcutaneous Tezepelumab', 'subcutaneous tezepelumab']","['overall incidences and severities of treatment-emergent adverse events', 'anti-tezepelumab antibodies', 'tezepelumab safety and pharmacokinetics', 'Safety, Tolerability, Pharmacokinetics, and Immunogenicity', 'maximum serum concentration', 'concentration-time curve', 'safety, tolerability, pharmacokinetics, and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.196404,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Matsuki', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacology, Division of Clinical Pharmacology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Quantitative Clinical Pharmacology, AstraZeneca, Gaithersburg, Maryland, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.775']
547,31950977,Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial.,"Importance


Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown.
Objective


To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis.
Design, Setting, and Participants


Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital.
Interventions


Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs).
Main Outcomes and Measures


The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay.
Results


Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group.
Conclusions and Relevance


Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.
Trial Registration


anzctr.org.au Identifier: ACTRN12616000481471.",2020,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"['50 ICUs in 5 countries between August 2016 and January 2019', 'ICU patients requiring mechanical ventilation', 'Patients Receiving Invasive Mechanical Ventilation', 'Patients requiring invasive mechanical ventilation within 24 hours of ICU admission', 'patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU', '17.0] years; 9691 [36.1%] were women', '26\u202f982 patients who were randomized, 154 opted out, and 26\u202f828 were analyzed (mean [SD] age, 58']","['ICU', 'Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs', 'PPIs vs H2RBs', 'Proton Pump Inhibitors vs Histamine-2 Receptor Blockers', 'anzctr.org.au Identifier']","['hospital mortality rates', 'cause mortality', 'Hospital Mortality', 'Clinically important upper gastrointestinal bleeding', 'clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay', 'Rates of Clostridioides difficile infection and ICU and hospital lengths of stay']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2741638', 'cui_str': 'Stress ulcer (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.126156,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Biostatistics Unit, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Intensive Care Unit, Freeman Hospital, Newcastle upon Tyne, England.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Brickell', 'Affiliation': ""University College Dublin-Clinical Research Centre, St Vincent's Hospital, Dublin, Ireland.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Intensive Care Unit, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Intensive Care Unit, Canberra Hospital, Canberra, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Leanlove', 'Initials': 'L', 'LastName': 'Navarra', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Opgenorth', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pilcher', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Saxena', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}]",JAMA,['10.1001/jama.2019.22190']
548,31486723,Population-Based Pragmatic Trial of Advance Care Planning in Primary Care in the University of California Health System.,"Introduction:  Varying intensity of advance care planning (ACP) interventions at the population level has not been compared among seriously ill patients in primary care. This project will implement, test, and disseminate real-world scalable ACP interventions among primary care clinics across three University of California Health systems. The three ACP interventions are (1) distribution of an advance directive (AD) with targeted ACP messaging, (2) the AD, messaging, plus prompting patients to engage with the  Prepare For Your Care  website (PREPARE), and (3) the AD, messaging, PREPARE, plus Care Coordinator engagement with patients and clinicians.  Methods:  We will identify a population cohort of seriously ill primary care patients and implement the ACP interventions using electronic health record (EHR) patient portals and postal mailings. Forty-five clinics across the three health systems will be cluster randomized to one of the three ACP interventions. The primary outcome for the population cohort is AD or Physician Orders for Life-Sustaining Treatment documentation in the EHR. A subset of the population cohort will be surveyed to assess patient-centered outcomes, including care consistent with goals at baseline, 12 months, and 24 months. Caregivers will be interviewed if patients are unable to be surveyed or die. ACP documentation, goal concordant care, and among decedents, health care utilization will be compared among intervention arms.  Study Implementation: Challenges and Contributions:  The project is guided by a Study Advisory Group and Community Advisory Groups at each site to ensure rigorous patient-centered methods and consistency of implementation. Intervention fidelity will be evaluated using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework. Challenges to implementation of this three-site health system trial and to intervention fidelity stem from site/clinic/system cultures, increasing attention to end-of-life care from payers and regulators, and growing pressures by health systems to implement ACP interventions. Stakeholder engagement is required to ensure consistent interventions across sites.",2019,"Intervention fidelity will be evaluated using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework.","['Primary Care in the University of California Health System', 'primary care clinics across three University of California Health systems', 'population cohort of seriously ill primary care patients and implement the ACP interventions using electronic health record (EHR) patient portals and postal mailings', 'seriously ill patients in primary care', 'Forty-five clinics across the three health systems']","['Advance Care Planning', 'advance directive (AD) with targeted ACP messaging, (2) the AD, messaging, plus prompting patients to engage with the  Prepare For Your Care  website (PREPARE), and (3) the AD, messaging, PREPARE, plus Care Coordinator engagement with patients and clinicians', 'advance care planning (ACP) interventions']",['AD or Physician Orders for Life-Sustaining Treatment documentation in the EHR'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",45.0,0.074042,"Intervention fidelity will be evaluated using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework.","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Walling', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Ron D', 'Initials': 'RD', 'LastName': 'Hays', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gibbs', 'Affiliation': 'Departments of Medicine and Family Medicine, University of California, Irvine, California.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Departments of Medicine and Family Medicine, University of California, Irvine, California.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanz', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Wenger', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, California.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0142']
549,31914811,First-line trifluridine/tipiracil plus bevacizumab for unresectable metastatic colorectal cancer: SOLSTICE study design.,"Trifluridine/tipiracil (TT) is an orally administered combination of the thymidine-based nucleoside analogue trifluridine and the thymidine phosphorylase inhibitor tipiracil hydrochloride, which increases the bioavailability of cytotoxic trifluridine. Encouraging antitumor activity of first-line TT + bevacizumab (TT-B) has been observed in a Phase II study in patients with unresectable metastatic colorectal cancer ineligible for combination oxaliplatin- or irinotecan-based therapy. Here, we describe the design of SOLSTICE (NCT03869892), an open-label, Phase III trial in unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. The 854 patients were randomized 1:1 to receive first-line TT-B versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression-free survival with TT-B over capecitabine + bevacizumab. The first patient was enrolled in March 2019.",2020,Encouraging antitumor activity of first-line TT + bevacizumab (TT-B) has been observed in a Phase II study in patients with unresectable metastatic colorectal cancer ineligible for combination oxaliplatin- or irinotecan-based therapy.,"['patients with unresectable metastatic colorectal cancer ineligible for combination', '854 patients', 'unresectable metastatic colorectal cancer', 'unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy']","['bevacizumab (TT-B', 'Trifluridine/tipiracil (TT', 'trifluridine/tipiracil plus bevacizumab', 'oxaliplatin- or irinotecan-based therapy', 'capecitabine\xa0+\xa0bevacizumab', 'TT-B over capecitabine + bevacizumab']","['superior progression-free survival', 'bioavailability of cytotoxic trifluridine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}]",854.0,0.0276214,Encouraging antitumor activity of first-line TT + bevacizumab (TT-B) has been observed in a Phase II study in patients with unresectable metastatic colorectal cancer ineligible for combination oxaliplatin- or irinotecan-based therapy.,"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université & Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kanehisa', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gandossi', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Fougeray', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadia Causse', 'Initials': 'NC', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Pisa, Italy.'}]","Future oncology (London, England)",['10.2217/fon-2019-0786']
550,31523904,Evaluation of the effects of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial.,"BACKGROUND


The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium-glucose co-transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large-scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF.
STUDY DESIGN


The EMPEROR-Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co-morbidities.
STUDY AIMS


The primary endpoint is the time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.",2019,"The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.","['patients with type\u20092 diabetes', 'patients with chronic heart failure and a preserved ejection fraction', '≈5750 patients with HFpEF']","['placebo or empagliflozin', 'sodium-glucose co-transporter 2 inhibition with empagliflozin', 'empagliflozin']","['time-to-first-event analysis of the combined risk for cardiovascular death or hospitalization for heart failure', 'morbidity and mortality', 'renal function, cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0591386,"The EMPEROR-Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.","[{'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Centre for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Boehringer Ingelheim Canada Ltd, Burlington, ON, Canada.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm INI-CRCT, CHRU, University of Lorraine, Nancy, France.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1596']
551,31436325,Early MRI predictors of disease-free survival in locally advanced rectal cancer from the GRECCAR 4 trial.,"BACKGROUND


Tailored neoadjuvant treatment of locally advanced rectal cancer (LARC) may improve outcomes. The aim of this study was to determine early MRI prognostic parameters with which to stratify neoadjuvant treatment in patients with LARC.
METHODS


All patients from a prospective, phase II, multicentre randomized study (GRECCAR4; NCT01333709) were included, and underwent rectal MRI before treatment, 4 weeks after induction chemotherapy and after completion of chemoradiotherapy (CRT). Tumour volumetry, MRI tumour regression grade (mrTRG), T and N categories, circumferential resection margin (CRM) status and extramural vascular invasion identified by MRI (mrEMVI) were evaluated.
RESULTS


A total of 133 randomized patients were analysed. Median follow-up was 41·4 (95 per cent c.i. 36·6 to 45·2) months. Thirty-one patients (23·3 per cent) developed tumour recurrence. In univariable analysis, mrEMVI at baseline was the only prognostic factor associated with poorer outcome (P = 0·015). After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome. After completion of CRT, the absence of complete response on MRI (P = 0·004), mrEMVI (P = 0·038) and a poor mrTRG (P = 0·005) were associated with shorter disease-free survival. A final multivariable model including all significant variables (baseline, after induction, after CRT) revealed that Eastern Cooperative Oncology Group performance status (P = 0·011), sphincter involvement (P = 0·009), mrEMVI at baseline (P = 0·002) and early tumour volume regression of 60 per cent or less after induction (P = 0·007) were associated with relapse.
CONCLUSION


Baseline and early post-treatment MRI parameters are associated with prognosis in LARC. Future preoperative treatment should stratify treatment according to baseline mrEMVI status and early tumour volume regression.",2019,"After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome.","['A total of 133 randomized patients were analysed', 'patients with LARC', 'locally advanced rectal cancer', 'locally advanced rectal cancer (LARC']",['induction chemotherapy and after completion of chemoradiotherapy (CRT'],"['tumour recurrence', 'Tumour volumetry, MRI tumour regression grade (mrTRG), T and N categories, circumferential resection margin (CRM) status and extramural vascular invasion identified by MRI (mrEMVI', 'early MRI prognostic parameters', 'sphincter involvement', 'shorter disease-free survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0436188', 'cui_str': 'Volumetry (procedure)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",133.0,0.0702971,"After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nougaret', 'Affiliation': 'Department of Radiology, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Castan', 'Affiliation': 'Biometrics Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Forges', 'Affiliation': 'Clinical Research Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gallix', 'Affiliation': 'Department of Radiology, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gourgou', 'Affiliation': 'Biometrics Unit, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': 'Department of Surgical Oncology, Institut du Cancer de Montpellier, University of Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11233']
552,31618060,Perfusion of Intrapulmonary Arteriovenous Anastomoses Is Not Related to VO 2max  in Hypoxia and Is Unchanged by Oral Sildenafil.,"Background:  Perfusion of intrapulmonary arteriovenous anastomoses (IPAVA) is increased during exercise and in hypoxia and is associated with variations in oxygen saturation (S P O 2 ), resulting in blood bypassing the pulmonary microcirculation. Sildenafil is a pulmonary vasodilator that improves S P O 2  and endurance performance in hypoxia. The purpose of this study was to determine if 50 mg sildenafil would reduce IPAVA perfusion (Q IPAVA ) and if the decrement in maximal exercise capacity (VO 2max ) in hypoxia is related to Q IPAVA . We hypothesized that during progressive levels of hypoxia at rest (F I O 2  = 0.21, 0.14, 0.12), sildenafil would increase S P O 2  and reduce bubble score (estimate of Q IPAVA ) compared to placebo, and that the decrement in VO 2max  in hypoxia would be positively correlated with bubble score at rest in hypoxia.  Materials and Methods:  Fourteen endurance-trained men performed a graded maximal exercise test at sea level and at a simulated altitude of 3000 m, followed by two experimental visits where, after randomly ingesting sildenafil or placebo, they underwent agitated saline contrast echocardiography during progressive levels of hypoxia at rest.  Results:  All participants experienced a decrement in power output in hypoxia that ranged from 9% to 19% lower than sea level values. Compared to normoxia, bubble score increased significantly in hypoxia ( p  < 0.001) with no effect of sildenafil ( p  = 0.580). There was a negative correlation between S P O 2  and bubble score ( p  < 0.001). The decrement in peak power output at VO 2max  in hypoxia was unrelated to IPAVA perfusion in resting hypoxia ( p  = 0.32). Several participants demonstrated Q IPAVA  greater than zero in room air, indicating that arterial hypoxemia may not be the sole mechanism for Q IPAVA .  Conclusion:  These results indicate that the VO 2max  decrement caused by hypoxia is not related to Q IPAVA  and that sildenafil does not improve VO 2max  in hypoxia through modulation of Q IPAVA .",2019,All participants experienced a decrement in power output in hypoxia that ranged from 9% to 19% lower than sea level values.,['Fourteen endurance-trained men'],"['graded maximal exercise test at sea level', 'sildenafil or placebo', 'sildenafil', 'agitated saline contrast echocardiography', 'placebo', 'Sildenafil', 'intrapulmonary arteriovenous anastomoses (IPAVA']","['maximal exercise capacity (VO 2max ', 'progressive levels of hypoxia at rest', 'power output in hypoxia', 'IPAVA perfusion (Q IPAVA ', 'VO 2max', 'VO 2max  in hypoxia', 'hypoxia', 'peak power output at VO 2max  in hypoxia']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0013518', 'cui_str': 'Echocardiography, Contrast'}, {'cui': 'C0442121', 'cui_str': 'Intrapulmonary (qualifier value)'}, {'cui': 'C0225984', 'cui_str': 'Arteriovenous Anastomosis'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",14.0,0.0677507,All participants experienced a decrement in power output in hypoxia that ranged from 9% to 19% lower than sea level values.,"[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Carter', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': ""O'Donovan"", 'Affiliation': 'Sports Medicine Department, Sports Surgery Clinic, Santry, Ireland.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Milsom', 'Affiliation': 'Department of Zoology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}]",High altitude medicine & biology,['10.1089/ham.2019.0051']
553,31905354,Comparison of Two Telemedicine Delivery Modes for Neonatal Resuscitation Support: A Simulation-Based Randomized Trial.,"INTRODUCTION


Previous research has described technical aspects of telemedicine and the clinical impact of provider-to-patient telemedicine; however, little is known about provider-to-provider telemedical interventions.
OBJECTIVE


The primary aim of this study was to compare two telemedicine delivery modes on the quality of a simulated neonatal resuscitation. Our secondary aim was to evaluate the providers' task load.
METHODS


This was a prospective, single-center, randomized, simulation-based trial comparing a remote neonatal team leader (""teleleader"") versus a remote consultant (""teleconsultant""). Participants resuscitated a simulated, apneic, and bradycardic neonate. Performance was assessed by video review and task load was measured by the self-reported NASA task load index (NASA-TLX) tool. In the teleleader group, one remote neonatal specialist assumed the role of team leader in the resuscitation. In the teleconsultant group, the same remote specialist assumed the role of teleconsultant.
RESULTS


Twenty-two participants were included in the analyses. The teleleader group was associated with a higher overall checklist score compared to teleconsultants (median score 68%, interquartile range [IQR]: 66-69 vs. 58%, IQR: 42-62; p = 0.016). No significant difference was seen in overall subjective workload as measured by the NASA-TLX tool. However, mental demand and frustration were significantly greater with teleconsultants compared to teleleaders (mean mental demand: 14.1 vs. 17.0 out of 21; frustration: 7.9 vs. 14.7 out of 21).
CONCLUSIONS


Simulated neonates randomized to teams with teleleaders received significantly better resuscitative care compared to those randomized to teams with teleconsultants. Mental demand and frustration were higher for providers in the teleconsultant compared to teleleader teams.",2020,"The teleleader group was associated with a higher overall checklist score compared to teleconsultants (median score 68%, interquartile range [IQR]: 66-69 vs. 58%, IQR: 42-62; p = 0.016).","['Neonatal Resuscitation Support', 'Twenty-two participants were included in the analyses', 'Participants resuscitated a simulated, apneic, and bradycardic neonate']","['remote neonatal team leader (""teleleader"") versus a remote consultant (""teleconsultant']","['overall checklist score', 'Mental demand and frustration', 'video review and task load', 'mental demand and frustration', 'overall subjective workload']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",22.0,0.0473408,"The teleleader group was associated with a higher overall checklist score compared to teleconsultants (median score 68%, interquartile range [IQR]: 66-69 vs. 58%, IQR: 42-62; p = 0.016).","[{'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Gross', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA, isabel.t.gross@gmail.com.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Whitfill', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Redmond', 'Affiliation': 'Department of Neonatology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Couturier', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Ambika', 'Initials': 'A', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Joseph', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ray', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Neonatology,['10.1159/000504853']
554,31900179,Efficacy of combination therapy with ezetimibe and statins versus a double dose of statin monotherapy in participants with hypercholesterolemia: a meta-analysis of literature.,"BACKGROUND


The aim of this study was to compare and summarize the lipid-altering effects of combination therapy with ezetimibe and statins (E/S) and a double dose of statin (D/S) monotherapy on patients with hypercholesterolemia.
METHODS


We conducted search on 2 medical databases, PubMed and EMBASE to identify all relevant studies. A meta-analysis was performed to clarify the efficacy in the two groups. Only double-blind Randomized controlled study (RCTs) of efficacy evaluation in the two groups with ezetimibe and statins and a double dose of statin in participants with hypercholesterolemia that examined low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and high-density lipoprotein (HDL) were included. Two reviewers extracted data from all primary studies independently. The primary data were the level of LDL-C, TC and HDL-C concentrations at the end point and are expressed as mean and standard deviation (SD).
RESULTS


A total of 11 double-blind, active or placebo-controlled studies with 1926 hypercholesterolemia adults randomized to ezetimibe 10 mg added to ongoing statins (N = 994) or statin titration (doubling) (N = 932) were pooled for the global meta-analysis. The effect size between treatment groups within individual studies was assessed by weighted mean difference (MD) using a random- or fixed-effect model. The result showed that the participants in E/S group get obvious lower LDL-C [MD = -13.14 mg/dL, 95%CI (-16.83, -9.44), p = 0.00001] and TC concentration [MD = -23.79 mg/dL, 95%CI (-38.65, -8.93), p = 0.002] from baseline to follow-up, comparing to the D/S group. Besides, no significant between-group differences were observed for concentrations of HDL-C [MD = 0.46 mg/dL, 95%CI (- 1.14, 2.06), p = 0.57]. According to subgroup analysis, the combination of ezetimibe and atorvastatin (10 mg) [MD = -16.98 mg/dL, p < 0 .0001] or simvastatin (20 mg) [MD = -17.35 mg/dL, p < 0 .0001] showed stronger ability of reducing LDL-C than combination of ezetimibe and rosuvastatin (10 mg) [MD = -9.29 mg/dL, p = 0.05]. The efficacy of short-term (endpoint time between 6 to 16 week) and long-term (52 week) treatment in the LDL-C between two groups did not show significant differences. Besides, only participants from Asia treated with combination therapy were associated with a significant lower LDL-C concentration [MD = -14.7 mg/dL, p < 0 .0001].
CONCLUSIONS


The addition of ezetimibe to statin appears to be more effective on reducing LDL-C and TC concentrations than doubling the statin dose. Moreover, the ability to reduce cholesterol levels of combinations therapy with ezetimibe and different statins or to participants from different geographic location may vary, based on this meta-analysis, while more samples are needed to verify.",2020,"Besides, no significant between-group differences were observed for concentrations of HDL-C [MD = 0.46 mg/dL, 95%CI (- 1.14, 2.06), p = 0.57].","['participants with hypercholesterolemia', '1926 hypercholesterolemia adults', 'patients with hypercholesterolemia', 'participants with hypercholesterolemia that examined low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and high-density lipoprotein (HDL) were included']","['simvastatin', 'ezetimibe and rosuvastatin', 'statin monotherapy', 'placebo', 'ezetimibe and atorvastatin', 'ezetimibe and statins and a double dose of statin', 'ezetimibe 10\u2009mg added to ongoing statins (N\u2009=\u2009994) or statin titration', 'ezetimibe', 'ezetimibe and statins', 'statin (D/S) monotherapy', 'ezetimibe and statins (E/S']","['LDL-C concentration', 'concentrations of HDL-C', 'stronger ability of reducing LDL-C', 'cholesterol levels', 'TC concentration', 'level of LDL-C, TC and HDL-C concentrations', 'LDL-C and TC concentrations']","[{'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1593702', 'cui_str': 'ezetimibe 10 MG [Zetia]'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",932.0,0.183804,"Besides, no significant between-group differences were observed for concentrations of HDL-C [MD = 0.46 mg/dL, 95%CI (- 1.14, 2.06), p = 0.57].","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, No.1 Friendship Road, Yuanjiagang, Yuzhong District, Chongqing, 400016, China.'}, {'ForeName': 'Chunshui', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiovascular Surgery, Xinqiao Hospital of Army Medical University, Chongqing, 400000, China.'}, {'ForeName': 'Qianran', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, No.1 Friendship Road, Yuanjiagang, Yuzhong District, Chongqing, 400016, China.'}, {'ForeName': 'Yihan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, No.1 Friendship Road, Yuanjiagang, Yuzhong District, Chongqing, 400016, China. drwangyihan@163.com.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, No.1 Friendship Road, Yuanjiagang, Yuzhong District, Chongqing, 400016, China.'}]",Lipids in health and disease,['10.1186/s12944-019-1182-5']
555,31904685,"Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.","OBJECTIVES


To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance.
DESIGN


A multicenter randomized sham-controlled clinical trial.
SETTING


Twelve ICUs in Canada.
PATIENTS


We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently.
INTERVENTIONS


Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol.
MEASUREMENTS AND MAIN RESULTS


The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
CONCLUSIONS


Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.",2020,"Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
","['Twelve ICUs in Canada', '159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group', 'critically ill patients at risk for enteral feeding intolerance', 'We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently', 'Long-Stay ICU Patients', 'critically ill patients']","['esophageal stimulation', 'esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment']","['serious adverse events', 'nutritional adequacy', 'risk of harm', 'proportion of caloric and protein prescription received enterally', 'Clinically important arrhythmias']","[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3665892', 'cui_str': 'Enteral feeding intolerance'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",159.0,0.383065,"Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006).
","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Marquis', 'Affiliation': ""CIUSSS de-l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada.""}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Department of Critical Care Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Albert', 'Affiliation': 'Centre de Recherche Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Center, Population Health and Optimal Health Practices Research Unit, (Traumatology-Emergency-Critical Care Medicine), Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Kosar A', 'Initials': 'KA', 'LastName': 'Khwaja', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Garland', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Nova Scotia Health Authority and the Department of Critical Care Medicine Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Chapman', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsiogannis', 'Affiliation': 'Department of Critical Care Medicine, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, London Health Sciences Centre & Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': 'Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, Canada.'}]",Critical care medicine,['10.1097/CCM.0000000000004176']
556,31464063,Short-term fully closed-loop insulin delivery using faster insulin aspart compared with standard insulin aspart in type 2 diabetes.,"We evaluated the efficacy and safety of short-term fully closed-loop insulin delivery using faster versus standard insulin aspart in type 2 diabetes. Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of closed-loop insulin delivery with either faster or standard insulin aspart in a double-blind randomized crossover design. Basal-bolus regimen was replaced by model predictive control algorithm-directed insulin delivery based on sensor glucose levels. The primary outcome was time with plasma glucose in target range (5.6-10.0 mmol/L) and did not differ between treatments (mean difference [95% CI] 3.3% [-8.2; 1.7], P = 0.17). Mean glucose and glucose variability were comparable, as was time spent below and above target range. Hypoglycaemia (<3.5 mmol/L) occurred once with faster insulin aspart and twice with standard insulin aspart. Mean total insulin dose was higher with faster insulin aspart (mean difference [95% CI] 3.7 U [0.7; 6.8], P = 0.021). No episodes of severe hypoglycaemia or other serious adverse events occurred. In conclusion, short-term fully closed-loop in type 2 diabetes may require higher dose of faster insulin aspart compared with standard insulin aspart to achieve comparable glucose control.",2019,Hypoglycaemia (<3.5mmol/l) occurred once with faster insulin aspart and twice with standard insulin aspart.,"['type 2 diabetes', 'Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of']","['faster insulin aspart and twice with standard insulin aspart', 'standard insulin aspart', 'short-term fully closed-loop insulin delivery using faster versus standard insulin aspart', 'closed-loop insulin delivery with either faster or standard insulin aspart', 'insulin aspart']","['severe hypoglycaemia', 'Mean total insulin dose', 'time with plasma glucose in target range', 'Hypoglycaemia', 'efficacy and safety', 'Mean glucose and glucose variability']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",15.0,0.0666606,Hypoglycaemia (<3.5mmol/l) occurred once with faster insulin aspart and twice with standard insulin aspart.,"[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Semmo', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wertli', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13861']
557,31796477,The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption.,"OBJECTIVES


Coupled Plasma Filtration and Adsorption (CPFA) use in septic shock remains controversial. The objective is to clarify whether the application of high doses of CPFA in addition to the current clinical practice could reduce hospital mortality in septic shock patients in Intensive Care Units at 28 days and at 90 days follow-up.
DESIGN


We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
SETTING


Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems). The protocol was approved by the ethics committees of all participating centres. Circumstances beyond our control produced a change in recruitment conditions unacceptable to ROMPA researchers and the trial was discontinued.
PARTICIPANTS


By closure, five centres from an initial 10 fulfilled the necessary trial criteria, with 49 patients included, 30 in the control group (CG) and 19 in the intervention group (IG).
INTERVENTION


CPFA.
MAIN OUTCOME MEASURES


Hospital mortality at 28 days and 90 days follow-up.
RESULTS


After 28 days, 14 patients died (46.7%) from the CG and 11 (57.9%) from the IG, not reaching statistical significance (p=0.444). At 90 days, 19 patients had died (63.3%) from the CG and 11 patients (57.9%) from the IG, (p=0.878). The adjustment by propensity score or the use of the Kaplan-Meier technique failed to achieve statistical difference, neither by Intention to Treat nor by the Actual Intervention Received.
CONCLUSION


We herewith present the results gained from the prematurely closed trial. The results are inconclusive due to low statistical power but we consider that this data is of interest for the scientific community and potentially necessary for any ensuing debate.
REGISTER


NCT02357433 in clinicaltrials.gov.",2019,"We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
","['septic shock patients in Intensive Care Units at 28 days and at 90 days follow-up', 'By closure, five centres from an initial 10 fulfilled the necessary trial criteria, with 49 patients included, 30 in the control group (CG) and 19 in the intervention group (IG']",['CPFA'],"['Hospital mortality', 'hospital mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.148823,"We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=0.8; n=190 (95×2)).
","[{'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Giménez-Esparza', 'Affiliation': 'Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Portillo-Requena', 'Affiliation': 'Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Alicante, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Colomina-Climent', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Allegue-Gallego', 'Affiliation': 'Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Galindo-Martínez', 'Affiliation': 'Intensive Care Unit, General University Santa Lucía Hospital of Cartagena, Cartagena, Murcia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mollà-Jiménez', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Antón-Pascual', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Mármol-Peis', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Dólera-Moreno', 'Affiliation': 'Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Serra', 'Affiliation': 'Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Valencia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Martín-Ruíz', 'Affiliation': 'Intensive Care Unit, Lluís Alcanyís Hospital of Xàtiva, Xàtiva, Valencia, Spain.'}, {'ForeName': 'Pablo Juan', 'Initials': 'PJ', 'LastName': 'Fernández-Arroyo', 'Affiliation': 'Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Alicante, Spain.'}, {'ForeName': 'Eugenia María', 'Initials': 'EM', 'LastName': 'Blasco-Císcar', 'Affiliation': 'Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Alicante, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cánovas-Robles', 'Affiliation': 'Intensive Care Unit, General University Hospital of Alicante, Alicante, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'González-Hernández', 'Affiliation': 'Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Castellón, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Sánchez-Morán', 'Affiliation': 'Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Castellón, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Solera-Suárez', 'Affiliation': 'Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Valencia, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Torres-Tortajada', 'Affiliation': 'Intensive Care Unit, Francesc de Borja Hospital of Gandía, Gandía, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain antonio.pb23@gmail.com.'}, {'ForeName': 'Vicente F', 'Initials': 'VF', 'LastName': 'Gil-Guillen', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-030139']
558,31535359,The Therapeutic Effect of Intravesical Instillation of Platelet Rich Plasma on Recurrent Bacterial Cystitis in Women: A Randomized Clinical Trial.,"PURPOSE


Recurrent bacterial cystitis is a common infection in women and there are concerns about its antibiotic therapy. Platelet rich plasma has antimicrobial and tissue repairing effects. We investigated the effect of platelet rich plasma as an intravesical therapy to prevent recurrence of bacterial cystitis.
MATERIALS AND METHODS


Thirty women with a history of recurrent bacterial cystitis were randomly assigned into two groups: 1) platelet rich plasma and 2) control groups. The first group received 10 mL of platelet rich plasma with intravesical instillation plus 40 mL of normal saline. The control group only received 50 mL of normal saline. We did the instillation once a week for four weeks in both groups. We followed up the participants two and 12 months after the last instillation with a questionnaire (the international consultation on incontinence questionnaire in overactive bladder) and result of their urine culture.
RESULTS


A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004). Also, there was a significant improvement in the questionnaire's score two (3.6 ± 2.58 vs. 0.66 ± 1.63, P = 0.002) and 12 months (3.4 ± 2.77 vs. 0.006 ± 1.83, P < 0.001) after instillation in the platelet rich plasma group compared to control group. There was no adverse effect 12 months after instillation.
CONCLUSION


Platelet rich plasma can significantly decrease the recurrence of bacterial cystitis up to a year after instillation without any side effect.",2019,"A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004).","['recurrent bacterial cystitis in women', 'Thirty women with a history of recurrent bacterial cystitis']","['platelet rich plasma and 2) control groups', '10 mL of platelet rich plasma with intravesical instillation plus 40 mL of normal saline', 'platelet rich plasma', '50 mL of normal saline', 'Materials and Methods']","[""questionnaire's score"", 'number of bacterial cystitis recurrences', 'recurrence of bacterial cystitis']","[{'cui': 'C1959870', 'cui_str': 'Recurrent bacterial cystitis (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0742964', 'cui_str': 'Bladder infection due bacteria'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",30.0,0.0435269,"A significant decrease was observed in the number of bacterial cystitis recurrences in the platelet rich plasma group compared to the control group 12 months after the instillation (4 vs. 1, P = 0.004).","[{'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran. mirzaeimahboubeh@yahoo.com.'}, {'ForeName': 'Azar', 'Initials': 'A', 'LastName': 'Daneshpajooh', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farsinezhad', 'Affiliation': 'Cell Therapy and Regenerative Medicine Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Jafarian', 'Affiliation': 'Department of Internal Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ebadzadeh', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Saberi', 'Affiliation': 'Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Teimorian', 'Affiliation': 'Department of Urology, Kerman University of Medical Sciences, Kerman, Iran.'}]",Urology journal,['10.22037/uj.v0i0.5239']
559,31918929,Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years.,"OBJECTIVES


The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging.
BACKGROUND


Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported.
METHODS


In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT).
RESULTS


Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference -0.37 mm [95% confidence interval: -0.50 to -0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm 2  vs. 7.15 ± 2.16 mm 2 , mean difference -1.04 mm 2  [95% confidence interval: -1.66 to -0.42 mm 2 ]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention.
CONCLUSIONS


In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284).",2020,"p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT.",['400 patients'],"['AVJ-301 [Absorb™ BVS', 'Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent', 'BVS', 'cobalt-chromium everolimus-eluting stent', 'serial angiography and intravascular ultrasound or optical coherence tomography (OCT']","['positive vessel remodeling, late luminal enlargement, and restoration of vasomotion', 'OCT-based healing score', 'larger neointimal area', 'intraluminal scaffold dismantling (ISD', 'serial OCT, ISD']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]",400.0,0.121855,"p < 0.001), and larger neointimal area (2.10 ± 0.61 mm 2  vs. 1.86 ± 0.64 mm 2 , mean difference 0.24 mm 2  [95% confidence interval: 0.06 to 0.43 mm 2 ]; p = 0.01) by OCT.","[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands; Cardialysis, Rotterdam, the Netherlands.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Shiomi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Namiki', 'Affiliation': 'Kanto Rosai Hospital, Kawasaki, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Jungo', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Hanaoka Seishu Memorial Cardiovascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Keiichi Igarashi', 'Initials': 'KI', 'LastName': 'Hanaoka', 'Affiliation': 'Hanaoka Seishu Memorial Cardiovascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kitahara', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kusano', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rapoza', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, California.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Columbia University Medical Center, NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Fitzgerald', 'Affiliation': 'Stanford Cardiovascular Institute, Stanford, California.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.047']
560,31652030,"An open randomized controlled trial of the effects of linguistic simplification and mediation on the comprehension of ""easy read"" text by people with intellectual disabilities.","BACKGROUND


This trial aimed to measure the effects of extrinsic and intrinsic factors on users' comprehension of health information provided in adapted written ""easy read"" material.
METHOD


Sixty adults with intellectual disabilities undertook The Easy Read Task, randomly allocated with stratification by reading ability to one of four conditions (with and without simplified language/with and without mediation).
RESULTS


Neither linguistic complexity of the text nor mediation independently or combined made a significant difference to the understanding of information. Post hoc testing revealed that the group who received simplified language with mediation performed significantly better than the group that had complex text with mediation. None of the other differences between the remaining groups were significant.
CONCLUSIONS


Constructing meaning needs to extend beyond a consideration of form as found in ""easy read"" documents to recognize the role of individual capacity for language processing.",2020,Post hoc testing revealed that the group who received simplified language with mediation performed significantly better than the group that had complex text with mediation.,"['people with intellectual disabilities', 'Sixty adults with intellectual disabilities undertook The Easy Read Task, randomly allocated with stratification by reading ability to one of four conditions (with and without simplified language/with and without mediation']",['linguistic simplification and mediation'],[],"[{'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}]","[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}]",[],60.0,0.0527353,Post hoc testing revealed that the group who received simplified language with mediation performed significantly better than the group that had complex text with mediation.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buell', 'Affiliation': 'University of Dundee, Dundee, UK.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Langdon', 'Affiliation': 'Centre for Educational Development Appraisal and Research (CEDAR), University of Warwick, Coventry, UK.'}, {'ForeName': 'Gabrina', 'Initials': 'G', 'LastName': 'Pounds', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bunning', 'Affiliation': 'University of East Anglia, Norwich, UK.'}]",Journal of applied research in intellectual disabilities : JARID,['10.1111/jar.12666']
561,31907537,The Effect of Cigarette Packaging and Illness Sensitivity on Attention to Graphic Health Warnings: A Controlled Study.,"INTRODUCTION


The social and health care costs of smoking are immense. To reduce these costs, several tobacco control policies have been introduced (eg, graphic health warnings [GHWs] on cigarette packs). Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes. Past studies have also found that illness sensitivity (IS) protects against health-impairing behaviors. Building on this evidence, the goal of the current study was to assess the effect of packaging type (plain vs. branded), IS level, and their interaction on attention to GHWs on cigarette packages using proposed Canadian prototypes.
AIMS AND METHODS


We assessed the dwell time and fixations on the GHW component of 40 cigarette pack stimuli (20 branded; 20 plain). Stimuli were presented in random order to 50 smokers (60.8% male; mean age = 33.1; 92.2% daily smokers) using the EyeLink 1000 system. Participants were divided into low IS (n = 25) and high IS (n = 25) groups based on scores on the Illness Sensitivity Index.
RESULTS


Overall, plain packaging relative to branded packaging increased fixations (but not dwell time) on GHWs. Moreover, low IS (but not high IS) smokers showed more fixations to GHWs on plain versus branded packages.
CONCLUSIONS


These findings demonstrate that plain packaging is a promising intervention for daily smokers, particularly those low in IS, and contribute evidence in support of impending implementation of plain packaging in Canada.
IMPLICATIONS


Our findings have three important implications. First, our study provides controlled experimental evidence that plain packaging is a promising intervention for daily smokers. Second, the findings of this study contribute supportive evidence for the impending plain packaging policy in Canada, and can therefore aid in defense against anticipated challenges from the tobacco industry upon its implementation. Third, given its effects in increasing attention to GHWs, plain packaging is an intervention likely to provide smokers enhanced incentive for smoking cessation, particularly among those low in IS who may otherwise be less interested in seeking treatment for tobacco dependence.",2020,"Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes.",['50 smokers (60.8% male'],"['Cigarette Packaging and Illness Sensitivity on Attention to Graphic Health Warnings', 'packaging type (plain versus branded']",['dwell time and fixations on the GHW component of 40 cigarette pack stimuli'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0429659', 'cui_str': 'Dwell time (observable entity)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",1000.0,0.0152278,"Previous research has found plain packaging (a homogenized form of packaging), in comparison to branded packaging, effectively increases attention to GHWs using UK packaging prototypes.","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Hardardottir', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Hamdani', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Hurst', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Sherry H', 'Initials': 'SH', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology and Neuroscience, Dalhousie University, Halifax, Canada.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz243']
562,31843821,DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care.,"INTRODUCTION


Home care clients are increasingly medically complex, have limited access to effective chronic disease management and have very high emergency department (ED) visitation rates. There is a need for more appropriate and targeted supportive chronic disease management for home care clients. We aim to evaluate the effectiveness and preliminary cost effectiveness of a targeted, person-centred cardiorespiratory management model.
METHODS AND ANALYSIS


The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines. The trial will be conducted in partnership with three regional, public-sector, home care providers across Canada. The primary outcome of the trial is the difference in time to first unplanned ED visit (hazard rate) within 6 months. Additional secondary outcomes are to identify changes in patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness over 6 months. We will also investigate the difference in the number of unplanned ED visits, number of inpatient hospitalisations and changes in health-related quality of life. Multilevel proportional hazard and generalised linear models will be used to test the primary and secondary hypotheses. Sample size simulations indicate that enrolling 1100 home care clients across 36 clusters (home care caseloads) will yield a power of 81% given an HR of 0.75.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Hamilton Integrated Research Ethics Board as well as each participating site's ethics board. Results will be submitted for publication in peer-reviewed journals and for presentation at relevant conferences. Home care service partners will also be informed of the study's results. The results will be used to inform future support strategies for older adults receiving home care services.
TRIAL REGISTRATION NUMBER


NCT03012256.",2019,"The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines.","['home care clients', 'home care', 'partnership with three regional, public-sector, home care providers across Canada', 'Home care service partners', 'older adults receiving home care services']",['cardiorespiratory management'],"['patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness', 'time to first unplanned ED visit (hazard rate']","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",1100.0,0.121819,"The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines.","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Costa', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada acosta@mcmaster.ca.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Schumacher', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Darly', 'Initials': 'D', 'LastName': 'Dash', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Campbell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Junek', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chaim M', 'Initials': 'CM', 'LastName': 'Bell', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Boscart', 'Affiliation': 'Schlegel Centre for Advancing Seniors Care, Conestoga College Institute of Technology and Advanced Learning, Kitchener, Ontario, Canada.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Bronskill', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feeny', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hébert', 'Affiliation': 'Department of Medicine, Universite de Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Heckman', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hirdes', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'McKelvie', 'Affiliation': 'Department of Medicine, Western University, London, Ontario, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mitchell', 'Affiliation': 'Home Care, Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Sinha', 'Affiliation': 'Departments of Medicine, Family and Community Medicine, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Information Management, Western Health Care Corp, Corner Brook, Newfoundland, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Priddle', 'Affiliation': 'Community Support, Western Health Care Corp, Corner Brook, Newfoundland, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Rose', 'Affiliation': ""Department of Health and Community Services, Government of Newfoundland and Labrador, Saint John's, Newfoundland, Canada.""}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Gillan', 'Affiliation': 'Community Health Services, Island Health, Victoria, British Columbia, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Community Health Services, Island Health, Victoria, British Columbia, Canada.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Haughton', 'Affiliation': 'Hamilton Niagara Haldimand Brant Local Health Integration Network, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-030301']
563,31912860,The effect of regular consumption of lupin-containing foods on glycaemic control and blood pressure in people with type 2 diabetes mellitus.,"BACKGROUND


Type 2 diabetes mellitus is a metabolic disorder characterized by high glucose and insulin resistance. It is strongly linked to lifestyle, including poor diet and physical inactivity. Lupin is a novel food ingredient, rich in protein and fibre with negligible sugar and starch, which can be incorporated into various foods to reduce glycaemic load. Regular consumption of lupin-enriched foods may be a novel and easily achievable means of reducing overall glycaemic load and improving glycaemic control in diabetes.
OBJECTIVE


To determine whether regular consumption of lupin-enriched foods can improve glycaemic control and lower blood pressure in people with type 2 diabetes mellitus.
DESIGN


Fourteen men and 8 women (mean age 58.0 ± 6.6 years and BMI 29.0 ± 3.5 kg m-2) with type 2 diabetes mellitus were recruited from the general population to take part in a double-blind, randomised, controlled cross-over study. Participants consumed lupin or control foods for breakfast and lunch every day, and for dinner at least 3 days per week during the 8-week treatment periods. Lupin-enriched foods consisted of bread, pasta, Weetbix™ cereal and crumbs, with energy-matched control products. Treatments were completed in random order with an 8-week washout period. All participants monitored their blood glucose levels pre- and post-breakfast and lunch, and their blood pressure in the morning and evening, 3 days per week for the duration of each treatment period.
RESULTS


Seventeen participants completed both treatment arms, with all 22 participants (14 males, 8 females) analysed on an intention-to-treat basis. Eight weeks consumption of lupin-enriched food had no significant effect on mean blood glucose levels (mean difference: -0.08 ± 0.06 mmol L-1, p = 0.214) or post-prandial blood glucose levels (-0.13 ± 0.10 mmol L-1, p = 0.196). There was no effect on home systolic (-0.4 ± 0.4 mmHg, p = 0.33) or diastolic (0.3 ± 0.3 mmHg, p = 0.321) blood pressure and heart rate (0.5 ± 0.3 bpm, p = 0.152), and no effect on body weight throughout the treatment periods.
CONCLUSION


Regular consumption of lupin-enriched foods had no significant effect on glycaemic control or blood pressure in people with type 2 diabetes mellitus.",2020,"There was no effect on home systolic (-0.4 ± 0.4 mmHg, p = 0.33) or diastolic (0.3 ± 0.3 mmHg, p = 0.321) blood pressure and heart rate (0.5 ± 0.3 bpm, p = 0.152), and no effect on body weight throughout the treatment periods.
","['Seventeen participants completed both treatment arms, with all 22 participants (14 males, 8 females) analysed on an intention-to-treat basis', 'people with type 2 diabetes mellitus', 'Fourteen men and 8 women (mean age 58.0 ± 6.6 years and BMI 29.0 ± 3.5 kg m-2) with type 2 diabetes mellitus']","['regular consumption of lupin-enriched foods', 'regular consumption of lupin-containing foods', 'Lupin-enriched foods consisted of bread, pasta, Weetbix™ cereal and crumbs, with energy-matched control products']","['glycaemic control and blood pressure', 'blood pressure and heart rate', 'post-prandial blood glucose levels', 'home systolic', 'mean blood glucose levels', 'glycaemic control or blood pressure', 'blood pressure', 'blood glucose levels pre- and post-breakfast and lunch, and their blood pressure', 'body weight']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016498', 'cui_str': 'Enriched Food'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",17.0,0.0503602,"There was no effect on home systolic (-0.4 ± 0.4 mmHg, p = 0.33) or diastolic (0.3 ± 0.3 mmHg, p = 0.321) blood pressure and heart rate (0.5 ± 0.3 bpm, p = 0.152), and no effect on body weight throughout the treatment periods.
","[{'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ward', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia. Natalie.ward@curtin.edu.au.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Mori', 'Affiliation': ''}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Seng Khee', 'Initials': 'SK', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Puddey', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Connolly', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': ''}]",Food & function,['10.1039/c9fo01778j']
564,31602695,A placebo controlled randomized clinical trial of Crocus sativus L. (saffron) on depression and food craving among overweight women with mild to moderate depression.,"WHAT IS KNOWN AND OBJECTIVE


Crocus sativus L., commonly known as saffron, has known anti-depressive properties. However, its effects on food craving and body weight in depressed patients are unknown. Hence, we aimed to evaluate the effects of saffron capsules on food craving, body weight and depression among overweight women with mild and moderate depression compared to the placebo.
METHODS


Seventy-three women with BMI ≥ 25 comorbid with mild-to-moderate depression were recruited in this 12-week double-blind, placebo-controlled randomized clinical trial. Participants were randomly assigned into one of the two groups receiving daily either 30 mg of Crocus sativus capsules (15 mg twice/day) or placebo capsules (twice/day). We performed body composition assessments, and beck depression inventory-II at the baseline, and then 2, 4, 8 and 12 weeks later. One month after the participants stopped taking the capsules, weight differences were measured and compared between groups.
RESULTS AND DISCUSSION


Fifty-two patients finished the study. The demographic and clinical variables at baseline were the same in two groups. Mean depression scores in the saffron group significantly decreased compared to placebo (mean ± SD: -8.4 score ± 5.9 vs -3.9 ± 5.5; t[50] = 2; P = .007; 95% CI: 1.3-7.7). There was not a significant effect of saffron on food craving using repeated-measures ANOVA, F(1, 29) = 0.38, P = .54. Patients in the saffron group showed fewer side effects.
WHAT IS NEW AND CONCLUSION


Saffron capsules were not effective in reducing food craving, but as a safe over-the-counter supplement, it may help reduce the symptoms of depression in patients who experience mild or moderate depression and are overweight.",2020,Mean depression scores in the saffron group significantly decreased compared to placebo (mean ± SD: -8.4 score ± 5.9 vs -3.9 ± 5.5; t[50] = 2; P = .007; 95% CI: 1.3-7.7).,"['25 comorbid with mild-to-moderate depression', 'overweight women with mild to moderate depression', 'patients who experience mild or moderate depression and are overweight', 'Seventy-three women with BMI', 'overweight women with mild and moderate depression']","['placebo capsules', 'Crocus sativus L. (saffron', '30\xa0mg of Crocus sativus capsules', 'placebo', 'saffron capsules']","['side effects', 'food craving and body weight', 'Mean depression scores', 'food craving', 'food craving, body weight and depression', 'depression and food craving']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0946614', 'cui_str': 'Crocus sativus'}, {'cui': 'C2348128', 'cui_str': 'Saffron'}, {'cui': 'C0376238', 'cui_str': 'Saffron'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",73.0,0.390068,Mean depression scores in the saffron group significantly decreased compared to placebo (mean ± SD: -8.4 score ± 5.9 vs -3.9 ± 5.5; t[50] = 2; P = .007; 95% CI: 1.3-7.7).,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatry & Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed-Ali', 'Initials': 'SA', 'LastName': 'Mostafavi', 'Affiliation': 'Psychiatry & Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Keshavarz', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatry & Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Eshraghian', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13040']
565,31786218,Nitinol Stent Versus Bypass in Long Femoropopliteal Lesions: 2-Year Results of a Randomized Controlled Trial.,"OBJECTIVES


This study sought to compare patency rates and clinical outcomes of nitinol stents and primary vein bypass in long femoropopliteal lesions.
BACKGROUND


An endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery. Nitinol stents are widely used as the standard endovascular therapy.
METHODS


A single-center randomized controlled trial was performed with the primary endpoints of technical success, primary and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.
RESULTS


A total of 110 limbs (55 per group) in 103 patients were treated. Baseline and lesion characteristics were similar, with a mean lesion length of 276 mm. Critical limb threatening ischemia was the indication for treatment in 49% of limbs in both groups. Technical success was achieved in 87% in the stent group. During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups. At 24 months, primary and secondary patency rates for the stent group were 60% and 72% versus 56% and 73% in the bypass group, respectively. Clinical improvement was significantly better in the bypass group.
CONCLUSIONS


There were no significant differences regarding patency rates, limb salvage, survival, or complications after 2 years. Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable. Mid- as well as long-term results need to be awaited.",2019,"During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups.","['A total of 110 limbs (55 per group) in 103 patients were treated', 'Long Femoropopliteal Lesions']","['Nitinol stents', 'Nitinol Stent Versus Bypass', 'nitinol stents and primary vein bypass']","['patency rates and clinical outcomes', 'technical success, primary and secondary patency', 'Technical success', 'secondary patency rates', 'limb salvage, survival, complications, and clinical improvement', 'patency rates, limb salvage, survival and complications', 'Technical success and clinical improvement', 'patency rates, limb salvage, survival, or complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",103.0,0.129423,"During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups.","[{'ForeName': 'Florian K', 'Initials': 'FK', 'LastName': 'Enzmann', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria. Electronic address: f.enzmann@salk.at.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nierlich', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Aspalter', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hitzl', 'Affiliation': 'Research Office (Biostatistics), Paracelsus Medical University, Salzburg, Austria; Department of Ophthalmology and Optometry, Paracelsus Medical University, Salzburg, Austria; Research Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Dabernig', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hölzenbein', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Ugurluoglu', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Seitelberger', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Linni', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.006']
566,31871250,Drain in laparoscopic cholecystectomy in acute calculous cholecystitis: a randomised controlled study.,"BACKGROUND


There is paucity of evidence regarding the role of drain in laparoscopic cholecystectomy (LC) in acute calculous cholecystitis (ACC), and surgeons have placed the drains based on their experiences, not on evidence-based guidelines. This study aims to assess the value of drain in LC for ACC in a randomised controlled prospective study.
PATIENTS AND METHODS


All patients with mild and moderate ACC undergoing LC were assessed. Preoperatively, patients with choledocholithiasis, Mirizzi syndrome and biliary stent were excluded. Intraoperatively or postoperatively, patients with complications, partial cholecystectomies and malignancies were excluded. Patients were randomised using computer-generated random numbers into two groups at the end of cholecystectomy before closure. Requirement of radiologically guided (ultrasonography () or CT) percutaneous aspiration/drainage of symptomatic intra-abdominal collection or reoperation; continuation of parenteral antibiotics beyond 24 hours or change in antibiotics empirically or based on peritoneal fluid culture sensitivity; requirement of postoperative USG or CT scan based on postoperative clinical course; wound infection rates; postoperative pain using numeric rating scale at 6 and 24 hours; and the duration of hospital stay in both groups were noted.
RESULTS


Forty-two out of 50 consecutive patients were randomised into two equal groups. Pain score at 6 and 24 hours was less in patients without drain. All other complication rates and duration of stay were similar in both groups.
CONCLUSIONS


Drains should not be placed routinely after LC in ACC as it increases pain and does not help in detecting or decreasing complications.",2020,"All other complication rates and duration of stay were similar in both groups.
","['patients with choledocholithiasis, Mirizzi syndrome and biliary stent were excluded', 'All patients with mild and moderate ACC undergoing LC were assessed', 'acute calculous cholecystitis (ACC', 'acute calculous cholecystitis', 'Forty-two out of 50 consecutive patients']","['laparoscopic cholecystectomy (LC', 'radiologically guided (ultrasonography () or CT) percutaneous aspiration/drainage', 'laparoscopic cholecystectomy', 'postoperative USG or CT scan', 'Drain', 'parenteral antibiotics']","['complication rates and duration of stay', 'pain', 'Pain score', 'duration of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0701818', 'cui_str': 'Choledocholithiasis'}, {'cui': 'C0267878', 'cui_str': 'Mirizzi Syndrome'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent (physical object)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0149520', 'cui_str': 'Acute Cholecystitis'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1293115', 'cui_str': 'Percutaneous aspiration'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",50.0,0.0895906,"All other complication rates and duration of stay were similar in both groups.
","[{'ForeName': 'Mithun V', 'Initials': 'MV', 'LastName': 'Valappil', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Chhabra', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mandal', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Sanjay De', 'Initials': 'S', 'LastName': 'Bakshi', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Avik', 'Initials': 'A', 'LastName': 'Bhattacharyya', 'Affiliation': 'Interventional Radiology, Calcutta Medical Research Institute, Kolkata, India.'}, {'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Ghatak', 'Affiliation': 'Surgical Gastroenterology, Calcutta Medical Research Institute, Kolkata, India drsupriyo@yahoo.co.in.'}]",Postgraduate medical journal,['10.1136/postgradmedj-2019-136828']
567,31857014,Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.,"OBJECTIVES


This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.
BACKGROUND


Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).
METHODS


This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.
RESULTS


Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).
CONCLUSIONS


Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).",2019,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","['Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California', 'Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n\xa0=\xa0151) or RV (n\xa0=\xa0152) stimulation groups']","['standard right ventricular (RV) stimulation', 'Left Ventricular Rapid Pacing Via', 'LV or RV stimulation', 'Transcatheter Aortic Valve Replacement', 'Via\xa0the Valve Delivery Guide-wire in TAVR', 'left ventricular (LV) stimulation via a guidewire-reduced procedure duration']","['procedural success', 'efficacy, safety, and cost at 30\xa0days', 'procedure duration', '30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement', 'fluoroscopy time', 'Safety of stimulation', 'procedure duration, fluoroscopy time, and cost, with similar efficacy and safety', 'Effective stimulation', 'Mean procedure duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0181089', 'cui_str': 'Catheter guide wire'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",307.0,0.147618,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Faurie', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France. Electronic address: faurieb@gmail.com.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Staat', 'Affiliation': 'Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Godin', 'Affiliation': 'Cardiology Department, Clinique Saint Hilaire, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Cardiology Department, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Département de cardiologie, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Mangin', 'Affiliation': 'Cardiology Department, Centre Hospitalier Annecy Genevois, Epagny, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meyer', 'Affiliation': 'Cardiology Department, Institut Arnault Tzanck, Saint-Laurent-du-Var, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Cardiology Department, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdellaoui', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Monségu', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Cardiology Department, URC-Eco Île de France, Hôpital de l'Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.029']
568,31886683,Parenting in 2 worlds: Effects of a culturally grounded parenting intervention for urban American Indians on participant cultural engagement.,"BACKGROUND


Culturally appropriate, evidence-based prevention programs are seldom available to the growing majority of American Indians (AIs) who now live in cities. Parenting in 2 Worlds (P2W), a culturally grounded parenting intervention, was created to strengthen family functioning and reduce behavioral health risks in urban AI families from diverse tribal backgrounds.
OBJECTIVES


This study reports on the AI cultural engagement of the P2W participants as an outcome of the intervention.
METHOD


Data came from 575 parents of AI children (ages 10-17) in a randomized controlled trial in three Arizona cities. Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W). Both P2W and HF2W consisted of 10 workshops delivered weekly by AI community facilitators. Pretests and posttests measured identification and engagement with traditional AI heritage, culture and practices. Tests of the efficacy of P2W versus HF2W used baseline adjusted regression models using FIML estimation to adjust for attrition, including random effects (site, facilitator), and controlling dosage. Moderated treatment effects by pretest levels of cultural engagement were tested with mean centered interactions.
RESULTS


Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification. Increases in cultural engagement were significantly larger for P2W participants who were relatively less culturally engaged at pretest.
CONCLUSIONS


Culturally adapted parenting interventions like P2W that effectively build on AI cultural heritage can also promote greater AI cultural identification and involvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","['Data came from 575 parents of AI children (ages 10-17', 'urban AI families from diverse tribal backgrounds', 'urban American Indians on participant cultural engagement', 'Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W']",['culturally grounded parenting intervention'],"['AI ethnic identity, AI spirituality, and positive mainstream cultural identification', 'cultural engagement', 'behavioral health risks']","[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0600220', 'cui_str': 'Family Health'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],"[{'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2019.0,0.0349673,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","[{'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Kulis', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tsethlikai', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Hibbeler', 'Affiliation': 'Phoenix Indian Center.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Nicholet', 'Initials': 'N', 'LastName': 'Deschine Parkhurst', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}]",Cultural diversity & ethnic minority psychology,['10.1037/cdp0000315']
569,31883223,Circulatory and ventilatory power in diabetic patients: Secondary analysis of a randomized controlled trial.,"BACKGROUND


Circulatory (CP) and ventilatory power (VP) have been used to improve the prognostic accuracy of cardiopulmonary exercise tests in cardiovascular disease, such as coronary artery disease. However, the effects of combined resistance and aerobic exercise program on VP and CP, especially in type 2 diabetes patients, have not been adequately investigated. Thus, this new parameter can be useful to prescribe exercise programs more assertive for this population. The present study aimed to assess the effect of 3 months of combined resistance and aerobic exercise training (CET) on CP and VP in patients with type 2 diabetes.
METHODS


A randomized controlled trial was conducted involving 48 diabetic patients with an average age of 52.4 (±8.01) years old. The subjects were randomized into two groups: sedentary (SG, n = 15) and the CET group (n = 19). Cardiopulmonary exercise testing (symptom-limited incremental) was performed on a cycle ergometer, and the following parameters were measured: relative VO 2  , V E  /VCO 2  slope, linear relationship between oxygen uptake and minute ventilation, and VCO 2  . CET was performed with 30-min aerobic and 30-min resistance exercises three times a week for 12 weeks.
RESULTS


Significant (p < .05) and clinical (d ≥ .80) differences were observed that favoured CET compared with SG for the following variables: heart rate, workload, VO 2  relative peak, circulatory power peak, and VCO 2  peak. Although no statistical difference was observed for ventilatory power, there was a clinical difference (p > .05 and d ≥ 0.80) that favoured CET.
CONCLUSION


Three months of combined exercise training improved VP and CP indices in patients with type 2 diabetes when compared with a sedentary group.",2020,"p < .05) and clinical (d ≥ .80) differences were observed that favoured CET compared with SG for the following variables: heart rate, workload, VO 2  relative peak, circulatory power peak, and VCO 2  peak.","['diabetic patients', 'patients with type 2 diabetes', 'type 2 diabetes patients', '48 diabetic patients with an average age of 52.4 (±8.01) years old']","['combined exercise training', 'combined resistance and aerobic exercise program', 'combined resistance and aerobic exercise training (CET', 'CET', 'Circulatory (CP) and ventilatory power (VP']","['heart rate, workload, VO 2  relative peak, circulatory power peak, and VCO 2  peak', 'VP and CP indices', 'oxygen uptake and minute ventilation, and VCO 2  ', 'ventilatory power', 'Circulatory and ventilatory power']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}]",48.0,0.0442827,"p < .05) and clinical (d ≥ .80) differences were observed that favoured CET compared with SG for the following variables: heart rate, workload, VO 2  relative peak, circulatory power peak, and VCO 2  peak.","[{'ForeName': 'Aldair Darlan', 'Initials': 'AD', 'LastName': 'Santos-de-Araújo', 'Affiliation': 'Department of Physical Therapy, Tiradentes University Center, Maceió, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bassi-Dibai', 'Affiliation': 'Postgraduate Program in Management and Health Services, Ceuma University, São Luís, Brazil.'}, {'ForeName': 'Thalita Pereira', 'Initials': 'TP', 'LastName': 'Veiga', 'Affiliation': 'Postgraduate Program in Management and Health Services, Ceuma University, São Luís, Brazil.'}, {'ForeName': 'Flávia Cristina Rossi', 'Initials': 'FCR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'José Carlos Bonjorno', 'Initials': 'JCB', 'LastName': 'Júnior', 'Affiliation': 'Department of Medicine, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Pedro Vellosa', 'Initials': 'PV', 'LastName': 'Schwartzmann', 'Affiliation': 'Clinics Hospital, Medical School of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rodrigo Polaquini', 'Initials': 'RP', 'LastName': 'Simões', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physical Therapy Laboratory, Federal University of São Carlos, São Carlos, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1830']
570,31886828,Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial.,"Importance


Staphylococcus aureus is a leading cause of health care-associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease.
Objective


To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
Design, Setting, and Participants


Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S aureus-colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018.
Interventions


Parents were assigned to intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days.
Main Outcomes and Measures


The primary end point was concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections.
Results


Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired S aureus colonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant S aureus colonization (risk difference, -14.1% [95% CI, -30.8% to -3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any S aureus strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo).
Conclusions and Relevance


In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT02223520.",2020,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","['76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up', '190 neonates included in the analysis, 74 (38.9', 'Neonates (n\u2009=\u2009236) with S aureus-colonized parent(s) were enrolled', ' 208 were included in the analytic sample (55% male', 'Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit', '76% singleton births; mean birth weight, 1985 g [SD, 958 g', 'The study period was November 7, 2014, through December 13, 2018', '236 randomized neonates', 'parents to neonates']","['placebo', 'intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n\u2009=\u2009117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n\u2009=\u2009119) for 5 days', 'intranasal mupirocin and topical chlorhexidine', 'intranasal mupirocin and chlorhexidine-impregnated cloths']","['neonatal acquisition of any S aureus strain and neonatal S aureus infections', 'acquired S aureus colonization', 'neonatal acquisition of an S aureus strain', 'neonatal colonization', 'Skin reactions', 'transmission of S aureus', 'concordant S aureus colonization']","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",236.0,0.562881,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Voskertchian', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Khamash', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Ross', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Carroll', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.20785']
571,31887715,Self-management based coaching program to improve diabetes mellitus self-management practice and metabolic markers among uncontrolled type 2 diabetes mellitus in Indonesia: A quasi-experimental study.,"Diabetes mellitus self-management practice is an essential part of diabetes management among uncontrolled type 2 diabetes mellitus (T2DM). This study aimed to examine the effectiveness of the diabetes mellitus self-management (DMSM) based coaching program on improvement of the DMSM practice and metabolic markers. A quasi-experimental study, pre-test, and post-test design with the non-equivalent control group were applied in this study. Sixty samples were selected and were randomly assigned to both the experimental group and the control group. The Diabetes Self-Management Questionnaire (DSMQ) was used to measure the DMSM practice, while metabolic biomarkers were assessed by using the laboratory test. We conducted and compared the DMSM practice and clinical value at baseline and 12 weeks after completing the program. The DMSM based coaching program was a 12-week program with several strategies based on a self-management model. The findings showed that patients who received the DMSM based coaching program have a positive effect on DMSM practice and metabolic marker except for body mass index (BMI). This study revealed that the DMSM based coaching program was practical and feasible for implementation in a broad population with uncontrolled T2DM in Indonesia.",2020,This study revealed that the DMSM based coaching program was practical and feasible for implementation in a broad population with uncontrolled T2DM in Indonesia.,"['Sixty samples', 'uncontrolled type 2 diabetes mellitus in Indonesia']","['DMSM based coaching program', 'Self-management based coaching program', 'diabetes mellitus self-management (DMSM) based coaching program']","['DMSM practice and metabolic marker except for body mass index (BMI', 'Diabetes Self-Management Questionnaire (DSMQ']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0117062,This study revealed that the DMSM based coaching program was practical and feasible for implementation in a broad population with uncontrolled T2DM in Indonesia.,"[{'ForeName': 'Rian Adi', 'Initials': 'RA', 'LastName': 'Pamungkas', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Esa Unggul University, Jakarta, 11530, Indonesia. Electronic address: rian.adi@esaunggul.ac.id.'}, {'ForeName': 'Kanittha', 'Initials': 'K', 'LastName': 'Chamroonsawasdi', 'Affiliation': 'Department of Family Health, Faculty of Public Health, Mahidol University, Bangkok, 10400, Thailand. Electronic address: kanittha.cha@mahidol.ac.th.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2019.12.002']
572,30758110,Randomized control trial comparing the titanium osteosynthesis and the biodegradable osteosynthesis in mandibulotomy access.,"BACKGROUND


The clinical degradation rate and strength of biodegradable implant exposed to postoperative radiotherapy (PORT) are unknown.
METHODS


A prospective randomized control trial of 40 consecutive mandibulotomy patients randomly divided into titanium and biodegradable cohorts. All patients received PORT. The following parameters were compared: maximal mouth opening, occlusal force, center of force trajectory, occlusal status, radiographic evidence of bony union, mandibular function impairment questionnaire (MFIQ), overall satisfaction score, and complication rates.
RESULTS


Both the mandibular function and occlusal status parameter of the biodegradable and the titanium groups were not significantly difference. Biodegradable cohort showed better MFIQ scores (P = .08) and overall satisfaction scores (P = .64) but was not statistically significant. Of note, 40% of patients in the titanium cohort complained of plate palpability/cold intolerance and required plate removal (P = .02); 10% of patients in the titanium cohort developed osteoradionecrosis.
CONCLUSION


Biodegradable osteosynthesis is as reliable as titanium osteosynthesis for mandibulotomy fixation. PORT did not increase the complication rate in the biodegradable group.",2019,Biodegradable cohort showed better MFIQ scores (P = .08) and overall satisfaction scores (P = .64) but was not statistically significant.,['40 consecutive mandibulotomy patients randomly divided into titanium and biodegradable cohorts'],"['PORT', 'postoperative radiotherapy (PORT', 'Biodegradable osteosynthesis', 'titanium osteosynthesis']","['overall satisfaction scores', 'maximal mouth opening, occlusal force, center of force trajectory, occlusal status, radiographic evidence of bony union, mandibular function impairment questionnaire (MFIQ), overall satisfaction score, and complication rates', 'MFIQ scores', 'complication rate', 'plate palpability/cold intolerance and required plate removal']","[{'cui': 'C0185524', 'cui_str': 'Mandibulotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0009269', 'cui_str': 'Intolerant of cold (finding)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",40.0,0.0671902,Biodegradable cohort showed better MFIQ scores (P = .08) and overall satisfaction scores (P = .64) but was not statistically significant.,"[{'ForeName': 'Jian Nan', 'Initials': 'JN', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Maxillofacial-Head & Neck Oncology, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hui Shan', 'Initials': 'HS', 'LastName': 'Ong', 'Affiliation': ""Department of Oral Maxillofacial-Head & Neck Oncology, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Ming Yi', 'Initials': 'MY', 'LastName': 'Wang', 'Affiliation': ""Department of Oral Maxillofacial-Head & Neck Oncology, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wan', 'Affiliation': 'Oral Maxillofacial Surgery Department, Oral Health Centre of Western Australia, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Xing Zhou', 'Initials': 'XZ', 'LastName': 'Qu', 'Affiliation': ""Department of Oral Maxillofacial-Head & Neck Oncology, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Chen Ping', 'Initials': 'CP', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral Maxillofacial-Head & Neck Oncology, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",Head & neck,['10.1002/hed.25509']
573,31854292,Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT.,"BACKGROUND


People with serious mental illness have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health.
OBJECTIVES


To develop a sexual health promotion intervention for people with serious mental illness, and to conduct a feasibility trial in order to establish the acceptability and parameters for a fully powered trial.
DESIGN


A two-armed randomised controlled, open feasibility study comparing usual care alone with usual care plus the adjunctive intervention.
SETTING


Five community mental health providers in Leeds, Barnsley, Brighton and London.
PARTICIPANTS


Adults aged ≥ 18 years with serious mental illness and receiving care from community mental health teams.
INTERVENTIONS


A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on knowledge, motivation and behavioural intentions to adopt safer sexual behaviours.
MAIN OUTCOME MEASURES


Feasibility parameters including establishing the percentage of people who were eligible, consented and were retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life. Data were collected at baseline and then at 3 months and 6 months post randomisation.
RESULTS


Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial.
CONCLUSIONS


Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a sexual health promotion study for people with serious mental illness.
FUTURE WORK


A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN15747739.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.",2019,No adverse events were reported.,"['29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm', 'Adults aged ≥\u200918 years with serious mental illness and receiving care from community mental health teams', 'people with serious mental illness', 'Five community mental health providers in Leeds, Barnsley, Brighton and London', '72 people participated in the trial over 12 months', 'people with severe mental illness', '100 participants', 'People with serious mental illness']","['sexual health promotion intervention', 'usual care alone with usual care plus the adjunctive intervention', 'Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm']","['Sexual health promotion', 'adverse events', 'knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life']","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",100.0,0.130031,No adverse events were reported.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Thirimon', 'Initials': 'T', 'LastName': 'Moe-Byrne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Edmondson', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lottie', 'Initials': 'L', 'LastName': 'Millett', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Dare', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, University of Sussex, Brighton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23650']
574,31868978,Gross motor adaptation benefits from sleep after training.,"Sleep has been shown to facilitate the consolidation of newly acquired motor memories. However, the role of sleep in gross motor learning, especially in motor adaptation, is less clear. Thus, we investigated the effects of nocturnal sleep on the performance of a gross motor adaptation task, i.e. riding an inverse steering bicycle. Twenty-six male participants (M = 24.19, SD = 3.70 years) were randomly assigned to a PM-AM-PM (n = 13) or an AM-PM-AM (n = 13) group, i.e. they trained in the evening/morning and were re-tested the next morning/evening and the following evening/morning (PM-AM-PM/AM-PM-AM group) so that every participant spent one sleep as well as one wake interval between the three test sessions. Inverse cycling performance was assessed by speed (riding time) and accuracy (standard deviation of steering angle) measures. Behavioural results showed that in the PM-AM-PM group a night of sleep right after training stabilized performance (accuracy and speed) and was further improved over the subsequent wake interval. In the AM-PM-AM group, a significant performance deterioration after the initial wake interval was followed by the restoration of subjects' performance levels from right after training when a full night of sleep was granted. Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"". Our results demonstrate that sleep facilitates the consolidation of gross motor adaptation, thus adding further insights to the role of sleep for tasks with real-life relevance.",2020,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","['3.70\xa0years', 'Twenty-six male participants (M\xa0=\xa024.19, SD\xa0']",['PM-AM-PM (n\xa0=\xa013) or an AM-PM-AM'],"['Inverse cycling performance', 'speed (riding time) and accuracy (standard deviation of steering angle) measures']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0553654', 'cui_str': 'Does steer (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",26.0,0.0137131,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Bothe', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Hirschauer', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Wiesinger', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Janina M', 'Initials': 'JM', 'LastName': 'Edfelder', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Hoedlmoser', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Birklbauer', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}]",Journal of sleep research,['10.1111/jsr.12961']
575,31315685,Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial.,"BACKGROUND


Economic vulnerability, such as homelessness and unemployment, contributes to the HIV risk among racial minorities in the U.S., who are disproportionately infected. Yet, few economic-strengthening interventions have been adapted for HIV prevention in economically-vulnerable African-American young adults. Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages (""nudges"") that are informed by behavioral economic principles. The trial aims to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors.
METHODS/DESIGN


In total, 40 young adults who are African-American, aged 18-24, live in Baltimore City, have experienced at least one episode of homelessness in the last 12 months, are unemployed or underemployed (fewer than 10 h per week), are not enrolled in school, own a cell phone with text messaging, and report at least one episode of unprotected or unsafe sex in the prior 12 months will be recruited from two community-based organizations providing residential supportive services to urban youth. Participants will undergo a 3-week run-in period and thereafter be randomly assigned to one of two groups with active interventions for 20 weeks. The first group (""comparison"") will receive text messages with information on job openings. The second group (""experimental"") will receive text messages with information on job openings plus information on HIV prevention and business educational sessions, a mentored apprenticeship, and a start-up grant, and business and HIV prevention text messages based on principles from behavioral economics. The two primary outcomes relate to the feasibility of conducting a larger trial. Secondary outcomes relate to employment, sexual risk behaviors, and HIV preventive practices. All participants will be assessed using an in-person questionnaire at pre-intervention (prior to randomization) and at 3 weeks post-intervention. To obtain repeated, longitudinal measures, participants will be assessed weekly using text message surveys from pre-intervention up to 3 weeks post-intervention.
DISCUSSION


This study will be one of the first U.S.-based feasibility randomized clinical trials of an HIV prevention microenterprise intervention for economically-vulnerable African-American young adults. The findings will inform whether and how to conduct a larger efficacy trial for HIV risk reduction in this population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018.",2019,"Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages (""nudges"") that are informed by behavioral economic principles.","['40 young adults who are African-American, aged 18-24, live in Baltimore City, have experienced at least one episode of homelessness in the last 12\u2009months, are unemployed or underemployed (fewer than 10\u2009h per week), are not enrolled in school, own a cell phone with text messaging, and report at least one episode of unprotected or unsafe sex in the prior 12\u2009months will be recruited from two community-based organizations providing residential supportive services to urban youth', 'economically-vulnerable African-American young adults']","['HIV prevention microenterprise intervention', 'Microenterprise intervention', 'text messages with information on job openings plus information on HIV prevention and business educational sessions, a mentored apprenticeship, and a start-up grant, and business and HIV prevention text messages based on principles from behavioral economics']","['sexual risk behaviors', 'employment, sexual risk behaviors, and HIV preventive practices']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041674', 'cui_str': 'Unemployment'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}]","[{'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}]",40.0,0.115064,"Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages (""nudges"") that are informed by behavioral economic principles.","[{'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA. ljennin6@jhu.edu.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, 525 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, The Brown School, Goldfarb, One Brookings, Drive, St. Louis, MO, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Fatmata', 'Initials': 'F', 'LastName': 'Timbo', 'Affiliation': 'Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Behavioral Pharmacology Research, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Davoust', 'Affiliation': 'Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Department of International Health, Social and Behavioral Interventions Program, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5038, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dodge', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health, 1025 E. 7th Street, Bloomington, IN, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Hampton House 737, Baltimore, MD, USA.'}]",Trials,['10.1186/s13063-019-3529-7']
576,31339460,How do resistance training and balance and motor control training affect gait performance and fatigue impact in people with multiple sclerosis? A randomized controlled multi-center study.,"BACKGROUND


Despite a shared purpose of improving functional capacity, the principles of progressive resistance training (PRT) and balance and motor control training (BMCT) are fundamentally different.
OBJECTIVES


To investigate the effects of PRT and BMCT on gait performance and fatigue impact in people with multiple sclerosis (PwMS).
METHODS


A multi-center, single-blinded, cluster-randomized controlled trial with two intervention groups (PRT and BMCT) and a control group (CON). The interventions lasted 10 weeks. A total of 71 participants with impaired mobility (Timed 25-Foot Walk (T25FW) > 5 seconds or Six Spot Step Test (SSST) > 8 seconds) were enrolled. Primary outcomes were the T25FW and the SSST. Fatigue impact, self-perceived gait function, 6-minute walk, balance, and muscle strength were secondary outcomes.
RESULTS


In total, 83% completed the study. The primary comparisons showed that BMCT, but not PRT, improved T25FW, SSST, and self-perceived gait function when compared to CON. Secondary comparisons showed that BMCT improved SSST more than PRT, while T25FW did not differ. Both BMCT and PRT reduced the fatigue impact. Finally, the effect of BMCT was superior to PRT on dynamic balance, while PRT was superior to BMCT on knee extensor muscle strength.
CONCLUSION


BMCT, but not PRT, was superior to CON in improving gait performance, while both BMCT and PRT reduced fatigue.",2020,"BMCT, but not PRT, was superior to CON in improving gait performance, while both BMCT and PRT reduced fatigue.","['71 participants with impaired mobility (Timed 25-Foot Walk', 'people with multiple sclerosis (PwMS', 'people with multiple sclerosis']","['BMCT and PRT', 'resistance training and balance and motor control training', 'CON', 'PRT and BMCT', 'control group (CON', 'progressive resistance training (PRT) and balance and motor control training (BMCT', 'BMCT', 'intervention groups (PRT and BMCT']","['BMCT, but not PRT, improved T25FW, SSST, and self-perceived gait function', 'fatigue impact', 'Fatigue impact, self-perceived gait function, 6-minute walk, balance, and muscle strength', 'knee extensor muscle strength', 'gait performance and fatigue impact', 'T25FW and the SSST', 'T25FW', 'gait performance', 'BMCT improved SSST']","[{'cui': 'C0518456', 'cui_str': 'Physical mobility impairment'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",71.0,0.122137,"BMCT, but not PRT, was superior to CON in improving gait performance, while both BMCT and PRT reduced fatigue.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Callesen', 'Affiliation': 'Department of Rehabilitation and Health Promotion Research, Faculty of Health Science, VIA University College, Aarhus N, Denmark/ Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cattaneo', 'Affiliation': 'IRCSS Fondazione Don Carlo Gnocchi, Milano, Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brincks', 'Affiliation': 'Department of Rehabilitation and Health Promotion Research, Faculty of Health Science, VIA University College, Aarhus N, Denmark.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Kjeldgaard Jørgensen', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519865740']
577,32204141,The relationship between the frequency of breastfeeding counseling with the adequacy of breastfeeding to the newborn babies.,"OBJECTIVE


The aim of the research was to determine the relationship between the freuency of breastfeeding counseling with breastfeeding sufficiency of newborn babies of three days postpartum.
METHODS


This research was quasi experimental design. There were 80 primipara divided into 4 groups, each group consist of 20 samples given counseling for one time to group 1, two times to group 2, three times to group 3, and four times to group 4, tested with Friedman, One-way ANOVA, and Kruskal-Wallis tests.
RESULTS


The result indicated that there was no difference among the groups 1, 2, 3, and 4. However, there was a relationship between an increase intake of breastfeeding with the provision of counseling to the breastfeeding mothers on day 1, day 2, and day 3 and to all groups (p=0.001).
CONCLUSION


This showed that the groups given the counseling with different frequency: one time, two times, three times, and four times did not have difference in increasing the sufficiency of breastfeeding although the assistance could give the adequacy of breastfeeding.",2020,"The result indicated that there was no difference among the groups 1, 2, 3, and 4.","['newborn babies', 'newborn babies of three days postpartum']",[],[],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",[],[],,0.013841,"The result indicated that there was no difference among the groups 1, 2, 3, and 4.","[{'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Asmiraha', 'Affiliation': 'School of Post Graduate Midwifery Department, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Alasiry', 'Affiliation': 'Neurology Department, Public Health Faculty, Hasanuddin University, Makassar, Indonesia. Electronic address: emaalasiri@pasca.unhas.ac.id.'}, {'ForeName': 'Werna', 'Initials': 'W', 'LastName': 'Nontji', 'Affiliation': 'Nursing Department, Education Hospital Hasanuddin University, Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.10.011']
578,32208125,Melatonin a Promising Candidate for DNA Double-Stranded Breaks Reduction in Patients Undergoing Abdomen-Pelvis Computed Tomography Examinations.,"BACKGROUND AND OBJECTIVE


Cancer incidence is 24% higher in children and young adults exposed to Computed Tomography (CT) scans than those unexposed. Non-repairing of ionizing radiation-induced DNA Double-Strand Breaks (DSBs) can initiate carcinogenesis. In the present study, we aimed to investigate the radioprotective potential of melatonin against DSBs in peripheral blood lymphocytes of patients undergoing abdomen-pelvis CT examinations.
METHODS


This double-blind, placebo-controlled clinical trial was conducted on thirty patients. These patients were divided into two groups; group one (control) patients who have undergone the CT examination received a single oral dose of placebo, while in group two, patients received a single oral dose of 100mg melatonin. In both the groups, blood samples were collected 5-10min before and 30 minutes after the CT examination. The lymphocytes from these samples were isolated and DSBs were analyzed using γH2AX immunofluorescence microscopy.
RESULTS


Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs. In addition, no side effect was observed in patients following 100mg melatonin administration.
CONCLUSION


For the first time, this study has shown that melatonin has protective effects against radiationinduced genotoxicity in peripheral blood lymphocytes of patients undergoing abdomen-pelvis CT examinations. Therefore, melatonin can be considered as a promising candidate for reducing DSBs in patients undergoing abdomen-pelvis CT examinations.",2020,"Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs.","['Patients Undergoing Abdomen-Pelvis Computed Tomography Examinations', 'patients undergoing the abdomen-pelvis CT examinations', 'thirty patients', 'children and young adults', 'patients undergoing abdomen-pelvis CT examinations']","['placebo', 'single oral dose of 100mg melatonin', 'Computed Tomography (CT) scans', 'Melatonin', 'ionizing radiation-induced DNA double-Strand Breaks (DSBs', 'melatonin', 'melatonin against DSBs']","['DSBs', 'γH2AX-foci', 'blood samples', 'peripheral blood lymphocytes', 'side effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0034538', 'cui_str': 'Ionizing radiation (physical force)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks (finding)'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",30.0,0.146628,"Compared to the control group, the use of melatonin 1h before the CT examination caused a significant reduction in γH2AX-foci, indicating a reduction in DSBs.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eskandari', 'Affiliation': 'Department of Medical Radiation Engineering, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Mahmoudzadeh', 'Affiliation': 'Department of Biosciences and Biotechnology, Malek-Ashtar University of Technology, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shirazi', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, Faculty of Medicine, Tehran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Esmaely', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, Faculty of Medicine, Tehran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Carnovale', 'Affiliation': 'Department of Biomedical and Clinical Sciences L. Sacco, Unit of Clinical Pharmacology, ASST Fatebenefratelli-Sacco University Hospital, Università di Milano, Milan, Italy.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Cheki', 'Affiliation': 'Department of Radiologic Technology, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Anti-cancer agents in medicinal chemistry,['10.2174/1871521409666200324101701']
579,31310038,Fluoroscopy-guided axillary vein access vs cephalic vein access in pacemaker and defibrillator implantation: Randomized clinical trial of efficacy and safety.,"INTRODUCTION


The most widespread venous sites of access for implantation intravenous implantable cardiac electronic device (CIED) are the cephalic and subclavian vein. Fluoroscopy-guided axillary venous access is an alternative, but efficacy and safety have not been studied under equal conditions. The aim of the present study is to compare the efficacy and safety of fluoroscopy-guided axillary vs cephalic vein access in CIED implant.
METHODS AND RESULTS


Two hundred and forty patients were randomized to receive CIED implantation by the fluoroscopy-guided axillary vein access vs cephalic vein access. The implantation success, the procedure times and the complications were recorded. A comparison of the results of operators was made. The success rate of the randomized venous access was superior in the axillary group than in cephalic (98.3% vs 76.7%, P < .001). Time to access (6.8 ± 3.1 minute vs 13.1 ± 5.8 minutes, P < .001) and implantation duration was significantly shorter in the axillary group than in the cephalic group (42.3 ± 11.6 minutes vs 50.5 ± 13.3 minutes, P < .001). There was no difference in the incidence of complication and inter-operator success rate, complications rate and time to access.
CONCLUSION


The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access. When the results were compared among the study operators, neither in the axillary nor in the cephalic group there were differences in the success rate, the complication rate, and the time to access.
TRIAL REGISTRATION


www.clinicaltrials.gov, NCT03860090.",2019,The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access.,"['pacemaker and defibrillator implantation', 'Two hundred and forty patients']","['fluoroscopy-guided axillary vs cephalic vein access', 'Fluoroscopy-guided axillary venous access', 'CIED implantation by the fluoroscopy-guided axillary vein access vs cephalic vein access', 'Fluoroscopy-guided axillary vein access vs cephalic vein access']","['implantation success, the procedure times and the complications', 'incidence of complication and inter-operator success rate, complications rate and time to access', 'success rate', 'implantation duration', 'efficacy and safety', 'success rate, the complication rate, and the time to access']","[{'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",240.0,0.115574,The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jiménez-Díaz', 'Affiliation': 'Arrhythmia Unit, Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Higuera-Sobrino', 'Affiliation': 'Arrhythmia Unit, Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Piqueras-Flores', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Díaz', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'María Arantzazu', 'Initials': 'MA', 'LastName': 'González-Marín', 'Affiliation': 'Cardiology Department, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14060']
580,31318615,Dietary nitrate supplementation enhances cerebrovascular CO 2  reactivity in a sex-specific manner.,"Insufficient nitric oxide (NO) bioavailability plays an important role in endothelial dysfunction, and increased NO has the potential to enhance cerebral blood flow (CBF). Dietary supplementation with sodium nitrate, a precursor of NO, could improve cerebrovascular function, but this has not been investigated. In 17 individuals, we examined the effects of a 7-day supplementation of dietary nitrate (0.1 mmol·kg -1 ·day  -1 ) on cerebrovascular function using a randomized, single-blinded placebo-controlled crossover design. We hypothesized that 7-day dietary nitrate supplementation increases CBF response to CO 2  (cerebrovascular CO 2  reactivity) and cerebral autoregulation (CA). We assessed middle cerebral artery blood velocity (MCAv) and blood pressure (BP) at rest and during CO 2  breathing. Transfer function analysis was performed on resting beat-to-beat MCAv and BP to determine CA, from which phase, gain, and coherence of the BP-MCAv data were derived. Dietary nitrate elevated plasma nitrate concentration by ~420% ( P  < 0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared with placebo treatment ( d  = 0.7,  P  = 0.043), while coherence was unaffected ( P  = 0.122). Dietary nitrate increased the MCAv-CO 2  slope in a sex-specific manner (interaction:  P  = 0.016). Dietary nitrate increased the MCAv-CO 2  slope in men ( d  = 1.0,  P  = 0.014 vs. placebo), but had no effect in women ( P  = 0.919). Our data demonstrate that dietary nitrate greatly increased cerebrovascular CO 2  reactivity in healthy individuals, while its effect on CA remains unclear. The selective increase in the MCAv-CO 2  slope observed in men indicates a clear sexual dimorphic role of NO in cerebrovascular function. NEW & NOTEWORTHY  We found dietary nitrate supplementation improved the brain blood vessels' response to CO 2 , cerebrovascular CO 2  reactivity, without affecting blood pressure in a group of healthy individuals. Meanwhile, the effect of dietary nitrate on the relationship between blood pressure and brain blood flow, cerebral autoregulation, was inconclusive. The improvement in cerebrovascular CO 2  reactivity was only observed in the male participants, alluding to a sex difference in the effect of dietary nitrate on brain blood flow control. Our findings indicate that dietary nitrate could be an effective strategy to enhance cerebrovascular CO 2  reactivity.",2019,"Dietary nitrate elevated plasma nitrate concentration by ˜420% ( P <0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared to placebo treatment ( d =0.7,  P =0.043), while coherence was unaffected ( P =0.122).","['seventeen individuals', 'healthy individuals']","['7-day dietary nitrate supplementation', 'placebo', 'Insufficient nitric oxide ', 'dietary nitrate', 'Dietary nitrate supplementation']","['Dietary nitrate increased the MCAv-CO 2  slope', 'cerebral blood flow (CBF', 'CBF response to CO 2  (cerebrovascular CO 2  reactivity) and cerebral autoregulation (CA', 'middle cerebral artery blood velocity (MCAv) and blood pressure (BP', 'Dietary nitrate elevated plasma nitrate concentration', 'lowered gain', 'cerebrovascular function', 'BP-MCAv signal']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0031843', 'cui_str': 'function'}]",17.0,0.0307434,"Dietary nitrate elevated plasma nitrate concentration by ˜420% ( P <0.001) and lowered gain ( d  = 1.2,  P  = 0.025) and phase of the BP-MCAv signal compared to placebo treatment ( d =0.7,  P =0.043), while coherence was unaffected ( P =0.122).","[{'ForeName': 'Jui-Lin', 'Initials': 'JL', 'LastName': 'Fan', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': ""O'Donnell"", 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Clint Lee', 'Initials': 'CL', 'LastName': 'Gray', 'Affiliation': 'Centre for Translational Physiology, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Annabel Kate', 'Initials': 'AK', 'LastName': 'Noakes', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Koch', 'Affiliation': 'School of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Tzeng', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01116.2018']
581,31995012,Effects of an Antihypertensive Combination in Japanese Hypertensive Outpatients Based on the Long-Acting Calcium Channel Blocker Benidipine on Vascular and Renal Events: A Sub-Analysis of the COPE Trial.,"BACKGROUND


In the trial known as COPE (Combination Therapy of Hypertension to
Prevent Cardiovascular Events), three benidipine (a calcium channel blocker; CCB) regimens were
compared. Hypertensive Japanese outpatients aged 40–85 years (n=3,293) who did not achieve the
target blood pressure of <140/90 mmHg with benidipine 4 mg/day were treated with the diuretic
thiazide (n=1,094) or a β-blocker (n=1,089) or an additional angiotensin receptor blocker (ARB;
n=1,110). A significantly higher incidence of hard cardiovascular composite endpoints and of fatal
or non-fatal strokes was observed in the benidipine-β-blocker group compared to the benidipinethiazide
group.
OBJECTIVE AND METHODS


We further evaluated the treatment effects of the three benidipine-based
regimens on vascular and renal events in a sub-analysis of the COPE patients.
RESULTS


A total of 10 vascular events (0.8 per 1,000 person-years) including one aortic dissection
(0.1 per 1,000 person-years) and nine cases of peripheral artery disease (0.8 per 1,000 person-years)
were documented, as was a total of seven renal events (0.6 per 1,000 person-years). No significant
differences in vascular and renal events were revealed among the three treatment groups: vascular
events, p=0.92; renal events, p=0.16, log-rank test.
CONCLUSIONS


Blood pressure-lowering therapy with benidipine combined with an ARB, β-blocker,
or thiazide was similarly effective in the prevention of vascular and renal events in hypertensive
outpatients, although there are not enough events to compare the difference in the three treatment
groups.",2020,"No significant differences in vascular and renal events were revealed among the three treatment groups: vascular events p=0.92 renal events p=0.16 log-rank test.
","['on Vascular and Renal Events', 'Japanese Hypertensive Outpatients', 'hypertensive outpatients', 'A total of 10 vascular events (0.8 per 1,000 person-years) including one aortic dissection (0.1 per 1,000 person-years) and nine cases of peripheral artery disease (0.8 per 1,000 person-years) were documented, as was a total of seven renal events (0.6 per 1,000 person-years', 'Hypertensive Japanese outpatients aged 40-85 years (n=3,293) who did not achieve the target blood pressure of <140/90 mmHg with benidipine 4 mg/day were treated with the']","['Calcium Channel Blocker Benidipine', 'benidipine-thiazide', 'diuretic thiazide (n=1,094) or a β-blocker (n=1,089) or an additional angiotensin receptor blocker', 'benidipine combined with an ARB, β-blocker, or thiazide', 'benidipine (a calcium channel blocker; CCB', 'benidipine-based regimens', 'Antihypertensive Combination', 'benidipine-β-blocker']","['vascular and renal events', 'hard cardiovascular composite endpoints and of fatal or non-fatal strokes']","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0340643', 'cui_str': 'Aortic Dissection'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0053108', 'cui_str': 'benidipine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0053108', 'cui_str': 'benidipine'}, {'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.0509463,"No significant differences in vascular and renal events were revealed among the three treatment groups: vascular events p=0.92 renal events p=0.16 log-rank test.
","[{'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Umemoto', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Ogihara', 'Affiliation': 'Morinomiya University of Medical Sciences, Osaka, Japan.'}, {'ForeName': 'Masunori', 'Initials': 'M', 'LastName': 'Matsuzaki', 'Affiliation': 'Yamaguchi University, Ube, Yamaguchi, Japan, eShin-oyama City Hospital, Oyama, Tochigi, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Shin-oyama City Hospital, Oyama, Tochigi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of General Medicine, Tokyo Dental College, Ichikawa General Hospital Ichikawa Chiba, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama University, Okayama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Faculty of Science and Engineering, Chuo University, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Saruta', 'Affiliation': 'Keio University, Shinjuku-ku, Tokyo, Japan'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Keio University, Shinjuku-ku, Tokyo, Japan'}]",Current hypertension reviews,['10.2174/1573402116666200129130151']
582,30010175,RE: The Evaluation of the Result of Warm Normal Saline Irrigation in Ureteral Endoscopic Surgeries: A Randomized Clinical Trial.,,2018,,['Ureteral Endoscopic Surgeries'],['RE'],[],"[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}]",[],[],,0.175794,,"[{'ForeName': 'Amir Hosseini', 'Initials': 'AH', 'LastName': 'Kashi', 'Affiliation': 'Hasheminejad Kidney Center (HKC), Iran University of Medical Sciences, Tehran, Iran. ahkashi@gmail.com.'}]",Urology journal,['10.22037/uj.v15i4.4682']
583,31327162,Effect of Low-Level Laser Therapy versus Electroacupuncture on Postnatal Scanty Milk Secretion: A Randomized Controlled Trial.,"OBJECTIVE


Postnatal scanty milk secretion is a common complaint. Some physical and medical interventions were advocated to help milk production. These interventions should be effective and safe for the mother and the infant. This study aimed to compare the effects of low-level laser therapy and electroacupuncture on postnatal scanty milk secretion.
STUDY DESIGN


A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. They were randomly divided into three equal groups: group A (control), group B (those who received low-power He-Ne laser beam on both breasts), and group C (those who received faradic current stimulation at Spleen 6, Liver 3, and Small Intestine 1 acupuncture points on both sides). All participants received 10 mg Domperidone three times a day and were given advice about lactation, nutrition, and fluid intake. Evaluation was done before and after the treatment program.
RESULTS


The mean serum prolactin, infant weight, and visual analog scale (VAS) score were significantly increased in the three groups posttreatment when compared with their corresponding levels pretreatment. Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively). Also, it was significantly elevated in group B more than in group A ( p  = 0.001). The mean value of infant weight was significantly elevated in group C when compared with its corresponding values in both groups A ( p  = 0.001) and B ( p  = 0.029). The VAS score was significantly increased in both groups B and C when compared with group A ( p  = 0.001).
CONCLUSION


Electroacupuncture is more effective than low-level laser therapy in increasing postnatal scanty milk secretion.
CLINICAL TRIAL REGISTRATION


NCT03806062.",2020,"Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively).","['Postnatal Scanty Milk Secretion', '60 healthy primiparous mothers with insufficient lactation']","['Electroacupuncture', 'Domperidone', 'low-power He-Ne laser beam on both breasts), and group C (those who received faradic current stimulation at Spleen 6, Liver 3, and Small Intestine 1 acupuncture points on both sides', 'Low-Level Laser Therapy versus Electroacupuncture', 'low-level laser therapy', 'low-level laser therapy and electroacupuncture']","['VAS score', 'mean value of infant weight', 'mean serum prolactin, infant weight, and visual analog scale (VAS) score', 'Posttreatment serum prolactin']","[{'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0443295', 'cui_str': 'Scanty (qualifier value)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020610', 'cui_str': 'Hypogalactia'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0458142', 'cui_str': 'Laser-generated electromagnetic radiation (physical force)'}, {'cui': 'C0222605', 'cui_str': 'Both breasts (body structure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0490042,"Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively).","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa E', 'Initials': 'ME', 'LastName': 'Hassanin', 'Affiliation': 'Department of Women Health, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Wafaa M', 'Initials': 'WM', 'LastName': 'Kamal', 'Affiliation': 'Department of Women Health, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr H', 'Initials': 'AH', 'LastName': 'Abbassy', 'Affiliation': 'Department of Reproductive Health and Family Planning, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alalfy', 'Affiliation': 'Department of Reproductive Health and Family Planning, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Askalani', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Lithy', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Farouk', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Hammad', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}]",American journal of perinatology,['10.1055/s-0039-1693428']
584,31992459,Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State.,"PURPOSE


Coadministration of lobeglitazone and dapagliflozin is expected to result in a blood glucose-lowering effect, followed by a gradual increase, in clinical usage; however, combining drugs could cause negative interactions. This study aimed to evaluate the effect of the coadministration of lobeglitazone and dapagliflozin on their individual pharmacokinetic properties at steady state in healthy male volunteers in the fasted state.
METHODS


This study consisted of 2 parts, each of which was a randomized, open-labeled, multiple-dose, 2-way crossover study in 20 healthy male volunteers in each part. Blood samples were taken periodically over a 48-h period after dosing to derive total plasma lobeglitazone and dapagliflozin pharmacokinetic properties; safety profile was evaluated throughout the study.
FINDINGS


When the pharmacokinetic properties of dapagliflozin were evaluated following its administration alone and in combination with lobeglitazone, point estimate and 90% CI of the geometric mean ratio of dapagliflozin AUC τ  were entirely within the conventional bioequivalence range of 80%-125%. However, although it was not clinically meaningful, its C ss,max  was ~8% lower in subjects receiving multiple doses of dapagliflozin and lobeglitazone than that in those administered dapagliflozin alone. The pharmacokinetic properties of lobeglitazone were evaluated following its administration alone and in combination with dapagliflozin. The geometric mean ratios and 90% CIs of the lobeglitazone C ss,max  and AUC τ  were within the conventional bioequivalence range of 80%-125%.
IMPLICATIONS


Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug. Based on these findings, it is anticipated that lobeglitazone and dapagliflozin can be coadministered without dose adjustment. ClinicalTrials.gov identifier: NCT03616392.",2020,"IMPLICATIONS


Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug.","['20 healthy male volunteers in each part', 'healthy male volunteers in the fasted state']","['lobeglitazone', 'dapagliflozin and lobeglitazone', 'lobeglitazone and dapagliflozin', 'dapagliflozin']","['geometric mean ratios and 90% CIs of the lobeglitazone C ss,max  and AUC τ']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",20.0,0.0306666,"IMPLICATIONS


Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug.","[{'ForeName': 'Kyungho', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: khjang@jbcp.kr.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: jyjeon@jbcp.kr.'}, {'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: sjmoon@jbcp.kr.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea; Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, South Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.01.003']
585,32204250,Increased Leopold palpation knowledge and skills after learning using the preceptorship method.,"OBJECTIVE


The objective of the study was to analyze the effect of preceptorship learning methods on the knowledge and skills of Leopold palpation of midwifery diploma students.
METHODS


This study was carried out at the School of Health Sciences Midwifery Plamonia VII Wirabuana Makassar Midwifery Study Program, conducted from September to October 2019. The sample in this study amounted to 40 students. Previously carried out pre-test and after the intervention carried out post-test. Preceptorship about Leopold palpation twice a time; the first meeting where the preceptor first gave guidance to the preseptee, which was divided into small groups of 5 people, 1 group. So with a total sample of 40 people, eight groups will be formed, and each group has one certified preceptor. Previously carried out pre-test and after the intervention carried out post-test.
RESULTS


The analysis showed that there was a significant increase in knowledge and skills after giving the intervention (preceptorship learning methods about Leopold palpation.
CONCLUSION


Preceptorship learning methods can improve the knowledge and skills of Leopold palpation in student training for three midwifery diploma students.",2020,"The analysis showed that there was a significant increase in knowledge and skills after giving the intervention (preceptorship learning methods about Leopold palpation.
","['midwifery diploma students', '40 students', 'student training for three midwifery diploma students', 'School of Health Sciences Midwifery Plamonia VII Wirabuana Makassar Midwifery Study Program, conducted from September to October 2019']",['preceptorship learning methods'],"['knowledge and skills of Leopold palpation', 'knowledge and skills']","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}]",,0.0166671,"The analysis showed that there was a significant increase in knowledge and skills after giving the intervention (preceptorship learning methods about Leopold palpation.
","[{'ForeName': '', 'Initials': '', 'LastName': 'Sardillah', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia. Electronic address: sardillah@pasca.unhas.ac.id.'}, {'ForeName': 'Mardiana', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}, {'ForeName': 'Esther Sanda', 'Initials': 'ES', 'LastName': 'Manapa', 'Affiliation': 'Faculty of Marine Science and Fisheries, Hasanuddin University, Indonesia.'}, {'ForeName': 'Muh Nasrum', 'Initials': 'MN', 'LastName': 'Massi', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Veni', 'Initials': 'V', 'LastName': 'Hadju', 'Affiliation': 'Faculty of Medicine, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.171']
586,31773200,Effect of an exercise programme for reducing abdominal fat on overactive bladder symptoms in young overweight women.,"INTRODUCTION AND HYPOTHESIS


The effect of exercise in relation to overweight and overactive bladder (OAB) in young women has not been sufficiently supported by studies. The objective of our study was to reduce symptoms of OAB through a 3-month exercise programme in young overweight women with OAB. The sample consisted of 70 women (mean age 26.7 ± 4.8 years), 36 being treated and 34 in the control group.
METHODS


We used a body composition analyser with the assessment of skeletal muscle mass (SMM) (kg), body fat mass (BFM) (kg), body fat percentage (BFP) (%), visceral fat area (VFA) (cm²/level) and the waist/hip circumference index (WHR). OAB symptoms were evaluated using a voiding diary, the overactive bladder questionnaire (OAB-q) and the Patient Perception of Intensity of Urgency Scale (PPIUS). The intervention was a programme for the reduction of abdominal fat (PRAF), with elements of aerobic training, strengthening of the abdominal muscles and stretching.
RESULTS


In the OAB symptoms assessed through the voiding diary (number of voidings per 24 h, nocturia, mean voided volume) as well as in the OAB-q and PPIUS scales after training, significant differences were reported in favour of the treatment group [number of voidings per 24 h: treatment vs. control group, baseline 9.1 ± 0.3 vs. 8.6 ± 0.3, final 6.9 ± 0.2 vs. 8.1 ± 0.2, p < 0.0001; mean voided volume per 24 h (ml): treatment vs. control group, baseline 154.2 ± 9.1 vs. 162.2 ± 9.3, final 201.3 ± 9.3 vs. 164.1 ± 9.6, p < 0.0001] with a large effect size (ES). In the body composition analysis after training, significant differences were also reported in favour of the treatment group in the reduction of body mass index (BMI), BFP and VFA (p < 0.0001), with a large ES.
CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme. A reduction in OAB symptoms was also objectively confirmed following the PRAF exercise programme.",2020,"CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme.","['young overweight women', '70 women (mean age 26.7\u2009±\u20094.8\xa0years), 36 being treated and 34 in the control group', 'young overweight women with OAB', 'young women']","['exercise', 'aerobic training, strengthening of the abdominal muscles and stretching', 'exercise programme']","['OAB-q and PPIUS scales', 'BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference', 'reduction of body mass index (BMI), BFP and VFA', 'symptoms of OAB', 'overactive bladder symptoms', 'OAB symptoms assessed through the voiding diary (number of voidings per 24\xa0h, nocturia, mean voided volume', 'OAB symptoms', 'voiding diary, the overactive bladder questionnaire (OAB-q) and the Patient Perception of Intensity of Urgency Scale (PPIUS', 'skeletal muscle mass (SMM) (kg), body fat mass (BFM) (kg), body fat percentage (BFP) (%), visceral fat area (VFA) (cm²/level) and the waist/hip circumference index (WHR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0045933', 'cui_str': 'BFP'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}]",70.0,0.0334517,"CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme.","[{'ForeName': 'Magdaléna', 'Initials': 'M', 'LastName': 'Hagovska', 'Affiliation': 'Department of Physiatry, Balneology, and Medical Rehabilitation, Institution-Faculty of Medicine, PJ Safarik University, Rastislavova 43, 040 01, Kosice, Slovak Republic. magdalena.hagovska@upjs.sk.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Švihra', 'Affiliation': 'Department of Urology, Institution-Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Bratislava, Slovak Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Buková', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Dračková', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Horbacz', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Nagyová', 'Affiliation': 'Department of Social and Behavioural Medicine, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic.'}]",International urogynecology journal,['10.1007/s00192-019-04157-8']
587,31300288,"Persistence of immunity to conjugate and polysaccharide pneumococcal vaccines in frail, hospitalised older adults in long-term follow up.","BACKGROUND


Data on long-term antibody responses to pneumococcal vaccines in the elderly, especially the frail elderly at greatest risk of severe disease, are limited. We followed up participants in a randomised trial of the immunogenicity of 23-valent polysaccharide vaccine (23vPPV) and 7 valent pneumococcal conjugate vaccines (PCV7) in hospitalised older adults.
METHODS


We measured antibody to vaccine serotypes by standardised enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic (OPA) assays. A follow up study was conducted six years after vaccination with 23vPPV alone or with PCV7 followed by 23vPPV six months later.
RESULTS


Of 215 surviving trial participants, 136 (63%) completed follow up; 62 received 23vPPV and 74 received PCV7 + 23vPPV. There was no significant difference in death and readmission between arms. Antibody levels by ELISA and OPA did not differ significantly between the two study arms at 72 months post-vaccination. ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
DISCUSSION


While ELISA responses in both study arms remained high 6 years post-vaccination, considerable waning was observed by OPA in both study arms, which should be considered given the current single-dose recommendation in Australia. Further research is needed to inform pneumococcal vaccine recommendations in people over the age of 65.",2019,"ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
","['people over the age of 65', 'Of 215 surviving trial participants, 136 (63%) completed follow up', 'hospitalised older adults', 'frail, hospitalised older adults']","['23vPPV', 'PCV7\u202f+\u202f23vPPV', '23vPPV alone or with PCV7', 'polysaccharide pneumococcal vaccines', '23-valent polysaccharide vaccine (23vPPV) and 7 valent pneumococcal conjugate vaccines (PCV7']","['ELISA and OPA antibody', 'Antibody levels by ELISA and OPA', 'death and readmission']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0561056,"ELISA and OPA antibody remained higher than baseline except for OPA antibody to 4, 6A, 6B, 9v, 19F and 23F, including in subjects with undetectable immunity at baseline.
","[{'ForeName': 'C Raina', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'Biosecurity Program, Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address: r.macintyre@unsw.edu.au.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Ridda', 'Affiliation': 'Independent Scholar, Sydney, Australia.'}, {'ForeName': 'Mallory J', 'Initials': 'MJ', 'LastName': 'Trent', 'Affiliation': 'Biosecurity Program, Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address: mallory.trent@unsw.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McIntyre', 'Affiliation': 'National Centre for Immunisation Research and Surveillance, University of Sydney, Sydney, Australia. Electronic address: peter.mcintyre@sydney.edu.au.'}]",Vaccine,['10.1016/j.vaccine.2019.07.005']
588,30993537,The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial.,"PURPOSE


We compared the effects of benzydamine hydrochloride (BH), 10% lidocaine, and normal saline spray on preventing postoperative sore throat (POST) in patients who underwent total thyroidectomy (TT).
METHODS


In this prospective, randomized, parallel-group, double-blind study, the incidence of POST at six hours after tracheal extubation was compared among three groups as a primary outcome. American Society of Anesthesiologists physical status I-II patients undergoing elective TT under general anesthesia were enrolled. Patients were randomly stratified into group C (n = 33, normal saline), group L (n = 33, 10% lidocaine), or group B (n = 33, 0.3% BH). The participants, caregiver, and investigator were blinded to group assignment. Each study drug was sprayed three times on the endotracheal tube (ETT) cuff ten seconds before intubation. Incidence and severity of POST were recorded within 24 hr postoperatively (during postanesthesia care unit stay, and at six, 12, and 24 hr after extubation). P values were adjusted for multiple comparisons.
RESULTS


Ninety-nine patients were enrolled. Eighty-seven patients completed the study. The incidence of POST at six hours after tracheal extubation was similar among the three groups (group C: 31 [93.9%], group L: 29 [87.9%], and group B: 27 [81.8%]; P = 0.38). Nevertheless, the incidence of POST was significantly different among the three groups at 12 and 24 hr after TT (12 hr: P = 0.002, 24 hr: P = 0.01). The severity of POST after tracheal extubation was statistically different among the study groups (6 hr: P = 0.04, 12 hr: P = 0.01). No adverse effects were observed.
CONCLUSION


Application of BH spray on the ETT cuff reduced the incidence and severity of POST at 12 hr after TT. We suggest this method to be a non-invasive and effective management option for POST without serious side effects.
TRIAL REGISTRATION


Clinical Research Information Service (KCT0002627); registered 24 November, 2017.",2019,"The severity of POST after tracheal extubation was statistically different among the study groups (6 hr: P = 0.04, 12 hr: P = 0.01).","['American Society of Anesthesiologists physical status I-II patients undergoing elective TT under general anesthesia were enrolled', 'Ninety-nine patients were enrolled', 'patients who underwent total thyroidectomy (TT', 'Eighty-seven patients completed the study', 'postoperative sore throat after total thyroidectomy']","['benzydamine hydrochloride', 'benzydamine hydrochloride (BH), 10% lidocaine, and normal saline spray', 'endotracheal tube (ETT) cuff ten seconds before intubation', 'lidocaine', 'BH spray']","['severity of POST after tracheal extubation', 'postoperative sore throat (POST', 'Incidence and severity of POST', 'adverse effects', 'incidence and severity of POST', 'incidence of POST']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}]","[{'cui': 'C0282070', 'cui_str': 'Benzydamine Hydrochloride'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",99.0,0.209948,"The severity of POST after tracheal extubation was statistically different among the study groups (6 hr: P = 0.04, 12 hr: P = 0.01).","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Heejoon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Sehee', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Bobae', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Sangmin M', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. jiwon0715.choi@samsung.com.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01371-2']
589,30362878,Kinematic and Neuromuscular Adaptations in Incomplete Spinal Cord Injury after High- versus Low-Intensity Locomotor Training.,"Recent data demonstrate improved locomotion with high-intensity locomotor training (LT) in individuals with incomplete spinal cord injury (iSCI), although concerns remain regarding reinforcement of abnormal motor strategies. The present study evaluated the effects of LT intensity on kinematic and neuromuscular coordination in individuals with iSCI. Using a randomized, crossover design, participants with iSCI received up to 20 sessions of high-intensity LT, with attempts to achieve 70-85% of age-predicted maximum heart rate (HRmax), or low-intensity LT (50-65% HRmax), following which the other intervention was performed. Specific measures included spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings. Correlation analyses were conducted to evaluate associations between variables. Significant improvements in sagittal-plane joint excursions and intralimb hip-knee coordination were observed following high- but not low-intensity LT when comparing peak treadmill (TM) speed before and after LT. Neuromuscular complexity (i.e., number of synergies to explain >90% of EMG variance) was also increased following high- but not low-intensity LT. Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT. These findings suggest greater neuromuscular complexity may be due to LT and not necessarily differences in speeds. Only selected kinematic changes (i.e., weak hip excursion) was correlated to improvements in treadmill speed. In conclusion, LT intensity can facilitate gains in kinematic variables and neuromuscular synergies in individuals with iSCI.",2019,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","['individuals with incomplete spinal cord injury (iSCI', 'individuals with iSCI', 'participants with iSCI']","['intensity locomotor training (LT', 'High- versus Low-Intensity Locomotor Training']","['treadmill speed', 'neuromuscular complexity', 'sagittal-plane joint excursions and intralimb hip-knee coordination', 'spatiotemporal variables, sagittal-plane gait kinematics, and neuromuscular synergies from electromyographic (EMG) recordings', 'Neuromuscular complexity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.058473,"Comparison of speed-matched trials confirmed significant improvements in the knee excursion of the less impaired limb and intralimb hip-knee coordination, as well as improvements in neuromuscular complexity following high-intensity LT.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Seyed H', 'Initials': 'SH', 'LastName': 'Salehi', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': '2 Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': '1 Department of Physical Medicine and Rehabilitation, School of Medicine, Indiana University, Indianapolis, Indiana.'}]",Journal of neurotrauma,['10.1089/neu.2018.5900']
590,31880167,Compassion-focused self-help for psychological distress associated with skin conditions: a randomized feasibility trial.,"Objective:  This study tested the feasibility of a self-help intervention based on Compassion-Focused Theory (CFT), and estimated treatment effects in a population of adults with skin conditions and associated psychological distress. Design:  A randomized-controlled design was used, with 176 participants being allocated to either CFT-based self-help or a waitlist control group, who received usual medical care. The two-week intervention was provided by email. Main Outcome Measures:  Treatment adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion. Results:  Eighty-seven participants completed the post-intervention questionnaires (51%), and practiced on a median of 9/14 days. Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls. In intention-to-treat (ITT) analyses, these findings remained significant, however effect sizes reduced from moderate to small. Conclusions:  The findings indicate that CFT self-help shows promise in the treatment of psychological distress associated with skin conditions, however further testing of the intervention is not feasible without significant methodological changes, including the method of treatment delivery. Future studies should also include a follow-up period, as the duration of treatment effects could not be shown.",2020,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","['population of adults with skin conditions and associated psychological distress', '176 participants being allocated to either']","['Compassion-focused self-help', 'CFT-based self-help or a waitlist control group, who received usual medical care', 'self-help intervention based on Compassion-Focused Theory (CFT']","['post-intervention questionnaires', 'adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion', 'measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",87.0,0.0307342,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}]",Psychology & health,['10.1080/08870446.2019.1707829']
591,31233281,Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate.,"OBJECTIVE


To evaluate the long-term efficacy and safety of maintaining baricitinib monotherapy in patients with active rheumatoid arthritis (RA) originally treated with baricitinib monotherapy or switched from methotrexate (MTX) or the combination of baricitinib plus MTX to baricitinib monotherapy.
METHODS


This is a post hoc analysis of patients from the RA-BEGIN study who entered a long-term extension, RA-BEYOND, and were assessed for up to 24 weeks. In RA-BEGIN, MTX-naive patients with early active RA were randomized to MTX monotherapy, baricitinib 4 mg monotherapy, or baricitinib 4 mg plus MTX. At week 52, all patients entering RA-BEYOND received baricitinib 4 mg monotherapy. MTX could be prescribed during RA-BEYOND at the investigator's discretion.
RESULTS


Patients in RA-BEYOND who were not rescued in RA-BEGIN (n = 423) were evaluated. Of these, 47% continued baricitinib monotherapy and 53% added MTX, with similar proportions from the 3 original arms. Patients with lower disease activity at the RA-BEYOND baseline generally continued to do well with baricitinib monotherapy as assessed by the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the Health Assessment Questionnaire disability index scores. Patients prescribed MTX had higher disease activity at the RA-BEYOND baseline and had improved disease activity after the addition of MTX. Safety outcomes were similar across treatment groups.
CONCLUSION


Many patients responded well to continued baricitinib monotherapy or to switching to baricitinib monotherapy from MTX monotherapy or baricitinib plus MTX, showing sustained or improved disease control. The groups of patients who had less disease control on their original therapies showed sustained or improved disease control with the addition of MTX to baricitinib.",2020,"Safety outcomes were similar across treatment groups.
","['rheumatoid arthritis', 'naïve patients with early active RA', 'patients with active rheumatoid arthritis (RA']","['MTX monotherapy or baricitinib plus MTX', 'MTX monotherapy, baricitinib 4-mg monotherapy, or baricitinib 4-mg plus MTX', 'MTX', 'baricitinib plus MTX', 'baricitinib 4-mg monotherapy', 'baricitinib monotherapy or switched from methotrexate (MTX', 'baricitinib monotherapy', 'long-term baricitinib with and without methotrexate', 'methotrexate monotherapy or baricitinib plus methotrexate']","['Safety outcomes', 'sustained or improved disease control', 'Simplified Disease Activity Index, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores', 'Efficacy and safety', 'disease activity']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",423.0,0.0574468,"Safety outcomes were similar across treatment groups.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoykov', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lisse', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Pindaro', 'Initials': 'P', 'LastName': 'Martinez-Osuna', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}]",Arthritis care & research,['10.1002/acr.24007']
592,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES


Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO).
SUBJECTS/METHODS


Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant.
RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03).
CONCLUSION


In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS


Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7']
593,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
594,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
595,31800053,A Forced-Choice Procedure to Assess the Acute Relative Reinforcing Effects of Nicotine Dose per se in Humans.,"INTRODUCTION


A method to assess acute reinforcement due to nicotine may aid identification of doses needed to maintain dependence. After describing development of a forced-choice procedure, results are presented from two studies using it to determine the relative reinforcing effects of nicotine dose per se.
AIMS AND METHODS


Choice between a higher versus a very low or no nicotine option, via smoking (Study 1, n = 59) and via nasal spray (Study 2, n = 42), was assessed in nontreatment-seeking dependent smokers abstinent overnight. Using a within-subject design, different nicotine levels for each product were administered under blind conditions, initially to assess their discriminability (Study 1: 1.3-17 mg/g each vs. 0.4 mg/g nicotine Spectrum cigarettes; Study 2: 2.5 µg/kg vs. 0 µg/kg nicotine per spray). At the end of sessions for each study, participants engaged in forced-choice trials to assess preference, requiring a fixed number of puffs/sprays for one and/or the other.
RESULTS


Confirming the procedure's validity, the choice of the higher nicotine option was significantly greater than that for the very low or no nicotine option in both studies. In Study 1, choice relative to 0.4 mg/g was greater for cigarettes 5.3 mg/g or more but not 2.3 mg/g or less (p = .003 for the interaction of higher content vs. 0.4 mg/g comparison). In Study 2, choice was greater for the nicotine versus placebo spray (p < .005), as nicotine was preferred nearly twice as much as the placebo.
CONCLUSION


This forced-choice procedure may efficiently determine the relative reinforcing value of a nicotine dose per se.
IMPLICATIONS


The forced-choice procedure described here may identify nicotine doses that are acutely reinforcing in dependent smokers. A priori research of choice comparisons between small versus zero nicotine doses could inform clinical research in larger and more diverse samples to determine nicotine contents in cigarettes, and perhaps in other commercial products, that are not reinforcing and, thus, likely to reduce the risk of their addictiveness. This procedure may also be applicable to assessing changes in acute nicotine reinforcement due to different product formulations, novel drugs, or other manipulations, perhaps helping inform development of new interventions for cessation or harm reduction.",2020,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","['Humans', 'Choice between a higher vs. a very low or no nicotine option, via smoking (Study 1, n=59) and via nasal spray (Study 2, n=42), were assessed in non-treatment seeking dependent smokers abstinent overnight']","['placebo', 'nicotine vs. placebo', 'Nicotine', 'nicotine']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",[],,0.13249,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz224']
596,31233269,Effects of Message Framing on Patients' Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch.,"OBJECTIVE


Patients often hold negative perceptions toward biosimilars that can create barriers to their uptake. Physicians also report uncertainty in how best to explain biosimilars. The aim of this study was to measure the effect of differently framed explanations on patients' perceptions of and willingness to change to a biosimilar in a hypothetical drug switch.
METHODS


Ninety-six patients with rheumatic diseases taking an originator biologic were randomized to receive 1 of 4 biosimilar explanations: positive framing with and without an analogy, and negative framing with and without an analogy. Willingness to switch to a biosimilar, perceptions about biosimilars, and the effectiveness of the explanation were measured after the information delivery.
RESULTS


Positive framing led to more participants being willing to switch (67%) than negative framing (46%). Framing significantly predicted willingness to switch to a biosimilar, with participants in the positive framing group being 2.36 times more willing to switch (P = 0.041). The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046) and thought the explanation was more convincing (P = 0.030). The analogy did not enhance willingness to switch or increase understanding (P > 0.05).
CONCLUSION


Positive framing can improve perceptions of and willingness to switch to a biosimilar in patients currently taking biologic treatments.",2020,"The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046), and thought the explanation was more convincing (P = 0.030).",['Ninety-six patients with rheumatic diseases taking an originator biologic'],"['biosimilar explanations - positive framing with and without an analogy, and negative framing with and without an analogy']",['efficacy of biosimilars'],"[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}]",96.0,0.0527785,"The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046), and thought the explanation was more convincing (P = 0.030).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gasteiger', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Annie S K', 'Initials': 'ASK', 'LastName': 'Jones', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'University of Auckland, Auckland, and University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lobo', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Auckland District Health Board and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}]",Arthritis care & research,['10.1002/acr.24012']
597,30831308,Impact of hypnosis on patient experience after venous access port implantation.,"INTRODUCTION


Hypnosis has been reported to decrease pain and anxiety in surgical context, but data studying its impact on patient experience using a validated scale are scarce. In the present study, we assessed the effect of an audio hypnosis session on patient satisfaction during venous access port implantation under local anaesthesia in adult cancer patients using the EVAN-LR Score.
METHODS


After informed consent, patients were randomised to receive either hypnosis or standard care. The hypnosis group listened to a 26 minutes recorded audio hypnosis session through the ongoing implantation procedure. The primary outcome was the result of the EVAN-LR questionnaire, assessing perioperative experience in patients undergoing anaesthesia without loss of consciousness. This score describes a global index and 5 dimensions of experience: comfort, pain attention, information and waiting. It is scaled from 0 to 100 with 100 indicating the best possible level of satisfaction. Secondary outcomes included patient's anxiety, heart rate before and after procedure, procedure duration and several Visual Analogic Scale to match EVAN-LR dimensions.
RESULTS


Overall, 148 patients were enrolled in the study. The global index of Evan-LR was significantly higher in the hypnosis session group (78 ± 14) compared to the standard care group (71 ± 17) (P = 0.006). No difference was reported in secondary outcomes.
CONCLUSION


A recorded audio hypnosis session during subcutaneous venous port implantation under local anaesthesia in cancer patients significantly improved patient satisfaction.",2019,The global index of Evan-LR was significantly higher in the hypnosis session group (78 ± 14) compared to the standard care group (71 ± 17) (P = 0.006).,"['148 patients were enrolled in the study', 'patients undergoing anaesthesia without loss of consciousness', 'adult cancer patients using the EVAN-LR Score', 'patient experience after venous access port implantation']","['hypnosis', 'audio hypnosis session', 'hypnosis or standard care', 'hypnosis group listened to a 26\u2009minutes recorded audio hypnosis session through the ongoing implantation procedure']","['global index and 5 dimensions of experience: comfort, pain attention, information and waiting', 'result of the EVAN-LR questionnaire, assessing perioperative experience', ""patient's anxiety, heart rate before and after procedure, procedure duration and several Visual Analogic Scale to match EVAN-LR dimensions"", 'pain and anxiety', 'global index of Evan-LR', 'patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0041657', 'cui_str': 'Unconscious State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",148.0,0.0815185,The global index of Evan-LR was significantly higher in the hypnosis session group (78 ± 14) compared to the standard care group (71 ± 17) (P = 0.006).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hoslin', 'Affiliation': 'Department of anaesthesia, Gustave-Roussy Institute, 39, rue Camille-Demoulins, Villejuif, France.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Motamed', 'Affiliation': 'Department of anaesthesia, Gustave-Roussy Institute, 39, rue Camille-Demoulins, Villejuif, France. Electronic address: cyrus.motamed@gustaveroussy.fr.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Maurice-Szamburski', 'Affiliation': 'Department of anaesthesia and intensive care, Hôpital La Timone, Marseille, France.'}, {'ForeName': 'Clemence', 'Initials': 'C', 'LastName': 'Legoupil', 'Affiliation': 'Department of Biostatistics and epidemiology, Gustave-Roussy Institute, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pons', 'Affiliation': 'Department of anaesthesia, Gustave-Roussy Institute, 39, rue Camille-Demoulins, Villejuif, France.'}, {'ForeName': 'Lauriane', 'Initials': 'L', 'LastName': 'Bordenave', 'Affiliation': 'Department of anaesthesia, Gustave-Roussy Institute, 39, rue Camille-Demoulins, Villejuif, France.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2019.02.013']
598,31813633,"Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH.
METHODS


In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6.
FINDINGS


Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group).
INTERPRETATION


Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes.
FUNDING


Intercept Pharmaceuticals.",2019,"The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group).
","['non-alcoholic steatohepatitis', '1968 patients with stage', 'adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity', 'F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the', '1968 patients with fibrosis stages F1-F3', 'patients with NASH', 'Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present']","['obeticholic acid', 'placebo', 'oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily', 'Obeticholic acid', 'obeticholic acid 10 mg group, and 308 in the obeticholic acid']","['histological and biochemical markers of NASH and fibrosis, and safety', 'overall safety profile', 'serious adverse events', 'NASH resolution endpoint', 'fibrosis improvement endpoint', 'fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4271802', 'cui_str': 'obeticholic acid 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",931.0,0.650406,"The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group).
","[{'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Ratziu', 'Affiliation': 'Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute for Cardiometabolism and Nutrition, Paris, France.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Rsearch Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Quentin M', 'Initials': 'QM', 'LastName': 'Anstee', 'Affiliation': 'The Newcastle Liver Research Group, Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bedossa', 'Affiliation': ""Service d'Anatomie Pathologique, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Geier', 'Affiliation': 'Department of Hepatology, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Beckebaum', 'Affiliation': 'St Josef-Krankenhaus Kupferdreh, Essen, Germany.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK; Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Institute of Translational & Stratified Medicine, University of Plymouth and University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Muhammad Y', 'Initials': 'MY', 'LastName': 'Sheikh', 'Affiliation': 'Fresno Clinical Research Center, Fresno, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Trotter', 'Affiliation': 'Baylor Health, Liver Consultants of Texas, Dallas, TX, USA.'}, {'ForeName': 'Whitfield', 'Initials': 'W', 'LastName': 'Knapple', 'Affiliation': 'Arkansas Gastroenterology, North Little Rock, AR, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Swedish Liver Center, Seattle, WA, USA.'}, {'ForeName': 'Aldo J', 'Initials': 'AJ', 'LastName': 'Montano-Loza', 'Affiliation': 'Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Boursier', 'Affiliation': 'HIFIH Laboratory, UPRES EA3859, SFR 4208, Angers University, Angers, France; Hepato-Gastroenterology Department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Mathurin', 'Affiliation': 'Hepato-gastroenterology, CHU Lille, Lille, France.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Bugianesi', 'Affiliation': 'Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mazzella', 'Affiliation': 'Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Olveira', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Cortez-Pinto', 'Affiliation': 'Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Graupera', 'Affiliation': ""Liver Unit, Hospital Clínic de Barcelona, Barcelona, Spain; Institut D'investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Orr', 'Affiliation': 'New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Lise Lotte', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'The Gastrounit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Dufour', 'Affiliation': 'University Clinic for Visceral Surgery and Medicine, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Campagna', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Luna', 'Initials': 'L', 'LastName': 'Zaru', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Clinical Research Center, San Antonio, TX, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: arun.sanyal@vcuhealth.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)33041-7']
599,31282418,Can Adults with Mild Cognitive Impairment Build Cognitive Reserve and Learn Mindfulness Meditation? Qualitative Theme Analyses from a Small Pilot Study.,"BACKGROUND/OBJECTIVE


High levels of chronic stress negatively impact the hippocampus and are associated with increased incidence of mild cognitive impairment (MCI) and Alzheimer's disease. While mindfulness meditation may mitigate the effects of chronic stress, it is uncertain if adults with MCI have the capacity to learn mindfulness meditation.
METHODS


14 adults with MCI were randomized 2:1 to Mindfulness Based Stress Reduction (MBSR) or a wait-list control group. We conducted qualitative interviews with those who completed MBSR. Transcribed interviews were: a) coded using an emergent themes inductive approach informed by grounded theory; b) rated 0-10, with higher scores reflecting greater perceived benefit from, and understanding of, mindfulness meditation. Ratings were correlated with daily home practice times and baseline level of cognitive function.
RESULTS


Seven themes emerged from the interviews: positive perceptions of class; development of mindfulness skills, including meta-cognition; importance of the group experience; enhanced well-being; shift in MCI perspective; decreased stress reactivity and increased relaxation; improvement in interpersonal skills. Ratings of perceived benefit and understanding ranged from 2-10 (mean = 7) and of 0-9.5 (mean = 6), respectively. Many participants experienced substantial benefit/understanding, some had moderate, and a few had minimal benefit/understanding. Understanding the key concepts of mindfulness was highly positively correlated with ≥20 minutes/day of home practice (r = 0.90) but not with baseline cognitive function (r = 0.13).
CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement. Cognitive reserve may be enhanced through a mindfulness meditation program even in patients with MCI.",2019,"CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement.","['14 adults with MCI', 'patients with MCI']",['Mindfulness Based Stress Reduction (MBSR) or a wait-list control group'],"['Cognitive reserve', 'positive perceptions of class; development of mindfulness skills, including meta-cognition; importance', 'daily home practice times and baseline level of cognitive function', 'MCI acceptance, self-efficacy, and social engagement', 'stress reactivity and increased relaxation; improvement in interpersonal skills']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2936352', 'cui_str': 'Brain Reserve'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589513', 'cui_str': 'Meta-cognition'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}]",14.0,0.0172474,"CONCLUSIONS


Most adults with MCI were able to learn mindfulness meditation and had improved MCI acceptance, self-efficacy, and social engagement.","[{'ForeName': 'Rebecca Erwin', 'Initials': 'RE', 'LastName': 'Wells', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kerr', 'Affiliation': 'Department of Family Medicine and Mindfulness-Wellness Program, Brown University School of Medicine, Providence, RI, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Dossett', 'Affiliation': 'Department of Medicine and Benson-Henry Institute for Mind Body Medicine, Division of General Internal Medicine, Massachusetts General Hospital; and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Danhauer', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Sohl', 'Affiliation': 'Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Bonnie C', 'Initials': 'BC', 'LastName': 'Sachs', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jacquelyn Walsh', 'Initials': 'JW', 'LastName': 'Feeley', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wolkin', 'Affiliation': 'BrainCurves, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wall', 'Affiliation': 'Mclean Hospital Borden Cottage, Camden, ME, USA.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Kaptchuk', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Press', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Phillips', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190191']
600,31781836,"'Intermittent' versus 'continuous' ScvO 2  monitoring in children with septic shock: a randomised, non-inferiority trial.","PURPOSE


To compare the effect of 'intermittent' central venous oxygen saturation (ScvO 2 ) monitoring with 'continuous' ScvO 2  monitoring on shock resolution and mortality in children with septic shock.
METHODS


Primary outcome was the achievement of therapeutic goals or shock resolution in the first 6 h. We randomly assigned children < 17 years' age with septic shock to 'intermittent ScvO 2 ' or 'continuous ScvO 2 ' groups. All children were subjected to subclavian/internal jugular line insertion and managed as per Surviving Sepsis Campaign Guidelines. To guide resuscitation, we used ScvO 2  estimated at other clinical and laboratory parameters were monitored similarly in both groups.
RESULTS


We enrolled 75 and 77 children [median (IQR) age: 6 (1.5-10) years] in the 'intermittent' and 'continuous' groups, respectively. Baseline characteristics were comparable between the groups. When compared to the 'continuous' group, fewer children in the 'intermittent' group achieved shock resolution within first 6 h [19% vs. 36%; relative risk (RR) 0.51; 95% CI 0.29-0.89; risk difference - 18.0%; 95% CI - 32.0 to - 4.0]. The lower bound of confidence interval, however, crossed the pre-specified non-inferiority margin. There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
CONCLUSIONS


Given that a greater proportion of children attained therapeutic end points in the first 6 h, continuous monitoring of ScvO 2  should preferably be used to titrate therapy in the first few hours in children with septic shock. In the absence of such facility, intermittent monitoring of ScvO 2  can be used to titrate therapy in these children, given the lack of difference in the proportion of patients achieving shock resolution at 24 h or in risk of mortality between the intermittent and continuous groups.",2020,"There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
","[""We enrolled 75 and 77 children [median (IQR) age: 6 (1.5-10) years] in the 'intermittent' and 'continuous' groups, respectively"", 'children with septic shock', ""randomly assigned children\u2009<\u200917\xa0years' age with septic shock to 'intermittent ScvO 2 ' or 'continuous ScvO 2 ' groups""]","[""Intermittent' versus 'continuous' ScvO 2  monitoring"", ""intermittent' central venous oxygen saturation (ScvO 2 ) monitoring with 'continuous' ScvO 2  monitoring"", 'subclavian/internal jugular line insertion']","['proportion of children attaining shock resolution', 'achievement of therapeutic goals or shock resolution in the first 6\xa0h', 'shock resolution and mortality', 'shock resolution', 'risk of mortality']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0589488', 'cui_str': 'Subclavicular approach (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.206973,"There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
","[{'ForeName': 'Jhuma', 'Initials': 'J', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. jhumaji@gmail.com.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushil Kumar', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Intensive care medicine,['10.1007/s00134-019-05858-w']
601,31571243,Effects of non-surgical periodontal therapy on inflammatory markers of psoriasis: A randomized controlled trial.,"AIM


The purpose of this randomized controlled clinical study was to evaluate the effect of non-surgical mechanical periodontal therapy on the inflammatory status and severity of psoriasis in subjects with psoriasis.
MATERIAL AND METHODS


The study population consisted of 92 periodontitis patients with psoriasis vulgaris suffering from an untreated periodontal disease. Two randomized groups were formed from these patients: immediate periodontal therapy (test group, n = 46) and delayed periodontal therapy (control group, n = 46). Periodontal clinical measures, on salivary interleukin 2, interleukin 6 and secretory immunoglobulin A levels and the Psoriasis Area and Severity Index (PASI) scores were evaluated at baseline and on the 8th week in control and test groups.
RESULTS


Eight weeks after completion of non-surgical periodontal therapy (test group) or initial examination (control group), a significant decrease was observed in interleukin 2, interleukin 6 level and in PASI score, whereas a significant increase was observed in secretory immunoglobulin A levels in the test group (p < .05).
CONCLUSION


Within the limits of this study, the results suggest that effective periodontal therapy improves the psoriasis condition in patients afflicted by both diseases.",2020,"Periodontal clinical measures, on salivary interleukin 2, interleukin 6 and secretory immunoglobulin A levels and the Psoriasis Area and Severity Index (PASI) scores were evaluated at baseline and on the 8th week in control and test groups.
","['92 periodontitis patients with psoriasis vulgaris suffering from an untreated periodontal disease', 'subjects with psoriasis']","['delayed periodontal therapy', 'Immediate periodontal therapy', 'initial examination (control group', 'non-surgical periodontal therapy', 'non-surgical mechanical periodontal therapy']","['psoriasis condition', 'salivary interleukin 2, interleukin 6 and secretory immunoglobulin A levels and the Psoriasis Area and Severity Index (PASI) scores', 'secretory immunoglobulin A levels', 'interleukin 2, interleukin 6 level and in PASI score', 'inflammatory markers of psoriasis', 'inflammatory status and severity of psoriasis']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris (disorder)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",92.0,0.0371586,"Periodontal clinical measures, on salivary interleukin 2, interleukin 6 and secretory immunoglobulin A levels and the Psoriasis Area and Severity Index (PASI) scores were evaluated at baseline and on the 8th week in control and test groups.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ucan Yarkac', 'Affiliation': 'Faculty of Dentistry, Periodontology, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Atiye', 'Initials': 'A', 'LastName': 'Ogrum', 'Affiliation': 'Faculty of Medicine, Dermatology and Venereology, Gaziosmanpasa University, Tokat, Turkey.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Gokturk', 'Affiliation': 'Faculty of Dentistry, Periodontology, Bolu Abant Izzet Baysal University, Bolu, Turkey.'}]",Journal of clinical periodontology,['10.1111/jcpe.13205']
602,31679946,"Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.","BACKGROUND


Cystic fibrosis transmembrane conductance regulator (CFTR) modulators correct the basic defect caused by CFTR mutations. Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation. The addition of elexacaftor (VX-445), a next-generation CFTR corrector, to tezacaftor plus ivacaftor further improved F508del-CFTR function and clinical outcomes in a phase 2 study in people with cystic fibrosis homozygous for the F508del mutation.
METHODS


This phase 3, multicentre, randomised, double-blind, active-controlled trial of elexacaftor in combination with tezacaftor plus ivacaftor was done at 44 sites in four countries. Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive. After a 4-week tezacaftor plus ivacaftor run-in period, participants were randomly assigned (1:1) to 4 weeks of elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h alone. The primary outcome was the absolute change from baseline (measured at the end of the tezacaftor plus ivacaftor run-in) in ppFEV 1  at week 4. Key secondary outcomes were absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score. This study is registered with ClinicalTrials.gov, NCT03525548.
FINDINGS


Between Aug 3 and Dec 28, 2018, 113 participants were enrolled. Following the run-in, 107 participants were randomly assigned (55 in the elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor group) and completed the 4-week treatment period. The elexacaftor plus tezacaftor plus ivacaftor group had improvements in the primary outcome of ppFEV 1  (least squares mean [LSM] treatment difference of 10·0 percentage points [95% CI 7·4 to 12·6], p<0·0001) and the key secondary outcomes of sweat chloride concentration (LSM treatment difference -45·1 mmol/L [95% CI -50·1 to -40·1], p<0·0001), and CFQ-R RD score (LSM treatment difference 17·4 points [95% CI 11·8 to 23·0], p<0·0001) compared with the tezacaftor plus ivacaftor group. The triple combination regimen was well tolerated, with no discontinuations. Most adverse events were mild or moderate; serious adverse events occurred in two (4%) participants receiving elexacaftor plus tezacaftor plus ivacaftor and in one (2%) receiving tezacaftor plus ivacaftor.
INTERPRETATION


Elexacaftor plus tezacaftor plus ivacaftor provided clinically robust benefit compared with tezacaftor plus ivacaftor alone, with a favourable safety profile, and shows the potential to lead to transformative improvements in the lives of people with cystic fibrosis who are homozygous for the F508del mutation.
FUNDING


Vertex Pharmaceuticals.",2019,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"['107 participants were randomly assigned (55 in the', 'Between Aug 3 and Dec 28, 2018, 113 participants were enrolled', 'Eligible participants were those with cystic fibrosis homozygous for the F508del mutation, aged 12 years or older with stable disease, and with a percentage predicted forced expiratory volume in 1 s (ppFEV 1 ) of 40-90%, inclusive', 'people with cystic fibrosis homozygous for the F508del mutation', 'people with cystic fibrosis who are homozygous for the F508del mutation']","['elexacaftor plus tezacaftor plus ivacaftor group and 52 in the tezacaftor plus ivacaftor', 'elexacaftor', 'tezacaftor plus ivacaftor', 'elexacaftor (VX-445', 'elexacaftor 200 mg orally once daily plus tezacaftor 100 mg orally once daily plus ivacaftor 150 mg orally every 12 h versus tezacaftor 100 mg orally once daily plus ivacaftor', 'elexacaftor plus tezacaftor plus ivacaftor combination regimen']","['adverse events', 'ppFEV 1  (least squares mean [LSM] treatment difference of 10·0 percentage points', 'Efficacy and safety', 'sweat chloride concentration (LSM treatment difference -45·1 mmol/L', 'absolute change in sweat chloride and Cystic Fibrosis Questionnaire-Revised respiratory domain (CFQ-R RD) score', 'CFQ-R RD score']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4550902', 'cui_str': 'tezacaftor 100 MG'}, {'cui': 'C3264622', 'cui_str': 'ivacaftor 150 MG'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",113.0,0.337851,Improvements in health outcomes have been achieved with the combination of a CFTR corrector and potentiator in people with cystic fibrosis homozygous for the F508del mutation.,"[{'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: h.g.m.heijerman@umcutrecht.nl.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""St Vincent's University Hospital and University College Dublin School of Medicine, Dublin, Ireland.""}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""Division of Respirology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': 'Department of Pulmonology, Immunology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Center for Lung Research, Berlin, Germany.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Welter', 'Affiliation': 'Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington School of Medicine, Seattle, WA, USA.""}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'McKee', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Sosnay', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Simard', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Yaohua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Vertex Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': 'Department of Medicine and Pediatrics, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'McCoy', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Ohio State University, Columbus, OH, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32597-8']
603,31537443,"Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials.","BACKGROUND


Herpes zoster (HZ) risk appears to vary by sex and geographic ancestry/ethnicity.
METHODS


In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart. In this post-hoc analysis, we investigate efficacy of RZV against HZ and postherpetic neuralgia (PHN) by sex, geographic region, and geographic ancestry/ethnicity in ≥50-year-olds (ZOE-50: NCT01165177) and ≥70-year-olds (pooled data from ZOE-50 and ZOE-70: NCT01165229).
RESULTS


Vaccine efficacy against HZ or PHN was similar in women and men. Across geographic regions, efficacy against HZ ranged between 95.7 and 97.2% in ≥50-year-olds, and between 87.3% and 95.1% in ≥70-year-olds; efficacy against PHN ranged between 86.8 and 100% in ≥70-year-olds. Across ancestral/ethnic groups, efficacy ranged between 88.1 and 100% against HZ and between 65.9 and 100% against PHN in ≥70-year-olds.
CONCLUSIONS


While the ZOE-50/70 studies were not powered or pre-designed for these post-hoc analyses, RZV appears efficacious against HZ and PHN irrespective of sex, region, or geographic ancestry/ethnicity.",2019,"In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart.",['women and men'],"['adjuvanted recombinant zoster vaccine (RZV', 'RZV', 'adjuvanted recombinant zoster vaccine (RZV) or placebo']",['efficacy against HZ'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.298751,"In 2 randomized clinical trials, participants received 2 doses of adjuvanted recombinant zoster vaccine (RZV) or placebo intramuscularly, 2 months apart.","[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Willer', 'Affiliation': 'GSK, 7333 Mississauga Rd., Mississauga, Ontario, Canada. Electronic address: david.o.willer@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Cunningham', 'Affiliation': 'The Westmead Institute for Medical Research, 176 Hawkesbury Rd, Westmead, NSW 2145, Australia; University of Sydney, 133 Castlereagh St, Sydney, NSW 2000, Australia. Electronic address: tony.cunningham@sydney.edu.au.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gervais', 'Affiliation': 'Q&T Research Sherbrooke Inc, 2185 King W, Sherbrooke, Quebec, Canada. Electronic address: pierre.gervais@qtresearch.com.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Gorfinkel', 'Affiliation': 'PrimeHealth Clinical Research, 1849 Yonge Street, Suite 516, Toronto, Ontario, Canada. Electronic address: i.gor@outlook.com.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Hyung Kim', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: joon-hyung.k.kim@gsk.com.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Talarico', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: carla.a.talarico@gsk.com.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Wascotte', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: valentine.v.wascotte@gsk.com.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium. Electronic address: toufik.zahaf@gsk.com.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Colindres', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: romcolindres@hotmail.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: anne.a.schuind@gsk.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.09.028']
604,31169350,Determination of optimal on-treatment diastolic blood pressure range using automated measurements in subjects with cardiovascular disease-Analysis of a SPRINT trial subpopulation.,"Automated office blood pressure measurement (AOBPM) is recommended for diagnosing hypertension; however, optimal treatment targets using this method are not established. Discrepancies between automated and office measurements of blood pressure have been described, producing uncertainty regarding the use of AOBPM in clinical practice. The Systolic Blood Pressure Intervention Trial (SPRINT) results improved our understanding of target AOBPM systolic blood pressure (SBP) levels; however, diastolic blood pressure (DBP) targets remain unknown. Therefore, we sought to determine the optimal on-treatment DBP range. The analysis was performed on the participants of the SPRINT trial who had hypertension and prior cardiovascular disease. We analyzed the data of 1470 participants (mean age 70.3 ± 9.3 years, 24.1% female) selected from the SPRINT trial database of National Heart, Lung and Blood Institute. The mean achieved SBP and DBP were 127.9 ± 10.7 and 68.3 ± 9.4 mm Hg, respectively. Most of the participants (57.4%) had a DBP lower than 70 mm Hg, while only 11.7% had DPB ≥80 mm Hg. Clinical composite endpoint was defined as myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure or death from cardiovascular causes. There were 159 (10.8%) clinical endpoint events. The participants with on-treatment AOBPM DBP range of 68.6-78.6 mm Hg showed the lowest hazard risk of a clinical composite endpoint. These results correspond to the office DBP range of 70-80 mm Hg recommended in ESC guidelines. This is the first attempt to determine the range of optimal DBP values using population-based AOBPM in patients with prior cardiovascular disease.",2019,Hg showed the lowest hazard risk of a clinical composite endpoint.,"['participants of the SPRINT trial who had hypertension and prior cardiovascular disease', '1470 participants (mean age 70.3\xa0±\xa09.3\xa0years, 24.1% female) selected from the SPRINT trial database of National Heart, Lung and Blood Institute', 'participants with on-treatment AOBPM DBP range of 68.6-78.6\xa0mm', 'subjects with cardiovascular disease-Analysis of a SPRINT trial subpopulation', 'patients with prior cardiovascular disease']",['Automated office blood pressure measurement (AOBPM'],"['diastolic blood pressure (DBP', 'DBP', 'mean achieved SBP and DBP', 'myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure or death from cardiovascular causes', 'AOBPM systolic blood pressure (SBP) levels']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0005768'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517855', 'cui_str': '68.6 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1470.0,0.0637285,Hg showed the lowest hazard risk of a clinical composite endpoint.,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sobieraj', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Siński', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13581']
605,31175711,Short-term effects of perindopril-amlodipine vs perindopril-indapamide on blood pressure control in sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension: A double-blinded randomized controlled trial.,"Poor blood pressure (BP) control contributes to complications in sub-Saharan African (SSA) type 2 diabetic individuals. Experts have advocated the use of combination therapies for effective BP control in these patients. The suggested combinations should include a RAAS antagonist and either a CCB or a thiazide diuretic; however, their efficacy is yet to be established in SSA. We investigated the short-term effects of two combination therapies on BP control in SSA type 2 diabetic individuals. This was a double-blinded randomized controlled trial conducted at the Yaoundé Central Hospital (Cameroon) from October 2016 to May 2017. We included type 2 diabetic patients, newly diagnosed for hypertension. After baseline assessment and 24-hour ABPM, participants were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days. Data analyses followed the intention-to-treat principle. We included fifteen participants (8 being females) in each group. Both combinations provided good circadian BP control after 6 weeks with similar efficacy. Twenty-four-hour SBP dropped from 144 to 145 mm Hg vs 128 to 126 mm Hg with perindopril-amlodipine and perindopril-indapamide, respectively (P = 0.003 for both groups). Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups. No significant adverse effect was reported. A fixed initial combination of perindopril-amlodipine or perindopril-indapamide achieved similar effective BP control after 6 weeks in SSA type 2 diabetic individuals with newly diagnosed hypertension. Therefore, these combinations can be used interchangeably in this indication.",2019,Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups.,"['sub-Saharan African (SSA) type 2 diabetic individuals', 'type 2 diabetic patients, newly diagnosed for hypertension', 'Yaoundé Central Hospital (Cameroon) from October 2016 to May 2017', 'fifteen participants (8 being females) in each group', 'Hg vs 128 to 126\xa0mm', 'SSA type 2 diabetic individuals', 'sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension', 'SSA type 2 diabetic individuals with newly diagnosed hypertension']","['perindopril-amlodipine and perindopril-indapamide', 'perindopril-amlodipine vs perindopril-indapamide', 'perindopril\xa0+\xa0amlodipine or perindopril\xa0+\xa0indapamide', 'perindopril-amlodipine or perindopril-indapamide']","['blood pressure control', 'Poor blood pressure (BP', 'adverse effect', 'effective BP control']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",15.0,0.426857,Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups.,"[{'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Sobngwi', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Mfeukeu-Kuate', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Merveille', 'Initials': 'M', 'LastName': 'Kouam', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Aurel T', 'Initials': 'AT', 'LastName': 'Tankeu', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Nganou-Gnindjio', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Ba', 'Initials': 'B', 'LastName': 'Hamadou', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Etoa', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Ngassam', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nkamgna', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Mesmin Y', 'Initials': 'MY', 'LastName': 'Dehayem', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'François F', 'Initials': 'FF', 'LastName': 'Kaze', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Andre P', 'Initials': 'AP', 'LastName': 'Kengne', 'Affiliation': 'Non-Communicable Diseases Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Mbanya', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13557']
606,31268369,Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis.,"Background:  Tildrakizumab is a high-affinity, humanized, IgG1 κ, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis. Objectives:  This analysis examined whether tildrakizumab's week-28 efficacy can be sustained or improved to week 52. Methods:  Psoriasis patients on the same-dose tildrakizumab (100 or 200 mg) in the first 52 weeks achieving week-28 PASI ≥50 were pooled from two phase-3 randomized controlled trials, and grouped into four mutually exclusive week-28 PASI response groups. Patients' week-52 PASI responses were compared to their week-28 PASI responses. Results:  Of 352 patients receiving 100-mg tildrakizumab, 10.5%, 25.3%, 38.4%, and 25.9% achieved PASI 50-74, 75-89, 90-99, and 100 at week 28, respectively. Among patients achieving PASI ≥90, ≥75, or ≥50 at week 28, 89.4%, 91.1%, or 97.4% maintained their week-28 PASI responses at week 52, respectively. Among patients achieving PASI 50-74, 75-89, or 90-99 at week 28, 64.8%, 33.7%, or 25.2% improved their week-28 PASI responses at week 52, respectively. Limitations:  This post hoc analysis may be less robust than an a priori analysis. Conclusions:  Most tildrakizumab-treated patients with week-28 PASI ≥75 maintained their week-28 PASI improvement at week 52. More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52.  Clinicaltrials.gov identifiers:  NCT01722331, NCT01729754.",2020,More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52.,"['Patients with Moderate-to-Severe Plaque Psoriasis', '100 or 200\u2009mg) in the first 52 weeks achieving week-28 PASI ≥50', '352 patients receiving']","['100-mg tildrakizumab', 'tildrakizumab', 'Tildrakizumab']","['week-28 PASI responses', 'PASI responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",352.0,0.0466796,More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52.,"[{'ForeName': 'Boni', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': 'Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White, Dallas, TX, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Crowley', 'Affiliation': 'Bakersfield Dermatology, Bakersfield, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lowry', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rozzo', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceuticals, Princeton, NJ, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1640348']
607,31798941,An iterative design process to develop a randomized feasibility study and inform recruitment of minority women after stillbirth.,"Background


Yearly, approximately 25,000 US women experience stillbirth and African American women have a 2.2 fold increased risk of stillbirth compared with white women. After stillbirth, women are subject to a sevenfold increased risk of post-traumatic stress compared with women after a live-birth. This paper presents findings from phase one of a National Institutes of Health funded, two-phase feasibility study to examine an online yoga intervention to reduce symptoms of post-traumatic stress in mothers after stillbirth. An iterative design was used to (1) inform the development of the online yoga intervention and (2) inform recruitment strategies to enroll minority women into phase two.
Methods


Ten mothers ( N  = 5 stillbirth moms with no yoga experience,  N  = 5 nonstillbirth moms with yoga experience) participated in a series of online yoga videos ( N  = 30) and were assessed for self-compassion (SC) and emotional regulation (ER) before and after each video. An independent group of five minority women who had experienced stillbirth were interviewed about cultural barriers to recruitment and perceptions/opinions of yoga. A mean was calculated for SC and ER scores for each video at pre- and post-time points. The percent change of the mean difference between pre-post SC and ER scores were used to select videos for phase two. Videos with a negative change score or that had a 0% change on SC or ER were not used. A combination of deductive and inductive coding was used to organize the interview data, generate categories, and develop themes.
Results


Five of the 30 tested yoga videos were not used. An additional 12 videos were developed, filmed, and used in the prescription for phase two. Topics from interview findings included perceived benefits/barriers of and interest in yoga, preferred yoga environment, suggested recruitment methods, content of recruitment material, and recommended incentives.
Conclusions


Online yoga may be beneficial for improving emotional regulation and self-compassion, but further testing is needed. Additionally, minority women express interest in online yoga but suggest that researchers apply culturally specific strategies regarding methods, content of material, and incentives to recruit minority women into a study.",2019,"After stillbirth, women are subject to a sevenfold increased risk of post-traumatic stress compared with women after a live-birth.","['five minority women who had experienced stillbirth', 'minority women after stillbirth', 'enroll minority women into phase two', 'Ten mothers ( N  = 5 stillbirth moms with no yoga experience,  N  = 5 nonstillbirth moms with yoga experience) participated in a series of', 'mothers after stillbirth']","['online yoga intervention', 'online yoga videos']","['SC and ER scores', 'risk of stillbirth', 'self-compassion (SC) and emotional regulation (ER', 'risk of post-traumatic stress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",10.0,0.0718188,"After stillbirth, women are subject to a sevenfold increased risk of post-traumatic stress compared with women after a live-birth.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': '1College of Health Solutions, Arizona State University, 500\u2009N. 3rd St., Phoenix, AZ 85004 USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': '1College of Health Solutions, Arizona State University, 500\u2009N. 3rd St., Phoenix, AZ 85004 USA.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Gold', 'Affiliation': '2Department of Family Medicine, Department of Obstetrics & Gynecology, University of Michigan, 1018 Fuller Street, Ann Arbor, MI 48104-1213 USA.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Leiferman', 'Affiliation': '3Colorado School of Public Health, University of Colorado Denver, 13001 E. 17th Place, B119 Bldg 500, Room E3341, Anschutz Medical Campus, Aurora, CO 80045 USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cacciatore', 'Affiliation': '4School of Social Work, Arizona State University, 411\u2009N. Central 8th Floor, Phoenix, AZ 85004 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-019-0526-2']
608,31237939,Risk of stroke and other adverse outcomes in patients with perioperative atrial fibrillation 1 year after non-cardiac surgery.,"AIMS


To determine the 1-year risk of stroke and other adverse outcomes in patients with a new diagnosis of perioperative atrial fibrillation (POAF) after non-cardiac surgery.
METHODS AND RESULTS


The PeriOperative ISchemic Evaluation (POISE)-1 trial evaluated the effects of metoprolol vs. placebo in 8351 patients, and POISE-2 compared the effect of aspirin vs. placebo, and clonidine vs. placebo in 10 010 patients. These trials included patients with, or at risk of, cardiovascular disease who were undergoing non-cardiac surgery. For the purpose of this study, we combined the POISE datasets, excluding 244 patients who were in atrial fibrillation (AF) at the time of randomization. Perioperative atrial fibrillation was defined as new AF that occurred within 30 days after surgery. Our primary outcome was the incidence of stroke at 1 year of follow-up; secondary outcomes were mortality and myocardial infarction (MI). We compared outcomes among patients with and without POAF using multivariable adjusted Cox proportional hazards models. Among 18 117 patients (mean age 69 years, 57.4% male), 404 had POAF (2.2%). The stroke incidence 1 year after surgery was 5.58 vs. 1.54 per 100 patient-years in patients with and without POAF, adjusted hazard ratio (aHR) 3.43, 95% confidence interval (CI) 2.00-5.90; P < 0.001. Patients with POAF also had an increased risk of death (incidence 31.37 vs. 9.34; aHR 2.51, 95% CI 2.01-3.14; P < 0.001) and MI (incidence 26.20 vs. 8.23; aHR 5.10, 95% CI 3.91-6.64; P < 0.001).
CONCLUSION


Patients with POAF have a significantly increased risk of stroke, MI, and death at 1 year. Intervention studies are needed to evaluate risk reduction strategies in this high-risk population.",2020,"Patients with POAF also had an increased risk of death (incidence 31.37 vs. 9.34; aHR 2.51, 95% CI 2.01-3.14; P < 0.001) and MI (incidence 26.20 vs. 8.23; aHR 5.10, 95% CI 3.91-6.64; P < 0.001).
","['patients with perioperative atrial fibrillation 1 year after non-cardiac surgery', 'Among 18\xa0117 patients (mean age 69\u2009years, 57.4% male), 404 had POAF (2.2', '244 patients who were in atrial fibrillation (AF) at the time of randomization', '8351 patients', 'patients with, or at risk of, cardiovascular disease who were undergoing non-cardiac surgery', 'patients with a new diagnosis of perioperative atrial fibrillation (POAF) after non-cardiac surgery', 'in 10\xa0010 patients']","['metoprolol vs. placebo', 'aspirin vs. placebo, and clonidine vs. placebo']","['1-year risk of stroke and other adverse outcomes', 'Perioperative atrial fibrillation', 'risk of stroke, MI, and death', 'risk of death', 'incidence of stroke at 1\u2009year of follow-up; secondary outcomes were mortality and myocardial infarction (MI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis (observable entity)'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",18117.0,0.449256,"Patients with POAF also had an increased risk of death (incidence 31.37 vs. 9.34; aHR 2.51, 95% CI 2.01-3.14; P < 0.001) and MI (incidence 26.20 vs. 8.23; aHR 5.10, 95% CI 3.91-6.64; P < 0.001).
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alonso-Coello', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main St W, Hamilton L8S 4K1, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douketis', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main St W, Hamilton L8S 4K1, Canada.'}, {'ForeName': 'Matthew T V', 'Initials': 'MTV', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong Special administrative Region, China.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44120, USA.'}, {'ForeName': 'Alben', 'Initials': 'A', 'LastName': 'Sigamani', 'Affiliation': 'Department of Clinical Research, Narayana Hrudayalaya Limited, 258/A, Hosur Road, Bommasandra Industrial Area, Anekal Taluk, Bangalore 560099, India.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Parlow', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre and Queen's University, 76 Stuart St, Kingston, ON K7L 2V7, Canada.""}, {'ForeName': 'Chew Yin', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': 'Departamento de Investigaciones, Fundación Cardioinfantil -Instituto de Cardiología and Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Av. 42 ##48 - 11, Bucaramanga, Santander, Colombia.'}, {'ForeName': 'Sadeesh K', 'Initials': 'SK', 'LastName': 'Srinathan', 'Affiliation': 'Department of Surgery, University of Manitoba, Rm. GE61, 820 Sherbrook Street, Winnipeg, MB R3A 1R9, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tiboni', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main St W, Hamilton L8S 4K1, Canada.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'School of Medicine, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, San Martín de Porres 15102, Lima, Peru.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main St W, Hamilton L8S 4K1, Canada.'}, {'ForeName': 'Soori', 'Initials': 'S', 'LastName': 'Sivakumaran', 'Affiliation': 'Department of Medicine, University of Alberta, 116 St & 85 Ave, Edmonton, AB T6G 2R3, Canada.'}, {'ForeName': 'Maria-Virginia', 'Initials': 'MV', 'LastName': 'Rodriguez Funes', 'Affiliation': 'Unidad de Investigacion Cientifica, Facultad de Medicina, Universidad de El Salvador, Final 25 Ave norte, San Salvador, El Salvador.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Cruz', 'Affiliation': 'Department of Anesthesia, Hospital General Universitario Gregorio Marañon, Calle del Dr. Esquerdo 46, 28007 Madrid, Spain.'}, {'ForeName': 'Homer', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, University of Western Ontario, 1151 Richmond St, London, ON N6A 3K7, Canada.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Dresser', 'Affiliation': 'Department of Medicine, London Health Sciences Centre, Victoria Hospital, 800 Commissioners Rd E, London, ON N6A 5W9, Canada.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Alvarez-Garcia', 'Affiliation': 'Department of Cardiology, Hospital de la Santa Creu i Sant Pau, CIBERCV, Biomedical Research Institute Sant Pau (IIB Sant Pau), Universitat Autonoma de Barcelona, Carrer de Sant Quintí, 89, 08041 Barcelona, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schricker', 'Affiliation': 'Department of Anesthesia, McGill University Health Centre, McGill University, 1001 Decarie Blvd, Montreal, QC H4A 3J1, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, University of Western Ontario, 1151 Richmond St, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Leanne W', 'Initials': 'LW', 'LastName': 'Drummond', 'Affiliation': 'Department of Anaesthesia, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, 719 Umbilo Road, Umbilo, 4001, South Africa.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Balasubramanian', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz431']
609,31230494,Magnesium Bioavailability and Tolerability Do Not Differ between Two Supplements with Different Release Properties.,"Magnesium (Mg 2+ ) is one of the most frequently supplemented micronutrients. Due to possible gastrointestinal side effects, the European Food Safety Authority and the Institute of Medicine set the upper intake level for Mg 2+  from supplements to 250 and 350 mg, respectively. Nevertheless, systematic data concerning the tolerability of Mg 2+  supplements are scarce. The aim of the study was to directly compare the bioavailability and tolerability of two 500 mg Mg 2+  supplements in a crossover study with duplicate determination. The different release properties were either a direct release (one phase) or a delayed release of the second half (two phases). An open-label, controlled trial with a crossover design, duplicate determination, and one-week washout phases was conducted. The participants ingested the test product after overnight fasting. Blood samples were taken at baseline and after 1, 2, 3, 4, 6, and 8 hours, and urine was collected over a period of 24 hours. The participants were on standardized nutrition during all examination days. There were no significant differences between the test products regarding 24-hour renal Mg 2+  excretion and area under the curve of serum Mg 2+  levels for 8 hours. Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products. The Mg 2+  bioavailability did not differ between the test products. The supplements examined had the same good tolerability. Both test products are therefore suited to enhance Mg 2+  supply without relevant side effects.",2020,Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products.,[],"['two 500\u2009mg Mg 2+  supplements', 'Magnesium (Mg 2+ ']","['bioavailability and tolerability', 'Magnesium Bioavailability and Tolerability', '24-hour renal Mg 2+  excretion and area under the curve of serum Mg 2+  levels']",[],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0300089,Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greupner', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Schneider', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gellert', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1629146']
610,30851032,Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction.,"AIMS


The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown.
METHODS AND RESULTS


We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25-0.66, P < 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P < 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES: -0.63 mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11 mm2, 95% CI: -2.27 to 0.04, P = 0.07).
CONCLUSION


Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov. Unique identifier: NCT00962416.",2019,"Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention.","['103 patients', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with acute ST-segment elevation myocardial infarction', '1157 patients (BES: N\u2009=\u2009575 and BMS: N\u2009=\u2009582', 'patients with STEMI undergoing primary percutaneous coronary intervention']","['bare-metal stent (BMS', 'intravascular ultrasound (IVUS) and optical coherence tomography', 'biodegradable polymer-based biolimus-eluting stents with bare-metal stents', 'biolimus-eluting stents (BESs) with biodegradable polymer']","['Definite stent thrombosis (ST', 'ischaemia-driven target lesion revascularization', 'vascular healing', '5-year rate of MACE', 'risk of major adverse cardiac events', 'rates of very late definite ST', 'frequency of malapposed stent struts', 'BES', 'positive remodelling']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",1157.0,0.305327,"Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention.","[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, Roskilde, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Queen Mary University of London, London, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': 'Division of Cardiology, University Hospital, Rue Gabrielle Perret-Gentil 4, Geneva, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, Enschede, the Netherlands.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Moschovitis', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Zaugg', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Miodrag', 'Initials': 'M', 'LastName': 'Ostojic', 'Affiliation': 'Cardiology Clinic, Clinical Center of Serbia, Visegradska 26, Belgrade, Serbia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pedrazzini', 'Affiliation': 'Department of Cardiology, Cardiocentro, Via Tesserete 46, Lugano, Switzerland.'}, {'ForeName': 'Dimitrios-Alexios', 'Initials': 'DA', 'LastName': 'Karagiannis-Voules', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Center for Molecular Cardiology, Schlieren Campus, University of Zurich, Wagistrasse 12, Schlieren, Switzerland.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petach Tikva, Tel Aviv University, Jabotinsky Street 39, Petah Tikwa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tüller', 'Affiliation': 'Cardiology Department, Triemlispital, Birmensdorferstrasse 497, Zurich, Switzerland.'}, {'ForeName': 'Vladan', 'Initials': 'V', 'LastName': 'Vukcevic', 'Affiliation': 'Cardiology Clinic, Clinical Center of Serbia, Visegradska 26, Belgrade, Serbia.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit, Institute of Social and Preventive Medicine, University of Bern, Mittelstrasse 43, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 8, Bern, Switzerland.'}]",European heart journal,['10.1093/eurheartj/ehz074']
611,31738072,Improvement in women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder.,"The cardiovascular system is disrupted by chronic excessive alcohol use and often impaired in individuals with an alcohol use disorder (AUD). Less is known about cardiovascular recovery when an individual receives treatment for AUD. This observational study aimed to extend the growing body of evidence for cardiovascular biomarkers and intervention targets in the treatment of AUD. We examined cardiovascular function in 92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD. Participants were recruited exclusively from a randomized clinical trial comparing group versus individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available. Demographic and drinking data were obtained from the parent study. Cardiovascular data were collected as part of this separate study, prior to and following the clinical trial. Mixed-model analyses revealed multiple within-person cardiovascular changes indicative of improving health from pre- to posttreatment, including reduced heart rate and vessel stiffness as well as increased heart rate variability and baroreflex sensitivity. These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions. Future studies should assess the time course of cardiovascular recovery during addiction treatment and the mechanisms by which evidence-based AUD treatments may benefit physical as well as mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","['individuals with an alcohol use disorder (AUD', ""women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder"", '92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD']","['individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available']","['heart rate variability and baroreflex sensitivity', 'heart rate and vessel stiffness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",2019.0,0.0455963,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000524']
612,31779715,Post-moderate-intensity exercise energy replacement does not reduce subsequent appetite and energy intake in adolescents with obesity.,"Exercise modifies energy intake (EI) in adolescents with obesity, but whether this is mediated by the exercise-induced energy deficit remains unknown. The present study examined the effect of exercise with and without dietary replacement of the exercise energy expenditure on appetite, EI and food reward in adolescents with obesity. Fourteen 12-15-year-old adolescents with obesity (eight girls; Tanner 3-4; BMI 34·8 (sd 5·7) kg/m2; BMI z score 2·3 (sd 0·4)) randomly completed three experimental conditions: (i) rest control (CON); (ii) 30-min cycling (EX) and (iii) 30-min cycling with dietary energy replacement (EX + R). Ad libitum EI was assessed at lunch and dinner, and food reward (Leeds Food Preference Questionnaire) before and after lunch. Appetite was assessed at regular intervals. Lunch, evening and total EI (excluding the post-exercise snack in EX - R) were similar across conditions. Lunch and total EI including the post-exercise snack in EX + R were higher in EX - R than CON and EX; EX and CON were similar. Total relative EI was lower in EX (6284 (sd 2042) kJ) compared with CON (7167 (sd 2218) kJ; P < 0·05) and higher in EX + R (7736 (sd 2033) kJ) compared with CON (P < 0·001). Appetite and satiety quotients did not differ across conditions (P ≥ 0·10). Pre-meal explicit liking for fat was lower in EX compared with CON and EX + R (P = 0·05). There was time by condition interaction between EX and CON for explicit wanting and liking for fat (P = 0·01). Despite similar appetite and EI, adolescents with obesity do not adapt their post-exercise food intake to account for immediate dietary replacement of the exercise-induced energy deficit, favouring a short-term positive energy balance.",2020,meal explicit liking for fat was lower in EX compared to CON and EX+R (p=0.05).,"['Fourteen 12-15 years adolescents with obesity (8girls; Tanner3-4', 'adolescents with obesity']","['Post- moderate intensity exercise energy replacement', 'rest control (CON); ii) 30-min cycling (EX); iii) 30-min cycling with dietary energy replacement (EX+R', 'exercise with and without dietary replacement of the exercise energy expenditure', 'Exercise modifies energy intake']","['Appetite and satiety quotients', 'Appetite', 'subsequent appetite and energy intake', 'meal explicit liking for fat', 'Ad libitum energy intake (EI', 'Lunch, evening and total EI', 'Total relative EI']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0396199,meal explicit liking for fat was lower in EX compared to CON and EX+R (p=0.05).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Roche', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont Auvergne University, EA 3533, Clermont-Ferrand, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, LeedsLS2 9JT, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, School of Psychology, University of Leeds, LeedsLS2 9JT, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), 63000, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Saitama169-0051, Japan.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, LeicestershireLE11 3TU, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, 63000, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Centre de Recherche en Nutrition Humaine (CRNH)-Auvergne, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Centre de Recherche en Nutrition Humaine (CRNH)-Auvergne, 63000 Clermont-Ferrand, France.'}]",The British journal of nutrition,['10.1017/S0007114519003106']
613,31189511,"Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.","BACKGROUND


Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A 1c  (HbA 1c ) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control.
METHODS


This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952.
FINDINGS


Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA 1c  7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001).
INTERPRETATION


Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors.
FUNDING


Eli Lilly and Company.",2019,"All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067).","['Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors', '46·3%] women', 'type 2 diabetes (REWIND', '371 sites in 24 countries', 'individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control', 'middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA 1c  7·2% [IQR 6·6-8·1], 4589', 'people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin']","['placebo', 'GLP-1 receptor agonist dulaglutide', 'subcutaneous injection of dulaglutide (1·5 mg) or placebo', 'glucagon-like peptide-1', 'GLP-1) receptor agonists', 'dulaglutide']","['All-cause mortality', 'cardiovascular outcomes', 'gastrointestinal adverse event', 'first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population', 'Dulaglutide and cardiovascular outcomes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}]",9901.0,0.806952,"All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067).","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'ECLA, Estudios Clínicos Latinoamérica, Rosario, Argentina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Riesmeyer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland.'}, {'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Hancu', 'Affiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.'}, {'ForeName': 'Markolf', 'Initials': 'M', 'LastName': 'Hanefeld', 'Affiliation': 'Department of Internal Medicine, Dresden Technical University, Dresden, Germany.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Holt', 'Affiliation': 'Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, FOSCAL and Medical School, Universidad de Santander UDES, Bucaramanga, Colombia.'}, {'ForeName': 'Ernesto German', 'Initials': 'EG', 'LastName': 'Cardona Munoz', 'Affiliation': 'Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Centre, Sofia, Bulgaria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31149-3']
614,31286497,The Roles of Group Status and Group Membership in the Practice of Hypodescent.,"Hypodescent emerged in U.S. history to reinforce racial hierarchy. Research suggests that among contemporary U.S. adults, hypodescent continues to shape social perception. Among U.S. children, however, hypodescent is less likely to be endorsed. Here, we tested for hypodescent by introducing U.S. children (ages 4-9) and adults (N = 273) to hierarchically ordered novel groups (one was high status and another was low status) and then to a child who had one parent from each group. In Study 1, we presented the groups in a third-party context. In Study 2, we randomly assigned participants to the high-status or the low-status group. Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.",2020,"Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.",['hypodescent by introducing U.S. children (ages 4-9) and adults (N\xa0=\xa0273) to hierarchically ordered novel groups (one was high status and another was low status) and then to a child who had one parent from each group'],[],[],"[{'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],[],,0.0263571,"Across both studies, participants did not reliably endorse hypodescent, raising questions as to what elicits this practice.","[{'ForeName': 'Steven O', 'Initials': 'SO', 'LastName': 'Roberts', 'Affiliation': 'Stanford University.'}, {'ForeName': 'Arnold K', 'Initials': 'AK', 'LastName': 'Ho', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Gülgöz', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Berka', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gelman', 'Affiliation': 'University of Michigan.'}]",Child development,['10.1111/cdev.13279']
615,30345498,Comparison of Classic and Inguinal Obturator Nerve Blocks Applied for Preventing Adductor Muscle Contractions in Bladder Tumor Surgeries: A Prospective Randomized Trial.,"PURPOSE


Obturator nerve block (ONB) has been performed in surgeries of transurethral resection of bladder tumors (TUR-BT) for the prevention of the development of obturator muscle contraction. Currently, classic and inguinal approaches are frequently being used. In the present study, we aimed to compare the success rate, performance speed, and complication risks of both approaches.
MATERIALS AND METHODS


Sixty-six patients who underwent TUR-BT under spinal anesthesia were randomly selected, and ONB was performed on the tumor location side using classic (n = 33) or inguinal (n = 33) approaches. Ten milliliters of 0.25% bupivacaine were administered using a peripheral nerve stimulator in both approaches.Two endpoints were defined in the study: Primary endpoint; the duration of the determination of the obturator nerve and number of interventions when each participant is assessed in at the end of the ONB procedure. Secondary endpoint; development of contractions, and complications each participant is assessed during the TUR-BT and 24 hours after ONB. (Clinical Trial Registration Number: ACTRN12617001050347)Result: General anesthesia was applied to the five patients in the classic ONB group who detected diffuse or bilateral tumors. These patients were excluded from the study. Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00). No complications were detected in both groups during the TUR-BT and 24 hours after ONB. We found that the inguinal approach provided a statistically significant advantage regarding the number of punctures (1.9 ± 0.9 versus1.5 ± 0.7) (P = .036), and duration of the procedure (99.1 ± 48.4 seconds versus 76.0 ± 31.9 seconds) (P=.029) compared with the classic approach.
CONCLUSION


Although complications and success rates were similar in both groups, the inguinal method may be abetter approach because it is faster and requires fewer punctures.",2019,"Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00).","['Bladder Tumor Surgeries', 'Sixty-six patients who underwent TUR-BT under spinal anesthesia were randomly selected, and ONB was performed on the tumor location side using classic (n = 33) or inguinal (n = 33) approaches', 'five patients in the classic ONB group who detected diffuse or bilateral tumors']","['Obturator nerve block (ONB', 'Classic and Inguinal Obturator Nerve Blocks', 'bupivacaine']","['Contractions', 'success rate, performance speed, and complication risks', 'duration of the determination of the obturator nerve and number of interventions', 'contractions, and complications each participant is assessed during the TUR-BT and 24 hours after ONB', 'complications and success rates']","[{'cui': 'C0005695', 'cui_str': 'Bladder Tumors'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0394741', 'cui_str': 'Local anesthetic obturator nerve block (procedure)'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0028783', 'cui_str': 'Obturator Nerve'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",66.0,0.0535178,"Contractions developed in 4 patients in each group, no statistically significant difference was detected between the groups (14.3%, n = 4 versus 12.1%, n = 4) (P = 1.00).","[{'ForeName': 'Recai', 'Initials': 'R', 'LastName': 'Dagli', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey. drresel@gmail.com.'}, {'ForeName': 'Mumtaz', 'Initials': 'M', 'LastName': 'Dadali', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Emir', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Bagbanci', 'Affiliation': 'Department of Urology, Ahi Evran University Faculty of Medicine, Kirsehir, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kirsehir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4176']
616,31254046,Adherence and effectiveness of a single instruction of pelvic floor exercises: a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS


In Brazil there are limited knowledge and education about preventative exercises for pelvic floor muscles (PFMs). We hypothesised that a single pelvic floor muscle exercise (PFME) session immediately postpartum would be effective in preventing urinary incontinence (UI) in a 3-month postpartum period with good adherence rates.
METHODS


Two hundred two women were approached for this randomised controlled trial and randomly assigned to two groups: the control group and experimental group. The intervention comprised a visual assessment of PFM contraction, a single PFME instruction session supervised by a physical therapist, and an educational approach through distribution of brochures about home-based PFME exercises (without supervision). Involuntary urinary loss and quality of life (QoL) were evaluated using the International Consultation on Incontinence Questionnaire Short Form (main outcome). Sociodemographic and clinical information was collected. Adherence and barriers were assessed via telephone/mobile phone surveys (secondary outcomes).
RESULTS


The adherence rate was 85.1%; only 37% of the women reported having some knowledge about PFME prior to participating in this study. The main barriers to PFME mentioned were forgetfulness (61.2%), lack of time (52.2%), and the need to take care of the baby (56.7%). One instruction session on postnatal PFME delivered in the immediate postpartum period was ineffective for improving urinary symptoms such as frequency of leakage (p = 0.821), amount of leakage (p = 0.746), and influence of leakage on QoL (p = 0.823). In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
CONCLUSIONS


Although the proposed intervention did not prevent UI symptoms, the adherence rate to PFME was high.",2020,"In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
",['Two hundred two women'],"['visual assessment of PFM contraction, a single PFME instruction session supervised by a physical therapist, and an educational approach through distribution of brochures about home-based PFME exercises (without supervision', 'single instruction of pelvic floor exercises', 'single pelvic floor muscle exercise (PFME) session immediately postpartum']","['Involuntary urinary loss and quality of life (QoL', 'Adherence and effectiveness', 'adherence rate', 'urinary symptoms such as frequency of leakage', 'adherence rate to PFME']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0429778', 'cui_str': 'Urinary loss (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0633055', 'cui_str': 'PFME'}]",202.0,0.0972799,"In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
","[{'ForeName': 'Cinara', 'Initials': 'C', 'LastName': 'Sacomori', 'Affiliation': ""School of Kinesiology, Universidad Bernardo O'Higgins, Santiago, Chile.""}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Zomkowski', 'Affiliation': 'Physical Therapy Department, Universidade do Sul de Santa Catarina-UNISUL, Palhoça, Santa Catarina, Brazil. kamillazomkowski@gmail.com.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Dos Passos Porto', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Fernando Luiz', 'Initials': 'FL', 'LastName': 'Cardoso', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Fabiana Flores', 'Initials': 'FF', 'LastName': 'Sperandio', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04032-6']
617,31800368,Overcoming Technological Challenges: Lessons Learned from a Telehealth Counseling Study.,"Background:   Telehealth methods, including video chat counseling, have been growing in popularity within the behavioral health counseling field for over a decade. While video-based counseling methods have been shown to be effective and convenient, they have unique challenges stemming from the technology they use. Technical challenges can negatively impact appointment flow, intervention effectiveness, and the satisfaction of both patients and clinicians.   Methodology:   The Y2TEC (Youth to Text or Telehealth for Engagement in HIV Care) study is a pilot randomized control trial examining the feasibility and acceptability of a video counseling series provided to young adults (ages 18-29) living with HIV. The study's clinicians provided about 500 video-based counseling sessions through the Zoom videoconferencing platform. The study team then developed recommendations for overcoming technical challenges through a review of the best practice literature, insights from the clinicians and study coordinator, engaging in consultations during supervision meetings, receiving verbal feedback from participants, and reviewing logs of technical challenges.   Results:   Through our experience, we have found that quality of video-based counseling services can be greatly improved with minor intentional technological modifications in preparation and provision of services. We provide an overview of common challenges and corresponding recommendations to address them.   Conclusion:   This article can help clinicians improve their quality of telehealth sessions by identifying several common technological challenges that can occur during video chat sessions, exploring the impact of these challenges on session dynamics and providing concise, best practice-based recommendations to mitigate these issues that clinicians face.",2020,The Y2TEC (Youth to Text or Telehealth for Engagement in HIV Care) study is a pilot randomized control trial examining the feasibility and acceptability of a video counseling series provided to young adults (ages 18-29) living with HIV.,['young adults (ages 18-29) living with HIV'],"['Y2TEC', 'video counseling series']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",[],500.0,0.0454998,The Y2TEC (Youth to Text or Telehealth for Engagement in HIV Care) study is a pilot randomized control trial examining the feasibility and acceptability of a video counseling series provided to young adults (ages 18-29) living with HIV.,"[{'ForeName': 'Angie R', 'Initials': 'AR', 'LastName': 'Wootton', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Caravella', 'Initials': 'C', 'LastName': 'McCuistian', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Legnitto Packard', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Saberi', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0191']
618,31244434,Co-ultraPEALut: Role in Preclinical and Clinical Delirium Manifestations.,"BACKGROUND


Delirium is a disorder in awareness, attention and cognition. Pathophysiologically it is a response to stress. Postoperative delirium (POD) is a usual complication in aged patients following hip fracture surgery. Neuroinflammation is an important factor linked with the progress of POD. Though there are no efficient cures for delirium the endocannabinoid system may have a role in neuropsychiatric disorders.
OBJECTIVE


Therefore, we examined the effects of co-ultramicronized PEALut (co-ultraPEALut) in the LPS murine model of delirium and in elderly hip fractured patients.
METHODS


In the preclinical study, mice were injected intraperitoneally (i.p.) with Escherichia coli LPS (10 mg/kg). Co-ultraPEALut (1 mg/kg o.s.) was administered 1h before LPS injection or 1h and 6h after LPS injection or 1h before LPS injection and 1h and 6h after LPS. In the clinical study, the effects of Glialia® (co-ultramicronized 700 mg PEA + 70 mg luteolin) administration was evaluated in elderly hip fractured patients with an interventional, randomized, single-blind, monocentric study.
RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins. In the clinical study, the results obtained demonstrated that administration of Glialia® to these surgical patients prevented the onset of POD and attenuated symptom intensity and their duration.
CONCLUSION


Therefore, the results obtained enhanced the idea that co-ultraPEALut may be a potential treatment to control cognitive impairment and the inflammatory and oxidative processes associated with delirium.",2019,"RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins.","['elderly hip fractured patients', 'aged patients following hip fracture surgery', 'elderly hip fractured patients with an interventional, randomized, single-blind, monocentric study']","['Glialia® (co-ultramicronized 700 mg PEA + 70 mg luteolin', 'Co-ultraPEALut', 'Glialia®', 'co-ultramicronized PEALut (co-ultraPEALut', 'Escherichia coli LPS']","['cognitive dysfunctions and locomotor activity', 'Postoperative delirium (POD', 'onset of POD and attenuated symptom intensity and their duration']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0065264', 'cui_str': 'Luteolin'}, {'cui': 'C4309121', 'cui_str': 'co-ultraPEALut'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0447037,"RESULTS


Administration of co-ultraPEALut to LPS-challenged mice ameliorated cognitive dysfunctions and locomotor activity; moreover, it reduced inflammation and apoptosis, while stimulating antioxidant response and limiting the loss of neurotrophins.","[{'ForeName': 'Maria Lia', 'Initials': 'ML', 'LastName': 'Lunardelli', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Crupi', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Siracusa', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cocuzza', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Cordaro', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Martini', 'Affiliation': ""Geriatric Unit - Orthogeriatric Ward, Universitary Sant'Orsola Policlinic Bologna, Bologna, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Di Paola', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cuzzocrea', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Science, University of Messina, Messina, Italy.'}]",CNS & neurological disorders drug targets,['10.2174/1871527318666190617162041']
619,31226213,Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.,"AIMS


The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel.
METHODS AND RESULTS


Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
CONCLUSION


Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.",2019,"Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
","['acute coronary syndrome patients treated with', '2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group', 'Acute coronary syndrome patients with PFT done 14\u2009days after hospital discharge were included with prior randomization to uniform', 'patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel']","['clopidogrel', 'prasugrel and clopidogrel', 'prasugrel for 12\u2009months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel']","['risk of ischaemic events', 'Platelet reactivity and clinical outcomes', 'ischaemic events', 'HPR', 'Low platelet reactivity', 'cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299575', 'cui_str': 'Treatment modification'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}]",2527.0,0.0460715,"Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups.
","[{'ForeName': 'Dániel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Department of Active Cardiology, Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University Budapest, 2 Gyógy Tér, Balatonfüred, Hungary.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gross', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Geisler', 'Affiliation': 'Department of Cardiology and Cardiovascular Disease, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Department of Cardiology, Heart and Vascular Centre, Semmelweis University Budapest, Budapest, Hungary.'}, {'ForeName': 'Róbert Gábor', 'Initials': 'RG', 'LastName': 'Kiss', 'Affiliation': 'Department of Cardiology, Military Hospital, Budapest, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Komócsi', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Csaba András', 'Initials': 'CA', 'LastName': 'Dézsi', 'Affiliation': 'Department of Cardiology, Petz Aladár County Hospital Győr, Győr, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruzsa', 'Affiliation': 'Department of Cardiology, Heart and Vascular Centre, Semmelweis University Budapest, Budapest, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Department of Cardiology, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Konstantinos D', 'Initials': 'KD', 'LastName': 'Rizas', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Andreas E', 'Initials': 'AE', 'LastName': 'May', 'Affiliation': 'Department of Cardiology, Innere Medizin I, Klinikum Memmingen, Memmingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mügge', 'Affiliation': 'Department of Cardiology, Katholisches Klinikum Bochum, St. Josef Hospital, Bochum, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Cardiology, Universitätsklinikum Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Lesca', 'Initials': 'L', 'LastName': 'Holdt', 'Affiliation': 'Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Medical Department, Cardiology and Intensive Care Medicine, Sigmund Freud Private University, Medical School, Wien, Austria.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Koltowski', 'Affiliation': '1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Huczek', 'Affiliation': '1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hadamitzky', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Department of Cardiology, LMU München, Munich, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz202']
620,32409982,"A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.","BACKGROUND


There is increasing interest in the use of purified cannabidiol (CBD) as a treatment for a wide range of conditions due to its reported anti-inflammatory, anxiolytic, antiemetic and anticonvulsant properties.
OBJECTIVE


The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single ascending dose of a new lipid-based oral formulation of CBD in healthy volunteers after a high-fat meal.
METHODS


A total of 24 eligible healthy volunteers (aged 18-48 years) were randomised to one of three sequential cohorts (each with six active  and two placebo subjects). Cohort 1 received 5 mg/kg CBD or placebo, cohort 2 received 10 mg/kg CBD or placebo (cohort 2), and cohort 3 received 20 mg/kg CBD or placebo. Data relating to adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications were collected to assess safety and tolerability. Blood samples were collected up to 8 days postdose and plasma was analysed by liquid chromatography and mass spectrometry to assess the pharmacokinetics of the CBD formulation.
RESULTS


CBD was well tolerated in the healthy volunteers (mean age: 24.0 years) treated with a single oral dose of CBD. There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar. The most frequently reported treatment emergent adverse events (TEAEs) were headache (17%) and diarrhoea (8%). There were no reported serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings that were reported as TEAEs or were of clinical significance during the study. After a high-fat meal, CBD was detected in plasma samples at 15 min postdose; the median time to maximum plasma concentration (T max ) was 4 h across all three CBD dose cohorts. The CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC)] increased in a dose-proportional manner and declined to levels approaching the lower level of quantification by day 8. The terminal elimination half-life was approximately 70 h, suggesting that 2-3 weeks are needed to fully eliminate CBD.
CONCLUSIONS


This new CBD formulation demonstrated a favourable safety and tolerability profile in healthy volunteers that was consistent with the profiles reported for other purified CBD products. No severe or serious AEs were observed in this study and there were no safety concerns.
TRIAL REGISTRATION


ACTRN12618001424291. Registered August 2018.",2020,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"['Fed Healthy Volunteers', 'healthy volunteers', 'healthy volunteers (mean age: 24.0\xa0years', '24 eligible healthy volunteers (aged 18-48\xa0years', 'healthy volunteers after a high-fat meal']","['new lipid-based oral formulation of CBD', 'Placebo', '10\xa0mg/kg CBD or placebo', '5\xa0mg/kg CBD or placebo', '20\xa0mg/kg CBD or placebo', 'purified cannabidiol (CBD', 'placebo']","['headache', 'Safety, Tolerability and Pharmacokinetics of Cannabidiol', 'safety profiles', 'adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications', 'tolerated', 'safety, tolerability and pharmacokinetics', 'median time to maximum plasma concentration (T max ', 'safety and tolerability', 'diarrhoea', 'severe or serious AEs', 'safety and tolerability profile', 'serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings', 'CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",24.0,0.234806,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia. daniel.perkins@dhhs.vic.gov.au.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ong', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Tri-Hung', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Neuroscience Trials Australia, Heidelberg, VIC, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Francis', 'Affiliation': 'Avance Clinical, Thebarton, SA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mcintosh', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lilley', 'Affiliation': ""Royal Children's Hospital, Parkville, VIC, Australia.""}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00624-6']
621,31216210,Videoconferencing psychotherapy for veterans with PTSD: Results from a randomized controlled non-inferiority trial.,"INTRODUCTION


Veterans with post-traumatic stress disorder (PTSD) face significant barriers that make it less likely for them to pursue treatment. A randomized controlled non-inferiority trial was used to determine if providing psychotherapy for PTSD via videoconference (VC) is as effective as in-person (IP) psychotherapy.
METHODS


All eligible veterans ( n  = 207) received cognitive processing therapy (CPT) to treat PTSD symptoms in one of the two treatment modalities. Participant symptoms were collected at baseline, post-treatment, and six months after treatment completion. The primary outcome measure, the Clinician-Administered PTSD Scale (CAPS), was used to assess PTSD diagnosis and symptom severity. Secondary outcomes included two self-report measures of symptom severity, the Post-traumatic Stress Disorder Checklist - Specific (PCL-S) for PTSD and the Patient Health Questionnaire - 9 (PHQ-9) for depressive symptoms. A linear mixed-effects model was used to assess non-inferiority for participants who completed treatment (completers) and those who were randomized to treatment (intention-to-treat (ITT)).
RESULTS


Both completer and ITT analyses showed that improvement in CAPS scores in the VC condition was non-inferior to that in the IP condition at six-month follow-up, but VC was inferior to IP for improvement in CAPS at post-treatment. Non-inferiority was supported by completer analyses for PCL-S and PHQ-9 in both post-treatment change and six-month follow-up change, and the ITT analysis supported the significant non-inferiority for PCL at post-treatment change.
DISCUSSION


These findings generally suggest that CPT delivered via VC can be as effective as IP for reducing the severity of PTSD symptoms.",2020,,['veterans with PTSD'],['Videoconferencing psychotherapy'],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],,0.134913,,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Thorp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Glassman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Busch', 'Affiliation': 'Veterans Medical Research Foundation, San Diego, CA, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Carie S', 'Initials': 'CS', 'LastName': 'Rodgers', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Allard', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Agha', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19853947']
622,31789965,Pulmonary levels of biomarkers for inflammation and lung injury in protective versus conventional one-lung ventilation for oesophagectomy: A randomised clinical trial.,"BACKGROUND


It is uncertain whether protective ventilation reduces ventilation-induced pulmonary inflammation and injury during one-lung ventilation.
OBJECTIVE


To compare intra-operative protective ventilation with conventional during oesophagectomy with respect to pulmonary levels of biomarkers for inflammation and lung injury.
DESIGN


Randomised clinical trial.
SETTING


Tertiary centre for oesophageal diseases.
PATIENTS


Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy.
INTERVENTIONS


Low tidal volume (VT) of 6 ml kg predicted body weight (pbw) during two-lung ventilation and 3 ml kgpbw during one-lung ventilation with 5 cmH2O positive end expired pressure versus intermediate VT of 10 ml kgpbw during two-lung ventilation and 5 ml kgpbw body weight during one-lung ventilation with no positive end-expiratory pressure.
OUTCOME MEASURES


The primary outcome was the change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation.
RESULTS


Median [IQR] VT in the protective ventilation group (n = 13) was 6.0 [5.7 to 7.8] and 3.1 [3.0 to 3.6] ml kgpbw during two and one-lung ventilation; VT in the conventional ventilation group (n = 16) was 9.8 [7.0 to 10.1] and 5.2 [5.0 to 5.5] ml kgpbw during two and one-lung ventilation. BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased. Changes in BAL biomarkers levels were not significantly different between the two ventilation strategies.
CONCLUSION


Intra-operative protective ventilation compared with conventional ventilation does not affect changes in pulmonary levels of biomarkers for inflammation and lung injury in patients undergoing one-lung ventilation for oesophagectomy.
TRIAL REGISTRATION


The 'Low versus Conventional tidal volumes during one-lung ventilation for minimally invasive oesophagectomy trial' (LoCo) was registered at the Netherlands Trial Register (study identifier NTR 4391).",2020,"BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased.","['patients undergoing one-lung ventilation for oesophagectomy', 'oesophagectomy', 'Tertiary centre for oesophageal diseases', 'Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy']","['ml\u200akg predicted body weight (pbw) during two-lung ventilation and 3\u200aml\u200akgpbw during one-lung ventilation with 5\u200acmH2O positive end expired pressure versus intermediate VT of 10\u200aml\u200akgpbw during two-lung ventilation and 5\u200aml\u200akgpbw body weight during one-lung ventilation with no positive end-expiratory pressure', 'conventional one-lung ventilation', 'protective ventilation', 'Intra-operative protective ventilation', 'conventional ventilation', 'Low tidal volume (VT) of 6']","['BAL levels of biomarkers for inflammation', 'change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation', 'BAL biomarkers levels', 'pulmonary levels of biomarkers for inflammation and lung injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014852', 'cui_str': 'Esophageal Diseases'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}]","[{'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0101725', 'cui_str': 'Advanced Glycosylation Endproduct Receptors'}, {'cui': 'C3536958', 'cui_str': 'Surfactant protein D'}, {'cui': 'C3840487', 'cui_str': 'CC16 - Clara cell protein 16'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}]",29.0,0.0619296,"BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased.","[{'ForeName': 'Margaretha C', 'Initials': 'MC', 'LastName': 'van der Woude', 'Affiliation': 'From the Department of Intensive Care Medicine (MCvdW, LB, RPvdH), Department of Anaesthesiology (MCvdW), Department of Pulmonology (RPvdH), Department of Surgery, Zuyderland Medical Centre, Heerlen (MNS, HJB), Department of Anaesthesiology (SNH), Laboratory of Experimental Intensive Care and Anaesthesiology (L·E·I·C·A), Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands (ATB, MJS), Department of Anaesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Dresden, Germany (MGdA), Department of Surgical Sciences and Integrated Diagnostics (PP), San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, University of Genoa, Genoa, Italy (PP), Department of Intensive Care, Amsterdam University Medical Centres, Location AMC, Amsterdam (PES, ASN, MJS), Department of Intensive Care Medicine, Gelre Hospitals, Apeldoorn, The Netherlands (PES), Department of Critical Care Medicine, Hospital Israelita Albert Einstein (ASN), Pulmonary Division, Cardio-Pulmonary Department, Instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil (ASN), Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand (MJS) and Nuffield Department of Medicine, University of Oxford, Oxford, UK (MJS).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bormans', 'Affiliation': ''}, {'ForeName': 'Robrecht P', 'Initials': 'RP', 'LastName': 'van der Horst', 'Affiliation': ''}, {'ForeName': 'Meindert N', 'Initials': 'MN', 'LastName': 'Sosef', 'Affiliation': ''}, {'ForeName': 'Henricus J', 'Initials': 'HJ', 'LastName': 'Belgers', 'Affiliation': ''}, {'ForeName': 'Sabrine N', 'Initials': 'SN', 'LastName': 'Hemmes', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Tuip-de Boer', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Spronk', 'Affiliation': ''}, {'ForeName': 'Ary Serpo', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': ''}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001126']
623,31295069,Dynamics of the power-duration relationship during prolonged endurance exercise and influence of carbohydrate ingestion.,"We tested the hypotheses that the parameters of the power-duration relationship, estimated as the end-test power (EP) and work done above EP (WEP) during a 3-min all-out exercise test (3MT), would be reduced progressively after 40 min, 80 min, and 2 h of heavy-intensity cycling and that carbohydrate (CHO) ingestion would attenuate the reduction in EP and WEP. Sixteen participants completed a 3MT without prior exercise (control), immediately after 40 min, 80 min, and 2 h of heavy-intensity exercise while consuming a placebo beverage, and also after 2 h of heavy-intensity exercise while consuming a CHO supplement (60 g/h CHO). There was no difference in EP measured without prior exercise (260 ± 37 W) compared with EP after 40 min (268 ± 39 W) or 80 min (260 ± 40 W) of heavy-intensity exercise; however, after 2 h EP was 9% lower compared with control (236 ± 47 W;  P  < 0.05). There was no difference in WEP measured without prior exercise (17.9 ± 3.3 kJ) compared with after 40 min of heavy-intensity exercise (16.1 ± 3.3 kJ), but WEP was lower ( P  < 0.05) than control after 80 min (14.7 ± 2.9 kJ) and 2 h (13.8 ± 2.7 kJ). Compared with placebo, CHO ingestion negated the reduction of EP following 2 h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ). These results reveal a different time course for the deterioration of EP and WEP during prolonged endurance exercise and indicate that EP is sensitive to CHO availability. NEW & NOTEWORTHY  The parameters of the power-duration relationship [critical power (CP) and the curvature constant (W')] have typically been considered to be static. Here we report the time course for reductions in CP and W', as estimated with the 3-min all-out cycle test, during 2 h of heavy-intensity exercise. We also show that carbohydrate ingestion during exercise preserves CP, but not W', without altering muscle glycogen depletion. These results provide new mechanistic and practical insight into the power-duration curve and its relationship to exercise-related fatigue development.",2019,"Compared to placebo, CHO ingestion negated the reduction of EP following 2-h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ).",['Sixteen participants completed a'],"['3MT without prior exercise (control), immediately after 40 min, 80 min and 2-h of heavy-intensity exercise while consuming a placebo beverage, and also after 2-h of heavy-intensity exercise while consuming a CHO supplement', 'carbohydrate ingestion', 'placebo, CHO ingestion']","['reduction of EP', 'EP', 'WEP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",16.0,0.0280821,"Compared to placebo, CHO ingestion negated the reduction of EP following 2-h of heavy-intensity exercise (254 ± 49 W) but had no effect on WEP (13.5 ± 3.4 kJ).","[{'ForeName': 'Ida E', 'Initials': 'IE', 'LastName': 'Clark', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Vanhatalo', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Joseph', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Black', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}, {'ForeName': 'Brad W', 'Initials': 'BW', 'LastName': 'Wilkins', 'Affiliation': 'Nike Sport Research Lab, Beaverton, Oregon.'}, {'ForeName': 'Brett S', 'Initials': 'BS', 'LastName': 'Kirby', 'Affiliation': 'Nike Sport Research Lab, Beaverton, Oregon.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Exeter, United Kingdom.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00207.2019']
624,1971275,Rectal indomethacin for postoperative pain in orthopaedic surgery. A double-blind study.,We report a double-blind study of the effectiveness of indomethacin suppositories in the relief of postoperative pain and the reduction in demand for opiate analgesia following orthopaedic procedures.,1990,We report a double-blind study of the effectiveness of indomethacin suppositories in the relief of postoperative pain and the reduction in demand for opiate analgesia following orthopaedic procedures.,"['orthopaedic procedures', 'orthopaedic surgery']","['Rectal indomethacin', 'indomethacin suppositories']",[],"[{'cui': 'C0524852', 'cui_str': 'Orthopedic Procedures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}]",[],,0.275832,We report a double-blind study of the effectiveness of indomethacin suppositories in the relief of postoperative pain and the reduction in demand for opiate analgesia following orthopaedic procedures.,"[{'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Twiston-Davies', 'Affiliation': 'Lord Mayor Treloar Hospital, Alton, Hampshire, England.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Goodwin', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Baxter', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
625,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
626,31791085,Percutaneous Ultrasound-Guided Core Needle Biopsy: Comparison of 16-Gauge versus 14-Gauge Needle and the Effect of Coaxial Guidance in 1065 Breast Biopsies - A Prospective Randomized Clinical Noninferiority Trial.,"PURPOSE


Ultrasound-guided core needle biopsy (CNB) is considered the standard assessment to diagnose sonographically visible suspicious breast mass lesions. Based on nonrandomized trials, the current German guidelines recommend at least three cylinders with ≤ 14-gauge needle biopsy. However, no recommendation is made as to how many specimens are needed with a smaller needle size, such as 16-gauge, or if biopsy with coaxial guidance improves diagnostic accuracy and quality. Therefore, in a prospective monocentric unblinded randomized controlled clinical noninferiority trial, the diagnostic accuracy of 16-gauge versus 14-gauge core needle biopsy, with and without coaxial guidance, was evaluated.
MATERIALS AND METHODS


1065 breast biopsies were included in order to analyze the number of core samples necessary to obtain an appropriate rate of diagnostic quality adequate for histological evaluation, and to achieve high diagnostic accuracy and diagnostic yield. Histological results were verified by surgery or long-term follow-up of at least two years up to five years.
RESULTS


In order to obtain an additive diagnostic accuracy of > 99 %, a minimum of two cylinders with 14-gauge biopsy were required. The diagnostic accuracy and the diagnostic quality of 14-gauge biopsy were not affected by the coaxial technique. When performing a 16-gauge biopsy, five cylinders were required to achieve an additive diagnostic accuracy of > 99 %. Without coaxial guidance, 16-gauge CNB required at least three samples, whereas five needle passes with coaxial-guided 16-gauge biopsy were needed.
CONCLUSION


The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.",2020,"The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.","['1065', '1065 Breast Biopsies ']","['Ultrasound-guided core needle biopsy (CNB', '16-gauge versus 14-gauge core needle biopsy, with and without coaxial guidance', 'Percutaneous Ultrasound-Guided Core Needle Biopsy', 'Coaxial Guidance', '16-Gauge versus 14-Gauge Needle', 'ultrasound-guided 16-gauge core needle biopsy']",['diagnostic accuracy and the diagnostic quality of 14-gauge biopsy'],"[{'cui': 'C0405352', 'cui_str': 'Biopsy of breast (procedure)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1318309', 'cui_str': 'Biopsy, Large-Core Needle'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",1065.0,0.0139932,"The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gruber', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Oberlechner', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': 'Frauenklinik, Klinikum Stuttgart Olgahospital Frauenklinik, Stuttgart, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Hoopmann', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Böer', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Fugunt', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gall', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Hartkopf', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Helms', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Sascha M', 'Initials': 'SM', 'LastName': 'Hoffmann', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Röhm', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Stäbler', 'Affiliation': 'Institute of Pathology and Neuropathology, University of Tübingen, Germany.'}, {'ForeName': 'Diethelm', 'Initials': 'D', 'LastName': 'Wallwiener', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': ""Department of Women's Health, University of Tübingen, Germany.""}]","Ultraschall in der Medizin (Stuttgart, Germany : 1980)",['10.1055/a-1014-2628']
627,31783132,Effects of Spicy Stimulation and Spicy-Food Consumption on Human Pain Sensitivity: A Healthy Volunteer Study.,"Spicy-food intake has been shown to affect various human physiological systems and diseases. This study tested the analgesia effect caused by stimulation of a spicy sensation (spicy stimulation) and explored the effect of spicy-food consumption on human basal pain sensitivity. A total of 60 healthy undergraduates were included in the primary study. Placebo and sweet stimulation were used as reference interventions. Pressure and cold-pain thresholds were measured before and after taste stimulation. The frequency of spicy-food intake was also evaluated. An additional 100 subjects were recruited to validate the results. Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P < .05). The increased thresholds remained, even when the taste stimulation residue was nearly eliminated (P < .05). The pressure (10.0 [2.1] vs 12.7 [3.0] kg/cm2, P < .001) and cold-pain (4.4 [1.6] vs 6.2 [2.7] seconds, P = .003) thresholds in subjects who consume spicy food ≥3 days/week were significantly lower than in those who consume it <3 days/week. In the validation population, the frequency of spicy-food intake was negatively associated with subjects' pressure (β = -.218, P = .013) and cold-pain (β = -.205, P = .035) thresholds. Spicy stimulation has an analgesia effect on adults that persists even after the taste stimulation stops. Conversely, a long-term spicy diet can reduce the human basal pain threshold. TRIAL REGISTRATION: The study protocol was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, People's Liberation Army (identification No., 2017-023-01), and it was registered on the Chinese Clinical Trial Registry at www.chictr.org.cn (No. ChiCTR1800015053). PERSPECTIVE: This study directly examined the effects of stimulation of a spicy sensation on adult pain sensitivity and was the first to explore the relationship between long-term spicy-food intake and human pain sensitivity. The results provide evidence for future clinical pain intervention and individualized pain treatment.",2020,"Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P<0.05).","['60 healthy undergraduates were included in the primary\xa0study', 'healthy volunteer study', 'An additional 100 subjects', ""Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, People's Liberation Army (identification No., 2017-023-01), and it was registered on the Chinese Clinical Trial Registry at www.chictr.org.cn (No""]","['Spicy stimulation', 'spicy stimulation and spicy-food consumption', 'spicy sensation (spicy stimulation', 'Placebo and sweet stimulation', 'Spicy-food intake', 'spicy sensation', 'spicy-food consumption']","['frequency of spicy-food intake', 'pressure and cold-pain thresholds', 'Pressure and cold-pain thresholds', 'cold-pain', 'adult pain sensitivity', 'human basal pain sensitivity', 'human pain sensitivity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0453864', 'cui_str': 'Spicy food (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0559575', 'cui_str': 'Spicy food intake (observable entity)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0559575', 'cui_str': 'Spicy food intake (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",60.0,0.093995,"Compared to placebo stimulation, both pressure and cold-pain thresholds increased during spicy stimulation (P<0.05).","[{'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Zhuoxi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Zhenxin', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Guiying', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Xiaohang', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, China. Electronic address: lh78553@163.com.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.011']
628,31911074,"Assessing the effects of 6 weeks of intermittent aerobic exercise on aerobic capacity, muscle fatigability, and quality of life in diabetic burned patients: Randomized control study.","BACKGROUND


Both burn and diabetes mellitus (DM) cause functional and psychosocial disabilities. A low-cost and safe approach is greatly required to reduce these disabilities and the effects of aerobic exercise have generated varied evidence to date. The aim of the study was to explore the effects of 6 weeks of intermittent aerobic exercise (IAE) on aerobic capacity, muscle fatigability, and quality of life (QoL) in diabetic burned patients (DBPs).
METHODS


The study design was a prospective, single-blind, randomized controlled trial. Between March 2018 and July 2019 thirty-six (22 males and 16 females) diabetic burned patients were included in the study, their age ranged 35-55 years. They were clinically diagnosed with type 2 DM and total body surface area (TBSA) was 15-30%. The participants were randomly assigned to the IAE group (n = 18) and controls (n = 18). Aerobic capacity, muscle fatigability, and QoL were assessed initially and repeated after 6 weeks of intervention.
RESULTS


Initial data demonstrated non-significant differences between the IAE and control groups (p > 0.05). Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05). The IAE group showed statistically significant improvement more than the control group in all outcome measures (p < 0.05).
CONCLUSIONS


6 weeks of intermittent aerobic exercise is an effective alternative modality to improve aerobic capacity, muscle fatigability, and QoL in DBPs. Adherence to intermittent aerobic exercise should be practicable into mainstream clinical intervention for those patients.",2020,"Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05).","['diabetic burned patients (DBPs', 'diabetic burned patients', 'Between March 2018 and July 2019 thirty-six (22 males and 16 females) diabetic burned patients were included in the study, their age ranged 35-55 years']","['IAE', 'intermittent aerobic exercise', 'intermittent aerobic exercise (IAE']","['VO 2 max, muscle fatigability, QoL domains', 'aerobic capacity, muscle fatigability, and QoL in DBPs', 'aerobic capacity, muscle fatigability, and quality of life', 'total body surface area (TBSA', 'Aerobic capacity, muscle fatigability, and QoL', 'aerobic capacity, muscle fatigability, and quality of life (QoL']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0058453', 'cui_str': 'discoidin-binding polysaccharide'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0231230', 'cui_str': 'Fatigability (finding)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0058453', 'cui_str': 'discoidin-binding polysaccharide'}, {'cui': 'C0034380'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0474954,"Comparing pre- and post-intervention outcomes showed significant improvement of VO 2 max, muscle fatigability, QoL domains in the IAE group after 6 weeks intervention (p < 0.05) and non-significant changes in the control group (p > 0.05).","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt. Electronic address: walidkamal.wr@gmail.com.'}, {'ForeName': 'Nermeen Mohamed', 'Initials': 'NM', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Egypt.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.12.013']
629,31197264,Health-related quality of life in blood pressure control and blood lipid-lowering therapies: results from the CHIEF randomized controlled trial.,"Our study aimed to explore changes in health-related quality of life (HRQoL) during blood pressure control and blood lipid-lowering therapies. We conducted a 2 × 2 factorial-designed randomized controlled trial in 180 clinical centers in China. At baseline, participants were randomly assigned to an amlodipine + amiloride/hydrochlorothiazide group or an amlodipine + telmisartan group for the blood pressure control treatment and to a statin group or a routine intervention group for the blood lipid-lowering treatment. The allocation ratio was 1:1 for both treatments. Follow-up lasted for 4 years. HRQoL was assessed using the EuroQol five dimensions three levels (EQ-5D-3L) questionnaire every year. Of 13,542 hypertensive patients enrolled in the clinical trial, 9885 were eligible for the analysis. The problems for all dimensions of the EQ-5D-3L descriptive system were slight at baseline and were well preserved in the follow-up period. The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not. Decreases in systolic/diastolic blood pressure and low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were independently correlated with increases in the EQ VAS score and the EQ-5D-3L index. In conclusion, HRQoL is associated with blood pressure/lipid levels but not with specific antihypertensive or lipid-lowering interventions. Blood pressure control and blood lipid-lowering therapies should not be denied to Chinese patients in consideration of their negative effects on quality of life.",2019,"The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not.","['13,542 hypertensive patients enrolled in the clinical trial, 9885 were eligible for the analysis', '180 clinical centers in China']","['amlodipine\u2009+\u2009telmisartan', 'statin group or a routine intervention group for the blood lipid-lowering treatment', 'amlodipine\u2009+\u2009amiloride/hydrochlorothiazide']","['blood pressure/lipid levels', 'systolic/diastolic blood pressure and low-density lipoprotein cholesterol', 'EQ VAS score and the EQ-5D-3L index', 'EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index', 'health-related quality of life (HRQoL', 'high-density lipoprotein cholesterol', 'HRQoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0717400', 'cui_str': 'Amiloride / Hydrochlorothiazide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",13542.0,0.165109,"The EuroQol visual analog scale (EQ VAS) score and the EQ-5D-3L index improved over time (P trend  < 0.001), with improvements similar among interventions but different between patients who reached the treatment targets or not.","[{'ForeName': 'Ruohua', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong-Qiu', 'Initials': 'HQ', 'LastName': 'Gu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. liwei@mrbc-nccd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0281-z']
630,31740072,"Long-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).","BACKGROUND


The long-term oncological outcomes of laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC) are still maturing compared with open radical cystectomy (ORC).
OBJECTIVE


To evaluate the 5-yr oncological outcomes of patients recruited into the randomised trial of Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion.
DESIGN, SETTING, AND PARTICIPANTS


A review of prospectively maintained database of 60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC) who were previously randomised in the CORAL trial to receive ORC, RARC, or LRC. This trial was designed to compare the perioperative and early oncological outcomes of these techniques.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes of interest included 5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Kaplan-Meier curves were used to plot the recurrence and survival data. The curves between RFS, CSS, and OS were compared using the log-rank test. A two-sided p value <0.05 was considered significant. Results were analysed on the basis of intention to treat.
RESULTS AND LIMITATIONS


A total of 60 patients with either MIBC (n=38) or HRNMIBC (n=21) were randomised in the CORAL trial to receive ORC, RARC, or LRC. The 5-yr RFS was 60%, 58%, and 71%; 5-yr CSS was 64%, 68%, and 69%; and 5-yr OS was 55%, 65%, and 61% for ORC, RARC, and LRC, respectively. There was no significant difference in RFS, CSS, and OS between the three surgical arms. The principal limitation is the small sample size.
CONCLUSIONS


There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer. Minimally invasive techniques achieved equivalent oncological outcomes to the gold standard of ORC. However, the study was based at a single institution with a small sample size.
PATIENT SUMMARY


Patients who agreed to participate in the randomised trial of either open, laparoscopic, or robotic-assisted radical cystectomy for bladder cancer did not have different cancer outcomes at 5yr.",2020,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","['60 patients with either MIBC (n=38) or HRNMIBC (n=21', '60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC']","['Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion', 'ORC, RARC, or LRC', 'Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL', 'open, laparoscopic, or robotic-assisted radical cystectomy', 'open radical cystectomy (ORC', 'laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC']","['5-yr CSS', 'curves between RFS, CSS, and OS', 'RFS, CSS, and OS', 'equivalent oncological outcomes', '5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS', '5-yr RFS, CSS, and OS rates', '5-yr OS', '5-yr RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.280624,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","[{'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK. Electronic address: shamim.khan@gstt.nhs.uk.""}, {'ForeName': 'Kawa', 'Initials': 'K', 'LastName': 'Omar', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK; Department of Urology, King's College Hospital, Denmark Hill, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""King's College London, School of Cancer and Pharmaceutical Studies, Translational Oncology & Urology Research (TOUR), London, UK.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Thurairaja', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rimington', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK.""}]",European urology,['10.1016/j.eururo.2019.10.027']
631,31178009,Efficacy of a Home-Based Parent Training-Focused Weight Management Intervention for Preschool Children: The DRIVE Randomized Controlled Pilot Trial.,"OBJECTIVES


To pilot-test a home-based parent training intervention aimed at maintaining body weight among children at risk for obesity (> the 75th body mass index percentile).
METHODS


Sixteen parent-child dyads were randomized to a health education or Developing Relationships that Include Values of Eating and Exercise (DRIVE) intervention arm. The DRIVE curriculum was a structured parenting program to promote healthy weight in children by relying on behavioral principles to promote skill acquisition in the family's natural setting. Body weight and waist circumference were measured at baseline and weeks 9 and 19.
RESULTS


Body mass index z-score, body weight, and percent body weight increased in children in the health education arm vs DRIVE at weeks 9 and 19. Body weight, percent body weight, and waist circumference decreased in parents in DRIVE vs the health education arm at week 19, whereas no differences were shown at week 9.
CONCLUSIONS AND IMPLICATIONS


The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents. Home-based interventions emphasizing parent-child interactions are indicated as a practical model to deliver weight management in children.",2019,The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents.,"['children', 'children at risk for obesity (> the 75th body mass index percentile', 'Sixteen parent-child dyads', 'Preschool Children']","['Home-Based Parent Training-Focused Weight Management Intervention', 'home-based parent training intervention', 'health education or Developing Relationships that Include Values of Eating and Exercise (DRIVE) intervention arm']","['Body mass index z-score, body weight, and percent body weight', 'weight gain', 'Body weight and waist circumference', 'Body weight, percent body weight, and waist circumference']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.0378361,The DRIVE program mitigated weight gain in a small sample of at-risk children and showed promising results in reducing weight in parents.,"[{'ForeName': 'Keely R', 'Initials': 'KR', 'LastName': 'Hawkins', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA.'}, {'ForeName': 'Jenelle R', 'Initials': 'JR', 'LastName': 'Shanley', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, GA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA. Electronic address: Corby.martin@pbrc.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.002']
632,31106659,Randomized Study of the Effect of Vitamin D and Omega-3 Fatty Acids Cosupplementation as Adjuvant Chemotherapy on Inflammation and Nutritional Status in Colorectal Cancer Patients.,"This study aimed to evaluate the effects of vitamin D 3  and omega-3 fatty acids cosupplementation on inflammation and nutritional status in colorectal cancer patients. In this clinical trial, 81 colorectal cancer patients were randomly assigned into four groups: (1) control group: receiving a vitamin D 3  placebo weekly + omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids) daily + a vitamin D 3  placebo weekly; (3) vitamin D group: receiving a 50,000 IU vitamin D 3  soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000 IU vitamin D 3  soft gel weekly + 2 omega-3 fatty acids capsules daily for 8 weeks. Before and after the intervention, height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin, were measured. After 8 weeks of intervention, patients who received combined vitamin D 3  and omega-3 fatty acids supplements compared with omega-3, vitamin D 3 , and placebo groups had significantly decreased CRP and TNF-α. In addition, serum level of IL-6 was decreased significantly in omega-3, vitamin D 3 , and cosupplementation groups compared with baseline. Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention. Vitamin D 3  plus omega-3 fatty acids cosupplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.",2020,"Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention.","['Colorectal Cancer Patients', 'colorectal cancer patients', '81 colorectal cancer patients']","['Vitamin D 3  plus omega-3 fatty acids cosupplementation', 'vitamin D 3  and omega-3 fatty acids cosupplementation', 'Vitamin D and Omega-3 Fatty Acids Cosupplementation', 'control group: receiving a vitamin D 3  placebo weekly\u2009+\u2009omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330\u2009mg of omega-3 fatty acids) daily\u2009+\u2009a vitamin D 3  placebo weekly; (3) vitamin D group: receiving a 50,000\u2009IU vitamin D 3  soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000\u2009IU vitamin D 3  soft gel weekly + 2 omega-3 fatty acids capsules daily for 8\u2009weeks', 'combined vitamin D 3  and omega-3 fatty acids supplements compared with omega-3, vitamin D 3 , and placebo']","['CRP and TNF-α', 'serum level of IL-6', 'nutritional status, weight, BMI, and FFM', 'Inflammation and Nutritional Status', 'inflammation and nutritional status', 'height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]",81.0,0.0704157,"Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1600096']
633,31098977,Effects of Intensive Primary Care on High-Need Patient Experiences: Survey Findings from a Veterans Affairs Randomized Quality Improvement Trial.,"BACKGROUND


Intensive primary care programs aim to coordinate care for patients with medical, behavioral, and social complexity, but little is known about their impact on patient experience when implemented in a medical home.
OBJECTIVE


Determine how augmenting the VA's medical home (Patient Aligned Care Team, PACT) with a PACT-Intensive Management (PIM) program influences patient experiences with care coordination, access, provider relationships, and satisfaction.
DESIGN


Cross-sectional analysis of patient survey data from a five-site randomized quality improvement study.
PARTICIPANTS


Two thousand five hundred sixty-six Veterans with hospitalization risk scores ≥ 90th percentile and recent acute care.
INTERVENTION


PIM offered patients intensive care coordination, including home visits, accompaniment to specialists, acute care follow-up, and case management from a team staffed by primary care providers, social workers, psychologists, nurses, and/or other support staff.
MAIN MEASURES


Patient-reported experiences with care coordination (e.g., health goal assessment, test and appointment follow-up, Patient Assessment of Chronic Illness Care (PACIC)), access to healthcare services, provider relationships, and satisfaction.
KEY RESULTS


Seven hundred fifty-nine PIM and 768 PACT patients responded to the survey (response rate 60%). Patients randomized to PIM were more likely than those in PACT to report that they were asked about their health goals (AOR = 1.26; P = 0.046) and that they have a VA provider whom they trust (AOR = 1.35; P = 0.005). PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048). However, other effects on coordination, access, and satisfaction did not achieve statistical significance.
CONCLUSIONS


Augmenting VA's patient-centered medical home with intensive primary care had a modestly positive influence on high-risk patients' experiences with care coordination and provider relationships, but did not have a significant impact on most patient-reported access and satisfaction measures.",2019,"PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048).","['Seven hundred fifty-nine PIM and 768 PACT patients', 'Two thousand five hundred sixty-six Veterans with hospitalization risk scores ≥\u200990th percentile and recent acute care']","['Intensive Primary Care', 'PIM offered patients intensive care coordination, including home visits, accompaniment to specialists, acute care follow-up, and case management from a team staffed by primary care providers, social workers, psychologists, nurses, and/or other support staff', 'PACT-Intensive Management (PIM) program']","['mean (SD) PACIC scores', 'experiences with care coordination (e.g., health goal assessment, test and appointment follow-up, Patient Assessment of Chronic Illness Care (PACIC)), access to healthcare services, provider relationships, and satisfaction', 'coordination, access, and satisfaction']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",2566.0,0.0560513,"PIM patients also had higher mean (SD) PACIC scores compared with PACT patients (2.91 (1.31) vs. 2.75 (1.25), respectively; P = 0.022) and were more likely to report 10 out of 10 on satisfaction with primary care (AOR = 1.25; P = 0.048).","[{'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Zulman', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA. dzulman@stanford.edu.'}, {'ForeName': 'Evelyn T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Yoon', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Stockdale', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA, USA.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Rubenstein', 'Affiliation': 'Department of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Asch', 'Affiliation': 'Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Menlo Park, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04965-0']
634,31153095,Selective invalidation of ambivalent pro-marijuana attitude components.,"INTRODUCTION


Attitudes of drug-abstinent youth considering marijuana initiation can be highly ambivalent. Invalidating pro-usage elements (i.e., opinions) of ambivalent marijuana attitudes, while leaving anti-marijuana elements intact, may create stronger, less ambivalent marijuana-resistant attitudes and lower usage intentions, while concurrently elucidating the role of ambivalence in persuasive prevention.
METHOD


From an initial pool of marijuana-abstinent middle-school students (N = 538), the quintile expressing the most negative attitudes toward a marijuana prevention appeal (N = 101) were randomly assigned to one of three conditions designed to invalidate pro-marijuana opinions. Analyses then tested their susceptibility to a second marijuana prevention appeal.
RESULTS


Personally threatening messages were found ineffective, but appeals contesting resistant responses significantly decreased ambivalence (p < .01). Mediational analyses showed that this decreased ambivalence was associated with less favorable attitudes and lower marijuana usage intentions (both p < .001). An attribution-based manipulation increased ambivalence (p < .05), which was associated with positive usage intentions mediated through positive attitudes (both p < .001).
CONCLUSION


Analyses elucidated the role of attitude ambivalence in prevention, providing a more complete understanding of potential facilitative use of ambivalence in prevention models based on prevention. Results support the further examination and use of methods that invalidate pro-marijuana opinions, thereby leading to greater susceptibility to subsequent prevention appeals.",2019,"Personally threatening messages were found ineffective, but appeals contesting resistant responses significantly decreased ambivalence (p < .01).","['marijuana-abstinent middle-school students (N\u202f=\u202f538), the quintile expressing the most negative attitudes toward a marijuana prevention appeal (N\u202f=\u202f101']",[],['favorable attitudes and lower marijuana usage intentions'],"[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",101.0,0.0124177,"Personally threatening messages were found ineffective, but appeals contesting resistant responses significantly decreased ambivalence (p < .01).","[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, Claremont, CA 91711, United States of America. Electronic address: william.crano@cgu.edu.'}, {'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, Claremont, CA 91711, United States of America.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, Claremont, CA 91711, United States of America.'}, {'ForeName': 'Eusebio M', 'Initials': 'EM', 'LastName': 'Alvaro', 'Affiliation': 'Department of Psychology, Claremont Graduate University, Claremont, CA 91711, United States of America.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychology, Claremont Graduate University, Claremont, CA 91711, United States of America.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.05.020']
635,31053213,Effects of Two-Week Sleep Extension on Glucose Metabolism in Chronically Sleep-Deprived Individuals.,"STUDY OBJECTIVES


Sleep deprivation is known to be associated with insulin resistance and diabetes risk. This study investigated whether 2-week sleep extension in chronically sleep-deprived individuals would improve glucose metabolism.
METHODS


A crossover study was conducted in volunteers without diabetes who reported sleeping ≤ 6 h/night. They were randomized to maintain their habitual sleep or extend sleep time for 2 weeks, then crossed over after a washout period. Sleep was monitored by actigraphy. Oral glucose tolerance tests (75 g) with insulin levels was performed at the end of each period. Mixed-effect linear regression analysis, adjusting for sequence and period effects, was applied.
RESULTS


A total of 21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol. Mean sleep duration during habitual sleep was 318.7 (44.3) minutes and the participants extended their sleep by 36.0 (45.2) minutes during sleep extension. The average washout period was 21 (11) days. There were no significant effects of sleep extension on any metabolic parameters. The per-protocol analysis included eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes). Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference -0.50 [95% confidence interval [CI] -0.89, -0.11,  P  = .013]), early insulin secretion (insulinogenic index; mean difference 0.39 [95% CI 0.15, 0.63,  P  = .001]), and β-cell function (disposition index, mean difference 1.07 [95% CI 0.17, 1.97,  P  = .02]).
CONCLUSIONS


Sleep extension in chronically sleep-deprived individuals improved glucose metabolism in only those who could objectively extend their sleep to more than 6 h/night. Our findings suggest that a critical amount of sleep is needed to benefit metabolic outcomes.",2019,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","['volunteers without diabetes who reported sleeping ≤ 6 h/night', 'Chronically Sleep-Deprived Individuals', 'eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes', '21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol', 'chronically sleep-deprived individuals']",['Two-Week Sleep Extension'],"['early insulin secretion (insulinogenic index', 'Sleep', 'Glucose Metabolism', 'Oral glucose tolerance tests', 'glucose metabolism', 'β-cell function (disposition index', 'Homeostatic Model Assessment of Insulin Resistance', 'Mean sleep duration during habitual sleep']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]",8.0,0.0585718,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","[{'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'So-Ngern', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Chanprasertyothin', 'Affiliation': 'Research Center, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirimon', 'Initials': 'S', 'LastName': 'Reutrakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7758']
636,31761933,A Parsimonious Host Inflammatory Biomarker Signature Predicts Incident TB and Mortality in Advanced HIV.,"BACKGROUND


People with advanced HIV (CD4<50) remain at high risk of TB or death despite the initiation of antiretroviral therapy. We aimed to identify immunological profiles that were most predictive of incident TB disease and death.
METHODS


The REMEMBER randomized clinical trial enrolled 850 participants with HIV (CD4<50 cells/µL) at ART initiation to receive either empiric TB treatment or isoniazid preventive therapy (IPT). A case-cohort study (n=257) stratified by country and treatment arm was performed. Cases were defined as incident TB or all-cause death within 48 weeks after ART initiation. Using multiplexed immunoassay panels and ELISA, 26 biomarkers were assessed in plasma.
RESULTS


52 (6.1%) of 850 participants developed TB; 47 (5.5%) died (13 of whom had antecedent TB). Biomarkers associated with incident TB overlapped with those associated with death (IL-1β, IL-6). Biomarker levels declined over time in individuals with incident TB while remaining persistently elevated in those who died. Dividing the cohort into development and validation sets, the final model of 6 biomarkers (CXCL10, IL-1β, IL-10, sCD14, TNF-α, and TNF-β) achieved a sensitivity of 0.90 (95% CI: 0.87-0.94) and a specificity of 0.71(95% CI: 0.68-0.75) with an area under the curve (AUC) of 0.81 (95% CI: 0.78-0.83) for incident TB.
CONCLUSION


Among people with advanced HIV, a parsimonious inflammatory biomarker signature predicted those at highest risk for developing TB despite initiation of ART and TB preventive therapies. The signature may be a promising stratification tool to select patients who may benefit from increased monitoring and novel interventions.",2019,"RESULTS


52 (6.1%) of 850 participants developed TB;","['People with advanced HIV (CD4<50', '850 participants with HIV (CD4<50 cells/µL) at ART initiation to receive either', 'people with advanced HIV']",['empiric TB treatment or isoniazid preventive therapy (IPT'],"['Biomarker levels', 'TB']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",850.0,0.563055,"RESULTS


52 (6.1%) of 850 participants developed TB;","[{'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD USA.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Andrade', 'Affiliation': 'Instituto Gonçalo Moniz, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, Bahia, Brazil.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Leong', 'Affiliation': 'Department of Medicine, Center for Emerging Pathogens, Rutgers, New 24 Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Kintali', 'Affiliation': 'Department of Medicine, Center for Emerging Pathogens, Rutgers, New 24 Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Matoga', 'Affiliation': 'UNC Project Malawi, Lilongwe Malawi.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Riviere', 'Affiliation': 'Les Centres GHESKIO Clinical Research Site, Port au prince, Haiti.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Sameneka', 'Affiliation': 'University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jerrold J', 'Initials': 'JJ', 'LastName': 'Ellner', 'Affiliation': 'Department of Medicine, Center for Emerging Pathogens, Rutgers, New 24 Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe Malawi.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Bisson', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Padmini', 'Initials': 'P', 'LastName': 'Salgame', 'Affiliation': 'Department of Medicine, Center for Emerging Pathogens, Rutgers, New 24 Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1147']
637,32410198,The Role of Skin Thickness in the Choice of a Rhinoplasty Technique for Thin-Skinned Patients: Analysis of Long-Term Results and Patient Satisfaction.,"INTRODUCTION


This randomized controlled study aimed to analyse the long-term results of thin-skinned patients who underwent rhinoplasty.
MATERIALS AND METHODS


All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2 years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study. The patients were randomly divided into 4 groups as follows: group 1, camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum. Patients answered the Italian version of the FACE-Q rhinoplasty module. The Obagi skin pinch test was used to measure nasal skin thickness. We compared pre- and post-operative patient satisfaction with the appearance of their nose between the 4 patient groups by the Chi-squared test for unpaired data. Two plastic surgeons reviewed all the post-operative photographs of the study patients and rated the photographs on a scale of 1 to 5.
RESULTS


A total of 101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study. The mean patient age was 38.5 years. The mean follow-up time was 2.5 years. The differences between the preoperative and post-operative FACE-Q values for group 1 were significant (P < 0.01), whereas the differences between the preoperative and post-operative FACE-Q values for the other groups were not significant. The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01). Groups 2 and 4 underwent more secondary procedures than groups 1 and 3 (P < 0.01). The 2 reviewers determined that patient groups 1 and 3 obtained more satisfactory outcomes than groups 1 and 4 (P < 0.01).
CONCLUSIONS


This was the first randomized study to demonstrate that diced cartilage grafts used for thin-skinned patients was the best approach for obtaining a satisfactory long-term outcome and durable natural appearance.
LEVEL OF EVIDENCE I


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"['All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2\xa0years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study', '101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study', 'thin-skinned patients who underwent rhinoplasty', 'mean patient age was 38.5\xa0years']","['diced cartilage grafts', 'camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum']","['preoperative and post-operative FACE-Q values', 'satisfactory outcomes', 'Skin Thickness', 'nasal skin thickness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0225213', 'cui_str': 'Temporal fascia structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",101.0,0.030166,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Panasiti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppola', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Russo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01763-6']
638,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
639,31134608,Modified Mini-laparoscopic Surgery Optimized the Laparoscopic Decortication of Renal Cyst.,"PURPOSE


This study was to introduce the modified mini-laparoscopic surgery for renal cyst and investigate itsadvantages on operative time, cosmetic effect and pain reduction by comparison with laparo-endoscopic single sitesurgery (LESS) and conventional laparoscopic surgery.
METHODS AND PATIENTS


Between May 2015 and October 2018, 140 consecutive patients with benign renal cystunderwent laparoscopic decortication of renal cyst. Of which, 48 cases were in mini-laparoscopic surgery group(M group), 56 cases in LESS group and 36 cases in conventional laparoscopic surgery group (C group). The operativetime, blood loss, visual analog scale (VAS) and Scar Cosmesis Assessment and Rating (SCAR) Scale wasrecorded.
RESULTS


The mean operative time in M group (26.08±7.70 min) and C group (28.56 ± 7.99 min). was significantlyless than that in LESS group (47.32 ±10.53 min) (P < 0.01). Mean blood loss did not differ between the 3 groups(P > 0.05). Mean VAS pain scores in M group were significantly lower than that of LESS group and C group onpostoperative day (POD) 1 and 3 (P < 0.01). The SCAR scale of POD 30 in C group (6.25 ± 1.0) was significantlyhigher than that in M group (0.77 ± 0.59) and LESS group (0.98 ± 0.70). The postoperative course was uneventfulwith no morbidity within 1to 6 months of follow-up.
CONCLUSION


Modified mini-laparoscopic decortication of renal cyst have more comprehensive advantages comparingwith LESS and conventional laparoscopic surgery. It is convenient and offered significant cosmetic benefitand reduced incisional pain.",2019,Mean blood loss did not differ between the 3 groups (P>0.05).,['140 consecutive patients with benign renal cyst underwent laparoscopic decortication of renal cyst'],"['modified mini-laparoscopic surgery', 'LESS', 'LESS and conventional laparoscopic surgery', 'conventional laparoscopic surgery', 'laparo-endoscopic single site surgery (LESS) and conventional laparoscopic surgery', 'Modified mini-laparoscopic decortication of renal cyst', 'Modified Mini-laparoscopic Surgery']","['Mean VAS pain scores', 'incisional pain', 'mean operative time', 'Mean blood loss', 'SCAR scale of POD', 'operative time, cosmetic effect and pain reduction', 'operative time, blood loss, visual analog scale (VAS) and Scar Cosmesis Assessment and Rating (SCAR']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0268800', 'cui_str': 'Simple renal cyst (disorder)'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2678502', 'cui_str': 'Decortication (procedure)'}, {'cui': 'C0268800', 'cui_str': 'Simple renal cyst (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",140.0,0.0358773,Mean blood loss did not differ between the 3 groups (P>0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University. chen.wei3@zs-hospital.sh.cn.'}, {'ForeName': 'Zhi-Bing', 'Initials': 'ZB', 'LastName': 'Xu', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Cang', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Guo', 'Affiliation': 'Urology Department of Zhongshan Hospital, Fudan University.'}]",Urology journal,['10.22037/uj.v0i0.5029']
640,31098961,Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial.,"PURPOSE


Neuropathic pain, resulting from injury to the peripheral or central nervous system, is due to upregulation of aberrant sodium channels with neuronal hyperexcitability. Lidocaine blocks these channels and several studies show that intravenous (IV) lidocaine infusion provides significant relief in patients with chronic peripheral neuropathic pain in the short term (for up to six hours). Our objective was to determine if IV lidocaine provides significant pain relief and overall improvement in quality of life in the longer term (for up to four weeks).
METHODS


This single site randomized double-blind, crossover trial compared IV lidocaine infusion (5 mg·kg -1 ) with active placebo infusion containing diphenhydramine (50 mg) in patients with chronic neuropathic pain of peripheral nerve origin of at least six months duration. The primary outcome was average pain intensity reduction from IV lidocaine relative to placebo at four weeks post-infusion. Secondary outcome measures included parameters of physical function, mood, and overall quality of life.
RESULTS


We enrolled 34 subjects in this trial-mostly with painful diabetic neuropathy and post-herpetic neuralgia. There were no significant differences between IV lidocaine and placebo infusions at any time point involving any of the outcome measures. Mean (standard deviation) pain intensity at week 4 for the placebo and lidocaine groups were not different [6.58 (1.97) vs 6.78 (1.56), respectively; between-group difference, 0.17; 95% confidence interval, - 0.50 to 0.84].
CONCLUSION


We found no significant long-term analgesic or quality of life benefit from IV lidocaine relative to control infusion for chronic peripheral neuropathic pain.
TRIAL REGISTRATION


clinicaltrials.gov (NCT01669967); registered 22 June, 2012.",2019,"We found no significant long-term analgesic or quality of life benefit from IV lidocaine relative to control infusion for chronic peripheral neuropathic pain.
","['chronic peripheral neuropathic pain', 'patients with', '34 subjects in this trial-mostly with painful diabetic neuropathy and post-herpetic neuralgia', 'patients with chronic neuropathic pain of peripheral nerve origin of at least six months duration']","['Lidocaine', 'placebo', 'lidocaine', 'Intravenous lidocaine', 'lidocaine infusion (5 mg·kg -1 ) with active placebo infusion containing diphenhydramine']","['chronic peripheral neuropathic pain', 'average pain intensity reduction', 'quality of life', 'parameters of physical function, mood, and overall quality of life', 'Mean (standard deviation) pain intensity', 'pain relief']","[{'cui': 'C4546313', 'cui_str': 'Chronic peripheral neuropathic pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C4546313', 'cui_str': 'Chronic peripheral neuropathic pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",34.0,0.722091,"We found no significant long-term analgesic or quality of life benefit from IV lidocaine relative to control infusion for chronic peripheral neuropathic pain.
","[{'ForeName': 'Dwight E', 'Initials': 'DE', 'LastName': 'Moulin', 'Affiliation': 'Department of Clinical Neurological Sciences and Oncology, Western University, London, ON, Canada. dwight.moulin@lhsc.on.ca.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Morley-Forster', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Zameer', 'Initials': 'Z', 'LastName': 'Pirani', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Western University, London, ON, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Rohfritsch', 'Affiliation': 'Lawson Health Research Institute, London, ON, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Stitt', 'Affiliation': 'Statistical Services, London, ON, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01395-8']
641,31149935,Trajectories of Pain Intensity Over 1 Year in Adults With Disabling Subacute or Chronic Neck Pain.,"OBJECTIVES


The objectives of this study were to describe the 1-year trajectories of disabling subacute or persistent neck pain and to investigate whether baseline age, sex, pain characteristics, and depressive symptoms are associated with such trajectories.
STUDY DESIGN AND SETTING


Participants (n=617) included in a randomized controlled trial provided weekly pain intensity ratings by responding to text messages over 1 year. We used latent class mixed model analyses to identify clusters of individual trajectories. Thereafter, we used logistic regression to determine the association between baseline age, sex, pain characteristics, depressive symptoms and treatment, and trajectories of neck pain.
RESULTS


Six different clusters of trajectories were identified. Most participants (73%) followed a trajectory of decreasing pain throughout follow-up. The remaining experienced unfavorable trajectories: persistent pain of high intensity (22%) and slightly (3%) or highly (2%) fluctuating levels of pain reaching high levels of pain intensity. Pain intensity at baseline: odds ratio (OR): 3.76 (95% confidence interval [CI]: 2.49-5.68), depressive symptoms: OR: 3.46 (95% CI: 2.01-5.95), younger age: OR: 2.29 (95% CI: 1.48-3.54), female sex: OR: 1.51 (95% CI: 1.01-2.26), and sudden onset of pain: OR: 1.74 (95% CI: 1.13-2.69) were associated with unfavorable trajectories.
CONCLUSIONS


Most individuals with disabling subacute or chronic neck pain show improvement in pain intensity over a year. However, a quarter present unfavorable trajectories. High pain intensity at baseline, depressive symptoms, younger age, female sex, and sudden onset of pain are factors associated with unfavorable trajectories.",2019,"Pain intensity at baseline: odds ratio (OR): 3.76 (95% confidence interval [CI]: 2.49-5.68), depressive symptoms: OR: 3.46 (95% CI: 2.01-5.95), younger age: OR: 2.29 (95% CI: 1.48-3.54), female sex: OR: 1.51 (95% CI: 1.01-2.26), and sudden onset of pain: OR: 1.74 (95% CI: 1.13-2.69) were associated with unfavorable trajectories.
","['Most individuals with disabling subacute or chronic neck pain', 'Adults With Disabling Subacute or Chronic Neck Pain', 'Participants (n=617']",[],"['High pain intensity', 'sudden onset of pain', 'Pain intensity', 'depressive symptoms', 'Pain Intensity', 'pain of high intensity', 'pain intensity', 'pain reaching high levels of pain intensity', '1-year trajectories of disabling subacute or persistent neck pain', 'pain intensity ratings']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1272517', 'cui_str': 'Sudden onset'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]",,0.261031,"Pain intensity at baseline: odds ratio (OR): 3.76 (95% confidence interval [CI]: 2.49-5.68), depressive symptoms: OR: 3.46 (95% CI: 2.01-5.95), younger age: OR: 2.29 (95% CI: 1.48-3.54), female sex: OR: 1.51 (95% CI: 1.01-2.26), and sudden onset of pain: OR: 1.74 (95% CI: 1.13-2.69) were associated with unfavorable trajectories.
","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Pico-Espinosa', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Côté', 'Affiliation': 'Faculty of Health Sciences and UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology, Toronto, ON, Canada.'}, {'ForeName': 'Sheilah', 'Initials': 'S', 'LastName': 'Hogg-Johnson', 'Affiliation': 'Faculty of Health Sciences and UOIT-CMCC Centre for the Study of Disability Prevention and Rehabilitation, University of Ontario Institute of Technology, Toronto, ON, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute.'}, {'ForeName': 'Iben', 'Initials': 'I', 'LastName': 'Axén', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute for Environmental Medicine, Karolinska Institute.'}, {'ForeName': 'Lena W', 'Initials': 'LW', 'LastName': 'Holm', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skillgate', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000727']
642,31864178,Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials.,"BACKGROUND


Previous analyses of BREAK-2 and BREAK-3 showed that durable outcomes lasting ≥3 years are achievable with dabrafenib in some patients with BRAF V600-mutant metastatic melanoma (MM); however, additional follow-up is needed to fully characterise the long-term impact of dabrafenib in these patients.
METHODS


BREAK-2 was a single-arm phase 2 study evaluating dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM. BREAK-3, a randomised (3:1) phase 3 study, assessed dabrafenib versus dacarbazine in previously untreated unresectable or metastatic BRAF V600E-mutant melanoma. Five-year analyses were performed.
RESULTS


All BREAK-2 patients (N = 92 [V600E, n = 76; V600K, n = 16]) discontinued treatment by the data cutoff. Median follow-up was 13.0 months. In BRAF V600E patients, 5-year progression-free survival (PFS) and overall survival (OS) were 11% and 20%, respectively. Subsequent immunotherapy was received by 22% of patients. In BREAK-3, median follow-up was 17.0 and 12.0 months in the dabrafenib (n = 187) and dacarbazine (n = 63) arms, respectively. Thirty-seven patients (59%) receiving dacarbazine crossed over to dabrafenib following disease progression as per protocol. Five-year PFS was 12% in the dabrafenib arm; all dacarbazine-arm patients progressed or were censored by 5 years. Dabrafenib improved PFS versus dacarbazine, regardless of baseline lactate dehydrogenase levels. Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively. Subsequent therapy in each arm included anti-CTLA-4 (dabrafenib [24%] and dacarbazine [24%]) and/or anti-PD-1 (8% and 2%) treatment. No new safety signals were observed.
CONCLUSIONS AND RELEVANCE


These data, representing extended follow-up for dabrafenib monotherapy, demonstrate that durable benefit lasting ≥5 years is achievable in a subset of patients.
TRIAL REGISTRATION


ClinicalTrials.gov (BREAK-2, NCT01153763; BREAK-3, NCT01227889).",2020,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","['previously untreated unresectable or metastatic BRAF V600E-mutant melanoma', 'patients with BRAF V600-mutant metastatic melanoma (MM', 'patients with BRAF V600-mutant metastatic melanoma receiving']","['dabrafenib versus dacarbazine', 'dabrafenib monotherapy', 'dacarbazine', 'dabrafenib in treatment-naive or previously treated BRAF V600E/K-mutant MM', 'dabrafenib']","['baseline lactate dehydrogenase levels', '5-year progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",37.0,0.387792,"Five-year OS rates were 24% and 22% in the dabrafenib and dacarbazine arms, respectively.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. Electronic address: ahauschild@dermatology.uni-kiel.de.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione ""G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Lev V', 'Initials': 'LV', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Dermatology and CIC Department, Hôpital Saint-Louis, INSERM U976, University Paris Diderot, Paris, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'University of Western Australia, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kefford', 'Affiliation': 'Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Haas', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': ""D'Amelio"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Bijoyesh', 'Initials': 'B', 'LastName': 'Mookerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Chapman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.033']
643,31146613,"The Novel Effects of a Hydrolyzed Polysaccharide Dietary Supplement on Immune, Hepatic, and Renal Function in Adults with HIV in a Randomized, Double-Blind, Placebo-Control Trial.","The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A 6-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + individuals on stable antiretroviral therapy were enrolled and randomly assigned to one of the 2 study conditions ( n  = 22 RBAC and  n  = 25 placebo) and consumed 3 gram/day of either compound for 6 months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers remained nearly completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD = 0.62) at baseline to 1.07 (SD = 0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD = 0.80) at baseline to 0.72 (SD = 0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.",2020,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04).","['Adults with HIV', 'HIV\u2009+\u2009individuals', 'Forty-seven HIV\u2009+\u2009individuals on stable antiretroviral therapy']","['RBAC and  n \u2009=\u200925 placebo', 'placebo', 'hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC', 'Placebo', 'Hydrolyzed Polysaccharide Dietary Supplement']","['Immune, Hepatic, and Renal Function', 'CD8+ count', 'percentage change in CD8+ count', 'liver and kidney markers', 'CD4+ and CD8+, liver enzymes, and kidney function', 'CD4+/CD8+ ratio', 'immune, hepatic, and renal function', 'percentage change in CD4']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.387552,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Atlas Bsn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Muhammad H', 'Initials': 'MH', 'LastName': 'Abbas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Rasul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ashar', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lantigua', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'Glow Health, PA, Bay Harbor Islands, FL, USA.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Lages', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Higuera', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiallo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judi M', 'Initials': 'JM', 'LastName': 'Woolger', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ciraula', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Konefal', 'Affiliation': 'Department of Family Medicine and Community Health, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1619010']
644,31124381,Effect of Cholecalciferol Supplementation on Treatment Response and IL-10 Level in Vitamin D Deficient  Parthenium  Dermatitis Patients: A Randomized Double-Blind Placebo-Controlled Trial.,"Allergic contact dermatitis following exposure to  Parthenium  is a chronic disease associated with frequent relapses and significant disturbance in the quality of life. The affected patients have lower circulating levels and decreased expression of IL-10. Hence, measures to increase its level may enhance the therapeutic outcome. The clinical trial was undertaken to evaluate the effect of cholecalciferol supplementation on treatment response and IL-10 level in  Parthenium  dermatitis patients with vitamin D deficiency. A total of 72 patients were recruited and randomized to receive either cholecalciferol tablet 60,000 IU per week or matching placebo for 8 weeks with standard background treatment. Eczema Area Severity Index (EASI) and Dermatology Life Quality Index (DLQI) were assessed at baseline, 4 weeks, and 8 weeks while IL-10 and serum 25-hydroxyvitamin D levels were measured at baseline and 8 weeks. Levels of 25-hydroxyvitamin D and IL-10 showed a significant rise in both placebo and vitamin D groups following the intervention. The relatively higher increase in IL-10 level observed in the vitamin D group was statistically insignificant compared to placebo group. Significant reduction in EASI, as well as DLQI scores, was noted after 1 and 2 months, but the reduction in these scales was not significantly different between the groups. Cholecalciferol supplementation for 2 months did not reduce the disease severity in clinically diagnosed  Parthenium  dermatitis patients. However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.",2020,"However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.","['A total of 72 patients', 'Vitamin D Deficient  Parthenium  Dermatitis Patients', 'Parthenium  dermatitis patients with vitamin D deficiency', 'clinically diagnosed  Parthenium  dermatitis patients']","['Cholecalciferol supplementation', 'placebo', 'Placebo', 'cholecalciferol supplementation', 'cholecalciferol tablet 60,000\u2009IU per week or matching placebo', 'cholecalciferol', 'Cholecalciferol Supplementation']","['Treatment Response and IL-10 Level', 'IL-10 and serum 25-hydroxyvitamin D levels', 'IL-10 level', 'DLQI scores', 'Eczema Area Severity Index (EASI) and Dermatology Life Quality Index (DLQI', 'disease severity', 'plasma IL-10 levels', 'Levels of 25-hydroxyvitamin D and IL-10', 'treatment response and IL-10 level', 'EASI', 'expression of IL-10']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",72.0,0.588655,"However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.","[{'ForeName': 'Alphienes', 'Initials': 'A', 'LastName': 'Stanley Xavier', 'Affiliation': 'Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, India.'}, {'ForeName': 'Sandhiya', 'Initials': 'S', 'LastName': 'Selvarajan', 'Affiliation': 'Department of Clinical Pharmacology, JIPMER, Puducherry, India.'}, {'ForeName': 'Laxmisha', 'Initials': 'L', 'LastName': 'Chandrasekar', 'Affiliation': 'Department of Dermatology, JIPMER, Puducherry, India.'}, {'ForeName': 'Sadishkumar', 'Initials': 'S', 'LastName': 'Kamalanathan', 'Affiliation': 'Department of Endocrinology, JIPMER, Puducherry, India.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1619009']
645,31748836,Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX).,"PURPOSE


Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis.
METHODS


We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU.
RESULTS


Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8-70] vs. 47 h [IQR 11-93], absolute difference, 23 h; 95% CI 8-38), and more time receiving an FiO 2  of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1-79] vs. 0 h [IQR 0-10], absolute difference, 20 h; 95% CI 14-26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy.
CONCLUSIONS


Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group.
CLINICAL TRIALS REGISTRY


ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.",2020,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","['patients with sepsis', 'Patients with sepsis allocated to', 'ICU patients', 'mechanically ventilated adults with sepsis', '251 patients with sepsis enrolled in a trial that compared', '1000 mechanically ventilated ICU patients']","['oxygen therapy (ICU-ROX', 'conservative oxygen therapy', 'usual oxygen therapy', 'Conservative oxygen therapy', 'conservative oxygen therapy with usual oxygen therapy']","['cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",1000.0,0.413117,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care and Trauma, The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-019-05857-x']
646,32410200,Effect of Photobiomodulation on Ecchymosis after Rhinoplasty: A Randomized Single-Blind Controlled Trial.,"BACKGROUND


This study was conducted to compare the effect of photobiomodulation therapy (low-level laser therapy) on ecchymosis after rhinoplasty.
SUBJECTS AND METHODS


Sixty rhinoplasty candidates were randomly divided into two groups. Photobiomodulation, including red light (660 nm), infrared light (840 nm), and infrared laser, was used in the first group on the first postoperative day, and its effect on periorbital ecchymosis was evaluated.
RESULTS


The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
CONCLUSION


Photobiomodulation may be effectively used for reducing ecchymosis after rhinoplasty.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . RCT registration number is IRCT20080820001056N3.",2020,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
",['Sixty rhinoplasty candidates'],"['Photobiomodulation, including red light (660\xa0nm), infrared light (840\xa0nm), and infrared laser', 'photobiomodulation therapy (low-level laser therapy', 'Photobiomodulation']","['Ecchymosis', 'periorbital ecchymosis', 'ecchymosis']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C2053461', 'cui_str': 'Periorbital ecchymosis'}]",,0.0712924,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
","[{'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Amali', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Saedi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran. saedi@tums.ac.ir.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01760-9']
647,31730401,Can Reliability of the Chinese Medicine Diagnostic Process Be Improved? Results of a Prospective Randomized Controlled Trial.,"Background:  The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration.  Objectives:  (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability.  Design:  Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training.  Analysis:  The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings.  Results:  Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant ( p  = 0.227 and  p  = 0.126, respectively).  Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.",2019,Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument.,['women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM'],"['Traditional Chinese Medicine (TCM', 'TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training']",['reliability of TCM diagnosis of dysmenorrhea'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025129', 'cui_str': 'Traditional Medicine, East Asia'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]",38.0,0.0421075,Conclusions:  A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument.,"[{'ForeName': 'Rosa N', 'Initials': 'RN', 'LastName': 'Schnyer', 'Affiliation': 'Adult Health, University of Texas School of Nursing, Austin, TX.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McKnight', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, VA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Conboy', 'Affiliation': 'New England School of Acupuncture, MCPH University, Worcester, MA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobson', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Ledegza', 'Affiliation': 'Alkermes, Inc., Waltham, MA.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Quilty', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.""}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0260']
648,30496423,Optimizing decision-making among childcare staff on fever and common infections: cluster randomized controlled trial.,"BACKGROUND


Children 0-4 years attending childcare are more prone to acquire infections than home-cared children. Childcare illness absenteeism due to fever is mostly driven by fear towards fever in childcare staff and parents. This may cause high childcare absenteeism, healthcare service use, and work absenteeism in parents. This study evaluates a multicomponent intervention targeting determinants of decision-making among childcare staff on illness absenteeism due to fever and common infections.
METHODS


The multicomponent intervention was developed based on the Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video. The intervention was evaluated in a cluster randomized controlled trial in Southern Netherlands. Nine centres received the intervention and nine provided childcare-as-usual. Primary outcome measure was the percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days in a 12-week period. Secondary outcome measures included intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff. Outcomes were analyzed using linear mixed models accounting for clustering. Knowledge was descriptively analysed.
RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%). Secondary outcomes showed significant improvements in intervention group regarding intended behaviour, two of three attitude dimensions. Knowledge increased compared with control but no differences regarding self-efficacy.
CONCLUSION


The intervention was not effective in reducing illness absenteeism. However, the intervention improved determinants of decision-making such as intended behaviour, attitude, and knowledge on fever.
TRIAL REGISTRATION


NTR6402 (registered on 21 April 2017).",2019,"RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%).","['Children 0-4 years attending childcare', 'childcare staff on illness absenteeism due to fever and common infections', 'childcare staff on fever and common infections', 'Southern Netherlands']","['intervention and nine provided childcare-as-usual', 'multicomponent intervention', 'Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video']","['illness absenteeism', 'percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days', 'intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff', 'Overall illness absenteeism', 'decision-making such as intended behaviour, attitude, and knowledge on fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.161949,"RESULTS


Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%).","[{'ForeName': 'K K B', 'Initials': 'KKB', 'LastName': 'Peetoom', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J M H A', 'Initials': 'JMHA', 'LastName': 'Bohnen', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Dinant', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J W L', 'Initials': 'JWL', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.'}]",European journal of public health,['10.1093/eurpub/cky246']
649,31138501,Morphometric Assessment of Resected Femoral Cut Surface in Korean Knees and Its Fitting With Western-Designed Femoral Components.,"BACKGROUND


This study aimed at assessing the morphometry of resected femurs in Korean patients during total knee arthroplasty (TKA) and comparing these measurements with current Western-designed femoral component dimensions.
METHODS


This single-blind, prospective, randomized, controlled trial involved intraoperative measurements for 271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options. The difference between femoral component dimensions and the resected surface of distal femur was measured in millimeters at 5 distinct zones.
RESULTS


Overhang of standard femoral component was common in the anterior-medial condyle and anterior-lateral condyle ranging from 50.8% to 99.0% and 21.5% to 88.0%, respectively. With narrow femoral components, the rate of overhang reduced to 21.5%-30.2% and 9.2%-32.1%. Conversely, underhang rates were higher over the anterior flange width, middle medial-lateral and posterior medial-lateral zones. Standard components displayed higher underhang rates at these zones compared to narrow components. The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%. System with narrow option sizing increases the underhang rates in males, while improving the component fit among females at similar zones with rate ranging from 5.2% to 52.9%.
CONCLUSION


Currently available TKA implant designs may not provide a perfect match for the distal femoral shape of the Korean population. The availability of implants with standard and narrow options can substantially improve the optimal fitting of femoral components in the Korean population.",2019,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"['271 femoral component implantations from 3 contemporary TKA systems, with 2 systems offering narrow sizing options', 'Korean patients during total knee arthroplasty (TKA']",[],"['femoral component dimensions and the resected surface of distal femur', 'femoral component', 'rate of overhang', 'underhang rates']","[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",[],"[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]",271.0,0.0755389,The good fit rate for femoral component was low among the 3 systems ranging from 1.0% to 56.0%.,"[{'ForeName': 'Teck S', 'Initials': 'TS', 'LastName': 'Fong', 'Affiliation': 'Department of Orthopaedic Surgery, Putrajaya Hospital, Federal Government Administrative Centre, Putrajaya, Malaysia; Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Seong Chan', 'Initials': 'SC', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ji Eui', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Eui Soo', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Tae Woo', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong Seuk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.061']
650,31746480,Late implant placement following ridge preservation versus early implant placement: A pilot randomized clinical trial for periodontally compromised non-molar extraction sites.,"AIM


To compare late implant placement following alveolar ridge preservation (LP/ARP) and early implantation (EP) in periodontally compromised non-molar extraction sites with respect to soft tissue levels, aesthetics, and patient-reported outcomes.
MATERIALS AND METHODS


Sixteen patients were randomly allocated to groups LP/ARP (n = 9) or EP (n = 7). Group LP/ARP received ARP using deproteinized bovine bone mineral containing 10% collagen and a native bilayer collagen membrane, and group EP received only extraction. Implant placement was performed 4-8 weeks post-extraction in group EP and 4 months post-alveolar ridge preservation in group LP/ARP. The soft tissue levels, pink/white esthetic scores, and periodontal parameters were evaluated at 1 year post-loading. Patient's discomfort level was evaluated in terms of extraction/ARP and implant placement.
RESULTS


No implant failure or biologic complications occurred. There was no statistically significant difference in the median change of the midfacial mucosal margin (0.03 for group LP/ARP, -0.19 mm for group EP) and the mesial/distal papilla (0.62/0.25 mm for group LP/ARP, 0.29/-0.5 mm for group EP), pink/white esthetic scores, periodontal parameters, and patient's discomfort between the two groups.
CONCLUSION


Both implant placement protocols led to comparable outcomes in soft tissue levels, periodontal parameters, and patient's discomfort level.",2020,There was no statistically significant difference in the median change of the midfacial mucosal margin (0.03 for group LP/,"['periodontally compromised non-molar extraction sites', 'Sixteen patients']","['alveolar ridge preservation (LP/ARP) and early implantation (EP', 'Late implant placement following ridge preservation versus early implant placement', 'EP', 'LP/ARP']","['implant failure or biologic complications', 'mesial/distal papilla', ""soft tissue levels, periodontal parameters, and patient's discomfort level"", 'soft tissue levels, pink/white esthetic scores, and periodontal parameters', ""pink/white esthetic scores, periodontal parameters, and patient's discomfort"", ""Patient's discomfort level"", 'median change of the midfacial mucosal margin']","[{'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}]","[{'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0549183', 'cui_str': 'Midline (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",16.0,0.0537115,There was no statistically significant difference in the median change of the midfacial mucosal margin (0.03 for group LP/,"[{'ForeName': 'Hyun-Chang', 'Initials': 'HC', 'LastName': 'Lim', 'Affiliation': 'Department of Periodontology, Periodontal-Implant Clinical Research Institute, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seongwoo', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Periodontology, Periodontal-Implant Clinical Research Institute, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jung-Chul', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Department of Periodontology, College of Dentistry, Dankook University, Cheonansi, Republic of Korea.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Periodontology, Periodontal-Implant Clinical Research Institute, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Yun', 'Initials': 'SY', 'LastName': 'Shin', 'Affiliation': 'Department of Periodontology, Periodontal-Implant Clinical Research Institute, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}]",Journal of clinical periodontology,['10.1111/jcpe.13223']
651,31174168,Nicotine or expectancies? Using the balanced-placebo design to test immediate outcomes of vaping.,"INTRODUCTION


Electronic (e-)cigarette use has increased in popularity, especially among those attempting to quit smoking. Previous studies evaluating the therapeutic efficacy of e-cigarettes have suggested that non-pharmacologic factors, such as expectancies about nicotine effects, may influence the experienced effects of e-cigarettes.
METHOD


The independent and synergistic influences of drug and expectancies were parsed using a balanced-placebo design, whereby 128 participants (52 dual users) were provided an e-cigarette that either contained nicotine or non-nicotine solution, while told that it did or did not contain nicotine. We hypothesized main effects of nicotine content on physiological, objective outcomes (attention, appetite, aversion, respiratory tract sensations), and main effects of the instructions on more subjective, psychosocial outcomes (affect, reward, satisfaction). Sex was included as a moderator.
RESULTS


Results showed that nicotine increased sustained attention, and more so among females. Nicotine delivery was associated with aversion among females, but not males. Among those who were both told and did not receive nicotine, higher enjoyment of respiratory tract sensations was reported. Nicotine with complementary instructions produced the highest reward ratings; additionally, nicotine was rewarding to males but not females.
DISCUSSION


Findings demonstrated that both nicotine content and non-pharmacologic factors impact acute outcome effects of e-cigarettes, with moderation by sex in some cases. Results are relevant to the interpretation of clinical trials of e-cigarettes and suggest a more nuanced view of reinforcement pathways.",2019,"We hypothesized main effects of nicotine content on physiological, objective outcomes (attention, appetite, aversion, respiratory tract sensations), and main effects of the instructions on more subjective, psychosocial outcomes (affect, reward, satisfaction).",['128 participants (52 dual users) were provided an e-cigarette that either contained'],"['balanced-placebo', 'nicotine or non-nicotine solution, while told that it did or did not contain nicotine', 'Nicotine', 'nicotine']","['sustained attention', 'physiological, objective outcomes (attention, appetite, aversion, respiratory tract sensations', 'enjoyment of respiratory tract sensations', 'highest reward ratings', 'subjective, psychosocial outcomes (affect, reward, satisfaction']","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",128.0,0.0348398,"We hypothesized main effects of nicotine content on physiological, objective outcomes (attention, appetite, aversion, respiratory tract sensations), and main effects of the instructions on more subjective, psychosocial outcomes (affect, reward, satisfaction).","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychology, University of South Florida, United States of America; Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, United States of America.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Psychology, University of South Florida, United States of America; Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, United States of America. Electronic address: thomas.brandon@moffitt.org.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.04.026']
652,31726990,Interpreter proxy versus healthcare interpreter for administration of patient surveys following arthroplasty: a pilot study.,"BACKGROUND


Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the language of the healthcare provider. Interpreter proxies (family and carers) are often used due to limited access to certified healthcare interpreters (due to cost or availability). The aim of this study was to assess the reliability of engaging interpreter proxies compared with certified healthcare interpreters for the administration of patient-reported health-related surveys for people with limited English proficiency (LEP).
METHODS


People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate. Participants were randomly allocated to having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview within 2 weeks (range: 4 to 12 days) after the first interview using the alternative method. Agreement between the two methods was assessed using quadratic weighted Cohen's kappa, intraclass correlation and concordance correlation co-efficient where appropriate for EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses. The mean of the differences between the same data items collected by each of the two methods was also calculated.
RESULTS


Eighty five participants (96%) completed the study. There was substantial to excellent inter-rater agreement (kappa = 0.69-0.87 and ICCs above 0.74) for all but one measure. The mean differences between family proxy and healthcare interpreter scores for each participant were small, ranging from 0.01 (score range of 1-5) to 0.72 (score range of 0-100).
CONCLUSION


These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.",2019,"These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.","['five participants (96%) completed the study', 'People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate', 'Eighty', 'patient-reported health-related surveys for people with limited English proficiency (LEP']",['having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview'],"['EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0150646', 'cui_str': 'Interpreter (occupation)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",85.0,0.051152,"These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Xue', 'Affiliation': 'South Western Sydney Clinical School, Faculty of Medicine, UNSW Australia, Liverpool Hospital, Liverpool, NSW, 2170, Australia. daniel.xue@health.nsw.gov.au.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Churches', 'Affiliation': 'South Western Sydney Clinical School, Faculty of Medicine, UNSW Australia, Liverpool Hospital, Liverpool, NSW, 2170, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'Falls, Balance and Injury Centre, Neuroscience Research Australia, 139 Barker St, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': 'South Western Sydney Clinical School, Faculty of Medicine, UNSW Australia, Liverpool Hospital, Liverpool, NSW, 2170, Australia.'}, {'ForeName': 'Justine Maree', 'Initials': 'JM', 'LastName': 'Naylor', 'Affiliation': 'South Western Sydney Clinical School, Faculty of Medicine, UNSW Australia, Liverpool Hospital, Liverpool, NSW, 2170, Australia.'}, {'ForeName': 'Ian Andrew', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'South Western Sydney Clinical School, Faculty of Medicine, UNSW Australia, Liverpool Hospital, Liverpool, NSW, 2170, Australia.'}]",BMC medical research methodology,['10.1186/s12874-019-0854-1']
653,31134707,Effectiveness and easiness of adherence to behavioural guidelines for diet and lifestyle changes for cholesterol-lowering: the Increasing Adherence of Consumers to Diet & Lifestyle Changes to Lower (LDL) Cholesterol (ACT) randomised controlled trial.,"BACKGROUND


The present study aimed to assess perceived effectiveness and easiness of behavioural diet and lifestyle changes related to dyslipidaemia given by physicians or dieticians as a result of diet and lifestyle modifications being difficult to maintain.
METHODS


One-hundred hypercholesterolaemic individuals were enrolled in a parallel, randomised 6-week study. Fifty were advised by dietitians (dietitian group: DG) in six weekly face-to-face behavioural therapy sessions and 50 received standard advice from physicians (physician group: PG). All individuals were followed-up for another 6 weeks under real-life conditions. Questionnaires regarding perceived effectiveness, easiness of adhering, forecasted and actual adherence to specific cholesterol-lowering advice were completed.
RESULTS


Scores of perceived effectiveness of advice for sufficient exercise, limiting saturated fat (SFA) intake, eating fish twice a week, consuming plenty of fresh fruit and vegetables, and limiting salt intake different scientifically (all P < 0.05) in PG and DG between study phases. Scores of the individuals' perception of effectiveness at all study phases were higher in the DG compared to PG for sufficient exercise, limiting SFA intake, eating fish twice a week, eating plenty of fruits and vegetables, and limiting salt intake, whereas scores of easiness were significant only for fish consumption (P = 0.008) and using foods with added plant sterols (all P < 0.05). DG and PG significantly differed in forecasted (week 6) versus actual adherence (week 12) to various chances, with DG reporting higher adherence.
CONCLUSIONS


Lifestyle and dietary changes related to dyslipidaemia can be achieved with continuous education, monitoring and follow-ups by dieticians, as well as potentially other trained healthcare professionals.",2019,"Scores of the individuals' perception of effectiveness at all study phases were higher in the DG compared to PG for sufficient exercise, limiting SFA intake, eating fish twice a week, eating plenty of fruits and vegetables, and limiting salt intake, whereas scores of easiness were significant only for fish consumption (P = 0.008) and using foods with added plant sterols (all P < 0.05).","['One-hundred hypercholesterolaemic individuals', 'Consumers to Diet & Lifestyle Changes to Lower (LDL) Cholesterol (ACT']",['dietitians (dietitian group: DG) in six weekly face-to-face behavioural therapy sessions and 50 received standard advice from physicians (physician group: PG'],"['saturated fat (SFA) intake, eating fish twice a week, consuming plenty of fresh fruit and vegetables, and limiting salt intake different scientifically', 'DG and PG', 'effectiveness, easiness of adhering, forecasted and actual adherence to specific cholesterol-lowering advice']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit (substance)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",50.0,0.034883,"Scores of the individuals' perception of effectiveness at all study phases were higher in the DG compared to PG for sufficient exercise, limiting SFA intake, eating fish twice a week, eating plenty of fruits and vegetables, and limiting salt intake, whereas scores of easiness were significant only for fish consumption (P = 0.008) and using foods with added plant sterols (all P < 0.05).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magriplis', 'Affiliation': 'Department of Food Science and Human Nutrition, School of Food, Biotechnology and Development, Agricultural University of Athens, Athens, Greece.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Sialvera', 'Affiliation': 'Department of Food Science and Human Nutrition, School of Food, Biotechnology and Development, Agricultural University of Athens, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papadopoulou', 'Affiliation': 'Center for Cardiovascular Disease Prevention, Hygeias Melathron Infirmary, Athens, Greece.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Efstathiou', 'Affiliation': 'Center for Cardiovascular Disease Prevention, Hygeias Melathron Infirmary, Athens, Greece.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Trautwein', 'Affiliation': 'Unilever R&D, Vlaardingen, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Goumas', 'Affiliation': 'Department of Cardiology, Euroclinic, Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Dimakopoulos', 'Affiliation': 'Department of Food Science and Human Nutrition, School of Food, Biotechnology and Development, Agricultural University of Athens, Athens, Greece.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papavasiliou', 'Affiliation': 'Department of Food Science and Human Nutrition, School of Food, Biotechnology and Development, Agricultural University of Athens, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koutsouri', 'Affiliation': 'Errikos Dunant Hospital Centre, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zampelas', 'Affiliation': 'Department of Food Science and Human Nutrition, School of Food, Biotechnology and Development, Agricultural University of Athens, Athens, Greece.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12667']
654,31112380,Early Sedation with Dexmedetomidine in Critically Ill Patients.,"BACKGROUND


Dexmedetomidine produces sedation while maintaining a degree of arousability and may reduce the duration of mechanical ventilation and delirium among patients in the intensive care unit (ICU). The use of dexmedetomidine as the sole or primary sedative agent in patients undergoing mechanical ventilation has not been extensively studied.
METHODS


In an open-label, randomized trial, we enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives). The target range of sedation-scores on the Richmond Agitation and Sedation Scale (which is scored from -5 [unresponsive] to +4 [combative]) was -2 to +1 (lightly sedated to restless). The primary outcome was the rate of death from any cause at 90 days.
RESULTS


We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization. In a modified intention-to-treat analysis involving 3904 patients, the primary outcome event occurred in 566 of 1948 (29.1%) in the dexmedetomidine group and in 569 of 1956 (29.1%) in the usual-care group (adjusted risk difference, 0.0 percentage points; 95% confidence interval, -2.9 to 2.8). An ancillary finding was that to achieve the prescribed level of sedation, patients in the dexmedetomidine group received supplemental propofol (64% of patients), midazolam (3%), or both (7%) during the first 2 days after randomization; in the usual-care group, these drugs were administered as primary sedatives in 60%, 12%, and 20% of the patients, respectively. Bradycardia and hypotension were more common in the dexmedetomidine group.
CONCLUSIONS


Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that in the usual-care group and required supplemental sedatives to achieve the prescribed level of sedation. More adverse events were reported in the dexmedetomidine group than in the usual-care group. (Funded by the National Health and Medical Research Council of Australia and others; SPICE III ClinicalTrials.gov number, NCT01728558.).",2019,More adverse events were reported in the dexmedetomidine group than in the usual-care group.,"['patients in the intensive care unit (ICU', 'enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive', 'We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization', 'patients undergoing mechanical ventilation in the ICU, those who received early', 'patients undergoing mechanical ventilation', 'Critically Ill Patients']","['Dexmedetomidine', 'midazolam', 'supplemental propofol', 'dexmedetomidine', 'dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives']","['rate of death', 'Bradycardia and hypotension', 'adverse events', 'rate of death from any cause at 90 days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",4000.0,0.143883,More adverse events were reported in the dexmedetomidine group than in the usual-care group.,"[{'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Belinda D', 'Initials': 'BD', 'LastName': 'Howe', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Bass', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Suhaini', 'Initials': 'S', 'LastName': 'Bin Kadiman', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Reade', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Seppelt', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Takala', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': ""From the School of Clinical Sciences (Y.S.) and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (B.D.H., R.B., M.B., L.M., S.A.W.), Monash University, Monash Health (Y.S.), the Faculty of Medicine, University of Melbourne (R.B., M.B.), Melbourne, VIC, and Austin Hospital, Heidelberg, VIC (R.B.), the Prince of Wales Clinical School of Medicine, University of New South Wales (Y.S.), Royal North Shore Hospital, the George Institute for Global Health (F.E.B.), the Sydney Medical School-Nepean, University of Sydney, and the Department of Clinical Medicine, Macquarie University (I.M.S.), Sydney, the Faculty of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane (M.C.R.), the Joint Health Command, Australian Defence Force, Canberra, ACT (M.C.R.), and St. John of God Subiaco Hospital, Subiaco, WA (S.A.W.) - all in Australia; the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia (Y.M.A.); the Department of Anesthesiology and Intensive Care, IJN-UTM Cardiovascular Engineering Center, National Heart Institute, Kuala Lumpur, Malaysia (S.B.K.); the Department of Critical Care Medicine, Auckland City Hospital, University of Auckland, Auckland, New Zealand (C.J.M.); Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (J.T.); and Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom (M.P.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1904710']
655,31096265,The Relationship of Varenicline Agonism of α4β2 Nicotinic Acetylcholine Receptors and Nicotine-Induced Dopamine Release in Nicotine-Dependent Humans.,"INTRODUCTION


Cigarette smoking continues to be one of the most important behavioral causes of morbidity and mortality in the world. Varenicline, an α4β2 nicotinic acetylcholine receptor (nAChR) partial agonist, has been shown to increase smoking quit rates compared with nicotine-based products. This human laboratory, double-blind, placebo-controlled study examined varenicline and placebo effects on α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride non-displaceable binding potential (BPND), and behavioral measures of cigarette smoking, nicotine craving, and withdrawal.
METHODS


Current nicotine dependent daily smokers (N = 17) were randomized to varenicline 1 mg twice daily or placebo for 13 days. Using positron emission tomography), we characterized α4β2-nAChRs occupancy using [18F]AZAN and dopamine receptor binding using [11C]raclopride as well as behavioral measures of cigarettes smoked, craving, and nicotine withdrawal.
RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen, and ventral striatum. Following administration of a controlled-dose nicotine cigarette, dopamine release was significantly suppressed in the ventral striatum in the varenicline-treated compared with the placebo group. There was a significant relationship between α4β2-nAChRs BPND measured in thalamus during the [18F]AZAN scan and nicotine-induced change in raclopride BPND in the ventral striatum.
CONCLUSION


This is the first human study to demonstrate a direct relationship between the extent of varenicline occupancy of α4β2-nAChRs and the magnitude of dopamine release following nicotine use.
IMPLICATIONS


It has remained unclear how nicotinic receptor blockade through partial agonist medications such as varenicline promotes smoking cessation. One hypothesized mechanism is downstream dampening of the mesolimbic reward dopamine system. For the first time in human smokers, we observed a direct relationship between the extent of varenicline blockade of α4β2-nACh nicotinic receptors and the magnitude of dopamine release following smoking. This has mechanistic and therapeutic implications for improving smoking cessation interventions.",2020,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","['Current nicotine dependent, daily smokers (N=17', 'human smokers']","['Varenicline', 'placebo', 'varenicline 1 mg twice daily or placebo', 'varenicline and placebo', 'positron emission tomography (PET']","['18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum', 'α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride binding potential (BPND) and behavioral measures of cigarette smoking, nicotine craving, and withdrawal', 'ventral striatum', 'raclopride BPND', 'smoking quit rates', 'α4β2-nAChRs BPND']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1712046', 'cui_str': 'varenicline 1 MG [Chantix]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0025462', 'cui_str': 'Midbrain'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0872355', 'cui_str': 'Nicotine craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",17.0,0.0570948,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'McCaul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Wand', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Dannals', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz080']
656,31742685,Modular cognitive-behavioral therapy for affective symptoms in young individuals at ultra-high risk of first episode of psychosis: Randomized controlled trial.,"OBJECTIVES


Individuals at ultra-high risk of psychosis often present concurrent affective symptoms (depression/anxiety). This study investigated whether modular cognitive-behavioral therapy (CBT) targeting both ultra-high risk and affective symptoms (a) reduced/delayed risk of a first psychotic episode at posttreatment and 14-month follow-up compared with a supportive intervention, (b) was more effective than control condition in producing remission on depression/anxiety.
METHODS


Fifty-eight ultrahigh risk individuals were randomly assigned to CBT or control condition. CBT consisted of 30 sessions, including CBT for psychotic experiences and depression/anxiety.
RESULTS


In the CBT group, the cumulative number of participants who developed a first psychotic episode (n = 3, 10.34%) at follow-up was lower than in the control group (n = 8, 27.60%; logrank χ 2   (1)   = 3.68, p = .05). In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
CONCLUSION


CBT can prevent psychosis risk and produce better outcomes on depression/anxiety than supportive intervention.",2020,"In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
","['young individuals at ultra-high risk of first episode of psychosis', 'Individuals at ultra-high risk of psychosis often present concurrent affective symptoms (depression/anxiety', 'Fifty-eight', 'ultrahigh risk individuals']","['Modular cognitive-behavioral therapy', 'CBT', 'modular cognitive-behavioral therapy (CBT']","['affective symptoms', 'delayed risk of a first psychotic episode', 'cumulative number of participants who developed a first psychotic episode']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0338614'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0437043,"In the CBT group, a higher number of participants achieved remission than in control condition on affective symptoms at posttreatment/follow-up.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pozza', 'Affiliation': 'Department of Health Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Dèttore', 'Affiliation': 'Department of Health Sciences, University of Florence, Florence, Italy.'}]",Journal of clinical psychology,['10.1002/jclp.22901']
657,31094935,"Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial.","OBJECTIVE


Central venous catheter (CVC) insertion is a common practice for anesthetists, but this invasive procedure generates anxiety and pain in patients that are often underestimated. We compared target-controlled infusion of remifentanil and local lidocaine infiltration with placebo and local lidocaine infiltration to decrease pain scores during CVC placement.
MATERIALS AND METHODS


We included conscious, adult patients without contraindication to remifentanil or lidocaine. We excluded pregnant women, emergency situations, and opioid abuse. Patients requiring CVC were randomly assigned, using computer-generated allocation numbers stored in sealed envelopes, to receive target-controlled infusion of remifentanil or placebo-all patients received local anesthesia with lidocaine. All patients were hospitalized in a recovery room or intensive care unit, monitored, and received 4 L/min of oxygen.The primary outcome was global pain (Verbal Numeric Rating Pain Scale) during the procedure. Secondary outcomes were pain perceived at every stage of the procedure, anxiety, patient satisfaction, operational ease, and side effects.
RESULTS


In this double-blind study, we included 90 patients (split into 2 groups of 45 patients). Global pain was significantly reduced in the remifentanil group: 20 of 100 (95% confidence interval, 16-40) versus 50 of 100 (95% confidence interval, 40-60) in the placebo group; P=0.0009. No major adverse events were observed during this study, and there were no significant differences between both groups regarding side effects.
DISCUSSION


Target-controlled infusion of remifentanil is an effective drug to reduce pain during CVC insertion in association with lidocaine-based local anesthesia, in conscious patients.",2019,"Global pain was significantly reduced in the remifentanil group: 20 of 100 (95% confidence interval, 16-40) versus 50 of 100 (95% confidence interval, 40-60) in the placebo group; P=0.0009.","['We included conscious, adult patients without contraindication to', 'Patients requiring CVC', 'Central Venous Catheter Insertion', 'All patients were hospitalized in a recovery room or intensive care unit, monitored, and received 4\u2009L/min of oxygen', '90 patients (split into 2 groups of 45 patients', 'conscious patients', 'pregnant women, emergency situations, and opioid abuse']","['lidocaine', 'placebo and local lidocaine', 'Central venous catheter (CVC) insertion', 'remifentanil or lidocaine', 'remifentanil', 'Remifentanil', 'remifentanil and local lidocaine', 'computer-generated allocation numbers stored in sealed envelopes, to receive target-controlled infusion of remifentanil or placebo-all patients received local anesthesia with lidocaine']","['global pain (Verbal Numeric Rating Pain Scale', 'Global pain', 'adverse events', 'side effects', 'pain scores', 'pain perceived at every stage of the procedure, anxiety, patient satisfaction, operational ease, and side effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0029095', 'cui_str': 'Opioid abuse (disorder)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",90.0,0.743413,"Global pain was significantly reduced in the remifentanil group: 20 of 100 (95% confidence interval, 16-40) versus 50 of 100 (95% confidence interval, 40-60) in the placebo group; P=0.0009.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Vardon Bounes', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pichon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Ducos', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Ruiz', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Samier', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Sommet', 'Affiliation': 'Methodological Support Unit for Clinical Research, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fourcade', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Conil', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Minville', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, University Hospital of Toulouse, University Toulouse III-Paul-Sabatier.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000725']
658,31760109,Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial.,"Opioid prescription in the treatment of chronic pain is frequent and carries a risk of increased morbidity and mortality in a clinically significant number of patients, particularly those who are using opioids in a hazardous manner. Few treatment options are available that target both pain-related interference and hazardous opioid use among patients with chronic pain. In military Veterans, this issue is of particular importance as numerous reports indicate continued high rates of opioid prescription for chronic pain, as well as significant opioid-related problems. The overall aim of the present study was to determine the feasibility of an integrated psychosocial treatment in Veterans with chronic pain, who also have evidence of hazardous opioid use. To examine this aim, a random design was used to assess the feasibility and initial efficacy of integrating 2 empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for opioid misuse. Half of participants were randomized to the integrated treatment group and all participants received usual care through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse. In total, 37 participants were randomized and included in intent-to-treat analyses and 32 individuals were included in per protocol analyses with 6-month follow-up serving as the primary study endpoint. Feasibility indicators included recruitment, retention, and treatment completion rates. Recruitment fell short of targeted enrollment, although retention and completion were excellent. Primary outcome measures were opioid misuse, pain interference, and pain behavior. Simultaneous multiple regression analyses controlled for pain duration, baseline opioid dose, and baseline value for outcome measures. Results of both the intent-to-treat and per protocol indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior. Results support the feasibility of providing an integrated treatment for both opioid risk and pain interference. PERSPECTIVE: Opioid misuse occurs in some opioid-prescribed individuals with chronic pain. Few treatment options exist that target both pain interference and opioid misuse. This study examined feasibility and initial efficacy of an integrated behavioral treatment for Veterans. Feasibility was supported, except recruitment. Efficacy was supported compared to usual care.",2020,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","['military Veterans', 'Veterans with co-morbid chronic pain and hazardous opioid use', 'Veterans', '37 participants were randomized and included in intent to treat (ITT) analyses and 32 individuals were included in per protocol (PP) analyses with 6-month follow-up serving as the primary study endpoint', 'individuals with chronic pain', 'patients with chronic pain', 'Veterans with chronic pain, who also have evidence of hazardous opioid use']","['Opioid prescription', 'integrated behavioral treatment', 'integrated psychosocial treatment', 'Integrated behavioral treatment', ""usual care (UC) through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse""]","['opioid misuse, pain interference, and pain behavior', 'recruitment, retention, and treatment completion rates', 'Efficacy', 'feasibility and initial efficacy']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041735', 'cui_str': 'United States. Dept. of Veterans Affairs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",37.0,0.0734594,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","[{'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vowles', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Cusack', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Wesley P', 'Initials': 'WP', 'LastName': 'Gilliam', 'Affiliation': 'Pain Rehabilitation Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Cardon', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Department of Psychology, Pacific University, Forest Grove, Oregon.'}, {'ForeName': 'Karlyn A', 'Initials': 'KA', 'LastName': 'Edwards', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Mindy L', 'Initials': 'ML', 'LastName': 'McEntee', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Bailey', 'Affiliation': 'Swedish Pain Services, Swedish Health System, Seattle, Washington.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.007']
659,29520735,Neonatal outcomes among twins stratified by method of conception: secondary analysis of maternal fetal medicine (MFMU) network database.,"PURPOSE


To investigate whether twin pregnancies conceived by different forms of fertility treatments are associated with adverse neonatal outcomes and to examine the difference in maternal and obstetrical characteristics between patients.
METHODS


Our study was a retrospective analysis of twin pregnancies conceived by fertility treatments from a prospectively collected database. Treatments were stratified into two groups: group 1 (ART) consisted of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), and group 2 (non-ART) included intrauterine insemination (IUI) and ovulation induction (OI). Composite neonatal morbidity included respiratory distress syndrome, intraventricular hemorrhage, leukomalacia, chronic lung disease, and death prior to discharge.
RESULTS


There were 460 neonates in our study; among them, 67% (n = 310) were in group 1, and 33% (n = 150) in group 2. Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001). In multivariable Poisson regression model, only neonatal intensive care unit admission rate was increased for group 1 twins (aRR = 1.27, 95% CI 1.003-1.60).
CONCLUSIONS


After adjusting for confounders, twins conceived via ART compared to non-ART had similar neonatal outcomes. These data can help when counseling this patient population and assist in planning larger prospective cohorts.",2018,"Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001).","['twin pregnancies conceived by fertility treatments from a prospectively collected database', '460 neonates in our study; among them, 67% (n\u2009=\u2009310', 'twins stratified by method of conception: secondary analysis of maternal fetal medicine (MFMU) network database', 'twin pregnancies']","['group 1 (ART) consisted of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), and group 2 (non-ART) included intrauterine insemination (IUI) and ovulation induction (OI']","['neonatal intensive care unit admission rate', 'delivered twins with lower birth weights', 'respiratory distress syndrome, intraventricular hemorrhage, leukomalacia, chronic lung disease, and death prior to discharge']","[{'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}]","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",,0.242173,"Group 1 patients were more likely to be older (p = 0.004), nulliparous (p = 0.01), delivered twins with lower birth weights (2278 g ± 605 vs. 2427 ± 519, p = 0.009), and had more deliveries < 32 weeks gestation (p = 0.001).","[{'ForeName': 'Jaimin S', 'Initials': 'JS', 'LastName': 'Shah', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA. Jaimin.Shah@uth.tmc.edu.'}, {'ForeName': 'Susan Hosseini', 'Initials': 'SH', 'LastName': 'Nasab', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Chappell', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics & Gynecology, McGovern Medical School at the University of Texas Health Science Center, 6431 Fannin St, Suite 3.214, Houston, TX, 77030, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schutt', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Mendez-Figueroa', 'Affiliation': 'Department of Maternal & Fetal Medicine, McGovern Medical School at the University of Texas Health Science Center, Houston, TX, USA.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-018-1149-x']
660,31749113,"Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study.","BACKGROUND


Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs.
OBJECTIVE


We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients.
METHODS


The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10-12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly.
RESULTS


A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4% vs. 66.2% in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups.
CONCLUSION


The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.",2020,"In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups.
","['24 centers in Korea between June 2015 and June 2017', 'A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation', 'Patients on Hemodialysis', 'patients undergoing hemodialysis', 'hemodialysis patients']","['ESA', 'darbepoetin-alfa', 'CKD-11101', 'CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa', 'Darbepoetin-Alfa', 'intravenous CKD-11101', 'darbepoetin-alfa or CKD-11101 weekly or biweekly']","['hemoglobin (Hb) stability', 'efficacy and safety', 'level of Hb, dose of erythropoietin, and achievement rate of the target Hb', 'average Hb level']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C3472649', 'cui_str': 'ESAS'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",403.0,0.0982215,"In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups.
","[{'ForeName': 'Yaerim', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Keimyung University School of Medicine, 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Korea.'}, {'ForeName': 'Su-Kil', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Yong', 'Initials': 'WY', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Korea University Medical College, Seoul, Korea.'}, {'ForeName': 'Kwon Wook', 'Initials': 'KW', 'LastName': 'Joo', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sug Kyun', 'Initials': 'SK', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital, Goyang, Gyeonggi-do, Korea.'}, {'ForeName': 'Dae Joong', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Son', 'Affiliation': 'Department of Internal Medicine, Suyeong Hanseo Hospital, Busan, Korea.'}, {'ForeName': 'Wookyung', 'Initials': 'W', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Gil Medical Center, Gachon University of Medicine and Science, Seongnam, Korea.'}, {'ForeName': 'Kwang Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.'}, {'ForeName': 'Sung Kwang', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Medical School, Jeonju, Korea.'}, {'ForeName': 'Joong Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Bong Seng Hospital, Busan, Korea.'}, {'ForeName': 'Soo Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.'}, {'ForeName': 'Duk-Hee', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Kuk', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.'}, {'ForeName': 'Jin Seok', 'Initials': 'JS', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kang Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Chang Hwa', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong-Jin', 'Initials': 'DJ', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Won Suk', 'Initials': 'WS', 'LastName': 'An', 'Affiliation': 'Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jong Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea.'}, {'ForeName': 'Gun Woo', 'Initials': 'GW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Do', 'Affiliation': 'Department of Internal Medicine, Yeungnam University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jung Pyo', 'Initials': 'JP', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and SMG-SNU Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Kyubok', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Keimyung University School of Medicine, 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Korea. mdjin922@gmail.com.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00396-9']
661,31739785,Randomised controlled trial of an intervention to improve parental knowledge and management practices of fever.,"BACKGROUND


We know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition.
METHODS


A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C).
RESULTS


A total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified ""higher than ≥38°C"" as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3-19.9: p < 0.01; T2: OR 10.5; CI 95% 3.4-32.0: p < 0.01).
CONCLUSIONS


Our RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02903342, September 16, 2016, Retrospectively registered.",2019,A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1.,"['children', '100 parents participated in the study at T1', 'Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate']",[],"['fever information leaflet', 'parental knowledge and management practices of fever', 'correct definition of fever', 'correct temperature']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",100.0,0.13531,A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Medicine, University College Cork, Cork, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mc Gillicuddy', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'Trials Research and Methodologies Group (TRAMS), HRB Clinical Research Facility, Mercy University Hospital, Cork, Ireland. f.shiely@ucc.ie.'}]",BMC pediatrics,['10.1186/s12887-019-1808-9']
662,31003798,Two-year outcomes of a randomized controlled trial of transepithelial corneal crosslinking with iontophoresis for keratoconus.,"PURPOSE


To evaluate the 2-year clinical outcomes of corneal crosslinking (CXL) using transepithelial iontophoresis CXL (T-ionto CXL) in comparison with standard CXL for the treatment of progressive keratoconus.
SETTING


Single-site study.
DESIGN


Randomized controlled clinical trial with identifier code NCT02117999.
METHODS


The eyes of the participants were randomized to have either T-ionto CXL and/or standard CXL. Assessments of uncorrected (UDVA) and corrected (CDVA) distance visual acuities (logarithm of the minimum angle of resolution [logMAR]), manifest refraction spherical equivalent, maximum simulated keratometry (K) (diopters [D]), corneal higher-order aberrations (HOAs), central corneal thickness (CCT), and endothelial cell density (ECD) were performed at 3 days, 7 days, and 1, 3, 6, 12, and 24 months postoperatively.
RESULTS


The study comprised 34 eyes (25 patients). There were 22 eyes in the T-ionto CXL group and 12 eyes in the standard CXL group. Two years after T-ionto CXL and standard CXL, the mean maximum K flattened by -1.05 ± 1.20 D (P = .07) (20 eyes) and -1.51 ± .89 D (P < .001) (11 eyes), respectively. Two study cases (10%) and no control showed maximum K steepening of more than 1.0 D at 24 months postoperatively. The mean change in CDVA was -0.08 ± 0.15 logMAR (P = .04) and -0.02 ± 0.06 logMAR (P = .34) after T-ionto CXL and standard CXL, respectively. A significant average decrease in the myopic defocus (+0.81 D; P < .05) was found in both groups. No significant differences in the outcome measures between treatments were found at 24 months. The corneal HOAs, CCT, and ECD values did not change significantly in any group at 2 years postoperatively.
CONCLUSIONS


Clinically significant topographic, visual, and refractive improvements were found 2 years after T-ionto CXL; standard CXL showed more significant corneal apex flattening than the transepithelial iontophoresis protocol.",2019,A significant average decrease in the myopic defocus (+0.81 D; P < .05) was found in both groups.,"['34 eyes (25 patients', 'Single-site study']","['standard CXL', 'corneal crosslinking (CXL', 'T-ionto CXL and/or standard CXL', 'transepithelial corneal crosslinking with iontophoresis', 'transepithelial iontophoresis CXL (T-ionto CXL']","['corneal apex flattening', 'corneal HOAs, CCT, and ECD values', 'Assessments of uncorrected (UDVA) and corrected (CDVA) distance visual acuities (logarithm of the minimum angle of resolution [logMAR]), manifest refraction spherical equivalent, maximum simulated keratometry (K) (diopters [D]), corneal higher-order aberrations (HOAs), central corneal thickness (CCT), and endothelial cell density (ECD', 'mean change in CDVA', 'maximum K steepening']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",34.0,0.0472927,A significant average decrease in the myopic defocus (+0.81 D; P < .05) was found in both groups.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lombardo', 'Affiliation': 'Vision Engineering Italy srl, Rome, Italy; Studio Italiano di Oftalmologia, Rome, Italy. Electronic address: mlombardo@visioeng.it.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serrao', 'Affiliation': 'Studio Italiano di Oftalmologia, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lombardo', 'Affiliation': 'Vision Engineering Italy srl, Rome, Italy; Consiglio Nazionale delle Ricerche, Istituto per i Processi Chimico-Fisici, Messina, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Fondazione G.B. Bietti IRCCS, Rome, Italy.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.01.026']
663,31680269,Routine glucose assessment in the emergency department for detecting unrecognised diabetes: a cluster randomised trial.,"OBJECTIVE


To determine whether routine blood glucose assessment of patients admitted to hospital from emergency departments (EDs) results in higher rates of new diagnoses of diabetes and documentation of follow-up plans.
DESIGN, SETTING


Cluster randomised trial in 18 New South Wales public district and tertiary hospitals, 31 May 2011 - 31 December 2012; outcomes follow-up to 31 March 2016.
PARTICIPANTS


Patients aged 18 years or more admitted to hospital from EDs.
INTERVENTION


Routine blood glucose assessment at control and intervention hospitals; automatic requests for glycated haemoglobin (HbA 1c  ) assessment and notification of diabetes services about patients at intervention hospitals with blood glucose levels of 14 mmol/L or more.
MAIN OUTCOME MEASURE


New diagnoses of diabetes and documented follow-up plans for patients with admission blood glucose levels of 14 mmol/L or more.
RESULTS


Blood glucose was measured in 133 837 patients admitted to hospital from an ED. The numbers of new diabetes diagnoses with documented follow-up plans for patients with blood glucose levels of 14 mmol/L or more were similar in intervention (83/506 patients, 16%) and control hospitals (73/278, 26%; adjusted odds ratio [aOR], 0.83; 95% CI 0.42-1.7; P = 0.61), as were new diabetes diagnoses with or without plans (intervention, 157/506, 31%; control, 86/278, 31%; aOR, 1.51; 95% CI, 0.83-2.80; P = 0.18). 30-day re-admission (31% v 22%; aOR, 1.34; 95% CI, 0.86-2.09; P = 0.21) and post-hospital mortality rates (24% v 22%; aOR, 1.07; 95% CI, 0.74-1.55; P = 0.72) were also similar for patients in intervention and control hospitals.
CONCLUSION


Glucose and HbA 1c  screening of patients admitted to hospital from EDs does not alone increase detection of previously unidentified diabetes. Adequate resourcing and effective management pathways for patients with newly detected hyperglycaemia and diabetes are needed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12611001007921.",2019,"30-day re-admission (31% v 22%; aOR, 1.34; 95% CI, 0.86-2.09; P = 0.21) and post-hospital mortality rates (24% v 22%; aOR, 1.07; 95% CI, 0.74-1.55; P = ","['patients admitted to hospital from emergency departments (EDs', 'patients with newly detected hyperglycaemia and diabetes', '133\xa0837 patients admitted to hospital from an ED', 'patients at intervention hospitals with blood glucose levels of 14\xa0mmol/L or more', 'Cluster randomised trial in 18 New South Wales public district and tertiary hospitals, 31 May 2011 - 31 December 2012; outcomes follow-up to 31 March 2016', 'Patients aged 18 years or more admitted to hospital from EDs']",[],"['blood glucose levels', 'numbers of new diabetes diagnoses', '30-day re-admission', 'Blood glucose', 'post-hospital mortality rates', 'glycated haemoglobin (HbA 1c  ) assessment and notification of diabetes services', 'admission blood glucose levels of 14\xa0mmol/L or more']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]",,0.0639248,"30-day re-admission (31% v 22%; aOR, 1.34; 95% CI, 0.86-2.09; P = 0.21) and post-hospital mortality rates (24% v 22%; aOR, 1.07; 95% CI, 0.74-1.55; P = ","[{'ForeName': 'N Wah', 'Initials': 'NW', 'LastName': 'Cheung', 'Affiliation': 'Westmead Hospital, Sydney, NSW.'}, {'ForeName': 'Lesley V', 'Initials': 'LV', 'LastName': 'Campbell', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW.""}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital, Sydney, NSW.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McElduff', 'Affiliation': 'University of Newcastle, Newcastle, NSW.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Depczynski', 'Affiliation': 'Prince of Wales Private Hospital, Sydney, NSW.'}, {'ForeName': 'Shamasunder', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'John Hunter Hospital, Newcastle, NSW.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Hornsby Hospital, Sydney, NSW.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Champion', 'Affiliation': 'Nepean Hospital, Penrith, NSW.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Concord Repatriation General Hospital, Sydney, NSW.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chipps', 'Affiliation': 'Westmead Hospital, Sydney, NSW.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Flack', 'Affiliation': 'Bankstown-Lidcombe Hospital, Sydney, NSW.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Kinsella', 'Affiliation': 'Ryde Hospital, Sydney, NSW.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Layton', 'Affiliation': 'Gosford Hospital, Gosford, NSW.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McLean', 'Affiliation': 'Western Sydney University School of Medicine, Penrith, NSW.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Moses', 'Affiliation': 'Wollongong Hospital, Wollongong, NSW.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Nepean Hospital, Penrith, NSW.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Poynten', 'Affiliation': 'Prince of Wales Private Hospital, Sydney, NSW.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'University of Sydney, Sydney, NSW.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Scadden', 'Affiliation': 'Murrumbidgee Local Health District, Wagga Wagga, NSW.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Tonks', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, NSW.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Webber', 'Affiliation': 'Ryde Hospital, Sydney, NSW.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'White', 'Affiliation': 'Prince of Wales Private Hospital, Sydney, NSW.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'Liverpool Hospital, Sydney, NSW.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""St Vincent's Health Australia, Sydney, NSW.""}]",The Medical journal of Australia,['10.5694/mja2.50394']
664,31733362,The Context of Values in Pain Control: Understanding the Price Effect in Placebo Analgesia.,"The experience of pain relief arises from physiological and psychological factors, and attributes such as the commercial features of analgesic treatments have been shown to influence placebo analgesia by affecting treatment expectations. Therefore, treatment valuation from price information should influence the placebo analgesic effect. This hypothesis was tested in a functional magnetic resonance imaging study in which healthy subjects were enrolled in a 2-day experiment. On day 1, the participants (n = 19) had treatment experiences with 2 different placebo creams during a conditioning session without receiving information on treatment price. On day 2, placebo analgesia was tested after providing price information (high vs low) while functional magnetic resonance imaging was performed. The results showed that the higher priced placebo treatment leads to enhanced pain relief. Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex, and ventral tegmental area. The behavioral results indicate that the experience of pain was influenced by treatment valuation from price. Our findings reveal that the context of values in pain control is associated with activity in expectation- and reward-related circuitry. PERSPECTIVE: Treatment with higher price was associated with enhanced placebo analgesia, and this effect was influenced by activities in expectation and reward processing brain areas. The context of value such as medical cost influences cognitive evaluation processes to modulate pain. Our study may help evaluate a patient's preference toward high-priced drugs.",2020,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.",['healthy subjects'],"['placebo', 'placebo analgesia', 'placebo creams', 'Placebo analgesia']","['pain relief', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.152627,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.","[{'ForeName': 'Ye-Seul', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam, South Korea.'}, {'ForeName': 'Won-Mo', 'Initials': 'WM', 'LastName': 'Jung', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, Essen University Hospital, Essen, Germany.'}, {'ForeName': 'Younbyoung', 'Initials': 'Y', 'LastName': 'Chae', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Neurology, Essen University Hospital, Essen, Germany. Electronic address: ybchae@khu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.005']
665,31025894,"Effect of Curcumin Supplementation on Exercise-Induced Oxidative Stress, Inflammation, Muscle Damage, and Muscle Soreness.","Curcumin has been shown to reduce exercise-induced oxidative stress (OS) and inflammation. The purpose of this investigation was to examine the effects of curcumin supplementation on OS, inflammation, muscle damage, and muscle soreness. Nineteen males participated in a randomized, double-blinded, placebo-controlled trial to examine the effects of curcumin supplementation (1.5 g/day) compared to a placebo (PLA) following a muscle-damaging protocol (MDP) on OS, inflammation, muscle damage, and soreness. Participants were randomized to two groups, curcumin or placebo group. The MDP was performed before and after supplementation (28 days). Blood was sampled pre- and postexercise and 60 min, 24 h, and 48 h postexercise and analyzed for total antioxidant capacity (TAC), malondialdehyde (MDA), tumor necrosis factor alpha (TNF-α), and creatine kinase (CK). In addition, a visual analog scale (VAS) was used on each blood sample to measure perceived muscle soreness. After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall ( p  < 0.0001). In addition, curcumin resulted in decreased muscle soreness, overall (VAS scale 2.88), when compared to the placebo (VAS scale 3.36) ( p  = 0.0120). There were no differences found in TAC, TNF-α, or MDA. Curcumin may reduce muscle damage and perceived muscle soreness without negatively impacting a natural inflammatory response following exercise. Future research should investigate chronic curcumin supplementation and its mechanistic effects on muscle recovery from exercise.",2020,"After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall (p < 0.0001).",['Nineteen males'],"['placebo', 'curcumin supplementation', 'Curcumin Supplementation', 'curcumin or placebo', 'placebo (PLA']","['muscle soreness, overall (VAS scale 2.88', 'total antioxidant capacity (TAC), malondialdehyde (MDA), tumor necrosis factor alpha (TNF-α), and creatine kinase (CK', 'OS, inflammation, muscle damage, and soreness', 'visual analog scale (VAS', 'OS, inflammation, muscle damage, and muscle soreness', 'Exercise-Induced Oxidative Stress, Inflammation, Muscle Damage, and Muscle Soreness', 'TAC, TNF-α, or MDA', 'blunted CK levels']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",19.0,0.331652,"After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall (p < 0.0001).","[{'ForeName': 'Steven A Basham', 'Initials': 'SAB', 'LastName': 'Ms', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Ben M', 'Initials': 'BM', 'LastName': 'Krings PhD', 'Affiliation': 'Department of Health and Human Performance, University of Wisconsin-Platteville, Platteville, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lamberth PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'JohnEric W', 'Initials': 'JW', 'LastName': 'Smith PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McAllister PhD', 'Affiliation': 'Department of Health and Human Performance, Texas State University, San Marcos, TX, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1604604']
666,31389835,"Comparing the McGrath Mac Video Laryngoscope and Direct Laryngoscopy for Prehospital Emergency Intubation in Air Rescue Patients: A Multicenter, Randomized, Controlled Trial.","OBJECTIVES


Tracheal intubation in prehospital emergency care is challenging. The McGrath Mac Video Laryngoscope (Medtronic, Minneapolis, MN) has been proven to be a reliable alternative for in-hospital airway management. This trial compared the McGrath Mac Video Laryngoscope and direct laryngoscopy for the prehospital setting.
DESIGN


Multicenter, prospective, randomized, controlled equivalence trial.
SETTING


Oesterreichischer Automobil- und Touring Club (OEAMTC) Helicopter Emergency Medical Service in Austria, 18-month study period.
PATIENTS


Five-hundred fourteen adult emergency patients (≥ 18 yr old).
INTERVENTIONS


Helicopter Emergency Medical Service physicians followed the institutional algorithm, comprising a maximum of two tracheal intubation attempts with each device, followed by supraglottic, then surgical airway access in case of tracheal intubation failure. No restrictions were given for tracheal intubation indication.
MEASUREMENTS MAIN RESULTS


The Primary outcome was the rate of successful tracheal intubation; equivalence range was ± 6.5% of success rates. Secondary outcomes were the number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems. The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39). There was no statistically significant difference with regard to tracheal intubation times, number of attempts or difficulty. The view to the glottis was significantly better, but the number of technical problems was increased with the McGrath Mac Video Laryngoscope. After a failed first tracheal intubation attempt, immediate switching of the device was significantly more successful than after the second attempt (90.5% vs 57.1%; p = 0.0003), regardless of the method.
CONCLUSIONS


Both devices are equivalently well suited for use in prehospital emergency tracheal intubation of adult patients. Switching the device following a failed first tracheal intubation attempt was more successful than a second attempt with the same device.",2019,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","['prehospital emergency tracheal intubation of adult patients', 'Oesterreichischer Automobil- und Touring Club (OEAMTC', 'Five-hundred fourteen adult emergency patients (≥ 18 yr old', 'Prehospital Emergency Intubation in Air Rescue Patients']","['McGrath Mac Video Laryngoscope and Direct Laryngoscopy', 'McGrath Mac Video Laryngoscope and direct laryngoscopy']","['tracheal intubation times, number of attempts or difficulty', 'success rate', 'number of attempts to successful tracheal intubation, time to glottis passage and first end-tidal CO2 measurement, degree of glottis visualization, and number of problems', 'number of technical problems', 'rate of successful tracheal intubation; equivalence range']","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C3267130', 'cui_str': 'End-tidal CO2'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",514.0,0.185522,"The success rate for the two devices was equivalent: direct laryngoscopy 98.5% (254/258), McGrath Mac Video Laryngoscope 98.1% (251/256) (difference, 0.4%; 99% CI, -2.58 to 3.39).","[{'ForeName': 'Janett', 'Initials': 'J', 'LastName': 'Kreutziger', 'Affiliation': 'Department of General and Surgical Critical Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Hornung', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Harrer', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Urschl', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Doppler', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Voelckel', 'Affiliation': 'OEAMTC Air Rescue, Vienna, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Trimmel', 'Affiliation': 'Department of Anesthesiology, Emergency and Critical Care Medicine, Wiener Neustadt General Hospital, Wiener Neustadt, Austria.'}]",Critical care medicine,['10.1097/CCM.0000000000003918']
667,31407311,"Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS).","BACKGROUND


Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)-4 and IL-13] is approved for patients aged ≥ 12 years with inadequately controlled, moderate-to-severe atopic dermatitis (AD). Dupilumab trials of up to 52 weeks demonstrated efficacy and a favourable safety profile in patients with moderate-to-severe AD inadequately controlled with topical medications.
OBJECTIVES


To further characterize the safety of dupilumab by evaluating clinical laboratory findings from three randomized, double-blinded, placebo-controlled phase III trials (LIBERTY AD SOLO 1 & 2 and LIBERTY AD CHRONOS).
METHODS


Patients were randomized 1 : 1 : 1 (SOLO 1 & 2) or 3 : 1 : 3 (CHRONOS) for 16 and 52 weeks, respectively, to dupilumab weekly, every 2 weeks or placebo. CHRONOS patients received a standardized concomitant topical corticosteroid regimen. Laboratory outcomes were summarized descriptively in 1376 patients from SOLO 1 & 2 and 740 from CHRONOS.
RESULTS


Treatment groups had similar results in baseline laboratory parameters. Platelets and neutrophils showed mild decreases from baseline in dupilumab vs. placebo groups. Some dupilumab-treated patients had small transient increases in eosinophils. Grade 3 eosinophilia was reported in < 1% of dupilumab-treated and placebo-treated patients; no adverse events were associated with eosinophilia. Lactate dehydrogenase levels decreased from baseline during dupilumab treatment in all trials. No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters.
CONCLUSIONS


There were no clinically important changes in routine laboratory parameters that could be attributed to dupilumab. This study supports the use of dupilumab as a systemic treatment for moderate-to-severe AD that does not require laboratory monitoring. What's already known about this topic? Long-term treatment of atopic dermatitis (AD) with conventional immunosuppressive agents is limited by the risk of significant side-effects and a need for repeated tests to monitor haematological and/or organ (e.g. liver, kidney) toxicities. Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)-4 and IL-13] is approved for the treatment of patients with inadequately controlled, moderate-to-severe AD. In 16-week and 52-week studies, dupilumab demonstrated a positive risk/benefit profile in moderate-to-severe AD. What does this study add? This study is the first comprehensive analysis of dupilumab laboratory safety data of the 16-week SOLO 1 & 2 (pooled N = 1376) and 52-week CHRONOS (N = 740) trials, demonstrating an absence of clinically important changes in haematology, serum chemistry and urinalysis parameters in patients with moderate-to-severe AD treated with dupilumab. Our data support the use of dupilumab as a systemic treatment for the long-term management of moderate-to-severe AD without routine laboratory monitoring in clinical practice.",2020,"No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters.
","['Patients', 'moderate-to-severe atopic dermatitis', '1376 patients from SOLO 1 & 2 and 740 from CHRONOS', 'moderate-to-severe AD', 'patients aged ≥12 years with inadequately controlled, moderate-to-severe atopic dermatitis (AD', 'patients with moderate-to-severe AD inadequately controlled with topical medications']","['placebo', 'dupilumab']","['Grade 3 eosinophilia', 'eosinophils', 'adverse events', 'Lactate dehydrogenase levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}]",1376.0,0.342166,"No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximilian University of Munich, Frauenlobstraße 9-11, 80337, Munich, Germany.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rizova', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18434']
668,21257977,Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy.,"OBJECTIVE


To assess whether stress management (SM) improved immune outcomes in men undergoing surgery for prostate cancer.
METHODS


A total of 159 men were assigned randomly to a two-session presurgical SM intervention, a two-session supportive attention (SA) group, or a standard care (SC) group. Men in the SM group discussed their concerns about the upcoming surgery and were taught diaphragmatic breathing, guided imagery; they had an imaginal exposure to the day of surgery and learned adaptive coping skills. Men in the SA group discussed their concerns about the upcoming surgery and had a semistructured medical interview. Blood samples were collected at baseline (1 month before surgery) and 48 hours after surgery. Measures of mood (Profile of Mood States) were collected at baseline, 1 week pre surgery, and the morning of surgery.
RESULTS


Men in the SM group had significantly higher levels of natural killer cell cytotoxicity (p = .04) and higher levels of circulating proinflammatory cytokines (interleukin [IL]-12p70, p = .02; IL-1β, p = .02; tumor necrosis factor-α, p = .05) 48 hours post surgery than men in the SA group and higher levels of natural killer cell cytotoxicity (p = 0.02) and IL-1β (p = .05) than men in the SC group. Immune parameters increased for the SM group and decreased or stayed the same for the SA and SC groups. The SM group had significantly lower Profile of Mood States scores than the SC group (p = .006), with no other group differences between SA and SC groups. Changes in mood were not associated with immune outcomes.
CONCLUSIONS


The finding that SM leads to decreased presurgical mood-disturbance and increased immune parameters after surgery reveals the potential psychological and biological benefits of presurgical SM.",2011,"Men in the SM group had significantly higher levels of natural killer cell cytotoxicity (p = .04) and higher levels of circulating proinflammatory cytokines (interleukin [IL]-12p70,","['men with prostate cancer undergoing radical prostatectomy', 'men undergoing surgery for prostate cancer', 'A total of 159 men']","['Presurgical stress management', 'session presurgical SM intervention, a two-session supportive attention (SA) group, or a standard care (SC', 'stress management (SM']","['Measures of mood (Profile of Mood States', 'IL-1β', 'Blood samples', 'postoperative immune function', 'Mood States scores', 'circulating proinflammatory cytokines (interleukin [IL]-12p70', 'levels of natural killer cell cytotoxicity', 'Immune parameters', 'natural killer cell cytotoxicity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",159.0,0.0361861,"Men in the SM group had significantly higher levels of natural killer cell cytotoxicity (p = .04) and higher levels of circulating proinflammatory cytokines (interleukin [IL]-12p70,","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Behavioral Science-Unit 1330, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA. lcohen@mdanderson.org'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vence', 'Affiliation': ''}, {'ForeName': 'Cheryln', 'Initials': 'C', 'LastName': 'Savary', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Kentor', 'Affiliation': ''}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Pettaway', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Babaian', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Pisters', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Miles', 'Affiliation': ''}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wiltz', 'Affiliation': ''}, {'ForeName': 'Tejal', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Radvanyi', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0b013e31820a1c26']
669,30628860,Home-Based Telemedicine for Children with Medical Complexity.,"Background:  Children with medical complexity (CMC) are high utilizers of health care services. Telehealth encounters may provide a means to improve care outcomes for this population.   Objective:  To evaluate the feasibility, usability, and impact of an in-home telehealth device in the care of CMC.   Methods:  This single-center feasibility study employed a nonblinded randomized clinical trial design. English-speaking caregivers of children within a pediatric complex care program with home Wi-Fi were eligible for participation. Participants were randomized 1.5:1 with stratification based on tracheostomy status to a control group that received usual care or an intervention group that received a telehealth device for in-home use. Patients were followed up for 4 months. The primary outcome was successful device connectivity and data transmission. Data included clinician encounter device usability; caregiver satisfaction; and encounter type, purpose, and cost. Descriptive statistics, negative binomial regression, and Kaplan-Meier plot were used for analysis.   Results:  Twenty-four patients were enrolled (9 controls, 15 in the intervention group) in September 2016. The telehealth device was attempted in 73 encounters. Device connectivity was successful 96% of the time. Image and sound quality were acceptable in 98% of visits. Caregivers expressed their overall satisfaction with the device. The hospitalization rate was lower in the intervention group (0.77 vs. 1.14 intensive care unit days/patient-months), resulting in $9,425/USD per patient savings compared with the control group.   Conclusion:  Despite small sample size and short observation period, this study demonstrated that use of an in-home telehealth device is feasible, well received by caregivers, and can result in decreased hospitalizations when compared with usual care.",2019,"The hospitalization rate was lower in the intervention group (0.77 vs. 1.14 intensive care unit days/patient-months), resulting in $9,425/USD per patient savings compared with the control group.
","['Twenty-four patients were enrolled (9 controls, 15 in the intervention group) in September 2016', 'English-speaking caregivers of children within a pediatric complex care program with home Wi-Fi were eligible for participation', 'Children with medical complexity (CMC', 'Children with Medical Complexity']","['Home-Based Telemedicine', 'control group that received usual care or an intervention group that received a telehealth device for in-home use']","['successful device connectivity and data transmission', 'clinician encounter device usability; caregiver satisfaction; and encounter type, purpose, and cost', 'Image and sound quality', 'hospitalization rate', 'Device connectivity']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",24.0,0.0909561,"The hospitalization rate was lower in the intervention group (0.77 vs. 1.14 intensive care unit days/patient-months), resulting in $9,425/USD per patient savings compared with the control group.
","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Notario', 'Affiliation': 'Billings Clinic, Billings, Montana.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gentile', 'Affiliation': ""Advocate Children's Hospital, Oak Lawn, Illinois.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Amidon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Angst', 'Affiliation': 'Advocate Health Care, Downers Grove, Illinois.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lefaiver', 'Affiliation': ""Advocate Children's Hospital, Oak Lawn, Illinois.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': ""Advocate Children's Hospital, Oak Lawn, Illinois.""}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0186']
670,30891688,Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.,"BACKGROUND


Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations.
OBJECTIVES


To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention.
DESIGN


This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention.
PARTICIPANTS


Participants were community health center patients with body mass indexes of 30-44.9 kg/m 2 .
INTERVENTIONS


The weight loss intervention included tailored behavioral goal setting; weekly goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling.
MAIN MEASURES


At 6 and 12 months, participants' weight was measured and they reported if their provider delivered weight counseling (general or intervention-specific) at their most recent visit and their perception of providers' empathy. Providers' documentation of weight counseling was extracted from health records.
KEY RESULTS


Participants (n = 134-141) were predominantly female (70%) and African American (55%) with a mean age of 51 years and BMI of 36 kg/m 2 . Participant-reported provider weight counseling was not associated with weight change. However, participants whose providers documented intervention-specific counseling at any point during the intervention (n = 35) lost 3.1 kg (95% CI 0.4 to 5.7 kg) more than those whose providers documented only general weight counseling (n = 82) and 4.0 kg (95% CI 0.1 to 7.9 kg) more than those whose providers did not document weight counseling (n = 17). Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
CONCLUSIONS


Provider counseling that focuses specifically on engagement in a weight loss intervention may enhance weight loss outcomes relative to more general weight loss advice. Counseling that enhances patients' perceptions of empathy may be most beneficial for patients' weight loss.
TRIAL REGISTRATION


NCT01827800.",2019,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","['134-141) were predominantly female (70%) and African American (55%) with a mean age of 51\xa0years and BMI of 36\xa0kg/m 2 ', 'Participants (n\u2009', 'Participants were community health center patients with body mass indexes of 30-44.9\xa0kg/m 2 ']",['goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling'],"['general weight counseling', 'weight loss']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",141.0,0.0414384,"Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA. Megan.mcvay@ufl.edu.'}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Steinberg', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Askew', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Duke Global Digital Health Science Center, Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04944-5']
671,31589087,Treatment Effects in Social Cognition and Behavior following a Theater-based Intervention for Youth with Autism.,"This randomized clinical trial ( www.clinicaltrials.gov ID# NCT02276534) examined the impact of a peer-mediated, theater-based social skills intervention, SENSE Theater®, on social cognition and behavior in 77 youth (ages 8-16) with high-functioning autism spectrum disorder. Analysis of Covariance models revealed that post-treatment, the experimental group (n = 44) performed significantly better than the controls (n = 33) on NEPSY theory of mind (verbal) subtest, demonstrated increased neural evidence of memory for faces, and engaged in more cooperative play and verbal interaction with novel peers. The study extends previous findings showing that SENSE Theater® contributes to improvement in social cognition and behavior.",2019,"Analysis of Covariance models revealed that post-treatment, the experimental group (n = 44) performed significantly better than the controls (n = 33) on NEPSY theory of mind (verbal) subtest, demonstrated increased neural evidence of memory for faces, and engaged in more cooperative play and verbal interaction with novel peers.","['Youth with Autism', '77 youth (ages 8-16) with high-functioning autism spectrum disorder']","['peer-mediated, theater-based social skills intervention, SENSE Theater®']","['Social Cognition and Behavior', 'social cognition and behavior', 'neural evidence of memory for faces, and engaged in more cooperative play and verbal interaction']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",77.0,0.0261455,"Analysis of Covariance models revealed that post-treatment, the experimental group (n = 44) performed significantly better than the controls (n = 33) on NEPSY theory of mind (verbal) subtest, demonstrated increased neural evidence of memory for faces, and engaged in more cooperative play and verbal interaction with novel peers.","[{'ForeName': 'Blythe A', 'Initials': 'BA', 'LastName': 'Corbett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ioannou', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Key', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Coke', 'Affiliation': 'University School of Nashville, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Muscatello', 'Affiliation': 'Vanderbilt Brain Institute, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Vandekar', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Muse', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center , Nashville , Tennessee , USA.'}]",Developmental neuropsychology,['10.1080/87565641.2019.1676244']
672,31017470,Pentraxin-3 vs C-reactive protein and other prognostic biomarkers in acute coronary syndrome: A substudy of the Platelet Inhibition and Patients Outcomes (PLATO) trial.,"AIMS


We investigated the dynamics, associations with patient characteristics, other biomarkers, and clinical outcomes of pentraxin 3 in acute coronary syndrome.
METHODS AND RESULTS


In multivariate analyses, pentraxin 3 measured in 5154 patients randomised in the Platelet Inhibition and Patients Outcomes (PLATO) trial (NCT00391872) was compared with leukocytes, high-sensitivity C-reactive protein, interleukin-6, cystatin C, N-terminal prohormone brain natriuretic peptide, high-sensitivity troponin T and growth differentiation factor 15 concerning prediction of clinical outcome. Pentraxin 3 peaked earlier than high-sensitivity C-reactive protein and was more strongly correlated with N-terminal prohormone brain natriuretic peptide and high-sensitivity troponin T than with high-sensitivity C-reactive protein. The frequency of cardiovascular death, spontaneous myocardial infarction or stroke by quartiles of pentraxin 3 at admission was 6.1%, 7.3%, 9.7% and 10.7%, respectively ( p <0.0001). The hazard ratio per 50% increase of pentraxin 3 was 1.13 (95% confidence interval: 1.07-1.19),  p <0.0001. This association remained significant after stepwise adjustments for leukocytes/high-sensitivity C-reactive protein (1.09 (1.02-1.15)),  p =0.009, interleukin-6 (1.07 (1.01-1.14)),  p =0.026, and cystatin C (1.07 (1.00-1.13)),  p =0.044, but not after adjustment for N-terminal prohormone brain natriuretic peptide, high-sensitivity troponin T and growth differentiation factor 15. Admission pentraxin 3 was also associated with several of the individual endpoint components (cardiovascular death/spontaneous myocardial infarction;  p =0.008, cardiovascular death;  p =0.026, and spontaneous myocardial infarction;  p =0.017), but not with stroke. Pentraxin 3 measured in the chronic phase (i.e. at one month) was still predictive of the composite endpoint in univariate analysis (1.12 (1.04-1.20) per 50% increase)  p =0.0024, but not after adjustment for the other biomarkers.
CONCLUSION


Admission level of pentraxin 3 is a modestly stronger predictor than high-sensitivity C-reactive protein and interleukin-6, but not than N-terminal prohormone brain natriuretic peptide or high-sensitivity troponin T, concerning cardiovascular outcome in acute coronary syndrome. Pentraxin 3 is more strongly correlated with N-terminal prohormone brain natriuretic peptide and high-sensitivity troponin T than with high-sensitivity C-reactive protein.",2020,"The frequency of cardiovascular death, spontaneous myocardial infarction or stroke by quartiles of pentraxin 3 at admission was 6.1%, 7.3%, 9.7% and 10.7%, respectively ( p<0.0001).","['5154 patients', 'acute coronary syndrome']",['Pentraxin-3 vs C-reactive protein'],"['frequency of cardiovascular death, spontaneous myocardial infarction or stroke by quartiles of pentraxin 3 at admission', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0174234', 'cui_str': 'TNF-stimulated gene 14'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0174234', 'cui_str': 'TNF-stimulated gene 14'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",5154.0,0.200181,"The frequency of cardiovascular death, spontaneous myocardial infarction or stroke by quartiles of pentraxin 3 at admission was 6.1%, 7.3%, 9.7% and 10.7%, respectively ( p<0.0001).","[{'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Kontny', 'Affiliation': 'Department of Cardiology, Stavanger University Hospital, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Andersen', 'Affiliation': 'Department of Anaesthesiology, Stavanger University Hospital, Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology Uppsala University, Sweden.'}, {'ForeName': 'Tatevik G', 'Initials': 'TG', 'LastName': 'Lakic', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Annika E', 'Initials': 'AE', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bertilsson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease, Academic Health Center, Cincinnati, OH, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology Uppsala University, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Department of Medical Sciences, Cardiology Uppsala University, Sweden.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology Uppsala University, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Acute cardiovascular care,['10.1177/2048872619846334']
673,31730474,The feasibility of web surveys for obtaining patient-reported outcomes from cancer survivors: a randomized experiment comparing survey modes and brochure enclosures.,"BACKGROUND


Central cancer registries are often used to survey population-based samples of cancer survivors. These surveys are typically administered via paper or telephone. In most populations, web surveys obtain much lower response rates than paper surveys. This study assessed the feasibility of web surveys for collecting patient-reported outcomes via a central cancer registry.
METHODS


Potential participants were sampled from Utah Cancer Registry records. Sample members were randomly assigned to receive a web or paper survey, and then randomized to either receive or not receive an informative brochure describing the cancer registry. We calculated adjusted risk ratios with 95% confidence intervals to compare response likelihood and the demographic profile of respondents across study arms.
RESULTS


The web survey response rate (43.2%) was lower than the paper survey (50.4%), but this difference was not statistically significant (adjusted risk ratio = 0.88, 95% confidence interval = 0.72, 1.07). The brochure also did not significantly influence the proportion responding (adjusted risk ratio = 1.03, 95% confidence interval = 0.85, 1.25). There were few differences in the demographic profiles of respondents across the survey modes. Older age increased likelihood of response to a paper questionnaire but not a web questionnaire.
CONCLUSIONS


Web surveys of cancer survivors are feasible without significantly influencing response rates, but providing a paper response option may be advisable particularly when surveying older individuals. Further examination of the varying effects of brochure enclosures across different survey modes is warranted.",2019,"The web survey response rate (43.2%) was lower than the paper survey (50.4%), but this difference was not statistically significant (adjusted risk ratio = 0.88, 95% confidence interval = 0.72, 1.07).","['Potential participants were sampled from Utah Cancer Registry records', 'Sample members', 'surveying older individuals', 'cancer survivors']",['receive or not receive an informative brochure describing the cancer registry'],['survey response rate'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.193778,"The web survey response rate (43.2%) was lower than the paper survey (50.4%), but this difference was not statistically significant (adjusted risk ratio = 0.88, 95% confidence interval = 0.72, 1.07).","[{'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Millar', 'Affiliation': 'Department of Internal Medicine, 295 Chipeta Way University of Utah, Salt Lake City, UT, 84132, USA. morgan.millar@hsc.utah.edu.'}, {'ForeName': 'Joanne W', 'Initials': 'JW', 'LastName': 'Elena', 'Affiliation': 'Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD, 20852, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gallicchio', 'Affiliation': 'Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD, 20852, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Edwards', 'Affiliation': 'Utah Cancer Registry, University of Utah, 250 E 200 S, Suite 1375, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Marjorie E', 'Initials': 'ME', 'LastName': 'Carter', 'Affiliation': 'Utah Cancer Registry, University of Utah, 250 E 200 S, Suite 1375, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Herget', 'Affiliation': 'Utah Cancer Registry, University of Utah, 250 E 200 S, Suite 1375, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Department of Internal Medicine, 295 Chipeta Way University of Utah, Salt Lake City, UT, 84132, USA.'}]",BMC medical research methodology,['10.1186/s12874-019-0859-9']
674,29910047,Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial.,"The Fontan operation creates a circulation characterized by elevated central venous pressure and low cardiac output. Over time, these characteristics result in a predictable and persistent decline in exercise performance that is associated with an increase in morbidity and mortality. A medical therapy that targets the abnormalities of the Fontan circulation might, therefore, be associated with improved outcomes. Udenafil, a phosphodiesterase type 5 inhibitor, has undergone phase I/II testing in adolescents who have had the Fontan operation and has been shown to be safe and well tolerated in the short term. However, there are no data regarding the long-term efficacy of udenafil in this population. The Fontan Udenafil Exercise Longitudinal (FUEL) Trial is a randomized, double-blind, placebo-controlled phase III clinical trial being conducted by the Pediatric Heart Network in collaboration with Mezzion Pharma Co, Ltd. This trial is designed to test the hypothesis that treatment with udenafil will lead to an improvement in exercise capacity in adolescents who have undergone the Fontan operation. A safety extension trial, the FUEL Open-Label Extension Trial (FUEL OLE), offers the opportunity for all FUEL subjects to obtain open-label udenafil for an additional 12 months following completion of FUEL, and evaluates the long-term safety and tolerability of this medication. This manuscript describes the rationale and study design for FUEL and FUEL OLE. Together, these trials provide an opportunity to better understand the role of medical management in the care of those who have undergone the Fontan operation.",2018,"A safety extension trial, the FUEL Open-Label Extension Trial (FUEL OLE), offers the opportunity for all FUEL subjects to obtain open-label udenafil for an additional 12 months following completion of FUEL, and evaluates the long-term safety and tolerability of this medication.","['Pediatric Heart Network in collaboration with Mezzion Pharma Co, Ltd', 'adolescents who have undergone the Fontan operation']",['placebo'],"['exercise capacity', 'morbidity and mortality', 'Fontan Udenafil Exercise Longitudinal (FUEL']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0190010', 'cui_str': 'Norwood Procedure, Stage III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1742789', 'cui_str': '3-(1-Methyl-7-oxo-3-propyl-4,7-dihydro-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-N-(2-(1-methyl-2-pyrrolidinyl)ethyl)-4-propoxybenzenesulfonamide'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}]",,0.11167,"A safety extension trial, the FUEL Open-Label Extension Trial (FUEL OLE), offers the opportunity for all FUEL subjects to obtain open-label udenafil for an additional 12 months following completion of FUEL, and evaluates the long-term safety and tolerability of this medication.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA 19104. Electronic address: goldbergda@email.chop.edu.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zak', 'Affiliation': 'New England Research Institutes, Watertown, MA 02472.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'Goldstein', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario M5G 1X8.'}, {'ForeName': 'Shaji C', 'Initials': 'SC', 'LastName': 'Menon', 'Affiliation': 'Division of Pediatric Cardiology, University of Utah, Salt Lake City, UT 84132.'}, {'ForeName': 'Kurt R', 'Initials': 'KR', 'LastName': 'Schumacher', 'Affiliation': ""Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI 48109.""}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Payne', 'Affiliation': 'Division of Cardiology, Riley Hospital for Children, Indianapolis, IN 46202.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': ""Department of Cardiology, Children's Hospital Boston, Boston, MA 02115.""}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'McHugh', 'Affiliation': 'Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC 29425.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Penny', 'Affiliation': ""Division of Cardiology, Texas Children's Hospital, Houston, TX 77030.""}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, MA 02472.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229.""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': ""Division of Pediatric Cardiology, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY 10032.""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Frommelt', 'Affiliation': ""Division of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, WI 53226.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Files', 'Affiliation': ""Division of Cardiology, Seattle Children's Hospital, Seattle, WA 98105.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Yeager', 'Affiliation': 'Consultant to Mezzion Pharma Co. Ltd., Mezzion Pharma Co. Ltd., Seoul, South Korea 135-879.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD 20892.'}, {'ForeName': 'Mario P', 'Initials': 'MP', 'LastName': 'Stylianou', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD 20892.'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Pearson', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD 20892.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Paridon', 'Affiliation': ""Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA 19104.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2018.03.015']
675,30649270,Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: a sub-study of the international randomized MINERVA trial.,"AIMS


Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients.
METHODS AND RESULTS


In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: the risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP.
CONCLUSION


Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing.",2019,The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence:,"['dual chamber pacemaker patients', '906 patients with available data', '1166 patients were randomized to']","['Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP', 'PR interval and pacing mode']","['PR interval', 'Persistent AF incidence', 'lower [hazard ratio (HR', 'persistent atrial fibrillation incidence', 'median PR interval']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0520877', 'cui_str': 'PR interval feature'}]","[{'cui': 'C0520877', 'cui_str': 'PR interval feature'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1166.0,0.021812,The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence:,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena University Hospital, via Giuseppe Campi, 287, Modena, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pieragnoli', 'Affiliation': 'Institute of Internal Medicine and Cardiology, University Hospital of Florence, Florence, Italy.'}, {'ForeName': 'Giovanni Luca', 'Initials': 'GL', 'LastName': 'Botto', 'Affiliation': 'Cardiac Electrophysiology, ASST Rhodense, Rho AND Garbagnate Hospitals, Milan, Italy.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Puererfellner', 'Affiliation': 'Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Department of Cardiology, Hospital Clinic, University of Barcelona, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ziacchi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S.Orsola-Malpighi University Hospital, Bologna, Italy.'}, {'ForeName': 'Antonis S', 'Initials': 'AS', 'LastName': 'Manolis', 'Affiliation': 'Third Department of Cardiology, Athens University School of Medicine, Athens, Greece.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Gulizia', 'Affiliation': 'Cardiology Department, Garibaldi Nesima Hospital, Catania, Italy.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tukkie', 'Affiliation': 'Department of Cardiology, Kennemer Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Landolina', 'Affiliation': 'Institute of Cardiology, Maggiore Hospital, Crema, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ricciardi', 'Affiliation': 'Institute of Internal Medicine and Cardiology, University Hospital of Florence, Florence, Italy.'}, {'ForeName': 'Manuele', 'Initials': 'M', 'LastName': 'Cicconelli', 'Affiliation': 'Study & Scientific Solutions, Medtronic Core Clinical Solutions, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Grammatico', 'Affiliation': 'Study & Scientific Solutions, Medtronic Core Clinical Solutions, Rome, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Biffi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S.Orsola-Malpighi University Hospital, Bologna, Italy.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy286']
676,31715582,Individualized Training Based on Force-Velocity Profiling During Jumping in Ballet Dancers.,"PURPOSE


Ballet dancers are required to achieve performance feats such as exciting and dramatic elevations. Dancers with a greater jump height can perform a wider range of skills during their flight time and implement more specific technical skills related to the aesthetic components of a dance choreography. New findings suggest the relationship between force and velocity mechanical capabilities (F-V profile) as an important variable for jumping performance. A new field method based on several series of loaded vertical jumps provides information on the theoretical maximal force, theoretical maximal velocity, theoretical maximal power, and the imbalance between force and velocity (F-VIMB). The purpose of this study was to observe the effects of 9 wk of individualized F-V profile-based training during countermovement jumps (CMJs) in female ballet dancers.
METHODS


CMJ and mechanical outputs of 46 dancers (age = 18.9 [1.1] y, body mass = 54.8 [6.1] kg, height = 163.7 [8.4] cm) were estimated in a pre-post intervention. The control group (10 participants) continued with the standardized training regimen (no resistance training), whereas the experimental group (36 participants) performed 2 sessions over 9 wk of a training plan based on their F-V profile.
RESULTS


The experimental group presented significant differences with large effect sizes in CMJ height (29.3 [3.2] cm vs 33.5 [3.72] cm), theoretical maximal force (24.1 [2.2] N/kg vs 29.9 [2.8] N/kg), and theoretical maximal velocity (4 [0.6] m/s vs 3.2 [0.5] m/s). Significant differences with a very large effect size were found in F-VIMB (43.8% [15.3%] vs 24.9% [8.7%]).
CONCLUSION


A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.",2020,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"['female ballet dancers', '46 dancers (age ']","['individualized F-V profile-based training during countermovement jumps (CMJs', 'standardized training regimen (no resistance training', 'Individualized Training Based on Force-Velocity Profiling']","['theoretical maximal force', 'F-VIMB', 'CMJ height']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",36.0,0.0246706,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"[{'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Escobar Álvarez', 'Affiliation': ''}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Fuentes García', 'Affiliation': ''}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Da Conceição', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0492']
677,26413083,Preliminary assessment of Hedychium coronarium essential oil on fibrinogenolytic and coagulant activity induced by Bothrops and Lachesis snake venoms.,"BACKGROUND


The search for new inhibitors of snake venom toxins is essential to complement or even replace traditional antivenom therapy, especially in relation to compounds that neutralize the local effects of envenomations. Besides their possible use as alternative to traditional antivenom therapy, some plant species possess bioactive secondary metabolites including essential oils, which can be extracted from weeds that are considered substantial problems for agriculture, such as Hedychium coronarium.
METHODS


The essential oils of leaves and rhizomes from H. coronarium were extracted by hydrodistillation, and their potential inhibitory effects on the coagulant and fibrinogenolytic activities induced by the venoms of Lachesis muta, Bothrops atrox and Bothrops moojeni were analyzed. Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel. The experimental design used for testing coagulation inhibition was randomized in a 3 × 2 factorial arrangement (concentration × essential oils), with three replications. The essential oils were compared since they were extracted from different organs of the same botanical species, H. coronarium.
RESULTS


The results suggest that the oils interact with venom proteases and plasma constituents, since all oils evaluated, when previously incubated with venoms, were able to inhibit the clotting effect, with less inhibition when oils and plasma were preincubated prior to the addition of venoms.
CONCLUSIONS


Thus, after extensive characterization of their pharmacological and toxicological effects, the essential oils can be used as an alternative to complement serum therapy, especially considering that these plant metabolites generally do not require specific formulations and may be used topically immediately after extraction.",2014,Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel.,[],['Hedychium coronarium essential oil'],"['fibrinogenolytic and coagulant activity', 'clotting time']",[],"[{'cui': 'C1080914', 'cui_str': 'Hedychium'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}]","[{'cui': 'C0009117', 'cui_str': 'Coagulants'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0195095,Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel.,"[{'ForeName': 'Cíntia A Sf', 'Initials': 'CA', 'LastName': 'Miranda', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Cardoso', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil ; Laboratório de Química Orgânica, Departamento de Química, Universidade Federal de Lavras, Caixa postal 3037, CEP 37200-000 Lavras, MG, Brasil.'}, {'ForeName': 'Mariana E', 'Initials': 'ME', 'LastName': 'Mansanares', 'Affiliation': 'Department of Biology, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Marcos S', 'Initials': 'MS', 'LastName': 'Gomes', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Marcussi', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}]",The journal of venomous animals and toxins including tropical diseases,['10.1186/1678-9199-20-39']
678,30990088,Parent-Teen Group versus Dyadic Treatment for Adolescent ADHD: What Works for Whom?,"The goal of this study was to evaluate the comparative efficacy of 2 clinic-based psychosocial treatment modalities for adolescent attention deficit/hyperactivity disorder (ADHD) and identify characteristics that facilitate patient-modality matching. Culturally diverse adolescents with ADHD ( N =  123) were randomized to 1 of 2 versions of a parent-teen psychosocial treatment for ADHD (Supporting Teens' Autonomy Daily [STAND]): (a) group parent and adolescent skills training or (b) dyadic skills training blended with motivational interviewing. Participants were assessed at baseline, posttreatment, and 6-month follow-up on ADHD symptom severity and functional treatment targets. Differences in therapy process and cost were documented. Modality differences in outcome were examined using linear mixed and general linear models. Each modality successfully engaged the proposed therapy processes. Dyadic and group STAND produced equivalent overall outcomes. However, the dyadic modality demonstrated superior efficacy when parents had elevated ADHD or depression symptoms or high conflict with the teen. Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group). Naturalistic stimulant medication did not influence treatment outcome. At less than one third of the cost of dyadic treatment, group models may be an economical option for treating parents and adolescents with ADHD. Screening adolescents with ADHD for parental psychopathology and parent-teen conflict may allow clinics to match higher risk patients to more personalized approaches that can enhance efficacy.",2020,Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group).,"['N =\xa0123', 'Culturally diverse adolescents with ADHD', 'parents and adolescents with ADHD', 'Screening adolescents with ADHD', 'adolescent attention deficit/hyperactivity disorder (ADHD', 'Adolescent ADHD']","['2 clinic-based psychosocial treatment modalities', ""parent-teen psychosocial treatment for ADHD (Supporting Teens' Autonomy Daily [STAND"", 'adolescent skills training or (b) dyadic skills training blended with motivational interviewing']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]",[],123.0,0.0355367,Families with lower parent education level and higher parental depression showed lower overall attendance; married parents were more likely to attend dyadic STAND (vs. group).,"[{'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Florida International University.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Children and Families, Florida International University.'}, {'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Coxe', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Health Policy and Management, Florida International University.'}, {'ForeName': 'Kisbel', 'Initials': 'K', 'LastName': 'Espinal', 'Affiliation': 'Center for Children and Families, Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1585257']
679,30982687,"Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial.","BACKGROUND


The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.
METHODS


This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0-1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1-3 vs 4-5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744.
FINDINGS


99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19-54) in the control group versus 26 months (23-37) in the SABR group. Median overall survival was 28 months (95% CI 19-33) in the control group versus 41 months (26-not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30-1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5-34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
INTERPRETATION


SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit.
FUNDING


Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.",2019,"Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
","['patients with a controlled primary tumour and one to five oligometastatic lesions', 'Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0-1, and a life expectancy of at least 6 months were eligible', '99 patients were randomised between Feb 10, 2012, and Aug 30, 2016', 'patients with oligometastatic cancers (SABR-COMET', '10 hospitals in Canada, the Netherlands, Scotland, and Australia']","['palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group', 'stereotactic ablative radiotherapy (SABR', 'Stereotactic ablative radiotherapy versus standard of care palliative treatment']","['treatment-related death', 'survival, oncological outcomes, toxicity, and quality of life', 'deaths', 'Median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",99.0,0.291708,"Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada. Electronic address: david.palma@lhsc.on.ca.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': 'British Columbia Cancer, Centre for the North, Prince George, BC, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrow', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Gaede', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Haasbeek', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Mulroy', 'Affiliation': 'Nova Scotia Cancer Centre, Halifax, NS, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Schellenberg', 'Affiliation': 'British Columbia Cancer, Surrey Centre, Surrey, BC, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Griffioen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Sashendra', 'Initials': 'S', 'LastName': 'Senthi', 'Affiliation': 'Alfred Health Radiation Oncology, Melbourne, VIC, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaminath', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, ON, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Kopek', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'British Columbia Cancer, Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Currie', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)32487-5']
680,30955400,The Effect of Soybean Lunasin on Cardiometabolic Risk Factors: A Randomized Clinical Trial.,"Lunasin, a peptide isolated from soybeans, has been shown to exert antioxidant, anticarcinogenic, and hypocholesterolemic effects in animal and in vitro models. In a triple-blind, placebo-controlled crossover study, 31 participants (female: 19, male: 12, mean age 61 ± 9.9 years) were randomized to an 8-week treatment of lunasin-enriched soy extract (335mg/d) or placebo. A 3-week washout period was utilized between treatments. Serum lipids, glucose, and insulin, as well as blood pressure and anthropometrics, were measured at baseline, week 7, and week 8 of each treatment period. There were nonsignificant reductions in cardiometabolic risk factors with treatment: total cholesterol -0.1mmol/L, 95% CI [-0.28, 0.03]; LDL cholesterol -0.07mmol/L, 95% CI [-0.2, 0.06]; triglyceride 0% mmol/L, 95% CI (-10%, 11%]; fasting serum glucose -2% mmol/L, 95% CI [-4%, 1%]; BMI -0.05 kg/m2, 95% CI [-0.17, 0.07] and waist circumference -0.63cm, 95% CI [-1.8, 0.53]. Supplementation with lunasin-enriched soy extract for 8 weeks did not result in significant changes in serum lipids, glucose, insulin resistance, blood pressure, BMI, or waist circumference. Future studies should focus on a higher dosage, larger sample size, and/or longer treatment to determine the independent role of lunasin, if any, in the effect of soy on cardiometabolic risk factors.",2020,"Supplementation with lunasin-enriched soy extract for 8 weeks did not result in significant changes in serum lipids, glucose, insulin resistance, blood pressure, BMI, or waist circumference.","['31 participants (female: 19, male: 12, mean age 61 ± 9.9 years']","['lunasin-enriched soy extract (335mg/d) or placebo', 'placebo', 'Soybean Lunasin', 'lunasin-enriched soy extract']","['cardiometabolic risk factors', 'fasting serum glucose', 'serum lipids, glucose, insulin resistance, blood pressure, BMI, or waist circumference', 'Serum lipids, glucose, and insulin, as well as blood pressure and anthropometrics', 'Cardiometabolic Risk Factors']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",31.0,0.281596,"Supplementation with lunasin-enriched soy extract for 8 weeks did not result in significant changes in serum lipids, glucose, insulin resistance, blood pressure, BMI, or waist circumference.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Haddad Tabrizi', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Haddad', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Rajaram', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Oda', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Sabaté', 'Affiliation': 'Center for Nutrition, Healthy Lifestyle and Disease Prevention, School of Public Health, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1577937']
681,31808295,Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: Results from the BRAVO-3 randomized trial.,"OBJECTIVES


This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH).
BACKGROUND


PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH.
METHODS


BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE.
RESULTS


The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days.
CONCLUSIONS


Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.",2020,"No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD.","['119 patients with PAD', 'patients with or without PAD', 'Patients with PAD undergoing', 'patients undergoing transcatheter aortic valve replacement (TAVR', '31 centers, n = 802', 'patients with and without peripheral artery disease (PAD', 'patients with and without peripheral arterial disease']","['TAVR with heparin or bivalirudin', 'bivalirudin versus UFH', 'bivalirudin', 'bivalirudin versus unfractionated heparin (UFH', 'transfemoral TAVR', 'Bivalirudin']","['Vascular complications', 'rates of minor vascular complications', 'Major adverse cardiovascular events (MACE', 'mortality, NACE, MACE, major bleeding or CVA', 'risk of any major adverse events', '30-day death, myocardial infarction, or cerebrovascular accidents (CVA', 'risk of minor vascular complications', 'Net adverse cardiovascular events (NACE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",119.0,0.247024,"No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zilberszac', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schafer', 'Affiliation': 'Department of Cardiology, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Department of General and Interventional Cardiology, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Violini', 'Affiliation': 'Interventional Cardiology Unit, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Department of Cardiology and INSERM UMR 1011, University Hospital and CHRU Lille, Lille, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Department of Cardiology, Helios Heart Center Siegburg, Siegburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Department of Cardiology, Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumenteil', 'Affiliation': 'Department of General and Interventional Cardiology, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Cardiology, Universität Leipzig, Herzzentrum, Leipzig, Germany.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc., Sparta, New Jersey.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'Division of Cardiology, The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28642']
682,30376051,Impact of periprocedural anticoagulation therapy on the incidence of silent stroke after atrial fibrillation ablation in patients receiving direct oral anticoagulants: uninterrupted vs. interrupted by one dose strategy.,"AIMS


Data on the comparison between uninterrupted and interrupted by one dose strategies for direct oral anticoagulant (DOAC) use during the periprocedural period of atrial fibrillation (AF) ablation are scarce. The purpose of this study is to investigate the feasibility of uninterrupted DOAC strategy by evaluating the incidence of silent stroke (SS) and perioperative trends in coagulation markers compared with the interrupted strategy.
METHODS AND RESULTS


We randomly divided 200 consecutive patients receiving DOACs, who underwent AF ablation into uninterrupted group (UG = 100) and interrupted by one dose group (IG = 100). The rate of SS confirmed by post-operative magnetic resonance imaging and periprocedural trends in coagulation markers was investigated. A significant difference in SS incidence was found between the UG and IG (UG 4%, IG 17%, P < 0.005), although there were no differences in the rate of complications including bleeding and symptomatic thrombo-embolic events between the two groups. Intraoperative cardioversion [odds ratio (OR) 7.27, 95% confidence interval (CI) 1.76-30.0; P < 0.01] and the length of procedure time (OR 1.03, 95% CI 1.01-1.05; P < 0.05) independently predicted the occurrence of SS in the IG. A significant increase in prothrombin fragment 1 + 2 (PF1 + 2) values was observed in the IG compared with the UG on the operative and first post-operative days.
CONCLUSION


Silent stroke incidence in the IG was significantly higher than that in the UG; this seems to be supported by the difference in PF1 + 2 values between the UG and IG. Intraoperative cardioversion and procedure time predicted the occurrence of SS in the IG.",2019,"Intraoperative cardioversion [odds ratio (OR) 7.27, 95% confidence interval (CI) 1.76-30.0; P < 0.01] and the length of procedure time (OR 1.03, 95% CI 1.01-1.05; P < 0.05) independently predicted the occurrence of SS in the IG.","['patients receiving direct oral anticoagulants', '200 consecutive patients receiving DOACs, who underwent']","['periprocedural anticoagulation therapy', 'AF ablation into uninterrupted group (UG\u2009=\u2009100) and interrupted by one dose group (IG\u2009=\u2009100', 'direct oral anticoagulant (DOAC']","['silent stroke', 'length of procedure time', 'SS incidence', 'prothrombin fragment 1\u2009+\u20092 (PF1\u2009+\u20092) values', 'Silent stroke incidence', 'rate of complications including bleeding and symptomatic thrombo-embolic events', 'rate of SS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1299418', 'cui_str': 'Length of procedure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",200.0,0.0311367,"Intraoperative cardioversion [odds ratio (OR) 7.27, 95% confidence interval (CI) 1.76-30.0; P < 0.01] and the length of procedure time (OR 1.03, 95% CI 1.01-1.05; P < 0.05) independently predicted the occurrence of SS in the IG.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Syun', 'Initials': 'S', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Mamiya', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Shinoda', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Marui', 'Affiliation': 'Department of Cardiology, Chubu Rosai Hospital, 10-6 1-Chome Komei, Minato-ku, Nagoya, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Department of Cardiology, Aichi-Medical University, 1-1 Yazakokarimata, Nagakute, Japan.'}, {'ForeName': 'Yasuya', 'Initials': 'Y', 'LastName': 'Inden', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa, Nagoya, Aichi, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa, Nagoya, Aichi, Japan.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy224']
683,30649276,Comparison between linear and focal ablation of complex fractionated atrial electrograms in patients with non-paroxysmal atrial fibrillation: a prospective randomized trial.,"AIMS


Findings regarding efficacy of substrate modification for non-paroxysmal atrial fibrillation (AF) are inconsistent. We prospectively compared clinical outcomes of complex fractionated atrial electrogram (CFAE)-guided focal ablation (CFA) and CFAE-guided linear ablation (CLA) in patients with non-paroxysmal AF.
METHODS AND RESULTS


We randomized 150 patients with non-paroxysmal AF into CFA and CLA groups in a 1:1 ratio. Complex fractionated atrial electrogram distribution was evaluated using an automated algorithm of a three-dimensional mapping system. After pulmonary vein isolation (PVI), CFAE-guided ablation was performed in the left atrium and then in the right atrium (RA). When compared with conventional CFA, CLA was performed based on conventional lines, with additional lines. Atrial fibrillation was not induced after PVI alone or with cavotricuspid isthmus ablation in 20.7% of patients. To achieve the endpoint, additional CFAE-guided RA ablation was required in 42.7% and 36.0% of patients undergoing CFA and CLA, respectively (P = 0.403). Atrial fibrillation was terminated during CFAE-guided ablation in 72.9% and 75.0% of patients undergoing CFA and CLA, respectively (P = 0.792). Termination of atrial tachycardia (AT) or non-inducibility of AF/AT was achieved in 61.3% and 68.0% of patients undergoing CFA and CLA, respectively (P = 0.393). The CLA group showed decreased 1-year freedom from AF/AT recurrence (60.0%, CFA vs. 47.3%, CLA; log rank P = 0.085), but no significant difference throughout the follow-up (22.2 ± 21.0 months) (67.1%, CFA vs. 68.9%, CLA; log rank P = 0.298).
CONCLUSION


Long-term efficacy of CFAE-guided ablation was unaffected by the ablation technique in patients with non-paroxysmal AF.",2019,Long-term efficacy of CFAE-guided ablation was unaffected by the ablation technique in patients with non-paroxysmal AF.,"['non-paroxysmal atrial fibrillation (AF', 'patients with non-paroxysmal AF', '150 patients with non-paroxysmal AF into CFA and CLA groups in a 1:1 ratio', 'patients with non-paroxysmal atrial fibrillation']","['conventional CFA, CLA', 'CFAE-guided ablation', 'complex fractionated atrial electrogram (CFAE)-guided focal ablation (CFA) and CFAE-guided linear ablation (CLA', 'pulmonary vein isolation (PVI), CFAE-guided ablation', 'CLA', 'complex fractionated atrial electrograms']","['1-year freedom from AF/AT recurrence', 'Termination of atrial tachycardia (AT', 'Atrial fibrillation']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2350882', 'cui_str': 'Intra-Atrial Electrogram'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",150.0,0.0234865,Long-term efficacy of CFAE-guided ablation was unaffected by the ablation technique in patients with non-paroxysmal AF.,"[{'ForeName': 'Kwang-No', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Il', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Yun Gi', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Suk-Kyu', 'Initials': 'SK', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Dong-Hyeok', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Sejong General Hospital, 91-121 Sosabon-dong, Sosa-gu, Bucheon, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Dae In', 'Initials': 'DI', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, 776, 1 Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Seung-Young', 'Initials': 'SY', 'LastName': 'Roh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongguk University Medical Center, 814 Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, 179 Gudeok-ro, Amidong 1-ga, Seo-gu, Busan, Republic of Korea.'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Weon', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Sejong General Hospital, 91-121 Sosabon-dong, Sosa-gu, Bucheon, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Medical Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy313']
684,27751729,Genomic Biomarkers of a Randomized Trial Comparing First-line Everolimus and Sunitinib in Patients with Metastatic Renal Cell Carcinoma.,"BACKGROUND


Metastatic renal cell carcinoma (RCC) patients are commonly treated with vascular endothelial growth factor (VEGF) inhibitors or mammalian target of rapamycin inhibitors. Correlations between somatic mutations and first-line targeted therapy outcomes have not been reported on a randomized trial.
OBJECTIVE


To evaluate the relationship between tumor mutations and treatment outcomes in RECORD-3, a randomized trial comparing first-line everolimus (mTOR inhibitor) followed by sunitinib (VEGF inhibitor) at progression with the opposite sequence in 471 metastatic RCC patients.
DESIGN, SETTING, AND PARTICIPANTS


Targeted sequencing of 341 cancer genes at ∼540× coverage was performed on available tumor samples from 258 patients; 220 with clear cell histology (ccRCC).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Associations between somatic mutations and median first-line progression free survival (PFS1L) and overall survival were determined in metastatic ccRCC using Cox proportional hazards models and log-rank tests.
RESULTS AND LIMITATIONS


Prevalent mutations (≥ 10%) were VHL (75%), PBRM1 (46%), SETD2 (30%), BAP1 (19%), KDM5C (15%), and PTEN (12%). With first-line everolimus, PBRM1 and BAP1 mutations were associated with longer (median [95% confidence interval {CI}] 12.8 [8.1, 18.4] vs 5.5 [3.1, 8.4] mo) and shorter (median [95% CI] 4.9 [2.9, 8.1] vs 10.5 [7.3, 12.9] mo) PFS1L, respectively. With first-line sunitinib, KDM5C mutations were associated with longer PFS1L (median [95% CI] of 20.6 [12.4, 27.3] vs 8.3 [7.8, 11.0] mo). Molecular subgroups of metastatic ccRCC based on PBRM1, BAP1, and KDM5C mutations could have predictive values for patients treated with VEGF or mTOR inhibitors. Most tumor DNA was obtained from primary nephrectomy samples (94%), which could impact correlation statistics.
CONCLUSIONS


PBRM1, BAP1, and KDM5C mutations impact outcomes of targeted therapies in metastatic ccRCC patients.
PATIENT SUMMARY


Large-scale genomic kidney cancer studies reported novel mutations and heterogeneous features among individual tumors, which could contribute to varied clinical outcomes. We demonstrated correlations between somatic mutations and treatment outcomes in clear cell renal cell carcinoma, supporting the value of genomic classification in prospective studies.",2017,"Associations between somatic mutations and median first-line progression free survival (PFS1L) and overall survival were determined in metastatic ccRCC using Cox proportional hazards models and log-rank tests.
","['Targeted sequencing of 341 cancer genes at ∼540× coverage was performed on available tumor samples from 258 patients; 220 with clear cell histology (ccRCC', 'Patients with Metastatic Renal Cell Carcinoma', 'Metastatic renal cell carcinoma (RCC) patients', '471 metastatic RCC patients', 'metastatic ccRCC patients']","['line everolimus (mTOR inhibitor) followed by sunitinib (VEGF inhibitor', 'vascular endothelial growth factor (VEGF) inhibitors or mammalian target of rapamycin inhibitors', 'First-line Everolimus and Sunitinib']","['VHL', 'somatic mutations and median first-line progression free survival (PFS1L) and overall survival', 'PBRM1', 'BAP1']","[{'cui': 'C0919437', 'cui_str': 'Cancer Genes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0293060', 'cui_str': 'Mammalian Target of Rapamycin'}]","[{'cui': 'C0544886', 'cui_str': 'Somatic mutation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",471.0,0.0851135,"Associations between somatic mutations and median first-line progression free survival (PFS1L) and overall survival were determined in metastatic ccRCC using Cox proportional hazards models and log-rank tests.
","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Hsieh', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: hsiehj@mskcc.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Wang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Almedina', 'Initials': 'A', 'LastName': 'Redzematovic', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ying-Bei', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'S Duygu', 'Initials': 'SD', 'LastName': 'Selcuklu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Weinhold', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bouvier', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kety H', 'Initials': 'KH', 'LastName': 'Huberman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Bhanot', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Chevinsky', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA; Barnes Jewish Hospital, St. Louis, MO, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Pinciroli', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Helen H', 'Initials': 'HH', 'LastName': 'Won', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daoqi', 'Initials': 'D', 'LastName': 'You', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Viale', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'A Ari', 'Initials': 'AA', 'LastName': 'Hakimi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Berger', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Socci', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Cheng', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Center, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Voi', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",European urology,['10.1016/j.eururo.2016.10.007']
685,31545155,Torque gains and neural adaptations following low-intensity motor nerve electrical stimulation training.,"The purpose of the study was to assess neural adaptations of the plantar-flexors induced by an electrical stimulation training applied over the motor nerve at low intensity using two different stimulation frequencies. Thirty subjects were randomly assigned into 3 groups: 20 Hz, 100 Hz, and control group. The training consisted of 15 sessions of 25 stimulation trains applied over the tibial nerve and delivered at an intensity evoking 10% maximal voluntary isometric contraction (MVIC). Before and after training, MVIC was assessed and neural adaptations were evaluated by the voluntary activation level (VAL) and the V-wave (normalized by the superimposed muscle compound action potential, V/M SUP ). H-reflex and motor-evoked potential (MEP) recorded during MVIC were studied to assess spinal and corticospinal excitabilities [i.e., maximal H-reflex during maximal voluntary isometric contraction (H SUP )/M SUP  and maximal motor-evoked potential during maximal voluntary isometric contraction (MEP SUP )/M SUP ]. MVIC significantly increased after training only for the two training groups ( P  = 0.017). This increase was accompanied by a significant increase of VAL only for these groups ( P  = 0.014), whereas statistical analysis revealed a time effect for V/M SUP  ( P  = 0.022). H SUP /M SUP  and MEP SUP /M SUP  were significantly increased at post conditions only for the 100 Hz group ( P  = 0.021 and  P  = 0.029). Results show that low-intensity electrical stimulation training applied over the motor nerve can induce torque gains, accompanied by neural adaptations. Stimulation frequency differentially affected spinal and corticospinal excitabilities, indicating that neural adaptations could have a supraspinal origin for the 20-Hz protocol, whereas spinal and supraspinal mechanisms were implicated in the torque increases after the 100-Hz training. NEW & NOTEWORTHY  This study brings new insights into the neurophysiological mechanisms responsible for torque gains after electrical stimulation training using wide pulse duration and low stimulation intensity applied over the motor nerve. Stimulation frequency had a distinct impact on spinal and/or supraspinal origins of the observed neural adaptations. The use of the aforementioned stimulation parameters in rehabilitation settings can be proved beneficial in terms of strength gains while avoiding any serious discomfort because of stimulation.",2019,SUP  were significantly increased at post conditions only for the 100 Hz group (P=0.021 and P=0.029).,['Thirty subjects'],"['H SUP /M', '25 stimulation trains applied over the tibial nerve and delivered at an intensity evoking 10% Maximal Voluntary Isometric Contraction (MVIC', 'low intensity motor nerve electrical stimulation training', 'low intensity electrical stimulation training', 'electrical stimulation training']","['torque gains', 'SUP', 'VAL', 'voluntary activation level (VAL) and the V-wave', 'Torque gains and neural adaptations', 'MVIC', 'H reflex and Motor Evoked Potential (MEP', 'SUP  and MEP SUP']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1529218', 'cui_str': 'Vals'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4301968', 'cui_str': 'v wave (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}]",30.0,0.0194353,SUP  were significantly increased at post conditions only for the 100 Hz group (P=0.021 and P=0.029).,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Vitry', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papaiordanidou', 'Affiliation': 'INSERM UMR1093-CAPS, Université Bourgogne Franche-Comté, UFR des Sciences du Sport, F-21000, Dijon, France.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00513.2019']
686,30937667,Why Content and Cognition Matter: Integrating Conceptual Knowledge to Support Simulation-Based Procedural Skills Transfer.,"BACKGROUND


Curricular constraints require being selective about the type of content trainees practice in their formal training. Teaching trainees procedural knowledge about ""how"" to perform steps of a skill along with conceptual knowledge about ""why"" each step is performed can support skill retention and transfer (i.e., the ability to adapt knowledge to novel problems). However, how best to organize how and why content for procedural skills training is unknown.
OBJECTIVES


We examined the impact of different approaches to integrating why and how content on trainees' skill retention and transfer of simulation-based lumbar puncture (LP).
DESIGN AND PARTICIPANTS


We randomized medical students (N = 66) to practice LP for 1 h using one of three videos. One video presented only the how content for LP (Procedural Only). Two other videos presented how and why content (e.g., anatomy) in two ways: Integrated in Sequence, with why content followed by how content, or Integrated for Causation, with how and why content integrated throughout.
MAIN MEASURES


Pairs of blinded raters scored participants' retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge.
KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01). Further, the Integrated for Causation group performed significantly better on transfer than the Integrated in Sequence group (p < 0.01), again mediated by improved conceptual knowledge. We observed no mediation of participants' skill retention (all p > 0.01).
CONCLUSIONS


When teaching supports cognitive integration of how and why content, trainees are able to transfer learning to new problems because of their improved conceptual understanding. Instructional designs for procedural skills that integrate how and why content can help educators optimize what trainees learn from each repetition of practice.",2019,"KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).",['We randomized medical students (N\u2009=\u200966) to'],"['simulation-based lumbar puncture (LP', 'practice LP']","["" retention and transfer LP performances on a global rating scale (GRS), and written tests assessed participants' procedural and conceptual knowledge"", ""participants' skill retention"", 'conceptual knowledge']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0158405,"KEY RESULTS


Simple mediation regression analyses showed that participants receiving an integrated instructional video performed significantly better on transfer through their intervention's positive impact on conceptual knowledge (all p < 0.01).","[{'ForeName': 'Jeffrey J H', 'Initials': 'JJH', 'LastName': 'Cheung', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada. jeffreyjcheung@gmail.com.'}, {'ForeName': 'Kulamakan M', 'Initials': 'KM', 'LastName': 'Kulasegaram', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Woods', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Brydges', 'Affiliation': 'The Wilson Centre, University Health Network and University of Toronto, Toronto, Canada.'}]",Journal of general internal medicine,['10.1007/s11606-019-04959-y']
687,30908085,Gaze-Contingent Music Reward Therapy for Clinically Anxious 7- to 10-Year-Olds: An Open Multiple Baseline Feasibility Study.,"This multiple-baseline open pilot trial examined feasibility, compliance, acceptability, and preliminary indices of efficacy of Gaze-Contingent Music Reward Therapy (GC-MRT) for anxious 7- to 10-year-old children. GC-MRT is a novel therapy for anxiety disorders that relies on eye-tracking technology and operant conditioning principles to divert attention toward neutral over threat stimuli, with music serving as a reward. Using a multiple-baseline design, 12 children ( M   age  = 8.3 years,  SD  = .72, range = 7-10; 4 girls) with social anxiety disorder, generalized anxiety disorder, or separation anxiety disorder received 8 therapy sessions. Clinical status was determined via semistructured interviews and questionnaires. Patients were randomized to wait 1, 3, or 5 weeks between initial assessment and beginning of therapy. Self-reported anxiety was recorded weekly, and comprehensive clinical assessments were obtained pre- and posttreatment. All 12 patients completed the full course of GC-MRT within the allocated therapy period. Therapy credibility rates were moderate to high as reported by both children and parents. Clinician-rated anxiety levels remained consistent during baseline measurement and decreased significantly following treatment. Parent-reports also yielded significant reductions in child anxiety symptoms from pre- to posttreatment. However, child-reported anxiety did not change significantly. The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders. Efficacy should now be tested in randomized controlled trials.",2020,"The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders.","['young children with anxiety disorders', 'Clinically Anxious 7- to 10-Year-Olds', 'anxious 7- to 10-year-old children', '12 children (M age \xa0=\xa08.3\xa0years, SD\xa0=\xa0.72, range\xa0=\xa07-10; 4 girls) with social anxiety disorder, generalized anxiety disorder, or separation anxiety disorder received 8 therapy sessions']","['Gaze-Contingent Music Reward Therapy', 'GC-MRT', 'Gaze-Contingent Music Reward Therapy (GC-MRT']","['Self-reported anxiety', 'Therapy credibility rates', 'child anxiety symptoms', 'anxiety', 'Clinician-rated anxiety levels']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003477', 'cui_str': 'Separation Anxiety Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",12.0,0.0304015,"The results provide preliminary evidence for feasibility, acceptability, and efficacy of GC-MRT for young children with anxiety disorders.","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Linetzky', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kahn', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lazarov', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1573685']
688,30928162,Could Differences in Treatment Between Trial Arms Explain the Reduction in Prostate Cancer Mortality in the European Randomized Study of Screening for Prostate Cancer?,"BACKGROUND


Differential treatment between trial arms has been suggested to bias prostate cancer (PC) mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
OBJECTIVE


To quantify the contribution of treatment differences to the observed PC mortality reduction between the screening arm (SA) and the control arm (CA).
DESIGN, SETTING, AND PARTICIPANTS


A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes measurements were observed and estimated numbers of PC deaths by treatment allocation in the SA and CA, respectively. Primary treatment allocation was modeled using multinomial logistic regression adjusting for center, age, year, prostate-specific antigen, grade group, and tumor-node-metastasis stage. For each treatment, logistic regression models were fitted for risk of PC death, separately for the SA and CA, and using the same covariates as for the treatment allocation model. Treatment probabilities were multiplied by estimated PC death risks for each treatment based on one arm, and then summed and compared with the observed number of deaths.
RESULTS AND LIMITATIONS


The difference between the observed and estimated treatment distributions (hormonal therapy, radical prostatectomy, radiotherapy, and active surveillance/watchful waiting) in the two arms ranged from -3.3% to 3.3%. These figures, which represent the part of the treatment differences between arms that cannot be explained by clinicopathological differences, are small compared with the observed differences between arms that ranged between 7.2% and 10.1%. The difference between the observed and estimated numbers of PC deaths among men with PC was 0.05% (95% confidence interval [CI] -0.1%, 0.2%) when applying the CA model to the SA, had the two groups received identical primary treatment, given their clinical characteristics. When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%). Consistency of the results of the models demonstrates the robustness of the modeling approach. As the observed difference between trial arms was 4.2%, our findings suggest that differential treatment explains only a trivial proportion of the main findings of ERSPC. A limitation of the study is that only data on primary treatment were available.
CONCLUSIONS


Use of prostate-specific antigen remains the predominant explanation for the reduction in PC mortality seen in the ERSPC trial and is not attributable to differential treatment between trial arms.
PATIENT SUMMARY


This study shows that prostate cancer deaths in the European screening trial (European Randomized Study of Screening for Prostate Cancer) were prevented because men were diagnosed and treated earlier through prostate-specific antigen screening, and not because of different, or better, treatment in the screening arm compared with the control arm.",2019,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).",['A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up'],[],"['numbers of PC deaths', 'PC deaths', 'PC death risks', 'radical prostatectomy, radiotherapy, and active surveillance/watchful waiting', 'PC mortality reduction', 'Prostate Cancer Mortality']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",14136.0,0.0787604,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).","[{'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'School of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Urology, Gothenborg, Sweden. Electronic address: jonas@urol.se.'}]",European urology,['10.1016/j.eururo.2019.03.010']
689,27189694,Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation.,"Objective


This study described the prospective relationship between pharmacological and behavioral measures of 6-mercaptopurine (6MP) medication adherence in a multisite cohort of pediatric patients diagnosed with cancer ( N  = 139).
Methods


Pharmacological measures (i.e., metabolite concentrations) assessed 6MP intake. Behavioral measures (e.g., electronic monitoring) described adherence patterns over time.
Results


Three metabolite profiles were identified across 15 months: one group demonstrated low levels of both metabolites (40.8%) consistent with nonadherence and/or suboptimal therapy; two other groups demonstrated metabolite clusters indicative of adequate adherence (59.2%). Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
Conclusions


To our knowledge, this was the first study to prospectively validate a pharmacological measure of medication adherence with a behavioral adherence measure in a relatively large sample of pediatric patients with cancer. Using multiple methods of adherence measurement could inform clinical care and target patients in need of intervention.",2017,"Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
","['pediatric patients diagnosed with cancer ( N \u2009=\u2009139', 'Pediatric Cancer', 'pediatric patients with cancer']",['6-mercaptopurine (6MP) medication adherence'],"['metabolite clusters indicative of adequate adherence', 'adherence patterns over time', 'low levels of both metabolites', 'behavioral adherence rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]","[{'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0236292,"Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Rohan', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Pediatrics, University of Cincinnati School of Medicine, OH, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Alderfer', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, PA, USA.""}, {'ForeName': 'Crista', 'Initials': 'C', 'LastName': 'Wetherington Donewar', 'Affiliation': ""Center for Pediatric Psychiatry, Children's Medical Center Dallas, Texas, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.'}, {'ForeName': 'Ernest R', 'Initials': 'ER', 'LastName': 'Katz', 'Affiliation': ""Division of General Pediatrics, Children's Hospital Los Angeles, CA, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Muriel', 'Affiliation': ""Division of Psychosocial Oncology, Dana-Farber Cancer Institute and Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': 'Department of Pediatrics, University of Cincinnati School of Medicine, OH, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Drotar', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsw039']
690,30919704,Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC ®  in mite allergic subjects with asthma.,"Objective:  Environmental Exposure Chamber (EEC) should have standardized and controlled allergenic and non-allergenic exposures to perform reproducible clinical studies. The aim was to demonstrate that mite exposure in the Alyatec ®  EEC could induce early (EAR) and/or late asthmatic reactions (LAR) in at least 60% of subjects allergic to mite. Methods:  The EEC has a volume of 147-m 3  with 20 seats. The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured. Twenty-four asthmatics allergic to mite were randomly exposed to 15, 25, and 46 ng/m 3  Der p1. Specificity was assessed in not mite-sensitized asthmatics. Results:  No significant endotoxin or VOC contamination was measured. The mean inter-assay CVs were 12.5% for the airborne particle number and 28.7% for airborne Der p1 concentrations. For the three Der p1 concentrations, at least 88% of the subjects developed EAR and/or LAR, and at least 46% developed a dual response. No reaction occurred with placebo or in the control group. No severe bronchial reaction occurred. Conclusions:  The Alyatec ®  EEC demonstrated a tight control of allergenic and non-allergenic exposures. The EEC was clinically validated, with airborne Der p1 levels close to levels found in natural settings.",2020,"The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured.","['mite allergic subjects with asthma', 'Twenty-four asthmatics allergic to mite']","['Strasbourg environmental exposure chamber (EEC', 'placebo', 'Environmental Exposure Chamber (EEC']","['Specificity', 'mean inter-assay CVs', 'severe bronchial reaction', 'endotoxin or VOC contamination', 'EAR and/or LAR', 'airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations']","[{'cui': 'C0026231', 'cui_str': 'Mites'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",24.0,0.0230995,"The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured.","[{'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Khayath', 'Affiliation': 'Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Doyen', 'Affiliation': 'Clinics of Immuno-Allergology, CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Gherasim', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Radu', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Choual', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Beck', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schoettel', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vecellio', 'Affiliation': 'François-Rabelais University, Tours Cedex, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Domis', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'de Blay', 'Affiliation': 'Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1563902']
691,31700206,Is PFNA-II a better implant for stable intertrochanteric fractures in elderly population ? A prospective randomized study.,"Introduction


Intertrochanteric fracture is one of the most common and severe fractures occurring in the elderly population. We conducted a randomized prospective study to compare the functional and radiological outcome of Proximal Femoral Nail anti-rotation-Asia(PFNA-II) and Dynamic Hip screw (DHS) used in fixation of stable (AO type 31 A1-A2.1) intertrochanteric fractures in elderly.
Methods


60 elderly patients with stable intertrochanteric fractures treated with DHS and PFNA-II between August 2014 to Dec 2016 were enrolled in the study. Intraoperative variables-surgical time, blood loss, fluoroscopy time and post-operative variables-union rate, change in neck shaft angle(NSA), functional outcome in terms of Modified Harris Hip Score(HHS) & SF-12, complication rate and mortality at one year were studied and compared between both the groups.
Results


The mean age of patients in our study was 70.96 years. We found patients treated with DHS required significantly longer surgical time and had more blood loss compared to PFNA-II group. However, there was no significant difference in both the groups in terms of intra-operative fluoroscopy time, change in neck shaft angle, union rate, complication rate and Modified Harris Hip Score & SF-12 at three months; six months and one year follow-up.
Conclusions


Both DHS and PFNA-II can be used effectively in the treatment of elderly patients with stable intertrochanteric fracture with comparable outcome. However, in high-risk elderly patients requiring shorter surgical time and less blood loss, PFNA-II can be used.",2019,We found patients treated with DHS required significantly longer surgical time and had more blood loss compared to PFNA-II group.,"['60 elderly patients with stable intertrochanteric fractures treated with DHS and PFNA-II between August 2014 to Dec 2016 were enrolled in the study', 'stable (AO type 31 A1-A2.1) intertrochanteric fractures in elderly', 'elderly patients with stable intertrochanteric fracture']","['DHS', 'angle(NSA', 'Proximal Femoral Nail anti-rotation-Asia(PFNA-II) and Dynamic Hip screw (DHS']","['Modified Harris Hip Score(HHS) & SF-12, complication rate and mortality', 'intra-operative fluoroscopy time, change in neck shaft angle, union rate, complication rate and Modified Harris Hip Score & SF-12', 'longer surgical time', 'Intraoperative variables-surgical time, blood loss, fluoroscopy time and post-operative variables-union rate, change in neck shaft', 'blood loss']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C2960598', 'cui_str': 'Modified Harris hip score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.0166389,We found patients treated with DHS required significantly longer surgical time and had more blood loss compared to PFNA-II group.,"[{'ForeName': 'Navin Kumar', 'Initials': 'NK', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Trikha', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Gamanagatti', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Avtar Singh', 'Initials': 'AS', 'LastName': 'Balawat', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Palaniswamy', 'Initials': 'P', 'LastName': 'Aravindh', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amrut Raje', 'Initials': 'AR', 'LastName': 'Diwakar', 'Affiliation': 'Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.02.004']
692,31700214,A novel single myocapsular sleeve (SMS) repair technique to reduce dislocation in posterior approach to the hip: A clinico-radiographic study.,"Background


To assess a new modification of posterior approach to the hip and its effect on stability and functional outcome in total hip arthroplasty.
Material & Methods


A comparative retrospective study was done to assess the functional outcome and rate of dislocation among 233 hips (Group A) operated by conventional posterior approach and 567 hips (Group B) by our novel modified posterior approach. In this technique, 2-3 stay sutures are applied in external rotators, then a single conjoint-myocapsular sleeve is raised linearly over the capsule with adherent fibers of gluteus minimus to piriformis tendon, short rotators and part of quadratus for exposure of femoral head. After inserting the definite prosthesis, upper part of sleeve (capsule, piriformis tendon) is sutured at the lower part of tip of greater trochanter & lower part with lateral trochanteric bone. Fifty patients, using randomised tables, in group B underwent MRI to evaluate the efficacy of the repair at 1 and 12 weeks postoperatively.
Results


Average Harris hip score at minimum 3.9 year follow up was 83.2 in Group A & 88.7 in Group B. Group B had only one dislocation (0.176%) while Group A had 12 dislocations (5.15%). MRI showed intact repair in 47 patients (94%); fibrous continuity in 2 patients (6%) in group B patients.
Conclusion


Intermediate results shows that this technique provides enhanced stability and improved functional outcome. But more prospective and randomised controlled studies with long term followup are required to confirm its role in prevention of hip dislocations.",2019,"MRI showed intact repair in 47 patients (94%); fibrous continuity in 2 patients (6%) in group B patients.
","['233 hips (Group A) operated by conventional posterior approach and 567 hips (Group B) by our novel modified posterior approach', 'hip', 'Fifty patients', 'total hip arthroplasty']",['myocapsular sleeve (SMS) repair technique'],"['stability and improved functional outcome', 'stability and functional outcome', 'functional outcome and rate of dislocation', 'fibrous continuity', 'Average Harris hip score']","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0439709', 'cui_str': 'Fibrous (qualifier value)'}, {'cui': 'C0456391', 'cui_str': 'Continuities (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}]",50.0,0.0223553,"MRI showed intact repair in 47 patients (94%); fibrous continuity in 2 patients (6%) in group B patients.
","[{'ForeName': 'Chandra Shekhar', 'Initials': 'CS', 'LastName': 'Yadav', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Samarth', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Shivanand', 'Initials': 'S', 'LastName': 'Gamanagatti', 'Affiliation': 'Department of Radiology, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department Orthopaedics, Saudi German Hospital, Dubai, United Arab Emirates.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.03.014']
693,30922990,"Tiotropium Is Efficacious in 6- to 17-Year-Olds with Asthma, Independent of T2 Phenotype.","BACKGROUND


Tiotropium add-on therapy has demonstrated efficacy and safety in 6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids (ICSs), with or without additional controllers. Pediatric patients often have a significant allergic component to their asthma.
OBJECTIVE


To explore whether responses to tiotropium add-on were influenced by patients' type 2 status, assessed by serum IgE levels and blood eosinophil counts.
METHODS


Data from 2 phase III trials in symptomatic moderate asthma (CanoTinA-asthma; RubaTinA-asthma) and 2 phase III trials in symptomatic severe asthma (VivaTinA-asthma; PensieTinA-asthma) were pooled by severity. Patients were treated with tiotropium 5 μg, tiotropium 2.5 μg, or placebo (2 puffs once daily via Respimat inhaler), as add-on to ICSs, with or without additional controllers. Modeling of efficacy outcomes was performed over the whole range of baseline IgE levels and blood eosinophil counts, and the treatment effect of the tiotropium doses was presented graphically.
RESULTS


Improvements with tiotropium in peak FEV 1  within 3 hours postdose, trough FEV 1 , forced expiratory flow at 25% to 75% of the pulmonary volume, and FEV 1 /forced vital capacity responses were generally consistent across the range of baseline IgE levels and blood eosinophil counts. Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
CONCLUSIONS


This exploratory analysis suggests that improvements with tiotropium as add-on to ICSs, with or without additional controllers, in 6- to 17-year-olds with symptomatic asthma do not vary according to systemic markers of T2 inflammation, namely, total IgE and blood eosinophil counts.",2019,"Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
","['Data from 2 phase III trials in symptomatic moderate asthma (CanoTinA-asthma; RubaTinA-asthma) and 2 phase III trials in symptomatic severe asthma (VivaTinA-asthma; PensieTinA-asthma', 'Pediatric patients often have a significant allergic component to their asthma', '6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids (ICSs), with or without additional controllers']","['Tiotropium', 'tiotropium', 'tiotropium 2.5 μg, or placebo']","['peak FEV 1  within 3 hours postdose, trough FEV 1 , forced expiratory flow', 'blood eosinophil counts', 'Asthma Control Questionnaire responder rates', 'baseline IgE levels and blood eosinophil counts', 'FEV 1 /forced vital capacity responses', 'efficacy and safety', 'serum IgE levels and blood eosinophil counts', 'total IgE and blood eosinophil counts']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.317722,"Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""The Breathing Institute, Children's Hospital of Colorado, Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'Department of Pediatric Pneumology and Allergology, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Goldstein', 'Affiliation': 'Island Medical Research, Rockville Centre, New York, NY.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Mansfield', 'Affiliation': 'Western Sky Medical Research, El Paso, Texas.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Zaremba-Pechmann', 'Affiliation': 'Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'TA Respiratory Diseases, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Eckard', 'Initials': 'E', 'LastName': 'Hamelmann', 'Affiliation': ""Children's Center Bethel, Evangelisches Klinikum Bethel, Bielefeld, Germany; Allergy Center of the Ruhr University, Bochum, Germany.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.03.019']
694,30655277,Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness  versus  tiotropium alone in COPD.,"The 3-min constant speed shuttle test (CSST) was used to examine the effect of tiotropium/olodaterol compared with tiotropium at reducing activity-related breathlessness in patients with chronic obstructive pulmonary disease (COPD).This was a randomised, double-blind, two-period crossover study including COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8. Patients received 6 weeks of tiotropium/olodaterol 5/5 µg and tiotropium 5 µg in a randomised order with a 3-week washout period. The speed for the 3-min CSST was determined for each patient such that an intensity of breathing discomfort ≥4 (""somewhat severe"") on the modified Borg scale was reached at the end of a completed 3-min CSST.After 6 weeks, there was a decrease in the intensity of breathlessness (Borg dyspnoea score) at the end of the 3-min CSST from baseline with both tiotropium (mean -0.968, 95% CI -1.238- -0.698; n=100) and tiotropium/olodaterol (mean -1.325, 95% CI -1.594- -1.056; n=101). The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.",2019,"The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.","['COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8', 'patients with chronic obstructive pulmonary disease (COPD).This', 'dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation', 'COPD']","['tiotropium', 'tiotropium/olodaterol', 'tiotropium/olodaterol 5/5\u2005µg and tiotropium', '3-min constant speed shuttle test (CSST']","['decrease in breathlessness', 'activity-related breathlessness', 'intensity of breathlessness (Borg dyspnoea score']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test (procedure)'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.181198,"The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol  versus  tiotropium (treatment difference -0.357, 95% CI -0.661- -0.053; p=0.0217).Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, QC, Canada.'}, {'ForeName': 'Joseph-Leon', 'Initials': 'JL', 'LastName': 'Aumann', 'Affiliation': 'Longartsenpraktijk, Hasselt, Belgium.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Kirsten', 'Affiliation': 'Pulmonary Research Institute, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Nadreau', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, QC, Canada.'}, {'ForeName': 'Hemani', 'Initials': 'H', 'LastName': 'Macesic', 'Affiliation': 'Boehringer Ingelheim Canada, Burlington, ON, Canada.'}, {'ForeName': 'Xidong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'Boehringer Ingelheim Canada, Burlington, ON, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Queen's University and Kingston General Hospital, Kingston, ON, Canada.""}]",The European respiratory journal,['10.1183/13993003.02049-2018']
695,31888419,Taking another's perspective promotes right parieto-frontal activity that reflects open-minded thought.,"Critical thinking (CT) is important for consensus building. Although the practice of CT using debate is widely used to improve open-minded thought, the cognitive processes underlying this improvement remain poorly understood. Here, functional magnetic resonance imaging (fMRI) was employed to assess how neural responses while considering another's opinion are changed by CT practice and to determine whether the cortical network showing activation changes related to personality traits is relevant to consensus building. A total of 52 healthy participants were divided into three groups for an intervention; the participants read another's reasoning regarding a controversial issue and judged whether this person's viewpoint was affirmative during fMRI measurements. The intervention required them to prepare speech texts from a designated viewpoint based on both themselves and others. Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition. Additionally, activation of the orbitofrontal cortex was negatively correlated with a stubbornness index. The results provide the first neural evidence of the effects of CT practice and support the notion that open-minded thought underlies the benefits of this practice.",2020,"Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition.",['52 healthy participants'],"['Critical thinking (CT', 'functional magnetic resonance imaging (fMRI']",['activation of the orbitofrontal cortex'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C2331062', 'cui_str': 'Orbital Area'}]",52.0,0.0191253,"Compared to the control group, the group who took another's perspective showed enhanced activation of the right parieto-frontal network, that has been implicated in belief update, cognitive reappraisal of emotion, and self-perspective inhibition.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Miura', 'Affiliation': 'Faculty of Engineering, Tohoku Institute of Technology , Sendai, Miyagi, Japan.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Sugiura', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Center for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology , Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Yukako', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Kanan', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Graduate School of Engineering, Tohoku University , Sendai, Miyagi, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Institute of Development, Aging and Cancer, Tohoku University , Sendai, Miyagi, Japan.'}]",Social neuroscience,['10.1080/17470919.2019.1710249']
696,30573354,Female sex hormones in relation to insulin resistance after hysterectomy: A pilot study.,"BACKGROUND & AIM


Surgery causes development of insulin resistance. Women undergoing hysterectomy have different female sex hormonal status, ranging from premenopausal to postmenopausal. The aim of the study was to explore the relation between the female sex hormones and insulin resistance (IR%) after hysterectomy.
METHODS


A secondary analysis from a randomised controlled single-centre study at the Department of Obstetrics and Gynaecology, Örebro University Hospital, Sweden. Twenty women were randomised to robot-assisted laparoscopic or abdominal hysterectomy. Blood were drawn before and after surgery for measurement of oestrogens, progesterone, and gonadotropins alongside determination of insulin sensitivity using the hyperinsulinemic normolycaemic clamp.
RESULTS


Female sex hormonal status was not correlated to insulin sensitivity before operation. Premenopausal women developed more IR% than postmenopausal women (p = 0.012). Premenopausal women also showed a significant decrease in absolute levels of oestradiol (E2) (p = 0.016), and the relative decrease in E2 from preoperative to postoperative values (E2%) was significantly higher (p = 0.001). There was a significant positive correlation in the entire study population between E2% and IR% (r = 0.72, p = 0.001, r 2  0.51) that remained when adjusted for age (p = 0.028), BMI (p = 0.001), and preoperative insulin sensitivity (p = 0.011) separately.
CONCLUSIONS


Premenopausal women developed a higher degree of postoperative insulin resistance that was associated with a parallel relative change in oestradiol levels compared with the postmenopausal women. It remains unclear whether these are independent phenomena in the overall stress response or whether a causal relationship exists.",2019,Premenopausal women developed more IR% than postmenopausal women (p = 0.012).,"['Women undergoing hysterectomy have different female sex hormonal status, ranging from premenopausal to postmenopausal', 'Twenty women', 'Premenopausal women', 'Department of Obstetrics and Gynaecology, Örebro University Hospital, Sweden']",['robot-assisted laparoscopic or abdominal hysterectomy'],"['preoperative insulin sensitivity', 'BMI', 'postoperative insulin resistance', 'absolute levels of oestradiol (E2', 'oestradiol levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}]",20.0,0.208507,Premenopausal women developed more IR% than postmenopausal women (p = 0.012).,"[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Wijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Örebro University Hospital, Sweden; School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Sweden. Electronic address: lena.wijk@oru.se.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Ljungqvist', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Sweden; Department of Surgery, Örebro University Hospital, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Sweden.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.027']
697,30882160,Treatment Satisfaction with Flexible-dose Fesoterodine in Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy: A Multicenter Single-Arm Clinical Study.,"PURPOSE


We investigated treatment satisfaction with flexible-dose fesoterodine in patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy.
MATERIALS AND METHODS


The subjects were prescribed fesoterodine 4 mg for 4 weeks and fesoterodine 4 mg or 8 mg for another 8 weeks. The primary end point of this study was patients' satisfaction after 12 weeks of fesoterodine treatment on a five-point Likert scale. Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
RESULTS


Overall, 84 patients were assigned to the treatment group in this study and 63 patients completed the 12-week treatment course. A final fesoterodine dose of 4 mg and 8 mg was used by 45 (71.4%) and 18 (28.6%) patients, respectively. The satisfaction and dissatisfaction rates at 12 weeks were 69.9% and 14.2%, respectively. Mean changes in the daytime micturitions (9.73 ± 4.72 vs. 7.76 ± 2.86), urgency episodes (7.73 ± 5.68 vs. 3.71 ± 4.09), and nocturnal micturitions (2.13 ± 1.36 vs. 1.68 ± 1.12) in 24 hours improved significantly with flexible-dose fesoterodine treatment (P < .05). Most adverse events were mild and none were severe.
CONCLUSION


The flexible dose fesoterodine represents an alternative treatment modality in patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea.",2020,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","['patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy', 'patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea', '84 patients', 'Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy']","['fesoterodine', 'Flexible-dose Fesoterodine', 'flexible-dose fesoterodine']","['change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment', 'satisfaction and dissatisfaction rates', 'urgency episodes', 'five-point Likert scale', 'nocturnal micturitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",84.0,0.045367,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","[{'ForeName': 'Jin Bong', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea. c-sparrow@hanmail.net.""}, {'ForeName': 'Kang Jun', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}, {'ForeName': 'Won Hee', 'Initials': 'WH', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Inha University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Young-Ho', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'In Rae', 'Initials': 'IR', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Ilsanpaik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Urology, School of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, National Health Insurance Service, Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}]",Urology journal,['10.22037/uj.v0i0.4650']
698,30882163,Effects of Isothermic Irrigation on Core Body Temperature During Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia: A Randomized Controlled Trial.,"Purpose? Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery. The current study is designed to study the effect of isothermic hydration on core temperature in patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia. Materials and Methods? Sixty patients allocated randomly into two groups. In GroupW (n = 30) irrigation fluid at 37°C was used whereas at room temperature in GroupRT (n = 30). Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine. Core temperature, shivering, and hemodynamic parameters were measured every minute until 10th minute and five minute intervals until the end of operation. Shivering and surgeon comfort was also recorded. The primary outcome was the core temperature at the end of surgery. Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests were used where eligible for the statistical analysis.Results? Baseline core temperature was 36.6 ± 0.4°C in GroupW and 36.6 ± 0.5°C in GroupRT (P = .097) which decreased to 36.0 ± 0.5°C and 35.2 ± 0.7°C respectively (P = .018) at the end of operation.  Shivering was observed in 36.7% (n = 11) in GroupRT and 6.7% (n = 2) in GroupW (P = .012). Hemodynamic parameter changes and demographic data were not significant between groups.Conclusion? Isothermic irrigation decreases both the reduction in core temperature and the incidence of shivering while increasing the surgeon comfort.",2020,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"['patients undergoing endoscopic urethral stone treatment surgery', 'Sixty patients allocated randomly into two groups', 'patients undergoing transurethral resection of prostate gland', 'patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia']","['Isothermic irrigation', 'Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine', 'Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia', 'isothermic hydration', 'Isothermic Irrigation']","['Shivering', 'core temperature at the end of surgery', 'Core Body Temperature', 'Shivering and surgeon comfort', 'Core temperature, shivering, and hemodynamic parameters', 'Hemodynamic parameter changes and demographic data', 'Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}]","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}]",60.0,0.0455054,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Canturk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey. drmcanturk@gmail.com.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Hakki', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kocaoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4524']
699,31709920,Individual cognitive behavioral therapy and combined family/individual therapy for young adults with Anorexia nervosa: A randomized controlled trial.,"Objective:  In this study, we evaluate the efficacy of outpatient individual cognitive behavioral therapy for young adults (CBT-YA) and combined family/individual therapy for young adults (FT-YA) for anorexia nervosa (AN).  Method:  Participants (aged 17-24 years) with AN in Sweden were recruited and assigned to 18 months of CBT-YA or FT-YA. Treatment efficacy was assessed primarily using BMI, presence of diagnosis, and degree of eating-related psychopathology at post-treatment and follow-up. Secondary outcomes included depression and general psychological psychopathology. The trial was registered at http://www.isrctn.com/, ISRCTN (25181390).  Results:  Seventy-eight participants were randomized, and seventy-four of them received allocated treatment and provided complete data. Clinical outcomes from within groups resulted in significant improvements for both groups. BMI increased from baseline (CBT-YA 16.49; FT-YA 16.54) to post-treatment (CBT-YA 19.61; FT-YA 19.33) with high effect sizes. The rate of weight restoration was 64.9% in the CBT-YA group and 83.8% in the FT-YA group. The rate of recovery was 76% in both groups at post-treatment, and at follow-up, 89% and 81% had recovered in the CBT-YA and FT-YA groups respectively.  Conclusions:  Outpatient CBT-YA and FT-YA appear to be of benefit to young adults with AN in terms of weight restoration and reduced eating disorder and general psychopathology.",2020,BMI increased from baseline (CBT-YA 16.49; FT-YA 16.54) to post-treatment (CBT-YA 19.61; FT-YA 19.33) with high effect sizes.,"['Participants (aged 17-24 years) with AN in Sweden', 'Seventy-eight participants were randomized, and seventy-four of them received allocated treatment and provided complete data', 'young adults with Anorexia nervosa', 'young adults (CBT-YA', 'young adults (FT-YA) for anorexia nervosa (AN']","['Individual cognitive behavioral therapy and combined family/individual therapy', 'outpatient individual cognitive behavioral therapy', 'CBT-YA or FT-YA']","['rate of recovery', 'rate of weight restoration', 'depression and general psychological psychopathology', 'BMI', 'BMI, presence of diagnosis, and degree of eating-related psychopathology']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",78.0,0.0558437,BMI increased from baseline (CBT-YA 16.49; FT-YA 16.54) to post-treatment (CBT-YA 19.61; FT-YA 19.33) with high effect sizes.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nyman-Carlsson', 'Affiliation': 'School of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Norring', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ingemar', 'Initials': 'I', 'LastName': 'Engström', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Sanna Aila', 'Initials': 'SA', 'LastName': 'Gustafsson', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Lindberg', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Paulson-Karlsson', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Nevonen', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1686190']
700,31706728,Effectiveness of a nursing training intervention in complex chronic patients.,"OBJECTIVE


To evaluate whether a training intervention performed by nursing professionals in complex chronic patients, during hospitalisation in an internal medicine service, can modify the pattern of readmissions or reduce their number.
METHOD


Pragmatic clinical trial of a nursing training intervention vs. habitual performance. For the intervention group, a training plan in care was designed, personalised for each patient, according to the needs detected in a first interview. The intervention was extended during the time of admission and a contact phone was available after discharge to resolve doubts.
RESULTS


Among the 498 patients interviewed initially, 131 were excluded because they were not a complex chronic patient or because they found no deficiencies in their training or care. One patient (.20%) did not agree to participate and there were no dropouts. Of the 366 participants, 190 were included in the intervention group and 176 in the control group. In the first 8 days after discharge, 2 (1.05%) patients from the intervention group and 8 (4.54%) from the control group were re-admitted (p=.05). In the first 30 days after discharge, 26 patients (13.70%) and 33 patients (18.75%) respectively (p=.10) were readmitted.
CONCLUSIONS


This study shows how a nursing training intervention during hospitalisation in Internal Medicine in complex chronic patients reduces short-term readmissions.",2020,This study shows how a nursing training intervention during hospitalisation in Internal Medicine in complex chronic patients reduces short-term readmissions.,"['366 participants, 190 were included in the intervention group and 176 in the control group', '498 patients interviewed initially, 131 were excluded because they were not a complex chronic patient or because they found no deficiencies in their training or care', 'complex chronic patients', 'complex chronic patients reduces short-term readmissions']","['nursing training intervention vs. habitual performance', 'training intervention', 'nursing training intervention']",[],"[{'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]",[],366.0,0.0254953,This study shows how a nursing training intervention during hospitalisation in Internal Medicine in complex chronic patients reduces short-term readmissions.,"[{'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Blanco-López', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España. Electronic address: rosa.maria.blanco.lopez@sergas.es.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Fole-Santalla', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Rio-Enríquez', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Quiroga-Mariño', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Barcón-Pajón', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Casariego-Vales', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Servicio Medicina Interna, Hospital Universitario Lucus Augusti, Lugo, España.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.08.008']
701,30899327,Utilizing a family-based economic strengthening intervention to improve mental health wellbeing among female adolescent orphans in Uganda.,"Background


It is estimated that almost 20% of the world's adolescents have experienced or are experiencing a mental health problem. Several factors have been associated with the onset of adolescent mental health disorders, including poverty, child abuse and violence, particularly among adolescent girls. This paper examines the effect of participating in a family-based economic strengthening intervention on the mental health well-being of female adolescent orphans impacted by HIV/AIDS in rural Uganda.
Methods


Data utilized in this study was from the Bridges to the Future Study (2011-2016), an economic empowerment intervention aimed at improving health outcomes of orphaned children. Adolescents were randomly assigned to either the control condition receiving bolstered standard of care services for orphaned adolescents; or one of two treatment conditions receiving bolstered standard of care as well as an economic empowerment intervention comprising of a child development account, a mentorship program and workshops on financial management and microenterprise development. Data was collected at baseline, 12- and 24-months post intervention initiation. Multilinear regression analyses were conducted to examine the impact of an economic empowerment intervention on mental health functioning of female participants over time. Mental health functioning was measured by: (1) the Child Depression Inventory; (2) Beck Hopelessness Scale; and (3) Tennessee Self Concept Scale.
Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts. Specifically, compared to participants in the control condition, participants receiving the intervention reported a reduction in depressive symptoms from baseline to 12-months follow-up (b = - 1.262, 95% CI - 2.476, - 0.047), and an additional 0.645-point reduction between baseline and 24-months follow-up (b = - 1.907, 95% CI - 3.192, - 0.622). Participants receiving the intervention reported significant improvement in their reported self-concept from baseline to 24 months follow-up (b = 3.503 (95% CI 1.469, 5.538) compared to participants in the control condition.
Conclusions


Empowerment of young girls, either in the form of peer mentorship and/or economic strengthening seems to significantly improve the overall mental health functioning of adolescent girls impacted by HIV and AIDS in low-income settings.",2019,"Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts.","['female adolescent orphans impacted by HIV/AIDS in rural Uganda', 'female adolescent orphans in Uganda', 'adolescent girls', 'young girls', 'Adolescents', 'female participants over time']","['control condition receiving bolstered standard of care services for orphaned adolescents; or one of two treatment conditions receiving bolstered standard of care as well as an economic empowerment intervention comprising of a child development account, a mentorship program and workshops on financial management and microenterprise development', 'family-based economic strengthening intervention', 'Utilizing a family-based economic strengthening intervention', 'economic empowerment intervention']","['self-concept', 'depressive symptoms', 'mental health functioning', 'Child Depression Inventory; (2) Beck Hopelessness Scale; and (3) Tennessee Self Concept Scale', 'Mental health functioning', 'overall mental health functioning', 'mental health wellbeing']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0220830', 'cui_str': 'financial management'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582612', 'cui_str': 'Beck hopelessness scale (assessment scale)'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0222045'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0445717,"Results


Analysis results show an improvement in mental health functioning over time among female participants receiving the intervention compared to their control counterparts.","[{'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Kivumbi', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': '3Brown School, Washington University in St. Louis, St. Louis, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'Nabunya', 'Initials': 'N', 'LastName': 'Proscovia', 'Affiliation': '2New York University Silver School of Social Work, New York, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}, {'ForeName': 'Phionah', 'Initials': 'P', 'LastName': 'Namatovu', 'Affiliation': 'International Center for Child Health and Development, P.O. Box 1988, Circular Rd, Masaka, Uganda.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-019-0273-4']
702,31228618,Effect of Sublingual Immunotherapy on Airway Inflammation and Airway Wall Thickness in Allergic Asthma.,"BACKGROUND


The efficacy of the standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) has been demonstrated for respiratory allergic disease. However, the effects of SLIT on inflammation and structural changes of the airways are still unknown.
OBJECTIVE


The aim of this study was to assess the effects of the 6 SQ-HDM SLIT on airway inflammation and airway geometry in allergic asthma and rhinitis.
METHODS


One hundred two asthmatic patients with rhinitis sensitized to HDM were randomized to receive either SLIT plus pharmacotherapy or standard pharmacotherapy alone, for 48 weeks. Fractional exhaled nitric oxide (FeNO), pulmonary function, quantitative computed tomography, and clinical symptoms were performed at baseline and end of the study.
RESULTS


Compared with pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area/body surface area (WA/BSA, P < .001), wall thickness (T/√BSA, P < .001), percentage wall area (WA/Ao, P < .01), increase in luminal area (Ai/BSA, P < .05), improvement of airflow limitation (P < .001), and clinical symptom scores (P < .05). The change in forced expiratory volume in 1 second (FEV 1 ) was correlated with both changes in FeNO and airway dimensions. Multiple regression analysis showed that the change in FeNO was independently associated with an increase in FEV 1  in the SLIT group (r 2  = 0.623, P = .037).
CONCLUSIONS


Adding 6 SQ-HDM SLIT to standard asthma therapy provides a significant improvement in symptoms and pulmonary function compared with pharmacotherapy. Improvement of airflow limitation with SLIT was associated with the decrease in eosinophilic airway inflammation.",2019,"Compared to pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area /body","['allergic asthma and rhinitis', 'One hundred two asthmatic patients with rhinitis sensitized to HDM', 'allergic asthma']","['6 SQ-HDM SLIT', 'SLIT', 'sublingual immunotherapy', 'standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT', 'SLIT plus pharmacotherapy or standard pharmacotherapy alone']","['clinical symptom scores', 'percentage wall area', 'airway wall area /body', 'FEV', 'luminal area', 'Fractional exhaled nitric oxide (FeNO), pulmonary function, quantitative computed tomography and clinical symptoms', 'improvement of airflow limitation', 'airway inflammation and airway wall thickness', 'FeNO', 'wall thickness (T/√BSA', 'symptoms and pulmonary function', 'eosinophilic airway inflammation']","[{'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3539110', 'cui_str': 'house dust mites'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",102.0,0.0200091,"Compared to pharmacotherapy, SLIT demonstrated a significant reduction of FeNO (P < .01), airway wall area /body","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Clinical Allergy, Department of Internal Medicine, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan. Electronic address: hoshino@iuhw.ac.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Shizuoka, Japan.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.06.003']
703,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
704,30859218,One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.,"BACKGROUND


Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis.
METHODS


This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231.
RESULTS


Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
CONCLUSIONS


Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.",2020,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","['patients on hemodialysis with secondary hyperparathyroidism', 'patients receiving hemodialysis']","['intravenous etelcalcetide', 'etelcalcetide', 'placebo']","['vomiting', 'proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product', 'symptomatic hypocalcemia', 'blood', 'nature, frequency, severity and relation to treatment of all adverse events (AEs', 'Ca', 'diarrhea', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020503', 'cui_str': 'Hyperparathyroidism, Secondary'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3713906', 'cui_str': 'velcalcetide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium (procedure)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0005768'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.188422,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Biostatistics, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Kopyt', 'Affiliation': 'Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, Allentown, PA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Martin', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ureña-Torres', 'Affiliation': 'Department of Nephrology and Dialysis, Ramsay-Générale de Santé, Clinique du Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, CO, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz039']
705,30864528,Investigation of the Roles of New Antiepileptic Drugs and Serum BDNF Levels in Efficacy and Safety Monitoring and Quality of Life: A Clinical Research.,"OBJECTIVE


We aimed to determine the therapeutic drug monitoring (TDM) features and the relation to Brain-Derived Neurotrophic Factor (BDNF) of frequently used new antiepileptic drugs (NADs) including lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM). Moreover, we investigated their effect on the quality of life (QoL).
METHODS


Eighty epileptic patients who had been using the NADs, and thirteen healthy participants were included in this cross-sectional study. The participants were randomized into groups. The QOLIE-31 test was used for the assessment of QoL. We also prepared and applied ""Safety Test"". HPLC method for TDM, and ELISA method for BDNF measurements were used consecutively.
RESULTS


In comparison to healthy participants, epileptic participants had lower marriage rate (p=0.049), education level (p˂0.001), alcohol use (p=0.002). BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016). There were negative correlations between serum BDNF levels and serum ZNS levels (p=0.042) with LTGpolytherapy, serum MHD levels (a 10-monohydroxy derivative of OXC, p=0.041) with OXCmonotherapy. There was no difference in BDNF according to monotherapy-polytherapy, drugresistant groups, regarding seizure frequency. There was a positive correlation between total health status and QoL (p˂0.001). QOLIE-31 overall score (OS) was higher in those with OXCmonotherapy (76.5±14.5). OS (p˂0.001), seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function (SF, p˂0.001) were different in the main groups. Forgetfulness was the most common unwanted effect.
CONCLUSION


While TDM helps the clinician to use more effective and safe NADs, BDNF may assist in TDM for reaching the therapeutic target in epilepsy.",2020,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"['Eighty epileptic patients who had been using the NAD, thirteen healthy participants were included in this cross-sectional study', 'Conclussion']","['OXC-monotherapy', 'lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM']","['marriage rate', 'serum MHD levels (10-monohydroxy derivative of OXC', 'BDNF', 'seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function', 'total health status and QoL', 'QOLIE-31 overall score (OS', 'BDNF levels', 'quality of life (QoL', 'serum BDNF levels and serum ZNS levels', 'education level', 'efficacy and safety monitoring and quality of life']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",13.0,0.0902854,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"[{'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Demir', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Emel O', 'Initials': 'EO', 'LastName': 'Akarsu', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Hava O', 'Initials': 'HO', 'LastName': 'Dede', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Bebek', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Sevda O', 'Initials': 'SO', 'LastName': 'Yıldız', 'Affiliation': 'Department of Biostatistics, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Baykan', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Ahmet G', 'Initials': 'AG', 'LastName': 'Akkan', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Cerrahpasa Faculty of Medicine, Istanbul University, Cerrahpasa Street / Fatih 34093, Istanbul, Turkey.'}]",Current clinical pharmacology,['10.2174/1574884714666190312145409']
706,30874378,Effect of suvorexant on nighttime blood pressure in hypertensive patients with insomnia: The SUPER-1 study.,"Orexins are neuropeptides that play a role in maintaining wakefulness and contribute to central regulation of cardiovascular function. This first multicenter, randomized, double-blind study investigated the effects of suvorexant, a reversible dual orexin receptor antagonist, on nighttime blood pressure (BP) in patients with insomnia and hypertension. After a 4-week run-in period, adult outpatients (n = 82) with treated hypertension (clinic SBP <160 mm Hg) and insomnia were treated with suvorexant 20 mg/d or placebo before bedtime for 2 weeks. Twenty-four-hour ambulatory BP monitoring was performed at baseline and the end of treatment, and home BP measurements (morning and evening) were taken daily. Nighttime systolic BP (SBP), the primary endpoint, decreased slightly from baseline to week 2 in both the suvorexant and placebo groups (-4.4 vs -1.8 mm Hg; P = 0.494). Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups. In this study, suvorexant had no overall effect on BP in patients with insomnia and treated hypertension.",2019,"Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups.","['adult outpatients (n\xa0=\xa082) with treated hypertension (clinic SBP <160\xa0mm\xa0Hg) and', 'hypertensive patients with insomnia', 'patients with insomnia and treated hypertension', 'patients with insomnia and hypertension']","['suvorexant 20\xa0mg/d or placebo', 'placebo', 'suvorexant', 'suvorexant, a reversible dual orexin receptor antagonist']","['Nighttime systolic BP (SBP', 'Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring', 'nighttime blood pressure (BP', 'BP', 'nighttime blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0989369,"Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups.","[{'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Yamasaki', 'Affiliation': 'Yamasaki Family Clinic, Hyogo, Japan.'}, {'ForeName': 'Kazuro', 'Initials': 'K', 'LastName': 'Yagi', 'Affiliation': 'Yagi Hospital, Tokyo, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Tsukamoto', 'Affiliation': 'Tsukamoto Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Yukie', 'Initials': 'Y', 'LastName': 'Okawara', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tomitani', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kanegae', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13505']
707,30809646,"Effects of a randomized, culturally adapted, lifestyle intervention on mental health among Middle-Eastern immigrants.","BACKGROUND


Middle-Eastern immigrants in Sweden are at increased risk for type 2 diabetes (T2D) and poor mental health. Physical activity not only prevents/delays onset of T2D but also shows favorable effects on mental health. However, the effects of a culturally adapted lifestyle intervention on mental health among Middle-Eastern immigrants have not been explored before. We aimed to study the effects of a randomized controlled, culturally adapted lifestyle intervention on anxiety and depression levels in diabetes-prone Iraqi immigrants.
METHODS


Participants (n = 96) were randomized to intervention group, IG (n = 50) or control group, CG (n = 46). The IG received seven group sessions addressing lifestyle change and the CG received treatment as usual. Montgomery-Åsberg Depression Rating Scale (MADRS-S) and Hospital Anxiety and Depression Scale (HADS) assessed mental health at start, mid (2 months) and end of the study (4 months). Proportional odds ratio (OR) model was used to study the effect of the intervention.
RESULTS


The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3). The findings persisted after adjustment for age, sex, body mass index, time since migration, sedentary lifestyle and language spoken at home. Group differences were non-significant at visit 2 vs. baseline.
CONCLUSION


A culturally adapted lifestyle intervention addressing T2D prevention in Middle-Eastern immigrants has favorable effects on mental health. The effect was more pronounced at the 4 months than at 2 months follow-up, indicating beneficial effect of longer study duration.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT01420198.",2019,"The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3).","['Participants (n = 96', 'mental health among Middle-Eastern immigrants', 'Middle-Eastern immigrants', 'Middle-Eastern immigrants in Sweden', 'diabetes-prone Iraqi immigrants']","['culturally adapted, lifestyle intervention', 'control group, CG', 'culturally adapted lifestyle intervention']","['Montgomery-Åsberg Depression Rating Scale (MADRS-S) and Hospital Anxiety and Depression Scale (HADS) assessed mental health', 'MADRS-S and HADS depression scale', 'anxiety and depression levels']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1556087', 'cui_str': 'Iraqi (ethnic group)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",96.0,0.0508681,"The odds of scoring lower on MADRS-S and HADS depression scale at visit 3 vs. baseline were higher in the IG compared to the CG (MADRS-S OR 5.9, 95% CI: 1.6-22.5; HADS OR 4.4, 95% CI: 0.9-20.3).","[{'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Lindblad', 'Affiliation': 'Department of Community Medicine/Primary Health Care, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bennet', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}]",European journal of public health,['10.1093/eurpub/ckz020']
708,30821349,Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,"OBJECTIVES/HYPOTHESIS


The aim of this study was to compare the effect of dexmedetomidine and propofol on airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE).
STUDY DESIGN


Prospective, randomized, single-blinded study.
METHODS


Sixty patients age 18 to 65 years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE were randomly allocated to either Group P (N = 30; receiving propofol infusion at 50-150 μg/kg/min) or Group D (N = 30; receiving dexmedetomidine bolus of 1 μg/kg followed by infusion at 0.5-1.0 μg/kg/hr). DISE was done at light sleep and deep sleep. Airway obstruction at tongue base was recorded as primary outcome. Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events during DISE with the two study drugs were recorded as secondary outcomes.
RESULTS


There was a greater degree of obstruction at the tongue base level (P = 0.001) and Oropharynx level (P = 0.017) in Group P compared with Group D during deep sedation. Increase in airway obstruction from light to deep sleep was seen with propofol at the oropharynx (P = 0.0185) and tongue base (P = 0.0108) levels. Two patients (6.6%) in Group D and 10 patients (33.3%) in Group P showed oxygen saturation below the minimum oxygen saturation recorded during polysomnography. Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
CONCLUSIONS


Dexmedetomidine shows a lesser degree of airway collapse and higher oxygen saturation levels at greater sedation depth during DISE. Propofol has a faster onset and emergence from sedation.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:257-262, 2020.",2020,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","['Sixty patients age 18 to 65\u2009years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE', 'drug-induced sleep endoscopy']","['Dexmedetomidine', 'DISE', 'propofol', 'propofol infusion', 'dexmedetomidine and propofol', 'dexmedetomidine', 'Propofol']","['Oropharynx level', 'degree of airway collapse and higher oxygen saturation levels', 'oxygen saturation below the minimum oxygen saturation', 'Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events', 'degree of obstruction', 'airway obstruction from light to deep sleep', 'airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0014540', 'cui_str': 'Epiglottic Cartilage'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]",60.0,0.101284,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005).
","[{'ForeName': 'Tonsy V', 'Initials': 'TV', 'LastName': 'Padiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.27903']
709,30500903,Effect of lifestyle counselling on health-related quality of life in women at high risk for gestational diabetes.,"BACKGROUND


The incidence of gestational diabetes (GDM) is increasing and interventions to curb the detrimental effects of GDM are needed. We have previously reported that a combined diet and physical activity intervention has the potential to reduce GDM among high-risk women. It is also important to know whether the intervention affects health-related quality of life (HRQoL).
METHODS


A total of 378 women at high risk for GDM were randomized into an intervention (lifestyle counselling four times during pregnancy, n=192), or a control group (n=186) before 20 gestational weeks. HRQoL was assessed with the 15D-instrument six times: once during each trimester and at six weeks, six months and 12 months postpartum.
RESULTS


In this study population, the cumulative incidence of GDM was similar in the intervention and the control group (45.7 vs. 44.5%). There was no difference between the 15D scores of the control and intervention groups at any of the time points.
CONCLUSIONS


Combined diet and physical activity intervention did not provide HRQoL benefits in the study. A high prevalence of GDM in both study groups may have confounded the effect of the intervention.",2019,"There was no difference between the 15D scores of the control and intervention groups at any of the time points.
","['women at high risk for gestational diabetes', '378 women at high risk for GDM']","['Combined diet and physical activity intervention', 'combined diet and physical activity intervention', 'intervention (lifestyle counselling', 'lifestyle counselling']","['15D scores', 'health-related quality of life', 'cumulative incidence of GDM', 'HRQoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",378.0,0.0434251,"There was no difference between the 15D scores of the control and intervention groups at any of the time points.
","[{'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Sahrakorpi', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Rönö', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Saila B', 'Initials': 'SB', 'LastName': 'Koivusalo', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Women's Hospital, Helsinki, Finland.""}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Stach-Lempinen', 'Affiliation': 'Department of Obstetrics and Gynecology, South Karelia Central Hospital, Lappeenranta, Finland.'}, {'ForeName': 'Johan G', 'Initials': 'JG', 'LastName': 'Eriksson', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Department of Health and Social Management, Research Centre for Comparative Effectiveness and Patient Safety, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland.'}]",European journal of public health,['10.1093/eurpub/cky248']
710,31705339,"Probiotics in addition to metronidazole for treatment Trichomonas vaginalis in the presence of BV: a randomized, placebo-controlled, double-blind study.","The purpose was to evaluate whether probiotics can increase the effectiveness of antimicrobial therapy. Ninety women with Trichomonas vaginalis (TV) in the presence BV were included in the study of regimens for therapy combination with metronidazole and vaginal probiotics. For 7 days, the probiotics group patients received metronidazole at 500 mg twice a day and 1 capsule of probiotic Gynophilus® vaginally twice a day; the placebo group patients in addition to metronidazole received a placebo instead of a probiotic. For the next 7 days, patients in both groups in order restore normal microflora were given the probiotics vaginally. Before the treatment, on the 4th, 8th, and 15th day of therapy complaints, pH and redox potential of the vaginal fluid were recorded, TV detection culturally, microflora of the vagina with the qPCR-RT and microscopically. Adding probiotics to traditional therapy of TV in the presence of BV increased the likelihood of cure from TV (88.6 and 42.9% in the probiotic and placebo groups, respectively) and from BV (63.6 and 11.9%, respectively). We have found that the addition of probiotics to antimicrobial therapy causes the decrease in the inflammatory response and significant changes in the vagina's physicochemical parameters (decreased of the pH values, increased of the redox potential) already on the fourth day of the therapy. The changes in the metronidazole's antimicrobial action implementation when a probiotic is added are the reason of increasing the TV therapy's effectiveness in the BV presence.",2020,Ninety women with Trichomonas vaginalis (TV) in the presence BV were included in the study of regimens for therapy combination with metronidazole and vaginal probiotics.,['Ninety women with Trichomonas vaginalis (TV) in the presence BV'],"['placebo', 'metronidazole', 'metronidazole and vaginal probiotics', 'Probiotics']",['inflammatory response'],"[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0040919', 'cui_str': 'Trichomona'}, {'cui': 'C3854307', 'cui_str': 'Presence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]",[],90.0,0.125511,Ninety women with Trichomonas vaginalis (TV) in the presence BV were included in the study of regimens for therapy combination with metronidazole and vaginal probiotics.,"[{'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Sgibnev', 'Affiliation': 'Department of the Study of the Mechanisms of Formation Microbial Biocenosis of Humans, Institute of Cellular and Intracellular Symbiosis, Pionerskaya Street, b. 11, of.107, Orenburg, Russian Federation, 460000. sgibnew72@yandex.ru.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kremleva', 'Affiliation': 'Department of the Study of the Mechanisms of Formation Microbial Biocenosis of Humans, Institute of Cellular and Intracellular Symbiosis, Pionerskaya Street, b. 11, of.107, Orenburg, Russian Federation, 460000.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-019-03731-8']
711,956257,The control of pain after Keller's operation by the instillation of local anaesthetic before closure. A prospective controlled trial.,"With the aim of controlling pain after Keller's operation, a solution of a long-acting local anaesthetic was instilled into the field before closure in a series of thirty patients. In a controlled prospective trial this simple technique by itself proved to be significantly better than either foot block at the ankle or the usual analgesics and was free from local or systemic complications.",1976,In a controlled prospective trial this simple technique by itself proved to be significantly better than either foot block at the ankle or the usual analgesics and was free from local or systemic complications.,[],[],[],[],[],[],30.0,0.0176279,In a controlled prospective trial this simple technique by itself proved to be significantly better than either foot block at the ankle or the usual analgesics and was free from local or systemic complications.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dinley', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Dickson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
712,30677539,"Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study.","BACKGROUND


Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.
OBJECTIVE


To evaluate the efficacy and safety of weight-based intravenous reslizumab dosing in patients who have previously failed therapy with omalizumab.
METHODS


We carried out a 24-week prospective, multicenter, open-label, single-group, self-controlled study in patients with severe eosinophilic asthma who had previously failed to respond to omalizumab. The main objective was to determine whether treatment with reslizumab significantly improved asthma symptoms assessed by the Asthma Control Test (ACT) at week 24. Secondary objectives were to evaluate symptoms at weeks 4 and 12, change in FEV 1  at week 24, and the incidence of severe exacerbations over the study period.
RESULTS


Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study. The median ACT score significantly increased from 13.0 (interquartile range, 8.0-18.0) at baseline to 21.0 (interquartile range, 14.0-24.0) at 24 weeks (P = .002). Only 2 of 29 patients developed at least 1 severe exacerbation during follow-up and none of them required hospitalization. Overall, 15 of 25 patients (60%) were considered as being controlled (ACT score of ≥20 and no exacerbations) at week 24. The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019). Adverse events were mostly moderate and within the range of previously reported side effects with reslizumab.
CONCLUSION


Reslizumab is an effective and safe option for patients with severe eosinophilic asthma and a history of omalizumab failure.",2019,The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019).,"['patients who have previously failed therapy with omalizumab', 'patients with severe eosinophilic asthma who had previously failed to respond to omalizumab', 'Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study', 'patients with severe eosinophilic asthma and a history of omalizumab failure', 'Patients with severe allergic and eosinophilic asthma', 'Patients with Severe Asthma with Inadequate Response to Omalizumab']","['reslizumab', 'Reslizumab', 'weight-based intravenous reslizumab']","['Adverse events', 'severe exacerbation', 'median ACT score', 'Efficacy and Safety', 'asthma symptoms', 'severe exacerbations', 'daily systemic corticosteroids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",,0.151391,The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P = .019).,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Pérez de Llano', 'Affiliation': 'Pneumology Service, Hospital Universitario Lucus Agusti, Lugo, Spain. Electronic address: eremos26@hotmail.com.'}, {'ForeName': 'Borja G', 'Initials': 'BG', 'LastName': 'Cosío', 'Affiliation': 'Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Domingo', 'Affiliation': 'Department of Pulmonary Medicine, Corporació Sanitària Parc Taulí, Sabadell, Spain; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Urrutia', 'Affiliation': 'Asthma Unit, Department of Pulmonary Medicine, Hospital Galdakao, Bizkaia, Spain.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Bobolea', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona-Institute for Health Research (IdiBAPS), Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Valero', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona-Institute for Health Research (IdiBAPS), Madrid, Spain.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Entrenas Costa', 'Affiliation': 'Pneumology Service, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Barranco', 'Affiliation': 'CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Marina Malanda', 'Affiliation': 'Department of Pulmonology, Hospital de Cruces, Bilbao, Spain.'}, {'ForeName': 'Luis Prieto', 'Initials': 'LP', 'LastName': 'Andrés', 'Affiliation': 'Allergy Section, Hospital Universitario Dr Peset, Valencia, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Alvarez-Gutiérrez', 'Affiliation': 'Asthma Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.017']
713,29346184,Synergistic Impact of Training Followed by On-Site Support on HIV Clinical Practice: A Mixed-Design Study in Uganda With Pre/Post and Cluster-Randomized Trial Components.,"BACKGROUND


Task shifting can expand antiretroviral therapy access, but little is known about effective approaches to improve clinical practice among midlevel practitioners (MLPs) such as clinical officers, nurses, and midwives. The Integrated Infectious Diseases Capacity Building Evaluation compared training alone with training combined with on-site support (OSS).
METHODS


Two MLPs each from 36 health facilities attended the 5-week Integrated Management of Infectious Disease training. After training, 18 facilities randomly assigned to arm A received OSS for 9 months, whereas 18 arm B facilities did not. Clinical faculty assessed MLP HIV clinical practice on 6 tasks: history taking, physical examination, laboratory investigations, diagnosis, treatment, and patient education. We analyzed the effect of training alone and training combined with OSS as the pre/post change within each arm. We analyzed the incremental effect of OSS with a difference-in-difference analysis that compared changes between arms.
RESULTS


Training alone and training combined with OSS significantly improved clinical practice in patient history taking (13% and 24% increase, respectively), physical examination (54% and 71%), laboratory investigations (32% and 20%), and diagnosis (31% and 51%). Combined training and OSS also improved patient education significantly (72% increase). Effect sizes for training combined with OSS were larger than for training alone except for laboratory investigations, and the effects were robust in sensitivity analyses. The incremental effect of OSS on diagnosis was significant [adjusted relative risk = 1.23; 95% confidence interval = 1.00 to 1.50].
CONCLUSIONS


Combined training and OSS improved MLP HIV clinical practice over training alone and can contribute to continued expansion of access to antiretroviral therapy.",2018,"RESULTS


Training alone and training combined with OSS significantly improved clinical practice in patient history taking (13% and 24% increase, respectively), physical examination (54% and 71%), laboratory investigations (32% and 20%), and diagnosis (31% and 51%).","['Two MLPs each from 36 health facilities attended the 5-week Integrated Management of Infectious Disease training', 'HIV Clinical Practice']","['training alone with training combined with on-site support (OSS', 'OSS', 'training alone and training combined with OSS']","['laboratory investigations', 'clinical practice', 'patient education', 'physical examination']","[{'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]",,0.0900316,"RESULTS


Training alone and training combined with OSS significantly improved clinical practice in patient history taking (13% and 24% increase, respectively), physical examination (54% and 71%), laboratory investigations (32% and 20%), and diagnosis (31% and 51%).","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Burnett', 'Affiliation': 'Accordia Global Health Foundation, Washington, DC.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Mubiru', 'Affiliation': 'Training Department, Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Peace', 'Initials': 'P', 'LastName': 'Imani', 'Affiliation': ""Renal Section, Department of Pediatrics, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Mbonye', 'Affiliation': 'Training Department, Infectious Diseases Institute, College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Colebunders', 'Affiliation': 'Global Health Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium.'}, {'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Weaver', 'Affiliation': 'Department of Global Health, International Training and Education Center for Health (I-TECH), University of Washington, Seattle, WA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001630']
714,30221336,Is A Combination of Antibiotics and Non-Steroidal Anti-Inflammatory Drugs More Beneficial Than Antibiotic Monotherapy For The Treatment of Female Acute Uncomplicated Cystitis? A Randomized Controlled Pilot Study.,"Purpose: To compare the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) combination therapy to single-agent antibiotic therapy for the resolution of symptoms during two restricted activity days in patients with acute uncomplicated cystitis (AUC)Materials and Methods: We performed a prospective, randomized control pilot study. A total of 55 patients were enrolled. Group I (n=28) was treated with cepodoxime (100 mg twice per day), and Group II (n=27) was treated with cepodoxime (100 mg) and aceclofenac (100 mg) twice per day; both groups were treated for three days. Upon dysuria after each administration, the participants entered a value on a numerical pain scale. The primary outcome was whether there were any differences in the decrease rate in pain scale between the two groups.Result: The average age of the 55 patients was 49.9 ± 13.5 years, and prior to the clinical visit, the patients ex-perienced an average of 2.4 ± 2.2 days of dysuria symptoms. The average numerical pain scale score for dysuria was 4.98 ± 2.18. Thirty-four patients (61.8%) showed positive culture results, and E. coli was the most commonly found bacteria, cultured in 32 patients.Fifty-one patients visited the clinic on day 7, and 42 (76.4%) reported symptom improvement, while nine patients (16.3%) had persistent symptoms. The follow-up numerical pain score was 0.39 ± 1.02 points. The pain score was dramatically decreased after medication. No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134). However, group II showed faster symptom resolution (P = 0.035) at the third administration (day 1.5).Conclusion: Combination therapy with NSAIDs and antibiotics for AUC patients can improve symptoms faster during two restricted activity days when patients have difficulty performing daily living activities.",2018,No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134).,"['55 patients were enrolled', 'The average age of the 55 patients was 49.9 ± 13.5 years, and prior to the clinical visit, the patients ex-perienced an average of 2.4 ± 2.2 days of dysuria symptoms', 'Female Acute Uncomplicated Cystitis', 'patients with acute uncomplicated cystitis (AUC)Materials and Methods']","['Antibiotic Monotherapy', 'cepodoxime', 'non-steroidal anti-inflammatory drugs (NSAIDs) combination therapy', 'aceclofenac']","['numerical pain scale', 'faster symptom resolution', 'pain scale', 'pain scale reduction', 'average numerical pain scale score for dysuria', 'pain score', 'symptom improvement', 'persistent symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",55.0,0.0570695,No difference was observed in the magnitude of the pain scale reduction between the two groups (P = 0.134).,"[{'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea. palindromes@hanmail.net.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Cheol Young', 'Initials': 'CY', 'LastName': 'Oh', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Sung Tae', 'Initials': 'ST', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Bang', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Tae Young', 'Initials': 'TY', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Min Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Jin Seon', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.'}, {'ForeName': 'Young Goo', 'Initials': 'YG', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Hallym University Hallym Sacred Heart Hospital, Gyeonggi, Korea.'}, {'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.'}]",Urology journal,['10.22037/uj.v0i0.3716']
715,30796456,The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial.,"AIM


The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICD) in Patients with Non-ischaemic Systolic Heart Failure (HF) on Mortality (DANISH) found no overall effect on all-cause mortality. The effect of ICD implantation on health-related quality of life (HRQoL) remains to be established as previous trials have demonstrated conflicting results. We investigated the impact of ICD implantation on HRQoL in patients with non-ischaemic systolic HF, a prespecified secondary endpoint in DANISH.
METHODS AND RESULTS


In DANISH, a total of 1116 patients with non-ischaemic systolic HF were randomly assigned (1:1) to ICD implantation or usual clinical care (control). Patients completed disease-specific HRQoL as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ; 0-105, high indicating worse). Changes in HRQoL 8 months after randomization were assessed with a mixed-effects model. At randomization, MLHFQ was completed by 935 (84%) patients (n = 472 in the ICD group and n = 463 in the control group) and was reassessed in 274 (58%) and 292 (63%) patients, respectively after 8 months for the primary analysis. Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months [least square mean -7.0 vs. -4.2 (P = 0.13)]. A clinically relevant improvement (decrease ≥5) in the MLHFQ overall score at 8 months was observed in 151 patients in the ICD group and 148 patients in the control group [55% vs. 51%, respectively (P = 0.25)].
CONCLUSION


Implantable cardioverter-defibrillator implantation in patients with non-ischaemic systolic HF did not significantly alter HRQoL compared with patients randomized to usual clinical care.",2019,Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months [least square mean -7.0 vs. -4.2,"['1116 patients with non-ischaemic systolic HF', 'patients with non-ischaemic systolic HF, a prespecified secondary endpoint in DANISH', 'patients with non-ischaemic systolic HF', 'Patients with Non-ischaemic Systolic Heart Failure (HF) on Mortality (DANISH']","['ICD implantation', 'ICD implantation or usual clinical care (control', 'Implantable cardioverter-defibrillator implantation', 'implantable cardioverter-defibrillator implantation', 'Implantable Cardioverter-Defibrillators (ICD']","['disease-specific HRQoL', 'health-related quality of life (HRQoL', 'health-related quality of life', 'MLHFQ', 'MLHFQ overall score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1116.0,0.112485,Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months [least square mean -7.0 vs. -4.2,"[{'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Regitze', 'Initials': 'R', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, University Hospital Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aagaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Korup', 'Affiliation': 'Department of Clinical Epidemiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Flemming H', 'Initials': 'FH', 'LastName': 'Steffensen', 'Affiliation': 'Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Clinical Epidemiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Melchior', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Ole D', 'Initials': 'OD', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Egstrup', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Clinical Epidemiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz018']
716,30737094,Evaluation and Lessons Learned From the Development and Implementation of an Online Prenatal Nutrition Training for EFNEP Paraprofessionals.,"OBJECTIVE


Design, implement, and evaluate the effectiveness of a video-based online training addressing prenatal nutrition for paraprofessional peer educators.
METHODS


Quasi-experimental pre-posttest study with 2 groups of paraprofessionals working for the Expanded Food and Nutrition Education Program in 17 states and US territories: intervention (n = 67) and delayed intervention comparison group (n = 64). An online training was systematically developed using Smith and Ragan's instructional design model, the Cognitive Theory of Multimedia Learning, principles of adult learning, and selected constructs of the Social Cognitive Theory. Changes in knowledge, identification of inappropriate teaching practices, and self-efficacy, were assessed. Within- and between-group comparisons were done using ANCOVA.
RESULTS


The intervention group scored significantly higher (P < .05) in all evaluations compared with preassessments and the comparison group. After delayed intervention, the comparison group scored significantly higher (P < .05) than in preassessments. Paraprofessionals reacted positively to future online trainings and were interested in them.
CONCLUSIONS AND IMPLICATIONS


A video-based online training is an effective method to complement in-person trainings to prepare paraprofessionals to teach nutrition lessons.",2019,The intervention group scored significantly higher (P < .05) in all evaluations compared with preassessments and the comparison group.,['Quasi-experimental pre-posttest study with 2 groups of paraprofessionals working for the Expanded Food and Nutrition Education Program in 17 states and US territories: intervention (n\u202f=\u202f67) and delayed intervention comparison group (n\u202f=\u202f64'],"['video-based online training addressing prenatal nutrition', 'video-based online training']",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]",[],,0.0260519,The intervention group scored significantly higher (P < .05) in all evaluations compared with preassessments and the comparison group.,"[{'ForeName': 'Micheline', 'Initials': 'M', 'LastName': 'Chlipalski', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO. Electronic address: Susan.Baker@colostate.edu.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Olson', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Auld', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.11.013']
717,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
718,30730770,Staying Strong with Schools: Testing an Elementary School-Based Intervention for Military-Connected Children.,"To address the unique behavioral health challenges facing military-connected children (MCC) during parental deployment and reintegration, we developed a low-cost, low-burden school-based intervention, Staying Strong With Schools (SSWS). SSWS builds upon best educational practice by formalizing relationships between administrators, guidance staff, teachers, and parents to enhance social connection to support psychosocial functioning of MCC. We previously evaluated the feasibility and acceptability of the intervention in an open pilot with 2 elementary schools, finding high feasibility and high acceptability. A randomized controlled trial of 10 civilian elementary schools was conducted to examine the efficacy of SSWS. Ten schools were randomly assigned to SSWS versus an educational pamphlet waitlist control condition. Participants included 56 MCC, assessed on measures of behavioral and emotional functioning, perceived social support, and mental health symptoms at the beginning, middle, and end of school year. Over the course of the school year, parents in intervention schools reported their child exhibited less internalizing behavior than nonintervention school parents; there were no differences in parent report of child externalizing behavior. Children in SSWS schools reported greater perceived social support than children in control schools. Findings from this small-scale randomized controlled trial suggest that SSWS might be efficacious in supporting MCC in civilian elementary schools and support a larger scale implementation to test its efficacy further.",2020,"Over the course of the school year, parents in intervention schools reported their child exhibited less internalizing behavior than nonintervention school parents; there were no differences in parent report of child externalizing behavior.","['10 civilian elementary schools', 'Ten schools', 'for Military-Connected Children']","['educational pamphlet waitlist control condition', 'Elementary School-Based Intervention', 'SSWS']","['internalizing behavior', 'child externalizing behavior', 'feasibility and acceptability', 'behavioral and emotional functioning, perceived social support, and mental health symptoms', 'social support']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",10.0,0.0276489,"Over the course of the school year, parents in intervention schools reported their child exhibited less internalizing behavior than nonintervention school parents; there were no differences in parent report of child externalizing behavior.","[{'ForeName': 'Bonnie Y', 'Initials': 'BY', 'LastName': 'Ohye', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital.'}, {'ForeName': 'Rafaella J', 'Initials': 'RJ', 'LastName': 'Jakubovic', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zakarian', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1547971']
719,31689708,Insulin Action in the Hypothalamus Increases Second-Phase Insulin Secretion in Humans.,"BACKGROUND


Animal studies and initial correlative data in humans indicate that insulin action in the brain may affect pancreatic insulin secretion. An important brain region for this process is the hypothalamus, an area that can develop insulin resistance.
METHODS


Fifteen young, healthy men (27 ± 3 years) with a wide BMI spectrum (20-30 kg/m2) underwent 2 hyperglycemic clamps (target blood glucose: 10 mmol/L). In this double-blind study, subjects received 160 U of insulin or placebo as a nasal spray on 2 days in randomized order. On another day, insulin sensitivity of the hypothalamus was determined by functional magnetic resonance imaging.
RESULTS


Glucose levels were comparable on both study days. In the whole group, C-peptide levels were not significantly different between conditions. Though, there was a significant interaction between insulin sensitivity of the hypothalamus × nasal spray × time on C-peptide levels (p = 10-6). The group was therefore divided according to median hypothalamic insulin sensitivity. C-peptide concentrations were higher after intranasal insulin compared to placebo spray in the group with a strong hypothalamic insulin response (p < 0.0001, β = 6.00 ± 1.24) and lower in the brain insulin-resistant group (p = 0.005, β = -2.68 ± 0.95). Neither somatostatin nor glucagon kinetics was altered by the nasal spray.
CONCLUSIONS


In participants with high hypothalamic insulin sensitivity, insulin action in the brain enhanced second-phase insulin secretion from pancreatic beta cells. This reaction could, for example, contribute to late postprandial glucose regulation by suppressing hepatic glucose production by portal venous insulin.",2020,"C-peptide concentrations were higher after intranasal insulin compared to placebo spray in the group with a strong hypothalamic insulin response (p<0.0001, β=6.00±1.24) and lower in the brain insulin resistant group (p=0.005, β=-2.68±0.95).","['15 young, healthy men (27±3 years) with a wide BMI spectrum (20-30 kg/m²) underwent two', 'humans']","['insulin or placebo', 'hyperglycemic clamps (target blood glucose: 10 mmol/l']","['C-peptide concentrations', 'median hypothalamic insulin sensitivity', 'hypothalamic insulin response', 'C-peptide levels', 'Glucose levels', 'somatostatin nor glucagon kinetics']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",15.0,0.0738231,"C-peptide concentrations were higher after intranasal insulin compared to placebo spray in the group with a strong hypothalamic insulin response (p<0.0001, β=6.00±1.24) and lower in the brain insulin resistant group (p=0.005, β=-2.68±0.95).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany, martin.heni@med.uni-tuebingen.de.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Willmann', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Benjamin Assad', 'Initials': 'BA', 'LastName': 'Jaghutriz', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vosseler', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kübler', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Hund', 'Affiliation': 'University Pharmacy, University Hospital, Tübingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Scheffler', 'Affiliation': 'High-Field Magnetic Resonance, Max Planck Institute for Biological Cybernetics, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Peter', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Preissl', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kullmann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Centre Munich at the University of Tübingen (IDM), Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University Hospital, Eberhard-Karls-University Tübingen, Tübingen, Germany.'}]",Neuroendocrinology,['10.1159/000504551']
720,30712901,"Physiological, hyaluronan-selected intracytoplasmic sperm injection for infertility treatment (HABSelect): a parallel, two-group, randomised trial.","BACKGROUND


Sperm selection strategies aimed at improving success rates of intracytoplasmic sperm injection (ICSI) include binding to hyaluronic acid (herein termed hyaluronan). Hyaluronan-selected sperm have reduced levels of DNA damage and aneuploidy. Use of hyaluronan-based sperm selection for ICSI (so-called physiological ICSI [PICSI]) is reported to reduce the proportion of pregnancies that end in miscarriage. However, the effect of PICSI on livebirth rates is uncertain. We aimed to investigate the efficacy of PICSI versus standard ICSI for improving livebirth rates among couples undergoing fertility treatment.
METHODS


This parallel, two-group, randomised trial included couples undergoing an ICSI procedure with fresh embryo transfer at 16 assisted conception units in the UK. Eligible women (aged 18-43 years) had a body-mass index of 19-35 kg/m 2  and a follicle-stimulating hormone (FSH) concentration of 3·0-20·0 mIU/mL or, if no FSH measurement was available, an anti-müllerian hormone concentration of at least 1·5 pmol/L. Eligible men (aged 18-55 years) had not had a vasovasostomy or been treated for cancer in the 24 months before recruitment and were able, after at least 3 days of sexual abstinence, to produce freshly ejaculated sperm for the treatment cycle. Couples were randomly assigned (1:1) with an online system to receive either PICSI or a standard ICSI procedure. The primary outcome was full-term (≥37 weeks' gestational age) livebirth, which was assessed in all eligible couples who completed follow-up. This trial is registered, number ISRCTN99214271.
FINDINGS


Between Feb 1, 2014, and Aug 31, 2016, 2772 couples were randomly assigned to receive PICSI (n=1387) or ICSI (n=1385), of whom 2752 (1381 in the PICSI group and 1371 in the ICSI group) were included in the primary analysis. The term livebirth rate did not differ significantly between PICSI (27·4% [379/1381]) and ICSI (25·2% [346/1371]) groups (odds ratio 1·12, 95% CI 0·95-1·34; p=0·18). There were 56 serious adverse events in total, including 31 in the PICSI group and 25 in the ICSI group; most were congenital abnormalities and none were attributed to treatment.
INTERPRETATION


Compared with ICSI, PICSI does not significantly improve term livebirth rates. The wider use of PICSI, therefore, is not recommended at present.
FUNDING


National Institute for Health Research Efficacy and Mechanism Evaluation Programme.",2019,The term livebirth rate did not differ significantly between PICSI (27·4% [379/1381]) and ICSI (25·2% [346/1371]),"['Eligible women (aged 18-43 years) had a body-mass index of 19-35 kg/m 2  and a follicle-stimulating hormone (FSH) concentration of 3·0-20·0 mIU/mL or, if no FSH measurement was available, an anti-müllerian hormone concentration of at least 1·5 pmol/L. Eligible men (aged 18-55 years) had not had a vasovasostomy or been treated for cancer in the 24 months before recruitment and were able, after at least 3 days of sexual abstinence, to produce freshly ejaculated sperm for the treatment cycle', 'Between Feb 1, 2014, and Aug 31, 2016', 'couples undergoing fertility treatment', 'at 16 assisted conception units in the UK', 'n=1385), of whom 2752 (1381 in the PICSI group and 1371 in the ICSI group) were included in the primary analysis', '2772 couples']","['hyaluronan-selected intracytoplasmic sperm injection', 'ICSI procedure with fresh embryo transfer', 'PICSI versus standard ICSI', 'ICSI, PICSI', 'PICSI', 'hyaluronan-based sperm selection for ICSI', 'PICSI or a standard ICSI procedure', 'ICSI']","['livebirth rates', ""full-term (≥37 weeks' gestational age) livebirth"", '56 serious adverse events', 'term livebirth rates', 'term livebirth rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement (procedure)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0042421', 'cui_str': 'Vasectomy Reversal'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}]","[{'cui': 'C0419373', 'cui_str': 'Livebirth (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2772.0,0.64936,The term livebirth rate did not differ significantly between PICSI (27·4% [379/1381]) and ICSI (25·2% [346/1371]),"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds Laboratories, University of Leeds, Leeds, UK. Electronic address: d.miller@leeds.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, Leeds National Institute for Health Research Clinical Research Facility, University of Leeds, Leeds, UK.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'The Leeds Centre for Reproductive Medicine, Seacroft Hospital, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Forbes', 'Affiliation': 'Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Kirkman-Brown', 'Affiliation': ""Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Women's Hospital, Birmingham Women's and Children's National Health Service (NHS) Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': ""Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Birmingham, UK; Birmingham Women's Hospital, Birmingham Women's and Children's National Health Service (NHS) Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Examen Ltd, Belfast, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cutting', 'Affiliation': 'Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brison', 'Affiliation': ""Department of Reproductive Medicine, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, St Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Pacey', 'Affiliation': 'Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brian', 'Affiliation': 'Royal College of Obstetricians and Gynaecologists, London, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': 'School of Biosciences, University of Kent, Canterbury, UK.'}, {'ForeName': 'Yakoub', 'Initials': 'Y', 'LastName': 'Khalaf', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital, London, UK.""}]","Lancet (London, England)",['10.1016/S0140-6736(18)32989-1']
721,31589074,Intermittent Hypoxia/Hyperoxia Versus Intermittent Hypoxia/Normoxia: Comparative Study in Prediabetes.,"Background:  Intermittent hypoxia/normoxia training (IHT) is considered a possible means to alleviate chronic diseases such as diabetes. In the last decade, another method of intermittent hypoxia/hyperoxia training (IHHT) began to enter the clinical practice, when the periods of breathing with atmospheric air are replaced by breathing a hyperoxic mixture. The present study compared the impact of adaptation to IHHT versus IHT on some metabolic variables in prediabetic patients.  Methods:  A placebo-controlled trial included 55 patients with prediabetes, sea level residents, ages 51-74 years.  Control  Group (16 patients) took sham 3-week course, and the  IHHT  Group (17 patients) and  IHT  Group (22 patients) received similar actual sessions of IHHT or IHT five times a week for 3 weeks, each session consisting four cycles of 5 minutes of hypoxia (12% O 2 ) followed by 3 minutes of hyperoxia (IHHT, 33% O 2 ) or 5 minutes of normoxia (IHT, breathing room air). Fasting glucose, oral glucose tolerance test (OGTT), blood lipids, and the level of blood oxygen saturation (SpO 2 ) were investigated at baseline, as well as 1 day and 1 month after IHHT/IHT termination.  Results:  The study showed the same positive effect of two types of training: equal reduction of serum glucose concentrations, both fasting and 2 hours of OGTT; decreased total blood cholesterol and low-density lipoproteins; and an equally smaller drop in SpO 2  during acute hypoxic test (breathing with 12% O 2  for 20 minutes). Improved parameters persisted 1 month after training termination in both groups.  Conclusion:  One of the advantages of IHHT over IHT observed in this study could be some reduction in the duration of the sessions due to shortening reoxygenation periods. Further studies are required to search for additional beneficial effects of IHHT when using other training modes or other pathologies.",2019,Improved parameters persisted 1 month after training termination in both groups.  ,"['prediabetic patients', '55 patients with prediabetes, sea level residents, ages 51-74 years', 'prediabetes']","['hypoxia/normoxia training (IHT', 'Intermittent hypoxia/hyperoxia versus intermittent hypoxia/normoxia', 'Intermittent Hypoxia/Hyperoxia Versus Intermittent Hypoxia/Normoxia', 'intermittent hypoxia/hyperoxia training (IHHT', 'IHHT  Group (17 patients) and  IHT  Group (22 patients) received similar actual sessions of IHHT or IHT', 'placebo', 'IHHT versus IHT', 'hyperoxia (IHHT, 33% O 2 ) or 5 minutes of normoxia (IHT, breathing room air']","['total blood cholesterol and low-density lipoproteins', 'Fasting glucose, oral glucose tolerance test (OGTT), blood lipids, and the level of blood oxygen saturation (SpO 2 ', 'serum glucose concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",55.0,0.0145439,Improved parameters persisted 1 month after training termination in both groups.  ,"[{'ForeName': 'Tetiana V', 'Initials': 'TV', 'LastName': 'Serebrovska', 'Affiliation': 'Bogomoletz Institute of Physiology, Kiev, Ukraine.'}, {'ForeName': 'Oksana N', 'Initials': 'ON', 'LastName': 'Grib', 'Affiliation': 'D.F. Chebotarev State Institute of Gerontology, Kiev, Ukraine.'}, {'ForeName': 'Volodymyr I', 'Initials': 'VI', 'LastName': 'Portnichenko', 'Affiliation': 'Bogomoletz Institute of Physiology, Kiev, Ukraine.'}, {'ForeName': 'Zoya O', 'Initials': 'ZO', 'LastName': 'Serebrovska', 'Affiliation': 'Bogomoletz Institute of Physiology, Kiev, Ukraine.'}, {'ForeName': 'Egor', 'Initials': 'E', 'LastName': 'Egorov', 'Affiliation': 'CellAir Construction GmbH, Stuttgart, Germany.'}, {'ForeName': 'Valeriy B', 'Initials': 'VB', 'LastName': 'Shatylo', 'Affiliation': 'D.F. Chebotarev State Institute of Gerontology, Kiev, Ukraine.'}]",High altitude medicine & biology,['10.1089/ham.2019.0053']
722,30710211,Effect of Preoperative Administration of Oral Arginine and Glutamine in Patients with Enterocutaneous Fistula Submitted to Definitive Surgery: a Prospective Randomized Trial.,"BACKGROUND


The use of glutamine and arginine has shown several advantages in postoperative outcomes in patients after gastrointestinal surgery. We determined the effects of its use in patients with enterocutaneous fistula after operative treatment.
PATIENTS AND METHODS


Forty patients with enterocutaneous fistula were randomly assigned to one of two groups. The control group received the standard medical care while the patients of the experimental group were supplemented with enteral administration of 4.5 g of arginine and 10 g of glutamine per day for 7 days prior to the surgery. The primary outcome variable was the recurrence of the fistula and the secondary outcomes were preoperative and postoperative serum concentrations of interleukin 6 and C-reactive protein and postoperative infectious complications.
RESULTS


Twenty patients were assigned to each group. The fistula recurred in two patients (10%) of the experimental group and in nine patients (45%) of the control group (P < 0.001). We found a total of 13 infectious complications in six patients of the control group (all with fistula recurrence) and none in the experimental group. Mean preoperative serum concentrations of interleukin 6 and C-reactive protein were lower in patients from the experimental group. In addition, these levels were lower in patients who had recurrence if compared to patients that did not recur.
CONCLUSION


Preoperative administration of oral arginine and glutamine could be valuable in the postoperative recovery of patients with enterocutaneous fistulas submitted to definitive surgery.",2020,Mean preoperative serum concentrations of interleukin 6 and C-reactive protein were lower in patients from the experimental group.,"['Patients with Enterocutaneous Fistula Submitted to Definitive Surgery', 'Twenty patients were assigned to each group', 'patients with enterocutaneous fistulas submitted to definitive surgery', 'patients with enterocutaneous fistula after operative treatment', 'patients after gastrointestinal surgery', 'Forty patients with enterocutaneous fistula']","['standard medical care', 'Oral Arginine and Glutamine', 'glutamine and arginine', 'oral arginine and glutamine', 'enteral administration of 4.5\xa0g of arginine and 10\xa0g of glutamine']","['recurrence of the fistula and the secondary outcomes were preoperative and postoperative serum concentrations of interleukin 6 and C-reactive protein and postoperative infectious complications', 'fistula recurred', 'Mean preoperative serum concentrations of interleukin 6 and C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341318', 'cui_str': 'Enterocutaneous Fistula'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C1318182', 'cui_str': '10G'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",20.0,0.0654817,Mean preoperative serum concentrations of interleukin 6 and C-reactive protein were lower in patients from the experimental group.,"[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Martinez', 'Affiliation': 'Department of General and Gastrointestinal Surgery, UMAE Hospital de Especialidades - Centro Médico Nacional Siglo XXI (Instituto Mexicano del Seguro Social, IMSS), Mexico City, Mexico.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Bosco-Garate', 'Affiliation': 'Unidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades - Centro Médico Nacional Siglo XXI (Instituto Mexicano del Seguro Social, IMSS), Av.Cuauhtémoc 330, 3er piso, Colonia Doctores, Delegación Cuauhtémoc, 06720, Mexico City, Mexico.'}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Souza-Gallardo', 'Affiliation': 'Department of General and Gastrointestinal Surgery, UMAE Hospital de Especialidades - Centro Médico Nacional Siglo XXI (Instituto Mexicano del Seguro Social, IMSS), Mexico City, Mexico.'}, {'ForeName': 'José D', 'Initials': 'JD', 'LastName': 'Méndez', 'Affiliation': 'Unidad de Investigación Médica en Enfermedades Metabólicas, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI (Instituto Mexicano del Seguro Social, IMSS), Mexico City, Mexico.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Juárez-Oropeza', 'Affiliation': 'Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Román-Ramos', 'Affiliation': 'División Ciencias Biológicas y de la Salud, Universidad Autónoma Metropolitana-Iztapalapa, Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferat-Osorio', 'Affiliation': 'Department of General and Gastrointestinal Surgery, UMAE Hospital de Especialidades - Centro Médico Nacional Siglo XXI (Instituto Mexicano del Seguro Social, IMSS), Mexico City, Mexico. eduardoferat@me.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-04099-4']
723,30740877,A randomized controlled trial on the effect of topical phenytoin 2% on wound healing after anal fistulotomy.,"AIM


Laying open fistulotomy is the standard treatment for simple anal fistula. However, healing of the resultant anal wound may be prolonged and may adversely affect a patient's lifestyle and work. This randomized trial aimed to assess the effect of topical phenytoin 2% powder spray on healing of the anal wound following fistulotomy.
METHOD


Adult patients with simple anal fistula who underwent anal fistulotomy were divided into two equal groups: group I applied topical phenytoin 2% powder spray on the anal wound regularly with sitz baths until complete healing was confirmed clinically and group II had regular sitz baths only. The primary outcome of the study was time to complete wound healing. Secondary outcomes were postoperative pain, complications, time to return to work and impact on lifestyle.
RESULTS


Sixty patients (50 of whom were men) with a mean age of 41.4 ± 12.5 years were included. Both groups had comparable pain scores at 1 week after surgery (1 ± 0.83 vs 0.86 ± 0.81; P = 0.51). The duration to complete wound healing was 41.2 ± 2.4 days in group I and 42 ± 2.5 days in group II (mean ± SD, P = 0.21). The time to return to work was 13.5 ± 2.8 days in group I and 14.1 ± 2.6 days in group II (mean ± SD, P = 0.39). No significant differences were noted between the two groups with regard to postoperative complications or impact on lifestyle.
CONCLUSION


The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.",2019,"The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.","['Sixty patients (50 of whom were men) with a mean age of 41.4\xa0±\xa012.5\xa0years were included', 'simple anal fistula', 'Adult patients with simple anal fistula who underwent anal fistulotomy']","['topical phenytoin 2% powder spray', 'topical phenytoin']","['duration to complete wound healing', 'healing of the anal wound following fistulotomy', 'postoperative pain, complications, time to return to work and impact on lifestyle', 'pain scores', 'wound healing', 'wound healing, relieve postoperative pain', 'time to complete wound healing', 'postoperative complications or impact on lifestyle']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0193042', 'cui_str': 'Incision of anal fistula (procedure)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0991579', 'cui_str': 'Powder Spray'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",60.0,0.077507,"The use of topical phenytoin 2% powder spray did not promote wound healing, relieve postoperative pain or accelerate patient recovery after anal fistulotomy for simple anal fistula.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sanad', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Emile', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Thabet', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellaithy', 'Affiliation': 'Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14580']
724,31691810,Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial.,"The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.",2020,"FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3.","['Forty patients receiving', 'acute radiation-induced enteritis (ARE', '19 had cervical cancer and 9 received']","['TJ-14', 'herbal medicine TJ-14', 'herbal medicine', 'chemoradiotherapy', 'pelvic radiotherapy']","['hypokalemia', 'TJ-14 efficacy', 'Stool frequency', 'acute radiation-induced enteritis', 'FACT-G score deterioration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0259795', 'cui_str': 'Radiation enteritis'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]","[{'cui': 'C0256809', 'cui_str': 'TJ 14'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0256809', 'cui_str': 'TJ 14'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0259795', 'cui_str': 'Radiation enteritis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0328494,"FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Murai', 'Affiliation': 'Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Matsuo', 'Affiliation': 'Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Manabe', 'Affiliation': 'Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Takaoka', 'Affiliation': 'Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Kae', 'Initials': 'K', 'LastName': 'Hachiya', 'Affiliation': 'Department of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Otsuka', 'Affiliation': 'Department of Radiology, Okazaki City Hospital, Okazaki, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Shibamoto', 'Affiliation': 'Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",Journal of radiation research,['10.1093/jrr/rrz025']
725,30293457,The effects of vest type dynamic elastomeric fabric orthosis on sitting balance and gross manual dexterity in children with cerebral palsy: a single-blinded randomised controlled study.,"Purpose:  To evaluate the effects of vest type dynamic elastomeric fabric orthosis on posture and balance during sitting and gross manual dexterity and to compare the efficacy of daily wearing time of 2 h versus 6 h. Method:  Twenty-four children with cerebral palsy (CP) aged 3-9 years with GMFCS levels III and IV were randomised to either of three groups: (i) a control group who received only conventional exercise therapy, (ii) dynamic elastomeric fabric orthosis 2 h group who wore the orthosis for 2 h during therapy and dynamic elastomeric fabric orthosis 6 h group who wore the orthosis for 4 h in addition to the 2 h of wear along with therapy during hospital inpatient stay for 2 weeks. Children continued to use dynamic elastomeric fabric orthosis during the post-discharge period. The primary outcome measure was the Sitting Assessment Scale. The secondary outcome measurements were the sitting dimension of Gross Motor Function Measure, Box and Block Test and Parent Satisfaction Survey. Assessments were made before treatment, at post-treatment, at 1-month post-treatment, and at 3-months post-treatment. Sitting Assessment Scale and Box and Block Test were also assessed when immediately after wearing the orthosis. This trial is registered with Clinicaltrials.gov, under number NCT03191552. Results:  All groups showed similar improvements except the control group which showed less improvement in Sitting Assessment Scale scores compared to the dynamic elastomeric fabric orthosis groups. Dynamic elastomeric fabric orthosis groups showed greater improvements compared to the control group in the Sitting Assessment Scale but not in the sitting dimension of Gross Motor Function Measure and Box and Block Test at post-treatment, at 1-month post-treatment and at 3-months post-treatment. When the dynamic elastomeric fabric orthosis groups (2 h versus 6 h) were compared, there were no significant differences in any of the assessments. The Sitting Assessment Scale and Box and Block Test scores also improved immediately after the patients put on the orthosis. At 1-month post-treatment, parents of children in the control group reported less satisfaction than parents of the children in dynamic elastomeric fabric orthosis groups. Conclusions:  Dynamic elastomeric fabric orthosis vest has an immediate effect on the sitting balance and gross manual dexterity. It also provides improvements in posture and balance during sitting. Wearing dynamic elastomeric fabric orthosis vest for 2 h during therapy is as much effective as wearing it for 6 h in children with CP in addition to therapy to improve sitting balance.Implications for rehabilitationDynamic elastomeric fabric orthosis vest provides improvements in sitting balance when used in addition to conventional therapy in children with cerebral palsy.Wearing dynamic elastomeric fabric orthosis for 2 h and wearing dynamic elastomeric fabric orthosis vest for 6 h resulted in similar clinical outcomes.Dynamic elastomeric fabric orthosis vest has an immediate effect on sitting balance and gross manual dexterity in children with cerebral palsy.",2020,Dynamic elastomeric fabric orthosis vest has an immediate effect on sitting balance and gross manual dexterity in children with cerebral palsy.,"['children with cerebral palsy', 'Twenty-four children with cerebral palsy (CP) aged 3-9\xa0years with GMFCS levels III and IV']","['control group who received only conventional exercise therapy, (ii) dynamic elastomeric fabric orthosis 2\u2009h group who wore the orthosis for 2\u2009h during therapy and dynamic elastomeric fabric orthosis 6\u2009h group who wore the orthosis for 4\u2009h in addition to the 2\u2009h of wear along with therapy', 'Dynamic elastomeric fabric orthosis vest', 'vest type dynamic elastomeric fabric orthosis']","['sitting dimension of Gross Motor Function Measure and Box and Block Test', 'Sitting Assessment Scale', 'Sitting Assessment Scale scores', 'Sitting Assessment Scale and Box and Block Test scores', 'sitting dimension of Gross Motor Function Measure, Box and Block Test and Parent Satisfaction Survey', 'satisfaction', 'Sitting Assessment Scale and Box and Block Test', 'sitting balance', 'sitting balance and gross manual dexterity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0444925', 'cui_str': 'elastomeric'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0453884', 'cui_str': 'Waistcoat'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}]",24.0,0.0201244,Dynamic elastomeric fabric orthosis vest has an immediate effect on sitting balance and gross manual dexterity in children with cerebral palsy.,"[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Giray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadag-Saygi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Ozsoy', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sabiha', 'Initials': 'S', 'LastName': 'Gungor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Kayhan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1501098']
726,31462137,The impact of neutrophil-lymphocyte ratio on risk reclassification of patients with advanced renal cell cancer to guide risk-directed therapy.,"Background:  An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC). We examined whether the addition of NLR improves the risk reclassification of advanced RCC using current prognostic tools from the Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Methods:  Using randomised data from the COMPARZ trial of first-line pazopanib vs. sunitinib in advanced RCC, we constructed multivariable models containing MSKCC and IMDC predictor variables with and without NLR. We evaluated model discrimination using the concordance index (C-index). We computed net reclassification improvement to quantify patient reclassification into low/intermediate/poor risk groups with the addition of NLR. Results:  Of 1102 patients, NLR ≥ 5 (16%) was associated with shorter survival adjusting for MSKCC variables (adjusted HR 1.89,  p  < .001). Adding NLR to MSKCC variables increased the C-index by 0.01. Among patients who died before 24 months ( N  = 415), adding NLR reclassified 8% and 2% to a higher and lower risk category, respectively. Among those alive at 24 months ( N  = 636), adding NLR reclassified 4% and 1% to a higher and lower risk category, respectively. This finding translates to a net benefit of eight additional patients who die within 24 months correctly identified as poor risk per 1000 patients tested. We obtained similar results when evaluating NLR with IMDC variables. Conclusions:  NLR does not substantially improve risk reclassification over pre-existing prognostic tools. MSKCC and IMDC classifications remain the standard for guiding risk-directed therapy and trial stratification of patients with advanced RCC.",2020,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"['advanced renal cell carcinoma (RCC', 'patients with advanced RCC', 'patients with advanced renal cell cancer to guide risk-directed therapy']","['pazopanib vs. sunitinib', 'NLR', 'neutrophil-lymphocyte ratio']","['elevated neutrophil-lymphocyte ratio (NLR', 'shorter survival adjusting for MSKCC variables', 'C-index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1102.0,0.032522,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Translational Cancer Research Network, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'H Malcolm', 'Initials': 'HM', 'LastName': 'Hudson', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'Department of Medical Oncology, Liverpool Hospital, Liverpool, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Chee Khoon', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2019.1656342']
727,31630663,"Zumba dancing and aerobic exercise can improve working memory, motor function, and depressive symptoms in female patients with Fibromyalgia.","BACKGROUND


Patients suffering from the Fibromyalgia (FM) have impaired cognitive function, reduced physical activity and more marked depressive symptoms. While physical activity and exercise therapy are not typically part of the standard treatment for this syndrome, there is mounting evidence that regular participation in activities involving physical exertion has a positive impact on psychological functioning in people with FM. This study compares the impact of two different interventions, aerobic exercise training and Zumba dancing, on working memory, motor function and depressive symptoms among female patients with FM. The design also included a control condition.
METHOD


A total of sixty middle-aged female patients with FM (mean age: 35.76 years) and undergoing standard care took part in the study. Participants were randomly assigned to one of the following three conditions: aerobic exercise training, Zumba dancing, or control. At baseline and 12 weeks later after the end of the intervention, participants' working memory, motor function and depressive symptom severity were assessed.
RESULTS


Working memory, motor function and depressive symptoms improved over time, but only in the aerobic exercise training and Zumba dancing conditions than in the control condition. Post-hoc analyses showed that improvements were greatest among participants assigned to Zumba dancing, followed by participants who engaged in aerobic exercise training; the scores of the control group remained virtually unchanged.
CONCLUSION


Aerobic exercise training and Zumba dancing can be recommended as add-ons to standard care to improve working memory and to reduce severity of depressive symptoms among female patients with FM. Although motor function improved in both intervention groups, the effects did not reach clinical relevance.",2020,"Results:  Working memory, motor function and depressive symptoms improved over time, but only in the aerobic exercise training and Zumba dancing conditions than in the control condition.","['A total of sixty middle-aged female patients with FM (mean age: 35.76 years) and undergoing standard care took part in the study', 'Patients suffering from the Fibromyalgia (FM', 'people with FM', 'female patients with Fibromyalgia', 'female patients with FM']","['Aerobic exercise training and Zumba dancing', 'aerobic exercise training', 'Zumba dancing and aerobic exercise', 'aerobic exercise training, Zumba dancing, or control', 'aerobic exercise training and Zumba dancing']","['working memory, motor function and depressive symptoms', 'Results:  Working memory, motor function and depressive symptoms', 'motor function', 'working memory, motor function and depressive symptom severity', 'working memory, motor function, and depressive symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0664606,"Results:  Working memory, motor function and depressive symptoms improved over time, but only in the aerobic exercise training and Zumba dancing conditions than in the control condition.","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Norouzi', 'Affiliation': 'Department of Human Motor Behavior, Faculty of Sport Science, Urmia University, Urmia, Iran.'}, {'ForeName': 'FatemehSadat', 'Initials': 'F', 'LastName': 'Hosseini', 'Affiliation': 'Department of Human Motor Behavior, Faculty of Sport Science, Urmia University, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Vaezmosavi', 'Affiliation': 'Department of Physical Education, Faculty of Social Science, Imam Hosien University, Tehran, Iran.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, University of Basel, Basel, Switzerland.'}]",European journal of sport science,['10.1080/17461391.2019.1683610']
728,31690402,Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT.,"BACKGROUND


Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection. However, the use of prophylaxis has not been established in myeloma and may be associated with health-care-associated infections (HCAIs), such as  Clostridium difficile . There is a need to assess the benefits and cost-effectiveness of the use of antibacterial prophylaxis against any risks in a double-blind, placebo-controlled, randomised clinical trial.
OBJECTIVES


To assess the risks, benefits and cost-effectiveness of prophylactic levofloxacin in newly diagnosed symptomatic myeloma patients.
DESIGN


Multicentre, randomised, double-blind, placebo-controlled trial. A central telephone randomisation service used a minimisation computer algorithm to allocate treatments in a 1 : 1 ratio.
SETTING


A total of 93 NHS hospitals throughout England, Northern Ireland and Wales.
PARTICIPANTS


A total of 977 patients with newly diagnosed symptomatic myeloma.
INTERVENTION


Patients were randomised to receive levofloxacin or placebo tablets for 12 weeks at the start of antimyeloma treatment. Treatment allocation was blinded and balanced by centre, estimated glomerular filtration rate and intention to give high-dose chemotherapy with autologous stem cell transplantation. Follow-up was at 4-week intervals up to 16 weeks, with a further follow-up at 1 year.
MAIN OUTCOME MEASURES


The primary outcome was to assess the number of febrile episodes (or deaths) in the first 12 weeks from randomisation. Secondary outcomes included number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond.
RESULTS


In total, 977 patients were randomised (levofloxacin,  n  = 489; placebo,  n  = 488). A total of 134 (27%) events (febrile episodes,  n  = 119; deaths,  n  = 15) occurred in the placebo arm and 95 (19%) events (febrile episodes,  n  = 91; deaths,  n  = 4) occurred in the levofloxacin arm; the hazard ratio for time to first event (febrile episode or death) within the first 12 weeks was 0.66 (95% confidence interval 0.51 to 0.86;  p  = 0.002). Levofloxacin also reduced other infections (144 infections from 116 patients) compared with placebo (179 infections from 133 patients;  p -trend of 0.06). There was no difference in new acquisitions of  C. difficile , methicillin-resistant  Staphylococcus aureus  and extended-spectrum beta-lactamase Gram-negative organisms when assessed up to 16 weeks. Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use. With a median follow-up of 52 weeks, there was no significant difference in overall survival ( p  = 0.94).
LIMITATIONS


Short duration of prophylactic antibiotics and cost-effectiveness.
CONCLUSIONS


During the 12 weeks from new diagnosis, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and deaths without increasing HCAIs or carriage. Future work should aim to establish the optimal duration of antibiotic prophylaxis and should involve the laboratory investigation of immunity, inflammation and disease activity on stored samples funded by the TEAMM (Tackling Early Morbidity and Mortality in Myeloma) National Institute for Health Research Efficacy and Mechanism Evaluation grant (reference number 14/24/04).
TRIAL REGISTRATION


Current Controlled Trials ISRCTN51731976.
FUNDING DETAILS


This project was funded by the NIHR Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 62. See the NIHR Journals Library website for further project information.",2019,"Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use.","['newly diagnosed symptomatic myeloma patients', 'A total of 977 patients with newly diagnosed symptomatic myeloma', 'Myeloma', 'A total of 93 NHS hospitals throughout England, Northern Ireland and Wales', 'newly diagnosed symptomatic myeloma', '977 patients were randomised']","['levofloxacin', 'Levofloxacin', 'levofloxacin or placebo tablets', 'levofloxacin,  n \u2009=\u2009489; placebo', 'placebo', 'prophylactic levofloxacin', 'chemotherapy with autologous stem cell transplantation', 'Prophylactic levofloxacin']","['febrile episodes and deaths without increasing HCAIs or carriage', 'new acquisitions of  C. difficile , methicillin-resistant  Staphylococcus aureus  and extended-spectrum beta-lactamase Gram-negative organisms', 'hazard ratio for time to first event (febrile episode or death', 'overall survival', 'quality-adjusted life-year gains', 'number of febrile episodes (or deaths', 'risks, benefits and cost-effectiveness', 'number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0597979', 'cui_str': 'beta-Lactamase'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010187', 'cui_str': 'Cost Benefit'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",977.0,0.673029,"Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use.","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Institute of Infection and Immunity, St George's Hospital, University of London, London, UK.""}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Low', 'Affiliation': 'Patient Advocacy, Myeloma UK, Edinburgh, UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23620']
729,32407786,Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine.,"BACKGROUND


Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora.
OBJECTIVE


To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo.
STUDY DESIGN


In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck, shoulders and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep incisional with or without organ space endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery.
RESULTS


From April 2015 to August 2019, 1356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. A total of 14 patients were lost to follow-up before cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.24). There were no differences in secondary outcomes at 2 or 6 weeks and no differences in primary outcome in a per-protocol analysis.
CONCLUSION


Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.",2020,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"['1,356 patients were enrolled: 682', 'From April 2015 through August 2019', 'Prior to Elective Cesarean Deliveries (STRIPES', 'Fourteen patients were lost to follow-up prior to cesarean delivery (10 in']","['chlorhexidine gluconate-impregnated cloths', 'chlorhexidine and 23 in placebo', 'chlorhexidine', 'Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo', 'chlorhexidine gluconate', 'chlorhexidine and 4 in placebo', 'placebo']","['risk of surgical site infections', 'surgical site infection', 'surgical site infections (superficial or deep -incisional and/or organ space-endometritis', 'surgical site infections by 2 weeks and other wound-related complications', 'Infection', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1356.0,0.327365,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joanne.stone@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Monro', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overybey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cadet', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Katie Hyewon', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pena', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Robles', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Mella', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kathy C', 'Initials': 'KC', 'LastName': 'Matthews', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Factor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.021']
730,30756339,Effect of iloprost inhalation on postoperative outcome in high-risk cardiac surgical patients: a prospective randomized-controlled multicentre trial (ILOCARD).,"PURPOSE


Perioperative right ventricular (RV) failure due to pressure overload from pulmonary hypertension (PH) worsens postoperative outcomes after cardiac surgery. Inhaled iloprost is a potent pulmonary vasodilator improving RV performance, ameliorating myocardial and pulmonary ischemia-reperfusion injury and attenuating inflammation. We hypothesized that the prophylactic inhalation of iloprost would reduce postoperative ventilation times after cardiac surgery.
METHODS


In this phase III, multicentre, randomized, double-blind, placebo-controlled trial, we randomly assigned 253 cardiac surgical patients at high risk of perioperative RV failure to the prophylactic inhalation of 20 µg iloprost or placebo before and during weaning from extracorporeal circulation. The primary endpoint was the duration of postoperative ventilation. Secondary endpoints included perioperative hemodynamics, intensive care unit and hospital length of stay, and 90-day mortality. Safety was assessed by the incidence of adverse events.
RESULTS


Iloprost had no significant effect on the median [interquartile range] duration of postoperative ventilation compared with placebo (720 [470-1170] min vs 778 [541-1219] min, respectively; median decrease, 65 min; 95% confidence interval [CI], - 77 to 210; P = 0.37). While the nebulization of iloprost decreased RV afterload and improved cardiac index, major secondary endpoints were not significantly affected. Ninety-day mortality occurred in 14% of the iloprost patients compared with 14% of the placebo patients (hazard ratio, 0.97; 95% CI, 0.50 to 1.89; P = 0.93). The incidence of adverse events was comparable in both groups.
CONCLUSIONS


The prophylactic inhalation of iloprost did not meaningfully improve the outcome in high-risk cardiac surgical patients.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT00927654); registered 25 June, 2009.",2019,"Inhaled iloprost is a potent pulmonary vasodilator improving RV performance, ameliorating myocardial and pulmonary ischemia-reperfusion injury and attenuating inflammation.","['high-risk cardiac surgical patients', '253 cardiac surgical patients at high risk of perioperative RV failure to the prophylactic inhalation of 20 µg', 'pulmonary hypertension (PH) worsens postoperative outcomes after cardiac surgery', 'before and during weaning from extracorporeal circulation']","['placebo', 'iloprost or placebo', 'iloprost inhalation', 'Inhaled iloprost', 'iloprost']","['RV afterload and improved cardiac index', 'duration of postoperative ventilation', 'postoperative ventilation times', 'postoperative outcome', 'adverse events', 'median [interquartile range] duration of postoperative ventilation', 'Ninety-day mortality', 'perioperative hemodynamics, intensive care unit and hospital length of stay, and 90-day mortality', 'incidence of adverse events', 'Safety']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079594', 'cui_str': 'Iloprost'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",253.0,0.695707,"Inhaled iloprost is a potent pulmonary vasodilator improving RV performance, ameliorating myocardial and pulmonary ischemia-reperfusion injury and attenuating inflammation.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Winterhalter', 'Affiliation': 'Klinik für Anästhesiologie und Schmerztherapie, Klinikum Bremen-Mitte gGmbH, Bremen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Anesthesiology & Department of Cardiovascular Sciences, University Hospitals Leuven, KU Leuven, Herestraat 49, 3000, Leuven, Belgium. steffen.rex@gmail.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stoppe', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsklinikum der RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kienbaum', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hans-Helge', 'Initials': 'HH', 'LastName': 'Müller', 'Affiliation': 'Klinische Forschung, IBE - Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kaufmann', 'Affiliation': 'Klinik für Anästhesiologie, LMU Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Kuppe', 'Affiliation': 'Institut für Anästhesiologie, Deutsches Herzzentrum Berlin, Berlin, Germany.'}, {'ForeName': 'Aristidis', 'Initials': 'A', 'LastName': 'Dongas', 'Affiliation': 'Institut für Anästhesiologie, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Zwissler', 'Affiliation': 'Klinik für Anästhesiologie, LMU Klinikum der Universität München, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01309-8']
731,30745183,Psychoeducational therapy with families of paranoid schizophrenia patients.,"AIM


The study aimed to measure the effectiveness of psychoeducational therapy on the burden of families of paranoid schizophrenia patients.
METHODS


An experimental research design was used in this study with an equivalent control group using 84 random allocation samples at a mental hospital in Semarang. The study instrument was the Indonesian version of the care burden scale (CBS). The Mann-Whitney test was used for the data analysis.
RESULTS


The findings obtained show the effectiveness of psychoeducational therapy on family burden in the experimental group as opposed to standard therapy in the control group (before: Z=-1.27; P=.092, and after: Z=-3.47; P=.002).
CONCLUSION


We conclude that family psychoeducational therapy, as given to the experiment group, can decrease the family burden for the family of a paranoid schizophrenia patient. The application of family psychoeducational therapy can serve as guidance for the psychiatric nurse in reducing the family burden in the care of patients with paranoid schizophrenia.",2020,"The findings obtained show the effectiveness of psychoeducational therapy on family burden in the experimental group as opposed to standard therapy in the control group (before: Z=-1.27; p=.092, and after: Z=-3.47; p=.002).
","['84 random allocation samples at a mental hospital in Semarang', 'patients with paranoid schizophrenia', 'families of paranoid schizophrenia patients']","['Psychoeducational therapy', 'family psychoeducational therapy', 'psychoeducational therapy']",['Indonesian version of the care burden scale (CBS'],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036349', 'cui_str': 'Paranoid Schizophrenia'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0222045'}]",,0.0179497,"The findings obtained show the effectiveness of psychoeducational therapy on family burden in the experimental group as opposed to standard therapy in the control group (before: Z=-1.27; p=.092, and after: Z=-3.47; p=.002).
","[{'ForeName': 'Mohammad Fatkhul', 'Initials': 'MF', 'LastName': 'Mubin', 'Affiliation': 'Department of Psychiatric Nursing, Nursing Faculty, Universitas Muhammadiyah Semarang, Semarang, Indonesia. Electronic address: fati_942000@yahoo.com.'}, {'ForeName': 'Ignatius', 'Initials': 'I', 'LastName': 'Riwanto', 'Affiliation': 'Department of Medical Surgeries, Medicine Faculty, Universitas Diponegoro, Semarang, Indonesia. Electronic address: iriwanto@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Soewadi', 'Affiliation': 'Department of Psychiatriy, Medicine Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia. Electronic address: profesorsoewadi@yahoo.co.id.'}, {'ForeName': 'Hastaning', 'Initials': 'H', 'LastName': 'Sakti', 'Affiliation': 'Faculty of Psychology, Universitas Diponegoro, Semarang, Indonesia. Electronic address: sakti.hasta@gmail.com.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Erawati', 'Affiliation': 'Department of Mental Health Nursing, Poltekkes Kemenkes Semarang, Prodi Keperawatan Magelang, Kota Magelang, Indonesia. Electronic address: ernaerawati57@yahoo.com.'}]",Enfermeria clinica,['10.1016/j.enfcli.2018.12.006']
732,27720537,Mortality Among Men with Advanced Prostate Cancer Excluded from the ProtecT Trial.,"BACKGROUND


Early detection and treatment of asymptomatic men with advanced and high-risk prostate cancer (PCa) may improve survival rates.
OBJECTIVE


To determine outcomes for men diagnosed with advanced PCa following prostate-specific antigen (PSA) testing who were excluded from the ProtecT randomised trial.
DESIGN, SETTING, AND PARTICIPANTS


Mortality was compared for 492 men followed up for a median of 7.4 yr to a contemporaneous cohort of men from the UK Anglia Cancer Network (ACN) and with a matched subset from the ACN.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


PCa-specific and all-cause mortality were compared using Kaplan-Meier analysis and Cox's proportional hazards regression.
RESULTS AND LIMITATIONS


Of the 492 men excluded from the ProtecT cohort, 37 (8%) had metastases (N1, M0=5, M1=32) and 305 had locally advanced disease (62%). The median PSA was 17μg/l. Treatments included radical prostatectomy (RP; n=54; 11%), radiotherapy (RT; n=245; 50%), androgen deprivation therapy (ADT; n=122; 25%), other treatments (n=11; 2%), and unknown (n=60; 12%). There were 49 PCa-specific deaths (10%), of whom 14 men had received radical treatment (5%); and 129 all-cause deaths (26%). In matched ProtecT and ACN cohorts, 37 (9%) and 64 (16%), respectively, died of PCa, while 89 (22%) and 103 (26%) died of all causes. ProtecT men had a 45% lower risk of death from PCa compared to matched cases (hazard ratio 0.55, 95% confidence interval 0.38-0.83; p=0.0037), but mortality was similar in those treated radically. The nonrandomised design is a limitation.
CONCLUSIONS


Men with PSA-detected advanced PCa excluded from ProtecT and treated radically had low rates of PCa death at 7.4-yr follow-up. Among men who underwent nonradical treatment, the ProtecT group had a lower rate of PCa death. Early detection through PSA testing, leadtime bias, and group heterogeneity are possible factors in this finding.
PATIENT SUMMARY


Prostate cancer that has spread outside the prostate gland without causing symptoms can be detected via prostate-specific antigen testing and treated, leading to low rates of death from this disease.",2017,"ProtecT men had a 45% lower risk of death from PCa compared to matched cases (hazard ratio 0.55, 95% confidence interval 0.38-0.83; p=0.0037), but mortality was similar in those treated radically.","['Of the 492 men excluded from the ProtecT cohort, 37 (8%) had metastases (N1, M0=5, M1=32) and 305 had locally advanced disease (62', 'asymptomatic men with advanced and high-risk prostate cancer (PCa', 'Men with Advanced Prostate Cancer Excluded from the ProtecT Trial', '492 men followed up for a median of 7.4 yr to a contemporaneous cohort of men from the UK Anglia Cancer Network (ACN) and with a matched subset from the ACN', 'men diagnosed with advanced PCa following prostate-specific antigen (PSA) testing who were excluded from the ProtecT randomised trial', 'ADT; n=122; 25%), other treatments (n=11; 2%), and unknown (n=60; 12']","['androgen deprivation therapy', 'radical prostatectomy', 'radiotherapy']","['Mortality', 'survival rates', '49 PCa-specific deaths', 'risk of death from PCa', 'died of PCa', 'median PSA', 'PCa-specific and all-cause mortality', 'PCa death', 'mortality', 'rate of PCa death']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0249643', 'cui_str': 'ACN'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.42404,"ProtecT men had a 45% lower risk of death from PCa compared to matched cases (hazard ratio 0.55, 95% confidence interval 0.38-0.83; p=0.0037), but mortality was similar in those treated radically.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Johnston', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. Electronic address: thomasjohnston1@nhs.net.'}, {'ForeName': 'Greg L', 'Initials': 'GL', 'LastName': 'Shaw', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK; Cancer Research UK Cambridge Institute, Li Ka Shing Centre, Cambridge, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Lamb', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK; Cancer Research UK Cambridge Institute, Li Ka Shing Centre, Cambridge, UK.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Parashar', 'Affiliation': 'Statistics and Epidemiology Unit & Cancer Research Centre, University of Warwick, Coventry, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'National Cancer Registration Service - Eastern Office, Public Health England, Cambridge, UK.'}, {'ForeName': 'Tengbin', 'Initials': 'T', 'LastName': 'Xiong', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Herbert', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mizielinsk', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Doble', 'Affiliation': ""Department of Urology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Prescott', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Powell', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rosario', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. Electronic address: den22@cam.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2016.09.040']
733,30501915,Olive leaf tea may have hematological health benefit over green tea.,"Olive leaf extracts are rich in several polyphenols having potential health benefits. We conducted the current parallel-group randomized controlled trial to compare the effects of long-term consumption of olive leaf tea (OLT) and green tea (GT) on hematological parameters in 31 female volunteers aged between 40 and 70 years of old. We found that RBC count, hemoglobin, and hematocrit were increased significantly in the OLT group than those of in the GT group at 6 and 12 weeks of intervention. Within-group comparison showed that hematocrit was significantly increased in the OLT group at 6 weeks of intervention, whereas RBC count and serum iron was significantly decreased in the GT group at 12 weeks of intervention. This is the first clinical study reporting the beneficial effects of continuous intake of OLT on hematological parameters. This observation is supported by our previous in vitro study reporting the differentiation-inducing effect of certain olive leaf components on human hematopoietic stem cells. However, further investigations in larger cohorts with a careful consideration of target population are required to confirm the preventive effect of OLT against anemia and other red cell disorders.",2019,"We found that RBC count, hemoglobin, and hematocrit were increased significantly in the OLT group than those of in the GT group at 6 and 12 weeks of intervention.",['31 female volunteers aged between 40 and 70 years of old'],"['long-term consumption of olive leaf tea (OLT) and green tea (GT', 'Olive leaf tea', 'OLT']","['hematocrit', 'RBC count and serum iron', 'RBC count, hemoglobin, and hematocrit']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0228539', 'cui_str': 'Nucleus Basalis, Olivary'}, {'cui': 'C0242724', 'cui_str': 'Plant Leaves'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}]","[{'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0014772', 'cui_str': 'Erythrocyte Number'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",31.0,0.0192643,"We found that RBC count, hemoglobin, and hematocrit were increased significantly in the OLT group than those of in the GT group at 6 and 12 weeks of intervention.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferdousi', 'Affiliation': 'Alliance for Research on the Mediterranean and North Africa (ARENA), University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Araki', 'Affiliation': 'Course of Clinical Research and Regional Innovation Donated by the Japanese Agriculture Ibaraki Public Welfare Federation, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Course of Clinical Research and Regional Innovation Donated by the Japanese Agriculture Ibaraki Public Welfare Federation, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'Alliance for Research on the Mediterranean and North Africa (ARENA), University of Tsukuba, Tsukuba, Japan; Faculty of Life and Environmental Sciences, University of Tsukuba, Tsukuba, Japan. Electronic address: isoda.hiroko.ga@u.tsukuba.ac.jp.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.009']
734,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
735,30458655,Citrulline Malate Fails to Improve German Volume Training Performance in Healthy Young Men and Women.,"Citrulline malate (CM) is purported to buffer lactic acid, enhance oxygen delivery, and attenuate muscle soreness. Anaerobic exercise trials with CM have produced conflicting results. The aim of the current investigation was to test the efficacy of CM on resistance training (RT) with the hypothesis that CM would improve performance. A double-blind, counter-balanced, randomized control trial was utilized to assess the effects of CM on RT. Nineteen participants (8 female) (25.7 ± 7.7 years), regularly engaged in RT, consumed either 8 g of CM (1.1:1 ratio) or a placebo (6 g citric acid). Participants attempted to perform a German Volume Training (GVT) protocol comprising 10 sets of 10 repetitions of barbell curls at 80% of their one repetition maximum. Repeated ANOVA suggested no effect of CM on RT performance (treatment × time × order  p  = .217). There was no difference ( p  = .320) in the total number of reps over the 10 sets (CM median = 57, IQR 45-73; placebo median = 61, IQR 51-69). Blood lactate and creatine kinase did not differ between CM and placebo ( p  > .05). Finally, total muscle soreness was reduced significantly in CM compared to placebo (treatment × time × order  p  = .004). These results require corroboration; an ergogenic benefit is yet to be established, and weight trainers should exercise caution when assessing the efficacy of CM. Future research should focus on the potential effects of loading doses of CM.",2020,"Finally, total muscle soreness was reduced significantly in CM compared to placebo (treatment × time × order p = .004).","['Nineteen participants (8 female) (25.7\u2009±\u20097.7\u2009years), regularly engaged in RT, consumed either 8\u2009g of CM (1.1:1 ratio) or a', 'Healthy Young Men and Women']","['Citrulline Malate', 'placebo', 'Citrulline malate (CM', 'placebo (6\u2009g citric acid', 'German Volume Training (GVT) protocol']","['total muscle soreness', 'total number of reps', 'Blood lactate and creatine kinase', 'RT performance']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0109943', 'cui_str': 'citrulline malate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}]",,0.272325,"Finally, total muscle soreness was reduced significantly in CM compared to placebo (treatment × time × order p = .004).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Chappell', 'Affiliation': 'Food and Nutrition Group, Sheffield School of Business, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Allwood', 'Affiliation': 'Department of Biosciences and Chemistry, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Trevor N', 'Initials': 'TN', 'LastName': 'Simper', 'Affiliation': 'Food and Nutrition Group, Sheffield School of Business, Sheffield Hallam University, Sheffield, UK.'}]",Journal of dietary supplements,['10.1080/19390211.2018.1513433']
736,32107315,Effectiveness of modified complex decongestive physiotherapy for preventing lower extremity lymphedema after radical surgery for cervical cancer: a randomized controlled trial.,"BACKGROUND


There is a lack of evidence in support of any prophylactic measure to prevent secondary lower extremity lymphedema after radical hysterectomy among patients with cervical cancer. This study aimed to determine the effectiveness of modified complex decongestive physiotherapy in reducing the risk of secondary lower extremity lymphedema after radical surgery.
METHODS


A randomized single-blind clinical trial was conducted in 120 patients with cervical cancer who underwent laparoscopic radical hysterectomy with pelvic lymphadenectomy between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China. Participants were randomly assigned to a modified complex decongestive physiotherapy intervention group (n=60) or control group (n=60). The intervention group received a modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education. The control group only received a health education program. The main outcome was the incidence of secondary lower extremity lymphedema.
RESULTS


A total of 117 patients with cervical cancer completed a 1-year follow-up. Twenty-eight (23.9%) patients developed secondary lower extremity lymphedema (20 (34.5%) patients in the control group and 8 (13.6%) in the intervention group). The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30 (95% CI 0.12 to 0.75). The median percentage of excess volume was significantly less in the intervention group (2.1%, IQR 0.5-3.4%) than in the control group (2.96%, IQR 1.1-4.98%); (p = 0.042). The mean (SD) onset time of lymphedema was 8 (2.00) months vs 4.6 (2.82) months in the intervention and control groups, respectively (p=0.004).
CONCLUSIONS


This randomized trial showed that modified complex decongestive physiotherapy is effective for preventing lower extremity lymphedema in patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy.",2020,The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30,"['lower extremity lymphedema after radical surgery for cervical cancer', '120 patients with cervical cancer who underwent', 'patients with cervical cancer after laparoscopic radical hysterectomy with pelvic lymphadenectomy', 'patients with cervical cancer', 'between January 2016 and April 2017 in the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China', '117 patients with cervical cancer completed a 1-year follow-up']","['radical hysterectomy', 'modified complex decongestive physiotherapy', 'modified complex decongestive physiotherapy program, which included manual lymph drainage, compression hosiery, regular exercise, and health education', 'modified complex decongestive physiotherapy intervention group (n=60) or control group', 'health education program', 'laparoscopic radical hysterectomy with pelvic lymphadenectomy']","['extremity lymphedema', 'mean (SD) onset time of lymphedema', 'incidence of secondary lower extremity lymphedema', 'secondary lower extremity lymphedema', 'median percentage of excess volume']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy (procedure)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0453907', 'cui_str': 'Hosiery (physical object)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0018701'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0404093', 'cui_str': 'Laparoscopic radical hysterectomy (procedure)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",120.0,0.0627603,The incidence of secondary lower extremity lymphedema was significantly higher in the control group than in the intervention group (p=0.008; OR 0.30,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Nursing, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China jonish@vip.sina.com.'}, {'ForeName': 'Hui-Yuan', 'Initials': 'HY', 'LastName': 'Cai', 'Affiliation': 'Department of Lymphedema Rehabilitation Clinic, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Fang-Qin', 'Initials': 'FQ', 'LastName': 'Fan', 'Affiliation': 'Department of Lymphedema Rehabilitation Clinic, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'An', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000911']
737,30887868,"A Double-Blind, Cross-Over Study to Examine the Effects of Maritime Pine Extract on Exercise Performance and Postexercise Inflammation, Oxidative Stress, Muscle Soreness, and Damage.","The purpose of the present study was to examine whether 14 days of supplementation with maritime pine extract leading up to and following an exercise test would increase performance and reduce biomarkers associated with muscle damage, inflammation, and oxidative stress. The study used a double-blind, placebo-controlled, cross-over design. Twenty apparently healthy young male participants ingested either 800 mg pine bark extract or placebo for 14 days prior to the first exercise trial and for 2 days postexercise. On the exercise day, participants submitted a pre-exercise blood sample then completed a VO 2  peak test until volitional failure. A postexercise blood sample was collected 1 hour after completion of exercise. Participants returned at 24 and 48 hours after the exercise testing for measures of muscle pain in the lower body using an algometer. Participants then had a 7-day washout period before beginning to cross over to the alternate treatment. Analysis via ordinal regression demonstrated a significant difference in oxidative stress in the maritime pine extract group compared to placebo (ChiSq = 2.63;  p  = 0.045). Maritime pine extract was effective at affording protection from oxidative stress postexercise. Further work should be undertaken to evaluate the findings with other exercise modes or in participants with known metabolic syndrome.",2020,Analysis via ordinal regression demonstrated a significant difference in oxidative stress in the maritime pine extract group compared to placebo (ChiSq = 2.63; p = 0.045).,"['Twenty apparently healthy young male participants', 'participants with known metabolic syndrome']","['placebo', 'Maritime Pine Extract', '800\u2009mg pine bark extract or placebo']","['oxidative stress', 'muscle damage, inflammation, and oxidative stress', 'Exercise Performance and Postexercise Inflammation, Oxidative Stress, Muscle Soreness, and Damage', 'muscle pain']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3255957', 'cui_str': 'Maritime Pine extract'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0872909', 'cui_str': 'pine bark extract'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",20.0,0.265868,Analysis via ordinal regression demonstrated a significant difference in oxidative stress in the maritime pine extract group compared to placebo (ChiSq = 2.63; p = 0.045).,"[{'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Aldret', 'Affiliation': 'School of Kinesiology, University of Louisiana at Lafayette, Lafayette, LA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellar', 'Affiliation': 'School of Kinesiology, University of Louisiana at Lafayette, Lafayette, LA, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1578847']
738,30496532,"Examining the external validity of the CRUZA study, a randomized trial to promote implementation of evidence-based cancer control programs by faith-based organizations.","The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control. This paper examines the external generalizability of the CRUZA study findings by comparing characteristics of parishes that agreed to participate in the intervention trial versus those that declined participation. Sixty-five Roman Catholic parishes that offered Spanish-language mass in Massachusetts were invited to complete a four-part survey assessing organization-level characteristics that, based on the Consolidated Framework for Implementation Research (CFIR), may be associated with EBI implementation. Forty-nine parishes (75%) completed the survey and were invited to participate in the CRUZA trial, which randomized parishes to either a ""capacity enhancement intervention"" or a ""standard dissemination"" group. Of these 49 parishes, 31 (63%) agreed to participate in the trial, whereas 18 parishes (37%) declined participation. Parishes that participated in the CRUZA intervention trial were similar to those that did not participate with respect to ""inner organizational setting"" characteristics of the CFIR, including innovation and values fit, implementation climate, and organizational culture. Change commitment, a submeasure of organizational readiness that reflects the shared resolve of organizational members to implement an innovation, was significantly higher among the participating parishes (mean = 3.93, SD = 1.08) as compared to nonparticipating parishes (mean = 3.27, SD = 1.08) (Z = -2.16, p = .03). Parishes that agreed to participate in the CRUZA intervention trial were similar to those that declined participation with regard to organizational characteristics that may predict implementation of EBIs. Pragmatic tools to assess external generalizability in community-based implementation trials and to promote readiness among faith-based organizations to implement EBIs are needed to enhance the reach and impact of public health research. Clinical Trial information: The CRUZA trial identifier number with clinicaltrials.gov is NCT01740219.",2020,The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control.,"['Forty-nine parishes (75%) completed the survey and were invited to participate in the CRUZA trial', 'Sixty-five Roman Catholic parishes that offered Spanish-language mass in Massachusetts']","['organizational-level intervention', 'capacity enhancement intervention"" or a ""standard dissemination"" group']",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholics'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0538825,The CRUZA trial tested the efficacy of an organizational-level intervention to increase capacity among Catholic parishes to implement evidence-based interventions (EBIs) for cancer control.,"[{'ForeName': 'Jennifer Dacey', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Kephart', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Tom', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Leyva', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Hosffman', 'Initials': 'H', 'LastName': 'Ospino', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}, {'ForeName': 'Adolfo G', 'Initials': 'AG', 'LastName': 'Cuevas', 'Affiliation': 'Community Health, Tufts University, Medford, MA.'}]",Translational behavioral medicine,['10.1093/tbm/iby099']
739,30665815,Development and Prospective Randomized Evaluation of a Decision Aid for Prostate-specific Antigen-based Early Detection of Prostate Cancer in Men Aged Between 55 and 69Yr: The PSAInForm Trial.,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.",2019,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.",['Men Aged Between 55 and 69Yr'],['Decision Aid for Prostate-specific Antigen-based Early Detection of Prostate Cancer'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],,0.0471366,"For men interested in early detection of prostate cancer, the potential impact on decisional conflict of a decision aid with or without cost compensation for the prostate-specific antigen test will be investigated.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Semjonow', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany. Electronic address: semjono@uni-muenster.de.'}, {'ForeName': 'Hans-Werner', 'Initials': 'HW', 'LastName': 'Hense', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schlößler', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Simbrich', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Borowski', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Bothe', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kruse', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Tiedje', 'Affiliation': 'Prostate Center, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuss', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Charles Christian', 'Initials': 'CC', 'LastName': 'Adarkwah', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany; Department of Health Services Research and General Practice, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Maisel', 'Affiliation': 'Department of General Medicine, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Jendyk', 'Affiliation': 'Department of General Medicine, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Kurosinski', 'Affiliation': 'Institute of Epidemiology and Social Medicine, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerß', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfalian Wilhelms-University Muenster, Muenster, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Heidinger', 'Affiliation': 'Cancer Registry of North Rhine-Westphalia, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tschuschke', 'Affiliation': 'Berufsverband der Deutschen Urologen, Landesverband Westfalen-Lippe, Muenster, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Becker', 'Affiliation': 'Hausaerzteverbund Muenster, Muenster, Germany.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus University Medical Center, Erasmus University Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus University Medical Center, Erasmus University Rotterdam, The Netherlands.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhoff', 'Affiliation': 'Department of General Practice/Family Medicine University of Marburg, Philipps-University Marburg, Marburg, Germany.'}]",European urology,['10.1016/j.eururo.2019.01.008']
740,30687808,Randomised trial of two embolic agents for uterine artery embolisation for fibroids: Gelfoam versus Embospheres (RAGE trial).,"Background


Uterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.
Methods


We conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months.
Results


Twenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 ( p  = 0.001) and from 1026 ± 756 to 908 ± 720 ( p  = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter  p  = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.
Conclusion


The only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.
Trial registration


ISRCTN67347987.",2019,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","['women with symptomatic uterine fibroids who wish to avoid surgery', 'uterine artery embolisation for fibroids', 'Twenty patients', 'women undergoing UAE']","['embolic agents', 'Gelfoam (G) or Embospheres (E', 'Gelfoam with Embospheres', '\n\n\nUterine artery embolisation (UAE']","['Uterine volume', 'complications, inflammatory, haematological markers and ovarian function', 'quality of life (UFS-Qol', 'Contrast enhanced MRI (CEMRI', 'UFS-Qol HRQL', 'UFS-Qol symptom score', 'uterine volume', 'Pain score (visual analogue', 'fibroid infarction rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C1566002', 'cui_str': 'Embospheres'}, {'cui': 'C0226378', 'cui_str': 'Uterine Artery'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]",20.0,0.257914,"UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yadavali', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ananthakrishnan', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': '6Radiology department, Gartnavel General Hospital, 1053 Great Western Rd, Glasgow, G12 OYN UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Monaghan', 'Affiliation': '2School of Mathematics and Statistics, University of Glasgow, Glasgow, G12 8QW UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McNaught', 'Affiliation': ""3Clinical Research Imaging Centre, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hamoodi', 'Affiliation': 'University Department of Obstetrics and Gynaecology, Glasgow, New Lister Building, 10-16 Alexandra Parade, Glasgow, G31 2ER UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bryden', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lassman', 'Affiliation': 'Radiology department, Stobhill ACH Hospital, 133 Balornock Road, Glasgow, G21 3UW UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Moss', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, 126 University Place, Glasgow, G12 8TA UK.'}]",CVIR endovascular,['10.1186/s42155-018-0044-y']
741,30887927,"Dietary Adherence, Self-Efficacy, and Health Behavior Change of WASHOKU-Modified DASH Diet: A Sub-analysis of the DASH-JUMP Study.","BACKGROUND


We previously reported the nutritional characteristics and effects of the DASH-JUMP diet, which is a WASHOKU-modified DASH diet, in Japanese participants with untreated high-normal blood pressure or stage 1 hypertension. The dietary adherence of the DASH diet in Japanese participants has never been evaluated before.
OBJECTIVE


We aimed to assess the relationships between dietary adherence, self-efficacy, and health behavior change among study participants who received the DASH-JUMP diet by home delivery.
METHODS


Participants were treated with the DASH-JUMP diet for 2 months and consumed their usual diets for the next 4 months. We conducted surveys using the stage of behavior change model questionnaire and the modified perceived health competence scale Japanese version questionnaire at baseline and 1, 2, 3, and 6 months to assess dietary adherence.
RESULTS


Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years) returned completed questionnaires, which we analyzed. Health behavior change was motivated by previous behavioral changes and improved biomarkers. The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy. The experience of the DASH-JUMP study for participants included three processes to improve lifestyle habits: Phase 1, reflecting on previous lifestyle habits; Phase 2, learning through new experiences and the acquisition of knowledge; and Phase 3, desiring to maintain their own health.
CONCLUSION


It indicated that the DASH-JUMP diet significantly increased self-efficacy and promoted health behavior change.",2020,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"['Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years', 'Japanese participants with untreated high-normal blood pressure or stage 1 hypertension', 'Japanese participants', 'Participants were treated with the', 'study participants who received the DASH-JUMP diet by home delivery']","['DASH-JUMP diet', 'modified DASH Diet', 'DASH diet']","['health behavior change and previous self-efficacy', 'improvement and maintenance of self-efficacy', 'health competence scale Japanese version questionnaire', 'Dietary Adherence, Self-Efficacy, and Health Behavior Change', 'self-efficacy and promoted health behavior change', 'dietary adherence, self-efficacy, and health behavior change']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.019028,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Inagaki', 'Affiliation': 'Faculty of Nursing Science, Yamanashi Prefectural University, Kouhu, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Umemoto', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kajiya', 'Affiliation': 'Department of Food Science and Biotechnology, Faculty of Agriculture, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kishi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mitarai', 'Affiliation': 'Central Research Institute, Maruha Nichiro Corporation, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Current hypertension reviews,['10.2174/1573402115666190318125006']
742,30482089,A pilot study on the impact of a pottery workshop on the well-being of people with dementia.,"OBJECTIVE


This study seeks to assess the impact of a pottery workshop as a creative arts programme and discover the extent to which people with dementia taking part in an artistic and creative activity engage with it, experience a feeling of well-being, and improve their mood state. In addition, the study will seek to answer the question of whether taking part in a programme of creative activities improves the self-esteem of people with dementia.
METHOD


The research used an uncontrolled, repeated measures design. Thirty users of the National Reference Centre for Alzheimer's and Dementia care in Salamanca (Spain) in a moderate to advanced stage of dementia (Global Deterioration Scale 4, 5, or 6) were divided into five intervention groups that received ten 45-minute sessions in which they were helped by facilitators to make different ceramic pieces. The participants were assessed before and after the intervention with a self-esteem scale, and they rated their mood before and after the sessions on a graphic scale. During the art sessions, two observers recorded the presence of multiple indicators of well-being.
RESULTS


The intervention was found to have a significant impact on mood and self-esteem that was independent of the participants' Global Deterioration Scale. Regarding the tool used to observe well-being, the participants scored highly in the domains of sustained attention, pleasure, self-esteem, and normalcy, with low scores in negative affect and sadness.
CONCLUSIONS


Pottery may be a highly suitable activity for people with dementia, as they may enjoy both the activity and the creative process, with it triggering a positive mood during the sessions, providing psychological well-being and reinforcing their self-esteem.",2020,The intervention was found to have a significant impact on mood and self-esteem that was independent of the participants' Global Deterioration Scale.,"['people with dementia', ""Thirty users of the National Reference Centre for Alzheimer's and Dementia care in Salamanca (Spain) in a moderate to advanced stage of dementia""]",['pottery workshop'],"['Global Deterioration Scale', 'mood and self-esteem']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.0501705,The intervention was found to have a significant impact on mood and self-esteem that was independent of the participants' Global Deterioration Scale.,"[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Pérez-Sáez', 'Affiliation': 'Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, España.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Cabrero-Montes', 'Affiliation': 'Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, España.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Llorente-Cano', 'Affiliation': 'Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, España.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González-Ingelmo', 'Affiliation': 'Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso, España.'}]","Dementia (London, England)",['10.1177/1471301218814634']
743,30597550,The Developmental Sequence and Relations Between Gesture and Spoken Language in Toddlers With Autism Spectrum Disorder.,"In typical development, gestures precede and predict language development. This study examines the developmental sequence of expressive communication and relations between specific gestural and language milestones in toddlers with autism spectrum disorder (ASD), who demonstrate marked difficulty with gesture production and language. Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations) were assessed monthly by blind raters for toddlers with ASD participating in an randomized control trial of parent-mediated treatment (N = 42, 12-30 months). Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.",2020,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","['Toddlers With Autism Spectrum Disorder', 'toddlers with autism spectrum disorder (ASD']",[],"['Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]",[],"[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]",,0.0214743,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","[{'ForeName': 'Meagan R', 'Initials': 'MR', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Young', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis.'}]",Child development,['10.1111/cdev.13203']
744,30629160,Targeted therapy of underlying conditions improves quality of life in patients with persistent atrial fibrillation: results of the RACE 3 study.,"AIMS


Atrial fibrillation (AF) reduces quality of life (QoL). We aim to evaluate effects of targeted therapy of underlying conditions on QoL in patients with AF and heart failure (HF).
METHODS AND RESULTS


The Routine versus Aggressive risk factor driven upstream rhythm Control for prevention of Early atrial fibrillation in heart failure (RACE 3) study randomized patients with early persistent AF and HF to targeted or conventional therapy. Both groups received guideline-driven treatment. The targeted group received four additional therapies: mineralocorticoid receptor antagonists; statins; angiotensin converting enzyme inhibitors and/or receptor blockers; and cardiac rehabilitation including physical activity, dietary restrictions, and counselling. Quality of life was analysed in 230 patients at baseline and 1 year with available Medical Outcomes Study Short-Form Health Survey (SF-36), University of Toronto AF Severity Scale (AFSS) questionnaires, and European Heart Rhythm Association (EHRA) class. Improvements in SF-36 subscales were larger in the targeted group for physical functioning (Δ12 ± 19 vs. Δ6 ± 22, P = 0.007), physical role limitations (Δ32 ± 41 vs. Δ17 ± 45, P = 0.018), and general health (Δ8 ± 16 vs. Δ0 ± 17, P < 0.001). Dyspnoea at rest improved more (Δ-0.8 ± 1.3 vs. Δ-0.4 ± 1.2, P = 0.018) and EHRA class was lower at 1-year follow-up in the targeted group. Patients with AF at 1 year, improvement in physical functioning (Δ9 ± 9 vs. Δ-3 ± 16, P = 0.001), general health (Δ7 ± 16 vs. Δ-7 ± 19, P = 0.004), and social functioning (Δ6 ± 23 vs. Δ-4 ± 16, P = 0.041) were larger in the targeted group.
CONCLUSION


A strategy aiming to treat underlying conditions improved QoL more compared with conventional therapy in patients with early persistent AF and HF. Its benefit was even observed in patients in AF at 1 year.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov NCT00877643.",2019,"Improvements in SF-36 subscales were larger in the targeted group for physical functioning (Δ12 ± 19 vs. Δ6 ± 22, P = 0.007), physical role limitations (Δ32 ± 41 vs. Δ17 ± 45, P = 0.018), and general health (Δ8 ± 16 vs. Δ0 ± 17, P < 0.001).","['230 patients at baseline and 1 year with available Medical Outcomes Study', 'patients with AF and heart failure (HF', 'patients with early persistent AF and HF', 'heart failure (RACE 3) study randomized patients with early persistent AF and HF to targeted or conventional therapy', 'patients with persistent atrial fibrillation']","['conventional therapy', 'Routine versus Aggressive risk factor driven upstream rhythm Control', 'four additional therapies: mineralocorticoid receptor antagonists; statins; angiotensin converting enzyme inhibitors and/or receptor blockers; and cardiac rehabilitation including physical activity, dietary restrictions, and counselling', 'guideline-driven treatment']","['Quality of life', 'SF-36 subscales', 'social functioning', 'Short-Form Health Survey (SF-36), University of Toronto AF Severity Scale (AFSS) questionnaires, and European Heart Rhythm Association (EHRA) class', 'quality of life', 'general health', 'quality of life (QoL', 'physical role limitations', 'EHRA class', 'physical functioning', 'Dyspnoea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0522505', 'cui_str': 'Upstream (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",,0.0553524,"Improvements in SF-36 subscales were larger in the targeted group for physical functioning (Δ12 ± 19 vs. Δ6 ± 22, P = 0.007), physical role limitations (Δ32 ± 41 vs. Δ17 ± 45, P = 0.018), and general health (Δ8 ± 16 vs. Δ0 ± 17, P < 0.001).","[{'ForeName': 'Ruben R', 'Initials': 'RR', 'LastName': 'De With', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Marcelle D', 'Initials': 'MD', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Weijs', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Zwartkruis', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Hobbelt', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Department of Cardiology, Amphia Hospital Breda, Julius Clinical, Zeist, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brügemann', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Geelhoed', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Hillege', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tukkie', 'Affiliation': 'Department of Cardiology, Spaarne Hospital, Haarlem, The Netherlands.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Hemels', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital Arnhem, and Department of Cardiology, Radboud University Medical Centre Nijmegen, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Adelita V', 'Initials': 'AV', 'LastName': 'Ranchor', 'Affiliation': 'Department of Health Psychology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre+, Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, RB Groningen, Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy311']
745,30399021,Serum Concentrations of Lidocaine During Bariatric Surgery.,"Lidocaine has been shown to be clinically beneficial during bariatric surgery. However, information about lidocaine serum concentrations in this setting is scarce. This prospective clinical trial included 42 obese patients undergoing laparoscopic bariatric surgery. They received lidocaine based on adjusted body weight. Administration began with a 1.5 mg·kg bolus of intravenous lidocaine followed by a continuous infusion of 2 mg·kg·hour. After skin closure, administration was decreased to 1 mg·kg·hour until discharge from the recovery room. No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).",2020,No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).,['42 obese patients undergoing'],"['lidocaine', 'laparoscopic bariatric surgery', 'Lidocaine']","['serum concentrations', 'Serum Concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",42.0,0.0631588,No serum concentrations of lidocaine were outside the usual accepted range (1.5-5 µg·mL).,"[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Carabalona', 'Affiliation': 'From the *Département d\'Anesthésie-Réanimation, Groupement Hospitalier Édouard Herriot, Hospices Civils de Lyon, Lyon, France †Equipe d\'Accueil 7426 ""Pathophysiology of Injury-Induced Immunosuppression"" Hospices Civils de Lyon - bioMérieux - Université Claude Bernard Lyon 1, Lyon, France ‡Pôle de Santé publique, Hospices Civils de Lyon, F-69003 Lyon, France §Health Services and Performance Research Laboratory, HEalth Services and PERformance Research Equipe d\'Accueil 7425, Université Claude Bernard Lyon 1, F-69008 Lyon, France ‖Laboratoire de Biologie Médicale Multi Sites du Centre Hospitalo-Universitaire de Lyon, unité de Pharmacologie, Toxicologie et Eléments trace, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon, Lyon, France ¶Laboratoire de Biologie Médicale Multi Sites du Centre Hospitalo-Universitaire de Lyon, unité de Pharmacologie, Toxicologie et Eléments trace, Groupement Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Delwarde', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': ''}, {'ForeName': 'Mary-Charlotte', 'Initials': 'MC', 'LastName': 'Le Goff', 'Affiliation': ''}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Moulsma', 'Affiliation': ''}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Citterio-Quentin', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bouffard', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003905']
746,30638635,"Feasibility, Acceptability, and Behavioral Outcomes from a Technology-enhanced Behavioral Change Intervention (Prostate 8): A Pilot Randomized Controlled Trial in Men with Prostate Cancer.","BACKGROUND


Increasing evidence suggests that lifestyle factors may decrease the risk of prostate cancer progression. Lifestyle guidelines and tools may support lifestyle modification after diagnosis.
OBJECTIVE


To determine the feasibility and acceptability of a digital lifestyle intervention among men with prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS


A 12-wk pilot randomized controlled trial among 76 men with clinical stage T1-T3a prostate cancer. Eligibility included Internet access, no contraindications to aerobic exercise, and engaging in four or fewer of eight targeted behaviors at baseline.
INTERVENTION


Website, Fitbit One, and text messaging to facilitate adoption of eight behaviors: vigorous activity, smoking cessation, and six diet improvements.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Our primary outcomes were feasibility and acceptability based on recruitment and user data, and surveys, respectively. Secondarily, we evaluated the change in eight lifestyle behaviors, and also objective physical activity. Each factor was assigned one point, for an overall ""P8 score"" (range 0-8). Analysis of covariance (ANCOVA) was conducted. Exploratory outcomes included quality of life, anthropometrics, and circulating biomarkers after 12wk, and behaviors after 1yr.
RESULTS AND LIMITATIONS


At baseline, men in both arms met a median of three targeted behaviors. Sixty-four men (n=32 per arm) completed the study; 88% completed 12-wk assessments (intervention, 94%; control, 82%). Intervention participants wore their Fitbits a median of 82d (interquartile range [IQR]: 72-83), replied to a median of 71% of text messages (IQR: 57-89%), and visited the website a median of 3d (IQR: 2-5) over 12wk. Median (IQR) absolute changes in the P8 score from baseline to 12wk were 2 (1, 3) for the intervention and 0 (-1, 1) for the control arm. The estimated mean score of the intervention arm was 1.5 (95% confidence interval: 0.7, 2.3) higher than that of the control arm at 12wk (ANCOVA p<0.001). Changes were driven by diet rather than exercise. Limitations include self-reported diet and exercise data.
CONCLUSIONS


Overall, in this novel pilot trial, the intervention was feasible and acceptable to men with prostate cancer. Next steps include improving the intervention to better meet individuals' needs and focusing on increasing physical activity in men not meeting nationally recommended physical activity levels.
PATIENT SUMMARY


Tailored print materials combined with technology integration, including the use of a website, text messaging, and physical activity trackers, helped men with prostate cancer adopt healthy lifestyle habits, in particular recommended dietary changes, in the Prostate 8 pilot trial.",2019,The estimated mean score of the intervention arm was 1.5,"['Men with Prostate Cancer', 'Sixty-four men (n=32 per arm) completed the study; 88% completed 12-wk assessments (intervention, 94%; control, 82', '76 men with clinical stage T1-T3a prostate cancer', 'men with prostate cancer']","['Technology-enhanced Behavioral Change Intervention', 'digital lifestyle intervention', 'Website, Fitbit One, and text messaging to facilitate adoption of eight behaviors: vigorous activity, smoking cessation, and six diet improvements']","['feasibility and acceptability', 'feasibility and acceptability based on recruitment and user data, and surveys, respectively', 'quality of life, anthropometrics, and circulating biomarkers after 12wk, and behaviors after 1yr', 'Median (IQR) absolute changes in the P8 score', 'Feasibility, Acceptability, and Behavioral Outcomes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034380'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",76.0,0.102029,The estimated mean score of the intervention arm was 1.5,"[{'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Kenfield', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA. Electronic address: stacey.kenfield@ucsf.edu.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Van Blarigan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Ameli', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Lavaki', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Cedars', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Paciorek', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Monroy', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lucy K', 'Initials': 'LK', 'LastName': 'Tantum', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Signorell', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Jung H', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Carroll', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'June M', 'Initials': 'JM', 'LastName': 'Chan', 'Affiliation': 'Department of Urology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA.'}]",European urology,['10.1016/j.eururo.2018.12.040']
747,30462198,Cryoablation with an 8-mm tip catheter in the treatment of atrioventricular nodal re-entrant tachycardia: results from a randomized controlled trial (CRYOABLATE).,"AIMS


This was a randomized controlled study performed to compare 8 mm-tip catheter cryoablation (CRYO) with radiofrequency ablation (RFA) in treating atrioventricular nodal re-entrant tachycardia (AVNRT).
METHODS AND RESULTS


A total of 158 patients (103 women, mean age 48.9 ± 14.1) with symptomatic AVNRT (140 typical; 18 atypical) were randomized to undergo CRYO with an 8 mm-tip catheter (n = 80) or RFA (n = 78). The primary endpoint was a composite of acute procedural failure, inadvertent permanent atrioventricular block (AVB) and recurrence at 12 months. No significant difference was observed between CRYO and RFA groups in primary endpoint (7.5 vs. 11.5%; P = 0.764), 12-month recurrence rate (3.8 vs. 1.3%; P = 0.358), inadvertent permanent AVB (0 vs. 1.3%; P = 0.307), and acute procedural failure (3.7 vs. 9%; P = 0.128). In patients with acute procedure failure, success was achieved in 5 of 7 patients (71.4%) in RFA group and 2 of 3 patients (66.7%) in CRYO group on cross-over. There was no significant difference in procedural duration between CRYO and RFA groups (72.4 ± 41.6 vs. 63.7 ± 29.8 min; P = 0.13), but fluoroscopic duration in CRYO group was significantly shorter (3.4 ± 6.3 vs. 6.7 ± 7.4 min; P = 0.005). Patient pain score (2.7 ± 2.7 vs. 4.6 ± 2.7; P < 0.001) and operator stress score (2.3 ± 1.3 vs. 4.9 ± 2; P < 0.001) were significantly lower in CRYO group.
CONCLUSIONS


Cryoablation with an 8 mm-tip catheter is shown to be comparable to RFA in treating AVNRT in terms of efficacy and safety. Additional advantages in CRYO include shorter fluoroscopic time, lower patient pain perception, and operator stress level.",2019,"CONCLUSIONS


Cryoablation with an 8 mm-tip catheter is shown to be comparable to RFA in treating AVNRT in terms of efficacy and safety.","['158 patients (103 women, mean age 48.9\u2009±\u200914.1) with symptomatic AVNRT (140 typical; 18 atypical', 'atrioventricular nodal re-entrant tachycardia']","['Cryoablation with an 8-mm tip catheter', '8\u2009mm-tip catheter cryoablation (CRYO) with radiofrequency ablation (RFA', 'CRYO with an 8\u2009mm-tip catheter (n\u2009=\u200980) or RFA']","['acute procedural failure', 'inadvertent permanent AVB', 'operator stress score', 'shorter fluoroscopic time, lower patient pain perception, and operator stress level', 'procedural duration', 'fluoroscopic duration', 'Patient pain score', 'composite of acute procedural failure, inadvertent permanent atrioventricular block (AVB) and recurrence', 'efficacy and safety', '12-month recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]","[{'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0004245', 'cui_str': 'Atrioventricular Conduction Block'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",158.0,0.136833,"CONCLUSIONS


Cryoablation with an 8 mm-tip catheter is shown to be comparable to RFA in treating AVNRT in terms of efficacy and safety.","[{'ForeName': 'Ngai-Yin', 'Initials': 'NY', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Geriatrics, Princess Margaret Hospital, Rm 223, Block J, 2-10 Princess Margaret Hospital Road, Lai Chi Kok, Kowloon, Hong Kong.'}, {'ForeName': 'Ngai-Shing', 'Initials': 'NS', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine & Geriatrics, Princess Margaret Hospital, Rm 223, Block J, 2-10 Princess Margaret Hospital Road, Lai Chi Kok, Kowloon, Hong Kong.'}, {'ForeName': 'Ho-Chuen', 'Initials': 'HC', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine & Geriatrics, Princess Margaret Hospital, Rm 223, Block J, 2-10 Princess Margaret Hospital Road, Lai Chi Kok, Kowloon, Hong Kong.'}, {'ForeName': 'Lian-Yu', 'Initials': 'LY', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Chih-Chieh', 'Initials': 'CC', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jiunn-Lee', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taiwan.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy225']
748,30608607,B-Sure: a randomized pilot trial of an interactive web-based decision support aid versus usual care in average-risk breast cancer patients considering contralateral prophylactic mastectomy.,"The use of contralateral prophylactic mastectomy (CPM) is increasing among breast cancer patients who are at average or ""sporadic"" risk for contralateral breast cancer. Because CPM provides no survival benefit for these patients, it is not medically recommended for them. Decision support aids may facilitate more informed, higher quality CPM decision. The purpose of this study was to evaluate the feasibility and acceptability of B-Sure, an online decision support aid to facilitate informed decisions regarding CPM, and to compare the impact of B-Sure in increasing CPM knowledge, reducing decisional conflict, and increasing preparedness to make the CPM decision among breast cancer patients at sporadic risk who are considering CPM. Ninety-three patients with unilateral, nonhereditary breast cancer considering CPM completed a baseline survey, were randomized to receive B-Sure or Usual care, and completed a 4-week follow-up survey assessing decisional conflict, preparedness to make the CPM decision, and CPM knowledge as well as self-efficacy, perceived risk, worry, CPM motivations, and the surgical decision. Study participation was high. B-Sure was viewed by almost 80% of the participants and was evaluated positively. At follow-up, patients assigned to B-Sure reported significantly higher clarity regarding the personal values relevant to the CPM decision and higher knowledge about CPM. B-Sure had smaller effects on other aspects of decisional conflict. B-Sure improved CPM knowledge and reduced decisional conflict. Patients considering CPM may benefit from an online decision support aid, but may be sensitive to approaches that they perceive as biased against CPM.",2020,B-Sure had smaller effects on other aspects of decisional conflict.,"['breast cancer patients who are at average or ""sporadic"" risk for contralateral breast cancer', 'breast cancer patients at sporadic risk who are considering CPM', 'Ninety-three patients with unilateral, nonhereditary breast cancer considering CPM completed a baseline survey', 'average-risk breast cancer patients considering contralateral prophylactic mastectomy']","['interactive web-based decision support aid versus usual care', 'B-Sure or Usual care', 'contralateral prophylactic mastectomy (CPM']","['feasibility and acceptability of B', 'CPM knowledge and reduced decisional conflict', 'survival benefit']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205422', 'cui_str': 'Sporadic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1705768'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1705768'}, {'cui': 'C0392412', 'cui_str': 'cpm'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",93.0,0.024215,B-Sure had smaller effects on other aspects of decisional conflict.,"[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Manne', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kashy', 'Affiliation': 'Department of Psychology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby133']
749,31673708,A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases: Clinical Trial Protocol.,"BACKGROUND


Brain metastases which require resection are treated with surgery followed by whole brain radiation therapy or postoperative cavity boost stereotactic radiosurgery (POCBS). Recently a novel strategy using neoadjuvant stereotactic radiosurgery (NaSRS) followed by resection was reported, demonstrating lower rates of postoperative leptomeningeal dissemination (LMD) and symptomatic radiation toxicity compared to a comparative cohort of patients treated with postoperative SRS.
OBJECTIVE


To determine if the rate of symptomatic radiation toxicity at 1 yr in patients who receive NaSRS differs significantly from historical rates for patients treated with POCBS.
METHODS


This is a multi-center, non-randomized, open phase II clinical trial. A total of 30 patients with up to 10 brain metastases, at least 1 of which is appropriate for surgical resection, will be enrolled for over 4 yr. All enrolled patients will be assigned to receive NaSRS followed by surgery.
EXPECTED OUTCOME


This study will clarify whether symptomatic radiation toxicity caused by NaSRS is significantly decreased compared to historical rates associated with POCBS. Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival. Tertiary analyses will include correlation between LC and radiation toxicity with pretreatment clinical factors, serum markers, radiomic features, and molecular assessments of the resected tumors.
DISCUSSION


This prospective study will determine the toxicity associated with NaSRS and provide additional quantitative metrics of efficacy for future comparative trials.",2020,"Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival.","['30 patients with up to 10 brain metastases, at least 1 of which is appropriate for surgical resection, will be enrolled for over 4 yr', 'Large Brain Metastases', 'patients who receive NaSRS differs significantly from historical rates for patients treated with POCBS']","['neoadjuvant stereotactic radiosurgery (NaSRS', 'surgery followed by whole brain radiation therapy or postoperative cavity boost stereotactic radiosurgery (POCBS', 'NaSRS followed by surgery', 'Neoadjuvant Stereotactic Radiosurgery']","['postoperative leptomeningeal dissemination (LMD) and symptomatic radiation toxicity', '1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival', 'rate of symptomatic radiation toxicity', 'LC and radiation toxicity with pretreatment clinical factors, serum markers, radiomic features, and molecular assessments of the resected tumors', 'symptomatic radiation toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0011793', 'cui_str': 'Dextran 40'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.0605815,"Secondary endpoints will include 1-yr local control (LC) of the treated lesion, 1-yr rates of LMD, median survival and 2-yr rates of progression-free and overall survival.","[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takami', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Nassiri', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Moraes', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Gelareh', 'Initials': 'G', 'LastName': 'Zadeh', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Conrad', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Berlin', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Laperriere', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Barbara-Ann', 'Initials': 'BA', 'LastName': 'Millar', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David Benjamin', 'Initials': 'DB', 'LastName': 'Shultz', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kongkham', 'Affiliation': 'Division of Neurosurgery, Toronto Western Hospital, Toronto, Ontario, Canada.'}]",Neurosurgery,['10.1093/neuros/nyz442']
750,30652944,Balance training versus balance training and foot and ankle mobilization: a pilot randomized trial in community-dwelling older adults.,"Background : Balance limitations and foot and ankle problems are common in older adults.  Objective : To determine the impact of augmented balance training with foot and ankle mobilizations (FAMs) on balance in older adults.  Methods : Two-arm pilot randomized trial. Both groups underwent a 4-week conventional balance training. Additionally, the experimental group received four sessions of FAM. Balance measurement, as assessed by the Berg Balance Scale, was the primary outcome. The secondary outcome was the ankle range of movement (ROM). Outcomes were evaluated 1 day before and after intervention, and at 3 months' post-intervention (midterm).  Results : Twenty-eight participants completed the study (14 control, 14 experimental). No between-group differences were observed in terms of balance. Similarly, both groups significantly improved the ankle ROM, but the effects persisted at 3 months only in the FAM group.  Conclusion : Augmented balance training with FAM does not improve balance of older adults over conventional methods, but may help to correct ankle mobility limitations at midterm. As this was a pilot study, further studies with adequate sample size are warranted to validate our findings, and elucidate the dose-response relationship of FAM with improvement of balance and ROM in older adults.",2020,No between-group differences were observed in terms of balance.,"['Twenty-eight participants completed the study (14 control, 14 experimental', 'community-dwelling older adults', 'older adults']","['conventional balance training', 'FAM', 'augmented balance training with foot and ankle mobilizations (FAMs', 'Balance training versus balance training and foot and ankle mobilization']","['ankle ROM', 'balance', 'ankle range of movement (ROM']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",28.0,0.0505995,No between-group differences were observed in terms of balance.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hernández-Guillén', 'Affiliation': 'Department of Physiotherapy, University of Valencia , Valencia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Sanoguera-Torres', 'Affiliation': 'Department of Physiotherapy, University of Valencia , Valencia, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martínez-Pérez', 'Affiliation': 'Department of Developmental and Educational Psychology, University of Valencia , Valencia, Spain.'}, {'ForeName': 'Celedonia', 'Initials': 'C', 'LastName': 'Igual-Camacho', 'Affiliation': 'Department of Physiotherapy, University of Valencia , Valencia, Spain.'}, {'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Blasco', 'Affiliation': 'Department of Physiotherapy, University of Valencia , Valencia, Spain.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1563931']
751,30431467,Testing the Efficacy of a Web-Based Parent-Adolescent Sexual Communication Intervention Among Puerto Ricans.,"This randomized controlled trial tested the efficacy of a Web-based intervention to increase sexual communication between parents and adolescents. Parent/adolescent dyads (n = 660) were recruited from communities in the San Juan area and randomly assigned to the Cuídalos sexual communication or physical activity program. Parent assessments were obtained preintervention and at 3-, 6-, and 12-month follow-up. Parents in the experimental group reported significantly more sexual communication (ie, peer pressure, sexual prevention, protection, risk) over time than parents in the control group. Results support the efficacy of the Cuídalos Web-based format and provide insight into future Web-based sexual health interventions for this population.",2019,"Parents in the experimental group reported significantly more sexual communication (ie, peer pressure, sexual prevention, protection, risk) over time than parents in the control group.","['parents and adolescents', 'Parent/adolescent dyads (n = 660) were recruited from communities in the San Juan area and randomly assigned to the', 'Puerto Ricans']","['Web-Based Parent-Adolescent Sexual Communication Intervention', 'Web-based intervention', 'Cuídalos sexual communication or physical activity program']","['sexual communication', 'sexual communication (ie, peer pressure, sexual prevention, protection, risk) over time']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0562366', 'cui_str': 'Peer Pressure'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",660.0,0.0354965,"Parents in the experimental group reported significantly more sexual communication (ie, peer pressure, sexual prevention, protection, risk) over time than parents in the control group.","[{'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Varas-Díaz', 'Affiliation': 'Global and Sociocultural Studies, School of International and Public Affairs, Florida International University, Miami (Dr Varas-Díaz); Institute for Psychological Research, Universidad del Este, Carolina, Puerto Rico (Dr Betancourt-Díaz); and University of Pennsylvania School of Nursing, Philadelphia (Mss Lozano and DiNapoli, Mr Huang, and Drs Hanlon and Villarruel).'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Betancourt-Díaz', 'Affiliation': ''}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Lozano', 'Affiliation': ''}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'DiNapoli', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hanlon', 'Affiliation': ''}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Villarruel', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000209']
752,30664895,Time to Prostate-specific Antigen Nadir and the Risk of Death From Prostate Cancer Following Radiation and Androgen Deprivation Therapy.,"OBJECTIVE


To assess whether the time to prostate-specific antigen (PSA) nadir (TTN) has differential prognostic value in men who reach an undetectable vs detectable PSA nadir.
METHODS


Two hundred and four men from a prospective randomized controlled trial involving radiation therapy with or without 6 months of androgen deprivation therapy in unfavorable risk Prostate cancer (CaP) at academic or community based centers in Massachusetts, enrolled between 1995 and 2001. Adjusted hazard ratios (AHR) of the risk of CaP-specific mortality calculated using Fine and Gray competing risk regression.
RESULTS


After a median follow-up of 18.17years, 160 men died; 30 (18.75%) of CaP. Among men with a PSA nadir ≥ 0.2ng/ml, a TTN < median (12 months) was significantly associated with an increased CaP-specific mortality-risk vs the median or more (AHR 5.07, 95% CI 2.10-12.23, P <.001); whereas this association was not observed among men with a PSA nadir of < 0.2ng/mL, (AHR 9.9, 95% CI 0.23-433.8, P = .23).
CONCLUSION


Men with both a short TTN and detectable PSA nadir could be considered for entry on randomized controlled trials at a novel entry point prior to PSA failure at the time of PSA nadir to completeplanned conventional androgen deprivation therapy vs that plus agent(s) shown to improve outcomes in men with or at high risk of having castrate-resistant CaP.",2019,"a TTN < median (12 months) was significantly associated with an increased CaP-specific mortality-risk vs the median or more (AHR 5.07, 95% CI 2.10-12.23, P <.001); whereas this association was not observed among men with a PSA nadir of < 0.2ng/mL, (AHR 9.9, 95% CI 0.23-433.8, P = .23).
","['Two hundred and four men', 'Men with both a short TTN and detectable PSA nadir', 'men with a PSA nadir ≥', 'unfavorable risk Prostate cancer (CaP) at academic or community based centers in Massachusetts, enrolled between 1995 and 2001', 'men who reach an undetectable vs detectable PSA nadir', 'men with or at high risk of having castrate-resistant CaP']","['Radiation and Androgen Deprivation Therapy', 'CaP', 'radiation therapy with or without 6 months of androgen deprivation therapy']","['CaP-specific mortality-risk', 'time to prostate-specific antigen (PSA) nadir (TTN', 'Adjusted hazard ratios (AHR) of the risk of CaP-specific mortality']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",204.0,0.172583,"a TTN < median (12 months) was significantly associated with an increased CaP-specific mortality-risk vs the median or more (AHR 5.07, 95% CI 2.10-12.23, P <.001); whereas this association was not observed among men with a PSA nadir of < 0.2ng/mL, (AHR 9.9, 95% CI 0.23-433.8, P = .23).
","[{'ForeName': 'Luke R G', 'Initials': 'LRG', 'LastName': 'Pike', 'Affiliation': ""Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA; Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA. Electronic address: lrgpike@gmail.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Computer Science and Statistics, University of Rhode Island, South Kingstown, RI.'}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, University of Connecticut, Storrs, CT.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Loffredo', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA.""}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Renshaw', 'Affiliation': 'Department of Pathology, Baptist Hospital and Miami Cancer Institute, Miami, Florida.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pfail', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': ""D'Amico"", 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA.""}]",Urology,['10.1016/j.urology.2018.11.056']
753,26865254,"Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.","BACKGROUND


Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country.
METHODS/DESIGN


A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status.
DISCUSSION


Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation's mental health Gap Action Programme to scale-up mental health care globally.
TRIAL REGISTRATION


NCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.",2016,The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months.,"['people with SMD', '324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic', 'people with SMD in a rural, low-income African country', 'people with a severe mental disorder (SMD', 'predominantly rural area of Ethiopia']",['specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital'],"['change in symptom severity', 'Sustainability and cost-effectiveness', 'effectiveness, acceptability, feasibility and sustainability', 'functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454695', 'cui_str': 'African country (geographic location)'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C2364092', 'cui_str': 'Medication side effects present'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",324.0,0.190848,The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. charlotte.hanlon@kcl.ac.uk.'}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. atalay.alem@gmail.com.'}, {'ForeName': 'Girmay', 'Initials': 'G', 'LastName': 'Medhin', 'Affiliation': 'Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia. gtmedhin@yahoo.com.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Shibre', 'Affiliation': 'Horizon Health Network, Dr Everett Chalmers Regional Hospital, Psychiatry, Fredericton, New Brunswick, Canada. teshome.kelkile@gmail.com.'}, {'ForeName': 'Dawit A', 'Initials': 'DA', 'LastName': 'Ejigu', 'Affiliation': ""Department of Pharmacology, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia. daejigu@gmail.com.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Negussie', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. movsic@yahoo.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. michael.dewey@kcl.ac.uk.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Wissow', 'Affiliation': 'Department of Health, Behaviour and Society, Johns Hopkins School of Public Health, Baltimore, MD, USA. lwissow@jhmi.edu.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. martin.prince@kcl.ac.uk.""}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA. ess8@cumc.columbia.edu.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. crick.lund@uct.ac.za.""}, {'ForeName': 'Abebaw', 'Initials': 'A', 'LastName': 'Fekadu', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. abe.wassie@kcl.ac.uk.'}]",Trials,['10.1186/s13063-016-1191-x']
754,30486656,"Multicomponent intervention combining a cognitive stimulation group and tai chi to reduce cognitive decline among community-dwelling older adults with probable dementia: A multi-center, randomized controlled trial.","OBJECTIVE


This research study aims to evaluate the effectiveness of a multicomponent intervention that combines a cognitive stimulation group and tai chi to reduce cognitive decline among community-dwelling Chinese older adults with probable dementia.
METHODS


A multi-center, randomized controlled trial design was adopted in this study. In addition to treat as usual, the treatment group ( n  = 41) participated in a structured cognitive stimulation group followed by tai chi twice a week, with a total of 14 sessions held during the study period. The control group ( n  = 39) received treat as usual. Mattis Dementia Rating Scale and Mini-Mental State Examination were used for assessing the cognitive abilities of participants in the pre- and post-treatment periods.
RESULTS


A 2 × 2 repeated measures analysis of covariance demonstrated that the treatment group was more effective than the control group on improving Dementia Rating Scale score ( F  = 7.45,  p  < .01) with a moderate effect size (partial eta square = .09) and Mini-Mental State Examination score ( F  = 9.96,  p  < .01) with a moderate to large effect size (partial eta square = .12) after controlling for age, gender, educational level, marital status, and number of physical illnesses.
CONCLUSION


The present study demonstrates the effectiveness of the multicomponent intervention on improving cognitive ability among community-dwelling older adults with probable dementia, suggesting that the multicomponent intervention can facilitate early identification, assessment, and treatment for community-dwelling older adults with probable dementia.",2020,"A 2 × 2 repeated measures analysis of covariance demonstrated that the treatment group was more effective than the control group on improving Dementia Rating Scale score ( F = 7.45, p < .01) with a moderate effect size (partial eta square = .09) and Mini-Mental State Examination score ( F = 9.96, p < .01) with a moderate to large effect size (partial eta square = .12) after controlling for age, gender, educational level, marital status, and number of physical illnesses.
","['community-dwelling older adults with probable dementia', 'community-dwelling Chinese older adults with probable dementia']","['multicomponent intervention', 'Multicomponent intervention combining a cognitive stimulation group and tai chi', 'multicomponent intervention that combines a cognitive stimulation group and tai chi', 'structured cognitive stimulation group followed by tai chi']","['Mattis Dementia Rating Scale and Mini-Mental State Examination', 'improving Dementia Rating Scale score', 'Mini-Mental State Examination score', 'cognitive decline', 'cognitive ability']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",41.0,0.0542632,"A 2 × 2 repeated measures analysis of covariance demonstrated that the treatment group was more effective than the control group on improving Dementia Rating Scale score ( F = 7.45, p < .01) with a moderate effect size (partial eta square = .09) and Mini-Mental State Examination score ( F = 9.96, p < .01) with a moderate to large effect size (partial eta square = .12) after controlling for age, gender, educational level, marital status, and number of physical illnesses.
","[{'ForeName': 'Daniel Kim-Wan', 'Initials': 'DK', 'LastName': 'Young', 'Affiliation': 'Department of Social Work, Hong Kong Baptist University, Hong Kong.'}]","Dementia (London, England)",['10.1177/1471301218814637']
755,30274549,Effect of exercise order with barbell and machine modalities on upper body volume load and myoelectric activity.,"The purpose of this study was to investigate the influence of exercise order on volume load (VL) and myoelectric activation (EMG) during the bench press (BP), military press (MP) and close-grip bench press (CGBP) exercises executed with a barbell and Smith machine. Twelve men experienced in resistance training performed four different exercise sessions in randomised order. Each session consisted of four sets of a given exercise order: O1 = CGBP + MP + BP with barbell; O2 = inverse O1 with barbell, O3 = same O1 with Smith Machine; O4 = same O2 with Smith machine. EMG was assessed for the Clavicular head  pectoralis major  (PMC), anterior  deltoid  (AD),  triceps brachii  long head (TBLH) and  biceps brachii  (BB). Results showed that VL in BP was affected by exercise order, independent of the mode ( p  < 0.05). However, the CGBP showed higher VL in O1. Moreover, when the BP was positioned last in the sequence (O1 and O3), myoelectric activity was higher for PMC, AD and TBLH ( p  < 0.05). Findings were similar in the CGBP (PMC and TBLH), but for the AD (Smith machine > barbell,  p  < 0.05). Therefore, it appears that the order and modes of exercises influence both volume load and myoelectric activation patterns during multiple set of resistance training.",2020,"Results showed that VL in BP was affected by exercise order, independent of the mode (p < 0.05).",['Twelve men experienced in resistance training'],"['exercise order with barbell and machine modalities', 'CGBP\xa0+\xa0MP\xa0+\xa0BP with barbell; O2\xa0=\xa0inverse O1 with barbell, O3\xa0=\xa0same O1 with Smith Machine; O4\xa0=\xa0same O2 with Smith machine', 'bench press (BP), military press (MP) and close-grip bench press (CGBP) exercises executed with a barbell and Smith machine']","['CGBP (PMC and TBLH', 'sequence (O1 and O3), myoelectric activity', 'volume load (VL) and myoelectric activation (EMG', 'Clavicular head pectoralis major (PMC), anterior deltoid (AD), triceps brachii long head (TBLH) and biceps brachii (BB', 'VL in BP', 'upper body volume load and myoelectric activity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}]","[{'cui': 'C1568303', 'cui_str': 'poly(2-methacryloyloxyethyl phosphorylcholine-co-n-stearyl methacrylate)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",12.0,0.0182716,"Results showed that VL in BP was affected by exercise order, independent of the mode (p < 0.05).","[{'ForeName': 'Ewertton S', 'Initials': 'ES', 'LastName': 'Bezerra', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, City University of New York , Bronx, NY, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Paz', 'Affiliation': 'School of Physical Education and Sports, Federal University of Rio de Janeiro , Rio de Janeiro, Brazil.'}, {'ForeName': 'Déborah de Araújo', 'Initials': 'DA', 'LastName': 'Farias', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Raphael L', 'Initials': 'RL', 'LastName': 'Sakugawa', 'Affiliation': 'Center of Sports, Federal University of Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Iago', 'Initials': 'I', 'LastName': 'Vieira', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Rossato', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas , Manaus, Brazil.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Miranda', 'Affiliation': 'School of Physical Education and Sports, Federal University of Rio de Janeiro , Rio de Janeiro, Brazil.'}]",Sports biomechanics,['10.1080/14763141.2018.1515980']
756,32408551,Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents.,"Children who live with smokers are at risk of poor health, and of becoming smokers themselves. Misperceptions of the nature of tobacco smoke exposure have been demonstrated among parents, resulting in continued smoking in their children's environment. This study aimed to change parents' perceptions of exposure by providing information on second- and third-hand exposure and personalised information on children's exposure [NIH registry (NCT02867241)]. One hundred and fifty-nine families with a child < 8 years and at least one smoking parent were randomized into intervention (69), control (70), and enhanced control (20) groups. Reported exposure, parental smoking details, and a child hair sample were obtained at the start of the study and 6-8 months later. Parental perceptions of exposure (PPE) were assessed via a questionnaire. The intervention consisted of motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures. PPE were significantly higher at the study end (94.6 ± 17.6) compared to study beginning (86.5 ± 19.3) in intervention and enhanced control groups (t(72) = -3.950;  p  < 0.001). PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020). There was no significant interaction between time and group. Parallel changes in parental smoking behaviour were found. Parental perceptions of exposure were increased significantly post intervention, indicating that they can be altered. By making parents more aware of exposure and the circumstances in which it occurs, we can help parents change their smoking behaviour and better protect their children.",2020,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"['Children who live with smokers', 'One hundred and fifty-nine families with a child < 8 years and at least one smoking parent']","[""motivational interviews, feedback of home air quality and child's hair nicotine level, and information brochures""]","['parental smoking behaviour', 'PPE', 'Parental perceptions of exposure (PPE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",159.0,0.0176672,PPE at study end were significantly higher in the intervention group compared to the regular control group ( p  = 0.020).,"[{'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Myers', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Shiloh', 'Affiliation': 'School of Psychological Sciences, Gershon H. Gordon Faculty of Social Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Zucker', 'Affiliation': 'Department of Statistics, Hebrew University, Mount Scopus, Jerusalem 9190501, Israel.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Rosen', 'Affiliation': 'Department of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 6997801, Israel.'}]",International journal of environmental research and public health,['10.3390/ijerph17103349']
757,30535101,Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial.,"Weight management after breast cancer (BC) treatment in African American (AA) women is crucial to reduce comorbid conditions and health disparities. We examined feasibility and potential efficacy of commercial eHealth/mHealth tools for weight management in AA BC survivors in New Jersey. Participants (N = 35) were randomized to an intervention (SparkPeople) plus activity tracker, Fitbit Charge (n = 18), or wait-list active control group (Fitbit only, n = 17). Anthropometric, behavioral, and quality of life (QOL) outcomes were collected at baseline, 3, 6, and 12 months. Differences in outcomes were assessed using intent-to-treat analysis. Retention was 97.1%. Both groups lost weight, with no significant differences between groups. At month 6, mean weight change was: intervention: -1.71 kg (SD 2.33; p = .006), 33.3% lost ≥3% of baseline weight; control: -2.54 kg (SD 4.00, p = .002), 23.5% lost ≥3% weight. Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001). Number of days logged food per week was associated with decreases in waist circumference at 6 months (β -0.79, 95% CI, -1.49, -0.09, p = .030) and 12 months (β -2.16, 95% CI, -4.17, -0.15, p = .038). Weight loss was maintained at 12 months. This is the first study to demonstrate potential efficacy of commercial eHealth/mHealth tools for weight loss in AA BC survivors, without additional counseling from the research team. If effective, they may be convenient weight loss tools that can be easily and widely disseminated. Clinical Trials registration: ClinicalTrials.gov NCT02699983.",2020,"Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001).","['AA BC survivors', 'AA BC survivors in New Jersey', 'after breast cancer (BC) treatment in African American (AA) women', 'African American breast cancer survivors', 'Participants (N = 35']","['commercial mHealth/eHealth tools', 'commercial eHealth/mHealth tools', 'Weight management', 'intervention (SparkPeople) plus activity tracker, Fitbit Charge (n = 18), or wait-list active control']","['QOL', 'waist circumference', 'mean weight change', 'weight loss', 'Weight loss', 'healthy eating', 'Anthropometric, behavioral, and quality of life (QOL) outcomes', 'decreasing calories']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0034380'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]",35.0,0.138796,"Intervention participants achieved significant improvements in waist circumference (-3.56 cm, SD 4.70, p = .005), QOL (p = .030), and use of strategies for healthy eating (p = .025) and decreasing calories (p < .001).","[{'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Ferrante', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Devine', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Bator', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Ohman-Strickland', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Bandera', 'Affiliation': 'Cancer Prevention, Control and Population Research, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby124']
758,31589323,Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain.,"INTRODUCTION


This study explored the efficacy of combination lorcaserin and nicotine patch for smoking cessation treatment and prevention of postsmoking cessation weight gain.
METHODS


We conducted a trial in which 61 adult daily smokers were asked to quit smoking using a combination of lorcaserin and nicotine patch. During the first 2 weeks of treatment prior to the quit day, participants were randomized to receive either lorcaserin (10 mg twice daily) plus nicotine patch (21 mg) or placebo plus nicotine patch (21 mg). Following this 2-week period, participants received both medications for 12 weeks. Outcomes included 4-week continuous smoking abstinence at the end of treatment (weeks 7-10 postquit attempt), weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward.
RESULTS


Biochemically confirmed continuous smoking abstinence from 7 to 10 weeks postquit attempt was 31.1% (90% confidence interval, 21.4%-40.8%). Participants who quit smoking showed no weight gain; in fact, mean weight change was minus 0.16 kg (SD = 3.27) over the study period. There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen. During the prequit randomization period, lorcaserin versus placebo reduced the impact of smoking to relieve craving for cigarettes as well as the sensory enjoyment of smoking (p = .005). Adherence and tolerability to lorcaserin and nicotine patch was good.
CONCLUSIONS


The combination of lorcaserin and nicotine patch was well tolerated, associated with a relatively high smoking abstinence rate, and effectively prevented weight gain associated with quitting smoking.
IMPLICATIONS


This report provides an important contribution to the literature because it details evidence of a medication combination-lorcaserin and nicotine-that is effective for smoking cessation and for ameliorating weight gain associated with smoking cessation. For many smokers, postcessation weight gain is a major obstacle to quitting, and this medication combination provides a suitable treatment option for these smokers.
CLINICAL TRIAL REGISTRATION


NCT02906644.",2020,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"['Smoking Cessation Without Weight Gain', '61 adult daily smokers']","['lorcaserin versus placebo', 'lorcaserin', 'placebo plus nicotine patch', 'lorcaserin and nicotine patch', 'combination lorcaserin and nicotine patch', 'quit smoking using a combination of lorcaserin and nicotine patch', 'Combination Lorcaserin and Nicotine Patch', 'nicotine patch']","['sensory enjoyment of smoking and successful quit outcome', 'mean weight change', '4-week continuous smoking abstinence', 'weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward', 'Adherence and tolerability', 'continuous smoking abstinence', 'weight gain']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",61.0,0.0300442,There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen.,"[{'ForeName': 'Jed E', 'Initials': 'JE', 'LastName': 'Rose', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Duke University, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz149']
759,31934834,Long-Term Effect on HbA1c in Poorly Controlled Diabetic Patients Following Nonmydriatic Retinal Image Review at the Time of Endocrinology Visit.,"Background:   Patient education demonstrates variable benefits on diabetes control.   Introduction:   To examine the effect of discussing nonmydriatic retinal imaging findings during a single endocrinology visit on HbA1c levels after 6, 12, and 60 months.   Materials and Methods:   Patients with HbA1c >8.0% and diabetic retinopathy were previously recruited for a prospective study looking at the change in HbA1c at 3 months between those assigned to a session of nonmydriatic imaging with discussion of retinal findings and those assigned to routine endocrinology evaluation alone. The patients were subsequently evaluated at 6, 12, and 60 months after the initial intervention.   Results:   Fifty-three of the 57 originally recruited intervention subjects (93%) and 48 of 54 subjects in the original control group (89%) were evaluated at 6 and 12 months and 44 patients in each group (75% and 81%, respectively) at 60 months. At 6 months, the intervention group maintained larger decreases in median HbA1c compared to control (-1.1 vs. -0.3, respectively,  p  = 0.002) with a trend persisting at 12 months (-0.6 vs. -0.2, respectively,  p  = 0.07). After 60 months, there was no significant difference in the median change in HbA1c between treatment and control groups (0.3 vs. 0.1, respectively,  p  = 0.54).   Discussion:   The short-term improvement in HbA1c resulting from discussion of retinal findings persists throughout the first year in this diabetic cohort, but its magnitude declines with time and becomes statistically insignificant at some point between 6 and 12 months.   Conclusions:   In patients with poorly controlled diabetes, retinal imaging review may help improve glycemic control but may require repetition periodically for benefit beyond 6 months.",2020,"At 6 months, the intervention group maintained larger decreases in median HbA1c compared to control (-1.1 vs. -0.3, respectively, p = 0.002) with a trend persisting at 12 months (-0.6 vs. -0.2, respectively, p = 0.07).","['Fifty-three of the 57 originally recruited intervention subjects (93%) and 48 of 54 subjects in the original control group (89', 'patients with poorly controlled diabetes', 'Patients with HbA1c >8.0% and diabetic retinopathy']",['nonmydriatic imaging with discussion of retinal findings and those assigned to routine endocrinology evaluation alone'],"['median change in HbA1c', 'median HbA1c']","[{'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",54.0,0.0386559,"At 6 months, the intervention group maintained larger decreases in median HbA1c compared to control (-1.1 vs. -0.3, respectively, p = 0.002) with a trend persisting at 12 months (-0.6 vs. -0.2, respectively, p = 0.07).","[{'ForeName': 'Lloyd Paul', 'Initials': 'LP', 'LastName': 'Aiello', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Cavallerano', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Nisreen', 'Initials': 'N', 'LastName': 'Salti', 'Affiliation': 'Department of Economics, Faculty of Arts and Sciences, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nasrallah', 'Affiliation': 'Divison of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Carl Joe', 'Initials': 'CJ', 'LastName': 'Mehanna', 'Affiliation': 'Department of Ophthalmology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Nasrine Anais', 'Initials': 'NA', 'LastName': 'El Salloukh', 'Affiliation': 'Department of Ophthalmology, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Haytham I', 'Initials': 'HI', 'LastName': 'Salti', 'Affiliation': 'Department of Ophthalmology, American University of Beirut Medical Center, Beirut, Lebanon.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0239']
760,31876947,Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology.
METHODS


EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions.
CONCLUSION


The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.",2020,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering.",['patients with chronic pain who desire to reduce long-term opioid therapy'],"['cognitive behavioral therapy', 'Cognitive Behavioral Therapy', 'chronic pain self-management; and (3) usual care (taper only']",['Chronic Pain and Chronic Pain Self-Management'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",,0.0744989,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering.","[{'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Stanford Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lorig', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Kao', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Mardian', 'Affiliation': 'Department of Family, Community, and Preventive Medicine, Phoenix VA Health Care System, Chronic Pain Wellness Center, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stieg', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Department of Family Medicine, Intermountain Healthcare, Layton, Utah.'}, {'ForeName': 'Korina', 'Initials': 'K', 'LastName': 'DeBruyne', 'Affiliation': 'Division of Primary, Preventive and, Community Care, Stanford School of Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': ""James A. Haley Veterans' Hospital, University of South Florida School of Medicine, Tampa, Florida.""}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Okvat', 'Affiliation': 'Department of Family, Community, and Preventive Medicine, Phoenix VA Health Care System, Chronic Pain Wellness Center, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Flood', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'University of Maryland School of Nursing, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'King', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Van Dorsten', 'Affiliation': 'Colorado Center for Behavioral Medicine, Denver, Colorado.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pun', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Cheung', 'Affiliation': 'Thomas J. Long School of Pharmacy, University of the Pacific, Stockton, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz285']
761,27310331,"Pharmacokinetics, Safety, and Tolerability of Fevipiprant (QAW039), a Novel CRTh2 Receptor Antagonist: Results From 2 Randomized, Phase 1, Placebo-Controlled Studies in Healthy Volunteers.","We evaluated the pharmacokinetics (PK), safety, and tolerability of a novel oral CRTh2 antagonist, fevipiprant (QAW039), in healthy subjects. Peak concentrations of fevipiprant in plasma were observed 1-3 hours postdosing. Concentrations declined in a multiexponential manner, followed by an apparent terminal phase (t1/2 , ∼20 hours). Steady state was achieved in 4 days with <2-fold accumulation. Elimination was partly by renal excretion (≤30% of the dose) and glucuronidation. Food had minimal impact on the PK of fevipiprant, and it was well tolerated at single and multiple oral doses up to 500 mg/day. No dose-dependent adverse events were observed, and all the events were mild or moderate in severity. Systemic concentrations were sufficiently high to achieve relevant target occupancy, considering in vitro pharmacology data. In summary, the data support further development as a once-daily oral therapy for allergic diseases.",2016,"Food had minimal impact on the PK of fevipiprant, and it was well tolerated at single and multiple oral doses up to 500 mg/day.","['Healthy Volunteers', 'healthy subjects']","['novel oral CRTh2 antagonist, fevipiprant (QAW039', 'Placebo', 'Fevipiprant (QAW039']","['adverse events', 'renal excretion', 'Pharmacokinetics, Safety, and Tolerability', 'pharmacokinetics (PK), safety, and tolerability', 'Peak concentrations of fevipiprant in plasma']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4076895', 'cui_str': 'fevipiprant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4076895', 'cui_str': 'fevipiprant'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.0256162,"Food had minimal impact on the PK of fevipiprant, and it was well tolerated at single and multiple oral doses up to 500 mg/day.","[{'ForeName': 'Veit J', 'Initials': 'VJ', 'LastName': 'Erpenbeck', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Vets', 'Affiliation': 'SGS-Life Sciences, Antwerp, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Gheyle', 'Affiliation': 'SGS-Life Sciences, Antwerp, Belgium.'}, {'ForeName': 'Wande', 'Initials': 'W', 'LastName': 'Osuntokun', 'Affiliation': 'Novartis Institutes for Biomedical Research, Horsham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Larbig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Neelakantham', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sandham', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Dubois', 'Affiliation': 'Novartis Institutes for Biomedical Research, Horsham, United Kingdom.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Elbast', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goldsmith', 'Affiliation': 'Novartis Institutes for Biomedical Research, Horsham, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.244']
762,28039505,Factors supporting cardiomyopathy screening among at-risk adult survivors of pediatric malignancies.,"PURPOSE


Anthracyclines and chest irradiation place adult survivors of childhood cancer at risk of cardiomyopathy; many survivors do not obtain the recommended screening. Based on our recent clinical trial, the addition of telephone counseling to a printed survivorship care plan more than doubled survivors' risk-based screening. Here, we sought to measure the impact of specific factors targeted in the intervention for their impact on survivors' screening participation.
METHODS


Study population-survivors participating in a randomized longitudinal intervention trial. Survivor questionnaires and medical records at baseline and 1-year follow-up provided the data. Within- and between-group differences in factors were assessed at baseline and follow-up; structural equation modeling (SEM) identified direct and indirect effects on screening participation.
RESULTS


Of the 411 survivors, 55.3% were female, 89.3% white, 38.9% college graduates, and age 26-59 years (mean = 41 years, SD = 7.68 years). At follow-up, the counseling group demonstrated higher scores for intent to undergo screening (p < 0.001), adherence determination (p < 0.001), autonomous regulation (p < 0.001), competency (p = 0.03), perceived effort warranted for screening (p < 0.001), and perceived value of screening (p = 0.02). SEM identified four factors that directly influenced screening participation (n = 411, RMSEA = 0.02 [90% CI = 0.000-0.05]; CFI = 0.99; TLI = 0.99; WRMR = 0.63): the counseling intervention (p < 0.0001), intrinsic motivation (p < 0.0001), competency (p < 0.0001), and decisional control (p = 0.001); intrinsic motivation was also a mediator (p = 0.002) of screening participation.
CONCLUSIONS


Direct interpersonal interaction that focused on multiple modifiable, autonomy-supportive factors powerfully enhances the efficacy of a print survivorship care plan in increasing survivors' screening participation. This finding challenges providers to reach beyond the disease treatment focus and embrace these strategies in their behavior change efforts.",2017,"At follow-up, the counseling group demonstrated higher scores for intent to undergo screening (p < 0.001), adherence determination (p < 0.001), autonomous regulation (p < 0.001), competency (p = 0.03), perceived effort warranted for screening (p < 0.001), and perceived value of screening (p = 0.02).","[' 55.3% were female, 89.3% white, 38.9% college graduates, and age 26-59\xa0years (mean\xa0', 'adult survivors of childhood cancer at risk of cardiomyopathy', 'Study population-survivors participating', '41\xa0years, SD\xa0', '411 survivors']","['Anthracyclines and chest irradiation place', 'telephone counseling']","['adherence determination', 'intrinsic motivation', 'decisional control']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0535901,"At follow-up, the counseling group demonstrated higher scores for intent to undergo screening (p < 0.001), adherence determination (p < 0.001), autonomous regulation (p < 0.001), competency (p = 0.03), perceived effort warranted for screening (p < 0.001), and perceived value of screening (p = 0.02).","[{'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Cox', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-2794, USA. cox1072@bellsouth.net.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Rohit P', 'Initials': 'RP', 'LastName': 'Ojha', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-2794, USA.""}, {'ForeName': 'Brenda D', 'Initials': 'BD', 'LastName': 'Steen', 'Affiliation': ""Department of Anesthesia, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ogg', 'Affiliation': ""Department of Nursing Research, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105-2794, USA.""}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3530-6']
763,28064386,Brief supportive-expressive group therapy for partners of men with early stage prostate cancer: lessons learned from a negative randomized controlled trial.,"PURPOSE


The purpose of this paper is to report the results of a negative randomized controlled trial, which piloted brief supportive-expressive therapy (SET) for partners of men with prostate cancer, and to discuss lessons learned for future clinical trials.
METHODS


Partners of men with newly diagnosed, non-metastatic prostate cancer were randomized to SET (n = 45) or usual care (n = 32). SET involved six weekly group sessions emphasizing emotional expression, social support, and finding meaning in the cancer experience. Measures of mood disturbance, marital satisfaction, and social support were administered to both partners and patients at baseline, post-program, and at 3- and 6-month follow-up.
RESULTS


There were no significant differences between SET and the control group for either patients or their wives on any outcome. Regardless of group membership, partners reported improvements in total mood disturbance (p = .011), tension (p < .001), anger (p = .041), confusion (p < .001), state anxiety (p = .001), and emotional support (p = .037), and patients reported improvements in tension (p = .003), emotional support (p = .047), positive interaction support (p = .004), and overall social support (p = .026).
CONCLUSIONS


Compared to the natural course of recovery, SET did not improve psychosocial outcomes for either men with prostate cancer or their wives. Methodological challenges experienced in implementing this trial yield valuable lessons for future research, including designing interventions relevant to unique problems faced by specific groups, being closely guided by previous research, and the potential utility of screening for distress as an inclusion criteria in intervention trials.",2017,"Regardless of group membership, partners reported improvements in total mood disturbance (p = .011), tension (p < .001), anger (p = .041), confusion (p < .001), state anxiety (p = .001), and emotional support (p = .037), and patients reported improvements in tension (p = .003), emotional support (p = .047), positive interaction support (p = .004), and overall social support (p = .026).
","['Partners of men with newly diagnosed, non-metastatic prostate cancer', 'partners of men with prostate cancer', 'partners of men with early stage prostate cancer', 'men with prostate cancer or their wives']","['supportive-expressive therapy (SET', 'Brief supportive-expressive group therapy', 'usual care']","['psychosocial outcomes', 'emotional support', 'overall social support', 'tension', 'state anxiety', 'mood disturbance, marital satisfaction, and social support', 'positive interaction support', 'total mood disturbance']","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037438'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0446164,"Regardless of group membership, partners reported improvements in total mood disturbance (p = .011), tension (p < .001), anger (p = .041), confusion (p < .001), state anxiety (p = .001), and emotional support (p = .037), and patients reported improvements in tension (p = .003), emotional support (p = .047), positive interaction support (p = .004), and overall social support (p = .026).
","[{'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, 1331 29St NW, Calgary, T2N 4N2, Alberta, Canada. l.carlson@ucalgary.ca.'}, {'ForeName': 'Codie R', 'Initials': 'CR', 'LastName': 'Rouleau', 'Affiliation': 'Division of Psychosocial Oncology, Tom Baker Cancer Centre, Cancer Control Alberta, Holy Cross Site 2202 2nd St SW, Calgary, T2S 3C1, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Speca', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, 1331 29St NW, Calgary, T2N 4N2, Alberta, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, 1331 29St NW, Calgary, T2N 4N2, Alberta, Canada.'}, {'ForeName': 'Barry D', 'Initials': 'BD', 'LastName': 'Bultz', 'Affiliation': 'Department of Oncology, Cumming School of Medicine, University of Calgary, 1331 29St NW, Calgary, T2N 4N2, Alberta, Canada.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3551-1']
764,29781068,Pelvic Floor Muscle Training With Or Without Tibial Nerve Stimulation and Lifestyle Changes Have Comparable Effects on The Overactive Bladder. A Randomized Clinical Trial.,"PURPOSE


To compare effects of transcutaneous posterior tibial nerve stimulation (TPTNS) and pelvic floor muscle training (PFMT) in women with overactive bladder syndrome (OAB).
MATERIAL AND METHODS


We randomized 67 women ? 18 years with OAB to three parallel groups: group I (n = 22) received life-style recommendations (LSR) only; group II (n = 24) had LSR + PFMT and group III (n = 21) had LSR + PFMT + TPTNS. Urgency, evaluated by a 3-day voiding diary before treatment and six weeks later, was the main outcome measure. The King's College Health Questionnaire was also administered.
RESULTS


Urgency was significantly reduced in all three groups from 5.1 ± 3.7 to 3.8 ± 3.2 episodes/day, P = .016 in group I, from 5.2 ± 3.6 to 3.2 ± 2.9, P = .006 in group II and from 6.8 ± 3.1 to 4.4 ± 3.5 in group III, P = .013. There were no intergroup differences. The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences. Womenimproved their micturition frequency in two groups from 8.9 ± 3.2 to 7.5 ± 2.3 episodes/per day, P = .025 in group II, and from 8.8 ± 2.3 to 7.4 ± 2.0, P = .001 in group III, but only in group II was a significant reduction of urinary incontinence seen from 3.8 ± 4.6 to 2.9 ± 4.8 episodes/day, P = .045.
CONCLUSION


All three treatments lead to effective short-term reduction of urgency in women with OAB, but longterm efficacy evaluation is required.",2018,"The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences.","['We randomized 67 women ', 'women with OAB', '18 years with OAB', 'women with overactive bladder syndrome (OAB']","['LSR + PFMT + TPTNS', 'LSR + PFMT', 'Pelvic Floor Muscle Training With Or Without', 'transcutaneous posterior tibial nerve stimulation (TPTNS) and pelvic floor muscle training (PFMT', 'life-style recommendations (LSR']","['Urgency', 'urinary incontinence', '3-day voiding diary', 'general health perception, role limitation, physical and social limitations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",67.0,0.0247262,"The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bykoviene', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, Kaunas, Lithuania. lina.bykoviene@lsmuni.lt.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Aniuliene', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Bartuseviciene', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Arnoldas', 'Initials': 'A', 'LastName': 'Bartusevicius', 'Affiliation': 'Department of Obstetrics and Gynecology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Urology journal,['10.22037/uj.v0i0.4169']
765,29681046,Long-term Effect of Colchicine Treatment in Preventing Urethral Stricture Recurrence After Internal Urethrotomy.,"PURPOSE


Urethral stricture, known as a scar formation leading to urethral lumen stricture in sub-epithelial tissue, is the most common late complication of transurethral prostate resection (TURP). The aim of study is to evaluate efficacy of colchicine treatment in preventing urethral stricture recurrence in patients after internal urethrotomy, and to determine whether colchicine treatment had a sustained effect in decreasing stricture recurrences in patients with concomitant diseases.
METHODS


Patient data with weak urine stream and/or voiding difficulty, and who had internal urethrotomy in Urology Department of Maltepe University Hospital between dates 01 January 2011 and December 2016 were collected. They were randomized to colchicine receiving, and non-receiving arms. Colchicine was given 1 g/day orally for two months, and primary efficacy point was defined as urethral stricture development in 3, 6, and 12 months after internal urethrotomy.
RESULTS


The study was conducted on 84 males with the mean age of 67.7 ± 7.5 years. The mean ages of colchicine receivers and non-receivers were 68.2 ± 7.6 and 67.1 ± 7.6 years, respectively. Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers. In overall evaluation, recurrence rate of urethral stricture was significantly low, if there was only one comorbidity (P = .006), but rates were significantly higher in presence of three (P = .010) and four (P = .040) comorbidities. No significant difference in recurrencerates was determined in patients without comorbidities or with two comorbidities (P > .05).
CONCLUSION


Combination of oral colchicine with internal urethrotomy reduces recurrence rates of urethral stricturesignificantly.",2018,Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers.,"['Patient data with weak urine stream and/or voiding difficulty, and who had internal urethrotomy in Urology Department of Maltepe University Hospital between dates 01 January 2011 and December 2016 were collected', 'patients after internal urethrotomy', 'patients with concomitant diseases', '84 males with the mean age of 67.7 ± 7.5 years']","['Colchicine', 'transurethral prostate resection (TURP', 'colchicine']","['stricture recurrences', 'recurrence rates of urethral stricturesignificantly', 'urethral stricture recurrence', 'Recurrence rate of urethral stricture', 'Urethral Stricture Recurrence', 'recurrence rate of urethral stricture', 'urethral stricture development', 'recurrencerates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C0241705', 'cui_str': 'Painful urging to urinate (finding)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0587531', 'cui_str': 'Urology department (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0243087', 'cui_str': 'concomitant disease'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",84.0,0.0246675,Recurrence rate of urethral stricture was significantly lower in colchicine receivers (P = .044) than non-receivers.,"[{'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Sinanoglu', 'Affiliation': 'Urology Department, Maltepe University Faculty of Medicine, Istanbul Turkey. orhundr@hotmail.com.'}, {'ForeName': 'Fatih Osman', 'Initials': 'FO', 'LastName': 'Kurtulus', 'Affiliation': 'Urology Clinic Kolan Hospital, Istanbul Turkey.'}, {'ForeName': 'Feride Sinem', 'Initials': 'FS', 'LastName': 'Akgün', 'Affiliation': 'Emergency Department, Maltepe University Faculty of Medicine, Istanbul Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4198']
766,27942857,Sustainable impact of an individualized exercise program on physical activity level and fatigue syndrome on breast cancer patients in two German rehabilitation centers.,"PURPOSE


Although physical activity has been demonstrated to increase cancer survival in epidemiological studies, breast cancer patients tend toward inactivity after treatment.
METHODS


Breast cancer patients were quasi-randomly allocated to two different groups, intervention (IG) and control (CG) groups. The intervention group (n = 111) received an individual 3-week exercise program with two additional 1-week inpatient stays after 4 and 8 months. At the end of the rehabilitation, a home-based exercise program was designed. The control group (n = 83) received a 3-week rehabilitation program and did not obtain any follow-up care. Patients from both groups were measured using questionnaires on physical activity, fatigue, and quality of life (QoL) at five time points, 4 months (t1), 8 months (t2), 12 months (t3), 18 months (t4), and 24 months (t5) after the beginning of the rehabilitation.
RESULTS


After 2 years, the level of physical activity (total metabolic rate) increased significantly from 2733.16 ± 2547.95 (t0) to 4169.71 ± 3492.27 (t5) metabolic equivalent (MET)-min/week in the intervention group, but just slightly changed from 2858.38 ± 2393.79 (t0) to 2875.74 ± 2590.15 (t5) MET-min/week in the control group (means ± standard deviation). Furthermore, the internal group comparison showed significant differences after 2 years as well. These results came along with a significantly reduced fatigue syndrome and an increased health-related quality of life.
CONCLUSIONS


The data indicate that an individual, according to their preferences, and physical-resource-adapted exercise program has a more sustainable impact on the physical activity level in breast cancer patients than the usual care. It is suggested that the rehabilitation program should be personalized for all breast cancer patients.",2017,The control group (n = 83) received a 3-week rehabilitation program and did not obtain any follow-up care.,"['breast cancer patients in two German rehabilitation centers', 'breast cancer patients', 'Breast cancer patients', 'breast cancer patients than the usual care']","['intervention (IG) and control (CG', 'individualized exercise program', 'individual 3-week exercise program', '3-week rehabilitation program and did not obtain any follow-up care']","['level of physical activity (total metabolic rate', 'fatigue syndrome', 'cancer survival', 'physical activity level and fatigue syndrome', 'physical activity, fatigue, and quality of life (QoL', 'health-related quality of life']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0130039,The control group (n = 83) received a 3-week rehabilitation program and did not obtain any follow-up care.,"[{'ForeName': 'Freerk T', 'Initials': 'FT', 'LastName': 'Baumann', 'Affiliation': 'Department 1 of Internal Medicine, Center for Integrated Oncology Köln Bonn University Clinic of Cologne, Kerpenerstraße 62, 50937, Cologne, Germany. freerk.baumann@uk-koeln.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bieck', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Oberste', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Kuhn', 'Affiliation': 'Rehabilitation Center, ""Klinik Am Kurpark"", Bad Kissingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'Rehabilitation Center, ""Klinik Am Kurpark"", Bad Kissingen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wentrock', 'Affiliation': 'Rehabilitation Center, ""Klinik Am Kurpark"", Bad Kissingen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Zopf', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schüle', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reuss-Borst', 'Affiliation': 'Facharztpraxis am Rehabilitations- und Präventionszentrum, Bad Bocklet, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3490-x']
767,27966023,"Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.","PURPOSE


High-dose chemotherapy prior to autologous stem cell transplantation (ASCT) leads to adverse effects including mucositis, neutropenia and bacteremia. To reduce the toxicity, we treated myeloma and lymphoma patients with peroral bismuth as an adjuvant to chemotherapy to convey cytoprotection in non-malignant cells.
METHODS


This trial was a prospective, randomised, double-blind, placebo-controlled pilot study of hematological inpatients (n = 50) receiving bismuth or placebo tablets, in order to identify any potential superiority of bismuth on toxicity from chemotherapy.
RESULTS


We show for the first time that bismuth significantly reduces grade 2 stomatitis, febrile neutropenia and infections caused by melphalan in multiple myeloma, where adverse effects also were significantly linked to gender. In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo. Also, lymphoma patients' adverse effects were linked to gender. For the first time, bismuth is demonstrated as a safe strategy against chemotherapy's toxicity without interfering with intentional anti-cancer efficiency. Also, we show how gender significantly influences various adverse effects and response to treatment in both multiple myeloma and malignant lymphomas.
CONCLUSION


These results may impact clinical prevention of chemotherapy's cytotoxicity in certain patient groups, and also, this study may direct further attention towards the impact of gender during the course and treatment outcome of malignant disorders.",2017,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","['hematological inpatients (n\xa0=\xa050) receiving', 'patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation']","['bismuth or placebo tablets', 'Bismuth adjuvant', 'placebo', 'autologous stem cell transplantation (ASCT', 'peroral bismuth']","['toxicity', 'mucositis, neutropenia and bacteremia', 'diarrhoea', 'grade 2 stomatitis, febrile neutropenia and infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",50.0,0.265311,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","[{'ForeName': 'Per Boye', 'Initials': 'PB', 'LastName': 'Hansen', 'Affiliation': 'Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Penkowa', 'Affiliation': 'Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3522-6']
768,27995318,Nausea and disturbed sleep as predictors of cancer-related fatigue in breast cancer patients: a multicenter NCORP study.,"PURPOSE


Cancer-related fatigue (CRF) is a prevalent and distressing side effect of cancer and its treatment that remains inadequately understood and poorly managed. A better understanding of the factors contributing to CRF could result in more effective strategies for the prevention and treatment of CRF. The objectives of this study were to examine the prevalence, severity, and potential predictors for the early onset of CRF after chemotherapy cycle 1 in breast cancer patients.
METHODS


We report on a secondary data analysis of 548 female breast cancer patients from a phase III multi-center randomized controlled trial examining antiemetic efficacy. CRF was assessed by the Brief Fatigue Inventory at pre- and post-chemotherapy cycle 1 as well as by the four-day diary.
RESULTS


The prevalence of clinically relevant post-CRF was 75%. Linear regression showed that pre-treatment CRF, greater nausea, disturbed sleep, and younger age were significant risk factors for post-CRF (adjusted R 2  = 0.39; P < 0.0001). Path modeling showed that nausea severity influenced post-CRF both directly and indirectly by influencing disturbed sleep. Similarly, pre-treatment CRF influenced post-CRF directly as well as indirectly through both nausea severity and disturbed sleep. Pearson correlations showed that changes in CRF over time were significantly correlated with concurrent changes in nausea severity (r = 0.41; P < 0.0001) and in disturbed sleep (r = 0.20; P < 0.0001).
CONCLUSION


This study showed a high prevalence (75%) of clinically relevant CRF in breast cancer patients following their initial chemotherapy, and that nausea severity, disturbed sleep, pre-treatment CRF, and age were significant predictors of symptom.",2017,"Linear regression showed that pre-treatment CRF, greater nausea, disturbed sleep, and younger age were significant risk factors for post-CRF (adjusted R 2  = 0.39; P < 0.0001).","['breast cancer patients', '548 female breast cancer patients from a phase III multi-center']",[],"['nausea, disturbed sleep', 'CRF', 'Nausea and disturbed sleep', 'nausea severity and disturbed sleep', 'nausea severity', 'disturbed sleep']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",548.0,0.0502666,"Linear regression showed that pre-treatment CRF, greater nausea, disturbed sleep, and younger age were significant risk factors for post-CRF (adjusted R 2  = 0.39; P < 0.0001).","[{'ForeName': 'Anita R', 'Initials': 'AR', 'LastName': 'Peoples', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA. Anita_Peoples@urmc.rochester.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Roscoe', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Block', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, 265 Crittenden Blvd., Rochester, NY, 14642, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Ryan', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY, 14642, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Janelsins', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Peppone', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Dennis F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Wichita NCORP, Wichita, KS, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Coles', 'Affiliation': 'Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, MN, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Hoelzer', 'Affiliation': 'Heartland Cancer Research NCORP, Decatur, IL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Dozier', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, 265 Crittenden Blvd., Rochester, NY, 14642, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3520-8']
769,30580652,Effects of Curcumin on the Oxidative Stress Response to a Dual Stress Challenge in Trained Men.,"Firefighters and military personnel are exposed to a variety of stressors. The combination of mental and physical stress (i.e., dual stress challenges [DSCs]) results in significant oxidative stress (OS), which may contribute to cardiometabolic dysfunction. Curcumin (CUR) is an exogenous antioxidant that may attenuate such OS. Fourteen trained men participated in a randomized, cross-over design to investigate the impact of CUR on markers of OS resulting from DSC. CUR or placebo was ingested three days prior to, and the morning of, testing. The DSC involved 20 min of mental stress challenges during 35 min of cycling at 60% V̇O 2 peak . Blood was sampled before, as well as immediately, 30 min, and 60 min after, exercise and analyzed for glutathione (GSH), superoxide dismutase (SOD), hydrogen peroxide (H 2 O 2 ), and advanced oxidation protein products (AOPP). There was no treatment effect for any variable. However, the DSC resulted in significant reductions in SOD, H 2 O 2 , and AOPP at 30 and 60 min after exercise. Previous studies have shown that DSC results in significant OS compared to exercise alone. However, these data suggest the DSC was associated with reductions in postexercise markers of OS. Antioxidant therapy is likely not needed in trained men exposed to DSC.",2020,"However, the DSC resulted in significant reductions in SOD, H 2 O 2 , and AOPP at 30 and 60 min after exercise.","['Fourteen trained men participated', 'Trained Men']","['CUR or placebo', 'Curcumin (CUR', 'Curcumin', 'DSC', 'Antioxidant therapy']","['glutathione (GSH), superoxide dismutase (SOD), hydrogen peroxide (H 2 O 2 ), and advanced oxidation protein products (AOPP', 'Oxidative Stress Response', 'postexercise markers of OS', 'SOD, H 2 O 2 , and AOPP']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1879713', 'cui_str': 'Antioxidant therapy'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",,0.0621846,"However, the DSC resulted in significant reductions in SOD, H 2 O 2 , and AOPP at 30 and 60 min after exercise.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McAllister', 'Affiliation': 'Department of Health and Human Performance, Texas State University, San Marcos, TX, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Basham', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Mississippi, MS, USA.'}, {'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Mississippi, MS, USA.'}, {'ForeName': 'JohnEric W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Mississippi, MS, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Butawan', 'Affiliation': 'School of Health Studies, The University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'School of Health Studies, The University of Memphis, Memphis, TN, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2018.1515142']
770,27885469,"NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron.","PURPOSE


Antiemetic guidelines recommend co-administration of targeted prophylactic medications inhibiting molecular pathways involved in emesis. NEPA is a fixed oral combination of a new NK 1  receptor antagonist (RA), netupitant (NETU 300 mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT 3  RA. NEPA showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) compared with oral PALO in a single chemotherapy cycle; maintenance of efficacy/safety over continuing cycles is the objective of this study.
METHODS


This study is a multinational, double-blind study comparing a single oral dose of NEPA vs oral PALO in chemotherapy-naïve patients receiving anthracycline/cyclophosphamide-based chemotherapy along with dexamethasone 12 mg (NEPA) or 20 mg (PALO) on day 1. The primary efficacy endpoint was delayed (25-120 h) complete response (CR: no emesis, no rescue medication) in cycle 1. Sustained efficacy was evaluated during the multicycle extension by calculating the proportion of patients with overall (0-120 h) CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles.
RESULTS


Of 1455 patients randomized, 1286 (88 %) participated in the multiple-cycle extension for a total of 5969 cycles; 76 % completed ≥4 cycles. The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1-4 (74.3 vs 66.6 %, 80.3 vs 66.7 %, 83.8 vs 70.3 %, and 83.8 vs 74.6 %, respectively; p ≤ 0.001 each cycle). The cumulative percentage of patients with a sustained CR over all 4 cycles was also greater for NEPA (p < 0.0001). NEPA was well tolerated over cycles.
CONCLUSIONS


NEPA, a convenient, guideline-consistent, fixed antiemetic combination is effective and safe over multiple cycles of chemotherapy.",2017,The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1-4,"['1455 patients randomized, 1286 (88\xa0%) participated in the multiple-cycle extension for a total of 5969\xa0cycles; 76\xa0% completed ≥4\xa0cycles', 'chemotherapy-naïve patients receiving']","['chemotherapy', 'NEPA', 'oral palonosetron', 'NEPA vs oral PALO', 'oral PALO', 'anthracycline/cyclophosphamide-based chemotherapy along with dexamethasone 12\xa0mg (NEPA) or 20\xa0mg (PALO']","['overall CR', 'nausea and vomiting (CINV', 'Sustained efficacy', 'delayed (25-120\xa0h) complete response (CR: no emesis, no rescue medication', 'efficacy/safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1455.0,0.12708,The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1-4,"[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': ""Clinique de Genolier, Institut Multidisciplinaire d'Oncologie, Case Postale (P.O. Box) 100, Route du Muids 3, 1272, Genolier, Switzerland. maapro@genolier.net.""}, {'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Hematology and Oncology, Staedt Klinikum Neuperlach and Harlaching, Munich, Germany.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'The West Clinic, Memphis,, TN, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Sarosiek', 'Affiliation': 'NZOZ Magodent, Warsaw, Poland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Oprean', 'Affiliation': 'Oncomed SRL, Timisoara, Romania.'}, {'ForeName': 'Servando', 'Initials': 'S', 'LastName': 'Cardona-Huerta', 'Affiliation': 'Universidad Autonoma de Nuevo Leon, Monterrey, Mexico.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Hansen', 'Affiliation': 'Northern Utah Associates, Ogden,, UT, USA.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3502-x']
771,30193565,The effect of education through mobile phone short message service on promoting self-care in pre-diabetic pregnant women: A randomized controlled trial.,"INTRODUCTION


Gestational diabetes is increasing in developed and developing countries. This study aimed to evaluate the effect of SMS messaging on the self-care among pre-diabetic pregnant women.
METHODS


This randomized controlled trial conducted on 100 pre-diabetic pregnant women referred to Ahvaz Health Centers, Iran, Sep to Dec, 2016. Women were randomly assigned into the face to face education group and short message systems in addition to the face to face education group. Self-care variables were compared between the groups. Data was analyzed using chi-square, independent and paired t-tests.
RESULTS


There was no difference regard to FBG and OGTT, but there was a significant difference between groups in physical activity level ( P <0.001) and in all food groups except bread and cereals after the intervention ( P <0.05).
CONCLUSION


The education through a short text message system seem couldn't control the blood sugar, but it could promote physical activity and food additives of pre-diabetic pregnant women.",2020,"There was no difference regard to FBG and OGTT, but there was a significant difference between groups in physical activity level ( P<0.001) and in all food groups except bread and cereals after the intervention ( P<0.05).","['pre-diabetic pregnant women', '100 pre-diabetic pregnant women referred to Ahvaz Health Centers, Iran, Sep to Dec, 2016']","['education through mobile phone short message service', 'SMS messaging', 'face to face education group and short message systems in addition to the face to face education group']",['physical activity level'],"[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178909'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.109961,"There was no difference regard to FBG and OGTT, but there was a significant difference between groups in physical activity level ( P<0.001) and in all food groups except bread and cereals after the intervention ( P<0.05).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abbaspoor', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Amani', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Poorandokht', 'Initials': 'P', 'LastName': 'Afshari', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jafarirad', 'Affiliation': 'Department of Nutrition, School of Para-medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18791419']
772,30476343,Feasibility and acceptability of a faith-based mind-body intervention among African American adults.,"Physical activity reduces cancer risk, yet African American adults remain insufficiently active, contributing to cancer health disparities. Harmony & Health (HH) was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality of life among a church-based sample of overweight/obese, insufficiently active African American adults. Men and women were recruited to the study through an existing church partnership. Eligible participants (N = 50) were randomized to a movement-based mind-body intervention (n = 26) or waitlist control (n = 24). Participants in the intervention attended 16 mind-body sessions over 8 weeks and completed a physical assessment, questionnaires on moderate-to-vigorous physical activity (MVPA) and psychosocial factors, and accelerometry at baseline (T1), post-intervention (T2), and 6 week follow-up (T3). Eighty percent of participants (94% women, M age = 49.7 ± 9.4 years, M body mass index = 32.8 ± 5.2 kg/m2) completed the study, and 61.5% of intervention participants attended ≥10 mind-body sessions. Participants self-reported doing 78.8 ± 102.9 (median = 40.7, range: 0-470.7) min/day of MVPA and did 27.1 ± 20.7 (median = 22.0, range: 0-100.5) min/day of accelerometer-measured MVPA at baseline. Trends suggest that mind-body participants self-reported greater improvements in physical activity and psychosocial well-being from baseline to post-intervention than waitlist control participants. HH is feasible and acceptable among African American adults. Trends suggest that the mind-body intervention led to improvements in physical activity and psychosocial outcomes. This study extends the literature on the use of mind-body practices to promote physical and psychological health and reduce cancer disparities in African American adults.",2020,Trends suggest that mind-body participants self-reported greater improvements in physical activity and psychosocial well-being from baseline to post-intervention than waitlist control participants.,"['church-based sample of overweight/obese, insufficiently active African American adults', 'Eighty percent of participants (94% women, M age = 49.7 ± 9.4 years, M body mass index = 32.8 ± 5.2 kg/m2) completed the study, and 61.5% of intervention participants attended ≥10 mind-body sessions', 'Men and women were recruited to the study through an existing church partnership', 'Eligible participants (N = 50', 'African American adults']","['movement-based mind-body intervention', 'HH', 'waitlist control', 'faith-based mind-body intervention']","['Feasibility and acceptability', 'physical activity and psychosocial', 'physical activity and psychosocial outcomes']","[{'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",50.0,0.0302913,Trends suggest that mind-body participants self-reported greater improvements in physical activity and psychosocial well-being from baseline to post-intervention than waitlist control participants.,"[{'ForeName': 'Scherezade K', 'Initials': 'SK', 'LastName': 'Mama', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Nishat', 'Initials': 'N', 'LastName': 'Bhuiyan', 'Affiliation': 'Department of Kinesiology, College of Health and Human Development, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chaoul', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Fagundes', 'Affiliation': 'Department of Psychology, Rice University, Houston, TX, USA.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Hoover', 'Affiliation': 'Department of Health Disparities Research, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Larkin L', 'Initials': 'LL', 'LastName': 'Strong', 'Affiliation': 'Department of Health Disparities Research, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nga T', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'Department of Health Disparities Research, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby114']
773,23407222,The pharmacokinetics of nevirapine when given with isoniazid in South African HIV-infected individuals.,"Isoniazid preventive therapy (IPT) is recommended in patients on antiretroviral treatment. Isoniazid (INH) inhibits CYP3A4, which metabolises nevirapine (NVP). Administration of INH may cause higher NVP concentrations and toxicity. We studied the effect of INH on NVP concentrations  in 21 patients randomised to either placebo (n = 13) or INH (n = 8) in an ongoing trial of IPT in patients on ART. INH was associated with a 24% increase in median NVP area under the plasma concentration-time curve for the 12 h dosing interval, which was not statistically significant  (P = 0.66).",2013,"INH was associated with a 24% increase in median NVP area under the plasma concentration-time curve for the 12 h dosing interval, which was not statistically significant  (P = 0.66).","['South African HIV-infected individuals', 'n = 13) or', 'patients on antiretroviral treatment', '21 patients randomised to either']","['nevirapine (NVP', 'Isoniazid (INH', 'Isoniazid preventive therapy (IPT', 'placebo', 'IPT', 'nevirapine', 'INH', 'isoniazid']","['median NVP area under the plasma concentration-time curve', 'NVP concentrations and toxicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.08662,"INH was associated with a 24% increase in median NVP area under the plasma concentration-time curve for the 12 h dosing interval, which was not statistically significant  (P = 0.66).","[{'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Decloedt', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Groote Schuur Hospital University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mwansa-Kambafwile', 'Affiliation': ''}, {'ForeName': 'J-S', 'Initials': 'JS', 'LastName': 'van der Walt', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'McIlleron', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Denti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rangaka', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Wilkinson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': ''}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.12.0427']
774,30251749,The Effect of Interfascial Injection on Obturator Nerve Block Compared with Nerve Stimulating Approach by Ultrasound-Guide: A Randomized Clinical Trial.,"PURPOSE


This study was conducted to evaluate whether the ultrasound-guided interfascial injection technique is really compatible with the ultrasound-guided nerve stimulating technique for obturator nerve block (ONB) at the inguinal crease after bifurcation of the obturator nerve.
MATERIALS AND METHODS


A total 62 ONBs were performed for transurethral resection of bladder tumors under spinal anesthesia, and divided into two groups, that is, to an ultrasound-guided ONB with nerve stimulation control group (the US-NS group) or an ultrasound-guided interfascial injection experimental group (the US-IFI group). In the US-IFI group, complete ONB was confirmed using a nerve stimulator at 5 min after completing the injection, and if residual twitching remained, another local anesthetic was injected; in such cases blocks were considered to have 'failed'. During TURB surgeries, two urology assistants determined obturator reflex grade (I-IV) at 15 min after injection completion in both groups.
RESULTS


We assumed that the US-NS group achieved complete ONB in all cases. Six cases in the US-IFI group failed to achieve complete ONB (failure rate: 0% versus 19.4%, P = .012). There was one case of grade II obturator reflex in each group.
CONCLUSION


The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.",2019,The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.,[],"['Interfascial Injection', 'transurethral resection of bladder tumors under spinal anesthesia', 'Nerve Stimulating Approach by Ultrasound-Guide', 'ultrasound-guided interfascial injection technique', 'ultrasound-guided ONB with nerve stimulation control group (the US-NS group) or an ultrasound-guided interfascial injection experimental group']","['grade II obturator reflex', 'complete ONB (failure rate', 'complete ONB']",[],"[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0449623', 'cui_str': 'Nerve stimulated (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0182021', 'cui_str': 'Obturator (physical object)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",62.0,0.0215325,The ultrasound-guided interfascial injection technique was not compatible with the ultrasound-guided nerve stimulating technique for ONB at the inguinal crease.,"[{'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea. fred0314@gilhospital.com.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Hyeon Ju', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Su Bin', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",Urology journal,['10.22037/uj.v0i0.4386']
775,31584231,Evaluation of the effect of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial.,"Drugs that inhibit the sodium-glucose co-transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new-onset heart failure events by ≈30%. In addition, in the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti-hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR-Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin-angiotensin system and neprilysin, beta-blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high-risk patients. A large proportion of the participants is expected to have an ejection fraction < 30%, and the estimated annual event rate is expected to be at least 15%. The EMPEROR-Reduced trial is well-positioned to determine if the addition of empagliflozin can add meaningfully to current approaches that have established benefits in the treatment of chronic heart failure with left ventricular systolic dysfunction.",2019,"The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events.","['patients with established heart failure, including those without diabetes', 'patients with heart failure', 'chronic heart failure with left ventricular systolic dysfunction', '≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤\u200940%), half of whom are expected not to have diabetes', 'patients with type 2 diabetes', 'patients with chronic heart failure and a reduced ejection fraction']","['placebo or empagliflozin', 'SGLT2 inhibitors', 'empagliflozin, canagliflozin and dapagliflozin', 'sodium-glucose co-transporter 2 inhibition with empagliflozin', 'empagliflozin']","['time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure', 'morbidity and mortality', 'heart failure', 'risk of both pump failure and sudden deaths', 'renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",,0.0677547,"The primary endpoint is the time-to-first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all-cause mortality, and recurrent hospitalization events.","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Salsali', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Boehringer Ingelheim Canada Ltd., Burlington, Canada.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site, Berlin, Germany, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Inserm INI-CRCT, CHRU, Université de Lorraine, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1536']
776,30340060,Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.,"BACKGROUND


Interventions to improve physical and psychological outcomes in recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners are largely unstudied, though likely to have a major impact on adjustment to the ICD and general well-being.
OBJECTIVE


The purpose of this study was to report the primary outcomes of the patient plus partner randomized controlled trial.
METHODS


In a 2-group (N = 301) prospective randomized controlled trial, we compared 2 social-cognitive-based intervention programs-patient plus partner (P+P) and patient only (P only)-implemented after initial ICD implantation. The patient intervention, consisting of educational materials, nurse-delivered telephone coaching, videotape demonstrations, and access to a nurse via a 24/7 pager, was implemented in both groups. P+P also incorporated partner participation. The primary patient outcomes were symptoms and anxiety at 3 months. Other outcomes were physical function (SF-36 [Short Form 36] and ICD shocks-patient), psychological adjustment (PHQ-9 [Patient Health Questionaire-9]), relationship impact (Dyadic Adjustment Scale and Oberst Caregiving Burden Scale (DAS and OCBS) partner), self-efficacy and knowledge (Sudden Cardiac Arrest-Self Efficacy [SCA-SE], Sudden Cardiac Arrest-Outcomes Expectation [SCA-OE], and Knowledge Self-Assessment [KSA]), and health care utilization (outpatient visits and hospitalizations) at hospital discharge and 1, 3, 6, and 12 months post-ICD implantation.
RESULTS


For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07). For partners, P+P was more effective in improving partner caregiver burden (P = .002), self-efficacy (P = .001), and ICD knowledge (P = .04).
CONCLUSION


An intervention that integrated the partner into the patient's recovery after an ICD improved outcomes for both. Beyond survival benefits of the ICD, intervention programs designed to address both the patient and their partner living successfully with an ICD are needed and promising.",2019,"For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07).","['Patient plus partner trial', 'recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners']","['initial implantable cardioverter-defibrillator', '2 social-cognitive-based intervention programs-patient plus partner (P+P) and patient only (P only)-implemented after initial ICD implantation']","['partner caregiver burden', 'symptoms and anxiety', 'depression', 'ICD knowledge', 'improving symptoms', 'self-efficacy', 'physical function (SF-36 [Short Form 36] and ICD shocks-patient), psychological adjustment (PHQ-9 [Patient Health Questionaire-9]), relationship impact (Dyadic Adjustment Scale and Oberst Caregiving Burden Scale (DAS and OCBS) partner), self-efficacy and knowledge (Sudden Cardiac Arrest-Self Efficacy [SCA-SE], Sudden Cardiac Arrest-Outcomes Expectation [SCA-OE], and Knowledge Self-Assessment [KSA]), and health care utilization (outpatient visits and hospitalizations) at hospital discharge and 1, 3, 6, and 12 months post-ICD implantation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C1720824', 'cui_str': 'Sudden Cardiac Arrest'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",,0.0621888,"For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07).","[{'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington. Electronic address: cindyd@uw.edu.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Psychosocial and Community Health, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': 'Division of Cardiology, University of Washington School of Medicine, Seattle, Washington.'}]",Heart rhythm,['10.1016/j.hrthm.2018.10.011']
777,31652237,Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes.,"INTRODUCTION


This study examines the role of nutritional status during exercise training in patients with type 2 diabetes mellitus by investigating the effect of endurance-type exercise training in the fasted versus the fed state on clinical outcome measures, glycemic control, and skeletal muscle characteristics in male type 2 diabetes patients.
METHODS


Twenty-five male patients (glycated hemoglobin (HbA1c), 57 ± 3 mmol·mol (7.4% ± 0.3%)) participated in a randomized 12-wk supervised endurance-type exercise intervention, with exercise being performed in an overnight-fasted state (n = 13) or after consuming breakfast (n = 12). Patients were evaluated for glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression.
RESULTS


Exercise training was well tolerated without any incident of hypoglycemia. Exercise training significantly decreased whole-body fat mass (-1.6 kg) and increased high-density lipoprotein concentrations (+2 mg·dL), physical fitness (+1.7 mL·min·kg), and fat oxidation during exercise in both groups (PTIME < 0.05), with no between-group differences (PTIME × GROUP > 0.05). HbA1c concentrations significantly decreased after exercise training (PTIME < 0.001), with a significant greater reduction after consuming breakfast (-0.30% ± 0.06%) compared with fasted state (-0.08% ± 0.06%; mean difference, 0.21%; PTIME × GROUP = 0.016). No interaction effects were observed for skeletal muscle genes related to lipid metabolism or oxidative capacity.
CONCLUSIONS


Endurance-type exercise training in the fasted or fed state do not differ in their efficacy to reduce fat mass, increase fat oxidation capacity, and increase cardiorespiratory fitness and high-density lipoprotein concentrations or their risk of hypoglycemia in male patients with type 2 diabetes. HbA1c seems to be improved more with exercise performed in the postprandial compared with the postabsorptive state.",2020,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","['Twenty-five male patients (HbA1c 57±3 mmol/mol (7.4±0.3%)) participated in a randomized 12-week', 'male patients with type 2 diabetes', 'male type 2 diabetes patients', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes']","['Exercise-Nutritional State Interactions', 'FastEx', 'endurance-type exercise training', 'Exercise training', 'supervised endurance-type exercise intervention, with exercise being performed in an overnight fasted state (FastEx, n=13) or after consuming breakfast (FedEx', 'Endurance-type exercise training', 'exercise training']","['HDL concentrations (+2mg*dL), physical fitness (+1.7mL*min*kg) and fat oxidation during exercise', 'whole-body fat mass', 'glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression', 'lipid metabolism or oxidative capacity', 'Glycated haemoglobin', 'cardiorespiratory fitness and HDL concentrations', 'HbA1c concentrations', 'FedEx', 'tolerated without any incident of hypoglycemia']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",25.0,0.0307651,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Verboven', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Wens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vandenabeele', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Stevens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Celie', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dendale', 'Affiliation': 'Heart Centre Hasselt, Jessa Hospital, Hasselt, BELGIUM.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, NETHERLANDS.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Calders', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hansen', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002165']
778,30345345,Effectiveness of a Community Health Worker-Led Diabetes Intervention among Older and Younger Latino Participants: Results from a Randomized Controlled Trial.,"Diabetes management for older Latino adults is complex, given a higher incidence of multiple coexisting medical conditions and psychosocial barriers to self-management. Community health workers (CHWs) may be effective in reducing these barriers. The REACH Detroit CHW randomized controlled intervention studies with Latino/as with diabetes found improvements in self-management behaviors and glucose control after participating in a CHW-led intervention. Using data from the REACH Detroit Partnership's cohort 3, this study used descriptive statistics and multiple linear regression analyses to evaluate whether the six-month CHW intervention had a greater effect on older Latino/as (ages 55 and older) than younger participants between baseline and post-intervention follow-up at six months. There were significant intervention effects by age group that varied by outcome. Compared to a control group that received enhanced usual care, there were statistically significant intervention effects demonstrating greater self-efficacy scores 1.27 (0.23, 2.32);  p  < 0.05, and reductions in HbA1c 1.02 (-1.96,-0.07);  p  < 0.05, among older participants in the CHW intervention, and increases in diabetes support 0.74 (0.34, 1.13);  p  < 0.001; and understanding of diabetes management 0.39 (0.08, 0.70);  p  < 0.01 among younger participants.",2018,"Compared to a control group that received enhanced usual care, there were statistically significant intervention effects demonstrating greater self-efficacy scores 1.27 (0.23, 2.32);  p  < 0.05, and reductions in HbA1c 1.02 (-1.96,-0.07);  ","['Community health workers (CHWs', 'Older and Younger Latino Participants', 'older Latino adults']",['Community Health Worker-Led Diabetes Intervention'],['self-efficacy scores'],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0294726,"Compared to a control group that received enhanced usual care, there were statistically significant intervention effects demonstrating greater self-efficacy scores 1.27 (0.23, 2.32);  p  < 0.05, and reductions in HbA1c 1.02 (-1.96,-0.07);  ","[{'ForeName': 'Barbara Mendez', 'Initials': 'BM', 'LastName': 'Campos', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Edith C', 'Initials': 'EC', 'LastName': 'Kieffer', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Sinco', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Palmisano', 'Affiliation': 'Community Health and Social Services (CHASS), Detroit, MI 48209, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Spencer', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Piatt', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics3030047']
779,31601935,Additional Expiratory Resistance Elevates Airway Pressure and Lung Volume during High-Flow Tracheal Oxygen via Tracheostomy.,"The standard high-flow tracheal (HFT) interface was modified by adding a 5-cm H 2 O/L/s resistor to the expiratory port. First, in a test lung simulating spontaneous breathing, we found that the modified HFT caused an elevation in airway pressure as a power function of flow. Then, three tracheal oxygen treatments (T-piece oxygen at 10 L/min, HFT and modified HFT at 40 L/min) were delivered in a random crossover fashion to six tracheostomized pigs before and after the induction of lung injury. The modified HFT induced a significantly higher airway pressure compared with that in either T-piece or HFT (p < 0.001). Expiratory resistance significantly increased during modified HFT (p < 0.05) to a mean value of 4.9 to 6.7 cm H 2 O/L/s. The modified HFT induced significant augmentation in end-expiratory lung volume (p < 0.05) and improved oxygenation for lung injury model (p = 0.038) compared with the HFT and T-piece. There was no significant difference in esophageal pressure swings, transpulmonary driving pressure or pressure time product among the three treatments (p > 0.05). In conclusion, the modified HFT with additional expiratory resistance generated a clinically relevant elevation in airway pressure and lung volume. Although expiratory resistance increased, inspiratory effort, lung stress and work of breathing remained within an acceptable range.",2019,"There was no significant difference in esophageal pressure swings, transpulmonary driving pressure or pressure time product among the three treatments (p > 0.05).",[],"['tracheal oxygen treatments (T-piece oxygen at 10\u2009L/min, HFT and modified HFT']","['airway pressure', 'Expiratory resistance', 'oxygenation for lung injury model', 'inspiratory effort, lung stress and work of breathing', 'airway pressure and lung volume', 'esophageal pressure swings, transpulmonary driving pressure or pressure time product', 'Additional Expiratory Resistance Elevates Airway Pressure and Lung Volume', 'end-expiratory lung volume']",[],"[{'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}]",,0.0231436,"There was no significant difference in esophageal pressure swings, transpulmonary driving pressure or pressure time product among the three treatments (p > 0.05).","[{'ForeName': 'Guang-Qiang', 'Initials': 'GQ', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiu-Mei', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Ran', 'Initials': 'JR', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Cheng', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Lin', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. zhoujx.cn@icloud.com.'}]",Scientific reports,['10.1038/s41598-019-51158-0']
780,30058061,Comparison of the Efficacy of Intravenous and Intramuscular Lornoxicam for the Initial Treatment of Acute Renal Colic: A Randomized Clinical Trial.,"PURPOSE


We aimed to find out if there was any difference between intramuscular and intravenous administration of lornoxicam in terms of efficacy and side effects.
MATERIALS AND METHODS


This study was a single-blind parallel-group randomized clinical trial. A total of 51 patients who were diagnosed with acute renal colic at our clinic were included in the study. Pain severity prior to treatment was rated using the Visual Analogue Scale (VAS). Patients were randomized into 2 groups: Group 1 (n = 27) received intramuscular 8mg lornoxicam and Group 2 (n=24) received intravenous 8mg lornoxicam. Pain severity was reassessed 30 minutes after the treatment. Pre- and post-treatment VAS scores and the mean changein the VAS scores of the 2 groups were statistically compared.
RESULTS


The mean VAS scores decreased significantly from 7.65 to 2.07 in Group 1, from 7.96 to 1.38 in Group 2, and from 7.79 to 1.75 in total (P < 0.001). No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128). None of the patients suffered any side effects except for 1 (2%) patient who had dyspepsia.
CONCLUSION


Parenteral lornoxicam provides significant pain relief in patients with acute renal colic. However, no significant difference was found between intramuscular and intravenous administration in terms of analgesic efficacy.",2019,No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128).,"['51 patients who were diagnosed with acute renal colic at our clinic were included in the study', 'patients with acute renal colic', 'Acute Renal Colic']","['lornoxicam', 'intramuscular 8mg lornoxicam', 'Intravenous and Intramuscular Lornoxicam', 'intravenous 8mg lornoxicam', 'Parenteral lornoxicam']","['VAS score reduction', 'analgesic efficacy', 'Pain severity', 'mean VAS scores', 'VAS scores', 'efficacy and side effects', 'Visual Analogue Scale (VAS', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0055477', 'cui_str': 'lornoxicam'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",51.0,0.05528,No statistically significant difference was observed between Groups 1 and 2 in terms of VAS score reduction (P = 0.128).,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Soylu', 'Affiliation': 'Department of Urology, Gozde Akademi Hospital, Malatya, Turkey. drsoylu@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sarier', 'Affiliation': 'Department of Urology, Medical Park Hospital, Antalya Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Altunoluk', 'Affiliation': 'Department of Urology, Medical Palace Hospital, Kayseri, Turkey.'}, {'ForeName': 'Haluk', 'Initials': 'H', 'LastName': 'Soylemez', 'Affiliation': 'Department of Urology, Aile Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yasar Can', 'Initials': 'YC', 'LastName': 'Baydinc', 'Affiliation': 'Occupational Physician, Izmir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4496']
781,30077803,Mechanisms of change in group therapy for treatment-seeking university students.,"The present study examined mechanisms of change in dialectical behavior therapy (DBT) skills group and positive psychotherapy (PPT) group intervention, two treatments that have previously been shown to be effective at reducing symptoms of BPD and depression over a 12-week treatment protocol within the context of a college counseling center (Uliaszek et al., 2016). The present study is secondary data analysis of that trial. We hypothesized that change in dysfunctional coping skills use would be a specific mechanism for DBT, while change in functional coping skills use and therapeutic alliance would be mechanisms of change for both treatments. Fifty-four participants completed self-report and interview-based assessments at pretreatment, weeks 3, 6, 9, and posttreatment. Path models examined the predictive power of the mechanisms in predicting outcome; the moderating effect of group membership was also explored. Dysfunctional coping skills use across the course of treatment was a significant mechanism of change for BPD and depression for the DBT group, but not the PPT group. Conversely, therapeutic alliance was a significant mechanism of change for the PPT group, but not the DBT group. Findings highlight the importance of each mechanism during mid-to late-treatment specifically.",2018,"Dysfunctional coping skills use across the course of treatment was a significant mechanism of change for BPD and depression for the DBT group, but not the PPT group.",['treatment-seeking university students'],['dialectical behavior therapy (DBT) skills group and positive psychotherapy (PPT'],['BPD and depression'],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0248381,"Dysfunctional coping skills use across the course of treatment was a significant mechanism of change for BPD and depression for the DBT group, but not the PPT group.","[{'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Uliaszek', 'Affiliation': 'University of Toronto Scarborough, 1265 Military Trail, Toronto, Ontario, Canada. Electronic address: auliaszek@utsc.utoronto.ca.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hamdullahpur', 'Affiliation': 'University of Toronto Scarborough, 1265 Military Trail, Toronto, Ontario, Canada.'}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Chugani', 'Affiliation': 'University of Pittsburgh, 3420 Fifth Ave., Pittsburgh, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Tayyab Rashid', 'Affiliation': 'The Health and Wellness Centre at the University of Toronto Scarborough, 1265 Military Trail, Toronto, Ontario, Canada.'}]",Behaviour research and therapy,['10.1016/j.brat.2018.07.006']
782,31640921,Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study.,"BACKGROUND


We aimed to clinically evaluate the effect of platelet-rich plasma (PRP) therapy in patients with acute lateral ankle sprain treated with rigid immobilization.
METHODS


Patients with first-time grade II lateral ankle sprain clinically diagnosed were evaluated (n=21). A rigid immobilization was placed in all patients for ten days; previously, an application of PRP over the anterior talofibular ligament was performed in patients from the experimental group. The Visual Analogue Scale, the American Orthopedic Foot and Ankle Score, and the Foot and Ankle Disability Index were applied at 3, 5, 8 and 24 weeks of follow-up period.
RESULTS


The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks. At the end of follow-up period the results of both groups were similar.
CONCLUSIONS


A similar evolution was observed in patients treated with rigid immobilization with or without PRP after 24 weeks.
TRIAL REGISTRATION


Clinical Trials.gov with ID NCT02609308.",2020,The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks.,"['Patients with first-time grade II lateral ankle sprain clinically diagnosed were evaluated (n=21', 'patients with acute lateral ankle sprain treated with rigid immobilization']","['platelet-rich plasma (PRP) therapy', 'lateral ankle sprain with platelet-rich plasma']","['pain and better functional scores', 'Visual Analogue Scale, the American Orthopedic Foot and Ankle Score, and the Foot and Ankle Disability Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0435123,The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks.,"[{'ForeName': 'Juancarlos', 'Initials': 'J', 'LastName': 'Blanco-Rivera', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Elizondo-Rodríguez', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Simental-Mendía', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Vilchez-Cavazos', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Peña-Martínez', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Olivo', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico. Electronic address: dr.carlosacosta@gmail.com.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.09.004']
783,31651213,"Improving clinical symptoms, functioning, and quality of life in chronic schizophrenia with an integrated psychological therapy (IPT) plus emotional management training (EMT): A controlled clinical trial.","Objective:  This paper describes the results of testing a multi-component psychological therapy that includes integrated psychological therapy (IPT), together with an adaptation of emotional management therapy (EMT), versus treatment as usual (TAU), delivered in a community mental health setting for individual with chronic schizophrenia. We investigated the effectiveness of a psychological intervention on clinical symptoms, cognitive and social functioning, as well as the feasibility of treatment and its acceptance.  Method:  77 outpatients were recruited, 42 in the experimental group, who were treated with IPT + EMT, and 35 participants in control condition (TAU), both during 8 months. The subjects of both groups were assessed pre and postreatment.  Results:  Treatment attendance was 98% in experimental group and none of patients required hospital admission during therapy, meanwhile 11 patients from the TAU group withdrew and 3 were hospitalized during therapy. After therapy, patients in the experimental group compared to TAU, reduced clinical symptoms and improved cognitive functioning and quality of life.  Conclusion:  Psychological therapy seems to be a feasible intervention even in the chronic stages of the disease.",2020,"After therapy, patients in the experimental group compared to TAU, reduced clinical symptoms and improved cognitive functioning and quality of life.  ","['77 outpatients were recruited, 42 in the experimental group, who were treated with IPT\u2009+\u2009EMT, and 35 participants in control condition (TAU), both during 8 months']","['multi-component psychological therapy that includes integrated psychological therapy (IPT), together with an adaptation of emotional management therapy (EMT', 'Psychological therapy', 'integrated psychological therapy (IPT) plus emotional management training (EMT', 'psychological intervention']","['TAU, reduced clinical symptoms and improved cognitive functioning and quality of life', 'hospital admission', 'clinical symptoms, cognitive and social functioning', 'Improving clinical symptoms, functioning, and quality of life', 'Treatment attendance']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",77.0,0.020012,"After therapy, patients in the experimental group compared to TAU, reduced clinical symptoms and improved cognitive functioning and quality of life.  ","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ruiz-Iriondo', 'Affiliation': 'Mental Health and Psychiatric Assistance, Neuroscience Department, Biodonostia Health Research Institute, Gipuzkoa, Spain.'}, {'ForeName': 'Karmele', 'Initials': 'K', 'LastName': 'Salaberría', 'Affiliation': 'Mental Health and Psychiatric Assistance, Neuroscience Department, Biodonostia Health Research Institute, Gipuzkoa, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Polo-López', 'Affiliation': 'Mental Health and Psychiatric Assistance, Neuroscience Department, Biodonostia Health Research Institute, Gipuzkoa, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Iruin', 'Affiliation': 'Mental Health and Psychiatric Assistance, Neuroscience Department, Biodonostia Health Research Institute, Gipuzkoa, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Echeburúa', 'Affiliation': 'Mental Health and Psychiatric Assistance, Neuroscience Department, Biodonostia Health Research Institute, Gipuzkoa, Spain.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1683634']
784,30178449,Are Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That are Smaller than 2 cm? A Prospective Randomized Controlled Trial.,"Purpose: We aimed to evaluate whether these parameters could be guiding for us in selection between retrograde intrarenal surgery (RIRS) and mini-percutaneous nephrolithotomy (PNL) procedures in kidney stones that are smaller than 2 cm.
MATERIALS AND METHODS


The patients who had kidney stones smaller than two cm and were planned to undergo surgery were randomly distributed into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while mini-PNL group was dilated up to 16.5F and mini-PNL was per-formed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of Hounsfield unit (HU) value indicating the stone density being higher or lower than 677 and stone location on stone-free rates.
RESULTS


The study involved 60 patients including 30 in each group. The groups' preoperative values were similar. The hospitalization time and the total duration of scopy were longer in mini-PNL when the postoperative values were compared (P < .0001). In terms of stone densities, HU values that were lower than 677 in the mini-PNL group affected the stone-free rate and reduced it from 100% (> 677HU) to 55.6% (< 677HU), whereas the change was significant (P = .005). Lower calyx stones affected the RIRS results negatively, whereas multiple calyceal stones affected the mini-PNL group negatively.
CONCLUSION


Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.",2019,"Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.","['60 patients including 30 in each group', 'Kidney Stones', 'patients who had kidney stones smaller than two cm and were planned to undergo surgery']",['retrograde intrarenal surgery (RIRS) and mini-percutaneous nephrolithotomy (PNL) procedures'],"['stone densities, HU values', 'multiple calyceal stones', 'stone-free rate', 'hospitalization time and the total duration of scopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",60.0,0.02222,"Both methods had a similar success rate, but lower pole stones, multiple calyceal stones and stone density parameters affected the stone-free rates significantly, and these may be effective in treatment selection.","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Gucuk', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey. gucukadnan@hotmail.com.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Gucuk', 'Affiliation': 'Department of Family Medicine, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}, {'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Uyeturk', 'Affiliation': 'Department of Urology, Abant Izzet Baysal University Faculty of Medicine, Bolu, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4280']
785,29947248,Corrigendum.,"Goldstein E, Topitzes J, Brown RL et al. (2018) Mediational pathways of meditation and exercise on mental health and perceived stress: A randomized controlled trial.  Journal of Health Psychology.  Epub ahead of print 7 May 2018. DOI: 10.1177/1359105318772608.",2020,Journal of Health Psychology.,[],"['Mediational pathways of meditation and exercise', 'DOI']",['mental health and perceived stress'],[],"[{'cui': 'C0150277'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0753973,Journal of Health Psychology.,[],Journal of health psychology,['10.1177/1359105318784069']
786,30110179,Harsh Parenting and Violence Against Children: A Trial with Ultrapoor Families in Francophone West Africa.,"Few culturally congruent interventions are available to reduce abusive practices in families living in abject poverty in francophone West Africa. This study tests the effects of economic intervention-alone and in combination with a family-focused component-on parenting outcomes and children's reports of violence in rural Burkina Faso. Female caregivers and their 10- to 15-year-old children from 360 ultrapoor families were recruited to participate in a parallel cluster randomized control trial with 3 study arms: the waitlist (control) group, the economic intervention group (Trickle Up [TU]), and the economic intervention plus family coaching group (TU+). Effects were tested using repeated-measures mixed-effects regressions. At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's  d  = -0.57,  p  = .001) and the TU group ( d  = -0.48,  p  = .001). Changes were maintained at 24 months. TU+ caregivers also expressed more supportive parenting attitudes at 12 months compared to the control group ( d  = 0.39,  p  = .022) and the TU group ( d  = 0.55,  p  = .001). Compared to TU caregivers, caregivers in the TU+ group also reported a better quality of child-parent relationship ( d  = 0.40,  p  = .041). At 24 months, children in the TU+ group had lower odds of experiencing physical (odds ratio = 0.35,  p  = .050), 95% confidence interval [0.12, 1.00], and emotional (odds ratio = 0.52,  p  = .033), 95% confidence interval [0.28, 0.95], violence at home, compared to the control group children. The evidence suggests that involving all family members in sessions on child protection in addition to economic strengthening strategies can foster supportive parenting environments and reduce family violence among children living in ultralevel poverty in West Africa.",2020,"At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's d = -0.57, p = .001) and the TU group (d = -0.48, p = .001).","[""children's reports of violence in rural Burkina Faso"", 'children living in ultralevel poverty in West Africa', 'Harsh Parenting and Violence Against Children', 'Female caregivers and their 10- to 15-year-old children from 360 ultrapoor families']","['economic intervention plus family coaching group (TU', 'economic intervention group', 'economic intervention-alone and in combination with a family-focused component']","['quality of child-parent relationship', 'experiencing physical', 'reduced use of harsh discipline', 'supportive parenting attitudes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",360.0,0.0516571,"At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's d = -0.57, p = .001) and the TU group (d = -0.48, p = .001).","[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ismayilova', 'Affiliation': 'School of Social Service Administration, University of Chicago.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Karimli', 'Affiliation': 'Luskin School of Public Affairs, University of California Los Angeles.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1485103']
787,29981361,Using ecological momentary assessment to better understand dietary lapse types.,"Frequency of lapsing from a diet predicts weight loss failure, however previous studies have only utilized one definition of dietary lapse. No study has examined different types of lapse behaviors among individuals with overweight/obesity. The current study uses ecological momentary assessment (EMA) to examine predictors of three lapse types-eating a larger portion than intended, eating an unintended type of food, and eating at an unplanned time-in adults (N = 189; M BMI  = 36.93 ± 5.83 kg/m 2 ; 82.0% female; M age  = 51.81 ± 9.76 years) enrolled in a 12-month randomized controlled trial of two behavioral weight loss treatments. Participants completed 14 days of EMA at the start of treatment during which they indicated types of lapses that occurred with time and location of the lapse. Participants also responded to questions assessing current physical (e.g., hunger, tiredness), environmental (e.g., presence of ""delicious"" foods), and affective (e.g., loneliness, sadness) states at each prompt. Weight change was assessed at post-treatment. Separate generalized estimating equations were used to examine whether states prospectively predicted lapse occurrence at the next survey. Results indicated that lapse types differed significantly across time and location. Momentary increases in deprivation, hunger, and boredom increased likelihood of different lapse types. Lastly, we examined the prospective association between lapse type and weight loss. Eating at an unintended time was the only lapse type that predicted worse weight loss outcomes. Results support the theory that distinct lapse types exist, and that lapse types can be predicted by both momentary conditions and individual tendencies toward certain physical and affective states. However, not all lapse types may impact weight outcomes. Future research on behaviors that constitute dietary lapse is warranted and could inform personalized weight loss treatments.",2018,Eating at an unintended time was the only lapse type that predicted worse weight loss outcomes.,"['individuals with overweight/obesity', 'three lapse types-eating a larger portion than intended, eating an unintended type of food, and eating at an unplanned time-in adults (N\u202f=\u202f189; M BMI \u202f=\u202f36.93\u202f±\u202f5.83\u202fkg/m 2 ; 82.0% female; M age \u202f=\u202f51.81\u202f±\u202f9.76 years) enrolled']",[],"['lapse type and weight loss', 'Weight change', 'deprivation, hunger, and boredom increased likelihood of different lapse types']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449492', 'cui_str': 'Type of food (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0006019', 'cui_str': 'Boredoms'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",2.0,0.0159824,Eating at an unintended time was the only lapse type that predicted worse weight loss outcomes.,"[{'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA; Department of Psychology, Drexel University, Philadelphia, PA, USA; Warren Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA. Electronic address: stephanie_goldstein@brown.edu.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Dochat', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Schumacher', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA; Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Neuropsychiatric Research Institute, Fargo, ND, USA; University of North Dakota School of Medicine and Health Sciences, Department of Psychiatry and Behavioral Science, Fargo, ND, USA.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Warren Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA; Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'The Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA; Department of Psychology, Drexel University, Philadelphia, PA, USA.'}]",Appetite,['10.1016/j.appet.2018.07.003']
788,31591408,Estimation of nephron number in living humans by combining unenhanced computed tomography with biopsy-based stereology.,"Methods for estimating nephron number in a clinical setting may be useful for predicting renal outcomes. This study aimed to establish such a method using unenhanced computed tomography (CT) and biopsy-based stereology. Patients or living kidney donors simultaneously subjected to enhanced and unenhanced CT examinations were randomly assigned to development and validation groups. The enhanced CT-measured arterial phase and the venous phase images of kidneys were regarded as the true values for cortical volume and parenchymal volume, respectively. Linear multiple regression analysis was used to create models for estimating cortical volume using explanatory variables including unenhanced CT-measured parenchymal volume. Nephron number was determined as the product of cortical volume and the glomerular density in biopsies of donors. Five equations for estimating cortical volume were created and verified. In donors, estimated nephron number by unenhanced CT was consistent with that by enhanced CT, with minimal errors in all models (636-655 ± 210-219 vs. 648 ± 224 × 10 3 /kidney). Clinical characteristics combined with parenchymal volume did not improve the equation over parenchymal volume alone. These results support the feasibility of estimating nephron number by a combination of unenhanced CT and biopsy-based stereology, with a possible application for renal disease patients who are often not suitable for contrast media.",2019,"In donors, estimated nephron number by unenhanced CT was consistent with that by enhanced CT, with minimal errors in all models (636-655 ± 210-219 vs. 648 ± ","['renal disease patients who are often not suitable for contrast media', '224', 'Patients or living kidney donors simultaneously subjected to enhanced and unenhanced CT examinations']","['unenhanced computed tomography (CT) and biopsy-based stereology', 'unenhanced computed tomography with biopsy-based stereology']",[],"[{'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C4305252', 'cui_str': 'Live donor of kidney (person)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0221754,"In donors, estimated nephron number by unenhanced CT was consistent with that by enhanced CT, with minimal errors in all models (636-655 ± 210-219 vs. 648 ± ","[{'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan. tsuboi-n@jikei.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okabayashi', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Haruhara', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Kanzaki', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshiharu', 'Initials': 'T', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Epidemiology and Public Health, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimizu', 'Affiliation': 'Department of Analytic Human Pathology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Rule', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bertram', 'Affiliation': 'Department of Anatomy and Developmental Biology and Biomedical Discovery Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yokoo', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}]",Scientific reports,['10.1038/s41598-019-50529-x']
789,31601842,Pomegranate Juice and Extract Consumption Increases the Resistance to UVB-induced Erythema and Changes the Skin Microbiome in Healthy Women: a Randomized Controlled Trial.,"In vitro and animal studies have demonstrated that topical application and oral consumption of pomegranate reduces UVB-induced skin damage. We therefore investigated if oral pomegranate consumption will reduce photodamage from UVB irradiation and alter the composition of the skin microbiota in a randomized controlled, parallel, three-arm, open label study. Seventy-four female participants (30-45 years) with Fitzpatrick skin type II-IV were randomly assigned (1:1:1) to 1000 mg of pomegranate extract (PomX), 8 oz of pomegranate juice (PomJ) or placebo for 12 weeks. Minimal erythema dose (MED) and melanin index were determined using a cutometer (mexameter probe). Skin microbiota was determined using 16S rRNA sequencing. The MED was significantly increased in the PomX and PomJ group compared to placebo. There was no significant difference on phylum, but on family and genus level bacterial composition of skin samples collected at baseline and after 12 week intervention showed significant differences between PomJ, PomX and placebo. Members of the Methylobacteriaceae family contain pigments absorbing UV irradiation and might contribute to UVB skin protection. However, we were not able to establish a direct correlation between increased MED and bacterial abundance. In summary daily oral pomegranate consumption may lead to enhanced protection from UV photodamage.",2019,"There was no significant difference on phylum, but on family and genus level bacterial composition of skin samples collected at baseline and after 12 week intervention showed significant differences between PomJ, PomX and placebo.","['Seventy-four female participants (30-45 years) with Fitzpatrick skin type II-IV', 'Healthy Women']","['Pomegranate Juice and Extract Consumption', 'placebo', 'pomegranate extract (PomX), 8\u2009oz of pomegranate juice (PomJ) or placebo']","['MED', 'MED) and melanin index', 'Minimal erythema dose', 'level bacterial composition of skin samples', 'Skin microbiota']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}]","[{'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429195', 'cui_str': 'Minimal erythema dose (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0444099', 'cui_str': 'Skin (tissue) specimen (specimen)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",74.0,0.0614278,"There was no significant difference on phylum, but on family and genus level bacterial composition of skin samples collected at baseline and after 12 week intervention showed significant differences between PomJ, PomX and placebo.","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Henning', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA. shenning@mednet.ucla.edu.'}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Ru-Po', 'Initials': 'RP', 'LastName': 'Lee', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Thames', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gilbuena', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Clinical Nutrition, 2nd Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China.'}, {'ForeName': 'Yunhui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Esther HaeIn', 'Initials': 'EH', 'LastName': 'Park', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Statistics Core, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heber', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, Department of Medicine, Los Angeles, CA, 90095, USA.'}]",Scientific reports,['10.1038/s41598-019-50926-2']
790,31518224,A Pilot Study of Exenatide Actions in Alzheimer's Disease.,"BACKGROUND


Strong preclinical evidence suggests that exenatide, a glucagon-like peptide-1 (GLP- 1) receptor agonist used for treating type 2 diabetes, is neuroprotective and disease-modifying in Alzheimer's Disease (AD).
OBJECTIVE


We performed an 18-month double-blind randomized placebo-controlled Phase II clinical trial to assess the safety and tolerability of exenatide and explore treatment responses for clinical, cognitive, and biomarker outcomes in early AD.
METHOD


Eighteen participants with high probability AD based on cerebrospinal fluid (CSF) biomarkers completed the entire study prior to its early termination by the sponsor; partial outcomes were available for twentyone.
RESULTS


Exenatide was safe and well-tolerated, showing an expectedly higher incidence of nausea and decreased appetite compared to placebo and decreasing glucose and GLP-1 during Oral Glucose Tolerance Tests. Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
CONCLUSION


The positive finding of lower EV Aβ42 supports emerging evidence that plasma neuronal EVs provide an effective platform for demonstrating biomarker responses in clinical trials in AD. The study was underpowered due to early termination and therefore we cannot draw any firm conclusions. However, the analysis of secondary outcomes shows no trends in support of the hypothesis that exenatide is diseasemodifying in clinical AD, and lowering EV Aβ42 in and of itself may not improve cognitive outcomes in AD.",2019,"Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
","[""Alzheimer's disease"", 'Eighteen participants with high probability AD based on cerebrospinal fluid (CSF) biomarkers completed the entire study prior to its early termination by the sponsor; partial outcomes were available for twenty-one', 'early AD']","['placebo', 'Exenatide', 'exenatide', 'exenatide actions']","['clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV', 'nausea and decreased appetite', 'safety and tolerability', 'safe and well-tolerated']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007807'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",18.0,0.226788,"Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
","[{'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Mullins', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Mustapic', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Chee W', 'Initials': 'CW', 'LastName': 'Chia', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Carlson', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulyani', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Yazhou', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Gerontology Branch, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Mattson', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, Intramural Research Program, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Josephine M', 'Initials': 'JM', 'LastName': 'Egan', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Greig', 'Affiliation': 'Translational Gerontology Branch, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}]",Current Alzheimer research,['10.2174/1567205016666190913155950']
791,31597934,"Short-Term Effects of Kinesio Taping in the Treatment of Latent and Active Upper Trapezius Trigger Points: two Prospective, Randomized, Sham-Controlled Trials.","The presence of myofascial trigger points (MTrPs) is one of the most common causes of musculoskeletal problems and may lead to limited professional activity. Among the various treatment methods proposed for MTrPs, Kinesio Taping (KT) is a non-invasive, painless, and less time-consuming method with fewer side effects that has become widely used as a therapeutic tool in a variety of prevention and rehabilitation protocols. The aim of the study was to evaluate the immediate and short-term efficacy of the space correction KT technique in patients with latent or active MTrPs in the upper trapezius muscle. Two parallel randomized sham-controlled trials were simultaneously executed: in trial A, ninety-seven participants with latent MTrPs were randomly assigned to either the KT (n = 51) or sham (n = 46) group; in trial B, thirty-seven participants with active MTrPs were assigned to the KT (n = 20) or sham (n = 17) group. The primary outcome was pressure pain threshold (PPT) in the upper trapezius muscle, measured with algometry. Secondary outcomes included the active range of motion (ROM) of the cervical spine (lateral flexion and rotation), measured with a cervical ROM goniometer. In each trial, two-way ANOVA tests were used to compare the study effects on the outcome measures between the groups, with time serving as the intra-group factor (baseline, immediately, and 72 h after the application) and the intervention type (KT and sham) as the between-group factor. At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI: [-7.4, 5.1]), cervical lateral flexion (trial A: mean difference 0.2 degrees; 95% CI: [-2.7, 3.1], trial B: mean difference -2.4 degrees; 95% CI: [-8.4, 3.6]), and cervical rotation (trial A: mean difference 3.7 degrees; 95% CI: [-0.1, 7.5], trial B: mean difference 1.4 degrees; 95% CI: [-5.7, 8.4]), compared to the sham groups. Thus, the results of this study do not support the use of the space correction KT technique to treat patients with latent or active myofascial trigger points in the upper trapezius muscle.",2019,"At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI:","['patients with latent or active MTrPs in the upper trapezius muscle', 'ninety-seven participants with latent MTrPs']","['MTrPs, Kinesio Taping (KT', 'space correction KT technique', 'KT', 'Kinesio Taping']","['cervical lateral flexion', 'cervical rotation', 'active range of motion (ROM) of the cervical spine (lateral flexion and rotation), measured with a cervical ROM goniometer', 'pressure pain threshold (PPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion, function (observable entity)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",97.0,0.28557,"At 72 h, participants receiving KT did not show significant differences in PPT (trial A: mean difference -1.8 N; 95% CI: [-8.1, 4.4], trial B: mean difference -1.2 N; 95% CI:","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Noguera-Iturbe', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Gramage', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Montañez-Aguilera', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. juanfran@uchceu.es.'}]",Scientific reports,['10.1038/s41598-019-51146-4']
792,31537697,Sequential screening for lung cancer in a high-risk group: randomised controlled trial: LungSEARCH: a randomised controlled trial of Surveillance using sputum and imaging for the EARly detection of lung Cancer in a High-risk group.,"BACKGROUND


Low-dose computed tomography (LDCT) screening detects early-stage lung cancer and reduces mortality. We proposed a sequential approach targeted to a high-risk group as a potentially efficient screening strategy.
METHODS


LungSEARCH was a national multicentre randomised trial. Current/ex-smokers with mild/moderate chronic obstructive pulmonary disease (COPD) were allocated (1:1) to have 5 years surveillance or not. Screened participants provided annual sputum samples for cytology and cytometry, and if abnormal were offered annual LDCT and autofluorescence bronchoscopy (AFB). Those with normal sputum provided annual samples. The primary end-point was the percentage of lung cancers diagnosed at stage I/II (nonsmall cell) or limited disease (small cell).
RESULTS


1568 participants were randomised during 2007-2011 from 10 UK centres. 85.2% of those screened provided an adequate baseline sputum sample. There were 42 lung cancers among 785 screened individuals and 36 lung cancers among 783 controls. 54.8% (23 out of 42) of screened individuals  versus  45.2% (14 out of 31) of controls with known staging were diagnosed with early-stage disease (one-sided p=0.24). Relative risk was 1.21 (95% CI 0.75-1.95) or 0.82 (95% CI 0.52-1.31) for early-stage or advanced cancers, respectively. Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) with a cumulative false-positive rate (FPR) of 32.8%. 55% of cancers had normal sputum results throughout. Among sputum-positive individuals who had AFB, sensitivity was 45.5% and cumulative FPR was 39.5%; the corresponding measures for those who had LDCT were 100% and 16.1%, respectively.
CONCLUSIONS


Our sequential strategy, using sputum cytology/cytometry to select high-risk individuals for AFB and LDCT, did not lead to a clear stage shift and did not improve the efficiency of lung cancer screening.",2019,Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) and cumulative false-positive rate (FPR) 32.8%.,"['Current/former smokers with mild/moderate COPD', '1568 individuals were randomised 2007-2011, from 10 UK centres', '42 lung cancers among 785 screened and 36 among 783 controls']","['Sequential screening', 'Low-dose CT (LDCT) screening']","['percentage of lung cancers diagnosed at stage I/II (non-small cell) or limited disease (small cell', 'Overall sensitivity for sputum', 'cumulative false-positive rate']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",1568.0,0.472867,Overall sensitivity for sputum (in those randomised to surveillance) was low (40.5%) and cumulative false-positive rate (FPR) 32.8%.,"[{'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Spiro', 'Affiliation': 'Dept of Respiratory Medicine, University College Hospital, London, UK.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Dept of Respiratory Medicine, Royal Brompton Hospital, Chelsea and Westminster Hospital and Imperial College London, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Dept of Oncology, Royal Papworth Hospital and University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'UCL Respiratory, Dept of Medicine, University College London, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Janes', 'Affiliation': 'UCL Respiratory, Dept of Medicine, University College London, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Callister', 'Affiliation': 'Dept of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Novelli', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Shaw', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Gabrijela', 'Initials': 'G', 'LastName': 'Kocjan', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Griffiths', 'Affiliation': 'Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Cellular Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Lung Cancer and Thoracic Surgery Directorate, Manchester University NHS Trust and University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Magee', 'Affiliation': 'Respiratory Medicine, Belfast City Hospital, Belfast, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Peake', 'Affiliation': 'Dept of Immunity, Infection and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dhillon', 'Affiliation': 'Respiratory Medicine, University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Sridharan', 'Affiliation': 'Dept of Thoracic Medicine, Sunderland Royal Hospital, Sunderland, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Nicholson', 'Affiliation': 'Dept of Histopathology, Royal Brompton Hospital and Harefield NHS Foundation Trust and National Heart and Lung Institute, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Padley', 'Affiliation': 'Radiology, Royal Brompton Hospital and National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Radiology (Imaging), University College Hospital, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Nyasha', 'Initials': 'N', 'LastName': 'Chinyanganya', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ashford-Turner', 'Affiliation': 'Cardio-Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Research and Development, Royal Papworth Hospital, Cambridge, UK.'}, {'ForeName': 'Dahmane', 'Initials': 'D', 'LastName': 'Oukrif', 'Affiliation': 'Dept of Pathology, University College Hospital, London, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rabbitts', 'Affiliation': 'Leeds Institute of Cancer and Pathology (LICAP), University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK and UCL Cancer Trials Centre, London, UK.'}]",The European respiratory journal,['10.1183/13993003.00581-2019']
793,31416746,Oxytocin increases eye gaze in schizophrenia.,"Abnormal eye gaze is common in schizophrenia and linked to functional impairment. The hypothalamic neuropeptide oxytocin modulates visual attention to social stimuli, but its effects on eye gaze in schizophrenia are unknown. We examined visual scanning of faces in men with schizophrenia and neurotypical controls to quantify oxytocin effects on eye gaze. In a randomized, double-blind, crossover study, 33 men with schizophrenia and 39 matched controls received one dose of intranasal oxytocin (40 IU) and placebo on separate testing days. Participants viewed 20 color photographs of faces while their gaze patterns were recorded. We tested for differences in fixation time on the eyes between patients and controls as well as oxytocin effects using linear mixed-effects models. We also tested whether attachment style, symptom severity, and anti-dopaminergic medication dosage moderated oxytocin effects. In the placebo condition, patients showed reduced fixation time on the eyes compared to controls. Oxytocin was associated with an increase in fixation time among patients, but a decrease among controls. Higher attachment anxiety and greater symptom severity predicted increased fixation time on the eyes on oxytocin versus placebo. Anti-dopaminergic medication dosage and attachment avoidance did not impact response to oxytocin. Consistent with findings that oxytocin optimizes processing of social stimuli, intranasal oxytocin enhanced eye gaze in men with schizophrenia. Further work is needed to determine whether changes in eye gaze impact social cognition and functional outcomes. Both attachment anxiety and symptom severity predicted oxytocin response, highlighting the importance of examining potential moderators of oxytocin effects in future studies.",2019,Higher attachment anxiety and greater symptom severity predicted increased fixation time on the eyes on oxytocin versus placebo.,"['men with schizophrenia', 'men with schizophrenia and neurotypical controls', '33 men with schizophrenia and 39 matched controls']","['Oxytocin', 'oxytocin', 'placebo', 'intranasal oxytocin', 'hypothalamic neuropeptide oxytocin']","['reduced fixation time', 'fixation time', 'eye gaze', 'Higher attachment anxiety']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",20.0,0.156152,Higher attachment anxiety and greater symptom severity predicted increased fixation time on the eyes on oxytocin versus placebo.,"[{'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Bradley', 'Affiliation': ""University of California, San Francisco, CA, United States of America; San Francisco Veteran's Affairs Medical Center, San Francisco, CA, United States of America. Electronic address: ellen.bradley@ucsf.edu.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Seitz', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Niles', 'Affiliation': ""University of California, San Francisco, CA, United States of America; San Francisco Veteran's Affairs Medical Center, San Francisco, CA, United States of America.""}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Rankin', 'Affiliation': 'University of California, San Francisco, CA, United States of America.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': ""University of California, San Francisco, CA, United States of America; San Francisco Veteran's Affairs Medical Center, San Francisco, CA, United States of America.""}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': ""University of California, San Francisco, CA, United States of America; San Francisco Veteran's Affairs Medical Center, San Francisco, CA, United States of America.""}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': ""University of California, San Francisco, CA, United States of America; San Francisco Veteran's Affairs Medical Center, San Francisco, CA, United States of America.""}]",Schizophrenia research,['10.1016/j.schres.2019.07.039']
794,29891538,Antitumor Activity Associated with Prolonged Persistence of Adoptively Transferred NY-ESO-1  c259 T Cells in Synovial Sarcoma.,"We evaluated the safety and activity of autologous T cells expressing NY-ESO-1 c259 , an affinity-enhanced T-cell receptor (TCR) recognizing an HLA-A2-restricted NY-ESO-1/LAGE1a-derived peptide, in patients with metastatic synovial sarcoma (NY-ESO-1 c259 T cells). Confirmed antitumor responses occurred in 50% of patients (6/12) and were characterized by tumor shrinkage over several months. Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders. Most of the infused NY-ESO-1 c259 T cells exhibited an effector memory phenotype following  ex vivo  expansion, but the persisting pools comprised largely central memory and stem-cell memory subsets, which remained polyfunctional and showed no evidence of T-cell exhaustion despite persistent tumor burdens. Next-generation sequencing of endogenous TCRs in CD8 +  NY-ESO-1 c259 T cells revealed clonal diversity without contraction over time. These data suggest that regenerative pools of NY-ESO-1 c259 T cells produced a continuing supply of effector cells to mediate sustained, clinically meaningful antitumor effects. Significance:  Metastatic synovial sarcoma is incurable with standard therapy. We employed engineered T cells targeting NY-ESO-1, and the data suggest that robust, self-regenerating pools of CD8 +  NY-ESO-1 c259 T cells produce a continuing supply of effector cells over several months that mediate clinically meaningful antitumor effects despite prolonged exposure to antigen.  Cancer Discov; 8(8); 944-57. ©2018 AACR. See related commentary by Keung and Tawbi, p. 914 This article is highlighted in the In This Issue feature, p. 899 .",2018,Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders.,"['Cancer Discov; 8(8); 944-57', 'Synovial Sarcoma', 'patients with metastatic synovial sarcoma (NY-ESO-1 c259 T cells']",[],"['Circulating NY-ESO-1 c259 T cells', 'antitumor responses', 'Antitumor Activity']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039101', 'cui_str': 'Synovioma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]",[],"[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",914.0,0.0417299,Circulating NY-ESO-1 c259 T cells were present postinfusion in all patients and persisted for at least 6 months in all responders.,"[{'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': ""D'Angelo"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York. E-mail:dangelos@mskcc.org.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Melchiori', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Merchant', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glod', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Rosandra', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Grupp', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chagin', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gwendolyn K', 'Initials': 'GK', 'LastName': 'Binder', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Samik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Lowther', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Ruoxi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bath', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Tipping', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Betts', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Ramachandran', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Navenot', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Wells', 'Affiliation': 'Parker Institute for Cancer Immunotherapy, San Francisco, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Winkle', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Kari', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Trupti', 'Initials': 'T', 'LastName': 'Trivedi', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Holdich', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Lini', 'Initials': 'L', 'LastName': 'Pandite', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Amado', 'Affiliation': 'Adaptimmune, Oxford, United Kingdom, and Philadelphia, Pennsylvania.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Mackall', 'Affiliation': 'Pediatric Oncology Branch, NCI, Bethesda, Maryland.'}]",Cancer discovery,['10.1158/2159-8290.CD-17-1417']
795,29681047,"The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial.","PURPOSE


Insufficient alleviation of pain after percutaneous nephrolithotomy causes patient dissatisfaction and generates additional morbidity factors by preventing early mobilization. This study investigated the effects of bupivacaine infiltration with two different doses around the nephrostomy tract after percutaneous nephrolithotomy.
MATERIALS AND METHODS


Patients who underwent subcostal single entrance percutaneous nephrolithotomy were randomly divided into 3 groups of 20 patients. While the first and second group were planned to receive bupivacaine at rates of 0.5% and 0.25% respectively, the third group was planned to receive a placebo agent to preserve the doubly blinded nature of the study.
RESULTS


A statistically significant difference was found in the number of patients using tramadole. The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups. Although there was no difference between the groups in terms of total amount of analgesic usage, patients who received higher concentrations of bupivacaine were likely to requirea lower amount of narcotic agent. The frequency of analgesic administration decreased significantly in patients of both groups that received bupivacaine. Moreover, by administering bupivacaine at a 0.5% rate, fewer patients (50%) required narcotic analgesia and the first time of analgesic administration was found to be significantly later.
CONCLUSION


Administering bupivacaine at a 0.5% rate around the nephrostomy tract after surgery was demonstrated to be more effective.",2018,"The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups.",['Patients who underwent subcostal single entrance percutaneous nephrolithotomy were randomly divided into 3 groups of 20 patients'],"['Local Anesthetic Agent Infiltration Around Nephrostomy Tract', 'placebo', 'bupivacaine', 'Percutaneous Nephrolithotomy', 'percutaneous nephrolithotomy']","['frequency of analgesic administration', 'Postoperative Pain Control', 'narcotic analgesia and the first time of analgesic administration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0278314', 'cui_str': 'Nephrostomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0594253,"The frequency of analgesic administration was found lower in the two groups that received bupivacaine in comparison to the group that did not, while the time of the first analgesic administration in the group that received high dose bupivacaine was significantly later than the other groups.","[{'ForeName': 'Gokce', 'Initials': 'G', 'LastName': 'Dundar', 'Affiliation': 'Urology Department, Cizre State Hospital, Şırnak, Turkey. dr@gokcedundar.com.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Gokcen', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Gokce', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Emin Yener', 'Initials': 'EY', 'LastName': 'Gultekin', 'Affiliation': 'Department of Urology, Faculty of Medicine, Cumhuriyet University, Sivas, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4145']
796,28408711,A Randomized Controlled Trial to Determine the Appropriate Time to Initiate Peritoneal Dialysis after Insertion of Catheter (Timely PD Study).,"BACKGROUND


The optimal time for the commencement of peritoneal dialysis (PD) after PD catheter insertion is unclear. If dialysis is started too soon after insertion, dialysate leaks and infection could occur. However, by starting PD earlier, morbidity and costs can be reduced through lesser hemodialysis requirements. This is the first randomized controlled trial to determine the safest and shortest interval to commence PD after catheter insertion.
METHODS


All consecutive patients undergoing PD catheter insertion at the Royal Brisbane and Women's Hospital and Rockhampton Hospital from 1 March 2008 to 31 May 2013 who met the inclusion and exclusion criteria were invited to participate in the trial. Participants were randomized to 1 of 3 groups. Group 1 (G1) commenced PD at 1 week, group 2 (G2) at 2 weeks and group 3 (G3) at 4 weeks after PD catheter insertion. These groups were stratified by hospital and the presence of diabetes. Primary outcomes were the incidence of peritoneal fluid leaks or PD-related infection during the 4 weeks after commencement of PD.
RESULTS


In total 122 participants were recruited, 39, 42, and 41 randomized to G1, G2, and G3, respectively. The primary outcome catheter leak was significantly higher in G1 (28.2%) compared with G3 (2.4%,  p  = 0.001) but not compared with G2 (9.5%,  p  = 0.044), based on intention to treat analysis. These differences were even more marked when analyzed with per protocol method: G1 had a significantly higher percentage (32.4 %) compared with G3 (3.3%,  p  = 0.003) but not compared with G2 (10.5%,  p  = 0.040). Event percentages of leak were statistically higher in G1 and occurred significantly earlier compared with other groups ( p  = 0.002). Amongst diabetics, technique failure was significantly higher (28.6%) in G3 compared with 0% in G1 and 7.1% in G2 ( p  = 0.036) and earlier in G3 at 163.2 days vs 176.8 and 175.8 ( p  = 0.037) for G1 and G2, respectively.
CONCLUSION


Leaks were higher in participants commencing PD at 1 week after catheter insertion compared with the other 2 groups, and technique failure was higher in diabetics starting PD at 4 weeks.",2017,"Leaks were higher in participants commencing PD at 1 week after catheter insertion compared with the other 2 groups, and technique failure was higher in diabetics starting PD at 4 weeks.","['In total 122 participants were recruited, 39, 42, and 41 randomized to G1, G2, and G3, respectively', ""All consecutive patients undergoing PD catheter insertion at the Royal Brisbane and Women's Hospital and Rockhampton Hospital from 1 March 2008 to 31 May 2013 who met the inclusion and exclusion criteria were invited to participate in the trial""]",[],"['incidence of peritoneal fluid leaks or PD-related infection', 'Leaks', 'morbidity and costs', 'catheter leak', 'technique failure']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003964', 'cui_str': 'Peritoneal Fluid'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",122.0,0.224881,"Leaks were higher in participants commencing PD at 1 week after catheter insertion compared with the other 2 groups, and technique failure was higher in diabetics starting PD at 4 weeks.","[{'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia Dwarakanathan.Ranganathan@health.qld.gov.au.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'John', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Yeoh', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': ""O'Loughlin"", 'Affiliation': ""Department of Surgery, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Thin', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Renal Medicine, Rockhampton Base Hospital, Queensland, Australia.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Jeyaseelan', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, India.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, India.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Healy', 'Affiliation': ""Department of Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}]",Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.3747/pdi.2016.00066']
797,31872152,Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.,"Background


Globally, 1.8 million children<15 years are living with HIV. Sub-Saharan Africa (SSA), as a region, is heavily burdened by HIV, with 90% of new infections among children happening there. Within SSA, Uganda has an HIV prevalence of 7.2% among 15-49-year-olds, with high prevalence in Masaka region (12%). Uganda also reports unprecedented numbers of perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA). However adherence to antiretroviral therapy (ART) among children and youth is poor, and has been attributed to economic insecurity, including lack of finances for transportation to clinic appointments, inadequate meals to support medication consumption, and resource prioritization towards school expenses. Yet, few programs aimed at addressing ART adherence have applied combination interventions to address economic stability and ART Adherence within the traditional framework of health education and HIV care. This paper describes a study protocol for a 5-year,  Eunice Kennedy Shriver National Institute of Child Health and Human Development  (NICHD) funded, cluster randomized-controlled trial to evaluate a combination intervention, titled Suubi + Adherence, aimed at improving ART adherence among HIV perinatally infected adolescents (ages 10-16 at study enrollment) in Uganda.
Methods


Suubi + Adherence was evaluated via a two-arm cluster randomized-controlled trial design in 39 health clinics, with a total enrollment of 702 HIV + adolescents (ages 10-16 at enrollment). The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family functioning, sexual risk-taking behavior, and financial savings behavior. For potential scale-up, cost effectiveness analysis was employed to compare the relative costs and outcomes associated with each study arm: family economic strengthening comprising matched savings accounts, financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC) comprising enhanced adherence sessions to ensure more standardized and sufficient adherence counseling.
Discussion


This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA. To our knowledge, the proposed study is the first to integrate and test family economic empowerment and stability-focused interventions for HIV + adolescents in Uganda (and much of SSA)-so families would have the necessary finances to manage HIV/AIDS as a chronic illness. The study would provide crucial evidence about the effects of an economic empowerment program on short and long-term impact, which is essential if such interventions are to be taken to scale.
Trial registration


This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.",2019,This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA.,"['39 health clinics, with a total enrollment of 702 HIV\xa0+\xa0adolescents (ages 10-16\xa0at enrollment', 'HIV perinatally infected adolescents (ages 10-16\xa0at study enrollment) in Uganda', 'a 5-year,  Eunice Kennedy Shriver National Institute of Child Health and Human Development  (NICHD', 'perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA', 'perinatally infected adolescents']","['economic empowerment program', 'combination intervention, titled Suubi\xa0+\xa0Adherence', 'family economic empowerment intervention addressing HIV treatment adherence', 'financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC', 'antiretroviral therapy (ART']","['family functioning, sexual risk-taking behavior, and financial savings behavior', 'adherence to HIV treatment regimen and 2) HIV knowledge and attitudes']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0220830', 'cui_str': 'financial management'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",702.0,0.0954943,This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA.,"[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, Brown School, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'University of California San Francisco, United States.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Mellins', 'Affiliation': 'Columbia University Medical Center, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Mukasa', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Fredrick Edward', 'Initials': 'FE', 'LastName': 'Makumbi', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Rakai, Uganda.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100463']
798,30786186,Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.,"BACKGROUND


Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.
METHODS


In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding.
RESULTS


Of 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49).
CONCLUSIONS


In high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials.gov number, NCT02555878.).",2019,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","['high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism', 'High-Risk Ambulatory Patients with Cancer', '1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization', 'high-risk ambulatory patients with cancer', 'Ambulatory patients receiving']","['rivaroxaban', 'systemic cancer therapy', 'placebo', 'Rivaroxaban']","['Major bleeding', 'major bleeding', 'composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism', 'venous thromboembolism or death']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}]",1080.0,0.530441,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","[{'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Kakkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wun', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Streiff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Liebman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Patel', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Habte A', 'Initials': 'HA', 'LastName': 'Yimer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burton', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBane', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Kuderer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Lyman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1814630']
799,29615935,Transcranial Magnetic Stimulation of Medial Prefrontal and Cingulate Cortices Reduces Cocaine Self-Administration: A Pilot Study.,"Background


Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex may serve as a potential treatment for cocaine use disorder (CUD), which remains a public health problem that is refractory to treatment. The goal of this pilot study was to investigate the effect of rTMS on cocaine self-administration in the laboratory. In the self-administration sessions, CUD participants chose between cocaine and an alternative reinforcer (money) in order to directly measure cocaine-seeking behavior. The rTMS was delivered with the H7 coil, which provides stimulation to the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC). These brain regions were targeted based on previous imaging studies demonstrating alterations in their activation and connectivity in CUD.
Methods


Volunteers with CUD were admitted to an inpatient unit for the entire study and assigned to one of three rTMS groups: high frequency (10 Hz), low frequency (1 Hz), and sham. Six participants were included in each group and the rTMS was delivered on weekdays for 3 weeks. The cocaine self-administration sessions were performed at three time points: at baseline (pre-TMS, session 1), after 4 days of rTMS (session 2), and after 13 days of rTMS (session 3). During each self-administration session, the outcome measure was the number of choices for cocaine.
Results


The results showed a significant group by time effect ( p  = 0.02), where the choices for cocaine decreased between sessions 2 and 3 in the high frequency group. There was no effect of rTMS on cocaine self-administration in the low frequency or sham groups.
Conclusion


Taken in the context of the existing literature, these results contribute to the data showing that high frequency rTMS to the prefrontal cortex may serve as a potential treatment for CUD.",2018,"The results showed a significant group by time effect ( p  = 0.02), where the choices for cocaine decreased between sessions 2 and 3 in the high frequency group.","['Methods\n\n\nVolunteers with CUD were admitted to an inpatient unit for the entire study and assigned to one of three rTMS groups: high frequency (10\u2009Hz), low frequency (1\u2009Hz), and sham']","['cocaine', 'rTMS', 'Transcranial Magnetic Stimulation of Medial Prefrontal and Cingulate Cortices Reduces Cocaine Self-Administration', 'repetitive transcranial magnetic stimulation (rTMS']","['choices for cocaine', 'number of choices for cocaine', 'time effect']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",6.0,0.0160821,"The results showed a significant group by time effect ( p  = 0.02), where the choices for cocaine decreased between sessions 2 and 3 in the high frequency group.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Urban', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Grassetti', 'Affiliation': 'Research Foundation for Mental Hygeine, New York, NY, United States.'}, {'ForeName': 'Dinissa', 'Initials': 'D', 'LastName': 'Chang', 'Affiliation': 'Research Foundation for Mental Hygeine, New York, NY, United States.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Foltin', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University College of Physicians and Surgeons, The New York State Psychiatric Institute, New York, NY, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2018.00080']
800,29571271,Subgroup effects of occupational therapy-based intervention for people with advanced cancer.,"Background:  Many people with advanced cancer have decreased ability to perform activities of daily living (ADL). We recently performed a randomized, controlled trial (RCT) assessing the efficacy of an occupational therapy-based program, the 'Cancer Home-Life Intervention' in people with advanced cancer ( N  = 242) and found no overall effects on ADL ability. However, heterogeneity of treatment effect may disguise subgroup differences. Objective:  To investigate whether subgroups of people with advanced cancer gain positive effects from the 'Cancer Home-Life Intervention' on ADL ability. Material and method:  An exploratory subgroup analysis including 191 participants from a RCT. The outcome was  ADL motor ability  measured by the Assessment of Motor and Process Skills (AMPS). Subgroups were defined by age, gender, years of education, type of primary tumor, functional level, and activity problems. Results:  The 'Cancer Home-Life Intervention' had no statistically significant effect in the six subgroups. Modifying effects of age (0.30 [95% CI: -0.05 to 0.64]) and gender (0.23 [95% CI: -0.11 to 0.57]) were not found. Conclusion:  There were no subgroup effects of the 'Cancer Home-Life Intervention'on ADL motor ability. Some indications suggest greater effects for those aged below 69 years; however, this result should be interpreted with caution.",2020,The 'Cancer Home-Life Intervention' had no statistically significant effect in the six subgroups.,"['people with advanced cancer', ""subgroups of people with advanced cancer gain positive effects from the 'Cancer Home-Life Intervention' on ADL ability"", 'people with advanced cancer (N\u2009=\u2009242', '191 participants from a RCT']","['occupational therapy-based intervention', ""occupational therapy-based program, the 'Cancer Home-Life Intervention""]",['ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS'],"[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451005', 'cui_str': 'Assessment of motor and process skills (assessment scale)'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]",,0.136519,The 'Cancer Home-Life Intervention' had no statistically significant effect in the six subgroups.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sampedro Pilegaard', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense C, Denmark.'}, {'ForeName': 'Lisa Gregersen', 'Initials': 'LG', 'LastName': 'Oestergaard', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'la Cour', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense C, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Thit Johnsen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Brandt', 'Affiliation': 'Odense Patient Data Explorative Network, Odense University Hospital, University of Southern Denmark, Odense C, Denmark.'}]",Scandinavian journal of occupational therapy,['10.1080/11038128.2018.1455897']
801,30982849,Heparin dosing in uninterrupted anticoagulation with dabigatran vs. warfarin in atrial fibrillation ablation: RE-CIRCUIT study.,"AIMS


To describe heparin dosing requirements in patients who underwent catheter ablation of atrial fibrillation with uninterrupted anticoagulation using dabigatran etexilate (dabigatran) or warfarin to attain therapeutic activated clotting time (ACT) in the RE-CIRCUIT® study. The RE-CIRCUIT study showed significantly fewer major bleeding events in the dabigatran vs. warfarin treatment group. Unfractionated heparin was administered during the procedure to maintain ACT >300 s.
METHODS AND RESULTS


Patients were randomly assigned to dabigatran 150 mg bid or international normalized ratio-adjusted warfarin. Ablation was performed with uninterrupted anticoagulation and continued for 8 weeks after the procedure. Heparin was administered after placement of femoral sheaths before or immediately after transseptal puncture. Ablation was performed in 635 patients (dabigatran, 317; warfarin, 318); data were available from 396 patients administered heparin (dabigatran, 191; warfarin, 205). Most frequent time window from last dose of study drug to septal puncture was 0 to <4 h in the dabigatran (41.3%) and 16 to <24 h in the warfarin arms (44.7%). Overall mean (standard deviation) heparin dose was similar between the dabigatran and warfarin groups [12 402 (10 721) vs. 11 910 (8359) IU, respectively]. Heparin dosing requirement to reach therapeutic ACT was lowest when time from last dose of dabigatran to septal puncture was 0 to <4 h.
CONCLUSION


Patients treated with dabigatran required a similar amount of unfractionated heparin as those treated with warfarin to achieve an ACT of >300 s during ablation. More heparin units were required when the time from the last dose of dabigatran to septal puncture increased.",2019,The RE-CIRCUIT study showed significantly fewer major bleeding events in the dabigatran vs. warfarin treatment group.,"['atrial fibrillation ablation', 'patients who underwent catheter ablation of atrial fibrillation with uninterrupted anticoagulation using', '635 patients (dabigatran, 317; warfarin, 318); data were available from 396 patients administered']","['dabigatran etexilate (dabigatran) or warfarin', 'Heparin', 'heparin', 'unfractionated heparin', 'heparin (dabigatran, 191; warfarin', 'warfarin', 'dabigatran 150\u2009mg bid or international normalized ratio-adjusted warfarin', 'dabigatran vs. warfarin', 'Unfractionated heparin']","['major bleeding events', 'Overall mean (standard deviation) heparin dose']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",635.0,0.0619785,The RE-CIRCUIT study showed significantly fewer major bleeding events in the dabigatran vs. warfarin treatment group.,"[{'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schilling', 'Affiliation': ""St Bartholomew's Hospital, London, UK.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'J.W. Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okumura', 'Affiliation': 'Saiseikai Kumamoto Hospital, Cardiovascular Center, Kumamoto, Japan.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim Pharma, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim Pharma, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Branislav', 'Initials': 'B', 'LastName': 'Bis', 'Affiliation': 'Boehringer Ingelheim RCV, Vienna, Austria.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Gerstenfeld', 'Affiliation': 'University of California, San Francisco, CA, USA.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz057']
802,3346287,Fixation of displaced subcapital femoral fractures. Compression screw fixation versus double divergent pins.,"One hundred and twenty-seven consecutive patients with displaced subcapital fractures of the femoral neck (Garden Grade III or IV) all under 80 years of age and independently mobile, were randomly allocated to fixation with either double divergent pins or a single sliding screw-plate device. The incidence of non-union and infection in the sliding screw-plate group was significantly higher, and we believe that when internal fixation is considered appropriate multiple pinning should be used. Mobility after treatment was disappointing in about half of the patients, and we feel that internal fixation can only be justified in patients who are physiologically well preserved and who maintain a high level of activity.",1988,"The incidence of non-union and infection in the sliding screw-plate group was significantly higher, and we believe that when internal fixation is considered appropriate multiple pinning should be used.","['displaced subcapital femoral fractures', 'One hundred and twenty-seven consecutive patients with displaced subcapital fractures of the femoral neck (Garden Grade III or IV) all under 80 years of age and independently mobile']","['fixation with either double divergent pins or a single sliding screw-plate device', 'Compression screw fixation versus double divergent pins']","['Mobility', 'incidence of non-union and infection']","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0441824', 'cui_str': 'Garden grade III (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",127.0,0.0250672,"The incidence of non-union and infection in the sliding screw-plate group was significantly higher, and we believe that when internal fixation is considered appropriate multiple pinning should be used.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Christie', 'Affiliation': 'Royal Infirmary, Edinburgh, Scotland.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Howie', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Armour', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
803,32051972,Plaque Inhibitory Effect of Hyaluronan-Containing Mouthwash in a 4-Day Non-Brushing Model.,"PURPOSE


Despite being the gold standard antiplaque agent, chlorhexidine (CHX) has many adverse effects that make scientists search for new agents to combat biofilms as effective as CHX. Hyaluronan, also known as hyaluronic acid (HA), is a natural polysaccharide with anti-inflammatory, antioxidant and bacteriostatic properties. The objectives were to evaluate the plaque inhibitory, and anti-inflammatory effects of HA mouthwash compared to CHX and distilled water (DW) in a 4-day non-brushing model together with the participants' preference to the used products.
MATERIALS AND METHODS


Thirty-three systemically and periodontally healthy subjects were included in this randomised, double-blinded, crossover clinical study. Subjects were randomly assigned into three treatment-sequence groups to use three mouthwashes one after another, in three different time periods. After professional prophylaxis at day 1, subjects refrained from all oral hygiene measures and used mouthwashes that were individually allocated to them. On day 5, scoring of plaque index (PI) according to Turetsky modification of Quigley Hein Index system, modified gingival index (MGI) and measurement of gingival crevice fluid (GCF) volume were performed. Treatment satisfaction questionnaire form was given at the end of each experimental period.
RESULTS


CHX showed statistically significant reduction in PI followed by HA (p = 0.048). No statistically significant differences were detected between HA and CHX in terms of MGI and GCF volume. For HA, subjects reported significantly better taste, less sensitivity, burning sensation, mouth dryness and numbness perception compared to CHX and DW.
CONCLUSIONS


CHX revealed the best plaque inhibition closely followed by HA. Early gingival inflammatory changes were found similar for CHX and HA. Furthermore, HA was well accepted with better perceptions than CHX and DW.",2020,"For HA, subjects reported significantly better taste, less sensitivity, burning sensation, mouth dryness and numbness perception compared to CHX and DW.
",['Thirty-three systemically and periodontally healthy subjects'],"['CHX and distilled water (DW', 'chlorhexidine (CHX', 'Hyaluronan-Containing Mouthwash']","['MGI and GCF volume', 'Early gingival inflammatory changes', 'plaque index (PI) according to Turetsky modification of Quigley Hein Index system, modified gingival index (MGI) and measurement of gingival crevice fluid (GCF) volume', 'sensitivity, burning sensation, mouth dryness and numbness perception']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0447436', 'cui_str': 'Subgingival space'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",33.0,0.0322583,"For HA, subjects reported significantly better taste, less sensitivity, burning sensation, mouth dryness and numbness perception compared to CHX and DW.
","[{'ForeName': 'Begüm', 'Initials': 'B', 'LastName': 'Gizligoz', 'Affiliation': ''}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Ince Kuka', 'Affiliation': ''}, {'ForeName': 'Ogul Leman', 'Initials': 'OL', 'LastName': 'Tunar', 'Affiliation': ''}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ozkan Karaca', 'Affiliation': ''}, {'ForeName': 'Hare', 'Initials': 'H', 'LastName': 'Gursoy', 'Affiliation': ''}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Kuru', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43936']
804,29299888,Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision.,"PURPOSE


Penile nerve block is the most popular nerve block for the circumcision in pediatric patients. This study aimed to compare the analgesic efficiency of penile nerve block and the pudendal nerve block on postoperative pain and additional analgesic requirements in children undergoing circumcision.
MATERIAL AND METHODS


This prospective randomized double-blind study enrolled 85 children, aged 1 to10 years, undergoing circumcision. The patients were randomly divided into two groups either receiving dorsal penile block group (PNB-Group) or pudendal nerve block (PDB-Group). In the PNB-Group, 0.3 ml/kg 0.25 % bupivacaine was used; and, in the PDB-Group, 0.3 ml/kg bupivacaine was applied with nerve stimulator at a concentration of 0.25%. In the postoperative period, the modified CHEOPS pain scale scoring and additional analgesic demand were evaluated at the 5th and 30th minutes and at the 1st and 2nd hours. The subsequent pain evaluations were made by the parents at home, at the postoperative 6th, 12th, 18th and 24th hours.
RESULTS


Seven patients were excluded from the study, and seventy eight patients were evaluated for analysis. Patients in PDB-Group had significantly lower postoperative pain intensity and lower mCHEOPS scores (3.83 ± 0.98) when compared to the PNB-Group (6.47 ± 0.91) (P < .01) at all measurement times and none of patients in PDB-Group had additional analgesic requirements up to 24 hours. Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours. 3.8%, 30.8%, 46.2% and 59% of the patients in the PNB group needed additional analgesia respectively at 5th, 6th, 12th and 18th hours.
CONCLUSION


Pudendal nerve block provided additional analgesic free period and had better analgesic efficiency compared to the penile nerve block lasting until 24 hours after operation.",2018,"Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours.","['children undergoing circumcision', 'Children Undergoing Circumcision', 'pediatric patients', 'enrolled 85 children, aged 1 to10 years, undergoing circumcision', 'Seven patients were excluded from the study, and seventy eight patients were evaluated for analysis']","['penile nerve block and the pudendal nerve block', 'bupivacaine', 'dorsal penile block group (PNB-Group) or pudendal nerve block (PDB-Group', 'Pudendal Nerve Block Versus Penile Nerve Block']","['modified CHEOPS pain scale scoring and additional analgesic demand', 'additional analgesic requirements', 'subsequent pain evaluations', 'postoperative pain intensity and lower mCHEOPS scores', 'analgesic efficiency', 'additional analgesia', 'postoperative pain and additional analgesic requirements', 'analgesic requirements']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0228959', 'cui_str': 'Pudendal Nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0394769', 'cui_str': 'Local anesthetic penile block (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",85.0,0.056487,"Patients in the PNB-Group had significantly more analgesic requirements at all measurements times except at the 1st, 2nd, 24th hours.","[{'ForeName': 'Ayse Cigdem', 'Initials': 'AC', 'LastName': 'Tutuncu', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY. actutuncu@gmail.com.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kendigelen', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Gulruh', 'Initials': 'G', 'LastName': 'Ashyyeralyeva', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Fatis', 'Initials': 'F', 'LastName': 'Altintas', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}, {'ForeName': 'Senol', 'Initials': 'S', 'LastName': 'Emre', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Pediatric Surgery, Istanbul TURKEY.'}, {'ForeName': 'Rahsan', 'Initials': 'R', 'LastName': 'Ozcan', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Pediatric Surgery, Istanbul TURKEY.'}, {'ForeName': 'Guner', 'Initials': 'G', 'LastName': 'Kaya', 'Affiliation': 'Cerrahpasa Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, TURKEY.'}]",Urology journal,['10.22037/uj.v0i0.4292']
805,29308579,Improvement of Erection Related Incision Pain in Circumcision Patients using Interrupted Rapid Eye Movement Sleep: A Randomized Controlled Study.,"INTRODUCTION


Postoperative pain from male circumcision (MC) is common especially in the sleep-related erection period. This study aims to explore the effect of interrupted rapid eye movement (IREM) sleep on relieving SRE-related incision pain and the improvement of other clinical outcomes.
MATERIALS AND METHODS


This simple randomized controlled study was conducted between May and November 2016. Approval was obtained from the local ethical committee on 5 May 2016. Ninety participants who underwent male circumcision were divided into the interrupted rapid eye movement sleep group and the control group. The times and the cumulative time of erection-related moderate and severe pain in minutes at night for 3 days after the operation were observed and compared. We also compared the condition of the incision swelling and healing.Sleep time at night was used to evaluate the safety of interrupted rapid eye movement sleep.
RESULTS


For the first 3 days after the operation, the times of sleep-related erection pain were significantly decreased in the IREM sleep group (P = .010). Five patients reported that there was no pain during night. The cumulative time of erection-related moderate and severe pain was statistically decreased in the interrupted rapid eye movement sleep group (P = .034). After 3 days, there was no moderate and severe pain related to sleep-related erection in the 2 groups. There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
CONCLUSION


Interrupted rapid eye movement sleep is an effective, simple, and free treatment to relieve incision pain of sleep-related erections.",2018,"There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
","['Circumcision Patients using Interrupted Rapid Eye Movement Sleep', 'Ninety participants who underwent male circumcision']","['interrupted rapid eye movement (IREM) sleep', 'Interrupted rapid eye movement sleep', 'interrupted rapid eye movement sleep group and the control group']","['incision swelling', 'times of sleep-related erection pain', 'moderate and severe pain', 'cumulative time of erection-related moderate and severe pain', 'Sleep time', 'sleep time', 'Erection Related Incision Pain', 'healing', 'incision swelling and healing']","[{'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}]","[{'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",90.0,0.0609254,"There were no significant differences in incision swelling (P = .768), healing (P = .626), and sleep time (P = .231).
","[{'ForeName': 'A-Juan', 'Initials': 'AJ', 'LastName': 'Dai', 'Affiliation': 'Division of anesthesia surgery, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China. dai_ajuan@163.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Soochow University, No.1 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Soochow University, No.1 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Soochow University, No.188 Shizi Street, Suzhou 215006, China.'}]",Urology journal,['10.22037/uj.v0i0.3981']
806,31624837,Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).,"OBJECTIVE


To examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA.
METHODS


Patients were randomized 1 : 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ⩾3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated.
RESULTS


One hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.",2020,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","['Patients', 'One hundred and thirty-one patients', 'active psoriatic arthritis', 'patients with active PsA']","['placebo', 'filgotinib', 'filgotinib or placebo', 'filgotinib 200 mg or placebo']","['HRQoL', 'health-related quality of life', 'PsAID9', 'SF-36', 'filgotinib achieved MCII']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}]",131.0,0.800834,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Rheumatology, Royal National Hospital for Rheumatic Diseases.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Meuleners', 'Affiliation': 'Biostatistics, Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Hendrikx', 'Affiliation': 'Medical Affairs, Galapagos BV, Leiden, Netherlands.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez408']
807,29290087,Does Mild Hydronephrosis Induced by Full-Bladder Improve Outcomes in Patients Undergoing Shock Wave Lithotripsy for Lower Calyceal Stones?: A Prospective Randomized Study.,"PURPOSE


To compare the outcomes, sessions and shock wave numbers in patients undergoing standard procedure shock wave lithotripsy (SWL) and patients undergoing SWL with mild hydronephrosis induced by full-bladderfollowing oral hydration before SWL procedure for lower calyceal stones.
MATERIALS AND METHODS


Between January 2014- January 2016 a total of 371 patients who underwent SWL, for lower pole calyceal stones ? 2 cm, were included into the study. 127 patients were treated in the supine position (Group A), 123 in the prone position (Group B) and 121 in the prone position with full bladder and mild hydronephrosis checked by ultrasound before procedure (Group C). There were 286 men and 85 women with a mean ± SD age of 36 ± 11 yearsResults: The mean (SD) stone sizes within the group A, group B and group C were 11 mm (±3 mm), 12 mm (±4.1 mm) and 11 mm (± 3.8 mm) respectively. No significant difference was found in age (P = .18) and stone size between 3 groups (P = .07). The median interquartile range (IQR) number of shocks within the group A, group B and group C were 7600 (3855), 6500 (4300) and 6700 (4915) respectively. Significant difference was found in number of shock waves among 3 groups (P < .01). The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
CONCLUSION


The present study suggests that mild hydronephrotic status induced by full-bladder before SWL can lower cost and patient discomfort by decrease in number of sessions and increase in stone clearance.",2018,"The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
","['Between January 2014- January 2016 a total of 371 patients who underwent SWL, for lower pole calyceal stones ', 'Patients Undergoing', 'patients undergoing standard procedure shock wave lithotripsy (SWL) and patients undergoing SWL with mild hydronephrosis induced by full-bladderfollowing oral hydration before SWL procedure for lower calyceal stones', '127 patients were treated in the supine position (Group A), 123 in the prone position (Group B) and 121 in the prone position with full bladder and mild hydronephrosis checked by ultrasound before procedure (Group C', '286 men and 85 women with a mean ± SD age of 36 ± 11 yearsResults']",['Shock Wave Lithotripsy'],"['stone expulsion rate', 'stone clearance', 'stone size', 'number of shock waves', 'median interquartile range (IQR) number of shocks', 'mean (SD) stone sizes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337815', 'cui_str': 'Poles (ethnic group)'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus (disorder)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0033422', 'cui_str': 'Prone Position'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0585032', 'cui_str': 'Before procedure (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",127.0,0.105074,"The difference between groups according to stone expulsion rate wasfound significant in all sessions (P = .01).
","[{'ForeName': 'Ismet Aydin', 'Initials': 'IA', 'LastName': 'Hazar', 'Affiliation': 'Department of Urology, Taksim Research and Training Hospital, Istanbul, Turkey. mdhazar@gmail.com.'}, {'ForeName': 'Basri', 'Initials': 'B', 'LastName': 'Cakiroglu', 'Affiliation': 'Department Urology, Hisar Intercontinental Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Sinanoglu', 'Affiliation': 'Department of Urology, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'Feride Sinem', 'Initials': 'FS', 'LastName': 'Akgün', 'Affiliation': 'Department of Emergency Clinic, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'Ersan', 'Initials': 'E', 'LastName': 'Arda', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Ilkan', 'Initials': 'I', 'LastName': 'Yuksel', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Akdere', 'Affiliation': 'Department of Urology, Trakya University, Edirne, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.3923']
808,31371810,Long-term intake of miso soup decreases nighttime blood pressure in subjects with high-normal blood pressure or stage I hypertension.,"The present study aimed to investigate the effects of the combination of Marukome Nenrin miso, which has natriuretic effects, and Marukome MK-34-1 miso, which has potent angiotensin converting enzyme inhibitory effects, on blood pressure (BP) in humans. A total of 40 subjects aged 40-69 years with high-normal BP or stage I hypertension were randomly assigned to two groups: 1) the miso group (32 g 2:1 w/w Nenrin and MK-34-1 with 3.8 g salt/day) or 2) the control soy food group (14.4 g soy food with 0.2 g salt/day). The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving. Daytime and nighttime BP were measured with an automated BP monitor. Compared with the soy food intake, miso intake for 8 weeks did not affect daytime clinical BP but significantly decreased nighttime BP without affecting pulse rate (PR). Moreover, miso shifted the nighttime BP profile to lower levels than those at baseline. Soy food intake did not change the nighttime BP profile after 8 weeks. Miso intake also tended to reduce nighttime BP in a subgroup with stage 1 hypertension compared with the results of the soy food group participants and shifted the nighttime BP profile toward lower levels than those recorded at baseline. Miso intake did not influence lipid or glucose metabolism. In conclusion, this is the first report showing that miso reduces nighttime BP in humans. Miso may do so by shrinking the fluid spaces in the body and/or deactivating the adrenergic nervous system.",2019,"The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving.","['humans', '40 subjects aged 40-69 years with high-normal BP or stage', 'subjects with high-normal blood pressure or stage I hypertension', 'I hypertension']",['miso group (32\u2009g 2:1 w/w Nenrin and MK-34-1 with 3.8\u2009g salt/day) or 2) the control soy food group (14.4\u2009g soy food with 0.2\u2009g salt/day'],"['levels of major nutrients', 'nighttime BP without affecting pulse rate (PR', 'daytime clinical BP', 'nighttime BP profile', 'nighttime blood pressure', 'lipid or glucose metabolism', 'Daytime and nighttime BP', 'nighttime BP', 'blood pressure (BP', 'nighttime BP profile toward lower levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0453222', 'cui_str': 'Miso'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C2919747', 'cui_str': 'Weight/weight ratio'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1258091', 'cui_str': 'Soy Foods'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",40.0,0.0318783,"The levels of major nutrients were equal in the miso and control food servings, except for the fiber and Na levels, which were higher in the miso food serving.","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Meiseikai Higashi Shinjuku Clinic, 3F Daito-bldg., 1-11-3 Okubo, Shinjuku-Ku, 169-0072, Japan.'}, {'ForeName': 'Hiroe', 'Initials': 'H', 'LastName': 'Sakuyama Tomari', 'Affiliation': ""Division of Clinical Nutrition, Faculty of Home Economics, Kyoritsu Women's University, Tokyo, Japan.""}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Yamakawa', 'Affiliation': ""Division of Clinical Nutrition, Faculty of Home Economics, Kyoritsu Women's University, Tokyo, Japan.""}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Minami', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Seiki', 'Initials': 'S', 'LastName': 'Itou', 'Affiliation': 'Marukome Co., Ltd, Nagano, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'TTC Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Food Therapeutic Lab, Tokyo, Japan. yoshiodr@nn.iij4u.or.jp.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0304-9']
809,29142136,"Size, Composition, and Evolution of HIV DNA Populations during Early Antiretroviral Therapy and Intensification with Maraviroc.","Residual viremia is common during antiretroviral therapy (ART) and could be caused by ongoing low-level virus replication or by release of viral particles from infected cells. ART intensification should impact ongoing viral propagation but not virion release. Eighteen acutely infected men were enrolled in a randomized controlled trial and monitored for a median of 107 weeks. Participants started ART with ( n  = 9) or without ( n  = 9) intensification with maraviroc (MVC) within 90 days of infection. Levels of HIV DNA and cell-free RNA were quantified by droplet digital PCR. Deep sequencing of C2-V3  env ,  gag , and  pol  (454 Roche) was performed on longitudinally collected plasma and peripheral blood mononuclear cell (PBMC) samples while on ART. Sequence data were analyzed for evidence of evolution by (i) molecular diversity analysis, (ii) nonparametric test for panmixia, and (iii) tip date randomization within a Bayesian framework. There was a longitudinal decay of HIV DNA after initiation of ART with no difference between MVC intensification groups (-0.08 ± 0.01 versus -0.09 ± 0.01 log 10  copies/week in MVC +  versus MVC -  groups;  P  = 0.62). All participants had low-level residual viremia (median, 2.8 RNA copies/ml). Across participants, medians of 56 (interquartile range [IQR], 36 to 74), 29 (IQR, 25 to 35), and 40 (IQR, 31 to 54) haplotypes were generated for  env ,  gag , and  pol  regions, respectively. There was no clear evidence of viral evolution during ART and no difference in viral diversity or population structure from individuals with or without MVC intensification. Further efforts focusing on elucidating the mechanism(s) of viral persistence in various compartments using recent sequencing technologies are still needed, and potential low-level viral replication should always be considered in cure strategies. IMPORTANCE  Residual viremia is common among HIV-infected people on ART. It remains controversial if this viremia is a consequence of propagating infection. We hypothesized that molecular evolution would be detectable during viral propagation and that therapy intensified with the entry inhibitor maraviroc would demonstrate less evolution. We performed a randomized double-blinded treatment trial with 18 acutely infected men (standard ART versus standard ART plus maraviroc). From longitudinally collected blood plasma and cells, levels of HIV DNA and cell-free HIV RNA were quantified by droplet digital PCR, and HIV DNA ( env ,  gag , and  pol  coding regions) was deep sequenced (454 Roche). Investigating people who started ART during the earliest stages of their HIV infection, when viral diversity is low, provides an opportunity to detect evidence of viral evolution. Despite using a battery of analytical techniques, no clear and consistent evidence of viral propagation for over 90 weeks of observation could be discerned.",2018,There was no clear evidence of viral evolution during ART and no difference in viral diversity or population structure from individuals with or without MVC intensification.,"['18 acutely infected men ', 'Eighteen acutely infected men']",['standard ART versus standard ART plus maraviroc'],"['low-level residual viremia', 'Size, Composition, and Evolution of HIV DNA Populations', 'viral evolution', 'Levels of HIV DNA and cell-free RNA', 'blood plasma and cells, levels of HIV DNA and cell-free HIV RNA']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3641730', 'cui_str': 'Circulating RNA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.244456,There was no clear evidence of viral evolution during ART and no difference in viral diversity or population structure from individuals with or without MVC intensification.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Chaillon', 'Affiliation': 'University of California San Diego, La Jolla, California, USA achaillon@ucsd.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gianella', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Lada', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Perez-Santiago', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Parris', 'Initials': 'P', 'LastName': 'Jordan', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ignacio', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Maile', 'Initials': 'M', 'LastName': 'Karris', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Richman', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Sanjay R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Little', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Joel O', 'Initials': 'JO', 'LastName': 'Wertheim', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Davey M', 'Initials': 'DM', 'LastName': 'Smith', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}]",Journal of virology,['10.1128/JVI.01589-17']
810,31628482,"A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.","OBJECTIVES


3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity.
METHODS


We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest.
RESULTS


Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns.
CONCLUSION


This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.",2020,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","['mildly active rheumatoid arthritis', 'hyperlipidaemia', 'patients with RA with', '64 RA patients with mild clinical disease activity but an elevated CRP']","['lovastatin', '3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins', 'lovastatin therapy', 'placebo', 'lovastatin vs placebo', 'Lovastatin']","['mean log CRP', 'CRP', 'hepatic and muscle toxicities', 'mean log CRP reduction', 'disease activity, RF and anti-CCP antibody titres', 'RA disease activity', 'disease activity', 'levels of serum cytokines']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4318437', 'cui_str': 'Anti-CCP'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.344131,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cush', 'Affiliation': 'Division of Rheumatology, Baylor University Medical Center, Dallas, USA.'}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': 'Division of Rheumatology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Striebich', 'Affiliation': 'Division of Rheumatology, University of Colorado, Denver, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'era"", 'Affiliation': 'Division of Rheumatology, University of California, San Francisco, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Olech', 'Affiliation': 'Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Box', 'Affiliation': 'Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keating', 'Affiliation': 'Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.'}, {'ForeName': 'Mary Chester', 'Initials': 'MC', 'LastName': 'Wasko', 'Affiliation': 'Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'St Clair', 'Affiliation': 'Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Weiquang', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'PetaGay', 'Initials': 'P', 'LastName': 'Ricketts', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'York', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez471']
811,31862277,The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial.,"BACKGROUND AND OBJECTIVES


Burn patients experience a high level of anxiety and poor sleep quality due to their special physical and psychological conditions. The present study aimed to investigate the effect of progressive muscle relaxation on anxiety and sleep quality in burn patients.
METHODOLOGY AND PARTICIPANTS


In this randomized controlled clinical trial, a total of 80 patients admitted to burn ward were enrolled using convenient sampling and randomly assigned to one of the experimental or control groups. In the experimental group, patients were intervened using Jacobson's relaxation technique 20-30min daily for three consecutive days. During this period, the control group received only routine care and treatment. Patients' anxiety and their sleep quality were measured and recorded before and after the intervention using the Spielberger State-Trait Anxiety Inventory (STAI) and St Mary's Hospital Sleep Quality Questionnaire (SMHSQ) respectively. Eventually, data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA).
RESULTS


The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05).
CONCLUSION


Relaxation as a complementary method can be used along with modern medicine to reduce anxiety and improve sleep quality in burn patients.",2020,"The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05).
","['80 patients admitted to burn ward', 'burn patients', 'Burn patients experience a high level of anxiety and poor sleep quality due to their special physical and psychological conditions']",['progressive muscle relaxation'],"['sleep quality', ""Spielberger State-Trait Anxiety Inventory (STAI) and St Mary's Hospital Sleep Quality Questionnaire (SMHSQ"", ""Patients' anxiety and their sleep quality"", 'anxiety', 'anxiety and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",80.0,0.0416758,"The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05).
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Masmouei', 'Affiliation': 'Faculty of Nursing, Department of Nursing, School of Nursing Hazrat Zahra(P.B.U.H) Abadeh, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.11.021']
812,29250762,Evaluation the result of warm normal saline irrigation in ureteral endoscopic surgeries.,"PURPOSE


Transurethral lithotripsy (TUL) is a major modality for the endoscopic management of ureteral stones. Ureteral spasm makes access for ureters difficult, which causes impaction of the ureteroscope, ureteral dislodge, and a low success rate of endoscopic surgeries. This study described the outcomes of a new endoscopic surgical experience by use of 40-degree warm saline irrigation during TUL compaired with routine ambient air irrigation in TUL.
MATERIALS AND METHODS


In this randomized clinical trial from 2014 to 2015, 150 patients with ureteral stone with balanced randomization were divided into two parallel groups. Patients underwent TUL in the first group with 20-25 degree saline irrigation and in the second group with 40-degree saline irrigation. One surgical team with the same semi-rigid instrument performed all TULs and the other steps were similar in both groups. Complete stone fragmentation was measured as the primary outcome and the duration of procedure, retrograde stone migration and all and any intraoperative complications were the secondary measurements.
RESULT


While comparing warm saline irrigation with cold saline irrigation, the rate of access to upper ureter was 95% versus 72%, stone retropulsion frequency was 10.7% versus 30.7% and the stone-free rate was 96% versus 76% respectively (P < .05). There was no ureteroscope impaction and ureteral dislodge in both groups.
CONCLUSION


Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.",2018,"Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.","['ureteral endoscopic surgeries', '2014 to 2015, 150 patients with ureteral stone with balanced randomization']","['warm normal saline irrigation', 'Transurethral lithotripsy (TUL', 'TUL', '40-degree saline irrigation', '40-degree warm saline irrigation', 'warm saline irrigation']","['rate of access to upper ureter', 'stone-free rate', 'ureteroscope impaction and ureteral dislodge', 'ureteral spasm rate, greater ureteral muscle relaxation', 'Complete stone fragmentation', 'duration of procedure, retrograde stone migration and all and any intraoperative complications', 'stone retropulsion frequency']","[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0184213', 'cui_str': 'Ureteroscopes'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C0948226', 'cui_str': 'Ureteral spasm'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",150.0,0.0491624,"Using warm saline irrigation in endoscopic surgeries results in better surgical outcomes including a lower ureteral spasm rate, greater ureteral muscle relaxation and better access to the upper ureteral zone, and a lower rate of complications, such as ureteroscope impaction, ureteral dislodge and stone retropulsion.","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mohammadzadeh Rezaei', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.. mohammadzadehma@mums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Akhavan Rezayat', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Tavakoli', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad-IRAN.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Department of Community Medicine, Mashhad University of Medical Sciences, Mashhad-IRAN.'}]",Urology journal,['10.22037/uj.v0i0.3872']
813,29277883,Effects of Different Anesthetic Agents on Surgical Site Hemorrhage During Circumcision.,"PURPOSE


To investigate the effects of ketamine+midazolam and propofol+sevoflurane anesthesia on surgical site hemorrhage during circumcision procedures.
MATERIALS AND METHODS


The boys undergoing circumcision surgery were included in the study. The patients were divided into two groups. In Group 1 (n = 50), 0.01 mg/kg midazolam and 2 mg/kg IV ketamine were administered. In Group 2 (n = 50), 1 ?g/kg fentanyl, 1 mg/kg lidocaine 2%, and 2-3 mg/kg IV propofol were administered, and patency of airway was ensured with a laryngeal mask airway. The intraoperative bleeding scale was recorded during the procedure to evaluate surgical site bleeding. Hemorrhage was checked for the first three hours using the postoperative bleeding scale to follow the amount of hemorrhage.
RESULTS


Intraoperative bleeding scores were significantly higher in Group 1 as compared to Group 2. However, there was no significant difference between the groups regarding frequency of postoperative hemorrhage. Themean blood pressure values measured at 5th, 10th, 15th minutes and recovery room were significantly higher in Group 1.
CONCLUSION


The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane. On the other hand this hemorrhage can be controlled easily with appropriate hemostasis, and the amount of blood loss was not clinically significant. We think that our study makes a positive contribution to the literature about the effects of anesthetics on the surgical site bleeding during circumcision.
CLINICAL TRIALS REGISTRATION


ACTRN12616000189426.",2018,The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane.,"['boys undergoing circumcision surgery', 'Surgical Site Hemorrhage During Circumcision']","['ketamine', 'ketamine+midazolam', 'midazolam', 'lidocaine', 'ketamine+midazolam and propofol+sevoflurane anesthesia', 'propofol+sevoflurane']","['Intraoperative bleeding scores', 'blood loss', 'Themean blood pressure values', 'Hemorrhage', 'postoperative bleeding scale', 'surgical site hemorrhage', 'intraoperative bleeding scale', 'frequency of postoperative hemorrhage', 'intraoperative bleeding scores']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}]",50.0,0.0356675,The intraoperative bleeding scores were significantly higher with ketamine+midazolam compared to propofol+sevoflurane.,"[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Karasu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey. drderyatopuz@gmail.com.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}, {'ForeName': 'Seyda Efsun', 'Initials': 'SE', 'LastName': 'Ozgunay', 'Affiliation': 'Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}, {'ForeName': 'Isra', 'Initials': 'I', 'LastName': 'Karaduman', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gaziemir Government Hospital, Izmir 35410, Turkey.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Ozer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Savsat Government Hospital, Artvin 08700, Turkey.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Kaya', 'Affiliation': 'Department of Pediatric Surgery, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa 16290, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.3882']
814,31628486,An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs.,"OBJECTIVES


The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response.
METHODS


Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units).
RESULTS


A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission.
CONCLUSION


Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.",2020,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","['RA patients', 'Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible', 'A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45']","['certolizumab pegol added to conventional synthetic DMARDs (csDMARDs', 'certolizumab pegol combined with DMARDs', 'ΔDAS28', 'continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO']","['RF status or prior biologics', 'rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement', 'non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity', 'DAS28 low disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",88.0,0.172243,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Department of Medicine, University of Western Ontario, ON.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Rampakakis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vaillancourt', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Department of Medicine, Laval University, Québec, QC.'}, {'ForeName': 'Juris', 'Initials': 'J', 'LastName': 'Lazovskis', 'Affiliation': 'Department of Medicine, Dalhousie University, Saint John, NB.'}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': 'Institut de Rhumatologie de Montréal, Montréal, QC.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sampalis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez470']
815,31609297,Cognitive Impairment during High-Intensity Exercise: Influence of Cerebral Blood Flow.,"PURPOSE


Cognitive performance appears to be impaired during high-intensity exercise, and this occurs concurrently with a reduction in cerebral blood flow (CBF). However, it is unclear whether cognitive impairment during high-intensity exercise is associated with reduced CBF. We tested the hypothesis that a reduction in CBF is responsible for impaired cognitive performance during high-intensity exercise.
METHODS


Using a randomized crossover design 17 healthy males performed spatial delayed response and Go/No-Go tasks in three conditions (exercise [EX], exercise+CO2 [EX+CO2], and a nonexercising control [CON]). In the EX and EX+CO2, they performed cognitive tasks at rest and during 8 min of moderate and high-intensity exercise. Exercise intensity corresponded to ~50% (moderate) and ~80% (high) of peak oxygen uptake. In the EX+CO2, the participants inspired hypercapnic gas (2% CO2) during high-intensity exercise. In the CON, they performed the cognitive tasks without exercise.
RESULTS


Middle cerebral artery mean velocity increased during high-intensity exercise in the EX+CO2 relative to the EX (69.4 [10.6] cm·s, vs 57.2 [7.7] cm·s, P < 0.001). Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX (84.1% [13.3%], P < 0.05) and the EX+ CO2 (85.7 [11.6%], P < 0.05) relative to rest (EX: 95.1% [5.3%], EX+CO2: 95.1 [5.3%]). However, no differences between the EX and the EX+CO2 were observed (P > 0.10). These results demonstrate that restored CBF did not prevent cognitive impairment during high-intensity exercise.
CONCLUSIONS


We conclude that a reduction in CBF is not responsible for impaired cognitive performance during high-intensity exercise.",2020,"Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX [84.1 (13.3) %, P < 0.05] and the EX+CO2 [85.7 (11.6) %, P < 0.05] relative to rest [EX: 95.1 (5.3) %,",['seventeen healthy males performed spatial delayed-response (DR) and Go'],"['conditions [Exercise (EX), Exercise+CO2 (EX+CO2', 'High-Intensity Exercise', 'EX+CO2']","['Accuracy of the cognitive tasks', 'cognitive impairment', 'peak oxygen uptake', 'Cerebral Blood Flow', 'Middle cerebral artery mean velocity (MCAv', 'EX+CO2', 'Exercise intensity', 'cerebral blood flow (CBF', 'Cognitive Impairment']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",17.0,0.0392428,"Accuracy of the cognitive tasks was impaired during high-intensity exercise in the EX [84.1 (13.3) %, P < 0.05] and the EX+CO2 [85.7 (11.6) %, P < 0.05] relative to rest [EX: 95.1 (5.3) %,","[{'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Komiyama', 'Affiliation': 'Graduate School of Sports and Health Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Yukiya', 'Initials': 'Y', 'LastName': 'Tanoue', 'Affiliation': 'Graduate School of Sports and Health Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Sudo', 'Affiliation': 'Meiji Yasuda Life Foundation of Health and Welfare, Tokyo, JAPAN.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'Extreme Environments Laboratory, Department of Sport and Exercise Science, University of Portsmouth, Portsmouth, UNITED KINGDOM.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Uehara', 'Affiliation': 'Faculty of Sports Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Higaki', 'Affiliation': 'Faculty of Sports Science, Fukuoka University, Fukuoka, JAPAN.'}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, Tokyo, JAPAN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002183']
816,26174493,Kappa Antagonist JDTic in Phase 1 Clinical Trial.,,2015,,[],[],[],[],[],[],,0.0296434,,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chavkin', 'Affiliation': 'Department of Pharmacology, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, NY, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/npp.2015.74']
817,31416744,Effectiveness of a mindfulness-based psychoeducation group programme for early-stage schizophrenia: An 18-month randomised controlled trial.,"Current psychosocial interventions in schizophrenia are evidenced to improve patients' illness-related knowledge, mental status and relapse rate, but substantive benefits to patients, such as their functioning and insight into the illness, remain uncertain. This multi-centre randomised clinical trial aimed to examine the effects of mindfulness-based psycho-education group intervention for adult patients with early-stage schizophrenia over an 18-month follow-up. The controlled trial was conducted with a repeated-measure, three-arm design at two psychiatric outpatient clinics in Jilin (China) and Hong Kong. A stratified random sample of 180 outpatients with schizophrenia spectrum disorders (60/group) was randomly assigned to a mindfulness-based psycho-education group programme, psycho-education group and treatment-as-usual group. The primary outcomes on patients' psychosocial functioning and other patient outcomes, such as psychotic symptoms, in the three groups were compared over the 18-month follow-up (baseline and 1-week, 9-month and 18-month post-intervention). One hundred and sixty (89%) patients completed at least two post-tests. Their mean age and duration of illness were 25-28 years (SD = 6.1-7.8) and 2.1-2.5 years (SD = 1.3-2.0; range 4-54 months), respectively. Compared with the two other groups, the mindfulness-based group exhibited a significantly greater improvement with moderate to large effect sizes (Cohen's d = 0.49-0.98) in functioning (p = 0.005), duration of psychiatric re-hospitalisations (p = 0.007), psychotic symptoms (p = 0.008) and illness insight (p = 0.001) over the 18-month follow-up. Supplementary MRI findings indicated that the mindfulness-based intervention resulted in significant changes in gray matter volume and density in brain regions concerning attention and emotional regulation. Mindfulness-oriented psycho-education group intervention can be an effective intervention for adults with early-stage schizophrenia and exert long-term effects on patients' functioning and mental conditions.",2019,"Compared with the two other groups, the mindfulness-based group exhibited a significantly greater improvement with moderate to large effect sizes (Cohen's d = 0.49-0.98) in functioning (p = 0.005), duration of psychiatric re-hospitalisations (p = 0.007), psychotic symptoms (p = 0.008) and illness insight (p = 0.001) over the 18-month follow-up.","['adult patients with early-stage schizophrenia over an 18-month follow-up', 'One hundred and sixty (89', '180 outpatients with schizophrenia spectrum disorders (60/group', 'early-stage schizophrenia', 'Their mean age and duration of illness were 25-28\u202fyears (SD\u202f=\u202f6.1-7.8) and 2.1-2.5\u202fyears (SD\u202f=\u202f1.3-2.0; range 4-54\u202fmonths), respectively', 'two psychiatric outpatient clinics in Jilin (China) and Hong Kong', ""adults with early-stage schizophrenia and exert long-term effects on patients' functioning and mental conditions""]","['mindfulness-based psychoeducation group programme', 'Mindfulness-oriented psycho-education group intervention', 'mindfulness-based psycho-education group intervention', 'mindfulness-based psycho-education group programme, psycho-education group and treatment-as-usual group']","[""patients' psychosocial functioning and other patient outcomes, such as psychotic symptoms"", 'duration of psychiatric re-hospitalisations', 'gray matter volume and density in brain regions concerning attention and emotional regulation', 'illness insight', 'psychotic symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0023983', 'cui_str': 'Effects, Long-Term'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}]",180.0,0.178526,"Compared with the two other groups, the mindfulness-based group exhibited a significantly greater improvement with moderate to large effect sizes (Cohen's d = 0.49-0.98) in functioning (p = 0.005), duration of psychiatric re-hospitalisations (p = 0.007), psychotic symptoms (p = 0.008) and illness insight (p = 0.001) over the 18-month follow-up.","[{'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China. Electronic address: wtchien@cuhk.edu.hk.'}, {'ForeName': 'Ho Yu', 'Initials': 'HY', 'LastName': 'Cheng', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.'}, {'ForeName': 'Terry W', 'Initials': 'TW', 'LastName': 'McMaster', 'Affiliation': 'Department of Psychology, Concordia University, Montreal H4B 1R6, Quebec, Canada.'}, {'ForeName': 'Annie L K', 'Initials': 'ALK', 'LastName': 'Yip', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, China.'}, {'ForeName': 'JoJo C L', 'Initials': 'JCL', 'LastName': 'Wong', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.'}]",Schizophrenia research,['10.1016/j.schres.2019.07.053']
818,31603241,Inhaled nitric oxide for treating pain crises in people with sickle cell disease.,"BACKGROUND


In people with sickle cell disease, sickled red blood cells cause the occlusion of small blood vessels which presents as episodes of severe pain known as pain crises or vaso-occlusive crises. The pain can occur in the bones, chest, or other parts of the body, and may last several hours to days. Pain relief during crises includes both pharmacologic and non-pharmacologic treatments. The efficacy of inhaled nitric oxide in pain crises has been a controversial issue and hypotheses have been made suggesting a beneficial response due to its vasodilator properties. Yet no conclusive evidence has been presented.This review aims to evaluate the available randomised controlled studies which address this topic.
OBJECTIVES


To capture the available body of evidence evaluating the efficacy and safety of the use of inhaled nitric oxide in treating pain crises in people with sickle cell disease; and to assess the treatment's relevance, robustness, and validity, in order to better guide medical practice in the fields of haematology and palliative care (since recent literature seems to favour the involvement of palliative care for those people).
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register. Unpublished work is identified by searching the abstract books of the European Haematology Association conference; the American Society of Hematology conference; the British Society for Haematology Annual Scientific Meeting; the Caribbean Health Research Council Meetings; and the National Sickle Cell Disease Program Annual Meeting.Date of most recent search: 19 September 2019.We also searched ongoing study registries, date of most recent search: 26 September 2019.
SELECTION CRITERIA


Randomised and quasi-randomised trials comparing inhaled nitric oxide with placebo, or standardized way of treatment of pain crises in people with sickle cell disease.
DATA COLLECTION AND ANALYSIS


Two authors independently assessed trial quality and extracted data (including adverse event data). A third author helped clarify any disagreement. When the data were not reported in the text, we attempted to extract the data from any table or figure available. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE criteria MAIN RESULTS: We identified six trials, three of which (188 participants) were eligible for inclusion in the review. There were equal numbers of males and females; and most participants were adults, although one small trial was conducted in a children's hospital and recruited children over the age of 10 years. All three parallel trials compared inhaled nitric oxygen (80 ppm) to placebo (room air) for four hours; one trial continued administering nitric oxide (40 ppm) for a further four hours. This extended trial had an overall low risk of bias; however, in the remaining two trials we had concerns about the risk of bias from the small sample size and additionally a high risk of bias due to financial conflicts of interest in one of these smaller trials. We were only able to analyse some limited data from the eight-hour trial and report the remaining results narratively.The time to pain resolution was only reported in one trial (150 participants), showing there may be little or no difference between the two groups: with inhaled nitric oxide median 73.0 hours (95% confidence interval (CI) 46.0 to 91.0) and with placebo median 65.5 hours (95% CI 48.1 to 84.0) (low-quality evidence). No trial reported on the duration of the initial pain crisis. Only one large trial reported on the frequency of pain crises in the follow-up period and found there may be little or no difference between the inhaled nitric oxide and placebo groups for a return to the ED, risk ratio 0.73 (95% CI 0.31 to 1.71) or for re-hospitalisation, risk ratio 0.53 (95% CI 0.25 to 1.11) (150 participants; low-quality evidence).There may be little or no difference between treatment and placebo in terms of reduction in pain score at any time point up to eight hours (150 participants). The two smaller trials reported a beneficial effect of inhaled nitric oxide in reducing the visual analogue pain score after four hours of the intervention, but these trials were small and limited compared to the first trial.Analgesic use was reported not to differ greatly between the inhaled nitric oxide group and placebo group in any of the three trials, but no analysable data were provided. The median duration of hospitalisation was reported by two trials, in the largest trial the placebo group had the shorter duration and in the second smaller (paediatric) trial hospitalisation was shorter in the treatment group.Only the largest trial (150 participants) reported serious adverse events, with no increase in the inhaled nitric oxide group during or after the intervention compared to the control group (acute chest syndrome occurred in 5 out of 75 participants from each group, pyrexia in 1 out of 75 participants from each group, dysphagia and a drop in haemoglobin were each reported in 1 out of 75 participants in the inhaled nitric oxide group, but not in the placebo group) (low-quality evidence).
AUTHORS' CONCLUSIONS


The currently available trials do not provide sufficient evidence to determine the effects (benefits or harms) of using inhaled nitric oxide to treat pain (vaso-occlusive) crises in people with sickle cell disease. Large-scale, long-term trials are needed to provide more robust data in this area. Patient-important outcomes (e.g. measures of pain and time to pain resolution and amounts of analgesics used), as well as use of healthcare services should be measured and reported in a standardized form.",2019,"Analgesic use was reported not to differ greatly between the inhaled nitric oxide group and placebo group in any of the three trials, but no analysable data were provided.","['188 participants) were eligible for inclusion in the review', 'people with sickle cell disease', ""children's hospital and recruited children over the age of 10 years"", 'pain crises']","['inhaled nitric oxide with placebo', 'inhaled nitric oxygen', 'Inhaled nitric oxide', 'placebo', 'inhaled nitric oxide', 'nitric oxide']","['time to pain resolution', 'pain score', 'median duration of hospitalisation', 'serious adverse events', 'pain and time to pain resolution and amounts of analgesics used), as well as use of healthcare services', 'pyrexia', 'shorter duration and in the second smaller (paediatric) trial hospitalisation', 'trial quality and extracted data (including adverse event data', 'visual analogue pain score', 'duration of the initial pain crisis', 'dysphagia and a drop in haemoglobin', 'frequency of pain crises', 'Analgesic use', 'Pain relief', 'pain crises']","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis (finding)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557829', 'cui_str': 'Healthcare services (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis (finding)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",188.0,0.394163,"Analgesic use was reported not to differ greatly between the inhaled nitric oxide group and placebo group in any of the three trials, but no analysable data were provided.","[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Aboursheid', 'Affiliation': 'Internal Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Albaroudi', 'Affiliation': ''}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Alahdab', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011808.pub2']
819,31600804,Epidural versus PCA Pain Management after Pectus Excavatum Repair: A Multi-Institutional Prospective Randomized Trial.,"INTRODUCTION


Postoperative pain control remains the primary reason for inpatient stay after minimally invasive repair of pectus excavatum. In a previous study, our group reported that early pain control was better in patients managed with a thoracic epidural, while late pain control was better in patients managed with patient-controlled analgesia (PCA). After revising our epidural transition and modifying the PCA protocol, we conducted a multi-institutional prospective randomized trial to evaluate these two pain control strategies.
MATERIALS AND METHODS


Patients were randomized to epidural or PCA following minimally invasive repair of pectus excavatum with standard protocols for each arm. Primary outcome was length of stay with secondary variables including mean patient pain scores, complications, and parental satisfaction. Scores were pooled for the two groups and reported as means with standard deviation. Results were compared using  t -tests and one-way analysis of variance with  p -value < 0.05 determining significance.
RESULTS


Sixty-five patients were enrolled, 32 epidural and 33 PCA. Enrollment was stopped early when we developed an alternative strategy for controlling these patients' pain. There was no difference in length of stay in hours between the two arms; epidural 111.3 ± 18.5 versus PCA 111.4 ± 51.4,  p  = 0.98. Longer operative time was found in the epidural group. Nine patients in the epidural group (28%) required a PCA in addition to epidural for adequate pain control. Mean pain scores were lower on postoperative day 0 in the epidural group compared with the PCA groups, but were otherwise similar.
CONCLUSION


In our prospective randomized trial, PCA is just as effective as thoracic epidural in decreasing early postoperative pain scores after minimally invasive repair of pectus excavatum.",2020,"Mean pain scores were lower on postoperative day 0 in the epidural group compared with the PCA groups, but were otherwise similar.
","['after Pectus Excavatum Repair', 'Sixty-five patients were enrolled, 32 epidural and 33 PCA', 'Patients']","['PCA', 'Epidural versus PCA Pain Management', 'epidural or PCA']","['postoperative pain scores', 'length of stay', 'length of stay with secondary variables including mean patient pain scores, complications, and parental satisfaction', 'Mean pain scores', 'late pain control', 'Longer operative time', 'early pain control']","[{'cui': 'C0016842', 'cui_str': 'Pectus Excavatum'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",65.0,0.186949,"Mean pain scores were lower on postoperative day 0 in the epidural group compared with the PCA groups, but were otherwise similar.
","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sujka', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dekonenko', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Millspaugh', 'Affiliation': ""Department of Anesthesiology, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States.""}, {'ForeName': 'Nichole M', 'Initials': 'NM', 'LastName': 'Doyle', 'Affiliation': ""Department of Anesthesiology, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Walker', 'Affiliation': 'Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin, United States.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Leys', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, United States.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Ostlie', 'Affiliation': ""Department of Surgery, Phoenix Children's Hospital, Phoenix, Arizona, United States.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aguayo', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Fraser', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Alemayehu', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}, {'ForeName': 'Shawn D St', 'Initials': 'SDS', 'LastName': 'Peter', 'Affiliation': ""Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri, United States.""}]",European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie,['10.1055/s-0039-1697911']
820,31600368,Month 24 Outcomes After Treatment Initiation With Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial.,"Importance


Two-year outcomes are reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor (VEGF) therapy for macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO) from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial.
Objective


To investigate outcomes 1 year after cessation of the SCORE2 treatment schedule.
Design, Setting, and Participants


In this secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between September 17, 2014, and November 18, 2015. Data for the analyses were frozen on September 13, 2018.
Interventions


SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion, and underwent assessment at month 24.
Main Outcomes and Measures


Visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography.
Results


Among 362 participants randomized to aflibercept or bevacizumab, 65.2% (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8% male). The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99% CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99% CI, -5.6 to 5.3) at month 24. The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference, 26 μm; 99% CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99% CI, -58 to 78 μm) at month 24.
Conclusions and Relevance


No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. Caution in interpretation is needed because of loss to follow-up. In both groups, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. This analysis suggests that CRVO and HRVO warrant close monitoring and treatment as needed over at least 2 years to optimize outcomes in eyes treated with anti-VEGF therapy.
Trial Registration


ClinicalTrials.gov identifier: NCT01969708.",2019,"Conclusions and Relevance


No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab.","['Macular Edema', ' 65.2% (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12.0) years; 53.8% male', 'between September 17, 2014, and November 18, 2015', '362 participants randomized to', '117 participants originally randomized to aflibercept and 119 participants originally randomized to']","['Central Retinal or Hemiretinal Vein Occlusion', 'Anti-Vascular Endothelial Growth Factor Therapy', 'bevacizumab', 'aflibercept or bevacizumab']","['mean (SD) CST', 'mean (SD) VALS', 'VALS and CST', 'Measures\n\n\nVisual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography']","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1735356', 'cui_str': 'Hemiretinal vein occlusion'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C1529218', 'cui_str': 'Vals'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]",117.0,0.210116,"Conclusions and Relevance


No differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab.","[{'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'VanVeldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, UCLA (University of California, Los Angeles).'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison.'}, {'ForeName': 'Clement K', 'Initials': 'CK', 'LastName': 'Chan', 'Affiliation': 'Southern California Desert Retina, Palm Desert.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.3947']
821,28820855,Resistance exercise order does not affect the magnitude and duration of post-exercise blood pressure in older women.,"The aim of this study was to compare the effects of two resistance exercise order on post-exercise blood pressure (BP) in trained, non-hypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise. Blood pressure and heart rate were obtained pre and post-sessions (60 min). Post-exercise hypotension was observed for systolic and mean BP in both the MS session (systolic BP: -6.9 mmHg, mean BP: -3.3 mmHg, P< 0.05) and SM session (systolic BP: -4.6 mmHg; mean BP: -1.1 mmHg). Post-exercise heart rate was higher than pre-session values until 30 min of recovery in both training sessions. Furthermore, systolic and mean blood pressure, and heart rate were lower than the values obtained in the control session (30 to 60 min and 0 min, respectively; P<0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of post-exercise hypotension in trained, non-hypertensive older women.",2017,There were no differences between the SM and MS sessions in any variable or at any moment.,"['Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed two', 'trained, non-hypertensive older women', 'older women', 'hypertensive older women']","['resistance exercise order on post-exercise blood pressure (BP', 'Resistance exercise', 'sessions witheight exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multi-joint exercises [SM]) and a control session, without exercise']","['Post-exercise heart rate', 'Furthermore, systolic and mean blood pressure, and heart rate', 'Blood pressure and heart rate', 'magnitude and duration of post-exercise blood pressure', 'systolic and mean BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0338416,There were no differences between the SM and MS sessions in any variable or at any moment.,"[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'a Metabolism, Nutrition, and Exercise Laboratory. Londrina State University. Londrina, Brazil. b Department of Physical Education, Federal University of Vale do São Francisco, Petrolina, Brazil. c Department of Physical Education, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil. d Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Gerage', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': ''}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': ''}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177']
822,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
823,31592728,Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.,"BACKGROUND


In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.
METHODS AND RESULTS


Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.
CONCLUSIONS


With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.",2019,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","['patients with iliofemoral DVT', 'Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis', 'patients with acute deep vein thrombosis (DVT', '692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355', 'Patients With Proximal Deep Vein Thrombosis']","['Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis', 'Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['costs', 'Cost-Effectiveness', 'Utility scores', 'mean costs of the initial procedure', 'lifetime costs', 'Health state utilities', 'index hospitalization', 'incremental cost-effectiveness ratio for PCDT', 'lifetime incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",692.0,0.13536,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Khaja', 'Initials': 'K', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology (J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.Z.G.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Newton-Wellesley Hospital, Newton, MA (M.R.J.).'}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Interventional Institute at Holy Name Medical Center, Teaneck, NJ (K.H.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Brady', 'Affiliation': 'Thomas Jefferson University and Einstein Health Care Network, Philadelphia, PA (P.S.B.).'}, {'ForeName': 'Karun', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ""Children's National Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC (K.S.).""}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Black', 'Affiliation': 'Utah Valley Hospital/Intermountain Healthcare and IVC Vein and Interventional Center, Provo (C.M.B.).'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005659']
824,31599661,Altering meal timing to improve cognitive performance during simulated nightshifts.,"Altering meal timing could improve cognition, alertness, and thus safety during the nightshift. This study investigated the differential impact of consuming a meal, snack, or not eating during the nightshift on cognitive performance (ANZCTR12615001107516). 39 healthy participants (59% male, age mean±SD: 24.5 ± 5.0y) completed a 7-day laboratory study and underwent four simulated nightshifts. Participants were randomly allocated to: Meal at Night (MN;  n=  12), Snack at Night (SN;  n  = 13) or No Eating at Night (NE;  n  = 14). At 00:30 h, MN consumed a meal and SN consumed a snack (30% and 10% of 24 h energy intake respectively). NE did not eat during the nightshift. Macronutrient intake was constant across conditions. At 20:00 h, 22:30 h, 01:30 h, and 04:00 h, participants completed the 3-min Psychomotor Vigilance Task (PVT-B), 40-min driving simulator, post-drive PVT-B, subjective sleepiness scale, 2-choice Reaction Time task, and Running Memory task. Objective sleep was recorded for each of the day sleeps using Actigraphy and for the third day sleep, Polysomnography was used. Performance was compared between conditions using mixed model analyses. Significant two-way interactions were found. At 04:00 h, SN displayed increased time spent in the safe zone ( p  < .001; percentage of time spent within 10 km/h of the speed limit and 0.8 m of lane center), and decreases in speed variability ( p  < .001), lane variability ( p  < .001), post-drive PVT-B lapses (defined as RT > 355 ms;  p  < .001), and reaction time on the 2-choice reaction time task ( p  < .001) and running memory task ( p  < .001) compared to MN and NE. MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE. There was no difference in objective sleep between eating conditions. Eating a large meal during the nightshift impairs cognitive performance and sleepiness above the effects of time of night alone. For improved performance, shiftworkers should opt for a snack at night.",2019,MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE.,"['39 healthy participants (59% male, age mean±SD: 24.5\xa0±\xa05.0y) completed a 7-day laboratory study and underwent four simulated nightshifts']","['Meal at Night (MN;  n=\xa0 12), Snack at Night (SN;  n  =\xa013) or No Eating at Night (NE', 'NE']","['reaction time on the 2-choice reaction time task', 'cognition, alertness', '3-min Psychomotor Vigilance Task (PVT-B), 40-min driving simulator, post-drive PVT-B, subjective sleepiness scale, 2-choice Reaction Time task, and Running Memory task', 'running memory task', 'time spent', 'cognitive performance', 'Macronutrient intake', 'post-drive PVT-B lapses', 'objective sleep', 'Objective sleep', 'speed variability', 'lane variability', 'subjective sleepiness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",39.0,0.0365096,MN reported greater subjective sleepiness at 04:00 h ( p  < .001) compared to SN and NE.,"[{'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Centofanti', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dorrian', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Coates', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Stepien', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute and Adelaide School of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Heilbronn', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Food and Nutrition Flagship, Commonwealth Scientific and Industrial Research Organization, Adelaide, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Coro', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Dilushi', 'Initials': 'D', 'LastName': 'Chandrakumar', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Behaviour-Brain-Body Research Centre, School of Psychology, Social Work and Social Policy, University of South Australia, Adelaide, Australia.'}]",Chronobiology international,['10.1080/07420528.2019.1676256']
825,31328311,Pressure-guided second-generation cryoballoon pulmonary vein isolation: Prospective comparison of the procedural and clinical outcomes with the conventional strategy.,"BACKGROUND


The utility of pressure waveform analyses to assess pulmonary vein (PV) occlusions has been reported in cryoballoon PV isolation (CB-PVI) using first-generation CBs. This prospective randomized study compared the procedural and clinical outcomes of pressure-guided and conventional CB-PVI.
METHODS AND RESULTS


Sixty patients with paroxysmal atrial fibrillation underwent CB-PVI with 28-mm second-generation CBs. PV occlusions were assessed either by real-time pressure waveforms without contrast utilization (pressure-guided group) or contrast injections (conventional group) and randomly assigned. Before the randomization, 24 patients underwent pressure-guided CB-PVIs. In the derivation study, a vein occlusion was obtained in 88/96 (91.7%) PVs among which 86 (97.7%) were successfully isolated by the application. In the validation study, the nadir balloon temperature and total freezing time did not significantly differ per PV between the two groups. The positive predictive value of the vein occlusion for predicting successful acute isolations was similar (93 of 103 [90.2%] and 89 of 98 [90.8%] PVs; P = 1.000), but the negative predictive value was significantly higher in pressure-guided than angiographical occlusions (14 of 17 [82.3%] vs 7 of 22 [31.8%]; P = .003). Both the procedure (57.7 ± 14.2 vs 62.6 ± 15.8 minutes; P = .526) and fluoroscopic times (16.3 ± 6.4 vs 20.1 ± 6.1; P = .732) were similar between the two groups, however, the fluoroscopy dose (130.6 ± 97.7 vs 353.2 ± 231.4 mGy; P < .001) and contrast volume used (0 vs 17.5 ± 7.7 mL; P < .001) were significantly smaller in the pressure-guided than conventional group. During 27.8 (5-39) months of follow-up, the single procedure arrhythmia freedom was similar between the two groups (P = .438).
CONCLUSIONS


Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs. This technique required no contrast utilization and significantly reduced radiation exposure more than conventional CB-PVIs.",2019,"CONCLUSIONS


Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs.","['24 patients underwent pressure-guided CB-PVIs', 'Sixty patients with paroxysmal atrial fibrillation underwent CB-PVI with 28-mm second-generation CBs']","['real-time pressure waveforms without contrast utilization (pressure-guided group) or contrast injections (conventional group', 'Pressure-guided second-generation cryoballoon pulmonary vein isolation', 'pressure-guided and conventional CB-PVI']","['nadir balloon temperature and total freezing time', 'single procedure arrhythmia freedom', 'fluoroscopic times', 'successful acute isolations', 'vein occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449980', 'cui_str': 'Pressure waveform (attribute)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}]",60.0,0.05328,"CONCLUSIONS


Pressure-guided second-generation CB-PVIs were similarly effective and as safe as conventional CB-PVIs.","[{'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kaseno', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Hisazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Amaya', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Miyahara', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Aiki', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Moe', 'Initials': 'M', 'LastName': 'Mukai', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Matsui', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Daisetsu', 'Initials': 'D', 'LastName': 'Aoyama', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Shiomi', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Tama', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ikeda', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Morishita', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Uzui', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14080']
826,31073283,Feasibility and Acceptability of a Motivational Intervention Combined with Text Messaging for Alcohol and Sex Risk Reduction with Emergency Department Patients: A Pilot Trial.,"Background


Interventions aimed at reducing co-occurring heavy drinking and risky sexual behavior among Emergency Department (ED) patients require feasibility and acceptability to optimally engage individuals.
Objectives


This pilot study explored the feasibility and acceptability of an interactive text-messaging (TM) supplement to a brief in-person intervention previously found successful in reducing alcohol use and condomless sex.
Methods


Using a mixed-method design, ED patients with past hazardous alcohol use and condomless sex ( N = 20) were randomly assigned to receive either a Motivational Intervention + TM or Brief Advice + TM. All participants completed exit interviews at four weeks follow-up, and transcripts were transcribed and coded to identify themes. We evaluated feasibility through quantitative assessment of TM response rates and latency to response, while acceptability was evaluated through thematic analysis of exit interviews.
Results


Findings provide support for the delivery of an integrated and personalized MI and TM. Participants engaged positively with the TM intervention and qualitative interviews offered strong support for the acceptability while offering information necessary to enhance the TM component.
Conclusions


Integrating MI with TM is feasible and acceptable to at-risk ED patients and could facilitate behavior changes beyond MI alone.",2019,"Participants engaged positively with the TM intervention and qualitative interviews offered strong support for the acceptability while offering information necessary to enhance the TM component.
","['Emergency Department Patients', ' N = 20', 'ED patients with past hazardous alcohol use and condomless sex']","['Motivational Intervention Combined with Text Messaging', 'Motivational Intervention + TM or Brief Advice + TM', 'interactive text-messaging (TM) supplement', '\n\n\nInterventions aimed at reducing co-occurring heavy drinking and risky sexual behavior among Emergency Department (ED']","['TM response rates and latency to response, while acceptability', 'Feasibility and Acceptability']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0412893,"Participants engaged positively with the TM intervention and qualitative interviews offered strong support for the acceptability while offering information necessary to enhance the TM component.
","[{'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, PO Box 6000, Binghamton, NY 13902.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Celio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA 15261.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Box G-S121-5, Providence, RI 02912.'}]",Addiction research & theory,['10.1080/16066359.2018.1444159']
827,31566476,"The effect of arm-crank exercise training on power output, spirometric and cardiac function and level of autonomy in persons with tetraplegia.","Studies on the effects of exercise training in persons with cervical spinal cord injury (CSCI) are scarce. The aim of this study was to determine the effect of an 8-week stationary arm-crank exercise (ACE) training programme on the level of autonomy, exercise performance, pulmonary functional parameters and resting heart rate variability (HRV) in persons with CSCI. Quadriplegia Index of Function (QIF), arm-crank peak power output (Ppeak), spirometric variables, and HRV indices were measured before and after the training programme in a group of 11 persons with CSCI. ACE training increased Ppeak in both groups ( p  < 0.05), whereas maximum voluntary ventilation (MVV) and low frequency HRV (LF) improved only in the lower CSCI group ( p  < 0.05). Moreover, QIF and Ppeak were significantly correlated before ( r  = 0.88;  p  < 0.01) and after ( r  = 0.86;  p  < 0.01) the training period. However, no significant changes were found in the level of autonomy (QIF) as a result of the intervention. Therefore, stationary ACE training appears to be a feasible and effective method for aerobic exercise in persons with tetraplegia and a short-term intervention is able to significantly improve exercise capacity, cardiac autonomic regulation and respiratory muscle endurance, regardless of the absence of significant immediate changes in the level of autonomy.",2020,"ACE training increased Ppeak in both groups (p<0.05), whereas maximum voluntary ventilation (MVV) and low frequency HRV (LF) improved only in the lower CSCI group (p<0.05).","['persons with cervical spinal cord injury (CSCI', 'persons with CSCI']","['8-week stationary arm-crank exercise (ACE) training program', 'stationary ACE training', 'ACE', 'exercise training']","['maximum voluntary ventilation (MVV) and low frequency HRV (LF', 'QIF and Ppeak', 'Quadriplegia Index of Function (QIF), arm-crank peak power output (Ppeak), spirometric variables, and HRV indices', 'level of autonomy (QIF', 'exercise capacity, cardiac autonomic regulation and respiratory muscle endurance', 'level of autonomy, exercise performance, pulmonary functional parameters and resting heart rate variability (HRV']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0451400', 'cui_str': 'Quadriplegia index of function (assessment scale)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}]",,0.0228095,"ACE training increased Ppeak in both groups (p<0.05), whereas maximum voluntary ventilation (MVV) and low frequency HRV (LF) improved only in the lower CSCI group (p<0.05).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Brizuela', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Physical Activity and Sport Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sinz', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Physical Activity and Sport Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aranda', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Physical Activity and Sport Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Martínez-Navarro', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Physical Activity and Sport Sciences, University of Valencia, Valencia, Spain.'}]",European journal of sport science,['10.1080/17461391.2019.1674927']
828,31850853,Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health).,"BACKGROUND


Low-income older adults experience disparities in oral health problems, including caries and periodontal disease, that can exacerbate already high levels of chronic and acute health problems. Behavioral interventions have been shown to improve oral health status but are typically administered in institutional rather than community settings. Furthermore, multiple simultaneous interventions at different levels in the locations where people live and work are likely to have more impact and sustainability than single interventions in clinical settings.
OBJECTIVE


This paper outlines a protocol for conducting a bilingual 5-year community-based trial of a bilevel intervention that addresses community norms, beliefs, intentions, and practices to improve oral health hygiene of vulnerable older adults living in publicly subsidized housing. The intervention utilizes (1) a face-to-face counseling approach (adapted motivational interviewing [AMI]) and (2) resident-run oral health campaigns in study buildings.
METHODS


The study's modified fractional factorial crossover design randomizes 6 matched buildings into 2 conditions: AMI followed by campaign (AB) and campaign followed by AMI (BA). The total intervention cycle is approximately 18 months in duration. The design compares the 2 interventions alone (T0-T1), and in different sequences (T1-T2), using a self-reported survey and clinical assessment to measure Plaque Score (PS) and Gingival Index (GI) as outcomes. A final timepoint (T3), 6 months post T2, assesses sustainability of each sequence. The intervention is based on the Fishbein integrated model that includes both individual and contextual modifiers, norms and social influence, beliefs, attitudes, efficacy, and intention as predictors of improvements in PS, GI, and oral health quality of life. The cognitive and behavioral domains in the intervention constitute the mechanisms through which the intervention should have a positive effect. They are tailored through the AMI and targeted to building populations through the peer-facilitated oral health campaigns. The sample size is 360, 180 in each condition, with an attrition rate of 25%. The study is funded by National Institute of Dental and Craniofacial Research (NIDCR) and has been reviewed by University of Connecticut and NIDCR institutional review boards and NIDCR's clinical trials review procedures.
RESULTS


When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators. When sequences are compared, the results may be similar but affected by different mediators. The arm consisting of the BA is expected to have better sustainability. The protocol's unique features include the comparative effectiveness crossover design; the introduction of new emotion-based mediators; the balancing of fidelity, tailoring, and targeting; and resident engagement in the intervention.
CONCLUSIONS


If successful, the evaluated interventions can be scaled up for implementation in other low-income congregate living and recreational settings with older adult collectives.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02419144; https://clinicaltrials.gov/ct2/show/NCT02419144.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/14555.",2019,"When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators.","['Older Adults and People With Disabilities', 'vulnerable older adults living in publicly subsidized housing']","['intervention utilizes (1) a face-to-face counseling approach (adapted motivational interviewing [AMI]) and (2) resident-run oral health campaigns', 'campaign (AB) and campaign followed by AMI (BA', 'Behavioral interventions']","['Plaque Score (PS) and Gingival Index (GI', 'total intervention cycle', 'oral health status', 'PS, GI, and oral health quality of life']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C3714364', 'cui_str': 'Counseling approach'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0029162'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}]",,0.0540097,"When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Schensul', 'Affiliation': 'Institute for Community Research, Hartford, CT, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reisine', 'Affiliation': 'University of Connecticut School of Dental Medicine, Farmington, CT, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grady', 'Affiliation': 'Department of Public Health Sciences, University of Connecticut School of Medicine, Farmington, CT, United States.'}, {'ForeName': 'Jianghong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute for Community Research, Hartford, CT, United States.'}]",JMIR research protocols,['10.2196/14555']
829,30671682,"A Preliminary Randomized Controlled Trial of Game Plan, A Web Application to Help Men Who Have Sex with Men Reduce Their HIV Risk and Alcohol Use.","Alcohol use is a key risk factor for HIV infection among men who have sex with men (MSM). Past studies show that brief motivational interventions (BMI) can increase the use of prevention methods (e.g., condoms), reduce alcohol use, and can be adapted for web-based delivery. However, few studies have explored these interventions' effects in MSM. Forty high-risk, heavy drinking MSM who sought rapid HIV testing were randomly assigned to receive either (1) standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP), a tablet tablet-based BMI for alcohol use and HIV risk. Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls. GP participants also reported fewer high-risk condomless anal sex events than controls, but these differences were not significant. These initial results suggest that web-based BMIs may be promising tools to help MSM reduce health risk behaviors.",2019,"Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls.","['Forty high-risk, heavy drinking MSM who sought rapid HIV testing', 'men who have sex with men (MSM', 'Help Men']","['brief motivational interventions (BMI', 'standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP']","['new anal sex partners', 'high-risk condomless anal sex events', 'heavy drinking days']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",40.0,0.0311022,"Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls.","[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Wray', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. tyler_wray@brown.edu.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Simpanen', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Center for Alcohol and Addictions Studies, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02396-w']
830,31591703,Botulinum toxin type A in the treatment of lower limb spasticity in children with cerebral palsy.,"BACKGROUND


Cerebral palsy (CP) is the most common cause of physical disabilities in children in high-income countries. Spasticity is the most common motor disturbance in CP. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal spasticity in people with CP.
OBJECTIVES


To evaluate the effectiveness and safety of BoNT-A compared to other treatments used in the management of lower limb spasticity in children with CP.
SEARCH METHODS


We searched CENTRAL, PubMed, four other databases, and two trial registers in October 2018. We also searched the reference lists of relevant studies and reviews and contacted experts in the field. We did not apply any date or language restrictions.
SELECTION CRITERIA


Randomised controlled trials of children with CP, aged between birth and 19 years, treated with BoNT-A injections in the lower limb muscles compared to other interventions. The primary outcomes were gait analysis and function. The secondary outcomes were joint range of motion, quality of life, satisfaction, spasticity, and adverse events.
DATA COLLECTION AND ANALYSIS


Two review authors independently selected studies, extracted data, assessed risk of bias, and rated the quality of the evidence using GRADE. A third review author arbitrated in case of disagreements. We conducted meta-analyses of available data whenever possible, analysing dichotomous data with risk ratios (RR), and continuous data with mean differences (MD) or standardised mean differences (SMD), with 95% confidence intervals (CI). We considered a 5% significance level for all analyses.Whenever possible, we analysed outcomes at the time points at which they were assessed: short term (2 to 8 weeks); medium term (12 to 16 weeks); and long term (> 24 weeks).
MAIN RESULTS


We included 31 randomised controlled trials assessing 1508 participants. Most studies included ambulatory patients with more than one motor type of CP, and with a mean age of between three and seven years. There was a slight predominance of males.Studies compared BoNT-A in the lower limb muscles to usual care or physiotherapy (14 studies), placebo or sham (12 studies), serial casting (4 studies), or orthoses (1 study).We rated studies as at high or unclear risk of bias mainly due to random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment.BoNT-A versus usual care or physiotherapyBoNT-A might improve overall gait scores at medium-term follow-up (MD 2.80, 95% CI 1.55 to 4.05; 1 study, 40 children; very low-quality evidence) and is moderately effective at improving function at short-term (SMD 0.59, 95% CI 0.23 to 0.95; 2 studies, 123 children) and medium-term (SMD 1.04, 95% CI 0.16 to 1.91; 4 studies, 191 children) follow-up (all very low-quality evidence).BoNT-A improves ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (very low-quality evidence).The proportion of adverse events in the BoNT-A group was 0.37 (95% CI 0.08 to 0.66; I 2  = 95%; very low-quality evidence). No adverse events were reported in the control group.BoNT-A versus placebo or shamBoNT-A improves overall gait scores at short-term (RR 1.66, 95% CI 1.16 to 2.37, P = 0.006; 4 studies, 261 assessments) and medium-term (RR 1.90, 95% CI 1.32 to 2.74, P < 0.001; 3 studies, 248 assessments) follow-up, and may improve peak ankle dorsiflexion in stance (MD 15.90 degrees, 95% CI 4.87 to 26.93, P = 0.005; 1 study, 19 children) and in swing (MD 10.20 degrees, 95% CI 4.01 to 16.39, P = 0.001; 1 study, 19 children) at short-term follow-up (all moderate-quality evidence).BoNT-A is not more effective than placebo or sham at improving function at short-term (SMD 0.24, 95% CI -0.35 to 0.83, P = 0.42; 4 studies, 305 children) or long-term (SMD -0.07, 95% CI -0.48 to 0.35, P = 0.76; 2 studies, 91 children) follow-up, but has a small positive effect at medium-term follow-up (SMD 0.28, 95% CI 0.06 to 0.49, P = 0.01; 5 studies, 327 children) (all moderate-quality evidence).BoNT-A improves passive ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (moderate-quality evidence).There was no difference between groups in the rate of adverse events at short-term follow-up (RR 1.29, 95% CI 0.87 to 1.93, P = 0.21; 12 studies, 918 children; moderate-quality evidence).BoNT-A versus serial castingThere was no difference between groups for overall gait scores at short-term (MD 0.00, 95% CI -1.66 to 1.66); medium-term (MD 0.65, 95% CI -1.21 to 2.51); or long-term (MD 0.46, 95% CI -1.33 to 2.25) follow-up in one study with 18 children (moderate-quality evidence).BoNT-A improved instrumented gait analysis only in terms of ankle dorsiflexion at initial contact (MD 6.59 degrees, 95% CI 1.39 to 11.78, P = 0.01; 2 studies, 47 children). There was no difference between groups for peak ankle dorsiflexion in stance and swing, and gait speed at any time point (moderate- and low-quality evidence).BoNT-A is not more effective than serial casting at improving function, ankle range of motion, and spasticity at any time point (moderate- and low-quality evidence).BoNT-A is not associated with a higher risk of adverse events than serial casting (RR 0.59, 95% CI 0.03 to 11.03; 3 studies, 64 children; low-quality evidence).BoNT-A versus orthosesThere was no difference between groups for function at medium-term follow-up (MD 11.14, 95% CI -0.05 to 22.33; 1 study, 43 children), but BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity (all very low-quality evidence).
AUTHORS' CONCLUSIONS


The quality of the evidence was low or very low for most of the outcomes analysed. We found limited evidence that BoNT-A is more effective than placebo or a non-placebo control at improving gait, joint range of motion, satisfaction, and lower limb spasticity in children with CP, whereas the results for function were contradictory. The rate of adverse events with BoNT-A is similar to placebo. BoNT-A is not more effective than ankle serial casting to treat ankle contractures for any of the assessed outcomes, but is more effective than orthotics at improving range of motion and spasticity.",2019,"BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity (all very low-quality evidence).
","['people with CP', 'children with CP', 'children with CP, aged between birth and 19 years', 'children in high-income countries', 'children with cerebral palsy', 'ambulatory patients with more than one motor type of CP, and with a mean age of between three and seven years', '1508 participants']","['Botulinum toxin type A', 'placebo', 'Botulinum toxin type A (BoNT-A']","['joint range of motion, quality of life, satisfaction, spasticity, and adverse events', 'peak ankle dorsiflexion in stance and swing, and gait speed', 'gait, joint range of motion, satisfaction, and lower limb spasticity', 'gait analysis and function', 'adverse events', 'passive ankle range of motion, satisfaction, and ankle plantarflexors spasticity', 'peak ankle dorsiflexion in stance', 'overall gait scores', 'ankle range of motion, satisfaction, and ankle plantarflexors spasticity', 'function, ankle range of motion, and spasticity at any time point (moderate- and low-quality evidence).BoNT', 'rate of adverse events', 'hip range of motion and hip adductors spasticity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}]","[{'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0576002', 'cui_str': 'Joint movement: hip'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",918.0,0.369071,"BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity (all very low-quality evidence).
","[{'ForeName': 'Francesco C', 'Initials': 'FC', 'LastName': 'Blumetti', 'Affiliation': 'Department of Orthopaedics and Traumatology, Universidade Federal de São Paulo, Rua Borges Lagoa, 783 - 5º andar, São Paulo, São Paulo, Brazil, 04038-032.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Belloti', 'Affiliation': ''}, {'ForeName': 'Marcel Js', 'Initials': 'MJ', 'LastName': 'Tamaoki', 'Affiliation': ''}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Pinto', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001408.pub2']
831,28853107,A Comparative Study on the Clinical Efficacy of Two Different Disposable Circumcision Suture Devices in Adult Males.,"PURPOSE


We evaluated the safety and efficacy of two different kinds of disposable circumcision suture devices in adult men.
MATERIALS AND METHODS


Adult male patients (n = 179; mean age: 23.7 years) with redundant prepuce and/or phimosis were included in a clinical trial from July 2015 to August 2016. Patients were divided into 2 groups: group A using the Langhe disposable circumcision suture device (n = 89), and group B using the Daming disposable circumcision suture device (n = 94).
RESULTS


Intraoperative and postoperative bleeding were more serious in the group A of disposable circumcision suture device compared with the group B of disposable circumcision suture device (4.21 ± 1.31 ml) versus (2.56 ± 1.45 ml). Patients in the group B of disposable circumcision suture device had a longer swelling time (group A versus group B: 11.7 ± 0.9 days versus 14.5 ± 1.4 days), the postoperative pain score in the 7 days after surgery (group A versus group B: 2.9 ± 0.9 versus 3.8 ± 1.5), and higher postoperative infection rate (group A versus group B: 4.7% versus 13.8%), the differences were statistically significant (p < 0.05).
CONCLUSION


postoperative complications of the two kinds of disposable circumcision suture devices are different. We should pay attention to the risk of postoperative bleeding when the patients use the Langhe disposable circumcision suture device, while the patients who use the Langhe disposable circumcision suture device will have a longer healing time, and postoperative pain and the risk of infection cannot be ignored after the surgery.",2017,"RESULTS


Intraoperative and postoperative bleeding were more serious in the group A of disposable circumcision suture device compared with the group B of disposable circumcision suture device (4.21 ± 1.31 ml) versus (2.56 ± 1.45 ml).","['Adult Males', 'and/or phimosis were included in a clinical trial from July 2015 to August 2016', 'Adult male patients (n = 179; mean age: 23.7 years) with redundant prepuce', 'adult men']","['disposable circumcision suture devices', 'disposable circumcision suture device', 'Daming disposable circumcision suture device', 'Two Different Disposable Circumcision Suture Devices', 'Langhe disposable circumcision suture device']","['longer swelling time', 'safety and efficacy', 'postoperative infection rate', 'postoperative pain score', 'Intraoperative and postoperative bleeding']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0031538', 'cui_str': 'Phimosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0345325', 'cui_str': 'Redundant prepuce (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0403327', 'cui_str': 'Ritual circumcision (procedure)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}]",,0.0253598,"RESULTS


Intraoperative and postoperative bleeding were more serious in the group A of disposable circumcision suture device compared with the group B of disposable circumcision suture device (4.21 ± 1.31 ml) versus (2.56 ± 1.45 ml).","[{'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China. wind-301@163.com.""}, {'ForeName': 'Jihan', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Departments of anesthesiology, the first people's hospital of Huzhou, Zhejiang province, China.""}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}, {'ForeName': 'Jianer', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}, {'ForeName': 'Weigao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}, {'ForeName': 'Rongjiang', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China.""}]",Urology journal,[]
832,32412181,Live lectures and videos do not differ in relation to learning outcomes of dental ergonomics.,"OBJECTIVES


This study aimed to compare the knowledge attained by third-year dental students in physical ergonomics altering live lectures and videos in teaching. The second aim was to investigate implementation of the theoretical knowledge on ergonomics into practice.
MATERIAL AND METHODS


Forty-five students divided into two groups attended a live lecture (45 min) or viewed videos (45 min). After the first teaching session, the groups changed parts. All students answered a questionnaire with 13 true or false-questions on ergonomics at baseline and immediately after both teaching sessions. Friedman's test and Wilcoxon signed rank test were used to compare questionnaire scores of the student groups. Additionally, we photographed 17 randomly selected students 3 months after baseline during a simulation workshop on endodontics. We analyzed the photographs for ergonomic postures using a specific 12-point checklist.
RESULTS


At baseline, no difference in the knowledge between the two groups was discovered, when both scored 72%. After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group). After the second teaching session, the scores were similar in both groups. Overall all improvement in both groups was significant (p < .001). The photograph analysis showed half of the postures being in accord with the ergonomic guidelines.
CONCLUSIONS


Both live lectures and videos showed similar outcomes in teaching ergonomics. Implementation of the knowledge on ergonomics is insufficient. Videos provide an easy-to-organize alternative to live lectures in teaching dental ergonomics. New means are needed to have dental students implement their knowledge on ergonomics into practice.",2020,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","['Forty-five students divided into two groups attended a', 'third-year dental students in physical ergonomics altering live lectures and videos in teaching']",['live lecture (45\u2009min) or viewed videos'],['questionnaire scores'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4505395', 'cui_str': 'Physical Ergonomics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0185547,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Leinonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Laitala', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pirttilahti', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Niskanen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pesonen', 'Affiliation': 'Infrastructure for Population Studies, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Anttonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.300']
833,28670677,A Randomized Control Trial Comparing Combined Glandular Lidocaine Injection and Intraurethral Lidocaine Gel with Intraurethral Lidocaine Gel Alone in Cystoscopy and Urethral Dilatation.,"PURPOSE


Cystoscopy is one of the most common urologic procedures. The aim of this study is to investigate the combined effect of intraurethral lidocaine gel and intraglandular injection of lidocaine 2% on pain during and after cystoscopy. Materials &amp; Methods: In this double-blind, parallel group randomized clinical trial, 156 patients referred for double J removal, urethral dilatation, or cystoscopy were enrolled. The patients were divided into two groups, A and B. All patients received 20 cc of intraurethral lidocaine gel 2%. In group A (N = 75), lidocaine 2% was also injected into the glans penis. The patients in group B (N = 81) only received the intraurethral lidocaine gel. Cystoscopy was performed 10 minutes later. The primary outcome of interest was measured in terms of pain score (visual analogue scale) during and 5 minutes after cystoscopy.
RESULTS


Immediate pain score after the procedure was 3.4 &plusmn; 3 and 4.6 &plusmn; 3 in groups A and B, respectively (P = .011).
CONCLUSION


Based on the findings of the present study, lidocaine injection into the glans penis significantly reducedpain perception.",2017,"RESULTS


Immediate pain score after the procedure was 3.4 &plusmn; 3 and 4.6 &plusmn; 3 in groups A and B, respectively (P = .011).
","['pain during and after cystoscopy', 'Cystoscopy and Urethral Dilatation', '156 patients referred for double J removal, urethral dilatation, or cystoscopy were enrolled']","['lidocaine', 'intraurethral lidocaine gel and intraglandular injection of lidocaine', 'intraurethral lidocaine gel', 'Combined Glandular Lidocaine Injection and Intraurethral Lidocaine Gel with Intraurethral Lidocaine Gel Alone']","['pain score (visual analogue scale', 'Immediate pain score']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C1457917', 'cui_str': 'Urethral dilatation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0225353', 'cui_str': 'Glandular (qualifier value)'}, {'cui': 'C4081145', 'cui_str': 'Lidocaine Injection [Xylocaine]'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",156.0,0.0880202,"RESULTS


Immediate pain score after the procedure was 3.4 &plusmn; 3 and 4.6 &plusmn; 3 in groups A and B, respectively (P = .011).
","[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Gooran', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Pourfakhr', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bahrami', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran.'}, {'ForeName': 'Ali Mohammad', 'Initials': 'AM', 'LastName': 'Fakhr Yasseri', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran. yasseri_2006@yahoo.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Javid', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Behtash', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Pourmand', 'Affiliation': 'Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Hassan-Abad Sq., Tehran, Iran.'}]",Urology journal,[]
834,31808594,Ivermectin for causal malaria prophylaxis: a randomised controlled human infection trial.,"OBJECTIVE


Ivermectin is safe and widely used for treating helminth infections. It also kills arthropods feeding on treated subjects, including malaria vectors. Thus, ivermectin mass drug administration as an additional tool for malaria control is being evaluated by WHO. As in vitro data, animal experiments and epidemiological observations suggest that ivermectin has a direct effect on the liver stages of the malaria parasite, this study was designed to assess the prophylactic effect of ivermectin on Plasmodium falciparum controlled human malaria infection.
METHODS


A total of 4 volunteers were randomised to placebo, and 8 volunteers were randomised to receive ivermectin 0.4 mg/kg, orally, once 2 h before being experimentally infected intravenously with 3200 P. falciparum sporozoites. The primary endpoint was time to parasitaemia detected by positive thick blood smear; RT-qPCR was performed in parallel.
RESULTS


All but one volunteer became thick blood smear positive between day 11 and day 12 after infection, and there was no significant effect of ivermectin on parasitaemia.
CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.",2020,"CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.",['A total of 4 volunteers'],"['placebo', 'ivermectin', 'Ivermectin']","['parasitaemia', 'time to parasitaemia detected by positive thick blood smear; RT-qPCR', 'thick blood smear positive']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.120553,"CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.","[{'ForeName': 'Wolfram G', 'Initials': 'WG', 'LastName': 'Metzger', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Theurer', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pfleiderer', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Molnar', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Maihöfer-Braatting', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Alfred L', 'Initials': 'AL', 'LastName': 'Bissinger', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Zita', 'Initials': 'Z', 'LastName': 'Sulyok', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Köhler', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Egger-Adam', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lalremruata', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Lee Sim', 'Affiliation': 'Sanaria Inc., Rockville, MD, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc., Rockville, MD, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Rabinovich', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chaccour', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Alonso', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Mordmüller', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13357']
835,31567041,Effect of cash incentives on tetanus toxoid vaccination among rural Nigerian women: a randomized controlled trial.,"Tetanus toxoid vaccination is freely available for most women in developing countries, yet maternal and neonatal tetanus are still prevalent in 13 countries, 9 of which are in sub-Saharan Africa. We evaluated whether providing cash incentives increases the uptake of tetanus toxoid vaccination among women of childbearing age in rural northern Nigeria. We randomized amounts of cash incentives to women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar). Overall, of 2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800). Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5. We further found that transportation costs are one of the significant barriers that prevent women from receiving vaccination at clinics, and that cash incentives compensate for transportation costs unless such costs are large.",2020,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"['women of childbearing age in rural northern Nigeria', 'women in three groups: 5 Nigerian naira (C5), 300 naira (C300), and 800 naira (C800) (150 naira = 1 U.S. dollar', 'rural Nigerian women', '2,482 women from 80 villages, 1,803 (72.6%) women successfully received the vaccination (419 of 765 [54.8%] women in C5, 643 of 850 [75.7%] women in C300, and 741 of 867 [85.5%] women in C800']","['cash incentives', 'vaccine', 'Tetanus toxoid vaccination']","['uptake of tetanus toxoid vaccination', 'tetanus toxoid vaccination']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",2482.0,0.0926217,Women in C300 and C800 were significantly more likely to receive the vaccine than women in C5.,"[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Harvard T.H.Chan School of Public Health, Global Health and Population, Boston, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Fintan', 'Affiliation': 'Adamawa Satate Primary Healthcare Development Agency, Nigeria.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1672493']
836,31518721,Impact of the type of electroanatomic mapping system on the incidence of cerebral embolism after radiofrequency catheter ablation of left atrial tachycardias.,"BACKGROUND


Left atrial tachycardias (ATs) often occur after left atrial ablation. The incidence of symptomatic and silent cerebral embolism after radiofrequency catheter ablation of left ATs and the impact of the type of 3-dimensional electroanatomic mapping (3D-EAM) system on the incidence of cerebral embolism remain unclear.
OBJECTIVES


This study aimed to investigate the incidence of cerebral embolism after a 3D-EAM system-guided left AT ablation procedure and compare that between the different 3D-EAM systems.
METHODS


We prospectively enrolled 59 patients who underwent left AT ablation and brain magnetic resonance imaging after the procedure: 30 were guided by the Rhythmia system (Boston Scientific, Marlborough, MA) and 29 by the CARTO system (Biosense Webster, Diamond Bar, CA) (groups R and C, respectively).
RESULTS


One transient ischemic attack occurred in group R, and no symptomatic embolism occurred in group C. Silent cerebral ischemic lesions (SCILs) were observed in 35 patients (59.3%), and group R had a significantly higher incidence of SCILs than did group C (86.2% vs 33.3%; P < .001). In multivariate analysis, group R and left atrial linear ablation were independent positive predictors of SCILs (odds ratio 12.822 and 8.668; P = .001 and P = .005). The incidence of bleeding complications was comparable between groups R and C (0% vs 3.3%; P = .508).
CONCLUSION


Group R exhibited a higher incidence of postablation cerebral embolism than did group C. The use of the high-resolution 3D-EAM system with a mini-basket catheter to guide radiofrequency ablation of left atrial macroreentrant tachycardias may markedly increase the risk of silent cerebral embolism. The present results require further validation in a randomized study.",2020,The use of the high resolution 3D-EAM system with a mini-basket catheter to guide radiofrequency ablation of left atrial macroreentrant tachycardias may markedly increase the risk of silent cerebral embolism.,"['cerebral embolism after radiofrequency catheter ablation of left atrial tachycardias', '59 patients who underwent a left AT ablation and brain magnetic resonance imaging after the procedure: 30 were guided by the Rhythmia™ system and 29 by the CARTO® system']","['3-dimesional electroanatomic mapping (3D-EAM) system', '3D-EAM system-guided left AT ablation', 'electroanatomic mapping system']","['symptomatic embolism', 'cerebral ischemic lesions (SCILs', 'incidence of SCILs', 'transient ischemic attack', 'risk of silent cerebral embolism', 'incidence of post-ablation cerebral embolism', 'incidence of symptomatic and silent cerebral embolism', 'incidence of bleeding complications']","[{'cui': 'C0007780', 'cui_str': 'Cerebral Embolism'}, {'cui': 'C0162561', 'cui_str': 'Catheter Ablation, Radiofrequency'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0007780', 'cui_str': 'Cerebral Embolism'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",59.0,0.052907,The use of the high resolution 3D-EAM system with a mini-basket catheter to guide radiofrequency ablation of left atrial macroreentrant tachycardias may markedly increase the risk of silent cerebral embolism.,"[{'ForeName': 'Kohki', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan. Electronic address: kohkinakamura@yahoo.co.jp.'}, {'ForeName': 'Takehito', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Take', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Mitsuho', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Kishi', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Okazaki', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Motoda', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Katsura', 'Initials': 'K', 'LastName': 'Niijima', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Miki', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koyama', 'Affiliation': 'Division of Radiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Nobusada', 'Initials': 'N', 'LastName': 'Funabashi', 'Affiliation': 'Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, Chuo-ku, Chiba City, Chiba, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi City, Gunma, Japan.'}]",Heart rhythm,['10.1016/j.hrthm.2019.09.009']
837,28623849,"Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.","Lambert-Eaton myasthenia (LEM) is a rare autoimmune disorder associated with debilitating muscle weakness. There are limited treatment options and 3,4-diaminopyridine (3,4-DAP) free base is an investigational orphan drug used to treat LEM-related weakness. We performed a population pharmacokinetic/pharmacodynamic (PK/PD) analysis using 3,4-DAP and metabolite concentrations collected from a phase II study in patients with LEM. The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure. A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis. A two-compartment and one-compartment model for parent and metabolite, respectively, described the PK data well. Body weight and serum creatinine partially explained the variability in clearance for the final PK model. A fractional inhibitory maximum effect (E max  ) model characterized the exposure-response relationship well. The PK/PD model was applied to identify a suggested dosing approach for 3,4-DAP free base.",2017,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","['Patients With Lambert-Eaton Myasthenia', 'patients with LEM', 'A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis']","['Lambert-Eaton myasthenia (LEM', '3,4-Diaminopyridine', '3,4-diaminopyridine']",['Body weight and serum creatinine'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0046948', 'cui_str': '3,4-Pyridinediamine'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",32.0,0.049487,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Thakkar', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Aleš', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peloquin', 'Affiliation': 'College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12218']
838,31505986,Adaptive clinical endpoint bioequivalence studies with sample size re-estimation based on a nuisance parameter.,"A clinical endpoint bioequivalence (BE) study is often used to establish bioequivalence (BE) between a locally acting generic drug (T) and an innovator drug (R), which is a double-blind, randomized three-arm (T, R and placebo: P) parallel clinical trial. BE is established if two superiority tests (T vs. P, R vs. P) and one equivalence test (T vs. R) all pass. An accurate estimate of the nuisance parameter (e.g. variance) is vital in determining an accurate sample size to attain sufficient power. However, due to potential study design variations between NDA and Abbreviated NDA (ANDA) studies and high variability of clinical endpoints, variance may be over- or under-estimated, resulting in unnecessary extra costs or underpowered studies. Traditionally, clinical endpoint BE studies use a fixed study design. In this work, we propose four sample size re-estimation approaches based on a nuisance parameter and recommend one approach after comparing various operating characteristics by simulation. The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.",2019,"The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.232121,"The proposed adaptive design with sample size re-estimation provides a more accurate estimate of sample size without wasting resources or under-powering the study and controls the Type 1 error rate under a negligible level, both for the family-wise alpha and individual alpha for superiority and equivalence tests.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Louisiana State University Health Sciences Center , New Orleans , LA , USA.'}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'OB/DBVIII, FDA/CDER , Silver Spring , MD , USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1657143']
839,27928809,Efficacy of Medical Expulsive Therapy in Renal Calculi Less than or Equal to 5 Millimetres in Size.,"PURPOSE


Natural history and modality of treatment for asymptomatic renal calculi less than or equal to 5 millimetres in size is still unknown. Many options are available ranging from medical expulsive therapy to minimally invasive surgery. Till date no study has focussed on this very common but asymptomatic issue. Hence, this study is undertaken to evaluate efficacy of medical expulsive therapy in renal calculi less than or equal to 5mm in size.
MATERIALS AND METHODS


A prospective, parallel group, randomized study was carried out from 1st June 2014 to 31st May 2015, with total of 100 patients, 50 patients in each group. Patients with renal stones less than or equal to 5mm were included in the study. Group A Patients were administered medical expulsive therapy which included  tamsulosin 0.4 mg daily at night time, furosemide 20mg, spironolactone 50mg in a single morning dose, and syrup potassium magnesium citrate 20Meq per dose three times a day for 12 weeks while group B patients were given placebo. The primary outcome variable was number of patients achieving clearance of stone during 12-week treatment period in both groups.
RESULTS


No statistically significant differences in age, gender, stone size, and calyceal stone location was found between the two treatment arms. A spontaneous stone expulsion rate of 50% (at 6 weeks) and 86 %( at 12 weeks) was noted in group A versus 28% (at 6 weeks) and 38 % (at 12 weeks) in group B. Less number of pain episodes and less analgesic medication was required in group A as compared to group B.
CONCLUSION


Medical Expulsive therapy for 12 weeks significantly improves stone free rates in renal calyceal calculi less than or equal to 5mm.",2016,Medical Expulsive therapy for 12 weeks significantly improves stone free rates in renal calyceal calculi less than or equal to 5mm.,"['Renal Calculi Less than or Equal to 5 Millimetres in Size', 'Patients with renal stones less than or equal to 5mm were included in the study', '1st June 2014 to 31st May 2015, with total of 100 patients, 50 patients in each group', 'renal calculi less than or equal to 5mm in size']","['medical expulsive therapy which included \xa0tamsulosin 0.4 mg daily at night time, furosemide 20mg, spironolactone 50mg in a single morning dose, and syrup potassium magnesium citrate 20Meq', 'Medical Expulsive Therapy', 'medical expulsive therapy', 'placebo']","['analgesic medication', 'stone free rates', 'number of pain episodes', 'spontaneous stone expulsion rate', 'number of patients achieving clearance of stone', 'age, gender, stone size, and calyceal stone location']","[{'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0986198', 'cui_str': 'Furosemide 20 MG'}, {'cui': 'C0992989', 'cui_str': 'Spironolactone 50 MG'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0458173', 'cui_str': 'Syrup (substance)'}, {'cui': 'C0084141', 'cui_str': 'potassium-magnesium citrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus (disorder)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]",100.0,0.0226357,Medical Expulsive therapy for 12 weeks significantly improves stone free rates in renal calyceal calculi less than or equal to 5mm.,"[{'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Daga', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}, {'ForeName': 'Vinayak G', 'Initials': 'VG', 'LastName': 'Wagaskar', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}, {'ForeName': 'Harshawardhan', 'Initials': 'H', 'LastName': 'Tanwar', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Shelke', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}, {'ForeName': 'Bhushan', 'Initials': 'B', 'LastName': 'Patil', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Patwardhan', 'Affiliation': ""Department of Urology, King's Edward Memorial Hospital, Mumbai, India.""}]",Urology journal,[]
840,31588801,Anterior versus posterior approach total hip arthroplasty: patient-reported and functional outcomes in the early postoperative period.,"PURPOSE


Direct anterior approach total hip arthroplasty (DA THA) has been reported to improve early outcomes compared to posterior approach THA up to 6 weeks postoperatively. Limited weekly outcomes data are available prior to 6 weeks. We evaluate outcomes including when patients first drive a car, leave home, and discontinue their assist device.
METHODS


Patients undergoing THA for primary osteoarthritis were prospectively enrolled. Outcomes data were collected preoperatively and postoperatively at weekly intervals for 6 weeks.
RESULTS


111 patients (55 DA and 56 posterior approach) were enrolled. There was no significant difference ( p >  0.05) in pre-surgical Patient-Reported Outcomes Measurement Information System (PROMIS) scores or modified Harris Hip Score (mHHS).Postoperatively, the DA THA group had decreased length of stay ( p =  0.0002) and increased distance walked on postoperative day 1 and 2 ( p =  0.011,  p =  0.0004). The DA group had lower pain scores ( p <  0.05) and required less day 1 and total narcotics ( p =  0.029,  p =  0.01). The DA cohort had improved PROMIS Physical Function scores and mHHS up to 5 weeks postoperatively. DA patients discontinued their assistive device 8 days earlier ( p =  0.01), left home 3 days earlier ( p =  0.001), and drove a car 5 days earlier ( p =  0.01).
CONCLUSIONS


Patients undergoing DA THA discontinued their assistive device, left their home, and drove a car sooner than posterior approach patients. We found improvement in physical function with DA, and it persisted up to 5 weeks postoperatively. Furthermore, DA patients had significantly shorter length of stay, improved mobilisation, decreased narcotic requirements and improved inpatient pain scores compared to posterior approach THA. Future randomised controlled study should be performed to minimise the biases inherent in this study methodology and confirm the results.",2020,There was no significant difference ( p >  0.05) in pre-surgical Patient-Reported Outcomes Measurement Information System (PROMIS) scores or modified Harris Hip Score (mHHS).,"['111 patients (55 DA and 56 posterior approach) were enrolled', 'Patients undergoing THA for primary osteoarthritis were prospectively enrolled']",['Direct anterior approach total hip arthroplasty (DA THA'],"['inpatient pain scores', 'length of stay', 'physical function', 'Outcomes Measurement Information System (PROMIS) scores or modified Harris Hip Score (mHHS', 'shorter length of stay, improved mobilisation, decreased narcotic requirements', 'PROMIS Physical Function scores', 'total narcotics', 'lower pain scores']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C1384584', 'cui_str': 'Generalized osteoarthritis (disorder)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960598', 'cui_str': 'Modified Harris hip score'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",111.0,0.0240702,There was no significant difference ( p >  0.05) in pre-surgical Patient-Reported Outcomes Measurement Information System (PROMIS) scores or modified Harris Hip Score (mHHS).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Martusiewicz', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Delagrammaticas', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Harold', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Bhatt', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Beal', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Manning', 'Affiliation': 'Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019881413']
841,28165634,Pharmacogenetics of antiepileptic drug efficacy in childhood absence epilepsy.,"OBJECTIVE


To determine whether common polymorphisms in CACNA1G, CACNA1H, CACNA1I, and ABCB1 are associated with differential short-term seizure outcome in childhood absence epilepsy (CAE).
METHODS


Four hundred forty-six CAE children in a randomized double-blind trial of ethosuximide, lamotrigine, and valproate had short-term seizure outcome determined. Associations between polymorphisms (minor allele frequency ≥ 15%) in 4 genes and seizure outcomes were assessed. In vitro electrophysiology on transfected CACNA1H channels determined impact of 1 variant on T-type calcium channel responsiveness to ethosuximide.
RESULTS


Eighty percent (357 of 446) of subjects had informative short-term seizure status (242 seizure free, 115 not seizure free). In ethosuximide subjects, 2 polymorphisms (CACNA1H rs61734410/P640L, CACNA1I rs3747178) appeared more commonly among not-seizure-free participants (p = 0.011, odds ratio [OR] = 2.63, 95% confidence limits [CL] = 1.25-5.56; p = 0.026, OR = 2.38, 95% CL = 1.11-5.00). In lamotrigine subjects, 1 ABCB1 missense polymorphism (rs2032582/S893A; p = 0.015, OR = 2.22, 95% CL = 1.16-4.17) was more common in not-seizure-free participants, and 2 CACNA1H polymorphisms (rs2753326, rs2753325) were more common in seizure-free participants (p = 0.038, OR = 0.52, 95% CL = 0.28-0.96). In valproate subjects, no common polymorphisms were associated with seizure status. In vitro electrophysiological studies showed no effect of the P640L polymorphism on channel physiology in the absence of ethosuximide. Ethosuximide's effect on rate of decay of Ca V  3.2 was significantly less for P640L channel compared to wild-type channel.
INTERPRETATION


Four T-type calcium channel variants and 1 ABCB1 transporter variant were associated with differential drug response in CAE. The in vivo P640L variant's ethosuximide effect was confirmed by in vitro electrophysiological studies. This suggests that genetic variation plays a role in differential CAE drug response. Ann Neurol 2017;81:444-453.",2017,In vitro electrophysiological studies showed no effect of the P640L polymorphism on channel physiology in the absence of ethosuximide.,"['childhood absence epilepsy', 'childhood absence epilepsy (CAE', 'Eighty percent (357 of 446) of subjects had informative short-term seizure status (242 seizure free, 115 not seizure free', 'Four hundred forty-six CAE children']","['ethosuximide, lamotrigine, and valproate', 'lamotrigine', 'valproate', 'P640L channel']",['rate of decay of Ca V'],"[{'cui': 'C4281785', 'cui_str': 'Pykno-Epilepsy'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015043', 'cui_str': 'Ethosuximide'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C1265875', 'cui_str': 'Disintegration'}]",446.0,0.434374,In vitro electrophysiological studies showed no effect of the P640L polymorphism on channel physiology in the absence of ethosuximide.,"[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ""Comprehensive Epilepsy Center, Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Holland', 'Affiliation': ""Comprehensive Epilepsy Center, Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Valerie P', 'Initials': 'VP', 'LastName': ""O'Brien"", 'Affiliation': ""Comprehensive Epilepsy Center, Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Keddache', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Martin', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Peggy O', 'Initials': 'PO', 'LastName': 'Clark', 'Affiliation': ""Comprehensive Epilepsy Center, Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Cnaan', 'Affiliation': ""Division of Biostatistics and Study Methodology, Children's National Health System, Washington, DC.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Dlugos', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Deborah G', 'Initials': 'DG', 'LastName': 'Hirtz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, MD.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Division of Neurology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Grabowski', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.24886']
842,32492138,No effect of resveratrol supplementation after 6 months on insulin sensitivity in overweight adults: a randomized trial.,"BACKGROUND


Effects of resveratrol on metabolic health have been studied in several short-term human clinical trials, with conflicting results. Next to dose, the duration of the clinical trials may explain the lack of effect in some studies, but long-term studies are still limited.
OBJECTIVES


The objective of this study was to investigate the effects of 6-mo resveratrol supplementation on metabolic health outcome parameters.
METHODS


Forty-one overweight men and women (BMI: 27-35 kg/m2; aged 40-70 y) completed the study. In this parallel-group, double-blind clinical trial, participants were randomized to receive either 150 mg/d of resveratrol (n = 20) or placebo (n = 21) for 6 mo. The primary outcome of the study was insulin sensitivity, using the Matsuda index. Secondary outcome measures were intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep. Postintervention differences between the resveratrol and placebo arms were evaluated by ANCOVA adjusting for corresponding preintervention variables.
RESULTS


Preintervention, no differences were observed between the 2 treatment arms. Insulin sensitivity was not affected after 6 mo of resveratrol treatment (adjusted mean Matsuda index: 5.18 ± 0.35 in the resveratrol arm compared with 5.50 ± 0.34 in the placebo arm), although there was a significant difference in postintervention glycated hemoglobin (HbA1c) between the arms (P = 0.007). The adjusted means showed that postintervention HbA1c was lower on resveratrol (35.8 ± 0.43 mmol/mol) compared with placebo (37.6 ± 0.44 mmol/mol). No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
CONCLUSIONS


After 6 mo of resveratrol supplementation, insulin sensitivity was unaffected in the resveratrol arm compared with the placebo arm. Nonetheless, HbA1c was lower in overweight men and women in the resveratrol arm. This trial was registered at Clinicaltrials.gov as NCT02565979.",2020,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","['overweight adults', 'Forty-one overweight men and women', 'BMI: 27-35 kg/m2; aged 40-70 y) completed the study']","['6-mo resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['insulin sensitivity, using the Matsuda index', 'metabolic health outcome parameters', 'postintervention glycated hemoglobin (HbA1c', 'postintervention HbA1c', 'insulin sensitivity', 'IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep', 'Insulin sensitivity', 'intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",41.0,0.562601,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Rodrigo Mancilla', 'Initials': 'RM', 'LastName': 'Fuentes', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Essers', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa125']
843,31570258,Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial.,"BACKGROUND


Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy.
METHODS


In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting.
FINDINGS


Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group.
INTERPRETATION


TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems.
FUNDING


Boston Scientific (USA).",2019,"The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group.
","['patients (aged ≥75 years) undergoing', 'for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK', 'older patients with symptomatic severe aortic stenosis', 'patients with symptomatic severe aortic stenosis', '5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled', 'patients undergoing TAVR']","['transfemoral TAVR', 'transcatheter aortic valve replacement', 'self-expanding versus a balloon-expandable bioprosthesis', 'Transcatheter aortic valve replacement (TAVR']","['acute kidney injury', 'moderate or severe prosthetic aortic regurgitation', 'Safety and efficacy', 'superiority of the SAPIEN 3 device over the ACURATE neo device', 'cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure', 'incidence of all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",367.0,0.350971,"The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group.
","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Lanz', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Won-Keun', 'Initials': 'WK', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiac, Thoracic and Thoracic Vascular Surgery, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Burgdorf', 'Affiliation': 'Heart and Vascular Centre, Bad Bevensen, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': 'Department of Internal Medicine I, St-Johannes-Hospital, Dortmund, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Internal Medicine and Cardiology, Heart Centre Dresden, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Redwood', 'Affiliation': ""Department of Cardiology, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thilo', 'Affiliation': 'Department of Cardiology, Klinikum Augsburg, Augsburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hilker', 'Affiliation': 'Department of Cardiothoracic Surgery, University Medical Centre, Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'German Heart Centre, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Centre Leipzig, Leipzig, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Conzelmann', 'Affiliation': 'Department of Cardiac Surgery, Helios Klinik, Karlsruhe, Germany.'}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Conradi', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Centre Hamburg, Hamburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kerber', 'Affiliation': 'Department of Cardiology, Cardiovascular Centre Bad Neustadt, Bad Neustadt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schymik', 'Affiliation': 'Department of Cardiology, Städtisches Klinikum Karlsruhe, Karslruhe, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""Department of Cardiology, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Husser', 'Affiliation': 'Department of Internal Medicine I, St-Johannes-Hospital, Dortmund, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stortecky', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland. Electronic address: thomas.pilgrim@insel.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32220-2']
844,28299762,Comparison of Success Rate in Complete Supine Versus Semi Supine Percutaneous Nephrolithotomy: (The first pilot study in randomized clinical trial).,"PURPOSE


To compare outcomes and complications of percutaneous nephrolithotomy (PCNL) in the complete supine versus semi supine position in order to select the best position.
MATERIALS AND METHODS


In this clinical trial, between July 2011 and May 2014, a total of 44 patients who presented for PCNL were prospectively enrolled and randomly divided into 2 groups [complete supine (n=22), andsemi supine (n = 22)]. The results in both positions were compared regarding the complexity and outcomes. Stonefree rate was considered as a main target of the study. However, it was the first study to focus on overlapping the vertebral density during the access.
RESULTS


The two groups were comparable in age, gender, body mass index, and preoperative glomerular filtration rate, hemoglobin and creatinine. The mean operative time was significantly shorter for complete supine versus semi supine (36.68 &plusmn; 14.12 min versus 47.50 &plusmn; 16.45 min, P = .024). At the angle of 0?, overlapping with the spine occurred in 7 patients (31.8%) in semi supine group and just in 1 patient (4.5%) in complete supine group. Also, overlapping with the edge of bed occurred in 10 cases (45.5%) of complete supine and 1 (4.5%) of semi supine; the differences were statistically significant (P = .023, P = .002, respectively). No significant difference was found between the two groups in terms of stone free rate and complications.
CONCLUSION


Although, we had to convert two cases from semi supine into the complete supine position but we have demonstrated that PCNL in both positions is safe, effective and suitable for the patients. The stone free rate was similar in both groups. But the complete supine position is associated with a significantly shorter postoperative hospital stay and operative time, which may improve ease and safety of PCNL for patients.",2017,"No significant difference was found between the two groups in terms of stone free rate and complications.
","['July 2011 and May 2014, a total of 44 patients who presented for PCNL']","['Complete Supine Versus Semi Supine Percutaneous Nephrolithotomy', 'andsemi supine', 'percutaneous nephrolithotomy (PCNL']","['stone free rate and complications', 'mean operative time', 'stone free rate', 'Stonefree rate', 'postoperative hospital stay and operative time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",44.0,0.030303,"No significant difference was found between the two groups in terms of stone free rate and complications.
","[{'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Falahatkar', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Gholamjani Moghaddam', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Esmaeili', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences. samaneh_815@yahoo.com.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Kazemnezhad', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}, {'ForeName': 'Seyed Naser', 'Initials': 'SN', 'LastName': 'Seyed Esmaeili', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Motiee', 'Affiliation': 'Urology Research Center, School of Medicine, Guilan University of Medical Sciences.'}]",Urology journal,[]
845,28299764,Bolus Injection Versus Infusion of Furosemide in Kidney Transplantation: A Randomized Clinical Trial.,"PURPOSE


Furosemide is commonly administered to increase the urinary output in patients with transplanted kidneys. This study compared the two administration routes of furosemide (bolus versus infusion) in kidney transplanted patients.
MATERIALS AND METHODS


Fifty patients who had undergone kidney transplantation in 2015 in a hospital in Tabriz, Iran, were included in this clinical trial. They were divided into two groups: bolus (120 mg stat) and infusion (4 mg/minute) groups. The primary outcome was urine onset time. Secondary outcomes were urine output volume, vital signs (blood pressure, heart rate), and electrolyte level (creatinine, blood urea nitrogen, sodium and potassium). After arterial and venous anastomoses, arterial clamp removal time and diuresis onset were recorded. Finally, theurinary output volumes of both groups were measured with regular urine bags for an hour after anastomosis. Then it was repeated each three hours for 24 hours, and eventually two and three days thereafter. Finally, all data were statistically analyzed.
RESULTS


Around 72% of the patients were men (mean age of 37.15 &plusmn; 14.67 years). Urine output was higher in bolus group but it was not statistically significant. Diuresis duration was measured after arterial declamping and its averages were 5.41 &plusmn; 3.7 minutes and 9.36 &plusmn; 7.65 minutes in bolus and infusion groups, respectively (P = .040). Furosemide bolus injection and infusion had no significant effect on creatinine, blood urea nitrogen, sodium and potassium.
CONCLUSION


Furosemide bolus injection can reduce diuresis onset time compared to furosemide infusion.",2017,"Furosemide bolus injection and infusion had no significant effect on creatinine, blood urea nitrogen, sodium and potassium.
","['patients with transplanted kidneys', 'Fifty patients who had undergone kidney transplantation in 2015 in a hospital in Tabriz, Iran, were included in this clinical trial', 'kidney transplanted patients', 'Kidney Transplantation']","['Furosemide', 'furosemide']","['urine output volume, vital signs (blood pressure, heart rate), and electrolyte level (creatinine, blood urea nitrogen, sodium and potassium', 'Diuresis duration', 'urinary output', 'creatinine, blood urea nitrogen, sodium and potassium', 'urine onset time', 'arterial clamp removal time and diuresis onset', 'diuresis onset time', 'Urine output']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428284', 'cui_str': 'Finding of electrolyte levels (finding)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0232856', 'cui_str': 'Urinary output'}, {'cui': 'C0042037'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",50.0,0.334448,"Furosemide bolus injection and infusion had no significant effect on creatinine, blood urea nitrogen, sodium and potassium.
","[{'ForeName': 'Afshar', 'Initials': 'A', 'LastName': 'Zomorrodi', 'Affiliation': 'Department of Urology, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mohammadipoor Anvari', 'Affiliation': 'Department of Anesthesiology, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Kakaei', 'Affiliation': 'Department of Surgery, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Solymanzadeh', 'Affiliation': 'Department of Urology, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Khanlari', 'Affiliation': 'Department of Urology, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Department of Urology, Emam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Urology journal,[]
846,31578925,Neurodynamic sliders promote flexibility in tight hamstring syndrome.,"ABSTRACT  Hamstring injury prevention puts emphasis on optimizing the muscle's strength-length relationship. To assure appropriate muscle length, flexibility training is imperative. As neurodynamics play an important role herein, the goal of this study was to explore the intervention effect of home-based neurodynamic slider program on hamstring flexibility. Fifty physically active male subjects were randomly assigned to either performing a neurodynamic sliding technique (3 × 20 reps) or a static stretching protocol (3 × 30″) on a daily basis for a 6-week period. Hamstring flexibility was assessed by means of the Straight Leg Raise at baseline, immediately after the intervention and after 4 weeks follow up. There was no between group baseline difference in hamstring flexibility. The repeated measure ANOVA showed a significant interaction effect for group × time ( p  < 0.001). Independent sample  t -test showed a significantly higher increase in flexibility gain in the neurodynamic group immediately after the intervention ( p  < 0.001), as well as at 4 weeks retention analysis ( p  = 0.001) compared to the static stretch group. In conclusion, neurodynamic sliders might be more efficient than regular static stretching in affecting hamstring flexibility in the long run.",2020,The repeated measure ANOVA showed a significant interaction effect for group,"['tight hamstring syndrome', 'Fifty physically active male subjects']","['neurodynamic sliding technique (3\u2009×\u200920 reps) or a static stretching protocol', 'regular static stretching']","['Hamstring flexibility', 'hamstring flexibility', 'flexibility gain']","[{'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",50.0,0.0226803,The repeated measure ANOVA showed a significant interaction effect for group,"[{'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'de Ridder', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'De Blaiser', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Verrelst', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roeland', 'Initials': 'R', 'LastName': 'De Saer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Desmet', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Schuermans', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.'}]",European journal of sport science,['10.1080/17461391.2019.1675770']
847,31580310,Mobilization of the contralateral limb in Slump position: effects on knee extension in healthy adult subjects.,"BACKGROUND AND AIM


In the acute phase of neuropathic pain due to nerve root disorders, the neurodynamic approach proposes the mobilization of the contralateral limb to decrease the pain and increase the range of motion in the affected limb. The aim of this study was to evaluate the effect of the contralateral knee mobilization on the ipsilateral knee extension range of motion in Slump position in healthy adult subjects.
METHODS


Thirty-eight healthy subjects underwent a placebo, control and experimental manoeuvres that included a passive contralateral knee mobilization into extension. The knee, hip and cervical angles and distance between glabella and femoral condyle achieved in Slump test position were measured with an optoelectronic motion analysis system before and after each manoeuvre.
RESULTS


Experimental manoeuvre produced a statistically significant increase of the knee extension ROM when compared to the control (p=.017) and placebo (p=.007) manoeuvres. A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
CONCLUSIONS


The contralateral mobilization in Slump position increases the ipsilateral knee extension ROM. Further research is required to confirm that the knee increment ROM was due to the neural component.",2019,"A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
","['healthy adult subjects', 'Thirty-eight healthy subjects underwent a']","['contralateral knee mobilization', 'placebo', 'placebo, control and experimental manoeuvres that included a passive contralateral knee mobilization into extension']","['ipsilateral knee extension ROM', 'hip angle and distance between glabella and femoral condyle', 'knee extension ROM', 'knee, hip and cervical angles and distance between glabella and femoral condyle achieved in Slump test position']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0430748', 'cui_str': 'Slump test response'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",38.0,0.0399885,"A significant increase of the hip angle and distance between glabella and femoral condyle was detected after the experimental manoeuvres (p<.001), but not after the placebo and control manoeuvres.
","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Pellicciari', 'Affiliation': 'Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Rome, Italy;. leonardo.pellicciari@gmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Paci', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Geri', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Piscitelli', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Baccini', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i3.7236']
848,28167660,Eliglustat maintains long-term clinical stability in patients with Gaucher disease type 1 stabilized on enzyme therapy.,"In the phase 3 Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE), at 1 year, eliglustat was noninferior to imiglucerase enzyme therapy in maintaining stable platelet counts, hemoglobin concentrations, and spleen and liver volumes. After this primary analysis period, patients entered a long-term extension phase in which all received eliglustat. Duration on eliglustat ranged from 2 to 5 years, depending on timing of enrollment (which spanned 2 years), treatment group to which patients were randomized, and whether they lived in the United States when commercial eliglustat became available. Here we report long-term safety and efficacy of eliglustat for 157 patients who received eliglustat in the ENCORE trial; data are available for 46 patients who received eliglustat for 4 years. Mean hemoglobin concentration, platelet count, and spleen and liver volumes remained stable for up to 4 years. Year to year, all 4 measures remained collectively stable (composite end point relative to baseline values) in ≥85% of patients as well as individually in ≥92%. Mean bone mineral density z scores (lumbar spine and femur) remained stable and were maintained in the healthy reference range throughout. Eliglustat was well tolerated over 4 years; 4 (2.5%) patients withdrew because of adverse events that were considered related to the study drug. No new or long-term safety concerns were identified. Clinical stability assessed by composite and individual measures was maintained in adults with Gaucher disease type 1 treated with eliglustat who remained in the ENCORE trial for up to 4 years. This trial was registered at www.clinicaltrials.gov as #NCT00943111.",2017,Mean bone mineral density z scores (lumbar spine and femur) remained stable and were maintained in the healthy reference range throughout.,"['Patients With Gaucher Disease', '157 patients who received eliglustat in the ENCORE trial; data are available for 46 patients who received eliglustat for 4 years', 'adults with Gaucher disease type 1 treated with eliglustat who remained in the ENCORE trial for up to 4 years', 'patients with Gaucher disease type 1 stabilized on enzyme therapy']","['Enzyme Replacement Therapy (ENCORE', 'Eliglustat Tartrate (Genz-112638']","['Mean bone mineral density z scores (lumbar spine and femur', 'Mean hemoglobin concentration, platelet count, and spleen and liver volumes', 'hemoglobin concentrations, and spleen and liver volumes', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017205', 'cui_str': 'Gauchers Disease'}, {'cui': 'C3272698', 'cui_str': 'eliglustat'}, {'cui': 'C3464780', 'cui_str': 'Encore'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961835', 'cui_str': 'GBA Deficiency'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0596530', 'cui_str': 'Enzyme Therapy'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C3464780', 'cui_str': 'Encore'}, {'cui': 'C3272699', 'cui_str': 'eliglustat tartrate'}, {'cui': 'C1999530', 'cui_str': 'Genz-112638'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",157.0,0.0375495,Mean bone mineral density z scores (lumbar spine and femur) remained stable and were maintained in the healthy reference range throughout.,"[{'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Cox', 'Affiliation': ""Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Drelichman', 'Affiliation': 'Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Cravo', 'Affiliation': 'State Institute of Haematology ""Arthur de Siqueira Cavalcanti,"" Rio de Janeiro, Brazil.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'Thomas Andrew', 'Initials': 'TA', 'LastName': 'Burrow', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Martins', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lukina', 'Affiliation': 'National Research Center for Hematology, Moscow, Russia.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rosenbloom', 'Affiliation': 'Cedars-Sinai/Tower Hematology Oncology, Beverly Hills, CA.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Goker-Alpan', 'Affiliation': 'Lysosomal Disorders Unit, O&O Alpan, LLC, Fairfax, VA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Watman', 'Affiliation': 'Hospital Ramos Mejia, Buenos Aires, Argentina.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Pediatric Hematology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Maria Lucia', 'Initials': 'ML', 'LastName': 'Pedroso', 'Affiliation': 'Gastroenterology Department, Universidade Federal do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Sebastiaan J M', 'Initials': 'SJM', 'LastName': 'Gaemers', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA; and.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Tayag', 'Affiliation': 'Prometrika LLC, Cambridge, MA.'}, {'ForeName': 'M Judith', 'Initials': 'MJ', 'LastName': 'Peterschmitt', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA; and.'}]",Blood,['10.1182/blood-2016-12-758409']
849,27838172,Re: Robot-assisted Laparoscopic Prostatectomy (RALP) Versus Open Radical Retropubic Prostatectomy (RRP): Early Outcomes from a Randomised Controlled Phase 3 Trial.,,2017,,[],"['Re: Robot-assisted Laparoscopic Prostatectomy (RALP', 'Open Radical Retropubic Prostatectomy (RRP']",[],[],"[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194825', 'cui_str': 'Radical retropubic prostatectomy (procedure)'}]",[],,0.0829887,,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Urology Department, Monash Cancer Centre, Monash Health, Melbourne, Australia. Electronic address: mark.frydenberg@monash.edu.'}]",European urology,['10.1016/j.eururo.2016.10.032']
850,27928815,Comparing Monotherapy with Tadalafil or Tamsulosin and Their Combination Therapy in Men with Benign Prostatic Hyperplasia: A Randomized Clinical Trial.,"PURPOSE


To compare monotherapy with tadalafil or tamsulosin and their combination therapy in men with benignprostatic hyperplasia and erectile dysfunction by comparing IPSS score, prostate volume and Qmax and someother outcomes.
MATERIALS AND METHODS


This randomized, single-blind, paralleled group clinical trial was done in 2013 on patientswho had referred to our hospital in Tehran. All patients with lower urinary tract symptoms, benign prostatichyperplasia and any grade of erectile dysfunction were recruited. They were randomly divided into three groups(61 participants in each group): Group A received 20 mg/daily tadalafil; Group B received 0.4 mg/daily tamsulosin;Group C receieved a combination of 0.4 mg/daily tamsulosin and 20 mg/daily tadalafil. Primary outcomeswere prostate volume, prostate specific antigen, post-void residual volume, IPSS score, LUTS severity, Qmax,IIEF and erectile dysfunction severity and secondary outcome was complications.
RESULTS


The mean ± SD of ultrasonographic prostate volume was 61.4 ± 15.1 mL and prostate specific antigenlevel was 2.4 ± 1.9 ng/dl. Post-void residual level was significantly different before and after the treatment, exceptfor group A. Also, this group had no meaningful difference compared to the other groups in this regard (P > 0.05).There were significant differences between pre- and post-treatment international prostate symptom scores in eachgroup (P < 0.05).
CONCLUSION


Combination of tamsulosin and tadalafil can improve international prostate symptom scores, internationalindex of erectile function questionnaire scores and Qmax in patients with lower urinary tract symptoms andbenign prostatic hyperplasia to more degrees than their separate use. This combination is recommended becauseof its synergistic effects, well toleration and safety.",2016,"0.05).There were significant differences between pre- and post-treatment international prostate symptom scores in eachgroup (P < 0.05).
","['Men with Benign Prostatic Hyperplasia', 'patients with lower urinary tract symptoms andbenign prostatic hyperplasia', '2013 on patientswho had referred to our hospital in Tehran', 'All patients with lower urinary tract symptoms, benign prostatichyperplasia and any grade of erectile dysfunction were recruited', 'men with benignprostatic hyperplasia and erectile dysfunction by comparing IPSS score, prostate volume and Qmax and someother outcomes']","['tamsulosin;Group C receieved a combination of 0.4 mg/daily tamsulosin and 20 mg/daily tadalafil', '20 mg/daily tadalafil', 'tamsulosin and tadalafil', 'Tadalafil or Tamsulosin and Their Combination Therapy', 'tadalafil or tamsulosin and their combination therapy']","['mean ± SD of ultrasonographic prostate volume', 'Primary outcomeswere prostate volume, prostate specific antigen, post-void residual volume, IPSS score, LUTS severity, Qmax,IIEF and erectile dysfunction severity and secondary outcome was complications', 'Post-void residual level', 'international prostate symptom scores, internationalindex of erectile function questionnaire scores and Qmax']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C2937421', 'cui_str': 'Prostatic Hyperplasia'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0412489,"0.05).There were significant differences between pre- and post-treatment international prostate symptom scores in eachgroup (P < 0.05).
","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Laser application in medical sciences research center, Shohadaye Tajrish hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. karami_hosein@yahoo.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Hassanzadeh-Hadad', 'Affiliation': 'Laser application in medical sciences research center, Shohadaye Tajrish hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Fallah-Karkan', 'Affiliation': 'Laser application in medical sciences research center, Shohadaye Tajrish hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,[]
851,31524774,Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial.,"OBJECTIVE


Post-ERCP pancreatitis (PEP) is the most prevalent complication of endoscopic retrograde cholangiopancreatography (ERCP). Melatonin has been mentioned as a protective factor against acute pancreatitis. The present study was conducted to determine whether melatonin addition to indomethacin reduces the rate of PEP occurrence.
METHODS


A double-blind randomized clinical trial was conducted on 411 patients undergoing ERCP. Baseline blood samples were collected, and the patients were given melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository 100 mg, 1 h before ERCP. The occurrence of PEP was the primary outcome. The concentrations of amylase and lipase were also measured 24 h after ERCP.
RESULTS


Demographic characteristics of patients, characteristics of ERCP procedures, and baseline levels of amylase and lipase were found to be similar in both groups. The overall rate of PEP was equal to 9.5% in intention-to-treat (ITT) and 11.4% in per-protocol (PP) analyses. There was a significant difference in the rate of PEP between the melatonin and placebo groups (8.7% vs. 11.4% in ITT and 9.3% vs. 13.6% in PP, respectively). In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively).
CONCLUSION


The results of the present study showed that, administration of melatonin 3 mg tablets plus indomethacin suppository 100 mg 1 h before ERCP could decrease the PEP rate and amylase and lipase levels compared to administration of indomethacin suppository 100 mg alone.",2019,"In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively).
",['411 patients undergoing ERCP'],"['melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository', 'endoscopic retrograde cholangiopancreatography (ERCP', 'indomethacin', 'placebo', 'Melatonin', 'melatonin', 'indomethacin suppository']","['PEP rate and amylase and lipase levels', 'concentrations of amylase and lipase', 'amylase and lipase levels', 'overall rate of PEP', 'rate of PEP', 'rate of PEP occurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C1124060', 'cui_str': 'Melatonin 3 MG'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",411.0,0.672466,"In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively).
","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinazari', 'Affiliation': 'Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Asadzadeh Aghdaei', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hatami', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Rasoolinezhad', 'Affiliation': 'Department of Clinical pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Jamshidzadeh', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}, {'ForeName': 'Saeede', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001531']
852,31567637,Split dose versus full single-dose regimen of polyethylene glycol for bowel preparation in pediatric colonoscopy: a pilot study of randomized controlled trial.,"OBJECTIVES


Previous meta-analyses in adults comparing a full single dose vs. split doses of polyethylene glycol with electrolyte solution demonstrated that the split-dose group had a higher rate of successful bowel preparation. To date, no similar study in children has been conducted. Therefore, we compared the efficacy of bowel preparation between the two regimens of polyethylene glycol with electrolyte solution in pediatric colonoscopy. The secondary outcomes were tolerability, acceptability, and compliance.
METHODS


An investigator-blinded randomized controlled trial was conducted to enroll children aged 2-18 years who underwent an elective colonoscopy at a teaching hospital between March 2018 and February 2019. Patients were randomly assigned to receive polyethylene glycol with electrolyte solution as a full single dose or two split doses. The Boston Bowel Preparation Scale was used for the efficacy (i.e. successful bowel preparation if score ≥ 6). Secondary outcomes were evaluated by using a standardized questionnaire.
RESULTS


A total of 45 colonoscopies (22 in the full single-dose and 23 in the split-dose group) were performed. Mean age was 9.2 years old (SD 4.4). We noted a higher rate of successful bowel preparation in the split-dose group (95% vs. 72%, P = 0.047). Significant higher rate of willingness to repeat the same protocol (83% vs. 36%, P = 0.002) and a trend of lower rate of nausea/vomiting (39% vs. 68%, P = 0.051) in the split-dose group were found.
CONCLUSION


The split-dose regimen of polyethylene glycol with electrolyte solution for bowel preparation suggests superior efficacy, potential tolerability, and acceptability as compared to the traditional full single-dose regimen.",2019,"Significant higher rate of willingness to repeat the same protocol (83% vs. 36%, P = 0.002) and a trend of lower rate of nausea/vomiting (39% vs. 68%, P = 0.051) in the split-dose group were found.
","['pediatric colonoscopy', 'enroll children aged 2-18 years who underwent an elective colonoscopy at a teaching hospital between March 2018 and February 2019', 'Mean age was 9.2 years old (SD 4.4', 'A total of 45 colonoscopies (22 in the full single-dose and 23 in the split-dose group) were performed']","['polyethylene glycol with electrolyte solution', 'polyethylene glycol']","['superior efficacy, potential tolerability, and acceptability', 'rate of successful bowel preparation', 'nausea/vomiting', 'tolerability, acceptability, and compliance']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.238553,"Significant higher rate of willingness to repeat the same protocol (83% vs. 36%, P = 0.002) and a trend of lower rate of nausea/vomiting (39% vs. 68%, P = 0.051) in the split-dose group were found.
","[{'ForeName': 'Hansa', 'Initials': 'H', 'LastName': 'Sriphongphankul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok.'}, {'ForeName': 'Pornthep', 'Initials': 'P', 'LastName': 'Tanpowpong', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok.'}, {'ForeName': 'Chatmanee', 'Initials': 'C', 'LastName': 'Lertudomphonwanit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok.'}, {'ForeName': 'Suporn', 'Initials': 'S', 'LastName': 'Treepongkaruna', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001562']
853,27830395,Glutamine for the treatment of vincristine-induced neuropathy in children and adolescents with cancer.,"BACKGROUND


Vincristine is an integral treatment component of many childhood tumors with potentially dose-limiting sensory and/or motor neuropathy. Results from a pilot study on the incidence of vincristine-induced peripheral neuropathy (VIPN) as well as the efficacy and safety of glutamine in reducing signs and symptoms of VIPN in children with cancer are presented.
METHODS


Fifty-six patients between the ages of 5-21 with newly diagnosed leukemia, lymphoma, extracranial solid tumor or medulloblastoma and expected to receive a minimum cumulative dose of 6 mg/m 2  of vincristine over a 30-week period were eligible. Patients' neurological functioning was monitored every 3 weeks using clinical history, exam, and assessment of motor functioning. Upon identification of neuropathy, patients were randomized to either glutamine (6 g/m 2  per dose twice daily, maximum 10 g/dose) or placebo for a 3-week period followed by 3-week wash out period (Time 3).
RESULTS


Forty-nine patients were fully evaluable and 100 % developed neuropathy per study definitions. No significant differences in demographics or side effects were noted between the randomized groups. The distribution of sensory neuropathy scores between the two groups was statistically significant after the intervention (p = 0.022). Children receiving glutamine also rated their quality of life (QoL) as 8.42 points higher on the PedsQL total score than those receiving placebo (p = 0.031).
CONCLUSIONS


Glutamine supplementation is well tolerated and associated with improvements in sensory function and self-reported overall quality of life. Future studies are warranted to confirm the efficacy of glutamine for the treatment of vincristine-related sensory neuropathy in pediatric cancer patients.",2017,The distribution of sensory neuropathy scores between the two groups was statistically significant after the intervention (p = 0.022).,"['children and adolescents with cancer', 'pediatric cancer patients', 'children with cancer', 'Fifty-six patients between the ages of 5-21 with newly diagnosed leukemia, lymphoma, extracranial solid tumor or medulloblastoma and expected to receive a minimum cumulative dose of 6\xa0mg', 'Forty-nine patients were fully evaluable and 100\xa0% developed neuropathy per study definitions']","['placebo', 'vincristine', 'Glutamine', 'glutamine', 'Glutamine supplementation', 'Vincristine']","['PedsQL total score', 'demographics or side effects', 'sensory function and self-reported overall quality of life', 'quality of life (QoL', 'neurological functioning', 'distribution of sensory neuropathy scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0025149', 'cui_str': 'Medulloblastoma'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}]",56.0,0.0531603,The distribution of sensory neuropathy scores between the two groups was statistically significant after the intervention (p = 0.022).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sands', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA. sandss@mskcc.org.'}, {'ForeName': 'Elena J', 'Initials': 'EJ', 'LastName': 'Ladas', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiner', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}, {'ForeName': 'Meiko', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Organization and Leadership, Teachers College, Columbia University, 525 West 120th Street, New York, NY, 10027, USA.'}, {'ForeName': 'Deborah Hughes', 'Initials': 'DH', 'LastName': 'Ndao', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Dave', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}, {'ForeName': 'Linda T', 'Initials': 'LT', 'LastName': 'Vahdat', 'Affiliation': 'Medical Oncology, Weill Cornell Breast Center, 425 East 61st Street, New York, NY, 10065, USA.'}, {'ForeName': 'Julia Glade', 'Initials': 'JG', 'LastName': 'Bender', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Medical Center, 161 Fort Washington Avenue, New York, NY, 10032, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3441-6']
854,32413508,Antimicrobial Photodynamic Therapy with Diode laser and Methylene blue as an adjunct to scaling and root planning: A clinical trial.,"INTRODUCTION


Chronic periodontitis, the most common periodontal disease, is the destruction of tooth supporting structures and alveolar bone which may result in teeth exfoliation. Conventionally, treatment aims at decreasing bacterial load by mechanical debridement and systemic or local delivery of antibiotics. Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket. The aim of this study was to evaluate the effect of aPDT with 660 nm diode laser and methylene blue as an adjunct to scaling and root planning (SRP) on clinical periodontal parameters.
MATERIALS AND METHODS


In this clinical trial, we assessed aPDT as an adjunct to scaling and root planning (SRP) in chronic periodontitis treatment. A total of 50 subjected were enrolled. The case group received SRP and aPDT with methylene blue solution as photosensitizer and diode laser (wavelength= 660 nm, power = 150 mW) irradiation. The control group received only SRP. The effect on clinical parameters, namely Plaque index (PI), Gingival index (GI), and probing depth (PD) was recorded at baseline, 6 weeks, 3 months and 6 months.
RESULTS


There were no significant differences between participants for clinical parameters at baseline. PI, GI and PD significantly improved compared to baseline (P < 0.05).
CONCLUSION


It can be concluded that aPDT can be considered a safe and efficient technique in addition to SRP for reducing the pocket depth in chronic periodontitis patients.",2020,Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket.,"['A total of 50 subjected were enrolled', 'chronic periodontitis treatment']","['SRP', 'aPDT with 660\u2009nm diode laser and methylene blue', 'SRP and aPDT with methylene blue solution as photosensitizer and diode laser (wavelength=660\u2009nm, power\u2009=\u2009150\u2009mW) irradiation', 'aPDT', 'Antimicrobial photodynamic therapy (aPDT', 'Antimicrobial Photodynamic Therapy with Diode laser and Methylene blue', 'scaling and root planning (SRP']","['clinical parameters, namely Plaque index (PI), Gingival index (GI), and probing depth (PD', 'PI, GI and PD']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",50.0,0.0478309,Antimicrobial photodynamic therapy (aPDT) is a safe alternative adjunct therapy for elimination of pathogenic bacteria in periodontal pocket.,"[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Derikvand', 'Affiliation': 'Department of periodontics faculty of dentisty, Borujerd Branch, Islamic Azad University, Borujerd, Iran.'}, {'ForeName': 'Seyedeh Sara', 'Initials': 'SS', 'LastName': 'Ghasemi', 'Affiliation': 'Dentist, Private practice, Khorramabad, Iran.'}, {'ForeName': 'Hannaneh', 'Initials': 'H', 'LastName': 'Safiaghdam', 'Affiliation': 'Student research committee, Dental school, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Piriaei', 'Affiliation': 'Department of Mathematics, Borujerd Branch, Islamic Azad University, Borujerd, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforush', 'Affiliation': 'Dental Implant Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n-chiniforush@farabi.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101818']
855,27789136,"Relationship among physical activity, sedentary behaviors, and cardiometabolic risk factors during gastric bypass surgery-induced weight loss.","BACKGROUND


The impact of daily physical activity (PA) on the cardiometabolic risk of bariatric surgery patients is not known.
OBJECTIVE


We examined the influence of physical activity and sedentary behavior on modifying cardiometabolic risk after Roux-en-Y gastric bypass (RYGB) surgery.
SETTING


University of Pittsburgh Medical Center and East Carolina University bariatric surgery centers.
METHODS


Data from 43 women and 7 men who completed testing at 1-3 months after RYGB surgery and again at 9 months postsurgery were analyzed. Outcomes measured included PA level (min/d), steps/d, sedentary time, and body composition. Insulin sensitivity was determined with an intravenous glucose tolerance test. Weight and blood lipid profiles also were obtained.
RESULTS


Patients reduced body mass index by a mean of -8.0±3.4 kg/m 2  (P<.001), increased moderate-to-vigorous PA by 17.0±47.0 min/d (P = .014), and decreased sedentary time (-47.9±101.0 min/d, P = .002). However, 24% of patients decreased overall PA (P<.001), and 39% increased sedentary behavior (P<.001). Changes in overall PA (rho = -.33, P = .006) and steps/d (rho = -.31, P = .0106) were related to weight loss. Insulin sensitivity was associated with light PA before (rho = .37, P<.001) and after (rho = .37, P = .015) intervention. Increasing overall PA also was related to higher levels of high-density lipoprotein cholesterol (rho = .33, P<.01). Decreasing sedentary time was related to decreased fat mass (rho = .35, P = .012) but not to other cardiometabolic risk factors.
CONCLUSIONS


The majority of patients increased PA (76%) and decreased sedentary time (61%) after RYGB surgery, but the amount of PA and sedentary time varied substantially. Higher PA, even at low intensity levels, was related to beneficial outcomes in body composition, insulin sensitivity, and high-density lipoprotein cholesterol.",2017,"However, 24% of patients decreased overall PA (P<.001), and 39% increased sedentary behavior (P<.001).","['bariatric surgery patients', 'Data from 43 women and 7 men who completed testing at 1-3 months after RYGB surgery and again at 9 months postsurgery were analyzed', 'University of Pittsburgh Medical Center and East Carolina University bariatric surgery centers']","['daily physical activity (PA', 'gastric bypass surgery-induced weight loss', 'physical activity and sedentary behavior', 'Roux-en-Y gastric bypass (RYGB) surgery']","['weight loss', 'PA level (min/d), steps/d, sedentary time, and body composition', 'cardiometabolic risk', 'Weight and blood lipid profiles', 'sedentary time', 'Decreasing sedentary time', 'physical activity, sedentary behaviors, and cardiometabolic risk factors', 'high-density lipoprotein cholesterol', 'sedentary behavior', 'fat mass', 'moderate-to-vigorous PA', 'body composition, insulin sensitivity, and high-density lipoprotein cholesterol', 'body mass index', 'Insulin sensitivity', 'overall PA']","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",43.0,0.0263559,"However, 24% of patients decreased overall PA (P<.001), and 39% increased sedentary behavior (P<.001).","[{'ForeName': 'Jakob F', 'Initials': 'JF', 'LastName': 'Wefers', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Woodlief', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL.'}, {'ForeName': 'Elvis A', 'Initials': 'EA', 'LastName': 'Carnero', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Helbling', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Anthony', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Dubis', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Houmard', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC.'}, {'ForeName': 'Bret H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL; Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Coen', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL; Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, PA. Electronic address: paul.coen@flhosp.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2016.08.493']
856,31567304,"The Effect of Progressive Relaxation Exercises on Pain, Fatigue, and Quality of Life in Dialysis Patients.","Patients receiving hemodialysis treatment may experience several symptoms at the same time, such as fatigue and pain. Progressive relaxation exercises (PRE) have been reported to have positive effect on the control of these symptoms. In this study, a randomized, controlled, and experimental study was conducted to examine the effect of PRE on pain, fatigue, and quality of life in hemodialysis patients; the study was carried out with 48 intervention and 48 control patients receiving treatment in the hemodialysis units of 2 hospitals. Data were collected by a questionnaire prepared by the researcher, which included questions about sociodemographic variables and the disease; Piper Fatigue Scale; Visual Analog Scale that measures pain severity; and SF-36 Quality of Life Scale. The results of study revealed that mean total fatigue score and mean pain score decreased in the intervention group after the application of PRE; whereas no change was observed in the control group (P < .05). It was also found that quality of life physical component mean score and mental component mean score increased in the intervention group after the application of PRE (P < .05).",2020,It was also found that quality of life physical component mean score and mental component mean score increased in the intervention group after the application of PRE (P < .05).,"['Dialysis Patients', 'hemodialysis patients', '48 control patients receiving treatment in the hemodialysis units of 2 hospitals', 'Patients receiving']","['hemodialysis treatment', 'Progressive Relaxation Exercises', 'PRE', 'Progressive relaxation exercises (PRE']","['quality of life physical component mean score and mental component mean score', 'Pain, Fatigue, and Quality of Life', 'pain, fatigue, and quality of life', 'mean total fatigue score and mean pain score', 'disease; Piper Fatigue Scale; Visual Analog Scale that measures pain severity; and SF-36 Quality of Life Scale']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",,0.0169656,It was also found that quality of life physical component mean score and mental component mean score increased in the intervention group after the application of PRE (P < .05).,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kaplan Serin', 'Affiliation': 'School of Health, Munzur University, Tunceli, Turkey (Dr Serin); and Faculty of Health Science, Gaziantep University, Gaziantep, Turkey (Drs N. Ovayolu and Ö. O. Ovayolu).'}, {'ForeName': 'Nimet', 'Initials': 'N', 'LastName': 'Ovayolu', 'Affiliation': ''}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Ovayolu', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000347']
857,27943220,Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.,"BACKGROUND


Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE.
METHODS


We developed a population pharmacokinetic model for lorazepam using the NONMEM software. We then assessed exploratory exposure-response relationships using the overall efficacy and safety study endpoints, and performed dosing simulations.
RESULTS


A total of 145 patients contributed 439 pharmacokinetic samples. The median (range) age and dose were 5.4 years (0.3-17.8) and 0.10 mg/kg (0.02-0.18), respectively. A two-compartment pharmacokinetic model with allometric scaling described the data well. In addition to total body weight (WT), younger age was associated with slightly higher weight-normalized clearance (CL). The following relationships characterized the typical values for the central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q), using individual subject WT (kg) and age (years): V1 (L) = 0.879*WT; CL (L/h) = 0.115*(Age/4.7) 0.133 *WT 0.75 ; V2 (L) = 0.542*V1; Q (L/h) = 1.45*WT 0.75 . No pharmacokinetic parameters were associated with clinical outcomes. Simulations suggest uniform pediatric dosing (0.1 mg/kg, to a maximum of 4 mg) can be used to achieve concentrations of 50-100 ng/mL in children with SE, which have been previously associated with effective seizure control.
CONCLUSIONS


The population pharmacokinetics of lorazepam were successfully described using a sparse sampling approach and a two-compartment model in pediatric patients with active SE.",2017,No pharmacokinetic parameters were associated with clinical outcomes.,"['pediatric patients with active SE', 'infants and children aged 3\xa0months to 17\xa0years with active SE or a history of SE', 'Pediatric Status Epilepticus', '145 patients contributed 439 pharmacokinetic samples']","['Lorazepam', 'lorazepam']","['weight-normalized clearance (CL', 'central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.118065,No pharmacokinetic parameters were associated with clinical outcomes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Barrie', 'Initials': 'B', 'LastName': 'Harper', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics and Skaggs School of Pharmacy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093-0831, USA. ecapparelli@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-016-0486-0']
858,27616721,Robotic and Open Radical Prostatectomy: The First Prospective Randomised Controlled Trial Fuels Debate Rather than Closing the Question.,"Despite the finally acquired level 1 evidence, the urologic debate on open versus robotic prostatectomy still persists. This trial from Brisbane will encourage future studies that will better inform this debate and define what robotic surgery offers.",2017,"Despite the finally acquired level 1 evidence, the urologic debate on open versus robotic prostatectomy still persists.",[],['Robotic and Open Radical Prostatectomy'],[],[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]",[],,0.0482811,"Despite the finally acquired level 1 evidence, the urologic debate on open versus robotic prostatectomy still persists.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fossati', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Division of Oncology/Unit of Urology, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wiklund', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Charles-Henry', 'Initials': 'CH', 'LastName': 'Rochat', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Urology Department, Clinique Générale Beaulieu, Geneva, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Division of Oncology/Unit of Urology, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, Guys Hospital, London, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sanchez-Salas', 'Affiliation': ""EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, L'Institut Mutualiste Montsouris, Paris, France.""}, {'ForeName': 'Abdullah E', 'Initials': 'AE', 'LastName': 'Canda', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, Ankara Ataturk Hospital, Ankara, Turkey.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Piechaud', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Clinique Saint Augustin, Bordeaux, France.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Artibani', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, Verona University Hospital, Verona, Italy.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mottrie', 'Affiliation': 'EAU Robotic Urology Section, European Association of Urology, Arnhem, The Netherlands; Department of Urology, O.L.V. Clinic, Aalst, Belgium. Electronic address: alex.mottrie@orsi.be.'}]",European urology,['10.1016/j.eururo.2016.08.068']
859,27576880,Percutaneous Nephrolithotomy Using Split Amplatz Sheath: A Randomized Clinical Trial.,"PURPOSE


To compare the outcome of percutaneous nephrolithotomy (PCNL) using split or intact Amplatz sheath.
MATERIALS AND METHODS


Seventy two patients who underwent PCNL were randomly divided into two groups; PCNL using intact (group 1) and split (group 2) Amplatz sheath. Preoperative data, operative time, largest extracted stone size, fluoroscopy and lithotripsy time, and serum biochemistry tests before and after PCNL were evaluated.
RESULTS


Preoperative features and stone size were not significantly different between the groups. There were no significant differences in complications and postoperative changes in hemoglobin and serum electrolytes. Stone free rate in group 2 (88.1%) was insignificantly higher than group 1 (83.3%) (p = .05), but in staghorn stones and stones larger than 1000 mm2, stone free rate in group 2 was significantly higher than group 1 (82% vs. 72%). The mean extracted stone size in group 2 (150 &plusmn; 49) was significantly larger than group 1 (40 &plusmn; 16 mm2) (p &lt; .005). The mean operative, lithotripsy and fluoroscopy times were significantly longer in group 1.
CONCLUSION


Using split Amplatz sheath in PCNL facilitates extraction of larger stone fragments which could contribute to shorter fluoroscopy, lithotripsy and operative times.&nbsp.",2016,"The mean operative, lithotripsy and fluoroscopy times were significantly longer in group 1.
",['Seventy two patients who underwent PCNL'],"['percutaneous nephrolithotomy (PCNL) using split or intact Amplatz sheath', 'Percutaneous Nephrolithotomy Using Split Amplatz Sheath', 'PCNL using intact (group 1) and split (group 2) Amplatz sheath']","['complications and postoperative changes in hemoglobin and serum electrolytes', 'mean extracted stone size', 'Preoperative data, operative time, largest extracted stone size, fluoroscopy and lithotripsy time, and serum biochemistry tests', 'stone size', 'mean operative, lithotripsy and fluoroscopy times', 'stone free rate', 'staghorn stones and stones larger', 'Stone free rate']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0332249', 'cui_str': 'Staghorn (qualifier value)'}]",72.0,0.0204349,"The mean operative, lithotripsy and fluoroscopy times were significantly longer in group 1.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tabibi', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran,Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Abedi', 'Affiliation': 'Urology and Nephrology Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Radfar', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran,Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Kamranmanesh', 'Affiliation': 'Anesthesiology Research Center, Shahid Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Yazd University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Kerman University of Medical Sciences, Kerman, Iran.'}]",Urology journal,[]
860,27576882,Comparison of the Efficacy and Safety of Laparoendoscopic Single-Site Surgery with Conventional Laparoscopic Surgery for Upper Ureter or Renal Pelvis Stones in a Single Institution: A Randomized Controlled Study.,"PURPOSE


To evaluate the utility and safety of laparoendoscopic single-site surgery (LESS) in comparison with conventional laparoscopic (CL) surgery for the treatment of upper urinary tract stones.
MATERIAL AND METHODS


Between June 2011 and May 2012, 20 patients with upper urinary tract stones were included in this prospective randomized study. The patients were assigned into the LESS group or CL group in a one-on-one manner using a random table. The clinical parameters were evaluated in the immediate postoperative period, and the stone clearance rate was evaluated via non-contrast computer tomography at one month postoperatively.
RESULTS


There were no significant differences in patient demographics or preoperative stone sizes between the two groups. The perioperative parameters, including operative time, estimated blood loss, postoperative pain scores, length of hospital stay, and changes in renal function, were comparable. No transfusions or open conversions were required in either group. The incidence of residual stones was lower in the LESS group (1 case) than in the CL group (2 cases). However, this difference was not statistically significant.
CONCLUSIONS


For large and impacted upper ureteral stones, the effectiveness and safety of LESS were equivalent to those of CL. Further randomized control trials with larger sample sizes are needed to strengthen the conclusions of this study.&nbsp.",2016,The incidence of residual stones was lower in the LESS group (1 case) than in the CL group (2 cases).,"['Upper Ureter or Renal Pelvis Stones in a Single Institution', 'Between June 2011 and May 2012, 20 patients with upper urinary tract stones']","['Laparoendoscopic Single-Site Surgery with Conventional Laparoscopic Surgery', 'laparoendoscopic single-site surgery (LESS', 'LESS group or CL', 'conventional laparoscopic (CL) surgery', 'LESS']","['stone clearance rate', 'effectiveness and safety of LESS', 'incidence of residual stones', 'operative time, estimated blood loss, postoperative pain scores, length of hospital stay, and changes in renal function', 'patient demographics or preoperative stone sizes']","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0227666', 'cui_str': 'Kidney Pelvis'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042018', 'cui_str': 'Urinary Tract Stones'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",20.0,0.0526568,The incidence of residual stones was lower in the LESS group (1 case) than in the CL group (2 cases).,"[{'ForeName': 'Juhyun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Seung Bae', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Chang Wook', 'Initials': 'CW', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hwancheol', 'Initials': 'H', 'LastName': 'Son', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Hyeon Hoe', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'IslahMunjih Ab', 'Initials': 'IA', 'LastName': 'Rashid', 'Affiliation': 'Urology Unit, Department of Surgery, International Islamic University Malaysia, Kuala Lumpur, Malasyia.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea. drjh@brm.co.kr.'}]",Urology journal,[]
861,32492168,A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood.,"BACKGROUND


Acylcarnitines (ACs) play a major role in fatty acid metabolism and are potential markers of metabolic dysfunction with higher blood concentrations reported in obese and diabetic individuals. Diet, and in particular red and processed meat intake, has been shown to influence AC concentrations but data on the effect of meat consumption on AC concentrations is limited.
OBJECTIVES


To investigate the effect of red and processed meat intake on AC concentrations in plasma and urine using a randomized controlled trial with replication in an observational cohort.
METHODS


In the randomized crossover trial, 12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each. A panel of 44 ACs including several oxidized ACs was analyzed by LC-MS in plasma and urine samples collected after the 3-d period. ACs that were associated with pork intake were then measured in urine (n = 474) and serum samples (n = 451) from the European Prospective Investigation into Cancer and nutrition (EPIC) study and tested for associations with habitual red and processed meat intake derived from dietary questionnaires.
RESULTS


In urine samples from the intervention study, pork intake was positively associated with concentrations of 18 short- and medium-chain ACs. Eleven of these were also positively associated with habitual red and processed meat intake in the EPIC cross-sectional study. In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
CONCLUSIONS


AC concentrations in urine and blood were associated with red meat intake in both a highly controlled intervention study and in subjects of a cross-sectional study. Our data on the role of meat intake on this important pathway of fatty acid and energy metabolism may help understanding the role of red meat consumption in the etiology of some chronic diseases. This trial was registered at Clinicaltrials.gov as NCT03354130.",2020,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","['12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each', 'obese and diabetic individuals', 'human urine and blood']",['red and processed meat intake'],"['red meat intake', 'habitual red and processed meat intake', 'several oxidized ACs']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}]","[{'cui': 'C0556202', 'cui_str': 'Red meat intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}]",12.0,0.0566447,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wedekind', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Keski-Rahkonen', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Viallon', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Agnetha Linn', 'Initials': 'AL', 'LastName': 'Rostgaard-Hansen', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Torkjel M', 'Initials': 'TM', 'LastName': 'Sandanger', 'Affiliation': 'Department of Community Medicine, UiT the Arctic university of Norway, Tromsø, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jakszyn', 'Affiliation': 'Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmidt', 'Affiliation': 'Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pala', 'Affiliation': 'Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano,Italy.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Vermeulen', 'Affiliation': 'Division of Environmental Epidemiology, \xa0Institute for Risk Assessment Sciences, Utrecht University, \xa0Utrecht, The Netherlands.'}, {'ForeName': 'Matthias B', 'Initials': 'MB', 'LastName': 'Schulze', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Theron', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Trichopoulou', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Peppa', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'La Vechia', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masala', 'Affiliation': 'Cancer Risk Factors and Life-Style\xa0Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO) , Florence, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Tumino', 'Affiliation': 'Cancer Registry and Histopathology Department, Provincial Health Authority (ASP) Ragusa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Sacerdote', 'Affiliation': 'Unit of Cancer Epidemiology, Città della Salute e della Scienza University-Hospital and Center for Cancer Prevention (CPO), Turin, Italy.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wittenbecher', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Maria Santucci', 'Initials': 'MS', 'LastName': 'de Magistris', 'Affiliation': 'Azienda Ospedialiera Universitaria (A.O.U.) Federico II, Naples, Italy.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Dahm', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Severi', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Francesca Romana', 'Initials': 'FR', 'LastName': 'Mancini', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Weiderpass', 'Affiliation': 'International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Huybrechts', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa140']
862,27687820,Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial.,"BACKGROUND


Solifenacin, an effective, well-tolerated treatment for adult overactive bladder (OAB) symptoms, has not been evaluated in placebo-controlled paediatric clinical trials.
OBJECTIVES


To evaluate the efficacy and safety of once-daily oral solifenacin suspension in OAB patients aged 5-<12 yr (children) and 12-<18 yr (adolescents).
DESIGN, SETTING, AND PARTICIPANTS


The study involved a 4-wk urotherapy run-in followed by 1:1 randomisation to 12-wk double-blind solifenacin or placebo treatment alongside urotherapy.
INTERVENTION


Solifenacin paediatric equivalent doses (PEDs) of adult doses: 2.5mg, 5mg, 7.5mg, and 10mg. The starting dose was PED 5mg; all patients were titrated to an optimum dose at 3-wk intervals over 9 wk, resulting in ≥3 wk at the optimum dose before end of treatment (EoT).
OUTCOME MEASUREMENTS AND STATISTICS


Superiority of solifenacin versus placebo in change from baseline to EoT for mean volume voided/micturition (MVV, primary endpoint); daytime maximum volume voided/micturition (DMaxVV); incontinence episodes (mean/24h); mean number of incontinence-free days or nights/7 d; micturition frequency; and Micturition frequency adjusted for baseline total voided volume (VT B ) as an exploratory parameter). Efficacy parameters were analysed using analysis of covariance. Safety parameters (treatment-emergent adverse events, serious adverse events, laboratory variables, vital signs, electrocardiogram, postvoid residual volume) are summarised using descriptive statistics.
RESULTS AND LIMITATIONS


In children, solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV (solifenacin-placebo difference 12.1ml, 95% confidence interval [CI] 0.2-24.0; p=0.046), DMaxVV (difference in adjusted mean change from baseline for solifenacin-placebo 31.9ml, 95% CI 4.3-59.5; p=0.024), VT B -adjusted micturition frequency (p=0.028). Other endpoints were not significantly different. Solifenacin was well tolerated. For adolescents, it was not possible to draw firm efficacy conclusions because of the low numbers recruited.
CONCLUSIONS


Once-daily solifenacin oral suspension in children with OAB was superior to placebo for MVV (primary efficacy endpoint) and was well tolerated.
PATIENT SUMMARY


In this 12-wk study, a once-daily oral suspension of solifenacin in children aged 5-<12 yr with overactive bladder was superior to placebo in increasing mean volume voided/micturition, the primary efficacy variable in the study. Solifenacin was well tolerated, with a low incidence of dry mouth and constipation. This study is registered at ClinicalTrials.gov as NCT01565707.",2017,"In children, solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV (","['OAB patients aged 5-<12 yr (children) and 12-<18 yr (adolescents', 'children aged 5-<12 yr with overactive bladder', 'adult overactive bladder (OAB) symptoms', 'children with OAB', 'Children and Adolescents with Overactive Bladder']","['solifenacin suspension', 'placebo', 'solifenacin versus placebo', 'oral suspension of solifenacin', 'Solifenacin paediatric equivalent doses (PEDs', 'solifenacin-placebo', 'solifenacin or placebo', 'Solifenacin']","['efficacy and safety', 'DMaxVV', 'tolerated', 'mean volume voided/micturition (MVV, primary endpoint); daytime maximum volume voided/micturition (DMaxVV); incontinence episodes (mean/24h); mean number of incontinence-free days or nights/7 d; micturition frequency; and Micturition frequency adjusted for baseline total voided volume (VT B ', 'VT B -adjusted micturition frequency', 'Safety parameters (treatment-emergent adverse events, serious adverse events, laboratory variables, vital signs, electrocardiogram, postvoid residual volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}]",,0.599552,"In children, solifenacin was superior to placebo in terms of the change from baseline to EoT for MVV (","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Newgreen', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands. Electronic address: donald.newgreen@astellas.com.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bosman', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Hollestein-Havelaar', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Dahler', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Sawyer', 'Affiliation': 'Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bolduc', 'Affiliation': 'CHU de Québec, Division of Urology, Québec, Canada.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rittig', 'Affiliation': 'Aarhus University Hospital, Department of Paediatrics, Aarhus, Denmark.'}]",European urology,['10.1016/j.eururo.2016.08.061']
863,27734422,Retrograde Intrarenal Surgery Versus Shock Wave Lithotripsy for Renal Stones Smaller Than 2 cm: A Randomized Clinical Trial.,"PURPOSE


To compare outcomes of retrograde intrarenal surgery (RIRS) with extracorporeal shock wave lithotripsy (SWL) for stones &le; 2 cm.
MATERIALS AND METHODS


Patients who were diagnosed with kidney stones of &le; 2 cm underwent RIRS or SWL in a parallel group randomized clinical trial with balanced randomization [1:1] from 2011 to 2014. The primary outcome of interest was stone free rate after a single session intervention. Patients were evaluated by ultrasonography and KUB at 1 and 3 months after the intervention for the presence of residual stone by a radiologist who was blinded to the study.
RESULTS


The stone free rate one month after a single session intervention in the RIRS group was higher than the SWL group (90% versus 75%, P = .03). The success rates after two sessions of RIRS versus SWL were 96.7% versus 88.3% respectively. (P = .08) Patients in the RIRS group had significantly lower postoperative visual analogue pain score compared to the SWL group (5.2 &plusmn; 2.8 versus 3.1 &plusmn; 2.7, P &lt; .001). Steinstrasse formation and renal hematoma were observed in 4 and one patient in the SWL group versus no patient in the RIRS group. Postoperative hospital stay was significantly shorter in the SWL group (6.7 &plusmn; 1.3 versus18.9 &plusmn; 4.3 hours, P &lt; .001).
CONCLUSION


The RIRS procedure is a safe treatment option for renal stones of &le;2cm with less pain and higher success rate at first session compared to SWL.&nbsp.",2016,"The stone free rate one month after a single session intervention in the RIRS group was higher than the SWL group (90% versus 75%, P = .03).","['Patients who were diagnosed with kidney stones of &le', 'Renal Stones', 'Smaller Than 2 cm']","['retrograde intrarenal surgery (RIRS', 'RIRS or SWL', 'extracorporeal shock wave lithotripsy (SWL', 'Retrograde Intrarenal Surgery Versus Shock Wave Lithotripsy', 'SWL']","['Postoperative hospital stay', 'success rates', 'Steinstrasse formation and renal hematoma', 'postoperative visual analogue pain score', 'stone free rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0403718', 'cui_str': 'Steinstrasse (disorder)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0475022', 'cui_str': 'Hematoma of kidney (disorder)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",,0.0730112,"The stone free rate one month after a single session intervention in the RIRS group was higher than the SWL group (90% versus 75%, P = .03).","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Javanmard', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. drbabakjavanmard@gmail.com.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Kashi', 'Affiliation': 'Hasheminejad Kidney Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mohsen', 'Initials': 'MM', 'LastName': 'Mazloomfard', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Ansari Jafari', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Arefanian', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, Saint Louis, Missouri, United States.'}]",Urology journal,[]
864,31848889,Acupuncture Combined with Early Enteral Nutrition on Patients with Postoperative Laparoscopic Common Bile Duct Exploration: A Prospective Randomized Trial.,"OBJECTIVE


To assess the efficiency of acupuncture combined with early enteral nutrition (EEN) in patients with postoperative laparoscopic common bile duct exploration.
METHODS


A total of 200 patients with postoperative laparoscopic bile duct exploration was randomized using sealed envelopes and assigned to the convenitional, EEN, acupuncture plus convenitional and acupuncture plus EEN groups, 50 cases in each group. Twelve hours after operation, the patients in EEN groups began to receive oral enteral nutrition, and the acupuncture approach was performed by acupuncturist in acupuncture plus conventional and acupuncture plus EEN groups. Acupuncture was given at Zusanli (ST 36), Shangjuxu (ST 37) and Xiajuxu (ST 39) with a depth of 15-20 mm, using the lifting-thrusting and twisting method to obtain Deqi sensation. The needles were maintained for 30 min. Treatment was given once daily, 3 times per section. After the intervention, the patients' characteristics, operation time, bleeding volume, postoperative time to first anal exhaust, postoperative complications including abdominal distension, diarrhea, gastric dilatation, intestinal obstruction, pharyngodynia, incision, abdominal and pulmonary infection and postoperative hospitalization days were assessed and compared in patients among 4 groups.
RESULTS


Postoperative time to first anal exhaust in the convenitional group was longer compared with the other 3 groups (P<0.05), and was shorter in the acupuncture plus EEN group than those of the convenitional, acupuncture plus convenitional and EEN groups (P<0.01). The acupuncture plus EEN group showed significant decrease in the incidence of complications and less postoperative hospitalization days compared with the other groups (P<0.05 or P<0.01). There was no readmission.
CONCLUSION


After laparoscopic bile duct exploration, acupuncture combined with EEN treatment significantly improves the patients' gastrointestinal function, reduces complications, and shortens postoperative hospitalization days.",2020,The acupuncture plus EEN group showed significant decrease in the incidence of complications and less postoperative hospitalization days compared with the other groups (P<0.05 or P<0.01).,"['patients with postoperative laparoscopic common bile duct exploration', 'Patients with Postoperative Laparoscopic Common Bile Duct Exploration', '200 patients with postoperative laparoscopic bile duct exploration']","['Acupuncture Combined with Early Enteral Nutrition', 'acupuncture plus conventional and acupuncture plus EEN', 'Acupuncture', 'acupuncture combined with early enteral nutrition (EEN', 'acupuncture combined with EEN', 'convenitional, EEN, acupuncture plus convenitional and acupuncture plus EEN', 'acupuncture plus EEN']","[""patients' characteristics, operation time, bleeding volume, postoperative time to first anal exhaust, postoperative complications including abdominal distension, diarrhea, gastric dilatation, intestinal obstruction, pharyngodynia, incision, abdominal and pulmonary infection and postoperative hospitalization days"", 'readmission', 'Postoperative time to first anal exhaust', ""patients' gastrointestinal function, reduces complications, and shortens postoperative hospitalization days"", 'incidence of complications and less postoperative hospitalization days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009437', 'cui_str': 'Choledochus'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0400704', 'cui_str': 'Exploration of bile duct (procedure)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0231226', 'cui_str': 'Exhausting (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038353', 'cui_str': 'Gastric Dilatation'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}, {'cui': 'C3854543', 'cui_str': 'Pharyngodynia'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",200.0,0.0815501,The acupuncture plus EEN group showed significant decrease in the incidence of complications and less postoperative hospitalization days compared with the other groups (P<0.05 or P<0.01).,"[{'ForeName': 'Hai-Cheng', 'Initials': 'HC', 'LastName': 'Yuan', 'Affiliation': 'Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, 300100, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, Tianjin, 300100, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin, 300100, China. ironyhc2002@163.com.'}, {'ForeName': 'Wei-Jing', 'Initials': 'WJ', 'LastName': 'Qin', 'Affiliation': 'Department of Acupuncture, Tianjin Nankai Hospital, Tianjin, 300100, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin, 300100, China.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-3048-0']
865,27401564,Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.,"Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.",2016,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"['premature infants using the final PK model', 'extremely premature infants', '141 infants using 604 plasma samples', 'infants with birth weights of <750 g', 'premature infants', 'Premature Infants with Birth Weights Less than 750 Grams', 'infants born at <750 g birth weight received']","['fluconazole', 'intravenous (i.v.) or oral fluconazole', 'Fluconazole']","['oral bioavailability', 'Fluconazole plasma concentrations']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0306005,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"[{'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kantak', 'Affiliation': ""Children's Hospital Medical Center of Akron, Akron, Ohio, USA.""}, {'ForeName': 'Ramasubbareddy', 'Initials': 'R', 'LastName': 'Dhanireddy', 'Affiliation': 'University of Tennessee Health System, Memphis, Tennessee, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'East Carolina University, Brody School of Medicine, Greenville, North Carolina, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Nedrelow', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, Texas, USA.""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida, USA.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York, USA.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Laughon', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA brian.smith@duke.edu.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00963-16']
866,32415575,"Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).","INTRODUCTION


Patients with plaque psoriasis often have nail psoriasis, which is difficult to treat. Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis. We present post hoc data from a head-to-head trial of IXE and UST (IXORA-S) to examine the efficacy in nail psoriasis in patients with moderate-to-severe plaque psoriasis over 52 weeks.
METHODS


In IXORA-S,  randomised patients received IXE (N = 136) or UST (N = 166) per label for 52 weeks. Eighty-four (61.8%) and 105 (63.3%) of the patients treated with IXE or UST, respectively, had baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI] > 0); of these, 54 (64.3%) and 63 (60.0%) patients, respectively, had significant baseline fingernail psoriasis (defined as NAPSI ≥ 16 with ≥ 4 fingernails involved). The proportion of patients achieving NAPSI = 0, a NAPSI score change from baseline and correlations in Psoriasis Area of Severity Index (PASI) and NAPSI improvement over 52 weeks were examined.
RESULTS


Progressive improvement occurred in both treatment groups over 52 weeks. Statistically significantly more patients achieved NAPSI = 0 with IXE versus UST by week 16-20, and the proportions continued to increase through week 52 among patients with baseline nail psoriasis (61.9 vs. 28.6%, respectively; P < 0.001), including those with significant nail psoriasis (57.4 vs. 17.5%, respectively; P < 0.001). Similar results were observed for NAPSI score improvement from baseline to week 52. Interestingly, the presence of nail psoriasis was associated with lower skin response with UST but not with IXE.
CONCLUSIONS


Ixekizumab was superior to UST in the clearance of nail psoriasis, with earlier improvement continued through 52 weeks regardless of baseline nail severity.
TRIAL REGISTRATION


ClinicalTrials.gov identifier; NCT02561806.",2020,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"['patients with moderate-to-severe plaque psoriasis over 52\xa0weeks', 'Patients with plaque psoriasis often have nail psoriasis', 'nail psoriasis', 'Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis']","['IXE and UST (IXORA-S', 'IXE or UST', 'IXE', 'Ixekizumab', 'Ixekizumab (IXE) and ustekinumab (UST', 'UST']","['Psoriasis Area of Severity Index (PASI) and NAPSI improvement', 'nail psoriasis', 'NAPSI score improvement', 'baseline fingernail psoriasis (Nail Psoriasis Severity Index [NAPSI', 'Progressive improvement', 'skin response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}]",,0.0802576,Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.,"[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wasel', 'Affiliation': 'Stratica Medical and Probity Medical Research, Edmonton, AB, Canada. nwasel@straticamedical.com.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'French', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich (LMU Munich), Munich, Germany.'}, {'ForeName': 'Curdin', 'Initials': 'C', 'LastName': 'Conrad', 'Affiliation': 'Department of Dermatology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dutronc', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lovisa', 'Initials': 'L', 'LastName': 'Berggren', 'Affiliation': 'HaaPACS GmbH, Schriesheim, Germany.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, University Hospital of Nice-Côte d'Azur, Nice, France.""}]",Dermatology and therapy,['10.1007/s13555-020-00383-x']
867,32004243,Adherence to guidelines in the management of patients with chronic heart failure follow-up: role of periodic echocardiographic examinations.,"BACKGROUND AND AIM


The Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure trial showed a poor adherence to the current therapeutic guidelines in 660 chronic heart failure (CHF) patients. The second phase, Adherence to Guidelines in the Treatment of patients with Chronic Heart Failure follow-up, was aimed to determine if periodic echocardiographic evaluations could improve the prognosis of CHF patients and/or increase the adherence to the guidelines.
MATERIAL AND METHODS


Among 528 CHF patients with reduced ejection fraction from the ALERT registry, 436 patients accepted to participate in the second phase of the study between February and September 2013 and completed the 3-year follow-up phase between February and September 2016. They were randomized into two groups: Group A (n = 218) followed by clinical evaluation and ECG every 3 months, and echocardiography every 6 months and Group B (n = 218) monitored only with clinical evaluation and ECG every 3 months.
RESULTS


The number of vascular events that occurred resulted as similar in both the groups: there were 78 hospitalizations (37 in Group A vs. 41 in Group B); 9 home-treated vascular events (4 in Group A and five in Group B); and 16 cardiovascular deaths (9 and 7, respectively). The adherence to the guidelines at the end of the trial resulted as significantly improved in both the groups in comparison with the basal evaluation, without differences between the two groups.
CONCLUSION


A strict follow-up of CHF patients was associated with a lower number of events and an improvement in the adherence to the guidelines. Periodic echocardiography does not modify these results.",2020,"The adherence to the guidelines at the end of the trial resulted as significantly improved in both the groups in comparison with the basal evaluation, without differences between the two groups.
","['patients with chronic heart failure follow-up', 'patients with Chronic Heart Failure follow-up', '660 chronic heart failure (CHF) patients', 'patients with Chronic Heart Failure trial', '528 CHF patients with reduced ejection fraction from the ALERT registry, 436 patients accepted to participate in the second phase of the study between February and September 2013 and completed the 3-year follow-up phase between February and September 2016']",[],['number of vascular events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",528.0,0.0175615,"The adherence to the guidelines at the end of the trial resulted as significantly improved in both the groups in comparison with the basal evaluation, without differences between the two groups.
","[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bosso', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Valvano', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Guarnaccia', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Fimiani', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Carbone', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Battista', 'Initials': 'GB', 'LastName': 'Zito', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Oliviero', 'Affiliation': 'A.R.C.A. Associazioni Regionali Cardiologi Ambulatoriali.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cardiovascular medicine (Hagerstown, Md.)",['10.2459/JCM.0000000000000940']
868,32492654,The Placebo Effect in Sport: How Practitioners Can Inject Words to Improve Performance.,,2020,,['Sport'],['Placebo'],[],"[{'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.105088,,"[{'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Roelands', 'Affiliation': 'Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hurst', 'Affiliation': 'Canterbury Christ Church University, United Kingdom.'}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0358']
869,32415309,[Improve Hip Fracture Outcome In The Elderly Patient (iHOPE): a multicentre randomized controlled trial to test the efficacy of spinal versus general anaesthesia].,,2020,,['Elderly Patient'],['spinal versus general anaesthesia'],['Hip Fracture Outcome'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0763614,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kowark', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsklinikum RWTH Aachen, Pauwelsstr.\xa030, 52074, Aachen, Deutschland. akowark@ukaachen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Der Anaesthesist,['10.1007/s00101-020-00785-8']
870,31566030,An assessment of urine THC immunoassay in healthy volunteers receiving an oral proton-pump inhibitor.,"Introduction:  Limitations of urine drug-screening (UDS) by immunoassay include false-positive results. Pantoprazole, a proton-pump inhibitor (PPI), is reported to cause false-positive results for THC on UDS. The objective of this study was to determine if oral PPIs cause false-positive THC results using the THC One Step Marijuana Test Strip ® . Methods:  Eligible healthy volunteers completed a 5-day course of a PPI followed by urine testing using the THC One Step Marijuana Test Strip ® . Phase one included 3 subjects taking pantoprazole 40 mg once daily for 5 days. On day 5, urine specimens underwent THC screening. Phase two included 9 subjects randomized to 5-day supply of once-daily oral esomeprazole 20 mg, lansoprazole 15 mg, or omeprazole 20 mg. All study methods and testing mirrored those in phase one. Results:  All 12 subjects completed the study protocol. All urine samples collected on day 5 were negative for THC in all subjects. Discussion:  Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® . Limitations include small sample size, use of a single commercial immunoassay, and inability to confirm medication compliance. Further, large-scale research using other commercial urine immunoassays is warranted.",2020,Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® .,"['Eligible healthy volunteers completed a 5-day course of a PPI followed by urine testing using the THC One Step Marijuana Test Strip ® ', 'healthy volunteers receiving an oral proton-pump inhibitor', 'All 12 subjects completed the study protocol']","['pantoprazole', '5-day supply of once-daily oral esomeprazole 20\u2009mg, lansoprazole 15\u2009mg, or omeprazole', 'Pantoprazole, a proton-pump inhibitor (PPI', 'urine drug-screening (UDS']",['urine THC immunoassay'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0042037'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1553116', 'cui_str': 'Test strip technique'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C1145804', 'cui_str': 'lansoprazole 15 MG'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]","[{'cui': 'C0042037'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay'}]",9.0,0.0394035,Our results demonstrate that oral PPIs did not cause a false-positive THC using the THC One Step Marijuana Test Strip ® .,"[{'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Vohra', 'Affiliation': 'Upstate New York Poison Center, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Jeanna M', 'Initials': 'JM', 'LastName': 'Marraffa', 'Affiliation': 'Upstate New York Poison Center, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Wojcik', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Eggleston', 'Affiliation': 'Department of Emergency Medicine, SUNY Upstate Medical University, Syracuse, NY, USA.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1662917']
871,26945658,A Prospective Randomized Trial Comparing a Combined Regimen of Amikacin and Levofloxacin to Levofloxacin Alone as Prophylaxis in Transrectal Prostate Needle Biopsy.,"PURPOSE


We investigated whether addition of amikacin to levofloxacin-based antimicrobial prophylaxis reduces febrile urinary tract infections after transrectal ultrasound-guided prostate needle biopsy (TRUSB).
MATERIALS AND METHODS


A total of 447 patients undergoing TRUSB were prospectively randomized into two groups. The 230 patients in Group A were given one oral dose of levofloxacin 400 mg prior to TRUSB; the 217 patients in Group B each received the same dose of levofloxacin and one 200 mg intravenous dose of amikacin. Patients' characteristics were assessed prior to TRUSB and their symptoms were checked after the TRUSB.
RESULTS


Both regimens were well tolerated with no side effects. No statistically significant difference in patients' characteristics, or in incidence of inflammation- or infection-related symptoms was seen between the two groups; nor any significant difference among those who developed fever and those who did not. Two Group A patients and one Group B patient developed febrile urinary tract infections. Accountable pathogens determined by urine and blood cultures were fluoroquinolone-resistant E.coli and extended-spectrum β-lactamase-producing E.coli. All pathogens isolated were levofloxacin-resistant, amikacin-susceptible species.
CONCLUSION


Although the present study was under-powered by unexpectedly low overall incidence of febrile urinary tract infections, addition of one intravenous administration of amikacin to one oral administration of levofloxacin showed no advantage compared with levofloxacin alone as antimicrobial prophylaxis in TRUSB. Strikingly, all pathogens isolated from febrile patients were sensitive to amikacin in vitro. Therefore, further understanding of amikacin's drug kinetics in the prostate is necessary to develop a more efficient drug delivery system for amikacin.",2016,"No statistically significant difference in patients' characteristics, or in incidence of inflammation- or infection-related symptoms was seen between the two groups; nor any significant difference among those who developed fever and those who did not.","['Transrectal Prostate Needle Biopsy', '447 patients undergoing TRUSB']","['levofloxacin 400 mg prior to TRUSB', 'Amikacin and Levofloxacin to Levofloxacin Alone', 'amikacin', 'amikacin to levofloxacin-based antimicrobial prophylaxis', 'levofloxacin', 'levofloxacin and one 200 mg intravenous dose of amikacin', 'transrectal ultrasound-guided prostate needle biopsy (TRUSB']","['febrile urinary tract infections', 'incidence of inflammation- or infection-related symptoms']","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}]","[{'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",447.0,0.0303011,"No statistically significant difference in patients' characteristics, or in incidence of inflammation- or infection-related symptoms was seen between the two groups; nor any significant difference among those who developed fever and those who did not.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. akamats@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Sojun', 'Initials': 'S', 'LastName': 'Kanamaru', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sengiku', 'Affiliation': 'Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Iguchi', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takenawa', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Nishi-Kobe Medical Center, 7-1 Kojidai 5-Chome, Nishi-Ku, Kobe City, Hyogo, 651-2273, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Ogura', 'Affiliation': 'Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.'}]",Urology journal,[]
872,26571323,Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate.,"PURPOSE


Elderly patients under spinal anesthesia are vulnerable to hypothermia, leading to increased morbidity. The aim of this study was to investigate the effects of preoperative forced-air warming on perioperative hypothermia and shivering in elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia.
MATERIALS AND METHODS


Patients (> 65-year-old) scheduled for TURP under spinal anesthesia were randomly assigned to receive preoperative forced-air skin warming for 20 min (the pre-warmed group, n = 25) or not (control group, n = 25). Core temperatures were measured at 15-min intervals after spinal anesthesia, and intra- and post-operative shivering were also assessed.
RESULTS


Incidences of intraoperative hypothermia (< 36 ºC) in the pre-warmed and control groups were not significantly different (10/25 [40%] vs. 15/24 [62.5%], P = .259). However, severities of hypothermia were significantly different (P = .019). No patient in the pre-warmed group showed moderate or profound hypothermia, whereas of patients in control group 21% and 13% did so, respectively.
CONCLUSION


This study demonstrated that a brief period of preoperative forced-air warming did not completely prevent intraoperative hypothermia or shivering, but it could significantly reduce its severity in elderly male patients under spinal anesthesia.",2015,"RESULTS


Incidences of intraoperative hypothermia (< 36 ºC) in the pre-warmed and control groups were not significantly different (10/25 [40%] vs. 15/24 [62.5%], P = .259).","['elderly male patients under spinal anesthesia', 'elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia', 'Elderly Patients Undergoing Transurethral Resection of the Prostate', 'Patients (> 65-year-old) scheduled for TURP under spinal anesthesia', 'Elderly patients under spinal anesthesia']","['preoperative forced-air skin warming for 20 min (the pre-warmed group, n = 25) or not (control', 'Preoperative Forced-Air Warming', 'preoperative forced-air warming']","['severities of hypothermia', 'moderate or profound hypothermia', 'intraoperative hypothermia']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0235218', 'cui_str': 'Warm skin (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0445200', 'cui_str': 'Profound hypothermia (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",,0.0180554,"RESULTS


Incidences of intraoperative hypothermia (< 36 ºC) in the pre-warmed and control groups were not significantly different (10/25 [40%] vs. 15/24 [62.5%], P = .259).","[{'ForeName': 'Youn Yi', 'Initials': 'YY', 'LastName': 'Jo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Sehwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea. hyun615@gilhospital.com.'}]",Urology journal,[]
873,26571324,Benign Prostatic Hyperplasia Treatment with New Physiotherapeutic Device.,"PURPOSE


Thermobalancing therapy, provided by Therapeutic Device, which contains a natural thermoelement, and is applied topically in the projection ofthe prostate,was aimed to improve blood circulation in the affected organ. We evaluated the effectiveness of new Therapeutic Device for the treatment of patients with benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


We performed a clinical non-randomized controlled trial before and after 6-month treatment. Therapeutic Device was administered to 124 patients with BPH as mono-therapy. The dynamic of the patients' condition was assessed by the International Prostate Symptom Score (IPSS), ultrasound measurement of prostate volume (PV) and uroflowmetry. The control-group comprised 124 men who did not receive any treatment. The IPSS score, maximum flow rate (Qmax), and PV were compared between the groups.
RESULTS


Baseline evaluation (pre-treatment) for both groups were comparable to each other with no clinically significant difference regarding age, IPSS score, Qmax and PV volume. Overall, thermobalancing therapy resulted in significant improvements from baseline to endpoint in IPSS (P = .001), IPSS storage and voiding subscores (both P = .001), and IPSS quality of life index (QoL) (P = .001) compared with control group. Moreover, comparison of parameters after 6 months treatment showed that thermobalancing therapy also improved the Qmax (P = .001), and PV (P = .001).
CONCLUSION


Two years clinical trial demonstrated that thermobalancing therapy administered for 6 months provides a marked improvement in patients presenting with symptomatic BPH not only on lower urinary tract symptoms (LUTS) but also in QoL and Qmax. Thus urologists should be aware about thermobalancing therapy as a non-invasive physiotherapeutic treatment option for treatment of BPH.",2015,"Overall, thermobalancing therapy resulted in significant improvements from baseline to endpoint in IPSS (P = .001), IPSS storage and voiding subscores (both P = .001), and IPSS quality of life index (QoL)","['patients with benign prostatic hyperplasia (BPH', 'Benign Prostatic Hyperplasia Treatment with New Physiotherapeutic Device', '124 men who did not receive any treatment', '124 patients with BPH as mono-therapy']","['thermobalancing therapy', 'new Therapeutic Device']","['IPSS score, maximum flow rate (Qmax), and PV', 'urinary tract symptoms (LUTS', 'blood circulation', 'IPSS score, Qmax and PV volume', 'IPSS quality of life index (QoL', 'IPSS storage and voiding subscores', 'IPSS', 'International Prostate Symptom Score (IPSS), ultrasound measurement of prostate volume (PV) and uroflowmetry', 'Qmax']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry (procedure)'}]",124.0,0.0375124,"Overall, thermobalancing therapy resulted in significant improvements from baseline to endpoint in IPSS (P = .001), IPSS storage and voiding subscores (both P = .001), and IPSS quality of life index (QoL)","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Fine Treatment, 29 Rewley Road, Oxford, OX1 2RA, United Kingdom. info@finetreatment.com.'}, {'ForeName': 'Ivan Gerasimovich', 'Initials': 'IG', 'LastName': 'Aghajanyan', 'Affiliation': 'Department of Urology, Yerevan State Medical University, Institute of Surgery Mikaelyan, Republic of Armenia.'}]",Urology journal,[]
874,30859503,"Capsule Commentary on Anthenelli et al., Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.",,2019,,[],[],[],[],[],[],,0.052487,,"[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Young-Wolff', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04909-8']
875,27351320,Efficacy of Silodosin in Expulsive Therapy for Distal Ureteral Stones: A Randomized Double-blinded Controlled Trial.,"PURPOSE


To evaluate the efficacy of silodosin in the medical expulsive therapy for symptomatic distal ureteral stones.
MATERIALS AND METHODS


This prospectively randomized controlled trial was carried out from May 2011 to December 2014. In all, 198 patients with radiopaque distal ureteral stones &lt;10 mm in size were eligible: 61 patients in the control group and 62 patients in the silodosin group. The silodosin group received silodosin 8 mg daily, and the control group received lactose tablets. The primary outcome was the expulsion rate. The secondary outcomes the expulsion time, analgesic consumption, lower urinary tract symptoms, colic episodes, and adverse effects. Statistical analyses were performed using a Mann-Whitney U-test and chi-square test.
RESULTS


The final analysis was conducted with 61 control and 62 silodosin patients as the denominator in each randomization arm. The average expulsion times were 6.31 &plusmn; 2.13 days for the silodosin group and 9.73 &plusmn; 2.76 days for the control group (P &lt; .001).
CONCLUSION


Treatment with silodosin proved to be safe and effective, as demonstrated by the increased stone expulsion rate, the reduced expulsion time, and the reduced analgesics consumption.&nbsp.",2016,"CONCLUSION


Treatment with silodosin proved to be safe and effective, as demonstrated by the increased stone expulsion rate, the reduced expulsion time, and the reduced analgesics consumption.&nbsp.","['symptomatic distal ureteral stones', 'Distal Ureteral Stones', 'May 2011 to December 2014', '198 patients with radiopaque distal ureteral stones &lt;10 mm in size were eligible: 61 patients in the control group and 62 patients in the silodosin group']","['lactose tablets', 'silodosin', 'Silodosin']","['average expulsion times', 'safe and effective', 'expulsion time, analgesic consumption, lower urinary tract symptoms, colic episodes, and adverse effects', 'stone expulsion rate', 'expulsion rate']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1870115', 'cui_str': 'silodosin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1870115', 'cui_str': 'silodosin'}]","[{'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0232488', 'cui_str': 'Colic'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",198.0,0.178092,"CONCLUSION


Treatment with silodosin proved to be safe and effective, as demonstrated by the increased stone expulsion rate, the reduced expulsion time, and the reduced analgesics consumption.&nbsp.","[{'ForeName': 'Chung Jing', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Division of Urology, Saint Martin De Porres Hospital, Chiayi, Taiwan, R.O.C.'}, {'ForeName': 'Po Chao', 'Initials': 'PC', 'LastName': 'Tsai', 'Affiliation': 'Department of Surgery, Division of Urology, Saint Martin De Porres Hospital, Chiayi, Taiwan, R.O.C.'}, {'ForeName': 'Chien Hsing', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Surgery, Division of Urology, Saint Martin De Porres Hospital, Chiayi, Taiwan, R.O.C.'}]",Urology journal,[]
876,32026447,Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III.,"BACKGROUND/OBJECTIVE


Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
METHODS


In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
RESULTS


Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
CONCLUSIONS


Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.",2020,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.",['patients with dCT'],['WML'],"['absolute ICH expansion, ', 'ICH volume, intraventricular hemorrhage volume, warfarin/INR\u2009>\u20091.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location', 'Poor functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",635.0,0.141451,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.","[{'ForeName': 'Björn M', 'Initials': 'BM', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. nlullman@gmail.com.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Department of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-020-00916-4']
877,26614647,Immediate and Complex Cardiovascular Adaptation to an Acute Alcohol Dose.,"BACKGROUND


The detrimental effects of chronic heavy alcohol use on the cardiovascular system are well established and broadly appreciated. Integrated cardiovascular response to an acute dose of alcohol has been less studied. This study examined the early effects of an acute dose of alcohol on the cardiovascular system, with particular emphasis on system variability and sensitivity. The goal was to begin to understand how acute alcohol disrupts dynamic cardiovascular regulatory processes prior to the development of cardiovascular disease.
METHODS


Healthy participants (N = 72, age 21 to 29) were randomly assigned to an alcohol, placebo, or no-alcohol control beverage condition. Beat-to-beat heart rate (HR) and blood pressure (BP) were assessed during a low-demand cognitive task prior to and following beverage consumption. Between-group differences in neurocardiac response to an alcohol challenge (blood alcohol concentration ~ 0.06 mg/dl) were tested.
RESULTS


The alcohol beverage group showed higher average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity after alcohol consumption. No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content. At the level of the individual, an active alcohol dose appeared to disrupt the typically tight coupling between cardiovascular processes.
CONCLUSIONS


A dose of alcohol quickly invoked multiple cardiovascular responses, possibly as an adaptive reaction to the acute pharmacological challenge. Future studies should assess how exposure to alcohol acutely disrupts or dissociates typically integrated neurocardiac functions.",2015,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","['Healthy participants (N\xa0=\xa072, age 21 to 29']","['alcohol', 'placebo', 'alcohol, placebo, or no-alcohol control beverage condition']","['average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity', 'average HR and BP', 'Beat-to-beat heart rate (HR) and blood pressure (BP', 'neurocardiac response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0345724,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.12912']
878,26428452,Promoting Tdap immunization in pregnancy: Associations between maternal perceptions and vaccination rates.,"OBJECTIVE


Tdap vaccine uptake among US pregnant women is low despite current recommendations. This study evaluated if a Tdap vaccine information statement (VIS) affected overall perception, vaccination intention, and components of a health behavior model associated with Tdap vaccination rates.
METHODS


A randomized, prospective study was conducted among pregnant women receiving care at two women's clinics in May-August 2014. Verbally consented participants were randomized to receive either the standard CDC Tdap VIS (sVIS) or a modified version (mVIS) before completing the first multi-part survey (T1). After T1, participants read their assigned VIS then completed the second part (T2). A 2015 chart review identified vaccinated participants. A health behavior model was hypothesized using the Reasoned Action Approach and Health Belief Model. Logistic regression, path analysis, and chi-square tests were used in the analysis.
RESULTS


279 surveys were analyzed. Average age of the participants was 26.4 years (SD=5.7) with average gestational age of 25.9 weeks (SD=9.2). 13% self-reported receiving Tdap vaccine prior to the survey. Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review. A chart review showed that 131 (47%) received the vaccine post study. There was no significant difference in vaccination rates between the sVIS and mVIS groups (45% vs. 49%). Perceived benefits (B=0.315) and self-efficacy (B=0.197) were positively associated with the overall perception (T1), while perceived barriers (B=-0.191) were negatively associated with the overall perception (T1). Social norms (B=0.230), self-efficacy (B=0.213), and perceived benefits (B=0.117) were positively associated with vaccination intention (T1). The vaccination intention (T2) was positively associated with participants' decision to receive Tdap vaccine (B=0.223).
CONCLUSION


A VIS improved overall perception of the Tdap vaccine. Vaccination intention was a predictor of Tdap vaccination. It is crucial to provide information about immunization benefits to promote maternal Tdap vaccination.",2016,"Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review.","['US pregnant women', 'Average age of the participants was 26.4 years (SD=5.7) with average gestational age of 25.9 weeks (SD=9.2', ""pregnant women receiving care at two women's clinics in May-August 2014""]","['standard CDC Tdap VIS (sVIS) or a modified version (mVIS', 'Tdap vaccine', 'Tdap vaccine information statement (VIS']","['overall perception', 'Overall perception scores', 'vaccination rates', 'self-efficacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",279.0,0.0445838,"Overall perception scores significantly increased (3.1-3.4, p<0.001) after VIS review.","[{'ForeName': 'Nalin', 'Initials': 'N', 'LastName': 'Payakachat', 'Affiliation': 'Department of Pharmacy Practice, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA. Electronic address: npayakachat@uams.edu.'}, {'ForeName': 'Kristie B', 'Initials': 'KB', 'LastName': 'Hadden', 'Affiliation': 'Center for Health Literacy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Ragland', 'Affiliation': 'Department of Pharmacy Practice, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}]",Vaccine,['10.1016/j.vaccine.2015.09.062']
879,27085561,Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial.,"PURPOSE


The purpose of this study was to assess the impact of music on anxiety and perceived pain during transrectal ultrasound-guided prostate biopsy.
MATERIALS AND METHODS


Forty consecutive men with an elevated serum prostate specific antigen (PSA) level and/ or an abnormal digital rectal examination referred for transrectal ultrasound-guided prostate biopsy were recruited and allocated to a music (n = 20) or a non-music (n = 20) group. Anxiety was assessed prior to and after biopsy and pain was assessed after biopsy in each patient using visual analog scales (VAS) in the same setting, and group anxiety scores were compared.
RESULTS


Patients in the music group experienced less anxiety (P = .046) during the procedure, but group pain scores were not significantly different.
CONCLUSION


Music was found to decrease anxiety effectively during transrectal ultrasound-guided prostate biopsy.",2016,"RESULTS


Patients in the music group experienced less anxiety (P = .046) during the procedure, but group pain scores were not significantly different.
","['Forty consecutive men with an elevated serum prostate specific antigen (PSA) level and/ or an abnormal digital rectal examination referred for transrectal ultrasound-guided prostate biopsy were recruited and allocated to a music (n = 20) or a non-music (n = 20) group', 'Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies']","['Music', 'transrectal ultrasound-guided prostate biopsy']","['anxiety and perceived pain', 'anxiety', 'anxiety effectively', 'pain scores', 'Anxiety']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",40.0,0.138147,"RESULTS


Patients in the music group experienced less anxiety (P = .046) during the procedure, but group pain scores were not significantly different.
","[{'ForeName': 'Seong Whi', 'Initials': 'SW', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology, Kangwon National University Hospital, Chuncheon, Korea.'}, {'ForeName': 'Hyuck Jae', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Kangwon National University Hospital, Chuncheon, Korea.'}]",Urology journal,[]
880,27085565,Comparing the Effectiveness of Dietary Vitamin C and Exercise Interventions on Fertility Parameters in Normal Obese Men.,"PURPOSE


Comparing the effectiveness of dietary vitamin C and weight loss exercises interventions for weight loss on semen characteristics in normal obese man.
MATERIALS AND METHODS


A total number of 200 men were randomly allocated into two groups based on body mass index, exercise and vitamin C groups. Also, 50 men with normal spermogram were placed in a control group. In exercise group, a 6 months intensive exercise program was designed under a coach's supervision to reduce the body weight. In vitamin C group, 1,000 mg of vitamin C were given every other day as supplement.
RESULTS


Weight loss increased the volume of semen in participants with 25-30 (P = .02) and more than 30 body mass index (P = .001). The increased concentration of sperm per mL of semen in body mass index (BMI) 25-30 group (P = .01) and more than 30 (P = .003) BMI was significant. Improving sperm motility after two hours in participants with more than 30 (P = .01) BMI was significant. In vitamin C group, the improvement of sperm concentration in participants who had less than 25 (P = .01), between 25 and 30 (P = .01), more than 30 (P = .02) BMI was significant. Sperm motility improved in all three groups (P = .001, P = .02 and P = .003, respectively).
CONCLUSION


Weight loss can significantly increase semen volume, its concentration, its mobility and percentage of normal morphology. Consuming vitamin C significantly improves sperm concentration and mobility, but the semen volume and the percentage of normal morphology will not change significantly.",2016,"Sperm motility improved in all three groups (P = .001, P = .02 and P = .003, respectively).
","['Normal Obese Men', 'normal obese man', 'A total number of 200 men', '50 men with normal spermogram']","['intensive exercise program', 'Consuming vitamin C', 'Dietary Vitamin C and Exercise Interventions', 'vitamin C', 'dietary vitamin C and weight loss exercises interventions']","['Improving sperm motility', 'Weight loss', 'semen volume, its concentration, its mobility and percentage of normal morphology', 'sperm concentration and mobility', 'concentration of sperm per mL of semen in body mass index', 'Fertility Parameters', 'BMI', 'sperm concentration', 'Sperm motility']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0037848', 'cui_str': 'Sperm Motility'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C4048707', 'cui_str': 'Concentration of sperm'}, {'cui': 'C2756969', 'cui_str': 'Semen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",50.0,0.0627947,"Sperm motility improved in all three groups (P = .001, P = .02 and P = .003, respectively).
","[{'ForeName': 'Bahare', 'Initials': 'B', 'LastName': 'Rafiee', 'Affiliation': 'Pharmaceutical Sciences Research Center, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Morowvat', 'Affiliation': 'Pharmaceutical Sciences Research Center, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Rahimi-Ghalati', 'Affiliation': 'Bagherian Industrial School, Ministry of Education and Training, Shiraz, Iran.'}]",Urology journal,[]
881,27085566,"Prevention of Urinary Tract Infection with Oximacro, A Cranberry Extract with a High Content of A-Type Proanthocyanidins: A Pre-Clinical Double-Blind Controlled Study.","PURPOSE


Urinary tract infections (UTIs) are widespread and affect a large portion of the human population. Cranberry juices and extracts have been used for UTI prevention due to their content of bioactive proanthocyanidins (PACs), particularly of the A type (PAC-A). Controversial clinical results obtained with cranberry are often due to a lack of precise determination and authentication of the PAC-A content. This study used Oximacro (Biosfered S.r.l., Turin, Italy), a cranberry extract with a high content of PAC-A, to prevent UTIs in female and male volunteers.
MATERIALS AND METHODS


The Oximacro PACs content was assayed using the Brunswick Laboratories 4-dimethylaminocinnamaldehyde (BL-DMAC) method, and the dimer and trimer PACs-A and PACs-B percentages were determined via high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC/ESI-MS/MS). A balanced group of female (ranging from 19 to over 51 years) and male volunteers (over 51 years) was divided into two groups. The experimental group received 1 capsule containing Oximacro (36 mg PACs-A) twice per day (morning and evening) for 7 days, and the placebo group was given the same number of capsules with no PACs.
RESULTS


Analysis of Oximacro revealed a high total PAC content (372.34 mg/g ± 2.3) and a high percentage of PAC-A dimers and trimers (86.72% ± 1.65). After 7 days of Oximacro administration, a significant difference was found between the placebo and Oximacro groups for both females (Mann-Whitney U-test = 875; P < .001; n = 60) and males (Mann-Whitney U-test = 24; P = .016; n = 10). When the female and male age ranges were analysed separately, the female age range 31-35 showed only slightly significant differences between the placebo and Oximacro groups (Mann-Whitney U-test = 20.5; P = .095; n = 10), whereas all other female age ranges showed highly significant differences between the placebo and Oximacro groups (Mann-Whitney U-test = 25; P = .008; n = 10). Furthermore, colony forming unit/mL counts from the urine cultures showed a significant difference (P < .001) between the experimental and the placebo groups (SD difference = 51688; df = 34, t = -10.27; Dunn-Sidak Adjusted P < .001, Bonferroni Adjusted P < .001).
CONCLUSION


Careful determination of the total PAC content using the BL-DMAC method and the authentication of PACs-A with mass spectrometry in cranberry extracts are necessary to prepare effective doses for UTI prevention. A dose of 112 mg Oximacro containing 36 mg PACs-A was found to be effective in preventing UTIs when used twice per day for 7 days.",2016,"Furthermore, colony forming unit/mL counts from the urine cultures showed a significant difference (P < .001) between the experimental and the placebo groups (SD difference = 51688; df = 34, t = -10.27; Dunn-Sidak Adjusted P < .001, Bonferroni Adjusted P < .001).
","['A balanced group of female (ranging from 19 to over 51 years) and male volunteers (over 51 years', 'female and male volunteers']","['1 capsule containing Oximacro', 'Oximacro, A Cranberry Extract with a High Content of A-Type Proanthocyanidins', 'placebo', 'cranberry extract']","['Oximacro PACs content', 'high total PAC content']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0936050', 'cui_str': 'Cranberry'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0072018', 'cui_str': 'proanthocyanidin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.163796,"Furthermore, colony forming unit/mL counts from the urine cultures showed a significant difference (P < .001) between the experimental and the placebo groups (SD difference = 51688; df = 34, t = -10.27; Dunn-Sidak Adjusted P < .001, Bonferroni Adjusted P < .001).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Occhipinti', 'Affiliation': 'Department of Life Sciences and Systems Biology, University of Turin, Via Quarello 15/A, Turin, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Germano', 'Affiliation': 'Farmacia Antoniana, Viale Cesare Balbo, 3, 10040 San Gillio (TO), Italy.'}, {'ForeName': 'Massimo E', 'Initials': 'ME', 'LastName': 'Maffei', 'Affiliation': 'Department of Life Sciences and Systems Biology, University of Turin, Via Quarello 15/A, Turin, Italy.'}]",Urology journal,[]
882,26811126,Drinkers' memory bias for alcohol picture cues in explicit and implicit memory tasks.,"BACKGROUND


Alcohol cues can bias attention and elicit emotional reactions, especially in drinkers. Yet, little is known about how alcohol cues affect explicit and implicit memory processes, and how memory for alcohol cues is affected by acute alcohol intoxication.
METHODS


Young adult participants (N=161) were randomly assigned to alcohol, placebo, or control beverage conditions. Following beverage consumption, they were shown neutral, emotional and alcohol-related pictures cues. Participants then completed free recall and repetition priming tasks to test explicit and implicit memory, respectively, for picture cues. Average blood alcohol concentration for the alcohol group was 74±13mg/dl when memory testing began. Two mixed linear model analyses were conducted to examine the effects of beverage condition, picture cue type, and their interaction on explicit and implicit memory.
RESULTS


Picture cue type and beverage condition each significantly affected explicit recall of picture cues, whereas only picture cue type significantly influenced repetition priming. Individuals in the alcohol condition recalled significantly fewer pictures than those in other conditions, regardless of cue type. Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues. No interaction effects were detected.
CONCLUSIONS


Young adult drinkers showed enhanced explicit and implicit memory processing of alcohol cues compared to emotionally neutral cues. This enhanced processing for alcohol cues was on par with that seen for positive emotional cues. Acute alcohol intoxication did not alter this preferential memory processing for alcohol cues over neutral cues.",2016,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"['Young adult drinkers', 'Young adult participants (N=161']","['alcohol, placebo, or control beverage conditions']","['enhanced explicit and implicit memory processing of alcohol cues', 'explicit recall of picture cues', 'Average blood alcohol concentration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",161.0,0.0200569,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"[{'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: ttn045@ucsd.edu.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: jbuckman@rutgers.edu.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: shmita@rci.rutgers.edu.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: mebates@rutgers.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2015.12.033']
883,26571315,Diagnostic Yield and Complications Using a 20 Gauge Prostate Biopsy Needle versus a Standard 18 Gauge Needle: A Randomized Controlled Study.,"PURPOSE


To compare and evaluate whether a 20 gauge (20G) biopsy needle maintains a similar detection rate as that of the commonly used 18G needle for transrectal ultrasound-guided prostate biopsy (TRUSPB) aimed at assessing prostate cancer (PCa) and decreasing pain and complications.
MATERIALS AND METHODS


A total of 122 cases with indications of PCa were randomly allocated into two groups for this randomized controlled study. TRUSPB was performed randomly using either an 18G or 20G needle for core biopsies (62 cases with 18G and 60 cases with 20G). Detection rate, pain, and complications were assessed after the procedure.
RESULTS


The cancer detection rate in the 18G group (40.3%) did not differ from that in the 20G group (35.0%). However, the number of patients with pain was significantly lower in 20G group (P < 0.05). The number of patients with self-limiting hematuria decreased in both groups after the biopsy procedure (18G: 38 cases; 20G: 16 cases; P < .0001). Hematochezia occurred in 11 cases (9 cases [14.5%] in the 18G group; 2 cases [3.4%] in the 20G group). The number of patients with infection, dysuria, and urinary retention tended to be lower in 20G group.
CONCLUSION


Use of a 20G needle for TRUSPB yielded a comparable cancer detection rate to that of an 18G needle and led to less local injury, pain, and complications. A larger and more sensitive study is needed to verify our results.",2015,The cancer detection rate in the 18G group (40.3%) did not differ from that in the 20G group (35.0%).,['122 cases with indications of PCa'],"['20 Gauge Prostate Biopsy Needle versus a Standard 18 Gauge Needle', 'TRUSPB', '20 gauge (20G) biopsy needle', 'transrectal ultrasound-guided prostate biopsy (TRUSPB']","['Hematochezia', 'cancer detection rate', 'number of patients with self-limiting hematuria', 'Detection rate, pain, and complications', 'local injury, pain, and complications', 'number of patients with pain', 'Diagnostic Yield and Complications', 'number of patients with infection, dysuria, and urinary retention']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C3878906', 'cui_str': 'Prostate biopsy needle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0181960', 'cui_str': 'Biopsy needle, device (physical object)'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",122.0,0.0245237,The cancer detection rate in the 18G group (40.3%) did not differ from that in the 20G group (35.0%).,"[{'ForeName': 'Jianlong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Wan', 'Affiliation': 'Department of Urology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Tongji Hospital, Shanghai, China.'}, {'ForeName': 'Jianye', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, China.""}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Wake Forest Institute for Regenerative Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kaile', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Tongji Hospital, Shanghai, China.'}]",Urology journal,[]
884,26571321,980-Nm Diode Laser Vaporization versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: Randomized Controlled Study.,"PURPOSE


We compared the effectiveness and complications of 980-nm diode laser vaporization and transurethral resection of the prostate (TURP) in patients with benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


In total, 72 consecutive patients with BPH entered the study. All patients underwent general and urological evaluations. The primary outcome was improvement in the International Prostate Symptom Score (IPSS). The secondary outcomes were IPSS quality of life (QoL), maximum urinary flow rate (Qmax), residual volume, and complications. Patients were allocated randomly to the TURP and laser groups. The Ceralas HPD120, a diode laser system emitting at a wavelength of 980 nm, was used for photoselective vaporization of the prostate (PVP). TURP was performed with a monopolar 26 French resectoscope. Preoperative and operative parameters and surgical outcomes were compared.
RESULTS


In total, 36 patients in each group underwent PVP and TURP. The mean age ± standard deviation was 63.1 ± 9.1 years and 64.7 ± 10.2 years in the PVP and TURP groups, respectively. There were no statistically significant differences in age, prostate size, prostate-specific antigen concentration, Qmax, preoperative IPSS, or preoperative Qmax between the two groups. The operation duration was also similar between the groups (P = .36). The catheterization time was 1.45 ± 0.75 and 2.63 ± 0.49 days in the PVP and TURP groups, respectively (P < .01). The PVP group had a shorter hospital stay than the TURP group. The 3-month postoperative Qmax increased to 9.90 ± 3.61 and 6.59 ± 6.06 mL/s from baseline in the TURP and PVP groups, respectively; there was no difference in the increases between the groups (P = .08). The IPSS and IPSS-QoL were significantly improved with the operation (P < .01), and this improvement was similar in both groups P = .3 and P = .8, respectively . The complication rate was also similar between the two groups.
CONCLUSIONS


PVP with a diode laser is as safe and effective as TURP in the treatment of BPH, and the techniques have similar complication rates and functional results. PVP has the advantage of shorter hospitalization and catheter indwelling times and no need for discontinuation of anticoagulant therapy.",2015,"There were no statistically significant differences in age, prostate size, prostate-specific antigen concentration, Qmax, preoperative IPSS, or preoperative Qmax between the two groups.","['Benign Prostatic Hyperplasia', 'The mean age ± standard deviation was 63.1 ± 9.1 years and 64.7 ± 10.2 years in the PVP and TURP groups, respectively', 'All patients underwent general and urological evaluations', '72 consecutive patients with BPH entered the study', 'patients with benign prostatic hyperplasia (BPH']","['980-Nm Diode Laser Vaporization versus Transurethral Resection', '980-nm diode laser vaporization and transurethral resection of the prostate (TURP', 'PVP with a diode laser', 'PVP', 'PVP and TURP', 'TURP']","['3-month postoperative Qmax', 'IPSS quality of life (QoL), maximum urinary flow rate (Qmax), residual volume, and complications', 'operation duration', 'catheterization time', 'age, prostate size, prostate-specific antigen concentration, Qmax, preoperative IPSS, or preoperative Qmax', 'IPSS and IPSS-QoL', 'International Prostate Symptom Score (IPSS', 'complication rate', 'shorter hospital stay']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034380'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate (observable entity)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",72.0,0.0289914,"There were no statistically significant differences in age, prostate size, prostate-specific antigen concentration, Qmax, preoperative IPSS, or preoperative Qmax between the two groups.","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Cetinkaya', 'Affiliation': 'Department of Urology, School of Medicine, Mugla Sitki Kocman University, Mugla, Turkey. drmemoly@yahoo.com.'}, {'ForeName': 'Kadir', 'Initials': 'K', 'LastName': 'Onem', 'Affiliation': 'Department of Urology, Ondokuz Mayis Medical Faculty, Ondokuz Mayis University, Samsun, Turkey.'}, {'ForeName': 'Mehmet Murat', 'Initials': 'MM', 'LastName': 'Rifaioglu', 'Affiliation': 'Department of Urology, Medical Faculty, Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Veli', 'Initials': 'V', 'LastName': 'Yalcin', 'Affiliation': 'Department of Urology, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey.'}]",Urology journal,[]
885,26945662,"Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods.","PURPOSE


To evaluate the effects of two preoperative treatment courses with Finasteride on intraoperative and postoperative bleeding complications and prostate blood vessel characteristics in men who underwent transurethral resection of prostate (TURP) using monopolar energy.
MATERIALS AND METHODS


Men scheduled for TURP were randomized into group 1 (control n = 25, no medication), group 2 and 3 (n = 20 in each, 5 mg Finasteride daily for 2 and 4 weeks before TURP; respectively). Hematocrit level in the irrigation fluid, weight of the resected prostate chips, decreases in blood hemoglobin (Hb) level 6 and 24 hours after the operation together with volume and length density of prostate vessels using stereological methods were compared.
RESULTS


The three groups were matched regarding preoperative demographic data, resection time and weight of the resected tissue. Men who received preoperative Finasteride (groups 2 and 3) had significantly lower hematocrit levels in irrigation fluid than control group (control, 0.59 ± 0.85, group 2, 0.25 ± 0.4, group 3, 0.175 ± 0.16; P = .028; Power = .80). However, no statistically significant difference was found in hematocrit level in irrigation fluid between groups 2 and 3 (0.25 ± 0.4 vs. 0.175 ± 0.16, 95% confidence interval (CI) = -0.28-0.42; P = .68). These values were independent of the weight of the resected tissue and resection time. There were no significant differences between the three groups in the decrease in Hb 6 hours (P = .58) and 24 hours after TURP (P = .65). The stereological and histological characteristics of blood vessels in suburethral prostate tissue were similar in all three groups.
CONCLUSION


A 2-week preoperative course of daily Finasteride seems sufficient to significantly reduce intraoperative blood loss; this effect was independent of the weight of the resected tissue and resection time. Neither the 2-week nor the 4-week presurgical Finasteride regimen could significantly decrease postoperative blood loss, and neither regimen induced significant changes in characteristics of prostate tissue blood vessels.",2016,"Neither the 2-week nor the 4-week presurgical Finasteride regimen could significantly decrease postoperative blood loss, and neither regimen induced significant changes in characteristics of prostate tissue blood vessels.","['Men scheduled for TURP', 'men who underwent']","['transurethral resection of prostate (TURP', 'preoperative Finasteride', 'Finasteride', 'Preoperative Finasteride', 'Monopolar Transurethral Resection of Prostate']","['weight of the resected tissue and resection time', 'Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss', 'postoperative blood loss', 'hematocrit levels in irrigation fluid', 'hematocrit level in irrigation fluid', 'intraoperative blood loss', 'characteristics of prostate tissue blood vessels', 'preoperative demographic data, resection time and weight of the resected tissue', 'Hematocrit level', 'blood hemoglobin (Hb) level']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0005847', 'cui_str': 'Blood Vessel'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0262159,"Neither the 2-week nor the 4-week presurgical Finasteride regimen could significantly decrease postoperative blood loss, and neither regimen induced significant changes in characteristics of prostate tissue blood vessels.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Aminsharifi', 'Affiliation': 'Department of Urology, Shiraz University of Medical Sciences, Shiraz, Iran. aminsharifi_ar@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Department of Epidemiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Noorafshan', 'Affiliation': 'Department of Histomorphometry and Stereology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Aminsharifi', 'Affiliation': 'General Internal Medicine, Toronto General Hospital, Toronto, Canada.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Alnajar', 'Affiliation': 'Department of Urology, Shiraz University of Medical Sciences, Shiraz, Iran. aminsharifi_ar@yahoo.com.'}]",Urology journal,[]
886,24595939,Success rate and patients' satisfaction following intradetrusor dysport injection in patients with detrusor overactivity: a comparative study of idiopathic and neurogenic types of detrusor overactivity.,"PURPOSE


To evaluate the efficacy of intradetrusor Dysport (a type of botulinum toxin type A) injection in patients with idiopathic or neurogenic detrusor overactivity, who were refractory to antimuscarinic drugs, and to compare the efficacy of Dysport injection in both groups.
MATERIALS AND METHODS


Twelve patients with neurogenic detrusor overactivity (NDO) and 18 patients with idiopathic detrusor overactivity (IDO) participated in this study. All the patients received intravesical injection of 500 units of Dysport. They were followed up for 3 months after injection with maximum cystometric capacity, maximum detrusor filling pressure, and number of catheterization or pad usage.
RESULTS


After 3 months, the mean maximum cystometric capacity increased from 109.36 ± 24.11 mL to 266.81 ± 97.18 mL (P = .000) in the NDO group and from 192.24 ± 36.21 mL to 272.61 ± 63.37 mL (P = .000) in the IDO group. The mean maximum detrusor filling pressure decreased from 48.14 ± 26.51 cmH2O to 28.91 ± 9.01 cmH2O (P = .005) in the NDO group and from 39.22 ± 9.92 cmH2O to 29.64 ± 10.14 cmH2O (P = .003) in the IDO group.
CONCLUSION


Intradetrusor Dysport injection improved urodynamic parameters and quality of life (QoL) in both groups significantly. We did not find significant difference in QoL or urodynamic parameters between both groups.",2014,We did not find significant difference in QoL or urodynamic parameters between both groups.,"['Twelve patients with neurogenic detrusor overactivity (NDO) and 18 patients with idiopathic detrusor overactivity (IDO) participated in this study', 'patients with detrusor overactivity', 'patients with idiopathic or neurogenic detrusor overactivity, who were refractory to antimuscarinic drugs']","['intradetrusor Dysport', 'botulinum toxin type A) injection']","['maximum detrusor filling pressure, and number of catheterization or pad usage', 'mean maximum detrusor filling pressure', 'urodynamic parameters and quality of life (QoL', 'QoL or urodynamic parameters', 'mean maximum cystometric capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0591427', 'cui_str': 'Dysport'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0429809', 'cui_str': 'Maximum cystometric capacity (observable entity)'}]",12.0,0.0371964,We did not find significant difference in QoL or urodynamic parameters between both groups.,"[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shakeri', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadian', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Aminsharifi', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ariafar', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Vaghedashti', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Yazdani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Yadollahi', 'Affiliation': 'Trauma research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Emadmarvasti', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Baharikhoob', 'Affiliation': 'Urology and Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Urology journal,[]
887,26340282,"Return on Investment of a Work-Family Intervention: Evidence From the Work, Family, and Health Network.","OBJECTIVE


To estimate the return on investment (ROI) of a workplace initiative to reduce work-family conflict in a group-randomized 18-month field experiment in an information technology firm in the United States.
METHODS


Intervention resources were micro-costed; benefits included medical costs, productivity (presenteeism), and turnover. Regression models were used to estimate the ROI, and cluster-robust bootstrap was used to calculate its confidence interval.
RESULTS


For each participant, model-adjusted costs of the intervention were $690 and company savings were $1850 (2011 prices). The ROI was 1.68 (95% confidence interval, -8.85 to 9.47) and was robust in sensitivity analyses.
CONCLUSION


The positive ROI indicates that employers' investment in an intervention to reduce work-family conflict can enhance their business. Although this was the first study to present a confidence interval for the ROI, results are comparable with the literature.",2015,"The ROI was 1.68 (95% confidence interval, -8.85 to 9.47) and was robust in sensitivity analyses.
",[],[],"['medical costs, productivity (presenteeism), and turnover']",[],[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}]",,0.0292825,"The ROI was 1.68 (95% confidence interval, -8.85 to 9.47) and was robust in sensitivity analyses.
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barbosa', 'Affiliation': 'From the Behavioral Health Economics Program (Dr Barbosa), RTI International, Chicago, Ill; Department of Economics (Dr Bray), University of North Carolina at Greensboro; Behavioral Health Economics Program (Mr Dowd and Mr Mills), RTI International, Research Triangle Park, NC; Department of Sociology (Drs Moen and Kelly), University of Minnesota, Minneapolis; Oregon Institute of Occupational Health Sciences (Drs Wipfli and Olson); and Department of Public Health and Preventive Medicine (Dr Olson), Oregon Health & Science University, and Department of Psychology, Portland State University, Ore.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Bray', 'Affiliation': ''}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Dowd', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Moen', 'Affiliation': ''}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wipfli', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': ''}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Kelly', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000000520']
888,26341769,Comparison between Microsurgical Subinguinal Varicocelectomy with and without Testicular Delivery for Infertile Men: Is Testicular Delivery an Unnecessary Procedure.,"PURPOSE


Controversy still exists as to whether testicular delivery during microsurgical subinguinal varicocelecto­my (MSV) provides benefit to the patient or not. This study specifically compared the therapeutic effect of MSV with and without testicular delivery for the treatment of varicocele in a cohort of infertile men.
MATERIALS AND METHODS


We conducted a prospective, randomized, controlled study to evaluate the therapeutic efficacy of MSV with and without testicular delivery for the treatment of varicocele in infertile men. A total of 100 patients were specifically recruited using strict inclusion criteria to undergo MSV with testicular delivery (group 1, n = 50) or MSV without testicular delivery (group 2, n = 50). All patients were followed-up at 3, 6 and 12 months following surgery. Semen parameters, pregnancy and recurrence rates, and complications were monitored.
RESULTS


Mean surgical time for group 1 was significantly longer than group 2 (90.50 ± 15.60 min vs. 84.30 ± 15.58 min; P = .001). Sperm count and motility were significantly improved at the 12-month follow-up appoint­ment in both groups compared with pre-operative values, but were not significantly different at 3, 6, and 12 months when compared between the two treatment groups. The incidence of scrotal edema, and spermatic/testicular en­gorgement were higher in group 1 (both P = .001), although natural pregnancy rate was not significantly different between the two groups at the 12 month follow-up appointment (46% vs. 42%) (P = .817).
CONCLUSION


MSV with testicular delivery did not reduce the risk of recurrence and led to improved semen quality compared with MSV without testicular delivery. However, there was a higher risk of complication with this tech­nique, which must be borne in mind when considering the clinical implications of our dataset.",2015,"CONCLUSION


MSV with testicular delivery did not reduce the risk of recurrence and led to improved semen quality compared with MSV without testicular delivery.","['A total of 100 patients were specifically recruited using strict inclusion criteria to undergo MSV with testicular delivery (group 1, n = 50) or MSV without testicular delivery (group 2, n = 50', 'varicocele in a cohort of infertile men', 'varicocele in infertile men', 'Infertile Men']","['Microsurgical Subinguinal Varicocelectomy with and without Testicular Delivery', 'MSV with and without testicular delivery', 'microsurgical subinguinal varicocelecto\xadmy (MSV']","['natural pregnancy rate', 'risk of recurrence', 'incidence of scrotal edema, and spermatic/testicular en\xadgorgement', 'semen quality', 'Semen parameters, pregnancy and recurrence rates, and complications', 'Sperm count and motility', 'Mean surgical time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0560133', 'cui_str': 'mSv'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0194985', 'cui_str': 'Excision of varicocele (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0560133', 'cui_str': 'mSv'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0151609', 'cui_str': 'Edema of scrotum (disorder)'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0037842', 'cui_str': 'Sperm Count'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",100.0,0.0557626,"CONCLUSION


MSV with testicular delivery did not reduce the risk of recurrence and led to improved semen quality compared with MSV without testicular delivery.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, China and Japan union hospital of Jilin University, 126 Xiantai Street, Changchun City, Jilin province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, China and Japan union hospital of Jilin University, 126 Xiantai Street, Changchun City, Jilin province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, China and Japan union hospital of Jilin University, 126 Xiantai Street, Changchun City, Jilin province, China. 986062616@qq.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huo', 'Affiliation': 'Department of Urology, China and Japan union hospital of Jilin University, 126 Xiantai Street, Changchun City, Jilin province, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, China and Japan union hospital of Jilin University, 126 Xiantai Street, Changchun City, Jilin province, China.'}]",Urology journal,[]
889,32418143,"Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Dual antiplatelet therapy, aspirin and a P2Y 12  inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.
METHODS


This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix ®  (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel were calculated.
RESULTS


In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD W ) was at least 0.294 for acetylsalicylic acid C max , AUC last , and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
CONCLUSION


Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.
TRIAL REGISTRATION


CTR20181695.",2020,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","['171 healthy subjects', 'Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study', 'healthy Chinese subjects under fasting conditions', 'Chinese Subjects Under Fasting Conditions', 'healthy Chinese volunteers', 'Chinese male and female healthy volunteers']","['Clopidogrel plus acetylsalicylic acid combination', 'acetylsalicylic acid and 75\xa0mg clopidogrel', 'acetylsalicylic acid', 'acetylsalicylic acid and clopidogrel', 'aspirin', 'Clopidogrel Versus Enteric Aspirin', 'Co-Plavix ®  (test formulation- fixed-dose combination of 100\xa0mg acetylsalicylic acid and 75\xa0mg clopidogrel', 'Clopidogrel\u2009+\u2009acetylsalicylic acid']","['Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel', 'geometric mean ratios of clopidogrel C max , AUC last , and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0504812,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China. jie.hou@estartpoc.com.'}]",Advances in therapy,['10.1007/s12325-020-01369-z']
890,31121249,Harms From Haloperidol for Symptom Management in Palliative Care-a Post Hoc Pooled Analysis of Three Randomized Controlled Studies and Two Consecutive Cohort Studies.,,2019,,[],['Haloperidol'],[],[],"[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}]",[],,0.0826825,,"[{'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan; Palliative Care Center, Cancer Center, Kindai University Hospital, Osaka, Japan; Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Zac', 'Initials': 'Z', 'LastName': 'Vandersman', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Good', 'Affiliation': ""St Vincent's Private Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Department of Palliative and Supportive Care, Mater Health Services and Mater Research Institute, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Weil', 'Affiliation': ""Department of Palliative Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, NSW, Australia. Electronic address: david.currow@uts.edu.au.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.05.004']
891,25421470,Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.,"The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 patients between the ages of 4 months and <17 years were obtained from four phase I and two phase III clinical trials. Population pharmacokinetic models were used to simulate the proportion of children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml. Simulated pediatric dosages of 0.5 to 5 mg/kg of body weight/day were explored. A two-compartment model was used that incorporated body weight as a predefined covariate for allometric scaling of the pharmacokinetic parameters. During construction of the model, aspartate aminotransferase and total bilirubin were also identified as covariates that had a significant effect on micafungin clearance. A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis. Cutoffs of 40 or 50 kg for weight-based dosing resulted in heavier children being appropriately dosed. Thus, dose regimens of 1, 2, and 3 mg/kg/day micafungin are appropriate for the prevention of invasive candidiasis, the treatment of invasive candidiasis, and the treatment of esophageal candidiasis, respectively, in children aged 4 months to <17 years.",2015,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"['children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml', 'children and adolescents', 'children aged 4 months to <17 years', 'adults', '229 patients between the ages of 4 months and <17 years were obtained from four phase']",[],"['aspartate aminotransferase and total bilirubin', 'micafungin clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",229.0,0.0417469,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Division of Infectious Disease, Orange, California, USA.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Azie', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Kovanda', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.03736-14']
892,31851385,Efficacy and safety of tailored and dose-dense adjuvant chemotherapy and trastuzumab for resected HER2-positive breast cancer: Results from the phase 3 PANTHER trial.,"BACKGROUND


Dose-dense (DD) adjuvant chemotherapy improves outcomes in early breast cancer (BC). However, there are no phase 3 randomized data to inform on its combination with trastuzumab for patients with human epidermal growth factor receptor 2 (HER2)-positive disease.
METHODS


This was a protocol-predefined secondary analysis of the randomized phase 3 Pan-European Tailored Chemotherapy (PANTHER) trial. Women 65 years old or younger with node-positive or high-risk, node-negative BC were randomized 1:1 to either tailored (according to hematologic nadirs) and DD epirubicin and cyclophosphamide followed by docetaxel or standard 5-fluorouracil, epirubicin, and cyclophosphamide plus docetaxel every 3 weeks. Patients with HER2-positive disease received 1 year of adjuvant trastuzumab. The primary endpoint was BC relapse-free survival. In addition, HER2-positive patients and an equal number of HER2-negative patients matched for age, treatment group, and institution who were enrolled at Swedish sites were asked to participate in a predefined study of cardiac safety and underwent echocardiography or multigated acquisition scanning and electrocardiography at the baseline and at 4 and 6 years of follow-up.
RESULTS


There were 342 HER2-positive patients; 335 received at least 1 dose of trastuzumab, and 29 patients discontinued trastuzumab prematurely. Relapse-free survival was not statistically significantly in favor of the tailored and DD group (hazard ratio, 0.68; 95% confidence interval, 0.37-1.27; P = .231). Cardiac outcomes after 4 and 6 years of follow-up did not differ significantly between HER2-positive and HER2-negative patients or between the 2 treatment groups.
CONCLUSIONS


The combination of DD chemotherapy and trastuzumab decreased the relative risk for relapse by 32% in comparison with standard treatment, a statistically nonsignificant difference. Its efficacy and safety merit further evaluation as part of both escalation and de-escalation strategies.",2020,"Relapse-free survival was not statistically significantly in favor of the tailored and DD group (hazard ratio, 0.68; 95% confidence interval, 0.37-1.27;","['342 HER2-positive patients; 335 received at least 1 dose of trastuzumab, and 29 patients discontinued trastuzumab prematurely', 'Resected HER2-Positive Breast Cancer', 'early breast cancer (BC', 'HER2-positive patients and an equal number of HER2-negative patients matched for age, treatment group, and institution who were enrolled at Swedish sites', 'Patients with HER2-positive disease', 'patients with human epidermal growth factor receptor 2 (HER2)-positive disease', 'Women 65\xa0years old or younger with node-positive or high-risk, node-negative BC']","['Tailored and Dose-Dense Adjuvant Chemotherapy and Trastuzumab', 'DD epirubicin and cyclophosphamide followed by docetaxel or standard 5-fluorouracil, epirubicin, and cyclophosphamide plus docetaxel', 'adjuvant trastuzumab', 'Dose-dense (DD) adjuvant chemotherapy', 'echocardiography or multigated acquisition scanning and electrocardiography at the baseline and at 4 and 6\xa0years of follow-up', 'trastuzumab', 'DD chemotherapy and trastuzumab']","['Relapse-free survival', 'Cardiac outcomes', 'relative risk for relapse', 'BC relapse-free survival', 'Efficacy and Safety']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",342.0,0.133798,"Relapse-free survival was not statistically significantly in favor of the tailored and DD group (hazard ratio, 0.68; 95% confidence interval, 0.37-1.27;","[{'ForeName': 'Antroula', 'Initials': 'A', 'LastName': 'Papakonstantinou', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Matikas', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Nils Olof', 'Initials': 'NO', 'LastName': 'Bengtsson', 'Affiliation': 'University Hospital Umeå, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hedayati', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Steger', 'Affiliation': 'Medical Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Obstetrics and Gynecology, Helios Hospital Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Hübbert', 'Affiliation': 'Department of Medical and Health Sciences, Division of Cardiovascular Medicine, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Third Medical Department, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Moebus', 'Affiliation': 'Department of Medicine II, Hematology & Oncology, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.'}]",Cancer,['10.1002/cncr.32653']
893,32417961,Postoperative morbidity after adenotonsillectomy versus adenopharyngoplasty in young children with obstructive sleep apnea: an RCT.,"PURPOSE


In our previous randomized controlled trial (RCT), comparing adenotonsillectomy (ATE) with adenopharyngoplasty (APP) in children with severe obstructive sleep apnea (OSA), there were no differences in respiratory sleep parameters or quality of life. The purpose of the present report was to evaluate postoperative morbidity from this RCT.
METHODS


The study was a blinded RCT in 83 children (ATE = 47; APP = 36), 2-4 years of age, with an obstructive apnea-hypopnea index of ≥ 10. Pain was assessed from the first until the tenth day after surgery with a logbook that reported pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change. Bleeding, infection, satisfaction with treatment, speech, and swallowing were assessed with a questionnaire and medical records 6 months after surgery.
RESULTS


Sixty-four children (77%) returned the logbook and 65 (78%) answered the questionnaire. The median (interquartile range) day the children graded themselves as pain free (FPS-R = 0) was 7 (6-10) after ATE, compared with 9 (7 to > 10) after APP (p = 0.018). There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
CONCLUSION


The results regarding postoperative morbidity were in favor of ATE and the results from our previous report showed no advantages of APP. Therefore, APP should not be recommended in young, otherwise healthy children with OSA.",2020,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","['83 children (ATE\u2009=\u200947; APP\u2009=\u200936), 2-4\xa0years of age, with an obstructive apnea-hypopnea index of\u2009≥\u200910', 'healthy children with OSA', 'young children with obstructive sleep apnea', 'children with severe obstructive sleep apnea (OSA']","['adenotonsillectomy versus adenopharyngoplasty', 'adenotonsillectomy (ATE) with adenopharyngoplasty (APP']","['respiratory sleep parameters or quality of life', 'Pain', 'pain free', 'postoperative morbidity', 'pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech', 'Postoperative morbidity', 'impaired speech after APP', 'pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change', 'Bleeding, infection, satisfaction with treatment, speech, and swallowing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0233715', 'cui_str': 'Disturbance in speech'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.0413008,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden. johan.fehrm@sll.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borgström', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06035-2']
894,31092125,Model Simulations Challenge Reductionist Research Approaches to Studying Chronic Low Back Pain.,"BACKGROUND


Traditionally, low back pain (LBP) is studied using a reductionist approach, in which the factors contributing to the clinical presentation of LBP are studied in isolation to identify the primary pathology or condition linked to LBP. We argue that reductionism may not be suitable for studying LBP, considering the complex, multifactorial nature of this condition.
OBJECTIVES


To quantify the likelihood of successfully subclassifying patients with LBP and effectively targeting treatment based on a single dominant factor contributing to LBP.
METHODS


Both analytical and numerical simulations (Monte Carlo) of 1 million patients with LBP were performed. Several factors contributing to LBP were randomly assigned to each individual. The following outcome measures were computed, as a function of the number of factors: the percentage of individuals who could be subclassified by identifying a single factor exceeding a certain threshold, and the average reduction in LBP when treatment eliminates the largest contributing factor versus a multimodal treatment that eliminates a number of the randomly selected factors.
RESULTS


With an increasing number of factors, the probability of subclassifying an individual to a subgroup based on a single factor tends toward zero. A multimodal treatment arbitrarily addressing any 2 or more factors was more effective than diagnosing and treating a single factor that maximally contributed to LBP.
CONCLUSION


Results suggest that reductionism is not appropriate for subclassifying patients with LBP or for targeting treatment. The use of reductionist approaches may explain some of the challenges when creating LBP classification systems and designing effective treatment interventions.  J Orthop Sports Phys Ther 2019;49(6):477-481. Epub 15 May 2019. doi:10.2519/jospt.2019.8791 .",2019,"RESULTS


With an increasing number of factors",['1 million patients with LBP'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],0.0,0.0243796,"RESULTS


With an increasing number of factors","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Cholewicki', 'Affiliation': ''}, {'ForeName': 'Pramod K', 'Initials': 'PK', 'LastName': 'Pathak', 'Affiliation': ''}, {'ForeName': 'N Peter', 'Initials': 'NP', 'LastName': 'Reeves', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Popovich', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8791']
895,25703911,Novel approach for pain control in patients undergoing prostate biopsy: iliohypogastric nerve block with or without topical application of prilocaine-lidocaine: a randomized controlled trial.,"PURPOSE


To investigate the efficacy of a novel anesthetic technique called iliohypogastric nerve block (INB) for pain control in patients undergoing prostate biopsy.
MATERIALS AND METHODS


A total of 59 consecutive patients who underwent transrectal ultrasound guided prostates biopsies were included in the study. Patients were randomized into four groups: (1) control, no method of anesthesia was administered, (2) intrarectal prilocaine-lidocaine cream application, (3) INB and (4) INB + intrarectal prilocaine-lidocaine cream application (combined group). Patients were asked to use a scale of 0-10 in a Visual Analogue Scale (VAS) questionnaire about pain during probe insertion (VAS 1) and prostate biopsy (VAS 2).
RESULTS


The mean VAS 1 and VAS 2 scores were 0.7 and 4.9 for controls, 0.5 and 1.8 for INB, 0.5 and 2.6 for the intrarectal cream group, and 0.4 and 1.8 for the combined group. The mean VAS 1 scores were not different between groups. However, the mean VAS 2 scores were significantly lower in INB, prilocaine-lidocaine cream and combined groups compared to the control group (P &lt; .001). In addition, the INB group had significantly lower VAS 2 scores compared to the cream application group (P = .03). On the other hand, there was no difference between the INB and combined groups (P = .8).
CONCLUSION


Any form of anesthesia was superior to none. However, INB alone seemed to be superior to prilocaine-lidocaine cream application in patients undergoing prostate biopsy. Addition of prilocaine-lidocaine cream application to INB may not provide better analgesia.&nbsp;",2015,"However, the mean VAS 2 scores were significantly lower in INB, prilocaine-lidocaine cream and combined groups compared to the control group (P &lt; .001).","['patients undergoing prostate biopsy', '59 consecutive patients who underwent']","['transrectal ultrasound guided prostates biopsies', 'novel anesthetic technique called iliohypogastric nerve block (INB', 'prilocaine-lidocaine', 'prilocaine-lidocaine cream application, (3) INB and (4) INB + intrarectal prilocaine-lidocaine cream application', 'prilocaine-lidocaine cream', 'prilocaine-lidocaine cream application']","['mean VAS 1 scores', 'mean VAS 1 and VAS 2 scores', 'VAS 2 scores', 'mean VAS 2 scores', 'Visual Analogue Scale (VAS) questionnaire about pain during probe insertion (VAS 1) and prostate biopsy (VAS 2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve (procedure)'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0148052', 'cui_str': 'VA 2'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",59.0,0.0273349,"However, the mean VAS 2 scores were significantly lower in INB, prilocaine-lidocaine cream and combined groups compared to the control group (P &lt; .001).","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Hizli', 'Affiliation': 'Department of Urology, Oncology Training and Research Hospital, 06530 Demetevler, Ankara, Turkey. fatihhizli33@yahoo.com.'}, {'ForeName': 'Güldeniz', 'Initials': 'G', 'LastName': 'Argun', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Özkul', 'Affiliation': ''}, {'ForeName': 'Oguz', 'Initials': 'O', 'LastName': 'Güven', 'Affiliation': ''}, {'ForeName': 'Ali Ihsan', 'Initials': 'AI', 'LastName': 'Arik', 'Affiliation': ''}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Başay', 'Affiliation': ''}, {'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Köşüş', 'Affiliation': ''}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Günaydin', 'Affiliation': ''}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Başar', 'Affiliation': ''}]",Urology journal,[]
896,1670445,Thromboprophylaxis by low-molecular-weight heparin in elective hip surgery. A placebo controlled study.,"In a double-blind, randomised study of thromboprophylaxis in patients undergoing total hip replacement, we compared a low-molecular-weight heparin with a placebo. Of the 120 patients enrolled, 112 completed the trial; 58 in the treatment group and 54 in the placebo group. Nine (16%) patients in the treatment group and 19 (35%) in the placebo group developed deep venous thrombosis, diagnosed by the 125I-fibrinogen uptake test (p < 0.02). Verification was obtained by phlebography in 86% of the patients. Prolonged surgery increased the risk of thrombosis in the placebo group but not in the treatment group (p < 0.05). There were significantly more cases of deep venous thrombosis in the placebo group during the first four postoperative days (p < 0.02). The groups did not differ with respect to peroperative and postoperative bleeding. Low-molecular-weight heparin offers safe and easily administered thromboprophylaxis in total hip replacement.",1991,Prolonged surgery increased the risk of thrombosis in the placebo group but not in the treatment group (p < 0.05).,"['total hip replacement', '120 patients enrolled, 112 completed the trial; 58 in the treatment group and 54 in the placebo group', 'elective hip surgery', 'patients undergoing total hip replacement']","['placebo', 'thromboprophylaxis']","['risk of thrombosis', 'peroperative and postoperative bleeding', 'deep venous thrombosis']","[{'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",120.0,0.209402,Prolonged surgery increased the risk of thrombosis in the placebo group but not in the treatment group (p < 0.05).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tørholm', 'Affiliation': 'Department of Orthopaedics, University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Broeng', 'Affiliation': ''}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jørgensen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bjerregaard', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Josephsen', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Jørgensen', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': ''}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Knudsen', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
897,25975386,"The effects of ibudilast, a glial activation inhibitor, on opioid withdrawal symptoms in opioid-dependent volunteers.","Glial activation is hypothesized to contribute directly to opioid withdrawal. This study investigated the dose-dependent effects of a glial cell modulator, ibudilast, on withdrawal symptoms in opioid-dependent volunteers after abrupt discontinuation of morphine administration. Non-treatment-seeking heroin-dependent volunteers (n = 31) completed the in-patient, double-blind, placebo-controlled, within-subject and between-group study. Volunteers were maintained on morphine (30 mg, QID) for 14 days and placebo (0 mg, QID) for the last 7 days of the 3-week study. Volunteers also received placebo (0 mg, PO, BID) capsules on days 1-7. On days 8-21, volunteers were randomized to receive ibudilast (20 or 40 mg, PO, BID) or placebo capsules. Subjective and clinical ratings of withdrawal symptoms were completed daily using daily using the Subjective Opioid Withdrawal Scale (SOWS) and Clinical Opioid Withdrawal Scale (COWS). Medication side effects were also monitored. Relative to the first 2 weeks, all groups exhibited withdrawal during the third week as assessed by the SOWS and COWS (P ≤ 0.0001). Although overall SOWS scores did not differ between groups, exploratory analyses pooling the two ibudilast groups demonstrated that they had lower ratings of withdrawal symptoms on SOWS items ('anxious,' 'perspiring,' 'restless,' 'stomach cramps') during detoxification relative to the placebo group. Ibudilast was well tolerated; no serious adverse events occurred during the study. Pharmacological modulation of glial activity with ibudilast decreased some subjective ratings of opioid withdrawal symptoms. These exploratory findings are the first to demonstrate the potential clinical utility of glial modulators for treating opioid withdrawal in humans.",2016,"Relative to the first 2 weeks, all groups exhibited withdrawal during the third week as assessed by the SOWS and COWS (P ≤ 0.0001).","['Non-treatment-seeking heroin-dependent volunteers (n\u2009=\u200931', 'opioid-dependent volunteers', 'opioid-dependent volunteers after abrupt discontinuation of morphine administration']","['morphine', 'placebo', 'placebo capsules']","['Medication side effects', 'overall SOWS scores', 'Subjective Opioid Withdrawal Scale (SOWS) and Clinical Opioid Withdrawal Scale (COWS', 'Subjective and clinical ratings of withdrawal symptoms', 'tolerated; no serious adverse events', ""ratings of withdrawal symptoms on SOWS items ('anxious,' 'perspiring,' 'restless,' 'stomach cramps""]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2364092', 'cui_str': 'Medication side effects present'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0344375', 'cui_str': 'Stomach cramps (finding)'}]",,0.0953507,"Relative to the first 2 weeks, all groups exhibited withdrawal during the third week as assessed by the SOWS and COWS (P ≤ 0.0001).","[{'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Kirk W', 'Initials': 'KW', 'LastName': 'Johnson', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glass', 'Affiliation': 'Division of Biostatistics, New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Vosburg', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Manubay', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Saccone', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Abuse, New York Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}]",Addiction biology,['10.1111/adb.12261']
898,25194079,Combination of sacral neuromodulation and tolterodine for treatment of idiopathic overactive bladder in women: a clinical trial.,"PURPOSE


To evaluate the efficacy of intermittent percutaneous needle sacral nerve stimulation (IPN-SNS) in women with idiopathic overactive bladder (IOAB) treated with tolterodine.
MATERIALS AND METHODS


A total of 240 female patients diagnosed with IOAB were randomized to receive tolterodine only treatment (group 1, n = 120) or tolterodine combined with IPN-SNS (group 2, n = 120). Each group included 120 participants, who were divided into subgroups depending on whether they had dry OAB (urinary frequency and urgency) or wet OAB (urinary frequency and urgency with urgency incontinence). In the treatment group, patients received percutaneous IPN-SNS plus tolterodine (2 mg once daily), while in the control group, only tolterodine (2 mg once daily) was administered for 3 months. The voiding diary and urodynamic parameters were monitored, and patients' psychological depression and anxiety scores were recorded before and after treatment.
RESULTS


There were significantly greater improvements in the conditions of first desire to void (FDV), max­imum cystometric capacity (MCC), and daily average volumes, as well as the daily single maximum voided volumes in group 2 (P = .001) than in group 1. In addition, there were significantly greater decreases in self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores in group 2 compared with group 1 (P < .001).
CONCLUSION


Combined treatment with tolterodine plus IPN-SNS can not only improve the symptoms of voiding dysfunction but can also reduce the concomitant depression and anxiety in women with IOAB, there­by improving patients' quality of life.",2014,"In addition, there were significantly greater decreases in self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores in group 2 compared with group 1 (P < .001).
","['120 participants, who were divided into subgroups depending on whether they had dry OAB (urinary frequency and urgency) or wet OAB (urinary frequency and urgency with urgency incontinence', '240 female patients diagnosed with IOAB', 'idiopathic overactive bladder in women', 'women with idiopathic overactive bladder (IOAB) treated with tolterodine']","['tolterodine combined with IPN-SNS', 'percutaneous IPN-SNS plus tolterodine', 'intermittent percutaneous needle sacral nerve stimulation (IPN-SNS', 'tolterodine plus IPN-SNS', 'sacral neuromodulation and tolterodine', 'tolterodine']","['conditions of first desire to void (FDV), max\xadimum cystometric capacity (MCC), and daily average volumes, as well as the daily single maximum voided volumes', 'symptoms of voiding dysfunction', 'voiding diary and urodynamic parameters', 'psychological depression and anxiety scores', 'self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}]","[{'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C2609267', 'cui_str': 'Sacral nerve stimulation'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0429826', 'cui_str': 'Dysfunctional voiding of urine (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}]",240.0,0.0492577,"In addition, there were significantly greater decreases in self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores in group 2 compared with group 1 (P < .001).
","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China. tanghuaBM@163.com.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China.""}, {'ForeName': 'Yongfu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China.""}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China.""}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Urinary Surgery, The Second Hospital of Sanming, Yong'an, 366000, Fujian Province, China.""}]",Urology journal,[]
899,25194085,A prospective interventional study in chronic prostatitis with emphasis to clinical features.,"PURPOSE


Chronic bacterial prostatitis displays a variety of symptoms (mainly local pain exhibiting vari­ability in origin and intensity). These symptoms often persist despite bacterial eradication. The purpose of this article is to exam the role of phytotherapeutic agents as complementary treatment in patients with bacterial prostatitis.
MATERIALS AND METHODS


The material consisted of individuals with reported pelvic discomfort and genital pain with or without lower urinary tract symptoms (LUTS) and sexual dysfunction visiting our department from March 2009 to March 2011. Patients underwent Stamey-Meares test (several cases underwent the two glass test). Depending on history and specific symptoms urethral smear and semen cultures were additionally obtained from several patients. All patients were randomized into two groups. Subjects in the first group (72 patients) received appropriate antibiotic (according to the sensitivity test) for 15 days, while subjects in the second group (72 patients) received phytotherapeutic agents for 30 days, additionally the conventional 15 days antibiotic treatment. The response was tested using laboratory and clinical criteria.
RESULTS


We found no statistically significant differences between the two groups regarding bacterial and symptom persistence rate, however, symptoms burden was lower in patients receiving combinational treatment.
CONCLUSION


Phytotherapeutic agents may improve pain and prostatitis related difficulty in urination. Further randomized, placebo-controlled studies are needed to substantiate safer conclusions.",2014,"We found no statistically significant differences between the two groups regarding bacterial and symptom persistence rate, however, symptoms burden was lower in patients receiving combinational treatment.
","['patients with bacterial prostatitis', 'individuals with reported pelvic discomfort and genital pain with or without lower urinary tract symptoms (LUTS) and sexual dysfunction visiting our department from March 2009 to March 2011']","['appropriate antibiotic', 'phytotherapeutic agents', 'placebo']","['bacterial and symptom persistence rate', 'symptoms burden']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0748023', 'cui_str': 'Prostatitis caused by bacteria'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1535975', 'cui_str': 'Pelvic discomfort'}, {'cui': 'C0239725', 'cui_str': 'Genital pain'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}]",,0.013775,"We found no statistically significant differences between the two groups regarding bacterial and symptom persistence rate, however, symptoms burden was lower in patients receiving combinational treatment.
","[{'ForeName': 'Konstantinos Nikolaos', 'Initials': 'KN', 'LastName': 'Stamatiou', 'Affiliation': 'Department of Urology, Tzaneio Hospital, Pireas, Greece. stamatiouk@gmail.com.'}, {'ForeName': 'Hippocrates', 'Initials': 'H', 'LastName': 'Moschouris', 'Affiliation': 'Department of Urology, Tzaneio Hospital, Pireas,Greece.'}]",Urology journal,[]
900,32063109,"Protective effect of N-acetylcysteine on oxaliplatin-induced neurotoxicity in patients with colorectal and gastric cancers: A randomized, double blind, placebo-controlled, clinical trial.","PURPOSE


Neuropathy is one of the most prevalent and dose-limiting side effects of platinum chemotherapeutic agents. N-acetylcysteine is an antioxidant thiol which is able to increase whole blood concentration of glutathione, which may be protective against chemotherapy-induced neuropathy. The aim of this study was to evaluate the effect of N-acetylcysteine on neurotoxicity induced by oxaliplatin in patients with gastric or colorectal cancers.
METHODS


During this randomized, double-blinded, placebo-controlled clinical trial, the preventive effect of N-acetylcysteine effervescent tablets was assessed in comparison with placebo, on neuropathy occurrence. Thirty-two patients with colorectal or gastric cancer randomly received N-acetylcysteine (two 600 mg tablets) or placebo tablets 1 h before receiving oxaliplatin in dose in XELOX (oxaliplatin and capecitabine regimen) for eight courses of chemotherapy. Neuropathy severity was assessed after eight courses of chemotherapy based on National Cancer Institute Common Terminology for Adverse Events (NCI-CTCAE) criteria neuropathy grading scale and also sensory and motor electrophysiological assessment was performed by a neurologist.
RESULTS


The NCI-CTCAE scale grade of patients in intervention group was significantly lower than placebo group after eight course of oxaliplatin ( P  = 0.01); however, the sensory electrophysiological assessment result was not significantly different ( P  = 0.501). No patient in both group had motor electrophysiological changes.
CONCLUSION


The results of this study showed that N-acetylcysteine could reduce the incidence of the neuropathy induced by oxaliplatin and delay its occurrence in patients with gastric or colorectal cancers.",2020,,['patients with colorectal and gastric cancers'],"['oxaliplatin-induced neurotoxicity', 'placebo', 'N-acetylcysteine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]",[],,0.479953,,"[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Bondad', 'Affiliation': 'Department of Internal Medicine, Mashhad University of Medical sciences, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Boostani', 'Affiliation': 'Department of Neurology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Barri', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Elyasi', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Department of Hematology and Medical Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219900788']
901,25194077,Diode laser ablation of prostate and channel transurethral resection of prostate in patients with prostate cancer and bladder outlet obstruction symptoms.,"PURPOSE


To evaluate the efficacy of diode laser ablation of prostate for treating lower urinary tract symptoms (LUTS) in patients with locally advanced prostate cancer and comparing results with palli­ative transurethral resection of prostate (pTURP).
MATERIALS AND METHODS


Thirty-six known cases of locally advanced prostate cancer with a maximum urinary flow rate (Qmax) of 12 mL per second or less and an International Prostate Symptom Score (IPSS) of 20 or more were included in this study. Patients were randomized into two groups. The first group underwent pTURP and for the second group diode laser ablation of prostate was done. In 6 months post-operative follow up, patients were evaluated for IPSS, post void residual (PVR) urine volume, Qmax and possible complications such as urethral stricture or urinary incontinence.
RESULTS


Postoperatively, mean IPSS was 11.1 ± 4.1 in TURP group and 11.7 ± 3.6 in laser group (P = .64). Mean PVR was 18.4 ± 3.5 mL in TURP group and 17.7 ± 6.3 mL in laser group (P = .68). Mean Qmax in TURP and laser groups were measured 20.1 ± 4.5 mL/s and 19.4 ± 2.6 mL/s, respectively (P = .57). While there was a significant improvement in IPSS and Qmax and PVR in both groups, statisti­cal analysis did not show any significant difference postoperatively between pTURP and laser groups.
CONCLUSION


Diode laser ablation of prostate and pTURP, both improved significantly IPSS, PVR and Qmax. But hospital stay and post-operative catheterization time was less in laser group.",2014,"While there was a significant improvement in IPSS and Qmax and PVR in both groups, statisti­cal analysis did not show any significant difference postoperatively between pTURP and laser groups.
","['patients with prostate cancer and bladder outlet obstruction symptoms', 'Thirty-six known cases of locally advanced prostate cancer with a maximum urinary flow rate (Qmax) of 12 mL per second or less and an International Prostate Symptom Score (IPSS) of 20 or more were included in this study', 'patients with locally advanced prostate cancer']","['Diode laser ablation of prostate and channel transurethral resection of prostate', 'palli\xadative transurethral resection of prostate (pTURP', 'diode laser ablation of prostate', 'pTURP', 'TURP', 'Diode laser ablation of prostate and pTURP']","['IPSS, post void residual (PVR) urine volume, Qmax and possible complications such as urethral stricture or urinary incontinence', 'IPSS, PVR and Qmax', 'Mean PVR', 'But hospital stay and post-operative catheterization time', 'mean IPSS', 'Mean Qmax', 'IPSS and Qmax and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005694', 'cui_str': 'Bladder Outlet Obstruction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate (observable entity)'}, {'cui': 'C0565930', 'cui_str': '/s'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume (observable entity)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",36.0,0.0288237,"While there was a significant improvement in IPSS and Qmax and PVR in both groups, statisti­cal analysis did not show any significant difference postoperatively between pTURP and laser groups.
","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Javanmard', 'Affiliation': 'Department of Laser Application in Medical Sciences Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences.Tehran, Iran. dr_javanmard@yahoo.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Hassanzadeh Haddad', 'Affiliation': 'Department of Laser Application in Medical Sciences Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences.Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Yaghoobi', 'Affiliation': 'Department of Laser Application in Medical Sciences Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences.Tehran, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Lotfi', 'Affiliation': 'Department of Laser Application in Medical Sciences Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences.Tehran, Iran.'}]",Urology journal,[]
902,32419092,Image quality and radiation dose of different scanning protocols in DSCT cardiothoracic angiography for children with tetralogy of fallot.,"The aim of this study was to investigate the image quality and radiation dose of different scanning protocols in dual-source CT cardiothoracic angiography for children with tetralogy of Fallot (TOF). Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography. According to the scanning protocols, these patients were randomly divided into 3 groups: fixed delay time (FDT, n = 25, group A), automatic bolus-tracking (ABT, n = 25, group B) and manual bolus-tracking (MBT, n = 25, group C). Subjective and objective image quality were evaluated. The radiation doses were recorded. The image quality scores of group C were significantly higher than those of group A and B. The absolute value of difference (D-value) on CT attenuation between left (CT LV ) and right ventricle (CT RV ) in group C was significantly lower than that in group A and B. The total effective dose of groups A, B and C were 0.39 ± 0.06 mSv, 0.40 ± 0.07 mSv and 0.40 ± 0.08 mSv, respectively. There was no significant difference among 3 groups (P = 0.722). Scanning protocol has significantly impacts on the image quality of cardiovascular structures for TOF patients. Compared with the conventional scanning protocols FDT and ABT, the MBT technique provides high image quality and achieves more homogenous attenuation among different patients with TOF.",2020,The image quality scores of group C were significantly higher than those of group A and B.,"['children with tetralogy of fallot', 'children with tetralogy of Fallot (TOF', 'TOF patients', 'Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective']","['DSCT cardiothoracic angiography', 'scanning protocols in dual-source CT cardiothoracic angiography', 'ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography', 'fixed delay time (FDT, n\u2009=\u200925, group A), automatic bolus-tracking (ABT, n\u2009=\u200925, group B) and manual bolus-tracking (MBT']","['Subjective and objective image quality', 'CT attenuation between left (CT LV ) and right ventricle (CT RV ', 'image quality scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0167736,The image quality scores of group C were significantly higher than those of group A and B.,"[{'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Ultrasound, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baoting', 'Initials': 'B', 'LastName': 'Chao', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""CT Scientific Collaboration, Siemens Healthcare Limited, Beijing, 100102, People's Republic of China.""}, {'ForeName': 'Ximing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China. wxming369@163.com.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China. gmlu369@163.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01882-w']
903,26341763,"Combined Dietary Recommendations, Desmopressin, and Behavioral Interventions May Be Effective First-Line Treatment in Resolution of Enuresis.","PURPOSE


Nocturnal enuresis (NE) is a very common multifactorial pediatric disorder and in children with­out any other lower urinary tract symptoms is defined as monosymptomatic NE (MNE). Pharmacologi­cal, psychological/behavioral, and alternative interventions are commonly used and the first-line drug ther­apy for patients with MNE is desmopressin (dDAVP) but the response rate is less than 40-60% and the relapse rate is about 50-80% after treatment. Many studies show that some foods and beverages can promote diuresis or bladder irritability, which in some people can exacerbate bladder symptoms and NE. The pres­ent study aimed to compare the efficacy of combined specific dietary advices and dDAVP vs dDAVP alone.
MATERIALS AND METHODS


We enrolled in the study 172 patients affected by MNE between January 2013 and May 2014, of these 35 were excluded. The inclusion criterion was primary MNE and exclusion criteria included non-MNE, secondary MNE and lactose intolerance. Children were treated with dDAVP at a dose of 120 μg a day and were randomized to receive dietary recommendations. They were asked to fill out a char­ter depicting their wet and dry nights for the period of treatment. Sixty-seven patients were randomly as­signed to receive dDAVP and dietary advices (group A) and 70 patients to receive dDAVP alone (group B).
RESULTS


We included in our study 137 children, 102 (74.5%) male, and 35 (25.5%) female, aged be­tween 5 and 14 years. Our results show a higher response rate and a lower number of relapse in group A vs group B with 67.2% of responders in group A vs 58.6% in group B, after 3 months of ther­apy and 31.1% of relapse in group A vs 46.3% in group B one month, after the end of treatment.
CONCLUSION


Our results show the effectiveness of specific dietary advices in the manage­ment of primary MNE. However further studies are needed to determine whether the differ­ence between therapy with combined dietary recommendations and dDAVP vs dDAVP alone.",2015,"Our results show a higher response rate and a lower number of relapse in group A vs group B with 67.2% of responders in group A vs 58.6% in group B, after 3 months of ther­apy and 31.1% of relapse in group A vs 46.3% in group B one month, after the end of treatment.
","['We enrolled in the study 172 patients affected by MNE between January 2013 and May 2014, of these 35 were excluded', 'Sixty-seven patients', '137 children, 102 (74.5%) male, and 35 (25.5%) female, aged be\xadtween 5 and 14 years']","['dDAVP and dietary advices', 'dDAVP alone', 'desmopressin (dDAVP', 'dDAVP', 'Combined Dietary Recommendations, Desmopressin, and Behavioral Interventions', 'combined specific dietary advices and dDAVP vs dDAVP alone']","['relapse rate', 'response rate', 'number of relapse', 'diuresis or bladder irritability']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C2945586', 'cui_str': 'Bladder irritability (finding)'}]",67.0,0.0327511,"Our results show a higher response rate and a lower number of relapse in group A vs group B with 67.2% of responders in group A vs 58.6% in group B, after 3 months of ther­apy and 31.1% of relapse in group A vs 46.3% in group B one month, after the end of treatment.
","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrara', 'Affiliation': 'Institute of Pediatrics, Catholic University of Sacred Heart, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Del Volgo', 'Affiliation': 'Service of Pediatrics, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Romano', 'Affiliation': 'Institute of Pediatrics, Catholic University of Sacred Heart, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Scarpelli', 'Affiliation': 'Food Sciences and Human Nutrition Unit, Campus Bio-Medico University, Rome, Italy. scarpelli.valentina1@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Gara', 'Affiliation': 'Food Sciences and Human Nutrition Unit, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Giacinto Abele Donato', 'Initials': 'GA', 'LastName': 'Miggiano', 'Affiliation': 'Service of Clinical Nutrition, Catholic University of Sacred Heart, Rome, Italy.'}]",Urology journal,[]
904,26341762,"Minilaparoscopy vs. standard laparoscopic donor nephrectomy: comparison of safety, efficacy and cosmetic outcomes in a randomized clinical trial.","PURPOSE


This study was conducted to compare safety, efficacy and cosmetic outcome between standard laparoscopic live donor nephrectomy (sLDN) and mini-laparoscopic donor nephrectomy (mLDN) in a randomized clinical trial.
MATERIALS AND METHODS


From March 2012 to June 2013, 100 consecutive kidney donors were randomly assigned to two equal groups for laparoscopic donor nephrectomy. mLDN: Six to eight centimeters Pfannenstiel incision was made slightly above pubis symphysis and 11 millimeters trocar was fixed through exposed fascia using open technique. Five mm port was placed under direct vision at the umbilicus for camera insertion and two 3.5 mm ports were placed in subxiphoid and paraumbilical area. sLDN: Ten mm port was placed at umbilicus using open access technique for camera insertion. Five mm trocar for grasping and 11 mm trocar for vascular clipping were placed at subxiphoid and paraumbilical areas under direct vision, respectively. The second 5 mm trocar was placed in suprapubic area. Cosmetic appearance was assessed three months after surgery by using the Patient Scar Assessment Questionnaire (PSAQ).
RESULTS


Demographic data of the patients was not significantly different between two groups. Total operative time and ischemic time was nearly similar in both groups (104 ± 21 vs. 114 ± 24 min; P = .327 and 4.03 vs. 4.07 min; P = .592). There were no cases of conversion to open surgery. Mean hospital stay was similar between the two groups [2.1 (2-5) vs. 2.4 (2-5) days; P = .346]. Kidney graft function assessed by serum creatinine val­ues (mg/dL) of recipients, was equivalent in both groups (1.58 vs. 1.86: P = .206). Mean appearance score (34 vs. 29) and consciousness score (22 vs. 18) in PSAQ showed significantly better results in the mLDN group.
CONCLUSION


Our experience in this study revealed that peri- and post-operative findings were comparable between sLDN and mLDN, but mLDN has significant better cosmetic appearance than standard laparoscopic approach.",2015,Mean hospital stay was similar between the two groups [2.1 (2-5) vs. 2.4 (2-5) days; P = .346].,"['From March 2012 to June 2013, 100 consecutive kidney donors']","['laparoscopic donor nephrectomy', 'Pfannenstiel incision', 'sLDN', 'standard laparoscopic live donor nephrectomy (sLDN) and mini-laparoscopic donor nephrectomy (mLDN', 'Minilaparoscopy vs. standard laparoscopic donor nephrectomy']","['Mean hospital stay', 'Total operative time and ischemic time', 'safety, efficacy and cosmetic outcome', 'Kidney graft function assessed by serum creatinine val\xadues', 'Patient Scar Assessment Questionnaire (PSAQ', 'Mean appearance score', 'consciousness score', 'Cosmetic appearance', 'cosmetic appearance']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1313935', 'cui_str': 'Kidney donor'}]","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0457819', 'cui_str': 'Pfannenstiel incision (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4039558', 'cui_str': 'Laparoscopic live donor nephrectomy'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",,0.105353,Mean hospital stay was similar between the two groups [2.1 (2-5) vs. 2.4 (2-5) days; P = .346].,"[{'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Simforoosh', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Hosseini Sharifi', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Valipour', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Narouie', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Kamranmanesh', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Soltani', 'Affiliation': 'Shahid Labbafinejad Medical Center, Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.. mhsoltani60@gmail.com.'}]",Urology journal,[]
905,3733830,Trochanteric fractures of the femur. A randomised prospective trial comparing the Jewett nail-plate with the dynamic hip screw.,"In a randomised prospective trial 98 elderly women with trochanteric fractures of the femur were treated with either a 135 degrees Jewett nail-plate or a 135 degrees Dynamic hip screw. The results at six weeks, three months and six months were statistically analysed. There were no significant differences in the two groups with regard to pain, length of hospital stay, morbidity or mortality. Although operative difficulties and open reduction were more common with the Dynamic hip screw, at the end of six months more patients in this group were mobile and there was significant radiological evidence of better compression without loss of fixation.",1986,"There were no significant differences in the two groups with regard to pain, length of hospital stay, morbidity or mortality.","['Trochanteric fractures of the femur', '98 elderly women with trochanteric fractures of the femur']","['135 degrees Jewett nail-plate or a 135 degrees Dynamic hip screw', 'Jewett nail-plate with the dynamic hip screw']","['pain, length of hospital stay, morbidity or mortality']","[{'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}]","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",98.0,0.024149,"There were no significant differences in the two groups with regard to pain, length of hospital stay, morbidity or mortality.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Esser', 'Affiliation': ''}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Kassab', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Jones', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
906,32418142,Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.,"INTRODUCTION


Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients.
METHODS


In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups.
RESULTS


In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
CONCLUSION


MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT01735305.",2020,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","['Medically Managed Acute Coronary Syndrome Patients', 'Chinese Patients with Coronary Artery Disease', 'medically managed acute coronary syndrome (ACS) (MMACS) patients']","['DAPT', 'antiplatelet therapy (DAPT) duration', 'percutaneous coronary intervention', 'MMACS']","['rate of primary efficacy endpoint', 'Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events', 'Propensity score matching (PSM', 'bleeding risks', 'ischemic events', 'all bleeding, BARC 2-5, and BARC 3-5 bleeding', 'efficacy and safety of\u2009≥', 'composite of cardiac death, myocardial infarction, and stroke']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0365972,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups.
","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China. han1320288258@qq.com.'}]",Advances in therapy,['10.1007/s12325-020-01376-0']
907,25703908,A comparison of the effects of morphine and sublingual desmopressin combination therapy with morphine alone in treatment of renal colic: a controlled clinical trial.,"PURPOSE


To compare the therapeutic efficacy of combined desmopressin and morphine with morphine and placebo on acute renal colic.
MATERIALS AND METHODS


In a single blind case-control clinical trial 81 consecutive patients, 54 males and 27 females with the mean age of 30.12 ± 9.88 years, presenting with acute renal colic to the urology emergency unit were studied. The patients were randomly assigned into two groups. The 40 cases were treated with 0.1 mg/kg IM morphine and 60 μg of sublingual desmopressin melt; whereas the 41 controls received the same dose of morphine beside a placebo.
RESULTS


There were no significant statistical differences regarding the mean age, gender, stone size, location and affected side between the two groups. Our results showed a significantly higher acuity of pain in the study group in comparison to the controls at 10, 20 and 30 minutes of receiving the medication (P = .06, .017 and P = .008, respectively).
CONCLUSION


No superiority was found in adding desmopressin to morphine compared to the traditional treatments (opioids only) in relieving the pain of acute renal colic cases.",2015,"There were no significant statistical differences regarding the mean age, gender, stone size, location and affected side between the two groups.","['81 consecutive patients, 54 males and 27 females with the mean age of 30.12 ± 9.88 years, presenting with acute renal colic to the urology emergency unit were studied']","['morphine', 'combined desmopressin and morphine with morphine and placebo', 'IM morphine', 'morphine beside a placebo', 'morphine alone', 'morphine and sublingual desmopressin combination therapy', 'sublingual desmopressin melt']","['acuity of pain', 'pain of acute renal colic cases', 'renal colic', 'therapeutic efficacy', 'acute renal colic']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0599882', 'cui_str': 'Melting'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",81.0,0.0272566,"There were no significant statistical differences regarding the mean age, gender, stone size, location and affected side between the two groups.","[{'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Keshvari Shirvani', 'Affiliation': 'Department of Urology, Mashhad University of Medical Sciences, Mashhad, Iran.. Keshvarim@mums.ac.ir.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Darabi Mahboub', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Ghazi', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Delijani', 'Affiliation': ''}]",Urology journal,[]
908,32420825,Group social work intervention enhances the sexual satisfaction of women with Multiple Sclerosis: a randomized controlled trial study.,"Sexual problems are among the most common disorders that people with Multiple Sclerosis have to deal with, resulting in decreased sexual satisfaction and quality of life. The study is aimed to investigate the impact of group social work intervention on the sexual satisfaction of women with Multiple Sclerosis. The methodology was a randomized controlled trial and 58 participants recruited (30 for control group and 28 for intervention group). The intervention was based on group social work with an empowerment approach within eight sessions. The average age of the participants was 35.95 ± 6.41 most of whom had high school diploma (62.1%). The findings indicate that, in terms of sexual satisfaction (t = 5.47, Sig = 0.03, df = 56), primary disorders (t = 2.42, Sig = 0.019, df = 56), and tertiary disorders (t = 3.77, Sig = 0.002, df = 56), there is a significant difference between intervention and control groups.",2020,", there is a significant difference between intervention and control groups.","['The average age of the participants was 35.95\xa0±', 'df\xa0=\xa056', 'women with Multiple Sclerosis', '58 participants recruited (30 for control group and 28 for intervention group']",['social work intervention'],"['sexual satisfaction', 'sexual satisfaction and quality of life', 'tertiary disorders']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",58.0,0.0694324,", there is a significant difference between intervention and control groups.","[{'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Arshi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Fahime', 'Initials': 'F', 'LastName': 'Sheybani', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Eghlima', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shati', 'Affiliation': 'Mental Health Research Center, Social Injury Prevention Research Institute, Iran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Moghanibashi-Mansourieh', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moshayyedi', 'Affiliation': 'Social Work Department, University of Social Welfare and Rehabilitation Sciences , Tehran, Iran.'}]",Social work in health care,['10.1080/00981389.2020.1762148']
909,32425111,Single-dwell treatment with a low-sodium solution in hypertensive peritoneal dialysis patients.,"BACKGROUND


Patients on peritoneal dialysis (PD) may suffer from sodium (Na) and fluid overload, hypertension and increased cardiovascular risk. Low-Na dialysis solution, by increasing the diffusive removal of Na, might improve blood pressure (BP) management.
METHODS


A glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose) was compared to a standard-Na solution (133 mmol/L Na and 1.5% glucose) in a prospective, randomised, single-blind study in hypertensive patients on PD. One daily exchange of the standard dialysis regimen was substituted by either of the study solutions for 6 months. The primary outcome (response) was defined as either a decrease of 24-h systolic BP (SBP) by ≥6 mmHg or a fall in BP requiring a medical intervention (e.g. a reduction of antihypertensive medication) at 8 weeks.
RESULTS


One hundred twenty-three patients were assessed for efficacy. Response criteria were achieved in 34.5% and 29.1% of patients using low- and standard-Na solutions, respectively ( p  = 0.51). Small reductions in 24 h, office, and self-measured BP were observed, more marked with low-Na than with standard-Na solution, but only the between-group difference for self-measured SBP and diastolic BP was significant ( p  = 0.002 and  p  = 0.003). Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant. Hypotension and dizziness occurred in 27.0% and in 11.1% of patients in the low-Na group and in 16.9% and 4.6% in the control group, respectively.
CONCLUSIONS


Superiority of low-Na PD solution over standard-Na solution for control of BP could not be shown. The once daily use of a low-Na PD solution was associated with more hypotensive episodes, suggesting the need to reassess the overall concept of how Na-reduced solutions might be incorporated within the treatment schedule.",2020,"Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant.","['Patients on peritoneal dialysis (PD', 'One hundred twenty-three patients', 'hypertensive patients on PD', 'hypertensive peritoneal dialysis patients']","['Single-dwell treatment with a low-sodium solution', 'standard-Na solution (133 mmol/L Na and 1.5% glucose', 'low-Na PD solution', 'glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose']","['Total body water', 'self-measured SBP and diastolic BP', 'Small reductions in 24 h, office, and self-measured BP', '24-h systolic BP (SBP', 'blood pressure (BP) management', 'Hypotension and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0353714', 'cui_str': 'Peritoneal dialysis solution'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",123.0,0.0336869,"Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Davies', 'Affiliation': 'Faculty of Medicine and Health Sciences, 4212Keele University, Staffordshire, UK.'}, {'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Haraldsson', 'Affiliation': 'Department of Physiology, 3570University of Gothenburg, Sweden.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vrtovsnik', 'Affiliation': 'Department of Nephrology, 55076Xavier Bichat Hospital, Paris, France.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Schwenger', 'Affiliation': 'Department of Nephrology, 9203Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Nephrology, The Royal London Hospital, London, UK.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'Department of Nephrology, 55454Hospital Louis Pasteur, Colmar, France.'}, {'ForeName': 'Saynab', 'Initials': 'S', 'LastName': 'Atiye', 'Affiliation': '206662Fresenius Medical Care, Bad Homburg, Germany.'}, {'ForeName': 'Adelheid', 'Initials': 'A', 'LastName': 'Gauly', 'Affiliation': '206662Fresenius Medical Care, Bad Homburg, Germany.'}]",Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.1177/0896860820924136']
910,3818719,Adolescent idiopathic thoracic scoliosis. A prospective trial with and without bracing during postoperative care.,"Fifty patients with adolescent idiopathic scoliosis treated by posterior fusion and Harrington instrumentation augmented by a Cotrel bar or by sublaminal Luque wires were studied in a prospective trial to ascertain the need for postoperative bracing. Twenty-five patients wore a plaster brace postoperatively for six months, while 25 were managed without a brace. The mean loss of correction from the first standing postoperative radiograph to one obtained two years later was 7 degrees in the braced group, and 6.3 degrees in the unbraced group, the difference not being statistically significant. We conclude that postoperative bracing is unnecessary after augmented Harrington instrumentation.",1987,"The mean loss of correction from the first standing postoperative radiograph to one obtained two years later was 7 degrees in the braced group, and 6.3 degrees in the unbraced group, the difference not being statistically significant.","['Fifty patients with adolescent idiopathic scoliosis treated by posterior fusion and Harrington instrumentation augmented by a Cotrel bar or by sublaminal Luque wires', 'Adolescent idiopathic thoracic scoliosis']",['plaster brace'],['mean loss of correction'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}]","[{'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",50.0,0.0197125,"The mean loss of correction from the first standing postoperative radiograph to one obtained two years later was 7 degrees in the braced group, and 6.3 degrees in the unbraced group, the difference not being statistically significant.","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Christodoulou', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Prince', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Webb', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Burwell', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
911,24595941,"Percutaneous nerve evaluation (PNE) for treatment of non-obstructive urinary retention: urodynamic changes, placebo effects, and response rates.","PURPOSE


To evaluate the results of percutaneous nerve evaluation (PNE) implantation in the treatment of non-obstructive urinary retention and report the changes in the urodynamic parameters.
MATERIALS AND METHODS


Patients with non-obstructive urinary retention or incomplete bladder emptying were included. All patients filled a 7 days voiding diary chart and underwent PNE for one week, and the patient was asked to record the second voiding diary chart and repeat urodynamic study in this period. Then the PNE lead was removed from the S3 foramen, but the connections remained fixed in place for another 3 days to exclude the placebo effects and the third voiding diary chart was completed by the patient. The patient wasn't aware of lead removal. Success was defined as, more than 50% improvement in at least one of the urinary tract symptoms.
RESULTS


Forty five patients with a mean age of 37.1 years (ranged 9-83 years) were treated with PNE for refractory, non-obstructive urinary retention. Of study subjects 28 complained from complete urinary retention, and 17 had incomplete emptying. Of participants, 28 (62.2%) demonstrated greater than 50% improvement in the urinary symptoms. Urodynamic data, showed a statistically significant increase in maximum flow rate (8 ± 2.2 mL/sec to 16 ± 3.6 mL/sec, P = .06) and voided volume (35 mL to 187 mL, P = .032) in the responders. Any placebo effects in PNE have not been seen.
CONCLUSION


Patients with complete non obstructive urinary retention were good responders to PNE. The placebo effect in sacral nerve stimulation was negligible.",2014,"Urodynamic data, showed a statistically significant increase in maximum flow rate (8 ± 2.2 mL/sec to 16 ± 3.6 mL/sec, P = .06) and voided volume (35 mL to 187 mL, P = .032) in the responders.","['Forty five patients with a mean age of 37.1 years (ranged 9-83 years', 'Of study subjects 28 complained from complete urinary retention, and 17 had incomplete emptying', 'Patients with non-obstructive urinary retention or incomplete bladder emptying were included']","['PNE', 'placebo', 'percutaneous nerve evaluation (PNE) implantation', 'Percutaneous nerve evaluation (PNE']","['obstructive urinary retention', 'maximum flow rate', 'urinary symptoms', 'voided volume', 'urinary tract symptoms', 'sacral nerve stimulation']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0344365', 'cui_str': 'Incomplete emptying of bladder (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2609267', 'cui_str': 'Sacral nerve stimulation'}]",28.0,0.111949,"Urodynamic data, showed a statistically significant increase in maximum flow rate (8 ± 2.2 mL/sec to 16 ± 3.6 mL/sec, P = .06) and voided volume (35 mL to 187 mL, P = .032) in the responders.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Sharifiaghdas', 'Affiliation': 'Department of Urology, Shaheed Labbafinejad Medical Center, Urology and Nephrology Research Center, Shaheed Beheshti University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Department of Urology, Shaheed Labbafinejad Medical Center, Urology and Nephrology Research Center, Shaheed Beheshti University of Medical Sciences Tehran, Iran.mirzaeimahboubeh@yahoo.com.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Ahadi', 'Affiliation': 'Department of Urology, Shaheed Labbafinejad Medical Center, Urology and Nephrology Research Center, Shaheed Beheshti University of Medical Sciences Tehran, Iran.'}]",Urology journal,[]
912,24595942,The effect of garlic powder on human urinary cytokine excretion.,"PURPOSE


To evaluate the effects of orally administered dehydrated garlic powder on cytokine excretion in the urinary tract.
MATERIALS AND METHODS


A total of 60 healthy volunteers, randomized into 3 groups, were given a single oral dose of 1 g or 3 g of dehydrated garlic powder or placebo. Urine samples were obtained 6.0 and 24.0 h after garlic intake and assayed for interleukin-8 (IL-8), interleukin- 12 (IL-12), tumor necrosis factor-alpha (TNF-α), diallyl disulfide (DADS) and diallyl sulfide (DAS).
RESULTS


Significant increases in IL-12 levels over baseline were noted in urine samples obtained after oral intake of 1 g and 3 g of garlic powder (P < .001). In the 1 g and 3 g garlic powder treatment groups, time-dependent variations in IL-12 levels over the study period were significantly different from the placebo group (P < .001). In both garlic treatment groups, urinary levels of IL-8 and TNF-α were not significantly different from baseline and placebo levels (P > .017). DADS and DAS were not detected in the urine samples at any time after garlic powder intake.
CONCLUSION


Oral intake of doses of garlic traditionally used for daily supplementation increases urinary levels of IL-12, which is a potent stimulator of T helper cell 1 (Th-1) immune responses. This observation encourages further studies investigating the immunostimulatory role of garlic in the urinary tract.",2014,"In both garlic treatment groups, urinary levels of IL-8 and TNF-α were not significantly different from baseline and placebo levels (P > .017).",['60 healthy volunteers'],"['dehydrated garlic powder', 'placebo', 'garlic powder', 'garlic', 'dehydrated garlic powder or placebo']","['DADS and DAS', 'IL-12 levels', 'interleukin-8 (IL-8), interleukin- 12 (IL-12), tumor necrosis factor-alpha (TNF-α), diallyl disulfide (DADS) and diallyl sulfide (DAS', 'urinary levels of IL-12', 'cytokine excretion', 'urinary levels of IL-8 and TNF-α', 'human urinary cytokine excretion', 'time-dependent variations in IL-12 levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0057693', 'cui_str': 'allyl disulfide'}, {'cui': 'C0051235', 'cui_str': 'allyl sulfide'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",60.0,0.235471,"In both garlic treatment groups, urinary levels of IL-8 and TNF-α were not significantly different from baseline and placebo levels (P > .017).","[{'ForeName': 'Ergun', 'Initials': 'E', 'LastName': 'Alma', 'Affiliation': 'Department of Urology, Ceyhan State Hospital, Ceyhan, Adana, Turkey.almaerim@yahoo.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Eken', 'Affiliation': 'Department of Urology, Acibadem Adana Hospital, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ercil', 'Affiliation': 'Department of Urology, Adana Numune Education and Research Hospital, Adana, Turkey.'}, {'ForeName': 'Kazim', 'Initials': 'K', 'LastName': 'Yelsel', 'Affiliation': 'Department of Urology, Viransehir State Hospital, Viransehir, Urfa, Turkey.'}, {'ForeName': 'Nebile', 'Initials': 'N', 'LastName': 'Daglioglu', 'Affiliation': 'Department of Forensic Medicine, Cukurova University Adana, Turkey.'}]",Urology journal,[]
913,31343948,"""Beet"" the cold: beetroot juice supplementation improves peripheral blood flow, endothelial function, and anti-inflammatory status in individuals with Raynaud's phenomenon.","Raynaud's phenomenon (RP) is characterized by recurrent transient peripheral vasospasm and lower nitric oxide (NO) bioavailability in the cold. We investigated the effect of nitrate-rich beetroot juice (BJ) supplementation on  1 ) NO-mediated vasodilation,  2 ) cutaneous vascular conductance (CVC) and skin temperature (T sk ) following local cooling, and  3 ) systemic anti-inflammatory status. Following baseline testing, 23 individuals with RP attended four times, in a double-blind, randomized crossover design, following acute and chronic (14 days) BJ and nitrate-depleted beetroot juice (NDBJ) supplementation. Peripheral T sk  and CVC were measured during and after mild hand and foot cooling, and during transdermal delivery of acetylcholine and sodium nitroprusside. Markers of anti-inflammatory status were also measured. Plasma nitrite concentration ([nitrite]) was increased in the BJ conditions ( P  < 0.001). Compared with the baseline visit, thumb CVC was greater following chronic-BJ (Δ2.0 flux/mmHg,  P  = 0.02) and chronic-NDBJ (Δ1.45 flux/mmHg,  P  = 0.01) supplementation; however, no changes in T sk  were observed ( P  > 0.05). Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved, by both BJ and NDBJ supplementation ( P  < 0.05). Acute and chronic BJ and NDBJ supplementation improved anti-inflammatory status, endothelial function and blood pressure (BP). CVC following cooling increased post chronic-BJ and chronic-NDBJ supplementation, but no effect on T sk  was observed. The key findings are that beetroot supplementation improves thumb blood flow, improves endothelial function and anti-inflammatory status, and reduces BP in people with Raynaud's. NEW & NOTEWORTHY  This is the first study to examine the effect of dietary nitrate supplementation in individuals with Raynaud's phenomenon. The principal novel findings from this study were that both beetroot juice and nitrate-depleted beetroot juice  1 ) increased blood flow in the thumb following a cold challenge;  2 ) enhanced endothelium-dependent and -independent vasodilation in the forearm;  3 ) reduced systolic and diastolic blood pressure, and pan-endothelin concentration; and  4 ) improved inflammatory status in comparison to baseline.",2019,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[""individuals with Raynaud's phenomenon""]","['NDBJ supplementation', 'nitrate-depleted beetroot juice (NDBJ) supplementation', 'acetylcholine and sodium nitroprusside', 'nitrate-rich beetroot juice (BJ) supplementation']","['Plasma [interleukin-10', 'Peripheral T sk  and CVC', 'peripheral blood flow, endothelial function and anti-inflammatory status', 'nitric oxide (NO) bioavailability', 'chronic-NDBJ', 'pan endothelin and systolic and diastolic blood pressure (BP', 'anti-inflammatory status, endothelial function and BP', 'forearm endothelial function', 'Plasma [nitrite', 'T sk', 'i)  NO-mediated vasodilation,  ii)  cutaneous vascular conductance (CVC) and skin temperature (T sk ']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0034735', 'cui_str': 'Raynaud Phenomenon'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0079284', 'cui_str': 'Endothelium-Derived Vasoconstrictor Factors'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",23.0,0.1203,"Plasma [interleukin-10] was greater, pan endothelin and systolic and diastolic blood pressure (BP) were reduced, and forearm endothelial function was improved ,by both BR and NDBJ supplementation ( P  < 0.05).","[{'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Shepherd', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Costello', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Bishop', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, United Kingdom.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Young-Min', 'Affiliation': 'Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gilchrist', 'Affiliation': 'University of Exeter Medical School and NIHR Exeter Clinical Research Facility, Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mayes', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gorczynski', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Zoe L', 'Initials': 'ZL', 'LastName': 'Saynor', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Massey', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Clare M', 'Initials': 'CM', 'LastName': 'Eglin', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, United Kingdom.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00292.2019']
914,25015597,Percutaneous nephrolithotomy: is distilled water as safe as saline for irrigation?,"PURPOSE


To compare dilutional effect of distilled water with saline solution as an irrigation fluid in percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS


Three hundred twenty eight adult patients (191 men, 137 women) who were candidates for PCNL were randomly assigned into two groups (distilled water, n = 158, group 1; saline solution, n = 162, group 2). Stone size, operation time, irrigation fluid volume, blood hemoglobin level, urea nitrogen, creatinine, sodium and potassium levels were checked before and at 6 and 12 hours after operation.
RESULTS


The mean age of the patients was 37.8 years, and the mean stone diameter was 31.5 mm. There was no clinical case of transurethral resection (TUR) syndrome. Serum sodium depletion was significantly more in group 1 than group 2 (P < .0001). Group 1 had significant decreased post-operative serum sodium levels (P < .0003). Similarly in group 2, postoperative serum sodium levels were significantly lower than the preoperative concentration (P < .01), but it was not the same 6 hours after the operation (P = .23). Serum sodium concentrations remained within normal limits in all cases, without causing clinical signs and symptoms of hyponatremia.
CONCLUSION


We found that distilled water is safe irrigation fluid for PCNL in adults. In addition, it is more available and cost effective.",2014,"Similarly in group 2, postoperative serum sodium levels were significantly lower than the preoperative concentration (P < .01), but it was not the same 6 hours after the operation (P = .23).","['percutaneous nephrolithotomy (PCNL', 'adults', 'Three hundred twenty eight adult patients (191 men, 137 women) who were candidates for PCNL']","['distilled water with saline solution', 'Percutaneous nephrolithotomy', 'saline solution']","['post-operative serum sodium levels', 'postoperative serum sodium levels', 'mean stone diameter', 'Serum sodium concentrations', 'Stone size, operation time, irrigation fluid volume, blood hemoglobin level, urea nitrogen, creatinine, sodium and potassium levels', 'transurethral resection (TUR) syndrome', 'Serum sodium depletion']","[{'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}, {'cui': 'C0349610', 'cui_str': 'TUR syndrome'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}]",328.0,0.0194401,"Similarly in group 2, postoperative serum sodium levels were significantly lower than the preoperative concentration (P < .01), but it was not the same 6 hours after the operation (P = .23).","[{'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Hosseini', 'Affiliation': 'Department of Urology, Endourology Division, Urology Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Hassanpour', 'Affiliation': 'Department of Urology, Endourology Division, Urology Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. hassanpour74@yahoo.com.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Manaheji', 'Affiliation': 'Department of Urology, Endourology Division, Urology Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Yousefi', 'Affiliation': 'Department of Urology,Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Damshenas', 'Affiliation': 'Department of Anesthesiology, Jahrom University of Medical Sciences, Jahrom, Iran.'}, {'ForeName': 'Sezaneh', 'Initials': 'S', 'LastName': 'Haghpanah', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Urology journal,[]
915,25015615,Is the double dose alpha-blocker treatment superior than the single dose in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia?,"PURPOSE


To compare the efficacy and safety of single (tamsulosin) and double dose (tamsulosin + alfuzosin) alpha-blocker therapy for treating catheterized patients with acute urinary retention (AUR) due to benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Seventy patients with AUR due to BPH were catheterized and randomized into two groups: the single dose group (0.4 mg tamsulosin, 35 patients) and the double dose group (0.4 mg tamsulosin + 10 mg alfuzosin, 35 patients). The catheter was removed after 3 days, and the patients were put on trial without catheter (TWOC).
RESULTS


Seventy males (mean age, 71.2 years) were randomly assigned to receive double or single dose alpha-blocker (35 patients per group). The intent-to-treat population consisted of 70 males. Twenty-seven individuals in the double dose group and 19 in the single dose group did not require re-catheterization on the day of the TWOC (77% and 54%, respectively; P = .003). Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy (48% vs. 40%; P = .017).
CONCLUSION


TWOC was more successful in males treated with double dose alpha-blockers, and the subsequent need for re-catheterization was also reduced. The side-effect profiles were similar in the single and double dose alpha-blocker groups and were consistent with the known pharmacology. These results state that double dose alpha-blocker treatment can be recommended for treating males after catheterization for AUR, which may reduce the need for re-catheterization.",2014,"Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy (48% vs. 40%; P = .017).
","['Seventy males (mean age, 71.2 years', 'patients suffering from acute urinary retention caused by benign prostatic hyperplasia', 'Seventy patients with AUR due to BPH', 'catheterized patients with acute urinary retention (AUR) due to benign prostatic hyperplasia (BPH']","['tamsulosin', 'tamsulosin + 10 mg alfuzosin', 'single (tamsulosin) and double dose (tamsulosin + alfuzosin) alpha-blocker therapy', 'double or single dose alpha-blocker']","['efficacy and safety', 'require re-catheterization']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]",70.0,0.082796,"Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy (48% vs. 40%; P = .017).
","[{'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Kara', 'Affiliation': 'Department of Urology, Hacettepe University School of Medicine, 06100, Ankara, Turkey. onerkara@yahoo.com.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Yazici', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ankara University School of Medicine, 06100, Ankara, Turkey.'}]",Urology journal,[]
916,24469649,Mini-laparoscopic live donor nephrectomy: initial series.,"PURPOSE


To present the safety and surgical outcomes of the initial series of mini-laparoscopic live donor nephrectomy and graft outcomes in related recipients.
MATERIALS AND METHODS


From January 2012 through July 2012, fifty patients underwent minilaparoscopic live donor nephrectomy. Two 3.5 mm trocars were inserted above and lateral to the umbilicus for grasping and scissoring. One 5 mm trocar with a camera was inserted in the umbilicus and an 11 mm trocar was inserted through fascia from a 6-8 cm Pfannenstiel incision for bipolar coagulation, kidney extraction, and vascular clip applier.
RESULTS


Mean age of donors was 28 ± 4.2 (range, 21-39) years. Mean operative time from trocar insertion was 145.8 (range, 85-210) minutes. No major perioperative or postoperative complications occurred. The average decrease in hemoglobin level was 1.14 (range, 0.32-1.8) mg/dL and no one required blood transfusion. Mean warm ischemia time was 4.41 (range, 2.35- 9) minutes. Mean hospital stay was 2.2 (range, 2-5) days. Mean follow-up time of the recipients was 215 (range, 130-270) days. The mean serum creatinine level of the recipients at discharge time and the last follow-up visit was 1.38 mg/dL and 1.22 mg/dL, respectively.
CONCLUSIONS


While the primary purpose of this technique is to make donor nephrectomy less invasive and more cosmetic, it is also comfortable for the laparoscopist surgeons because it is nearly similar to standard laparoscopy. A randomized controlled trial with a large sample size, long-term follow-up, and comparison with standard laparoscopy are necessary to present more definitive data about this technique.",2014,No major perioperative or postoperative complications occurred.,"['From January 2012 through July 2012, fifty patients underwent', 'Mean age of donors was 28 ± 4.2 (range, 21-39) years', 'related recipients']","['standard laparoscopy', 'One 5 mm trocar with a camera was inserted in the umbilicus and an 11 mm trocar was inserted through fascia from a 6-8 cm Pfannenstiel incision for bipolar coagulation, kidney extraction, and vascular clip applier', 'Mini-laparoscopic live donor nephrectomy', 'mini-laparoscopic live donor nephrectomy', 'minilaparoscopic live donor nephrectomy']","['Mean warm ischemia time', 'Mean hospital stay', 'major perioperative or postoperative complications', 'hemoglobin level', 'Mean operative time from trocar insertion', 'blood transfusion', 'mean serum creatinine level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0457819', 'cui_str': 'Pfannenstiel incision (procedure)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0179992', 'cui_str': 'Vascular clip'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C4039558', 'cui_str': 'Laparoscopic live donor nephrectomy'}, {'cui': 'C0401187', 'cui_str': 'Donation of kidney'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}]",,0.0618621,No major perioperative or postoperative complications occurred.,"[{'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Simforoosh', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences. simforoosh@iurtc.org.ir.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Soltani', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Seyed Hossein', 'Initials': 'SH', 'LastName': 'Hosseini Sharifi', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahanian', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Lashay', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences.'}]",Urology journal,[]
917,31468988,The impact of relocation stress on cognitively impaired and cognitively unimpaired long-term care residents.,"Objectives:  The current aims were to explore the effects of relocation stress on depression and anxiety in long-term care residents and to investigate the moderating effect of cognitive status. Methods:  The study used existing data from nursing home and congregate apartment residents. Self-reported measures of relocation stress, cognitive status, depression, and anxiety were examined. Exploratory analyses examined group differences in depression and anxiety within the full sample ( n  = 568) and the sample of first-year residents ( n  = 347). Main analyses were conducted in a subsample of 107 first-year residents who completed the measure of relocation stress. Results:  Residents who had moved in the past year reported more anxiety but not depression than longer-term residents. Relocation stress significantly predicted depression but not anxiety in the subsample of first-year residents. There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety. Conclusion:  Findings suggest that cognitively impaired older adults are no more vulnerable to the negative effects of relocation stress than cognitively unimpaired older adults. Relocation stress should be regarded as a risk factor for depression in long-term care residents, regardless of cognitive status, in the first year after relocation.",2020,There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety.  ,"['Results:  Residents who had moved in the past year', 'subsample of 107 first-year residents who completed the measure of relocation stress', 'cognitively unimpaired older adults', 'nursing home and congregate apartment residents', 'cognitively impaired older adults', 'within the full sample ( n \u2009=\u2009568) and the sample of first-year residents ( n \u2009=\u2009347', 'cognitively impaired and cognitively unimpaired long-term care residents']",['relocation stress'],"['relocation stress, cognitive status, depression, and anxiety', 'depression and anxiety', 'cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety', 'anxiety']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0457933', 'cui_str': 'Residential flat'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0023977'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",568.0,0.0172567,There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety.  ,"[{'ForeName': 'Kyrsten', 'Initials': 'K', 'LastName': 'Costlow', 'Affiliation': 'Alabama Research Institute on Aging and Department of Psychology, University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parmelee', 'Affiliation': 'Alabama Research Institute on Aging and Department of Psychology, University of Alabama, Tuscaloosa, AL, USA.'}]",Aging & mental health,['10.1080/13607863.2019.1660855']
918,24078500,Comparative study between three analgesic agents for the pain management during extracorporeal shock wave lithotripsy.,"PURPOSE


To compare the clinical efficacy between locally applied diclofenac diethylamine gel, EMLA cream and systemically given diclofenac sodium for the pain relief during extracorporeal shock wave lithotripsy (SWL) using Dornier Delta Compact Lithotripter.
MATERIAL AND METHODS


One hundred five patients with renal stones were randomly divided in to 3 groups. Group A was given intramuscular diclofenac sodium (1 mg/kg), 45 minutes before the procedure. In group B, 10 gm of eutectic mixture of local anesthetic (EMLA) cream and in group C, 15 gm of diclofenac diethylamine gel was applied locally 45 minutes before the procedure. Ten-score linear and visual analogue scale (VAS) was used to assess the severity of pain during the procedure. Analysis of variance (ANOVA) test was used to compare various parameters and analyzed statistically.
RESULTS


All the three groups were not statistically different with respect to age, weight, stone size, number of shock wave delivered and maximum voltage used (P > .05). The mean pain score in group A was 4.48, in group B was 3.60 and in group C was 3.95, which were not significantly different (P = 1.34). Complication like skin lesion was found only in injection diclofenac sodium group whereas cold sensation at the local site was typically found in diclofenac diethylamine gel group.
CONCLUSION


Although not statistically significant, the mean pain score in locally applied analgesic agents (EMLA and diclofenac diethylamine gel) is lower as compared to intramuscularly given diclofenac sodium. Among these two locally acting drugs, diclofenac diethylamine gel is an equally effective alternative to EMLA.",2013,"All the three groups were not statistically different with respect to age, weight, stone size, number of shock wave delivered and maximum voltage used (P > .05).",['One hundred five patients with renal stones'],"['intramuscular diclofenac sodium', 'diclofenac diethylamine gel', 'eutectic mixture of local anesthetic (EMLA) cream', 'diclofenac sodium', 'diclofenac diethylamine gel, EMLA cream', 'extracorporeal shock wave lithotripsy']","['severity of pain', 'mean pain score', 'pain relief', 'Complication like skin lesion', 'cold sensation', 'visual analogue scale (VAS']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0771369', 'cui_str': 'diclofenac diethylammonium'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0360032', 'cui_str': 'EMLA Cream'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",105.0,0.0117417,"All the three groups were not statistically different with respect to age, weight, stone size, number of shock wave delivered and maximum voltage used (P > .05).","[{'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Yun-Jiang Zang, Department of Urologic Surgery, Weifang People's Hospital, 151 Guangwen Street, Kuiwen District, Weifang, Shandong, China. yunshanzang@gmail.com.""}, {'ForeName': 'Yun-Jiang', 'Initials': 'YJ', 'LastName': 'Zang', 'Affiliation': ''}]",Urology journal,[]
919,24078507,Unwanted intra-operative penile erection during pediatric hypospadiasis repair. Comparison of propofol and halothane.,"PURPOSE


To compare the erectile effect of propofol and halothane on unwanted intraoperative penile erection (UIOPE) during pediatric hypospadiasis repair.
MATERIALS AND METHODS


One hundred and seventeen boys who were in the age range of 6 months to 6 years and referred for hypospadiasis repair to our referral teaching hospital were included in this randomized clinical trial. Patients were randomly assigned to one of the two study groups before anesthesia induction. Anesthesia was maintained with a continuous intravenous infusion of propofol and inhalational halothane in the propofol (P) and halothane (H) groups, respectively. Data regarding the patients’ age, weight, pre- and intra-operative chordee, UIOPE, anesthesia time, surgery time, hematoma formation, and wound infection were collected. The Chi-Square and Fisher’s exact tests were used for comparison.
RESULTS


No statistically significant differences were noted regarding age, weight, and pre and intra-operative chordee between the two groups. The incidence of UIOPE (10.34% versus 57.63%; P = .000), anesthesia time (174.15 +/- 15.02 versus 181.26 +/- 15.19; P =.012), and surgery time (162.34 +/- 12.99 versus 167.69 +/- 13.90 +/- 13.90; P = .034) were significantly lower in group P compared with group H.
CONCLUSION


The use of propofol during hypospadiasis surgical repair is more safe and effective than halothane in preventing UIOPE and reducing surgery and anesthesia time.",2013,"No statistically significant differences were noted regarding age, weight, and pre and intra-operative chordee between the two groups.","['pediatric hypospadiasis repair', 'One hundred and seventeen boys who were in the age range of 6 months to 6 years and referred for hypospadiasis repair to our referral teaching hospital']","['halothane', 'propofol and halothane', 'propofol and inhalational halothane', 'propofol (P) and halothane (H', 'propofol']","['patients’ age, weight, pre- and intra-operative chordee, UIOPE, anesthesia time, surgery time, hematoma formation, and wound infection', 'age, weight, and pre and intra-operative chordee', 'anesthesia time', 'incidence of UIOPE', 'surgery time', 'intraoperative penile erection (UIOPE']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0018549', 'cui_str': 'Halothane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0221182', 'cui_str': 'Chordee (disorder)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030847', 'cui_str': 'Penile Erection'}]",117.0,0.0299388,"No statistically significant differences were noted regarding age, weight, and pre and intra-operative chordee between the two groups.","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Abbasi', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Parsian Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. mr-hajiesmaeili@razi.tums.ac.ir.'}, {'ForeName': 'Seyed Soheil', 'Initials': 'SS', 'LastName': 'Ben Razavi', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Hajiesmaeili', 'Affiliation': ''}, {'ForeName': 'Shekoufeh', 'Initials': 'S', 'LastName': 'Behdad', 'Affiliation': ''}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Ghiamat', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': ''}]",Urology journal,[]
920,24034568,Comparison and validation of 2 analytical methods for measurement of urinary sucrose and fructose excretion.,"Urinary sugars excretion has been proposed as a potential biomarker for intake of sugars. In this study, we compared 2 analytical methods (gas chromatography [GC] and enzymatic reactions-UV absorption) for quantifying urinary fructose and sucrose using 24-hour urine samples from a randomized crossover controlled feeding study. All samples were successfully quantified by the GC method; however, 21% and 1.9% of samples were below the detection limit of the enzymatic method for sucrose and fructose, respectively. Although the correlation between the 2 methods was good for fructose (Pearson correlation, 0.71), the correlation was weak for sucrose (Pearson correlation, 0.27). We favor the GC method because of its better sensitivity, simplicity, and the ability to quantify fructose and sucrose directly in the same run. Of the 106 samples from 53 participants with complete urine collection after 2 study diets, 24-hour urinary fructose excretion was significantly associated with fructose intake. The sum of 24-hour urinary fructose and sucrose was significantly associated with total sugars consumption. However, variation in intakes of sugars explained only a modest amount of variation in urinary sugars excretion. In the unadjusted models, fructose intake explained 24.3% of urinary fructose excretion, and intake of total sugars explained 16.3% of the sum of urinary fructose and sucrose. The adjusted models explained 44.3% of urinary fructose excretion and 41.7% of the sum of urinary fructose and sucrose. Therefore, we caution using these biomarkers to predict sugars consumption before other factors that determine urinary sugars excretion are understood.",2013,The adjusted models explained 44.3% of urinary fructose excretion and 41.7% of the sum of urinary fructose and sucrose.,[],['2 analytical methods (gas chromatography [GC] and enzymatic reactions-UV absorption'],"['24-hour urinary fructose excretion', 'total sugars consumption', 'urinary sucrose and fructose excretion', 'urinary fructose excretion, and intake of total sugars', '24-hour urinary fructose and sucrose']",[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0008555', 'cui_str': 'Gas Chromatography'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]",53.0,0.0247039,The adjusted models explained 44.3% of urinary fructose excretion and 41.7% of the sum of urinary fructose and sucrose.,"[{'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. Electronic address: xsong2@fhcrc.org.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': ''}, {'ForeName': 'Pho', 'Initials': 'P', 'LastName': 'Diep', 'Affiliation': ''}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Elena C', 'Initials': 'EC', 'LastName': 'Razmpoosh', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schwarz', 'Affiliation': ''}, {'ForeName': 'Ching-Yun', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': ''}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': ''}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': ''}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2013.05.017']
921,24807748,Blind versus fluoroscopy-guided percutaneous nephrolithotomy: a randomized clinical trial.,"PURPOSE


Due to the negative impact of radiation on the patient and the surgical team during percutaneous nephrolithotomy (PCNL), we aimed to evaluate success rate and complications of blind access for PCNL using lumbar notch landmark and compare with conventional fluoroscopy-guided access.
MATERIALS AND METHODS


In a clinical trial, 100 patients who were candidate for PCNL, were randomly assigned into blind group (1) and fluoroscopy-guided group (2). In group 1 the lumbar notch was used to guide percutaneous access and in group 2 fluoroscopy performed after needle insertion, Amplatz placement and at the end of surgery. If the access failed, we would repeat puncturing up to 5 times. In group 2, access was achieved using full fluoroscopy guidance. All patients underwent postoperative assessment including kidney-ureter-bladder X-ray and ultrasonography.
RESULTS


Both mean access time and mean operation time were statically similar in group 1 and group 2 (3.3 ± 0.5 vs. 3.6 ± 0.7 min and 35.2 ± 4.6 vs. 38.9 ± 4.1 min, respectively). A successful puncture was achieved in 86% and 94% of the patients in groups 1 and 2, respectively (P = .18). Total success rate of procedure was 80% and 88% of the patients in groups 1 and 2, respectively (P = .27).
CONCLUSION


According to this study, it seems that blind access is a safe and effective PCNL method, and we recommend employment of this technique by skilled endourologist in urology centers especially for patient with large hydronephrotic kidney.",2014,"A successful puncture was achieved in 86% and 94% of the patients in groups 1 and 2, respectively (P = .18).","['100 patients who were candidate for PCNL', 'patient with large hydronephrotic kidney']","['conventional fluoroscopy-guided access', 'percutaneous nephrolithotomy (PCNL', 'postoperative assessment including kidney-ureter-bladder X-ray and ultrasonography', 'fluoroscopy-guided percutaneous nephrolithotomy', 'fluoroscopy-guided group']","['successful puncture', 'mean access time and mean operation time', 'Total success rate of procedure']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0041951', 'cui_str': 'Ureter'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",100.0,0.0641436,"A successful puncture was achieved in 86% and 94% of the patients in groups 1 and 2, respectively (P = .18).","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Urology and Nephrology Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. karami_hosein@yahoo.com.'}, {'ForeName': 'Mohammad Mohsen', 'Initials': 'MM', 'LastName': 'Mazloomfard', 'Affiliation': 'Department of Urology, Medical Laser Application Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mazloomfard@yahoo.com.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Moeini', 'Affiliation': 'Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Mohammadhosseini', 'Affiliation': 'Urology and Nephrology Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. drmohammadhosseini@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rezaei', 'Affiliation': 'Urology and Nephrology Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences,Tehran,Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Lotfi', 'Affiliation': 'Department of Urology, Medical Laser Application Research Center, Shohadae Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Urology journal,[]
922,24329696,Estrogen can modulate menopausal women's heart rate variability.,"The aim of our study was to compare the responses of heart rate variability (HRV) with two different types of hormonal substitution therapy (HT) in post-menopausal women (cross-sectional study) and to reveal an effect of HT shortly after beginning of its administration (follow-up study). To elucidate the influence of menopause and effects of different protocols of a HT on autonomic control of heart rate, we evaluated the heart rate variability (HRV) in 5 groups: premenopausal women (n=140), postmenopausal women without HT (n=360), women on HT with conjugated estrogen only (n=168), women on continuous combined estrogen-progesterone HT (n=117), and men (n=140). Frequency-domain of short-term stationary R-R intervals was performed to evaluate the total variance, low frequency power (LF; 0.04-0.15 Hz), high frequency power (HF; 0.15-0.40 Hz), portion of low frequency power (LF%) and ratio of LF to HF (LF/HF). Significantly lower portion of the LF was found in premenopausal women [46.9 (+/-2.7) nu] when compared to untreated postmenopausal women [54.3 (+/-2.9) nu] and men [55.2 (+/-3.0) nu]. Treatment by estrogen only was proved to decrease the LF% [40.1 (+/-2.1) nu] while no effect on HRV was observed in women treated with combination of estrogen and progesterone [57.2 (+/-3.1) nu]. Also the HF was lower in postmenopausal women [4.16 (+/-0.16) ms(2)] than in premenopausal women [4.79 (+/-0.22) ms(2)] and women treated with estrogen only [4.98 (+/-0.25) ms(2)] while in women treated with combined hormonal therapy the average value [3.99 (+/-0.21) ms(2)] did not significantly differ from that of untreated postmenopausal women. The follow-up study also proved increase of high frequency power already after two months of estrogen substitution therapy [4.86 (+/-0.14) ms(2) vs. 4.19 (+/-0.15) ms(2)]. These results suggest that higher vagal modulation of heart rate that seems typical for younger women becomes after menopause similar to that of men. We also proved a positive shift of HRV parameters toward more beneficial values as for a cardiovascular risk in postmenopausal women treated with estrogens but not in those treated by combined estrogen - progesterone substitution therapy.",2013,Also the HF was lower in postmenopausal women [4.16 (+/-0.16) ms(2)] than in premenopausal women [4.79 (+/-0.22) ms(2)],"['postmenopausal women', '5 groups: premenopausal women (n=140), postmenopausal women without HT (n=360), women on HT with conjugated estrogen only (n=168), women on', 'n=117), and men (n=140', 'post-menopausal women (cross-sectional study']","['combined hormonal therapy', 'Estrogen', 'continuous combined estrogen-progesterone HT', 'hormonal substitution therapy (HT']","['autonomic control of heart rate', 'HRV', 'heart rate', 'LF', 'heart rate variability (HRV', 'Frequency-domain of short-term stationary R-R intervals']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014938', 'cui_str': 'conjugated estrogens'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0317794,Also the HF was lower in postmenopausal women [4.16 (+/-0.16) ms(2)] than in premenopausal women [4.79 (+/-0.22) ms(2)],"[{'ForeName': 'S-G', 'Initials': 'SG', 'LastName': 'Yang', 'Affiliation': 'Institute of Physiology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. otomar.kittnar@staff.cuni.cz.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mlček', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Kittnar', 'Affiliation': ''}]",Physiological research,[]
923,24078509,Autologous fibrin sealant in tubeless percutaneous nephrolithotomy; a prospective study.,"PURPOSE


To evaluate the efficacy of autologous single-donor fibrin glue after tubeless percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS


Forty-three patients were planned for tubeless PCNL in a prospective cohort study and randomized in two groups with or without using fibrin glue. Randomization method was based on the computer-generated random numbers.
RESULTS


Transfusion, urinary leakage, or major complications were found in neither of the groups. There was no difference between two groups in stone free rate (P = .53), and changes in hemoglobin (P = .61) and serum creatinine (P = .63) level.
CONCLUSION


Although autologous fibrin glue did not play any significant role in improving results or decreasing complications after tubeless PCNL in our study, its use was safe and did not increase complications.",2013,"There was no difference between two groups in stone free rate (P = .53), and changes in hemoglobin (P = .61) and serum creatinine (P = .63) level.
CONCLUSION


","['tubeless percutaneous nephrolithotomy', 'Forty-three patients were planned for']","['Autologous fibrin sealant', 'fibrin glue', 'autologous single-donor fibrin glue after tubeless percutaneous nephrolithotomy (PCNL', 'tubeless PCNL', 'autologous fibrin glue']","['Transfusion, urinary leakage, or major complications', 'changes in hemoglobin', 'serum creatinine', 'stone free rate']","[{'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",43.0,0.0179847,"There was no difference between two groups in stone free rate (P = .53), and changes in hemoglobin (P = .61) and serum creatinine (P = .63) level.
CONCLUSION


","[{'ForeName': 'Seyyed Amir Mohsen', 'Initials': 'SA', 'LastName': 'Ziaee', 'Affiliation': 'Urology and Nephrology Research Center, No. 103, 9th Boustan St., Pasdaran Ave., Tehran, Iran. nouralizadeh@yahoo.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sarhangnejad', 'Affiliation': ''}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abolghasemi', 'Affiliation': ''}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Eshghi', 'Affiliation': ''}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Radfar', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahanian', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kardoust Parizi', 'Affiliation': ''}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Amirizadeh', 'Affiliation': ''}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Nouralizadeh', 'Affiliation': ''}]",Urology journal,[]
924,24091567,A validated risk model to predict 90-day VTE events in postsurgical patients.,"BACKGROUND


VTE is the proximate cause of 100,000 deaths in the United States each year. Perioperative VTE risk among surgical patients varies by 20-fold, which highlights the importance of risk stratification to identify high-risk patients, in whom chemoprophylaxis can decrease VTE risk, and low-risk patients, for whom the risk-benefit relationship of prophylaxis may be unfavorable.
METHODS


We used data from a statewide surgical quality collaborative for surgical procedures performed between 2010 and 2012. Regression-based techniques identified predictors of 90-day VTE while adjusting for procedural complexity and comorbid conditions. A weighted risk index was created and was validated subsequently in a separate, independent dataset.
RESULTS


Data were available for 10,344 patients, who were allocated randomly to a derivation or validation cohort. The 90-day VTE rate was 1.4%; 66.2% of the derivation cohort and 65.5% of the validation cohort received chemoprophylaxis. Seven risk factors were incorporated into a weighted risk index: personal history of VTE, current cancer, sepsis/septic shock/systemic inflammatory response syndrome, age≥60 years, BMI≥40 kg/m2, male sex, and family history of VTE. Prediction for 90-day VTE was similar in the derivation and validation cohorts (areas under the receiver operator curve, 0.72 and 0.70, respectively). An 18-fold variation in 90-day VTE rate was identified.
CONCLUSIONS


A weighted risk index quantifies 90-day VTE risk among surgical patients and identifies an 18-fold variation in VTE risk among the overall surgical population.",2014,"Prediction for 90-day VTE was similar in the derivation and validation cohorts (areas under the receiver operator curve, 0.72 and 0.70, respectively).","['Data were available for 10,344 patients', 'postsurgical patients']",['chemoprophylaxis'],"['90-day VTE', 'Perioperative VTE risk', '90-day VTE rate']","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0512309,"Prediction for 90-day VTE was similar in the derivation and validation cohorts (areas under the receiver operator curve, 0.72 and 0.70, respectively).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Pannucci', 'Affiliation': 'Section of Plastic Surgery, Ann Arbor, MI.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Laird', 'Affiliation': 'Michigan Surgical Quality Collaborative, Ann Arbor, MI.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Dimick', 'Affiliation': 'Division of Minimally Invasive Surgery, Ann Arbor, MI.'}, {'ForeName': 'Darrell A', 'Initials': 'DA', 'LastName': 'Campbell', 'Affiliation': 'University of Michigan Hospitals, Ann Arbor, MI.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Henke', 'Affiliation': 'Section of Vascular Surgery, Ann Arbor, MI. Electronic address: henke@med.umich.edu.'}]",Chest,['10.1378/chest.13-1553']
925,32089006,Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment in the ODYSSEY phase 3 trials with alirocumab.,"AIMS


Guidelines recommend targeting non-high-density lipoprotein cholesterol to reduce cardiovascular risk. We assessed the impact of baseline triglycerides on non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n  = 4983).
METHODS


Trials were grouped into four pools based on alirocumab dose (75-150 mg every 2 weeks), control (placebo/ezetimibe) and statin use. Baseline triglyceride quintiles were built within each pool. Non-high-density lipoprotein cholesterol goal attainment (very high risk: <100 mg/dl; moderate/high risk: <130 mg/dl), low-density lipoprotein cholesterol goal attainment (very high risk: <70 mg/dl; moderate/high risk: <100 mg/dl) and changes from baseline in lipid parameters were assessed at Week 24 among baseline triglyceride quintiles.
RESULTS


Higher baseline triglycerides were associated with a worse cardiovascular risk profile. Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol increased with higher triglycerides, but the magnitude in non-high-density lipoprotein cholesterol was three- to four-fold higher compared with the increase in low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions from baseline with alirocumab were similar regardless of baseline triglycerides. A greater proportion of alirocumab-treated patients attained non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol goals compared with placebo or ezetimibe. Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests). A single standard deviation increase in baseline log(triglycerides) was significantly associated with lower odds ratios of attaining non-high-density lipoprotein cholesterol goals in the different pools and treatment (alirocumab/placebo/ezetimibe) groups, unlike low-density lipoprotein cholesterol goal attainment.
CONCLUSION


Individuals with increased triglycerides have higher non-high-density lipoprotein cholesterol levels and lower rates of non-high-density lipoprotein cholesterol goal attainment (unlike low-density lipoprotein cholesterol goal attainment). Alirocumab improves non-high-density lipoprotein cholesterol goal attainment in this population. These results highlight the impact of triglycerides on non-high-density lipoprotein cholesterol and the need for novel therapies targeting triglyceride-related pathways.",2020,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).",['non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n \u2009=\u20094983'],"['placebo/ezetimibe', 'placebo or ezetimibe', 'control (placebo/ezetimibe) and statin use', 'Alirocumab']","['Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment', 'Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol', 'density lipoprotein cholesterol', 'Baseline triglyceride quintiles', 'baseline log(triglycerides', 'Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment', 'non-high-density lipoprotein cholesterol goal attainment', 'low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions', 'cardiovascular risk profile', 'low-density lipoprotein cholesterol goal attainment']","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.416905,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).","[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Vallejo-Vaz', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'Li Ka Shing Knowledge Institute, University of Toronto, Canada.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Italy.'}, {'ForeName': 'Marja-Riitta', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': 'Cardiovascular Research Unit, University of Helsinki, Finland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, German.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mandel', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Samuel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., USA.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}]",European journal of preventive cardiology,['10.1177/2047487320905185']
926,32421513,Adolescents' Acceptance of Long-Acting Reversible Contraception After an Educational Intervention in the Emergency Department: A Randomized Controlled Trial.,"INTRODUCTION


Adolescents who seek care in the emergency department (ED) are a cohort at increased risk of unintended pregnancy. Although adolescents are interested in learning about pregnancy prevention in the ED, there is a lack of effective educational interventions in this setting. Long-acting reversible contraceptives (LARC) are highly effective and safe in teens, yet are underutilized. This study assessed contraception use among adolescents in the ED and evaluated the impact of an educational video on their interest in and uptake of LARCs.
METHODS


We conducted a two-arm randomized controlled trial on a convenience sample of sexually active females 14 to 21 years old in an urban pediatric ED. Participants were randomized to an educational video or standard care. All participants completed a survey and were given an informational card about affiliated teen clinics with the option to schedule an appointment. We assessed pre-post mean differences between control and intervention participants and pre-post differences among intervention participants. Participants were followed three months after their ED visit to examine use of contraception.
RESULTS


A total of 79 females were enrolled (42 control and 37 intervention). The mean age was 17 years, and most were youth of color. The proportion of participants with a prior pregnancy was 18%. Almost all participants reported wanting to avoid pregnancy, yet 18% reported not using contraception at last intercourse. At baseline, 17.7% of participants were somewhat or very interested in the intrauterine device (IUD) or implant. After watching the video, 42.3% were somewhat or very interested in the IUD and 35.7% in the implant. Among those who watched the video, there were significant increases in interest in using an IUD or implant (p<.001). Compared to controls, adolescents who watched the video were also significantly more likely to report wanting an IUD (p<0.001) or implant (p=0.002). A total of 46% were reached for follow-up. Of these, 16% had initiated a LARC method after their ED visit (p=NS).
CONCLUSION


Most adolescent females in the ED want to avoid pregnancy, but are using ineffective methods of contraception. A brief educational video on LARCs was acceptable to adolescents and feasible to implement in a busy urban ED setting. Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.",2020,"Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.","['The mean age was 17 years, and most were youth of color', 'A total of 79 females were enrolled (42 control and 37 intervention', 'convenience sample of sexually active females 14 to 21 years old in an urban pediatric ED', 'Adolescents who seek care in the emergency department (ED']","['educational video or standard care', 'Long-acting reversible contraceptives (LARC', 'Educational Intervention']","['actual adoption of contraception', 'report wanting an IUD', 'wanting to avoid pregnancy', ""Adolescents' Acceptance of Long-Acting Reversible Contraception""]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}]",79.0,0.153725,"Adolescents who watched the video had significantly greater interest in using LARCs, but no demonstrated change in actual adoption of contraception.","[{'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Vayngortin', 'Affiliation': ""Rady Children's Hospital, University of California San Diego, Division of Emergency Medicine, San Diego, California.""}, {'ForeName': 'Lela', 'Initials': 'L', 'LastName': 'Bachrach', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital Oakland, Department of Adolescent Medicine, Oakland, California.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital Oakland, Department of Emergency Medicine, Oakland, California.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tebb', 'Affiliation': 'University of California San Francisco, Department of Adolescent Medicine, San Francisco, California.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.2.45433']
927,31362007,Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding.,"BACKGROUND & AIMS


It is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (≥2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding.
METHODS


We performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n = 119) or no clip (control, n = 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy.
RESULTS


In the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, -14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, -4.3% to 17.9%).
CONCLUSIONS


In a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure. ClinicalTrials.gov ID: NCT02765022.",2019,"Delayed bleeding occurred in 14 patients in the control group (12.1%) and in 6 patients in the clip group (5%) (absolute risk difference, reduction of 7% in the clip group; 95% CI, -14.7% to 0.3%).","['patients with LNPCLs undergoing', 'patients with an estimated average or high risk of delayed bleeding', '11 hospitals in Spain, from May 2016 through June 2018, of 235 consecutive patients who underwent EMR for LNPCLs with an average or high risk or delayed bleeding (based on Spanish endoscopy society endoscopic resection group score']","['complete clip closure of large (≥2 cm) large nonpedunculated colorectal lesions (LNPCLs', 'colonic endoscopic mucosal resection (EMR', 'Clip Closure', 'closure of the scar with 11 mm through the scope clips (n=119) or no clip', 'EMR']","['proportion of patients in each group with delayed bleeding', 'complete closure', 'Delayed bleeding', 'delayed bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C1700928', 'cui_str': 'Endoscopic Mucous Membrane Resection'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",235.0,0.110748,"Delayed bleeding occurred in 14 patients in the control group (12.1%) and in 6 patients in the clip group (5%) (absolute risk difference, reduction of 7% in the clip group; 95% CI, -14.7% to 0.3%).","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Albéniz', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: edualbeniz@hotmail.com.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Álvarez', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jorge C', 'Initials': 'JC', 'LastName': 'Espinós', 'Affiliation': 'Hospital Universitari Mútua Terrassa, Barcelona, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nogales', 'Affiliation': 'Hospital Gregorio Marañon, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guarner', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Alonso', 'Affiliation': 'Hospital Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Téllez', 'Affiliation': 'Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Herreros de Tejada', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Santiago', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Madrid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bustamante-Balén', 'Affiliation': 'Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Rodríguez Sánchez', 'Affiliation': 'Hospital General de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Ramos-Zabala', 'Affiliation': 'Hospital Universitario HM Montepríncipe, HM Hospitales, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Valdivielso', 'Affiliation': 'Hospital Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Martínez-Alcalá', 'Affiliation': 'Clinica de Gastroenterología Integral, Sevilla, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fraile', 'Affiliation': 'Hospital San Pedro de Logroño, Logroño, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Elosua', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'María Fernanda', 'Initials': 'MF', 'LastName': 'Guerra Veloz', 'Affiliation': 'Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Ibáñez Beroiz', 'Affiliation': 'Navarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Red de Investigación en Servicios Sanitarios y Enfermedades Crónicas, Pamplona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Navarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Enguita-Germán', 'Affiliation': 'Navarrabiomed, Universidad Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}]",Gastroenterology,['10.1053/j.gastro.2019.07.037']
928,32422214,Clinical peri-implant health and biological bone marker levels in tobacco users treated with photodynamic therapy.,"BACKGROUND


What impact does tobacco smoking have on photodynamic therapy (PDT) outcome is still unknown. The aim of the present clinical trial was to evaluate the clinical, radiographic, and biological bone markers after provision of PDT in cigarette, e-cigarette, and never-smokers with peri-implantitis (PI) at 6 months post treatment.
MATERIALS AND METHODS


Twenty-five healthy patients with PI were divided into three groups: Group I: cigarette smokers; Group II: e-cigarettes users; Group III: never-smokers. Full-mouth mechanical debridement with adjunctive methylene blue-mediated PDT was performed. Clinical recordings included peri-implant plaque index (Pi), bleeding on probing (BOP) and probing depth (PD). Peri-implant sulcular fluid was collected for the assessment of biological bone biomarkers including receptor activator of nuclear factor-ligand (RANK-L) and osteoprotegrin (OPG). All assessments were performed at baseline, 3 months and 6 months. P-value of <0.05 was considered significant.
RESULTS


BOP in Group II and III significantly reduced at 3 months (p < 0.05). Group I showed significant reduction only at 6 months (p < 0.05). Mean PD showed no statistically significant difference between the groups at any time-point. Inter-group comparison showed Group III demonstrating statistically significantly reduced mean RANK-L levels at both 3 and 6 months (p < 0.05). A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
CONCLUSION


Adjunctive PDT helped in reducing the clinical peri-implant inflammation. However, no significant change was observed for biological bone biomarkers among tobacco smokers.",2020,"A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
","['tobacco users treated with', 'Twenty-five healthy patients with PI', 'cigarette, e-cigarette, and never-smokers with peri-implantitis (PI']","['photodynamic therapy', 'cigarette smokers; Group II: e-cigarettes users; Group III: never-smokers', 'adjunctive methylene blue-mediated PDT']","['mean RANK-L levels', 'OPG levels', 'clinical peri-implant inflammation', 'peri-implant plaque index (Pi), bleeding on probing (BOP) and probing depth (PD', 'Mean PD', 'biological bone biomarkers']","[{'cui': 'C3853727', 'cui_str': 'Tobacco user'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",25.0,0.0122046,"A slight increase in the OPG levels were observed at 3 months and followed by a slight decrease at 6 months for all the study groups when compared with baseline values, however, these values did not show statistical significance (p > 0.05).
","[{'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'Al Deeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alresayes', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'A Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Aasem M', 'Initials': 'AM', 'LastName': 'Alhenaki', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'AlHelal', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh 11545, Saudi Arabia; Research Chair for Biological Research in Dental Health, College of Dentistry, Riyadh 11545, Saudi Arabia. Electronic address: tajabbar@ksu.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101821']
929,3611169,Biodegradable internal fixation for malleolar fractures. A prospective randomised trial.,"Fifty-six patients with displaced malleolar fractures had open reduction and fixation of the fracture fragments using, by random selection, either biodegradable implants or metal AO plates and screws. The cylindrical biodegradable implants were made of polylactide-glycolide copolymer (polyglactin 910). The complications, radiographic results and functional recovery were studied prospectively. After follow-up of at least one year, no significant differences emerged in the complication rate or in the results of treatment between the two methods of fixation. Because of the advantage of avoiding the need to remove metal fixation after union, we now use biodegradable internal fixation routinely to treat displaced malleolar fractures.",1987,"After follow-up of at least one year, no significant differences emerged in the complication rate or in the results of treatment between the two methods of fixation.",['Fifty-six patients with displaced malleolar fractures'],['biodegradable implants or metal AO plates and screws'],"['complications, radiographic results and functional recovery', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}]","[{'cui': 'C0600551', 'cui_str': 'Bioabsorbable Implants'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0185302,"After follow-up of at least one year, no significant differences emerged in the complication rate or in the results of treatment between the two methods of fixation.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Böstman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vainionpää', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hirvensalo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mäkelä', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vihtonen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Törmälä', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rokkanen', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
930,22569355,Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.,"OBJECTIVES


Piperacillin is often used in preterm infants for intra-abdominal infections; however, dosing has been derived from small single-center studies excluding extremely preterm infants at a highest risk for these infections. We evaluated the population pharmacokinetics (PK) of piperacillin using targeted sparse sampling and scavenged samples obtained from preterm infants ≤ 32 weeks of gestational age at birth and <120 postnatal days.
MATERIALS AND METHODS


A 5-center study was performed. A population PK model using nonlinear mixed effect modeling was developed. Covariate effects were evaluated based on the estimated precision and clinical significance.
RESULTS


Fifty-six preterm infants were evaluated and had a median (range) gestational age at birth of 25 (22-32) weeks, a postnatal age of 17 (1-77) days, a postmenstrual age of 29 (23-40) weeks, and a weight of 867 (400-2580) g. The final PK data set contained 211 samples; 202/211 (96%) were scavenged from the discarded clinical specimens. Piperacillin population PK was best described by a 1-compartment model. The population mean clearance (CL) was derived by the equation CL (L/h) = 0.479 × (weight)(0.75) × 0.5/serum creatinine and using a volume of distribution (V) (L) of 2.91 × (weight). The relative standard errors around parameter estimates ranged from 13.7% to 32.2%. A trend toward increased CL was observed with increasing gestational age at birth; infants with serum creatinine ≥ 1.2 mg/dL had a 60% reduction in piperacillin CL. The majority (>70%) of infants did not meet predefined pharmacodynamic efficacy targets.
CONCLUSIONS


Scavenged PK sampling is a minimal-risk approach that can provide meaningful information related to the development of PK models but not dosing recommendations for piperacillin. The utility of scavenged sampling in providing definitive dosing recommendations may be drug dependent and needs to be further explored.",2012,The population mean clearance (CL) was derived by the equation CL (L/h) = 0.479 × (weight)(0.75) × 0.5/serum creatinine and using a volume of distribution (V) (L) of 2.91 × (weight).,"['preterm infants ≤ 32 weeks of gestational age at birth and <120 postnatal days', 'preterm infants for intra-abdominal infections', 'preterm infants', 'Fifty-six preterm infants were evaluated and had a median (range) gestational age at birth of 25 (22-32) weeks, a postnatal age of 17 (1-77) days, a postmenstrual age of 29 (23-40) weeks, and a weight of 867 (400-2580']","['Piperacillin', 'piperacillin']","['CL', 'population mean clearance (CL', 'piperacillin CL']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0031955', 'cui_str': 'Piperacillin'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031955', 'cui_str': 'Piperacillin'}]",56.0,0.0819707,The population mean clearance (CL) was derived by the equation CL (L/h) = 0.479 × (weight)(0.75) × 0.5/serum creatinine and using a volume of distribution (V) (L) of 2.91 × (weight).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA. michael.cohenwolkowiez@duke.edu'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'Janice E', 'Initials': 'JE', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Zadell', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Angela D M', 'Initials': 'AD', 'LastName': 'Kashuba', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Ouellet', 'Affiliation': ''}]",Therapeutic drug monitoring,['10.1097/FTD.0b013e3182587665']
931,22386831,"The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo.","BACKGROUND


Previous gastrointestinal (GI) outcomes of nonsteroidal anti-inflammatory drug (NSAID) trials have focused on upper GI events, although recent evidence suggests NSAID-related lower GI effects are important and clinically relevant.
OBJECTIVE


We assessed the long-term GI adverse event (AE) profile of celecoxib in a nonarthritis population. The aim of this post hoc analysis was to determine the incidence of serious GI AEs, using a new Clinically Significant Upper and/or Lower GI Events end point.
METHODS


Patients from 2 colorectal adenoma recurrence studies were included. Patients received celecoxib 200 mg/400 mg BID, 400 mg once daily, or placebo over 3 years. The analysis measured noninferiority, using a prespecified definition of noninferiority. Celecoxib was predefined to be noninferior to placebo if the upper limit of the 95% CI for the hazard ratio (HR) with celecoxib was <1.25, at any dose, compared with the placebo (calculated using the Cox proportional hazards model).
RESULTS


A total of 3588 patients were included; in the primary analysis, the HR for celecoxib (any dose) compared with placebo was 1.22 (95% CI: 0.69-2.18; P = 0.4948). In the secondary dose analyses, the HR associated with a 400-mg daily dose, compared with placebo, was 1.04 (95% CI: 0.55-1.96; P = 0.9149); for 800 mg/d, the HR was 1.79 (95% CI: 0.82-3.89; P = 0.1427). In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs. Study limitations include retrospective evaluation and small sample size of patients with GI AEs.
CONCLUSIONS


The noninferiority of celecoxib to placebo was not established because the HR for the time to the first Clinically Significant Upper and/or Lower GI Event was greater than the prespecified upper limit of 95% CI for noninferiority. In addition, HRs associated with daily doses of 400 or 800 mg celecoxib compared with placebo were not significant. However, a significantly increased risk of clinically significant upper and/or lower GI events was observed in low-dose aspirin users (≤162.5 mg average daily use) and in patients ≥65 years of age.",2012,"In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs.","['3588 patients', 'Patients from 2 colorectal adenoma recurrence studies were included', 'patients with GI AEs']","['Celecoxib', 'placebo', 'aspirin', 'nonsteroidal anti-inflammatory drug (NSAID', 'celecoxib and placebo', 'celecoxib']","['risk of GI AEs', 'risk of clinically significant upper and/or lower GI events', 'long-term GI adverse event (AE) profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3588.0,0.763527,"In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs.","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Arber', 'Affiliation': 'The Integrated Cancer Prevention Center, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. nadir@tasmc.health.gov.il'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lieberman', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Sands', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ''}, {'ForeName': 'Ernest T', 'Initials': 'ET', 'LastName': 'Hawk', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Eagle', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Coindreau', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Zauber', 'Affiliation': ''}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lanas', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2012.02.001']
932,22938706,Tiotropium in asthma poorly controlled with standard combination therapy.,"BACKGROUND


Some patients with asthma have frequent exacerbations and persistent airflow obstruction despite treatment with inhaled glucocorticoids and long-acting beta-agonists (LABAs).
METHODS


In two replicate, randomized, controlled trials involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, we compared the effect on lung function and exacerbations of adding tiotropium (a total dose of 5 μg) or placebo, both delivered by a soft-mist inhaler once daily for 48 weeks. All the patients were symptomatic, had a post-bronchodilator forced expiratory volume in 1 second (FEV(1)) of 80% or less of the predicted value, and had a history of at least one severe exacerbation in the previous year.
RESULTS


The patients had a mean baseline FEV(1) of 62% of the predicted value; the mean age was 53 years. At 24 weeks, the mean (±SE) change in the peak FEV(1) from baseline was greater with tiotropium than with placebo in the two trials: a difference of 86±34 ml in trial 1 (P=0.01) and 154±32 ml in trial 2 (P<0.001). The predose (trough) FEV(1) also improved in trials 1 and 2 with tiotropium, as compared with placebo: a difference of 88±31 ml (P=0.01) and 111±30 ml (P<0.001), respectively. The addition of tiotropium increased the time to the first severe exacerbation (282 days vs. 226 days), with an overall reduction of 21% in the risk of a severe exacerbation (hazard ratio, 0.79; P=0.03). No deaths occurred; adverse events were similar in the two groups.
CONCLUSIONS


In patients with poorly controlled asthma despite the use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov numbers, NCT00772538 and NCT00776984.).",2012,"The predose (trough) FEV(1) also improved in trials 1 and 2 with tiotropium, as compared with placebo: a difference of 88±31 ml (P=0.01) and 111±30 ml (P<0.001), respectively.","['912 patients with asthma who were receiving', 'patients had a mean baseline FEV(1) of 62% of the predicted value; the mean age was 53 years']","['placebo', 'inhaled glucocorticoids and LABAs', 'tiotropium', 'inhaled glucocorticoids', 'Tiotropium']","['time to the first severe exacerbation', 'predose (trough) FEV(1', 'lung function and exacerbations', 'post-bronchodilator forced expiratory volume in 1 second (FEV(1', 'deaths occurred; adverse events', 'mean (±SE) change in the peak FEV(1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",912.0,0.676817,"The predose (trough) FEV(1) also improved in trials 1 and 2 with tiotropium, as compared with placebo: a difference of 88±31 ml (P=0.01) and 111±30 ml (P<0.001), respectively.","[{'ForeName': 'Huib A M', 'Initials': 'HA', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen and the Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands. h.a.m.kerstjens@umcg.nl'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Dahl', 'Affiliation': ''}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Paggiaro', 'Affiliation': ''}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vandewalker', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sigmund', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seibold', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Moroni-Zentgraf', 'Affiliation': ''}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bateman', 'Affiliation': ''}]",The New England journal of medicine,[]
933,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND


No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
METHODS


We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656.
FINDINGS


Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
INTERPRETATION


In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
FUNDING


Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9']
934,32423730,CPAP Effects on Oxygen Delivery in One-Lung Ventilation During Minimally Invasive Surgical Ablation for Atrial Fibrillation in The Supine Position.,"OBJECTIVE


In minimally invasive surgical ablation for atrial fibrillation during video-assisted thoracoscopy surgery, one-lung ventilation (OLV) with a double- lumen tube is commonly employed. In contrast with the majority of thoracic procedures, the patient lies supine; thus, the protective effect of gravity is lost and intrapulmonary shunt remains high. To decrease intrapulmonary shunt and to increase oxygenation, many strategies are utilized: high inspiratory fraction of oxygen (F I O 2 ), positive end-expiratory pressure on the ventilated lung, and continuous positive airway pressure (CPAP) on the deflated lung.
DESIGN


The authors performed a prospective, single- center, randomized study to evaluate the effect of additional CPAP in the nonventilated lung on oxygen delivery during surgical ablation for atrial fibrillation via video-assisted thoracoscopy in the supine position.
SETTING


University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy.
PARTICIPANTS


Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation.
INTERVENTIONS


The patients underwent pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2  constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O. During OLV, inspiratory pressure was reduced to obtain a tidal volume of 5 mL/kg, maintaining F I O 2  of 1.0, a respiratory rate to maintain PaCO 2  between 35 and 40 mmHg with capnothorax of 10 cmH 2 O. The patients were then randomized into the CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP group. Inotropic agents (dopamine or dobutamine) were used if cardiac index fell below 1.5 L/min/m 2 .
MEASUREMENTS AND MAIN RESULTS


Twenty-two patients were enrolled, randomized, and completed the study. Median age was 62 years. The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16. Cardiac index progressively increased during OLV until the end of the procedure in both groups (p < 0.01) and was maintained above 1.5 mL/min/m 2  during the whole study time. Arterial oxygen content remained stable during the entire procedure in both groups (p = 0.27). Oxygen delivery index (DO 2 I) increased significantly during the procedure (p < 0.01); nevertheless, the difference in DO 2 I between the CPAP and NO CPAP group was nonsignificant (p = 0.61). Intrapulmonary shunt (Q s /Q t ) increased during OLV (p < 0.01 for the time effect) and remained high until total lung ventilation was reintroduced. No difference in Q s /Q t  was observed between the CPAP and NO CPAP groups (p = 0.98). Similarly, mean pulmonary artery pressure increased significantly during OLV and remained high at the end of the procedure in both groups (time effect p < 0.01).
CONCLUSIONS


During OLV for atrial fibrillation surgical ablation in the supine position, CPAP on the deflated lung seemed to be ineffective to reduce Q s /Q t  or to increase arterial partial pressure of oxygen and DO 2 I, provided cardiac output was maintained above 1.5 L/min/m 2 .",2020,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","['One-Lung Ventilation', 'Twenty-two patients scheduled for minimally invasive surgical ablation for atrial fibrillation', 'University hospital Centro Cardiologico Monzino IRCCS, Milano, Italy', 'Twenty-two patients', 'Median age was 62 years']","['additional CPAP', 'CPAP group (CPAP 10 cmH 2 0 on deflated lung) and NO CPAP', 'video-assisted thoracoscopy surgery, one-lung ventilation (OLV', 'pressure-controlled ventilation, adjusting inspiratory pressure to obtain a tidal volume of 7 mL/kg while keeping F I O 2  constantly 1.0, a respiratory rate to maintain arterial partial pressure of carbon dioxide (PaCO 2 ) between 35 and 40 mmHg, and positive end-expiratory pressure of 5 cmH 2 O', 'CPAP', 'Inotropic agents (dopamine or dobutamine', 'minimally invasive surgical ablation']","['Arterial oxygen content', 'Cardiac index', 'Oxygen delivery index', 'Q s /Q', 'mean pulmonary artery pressure', 'arterial partial pressure of oxygen and DO 2 I, provided cardiac output', 'Oxygen Delivery', 'arterial partial pressure of oxygen']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C2923055', 'cui_str': 'Video assisted thoracoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",22.0,0.0544509,"The difference in arterial partial pressure of oxygen between the 2 groups was shy of significance, p = 0.16.","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy. Electronic address: Camilla.lacqua@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Meli', 'Affiliation': ""Department of Medical Surgical Pathophysiology and Organ Transplantation, Universita' Degli Studi Di Milano Statale, Milano, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rondello', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Polvani', 'Affiliation': 'Department of Cardiac Surgery, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Salvi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Centro Cardiologico Monzino IRCCS, Milano, Italy.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.064']
935,32424045,C-reactive protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation.,"BACKGROUND


Antibiotics are prescribed to >70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a C-reactive protein point-of-care test (CRP-POCT) management strategy for AECOPD in primary care resulted in a 20% reduction in patient-reported antibiotic consumption over 4 weeks.
AIM


To understand perceptions of the value of CRP-POCT for guiding antibiotic prescribing for AECOPD; explore possible mechanisms, mediators, and pathways to effects; and identify potential barriers and facilitators to implementation from the perspectives of patients and clinicians.
DESIGN AND SETTING


Qualitative process evaluation in UK general practices.
METHOD


Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study. Interviews were audio-recorded, transcribed, and analysed using framework analysis.
RESULTS


Patients and clinicians felt that CRP-POCT was useful in guiding clinicians' antibiotic prescribing decisions for AECOPD, and were positive about introduction of the test in routine care. The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients. Some clinicians thought the CRP-POCT should be routinely used in consultations for AECOPD; others favoured use only when there was decisional uncertainty. CRP-POCT cartridge preparation time and cost were potential barriers to implementation.
CONCLUSION


CRP-POCT-guided antibiotic prescribing for AECOPD had high acceptability, but commissioning arrangements and further simplification of the CRP-POCT need attention to facilitate implementation in routine practice.",2020,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","['Qualitative process evaluation in UK general practices', 'COPD exacerbations', 'Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study', 'patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD']","['C-reactive protein point-of-care test (CRP-POCT', 'C-reactive protein-guided antibiotic prescribing']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],20.0,0.0494891,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","[{'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Singh-Mehta', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gal', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Population Health and Environment Sciences, King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X709865']
936,4030862,Major ruptures of the rotator cuff. The results of surgical repair in 89 patients.,"Major ruptures of the rotator cuff were repaired in 89 patients over a six-year period, using an approach through the split deltoid muscle and the bed of the excised outer centimetre of the clavicle. Review of these patients showed that poor results were associated with larger cuff defects, with more pre-operative steroid injections and with pre-operative weakness of the deltoid muscle. A randomised prospective study showed that repair followed by splinting in abduction gave no better results than repair followed by resting the arm at the side. Excision of the coraco-acromial ligament was associated with worse results than leaving its divided halves in situ. Follow-up showed that the results continued to improve for two years after operation; their quality was maintained in patients less than 60 years old, but in those over 60 there was deterioration with time.",1985,"Follow-up showed that the results continued to improve for two years after operation; their quality was maintained in patients less than 60 years old, but in those over 60 there was deterioration with time.","['Major ruptures of the rotator cuff', '89 patients']",[],['Major ruptures of the rotator cuff'],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}]",89.0,0.0163849,"Follow-up showed that the results continued to improve for two years after operation; their quality was maintained in patients less than 60 years old, but in those over 60 there was deterioration with time.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Watson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
937,21342036,Adjuvant therapy for pancreas adenocarcinoma: where are we going?,"Evaluation of: Neoptolemos JP, Stocken DD, Bassi C et al. Adjuvant chemotherapy with fluorouracil plus folinic acid vs. gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA 304(10), 1073-1081 (2010). Over the last decade, adjuvant therapy in the treatment of resected pancreas adenocarcinoma has had its value established. Such treatment incrementally increases 5-year survivorship and delays time to tumor recurrence. The backbone of adjuvant therapy is the single-agent gemcitabine, based primarily on results from the Charité Onkologie Clinical (CONKO)-001 study. Based on the combined results of the European Study Group for Pancreas Cancer (ESPAC)-1 and ESPAC-3 trials, Neoptolemos and colleagues have established both bolus 5-fluorouracil and leucovorin and gemcitabine as standard options for resected pancreatic cancer. Gemcitabine remains the main standard therapy based on its ease of administration and a more favorable toxicity profile; however, there is now a clearly validated alternate option of 5-fluororuacil and leucovorin based on the results of ESPAC-3. Moving forward, the integration of novel cytotoxic and targeted agents into adjuvant therapy, along with refining the role of neoadjuvant therapy for patients with resectable pancreas cancer, will hopefully accrue a more substantial improvement in outcome for patients with resected pancreas adenocarcinoma.",2011,Such treatment incrementally increases 5-year survivorship and delays time to tumor recurrence.,"['patients with resected pancreas adenocarcinoma', 'patients with resectable pancreas cancer', 'pancreas adenocarcinoma', 'pancreatic cancer resection', 'JAMA 304(10), 1073-1081']","['Adjuvant chemotherapy with fluorouracil plus folinic acid vs. gemcitabine', '5-fluorouracil and leucovorin and gemcitabine', 'Gemcitabine', 'leucovorin']",['5-year survivorship and delays time to tumor recurrence'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038955'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.020615,Such treatment incrementally increases 5-year survivorship and delays time to tumor recurrence.,"[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Department of Medicine, Gastrointestinal Oncology Service, 1275 York Avenue, Box 324, New York, NY 10065, USA. oreillye@mskcc.org'}]",Expert review of anticancer therapy,['10.1586/era.10.232']
938,31537908,"Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.","BACKGROUND


Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
METHODS


In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.
RESULTS


BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
CONCLUSIONS


BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
CLINICAL TRIAL REGISTRATION


NCT01735071 (Clinicaltrials.gov).",2019,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","['women with partially platinum-sensitive recurrent ovarian cancer', 'women progressing between 6 and 12 months since their last platinum-based therapy']","['BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin', 'bevacizumab', 'trabectedin and bevacizumab', 'bevacizumab and trabectedin with or without carboplatin']","['efficacy and safety', 'progression-free survival rate (PFS-6) and severe toxicity rate (ST-6']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.202843,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zaccarelli', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Baldoni', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Frezzini', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palluzzi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'UO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Università di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'AO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'ASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Negri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pesenti Gritti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gerardi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': ""D'Incalci"", 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}]",British journal of cancer,['10.1038/s41416-019-0584-5']
939,31448819,In reference to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['Dexmedetomidine', 'propofol']",[],[],"[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",[],,0.0388472,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Gobbi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Vito', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Meccariello', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giannicola', 'Initials': 'G', 'LastName': 'Iannella', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}]",The Laryngoscope,['10.1002/lary.28261']
940,31660644,Compliance with sedation analgesia protocols: Do clinical pharmacists have an impact?,"WHAT IS KNOWN AND OBJECTIVES


The agreement between prescribed sedation objectives and sedation pump syringe rate adaptation is not optimal. Delays in adjustment of sedation doses are associated with an increased patient length of stay in the intensive care unit. Our objectives were to assess compliance with the approved sedation protocol and to evaluate the impact of a clinical pharmacist daily controlling sedation and analgesia scores and pump syringe rates on patients' outcomes in a critical care unit.
METHODS


Prospective before/after study involving 60 adult patients divided into two groups (non-intervention and intervention groups) who received mechanical ventilation and continuous infusions of sedative and analgesic drugs in an intensive care unit. In both groups, data were collected daily in 30 mechanically ventilated patients receiving a sedation/analgesia regimen during a 3-month period according to a standardized protocol. A pharmacist was in charge of intervening with physicians when the local sedation analgesia protocol was not followed.
RESULTS AND DISCUSSION


There were no significant differences between the groups in terms of demographic characteristics except a higher proportion of men in the intervention group (70% vs 40%, P = .019). In the control group, sedation and analgesia objectives were not prescribed in more than half the cases. Pharmacist intervention reduced sedation duration (5 [2-11] vs 2 [1-5.5] days, P = .019). The cumulative delay in adaptation of the sedation analgesia electric syringe pump was significantly decreased in the intervention group (8 [0-29.5] vs 28.5 hours [11.1-68.4], P = .034). Total doses of sedatives (midazolam, propofol) and analgesics (sufentanil, remifentanil) per patient were decreased in the intervention group compared to the control group (respectively, P = .24, P = .0009, P = .0013 and P = .0007).
CONCLUSIONS


Pharmacist intervention can decrease the sedation duration and the total dose of sedation medications and reinforce adherence to sedation/analgesia guidelines.",2020,"There were no significant differences between the groups in terms of demographic characteristics except a higher proportion of men in the intervention group (70% vs 40%, P = .019).","['30 mechanically ventilated patients receiving a', '60 adult patients divided into two groups (non-intervention and intervention groups) who received', ""patients' outcomes in a critical care unit""]","['Pharmacist intervention', 'sedation/analgesia regimen', 'mechanical ventilation and continuous infusions of sedative and analgesic drugs', 'sedatives (midazolam, propofol) and analgesics (sufentanil, remifentanil']","['sedation duration', 'sedation and analgesia objectives', 'patient length of stay', 'cumulative delay in adaptation of the sedation analgesia electric syringe pump']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0181332', 'cui_str': 'Syringe pump (physical object)'}]",60.0,0.0512023,"There were no significant differences between the groups in terms of demographic characteristics except a higher proportion of men in the intervention group (70% vs 40%, P = .019).","[{'ForeName': 'Ophélie', 'Initials': 'O', 'LastName': 'Maison', 'Affiliation': 'Pharmacy, Groupement Hospitalier Sud, Pierre-Benite, France.'}, {'ForeName': 'Cléa', 'Initials': 'C', 'LastName': 'Tardy', 'Affiliation': 'Pharmacy, Groupement Hospitalier Sud, Pierre-Benite, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Offrey', 'Affiliation': 'Pharmacy, Groupement Hospitalier Sud, Pierre-Benite, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Boselli', 'Affiliation': 'Intensive care unit, Centre Hospitalier Pierre Oudot de Bourgoin-Jallieu, Bourgoin-Jallieu, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Piriou', 'Affiliation': 'Intensive care unit, Groupement Hospitalier Sud, Pierre-Benite, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Parat', 'Affiliation': 'Pharmacy, Groupement Hospitalier Sud, Pierre-Benite, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Allaouchiche', 'Affiliation': 'Intensive care unit, Groupement Hospitalier Sud, Pierre-Benite, France.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13023']
941,31409596,The Association of Fenofibrate with Kidney Tubular Injury in a Subgroup of Participants in the ACCORD Trial.,,2019,,[],['Fenofibrate'],[],[],"[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]",[],,0.0455193,,"[{'ForeName': 'Kinsuk', 'Initials': 'K', 'LastName': 'Chauhan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Girish N', 'Initials': 'GN', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Debnath', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Canada.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Coca', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; steven.coca@mssm.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.00370119']
942,31535360,An Overnight Stay Versus three Days Admission after Uncomplicated Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE


To evaluate the safety and efficacy of discharging patients on the first postoperative day after an uncomplicated percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS


after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day, we randomly assigned patients into two groups-Group 1: overnight surgery, and Group 2: routine discharge after three days. Patients with significant residual stone on control fluoroscopy were excluded. Ninety eight and 102 patients were assigned to groups 1 and 2, respectively. Serum Hemoglobin and Cr were evaluated before the operation as well as the first postoperative day. Stone free status was evaluated using ultrasound and KUB radiography at the first postoperative day.
RESULTS


The stone and patient characteristics were not different in two groups. The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups. Nine patients (9.2%) in Group 1 and five (4.9%) in Group 2 were readmitted because of complications (mainly hematuria) (p=.23). Of the readmitted patients, five in Group 1 (55%), and three in Group 2 (60%) received blood transfusion (p=.87). in these patients, group 1 received 1.6±0.51 units of blood compared with 1.93±0.25 in group 2 (p=.07). All the readmitted patients did well with conservative therapy with no need for angioembolization.
CONCLUSION


In uncomplicated PCNL with no significant residual stone, discharging the patient on the first postoperative day is safe. The outcome is comparable to a routine three-day hospital stay.",2020,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"['after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day', 'Patients with significant residual stone on control fluoroscopy were excluded', 'Ninety eight and 102 patients']","['overnight surgery, and Group 2: routine discharge', 'Overnight Stay Versus three Days Admission after uncomplicated Percutaneous Nephrolithotomy', 'uncomplicated percutaneous nephrolithotomy (PCNL']","['Serum Hemoglobin and Cr', 'blood transfusion', 'hemoglobin and creatinine levels', 'safety and efficacy']","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0356594,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Basiri@unrc.ir.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Department of Surgery, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. drdavoodarab@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Department of urology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran. h_pakmanesh@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Abedinzadeh', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. abedinoro@yahoo.com.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. hormozkarami@yahoo.com.'}]",Urology journal,['10.22037/uj.v0i0.5314']
943,31577396,Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm.,"BACKGROUND


Moderate therapeutic hypothermia is currently recommended to improve neurologic outcomes in adults with persistent coma after resuscitated out-of-hospital cardiac arrest. However, the effectiveness of moderate therapeutic hypothermia in patients with nonshockable rhythms (asystole or pulseless electrical activity) is debated.
METHODS


We performed an open-label, randomized, controlled trial comparing moderate therapeutic hypothermia (33°C during the first 24 hours) with targeted normothermia (37°C) in patients with coma who had been admitted to the intensive care unit (ICU) after resuscitation from cardiac arrest with nonshockable rhythm. The primary outcome was survival with a favorable neurologic outcome, assessed on day 90 after randomization with the use of the Cerebral Performance Category (CPC) scale (which ranges from 1 to 5, with higher scores indicating greater disability). We defined a favorable neurologic outcome as a CPC score of 1 or 2. Outcome assessment was blinded. Mortality and safety were also assessed.
RESULTS


From January 2014 through January 2018, a total of 584 patients from 25 ICUs underwent randomization, and 581 were included in the analysis (3 patients withdrew consent). On day 90, a total of 29 of 284 patients (10.2%) in the hypothermia group were alive with a CPC score of 1 or 2, as compared with 17 of 297 (5.7%) in the normothermia group (difference, 4.5 percentage points; 95% confidence interval [CI], 0.1 to 8.9; P = 0.04). Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3). The incidence of prespecified adverse events did not differ significantly between groups.
CONCLUSIONS


Among patients with coma who had been resuscitated from cardiac arrest with nonshockable rhythm, moderate therapeutic hypothermia at 33°C for 24 hours led to a higher percentage of patients who survived with a favorable neurologic outcome at day 90 than was observed with targeted normothermia. (Funded by the French Ministry of Health and others; HYPERION ClinicalTrials.gov number, NCT01994772.).",2019,"Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3).","['patients with nonshockable rhythms (asystole or pulseless electrical activity', 'From January 2014 through January 2018, a total of 584 patients from 25 ICUs underwent randomization, and 581 were included in the analysis (3 patients withdrew consent', 'adults with persistent coma after resuscitated out-of-hospital cardiac arrest', 'patients with coma who had been admitted to the intensive care unit (ICU) after resuscitation from cardiac arrest with nonshockable rhythm', 'patients with coma who had been resuscitated from cardiac arrest with nonshockable rhythm, moderate']",['moderate therapeutic hypothermia (33°C during the first 24 hours) with targeted normothermia'],"['survival with a favorable neurologic outcome', 'incidence of prespecified adverse events', 'Cerebral Performance Category (CPC) scale', 'Mortality', 'Mortality and safety', 'neurologic outcomes', 'alive with a CPC score', 'therapeutic hypothermia', 'favorable neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0222045'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}]",584.0,0.122199,"Mortality at 90 days did not differ significantly between the hypothermia group and the normothermia group (81.3% and 83.2%, respectively; difference, -1.9 percentage points; 95% CI, -8.0 to 4.3).","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Merdji', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grillet', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Girardie', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Coupez', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Brule', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pichon', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Landais', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Plantefeve', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Chakarian', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Sirodot', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Legriel', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Letheulle', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Thevenin', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Desachy', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Delahaye', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Botoc', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Vimeux', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Martino', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': ""From Médecine Intensive Réanimation, University Hospital Center, Nantes (J.-B.L., N.B., J.R.), the Paris Cardiovascular Research Center, INSERM Unité 970 (J.-B.L., A.C.), the Medical Intensive Care Unit, Cochin University Hospital Center (A.C.), and the AfterROSC Network (J.-B.L., A.C., N.P., S.L.), Paris, Université de Strasbourg, Faculté de Médecine (H.M.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Service de Médecine Intensive Réanimation (H.M.), and Unité Mixte de Recherche (UMR) 1260, Regenerative Nano Medecine, INSERM, Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg (H.M.), Strasbourg, INSERM Centres d'Investigation Clinique (CIC) 1415, Centre Hospitalier Régional Universitaire de Tours (A.L.G., B.G.), the Medical Intensive Care Unit, University Hospital Center (P.-F.D.), INSERM UMR 1100-Centre d'Etude des Pathologies Respiratoires, Tours University (P.-F.D.), and Université de Tours (B.G.), Tours, the Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon (G.C.), the Medical Intensive Care Unit, South Brittany General Hospital Center, Lorient (G.G.), Médecine Intensive Réanimation, Centre Hospitalier Universitaire Lille, and Université de Lille, Faculté de Médicine, Lille (P.G.), the Medical Intensive Care Unit, University Hospital Center, Clermond-Ferrand (E.C.), the Medical Intensive Care Unit, Regional Hospital Center, Orleans (T.B.), the Medical Intensive Care Unit, University Hospital Center, INSERM CIC 1402, Équipe ALIVE, and Université de Poitiers, Faculté de Médecine et de Pharmacie de Poitiers, Poitiers (J.-P.F.), the Medical Intensive Care Unit, University Hospital Center, Angers (P.A.), Service de Réanimation Polyvalente, University Hospital Center, and CIC 1435, University Hospital Center, Limoges (N.P.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Le Mans (M.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Argenteuil (G.P.), the Medical Intensive Care Unit, University Hospital Center, Dijon (J.-P.Q.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Roanne (J.-C.C.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Annecy (M.S.), the Medical-Surgical Intensive Care Unit, Versailles Hospital, Versailles (S.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Brieuc (J.L.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Lens (D.T.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Angouleme (A. Desachy), the Medical-Surgical Intensive Care Unit, General Hospital Center, Rodez (A. Delahaye), the Medical-Surgical Intensive Care Unit, General Hospital Center, Saint Malo (V.B.), the Medical-Surgical Intensive Care Unit, General Hospital Center, Montauban (S.V.), and the Medical Intensive Care Unit, University Hospital Center, Point-a-Pitre (F.M.) - all in France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1906661']
944,31170620,Internet-delivered treatment for young adults with anxiety and depression: Evaluation in routine clinical care and comparison with research trial outcomes.,"INTRODUCTION


Mood and anxiety disorders typically emerge in adolescence and early adult life, but young adults are often reluctant to seek treatment. The Mood Mechanic course is a transdiagnostic internet-delivered psychological intervention for symptoms of depression and anxiety, targeted at people aged 18-24 years. The current study compared the efficacy of the course when delivered under strict research trial conditions (research trial; n = 192) with its effectiveness in a routine health-care setting (routine care; n = 222).
METHODS


Symptoms of depression, anxiety and general distress at baseline, during, and after treatment were measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Kessler 10-Item Scale (K-10), respectively.
RESULTS


Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up. Deterioration rates were low, within-group effect sizes were large (>1.0) and both groups reported high levels of treatment satisfaction. Patients in routine care were less likely to complete post-treatment or follow-up symptom questionnaires.
LIMITATIONS


The study is based on self-reported data from treatment-seeking individuals that were motivated enough to start the course, and the absence of a control group and a formal diagnosis in the routine care sample means that some caution is needed in generalising the results.
CONCLUSION


The results show that the Mood Mechanic course is effective and acceptable in routine clinical care, and that online psychological interventions designed for young adults are an effective treatment option for this hard-to-reach group.",2019,Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up.,"['young adults with anxiety and depression', 'young adults']","['transdiagnostic internet-delivered psychological intervention', 'routine health-care setting (routine care; n\u202f=\u202f222']","['Deterioration rates', 'Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Kessler 10-Item Scale (K-10), respectively', 'depression, anxiety and general distress']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0398951,Both groups showed significant symptom reductions on all measures at post-treatment and 3-month follow-up.,"[{'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Staples', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia. Electronic address: lauren.staples@mq.edu.au.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Bareena', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fogliati', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Fogliati', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Nielssen', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.05.058']
945,2211767,The management of the painful first metatarsophalangeal joint in the older patient. Arthrodesis or Keller's arthroplasty?,"We report a prospective randomised trial comparing Keller's arthroplasty and arthrodesis of the first metatarsophalangeal joint for the management of symptomatic hallux valgus and hallux rigidus in the older patient. In 81 patients (110 feet), with a minimum of two years follow-up, both procedures gave a similar degree of patient satisfaction and symptom relief. The incidence of metatarsalgia was also similar. As there were no obvious advantages to arthrodesis, and since six out of 50 arthrodesed toes required revision, we suggest that Keller's arthroplasty is the better operation in these patients.",1990,"In 81 patients (110 feet), with a minimum of two years follow-up, both procedures gave a similar degree of patient satisfaction and symptom relief.",['older patient'],"[""Keller's arthroplasty and arthrodesis of the first metatarsophalangeal joint""]","['incidence of metatarsalgia', 'patient satisfaction and symptom relief']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal Joint'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0025587', 'cui_str': 'Metatarsalgia'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0298053,"In 81 patients (110 feet), with a minimum of two years follow-up, both procedures gave a similar degree of patient satisfaction and symptom relief.","[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': ""O'Doherty"", 'Affiliation': 'Leicester University, England.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Lowrie', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Magnussen', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Gregg', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
946,31327653,Rethinking results from the Japanese 23-valent pneumococcal polysaccharide vaccine randomized clinical trial.,"We review a previously published randomized clinical trial of 23-valent pneumococcal polysaccharide vaccine (PPSV23) that has been used extensively globally to support PPSV23 use among adults. We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population. As one example of internal data inconsistency, the values reported for the percent of all pneumonia cases due to pneumococcus and the vaccine efficacy (VE) for all cause pneumonia are mutually inconsistent, even based on unrealistically high values for PPSV23 VE against vaccine serotypes and the proportion of pneumococcal pneumonias due to vaccine serotypes.",2019,We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population.,[],['23-valent pneumococcal polysaccharide vaccine (PPSV23'],[],[],"[{'cui': 'C0305065', 'cui_str': 'Pneumococcal Polysaccharide Vaccine'}, {'cui': 'C0947642', 'cui_str': 'Pneumovax 23'}]",[],,0.137373,We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population.,"[{'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@pfizer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Theilacker', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jodar', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.07.040']
947,31909887,Pharmacokinetics of isoniazid in children with tuberculosis-A comparative study at two doses.,"AIM


To compare the pharmacokinetics of isoniazid (INH) at doses 5 and 10 mg/kg/day.
METHODS


INH concentrations were estimated by high-performance liquid chromatography in 24 Indian children aged 1 to 15 years on antituberculosis therapy. Blood samples were collected at 0, 2, 4, 6, 8 hours after administration of INH. Patients were randomly given INH at 5 or 10 mg/kg/day and maximum concentrations (C max  ) and area under the curve (AUC (0-8)  ) were determined in each group. The 2-hour concentration of INH was used as C max  for this study.
RESULTS


Mean (standard deviation) C max  was reached in 2 hours and was 2.68 ± 1.19 µg/mL in 5 mg/kg/day group and 8.86 ± 3.94 µg/mL in 10 mg/kg/day group (P < .05). The normal therapeutic range at 2-hour concentrations for INH in adults achieving good clinical response is between 3 and 5 µg/mL. Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max  higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max  within the 2-hour concentrations therapeutic range. The mean AUC (0-8)  in 5 mg/kg/day group was 10.04 ± 6.12 and 35.93 ± 25.37 µg·h/mL in 10 mg/kg/day group (P = .0001).
CONCLUSION


Children on daily INH 10 mg/kg/day have higher AUC and C max  than the required therapeutic range whereas over 65% of children with daily 5 mg/kg/day INH therapy failed to achieve the optimal therapeutic range.",2020,"Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max  higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max  within the 2-hour concentrations therapeutic range.","['children with tuberculosis', '24 Indian children aged 1 to 15 years on antituberculosis therapy']","['isoniazid (INH', 'isoniazid']","['Mean (standard deviation', 'mean AUC', 'Blood samples', 'INH concentrations', '2-hour concentration of INH', 'C max']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",24.0,0.0396882,"Among 5 mg/kg/day, only 4 (33%) patients had INH concentrations within the 2-hour concentrations therapeutic range whereas in 10 mg/kg/day group, 11 (91%) patients achieved C max  higher than the 2-hour concentrations therapeutic range and 1 (9%) patient had C max  within the 2-hour concentrations therapeutic range.","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'Sajal', 'Initials': 'S', 'LastName': 'Kumar Das', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'Naman S', 'Initials': 'NS', 'LastName': 'Shetty', 'Affiliation': 'Pediatric TB Clinic, Department of Pediatric Infectious Diseases, B J Wadia Hospital for Children, Mumbai, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kannan', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Ak Hemanth', 'Initials': 'AH', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Pharmacology, National Institute for Research in Tuberculosis, Chennai, India.'}]",Pediatric pulmonology,['10.1002/ppul.24624']
948,31843817,Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial.,"INTRODUCTION


Juvenile idiopathic arthritis (JIA) negatively affects adolescents' everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).
OBJECTIVES


To explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P-TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.
METHODS AND ANALYSIS


Recruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.
DISSEMINATION


Via journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.
TRIAL REGISTRATION NUMBER


ISRCTN13535901; Pre-results.",2019,"The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring.","['Irish adolescents with JIA', '60 families will be ongoing until July 2019, via healthcare professionals and support groups', 'adolescents with arthritis in Ireland']","['integrated iP2P and Irish TTC', 'Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management']","['self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs', 'feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring']","[{'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",60.0,0.171361,"The primary outcomes on feasibility with comparisons of TTC and iP2P-TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring.","[{'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': ""O'Higgins"", 'Affiliation': 'Centre for Pain Research, School of Psychology, National University of Ireland, Galway, Galway, Ireland siobhan.ohiggins@nuigalway.ie.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ahola Kohut', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Caes', 'Affiliation': 'Division of Psychology, Faculty of Natural Sciences, University of Stirling, Stirling, Scotland, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Heary', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'Centre for Pain Research, School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027952']
949,27933464,Can body composition be used to optimize the dose of platinum chemotherapy in lung cancer? A feasibility study.,"PURPOSE


Current methods of dosing platinum-based chemotherapy are suboptimal. Potentially, taking lean body mass into account may help. To inform the design of a future study, we first examined the feasibility and acceptability of such an approach using dual-energy X-ray absorptiometry (DEXA) and explored aspects suggestive of over- and under-dosing.
METHODS


Patients with lung cancer offered platinum-based chemotherapy over 1 year were identified and, if eligible, invited to take part in a prospective feasibility study. Questionnaires examined acceptability of the DEXA scan and of a future study that randomized between traditional dosing and one adjusted according to body composition. Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively.
RESULTS


Of the 173 patients offered chemotherapy, 123 (71%) were ineligible, mostly because of failing entry criteria (84, 49%). Of the 50 approached, 18 (36%) participated, most receiving carboplatin, with 17 providing data. All found a DEXA scan acceptable; other assessments were fully completed, except nadir and pre-chemotherapy blood counts. Most (94%) were prepared to take part in a future study, although the additional hospital visits for a nadir blood count were unpopular with some. Five (29%) patients experienced six episodes of DLT which resulted in discontinuation (3), dose reduction (2) or change to a less toxic regimen (1). Nine (60%) patients experienced either no (2) or inconsistent (7) neutropenia.
CONCLUSIONS


A randomized trial appears acceptable and feasible in patients receiving carboplatin. Adjustment of our entry criteria and avoiding a hospital visit for a nadir blood count should aid recruitment.",2017,"Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively.
","['173 patients offered chemotherapy, 123 (71%) were ineligible, mostly because of failing entry criteria (84, 49', 'Patients with lung cancer offered platinum-based chemotherapy over 1\xa0year', 'patients receiving']","['platinum-based chemotherapy', 'carboplatin', 'platinum chemotherapy', 'dual-energy X-ray absorptiometry (DEXA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",[],173.0,0.0204469,"Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively.
","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Bristow', 'Affiliation': 'Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Proffitt', 'Affiliation': 'Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Asmah', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Potter', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Hennig', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Baracos', 'Affiliation': 'Department of Oncology, Division of Palliative Care Medicine, University of Alberta, Edmonton, AB, T6G 1Z2, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. andrew.wilcock@nottingham.ac.uk.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3518-2']
950,32431023,Fatigue and activity after stroke. Secondary results from the Life After Stroke study.,"OBJECTIVES


The aim of this study was to describe how the prevalence of fatigue changed from the subacute phase to the chronic phase after stroke, and to investigate how activity was associated with fatigue among participants included in the randomized controlled multicentre-study Life After STroke (LAST).
METHODS


The present study represents secondary analysis based on data from the LAST study. One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included. Fatigue was assessed by the Fatigue Severity Scale (FSS-7) at inclusion, 3 months after stroke, and at follow-up 18 months later. activPAL was used to measure activity at follow-up.
RESULTS


A total of 46 (31.7%) participants reported fatigue at inclusion and 43 (29.7%) at follow-up (p = .736). In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
CONCLUSIONS


The present study showed that fatigue is a common symptom after stroke and that the prevalence of fatigue remained unchanged from the subacute to the chronic phase. The study also showed that increased time spent walking was strongly related to lower fatigue, while no such associations were found between the other activity categories and fatigue.",2020,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[""One-hundred-and-forty-five patients with mild and moderate stroke (mean (SD) age: 71.5 (10.5) years, 57.2% males) recruited from St. Olav's University Hospital were included""]",['activPAL'],"['Life', 'sedentary behaviour, walking and sedentary bouts', 'Fatigue and activity', 'fatigue', 'activity categories and fatigue', 'Fatigue', 'time spent walking', 'Fatigue Severity Scale (FSS-7']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}]",145.0,0.0425954,"In the univariable regression analysis, sedentary behaviour, walking and sedentary bouts were significantly associated with fatigue (p ≤ .015), whereas only time spent walking was significantly associated with fatigue in the multivariable regression analysis (p = .017).
","[{'ForeName': 'Ragnhild Sunde', 'Initials': 'RS', 'LastName': 'Braaten', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Torunn', 'Initials': 'T', 'LastName': 'Askim', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Gunnes', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1851']
951,32429867,Improving mental health literacy in year 9 high school children across Wales: a protocol for a randomised control treatment trial (RCT) of a mental health literacy programme across an entire country.,"BACKGROUND


Adolescence is a crucial period for developing and maintaining good habits for mental health and well-being. This is important for future mental health, as most mental health problems manifest during adolescence. Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents. The mental health literacy programme ""The Guide"", which was developed in Canada, has shown success in increasing mental health literacy in North American 16-17 year olds. ""The Guide Cymru"" is an adaptation of The Guide designed for a younger age group (13-14 year olds) and for the Welsh culture and context and is being offered to all state schools in Wales.
METHODS


This two-armed cluster randomised control trial (RCT) will evaluate the effectiveness of The Guide Cymru. All 205 secondary schools in Wales will be invited to take part, involving up to 30,000 year 9 pupils. Schools will be randomised to either the immediate implementation of The Guide Cymru or to a wait-list control. The wait-list control will receive The Guide Cymru around 12 weeks later. Measures of mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire) will be taken at baseline (pre-intervention), 12 weeks later (after the active group has received The Guide Cymru), and 24 weeks later (after the wait-list control has received The Guide Cymru).
DISCUSSION


The trial aims to evaluate if The Guide Cymru increases mental health literacy, including reduced stigma to others and to the self, and increased levels of good mental health behaviours and help-seeking for mental health problems.
TRIAL REGISTRATION


ISRCTN15462041. Registered 03/10/2019.",2020,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","['All 205 secondary schools in Wales will be invited to take part, involving up to 30,000\u2009year 9 pupils', 'year 9 high school children across Wales', 'mental health literacy in North American 16-17\u2009year olds']",['mental health literacy programme'],"['mental health literacy', 'mental health literacy (assessed via the Knowledge and Attitudes to Mental Health scale) and mental health problems (via the PedsQL and Strengths and Difficulties Questionnaire']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",,0.0827054,"Mental health literacy is the foundation for mental health prevention, stigma reduction, and increased help-seeking efficacy particularly among adolescents.","[{'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Simkiss', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Malone', 'Affiliation': 'Action for Children, Head Office: 3 The Boulevard, Ascot Road, Watford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kemp', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Snowden', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, Wales, CF10 3AT, UK. snowden@cardiff.ac.uk.'}]",BMC public health,['10.1186/s12889-020-08736-z']
952,31586194,Developing a Psychological-Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned From the Field.,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
PURPOSE


Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results-and resulting decision-making process-related to experiments at each step to display the practical challenges present at each stage.
METHODS


To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery.
RESULTS


Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process.
CONCLUSIONS


A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.",2020,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
",[],"['positive psychology (PP) based intervention', 'combined PP-motivational interviewing intervention', 'Multiphase Optimization Strategy']",[],[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],255.0,0.0166421,"BACKGROUND


The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center and Department of Human Development and Family Studies, Pennsylvania State University, University Park, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz035']
953,32128614,"Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial.","PURPOSE


Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS.
METHODS


A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a ""slight improvement.""
RESULTS


Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS.
CONCLUSION


TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least ""slight pain relief"" from PBT. Differences for gender and incident pain aspects demand future trials.",2020,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","['11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N\u2009=\u200920', '632 patients screened, 25', 'advanced cancer pain inpatients in specialist palliative care', 'adult inpatients with cancer pain ≥\u20093 on an 11-point numerical rating scale (NRS', 'inpatient specialist palliative care ward', 'Women and patients with incident pain']","['Transcutaneous electrical nerve stimulation (TENS', 'placebo TENS (PBT', 'Intensity-modulated high TENS (IMT', 'TENS', 'Transcutaneous electrical nerve stimulation']","['average pain intensity', 'uncomfortable feeling', 'slight improvement', 'analgesic effects', 'responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0222045'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",25.0,0.274577,"The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6).","[{'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Siemens', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany. waldemar.siemens@googlemail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Boehlke', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Bennett', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences (LIHS), School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Offner', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Clinic for Palliative Care, Medical Center, Faculty of Medicine, University of Freiburg, Robert-Koch-Str 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gaertner', 'Affiliation': 'Center for Palliative Care Hildegard, Basel, Switzerland.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05370-8']
954,31397263,The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study.,"BACKGROUND


Delirium is a common and serious neuropsychiatric syndrome, usually triggered by illness or drugs. It remains underdetected. One reason for this is a lack of brief, pragmatic assessment tools. The 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) is a screening tool designed for routine use. This project evaluated its usability, diagnostic accuracy and cost.
METHODS


Phase 1 - the usability of the 4AT in routine practice was measured with two surveys and two qualitative studies of health-care professionals, and a review of current clinical use of the 4AT as well as its presence in guidelines and reports. Phase 2 - the 4AT's diagnostic accuracy was assessed in newly admitted acute medical patients aged ≥ 70 years. Its performance was compared with that of the Confusion Assessment Method (CAM; a longer screening tool). The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes. The method used was a prospective, double-blind diagnostic test accuracy study in emergency departments or in acute general medical wards in three UK sites. Each patient underwent a reference standard delirium assessment and was also randomised to receive an assessment with either the 4AT ( n  = 421) or the CAM ( n  = 420). A health economics analysis was also conducted.
RESULTS


Phase 1 found evidence that delirium awareness is increasing, but also that there is a need for education on delirium in general and on the 4AT in particular. Most users reported that the 4AT was useful, and it was in widespread use both in the UK and beyond. No changes to the 4AT were considered necessary. Phase 2 involved 785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4) years, 45% were male, 99% were white and 9% had a known dementia diagnosis. The 4AT ( n  = 392) had an area under the receiver operating characteristic curve of 0.90. A positive 4AT score (> 3) had a specificity of 95% [95% confidence interval (CI) 92% to 97%] and a sensitivity of 76% (95% CI 61% to 87%) for reference standard delirium. The CAM ( n  = 382) had a specificity of 100% (95% CI 98% to 100%) and a sensitivity of 40% (95% CI 26% to 57%) in the subset of participants whom it was possible to assess using this. Patients with positive 4AT scores had longer lengths of stay (median 5 days, interquartile range 2.0-14.0 days) than did those with negative 4AT scores (median 2 days, interquartile range 1.0-6.0 days), and they had a higher 12-week mortality rate (16.1% and 9.2%, respectively). The estimated 12-week costs of an initial inpatient stay for patients with delirium were more than double the costs of an inpatient stay for patients without delirium (e.g. in Scotland, £7559, 95% CI £7362 to £7755, vs. £4215, 95% CI £4175 to £4254). The estimated cost of false-positive cases was £4653, of false-negative cases was £8956, and of a missed diagnosis was £2067.
LIMITATIONS


Patients were aged ≥ 70 years and were assessed soon after they were admitted, limiting generalisability. The treatment of patients in accordance with reference standard diagnosis limited the ability to assess comparative cost-effectiveness.
CONCLUSIONS


These findings support the use of the 4AT as a rapid delirium assessment instrument. The 4AT has acceptable diagnostic accuracy for acute older patients aged > 70 years.
FUTURE WORK


Further research should address the real-world implementation of delirium assessment. The 4AT should be tested in other populations.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN53388093.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 40. See the NIHR Journals Library website for further project information. The funder specified that any new delirium assessment tool should be compared against the CAM, but had no other role in the study design or conduct of the study.",2019,"The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes.","['785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4', 'acute medical patients', 'emergency departments or in acute general medical wards in three UK sites', 'years, 45% were male, 99% were white and 9% had a known dementia diagnosis', 'Patients were aged ≥\u200970 years and were assessed soon after they were admitted, limiting generalisability', 'acute older patients aged >\u200970 years', 'newly admitted acute medical patients aged ≥\u200970 years', 'patients with delirium']","['CAM', '4AT']","['longer lengths of stay', '12-week mortality rate', 'usability, diagnostic accuracy and cost', 'negative 4AT scores', 's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT', 'cognitive status, length of stay, new institutionalisation, mortality', 'positive 4AT score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",[],"[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0450977', 'cui_str': ""Hodkinson's test""}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",785.0,0.218407,"The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes.","[{'ForeName': 'Alasdair Mj', 'Initials': 'AM', 'LastName': 'MacLullich', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Shenkin', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Goodacre', 'Affiliation': 'Emergency Medicine, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Health and Social Care, Leeds Institute of Health Sciences, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hanley', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Antaine', 'Initials': 'A', 'LastName': 'Stíobhairt', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lavender', 'Affiliation': 'Health and Social Care, Leeds Institute of Health Sciences, School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Boyd', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'MacRaild', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Steven', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Black', 'Affiliation': 'Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Diernberger', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Zoë', 'Initials': 'Z', 'LastName': 'Tieges', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Geriatric Medicine, Division of Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Psychiatry, University of York, York.'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23400']
955,32128615,"Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy.","PURPOSE


We assessed the efficacy of aprepitant (APR) or 10 or 5 mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC).
METHODS


Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2-4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2-3 or OLN10 or OLN5 on days 1-4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120 h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life.
RESULTS


Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2-4 nausea were experienced by fewer patients for OLN10 than for APR (24-120 h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups.
CONCLUSIONS


Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.",2020,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","['Of 141 patients, 104 received AC and 37 received', 'patients receiving high-emetogenic chemotherapy (HEC', 'Patients who received', 'patients receiving high-emetogenic chemotherapy']","['ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone', 'placebo', 'cisplatin', 'olanzapine with ondansetron plus dexamethasone', 'aprepitant (APR) or 10 or 5\xa0mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone', 'APR125', 'OLN10 or OLN5', 'doxorubicin + cyclophosphamide or cisplatin']","['nausea and vomiting', 'median visual analog scale nausea score', 'CINV', 'degrees of vomiting, CR, and AE', 'CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life', 'Grades 2-4 nausea', 'no-nausea rates', 'nausea/vomiting (CINV) prophylaxis', 'nausea', 'CINV prevention efficacy']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",141.0,0.4139,"The median visual analog scale nausea score from 24 to 120 h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03).","[{'ForeName': 'Suthinee', 'Initials': 'S', 'LastName': 'Ithimakin', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand. aesi105@yahoo.co.th.'}, {'ForeName': 'Pathra', 'Initials': 'P', 'LastName': 'Theeratrakul', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Apirom', 'Initials': 'A', 'LastName': 'Laocharoenkiat', 'Affiliation': 'Pharmacy Department, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Akarin', 'Initials': 'A', 'LastName': 'Nimmannit', 'Affiliation': 'Department of Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Nopadol', 'Initials': 'N', 'LastName': 'Soparattanapaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Sirisopa', 'Initials': 'S', 'LastName': 'Techawattanawanna', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Krittiya', 'Initials': 'K', 'LastName': 'Korphaisarn', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}, {'ForeName': 'Pongwut', 'Initials': 'P', 'LastName': 'Danchaivijitr', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Chalermprakiat Building, 13th floor, Siriraj Hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok, Thailand.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05380-6']
956,31524828,Effects of Exercise on Plantar Pressure during Walking in Children with Overweight/Obesity.,"PURPOSE


To investigate the effect of a 13-wk exercise program, based on ""movement quality"" and ""multigames"" work, on plantar pressure during walking in children with overweight/obesity (OW/OB).
METHOD


Seventy children (10.8 ± 1.2 yr, 58.5% girls) with OW/OB, as defined by the World Obesity Federation, were assigned to either a 13-wk exercise program (intervention group [EG]; n = 39), or to a usual lifestyle control group (CG) (n = 31). Children underwent assessments of basic anthropometry (weight and height) and plantar pressure during walking before and after the intervention period, recording plantar surface area (cm), maximum force (N), and force-time integrals (N·s).
RESULTS


After the 13-wk intervention period, the EG participants showed no significant change in total plantar surface area, while the CG participants experienced an increase in this variable (small effect size, -2.5 SD; P = 0.015). Compared with the GC participants, the EG participants showed a greater increase in the maximum force supported beneath the forefoot during walking at the end of the intervention period (small effect size, 0.33 SD; P = 0.012), specifically under the lateral and medial forefoot (both P < 0.05). Force-time changed similarly in both groups by the end of the intervention period (all regions P > 0.05).
CONCLUSIONS


These results suggest the exercise program led to positive structural and functional changes in plantar pressure during walking. The increase in maximum force supported by the forefoot in the EG children might indicate a change toward a more normal foot rollover pattern and a more adult gait.",2020,"Force-time changed similarly in both groups by the end of the intervention period (all regions p>0.05).
","['Seventy children (10.8 ± 1.2 years, 58.5% girls) with OW/OB, as defined by the World Obesity Federation', 'Children with Overweight/Obesity', 'children with overweight/obesity (OW/OB']","['exercise program', 'Exercise', '13-week exercise program (intervention group [EG]; n=39), or to a usual lifestyle control group (CG', '13-week exercise program']","['Force-time', 'Plantar Pressure', 'total plantar surface area', 'basic anthropometry (weight and height) and plantar pressure', 'plantar pressure']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",70.0,0.0203797,"Force-time changed similarly in both groups by the end of the intervention period (all regions p>0.05).
","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Molina-Garcia', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Miranda-Aparicio', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Molina-Molina', 'Affiliation': 'Research Group CTS-545 ERGOLAB ""Sport Physical Activity and Ergonomy to Life Quality,"" Department of Physical and Sports Education, Faculty of Sports Science, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Plaza-Florido', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jairo H', 'Initials': 'JH', 'LastName': 'Migueles', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cadenas-Sanchez', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Esteban-Cornejo', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rodriguez-Ayllon', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Solis-Urra', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Vanrenterghem', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven-University of Leuven, BELGIUM.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, SPAIN.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002157']
957,32430774,Effect of treatment with a full-occlusion biofeedback splint on sleep bruxism and TMD pain: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of the present study was to analyze treatment outcome with a full-occlusion biofeedback (BFB) splint on sleep bruxism (SB) and TMD pain compared with treatment with an adjusted occlusal splint (AOS).
MATERIALS AND METHODS


Forty-one patients were randomly allocated to a test (BFB) or a control (AOS) group and monitored over a 3-month period. Output variables were frequency and duration of bruxing events (bursts) and various pain symptoms.
RESULTS


The BFB group showed a statistically significant reduction in the frequency and duration of bursts and a statistically significant improvement in the patients' global well-being and the facial muscle pain parameter. After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
CONCLUSIONS


The tested BFB splint is highly effective in reducing SB at the subconscious level, i.e., without waking the patient, and in achieving improvements in global pain perception. The results suggest that the BFB splint also provides a better treatment option for bruxism-related pain than an AOS. However, further research is needed, and specifically studies with a larger patient population displaying higher levels of pain at baseline.
CLINICAL RELEVANCE


By reducing burst duration and therefore the pathological load on the masticatory apparatus, the BFB splint reduces TMD and bruxism-related symptoms and improves patients' physical well-being. In the long term, this could prevent damage to the TMJ. This study confirms the effectiveness and safety of this splint.
THE UNIVERSAL TRIAL NUMBER


U1111-1239-2450 DRKS-ID REGISTRATION: DRKS00018092.",2020,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
",['Forty-one patients'],"['BFB splint', 'adjusted occlusal splint (AOS', 'test (BFB) or a control (AOS', 'full-occlusion biofeedback splint', 'full-occlusion biofeedback (BFB) splint']","['sleep bruxism (SB) and TMD pain', 'average and maximum duration', 'frequency and duration of bruxing events (bursts) and various pain symptoms', 'sleep bruxism and TMD pain', 'frequency of bursts', ""patients' global well-being and the facial muscle pain parameter"", 'frequency and duration of bursts', 'global pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015460', 'cui_str': 'Facial Muscles'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",41.0,0.0790369,"After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany. Alexander.Bergmann@med.uni-muenchen.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edelhoff', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schubert', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Kurt-Jürgen', 'Initials': 'KJ', 'LastName': 'Erdelt', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Pho Duc', 'Affiliation': 'Department of Prosthetic Dentistry, University Hospital, LMU Munich, Goethestraße 70, 80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03270-z']
958,32114513,Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study.,"INTRODUCTION


To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.
METHODS


Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.
RESULTS


Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.
DISCUSSION


Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.",2020,Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity.,"['advanced cervical cancer', '227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity', 'women receiving chemotherapy with bevacizumab in GOG240', 'advanced/recurrent cervical cancer patients receiving']","['chemotherapy with bevacizumab', 'bevacizumab']","['toxicities included hematologic, gastrointestinal, and pain', 'neurotoxicity and pain', 'quality of life assessment', 'toxicities', 'toxicity', 'quality of life', 'median survival time', 'FACT-Cx TOI scores']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",227.0,0.0254237,Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Chase', 'Affiliation': 'Arizona Oncology, Paradise Valley, California, USA dana.chase@usoncology.com.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, New York, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Ob Gyn/Gyn Onc, Creighton University School of Medicine at St Josephs Hospital and Medical Center, Phoenix, Arizona, USA.'}, {'ForeName': 'Lois Michelle', 'Initials': 'LM', 'LastName': 'Ramondetta', 'Affiliation': 'Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gil', 'Affiliation': 'Psychology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Landrum', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leitao', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d' Hebron Institute of Oncology, University Hospital, Barcelona, Spain.""}, {'ForeName': 'Warner K', 'Initials': 'WK', 'LastName': 'Huh', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Pulaski', 'Affiliation': 'Gynecological Oncology, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'Robison', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.'}, {'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Gynecologic Oncology, University of Colorado Cancer Center, Aurora, Colorado, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'UT Southwestern Medical, Dallas, Texas, USA.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'Ob/Gyn, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, New York, USA.'}, {'ForeName': 'Lari B', 'Initials': 'LB', 'LastName': 'Wenzel', 'Affiliation': 'University of California Irvine School of Medicine, Irvine, California, USA.'}, {'ForeName': 'Krishnansu Sujata', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California Irvine School of Medicine, Orange, California, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000869']
959,32428202,The work of older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting.,"BACKGROUND


There is limited understanding of the contribution made by older people and their caregivers to acute healthcare in the home and how this compares to hospital inpatient healthcare.
OBJECTIVES


To explore the work of older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH) and how their experiences relate to the principles underpinning comprehensive geriatric assessment (CGA).
DESIGN


A qualitative interview study within a UK multi-site participant randomised trial of geriatrician-led admission avoidance HAH, compared with hospital inpatient care.
METHODS


We conducted semi-structured interviews with 34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018. We used normalisation process theory to guide our analysis and interpretation of the data.
RESULTS


Patients and caregivers described efforts to understand changes in health, interpret assessments and mitigate a lack of involvement in decisions. Practical work included managing risks, mobilising resources to meet health-related needs, and integrating the acute episode into longer-term strategies. Personal, relational and environmental factors facilitated or challenged adaptive capacity and ability to manage.
CONCLUSIONS


Patients and caregivers contributed to acute healthcare in both locations, often in parallel to healthcare providers. Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.",2020,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","['34 older people (15 had received HAH and 19 hospital care) alone or alongside caregivers (29 caregivers; 12 HAH, 17 hospital care), in three sites that recruited participants to a randomised trial, during 2017-2018', 'older people and their informal caregivers in managing an acute health event in a hospital at home or hospital inpatient setting', 'older people and caregivers at the time of an acute health event, the interface with professionals in a hospital and hospital at home (HAH']",['geriatrician-led admission avoidance HAH'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],,0.105641,"Our findings highlight an opportunity for CGA-guided services at the interface of acute and chronic condition management to facilitate personal, social and service strategies extending beyond an acute episode of healthcare.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Mäkelä', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ellis', 'Affiliation': 'Monklands Hospital, NHS Lanarkshire, Glasgow, UK.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Schiff', 'Affiliation': ""Department of Ageing and Health, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Shepperd', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]",Age and ageing,['10.1093/ageing/afaa085']
960,31726876,Estimation of Controlled Direct Effects in Longitudinal Mediation Analyses with Latent Variables in Randomized Studies.,"In a randomized study with longitudinal data on a mediator and outcome, estimating the direct effect of treatment on the outcome at a particular time requires adjusting for confounding of the association between the outcome and all preceding instances of the mediator. When the confounders are themselves affected by treatment, standard regression adjustment is prone to severe bias. In contrast, G-estimation requires less stringent assumptions than path analysis using SEM to unbiasedly estimate the direct effect even in linear settings. In this article, we propose a G-estimation method to estimate the controlled direct effect of treatment on the outcome, by adapting existing G-estimation methods for time-varying treatments without mediators. The proposed method can accommodate continuous and noncontinuous mediators, and requires no models for the confounders. Unbiased estimation only requires correctly specifying a mean model for either the mediator or the outcome. The method is further extended to settings where the mediator or outcome, or both, are latent, and generalizes existing methods for single measurement occasions of the mediator and outcome to longitudinal data on the mediator and outcome. The methods are utilized to assess the effects of an intervention on physical activity that is possibly mediated by motivation to exercise in a randomized study.",2020,"In contrast, G-estimation requires less stringent assumptions than path analysis using SEM to unbiasedly estimate the direct effect even in linear settings.",[],[],[],[],[],[],,0.0325293,"In contrast, G-estimation requires less stringent assumptions than path analysis using SEM to unbiasedly estimate the direct effect even in linear settings.","[{'ForeName': 'Wen Wei', 'Initials': 'WW', 'LastName': 'Loh', 'Affiliation': 'Department of Data Analysis, Ghent University, Gent, Belgium.'}, {'ForeName': 'Beatrijs', 'Initials': 'B', 'LastName': 'Moerkerke', 'Affiliation': 'Department of Data Analysis, Ghent University, Gent, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Loeys', 'Affiliation': 'Department of Data Analysis, Ghent University, Gent, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Poppe', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Gent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Gent, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Vansteelandt', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Gent, Belgium.'}]",Multivariate behavioral research,['10.1080/00273171.2019.1681251']
961,31419483,Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial.,"OBJECTIVES


The aim was to evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 g, the recommended European first-line gonorrhoea treatment.
METHODS


A non-inferiority, open-label, single-centre randomized controlled trial was conducted in Prague, Czech Republic. Patients, 18-75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomized to treatment with gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin 2 g orally. The primary outcome was negative culture and negative NAAT, i.e. 1 week and 3 weeks, respectively, after treatment.
RESULTS


Both clinical cure and microbiological clearance was achieved by 100% (95% CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n = 72; 40 rectal, 17 pharyngeal and 15 rectal+pharyngeal infections both localizations) and 100% (95% CI 0.95-1.00) in ceftriaxone/azithromycin arm (n = 71; 38 rectal, 14 pharyngeal and 19 rectal+pharyngeal infections). The absolute difference between the two arms was 0.0% (CI95% -5.1 to 5.1), thus less than the pre-specified margin of 7%. Administration of gentamicin was not more painful than ceftriaxone according to the visual analogue scale (1.8 vs. 3.4; p <0.001). Gastrointestinal adverse events were similar in the ceftriaxone arm (33/71, 46.5%) and the gentamicin arm (29/72, 40.3%), and overall in most (52/62, 83.9%) cases they were mild.
CONCLUSIONS


Gentamicin 240 mg plus azithromycin 2 g is an effective alternative for treatment of extragenital gonorrhoea.",2020,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","['rectal and pharyngeal gonorrhoea', 'A non-inferiority, open-label, single centre randomized controlled trial was conducted in Prague, Czech Republic', 'Patients, 18-75\xa0years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT']","['ceftriaxone/azithromycin', 'gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin', 'ceftriaxone 500 mg plus azithromycin', 'Gentamicin 240 mg plus azithromycin', 'gentamicin 240 mg plus azithromycin', 'gentamicin', 'gentamicin/azithromycin', 'ceftriaxone']","['negative culture and negative NAAT', 'clinical cure and microbiological clearance', 'visual analog scale', 'efficacy and tolerability', 'Gastrointestinal adverse events']","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.117736,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rob', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. Electronic address: filip.rob@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klubalová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nyčová', 'Affiliation': 'Department of Microbiology, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hercogová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.08.004']
962,31713060,Massage therapy reduces arterial puncture-induced pain: the randomized cross-over bi-center TORREA study.,,2020,,[],['Massage therapy'],['arterial puncture-induced pain'],[],"[{'cui': 'C3536731', 'cui_str': 'Massage Therapy'}]","[{'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0252838,,"[{'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France. sigismond@lasocki.com.""}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Moncho', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bontemps', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Verger', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Anne-Charlotte', 'Initials': 'AC', 'LastName': 'Tellier', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandière', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-019-05838-0']
963,18870272,Blind eye in children.,,1948,,[],[],[],[],[],[],,0.0624617,,"[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'DEKKING', 'Affiliation': ''}]",Nederlands tijdschrift voor geneeskunde,[]
964,31654434,In response to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['propofol', 'Dexmedetomidine']",[],[],"[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0283193,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tonsy', 'Initials': 'T', 'LastName': 'Pandiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Otolaryngology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.28363']
965,31567305,The Effect of Auricular Acupressure and Positive Group Psychotherapy With Motivational Interviewing for Smoking Cessation in Korean Adults.,"The aim of this study was to investigate the effects of positive group psychotherapy with auricular acupressure on tobacco withdrawal symptoms and smoking cessation. This study used a randomized controlled trial design. Participants were randomly assigned to 1 of 3 groups: group 1 (counseling and auricular acupressure), group 2 (counseling and placebo acupressure), and the control group (self-help for smoking cessation). Positive group psychotherapy and auricular acupressure were performed once a week for 6 weeks. The smoking cessation rates for 1 year in groups 1 and 2 were higher than that in the control group (9.5%, 15.6%, and 0%, respectively; odd ratio: 7.98, P = .019, n = 109). There was a significant difference of tobacco withdrawal symptoms among the 3 groups over 4 weeks (F = 2.9, P = .04). The mean differences between week 1 and week 4 among the 3 groups were statistically significant (4.7 ± 6.96, 5.18 ± 7.9, and 0.14 ± 7.15, F = 4.25, P = .018).",2020,"There was a significant difference of tobacco withdrawal symptoms among the 3 groups over 4 weeks (F = 2.9, P = .04).",['Korean Adults'],"['positive group psychotherapy with auricular acupressure', 'group 1 (counseling and auricular acupressure), group 2 (counseling and placebo acupressure), and the control group (self-help for smoking cessation', 'Motivational Interviewing', 'Positive group psychotherapy and auricular acupressure', 'Auricular Acupressure and Positive Group Psychotherapy']","['tobacco withdrawal symptoms and smoking cessation', 'tobacco withdrawal symptoms', 'smoking cessation rates']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C1167842', 'cui_str': 'Tobacco withdrawal symptoms'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0572295,"There was a significant difference of tobacco withdrawal symptoms among the 3 groups over 4 weeks (F = 2.9, P = .04).","[{'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Inha University, Incheon, Republic of Korea.'}]",Holistic nursing practice,['10.1097/HNP.0000000000000348']
966,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
967,31515141,"A phase 1 study of the safety, reactogenicity, and immunogenicity of a Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF) in healthy adults from a non-endemic area.","BACKGROUND


Schistosomiasis caused by Schistosoma mansoni (Sm) is a chronic, debilitating and potentially deadly neglected tropical disease. The licensure of a vaccine to prevent schistosomiasis would represent a major breakthrough in public health.
METHODS


The safety and immunogenicity of a candidate Sm vaccine were assessed in this phase I, double-blind, dose-escalation trial. Seventy-two healthy Sm-naïve 18-50 year olds were randomized to receive 3 doses ∼ 8 weeks apart of saline placebo, or 10 µg, 30 µg, or 100 µg of recombinant Sm-Tetraspanin-2 vaccine formulated on aluminum hydroxide adjuvant (Sm-TSP-2/Al) with or without 5 µg of glucopyranosyl lipid A aqueous formulation (GLA-AF). Clinical and serologic responses were assessed for 1 year after dose 3.
RESULTS


Vaccines were safe and well-tolerated. The most common reactions were injection site tenderness and pain, and headache and fatigue. Tenderness and pain were more frequent in groups receiving vaccine with GLA-AF than placebo (p = 0.0036 and p = 0.0014, respectively). Injection site reactions among those given Sm-TSP-2/Al with GLA-AF lasted 1.22 and 1.33 days longer than those receiving Sm-TSP-2/Al without GLA-AF or placebo (p < 0.001 for both). Dose- and adjuvant-related increases in serum IgG against Sm-TSP-2 were observed. Peak IgG levels occurred 14 days after dose 3. Seroresponse frequencies were low among recipients of Sm-TSP-2/Al without GLA-AF, but higher among subjects receiving 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF. More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively). Seroresponse frequencies were 0%, 30%, 50%, and 89%, respectively, among those given placebo, or 10 µg, 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF, suggesting a dose-response relationship for Sm-TSP-2/Al with GLA-AF (p = 0.0001).
CONCLUSIONS


Sm-TSP-2/Al with or without GLA-AF was safe and well tolerated in a Sm-naïve population. A vaccine like the one under development may represent our best hope to eliminating this neglected tropical disease.",2019,"More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively).","['healthy adults from a non-endemic area', 'Seventy-two healthy Sm-naïve 18-50\u202fyear olds']","['Sm-TSP-2/Al with or without GLA', 'saline placebo', 'Schistosoma mansoni vaccine with or without glucopyranosyl lipid A aqueous formulation (GLA-AF', 'placebo', 'recombinant Sm-Tetraspanin-2 vaccine formulated on aluminum hydroxide adjuvant (Sm-TSP-2/Al) with or without 5\u202fµg of glucopyranosyl lipid A aqueous formulation (GLA-AF']","['safe and well-tolerated', 'serum IgG against Sm-TSP-2', 'Clinical and serologic responses', 'Tenderness and pain', 'Seroresponse frequencies', 'Injection site reactions', 'injection site tenderness and pain, and headache and fatigue', 'safe and well tolerated', 'safety and immunogenicity', 'Peak IgG levels', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4276833', 'cui_str': 'glucopyranosyl lipid-A'}, {'cui': 'C3178812', 'cui_str': 'Tetraspanins'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0863083', 'cui_str': 'Injection site tenderness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",72.0,0.0857473,"More seroresponses were observed among those given 30 µg or 100 µg of Sm-TSP-2/Al with GLA-AF compared to placebo (p = 0.023 and p < 0.001, respectively).","[{'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Keitel', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: wkeitel@bcm.edu.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'The Emmes Corporation, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Diemert', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bethony', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Corporation, United States.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Plieskatt', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington, DC, United States.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jones', 'Affiliation': 'Division of Microbiology and Infectious Diseases (DMID), National Institutes of Allergy and Infectious. Diseases (NIAID), National Institutes of Health (NIH), United States.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deye', 'Affiliation': 'Division of Microbiology and Infectious Diseases (DMID), National Institutes of Allergy and Infectious. Diseases (NIAID), National Institutes of Health (NIH), United States.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Bottazzi', 'Affiliation': ""Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States; Texas Children's Hospital Center for Vaccine Development, Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.""}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Hotez', 'Affiliation': ""Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States; Texas Children's Hospital Center for Vaccine Development, Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States.""}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.08.075']
968,31375279,Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension.,"BACKGROUND


It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy.
OBJECTIVE


To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy.
DESIGN, SETTING, AND PARTICIPANTS


This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion.
INTERVENTION


A total of 126 patients received adjuvant radiotherapy at 66.6Gy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints.
RESULTS AND LIMITATIONS


The median follow-up time for patients who were alive when the follow-up ended was 9.3yr in the adjuvant group and 8.6yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p<0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p=0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p=0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients.
CONCLUSIONS


Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
PATIENT SUMMARY


Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone.",2019,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","['250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion', '43 patients with biochemical recurrence in the observation group, 37 patients received', 'patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy', 'Prostate Cancer Patients with Positive Margins or Extracapsular Extension', '126 patients received', 'patients with positive margins or extracapsular extension']","['Radical Prostatectomy Versus Radical Prostatectomy Alone', 'Adjuvant radiotherapy', 'radical prostatectomy alone', 'adjuvant radiotherapy', 'Radiotherapy', 'Adjuvant Radiotherapy', 'salvage radiotherapy']","['Overall survival, cancer-specific survival, local recurrence, and adverse events', 'overall survival', '10-yr survival for biochemical recurrence', 'effectiveness and tolerability', 'grade 3 adverse events', 'tolerated and prolongs biochemical recurrence-free survival', 'biochemical recurrence-free survival', 'median follow-up time']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0036628', 'cui_str': 'Seminal Vesicles'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",250.0,0.344689,"Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension.
","[{'ForeName': 'Greetta', 'Initials': 'G', 'LastName': 'Hackman', 'Affiliation': 'Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Kouri', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Joensuu', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Luukkaala', 'Affiliation': 'Research, Development and Innovation Center, Tampere University Hospital and Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Salonen', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Isotalo', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Pétas', 'Affiliation': 'Department of Urology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Niilo', 'Initials': 'N', 'LastName': 'Hendolin', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Boström', 'Affiliation': 'Department of Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Aaltomaa', 'Affiliation': 'Department of Urology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lehtoranta', 'Affiliation': 'Department of Urology, Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Hellström', 'Affiliation': 'Department of Urology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Department of Surgery, Tampere University Hospital, Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Korpela', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Minn', 'Affiliation': 'Department of Oncology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Finnish Cancer Registry-Institute for Statistical and Epidemiological Cancer Research, Helsinki, Finland; Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Akseli', 'Initials': 'A', 'LastName': 'Hemminki', 'Affiliation': 'Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Docrates Cancer Center, Helsinki, Finland; Cancer Gene Therapy Group, Translational Immunology Research Program, University of Helsinki, Helsinki, Finland. Electronic address: akseli.hemminki@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.07.001']
969,1527133,The A-V Impulse System reduces deep-vein thrombosis and swelling after hemiarthroplasty for hip fracture.,"We performed a prospective randomised controlled trial of the A-V Impulse System in 82 patients treated by hemiarthroplasty for subcapital fracture of the femoral neck. The incidence of proximal deep-vein thrombosis as assessed by Doppler ultrasonography was 23% in the control group and 0% in those using the device (p less than 0.01). Calf and thigh circumferences were measured in both groups at seven to ten days after operation. In the treatment group there was a mean relative reduction of postoperative swelling of the thigh by 3.27 cm (p less than 0.001) and of the calf by 1.55 cm (p less than 0.001). The A-V Impulse System appears to be a safe and effective method of reducing the incidence of proximal deep-vein thrombosis, and of postoperative swelling.",1992,"The A-V Impulse System appears to be a safe and effective method of reducing the incidence of proximal deep-vein thrombosis, and of postoperative swelling.","['82 patients treated by hemiarthroplasty for subcapital fracture of the femoral neck', 'after hemiarthroplasty for hip fracture']",[],"['incidence of proximal deep-vein thrombosis', 'Calf and thigh circumferences', 'Doppler ultrasonography', 'deep-vein thrombosis and swelling', 'postoperative swelling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",82.0,0.0349379,"The A-V Impulse System appears to be a safe and effective method of reducing the incidence of proximal deep-vein thrombosis, and of postoperative swelling.","[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Stranks', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth, Hampshire, England.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'MacKenzie', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Grover', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fail', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
970,31620778,Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy.,"OBJECTIVES


The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease.
METHODS


The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years.
RESULTS


SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG.
CONCLUSIONS


In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality.",2020,"SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001].",['patients with left main coronary artery disease treated by'],"['PCI versus CABG', 'percutaneous coronary intervention', 'PCI', 'CABG', 'SYNTAX score II recommendation for surgery', 'coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI']",['higher mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0656431,"SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001].","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Medtronic, Maastricht, Netherlands.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, London, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz274']
971,32103441,Instability in End-of-Life Care Preference Among Heart Failure Patients: Secondary Analysis of a Randomized Controlled Trial in Singapore.,"BACKGROUND


Efforts to improve quality of end-of-life (EOL) care are increasingly focused on eliciting patients' EOL preference through advance care planning (ACP). However, if patients' EOL preference changes over time and their ACP documents are not updated, these documents may no longer be valid at the time EOL decisions are made.
OBJECTIVES


To assess extent and correlates of changes in stated preference for aggressive EOL care over time.
DESIGN


Secondary analysis of data from a randomized controlled trial of a formal ACP program versus usual care in Singapore.
PATIENTS


Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4 months for up to 2 years to assess their preference for EOL care. Analytic sample included 200 patients interviewed at least twice.
RESULTS


Nearly two thirds (64%) of patients changed their preferred type of EOL care at least once. Proportion of patients changing their stated preference for type of EOL care increased with time and the change was not unidirectional. Patients who understood their prognosis correctly were less likely to change their preference from non-aggressive to aggressive EOL care (OR 0.66, p value 0.07) or to prefer aggressive EOL care (OR 0.53; p value 0.001). On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
CONCLUSION


The study provides evidence of instability in HF patients' stated EOL care preference. This undermines the value of an ACP document recorded months before EOL decisions are made unless a strategy exists for easily updating this preference.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02299180.",2020,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","['Two hundred eighty-two patients with heart failure (HF) and New York Heart Association Classification III and IV symptoms were recruited and interviewed every 4\xa0months for up to 2\xa0years to assess their preference for EOL care', 'Heart Failure Patients', '200 patients interviewed at least twice']",['formal ACP program versus usual care in Singapore'],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]",[],282.0,0.0539074,"On the other hand, patient-surrogate discussion of care preference was associated with a higher likelihood of change in patient preference from aggressive to non-aggressive EOL care (OR 1.83; p value 0.03).
","[{'ForeName': 'Chetna', 'Initials': 'C', 'LastName': 'Malhotra', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. chetna.malhotra@duke-nus.edu.sg.'}, {'ForeName': 'Meibo', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre Singapore, 5 Hospital Drive, Singapore, 169609, Singapore.'}, {'ForeName': 'Fazlur Rehman', 'Initials': 'FR', 'LastName': 'Jaufeerally', 'Affiliation': 'Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Filipinas G', 'Initials': 'FG', 'LastName': 'Bundoc', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-020-05740-2']
972,31509451,Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.,"Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.",2020,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","['military veterans', 'Veterans with Chronic Low-Back Pain', '150 military veterans (Veterans Administration patients) with cLBP']","['cLBP', 'yoga or a delayed-treatment group receiving usual care', 'physical postures, movement, focused attention, and breathing techniques']","['Chronic low-back pain (cLBP', 'pain interference, fatigue, quality of life, and self-efficacy', 'Roland-Morris Disability Questionnaire scores', 'number of important secondary health outcomes', 'pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0589098', 'cui_str': 'Focused attention, function (observable entity)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",150.0,0.075649,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmalzl', 'Affiliation': 'College of Science and Integrative Health, Southern California University of Health Sciences, Whittier; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Chang', 'Affiliation': 'VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Adhana', 'Initials': 'A', 'LastName': 'McCarthy', 'Affiliation': 'SDSU/UC San Diego Joint Doctoral Program in Public Health, La Jolla, Calif.; and Army Medical Department Center and Schools, San Antonio.'}, {'ForeName': 'Won I', 'Initials': 'WI', 'LastName': 'Chun', 'Affiliation': 'VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sinclair', 'Affiliation': 'VA San Diego Healthcare System.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Bormann', 'Affiliation': 'Hahn School of Nursing & Health Sciences, University of San Diego; and VA Center of Excellence in Stress and Mental Health, San Diego.'}]",International journal of yoga therapy,['10.17761/2020-D-19-00036']
973,31519550,Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial.,"BACKGROUND AND OBJECTIVES


The short-term effects of low-phosphate diets on fibroblast growth factor 23 (FGF23) level and the optimal amount of dietary phosphate restriction in patients undergoing hemodialysis remain unknown.
DESIGN SETTING, PARTICIPANTS, & MEASUREMENTS


This was a randomized, active-controlled trial with a crossover design that included 35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan. Subjects were randomized 1:1 to receive a very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio of 10 mg/g for 2 days, each with a 5-day washout during which subjects adhered to their usual diet. The primary outcome measure was mean difference in change-from-baseline intact FGF23 level between intervention groups. Secondary outcomes included difference in change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level between intervention groups.
RESULTS


There was no significant difference in the mean change-from-baseline in intact FGF23 levels between the two study diets. The very-low-phosphate diet significantly lowered serum phosphate (mean difference, 0.6 mg/dl; 95% confidence interval [95% CI], 0.2 to 1.0;  P =0.002). There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
CONCLUSIONS


Over the 2-day period, the FGF23-lowering effect of the very-low-phosphate diet is similar to that of the low-phosphate diet. The very-low-phosphate diet has an additional phosphate-lowering effect compared with the low-phosphate diet.",2019,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","['Hemodialysis Patients', '35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan', 'patients undergoing hemodialysis remain unknown']","['Very-Low-Phosphate and Low-Phosphate Diets', 'low-phosphate diets', 'very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio']","['mean difference in change-from-baseline intact FGF23 level', 'intact FGF23 levels', 'serum phosphate', 'change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level', 'Fibroblast Growth Factor 23', 'change-from-baseline intact PTH and C-terminal FGF23 levels', 'fibroblast growth factor 23 (FGF23) level']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0452351', 'cui_str': 'Low phosphate diet (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",35.0,0.035397,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","[{'ForeName': 'Wan-Chuan', 'Initials': 'WC', 'LastName': 'Tsai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, klchien@ntu.edu.tw mia23448@gmail.com.'}, {'ForeName': 'Hon-Yen', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yu-Sen', 'Initials': 'YS', 'LastName': 'Peng', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Shih-Ping', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yen-Ling', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Ju-Yeh', 'Initials': 'JY', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Hung-Yuan', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Mei-Fen', 'Initials': 'MF', 'LastName': 'Pai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Wan-Yu', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Kuan-Yu', 'Initials': 'KY', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Fang-Yeh', 'Initials': 'FY', 'LastName': 'Chu', 'Affiliation': 'Department of Clinical Pathology, and.'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Tsai', 'Affiliation': 'Dietary Department, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Kuo-Liong', 'Initials': 'KL', 'LastName': 'Chien', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan; klchien@ntu.edu.tw mia23448@gmail.com.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.04250419']
974,31268828,Myofibrillar protein synthesis and muscle hypertrophy individualized responses to systematically changing resistance training variables in trained young men.,"The manipulation of resistance training (RT) variables is used among athletes, recreational exercisers, and compromised populations (e.g., elderly) attempting to potentiate muscle hypertrophy. However, it is unknown whether an individual's inherent predisposition dictates the RT-induced muscle hypertrophic response. Resistance-trained young [26 (3) y] men ( n  = 20) performed 8 wk unilateral RT (2 times/wk), with 1 leg randomly assigned to a standard progressive RT [control (CON)] and the contralateral leg to a variable RT (VAR; modulating exercise load, volume, contraction type, and interset rest interval). The VAR leg completed all 4 RT variations every 2 wk. Bilateral vastus lateralis cross-sectional area (CSA) was measured, pre- and post-RT and acute integrated myofibrillar protein synthesis (MyoPS) rates were assessed at rest and over 48 h following the final RT session. Muscle CSA increase was similar between CON and VAR ( P  > 0.05), despite higher total training volume (TTV) in VAR ( P  < 0.05). The 0-48-h integrated MyoPS increase postexercise was slightly greater for VAR than CON ( P  < 0.05). All participants were considered ""responders"" to RT, although none benefited to a greater extent from a specific protocol. Between-subjects variability (MyoPS, 3.30%; CSA, 37.8%) was 40-fold greater than the intrasubject (between legs) variability (MyoPS, 0.08%; CSA, 0.9%). The higher TTV and greater MyoPS response in VAR did not translate to a greater muscle hypertrophic response. Manipulating common RT variables elicited similar muscle hypertrophy than a standard progressive RT program in trained young men. Intrinsic individual factors are key determinants of the MyoPS and change in muscle CSA compared with extrinsic manipulation of common RT variables. NEW & NOTEWORTHY  Systematically manipulating resistance training (RT) variables during RT augments the stimulation of myofibrillar protein synthesis (MyoPS) and training volume but fails to potentiate muscle hypertrophy compared with a standard progressive RT. Any modest further MyoPS increase and higher training volumes do not reflect in a greater hypertrophic response. Between-subject variability was 40-fold greater than the variability promoted by extrinsic manipulation of RT variables, indicating that individual intrinsic factors are stronger determinants of the hypertrophic response.",2019,"Muscle CSA increase was similar between CON and VAR (P>0.05), despite higher total training volume (TTV) in VAR (P<0.05).","['athletes, recreational exercisers and compromised populations (e.g., elderly', 'trained young men', 'Twenty resistance-trained young (26(3)y) men performed 8wk unilateral RT (2∙wk -1 ) with one leg randomly assigned to a']","['standard progressive-RT program', 'standard progressive RT (CON), and the contralateral leg to a variable RT (VAR, modulating exercise load, volume, contraction type and interset rest interval']","['Bilateral  vastus lateralis  cross-sectional area (CSA', 'MyoPS response', 'Muscle CSA increase', 'myofibrillar protein synthesis (MyoPS) rates', 'total training volume (TTV', 'muscle hypertrophic response']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",,0.016115,"Muscle CSA increase was similar between CON and VAR (P>0.05), despite higher total training volume (TTV) in VAR (P<0.05).","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Damas', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Angleri', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Oliver C', 'Initials': 'OC', 'LastName': 'Witard', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Santanielo', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Soligon', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Luiz A R', 'Initials': 'LAR', 'LastName': 'Costa', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel E', 'Initials': 'ME', 'LastName': 'Lixandrão', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Miguel S', 'Initials': 'MS', 'LastName': 'Conceição', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB-Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00350.2019']
975,31318613,Local exercise does not prevent the aortic stiffening response to acute prolonged sitting: a randomized crossover trial.,"Prolonged sitting has been shown to promote endothelial dysfunction in the lower legs. Furthermore, it has been reported that simple sitting-interruption strategies, including calf raises, prevent leg endothelial dysfunction. However, it is unclear whether prolonged sitting affects central cardiovascular health, or whether simple sitting-interruption strategies prevent impaired central cardiovascular health. This study sought to answer two questions: in young, healthy adults  1 ) does prolonged sitting (3 h) lead to increased aortic stiffness, and  2 ) do intermittent calf raise exercises to prevent pooling prevent aortic stiffening. Twenty young, healthy participants (21.7 ± 2.5 yr, 70% female, 25.5 ± 6.1 kg/m 2 ) were randomized to 3 h of sitting with (CALF) or without (CON) 10 calf raises every 10 min. Aortic stiffening [carotid-femoral pulse wave velocity (PWV)] was measured in the supine position pre- and post-sitting. Venous pooling during sitting was estimated with total hemoglobin (tHB) concentration using near-infrared spectroscopy. There were no condition × time interactions. Following 3 h of sitting, PWV significantly increased (0.30 ± 0.46 m/s,  P  < 0.001). There was no condition effect for PWV ( P  = 0.694), indicating the intermittent calf rises did not preserve central cardiovascular health. tHb was not significantly affected by sitting ( P  = 0.446) but was 1.9 μM higher for CON versus CALF ( P  = 0.106). Sitting increases aortic stiffness in young, healthy individuals, a process that may be influenced by lower extremity blood pooling. Calf raises, which have been reported to preserve vascular function in the legs, do not appear to provide sufficient stimulus for maintaining central cardiovascular health. NEW & NOTEWORTHY  Although simple strategies, such as fidgeting or calf raises, are sufficient for preserving vascular function in the legs, data from the current study indicate that such strategies are not sufficient for maintaining central cardiovascular health, which is linked to cardiovascular disease.",2019,"tHb was not significantly affected by sitting (p=0.446) but was 1.9 μM higher for CON vs. CALF (p=0.106).
","['young, healthy individuals', 'young, healthy adults (i', 'Twenty young, healthy participants (21.7±2.5 y, 70% F, 25.5±6.1 kg/m 2 ']","['CON vs. CALF', 'Sitting', 'sitting with (CALF) or without (CON) 10 calf raises every 10 min']","['central cardiovascular health', 'Aortic stiffening (carotid-femoral pulse wave velocity, PWV', 'total hemoglobin (tHB) concentration', 'condition x time interactions', 'aortic stiffness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}]",20.0,0.0489022,"tHb was not significantly affected by sitting (p=0.446) but was 1.9 μM higher for CON vs. CALF (p=0.106).
","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kelsch', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, Mississippi.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00318.2019']
976,31246555,Effects of dynamic arm and leg exercise on muscle sympathetic nerve activity and vascular conductance in the inactive leg.,"The influence of muscle sympathetic nerve activity (MSNA) responses on local vascular conductance during exercise are not well established. Variations in exercise mode and active muscle mass can produce divergent MSNA responses. Therefore, we sought to examine the effects of small- versus large-muscle mass dynamic exercise on vascular conductance and MSNA responses in the inactive limb. Thirty-five participants completed two study visits in a randomized order. During  visit 1 , superficial femoral artery (SFA) blood flow (Doppler ultrasound) was assessed at rest and during steady-state rhythmic handgrip (RHG; 1:1 duty cycle, 40% maximal voluntary contraction), one-leg cycling (17 ± 3% peak power output), and concurrent exercise at the same intensities. During  visit 2 , MSNA (contralateral fibular nerve microneurography) was acquired successfully in 12/35 participants during the same exercise modes. SFA blood flow increased during RHG ( P  < 0.0001) and concurrent exercise ( P  = 0.03) but not cycling ( P  = 0.91). SFA vascular conductance was unchanged during RHG ( P  = 0.88) but reduced similarly during concurrent and cycling exercise (both  P  < 0.003). RHG increased MSNA burst frequency ( P  = 0.04) without altering burst amplitude ( P  = 0.69) or total MSNA ( P  = 0.26). In contrast, cycling and concurrent exercise had no effects on MSNA burst frequency (both  P  ≥ 0.10) but increased burst amplitude (both  P  ≤ 0.001) and total MSNA (both  P  ≤ 0.007). Across all exercise modes, the changes in MSNA burst amplitude and SFA vascular conductance were correlated negatively ( r  = -0.43,  P  = 0.02). In summary, the functional vascular consequences of alterations in sympathetic outflow to skeletal muscle are most closely associated with changes in MSNA burst amplitude, but not frequency, during low-intensity dynamic exercise. NEW & NOTEWORTHY  Low-intensity small- versus large-muscle mass exercise can elicit divergent effects on muscle sympathetic nerve activity (MSNA). We examined the relationships between changes in MSNA (burst frequency and amplitude) and superficial femoral artery (SFA) vascular conductance during rhythmic handgrip, one-leg cycling, and concurrent exercise in the inactive leg. Only changes in MSNA burst amplitude were inversely associated with SFA vascular conductance responses. This result highlights the functional importance of measuring MSNA burst amplitude during exercise.",2019,SFA blood flow increased during RHG ( P <0.0001) and concurrent exercise ( P =0.03) but not cycling ( P =0.91).,['Thirty-five participants completed two study visits in a randomized order'],"['dynamic arm and leg exercise', 'small vs. large muscle mass dynamic exercise', 'muscle sympathetic nerve activity (MSNA']","['SFA blood flow', 'burst amplitude (Both,  P ≤0.001) and total MSNA', 'total MSNA', 'vascular conductance and MSNA responses', 'changes in MSNA burst amplitude and SFA vascular conductance', 'RHG increased MSNA burst frequency', 'MSNA burst frequency', 'muscle sympathetic nerve activity and vascular conductance', 'SFA vascular conductance', 'superficial femoral artery (SFA) blood flow (Doppler ultrasound']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises (regime/therapy)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}]",35.0,0.0536675,SFA blood flow increased during RHG ( P <0.0001) and concurrent exercise ( P =0.03) but not cycling ( P =0.91).,"[{'ForeName': 'Connor J', 'Initials': 'CJ', 'LastName': 'Doherty', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Trevor J', 'Initials': 'TJ', 'LastName': 'King', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Incognito', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Shepherd', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Cacoilo', 'Affiliation': 'Department of Kinesiology, University of Guelph-Humber, Toronto, Ontario, Canada.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Slysz', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Millar', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00997.2018']
977,32435057,"Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design.","BACKGROUND


Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction.
METHODS


In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue.
RESULTS


During 2014-2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: -1.1-4.3]) or 6 months (0.3 [95% CI: -2.6-3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3-3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: -0.6-13.3]). There were no serious adverse events.
CONCLUSIONS


Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue.
CLINICAL TRIAL REGISTRATION


The study was registered with ISRCTN (38480455) and is completed.",2020,Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]).,"['older patient group with osteolytic bone destruction', 'During 2014-2016, 131 participants', 'patients with clinical fatigue', 'multiple myeloma survivors (MASCOT', 'multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only', 'multiple myeloma survivors']","['usual care or a 6-month exercise programme of tailored aerobic and resistance training', 'exercise intervention', 'usual care']","['Muscle strength', 'fatigue', 'cardiovascular fitness', 'FACIT-F fatigue score', 'Fatigue, quality of life and physical fitness', 'fatigue with exercise', 'safe and improved muscle strength and cardiovascular fitness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0238790', 'cui_str': 'Bone destruction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003023', 'cui_str': 'Angola'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",131.0,0.234799,Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]).,"[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Land', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Heinrich', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McCourt', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Philpott', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dunnya', 'Initials': 'D', 'LastName': 'DeSilva', 'Affiliation': 'Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rismani', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Rabin', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Charalampia', 'Initials': 'C', 'LastName': 'Kyriakou', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Papanikolaou', 'Affiliation': 'Department of Haematology, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Paton', 'Affiliation': 'Institute of Sport, Exercise and Health, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Kwee L', 'Initials': 'KL', 'LastName': 'Yong', 'Affiliation': 'Cancer Institute, University College London, London, UK. kwee.yong@ucl.ac.uk.'}]",British journal of cancer,['10.1038/s41416-020-0866-y']
978,31892500,Advertising Placement in Digital Game Design Influences Children's Choices of Advertised Snacks: A Randomized Trial.,"BACKGROUND


Children are inhabitants of a media-rich environment rife in extensive, sophisticated, and persistent techniques that are used to market unhealthy food. Exposure is known to influence children's attitudes, choices, and consumption, yet further research is required to explore the influence of contemporary techniques within online games.
OBJECTIVE


To explore the influence of modern advertising on children's attitudes, choices, and consumption, techniques (ie, banner advertising, advergame, and rewarded video advertising) were used to promote an unfamiliar confectionery brand within an online game.
DESIGN


A between-subjects randomized experimental study.
PARTICIPANTS/SETTING


Children (aged 7 to 12 years [n=156]) were recruited in New South Wales, Australia, between September and November 2017.
INTERVENTION


Children were required to play a 4-minute online game, complete some questionnaires, and choose one snack to consume afterward. Children were randomly assigned to one of four conditions: a control group with no advertising, and three experimental conditions that promoted an unfamiliar confectionery brand via a banner advertisement, advergame, or rewarded video advertisement.
MAIN OUTCOME MEASURES


Questionnaires included the assessment of attitudes to the test brand before and after the game, enjoyment of the game, and children's awareness of advertising. Food choice was recorded and food consumption was measured by weighing the snack in grams, which was translated into kilocalories.
STATISTICAL ANALYSES PERFORMED


Statistical tests included analyses of variance, Kruskal-Wallis test, and χ 2  test.
RESULTS


Attitudes toward the perception of fun (P=0.06) and taste (P=0.21) of the test brand were not influenced by condition. Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002). Condition did not influence overall energy intake measured in grams (P=0.78) or kilocalories (P=0.46).
CONCLUSIONS


Children's choice of the test brand was significantly influenced by the rewarded video advertising condition (compared with control, banner advertising, and advergame conditions). This technique is prevalent across online and application games that children play yet the effects of using rewarded video advertising to promote food brands have not been explored from a public health perspective. This study contributes to the understanding of modern strategies used to market unhealthy foods to children.",2020,Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002).,"[""Children's Choices of Advertised Snacks"", 'Children (aged 7 to 12 years [n=156]) were recruited in New South Wales, Australia, between September and November\xa02017']","['control group with no advertising, and three experimental conditions that promoted an unfamiliar confectionery brand via a banner advertisement, advergame, or rewarded video advertisement']","['food consumption', 'overall energy intake', ""enjoyment of the game, and children's awareness of advertising""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0006855', 'cui_str': 'Confection'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.0574607,Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002).,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Yeatman', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Baur', 'Affiliation': ''}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Boyland', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.07.017']
979,31349833,"Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial.","BACKGROUND


Various noninvasive respiratory support modalities are available in neonatal critical care in order to minimize invasive ventilation. Continuous positive airway pressure (CPAP) is the more commonly used but noninvasive positive pressure ventilation (NIPPV) seems more efficacious in the early post-extubation phase, although it is not clear if NIPPV may influence longterm outcomes. A recently introduced alternative is noninvasive high frequency oscillatory ventilation (NHFOV) which might be especially useful in babies needing high constant distending pressure. Preterm neonates may receive these respiratory supports for several weeks. Nonetheless, no data are available for the longterm use of NIPPV and NHFOV; few data exist on NHFOV and clinical outcomes, although its safety and suitability are reported in a number of preliminary short-term studies.
METHODS


We designed an assessor-blinded, multicenter, three-arms, parallel, pragmatic, randomized, controlled trial with a superiority design, investigating the use of CPAP vs NIPPV vs NHFOV during the whole stay in neonatal intensive care units in China. Since safety data will also be analyzed it may be considered a phase II/III trial. Moreover, subgroup analyses will be performed on patients according to prespecified criteria based on physiopathology traits: these subgroup analyses should be considered preliminary. At least 1440 neonates are supposed to be enrolled. The trial has been designed with the collaboration of international colleagues expert in NHFOV, who will also perform an interim analysis at the about 50% of the enrolment.
DISCUSSION


The study is applying the best trial methodology to neonatal ventilation, a field where it is often difficult to do so for practical reasons. Nonetheless, ours is also a physiology-driven trial, since interventions are applied based on physiological perspective, in order to use ventilatory techniques at their best. The pragmatic design will increase generalizability of our results but subgroup analyses according to predefined physiopathological criteria are also previewed trying to have some advantages of an explanatory design. Since not all clinicians are well versed in all respiratory techniques, the training is pivotal. We intend to apply particular care to train the participating units: a specific 3-month period and several means have been dedicated to this end.
TRIAL REGISTRATION


NCT03181958 (registered on June 9, 2017).",2019,A recently introduced alternative is noninvasive high frequency oscillatory ventilation (NHFOV) which might be especially useful in babies needing high constant distending pressure.,"['neonatal intensive care units in China', 'preterm neonates', 'Preterm neonates', 'babies needing high constant distending pressure', 'At least 1440 neonates']","['noninvasive positive pressure ventilation (NIPPV', 'Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV', 'CPAP vs NIPPV vs NHFOV', 'Continuous positive airway pressure (CPAP']",[],"[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4517576', 'cui_str': 'One thousand four hundred and forty'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation (procedure)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C2718088', 'cui_str': 'High-Frequency Oscillation Ventilation'}]",[],,0.213993,A recently introduced alternative is noninvasive high frequency oscillatory ventilation (NHFOV) which might be especially useful in babies needing high constant distending pressure.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Department of Neonatology, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, 400014, China.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'De Luca', 'Affiliation': 'Division of Pediatrics and Neonatal Critical Care, ""A.Béclère"" Medical Center, South Paris University Hospitals, AP-HP, Paris, France. dm.deluca@icloud.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-019-1625-1']
980,31219772,Effects of caffeine and sex on muscle performance and delayed-onset muscle soreness after exercise-induced muscle damage: a double-blind randomized trial.,"The present study aims to investigate effects of caffeine ingestion and sex difference on muscle performance, delayed-onset muscle soreness (DOMS), and various biomarkers under exercise-induced muscle damage (EIMD). Twenty (10 male and 10 female) healthy elite college athletes were recruited. Participants ingested either caffeine (6 mg/kg) or a placebo in a randomized, double-blind, and counterbalanced fashion at 24 and 48 h following EIMD. Muscle performance, DOMS, and blood samples were taken an hour before and an hour after supplementation. Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%, both  P  < 0.05) during EIMD across both sexes. Following caffeine ingestion during MVIC, while affected by EIMD, an interaction was found in DOMS and serum K +  (both  P  < 0.05), with males showing greater attenuation (21.5 and 16.9%, respectively) compared with females (4.6 and 1.3%, respectively). DOMS demonstrated an inverse correlation with MVIC after caffeine ingestion both overall and among male athletes ( r =  -0.34 and -0.54, respectively;  P  < 0.05) but not among female athletes ( r =  -0.11;  P  > 0.05) under EIMD. In addition, caffeine ingestion increased postexercise serum glucose and lactate concentrations across both sexes (both  P  < 0.05). This is the first study to show that male athletes, compared with female athletes, experience a greater reduction in DOMS during enhanced MVIC when caffeine was consumed, suggesting men might receive greater ergogenic effects from caffeine when affected by EIMD. Furthermore, caffeine ingestion was able to restore impaired muscle power among elite collegiate athletes across both sexes. NEW & NOTEWORTHY  Exercise-induced muscle damage (EIMD) reduces anaerobic/aerobic performance and increases delayed-onset muscle soreness (DOMS) during exercise. We show that acute caffeine supplementation at a dosage of 6 mg/kg seems to facilitate recovery of anaerobic muscle power and attenuate DOMS after EIMD across both sexes. Furthermore, male athletes, compared with female athletes, when caffeine was prescribed, experience a greater reduction in DOMS with better restoration of impaired maximal voluntary isometric contractions. This suggests that male athletes might benefit from the ergogenic effect of acute caffeine supplementation after the onset of EIMD.",2019,"Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%) (both,  p <.05) during EIMD across both sexes.","['Twenty (10 male and 10 female) healthy elite college athletes', 'male athletes']","['placebo', 'caffeine', 'Caffeine ingestion', 'caffeine and sex', 'caffeine ingestion']","['muscle performance and delayed onset muscle soreness', 'post-exercise serum glucose, and lowered lactate concentrations', 'maximal voluntary isometric contractions', 'Muscle performance, DOMS and blood samples', 'muscle performance, delayed onset muscle soreness (DOMS) and various biomarkers under exercise-induced muscle damage (EIMD', 'DOMS and serum K ']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.206088,"Caffeine ingestion restored impaired maximal voluntary isometric contractions (MVIC: 10.2%; MVIC post : 7.2%) (both,  p <.05) during EIMD across both sexes.","[{'ForeName': 'Hou-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Education Center for Humanities and Social Sciences, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Tung', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Han', 'Initials': 'HH', 'LastName': 'Chao', 'Affiliation': 'Department of Athletics, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ho-Seng', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01108.2018']
981,2005163,The treatment of Colles' fracture. Immobilisation with the wrist dorsiflexed.,"In a prospective study, 204 consecutive patients with displaced Colles' fractures had closed reduction then plaster immobilisation. Three different positions of the wrist in plaster were randomly allocated: palmar flexion, neutral and dorsiflexion. The results in the three groups were compared. Fractures immobilised with the wrist in dorsiflexion showed the lowest incidence of redisplacement, especially of dorsal tilt, and had the best early functional results. Immobilisation of the wrist in palmar flexion has a detrimental effect on hand function; it is suggested that it is also one of the main causes for redisplacement of the fracture. This is discussed in relation to the functional anatomy of the wrist and the mechanics of plaster fixation.",1991,"Fractures immobilised with the wrist in dorsiflexion showed the lowest incidence of redisplacement, especially of dorsal tilt, and had the best early functional results.","[""204 consecutive patients with displaced Colles' fractures had closed reduction then plaster immobilisation""]","['palmar flexion, neutral and dorsiflexion']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",[],204.0,0.0118209,"Fractures immobilised with the wrist in dorsiflexion showed the lowest incidence of redisplacement, especially of dorsal tilt, and had the best early functional results.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'LNJP Hospital, New Delhi, India.'}]",The Journal of bone and joint surgery. British volume,[]
982,31651944,Mini-extracorporeal circulation surgery produces less inflammation than off-pump coronary surgery.,"OBJECTIVES


Both off-pump coronary artery bypass grafting surgery (OPCABG) and mini-extracorporeal circulation (MECC) have been associated with lower morbidity and mortality and less inflammation than conventional cardiopulmonary bypass. However, studies comparing the 2 techniques are scarce and the results are controversial. We compared the clinical outcomes and inflammatory response of low-risk patients undergoing coronary bypass grafting with MECC versus OPCABG.
METHODS


We conducted a prospective, randomized study in patients undergoing coronary heart surgery. Two hundred and thirty consecutive low-risk patients were randomly assigned to either receive OPCABG (n = 117) or MECC (n = 113). Clinical outcomes and postoperative biochemical results were analysed in both groups. We also analysed 19 circulating inflammatory markers in a subgroup of 40 patients at 4 perioperative time points. The area under the curve for each marker was calculated to monitor differences in the inflammatory response.
RESULTS


No significant differences were found between groups regarding perioperative clinical complications and no deaths occurred during the trial. Plasma levels in 9 of the 19 inflammatory markers were undetectable or showed no temporal variation, 3 were higher in the MECC group [interleukin (IL)-10, macrophage inflammatory protein-1β and epidermal growth factor] and 7 were higher in the OPCABG group (growth regulator oncogene, IL-6, IL-8, soluble CD40 ligand, monocyte chemoattractant protein-1, monocyte chemoattractant protein-3 and tumour necrosis factor-α). Differences in 2 proinflammatory cytokines, IL-6 and monocyte chemoattractant protein 1, between the 2 surgical procedures were statistically significant.
CONCLUSIONS


No clinical differences were observed between in low-risk patients undergoing MECC or OPCABG surgery, but OPCABG was associated with an increased release of proinflammatory cytokines compared with MECC. Studies in larger cohorts and in patients at higher risk are needed to confirm these findings.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02118025.",2020,"Differences in 2 proinflammatory cytokines, IL-6 and monocyte chemoattractant protein 1, between the 2 surgical procedures were statistically significant.
","['Two hundred and thirty consecutive low-risk patients', 'low-risk patients undergoing coronary bypass grafting with MECC versus OPCABG', 'patients undergoing coronary heart surgery', '19 circulating inflammatory markers in a subgroup of 40 patients at 4 perioperative time points']","['pump coronary artery bypass grafting surgery (OPCABG) and mini-extracorporeal circulation (MECC', 'Mini-extracorporeal circulation surgery', 'OPCABG', 'MECC']","['macrophage inflammatory protein-1β and epidermal growth factor', 'perioperative clinical complications and no deaths', '2 proinflammatory cytokines, IL-6 and monocyte chemoattractant protein', 'Plasma levels', 'release of proinflammatory cytokines']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0600561', 'cui_str': 'MEKC'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}, {'cui': 'C0600561', 'cui_str': 'MEKC'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",230.0,0.0734678,"Differences in 2 proinflammatory cytokines, IL-6 and monocyte chemoattractant protein 1, between the 2 surgical procedures were statistically significant.
","[{'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Permanyer', 'Affiliation': 'Department of Cardiac Surgery, Quironsalud Teknon Heart Institute, Barcelona, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Munoz-Guijosa', 'Affiliation': 'Department of Cardiac Surgery, University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Padró', 'Affiliation': 'Department of Cardiac Surgery, Hospital de la Santa Creu i Sant Pau, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ginel', 'Affiliation': 'Department of Cardiac Surgery, Hospital de la Santa Creu i Sant Pau, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Montiel', 'Affiliation': 'Department of Cardiac Surgery, Hospital de la Santa Creu i Sant Pau, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Sánchez-Quesada', 'Affiliation': 'Cardiovascular Research Group, CIBERDEM, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vila', 'Affiliation': 'Laboratory of Angiology, Vascular Biology and Inflammation, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Camacho', 'Affiliation': 'Laboratory of Angiology, Vascular Biology and Inflammation, Research Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz291']
983,32433165,Effect of Different 131I Dose Strategies for Treatment of Hyperthyroidism on Graves' Ophthalmopathy.,"PURPOSE


The study aims to define the effect of different dose strategies on ophthalmic complications in patients with Graves' disease (GD).
METHODS


All the patients with GD and no or inactive ophthalmopathy (clinical activity score; CAS < 3) underwent Snellen chart examination, measurement of proptosis, thyroid volume, and radioactive iodine uptake, and randomized into 1 of 3 groups. In group 1, all the patients received fixed low dose (FLD) of 259 MBq of I, whereas in group 2, all the patients received fixed high dose (FHD) of 555 MBq, and in group 3, calculated dose (CD) was administered to deliver 5.55 MBq/g (thyroid weight) of I. All examinations were repeated 6 months after treatment. The measurement of thyroid function tests and clinical examination were repeated after 12 months.
RESULTS


We studied 92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years. Overall, 29, 32, and 31 patients were studied in FLD, FHD, and CD groups, respectively. The patients in CD received a mean activity of 240.5 MBq. The 3 groups were not significantly different regarding age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis. The response rate 12 months after radioactive iodine therapy was 66.7%, 94.4%, and 92.9% in FLD, FHD, and CD groups, respectively (P = 0.05). Overall, CAS was increased significantly after treatment. Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05). The highest increment in proptosis was seen in FHD group.
CONCLUSIONS


The administration of 5.55 MBq/g of I has fewer ophthalmic complications compared with high fixed dose model and is more effective than low fixed dose strategy.",2020,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"['92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years', ""patients with Graves' disease (GD""]",['radioactive iodine therapy'],"['Delta proptosis and delta CAS', 'response rate', 'ophthalmic complications', 'age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis', 'CAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0203610', 'cui_str': 'Teleradiotherapy with iodine-125'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0203778', 'cui_str': 'Radionuclide imaging of thyroid using iodine radioisotope'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",92.0,0.0359855,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"[{'ForeName': 'Shahrara', 'Initials': 'S', 'LastName': 'Ariamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Narjess', 'Initials': 'N', 'LastName': 'Ayati', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mazloum Khorasani', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mousavi', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kiavash', 'Affiliation': 'Ophthalmology Department, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Seyed Rasoul', 'Initials': 'SR', 'LastName': 'Zakavi', 'Affiliation': 'From the Nuclear Medicine Research Center.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003086']
984,2005165,Bipolar hemiarthroplasty for subcapital fracture of the femoral neck. A prospective randomised trial of cemented Thompson and uncemented Moore stems.,"We performed a randomised prospective trial to compare the results of 27 cemented and 26 uncemented bipolar hemiarthroplasties in active patients with displaced subcapital fractures of the femoral neck. After a mean follow-up of 17 months, significantly more of the uncemented group were experiencing pain in the hip and using more walking aids than the patients in the cemented group. The incidence of postoperative complications, the early mortality rate and the operating time and blood loss were not significantly different. Using otherwise identical prostheses the early results were much better with a cemented Thompson stem than with an uncemented Austin Moore stem.",1991,Using otherwise identical prostheses the early results were much better with a cemented Thompson stem than with an uncemented Austin Moore stem.,"['subcapital fracture of the femoral neck', '27 cemented and 26 uncemented bipolar hemiarthroplasties in active patients with displaced subcapital fractures of the femoral neck']","['Bipolar hemiarthroplasty', 'cemented Thompson and uncemented Moore stems']","['experiencing pain', 'incidence of postoperative complications, the early mortality rate and the operating time and blood loss']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0443030', 'cui_str': 'Moores (qualifier value)'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",27.0,0.0383799,Using otherwise identical prostheses the early results were much better with a cemented Thompson stem than with an uncemented Austin Moore stem.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Emery', 'Affiliation': 'Black Notley Hospital, Braintree, Essex, England.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Broughton', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Bulstrode', 'Affiliation': ''}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Thomas', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
985,31301135,HLA-I Associated Adaptation Dampens CD8 T-Cell Responses in HIV Ad5-Vectored Vaccine Recipients.,"HLA-I-associated human immunodeficiency virus (HIV) adaptation is known to negatively affect disease progression and CD8 T-cell responses. We aimed to assess how HLA-I-associated adaptation affects HIV vaccine-induced CD8 T-cell responses in 2 past vaccine efficacy trials. We found that vaccine-encoded adapted epitopes were less immunogenic than vaccine-encoded nonadapted epitopes, and adapted epitope-specific responses were less polyfunctional than nonadapted epitope-specific responses. Along those lines, vaccine recipients with higher HLA-I adaptation to the Gag vaccine insert mounted less polyfunctional CD8 T-cell responses at the protein level. Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation. These findings suggest that HLA-I-associated adaptation is an important consideration for strategies aiming to induce robust CD8 T-cell responses.",2019,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.",['HIV Ad5-Vectored Vaccine Recipients'],[],"['polyfunctional CD8 T-cell responses', 'HLA-I Associated Adaptation Dampens CD8 T-Cell Responses']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],"[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.017682,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.","[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Boppana', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sterrett', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Files', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz368']
986,31858116,"Persistence of Immune Responses With an Inactivated Japanese Encephalitis Single-Dose Vaccine, JENVAC and Interchangeability With a Live-Attenuated Vaccine.","BACKGROUND


This study reports immunogenicity, safety, and interchangeability of a single-dose, inactivated, Vero-cell derived, JENVAC to the live-attenuated SA 14-14-2 vaccine in healthy children.
METHODS


This phase 4, multicenter, open-label, randomized, control trial enrolled 360 children who were equally randomized to receive a single dose of either JENVAC or SA 14-14-2. Children were followed at various time points, until 2 years (day 720) postvaccination, upon which a subset from each group was divided and allocated to a receive a booster dose or the other vaccine.
RESULTS


At all time points, immunological measures were statistically higher in the JENVAC group. In the interchangeability study, children receiving 2 doses of JENVAC reported significantly higher response compared with 2 doses of SA 14-14-2. No difference in adverse events was observed. These corroborate with excellent seroprotection after the first dose of an earlier JENVAC study.
CONCLUSIONS


A single-dose vaccination with JENVAC induces protective titers that persist up to 1 year. We report appreciable interchangeability between both vaccines, with JENVAC/JENVAC combination exhibiting the highest immune response. JENVAC is now licensed as a single-dose Japanese encephalitis vaccine.",2020,"At all time points, immunological measures were statistically higher in the JENVAC® group.","['healthy children', '360 children']","['Inactivated Japanese Encephalitis single-dose vaccine JENVAC®', 'inactivated Vero-cell derived, JENVAC®', 'JENVAC®', 'JENVAC® or SA']","['protective titres', 'immunological measures', 'adverse events']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0014057', 'cui_str': 'Viral Encephalitis, Japanese B'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}]","[{'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",360.0,0.131333,"At all time points, immunological measures were statistically higher in the JENVAC® group.","[{'ForeName': 'Krishna Mohan', 'Initials': 'KM', 'LastName': 'Vadrevu', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India.'}, {'ForeName': 'Venugopal', 'Initials': 'V', 'LastName': 'Potula', 'Affiliation': 'King George Hospital, Maharanipeta, Vishakhapatnam, India.'}, {'ForeName': 'Vasant', 'Initials': 'V', 'LastName': 'Khalatkar', 'Affiliation': 'Colours Children Hospital, Jasleen, Pachsheel Square, Nagpur, India.'}, {'ForeName': 'Niranjana S', 'Initials': 'NS', 'LastName': 'Mahantshetty', 'Affiliation': 'KLE Hospital, Belgavi, India.'}, {'ForeName': 'Atish', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Sangini Hospital, Ahmedabad, India.'}, {'ForeName': 'Raches', 'Initials': 'R', 'LastName': 'Ella', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz672']
987,32433138,Modeling Medical Education: The Impact of Three-Dimensional Printed Models on Medical Student Education in Plastic Surgery.,"PURPOSE


Trainee exposure to craniofacial pathology can be limited due to rare disease presentation, revealing a need for tools that assist in visualizing complex 3D pathologic anatomy. 3D-printed models show potential as a useful aid, allowing for physical manipulation and hands-on experience. This study investigates their educational value in teaching craniofacial pathology and surgical repair.
METHODS


Forty-four medical students randomly assigned to a control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair. The model group was also provided with 3D-printed models of sagittal, metopic, and bicoronal synostosis, created using patient-specific preoperative computed tomography data. A survey using the Likert scale evaluated participants' learning experience. Pre- and postmodule scores on a 10-question multiple choice quiz were recorded.
RESULTS


The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = 0.0064), gaining an improved understanding of surgical approach (4.38 ± 0.37 versus 3.83 ± 0.29; P = 0.0266), which was more effectively taught (4.24 ± 0.33 versus 3.30 ± 0.38; P = 0.0007) with the 3D-printed models. The mean pre- and post-module quiz scores between groups were similar.
CONCLUSION


3D-printed models demonstrated an improved learning experience for medical students as shown by survey. These findings suggest a potential use for 3D-printed models in medical education of craniofacial pathology and surgery.",2020,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"['Medical Student Education in Plastic Surgery', 'Modeling Medical Education', 'Forty-four medical students']",['control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair'],"['learning experience', 'mean pre- and post-module quiz scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.0201991,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"[{'ForeName': 'Jaina C', 'Initials': 'JC', 'LastName': 'Lane', 'Affiliation': 'Department of Plastic Surgery, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Black', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006567']
988,32103358,Pre-post analysis of a social capital-based exercise adherence intervention for breast cancer survivors with moderate fatigue: a randomized controlled trial.,"PURPOSE


This study assessed the effectiveness of the Better Life After Cancer: Energy, Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program for breast cancer survivors (BCS), regarding cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics.
METHODS


Forty-eight BCS with moderate or high (≥ 4) CRF participated in this randomized control trial (intervention group n = 23, control group n = 25). The intervention group participated in small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises. The control group was only given written information on exercise. A questionnaire was used to assess CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital.
RESULTS


The majority of participants had undergone surgery less than 2 years ago. After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group. Both groups showed improvements in sleep quality, depression, anxiety, and QOL.
CONCLUSION


The BLESS program decreased behavioral/severity in the CRF and increased physical activity after 12 weeks among BCS. Future research needs to evaluate whether the promising results on physical activity and behavioral fatigue observed in the short term will persist over time. Also, longer-term effects should be examined.",2020,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","['breast cancer survivors with moderate fatigue', 'breast cancer survivors (BCS', 'Forty-eight BCS with moderate or high (≥\u20094']","['CRF', 'Strength, and Support (BLESS) program, a 12-week social capital-based exercise adherence program', 'social capital-based exercise adherence intervention', 'small group sessions to activate social capital while targeting CRF in supervised physical exercises supplemented by home-based physical exercises']","['physical activity', 'physical activity and behavioral fatigue', 'sleep quality, depression, anxiety, and QOL', 'cancer-related fatigue (CRF), quality of life (QOL), physical activity, and psychosocial characteristics', 'CRF behavioral/severity domain', 'behavioral/severity', 'CRF, QOL, physical activity, depression, anxiety, sleep quality, and social capital']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}]",48.0,0.0337544,"After participating in BLESS, the CRF behavioral/severity domain significantly decreased (t = 2.642, p = 0.011) and physical activity significantly increased (t = - 2.049, p = 0.046) in the intervention group, in comparison with the control group; there were no significant post-intervention differences in the control group.","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Yoonkyung', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Justin Y', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Young Up', 'Initials': 'YU', 'LastName': 'Cho', 'Affiliation': 'Formerly affiliated with Yonsei University Health System, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea.'}, {'ForeName': 'Gihong', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Sociology, Hallym University, 1, Hallymdaehak-gil, Chuncheon-si, Gangwon-do, 24252, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Korea. hjihee1225@hanmail.net.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05363-7']
989,31486721,Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer: A Study Protocol.,"Introduction:  Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer. The aims of this trial are to compare the effect of delivering early integrated PC through telehealth versus in-person on patient and caregiver outcomes. We hypothesize that both modalities for delivering early PC would be equivalent for improving patient QOL, communication about EOL care preferences with their oncologist, and length of stay in hospice.  Methods:  For this comparative effectiveness trial, we will enroll and randomize 1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States. Patients may also invite a family caregiver to participate in the study. Patients and their caregivers in both study groups meet at least every four weeks with a PC clinician from within 12 weeks of patient diagnosis of advanced NSCLC until death. Participants complete measures of QOL, mood, and quality of communication with oncologists at baseline before randomization and at 12, 24, 36, and 48 weeks. Information on health care utilization, including length of stay in hospice, will be collected from patients' health records. To test equivalence in outcomes between study groups, we will compute analysis of covariance and mixed linear models, controlling for baseline scores and study site.  Study Implementation and Stakeholder Engagement:  To ensure that this comparative effectiveness trial and findings are as patient centered and meaningful as possible, we have incorporated a robust patient and stakeholder engagement plan. Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates. These stakeholders will inform and provide feedback about every phase of study implementation.",2019,"Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer.","['Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates', 'Patients with Advanced Lung Cancer', '1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States', 'patients with advanced lung cancer']",['Early Integrated Telehealth versus In-Person Palliative Care'],"['length of stay in hospice', 'quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care', 'QOL, mood, and quality of communication with oncologists']","[{'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0242170', 'cui_str': 'Policy Makers'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",1250.0,0.0835891,"Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer.","[{'ForeName': 'Isaac S', 'Initials': 'IS', 'LastName': 'Chua', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Finly', 'Initials': 'F', 'LastName': 'Zachariah', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Feliciano', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hanson', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Blackhall', 'Affiliation': 'University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Quest', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Curseen', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Grey', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, North Carolina.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shoemaker', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Silveira', 'Affiliation': 'Michigan Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Mahony"", 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kostantinos', 'Initials': 'K', 'LastName': 'Leventakos', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Chardria', 'Initials': 'C', 'LastName': 'Trotter', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Sereno', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0210']
990,31846094,"Health utility of rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation.","OBJECTIVES


Advanced nasal malignancies may require rhinectomy, which can have profound psychosocial impacts. Rhinectomy defects can be rehabilitated through surgery or prosthetics. We seek to understand the health utility of the rhinectomy defect, surgical, and prosthetic reconstruction, which have not been previously studied.
STUDY DESIGN


Prospective clinical study METHODS: Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation). Health utilities were measured using visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO). One-way analysis of variance (ANOVA) with post hoc Scheffe's test and the independent samples T-test for a priori comparisons were performed. Multiple linear regression was performed using participant demographics as independent predictors of utility scores.
RESULTS


Health utilities (VAS, SG, TTO) were reported as follows (mean ± SD): monocular blindness (0.71 ± 0.21, 0.84 ± 0.20, 0.85 ± 0.19), binocular blindness (0.48 ± 0.25, 0.68 ± 0.28, 0.63 ± 0.28), post-rhinectomy nasal defect (0.59 ± 0.24, 0.74 ± 0.24, 0.74 ± 0.24), postsurgical reconstruction (0.88 ± 0.16, 0.90 ± 0.18, 0.89 ± 0.13), and post-prosthetic rehabilitation (0.67 ± 0.22, 0.80 ± 0.23, 0.82 ± 0.20). Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility. SG and TTO utility scores were inversely associated with observer age (P < .001) and participants who identified themselves as non-Caucasians (P < .05) in post-rhinectomy nasal defect, post-nasal surgical reconstruction, and post-nasal prosthetic rehabilitation health states, while higher levels of education were directly associated with SG scores (P < .05), respectively.
CONCLUSION


This is the first study to demonstrate the significant negative impact of the rhinectomy nasal defect on health utility. Rehabilitation by surgical or prosthetic techniques significantly increases health utility as rated by naïve observers. Laryngoscope, 130:1674-1679, 2020.",2020,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"['Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation']","['rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation']","['prosthetic rehabilitation', 'SG scores', 'visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO', 'Health utilities (VAS, SG, TTO', 'postsurgical reconstruction', 'SG and TTO utility scores', 'Health utilities', 'health utility', 'binocular blindness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0750958', 'cui_str': 'Blindness, Monocular'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",,0.0331634,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"[{'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Faris', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Heiser', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Quatela', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Otolaryngology Head & Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tessler', 'Affiliation': 'Elite Plastic Surgery, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Jowett', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Linda N', 'Initials': 'LN', 'LastName': 'Lee', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28480']
991,31488225,Portion size normality and additional within-meal food intake: two crossover laboratory experiments.,"Reducing food portion size could reduce energy intake. However, it is unclear at what point consumers respond to reductions by increasing intake of other foods. We predicted that a change in served portion size would only result in significant additional eating within the same meal if the resulting portion size was no longer visually perceived as 'normal'. Participants in two crossover experiments (Study 1: n 45; Study 2: n 37; adults, 51 % female) were served different-sized lunchtime portions on three occasions that were perceived by a previous sample of participants as 'large-normal', 'small-normal' and 'smaller than normal', respectively. Participants were able to serve themselves additional helpings of the same food (Study 1) or dessert items (Study 2). In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared with the 'small-normal' portion (m difference = 161 kJ, P = 0·002, d = 0·35), but there was no significant difference between the 'small-normal' and 'large-normal' conditions (m difference = 88 kJ, P = 0·08, d = 0·24). A similar pattern was observed in Study 2 (m difference = 149 kJ, P = 0·06, d = 0·18; m difference = 83 kJ, P = 0·26, d = 0·10). However, smaller portion sizes were each associated with a significant reduction in total meal intake. The findings provide preliminary evidence that reductions that result in portions appearing 'normal' in size may limit additional eating, but confirmatory research is needed.",2020,"In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared to the 'small-normal' portion, m difference = 39 kcal, p = .002","['Participants in two crossover experiments (Study 1: N = 45; Study 2: N = 37; adults, 51% female']",[],"['total meal intake', 'energy intake', 'additional intake', ""small-normal' and 'large-normal' conditions""]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.108882,"In Study 1 there was a small but significant increase in additional intake when participants were served the 'smaller than normal' compared to the 'small-normal' portion, m difference = 39 kcal, p = .002","[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Hardman', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}]",The British journal of nutrition,['10.1017/S0007114519002307']
992,31950156,Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Sellar and Parasellar Tumor Resection: A Multicenter Prospective Randomized Controlled Trial.,"BACKGROUND


Endoscopic endonasal approaches pose the potential risk of olfactory loss. Loss of olfaction and potentially taste can be permanent and greatly affect patients' quality of life. Treatments for olfactory loss have had limited success. Omega-3 supplementation may be a therapeutic option with its effect on wound healing and nerve regeneration.
OBJECTIVE


To evaluate the impact on olfaction in patients treated with omega-3 supplementation following endoscopic skull base tumor resection.
METHODS


In this multi-institutional, prospective, randomized controlled trial, 110 patients with sellar or parasellar tumors undergoing endoscopic resection were randomized to nasal saline irrigations or nasal saline irrigations plus omega-3 supplementation. The University of Pennsylvania Smell Identification Test (UPSIT) was administered preoperatively and at 6 wk, 3 mo, and 6 mo postoperatively.
RESULTS


Eighty-seven patients completed all 6 mo of follow-up (41 control arm, 46 omega-3 arm). At 6 wk postoperatively, 25% of patients in both groups experienced a clinically significant loss in olfaction. At 3 and 6 mo, patients receiving omega-3 demonstrated significantly less persistent olfactory loss compared to patients without supplementation (P = .02 and P = .01, respectively). After controlling for multiple confounding variables, omega-3 supplementation was found to be protective against olfactory loss (odds ratio [OR] 0.05, 95% CI 0.003-0.81, P = .03). Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
CONCLUSION


Omega-3 supplementation appears to be protective for the olfactory system during the healing period in patients who undergo endoscopic resection of sellar and parasellar masses.",2020,"Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
","['patients treated with omega-3 supplementation following endoscopic skull base tumor resection', '110 patients with sellar or parasellar tumors undergoing endoscopic resection', 'patients who undergo endoscopic resection of sellar and parasellar masses', 'Patients With Smell Dysfunction Following Endoscopic Sellar and Parasellar Tumor Resection']","['Omega-3 supplementation', 'nasal saline irrigations or nasal saline irrigations plus omega-3 supplementation', 'Omega-3 Supplementation']","['olfaction', 'protective against olfactory loss', 'persistent olfactory loss', 'olfactory loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0149543', 'cui_str': 'Cranial Base'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of Smell'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}]",110.0,0.0704208,"Tumor functionality was a significant independent predictor for olfactory loss (OR 32.7, 95% CI 1.15-929.5, P = .04).
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aakanksha', 'Initials': 'A', 'LastName': 'Rathor', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kaelyn', 'Initials': 'K', 'LastName': 'Krook', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Rotella', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Dodd', 'Affiliation': 'Department of Neurosurgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Hwang', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jayakar V', 'Initials': 'JV', 'LastName': 'Nayak', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nelson M', 'Initials': 'NM', 'LastName': 'Oyesiku', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'DelGaudio', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Levy', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Wise', 'Affiliation': 'Department of Psychology, Oglethorpe University, Atlanta, Georgia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Wise', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Zara M', 'Initials': 'ZM', 'LastName': 'Patel', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Stanford University School of Medicine, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyz559']
993,31858963,Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study.,"OBJECTIVES


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR).
METHODS


Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep.
RESULTS


Overall, 539/797 (67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients.
CONCLUSIONS


Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.",2020,"At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo.","['rheumatoid arthritis (RA', 'Patients', 'patients with active RA and inadequate responses to', 'patients with rheumatoid arthritis']","['Tofacitinib', 'methotrexate', 'placebo', 'MTX', 'tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX', 'methotrexate (MTX-IR', 'placebo advanced to tofacitinib']","['signi cant', 'Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.481424,"At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Keystone', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kremer', 'Affiliation': 'Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}, {'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Cardiel', 'Affiliation': 'Centro de Investigacion Clinica de Morelia, Mexico.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'University of Queensland, Australia.'}, {'ForeName': 'Yeong-Wook', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tegzová', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Wallenstein', 'Affiliation': 'Pfizer Inc, Groton, CT, USA. genewallenstein@yahoo.com.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Connell', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental rheumatology,[]
994,31486727,Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol.,"Introduction:  Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits. U.S. health care payment reforms create financial opportunities to offer HBPC. Consequently, more HBPC programs are emerging, heightening the need to evaluate their effectiveness.  Methods:  This randomized, controlled trial is comparing the effectiveness of an evidence-based model of HBPC and enhanced usual primary care for participants who receive primary care from medical groups and clinics organized under an accountable care organization or Medicare Advantage plan. Palliative care services are reimbursed by our partnering health plan provider. The five-year trial will enroll 1155 seriously ill participants (and ∼884 of their caregivers) with heart failure, chronic obstructive pulmonary disease, or advanced cancer. We are collecting data via telephone surveys with participants at baseline and one and two months postenrollment and with caregivers at baseline, one and two months postenrollments, and following the death of a loved one. We are collecting participant-reported outcome measures of pain, symptoms, anxiety, depression, participant-provider communication, and hope. Caregiver outcome measures include caregiver burden, communication with providers, anxiety, and depression. Additional outcomes are participant survival time and participants' emergency department visits and hospitalizations.  Study Implementation: Challenges and Contributions:  Our research team has encountered several significant challenges in early study implementation. These include engaging primary care providers in the study and coordinating logistics with a health plan. Both challenges have contributed to a lag in participant enrollment. Despite these challenges, our study holds tremendous promise to accelerate adoption and spread of an evidence-based HBPC model across the country.",2019,Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits.,"['participants who receive primary care from medical groups and clinics organized under an accountable care organization or Medicare Advantage plan', '1155 seriously ill participants (and ∼884 of their caregivers) with heart failure, chronic obstructive pulmonary disease, or advanced cancer']","['HBPC and enhanced usual primary care', 'home-based palliative care (HBPC']","['pain, symptoms, anxiety, depression, participant-provider communication, and hope', 'caregiver burden, communication with providers, anxiety, and depression', ""participant survival time and participants' emergency department visits and hospitalizations""]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organizations'}, {'cui': 'C2713369', 'cui_str': 'Medicare Advantage'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",1155.0,0.0653159,Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Enguidanos', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Torrie', 'Initials': 'T', 'LastName': 'Fields', 'Affiliation': 'Blue Shield of California, San Francisco, California.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brumley', 'Affiliation': 'Reliance Hospital and Palliative Care, Costa Mesa, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rabow', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, California.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0147']
995,31486728,Reducing Disparities in the Quality of Palliative Care for Older African Americans through Improved Advance Care Planning: Study Design and Protocol.,"Advance care planning (ACP) improves end-of-life care for patients and their caregivers. However, only one-third of adults have participated in ACP and rates are substantially lower among African Americans than among whites. Importantly, ACP improves many domains of care where there are racial disparities in outcomes, including receipt of goal-concordant care, hospice use, and provider communication. Yet, few studies have examined the effectiveness of ACP interventions among African Americans. The objectives of reducing disparities in the quality of palliative care for older African Americans through improved advance care planning (EQUAL ACP) are as follows: to compare the effectiveness of two interventions in (1) increasing ACP among African Americans and whites and (2) reducing racial disparities in both ACP and end-of-life care; and to examine whether racial concordance of the interventionist and patient is associated with ACP. EQUAL ACP  i s a longitudinal, multisite, cluster randomized trial and a qualitative study describing the ACP experience of participants. The study will include 800 adults ≥65 years of age (half African American and half white) from 10 primary care clinics in the South. Eligible patients have a serious illness (advanced cancer, heart failure, lung disease, etc.), disability in activities of daily living, or recent hospitalization. Patients are followed for one year and participate in either a patient-guided, self-management ACP approach, including a Five Wishes form or structured ACP with Respecting Choices First Steps. The primary outcome is formal or informal ACP-completion of advance directives, documented discussions with clinicians, and other written or verbal communication with surrogate decision makers about care preferences. Secondary outcomes assessed through after-death interviews with surrogates of patients who die during the study include receipt of goal-concordant care, health services use in the last year of life, and satisfaction with care. EQUAL ACP is the first large study to assess which strategies are most effective at both increasing rates of ACP and promoting equitable palliative care outcomes for seriously ill African Americans.",2019,The objectives of reducing disparities in the quality of palliative care for older African Americans through improved advance care planning (EQUAL ACP) are as follows: to compare the effectiveness of two interventions in (1) increasing ACP among African Americans and whites and (2) reducing racial disparities in both ACP and end-of-life care; and to examine whether racial concordance of the interventionist and patient is associated with ACP.,"['African Americans and whites and (2) reducing racial disparities in both ACP and end-of-life care', 'African Americans', 'Eligible patients have a serious illness (advanced cancer, heart failure, lung disease, etc.), disability in activities of daily living, or recent hospitalization', 'older African Americans', 'seriously ill African Americans', 'ACP experience of participants', 'Older African Americans', '800 adults ≥65 years of age (half African American and half white) from 10 primary care clinics in the South', 'patients and their caregivers']","['Advance care planning (ACP', 'ACP', 'advance care planning (EQUAL ACP']","['death interviews with surrogates of patients who die during the study include receipt of goal-concordant care, health services use in the last year of life, and satisfaction with care', 'formal or informal ACP-completion of advance directives, documented discussions with clinicians, and other written or verbal communication with surrogate decision makers about care preferences']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",800.0,0.0413966,The objectives of reducing disparities in the quality of palliative care for older African Americans through improved advance care planning (EQUAL ACP) are as follows: to compare the effectiveness of two interventions in (1) increasing ACP among African Americans and whites and (2) reducing racial disparities in both ACP and end-of-life care; and to examine whether racial concordance of the interventionist and patient is associated with ACP.,"[{'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Barrett', 'Affiliation': 'Deparment of Community and Family Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ramona L', 'Initials': 'RL', 'LastName': 'Rhodes', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Raegan', 'Initials': 'R', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Elk', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Care, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Deparment of Community and Family Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Quest', 'Affiliation': 'Department of Emergency Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Deparment of Community and Family Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Center for the Study of Aging and Human Development, Center for Palliative Care Duke University School of Medicine and Geriatrics Research Education and Clinical Center, Durham VA Medical Center, Durham, North Carolina.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0146']
996,31486729,Protocol for a Cluster Randomized Trial Comparing Team-Based to Clinician-Focused Implementation of Advance Care Planning in Primary Care.,"Introduction:  For many patients, primary care is an appropriate setting for advance care planning (ACP). ACP focuses on what matters most to patients and ensuring health care supports patient-defined goals. ACP may involve interactions between a clinician and a patient, but for seriously ill patients ACP could be managed by a team.  Methods:  We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs). Practices were randomized to one of the two models. Patients are referred to the study after engaging in ACP in primary care. Our target enrollment is 1260 subjects. Patient data are collected at enrollment, six months and one year. Primary outcomes are patient-reported goal-concordant care and days at home. Secondary outcomes include additional patient measures, clinician/team experience, and practice-level measures of SICP implementation.  Study Implementation:  This trial was designed and is conducted by the Meta-network Learning and Research Center (Meta-LARC), a consortium of PBRNs focused on integrating engagement with patients, families, and other stakeholders into primary care research and practice. The trial pairs a comparative effectiveness study with implementation of a new program and is designed to balance fidelity to the assigned model with flexibility to allow each practice to adapt implementation to their environment and priorities. Our dissemination will report the results of comparing the two models and the implementation experience of the practices to create guidance for the spread of ACP in primary care.",2019,We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs).,"['42 practices recruited from 7 practice-based research networks (PBRNs', '1260 subjects']","['ACP', 'clinician-focused ACP using the Serious Illness Care Program (SICP']","['additional patient measures, clinician/team experience, and practice-level measures of SICP implementation', 'patient-reported goal-concordant care and days at home']","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",1260.0,0.0420048,We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs).,"[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Totten', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Lyle J', 'Initials': 'LJ', 'LastName': 'Fagnan', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dorr', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'LeAnn C', 'Initials': 'LC', 'LastName': 'Michaels', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Shigeko Seiko', 'Initials': 'SS', 'LastName': 'Izumi', 'Affiliation': 'School of Nursing, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Combe', 'Affiliation': 'Oregon Rural Practice-Based Research Network, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de Recherche Sur Les Soins et Les Services de Première Ligne de l'Université Laval, Quebec, Canada.""}]",Journal of palliative medicine,['10.1089/jpm.2019.0117']
997,31486730,"A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).","Background:  Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  Objectives and Hypotheses:  Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients.  Methods:  Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization.  Setting:  Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020.  Participants:  Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer.  Interventions:  In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team.  Main Outcomes and Measures:  Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used.  Ethics and Dissemination:  This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).",2019,"Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  ","['patients pursuing curative-intent surgery for upper GI cancers', '8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients', 'for Patients and Their Family Members (PERIOP-PC', 'Setting:  Four, geographically diverse, academic tertiary care hospitals', 'patients with upper gastrointestinal (GI) cancers', 'Participants:  Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer']","['surgeon-PC co-management with surgeon-alone management', 'specialist palliative care (PC', 'usual care arm receive care from only the surgical team', 'Perioperative Palliative Care Surrounding Cancer Surgery']","['patient postsurgical quality of life', 'patient quality of life', 'Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness', 'symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0920424'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0920424'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0150081', 'cui_str': 'Spiritual distress (finding)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.131645,"Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers.  ","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Aslakson', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Shivani V', 'Initials': 'SV', 'LastName': 'Chandrashekaran', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rickerson', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bridget N', 'Initials': 'BN', 'LastName': 'Fahy', 'Affiliation': 'Department of Surgery, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Fabian M', 'Initials': 'FM', 'LastName': 'Johnston', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Miller', 'Affiliation': 'Patient-family partner, Ellicott City, Maryland.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conca-Cheng', 'Affiliation': 'The Warren Alpert Medical School, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Suwei', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Arden M', 'Initials': 'AM', 'LastName': 'Morris', 'Affiliation': 'Stanford-Surgery Policy Improvement Research and Education Center, Stanford University, Stanford, California.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0130']
998,2670950,Operative or conservative treatment for trochanteric fractures of the femur. A randomised epidemiological trial in elderly patients.,"All elderly patients with extracapsular hip fractures seen in hospitals in Newcastle upon Tyne over a 12-month period were studied and followed up for six months. At one of the hospitals, patients were randomised to treatment by AO dynamic hip-screw or by traction. Complications specific to the two treatments were low, and general complications, six-month mortality and prevalence of pain, leg swelling and unhealed sores, showed no difference between the two modes of treatment. Operative treatment gave better anatomical results and a shorter hospital stay, but significantly more of the patients treated by traction showed loss of independence six months after injury.",1989,"Complications specific to the two treatments were low, and general complications, six-month mortality and prevalence of pain, leg swelling and unhealed sores, showed no difference between the two modes of treatment.","['trochanteric fractures of the femur', 'All elderly patients with extracapsular hip fractures seen in hospitals in Newcastle upon Tyne', 'elderly patients']",['AO dynamic hip-screw or by traction'],"['general complications, six-month mortality and prevalence of pain, leg swelling and unhealed sores', 'Complications specific', 'shorter hospital stay']","[{'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1455785', 'cui_str': 'Sore sensation quality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0229981,"Complications specific to the two treatments were low, and general complications, six-month mortality and prevalence of pain, leg swelling and unhealed sores, showed no difference between the two modes of treatment.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hornby', 'Affiliation': 'Department of Orthopaedics, Royal Victoria Infirmary, Newcastle upon Tyne.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vardon', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
999,31498467,Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial.,"OBJECTIVES/HYPOTHESIS


Voice rest is often prescribed following phonosurgery by most surgeons despite limited empiric evidence to support its practice. This study assessed the effect of postphonosurgery voice rest on vocal outcomes.
STUDY DESIGN


Prospective, randomized controlled trial.
METHODS


Patients with unilateral vocal fold lesions undergoing CO 2  laser excision were recruited in a prospective manner and randomized into one of two groups: 1) an experimental arm consisting of 7 days of absolute voice rest, or 2) a control arm consisting of no voice rest. The primary outcome measure was the Voice Handicap Index-10 (VHI-10) questionnaire. Secondary outcomes included aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures. Primary and secondary outcomes were assessed preoperatively and reassessed postoperatively at the 1- and 3-month follow-up. Patient compliance to voice rest instructions were controlled for using subjective and objective parameters.
RESULTS


Thirty patients were enrolled with 15 randomized to each arm of the study. Statistical analysis for the entire cohort showed a significant improvement in the mean preoperative VHI-10 compared to postoperative assessments at 1-month (19.0 vs. 7.3, P < .05) and 3-month (19.0 vs. 6.2, P < .05) follow-up. However, between-group comparisons showed no significant difference in postoperative VHI-10 at either time point. Similarly, secondary outcome measures yielded no significant difference in between-group comparisons.
CONCLUSIONS


Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
LEVEL OF EVIDENCE


1b CLINICAL TRIAL NUMBER: NCT02788435 (clinicaltrials.gov) Laryngoscope, 130:1750-1755, 2020.",2020,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","['Thirty patients were enrolled with 15 randomized to each arm of the study', 'Patients with unilateral vocal fold lesions undergoing CO 2  laser excision', 'vocal fold lesions']","['absolute voice rest, or 2) a control arm consisting of no voice rest', 'postphonosurgery voice rest', 'laser resection']","['postoperative VHI-10', 'Voice Handicap Index-10 (VHI-10) questionnaire', 'mean preoperative VHI-10', 'aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time (observable entity)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.185901,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis.
","[{'ForeName': 'Sandeep S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Doyle', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Failla', 'Affiliation': 'Voice Production and Perception Laboratory, and Department of Health and Rehabilitation Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hawkins', 'Affiliation': 'Department of Speech-Language Pathology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}]",The Laryngoscope,['10.1002/lary.28287']
1000,31486103,"Vortioxetine effects on quality of life of irritable bowel syndrome patients: A randomized, double-blind, placebo-controlled trial.","WHAT IS KNOWN AND OBJECTIVE


Irritable bowel syndrome (IBS) is a functional gastrointestinal disease causing a substantial productivity loss with no definite treatment. Our study investigates the effects of vortioxetine vs placebo in enhancing the IBS patients' quality of life.
METHODS


In a double-blinded, placebo-controlled, randomized trial, adults with IBS, according to the ROME IV criteria, were randomized to placebo and vortioxetine for 6 weeks. Participants were visited every two weeks to fill IBS quality of life, hospital anxiety and depression scale, and adverse effect questionnaires.
RESULTS


Eighty patients were randomized, and seventy-two finished the trial. Baseline characteristics of groups were similar. Both placebo and vortioxetine significantly increased the quality of life during course of the study (both P-values < .001), whereas vortioxetine demonstrated a greater increase (P-value < .001). According to the analysis of covariances, this enhancement was irrespective of depression or anxiety score changes (P-value = .002). Adverse effect profile was similar between the groups and can increase IBS patients' quality of life superior to placebo. Vortioxetine effects in our study were observed irrespective of the depression and anxiety levels.",2020,"Both placebo and vortioxetine significantly increased the quality of life during course of the study (both P-values < .001), whereas vortioxetine demonstrated a greater increase (P-value < .001).","['irritable bowel syndrome patients', 'Eighty patients were randomized, and seventy-two finished the trial', 'adults with IBS, according to the ROME IV criteria']","['vortioxetine vs placebo', 'vortioxetine', 'Vortioxetine', 'placebo', 'placebo and vortioxetine']","[""IBS patients' quality of life"", 'depression and anxiety levels', 'quality of life', 'depression or anxiety score changes', 'fill IBS quality of life, hospital anxiety and depression scale, and adverse effect questionnaires', 'Adverse effect profile']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",80.0,0.604825,"Both placebo and vortioxetine significantly increased the quality of life during course of the study (both P-values < .001), whereas vortioxetine demonstrated a greater increase (P-value < .001).","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Seddighnia', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Tadayon Najafabadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kiandokht', 'Initials': 'K', 'LastName': 'Ghamari', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Ali', 'Initials': 'AA', 'LastName': 'Noorbala', 'Affiliation': 'Psychosomatic Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Ebrahimi Daryani', 'Affiliation': 'Gastroenterology and Hepatology Ward, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': 'Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13032']
1001,31483377,Impact of early antiretroviral treatment on sexual behaviour in the INSIGHT Strategic Timing of Anti-Retroviral Treatment (START) Trial.,"BACKGROUND


Antiretroviral treatment (ART) reduces HIV infectiousness, but the effect of early ART on sexual behaviour is unclear.
METHODS


We assessed, within the START randomised trial that enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART < 6 months ago or viral load(VL)>200c/mL or no VL in past 6 months), during two year follow-up. Month-12 CLS-D (2010-2014) was the primary outcome.
RESULTS


Among 2562 MSM, there was no difference between immediate and deferred arms in CLS-D at month 12 [12.6% versus 13.1%; difference (95% CI): -0.4% (-3.1%, 2.2%), p = 0.75] or month 24, or in CLS. Among 2010 heterosexual men and women, CLS-D at month 12 tended to be higher in the immediate versus deferred arm [10.8% versus 8.3%; difference:2.5% (-0.1%, 5.2%), p = 0.062]; the difference was greater at month 24 [9.3% versus 5.6%; difference:3.7%(1.0%, 6.4%), p = 0.007], at which time CLS was higher in the immediate arm [20.7% versus 15.7%, p = 0.013]. CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
CONCLUSIONS


A strategy of early ART had no effect on condomless sex with HIV-serodifferent partners among MSM, but resulted in modestly higher prevalence among heterosexuals. However, among MSM and heterosexuals, early ART resulted in a substantial reduction in HIV-transmission-risk-sex, to a very low absolute level.",2019,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","['2010 heterosexual men', 'enrolled HIV-positive adults with CD4>500/mm, the effect of early (immediate) versus']","['deferred ART on: (i) condomless sex with HIV-serodifferent partners (CLS-D); (ii) all condomless sex (CLS); (iii) HIV transmission-risk-sex (CLS-D-HIV-risk, defined as CLS-D and: not on ART or started ART\u200a<\u200a6 months ago or viral load(VL)>200c/mL or no VL']","['CLS-D-HIV-risk', 'sexual behaviour', 'time CLS']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2562.0,0.322822,"CLS-D-HIV-risk at month 12 was substantially lower in the immediate versus deferred arm for MSM [0.2% versus 11.0%; difference: -10.7% (-12.5%, -8.9%), p < 0.001] and heterosexuals [0.6% versus 7.7%; difference: -7.0% (-8.8%, -5.3%), p < 0.001], due to viral suppression on ART.
","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Lampe', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Burman', 'Affiliation': 'Denver Public Health, University of Colorado Health Sciences Center, Denver CO, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grulich', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Friedland', 'Affiliation': 'Departments of Medicine and Epidemiology, Yale School of Medicine, New Haven CT United States.'}, {'ForeName': 'Wafaa El', 'Initials': 'WE', 'LastName': 'Sadr', 'Affiliation': 'Columbia University, New York, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minnesota, United States.'}, {'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Corbelli', 'Affiliation': 'European AIDS Treatment Group, Bruxelles, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Université de Paris Diderot, Paris, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Gatell', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gerstoft', 'Affiliation': 'Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kiat', 'Initials': 'K', 'LastName': 'Ruxrungtham', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Monica Barbosa de', 'Initials': 'MB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002359']
1002,31871115,Anti-PD-L1 (atezolizumab) as an immune primer and concurrently with extended-field chemoradiotherapy for node-positive locally advanced cervical cancer.,"BACKGROUND


There is a lack of data exploring the use and optimal timing of immunotherapy and chemoradiation therapy (CRT) in node-positive cervical cancer. Further translational research into mechanisms of response and resistance to immunotherapy in advanced cervical cancer is warranted.
PRIMARY OBJECTIVES


To determine if sequencing of atezolizumab and CRT result in differential immune activation, as determined by clonal expansion of T cell receptor beta (TCRB) repertoires in peripheral blood on day 21.
STUDY HYPOTHESIS


There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B.
TRIAL DESIGN


Locally advanced cervical cancer patients with lymph node-positive disease will be randomized on this open-label, randomized trial with two experimental arms. Arm A will get one dose of atezolizumab prior to cisplatin CRT, and then two subsequent doses of atezolizumab during the CRT, and Arm B will get three doses during CRT. Patients will be followed for 2 years to assess outcomes.
MAJOR INCLUSION/EXCLUSION CRITERIA


Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes. Exclusion criteria include those who had a prior hysterectomy or lymph node dissection.
PRIMARY ENDPOINTS


Clonal expansion of TCRB) repertoires in peripheral blood on day 21.
SAMPLE SIZE


The sample size will be 40 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


We estimate accrual to finish by the summer of 2020 with presentation of results to follow in 2021.
TRIAL REGISTRATION


NCT03738228.",2020,"There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B.
","['Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes', '40 patients', 'node-positive locally advanced cervical cancer', 'Exclusion criteria include those who had a prior hysterectomy or lymph node dissection', 'advanced cervical cancer', 'node-positive cervical cancer', 'Locally advanced cervical cancer patients with lymph node-positive disease']","['Anti-PD-L1 (atezolizumab', 'immunotherapy and chemoradiation therapy (CRT', 'atezolizumab and CRT', 'atezolizumab', 'atezolizumab prior to cisplatin CRT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous cell carcinoma'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0740255', 'cui_str': 'Para-aortic lymph node group (body structure)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0229789', 'cui_str': 'Para-aortic node (body structure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.173007,"There is a difference for clonal expansion of T cell receptor beta repertoires in the peripheral blood at day 21 between the priming and concurrent atezolizumab and CRT in Arm A vs the concurrent atezolizumab and CRT in Arm B.
","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego Medical Center, La Jolla, California, USA jmayadev@ucsd.edu.'}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Zamarin', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Biostatistics and Bioinformatics, NRG Oncology, Clinical Trial Development Division, Buffalo, New York, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lankes', 'Affiliation': ""Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001012']
1003,31486722,Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial.,"Introduction:  Patients with end-stage liver disease (ESLD) suffer from myriad symptoms due to the systemic effects of the disease and unpredictable acute episodes, which contribute to progressive deterioration in quality of life (QOL). Despite clear evidence that palliative care (PC) improves QOL in other serious illnesses, PC is underutilized and delayed for ESLD patients. Through a comparative effectiveness trial of specialist led consultative PC (Model 1) versus trained hepatologist led PC (Model 2), we aim to build evidence on introducing PC into the routine outpatient care of ESLD patients.  Objective:  We hypothesize that trained hepatologist led PC model will have a better improvement in QOL compared to consultative PC model.  Methods:  This two-arm, multicenter cluster-randomized trial assesses the effectiveness of two PC models for patients with ESLD. Fourteen clinical centers will recruit 1260 patient-caregiver dyads. Each center is the unit of randomization. Hepatologists at sites randomized to the Model 2 have undergone web-based training in the principles of PC as pertained to ESLD. PC intervention is delivered over four visits (initial, one, two, and three months). Follow-up assessments occur at 6, 9, and 12 months. Eligible patients are those with new onset or ongoing complications of ESLD with a caregiver willing to participate.  Outcomes:  The primary outcome is change in patients' QOL from baseline to three months. Secondary outcomes include symptom burden, depression, distress, satisfaction with care, caregiver burden and QOL, goal concordant care, and health care utilization.  Challenges and Contributions Engagement:  A research advisory board has been developed with representatives from the participating centers, who have provided active feedback on the protocol, outcomes, study methods, and training program.  Intervention Fidelity:  Intervention fidelity will be maintained by adherence to a visit agenda and providers in both models completing a PC checklist after each study visit.",2019,Hepatologists at sites randomized to the Model 2 have undergone web-based training in the principles of PC as pertained to ESLD.,"['Fourteen clinical centers will recruit 1260 patient-caregiver dyads', 'Patients with end-stage liver disease (ESLD', 'Eligible patients are those with new onset or ongoing complications of ESLD with a caregiver willing to participate', 'ESLD patients', 'patients with ESLD', 'End-Stage Liver Disease']","['PC intervention', 'specialist led consultative PC (Model 1) versus trained hepatologist led PC (Model 2']","['symptom burden, depression, distress, satisfaction with care, caregiver burden and QOL, goal concordant care, and health care utilization', ""patients' QOL"", 'QOL']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4280018', 'cui_str': 'Hepatologists'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.196674,Hepatologists at sites randomized to the Model 2 have undergone web-based training in the principles of PC as pertained to ESLD.,"[{'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Verma', 'Affiliation': 'Department of Digestive Diseases and Transplantation, Einstein Healthcare Network, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Kosinski', 'Affiliation': 'Department of Biostatistics, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Volk', 'Affiliation': 'Department of Gastroenterology and Hepatology, Loma Linda University, Loma Linda, California.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Taddei', 'Affiliation': 'Department of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Ramchandran', 'Affiliation': 'Division of Medical Oncology, Stanford University, Stanford, California.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'Center for Palliative and Support Care, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'Research Advisory Board, Einstein Healthcare Network, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Research Advisory Board, Einstein Healthcare Network, Philadelphia, Pennsylvania.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Navarro', 'Affiliation': 'Department of Digestive Diseases and Transplantation, Einstein Healthcare Network, Philadelphia, Pennsylvania.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0121']
1004,31486726,Development of an Outpatient Palliative Care Protocol to Monitor Fidelity in the Emergency Medicine Palliative Care Access Trial.,"Introduction:  Palliative care is recommended for patients with life-limiting illnesses; however, there are few standardized protocols for outpatient palliative care visits. To address the paucity of data, this article aims to: (1) describe the elements of outpatient palliative care that are generalizable across clinical sites; (2) achieve consensus about standardized instruments used to assess domains within outpatient palliative care; and (3) develop a protocol and intervention checklist for palliative care clinicians to document outpatient visit elements that might not normally be recorded in the electronic heath record.  Methods:  As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems. In addition, direct observation of outpatient palliative care visits, consultation from content experts, and survey data were used to develop an outpatient palliative care protocol and intervention checklist.  Implementation:  The protocol and checklist are being used to document the contents of each outpatient palliative care visit conducted as a part of the Emergency Medicine Palliative Care Access (EMPallA) trial. Variation across palliative care team staffing, clinic session capacity, and physical clinic model presents a challenge to standardizing the delivery of outpatient palliative care.",2019,"As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems.","['patients with life-limiting illnesses', 'outpatient care clinics across nine participating health care systems', 'older adults with serious life-limiting illnesses in the Emergency Department']","['nurse-led telephonic case management versus specialty, outpatient palliative care']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]",[],,0.0364681,"As part of a randomized control trial of nurse-led telephonic case management versus specialty, outpatient palliative care in older adults with serious life-limiting illnesses in the Emergency Department, we assessed the structural characteristics of outpatient care clinics across nine participating health care systems.","[{'ForeName': 'Corita R', 'Initials': 'CR', 'LastName': 'Grudzen', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Schmucker', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Shim', 'Affiliation': 'Augusta University Medical College of Georgia, Augusta, Georgia.'}, {'ForeName': 'Aminat', 'Initials': 'A', 'LastName': 'Ibikunle', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Chung', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Cohen', 'Affiliation': 'Department of Internal Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of palliative medicine,['10.1089/jpm.2019.0115']
1005,31486724,Protocol for a Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal).,"Introduction:  As health care systems strive to meet the growing needs of seriously ill patients with high symptom burden and functional limitations, they need evidence about how best to deliver home-based palliative care (HBPC). We compare a standard HBPC model that includes routine home visits by nurses and prescribing clinicians with a tech-supported model that aims to promote timely interprofessional team coordination using video consultation with the prescribing clinician while the nurse is in the patient's home. We hypothesize that tech-supported HBPC will be no worse compared with standard HBPC.  Methods:  This study is a pragmatic, cluster randomized noninferiority trial conducted across 14 Kaiser Permanente sites in Southern California and the Pacific Northwest. Registered nurses ( n  = 102) were randomized to the two models so that approximately half of the participating patient-caregiver dyads will be in each study arm. Adult English or Spanish-speaking patients (estimate 10,000) with any serious illness and a survival prognosis of 1-2 years and their caregivers (estimate 4800) are being recruited to the HomePal study over ∼2.5 years. The primary patient outcomes are symptom improvement at one month and days spent at home. The primary caregiver outcome is perception of preparedness for caregiving.  Study Implementation-Challenges and Contributions:  During implementation we had to balance the rigors of conducting a clinical trial with pragmatic realities to ensure responsiveness to culture, structures, workforce, workflows of existing programs across multiple sites, and emerging policy and regulatory changes. We built close partnerships with stakeholders across multiple representative groups to define the comparators, prioritize and refine measures and study conduct, and optimize rigor in our analytical approaches. We have also incorporated extensive fidelity monitoring, mixed-method implementation evaluations, and early planning for dissemination to anticipate and address challenges longitudinally. Trial Registration: ClinicalTrials.gov: NCT#03694431.",2019,Registered nurses ( n  = 102) were randomized to the two models so that approximately half of the participating patient-caregiver dyads will be in each study arm.,"['14 Kaiser Permanente sites in Southern California and the Pacific Northwest', 'Registered nurses ( n \u2009=\u2009102', 'Adult English or Spanish-speaking patients (estimate 10,000) with any serious illness and a survival prognosis of 1-2 years and their caregivers (estimate 4800) are being recruited to the HomePal study over ∼2.5 years']",['Home-Based Palliative Care (HomePal'],"['symptom improvement at one month and days spent at home', 'perception of preparedness for caregiving']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",,0.147029,Registered nurses ( n  = 102) were randomized to the two models so that approximately half of the participating patient-caregiver dyads will be in each study arm.,"[{'ForeName': 'Huong Q', 'Initials': 'HQ', 'LastName': 'Nguyen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Mularski', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Paula E', 'Initials': 'PE', 'LastName': 'Edwards', 'Affiliation': 'Hospice and Palliative Care Operations, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lynn', 'Affiliation': 'Program to Improve Elder Care, Altarum, Washington, DC.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Machado', 'Affiliation': 'Regional Home Care Operations, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'McBurnie', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Carmit', 'Initials': 'C', 'LastName': 'McMullen', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Reinke', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Shen', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Wang', 'Affiliation': 'West Los Angeles Medical Center, Kaiser Permanente Southern California, Pasadena, California.'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Werch', 'Affiliation': 'Stakeholder Advisory Committee Member, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of palliative medicine,['10.1089/jpm.2019.0116']
1006,32433779,Predictors of Systemic Exposure to Topical Crisaborole: A Nonlinear Regression Analysis.,"Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis. Results from 2 randomized, double-blind, vehicle-controlled phase 3 studies showed that twice-daily crisaborole in children and adults with mild to moderate atopic dermatitis was efficacious and well tolerated. Initial pharmacokinetics (PK) studies of crisaborole indicated absorption with measurable systemic levels of crisaborole. The current analysis was conducted to correlate steady-state systemic exposure parameters with ointment dose and identify covariates impacting PK parameters in healthy participants and patients with atopic dermatitis or psoriasis. A nonlinear regression analysis was conducted using ointment dose and noncompartmental PK parameters at steady state (area under the curve [AUC ss  ] and maximum concentration [C max,ss  ]). PK data were available from 244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241). Disease condition had the greatest impact on slope in both models, corresponding to 2.5-fold higher AUC ss  and C max,ss  values at a given ointment dose in patients with atopic dermatitis or psoriasis relative to healthy participants. Disease severity, race/ethnicity, and sex had marginal effects on AUC ss  and C max,ss  . Systemic exposures were similar across age groups ≥2 years of age when the same percentage of body surface area (%BSA) was treated. Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data. Model predictions indicated that systemic exposure to crisaborole in pediatric patients (2-17 years) is unlikely to exceed systemic exposure in adults (≥18 years), even at the highest possible ointment dose corresponding to a %BSA of 90.",2020,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","['children and adults with mild to moderate atopic dermatitis', 'healthy participants and patients with atopic dermatitis or psoriasis', 'pediatric patients (2-17\xa0years', '244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241', 'mild to moderate atopic dermatitis', 'patients with atopic dermatitis or psoriasis relative to healthy participants']","['Crisaborole ointment', 'Topical Crisaborole']","['efficacious and well tolerated', 'Systemic exposures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C4301784', 'cui_str': 'crisaborole Topical Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0366952,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1624']
1007,31483689,Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy.,"Chemotherapy-induced peripheral neuropathy (CIPN) causes significant pain and is an adverse effect of treatment with chemotherapeutic agents. We explored a somatic yoga and meditation intervention in a predominantly minority population. Goals included describing strategies for minority inclusion and testing feasibility and effectiveness. Eight individuals with CIPN enrolled in a single-arm feasibility trial. Somatic yoga and meditation were provided weekly for 8 weeks, with an additional home program component. The primary outcomes were Sit and Reach, Functional Reach, and Timed Up and Go. Secondary outcomes were Patient Neurotoxicity Questionnaire, FACT-GOG-Ntx (for addressing patient concerns associated with neurological symptoms), Brief Pain Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Falls Efficacy Scale. Sensitivity to vibration was measured via biothesiometer. Participants with a mean age of 65 (49-73) years self-reported as 63% African-American and 37% Caucasian. They attended 81% of the sessions, and no adverse events we re re p o rted. CIPN symptoms (FAC T- G O G - N t x ) improved significantly (from 88.88 to 106.88, standard deviation = 20.03; p = 0.039). Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081; p = 0.058). Other measures showed improvement trends, with a slight increase in Brief Pain Inventory pain severity (from 3.50 to 3.75, p = 0.041) possibly reflecting comorbidities. Four qualitative themes emerged: (1) CIPN symptom variability, with musculoskeletal comorbidities; (2) utility of learned skills; (3) improvement in self-confidence, balance, and stability; and (4) social support, with CIPN experience validation and increasing health literacy. Challenges of recruitment and retention require specific outreach, community trust, and health literacy. Preliminary data suggest that somatic yoga and meditation may affect fear of falling and quality of life in cancer survivors with CIPN. A randomized controlled trial using inclusive recruitment and retention methods is indicated to establish the intervention's efficacy.",2020,"Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081;  p  = 0.058).","['Participants with a mean age of 65 (49-73) years self-reported as 63% African-American and 37% Caucasian', 'predominantly minority population', 'Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy', 'cancer survivors with CIPN', 'Eight individuals with CIPN enrolled in a single-arm feasibility trial']","['somatic yoga and meditation', 'somatic yoga and meditation intervention', 'Somatic yoga and meditation', 'Somatic Yoga and Meditation']","['CIPN symptom variability, with musculoskeletal comorbidities; (2) utility of learned skills; (3) improvement in self-confidence, balance, and stability; and (4) social support, with CIPN experience validation and increasing health literacy', 'adverse events', 'Sit and Reach, Functional Reach, and Timed Up and Go', 'fear of falling and quality of life', 'Patient Neurotoxicity Questionnaire, FACT-GOG-Ntx (for addressing patient concerns associated with neurological symptoms), Brief Pain Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, and Falls Efficacy Scale', 'Brief Pain Inventory pain severity', 'CIPN symptoms (FACT-GOG-Ntx', 'Fear of falling', 'Sensitivity to vibration']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0150277'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0037438'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0522474', 'cui_str': 'Patient concerned (contextual qualifier) (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]",8.0,0.042035,"Fear of falling improved, approaching significance (from 39.26 to 34.38, standard deviation = 6.081;  p  = 0.058).","[{'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Galantino', 'Affiliation': 'Professor of Physical Therapy, Stockton University, Galloway, N.J.; University of Pennsylvania, Perelman School of Medicine, Philadelphia; and University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Oncology Rehabilitation and Lymphedema Management, Bacharach Institute for Rehabilitation, Pomona, N.J.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tiger', 'Affiliation': 'Yoga Heals 4 Life, Pomona, N.J.'}, {'ForeName': 'Shera', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Stockton University, Galloway, N.J.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Stockton University, Galloway, N.J.'}]",International journal of yoga therapy,['10.17761/2020-D-18-00030']
1008,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
1009,31474435,Effects of a Sexual HIV Risk Reduction Intervention for African American Mothers and Their Adolescent Sons: A Randomized Controlled Trial.,"PURPOSE


The aim of the article was to test the efficacy of an HIV risk reduction intervention for African American mothers in reducing condomless vaginal intercourse among mothers and their adolescent sons.
METHODS


In a randomized controlled trial design, mother-son dyads residing in public housing developments in Philadelphia, PA, were allocated to one of two four-session interventions: HIV risk reduction targeting sexual risk behaviors or attention-matched control targeting other health behaviors. Only mothers received the interventions; mothers and sons completed self-report measures preintervention, immediately postintervention, and 3, 6, 12, 18, and 24 months postintervention. The primary outcome was frequency of condomless vaginal intercourse in the past 3 months.
RESULTS


A total of 525 mother-son dyads participated, with 523 included in primary outcome analyses. Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment. The intervention's efficacy did not differ between mothers and sons or among the postintervention periods.
CONCLUSIONS


Mother-son interventions are an effective strategy to reduce sexual risks among African American mothers and their adolescent sons residing in public housing.",2019,"Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment.","['African American mothers in reducing condomless vaginal intercourse among mothers and their adolescent sons', 'mother-son dyads residing in public housing developments in Philadelphia, PA', 'A total of 525 mother-son dyads participated, with 523 included in primary outcome analyses', 'African American mothers and their adolescent sons residing in public housing', 'African American Mothers and Their Adolescent Sons']","['HIV risk reduction intervention', 'Sexual HIV Risk Reduction Intervention', 'HIV risk reduction targeting sexual risk behaviors or attention-matched control targeting other health behaviors']","['HIV risk reduction intervention', 'frequency of condomless vaginal intercourse in the past 3\xa0months', 'sexual risks']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C0034028', 'cui_str': 'Public Housing'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018687'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",525.0,0.0573804,"Generalized estimating equations analyses revealed that condomless sex was reduced in the HIV risk reduction intervention compared with the attention control group, adjusting for baseline self-reports and time of postintervention assessment.","[{'ForeName': 'Loretta Sweet', 'Initials': 'LS', 'LastName': 'Jemmott', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania. Electronic address: jemmott@drexel.edu.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Jemmott', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chittamuru', 'Affiliation': 'Public Health Department, School of Social Sciences, Humanities, and Arts, University of California, Merced, California.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Icard', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.05.017']
1010,30707651,Rubrum Coelis: The Contribution of Real-Time Telementoring in Acute Trauma Scenarios-A Randomized Controlled Trial.,"Background:  Most deaths in military trauma occur soon after wounding, and demand immediate on scene interventions. Although hemorrhage predominates as the cause of potentially preventable death, airway obstruction and tension pneumothorax are also frequent. First responders caring for casualties in operational settings often have limited clinical experience.   Introduction:  We hypothesized that communications technologies allowing for real-time communications with a senior medically experienced provider might assist in the efficacy of first responding to catastrophic trauma.   Methods:  Thirty-three basic life saving (BLS) medics were randomized into two groups: either receiving telementoring support (TMS, n = 17) or no telementoring support (NTMS, n = 16) during the diagnosis and resuscitation of a simulated critical battlefield casualty. In addition to basic life support, all medics were required to perform a procedure needle thoracentesis (not performed by BLS medics in Israel) for the first time. TMS was performed by physicians through an internet link. Performance was assessed during the simulation and later on review of videos.   Results:  The TMS group was significantly more successful in diagnosing (82.35% vs. 56.25%, p = 0.003) and treating pneumothorax (52.94% vs. 37.5%, p = 0.035). However, needle thoracentesis time was slightly longer for the TMS group versus the NTMS group (1:24  ±  1:00 vs. 0:49  ±  0:21 minu, respectively (p = 0.016). Complete treatment time was 12:56  ±  2:58 min for the TMS group, versus 9:33  ±  3:17 min for the NTMS group (p = 0.003).   Conclusions:  Remote telementoring of basic life support performed by military medics significantly improved the medics' ability to perform an unfamiliar lifesaving procedure at the cost of prolonging time needed to provide care. Future studies must refine the indications and contraindications for using telemedical support.",2019,"The TMS group was significantly more successful in diagnosing (82.35% vs. 56.25%, p = 0.003) and treating pneumothorax (52.94% vs. 37.5%, p = 0.035).",['Thirty-three basic life saving (BLS) medics'],"['receiving telementoring support (TMS, n\u2009=\u200917) or no telementoring support (NTMS, n\u2009=\u200916) during the diagnosis and resuscitation of a simulated critical battlefield casualty', 'NTMS', 'TMS']","['needle thoracentesis time', 'treating pneumothorax']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}]",,0.032614,"The TMS group was significantly more successful in diagnosing (82.35% vs. 56.25%, p = 0.003) and treating pneumothorax (52.94% vs. 37.5%, p = 0.035).","[{'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Netzer', 'Affiliation': 'Israel Defense Forces Medical Corps, Tel Hashomer, Israel.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Kirkpatrick', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Nissan', 'Affiliation': 'Israel Defense Forces Medical Corps, Tel Hashomer, Israel.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'McKee', 'Affiliation': 'Canadian Forces Medical Services, Ottawa, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McBeth', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Dobron', 'Affiliation': 'Israel Defense Forces Medical Corps, Tel Hashomer, Israel.'}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Glassberg', 'Affiliation': 'Israel Defense Forces Medical Corps, Tel Hashomer, Israel.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0173']
1011,26196502,Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.,"BACKGROUND


The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1).
METHODS


This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were coinfected with HIV-1. Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses. The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks.
RESULTS


Patients had HCV genotypes 1 through 4 (83% with genotype 1), and 14% had compensated cirrhosis; 98% were receiving antiretroviral therapy. Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients. Rates of sustained virologic response across all genotypes were 97.0% (95% CI, 91.6 to 99.4), 76.0% (95% CI, 61.8 to 86.9), and 98.1% (95% CI, 89.7 to 100), respectively. The most common adverse events were fatigue, nausea, and headache. There were no study-drug discontinuations because of adverse events. HIV-1 suppression was not compromised.
CONCLUSIONS


Among previously untreated HIV-HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection, the rate of sustained virologic response across all genotypes was 97.0% after 12 weeks of treatment and 76.0% after 8 weeks. (Funded by Bristol-Myers Squibb; ALLY-2 ClinicalTrials.gov number, NCT02032888.).",2015,"Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients.","['patients with HCV monoinfection', 'patients coinfected with human immunodeficiency virus type 1 (HIV-1', '151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were coinfected with HIV-1', 'Patients Coinfected with HIV-1']",['daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily'],"['HIV-1 suppression', 'efficacy and safety', 'rate of sustained virologic response', 'sustained virologic response', 'fatigue, nausea, and headache', 'Rates of sustained virologic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",151.0,0.210379,"Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients.","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wyles', 'Affiliation': ""From the University of California, San Diego, La Jolla (D.L.W.), Ruane Medical and Liver Health Institute (P.J.R.), the Jeffrey Goodman Clinic, Los Angeles LGBT Center (C.H.), and Southern California Men's Medical Group-Men's Health Foundation (A.M.), Los Angeles, the University of California, San Francisco, San Francisco (A.L.), Veterans Affairs Long Beach Healthcare System, Long Beach (T.R.M.), and Pacific Oaks Medical Group, Beverly Hills (A.S.) - all in California; Johns Hopkins University, Lutherville, MD (M.S.S.); Icahn School of Medicine at Mount Sinai, New York (D.D.); University of Cincinnati College of Medicine, Cincinnati (K.E.S.); Infectious Disease Specialists of Atlanta, Decatur, GA (R.D.); MedStar Washington Hospital Center (D.F.), Whitman-Walker Health (S.H.), and Capital Medical Associates (B.R.) - all in Washington, DC; the Cure C Consortium, Houston (J.C.G.), and Tarrant County Infectious Disease Associates, Fort Worth (C.M.) - both in Texas; Orlando Immunology Center, Orlando (F.H.), and Midway Immunology and Research Center, Fort Pierce (M.R.) - both in Florida; the University of Alabama at Birmingham, Birmingham (E.T.O.); the University of Colorado, Denver (G.R.); Lehigh Valley Health Network, Allentown, PA (J.Y.); and Bristol-Myers Squibb, Wallingford, CT (F.M., P.D.Y., P.A.), and Princeton, NJ (Z.L., E.H., S.N.).""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ruane', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Sulkowski', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dieterich', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': ''}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Dretler', 'Affiliation': ''}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Fishbein', 'Affiliation': ''}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Gathe', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Henn', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Hinestrosa', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Huynh', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Edgar Turner', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': ''}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Ramgopal', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rashbaum', 'Affiliation': ''}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Ray', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Scarsella', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yozviak', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McPhee', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Noviello', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ackerman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1503153']
1012,31732174,The effects of intensive dietary weight loss and exercise on gait in overweight and obese adults with knee osteoarthritis. The Intensive Diet and Exercise for Arthritis (IDEA) trial.,"The Intensive Diet and Exercise for Arthritis (IDEA) trial was an 18-month randomized controlled trial that enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA). Participants were randomized to either exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D + E) interventions. We previously reported that the clinical benefits of D + E were significantly greater than with either intervention alone (e.g., greater pain reduction, and better function, mobility, and health-related quality of life). We now test the hypothesis that D + E has greater overall benefit on gait mechanics compared to either intervention alone. Knee joint loading was analyzed using inverse dynamics and musculoskeletal modeling. Analysis of covariance determined the interventions' effects on gait. The D + E group walked significantly faster at 18-month follow-up (1.35 m s -1 ) than E (1.29 m s -1 , p = 0.0004) and D (1.31 m s -1 , p = 0.0007). Tibiofemoral compressive impulse was significantly lower (p = 0.0007) in D (1069 N s) and D + E (1054 N s) compared to E (1130 N s). D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss. Compared to E, D produces significant load reductions at the hip, knee, and ankle; combining D with E attenuates these reductions, but most remain significantly better than with E alone.",2020,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","['overweight and obese adults with knee osteoarthritis', 'enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA']","['intensive dietary weight loss and exercise', 'exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D\u202f+\u202fE) interventions']","['Peak ankle plantar flexion moment', 'Tibiofemoral compressive impulse', 'peak hip power production', 'hip abduction moment', 'peak hip external rotation moment', 'pain reduction, and better function, mobility, and health-related quality of life', 'Knee joint loading', 'resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces', 'weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0033268'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",454.0,0.0468876,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA; Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: messier@wfu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: dbeavers@wakehealth.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mihalko', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: mihalksl@wfu.edu.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: millergd@wfu.edu.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: mlyles@wakehealth.edu.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia; Rheumatology Department, Royal North Shore Hospital, Australia. Electronic address: david.hunter@sydney.edu.au.'}, {'ForeName': 'J Jeffery', 'Initials': 'JJ', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Vanderbilt School of Medicine, Nashville, TN, USA. Electronic address: j.jeffrey.carr@vanderbilt.edu.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Anatomy and Musculoskeletal Research, Paracelsus Medical University, Salzburg, Austria, & Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, MA, USA. Electronic address: guermazi@bu.edu.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Loeser', 'Affiliation': 'Thurston Arthritis Research Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: richard_loeser@med.unc.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DeVita', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC, USA. Electronic address: DEVITAP@ecu.edu.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109477']
1013,31195828,Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments: Reliability and Validity in Veterans Following Orthopedic Surgery.,"The patient-reported outcomes measurement information system (PROMIS) offers standardized assessment measures of clinically relevant patient-reported outcomes. This study evaluated the reliability and validity of select PROMIS measures with U.S. military veterans following orthopedic surgery. Data for the current study were collected as part of a pilot randomized control trial assessing the efficacy of a 1-day Acceptance and Commitment Therapy workshop on persistent postsurgical pain in at-risk veterans undergoing orthopedic surgery. Sixty-seven participants completed surveys 3 months after surgery. Participants completed the following PROMIS instruments: PROMIS Anxiety Short Form 8a, PROMIS Depression Short Form 8b, and PROMIS Pain Interference Short Form 8a. PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively. All three PROMIS measures demonstrated excellent internal consistency (Cronbach's αs ranged from .93 to .96) and each loaded onto a single factor. The PROMIS measures were moderately correlated with their respective comparison measures ( r  = .69 to .76). The PROMIS anxiety and PROMIS depression measures were highly correlated to one another ( r  = .91). Findings highlight the potential utility of these PROMIS measures in veterans following orthopedic surgery and the overlap between the PROMIS depression and anxiety measures in this sample.",2020,"PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively.","['Veterans Following Orthopedic Surgery', 'U.S. military veterans following orthopedic surgery', 'at-risk veterans undergoing orthopedic surgery']",['1-day Acceptance and Commitment Therapy workshop'],"['PROMIS anxiety and PROMIS depression measures', 'Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3874856', 'cui_str': 'Generalized anxiety disorder 7 item scale (assessment scale)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",67.0,0.0603727,"PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Lilian N', 'Initials': 'LN', 'LastName': 'Dindo', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'St Marie', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Roohina', 'Initials': 'R', 'LastName': 'Wajid', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Embree', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Nicolas O', 'Initials': 'NO', 'LastName': 'Noiseux', 'Affiliation': 'Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Tripp-Reimer', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, USA.'}]",Evaluation & the health professions,['10.1177/0163278719856406']
1014,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1']
1015,32439849,Effects of caffeine intake and exercise intensity on executive and arousal vigilance.,"During physical efforts and sport practice, vigilance is responsible for maintaining an optimal state of activation, guaranteeing the ability to quickly respond and detect unexpected, but critical, stimuli over time. Caffeine and physical exercise are able to modulate the activation state, affecting vigilance performance. The aim of the present work was to assess the specific effects and modulations of caffeine intake and two physical intensities on vigilance components. Participants performed an attentional task (ANTI-Vea) to measure the executive and arousal components of vigilance, in six double-blinded counterbalanced sessions combining caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise. Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates. Instead, caffeine intake generally improved arousal vigilance. In conclusion, caffeine and acute exercise seems to moderate executive and arousal vigilance in different ways.",2020,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.",[],"['Caffeine and physical exercise', 'caffeine', 'attentional task (ANTI-Vea', 'caffeine and acute exercise', 'caffeine intake and exercise intensity', 'caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise']","['arousal vigilance', 'moderate executive and arousal vigilance', 'executive and arousal vigilance', 'executive vigilance with faster overall reaction time (RT), without impairing error rates']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0355207,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain. carlos.sanchis@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain. jlupiane@ugr.es.'}]",Scientific reports,['10.1038/s41598-020-65197-5']
1016,31256137,Feasibility of Three Novel Forms of Passive Exercise in a Multisensory Environment in Vulnerable Institutionalized Older Adults with Dementia.,"BACKGROUND


Increasing physical activity levels in patients with dementia can reduce pathology severity and progression of the disease. However, physical activity programs can be challenging to adhere to for this vulnerable population. Three novel forms of passive exercise in a multisensory environment may be feasible alternatives for patients who can no longer be involved in physical activity.
OBJECTIVE


To determine the feasibility of three different forms of passive exercise in a multisensory environment in inactive institutionalized older adults with dementia.
METHODS


120 patients with dementia participated in this single blind randomized controlled trial (64.5% female, age 85.3±6.8 years Mini-Mental State Examination range 0-29). Ninety participants were randomly assigned to one of the three intervention groups: Therapeutic Motion Simulation (TMSim), Whole Body Vibration (WBV), and TMSim + WBV. Participants received 6 weeks of passive exercise, 4 sessions a week, 4 (WBV) to 12 (TMSim and TMSim + WBV) minutes per session. Feasibility of the novel forms of passive exercise was evaluated based on attendance, compliance, (proxy) experience scores, adverse events and drop-out rates.
RESULTS


On average 87.9% of the offered intervention sessions were attended. All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10). Intervention related drop-out rates were reasonable (12.2%) and no serious adverse events occurred.
CONCLUSION


The novel passive exercise interventions TMSim, WBV, and TMSim + WBV are feasible to apply in patients at all stages of dementia. More research is needed to establish effectiveness of passive exercise to limit adverse effects of dementia.",2019,All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10).,"['patients who can no longer be involved in physical activity', 'inactive institutionalized older adults with dementia', 'Ninety participants', 'patients at all stages of dementia', 'patients with dementia', '120 patients with dementia participated in this single blind randomized controlled trial (64.5% female, age 85.3±6.8 years Mini-Mental State Examination range 0-29', 'Vulnerable Institutionalized Older Adults with Dementia']","['passive exercise', 'Therapeutic Motion Simulation (TMSim), Whole Body Vibration (WBV), and TMSim\u200a+\u200aWBV', 'Passive Exercise', 'novel passive exercise interventions TMSim, WBV, and TMSim\u200a+\u200aWBV']","['serious adverse events', 'attendance, compliance, (proxy) experience scores, adverse events and drop-out rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0419121', 'cui_str': 'Passive exercise (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0044247', 'cui_str': 'TSIM'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",120.0,0.0285102,All three forms of passive exercise were well appreciated by the participants (7.3 on a scale from 0 to 10).,"[{'ForeName': 'Marelle', 'Initials': 'M', 'LastName': 'Heesterbeek', 'Affiliation': 'Molecular Neurobiology, Groningen Institute for Evolutionary Life Sciences (GELIFES), University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eddy Anton', 'Initials': 'EA', 'LastName': 'van der Zee', 'Affiliation': 'Molecular Neurobiology, Groningen Institute for Evolutionary Life Sciences (GELIFES), University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marieke Joan Gerda', 'Initials': 'MJG', 'LastName': 'van Heuvelen', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190309']
1017,31643039,"Pharmacodynamic assessment of prasugrel and clopidogrel in patients with non-cardioembolic stroke: a multicenter, randomized, active-control clinical trial.","Prasugrel, a novel P2Y 12  receptor antagonist, has been shown to be more effective than clopidogrel for preventing cardiovascular events in patients with acute coronary syndromes undergoing percutaneous coronary intervention. We investigated the dose-response antiplatelet effects of prasugrel compared with clopidogrel in Japanese patients with non-cardioembolic stroke. The influence of cytochrome P450 (CYP) polymorphisms on the antiplatelet effects of both drugs was also compared. In this multicenter randomized active-control comparative study, patients were randomized to receive prasugrel 2.5 mg, 5 mg, or 7.5 mg (double blind) or clopidogrel 75 mg (open label) once daily for 14 days. The primary endpoint was inhibition of platelet aggregation (IPA) in response to adenosine diphosphate 20 μM within 8 h of study drug administration on day 14. Of the 66 patients randomized, data from 63 (prasugrel 2.5 mg, 5 mg, and 7.5 mg groups, n = 14, 16, and 18, respectively; clopidogrel group, n = 15) were used in the pharmacodynamic assessment. IPA (arithmetic mean ± SD) after prasugrel administration increased dose-dependently (33 ± 9%, 44 ± 11%, and 53 ± 14%, at 2.5 mg, 5 mg, and 7.5 mg, respectively) and was higher in these groups than after clopidogrel (23 ± 16%). In a subgroup of CYP2C19 intermediate metabolizers, IPA was higher in the prasugrel 5 mg and 7.5 mg groups than in the clopidogrel group. No death or serious adverse events were reported. Prasugrel was well tolerated at doses up to 7.5 mg/day and had antiplatelet effects higher than those of clopidogrel 75 mg/day. CYP2C19 polymorphisms may have reduced clopidogrel-induced IPA.",2020,The primary endpoint was inhibition of platelet aggregation (IPA) in response to adenosine diphosphate 20 μM within 8 h of study drug administration on day 14.,"['patients with non-cardioembolic stroke', 'Japanese patients with non-cardioembolic stroke', 'patients with acute coronary syndromes undergoing percutaneous coronary intervention']","['clopidogrel', 'Prasugrel', 'prasugrel', 'prasugrel and clopidogrel', 'prasugrel 2.5\xa0mg, 5\xa0mg, or 7.5\xa0mg (double blind) or clopidogrel 75\xa0mg (open label']","['inhibition of platelet aggregation (IPA', 'IPA (arithmetic mean\u2009±\u2009SD', 'No death or serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0614109', 'cui_str': 'I(S)pA(S)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0441257,The primary endpoint was inhibition of platelet aggregation (IPA) in response to adenosine diphosphate 20 μM within 8 h of study drug administration on day 14.,"[{'ForeName': 'Takenori', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan. takeyama41119@ybb.ne.jp.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shirai', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yoshiba', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo Co., Ltd., 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 3-4-1 Okubo, Shinjuku-ku, Tokyo, 169-8555, Japan.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-019-01926-6']
1018,32439503,Pressure-Support Ventilation vs T-Piece During Spontaneous Breathing Trials Before Extubation Among Patients at High Risk of Extubation Failure: A Post-Hoc Analysis of a Clinical Trial.,"BACKGROUND


Spontaneous breathing trial (SBT) using a T-piece remains the most frequently performed trial before extubation in ICUs.
RESEARCH QUESTION


We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high risk of extubation failure.
STUDY DESIGN AND METHODS


Post hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72 hours after initial SBT, that is, extubated after initial SBT and not reintubated within the following 72 hours.
RESULTS


Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm H 2 O in median without positive end-expiratory pressure) in 243 patients (38%) and using a T-piece in 398 patients (62%). The proportion of patients successfully extubated 72 hours after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%; 95% CI, 2.8 to 28.1; P = .0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (P = .0002), whereas reintubation rates within the following 72 hours did not significantly differ (13% vs 10%, respectively; P = .4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted OR, 1.60; 95% CI, 1.30 to 2.18; P = .0061).
INTERPRETATION


In patients at high risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.",2020,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","['641 patients included in the original study, initial SBT', 'patients at high-risk of extubation failure']","['Pressure-support ventilation versus T-piece', 'SBT using pressure-support ventilation (PSV']","['successful extubation', 'successful extubation rates', 'proportion of patients extubated after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT, i.e. extubated after initial SBT', 'reintubation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}]",641.0,0.20449,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061).
","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France. Electronic address: aw.thille@gmail.com.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), UMRS1158 neurophysiologie respiratoire expérimentale et clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Levrat', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, Université Paris Diderot, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, Université de Tours, Tours, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Massri', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.04.053']
1019,32439926,Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial.,"The visceral analgesic efficacy of erector spinae plane block (ESPB) is still a matter of debate. This study attempted to investigate the visceral analgesic efficacy of ESPB in clinical setting. After randomized, we performed ultrasound-guided bilateral rectus sheath block (RSB), which was aimed to prevent postoperative somatic pain on all patients who underwent laparoscopic cholecystectomy (LC). Ultrasound-guided bilateral ESPB at T7 level was performed only to the intervention group to provide the visceral analgesic block. The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group. The ESPB group consistently showed lower accumulated analgesic consumption compared with those in the non-ESPB group at all observed time-points (all P < 0.05) after 2 hours and the degree of the accumulated analgesic consumption reduction was greater (P = 0.04) during the 24-hour postoperative period. Pain severity was lower in the ESPB group at 6-hours postoperatively. The significantly reduced opioid consumption in ESPB group may imply that while preliminary and in need of confirmation, ESPB has potential visceral analgesic effect. Therefore, performing ESPB solely may be feasible in inducing both somatic and visceral analgesia.",2020,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.",[],"['ESPB', 'remifentanil', 'erector spinae plane block (ESPB', 'laparoscopic cholecystectomy (LC', 'ultrasound-guided bilateral rectus sheath block (RSB']","['visceral analgesic efficacy', 'analgesic consumption', 'intraoperative requirement', 'Pain severity', 'cumulative fentanyl consumption', 'analgesic consumption reduction', 'opioid consumption']",[],"[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.05068,"The intraoperative requirement for remifentanil (P = 0.021) and the cumulative fentanyl consumption at postoperative 24-hours was significantly lower in the ESPB group (206.5 ± 82.8 μg vs.283.7 ± 102.4 μg, respectively; P = 0.004) compared to non-ESPB group.","[{'ForeName': 'Hye-Mee', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sung-Moon', 'Initials': 'SM', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Kyu Taek', 'Initials': 'KT', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Sooin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea.'}, {'ForeName': 'Jong-Hyuk', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, 05505, Korea. leejhpain@amc.seoul.kr.'}]",Scientific reports,['10.1038/s41598-020-65172-0']
1020,31536007,The Reorganization of Resting-State Brain Networks Associated With Motor Imagery Training in Chronic Stroke Patients.,"A number of studies have suggested that motor imagery training (MIT) has a positive influence on the upper extremity motor recovery in stroke patients, but little is known about its neural basis. To investigate the cortical motor network plasticity after MIT, 34 chronic hemiplegic subjects with subcortical stroke were recruited and randomly allocated to either the conventional rehabilitation therapy (CRT) or the CRT + MIT. The patients were assessed with the upper limb section of Fugl-Meyer assessment Scale (FM-UL) and resting-state fMRI before and after the 4 weeks of treatment. Seed-based functional connectivity (FC) of the ipsilesional primary motor cortex (M1) and graph-theory based analysis were used to explore the relationships between the motor recovery and reorganization of motor networks. We found that the patients in the MIT group showed more improvement in the FM-UL scores compared with the CRT group. Both groups presented increased inter-hemispheric and decreased intra-hemispheric FC of the ipsilesional M1 after intervention. However, the MIT group showed increased FC of the ipsilesional M1 with the ipsilesional precentral and postcentral gyri, middle cingulate gyrus and supramarginal gyrus after intervention, while the CRT group showed decreased FC in these regions. In addition, the clustering coefficient was significantly increased in the MIT group but not in the CRT group, and the increment of clustering coefficient was significantly positively correlated with improvement of FM-UL scores. Therefore, MIT might contribute to the motor recovery in stroke patients through the following network reorganization, i.e., promoting the efficiency of regional neuronal communication and the reorganization of intrinsic FC of the ipsilesional M1 involving widely distributed motor network in both hemispheres.",2019,We found that the patients in the MIT group showed more improvement in the FM-UL scores compared with the CRT group.,"['chronic stroke patients', '34 chronic hemiplegic subjects with subcortical stroke', 'stroke patients']","['conventional rehabilitation therapy (CRT) or the CRT+MIT', 'motor imagery training', 'motor imagery training (MIT', 'MIT']","['FC of the ipsilesional M1 with the ipsilesional precentral and postcentral gyri, middle cingulate gyrus and supramarginal gyrus', 'inter-hemispheric and decreased intra-hemispheric FC', 'FM-UL scores', 'FC', 'clustering coefficient', 'upper limb section of Fugl-Meyer assessment Scale (FM-UL) and resting-state fMRI']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0152302', 'cui_str': 'Gyrus Postcentralis'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0228214', 'cui_str': 'Supramarginal Gyrus'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",34.0,0.0230309,We found that the patients in the MIT group showed more improvement in the FM-UL scores compared with the CRT group.,"[{'ForeName': 'Hewei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Changhui', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2940980']
1021,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z']
1022,31463529,Patient navigation for overactive bladder improves access to care.,"INTRODUCTION AND HYPOTHESIS


Patients with overactive bladder (OAB) become discouraged with medication therapy because of the side effects, minimal subjective improvement and costs of therapy. With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
METHODS


This was a quality improvement study carried out over a 17-month period comparing utilization of a navigation pathway versus patients without navigation. The data were obtained using an online database (PPS Analytics) to compare medication use, cystoscopy, urodynamic studies, use of third-line therapy, and return visits.
RESULTS


A total of 535 patients were included in the analysis and broken down into two respective groups. Group 1 were those placed on the navigation pathway and able to be reached via telephone (n = 431). Group 2 were those started on the navigation pathway who were not able to be reached via telephone, but were chart reviewed by a navigator (n = 104). Third-line therapy usage for groups 1 and 2 was 24% and 11% respectively. Return visits for additional OAB management for groups 1 and 2 were found to be 71% and 50% respectively.
CONCLUSION


Patient retention levels and utilization of third-line therapies are significantly improved when utilizing a navigation pathway. With 24% of the patients included in this study opting for third-line therapy, this represents a 600% increase in third-line therapies over national averages.",2020,"With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
","['A total of 535 patients were included in the analysis and broken down into two respective groups', 'Patients with overactive bladder (OAB']",['navigation pathway versus patients without navigation'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443161', 'cui_str': 'Breaking down (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],535.0,0.0178035,"With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rohloff', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA. Matthew.Rohloff@metrogr.org.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Peifer', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA.'}, {'ForeName': 'Jannah H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04085-7']
1023,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
1024,31789554,Female drinkers are more sensitive than male drinkers to alcohol-induced heart rate increase.,"The present study examined the acute effect of alcohol and its cues on autonomic and cardiovascular physiology, as indexed by changes in heart rate (HR), in a relatively large sample of healthy young adult men and women. Participants (27-31 years old, final  N  = 145) were administered an alcoholic beverage ( n  = 88; 52 women) or a placebo beverage ( n  = 57; 35 women) in a simulated bar. Target breath alcohol concentration (BrAC) was .08 g%. HR was recorded while participants were seated alone during an initial baseline assessment in a lab room; seated with others during preparation and administration of 2 beverages in a simulated bar; and seated alone in the lab room at ascending, peak, and descending BrAC. HR increased over time for participants in both beverage groups during beverage preparation. During beverage consumption, HR decreased over time in those who drank placebo whereas HR increased over time in those who drank alcohol, increasing at a faster rate in women compared to men. HR remained elevated at the ascending, peak, and descending limb assessments only in participants who drank alcohol with HR increasing over time at ascending BrAC in the women but not men. Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation. Our findings suggest that women may be more sensitive to alcohol-induced increases in HR, especially in environments where alcohol cues are abundant. This may have implications for cardiovascular risks associated with alcohol. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","['Participants (27-31 years old, final  N  = 145', 'healthy young adult men and women', 'Female drinkers']","['placebo', 'placebo beverage', 'alcoholic beverage']","['HR', 'Target breath alcohol concentration (BrAC', 'heart rate (HR']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic Beverages'}]","[{'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",2019.0,0.0349077,"Sex differences in HR under alcohol were not explained by sex differences in body mass index, BrAC, recent alcohol use, or subjective stimulation.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, The University of Missouri.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fromme', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000338']
1025,30882166,Effect of Irrigation Solution Temperature on Complication of Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE


Many factors affecthypothermia and shivering during percutaneous nephrolithotomy and in recovery.Hence this study was carried out to determine the effect of irrigation solution temperature on complications ofpercutaneous nephrolithotomy.
MATERIALS AND METHODS


In this randomized clinical trial, 60 patients undergoing PCNL in Sina University Hospitalwere enrolled. The patients were randomly assigned in three groups according to simple random manner. Thegroups included three groups of room temperature fluid (24 degree), warm solution (37 degree), and cold fluid (20degree) during nephroscopy.
RESULTS


Although the initial core temperature was alike across the groups (P > .05); the hypothermia rate occuredin all 20 patients in the cold fluid group (P = .012). There was significant difference between the groups interms of final temperature and alteration amount (P = .001). The mean VAS scores were significantly lower in thewarm fluid group compared with the others groups at recovery, and 8hrs post-operatively (P = .03). Assessmentof shivering rates revealed that 3(15%) patients in warm solution group shivered compared to8 (40%) patients incold fluid group (P = .018).
CONCLUSION


Warm irrigation solution during PCNL results in significantly decreased hypothermia, mean postoperativepain score and shivering. Hence use of warm irrigation fluid for this matter is recommended.",2019,"The mean VAS scores were significantly lower in warm fluid group compared with the others groups at the recovery, and 8 h postoperatively (P = 0.03).",['60 patients under PCNL in Sina University Hospital were enrolled'],"['percutaneous nephrolithotomy', 'irrigation solution temperature', 'Irrigation Solution Temperature']","['hypothermia rate', 'shivering rates', 'mean VAS scores', 'hypothermia, the mean postoperative pain score and shivering', 'Complication of Percutaneous Nephrolithotomy', 'final temperature and alteration amount']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C2746010', 'cui_str': 'Irrigating solution'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",60.0,0.0647947,"The mean VAS scores were significantly lower in warm fluid group compared with the others groups at the recovery, and 8 h postoperatively (P = 0.03).","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Hosseini', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences ,Tehran, Iran. rhosseinim@yahoo.com.'}, {'ForeName': 'Mohammad Ghasem', 'Initials': 'MG', 'LastName': 'Mohseni', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences ,Tehran, Iran. Email: mgmohseni@tums.ac.ir.'}, {'ForeName': 'Seyed Mohammad Kazem', 'Initials': 'SMK', 'LastName': 'Aghamir', 'Affiliation': 'Department of Urology, Tehran University of Medical Sciences, Tehran, Iran. Email: smkaghamir@yahoo.com.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rezaei', 'Affiliation': 'Resident of Urology, Tehran University of Medical Sciences ,Tehran, Iran. hamed109@gmail.com.'}]",Urology journal,['10.22037/uj.v0i0.4399']
1026,31920016,Clinical Role of the Chronic Obstructive Pulmonary Disease Assessment Test in Prediction of the Response to Treatment for Exacerbations.,"BACKGROUND


The chronic obstructive pulmonary disease (COPD) assessment test (CAT) is a validated, eight-item questionnaire used to quantify the health status of patients. The aim of this study was to evaluate the usefulness of the CAT questionnaire as a tool to assess the response to treatment in acute exacerbations of COPD in an outpatient setting.
METHODS


A multicenter, phase 3 randomized controlled trial was conducted previously to examine the efficacy and safety of oral zabofloxacin for the treatment of COPD exacerbations. In the present post hoc analysis of the original study, patients with COPD exacerbation were categorized as responders or non-responders according to the respiratory symptoms persisting on day 10 (visit 3) of treatment. The CAT questionnaire was completed daily by patients at home from the initial visit to the second visit on day 5. Subsequently, the questionnaire was completed in the presence of a physician on days 10 (visit 3) and 36 (visit 4). Multivariate regression analysis was performed to determine the association between CAT scores and the therapeutic response.
RESULTS


The CAT scores decreased more rapidly in responders compared to non-responders during the first 5 days (23.3-20.4 vs. 23.5-22). Among responders, patients with higher severity of illness also revealed higher CAT scores on the first day of an exacerbation (mild, 19.8; moderate, 21.4; severe, 23.8; very severe, 28.6). Multivariate analysis revealed that a change in the CAT score during the first 3 days influenced the therapeutic response. A significant decrease in scores in the domains of sputum production, chest tightness, and activities of daily living was seen among responders.
CONCLUSION


Early improvement in CAT scores may be associated with a more favorable response to the treatment of COPD exacerbations.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01658020.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0000532.",2020,"A significant decrease in scores in the domains of sputum production, chest tightness, and activities of daily living was seen among responders.
","['acute exacerbations of COPD in an outpatient setting', 'COPD exacerbations']","['CAT questionnaire', 'oral zabofloxacin']","['efficacy and safety', 'therapeutic response', 'sputum production, chest tightness, and activities of daily living', 'CAT score', 'CAT scores', 'CAT scores and the therapeutic response']","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2826065', 'cui_str': 'zabofloxacin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0033268'}, {'cui': 'C0232292', 'cui_str': 'Tight chest (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.102382,"A significant decrease in scores in the domains of sputum production, chest tightness, and activities of daily living was seen among responders.
","[{'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Tae Eun', 'Initials': 'TE', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Hyung', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonology, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Ju Ok', 'Initials': 'JO', 'LastName': 'Na', 'Affiliation': 'Division of Allergy and Respiratory Disease, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.'}, {'ForeName': 'Kyeong Cheol', 'Initials': 'KC', 'LastName': 'Shin', 'Affiliation': 'Regional Center for Respiratory Disease, Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Chin Kook', 'Initials': 'CK', 'LastName': 'Rhee', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Jung', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Kang Hyeon', 'Initials': 'KH', 'LastName': 'Choe', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Kwang Ha', 'Initials': 'KH', 'LastName': 'Yoo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea. khyou@kuh.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e10']
1027,31464532,Pulmonary Vascular Pressure Response to Acute Cold Exposure in Kyrgyz Highlanders.,"Background/Aims:  Long-term high altitude residence leads to a sustained increase in pulmonary vascular resistance and elevation of pulmonary artery pressure due to chronic alveolar hypoxia. However, living at high altitude is also associated with other environmental factors such as cold. There is still little experimental evidence suggesting detrimental effects of low temperatures on the pulmonary vasculature. Therefore, our objective was to investigate acute effects of cold exposure on the pulmonary circulation in Kyrgyz high altitude natives.  Methods:  Responses of the pulmonary circulation during acute exposure to controlled cold conditions (4°C-6°C) for 60 minutes were measured in highlanders using Doppler echocardiography. Based on the Doppler echocardiography-derived tricuspid regurgitant systolic pressure gradient (TRG), subjects with TRG ≥40 mmHg were allocated into the pulmonary hypertension (PH) group. Participants from the PH group were compared with volunteer control subjects with TRG <40 mmHg. All baseline measurements were evaluated in a warm room during 60 minutes (22°C-28°C). Following baseline echocardiography, the subjects were assigned to either warm or cold exposure for an additional 60 minutes.  Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg). No changes in cardiac output were observed upon cold exposure.  Conclusion:  Thus, acute exposure to cold leads to elevation of pulmonary artery pressure in high altitude residents.",2019,"Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg).","['Kyrgyz Highlanders', 'kyrgyz highlanders', 'subjects with TRG ≥40\u2009mmHg were allocated into the pulmonary hypertension (PH) group', 'Kyrgyz high altitude natives']","['High Alt Med Biol', 'Doppler echocardiography-derived tricuspid regurgitant systolic pressure gradient (TRG']","['Sydykov, Akylbek, Abdirashit Maripov, Kubatbek Muratali Uulu, Nadira Kushubakova, Aleksandar Petrovic, Christina Vroom, Meerim Cholponbaeva, Melis Duishobaev, Samatbek Satybaldyev, Nurgul Satieva, Argen Mamazhakypov, Meerim Sartmyrzaeva, Nazgul Omurzakova, Zhainagul Kerimbekova, Nursultan Baktybek, Oleg Pak, Lan Zhao, Norbert Weissmann, Akpay Sarybaev, Sergey Avdeev, Hossein Ardeschir Ghofrani, Ralph Theo Schermuly, and Djuro Kosanovic', 'Pulmonary vascular pressure response', 'cardiac output', 'pulmonary vascular resistance and elevation of pulmonary artery pressure', 'TRG']","[{'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013520', 'cui_str': 'Echocardiography, Doppler'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]","[{'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}]",,0.0376725,"Results:  Acute cold exposure significantly increased TRG both in the control (ΔTRG, 4.93 mmHg) and in the PH (ΔTRG, 8.15 mmHg) group, compared to the respective warm exposure conditions (ΔTRG, -0.14 and -0.05 mmHg).","[{'ForeName': 'Akylbek', 'Initials': 'A', 'LastName': 'Sydykov', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Abdirashit', 'Initials': 'A', 'LastName': 'Maripov', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Kubatbek', 'Initials': 'K', 'LastName': 'Muratali Uulu', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Kushubakova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Petrovic', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vroom', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Meerim', 'Initials': 'M', 'LastName': 'Cholponbaeva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Duishobaev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Samatbek', 'Initials': 'S', 'LastName': 'Satybaldyev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nurgul', 'Initials': 'N', 'LastName': 'Satieva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Argen', 'Initials': 'A', 'LastName': 'Mamazhakypov', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Meerim', 'Initials': 'M', 'LastName': 'Sartmyrzaeva', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nazgul', 'Initials': 'N', 'LastName': 'Omurzakova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Zhainagul', 'Initials': 'Z', 'LastName': 'Kerimbekova', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nursultan', 'Initials': 'N', 'LastName': 'Baktybek', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Pak', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Weissmann', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Akpay', 'Initials': 'A', 'LastName': 'Sarybaev', 'Affiliation': 'Department of Mountain and Sleep Medicine and Pulmonary Hypertension, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Avdeev', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Hossein Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Ralph Theo', 'Initials': 'RT', 'LastName': 'Schermuly', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Djuro', 'Initials': 'D', 'LastName': 'Kosanovic', 'Affiliation': 'Department of Internal Medicine, Excellence Cluster Cardio-Pulmonary System (ECCPS), Member of the German Center for Lung Research (DZL), Justus Liebig University of Giessen, Giessen, Germany.'}]",High altitude medicine & biology,['10.1089/ham.2019.0046']
1028,32140973,"Sense of coherence and its relationship to participation, cancer-related fatigue, symptom burden, and quality of life in women with breast cancer participating in the OptiTrain exercise trial.","PURPOSE


This study examined the Sense of Coherence (SOC) of patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain) study and assessed how patient characteristics were associated with SOC. Secondary aims were to assess the association between SOC and patients' participation in this study and to determine whether SOC moderates the effect of the 16-week exercise intervention on fatigue, quality of life (QoL), and symptom burden in women with breast cancer undergoing chemotherapy.
METHODS


Modified Poisson regression analyses were conducted to determine the relative risk of weak-normal SOC versus strong SOC in terms of exercise session attendance, study and intervention dropout, and long absence rates. Analyses of covariance were performed to assess whether SOC moderated the effect of the exercise intervention (p interaction  ≤ 0.10).
RESULTS


Two hundred and forty women with early breast cancer (mean age 53 ± 10) participated in the OptiTrain study. Women with strong SOC reported less fatigue, lower symptom burden, and higher QoL. Women with weak-normal SOC were significantly more likely to drop out from the OptiTrain study and tended to have slightly poorer exercise session attendance. Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
CONCLUSIONS


Strong SOC appears to be associated with a more positive subjective state of health. Women with weak-normal SOC may need additional support to encourage participation and adherence in exercise trials. Assessing SOC may assist clinicians to identify and provide extra support for participants with weak SOC, who may be less inclined to participate in exercise programs.",2020,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","['women with breast cancer undergoing chemotherapy', 'Women with weak-normal SOC', 'Women with breast cancer and weaker SOC', 'women with breast cancer participating in the OptiTrain exercise trial', 'Two hundred and forty women with early breast cancer (mean age 53\u2009±\u200910) participated in the OptiTrain study', ""patients participating in the randomized controlled 'Optimal Training for Women with Breast Cancer' (OptiTrain"", 'participants with weak SOC']",['exercise intervention'],"['participation, cancer-related fatigue, symptom burden, and quality of life', 'fatigue, quality of life (QoL), and symptom burden']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",240.0,0.059464,"Women with breast cancer and weaker SOC benefitted as much from the exercise intervention, in terms of fatigue and QoL, as those with stronger SOC (p interaction  > 0.10).
","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. a.e.hiensch-2@umcutrecht.nl.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05378-0']
1029,32441031,Electrocautery Needling and the 308-nm Excimer Lamp: A Synergistic Combination for the Treatment of Stable Non-segmental Vitiligo.,"INTRODUCTION


Vitiligo is an acquired chronic depigmentation disorder caused by the destruction of melanocytes. Although various treatments have been proposed for the management of vitiligo, achieving repigmentation and preventing relapse remains challenging. The aim of the study was to evaluate the effectiveness of electrocautery needling (EC needling) as a treatment for stable non-segmental vitiligo and to determine if the effectiveness of this treatment could be enhanced by combining it with the 308-nm excimer lamp (excimer lamp).
METHODS


Thirty patients with stable non-segmental vitiligo were enrolled in this self-controlled, non-blinded study. Three vitiligo lesions of similar size, location and disease duration were selected from each patient and randomly assigned to one of three groups treated weekly with EC needling, an excimer lamp or a combination of both (combination group), respectively. The effectiveness of treatment on the repigmentation percentage and the number of treatments required for initial pigmentation were assessed.
RESULTS


There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789). The mean number of treatments required for initial repigmentation was lower in the EC needling group than in the excimer lamp group (P = 0.049). The repigmentation percentage was significantly higher in the combination group than in the EC needling group (P = 0.027) and excimer lamp group (P = 0.005). Evidence of initial pigmentation was obtained earlier in lesions treated with the combination therapy than in lesions treated with excimer lamp therapy alone (P = 0.019). Vitiligo lesions on the face and neck regions showed the highest repigmentation percentage among all anatomical regions, whereas lesions on the hands and feet showed the worst treatment response.
CONCLUSION


Electrocautery needling monotherapy was effective in treating vitiligo, and its efficacy was enhanced when combined with the 308-nm excimer lamp. This combined approach to treat vitiligo is safe and helps increase patient compliance.",2020,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"['Thirty patients with stable non-segmental vitiligo', 'Stable Non-segmental Vitiligo', 'stable non-segmental vitiligo']","['excimer lamp therapy', 'Electrocautery needling monotherapy', 'Electrocautery Needling and the 308-nm Excimer Lamp', 'excimer lamp', '308-nm excimer lamp (excimer lamp', 'electrocautery needling (EC needling', 'EC needling, an excimer lamp or a combination of both (combination group']","['repigmentation percentage', 'Vitiligo lesions', 'mean number of treatments required for initial repigmentation', 'initial pigmentation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332121', 'cui_str': 'Treatment required for'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",30.0,0.0265379,There was no significant difference in the repigmentation percentage between the EC needling group and the excimer lamp group (P = 0.789).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Pui Mun', 'Initials': 'PM', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Katayama', 'Affiliation': 'Department of Pigmentation Research and Therapeutics, Graduate School of Medicine, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of TCM Chemistry, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China. zhanghm@shutcm.edu.cn.'}]",Dermatology and therapy,['10.1007/s13555-020-00395-7']
1030,32437690,Effect of Anodal Transcranial Direct Current Stimulation at the Right Dorsolateral Prefrontal Cortex on the Cognitive Function in Patients With Mild Cognitive Impairment: A Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To study the effect of anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC) on cognitive function and side effects in patients with mild cognitive impairment.
DESIGN


Experimental double-blind randomized, sham-controlled trial.
SETTING


Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital PARTICIPANTS: Volunteers (N=45) with mild cognitive impairment.
INTERVENTIONS


Not applicable.
MAIN OUTCOME MEASURES


The atDCS group (n=23) were stimulated at 2 mA for 20 minutes with the anode on the right DLPFC and the cathode on the left supraorbital area. The control group (n=22) received placebo stimulation. Baseline cognitive function was assessed using the Cambridge Neuropsychological Test Automated Battery test. Participants were treated 3 times per week for 4 weeks (12 sessions). Cognitive function and side effects were assessed immediately after the first stimulation, the last session, and 4 weeks after treatment.
RESULTS


Cambridge Neuropsychological Test Automated Battery results revealed a significant improvement in the accuracy of the visual sustained attention (VSA) in the atDCS group at all 3 time points, the spatial working memory and visual memory (VM) immediately after the first stimulation, and a decreased VM reaction time after 12 sessions. A long-lasting effect on VSA and VM were found 4 weeks after treatment.
CONCLUSIONS


Anodal tDCS over the right DLPFC enhanced the VSA, spatial working memory, and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions. A long-lasting effect on VSA and VM was found 4 weeks after treatment. This study corroborated atDCS as a safe technique to improve cognitive function.",2020,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[' Participants (45) who met the inclusion criteria', 'patients with mild cognitive impairment', 'Department of Rehabilitation Medicine, Tertiary Hospital SUBJECTS', 'patients with mild cognitive impairment (MCI']","['anodal transcranial direct current stimulation', 'anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC', 'placebo stimulation']","['Baseline cognitive function', 'reaction time of VM', 'VSA, SWM and VM accuracy', 'spatial working memory (SWM) and visual memory (VM', 'Cognitive function and side effects', 'VM reaction time', 'cognitive function', 'accuracy of the visual sustained attention (VSA', 'VSA and VM', 'Cambridge Neuropsychological Test Automated Battery (CANTAB) test', 'cognitive function and side effects']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",45.0,0.0855784,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[{'ForeName': 'Chernkhuan', 'Initials': 'C', 'LastName': 'Stonsaovapak', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Solaphat', 'Initials': 'S', 'LastName': 'Hemrungroj', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Terachinda', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Krisna', 'Initials': 'K', 'LastName': 'Piravej', 'Affiliation': 'Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Krisna.P@chula.ac.th.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.023']
1031,8397213,Migration of hydroxyapatite coated femoral prostheses. A Roentgen Stereophotogrammetric study.,"We allocated randomly 27 patients undergoing 28 primary uncemented total hip replacements (THR) to receive prosthetic components of similar design with either plasma-sprayed titanium alloy (Ti) coating (n = 13) or hydroxyapatite (HA) coating (n = 15). After some exclusions, 15 of the patients (15 THR; 7 with HA- and 8 with Ti-coating) were followed by roentgen stereophotogrammetric analysis at 3, 6 and 12 months to measure migration of the femoral component. Twenty-six of the patients (26 THR) were followed clinically and by conventional radiography. All the femoral components had migrated at 3 months. From 3 to 12 months, the migration of Ti-coated components continued whereas the HA-coated components had stabilised. At 12 months there was significantly less migration of the HA-coated components (p < 0.05). The maximum subsidence was 0.2 mm in both groups. The Harris hip score was equal in the two groups preoperatively but at follow-up it was better in the HA-coated group (p < 0.05) and visual analogue scale scores showed that they had less pain (p < 0.05).",1993,The Harris hip score was equal in the two groups preoperatively but at follow-up it was better in the HA-coated group (p < 0.05) and visual analogue scale scores showed that they had less pain (p < 0.05).,['27 patients undergoing 28 primary'],"['uncemented total hip replacements (THR) to receive prosthetic components of similar design with either plasma-sprayed titanium alloy (Ti) coating (n = 13) or hydroxyapatite (HA) coating', 'hydroxyapatite coated femoral prostheses']","['pain', 'migration of Ti-coated components', 'migration of the HA-coated components', 'Harris hip score', 'visual analogue scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0290219', 'cui_str': 'titanium-13-niobium-13-zirconium'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",27.0,0.0246857,The Harris hip score was equal in the two groups preoperatively but at follow-up it was better in the HA-coated group (p < 0.05) and visual analogue scale scores showed that they had less pain (p < 0.05).,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus Kommunehospital, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Toksvig-Larsen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gelineck', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fruensgaard', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ryd', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lucht', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bünger', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1032,31184382,"Impact of a behavioral intervention, delivered by pediatricians or psychologists, on sleep problems in children with ADHD: a cluster-randomized, translational trial.","BACKGROUND


We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost-effective when delivered by pediatricians or psychologists in community settings.
METHODS


Translational, cluster-randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5-13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep-wake phase disorder, or were experiencing sleep-related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies.
RESULTS


In an intention-to-treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost-effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months.
CONCLUSIONS


A low-cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial.",2019,"6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001).","['Participants (n\xa0=\xa0361) were children aged 5-13\xa0years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep-wake phase disorder, or were experiencing sleep-related anxiety', 'from 19th January, 2015 to 30th June, 2017', 'children with ADHD']","['behavioral intervention', 'usual care', 'behavioral intervention, delivered by pediatricians or psychologists', 'consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies', 'behavioral intervention versus usual care', 'behavioral sleep intervention']","['proportion of children with moderate to severe sleep problems', ""multiple Children's Sleep Habits Questionnaire subscales"", 'Cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C4304028', 'cui_str': 'Sleep medicine'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",361.0,0.0905631,"6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001).","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Centre for Community Child Health, The Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Health Services, Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Heussler', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rinehart', 'Affiliation': 'Deakin Child Study Centre, School of Psychology, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Schuster', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit and Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, VIC, Australia.""}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Grobler', 'Affiliation': 'Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Shalika', 'Initials': 'S', 'LastName': 'Bohingamu Mudiyanselage', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hayes', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': ""Centre for Community Child Health, The Royal Children's Hospital, Parkville, VIC, Australia.""}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13083']
1033,32440977,Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis.,"PURPOSE


To evaluate, by laser photometry, the persistency of anterior chamber flare after uneventful phacoemulsification in asymptomatic patients with no signs of inflammation on slit lamp examination.
METHOD


Seventy-five patients previously enrolled in a randomized clinical trial that evaluated inflammation after uneventful phacoemulsification in eyes treated with dexamethasone 0.1% ophthalmic suspension (group 1) or bromfenac 0.09% ophthalmic solution (group 2) for 2 weeks. Anterior chamber inflammation was investigated by laser flare photometry. At 30 days after surgery, laser flare showed persistently elevated values. For this reason, patients were further analyzed at 3 and 6 months. Additionally, optical coherence tomography was used to measure the central macular thickness (CMT) and to assess for postoperative pseudophakic macular edema.
RESULTS


When compared to preoperative values, laser flare photometry demonstrated persistent ocular inflammation at postoperative days 90 and 180 in group 1, but not in group 2. Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001). The increase in mean CMT at days 90 and 180 with respect to baseline was statistically significant in group 1 but not in group 2, in which it decreased to levels similar to preoperative value. Group 1 showed a higher increase in mean CMT compared to group 2 throughout all the follow-up (p < 0.001). The proportion of patients that developed pseudophakic cystoid macular edema (CME) was 14% (n = 5) and 0% (n = 0) in group 1 and group 2, respectively (p = 0.02). The bivariate analysis demonstrated a positive correlation between laser flare and CMT values in group 1 but not in group 2.
CONCLUSION


Anterior chamber inflammation persists for more than 30 days in a significant proportion of patients after uncomplicated cataract surgery and may be responsible for late onset of cystoid macular edema cases.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03317847.",2020,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"['asymptomatic patients with no signs of inflammation on slit lamp examination', 'Seventy-five patients previously enrolled']","['dexamethasone 0.1% ophthalmic suspension (group\xa01) or bromfenac 0.09% ophthalmic solution', 'optical coherence tomography']","['Anterior chamber inflammation', 'central macular thickness (CMT', 'pseudophakic cystoid macular edema (CME', 'Persistence of Inflammation', 'ocular inflammation', 'Laser flare values', 'mean CMT']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1562105', 'cui_str': 'Bromfenac (as bromfenac sodium) 900 microgram/mL eye solution'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0199933,Laser flare values showed a significant reduction in group 2 compared to group 1 throughout all the follow-up (p < 0.001).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Maria', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Coassin', 'Affiliation': 'Ophthalmology, University Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mastrofilippo', 'Affiliation': 'Clinical Trials and Statistics Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cimino', 'Affiliation': 'Ocular Immunology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Iannetta', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. luifonta@gmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01383-1']
1034,32437187,Task demands modulate the effects of speech on text processing.,"Task-irrelevant background sound can disrupt performance of visually based cognitive tasks. The cross-modal breakdown of attentional selectivity in the context of reading was addressed using analyses of eye movements. Moreover, the study addressed whether task-sensitivity to distraction via background speech on reading was modulated by the cognitive demands of the focal task. Two randomly-assigned groups of native Chinese participants read the same set of Chinese experimental sentences while being exposed to meaningful speech, meaningless (foreign) speech, or silence. For one group, participants were instructed to judge whether the sentences made sense (i.e., semantic acceptability task); for another, participants were instructed to detect whether the sentences contained a noncharacter (i.e., noncharacter detection task). Results showed no significant effect across sound conditions for the noncharacter detection task. For the semantic acceptability task, however, there was a substantial disruptive effect of the meaningfulness of the speech. Compared with reading with meaningless speech or reading in silence, the meaningful speech increased numbers of fixations, regressions, regression path, and total reading times. These results suggest that the disruption of reading by background speech is jointly dependent on the nature of the speech and the task process deployed, thereby favoring an Interference-by-Process account over Interference-by-Content and Attentional Diversion accounts of distraction to reading by background sound. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Results showed no significant effect across sound conditions for the noncharacter detection task.,[],"['native Chinese participants read the same set of Chinese experimental sentences while being exposed to meaningful speech, meaningless (foreign) speech, or silence']","['numbers of fixations, regressions, regression path, and total reading times']",[],"[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241402,Results showed no significant effect across sound conditions for the noncharacter detection task.,"[{'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'Zebo', 'Initials': 'Z', 'LastName': 'Lan', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Academy of Psychology and Behavior.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Marsh', 'Affiliation': 'School of Psychology.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Liversedge', 'Affiliation': 'School of Psychology.'}]","Journal of experimental psychology. Learning, memory, and cognition",['10.1037/xlm0000861']
1035,8444944,Controlled trial of short-course regimens of chemotherapy in the ambulatory treatment of spinal tuberculosis. Results at three years of a study in Korea. Twelfth report of the Medical Research Council Working Party on Tuberculosis of the Spine.,"After exclusions, 265 patients with tuberculosis of the thoracic and/or lumbar spine were followed for three years from the start of treatment. They were randomly allocated to four daily regimens of chemotherapy: 1) isoniazid plus rifampicin for 6 months (6HR, 65); 2) the same drugs as in 1) but for 9 months (9HR, 71); 3) isoniazid plus paraaminosalicylic acid (PAS) or ethambutol for 9 months (9P/EH, 62); or 4) the same drugs as in 3) but for 18 months (18P/EH, 67). All patients were ambulatory from the start of chemotherapy and no form of splintage or support or operation was used in any case. Over half (55%) the patients were children and one-third had sinuses or clinically evident abscesses. At three years a favourable status, defined as no sinus nor clinically evident abscess, no myelopathy with functional impairment, no surgery nor additional chemotherapy, full physical activity with disease quiescent clinically and radiographically, was achieved in 203 patients (77%) and in another 41 (15%) in all respects except radiographically. Only 20 patients (8%) had an unfavourable status the proportion being highest (19%) in the 9P/EH series. Thirteen of these were classified as unfavourable solely because they had needed additional chemotherapy; only seven still had an unfavourable status at three years. The clinical results at three years were thus excellent in all series except the 9P/EH, in which more patients had required additional chemotherapy. In the 88 patients with sinuses or abscesses on admission, the rate of resolution was similar in all the series; most lesions (83%) had resolved by 12 months.(ABSTRACT TRUNCATED AT 250 WORDS)",1993,"In the 88 patients with sinuses or abscesses on admission, the rate of resolution was similar in all the series; most lesions (83%) had resolved by 12 months.(ABSTRACT TRUNCATED AT 250 WORDS)","['All patients were ambulatory from the start of chemotherapy and no form of splintage or support or operation was used in any case', 'spinal tuberculosis', '88 patients with sinuses or abscesses on admission', '265 patients with tuberculosis of the thoracic and/or lumbar spine']","['isoniazid plus rifampicin', 'chemotherapy', 'isoniazid plus paraaminosalicylic acid (PAS) or ethambutol']",['rate of resolution'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449266', 'cui_str': 'Splintage (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0041330', 'cui_str': 'Pott Disease'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}]",[],265.0,0.0169537,"In the 88 patients with sinuses or abscesses on admission, the rate of resolution was similar in all the series; most lesions (83%) had resolved by 12 months.(ABSTRACT TRUNCATED AT 250 WORDS)",[],The Journal of bone and joint surgery. British volume,[]
1036,7096399,The fixation of a proximal tibial polyethylene prosthesis without cement.,,1982,,[],['proximal tibial polyethylene prosthesis without cement'],[],[],"[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]",[],,0.0209451,,"[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Blaha', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Insler', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Freeman', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Revell', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Todd', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1037,31444535,Pelvic floor muscle training for female stress urinary incontinence: a randomised control trial comparing home and outpatient training.,"INTRODUCTION AND HYPOTHESIS


In the literature, it is suggested that supervised pelvic floor muscle training (PFMT) might be the first option treatment for female stress urinary incontinence (SUI). However, inadequate accessibility to health care and scarce individual resources may prevent adherence to the treatment. Our study is aimed at comparing the efficacy of performing PFMT in an outpatient clinic and at home in Brazilian incontinent women, and to verify if home PFMT may be an alternative to those not able to attend the outpatient sessions.
METHODS


A total of 69 women with predominant SUI were randomised into two groups: outpatient PFMT and home PFMT. The primary outcome was the cure of SUI defined as <2 g of leakage in a 20-min pad test. Secondary outcomes were: pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets. The assessments were conducted at baseline and after 3 months of treatment. Statistical analyses consisted of Student's t, Mann-Whitney U, Chi-squared, and Wilcoxon tests, with a 5% cut-off for significance.
RESULTS


A superior objective cure of SUI was observed in the outpatient clinic (62%) compared with the home (28%) PFMT groups (OR: 4.0 [95% CI: 1.4-11.0]; p = 0.011). Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week. The home adherence to the exercises was superior in the outpatient PFMT group only during the first-month training.
CONCLUSIONS


Outpatient PFMT was associated with a higher objective cure of SUI than home PFMT. However, subjective findings show equal benefit of home PFMT providing evidence that this may be an alternative treatment to our population.",2020,"Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week.","['Brazilian incontinent women', 'female stress urinary incontinence (SUI', 'female stress urinary incontinence', '69 women with predominant SUI']","['supervised pelvic floor muscle training (PFMT', 'PFMT', 'Pelvic floor muscle training', 'outpatient PFMT and home PFMT']","['SUI', 'satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage', 'cure of SUI defined as <2\xa0g of leakage in a 20-min pad test', 'pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets']","[{'cui': 'C0231238', 'cui_str': 'Incontinent (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",69.0,0.0554048,"Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week.","[{'ForeName': 'Fátima Faní', 'Initials': 'FF', 'LastName': 'Fitz', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil. fanifitz@yahoo.com.br.'}, {'ForeName': 'Márcia Maria', 'Initials': 'MM', 'LastName': 'Gimenez', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'de Azevedo Ferreira', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Mayanni Magda Perreira', 'Initials': 'MMP', 'LastName': 'Matias', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Maria Augusta Tezelli', 'Initials': 'MAT', 'LastName': 'Bortolini', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Rodrigo Aquino', 'Initials': 'RA', 'LastName': 'Castro', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04081-x']
1038,8496218,Unstable intertrochanteric fracture of the femur. A prospective randomised study comparing anatomical reduction and medial displacement osteotomy.,"We conducted a prospective randomised trial to compare the results of anatomical reduction and medial displacement osteotomy in 127 consecutive patients with unstable intertrochanteric fractures, of whom 109 completed the study. After an average follow-up of 11 months, we found no significant differences in walking ability, social status or failure of fixation in the two groups. Postoperative complication rates and the early mortality rate were not significantly different, but operating time and blood loss were significantly higher in the osteotomy group. With the use of modern sliding hip screws, medial displacement osteotomy is rarely indicated for unstable intertrochanteric fractures.",1993,"After an average follow-up of 11 months, we found no significant differences in walking ability, social status or failure of fixation in the two groups.","['127 consecutive patients with unstable intertrochanteric fractures, of whom 109 completed the study', 'Unstable intertrochanteric fracture of the femur']","['medial displacement osteotomy', 'modern sliding hip screws, medial displacement osteotomy', 'anatomical reduction and medial displacement osteotomy']","['Postoperative complication rates', 'walking ability, social status or failure of fixation', 'operating time and blood loss', 'early mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]","[{'cui': 'C0441527', 'cui_str': 'Medial displacement (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",127.0,0.0199912,"After an average follow-up of 11 months, we found no significant differences in walking ability, social status or failure of fixation in the two groups.","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Desjardins', 'Affiliation': 'University of Montreal, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paiement', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pedlow', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Desloges', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Turcotte', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1039,8376441,A prospective randomised comparison of the dynamic hip screw and the gamma locking nail.,"We made a randomised prospective comparison of the Dynamic Hip Screw and the Gamma locking nail for the internal fixation of 200 petrochanteric femoral fractures in elderly patients. There was less intraoperative blood loss and a lower rate of wound complications in the patients treated by the Gamma nail. They had, however, a high incidence of femoral shaft fracture which we relate in part to implant design. We do not recommend the use of the Gamma nail for these fractures.",1993,There was less intraoperative blood loss and a lower rate of wound complications in the patients treated by the Gamma nail.,['200 petrochanteric femoral fractures in elderly patients'],"['dynamic hip screw and the gamma locking nail', 'Gamma nail', 'Dynamic Hip Screw and the Gamma locking nail']","['rate of wound complications', 'intraoperative blood loss', 'femoral shaft fracture']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0441226', 'cui_str': 'Locking nail (physical object)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]","[{'cui': 'C1096106'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",200.0,0.0167404,There was less intraoperative blood loss and a lower rate of wound complications in the patients treated by the Gamma nail.,"[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Radford', 'Affiliation': ""Department of Fracture and Orthopaedic Surgery, University Hospital, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Needoff', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Webb', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1040,32438639,"Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial.","Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments. We investigated whether the consumption of Concord grape juice (CGJ), rich in anti-inflammatory flavonoids, would be tolerated and safe in individuals with GWI and explored improvement in cognitive function and fatigue. Thirty-six veterans with GWI enrolled in a 24-week randomized, double-blind, Phase I/IIA clinical trial to explore safety, tolerability, and feasibility of 16 ounces daily of commercially available CGJ compared to placebo. Participants completed neurocognitive tests and self-reported surveys at baseline, 12 and 24 weeks. Thirty-one participants (86%) completed the study; no dropouts were related to side effects. Thirty participants (83%) documented ≥80% adherence. There were no statistically significant unadjusted differences between CGJ and placebo groups in change in efficacy measures from baseline to endpoint. We employed general linear regression models controlling for baseline differences between groups which indicated statistically significant improvement in the Halstead Category Test-Russell Revised Version (RCAT) at endpoint in the CGJ group compared to placebo (8.4 points,  p  = 0.04). Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67). CGJ was safe and well-tolerated by veterans with GWI. Our data suggest high tolerability and potential benefit from CGJ in veterans with GWI and can be used to inform future studies of efficacy.",2020,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67).","['Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments', 'Thirty-six veterans with GWI enrolled', 'Gulf War Veterans with Gulf War Illness', 'veterans with GWI']","['CGJ', 'Placebo', 'Dietary Supplementation with Concord Grape Juice', 'consumption of Concord grape juice (CGJ', 'placebo']","['Safety, Tolerability and Efficacy', 'cognitive functioning', 'safe and well-tolerated', 'tolerated and safe', 'Halstead Category Test-Russell Revised Version (RCAT']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C4224777', 'cui_str': 'Concord grape juice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4505444', 'cui_str': 'Halstead Category Test'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.431748,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p  = 0.67).","[{'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Helmer', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Van Doren', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Litke', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Chin-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Lap', 'Initials': 'L', 'LastName': 'Ho', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}, {'ForeName': 'Omowunmi', 'Initials': 'O', 'LastName': 'Osinubi', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17103546']
1041,31460865,A contingency management intervention to reduce cannabis use and time to relapse in early psychosis: the CIRCLE RCT.,"BACKGROUND


Cannabis is the most prevalent illicit substance among people with psychosis, and its use is associated with poorer clinical and social outcomes. However, so far, there has been limited evidence that any treatment is effective for reducing use. Contingency management (CM) is an incentive-based intervention for substance misuse that has a substantial evidence base across a range of substances and cohorts. However, to date there have been no randomised controlled trials (RCTs) of CM as a treatment for cannabis use specifically in psychosis.
OBJECTIVE


To conduct a RCT investigating the clinical effectiveness and cost-effectiveness of CM in reducing cannabis use among Early Intervention in Psychosis (EIP) service users.
DESIGN


The CIRCLE (Contingency Intervention for Reduction of Cannabis in Early Psychosis) trial was a rater-blinded, multicentre RCT with two arms. Participants were randomised 1 : 1 to either an CM arm, in which participants received CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only.
SETTING


EIP services across the Midlands and the south-east of England.
PARTICIPANTS


The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks.
INTERVENTION


The CM intervention offered financial incentives (i.e. shopping vouchers) for cannabis abstinence over 12 once-weekly sessions, confirmed using urinalysis. The maximum value in vouchers that participants could receive was £240.
MAIN OUTCOME MEASURES


The main outcome was time to relapse, operationalised as admission to an acute mental health service or hospital. The primary outcome was assessed at 18 months post inclusion using electronic patient records. Secondary outcomes assessed the clinical effectiveness and cost-effectiveness of the intervention, for which data were collected at 3 and 18 months.
RESULTS


A total of 278 participants were randomised to the CM arm and 273 were randomised to the control arm. In total, 530 (96%) participants were followed up for the primary outcome. There was no significant difference in time to admission between trial arms by 18 months following consent (hazard ratio 1.03, 95% confidence interval 0.76 to 1.40). There were no statistically significant differences in most secondary outcomes, including cannabis use, at either follow-up assessment. There were 58 serious adverse events, comprising 52 inpatient episodes, five deaths and one arrest.
LIMITATIONS


Participant retention was low at 18 months, limiting the assessment of secondary outcomes. A different CM intervention design or reward level may have been effective.
CONCLUSIONS


The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use.
FUTURE WORK


Cannabis use is still a significant clinical concern in this population. A pressing need remains to identify suitable treatments. A wider perspective on the social circumstances of young people with psychosis may be needed for a successful intervention to be found.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN33576045.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 45. See the NIHR Journals Library website for further project information.",2019,"The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use.
","['278 participants', 'early psychosis', 'Psychosis (EIP) service users', 'young people with psychosis', 'The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks', 'EIP services across the Midlands and the south-east of England']","['CM', 'CIRCLE (Contingency Intervention', 'CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only', 'contingency management intervention', 'Contingency management (CM']","['clinical effectiveness and cost-effectiveness of the intervention, for which data', '58 serious adverse events', 'time to admission', '52 inpatient episodes, five deaths and one arrest', 'cannabis use and acute relapse', 'time to relapse, operationalised as admission to an acute mental health service or hospital']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3887134', 'cui_str': 'History of psychosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",278.0,0.342918,"The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use.
","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Luke Sheridan', 'Initials': 'LS', 'LastName': 'Rains', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Marwaha', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Mental Health, Social Work and Interprofessional Learning, Middlesex University, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Health Service and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Clinical Psychology and Clinical Effectiveness, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Rumana Z', 'Initials': 'RZ', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Spencer', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hinton', 'Affiliation': 'Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23450']
1042,31451902,Clinical outcome and success rates of ACI for cartilage defects of the patella: a subgroup analysis from a controlled randomized clinical phase II trial (CODIS study).,"AIM


Cartilage defects of the patella are considered as a problematic entity. Purpose of the present study was to evaluate the outcome of patients treated with autologous chondrocyte implantation (ACI) for cartilage defects of the patella in comparison to patient with defects of the femoral condyles.
PATIENTS AND METHODS


73 patients with a follow-up of 5 years have been included in this subgroup analysis of the randomized controlled clinical trial (RCT). In dependence of defect location, patients were divided into two groups [patella defects (n = 45) and femoral condyle defects (n = 28)]. Clinical outcome was evaluated by the means of the KOOS score at baseline and 6 weeks, 3, 6, 12, 18, 24, 36, 48 and 60 months following ACI.
RESULTS


""Responder rate"" at 60 months (improvement from baseline of > 7 points in the KOOS score) in patients with patella defects was 86.2%. All scores showed a significant improvement from baseline. While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6 (SD 14.0) was observed in patella defects (p = 0.2483).
CONCLUSION


ACI seems an appropriate surgical treatment for cartilage defects of the patella leading to a high success rate. In this study, the clinical outcome in patients with patellar defects was even better than the already excellent results in patients with defects of the femoral condyle even though the study included relatively large defect sizes for both groups (mean defect size 6.0 ± 1.7 and 5.4 ± 1.6 for femur and patella, respectively).",2020,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","['patients with patellar defects', '73 patients with a follow-up of 5\xa0years']","['autologous chondrocyte implantation (ACI', 'ACI']","['KOOS score', 'overall KOOS score', 'patella defects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",73.0,0.129378,"While overall KOOS score at 60 months was 81.9 (SD 18.6) points in femoral condyle defects, a mean of 82.6","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Germany and OCM Clinic, OCM | Orthopädische Chirurgie München, Steinerstrass 6, 83069, Munich, Germany. phniemeyer@gmail.com.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Laute', 'Affiliation': 'Joint and Spine Centre, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zinser', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Vinzenz-Hospital, Dinslaken, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becher', 'Affiliation': 'Department of Orthopedic Surgery, Medical University Annastift Hanover, Hanover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diehl', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Orthopedic Center Munich East, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kolombe', 'Affiliation': 'Traumatology and Reconstructive Surgery, DRK Hospital Luckenwalde, Luckenwalde, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Fay', 'Affiliation': 'Department of Traumatology and Arthroscopic Surgery, Lubinus Clinicum Kiel, Kiel, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Siebold', 'Affiliation': 'Center for Hip, Knee and Foot Surgery, ATOS Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fickert', 'Affiliation': 'Sporthopaedicum Straubing, Straubing, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03264-x']
1043,32133871,Motivational factors for initiating and maintaining physical activity among adults aged over fifty targeted by a tailored intervention.,"Objective:  To provide insight into the motivational working mechanisms (i.e. mediators) of an effective physical activity (PA) intervention for adults aged over fifty. Design:  The mediation model ( N  = 822) was investigated in an RCT for the total intervention population, participants who were not norm-active at baseline (targeting PA initiation) and norm-active participants (targeting PA maintenance) separately. Main Outcome Measures:  Potential mediators (attitude, self-efficacy, intention, action planning and coping planning) of the effect on PA (6-months) were assessed at baseline, 3 and/or 6 months. Results:  The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002). Intention and action planning did not mediate the effect on PA. Self-efficacy, although not significantly influenced by the intervention, was found to be the only motivational variable that predicted change in PA ( B =.164;  p =.007). These results were confirmed among participants initiating PA. Among norm-active participants no significant intervention effects were identified. Conclusion:  The motivational factors cannot explain the intervention effect on PA. Most likely, the effect can be explained by an interaction between the motivational factors together. Differences between participants initiating versus maintaining PA, highlight the importance of performing mediation analyses per subgroup.",2020,"The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002).","['adults aged over fifty', 'adults aged over fifty targeted by a tailored intervention', 'participants who were not norm-active at baseline (targeting PA initiation) and norm-active participants (targeting PA maintenance) separately']",['physical activity (PA) intervention'],"['Potential mediators (attitude, self-efficacy, intention, action planning and coping planning) of the effect on PA (6-months', 'increase in action planning', 'Self-efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0462906,"The intervention resulted in a decrease in intention ( B = -.209;  p =.017), and an increase in action planning ( B =.214;  p =.018) and PA ( B =.220;  p =.002).","[{'ForeName': 'Denise Astrid', 'Initials': 'DA', 'LastName': 'Peels', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Maartje M', 'Initials': 'MM', 'LastName': 'van Stralen', 'Affiliation': 'Faculty of Science, Prevention and Public Health, Amsterdam Public Health Research Institute, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bolman', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Rianne H J', 'Initials': 'RHJ', 'LastName': 'Golsteijn', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Aart N', 'Initials': 'AN', 'LastName': 'Mudde', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Maastricht University Medical Centre+, Maastricht, Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychology, Open University, Heerlen, Netherlands.'}]",Psychology & health,['10.1080/08870446.2020.1734202']
1044,30508132,Predicting organizational readiness to implement HIV prevention with couples using practitioners' intentions: testing a heuristic.,"Couple-based interventions may play a key role in ending the AIDS epidemic. Progress has been made in demonstrating successful implementation of both manual-based and web-based modalities of couple-based HIV prevention in clinical trials. To ensure real world implementation, however, we need a better understanding of how best to prepare organizations to support such interventions. We sought to examine which domains of staff-reported organizational readiness predicted providers' intention to deliver a couple-based HIV-prevention intervention. Organizational readiness was assessed at baseline from 253 facilitators enrolled in a randomized clinical trial testing dissemination and implementation of a couple-based HIV prevention program (2007-2012). Consistent with current organizational-readiness theory, we measured general capacities; capacities specific to a couple-based intervention; and staff motivation to implement the intervention. We used multilevel regression models to examine the influence of these capacities on intention to implement at 6-, 12-, and 18-month follow-up, adjusting for staff age, education, role, years of service, and randomized condition. Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect. Higher organizational resource availability and stronger motivation to facilitate the intervention are key domains that could inform administrator and staff training to strengthen readiness for couple-based programs. However, further research is needed to clarify the role of these domains regarding actual implementation.",2020,"Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect.",[],['couple-based HIV prevention program'],"['organizational resources', 'Organizational readiness', 'better staff motivation']",[],"[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.040838,"Higher perceived organizational resources (B = 0.126, p = .028) and better staff motivation (B = 0.510, p = .009) were significant predictors of increased intention to facilitate Connect.","[{'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work, New York, NY, USA.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'University of Michigan School of Social Work, Ann Arbor, MI, USA.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/iby121']
1045,8376442,Preoperative skin traction for fractures of the proximal femur. A randomised prospective trial.,"We report the results of a randomised trial to determine the effects of skin traction on 252 patients awaiting surgery for fractures of the proximal femur. They were allocated randomly to be nursed free in bed or to receive Hamilton-Russell skin traction. No differences were found between the groups in terms of pain suffered, analgesia required, frequency of pressure sores or ease of operation. The application of skin traction to patients with fractures of the upper femur is time-consuming and we recommend therefore that its routine use should be discontinued.",1993,"No differences were found between the groups in terms of pain suffered, analgesia required, frequency of pressure sores or ease of operation.","['fractures of the proximal femur', 'patients with fractures of the upper femur', '252 patients awaiting surgery for fractures of the proximal femur']","['skin traction', 'nursed free in bed or to receive Hamilton-Russell skin traction', 'Preoperative skin traction']","['pain suffered, analgesia required, frequency of pressure sores or ease of operation']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0278297', 'cui_str': 'Skin traction'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",252.0,0.0126101,"No differences were found between the groups in terms of pain suffered, analgesia required, frequency of pressure sores or ease of operation.","[{'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Anderson', 'Affiliation': 'Leicester Royal Infirmary, England, UK.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Harper', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Connolly', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Badham', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Goodrich', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Gregg', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1046,8376450,Chevron or Wilson metatarsal osteotomy for hallux valgus. A prospective randomised trial.,"We compared the chevron and the Wilson metatarsal osteotomy for hallux valgus in a prospective randomised trial on 87 feet in 51 patients, reviewed at averages of 5.5 and 38 months after operation. The patients in the chevron group returned to work earlier and mobilised faster, but, at the later review, those in the Wilson group had better functional results and were more satisfied with the appearance of the foot. Correction of the hallux valgus angle was better maintained in patients in the Wilson group and they had a better range of motion at the metatarsophalangeal joint; fewer complained of metatarsalgia.",1993,Correction of the hallux valgus angle was better maintained in patients in the Wilson group and they had a better range of motion at the metatarsophalangeal joint; fewer complained of metatarsalgia.,"['87 feet in 51 patients, reviewed at averages of 5.5 and 38 months after operation']","['chevron and the Wilson metatarsal osteotomy', 'Chevron or Wilson metatarsal osteotomy']",[],"[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0443173', 'cui_str': 'Chevron (qualifier value)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]",[],87.0,0.0285759,Correction of the hallux valgus angle was better maintained in patients in the Wilson group and they had a better range of motion at the metatarsophalangeal joint; fewer complained of metatarsalgia.,"[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Klosok', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Pring', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Jessop', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1047,8376436,Intraoperative bupivacaine diminishes pain after lumbar discectomy. A randomised double-blind study.,"A randomised double-blind study was carried out on 60 patients undergoing elective lumbar discectomy. Patients in the study group (n = 30) received an injection of 10 ml of 0.5% bupivacaine into the wound; the control group (n = 30) received none. Postoperative pain was measured by a visual analogue pain scale and by the amount of morphine administered by a patient-controlled analgesia system. Patients in the study group had lower pain scores, used less morphine, waited longer until their first demand for analgesia and reported their postoperative pain to be less severe.",1993,"Patients in the study group had lower pain scores, used less morphine, waited longer until their first demand for analgesia and reported their postoperative pain to be less severe.",['60 patients undergoing elective lumbar discectomy'],"['Intraoperative bupivacaine', 'morphine', 'injection of 10 ml of 0.5% bupivacaine']","['visual analogue pain scale', 'Postoperative pain', 'morphine, waited longer until their first demand for analgesia', 'postoperative pain', 'lower pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",60.0,0.231109,"Patients in the study group had lower pain scores, used less morphine, waited longer until their first demand for analgesia and reported their postoperative pain to be less severe.","[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Milligan', 'Affiliation': 'Withers Orthopaedic Surgical Unit, Musgrave Park Hospital, Belfast, UK.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Macafee', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Fogarty', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ramsey', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1048,32438600,Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.,"Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.",2020,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","['older adults', 'Empty Nest and Retired Populations Online', 'Participants are recruited by online and print flyers as well as in-person at community events']",[],"['recruitment, attrition, data collection, intervention delivery, and acceptability', 'risk of disease, mortality, falls, and cognitive and functional decline']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.103504,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cox', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17103544']
1049,32438716,Photobiomodulation Therapy on Orthodontic Movement: Analysis of Preliminary Studies with a New Protocol.,"This study aimed to investigate the effectiveness of photobiomodulation therapy (PBMT) on the acceleration of orthodontic movements, deriving from its biostimulating and regenerative capacity on soft tissues, consequent to the increase in differentiation, proliferation, and activity of cells that are involved with alveolar bone remodeling. The present randomized controlled trial was conducted on six patients who required extractive orthodontic therapy because their ectopic canines had erupted. A total of eight canines were analyzed, four of which received laser irradiation (i.e., experimental group). Two weeks after the extractions, all canines of the experimental and placebo groups were distalized simultaneously and symmetrically with the laceback retraction technique. The PBMT protocol consisted of four cycles of laser applications, one each on days 0, 3, 7, and 14 of the study, with session treatment durations of 2-4 min. The results of the descriptive analysis on the distal displacement speed of the canines after 1 month of follow-up indicate an average displacement of 1.35 mm for the non-irradiated group and 1.98 mm for the irradiated group. Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines. The low energy density laser used in this study, with the parameters set, was found to be a tool capable of statistically significantly accelerating the distal displacement of canines.",2020,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.",['six patients who required extractive orthodontic therapy because their ectopic canines had erupted'],"['Photobiomodulation Therapy', 'photobiomodulation therapy (PBMT', 'laser irradiation', 'placebo']","['distal displacement of canines', 'distal displacement speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",8.0,0.0304746,"Through inferential analysis, a statistically significant difference ( p  < 0.05) was found between the average speed of the irradiated canines and the control canines.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Impellizzeri', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Horodynski', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fusco', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Palaia', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Polimeni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Romeo', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Ersilia', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Galluccio', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, ""Sapienza"" University of Rome, 00161 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17103547']
1050,31944912,Effect of group reminiscence therapy on depression and perceived meaning of life of veterans diagnosed with dementia at veteran homes.,"Most senior veterans who live in veteran homes in Taiwan have few interpersonal relationships. Aging is often accompanied by solitude and illness, which causes senior veterans to doubt the meaning of life and to lose confidence in the value of life. This study tested the effectiveness of a group reminiscence therapy protocol on the depression and meaning of life among elderly institutionalized veterans. A quasi-experimental design was applied. A convenience sample of older adults was drawn from two veteran homes in southern Taiwan. Participants were assigned to intervention or control groups based on the veterans' homes they attended. The participants in the intervention group carried out group reminiscence therapy for 8 weeks in addition to their daily activities. The participants in the comparison group maintained their daily activities. Both groups were evaluated using the GDS-SF and MLS scale including two aspects of depression mood and meaning of life in weeks 1 and 8. The overall life satisfaction increased significantly over time for the intervention group compared to the comparison group from week 1 to week 8. The group reminiscence therapy programs showed promising effects in improving the depression and meaning of life of older veterans living in veteran homes.",2020,The overall life satisfaction increased significantly over time for the intervention group compared to the comparison group from week 1 to week 8.,"['older adults was drawn from two veteran homes in southern Taiwan', 'veterans diagnosed with dementia at veteran homes', 'Most senior veterans who live in veteran homes in Taiwan', 'older veterans living in veteran homes', 'elderly institutionalized veterans']","['group reminiscence therapy', 'group reminiscence therapy protocol']","['depression and perceived meaning of life', 'daily activities', 'depression and meaning of life', 'GDS-SF and MLS scale including two aspects of depression mood and meaning of life', 'overall life satisfaction']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150321', 'cui_str': 'Rt - reminiscence therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0262868,The overall life satisfaction increased significantly over time for the intervention group compared to the comparison group from week 1 to week 8.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Ching-Teng', 'Affiliation': 'Master Program of Long-Term Care in Aging, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ya-Ping', 'Affiliation': 'Department of Nursing, National Tainan Junior College of Nursing, Tainan, Taiwan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chia-Ju', 'Affiliation': 'College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Hsiu-Yueh', 'Affiliation': 'College of Dental Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Social work in health care,['10.1080/00981389.2019.1710320']
1051,6546759,A comparison between arthroscopic meniscectomy and modified open meniscectomy. A prospective randomised study with emphasis on postoperative rehabilitation.,"Arthroscopy is now well established as a method of diagnosing meniscal lesions, and its advantages have been pointed out in several reports. Arthroscopic surgery, however, is difficult to master, so that for meniscectomy open methods remain commoner. By taking advantage of the new instruments and equipment developed for arthroscopic operations, a modified technique of open meniscectomy, designed to improve the postoperative course, has been developed. In a prospective randomised study, the results after this modified open meniscectomy were comparable with those obtained after arthroscopic operation and were significantly better than those after conventional meniscectomy. The best results of all, however, were those after partial arthroscopic meniscectomy.",1984,"In a prospective randomised study, the results after this modified open meniscectomy were comparable with those obtained after arthroscopic operation and were significantly better than those after conventional meniscectomy.",[],"['arthroscopic meniscectomy and modified open meniscectomy', 'Arthroscopic surgery']",[],[],"[{'cui': 'C0407879', 'cui_str': 'Arthroscopic meniscectomy (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0407878', 'cui_str': 'Open meniscectomy (procedure)'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopic Surgical Procedures'}]",[],,0.0121807,"In a prospective randomised study, the results after this modified open meniscectomy were comparable with those obtained after arthroscopic operation and were significantly better than those after conventional meniscectomy.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hamberg', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gillquist', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lysholm', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1052,31392822,Dulaglutide is an effective treatment for lowering HbA1c in patients with type 2 diabetes regardless of body mass index.,"AIM


To assess the relationship between baseline body mass index (BMI) and glycaemic control in dulaglutide-treated patients, a post hoc analysis was conducted on HbA1c and baseline BMI data from eight AWARD studies, with a total of 5770 patients.
MATERIALS AND METHODS


Changes from baseline in HbA1c data from patients treated with 1.5 mg or 0.75 mg dulaglutide, active comparator or placebo, were analyzed in each study (AWARD-1 to -6, -8 and - 9) at approximately 6 months (26, 24 and 28 weeks, respectively). Within each study, data were analyzed by the following baseline BMI categories: <30, ≥30 to <35, and ≥ 35 kg/m 2  .
RESULTS


In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies. No statistically significant treatment-by-BMI category interactions were found for reductions in HbA1c.
CONCLUSION


This post hoc analysis of eight AWARD studies indicates that baseline BMI does not affect the relative treatment efficacy of dulaglutide as measured by HbA1c change from baseline in any study. Dulaglutide is an effective treatment option for adult patients with type 2 diabetes regardless of their baseline BMI category.",2019,"In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies.","['Changes from baseline in HbA1c data from patients treated with 1.5 mg or 0.75\u2009mg', 'adult patients with type 2 diabetes regardless of their baseline BMI category', 'dulaglutide-treated patients, a post hoc analysis was conducted on HbA1c and baseline BMI data from eight AWARD studies, with a total of 5770 patients', 'patients with type 2 diabetes regardless of body mass index']","['Dulaglutide', 'dulaglutide, active comparator or placebo']",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],5770.0,0.132958,"In this post hoc analysis, 1.5 mg or 0.75 mg dulaglutide treatment achieved statistically significant HbA1c reductions from baseline in all BMI categories (least-squares mean change from -0.62 to -1.75%) across the AWARD studies.","[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Gentilella', 'Affiliation': 'Eli Lilly Italia S.p.A., Sesto Fiorentino, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Surgical Science, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vazquez', 'Affiliation': 'Hospital Marqués de Valdecilla, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Sapin', 'Affiliation': 'Lilly France, Neuilly-sur-Seine, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Reed', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Romera', 'Affiliation': 'Lilly S.A., Alcobendas, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Endocrinology & Diabetes, University Campus Bio-Medico, Rome, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13853']
1053,31450987,Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study.,"INTRODUCTION


Femoral neck fractures are a major problem in orthopaedic practice, having a huge impact on society, and involving a large number of elderly patients for whom early recovery is paramount. Thus, the aim of this study was to compare 2 surgical approaches, direct anterior (DA group) versus posterolateral (PL group), used for bipolar hip hemiarthroplasty (BHA) with femoral neck fractures in order to assess pain recovery after surgery. Our hypothesis was that early pain recovery would be faster in the DA group.
METHODS


100 patients were randomised to surgery using either a DA group or PL group approach, and were then followed up for 6 months. Surgical time, intra- and postoperative complications were recorded for each patient. The main outcome, pain, was recorded using an NRS scale at 3 days, 1, 3 and 6 months after surgery. At the same time, patient status was evaluated using Activities of Daily Living and Cumulated Ambulation Score scales.
RESULTS


Surgical time was longer in the DA group ( p   <  0.0001). Pain perception at 3 days and at 1 month after surgery was significantly lower in DA group patients ( p   <  0.0001). The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
DISCUSSION


The DA approach offers a significant advantage in terms of pain perception up to 1 month after the operation. Early recovery in terms of pain perception is an important finding. Future studies should explore whether this early pain reduction could translate into a faster rehabilitation programme for an earlier recovery of full function.Clinical trial registration: Protocol 423/CE; Study n. CE 41/15.",2020,"The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
","['100 patients', 'bipolar hip hemiarthroplasty in femoral neck fractures']","['DA group or PL group approach', 'bipolar hip hemiarthroplasty (BHA) with femoral neck fractures', 'direct anterior (DA group) versus posterolateral (PL group', 'Direct anterior versus posterolateral approach']","['pain', 'pain perception', 'Activities of Daily Living and Cumulated Ambulation Score scales', 'Surgical time, intra- and postoperative complications', 'pain recovery', 'Surgical time', 'Pain perception']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C1112760', 'cui_str': 'Hip hemiarthroplasty'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral (qualifier value)'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",100.0,0.0508432,"The results of the other scales were comparable in the 2 groups (at 3 days, 1 and 3 months after surgery).
","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Verzellotti', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Candrian', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Molina', 'Affiliation': 'Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Filardo', 'Affiliation': 'Laboratory NABI, Orthopedic Institute Rizzoli, Bologna, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Alberio', 'Affiliation': 'University Hospital Maggiore della Carita, Novara, Italy.'}, {'ForeName': 'Federico A', 'Initials': 'FA', 'LastName': 'Grassi', 'Affiliation': 'University Hospital Maggiore della Carita, Novara, Italy.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019872117']
1054,31126775,"Resurfacing in a Posterior-Stabilized Total Knee Arthroplasty Reduces Patellar Crepitus Complication: A Randomized, Controlled Trial.","BACKGROUND


Patellar crepitus (PC) is a common complication after total knee arthroplasty (TKA) using a posterior-stabilized (PS) prosthesis. While numerous factors have been associated with PC development after PS-TKA, patellar resurfacing (PR) which directly impacts the patellofemoral joint kinematics has been underinvestigated. A prospective, randomized, controlled trial was conducted to (1) compare the PC incidence in PR and non-PR PS-TKA, (2) determine the time of PC presentation in PS-TKA, (3) identify radiographic parameters associated with PC, and (4) compare clinical outcomes of patients with and without PR.
METHODS


A total of 84 patients who underwent unilateral TKA using the Legion PS Total Knee System were randomized into PR group or non-PR group. PC incidence, time of PC presentation, radiographic parameters associated with PC development, and clinical outcomes were evaluated at 3 months, 6 months, 9 months, and 1 year postoperatively.
RESULTS


PC occurred significantly more in the non-PR group (23.1% vs 7.3%, P = .048). Time of PC presentation in both groups was not different. Anterior knee pain was found in 16.7% of crepitus patients, and none required any surgical procedure. The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset. Oxford and patellar scores were significantly better in the PR group at 9 months and 1 year.
CONCLUSION


Given higher PC incidence and several worse clinical outcomes in the non-PR, we recommend resurfacing during PS-TKA with this knee system to avoid PC development.",2019,"The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset.","['patients with and without PR', '84 patients who underwent unilateral TKA using the Legion PS Total Knee System']","['Posterior-Stabilized Total Knee Arthroplasty', 'Resurfacing', 'PR group or non-PR', 'Patellar crepitus (PC', 'posterior-stabilized (PS) prosthesis']","['Oxford and patellar scores', 'Anterior knee pain', 'Time of PC presentation', 'patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset', 'Patellar Crepitus Complication', 'PC incidence, time of PC presentation, radiographic parameters associated with PC development, and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",84.0,0.0651546,"The non-PR knees had significant decreases in patellar shift index, patellar displacement, Insall-Salvati ratio, and patellar component height and increase in change in posterior femoral offset.","[{'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Thiengwittayaporn', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Kakanand', 'Initials': 'K', 'LastName': 'Srungboonmee', 'Affiliation': 'Center of Data Mining and Biomedical Informatics, Faculty of Medical Technology, Mahidol University, Salaya, Nakornpathom, Thailand.'}, {'ForeName': 'Bhakawat', 'Initials': 'B', 'LastName': 'Chiamtrakool', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.050']
1055,8331120,A prospective comparison of Butel and PCA hip arthroplasty.,"We compared two cementless femoral components, the 'isoelastic' Butel stem and the more rigid PCA design, in a randomised, prospective study of 56 patients with a mean follow-up of 4 years (2 to 5). Patients were matched in 28 pairs, and one of each pair was treated with each femoral component. The isoelastic stem gave fewer signs of stress shielding radiologically, but both the Harris hip score and the visual analogue pain scale showed significantly inferior results at the two-year and three-year follow-up. The overall failure rates for the femoral components were 43% for the Butel and 11% for the PCA. These results contrast with those of earlier experimental and clinical studies, in which isoelastic properties appeared to be advantageous. This review emphasises the importance of controlled studies before an altered or new design of prosthesis is released on to the market for general use.",1993,"The isoelastic stem gave fewer signs of stress shielding radiologically, but both the Harris hip score and the visual analogue pain scale showed significantly inferior results at the two-year and three-year follow-up.",['56 patients with a mean follow-up of 4 years (2 to 5'],['Butel and PCA hip arthroplasty'],"['visual analogue pain scale', 'overall failure rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",56.0,0.0224034,"The isoelastic stem gave fewer signs of stress shielding radiologically, but both the Harris hip score and the visual analogue pain scale showed significantly inferior results at the two-year and three-year follow-up.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Jacobsson', 'Affiliation': 'University Hospital, Linköping, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Djerf', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gillquist', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hammerby', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ivarsson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1056,8331125,"Anti-inflammatory drug therapy after arthroscopy of the knee. A prospective, randomised, controlled trial of diclofenac or physiotherapy.","We report a prospective, randomised, controlled trial of the effect of either a non-steroidal anti-inflammatory drug (diclofenac sodium) or physiotherapy on the recovery of knee function after arthroscopy. At 42 days after surgery there was no significant benefit from either form of postoperative treatment compared with the control group. Complications attributable to the anti-inflammatory drug occurred in 9.6% of the patients so treated. Neither the routine administration of a non-steroidal anti-inflammatory agent nor routine physiotherapy is justified after arthroscopy of the knee.",1993,At 42 days after surgery there was no significant benefit from either form of postoperative treatment compared with the control group.,[],"['diclofenac or physiotherapy', 'non-steroidal anti-inflammatory drug (diclofenac sodium) or physiotherapy']",['Complications'],[],"[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0284174,At 42 days after surgery there was no significant benefit from either form of postoperative treatment compared with the control group.,"[{'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Birch', 'Affiliation': 'Solihull Hospital, West Midlands, England, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sly', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Powles', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1057,8331129,"Surgery for curly toe deformity: a double-blind, randomised, prospective trial.",,1993,,['curly toe deformity'],[],[],"[{'cui': 'C0410783', 'cui_str': 'Curly toe (disorder)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}]",[],[],,0.575032,,"[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Hamer', 'Affiliation': ""Department of Orthopaedic Surgery, Children's Hospital, Western Bank, Sheffield, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1058,8245082,Glove perforation during hip arthroplasty. A randomised prospective study of a new taperpoint needle.,"Exposure to blood is a hazard for all surgeons. We assessed the incidence of glove perforation and needlestick injury from a new blunt taperpoint needle designed to penetrate tissues other than skin with the minimum of force. We performed a prospective, randomised trial comparing the incidence of perforations of surgical gloves with the new needle and a standard cutting needle during wound closure after hip arthroplasties. There was at least one glove perforation in 46 of 69 such procedures (67%). The use of the taperpoint needle produced a significant decrease in perforations (p = 0.049).",1993,The use of the taperpoint needle produced a significant decrease in perforations (p = 0.049).,['Glove perforation during hip arthroplasty'],['new needle and a standard cutting needle'],['glove perforation'],"[{'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456898', 'cui_str': 'Cutting needle (physical object)'}]","[{'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]",,0.0209293,The use of the taperpoint needle produced a significant decrease in perforations (p = 0.049).,"[{'ForeName': 'K U', 'Initials': 'KU', 'LastName': 'Wright', 'Affiliation': 'North Tees General Hospital, Hardwick, Stockton-upon-Tees, Cleveland, UK.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Briggs', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1059,8245085,Intra-articular fractures of the calcaneum treated operatively or conservatively. A prospective study.,"We report a prospective trial of 66 patients with intraarticular fractures of the calcaneum. All fractures were assessed by CT. Patients with displaced fractures were randomised to receive either conservative (n = 31) or operative treatment (n = 25). Undisplaced fractures (n = 10) were treated conservatively. Operation involved open reduction of the posterior subtalar joint, and fixation with Kirschner wires. All 66 patients were reviewed at a minimum of one year (mean 23 months). After conservative treatment the undisplaced fractures had slightly better results than the displaced fractures. There was no significant difference in outcome between the operatively and the conservatively treated displaced fractures. We have also documented prospectively the natural history of the injury, which is of use in assessing prognosis for both clinical and medicolegal purposes.",1993,There was no significant difference in outcome between the operatively and the conservatively treated displaced fractures.,"['All 66 patients were reviewed at a minimum of one year (mean 23 months', 'Patients with displaced fractures', '66 patients with intraarticular fractures of the calcaneum']","['conservative', 'operative treatment']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0332715', 'cui_str': 'Intraarticular Fractures'}, {'cui': 'C0006655', 'cui_str': 'Heel Bone'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],66.0,0.0104673,There was no significant difference in outcome between the operatively and the conservatively treated displaced fractures.,"[{'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Parmar', 'Affiliation': 'University Department of Orthopaedic Surgery, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Triffitt', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Gregg', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1060,30852837,"Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate. A Prospective, Double Blind Randomized Study.","PURPOSE


To observe the efficacy of intravenously injected oxycodone intraoperative on postoperative urinary catheter-related bladder discomfort (CRBD).
MATERIALS AND METHODS


Patients with ASA I-III received trans-urethral resection prostate under general anesthesia were observed. Patients were randomized allocated to the group control (n = 45) received placebo and the group oxycodone (n =46 ) received 0.03mg/kg of oxycodone before the end of operative 10min. The incidence and severity (mild, moderate, severe) of CRBD were assessed at 0, 1/2 h, 2 h and 6 h postoperatively. VAS scores were used to assess pain intensity during the same period. Postoperative PCA analgesic sufentanil dose and the incidences of nausea, vomiting, dizziness, over sedation were recorded in these patients.
RESULTS


Compared with the control group, the incidence of CRBD was significantly lower in the oxycodone group at 0 [22 (49 %) vs. 10 (22%); P = .007], 1/2h [18 (40%) vs. 9 (20%); P= .033], 2h [11 (24%) vs. 4 (9%); P = .001]. The severity of CRBD at 0 [mild, 9 (38%) ; moderate 9 (20%), severe 4 (9%)] was lower in the group Q than the controlled group [mild, 4 (38%) P ? .023; moderate 5 (11%), P ?.034, severe 1 (2%), P ? .012]. 1/2 h [mild, 11 (24%) Vs 5(11%), P ? .020]. Compared with the group C, VAS scores were lower in group Q at 0, 1/2h (P ? .001) and significantly decreased sufentanil dosage within 6h ( P= .001). There were no significant differences in the incidence of postoperative adverse effects between two groups.
CONCLUSION


Oxycodone can effectively prevent patients with CRBD after TURP without incurring serious adverse effects.",2019,"Compared with the group C, VAS scores were lower in group Q at 0, 1/2h",['Patients with ASA I-III received'],"['placebo and the group oxycodone', 'oxycodone', 'trans-urethral resection prostate under general anesthesia', 'Oxycodone', 'oxycodone intraoperative', 'Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate']","['severity of CRBD', 'incidence of CRBD', 'incidence and severity (mild, moderate, severe) of CRBD', 'incidence of postoperative adverse effects', 'nausea, vomiting, dizziness, over sedation', 'postoperative urinary catheter-related bladder discomfort (CRBD', 'VAS scores', 'pain intensity', 'sufentanil dosage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",,0.162857,"Compared with the group C, VAS scores were lower in group Q at 0, 1/2h","[{'ForeName': 'Juncheng', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Weng', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Shuqun', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of anesthesiology, Wenzhou people's hospital. No.57 canghou street, Lucheng District of Wenzhou City, Zhejiang province, People Republic of China, 325000.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang Ouhai District of Wenzhou, Zhejiang, P. R. China, 325000.'}]",Urology journal,['10.22037/uj.v0i0.4267']
1061,31343947,Cellular and morphological changes with EAA supplementation before and after total knee arthroplasty.,"Investigate the underlying cellular basis of muscle atrophy (Placebo) and atrophy reduction (essential amino acid supplementation, EAAs) in total knee arthroplasty (TKA) patients by examining satellite cells and other key histological markers of inflammation, recovery, and fibrosis. Forty-one subjects (53-76 yr) scheduled for TKA were randomized into two groups, ingesting 20 g of EAAs or placebo, twice-daily, for 7 days before TKA and for 6 wk after surgery. A first set of muscle biopsies was obtained from both legs before surgery in the operating room, and patients were randomly assigned and equally allocated to have two additional biopsies at either 1 or 2 wk after surgery. Biopsies were processed for gene expression and immunohistochemistry. Satellite cells were significantly higher in patients ingesting 20 g of essential amino acids twice daily for the 7 days leading up to surgery compared with Placebo (operative leg  P  = 0.03 for satellite cells/fiber and  P  = 0.05 for satellite cell proportions for Type I-associated cells and  P  = 0.05 for satellite cells/fiber for Type II-associated cells.) Myogenic regulatory factor gene expression was different between groups, with the Placebo Group having elevated MyoD expression at 1 wk and EAAs having elevated myogenin expression at 1 wk. M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group. EAAs starting 7 days before surgery increased satellite cells on the day of surgery and promoted a more favorable inflammatory environment postsurgery. NEW & NOTEWORTHY  Clinical studies by our group indicate that the majority of muscle atrophy after total knee arthroplasty (TKA) in older adults occurs rapidly, within the first 2 wks. We have also shown that essential amino acid supplementation (EAAs) before and after TKA mitigates muscle atrophy; however, the mechanisms are unknown. These results suggest that satellite cell numbers are elevated with EAA ingestion before surgery, and after surgery, EAA ingestion positively influences markers of inflammation. Combined, these data may help inform further studies designed to address the accelerated sarcopenia that occurs in older adults after major surgery.",2019,"M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group.","['total knee arthroplasty (TKA) patients', 'total knee arthroplasty', 'Forty-one subjects (53-76 yr) scheduled for TKA', 'older adults after major surgery']","['muscle atrophy (Placebo) and atrophy reduction (essential amino acid supplementation, EAAs', 'ingesting 20 g of EAAs or placebo', 'Placebo', 'total knee arthroplasty (TKA']","['satellite cells', 'M1 macrophages', 'TNF-α', 'Satellite cells', 'Myogenic regulatory factor gene expression', 'IL-6 and TNF-α transcripts', 'elevated MyoD expression']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation (product)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0206474', 'cui_str': 'Myogenic Regulatory Factors'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",41.0,0.162478,"M1 macrophages were more prevalent in Placebo than the EAAs Group. IL-6 and TNF-α transcripts were elevated postsurgery in both groups; however, TNF-α declined by 2 wk in the EAAs Group.","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Muyskens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Foote', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Bigot', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Strycker', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Smolkowski', 'Affiliation': 'Oregon Research Institute, Eugene, Oregon.'}, {'ForeName': 'Tessa K', 'Initials': 'TK', 'LastName': 'Kirkpatrick', 'Affiliation': 'Slocum Research and Education Foundation, Eugene, Oregon.'}, {'ForeName': 'Brick A', 'Initials': 'BA', 'LastName': 'Lantz', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Shah', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Mohler', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jewett', 'Affiliation': 'Slocum Center for Orthopedics and Sports Medicine, Eugene, Oregon.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Owen', 'Affiliation': 'Slocum Research and Education Foundation, Eugene, Oregon.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Dreyer', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00869.2018']
1062,31419968,A combination intervention addressing sexual risk-taking behaviors among vulnerable women in Uganda: study protocol for a cluster randomized clinical trial.,"BACKGROUND


Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda.
METHODS


This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n = 330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S + FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S + FL + V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences.
DISCUSSION


When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
TRIAL REGISTRATION


ClinicalTrials.gov , ID: NCT03583541 .",2019,"Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
","['vulnerable women in Uganda', 'women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population']","['economic empowerment to traditional HIV risk reduction (HIVRR', 'Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR\xa0+\xa0S\u2009+\u2009FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR\xa0+\xa0S\u2009+\u2009FL\u2009+\u2009V']",['sexual risk-taking behaviors'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0033595', 'cui_str': 'Sex Industry'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",990.0,0.18682,"Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness.
","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA. fms1@wustl.edu.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'College of Global Public Health, New York University, New York City, NY, USA.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Bloomington, IN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kiyingi', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Rakai, Uganda.'}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Bellamy', 'Affiliation': 'Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Witte', 'Affiliation': 'Columbia University School of Social Work, New York City, NY, USA.'}]",BMC women's health,['10.1186/s12905-019-0807-1']
1063,7263746,Internal fixation versus hemiarthroplasty for the displaced subcapital fracture of the femur. A prospective randomised study.,"A prospective randomised trial of surgical treatment for the displaced subcapital femoral fracture in patients of 70 years or more is presented. Two hundred and eighteen patients were randomly allocated into one of three treatment groups: manipulative reduction and internal fixation using Garden screws; Thompson hemiarthroplasty through a posterior (Moore) approach; and Thompson hemiarthroplasty through an anterolateral (McKee) approach. There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups. Both groups showed a significantly higher mortality than patients operated on through the anterior approach. The technical results of operation were worse in the internally fixed group, with only 40 per cent being satisfactory. Mobilisation was best achieved after the posterior approach. It is concluded that Thompson hemiarthroplasty, using an anterolateral approach, is the safest operation in this group of patients.",1981,There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups.,"['displaced subcapital femoral fracture in patients of 70 years or more is presented', 'Two hundred and eighteen patients']","['surgical treatment', 'manipulative reduction and internal fixation using Garden screws; Thompson hemiarthroplasty through a posterior (Moore) approach; and Thompson hemiarthroplasty through an anterolateral (McKee) approach', 'Internal fixation versus hemiarthroplasty']","['Mobilisation', 'mortality']","[{'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",218.0,0.0188591,There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups.,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Sikorski', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Barrington', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1064,32438401,Mycoprotein ingestion stimulates protein synthesis rates to a greater extent than milk protein in rested and exercised skeletal muscle of healthy young men: a randomized controlled trial.,"BACKGROUND


Mycoprotein is a fungal-derived sustainable protein-rich food source, and its ingestion results in systemic amino acid and leucine concentrations similar to that following milk protein ingestion.
OBJECTIVE


We assessed the mixed skeletal muscle protein synthetic response to the ingestion of a single bolus of mycoprotein compared with a leucine-matched bolus of milk protein, in rested and exercised muscle of resistance-trained young men.
METHODS


Twenty resistance-trained healthy young males (age: 22 ± 1 y, body mass: 82 ± 2 kg, BMI: 25 ± 1 kg·m-2) took part in a randomized, double-blind, parallel-group study. Participants received primed, continuous infusions of L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g (31.5 g protein: 2.5 g leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control). Blood and m. vastus lateralis muscle samples were collected before exercise and protein ingestion, and following a 4-h postprandial period to assess mixed muscle fractional protein synthetic rates (FSRs) and myocellular signaling in response to the protein beverages in resting and exercised muscle.
RESULTS


Mixed muscle FSRs increased following MILK ingestion (from 0.036 ± 0.008 to 0.052 ± 0.006%·h-1 in rested, and 0.035 ± 0.008 to 0.056 ± 0.005%·h-1 in exercised muscle; P <0.01) but to a greater extent following MYCO ingestion (from 0.025 ± 0.006 to 0.057 ± 0.004%·h-1 in rested, and 0.024 ± 0.007 to 0.072 ± 0.005%·h-1 in exercised muscle; P <0.0001) (treatment × time interaction effect; P <0.05). Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
CONCLUSIONS


The ingestion of a single bolus of mycoprotein stimulates resting and postexercise muscle protein synthesis rates, and to a greater extent than a leucine-matched bolus of milk protein, in resistance-trained young men. This trial was registered at clinicaltrials.gov as 660065600.",2020,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","['resistance-trained young men', 'healthy young men', 'Twenty resistance-trained healthy young males (age: 22\xa0±\xa01 y, body mass: 82\xa0±\xa02 kg, BMI: 25\xa0±\xa01 kg·m-2']","['Mycoprotein ingestion', 'leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control', 'L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g', 'leucine-matched bolus of milk protein']","['MILK ingestion', 'postprandial rise in FSRs', 'Postprandial FSRs']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.118269,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","[{'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Doaa R', 'Initials': 'DR', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Thomas S O', 'Initials': 'TSO', 'LastName': 'Jameson', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jackman', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd, Stokesly, North Yorkshire, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa092']
1065,6707051,Pharmacokinetic study of gentamicin-loaded cement in total hip replacements. Comparative effects of varying dosage.,"A randomised, double-blind study was performed in two groups of 15 patients undergoing total hip replacements, using antibiotic-loaded acrylic cement containing 0.5 g and 1.0 g gentamicin base respectively per 40 g pack of powdered polymer. Postoperatively, the gentamicin levels in the blood, in the urine and in the wound drainage fluid were measured. In both groups of patients, the serum gentamicin concentrations were low whereas the wound drainage fluid contained highly effective antibacterial concentrations. Serum, urine and wound secretion levels showed approximately two-fold higher concentrations in the group of patients receiving the higher gentamicin load.",1984,"Serum, urine and wound secretion levels showed approximately two-fold higher concentrations in the group of patients receiving the higher gentamicin load.","['15 patients undergoing total hip replacements, using', 'total hip replacements']","['antibiotic-loaded acrylic cement containing 0.5 g and 1.0 g gentamicin base respectively per 40 g pack of powdered polymer', 'gentamicin-loaded cement']","['Serum, urine and wound secretion levels', 'serum gentamicin concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439509', 'cui_str': 'per 40'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",15.0,0.0699132,"Serum, urine and wound secretion levels showed approximately two-fold higher concentrations in the group of patients receiving the higher gentamicin load.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wahlig', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dingeldein', 'Affiliation': ''}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Buchholz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buchholz', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bachmann', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1066,31447402,Design and research of intelligent motion intervention system for infectious diseases.,"In order to provide a more valuable means of examination, treatment and rehabilitation for patients with chronic diseases by using the intelligent motion control training system, simple obesity, diabetes mellitus, heart disease, hypertension and other four types of chronic diseases with the highest incidence of diseases are taken as the research object. Several patients with each disease are randomly divided into two or three groups to explore the importance of intelligent motor intervention system for patients with chronic diseases during examination, treatment and rehabilitation. The results show that the disease indicators of chronic diseases participated in by intelligent exercise intervention system are improved and decreased in different research diseases. In addition, the intelligent motion intervention system has realized the whole function through four stages: requirement analysis, function design, system implementation and system testing. Finally, it is verified that its function and performance can meet people's needs and achieve the desired goals. At the same time, it provides useful reference for standardizing drug use behavior, improving drug efficacy, reducing adverse reactions, and improving the level of clinical treatment. Thus, under the intervention of intelligent motor system based on K-proximity algorithm, rehabilitation treatment of chronic diseases can not only reduce the physical and mental discomfort of patients, quickly restore their health, but also reduce the pain of patients, reduce anxiety, improve patient satisfaction, shorten the diagnosis and treatment time and reduce the cost of examination, which has obvious improvement effect. Therefore, this study is of great significance for providing a more valuable means of examination, treatment and rehabilitation for patients with chronic diseases.",2020,The results show that the disease indicators of chronic diseases participated in by intelligent exercise intervention system are improved and decreased in different research diseases.,"['Several patients with each disease', 'patients with chronic diseases', 'patients with chronic diseases during examination, treatment and rehabilitation']",['intelligent motor intervention system'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0134734,The results show that the disease indicators of chronic diseases participated in by intelligent exercise intervention system are improved and decreased in different research diseases.,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Hunan international economics university, Hunan 410203, China. Electronic address: xie-lina@hotmail.com.'}]",Journal of infection and public health,['10.1016/j.jiph.2019.07.029']
1067,31435732,Laparoscopy versus robotic-assisted pyeloplasty in children: preliminary results of a pilot prospective randomized controlled trial.,"PURPOSE


The aim of this randomized controlled trial (RCT) is to compare the outcomes of conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP) in the treatment of ureteropelvic junction obstruction (UPJO) in children.
METHODS


A total of 53 patients with UPJO were randomized as LP (Group 1, n: 27) and RALP (Group 2, n: 26). Redo cases and patients with anatomical abnormalities were excluded. Urinary ultrasound was performed at postoperative 3, 6 and 12 months; whereas, diuretic renal scintigraphy was performed at 1 year. Failure was defined as progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse. All parameters were statistically compared.
RESULTS


The mean age of the patients was 55.53 ± 57.25 months. There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel. Mean total operative time in LP group was longer than RALP (139 min vs 105 min, respectively, p = 0.001). The hospital stay was similar between the two groups. After a mean follow-up of 12.43 ± 5.34 months, the complication and success rates were found comparable. Only two patients required re-do pyeloplasty in LP group. The mean total cost of RALP procedure was approximately four times higher than LP.
CONCLUSIONS


This is the first RCT comparing LP and RALP in pediatric population. Both LP and RALP are safe and effective in children with comparable success and complication rates. Operative time was longer for LP; whereas, total cost was higher for RALP.",2020,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","['children', '53 patients with UPJO', 'ureteropelvic junction obstruction (UPJO) in children', 'pediatric population']","['LP and RALP', 'Laparoscopy versus robotic-assisted pyeloplasty', 'RALP', 'LP', 'diuretic renal scintigraphy', 'conventional laparoscopic pyeloplasty (LP) versus robotic-assisted laparoscopic pyeloplasty (RALP']","['progressive hydronephrosis on ultrasound, decline in renal function, or symptom relapse', 'hospital stay', 'Mean total operative time', 'total cost', 'mean total cost of RALP procedure', 'patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel', 'complication and success rates', 'Operative time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521619', 'cui_str': 'Pelvi-ureteric junction obstruction'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0554139', 'cui_str': 'Reconstruction of ureteropelvic junction (procedure)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0227666', 'cui_str': 'Kidney Pelvis'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0536008,"There were no statistical differences between the groups in terms of patient gender, body mass index, laterality, preoperative renal function, renal pelvis antero-posterior diameter and presence of crossing vessel.","[{'ForeName': 'Mesrur Selcuk', 'Initials': 'MS', 'LastName': 'Silay', 'Affiliation': 'Department of Pediatric Urology, Istanbul Gelisim University & Istanbul Memorial Hospital, Istanbul, Turkey. selcuksilay@gmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Danacioglu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Ozel', 'Affiliation': 'Department of Pediatric Surgery, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'M Ihsan', 'Initials': 'MI', 'LastName': 'Karaman', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Caskurlu', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University, Istanbul, Turkey.'}]",World journal of urology,['10.1007/s00345-019-02910-8']
1068,32495208,Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion.,"STUDY DESIGN


Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.
OBJECTIVE


We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.
METHODS


This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.
RESULTS


159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.
CONCLUSION


Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.
LEVEL OF EVIDENCE


II.",2020,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","['adolescent idiopathic scoliosis fusion', '14 sites participating in the MIMO Clinical Trial', 'adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves', 'patients and families considering fusion surgery', '159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients', 'AIS patients with Cobb\u2009>\u200945° were included']",[],"['Minimize Implants Maximize Outcomes (MIMO', 'Implant density']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",159.0,0.204835,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","[{'ForeName': 'A Noelle', 'Initials': 'AN', 'LastName': 'Larson', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. larson.noelle@mayo.edu.'}, {'ForeName': 'Lorena V', 'Initials': 'LV', 'LastName': 'Floccari', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Erickson', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sponseller', 'Affiliation': 'Johns Hopkin University, Baltimore, MD, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Mayo Clinic Shared Decision Making National Resource Center, Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Carl-Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Polytechnique Montreal, Montreal, QC, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Polly', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine deformity,['10.1007/s43390-020-00143-z']
1069,8421029,Timing of antibiotic administration in knee replacement under tourniquet.,Cephamandole levels in serum and drain fluid were measured in 32 knee replacement operations to determine the benefit of an intravenous dose of antibiotic at the time of tourniquet deflation. Concentrations of cephamandole in drain fluid were directly proportional to the serum concentration at the time of tourniquet release. A 'tourniquet-release' dose of antibiotic increased drain fluid concentration threefold.,1993,Concentrations of cephamandole in drain fluid were directly proportional to the serum concentration at the time of tourniquet release.,"['knee replacement under tourniquet', '32 knee replacement operations']","['antibiotic administration', 'cephamandole']",['Cephamandole levels in serum and drain fluid'],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0007541', 'cui_str': 'Cefamandole'}]","[{'cui': 'C0007541', 'cui_str': 'Cefamandole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",32.0,0.0372958,Concentrations of cephamandole in drain fluid were directly proportional to the serum concentration at the time of tourniquet release.,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Richardson', 'Affiliation': 'Southern General Hospital, Glasgow, Scotland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Robertson', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'John', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sweeney', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1070,8421038,Ultrasound or image intensifier for closed femoral nailing.,"We describe a method of closed, unlocked nailing for femoral fractures using ultrasound instead of an image intensifier. Radiography was used only to confirm that the guide wire had been passed into the intramedullary canal of both fragments. The method succeeded in 26 of 30 cases. The failures all occurred in fractures which could not be reduced within 20 minutes. The operating time in those nailed successfully with ultrasound control was not different from the time for 30 control cases using conventional methods with an image intensifier.",1993,The operating time in those nailed successfully with ultrasound control was not different from the time for 30 control cases using conventional methods with an image intensifier.,[],"['Radiography', 'unlocked nailing', 'Ultrasound or image intensifier for closed femoral nailing']",[],[],"[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]",[],,0.0144886,The operating time in those nailed successfully with ultrasound control was not different from the time for 30 control cases using conventional methods with an image intensifier.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mahaisavariya', 'Affiliation': 'Khon Kaen University, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Laupattarakasem', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1071,31349791,"Study protocol and rationale of the ""Cogni-action project"" a cross-sectional and randomized controlled trial about physical activity, brain health, cognition, and educational achievement in schoolchildren.","BACKGROUND


Education and health are crucial topics for public policies as both largely determine the future wellbeing of the society. Currently, several studies recognize that physical activity (PA) benefits brain health in children. However, most of these studies have not been carried out in developing countries or lack the transference into the education field. The Cogni-Action Project is divided into two stages, a cross-sectional study and a crossover-randomized trial. The aim of the first part is to establish the associations of PA, sedentarism, and physical fitness with brain structure and function, cognitive performance and academic achievement in Chilean schoolchildren (10-13 years-old). The aim of the second part is to determinate the acute effects of three PA protocols on neuroelectric indices during a working memory and a reading task.
METHODS


PA and sedentarism will be self-reported and objectively-assessed with accelerometers in a representative subsample, whilst physical fitness will be evaluated through the ALPHA fitness test battery. Brain structure and function will be assessed by magnetic resonance imaging (MRI) in a randomized subsample. Cognitive performance will be assessed through the NeuroCognitive Performance Test, and academic achievement by school grades. In the second part 32 adolescents (12-13 year-old) will be cross-over randomized to these condition (i) ""Moderate-Intensity Continuous Training"" (MICT), (ii) ""Cooperative High-Intensity Interval Training"" (C-HIIT), and (iii) Sedentary condition. Neuroelectric indices will be measures by electroencephalogram (EEG) and eye-tracking, working memory by n-back task and reading comprehension by a reading task.
DISCUSSION


The main strength of this project is that, to our knowledge, this is the first study analysing the potential association of PA, sedentarism, and physical fitness on brain structure and function, cognitive performance, and academic achievement in a developing country, which presents an important sociocultural gap. For this purpose, this project will use advanced technologies in neuroimaging (MRI), electrophysiology (EEG), and eye-tracking, as well as objective and quality measurements of several physical and cognitive health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03894241 Date of register: March 28, 2019. Retrospectively Registered.",2019,"In the second part 32 adolescents (12-13 year-old) will be cross-over randomized to these condition (i) ""","['children', 'Chilean schoolchildren (10-13\u2009years-old', 'schoolchildren']","['Moderate-Intensity Continuous Training"" (MICT), (ii) ', 'Cooperative High-Intensity Interval Training"" (C-HIIT), and (iii) Sedentary condition', 'magnetic resonance imaging (MRI']","['electroencephalogram (EEG) and eye-tracking, working memory by n-back task and reading comprehension by a reading task', 'Cognitive performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",32.0,0.031073,"In the second part 32 adolescents (12-13 year-old) will be cross-over randomized to these condition (i) ""","[{'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Solis-Urra', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Olivares-Arancibia', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Suarez-Cadenas', 'Affiliation': 'Faculty of Sport Science, Pablo de Olavide University, Seville, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanchez-Martinez', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Esteban-Cornejo', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cadenas-Sanchez', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'Departament of Physical Education, Faculty of Education Sciences, University of Cádiz, Puerto real, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Veloz', 'Affiliation': 'Biomedical Engineering Department, Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Steren', 'Initials': 'S', 'LastName': 'Chabert', 'Affiliation': 'Biomedical Engineering Department, Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Kabir P', 'Initials': 'KP', 'LastName': 'Saradangani', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, Universidad San Sebastián, Santiago, Chile.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Zavala-Crichton', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Jairo H', 'Initials': 'JH', 'LastName': 'Migueles', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'Department of Physical and Sports Education, Faculty of Sport Sciences, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Quiroz-Escobar', 'Affiliation': 'Independent Imagenology Center Quintaimagen, Viña del Mar, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Almonte-Espinoza', 'Affiliation': 'Independent Imagenology Center Quintaimagen, Viña del Mar, Chile.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Urzúa', 'Affiliation': 'School of Psychology, Universidad Católica del Norte, Antofagasta, Chile.'}, {'ForeName': 'Constantino D', 'Initials': 'CD', 'LastName': 'Dragicevic', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile.'}, {'ForeName': 'Aland', 'Initials': 'A', 'LastName': 'Astudillo', 'Affiliation': 'CINGS, Centro de Investigación en Ingeniería para la Salud, Universidad de Valparaíso, Valparaíso, Chile.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez-Gassibe', 'Affiliation': 'Sports and Exercise Medicine Resident, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Riquelme-Uribe', 'Affiliation': 'Universidad Adventista de Chile, Chillan, Chile.'}, {'ForeName': 'Marcela Jarpa', 'Initials': 'MJ', 'LastName': 'Azagra', 'Affiliation': 'School of Pedagogy, Pontificia Universidad Católica de Valparaiso, Valparaíso, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cristi-Montero', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaiso, Viña del Mar, Chile. carlos.cristi.montero@gmail.com.'}]",BMC pediatrics,['10.1186/s12887-019-1639-8']
1072,3090049,A prospective trial comparing operative and manipulative treatment of ankle fractures.,A series of 42 ankle fractures have been randomised into two groups respectively undergoing either open reduction and internal fixation or manipulative reduction and plaster. Their progress after removal of all external splintage has been followed using simple gait analysis techniques. There appears to be no difference in the outcome of treatment of the two groups in the early recovery period (up to 20 weeks).,1986,There appears to be no difference in the outcome of treatment of the two groups in the early recovery period (up to 20 weeks).,"['ankle fractures', '42 ankle fractures']",['open reduction and internal fixation or manipulative reduction and plaster'],[],"[{'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}]","[{'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}]",[],,0.0162054,There appears to be no difference in the outcome of treatment of the two groups in the early recovery period (up to 20 weeks).,"[{'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Rowley', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Norris', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Duckworth', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1073,7047536,A 10-year assessment of a controlled trial comparing debridement and anterior spinal fusion in the management of tuberculosis of the spine in patients on standard chemotherapy in Hong Kong. Eighth Report of the Medical Research Council Working Party on Tuberculosis of the Spine.,"One hundred and fifty patients in Hong Kong with a diagnosis of tuberculosis of the thoracic, thoracolumbar or lumbar spine were allocated a random to the ""Hong Kong"" radical resection of the lesion and the insertion of autologous bone grafts (Rad. series) or to debridement of the spinal focus without bone grafting (Deb. series). All patients received daily chemotherapy with para-aminosalicylic acid (PAS) plus isoniazid for 18 months, with streptomycin for the first three months. After exclusions, the main analyses of this report concern 119 patients (58 Rad., 61 Deb.) followed up for 10 years. During the first five years the allocated regimen was modified because of the spinal lesion in 14 patients, but there were no further modifications between five and 10 years. No patient developed a sinus or clinically evident abscess or a neurological abnormality between five and 10 years. Bony fusion occurred earlier and in a higher proportion of patients in the Rad, series but at five and 10 years there was vary little difference between the series. Over the period of 10 years there was a mean increase in vertebral loss of 0.05 of a vertebral body in the Rad. series and 0.23 in the Deb. series. In both series most of this loss occurred in the first 18 months, with very little subsequent change in the next eight and a half years. Over the 10 years there was a mean reduction in the angle of kyphosis in the Rad. series of 1.4 degrees for patients with thoracic and thoracolumbar lesions and 0.5 degrees for those with lumbar lesions. By contrast, in the Deb. series there were mean increases in the angle of 9.8 degrees and 7.6 degrees respectively. In both series most of the changes had occurred early, and persisted subsequently. At 10 years 57 of 58 Rad. and all 61 Deb. patients had a favourable status, 50 (86 per cent) and 54 (89 per cent) respectively on the allocated regimen without modification.",1982,"Bony fusion occurred earlier and in a higher proportion of patients in the Rad, series but at five and 10 years there was vary little difference between the series.","['tuberculosis of the spine in patients on standard chemotherapy in Hong Kong', 'patients with thoracic and thoracolumbar lesions and 0.5 degrees for those with lumbar lesions', 'One hundred and fifty patients in Hong Kong with a diagnosis of tuberculosis of the thoracic, thoracolumbar or lumbar spine']","['daily chemotherapy with para-aminosalicylic acid (PAS) plus isoniazid', 'debridement and anterior spinal fusion', 'Hong Kong"" radical resection of the lesion and the insertion of autologous bone grafts (Rad. series) or to debridement of the spinal focus without bone grafting']","['vertebral loss', 'neurological abnormality']","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030125', 'cui_str': '4-aminosalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.0188055,"Bony fusion occurred earlier and in a higher proportion of patients in the Rad, series but at five and 10 years there was vary little difference between the series.",[],The Journal of bone and joint surgery. British volume,[]
1074,31411903,Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.,"A study conducted in an analogue summer treatment setting showed that when concurrently receiving behavioral intervention, many children with Attention-Deficit Hyperactivity Disorder (ADHD) did not need medication or maximized responsiveness at very low doses. The present study followed participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings. There were 127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to receive or not receive behavioral consultation (BC) at the start of the school year. Children were evaluated by teachers and parents each week to determine if central nervous system stimulant treatment was needed. Children who received BC were approximately half as likely those who did not (NoBC) to initiate medication use each week at school or home and used lower doses when medicated at school. This produced a 40% reduction in total methylphenidate exposure over the course of the school year. BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive. Moreover, BC and NoBC groups did not significantly differ in cost of treatment; although children in the BC condition accrued additional costs via the BC, these costs were offset by the associated delay and reduction in medication use. Results add to a growing literature suggesting that the use of low-intensity behavioral intervention as a first-line treatment reduces or eliminates the need for medication in children with ADHD.",2020,"BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive.","['children with ADHD', 'participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings', 'Children with ADHD', '127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to', 'children with Attention-Deficit Hyperactivity Disorder (ADHD']","['behavioral intervention', 'receive or not receive behavioral consultation (BC', 'First-Line Behavioral Intervention']",['total methylphenidate exposure'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",127.0,0.0272917,"BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive.","[{'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Coles', 'Affiliation': 'Center for Children and Families, Florida International University.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fabiano', 'Affiliation': 'Department of Counseling, School, and Educational Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Gnagy', 'Affiliation': 'Center for Children and Families, Florida International University.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Burrows-MacLean', 'Affiliation': 'Department of Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Wymbs', 'Affiliation': 'Department of Psychology, Ohio University.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chacko', 'Affiliation': 'Department of Applied Psychology, New York University.'}, {'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'Walker', 'Affiliation': 'The Hospital for Sick Children.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wymbs', 'Affiliation': 'Department of Psychology, Ohio University.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Robb Mazzant', 'Affiliation': 'Center for Children and Families, Florida International University.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Garefino', 'Affiliation': 'Department of Psychology, Kennesaw State University.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Hoffman', 'Affiliation': 'Department of Pediatrics, State University of New York at Buffalo.'}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Massetti', 'Affiliation': 'Department of Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Page', 'Affiliation': 'Department of Health Policy and Management, Florida International University.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Waschbusch', 'Affiliation': 'Department of Psychiatry, Pennsylvania State University Milton S. Hershey Medical Center.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Department of Psychiatry, Pennsylvania State University Milton S. Hershey Medical Center.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Center for Children and Families, Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1630835']
1075,6163785,Venous thrombosis and embolism.,,1981,,[],[],['Venous thrombosis and embolism'],[],[],"[{'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}]",,0.0221431,,"[{'ForeName': 'L W', 'Initials': 'LW', 'LastName': 'Lowe', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1076,6368563,Acute rupture of the lateral ligament of the ankle. To suture or not to suture?,"One hundred patients with acute ruptures of the lateral ligaments of the ankle were randomly allocated either to conservative treatment in a plaster cast or to operative repair. With the aid of stress tenography, the extent of the injury was established. There were 30 patients with isolated anterior talofibular ruptures and 20 with additional calcaneofibular ligament ruptures in each treatment group. Operative repair was associated with a higher incidence of complications in the first weeks, and slightly delayed the patients' return to work. At an independent two-year review there was no evidence that operative repair offered improved symptomatic or functional benefit.",1984,"Operative repair was associated with a higher incidence of complications in the first weeks, and slightly delayed the patients' return to work.","['One hundred patients with acute ruptures of the lateral ligaments of the ankle', '30 patients with isolated anterior talofibular ruptures and 20 with additional calcaneofibular ligament ruptures in each treatment group', 'Acute rupture of the lateral ligament of the ankle']",['conservative treatment in a plaster cast or to operative repair'],['symptomatic or functional benefit'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0242592', 'cui_str': 'Lateral Ligament'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0225168', 'cui_str': 'Calcaneofibular Ligament'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0032159', 'cui_str': 'Plaster Casts'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",100.0,0.0393558,"Operative repair was associated with a higher incidence of complications in the first weeks, and slightly delayed the patients' return to work.","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hardcastle', 'Affiliation': ''}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Frenyo', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1077,31808359,Proximal Medial Gastrocnemius Release Versus Open Plantar Fasciotomy for the Surgical Treatment in Recalcitrant Plantar Fasciitis.,"BACKGROUND


Plantar fasciitis is a common cause of foot pain. If conservative treatment fails, there is no consensus as to the best surgical management for recalcitrant plantar fasciitis (RPF). The aim of this study was to compare the results obtained from proximal medial gastrocnemius release (PMGR) with those obtained from open plantar fasciotomy (OPF) in terms of pain, satisfaction, health-related quality of life, and American Orthopaedic Foot & Ankle Society (AOFAS) score.
METHODS


This is a prospective randomized trial conducted between 2012 and 2016. Patients with RPF for at least 9 months were included. Diagnosis was clinically made. The exclusion criteria were neuropathic heel pain; a history of previous foot fracture, surgery, or deformity; rheumatoid arthritis; or the need for long-term analgesic administration. After ruling out other conditions with magnetic resonance or ultrasound imaging, patients were randomized to be operated on with OPF or PMGR independently of the Silfverskjold test. Follow-up was carried out for up to 1 year. The AOFAS, visual analog scale (VAS) for pain, SF-36, and Likert scale for satisfaction were used to evaluate the results obtained. The analysis was done with 21 patients in the OPF group and 15 in the PMGR group. The demographic data (age, sex, body mass index, duration of symptoms, and positivity to the Silfverskjold test) of the groups were comparable.
RESULTS


No differences were found in terms of the AOFAS ( P  = .24), VAS ( P  = .14), or any item of the SF-36. Satisfaction was very good in 85.8% of the PMGR group and 89.5% of the OPF group ( P  = .27). Faster recovery was observed in the PMGR group.
CONCLUSION


OPF and PMGR provided good results for patients with RPF. Neither was superior to the other relative to pain, AOFAS score, satisfaction, or the SF-36. We recommend PMGR as the first option in RPF surgical management in order to avoid potential biomechanical complications related to OPF.
LEVEL OF EVIDENCE


Level I, therapeutic randomized controlled trial.",2020,"No differences were found in terms of the AOFAS ( P  = .24), VAS ( P  = .14), or any item of the SF-36. Satisfaction was very good in 85.8% of the PMGR group and 89.5% of the OPF group ( P  = .27).","['Patients with RPF for at least 9 months were included', '21 patients in the OPF group and 15 in the PMGR group', 'patients with RPF', '2012 and 2016', 'Recalcitrant Plantar Fasciitis']","['proximal medial gastrocnemius release (PMGR) with those obtained from open plantar fasciotomy (OPF', 'OPF', 'magnetic resonance or ultrasound imaging', 'PMGR', 'OPF and PMGR', 'Open Plantar Fasciotomy']","['Proximal Medial Gastrocnemius Release', 'pain, satisfaction, health-related quality of life, and American Orthopaedic Foot & Ankle Society (AOFAS) score', 'VAS', 'AOFAS', 'SF-36. Satisfaction', 'Faster recovery', 'AOFAS, visual analog scale (VAS) for pain, SF-36, and Likert scale for satisfaction', 'pain, AOFAS score, satisfaction, or the SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2937234', 'cui_str': 'Fasciotomy of foot (procedure)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",,0.0454746,"No differences were found in terms of the AOFAS ( P  = .24), VAS ( P  = .14), or any item of the SF-36. Satisfaction was very good in 85.8% of the PMGR group and 89.5% of the OPF group ( P  = .27).","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gamba', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autonoma Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Serrano-Chinchilla', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Ares-Vidal', 'Affiliation': 'Department of Radiology and Radiodiagnostic, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Solano-Lopez', 'Affiliation': 'Department of Radiology and Radiodiagnostic, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Gonzalez-Lucena', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autonoma Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ginés-Cespedosa', 'Affiliation': 'Orthopaedic Department, Hospital del Mar, Universitat Autonoma Barcelona (UAB), Barcelona, Spain.'}]",Foot & ankle international,['10.1177/1071100719891979']
1078,6389558,Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts.,"The use of Orthoplast cast-bracing to allow early hand function in the treatment of displaced Colles' fractures was investigated in 243 patients. They were randomly allocated into three groups: in the first a conventional Colles' type plaster was used; in the second an above-elbow cast-brace with the forearm in supination; and in the third a below-elbow cast-brace. Radiographic measurements were made at each stage of treatment, and the final anatomical result was scored using Sarmiento's (1975) criteria. Function was assessed at three months and at six months. The anatomical result was not influenced by the method of immobilisation but was related to the efficacy of reduction. Loss of position in the braces was no greater than in plaster. The functional result at three months also was uninfluenced by the method of immobilisation; it was, however, related to the severity of the initial displacement, and (to a lesser degree) to the anatomical result, an effect which was lost at six months. Early hand function and the supinated position advocated by Sarmiento were found to confer no anatomical or functional advantage; we could see no reason to change from the use of conventional plaster casts in the treatment of uncomplicated Colles' fractures.",1984,Early hand function and the supinated position advocated by Sarmiento were found to confer no anatomical or functional advantage; we could see no reason to change from the use of conventional plaster casts in the treatment of uncomplicated Colles' fractures.,"['243 patients', ""Colles' fractures""]","['Functional cast-bracing', ""conventional Colles' type plaster was used; in the second an above-elbow cast-brace with the forearm in supination; and in the third a below-elbow cast-brace"", 'Orthoplast cast-bracing', 'conventional plaster casts', 'cast-bracing and conventional plaster casts']",['Radiographic measurements'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C2317447', 'cui_str': 'Cast brace (physical object)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0438837', 'cui_str': 'Below elbow cast'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0069664', 'cui_str': 'Rubber, synthetic'}, {'cui': 'C0032159', 'cui_str': 'Plaster Casts'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",243.0,0.0145905,Early hand function and the supinated position advocated by Sarmiento were found to confer no anatomical or functional advantage; we could see no reason to change from the use of conventional plaster casts in the treatment of uncomplicated Colles' fractures.,"[{'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Innes', 'Affiliation': ''}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Burke', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1079,6389559,Keller's arthroplasty: is distraction useful? A prospective trial.,"There are many operations for hallux valgus and hallux rigidus, but Keller's operation remains one of the most popular, particularly for the older patient. A prospective trial was carried out to compare the results of Keller's operation modified by Kirschner-wire distraction with those of the standard operation. The results suggest that there is no advantage in using temporary Kirschner-wire distraction; indeed, degenerative changes in the interphalangeal joint and a subjectively worse result may result from its use.",1984,A prospective trial was carried out to compare the results of Keller's operation modified by Kirschner-wire distraction with those of the standard operation.,"[""Keller's arthroplasty""]",['Kirschner-wire distraction with those of the standard operation'],[],"[{'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",[],,0.0114066,A prospective trial was carried out to compare the results of Keller's operation modified by Kirschner-wire distraction with those of the standard operation.,"[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Sherman', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Douglas', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Benson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
1080,32249034,Health literacy and education level correlates of participation and outcome in a remotely delivered epilepsy self-management program.,"SIGNIFICANCE


Health literacy, the ability to understand necessary health information to make proper health decisions, has been linked to greater frequency of hospitalizations. However, there is limited literature on the associations between health literacy and outcomes in patients with epilepsy, and thus, this secondary analysis investigates the associations between health literacy and outcomes in patients with epilepsy enrolled in the self-management intervention ""Self-management for people with epilepsy and a history of negative events"" (SMART). We examined the associations between higher health literacy and higher education level and outcomes of the SMART trial.
METHODS


This is a secondary analysis of data from the SMART self-management intervention, where individuals were randomized to the SMART intervention or a 6-month waitlist (WL) control. Health literacy was assessed at baseline before randomization using the Rapid Estimate of Adult Literacy in Medicine (REALM-R). Education level was self-reported by participants at baseline. Pearson correlations between REALM-R scores and continuous demographic and clinical variables were conducted. Point-biserial Pearson correlations were computed for REALM-R and dichotomous variables. The effect of education on change in negative health events (NHEs) counts from baseline to six months was conducted using a linear regression. A logistic regression with health literacy and randomization arm as predictors and improvement in NHE (1 = improvement, 0 = no change or increased NHEs at 6 months) as the outcome was conducted.
RESULTS


Lower education and lower income were significantly correlated with lower health literacy (p < 0.001 and p = 0.03). Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045). Health literacy was not associated with change in NHEs or with study retention.
CONCLUSIONS


The SMART intervention appears effective for individuals regardless of health literacy competency. Nevertheless, individuals with higher levels of education have fewer epilepsy complications, and thus, those with limited education may still require additional support while participating in epilepsy self-management programs.",2020,"Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045).","['patients with epilepsy enrolled in the self-management intervention ""Self-management for people with epilepsy and a history of negative events"" (SMART', 'patients with epilepsy']",['SMART intervention'],"['total 6-month NHEs', 'Health literacy', 'lower health literacy', '6-month seizure counts', 'negative health events (NHEs) counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0074785', 'cui_str': 'Sodium-Hydrogen Antiporter'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0431183,"Higher education level was associated with a greater improvement in 6-month seizure counts (r s (105) = 0.29, p = 0.002), and a greater improvement in total 6-month NHEs (r s (95) = 0.20, p = 0.045).","[{'ForeName': 'Shwetha', 'Initials': 'S', 'LastName': 'Sudhakar', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH, USA. Electronic address: sxs1963@case.edu.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University School of Nursing, Louis Stokes Cleveland VAMC, Cleveland, OH, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine Cleveland, OH, USA.'}, {'ForeName': 'Jocasta', 'Initials': 'J', 'LastName': 'Wenk', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Farren B S', 'Initials': 'FBS', 'LastName': 'Briggs', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Pyatka', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Blixen', 'Affiliation': 'Department of Psychiatry and Neurological and Behavioral Outcomes, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine Cleveland, OH, USA; Department of Psychiatry, Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107026']
1081,32134758,Randomized trial of intracoronary adenosine as adjunctive therapy for prevention of the no-reflow phenomenon.,"No-reflow phenomenon as a serious complication following percutaneous coronary intervention, deteriorates clinical outcomes. Intracoronary (IC) Adenosine, seems to be a way to deal with it. One hundred four consecutive patients with ST-segment elevation myocardial infarction were randomized into two groups. Each group consisted of 52 patients who managed with two bolus doses of IC Adenosine (Adenosine group) or two bolus doses of IC normal saline (placebo group) administered before and after stenting. Thrombolysis in myocardial infarction (TIMI) grade flow, ST-segment resolution (STR) and post-procedural clinical outcomes were used as endpoints. IC adenosine led to lower rates of no-reflow based on TIMI grade flow scaling (15.4% vs. 44.3%; P-value: 0.02). STR classified as complete, partial and no resolution was similar between two groups (P-value: 0.748). Also, post-interventional clinical outcomes, including arrhythmia, left ventricular ejection fraction, hospitalization time, and 30 days mortality were similar between Adenosine and placebo groups.",2020,"STR classified as complete, partial and no resolution was similar between two groups (P-value: 0.748).","['52 patients who managed with two bolus doses of', 'One hundred four consecutive patients with ST-segment elevation myocardial infarction']","['IC adenosine', 'IC Adenosine (Adenosine group) or two bolus doses of IC normal saline (placebo', 'Intracoronary (IC) Adenosine', 'intracoronary adenosine']","['arrhythmia, left ventricular ejection fraction, hospitalization time, and 30 days mortality', 'myocardial infarction (TIMI) grade flow, ST-segment resolution (STR) and post-procedural clinical outcomes', 'rates of no-reflow based on TIMI grade flow scaling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0222045'}]",104.0,0.0789274,"STR classified as complete, partial and no resolution was similar between two groups (P-value: 0.748).","[{'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Naghshtabrizi', 'Affiliation': 'Department of Cardiology, Tehran University of Medical Science, Tehran.'}, {'ForeName': 'Manijeh', 'Initials': 'M', 'LastName': 'Sajedi', 'Affiliation': 'School of Medicine, Hamadan University of Medical Sciences.'}, {'ForeName': 'Behshad', 'Initials': 'B', 'LastName': 'Naghshtabrizi', 'Affiliation': 'Department of Cardiology, Hamadan University of Medical Science.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Mozayanimonfared', 'Affiliation': 'Department of Cardiology, Hamadan University of Medical Science.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Ali Seif Rabiei', 'Affiliation': 'Hamadan University of Medical Science, Hamadan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kanonisabet', 'Affiliation': 'Department of Cardiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Coronary artery disease,['10.1097/MCA.0000000000000863']
1082,32496397,Early Inflammatory Measures and Neurodevelopmental Outcomes in Preterm Infants.,"BACKGROUND


Inflammation may be an important predictor of long-term neurodevelopment in preterm infants. The identification of specific inflammatory biomarkers that predict outcomes is an important research goal.
OBJECTIVES


The purpose of this analysis was to identify associations between an early measure of inflammation and neurodevelopment in very preterm infants and to identify differences in the relationship between inflammation and neurodevelopment based on infant gender and race.
METHODS


We conducted a secondary analysis of data from a randomized controlled trial of a caregiving intervention for preterm infants born less than 33 weeks postmenstrual age. Plasma was collected with a clinically indicated laboratory draw by neonatal intensive care unit nurses and analyzed by multiplex assay for cytokines, chemokines, and growth factors. Neurobehavior was assessed by research nurses at the time of discharge from the neonatal intensive care unit using the motor development and vigor and alertness/orientation clusters from the Neurobehavioral Assessment of the Preterm Infant. Neurodevelopment was assessed at 6 months corrected age by the developmental specialist in the hospital's neonatal follow-up clinic using the Bayley Scales of Infant Development, Third Edition. We used linear regressions to estimate the effect of cytokine levels on neurodevelopment and allowed the effects to differ by infant gender and race.
RESULTS


In a sample of 62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with 6-month neurodevelopmental assessments, we found inconsistent associations between single-time point inflammatory measures and neurobehavior or neurodevelopment in analyses of the total sample. However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant gender and race.
DISCUSSION


Although early single-time point measures of inflammation may be insufficient to predict neurodevelopment for all preterm infants, the effect of inflammation appears to differ by infant gender and race. These demographic factors may be important considerations for future studies of inflammation and neurodevelopment as well was the development of future interventions to optimize outcomes.",2020,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","['very preterm infants', 'preterm infants born less than 33 weeks post-menstrual age', 'preterm infants', '62 preterm infants with discharge neurobehavioral assessments and a sample of 40 preterm infants with six month neurodevelopmental assessments']",['caregiving intervention'],[],"[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],62.0,0.0941311,"However, regressions with interactions revealed effects for multiple inflammatory measures on early neurobehavior and neurodevelopment that differed by infant sex and race.
","[{'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': 'Marliese Dion Nist, PhD, RNC-NIC, is Postdoctoral Scholar, The Ohio State University College of Nursing, Columbus. Abigail B. Shoben, PhD, is Associate Professor, Division of Biostatistics, The Ohio State University College of Public Health, Columbus. Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Endowed Professor of Child and Adolescent Health, The Ohio State University College of Nursing, Columbus.'}, {'ForeName': 'Abigail B', 'Initials': 'AB', 'LastName': 'Shoben', 'Affiliation': ''}, {'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000448']
1083,30698277,The Capricious Nature of Theory of Mind: Does Mental State Understanding Depend on the Characteristics of the Target?,"Using a between-groups design and random assignment, this study examined 214 Turkish children's (M = 11.66 years) mindreading and general reasoning about in-group members (Turks), similar out-group members (Syrians within Turkey) and dissimilar out-group members (Northern Europeans). Children heard four mindreading and four general reasoning stories with in-group or out-group members as targets. Whereas children's general reasoning about three groups was equivalent, accuracy of mental state inferences differed by target with more accurate mindreading of in-group targets compared to both sets of out-group targets. In this Turkish sample, mindreading of Syrian targets was the least accurate. Prejudice and perceived realistic threat predicted lower mindreading. These findings have important implications for understanding how similarity and intergroup processes play a role in children's mindreading.",2020,"Whereas children's general reasoning about three groups was equivalent, accuracy of mental state inferences differed by target with more accurate mindreading of in-group targets compared to both sets of out-group targets.","[""214 Turkish children's (M\xa0=\xa011.66\xa0years""]","['mindreading and general reasoning about in-group members (Turks), similar out-group members (Syrians within Turkey) and dissimilar out-group members (Northern Europeans']",[],"[{'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar (qualifier value)'}]",[],214.0,0.0214901,"Whereas children's general reasoning about three groups was equivalent, accuracy of mental state inferences differed by target with more accurate mindreading of in-group targets compared to both sets of out-group targets.","[{'ForeName': 'Seçil', 'Initials': 'S', 'LastName': 'Gönültaş', 'Affiliation': 'Koç University.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Selçuk', 'Affiliation': 'Koç University.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Slaughter', 'Affiliation': 'University of Queensland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hunter', 'Affiliation': 'University of Otago.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Ruffman', 'Affiliation': 'University of Otago.'}]",Child development,['10.1111/cdev.13223']
1084,32170751,Routine glucose assessment in the emergency department for detecting unrecognised diabetes: a cluster randomised trial.,,2020,,[],[],[],[],[],[],,0.0954482,,"[{'ForeName': 'Spiros', 'Initials': 'S', 'LastName': 'Fourlanos', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, VIC.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Barmanray', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, VIC.'}, {'ForeName': 'Mervyn', 'Initials': 'M', 'LastName': 'Kyi', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, VIC.'}]",The Medical journal of Australia,['10.5694/mja2.50550']
1085,32170756,Routine glucose assessment in the emergency department for detecting unrecognised diabetes: a cluster randomised trial.,,2020,,[],[],[],[],[],[],,0.0954482,,"[{'ForeName': 'N Wah', 'Initials': 'NW', 'LastName': 'Cheung', 'Affiliation': 'Westmead Hospital, Sydney, NSW.'}, {'ForeName': 'Lesley V', 'Initials': 'LV', 'LastName': 'Campbell', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': 'Australian Catholic University Nursing Research Institute, Sydney, NSW.'}]",The Medical journal of Australia,['10.5694/mja2.50549']
1086,32503390,Effect of Hydrogen Peroxide Photoactivated Decontamination Using 940 nm Diode Laser in Periodontal Treatment: A Pilot Study.,"Objective:  The aim of this study was to compare the antimicrobial effects of hydroxyl radical generation by photoactivation of hydrogen peroxide (H 2 O 2 ) with diode laser (λ = 940 nm) in combination with conventional nonsurgical periodontal therapy.  Materials and methods:  Thirty-eight patients and 114 teeth were included in this study. The test teeth were randomly assigned to one of the three treatment groups: Group 1 (control group): scaling and root planning (SRP); and the following experimental groups: Group 2: SRP +940 nm diode laser; Group 3: SRP+photoactivation of H 2 O 2  with 940 nm diode laser. Clinical examinations, such as periodontal probing depth (PPD), clinical attachment level (CAL), and bleeding on probing (BoP) were performed before and after the treatment. The microbiological evaluation included nine periodontal bacterial species investigated by means of real-time polymerase chain reaction assay before and after the treatment. The clinical and bacterial differences were assessed between the investigated groups.  Results:  The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment. Group 3 showed significant bacterial reduction of the major periodontal bacteria such as  Porphyromonas gingivalis ,  Tannerella forsythia ,  Treponema denticola ,  Prevotella intermedia ,  Peptostreptococcus micros ,  Fusobacterium nucleatum ,  Eubacterium nodatum  ( p  < 0.001) in contrast to the other two groups ( p  > 0.001). Differences between tested groups showed significant results with regard to Group 3.  Conclusions:  The synergistic effect of SRP and photoactivation of H 2 O 2  with 940 nm diode laser offers an efficient and reliable antimicrobial effect in the nonsurgical periodontal treatment approach.",2020,"The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment.",['Materials and methods:  Thirty-eight patients and 114 teeth were included in this study'],"['hydrogen peroxide (H 2 O 2 ) with diode laser (λ\u2009=\u2009940\u2009nm) in combination with conventional nonsurgical periodontal therapy', 'Group 1 (control group): scaling and root planning (SRP', 'Hydrogen Peroxide Photoactivated Decontamination', 'SRP +940\u2009nm diode laser; Group 3: SRP+photoactivation of H 2 O 2  with 940\u2009nm diode laser']","['periodontal indexes (PPD, CAL, and BoP', 'periodontal probing depth (PPD), clinical attachment level (CAL), and bleeding on probing (BoP', 'bacterial reduction of the major periodontal bacteria such as  Porphyromonas gingivalis ,  Tannerella forsythia ,  Treponema denticola ,  Prevotella intermedia ,  Peptostreptococcus micros ,  Fusobacterium nucleatum ,  Eubacterium nodatum', 'total bacteria load']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0031092', 'cui_str': 'Periodontal Indexes'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0242938', 'cui_str': 'Prevotella intermedia'}, {'cui': 'C0030967', 'cui_str': 'Peptostreptococcus'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0085479', 'cui_str': 'Fusobacterium nucleatum'}, {'cui': 'C0317496', 'cui_str': 'Eubacterium nodatum'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.024316,"The total bacteria load was reduced for all three studied groups and all periodontal indexes (PPD, CAL, and BoP) were improved after each treatment.","[{'ForeName': 'Alin Alexandru', 'Initials': 'AA', 'LastName': 'Odor', 'Affiliation': 'Department of Periodontology, Faculty of Dental Medicine, University of Titu Maiorescu, Bucharest, Romania.'}, {'ForeName': 'Edwin Sever', 'Initials': 'ES', 'LastName': 'Bechir', 'Affiliation': 'Department of Oral Rehabilitation and Oclusology, Faculty of Dental Medicine, University of Medicine, Pharmacy, Science and Technology of Târgu-Mureş, Târgu-Mureş, Romania.'}, {'ForeName': 'Doriana Agop', 'Initials': 'DA', 'LastName': 'Forna', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, University of Medicine and Pharmacy Gr.T. Popa Iaşi, Iaşi, Romania.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4718']
1087,32204266,Propolis and honey trigona decrease leptin levels of central obesity patients.,"OBJECTIVE


This study aimed to examine whether honey and propolis Trigona can reduce the level of leptin in central obesity human.
METHODS


It was a quasi-experimental study, population and sample were central obesity and normal weight as control. Sample size was 30 participants taken using purposive sampling.
RESULTS


Intervention as long as 14 days make an increased level of leptin as many as 97.076pg/ml in control group and decreasing respectively 171.803pg/ml and 245.293pg/ml in honey and propolis intervention group, both significant statistically. The dose of honey given was 105mg/days divided into 3 packs, and each pack contains 35mg. The dose of propolis was 60mg/days and divided into 3 capsules, each of it contains 20mg. Intervention as long as 14 days and leptin levels examined using human ELISA Kit three times, that is before intervention, 7 days after the intervention and 14 days after intervention.
CONCLUSION


Honey and propolis Trigona has the ability to decrease leptin level of central obesity participants. These honey bee products are potential to be a dietary supplement for central obesity patients.",2020,"RESULTS


Intervention as long as 14 days make an increased level of leptin as many as 97.076pg/ml in control group and decreasing respectively 171.803pg/ml and 245.293pg/ml in honey and propolis intervention group, both significant statistically.","['central obesity participants', 'central obesity patients']","['Propolis and honey trigona', 'honey and propolis', 'Honey and propolis']",['level of leptin'],"[{'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0019906', 'cui_str': 'Honey'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",,0.0280513,"RESULTS


Intervention as long as 14 days make an increased level of leptin as many as 97.076pg/ml in control group and decreasing respectively 171.803pg/ml and 245.293pg/ml in honey and propolis intervention group, both significant statistically.","[{'ForeName': 'Rosdiana', 'Initials': 'R', 'LastName': 'Natsir', 'Affiliation': 'Department of Biochemistry, Medicine Faculty, Hasanuddin University, Indonesia.'}, {'ForeName': 'Andi Nilawati', 'Initials': 'AN', 'LastName': 'Usman', 'Affiliation': 'Department of Midwifery, Graduate School, Hasanuddin University, Indonesia. Electronic address: andinilawati@pasca.unhas.ac.id.'}, {'ForeName': 'Bau Dilam', 'Initials': 'BD', 'LastName': 'Ardyansyah', 'Affiliation': 'Department of Biochemistry, Medicine Faculty, Hasanuddin University, Indonesia.'}, {'ForeName': 'Fendi', 'Initials': 'F', 'LastName': 'Fendi', 'Affiliation': 'Research Institution and Community Service, Wuna Agricultural Science University, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.043']
1088,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8']
1089,32500519,The impact of athletic clothing style and body awareness on motor performance in women.,"The type of clothing worn, revealing versus concealing, can affect the performance of women on cognitive tasks. This difference in performance may arise because of changes in body awareness that may draw cognitive resources from the goal task. The present study investigated the influence of the style of athletic clothing and body awareness on visual-motor performance in women. Participants (women ages 18-35 years) were randomly assigned to wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing. All participants completed the same visual-motor aiming task to assess spatiotemporal measures of motor performance. In addition to the clothing, participants were primed to be conscious of their bodies via measurements of height, weight, and waist circumference; photographs taken of their bodies; a computerized body-size distortion task; and a mirror in the testing chamber. Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group. These differences suggest that style of clothing may influence motor performance in women by reallocating cognitive resources towards the body and away from the motor task at hand. This research highlights the interactions between cognitive and motor processes and, potentially, the importance of considering the impact of clothing on performance in many different contexts.",2020,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"['Participants (women ages 18-35 years', 'women']","['wear tight and revealing (TR group, n = 40) or loose and concealing (LC group, n = 40) athletic clothing', 'athletic clothing and body awareness', 'athletic clothing style and body awareness']","['visual-motor performance', 'movement time variability', 'motor performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.11005,Results revealed that the TR group had increased movement time variability and did not show performance improvements relative to the LC group.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Department of Psychology, Faculty of Arts & Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Mental Health and Physical Activity Research Centre, Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Karlinsky', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Manzone', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Neyedli', 'Affiliation': 'Kinesiology, School of Health and Human Performance, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Welsh', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, Toronto, Ontario, Canada. t.welsh@utoronto.ca.'}]",Psychonomic bulletin & review,['10.3758/s13423-020-01755-2']
1090,32497599,"Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial.","OBJECTIVE


To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial.
SETTING


Seven university hospitals in the Republic of Korea.
PARTICIPANTS


Patients (N=220) with poststroke upper limb spasticity.
INTERVENTIONS


All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group).
MAIN OUTCOME MEASURES


The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention.
RESULTS


The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures.
CONCLUSIONS


MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.",2020,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","['post-stroke upper limb spasticity treatment', '220 patients with post-stroke upper limb spasticity', 'Seven university hospitals in the Republic of Korea PARTICIPANTS', 'patients with post-stroke upper limb spasticity DESIGN']","['onabotulinum toxin A (Botox®', 'MT10107 (Coretox group) or onabotulinum toxin A (Botox group', 'MT10107 (Coretox®']","['modified Ashworth scale (MAS', 'adverse events, vital signs, physical examination findings, and laboratory test results', 'Efficacy and safety', 'MAS scores for all muscles and DAS scores', 'response rate, global assessment of treatment, and safety measures', 'change in wrist flexor spasticity', 'efficacy and safety', 'MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",220.0,0.288437,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","[{'ForeName': 'Junekyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul. Electronic address: mhchun@amc.seoul.kr.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Ko', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.""}, {'ForeName': 'Shi-Uk', 'Initials': 'SU', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul.'}, {'ForeName': 'Deog Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.025']
1091,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959']
1092,32493662,Continuous Magnesium Infusion to Prevent Atrial Fibrillation After Cardiac Surgery: A Sequential Matched Case-Controlled Pilot Study.,"OBJECTIVE


The authors aimed to test whether a bolus of magnesium followed by continuous intravenous infusion might prevent the development of atrial fibrillation (AF) after cardiac surgery.
DESIGN


Sequential, matched, case-controlled pilot study.
SETTING


Tertiary university hospital.
PARTICIPANTS


Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol.
INTERVENTIONS


The magnesium infusion protocol consisted of a 10 mmol loading dose of magnesium sulphate followed by a continuous infusion of 3 mmol/h over a maximum duration of 96 hours or until intensive care unit discharge.
MEASUREMENTS AND MAIN RESULTS


The study groups were balanced except for a lower cardiac index in the intervention cohort. The mean duration of magnesium infusion was 27.93 hours (95% confidence interval [CI]: 24.10-31.76 hours). The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01). Atrial fibrillation occurred in 25 patients (25.3%) in the intervention group and 40 patients (40.4%) in the control group (odds ratio 0.49, 95% CI, 0.27-0.92; p = 0.023). On a multivariate Cox proportional hazards model, the hazard ratio for the development of AF was significantly less in the intervention group (hazard ratio 0.45, 95% CI, 0.26-0.77; p = 0.004).
CONCLUSION


The magnesium delivery strategy was associated with a decreased incidence of postoperative AF in cardiac surgery patients. These findings provide a rationale and preliminary data for the design of future randomized controlled trials.",2020,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","['cardiac surgery patients', 'Tertiary university hospital', 'Matched cohort of 99 patients before and intervention cohort of 99 consecutive patients after the introduction of a continuous magnesium infusion protocol']","['magnesium sulphate', 'Continuous Magnesium Infusion', 'magnesium']","['Atrial Fibrillation', 'hazard ratio for the development of AF', 'serum peak magnesium levels', 'Atrial fibrillation', 'atrial fibrillation (AF', 'mean duration of magnesium infusion']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",99.0,0.324668,"The intervention group had greater serum peak magnesium levels: 1.72 mmol/L ± 0.34 on day 1, 1.32 ± 0.36 on day 2 versus 1.01 ± 1.14 and 0.97 ± 0.13, respectively, in the control group (p < 0.01).","[{'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Osawa', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Fondazione Policlinico Universitario A. Gemelli, Universita Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hessels', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Critical Care, University of Groningen, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Australian and New Zealand Intensive Care Research Centre, Monash University, School of Public Health and Preventive Medicine, Melbourne, Australia.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Siven', 'Initials': 'S', 'LastName': 'Seevanayagam', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matalanis', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Heidelberg, Melbourne, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; Centre for Integrated Critical Care, School of Medicine, The University of Melbourne, Melbourne, Australia. Electronic address: rinaldo.Bellomo@austin.org.au.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.04.006']
1093,32502564,What Is the Impact of Engaging With Natural Environments Delivered Via Virtual Reality on the Psycho-emotional Health of People With Spinal Cord Injury Receiving Rehabilitation in Hospital? Findings From a Pilot Randomized Controlled Trial.,"OBJECTIVES


This study investigated (1) the effect of engaging with 20-minute simulated natural environments delivered via virtual reality (VR) on current mood state and (2) the effect of engaging with multiple VR sessions over a period of a week on the depressive symptoms of people with a spinal cord injury (SCI).
DESIGN


Randomized controlled trial design.
SETTING


Spinal Cord Injury Rehabilitation Unit in Australia.
PARTICIPANTS


Participants (N=24) were assigned to a group engaging in VR sessions during week 1 (group 1, n=10) or week 2 (group 2, n=14).
INTERVENTIONS


The intervention week involved participation in up to three 20-minute VR sessions over 3 consecutive days. The control condition involved regular rehabilitation practice over a week.
MAIN OUTCOME MEASURES


The Patient Health Questionnaire-8 (PHQ-8) was completed prior to the first week (T1), after the first week and prior to the second week (T2), and after the second week (T3). Current feeling states, including depressed/happy, anxious/relaxed, and not feeling good/feeling good, were rated immediately prior and after each VR session.
RESULTS


Levels of happiness, relaxation, and feeling good were significantly higher subsequent to engaging with each VR session. Between-group differences in PHQ-8 scores were significantly greater for participants who experienced the intervention during the first week compared to participants within the control group: intervention participants had significant improvements in psycho-emotional health. Within-group PHQ-8 scores were reduced for each group subsequent to experiencing the intervention; however, differences were not significant.
CONCLUSIONS


Engaging with simulated natural environments delivered via VR can favorably affect the psycho-emotional health of people with SCI receiving rehabilitation in hospital. Future research including larger samples and investigating the effect over a longer time period is required to confirm the findings presented.",2020,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","['people with SCI receiving rehabilitation in hospital', 'Spinal Cord Injury Rehabilitation Unit in Australia', 'Participants (n=24', 'people with spinal cord injury receiving rehabilitation in hospital']","['engaging with 20 minute simulated natural environments delivered via virtual reality (VR', 'group engaging in VR sessions', 'natural environments delivered via virtual reality', 'engaging with multiple VR sessions']","['Levels of happiness, relaxation, and feeling good', 'psycho-emotional health', 'Patient Health Questionnaire-8 (PHQ-8', 'PHQ-8 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0204101', 'cui_str': 'Spinal cord injury rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0262716,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Lakhani', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria; Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland. Electronic address: a.lakhani@latrobe.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland; Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mallison', 'Affiliation': 'Western Sydney University, Penrith, New South Wales.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grimbeek', 'Affiliation': 'Upper Brookfield, Brisbane, Queensland.'}, {'ForeName': 'Izak', 'Initials': 'I', 'LastName': 'Hollins', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland.'}, {'ForeName': 'Col', 'Initials': 'C', 'LastName': 'Mackareth', 'Affiliation': 'Spinal Life Australia, Woolloongabba, Queensland, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.013']
1094,32504284,"N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer.","BACKGROUND


The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC).
METHODS


In this single-arm, 2-stage, phase II study, patients with stages I-III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety.
RESULTS


Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
CONCLUSION


TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.",2020,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
","['early-stage HER2-positive breast cancer (HER2+\u2009BC', 'Thirty eligible patients were enrolled', 'early-stage HER2-positive breast cancer']","['standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen', 'TCH plus L', 'lapatinib (L) to trastuzumab (T', 'docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy', 'N083E', 'TCHL']","['safety and tolerability', 'rate of diarrhea', 'Cardiovascular AE', 'congestive heart failure', 'Diarrhea', 'adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",30.0,0.0277203,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment.
","[{'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Leon-Ferre', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Celyne', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of General Oncology, MD Anderson Cancer Center Bay Area, Nassau Bay, TX, USA.'}, {'ForeName': 'Alejandra T', 'Initials': 'AT', 'LastName': 'Perez', 'Affiliation': 'Breast Cancer Centers, Memorial Cancer Institute, Hollywood, FL, USA.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Hematology/Oncology, Wichita Community Clinical Oncology Program, Wichita, KS, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Carolla', 'Affiliation': 'Department of Hematology/Oncology, Cancer Research for the Ozarks, Springfield, MO, USA.'}, {'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Zon', 'Affiliation': 'Department of Oncology, North Indiana Cancer Research Consortium CCOP, South Bend, IN, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. morenoaspitia.alvaro@mayo.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05709-z']
1095,32245747,Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615.,,2020,,[],['Mobile Closed-Loop Control'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.138398,,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-er06']
1096,32503517,Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial.,"BACKGROUND


About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a ""stretch and tone"" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health.
METHODS


Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable.
RESULTS


Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control).
CONCLUSIONS


This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial.
TRIAL REGISTRATION


ClinicalTrials.gov. NCT02925481. Registered 10-04-16.",2020,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","['women after stillbirth', 'women who have experienced stillbirth', 'Participants (N\xa0=\u200990', 'stillbirth mothers']","['online yoga intervention', 'stretch and tone"" control', 'Online yoga', 'yoga or exercise (low dose (LD), 60\u2009min per week; moderate dose (MD), 150\u2009min per week; and stretch-and-tone control group (STC']","['depression scores', 'symptoms of post traumatic stress disorder (PTSD), depression, and anxiety', 'symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health', 'grief intensity', 'PTSD and depression, and improvements in self-rated health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.104793,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Tempe, USA. Jhuberty@asu.edu.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kurka', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Leiferman', 'Affiliation': 'Colorado School of Public Health, Denver, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gold', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cacciatore', 'Affiliation': 'Arizona State University, Tempe, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02926-3']
1097,32686119,Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial.,"AIM


To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.
METHOD


Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.
RESULTS


Children participating in HABIT showed greater improvements in daily functioning (COPM performance  :  χ   1   2    =9.50, p<0.01; COPM satisfaction  :  χ   1   2    =5.07, p<0.05; PEDI functional skills  :  χ   1   2    =6.81, p<0.01; PEDI caregiver assistance  :  χ   1   2    =6.23, p<0.05) and in the dexterity of the dominant hand (BBT:  χ   1   2    =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.
INTERPRETATION


HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.
WHAT THIS PAPER ADDS


Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT.",2020,"RESULTS


Children participating in HABIT showed greater improvements in daily functioning (COPM performance  :  χ   1   2    =9.50, p<0.01; COPM satisfaction  :  χ   1   2    =5.07, p<0.05; PEDI functional skills  :  χ   ","['children with bilateral cerebral palsy (CP', 'Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20', 'children with bilateral CP', 'children with bilateral cerebral palsy', 'PEDI caregiver assistance  :  χ   1   2    =6.23, p<0.05) and in the dexterity of the dominant hand']","['Hand-arm bimanual intensive therapy', 'Hand-Arm Bimanual Intensive Therapy (HABIT']","['bimanual performance', 'daily functioning, unimanual dexterity, and bimanual performance', 'daily functioning (COPM performance', ""Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",41.0,0.115674,"RESULTS


Children participating in HABIT showed greater improvements in daily functioning (COPM performance  :  χ   1   2    =9.50, p<0.01; COPM satisfaction  :  χ   1   2    =5.07, p<0.05; PEDI functional skills  :  χ   ","[{'ForeName': 'Priscilla R P', 'Initials': 'PRP', 'LastName': 'Figueiredo', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Associação Mineira de Reabilitação, Belo Horizonte, Brazil.'}, {'ForeName': 'Marisa C', 'Initials': 'MC', 'LastName': 'Mancini', 'Affiliation': 'Department of Occupational Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Feitosa', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Claudia M M F', 'Initials': 'CMMF', 'LastName': 'Teixeira', 'Affiliation': 'Associação Mineira de Reabilitação, Belo Horizonte, Brazil.'}, {'ForeName': 'Vanessa P D', 'Initials': 'VPD', 'LastName': 'Guerzoni', 'Affiliation': 'Associação Mineira de Reabilitação, Belo Horizonte, Brazil.'}, {'ForeName': 'Ann-Kristin G', 'Initials': 'AG', 'LastName': 'Elvrum', 'Affiliation': 'Department of Clinical Services, St Olavs Hospital, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Ferre', 'Affiliation': 'Department of Occupational Therapy, Boston University, Boston, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Columbia University, New York, USA.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'BrandÃo', 'Affiliation': 'Department of Occupational Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14630']
1098,32504178,"Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years.","INTRODUCTION


The use of quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction is gaining momentum. Yet, long-term results that compare this procedure with established methods are lacking. The aim of this study was to report and compare long-term results of ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts, both anchored using a hardware-free press-fit fixation technique.
MATERIALS AND METHODS


60 athletes (Tegner score ≥6) with primary ACL rupture were prospectively randomized into two groups. 56 patients were evaluated after a mean duration of 12.2 ± 1.9 months (range 10-14) and 43 patients after 10.3 ± 0.2 years (range 10-11).
RESULTS


On final follow-up, 90% of patients scored very good and good results in the functional Lysholm score (mean 99 ± 7.1, range 74-100 points). Normal or almost normal IKDC score was reported by 84% of the patients (mean 97 ± 9.5, range 60-100 points). The activity level decreased in the Tegner score from median of 7 before injury to 6 after 10 years. The KT-1000 arthrometer showed a difference in the anterior translation of less than 3 mm (mean 1.0 ± 1.2, range - 1 to 5 mm) in 91% of the patients. Significant degeneration was radiologically detected in one patient per group. No tunnel widening was seen in any patient. Up to 97% of all patients were satisfied with the operative procedure. No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results. The only significant difference was in the donor site morbidity. Significantly more patients in the BPTB group had complaints during kneeling both at 1 (p < 0.001) and 10 years (p = 0.019). Squatting was also subjectively more problematic in the BPTB group than in the QTB group both after 1 (p = 0.003) and 10 years (p = 0.046).
CONCLUSIONS


This study shows equally good functional, clinical and radiological long-term results for both hardware-free methods of ACL reconstruction. These results clinically confirm the safety of press-fit anchoring after 10 years. The failure rate in this study was very low, with only one re-rupture in 10 years. The increased donor site morbidity when using the BPTB autograft compared to the QTB autograft supports already reported data. It was also seen in this study for the implant-free press-fit techniques.
STUDY DESIGN


Prospective and randomized, level of evidence 2.",2020,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"['56 patients were evaluated after a mean duration of 12.2\u2009±\u20091.9\xa0months (range 10-14) and 43 patients after 10.3\u2009±\u20090.2\xa0years (range 10-11', 'athletes after 10\xa0years', '60 athletes (Tegner score ≥6) with primary ACL rupture']","['ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts', 'quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction', 'QTB', 'Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique']","['Significant degeneration', 'activity level', 'tunnel widening', 'failure rate', 'functional Lysholm score', 'donor site morbidity', 'anterior translation', 'stability, function and return-to-sport level', 'Normal or almost normal IKDC score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",56.0,0.0289652,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany. abarie@web.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sprinckstub', 'Affiliation': 'Center for Surgery B. Nimis and Dr. T. Sprinckstub, Zur Helde 4, 69168, Wiesloch, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Center for Orthopedics of the Knee, Hopfenstraße 4, 69469, Weinheim, Germany.'}, {'ForeName': 'Ayham', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03508-1']
1099,32503041,Odour reduction interventions for simple pit latrines in rural Ethiopia: a randomized study.,"Pit latrines are promoted in resource-limited settings, but unpleasant odours may deter their use. In this study, latrines in rural Ethiopia were randomized to the addition of cooking ash, the addition of boiling water or neither. Study staff ranked odour on a 6-point scale before and approximately 24 h after intervention. Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21). Larger studies might detect a smaller difference.",2020,"Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21).","['simple pit latrines in rural Ethiopia', 'latrines in rural Ethiopia']",['Odour reduction interventions'],[],"[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0023124', 'cui_str': 'Latrine'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0830342,"Following intervention, odour grades were on average 0.2 points lower (95% confidence interval [CI] 0.7 lower to 0.3 higher) in ash-treated latrines and 0.4 points lower (95% CI 0.9 lower to 0.1 higher) in boiled water-treated latrines, although the difference between the three groups was not statistically significant (p = 0.21).","[{'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Aragie', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dionna M', 'Initials': 'DM', 'LastName': 'Wittberg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Aiemjoy', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Melo', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Meghan J', 'Initials': 'MJ', 'LastName': 'Smith', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, GA, USA.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, CA, USA.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/traa039']
1100,32200006,"Dynamic treatment regimens in small n, sequential, multiple assignment, randomized trials: An application in focal segmental glomerulosclerosis.","Focal segmental glomerulosclerosis (FSGS) is a rare kidney disease with an annual incidence of 0.2-1.8 cases per 100,000 individuals. Most rare diseases like FSGS lack effective treatments, and it is difficult to implement clinical trials to study rare diseases because of the small sample sizes and difficulty in recruitment. A novel clinical trial design, a small sample, sequential, multiple assignment, randomized trial (snSMART) has been proposed to efficiently identify effective treatments for rare diseases. In this work, we review and expand the snSMART design applied to studying treatments for FSGS. The snSMART is a multistage trial that randomizes participants to one of three active treatments in the first stage and then re-randomizes those who do not respond to the initial treatment to one of the other two treatments in the second stage. A Bayesian joint stage model efficiently shares information across the stages to find the best first stage treatment. In this setting, we modify the previously presented design and methods (Wei et al. 2018) such that the proposed design includes a standard of care as opposed to three active treatments. We present Bayesian and frequentist models to compare the two novel therapies to the standard of care. Additionally, we show for the first time how we should estimate and compare tailored sequences of treatments or dynamic treatment regimens (DTRs) and contrast the results from our methods to existing methods for analyzing DTRs from a SMART. We also propose a sample size calculation method for our snSMART design when implementing the frequentist model with Dunnett's correction.",2020,"Focal segmental glomerulosclerosis (FSGS) is a rare kidney disease with an annual incidence of 0.2-1.8 cases per 100,000 individuals.",[],['Focal segmental glomerulosclerosis (FSGS'],[],[],"[{'cui': 'C0017668', 'cui_str': 'Glomerulonephritis, Focal Sclerosing'}]",[],,0.0468296,"Focal segmental glomerulosclerosis (FSGS) is a rare kidney disease with an annual incidence of 0.2-1.8 cases per 100,000 individuals.","[{'ForeName': 'Yan-Cheng', 'Initials': 'YC', 'LastName': 'Chao', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: ycchao@umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Trachtman', 'Affiliation': 'Department of Pediatric Nephrology, NYU Langone Health Hospital, New York, NY 10016, USA.'}, {'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Department of Pediatric Nephrology, University of Michigan Medicine, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105989']
1101,32499069,"Osteosynthesis of Phalangeal Fractures: Biomechanical Comparison of Kirschner Wires, Plates, and Compression Screws.","PURPOSE


The aim of this study was to compare several osteosynthesis techniques (intramedullary headless compression screws, T-plates, and Kirschner wires) for distal epiphyseal fractures of proximal phalanges in a human cadaveric model.
METHODS


A total of 90 proximal phalanges from 30 specimens (index, ring, and middle fingers) were used for this study. After stripping off all soft tissue, a transverse distal epiphyseal fracture was simulated at the proximal phalanx. The 30 specimens were randomly assigned to 1 fixation technique (30 per technique), either a 3.0-mm intramedullary headless compression screw, locking plate fixation with a 2.0-mm T-plate, or 2 oblique 1.0-mm Kirschner wires. Displacement analysis (bending, distraction, and torsion) was performed using optical tracking of an applied random speckle pattern after osteosynthesis. Biomechanical testing was performed with increasing cyclic loading and with cyclic load to failure using a biaxial torsion-tension testing machine.
RESULTS


Cannulated intramedullary compression screws showed significantly less displacement at the fracture site in torsional testing. Furthermore, screws were significantly more stable in bending testing. Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
CONCLUSIONS


Intramedullary compression screws are a highly stable alternative in the treatment of transverse distal epiphyseal phalangeal fractures. Kirschner wires seem to be inferior regarding displacement properties and primary stability.
CLINICAL RELEVANCE


Fracture fixation of phalangeal fractures using plate osteosynthesis may have the advantage of a very rigid reduction, but disadvantages such as stiffness owing to the more invasive surgical approach and soft tissue irritation should be taken into account. Headless compression screws represent a minimally invasive choice for fixation with good biomechanical properties.",2020,"Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
","['30 specimens', 'transverse distal epiphyseal phalangeal fractures', 'distal epiphyseal fractures of proximal phalanges in a human cadaveric model', 'A total of 90 proximal phalanges from 30 specimens (index, ring, and middle fingers']","['plating or screw fixation', 'plate osteosynthesis', 'Intramedullary compression screws', 'fixation technique (30 per technique), either a 3.0-mm intramedullary headless compression screw, locking plate fixation with a 2.0-mm T-plate, or 2 oblique 1.0-mm Kirschner wires', 'Cannulated intramedullary compression screws', 'several osteosynthesis techniques (intramedullary headless compression screws, T-plates, and Kirschner wires', 'Kirschner Wires, Plates, and Compression Screws']","['Displacement analysis (bending, distraction, and torsion']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C4087378', 'cui_str': 'Digital fracture'}, {'cui': 'C0476159', 'cui_str': 'Epiphyseal fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0223792', 'cui_str': 'Bone structure of phalanx of finger'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0230393', 'cui_str': 'Middle finger structure'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011119', 'cui_str': 'Bends'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}]",90.0,0.0130479,"Kirschner wires were significantly less stable than plating or screw fixation in any cyclic load to failure test setup.
","[{'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Rausch', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Harbrecht', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany; Department of Anatomy I, Faculty of Medicine, University of Cologne, Cologne, Germany. Electronic address: andreas.harbrecht@uk-koeln.de.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Kahmann', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany; Institute of Bioengineering, FH Aachen University of Applied Sciences, Jülich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fenten', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Trauma and Orthopedics, Hand and Microsurgery Unit, Rashid Hospital, Dubai Health Authority, Oud Metha, Dubai.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hackl', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Lars P', 'Initials': 'LP', 'LastName': 'Müller', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Staat', 'Affiliation': 'Institute of Bioengineering, FH Aachen University of Applied Sciences, Jülich, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Wegmann', 'Affiliation': 'Faculty of Medicine, University of Cologne, Center for Orthopedic and Trauma Surgery, University Hospital, Cologne, Germany.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.04.010']
1102,32513317,Cracker shape modifies  ad libitum  snack intake of crackers with cheese dip.,"Food and energy intake can be effectively lowered by changing food properties, but little is known whether modifying food shape is sufficient to influence intake. This study investigated the influence of cracker shape and cheese viscosity on ad libitum intake of cracker-cheese combinations. Forty-four participants (thirteen males, 23 (sd 3) years, BMI 21 (sd 2) kg/m2) participated in four late afternoon snack sessions (2 × 2 randomised crossover design). Iso-energetic crackers were baked into flat squares and finger-shape cylindrical sticks and combined with a cheese dip varying in viscosity. Approximately eighty crackers and 500 g cheese dip were served in separate large bowls. Participants consumed crackers with cheese dip ad libitum while watching a movie of 30 min. Dipping behaviour and oral processing behaviour were measured simultaneously by hidden balances under the cheese bowls and video recordings. Cracker intake (28 (sem 1) crackers) of cracker-cheese combinations was not influenced by cracker shape. Cheese intake of cracker-cheese combinations was 15 % higher for flat-squared than finger-shape crackers (131 kJ, P = 0·016), as a larger amount of cheese was scooped with flat-squared crackers (2·9 (sem 0·2) v. 2·3 (sem 0·1) g cheese per dip, P < 0·001) and showed higher eating rate and energy intake rate (P < 0·001). Eating rate over snacking time decreased by reducing bite frequency (P < 0·001) while cheese dip size remained fairly constant (P = 0·12). Larger energy intake from condiments was facilitated by increased cracker surface, and this did not trigger earlier satiation. Changing food carrier surface may be a promising approach to moderate energy intake of often high energy dense condiments, sauces and toppings.",2020,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"['crackers with cheese dip', 'Forty-four participants (13 males, 23±3 years, BMI 21±2 kg/m2) participated in four late afternoon snack sessions [2x2 randomized crossover design']",[],"['Eating rate over snacking time', 'Dipping behaviour and oral processing behaviour', 'eating rate and energy intake rate', 'Cheese intake of cracker-cheese combinations', 'bite frequency']","[{'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0585041', 'cui_str': 'Snack time'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0556187', 'cui_str': 'Cheese intake'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",44.0,0.0651299,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"[{'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'van Eck', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van Stratum', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Achlada', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Goldschmidt', 'Affiliation': ""BEL Group, Structure-Function Research 7-bd de l'Industrie, BP40077, 41102Vendôme Cedex, France.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Scholten', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fogliano', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'TiFN, P.O. Box 557, 6700AN Wageningen, The Netherlands.'}, {'ForeName': 'Dieuwerke', 'Initials': 'D', 'LastName': 'Bolhuis', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002056']
1103,32513277,"Effect of household water treatment with chlorine on diarrhea among children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia: a cluster randomized controlled trial.","BACKGROUND


Diarrheal disease is a leading cause of child mortality and morbidity worldwide. Household water treatment with chlorine significantly reduces morbidity due to waterborne diseases. However, the effect of point-of-use (POU) water treatment in improving the quality of water in areas where POU is not provided free of charge and the effectiveness of home visits in inspiring household members to use POU regularly have not been studied. The objective of this study was to evaluate the effectiveness of drinking water disinfection by chlorination on diarrheal disease reduction among children under the age of 5 years in rural eastern Ethiopia.
METHODS


A cluster randomized controlled trial was carried out in rural Dire Dawa from October 2018 through January 2019. The 405 households were randomized to intervention and control arms and intervention materials were distributed after conducting a baseline survey. This trial evaluated the effectiveness of household drinking water disinfection by chlorination in reducing incidence of diarrhea among children under the age of 5 years. Intervention households received 1.2% sodium hypochlorite with demonstration of its proper use. Participants in the control households continued with their usual habits of water collection and water storage. Generalized estimation equation (GEE) with log link Poisson distribution family and exchangeable correlation matrix was used to compute crude incidence rate ratio (IRR), adjusted IRR and the corresponding 95% confidence intervals.
RESULTS


In the intervention households, in total, 281 cases of diarrhea were documented (8.7 cases per 100 person-weeks observation); in the control households, in total 446 cases of diarrhea were documented (13.8 cases per 100 person-weeks observation). A 36.0% (adjusted IRR = 0.64, 95% CI: 0.57-0.73) reduction in incidence of diarrhea was observed in the intervention arm when compared with the control arm. The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively. Adherence to the intervention was 81.3% as measured by free residual chlorine test.
CONCLUSIONS


In rural areas where diarrhea is the second leading cause of morbidity, water chlorination at the household level using liquid bleach considerably reduced episodes of diarrhea among children under the age of 5 years. Therefore, chlorinating drinking water at the household level may be a valuable interim solution for reducing the incidence of diarrheal diseases until potable water is made accessible to the majority of the population in Dire Dawa Administration and other Ethiopian communities.
TRIAL REGISTRATION


PACTR, PACTR201807815961394. Registered 16 July 2018, www.pactr.org.",2020,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","['Participants in the control households continued with their usual habits of water collection and water storage', 'children under the age of 5 years', '405 households', 'children under the age of 5 years in rural eastern Ethiopia', 'rural Dire Dawa from October 2018 through January 2019', 'children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia']","['drinking water disinfection by chlorination', 'household drinking water disinfection', 'household water treatment with chlorine']","['diarrhea', 'diarrheal disease reduction', 'incidence rate ratio (IRR), adjusted IRR', 'incidence of diarrhea', 'morbidity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0175961', 'cui_str': 'Chlorination'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",405.0,0.0647436,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","[{'ForeName': 'Ephrem Tefera', 'Initials': 'ET', 'LastName': 'Solomon', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia. ephtesol@gmail.com.'}, {'ForeName': 'Sirak', 'Initials': 'S', 'LastName': 'Robele', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Kloos', 'Affiliation': 'University of California, San Francisco Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Bezatu', 'Initials': 'B', 'LastName': 'Mengistie', 'Affiliation': 'Haramaya University, College of Health and Medical Sciences, Harar, Ethiopia.'}]",Infectious diseases of poverty,['10.1186/s40249-020-00680-9']
1104,32512248,"Level of pain intensity, cytokine profiling and microbial load after photodynamic therapy in acute severe pericoronitis.","AIM


We evaluated the efficacy of antimicrobial photodynamic therapy (A-PDT) in the reduction of pain intensity and performed cytokine profiling and measurement of microbiological parameters in patients with acute pericoronitis.
METHODS


Sixty patients with age range 14-19 years were randomized into two groups: 'A-PDT group' which received additional A-PDT with conventional protocol, and 'conventional protocol group' (CPG) without A-PDT. Present pain intensity (PPI) were investigated using McGill Pain Questionnaire (MPQ) and Visual Analogue Scale (VAS). Gingival crevicular fluid were sampled to evaluate the levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α) and quantified using enzyme-linked immunosorbent assay. Microbial plaque was collected to evaluate total counts of Porphyromonas gingivalis and Tannerella forsythia expressed as log colony forming unit (CFU)/mL. Level of pain intensity, cytokine profiling and microbial load were assessed at baseline (B0), and post treatment F 7  (Day 7) and F 14  (Day 14).
RESULTS


A total of 59 patients (30 CPG and 29 A-PDT) completed the clinical trial. Present pain intensity scores statistically significantly reduced from B 0  to F 7  in both treatment groups (p < 0.05). For VAS, both groups showed statistically significant reduction in pain scores at F 14  only when compared with baseline (p < 0.05). There was no inter-group significant difference at any time point for either pain scores (p > 0.05). Only TNF-α showed statistically significant reduction with A-PDT compared to CPG at both F 7  and F 14 . CPG group showed significant reduction for only T. forsythia at both follow-up points. The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7  and F 14 .
CONCLUSION


The results of this study indicate that A-PDT may be a reliable treatment option in pericoronitis for the reduction of TNF-α and microbial load. However, A-PDT does not have any effect in the reduction of pain.",2020,"The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7  and F 14 .
","['acute severe pericoronitis', 'Sixty patients with age range 14-19 years', '59 patients (30 CPG and 29 A-PDT) completed the clinical trial', 'patients with acute pericoronitis']","['photodynamic therapy', ""PDT group' which received additional A-PDT with conventional protocol, and 'conventional protocol group' (CPG) without A-PDT"", 'CPG', 'antimicrobial photodynamic therapy (A-PDT']","['pain scores', 'pain intensity scores', 'levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α) and quantified using enzyme-linked immunosorbent assay', 'reduction of pain', 'microbial counts for P. gingivalis and T. forsythia', 'Level of pain intensity, cytokine profiling and microbial load', 'total counts of Porphyromonas gingivalis and Tannerella forsythia expressed as log colony forming unit (CFU)/mL. Level of pain intensity, cytokine profiling and microbial load', 'pain intensity and performed cytokine profiling and measurement of microbiological parameters', 'McGill Pain Questionnaire (MPQ) and Visual Analogue Scale (VAS', 'Present pain intensity (PPI']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031055', 'cui_str': 'Pericoronitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0341006', 'cui_str': 'Acute pericoronitis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",60.0,0.0549293,"The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7  and F 14 .
","[{'ForeName': 'Mohamed Farouk', 'Initials': 'MF', 'LastName': 'Elsadek', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia; Nutrition and Food Science Department, Helwan University, Cairo, Egypt. Electronic address: mfbadr@ksu.edu.sa.'}, {'ForeName': 'Badreldin Mohamed', 'Initials': 'BM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Rayan M', 'Initials': 'RM', 'LastName': 'Eskandrani', 'Affiliation': 'Clinical Specialist in Restorative Dentistry, Department of Restorative Dentistry, Ministry of Health Riyadh, Riyadh, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101830']
1105,32514638,Invited Discussion on: Effect of Photobiomodulation on Ecchymosis After Rhinoplasty-A Randomized Single-Blind Controlled Trial.,,2020,,[],['Photobiomodulation'],['Ecchymosis'],[],[],"[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",,0.0949956,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Iran University of Medical Sciences, St. Fatima Hospital and Burn Research Center, Suite 12, Number 33, Asef St., Zaferanieh, Tehran, 1988893337, Iran. fhafezi32@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01795-y']
1106,32511726,Intra-Individual Variability in Sleep Schedule: Effects of an Internet-Based Cognitive-Behavioral Therapy for Insomnia Program and its Relation with Symptom Remission.,"STUDY OBJECTIVES


Sleep schedule consistency is fundamental to cognitive behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intra-individual variability (IIV) in sleep schedule, and (2) sleep schedule IIV predicts insomnia symptom remission.
METHODS


This secondary analysis compares participants (N=303) randomized to an Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on ten online sleep diaries collected over two weeks at baseline and nine-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and six-month follow-up; symptom remission was defined by ISI<8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.
RESULTS


At post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps<.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
CONCLUSIONS


Findings demonstrate that an Internet-delivered CBT-I program can effectively increase users' sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.",2020,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
",[],"['Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE', 'Internet-Based Cognitive-Behavioral Therapy', 'SHUTi']","['daily bedtimes and rising times on ten online sleep diaries', 'insomnia symptom remission', 'rising time variability', 'Insomnia Severity Index (ISI', 'symptom remission', 'Bedtime and rising time']",[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",303.0,0.0636908,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12).
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, Department of Public Health Sciences, Chicago, IL, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Laval University, Department of Psychology, Québec, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ingersoll', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc, [department n/a], Boston, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}]",Sleep,['10.1093/sleep/zsaa115']
1107,32511749,Clinical outcomes and safety profile of Tenecteplase in wake-up stroke.,"BACKGROUND


Tenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There are lacking data about safety and efficacy of tenecteplase in wake-up stroke (WUPS).
AIMS


To investigate safety and efficacy of tenecteplase compared to alteplase in WUPS patients included in NOR-TEST.
METHODS


WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified Rankin Scale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24 hours as compared to admission NIHSS or NIHSS 0 at 24 hours.
RESULTS


Of 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these, 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, P = 0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis.
CONCLUSIONS


In WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase- or tenecteplase-treated patients. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT01949948.",2020,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"['1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients', 'WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch', 'WUPS patients included in NOR-TEST']",['intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase'],"['early neurological improvement', 'number of patients achieving a good clinical outcome', 'clinical outcomes', 'favorable functional outcome at 90 days modified RankinScale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS', 'safety and efficacy', 'ICH events or deaths', 'Neurological improvement']","[{'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1100.0,0.0389672,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"[{'ForeName': 'Hassan Khan', 'Initials': 'HK', 'LastName': 'Ahmed', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logallo', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Thomassen', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Novotny', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Mathisen', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Kurz', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}]",Acta neurologica Scandinavica,['10.1111/ane.13296']
1108,32513424,"Glutamatergic Contribution to Probabilistic Reasoning and Jumping to Conclusions in Schizophrenia: A Double-Blind, Randomized Experimental Trial.","BACKGROUND


Impaired probabilistic reasoning and the jumping-to-conclusions reasoning bias are hallmark features of schizophrenia (SCZ), yet the neuropharmacological basis of these deficits remains unclear. Here we tested the hypothesis that glutamatergic neurotransmission specifically contributes to jumping to conclusions and impaired probabilistic reasoning in SCZ.
METHODS


A total of 192 healthy participants received either NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo in a randomized, double-blind, between-subjects design. In addition, we tested 32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission. All experiments employed two versions of a probabilistic reasoning (beads) task, which required participants to either sample individual amounts of sensory information to infer correct decisions or provide explicit probability estimates for presented sensory information. Our task instantiations assessed both information sampling and explicit probability estimates in different probabilistic contexts (easy vs. difficult conditions) and changing sensory information through random transitions among easy, difficult, and ambiguous trial types.
RESULTS


Following administration of D-cycloserine, haloperidol, and bromocriptine, healthy participants displayed data-gathering behavior that was normal compared with placebo and was adequate in the context of all employed task conditions and trial level difficulties. However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information. These effects were mirrored in patients with SCZ performing the same versions of the beads task.
CONCLUSIONS


Our findings provide novel neuropharmacological evidence linking reduced glutamatergic neurotransmission to impaired information sampling and to disrupted probabilistic reasoning, namely to overweighting of sensory evidence, in patients with SCZ.",2020,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","['32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission', 'Schizophrenia', '192 healthy participants', 'healthy participants receiving', 'patients with SCZ']","['probabilistic reasoning (beads) task', 'NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo', 'D-cycloserine, haloperidol, and bromocriptine', 'dextromethorphan', 'placebo']","['data-gathering behavior', 'probability estimates, and overweighting of sensory information']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",192.0,0.404789,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany. Electronic address: wolfgang.strube@med.uni-muenchen.de.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marshall', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Quattrocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Department of Neurology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Camelia Lucia', 'Initials': 'CL', 'LastName': 'Cimpianu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ulbrich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schneider-Axmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics of the University Augsburg, Bezirkskrankenhaus Augsburg, University of Augsburg, Augsburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bestmann', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Wellcome Centre for Human Neuroimaging, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.03.018']
1109,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1110,32513312,Dietary supplementation with seed oil from transgenic  Camelina sativa  induces similar increments in plasma and erythrocyte DHA and EPA to fish oil in healthy humans.,"EPA and DHA are required for normal cell function and can also induce health benefits. Oily fish are the main source of EPA and DHA for human consumption. However, food choices and concerns about the sustainability of marine fish stocks limit the effectiveness of dietary recommendations for EPA + DHA intakes. Seed oils from transgenic plants that contain EPA + DHA are a potential alternative source of EPA and DHA. The present study investigated whether dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA was as effective as fish oil (FO) in increasing EPA and DHA concentrations when consumed as a dietary supplement in a blinded crossover study. Healthy men and women (n 31; age 53 (range 20-74) years) were randomised to consume 450 mg/d EPA + DHA provided either as either CSO or FO for 8 weeks, followed by 6 weeks washout and then switched to consuming the other test oil. Fasting venous blood samples were collected at the start and end of each supplementation period. Consuming the test oils significantly (P < 0·05) increased EPA and DHA concentrations in plasma TAG, phosphatidylcholine and cholesteryl esters. There were no significant differences between test oils in the increments of EPA and DHA. There was no significant difference between test oils in the increase in the proportion of erythrocyte EPA + DHA (CSO, 12 %; P < 0·0001 and FO, 8 %; P = 0·02). Together, these findings show that consuming CSO is as effective as FO for increasing EPA and DHA concentrations in humans.",2020,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","['healthy humans', 'Healthy men and women (n 31; age 53 (20-74) yrs']","['dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA', 'consume 450 mg/day EPA+DHA provided either as either CSO or FO']","['EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters', 'EPA and DHA', 'proportion of erythrocyte EPA+DHA', 'Fasting venous blood samples']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003069', 'cui_str': 'Transgenic Animals'}, {'cui': 'C3474157', 'cui_str': 'CAMELINA SATIVA SEED OIL'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.0929784,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","[{'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'West', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Centre for Biological Sciences, Faculty of Natural and Environmental Sciences, University of Southampton, SouthamptonSO17 1BJ, UK.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Johnathan A', 'Initials': 'JA', 'LastName': 'Napier', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002044']
1111,32513313,Dried fruit consumption and cardiometabolic health: a randomised crossover trial.,"Fruit intake is associated with lower risk of cardiometabolic diseases. However, effects of dried fruits on cardiometabolic health are not well researched. We investigated the effect of daily dried fruit consumption compared with a carbohydrate-rich snack on cardiometabolic disease risk factors in adults with increased cardiometabolic risk. A two-period randomised crossover trial was conducted in adults (n 55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup/d mixed dried fruits (plums, figs, dates and raisins) or an energy- and carbohydrate-matched control snack for 4 weeks. The primary outcome was LDL-cholesterol; secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure and vascular stiffness. Linear mixed models were used for data analysis. Lipid and lipoprotein concentrations did not differ between conditions; however, dried fruit increased LDL-cholesterol (0·10 mmol/l, 95 % CI 0·01, 0·20) compared with baseline. Compared with the control, dried fruit increased mean fasting glucose (0·08 mmol/l, 95 % CI 0·005, 0·16; P = 0·038). Vascular outcomes, fasting insulin and C-reactive protein did not differ between conditions. Mean weight changes did not differ (P = 0·55) but tended to increase after both conditions (dried fruit 0·3 kg, 95 % CI -0·09, 0·65; control 0·4 kg, 95 % CI 0·01, 0·75). Thus, short-term daily consumption of a large portion of mixed dried plums, figs, dates and raisins, without structured dietary guidance, did not improve cardiometabolic risk factors, compared with carbohydrate-rich snacks, in adults with increased baseline cardiometabolic risk.",2020,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","['adults (n=55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup', 'adults with increased cardiometabolic risk']","['dried fruits', 'daily dried fruit consumption', 'carbohydrate-rich snack', 'd mixed dried fruits (plums, figs, dates, and raisins) or a calorie- and carbohydrate-matched control snack']","['Dried fruit consumption and cardiometabolic health', 'cardiometabolic health', 'mean fasting glucose', 'Vascular outcomes, fasting insulin, and C-reactive protein', 'baseline cardiometabolic risk', 'Lipid and lipoprotein concentrations', 'Mean weight changes', 'cardiometabolic risk factors', 'low-density lipoprotein cholesterol (LDL-C); secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure, and vascular stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0916874,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","[{'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002007']
1112,32514794,"Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.","INTRODUCTION


Many commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes.
METHODS


This randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon.
RESULTS


Of the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient.
CONCLUSION


Nasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia.
TRIAL REGISTRATION


NCT03339453, ClinicalTrials.gov.",2020,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes']","['Insulin-Induced Hypoglycaemia', 'Glucagon preparations', 'Glucagon', 'Nasal glucagon', 'intramuscular glucagon (IMG', 'Nasal glucagon (NG']",['Hypoglycaemia (plasma glucose [PG'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.229767,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Suico', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': 'Endocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00845-7']
1113,32515426,The Effect of CO2 Laser Irradiation Combined with TiF4 and NaF Varnishes on Enamel Hardness: An In Vitro Study.,"PURPOSE


To assess the effects of experimental titanium tetrafluoride (TiF4) varnish and commercial sodium fluoride (NaF) varnish with CO2 laser on enamel hardness.
MATERIALS AND METHODS


Ninety human enamel samples were randomly assigned to one of the following groups: 1. control (no treatment) (CO); 2. NaF varnish (2.26%) (NF); 3. TiF4 varnish (2.45%) (TF); 4. CO2 laser (La); 5. NaF varnish (2.26%) with CO2 laser (NFL); 6. TiF4 varnish (2.45%) with CO2 laser (TFL). Enamel surface changes were determined by Vickers microhardness (VH) test with a load of 1000 g and a dwell time of 12 s. Each sample was indented three times. Data were analysed using one-way ANOVA and Tukey's test.
RESULTS


The mean surface microhardness was 245.5 VH in the CO group, 280.3 VH in group NF, 338.7 VH group TF, 277.0 VH in group La, 345.3 VH in group NFL, and 368.0 VH in group TFL. Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05).
CONCLUSION


The microhardness of enamel treated with TiF4 varnish with or without laser irradiation was statistically significantly greater than that of the control group. Thus, using TiF4 to increase enamel surface microhardness can be recommended.",2020,"Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05).
","['Enamel Hardness', 'Ninety human enamel samples']","['TiF4 varnish with or without laser irradiation', 'CO2 laser (La', 'NaF varnish', 'CO2 laser (NFL', 'TiF4 varnish', 'CO2 Laser Irradiation Combined with TiF4 and NaF Varnishes', 'CO', 'CO2 laser (TFL', 'control (no treatment', 'experimental titanium tetrafluoride (TiF4) varnish and commercial sodium fluoride (NaF) varnish with CO2 laser']",['surface hardness'],"[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0076741', 'cui_str': 'titanium tetrafluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0194982,"Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05).
","[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Dehghan', 'Affiliation': ''}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Mojarad', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Serajzadeh', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fekrazad', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44690']
1114,32686502,Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET in a randomised clinical trial.,"PURPOSE


We present a randomised clinical trial using F-PET/CT to analyse new bone metabolic mineralisation adjacent to acetabular cups following total hip arthoplasty (THA).
PATIENTS AND METHODS


THA was performed on 26 patients (26 cases) with hip OA. Patients with hip osteoarthritis (OA) were randomly assigned to operations with cemented or uncemented acetabular components. The contralateral, healthy acetabulum was used as referent for normal bone metabolism. The patients were analysed with radiography, clinical scoring, and F-PET/CT preoperatively, and at 6 weeks and 6 months postoperatively.
RESULTS


No major complications were recorded, and clinical results were good in all patients. Radiography showed all cups to be stable. The bone-forming activity, as measured by F-PET/CT, was quantified as standardised uptake values (SUV). The mean SUV was 4.6 (6 weeks) and 3.5 (6 months) around the uncemented cups, and 4.8 and 4.0, respectively, for the cemented cups. Normal healthy bone metabolism in the referent was 2.8 and 2.7 SUV at 6 weeks and 6 months, respectively.  P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
INTERPRETATION


An acetabulum affected by OA has elevated SUV activity. Both cemented and uncemented cups had elevated bone metabolic activity at 6 weeks. The raised activity was interpreted as an effect from bone mineralisation secondary to surgical trauma and healing, and to the OA. At 6 months, activity was more normalised for the uncemented group than for the cemented, suggesting healing may terminate faster in the uncemented group. Postoperative bone metabolic activity can be analysed in detail by F-PET/CT.ClinicalTrials.gov Identifier: NCT01623687.",2020,"P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
","['total hip arthoplasty (THA', '26 patients (26 cases) with hip OA', 'Patients with hip osteoarthritis (OA']","['Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET', 'Radiography', 'operations with cemented or uncemented acetabular components', 'F-PET/CT']","['elevated SUV activity', 'Normal healthy bone metabolism', 'elevated bone metabolic activity', 'Postoperative bone metabolic activity', 'activity', 'mean SUV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",26.0,0.0403775,"P  < 0.01 for the cemented group at 6 weeks and 6 months, for the uncemented group only at 6 weeks.
","[{'ForeName': 'Gösta', 'Initials': 'G', 'LastName': 'Ullmark', 'Affiliation': '¹Department of Orthopaedics, Gävle Hospital, Gävle, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sörensen', 'Affiliation': 'Department of Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Nilsson', 'Affiliation': 'Department of Orthopaedics, Uppsala University Hospital, Sweden.'}, {'ForeName': 'Enn', 'Initials': 'E', 'LastName': 'Maripuu', 'Affiliation': 'Department of Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019861274']
1115,32513836,"Multicenter Phase I Trial of a DNA Vaccine Encoding the Androgen Receptor Ligand-binding Domain (pTVG-AR, MVI-118) in Patients with Metastatic Prostate Cancer.","PURPOSE


Preclinical studies demonstrated that a DNA vaccine (pTVG-AR, MVI-118) encoding the androgen receptor ligand-binding domain (AR LBD) augmented antigen-specific CD8 +  T cells, delayed prostate cancer progression and emergence of castration-resistant disease, and prolonged survival of tumor-bearing mice. This vaccine was evaluated in a multicenter phase I trial.
PATIENTS AND METHODS


Patients with metastatic castration-sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy were randomly assigned to receive pTVG-AR on one of two treatment schedules over one year, and with or without GM-CSF as a vaccine adjuvant. Patients were followed for 18 months. Primary objectives were safety and immune response. Secondary objectives included median time to PSA progression, and 18-month PSA-PFS (PPFS).
RESULTS


Forty patients were enrolled at three centers. Twenty-seven patients completed treatment and 18 months of follow-up. Eleven patients (28%) had a PSA progression event before the 18-month time point. No grade 3 or 4 adverse events were observed. Of 30 patients with samples available for immune analysis, 14 (47%) developed Th1-type immunity to the AR LBD, as determined by IFNγ and/or granzyme B ELISPOT. Persistent IFNγ immune responses were observed irrespective of GM-CSF adjuvant. Patients who developed T-cell immunity had a significantly prolonged PPFS compared with patients without immunity (HR = 0.01; 95% CI, 0.0-0.21;  P  = 0.003).
CONCLUSIONS


pTVG-AR was safe and immunologically active in patients with mCSPC. Association between immunity and PPFS suggests that treatment may delay the time to castration resistance, consistent with preclinical findings, and will be prospectively evaluated in future trials. See related commentary by Shenderov and Antonarakis, p. 5056 .",2020,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003).
","['Patients with Metastatic Prostate Cancer', 'Patients with metastatic castration sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy', 'Forty patients were enrolled at three centers', 'patients with mCSPC']","['pTVG-AR', 'DNA', 'Vaccine Encoding the Androgen Receptor Ligand Binding Domain (pTVG-AR, MVI-118', 'DNA vaccine (pTVG-AR, MVI-118']","['safety and immune response', 'grade 3 or 4 adverse events', 'PSA progression event', 'median time to PSA progression, and 18-month PSA-progression-free survival (PPFS', 'PPFS', 'Persistent IFNγ immune responses', 'Th1-type immunity to the AR LBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",40.0,0.0764183,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003).
","[{'ForeName': 'Christos E', 'Initials': 'CE', 'LastName': 'Kyriakopoulos', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferrari', 'Affiliation': 'Department of Oncology, Albert Einstein College of Medicine, Montefiore Medical Center for Cancer Care, New York, New York.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Schweizer', 'Affiliation': 'University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Olson', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin. dm3@medicine.wisc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0945']
1116,32520346,Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study.,"BACKGROUND


Dietary Guidelines for Americans recommend the consumption of 3 servings/d of low-fat/nonfat dairy. The effects of higher dairy consumption and its fat content are unknown in patients with type 2 diabetes.
OBJECTIVE


Evaluate the impact of higher consumption of high- compared with low-fat dairy on glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors in patients with type 2 diabetes.
METHODS


We enrolled 111 subjects with type 2 diabetes (aged 58.5 ± 8.9 y, 47% females, diabetes duration 13.2 ± 8.3 y, HbA1c 8.09 ± 0.96%) who consumed <3 servings of dairy/d. We randomly assigned them into 3 groups: control group maintained baseline dairy intake, low-fat (LF) group incorporated ≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated ≥3 servings/d of HF dairy. We evaluated HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake at baseline, and after 12 and 24 wk.
RESULTS


At 24 wk, percent energy from saturated fat increased from baseline in the HF group by 3.6%, (95% CI: 2.2, 5.1) and decreased in the LF group by -1.9% (95% CI: -3.3, -0.4). The LF group increased their percent energy from protein by 4.5% (95% CI: 2.6, 6.4), whereas the HF group decreased their percent energy from carbohydrates by -3.4% (95% CI: -0.2, -6.7). There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


In patients with type 2 diabetes, increased dairy consumption to ≥3 servings/d compared with <3 servings/d, irrespective of its fat content, while maintaining energy intake has no effect on HbA1c, body weight, body composition, lipid profile, or BP. This trial was registered at clinicaltrials.gov as NCT02895867.",2020,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


","['111 subjects with type 2 diabetes (aged 58.5\xa0±\xa08.9 y, 47% females, diabetes duration 13.2\xa0±\xa08.3 y, HbA1c 8.09\xa0±\xa00.96%) who consumed\xa0<3 servings of dairy/d', 'patients with type 2 diabetes']","['dairy consumption and its fat content', 'control group maintained baseline dairy intake, low-fat (LF) group incorporated\xa0≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated\xa0≥3 servings/d of HF dairy', 'high- compared with low-fat dairy']","['glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors', 'HbA1c, body weight, body composition, lipid profile, or BP', 'glycemic control and cardiovascular disease risk factors', 'percent energy from protein', 'mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP', 'dairy consumption', 'percent energy from saturated fat', 'HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",111.0,0.0619029,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Tomah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Adham', 'Initials': 'A', 'LastName': 'Mottalib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Salsberg', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Ashrafzadeh', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pober', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Eldib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Mhd Wael', 'Initials': 'MW', 'LastName': 'Tasabehji', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa138']
1117,32515412,Are Information Technologies Capable of Stimulating the Use of Dental Floss by Adolescents? A Cluster Randomised Clinical Trial.,"PURPOSE


To analyse the effect of information technologies on improving the frequency of the use of dental floss among adolescents.
MATERIALS AND METHODS


A randomised, controlled clinical trial was conducted with 291 adolescents (mean age: 16.1 years) in three phases. Phase I involved the application of a questionnaire and clinical examinations using the simplified Oral Hygiene Index and gingival bleeding index. In phase II, the adolescents were randomly allocated to four groups: oral counseling (OR) and the use of an application (App) for smartphones; OR without the app; video (VD) and app; and VD without app. Messages were set through the app for 30 days. Phase III involved the second administration of the questionnaire and clinical examination. The frequency of dental floss use was evaluated in phases I and III. The groups were categorised into the use of technology (VD and/or App) and non-use of technology (OR alone).
RESULTS


Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001). Moreover, information technologies were associated with an improvement in the frequency of dental floss use (p < 0.033).
CONCLUSION


All methods were effective at improving clinical indicators. The use of information technologies can be considered an effective tool for improving dental floss use among adolescents.",2020,Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001).,"['291 adolescents (mean age: 16.1 years) in three phases', 'adolescents']","['technology (VD and/or App) and non-use of technology (OR alone', 'oral counseling (OR) and the use of an application (App) for smartphones; OR without the app; video (VD) and app; and VD without app']","['frequency of dental floss use', 'simplified Oral Hygiene Index and gingival bleeding index']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}]",291.0,0.0390319,Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001).,"[{'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'Luciana Reichert da Silva', 'Initials': 'LRDS', 'LastName': 'Assunção', 'Affiliation': ''}, {'ForeName': 'Geisla Mary Silva', 'Initials': 'GMS', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'Fabian Calixto', 'Initials': 'FC', 'LastName': 'Fraiz', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44684']
1118,32515413,Preoperative Mouthwash in Subjects with Different Periodontal Status: A Randomised Controlled Clinical Trial.,"PURPOSE


The effects of three preoperative mouthwashes on salivary bacterial levels were evaluated and compared between subjects with differing periodontal status.
MATERIALS AND METHODS


Based on periodontal parameters, periodontally healthy individuals (n = 60) and those with gingivitis (n = 60) and periodontitis (n = 60) were randomly assigned to a single preoperative dose of chlorhexidine (CHX), essential oils (EO), cetylpyridinium chloride (CPC) or negative control mouthwashes. Saliva samples were collected between 8:00 and 11:00 a.m., before and after a single-dose rinse with the respective mouthwash. Total bacterial load and levels of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Streptococcus oralis were determined by qPCR. Data were statistically analysed using paired t- and Student's t-tests (p < 0.05).
RESULTS


CHX, EO and CPC showed greater antimicrobial efficacy than did the negative control. CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]). CHX provided greater reductions of simultaneous levels of Pg [106326.00], Td [3335841] and Tf [61557.47] in the healthy group, as did EO in the diseased groups. CPC provided the greatest reduction [3775319.36] in the periodontitis group.
CONCLUSION


Periodontal status influenced the antimicrobial efficacy of preoperative mouthwashes. Therefore, periodontal status should be taken into consideration by clinicians. The antimicrobial efficacy differed among the agents tested. CHX and EO showed the greatest efficacy. The recognition of periodontal condition by clinicians is mandatory to select the most effective preoperative mouthwash.",2020,CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]).,"['subjects with differing periodontal status', 'periodontally healthy individuals (n = 60) and those with gingivitis (n = 60) and periodontitis (n = 60', 'Subjects with Different Periodontal Status', 'healthy group, as did EO in the diseased groups']","['chlorhexidine (CHX), essential oils (EO), cetylpyridinium chloride (CPC) or negative control mouthwashes', 'CPC', 'CHX']","['Saliva samples', 'Tannerella forsythia, Treponema denticola and Streptococcus oralis', 'salivary bacterial levels', 'antimicrobial efficacy', 'Total bacterial load and levels of Porphyromonas gingivalis']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0318174', 'cui_str': 'Streptococcus oralis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}]",60.0,0.027328,CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]).,"[{'ForeName': 'Priscila de Macedo', 'Initials': 'PM', 'LastName': 'Máximo', 'Affiliation': ''}, {'ForeName': 'Sheila Cavalca', 'Initials': 'SC', 'LastName': 'Cortelli', 'Affiliation': ''}, {'ForeName': 'Davi Romeiro', 'Initials': 'DR', 'LastName': 'Aquino', 'Affiliation': ''}, {'ForeName': 'Taís Browne', 'Initials': 'TB', 'LastName': 'de Miranda', 'Affiliation': ''}, {'ForeName': 'Fernando Oliveira', 'Initials': 'FO', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'José Roberto', 'Initials': 'JR', 'LastName': 'Cortelli', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44308']
1119,32515424,Quantitative and Qualitative Evaluation of Enamel Erosion Following Air Abrasion with Bioactive Glass 45S5.,"PURPOSE


To evaluate the effect of pre-treatment air abrasion of surfaces using bioactive glass 45S5 on the progression of erosion in bovine enamel induced by a common soft drink.
MATERIALS AND METHODS


Twelve intact bovine incisors were selected and 24 enamel samples were prepared and randomly assigned to two groups (n = 12): 1. control group, no anti-erosive treatment; 2. experimental group: samples were air abraded with bioglass 45S5 before the erosive challenge. The enamel samples were submitted to erosive cycling using a common soft drink. Enamel surface loss was evaluated using optical profilometry; surface microhardness and roughness changes were determined using Vickers method and Vertical Scanning Interferometry, respectively. In addition, SEM observations and EDS analysis were performed to detect any alterations in surface morphology and mineral content. The data were statistically analysed using one-way ANOVA and Tukey's post-hoc test at a significance level of α = 0.05.
RESULTS


The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05). However, neither group showed a statistically significant change in surface roughness (p > 0.05). After the treatments, changes in surface morphology and mineral content of enamel were observed.
CONCLUSIONS


Surface pre-treatment using air abrasion bioglass 45S5 may help prevent enamel erosion induced by excessive consumption of soft drinks. Further clinical trials are needed to confirm the effectiveness of this method and its clinical significance.",2020,"The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05).",['Twelve intact bovine incisors were selected and 24 enamel samples'],"['control group, no anti-erosive treatment; 2. experimental group: samples were air abraded with bioglass 45S5 before the erosive challenge']","['Quantitative and Qualitative Evaluation of Enamel Erosion', 'surface roughness', 'surface morphology and mineral content of enamel', 'surface microhardness', 'Enamel surface loss', 'surface loss']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1302752', 'cui_str': 'Abrasion'}, {'cui': 'C0965947', 'cui_str': 'bioactive glass 45S5'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0238772,"The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05).","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Dionysopoulos', 'Affiliation': ''}, {'ForeName': 'Kosmas', 'Initials': 'K', 'LastName': 'Tolidis', 'Affiliation': ''}, {'ForeName': 'Effrosyni', 'Initials': 'E', 'LastName': 'Tsitrou', 'Affiliation': ''}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Kouros', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Naka', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44689']
1120,32520897,"Dynamic impact of transfusion ratios on outcomes in severely injured patients: Targeted machine learning analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios randomized clinical trial.","BACKGROUND


Massive transfusion protocols to treat postinjury hemorrhage are based on predefined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury.
METHODS


The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 Level I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semiparametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different timepoints during the first 24 hours after admission.
RESULTS


In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma/PRBC and high platelet/PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% confidence interval, 1.19-5.22) during the third hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis.
CONCLUSION


Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission.
LEVEL OF EVIDENCE


Therapeutic IV.",2020,"Overall, the transfusion ratios had no significant impact on mortality over time.","['680 severely injured patients required massive transfusion', 'Severely Injured Patients', '12 level-I trauma centers in North America']",['Transfusion Ratios'],"['relative risk of achieving hemostasis', 'mortality', 'probability of hemostasis', 'actual ratios and mortality']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",680.0,0.326126,"Overall, the transfusion ratios had no significant impact on mortality over time.","[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'From the Division of Epidemiology and Biostatistics (M.N., J.C., A.H.), School of Public Health, University of California, Berkeley; Department of Anesthesia and Perioperative Care (R.P.), Department of Surgery (L.Z.K., R.C.), School of Medicine, University of California, San Francisco, California; Division of Acute Care Surgery, Department of Surgery (E.E.F.), Medical School, Center for Translational Injury Research, Department of Surgery (C.E.W., J.B.H.), Center for Translational Injury Research, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine (M.S.), Oregon Health & Science University, Portland, Oregon; and Department of Surgery, School of Medicine (M.C.), University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pirracchio', 'Affiliation': ''}, {'ForeName': 'Lucy Z', 'Initials': 'LZ', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Callcut', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002819']
1121,32513334,The effect of 12 weeks of euenergetic high-protein diet in regulating appetite and body composition of women with normal-weight obesity: a randomised controlled trial.,"Normal-weight obesity (NWO) syndrome is associated with metabolic diseases. The present study aimed to investigate the effects of 12 weeks of a high-protein (HP) v. a standard protein (SP) diet on appetite, anthropometry and body composition in NWO women. In this clinical trial, fifty NWO women were randomly allocated to HP (n 25) or SP (n 25) diet groups. Women in the HP and SP groups consumed 25 and 15 % of their total energy intake from protein for 12 weeks. Weight, fat mass (FM), lean body mass (LBM), waist circumference (WC) and appetite were evaluated at baseline and following their 3-month intervention. After 12 weeks, the LBM was higher in HP compared with no significant changes in the SP group (mean between-group difference = 1·5 kg; 95 % CI 3·1, 0·01; effect size (d) = 0·4). Furthermore, the HP group had lower FM (mean between-group difference -1·1 kg; 95 % CI 1, -3·3; d = -0·2), body fat percentage (BFP) (mean between-group difference -2 %; 95 % CI 0·7, -5·2; d = -0·3) and WC (mean between-group difference -1·4 cm; 95 % CI 0·6, -3·6; d = -0·2) at the end of the study in comparison with the SP group. In both groups, weight and appetite were unchanged over time without significant differences between groups. Twelve weeks of euenergetic diets with different dietary protein contents resulted in no significant weight loss in women with NWO. However, an HP diet significantly improved body composition (LBM, FM, BFP and WC) in this population.",2020,12 weeks of eucaloric diets with different dietary protein content resulted in no significant weight loss in women with NWO.,"['50 NWO women', 'women with NWO', 'women with Normal Weight Obesity', 'NWO women']","['HP diet', 'HP', 'SP', 'equicaloric high protein diet', 'high-protein (HP) versus a standard protein (SP) diet']","['body composition (LBM, FM, BFP, and WC', 'Normal weight obesity (NWO) syndrome', 'weight and appetite', 'weight loss', 'LBM', 'body fat percentage (BFP', 'appetite and body composition', 'FM', 'Weight, fat mass (FM), lean body mass (LBM), waist circumference (WC), and appetite']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0045933', 'cui_str': '2-benzyl-3-formylpropanoic acid'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",50.0,0.102932,12 weeks of eucaloric diets with different dietary protein content resulted in no significant weight loss in women with NWO.,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haghighat', 'Affiliation': 'Laparascopy Research Center, School of Medicine, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 61357-15794, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, 8174673441, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mahmoodi', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Majdadin', 'Initials': 'M', 'LastName': 'Rajaei', 'Affiliation': 'Department of Radiotherapy and Oncology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, 71348-14336, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 61357-15794, Iran.'}, {'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Kooti', 'Affiliation': 'Lung Diseases & Allergy Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, 13446-666147, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammdi', 'Affiliation': 'Department of Nutrition, Khalkhal University of Medical Sciences, Khalkhal, 5681761351, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA22207, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002019']
1122,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1123,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1124,32527365,Low male partner attendance after syphilis screening in pregnant women leads to worse birth outcomes: the Syphilis Treatment of Partners (STOP) randomised control trial.,"Background Maternal syphilis causes poor birth outcomes, including congenital syphilis. Testing and treatment of partners prevents reinfection, but strategies to improve partner attendance are failing. The aim of this study was to determine the effectiveness of three partner notification strategies.
METHODS


Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda, were randomised 1:1:1 to receive either notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls. The primary outcome was the proportion of partners who attended the ANC and were treated for syphilis.
RESULTS


Between 2015 and 2016, 17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study. Only 81 of 442 partners (18.3%; 23/152 (15.1%), 31/144 (21.5%) and 27/146 (18.5%) in the NS only, NS + SMS and NS + telephone call groups respectively) attended an ANC for follow-up; there were no significant differences between the groups. Twelve per cent of women attended the ANC with their male partner, and this proportion increased over time. Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001).
CONCLUSIONS


Only 18.3% of partners of pregnant women who tested positive for syphilis received treatment. Female partners of non-attendant men had worse birth outcomes. Encouraging men to accompany women to the ANC and testing both may address the urgent need to treat partners of pregnant women in sub-Saharan Africa to reduce poor fetal outcomes.",2020,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001).  ,"['17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study', 'Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda', 'Female partners of non-attendant men had worse birth outcomes', 'Low male partner attendance after syphilis screening in pregnant women', 'Results:  Between 2015 and 2016', 'pregnant women who tested positive for syphilis received treatment']","['notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls']","['proportion of partners who attended the ANC', 'adverse birth outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}]",17130.0,0.183705,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001).  ,"[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Parkes-Ratanshi', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda; and Institute of Public Health, University of Cambridge, Forvie Site, Cambridge CB2 0SR, UK; and Corresponding author. Email: rp549@medschl.cam.ac.uk.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Mbazira Kimeze', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Nakku-Joloba', 'Affiliation': 'School of Public Health, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Hamill', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Namawejje', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kiragga', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Kayogoza Byamugisha', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rompalo', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gaydos', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}]",Sexual health,['10.1071/SH19092']
1125,32532249,Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial.,"BACKGROUND


Cerebral palsy (CP), which is the leading cause of motor disability during childhood, can produce sensory and cognitive impairments at different degrees. Most recent therapeutic interventions for these patients have solely focused on upper extremities (UE), although more than 60% of these patients present lower extremities (LE) deficits. Recently, a new therapeutic concept, Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), has been proposed, involving the constant stimulation of UE and LE. Based on motor skill learning principles, HABIT-ILE is delivered in a day-camp setting, promoting voluntary movements for several hours per day during 10 consecutive week days. Interestingly, the effects of this intervention in a large scale of youngsters are yet to be observed. This is of interest due to the lack of knowledge on functional, neuroplastic and biomechanical changes in infants with bilateral CP. The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
METHODS


This international, multicentric study will include 50 pre-school children with CP from 12 to 60 months of age, comparing the effect of 50 h (2 weeks) of HABIT-ILE versus regular motor activity and/or customary rehabilitation. HABIT-ILE presents structured activities and functional tasks with continuous increase in difficulty while the child evolves. Assessments will be performed at 3 period times: baseline, two weeks later and 3 months later. The primary outcome will be the Gross Motor Function Measure 66. Secondary outcomes will include Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics.
DISCUSSION


The results of this study should highlight the impact of a motor, intensive, goal-directed therapy (HABIT-ILE) in pre-school children at a functional, neuroplastic and biomechanical level. In addition, this changes could demonstrated the impact of this intervention in the developmental curve of each child, improving functional ability, activity and participation in short-, mid- and long-term.
NAME OF THE REGISTRY


Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE).
TRIAL REGISTRATION


NCT04017871 REGISTRATION DATE: July 12, 2019.",2020,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
","['pre-school children with bilateral cerebral palsy', 'infants with bilateral CP', 'Cerebral palsy (CP', 'pre-school children at a functional, neuroplastic and biomechanical level', '50 pre-school children with CP from 12 to 60\u2009months of age, comparing the effect of 50\u2009h (2\u2009weeks) of', 'pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors', 'Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE']","['HABIT-ILE versus regular motor activity and/or customary rehabilitation', 'HABIT-ILE', 'early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE']","['lower extremities (LE) deficits', ""Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics"", 'functional ability, activity and participation in short-, mid- and long-term', 'Gross Motor Function Measure 66']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}]",,0.0546853,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors.
","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Araneda', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephane V', 'Initials': 'SV', 'LastName': 'Sizonenko', 'Affiliation': 'Division of Child Development and Growth, Department of Pediatrics, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Newman', 'Affiliation': 'Paediatric Neurology and Neurorehabilitation Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Dinomais', 'Affiliation': 'Département de Médecine Physique et de Réadaptions, CHU Angers-Capucins, Angers, France.'}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Le Gal', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ebner-Karestinos', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Paradis', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klöcker', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Saussez', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Demas', 'Affiliation': ""Laboratoire Angevin de Recherche en Ingénierie des Systèmes, Université d'Angers, Angers, France.""}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Bailly', 'Affiliation': 'Pediatric rehabilitation department, Fondation Ildys, Brest, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bouvier', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Riquelme', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Institute on Health Sciences (UINICS-Idisba), University of the Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Brochard', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Bleyenheuft', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium. yannick.bleyenheuft@uclouvain.be.'}]",BMC neurology,['10.1186/s12883-020-01820-2']
1126,32540321,Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.,"PURPOSE


Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.
PATIENTS AND METHODS


The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.
RESULTS


A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).
CONCLUSIONS


The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.",2020,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","['A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group', 'patients with HNC who had undergone microvascular reconstruction from 2008 through 2013', 'Reconstructive Head and Neck Cancer Surgery', 'patients with head and neck cancer (HNC']","['perioperative DEX', 'DEX', 'no DEX', 'Perioperative Dexamethasone', 'perioperative dexamethasone (DEX']","['overall survival rate', 'death', 'deaths', 'Charlson comorbidity index (CCI', 'advanced disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",93.0,0.0680807,"On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases.","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Kainulainen', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. Electronic address: satu.kainulainen@hus.fi.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Aro', 'Affiliation': 'Consultant, Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Koivusalo', 'Affiliation': 'Consultant and Docent, Department of Anesthesia and Intensive Care Unit, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Wilkman', 'Affiliation': 'Consultant, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Risto P', 'Initials': 'RP', 'LastName': 'Roine', 'Affiliation': 'Professor Emeritus, Department of Health and Social Management, University of Eastern Finland, Kuopio; and Professor Emeritus, Group Administration, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Aronen', 'Affiliation': 'Biostatistics Consultant, Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Törnwall', 'Affiliation': 'Docent, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lassus', 'Affiliation': 'Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.004']
1127,32542334,"A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study.","BACKGROUND


With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms.
OBJECTIVES


The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial.
METHODS


We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study.
RESULTS


Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
CONCLUSIONS


Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects.Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).",2020,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
",['adults with eye fatigue'],"['novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry', 'placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein', 'placebo']","['visuognosis persistence time', 'individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing', 'tear break-up time, average tear break-up time, and tear meniscus height', 'eye fatigue, dry eye, and macular function', 'total score of eye fatigue symptoms', 'tear secretion', 'eye fatigue and dry eye', 'retinal thickness and retinal volume', 'macular pigment optical density']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0873128', 'cui_str': 'LUTEIN ESTERS'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0008720', 'cui_str': 'Chrysanthemum'}, {'cui': 'C1088997', 'cui_str': 'Goji Berry Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0863081', 'cui_str': 'Soreness in eyes'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]",360.0,0.320918,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
","[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Aier Eye Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Vanderbilt Epidemiology Center, Division of Epidemiology, Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Chengrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Bryan Y', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'College of Biotechnology, East China University of Science and Technology, Shanghai, China.'}, {'ForeName': 'Zhensheng', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Department of Ophthalmology, Xinhua Hospital, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa139']
1128,32543706,Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients.,"Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm 3  ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm 3  ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"['High Tibial Osteotomy patients', 'patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee', '20 HTO patients']","['Recombinant human BMP6', 'RhBMP6/ABC ', 'rhBMP6/ABC', 'recombinant human BMP6 (rhBMP6', 'placebo']","['accelerated bone healing', 'clinical examination (safety) and CT and serial radiographic analyses (efficacy', 'bone healing', 'detectable anti-rhBMP6 antibodies', 'advanced bone formation and remodelling']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0302148', 'cui_str': 'Blood clot'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",20.0,0.154535,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"[{'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Chiari', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Rakov Potok, Croatia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valentinitsch', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nemecek', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Staats', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schreiner', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolb', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Department of Environmental and Occupational Health and Sports, School of Public Health, ""Andrija Stampar,"", University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zagreb, Croatia.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perForm Biologics Inc., Holliston, MA, USA.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4107']
1129,32523295,A prospective study of two methods of analgesia in shoulder arthroscopic procedures as day case surgery.,"Background & purpose


The recent advances in anaesthesia and analgesia have significantly improved the early recovery and effective post-operative pain control in day care surgery e.g. shoulder arthroscopic procedures. Adequate analgesia improves the early rehabilitation for a better outcome. We prospectively evaluated the post-operative pain relief following the two methods of analgesia i.e. regional Inter-scalene block (ISB) vs Intra-articular (IA) injection using 0.5% Chirocaine in various therapeutic arthroscopic shoulder procedures.
Methods


A prospective comparative study was performed on a group of 105 patients (ASA grade I or II) who underwent the following procedures at two different hospitals: diagnostic arthroscopy, subacromial decompression (SAD) alone, SAD in combination with mini open cuff repairs or distal clavicle excision, anterior stabilization (Bankart's repair) and inferior capsular shift. A successful Inter-scalene block (0.5% Chirocaine-30mls) preceded the general anaesthesia (Group 1-52 patients). Local intra-articular infiltration (0.5% Chirocaine - 20 mls) was given postoperatively (Group 2-53 patients). Post operatively visual analogue scores (VAS) from 0 (no pain) to 10 (severe pain) were assessed in post-anaesthesia care unit (PACU), at 4hrs, at 24hrs and at 48 h. The amount of morphine consumption for the first 2 days after surgery was recorded.
Results


Patient characteristics were similar in both groups at both the hospitals. The median postoperative pain score of VAS <3 was observed in both groups. Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals. The mean length of adequate sensory block in group 1 was significantly higher than in group 2 [20.5 h: 4.2 h] (p < 0.001). The mean analgesic (morphine) consumption was lower in Group 1 as compared to Group 2 [4.6 mg/24 h: 18.8mg/24 h](p < 0.0001). Bone shaving procedures e.g. SAD, SAD + Rotator Cuff repair, SAD + Lateral clavicular excision required significantly higher analgesia in both groups compared to the soft tissue procedures.
Conclusion


Single dose ISB provided longer and effective postoperative analgesia. The bone shaving procedures required more analgesia in IA Group as compared to ISB Group.",2020,Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals.,"['105 patients (ASA grade I or II) who underwent the following procedures at two different hospitals', 'shoulder arthroscopic procedures as day case surgery']","['Bone shaving procedures', ""diagnostic arthroscopy, subacromial decompression (SAD) alone, SAD in combination with mini open cuff repairs or distal clavicle excision, anterior stabilization (Bankart's repair) and inferior capsular shift"", 'analgesia i.e. regional Inter-scalene block (ISB) vs Intra-articular (IA) injection using 0.5% Chirocaine', 'analgesia']","['e.g. SAD, SAD\xa0+\xa0Rotator Cuff repair, SAD\xa0+\xa0Lateral clavicular excision', 'mean analgesic (morphine) consumption', 'Local intra-articular infiltration', 'effective postoperative analgesia', 'analgesia', 'median postoperative pain score of VAS <3', 'mean length of adequate sensory block', 'Post operatively visual analogue scores (VAS) from 0 (no pain) to 10 (severe pain', 'VAS scores']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0567344', 'cui_str': 'Shave excision'}, {'cui': 'C0407864', 'cui_str': 'Diagnostic arthroscopy of joint'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0473639', 'cui_str': 'Stabilization of joint by repair of capsule'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0875986', 'cui_str': 'Chirocaine'}]","[{'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",105.0,0.0307327,Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals.,"[{'ForeName': 'Ujjwal K', 'Initials': 'UK', 'LastName': 'Debnath', 'Affiliation': 'Dept of Orthopaedics, MMIMSR, Mullana, Ambala, 133107, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': ""Dept of Orthopaedics, King's Mill Hospital, Mansfield Road, Sutton-In-Ashfield, Nottinghamshire, NG17 4JL, UK.""}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Saini', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Neev', 'Initials': 'N', 'LastName': 'Trehan', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Trehan', 'Affiliation': 'Dept of Orthopaedics, Lincoln County Hospital, Greetwell Road, Lincoln, Lincolnshire, LN2 5QY, UK.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.06.008']
1130,32524948,Rapid Reduction of  Campylobacter  Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter  has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in  Campylobacter  species after azithromycin treatment, generating the hypothesis that a decrease in  Campylobacter  may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940']
1131,32525564,Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature.,"The randomized ""Testicular cancer and Aerobic and Strength Training trial"" (TAST-trial) aimed to evaluate the effect of high-intensity interval training (HIIT) on cardiorespiratory fitness during cisplatin-based chemotherapy (CBCT) for testicular cancer (TC). Here, we report on an unexpected high number of thromboembolic (TE) events among patients randomized to the intervention arm, and on a review of the literature on TE events in TC patients undergoing CBCT. Patients aged 18 to 60 years with a diagnosis of metastatic germ cell TC, planned for 3 to 4 CBCT cycles, were randomized to a 9 to 12 weeks exercise intervention, or to a single lifestyle counseling session. The exercise intervention included two weekly HIIT sessions, each with 2 to 4 intervals of 2 to 4 minutes at 85% to 95% of peak heart rate. The study was prematurely discontinued after inclusion of 19 of the planned 94 patients, with nine patients randomized to the intervention arm and 10 to the control arm. Three patients in the intervention arm developed TE complications; two with pulmonary embolism and one with myocardial infarction. All three patients had clinical stage IIA TC. No TE complications were observed among patients in the control arm. Our observations indicate that high-intensity aerobic training during CBCT might increase the risk of TE events in TC patients, leading to premature closure of the TAST-trial.",2020,No TE complications were observed among patients in the control arm.,"['Patients aged 18-60\u2009years with a diagnosis of metastatic germ cell TC, planned for 3-4 CBCT cycles', 'testicular cancer (TC', 'testicular cancer', 'TC patients undergoing CBCT']","['cisplatin-based chemotherapy (CBCT', 'exercise intervention, or to a single lifestyle counseling session', 'high-intensity interval training (HIIT', 'cisplatin-based chemotherapy']","['TE complications', 'risk of TE events', 'thromboembolic (TE) events', 'Thromboembolic events', 'cardiorespiratory fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0017471', 'cui_str': 'Germ cell'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",9.0,0.0580454,No TE complications were observed among patients in the control arm.,"[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Thorsen', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hege S', 'Initials': 'HS', 'LastName': 'Haugnes', 'Affiliation': 'Department of Oncology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Fosså', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brydøy', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Torgrim', 'Initials': 'T', 'LastName': 'Tandstad', 'Affiliation': 'Clinic of Oncology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Wisløff', 'Affiliation': 'Institute of Clinical Medicine, University of Tromsø - The Arctic University, Tromsø, Norway.'}, {'ForeName': 'Gunhild M', 'Initials': 'GM', 'LastName': 'Gjerset', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karl-Otto', 'Initials': 'KO', 'LastName': 'Larsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Sandset', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Carola E', 'Initials': 'CE', 'LastName': 'Henriksson', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Helene F S', 'Initials': 'HFS', 'LastName': 'Negaard', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33151']
1132,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1133,32542879,The Adjunctive Effect of Intravenous Magnesium Sulfate in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Clinical Trial.,,2020,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"['Chronic Obstructive Pulmonary Disease (COPD', 'Acute Exacerbation of COPD']","['Magnesium', 'Intravenous Magnesium Sulfate', 'Intravenous (IV) magnesium sulfate (MgS04']",['Acute exacerbation of COPD (AECOPD'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]",,0.0879475,It relaxes bronchial smooth muscles through its calcium channel blocking properties and inhibitory effects on the release of acetylcholine from neuromuscular junctions.,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Vafadar Moradi', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Pishbin', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Habibzadeh', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Talebi Doluee', 'Affiliation': 'From the, Faculty of Medicine, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Soltanifar', 'Affiliation': 'and the, Faculty of Medicine, Tehran University of Medical Sciences, Tahran, Iran.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14050']
1134,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
1135,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND


Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake.
OBJECTIVES


This study aimed to examine the relationship between food intake and dyadic verbal interactions.
METHODS


This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function.
RESULTS


The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
CONCLUSION


Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654']
1136,32529574,"It's not you, it's me - disgust sensitivity towards body odor in deaf and blind individuals.","Disgust might be elicited by various sensory channels, including the sense of smell. It has been previously demonstrated that unpleasant odors emitted by an external source are more disgusting than those emitted by oneself (the source effect). As disgust's main purpose is to help organisms avoid potentially dangerous, contaminating objects, individuals with visual or hearing sensory impairment (thus, with an impeded ability to detect cues indicating pathogen threat) might have developed an increased levels of olfactory disgust sensitivity (modality compensation in disgust sensitivity). We set out to investigate disgust sensitivity in olfaction using the Body Odor Disgust Scale (BODS) on a large sample of 74 deaf and 98 blind participants, with comparison to control groups without sensory impairment (N = 199 in total). The results did not support the hypothesis of modality compensation in disgust sensitivity. Contrary to previous research, neither sex nor age influenced the outcomes. Evidence for the source effect was found. Acquired data are interpreted in the light of social desirability. The emphasis put on the olfaction by blind and deaf individuals is discussed.",2020,The results did not support the hypothesis of modality compensation in disgust sensitivity.,"['large sample of 74 deaf and 98 blind participants, with comparison to control groups without sensory impairment (N = 199 in total']",[],['Body Odor Disgust Scale (BODS'],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0085595', 'cui_str': 'Body odor'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0179141,The results did not support the hypothesis of modality compensation in disgust sensitivity.,"[{'ForeName': 'Michal Mikolaj', 'Initials': 'MM', 'LastName': 'Stefanczyk', 'Affiliation': 'Institute of Psychology, University of Wroclaw, ul. Dawida 1, 50-527, Wroclaw, Poland. michal.m.stefanczyk@gmail.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oleszkiewicz', 'Affiliation': 'Institute of Psychology, University of Wroclaw, ul. Dawida 1, 50-527, Wroclaw, Poland.'}]","Attention, perception & psychophysics",['10.3758/s13414-020-02075-2']
1137,32546652,Wisdom of the expert crowd prediction of response for 3 neurology randomized trials.,"OBJECTIVE


To explore the accuracy of combined neurology expert forecasts in predicting primary endpoints for trials.
METHODS


We identified one major randomized trial each in stroke, multiple sclerosis (MS), and amyotrophic lateral sclerosis (ALS) that was closing within 6 months. After recruiting a sample of neurology experts for each disease, we elicited forecasts for the primary endpoint outcomes in the trial placebo and treatment arms. Our main outcome was the accuracy of averaged predictions, measured using ordered Brier scores. Scores were compared against an algorithm that offered noncommittal predictions.
RESULTS


Seventy-one neurology experts participated. Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090). The 95% sPIs of individual predictions contained actual trial outcomes among 44% of experts. Only 18% showed prediction skill exceeding the noncommittal prediction. Independent experts and coinvestigators achieved similar levels of accuracy.
CONCLUSION


In this first-of-kind exploratory study, averaged expert judgments rarely outperformed noncommittal forecasts. However, experts at least anticipated the possibility of effects observed in trials. Our findings, if replicated in different trial samples, caution against the reliance on simple approaches for combining expert opinion in making research and policy decisions.",2020,"Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090).",['Seventy-one neurology experts participated'],['placebo'],[],"[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.395631,"Combined forecasts of experts were less accurate than a noncommittal prediction algorithm for the stroke trial (pooled Brier score = 0.340, 95% subjective probability interval [sPI] 0.340 to 0.340 vs 0.185 for the uninformed prediction), and approximately as accurate for the MS study (pooled Brier score = 0.107, 95% confidence interval [CI] 0.081 to 0.133 vs 0.098 for the noncommittal prediction) and the ALS study (pooled Brier score = 0.090, 95% CI 0.081 to 0.185 vs 0.090).","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Atanasov', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Diamantaras', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'MacPherson', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Vinarov', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Benjamin', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Shrier', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dirnagl', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kimmelman', 'Affiliation': 'From Pytho LLC (P.A.), Brooklyn, NY; Department of Neurology (A.D.), Inselspital, Bern University Hospital, University of Bern, Switzerland; Biomedical Ethics Unit, Department of Social Studies of Medicine (A.M., E.V., D.M.B., J.K.), and Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital (I.S.), McGill University, Montreal, Canada; Max Delbrueck Center for Molecular Medicine (F.P.), Berlin; Department of Neurology (F.P.), NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité-Universitätsmedizin Berlin; Humboldt-Universität zu Berlin (U.D.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin; and Department of Experimental Neurology and Center for Stroke Research Berlin and QUEST Center for Transforming Biomedical Research (U.D.), Berlin Institute of Health, Germany. jonathan.kimmelman@mcgill.ca.'}]",Neurology,['10.1212/WNL.0000000000009819']
1138,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972']
1139,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1140,32533949,Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study.,"PURPOSE


To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
DESIGN


Phase III, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study (ClinicalTrials.govNCT02623738).
METHODS


After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI versus latanoprost was 1.5 mm Hg. Adverse events (AEs) were recorded.
RESULTS


Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients who received OMDI or latanoprost had a mean ± SD diurnal IOP of 23.78 ± 1.73 mm Hg and 23.40 ± 1.51 mm Hg, respectively. At week 4, least-squares mean ± SE reduction in IOP from baseline with OMDI (-5.93 ± 0.23 mm Hg) was noninferior to that of latanoprost (-6.56 ± 0.22 mm Hg; 95% confidence interval between groups: 0.01-1.26). The most frequently reported treatment-related ocular AEs (OMDI vs latanoprost) were conjunctival hyperemia (23/94 patients [24.5%] vs 10/96 patients [10.4%]), corneal thickening (11/94 patients [11.7%] vs 1/96 patients [1.0%]), and punctate keratitis (0/94 patients vs 5/96 patients [5.2%]). No serious AEs were observed in either group, and there were no discontinuations related to the study drug.
CONCLUSIONS


OMDI 0.002% was noninferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated.",2020,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"['190 patients randomized, 189 had at least 1 post-baseline IOP measurement', 'Primary Open-angle Glaucoma and Ocular Hypertension', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT']","['Omidenepag Isopropyl Versus Latanoprost', 'omidenepag isopropyl (OMDI', 'OMDI or latanoprost', 'OMDI 0.002% or latanoprost', 'latanoprost']","['mean diurnal IOP', 'conjunctival hyperemia ', 'serious AEs', 'corneal thickening', 'tolerated', 'punctate keratitis', 'mean diurnal IOP (±SD', 'Adverse events (AEs', 'Intraocular pressure (IOP']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C5139819', 'cui_str': 'omidenepag isopropyl'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3160915', 'cui_str': 'Corneal thickening'}, {'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}]",190.0,0.21222,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, California, USA. Electronic address: fenghe_lu@hotmail.com.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, California, USA; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.003']
1141,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND


People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown.
OBJECTIVE


To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization.
DESIGN


A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469).
METHODS


A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups.
RESULTS


Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups.
CONCLUSION


Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641']
1142,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
1143,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION


The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
METHODS


Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
RESULTS


Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
CONCLUSION


Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x']
1144,32529735,Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0688023,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16330']
1145,31611612,Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.,"BACKGROUND


Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours.
METHODS


We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials.
RESULTS


Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
CONCLUSION


SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours.
CLINICAL TRIAL REGISTRATION


NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.",2019,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","['Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals', 'patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END', 'patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END']",['elective neck dissection'],"['overall survival (OS) and disease-free survival (DFS', 'facial/neck nerve damage; QoL', 'Occult neck disease', 'risk of death/recurrence']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026640', 'cui_str': 'Neoplasm of mouth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.620858,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","[{'ForeName': 'Iain L', 'Initials': 'IL', 'LastName': 'Hutchison', 'Affiliation': 'Barts Health NHS Trust, London, UK. hutch.london@googlemail.com.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Ridout', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Sharon M Y', 'Initials': 'SMY', 'LastName': 'Cheung', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hardee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surwald', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Janavikulam', 'Initials': 'J', 'LastName': 'Thiruchelvam', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Tim K', 'Initials': 'TK', 'LastName': 'Mellor', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Brennan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldwin', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Halfpenny', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Danford', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Whitley', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Malcolm W', 'Initials': 'MW', 'LastName': 'Bailey', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woodwards', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McManners', 'Affiliation': 'NHS Forth Valley, Stirling, UK.'}, {'ForeName': 'Chi-Hwa', 'Initials': 'CH', 'LastName': 'Chan', 'Affiliation': 'Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Camilleri', 'Affiliation': 'East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Avery', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Putnam', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, Carlisle, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Smith', 'Affiliation': 'Northampton General Hospital NHS Trust, Northampton, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McVicar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grew', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hislop', 'Affiliation': 'NHS Ayrshire & Arran, Kilmarnock, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kalavrezos', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Martin', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'University College London, Cancer Research UK & UCL Cancer Trials Centre, London, UK.'}]",British journal of cancer,['10.1038/s41416-019-0587-2']
1146,32526916,Immediate Effects of Tibialis Anterior and Calf Muscle Taping on Center of Pressure Excursion in Chronic Stroke Patients: A Cross-Over Study.,"Stroke patients often have muscles spasticity, difficulty with posture control, and tend to fall. This study investigated the use of kinesiology tape for patients with spasticity of ankle muscles after stroke. This study had a randomized, repeated measures design, and evaluated the immediate effect of kinesiology tape on the center of pressure (COP) excursion when applied to the calf and tibialis anterior muscles in stroke survivors. We determined that the taping attachment direction affects the COP movement. Twenty subjects were randomly assigned to the tibialis anterior taping condition, calf taping condition, or nontaping condition. Condition excursion was assessed. The measured variables included the paretic side area, nonparetic side area, forward area, and backward area of COP. All evaluations were conducted immediately after taping. COP excursion for chronic stroke survivors improved after tibialis anterior and calf taping (p < 0.05). Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05). Kinesiology tape immediately increased the forward and backward COP excursion for patients with stroke.",2020,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","['Twenty subjects', 'patients with spasticity of ankle muscles after stroke', 'Chronic Stroke Patients', 'stroke survivors', 'patients with stroke']","['tibialis anterior taping condition, calf taping condition, or nontaping condition', 'Tibialis Anterior and Calf Muscle Taping', 'kinesiology tape']","['center of pressure (COP) excursion', 'COP excursion for chronic stroke survivors', 'forward and backward COP excursion', 'tibialis anterior taping conditions', 'Calf taping conditions', 'paretic side area, nonparetic side area, forward area, and backward area of COP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",20.0,0.0161572,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'NEULBOM Hospital 17, Poeun-daero 59 beon-gil, Suji-gu, Yongin-si, Gyeonggi-do 16864, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam 330-714, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114109']
1147,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE


Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
METHODS


In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
RESULTS


A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
CONCLUSIONS


Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
TRIAL REGISTRATION


Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012']
1148,32535135,Induction of sustained unresponsiveness after egg oral immunotherapy compared to baked egg therapy in children with egg allergy.,"BACKGROUND


While desensitization and sustained unresponsiveness (SU) have been shown with egg oral immunotherapy (OIT), the benefits of baked egg (BE) therapy for egg allergy have not been well studied.
OBJECTIVES


This study sought to evaluate the safety and efficacy of BE ingestion compared with egg OIT in participants allergic to unbaked egg but tolerant to BE.
METHODS


Children who are BE-tolerant but unbaked egg reactive ages 3 to 16 years were randomized to 2 years of treatment with either BE or egg OIT. Double-blind, placebo-controlled food challenges were conducted after 1 and 2 years of treatment to assess for desensitization, and after 2 years of treatment followed by 8 to 10 weeks off of treatment to assess for SU. Mechanistic studies were conducted to assess for immune modulation. A cohort of participants who are BE-reactive underwent egg OIT and identical double-blind, placebo-controlled food challenges as a comparator group.
RESULTS


Fifty participants (median age 7.3 years) were randomized and initiated treatment. SU was achieved in 3 of 27 participants assigned to BE (11.1%) versus 10 of 23 participants assigned to egg OIT (43.5%) (P = .009). In the BE-reactive comparator group, 7 of 39 participants (17.9%) achieved SU. More participants who are BE-tolerant withdrew from BE versus from egg OIT (29.6% vs 13%). Dosing symptom frequency in participants who are BE-tolerant was similar with BE and egg OIT, but more frequent in participants who are BE-reactive. Egg white-specific IgE, skin testing, and basophil activation decreased similarly after BE and egg OIT.
CONCLUSIONS


Among children allergic to unbaked egg but tolerant to BE, those treated with egg OIT were significantly more likely to achieve SU than were children ingesting BE.",2020,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","['BE tolerant but unbaked egg reactive children ages 3-16 years', 'participants allergic to unbaked egg but tolerant to BE', 'egg-allergic children', 'Fifty participants (median age 7.3 years']","['baked egg therapy', 'egg oral immunotherapy (OIT', 'BE or egg OIT', 'placebo-controlled food challenges (DBPCFC', 'egg OIT and identical DBPCFCs']","['SU', 'Egg white-specific IgE, skin testing and basophil activation']","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1270739', 'cui_str': 'Egg white specific immunoglobulin E'}, {'cui': 'C0037296', 'cui_str': 'Hypersensitivity skin testing'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}]",50.0,0.291217,"Egg white-specific IgE, skin testing and basophil activation decreased similarly after BE and egg OIT.
","[{'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: edwinkim@email.unc.edu.'}, {'ForeName': 'Tamara T', 'Initials': 'TT', 'LastName': 'Perry', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Rockville.'}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Berin', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'A Wesley', 'Initials': 'AW', 'LastName': 'Burks', 'Affiliation': 'Department of Medicine and Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Cho', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Henning', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Lindblad', 'Affiliation': 'Emmes, Rockville, Md.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Plaut', 'Affiliation': 'National Institutes of Health/National Institutes of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.040']
1149,32543056,Are high fresh gas flow rates necessary during the wash-in period in low-flow anesthesia?,"In low-flow anesthesia (LFA), there is a wash-in period in which usually high fresh gas flow (FGF) rates are used to achieve the required initial concentration of anesthetic agent in the alveoli. The aim of this study was to compare the efficiency, safety and the consumption of desflurane in LFA using constant FGF (1 L/min) and conventional LFA using high FGF (4 L/min) during the wash-in period. Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study. Wash-in was accomplished with 1 L/min FGF (50% O2, 50% air) and 18% desflurane in group 1; and by 4 L/min FGF (50% O2, 50% air) and 6% desflurane in group 2. Throughout the surgery, the vaporizer was adjusted to maintain 0.6 to 0.8 minimum alveolar concentration (MAC). The time required to reach 0.7 MAC was shorter in group 1 (160 seconds [135-181] vs 288 seconds [240-500], P < .001). In 6 patients in group 1 and 13 in group 2, vaporizer settings were adjusted to maintain 0.6 to 0.8 MAC (P = .048). Desflurane consumption in the first hour and total desflurane consumption were higher in group 2 (P < .001 and P = .012, respectively). The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001). It is safe, more efficient, and economical to use 1 L/min FGF during the wash-in period in LFA.",2020,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"['Eighty patients, who were scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study']","['desflurane', 'low-flow anesthesia (LFA']","['total desflurane consumption', 'efficiency of anesthesia', 'Desflurane consumption', 'efficiency, safety', 'time required to reach 0.7 MAC']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0293921,The efficiency of anesthesia in both the first hour and in total was higher in group 1 (P < .001).,"[{'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gökçe', 'Initials': 'G', 'LastName': 'Gişi', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Gözen', 'Initials': 'G', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Öksüz', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Bilal', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Ömer Faruk', 'Initials': 'ÖF', 'LastName': 'Boran', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}, {'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Çalışır', 'Affiliation': 'Department of Anesthesiology and Reanimation, School of Medicine, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}]",The Kaohsiung journal of medical sciences,['10.1002/kjm2.12251']
1150,32537853,Authors' reply re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0726803,,"[{'ForeName': 'Gourab', 'Initials': 'G', 'LastName': 'Misra', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': 'Research and Innovation, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coia', 'Affiliation': 'Maternity Unit, University Hospitals of North Midlands, Royal Stoke University Hospital, Staffordshire, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16333']
1151,32535601,Effects of Combined Physical Movement Activity and Multifaceted Cognitive Training in Older People with Mild Neurocognitive Disorder in a Rural Community: A Randomized Control Trial.,"INTRODUCTION


Cognitive deterioration in older people with mild neurocognitive disorders (mNCD) increases the risk of progress to major NCD. Health professionals worldwide are trying to find strategies for prevention. There is a limited number of studies that deal with cultural conditions in northern Thailand.
OBJECTIVES


This study aimed to investigate the effects of a combination of physical movement activity and multifaceted cognitive training on cognitive function in older people with mNCD.
METHODS


A randomized control trial involving 70 mNCD people, according to DSM-5 criteria, was conducted on an intervention group and a control group (n = 35 each). The program for the intervention group included 24 sessions (twice a week). The outcome measures on cognitive function were assessed before and after the intervention by means of composite cognitive measures for older people, i.e., the Trail-Making Test (TMT), Digit Span (DS), Verbal Fluency (VF), Word-List Learning (WLL), and Block Design (BD).
RESULTS


The combined intervention enhanced cognitive function. TMT-A was significantly improved in the intervention group. There were significant improvements in DS sequence scores, letter verbal fluency (LVF), and category verbal fluency (CVF). Comparing the groups, there were significant differences in LVF including immediate and delayed recall. BD improved significantly in the intervention group.
CONCLUSIONS


The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD. Further studies on a variation of treatments suited to cultural conditions and their effects are needed. Trials in other communities are also recommended.",2020,The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD.,"['Older People with Mild Neurocognitive Disorder in a Rural Community', 'people with mNCD', '70 mNCD people, according to DSM-5 criteria, was conducted on an intervention group and a control group (n = 35 each', 'older people with mNCD', 'older people with mild neurocognitive disorders (mNCD']","['physical movement activity and multifaceted cognitive training', 'Combined Physical Movement Activity and Multifaceted Cognitive Training']","['BD', 'composite cognitive measures for older people, i.e., the Trail-Making Test (TMT), Digit Span (DS), Verbal Fluency (VF), Word-List Learning (WLL), and Block Design (BD', 'cognitive deterioration and cognitive functional decline', 'DS sequence scores, letter verbal fluency (LVF), and category verbal fluency (CVF', 'cognitive function', 'LVF including immediate and delayed recall', 'TMT-A']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",70.0,0.0368529,The combined intervention appeared to be effective in delaying/preventing cognitive deterioration and cognitive functional decline in people with mNCD.,"[{'ForeName': 'Jiranan', 'Initials': 'J', 'LastName': 'Griffiths', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Thaikruea', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand, lakkana.t@cmu.ac.th.'}, {'ForeName': 'Nahathai', 'Initials': 'N', 'LastName': 'Wongpakaran', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Peeraya', 'Initials': 'P', 'LastName': 'Munkhetvit', 'Affiliation': 'Department of Occupational Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Kittisares', 'Affiliation': 'Sriphat Medical Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pairada', 'Initials': 'P', 'LastName': 'Varnado', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Dementia and geriatric cognitive disorders,['10.1159/000507922']
1152,32527232,Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial.,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients.
METHODS


This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events.
DISCUSSION


This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective.
TRIAL REGISTRATION


The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463. Registration was performed before recruitment was initiated.",2020,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","['Patients aged 18 to 74\u2009years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5\u2009h of their clinical onsets, are eligible for participation in this study', 'AIS patients treated with rtPA', 'multicenter trial with an estimated sample size of 306 cases, starting in January 2018', 'patients with acute ischemic stroke (AIS', 'acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE']","['glibenclamide combined with rtPA', 'Glibenclamide (US adopted name, glyburide', 'glibenclamide or placebo', 'recombinant tissue plasminogen activator (rtPA', 'glibenclamide', 'placebo']","['30-day mortality and early neurological deterioration', 'modified Rankin Scale of 0 to 2', 'safety and efficacy', 'Safety and efficacy', 'cardiac- and glucose-related serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1549653', 'cui_str': 'Adopted name'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.247589,"BACKGROUND


Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","[{'ForeName': 'Kaibin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Heyuan People's Hospital, Heyuan, China.""}, {'ForeName': 'Guangning', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Huadu district People's Hospital, Guangzhou, China.""}, {'ForeName': 'Saijun', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Wenguo', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Maoming Hospital of Traditional Chinese Medicine, Maoming, China.'}, {'ForeName': 'Guoshuai', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Haikou People's Hospital, Haikou, China.""}, {'ForeName': 'Guohu', 'Initials': 'G', 'LastName': 'Weng', 'Affiliation': 'Department of Neurology, Hainan Hospital of Traditional Chinese Medicine, Haikou, China.'}, {'ForeName': 'Pingyan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Suyue', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China. pansuyue82@126.com.'}]",BMC neurology,['10.1186/s12883-020-01823-z']
1153,32532483,Beta Testing of a Gestational Diabetes Risk Reduction Intervention for American Indian and Alaska Native Teens.,"INTRODUCTION


American Indian and Alaska Native (AIAN) girls have double the risk of obesity, pregnancy, and gestational diabetes mellitus (GDM) than the general U.S.
POPULATION


The purpose of this study was to beta test Stopping GDM (SGDM), a GDM risk reduction intervention for at-risk AIAN teens, before beginning a randomized controlled trial.
METHOD


A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program. Daughters were at risk of GDM as assessed by a BMI ≥ 85th percentile. Pre- and posttest online questionnaires evaluated the online intervention (e-book and video).
RESULTS


Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge. Daughters demonstrated an increased self-efficacy for healthy living and pregnancy planning. Satisfaction for the e-book, video, and online survey was moderately high to very high.
DISCUSSION


The SGDM intervention is feasible and acceptable in AIAN mother-daughter dyads. These findings informed the SGDM intervention and the randomized controlled trial evaluation protocol.",2020,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","['A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program', 'American Indian and Alaska Native Teens']","['SGDM intervention', 'Stopping GDM (SGDM), a GDM risk reduction intervention', 'Gestational Diabetes Risk Reduction Intervention']","['diabetes prevention, reproductive health, and GDM knowledge', 'self-efficacy']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",11.0,0.0333475,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ''}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Stotz', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Garcia-Reyes', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Charron-Prochownik', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.005']
1154,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE


Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
HYPOTHESIS


A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes.
CONCLUSION AND IMPLICATIONS


A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies.
","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851']
1155,32537643,Effects of a modestly lower carbohydrate diet in gestational diabetes: a randomized controlled trial.,"BACKGROUND


Lower carbohydrate diets have the potential to improve glycemia but may increase ketonemia in women with gestational diabetes (GDM). We hypothesized that modestly lower carbohydrate intake would not increase ketonemia.
OBJECTIVE


To compare blood ketone concentration, risk of ketonemia, and pregnancy outcomes in women with GDM randomly assigned to a lower carbohydrate diet or routine care.
METHODS


Forty-six women aged (mean ± SEM) 33.3 ± 0.6 y and prepregnancy BMI 26.8 ± 0.9 kg/m2 were randomly assigned at 28.5 ± 0.4 wk to a modestly lower carbohydrate diet (MLC, ∼135 g/d carbohydrate) or routine care (RC, ∼200 g/d) for 6 wk. Blood ketones were ascertained by finger prick test strips and 3-d food diaries were collected at baseline and end of the intervention.
RESULTS


There were no detectable differences in blood ketones between completers in the MLC group compared with the RC group (0.1 ± 0.0 compared with 0.1 ± 0.0 mmol/L, n = 33, P = 0.31, respectively), even though carbohydrate and total energy intake were significantly lower in the intervention group (carbohydrate 165 ± 7 compared with 190 ± 9 g, P = 0.04; energy 7040 ± 240 compared with 8230 ± 320 kJ, P <0.01, respectively). Only 20% of participants in the MLC group met the target intake compared with 65% in the RC group (P <0.01). There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
CONCLUSIONS


An intervention to reduce carbohydrate intake in GDM did not raise ketones to clinical significance, possibly because the target of 135 g/d was difficult to achieve in pregnancy. Feeding studies with food provision may be needed to assess the benefits and risks of low-carbohydrate diets. This trial was registered at www.anzctr.org.au as ACTRN12616000018415.",2020,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","['Forty-six women aged (mean\xa0±\xa0SEM) 33.3\xa0±\xa00.6 y and prepregnancy', 'gestational diabetes', 'women with gestational diabetes (GDM', 'women with GDM randomly assigned to a']","['MLC', 'lower carbohydrate diet or routine care', 'modestly lower carbohydrate diet']","['Blood ketones', 'blood ketones', 'blood ketone concentration, risk of ketonemia, and pregnancy outcomes', 'carbohydrate and total energy intake', 'target intake', 'birth weight, rate of large']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0427750', 'cui_str': 'Ketone concentration, test strip measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235430', 'cui_str': 'Ketonemia'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",46.0,0.19441,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","[{'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Mijatovic', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jimmy Chun Yu', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Marion E C', 'Initials': 'MEC', 'LastName': 'Buso', 'Affiliation': 'Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Atkinson', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Glynis P', 'Initials': 'GP', 'LastName': 'Ross', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa137']
1156,32546554,A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113).,"BACKGROUND


Uterine sarcomas are a group of rare tumors that include different subtypes. Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis. We aim to explore the most appropriate management in patients with uterine high-grade sarcomas.
PRIMARY OBJECTIVE


To assess the efficacy of maintenance treatment with cabozantinib in patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy.
STUDY HYPOTHESIS


Maintenance treatment with cabozantinib after standard chemotherapy given as an adjuvant treatment after curative surgery, or in locally advanced or metastatic disease, increases progression-free survival compared with placebo TRIAL DESIGN: This is a randomized double blinded phase II trial.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study is enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with doxorubicin ± ifosfamide, who are assigned 1:1 to 60 mg daily cabozantinib (experimental arm) or placebo (control arm), as maintenance therapy. Exclusion criteria include low-grade sarcoma.
PRIMARY ENDPOINT


Progression-free survival at 4 months.
SAMPLE SIZE


The study plans to enroll 90 patients to allow the randomization of 54 patients to detect an improvement in 4-month progression-free survival from 50% to 80% with 15% significance level and 85% power. Estimated dates for accrual completion: recruitment for the trial started in February 2015, and has currently enrolled 83 patients, of whom 35 patients have been randomized. The end of recruitment is anticipated for December 2020.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov, number NCT01979393.",2020,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","['patients with uterine high-grade sarcomas', 'enrolling adult patients with high-grade undifferentiated uterine sarcomas, high-grade endometrial stromal sarcomas, high-grade leiomyosarcoma, and high-grade adenosarcoma, FIGO (Federation International gynecologue Obstétricien) stage II/III to IV in stable disease or who achieved complete or partial response with', '83 patients, of whom 35 patients have been randomized', 'Patients with histopathological high-grade diseases', 'patients with high-grade uterine sarcomas who achieved clinical benefit after standard chemotherapy']","['cabozantinib after standard chemotherapy', 'cabozantinib (experimental arm) or placebo', 'cabozantinib', 'doxorubicin ± ifosfamide']","['Progression-free survival at 4 months', '4-month progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2239246', 'cui_str': 'Endometrial stromal sarcoma, high grade'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0001442', 'cui_str': 'Adenosarcoma'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0338113', 'cui_str': 'Sarcoma of uterus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",83.0,0.477096,"Patients with histopathological high-grade diseases are at high-risk of recurrence or progression, and have a poor prognosis.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Leon Berard, Lyon, Rhône-Alpes, France isabelle.ray-coquard@lyon.unicancer.fr.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hatcher', 'Affiliation': 'medical oncology, Cambridge University, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': 'Medical Oncology Department, ICO, Saint Herblain, Pays de la Loire, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casado', 'Affiliation': 'Medical Oncology Department, Complutense University of Madrid, Madrid, Comunidad de Madrid, Spain.'}, {'ForeName': 'Annekke', 'Initials': 'A', 'LastName': 'Westermann', 'Affiliation': 'Medical Oncology Department, Academisch Medisch Centrum, Amsterdam, North Holland, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Medical Oncology Department, IRCCS, Milano, Lombardia, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pratap', 'Affiliation': 'Medical Oncology Department, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stark', 'Affiliation': 'Medical Oncology Department, Leeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valverde', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Medical Oncology Department, Nottingham Trent University, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Huizing', 'Affiliation': 'Medical Oncology Department, Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Medical Oncology Department, Institut Bergonié, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lindner', 'Affiliation': 'Medical Oncology Department, Ludwig-Maximilians-Universitat Munchen, Munchen, Bayern, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Medical Oncology Department, Eberhard Karls Universitat Tubingen, Tubingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Seddon', 'Affiliation': 'Medical Oncology Department, University College London, London, London, UK.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'Statistics and Quality of Life, EORTC, Brussels, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Medical Oncology, Royal Marsden Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Medical Oncology, NHS Greater Glasgow and Clyde, Glasgow, Glasgow, UK.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001519']
1157,32548619,"Sublobar resection versus lobectomy for patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708, SURPRISE).","The standard treatment for the patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy. However, if patients have idiopathic pulmonary fibrosis combined with early stage lung cancer, there is no standard treatment for this population. Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function; thus, the preservation of respiratory function is essential. The aim of this trial is to confirm the clinical effectiveness of sublobar resection such as wedge resection or segmentectomy for early NSCLC with idiopathic pulmonary fibrosis compared with lobectomy in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis. A planned total 430 patients will be enrolled from 50 institutions over 5 years. This trial has been registered in the UMIN Clinical Trials Registry with code UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm].",2020,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","['patients have idiopathic pulmonary fibrosis combined with early stage lung cancer', 'A planned total 430 patients will be enrolled from 50 institutions over 5\xa0years', 'Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function', 'patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy', 'early NSCLC with idiopathic pulmonary fibrosis', 'patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis']","['Sublobar resection versus lobectomy', 'sublobar resection such as wedge resection or segmentectomy']",['overall survival'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",430.0,0.0933941,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","[{'ForeName': 'Kiyo', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsutani', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiju', 'Initials': 'K', 'LastName': 'Aokage', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Saji', 'Affiliation': 'Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Watanabe', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa092']
1158,32548966,Does eating in the absence of hunger extend to healthy snacks in children?,"OBJECTIVES


To assess if eating in the absence of hunger (EAH) extends to healthier snacks and examine the relationship between the home food environment and EAH in children with normal weight (NW) or overweight/obesity (OB) who are at low risk (LR) or high risk (HR) for obesity based on maternal obesity.
METHODS


EAH was assessed after lunch and dinner when children received either low energy dense fruit snacks or high energy dense sweet/savoury snacks. The availability of obesogenic foods in the home was assessed by the Home Food Inventory.
RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001). EAH was significantly greater in HR-OB (284±8 kcal) than LR-NW (249±9 kcal) or HR-NW (251±8 kcal) children. Serving fruit rather than sweet/savoury snacks reduced energy intake, on average, by 60% (223 kcal) across risk groups. For each unit increase in the obesogenic home food environment, EAH of sweet/savoury snacks decreased by 1.83 calories.
CONCLUSIONS


Offering low energy dense snacks after a meal can moderate EAH and increase children's intake of healthy foods. Increased access to obesogenic foods in the home may reduce the salience of high energy dense snacks when they become available in other settings.",2020,"RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001).",['children with normal weight (NW) or overweight/obesity (OB) who are at low risk (LR) or high risk (HR) for obesity based on maternal obesity'],"['low energy dense fruit snacks or high energy dense sweet/savoury snacks', 'Serving fruit rather than sweet/savoury snacks']","['energy intake', 'EAH', 'HR-OB', 'obesogenic home food environment, EAH of sweet/savoury snacks']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",,0.0581201,"RESULTS


Data showed significant main effects of risk group (P=.0003) and snack type (P < .001).","[{'ForeName': 'Tanja V E', 'Initials': 'TVE', 'LastName': 'Kral', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}]",Pediatric obesity,['10.1111/ijpo.12659']
1159,32544925,Selective kappa-opioid antagonism ameliorates anhedonic behavior: evidence from the Fast-fail Trial in Mood and Anxiety Spectrum Disorders (FAST-MAS).,"Anhedonia remains a major clinical issue for which there is few effective interventions. Untreated or poorly controlled anhedonia has been linked to worse disease course and increased suicidal behavior across disorders. Taking a proof-of-mechanism approach under the auspices of the National Institute of Mental Health FAST-FAIL initiative, we were the first to show that, in a transdiagnostic sample screened for elevated self-reported anhedonia, 8 weeks of treatment with a kappa-opioid receptor (KOR) antagonist resulted in significantly higher reward-related activation in one of the core hubs of the brain reward system (the ventral striatum), better reward learning in the Probabilistic Reward Task (PRT), and lower anhedonic symptoms, relative to 8 weeks of placebo. Here, we performed secondary analyses of the PRT data to investigate the putative effects of KOR antagonism on anhedonic behavior with more precision by using trial-level model-based Bayesian computational modeling and probability analyses. We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback). Collectively, these findings provide novel evidence that in a transdiagnostic sample characterized by elevated anhedonia, KOR antagonism improved the ability to modulate behavior as a function of prior rewards. Together with confirmation of target engagement in the primary report (Krystal et al., Nat Med, 2020), the current findings suggest that further transdiagnostic investigation of KOR antagonism for anhedonia is warranted.",2020,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).",[],"['placebo, KOR antagonism', 'KOR antagonism', 'placebo']","['learning rate (i.e., ability to learn from reward feedback']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0633681,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA. dap@mclean.harvard.edu.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0738-4']
1160,32545534,"Self-Regulation in Children with Neurodevelopmental Disorders ""SR-MRehab: Un Colegio Emocionante"": A Protocol Study.","Self-regulation refers to the ability to control and modulate behavior, and it can include both emotional and cognitive modulation. Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years of age with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of ""SR-MRehab: Un colegio emocionante"", based on a non-immersive virtual reality system where virtual objects can be managed by children in a natural way using their hands. Children will be recruited from several schools of Granada (Spain) and they will be randomly allocated to two groups. An assessment will be conducted before and after the intervention and 24 weeks after the end of the intervention process. The experimental group will receive the intervention using virtual reality. The control group will receive a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated. The results will be published and will provide evidence regarding the use of this type of intervention in children with neurodevelopmental disorders. Trial registration: Registered with code NCT04418921.",2020,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","['children with neurodevelopmental disorders', 'Children with neurodevelopmental disorders', 'children between 6 and 11 years of age with neurodevelopmental disorders', 'Children with Neurodevelopmental Disorders', 'Children will be recruited from several schools of Granada (Spain']","['standard self-regulation program', 'SR-MRehab', 'Methodology']",['self-regulation skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0449342,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","[{'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Romero-Ayuso', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alcántara-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Almenara-García', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nuñez-Camarero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José Matías', 'Initials': 'JM', 'LastName': 'Triviño-Juárez', 'Affiliation': 'Primary Care Center Zaidín Sur, Granada Metropolitan Sanitary District, 18007 Granada, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Ariza-Vega', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José-Pascual', 'Initials': 'JP', 'LastName': 'Molina', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124198']
1161,32545539,"Identifying Social Network Conditions that Facilitate Sedentary Behavior Change: The Benefit of Being a ""Bridge"" in a Group-based Intervention.","Using data from one of the first trials to try to leverage social networks as a mechanism for obesity intervention, we examined which social network conditions amplified behavior change. Data were collected as part of a community-based healthy lifestyle intervention in Nashville, USA, between June 2014 and July 2017. Adults randomized to the intervention arm were assigned to a small group of 10 participants that met in person for 12 weekly sessions. Intervention small group social networks were measured three times; sedentary behavior was measured by accelerometry at baseline and 12 months. Multivariate hidden Markov models classified people into distinct social network trajectories over time, based on the structure of the emergent network and where the individual was embedded. A multilevel regression analysis assessed the relationship between network trajectory and sedentary behavior (N = 261). Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04]. Certain social network conditions may make it easier to reduce adult sedentary behavior in group-based interventions. While further research will be necessary to establish causality, the implications for intervention design are discussed.",2020,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].",[],[],[],[],[],[],,0.0215047,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].","[{'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'de la Haye', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA 90007, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Santiago J', 'Initials': 'SJ', 'LastName': 'Saldana', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124197']
1162,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE


Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration.
METHODS


Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period.
RESULTS


A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
CONCLUSIONS


Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence.
","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212']
1163,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1164,32552153,"Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials.","OBJECTIVES


The fixed-dose combination of empagliflozin and linagliptin, two glucose-lowering drugs prescribed for type 2 diabetes mellitus, has demonstrated good tolerability in phase III clinical trials. To further evaluate the safety profile of this combination, the data from these trials were pooled and analyzed.
METHODS


This was a post-hoc pooled analysis of five randomized, double-blind, clinical trials of the empagliflozin/linagliptin fixed-dose combination. Data for adverse events and laboratory parameters were evaluated.
RESULTS


The analysis included 2895 patients: 1410, 1015, and 470 receiving the empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy, respectively. Overall, the incidence of adverse events with the empagliflozin/linagliptin combination was similar to that with empagliflozin or linagliptin alone. Fewer than 2% of patients experienced hypoglycemia, and its incidence was similar across treatment groups. Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%). No cases of Fournier's gangrene, diabetic ketoacidosis, or pemphigoid occurred, and no clinically relevant mean changes in laboratory parameters were noted.
CONCLUSION


The safety profile of the fixed-dose combination of empagliflozin and linagliptin was similar to the individual monotherapies. No new safety signals were identified.",2020,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus', '2895 patients: 1410, 1015, and 470 receiving the']","['empagliflozin monotherapy', 'empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy', 'empagliflozin', 'empagliflozin and linagliptin', 'empagliflozin and linagliptin, two glucose-lowering drugs', 'empagliflozin/linagliptin', 'linagliptin monotherapy', 'empagliflozin and linagliptin combination therapy', 'empagliflozin/linagliptin fixed-dose combination', 'linagliptin']","['Safety and tolerability', 'hypoglycemia', ""Fournier's gangrene, diabetic ketoacidosis, or pemphigoid"", 'Genital infections', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017086', 'cui_str': 'Gangrene'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2895.0,0.279202,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine , Tokyo, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Diabetes and Metabolic Disease, Graduate School of Medicine, Tokyo University , Tokyo, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Yamamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': 'Biostatistics & Data Science, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Yarush', 'Affiliation': 'Global Pharmacovigilance, Boehringer Ingelheim Pharmaceuticals, Inc ., Ridgefield, CT, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Heilmann', 'Affiliation': 'Global Medical Affairs, Boehringer Ingelheim International GmbH , Ingelheim, Germany.'}, {'ForeName': 'Atsutaka', 'Initials': 'A', 'LastName': 'Yasui', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}]",Expert opinion on drug safety,['10.1080/14740338.2020.1782884']
1165,32552207,"Re: Long-Term Oncological Outcomes from an Early Phase Randomised Controlled Three-Arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).",,2020,,[],"['Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL']",[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]",[],,0.0947995,,"[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cadeddu', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001166']
1166,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND


The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS


STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION


The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029']
1167,32558330,Associations of telomere length with two dietary quality indices after a lifestyle intervention in children with abdominal obesity: a randomized controlled trial.,"BACKGROUND


Dietary factors seem to influence telomere length. Moreover, associations between changes in adiposity indices and telomere length (TL) have been found in intervention studies.
OBJECTIVE


We evaluated changes in two diet quality indices and their association with TL in children with abdominal obesity in a 12-month lifestyle intervention.
METHODS


Eighty-seven participants (7-16 years old) were assigned to the intervention (moderate hypocaloric Mediterranean diet) or usual care group (standard paediatric recommendations) for a 2-month intensive phase and a subsequent 10-month follow-up. Diet quality was assessed using the Diet Quality Index for Adolescents (DQI-A) and the Healthy Lifestyle Diet Index (HLD-I). TL was measured by monochrome multiplex real-time quantitative PCR. The intra-class correlation coefficient for TL was 0.793 (95% CI 0.707, 0.857).
RESULTS


After a 12-month lifestyle intervention, a significant reduction in BMI-SDS (-0.57 and -0.49 for the intervention and usual care groups, respectively) and fat mass was observed in all subjects without differences between groups. Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months. Interestingly, we observed a positive change in TL between 2 and 12 months (P = .025), which was associated with higher scores on the DQI-A (β = 0.008, R 2  = 0.088, P = .010) and HLD-I (β = 0.022, R 2  = 0.198, P = .015), in the intervention group after the 2-month intensive phase.
CONCLUSION


Favourable changes in diet quality indices could contribute to telomere integrity in children with abdominal obesity enrolled in an intensive lifestyle intervention.",2020,"Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months.","['children with abdominal obesity in a 12-month lifestyle intervention', 'Eighty-seven participants (7-16\u2009years old', 'children with abdominal obesity', 'children with abdominal obesity enrolled in an intensive lifestyle intervention']","['intervention (moderate hypocaloric Mediterranean diet) or usual care group (standard paediatric recommendations', 'lifestyle intervention']","['Changes in DQI-A', 'Diet quality', 'BMI-SDS', 'Diet Quality Index for Adolescents (DQI-A) and the Healthy Lifestyle Diet Index (HLD-I', 'fat mass', 'TL', 'adiposity indices and telomere length (TL', 'positive change in TL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",87.0,0.0350398,"Changes in DQI-A (+12.36% vs +5.53%, P = .005) and HLD-I (+4.43 vs +1.09, P < .001) were higher in the intervention subjects compared with usual care subjects after 2 months.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ojeda-Rodríguez', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Morell-Azanza', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Zalba', 'Affiliation': 'IdiSNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Zazpe', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Azcona-Sanjulian', 'Affiliation': 'IdiSNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Marti', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, Pamplona, Spain.'}]",Pediatric obesity,['10.1111/ijpo.12661']
1168,32556249,Psychosocial Mechanisms of Cognitive-Behavioral-Based Physical Therapy Outcomes After Spine Surgery: Preliminary Findings From Mediation Analyses.,"OBJECTIVE


Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery.
METHODS


In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months.
RESULTS


Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]).
CONCLUSIONS


This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism.
IMPACT


Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs.",2020,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","['86 participants', 'patients with a high psychosocial risk profile', 'After Spine Surgery']","['Physical Therapy (CBPT', 'Cognitive-Behavioral-Based Physical Therapy Outcomes', 'CBPT', 'postoperative CBPT', 'education program']","['back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (SF-12), fear of movement (Tampa Scale of Kinesiophobia', 'fear of movement and pain self-efficacy mediated postoperative outcomes', 'pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire', 'pain self-efficacy', 'physical health', 'fear of movement, pain catastrophizing, and pain self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}]",86.0,0.044694,"[95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5","[{'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Department of Physical Medicine and Rehabilitation, and Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopaedic Surgery, and Center for Musculoskeletal Research, Vanderbilt University Medical Center.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Vanston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Phillips', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mathis', 'Affiliation': 'Department of Kinesiology, University of Alabama, Huntsville, Alabama.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McGirt', 'Affiliation': 'Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Spengler', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, Nashville, Tennessee.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati School of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center; and Steamboat Orthopaedic and Spine Institute, Steamboat Springs, Colorado.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, 1215 21st Avenue S, Medical Center East - South Tower, Suite 4200, Nashville, TN 37232 (USA); Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa112']
1169,32557665,Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study.,"We describe outcomes from the first-in-human study of garetosmab (a fully human monoclonal antibody that inhibits activin A) under development for the treatment of fibrodysplasia ossificans progressiva (FOP). In a double-blind, placebo-controlled phase 1 study, 40 healthy women of nonchildbearing potential were randomized to receive a single dose of intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo. Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies were measured predose and up to 113 days post-first dose. Garetosmab demonstrated an acceptable safety profile with no dose-limiting toxicities. Garetosmab displayed nonlinear pharmacokinetics with target-mediated elimination. With increasing doses of intravenous garetosmab, mean peak concentration increased in a dose-proportional manner; mean steady-state estimates ranged from 41.4 to 47.8 mL/kg. A greater than dose-proportional increase in mean area under the concentration-time curve from time zero extrapolated to infinity (range, 72.2-7520 mg*day/L) was observed, consistent with decreasing mean clearance (range, 4.35-1.34 mL/day/kg). Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner. At 10 mg/kg, total activin A levels reached a state of little or no change between weeks 4 and 12, suggesting saturation of the target-mediated pathway. No safety signals were seen in this study to preclude investigation in patients. Following intravenous administration, garetosmab concentrations decreased quickly, then decreased over time (reflecting linear elimination), and finally decreased in a nonlinear phase, reflecting target-mediated elimination. Results here support further investigation. Garetosmab 10 mg/kg every 4 weeks intravenously is being evaluated in patients with FOP (NCT03188666).",2020,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.",['40 healthy women of nonchildbearing potential'],"['placebo', 'intravenous garetosmab 0.3, 1, 3, or 10 mg/kg; subcutaneous garetosmab 300 mg; or placebo', 'Garetosmab (Anti-Activin A']","['mean concentrations of total activin A', 'total activin', 'mean peak concentration', 'Serum concentrations of functional garetosmab (with ≥1 arm free to bind to target), total activin A, and antidrug antibodies', 'mean clearance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0100748', 'cui_str': 'Activin A'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",40.0,0.164094,"Following administration of intravenous garetosmab, mean concentrations of total activin A increased in a dose-dependent manner.","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Clinical Pharmacology Unit, Antwerp, Belgium.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Tiera', 'Initials': 'T', 'LastName': 'Drewery', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'DelGizzi', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Forleo-Neto', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Herman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1638']
1170,32553596,Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.,"BACKGROUND


Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking.
METHODS


COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up.
RESULTS


Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed.
CONCLUSIONS


IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.",2020,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","['patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI', 'Between November 2007 and July 2012, we enrolled 38 patients in our study', 'Males were 89% and the median age was 50.5\u202fyears']","['CD133+ BMSC', 'CD133+ cells', 'CD133+ enriched hematopoietic BMSC', 'intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC', 'placebo']","['survival rate', 'Baseline left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",38.0,0.324342,"IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haddad', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Brian James', 'Initials': 'BJ', 'LastName': 'Potter', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Matteau', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Reeves', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Leclerc', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Rivard', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Gobeil', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Denis-Claude', 'Initials': 'DC', 'LastName': 'Roy', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Hôpital Maisonneuve-Rosemont, Montréal, Québec, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada.""}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada; Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montréal, Québec, Canada. Electronic address: s.mansour@umontreal.ca.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.004']
1171,32553717,Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.,"OBJECTIVES


The aim was to fully characterize the plasma and urine washout pharmacokinetics of tenofovir (TFV) in adults following 6 weeks of controlled levels of tenofovir disoproxil fumarate (TDF) adherence, in order to inform the utility of clinic-based adherence testing.
DESIGN


This was a three-arm, randomized, open-label study in adult volunteers. Participants were randomized to receive TDF 300 mg/emtricitabine (FTC) 200 mg as (1) 7 doses/week (perfect adherence), (2) 4 doses/week (moderate adherence), or (3) 2 doses/week (low adherence). Plasma and urine samples were collected regularly during the 6-week dosing phase and for 4 weeks following drug cessation.
RESULTS


Twenty-eight adults were included in this analysis. Median (range) age was 33 (20-49) years. No differences in TFV pharmacokinetic parameters during the washout were observed across the study arms. Small differences in TFV plasma concentrations occurred across arms between 4 and 10 h post-dose. The cumulative amount of TFV excreted in urine was not different at 24 h post-dose, but at 148 h it was 24.8 mg, 21.0 mg, and 17.2 mg for the perfect, moderate, and low adherence arms, respectively (p = 0.043).
CONCLUSIONS


Among adults with different TDF adherence patterns, relative differences in plasma concentrations and cumulative urine extraction of TFV were minor following cessation. TFV measurement in plasma or urine is more indicative of last drug ingestion, rather than prior dose patterns.",2020,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","['Adults with Controlled Levels of Adherence to', 'adult volunteers', 'adults with different TDF adherence patterns', 'Median (range) age was 33 (20-49) years', 'Twenty-eight adults']","['Tenofovir Disoproxil Fumarate', 'TDF 300\u2009mg/emtricitabine (FTC']","['Plasma and urine samples', 'cumulative amount of TFV excreted in urine', 'TFV PK parameters', 'Plasma Pharmacokinetics and Urinary Excretion of Tenofovir', 'plasma concentrations and cumulative urine extraction of TFV', 'TFV measurement in plasma or urine', 'TFV plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",28.0,0.0747984,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","[{'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology and Infectious Diseases, Boston, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: tim.cressey@phpt.org.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Yardpiroon', 'Initials': 'Y', 'LastName': 'Tawon', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.037']
1172,32554770,Comorbidity is associated with disease activity in MS: Findings from the CombiRx trial.,"OBJECTIVE


To determine whether comorbidity is associated with clinical (relapses, disability worsening) and MRI outcomes in multiple sclerosis (MS) by conducting a secondary analysis of the CombiRx clinical trial.
METHODS


CombiRx compared interferon beta-1a, glatiramer acetate, and the combination of these agents. For participants eligible for evaluation of 6-month confirmed disability worsening, we used medical history, concomitant medications, and adverse events to ascertain comorbidity status. Comorbid conditions evaluated included hypertension, dyslipidemia, diabetes mellitus, depression, anxiety disorders, and migraine. Clinical outcomes included disease activity consisting of protocol-defined relapses, disability worsening, and MRI activity. We summarized the prevalence of these comorbid conditions and their association with disease activity and its components using multivariable Cox regression.
RESULTS


Of the 1,008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup, the median length of follow-up was 3.4 years (range 0.5-6.9 years). Overall, 55.1% of participants had ≥1 comorbidity at enrollment. After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01-1.55) and dyslipidemia (HR 1.32, 95% CI 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67-0.97) was associated with a decreased hazard.
CONCLUSIONS


In this large trial population with rigorously obtained outcomes, comorbid conditions were common among participants and influenced disease outcomes, including relapses. The comorbidity burden of clinical trial participants with MS may be an important factor in the outcome of clinical trials. Additional investigations of the impact of comorbidity on clinical trial outcomes and response to disease-modifying therapies are warranted.",2020,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","['1008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup the median length of follow-up was 3.4 years (range 0.5-6.9 years', 'multiple sclerosis (MS']","['interferon-beta-1a, glatiramer acetate']","['disease activity consisting of protocol-defined relapses, disability worsening and MRI activity', 'hypertension, dyslipidemia, diabetes, depression, anxiety disorders, and migraine', 'dyslipidemia', 'hazard of any disease activity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]",1008.0,0.179747,"After adjustment, anxiety (hazard ratio [HR]: 1.25; 95%CI: 1.01-1.55), and dyslipidemia (HR 1.32; 95%CI: 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80;","[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'From the Department of Biostatistics (A.S.), Washington University in St. Louis, MO; College of Pharmacy (K.K.), and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Solna, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Biostatistics (G.C.), University of Alabama in Birmingham School of Public Health. amber@wustl.edu.'}, {'ForeName': 'Kaarina', 'Initials': 'K', 'LastName': 'Kowalec', 'Affiliation': 'From the Department of Biostatistics (A.S.), Washington University in St. Louis, MO; College of Pharmacy (K.K.), and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Solna, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Biostatistics (G.C.), University of Alabama in Birmingham School of Public Health.'}, {'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'From the Department of Biostatistics (A.S.), Washington University in St. Louis, MO; College of Pharmacy (K.K.), and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Solna, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Biostatistics (G.C.), University of Alabama in Birmingham School of Public Health.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'From the Department of Biostatistics (A.S.), Washington University in St. Louis, MO; College of Pharmacy (K.K.), and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Solna, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Biostatistics (G.C.), University of Alabama in Birmingham School of Public Health.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Marrie', 'Affiliation': 'From the Department of Biostatistics (A.S.), Washington University in St. Louis, MO; College of Pharmacy (K.K.), and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Solna, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Department of Biostatistics (G.C.), University of Alabama in Birmingham School of Public Health.'}]",Neurology,['10.1212/WNL.0000000000010024']
1173,32556960,Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.,"BACKGROUND


To evaluate the efficacy of adjuvant systemic corticosteroids in reducing kidney scarring. A previous study suggested that use of adjuvant systemic corticosteroids reduces kidney scarring in children radiologically confirmed to have extensive pyelonephritis. Efficacy of corticosteroids for children with febrile urinary tract infection (UTI) has not been studied.
METHODS


Children aged 2 months to 6 years with their first febrile UTI were randomized to corticosteroids or placebo for 3 days (both arms received antimicrobial therapy); kidney scarring was assessed using  99m Tc-dimercaptosuccinic acid kidney scan 5-24 months after the initial UTI.
RESULTS


We randomized 546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned). Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
CONCLUSION


While children randomized to adjuvant corticosteroids tended to develop fewer kidney scars than children who were randomized to receive placebo, a statistically significant difference was not achieved. However, the study was limited by not reaching its intended sample size.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov , NCT01391793, Registered 7/12/2011 Graphical abstract.",2020,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","['children with febrile urinary tract infection (UTI', 'Children aged 2\xa0months to 6\xa0years with their first febrile UTI', 'children with a febrile urinary tract infection', '546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned']","['adjuvant systemic corticosteroids', 'corticosteroids or placebo', 'corticosteroids', 'Corticosteroids', 'antimicrobial therapy); kidney scarring was assessed using  99m', 'placebo']","['kidney scarring', 'kidney scars', 'Rates of kidney scarring']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0412412', 'cui_str': 'Kidney imaging with function study'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}]","[{'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",546.0,0.616011,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. nader.shaikh@chp.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Shope', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Hoberman', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Gysella B', 'Initials': 'GB', 'LastName': 'Muniz', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nowalk', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hickey', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Marian G', 'Initials': 'MG', 'LastName': 'Michaels', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kearney', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Howard E', 'Initials': 'HE', 'LastName': 'Rockette', 'Affiliation': 'Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Charron', 'Affiliation': 'Department of Radiology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Eglal', 'Initials': 'E', 'LastName': 'Shalaby-Rana', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Kurs-Lasky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Wald', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Lockhart', 'Affiliation': ""Hasbro Children's Hospital, Alpert Medical School, Providence, RI, USA.""}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'Pohl', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04622-3']
1174,32557872,"L-Carnitine metabolism, protein turnover and energy expenditure in supplemented and exercised Labrador Retrievers.","L-Carnitine is critical for protection against bioaccumulation, long-chain fatty acid transportation and energy production. Energy production becomes important as the body maintains lean mass, repairs muscles and recovers from oxidative stress. The aim was to investigate the effects of supplemented L-carnitine on protein turnover (PT), energy expenditure (EE) and carnitine metabolism in muscle/serum of Labrador Retrievers. In a series of experiments, all dogs were fed a low-carnitine diet and sorted into one of two groups: L-carnitine (LC) supplemented daily with 125 mg L-carnitine and 3.75 g sucrose or placebo (P) supplemented with 4 g sucrose daily. The experiments consisted of analyses of muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3). EXP1: 20 Labradors (10 M/10 F) performed a 13 week running regimen. L-Carnitine content was analysed in the serum and biceps femoris muscle before/after a 24.1 km run. LC serum had higher total (p < .001; p = .001), free (p < .001; p = .001) and esterified (p = .001; p = .003) L-carnitine pre- and post-run respectively. LC muscle had significantly higher free L-carnitine post-run (p = .034). EXP2: 26 Labs (13 M/13 F) performed a 60-day running regimen. For the final run, half of the Labradors from each treatment rested and half ran 24.1 km. Twenty-four Labradors received isotope infusion, and then, a biopsy of the biceps femoris of all 26 Labradors was taken to determine PT. Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042). LC females had a lower FBR v. P females (p = .046). EXP3: Respiration of 16 Labradors (8 M/8 F) was measured via indirect calorimetry over 15 week. All dogs ran on a treadmill for 30 min at 30% VO 2  max (6.5 kph), resulting in higher maximum and mean EE in LC females v. P females (p = .021; p = .035). Implications for theory, practice and future research are discussed.",2020,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"['muscle/serum of Labrador Retrievers', '16 Labradors (8 M/8 F']","['supplemented L-carnitine', 'EXP3', 'muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3', 'L-carnitine (LC) supplemented daily with 125\xa0mg L-carnitine and 3.75\xa0g sucrose or placebo (P) supplemented with 4\xa0g sucrose daily']","['protein turnover (PT), energy expenditure (EE) and carnitine metabolism', 'L-Carnitine metabolism, protein turnover and energy expenditure', 'fractional breakdown rate (FBR', 'L-Carnitine content']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0324431', 'cui_str': 'Labrador retriever'}, {'cui': 'C0022888', 'cui_str': 'Labrador'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0170811,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"[{'ForeName': 'Jessica Lyn', 'Initials': 'JL', 'LastName': 'Varney', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Jason William', 'Initials': 'JW', 'LastName': 'Fowler', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Trenda Clarice', 'Initials': 'TC', 'LastName': 'McClaughry', 'Affiliation': 'ELIAS Animal Health LLC, Olathe, KS, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Vignale', 'Affiliation': 'Kemin Industries Inc., Des Moines, IA, USA.'}, {'ForeName': 'Justina', 'Initials': 'J', 'LastName': 'Caldas', 'Affiliation': 'Cobb-Vantress Inc., Siloam Springs, AR, USA.'}, {'ForeName': 'Jordan Taylor', 'Initials': 'JT', 'LastName': 'Weil', 'Affiliation': 'University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Craig Nelson', 'Initials': 'CN', 'LastName': 'Coon', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}]",Journal of animal physiology and animal nutrition,['10.1111/jpn.13391']
1175,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND


Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome.
OBJECTIVE


To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours.
DESIGN


A two-armed randomized controlled trial.
SETTINGS AND PARTICIPANTS


A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China.
METHODS


The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program.
RESULTS


No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05).
CONCLUSIONS


The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638']
1176,32554035,Effect of a computer network-based feedback program on antibiotic prescription rates of primary care physicians: A cluster randomized crossover-controlled trial.,"OBJECTIVE


Antibiotic overuse is one of the major prescription problems in rural China and a major risk factor for antibiotic resistance. Low antibiotic prescription rates can effectively reduce the risk of antibiotic resistance. We hypothesized that under a paperless, computer-based feedback system the rates of antibiotic prescriptions among primary care physicians can be reduced.
METHODS


A cluster randomized crossover open controlled trial was conducted in 31 hospitals. These hospitals were randomly allocated to two groups to receive the intervention for three months followed by no intervention for three months in a random sequence. The feedback intervention information, which displayed the physicians' antibiotic prescription rates and ranking, was updated every 10 days. The primary outcome was the 10-day antibiotic prescription rate of the physicians.
RESULTS


There were 82 physicians in group 1 (intervention first followed by control) and 81 in group 2 (control first followed by intervention). Baseline comparison showed no significant difference in antibiotic prescription rate between the two groups (30.8% vs 35.2%, P-value=0.07). At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001). After a further 3 months, the rate of decline in antibiotic prescriptions was also significantly greater in the intervention group compared to the control group (14.2% vs 4.6%, P-value<0.001). The characteristics of physicians did not significantly determine the change in rate of antibiotic prescriptions.
CONCLUSION


A computer network-based feedback intervention can significantly reduce the antibiotic prescription rates of primary care outpatient physicians and continuously affected their prescription behavior for up to six months.
TRIAL REGISTRATION


ChiCTR1900021823.",2020,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","['31 hospitals', 'primary care physicians']","['computer network-based feedback intervention', 'computer network-based feedback program']","['rate of antibiotic prescriptions', 'antibiotic prescription rates', 'antibiotic prescription rate', 'risk of antibiotic resistance', '10-day antibiotic prescription rate of the physicians', 'rate of decline in antibiotic prescriptions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0905095,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China; Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Rassamee', 'Initials': 'R', 'LastName': 'Sangthong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'McNeil', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China. Electronic address: tlei1974@163.com.'}, {'ForeName': 'Virasakdi', 'Initials': 'V', 'LastName': 'Chongsuvivatwong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand. Electronic address: cvirasak@medicine.psu.ac.th.'}]",Journal of infection and public health,['10.1016/j.jiph.2020.05.027']
1177,32554067,Dexmedetomidine Provides Fewer Respiratory Events Compared With Propofol and Fentanyl During Third Molar Surgery: A Randomized Clinical Trial.,"PURPOSE


Propofol and fentanyl can cause airway obstruction and respiratory depression when used together for intravenous sedation. This study investigated whether dexmedetomidine and midazolam would decrease respiratory events requiring intervention during deep sedation compared with propofol, fentanyl, and midazolam.
PATIENTS AND METHODS


A prospective, randomized, double-blinded, controlled trial was designed to assess 2 intravenous treatment groups during third molar surgery. Patients were randomized into 2 groups. The control group (group P) received 0.8 μg/kg of fentanyl followed by propofol infusion at 125 μg/kg per minute over a 10-minute period with intraoperative boluses of 0.1 μg/kg. The study group (group D) received dexmedetomidine bolus infusion of 1 μg/kg over a 10-minute period followed by maintenance infusion at 0.5 μg/kg per hour. Both groups were given 0.03 mg/kg of midazolam before infusion. Scorers, masked to group, viewed the procedure remotely and evaluated the primary outcome variable of respiratory events requiring intervention. Secondary outcome variables evaluated by the scorers included the Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15 minutes, and time to ambulation and discharge. Patient satisfaction and hemodynamic stability were measured. The difference between groups regarding the occurrence of respiratory events was tested using the Fisher exact test, and mixed-effects models were used to compare repeated vital signs.
RESULTS


The sample was composed of 141 patients randomly assigned to either group P (n = 67) or group D (n = 74). No statistically significant differences in the distribution of study variables were found between groups at baseline. A statistically significant difference in respiratory events requiring deliberate intervention existed between group P (25.4%) and group D (2.7%) (P < .0001). No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
CONCLUSIONS


Using dexmedetomidine and midazolam for outpatient surgery resulted in fewer respiratory events requiring deliberate intervention compared with propofol, fentanyl, and midazolam. Ambulation and discharge times were not prolonged using dexmedetomidine.",2020,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
",['141 patients randomly assigned to either group P (n\xa0=\xa067) or group D'],"['dexmedetomidine bolus infusion of 1\xa0μg/kg over a 10-minute period followed by maintenance infusion', 'Dexmedetomidine', 'Propofol and Fentanyl', 'Propofol and fentanyl', 'fentanyl followed by propofol infusion', 'propofol, fentanyl, and midazolam', 'dexmedetomidine and midazolam', 'midazolam', 'dexmedetomidine']","['occurrence of respiratory events', 'Respiratory Events', 'respiratory events', 'Patient satisfaction and hemodynamic stability', 'Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction', 'Behavioral Pain Scale for non-intubated patients at initial injection, cooperation score at 5 and 15\xa0minutes, and time to ambulation and discharge', 'Ambulation and discharge times']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}]",141.0,0.396816,"No statistically significant difference was found between groups for Behavioral Pain Scale score, cooperation score, time to ambulation or discharge, and patient satisfaction.
","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Nolan', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY. Electronic address: PNOLAN@montefiore.org.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Delgadillo', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Youssef', 'Affiliation': 'Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Professor of Biomedical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Chehrehsa', 'Affiliation': 'Former Resident, Division of Oral and Maxillofacial Surgery, Department of Dentistry, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.015']
1178,32555067,Laparoscopic Total Extraperitoneal Inguinal Hernia Repair Under Epidural Anesthesia Versus General Anesthesia.,"INTRODUCTION


Laparoscopic total extraperitoneal (TEP) inguinal hernia repair is a well-known approach to inguinal hernia repair. The present study aims to compare the advantages and disadvantages of the TEP technique under general anesthesia (GA) and epidural anesthesia (EA).
MATERIALS AND METHODS


The patients were divided into 2 groups as those undergoing TEP under EA (Group 1) and those undergoing TEP under GA (Group 2). The 2 patient groups were compared in terms of sex, age, body mass index data, duration of surgery, total operation time, patient satisfaction, VAS scores (1, 4, 12, and 24 h), length of hospital stay, and postoperative complications.
RESULTS


The number of patients operated under EA (Group 1) was 30, and the number of patients operated under GA (Group 2) was 32. Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001). The mean operation time was recorded as 62 and 46.50 minutes in Groups 1 and 2, respectively, which was statistically significantly shorter in Group 2 (P<0.001). There was no difference between the 2 groups regarding complications, hospital stay, recovery, or surgery time. Conversion rate is 0 in both groups.
CONCLUSIONS


Lower postoperative VAS scores and lower postoperative VAS scores and lower analgesic used requirements of EA, it is thought that EA can be safely applied in the TEP procedure as an alternative in patients who cannot be administered GA.",2020,Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001).,['patients who cannot be administered GA'],"['Epidural Anesthesia Versus General Anesthesia', 'TEP under GA', 'Laparoscopic total extraperitoneal ', 'TEP technique under general anesthesia (GA) and epidural anesthesia (EA', 'Laparoscopic Total Extraperitoneal Inguinal Hernia Repair', 'TEP under EA']","['postoperative VAS scores and lower postoperative VAS scores', 'body mass index data, duration of surgery, total operation time, patient satisfaction, VAS scores', 'complications, hospital stay, recovery, or surgery time', 'Conversion rate', 'length of hospital stay, and postoperative complications', 'need for analgesia', 'postoperative first hour VAS scores', 'mean operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0373588,Only in the postoperative first hour VAS scores was statistically significantly less and the need for analgesia evaluated in both groups was found to be statistically significantly lower in Group 1 (P<0.001).,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sürek', 'Affiliation': 'General Surgery Department, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Abdussamet', 'Initials': 'MA', 'LastName': 'Bozkurt', 'Affiliation': ''}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Ferahman', 'Affiliation': ''}, {'ForeName': 'Eyüp', 'Initials': 'E', 'LastName': 'Gemici', 'Affiliation': ''}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Dönmez', 'Affiliation': ''}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000817']
1179,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE


Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.
METHODS


Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.
RESULTS


From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.
CONCLUSIONS


Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016']
1180,32559759,Short-term nicotine deprivation alters dorsal anterior cingulate glutamate concentration and concomitant cingulate-cortical functional connectivity.,"Most cigarette smokers who wish to quit too often relapse within the first few days of abstinence, primarily due to the aversive aspects of the nicotine withdrawal syndrome (NWS), which remains poorly understood. Considerable research has suggested that the dorsal anterior cingulate cortex (dACC) plays a key role in nicotine dependence, with its functional connections between other brain regions altered as a function of trait addiction and state withdrawal. The flow of information between dACC and fronto-striatal regions is secured through different pathways, the vast majority of which are glutamatergic. As such, we investigated dACC activity using resting state functional connectivity (rsFC) with functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS). We also investigated the changes in adenosine levels in plasma during withdrawal as a surrogate for brain adenosine, which plays a role in fine-tuning synaptic glutamate transmission. Using a double-blind, placebo-controlled, randomized crossover design, nontreatment seeking smoking participants (N = 30) completed two imaging sessions, one while nicotine sated and another after 36 h nicotine abstinence. We observed reduced dACC Glu (P = 0.029) along with a significant reduction in plasma adenosine (P = 0.03) and adenosine monophosphate (AMP; P < 0.0001) concentrations during nicotine withdrawal in comparison with nicotine sated state. This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG). Moreover, the state-trait changes in dACC Glu and rsFC strength between the dACC and both SFG and MFG were positively correlated (P = 0.012, and P = 0.007, respectively). Finally, the change in circuit strength between dACC and LSFG was negatively correlated with the change in withdrawal symptom manifestations as measured by the Wisconsin Smoking Withdrawal Scale (P = 0.04) and Tobacco Craving Questionnaire (P = 0.014). These multimodal imaging-behavioral findings reveal the complex cascade of changes induced by acute nicotine deprivation and call for further investigation into the potential utility of adenosine- and glutamate-signaling as novel therapeutic targets to treat the NWS.",2020,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).",['nontreatment seeking smoking participants (N\u2009=\u200930) completed two'],"['placebo', 'Short-term nicotine deprivation', 'imaging sessions, one while nicotine sated and another after 36\u2009h nicotine abstinence', 'functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS']","['plasma adenosine', 'left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG', 'Wisconsin Smoking Withdrawal Scale', 'dACC Glu', 'dACC Glu and rsFC strength', 'rsFC strength', 'withdrawal symptom manifestations', 'circuit strength', 'Tobacco Craving Questionnaire']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0275209,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA. osama.abulseoud@nih.gov.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology, Toxicology and Neuroscience, LSU Health Sciences Center, Shreveport, LA, USA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Caparelli', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tennekoon', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Schleyer', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fedota', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0741-9']
1181,32560069,Effects of a Physical Education Intervention on Academic Performance: A Cluster Randomised Controlled Trial.,"BACKGROUND


We investigated the effects of three different interventions on academic performance in students enrolled in the first year of high school.
METHODS


This was a cluster randomised controlled trial conducted with 1200 students enrolled in the first year of high school. Schools were randomly assigned to: 1. Doubling physical education (PE) classes (3:20 h of PE/week); 2. workshop with the PE teachers; 3. workshop with the PE teachers and doubling the PE classes; and 4. control group (1:40 h of PE/week). We assured that the schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom.
RESULTS


Overall, the intervention was not effective in improving the students' academic performance. However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
CONCLUSIONS


Enhancing the pedagogical skills of the teachers is a promising approach in improving the academic performance of students who failed an academic year.",2020,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","['1200 students enrolled in the first year of high school', 'students enrolled in the first year of high school', 'schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom', 'students who failed an academic year']","['workshop intervention', 'Physical Education Intervention']","[""students' academic performance"", 'academic performance', 'Doubling physical education (PE) classes', 'Academic Performance']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1200.0,0.0519151,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sport Science, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bezerra', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Mauro Virgílio Gomes', 'Initials': 'MVG', 'LastName': 'de Barros', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17124287']
1182,32561505,Effect of different types of exercises on psychological and cognitive features in people with Parkinson's disease: A randomized controlled trial.,"BACKGROUND


Parkinson's disease (PD) is a neurodegenerative and progressive disease marked by the presence of motor and non-motor symptoms, as psychological and cognitive impairment. Physical exercises have been prescribed as complementary therapy for PD, and the type of intervention and duration of the intervention should be taken into account.
OBJECTIVE


We aimed to compare the effect of different exercise modalities (functional mobility, multimodal and cognitive) and length (4 and 8 months) on psychological and cognition in people with PD. This study followed the CONSORT extension for non-pharmacological trials.
METHODS


In this randomized controlled trial, we assessed 107 participants between 2011 and 2013. At the end of 3 years, participants with PD (mild to moderate stages) who achieved the criteria were assessed considering 3 different groups of exercise: Multimodal (n=38), Functional Mobility (n=33) and Mental/Leisure (n=36). All 3 interventions were performed for 32 weeks, twice a week, with 60min for each session (64 sessions in total). Psychological and cognitive function were assessed at baseline and after 4 and 8 months.
RESULTS


The Functional Mobility and Mental/Leisure training had a potential effect on maintaining cognitive function (executive function, attention and work memory). The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
CONCLUSIONS


An intervention that requires high complexity and specific activities, such as locomotor and cognitive exercise, provides a maintenance effect against the degeneration in cognition associated with the progression of PD and thus can delay the progressive decline in cognitive function in PD.",2020,"The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
","['107 participants between 2011 and 2013', ""people with Parkinson's disease"", 'participants with PD (mild to moderate stages) who achieved the criteria were assessed considering 3 different groups of exercise: Multimodal (n=38), Functional Mobility (n=33) and Mental/Leisure (n=36', 'people with PD']","['Physical exercises', 'exercise modalities (functional mobility, multimodal and cognitive) and length (4 and 8 months', 'Multimodal training', 'exercises']","['physical stress', 'psychological and cognition', 'psychological and cognitive features', 'Psychological and cognitive function', 'maintaining cognitive function (executive function, attention and work memory']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0231302', 'cui_str': 'Physical stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",107.0,0.0517501,"The Multimodal training did not show a benefit for cognitive features and was not even able to delay the progressive decline in cognitive functions; however, this modality had a positive effect on physical stress after 8 months of exercise.
","[{'ForeName': 'Lilian Teresa Bucken', 'Initials': 'LTB', 'LastName': 'Gobbi', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil. Electronic address: lilian.gobbi@unesp.br.'}, {'ForeName': 'Paulo Henrique Silva', 'Initials': 'PHS', 'LastName': 'Pelicioni', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Lahr', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lirani-Silva', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Teixeira-Arroyo', 'Affiliation': 'Centro Universitário UNIFAFIBE, Bebedouro, São Paulo, Brazil.'}, {'ForeName': 'Paulo Cezar Rocha Dos', 'Initials': 'PCRD', 'LastName': 'Santos', 'Affiliation': 'São Paulo State University (UNESP), Post-graduation Program in Movement Sciences, Institute of Biosciences, Posture and Gait Studies Laboratory (LEPLO), Rio Claro, Brazil; University of Groningen, University Medical Center Groningen, Center for Human Movement Sciences, Groningen, The Netherlands.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.05.011']
1183,32560872,The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in pregnant women with lumbopelvic pain: A cross-over study.,"BACKGROUND


Pelvic belt is being used to alleviate the symptoms of lumbopelvic pain.
OBJECTIVE


To investigate the immediate effects of a pelvic belt with a textured sacral pad in pregnant women with lumbopelvic pain.
METHODS


Twenty-eight pregnant women participated in a randomized crossover study. Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain. Outcomes were measured in three randomized conditions including no pelvic belt (control), with a pelvic belt, and while a sacral pad was used with the pelvic belt. Data were analyzed using a one-way repeated measures analysis of variance for each variable.
RESULTS


Improvements in all study outcomes have been shown with a pelvic belt compared with the control condition. The addition of a textured sacral pad to the pelvic belt improved all study outcomes compared with the pelvic belt: hip joint position sense (p < 0.001; 95% confidence interval:1.3to2.3), perceived effort (p = 0.003; 95% confidence interval: 0.35 to 1.86), and maximum flexion force (p < 0.001; 95% confidence interval:2.77to6.47) in the active straight leg raising.
CONCLUSION


Further improvements were noted with the addition of the textured pad for all outcome measures. This finding may inform new benefits in adding a textured sacral pad to pelvic compression belts.",2020,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","['pregnant women with lumbopelvic pain', 'Twenty-eight pregnant women participated', 'twenty-eight pregnant women with lumbopelvic pain']","['pelvic belt with a textured sacral pad', 'pelvic compression belt with a textured sacral pad']","['sacroiliac function', 'Hip joint position sense, maximum hip flexion force, and perceived effort', 'maximum flexion force']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",28.0,0.208761,"Hip joint position sense, maximum hip flexion force, and perceived effort during the active straight leg raising test were measured in twenty-eight pregnant women with lumbopelvic pain.","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Delshad', 'Affiliation': 'Student Research Committee, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Zarean', 'Affiliation': 'Department of Obstetrics and Gynecology, Feto-maternal Medicine Unit, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Yeowell', 'Affiliation': 'Department of Health Professions, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Sadeghi-Demneh', 'Affiliation': 'Musculoskeletal Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sadeghi@rehab.mui.ac.ir.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102170']
1184,32566130,Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia.,"Background:  Speech and language therapy is typically initiated reactively after a child shows delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).   Method : Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing.  Results :  All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG.  Discussion:  Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization.  Trial registration:  ClinicalTrials.gov NCT03838016 (12  th  February 2019).",2019,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","['infants with classic galactosemia', 'children with CG', 'Infants with classic galactosemia (CG', 'Method : Five children with CG, otherwise healthy, participated in the BBC from approximately 2 to 24 months of age']","['Babble Boot Camp', 'proactive speech and language treatment', 'control receiving conventional management', 'innovative proactive speech and language intervention program, the Babble Boot Camp (BBC', ':  Speech or language therapy']","['speech sound production, expressive language, and communication milestones', 'developmental milestones in communication, motor, and cognition', 'speech sound production complexity in babble and speech and expressive vocabulary size', 'higher communication and personal-social skills', 'higher speech sound skills', 'prespeech, speech, and language stimulation and expansion activities']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0268151', 'cui_str': 'Deficiency of UDPglucose-hexose-1-phosphate uridylyltransferase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023017', 'cui_str': 'Language therapy'}]","[{'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0589217', 'cui_str': 'Language stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",5.0,0.032084,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Potter', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Donenfeld-Peled', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Finestack', 'Affiliation': 'Department of Speech-Language-Hearing Services, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stoel-Gammon', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Bruce', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Vose', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Eng', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olds', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'VanDam', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",F1000Research,['10.12688/f1000research.18062.5']
1185,32578332,"Transurethral en bloc submucosal hydrodissection vs conventional resection for resection of non-muscle-invasive bladder cancer (HYBRIDBLUE): a randomised, multicentre trial.","OBJECTIVE


To determine whether transurethral en bloc submucosal hydrodissection of bladder tumours (TUEB) improves the quality of the resection compared to conventional transurethral resection of bladder tumour (TURBT) in patients with non-muscle-invasive bladder cancer (NMIBC).
PATIENTS AND METHODS


A randomised, multicentre trial (HYBRIDBLUE) was conducted with a superiority design. Six German academic centres participated between September 2012 and August 2015. Based on literature analysis, a sample size for accurate histopathological assessment concerning muscle invasion was assumed to be feasible in 50% (P 0  = 0.5) of TURBT and 80% of TUEB cases. After pre-screening of a total of 305 patients, participants were allocated to two study arms: Group I: hexaminolevulinate (HAL)-guided TUEB; Group II: conventional HAL-guided TURBT. The primary endpoint was the proportion of specimens that could be reliably evaluated pathologically concerning muscle invasiveness. Secondary endpoints included rates of histopathological completeness of the resection, muscularis propria content, recurrence, and complication rates.
RESULTS


A total of 115 patients (TUEB 56; TURBT 59) were eligible for final analysis. Adequate histopathological assessment, which included muscularis propria content and tumour margins (R0 vs R1), was present in 48/56 (86%) TUEB patients compared to 37/59 (63%; P = 0.006) in the TURBT group. R0 was confirmed in 30/56 TUEB patients (57%) and five of 59 TURBT patients (9%; P < 0.001). No complications of Grade ≥III were observed in both arms. At 3 and 12 months, three and 19 patients recurred in the TUEB group vs seven and 11 patients in the TURBT group, respectively (P = 0.33 and P = 0.08).
CONCLUSIONS


In this randomised study, TUEB was shown to be clinically safe regarding perioperative endpoints. An adequate histopathological assessment concerning muscle invasion was significantly better assessable in the TUEB arm compared to standard TURBT. This finding indicates the clinical potential for reducing the rate of early re-resections. Yet, a larger study with recurrence-free survival as the primary endpoint is needed to assess the oncological efficacy between both techniques.",2020,An adequate histopathological assessment concerning muscle-invasion was significantly better assessable in the TUEB arm compared to standard TURBT.,"['non-muscle invasive bladder cancer (HYBRIDBLUE', 'Six German academic centres participated between 09/2012 and 08/2015', 'One hundred-and-fifteen patients (TUEB: 56; TURBT: 59) were eligible for final analysis', 'patients with NMIBC']","['Transurethral en bloc submucosal hydrodissection versus conventional resection', 'conventional HAL-guided TURBT', 'TUEB', 'transurethral en bloc submucosal hydrodissection of bladder tumours (TUEB', 'hexaminolevulinate(HAL)-guided TUEB', 'conventional transurethral resection (TURBT']","['rates of histopathological completeness of the resection, muscularis propria content, recurrence and complication rates', 'oncological efficacy', 'R0', 'proportion of specimens which could be reliably evaluated pathologically concerning muscle-invasiveness']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0720810', 'cui_str': 'Halotestin'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1327841', 'cui_str': 'hexyl 5-aminolevulinate'}]","[{'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225358', 'cui_str': 'Muscularis propria'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",305.0,0.140396,An adequate histopathological assessment concerning muscle-invasion was significantly better assessable in the TUEB arm compared to standard TURBT.,"[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gakis', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karl', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bertz', 'Affiliation': 'Department of Pathology, University Hospital of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': 'Department of Urology, Caritas St. Josef Hospital, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Fritsche', 'Affiliation': 'Department of Urology, Caritas St. Josef Hospital, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Department of Pathology, University Hospital of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Jokisch', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kempkensteffen', 'Affiliation': 'Department of Urology, Charite, University Hospital of Berlin, Berlin, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Department of Urology, Charite, University Hospital of Berlin, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Mundhenk', 'Affiliation': 'Department of Urology, Diakonie-Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Birte-Swantje', 'Initials': 'BS', 'LastName': 'Schneevoigt', 'Affiliation': 'Department of Urology, University Hospital of Munich-Grosshadern, Munich, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Schubert', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwentner', 'Affiliation': 'Department of Urology, Diakonie-Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wullich', 'Affiliation': 'Department of Urology and Pediatric Urology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Hospital of Tübingen, Tübingen, Germany.'}]",BJU international,['10.1111/bju.15150']
1186,32568196,"Safety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-to-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.","BACKGROUND


Crenezumab is a fully humanized, monoclonal anti-amyloid-β immunoglobulin G4 antibody.
OBJECTIVE


This Phase Ib study (NCT02353598) evaluated the safety, tolerability, and pharmacokinetics of crenezumabat doses of ≤120 mg/kg administered intravenously every 4 weeks (q4w). Immunogenicity and exploratory biomarkers were also evaluated.
METHODS


In this multicenter, double-blind study, participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive positron emission tomography (PET) scan were randomized to receive crenezumab 30 or 45 mg/kg (Cohort 1, n = 21), 60 mg/kg (Cohort 2, n = 21), or 120 mg/kg (Cohort 3, n = 19) or corresponding placebo (n = 14) intravenously q4w for 13 weeks. Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received crenezumab at the originally assigned dose level, except for Cohort 3 (crenezumab 60 mg/kg during OLE). Participants received regular brain MRIs to assess amyloid-related imaging abnormalities (ARIA). Results up to Week 133 are reported.
RESULTS


Approximately 94% of participants experienced ≥1 adverse event (AE). Most AEs were mild or moderate; 15.5% experienced a Grade ≥3 AE. No ARIA-edema/effusion (ARIA-E) events were observed. New ARIA-micro hemorrhages and hemosiderosis (ARIA-H) were reported in 4.9% (double-blind treatment period) and 9.9% (combined double-blind treatment and OLE periods) of participants. Steady-state trough concentrations of crenezumab were dose-proportional and maintained for each dose level.
CONCLUSION


Crenezumab doses of ≤120 mg/kg intravenously q4w were well tolerated. The observed safety profile for ≤133 weeks of treatment in a mild-to-moderate AD population was similar to that seen in previous trials.",2020,No ARIA-edema/effusion (ARIA-E) events were observed.,"[""Patients with Mild-To-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133\xa0Weeks"", ""participants (aged 50-90 years) with mild-to-moderate Alzheimer's disease (AD) and amyloid-positive PET scan"", 'Seventy-one participants were subsequently enrolled in an optional open-label extension (OLE) and received']","['regular brain MRIs', 'crenezumab', 'placebo']","['xSafety, Tolerability, and Pharmacokinetics of Crenezumab', 'New ARIA-micro hemorrhages and hemosiderosis (ARIA-H', 'tolerated', '≥1 adverse event (AE', 'safety, tolerability, and pharmacokinetics', 'Immunogenicity and exploratory biomarkers', 'No ARIA-edema/effusion (ARIA-E) events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3493199', 'cui_str': 'crenezumab'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3495884', 'cui_str': 'Amyloid related imaging abnormalities'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019114', 'cui_str': 'Hemosiderosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3267084', 'cui_str': 'Amyloid related imaging abnormality-oedema/effusion'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",71.0,0.439878,No ARIA-edema/effusion (ARIA-E) events were observed.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Guthrie', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Honig', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Blondeau', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Quartino', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dolton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carrasco-Triguero', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bittner', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ostrowitzki', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200134']
1187,32576297,Comparison of whole egg  v . egg white ingestion during 12 weeks of resistance training on skeletal muscle regulatory markers in resistance-trained men.,"Eggs are considered a high-quality protein source for their complete amino acid profile and digestibility. Therefore, this study aimed to compare the effects of whole egg (WE) v. egg white (EW) ingestion during 12 weeks of resistance training (RT) on the skeletal muscle regulatory markers and body composition in resistance-trained men. Thirty resistance-trained men (mean age 24·6 (sd 2·7) years) were randomly assigned into the WE + RT (WER, n 15) or EW + RT (EWR, n 15) group. The WER group ingested three WE, while the EWR group ingested an isonitrogenous quantity of six EW per d immediately after the RT session. Serum concentrations of regulatory markers and body composition were measured at baseline and after 12 weeks. Significant main effects of time were observed for body weight (WER 1·7, EWR 1·8 kg), skeletal muscle mass (WER 2·9, EWR 2·7 kg), fibroblast growth factor-2 (WER 116·1, EWR 83·2 pg/ml) and follistatin (WER 0·05, EWR 0·04 ng/ml), which significantly increased (P < 0·05), and for fat mass (WER -1·9, EWR -1·1 kg), transforming growth factor-β1 (WER -0·5, EWR -0·1 ng/ml), activin A (WER -6·2, EWR -4·5 pg/ml) and myostatin (WER -0·1, EWR -0·06 ng/ml), which significantly decreased (P < 0·05) in both WER and EWR groups. The consumption of eggs absent of yolk during chronic RT resulted in similar body composition and functional outcomes as WE of equal protein value. EW or WE may be used interchangeably for the dietary support of RT-induced muscular hypertrophy when protein intake is maintained.",2020,"ng.ml], which significantly decreased (p ˂ 0.05) in both the WER and EWR groups.","['resistance-trained men', 'Thirty resistance-trained men (24.6 ± 2.7 years']","['whole egg (WE) vs. egg white (EW) ingestion', 'whole egg vs. egg white ingestion', 'resistance training (RT', 'resistance training', 'EW + RT (EWR']","['Serum concentrations of regulatory markers and body composition', 'myostatin [WER', 'Fibroblast growth factor', 'skeletal muscle regulatory markers', 'skeletal muscle mass', 'Transforming growth factor-β1']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0016026', 'cui_str': 'Fibroblast growth factor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}]",,0.133598,"ng.ml], which significantly decreased (p ˂ 0.05) in both the WER and EWR groups.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, 8174673441, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi university of Mashhad, Mashhad, 9177948974, Iran.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jo', 'Affiliation': 'Kinesiology & Health Promotion Department, California State Polytechnic University Pomona, Pomona, CA91768-2557, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX79409, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX79409, USA.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 61357-15794, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, 9717434765, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, TX22207, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002238']
1188,32578325,Spaced education and student learning: Results from a medical school.,"BACKGROUND


It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians. Poor long-term retention is a pervasive concern. We investigated the impact of 'spaced education' teaching modules to improve knowledge retention in medical students on a topic of public health: vitamin D and its role in health and disease. It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians METHODS: In a self-matched design, 148 medical students were randomised and evaluated on vitamin D-related topics to assess reinforced and non-reinforced knowledge in a multiple-choice question format. Initial learning and long-term retention were assessed with an estimation of Cohen's effect size at 24 and 72 weeks, respectively.
RESULTS


The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33). Although the scores dipped, there was a retention of knowledge at 72 weeks (effect size = 0.48).
DISCUSSION


Spaced reinforcement and testing statistically improved knowledge retention among our medical students. Gaps in the present teaching could be bridged by motivating the students to extend their learning time by appropriate spacing intervals and to understand the relevance of course content in different scenarios as a physician. Further research could be instrumental in optimising interventions to enhance learning opportunities for medical students.",2020,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","['medical students on a topic of public health', 'medical students', '148 medical students']",['vitamin\xa0D-related topics to assess reinforced and non-reinforced knowledge'],"['knowledge retention', 'Initial learning and long-term retention', 'retention of knowledge', 'composite formative test scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",148.0,0.028314,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","[{'ForeName': 'Preeta K', 'Initials': 'PK', 'LastName': 'Chugh', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Tripathi', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}]",The clinical teacher,['10.1111/tct.13180']
1189,32575482,Randomised Controlled Feasibility Study of the MyHealthAvatar-Diabetes Smartphone App for Reducing Prolonged Sitting Time in Type 2 Diabetes Mellitus.,"This study evaluated the feasibility and acceptability of a self-regulation smartphone app for reducing prolonged sitting in people with Type 2 diabetes mellitus (T2DM). This was a two-arm, randomised, controlled feasibility trial. The intervention group used the MyHealthAvatar-Diabetes smartphone app for 8 weeks. The app uses a number of behaviour change techniques aimed at reducing and breaking up sitting time. Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility. Interviews with participants explored intervention acceptability. Participants with T2DM were randomised to the control ( n  = 10) and intervention groups ( n  = 10). Recruitment and retention rates were 71% and 90%, respectively. The remaining participants provided 100% of data for the study measures. The MyHealthAvatar-Diabetes app was viewed as acceptable for reducing and breaking up sitting time. There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group. In conclusion, the findings indicate that it would be feasible to deliver and evaluate the efficacy of the MyHealthAvatar-Diabetes app for breaking up sitting time and improving health outcomes in a full trial.",2020,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","['Participants with T2DM', 'Type 2 Diabetes Mellitus', 'people with Type 2 diabetes mellitus (T2DM']","['MyHealthAvatar-Diabetes smartphone', 'self-regulation smartphone app', 'MyHealthAvatar-Diabetes Smartphone App']","['number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect', 'Recruitment and retention rates', 'Eligibility, recruitment, retention, and completion rates for the outcomes (sitting, standing, stepping, and health-related measures) assessed trial feasibility', 'health outcomes', 'Prolonged Sitting Time']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0445131', 'cui_str': 'Number of breaks'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0458148,"There were preliminary improvements in the number of breaks in sitting per day, body fat %, glucose tolerance, attitude, intention, planning, wellbeing, and positive and negative affect in favour of the intervention group.","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge UB8 3PH, UK.'}, {'ForeName': 'Lucie H', 'Initials': 'LH', 'LastName': 'Mugridge', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Department of Computer and Information Sciences, University of Strathclyde, Glasgow G1 1XH, UK.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute for Research in Applicable Computing, University of Bedfordshire, Luton LU1 3JU, UK.'}, {'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'Chater', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire, Polhill Avenue, Bedford MK41 9EA, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17124414']
1190,32575611,"Effect of a Flaxseed Lignan Intervention on Circulating Bile Acids in a Placebo-Controlled Randomized, Crossover Trial.","Plant lignans and their microbial metabolites, e.g., enterolactone (ENL), may affect bile acid (BA) metabolism through interaction with hepatic receptors. We evaluated the effects of a flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside) compared to a placebo for 60 days each on plasma BA concentrations in 46 healthy men and women (20-45 years) using samples from a completed randomized, crossover intervention. Twenty BA species were measured in fasting plasma using LC-MS. ENL was measured in 24-h urines by GC-MS. We tested for (a) effects of the intervention on BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL. We also explored the overlap in bacterial metabolism at the genus level and conducted in vitro anaerobic incubations of stool with lignan substrate to identify genes that are enriched in response to lignan metabolism. There were no intervention effects, overall or stratified by ENL at FDR < 0.05. In the cross-sectional analysis, irrespective of treatment, five secondary BAs were associated with ENL excretion (FDR < 0.05). In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases. These data suggest overlap in community bacterial metabolism of secondary BA and ENL.",2020,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,['46 healthy men and women (20-45 years) using samples'],"['flaxseed lignan extract (50 mg/day secoisolariciresinol diglucoside', 'Flaxseed Lignan Intervention', 'placebo']","['fasting plasma using LC-MS', 'Circulating Bile Acids', 'BA concentrations overall and stratified by ENL excretion; and (b) cross-sectional associations between plasma BA and ENL', 'plasma BA concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0045341', 'cui_str': ""2,3-bis(3'-hydroxybenzyl)butyrolactone""}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",46.0,0.0675738,In vitro analyses showed positive associations between ENL production and bacterial gene expression of the bile acid-inducible gene cluster and hydroxysteroid dehydrogenases.,"[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Curtis', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Elkon', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Orsalem J', 'Initials': 'OJ', 'LastName': 'Kahsai', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Hamza S', 'Initials': 'HS', 'LastName': 'Ammar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Natalie N', 'Initials': 'NN', 'LastName': 'Hong', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Carnevale Neto', 'Affiliation': 'Northwest Metabolomics Research Center, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA 98109, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Chapkin', 'Affiliation': 'Program in Integrative Nutrition & Complex Diseases, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}]",Nutrients,['10.3390/nu12061837']
1191,32572510,Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,"BACKGROUND


In the surgical treatment of breast ptosis, the plastic surgeon's main challenge is to mobilize the nipple-areola complex (NAC) over long distances, preserving its sensitivity. Herein, we aimed to evaluate the NAC sensitivity following a periareolar dermis release in patients undergoing surgical correction of breast ptosis.
METHODS


This is a prospective, double-blinded, randomized study in which 39 patients (78 breasts) were operated on for the treatment of breast ptosis. Patients' breasts were divided into two groups, each breast in a group. In breasts of the experiment group, the periareolar dermis release was used after decortication. This maneuver was not used in the control group's breasts. To analyze the sensitivity in relation with the distance that the NAC should be mobilized to correct breast ptosis, the value of 6 cm was used as boundary. Sensitivity of the NAC was assessed with monofilaments preoperatively and postoperatively-at three and six weeks and one year.
RESULTS


Regarding the sensitivity of the areola, a significant difference was observed in the comparison between the control and experiment groups at the NAC mobility ≤ 6.0 cm in the preoperative. Regarding the nipple, a significant difference was observed in the comparison between the control and experiment groups at three weeks postoperatively for a NAC mobility ≤ 6.0 cm. After one year, there was no difference in the comparison between the groups in either areola or nipple.
CONCLUSION


The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
","['39 patients (78 breasts', ""Patients' breasts"", 'Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release', 'patients undergoing surgical correction of breast ptosis', 'patients undergoing breast ptosis correction']",[],"['Sensitivity of the NAC', 'NAC sensitivity', 'periareolar dermis release']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0314583,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
","[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'Sá', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa Cruz Oliveira', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil. f.santacruzoliveira@gmail.com.'}, {'ForeName': 'William Flávio', 'Initials': 'WF', 'LastName': 'Santinoni', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Freire', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine', 'Initials': 'JL', 'LastName': 'de Andrade Aguiar', 'Affiliation': 'Experimental Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01835-7']
1192,32575441,Modulation of Endothelial Glycocalyx and Microcirculation in Healthy Young Men during High-Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract. A Randomized Controlled Trial.,"The natural components of the pomegranate fruit may provide additional benefits for endothelial function and microcirculation. It was hypothesized that supplementation with pomegranate extract might improve glycocalyx properties and microcirculation during acute high-intensity sprint interval cycling exercise. Eighteen healthy and recreationally active male volunteers 22-28 years of age were recruited randomly to the experimental and control groups. The experimental group was supplemented with pomegranate extract 20 mL (720 mg phenolic compounds) for two weeks. At the beginning and end of the study, the participants completed a high-intensity sprint interval cycling-exercise protocol. The microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration were evaluated before and after the initial and repeated (after 2 weeks supplementation) exercise bouts. There were no significant differences in the microcirculation or glycocalyx over the course of the study ( p  < 0.05). The lactate concentration was significantly higher in both groups after the initial and repeated exercise bouts, and were significantly higher in the experimental group compared to the control group after the repeated bout: 13.2 (11.9-14.8) vs. 10.3 (9.3-12.7) mmol/L,  p  = 0.017. Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise. Although an unexplained rise in blood lactate concentration was observed.",2020,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"['Healthy Young Men during High', 'Eighteen healthy and recreationally active male volunteers 22-28 years of age']","['pomegranate extract 20 mL', 'Intensity Sprint Interval Cycling-Exercise by Supplementation with Pomegranate Extract', 'high-intensity sprint interval cycling-exercise protocol', 'supplementation with pomegranate extract']","['microcirculation or glycocalyx', 'lactate concentration', 'glycocalyx properties and microcirculation', 'blood lactate concentration', 'microcirculation flow and density parameters, glycocalyx markers, systemic hemodynamics, lactate, and glucose concentration', 'microcirculation and glycocalyx']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",18.0,0.0780625,Two weeks of supplementation with pomegranate extract does not influence changes in the microcirculation and glycocalyx during acute high-intensity sprint interval cycling-exercise.,"[{'ForeName': 'Zivile', 'Initials': 'Z', 'LastName': 'Pranskuniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Belousoviene', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Neringa', 'Initials': 'N', 'LastName': 'Baranauskiene', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Nerijus', 'Initials': 'N', 'LastName': 'Eimantas', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Vaitkaitiene', 'Affiliation': 'Department of Disaster Medicine and Health Research Institute, Lithuanian University of Health Sciences, Eiveniu g. 4, LT-50161 Kaunas, Lithuania.'}, {'ForeName': 'Jurga', 'Initials': 'J', 'LastName': 'Bernatoniene', 'Affiliation': 'Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu pr.13, LT-50162 Kaunas, Lithuania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Institute of Sport Science and Innovation, Lithuanian Sports University, Sporto g. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Pranskunas', 'Affiliation': 'Department of Intensive Care Medicine, Lithuanian University of Health Sciences, Eiveniu g. 2, LT-50161 Kaunas, Lithuania.'}]",International journal of environmental research and public health,['10.3390/ijerph17124405']
1193,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND


Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS


We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS


A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS


There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1194,32571870,Long-term efficacy and safety of canakinumab in patients with colchicine-resistant familial Mediterranean fever: results from the randomised phase III CLUSTER trial.,"OBJECTIVES


To evaluate the long-term efficacy and safety of canakinumab to treat patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study.
METHODS


Patients received open-label canakinumab 150 or 300 mg, every 4 or 8 weeks during a 72-week period. We evaluated disease activity every 8 weeks using the physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA). Safety was studied by determination and classification of observed adverse events (AEs). We analysed safety and efficacy separately in two subgroups of patients receiving a cumulative dose of less than 2700 mg, or equal or more than 2700 mg.
RESULTS


Of the 61 patients that started the CLUSTER study, 60 entered Epoch 4 and 57 completed it. During the 72-week period, 35/60 (58.3%) patients experienced no flares, and 23/60 (38.3%) had one flare, as compared with a median of 17.5 flares per year reported at baseline. PGA scores indicated no disease activity for the majority of patients throughout the study. Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold. No new or unexpected AEs were reported.
CONCLUSION


crFMF patients treated with canakinumab during 72 weeks experienced a minimal incidence of flares and good control of clinical disease activity, with no new safety concerns reported.",2020,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","['two subgroups of patients receiving a cumulative dose of less than 2700\u2009mg, or equal or more than 2700\u2009mg', 'patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study', '61 patients that started the CLUSTER study', 'patients with colchicine-resistant familial Mediterranean fever', 'Patients received']","['canakinumab', 'open-label canakinumab']","['physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA', 'disease activity', 'minimal incidence of flares and good control of clinical disease activity', 'Median CRP concentrations', 'median SAA concentrations', 'safety and efficacy', 'PGA scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0459372,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","[{'ForeName': 'Seza', 'Initials': 'S', 'LastName': 'Ozen', 'Affiliation': 'Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey sezaozen@gmail.com.'}, {'ForeName': 'Eldad', 'Initials': 'E', 'LastName': 'Ben-Cherit', 'Affiliation': 'Rheumatology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Foeldvari', 'Affiliation': 'Pediatric Rheumatology, Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Amarilyo', 'Affiliation': ""Pediatric Rheumatology Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Huri', 'Initials': 'H', 'LastName': 'Ozdogan', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, University of Istanbul-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Vanderschueren', 'Affiliation': 'Clinical Department of General Internal Medicine, Research Department of Immunology, Microbiology and Transplantation, Laboratory for Clinical Infectious and Inflammatory Disorders, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marzan', 'Affiliation': ""Pediatrics Keck School of Medicine of USC, Children's Hospital Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'J Michelle', 'Initials': 'JM', 'LastName': 'Kahlenberg', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Immunology, Hepatology & Dermatology Franchise, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'De Benedetti', 'Affiliation': 'Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, Roma, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Koné-Paut', 'Affiliation': 'Université de Paris Sud-Saclay, Le Kremlin Bicêtre, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217419']
1195,32577871,Efficacy of cyanoacrylate in the prevention of delayed bleeding after endoscopic mucosal resection of large colorectal polyps: a pilot study.,"BACKGROUND


Postoperative bleeding is a common complication after endoscopic polypectomy, particularly after endoscopic mucosal resection (EMR) of large non-pedunculated polyps, despite prophylactic clipping can reduce its occurrence. Cyanoacrylate glue has recently been proposed as a useful tool in reducing bleeding in surgery because of its adhesive and haemostatic properties. The aim of this study is to evaluate the usefulness of endoscopic application of a modified cyanoacrylate glue in the prevention of early or delayed post EMR bleeding.
METHODS


This is a pilot study. Inclusion criteria were patients between 18 and 75 years old affected by sessile or flat colonic polyps larger than 2 cm. Patients enrolled in the study were randomized in two groups: group A (EMR) and group B (EMR with the application of 0.3 ml of N-butyl-2-cyanoacrylate + methacryloxysulfolane-Glubran 2®).
RESULTS


Fifteen patients in both group A and B were enrolled. There were no intraoperative complications but haemostatic clipping was necessary in 3 patients in each group because of active bleeding. Delayed (after 24 h) bleeding occurred in two patients (13.3%) in group A requiring hospital readmission and re-do endoscopy with apposition of haemostatic clips. No case of bleeding was recorded in group B (p = 0.48).
CONCLUSION


The results of this pilot study suggest a potential role of local spray application of Glubran®2 in reducing post-procedural bleeding.",2020,"No case of bleeding was recorded in group B (p = 0.48).
","['Fifteen patients in both group A and B were enrolled', 'Inclusion criteria were patients between 18 and 75\xa0years old affected by sessile or flat colonic polyps larger than 2\xa0cm', 'delayed bleeding after endoscopic mucosal resection of large colorectal polyps']","['cyanoacrylate', 'Cyanoacrylate glue', 'modified cyanoacrylate glue', 'endoscopic mucosal resection (EMR', 'group A (EMR) and group B (EMR with the application of 0.3\xa0ml of N-butyl-2-cyanoacrylate + methacryloxysulfolane-Glubran 2®', 'Glubran®']","['post-procedural bleeding', 'intraoperative complications', 'hospital readmission', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}]","[{'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0014035', 'cui_str': 'Enbucrilate'}, {'cui': 'C0964648', 'cui_str': 'glubran 2'}, {'cui': 'C0964647', 'cui_str': 'glubran'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3203457', 'cui_str': 'Procedural haemorrhage'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.0262898,"No case of bleeding was recorded in group B (p = 0.48).
","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Martines', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Picciariello', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Rigers', 'Initials': 'R', 'LastName': 'Dibra', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Trigiante', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'O Caputi', 'Initials': 'OC', 'LastName': 'Jambrenghi', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Chetta', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy.'}, {'ForeName': 'Donato Francesco', 'Initials': 'DF', 'LastName': 'Altomare', 'Affiliation': 'Department of Emergency and Organ transplantation, Surgical Unit ""M.Rubino"", Azienda Ospedaliero Universitaria Policlinico, Bari, Italy. donatofrancesco.altomare@uniba.it.'}]",International journal of colorectal disease,['10.1007/s00384-020-03678-9']
1196,32579807,Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.,"BACKGROUND


Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β 2 -agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking.
METHODS


In a 52-week, phase 3, randomized trial to evaluate the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very-severe COPD and at least one exacerbation in the past year, we assigned patients in a 1:1:1:1 ratio to receive twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide], a LAMA [18 μg of glycopyrrolate], and a LABA [9.6 μg of formoterol]) or one of two dual therapies (18 μg of glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol). The primary end point was the annual rate (the estimated mean number per patient per year) of moderate or severe COPD exacerbations, as analyzed in the modified intention-to-treat population with the use of on-treatment data only.
RESULTS


The modified intention-to-treat population comprised 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg-budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg-budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate-formoterol group (2120 patients), and 1.24 in the budesonide-formoterol group (2131 patients). The rate was significantly lower with 320-μg-budesonide triple therapy than with glycopyrrolate-formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide-formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P = 0.003). Similarly, the rate was significantly lower with 160-μg-budesonide triple therapy than with glycopyrrolate-formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide-formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P = 0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
CONCLUSIONS


Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate-formoterol or budesonide-formoterol. (Funded by AstraZeneca, ETHOS ClinicalTrials.gov number, NCT02465567.).",2020,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
","['patients with moderate-to-very-severe COPD and at least one exacerbation in the past year', 'Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', '8509 patients']","['LAMA', 'glycopyrrolate-formoterol', 'inhaled glucocorticoid', 'triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide', 'glycopyrrolate-formoterol or budesonide-formoterol', 'LABA [9.6 μg of formoterol', 'inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA', 'glycopyrrolate, and formoterol', 'glycopyrrolate', 'budesonide-formoterol', 'glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol']","['moderate or severe COPD exacerbations', 'incidence of confirmed pneumonia', 'annual rates of moderate or severe exacerbations', 'incidence of any adverse event', 'efficacy and safety', 'annual rate', 'rate of moderate or severe COPD exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.540992,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group.
","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'McLaren', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916046']
1197,32444133,Comparison of two methods for obtaining and transporting corneal samples in suspected infectious keratitis.,"BACKGROUND AND PURPOSE


The purpose of this study is to compare two alternative methods of collecting and transporting media for the diagnosis of corneal ulcers, as not all clinical settings have conventional culture materials and transport media available.
METHODS


In this open-label, prospective, comparative, and randomized study, patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth. The order of each collection method was randomized. The samples were processed by standard methods, comparing the positivity frequencies for both by parametric and nonparametric tests, according to normality criteria.
RESULTS


Corneal infiltrates from 40 eyes of 40 patients were analyzed. Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258). The overall growth rate of the two methods combined was not higher than with the swab alone. The results obtained with a swab were not influenced by the collection sequence (P=0.112); however, the positivity rate was significantly higher when the sample taken with the needle was performed first (P=0.046).
CONCLUSIONS


The single sample Eswab method of collection and transportation for the diagnosis of high risk corneal ulcers is a valid alternative and can be used in cases in which, for various reasons, there is no access to the full set of traditional culture materials.",2020,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"['patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth', 'Corneal infiltrates from 40 eyes of 40 patients were analyzed', 'suspected infectious keratitis']",['collecting and transporting media'],"['Culture positivity rate', 'positivity rate', 'overall growth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0972753', 'cui_str': 'Transport medium'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C1550050', 'cui_str': 'Amies transport medium'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0853336', 'cui_str': 'Infiltrate of cornea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0972753', 'cui_str': 'Transport medium'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",40.0,0.0360887,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chang-Sotomayor', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: meilinchangsotomayor@gmail.com.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Llorens Bellés', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: llorens.victor@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Latasiewicz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: martuska1111@gmail.com.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torras-Sanvicens', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: JTORRAS@clinic.cat.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Blanco-Domínguez', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: ire_blanco@hotmail.com.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sabater-Cruz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: noelia.sabater@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sainz-de-la-Maza', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: MSAINZ@clinic.cat.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Mestres', 'Affiliation': 'Microbiology Department Hospital Clínic de Barcelona, ISGlobal, Carrer de Villarroel, 170, 08036 Barcelona, Spain. Electronic address: JOBOSCH@clinic.cat.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Palma-Carvajal', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: fpalmac@gmail.com.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2019.10.010']
1198,32444619,Virtual reality clinical-experimental tests of compassion treatment techniques to reduce paranoia.,"Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = <0.0001, d = 1.4) and decreased in paranoia (group difference = -1.73, C.I. = -2.48; -0.98, p = <0.0001, d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.",2020,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","['Two-hundred individuals from the general population scoring highly for paranoia were recruited', 'Individuals repeatedly entered neutral virtual reality social environments']",['LKM'],"['paranoia', 'Change in compassion', 'self-compassion', 'compassion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",200.0,0.084631,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","[{'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. poppy.brown@psych.ox.ac.uk.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Scientific reports,['10.1038/s41598-020-64957-7']
1199,32444629,Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial.,"Minimally invasive surgery for inguinal hernia repair is advantageous in terms of return to usual activities and lower rates of chronic pain; however, it requires general anesthesia. This study sought to analyze the benefits of ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block) as a single anesthetic technique for endoscopic totally extraperitoneal (TEP) inguinal hernia repair with regard to postoperative pain, length of hospital stay, and hospital cost. A total of 46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair. In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia. Consequently, the former group showed a briefer median hospital stay (6 versus 24 hours, respectively). The anesthesia and hospital costs were also lower for the QL block group, with median reductions of 64.15% and 25%, respectively. QL block is a safe and effective option for patients undergoing TEP inguinal hernia repair, given the observed reduction in early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs.",2020,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"['46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received', 'Tep) Inguinal Hernia Repair', 'patients undergoing TEP inguinal hernia repair']","['ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block', 'general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair', 'Laparoscopic Totally Extraperitoneal', 'Minimally invasive surgery', 'QL block', 'endoscopic totally extraperitoneal (TEP) inguinal hernia repair']","['median pain score', 'Quadratus Lumborum Block', 'anesthesia and hospital costs', 'briefer median hospital stay', 'postoperative pain, length of hospital stay, and hospital cost', 'early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",46.0,0.130019,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"[{'ForeName': 'Murillo de Lima', 'Initials': 'ML', 'LastName': 'Favaro', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil. mlfavaro@prof.unisa.br.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Gabor', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Diogo Barros Florenzano', 'Initials': 'DBF', 'LastName': 'Souza', 'Affiliation': 'Professor of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Anderson Alcoforado', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Ana Luiza Castro', 'Initials': 'ALC', 'LastName': 'Milani', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Augusto Fontenelle', 'Initials': 'MAF', 'LastName': 'Ribeiro Junior', 'Affiliation': 'Full Professor of General Surgery at the University Santo Amaro, São Paulo, Brazil.'}]",Scientific reports,['10.1038/s41598-020-65604-x']
1200,32444670,A new approach to prevent cervical stenosis in postmenopausal women after loop electrosurgical excision procedure: a randomized controlled trial.,"To determine whether regular cervical dilatation is effective for preventing cervical stenosis, and to identify the associated risk factors, in postmenopausal women after LEEP. This was a prospective randomized clinical trial in postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019. Patients who met the study criteria were randomly allocated to three groups: control group (without any intervention), intervention group A (underwent cervical dilatation at the 3 rd , 5 th , and 8 th  week after LEEP) and intervention group B (underwent cervical dilatation at the 4 th , 8 th , and 12 th  week after LEEP). A colposcopic follow-up examination was conducted at 6 months after LEEP to determine the incidence of cervical stenosis. A total of 404 postmenopausal women were found to be finally eligible for the study. The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group B. We found regular dilatation after LEEP in postmenopausal women can prevent cervical stenosis. Further, the 3rd, 5th, and 8th weeks after LEEP are optimal time points. Finally, LEEP frequency and resection depth are significant risk factors and can be used to screen postmenopausal women at risk for cervical stenosis after LEEP.",2020,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","['screen postmenopausal women at risk for cervical stenosis after LEEP', 'Patients who met the study criteria', 'postmenopausal women after loop electrosurgical excision procedure', 'postmenopausal women', '404 postmenopausal women were found to be finally eligible for the study', 'postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019', 'postmenopausal women after LEEP']","['regular cervical dilatation', 'control group (without any intervention), intervention group A (underwent cervical dilatation']",['rate of cervical stenosis'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}]",404.0,0.0439457,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhunan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. dr.wudan@163.com.'}]",Scientific reports,['10.1038/s41598-020-65170-2']
1201,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8']
1202,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR).
OBJECTIVE


We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial.
METHOD


The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL.
RESULTS


We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01).
CONCLUSIONS


Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004']
1203,32567654,"Impact of Succinct Training on Open Cricothyrotomy Performance: A Randomized, Prospective, Observational Study of U.S. Army First Responders.","INTRODUCTION


Primary airway failure has become the second most common cause of potentially survivable battlefield fatality. Cricothyrotomy is taught to all U.S. military providers as a means of securing an airway in extremis. However, retrospective studies show that cricothyrotomy failure rates for U.S. military first responders performing the procedure in combat is 33%. Our hypothesis was that these rates could be improved.
MATERIALS AND METHODS


We conducted a randomized, prospective, observational study to evaluate the effects of inexpensive, succinct training on open cricothyrotomy performance by studying two unique U.S. Army First Responder participant groups. One participant group consisted of regular U.S. Army Medics (68 Ws). The second group was Special Operations Combat Medics. We evaluated both groups' baseline ability to correctly perform a cricothyrotomy and then randomly assigned individuals within each group to either a training or practice group.
RESULTS


The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
CONCLUSION


With one manikin, a qualified trainer, and $35 worth of expendable supplies, 10 medics could be trained in the procedure in just 2-3 hours. Our study suggests that this simple intervention has the potential to significantly improve U.S. Army First Responders' ability to correctly perform an open cricothyrotomy and drastically decrease the time needed to perform this lifesaving procedure correctly, possibly saving one in four potentially survivable combat casualties suffering from airway compromise.",2020,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
",[],"['training or practice group', 'regular U.S. Army Medics', 'Cricothyrotomy', 'Succinct Training', 'inexpensive, succinct training']","['procedural success rates', 'Open Cricothyrotomy Performance', 'average time-to-correct-placement']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0179072,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
","[{'ForeName': 'Kurtis L', 'Initials': 'KL', 'LastName': 'Muller', 'Affiliation': 'Special Warfare Medical Group (Airborne) 1975 Combat Medic Rd, Fort Bragg NC 28310.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Facciolla', 'Affiliation': '1st Special Forces Command (Airborne) 1625 Reilly Rd, Fort Bragg, NC 28310.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Monti', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Cronin', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}]",Military medicine,['10.1093/milmed/usaa035']
1204,32444306,"Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study.","BACKGROUND


In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902). Here, we examine the safety and efficacy of dupilumab in the subpopulation of Japanese patients who participated in QUEST (n = 114; 6%).
METHODS


Endpoints assessed were annualized severe exacerbation rates and the effect of treatment over the 52-week treatment period on FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation.
RESULTS


In Japanese patients, dupilumab 200 and 300 mg every 2 weeks vs matched placebo reduced severe asthma exacerbation rates by 44% (P = 0.33) and 75% (P = 0.03), respectively, and improved FEV 1  at Week 12 by 0.20 L (P = 0.05) and 0.17 L (P = 0.12). FEV 1  improvements were rapid (by Week 2) and sustained throughout treatment. Significant and/or numerical improvements vs placebo in asthma control and quality of life were also observed throughout treatment. For each endpoint, greater efficacy was observed in patients with elevated baseline levels of type 2 inflammatory biomarkers (blood eosinophils or FeNO). Dupilumab treatment significantly reduced levels of FeNO and total IgE, but not blood eosinophils.
CONCLUSIONS


In this subanalysis of QUEST, the efficacy and safety of dupilumab in Japanese patients was comparable to that observed in the overall intention-to-treat population, suggesting no variability in efficacy on the basis of Japanese ethnicity. (Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov number: NCT02414854).",2020,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","['Japanese patients who participated in QUEST (n\xa0=\xa0114; 6', 'Japanese patients with uncontrolled, moderate-to-severe asthma', 'Japanese patients']","['dupilumab', 'placebo']","['annualized severe exacerbation rates', 'Dupilumab efficacy and safety', 'severe asthma exacerbation rates', 'FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation', 'levels of FeNO and total IgE', 'efficacy and safety', 'safety and efficacy', 'asthma control and quality of life', 'reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.10339,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Kindai University Hospital, Osaka, Japan. Electronic address: tohda@med.kindai.ac.jp.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Yokohama City Minato Red Cross Hospital, Yokohama City, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Allergy Center, National Hospital Organization Mie National Hospital, Tsu, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.04.002']
1205,32446842,Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.,"PURPOSE


To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.
DESIGN


Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).
PARTICIPANTS


Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.
METHODS


A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT.
MAIN OUTCOME MEASURES


We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC.
RESULTS


A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001).
CONCLUSIONS


Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.",2020,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","['22 patients undergoing', 'A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC', 'eyes treated with cooling anesthesia', 'Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included']","['standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia', 'Ultra-Rapid Cooling Anesthesia', 'bilateral IVT', 'cooling anesthesia']","['Mild, transient adverse events', 'Mean VAS pain scores', 'Mean±SEM pain scores', 'toxicity', 'mean±standard error of the mean (SEM) VAS pain scores', 'Total mean±SEM procedure time', 'Subjective pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2237660', 'cui_str': 'Wet Macular Degeneration'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",22.0,0.0922038,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","[{'ForeName': 'Cagri G', 'Initials': 'CG', 'LastName': 'Besirli', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. Electronic address: cbesirli@med.umich.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University School of Medical, Palo Alto, California; iRenix Medical, Inc., Palo Alto, California.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Zacks', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Pipe', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan; Department of Electrical Engineering and Computer Science, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Shah', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.001']
1206,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION


Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease.
METHODS


In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints.
DISCUSSION


The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data.
TRIAL REGISTRATION


ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2']
1207,32446158,Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.,"BACKGROUND


Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms.
METHOD


Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder.
MAIN RESULTS


The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
DISCUSSION AND CONCLUSION


We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.",2020,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","['panic disorder', 'patients with panic symptoms', 'Forty-one patients']","['mobile app-based interactive CBT', 'chatbot group (n\u202f=\u202f21) or control group', 'mobile app-based interactive cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Mobile app-based interactive CBT']","['severity of panic symptoms', 'severity of panic disorder', 'control helplessness score', 'social phobia score']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",41.0,0.0195038,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group.
","[{'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jaejkim@yonsei.ac.kr.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104171']
1208,32447224,Shorter sleep duration is associated with lower GABA levels in the anterior cingulate cortex.,"BACKGROUND


Alterations in the levels of gamma-aminobutyric acid (GABA) and glutamate + glutamine (Glx), which are major inhibitory and excitatory neurotransmitters, respectively, are frequently associated with insomnia. Previous reports also suggested the involvement of the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration. In the current study, we investigated whether the GABA and Glx levels were altered in the ACC/mPFC in subclinical insomnia while focusing on the sleep duration.
METHODS


We examined levels of GABA and Glx in the ACC/mPFC of the brain with magnetic resonance spectroscopy in 166 individuals with subjective sleep complaints but without a diagnosis of insomnia. Participants were divided into two groups according to sleep duration (≥6 h/night: n = 79 vs. < 6 h/night: n = 74), which was measured using a wrist-worn actigraphy. Working memory function and overall subjective sleep quality were assessed with a computerized neuropsychological test and self-report questionnaire, respectively.
RESULTS


GABA levels in the ACC/mPFC were lower in the shorter sleep duration group relative to the longer sleep duration group (t = -2.21, p = 0.03). Glx levels did not differ between the two groups (t = -0.20, p = 0.84). Lower GABA levels were associated with lower spatial working memory performance in the shorter sleep duration group (β = -0.21, p = 0.03), but not the longer sleep duration group (β = 0.04, p = 0.72).
CONCLUSION


Shorter sleep duration was associated with lower GABA levels in the ACC/mPFC. These findings may provide insight into the underlying mechanisms of impaired working memory function related to insomnia and sleep loss.",2020,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).",['166 individuals with subjective sleep complaints but without a diagnosis of insomnia'],['magnetic resonance spectroscopy'],"['Shorter sleep duration', 'anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration', 'Glx levels', 'mPFC', 'Working memory function and overall subjective sleep quality', 'GABA levels', 'GABA and Glx levels', 'Lower GABA levels', 'spatial working memory performance']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",166.0,0.0321215,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).","[{'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Ilhyang', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; F.M. Kirby Research Center for Functional Brain Imaging, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jinsol', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: jungyoon.kimm@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.018']
1209,32247794,Subperiosteal versus Subdural Drain After Burr-hole Drainage Under Blood Thinners: A Subanalysis of the cSDH-Drain RCT.,"OBJECTIVE


The chronic subdural hematoma (cSDH)-Drain trial compared recurrence rates and clinical outcome associated with the use of subperiosteal drain (SPD) and subdural drain (SDD) after burr-hole drainage for cSDH. This subgroup analysis aimed to determine whether one drain type is preferable for patients treated with platelet inhibitors (PI) or anticoagulants (AC).
METHODS


This subanalysis included 133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial. For these patients the association between the drain type used and recurrence rates, mortality, as well as clinical outcome at 6 weeks and 12 months follow-up were analyzed using a logistic regression analysis model. Additionally, recurrence rates, clinical outcome, and mortality were assessed for each PI or AC type separately.
RESULTS


The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36). Outcome measurements and mortality did not differ significantly between both groups at 6-week and 12-month follow-up. In addition, there was no statistically significant association between drain type and recurrence rate or mortality when comparing data for each PI or AC type. At 24 hours postoperatively, significantly more patients under phenprocoumon and natrium-dalteparin had a Glasgow Coma Scale score between 13 and 15 in the SDD group compared with the SPD group (P = 0.006), whereaas at 6-week follow-up significantly more patients in the SDD group treated with ASA had a good modified Rankin scale score (P = 0.01). At 12 months, no significant difference in outcome measurements was seen for all PI and AC types.
CONCLUSIONS


In patients treated with PI or AC, the insertion of SPD after burr-hole drainage of cSDH showed comparable recurrence, mortality, and long term outcome rates when compared with SDD.",2020,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","['133 patients treated with PI/AC of the 220 patients from the preceding cSDH-Drain trial', 'After Burr-hole Drainage Under Blood Thinners']","['Subperiosteal versus Subdural Drain', 'ASA', 'subperiosteal drain (SPD) and subdural drain (SDD', 'cSDH-Drain RCT', 'platelet inhibitors (PI) or anticoagulants (AC']","['good modified Rankin scale score', 'Glasgow Coma Scale score', 'recurrence, mortality', 'recurrence rates, mortality', 'mortality', 'recurrence rates', 'recurrence rates, clinical outcome, and mortality', 'drain type and recurrence rate or mortality']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",220.0,0.201965,"The insertion of SPD was associated with 7.35% recurrence rates compared to 13.85% with SDD in patients treated with PI or AC (OR 0.41, 95% CI 0.06-2.65, P = 0.36).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kamenova', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lutz', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland; Department of Neurosurgery, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schaedelin', 'Affiliation': 'Clinical Trial Unit, University of Basel, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jehuda', 'Initials': 'J', 'LastName': 'Soleman', 'Affiliation': 'Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland. Electronic address: jehuda.soleman@gmail.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.134']
1210,32453167,Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND


For endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anaesthesia, both rigid bronchoscopy and laryngeal masks (LMAs) with superimposed high-frequency jet ventilation can be used. Despite the fact that in Europe rigid bronchoscopy for EBUS-TBNA is still widely used, an increasing number of centres use jet ventilation via the LMA for this procedure. To our knowledge no clinical trials have ever been made to compare these two methods. This trial aimed to evaluate whether patients recover from the procedure more quickly when a LMA is used for ventilation compared with rigid bronchoscopy where muscle relaxants and deep anaesthesia are required.
OBJECTIVES


We wanted to test the hypothesis that there is no difference in the postoperative recovery of patients in the postanaesthesia care unit (PACU) after EBUS-TBNA with jet ventilation via a rigid bronchoscope and a LMA. Secondary outcomes were the difference of duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups.
DESIGN


Prospective randomised single blinded two centre controlled trial.
SETTING


Two centres in Austria participated. Patients were enrolled from December 2016 until January 2018.
PATIENTS


Ninety patients for elective EBUS-TBNA were enrolled and assigned to one of two intervention groups. Two patients were excluded before and eleven patients were excluded after EBUS-TBNA. Seventy-seven were analysed.
INTERVENTIONS


Patients assigned to group 1 were ventilated with a LMA; those assigned to group 2 were ventilated via a rigid bronchoscope. Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU were recorded.
MAIN OUTCOME MEASURES


The primary endpoint was an integral over time of a modified Aldrete score. Secondary endpoints were the durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome.
RESULTS


We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes. Vital signs remained stable and in an equal range in both groups. There were no differences in the mean effect site propofol concentration and the peak ultiva rates.
CONCLUSION


EBUS-TBNA under general anaesthesia using a LMA with SHJV is equal to rigid bronchoscopy with superimposed high-frequency jet ventilation for the variables analysed.
TRIAL REGISTRATION


ISRCTN (ISRCTN58911367).",2020,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","['Patients were enrolled from December 2016 until January 2018', 'Seventy-seven were analysed', 'Ninety patients for elective EBUS-TBNA', 'Two patients were excluded before and eleven patients were excluded after EBUS-TBNA', 'Two centres in Austria participated']","['ventilated via a rigid bronchoscope', 'endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'LMA with SHJV', 'endobronchial ultrasound-guided transbronchial needle aspiration', 'Infraglottic versus supraglottic jet-ventilation', 'LMA']","['Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU', 'mean effect site propofol concentration and the peak ultiva rates', 'integral over time of a modified Aldrete score', 'durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome', 'duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0594510', 'cui_str': 'Ultiva'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",2.0,0.127212,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fritze', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Base', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wasserscheid', 'Affiliation': ''}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Wolfram', 'Affiliation': ''}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Koinig', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hackner', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lambers', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schweiger', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Errhalt', 'Affiliation': ''}, {'ForeName': 'Mir A', 'Initials': 'MA', 'LastName': 'Hoda', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001220']
1211,32450154,"After ten years of follow-up, no difference between supportive care plus immunosuppression and supportive care alone in IgA nephropathy.","The randomized, controlled STOP-IgAN trial in patients with IgA nephropathy (IgAN) and substantial proteinuria showed no benefit of immunosuppression added on top of supportive care on renal function over three years. As a follow-up we evaluated renal outcomes in patients over a follow-up of up to ten years in terms of serum creatinine, proteinuria, end-stage kidney disease (ESKD), and death. The adapted primary endpoint was the time to first occurrence of a composite of death, ESKD, or a decline of over 40% in the estimated glomerular filtration rate (eGFR) compared to baseline at randomization into STOP-IgAN. Data were analyzed by Cox-regression models. Follow-up data were available for 149 participants, representing 92% of the patients originally randomized. Median follow-up was 7.4 years (inter quartile range 5.7 to 8.3 years). The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92). ESKD occurred in 17 of the patients with supportive care and in 20 of the patients with additional immunosuppression. Additionally, the rates of eGFR loss over 40% and annual eGFR loss did not differ between groups. Two patients died with supportive care and three with additional immunosuppression. Thus, within the limitations of a retrospective study, over a follow-up of up to ten years, and using an adapted primary endpoint, we failed to detect differences in key clinical outcomes in IgAN patients randomized to receive added immunosuppression on top of supportive care versus supportive care alone.",2020,The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92).,"['149 participants, representing 92% of the patients originally randomized', 'Two patients died with supportive-care and three with additional immunosuppression', 'patients with IgA nephropathy (IgAN) and substantial proteinuria showed no benefit of immunosuppression added on top of supportive care on renal function over three years']","['additional immunosuppression', 'added immunosuppression on top of supportive care versus supportive care alone']","['rates of eGFR loss', 'serum creatinine, proteinuria, end-stage kidney disease (ESKD), and death', 'ESKD', 'annual eGFR loss', 'time to first occurrence of a composite of death, ESKD, or a decline of over 40% in the estimated glomerular filtration rate (eGFR']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",149.0,0.0959926,The primary endpoint was reached in 36 of 72 patients randomized to supportive care and 35 of 77 patients randomized to additional immunosuppression (hazard ratio 1.20; 95% confidence interval 0.75 to 1.92).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauen', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fitzner', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eitner', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany; Bayer AG, Kidney Diseases Research, Wuppertal, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology and Renal Center Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zeier', 'Affiliation': 'Department of Nephrology and Renal Center Heidelberg, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Otte', 'Affiliation': 'Internal Medicine D, Department of Nephrology, Hypertension and Rheumatology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Panzer', 'Affiliation': 'Division of Nephrology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Budde', 'Affiliation': 'Department of Nephrology, Charité Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Benck', 'Affiliation': 'Department of Medicine V, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Mertens', 'Affiliation': 'Department of Nephrology and Hypertension, Diabetes and Endocrinology, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Kuhlmann', 'Affiliation': 'Medical Clinic III, Central Hospital Bremen, Bremen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Clinic for Nephrology and Rheumatology, University Medical Center Goettingen, Goettingen, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Vielhauer', 'Affiliation': 'Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, LMU München, Munich, Germany.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center Munich-Schwabing and Department of Medicine IV, University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen, Germany. Electronic address: jfloege@ukaachen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.04.046']
1212,32452085,Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): results in the pre-specified subgroup with heart failure.,"AIMS


The AMBER trial demonstrated that concomitant use of patiromer enabled the more persistent use of spironolactone by reducing the risk of hyperkalaemia in patients with resistant hypertension and advanced chronic kidney disease. We report herein the pre-specified subgroup analysis in patients with heart failure (HF).
METHODS AND RESULTS


Participants were randomly assigned (1:1) to receive either placebo or patiromer (8.4 g once daily), in addition to open-label spironolactone (starting at 25 mg once daily) and their baseline blood pressure medications. Dose titrations were permitted after 1 week for patiromer/placebo and after 3 weeks for spironolactone. The primary endpoint was the between-group difference at week 12 in the proportion of patients on spironolactone. Efficacy endpoints and safety were assessed in all randomized patients (intention to treat). A total of 295 patients were enrolled, of whom 132 (45%) had HF. In the HF subgroup, 68.1% of patients receiving placebo remained on spironolactone at week 12, compared with 84.1% of patients receiving patiromer (P = 0.0504). The reason for discontinuation from spironolactone use was hyperkalaemia in the majority of both groups. There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
CONCLUSIONS


Consistent with the overall AMBER trial results, this pre-specified subgroup analysis in patients with HF, resistant hypertension and advanced chronic kidney disease demonstrated that patiromer enabled more persistent use of spironolactone by reducing the risk of hyperkalaemia.",2020,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","['patients with resistant hypertension and chronic kidney disease', 'Participants', 'A total of 295 patients were enrolled, of whom 132 (45%) had HF', 'patients with resistant hypertension and advanced chronic kidney disease', 'patients with heart failure (HF']","['placebo or patiromer (8.4\xa0g once daily), in addition to open-label spironolactone', 'spironolactone', 'placebo']","['Efficacy endpoints and safety', 'risk of hyperkalaemia', 'AMBER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045522', 'cui_str': 'patiromer'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0242864', 'cui_str': 'Amber'}]",295.0,0.129969,"There was no significant interaction between the subgroups with HF and without HF (P = 0.8085) for the primary endpoint.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Science University College London (UCL) and National Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Martha R', 'Initials': 'MR', 'LastName': 'Mayo', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Arthur', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ackourey', 'Affiliation': 'Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",European journal of heart failure,['10.1002/ejhf.1860']
1213,32438817,Effectiveness Comparison of Dexmedetomidine and Remifentanil for Perioperative Management in Patients Undergoing Endoscopic Sinus Surgery.,"BACKGROUND


For patients undergoing endoscopic sinus surgery, intranasal injection of epinephrine can cause acute increases in heart rate and blood pressure.
OBJECTIVE


Among the drugs for reducing hyperdynamic effects, dexmedetomidine and remifentanil are expected to blunt the acute hemodynamic responses after intranasal injection of epinephrine. Our study compared a difference in the 2 drugs in their abilities to blunt the hemodynamic responses in intraoperative period and postoperative profile.
METHODS


In this study, the patients were randomly divided into the dexmedetomidine and remifentanil groups. During the intraoperative period, the hemodynamic values were recorded. The surgical condition was assessed by a single surgeon. During the postoperative period, hemodynamic values, sedation scale score, and pain score were recorded.
RESULT


No significant differences in hemodynamic variables were found between the groups before and after intranasal injection of epinephrine. Comparison of the group mean values before endotracheal intubation revealed that the blood pressure values in the remifentanil group were significantly lower than those in the dexmedetomidine group. At 2 minutes after endotracheal intubation, blood pressure and heart rate values in the remifentanil group were significantly lower than those in the dexmedetomidine group. The sedation score was significantly lower in the dexmedetomidine group on arrival and at 30 minutes after arrival at the postanesthetic care unit ( P  < .001 and  P  = .001, respectively). At 30 and 60 minutes after the operation, the pain scores were significantly lower in the dexmedetomidine group ( P  = .015 and  P  = .001, respectively).
CONCLUSION


Dexmedetomidine had better postoperative sedative and analgesic effects than remifentanil for patients undergoing endoscopic sinus surgery in this study. Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables. Remifentanil was superior to dexmedetomidine in inducing hypotension during endotracheal intubation.",2020,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","['patients undergoing endoscopic sinus surgery', 'Patients Undergoing Endoscopic Sinus Surgery']","['dexmedetomidine and remifentanil', 'Remifentanil', 'Dexmedetomidine', 'Dexmedetomidine and Remifentanil', 'remifentanil', 'epinephrine', 'dexmedetomidine']","['pain scores', 'heart rate and blood pressure', 'blood pressure and heart rate values', 'postoperative sedative and analgesic effects', 'blood pressure values', 'sedation score', 'acute hemodynamic responses', 'hemodynamic values, sedation scale score, and pain score', 'hypotension', 'hemodynamic variables', 'hemodynamic values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0436728,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","[{'ForeName': 'Hyub', 'Initials': 'H', 'LastName': 'Huh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Jun', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Seong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hag', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Zhoo', 'Initials': 'SZ', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang Eun', 'Initials': 'JE', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}]",American journal of rhinology & allergy,['10.1177/1945892420927291']
1214,32443744,Effectiveness of A Pilates Training Program on Cognitive and Functional Abilities in Postmenopausal Women.,"The purpose of this study was to determine the effects of a Pilates exercises program on the cognitive and physical functioning of older Spanish women. This study is a randomized clinical trial; a total of 110 women aged ≥60 years were initially allocated to either a Pilates group (PG, n = 55), who underwent a 12-week Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention. Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test) were assessed before and immediately after the intervention period. The main findings of this study suggest that women in the PG (within-group differences) experienced improvements across all the variables examined except for global cognitive function. When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test). In conclusion, our results suggest that Pilates has the potential to improve both cognitive and functional abilities among Spanish women aged 60 years and over.",2020,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","['Spanish women aged 60 years and over', 'Postmenopausal Women', '110 women aged ≥60 years', 'older Spanish women']","['Pilates Training Program', 'Pilates exercises program', 'Pilates exercise program, or to a control group (CG, n = 55), who did not receive any intervention']","['cognitive and functional abilities', 'global cognitive function and functional flexibility (Back Scratch Test', 'global cognitive function', 'Global cognitive function (Mini-Mental State Examination), verbal fluency (Isaacs test), executive function (Trail Making Test), functional flexibility (Back Scratch Test and Chair Sit-and-Reach Test), and lower-body strength (30 s Chair-Stand Test', 'Cognitive and Functional Abilities', 'cognitive and physical functioning']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0430562', 'cui_str': 'Scratch test'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",110.0,0.0263371,"When compared with the CG (between-group differences), our analysis revealed significant benefits in the PG for all measures except for global cognitive function and functional flexibility (Back Scratch Test).","[{'ForeName': 'Patricia Alexandra', 'Initials': 'PA', 'LastName': 'García-Garro', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Hita-Contreras', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'José Daniel', 'Initials': 'JD', 'LastName': 'Jiménez-García', 'Affiliation': 'Department of Teaching Physical Education, Fine Arts and Music, University of Cádiz, 11003 Cádiz, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cruz-Díaz', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103580']
1215,32449213,"Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.","OBJECTIVE


To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT 1F  ) receptor agonist developed for the acute treatment of migraine, on simulated driving.
METHODS


Healthy adult volunteers enrolled in two randomized, placebo and active comparator-controlled, crossover studies. Study 1 (N = 90) tested lasmiditan (50-, 100-, 200-mg), alprazolam (1-mg), and placebo at 1.5 hr post-dose. Study 2 (N = 68) tested lasmiditan (100-, 200-mg), diphenhydramine (50-mg, administered 2 hr pre-assessments), and placebo at 8, 12 and 24 hr post-dose. Driving performance was assessed using a validated driving simulator employing a 100 km driving scenario. Standard deviation of lateral position (SDLP), a measure of lane position control, was the primary endpoint.
RESULTS


Assay sensitivity was confirmed by increased SDLP for active comparators at 1.5- and 8-hr time points. Lasmiditan doses showed significant driving impairment versus placebo at 1.5 hr post-dose. Lasmiditan doses were non-inferior to placebo at 8 hr. Driving impairment was concentration-dependent at 1.5 hr but not at 8 hr. Common adverse events were central nervous system-related and mild-to-moderate in severity.
CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",2020,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",['Healthy adult volunteers enrolled in two randomized'],"['lasmiditan', 'lasmiditan ', 'alprazolam (1-mg), and placebo', 'lasmiditan (100-, 200-mg), diphenhydramine', 'placebo']","['Driving performance', 'simulated driving performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]",,0.377978,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Wilbraham', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ellen B', 'Initials': 'EB', 'LastName': 'Dennehy', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Berg', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}]",Human psychopharmacology,['10.1002/hup.2732']
1216,32448711,Video Education to Improve Preoperative Anxiety in the Bariatric Surgical Patient: A Quality Improvement Project.,"PURPOSE


Evidence supports that providing preoperative education using an audiovisual format is an effective method to reduce anxiety in the surgical patient. The purpose of this quality improvement project was to evaluate the effect of viewing a video tour of the perioperative division had on patient-perceived preoperative anxiety.
DESIGN


A quasi-experimental design using a pre-post survey method of two individual groups.
METHODS


Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment. Thirty patients in the comparison group received preoperative education with the current process of written and verbal instructions. Thirty patients in the intervention group received education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division. A paired sample t test was used to compare VAS-A results of the comparison and intervention groups.
FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.",2020,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","['Thirty patients in the intervention group received', 'patients having bariatric surgery', 'Bariatric Surgical Patient', 'Sixty bariatric surgery patients completed a visual analog scale for anxiety (VAS-A), consisting of 10 items, on arrival and at the end of their preassessment appointment']","['Video Education', 'education with written and verbal instructions as well as inclusion of an informational video tour of the perioperative division', 'preoperative education with the current process of written and verbal instructions']","['anxiety levels', 'preoperative anxiety', 'self-perceived anxiety', 'Preoperative Anxiety']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0276817,"FINDINGS


Data supported that bariatric patients who received only verbal and written instructions preoperatively had a statistically significant reduction in anxiety levels in five of 10 items on the VAS-A. Bariatric patients who received education with verbal and written instructions, as well as inclusion of the informational video tour, had a statistically significant reduction in self-perceived anxiety in 9 of 10 items on the VAS-A.
CONCLUSIONS


Data supported that the addition of an audiovisual component in the form of an informational tour of the perioperative division is an effective method to reduce perceived preoperative anxiety in patients having bariatric surgery.","[{'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Helms', 'Affiliation': 'Perioperative Services, Reading Hospital/Tower Health, West Reading, PA. Electronic address: lori.helms@towerhealth.org.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.012']
1217,32456048,Effect of Plyometric versus Ankle Stability Exercises on Lower Limb Biomechanics in Taekwondo Demonstration Athletes with Functional Ankle Instability.,"BACKGROUND


This study aimed to compare the effects of plyometric and ankle stability exercises on the dynamic balance and lower limb kinematic and kinetic parameters of Taekwondo demonstration athletes with functional ankle instability.
METHODS


Fourteen subjects participated in this study and were randomly divided into two groups: a plyometric exercise group ( n  = 7) and an ankle stability exercise group ( n  = 7). Exercises were performed twice a week for 8 weeks. A Y-balance test was used to measure dynamic balance, and a motion analysis system and force plate were used to collect kinematic and kinetic parameters during single-leg drop landing. A paired t-test was used for intragroup comparisons, and an independent t-test was used for intergroup comparisons.
RESULTS


In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05). The plyometric exercise group decreased their ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion ( p  < 0.05). In contrast, the stability exercise increased their ankle plantar flexion at initial contact ( p  < 0.05).
CONCLUSIONS


The plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing. This study suggests that the application of plyometric exercises in ankle rehabilitation would improve stability and shock absorption and help prevent injuries during Taekwondo demonstrations.",2020,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05).","['Taekwondo Demonstration Athletes with Functional Ankle Instability', 'Fourteen subjects participated in this study', 'Taekwondo demonstration athletes with functional ankle instability']","['plyometric and ankle stability exercises', 'Plyometric versus Ankle Stability Exercises', 'plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing', 'plyometric exercise group ( n  = 7) and an ankle stability exercise group', 'plyometric exercises', 'plyometric exercise']","['stability exercise increased their ankle plantar flexion', 'ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion', 'dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement', 'stability and shock absorption']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0576206', 'cui_str': 'Stability of ankle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",14.0,0.0237313,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p  < 0.05).","[{'ForeName': 'Ha Min', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103665']
1218,32444309,Slow low-dose oral immunotherapy: Threshold and immunological change.,"BACKGROUND


We examined the feasibility, efficacy and safety of slow low-dose oral immunotherapy (SLOIT) for egg, milk, wheat allergies, with accepted severity-stratified initial and maintenance doses.
METHODS


Children with food allergies defined by low-dose oral food challenges (LD-OFCs) to hen's egg (cumulative protein dose up to 983 mg, n = 133), cow's milk (287 mg, n = 50), and wheat (226 mg, n = 45) were recruited. Participants were divided into two groups [SLOIT and control (complete avoidance]) based on their preferences. Participants who selected SLOIT were instructed to take the safe dose daily, with monthly increases, aiming to increase the dose by 10 times in one year. The primary outcome was the proportion of participants who passed the LD-OFCs following 1 year of therapy.
RESULTS


The participants in SLOIT group ingested their antigen 92.9% of the therapy's day on average. The proportion of participants who passed LD-OFCs was 35.9% (61/170) in the SLOIT group and 8.7% (4/46) in the control group (P < .001); no large differences were observed among allergens. Among the subjects who failed LD-OFCs, the median change in the total dose in the LD-OFC was 235% (interquartile range: 100%-512%) in the SLOIT group and 100% (42%-235%) in the control group (P < .001). Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
CONCLUSIONS


SLOIT showed significant feasibility, efficacy and safety, providing a promising option to manage patients with severe food allergies.",2020,"Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
","['Participants who selected SLOIT', ""Children with food allergies defined by low-dose oral food challenges (LD-OFCs) to hen's egg (cumulative protein dose up to 983\xa0mg, n\xa0=\xa0133), cow's milk (287\xa0mg, n\xa0=\xa050), and wheat (226\xa0mg, n\xa0=\xa045) were recruited"", 'patients with severe food allergies']","['slow low-dose oral immunotherapy (SLOIT', 'Slow low-dose oral immunotherapy', 'SLOIT']","['feasibility, efficacy and safety', 'proportion of participants who passed LD-OFCs', 'Provoked allergic symptoms', 'proportion of participants who passed the LD-OFCs']","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",45.0,0.0801129,"Provoked allergic symptoms were observed in only 0.58% (280/48,486) per programmed intake and approximately 50% of the SLOIT group did not experience any obvious allergic symptoms throughout therapy.
","[{'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Sugiura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan. Electronic address: bee_jayz@hotmail.com.""}, {'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Makino', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Furuta', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Takasato', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Kando', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan.""}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.03.008']
1219,32444401,Self-titration of inhaled corticosteroid and β 2 -agonist in response to symptoms in mild asthma: a pre-specified analysis from the PRACTICAL randomised controlled trial.,"INTRODUCTION


In mild asthma, as-needed budesonide-formoterol is superior or noninferior to maintenance budesonide plus as-needed short-acting β 2 -agonist in reducing severe exacerbations. In this pre-specified analysis, we investigated patterns of inhaled corticosteroid (ICS) and β 2 -agonist use in PRACTICAL, a randomised controlled trial.
METHODS


Participants were randomised 1:1 to as-needed budesonide-formoterol (200/6 μg Turbuhaler, one actuation) or maintenance budesonide (200 μg Turbuhaler, one actuation twice a day) with as-needed terbutaline (250 μg, two actuations) for 52 weeks. 110 participants had electronic monitors attached to their study inhalers which captured the time and date of every actuation. Key outcome measures were patterns of ICS and β 2 -agonist use. One actuation of budesonide-formoterol was considered to be an equivalent bronchodilator dose as two actuations of terbutaline.
RESULTS


Participants randomised to as-needed budesonide-formoterol had more days with no ICS use compared with maintenance budesonide (median total days of no use 156  versus  22 days, respectively), lower median daily budesonide dose (164  versus  328 μg, respectively) and a greater median number of days of ≥4 budesonide actuations (4  versus  1 days, respectively). Participants randomised to as-needed budesonide-formoterol took higher equivalent doses of β 2 -agonist both overall (median number of actuations 0.8  versus  0.3 per day, respectively) and in response to worsening asthma (total number of ""overuse days"" of >8 or >16 actuations of budesonide-formoterol or terbutaline 33  versus  10 days, respectively).
CONCLUSIONS


The timing of ICS dose when self-titrated to β 2 -agonist use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed β 2 -agonist.",2020,"use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta 2 -agonist.","['Participants', 'mild asthma ']","['agonist', 'maintenance budesonide', 'terbutaline', 'inhaled corticosteroid and beta 2 -agonist', 'budesonide-formoterol or terbutaline 33  versus  10 respectively', 'inhaled corticosteroid (ICS', 'budesonide-formoterol']","['median number of days of ≥4 budesonide actuations', 'severe exacerbations', 'patterns of ICS and beta']","[{'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.646451,"use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta 2 -agonist.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sparks', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hall', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vohlidkova', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Dept of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Dept of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00170-2020']
1220,32452659,"Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.","Clopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75-mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference-scaled average bioequivalence method. An open-label, randomized, 3-sequence and 3-period crossover (3×3), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high-precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of C max  and AUC 0-t  were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.",2020,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","['Fed and Fasted Conditions', 'Healthy Chinese Volunteers']","['clopidogrel hydrogen sulfate formulations', 'Clopidogrel Hydrogen Sulfate Tablet', 'Clopidogrel']","['geometric least squares mean ratios of C max  and AUC 0-t', 'Clopidogrel concentration of plasma samples', 'geometric least-squares mean ratios of peak concentration (C max  ) and area under the concentration-time curve (AUC 0-t  ']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0772326', 'cui_str': 'Clopidogrel bisulfate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",66.0,0.0275802,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.804']
1221,32580207,Metabolic activity in subcallosal cingulate predicts response to deep brain stimulation for depression.,"Subcallosal cingulate (SCC) deep brain stimulation (DBS) is a promising therapy for treatment-resistant depression (TRD), but response rates in open-label studies were not replicated in a large multicenter trial. Identifying biomarkers of response could improve patient selection and outcomes. We examined SCC metabolic activity as both a predictor and marker of SCC DBS treatment response. Brain glucose metabolism (CMRGlu) was measured with [18F] FDG-PET at baseline and 6 months post DBS in 20 TRD patients in a double-blind randomized controlled trial where two stimulation types (long pulse width (LPW) n = 9 and short pulse width (SPW) n = 11) were used. Responders (n = 10) were defined by a ≥48% reduction in Hamilton Depression Rating Scale scores after 6 months. The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%). First, differences in SCC CMRGlu in responders and non-responders were compared at baseline. Then machine learning analysis was performed with a leave-one-out cross-validation using a Gaussian naive Bayes classifier to test whether baseline CMRGlu in SCC could categorize responders. Finally, we compared 6-month change in metabolic activity with change in depression severity. All analyses were controlled for age. Baseline SCC CMRGlu was significantly higher in responders than non-responders. The machine learning analysis predicted response with 80% accuracy. Furthermore, reduction in SCC CMRGlu 6 months post DBS correlated with symptom improvement (r(17) = 0.509; p = 0.031). This is the first evidence of an image-based treatment selection biomarker that predicts SCC DBS response. Future studies could utilize SCC metabolic activity for prospective patient selection.",2020,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,['20 TRD patients'],['Subcallosal cingulate (SCC) deep brain stimulation (DBS'],"['Brain glucose metabolism (CMRGlu', 'Baseline SCC CMRGlu', 'SCC metabolic activity', 'response rates', 'metabolic activity', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0983597,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,"[{'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Molnar', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada. rramasub@ucalgary.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0745-5']
1222,32451203,Determination of the Effectiveness of Informing With the Guidance of an Education Booklet in Patients Undergoing Colonoscopy-A Randomized Controlled Trial.,"PURPOSE


The aim of this study was to determine the effect of precolonoscopy information with the guidance of an education booklet on anxiety and bowel preparation adequacy in patients undergoing colonoscopy.
DESIGN


A randomized controlled study.
METHODS


The education group was informed face to face by the researcher with the guidance of the colonoscopy education booklet and provided the education booklet. The control group received usual care.
FINDINGS


The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group. In the education group, the bowel preparation adequacy was determined to be higher compared with the control group.
CONCLUSIONS


Informing patients with the guidance of the education booklet before the colonoscopy decreased patients' state and trait anxiety levels and increased their bowel preparation adequacy.",2020,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"['Patients Undergoing Colonoscopy', 'patients undergoing colonoscopy']","['precolonoscopy', 'usual care', 'education booklet', 'Education Booklet', 'colonoscopy education booklet and provided the education booklet']","['bowel preparation adequacy', 'anxiety and bowel preparation adequacy', 'mean state and trait anxiety scores', ""patients' state and trait anxiety levels""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",,0.0400547,The mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group.,"[{'ForeName': 'Zeynep Kızılcık', 'Initials': 'ZK', 'LastName': 'Özkan', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey. Electronic address: zeynepkizilcik26@hotmail.com.'}, {'ForeName': 'Ümmü Yıldız', 'Initials': 'ÜY', 'LastName': 'Fındık', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Sciences, Trakya University, Edirne, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.12.009']
1223,32454087,Conventional versus daylight photodynamic therapy for acne vulgaris: A randomized and prospective clinical study in China.,"BACKGROUND


Photodynamic therapy (PDT) is an effective and safe treatment modality for acne vulgaris, and a variety of light sources have been investigated. Sunlight has been used as a PDT light source in a limited number of acne studies . However, to date, a comparative study of conventional PDT (C-PDT) and daylight PDT (DL-PDT) on acne is still lacking.
OBJECTIVES


This study aims to assess the efficacy and safety of DL-PDT vs. C-PDT in the treatment of acne vulgaris.
METHODS


Eighty patients with facial moderate-to-severe acne vulgaris were randomly assigned to either DL-PDT group or C-PDT group. All patients got two to three treatment sessions at two-week intervals. The lesions were photographed with VISIA digital imaging system at baseline and weeks 2, 4, and 6. Follow-up monthly for 3 months. The endpoints include efficacy (lesion response), safety (VAS pain score) and patient satisfaction.
RESULTS


A total of 77 patients completed the study. There was no statistical difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0 %, 90.0 %, and 94.7 % vs. 45.0 %, 85.0 %, and 92.3 %, p > 0.05). The IGA score of DL-PDT group has no difference from C-PDT at baseline and at weeks 6, respectively (3.3 ± 0.4, 1.5 ± 0.7 vs. 3.4 ± 0.5, 1.6 ± 0.7, p > 0.05). The VAS pain score of DL-PDT group was lower than that of C-PDT group (1.8 ± 0.2, vs. 5.8 ± 0.3, p < 0.05). Adverse reactions such as mild burning sensation, erythema, dryness, crusting, scales and hyperpigmentation were all tolerated. Patient satisfaction was similar between the two groups (p > 0.05).
CONCLUSIONS


DL-PDT is an effective and well-tolerated regimen for moderate-to-severe acne vulgaris compared with C-PDT.",2020,"There was no statistics difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0%, 90.0%, and 94.7% vs. 45.0%, 85.0%, and 92.3%, p > 0.05).","['Eighty patients with facial moderate-to-severe acne vulgaris', '77 patients completed the study', 'acne vulgaris']","['DL-PDT vs. C-PDT', 'Photodynamic therapy (PDT', 'Conventional versus daylight photodynamic therapy', 'DL-PDT group or C-PDT group', 'conventional PDT (C-PDT) and daylight PDT (DL-PDT']","['Patient satisfaction', 'VAS pain score', 'mild burning sensation, erythema, dryness, crusting, scales and hyperpigmentation were all tolerated', 'efficacy (lesion response), safety (VAS pain score) and patient satisfaction', 'efficacy and safety', 'objective response rate']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",80.0,0.0492389,"There was no statistics difference in objective response rate between DL-PDT group and C-PDT group at weeks 2, 4, and 6, respectively (40.0%, 90.0%, and 94.7% vs. 45.0%, 85.0%, and 92.3%, p > 0.05).","[{'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guolong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: zglamu@163.com.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: wangxiuli_1400023@tongji.edu.cn.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101796']
1224,32445440,Remdesivir for the Treatment of Covid-19 - Final Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).
CONCLUSIONS


Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1225,32445461,Cryoprecipitate Utilization Patterns Observed With a Required Prospective Approval Process vs Electronic Dosing Guidance.,"OBJECTIVES


We evaluated the impact of electronic medical record (EMR)-guided pooled cryoprecipitate dosing vs our previous practice of requiring transfusion medicine (TM) resident approval for every cryoprecipitate transfusion.
METHODS


At our hospital, cryoprecipitate pooled from five donors is dosed for adult patients, while single-donor cryoprecipitate is dosed for pediatric patients (defined as patients <50 kg in weight). EMR-based dosing guidance replaced a previously required TM consultation when cryoprecipitate pools were ordered, but a consultation remained required for single-unit orders. Usage was defined as thawed cryoprecipitate; wastage was defined as cryoprecipitate that expired prior to transfusion.
RESULTS


In the 6 months prior to intervention, 178 ± 13 doses of pooled cryoprecipitate were used per month vs 187 ± 15 doses after the intervention (P = .68). Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038). There was no change in wastage of pediatric cryoprecipitate doses during the study period. These trends remained unchanged for a full year postimplementation.
CONCLUSIONS


Electronic dosing guidance resulted in similar cryoprecipitate usage as TM auditing. Increased wastage may result from reduced TM oversight. Product wastage should be balanced against the possibility that real-time audits could delay a lifesaving therapy.",2020,Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038).,[],[],"['Wastage of pooled cryoprecipitate', 'wastage of pediatric cryoprecipitate doses']",[],[],"[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",,0.035965,Wastage of pooled cryoprecipitate increased from 7.7% ± 1.5% to 12.7% ± 1.4% (P = .038).,"[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neally', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Parvez M', 'Initials': 'PM', 'LastName': 'Lokhandwala', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ness', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Frank', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Gehrie', 'Affiliation': 'Division of Transfusion Medicine, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",American journal of clinical pathology,['10.1093/ajcp/aqaa042']
1226,32456097,Effects of a Rehabilitation Programme with a Nasal Inspiratory Restriction Device on Exercise Capacity and Quality of Life in COPD.,"OBJECTIVE


The objective was to assess the effects of a nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP) on exercise capacity, quality of life, dyspnea and inspiratory muscle strength in patients with stable COPD.
METHODS


Patients were randomized into three groups, one performed a supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). We evaluated inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT) before and after 8-week of RP.
RESULTS


A total of 16 patients completed the study, seven in FB group, five in ONB group and four in the CG. After the RP, the FB group showed a significant increase in P Imax  (93.3 ± 19.1 vs. 123.0 ± 15.8 mmHg) and in the 6MWT distance (462.9 ± 71.8m vs. 529.1 ± 50.1 m) and a decrease in the CAT score (9.7 ± 6.5 vs. 5.9 ± 6.0) and in the mMRC dyspnea score. FB provides greater improvement in P Imax , dyspnea, quality of life and 6MWT than ONB.
CONCLUSIONS


The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.",2020,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","['16 patients completed the study, seven in FB group, five in ONB group and four in the CG', 'patients with stable COPD', 'Patients']","['nasal restriction device for inspiratory muscle training, called Feelbreathe ® , added to a rehabilitation program (RP', 'Rehabilitation Programme with a Nasal Inspiratory Restriction Device', 'supervised RP using the Feelbreathe ®  device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG']","['CAT score', 'P Imax , dyspnea, quality of life and 6MWT', 'quality of life, dyspnea, exercise capacity and inspiratory muscle strength', 'Exercise Capacity and Quality of Life in COPD', 'mMRC dyspnea score', 'exercise capacity, quality of life, dyspnea and inspiratory muscle strength', 'P Imax', 'inspiratory muscle strength (P Imax ), dyspnea (mMRC), quality of life (CAT) and exercise capacity (6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",16.0,0.0239412,"The Feelbreathe ®  device provides greater improvements in quality of life, dyspnea, exercise capacity and inspiratory muscle strength compared to patients that did not use it.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'España-Domínguez', 'Affiliation': 'Pneumology, Allergy and Thoracic Surgery Department, University Hospital Puerta del Mar, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, Puerta del Mar University Hospital University of Cádiz, 11009 Cádiz, Spain.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Cuenca-García', 'Affiliation': 'GALENO Research Group, Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11003 Puerto Real, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103669']
1227,32460790,Higher doses of a green tea-based supplement increase post-exercise blood flow following an acute resistance exercise bout in recreationally resistance-trained college-aged men.,"BACKGROUND


There are animal data suggesting green tea can enhance blood flow. However, human data are lacking. Thus, the purpose of this study was to examine the acute effects of low and high doses of a green tea-based supplement (GBS) on brachial artery blood flow before and following a resistance exercise bout.
METHODS


In this, double-blinded placebo-controlled trial, college-aged males (n = 18) who self-reported recreationally resistance training for the previous 6 ± 3 years were assigned to one of two studies including a low (300 mg serving) (n = 9) or high dose (600 mg serving) (n = 8; 1 drop) GBS study. During testing sessions, participants reported to the laboratory following an overnight fast and rested in a supine position for 15 min. Thereafter, baseline measurements for resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF) were obtained (PRE). Participants then consumed either their respective GBS dose or a similar placebo dose (microcrystalline cellulose) in a supine resting state. HR, SBP, DBP, BAD and BBF were measured 45 min after placebo or GBS ingestion (PRE2). Participants were then placed in a recumbent position and performed 4 sets of 10 arm curl repetitions using an 11 kg dumbbell. Participants returned to a supine position and HR, SBP, DBP, BAD and BBF were obtained within the first 3 min following exercise (POST), 15 min after exercise (15POST), and 45 min after exercise (45POST). Participants returned to the laboratory 24-48 h later to repeat the same protocol with either GBS or the placebo depending on randomization. Two-way (supplement x time) repeated measures ANOVAs were used to compare dependent variables between testing sessions for Study 1 (300 mg of GBS and placebo) and Study 2 (600 mg of GBS and placebo), and statistical significance was set at p < 0.05. No statistical comparisons were made between studies.
RESULTS


As expected, exercise increased BAD and BBF compared to resting baseline measured irrespective of supplementation. In addition, BAD and BBF did not differ between GBS and placebo at any time point after exercise in Study 1. In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
CONCLUSIONS


These data suggest a higher dose of GBS can enhance localized blood flow acutely following a resistance exercise bout. However, the long-term implications of these data are unclear, and more well-powered studies are needed to validate efficacy and elucidate potential mechanisms.",2020,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
","['college-aged males (n\u2009=\u200918) who self-reported recreationally resistance training for the previous 6\u2009±\u20093\u2009years', 'recreationally resistance-trained college-aged men']","['GBS and placebo', 'placebo dose (microcrystalline cellulose', 'green tea-based supplement (GBS', 'GBS', 'placebo (placebo', 'green tea-based supplement increase post-exercise blood flow', 'placebo']","['brachial artery blood flow', 'BAD and BBF', 'supine position and HR, SBP, DBP, BAD and BBF', 'baseline-normalized BBF', 'resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF', 'HR, SBP, DBP, BAD and BBF', 'blood flow']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",,0.322958,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD.
","[{'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Fox', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Garner', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Petey W', 'Initials': 'PW', 'LastName': 'Mumford', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, Saint Charles, MO, USA.'}, {'ForeName': 'Darren T', 'Initials': 'DT', 'LastName': 'Beck', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roberts', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA. mdr0024@auburn.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00358-5']
1228,32460793,Influence of daily beer or ethanol consumption on physical fitness in response to a high-intensity interval training program. The BEER-HIIT study.,"BACKGROUND


High-intensity interval training (HIIT) is an effective approach to improve physical fitness, but consuming beer, which is a regular practice in many physically active individuals, may interfere with these effects. The purposes of this study were to investigate the effects of a 10-week (2 days/week) HIIT program on cardiorespiratory fitness, muscle strength and power parameters, and also to assess the possible influence on them of a moderate consumption of beer (at least from Monday to Friday) or its alcohol equivalent.
METHODS


Young (24 ± 6 years old) healthy adults (n = 73, 35 females) were allocated to five groups. Four groups participated in the HIIT intervention program while the fifth group was a control Non-Training group (n = 15). Participants in the training groups chose whether they preferred receiving alcohol or alcohol-free beverages. Those choosing alcohol were randomized to either beer or ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n = 13) or (ii) T-Ethanol (sparkling water with vodka, 5.4%; n = 14). Those choosing alcohol-free intake were randomized to (iii) T-Water group (sparkling water, 0.0%; n = 16), or (iv) T-0.0Beer group (alcohol-free beer, 0.0%; n = 15). Men ingested 330 ml of the beverage at lunch and 330 ml at dinner; women ingested 330 ml at dinner. Before and after the intervention, maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps were measured.
RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength. These positive effects were not influenced by the regular intake of beer or alcohol. No changes in the vertical jumps occurred in any of the groups.
CONCLUSIONS


A moderate beer or alcohol intake does not mitigate the positive effect of a 10-week HIIT on physical fitness in young healthy adults.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT03660579. Registered 20 September 2018. Retrospectively registered.",2020,"RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","['young healthy adults', 'Young (24\u2009±\u20096\u2009years old) healthy adults (n\u2009=\u200973, 35 females']","['beverage at lunch and 330\u2009ml at dinner; women ingested 330\u2009ml at dinner', 'HIIT intervention program', 'control Non-Training group', 'High-intensity interval training (HIIT', 'HIIT program', 'ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n\u2009=\u200913) or (ii) T-Ethanol', 'ethanol consumption', 'alcohol or alcohol-free beverages']","['absolute and relative values of VO 2 max, and total test duration', 'vertical jumps', 'physical fitness', 'maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps', 'cardiorespiratory fitness, muscle strength and power parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429930', 'cui_str': 'Test duration'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0166359,"RESULTS


HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Molina-Hidalgo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. criismh@correo.ugr.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dote-Montero', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. amarof@ugr.es.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00356-7']
1229,32467417,"A nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury: A randomised, placebo-controlled pilot study.","BACKGROUND


Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α.
OBJECTIVE


The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy.
DESIGN


Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study.
SETTING


Eight secondary care centres, the United Kingdom between April 2015 and June 2017.
PATIENTS


Thirty-three patients undergoing elective transthoracic oesophagectomy.
INTERVENTIONS


Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study.
MAIN OUTCOME MEASUREMENTS


Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models.
RESULTS


The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (-0.23, 0.39) in the placebo and 0.00 (-0.24, 0.37) in the GSK2862277 treatment groups. There were no significant treatment-related differences in PaO2/FiO2 or Sequential Organ Failure Assessment score. Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05). The frequency of adverse events and serious adverse events were distributed evenly across the two treatment arms.
CONCLUSION


Pre-operative treatment with a single 26 mg inhaled dose of GSK2862277 did not result in significantly lower postoperative alveolar capillary leak or extra vascular lung water. Unexpectedly small increases in transpulmonary thermodilution-measured PVPI and extra vascular lung water index at completion of surgery suggest less postoperative lung injury than historically reported, which may have also compromised a clear assessment of efficacy in this trial. GSK2862277 was well tolerated, resulted in expected lung exposure and reduced biomarkers of lung permeability and inflammation.
TRIAL REGISTRATION


clinicaltrials.gov: NCT02221037.",2020,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","['patients undergoing oesophagectomy', 'patients at risk of postoperative lung injury', 'Thirty-three patients undergoing elective transthoracic oesophagectomy', 'Eight secondary care centres, the United Kingdom between April 2015 and June 2017']","['GSK2862277', 'nebulised TNFR1 antagonist (GSK2862277', 'nebulised antitumour necrosis factor receptor-1 domain antibody', 'placebo']","['Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints', 'PaO2/FiO2 or Sequential Organ Failure Assessment score', 'postoperative alveolar capillary leak or extra vascular lung water', 'Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein', 'lung exposure and reduced biomarkers of lung permeability and inflammation', 'frequency of adverse events and serious adverse events', 'pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4279387', 'cui_str': 'GSK2862277'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1382398', 'cui_str': 'Increased capillary permeability'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0128546', 'cui_str': 'Small Inducible Cytokine A3'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162337', 'cui_str': 'Blood vessel permeability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0039807', 'cui_str': 'Thermodilution'}]",33.0,0.589958,"Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough (JR), GlaxoSmithKline Research and Development, Stevenage (AIB, TJW, EM,WP, RW, AF), Centre for Experimental Medicine, Queen's University of Belfast (DFM), Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (DFM), Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry (JY, GDP), Birmingham Acute Care Research Group, Institute of Inflammation and Aging, School of Clinical and Experimental Medicine, University of Birmingham (DRT, PAH), University Hospitals Birmingham, NHS Foundation Trust, Birmingham (JY, DRT, PAH, GDP), Department of Anaesthesia, Royal Victoria Hospital, Belfast (COD, MOS), Department of Medicine, University of Cambridge, Cambridge (AMV, CS), GlaxoSmithKline R&D, Stockley Park (KH), Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK (CS) and GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, USA (ALL).""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Bayliffe', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Howells', 'Affiliation': ''}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'Arlette M', 'Initials': 'AM', 'LastName': 'Vassallo', 'Affiliation': ''}, {'ForeName': 'Tracey J', 'Initials': 'TJ', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McKie', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hardes', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'Martin O', 'Initials': 'MO', 'LastName': 'Shields', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Powley', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001245']
1230,32468646,"Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease.","OBJECTIVE


Preclinical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, indicates improvement in Alzheimer's disease phenotypes. We investigated whether nilotinib is safe, and detectable in cerebrospinal fluid, and alters biomarkers and clinical decline in Alzheimer's disease.
METHODS


This single-center, phase 2, randomized, double-blind, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers in participants with mild to moderate dementia due to Alzheimer's disease. The diagnosis was supported by cerebrospinal fluid or amyloid positron emission tomography biomarkers. Nilotinib 150 mg versus matching placebo was taken orally once daily for 26 weeks followed by nilotinib 300 mg versus placebo for another 26 weeks.
RESULTS


Of the 37 individuals enrolled, 27 were women and the mean (SD) age was 70.7 (6.48) years. Nilotinib was well-tolerated, although more adverse events, particularly mood swings, were noted with the 300 mg dose. In the nilotinib group, central nervous system (CNS) amyloid burden was significantly reduced in the frontal lobe compared to the placebo group. Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo. Hippocampal volume loss was attenuated (-27%) at 12 months and phospho-tau-181 was reduced at 6 months and 12 months in the nilotinib group.
INTERPRETATION


Nilotinib is safe and achieves pharmacologically relevant cerebrospinal fluid concentrations. Biomarkers of disease were altered in response to nilotinib treatment. These data support a larger, longer, multicenter study to determine the safety and efficacy of nilotinib in Alzheimer's disease. ANN NEUROL 2020 ANN NEUROL 2020;88:183-194.",2020,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[""participants with mild to moderate dementia due to Alzheimer's disease"", ' 27 were women and the mean (SD) age was 70.7 (6.48) years', '37 individuals enrolled', ""Alzheimer's disease""]","['Nilotinib 150 mg versus matching placebo', 'nilotinib 300 mg versus placebo', 'placebo']","['safety, tolerability, and pharmacokinetics of nilotinib, and measured biomarkers', ""Safety, Tolerability, and Biomarkers in Alzheimer's Disease"", 'Hippocampal volume loss', 'central nervous system (CNS) amyloid burden', 'Cerebrospinal fluid Aβ40', 'safety and efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",27.0,0.589561,Cerebrospinal fluid Aβ40 was reduced at 6 months and Aβ42 was reduced at 12 months in the nilotinib group compared to the placebo.,"[{'ForeName': 'Raymond S', 'Initials': 'RS', 'LastName': 'Turner', 'Affiliation': 'Memory Disorders Program, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Lawler', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Mundel', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yusuf', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'J Nathan', 'Initials': 'JN', 'LastName': 'Starr', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Anjum', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Wangke', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Nuclear Medicine, Washington, DC, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Radiology, MedStar Georgetown Hospital, Washington, DC, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Neuroscience, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC, USA.'}]",Annals of neurology,['10.1002/ana.25775']
1231,32464142,"Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial.","BACKGROUND AND AIMS


Endoscopic assessment of mucosal appearance by independent central reading has become the standard method to assess Crohn's disease activity in clinical trials. The performance characteristics of various endoscopy reading models have yet to be systematically evaluated.
METHODS


This substudy included patients with Crohn's disease in the exploratory induction cohort of the BERGAMOT trial (NCT02394028) randomly assigned to etrolizumab or placebo. Endoscopies conducted at baseline and week 14 were independently scored using the Simple Endoscopic Score for Crohn's Disease (SES-CD) by a local reader (LR) and 2 central readers (CRs). Five endoscopy reading models were compared: single LR, single CR, average of 2 CRs, and 2 models incorporating the LR and 1 or 2 CRs depending on alignment between the LR and the CR, defined according to a sliding scale applied to a range of scores.
RESULTS


Five hundred thirty-five videos were scored. Models involving 2 readers demonstrated lower placebo rates (3.4%) than the single LR (11.9%) and the single CR (6.8%) models. Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 or 2 CRs (Δ = 16.2%). Further, in the etrolizumab arm, models with 2 readers demonstrated the lowest variability for the SES-CD.
CONCLUSIONS


Central endoscopy reading models in Crohn's disease have an impact on placebo response rates and effect size. Incorporating the LR appears to be important because models using both CRs and LRs resulted in the greatest treatment effect size for endoscopic improvement with etrolizumab, lower placebo rates, and reduced variability.",2020,Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 to 2 CRs (Δ = 16.2%).,"['Five hundred thirty-five videos were scored', ""Crohn's disease"", 'patients with CD in the exploratory induction cohort of BERGAMOT (NCT02394028) randomly assigned to']","['etrolizumab or placebo', 'various central endoscopy reading models']","['placebo rates', 'endoscopic improvement']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",535.0,0.293146,Treatment effect size based on endoscopic improvement (≥50% reduction in SES-CD from baseline) was highest with the 2 models incorporating the LR and 1 to 2 CRs (Δ = 16.2%).,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Mishkin', 'Affiliation': 'Atrius Health, Boston, Massachusetts.'}, {'ForeName': 'Young S', 'Initials': 'YS', 'LastName': 'Oh', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Fez', 'Initials': 'F', 'LastName': 'Hussain', 'Affiliation': 'Gastroenterology Center of Excellence, IQVIA, Reading.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Jacob', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'Atrius Health, Boston, Massachusetts.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daperno', 'Affiliation': 'Mauriziano Hospital, Turin, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.020']
1232,32472012,The effectiveness of quick starting oral contraception containing nomegestrol acetate and 17-β estradiol on ovulation inhibition: A randomized controlled trial.,"To determine the effectiveness of quick starting combined oral contraception (COC) contain 2.5 mg nomegestrol acetate and 1.5 mg estradiol (NOMAC/E2) comparing with 0.075 mg gestodene and 0.02 mg ethinyl estradiol (GS/EE) on ovarian ovulation inhibition rate, we conducted a non-inferiority randomized controlled trial involving 69 healthy female volunteers aged 18-40 years who had normal menstrual history and were randomized at a 2:1 ratio to take one pack of COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9. The ovarian activity was assessed by using Hoogland and Skouby grading. Forty-six and 23 participants were randomized to NOMAC/E2 and GS/EE groups, respectively. Baseline characteristics were similar between groups. No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000). Quick starting COC during day7-9 of menstrual cycle can inhibit ovulation for more than 90%. The quick starting NOMAC/E2 is non-inferior to GS/EE for preventing ovulation and suppressing follicular growth.",2020,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","['69 healthy female volunteers aged 18-40 years who had normal menstrual history', 'Forty-six and 23 participants']","['nomegestrol acetate and 17-β estradiol', 'NOMAC/E2 and GS/EE', 'gestodene and 0.02\u2009mg ethinyl estradiol (GS/EE', 'quick starting combined oral contraception (COC) contain 2.5\u2009mg nomegestrol acetate and 1.5\u2009mg estradiol (NOMAC/E2', 'COC containing either NOMAC/E2 (study group) or GS/EE (control group) starting on menstrual cycle Day7-9']","['ovarian ovulation inhibition rate', 'ovulation rate', 'ovarian quiescence rate', 'ovulation inhibition rate', 'persistent cyst rate', 'ovulation inhibition', 'ovarian activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0132749', 'cui_str': 'Nomegestrol acetate'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0061246', 'cui_str': 'Gestodene'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C0029968', 'cui_str': 'Ovulation Suppression'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",69.0,0.249135,"No significant difference was observed between the study and control groups for ovulation inhibition rate (93.4% vs. 95.6%, risk difference: -2.2%, 95% CI: -13.1, 8.8), ovarian quiescence rate (91.2% vs. 91.2%, P = 1.000), persistent cyst rate (2.2% vs. 4.4%, P = 1.000), and ovulation rate (6.6% vs. 4.4%, P = 1.000).","[{'ForeName': 'Preeyaporn', 'Initials': 'P', 'LastName': 'Jirakittidul', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. preeyajira@hotmail.com.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Angsuwathana', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manee', 'Initials': 'M', 'LastName': 'Rattanachaiyanont', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thunyada', 'Initials': 'T', 'LastName': 'Thiampong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanon', 'Initials': 'C', 'LastName': 'Neungton', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaphorn', 'Initials': 'B', 'LastName': 'Chotrungrote', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Scientific reports,['10.1038/s41598-020-65642-5']
1233,32472048,Efficacy of conbercept combined with panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.,"This prospective clinical study was to compare the effect of panretinal photocoagulation (PRP) associated with intravitreal conbercept injections versus PRP alone in the treatment of proliferative diabetic retinopathy (PDR). For each of 15 patients included, one eye was randomly assigned to receive treatment with PRP, and the other eye received conbercept combined PRP. Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) were performed at baseline and at each monthly visit until 6 months. Fluorescein angiography (FA) was acquired at baseline, 3 months and 6 months. Between group and within group analysis was done by using generalized estimating equations (GEE). The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months. Within-group analysis indicated a significant decrease in NV leakage at month 3 and month 6 in both groups, and a significant increase in BCVA at 1 month in the combination group. In summary, the combination of intravitreal injection of conbercept and PRP can significantly reduce the NV of PDR patients and achieve better BCVA during the drug's lifespan compared with PRP alone.",2020,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","['proliferative diabetic retinopathy', '15 patients included, one eye', 'proliferative diabetic retinopathy (PDR']","['PRP', 'conbercept combined with panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Fluorescein angiography (FA', 'intravitreal conbercept injections versus PRP alone', 'Ophthalmic examinations, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA', 'conbercept combined PRP']","['NV leakage', 'better best-corrected visual acuity (BCVA', 'BCVA', 'neovascularization (NV) leakage area']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0268657,"The combination group had a significant decrease of neovascularization (NV) leakage area than the PRP group at month 3 and month 6 after treatment, and a better best-corrected visual acuity (BCVA) during the first three months.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Statistics, School of Economics, Shanghai University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China. yuweihongeye@foxmail.com.'}]",Scientific reports,['10.1038/s41598-020-65833-0']
1234,32472075,Two nights of recovery sleep restores hippocampal connectivity but not episodic memory after total sleep deprivation.,"Sleep deprivation significantly impairs a range of cognitive and brain function, particularly episodic memory and the underlying hippocampal function. However, it remains controversial whether one or two nights of recovery sleep following sleep deprivation fully restores brain and cognitive function. In this study, we used functional magnetic resonance imaging (fMRI) and examined the effects of two consecutive nights (20-hour time-in-bed) of recovery sleep on resting-state hippocampal connectivity and episodic memory deficits following one night of total sleep deprivation (TSD) in 39 healthy adults in a controlled in-laboratory protocol. TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity. Following TSD, two nights of recovery sleep restored hippocampal connectivity to baseline levels, but did not fully restore memory performance nor its associations with hippocampal connectivity. These findings suggest that more than two nights of recovery sleep are needed to fully restore memory function and hippocampal-memory associations after one night of total sleep loss.",2020,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.",['39 healthy adults in a controlled in-laboratory protocol'],"['two consecutive nights (20-hour time-in-bed) of recovery sleep', 'total sleep deprivation (TSD', 'TSD', 'functional magnetic resonance imaging (fMRI']","['hippocampal connectivity to multiple prefrontal and default mode network regions', 'Sleep deprivation', 'memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",39.0,0.0326211,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Fan Nils', 'Initials': 'FN', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Sihua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Junghoon J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular, Cellular, and Biomedical Sciences, CUNY School of Medicine, The City College of New York, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. hengyi@pennmedicine.upenn.edu.'}]",Scientific reports,['10.1038/s41598-020-65086-x']
1235,32466190,The Effect of Physical Activity and High Body Mass Index on Health-Related Quality of Life in Individuals with Metabolic Syndrome.,"The main objective of this study was to examine the relationship between the level of physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL) in individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study. A total of 6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers. Subjects were classified according to categories of body mass index (BMI). PA was measured with the validated Registre Gironí del Cor (REGICOR) questionnaire and subjects were classified according to their PA level (light, moderate, vigorous) and the HRQoL was measured with the validated short-form 36 (SF-36) questionnaire. By using the ANOVA model, we found a positive and statistically significant association between the level of PA and the HRQoL (aggregated physical and mental dimensions  p  < 0.001), but a negative association with higher BMI in aggregated physical dimensions  p  < 0.001. Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36. Therefore, it is essential to promote PA and body weight control from primary care consultations to improve HRQoL, paying special attention to the differences that sex incurs.",2020,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","['6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers', 'Individuals with Metabolic Syndrome', 'individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study']",['Physical Activity and High Body Mass Index'],"['level of PA and the HRQoL', 'physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6875.0,0.0214871,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Marcos-Delgado', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Fernández-Villa', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J LLuís', 'Initials': 'JL', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Molina', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Babio', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ignacio M', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vaquero-Luna', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pastor-Morel', 'Affiliation': 'Centro de Salud Cabo Huertas, 03540 Alicante, Spain.'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Galmes-Panades', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Rios', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Bernal-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorin', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Zenaida', 'Initials': 'Z', 'LastName': 'Vázquez-Ruiz', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sorto-Sánchez', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Palau-Galindo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Galilea-Zabalza', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Muñoz-Martínez', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martín', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103728']
1236,32466396,Does Post-Activation Performance Enhancement Occur During the Bench Press Exercise under Blood Flow Restriction?,"Background :  The aim of the present study was to evaluate the effects of post-activation performance enhancement (PAPE) during successive sets of the bench press (BP) exercise under blood flow restriction (BFR). Methods :  The study included 10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction. During the experimental sessions, the study participants performed 3 sets of 3 repetitions of the BP exercise at 70%1RM with a 5 min rest interval between sets. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions were examined using 2-way (condition × set) repeated measures ANOVA. Furthermore, t-test comparisons between conditions were made for the set 2-set 1, set 3-set 1, and set 3-set 2 delta values for all variables. Results :  The post hoc results for condition × set interaction in PP showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for the CONT ( p  = 0.01) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition occurred ( p  < 0.01). The post hoc results for condition × set interaction in PV showed a significant increase in set 2 compared to set 1 for BFR ( p  < 0.01) and CONT ( p  = 0.01) conditions, a significant increase in set 3 compared to set 1 for CONT ( p  = 0.03) condition, as well as a significant decrease in set 3 compared to set 1 for BFR condition ( p  < 0.01). The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions. Conclusion :  The PAPE effect was analyzed through changes in power output and bar velocity that occurred under both the CONT and BFR conditions. However, the effects of PAPE have different kinetics in successive sets for BFR and for CONT conditions.",2020,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,['10 strength-trained males (age = 29.8 ± 4.6 years; body mass = 94.3 ± 3.6 kg; BP 1-repetition maximum (1RM) = 168.5 ± 26.4 kg'],"['exercise protocols: under blood flow restriction (BFR) and control test protocol (CONT) without blood flow restriction', 'PAPE', 'post-activation performance enhancement (PAPE', 'BP exercise']","['peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the CONT and BFR conditions', 'PP', 'BFR condition', 'blood flow restriction (BFR', 'power output and bar velocity']","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",10.0,0.0189799,The t-test comparisons showed significant differences in PP ( p  < 0.01) and PV ( p  = 0.01) for set 3-set 2 delta values between BFR and CONT conditions.,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szkudlarek', 'Affiliation': 'Department of Physical Pharmacy, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, 40-055 Katowice, Poland.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lockie', 'Affiliation': 'Center for Sports Performance, Department of Kinesiology, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17113752']
1237,32466854,Preoperative Vitamin D Supplementation in Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy.,"BACKGROUND


Transient hypocalcemia due to parathyroid gland or vessel manipulation is a common complication following thyroidectomy. Considering the role of 25-hydroxyvitamin D (25(OH)D) in calcium hemostasis, this study aimed to evaluate the effect of preoperative vitamin D supplementation on hypocalcemia incidence in thyroidectomy patients.
METHODS


In this randomized clinical trial, 100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled. Patients were randomly allocated to either study or control groups using the sealed envelope method. Patients in the study group received vitamin D3 50,000-unit pearl weekly for 4 weeks prior to the operation. The control group received placebo. Total and ionized serum calcium levels were checked before surgery, the day after surgery, and 2 weeks postoperatively.
RESULTS


No significant difference was observed in terms of demographic data. During serial total calcium checks (5 episodes), total calcium levels changed significantly in patients who had received vitamin D supplements compared to the control group (P = 0.043). Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D) (P = 0.04). Also, the requirement for intravenous calcium administration in order to treat the hypocalcemia symptoms was significantly lower in the study in comparison to the control group (P = 0.03).
CONCLUSIONS


Vitamin D supplementation in patients with vitamin D deficiency might lead to a lower incidence of early-onset symptomatic hypocalcemia; hence, requiring less calcium supplementation for the management of hypocalcemia.",2020,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"['100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled', 'thyroidectomy patients', 'Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy', 'patients with vitamin D deficiency']","['vitamin D supplements', 'preoperative vitamin D supplementation', 'Vitamin D supplementation', '25-hydroxyvitamin D (25(OH)D', 'Preoperative Vitamin D Supplementation', 'vitamin D3', 'placebo']","['Total and ionized serum calcium levels', 'demographic data', 'Symptomatic hypocalcemia incidence', 'total calcium levels', 'hypocalcemia symptoms', 'hypocalcemia incidence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0588547,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramouz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Mahdie', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Cardiothoracic Surgery, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyedeh Shaghayegh', 'Initials': 'SS', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Ziaeddin', 'Initials': 'SZ', 'LastName': 'Rasihashemi', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: zia.hashemi@yahoo.com.'}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.04.036']
1238,32468892,Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis.,"Objective : SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA).  Methods : Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated.  Results : The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined.  Conclusion : In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).",2020,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","['patients with rheumatoid arthritis (RA', 'Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study', '1709 patients', 'rheumatoid arthritis']","['tumour necrosis factor inhibitors', 'ADAbs']","['American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs', 'efficacy and tolerability', 'incidence of ISRs/IRRs', 'likelihood of developing ISRs/IRRs', 'cumulative incidences of ADAbs', 'ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",1709.0,0.148957,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital , Leeds, UK.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Suh', 'Affiliation': 'Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Division of Rheumatology, Mount Sinai Hospital, University of Toronto , Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, Stanford University School of Medicine , Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vencovsky', 'Affiliation': 'Department of Rheumatology, Institute of Rheumatology , Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hong', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghil', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1732458']
1239,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES


The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS


Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS


Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS


Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Van Nuys Medical Science Building, Suite 224, 635 Barnhill Drive, Indianapolis, IN 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalopamaya@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
1240,32472001,Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis.,"The OlympiAD Phase III study (NCT02000622) established the clinical benefits of olaparib tablet monotherapy (300 mg twice daily) over chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting. Here, we report pre-specified analyses of data from Asian (China, Japan, Korea and Taiwan) patients in the study. All patients were randomized 2:1 to olaparib tablets (300 mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine). The primary endpoint was progression-free survival assessed by blinded independent central review. The prevalence of gBRCAm in the OlympiAD Asian subgroup screened for study recruitment was 13.5%. Patient demographics and disease characteristics of the Asian subgroup (87/302 patients) were generally well balanced between treatment arms. Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population. Findings on secondary efficacy and safety/tolerability outcome measures in Asian patients were also similar to those observed in the global OlympiAD study population. The OlympiAD study was not powered to detect race-related differences between treatment groups; however, the consistency of our findings with the global OlympiAD study population suggests that previously reported findings are generalizable to Asian patients.",2020,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","['Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer', 'patients with a germline BRCA1/2 mutation (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who had received ≤2 chemotherapy lines in the metastatic setting', 'Asian (China, Japan, Korea and Taiwan) patients in the study', 'Asian patients']","['olaparib tablet monotherapy', ""chemotherapy treatment of physician's choice (TPC"", 'olaparib tablets (300\u2009mg twice daily) or single-agent chemotherapy TPC (21-day cycles of either capecitabine, eribulin or vinorelbine', 'Olaparib monotherapy']","['secondary efficacy and safety/tolerability outcome measures', 'progression-free survival', 'longer median progression-free survival']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.177673,"Asian patients in the olaparib arm achieved longer median progression-free survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs 4.2 months; HR = 0.53 [95% CI: 0.29-0.97]), which was consistent with findings in the global OlympiAD study population.","[{'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea. moisa@snu.ac.kr.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Medical Oncology Center, Hunan Tumor Hospital, Changsha, China.'}, {'ForeName': 'Dah-Cherng', 'Initials': 'DC', 'LastName': 'Yeh', 'Affiliation': 'Cheng Ching Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyuk', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ling-Ming', 'Initials': 'LM', 'LastName': 'Tseng', 'Affiliation': 'Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-63033-4']
1241,32460138,Social timing influences sleep quality in patients with sleep disorders.,"OBJECTIVES


We aimed to compare three variants of the Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ) and to assess whether chronotype (MSF sc )/social jetlag (SJL) are associated with sleep quality in patients with sleep disorders (SD).
METHODS


In sum, 431 SD patients and 338 subjects from the general population (GP) were included. Participants filled in three variants of the PSQI and the Munich ChronoType Questionnaire (MCTQ). We used Generalized Estimating Equations (GEE) to investigate effects of group (GP, SD), PSQI (usual, work or free) and their interaction (group∗PSQI) on scores. To investigate associations between MSF sc /SJL and the difference between PSQI w  and PSQI f  (PSQI diff ) in patients with SD we used linear regressions (N = 352). We used Sobel to test whether there was a mediation effect of SJL on the association between MSF sc  and PSQI diff .
RESULTS


PSQI scores differed between groups (p < 0.001). Post-hoc analysis revealed a significant difference between PSQI u  vs. PSQI f  and PSQI w  vs. PSQI f  with PSQI f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group. In line with previous findings, SJL was associated to PSQI diff  in SD patients.
CONCLUSIONS


PSQI u  mainly represents sleep quality on workdays also in SD patients. Being a late chronotype seems to be associated with higher differences in sleep quality on work-vs. free days mostly when it coincides with societal time constraints. Since sleep quality is poorer on workdays even in SD patients, we suggest that treatment strategies should address social aspects affecting sleep, including ways of minimizing SJL.",2020,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","['patients with sleep disorders (SD', 'patients with SD', 'patients with sleep disorders', '431 SD patients and 338 subjects from the general population (GP) were included', 'SD patients']","['chronotype (MSF sc )/social jetlag (SJL', 'MSF sc /SJL', 'PSQI', 'SJL']","['PSQI (usual, work or free) and their interaction (group∗PSQI) on scores', 'PSQI u  vs. PSQI f  and PSQI w  vs. PSQI', 'Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ', 'PSQI scores', 'Munich ChronoType Questionnaire (MCTQ', 'sleep quality', 'PSQI w  and PSQI f  (PSQI diff ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0284205,"f  presenting lower scores, while PSQI u  vs. PSQI w  did not differ in any group.","[{'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Reis', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; IMM - Faculty of Medicine João Lobo Antunes, University of Lisbon, Portugal.'}, {'ForeName': 'Luísa K', 'Initials': 'LK', 'LastName': 'Pilz', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Laboratório de Cronobiologia e Sono, HCPA/UFRGS, Porto Alegre, RS, Brazil; PPG em Psiquiatria e Ciências do Comportamento, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lena Katharina', 'Initials': 'LK', 'LastName': 'Keller', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Department of Child and Adolescent Psychiatry, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paiva', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; CHRC - Nova Medical School - Faculdade de Ciências Médicas, Lisbon, Portugal.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Roenneberg', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany. Electronic address: roenneberg@lmu.de.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.019']
1242,32460801,The addition of β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation does not improve anthropometric and performance maintenance across a collegiate rugby season.,"BACKGROUND


Muscular damage sustained while playing rugby may hinder performance across a season. β-Hydroxy β-Methylbutyrate (HMB) may help attenuate muscle damage and maintain lean mass and performance. This study sought to determine the effect of combining HMB with creatine monohydrate supplementation on measures of stress and muscle damage, body composition, strength and sprinting kinetics throughout a rugby season.
METHODS


This double-blind, cross-over investigation recruited 16 male collegiate rugby players to provide resting blood samples and complete assessments of body composition, strength and sprinting performance prior to their fall season (PRE FALL ). After testing, the athletes were matched for fat-free mass and assigned to consume one of two supplementation regimens for 6 weeks: 5 g HMB + 5 g creatine per day (HMB-Cr: 20.9 ± 1.1 years; 177 ± 2 cm; 88.4 ± 4.9 kg) or 5 g creatine + 5 g placebo per day (Cr: 21.4 ± 2.1 years; 179 ± 2 cm; 88.3 ± 4.9 kg). After 6 weeks (POST FALL ), PRE FALL  testing was repeated in 13 of the original 16 athletes before a 10-wk wash-out period. Athletes who returned for the spring season (n = 8) repeated all fall-season procedures and testing prior to (PRE SPRING ) and following (POST SPRING ) their 6-wk spring season, except they were assigned to the opposite supplementation regimen.
RESULTS


Linear mixed models with repeated measures revealed group x time interactions (p <  0.05) for observed for several measures but did not consistently and positively favor one group. During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring. In the spring, greater knee flexor rate of torque development (~ 149 Nm·sec - 1 , p = 0.003) and impulse (~ 4.5 Nm·sec, p = 0.022) were observed in Cr at PRE SPRING  but not at POST SPRING . Although significant interactions were found for cortisol concentrations, vastus lateralis pennation angle, and sprinting force, post-hoc analysis only revealed differences between fall and spring seasons. No other differences were observed.
CONCLUSIONS


The combination of HMB and creatine monohydrate supplementation does not provide a greater ergogenic benefit compared to creatine monohydrate supplementation alone. Body composition, strength, and sprinting ability did not change across the season with creatine monohydrate supplementation.",2020,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.",['16 male collegiate rugby players'],"['β-Hydroxy β-Methylbutyrate (HMB', 'β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation', 'HMB and creatine monohydrate supplementation', 'HMB\u2009+\u20095\u2009g creatine per day (HMB-Cr: 20.9\u2009±\u20091.1\u2009years; 177\u2009±\u20092\u2009cm; 88.4\u2009±\u20094.9\u2009kg) or 5\u2009g creatine +\u20095\u2009g placebo', 'HMB with creatine monohydrate supplementation']","['measures of stress and muscle damage, body composition, strength and sprinting kinetics', 'knee extensor peak torque', 'body composition, strength and sprinting performance prior to their fall season (PRE FALL ', 'Body composition, strength, and sprinting ability', 'knee flexor rate of torque development', 'cortisol concentrations, vastus lateralis pennation angle, and sprinting force']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",16.0,0.209374,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.","[{'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia. gmangine@kennesaw.edu.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Hester', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Julian', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Feito', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00359-4']
1243,32466147,The Effects of Multifaceted Ergonomic Interventions on Musculoskeletal Complaints in Intensive Care Units.,"Working at intensive care units (ICUs) is considered a risk factor for developing musculoskeletal complaints (MSC). This study was conducted between January 2017 and June 2019 in two ICUs of a university hospital. It was designed as a pre- and post-assessment of the intervention group (IG) (N = 27) compared with a control group (CG) (N = 23) to determine the effects of a multifaceted ergonomics intervention program in reducing MSC. The IG (N: 35) received a multifaceted ergonomic intervention program, which was implemented by an ERGO team over an 18 month period. Four ergonomic interventions were planned as follows: individual level interventions such as training; stretching exercises and motivation meetings; administrative intervention such as a daily 10 min stretching exercises break; engineering interventions such as lifting and usage of auxiliary devices. The CG (N:29) did not receive any intervention. Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) was used to assess MSC in both groups. At the start of the intervention, both groups were similar concerning the number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores ( p  > 0.05 for all). Two factor repeated ANOVA measures were performed for between-groups and within-group analyses. The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001). However, the interaction effect of group and time (between and within factors) was not significant ( p  = 0.992). Work-related MSC is a common occupational health problem among nurses. This study showed that individual-level interventions are not likely to succeed in eliminating manual patient lifting by nurses. Our results suggested that interventions without administrative measures might have limited success.",2020,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001).,"['Musculoskeletal Complaints in Intensive Care Units', 'January 2017 and June 2019 in two ICUs of a university hospital']","['multifaceted ergonomics intervention program', 'multifaceted ergonomic intervention program', 'Multifaceted Ergonomic Interventions']","['number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores', 'mean of the initial CMSDQ total scores', 'Cornell Musculoskeletal Discomfort Questionnaire (CMDQ']","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0244086,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p  < 0.001).,"[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Coskun Beyan', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Dilek', 'Affiliation': 'Physical Therapy and Rehabilitation Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Yucel', 'Initials': 'Y', 'LastName': 'Demiral', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}]",International journal of environmental research and public health,['10.3390/ijerph17103719']
1244,32469393,"Effects of a multinutrient-fortified milk drink combined with exercise on functional performance, muscle strength, body composition, inflammation, and oxidative stress in middle-aged women: a 4-month, double-blind, placebo-controlled, randomized trial.","BACKGROUND


Multinutrient protein-enriched supplements are promoted to augment the effects of exercise on muscle mass and strength, but their effectiveness in middle-aged women, or whether there are any additional benefits to physical function, remains uncertain.
OBJECTIVES


We aimed to evaluate whether a multinutrient-fortified milk drink (MFMD) could enhance the effects of exercise on functional muscle power (stair climbing) in middle-aged women. Secondary aims were to evaluate the intervention effects on physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids.
METHODS


In this 4-mo, double-blind, placebo-controlled, randomized trial, 244 women (45-65 y) participated in a multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex + MFMD, n = 123) or an energy-matched placebo (Ex + placebo, n = 121).
RESULTS


A total of 216 women (89%) completed the study. After 4 mo, both groups experienced similar 3.6%-4.3% improvements in the primary outcomes of fast-pace 5- and 10-step stair ascent power. In contrast, Ex + MFMD experienced greater improvements in 5-step regular-pace stair descent time [net difference (95% CI): -0.09 s (-0.18, 0.00 s), P = 0.045], countermovement jump height [0.5 cm (0.04, 1.0 cm), P = 0.038], total body LM [0.3 kg (0.04, 0.60 kg), P = 0.020], FM [-0.6 kg (-1.0, -0.2 kg), P = 0.004], BMC [0.4% (0.1%, 0.6%), P = 0.020], muscle CSA [thigh: 1.8% (0.6%, 2.9%), P = 0.003; lower leg: 0.9% (0.3%, 1.6%), P = 0.005], balance eyes closed [3.3 s (1.1, 5.4 s), P = 0.005], 2-min step performance [8 steps (3, 12 steps), P = 0.003], and sit-and-reach flexibility [1.4 cm (0.6, 2.2 cm), P = 0.026]. MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover. Ex + placebo had a greater improvement in the oxidative stress marker protein carbonyls (P < 0.01).
CONCLUSIONS


In middle-aged women, daily consumption of an MFMD did not enhance the effects of a multimodal exercise program on the primary outcome of stair climbing ascent power, but did elicit greater improvements in multiple secondary outcomes including various other measures of functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism.This trial was registered at www.anzctr.org.au as ACTRN12617000383369.",2020,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","['middle-aged women', '216 women (89%) completed the study', '244 women (45-65 y) participated in a']","['multinutrient-fortified milk drink combined with exercise', 'MFMD', 'multimodal exercise program', 'multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex\xa0+\xa0MFMD, n\xa0=\xa0123) or an energy-matched placebo (Ex\xa0+\xa0placebo, n\xa0=\xa0121', 'multinutrient-fortified milk drink (MFMD', 'Ex\xa0+\xa0placebo', 'placebo']","['physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids', 'functional performance, muscle strength, body composition, inflammation, and oxidative stress', 'countermovement jump height', 'sit-and-reach flexibility', 'BMC', 'oxidative stress marker protein carbonyls', 'blood pressure, markers of inflammation, or cartilage turnover', 'functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism', 'fast-pace 5- and 10-step stair ascent power', 'total body LM', 'muscle strength, gait speed, dynamic balance, reaction time, or blood lipids', 'functional muscle power (stair climbing', '5-step regular-pace stair descent time']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",244.0,0.577968,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'De Ross', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Kruger', 'Affiliation': 'School of Health Sciences, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schollum', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gunn', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa126']
1245,32475359,"Glucose control upon waking is unaffected by hourly sleep fragmentation during the night, but is impaired by morning caffeinated coffee.","Morning coffee is a common remedy following disrupted sleep, yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults. Remarkably, the combined effects of sleep fragmentation and coffee on glucose control upon waking per se have never been investigated. In a randomised crossover design, twenty-nine adults (mean age: 21 (sd 1) years, BMI: 24·4 (sd 3·3) kg/m2) underwent three oral glucose tolerance tests (OGTT). One following a habitual night of sleep (Control; in bed, lights-off trying to sleep approximately 23.00-07.00 hours), the others following a night of sleep fragmentation (as Control but waking hourly for 5 min), with and without morning coffee approximately 1 h after waking (approximately 300 mg caffeine as black coffee 30 min prior to OGTT). Individualised peak plasma glucose and insulin concentrations were unaffected by sleep quality but were higher following coffee consumption (mean (normalised CI) for Control, Fragmented and Fragmented + Coffee, respectively; glucose: 8·20 (normalised CI 7·93, 8·47) mmol/l v. 8·23 (normalised CI 7·96, 8·50) mmol/l v. 8·96 (normalised CI 8·70, 9·22) mmol/l; insulin: 265 (normalised CI 247, 283) pmol/l; and 235 (normalised CI 218, 253) pmol/l; and 310 (normalised CI 284, 337) pmol/l). Likewise, incremental AUC for plasma glucose was higher in the Fragmented + Coffee trial compared with Fragmented. Whilst sleep fragmentation did not alter glycaemic or insulinaemic responses to morning glucose ingestion, if a strong caffeinated coffee is consumed, then a reduction in glucose tolerance can be expected.",2020,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"['healthy adults', '29 adults (Mean ± SD; age: 21 ± 1 years, BMI: 24.4 ± 3.3 kg·m-2) underwent three']","['habitual night of sleep (Control; in bed, lights-off trying to sleep ~2300-0700 h) the others following a night of sleep fragmentation', 'oral glucose tolerance tests (OGTT', 'Fragmented+Coffee']","['glucose tolerance', 'Likewise, iAUC for plasma glucose']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",29.0,0.0411912,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"[{'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Perkin', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001865']
1246,32470531,The high-risk ECG pattern of ST-elevation myocardial infarction: A substudy of the randomized trial of primary PCI with or without routine manual thrombectomy (TOTAL trial).,"BACKGROUND


Useful tools for risk assessment in patients with STEMI are needed. We evaluated the prognostic impact of the evolving myocardial infarction (EMI) and the preinfarction syndrome (PIS) ECG patterns and determined their correlation with angiographic findings and treatment strategy.
METHODS


This substudy of the randomized Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern. The primary outcome was a composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year.
RESULTS


The primary outcome occurred in 271 of 2618 patients (10.4%) in the EMI group vs. 322 of 5242 patients (6.1%) in the PIS group [AdjustedHR, 1.54; 95% CI, 1.30 to 1.82; p < .001]. The primary outcome occurred in the thrombectomy and PCI alone groups in 131 of 1306 (10.0%) and 140 of 1312 (10.7%) patients with EMI [HR 0.94; 95% CI, 0.74-1.19] and 162 of 2633 (6.2%) and 160 of 2609 (6.1%) patients with PIS [HR 1.00; 95% CI, 0.81-1.25], respectively (p interaction  = 0.679).
CONCLUSIONS


Patients with the EMI ECG pattern proved to have an increased rate of the primary outcome within one year compared to the PIS pattern. Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns. The PIS/EMI dynamic ECG classification could help to triage patients in case of simultaneous STEMI patients with immediate need for pPCI.",2020,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"['ST-elevation myocardial infarction', 'patients with STEMI', 'Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern']","['PCI versus PCI Alone', 'primary PCI with or without routine manual thrombectomy']","['composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0086666', 'cui_str': 'Preinfarction syndrome'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",7860.0,0.0957483,Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns.,"[{'ForeName': 'Joonas', 'Initials': 'J', 'LastName': 'Leivo', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland. Electronic address: joonas.leivo@fimnet.fi.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Anttonen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.'}, {'ForeName': 'Jyri', 'Initials': 'J', 'LastName': 'Koivumäki', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Tahvanainen', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Koivula', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland; Internal medicine, Helsinki University Hospital, Finland.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Nikus', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; David Braley Cardiac, Vascular and Stroke Research Institute, Hamilton, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Niemelä', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Eskola', 'Affiliation': 'Heart Center, Department of Cardiology, Tampere University Hospital, Finland; Faculty of Medicine and Health Technology, Tampere University, Finnish Cardiovascular Research Center, Tampere, Finland.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.053']
1247,32477961,Significant Short-Term Shifts in the Microbiomes of Smokers With Periodontitis After Periodontal Therapy With Amoxicillin & Metronidazole as Revealed by 16S rDNA Amplicon Next Generation Sequencing.,"The aim of this follow-up study was, to compare the effects of mechanical periodontal therapy with or without adjunctive amoxicillin and metronidazole on the subgingival microbiome of smokers with periodontitis using 16S rDNA amplicon next generation sequencing. Fifty-four periodontitis patients that smoke received either non-surgical periodontal therapy with adjunctive amoxicillin and metronidazole (n = 27) or with placebos (n = 27). Subgingival plaque samples were taken before and two months after therapy. Bacterial genomic DNA was isolated and the V4 hypervariable region of the bacterial 16S rRNA genes was amplified. Up to 96 libraries were normalized and pooled for Illumina MiSeq paired-end sequencing with almost fully overlapping 250 base pairs reads. Exact ribosomal sequence variants (RSVs) were inferred with DADA2. Microbial diversity and changes on the genus and RSV level were analyzed with non-parametric tests and a negative binomial regression model, respectively. Before therapy, the demographic, clinical, and microbial parameters were not significantly different between the placebo and antibiotic groups. Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups. In the antibiotic group, there was a significant reduction of genera classified as  Porphyromonas, Tannerella , and  Treponema , and 22 other genera also decreased significantly, while  Selenomonas, Capnocytophaga, Actinomycetes , and five other genera significantly increased. In the placebo group, however, there was not a significant decrease in periodontal pathogens after therapy and only five other genera decreased, while  Veillonella  and nine other genera increased. We conclude that in periodontitis patients who smoke, microbial shifts occurred two months after periodontal therapy with either antibiotics or placebo, but genera including periodontal pathogens decreased significantly only with adjunctive antibiotics.",2020,"Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups.","['Fifty-four periodontitis patients that smoke received either', 'smokers with periodontitis using 16S rDNA amplicon next generation sequencing', 'Smokers With Periodontitis']","['placebos', 'non-surgical periodontal therapy with adjunctive amoxicillin and metronidazole', 'Amoxicillin & Metronidazole', 'mechanical periodontal therapy with or without adjunctive amoxicillin and metronidazole', 'placebo']","['genera classified as  Porphyromonas, Tannerella , and  Treponema', 'Microbial diversity and changes on the genus and RSV level', 'Subgingival plaque samples', 'dissimilarity of microbiomes', 'periodontal pathogens']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1217351', 'cui_str': 'Tannerella'}, {'cui': 'C0040837', 'cui_str': 'Treponema'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",250.0,0.0157877,"Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hagenfeld', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Matern', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Prior', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harks', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eickholz', 'Affiliation': 'Department of Periodontology, Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Department of Periodontology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ti-Sun', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': 'Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kocher', 'Affiliation': 'Unit of Periodontology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontology, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kaner', 'Affiliation': 'Department of Periodontology, Dental School, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Harmsen', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ehmke', 'Affiliation': 'Department of Periodontology and Operative Dentistry, Münster University Hospital, Münster, Germany.'}]",Frontiers in cellular and infection microbiology,['10.3389/fcimb.2020.00167']
1248,32476255,"Effects of dipeptidyl peptidase-4 inhibitor linagliptin versus sulphonylurea glimepiride on systemic haemodynamics in overweight patients with type 2 diabetes: A secondary analysis of an 8-week, randomized, controlled, double-blind trial.","AIM


To determine the glucose-independent effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin versus the sulphonylurea glimepiride on systemic haemodynamics in the fasting and postprandial state in patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


In this prespecified secondary analysis of a phase IV, double-blind trial, 46 metformin-treated, overweight patients with T2D were included and randomly assigned (1:1) to once-daily linagliptin (5 mg) or glimepiride (1 mg) for 8 weeks. In a sub-study involving 26 patients, systemic haemodynamics were also assessed following a standardized liquid meal (Nutridrink Yoghurt style). Systemic haemodynamics (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry) and cardiac sympathovagal balance (heart rate variability [HRV]) were measured in the fasting state and repetitively following the meal. Ewing tests were performed in the fasting state.
RESULTS


From baseline to week 8, linagliptin compared with glimepiride did not affect systemic haemodynamics, arterial stiffness or HRV in the fasting state. Linagliptin increased parasympathetic nervous activity, as measured by the Valsalva manoeuvre (P = .021) and deep breathing test (P = .027) compared with glimepiride. Postprandially, systolic blood pressure (SBP) dropped an average of 7.6 ± 1.6 mmHg. Linagliptin reduced this decrease to 0.7 ± 2.3 mmHg, which was significant to glimepiride (P = .010).
CONCLUSIONS


When compared with glimepiride, linagliptin does not affect fasting blood pressure. However, linagliptin blunted the postprandial drop in SBP, which could benefit patients with postprandial hypotension.",2020,"RESULTS


From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","['46 metformin-treated, overweight T2DM patients', 'overweight patient with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM']","['Linagliptin', 'glimepiride, linagliptin', 'sulfonylurea glimepiride', 'dipeptidyl peptidase (DPP)-4 inhibitor linagliptin', 'glimepiride', 'DPP-4 inhibitor linagliptin', 'linagliptin']","['systemic hemodynamics, arterial stiffness or HRV', 'systemic hemodynamics', 'fasting blood pressure', 'parasympathetic nervous activity', 'Systemic haemodynamic (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry), and cardiac sympathovagal balance (heart rate variability; HRV', 'Valsalva-manoeuvre', 'systemic haemodynamics']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}]",26.0,0.102531,"RESULTS


From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Kraaijenhof', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'German Diabetes Center (DDZ), Leibniz Center for Diabetes Research, Heinrich Heine University, Medical Faculty, Düsseldorf, Germany.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14107']
1249,32482626,Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.,"BACKGROUND


Older patients with cancer often find it difficult to take part in shared decision making.
AIM


To assess the utility of the Outcome Prioritisation Tool (OPT), designed to aid discussion with a patient in regards to their treatment goals, to empower patients with cancer through structured conversations about generic treatment goals with GPs.
DESIGN AND SETTING


A randomised controlled trial of 114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist. The intervention group used the OPT while the control group received care as usual.
METHOD


The primary outcome was patient empowerment using the score on the decision self-efficacy (DSE) scale. Secondary outcomes were symptoms measures of fatigue, anxiety, and depression. The experiences of participants were also explored.
RESULTS


No effect was found on patient empowerment between the OPT group ( n  = 48; DSE 86.8; standard deviation [SD] = 18.2) and the control group ( n  = 58; DSE 84.2; SD = 17.6;  P  = 0.47). In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05). Overall, 44.8% ( n  = 13) of patients indicated that the OPT-facilitated conversation helped them make a treatment decision, and 31.1% ( n  = 14) of the GPs reported that they gained new insights from the conversation.
CONCLUSION


An OPT-facilitated conversation about generic treatment goals between patients and their GPs is associated with less anxiety and fatigue, but did not show statistically significant improvements in patient empowerment. Adding the OPT to routine care might ensure more patient-tailored care.",2020,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05).","['Older patients with cancer', 'older patients with non-curable cancer', 'patients with cancer through structured conversations about generic treatment goals with GPs', '114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist']","['OPT while the control group received care as usual', 'Outcome Prioritisation Tool (OPT']","['symptoms measures of fatigue, anxiety, and depression', 'patient empowerment using the score on the decision self-efficacy (DSE) scale', 'mild fatigue', 'anxiety and fatigue', 'patient empowerment', 'mean anxiety scores', 'low empowerment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",114.0,0.0458868,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%,  n  = 9 versus 24.1%,  n  = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%,  n  = 30 versus 77.2%,  n  = 44;  P  = 0.05).","[{'ForeName': 'Mariken E', 'Initials': 'ME', 'LastName': 'Stegmann', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Brandenbarg', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'T Jeroen N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X710405']
1250,32483134,The atorvastatin metabolic phenotype shift is influenced by interaction of drug-transporter polymorphisms in Mexican population: results of a randomized trial.,"Atorvastatin (ATV) is a blood cholesterol-lowering drug used to prevent cardiovascular events, the leading cause of death worldwide. As pharmacokinetics, metabolism and response vary among individuals, we wanted to determine the most reliable metabolic ATV phenotypes and identify novel and preponderant genetic markers that affect ATV plasma levels. A controlled, randomized, crossover, single-blind, three-treatment, three-period, and six-sequence clinical study of ATV (single 80-mg oral dose) was conducted among 60 healthy Mexican men. ATV plasma levels were measured using high-performance liquid chromatography mass spectrometry. Genotyping was performed by real-time PCR with TaqMan probes. Four ATV metabolizer phenotypes were found: slow, intermediate, normal and fast. Six gene polymorphisms, SLCO1B1-rs4149056, ABCB1-rs1045642, CYP2D6-rs1135840, CYP2B6-rs3745274, NAT2-rs1208, and COMT- rs4680, had a significant effect on ATV pharmacokinetics (P < 0.05). The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer. This is the first study that demonstrates how the interaction of genetic variants affect metabolic phenotyping and improves understanding of how SLCO1B1 and ABCB1 variants that affect statin metabolism may partially explain the variability in drug response. Notwithstanding, the influence of other genetic and non-genetic factors is not ruled out.",2020,The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer.,"['60 healthy Mexican men', 'Mexican population']","['Atorvastatin (ATV', 'ATV']","['ATV plasma levels', 'ATV pharmacokinetics']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",60.0,0.0262018,The polymorphisms in SLCO1B1 and ABCB1 seemed to have a greater effect and were especially important for the shift from an intermediate to a normal metabolizer.,"[{'ForeName': 'Rafael B R', 'Initials': 'RBR', 'LastName': 'León-Cachón', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico. rafael.reyesleon@udem.edu.'}, {'ForeName': 'Aileen-Diane', 'Initials': 'AD', 'LastName': 'Bamford', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Meester', 'Affiliation': 'Center of Molecular Diagnostics and Personalized Medicine, Department of Basic Sciences, Division of Health Sciences, University of Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico.'}, {'ForeName': 'Hugo Alberto', 'Initials': 'HA', 'LastName': 'Barrera-Saldaña', 'Affiliation': 'Vitagenesis S.A., Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Gómez-Silva', 'Affiliation': 'Forensic Medicine Service, School of Medicine, Autonomous University of Nuevo Leon, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'María F García', 'Initials': 'MFG', 'LastName': 'Bustos', 'Affiliation': 'Institute of Experimental Pathology (CONICET), Faculty of Health Sciences, National University of Salta, Salta, Argentina.'}]",Scientific reports,['10.1038/s41598-020-65843-y']
1251,32483139,The Haemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: A Randomised Controlled Trial.,"Endotracheal intubation elicits huge spectrum of stress responses which are hazardous in high-risk patients. Numerous drugs and techniques have been applied to attenuate the stress responses. In this double-blind study, one hundred and forty-five patients over 20 years old, ASA physical status I and II, undergoing elective surgeries requiring general anaesthesia with endotracheal intubation were included. Patients were randomly divided into three groups which fentanyl 2 mcg/kg was given at either 1, 2, 3 minutes before intubation. All groups received midazolam 0.05 mg/kg, lidocaine 0.5 mg/kg, propofol 2 mg/kg and rocuronium 1 mg/kg before intubation. Haemodynamic parameters were recorded for 10 minutes after induction. Two-level longitudinal hierarchical linear models were used for data interpretation and P < 0.05 was considered statistically significant. The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05). Confounding factors such as smoking, hypertension, diabetes mellitus and preoperative intravenous fluid supplement were analysed. In conclusion, fentanyl injection 2 minutes before intubation is recommended in order to obtain the most stable haemodynamic status.",2020,The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05).,"['one hundred and forty-five patients over 20 years old, ASA physical status I and II, undergoing elective surgeries requiring general anaesthesia with endotracheal intubation were included', 'high-risk patients']","['Fentanyl', 'midazolam 0.05\u2009mg/kg, lidocaine 0.5\u2009mg/kg, propofol 2\u2009mg/kg and rocuronium 1\u2009mg/kg before intubation', 'Endotracheal intubation']","['haemodynamic responses', 'Haemodynamic parameters']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",145.0,0.0873971,The study demonstrated significantly lower haemodynamic responses in the group who received fentanyl 2 minutes before intubation (P < 0.05).,"[{'ForeName': 'Cheng Yeon', 'Initials': 'CY', 'LastName': 'Teong', 'Affiliation': 'Department of Anesthesiology, MacKay Memorial Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chien-Chung', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, MacKay Memorial Hospital, Taipei, Taiwan, ROC. cchuang@dr.com.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'MacKay Junior College of Medicine, Nursing and Management College, Taipei, Taiwan, ROC.'}]",Scientific reports,['10.1038/s41598-020-65711-9']
1252,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1253,32474728,Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.,"BACKGROUND AND OBJECTIVE


Dabigatran etexilate is a non-vitamin K antagonist oral anticoagulant (NOAC) that is used to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. Pharmacokinetic data on this anticoagulant in Chinese subjects are limited. This study aimed to provide further information on the pharmacokinetic profile of dabigatran in healthy Chinese subjects, together with its safety profile.
METHODS


This was an open-label, single-centre, phase I study. Subjects were randomized into 110 and 150 mg dabigatran etexilate treatment groups. Each subject received 7 days of treatment: a single dose on day 1, no dose on days 2-3, and then multiple doses on days 4-10. Blood samples were collected to analyze the pharmacokinetic profile of dabigatran. All adverse events (AEs) were recorded. Routine clinical laboratory tests, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements were performed.
RESULTS


A total of 28 subjects (14 males and 14 females) were randomized in this trial. The plasma concentration of total dabigatran reached its maximum measured concentration at a median time of 3-4 h from the dose of interest (either the initial single dose on day 1 or the final dose on day 10) under fed conditions, and declined with an elimination half-life of 10.7-10.9 h following the dose of interest. There was a modest difference in pharmacokinetic profile between male and female subjects. None of the subjects experienced a serious adverse event (SAE) or an AE of moderate or severe intensity. The investigator reported that 17 of the 28 subjects had mild treatment-emergent AEs that resolved without any concomitant treatment or intervention. No clinically significant changes in vital signs or ECG parameters were observed.
CONCLUSIONS


This study revealed the pharmacokinetic characteristics and good safety profile of dabigatran in healthy Chinese subjects.",2020,"No clinically significant changes in vital signs or ECG parameters were observed.
","['Chinese subjects', 'Healthy Chinese Subjects', '28 subjects (14 males and 14 females', 'healthy Chinese subjects', 'male and female subjects', 'adults with nonvalvular atrial fibrillation (NVAF']","['vitamin K antagonist oral anticoagulant (NOAC', 'dabigatran etexilate', 'dabigatran', 'Dabigatran Etexilate']","['serious adverse event (SAE) or an AE of moderate or severe intensity', 'plasma concentration of total dabigatran', 'physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements', 'pharmacokinetic profile', 'vital signs or ECG parameters']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",28.0,0.0820733,"No clinically significant changes in vital signs or ECG parameters were observed.
","[{'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China. duanjingli@pkuih.edu.cn.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamura', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00626-4']
1254,32482645,Tapering towards DMARD-free remission in established rheumatoid arthritis: 2-year results of the TARA trial.,"OBJECTIVES


To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
METHODS


This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
RESULTS


189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
CONCLUSION


The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.",2020,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","['189 patients were randomly assigned to tapering their csDMARD (n=94) or', 'patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4\u2009and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor', 'Eligible patients']","['gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate', 'TNF-inhibitor']","['DFR', 'flare rates, DAS or HAQ-DI', 'DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression', 'cumulative flare rate', 'Mean DAS and HAQ-DI over time, and radiographic progression', 'number of disease flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",189.0,0.0797802,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217485']
1255,32479903,Efficacy of antimicrobial photodynamic therapy with chloro-aluminum phthalocyanine on periodontal clinical parameters and salivary GSH and MDA levels in patients with periodontitis.,"The purpose of this study was to evaluate the efficacy of antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClPc) on several periodontal parameters includingsalivary glutathione (GSH) and MDA (malondialdehyde) levels in periodontal sites presenting with periodontitis. Randomized clinical trial, comprising 40 test group (TG) sites and 23 control group (CG) sites. The TG was treated with scaling and root planning (SRP) and aPDT, and CG, only with SRP. Visible plaque index [VPI], gingival bleeding index [GBI], bleeding on probing [BOP], probing depth [PD] and clinical attachment level [CAL] were calculated and saliva samples were taken at baseline (T 0 ), three (T 3 ) and six months (T 6 ). Data was analyzed by the Wilcoxon and Mann-Whitney tests. An intragroup analysis indicated significant differences at T 3  and T 6  for GBI, CAL and GSH only in the CG (p < 0.05). For BOP, a significant decrease was observed only in the TG between T 0  and T 6  (p = 0.008). No significant differences were observed for VPI, BOP and MDA. In the intergroup analysis, significant differences were observed for GBI at T 6  (p = 0.041), and for GSH at T 3  (p = 0.031), being higher in the TG. Although aPDT with AlClPc did not present statistically proven benefits, but the employed periodontal treatment resulted in decreased BOP, PD, CAL and MDA after 3 and 6 months of treatment. In addition, the lower need for glutathione production may initially suggest an additional benefit of AlClPc aPDT in the early reestablishment of the balance between oxidative and non-oxidative agents related to oxidative stress.",2020,"In the intergroup analysis, significant differences were observed for GBI at T 6  (p = 0.041), and for GSH at T 3  (p = 0.031), being higher in the TG.","['patients with periodontitis', 'periodontal sites presenting periodontitis']","['antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClPc', 'scaling and root planning (SRP) and aPDT, and CG', 'antimicrobial photodynamic therapy with chloro-aluminum phthalocyanine']","['Visible plaque index [VPI], gingival bleeding index [GBI], bleeding on probing [BOP], probing depth [PD] and clinical attachment level [CAL', 'several periodontal parameters and salivary glutathione (GSH) and MDA (malondialdehyde) levels', 'periodontal clinical parameters and salivary GSH and MDA levels', 'BOP, PD, CAL and MDA', 'VPI, BOP and MDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0051520', 'cui_str': 'aluminum phthalocyanine'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0042454', 'cui_str': 'Velopharyngeal insufficiency'}]",,0.030644,"In the intergroup analysis, significant differences were observed for GBI at T 6  (p = 0.041), and for GSH at T 3  (p = 0.031), being higher in the TG.","[{'ForeName': 'Davi Neto', 'Initials': 'DN', 'LastName': 'de Araújo Silva', 'Affiliation': 'DDS, MS, PhD Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Natalia Teixeira da', 'Initials': 'NTD', 'LastName': 'Silva', 'Affiliation': 'DDS, Post graduate Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Israel Alexandre de Araújo', 'Initials': 'IAA', 'LastName': 'Sena', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Marcela Letícia da Silva', 'Initials': 'MLDS', 'LastName': 'Azevedo', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Francisco Leonardo da Silva', 'Initials': 'FLDS', 'LastName': 'Júnior', 'Affiliation': 'DDS, MS, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Régia Carla Medeiros da', 'Initials': 'RCMD', 'LastName': 'Silva', 'Affiliation': 'DDS, MS, PhD, Graduation Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Roseane Carvalho', 'Initials': 'RC', 'LastName': 'Vasconcelos', 'Affiliation': 'DDS, MS, PhD, Graduation Student, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Maiara', 'Initials': 'M', 'LastName': 'de Moraes', 'Affiliation': 'DDS, MS, PhD, Professor, Department of Health Sciences, Center for Biological and Health Sciences, Medicine, Federal University Rural of Semi-Árido (UFERSA), Mossoró, Rio Grande do Norte/RN, Brazil.'}, {'ForeName': 'João Paulo Figueiró', 'Initials': 'JPF', 'LastName': 'Longo', 'Affiliation': 'DDS, MS, PhD, Professor, Department of Genetics and Morphology, Institute of Biological Sciences, University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Aurigena Antunes', 'Initials': 'AA', 'LastName': 'de Araújo', 'Affiliation': 'DDS, MS, PhD, Professor, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil.'}, {'ForeName': 'Ana Rafaela Luz', 'Initials': 'ARL', 'LastName': 'de Aquino Martins', 'Affiliation': 'DDS, MS, PhD, Professor, Dentistry Department, Rio Grande do Norte Federal University, Natal, RN, Brazil. Electronic address: anarafaela.luz@terra.com.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101843']
1256,32457492,Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.,"A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.",2020,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","['subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties', 'Treatment-Seeking Alcohol Use Disorder patients with sleeping problems', 'Sixty treatment-seeking AUD subjects']","['Melatonin', 'melatonin', 'placebo']","['sleeping problems', 'global PSQI score', 'sleeping quality', 'Pittsburgh sleep quality index (PSQI) scale']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0808956,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","[{'ForeName': 'Marie N S', 'Initials': 'MNS', 'LastName': 'Gendy', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lagzdins', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Schaman', 'Affiliation': 'Alcohol Research and Treatment Clinic, Acute Care Program, CAMH, Toronto, M6J 1H4, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada. bernard.lefoll@camh.ca.'}]",Scientific reports,['10.1038/s41598-020-65166-y']
1257,32462607,Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO ®  and OTEMTO ®  Studies.,"INTRODUCTION


The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted.
METHODS


TONADO ®  1&2 and OTEMTO ®  1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg tiotropium (LAMA) or 5/5 µg tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI).
RESULTS


Overall, 151 patients received tiotropium; 148 received tiotropium/olodaterol. Mean differences from baseline with tiotropium/olodaterol versus tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV 1 , - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with tiotropium/olodaterol versus tiotropium for trough FEV 1  (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
CONCLUSION


In patients with COPD receiving only LAMA monotherapy, treatment escalation to tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with tiotropium/olodaterol in patients receiving tiotropium alone.
TRIAL REGISTRATION


TONADO ®  1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO ®  2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO ®  1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO ®  2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).",2020,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","['®  2 was registered in the US National Library of Medicine on 10 December 2013', 'patients with COPD receiving only', 'Patients with COPD Receiving only LAMA at Baseline', 'patients receiving tiotropium alone', '®  1 was registered in the US National Library of Medicine on 17 October 2013', 'patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD', 'chronic obstructive pulmonary disease (COPD']","['tiotropium (LAMA) or 5/5\xa0µg tiotropium/olodaterol (LAMA/LABA', 'Tiotropium/Olodaterol', 'muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA', 'tiotropium/olodaterol', 'LAMA monotherapy', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['SGRQ', 'lung function, health status and breathlessness', ""trough forced expiratory volume in 1\xa0s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",,0.511381,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01373-3']
1258,32464266,Efficacy and safety of conventional versus daylight photodynamic therapy in children affected by multiple facial flat warts.,"BACKGROUND


facial flat warts (FFWs) are a superficial viral skin disease, extremely common in childhood. Recently, conventional photodynamic therapy (C-PDT) has been used for the treatment of FFWs with good outcome. The efficacy of daylight photodynamic therapy (DL-PDT) has not yet been evaluated.
OBJECTIVES


to investigate and assess the efficacy and safety of C-PDT versus DL-PDT using 10% aminolevulinic acid (ALA) in the treatment of recalcitrant FFWs in a paediatric setting.
MATERIALS AND METHODS


30 consecutive patients aged <18 years with FFWs of the face were included and randomly divided into two groups: group A (15 patients) was treated with C-PDT and group B (15 patients) with DL-PDT. Patients underwent treatments for three times with 1-month intervals. The response was assessed on week 4,812 and 24 (T4,T8,T12,T24) and scored as excellent (75-100% reduction of total wart count), very good (74-50% reduction), good (49-25% reduction), poor (<25% reduction or no response). Any adverse event occurring during/after ALA application/irradiation as well as pain intensity were recorded at each visit.
RESULTS


at T4 and T8 no excellent response was achieved in both groups. At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response. Excellent outcome raised to 73.3% and 80% in group A and B, respectively, at week 24. Poor response to therapy was observed in 26.7% of patients in group A and 20% in group B. Both treatment modalities were well tolerated, with transient pain, irritation and hyperpigmentation as main side effects.
CONCLUSIONS


ALA-PDT is effective and safe for FFWs, with striking cosmetic results and no recurrence. Compared with conventional modality, DL-PDT is better tolerated, time-saving, nearly painless and greatly appreciated by young patients.",2020,"At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response.","['children affected by multiple facial flat warts', '30 consecutive patients aged <18 years with FFWs of the face']","['C-PDT versus DL-PDT using 10% aminolevulinic acid (ALA', 'conventional modality, DL-PDT', 'daylight photodynamic therapy (DL-PDT', 'conventional photodynamic therapy (C-PDT', 'DL-PDT', 'conventional versus daylight photodynamic therapy', 'C-PDT']","['tolerated, with transient pain, irritation and hyperpigmentation as main side effects', 'pain intensity', 'Efficacy and safety', 'excellent response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}]",30.0,0.0211646,"At week 12, excellent response was observed in 53.3% of group A patients vs 0% of group B patients, although in the latter 66.7% of patients achieved a very good response.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Borgia', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Giuffrida', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy. Electronic address: roberta_giuffrida@hotmail.it.'}, {'ForeName': 'Marialorena', 'Initials': 'M', 'LastName': 'Coppola', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Princiotta', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vaccaro', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Guarneri', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}, {'ForeName': 'Serafinella Patrizia', 'Initials': 'SP', 'LastName': 'Cannavò', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, via Consolare Valeria no 1, Messina 98125, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101819']
1259,32472363,Role of Aspirin for Primary Prevention in Persons with Diabetes Mellitus and in the Elderly.,"PURPOSE OF REVIEW


To review the clinical evidence of the effect of aspirin as primary prevention for patients with diabetes mellitus and in healthy elderly.
RECENT FINDINGS


Two trials were performed to study these two patient populations: ASCEND showed that the use of low-dose aspirin in persons with diabetes, who did not have prior cardiovascular disease, led to a lower risk of cardiovascular events than placebo (8.5% vs 9.6%, rate ratio 0.88, 95% CI 0.79-0.97; p = 0.01). However, it showed a similar magnitude of increased risk of major bleeding among the aspirin group compared with placebo (4.1% vs 3.2%, rate ratio 1.29, 95% CI 1.09-1.52; p = 0.003). ASPREE showed that the use of low-dose aspirin in healthy elderly did not prolong disability-free survival (21.5% vs 21.2%, HR 1.01, 95% CI 0.92-1.11; p = 0.79); however, the rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs 2.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). Additionally, further analyses of secondary end points of death, cardiovascular disease, and major hemorrhage were also studied. Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths. Similar risk of cardiovascular disease was seen among elderly who received aspirin compared with placebo (10.7% vs 11.3%, HR 0.95, 95% CI 0.83-1.08) and resulted in a significantly higher risk of major hemorrhage (8.6% vs 6.8%, HR 1.38, 95% CI 1.18-1.62; p < 0.001). These studies show that the use of low-dose aspirin as primary prevention in patients with diabetes and in the elderly does not have overall beneficial effect compared with its use in secondary prevention. In patients with diabetes without prior cardiovascular disease, the benefits of aspirin use were counterbalanced by the bleeding risk. Additionally, in healthy elderly, the use of aspirin did not prolong disability-free survival and instead led to a higher rate of major hemorrhage.",2020,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","['patients with diabetes mellitus and in healthy elderly', 'Persons with Diabetes Mellitus and in the Elderly', 'patients with diabetes', 'patients with diabetes without prior cardiovascular disease']","['placebo', 'Aspirin', 'aspirin']","['death, cardiovascular disease, and major hemorrhage', 'risk of major bleeding', 'risk of major hemorrhage', 'rate of major hemorrhage', 'disability-free survival', 'Similar risk of cardiovascular disease', 'cause mortality', 'risk of cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.173039,"Higher all-cause mortality was seen among healthy elderly who received aspirin compared with placebo (12.7% vs 11.1%, HR 1.14, 95% CI 1.01-1.29) and was primarily attributed to cancer-related deaths.","[{'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Patel', 'Affiliation': 'University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Ragavendra R', 'Initials': 'RR', 'LastName': 'Baliga', 'Affiliation': 'The Ohio State University Medical Center, Columbus, OH, USA. rrbaliga@gmail.com.'}]",Current cardiology reports,['10.1007/s11886-020-01296-z']
1260,32470147,Effect of non-sedation on post-traumatic stress and psychological health in survivors of critical illness-A substudy of the NONSEDA randomized trial.,"BACKGROUND


Critical illness can cause post-traumatic stress and impaired mental health. The NONSEDA trial was a Scandinavian multicenter RCT, assessing non-sedation versus sedation with a daily wake-up call during mechanical ventilation in critically ill adults. The aim of this substudy was to assess the effect of non-sedation on post-traumatic stress and mental health.
METHODS


This substudy is based on all participating patients from a single NONSEDA trial site (Kolding, Denmark). Patients were randomized to sedation or non-sedation within the first 24 hours of mechanical ventilation. Three months after ICU discharge survivors were examined by a neuropsychologist for post-traumatic stress, anxiety and depression, and filled out the SF-36 questionnaire regarding quality of life.
RESULTS


The two groups of survivors were similar with regard to baseline characteristics, length of admission and mechanical ventilation. Sedated patients received more propofol and midazolam. Doses of morphine and haloperidole were equal.
PRIMARY OUTCOME


the number of patients with post-traumatic stress disorder did not differ between groups (non-sedated: 2 patients vs sedated: 0, P = .23).
SECONDARY OUTCOMES


there were no differences between groups in Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, P = .62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, P = .24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, P = .73) or number of patients with symptoms of post-traumatic stress (8 in both groups, P = .89).
CONCLUSION


Levels of PTSD, anxiety and depression and quality of life regarding mental health were similar between the non-sedated and sedated group.",2020,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","['survivors of critical illness', 'critically ill adults', 'participating patients from a single NONSEDA trial-site (Kolding, Denmark']","['propofol and midazolam', 'morphine', 'non-sedation', 'sedation or non-sedation']","['Beck Anxiety Index', 'number of patients with symptoms of posttraumatic stress', 'Beck Depression Index', 'number of patients with posttraumatic stress disorder', 'PTSD, anxiety and depression and quality of life regarding mental health', 'posttraumatic stress and psychological health', 'SF-36 mental component score']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0854969,"There were no differences between groups in either Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, p=0.62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, p=0.24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, p=0.73) or number of patients with symptoms of posttraumatic stress (8 in both groups, p=0.89).
","[{'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Hanne I', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stylsvig', 'Affiliation': 'Clinic of Neuropsychology, Odense, Denmark.'}, {'ForeName': 'Hanne T', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13648']
1261,32470389,Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study.,"BACKGROUND


Randomized clinical trials have failed to show benefit from increasing intensity of renal replacement therapy (RRT) for acute kidney injury, but continue to be frequently used. In addition, intensive RRT is associated with an increase in adverse events potentially secondary to small solute losses, such as phosphate. We hypothesized that, compared with less-intensive RRT, intensive RRT would lead to longer duration of mechanical ventilation.
RESEARCH QUESTION


Does more-intensive renal replacement therapy in critically ill patients with acute kidney injury increase time to extubation from mechanical ventilation when compared with less-intensive therapy?
STUDY DESIGN AND METHODS


The Acute Renal Failure Trial Network study was a randomized multicenter trial of more-intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 mL/kg per hour) vs less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration at 20 mL/kg per hour) RRT in critically ill patients with acute kidney injury. Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation were included in this Cox-proportional hazards analysis. The primary outcome was the time to first successful extubation off mechanical ventilation.
RESULTS


Patients who were assigned randomly to more-intensive RRT had a 33.3% lower hazard rate of successful extubation (hazard ratio, 0.67; 95% CI, 0.52-0.88; P < .001) when compared with patients who were assigned to less-intensive RRT. Patients who were assigned to more-intensive RRT had, on average, 2.07 ventilator-free days, compared with 3.08 days in those who were assigned to less-intensive RRT (P < .001) over 14 days from start of the study.
INTERPRETATION


Critically ill mechanically ventilated patients who were assigned randomly to more-intensive RRT had longer duration of mechanical ventilation compared with those who were assigned to less-intensive RRT. The reasons for this, such as excessive phosphate loss from more-intensive RRT, deserve further study to optimize the safety and effectiveness of CRRT delivery. This was a post hoc analysis of the Acute Renal Failure Trial Network study; clinical trial registration of the original trial is NCT00076219.",2020,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","['Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation', 'critically ill patients', 'critically ill patients with AKI']","['renal replacement therapy (RRT', 'intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration', 'intensive RRT', 'RRT', 'Renal Replacement Therapy and Duration of Mechanical Ventilation']","['time to first successful extubation off mechanical ventilation', 'hazard rate of successful extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0472688', 'cui_str': 'Continuous venovenous hemodiafiltration'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1124.0,0.192189,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","[{'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, CA; Veterans Affairs, Greater Los Angeles Healthcare System, Los Angeles, CA. Electronic address: shilpasharma@mail.harvard.edu.""}, {'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section, Veterans Affairs Pittsburgh Healthcare System, and the Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Section of Nephrology, Boston University School of Medicine and Boston Medical Center, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.05.542']
1262,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035']
1263,32475183,Does lopinavir measure up in the treatment of COVID-19?,"INTRODUCTION


Lopinavir in combination with ritonavir is approved for the treatment of HIV and has recently been subject to a clinical trial in severe COVID-19.
AREAS COVERED


This evaluation is of LOTUS China (the Lopinavir Trial for Suppression of SARS-Cov-2 in China), which was a randomized trial in hospitalized subjects with COVID-9 in a respiratory sample and pneumonia. As, in severe COVID-19, lopinavir/ritonavir had no beneficial effects but increased gastrointestinal adverse effects, this combination should not be used at this stage of COVID-19.
EXPERT OPINION


In my opinion, the rationale for undertaking a trial of lopinavir/ritonavir in COVID-19 was poor. The analysis of a modified intention to treat group analysis in LOTUS China may have introduced bias. After LOTUS China, there is probably no future for lopinavir in the treatment of severe COVID-19, but some clinical trials for prevention or in various stages of COVID-19 have recently started or are ongoing. The major limitation of these trials is that as lopinavir does not inhibit COVID-19, it is unlikely to prevent infection, reduce viral load, or reduce the severity. However, these trials may be worthwhile in finally determining whether lopinavir has any role in preventing or treating COVID-19.",2020,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.",['hospitalised subjects with Covid-9 in a respiratory sample and pneumonia'],"['lopinavir', 'ritonavir', 'lopinavir/ritonavir']",['gastrointestinal adverse effects'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444279', 'cui_str': 'Respiratory sample'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.148574,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1777277']
1264,32484386,"Pamidronate in chronic non-bacterial osteomyelitis: a randomized, double-blinded, placebo-controlled pilot trial.","OBJECTIVE


This is the first randomized double-blinded, placebo-controlled pilot trial to investigate the efficacy of pamidronate in reducing radiological and clinical disease activity in chronic non-bacterial osteomyelitis (CNO).
METHOD


Patients received pamidronate or placebo at baseline and weeks 12 and 24. Whole-body magnetic resonance imaging was performed at baseline and weeks 12 and 36, and computed tomography of the anterior chest wall (ACW) at baseline and week 36. Radiological disease activity was systematically scored in the ACW and spine. Patient-reported outcomes [visual analogue scale (VAS) pain, VAS global health, Health Assessment Questionnaire (HAQ), EuroQol-5 Dimensions (EQ-5D), and 36-item Short-Form Health Survey (SF-36)] and biomarkers of bone turnover and inflammation were assessed at baseline and weeks 1, 4, 12, 24, and 36. Data are expressed as median [interquartile range].
RESULTS


Fourteen patients were randomized and 12 were analysed. From baseline to week 36, the radiological disease activity score in the ACW decreased from 5 [4-7] to 2.5 [1-3] in the pamidronate group, but did not change in the placebo group (p = 0.04). From baseline to week 36, VAS pain and VAS global health tended to decrease more in the pamidronate than in the placebo group (p = 0.11, p = 0.08). Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change. Biomarkers of bone turnover decreased only in the pamidronate group (p ≤ 0.02).
CONCLUSION


Pamidronate may improve radiological and clinical disease activity in CNO. Methods to score radiological disease activity in adult CNO were suggested. Clinical Trials: NCT02594878.",2020,"Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change.","['chronic non-bacterial osteomyelitis (CNO', 'Fourteen patients were randomized and 12 were analysed', 'chronic non-bacterial osteomyelitis']","['placebo', 'pamidronate or placebo', 'pamidronate', 'Pamidronate']","['radiological disease activity score', 'VAS pain and VAS global health', 'Radiological disease activity', 'Biomarkers of bone turnover', 'outcomes [visual analogue scale (VAS) pain, VAS global health, Health Assessment Questionnaire (HAQ), EuroQol-5 Dimensions (EQ-5D), and 36-item Short-Form Health Survey (SF-36)]\xa0and biomarkers of bone turnover and inflammation', 'Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0410422', 'cui_str': 'Chronic multifocal osteomyelitis'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}]","[{'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",14.0,0.488638,"Physical functioning (HAQ) and health-related quality of life (EQ-5D, SF-36) did not change.","[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Andreasen', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Jurik', 'Affiliation': 'Department of Radiology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Deleuran', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Horn', 'Affiliation': 'Department of Rheumatology, Odense University Hospital , Odense, Denmark.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Folkmar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aarhus University Hospital , Aarhus, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Herlin', 'Affiliation': 'Department of Clinical Medicine, Aarhus University , Aarhus, Denmark.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Hauge', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital , Aarhus, Denmark.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1724324']
1265,32488885,Effect of 3 Single Doses of Trazodone on QTc Interval in Healthy Subjects.,"This study evaluated the effect of 3 doses of a trazodone hydrochloride 6% oral drops solution on the QT interval of healthy volunteers. Subjects were randomly assigned to receive a single dose of trazodone 20 mg, 60 mg, and 140 mg, moxifloxacin 400 mg, and trazodone-matched placebo in 5 periods separated by 7-day washouts, according to a double-blind, crossover study design. Subjects were monitored continuously, and triplicate ECGs were extracted from baseline (predose) until 24 hours postdose. Blood samples for trazodone and moxifloxacin analyses were collected at the same time points. The concentration-QTc relationship assessed on placebo-adjusted change from baseline for Fridericia-corrected QT (ΔΔQTcF) was the primary end point. ΔΔQTcF values of 4.5, 12.3, and 19.8 ms for the 20-, 60-, and 140-mg doses were observed at the corresponding trazodone peak plasma concentrations. The upper bound of the 90%CI exceeded 10 ms for the 60- and the 140-mg doses. Time-matched analysis results were in line with these findings. No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present. In this moxifloxacin-validated ECG trial, trazodone had a modest, dose-dependent effect on cardiac repolarization, with no QTc prolongation observed with the 20-mg dose and an effect exceeding the values set in E14 guideline with the 60- and 140-mg doses. The effect on cardiac repolarization is unlikely to represent a clinical risk for ventricular proarrhythmia, but caution should be used with concomitant use of other medications that prolong QT or increase trazodone exposure.",2020,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"['healthy volunteers', 'Healthy Subjects']","['trazodone 20\xa0mg, 60\xa0mg, and 140\xa0mg, moxifloxacin 400\xa0mg, and trazodone-matched placebo', 'trazodone', 'trazodone hydrochloride 6% oral drops solution', 'Trazodone', 'moxifloxacin']","['concentration-QTc relationship', 'ΔΔQTcF values', 'heart rate or PR or QRS intervals', 'cardiac repolarization']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C1273616', 'cui_str': 'Oral drops solution'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.0666214,No significant trazodone effect on heart rate or PR or QRS intervals and no clinically significant new morphological changes were present.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tellone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}, {'ForeName': 'Milko', 'Initials': 'M', 'LastName': 'Radicioni', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Leuratti', 'Affiliation': 'Cross Research SA, Arzo, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': 'Angelini SpA, Piazzale della Stazione, Pomezia, Italy.'}]",Journal of clinical pharmacology,['10.1002/jcph.1640']
1266,32483161,Efficacy and safety of artemisinin-based combination therapy and the implications of Pfkelch13 and Pfcoronin molecular markers in treatment failure in Senegal.,"In 2006, Senegal adopted artemisinin-based combination therapy (ACT) as first-line treatment in the management of uncomplicated malaria. This study aimed to update the status of antimalarial efficacy more than ten years after their first introduction. This was a randomized, three-arm, open-label study to evaluate the efficacy and safety of artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) in Senegal. Malaria suspected patients were screened, enrolled, treated, and followed for 28 days for AL and ASAQ arms or 42 days for DP arm. Clinical and parasitological responses were assessed following antimalarial treatment. Genotyping (msp1, msp2 and 24 SNP-based barcode) were done to differentiate recrudescence from re-infection; in case of PCR-confirmed treatment failure, Pfk13 propeller and Pfcoronin genes were sequenced. Data was entered and analyzed using the WHO Excel-based application. A total of 496 patients were enrolled. In Diourbel, PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR) was 100.0% in both the AL and ASAQ arms. In Kedougou, PCR corrected ACPR values were 98.8%, 100% and 97.6% in AL, ASAQ and DP arms respectively. No Pfk13 or Pfcoronin mutations associated with artemisinin resistance were found. This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.",2020,"This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.","['treatment failure in Senegal', '496 patients were enrolled', 'Senegal', 'Malaria suspected patients were screened, enrolled, treated, and followed for 28 days for AL and ASAQ arms or 42 days for DP arm']","['Senegal adopted artemisinin-based combination therapy (ACT', 'artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP', 'artemisinin-based combination therapy']","['antimalarial efficacy', 'Clinical and parasitological responses', 'Efficacy and safety', 'PCR corrected ACPR values', 'efficacy and safety', 'PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR']","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4750349', 'cui_str': 'Malaria suspected'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}]",496.0,0.0471766,"This study showed that AL, ASAQ and DP remain efficacious and well-tolerated in the treatment of uncomplicated P. falciparum malaria in Senegal.","[{'ForeName': 'Mamadou Alpha', 'Initials': 'MA', 'LastName': 'Diallo', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal. mamadoualpha.diallo@ucad.edu.sn.'}, {'ForeName': 'Mamadou Samb', 'Initials': 'MS', 'LastName': 'Yade', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Yaye Die', 'Initials': 'YD', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Diallo', 'Affiliation': 'National Malaria Control Program (NMCP), Rue Aimé Césaire, Fann Résidence, Dakar, Senegal.'}, {'ForeName': 'Khadim', 'Initials': 'K', 'LastName': 'Diongue', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Saidou Abdoul', 'Initials': 'SA', 'LastName': 'Sy', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mouhamad', 'Initials': 'M', 'LastName': 'Sy', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mame Cheikh', 'Initials': 'MC', 'LastName': 'Seck', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Mouhamadou', 'Initials': 'M', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Baba', 'Initials': 'B', 'LastName': 'Dieye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Jules François', 'Initials': 'JF', 'LastName': 'Gomis', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Djiby', 'Initials': 'D', 'LastName': 'Sow', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Awa Bineta', 'Initials': 'AB', 'LastName': 'Dème', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Aida Sadikh', 'Initials': 'AS', 'LastName': 'Badiane', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}, {'ForeName': 'Daouda', 'Initials': 'D', 'LastName': 'Ndiaye', 'Affiliation': 'Department of Parasitology and Mycology, Cheikh Anta Diop University, Avenue Cheikh Anta Diop, BP 5005 Fann, Dakar, Senegal.'}]",Scientific reports,['10.1038/s41598-020-65553-5']
1267,32483272,Measuring Cancer Hallmark Mediation of the TET1 Glioma Survival Effect with Linked Neural-Network Based Mediation Experiments.,"This paper examines the effect of TET1 expression on survival in glioma patients using open-access data from the Genomic Data Commons. A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%. A synthetic experiment was then conducted that linked two separately trained neural networks: a multitask model estimating cancer hallmark gene expression from TET1 expression, and a survival neural network. This experiment quantified the mediation of the TET1 survival effect through eight cancer hallmarks: apoptosis, cell cycle, cell death, cell motility, DNA repair, immune response, two phosphorylation pathways, and a randomized gene sets. Immune response, DNA repair, and apoptosis displayed greater mediation than the randomized gene set. Cell motility was inversely associated with only 12.5% mediated concordance. We propose the neural network linkage mediation experiment as an approach to collecting evidence of hazard mediation relationships with prognostic capacity useful for designing interventions.",2020,A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%.,['glioma patients using open-access data from the Genomic Data Commons'],['TET1 expression'],['Cell motility'],"[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0205214', 'cui_str': 'Common'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0007608', 'cui_str': 'Motility, Cell'}]",,0.094776,A neural network-based survival model was built on expression data from a selection of genes most affected by TET1 knockdown with a median cross-validated survival concordance of 82.5%.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Luechtefeld', 'Affiliation': 'Insilica LLC, 2736 Quarry Heights Way, Baltimore, MD, USA.'}, {'ForeName': 'Nole', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': 'Insilica LLC, 2736 Quarry Heights Way, Baltimore, MD, USA.'}, {'ForeName': 'Channing', 'Initials': 'C', 'LastName': 'Paller', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kuhns', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Laterra', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Bressler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. bressler@kennedykrieger.org.'}]",Scientific reports,['10.1038/s41598-020-65369-3']
1268,32491152,Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention.,"BACKGROUND


Self-monitoring is a key component of behavioral weight loss (BWL) interventions. Past research suggests that individuals may avoid self-monitoring in certain contexts (e.g., skipping self-weighing after higher-than-usual calorie intake). However, no studies have attempted to quantify individuals' inclination to avoid information about their weight control (""weight-related information avoidance""; WIA) or prospectively examined its implications for treatment engagement and outcomes in BWL programs.
PURPOSE


Characterize WIA using a validated questionnaire among adults enrolled in BWL treatment and examine whether WIA prospectively predicts self-monitoring adherence, session attendance, treatment discontinuation, or weight loss.
METHODS


Participants (N = 87; MBMI = 34.9 kg/m2, 83% female) completed a measure of WIA prior to starting a 12 week, group-based BWL intervention. Participants were given digital self-monitoring tools and instructed to self-monitor their food intake daily, physical activity daily, and body weight weekly (Weeks 1-10) and then daily (Weeks 11-12). Session attendance and treatment discontinuation were recorded. Weight was measured in-clinic pretreatment and posttreatment.
RESULTS


While mean WIA was low (M = 2.23, standard deviation [SD] = 0.95; potential scale range: 1-7), greater WIA predicted poorer attendance (r = -.23; p = .03) and poorer self-monitoring of physical activity (r = -.28; p = .009) and body weight (r = -.32; p = .003). WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
CONCLUSIONS


Greater WIA, as assessed via a brief questionnaire, may place individuals at risk for poorer self-monitoring and treatment engagement during BWL. Further research on the implications of WIA in the context of weight management is warranted, including evaluation of correlates, moderators, and mechanisms of action of WIA.
CLINICAL TRIAL REGISTRATION


NCT03337139.",2020,"WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
","['adults enrolled in BWL treatment', 'Participants (N = 87; MBMI = 34.9 kg/m2, 83% female']",[],"['body weight', 'poorer self-monitoring of physical activity', 'Weight-Related Information Avoidance', 'Weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0202255,"WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91).
","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, RI, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Martinelli', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Convertino', 'Affiliation': 'San Diego State University/University of California San Diego, Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa034']
1269,32488010,Motor imagery training speeds up gait recovery and decreases the risk of falls in patients submitted to total knee arthroplasty.,"With Motor imagery (MI), movements are mentally rehearsed without overt actions; this procedure has been adopted in motor rehabilitation, primarily in brain-damaged patients. Here we rather tested the clinical potentials of MI in purely orthopaedic patients who, by definition, should maximally benefit of mental exercises because of their intact brain. To this end we studied the recovery of gait after total knee arthroplasty and evaluated whether MI combined with physiotherapy could speed up the recovery of gait and even limit the occurrence of future falls. We studied 48 patients at the beginning and by the end of the post-surgery residential rehabilitation program: half of them completed a specific MI training supported by computerized visual stimulation (experimental group); the other half performed a non-motoric cognitive training (control group). All patients also had standard physiotherapy. By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain. The number of falls or near falls after surgery was significantly lower in the experimental group. These results show that MI can improve gait abilities and limit future falls in orthopaedic patients, without collateral risks and with limited costs.",2020,"By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain.","['All patients also had standard physiotherapy', 'patients submitted to total knee arthroplasty', '48 patients at the beginning and by the end of the post-surgery residential rehabilitation program']","['MI combined with physiotherapy', 'Motor imagery (MI', 'specific MI training supported by computerized visual stimulation (experimental group); the other half performed a non-motoric cognitive training (control group']","['recovery of gait and active knee flexion-extension movements, and less pain', 'gait abilities and limit future falls', 'risk of falls', 'number of falls or near falls after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",48.0,0.0174975,"By the end of the rehabilitation, the experimental group showed a better recovery of gait and active knee flexion-extension movements, and less pain.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zapparoli', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy. laura.zapparoli@unimib.it.'}, {'ForeName': 'Lucia Maria', 'Initials': 'LM', 'LastName': 'Sacheli', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Seghezzi', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Preti', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Stucovitz', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Negrini', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Pelosi', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ursino', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Eraldo', 'Initials': 'E', 'LastName': 'Paulesu', 'Affiliation': 'Psychology Department and NeuroMI - Milan Center for Neuroscience, University of Milano-Bicocca, Milan, Italy. eraldo.paulesu@unimib.it.'}]",Scientific reports,['10.1038/s41598-020-65820-5']
1270,32488923,Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26-week PRONTO-T1D study.,"AIMS


To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26-week, treat-to-target, phase 3 trial.
MATERIALS AND METHODS


After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n = 451) or lispro (n = 442), or open-label post-meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non-inferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions after a meal test.
RESULTS


Both mealtime and post-meal URLi demonstrated non-inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi -0.08% [95% confidence interval (CI) -0.16, 0.00] and for post-meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post-meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1- and 2-hour PPG excursions during the meal test: ETD -1.55 mmol/L (95% CI -1.96, -1.14) at 1 hour and - 1.73 mmol/L (95% CI -2.28, -1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post-meal URLi, and 0.2% on lispro. Overall, the incidence of treatment-emergent adverse events was similar between treatments.
CONCLUSIONS


The results showed that URLi provided good glycaemic control, with non-inferiority to lispro confirmed for both mealtime and post-meal URLi, while superior PPG control was demonstrated with mealtime dosing.",2020,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","['adults with type 1 diabetes', 'Patients With Type 1 Diabetes']","['ultra rapid lispro (URLi) versus lispro', 'Ultra Rapid Lispro', 'double-blind mealtime URLi (n=451) or lispro (n=442), or open-label postmeal URLi', 'Lispro']","['Postprandial Glucose Control', 'incidence of treatment-emergent adverse events', 'rate and incidence of severe, documented and postprandial hypoglycaemia', 'Injection site reactions', 'postprandial glucose (PPG) excursions', '1- and 2-h PPG excursions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0271710', 'cui_str': 'Reactive hypoglycemia'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",,0.0808552,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Klaff', 'Affiliation': 'Rainier CRC, Renton, Washington, USA.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tobian', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Dahl', 'Affiliation': 'Gemeinschaftspraxis fur Innere Medizin und Diabetologie, Hamburg, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Lucas Research, Morehead City, North Carolina, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14100']
1271,32488989,Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.,"The aim of this phase 1 study was to determine the effects of sapanisertib on the heart rate-corrected QT (QTc) interval in patients with advanced solid tumors. Adult patients with advanced solid tumors were enrolled to receive a single sapanisertib 40-mg dose. Blood samples for pharmacokinetic analysis were collected and electrocardiogram readings were recorded at baseline and up to 48 hours after dosing. Patients could continue to receive sapanisertib 30 mg once weekly in 28-day cycles for up to 12 months. The primary objective was to characterize the effect of a single dose of sapanisertib (40 mg) on the QT interval. Secondary objectives were to evaluate safety, tolerability, and pharmacokinetics. Following a single sapanisertib 40-mg dose in 44 patients, the maximum least squares mean (upper bound of 1-sided 95% confidence interval) changes from time-matched baseline were 7.1 milliseconds (11.4 milliseconds) for individual rate-corrected QT interval at 24 hours after dosing, and 1.8 milliseconds (5.6 milliseconds) for Fridericia-corrected QTc at 1 hour post-dose. There was no sapanisertib plasma concentration-dependent increase in the change from time-matched baseline individual rate-corrected QTc interval or Fridericia-corrected QTc. The most common adverse events following sapanisertib 30 mg once-weekly dosing were nausea (80%), fatigue (61%), vomiting (57%), and decreased appetite (45%). A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors. The safety profile of sapanisertib 30 mg once weekly was favorable, and no new safety signals were observed (NCT02197572, clinicaltrials.gov).",2020,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"['Adult patients with advanced solid tumors', 'Patients With Advanced Solid Tumors', 'patients with advanced solid tumors']",['sapanisertib'],"['QTc interval', 'fatigue', 'safety, tolerability, and pharmacokinetics', 'sapanisertib plasma concentration', 'appetite', 'vomiting', 'nausea', 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.278022,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rangachari', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jayson D', 'Initials': 'JD', 'LastName': 'Wilbur', 'Affiliation': 'Metrum Research Group, LCC, Connecticut, USA.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'A Craig', 'Initials': 'AC', 'LastName': 'Lockhart', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.808']
1272,32489539,Early Outcomes of Medial Pivot Total Knee Arthroplasty Compared to Posterior-Stabilized Design: A Randomized Controlled Trial.,"Backgroud


The indications for total knee arthroplasty (TKA) have been expanded to include younger, demanding patients. Some TKA patients expect a return to high-performance activities to restore optimum quality of life. The concept of the medial pivot (MP) TKA is that more natural knee kinematics can be achieved by altering the bearing design. In the present study, we compared the early outcomes of MP TKA with posterior-stabilized (PS) TKA in terms of patient-reported outcomes, function, and performance.
Methods


This randomized study was performed in a high volume joint replacement facility of a tertiary care military hospital. We enrolled 40 patients each in the MP group and PS group and assessed knee flexion, patient-reported outcome (new Knee Society Score [new KSS]), patient performance (Delaware Osteoarthritis Profile Score [DOPS]), and function (Forgotten Joint Score [FJS]) at 2 years after surgery.
Results


Compared to PS group patients, MP group patients had similar patient-reported outcomes assessed by new KSS (satisfaction, expectation, and activity scales) and FJS. MP knee patients had better performance in the timed up and go test ( p  < 0.026) and self-paced walk test ( p  < 0.002) of DOPS. The gain in knee flexion (9.3° ± 14°) compared to baseline was significantly greater in the PS group ( p  < 0.013).
Conclusions


When assessed by DOPS, getting up from chair and walking speed were significantly better in MP knee patients than in PS knee patients. However, considering the predictable rollback ensured by cam and post, the PS knee produced better knee flexion. Despite these results, patients were equally satisfied with the two designs.",2020,MP knee patients had better performance in the timed up and go test ( p  < 0.026) and self-paced walk test ( p  < 0.002) of DOPS.,"['total knee arthroplasty (TKA', 'high volume joint replacement facility of a tertiary care military hospital']","['MP TKA with posterior-stabilized (PS) TKA', 'Medial Pivot Total Knee Arthroplasty Compared to Posterior-Stabilized Design']","['DOPS, getting up from chair and walking speed', 'new KSS (satisfaction, expectation, and activity scales) and FJS', 'knee flexion, patient-reported outcome (new Knee Society Score [new KSS]), patient performance (Delaware Osteoarthritis Profile Score [DOPS]), and function (Forgotten Joint Score [FJS', 'knee flexion', 'gain in knee flexion']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522485', 'cui_str': 'Patient performance'}, {'cui': 'C0011198', 'cui_str': 'Delaware'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}]",40.0,0.100327,MP knee patients had better performance in the timed up and go test ( p  < 0.026) and self-paced walk test ( p  < 0.002) of DOPS.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Kulshrestha', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandigarh, India.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Sood', 'Affiliation': 'Department of Orthopaedics, Command Hospital, Chandigarh, India.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Department of Orthopaedics, Dr Shyama Prasad Mukherjee Hospital, Lucknow, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics and Joint Replacement, Command Hospital Air Force, Bengaluru, India.'}, {'ForeName': 'Barun', 'Initials': 'B', 'LastName': 'Datta', 'Affiliation': 'Department of Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Department of Orthopaedics, Military Hospital, Kilkee, India.'}]",Clinics in orthopedic surgery,['10.4055/cios19141']
1273,31806872,Randomized post-induction and delayed intensification therapy in high-risk pediatric acute lymphoblastic leukemia: long-term results of the international AIEOP-BFM ALL 2000 trial.,,2020,,['high-risk pediatric acute lymphoblastic leukemia'],['Randomized post-induction and delayed intensification therapy'],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023452', 'cui_str': 'Lymphoblastic Leukemia, Acute, Childhood'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0277782,,"[{'ForeName': 'Andishe', 'Initials': 'A', 'LastName': 'Attarbaschi', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. andishe.attarbaschi@stanna.at.""}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Mann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': ""Department of Children and Adolescent Medicine, Children's Hospital, Goethe University, Frankfurt, Germany.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barisone', 'Affiliation': ""Pediatric Onco-Hematology, Regina Margherita Children's Hospital, AOU Città della Salute e della Scienza, Turin, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Basso', 'Affiliation': 'Italian Institute for Genomic Medicine, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Cario', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Cazzaniga', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Colombini', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Flotho', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Albert Ludwigs University, Freiburg, Germany.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kuhlen', 'Affiliation': ""University Children's Hospital Augsburg, Swabian Children's Cancer Center, Augsburg, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Eberhard Karls University, Tübingen, Germany.""}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Lauten', 'Affiliation': ""Department of Pediatric and Adolescent Medicine, Children's Hospital, University of Lübeck, Lübeck, Germany.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Linderkamp', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Department of Pediatric Hematology-Oncology, IRCCS ""Bambino Gesù"" Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lo Nigro', 'Affiliation': 'Center of Pediatric Hematology Oncology, Azienda Policlinico-OVE, Catania, Italy.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Möricke', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Department of Pediatric Oncology, University Children's Hospital, Zürich, Switzerland.""}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Panzer-Grümayer', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Parasole', 'Affiliation': 'Department of Pediatric Hemato-Oncology, A.O.R.N. Santobono-Pausilipon, Naples, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caterina Putti', 'Affiliation': 'Department of Woman and Child Health, Clinic of Pediatric Haematology-Oncology, University of Padova, Padova, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rizzari', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Suttorp', 'Affiliation': 'Department of Pediatrics, Pediatric Hemato-Oncology Unit, Children\'s Hospital, University Hospital ""Carl Gustav Carus"", Dresden, Germany.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Valsecchi', 'Affiliation': 'Center of Biostatistics for Clinical Epidemiology, Department of Health Science, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Valentino', 'Initials': 'V', 'LastName': 'Conter', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-019-0670-y']
1274,32485095,"Differential effects of testosterone on circulating neutrophils, monocytes, and platelets in men: Findings from two trials.","BACKGROUND


Testosterone treatment increases erythrocytes in men, but its effects on leukocyte and platelet counts are unknown and could affect its safety.
OBJECTIVE


To determine whether testosterone affects circulating leukocytes and platelets in men.
METHODS


Secondary analyses of two randomized testosterone trials were performed: the 5α-reductase (5aR) and OPTIMEN trials. In 5aR trial, 102 healthy men, 21-50 years (mean age 38), received a long-acting GnRH agonist, and 50, 125, 300, or 600 mg/week testosterone enanthate (TE) plus placebo or 2.5 mg /  day dutasteride for 20 weeks. In OPTIMEN, 78 functionally limited men, ≥65 years (mean age 72) with protein intake ≤ 0.83 g kg -1   day -1  , were randomized to controlled diets with 0.8 g kg -1   day -1  protein or 1.3 g kg -1   day -1  protein plus placebo or TE (100 mg/week) for 6 months. Changes from baseline in total and differential leukocyte count, and platelet count were evaluated.
RESULTS


In 5aR, testosterone administration was associated with increases in total leukocyte (estimated change from baseline 40, 490, 1230, and 1280 cells/µL, P < .001), neutrophil (65.1, 436.1, 1177.2, and 1192.2 cells/µL, P < .001), monocyte (-20.2, 24.5, 90.6, and 143.9 cells/µL, P < .001), platelet (-7.3, 8.4, 8.7, and 8.9 × 10 3  cells/µL, P = .033), and erythrocyte counts. Testosterone did not affect absolute lymphocyte count. Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77 × 10 3  cells/µL, P vs placebo = 0.004).
CONCLUSIONS


Testosterone administration in men differentially increases neutrophil and monocyte counts. These findings, together with its erythropoietic effects, suggest that testosterone promotes the differentiation of hematopoietic progenitors into the myeloid lineage. These findings have potential mechanistic, therapeutic, and safety implications.",2020,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"['78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g *  kg -1   *  day -1', 'men', '102 healthy men, 21-50 years (mean age 38', 'Men']","['controlled diets with 0.8 g *  kg -1   *  day -1  protein or 1.3 g *  kg -1   *  day -1  protein plus placebo or TE', 'testosterone', 'Testosterone', 'enanthate (TE) plus placebo', '5α-Reductase (5aR']","['total and differential leukocyte count, and platelet count', 'monocyte', 'total leukocyte', 'total leukocyte count', 'Peripheral Neutrophils, Monocytes and Platelets', 'platelet', 'neutrophil and monocyte counts', 'absolute lymphocyte count', 'neutrophil', 'erythrocyte counts']","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0019226', 'cui_str': 'Enanthates'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162401', 'cui_str': 'Differential white blood cell count procedure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",102.0,0.505029,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Andrology,['10.1111/andr.12834']
1275,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES


Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.
METHODS


Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.
RESULTS


188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.
CONCLUSIONS


This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863']
1276,32581009,Use of Aspirin and Statins in Relation to Inflammation in Benign Prostate Tissue in the Placebo Arm of the Prostate Cancer Prevention Trial.,"Aspirin and statin use may lower the risk of advanced/fatal prostate cancer, possibly by reducing intraprostatic inflammation. To test this hypothesis, we investigated the association of aspirin and statin use with the presence and extent of intraprostatic inflammation, and the abundance of specific immune cell types, in benign prostate tissue from a subset of men from the placebo arm of the Prostate Cancer Prevention Trial. Men were classified as aspirin or statin users if they reported use at baseline or during the 7-year trial. Presence and extent of inflammation were assessed, and markers of specific immune cell types (CD4, CD8, FoxP3, CD68, and c-KIT) were scored, in slides from end-of-study prostate biopsies taken irrespective of clinical indication, per trial protocol. Logistic regression was used to estimate associations between medication use and inflammation measures, adjusted for potential confounders. Of 357 men included, 61% reported aspirin use and 32% reported statin use. Prevalence and extent of inflammation were not associated with medication use. However, aspirin users were more likely to have low FoxP3, a T regulatory cell marker [OR, 5.60; 95% confidence interval (CI), 1.16-27.07], and statin users were more likely to have low CD68, a macrophage marker (OR, 1.63; 95% CI, 0.81-3.27). If confirmed, these results suggest that these medications may alter the immune milieu of the prostate, which could potentially mediate effects of these medications on advanced/fatal prostate cancer risk.",2020,Prevalence and extent of inflammation were not associated with medication use.,"['benign prostate tissue from a subset of men from the placebo arm of the Prostate Cancer Prevention Trial', 'Men were classified as aspirin or statin users if they reported use at baseline or during the seven-year trial', 'Of 357 men included, 61% reported aspirin use and 32% reported statin use']","['aspirin and statin', 'aspirin', 'Aspirin and statin', 'Aspirin and Statins']","['specific immune cell types (CD4, CD8, FoxP3, CD68, c-KIT']","[{'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0072470', 'cui_str': 'Lymphocyte antigen CD117'}]",357.0,0.0896527,Prevalence and extent of inflammation were not associated with medication use.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Kulac', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Berrak', 'Initials': 'B', 'LastName': 'Gumuskaya', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Javier A Baena Del', 'Initials': 'JABD', 'LastName': 'Valle', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Benedetti', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Jun O', 'Initials': 'JO', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacology and Molecular Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Marrone', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Hospital Medical Center, San Antonio, Texas.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Isaacs', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Nelson', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Platz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. eplatz1@jhu.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0450']
1277,32485743,"Letter to the Editor from Melanson et al (second letter): ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.01543,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa350']
1278,32485778,Whole-body Electromyostimulation plus Caloric Restriction in Metabolic Syndrome.,"We investigated early effects of Whole-Body Electromyostimulation added to hypocaloric diet on metabolic syndrome features in sedentary middle-aged individuals. We randomly assigned 25 patients to Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone for 26 weeks. Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein were assessed. Body composition was evaluated with direct-segmental, multi-frequency Bioelectrical Impedance Analysis. Both groups lost approximately 10% of weight, with similar effects on waist circumference and fat mass. Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03). Whole-Body Electromyostimulation plus caloric restriction group experienced greater percent reductions in insulin (-45.5±4.4 vs. -28.2±3.6%, p=0.002), HOMA-IR (-51.3±3.2 vs. -25.1±1.8%, p=0.001), triglycerides (-22.5±2.9 vs. -4.1±1.6%, p=0.004) and triglycerides/HDL (p=0.028). Subjects trained with Whole-Body Electromyostimulation had also significant improvement in systolic pressure (138±4 vs. 126±7 mmHg, p=0.038). No discontinuations for adverse events occurred. In middle-aged sedentary subjects with the metabolic syndrome, Whole-Body Electromyostimulation with caloric restriction for 26 weeks can improve insulin-resistance and lipid profile compared to diet alone. Further studies are needed to ascertain long-term efficacy and feasibility of this approach in individuals with the metabolic syndrome.",2020,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","['middle-aged sedentary subjects with the metabolic syndrome', 'Metabolic Syndrome', 'individuals with the metabolic syndrome', 'sedentary middle-aged individuals']","['Whole-Body Electromyostimulation plus caloric restriction or caloric restriction alone', 'Whole-Body Electromyostimulation added to hypocaloric diet']","['triglycerides', 'insulin-resistance and lipid profile', 'systolic pressure', 'metabolic syndrome features', 'waist circumference and fat mass', 'Body composition', 'HOMA-IR', 'free-fat mass', 'triglycerides/HDL', 'adverse events', 'Anthropometrics, blood pressure, fasting glucose and insulin, HOMA-IR, glycated hemoglobin, lipids, uric acid, creatinphosphokynase, C-reactive protein']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",25.0,0.0367421,"Change in free-fat mass was significantly different between groups (caloric restriction -1.5±0.2 vs. Whole-Body Electromyostimulation plus caloric restriction +1.1±0.4 kg, p=0.03).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Bellia', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ruscello', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Bolognino', 'Affiliation': 'Sapienza University of Rome, Unitelma Sapienza, Roma, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Briotti', 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Paolo Roberto', 'Initials': 'PR', 'LastName': 'Gabrielli', 'Affiliation': 'School of Sports and Exercise Sciences , University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'Urban Fitness EMS Institute, Urban Fitness, Milano, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rosazza', 'Affiliation': 'Fondazione IRCCS Istituto Neurologico ""Carlo Besta"", Neuroradiology Dept., Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ambruoso', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Lombardo', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, Telematic University San Raffaele Rome Srl, Roma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernardini', 'Affiliation': 'Faculty of Medicine and Surgery, School of Sports and Exercise Sciences, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Calabrese', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lauro', 'Affiliation': 'Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'Ottavio"", 'Affiliation': 'School of Sports and Exercise Sciences, Telematic University San Raffaele Rome Srl, Roma, Italy.'}]",International journal of sports medicine,['10.1055/a-1171-2003']
1279,32586176,"Re: Health Care Hotspotting-A Randomized, Controlled Trial.",,2020,,[],[],[],[],[],[],,0.217515,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171.02']
1280,32583313,"Allisartan Isoproxil Improves Endothelial Function and Vascular Damage in Patients with Essential Hypertension: A Single-Center, Open-Label, Randomized Controlled Trial.","INTRODUCTION


Allisartan isoproxil is a novel angiotensin II type 1 receptor antagonist that has been confirmed to lower blood pressure and protect target organs effectively. However, its role in improving endothelial function and vascular damage has not been investigated yet.
METHODS


Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99 mmHg) with age from 25-75 years were randomly assigned 1:1 to either the allisartan group (allisartan 240 mg/day and lifestyle modification) or the lifestyle modification group and were followed up for 30 days. Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage. In addition, we enrolled 36 normotensive individuals as healthy control.
RESULTS


Seventy-two mildly hypertensive patients were enrolled in this study. After 30 days of treatment, a significant increase in FMD was observed in the allisartan group (0.9 ± 0.7%, p < 0.001) and remained unchanged in the lifestyle modification group, but the difference between the two groups did not reach statistical significance (p = ns). EMPs, baPWV, SBP and DBP decreased by 251.0 ± 255.9 counts/μl (p < 0.001), 102.8 ± 84.2 cm/s (p < 0.001), 13.20 ± 3.9 mmHg (p < 0.001) and 9.35 ± 2.5 mmHg (p < 0.001), respectively, in the allisartan group, while by 21.3 ± 84.3 counts/μl (p = ns), 0.4 ± 22.0 cm/s (p = ns), 3.2 ± 6.0 mmHg (p < 0.01) and 1.0 ± 2.5 mmHg (p = ns), respectively, in the lifestyle modification group. All of the indexes above achieved statistical significance between the allisartan and lifestyle modification groups (p < 0.05). Besides, after 30 days of allisartan administration baPWV and EMPs were comparable to those measured in the healthy control group, while the difference in SBP, DBP and FMD remained significant between the allisartan and healthy control groups (p < 0.05).
CONCLUSION


The present study demonstrates for the first time that allisartan isoproxil exerts a favorable effect on improving endothelial function and vascular damage in patients with mild EH, making it a promising drug for management of EH.
CLINICAL TRIAL REGISTRATION


ChiCTR2000032332.",2020,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","['patients with mild EH', 'Seventy-two mildly hypertensive patients', 'Patients with Essential Hypertension', 'Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99\xa0mmHg) with age from 25-75\xa0years', '36 normotensive individuals as healthy control']","['allisartan group (allisartan 240\xa0mg/day and lifestyle modification) or the lifestyle modification', 'Allisartan Isoproxil']","['EMPs, baPWV, SBP and DBP', 'Endothelial Function and Vascular Damage', 'FMD', 'SBP, DBP and FMD', 'Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial\xa0microparticles (EMPs', 'endothelial function and vascular damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3849367', 'cui_str': 'allisartan isoproxil'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",36.0,0.0670531,"Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage.","[{'ForeName': 'Gaoxing', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuanya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China. taojungz123@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01413-y']
1281,32586526,Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.,"OBJECTIVE


To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial.
STUDY DESIGN


In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models.
RESULTS


Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
CONCLUSIONS


In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.",2020,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","['250 white, non-Hispanic participants with Marfan syndrome', 'Marfan Syndrome', 'children and young adults with Marfan syndrome']","['atenolol vs losartan', 'losartan', 'Atenolol and Losartan', 'atenolol']","['atenolol response', 'rate of improvement in aortic root z-score', 'rate of improvement', 'baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3\xa0years, assessed using mixed effects models']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",52.0,0.139844,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gelb', 'Affiliation': 'Mindich Child Health and Development Institute, Departments of Pediatrics and Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shaine A', 'Initials': 'SA', 'LastName': 'Morris', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Dietz', 'Affiliation': 'Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Howard Hughes Medical Institute, Baltimore, MD.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Forbus', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics University of Pennsylvania Perlman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Hoskoppal', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ""Department of Pediatrics, Section of Cardiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Loeys', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Josephina A N', 'Initials': 'JAN', 'LastName': 'Meester', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mital', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mosley', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'Center for Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sharkey', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, MO.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.064']
1282,32588071,Invited Discussion on: Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,,2020,,['Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],[],,0.0915365,,"[{'ForeName': 'Maurice Y', 'Initials': 'MY', 'LastName': 'Nahabedian', 'Affiliation': 'Virginia Commonwealth University, Inova Branch, National Center for Plastic Surgery, 7601 Lewinsville Dr., #400, McLean, VA, 22102, USA. DrNahabedian@aol.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01839-3']
1283,32583557,Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).,"BACKGROUND


The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial.
METHODS


The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed.
RESULTS


The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs.
CONCLUSIONS


Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy.
CLINICAL TRIAL REGISTRATION


NCT02105636.",2020,"The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively.","['patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN', ""34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed"", 'Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141']",['nivolumab'],"['adverse events (TRAEs), including skin-related disorders', '2-year survival', 'prolonged OS benefits', 'median overall survival (OS', '2-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",34.0,0.0661625,"The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively.","[{'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Hanai', 'Affiliation': 'Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yokota', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shigemichi', 'Initials': 'S', 'LastName': 'Iwae', 'Affiliation': 'Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Ruey-Long', 'Initials': 'RL', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Jin-Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Wing Sum Kenneth', 'Initials': 'WSK', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Section 1, Oncology Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Vijayvel', 'Initials': 'V', 'LastName': 'Jayaprakash', 'Affiliation': 'Oncology Clinical Development, BMS, Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Head & neck,['10.1002/hed.26331']
1284,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE


Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS


Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION


Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
1285,32586177,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001171']
1286,32588891,Risk of Secondary Traumatic Stress in Treating Traumatized Military Populations: Results from the PTSD Clinicians Exchange.,"INTRODUCTION


This study examined risk factors for secondary traumatic stress (STS) in behavioral health clinicians and whether access to the Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange website mitigated STS risk.
METHODS


A diverse sample of clinicians (N = 605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings were randomized to a newsletter-only control group or the exchange group. The exchange website included resources for treating PTSD and promoting clinician well-being. Online surveys were administered at 0-, 6-, and 12-months postrandomization. Regression analyses were used to examine the link among risk factors, exchange access, and STS.
RESULTS


Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs if required were not linked with STS at the 12-month assessment period. Providing care at the VA, more burnout, less compassion satisfaction, greater trauma caseload, less openness to new EBPs, and greater divergence from EBP procedures were linked with greater STS. Only burnout and divergence were associated with STS after accounting for other significant STS risk factors. Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
CONCLUSIONS


Given that burnout was linked with STS, future intervention may use techniques targeting burnout and STS (eg, emotion regulation strategies). Research exploring the link between divergence from EBPs and STS may inform EBP dissemination efforts and STS interventions. Finally, results highlight the need for research optimizing STS intervention efficacy among clinicians treating military populations.",2020,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
","['Treating Traumatized Military Populations', 'A diverse sample of clinicians (N\xa0=\xa0605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings']",[],"['Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs', 'STS levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",605.0,0.0367443,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Penix', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Clarke-Walper', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Palo Alto Veterans Institute for Research, 3801 Miranda Avenue, Palo Alto, CA 94304.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Wilk', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}]",Military medicine,['10.1093/milmed/usaa078']
1287,32588919,Progressive resistance training for adolescents with cerebral palsy: the STAR randomized controlled trial.,"AIM


To evaluate the effect of progressive resistance training of the ankle plantarflexors on gait efficiency, activity, and participation in adolescents with cerebral palsy (CP).
METHOD


Sixty-four adolescents (10-19y; 27 females, 37 males; Gross Motor Function Classification System [GMFCS] levels I-III) were randomized to 30 sessions of resistance training (10 supervised and 20 unsupervised home sessions) over 10 weeks or usual care. The primary outcome was gait efficiency indicated by net nondimensional oxygen cost (NNcost). Secondary outcomes included physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness. Analysis was intention-to-treat.
RESULTS


Median attendance at the 10 supervised sessions was 80% (range 40-100%). There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158). There was also no evidence of between-group differences in secondary outcomes at 10 or 22 weeks. There were 123 adverse events reported by 27 participants in the resistance training group.
INTERPRETATION


We found that 10 supervised sessions and 20 home sessions of progressive resistance training of the ankle plantarflexors did not improve gait efficiency, muscle strength, activity, participation, or any biomechanical outcome among adolescents with CP.
WHAT THIS PAPER ADDS


Thirty sessions of progressive resistance training of the ankle plantarflexors over 10 weeks did not improve gait efficiency among ambulatory adolescents with cerebral palsy. Resistance training did not improve muscle strength, activity, or participation. Ninety percent of participants experienced an adverse event. Most adverse events were expected and no serious adverse events were reported.",2020,"There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158).","['adolescents with cerebral palsy (CP', 'adolescents with CP', 'Sixty-four adolescents (10-19y; 27 females, 37 males', 'adolescents with cerebral palsy']","['progressive resistance training', 'resistance training (10 supervised and 20 unsupervised home sessions', 'Progressive resistance training']","['gait efficiency, muscle strength, activity, participation, or any biomechanical outcome', 'gait efficiency, activity, and participation', 'gait efficiency indicated by net nondimensional oxygen cost (NNcost', 'Median attendance', 'physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",,0.106891,"There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ryan', 'Affiliation': 'Department of Public Health and Epidemiology, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Theis', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Noorkoiv', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Korff', 'Affiliation': 'Research and Development, Frogbikes, Ascot, UK.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Baltzopoulos', 'Affiliation': 'Research Institute for Sport and Exercises Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shortland', 'Affiliation': ""One Small Step Gait Laboratory, Guy's Hospital, London, UK.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Levin', 'Affiliation': 'Department of Physiotherapy, Swiss Cottage School and Development and Research Centre, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Developmental medicine and child neurology,['10.1111/dmcn.14601']
1288,32588971,A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment.,"INTRODUCTION


Recent studies suggest that Alzheimer's disease (AD) biomarker disclosure has no discernable psychological impact on cognitively healthy persons. Far less is known about how such results affect symptomatic individuals and their caregivers.
METHODS


Randomized controlled trial of 82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164) to determine the effect of receiving amyloid positron emission tomography results on understanding of, and perceived efficacy to cope with, MCI over 52 weeks of follow-up.
RESULTS


Gains in the primary outcomes were not consistently observed. Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive. There was no corresponding increase in depressive symptoms.
DISCUSSION


These findings point to the possibility that both MCI patients and caregivers may need emotional support after the disclosure of amyloid scan results.",2020,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","['mild cognitive impairment', '82 mild cognitive impairment (MCI) patient and caregiver dyads (total n = 164', 'cognitively healthy persons']",['amyloid positron emission tomography'],"['sustained emotional distress', 'depressive symptoms']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",82.0,0.143392,"Amyloid negative patients reported greater perceived ambiguity regarding MCI at follow-up, while moderate and sustained emotional distress was observed in patients, and to a lesser extent, caregivers, of those who were amyloid positive.","[{'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lingler', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Meryl A', 'Initials': 'MA', 'LastName': 'Butters', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Klunk', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Knox', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'McDade', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University, St. Louis, Missouri, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Roberts', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Tamres', 'Affiliation': 'Department of Health and Community Systems, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': ""Alzheimer's Disease Research Center, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12129']
1289,32586190,"Re: The Daily Therapy with L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study.",,2020,,['Erectile Dysfunction'],"['L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy']",[],"[{'cui': 'C0242350', 'cui_str': 'Impotence'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}]",[],,0.018511,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001167.03']
1290,32589939,Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial.,"PURPOSE


We aimed to compare complication rates and functional outcomes in patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity.
PATIENTS AND METHODS


This international, multicenter randomized controlled trial included adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis. Patients were treated with either a combination of rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation for both fractures. The primary outcome was complications within 6 weeks after surgery. Secondary outcomes were complications within 3 months, Helkimo dysfunction index, and mandibular mobility at 6 weeks and 3 months after surgery.
RESULTS


Of the 315 patients enrolled, 158 were randomized to the mixed fixation group and 157 to the nonrigid fixation group. The overall complication rate at 6 weeks in the intention-to-treat population was 9.6% (95% confidence interval [CI], 5.3% to 15.6%) in the mixed fixation group and 7.8% (95% CI, 4.0% to 13.5%) in the nonrigid fixation group. With an unadjusted odds ratio of 1.25 (95% CI, 0.51 to 3.17), there were no statistically significant differences in complication rates between the 2 groups (P = .591). A multivariable model for complication risk at 6 weeks found no significant differences between treatment groups, but patients with moderate or severe displacement had a higher complication rate than those with no or minimal displacement (adjusted odds ratio, 4.58; 95% CI, 1.16 to 18.06; P = .030). There were no significant between-group differences in complication rates at 3 months. Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
CONCLUSIONS


A combination of rigid and nonrigid fixation in patients with bilateral mandibular fracture has similar complication rates and functional outcomes to nonrigid fixation for both fractures.",2020,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","['patients with bilateral mandibular fractures treated with different degrees of internal fixation rigidity', 'adults with bilateral mandibular fractures located at either the angle and body, angle and symphysis, or body and symphysis', 'patients with bilateral mandibular fracture', '315 patients enrolled', 'Bilateral Mandibular Fractures']","['rigid fixation for the anterior fracture and nonrigid fixation for the posterior fracture (mixed fixation) or nonrigid fixation', 'nonrigid fixation group', 'rigid and nonrigid fixation', 'Rigid and Nonrigid Fixation Versus Nonrigid Fixation']","['complication rates', 'Helkimo dysfunction index and mandibular mobility index', 'complication risk', 'overall complication rate', 'complications within 6\xa0weeks after surgery', 'complication rate', 'complications within 3\xa0months, Helkimo dysfunction index, and mandibular mobility', 'complication rates and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",315.0,0.151617,"Moreover, no significant differences in Helkimo dysfunction index and mandibular mobility index at 6 weeks and 3 months were found between groups according to treatment allocated and treatment received.
","[{'ForeName': 'Vivesh', 'Initials': 'V', 'LastName': 'Rughubar', 'Affiliation': 'Head, Clinical Unit, Maxillofacial and Oral Surgery, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Vares', 'Affiliation': 'Professor, Head, and Chair of Surgical Dentistry & Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Priyadeshni', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Dentist, Department of Oral and Maxillofacial Surgery, King Edward VIII Hospital, Durban, South Africa.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Filipsky', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Creanga', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Hospital Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Alkhalil', 'Affiliation': 'Head, Department Oral and Maxillofacial Surgery and CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Kormi', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Päijät-Häme Central Hospital, Päijät-Häme Joint Authority of Health and Wellbeing, Lahti, Finland (currently), and, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Hanken', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Asklepios Hospital North, Faculty of Medicine, Semmelweis University Campus Hamburg, Hamburg, Germany (currently), and Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alvaro Rivero', 'Initials': 'AR', 'LastName': 'Calle', 'Affiliation': 'Consultant, Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Wenko', 'Initials': 'W', 'LastName': 'Smolka', 'Affiliation': 'Senior Surgeon, Department of Oral & Maxillofacial Surgery, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Turner', 'Affiliation': 'Chief of Oral and Maxillofacial Surgery, Division of Oral and Maxillofacial Surgery, Mount Sinai Hospital, New York City, NY.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csáki', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Ministry of Defense Health Centre, Budapest, Hungary.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Sánchez-Aniceto', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, University Hospital 12 Octubre de Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez', 'Affiliation': 'Associate Professor and Program Director, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Carl-Peter', 'Initials': 'CP', 'LastName': 'Cornelius', 'Affiliation': 'Associate Professor, Ludwig-Maximilians University, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie, Munich, Germany.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alani', 'Affiliation': 'Specialist, CranioMaxilloFacial Surgery/Head and Neck Surgery Department, Hamad Medical, Doha, Qatar.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vlad', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Emergency County Hospital, Constanta, Romania.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kontio', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Professor and Chair of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, The University of Texas Health Science Center at San Antonio, San Antonio, TX. Electronic address: ellise3@uthscsa.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.05.012']
1291,32589613,Cognitive enhancement of healthy older adults using hyperbaric oxygen: a randomized controlled trial.,"More than half of community-dwelling individuals sixty years and older express concern about declining cognitive abilities. The current study's aim was to evaluate hyperbaric oxygen therapy (HBOT) effect on cognitive functions in healthy aging adults.A randomized controlled clinical trial randomized 63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months. Primary endpoint included the general cognitive function measured post intervention/control. Cerebral blood flow (CBF) was evaluated by perfusion magnetic resonance imaging.There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017). The most striking improvements were in attention (net effect size=0.745) and information processing speed (net effect size=0.788).Voxel-based analysis showed significant cerebral blood flow increases in the HBOT group compared to the control group in the right superior medial frontal gyrus (BA10), right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8) and the right superior parietal gyrus (BA7).In this study, HBOT was shown to induce cognitive enhancements in healthy aging adults via mechanisms involving regional changes in CBF. The main improvements include attention, information processing speed and executive functions, which normally decline with aging.",2020,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"['63 healthy adults (>64) either to HBOT(n=33) or control arms(n=30) for three months', 'healthy older adults', 'healthy aging adults']","['hyperbaric oxygen', 'hyperbaric oxygen therapy (HBOT']","['global cognitive function post-HBOT', 'attention, information processing speed and executive functions, which normally decline with aging', 'Cerebral blood flow (CBF', 'right and left supplementary motor area (BA6), right middle frontal gyrus (BA6), left middle frontal gyrus (BA9), left superior frontal gyrus (BA8', 'cognitive functions', 'general cognitive function measured post intervention/control', 'cerebral blood flow increases']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",63.0,0.0790879,There was a significant group-by-time interaction in global cognitive function post-HBOT compared to control (p=0.0017).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Daniel-Kotovsky', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Suzin', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Rahav', 'Initials': '', 'LastName': 'Boussi-Gross', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Catalogna', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Dagan', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Hachmo', 'Affiliation': 'Research and Development Unit, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Ramzia', 'Initials': 'R', 'LastName': 'Abu Hamed', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Sasson', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fishlev', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Lang', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Polak', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Doenyas', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Mony', 'Initials': 'M', 'LastName': 'Friedman', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tal', 'Affiliation': 'Radiology Department, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Zemel', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bechor', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Efrati', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin, Israel.'}]",Aging,['10.18632/aging.103571']
1292,32591464,A Phase II Study of Allogeneic GM-CSF-Transfected Pancreatic Tumor Vaccine (GVAX) with Ipilimumab as Maintenance Treatment for Metastatic Pancreatic Cancer.,"PURPOSE


This phase II study tested granulocyte-macrophage colony-stimulating factor (GM-CSF)-allogeneic pancreatic tumor cells (GVAX) and ipilimumab in metastatic pancreatic ductal adenocarcinoma (PDA) in the maintenance setting.
PATIENTS AND METHODS


Patients with PDA who were treated with front-line chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible. Patients were randomized 1:1 to treatment with GVAX and ipilimumab given every 3 weeks for four doses then every 8 weeks (Arm A) or to FOLFIRINOX continuation (Arm B). The primary objective was to compare overall survival (OS) between the two arms.
RESULTS


Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42). The study was stopped for futility after interim analysis. Median OS was 9.38 months [95% confidence interval (CI), 5.0-12.2] for Arm A and 14.7 months (95% CI, 11.6-20.0) for Arm B (HR, 1.75;  P  = 0.019). Using immune-related response criteria, two partial responses (5.7%) were observed in Arm A and four (13.8%) in Arm B. GVAX + ipilimumab promoted T-cell differentiation into effector memory phenotypes both in the periphery and in the tumor microenvironment and increased M1 macrophages in the tumor.
CONCLUSIONS


GVAX and ipilimumab maintenance therapy did not improve OS over continuation of chemotherapy and resulted in a numerically inferior survival in metastatic PDA. However, clinical responses and biological effects on immune cells were observed. Further study of novel combinations in the maintenance treatment of metastatic PDA is feasible.",2020,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","['metastatic pancreatic ductal adenocarcinoma (PDA', 'Patients with PDA who were treated with front-line chemotherapy consisting of', 'FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible', 'Metastatic Pancreatic Cancer', 'Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42']","['GVAX and ipilimumab', 'Ipilimumab', 'Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX', '5-fluorouracil, leucovorin, irinotecan, and oxaliplatin', 'granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells (GVAX) and ipilimumab']","['Median overall survival (OS', 'overall survival (OS', 'M1 macrophages']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",82.0,0.0811801,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","[{'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bever', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Won Jin', 'Initials': 'WJ', 'LastName': 'Ho', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Niu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Parkinson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Ferguson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Wilt', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, UCSF Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Department of Internal Medicine, Division of Oncology at Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thompson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1025']
1293,32591475,"Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial.","OBJECTIVE


We evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).
METHODS


In this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model;  p  values were not used for hypothesis testing.
RESULTS


An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).
CONCLUSIONS


Natalizumab administered ≤24 hours after AIS did not improve patient outcomes.
CLINICALTRIALSGOV IDENTIFIER


NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.",2020,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"['patients with AIS', 'acute ischemic stroke (AIS) patients', 'AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites']","['Natalizumab', 'placebo (natalizumab', 'natalizumab or placebo, with randomization stratified by treatment window ', 'natalizumab', 'placebo']","['serious adverse events', 'deaths', 'patient outcomes', 'composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.783971,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"[{'ForeName': 'Mitchell S V', 'Initials': 'MSV', 'LastName': 'Elkind', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA. mse13@columbia.edu.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Kasliwal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}]",Neurology,['10.1212/WNL.0000000000010038']
1294,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND


Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported.
OBJECTIVES


To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors.
METHODS


Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used.
RESULTS


Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001).
CONCLUSIONS


Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Baroni', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Carantoni', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319']
1295,32593323,"Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.","BACKGROUND


Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs.
METHODS


In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing.
FINDINGS


Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; p non-inferiority =0·034, p superiority =0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; p non-inferiority =0·0058, p superiority =0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups.
INTERPRETATION


The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves.
FUNDING


Abbott.",2020,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","['high and extreme risk patients with severe aortic stenosis (PORTICO IDE', '1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369', 'risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia', 'Mean age was 83 years (SD 7) and 395 (52·7%) patients were female', 'Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis', 'Eligible patients']","['self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA', 'transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT', 'Self-expanding intra-annular versus commercially available transcatheter heart valves']","['event rate', 'intention to treat and the Kaplan-Meier method to estimate event rates', 'cause mortality or disabling stroke', 'disabling stroke', 'composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days', 'safety and efficacy', 'rates of death', 'Clinical outcomes and valve performance', 'rates of death or disabling stroke', 'rates of the primary efficacy endpoint']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C4302018', 'cui_str': 'Bleeding requiring transfusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.297403,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","[{'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: raj.makkar@cshs.org.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Groh', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abernethy', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Russo', 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heimansohn', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hermiller', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Worthley', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, SA, Australia; Genesis Care, Sydney, NSW, Australia.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Chehab', 'Affiliation': 'Cardiovascular Research Institute of Kansas, Ascension Via Christi Hospital, Wichita, KS, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cunningham', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Matthews', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Ramana', 'Affiliation': 'Advocate Christ Medical Center, Oak Lawn, IL, USA; Heart Care Centers of Illinois, Palos Park, IL, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Yong', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Ruiz', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, Washington, DC, USA.'}, {'ForeName': 'Mamoo', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Jilaihawi', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Sung-Han', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Augusto D', 'Initials': 'AD', 'LastName': 'Pichard', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Fontana', 'Affiliation': 'Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31358-1']
1296,32592335,Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.,"OBJECTIVES


Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions.
MATERIAL AND METHODS


Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups.
RESULTS


There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients.
CONCLUSIONS


Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.",2020,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","['Twenty-seven patients with OLP, were enrolled in two groups']","['Mycophenolate mofetil (MMF', 'Oral lichen planus (OLP', 'MMF mucoadhesive', 'mucoadhesive mycophenolate mofetil patch']","['burning sensation and lesion size', 'lesion size on control sides', 'burning sensation and pain severity and ulcer size of ulcerative OLP', 'severity of burning sensation and pain by visual analogue scale (VAS; cm', 'Lesion size', 'pain and burning sensation and lesion size', 'side effects']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",27.0,0.0435425,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Samiee', 'Affiliation': 'Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghavi Zenuz', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Mehdipour', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.302']
1297,32590555,"In response to: A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, NONFLAIL fracture patterns (Chest Wall Injury Society NONFLAIL).",,2020,,"['patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0272434', 'cui_str': 'Injury of chest wall'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",[],[],,0.017272,,"[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Elkbuli', 'Affiliation': 'Division of Trauma and Surgical Critical Care Department of Surgery Kendall Regional Medical Center Miami, Florida.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baroutjian', 'Affiliation': ''}, {'ForeName': 'Shaikh', 'Initials': 'S', 'LastName': 'Hai', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002845']
1298,32592912,In vitro evaluation of the effectiveness of bleaching agents activated by KTP and Nd:YAG laser.,"AIM


To compare two different laser sources, a KTP laser with a wavelength of 532 nm and a Nd:YAG laser with a wavelength of 1064 nm, to investigate the relation between laser source and bleaching gel during laser irradiation.
METHODS


Extracted human teeth were stained and randomly divided into six groups. Two in-office bleaching gels, Beyond and Opalescence Boost, were applied to stained teeth and then irradiated at either 532 nm or 1064 nm. The temperature change of pulp chamber was measured. The color change (ΔE*) was evaluated at the following time points: immediately after bleaching, 7, 14 and 30 days after the end of bleaching.
RESULTS


Boost irradiated by KTP laser showed the higher temperature increase when compared with Beyond irradiated KTP and Nd:YAG. Boost irradiated by Nd:YAG presented lower temperature increase than by KTP. All groups showed a certain color change. After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05). At each time point, Boost activated by KTP laser showed higher ΔE* value compared with other groups (p < 0.05), but decreased significantly 15 days after the end of bleaching. The other groups showed a relatively small change in ΔE* value after 30 days (p > 0.05).
CONCLUSIONS


KTP laser achieved better results than the Nd:YAG laser regarding tooth color change when associated with the Opalescence Boost bleaching gels.",2020,"After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05).",['Extracted human teeth'],"['bleaching, Nd:YAG laser irradiation', 'KTP laser with a wavelength of 532\u2009nm and a Nd:YAG laser', 'Bleaching Agents Activated by KTP and Nd:YAG laser', 'Boost irradiated by Nd:YAG', 'KTP laser']",['temperature change of pulp chamber'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C2936259', 'cui_str': 'Whitening Agents'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}]","[{'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0034099', 'cui_str': 'Pulp chamber of tooth'}]",,0.0166658,"After bleaching, Nd:YAG laser irradiation did not increase the ΔE* value significantly compared with gels without laser (p >  0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China. Electronic address: d.du565@163.com.'}, {'ForeName': 'Zhuoping', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'School and Hospital of Stomatology, Shanxi Medical University, Taiyuan, China. Electronic address: 784246283@qq.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China. Electronic address: 601564009@qq.com.'}, {'ForeName': 'Kuanshou', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Quantum Optics and Quantum Optics Devices, Institute of Opto-Electronics, Shanxi University, Taiyuan, China. Electronic address: kuanshou@sxu.edu.cn.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Taiyuan, China; School and Hospital of Stomatology, Shanxi Medical University, Taiyuan, China. Electronic address: liuqingmei2006@sina.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101900']
1299,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1300,32594567,A computer-guided quality improvement tool for primary health care: cost-effectiveness analysis based on TORPEDO trial data.,"OBJECTIVE


To assess the cost-effectiveness of a computer-guided quality improvement intervention for primary health care management of cardiovascular disease (CVD) in people at high risk.
DESIGN


Modelled cost-effectiveness analysis of the HealthTracker intervention and usual care for people with high CVD risk, based on TORPEDO trial data on prescribing patterns, changes in intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores.
PARTICIPANTS


Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size.
INTERVENTION


HealthTracker, integrated into health care provider electronic health record systems, provides real time decision support, risk communication, a clinical audit tool, and a web portal for performance feedback.
MAIN OUTCOME MEASURES


Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker.
RESULTS


The estimated numbers of major CVD events over five years per 1000 patients at high CVD risk were lower in PHNs using HealthTracker, both for patients with prior CVD events (secondary prevention; 259 v 267 with usual care) and for those without prior events (primary prevention; 168 v 176). Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention. The estimated ICER for one averted CVD event was $7406 for primary prevention and $17 988 for secondary prevention.
CONCLUSION


Modelled cost-effectiveness analyses provide information that can assist decisions about investing in health care quality improvement interventions. We estimate that HealthTracker could prevent major CVD events for less than $20 000 per event averted.
TRIAL REGISTRATION (TORPEDO)


Australian New Zealand Clinical Trials Registry, ACTRN 12611000478910.",2020,Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention.,"['primary health care', 'primary health care management of cardiovascular disease (CVD) in people at high risk', 'people with high CVD risk', 'Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size']","['computer-guided quality improvement intervention', 'HealthTracker intervention and usual care']","['Medication costs', 'estimated numbers of major CVD events', 'major CVD events', 'intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores', 'Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker', 'cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",,0.109009,Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention.,"[{'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'Sydney Medical School, the University of Sydney, Sydney, NSW.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Panaretto', 'Affiliation': 'Centre for Chronic Disease, University of Queensland, Brisbane, QLD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}]",The Medical journal of Australia,['10.5694/mja2.50667']
1301,32594612,Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials.,"Direct-acting antiviral treatments for chronic hepatitis C virus (HCV) infection are generally safe; however, understanding the safety profile of each regimen is essential for their continued use. Safety data were pooled from 12 clinical trials of elbasvir/grazoprevir (EBR/GZR) that enrolled adult participants with HCV infection. Pooled analyses are presented for participants receiving EBR/GZR for 12 weeks and those receiving EBR/GZR plus ribavirin (RBV) for 16-18 weeks. Safety data are also presented for participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD] or receiving opioid agonist therapy [OAT]). Among 1743 participants receiving EBR/GZR for 12 weeks, 1068 (61.3%) reported ≥1 adverse event (AE) and 491 had AEs (28.2%) considered drug-related. The most frequent AEs were headache (10.6%), fatigue (8.7%), nasopharyngitis (5.8%), nausea (5.1%) and diarrhoea (5.0%). Serious AEs were reported by 37 participants (2.1%), and 12 (0.7%) discontinued treatment due to an AE. In populations with CKD 4/5 or IBLD or receiving OAT, safety was similar in participants receiving EBR/GZR for 12 weeks and those receiving placebo. Some AEs occurred at higher frequencies in participants receiving RBV compared with those receiving EBR/GZR alone: fatigue (32.7% vs 8.7%); headache (21.6% vs 10.6%); and nausea (15.8% vs 5.1%). Safety was similar in participants with and those without cirrhosis. Grade 3/4 alanine aminotransferase elevations were reported in 0.7% participants. EBR/GZR is a safe treatment option for individuals with HCV genotype (GT) 1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and those receiving OAT.",2020,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","['participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD', '1743 participants receiving', 'participants with and those without cirrhosis', 'enrolled adult participants with HCV infection']","['opioid agonist therapy [OAT', 'Direct-acting antiviral treatments', 'EBR/GZR plus ribavirin (RBV', 'elbasvir/grazoprevir', 'EBR/GZR', 'elbasvir/grazoprevir (EBR/GZR', 'placebo']","['headache', 'diarrhea', 'Safety and tolerability', 'Safety', 'fatigue', '≥1 adverse event (AE', 'IBLD or receiving OAT, safety', 'Grade 3/4 alanine aminotransferase elevations', 'nasopharyngitis', 'nausea']","[{'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1743.0,0.0643241,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","[{'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Nangia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vierling', 'Affiliation': 'Departments of Medicine and Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwo', 'Affiliation': 'Department of Medicine-Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Klopfer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Robertson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Haber', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'K Rajender', 'Initials': 'KR', 'LastName': 'Reddy', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13357']
1302,32594305,Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.,"BACKGROUND AND OBJECTIVE


Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.
METHODS


Infants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.
RESULTS


Seventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.
CONCLUSIONS


A single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.
CLINICAL TRIAL REGISTER


ClinicalTrials.gov Identifier: NCT00226044.",2020,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"['3\xa0kg) with EA or CDH and GERD', 'Infants', 'Seventeen infants, 4 with EA and 13 with CDH, were included', 'infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH', 'Infants (6-12\xa0weeks postnatal and bodyweight ', 'infants', 'With Gastroesophageal Reflux Disease', 'infants with pathological GERD']","['omeprazole', 'Rectal Omeprazole', 'Omeprazole', 'omeprazole rectally or orally', 'rectal omeprazole']","['efficacy and pharmacokinetics', 'percentages of time that gastric pH', 'intraesophageal and gastric pH', 'number of reflux episodes of pH', 'total reflux time']","[{'cui': 'C0014850', 'cui_str': 'Congenital atresia of esophagus'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C2959898', 'cui_str': 'Intraesophageal route'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.126466,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bestebreurtje', 'Affiliation': 'Department of Clinical Pharmacology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Barbara A E', 'Initials': 'BAE', 'LastName': 'de Koning', 'Affiliation': 'Division of Pediatric Gastroenterology, Department of Pediatrics, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Nel', 'Initials': 'N', 'LastName': 'Roeleveld', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Catherijne A J', 'Initials': 'CAJ', 'LastName': 'Knibbe', 'Affiliation': 'Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'van Groen', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Cees P', 'Initials': 'CP', 'LastName': 'van de Ven', 'Affiliation': 'Department of Pediatric Surgery, Prinses Maxima Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Frans B', 'Initials': 'FB', 'LastName': 'Plötz', 'Affiliation': 'Department of Pediatrics, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Saskia N', 'Initials': 'SN', 'LastName': 'de Wildt', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands. Saskia.deWildt@radboudumc.nl.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00630-8']
1303,32602177,A 6 month extension trial evaluating safety and efficacy of ferric derisomaltose in patients with iron deficiency anemia: The FERWON-EXT trial.,,2020,,['patients with iron deficiency anemia'],['ferric derisomaltose'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}]",[],,0.0746263,,"[{'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Divison of Hematology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'Department of Medicine, Division of Hematology Oncology, UCLA School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, District of Columbia, USA.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-Clinical Research, Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Kingston upon Hull, UK.'}]",American journal of hematology,['10.1002/ajh.25920']
1304,32598060,The Effect of a Skin Barrier Film on the Incidence of Dressing-Related Skin Blisters After Spine Surgery.,"Tension blisters from adhesive dressings may lead to pain and delayed surgical wound healing for surgical patients and cause an institutional cost burden. Commercial skin barrier film products may reduce dressing-related postoperative skin blistering in surgical patients. Project investigators at an orthopedic specialty hospital randomized 185 surgical spine patients to receive either a standard wound dressing (ie, control group) or a dressing with the addition of a skin barrier film applied beneath it (eg, treatment group). During the first postoperative dressing change, the participants' skin was assessed for redness, soreness, blistering, or tearing. Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98). Multivariable analyses did not indicate the skin barrier film provided a protective effect. Additionally, there was no association between patient-specific characteristics and skin blisters among the participants. These results do not support the use of a skin barrier film in surgical spine patients.",2020,Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98).,"['surgical spine patients', '185 surgical spine patients', 'surgical patients']","['standard wound dressing (ie, control group) or a dressing with the addition of a skin barrier film applied beneath it', 'Skin Barrier Film', 'Commercial skin barrier film products']","['postoperative skin injury', 'redness, soreness, blistering, or tearing', 'Incidence of Dressing-Related Skin Blisters', 'patient-specific characteristics and skin blisters']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",185.0,0.0325508,Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98).,"[{'ForeName': 'Maryanne', 'Initials': 'M', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Vlad', 'Affiliation': ''}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Golenbock', 'Affiliation': ''}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Sorrentino', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13074']
1305,32598090,Effect of information and exercise programmes after lumbar disc surgery: A randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare two physiotherapy interventions following lumber disc surgery regarding effect on pain, functioning and fear of movement.
METHODS


This study is a prospective randomized controlled study. When admitted to hospital for first time lumbar disc surgery, the participants were randomized to one of two post-operative intervention groups: one group received information only and the other exercise in combination with information. Outcomes were collected at baseline, 6-8 weeks and 12-months post-surgery. The primary outcome was to record changes in back/hip pain and leg pain. Secondary outcomes were evaluation of changes in function, fear-avoidance beliefs and kinesiophobia.
RESULTS


Seventy patients completed the study and were included in the analysis, of which 37 were randomized to the group receiving information only and the remaining 33 receiving both exercise and information. For primary outcomes, at 12 months postoperatively, the group receiving both exercise and information had significantly lower leg pain compared with those receiving only information (p < .033). For secondary outcomes, at 12 months postoperatively, a significant difference (p < .027) was detected for function, which favoured those that received both exercise and information. There was no significant difference in the results for the other secondary outcomes. Both groups showed clinically important changes in relation to pain and function from baseline to 12 months. The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
CONCLUSION


Exercise in combination with information reduced leg pain and improved function, which was statistically more evident over a period of time. Postoperative physiotherapy after lumbar disc surgery could include exercises in addition to information, but perhaps not for all patients, as both groups improved, and the difference between the two groups was not clinically relevant.",2020,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
","['lumbar disc surgery', 'Seventy patients completed the study and were included in the analysis, of which 37']","['information and exercise programmes', 'information only and the other exercise in combination with information']","['leg pain', 'record changes in back/hip pain and leg pain', 'leg pain and improved function', 'pain, functioning and fear of movement', 'evaluation of changes in function, fear-avoidance beliefs and kinesiophobia']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",37.0,0.202768,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant.
","[{'ForeName': 'Eva Saltskår', 'Initials': 'ES', 'LastName': 'Jentoft', 'Affiliation': 'Orthopedic Clinic Kysthospitalet in Hagevik, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kvåle', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vegard Pihl', 'Initials': 'VP', 'LastName': 'Moen', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1864']
1306,32601120,Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes.,"OBJECTIVE


To report 5-year outcomes from the subthalamic nucleus (STN) deep brain stimulation (DBS) in early-stage Parkinson disease (PD) pilot clinical trial.
METHODS


The pilot was a prospective, single-blind clinical trial that randomized patients with early-stage PD (Hoehn & Yahr II off medications) to receive bilateral STN DBS plus optimal drug therapy (ODT) vs ODT alone (IDEG050016, NCT0282152, IRB040797). Participants who completed the 2-year trial participated in this observational follow-up study, which included annual outpatient visits through 5 years. This analysis includes 28 patients who were taking PD medications for 6 months to 4 years at enrollment. Outcomes were analyzed using both proportional odds logistic regression and linear mixed effects models.
RESULTS


Early STN DBS + ODT participants required lower levodopa equivalent daily doses ( p  = 0.04, β = -240 mg, 95% confidence interval [CI] -471 to -8) and had 0.06 times the odds of requiring polypharmacy at 5 years compared to early ODT participants ( p  = 0.01, odds ratio [OR] 0.06, 95% CI 0.00 to 0.65). The odds of having worse rest tremor for early STN DBS + ODT participants were 0.21 times those of early ODT participants ( p  < 0.001, OR 0.21, 95% CI 0.09 to 0.45). The safety profile was similar between groups.
CONCLUSIONS


These results suggest that early DBS reduces the need for and complexity of PD medications while providing long-term motor benefit over standard medical therapy. Further investigation is warranted, and the Food and Drug Administration has approved the conduct of a prospective, multicenter, pivotal clinical trial of DBS in early-stage PD (IDEG050016).
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that DBS implanted in early-stage PD decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.",2020,"RESULTS


Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","['Subjects who completed the two-year trial participated in this observational follow-up study which included annual outpatient visits through five years', ""Early-Stage Parkinson's Disease"", '28 subjects who were taking PD medications six months-four years at enrollment', ""early-stage Parkinson's disease (PD""]","['subthalmic nucleus (STN) deep brain stimulation (DBS', 'bilateral STN DBS plus optimal drug therapy (ODT) versus ODT']",['safety profile'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.127564,"RESULTS


Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","[{'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Hacker', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD. Mallory.Hacker@vumc.org.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Heusinkveld', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Currie', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Millan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Molinari', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Konrad', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Davis', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Cannard', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}]",Neurology,['10.1212/WNL.0000000000009946']
1307,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010']
1308,32598992,Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,,2020,,['adult patients with Fontan circulation'],['Inspiratory muscle training'],['exercise capacity and lung function'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197853', 'cui_str': 'Fontan Circuit'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0703325,,"[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Fritz', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany. Electronic address: fritz@dhm.mhn.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ewert', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Hager', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.038']
1309,32599090,The assessment of different bleaching agents' efficiency on discoloured teeth using image-processing methods.,"BACKGROUND


Although triple antibiotic paste (TAP) has been successfully used as an intracanal medicament for regenerative endodontic treatments, TAP has also been shown to cause discolouration. The aim of this study is to investigate the efficacy of different bleaching agents to bleach teeth discoloured from TAP.
METHODS


Two hundred extracted human maxillary incisors were evaluated with VITA Easyshade, and 120 teeth were prepared and discoloured by using TAP for three weeks. After colouration, 70 teeth were randomly divided into five groups: Group 1: Negative control, Group 2: Sodium perborate, Group 3: Opalescence Endo, Group 4: Endoperox, and Group 5: Biolase. The colour changes in the third and seventh days' standard images were obtained using stereomicroscopy, RGB and Lab color space transformations were applied to the images. The CIE Lab color system was used, and total color changes (ΔE) were calculated and compared among groups and over time, using analysis of variance testing.
RESULTS


At the third day, there was no difference between bleaching materials. At the seventh day, the Biolase group was superior to sodium perborate and there was no difference between other groups. A statistically significant difference was noted between the third and seventh-day measurements for all bleaching protocols. Bleaching effectiveness of all agents increased over time.
CONCLUSIONS


Teeth discoloured by using TAP may be bleached by means of the investigated protocols, and colour alteration can be increased over time. The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.",2020,"The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.","['Two hundred extracted human maxillary incisors were evaluated with VITA Easyshade, and 120 teeth', '70 teeth']","['triple antibiotic paste (TAP', 'Negative control, Group 2: Sodium perborate, Group 3: Opalescence Endo, Group 4: Endoperox, and Group 5: Biolase']","['time', 'Bleaching effectiveness']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0074750', 'cui_str': 'sodium perborate'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",200.0,0.0177564,"The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozkocak', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Endodontics, Bolu, Turkey. Electronic address: dr_ozkocak@yahoo.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Hekim', 'Affiliation': 'Tokat Gaziosmanpasa University, Faculty of Engineering and Natural Sciences, Department of Electrical Engineering, Tokat, Turkey. Electronic address: mahmuthekim@hotmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gokturk', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Endodontics, Bolu, Turkey. Electronic address: gokturk82@hotmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Adem', 'Affiliation': 'Aksaray University, Faculty of Economics and Administrative Sciences, Department of Management Informatıon Systems, Aksaray, Turkey. Electronic address: kemaladem@gmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Comert', 'Affiliation': 'Tokat Gaziosmanpasa University, Tokat Technical Sciences Vocational School, Department of Computer Technologies, Tokat, Turkey. Electronic address: onur.comert@gop.edu.tr.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101901']
1310,32599670,Muscle contractile properties of cancer patients receiving chemotherapy: Assessment of feasibility and exercise effects.,"BACKGROUND


This pilot trial explores the feasibility of measuring muscle contractile properties in patients with cancer, effects of exercise during chemotherapy on muscle contractile properties and the association between changes in contractile muscle properties and perceived fatigue.
METHOD


Patients who received (neo)adjuvant chemotherapy for breast or colon cancer were randomized to a 9-12 week exercise intervention or a waitlist-control group. At baseline and follow-up, we measured knee extensor strength using maximal voluntary contraction (MVC), contractile muscle properties of the quadriceps muscle using electrical stimulation, and perceived fatigue using the Multidimensional Fatigue Inventory. Feasibility was assessed by the proportion of patients who successfully completed measurements of contractile muscle properties. Exercise effects on muscle contractile properties were explored using linear regression analyses. Between-group differences >10% were considered potentially relevant. Pearson correlation (r p  ) of changes in contractile muscle properties and changes in perceived fatigue was calculated.
RESULTS


Twenty two of 30 patients completed baseline and follow-up assessments. Measurements of contractile properties were feasible except for muscle fatigability. We found a potentially relevant between-group difference in the rate of force development favoring the intervention group (1192 N/s, 95% CI = -335; 2739). Change in rate of force development was negatively correlated with change in perceived general (r p   = -0.54, P = .04) and physical (r p   = -0.59, P = .02) fatigue.
CONCLUSION


Chemotherapy induces a decrease in the rate of force development, which may reflect a larger loss in type II muscle fibers. This may be attenuated with (resistance) exercise. The increase in the rate of force development was related to a decrease in perceived fatigue.",2020,"Change in rate of force development was negatively correlated with change in perceived general (r p  =-0.54, p=0.04) and physical (r p  =-0.59, p=0.02) fatigue).
","['cancer patients receiving', 'Patients who received (neo)adjuvant chemotherapy for breast or colon cancer', 'patients with cancer']","['chemotherapy', 'Chemotherapy', 'exercise intervention or a waitlist-control group']","['perceived fatigue', 'rate of force development', 'knee extensor strength using maximal voluntary contraction (MVC), contractile muscle properties of the quadriceps muscle using electrical stimulation, and perceived fatigue using the Multidimensional Fatigue Inventory', 'muscle contractile properties']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0231493', 'cui_str': 'Muscle property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0475002,"Change in rate of force development was negatively correlated with change in perceived general (r p  =-0.54, p=0.04) and physical (r p  =-0.59, p=0.02) fatigue).
","[{'ForeName': 'Laurien M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': 'Department of Physiology, Radboudumc, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Maike G', 'Initials': 'MG', 'LastName': 'Sweegers', 'Affiliation': 'Department of Epidemiology and Biostatistics and Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cornelis J', 'Initials': 'CJ', 'LastName': 'de Ruijter', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Inge R', 'Initials': 'IR', 'LastName': 'Konings', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, The Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Mai J', 'Initials': 'MJ', 'LastName': 'Chinapaw', 'Affiliation': 'Department of Public and Occupational Health and Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Teatske M', 'Initials': 'TM', 'LastName': 'Altenburg', 'Affiliation': 'Department of Public and Occupational Health and Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13758']
1311,32608179,'Virtual experience' as an intervention before a positron emission tomography/CT scan may ease patients' anxiety and improve image quality.,"INTRODUCTION


The aim of our study was to investigate the effect of a 'virtual experience' on reducing people's anxiety levels and improving image quality.
METHODS


This study included 200 people who underwent  18  F-FDG PET/CT scan for the first time. Healthy people (n = 100) and patients (n = 100) were randomly divided into a control group and an intervention group. In the intervention group, we used a 'virtual experience' as an intervention before the scan. We used the Spielberger State-Trait Anxiety Inventory (STAI) and satisfaction questionnaires for evaluation. Additionally, the image quality was analysed.
RESULTS


In the control group, more patients presented anxiety than healthy people (26(52%) versus 15(30%)) (P = 0.041). However, when the 'virtual experience' was provided, the number of cases of anxiety in the patient group decreased to 19(38%). Furthermore, patients in the intervention group had lower STAI-related scores than those in the control group (STAI-S: 37.08 ± 9.42 versus 43.34 ± 10.49, P = 0.109; STAI-T: 36.24 ± 9.55 versus 40.72 ± 9.00, P = 0.019). With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images.
CONCLUSION


A 'virtual experience' provided by an audio-visual installation can ease patients' anxiety and improve image quality.",2020,"With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images.
","['200 people who underwent  18  F-FDG PET/CT scan for the first time', 'Healthy people (n\xa0=\xa0100) and patients (n\xa0=\xa0100']","['virtual experience', 'positron emission tomography/CT scan']","[""people's anxiety levels"", 'lower STAI-related scores', 'Spielberger State-Trait Anxiety Inventory (STAI) and satisfaction questionnaires', 'number of cases of anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0376366,"With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images.
","[{'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yingjian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of medical imaging and radiation oncology,['10.1111/1754-9485.13078']
1312,32599767,"Efficacy of an Internet-Based Program to Promote Physical Activity and Exercise after Inpatient Rehabilitation in Persons with Multiple Sclerosis: A Randomized, Single-Blind, Controlled Study.","BACKGROUND


Multimodal rehabilitation improves fatigue and mobility in persons with multiple sclerosis (PwMS). Effects are transient and may be conserved by internet-based physical activity promotion programs.
OBJECTIVE


Evaluate the effects of internet-based physical activity and exercise promotion on fatigue, quality of life, and gait in PwMS after inpatient rehabilitation.
METHODS


PwMS (Expanded Disability Status Scale (EDSS) ≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32) were randomized into an intervention group (IG) or a control group (CG). After rehabilitation, IG received 3 months of internet-based physical activity promotion, while CG received no intervention.
PRIMARY OUTCOME


self-reported fatigue (WEIMuS).
SECONDARY OUTCOMES


quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score).
MEASUREMENTS


beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards.
RESULTS


64 of 84 PwMS were analyzed (IG: 34, CG: 30). After rehabilitation, fatigue decreased in both groups. At T2 and T3, fatigue increased again in CG but was improved in IG ( p  < 0.001). MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG. Gait improvements were more pronounced in IG at T2.
CONCLUSIONS


The study provides Class II evidence that the effects of rehabilitation on fatigue, quality of life, and gait can be maintained for 3-6 months with an internet-based physical activity and exercise promotion program.",2020,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"['Persons with Multiple Sclerosis', '≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32', 'persons with multiple sclerosis (PwMS', '64 of 84 PwMS were analyzed']","['internet-based physical activity promotion, while CG received no intervention', 'Internet-Based Program to Promote Physical Activity and Exercise', 'internet-based physical activity and exercise promotion', 'intervention group (IG) or a control group (CG', 'Multimodal rehabilitation']","['Gait improvements', 'MSIS-29', 'quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score', 'fatigue', 'fatigue, quality of life, and gait', 'beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards', 'self-reported fatigue (WEIMuS', 'PwMS (Expanded Disability Status Scale (EDSS', 'fatigue and mobility', 'fatigue, quality of life, and gait in PwMS', 'fatigue increased again in CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0582434', 'cui_str': 'Giving encouragement to exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",84.0,0.027244,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flachenecker', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Anna Karoline', 'Initials': 'AK', 'LastName': 'Bures', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Angeli', 'Initials': 'A', 'LastName': 'Gawlik', 'Affiliation': 'Department of Health & Social Psychology, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Weiland', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kuld', 'Affiliation': 'Faculty of Economics, University of Bayreuth, 95447 Bayreuth, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gusowski', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Streber', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tallner', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124544']
1313,32609001,Examining Identity Shift Effects in Virtual Reality.,"Identity shift describes how individuals commit to self-presentations made in public computer-mediated contexts. This study attempts to expand identity shift effects to virtual reality. Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments. The hypotheses and data analysis strategy were preregistered, and the study had sufficient  a priori  statistical power. The results did not support identity shift effects. Baseline extraversion predicted postmanipulation extraversion scores, thus suggesting identity stability. The discussion focuses on the empirical consistency of the identity shift effect and avenues for future research.",2020,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,[],['extraverted or introverted in pilot tested public or private virtual environments'],[],[],"[{'cui': 'C0557871', 'cui_str': 'Extrovert'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.0168884,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2020.0010']
1314,32603526,Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for Treatment of Anemia in Chronic Kidney Disease: A Placebo-Controlled Study of Pharmacokinetic and Pharmacodynamic Profiles in Hemodialysis Patients.,"Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study in patients with end-stage renal disease with anemia on hemodialysis. Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10 g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind placebo-controlled study. Two cohorts were randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2 mg/kg) or placebo 1 hour after hemodialysis on day 1 and 2 hours before dialysis on day 8. Maximum plasma concentration and area under the plasma concentration-time curve for patients receiving roxadustat were slightly more than dose proportional and elimination half-life ranged from 14.7 to 19.4 hours. Roxadustat was highly protein bound (99%) in plasma, and dialysis contributed a small fraction of the total clearance: only 4.56% and 3.04% of roxadustat recovered from the 1 and 2 mg/kg dose groups, respectively. Roxadustat induced transient elevations of endogenous erythropoietin that peaked between 7 and 14 hours after dosing and returned to baseline by 48 hours after dosing. Peak median endogenous erythropoietin levels were 96 mIU/mL and 268 mIU/mL for the 1- and 2-mg/kg doses, respectively, within physiologic range of endogenous erythropoietin responses to hypoxia at high altitude or after blood loss. No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.",2020,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","['Chronic Kidney Disease', 'Hemodialysis Patients', 'patients with end-stage renal disease with anemia on hemodialysis', 'Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10\xa0g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind']","['Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor', 'Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592', 'Placebo', 'placebo']","['Peak median endogenous erythropoietin levels', 'serious adverse events', 'transient elevations of endogenous erythropoietin', 'Maximum plasma concentration and area under the plasma concentration-time curve']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3713379', 'cui_str': 'FG-4592'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3658210', 'cui_str': 'Proline Hydroxylase Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2.0,0.0875764,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Provenzano', 'Affiliation': 'Department of Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Southeast Renal Research Institute, Chattanooga, Tennessee, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Zabaneh', 'Affiliation': 'Northwest Louisiana Nephrology Research, Shreveport, Louisiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chou', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hemmerich', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Neff', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'K-H Peony', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1648']
1315,32599641,Concurrent Exercise Interventions in Breast Cancer Survivors with Cancer-related Fatigue.,"This study compared the effects of two supervised concurrent training interventions in breast cancer survivors with cancer-related fatigue at baseline. Twenty-three female breast cancer survivors (50±8 years) were randomized to a high- (n=13) or a moderate-intensity (n=10) training program. Both interventions lasted 16 weeks and included the same resistance exercises, but the aerobic component was supervised and more intense in the former (i.e., rating of perceived exertion of 7-8 vs. 6 on a 1-10 scale for the high and moderate-intensity intervention, respectively). The primary endpoint was fatigue perception. Endpoints were assessed at baseline and after 16 weeks. The p-value for statistical significance was set at 0.004 after Bonferroni correction for multiple comparisons. The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011). Although the moderate-intensity training program did not provide such benefits in general (i.e., higher p-values for pre vs post-intervention comparisons), no significant differences were found between interventions (all p>0.004). Further research is needed to elucidate if the benefits provided by high-intensity concurrent training are superior to those elicited by moderate-intensity training in breast cancer survivors.",2020,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","['breast cancer survivors with cancer-related fatigue at baseline', 'breast cancer survivors', 'Breast Cancer Survivors with Cancer-related Fatigue', 'Twenty-three female breast cancer survivors (50±8 years']","['supervised concurrent training interventions', 'Concurrent Exercise Interventions', 'high- (n=13) or a moderate-intensity (n=10) training program']","['waist circumference', 'neutrophil-to-lymphocyte ratio', 'quality of life items', 'fatigue perception', 'lower-limb muscle strength']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",23.0,0.0278464,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","[{'ForeName': 'Itiziar', 'Initials': 'I', 'LastName': 'Pagola', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Javier S', 'Initials': 'JS', 'LastName': 'Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Lidia B', 'Initials': 'LB', 'LastName': 'Alejo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Barcelo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Montil', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Oliván', 'Affiliation': 'School of Physical Activity and Sport Sciences-INEF, Universidad Politecnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Álvarez-Bustos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Cantos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Maximiano', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hidalgo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcala de Henares, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Fiuza-Luces', 'Affiliation': '12th of October Hospital Research Institute, Physiology, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Casado', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}]",International journal of sports medicine,['10.1055/a-1147-1513']
1316,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock.,"RATIONALE


Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin levels may identify patients most likely to benefit from such therapy.
OBJECTIVES


To test the kinetic changes in renin levels and their prognostic value in CRVS patients.
METHODS


We analyzed serum samples from patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of angiotensin II or placebo and after 3 hours.
MEASUREMENTS AND MAIN RESULTS


Baseline serum renin concentration (normal range: 2.13-58.78 pg/ml) was above the upper limits of normal (ULN) in 194/255 (76%) study patients with a median renin concentration of 172.7 pg/mL (interquartile range [IQR]: 60.7-440.6 pg/mL), approximately three-fold higher than ULN. Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR: 37.9%-66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR: 37.6% reduction to 5.1% increase) with placebo (P<0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28/55 (50.9%) patients compared with 51/73 patients (69.9%) treated with placebo (unstratified hazard ratio: 0.56; 95% confidence interval: 0.35-0.88; P=0.012) (p = 0.048 for the interaction).
CONCLUSIONS


Serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'The University of Melbourne, 2281, Centre for Integrated Critical Care, Department of Medicine & Radiology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust and Faculty of Health Sciences University of Surrey, Department of Intensive Care Medicine, Guildford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Emory University, 1371, Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Atlanta, Georgia, United States.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'University of Maryland School of Medicine, 12264, Pulmonary and Critical Care, Baltimore, Maryland, United States.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'University of Minnesota System, 311816, Pulmonary, Allergy, Critical Care and Sleep Medicine, Minneapolis, Minnesota, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'University of California Los Angeles, 8783, Department of Anesthesiology and Perioperative Medicine, Division of Critical Care, Los Angeles, California, United States.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Wake Forest University School of Medicine, 12279, Department of Anesthesiology, Section on Critical Care Medicine, Winston-Salem, North Carolina, United States.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'University of California, Northern California Health System, Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, Mather, California, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Emory University Medical Center, Department of Medicine, Renal Division, Atlanta, Georgia, United States.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Department of Bioanalytics, San Diego, California, United States.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Department of Biostatistics, San Diego, California, United States.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Chief Executive Officer, San Diego, California, United States.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Chief Medical Officer, San Diego, California, United States.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""King's College London, Guy's & St Thomas Hospital, Critical Care, London, United Kingdom of Great Britain and Northern Ireland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC']
1317,32619713,Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis.,"PURPOSE


To compare three Photobiomodulation protocols to prevent/treat oral mucositis associated to radiotherapy.
METHODS


Seventy-three patients with cancer in oral cavity, oropharynx, and nasopharynx, who underwent RT with dose in facial fields equal or higher than 6000 cGy were randomized into three groups (mean RT dose = 66 cGy ±4.9). Protocols of Group 1 was 660 nm, 15 mW, 3.8 J/cm2, Group 2 660 nm, 25 mW, 6.3 J/cm2 both starting on the first day of radiotherapy, and group 3 660 nm, 15 mW, 3.8 J/cm2 for therapeutic purpose. The patients of group 1 and 2 were irradiated at 40 points daily covering non-keratinizing oral mucosa. The spot size (probe's tip surface size) was 0.040 cm2 for all groups. Oral mucositis was evaluated according to both WHO and NCI scales, and pain related to oral mucositis was scored using the VAS.
RESULTS


Patients from group 1 presented with grade II oral mucositis later than groups 2 and 3 (p < 0.001). Moreover, groups 2 and 3 also presented with a mean higher of oral mucositis grade than group 1, p < 0.001. Pain scores were lower in group 1 (p = 0.002).
CONCLUSIONS


The Photobiomodulation used in Group 1 was more effective than the protocols used in groups 2 and 3 in controlling the grade II oral mucositis intensity, and mean pain scores.",2020,"Pain scores were lower in group 1 (p = 0.002).
","['Seventy-three patients with cancer in oral cavity, oropharynx, and nasopharynx, who underwent RT with dose in facial fields equal or higher than 6000 cGy']",['Radiotherapy-induced Oral Mucositis'],"['grade II oral mucositis intensity, and mean pain scores', 'Oral mucositis', 'oral mucositis grade', 'WHO and NCI scales, and pain related to oral mucositis', 'grade II oral mucositis', 'Pain scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0556645', 'cui_str': 'cGy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",73.0,0.0145844,"Pain scores were lower in group 1 (p = 0.002).
","[{'ForeName': 'Paulo André Gonçalves', 'Initials': 'PAG', 'LastName': 'de Carvalho', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Roberta Cardim', 'Initials': 'RC', 'LastName': 'Lessa', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Dirce Maria', 'Initials': 'DM', 'LastName': 'Carraro', 'Affiliation': 'Laboratory of Genomics and Molecular Biology, International Research Center/CIPE, Brazil.'}, {'ForeName': 'Antonio Cássio', 'Initials': 'AC', 'LastName': 'Assis Pellizzon', 'Affiliation': 'Radiotherapy Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Graziella Chagas', 'Initials': 'GC', 'LastName': 'Jaguar', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Fábio A', 'Initials': 'FA', 'LastName': 'Alves', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil; Stomatology Department School of Dentistry, Sao Paulo University, Sao Paulo, Brazil. Electronic address: falves@accamargo.org.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101906']
1318,32611224,Process evaluation of the Cancer Home-Life Intervention: What can we learn from it for future intervention studies?,"BACKGROUND


The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant.
AIM


To evaluate the Cancer Home-Life Intervention for its processes of implementation, mechanisms of impact and contextual factors.
DESIGN


Process evaluation conducted alongside the randomised controlled trial, using quantitative and qualitative methods (ClinicalTrials.gov NCT02356627). The Cancer Home-Life Intervention is a tailored, occupational therapy-based programme.
SETTING/PARTICIPANTS


This study took place in participants' homes and at hospital. A total of 113 home-dwelling adults (⩾18 years) with advanced cancer who had received the Cancer Home-Life Intervention were included, together with five intervention-therapists.
RESULTS


All 113 participants (100%) received a first home visit; 32 participants (26%) received a second visit; and 4 participants (3%) received a third visit. Median number of delivered intervention components were 3 (interquartile range: 2; 4). Identified barriers for effect included unclear decision process for intervention dosage; participants' low expectations; participants' lack of energy; and insufficient time to adopt new strategies. The trial design constituted a barrier as the intervention could only be provided within a specific short period of time and not when relevant. Intervention components working to solve practical everyday problems, enhance enjoyment and increase a sense of safety were perceived as useful.
CONCLUSION


Future interventions can benefit from inclusion criteria closely related to the intervention focus and clear procedures for when to continue, follow-up and terminate intervention. Decisions about dose and timing may benefit from learning theory by taking into account the time and practice needed to acquire new skills.",2020,"BACKGROUND


The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant.
","[""participants' homes and at hospital"", '113 home-dwelling adults (⩾18\u2009years) with advanced cancer who had received the Cancer Home-Life Intervention were included, together with five intervention-therapists']",['Cancer Home-Life Intervention'],['Median number of delivered intervention components'],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",113.0,0.0682798,"BACKGROUND


The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant.
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'la Cour', 'Affiliation': 'REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Nyborg, Denmark.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gregersen Oestergaard', 'Affiliation': 'DEFACTUM, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Brandt', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sara Marie Hebsgaard', 'Initials': 'SMH', 'LastName': 'Offersen', 'Affiliation': 'Research Unit for General Practice, Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lindahl-Jacobsen', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Cutchin', 'Affiliation': 'Department of Health Care Sciences, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Marc Sampedro', 'Initials': 'MS', 'LastName': 'Pilegaard', 'Affiliation': 'REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Nyborg, Denmark.'}]",Palliative medicine,['10.1177/0269216320939227']
1319,32611242,Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study.,"OBJECTIVE


Plant stanol ester supplementation (2-3 g plant stanols/d) reduces plasma LDL (low-density lipoprotein) cholesterol concentration by 9% to 12% and is, therefore, recommended as part of prevention and treatment of atherosclerotic cardiovascular disease. In addition to plasma LDL-cholesterol concentration, also qualitative properties of LDL particles can influence atherogenesis. However, the effect of plant stanol ester consumption on the proatherogenic properties of LDL has not been studied. Approach and Results: Study subjects (n=90) were randomized to consume either a plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters for 6 months. Blood samples were taken at baseline and after the intervention. The aggregation susceptibility of LDL particles was analyzed by inducing aggregation of isolated LDL and following aggregate formation. LDL lipidome was determined by mass spectrometry. Binding of serum lipoproteins to proteoglycans was measured using a microtiter well-based assay. LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001. Plant stanol ester-induced decrease in LDL aggregation was more extensive in participants having body mass index<25 kg/m 2 . Decreased LDL aggregation susceptibility was associated with decreased proportion of LDL-sphingomyelins and increased proportion of LDL-triacylglycerols. LDL binding to proteoglycans was decreased in the plant stanol ester group, the decrease depending on decreased serum LDL-cholesterol concentration.
CONCLUSIONS


Consumption of plant stanol esters decreases the aggregation susceptibility of LDL particles by modifying LDL lipidome. The resulting improvement of LDL quality may be beneficial for cardiovascular health. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01315964.",2020,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","['participants having body mass', 'Study subjects (n=90']","['plant stanol ester consumption', 'Plant stanol ester', 'Plant stanol ester supplementation', 'plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters', 'plant stanol esters', 'plant stanol ester', 'Plant Stanol Esters']","['plasma LDL (low-density lipoprotein) cholesterol concentration', 'LDL aggregation susceptibility', 'LDL aggregation', 'LDL binding to proteoglycans', 'Decreased LDL aggregation susceptibility', 'serum LDL-cholesterol concentration', 'LDL quality', 'proportion of LDL-triacylglycerols', 'aggregation susceptibility of LDL particles', 'median aggregate size']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872973', 'cui_str': 'plant stanol ester'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0033692', 'cui_str': 'Proteoglycan'}, {'cui': 'C0853085', 'cui_str': 'Low density lipoprotein decreased'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0065191', 'cui_str': 'Low density lipoprotein triglyceride'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",90.0,0.0510065,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Ruuth', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Äikäs', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Feven', 'Initials': 'F', 'LastName': 'Tigistu-Sahle', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Käkelä', 'Affiliation': 'Molecular and Integrative Biosciences Research Programme, Faculty of Biological and Environmental Sciences (F.T.-S., R.K., K.Ö.), University of Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Lindholm', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland (H.L.).'}, {'ForeName': 'Piia', 'Initials': 'P', 'LastName': 'Simonen', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Petri T', 'Initials': 'PT', 'LastName': 'Kovanen', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gylling', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Öörni', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314329']
1320,32619715,Outcome of photodynamic therapy on orthodontic leveling and alignment of mandibular anterior segment: A controlled clinical trial.,"BACKGROUND


Photodynamic therapy (PDT) is a non-invasive approach that has drawn attention to accelerate orthodontic tooth movement (OTM). However, no studies have been published that evaluates the outcome of PDT on orthodontic leveling and alignment. Therefore, the present study aimed to evaluate outcome of PDT on orthodontic leveling and alignment of mandibular anterior segment.
MATERIALS AND METHODS


Thirty patients (18 females and 12 males) were included who had moderate mandibular crowding with average age was 19.23 ± 3.1 years. They were randomly divided into a control group without PDT intervention and a laser group. All patients followed non-extraction approach using one category of fixed appliance and matching NiTi archwire sequence for 3 months. In PDT group, methylene blue mediated gallium aluminum arsenide laser was applied with 635 nm, 6.5 J/cm 2 , for 10 s at 10 points (0.2 J/point) started immediately after first wire then at days 3,7,14 of first month and repeated for additional 2 months. Relief of crowding was assessed by Little`s irregularity index (LII) scores after 4, 8, and 12 weeks through scanned 3-dimensional models via a software.
RESULTS


Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05). Moreover, the alignment`s rate showed no significant differences between groups.
CONCLUSION


PDT produced a negligible effect concerning alignment of crowded mandibular anterior teeth. Besides, OTM's rate at different observation intervals showed an equivalent pattern either with or without PDT.",2020,Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05).,['Thirty patients (18 females and 12 males) were included who had moderate mandibular crowding with average age was 19.23\u2009±\u20093.1 years'],"['Photodynamic therapy (PDT', 'methylene blue mediated gallium aluminum arsenide laser', 'photodynamic therapy', 'PDT', 'control group without PDT intervention and a laser group']","[""OTM's rate"", 'LII scores', 'orthodontic leveling and alignment of mandibular anterior segment', 'Little`s irregularity index (LII) scores', 'mandibular crowding']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C1269095', 'cui_str': 'Gallium aluminum arsenide semiconductor laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}]",,0.0382065,Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05).,"[{'ForeName': 'Tharwat Osman', 'Initials': 'TO', 'LastName': 'El Shehawy', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Farouk Ahmed', 'Initials': 'FA', 'LastName': 'Hussein', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt. Electronic address: dr.farokahmed@azhar.edu.eg.'}, {'ForeName': 'Akram Abbbas', 'Initials': 'AA', 'LastName': 'Ei Awady', 'Affiliation': 'Department of Oral Medicine & Diagnosis &Radiology, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101903']
1321,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1322,32621543,Pharmacokinetics of the Monoclonal Antibody MHAA4549A Administered in Combination With Oseltamivir in Patients Hospitalized With Severe Influenza A Infection.,"MHAA4549A is a human anti-influenza A monoclonal antibody developed to treat influenza A. We report MHAA4549A serum, nasopharyngeal, and tracheal aspirate pharmacokinetics from a phase 2b study in hospitalized patients with severe influenza A. Patients were randomized 1:1:1 into 3 groups receiving single intravenous doses of 3600 mg (n = 55) or 8400 mg (n = 47) MHAA4549A or placebo (n = 56). Patients also received oral oseltamivir twice daily for ≥5 days. Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples were collected on days 1-60 from MHAA4549A-treated groups. Day 5 plasma samples from all groups were collected for assessing the pharmacokinetics of oseltamivir and its active metabolite, oseltamivir carboxylate. Noncompartmental pharmacokinetic analysis was performed using Phoenix WinNonlin. Data were collected during a preplanned interim analysis that became final when the trial terminated because of a lack of efficacy. Serum MHAA4549A concentrations were dose-proportional and biphasic. Mean MHAA4549A clearance was 288-350 mL/day, and mean half-life was 17.8-19.0 days. Nasopharyngeal MHAA4549A concentrations were non-dose-proportional. We detected MHAA4549A in tracheal aspirate samples, but intersubject variability was high. MHAA4549A serum and nasopharyngeal exposures were confirmed in all MHAA4549A-treated patients. Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects. MHAA4549A detection in tracheal aspirate samples indicated exposure in the lower respiratory tract. Oseltamivir and oseltamivir carboxylate exposures were similar between MHAA4549A-treated and placebo groups, suggesting a lack of MHAA4549A interference with oseltamivir pharmacokinetics.",2020,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"['Patients Hospitalized With Severe Influenza A Infection', 'hospitalized patients with severe influenza A. Patients']","['MHAA4549A-treated and placebo', 'oral oseltamivir', 'Monoclonal Antibody MHAA4549A', 'MHAA4549A', 'MHAA4549A or placebo']","['Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples', 'MHAA4549A serum and nasopharyngeal exposures', 'Serum MHAA4549A concentrations', 'Mean MHAA4549A clearance', 'Nasopharyngeal MHAA4549A concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C2919642', 'cui_str': 'Specimen from trachea obtained by aspiration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.04558,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Gaohong', 'Initials': 'G', 'LastName': 'She', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Hanley', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1652']
1323,32621885,Low-Molecular-Weight Heparin vs Warfarin for Thromboprophylaxis in Children With Coronary Artery Aneurysms After Kawasaki Disease: A Pragmatic Registry Trial.,"BACKGROUND


The substantial risk of thrombosis in large coronary artery aneurysms (CAAs) (maximum z-score ≥ 10) after Kawasaki disease (KD) mandates effective thromboprophylaxis. We sought to determine the effectiveness of anticoagulation (low-molecular-weight heparin [LMWH] or warfarin) for thromboprophylaxis in large CAAs.
METHODS


Data from 383 patients enrolled in the International KD Registry (IKDR) were used. Time-to-event analysis was used to account for differences in treatment duration and follow-up.
RESULTS


From diagnosis onward (96% received acetylsalicylic acid concomitantly), 114 patients received LMWH (median duration 6.2 months, interquartile range [IQR] 2.5-12.7), 80 warfarin (median duration 2.2 years, IQR 0.9-7.1), and 189 no anticoagulation. Cumulative incidence of coronary artery thrombosis with LMWH was 5.7 ± 3.0%, with warfarin 6.7 ± 3.7%, and with no anticoagulation 20.6 ± 3.0% (P < 0.001) at 2.5 years after the start of thromboprophylaxis (LMWH vs warfarin HR 1.5, 95% confidence interval [CI] 0.4-5.1; P = 0.56). A total of 51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24 warfarin. There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19). Severe bleeding complications were generally rare (1.6 events per 100 patient-years) and were noted equally for patients on LMWH and warfarin (HR 2.3, 95% CI 0.6-8.9; P = 0.25).
CONCLUSIONS


LMWH and warfarin appear to have equivalent effectiveness for preventing thrombosis in large CAAs after KD, although event rates for secondary thromboprophylaxis and safety outcomes were low. Based on our findings, all patients with CAA z-score ≥ 10 should receive anticoagulation, but the choice of agent might be informed by secondary risk factors and patient preferences.",2020,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","['51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24', 'Children with Coronary Artery Aneurysms', 'Data from 383 patients enrolled in the International KD Registry (IKDR) were used']","['LMWH', 'acetylsalicylic acid', 'warfarin', 'anticoagulation (low-molecular-weight heparin [LMWH] or warfarin', 'LMWH and warfarin', 'Low-Molecular-Weight Heparin vs Warfarin']","['Cumulative incidence of coronary artery thrombosis', 'Severe bleeding complications', 'incidence of further coronary artery thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",383.0,0.190654,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Tisiana', 'Initials': 'T', 'LastName': 'Low', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagib', 'Initials': 'N', 'LastName': 'Dahdah', 'Affiliation': 'Division of Pediatric Cardiology, Centre Hospitalier Universitaire Ste-Justine, University of Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Raghuveer', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Therese M', 'Initials': 'TM', 'LastName': 'Giglia', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dallaire', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Mathew', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Runeckles', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Harahsheh', 'Affiliation': ""Pediatrics-Cardiology, Children's National Health System/George Washington University, Washington, District of Columbia, USA.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': 'Department of Paediatrics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Friedman', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kutty', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Mondal', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada. Electronic address: brian.mccrindle@sickkids.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.016']
1324,32627812,Systemic arterial hypertension and cognition in adults: effects on executive functioning.,"BACKGROUND


Central nervous system changes associated to systemic arterial hypertension (SAH) are progressive and may cause negative effects on cognitive performance. The objective of this study was to investigate the relation between SAH and the components of executive functions (EF), inhibitory control (IC), updating and shifting, comparing a control group (without SAH) to patients with SAH, in two levels of severity.
METHODS


The protocol included the following tests to evaluate EF components: T.O.V.A. Test (IC), Backward Digit Span from Wechsler Adults Intelligence Scale (WAIS-III), Phonemic and Semantic Verbal Fluency (updating), and Trail Making Test Part B (shifting).
RESULTS


A total of 204 participants was included: 56 from the Control Group (CG), 87 SAH stage 1, and 61 SAH stage 2. The groups were not different for age (52.37±12.29) and education (10.98±4.06). As to controlled blood pressure (BP), duration of hypertension treatment and number of drugs, the SAH 2 group had a worse BP control, longer duration of hypertension treatment and use of more drugs when compared to the SAH 1. The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
CONCLUSION


The results suggest that patients with SAH have a significant impairment in EF, more specifically in updating and shifting. Besides that, such damage may be directly proportional to the severity of SAH. It is suggested that future studies include neuroimaging exams to exclude possible cerebrovascular diseases.",2020,"The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
","['patients with SAH, in two levels of severity', 'patients with SAH', 'adults', '204 participants was included: 56 from the Control Group (CG), 87 SAH stage 1, and 61 SAH stage 2']",[],"['Test (IC), Backward Digit Span from Wechsler Adults Intelligence Scale (WAIS-III), Phonemic and Semantic Verbal Fluency (updating), and Trail Making Test Part B (shifting', 'controlled blood pressure (BP), duration of hypertension treatment and number of drugs', 'executive functions (EF), inhibitory control (IC), updating and shifting', 'performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B', 'Systemic arterial hypertension and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]",[],"[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0204456', 'cui_str': 'Wechsler adult intelligence scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",204.0,0.0402133,"The findings revealed that patients with more severe hypertension presented worse performance in updating (Backward Digit Span, phonemic and semantics VF) and shifting (Trail Making Test Part B).
","[{'ForeName': 'Natália Cristina', 'Initials': 'NC', 'LastName': 'Moraes', 'Affiliation': 'Department of Neurology, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Henrique Cotchi Simbo', 'Initials': 'HCS', 'LastName': 'Muela', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universidade Agostinho Neto, Luanda, Angola.'}, {'ForeName': 'Claudia Maia', 'Initials': 'CM', 'LastName': 'MemÓria', 'Affiliation': 'Department of Neurology, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Valéria Aparecida da', 'Initials': 'VAD', 'LastName': 'Costa-Hong', 'Affiliation': 'Heart Institute, Hypertension Unit, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Michel Ferreira', 'Initials': 'MF', 'LastName': 'Machado', 'Affiliation': 'Heart Institute, Hypertension Unit, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mario Amore', 'Initials': 'MA', 'LastName': 'Cechinhi', 'Affiliation': 'Department of Neurology, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Nitrini', 'Affiliation': 'Department of Neurology, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Aparecido', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Heart Institute, Hypertension Unit, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Monica Sanches', 'Initials': 'MS', 'LastName': 'Yassuda', 'Affiliation': 'Department of Neurology, Universidade de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282x20200039']
1325,32629295,Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II).,"BACKGROUND


A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.
STUDY DESIGN AND OBJECTIVES


REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.
CONCLUSIONS


REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.",2020,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"['608 HF patients age', 'Patients with Heart Failure II', 'heart failure', 'patients with heart failure (HF) and left ventricular ejection fraction (LVEF', 'patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40']","['novel transcatheter InterAtrial Shunt Device (IASD', 'LVEF', 'supine ergometer exercise, and PCWP ≥5', 'Transcatheter InterAtrial Shunt Device', 'IASD']","['HF hospitalizations or healthcare facility visits', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'pulmonary capillary wedge pressure (PCWP', 'Elevated Left Atrial Pressure', 'hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428877', 'cui_str': 'Atrial pressure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C4544192', 'cui_str': 'Interatrial shunt'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",608.0,0.173581,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Berry', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'Corvia Medical, Tewksbury, MA.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Massaro', 'Affiliation': 'Boston University, Boston, MA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: sanjiv.shah@northwestern.edu.'}]",American heart journal,['10.1016/j.ahj.2019.10.015']
1326,32604401,Using prefrontal transcranial direct current stimulation (tDCS) to enhance proactive cognitive control in schizophrenia.,"The goal of this study was to use transcranial direct current stimulation (tDCS) to examine the role of the prefrontal cortex (PFC) in neural oscillatory activity associated with proactive cognitive control in schizophrenia. To do so, we tested the impact of PFC-targeted tDCS on behavioral and electrophysiological markers of proactive cognitive control engagement in individuals with schizophrenia. Using a within-participants, double-blinded, sham-controlled crossover design, we recorded EEG while participants with schizophrenia completed a proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20 min of active prefrontal stimulation at 2 mA or sham stimulation. We hypothesized that active stimulation would enhance proactive cognitive control, leading to changes in behavioral performance on the DPX task and in activity in the gamma frequency band during key periods of the task designed to tax proactive cognitive control. The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control. These findings, considered alongside our previous work in healthy adults, provides novel support for the role gamma oscillations in proactive cognitive control and they suggest that frontal tDCS may be a promising approach to enhance proactive cognitive control in schizophrenia.",2020,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","['healthy adults', 'schizophrenia', 'individuals with schizophrenia', 'participants with schizophrenia completed a']","['transcranial direct current stimulation (tDCS', 'proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20\u2009min of active prefrontal stimulation at 2\u2009mA or sham stimulation', 'PFC-targeted tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['pattern of error rates and increases in EEG gamma power'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0402734,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Boudewyn', 'Affiliation': 'University of California, Santa Cruz, CA, USA. mboudewyn@ucsc.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scangos', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Charan', 'Initials': 'C', 'LastName': 'Ranganath', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'University of California, Davis, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0750-8']
1327,31825020,Three-Month Effect of Silver Diamine Fluoride (SDF) in Salivary Levels of Streptococcus Mutans in Children. An Exploratory Trial.,"PURPOSE


The aim of this exploratory trial was to compare the 3-month effect of two antimicrobials on the salivary levels of Streptococcus mutans (SM) in children.
MATERIALS AND METHODS


Ninety school children aged 6-10 years participated. They were divided into two groups according to treatment used: 1% chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF). Saliva for SM colony forming unit (CFU)/ml counting was harvested in four periods: baseline (prior to antimicrobials); P1 (24 h after antimicrobial therapy); P30 (30 days after antimicrobial therapy); and P90 (90 days after antimicrobial therapy). CFU/ml data was submitted to repeated measures by analysis of variance (ANOVA).
RESULTS


Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline. No influence of antimicrobials or interactions of factors were detected (p >0.05). P30 presented the lowest levels of SM and at P90, SM levels were similar to P1 but still lower than the baseline observations. SDF and CHX presented a similar effect on SM within each period of evaluation (p = 0.65).
CONCLUSION


It was concluded that 30% SDF presents similar antimicrobial effects as 1% CHX over time. SDF might be used as an adjunctive therapy for controlling dental caries in children.",2020,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","['Ninety school children aged 6-10 years participated', 'Salivary Levels of Streptococcus Mutans in Children', 'children']","['Silver Diamine Fluoride (SDF', 'chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF']","['lowest levels of SM and at P90, SM levels', 'antimicrobial effects', 'salivary levels of Streptococcus mutans (SM']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",90.0,0.0577897,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","[{'ForeName': 'Marta Diogo', 'Initials': 'MD', 'LastName': 'Garrastazu', 'Affiliation': ''}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': ''}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Rocha', 'Affiliation': ''}, {'ForeName': 'Michele Baffi', 'Initials': 'MB', 'LastName': 'Diniz', 'Affiliation': ''}, {'ForeName': 'Taciana Marco Ferraz', 'Initials': 'TMF', 'LastName': 'Caneppele', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43360']
1328,32609979,Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children.,"BACKGROUND


Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking.
METHODS


We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age). Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia were randomly assigned to receive amoxicillin twice daily for either 3 days or 5 days. Children were followed for 14 days. The primary outcome was treatment failure by day 6; noninferiority of the 3-day regimen to the 5-day regimen would be shown if the percentage of children with treatment failure in the 3-day group was no more than 1.5 times that in the 5-day group. Prespecified secondary analyses included assessment of treatment failure or relapse by day 14.
RESULTS


From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], -0.9 to 2.4) - a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, -0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
CONCLUSIONS


In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02678195.).",2020,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
","['1497 children', 'children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age', 'Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia', 'Malawian Children', '3000 children underwent randomization', 'children with pneumonia in low-resource settings in Africa']","['amoxicillin', 'antibiotic agents', 'Amoxicillin']","['percentage of children with treatment failure', 'assessment of treatment failure or relapse by day 14', 'percentage of children with serious adverse events', 'treatment failure by day 6 or relapse']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3000.0,0.259317,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
","[{'ForeName': 'Amy-Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Chifundo B', 'Initials': 'CB', 'LastName': 'Ndamala', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}]",The New England journal of medicine,['10.1056/NEJMoa1912400']
1329,32609980,Randomized Trial of Amoxicillin for Pneumonia in Pakistan.,"BACKGROUND


The World Health Organization (WHO) recommends oral amoxicillin for patients who have pneumonia with tachypnea, yet trial data indicate that not using amoxicillin to treat this condition may be noninferior to using amoxicillin.
METHODS


We conducted a double-blind, randomized, placebo-controlled noninferiority trial involving children at primary health care centers in low-income communities in Karachi, Pakistan. Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea were randomly assigned to a 3-day course of a suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo (the test regimen), according to WHO weight bands (500 mg every 12 hours for a weight of 4 to <10 kg, 1000 mg every 12 hours for a weight of 10 to <14 kg, or 1500 mg every 12 hours for a weight of 14 to <20 kg). The primary outcome was treatment failure during the 3-day course of amoxicillin or placebo. The prespecified noninferiority margin was 1.75 percentage points.
RESULTS


From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the amoxicillin group). In the per-protocol analysis, the incidence of treatment failure was 4.9% among placebo recipients (95 of 1927 children) and 2.6% among amoxicillin recipients (51 of 1929 children) (between-group difference, 2.3 percentage points; 95% confidence interval [CI], 0.9 to 3.7). Results were similar in the intention-to-treat analysis. The presence of fever and wheeze predicted treatment failure. The number needed to treat to prevent one treatment failure was 44 (95% CI, 31 to 80). One patient (<0.1%) in each group died. Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
CONCLUSIONS


Among children younger than 5 years of age with nonsevere pneumonia, the frequency of treatment failure was higher in the placebo group than in the amoxicillin group, a difference that did not meet the noninferiority margin for placebo. (Funded by the Joint Global Health Trials Scheme [of the Department for International Development, Medical Research Council, and Wellcome] and others; RETAPP ClinicalTrials.gov number, NCT02372461.).",2020,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
","['patients who have pneumonia with tachypnea', 'Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea', 'children at primary health care centers in low-income communities in Karachi, Pakistan', 'Pneumonia in Pakistan', 'children younger than 5 years of age with nonsevere pneumonia', 'From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the']","['amoxicillin', 'suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo', 'Amoxicillin', 'placebo']","['Relapse', 'number needed to treat to prevent one treatment failure', 'treatment failure during the 3-day course of amoxicillin or placebo', 'incidence of treatment failure', 'frequency of treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",4002.0,0.735183,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.
","[{'ForeName': 'Fyezah', 'Initials': 'F', 'LastName': 'Jehan', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Nisar', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Kerai', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Balouch', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Najeeb', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Shafiq', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911998']
1330,32615237,Influence of different clinical criteria on the decision to replace restorations in primary teeth.,"OBJECTIVES


This cross-sectional study is nested in a randomized clinical trial. It was designed to evaluate the influence of using two different clinical criteria to assess caries lesion around restorations on the decision to replace restorations in primary posterior teeth. Variables that might influence this decision were also considered.
METHODS


One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old). Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria. After reaching the treatment decision, the same examiner performed another evaluation using the other criteria. Spearman's correlation coefficients and 95 % confidence intervals (95 %CI) between the scores obtained with both criteria and respective treatment decisions were calculated. Poisson multilevel regression analysis were performed between the exploratory variables related to children, restored tooth and restoration assessment; the outcome variables were decisions related to restoration replacement, any operative intervention and presence of secondary caries.
RESULTS


The strongest correlation observed between the methods was for recurrence of caries. A total of 94 restorations (17.1 %) were indicated for replacement with FDI criteria and 30 (5.5 %) were indicated for replacement with CARS. Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
CONCLUSIONS


The decision to replace posterior restorations in primary teeth is influenced by the criteria used for the restorations assessment and also by the children's caries experience and multisurface restorations. The restoration material did not influence the decision of restorations replacement.
CLINICAL SIGNIFICANCE


The decision to replace posterior restoration in primary teeth is strongly related to the evaluation method and not only by patients' risk factors.",2020,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
","['One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old', 'Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria', 'primary posterior teeth', 'primary teeth']",[],"['operative intervention and presence of secondary caries', 'recurrence of caries']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",160.0,0.0402393,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions.
","[{'ForeName': 'Bruna Lorena Pereira', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: bruna.moro@usp.br.'}, {'ForeName': 'Raiza Dias', 'Initials': 'RD', 'LastName': 'Freitas', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: raizafreitas@usp.br.'}, {'ForeName': 'Laura Regina Antunes', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: laura.pontes@usp.br.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Pássaro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: ana.passaro@usp.br.'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: tathiane.lenzi@ufrgs.br.'}, {'ForeName': 'Tamara Kerber', 'Initials': 'TK', 'LastName': 'Tedesco', 'Affiliation': 'Graduation Program in Dentistry, Ibirapuera University, São Paulo, Brazil. Electronic address: tamarakt@usp.br.'}, {'ForeName': 'Kim Rud', 'Initials': 'KR', 'LastName': 'Ekstrand', 'Affiliation': 'Section of Cariology and Endodontics, University of Copenhagen, Copenhagen, Denmark. Electronic address: kek@sund.ku.dk.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: mmbraga@usp.br.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Federal University of Pelotas, Graduate Program in Dentistry, Pelotas, Rio Grande do Sul, Brazil. Electronic address: maximiliano.cenci@ufpel.edu.br.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: fmmendes@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103421']
1331,32618875,Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? A randomised controlled trial.,"Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at 3 centres in the United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at 6-month follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG = 54, NTG = 51). Mean numerical rating scale pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6 months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% confidence interval [CI]: -1.2 to 0.9, P = 0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.",2020,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"['Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51', 'patients with chronic pain of neuropathic origin']","['SCS screening trial strategy (TG) or no trial screening strategy (NTG', 'Spinal cord stimulation (SCS', 'TG and NTG']","['mean incremental cost-effectiveness ratio of TG', 'numerical rating scale (NRS) pain', 'Mean NRS pain']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",105.0,0.379353,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Rui V', 'Initials': 'RV', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gulve', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Anaesthesia, Basildon and Thurrock University Hospitals, Basildon, United Kingdom.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Baranidharan', 'Affiliation': 'Leeds Neuromodulation Centre, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Houten', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Chadwick', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Earle', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001977']
1332,32622074,Application of photodynamic therapy against periodontal bacteria in established gingivitis lesions in adolescent patients undergoing fixed orthodontic treatment.,"BACKGROUND


The aim of this 4 week follow up randomized controlled clinical trial is to evaluate the effectiveness of photodynamic therapy (PDT) as an adjunct to ultrasonic scaling (US) in the reduction of gingival inflammatory parameters and periodontal pathogens in established gingival inflammation in adolescent patients undergoing fixed orthodontic treatment.
MATERIALS AND METHODS


A total of 22 adolescent patients (mean age: 17.5 years) undergoing fixed orthodontic treatment and presenting with persistent local gingival inflammation were randomized into two groups: Group-US: patients receiving ultrasonic scaling (US) with usual oral hygiene instructions and Group-PDT: in which patients received adjunctive PDT with US. Dichotomous recording for plaque scores (PS) and bleeding on probing (BOP) was used to assess the clinical inflammatory status. The total bacterial counts of P. gingivalis and T. forsythia were estimated and were expressed as log CFU/mL. All assessments were performed at baseline, 1 week and 4 weeks. For intergroup comparisons, student's t-test was computed along with Bonferroni correction for post hoc multiple comparisons. To identify differences between repeated follow-ups, ANOVA multiple rank test was used.
RESULTS


Both treatment modalities reported statistically significant reduction in PS and BOP in patients undergoing fixed orthodontic treatment (p < 0.05). However, there was no significant difference in PS and BOP when US was compared with PDT (p > 0.05). Group-US showed statistically significant reduction in T. forsythia at 1 week only (p < 0.05). Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05). This was also significant when compared with US on both the time points (p < 0.05).
CONCLUSION


PDT was effective in significantly reducing periodontal pathogens in established gingivitis lesions in adolescent patients undergoing fixed orthodontic treatment in short term.",2020,Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05).,"['adolescent patients undergoing fixed orthodontic treatment', '22 adolescent patients (mean age: 17.5 years) undergoing fixed orthodontic treatment and presenting with persistent local gingival inflammation', 'adolescent patients undergoing fixed orthodontic treatment in short term']","['photodynamic therapy (PDT', 'PDT', 'photodynamic therapy against periodontal bacteria', 'Group-US: patients receiving ultrasonic scaling (US) with usual oral hygiene instructions and Group-PDT', 'adjunctive PDT with US']","['P. gingivalis and T. forsythia', 'PS and BOP', 'periodontal pathogens', 'T. forsythia', 'plaque scores (PS) and bleeding on probing (BOP', 'total bacterial counts of P. gingivalis and T. forsythia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",22.0,0.027607,Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05).,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al Nazeh', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Almoammar', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Muhammad Abdullah', 'Initials': 'MA', 'LastName': 'Kamran', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Rafi A', 'Initials': 'RA', 'LastName': 'Togoo', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia. Electronic address: ishahrani@kku.edu.sa.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101904']
1333,32627570,Multi-component communication intervention for children with autism: A randomized controlled trial.,"LAY ABSTRACT


This study reports the results of a randomized trial for preverbal preschoolers with autism that demonstrates the effects of multiple intervention strategies including caregiver training. About 50% of children with autism are not talking by age 3 and up to 30% of children with autism will remain minimally verbal past age 5. Interventions delivered by clinicians and caregivers have the greatest effects on spoken language and may reduce the rate of those who remain minimally verbal. Sixty-eight children ages 3-5 with autism and their caregivers participated in this randomized trial comparing the communication intervention to a comparison group. A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention. Future research is needed to understand for whom and under what conditions this intervention is most effective.",2020,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","['children with autism', 'Sixty-eight children ages 3-5 with autism and their caregivers participated', 'preverbal preschoolers with autism']","['Multi-component communication intervention', 'multi-component, communication intervention (including a speech-generating device', 'communication intervention']",['joint attention skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.043766,"A brief, multi-component, communication intervention (including a speech-generating device) for children with autism that addresses core deficits may be effective in improving joint attention skills immediately following intervention and social communication skills 4 months following intervention.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Hampton', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Kaiser', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Fuller', 'Affiliation': 'Vanderbilt University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934558']
1334,32623425,Work-focused therapy for common mental disorders: A naturalistic study comparing an intervention group with a waitlist control group.,"BACKGROUND


Common mental disorders (CMD) are leading causes of sickness absence. Treatments for CMD that both reduce symptoms and support work participation urgently need to be developed.
OBJECTIVE


Determine the potential effects of work-focused therapy combining work interventions with either meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT) for patients with CMD on sick leave.
METHODS


Naturalistic study with a quasi-experimental approach. Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety) were compared between the intervention group (n = 87) who received immediate treatment over an average of 10.40 sessions (SD = 3.09) and the non-randomized waitlist control group (n = 95) that had waited an average of 11.18 weeks (SD = 2.29).
RESULTS


Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%). Effect sizes for self-efficacy scores, depression and anxiety were large in the intervention group (d = 1.28, 1.01, 1.58), and significantly lower in the control group (d = 0.60, 0.14, 0.45). Significantly more patients in the treatment group than control group recovered from depression (54.1% vs. 12.8%) and anxiety (50.0% vs.10.6%).
CONCLUSIONS


W-MCT/CBT may be an effective intervention for patients on sick leave due to CMD.",2020,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"['patients with CMD on sick leave', 'Naturalistic study with a quasi-experimental approach', 'common mental disorders']","['meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT', 'W-MCT/CBT']","['anxiety', 'depression', 'self-efficacy scores, depression and anxiety', 'Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0689232,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"[{'ForeName': 'Ragne G H', 'Initials': 'RGH', 'LastName': 'Gjengedal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Osnes', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Lagerfeld', 'Affiliation': 'Instituut Gak, Hilversum, The Netherlands.'}, {'ForeName': 'Roland W B', 'Initials': 'RWB', 'LastName': 'Blonk', 'Affiliation': 'Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sandin', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Torkil', 'Initials': 'T', 'LastName': 'Berge', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Odin', 'Initials': 'O', 'LastName': 'Hjemdal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}]","Work (Reading, Mass.)",['10.3233/WOR-203208']
1335,32624182,Potentiation by sevoflurane of rocuronium-induced neuromuscular block is greater in older than younger adult patients: a randomised controlled trial.,,2020,,['older than younger adult patients'],"['rocuronium-induced neuromuscular block', 'sevoflurane']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",[],,0.594978,,"[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Takagi', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kitajima', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Matsui', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Tokyo, Japan. Electronic address: suzuki.takahiro@nihon-u.ac.jp.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.047']
1336,32627071,Percutaneous electrical stimulation of the posterior tibial nerve for the treatment of fecal incontinence: manometric results after 6 months of treatment.,"BACKGROUND


Posterior tibial nerve stimulation (PTNS) is a minimally invasive approach with little adverse effects, but obtaining good results as shown in the different scales for the evaluation of the severity of incontinence. The aim of this study was to determine the effects of PTNS based on manometric determinations of the anal sphincter and severity during a period of treatment of 6 months (18 sessions).
PATIENTS AND METHODS


A prospective interventional study of patients with fecal incontinence was performed. Subjects underwent one 30-min session every week for 12 weeks, followed by 6 sessions every 2 weeks. The effect on incontinence was evaluated by means of St. Marks and defecatory urgency scales, and manometry.
RESULTS


Seventy-three patients were included. At baseline, 28.8% of the patients had a retention time of less than 1 min. At 12 weeks, 39.7% of the patients presented a retention time to 5-10 min and at 18 weeks 37% presented it over 10 min. At baseline, mean St Marks score was 15.1 + 5.1, improving after 12 weeks of treatment to 8.9 + 5 (p < 0.001). After 18 sessions, a greater improvement was observed up to 4 + 4.8 (p < 0.001). Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006). Similarly, maximum squeeze pressure also presented a significant augmentation (mean increase 25.3 mmHg; p = 0.002).
CONCLUSION


Eighteen sessions of PTNS, divided in 12 weekly sessions and 6 sessions every 2 weeks, have shown to obtain benefits, reducing the St. Marks and the defecatory urgency scores, and increasing the manometric values.",2020,Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006).,"['fecal incontinence', 'patients with fecal incontinence', 'Seventy-three patients were included']","['Percutaneous electrical stimulation', 'Posterior tibial nerve stimulation (PTNS', 'PTNS']","['Maximum resting pressure', 'St. Marks and defecatory urgency scales, and manometry', 'mean St Marks score', 'retention time', 'maximum squeeze pressure']","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}]",73.0,0.0330054,Maximum resting pressure showed a significant increase after treatment (mean increase 9.8 mmHg; p = 0.006).,"[{'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Manso', 'Affiliation': 'International Doctorate School, Faculty of Health Sciences, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alias', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Levano-Linares', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Laiz', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Garcia-Olmo', 'Affiliation': 'Department of Surgery, Fundacion Jimenez Diaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Duran', 'Affiliation': 'Department of Surgery, Rey Juan Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Faculty of Health Sciences, Rey Juan Carlos University, Madrid, Spain. jruiztovar@gmail.com.'}]",International journal of colorectal disease,['10.1007/s00384-020-03564-4']
1337,32623510,"Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial.","PURPOSE


To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).
METHODS


We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.
RESULTS


A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.
CONCLUSION


90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.
RETROSPECTIVELY REGISTERED


ChiCTR2000030924, 2020/3/17.",2020,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","['A total of 354 and 351 patients were included in BCQB group and in placebo group', 'persistent allergic rhinitis', 'patients with PAR', '720 patients from 15 hospitals across China and randomly assigned them into', 'patients with persistent allergic rhinitis (PAR']","['BCQB', 'VAS', 'Bencycloquidium bromide nasal spray', 'BCQB group or placebo', 'bencycloquidium bromide nasal spray (BCQB', 'placebo']","['change ratio from baseline of VAS for rhinorrhea', 'Adverse events', 'VAS for rhinorrhea', 'incidence of adverse reaction', 'Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",720.0,0.566384,"Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day.","[{'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Shixi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, 610072, People's Republic of China.""}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Southwest Hospital, Army Medical University, 30 Gaotan Yan St, Chongqing, 400038, People's Republic of China.""}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Daping Hospital, Army Medical University, Chongqing, 400042, People's Republic of China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Otolaryngology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Otolaryngology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, People's Republic of China.""}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Otorhinolaryngology, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People's Republic of China.""}, {'ForeName': 'Xuping', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Hunan Provincial People's Hospital, Changsha, 410005, People's Republic of China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': ""Department of Otolaryngology, Qingdao Municipal Hospital, Qingdao, Shandong, 266011, People's Republic of China.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Dong', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Shanghai General Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, People's Republic of China.""}, {'ForeName': 'Yongwang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, 300211, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The First People's Hospital, Yangzhou, 225001, People's Republic of China.""}, {'ForeName': 'Guolin', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology Head and Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, 410013, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Health, Statistics, Faculty of Medical Service, Second Military Medical University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Yingu Pharmaceutical Co., Ltd, Beijing, 100190, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': ""Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China. mjmelinda@163.com.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06183-5']
1338,32609532,Cardiovascular and metabolic responses to passive hypoxic conditioning in overweight and mildly obese individuals.,"Although severe intermittent hypoxia (IH) is well known to induce deleterious cardiometabolic consequences, moderate IH may induce positive effects in obese individuals. The present study aimed to evaluate the effect of two hypoxic conditioning programs on cardiovascular and metabolic health status of overweight or obese individuals. In this randomized single-blind controlled study, 35 subjects (54 ± 9.3 yr, 31.7 ± 3.5 kg/m 2 ) were randomized into three 8-wk interventions (three 1-h sessions per week): sustained hypoxia (SH), arterial oxygen saturation ([Formula: see text]) = 75%; IH, 5 min [Formula: see text] = 75% - 3 min normoxia; normoxia. Ventilation, heart rate, blood pressure, and tissue oxygenation were measured during the first and last hypoxic conditioning sessions. Vascular function, blood glucose and insulin, lipid profile, nitric oxide metabolites, and oxidative stress were evaluated before and after the interventions. Both SH and IH increased ventilation in hypoxia (+1.8 ± 2.1 and +2.3 ± 3.6 L/min, respectively;  P  < 0.05) and reduced normoxic diastolic blood pressure (-12 ± 15 and -13 ± 10 mmHg, respectively;  P  < 0.05), whereas changes in normoxic systolic blood pressure were not significant (+3 ± 9 and -6 ± 13 mmHg, respectively;  P  > 0.05). IH only reduced heart rate variability (e.g., root-mean-square difference of successive normal R-R intervals in normoxia -21 ± 35%;  P  < 0.05). Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites, or oxidative stress, except for an increase in superoxide dismutase activity following SH. This study indicates that passive hypoxic conditioning in obese individuals induces some positive cardiovascular and respiratory improvements despite no change in anthropometric data and even a reduction in heart rate variability during IH exposure.",2020,"Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress, except an increase in superoxide dismutase activity following SH.
","['overweight and mildly obese individuals', 'overweight or obese individuals', 'obese individuals', '35 subjects (54±9.3yr, 31.7±3.5kg·m -2 ']","['hypoxic conditioning programs', 'sustained hypoxia (SH), arterial oxygen saturation (SpO 2 ) =75%; IH, 5min SpO 2 =75% - 3min normoxia; normoxia', 'passive hypoxic conditioning']","['Cardiovascular and metabolic responses', 'normoxic systolic blood pressure', 'body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress', 'Ventilation, heart rate, blood pressure and tissue oxygenation', 'normoxic diastolic blood pressure', 'ventilation in hypoxia', 'cardiovascular and metabolic health status', 'superoxide dismutase activity', 'heart rate variability', 'Vascular function, blood glucose and insulin, lipid profile, nitric oxide metabolites and oxidative stress']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",35.0,0.0345242,"Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress, except an increase in superoxide dismutase activity following SH.
","[{'ForeName': 'Samarmar', 'Initials': 'S', 'LastName': 'Chacaroun', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borowik', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Belaidi', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Wuyam', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Flore', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': 'HP2 laboratory, Univiversité Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00311.2019']
1339,32610254,"Antioxidant cocktail following a high-sodium meal does not affect vascular function in young, healthy adult humans: a randomized controlled crossover trial.","Chronic high sodium intake is a risk factor for cardiovascular disease as it impairs vascular function through an increase in oxidative stress. The objective of this study was to investigate the acute effects of a high-sodium meal (HSM) and antioxidant (AO) cocktail on vascular function. We hypothesized that a HSM would impair endothelial function, and increase arterial stiffness and wave reflection, while ingestion of the AO cocktail would mitigate this response. Healthy adults ingested either an AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM (1500 mg) in a randomized crossover blinded design. Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx) were made at baseline and 30, 60, 90, and 120 min after meal consumption. Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study. Mean BP increased at 120 min relative to 60 min (60 min: 79 ± 1; 120 min: 81 ± 1 mmHg; time effect P = .01) but was not different between treatments (treatment × time interaction P = .32). AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31). PWV (treatment × time interaction, P = .91) and FMD (treatment × time interaction P = .65) were also not different between treatments. In conclusion, a HSM does not acutely impair vascular function suggesting young healthy adults can withstand the acute impact of sodium on the vasculature and therefore, the AO cocktail is not necessary to mitigate the response.",2020,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"['young healthy adults', 'young, healthy adult humans', 'Healthy adults ingested either an', 'Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study']","['Antioxidant cocktail following a high-sodium meal', 'HSM', 'AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM', 'high-sodium meal (HSM) and antioxidant (AO) cocktail']","['endothelial function', 'Mean BP', 'FMD', 'Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx', 'vascular function', 'PWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.120549,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Smiljanec', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ksmilja@udel.edu.'}, {'ForeName': 'Alexis U', 'Initials': 'AU', 'LastName': 'Mbakwe', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ambakwe@udel.edu.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Ramos-Gonzalez', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: macramos@udel.edu.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Biostatistics Core Facility, University of Delaware, STAR, Newark, DE. Electronic address: rpohlig@udel.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: slennon@udel.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.011']
1340,32610257,Oral vitamin C treatment increases polymorphonuclear cell functions in type 2 diabetes mellitus patients with poor glycemic control.,"This study investigated the effect of vitamin C on polymorphonuclear (PMN) cell functions in type 2 diabetes mellitus patients with poor glycemic control. We hypothesized that oral vitamin C treatment improves PMN cell functions. Patients (14) received either a vitamin C (1000 mg/d) or placebo (anhydrous calcium hydrogen phosphate) tablet for 6 weeks and were subjected to a 6-week washout period followed by a 6-week treatment crossover period. Blood samples were collected at pretreatment and posttreatment for PMN cell functions (by flow cytometry) and plasma vitamin C concentration. Phagocytosis was examined by incubating whole blood samples with fluorescein isothiocyanate-labeled Staphylococcus aureus, and oxidative burst was simultaneously evaluated by adding hydroethidine. In comparison with placebo, vitamin C increased both PMN cell phagocytosis (pretreatment: placebo, 17.8% ± 1.6% and vitamin C, 19.0% ± 3.4%, P = .70; posttreatment: placebo, 16.6% ± 1.7% and vitamin C, 27.1% ± 2.9%, P = .005) and oxidative burst (pretreatment: placebo, 6.4% ± 0.8% and vitamin C, 7.1% ± 1.2%, P = .60; posttreatment: placebo, 6.9% ± 1.3% and vitamin C, 12.1% ± 1.6%, P = .02). The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01). Plasma vitamin C concentration and PMN cell functions were not significantly different before both treatments. We conclude that the 6-week 1000-mg/d vitamin C increased PMN phagocytosis and oxidative burst in type 2 diabetes mellitus patients with poor glycemic control.",2020,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,['type 2 diabetes mellitus patients with poor glycemic control'],"['Oral vitamin C treatment', 'placebo, vitamin C', 'oral vitamin C', 'vitamin C', 'placebo (anhydrous calcium hydrogen phosphate) tablet', 'placebo']","['PMN cell functions', 'polymorphonuclear (PMN) cell functions', 'Plasma vitamin C concentration and PMN cell functions', 'Blood samples', 'PMN cell phagocytosis', 'oxidative burst', 'plasma vitamin C concentration', 'polymorphonuclear cell functions', 'PMN phagocytosis and oxidative burst']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0108134', 'cui_str': 'Calcium phosphate dibasic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0085416', 'cui_str': 'Oxidative Burst'}]",,0.155192,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Chuangchot', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: nisachuang@kku.ac.th.'}, {'ForeName': 'Chongchira', 'Initials': 'C', 'LastName': 'Boonthongkaew', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chongchira@kkumail.com.'}, {'ForeName': 'Wisitsak', 'Initials': 'W', 'LastName': 'Phoksawat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: wisitsakphok@kkumail.com.'}, {'ForeName': 'Amonrat', 'Initials': 'A', 'LastName': 'Jumnainsong', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: amonrat@kku.ac.th.'}, {'ForeName': 'Chanvit', 'Initials': 'C', 'LastName': 'Leelayuwat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chanvit@kku.ac.th.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Leelayuwat', 'Affiliation': 'Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: naruemon@kku.ac.th.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.010']
1341,32615357,Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.,"BACKGROUND


High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed.
METHODS


The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
CURRENT STATUS


The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018.
CONCLUSION


The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.",2020,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","['Mean age at baseline was 71\u202fyears, and 76% are male', '48 senior residential facilities with 1,606 participants', 'residents in senior residential facilities', 'older adults in China', '48 senior residential facilities in northern China']","['salt substitute and stepwise reduction of salt supply', 'salt intervention', 'stepwise salt supply control (SSSC', 'normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS']","['blood pressure', 'change in systolic blood pressure', 'blood pressure reduction', 'incidence of hyperkalemia, hyponatremia, cardiovascular events, and death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.0400665,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","[{'ForeName': 'Aoming', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Kiang', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Qianku', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lae', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.05.013']
1342,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1343,32621073,"Conscious perception and the modulatory role of dopamine: no effect of the dopamine D2 agonist cabergoline on visual masking, the attentional blink, and probabilistic discrimination.","RATIONALE


Conscious perception is thought to depend on global amplification of sensory input. In recent years, striatal dopamine has been proposed to be involved in gating information and conscious access, due to its modulatory influence on thalamocortical connectivity.
OBJECTIVES


Since much of the evidence that implicates striatal dopamine is correlational, we conducted a double-blind crossover pharmacological study in which we administered cabergoline-a dopamine D2 agonist-and placebo to 30 healthy participants. Under both conditions, we subjected participants to several well-established experimental conscious-perception paradigms, such as backward masking and the attentional blink task.
RESULTS


We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
CONCLUSIONS


Our results cast doubt on a causal role for dopamine in visual perception. It remains an open possibility that dopamine has causal effects in other tasks, perhaps where perceptual uncertainty is more prominent.",2020,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
",['30 healthy participants'],"['cabergoline-a dopamine D2 agonist-and placebo', 'dopamine D2 agonist cabergoline', 'backward masking and the attentional blink task', 'cabergoline', 'dopamine']","['visual masking, the attentional blink, and probabilistic discrimination']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",30.0,0.0541971,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Boonstra', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands. evertboonstra@gmail.com.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Seth', 'Affiliation': 'Department of Informatics Sackler Centre for Consciousness Science, University of Sussex, Brighton, BN1 9QJ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zantvoord', 'Affiliation': 'Department of Child and Adolescent Psychiatry, The Bascule, Academic Centre for Child and Adolescent Psychiatry Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Lansink', 'Affiliation': 'Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Slagter', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05579-9']
1344,32623230,"Supplemental income program design: A cluster-randomized controlled trial to examine the health and wellbeing effects on older adults by gender, duration, and payment frequency.","BACKGROUND


We documented results from a cluster-randomized controlled trial we designed to supplement incomes in poor towns among adults 70 or older. We analyzed effects on health by gender, persistence over time, and variation by payment frequency.
METHODS


We compared supplemental income effects over an 18-month period for two towns in Yucatan, Mexico: Valladolid, where eligible individuals received a monthly income supplement over the entire analysis period, and Motul, a demographically matched control town, where eligible individuals received a bimonthly income supplement over the last 12 months of the analysis period. While differing in frequency of payment, supplements provided similar levels of income. We conducted three surveys of recipients: (1) at baseline, (2) six months after baseline, and (3) 18 months after baseline.
RESULTS


The primary outcomes we examined were peak expiratory flow, hemoglobin level, and verbal recall. The secondary outcomes were health care use and food availability. We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting. Bimonthly income supplements had smaller health benefits.
CONCLUSIONS


Older people in the developing world who lack social security benefits and health care may benefit most from monthly income programs. The greater payment frequency of monthly programs may influence how household resources are allocated. Supplemental income programs are common in low- and middle-income countries; hence, our results have implications for program design in many nations.",2020,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","['supplement incomes in poor towns among adults 70 or older', 'older adults by gender, duration, and payment frequency']",[],"['health care use and food availability', 'peak expiratory flow, hemoglobin level, and verbal recall', 'smaller health benefits']","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}]",,0.190785,"We found health benefits persisted for at least eighteen months for the monthly income supplement, with both males and females benefiting.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aguila', 'Affiliation': 'Sol Price School of Public Policy, USC, 650 Childs Way, RGL Hall, Room 226, Los Angeles, CA, 90089, USA. Electronic address: eaguilav@usc.edu.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Smith', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, 90401, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113139']
1345,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1346,32624429,Effect of Prior Formal Education on Successful Thoracic Epidural Placement By Anesthesia Residents.,"OBJECTIVE


Catheter placement for thoracic epidural analgesia (TEA) is technically challenging; however, methods for teaching this technique to anesthesia residents have not been well-studied. The present study aimed to determine optimal teaching methods for proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training by attending physicians.
DESIGN


Prospective, randomized study.
SETTING


Large academic hospital, single institution.
PARTICIPANTS


The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control).
INTERVENTIONS


Formal education included an instructional video on proper TEA technique.
MEASUREMENTS AND MAIN RESULTS


Measures of proficiency in TEA catheter placement included the time needed to complete the procedure successfully and the success of placement as indicated by patient confirmation. Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents. The overall success rate was 99.2%, with faculty intervention required in only 17% of cases. More experienced residents (ie, having placed more epidural catheters) were faster at TEA catheter placement.
CONCLUSIONS


Formal video education for TEA catheter placement provided no additional improvement of resident proficiency compared with traditional training at a high-volume academic center. The success rate was very high in this group of residents; however, experiences at other institutions may vary. Future studies are needed to determine optimum teaching strategies for TEA.",2020,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"['Large academic hospital, single institution', 'The study comprised 76 postgraduate year 3 and 4 anesthesiology residents (38 intervention, 38 control', 'Successful Thoracic Epidural Placement By Anesthesia Residents']","['Prior Formal Education', 'Formal education included an instructional video on proper TEA technique', 'TEA catheter placement', 'proficient TEA catheter placement by comparing video-based formal resident education with traditional bedside training', 'Catheter placement for thoracic epidural analgesia (TEA', 'formal video instruction']","['time needed to complete the procedure successfully and the success of placement', 'success rate', 'overall success rate']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.072334,Residents who received formal video instruction had similar success in catheter placement and similar procedure times compared with the traditionally trained residents.,"[{'ForeName': 'Yar Luan', 'Initials': 'YL', 'LastName': 'Yeap', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN. Electronic address: yyeap@iupui.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Randolph', 'Affiliation': 'Anesthesia Consultants Of Indianapolis, Indianapolis, IN.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Lemmon', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Mann', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wolfe', 'Affiliation': 'Department of Anesthesia, Indiana University School of Medicine, Indianapolis, IN.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.023']
1347,32632501,The possibility of a transanal tube as an alternative to diverting stoma in terms of preventing severe postoperative anastomotic leakage after laparoscopic low anterior resection.,"PURPOSE


The purpose of this study was to reveal whether a transanal tube (TAT) could act as an alternative to a diverting stoma (DS) after laparoscopic low anterior resection.
PATIENTS AND METHODS


A total of 89 consecutive rectal cancer patients whose tumors were located within 15 cm from the anal verge who underwent laparoscopic low anterior resection without a DS at our institution between May 12, 2015 and August 31, 2019 were included. All patients received a postoperative Gastrografin enema study (GES) through a TAT between the 3rd and 10th postoperative day. We planned two study protocols. From May 12, 2015 to March 31, 2017, we conducted a second operation including a DS construction immediately when radiological anastomotic leakage (rAL) was detected (Group A, n=46). From April 1, 2017 to August 31, 2019, we continued TAT drainage even if rAL was detected and repeated the GES weekly until the rAL was healed (Group B, n=43).
RESULTS


In Group A (n=46), 14 cases of rAL were included, 11 of which underwent stoma construction. The remaining 3 patients who refused stoma construction were treated conservatively. In Group B (n=43) rAL was encountered in 10, and 7 of these patients were treated successfully by TAT continuous drainage. The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%) (p=0.028).
CONCLUSIONS


A TAT could act as a DS to mitigate the symptoms of anastomotic leakage after laparoscopic low anterior resection.",2020,The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%),"['after laparoscopic low anterior resection', '89 consecutive rectal cancer patients whose tumors were located within 15 cm from the anal verge who underwent laparoscopic low anterior resection without a DS at our institution between May 12, 2015 and August 31, 2019 were included', 'In Group A (n=46), 14 cases of rAL were included, 11 of which underwent stoma construction']","['TAT continuous drainage', 'transanal tube (TAT']","['severe postoperative anastomotic leakage', 'radiological anastomotic leakage (rAL', 'rate of DS', 'anastomotic leakage']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}]",89.0,0.0206708,The rate of DS in Group B (7.0%) was significantly lower than that in Group A (23.9%),"[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Hamada', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan. KGH03145@nifty.com.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Inada', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Surgery, Terada Hospital, Nabari, Mie, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Oishi', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Shigemitsu', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Sekimoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1, Shinmachi, Hirakata, Osaka, 573-1191, Japan.'}]",International journal of colorectal disease,['10.1007/s00384-020-03624-9']
1348,32615462,The effect of baclofen on objective and subjective sleep measures in a model of transient insomnia.,"STUDY OBJECTIVES


Insomnia is a common medical complaint. Current pharmacologic treatments have modest efficacy and numerous side effects. Baclofen is a gamma-aminobutyric acid (GABA)b receptor agonist used to treat spasticity in various medical conditions. Several studies noted that baclofen, when used to treat sleep related disorders, resulted in improvement in sleep parameters. Measures of insomnia, however, were not assessed in those studies. To date, baclofen has not been assessed for efficacy in the treatment of insomnia.
METHODS


We randomized 20 healthy subjects to baclofen or placebo in a cross over design. All subjects underwent two polysomnograms (PSG) assessing sleep parameters. Baclofen or placebo was given 90 min prior to lights out in random order for each subject. Lights out occurred two hours earlier than the subject's median habitual bedtime.
RESULTS


Baclofen resulted in significantly less objective wake after sleep onset and stage 1 sleep, and significantly increased total sleep time (TST), sleep efficiency, and stage 3/4 sleep. There was no effect on sleep onset latency (SOL). Self-report variables indicated significantly less subjective awakenings from sleep and increased subjective sleep quality. There was no effect on subjective TST or subjective SOL.
CONCLUSIONS


This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality. These data support the notion that baclofen shows promise as an effective hypnotic drug.",2020,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,['20 healthy subjects to'],"['baclofen', 'baclofen or placebo', 'Baclofen or placebo', 'placebo']","['subjective awakenings from sleep and increased subjective sleep quality', 'sleep parameters', 'sleep onset latency (SOL', 'subjective TST or subjective SOL', 'total sleep time (TST), sleep efficiency, and stage 3/4 sleep', 'objective wake after sleep onset and stage 1 sleep', 'sleep quality', 'objective and subjective sleep measures']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.028149,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,"[{'ForeName': 'Samih', 'Initials': 'S', 'LastName': 'Raad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Samih-Raad@ouhsc.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Wilkerson', 'Affiliation': 'Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: Meredith-Wilkerson@ouhsc.edu.'}, {'ForeName': 'Kellie R', 'Initials': 'KR', 'LastName': 'Jones', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Kellie-Jones@ouhsc.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'University of Oklahoma Health Sciences Center, Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: worr@lhsi.net.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.028']
1349,32619848,The influence of placebo administration on the first- night effect in patients with insomnia disorder.,"OBJECTIVE


We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs.
METHODS


In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights.
RESULTS


The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
CONCLUSION


In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.",2020,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","['patients with insomnia disorder', 'Twenty patients with insomnia disorder (drug-free group, DF', 'All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory', '36 patients with insomnia disorder who met the DSM-5 criteria', 'insomniacs', 'Sixteen patients with insomnia disorder']","['placebo intervention (placebo-administration group, PL', 'placebo']","['duration and percentage of N1, N2, N3 and REM', 'Sleep diaries', 'occurrence of worse sleep', 'lower self-reported total sleep time (TST) and more subjective WASO', 'sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO', 'sleep efficiency (SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",36.0,0.0242769,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","[{'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Yuezhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neuropsychiatry, Behavioral Neurology and Sleep Center, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Sleep Medicine Center, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Physiology, College of Basic Medicine, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Translational Neuroscience Center, State Key Laboratory, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 2372564613@qq.com.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China. Electronic address: sunhq@bjmu.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.002']
1350,32622346,Effect of Lower Blood Pressure Goals on Left Ventricular Structure and Function in Patients With Subclinical Hypertensive Heart Disease.,"BACKGROUND


Subclinical hypertensive heart disease (SHHD) is a precursor to heart failure. Blood pressure (BP) reduction is an important component of secondary disease prevention in patients with SHHD. Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg), may lead to improved cardiac function but there has been limited study of this, particularly in African Americans (AAs).
METHODS


We conducted a single center, randomized controlled trial where subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm Hg) BP therapy groups with quarterly follow-up for 12 months. The primary outcome was the differences of BP reduction between these 2 groups and the secondary outcome was the improvement in echocardiographic measures at 12 months.
RESULTS


Patients (95% AAs, 65% male, mean age 49.4) were randomized to the standard (n = 65) or the intensive (n = 58) BP therapy groups. Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg, respectively) (P < 0.05), no significant differences were noted between intention-to-treat groups (P = 0.33) or the proportion with resolution of SHHD (P = 0.31). However, on post hoc analysis, achievement of a sBP <130 mm Hg was associated with significant reduction in indexed left ventricular mass (-6.91 gm/m2.7; P = 0.008) which remained significant on mixed effect modeling (P = 0.031).
CONCLUSIONS


In post hoc analysis, sBP <130 mm Hg in predominantly AA patients with SHHD was associated with improved cardiac function and reverse remodeling and may help to explain preventative effects of lower BP goals.
CLINICAL TRIALS REGISTRATION


Trial Number NCT00689819.",2020,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","['subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm', 'Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg', 'patients with SHHD', 'Hg', 'Patients (95% AAs, 65% male, mean age 49.4', 'Subclinical hypertensive heart disease (SHHD', 'African Americans (AAs']",[],"['cardiac function and reverse remodeling', 'Blood pressure ', 'systolic BP (sBP', 'BP reduction', 'indexed left ventricular mass', 'cardiac function', 'echocardiographic measures']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0152105', 'cui_str': 'Hypertensive heart disease'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}]",[],"[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.120816,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","[{'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burla', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, Michigan, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Twiner', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Marinica', 'Affiliation': 'Department of Surgery, Sinai-Grace Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Mahn', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Brody', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ehrman', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Brodsky', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Integrative Biosciences Center, Clinical Research Division, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Samar A', 'Initials': 'SA', 'LastName': 'Nasser', 'Affiliation': 'Department of Clinical Research and Leadership, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flack', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University, Springfield, Illinois, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa108']
1351,32623701,"Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome: A Randomized, Placebo-Controlled Trial.","OBJECTIVE


To evaluate the efficacy and safety of administration of the formulated Persian herbal syrup on improving the symptoms of patients with constipation-predominant irritable bowel syndrome (IBS-C).
METHODS


This study was conducted in 70 patients with IBS-C, who were recruited from 3 medical centers in Mashhad, Iran, from November 2017 to August 2018. Seventy patients were randomly assigned to 2 groups including treatment and placebo groups by block randomization, 35 cases in each group. Patients in the treatment group received 15 mL of anti-IBS syrup, thrice daily for 6 weeks and followed up for 4 weeks. Placebo syrup was also prepared through similar instruction, BP syrup without plant extract was used. Primary outcome induding IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS) were completed and evaluated at weeks 6 and 10, respectively. Safety indices were collected at the end of the treatment and Common Terminology Criteria for Adverse Events v4.0 (CTCAE) was used to evaluate the adverse events.
RESULTS


The response to treatment was 84.4% (27/32) in the treatment group and 46.4% (13/28) in the placebo group, respectively (P= 0.002). Compared with pre-treatment, a significant decrease was found on the IBS-SSS and BSFS scores after 6-week intervention in both groups (P<0.001). Moreover, IBS-SSS and BSFS scores in the treatment group were lower than the placebo group after the intervention (P=0.041). There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05). Side effects reported in the treatment group included 2 cases of headache during the first week of the onset of the treatment, 1 case of drowsiness, 1 case of increase in menstrual bleeding, which did not result in discontinuation of the treatment. In the placebo group, 1 case of exacerbation of the disease was reported.
CONCLUSIONS


Anti-IBS syrup significantly reduced the severity of IBS symptoms compared to placebo. However, there was a need for further investigation regarding the anxiety and depression scores. (Registration No. IRCT2017061034446N1).",2020,There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05).,"['Anti-irritable Bowel Syndrome Syrup Improves Constipation-Predominant Irritable Bowel Syndrome', 'Seventy patients', '70 patients with IBS-C, who were recruited from 3 medical centers in Mashhad, Iran, from November 2017 to August 2018', 'patients with constipation-predominant irritable bowel syndrome (IBS-C']","['formulated Persian herbal syrup', 'Placebo', '15 mL of anti-IBS syrup', 'placebo']","['Safety indices', 'headache', 'severity of IBS symptoms', 'IBS-SSS and BSFS scores', 'anxiety and depression scores', 'menstrual bleeding', 'IBS Symptom Severity Scale (IBS-SSS) questionnaire and secondary outcomes in terms of Hospital Anxiety and Depression (HADS) questionnaires, the Bristol Stool Form Scale (BSFS', 'Side effects', 'efficacy and safety']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1868889', 'cui_str': 'Irritable bowel syndrome characterized by constipation'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",70.0,0.106066,There was no significant difference in the anxiety and depression scores after treatment in both groups (P>0.05).,"[{'ForeName': 'Hamide Khorram', 'Initials': 'HK', 'LastName': 'Pazhouh', 'Affiliation': 'Persian Medicine, Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran.'}, {'ForeName': 'Seyyd Musa Al-Reza', 'Initials': 'SMA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, 91776699199, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghipour', 'Affiliation': 'Faculty of Health, Mashhad University of Medical Sciences, Mashhad, 9137673119, Iran.'}, {'ForeName': 'Shokouhsadat', 'Initials': 'S', 'LastName': 'Hamedi', 'Affiliation': 'Department of Persian Pharmacy, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Noras', 'Affiliation': 'Persian Traditional Medicine, Faculty of Persian Traditional and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, 9177899191, Iran. NorasMR@mums.ac.ir.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3267-4']
1352,32631366,Prompting consumers to make healthier food choices in hospitals: a cluster randomised controlled trial.,"BACKGROUND


Hospitals in the UK offer snacks for sale to patients, staff and visitors. Despite the NHS's health promoting role, and tightening of regulations around which foods can be sold in hospitals, many snacks purchased in this setting are unhealthy. The present project tests the effectiveness of theory-based point of purchase prompts (PPPs; a form of cognitive nudge) designed to make it cognitively easier for consumers to compare available products and choose healthier options.
METHODS


Hospital shops in Scotland (n = 30) were recruited into a cluster randomised controlled trial to test whether a PPP could reduce the average calorie, fat and/or sugar content of purchased snacks. Inclusion criteria stated that eligible sites; sold food; were located in a hospital; and were accessible to staff, patients and visitors. The PPP intervention was a theory-based sign (tailored to the available range in each location) designed to cognitively simplify healthier snack choices by facilitating cross-product comparison. Shops were randomised to display PPPs (intervention; n = 15) or not (control; n = 15) using block randomisation controlling for shop size. Data on all snacks purchased from participating shops were obtained from retailers for a 12-week baseline and 12-week follow-up period. Primary outcomes were the average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day. Secondary outcomes were the average customer spend per item purchased (£,p) and the total number of snacks purchased daily. Shop staff were not blinded to group assignment but data providers were. Data were analysed using mixed effects multi-level regression models.
RESULTS


Data from > 1 million snack purchases were analysed. Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control. Average spend per item also reduced significantly in intervention (but not control) sites (γ = - 0.89, p < .001). The intervention had no effect on the fat content of snacks or the number of snacks sold.
CONCLUSIONS


Simple, theory-based point of purchase prompts can produce small but statistically significant reductions in the energy content of snack purchases from hospital shops.
TRIAL REGISTRATION


Retrospectively registered (8/Oct/2018) with ISRCTN (ID: ISRCTN90365793 ).",2020,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","['hospitals', 'Hospital shops in Scotland (n\u2009=\u200930']","['display PPPs (intervention; n\u2009=\u200915) or not (control; n\u2009=\u200915) using block randomisation controlling for shop size', 'PPP', 'PPP intervention', 'theory-based point of purchase prompts (PPPs']","['average customer spend per item purchased (£,p) and the total number of snacks purchased daily', 'average calorie (kcals), fat(g) and sugar(g) content of snacks purchased each day', 'fat content of snacks or the number of snacks sold']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019987', 'cui_str': 'Hospital Shop'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C2742135', 'cui_str': 'SELL protein, human'}]",30.0,0.0862335,"Snacks purchased from intervention sites were on average significantly lower in calorie (γ = - 1.84, p < .001) and sugar (γ = - 0.18, p = .030) at follow up relative to baseline but only the reduction in calories was significantly different to control.","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Allan', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland. j.allan@abdn.ac.uk.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Powell', 'Affiliation': 'Health Psychology, Institute of Applied Health Sciences, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK, Scotland.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00990-z']
1353,32634654,Effectiveness of mechanical debridement with and without adjunct antimicrobial photodynamic for treating peri-implant mucositis among prediabetic cigarette-smokers and non-smokers.,"AIM


The aim of the present study was to compare the effectiveness of mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT) for treating peri-implant mucositis among prediabetic cigarette-smokers and non-smokers.
METHODS


Prediabetic and non-diabetic smokers and non-smokers with peri-implant mucositis were included. Patients with peri-implant mucositis were divided into 4 groups as follows: Group-1: Prediabetic smokers with peri-implant mucositis; Group-2: Prediabetic non-smokers with peri-implant mucositis; Group-3: Systemically-healthy smokers with peri-implant mucositis; and Group-4: Systemically-healthy non-smokers with peri-implant mucositis. Hemoglobin A1c levels were measured in all groups prior to MD with adjunct aPDT. Peri-implant plaque index (PI), bleeding on probing (BOP) and probing depth (PD) were assessed at baseline and at 4- and 12-weeks of follow-up. Sample-size estimation was done and data normality was assessed. Group-comparisons were performed. and P < 0.01 was selected as an indicator of statistical significance.
RESULTS


Fifteen, 15, 15 and 15 individuals were included in groups 1, 2, 3 and 4, respectively. At baseline, peri-implant PI, BOP and PD were comparable in all groups. In prediabetic smokers and non-smokers, there was no significant difference in peri-implant PI, BOP and PD at 4- and 12-weeks' follow-up. Among non-diabetic smokers and non-smokes MD with adjunct PDT significant reduced PI (P < 0.01) and PD (P < 0.01) at 4- and 12-weeks' follow-up.
CONCLUSION


The outcomes of MD with adjunct aPDT for the treatment of peri-implant mucositis are compromised in smokers and non-smokers with prediabetes. In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.",2020,"In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.","['Prediabetic and non-diabetic smokers and non-smokers with peri-implant mucositis were included', 'Group-1: Prediabetic smokers with peri-implant mucositis; Group-2: Prediabetic non-smokers with peri-implant mucositis; Group-3: Systemically-healthy smokers with peri-implant mucositis; and Group-4: Systemically-healthy non-smokers with peri-implant mucositis', 'prediabetic cigarette-smokers and non-smokers', 'Patients with peri-implant mucositis']","['aPDT', 'MD with adjunct aPDT', 'mechanical debridement (MD) with and without adjunct antimicrobial photodynamic therapy (aPDT', 'mechanical debridement with and without adjunct antimicrobial photodynamic']","['Hemoglobin A1c levels', 'peri-implant mucositis', 'Peri-implant plaque index (PI), bleeding on probing (BOP) and probing depth (PD', 'peri-implant PI, BOP and PD']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.010401,"In non-diabetic smokers and non-smokers, MD with aPDT is effective for treating peri-implant mucositis.","[{'ForeName': 'Ahmed Saleh Saeed', 'Initials': 'ASS', 'LastName': 'Al Hafez', 'Affiliation': 'Public Health Department, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia. Electronic address: ahmed.s.alhafez@student.riyadh.edu.sa.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Ingle', 'Affiliation': 'Public Health Department, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Alathra Abdullah', 'Initials': 'AA', 'LastName': 'Alshayeb', 'Affiliation': 'Dental Center Albaha, Aljubail, Alhassa, Saudi Arabia.'}, {'ForeName': 'Hamed Mohammad', 'Initials': 'HM', 'LastName': 'Tashery', 'Affiliation': 'Qunfidhah Dental Center, AlQunfidhah, Saudi Arabia.'}, {'ForeName': 'Abdulrahman Abdullah Mohammad', 'Initials': 'AAM', 'LastName': 'Alqarni', 'Affiliation': 'Dammam Medical Complex, AlKhubar, Saudi Arabia.'}, {'ForeName': 'Salma Hamed', 'Initials': 'SH', 'LastName': 'Alshamrani', 'Affiliation': 'Dental Center Albaha, Aljadin, Ishbiliyah, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101912']
1354,32636324,One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study.,"OBJECTIVE


To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.
METHODS


Patients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed.
RESULTS


Mean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70 mg) and -4.6 (0.2)/-1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), -1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.
CONCLUSION


Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
CLINICALTRIALSGOV IDENTIFIER


NCT02456740.
CLASSIFICATION OF EVIDENCE


Class II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.",2020,"Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
","['845 patients', 'patients with episodic migraine', 'Patients were randomized ( n =955; 1:1:1) during the 24-week', 'episodic migraine']","['erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP', 'double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg']","['safety profiles', 'MMD, and safety/tolerability', 'efficacy and tolerability', 'sustained responses', 'MMD', 'Mean MMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",845.0,0.0624176,"Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland. peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Hallström', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Jo H', 'Initials': 'JH', 'LastName': 'Bonner', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Ian K', 'Initials': 'IK', 'LastName': 'Wright', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Chou', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Picard', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': ""From the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.""}]",Neurology,['10.1212/WNL.0000000000010019']
1355,32623947,"Is ""Response/No Response"" Too Simple a Notion for RTI Frameworks? Exploring Multiple Response Types With Latent Profile Analysis.","We conducted a secondary analysis of data from a randomized control trial to explore this question: Does ""response/no response"" best characterize students' reactions to a generally efficacious first-grade reading program, or is a more nuanced characterization necessary? Data were collected on 265 at-risk readers' word reading prior to and immediately following program implementation in first grade and in spring of second grade. Pretreatment data were also obtained on domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning). Latent profile analysis of word reading across the three time points with controls as a local norm revealed a  strongly responsive  group ( n  = 45) with mean word-reading  z  scores of 0.25, 1.64, and 1.26 at the three time points, respectively; a  mildly responsive  group ( n  = 109),  z  scores = 0.30, 0.47, and 0.55; a  mildly non-responsive  group ( n  = 90),  z  scores = -0.11, -0.15, and -0.55; and a  strongly non-responsive  group ( n  = 21),  z  scores = -1.24, -1.26, and -1.57. The two responsive groups had stronger pretreatment letter knowledge and passage comprehension than the two non-responsive groups. The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group. No domain-general skill distinguished the four groups. Findings suggest response to early reading intervention was more complicated than response/no response, and pretreatment reading comprehension was an important predictor of response even with pretreatment word reading controlled.",2020,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,[],[],"['Response', 'pretreatment passage comprehension', 'stronger pretreatment letter knowledge and passage comprehension', 'domain-specific skills (letter knowledge, decoding, passage comprehension, language) and domain-general skills (working memory, non-verbal reasoning']",[],[],"[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0174433,The mildly non-responsive group demonstrated better pretreatment passage comprehension than the strongly non-responsive group.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Peng', 'Affiliation': 'University of Texas at Austin, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Michigan State University, East Lansing, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Elleman', 'Affiliation': 'Middle Tennessee State University, Mufreesboro, USA.'}, {'ForeName': 'Devin M', 'Initials': 'DM', 'LastName': 'Kearns', 'Affiliation': 'University of Connecticut, Storrs, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Patton', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Compton', 'Affiliation': 'Florida State University, Tallahassee, USA.'}]",Journal of learning disabilities,['10.1177/0022219420931818']
1356,32631586,A randomized trial on the effect of oral combined estradiol and drospirenone on glucose and insulin metabolism in healthy menopausal women with a normal oral glucose tolerance test.,"BACKGROUND


Menopause is often associated with a central accumulation of body fat. This provokes insulin resistance. The resulting hyperinsulinemia may increase the risk of diabetes, cardiovascular disease and breast cancer. Long-term studies indicate that menopausal hormone therapy (MHT) reduces insulin resistance. To broaden knowledge of the mechanisms behind the influence of MHT on glucose homeostasis we focused on the direct short-term effects of MHT with oral combined estradiol and drospirenone on glucose and insulin metabolism in healthy postmenopausal women.
METHODS


This randomized, placebo-controlled study recruited 80 healthy postmenopausal women. Women were randomized to treatment with estradiol 1 mg continuously combined with drospirenone 2 mg or placebo for 6-8 weeks. All participants underwent an oral glucose tolerance test (OGTT) before and after the treatment period. Glucose, insulin, fructosamine and C-peptide levels were measured in serum before and 30, 60, 90, 120 and 150 min after a 75-gram oral glucose challenge.
RESULTS


After intervention, significantly higher glucose levels at 120 min (p < 0.024) and 150 min (p < 0.030) were observed in the MHT group compared with the placebo group. These glucose levels remained within the normal range. A significantly lower insulin peak serum level (p < 0.040) and a non-significantly smaller area under the curve (AUC) for insulin levels (p = 0.192) was observed in the MHT group at the end of the study period relative to baseline. No significant change in the insulin AUC in the placebo group was observed. There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
CONCLUSION


This double-blind randomized study (EC/2008/694) indicates that treating healthy, postmenopausal women with 1 mg estradiol continuously combined with 2 mg drospirenone significantly decreases peak insulin levels and increases peak glucose levels during an OGTT compared to placebo. These glucose levels remained within the normal range.",2020,"There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
","['healthy, postmenopausal women with 1\u202fmg estradiol continuously combined with 2\u202fmg', 'healthy menopausal women with a normal oral glucose tolerance test', 'healthy postmenopausal women', '80 healthy postmenopausal women']","['estradiol 1\u202fmg continuously combined with drospirenone 2\u202fmg or placebo', 'estradiol and drospirenone', 'oral glucose tolerance test (OGTT', 'drospirenone', 'menopausal hormone therapy (MHT', 'oral combined estradiol and drospirenone', 'placebo']","['Glucose, insulin, fructosamine and C-peptide levels', 'insulin peak serum level', 'risk of diabetes, cardiovascular disease and breast cancer', 'peak glucose levels', 'higher glucose levels', 'peak insulin levels', 'glucose levels', 'smaller area under the curve (AUC) for insulin levels', 'insulin AUC', 'fructosamine, HOMA-IR and C-peptide levels', 'glucose and insulin metabolism']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0985841', 'cui_str': 'Estradiol 1 MG'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1670781', 'cui_str': 'drospirenone 2 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",80.0,0.368072,"There were no significant differences in fructosamine, HOMA-IR and C-peptide levels between the MHT group and the placebo group.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium. Electronic address: herman.depypere@ugent.be.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dierickx', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vandevelde', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Stanczyk', 'Affiliation': 'Departments of Obstetrics and Gynecology, and Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ottoy', 'Affiliation': 'Breast and Menopause Clinic, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delanghe', 'Affiliation': 'Department Clinical Chemistry, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, Belgium.'}]",Maturitas,['10.1016/j.maturitas.2020.04.009']
1357,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
1358,32640411,"The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.","BACKGROUND


Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change.
METHODS


A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA).
RESULTS


Analysis yielded three overarching themes: taking part in a treatment trial - ""the only thing out there"", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an ""unpredictable recovery"".
CONCLUSIONS


People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.",2020,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","['participants with dissociative seizures', 'adults with Dissociative non-Epileptic Seizures (CODES) Trial', '30 participants in an', 'people with dissociative seizures (DS']","['DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC', 'RCT (the COgnitive behavioral therapy vs standardized medical care']",[],"[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",[],30.0,0.0596229,"Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purnell', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107230']
1359,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1360,32635650,Mind over Matter: Testing the Efficacy of an Online Randomized Controlled Trial to Reduce Distraction from Smartphone Use.,"Evidence suggests a growing call for the prevention of excessive smartphone and social media use and the ensuing distraction that arises affecting academic achievement and productivity. A ten-day online randomized controlled trial with the use of smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking, was implemented amongst UK university students ( n  = 143). Participants were asked to complete online pre- and post-intervention assessments. Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes. The intervention was not effective in reducing habitual behaviours, nomophobia, or time spent on social media. Mediation analyses demonstrated that: (i) emotional self-awareness but not mindful attention mediated the relationship between intervention effects and smartphone distraction, and (ii) online vigilance mediated the relationship between smartphone distraction and problematic social media use. The present study provides preliminary evidence of the efficacy of an intervention for decreased smartphone distraction and highlights psychological processes involved in this emergent phenomenon in the smartphone literature. Online interventions may serve as complementary strategies to reduce distraction levels and promote insight into online engagement. More research is required to elucidate the mechanisms of digital distraction and assess its implications in problematic use.",2020,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,['UK university students ( n  = 143'],"['smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking', 'Mind over Matter']","['smartphone distraction and improvement scores', 'habitual behaviours, nomophobia, or time spent on social media']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]",,0.0449527,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,"[{'ForeName': 'Melina A', 'Initials': 'MA', 'LastName': 'Throuvala', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Rennoldson', 'Affiliation': 'Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Daria J', 'Initials': 'DJ', 'LastName': 'Kuss', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17134842']
1361,32638031,[Sucrose octasulfate-evidence in the treatment of chronic wounds].,"Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area. One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate. For wound products containing TLC-sucrose octasulfate, several sequential clinical studies have been conducted in recent years. The WHAT study was an open randomized controlled trial (RCT) with 117 patients with venous leg ulcers (VLU). The CHALLENGE study was a double-blind RCT with 187 patients with VLU. The SPID study was a pilot study with 33 patients with diabetic foot ulcers (DFU). The two prospective, multicenter clinical pilot studies NEREIDES and CASSIOPEE examined a total of 88 patients with VLU in different phases of healing. In the REALITY study, a pooled data analysis was performed on eight observational studies with 10,220 patients with chronic wounds of different genesis. In the double-blind, two-armed EXPLORER RCT, 240 patients with neuro-ischemic DFU were followed from first presentation until complete healing. In all studies, a significant promotion of wound healing could be shown by the use of wound healing products with TLC-sucrose octasulfate.",2020,"One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate.","['10,220 patients with chronic wounds of different genesis', 'chronic wounds', '240 patients with neuro-ischemic DFU', '88\xa0patients with VLU in different phases of healing', '187 patients with VLU', '33\xa0patients with diabetic foot ulcers (DFU', 'Patients with chronic wounds', '117 patients with venous leg ulcers (VLU']",['TLC-sucrose octasulfate (TLC: technology lipido-colloid'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C4255166', 'cui_str': 'Genesis'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0473559', 'cui_str': 'Ischemic ulcer diabetic foot'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0075479', 'cui_str': 'sucrose octasulfate'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}]",[],240.0,0.0518699,"One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate.","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dissemond', 'Affiliation': 'Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstr.\xa055, 45147, Essen, Deutschland. joachim.dissemond@uk-essen.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Diabetesschwerpunktpraxis Dietlein, Bauernstr.\xa050, 86391, Stadtbergen, Deutschland.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Keuthage', 'Affiliation': 'Schwerpunktpraxis Diabetes und Ernährungsmedizin, MedicalCenter am Clemenshospital, Düesbergweg\xa0128, 48153, Münster, Deutschland.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Läuchli', 'Affiliation': 'Dermatologische Klinik, Universitätsspital Zürich, Gloriastr.\xa031, 8091, Zürich, Schweiz.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lobmann', 'Affiliation': 'Klinik für Endokrinologie, Diabetologie und Geriatrie, Klinikum Stuttgart - Krankenhaus Bad Cannstatt, Prießnitzweg\xa024, 70374, Stuttgart, Deutschland.'}, {'ForeName': 'Karl-Christian', 'Initials': 'KC', 'LastName': 'Münter', 'Affiliation': 'Gemeinschaftspraxis Bramfeld, Bramfelder Chaussee\xa0200, 22177, Hamburg, Deutschland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stücker', 'Affiliation': 'Abteilung für Dermatologie und Venerologie, LKH Feldkirch, Akademisches Lehrspital, Carinagasse 45-47, 6800, Feldkirch, Österreich.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Traber', 'Affiliation': 'Abteilung für Dermatologie Venerologie und Allergologie am St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Gudrunstr.\xa056, 44791, Bochum, Deutschland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Vanscheidt', 'Affiliation': 'Venenklinik Bellevue, Brückenstr.\xa09, 8280, Kreuzlingen, Schweiz.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strohal', 'Affiliation': 'Dermatologische Gemeinschaftspraxis, Paula-Modersohn-Platz\xa03, 79100, Freiburg, Deutschland.'}]","Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete",['10.1007/s00105-020-04637-9']
1362,32639946,A validated survival nomogram for early-onset diffuse gastric cancer.,"This study aimed to establish and independently validate a prognostic nomogram for individual risk prediction in patients with early-onset diffuse gastric cancer (EODGC). Data for 794 patients with EODGC from the SEER database were randomly assigned to training (N=558) and internal validation (N=236) sets, and data for 82 patients from the Renmin Hospital of Wuhan University (RMHWHU) were used as an independent validation cohort. Our LASSO regression analyses of the training set yielded five clinicopathological features (race, AJCC stage, surgery for primary site, chemotherapy and tumor size), which were used to create a survival nomogram. Our survival nomogram achieved better predictive performance than the AJCC staging system, the current standard. Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values. Indeed, our nomogram, which estimates individualized survival probabilities for patients with EODGC, shows good predictive accuracy and calibration ability for both the SEER and RMHWHU cohorts. These results suggest that a survival nomogram may be better at predicting OS for EODGC patients than the AJCC staging system.",2020,"Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values.","['82 patients from the Renmin Hospital of Wuhan University (RMHWHU) were used as an independent validation cohort', '794 patients with EODGC from the SEER database', 'early-onset diffuse gastric cancer', 'patients with early-onset diffuse gastric cancer (EODGC']",[],"['survival probabilities', 'individualized survival probabilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",794.0,0.0291444,"Additionally, the calibration curves of the prognostic nomogram revealed good agreement between the predicted survival probabilities and the ground truth values.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Oncology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan 430061, Hubei Province, China.'}]",Aging,['10.18632/aging.103406']
1363,32648429,Editorial Comment: Cardiovascular Morbi-dity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.,,2020,,['Pati-ents with Advanced Prostate Cancer and Preexisting Cardiovascular Disease'],['GnRH Agonist and GnRH Antagonist'],[],"[{'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]",[],,0.0524597,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.09']
1364,32643385,"Peer engagement in toddlers with autism: Community implementation of dyadic and individual Joint Attention, Symbolic Play, Engagement, and Regulation intervention.","LAY ABSTRACT


Although young children may participate in education and intervention programs that take place in classrooms or groups, there is little information about how toddlers with special needs, and specifically toddlers with autism, are engaging with their peers. This study takes place in a public center-based early intervention program for toddlers with autism. Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer. Children in both groups made gains in social communication and play skills. Children who had the peer intervention were more engaged with peers when an adult was present, but not when the children were unsupported. This article adds information about early skills that may be important for children to master so that they have more success when trying to interact with their peers. These skills include understanding language (referred to as ""receptive language"" at 12 months or more) and play skills including building and stacking (referred to as ""combination play""-for example, building with blocks or completing a puzzle) and extending familiar actions to themselves, others, and figures (referred to as ""presymbolic play""-for example, putting a bottle to the doll or to themselves). Understanding which skills to target can help practitioners focus their instruction to build children's skills toward connecting with peers through play.",2020,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"['Classrooms of toddlers', 'young children', 'toddlers with autism']",['individual social communication intervention or the same intervention adapted to include a peer'],['social communication and play skills'],"[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",,0.0213406,Classrooms of toddlers were randomly assigned to an individual social communication intervention or the same intervention adapted to include a peer.,"[{'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Shire', 'Affiliation': 'University of Oregon, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bracaglia', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kodjoe', 'Affiliation': 'New York Center for Child Development, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California, Los Angeles, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320935689']
1365,32643163,Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials.,"OBJECTIVE


To analyze the effects of a standardized community health worker (CHW) intervention on hospitalization.
DATA SOURCES/STUDY SETTING


Pooled data from three randomized clinical trials (n = 1340) conducted between 2011 and 2016.
STUDY DESIGN


The trials in this pooled analysis were conducted across diseases and settings, with a common study design, intervention, and outcome measures. Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured. They were randomly assigned to receive usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation. Trial one (n = 446) tested two weeks of IMPaCT among hospitalized general medical patients. Trial two (n = 302) tested six months of IMPaCT among outpatients at two academic primary care clinics. Trial three (n = 592) tested six months of IMPaCT among outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices.
DATA COLLECTION/EXTRACTION METHODS


The primary outcome for this study was all-cause hospitalization, as measured by total number of hospital days per patient. Hospitalization data were collected from statewide or VA databases at 30 days postenrollment in Trial 1, twelve months postenrollment in Trial 2, and nine months postenrollment in Trial 3.
PRINCIPAL FINDINGS


Over 9398 observed patient months, the total number of hospital days per patient in the intervention group was 66 percent of the total in the control group (849 days for 674 intervention patients vs 1258 days for 660 control patients, incidence rate ratio (IRR) 0.66, P < .0001). This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03). The intervention also decreased rates of hospitalization outside patients' primary health system (18.8 percent vs 34.8 percent, P = .0023).
CONCLUSIONS


Data from three randomized clinical trials across multiple settings show that a standardized CHW intervention reduced total hospital days and hospitalizations outside the primary health system. This is the largest analysis of randomized trials to demonstrate reductions in hospitalization with a health system-based social intervention.",2020,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","['Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured', 'outpatients at two academic primary care clinics', 'hospitalized general medical patients', 'outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices', 'Pooled data from three randomized clinical trials (n\xa0', 'disadvantaged patients with multiple chronic conditions', '1340) conducted between 2011 and 2016']","['standardized community health worker intervention', 'standardized CHW intervention', 'usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation', 'standardized community health worker (CHW) intervention']","['incidence rate ratio', 'total hospital days and hospitalizations', ""rates of hospitalization outside patients' primary health system"", 'total number of hospital days per patient', 'shorter mean length of stay', 'cause hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.281442,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Vasan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Morgan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mitra', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Kangovi', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Health services research,['10.1111/1475-6773.13321']
1366,32640131,A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.,"BACKGROUND


Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.
METHODS


We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.
RESULTS


The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.
CONCLUSIONS


A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).",2020,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"['participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women', '86 primary care practices across 10 health care systems', 'older adults', 'participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries']","['multifactorial intervention', 'intervention or to enhanced usual care (the control']","['time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data', 'rate of a first adjudicated serious fall injury', 'rate of a first participant-reported fall injury', 'rates of hospitalization or death']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085639', 'cui_str': 'Falls'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2802.0,0.136147,A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each).,"[{'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McMahon', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Gazarian', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goehring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fagan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Wiggins', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Ko', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Siu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Wu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rich', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Waring', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Carri', 'Initials': 'C', 'LastName': 'Casteel', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Resnick', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Haseena', 'Initials': 'H', 'LastName': 'Rajeevan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Allore', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Brooke F', 'Initials': 'BF', 'LastName': 'Brawley', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rich', 'Initials': 'R', 'LastName': 'Eder', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Boult', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Rosaly', 'Initials': 'R', 'LastName': 'Correa-de-Araujo', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': ""From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2002183']
1367,32645310,A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.,"PURPOSE


To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy.
DESIGN


Prospective, randomized, interventional study.
METHODS


This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates.
RESULTS


Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates.
CONCLUSION


Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.",2020,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","['Participants (n=100', 'academic setting Patient or Study Population: Patients older than 18 years with medically uncontrolled glaucoma and no previous history of incisional glaucoma surgery Intervention or Observation Procedure(s): Subjects', 'Trabeculectomy', 'Subjects with medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy is indicated']","['Subconjunctival Injection', 'MMC delivery (subconjunctival injection and direct scleral application', 'mitomycin C (MMC', 'Subconjunctival 5-fluorouracil injections', 'preoperative subconjunctival injection or intraoperative direct scleral application using surgical sponges during trabeculectomy', 'Mitomycin C', 'MMC']","['number of glaucoma medications', 'bleb height', 'bleb vascularity', 'bleb extension', 'number of IOP lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates', 'mean IOP', 'surgical success', 'surgical outcomes and bleb morphologies']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0197180', 'cui_str': 'Subconjunctival injection'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038937', 'cui_str': 'Surgical sponge'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",100.0,0.153502,"At six months, there were no significant differences between the injection (n = 38) and sponge (n = 40) group in surgical success (p = 0.357), mean IOP (p = 0.707), number of glaucoma medications (p = 1.000), bleb height (p = 0.625), bleb extension (p = 0.216), bleb vascularity (p = 0.672), or complications rates.
","[{'ForeName': 'Jiun L', 'Initials': 'JL', 'LastName': 'Do', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Xu', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'USC Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine at the University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Camp', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ngai', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Long', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Sasan', 'Initials': 'S', 'LastName': 'Moghimi', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Diya', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Welsbie', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Weinreb', 'Affiliation': 'Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, California, USA. Electronic address: rweinreb@health.ucsd.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.002']
1368,32650671,Editorial: Clinical trial design in the era of COVID-19.,,2020,,[],[],[],[],[],[],,0.137778,,"[{'ForeName': 'Colin B', 'Initials': 'CB', 'LastName': 'Begg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mithat', 'Initials': 'M', 'LastName': 'Gonen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Heitjan', 'Affiliation': 'Department of Statistical Science, Southern Methodist University, Dallas, TX, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520940230']
1369,32649615,Valproic acid decreases resuscitation requirements after hemorrhage in a prolonged damage-control resuscitation model.,"BACKGROUND


Hemorrhage is the leading cause of preventable death in trauma. Future military conflicts are likely to be in austere environments, where prolonged damage-control resuscitation (p-DCR) may be required for 72 hours before evacuation. There is a need to demonstrate that p-DCR is feasible and to optimize its logistics. Dried plasma (DP) is a practical alternative to conventional blood products in austere settings, and valproic acid (VPA) improves survival in preclinical models of trauma and hemorrhage. We performed the current experiment to study the synergistic effects of VPA and DP and hypothesized that VPA treatment would decrease the fluid resuscitation requirements in p-DCR.
METHODS


Female swine were subjected to 50% hemorrhage (associated with 20% survival using non-plasma-based p-DCR) and left unresuscitated for 1 hour to simulate medic response time. They were then randomized to receive VPA (150 mg/kg + DP 250 mL; DP-VPA group; n = 5) or DP alone (DP group; n = 6). All animals were resuscitated to a systolic blood pressure of 80 mm Hg with lactated Ringer according to the Tactical Combat Casualty Care Guidelines for 72 hours, after which packed red blood cells were transfused to simulate evacuation to higher levels of care.
RESULTS


The DP-VPA group needed significantly (p = 0.002) less volume of lactated Ringer to reach and maintain the target systolic blood pressure. This would translate to a 4.3 L volume sparing effect for a 70-kg person.
CONCLUSION


Addition of a single dose of VPA significantly decreases the volume of resuscitation required in a p-DCR model.",2020,The DP+VPA group needed significantly (p=0.002) less volume of LR to reach and maintain the target SBP.,['Female swine were subjected to 50% hemorrhage (associated with 20% survival using non-plasma-based p-DCR) and left unresuscitated for one hour to simulate medic response time'],"['kg+DP 250 mL; DP+VPA', 'VPA', ""lactated Ringer's (LR"", 'DP+VPA', 'VPA and DP', 'DP alone', 'Dried plasma (DP']","['volume of resuscitation', 'volume of LR to reach and maintain the target SBP', 'fluid resuscitation requirements', 'Valproic Acid Decreases Resuscitation Requirements', 'systolic blood pressure (SBP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0358142,The DP+VPA group needed significantly (p=0.002) less volume of LR to reach and maintain the target SBP.,"[{'ForeName': 'Ben E', 'Initials': 'BE', 'LastName': 'Biesterveld', 'Affiliation': 'From the Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Kemp', 'Affiliation': ''}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': ''}, {'ForeName': 'Ali Z', 'Initials': 'AZ', 'LastName': 'Siddiqui', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': ''}, {'ForeName': 'Alizeh', 'Initials': 'A', 'LastName': 'Shamshad', 'Affiliation': ''}, {'ForeName': 'Kiril', 'Initials': 'K', 'LastName': 'Chtraklin', 'Affiliation': ''}, {'ForeName': 'Umar F', 'Initials': 'UF', 'LastName': 'Bhatti', 'Affiliation': ''}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002876']
1370,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1371,32652516,Protein and calorie restriction may improve outcomes in living kidney donors and kidney transplant recipients.,"Previously, we and others showed that dietary restriction protects against renal ischemia-reperfusion injury in animals. However, clinical translation of preoperative diets is scarce, and in the setting of kidney transplantation these data are lacking. In this pilot study, we investigated the effects of five days of a preoperative protein and caloric dietary restriction (PCR) diet in living kidney donors on the perioperative effects in donors, recipients and transplanted kidneys. Thirty-five kidney donors were randomized into either the PCR, 30% calorie and 80% protein reduction, or control group without restrictions. Adherence to the diet and kidney function in donors and their kidney recipients were analyzed. Perioperative kidney biopsies were taken in a selected group of transplanted kidneys for gene expression analysis. All donors adhered to the diet. From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group. PCR-donor kidney recipients showed significantly improved kidney function and lower incidence of slow graft function and acute rejection. PCR inhibited cellular immune response pathways and activated stress-resistance signaling. These observations are the first to show that preoperative dietary restriction induces postoperative recovery benefits in humans and may be beneficial in clinical settings involving ischemia-reperfusion injury.",2020,"From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group.","['living kidney donors and kidney transplant recipients', 'donors and their kidney recipients', 'Thirty-five kidney donors', 'living kidney donors', 'donors, recipients and transplanted kidneys']","['PCR, 30% calorie and 80% protein reduction, or control group without restrictions', 'Protein and calorie restriction', 'preoperative protein and caloric dietary restriction (PCR) diet']","['kidney function of donors', 'Perioperative kidney biopsies', 'kidney function and lower incidence of slow graft function and acute rejection']","[{'cui': 'C4305252', 'cui_str': 'Live donor of kidney'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",,0.0125707,"From postoperative day 2 up until month 1, kidney function of donors was significantly better in the PCR-group.","[{'ForeName': 'Franny', 'Initials': 'F', 'LastName': 'Jongbloed', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron W F', 'Initials': 'RWF', 'LastName': 'de Bruin', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry Van', 'Initials': 'HV', 'LastName': 'Steeg', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Beekhof', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wackers', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Hesselink', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan H J', 'Initials': 'JHJ', 'LastName': 'Hoeijmakers', 'Affiliation': 'Department of Genetics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Martijn E T', 'Initials': 'MET', 'LastName': 'Dollé', 'Affiliation': 'Laboratory of Health Protection Research, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'Jan N M', 'Initials': 'JNM', 'LastName': 'IJzermans', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Aging,['10.18632/aging.103619']
1372,32650223,Skin carotenoids are inversely associated with adiposity in breast cancer survivors.,"Carotenoids are antioxidants which may mitigate some of the adverse effects of obesity, a condition associated with poor outcomes in breast cancer patients. We hypothesized that baseline skin carotenoids would be inversely associated with adiposity in breast cancer survivors and would increase with weight loss. Skin carotenoid score (SCS) was assessed by resonance Raman spectroscopy in breast cancer survivors (body mass index ≥25 kg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n = 47). Measurements included total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers. Associations between SCS, adiposity measures, and serum biomarkers were assessed at baseline, as was the change in SCS from baseline to 6 months, in the intervention and usual care groups. At baseline, SCS was inversely correlated with all adiposity measures (P ≤ .05). In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20). Baseline SCS was significantly inversely associated with log C-reactive protein levels (regression coefficient β ± SE: -0.051± 0.019; P = .011) and log leptin (β ± SE: -0.019± 0.009; P = .046), but the associations were no longer significant after adjustment for adiposity. Over the 6-month study, the intervention group had a 17.6% increase in SCS compared to a 1.5% decrease in the usual care group (P = .28). In our study of overweight and obese breast cancer survivors, dual-energy X-ray absorptiometry-measured body fat explained a large portion of the variation in skin carotenoids at baseline, suggesting a stronger association than that previously seen in studies using less accurate measures of adiposity.",2020,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","['breast cancer patients', 'breast cancer survivors', 'overweight and obese breast cancer survivors', 'breast cancer survivors (body mass index ≥25\u202fkg/m 2 ) enrolled in a 6-month randomized controlled weight loss trial (n\u202f=\u202f47']",[],"['Skin carotenoid score (SCS', 'log C-reactive protein levels', 'SCS', 'SCS, adiposity measures, and serum biomarkers', 'weight loss', 'adiposity measures', 'total body fat using dual-energy X-ray absorptiometry, height, weight, waist and hip circumference, dietary intake, and serum biomarkers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0209892,"In multivariate analyses, baseline percent body fat had the strongest association with baseline SCS (partial R 2 = 0.20).","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: brenda.cartmel@yale.edu.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: chelsea.anderson@cancer.org.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: melinda.irwin@yale.edu.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: maura.harrigan@yale.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale Cancer Center, PO Box 208028, New Haven, CT 06519; Yale School of Medicine, 333 Cedar St, New Haven, CT 06511. Electronic address: tara.sanft@yale.edu.'}, {'ForeName': 'Fangyong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511. Electronic address: fangyong.li@yale.edu.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Gellermann', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: werner@longevitylinkcorporation.com.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Ermakov', 'Affiliation': 'Longevity Link Corporation, 391 Chipeta Way, Suite E, Salt Lake City, UT 84108. Electronic address: igor@longevitylinkcorporation.com.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Ferrucci', 'Affiliation': 'Yale School of Public Health, 60 College St, New Haven, CT 06511; Yale Cancer Center, PO Box 208028, New Haven, CT 06519. Electronic address: leah.ferrucci@yale.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.012']
1373,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
1374,32645143,Smell-Based Memory Training: Evidence of Olfactory Learning and Transfer to the Visual Domain.,"Human and non-human animal research converge to suggest that the sense of smell, olfaction, has a high level of plasticity and is intimately associated with visual-spatial orientation and memory encoding networks. We investigated whether olfactory memory (OM) training would lead to transfer to an untrained visual memory (VM) task, as well as untrained olfactory tasks. We devised a memory intervention to compare transfer effects generated by olfactory and non-olfactory (visual) memory training. Adult participants were randomly assigned to daily memory training for about 40 days with either olfactory or visual tasks that had a similar difficulty level. Results showed that while visual training did not produce transfer to the OM task, olfactory training produced transfer to the untrained VM task. Olfactory training also improved participants' performance on odor discrimination and naming tasks, such that they reached the same performance level as a high-performing group of wine professionals. Our results indicate that the olfactory system is highly responsive to training, and we speculate that the sense of smell may facilitate transfer of learning to other sensory domains. Further research is however needed in order to replicate and extend our findings.",2020,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.",['Adult participants'],"['olfactory memory training', 'olfactory and non-olfactory (visual) memory training', 'Smell-based memory training', 'Olfactory training', 'daily memory training']","['olfactory memory task, olfactory training produced transfer to the untrained visual memory task', ""participants' performance on odor discrimination and naming tasks""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0220731,"Results showed that while visual training did not produce transfer to the olfactory memory task, olfactory training produced transfer to the untrained visual memory task.","[{'ForeName': 'Jonas K', 'Initials': 'JK', 'LastName': 'Olofsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ekström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Elmeri', 'Initials': 'E', 'LastName': 'Syrjänen', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter-Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': 'Umeå Center for Functional Brain Imaging, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Jonsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Gösta Ekman Laboratory, Department of Psychology, Stockholm University, Stockholm, Sweden.'}]",Chemical senses,['10.1093/chemse/bjaa049']
1375,32649638,Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk.,"OBJECTIVE


Investigate if changes in objective sleep quality index (SQI) assessed through cardiopulmonary-coupling analysis impacts blood pressure (BP) in patients with obstructive sleep apnea at high-cardiovascular risk.
METHODS


Secondary analysis of ECG and pulse-oximetry-[oxygen saturation (SpO2)] data from the Heart Biomarker Evaluation in Apnea Treatment study, multicenter, controlled trial in patients with cardiovascular disease and moderate-severe obstructive sleep apnea, randomly assigned to intervention of healthy lifestyle and sleep hygiene education (HLSE; control group), continuous positive airway pressure (CPAP) or nocturnal supplemental oxygen (NSO). Participants with good-quality ECG-signal and SpO2-signal (n = 241) were included.
RESULTS


CPAP-therapy significantly improved BP, with net average improvement in mean arterial blood pressure during sleep (MAP) when compared with nocturnal supplemental oxygen-therapy or healthy lifestyle and sleep education-therapy, -3.92 (P = 0.012) and -3.83 (P = 0.016), respectively. When stratified on the basis of baseline-SQI, CPAP-therapy improves 24-h MAP -3.02 (P = 0.030) and MAP -5.00 (P = 0.001), in patients with compromised baseline-SQI (SQI < 55). Stratifying the cohort based on changes in SQI during the study period (SQI-SQI), controlling for sex, age over 60, apnea-hypopnea index, SpO2 less than 80%, baseline BP and cardiovascular disease, significant differences are observed comparing the groups that Improved-SQI (SQI < 55, SQI ≥ 55) and Declined-SQI (SQI ≥ 55, SQI < 55) in MAP -4.87 (P = 0.046) and mean diastolic blood pressure (MDP) -4.42 (P = 0.026) as well as MAP -6.36 (P = 0.015), mean systolic blood pressure wake (MSP) -7.80 (P = 0.048) and MDP -5.64 (P = 0.009), respectively. Improved SQI reflects the magnitude of positive effect on BP which is reached mostly through initiation of CPAP-therapy.
CONCLUSION


Cardiopulmonary coupling-derived sleep quality impacted 24-h MAP and MDP, as well as BP during wake, in patients participating in the Heart Biomarker Evaluation in Apnea Treatment-study.",2020,(P = 0.046) and mean diastolic blood pressure (MDP) -4.42,"['patients participating in the Heart Biomarker Evaluation in Apnea Treatment-study', 'Participants with good-quality ECG-signal and SpO2-signal (n\u200a=\u200a241) were included', 'patients with obstructive sleep apnea at high-cardiovascular risk', 'patients with cardiovascular disease and moderate-severe obstructive sleep apnea']","['cardiopulmonary-coupling analysis impacts blood pressure (BP', 'healthy lifestyle and sleep hygiene education (control group), continuous positive airway pressure (CPAP) or nocturnal supplemental oxygen']","['blood pressure', 'mean arterial blood pressure during sleep (MAP', 'ECG and pulse-oximetry-[oxygen saturation (SpO2', 'objective sleep quality index (SQI', 'mean systolic blood pressure wake (MSP', 'mean diastolic blood pressure wake (MDP) -5.64', 'mean diastolic blood pressure (MDP) -4.42', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0026031', 'cui_str': 'Microspectrophotometry'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517762', 'cui_str': '4.42'}]",241.0,0.0331929,(P = 0.046) and mean diastolic blood pressure (MDP) -4.42,"[{'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Magnusdottir', 'Affiliation': 'MyCardio LLC, SleepImage, Denver, Colorado.'}, {'ForeName': 'Hugi', 'Initials': 'H', 'LastName': 'Hilmisson', 'Affiliation': 'MyCardio LLC, SleepImage, Denver, Colorado.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Thomas', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Journal of hypertension,['10.1097/HJH.0000000000002553']
1376,32650347,Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose.,"BACKGROUND


This study evaluated the impact of power setting and proton pump inhibitor (PPI) dose on efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). METHODS : 71 patients were randomized to APC with power set at 90 W or 60 W followed by 120 mg or 40 mg omeprazole. The primary outcome was the rate of complete (endoscopic and histologic) ablation of BE at 6 weeks. Secondary outcomes included safety and long-term efficacy. RESULTS : Complete ablation rate in the 90 W/120 mg, 90 W/40 mg, and 60 W/120 mg groups was 78 % (18/23; 95 % confidence interval [CI] 61-95), 60 % (15/25; 95 %CI 41-79), 74 % (17/23; 95 %CI 56-92), respectively, at 6 weeks and 70 % (16/23; 95 %CI 51-88), 52 % (13/25; 95 %CI 32-72), and 65 % (15/23; 95 %CI 46-85) at 2 years post-treatment (differences not significant). Additional APC was required in 28 patients (23 residual and 5 recurrent BE). At median follow-up of 108 months, 66/71 patients (93 %; 95 %CI 87-99) maintained complete ablation. No high-grade dysplasia or adenocarcinoma developed. Overall, adverse events (97 % mild) did not differ significantly between groups. Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001). One patient had esophageal perforation and two developed stenosis.
CONCLUSIONS


APC power setting and PPI dose did not impact efficacy and safety of BE ablation. Complete ablation of BE with LGD was durable in > 90 % of patients, without any evidence of neoplasia progression in the long term.",2020,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[""Barrett's esophagus with low-grade dysplasia"", ""Barrett's esophagus (BE) with low-grade dysplasia (LGD"", '28 patients (23 residual and 5 recurrent BE', '71 patients']","['omeprazole', 'Argon plasma coagulation', 'power setting and proton pump inhibitor (PPI', 'argon plasma coagulation (APC']","['Overall, adverse events', 'neoplasia progression', 'esophageal perforation', 'Chest pain/discomfort', 'rate of complete (endoscopic and histologic) ablation of BE', 'stenosis', 'Complete ablation rate', 'safety and long-term efficacy']","[{'cui': 'C1334414', 'cui_str': 'Barretts esophagus with low grade dysplasia'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0014860', 'cui_str': 'Perforation of esophagus'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",71.0,0.245348,Chest pain/discomfort was more frequent in patients receiving 90 W vs. 60 W power ( P  < 0.001).,"[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wronska', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Polkowski', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Orlowska', 'Affiliation': 'Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mroz', 'Affiliation': 'Department of Pathomorphology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Wieszczy', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Regula', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland.'}]",Endoscopy,['10.1055/a-1203-5930']
1377,32653074,"Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study.","BACKGROUND


Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2 -adrenoceptor agonist (ICS-LABA) combinations might benefit from the addition of a long-acting muscarinic receptor antagonist. The aim of the IRIDIUM study was to assess the efficacy and safety of a once-daily, single-inhaler combination of mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY) versus ICS-LABA in patients with inadequately controlled asthma.
METHODS


In this 52-week, double-blind, double-dummy, parallel-group, active-controlled phase 3 study, patients were recruited from 415 sites across 41 countries. Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included. Enrolled patients were randomly assigned (1:1:1:1:1) via interactive response technology to receive medium-dose or high-dose MF-IND-GLY (80 μg, 150 μg, 50 μg; 160 μg, 150 μg, 50 μg) or MF-IND (160 μg, 150 μg; 320 μg, 150 μg) once daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. The primary outcome was change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND at week 26 in patients in the full analysis set, analysed by means of a mixed model for repeated measures. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02571777, and is completed.
FINDINGS


Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened were randomly assigned (medium-dose MF-IND-GLY, n=620; high-dose MF-IND-GLY, n=619; medium-dose MF-IND, n=617; high-dose MF-IND, n=618; high-dose FLU-SAL, n=618). 2747 (88·8%) patients completed the 52-week treatment and 321 (10·4%) started but discontinued study treatment prematurely. Medium-dose MF-IND-GLY (treatment difference [Δ] 76 mL [95% CI 41-111]; p<0·001) and high-dose MF-IND-GLY (Δ 65 mL [31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26. Improvements in trough FEV 1  were greater for both medium-dose MF-IND-GLY (99 mL [64-133]; p<0·001) and high-dose MF-IND-GLY (119 mL [85-154]; p<0·001) than for high-dose FLU-SAL at week 26. Overall, the incidence of adverse events was balanced across the treatment groups. Seven deaths were reported (one with medium-dose MF-IND-GLY, two with high-dose MF-IND-GLY, and four with high-dose MF-IND) during the study; none of these deaths was considered by the investigators to be caused by study drugs or other study-related factors.
INTERPRETATION


Once-daily, single-inhaler MF-IND-GLY improved lung function versus ICS-LABA combinations (MF-IND and FLU-SAL) in patients with inadequately controlled asthma. The safety profile was similar across treatment groups. MF-IND-GLY therefore constitutes a good treatment option in these patients.
FUNDING


Novartis Pharmaceuticals.",2020,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"['2747', 'Between Dec 8, 2015, and Jun 14, 2019, 3092 of 4851 patients screened', 'Patients with asthma who are inadequately controlled on inhaled corticosteroid-long-acting β 2', 'Patients aged 18 to 75 years with symptomatic asthma despite treatment with medium-dose or high-dose ICS-LABA, at least one exacerbation in the previous year, and a percentage of predicted FEV 1  of less than 80% were included', 'patients with inadequately controlled asthma (IRIDIUM', 'patients with inadequately controlled asthma', 'patients were recruited from 415 sites across 41 countries']","['Medium-dose MF-IND-GLY', 'interactive response technology to receive medium-dose or high-dose MF-IND-GLY', 'adrenoceptor agonist (ICS-LABA', 'MF-IND', 'daily via Breezhaler, or high-dose fluticasone-salmeterol (FLU-SAL', 'mometasone furoate, indacaterol acetate, and glycopyrronium bromide (MF-IND-GLY', 'ICS-LABA combinations (MF-IND and FLU-SAL', 'mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol', 'ICS-LABA']","['Safety', 'superior improvement in trough FEV', 'change from baseline in trough FEV 1  with MF-IND-GLY versus MF-IND', 'safety profile', 'efficacy and safety', 'adverse events']","[{'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022071', 'cui_str': 'Iridium'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1.0,0.468901,[31-99]; p<0·001) showed superior improvement in trough FEV 1  versus corresponding doses of MF-IND at week 26.,"[{'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology, University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lavecchia', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30190-9']
1378,32653075,"Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study.","BACKGROUND


Fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and long-acting β 2 -adrenoceptor agonists (LABA) are considered safe and efficacious in asthma management. Most available FDCs require twice-daily dosing to achieve optimum therapeutic effect. The objective of the PALLADIUM study was to assess the efficacy and safety of once-daily FDC of mometasone furoate plus indacaterol acetate (MF-IND) versus mometasone furoate (MF) monotherapy in patients with inadequately controlled asthma.
METHODS


This 52-week, double-blind, triple-dummy, parallel-group, phase 3 study recruited patients from 316 centres across 24 countries. Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included. A history of asthma exacerbations was not a study requirement. Participants were randomily assigned (1:1:1:1:1) via interactive response technology to receive one of the following treatments for 52 weeks: high-dose MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus. Participants received placebo via inhalation through the Breezhaler, Twisthaler, or Diskus devices in the mornings and evenings, as appropriate. The primary endpoint was improvement in trough FEV 1  with high-dose and medium-dose MF-IND versus respective MF doses from baseline at 26 weeks, analysed in the full analysis set by means of a mixed model for repeated measures. High-dose MF-IND once daily was compared with high-dose FLU-SAL twice daily for non-inferiority on improving trough FEV 1  at week 26 with a margin of -90 mL using mixed model for repeated measures as one of the secondary endpoints. Safety was assessed in all patients who had received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02554786, and is completed.
FINDINGS


Between Dec 29, 2015, and May 4, 2018, 2216 patients were randomly assigned (high-dose MF-IND, n=445; medium-dose MF-IND, n=439; high-dose MF, n=442; medium-dose MF, n=444; high-dose FLU-SAL, n=446), of which 1973 (89·0%) completed the study treatment and 234 (10·6%) prematurely discontinued study treatment. High-dose MF-IND (treatment difference [Δ] 132 mL [95% CI 88 to 176]; p<0·001) and medium-dose MF-IND (Δ 211 mL [167 to 255]; p<0·001) showed superiority in improving trough FEV 1  over corresponding MF doses from baseline at week 26. High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26 (Δ 36 mL [-7 to 80]; p=0·101). Overall, the incidence of adverse events was similar across the treatment groups.
INTERPRETATION


Once-daily FDC of ICS and LABA (MF-IND) significantly improved lung function over ICS monotherapy (MF) at week 26; high-dose MF-IND was non-inferior to twice-daily combination of ICS and LABA (high-dose FLU-SAL) for improvement in trough FEV 1 . The combination of MF-IND provides a novel once-daily dry powder option for asthma control.
FUNDING


Novartis Pharmaceuticals.",2020,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"['Between Dec 29, 2015, and May 4, 2018', 'patients with inadequately controlled asthma ', 'Patients aged 12 to 75 years with a documented diagnosis of asthma for at least 1 year, percentage of predicted FEV 1  of 50-85%, and an Asthma Control Questionnaire 7 score of at least 1·5 despite treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were included', 'patients who had received at least one dose of study drug', '2216 patients', '3 study recruited patients from 316 centres across 24 countries', 'patients with inadequately controlled asthma']","['mometasone furoate plus indacaterol acetate (MF-IND', 'mometasone furoate (MF) monotherapy', 'MF-IND (320 μg, 150 μg) or medium-dose MF-IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate-salmeterol xinafoate (FLU-SAL; 500 μg, 50 μg) twice daily via Diskus', 'mometasone plus indacaterol versus mometasone', 'inhaled corticosteroids (ICS) and long-acting', 'fluticasone plus salmeterol', 'adrenoceptor agonists (LABA', 'placebo']","['Safety', 'trough FEV 1  with high-dose and medium-dose MF-IND', 'efficacy and safety', 'superiority in improving trough FEV', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1622832', 'cui_str': 'Fluticasone Propionate-Salmeterol Xinafoate Drug Combination'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2216.0,0.644787,High-dose MF-IND was non-inferior to high-dose FLU-SAL in improving trough FEV 1  from baseline at week 26,"[{'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: richard.vanzyl-smit@uct.ac.za.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Leipzig, Germany; POIS Leipzig, Leipzig, Germany.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Gon', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Noga', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Berlin, Germany.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Richard', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'de Los Reyes', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Pethe', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, US.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30178-8']
1379,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
1380,32651286,"A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis.","OBJECTIVE


To evaluate efficacy, safety, and tolerability of laquinimod in patients with primary progressive multiple sclerosis (PPMS).
METHODS


In the randomized, double-blind, placebo-controlled, phase 2 study, ARPEGGIO (A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations in MRI and Clinical Outcomes), eligible patients with PPMS were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 mg or 1.5 mg or matching placebo. Percentage brain volume change (PBVC; primary endpoint) from baseline to week 48 was assessed by MRI. Secondary and exploratory endpoints included clinical and MRI measures. Efficacy endpoints were evaluated using a predefined, hierarchical statistical testing procedure. Safety was monitored throughout the study. The laquinimod 1.5 mg dose arm was discontinued on January 1, 2016, due to findings of cardiovascular events.
RESULTS


A total of 374 patients were randomized to laquinimod 0.6 mg (n = 139) or 1.5 mg (n = 95) or placebo (n = 140). ARPEGGIO did not meet the primary endpoint of significant treatment effect with laquinimod 0.6 mg vs placebo on PBVC from baseline to week 48 (adjusted mean difference = 0.016%,  p  = 0.903). Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001). Incidence of adverse events was higher among patients treated with laquinimod 0.6 mg (83%) vs laquinimod 1.5 mg (66%) and placebo (78%).
CONCLUSIONS


Laquinimod 0.6 mg did not demonstrate a statistically significant effect on brain volume loss in PPMS at week 48.
CLINICALTRIALSGOV IDENTIFIER


NCT02284568.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, although well tolerated, laquinimod 0.6 mg did not demonstrate a significant treatment effect on PBVC in patients with PPMS.",2020,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","['primary progressive multiple sclerosis', 'patients with primary progressive multiple sclerosis (PPMS', '374 patients', 'eligible PPMS patients']","['Placebo', 'laquinimod 0.6 mg or 1.5 mg or matching placebo', 'Laquinimod', 'laquinimod', 'placebo']","['Safety', 'number of new T2 brain lesions', 'clinical and MRI measures', 'brain volume loss', 'Percentage brain volume change (PBVC', 'efficacy, safety, and tolerability', 'Incidence of adverse events', 'PBVC']","[{'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1260208', 'cui_str': 'laquinimod'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",374.0,0.695841,"Laquinimod 0.6 mg reduced the number of new T2 brain lesions at week 48 (risk ratio = 0.4; 95% confidence interval, 0.26-0.69;  p  = 0.001).","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK. g.giovannoni@qmul.ac.uk.""}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Steinerman', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Tansy', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Krieger', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pia Sormani', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': ""From Barts and The London School of Medicine and Dentistry (G.G.), Blizard Institute, Queen Mary University of London, UK; Teva Pharmaceuticals R&D (V.K.), Teva Pharmaceutical Industries (T.L.), Great Valley, PA; Department of Neurology, Medical Faculty (V.K., H.-P.H.), Heinrich-Heine Universität Düsseldorf, Germany; Teva Pharmaceutical Industries (J.R.S., A.P.T.), Malvern, PA; Corinne Goldsmith Dickinson Center for Multiple Sclerosis (S.K.) and Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Departments of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Maternal and Child Health and Center of Excellence for Biomedical Research (A.U.) and Department of Health Sciences (M.P.S.), University of Genoa; Ospedale Policlinico San Martino-IRCCS (A.U.), Genoa, Italy; Department of Neurology (B.M.J.U.), MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands; Division of Neurology (X.M.), University of Toronto/MS Centre St Michael's Hospital, Canada; Neurology-Neuroimmunology Department and Neurorehabilitation Unit (X.M.), Multiple Sclerosis Centre of Catalonia; Department of Neurology (X.M.), Hospital Universitari de la Vall d'Hebron, Barcelona, Spain; Weill Institute for Neurosciences (B.A.C.C.), Department of Neurology, University of California San Francisco; Radiology & Nuclear Medicine (F.L.), VU University Medical Center, Amsterdam, the Netherlands; and UCL Institutes of Neurology and Healthcare Engineering (F.B.), London, UK.""}]",Neurology,['10.1212/WNL.0000000000010284']
1381,32650683,"Antithymocyte Globulin for Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies: A Multicenter, Open-Label, Randomized Controlled Study.","PURPOSE


The role of antithymocyte globulin (ATG) in preventing acute graft-versus-host disease (aGVHD) after HLA-matched sibling donor transplantation (MSDT) is still controversial.
PATIENTS AND METHODS


We performed a prospective, multicenter, open-label, randomized controlled trial (RCT) across 23 transplantation centers in China. Patients ages 40-60 years with standard-risk hematologic malignancies with an HLA-matched sibling donor were randomly assigned to an ATG group (4.5 mg/kg thymoglobulin plus cyclosporine [CsA], methotrexate [MTX], and mycophenolate mofetil [MMF]) and a control group (CsA, MTX, and MMF). The primary end point of this study was grade 2-4 aGVHD on day 100.
RESULTS


From November 2013 to April 2018, 263 patients were enrolled. The cumulative incidence rate of grade 2-4 aGVHD was significantly reduced in the ATG group (13.7%; 95% CI, 13.5% to 13.9%) compared with the control group (27.0%; 95% CI, 26.7% to 27.3%;  P  = .007). The ATG group had significantly lower incidences of 2-year overall chronic GVHD (27.9% [95% CI, 27.6% to 28.2%]  v  52.5% [95% CI, 52.1% to 52.9%];  P  < .001) and 2-year extensive chronic GVHD (8.5% [95% CI, 8.4% to 8.6%]  v  23.2% [95% CI, 22.9% to 23.5%];  P  = .029) than the control group. There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival. Three-year GVHD relapse-free survival was significantly improved in the ATG group (38.7%; 95% CI, 29.9% to 47.5%) compared with the control group (24.5%; 95% CI, 16.9% to 32.1%;  P  = .003).
CONCLUSION


Our study is the first prospective RCT in our knowledge to demonstrate that ATG can effectively decrease the incidence of aGVHD after MSDT in the CsA era without affecting the CIR or NRM.",2020,"There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival.","['Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies', '23 transplantation centers in China', 'Patients ages 40-60 years with standard-risk hematologic malignancies with an HLA-matched sibling donor', 'From November 2013 to April 2018, 263 patients were enrolled']","['control group (CsA, MTX, and MMF', 'Antithymocyte Globulin', 'antithymocyte globulin (ATG', 'HLA-matched sibling donor transplantation (MSDT', 'ATG group (4.5 mg/kg thymoglobulin plus cyclosporine [CsA], methotrexate [MTX], and mycophenolate mofetil [MMF']","['GVHD relapse-free survival', '2-year extensive chronic GVHD', 'cumulative incidence rate of grade 2-4 aGVHD', 'cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival', '2-year overall chronic GVHD']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0730920', 'cui_str': 'Thymoglobulin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}]",263.0,0.178938,"There were no differences between the ATG and control groups with regard to cytomegalovirus reactivation, Epstein-Barr virus reactivation, 3-year nonrelapse mortality (NRM), 3-year cumulative incidence of relapse (CIR), 3-year overall survival, or 3-year leukemia-free survival.","[{'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}, {'ForeName': 'De-Pei', 'Initials': 'DP', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yong-Rong', 'Initials': 'YR', 'LastName': 'Lai', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Qi-Fa', 'Initials': 'QF', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu-Qian', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory for Medical Genomics, Department of Hematology, Shanghai Institute of Hematology, and Collaborative Innovation Center of Hematology, Rui-Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital Affiliated With Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shun-Qing', 'Initials': 'SQ', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Dong-Jun', 'Initials': 'DJ', 'LastName': 'Lin', 'Affiliation': 'Third Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Ren', 'Affiliation': 'Department of Hematology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Fang-Pin', 'Initials': 'FP', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Xinqiao Hospital Affiliated to Third Military Medical University, Chongqing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, China.'}, {'ForeName': 'Yong-Ping', 'Initials': 'YP', 'LastName': 'Song', 'Affiliation': 'The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jian-Da', 'Initials': 'JD', 'LastName': 'Hu', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying-Min', 'Initials': 'YM', 'LastName': 'Liang', 'Affiliation': ""Tangdu Hospital Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Jing-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Southern Theater General Hospital of the Chinese People's Liberation Army, Guangzhou, China.""}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': ""Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, and Peking-Tsinghua Center for Life Sciences, Beijing, China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00150']
1382,32654156,Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis.,"INTRODUCTION


Hereditary transthyretin-mediated amyloidosis (hATTR) manifests as multisystem dysfunction, including progressive polyneuropathy. Inotersen, an antisense oligonucleotide, improved the course of neuropathic impairment in patients with hATTR in the pivotal NEURO-TTR study (NCT01737398). To determine inotersen's impact on symptoms and patients' neuropathy experience, we performed a post hoc analysis of the Neuropathy Symptoms and Change (NSC) score.
METHODS


Stage 1 or 2 hATTR patients were randomized to receive weekly subcutaneous inotersen or placebo for 65 weeks. NSC score was assessed at baseline and 35 and 66 weeks.
RESULTS


At 66 weeks, inotersen-treated patients had symptom stabilization as compared with worsening in patients receiving placebo, based on total NSC score. There were also improvements in the subdomains of muscle weakness, sensory, pain, and autonomic symptoms, and for various individual items.
DISCUSSION


Inotersen treatment stabilized neuropathy symptoms, including autonomic symptoms, in patients with hATTR according to NSC score. Thus, the NSC may be an effective measure to assess neuropathy progression and patients' neuropathy experience in clinical practice.",2020,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","['patients with hATTR based on the NSC score', 'Stage 1/2 hATTR patients', 'Hereditary Transthyretin Amyloidosis']","['subcutaneous inotersen or placebo', 'placebo']","['NSC score', 'Neuropathy Symptoms and Change (NSC) score', 'muscle weakness, sensory, pain, and autonomic symptoms', 'neuropathic impairment', 'Neuropathy Symptom and Change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0554384,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Department of Neurosciences, Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'Department of Neurology, Federal University of Rio de Janeiro, University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Department of Peripheral Neuropathy, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Department of Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc, San Diego, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27023']
1383,32654212,mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis.,"INTRODUCTION


Inotersen, an antisense oligonucleotide inhibitor of transthyretin (TTR) protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score (NIS) +7 neurophysiologic tests (mNIS+7) in patients with hereditary TTR-mediated amyloidosis (hATTR) with polyneuropathy. This analysis assessed the mNIS+7 components by anatomic location and the lower limb function (LLF) test.
METHODS


Adults with hATTR in the NEURO-TTR trial (NCT01737398) were randomly assigned to receive weekly doses of subcutaneous inotersen 300 mg or placebo for 65 weeks. The mNIS+7 and LLF were assessed at 35 and 66 weeks.
RESULTS


All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation) and the LLF showed significant efficacy in patients receiving inotersen versus placebo; however, NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate during deep breathing did not show significant effects.
DISCUSSION


The results of this analysis reinforce the beneficial effect of inotersen on slowing neuropathy progression in patients with hATTR polyneuropathy.",2020,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","['Adults with hATTR', 'patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy', 'patients with hATTR polyneuropathy']","['subcutaneous inotersen 300 mg or placebo', 'placebo']","['All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation', 'mNIS+7 and LLF', 'Mnis+7 And Lower Limb Function', 'NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0206247', 'cui_str': 'Polyneuropathy in amyloidosis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504824', 'cui_str': 'SLC5A5 protein, human'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",,0.124471,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc., San Diego, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27022']
1384,32653895,Optimizing behavior therapy for youth with Tourette's disorder.,"Tourette's Disorder (TD) is characterized by tics that cause distress and impairment. While treatment guidelines recommend behavior therapy as a first-line intervention, patients with TD may exhibit limited therapeutic response. Given the need to improve treatment outcomes, this study examined the efficacy of augmenting behavior therapy with D-cycloserine (DCS) to reduce tic severity in a placebo-controlled quick-win/fast-fail trial. Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity. Youth were randomly assigned to receive a single session of habit reversal training (HRT) augmented by either 50 mg of DCS or placebo. Two bothersome tics on the Hopkins Motor/Vocal Tic Scale (HM/VTS) were targeted for treatment during HRT. One week after the HRT session, youth completed a posttreatment assessment to evaluate change in the severity of bothersome tics. All assessments were completed by independent evaluators masked to treatment group. There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder. Follow-up comparisons revealed small group differences at the treatment visit (d = 0.27), with the DCS group exhibiting slightly greater severity for targeted tics. There was a large group difference at posttreatment, in which the DCS group exhibited lower severity for targeted tics (d = 1.30, p < 0.001) relative to the placebo group. Findings demonstrate the preliminary enhancement of tic severity reductions by augmenting HRT with DCS compared with placebo augmentation.",2020,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[""youth with Tourette's disorder"", 'Twenty youth with TD completed a baseline assessment to characterize tic severity, premonitory urges, medical history, and psychiatric comorbidity']","['placebo', 'habit reversal training (HRT) augmented by either 50\u2009mg of DCS or placebo', 'DCS', 'behavior therapy with D-cycloserine (DCS']","['Hopkins Motor/Vocal Tic Scale (HM/VTS', 'targeted tics', 'severity of bothersome tics']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0040517', 'cui_str': ""Gilles de la Tourette's syndrome""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0751901', 'cui_str': 'Tic, Vocal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.322576,"There was a Treatment Group by Time Interaction in favor of DCS-augmented HRT (p < 0.01), controlling for baseline tic severity, tic medication, and attention deficit hyperactivity disorder.","[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. jfmcguire@jhmi.edu.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Ginder', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kesley', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Joey Ka-Yee', 'Initials': 'JK', 'LastName': 'Essoe', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0762-4']
1385,32655007,Metabolomics Analysis of Aspirin's Effects in Human Colon Tissue and Associations with Adenoma Risk.,"Although substantial evidence supports aspirin's efficacy in colorectal cancer chemoprevention, key molecular mechanisms are uncertain. An untargeted metabolomics approach with high-resolution mass spectrometry was used to elucidate metabolic effects of aspirin treatment in human colon tissue. We measured 10,269 metabolic features in normal mucosal biopsies collected at colonoscopy after approximately 3 years of randomized treatment with placebo, 81 or 325 mg/day aspirin from 325 participants in the Aspirin/Folate Polyp Prevention Study. Linear regression was used to identify aspirin-associated metabolic features and network analysis was used to identify pathways and predict metabolite identities. Poisson regression was used to examine metabolic features associations with colorectal adenoma risk. We detected 471 aspirin-associated metabolic features. Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism). Among aspirin-associated metabolic features, we discovered three that were associated with adenoma risk and could contribute to the chemopreventive effect of aspirin treatment, and which have also previously been associated with colorectal cancer: creatinine, glycerol 3-phosphate, and linoleate. The last two of these are in the glycerophospholipid metabolism pathway, which was associated with 81 mg aspirin treatment and provides precursors for the synthesis of eicosanoids from arachidonic acid upstream of cyclooxygenase inhibition by aspirin. Conversely, carnitine shuttle metabolites were increased with aspirin treatment and associated with increased adenoma risk. Thus, our untargeted metabolomics approach has identified novel metabolites and pathways that may underlie the effects of aspirin during early colorectal carcinogenesis.",2020,"Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism).","['human colon tissue', 'Human Colon Tissue and Associations with Adenoma Risk']","['placebo, 81 mg/day or 325 mg/day aspirin', 'Aspirin', 'aspirin']","['adenoma risk', 'carnitine shuttle metabolites']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",10269.0,0.0361142,"Aside from the carnitine shuttle, aspirin-associated metabolic pathways were largely distinct for 81 mg aspirin (e.g., pyrimidine metabolism) and 325 mg (e.g., arachidonic acid metabolism).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire. Elizabeth.L.Barry@dartmouth.edu.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University and Winship Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Uppal', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Dean P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0014']
1386,32653333,Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.,"STUDY OBJECTIVE


Acute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial.
METHODS


Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded.
RESULTS


Among 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%).
CONCLUSION


Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.",2020,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","['Acute Urticaria', '262 enrolled patients', 'Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous']","['antihistamine', 'intravenous cetirizine 10 mg or intravenous diphenhydramine', 'diphenhydramine', 'cetirizine', 'Intravenous Cetirizine', 'Diphenhydramine']","['baseline sedation score', 'adverse event rate', 'Frequency of sedation and anticholinergic adverse effects', '2-hour pruritus score change', '2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers', 'mean time spent']","[{'cui': 'C0234935', 'cui_str': 'Acute urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1551285', 'cui_str': 'Urgent care clinic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",262.0,0.0952898,"Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.","[{'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: benjamin.abella@pennmedicine.upenn.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Berger', 'Affiliation': 'Allergy and Asthma Associates of Southern California, Mission Viejo, CA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Blaiss', 'Affiliation': 'Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta, GA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Stiell', 'Affiliation': 'Department of Emergency Medicine, University of Ottawa and Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Herres', 'Affiliation': 'Department of Emergency Medicine, Einstein Healthcare Network, Philadelphia, PA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Moellman', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Suner', 'Affiliation': 'Department of Emergency Medicine, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kessler', 'Affiliation': 'Department of Emergency Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Klausner', 'Affiliation': 'Department of Emergency Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'Department of Emergency Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'TerSera Therapeutics, Deerfield, IL.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.05.025']
1387,32654022,Two different therapies for the middle turbinate during endoscopic sinus surgery for chronic rhinosinusitis.,"BACKGROUND


The population of patients with chronic rhinosinusitis (CRS) has greatly increased. When medical treatment fails, endoscopic sinus surgery (ESS) is considered. In the present study, the value of two different therapies for the middle turbinate to optimize surgical outcomes was observed. Our objective was to determine a better management approach for the middle turbinate to effectively preserve the middle turbinate mucosa and function and avoid complications following ESS, such as nasal adhesions on the operative side.
METHODS


Thirty patients [group A; treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy during complete ESS for CRS were observed. Nasal cavities were compared using perioperative sinus endoscopy (POSE) and Lund-Kennedy (LKES) scores preoperatively and at 15 days, 2 months and 1 year after ESS.
RESULTS


Preoperatively, the POSE (8.83 ± 3.81 vs 9.15 ± 3.85, p = 0.45, for groups A and B, respectively) and LKES (4.23 ± 0.74 vs 4.13 ± 0.70, p = 0.34) scores were similar between groups. In group A, anterior adhesions were reported on six sides of the middle turbinate, severe adhesions were observed on two sides, mild adhesions were observed on one side, and adhesions occurred on two sides during follow-up. After retreatment, adhesions were still observed on two sides at 1 year. In group B, only mild anterior adhesions were observed on two sides. There was no difference between group A and group B at 15 days, and the POSE (4.31 ± 1.19 vs 4.07 ± 1.42, p = 0.11, for groups A and B, respectively) and LKES (3.35 ± 0.82 vs 3.33 ± 0.90, p = 0.91) scores were similar between groups. There was no significant difference in LKES (0.22 ± 0.49 vs 0.10 ± 0.35, p = 0.15) scores at 1 year between the two groups. There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
CONCLUSIONS


Our results show that middle turbinate preservation and combined therapy was a better ESS method for CRS. Multiapproach middle conchoplasty, which is predominately a submucoperiosteal surgery, can preserve more of the mucosa and functions of the middle turbinate. Unlike the single-approach middle conchoplasty described in previous research, multiapproach middle conchoplasty is achieved by combining a three-step surgical procedure (""surgery, packing and removal"") with ""cocktail-style"" postoperative packing and removal.",2020,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","['patients with chronic rhinosinusitis (CRS', 'chronic rhinosinusitis', 'Thirty patients [group A']","['endoscopic sinus surgery', 'treated prior to 2015 (primary surgery)] undergoing resection of the middle turbinate bone during complete ESS for CRS and 30 patients [group B; treated after 2015 (later surgery)] undergoing middle turbinate preservation and multiapproach therapy', 'endoscopic sinus surgery (ESS']","['nasal cavities', 'endoscopic appearance', 'LKES', 'LKES scores', 'severe adhesions', 'mild anterior adhesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225435', 'cui_str': 'Middle nasal turbinate structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",,0.0319759,"There was a significant difference in the nasal cavities between group A and group B at 2 months and 1 year, where group B showed a better endoscopic appearance than group A at 2 months and 1 year (with POSE scores of 3.48 ± 0.83 vs 2.43 ± 1.38 (p = 0.00) and LKES scores of 1.35 ± 0.86 vs 1.15 ± 0.90 (p = 0.02) at 2 months for groups A and B, respectively, and POSE scores of 1.00 ± 0.96 vs 0.62 ± 0.87 (p = 0.001) at 1 year for groups A and B, respectively).
","[{'ForeName': 'Meichan', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. zhumeichan@126.com.""}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China. yungyi@188.com.""}, {'ForeName': 'Huicheng', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Yunwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}, {'ForeName': 'Guojie', 'Initials': 'G', 'LastName': 'Tan', 'Affiliation': ""Department of Otorhinolaryngology, Guangzhou Twelfth People's Hospital (Guangzhou Otolarynology-Head and Neck Surgery Hospital), Tianhe District, No 1. Tianqiang Road, Guangzhou, 510620, Guangdong, China.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06184-4']
1388,32648430,Editorial Comment: Randomised Trial of Adjuvant Radiotherapy Following Radical Pros-tatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension.,,2020,,['Prostate Cancer Patients with Posi-tive Margins or Extracapsular Extension'],"['Adjuvant Radiotherapy Following Radical Pros', 'tatectomy Versus Radical Prostatectomy Alone']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C3899187', 'cui_str': 'Extracapsular Extension'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]",[],,0.0471933,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.05.10']
1389,32659313,"Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results.","BACKGROUND


The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg).
OBJECTIVE


We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study.
METHODS


Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment.
RESULTS


Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%).
CONCLUSIONS


These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.",2020,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","['peanut-allergic children aged 4-11 years', '198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36', '18 subjects underwent an', 'Subjects who completed PEPITES were offered enrollment in PEOPLE', 'Peanut Allergy in Children']","['Epicutaneous Immunotherapy', 'epicutaneous immunotherapy (EPIT™', 'optional SU', 'placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment']","['Compliance', 'Median cumulative reactive dose', 'Local patch-site skin reactions', 'ED', 'interim safety and efficacy']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",213.0,0.147914,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo. Electronic address: david.fleischer@childrenscolorado.org.""}, {'ForeName': 'Wayne G', 'Initials': 'WG', 'LastName': 'Shreffler', 'Affiliation': 'Food Allergy Center, Departments of Pediatrics and Medicine, Massachusetts General Hospital, Boston, Mass.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, Australia; DBV Technologies, Montrouge, France.""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ""DBV Technologies, Montrouge, France; Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Anvari', 'Affiliation': ""Section of Immunology, Allergy and Rheumatology, Texas Children's Hospital, Houston, Tex; Department of Pediatrics, Allergy and Immunology Section, Baylor College of Medicine, Houston, Tex.""}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': ""Assa'ad"", 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Bird', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Brown-Whitehorn', 'Affiliation': ""Division of Allergy and Immunology, The Children's Hospital of Philadelphia, Philadelphia, Pa; Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa.""}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': ""Paediatric Allergy Department, Our Lady's Children's Hospital, Dublin, Ireland.""}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Cheema', 'Affiliation': 'Cheema Research Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, Calif.'}, {'ForeName': 'Hey Jin', 'Initials': 'HJ', 'LastName': 'Chong', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, Allergy and Immunology Section, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Ford', 'Affiliation': ""Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': ""Service d'Allergie et Immunologie, Département de Médecine, Centre Hospitalier Universitaire de Québec, Quebec, Canada.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo.""}, {'ForeName': ""Jonathan O'B"", 'Initials': 'JO', 'LastName': 'Hourihane', 'Affiliation': 'Paediatrics and Child Health, INFANT Centre and Health Research Board-Clinical Research Facility, University College Cork, Cork, Ireland; Department of Paediatrics, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Pediatrics - Allergy and Immunology, University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lange', 'Affiliation': 'Department of Pediatrics, St. Marien Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Lanser', 'Affiliation': 'Division of Pediatric Allergy and Clinical Immunology, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': ""Department of Pediatrics, University of California San Diego, San Diego, Calif; Rady Children's Hospital, San Diego, Calif.""}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mahler', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maronna', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': ""Hassenfeld Children's Hospital at New York University Langone Health, New York, NY; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.""}, {'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Oriel', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': ""Perth Children's Hospital, Nedlands, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petroni', 'Affiliation': 'Seattle Allergy and Asthma Research Institute, Seattle, Wash.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Allergy and Immunology Division, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': ""Perth Children's Hospital, Nedlands, Australia; Department of Paediatrics, The University of Western Australia School of Medicine, Perth, Australia.""}, {'ForeName': 'Lynda C', 'Initials': 'LC', 'LastName': 'Schneider', 'Affiliation': ""Division of Immunology, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'School of Medical Science, Griffith University, Southport, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Staab', 'Affiliation': 'Department of Pediatrics, Division of Pulmonology, Immunology and Critical Care Medicine, Charité-Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Division of Allergy and Clinical Immunology, Johns Hopkins Hospital, Baltimore, Md.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, University of Ottawa Medical School, Ottawa, Ontario, Canada.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lambert', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Peillon', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Bois', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France; Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.028']
1390,32659637,Cost and cost-effectiveness of three strategies for implementing motivational interviewing for substance misuse on medical inpatient units.,"BACKGROUND


This study conducted cost and cost-effectiveness analyses of three strategies for implementing motivational interviewing for substance misuse on general medical inpatient units: workshop, apprenticeship, and consult.
METHODS


The economic analyses were conducted prospectively alongside a type 3 hybrid effectiveness-implementation randomized trial comprising 38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts. The trial took place in a university affiliated teaching hospital in New Haven, CT, USA. After completing a 1-day workshop on motivational interviewing, providers were randomized to conditions. The primary outcome measure was the number of study-eligible patients who received a motivational interview. The economic analyses included the costs of both start-up and on-going activities in each condition. Incremental cost-effectiveness ratios were used to determine cost effectiveness. Results are presented from the healthcare provider (i.e., hospital) perspective in 2018 US dollars.
RESULTS


The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively. Workshop and apprenticeship were extended dominated by the combination of consult and doing nothing. Doing nothing is cost effective when the willingness-to-pay for an additional patient receiving a motivational interview is less than $185.65, and consult is cost-effective when the willingness-to-pay for an additional patient receiving a motivational interview is greater than $185.65.
CONCLUSIONS


Given that typical reimbursements for brief intervention services for substance misuse are $35-$65, none of the three implementation strategies is likely to be economically viable from the healthcare provider perspective.",2020,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","['substance misuse on medical inpatient units', '38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts', 'university affiliated teaching hospital in New Haven, CT, USA']",['implementing motivational interviewing'],"['Cost and cost-effectiveness', 'Incremental cost-effectiveness ratios', 'total cost per patient receiving a motivational interview']","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",38.0,0.0294972,"The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'The University of Texas at Austin, Lyndon B. Johnson School of Public Affairs, Sid Richardson Hall, Unit 3, Austin, TX, 78712, USA. Electronic address: tolmstead@austin.utexas.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; Yale School of Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, 333 Cedar Street, New Haven, CT, 06510, USA; Yale School of Epidemiology and Public Health Division of Chronic Disease, 60 College Street, New Haven, CT, 06520, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 300 George Street, Suite 901, New Haven, CT, 06520, USA; VA Connecticut Healthcare System, Psychology Service, 950 Campbell Avenue (116B), West Haven, CT, 06516, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108156']
1391,32660708,Repeteability of Circulating Eosinophil Measures and Inhaled Corticosteroids Effect in Bronchiectasis. A Post Hoc Analysis of a Randomized Clinical Trial.,,2020,,['Bronchiectasis'],[],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}]",[],[],,0.0809084,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.06.005']
1392,32660857,[Evaluation of the use of a simulation software in the learning of cardiopulmonary auscultation in undergraduate medical students].,"INTRODUCTION


Medsounds™ software allows to create an auscultation learning platform, by providing real pre-recorded cardiopulmonary sounds on virtual chests. The study aimed at comparing the skills in cardiopulmonary auscultation between students who benefited from this platform and students who did not have access to it.
METHODS


A controlled trial was conducted with 2nd year medical students randomised into three groups. Groups A, B and C received 10 h of cardiopulmonary clinical training. In addition, group B benefited from an online access to the educative platform, and group C had a demonstration of the platform during their clinical training, then an online access. The main outcome was a 3-point multiple-choice questionnaire based on 2 original case vignettes about the description of cardiopulmonary sounds. The secondary outcome was the faculty exam on high-fidelity cardiopulmonary simulator.
RESULTS


Groups A and B included 127 students, and group C 117. Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01). Students who had a demonstration of the platform before using it performed a better pulmonary examination on high-fidelity simulators.
CONCLUSION


The supervised use of an online auscultation simulation software in addition to the traditional clinical training seems to improve the auscultation performances of undergraduated medical students.",2020,"Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01).","['Groups A and B included 127 students, and group C 117', 'undergraduated medical students', 'undergraduate medical students', 'students who benefited from this platform and students who did not have access to it', 'Students who had a demonstration of the platform before using it performed a better pulmonary examination on high-fidelity simulators']",['simulation software'],"['3-point multiple-choice questionnaire based on 2 original case vignettes about the description of cardiopulmonary sounds', 'faculty exam on high-fidelity cardiopulmonary simulator']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]",127.0,0.0375606,"Students in group C had a significantly higher score than those in group A (1.72/3 versus 1.48/3; p = 0.02), without difference between the groups B and C. Students who actually had a demonstration of the platform and used it at home had a higher score than those who did not use it (1.87 versus 1.51; p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malmartel', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Département de médecine générale Paris Descartes, F-75014 Paris, France. Electronic address: alexandre.malmartel@u-paris.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ecollan', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Département de médecine générale Paris Descartes, F-75014 Paris, France.'}, {'ForeName': 'M-C', 'Initials': 'MC', 'LastName': 'Bories', 'Affiliation': 'Service de chirurgie cardiovasculaire, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, F-75014 Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jablon', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Planquette', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, F-75014 Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ranque', 'Affiliation': 'Faculté de Médecine Paris Descartes, Université de Paris, F-75006 Paris, France; Service de médecine interne, Hôpital Européen Georges-Pompidou, Assistance Publique Hôpitaux de Paris, F-75014 Paris, France.'}]",La Revue de medecine interne,['10.1016/j.revmed.2020.04.012']
1393,32660977,"Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.","OBJECTIVES


SPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.
METHODS


SPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.
RESULTS


A significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.
CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.
TRIAL REGISTRATION NUMBER


NCT03151551.",2020,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","['566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA', 'bionaïve patients with PsA. Patients', 'patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug']","['IXE or ADA', 'conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD', 'IXE', 'ixekizumab (IXE) with adalimumab (ADA', 'ixekizumab versus adalimumab', 'IXE and ADA']","['simultaneous ACR50 and PASI100', 'musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety', 'simultaneous joint and skin improvement', 'IXE efficacy', 'PASI100 responses', 'efficacy and safety', 'ACR50 and PASI100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0954263,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Providence St Joseph Health, Rentton, Washington, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hojnik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Caporali', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, G. Pini Hospital, Milan, Lombardia, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitario Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, Regional University Hospital Centre Tours, Tours, Centre, France.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Gold Coast, Queensland, Australia.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217372']
1394,32673830,Accelerated treatment of endocarditis-The POET II trial: Rationale and design of a randomized controlled trial.,"BACKGROUND


The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients.
OBJECTIVE


The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE.
METHODS


The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization.
CONCLUSIONS


The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.",2020,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","['patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis', 'patients with left-sided IE']","['accelerated (shortened) antibiotic therapy', 'accelerated antibiotic therapy']","['microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis', 'composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6\u202fmonths of randomization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1142550', 'cui_str': 'Native valve endocarditis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.224308,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","[{'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mia Marie', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Bo', 'Initials': 'RB', 'LastName': 'Hasselbalch', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Åkesson', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Department of Infectious Diseases, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Povlsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Müllertz', 'Affiliation': 'Department of Cardiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Christian Ditlev', 'Initials': 'CD', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Ihlemann', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jannik', 'Initials': 'J', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emil Loldrup', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark. Electronic address: Henning.Bundgaard@regionh.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.05.012']
1395,32671687,Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis.,"INTRODUCTION


FPG GOAL was a 24-week, open-label, treat-to-target randomized controlled trial which demonstrated that the optimal self-monitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9-6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of < 7% without increasing the risk of hypoglycemia.
METHODS


For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, ≤ 5.6 mmol/L; level 2, > 5.6 to ≤ 6.1 mmol/L; and level 3, > 6.1 to ≤ 7.0 mmol/L.
RESULTS


At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c < 7% or HbA1c < 7% without hypoglycemia (≤ 3.9 or ≤ 3.0 mmol/L) was significantly higher in FPG levels 1 (p < 0.01) and 2 (p < 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (- 1.77% and - 1.66% vs - 1.34%; both p < 0.001) and 2-h postprandial glucose (- 3.88 mmol/L and - 3.98 mmol/L vs - 3.22 mmol/L; both p < 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449).
CONCLUSIONS


Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels. ClinicalTrials.gov identifier NCT02545842.",2020,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"['Individuals with Type\xa02 Diabetes', '863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved', 'Chinese individuals with type\xa02 diabetes (T2D) using']","['insulin glargine', 'Fasting Glucose Levels']","['FPG levels', 'actual laboratory FPG levels', 'hypoglycemia', '2-h postprandial glucose', 'fasting plasma glucose (FPG) levels', 'FPG and HbA1c levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",863.0,0.0347012,mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels.,"[{'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Minxiang', 'Initials': 'M', 'LastName': 'Lei', 'Affiliation': 'Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yunguang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China. ywying_1010@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01410-1']
1396,32677499,Effects of Simulation Video on Parental Recall of Seizure First Aid: A Quality Improvement Project.,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits. This quality improvement project evaluated if adding a video simulation of seizure first aid improved parental recall. Parents of children with seizures were randomized to standard verbal counseling or video group, which were shown a video simulation of seizure first aid. All families also received a standardized written action plan. Eighty-three patients were randomized from July to October 2018. Overall, 53% of families who received standard counseling accurately recalled seizure first aid compared with 31% in video group (χ 2  = 3.24,  P  = .07). Among families without baseline knowledge of seizure first aid, 43% in the standard counseling group recalled accurately compared with 16% of video group (χ 2  = 4.52,  P  = .03). These results underscore the importance of face-to-face patient education despite the popularity of video-based media. Future Plan-Do-Study-Act cycles will include piloting a hands-on seizure first aid simulation with mannequins.",2020,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","['Parents of children with seizures', 'Eighty-three patients were randomized from July to October 2018']","['Simulation Video', 'standard verbal counseling or video group']",['Parental Recall of Seizure First Aid'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]",83.0,0.0518988,"Many parents of children do not recall anticipatory guidance on acute seizure management, which can lead to unnecessary emergency department visits.","[{'ForeName': 'Xinran Maria', 'Initials': 'XM', 'LastName': 'Xiang', 'Affiliation': '12258Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': '12258Louisiana State University Health Sciences Center, New Orleans, LA, USA.'}]",Journal of child neurology,['10.1177/0883073820939390']
1397,32661909,"Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women.","BACKGROUND AND OBJECTIVES


Advanced estrogen receptor-positive (ER+) breast cancer is currently treated with endocrine therapy. Elacestrant is a novel, nonsteroidal, selective estrogen receptor degrader with complex dose-related ER agonist/antagonist activity that is being developed as a treatment option for ER+ breast cancer.
METHODS


Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004) were conducted to determine its pharmacokinetic and pharmacodynamic profile as well as its safety and maximum tolerated dose.
RESULTS


In total, 140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received placebo). Single-ascending dose and multiple-ascending dose assessments showed that doses up to 1000 mg daily were safe and well tolerated, and the maximum tolerated dose was not reached. Oral administration of elacestrant had an absolute bioavailability of 10% and a mean half-life ranging from 27 to 47 h, reaching steady state after 5-6 days. Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily. The median ratio of elacestrant concentrations in the cerebral spinal fluid vs. plasma was 0.126% (500 mg dose) and 0.205% (200 mg dose). Most adverse events were related to the upper gastrointestinal tract.
CONCLUSIONS


These data demonstrate that elacestrant has good bioavailability when administered orally with a half-life that supports once-daily administration. Engagement of the ER and some ability to cross the blood-brain barrier was demonstrated in addition to an acceptable safety profile.",2020,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"['Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004', 'Healthy Post-Menopausal Women', '140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received']",['placebo'],"['absolute bioavailability', 'median ratio of elacestrant concentrations', 'Mean occupancy of the ER', 'safe and well tolerated']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4.0,0.0994447,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Conlan', 'Affiliation': 'Department of Oncology Clinical Development, Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA. mconlan@radiuspharm.com.'}, {'ForeName': 'Erik F J', 'Initials': 'EFJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Awjm', 'Initials': 'A', 'LastName': 'Glaudemans', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Troy', 'Affiliation': 'Department of Clinical Pharmacology, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00635-3']
1398,32662280,Integrating the Early Start Denver Model into Israeli community autism spectrum disorder preschools: Effectiveness and treatment response predictors.,"LAY ABSTRACT


Early intensive intervention has been shown to significantly affect the development of children with Autism. However, the costly implementation of such interventions limits their wide dissemination in the community. This study examined an integration of a research-supported early intensive intervention model called the Early Start Denver Model into community preschool programs for children with Autism in Israel. Four community preschools implemented the preschool-based Early Start Denver Model and four implemented the existing multidisciplinary developmental intervention which is widely applied in Israeli community preschools for children with autism. Fifty-one children (aged 33-57 months) participated in the study. Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools. Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status. Results showed that, compared to the multidisciplinary developmental intervention group, children in the preschool-based Early Start Denver Model treatment group made greater gains on measures of overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities. Children who had lower autism symptom severity, higher adaptive functioning and better language understanding abilities before taking part in the preschool-based Early Start Denver Model program showed greater improvements following it. This study documents the successful implementation of an intensive early intervention program in pre-existing community preschools, underlining the importance of the integration of research-supported intervention programs into community settings.",2020,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","['children with Autism in Israel', 'children with autism', 'children with Autism', 'Fifty-one children (aged 33-57\u2009months) participated in the study', 'Twenty-six attended the preschool-based Early Start Denver Model preschools and twenty-five attended the multidisciplinary developmental intervention preschools']",['intensive early intervention program'],"['overall cognitive development, language skills, as well as on parent- and teacher-reported adaptive communication and socialization abilities', 'adaptive functioning and better language understanding abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",51.0,0.0150567,"Before the intervention began, groups were comparable on children's age and developmental functioning and on families' socio-economic status.","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Sinai-Gavrilov', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gev', 'Affiliation': 'Bar-Ilan University, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Mor-Snir', 'Affiliation': 'The Association for Children at Risk, Israel.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Golan', 'Affiliation': 'Bar-Ilan University, Israel.'}]",Autism : the international journal of research and practice,['10.1177/1362361320934221']
1399,32663660,"Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.","BACKGROUND


Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.
METHODS/DESIGN


The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).
CONCLUSION


The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.",2020,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","['STEMI patients undergoing pPCI', 'STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure', 'after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction']","['prolonged anticoagulant or matching placebo (no anticoagulation', 'unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin', 'anticoagulation prolongation versus no anticoagulation', 'placebo']","['composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel', 'major bleeding (BARC 3-5', 'ischemic events']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",2856.0,0.600901,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: eva3321@sina.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spaceeye123@126.com.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: guojcmd@126.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: lyjbs2009@yeah.net.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ai', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: aihui0814@126.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: tjmusky@126.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Que', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: quebin@sohu.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhen', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: 13439546840@yeah.net.'}, {'ForeName': 'Jiapeng', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiapeng.lu@fwoxford.org.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spnie@ccmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.06.005']
1400,32669708,The National Lung Matrix Trial of personalized therapy in lung cancer.,"The majority of targeted therapies for non-small-cell lung cancer (NSCLC) are directed against oncogenic drivers that are more prevalent in patients with light exposure to tobacco smoke 1-3 . As this group represents around 20% of all patients with lung cancer, the discovery of stratified medicine options for tobacco-associated NSCLC is a high priority. Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents. Here we report the current outcomes of 19 drug-biomarker cohorts from the ongoing National Lung Matrix Trial, the largest umbrella trial in NSCLC. We use next-generation sequencing to match patients to appropriate targeted therapies on the basis of their tumour genotype. The Bayesian trial design enables outcome data from open cohorts that are still recruiting to be reported alongside data from closed cohorts. Of the 5,467 patients that were screened, 2,007 were molecularly eligible for entry into the trial, and 302 entered the trial to receive genotype-matched therapy-including 14 that re-registered to the trial for a sequential trial drug. Despite pre-clinical data supporting the drug-biomarker combinations, current evidence shows that a limited number of combinations demonstrate clinically relevant benefits, which remain concentrated in patients with lung cancers that are associated with minimal exposure to tobacco smoke.",2020,Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents.,"['lung cancer', '19 drug-biomarker cohorts from the ongoing National Lung Matrix Trial, the largest umbrella trial in NSCLC', 'patients with light exposure to tobacco smoke 1-3 ', 'patients with lung cancers', '5,467 patients that were screened, 2,007 were molecularly eligible for entry into the trial, and 302 entered the trial to receive genotype-matched therapy-including 14 that re-registered\xa0to the trial for a sequential trial drug']",['personalized therapy'],[],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4761125', 'cui_str': 'Exposure to tobacco'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],5467.0,0.0938514,Umbrella trials seek to streamline the investigation of genotype-based treatments by screening tumours for multiple genomic alterations and triaging patients to one of several genotype-matched therapeutic agents.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'Institute of Immunology & Immunotherapy, University of Birmingham, Birmingham, UK. g.middleton@bham.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fletcher', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Summers', 'Affiliation': 'The Christie, Manchester, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Greystoke', 'Affiliation': 'Newcastle University, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Cave', 'Affiliation': 'Southampton University Hospitals NHS Trust, Southampton, UK.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': ""O'Rourke"", 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brewster', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Toy', 'Affiliation': 'Royal Devon and Exeter Foundation NHS Trust, Exeter, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': ""King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dangoor', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Mackean', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Forster', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Wherton', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manita', 'Initials': 'M', 'LastName': 'Mehmi', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Sharpe', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mills', 'Affiliation': 'Cancer Research UK, London, UK.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Cerone', 'Affiliation': 'Cancer Research UK, London, UK.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Yap', 'Affiliation': 'The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas B K', 'Initials': 'TBK', 'LastName': 'Watkins', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Swanton', 'Affiliation': 'The Francis Crick Institute, London, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Billingham', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}]",Nature,['10.1038/s41586-020-2481-8']
1401,32670199,Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Jinlida Granules on Metabolic Syndrome in Patients With Abnormal Glucose Metabolism.,"Background:  Metabolic syndrome (MS) is a powerful risk factor for cardiovascular and cerebrovascular diseases. Although lifestyle intervention reduces several of the symptoms of the syndrome and cardiovascular risks, the lifestyle intervention that yields the benefits is restrictive. Jinlida is a Chinese patent medicine that has shown activity in type 2 diabetes, which has been approved in China. Preclinical studies in Jinlida granules support an improved role of abnormal glucose and lipids metabolism as well as reducing weight. Here, we describe the protocol of an ongoing clinical trial investigating a new therapy for metabolic syndrome in patients with abnormal glucose metabolism.  Methods:  This study will enroll 880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism. All the participants in a double-blind, parallel, randomized, placebo-controlled trial, will receive Jinlida or placebo, orally, 9 g/time, three times daily for 2-4 years period on the basis of lifestyle intervention. The primary outcome measure (Incidence of type 2 diabetes) will be assessed during intervention cycles. Adverse events were monitored. All statistical tests will be performed using a two-sided test, and a  p  ≤ 0.05 (two-sided test) will be considered to be statistically significant results.  Discussion:  Results from this study will provide evidence on whether incorporating oral Jinlida granules treatment into lifestyle intervention can delay or inhibit the development of diabetes mellitus in metabolic syndrome subjects with abnormal glucose metabolism.  Clinical trial registration:  Registered at http://www.chictr.org.cn/enIndex.aspx. Trial registration number: ChiCTR1900023241.",2020,Adverse events were monitored.,"['Patients With Abnormal Glucose Metabolism', '880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism', 'metabolic syndrome subjects with abnormal glucose metabolism', 'patients with abnormal glucose metabolism']","['Jinlida Granules', 'Jinlida or placebo', 'lifestyle intervention', 'placebo']","['Metabolic Syndrome', 'Incidence of type 2 diabetes', 'abnormal glucose and lipids metabolism', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C4079029', 'cui_str': 'jinlida'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",880.0,0.325082,Adverse events were monitored.,"[{'ForeName': 'De', 'Initials': '', 'LastName': 'Jin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Shuolong', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiovascularology, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Huailin', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiovascularology, Key Disciplines of State Administration of TCM for Collateral Disease, Shijiazhuang, China.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, Heibei Yiling Hospital, Shijiazhuang, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Piao', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Shenzhen Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xiao-Lin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00415']
1402,32681460,Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study.,"INTRODUCTION


Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in patients with type 2 diabetes (T2D) in France, Spain, and Germany.
METHODS


This retrospective chart review analysis used anonymized data for adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100. Outcomes included change from baseline to 6-month follow-up in glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice.
RESULTS


Six hundred sixty-five physicians (33.8% Spain, 31.7% France, 34.4% Germany) provided chart data for patients switching to Gla-300 (n = 679) or Gla-100 (n = 429) or initiating Gla-300 (n = 719) or Gla-100 (n = 711). After adjustment for baseline characteristics, A1C reductions from baseline were similar for patients switching to Gla-300 or Gla-100 (- 0.87% vs. - 0.93%; p = 0.326) while those switched to Gla-300 vs. Gla-100 had a significantly greater mean reduction in hypoglycemic events (- 1.29 vs. - 0.81 events during 6 months; p = 0.012). Mean insulin doses after titration were 0.43 ± 0.36 and 0.40 ± 0.28 U/kg in Gla-300 and Gla-100 switchers, respectively. Factors that significantly influenced BIA choice included a lower risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100). Outcomes for insulin-naïve patients were broadly similar to those of switchers.
CONCLUSIONS


In this real-world European study, patients with T2D who switched therapy to Gla-300 or Gla-100 had improved glycemic control and reduced hypoglycemia at 6 months, with significant hypoglycemia advantages with Gla-300.",2020,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","['Six hundred sixty-five physicians', '300 vs 100 U', 'adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100', 'patients with type 2 diabetes (T2D) in France, Spain, and Germany']","['Gla-300 and Gla-100', 'Insulin Glargine']","['glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice', 'risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100', 'Hypoglycemia Risk', 'Mean insulin doses', 'glycemic control and reduced hypoglycemia', 'hypoglycemic events', 'hypoglycemia risk']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",,0.0204853,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalada', 'Affiliation': 'Clinic University of Navarra, Pamplona, Spain. fjavier.escalada@gmail.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'CHU de Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Jasmanda', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Janelle M', 'Initials': 'JM', 'LastName': 'Cambron-Mellott', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Nicholls', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine, University Hospital Aachen, Aachen, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01436-5']
1403,32681461,"The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652 in First-in-Human and Ascending Multiple Oral Dose Studies in Healthy Subjects.","INTRODUCTION


Inhibitors of fatty acid amide hydrolase (FAAH) increase the levels of endocannabinoids and have shown analgesic and anti-inflammatory activity in animal models. ASP3652 is a peripherally acting FAAH inhibitor in development for the treatment of chronic bladder and pelvic pain disorders. Here we describe the safety, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ASP3652 administered in healthy non-elderly and elderly male and female volunteers.
METHODS


Study 1 was a combined single-ascending dose and food-effect study in which ASP3652 was given as single doses (1-600 mg) or matching placebo in healthy subjects. Study 2 was a multiple ascending dose study in which ASP3652 or matching placebo was administered in multiple oral doses (10-300 mg bid and 600 mg qd for 14 days) to healthy subjects. In both studies, the levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety were evaluated.
RESULTS


ASP3652 was readily absorbed to reach C max  at 1 h after a single dose. Steady state was reached within 3 days after the start of multiple dosing. The C max  and AUC of ASP3652 increased in a slightly more than dose-proportional manner after a single dose of ASP3652 at 30-600 mg. There was some accumulation (15-38%) based on C max  and AUC 12h  upon multiple doses. C max  was 47% lower in combination with food. There was no significant effect of gender or age on the pharmacokinetics of ASP3652. FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA). The incidence of adverse events following multiple doses was similar across all treatment groups including the placebo group.
CONCLUSIONS


Single and multiple doses of ASP3652 were safe and well tolerated and increased endogenous cannabinoid plasma levels.",2020,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","['healthy subjects', 'Healthy Subjects', 'healthy non-elderly and elderly male and female volunteers']","['placebo', 'ASP3652', 'matching placebo', 'ASP3652 or matching placebo']","['Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652', 'plasma levels of anandamide (AEA', 'safe and well tolerated and increased endogenous cannabinoid plasma levels', 'FAAH activity', 'Steady state', 'levels of ASP3652, FAAH, endocannabinoids (eCBs) and safety', 'adverse events', 'C max  and AUC of ASP3652']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0491394,"FAAH activity was inhibited in a dose-dependent manner in all dose groups after single and multiple doses of ASP3652, paralleled by an increase in plasma levels of anandamide (AEA).","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. masaomi.takizawa@astellas.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cerneus', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Michon', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Rijnders', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'van der Heide', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Meijer', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoelzel', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc., Ibaraki, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01402-1']
1404,32682856,A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway.,"BACKGROUND


Value in healthcare is reflected by patient-centered outcomes of care per health dollar expended. Although liposomal bupivacaine is more expensive, it has been shown to provide prolonged analgesia (up to 72 hours).
OBJECTIVE


This study aimed to evaluate whether the addition of liposomal bupivacaine to standard bupivacaine could decrease opioid intake and improve pain control after laparotomy for gynecologic surgery compared with standard bupivacaine alone in an enhanced recovery after surgery pathway.
STUDY DESIGN


A prospective randomized controlled single-blinded trial of wound infiltration with liposomal bupivacaine plus 0.25% bupivacaine (study arm) vs 0.25% bupivacaine (control arm) was performed at a National Cancer Institute-designated tertiary referral cancer center. Participants were patients aged ≥18 years undergoing exploratory laparotomy for a gynecologic indication. All patients were treated on an enhanced recovery pathway including local wound infiltration before closure. In this study, 266 mg of liposomal bupivacaine (free base; equal to 300 mg bupivacaine HCL)+150 mg of bupivacaine mixed in the same syringe was used in the study arm, and 150 mg of bupivacaine was used in the control arm. The primary outcome was the proportion of patients who were opioid-free within 48 hours after surgery. Secondary outcomes included number of opioid-free days from postoperative day 0 to postoperative day 3, days to first opioid administration, morphine equivalent daily dose, and patient-reported outcomes collected with the MD Anderson Symptom Inventory. The MD Anderson Symptom Inventory was administered as a preoperative baseline, daily while hospitalized, and at least weekly for 8 weeks after discharge. All outcomes were prespecified before data collection.
RESULTS


In this study, 102 patients were evaluated. Among them, 16.7% of patients in the study arm received no opioids up to 48 hours compared with 14.8% in the control arm (P=.99). There were no significant differences in the amount of intraoperative opioids administered or days to first opioid use. There was no significant difference between the 2 arms in median cumulative morphine equivalent daily dose (21.3 [study arm] vs 33.8 [control arm]; P=.36) or between the groups in morphine equivalent daily dose per individual day. There were no significant differences in patient-reported pain or interference with walking between the 2 arms or other patient-reported outcomes.
CONCLUSION


Within an enhanced recovery after surgery pathway, adding liposomal bupivacaine to 0.25% bupivacaine wound infiltration did not decrease the proportion of patients who were opioid-free within 48 hours after surgery, did not decrease opioid intake, or did not improve patient's self-reported pain and functional recovery compared with standard bupivacaine.",2020,"There were no significant differences in patient-reported pain or interference with walking between the two arms nor other PROs.
","['National Cancer Institute designated tertiary referral cancer center', 'Open Gynecologic Surgery', 'Participants were patients age 18 years or older undergoing exploratory laparotomy for a gynecologic indication', '102 patients were evaluable']","['bupivacaine HCL) + 150 mg of bupivacaine', 'bupivacaine', 'liposomal bupivacaine plus 0.25% bupivacaine', 'Liposomal Bupivacaine vs. Standard Bupivacaine', 'liposomal bupivacaine']","[""patient's self-reported pain and functional recovery"", 'number of opioid-free days from postoperative day 0-3, days to first opioid administration, morphine-equivalent daily dose (MEDD), patient-reported outcomes (PROs) collected with the MD-Anderson Symptom Inventory (MDASI', 'proportion of patients opioid free', 'median cumulative MEDD', 'opioid intake and improve pain control', 'proportion of opioid-free patients within 48 hours after surgery']","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085704', 'cui_str': 'Exploratory laparotomy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",102.0,0.14023,"There were no significant differences in patient-reported pain or interference with walking between the two arms nor other PROs.
","[{'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Meyer', 'Affiliation': 'Departments of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: lmeyer@mdanderson.org.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Corzo', 'Affiliation': 'Departments of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Iniesta', 'Affiliation': 'Departments of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Munsell', 'Affiliation': 'Biostatics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brandelyn', 'Initials': 'B', 'LastName': 'Pitcher', 'Affiliation': 'Biostatics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lasala', 'Affiliation': 'Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Cain', 'Affiliation': 'Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xin Shelly', 'Initials': 'XS', 'LastName': 'Wang', 'Affiliation': 'Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Mena', 'Affiliation': 'Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Departments of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.017']
1405,32682556,Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome.,"BACKGROUND


Norepinephrine is an effective vasopressor during spinal anaesthesia for Caesarean delivery. However, before it can be fully recommended, possible adverse effects on neonatal outcome should be excluded. We aimed to test the hypothesis that umbilical arterial cord pH is at least as good (non-inferior) when norepinephrine is used compared with phenylephrine for treatment of hypotension.
METHODS


We enrolled 668 subjects having elective and non-elective Caesarean delivery under spinal or combined spinal-epidural anaesthesia in this randomised, double-blind, two-arm parallel, non-inferiority clinical trial. Arterial blood pressure was maintained using norepinephrine 6 μg ml -1  or phenylephrine 100 μg ml -1  according to the practice of the anaesthetist, either prophylactically or therapeutically, as an infusion or bolus. The primary outcome was umbilical arterial pH with a chosen non-inferiority margin of 0.01 units.
RESULTS


Of 664 subjects (531 elective and 133 non-elective) who completed the study, umbilical arterial cord blood was analysed for 351 samples from 332 subjects in the norepinephrine group and 343 samples from 332 subjects in the phenylephrine group. Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017). Subgroup analysis confirmed the non-inferiority of norepinephrine for elective cases but was inconclusive for non-elective cases.
CONCLUSIONS


Norepinephrine was non-inferior to phenylephrine for neonatal outcome assessed by umbilical arterial pH. These results provide high-quality evidence supporting the fetal safety of norepinephrine in obstetric anaesthesia.
CLINICAL TRIAL REGISTRATION


ChiCTR-IPR-15006235.",2020,"Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017).","['664 subjects (531 elective and 133 non-elective) who completed the study', '332 subjects in the norepinephrine group and 343 samples from 332 subjects in the phenylephrine group', '668 subjects having elective and non', 'spinal anaesthesia for Caesarean delivery']","['phenylephrine', 'norepinephrine 6 μg ml -1  or phenylephrine', 'Norepinephrine', 'elective Caesarean delivery under spinal or combined spinal-epidural anaesthesia', 'Norepinephrine or phenylephrine', 'norepinephrine']","['umbilical arterial pH with a chosen non-inferiority margin of 0.01 units', 'Arterial blood pressure', 'umbilical arterial cord blood', 'Umbilical arterial pH']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}]",668.0,0.630435,"Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017).","[{'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Department of Anesthesiology, Sidra Medicine, Doha, Qatar. Electronic address: wngankee@gmail.com.'}, {'ForeName': 'Shara W Y', 'Initials': 'SWY', 'LastName': 'Lee', 'Affiliation': 'Department of Health Technology & Informatics, Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Floria F', 'Initials': 'FF', 'LastName': 'Ng', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.057']
1406,32662220,Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques-A pilot study.,"OBJECTIVE


The restoration of destroyed maxillary primary incisors is difficult because of the insufficient amount of coronal structure. This pilot study aimed to compare the efficacy of composite posts technique and glass fiber posts technique in restoring destroyed primary incisors.
MATERIALS AND METHODS


Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries were randomly assigned after endodontic treatment into two groups: glass fiber posts (n = 18) and composite resin posts (n = 18). Blinded clinical evaluation was made at 3, 6, 9, and 12 months and Blinded radiographic evaluation was made at 6 and 12 months. The evaluation was according to the FDI criteria. Data were analyzed with Fisher's exact test (α = .05).
RESULT


After 12 months post-treatment, the success rates were 88.2% in glass fiber posts group and 70.6% in composite resin posts group. There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
CONCLUSION


Glass fiber posts technique and Composite posts technique may be used in the restoration of destroyed primary incisors.",2020,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
",['Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries'],"['composite resin posts', 'composite posts technique and glass fiber posts technique', 'glass fiber posts']",['success rates'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0080038', 'cui_str': 'Post Technic'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]",[],11.0,0.0235983,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
","[{'ForeName': 'Seba', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}, {'ForeName': 'Abdul Wahab', 'Initials': 'AW', 'LastName': 'Nourallah', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}]",Clinical and experimental dental research,['10.1002/cre2.307']
1407,32665179,"Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study.","OBJECTIVES


The postoperative analgesic efficacy of transversus thoracic muscle plane block (TTMPB) has not yet been evaluated sufficiently. This randomized controlled study evaluated the effect of TTMPB on postoperative opioid consumption in patients undergoing cardiac surgery.
DESIGN


Prospective, randomized, double-blind study.
SETTINGS


Single institution, academic university hospital.
PARTICIPANTS


Forty-eight adult patients having cardiac surgery with median sternotomy.
INTERVENTIONS


Patients were randomly assigned to receive preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally. Postoperative analgesia was administered intravenously in the 2 groups 4 times a day with 1000 mg of paracetamol and patient-controlled analgesia with fentanyl.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was opioid consumption in the first 24 hours. Secondary outcomes included postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects. Compared with the control group (median 465 µg, interquartile range 415-585), the transversus thoracic muscle plane (TTMP) group (median 255 µg, interquartile range 235-305) had reduced postoperative 24-hour opioid consumption (p < 0.001). Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001). Compared with the TTMP group, the proportion of postoperative nausea and pruritus was statistically higher in the control group (p < 0.001).
CONCLUSIONS


A single preoperative TTMPB provided effective analgesia and decreased opioid requirements in patients undergoing cardiac surgery.",2020,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"['Single institution, academic university hospital', 'patients undergoing cardiac surgery', 'Forty-eight adult patients having cardiac surgery with median sternotomy']","['TTMP', 'paracetamol and patient-controlled analgesia with fentanyl', 'preoperative ultrasound-guided TTMPB with either 20 mL of 0.25% bupivacaine or saline bilaterally', 'transversus thoracic muscle plane block (TTMPB', 'TTMPB', 'Ultrasound-Guided Transversus Thoracic Muscle Plane Block']","['transversus thoracic muscle plane', 'postoperative opioid consumption', 'postoperative pain scores, first analgesic requirement time, rescue analgesia, intensive care discharge time, and side effects', 'postoperative 24-hour opioid consumption', 'opioid consumption', 'Postoperative Opioid Consumption', 'proportion of postoperative nausea and pruritus', 'postoperative analgesic efficacy', 'Pain scores', 'opioid requirements']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0224337', 'cui_str': 'Skeletal muscle structure of thorax'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.568675,Pain scores were significantly lower in the TTMP group compared with the control group up to 12 hours after surgery both at rest and active movement (p < 0.001).,"[{'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey. Electronic address: aliahiskalioglu@hotmail.com.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ibrahim Hakki', 'Initials': 'IH', 'LastName': 'Tor', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Borulu', 'Affiliation': 'Department of Cardiovascular Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ozlem Dilara', 'Initials': 'OD', 'LastName': 'Erguney', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Dogan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.06.044']
1408,32666291,Comparison of middle ear function and hearing thresholds in children with adenoid hypertrophy after microdebrider and conventional adenoidectomy: a randomised controlled trial.,"BACKGROUND


Microdebrider has superior efficacy in clearing the adenoids, compared to curettage. We compared the improvement in middle ear function and hearing thresholds after adenoidectomy, by both methods.
MATERIALS AND METHODS


126 patients (median age-9 years) were randomized into groups A and B, where adenoidectomy was done by microdebrider and curettage, respectively. Middle ear function parameters and hearing thresholds were measured serially.
RESULTS


The mean improvement in middle ear pressure, compliance and hearing thresholds were 92.5 ± 67.6 and 84.2 ± 71.4 daPa; (p = 0.40), 0.19 ± 0.34 and 0.27 ± 0.27 mL; (p = 0.07) and 3.20 ± 4.95 and 2.54 ± 3.98 dB; (p = 0.27), in groups A and B, respectively. Reversal of type B tympanograms was noted in both groups.
CONCLUSIONS


Middle ear function and hearing thresholds improved in both groups after adenoidectomy. More improvement was noted in the microdebrider group, which, however, was not significant.",2020,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"['children with adenoid hypertrophy after microdebrider and', '126 patients (median age-9\xa0years']",['conventional adenoidectomy'],"['Middle ear function parameters and hearing thresholds', 'middle ear function and hearing thresholds', 'mean improvement in middle ear pressure, compliance and hearing thresholds', 'Middle ear function and hearing thresholds']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}]","[{'cui': 'C0457585', 'cui_str': 'Middle ear function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",126.0,0.110676,Middle ear function and hearing thresholds improved in both groups after adenoidectomy.,"[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Rajan', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur, 342005, India. rajannikhil3@gmail.com.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Pradipta Kumar', 'Initials': 'PK', 'LastName': 'Parida', 'Affiliation': 'Department of Otorhinolaryngology, All India Institute of Medical Sciences, Bhubaneswar, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Sivaraman', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Otorhinolaryngology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06197-z']
1409,32668323,A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study).,"BACKGROUND


Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in heart failure (HF); incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care.
METHODS


In this single-blinded, randomized controlled trial, patients were randomized into an LUS-guided arm or control arm. Patients were followed in 4 prespecified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause.
RESULTS


One hundred twenty-six patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median left ventricular ejection fraction 31%). The primary end point occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients in the LUS group (P = .041). LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001). No significant differences in rehospitalizations for HF or death were found.
CONCLUSIONS


Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.",2020,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).",['One hundred twenty-six patients'],"['LUS-guided arm or control arm', 'lung ultrasound-guided therapy', 'Lung ultrasound (LUS', 'LUS']","['rate of adverse events', 'urgent HF visits', 'rehospitalizations for HF or death', 'composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause', 'risk of urgent visits']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",126.0,0.114217,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Araiza-Garaygordobil', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico. Electronic address: dargaray@gmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gopar-Nieto', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Amezcua', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cabello-López', 'Affiliation': 'Centro Médico Nacional ""Siglo XXI,"" Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Alanis-Estrada', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Luna-Herbert', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Cynthia Paola', 'Initials': 'CP', 'LastName': 'Paredes-Paucar', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Martinez Daniel', 'Initials': 'MD', 'LastName': 'Sierra-Lara', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Briseño-De la Cruz', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Rodriguez-Zanella', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Martinez-Rios', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arias-Mendoza', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}]",American heart journal,['10.1016/j.ahj.2020.06.003']
1410,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1411,32675750,Diabetes and CYP2C19 Polymorphism Synergistically Impair the Antiplatelet Activity of Clopidogrel Compared With Ticagrelor in Percutaneous Coronary Intervention-treated Acute Coronary Syndrome Patients.,"Diabetes and CYP2C19 loss of function (LOF) alleles are associated with the variable antiplatelet activity of the prodrug clopidogrel. We conducted a randomized trial (NCT03613857) to compare the combined and individualized effects of diabetes and CYP2C19 polymorphisms on the antiplatelet reactivity of clopidogrel versus ticagrelor in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Patients (948, 1 year follow-up 943) were randomly allocated in a 1:1 ratio to receive either clopidogrel or ticagrelor, after PCI; patients were subdivided into 8 subgroups according to the diabetes and/or CYP2C19 allele status. The study outcomes were recurrent ACS, maximum platelet aggregation (MPA), high platelet reactivity index (PRI), and incidence of major bleeding events. Diabetic patients with LOF alleles taking clopidogrel had the highest recurrent ACS rate (6 of 33 patients) versus all other study groups (P < 0.05). However, both drugs had similar proportions of recurrent ACS in all other subgroups. Similarly, both PRI and MPA were significantly higher in the diabetic patients having LOF alleles and receiving clopidogrel versus all their study groups (P < 0.05). Nevertheless, ticagrelor caused higher rates of major bleeding versus clopidogrel (P < 0.001). PCI-treated ACS patients with diabetes and CYP2C19 LOF alleles are at a higher risk of recurrent ACS and high PRI/MPA, when treated with clopidogrel versus ticagrelor, but almost comparable outcomes are recorded in the absence of 1 or the 2 risk factors.",2020,all other study groups (p<0.05).,"['Patients (948, 1 year follow-up 943', 'patients with diabetes and CYP2C19 LOF alleles', 'ACS patients undergoing percutaneous coronary intervention (PCI', 'Diabetic patients with LOF alleles taking']","['Ticagrelor', 'ticagrelor', 'clopidogrel vs ticagrelor', 'clopidogrel or ticagrelor', 'clopidogrel', 'PCI-treated ACS', 'Clopidogrel']","['PRI and MPA', 'highest recurrent ACS rate', 'recurrent ACS', 'Diabetes and CYP2C19 loss of function (LOF) alleles', 'recurrent ACS, maximum platelet aggregation (MPA),high platelet reactivity index (PRI),and incidence of major bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",33.0,0.0150386,all other study groups (p<0.05).,"[{'ForeName': 'Mina W', 'Initials': 'MW', 'LastName': 'Mohareb', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'AbdElghany', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hala F', 'Initials': 'HF', 'LastName': 'Zaki', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hanan S', 'Initials': 'HS', 'LastName': 'El-Abhar', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Cairo, Egypt.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000881']
1412,32674155,"Corrigendum to: ""Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study"" by Russo et al. Neurosurgery, 2020, nyaa003, https://doi.org/10.1093/neuros/nyaa003.",,2020,,[],['Closed-Loop Spinal Cord Stimulation'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]",[],,0.0133076,,[],Neurosurgery,['10.1093/neuros/nyaa332']
1413,32679281,"China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial.","Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.",2020,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","['patients with Acute Myocardial Infarction (CTS-AMI', '3,796 eligible patients with STEMI from about 120 centers']","['Tongxinluo (TXL', 'TXL', 'TXL or placebo', 'placebo']","['each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters', '30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1742872', 'cui_str': 'tongxinluo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3796.0,0.355531,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qiuting', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guangyuan', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guihao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ruijie', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yangyjfw@126.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.011']
1414,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1415,32674714,A Prescription for Wellness: Exercise Referrals at a Federally Qualified Health Center.,"Introduction/Objectives:  Physical activity (PA) improves quality of life and prevents chronic disease, but many adults are inactive. Planning with a health care provider in the form of an exercise ""prescription"" or referral may increase PA, but determinants of referral utilization are not well understood among underserved populations. This study examined sociodemographic and theory-based psychosocial determinants of exercise referral program utilization.  Methods:  Patients at a large, federally qualified health center with an on-site exercise facility (ie, ""Wellness Center"") referral were eligible to exercise with a personal fitness advisor. Self-reported PA behavior, self-efficacy, and self-regulation strategies were measured via survey and merged with electronic health records and attendance data. Negative binomial regression was used to estimate the rate of Wellness Center utilization.  Results:  Patients with exercise referrals (n = 1136) were, on average, 45.6 ± 14.6 years, 78.8% female, and 78.0% Hispanic/Latino or non-Hispanic Black. Approximately half (593/1136; 52.2%) initiated exercise at the Wellness Center; initiators completed 8.8 ± 12.4 visits during follow-up. Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03). Baseline self-efficacy ( P  < .001) and self-regulation strategies ( P  = .03) were significantly associated with follow-up PA, even after adjusting for baseline PA.  Conclusions:  In this racially/ethnically diverse patient population, older and less active patients at baseline had higher program utilization. Patients with higher self-efficacy and self-regulation strategies reported higher PA over time. Community health centers have a unique opportunity to support PA through exercise referral programs to public health priority populations.",2020,"Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03).","['were, on average, 45.6 ± 14.6 years, 78.8% female, and 78.0% Hispanic/Latino or non-Hispanic Black', 'Results:  Patients with exercise referrals (n = 1136', 'Methods:  Patients at a large, federally qualified health center with an on-site exercise facility (ie, ""Wellness Center', 'Wellness: Exercise Referrals at a Federally Qualified Health Center']",['Physical activity (PA'],"['quality of life and prevents chronic disease', 'Self-reported PA behavior, self-efficacy, and self-regulation strategies', 'Baseline self-efficacy', 'self-regulation strategies']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C5191065', 'cui_str': '1136'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0600622', 'cui_str': 'Wellness Centers'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",1136.0,0.0233475,"Older age was associated with higher utilization ( P  < .001) and patients meeting PA recommendations had lower utilization than patients not meeting recommendations (incident rate ratio = 0.72, 95% CI 0.53-0.97;  P  = .03).","[{'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Ylitalo', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cox', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Gutierrez', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Benavidez', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'M Renée', 'Initials': 'MR', 'LastName': 'Umstattd Meyer', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Niceler', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}, {'ForeName': 'Jackson O', 'Initials': 'JO', 'LastName': 'Griggs', 'Affiliation': 'Heart of Texas Community Health Center, Waco, TX, USA.'}]",Journal of primary care & community health,['10.1177/2150132720942396']
1416,32675390,Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial.,"BACKGROUND


Exercise programs in the treatment of chronic lumbar pain are quite diverse, but it has been proven that stabilization exercises are the most effective.
OBJECTIVE


We compared the lumbar stabilization exercise program in a closed and open kinetic chain (LSCO) and lumbar stabilization exercises and thoracic mobilization program in a closed kinetic chain (LSTMC), and evaluated the clinical effectiveness of each program.
METHODS


Prospective, randomized, controlled trial in 80 chronic low back pain (CLBP) patients with lumbar radiculopathy of both sexes (35 male, 45 female), average age (48.45 ± 10.22 years), divided in two groups that performed different sets of exercises. Participants were given laser therapy, transcutaneous electro-nerve stimulation and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done after four and eight weeks.
RESULTS


Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
CONCLUSION


Patients who performed the lumbar stabilization and thoracic mobilization exercise program in a closed kinetic chain had the most effective reduction of pain intensity and functional disability.",2020,"Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
","['chronic low back pain patients with lumbar radiculopathy', '80 chronic low back pain (CLBP) patients with lumbar radiculopathy of both sexes (35 male, 45 female), average age (48.45 ± 10.22 years']","['open kinetic chain (LSCO) and lumbar stabilization exercises and thoracic mobilization program', 'lumbar stabilization and thoracic mobilization exercise program', 'laser therapy, transcutaneous electro-nerve stimulation and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers', 'lumbar stabilization exercise program', 'thoracic mobilization exercise program', 'LSCO']","['pain intensity and functional disability reduction', 'pain intensity and functional disability', 'pain intensity and functional disability parameters']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",80.0,0.041617,"Statistically significant (p< 0.05) superior recovery of the LSTMC group subjects compared to the LSCO group was achieved at all measurement intervals in the pain intensity and functional disability parameters.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kostadinović', 'Affiliation': 'Medical Faculty, University of Novi Sad, Clinical Research, Novi Sad, Serbia.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Milovanović', 'Affiliation': 'Rehabilitation Clinic ""Dr. Miroslav Zotović"" Belgrade, University of Belgrade, School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Jovanović', 'Affiliation': 'Rehabilitation Clinic ""Dr. Miroslav Zotović"" Belgrade, University of Belgrade, School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Snežana', 'Initials': 'S', 'LastName': 'Tomašević-Todorović', 'Affiliation': 'Medical Faculty, University of Novi Sad, Medical Rehabilitation Clinic, Clinical Centre of Vojvodina, Novi Sad, Serbia.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-201843']
1417,32673060,Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.,"BACKGROUND


No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).
OBJECTIVE


To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.
DESIGN


Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).
SETTING


Internet-based trial across the United States and Canada (40 states and 3 provinces).
PARTICIPANTS


Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.
INTERVENTION


Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.  Measures : Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
RESULTS


Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 points [95% CI, -0.61 to 0.07 points];  P  = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo ( P  = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo ( P  < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
LIMITATIONS


Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.
CONCLUSION


Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.
PRIMARY FUNDING SOURCE


Private donors.",2020,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","['outpatients with early, mild COVID-19', 'Nonhospitalized Adults', '22 March through 20 May 2020', '341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting', 'Internet-based trial across the United States and Canada', 'Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset', 'adult outpatients', '491 patients randomly assigned to a group, 423 contributed primary end point data']","['hydroxychloroquine', 'Hydroxychloroquine', 'Early COVID-19', 'Oral hydroxychloroquine', 'placebo']","['ongoing symptoms', 'overall symptom severity', '10-point visual analogue scale', 'Medication adverse effects', 'symptom severity', 'hospitalized death', 'Change in symptom severity', 'COVID-19 severity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",423.0,0.761778,"With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death ( P  = 0.29).
","[{'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Darlette', 'Initials': 'D', 'LastName': 'Luke', 'Affiliation': 'M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (I.S.S.).'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).'}]",Annals of internal medicine,['10.7326/M20-4207']
1418,32679434,"Diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults are detected by continuous glucose monitoring-a randomized crossover trial.","Continuous glucose monitors (CGMs) have been developed for diabetic patients for estimating and controlling plasma glucose changes throughout the day. However, elevated postprandial glucose concentrations may also be detrimental for non-diabetic subjects by increasing the risk of developing vascular complications and type 2 diabetes. Therefore, CGMs may also be valuable in clinical research and we hypothesized that diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults could be detected by the Abbott FreeStyle Libre Pro CGM. In this single-blind randomized cross-over trial, 23 healthy but overweight or obese men and women therefore consumed two diets differing in glycemic load in randomized order for three consecutive days. Based on the CGM measurements, two-hour total areas under the curve (tAUCs) after breakfast, lunch and dinner were calculated. Additionally, postprandial glucose was measured with the CGM and in plasma during a rice meal challenge. The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001). The same conclusions were drawn when tAUCs for breakfast (P < .0001), lunch (P < .0001) and dinner (P < .0001) were analyzed separately. During the rice meal challenge, significantly higher glucose responses were observed after the low GL period, as monitored by both the CGM device (P < .0001) and the plasma glucose analysis (P < .0001). The difference between the means of both methods was 0.11 mmol/L (1.78%) with a higher glucose value in plasma. The absolute mean difference was 0.66 mmol/L (10.5%). We conclude that the CGM detected diet-induced differences in estimated plasma glucose concentrations, which supports its use not only in clinical practice, but also for research purposes during dietary interventions in non-diabetic participants.",2020,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"['healthy, non-diabetic adults', '23 healthy but overweight or obese men and women', 'non-diabetic participants', 'diabetic patients']",['Continuous glucose monitors (CGMs'],"['elevated postprandial glucose concentrations', 'average tAUC', 'glucose responses', 'plasma glucose analysis', 'plasma glucose concentrations', 'postprandial glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}]",23.0,0.0315526,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: eva.fechner@outlook.com.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': ""Op 't Eyndt"", 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: cara.opteyndt@mumc.nl.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Unilever Foods Innovation Center - Hive, Bronland 14, 6708, WH, Wageningen, The Netherlands. Electronic address: theo.mulder@unilever.com.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: r.mensink@maastrichtuniversity.nl.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.06.001']
1419,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1420,32696304,Impact of Phone-Call and Access-Enhancing Intervention on Mammography Uptake among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Controlled Study.,"BACKGROUND


Our urban safety-net hospital (SNH) has very low screening mammogram rates within its primary care clinics. Despite Commission on Cancer (CoC) accreditation, we see ~ 3 × more late-stage breast cancer diagnoses than other CoC sites across the country, and recently showed this to be strongly associated with lack of screening (Ahmadiyeh et al. in J Health Care Poor Underserved, in press, 2020). Here we study whether a two-step intervention (phone calls and assistance scheduling mammograms) increases uptake over usual care.
PATIENTS AND METHODS


Randomized controlled study of 890 women aged 50-65 years who were due for biennial screening mammograms and who were established within one of five primary care clinics at an urban SNH. Each patient in the intervention group was called with overdue status (up to three times, voicemail left if needed) and offered assistance scheduling mammogram appointment. Mammography uptake at 3 and 6 months was analyzed.
RESULTS


Intervention significantly increased uptake compared with usual care at both timepoints (18% versus 6% at 3 months; χ 2  = 27.597, p < 0.0001; 23% versus 12% at 6 months; χ 2  = 18.0, p < 0.0001), with scheduling component driving effectiveness. Of those who were successfully contacted, uptake was significantly greater among those who scheduled appointments versus those who did not (47% versus 9%, χ 2  = 95, p < 0.0001), and uptake was no different between contacted but not scheduled patients and usual care controls.
CONCLUSIONS


Phone call with access-enhancing intervention (facilitating mammogram appointments) increased screening mammogram uptake among primary care patients in an urban safety-net setting and may be applicable to other urban SNHs around the country.",2020,"RESULTS


Intervention significantly increased uptake compared with usual care at both timepoints (18% versus 6% at 3 months; χ 2  = 27.597, p < 0.0001; 23% versus 12% at 6 months; χ 2  = 18.0, p < 0.0001), with scheduling component driving effectiveness.","['890 women aged 50-65\xa0years who were due for biennial screening mammograms and who were established within one of five primary care clinics at an urban SNH', 'Primary Care Patients at an Urban Safety-Net Hospital']","['Phone-Call and Access-Enhancing Intervention', 'Phone call with access-enhancing intervention (facilitating mammogram appointments', 'two-step intervention (phone calls and assistance scheduling mammograms']","['Mammography Uptake', 'screening mammogram uptake', 'Mammography uptake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0203028', 'cui_str': 'Screening mammography'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",890.0,0.0457554,"RESULTS


Intervention significantly increased uptake compared with usual care at both timepoints (18% versus 6% at 3 months; χ 2  = 27.597, p < 0.0001; 23% versus 12% at 6 months; χ 2  = 18.0, p < 0.0001), with scheduling component driving effectiveness.","[{'ForeName': 'Asha D', 'Initials': 'AD', 'LastName': 'Nanda', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Mann', 'Affiliation': 'Truman Medical Centers, Kansas City, MO, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Moormeier', 'Affiliation': 'Truman Medical Centers, Kansas City, MO, USA.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Ahmadiyeh', 'Affiliation': 'Truman Medical Centers, Kansas City, MO, USA. ahmadiyehn@umkc.edu.'}]",Annals of surgical oncology,['10.1245/s10434-020-08884-x']
1421,32694494,Facet Arthropathy Following Disc Replacement Versus Rehabilitation: A Prospective Study With 8-Year Follow-Up.,"STUDY DESIGN


A prospective study of patients originally randomized to total disc replacement (TDR) or multidisciplinary rehabilitation.
OBJECTIVE


To assess the long-term development of facet arthropathy (FA) after TDR versus nonoperative treatment, and to analyze the association between FA and clinical outcome.
SUMMARY OF BACKGROUND DATA


FA may appear or increase following TDR, but the natural course of FA is unclear, and no previous study has evaluated the long-term development of FA following TDR compared with nonoperative treatment.
METHODS


The study included 126 patients with chronic low back pain and degenerative changes in the lumbar intervertebral discs. The patients underwent pretreatment and 8-year follow-up magnetic resonance imaging (MRI) and 8-year follow-up computed tomography (CT) of the lumbar spine. The primary outcome measure was FA development (yes/no) on MRI at index level L4/L5 or L5/S1, defined as increased FA grade value from pretreatment to follow-up according to Weishaupt grading system. Secondary outcomes included the association between FA (on MRI and CT) and Oswestry Disability Index (ODI) or back pain as well as reoperations.
RESULTS


Increased index level FA grade was more frequent after TDR versus nonoperative treatment (36%, 25/69 vs. 2%, 1/57 of patients, P < 0.001), but was not related to change in ODI or back pain. At follow-up, index level FA grades were higher after TDR versus nonoperative treatment (odds ratio 4.0 MRI and 5.9 CT), but were not related to ODI less than or equal to 22. Four patients (6%) treated with TDR and no patients treated nonoperatively were operated for lateral recess stenosis with posterior decompression at the index level during follow-up.
CONCLUSION


Index level FA development was more likely after TDR compared with nonoperative treatment but was not associated with the 8-year clinical outcome. Index level FA may have contributed to reoperations in the TDR group.
LEVEL OF EVIDENCE


2.",2020,"At follow-up, index level FA grades were higher after TDR versus non-operative treatment (odds ratio 4.0 MRI and 5.9 CT), but were not related to ODI ≤ 22.",['126 patients with chronic low back pain and degenerative changes in the lumbar intervertebral discs'],"['TDR', 'Disc Replacement Versus Rehabilitation', 'pre-treatment and eight-year follow-up magnetic resonance imaging (MRI) and eight-year follow-up computed tomography (CT) of the lumbar spine', 'total disc replacement (TDR) or multidisciplinary rehabilitation']","['Index level FA development', 'index level FA grades', 'Facet Arthropathy', 'association between FA (on MRI and CT) and Oswestry Disability Index (ODI) or back pain as well as reoperations', 'FA development (yes/no) on MRI at index level L4/L5 or L5/S1, defined as increased FA grade value', 'index level FA grade', 'ODI or back pain']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}]","[{'cui': 'C2144940', 'cui_str': 'Total Disk Replacement'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441799', 'cui_str': 'Grading values'}]",126.0,0.0217514,"At follow-up, index level FA grades were higher after TDR versus non-operative treatment (odds ratio 4.0 MRI and 5.9 CT), but were not related to ODI ≤ 22.","[{'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Furunes', 'Affiliation': 'Department of Surgery, Innlandet Hospital Gjøvik, Gjøvik, Norway.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Berg', 'Affiliation': 'Department of Radiology, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Thoresen', 'Affiliation': 'Department of Radiology, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Neckelmann', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Helga Maria', 'Initials': 'HM', 'LastName': 'Brøgger', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Research- and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Research- and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellum', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Spine,['10.1097/BRS.0000000000003600']
1422,32697197,Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.,"BACKGROUND


Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence.
OBJECTIVE


This study aims to explore the mechanisms of action underpinning the intervention.
METHODS


A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis.
RESULTS


The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer.
CONCLUSIONS


The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797.",2020,"There was also evidence of Vassilev's mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit.","['adults with cystic fibrosis', '25 semi-structured interviews', '19 UK cystic fibrosis centers', 'two UK cystic fibrosis centers', 'adults with Cystic Fibrosis']","['complex intervention', 'health professional support']",['nebulizer adherence'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2.0,0.0567727,"There was also evidence of Vassilev's mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Drabble', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': ""O'Cathain"", 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Scott', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Madelynne A', 'Initials': 'MA', 'LastName': 'Arden', 'Affiliation': 'Centre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Keating', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Sheffield Adult CF Centre, Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Maguire', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wildman', 'Affiliation': 'Sheffield Adult CF Centre, Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16782']
1423,32697335,A quality-adjusted survival time without symptoms or toxicities analysis of glasdegib plus low-dose cytarabine versus low-dose cytarabine as initial therapy for acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy.,"BACKGROUND


In a randomized study, glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC) significantly prolonged survival in comparison with LDAC in patients with acute myeloid leukemia (AML). A quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) approach was used to evaluate comparative quality-adjusted survival.
METHODS


Overall survival was partitioned into the following: time with any treatment-emergent grade 3 or higher adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL). Q-TWiST was calculated by multiplying the restricted mean time in each state by respective utilities and then summing up the utility-adjusted time.
RESULTS


At 20 months of follow-up, the survival probabilities for the glasdegib-LDAC arm and the LDAC arm were 28.2% and 7.9%, respectively. Glasdegib-LDAC patients (n = 78), in comparison with LDAC patients (n = 38), had significantly longer mean TWiST (+3.4 months; 95% confidence interval [CI], 1.8-5.2 months) and TOX (+0.8 months; 95% CI, 0.1-1.6 months) and longer but nonsignificant REL (+0.3 months; 95% CI, -1.9 to 2.3 months). Q-TWiST was 4.0 months (95% CI, 2.1-5.8 months) longer with glasdegib plus LDAC, and this translated into a 75% relative improvement in quality-adjusted survival with respect to LDAC. Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
CONCLUSIONS


These results suggest that most of the survival benefit from glasdegib plus LDAC versus LDAC alone is TWiST, and this represents added time in relatively ""good"" health. These results support the clinical value of glasdegib plus LDAC as initial therapy for AML in patients for whom intensive chemotherapy is not an option.",2020,"Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
","['acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC', 'LDAC', 'glasdegib plus low-dose cytarabine']","['comparative quality-adjusted survival', 'survival probabilities', 'adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL', 'TOX', 'quality-adjusted survival', 'longer mean TWiST']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0018866', 'cui_str': 'Erinaceidae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107607,"Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
","[{'ForeName': 'Caitlyn T', 'Initials': 'CT', 'LastName': 'Solem', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Bell', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Kwon', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bhattacharyya', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Hoang', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}]",Cancer,['10.1002/cncr.33072']
1424,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE


Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY


In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS


A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS


The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION


Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2020,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
1425,32693197,"Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.","Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.",2020,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","['patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft', 'subjects with atrial fibrillation or with venous thromboembolism', '1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3\u202fmonths prior', 'patients with a mechanical heart valve', 'patients with a mechanical On-X Aortic Heart Valve']","['PROACT Xa', 'apixaban 5\u202fmg twice daily or warfarin', 'apixaban versus warfarin', 'apixaban', 'warfarin', 'Vitamin K antagonists', 'apixaban with warfarin']","['efficacy and safety', 'composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding', 'hazard rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C3530472', 'cui_str': 'apixaban 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0697264,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brittanny', 'Initials': 'B', 'LastName': 'Boyer', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Diseases, University of Cincinnati Heart, Lung & Vascular Institute, Cincinnati, OH.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Blackstone', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai St. Luke's, New York, NY.""}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiothoracic Surgery, Franciscan Hospital, Indianapolis, IN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Capps', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Svensson', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}]",American heart journal,['10.1016/j.ahj.2020.06.014']
1426,32699034,"Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial.","OBJECTIVES


This ongoing Phase-2, randomised, placebo-controlled, double-blind study evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE).
METHODS


Patients (5 to 17 years) were randomised to belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy. Primary endpoint: SLE Responder Index (SRI4) response rate (Week 52). Key major secondary endpoints: proportion of patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global). Safety and pharmacokinetics were assessed. Study not powered for statistical testing.
RESULTS


Ninety-three patients were randomised (belimumab, n=53; placebo, n=40). At Week 52, there were numerically more SRI4 responders with belimumab versus placebo (52.8% vs 43.6%; OR 1.49 (95% CI 0.64 to 3.46)). PRINTO/ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)). Serious adverse events were reported in 17.0% of belimumab patients and 35.0% of placebo patients; one death occurred (placebo). Week-52, geometric mean (95% CI) belimumab trough concentration was 56.2 (45.2 to 69.8) µg/mL.
CONCLUSION


The belimumab intravenous pharmacokinetics and benefit-risk profile in cSLE are consistent with adult belimumab studies and the 10 mg/kg every 4 weeks dose is appropriate.
TRIAL REGISTRATION NUMBER


NCT01649765.",2020,"ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)).","['childhood-onset systemic lupus erythematosus (cSLE', 'Ninety-three patients were randomised (belimumab, n=53', 'Patients (5 to 17 years', 'children with systemic lupus erythematosus']","['placebo', 'belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy', 'intravenous belimumab']","['efficacy, safety and pharmacokinetics', 'death', 'Safety and pharmacokinetics', 'Safety and efficacy', 'SRI4 responders', ""patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global"", 'SLE Responder Index (SRI4) response rate (Week 52', 'Serious adverse events']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",93.0,0.776003,"ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)).","[{'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA Hermine.brunner@cchmc.org.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Abud-Mendoza', 'Affiliation': 'Hospital Central ""Dr Ignacio Morones Prieto"", Unidad Regional de Reumatologia y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico.'}, {'ForeName': 'Diego O', 'Initials': 'DO', 'LastName': 'Viola', 'Affiliation': 'Reumatologia, Instituto CAICI, Rosario, Argentina.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Calvo Penades', 'Affiliation': 'Pediatric Rheumatology Unit, Hospital Universitario y Politecnico la Fe, Valencia, Spain.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'Rheumatology, Hospital for Sick Children and Univeristy of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Anton', 'Affiliation': 'Division of Pediatric Rheumatology, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Calderon', 'Affiliation': 'El Derby, Instituto de Ginecologia y Reproduccion, Lima, Peru.'}, {'ForeName': 'Vyacheslav G', 'Initials': 'VG', 'LastName': 'Chasnyk', 'Affiliation': 'Department of Hospital Pediatrics, Saint Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Ferrandiz', 'Affiliation': 'Reumatologia, Instituto Nacional de Salud del Niño, Lima, Peru.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Keltsev', 'Affiliation': 'Pediatric Department, Togliatti City Clinical Hospital №5, Togliatti, Russian Federation.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Paz Gastanaga', 'Affiliation': 'Servicio de Reumatologia, Clinica Anglo Americana, Lima, Peru.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shishov', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, Arizona, USA.""}, {'ForeName': 'Alina Lucica', 'Initials': 'AL', 'LastName': 'Boteanu', 'Affiliation': 'Pediatric Rheumatology Unit, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Henrickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Bass', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'GSK, Stevenage, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Beulah N', 'Initials': 'BN', 'LastName': 'Ji', 'Affiliation': 'GSK, Stevenage, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nino', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Roth', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Struemper', 'Affiliation': 'GSK, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Mei-Lun', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genova, Liguria, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lovell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia, PRINTO, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217101']
1427,32700359,Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion.,"OBJECTIVE


To determine whether addition of letrozole to a misoprostol-based abortion regimen can increase the rate of complete abortion.
METHODS


The randomized, placebo-controlled, double-blind trial enrolled women with missed abortion in the first trimester of pregnancy attending Sadooghi Hospital, Isfahan, Iran, from 2016 to 2018. The women were randomly assigned to the study group, which received 10 mg of letrozole daily for 3 days, followed by two doses of 800 μg of vaginal misoprostol at a 4-hour interval, or the control group, which received a placebo, followed by the same dose of misoprostol. Sonography was performed to check the abortion status.
RESULTS


In total, 120 women completed the study: 60 in the misoprostol plus letrozole group, and 60 in the misoprostol only group. Complete abortion was documented for 93 (77.5%) women: 48 (80.0%) in the misoprostol plus letrozole group and 45 (75.0%) in the misoprostol only group (P=0.80). The mean duration of induction in the misoprostol plus letrozole and misoprostol only groups was 7.35 ± 3.54 hours and 8.2 ± 3.8 4hours, respectively (P=0.21).
CONCLUSION


Administration of misoprostol alone was found to be as effective as the administration of misoprostol plus letrozole for first-trimester missed abortion.",2020,Complete abortion was documented for 93 (77.5%) women: 48 (80.0%) in the misoprostol plus letrozole group and 45 (75.0%) in the misoprostol only group (P=0.80).,"['women with first-trimester missed abortion', 'enrolled women with missed abortion in the first trimester of pregnancy attending Sadooghi Hospital, Isfahan, Iran, from 2016 to 2018', '120 women completed the study: 60 in the']","['misoprostol-based abortion regimen', 'misoprostol with and without letrozole', 'misoprostol', 'letrozole', 'misoprostol plus letrozole', 'vaginal misoprostol', 'placebo']","['Complete abortion', 'mean duration of induction', 'induction of abortion', 'rate of complete abortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0233105', 'cui_str': 'Abortion complete'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",120.0,0.443939,Complete abortion was documented for 93 (77.5%) women: 48 (80.0%) in the misoprostol plus letrozole group and 45 (75.0%) in the misoprostol only group (P=0.80).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Allameh', 'Affiliation': 'Department of Obstetrics & Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Goharian', 'Affiliation': 'Department of Obstetrics & Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Eslamian', 'Affiliation': 'Department of Surgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13326']
1428,32701012,"Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study.","Purpose:  To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK).  Methods:  This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED ™ ) Questionnaire, slit lamp, intraocular pressure, and fundus examinations.  Results:  The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups.  Conclusion:  OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery.",2020,"On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control.","['Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect', 'After Photorefractive Keratectomy']","['OBG', 'hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears', 'Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization']","['proportion of patients with complete healing', 'Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing', 'SPEED scores', 'adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED ™ ) Questionnaire, slit lamp, intraocular pressure, and fundus examinations', 'mean wound size']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022772', 'cui_str': ""Democratic people's republic of Korea""}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0948085', 'cui_str': 'Corneal defect'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",45.0,0.061894,"On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control.","[{'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Wolsey', 'Affiliation': 'The Eye Institute of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Slade', 'Affiliation': 'Slade & Baker Vision Center, Houston, Texas, USA.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Wirostko', 'Affiliation': 'EyeGate Pharmaceuticals, Inc., Salt Lake City, Utah, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Brandano', 'Affiliation': 'EyeGate Pharmaceuticals, Inc., Waltham, Massachusetts, USA.'}, {'ForeName': 'Brenda K', 'Initials': 'BK', 'LastName': 'Mann', 'Affiliation': 'EyeGate Pharmaceuticals, Inc., Salt Lake City, Utah, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Durrie', 'Affiliation': 'Durrie Vision, Overland Park, Kansas, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Thompson', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, South Dakota, USA.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0156']
1429,32700515,Efficacy of a Stannous-containing Dentifrice for Protecting Against Combined Erosive and Abrasive Tooth Wear In Situ.,"PURPOSE


The in-situ efficacy of an experimental stannous (Sn)-containing sodium fluoride (NaF) dentifrice against erosion and erosive tooth wear was compared with a conventional NaF dentifrice.
MATERIALS AND METHODS


This was a randomised, controlled, double-blind, parallel-group clinical trial. Mandibular appliances containing four enamel specimens (2 per side [L/R] of the appliance) were worn by 60 generally healthy adult subjects. Subjects were randomised to treatment based on age and gender. Treatments included a Sn-containing NaF or conventional NaF dentifrice. Conditions of erosion (dentifrice slurry treatment) and erosion/tooth wear (dentifrice slurry plus brushing) were compared. Dentifrices were used twice per day for 30 s of lingual brushing, followed by 90 s of slurry exposure. In addition, the two specimens on the left side of the mouth were brushed for 5 s each, using a power toothbrush. All specimens were exposed to four daily erosive challenges with commercial orange juice (pH 3.6). Tooth wear was measured as enamel loss using non-contact profilometry on day 10.
RESULTS


At the day 10 visit, the adjusted mean (SE) enamel loss for specimens receiving slurry (erosion) treatment was 4.7 µm (0.61) [Sn-containing NaF] and 8.73 µm (1.12) [NaF control], with results demonstrating a statistically significant benefit for the Sn-containing dentifrice (46.2% benefit; p = 0.009). For specimens exposed to erosion/tooth wear conditions, enamel loss = 6.68 µm (1.29) (Sn-containing NaF) and 10.99 µm (1.29) (NaF group), with results statistically significant (p = 0.048; 39.2% better, favouring the Sn-containing dentifrice). When data were combined, enamel loss (SE) for all specimens subjected to erosion + erosion/tooth wear was 5.61 µm (0.77) (Sn-containing NaF]) and 9.9 µm (1.3) (NaF group). The difference again was statistically significant, favouring the Sn-containing group (p = 0.022; 43.4% better).
CONCLUSIONS


The Sn-containing dentifrice demonstrated significantly better protection than did NaF under erosive and erosive/tooth wear conditions.",2020,The Sn-containing dentifrice demonstrated significantly better protection than did NaF under erosive and erosive/tooth wear conditions.,['Mandibular appliances containing four enamel specimens (2 per side [L/R] of the appliance) were worn by 60 generally healthy adult subjects'],"['experimental stannous (Sn)-containing sodium fluoride (NaF) dentifrice', 'Dentifrices', 'Stannous-\ufeffcontaining Dentifrice', 'conventional NaF dentifrice', 'Sn-containing NaF or conventional NaF dentifrice']",['enamel loss'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",60.0,0.0809518,The Sn-containing dentifrice demonstrated significantly better protection than did NaF under erosive and erosive/tooth wear conditions.,"[{'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44926']
1430,32700009,Comparison of Rapid Absorbable Sutures with Nonabsorbable Sutures in Closing Transcolumellar Incision in Septorhinoplasty: Short-term Outcomes.,"BACKGROUND


Following open rhinoplasty, a postoperative scar at the columellar incision line is a common morbidity. The aim of this study is to compare absorbable and nonabsorbable suture materials which had been used for closing the transcolumellar incision, in the aspect of risk of postoperative infection, wound healing, postoperative columellar scar and patient satisfaction.
METHOD


A prospective, randomized, single-blind study was conducted between May 2017 and February 2018. Sixty-four rhinoplasty patients were randomly assigned to absorbable (n = 32) or nonabsorbable (n = 32) groups. The columellar incision was closed with 7 full-thickness skin sutures. Either nonabsorbable 6/0 polypropylene (Group 1) or absorbable 6/0 polyglytone 6211 (Group 2) sutures were placed at the columellar incisions. Polypropylene sutures were removed at the 7th postoperative day. A Mann-Whitney U test and Monte Carlo were used for statistical comparison. Photographs of the patients at the postoperative third month (Fig. 2) were evaluated and scored in terms of scarring, pigmentation, notching, level differences in the incision area by two different otorhinolaryngologists who did not know the randomization. Suture removing discomfort was assessed with visual analogue scale scores. A satisfaction survey was filled out by all the patients completing their third month after the operation.
RESULTS


According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively). The mean score on the Wong-Baker scale was 3.19 ± 1.67 in group 1. In the Satisfaction Survey, the average score of the group 1 was 6.90 ± 3.24, while the mean score of the group 2 was 7.062 ± 2.77. There was no statistically significant difference between the two groups (p = 0.715).
CONCLUSIONS


Suturing inverted V transcolumellar incisions with rapid resorbable sutures caused significantly less discomfort but no difference in scarring compared to nonresorbable sutures as evaluated by patients and observers.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively).","['Sixty-four rhinoplasty patients', 'May 2017 and February 2018']","['absorbable and nonabsorbable suture materials', 'Polypropylene sutures', 'Rapid Absorbable Sutures with Nonabsorbable Sutures', 'absorbable (n\u2009=\u200932) or nonabsorbable', 'nonabsorbable 6/0 polypropylene (Group 1) or absorbable 6/0 polyglytone 6211 (Group 2) sutures were placed at the columellar incisions']","['Suture removing discomfort', 'scarring', 'discomfort', 'pigmentation, level difference, notching, overall appearance and total score', 'visual analogue scale scores', 'mean score on the Wong-Baker scale']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0491217', 'cui_str': 'Polypropylene suture'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1702173', 'cui_str': 'polyglytone 6211'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",64.0,0.0358099,"According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively).","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Erol', 'Affiliation': 'Department of Otorhinolaryngology, Elmadag Hulusi Alatas State Hospital, Ankara, Turkey. ozzy.erol@gmail.com.'}, {'ForeName': 'Fuat', 'Initials': 'F', 'LastName': 'Buyuklu', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Koycu', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Sabuhi', 'Initials': 'S', 'LastName': 'Jafarov', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Goknil', 'Initials': 'G', 'LastName': 'Gultekin', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Selim S', 'Initials': 'SS', 'LastName': 'Erbek', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01864-2']
1431,32700415,Intermittent pneumatic compression versus additional prophylaxis with enoxaparin for prevention of venous thromboembolism after laparoscopic surgery for gastric and colorectal malignancies: multicentre randomized clinical trial.,"BACKGROUND


The role of antithrombotic chemoprophylaxis in prevention of venous thromboembolism (VTE) in laparoscopic surgery for gastric and colorectal malignancies is unknown. This study compared the addition of enoxaparin following intermittent pneumatic compression (IPC) with IPC alone in patients undergoing laparoscopic surgery for gastrointestinal malignancy.
METHODS


In this multicentre RCT, eligible patients were older than 40 years and had a WHO performance status of 0 or 1. Exclusion criteria were prescription of antiplatelet or anticoagulant drugs and history of VTE. Patients were allocated to IPC or to ICP with enoxaparin in a 1 : 1 ratio. Stratification factors included sex, location of cancer, age 61 years and over, and institution. Enoxaparin was administered on days 1-7 after surgery. Primary outcome was VTE, evaluated by multidetector CT on day 7.
RESULTS


Of 448 patients randomized, 208 in the IPC group and 182 in the IPC with enoxaparin group were evaluated. VTE occurred in ten patients (4·8 per cent) in the IPC group and six (3·3 per cent) in the IPC with enoxaparin group (P = 0·453). Proximal deep vein thrombosis and/or pulmonary embolism occurred in seven patients (3·4 per cent) in the IPC group and one patient (0·5 per cent) in the IPC with enoxaparin group (P = 0·050). All VTE events were asymptomatic and non-fatal. Bleeding occurred in 11 of 202 patients in the IPC with enoxaparin group, and one patient needed a transfusion. All bleeding events were managed by discontinuation of the drug.
CONCLUSION


IPC with enoxaparin after laparoscopic surgery for gastric and colorectal malignancies did not reduce the rate of VTE. Registration number: UMIN000011667 ( https://www.umin.ac.jp/).",2020,Proximal deep vein thrombosis and/or pulmonary embolism occurred in seven patients (3·4 per cent) in the IPC group and one patient (,"['448 patients randomized, 208 in the IPC group and 182 in the IPC with', 'patients undergoing laparoscopic surgery for gastrointestinal malignancy', 'venous thromboembolism after laparoscopic surgery for gastric and colorectal malignancies', 'eligible patients were older than 40\u2009years and had a WHO performance status of 0 or 1']","['IPC', 'ICP with enoxaparin', 'Enoxaparin', 'antithrombotic chemoprophylaxis', 'intermittent pneumatic compression (IPC) with IPC alone', 'Intermittent pneumatic compression versus additional prophylaxis with enoxaparin', 'enoxaparin', 'laparoscopic surgery']","['Proximal deep vein thrombosis and/or pulmonary embolism', 'All bleeding events', 'VTE', 'Bleeding', 'VTE, evaluated by multidetector CT on day 7', 'rate of VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",448.0,0.16477,Proximal deep vein thrombosis and/or pulmonary embolism occurred in seven patients (3·4 per cent) in the IPC group and one patient (,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kamachi', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Homma', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yokota', 'Affiliation': 'Department of Surgery, Sunagawa City Medical Centre, Sunagawa, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Funakoshi', 'Affiliation': 'Department of Surgery, Asahikawa-Kosei General Hospital, Asahikawa, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Gastrointestinal Surgery, National Hospital Organization Hokkaido Cancer Centre, Hokkaido.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Surgical Centre, Hokkaido, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Clinical Research and Medical Innovation Centre, Hokkaido University Hospital, Hokkaido, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Taketomi', 'Affiliation': 'Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.'}]",BJS open,['10.1002/bjs5.50323']
1432,32705710,Comparison of peritoneal dialysis catheter insertion techniques by nephrologists: Surgical vs blind methods.,"BACKGROUND


The aim of the present study was to perform a comparative analysis of peritoneal dialysis catheter (PDC) insertion between blind and surgical methods by nephrologists.
PATIENTS AND METHODS


The present study enrolled 249 peritoneal dialysis patients who received first-time PDC insertion. All PDC insertions were performed using either the blind or surgical method. In our hospital during the study period, two of three nephrologists performed the blind method routinely in all eligible patients (blind group), and one of three nephrologists performed the surgical method in all eligible patients (surgical group). Catheter outcomes, including infectious or mechanical complications, functional parameters, and catheter survival, were evaluated.
RESULTS


The numbers of patients underwent surgical or blind methods were 105 and 144, respectively. The use of systemic analgesics in the surgical group was higher than that in the blind group. The operation time was longer in the blind group than in the surgical group. The D0 level and peritoneal Kt/V were similar between the two groups. There was no significant difference in infectious and mechanical complications between the two groups. The catheter survival and intervention-free survival were similar between the two groups (P = .995 for catheter survival and P = .723 for intervention-free survival).
CONCLUSION


Our study shows that catheter outcomes are similar between blind and surgical insertion techniques performed by nephrologists. These findings reveal that patients without previous major abdominal surgery would be suitable to receive any one of the two methods according to the operator-friendly technique.",2020,The catheter survival and intervention-free survival were similar between the two groups (P = .995 for catheter survival and P = ,"['249 peritoneal dialysis patients who received first-time PDC insertion', 'patients without previous major abdominal surgery']","['peritoneal dialysis catheter insertion techniques', 'peritoneal dialysis catheter (PDC) insertion']","['infectious or mechanical complications, functional parameters, and catheter survival', 'infectious and mechanical complications', 'catheter survival and intervention-free survival', 'D0 level and peritoneal', 'operation time']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179783', 'cui_str': 'Peritoneal dialysis catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0179783', 'cui_str': 'Peritoneal dialysis catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",249.0,0.0632112,The catheter survival and intervention-free survival were similar between the two groups (P = .995 for catheter survival and P = ,"[{'ForeName': 'Seok Hui', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Kyu Hyang', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Do', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.'}]",Seminars in dialysis,['10.1111/sdi.12904']
1433,32702651,Evaluation of the efficiency of the web-based epilepsy education program (WEEP) for youth with epilepsy and parents: A randomized controlled trial.,"BACKGROUND


When youth with epilepsy and their parents have insufficient information about the disease, they are known to have more problems with disease management, and they show poor compliance. Providing accurate, reliable, and accessible information with no time and space limitations is extremely important for individuals with epilepsy as well as for their caregivers.
AIM


In this study, we aimed to evaluate the content, quality, usability, and efficacy of our web-based epilepsy education program (WEEP) that we developed for youth with epilepsy and their parents.
METHODS


The sample of this randomized controlled trail was composed of youth with epilepsy who were between the ages of 9 and 18 years and their parents who had applied to the Pediatric Neurology Unit of a tertiary healthcare hospital in Turkey between November 2017 and April 2018. This study was conducted in two stages: (1) the preparation phase, during which we developed a WEEP for epilepsy, and tested its content, quality, and usability; and (2) the implementation phase, during which we evaluated the efficacy of the website by assessing users' knowledge of epilepsy, seizure self-efficacy, attitudes, and e-health literacy. Before the implementation phase, data collection tools were used to test the prior knowledge of epilepsy of the participants and control groups. Next, the youth and their parents were asked to use the WEEP for 12 weeks, while a control group was not provided with additional education tools. Written consent was obtained from the participants prior to the study in addition to obtaining approval from the ethics committee and permission from the institution where the research was conducted. The data were finally analyzed using SAS 9.4 software.
RESULTS


During the preparation phase, the website was developed and tested for content, quality, and usability. The WEEP was graded 72.7 ± 3.4 points by experts, 92.4 ± 1.63 by youth with epilepsy, and 92.31 ± 1.94 by the parents. During the implementation phase, the efficacy of the web site was evaluated through the assessment of participants' scores. We found that the mean knowledge, seizure self-efficacy, attitude, and e-health literacy scores of youth with epilepsy in the experimental group had significantly increased after the WEEP (p < 0.05). An increase in the scores of knowledge, anxiety, self-management, and e-health literacy scale was also found among the parents in the intervention group (p < 0.05).
CONCLUSION


The content, quality, and usability of the WEEP were adequate and effective in improving knowledge, self-efficacy, attitudes, and e-health literacy of youth with epilepsy as well as those of their parents.",2020,"An increase in the scores of knowledge, anxiety, self-management, and e-health literacy scale was also found among the parents in the intervention group (p < 0.05).
","['youth with epilepsy who were between the ages of 9 and 18\u202fyears and their parents who had applied to the Pediatric Neurology Unit of a tertiary healthcare hospital in Turkey between November 2017 and April 2018', 'youth with epilepsy and parents', 'youth with epilepsy and their parents']",['web-based epilepsy education program (WEEP'],"['content, quality, and usability of the WEEP were adequate and effective in improving knowledge, self-efficacy, attitudes, and e-health literacy of youth with epilepsy', 'content, quality, usability, and efficacy', ""efficacy of the website by assessing users' knowledge of epilepsy, seizure self-efficacy, attitudes, and e-health literacy"", 'scores of knowledge, anxiety, self-management, and e-health literacy scale', 'mean knowledge, seizure self-efficacy, attitude, and e-health literacy scores of youth with epilepsy']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0279167', 'cui_str': 'Pediatric neurology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0299077,"An increase in the scores of knowledge, anxiety, self-management, and e-health literacy scale was also found among the parents in the intervention group (p < 0.05).
","[{'ForeName': 'Şerife', 'Initials': 'Ş', 'LastName': 'Tutar Güven', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Süleyman Demirel University, Isparta, Turkey. Electronic address: serifeguven@sdu.edu.tr.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'İşler Dalgiç', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Nursing, Akdeniz University, Antalya, Turkey. Electronic address: aisler@akdeniz.edu.tr.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Duman', 'Affiliation': 'Department of Pediatric Neurology, Faculty of Medicine, Akdeniz University, Antalya, Turkey. Electronic address: oduman@akdeniz.edu.tr.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107142']
1434,32706122,Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial.,"AIM


This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle.
METHOD


The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient.
RESULTS


Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A.
INTERPRETATION


The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A.
WHAT THIS PAPER ADDS


Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success.",2020,Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3).,"['severe drooling after one treatment cycle', 'Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective', 'Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y', 'drooling']","['Botulinum neurotoxin', 'botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands', 'botulinum neurotoxin A versus surgery']","['Cost-effectiveness', 'Average costs', 'ICER', 'subjective visual analogue scale for the severity of drooling or the objective drooling quotient', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0038556', 'cui_str': 'Submandibular salivary apparatus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",53.0,0.0603741,Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3).,"[{'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Bekkers', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'van Ulsen', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'M M Adang', 'Affiliation': 'Department for Health Evidence Rehabilitation, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'R T Scheffer', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'J A van den Hoogen', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14636']
1435,32699906,"Effects of MOPP Gear on SAM Medical Junctional Tourniquet Application: A Prospective, Randomized Control Trial.","INTRODUCTION


Hemorrhage is the leading cause of preventable death on the battlefield, and hemostasis is particularly challenging to achieve at junctional sites such as the axillary or inguinal regions. Mission-oriented protective posture (MOPP) gear, as worn most recently in Syria to guard against chemical weapons, can make the performance of technical skills more challenging still. The objective of this study was to evaluate how wearing MOPP gear affects the application time of the SAM Medical Junctional Tourniquet (SJT) by U.S. Army combat medics.
MATERIALS AND METHODS


We conducted a prospective, randomized control trial evaluating time for SJT application between participants wearing MOPP versus those not wearing MOPP. Secondary outcomes included SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items, between groups. Participants placed SJTs on robotic simulation mannequins with a penetrating inguinal injury.
RESULTS


In April 2019, we enrolled 49 combat medics. Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3%). Mean SJT application times in seconds were higher among those wearing MOPP versus those who were not (223.1 versus 167.2; 95% confidence interval for difference in means 5.293, 106.374; P = 0.03). Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34). Compared to participants not wearing MOPP, those wearing MOPP agreed that SJT application was difficult (4 versus 3, P = 0.03), what they were wearing affected SJT application (4 versus 2, P = 0.01), and it was difficult to use their hands during SJT application (4 versus 1, P < 0.001).
CONCLUSIONS


Wearing military MOPP gear significantly prolongs the amount of time required for combat medics to apply an SJT on a simulated casualty with a penetrating inguinal injury. This study highlights the importance of incorporating MOPP gear into medical training scenarios to improve skills competency while wearing these protective garments.",2020,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","['SAM Medical Junctional Tourniquet Application', 'participants wearing MOPP versus those not wearing MOPP', 'Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3']","['SAM Medical Junctional Tourniquet (SJT', 'MOPP Gear', 'Mission-oriented protective posture (MOPP']","['SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items', 'Mean SJT application times', 'successful application rate overall']","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.084364,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Naylor', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ahern', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brett C', 'Initials': 'BC', 'LastName': 'Gendron', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'April', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Schauer', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}]",Military medicine,['10.1093/milmed/usaa138']
1436,32706184,"The use of collagen porcine dermal matrix and connective tissue graft with modified coronally advanced tunnel technique in the treatment of multiple adjacent type I gingival recessions: A randomized, controlled clinical trial.","OBJECTIVE


To assess the clinical efficacy and esthetic outcome of porcine-derived dermal collagen matrix in comparison with connective tissue graft in the treatment of multiple adjacent gingival recessions (MAGR), 6 and 12 months after the surgery.
MATERIALS AND METHODS


Twenty patients with bilateral type I MAGR were treated randomly with porcine-derived dermal collagen matrix (test site) or connective tissue graft (control site) in combination with a modified coronally advanced tunnel technique. The primary objectives were to evaluate the mean and complete root coverage. The secondary objectives were to assess keratinized tissue width, gingival thickness gain, and root coverage esthetic score.
RESULTS


Six and 12 months postoperatively, both groups achieved significant improvements in all clinical parameters compared to baseline, with no statistically significant differences between the groups. Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
CONCLUSION


The porcine-derived dermal collagen matrix combined with a modified coronally advanced tunnel technique resulted in satisfactory clinical and esthetic outcomes, which were similar to connective tissue graft.
CLINICAL SIGNIFICANCE


Porcine-derived dermal collagen matrix (XDM) may be proposed as a substitute for connective tissue graft in multiple adjacent recession treatment due to successful root coverage, a significant increase of gingival thickness, and high esthetic outcomes. The clinical benefits for the use of XDM could be: (a) second surgical wound avoidance, (b) patient discomfort decrease, and (c) lower complications' rate.",2020,"Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
","['multiple adjacent type I gingival recessions', 'multiple adjacent gingival recessions (MAGR), 6 and 12\u2009months after the surgery', 'Twenty patients with bilateral type I MAGR']","['porcine-derived dermal collagen matrix (test site) or connective tissue graft (control site) in combination with a modified coronally advanced tunnel technique', 'porcine-derived dermal collagen matrix', 'collagen porcine dermal matrix and connective tissue graft with modified coronally advanced tunnel technique', 'Porcine-derived dermal collagen matrix (XDM']","['mean and complete root coverage', 'keratinized tissue width, gingival thickness gain, and root coverage esthetic score', 'satisfactory clinical and esthetic outcomes', 'Mean root coverage change']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.0471807,"Mean root coverage change (Δ12m - 6 m) was statistically significant between the groups in favor of connective tissue graft, and twice as many patients exhibited a complete coverage of all recessions in the control group than the test group.
","[{'ForeName': 'Dragana L', 'Initials': 'DL', 'LastName': 'Rakasevic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Milinkovic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Sasa M', 'Initials': 'SM', 'LastName': 'Jankovic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ivan A', 'Initials': 'IA', 'LastName': 'Soldatovic', 'Affiliation': 'Institute for Biostatistics, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Zoran M', 'Initials': 'ZM', 'LastName': 'Aleksic', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Natasa S', 'Initials': 'NS', 'LastName': 'Nikolic-Jakoba', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Belgrade, Belgrade, Serbia.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12624']
1437,32706640,"Comprehensive Genomic Analysis in NRG Oncology/RTOG 9802: A Phase III Trial of Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine in High-Risk Low-Grade Glioma.","PURPOSE


NRG Oncology/RTOG 9802 (ClinicalTrials.gov Identifier: NCT00003375) is a practice-changing study for patients with WHO low-grade glioma (LGG, grade II), as it was the first to demonstrate a survival benefit of adjuvant chemoradiotherapy over radiotherapy. This post hoc study sought to determine the prognostic and predictive impact of the WHO-defined molecular subgroups and corresponding molecular alterations within NRG Oncology/RTOG 9802.
METHODS


IDH1/2  mutations were determined by immunohistochemistry and/or deep sequencing. A custom Ion AmpliSeq panel was used for mutation analysis. 1p/19q codeletion and  MGMT  promoter methylation were determined by copy-number arrays and/or Illumina 450K array, respectively. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Hazard ratios (HRs) were calculated using the Cox proportional hazard model and tested using the log-rank test. Multivariable analyses (MVAs) were performed incorporating treatment and common prognostic factors as covariates.
RESULTS


Of the eligible patients successfully profiled for the WHO-defined molecular groups (n = 106/251), 26 (24%) were  IDH- wild type, 43 (41%) were  IDH- mutant/non-codeleted, and 37(35%) were  IDH- mutant/codeleted. MVAs demonstrated that WHO subgroup was a significant predictor of PFS after adjustment for clinical variables and treatment. Notably, treatment with postradiation chemotherapy (PCV; procarbazine, lomustine (CCNU), and vincristine) was associated with longer PFS (HR, 0.32;  P  = .003; HR, 0.13;  P  < .001) and OS (HR, 0.38;  P  = .013; HR, 0.21;  P  = .029) in the  IDH- mutant/non-codeleted and  IDH- mutant/codeleted subgroups, respectively. In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
CONCLUSION


This study is the first to report the predictive value of the WHO-defined diagnostic classification in a set of uniformly treated patients with LGG in a clinical trial. Importantly, this post hoc analysis supports the notion that patients with  IDH -mutant high-risk LGG regardless of codeletion status receive benefit from the addition of PCV.",2020,"In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
","['patients with WHO low-grade glioma (LGG, grade II', 'NRG Oncology/RTOG 9802', 'High-Risk Low-Grade Glioma']","['NRG', 'Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine', 'postradiation chemotherapy (PCV; procarbazine, lomustine (CCNU), and vincristine', 'adjuvant chemoradiotherapy over radiotherapy']","['PFS', 'PFS or OS', 'Progression-free survival (PFS) and overall survival (OS', 'Hazard ratios (HRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",,0.0972708,"In contrast, no significant difference in either PFS or OS was observed with the addition of PCV in the  IDH- wild-type subgroup.
","[{'ForeName': 'Erica H', 'Initials': 'EH', 'LastName': 'Bell', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Shaw', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Barger', 'Affiliation': 'Wayne State University, Detroit, MI.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Bullard', 'Affiliation': 'Triangle Neurosurgery, Raleigh, NC.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Baptist Hospital of Miami, Miami, FL.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Stelzer', 'Affiliation': 'Mid-Columbia Medical Center, The Dalles, OR.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McElroy', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Fleming', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Timmers', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Aline P', 'Initials': 'AP', 'LastName': 'Becker', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Salavaggione', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Ohio State University, Columbus, OH.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Aldape', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Brachman', 'Affiliation': 'Arizona Oncology Services Foundation, Phoenix, AZ.'}, {'ForeName': 'Stanley Z', 'Initials': 'SZ', 'LastName': 'Gertler', 'Affiliation': 'The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Albert D', 'Initials': 'AD', 'LastName': 'Murtha', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Rochester Methodist Hospital, Rochester, MN.'}, {'ForeName': 'Grant K', 'Initials': 'GK', 'LastName': 'Hunter', 'Affiliation': 'Intermountain Medical Center, Murray, UT.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Crocker', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Won', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Chakravarti', 'Affiliation': 'The Ohio State University, Columbus, OH.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02983']
1438,32706261,"Acute mitochondrial antioxidant intake improves endothelial function, antioxidant enzyme activity, and exercise tolerance in patients with peripheral artery disease.","Peripheral artery disease (PAD) is a manifestation of atherosclerosis in the leg arteries, which causes claudication. This may be in part due to vascular mitochondrial dysfunction and excessive reactive oxygen species (ROS) production. A mitochondrial-targeted antioxidant (MitoQ) has been shown to improve vascular mitochondrial function that, in turn, led to improved vascular function in older adults and animal models. However, the roles of vascular mitochondria in vascular function including endothelial function and arterial stiffness in patients with PAD are unknown; therefore, with the use of acute MitoQ intake, this study examined the roles of vascular mitochondria in endothelial function, arterial stiffness, exercise tolerance, and skeletal muscle function in patients with PAD. Eleven patients with PAD received either MitoQ or placebo in a randomized crossover design. At each visit, blood samples, brachial and popliteal artery flow-mediated dilation (FMD), peripheral and central pulse-wave velocity (PWV), blood pressure (BP), maximal walking capacity, time to claudication (COT), and oxygen utility capacity were measured pre- and-post-MitoQ and placebo. There were significant group by time interactions ( P  < 0.05) for brachial and popliteal FMD that both increased by Δ2.6 and Δ3.3%, respectively, and increases superoxide dismutase (Δ0.03 U/mL), maximal walking time (Δ73.8 s), maximal walking distance (Δ49.3 m), and COT (Δ44.2 s). There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity ( P  > 0.05). MitoQ intake may be an effective strategy for targeting the vascular mitochondrial environment, which may be useful for restoring endothelial function, leg pain, and walking time in patients with PAD. NEW & NOTEWORTHY  The results of this study reveal for the first time that acute oral intake of mitochondrial-targeted antioxidant (MitoQ, 80 mg) is effective for improving vascular endothelial function and superoxide dismutase in patients with peripheral artery disease (PAD). Acute MitoQ intake is also effective for improving maximal walking capacity and delaying the onset of claudication in patients with PAD. These findings suggest that the acute oral intake of MitoQ-mediated improvements in vascular mitochondria play a pivotal role for improving endothelial function, the redox environment, and skeletal muscle performance in PAD.",2020,"There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05).","['peripheral artery disease patients', '11 patients with PAD received either', 'patients with PAD']","['Acute mitochondrial antioxidant intake', 'mitochondrial-targeted antioxidant (MitoQ', 'MitoQ or placebo']","['maximal walking time (Δ73.8 s), maximal walking distance', 'superoxide dismutase', 'Peripheral artery disease (PAD', 'time interactions (p<0.05) for brachial and popliteal FMD', 'resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05', 'blood samples, brachial and popliteal artery flow-mediated dilation (FMD), peripheral and central pulse-wave velocity (PWV), blood pressure (BP), maximal walking capacity, time to claudication (COT), and oxygen utility capacity', 'endothelial function, antioxidant enzyme activity, and exercise tolerance']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",11.0,0.183995,"There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05).","[{'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Department of Cellular and Integrative Physiology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Paras K', 'Initials': 'PK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cellular and Integrative Physiology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Iraklis I', 'Initials': 'II', 'LastName': 'Pipinos', 'Affiliation': 'Department of Surgery, University of Nebraska Medical Center, Omaha, Nebraska.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00235.2020']
1439,32706285,Effectiveness of Bath Wipes After Hematopoietic Cell Transplantation: A Randomized Trial.,"Objective:  Bacteremia is a leading cause of morbidity and mortality in children undergoing hematopoietic cell transplantation (HCT). Infections of vancomycin-resistant enterococci (VRE) and multidrug resistant (MDR) gram-negative rods (GNRs) are common in this population. Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  Study Design:  Patients undergoing autologous or allogeneic HCT in a tertiary referral center were randomized to receive experimental or standard bath wipes for 60 days post-HCT. Skin swabs were collected at baseline, discharge, and day +60 post-HCT. The rate of VRE colonization was chosen as the marker for efficacy.  Results:  Experimental bath wipes were well tolerated. Before the study, the rate of colonization with VRE in HCT recipients was 25%. In an interim analysis of 127 children, one (2%) patient in the experimental arm and two (3%) in the standard arm were colonized with VRE. Two (3%) patients had nonmucosal barrier injury bacteremia in the standard arm, with none in the experimental arm. MDR GNRs were not isolated. The trial was halted because the interim analyses indicated equivalent efficacy of the two methods.  Conclusions:  Skin cleansing with silver-containing or standard bath wipes resulted in very low and equivalent rates of bacteremia and colonization with VRE and MDR GNRs in children post-HCT. Future studies in other high-risk populations are needed to confirm these results.",2020,"Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  ","['After Hematopoietic Cell Transplantation', 'children undergoing hematopoietic cell transplantation (HCT', 'Patients undergoing autologous or allogeneic HCT in a tertiary referral center']","['Bath Wipes', 'vancomycin-resistant enterococci (VRE) and multidrug resistant (MDR) gram-negative rods (GNRs', 'Skin cleansing with silver-containing or standard bath wipes', 'experimental or standard bath wipes for 60 days post-HCT']","['rate of colonization with VRE', 'nonmucosal barrier injury bacteremia', 'rate of VRE colonization', 'tolerated']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0314752', 'cui_str': 'Gram-negative bacillus'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",127.0,0.12009,"Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  ","[{'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Kjellin', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Qudeimat', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Browne', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Keerthi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Sunkara', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Guolian', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Winfield', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Giannini', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Maron', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Hayden', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Leung', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Triplett', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220944061']
1440,32708741,Locally Applied Slow-Release of Minocycline Microspheres in the Treatment of Peri-Implant Mucositis: An Experimental In Vivo Study.,"BACKGROUND


The objective of this is preclinical investigation was to evaluate the differential drug sustainability and pharmacodynamic properties of two local minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG).
METHODS


Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs. Each implant was randomly assigned to receive one of the following four treatments: (i) CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only). After inducing peri-implant mucositis, the randomly assigned treatments were administered into the gingival sulcus twice at a 4-week interval using a plastic-tipped syringe. Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations were performed after each administration.
RESULTS


The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days). The efficacy of the applied therapies based on clinical, radiographical and histological analyses were comparable across all treatment groups.
CONCLUSIONS


CA microspheres showed longer carrier and bacteriostatic effect sustainability when compared to PG microspheres, however, longer drug sustainability did not lead to improved treatment outcomes.",2020,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"['Peri-Implant Mucositis', 'Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs']","['Minocycline Microspheres', 'CA microspheres', 'CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only', 'minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG']","['longer carrier and bacteriostatic effect sustainability', 'bacteriostatic effect', 'Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations', 'CA microspheres']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0324306', 'cui_str': 'Beagle'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597265', 'cui_str': 'polyacrylate'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1611701', 'cui_str': 'Cell marker'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}]",,0.0567987,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"[{'ForeName': 'Sung-Wook', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Myong-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong-Won', 'Initials': 'KW', 'LastName': 'Paeng', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong Ae', 'Initials': 'KA', 'LastName': 'Yu', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Chong-Kil', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'Section of Graduate Periodontology, Faculty of Odontology, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12070668']
1441,32702706,"Fitness, Strength and Body Composition during Weight Loss in Women with Clinically Severe Obesity: A Randomised Clinical Trial.","INTRODUCTION


To determine whether combined exercise training with an energy-restricted diet leads to improved physical fitness and body composition when compared to energy restriction alone in free-living premenopausal women with clinically severe obesity.
METHODS


Sixty premenopausal women (BMI of 40.4 ± 6.7) were randomised to energy restriction only (ER) or to exercise plus energy restriction (EXER) for 12 months. Body composition and fitness were measured at baseline, 3, 6 and 12 months.
RESULTS


VO2 peak improved more for EXER compared to ER at 3 (mean difference ± SEM 2.5 ± 0.9 mL ∙ kg-1 ∙ min-1, p = 0.006) and 6 (3.1 ± 1.2 mL ∙ kg-1 ∙ min-1, p = 0.007) but not 12 months (2.3 ± 1.6 mL ∙ kg-1 ∙ min-1, p = 0.15). Muscle strength improved more for EXER compared to ER at all time points. No differences between groups for lean mass were observed at 12 months.
CONCLUSION


Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations. Future research should aim to determine an effective lifestyle approach which can be applied in the community setting for this high-risk group.",2020,"Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations.","['premenopausal women with clinically severe obesity in free-living situations', 'free-living premenopausal women with clinically severe obesity', 'Sixty premenopausal women (BMI of 40.4 ± 6.7', 'Women with Clinically Severe Obesity']","['EXER', 'energy restriction only (ER) or to exercise plus energy restriction (EXER', 'energy restriction alone', 'Combining exercise training with an energy-restricted diet', 'mL', 'combined exercise training']","['Fitness, Strength and Body Composition during Weight Loss', 'Muscle strength', 'lean mass', 'VO2 peak', 'aerobic power, total body mass, fat mass or limit lean body mass loss', 'physical fitness and body composition', 'Body composition and fitness']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",60.0,0.0944376,"Combining exercise training with an energy-restricted diet did not lead to greater aerobic power, total body mass, fat mass or limit lean body mass loss at 12 months when compared to energy restriction alone for premenopausal women with clinically severe obesity in free-living situations.","[{'ForeName': 'Clint T', 'Initials': 'CT', 'LastName': 'Miller', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia, c.miller@deakin.edu.au.'}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Selig', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Rice', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mariee', 'Initials': 'M', 'LastName': 'Grima', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'van den Hoek', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ika Sari', 'Affiliation': 'Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin W', 'Initials': 'GW', 'LastName': 'Lambert', 'Affiliation': 'Human Neurotransmitters and Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Dixon', 'Affiliation': 'Clinical Obesity Research Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}]",Obesity facts,['10.1159/000506643']
1442,32703124,Relative efficiencies of alternative preference-based designs for randomised trials.,"Recent work has shown that outcomes in clinical trials can be affected by which treatment the trial participants would select if they were allowed to do so, and if they do or do not actually receive that treatment. These influences are known as selection and preference effects, respectively. Unfortunately, they cannot be evaluated in conventional, parallel group trials because patient preferences remain unknown. However, several alternative designs have been proposed, to measure and take account of patient preferences. In this paper, we discuss three preference-based designs (the two-stage, fully randomised, and partially randomised designs). In conventional trials, only the treatment effect is estimable, while the preference-based designs have the potential to estimate some or all of the selection and preference effects. The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment. We also discuss the advantages and disadvantages of these designs under different scenarios.",2020,"The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment.",[],[],[],[],[],[],,0.123362,"The relative efficiency of these designs is affected by several factors, including the proportion of participants who are undecided about treatments, or who are unable or unwilling to state a preference; the relative preference rate between the treatments being compared, among patients who do have a preference; and the ratio of patients randomised to each treatment.","[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bian', 'Affiliation': 'Department of Mathematics & Statistics, McMaster University, Hamilton, ON, Canada.'}]",Statistical methods in medical research,['10.1177/0962280220941874']
1443,32707097,"Impact of Workspace Design on Radiation Therapist Technicians' Physical Stressors, Mental Workload, Situation Awareness, and Performance.","PURPOSE


Our purpose was to assess the effect of workspace configuration on radiation therapists' (RTs) physical stressors, mental workload (WL), situational awareness (SA), and performance during routine treatment delivery tasks in a simulated environment.
METHODS AND MATERIALS


Fourteen RTs were randomized to 2 workspace configurations while performing 4 simulated scenarios: current (not ergonomically optimized; n = 7) and enhanced (ergonomically optimized, n = 7). Physical stressors were objectively assessed using a rapid upper limb assessment tool. Mental WL was measured at the end of each simulated scenario subjectively using the NASA Task-Load Index and objectively throughout the scenario using eye-tracking metrics (pupil diameter and blink rate). SA was measured at the end of each simulated scenario subjectively using the situation awareness and review technique. Performance was measured objectively via assessment of time-out compliance, error detection, and procedural compliance. Analysis of variance was used to test the effect of workspace configuration on physical stressors, mental WL, SA, and performance.
RESULTS


The enhanced configuration significantly reduced physical stressors (rapid upper limb assessment; P < .01) and resulted in a higher rate of time-out compliance (P = .01) compared with current workspace configuration. No significant effect on other metrics was measured.
CONCLUSIONS


Our results suggest that an ergonomically designed workspace may minimize physical stressors and improve the performance of RTs.",2020,The enhanced configuration significantly reduced physical stressors (RULA; p<0.01) and resulted in a higher rate of time-out compliance (p=0.01) compared to current workspace configuration.,['14 RTs'],"[""current' (not ergonomically optimized; n=7) and 'enhanced' (ergonomically optimized, n=7) while performing 4 simulated scenarios""]","['time-out compliance, error detection and procedural compliance', 'Mental WL', 'physical stressors, mental WL, SA, and performance', ""Radiation Therapists' (RTs) physical stressors, mental workload (WL), situational awareness (SA), and performance"", 'Physical stressors', 'SA', 'rate of time-out compliance', ""Radiation Therapist Technicians' Physical Stressors, Mental Workload, Situation Awareness and Performance""]","[{'cui': 'C0278604', 'cui_str': 'Radiation therapist'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0278604', 'cui_str': 'Radiation therapist'}]",14.0,0.041535,The enhanced configuration significantly reduced physical stressors (RULA; p<0.01) and resulted in a higher rate of time-out compliance (p=0.01) compared to current workspace configuration.,"[{'ForeName': 'Prithima R', 'Initials': 'PR', 'LastName': 'Mosaly', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: prithimareddy@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Tracton', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Dooley', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Adapa', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Nuamah', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Marks', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Lukasz M', 'Initials': 'LM', 'LastName': 'Mazur', 'Affiliation': 'Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; School of Information and Library Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Practical radiation oncology,['10.1016/j.prro.2020.07.002']
1444,32710485,Friend or foe? Postdivorce hostility among recently divorced individuals.,"High levels of hostility often occur during and postdivorce and may significantly affect the quality of life, parent-child relationships, and social functioning of divorcees. Moreover, hostility may predict aggressive and violent behavior. This study sought to (a) compare average general hostility levels of a large sample of Danish divorcees to the norms of the general adult Danish population, (b) compare general hostility levels between male and female divorcees, and (c) investigate the explanatory value of various sociodemographic and divorce-related factors on postdivorce general hostility and whether these factors differ across gender. Cross-sectional baseline data (N = 1,856) from a larger randomized controlled trial study was used in this study. Normative data from a general sample of Danish adults (N = 2,040) was used for comparisons of hostility levels between our study sample and the Danish background population. This study found that male and female divorcees did not report significantly different hostility levels. However, participants reported significantly higher hostility levels postdivorce than the comparative Danish norm sample. Significant predictors of postdivorce hostility were lower age, lower educational level, infidelity as a reason for divorce, higher degree of postdivorce conflict, worse communication with the former spouse, the former spouse as the initiator of the divorce, and new partner status with neither divorcees having a new partner, or only the former spouse having a new partner. The predictive strength of the factors did not differ across gender. The findings may be especially relevant for interventions targeting problematic outcomes postdivorce (e.g., preventing aggressive behavior).",2020,The predictive strength of the factors did not differ across gender.,"['Normative data from a general sample of Danish adults (N\u2009=\u20092,040']",[],"['hostility levels', 'Postdivorce hostility', 'quality of life, parent-child relationships, and social functioning of divorcees', 'postdivorce hostility', 'hostility levels postdivorce']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0567494,The predictive strength of the factors did not differ across gender.,"[{'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Kjeld', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Camilla S', 'Initials': 'CS', 'LastName': 'Øverup', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cipric', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}, {'ForeName': 'Gert M', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'Department of Public Health, University of Copenhagen, København K, Denmark.'}]",Aggressive behavior,['10.1002/ab.21918']
1445,32716540,Efficacy of Cleaning Methods for Ophthalmic Microscopic Instruments: A Comparison Study.,"The combination of silicone oil and blood is difficult to remove from ophthalmic surgical instruments during cleaning and decontamination processes. We sought to establish the most efficient cleaning procedure for this type of contaminated instrument. We uniformly contaminated microscopic instruments made of titanium alloy and stainless steel with either blood alone or blood and silicone oil. We randomly assigned each instrument to one of four types of cleaning procedures that involved combinations of water, a multi-enzyme detergent, or an alkaline detergent. After completing the designated cleaning procedure, a sterile processing technician used an adenosine triphosphate cleaning verification test to evaluate the cleaning efficacy. When cleaning blood- and silicone oil-contaminated titanium-alloy and stainless-steel instruments, the alkaline detergent immersion followed by a multi-enzyme detergent ultrasonic cleaning yielded the highest cleaning effectiveness score (92.5%), which indicates this was the most effective of the four cleaning procedures that we tested.",2020,"We randomly assigned each instrument to one of four types of cleaning procedures that involved combinations of water, a multi-enzyme detergent, or an alkaline detergent.",[],"['Cleaning Methods', 'silicone oil and blood', 'titanium alloy and stainless steel with either blood alone or blood and silicone oil', 'cleaning procedures that involved combinations of water, a multi-enzyme detergent, or an alkaline detergent']",['cleaning effectiveness score'],[],"[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0076732', 'cui_str': 'titanium alloy (TiAl6V4)'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0011740', 'cui_str': 'Detergent'}]","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0463481,"We randomly assigned each instrument to one of four types of cleaning procedures that involved combinations of water, a multi-enzyme detergent, or an alkaline detergent.","[{'ForeName': 'Wenzhe', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Senguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13105']
1446,32715623,"A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study.","INTRODUCTION


This phase 2b/3 trial examined the effects of plasma exchange (PE) in patients with mild-to-moderate Alzheimer's disease (AD).
METHODS


Three hundred forty-seven patients (496 screened) were randomized (1:1:1:1) into three PE treatment arms with different doses of albumin and intravenous immunoglobulin replacement (6-week period of weekly conventional PE followed by a 12-month period of monthly low-volume PE), and placebo (sham).
RESULTS


PE-treated patients performed significantly better than placebo for the co-primary endpoints: change from baseline of Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL; P = .03; 52% less decline) with a trend for Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog; P = .06; 66% less decline) scores at month 14. Moderate-AD patients (baseline Mini-Mental State Examination [MMSE] 18-21) scored better on ADCS-ADL (P = .002) and ADAS-Cog (P = .05), 61% less decline both. There were no changes in mild-AD patients (MMSE 22-26). PE-treated patients scored better on the Clinical Dementia Rating Sum of Boxes (CDR-sb) (P = .002; 71% less decline) and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (P < .0001; 100% less decline) scales.
DISCUSSION


This trial suggests that PE with albumin replacement could slow cognitive and functional decline in AD, although further studies are warranted.",2020,PE-treated patients scored better on the Clinical Dementia Rating Sum of Boxes (CDR-sb) (P = .002; 71% less decline) and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (P ,"[""patients with mild-to-moderate Alzheimer's disease (AD"", 'Three hundred forty-seven patients (496 screened', ""Alzheimer's disease""]","['albumin and intravenous immunoglobulin replacement', 'plasma exchange (PE', 'plasma exchange with albumin replacement', 'PE with albumin replacement', 'placebo (sham', 'placebo']","['ADCS-ADL', 'Clinical Dementia Rating Sum of Boxes (CDR-sb', ""baseline of Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL"", ""Alzheimer's Disease Assessment Scale-Cognitive Subscale"", ""Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.637549,PE-treated patients scored better on the Clinical Dementia Rating Sum of Boxes (CDR-sb) (P = .002; 71% less decline) and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (P ,"[{'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Research Center and Memory Clinic, Fundació ACE, Institut Català de Neurociències Aplicades - Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'López', 'Affiliation': 'Departments of Neurology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Olazarán', 'Affiliation': 'Neurology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Núñez', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfeffer', 'Affiliation': 'Medical Services, Allied Biomedical Research Institute, Inc., Miami, Florida, USA.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Paricio', 'Affiliation': 'Center for Prevention of Alzheimer´s Disease, Miami Dade Medical Research Institute, Miami, Florida, USA.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Lorites', 'Affiliation': 'Medical Services, L&L Research Choices, Inc., Miami, Florida, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Piñol-Ripoll', 'Affiliation': 'Seizure Disorders Unit, Clinical Neuroscience Research, IRBLleida-Hospital Universitari Santa Maria, Lleida, Spain.'}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Gámez', 'Affiliation': 'Psychiatry Department, Galiz Research, Hialeah, Florida, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Anaya', 'Affiliation': 'Nephrology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Dobri', 'Initials': 'D', 'LastName': 'Kiprov', 'Affiliation': 'Apheresis Care Group and Fresenius Medical Care, San Francisco, California, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lima', 'Affiliation': 'American Red Cross Southern Blood Services Region, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Grifols', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bozzo', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}, {'ForeName': 'Zbigniew M', 'Initials': 'ZM', 'LastName': 'Szczepiorkowski', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': 'Pentara Corporation, Salt Lake City, Utah, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Páez', 'Affiliation': ""Alzheimer's Research Group, Grifols, Barcelona, Spain.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12137']
1447,32715381,Investigation of Safety and Tolerability of ASP3652 Based on Clinical Studies of Cerebrospinal Fluid Transfer After Multiple Doses and Exposure After Single Doses at High Dose Levels.,"INTRODUCTION


The studies described here were conducted to investigate the central nervous system (CNS) transfer of ASP3652, a peripherally acting inhibitor of fatty acid amide hydrolase, after multiple doses at around the anticipated therapeutic dose and the safety, tolerability, and pharmacokinetics after single doses at corresponding supratherapeutic doses in healthy subjects.
METHODS


Study 1 was an open-label multiple dose study in which ASP3652 (300 mg bid) or matching placebo was administered in multiple doses to healthy subjects. Study 2 was a placebo-controlled, randomized 4 × 4 crossover study in which ASP3652 was given as three single ascending doses of ASP3652 (600-1800 mg) or matching placebo to healthy subjects. Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF) (study 1 only), and safety were evaluated.
RESULTS


In study 1, ASP3652 was readily absorbed to reach C max  at 1 h after dosing. AUC tau  and C max  of ASP3652 in CSF were approximately 0.2% and 0.06% of the AUC tau  and C max  in plasma after multiple doses of ASP3652 300 mg bid. At steady state the area under the response-time curve (AURC) from 0 to 12 h and the maximum response for anandamide in plasma were approximately 550-fold and 230-fold higher than those in CSF. In study 2, the C max  and AUC of ASP3652 increased higher than dose proportionally in subjects receiving 600-1800 mg ASP3652. For eCBs, although the AURC increased less than dose proportionally, maximum plasma levels were comparable across all treatment groups. The incidence of adverse events (AEs) was similar across all treatment groups including the placebo group. There was no evidence of CNS-related side effects.
CONCLUSIONS


ASP3652 showed low CNS penetration at the anticipated therapeutic dose and was well tolerable without any CNS-related AEs at supratherapeutic doses, supporting that the drug can be safely tested at the anticipated therapeutic dose.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02034734 for study 1, NCT01815684 for study 2.",2020,"Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF)","['to healthy subjects', 'healthy subjects']","['placebo', 'ASP3652', 'matching placebo', 'ASP3652 (300\xa0mg bid) or matching placebo']","['response-time curve (AURC', 'AUC tau  and C max  of ASP3652 in CSF', 'maximum plasma levels', 'low CNS penetration', 'Cerebrospinal Fluid Transfer', 'C max  and AUC of ASP3652', 'incidence of adverse events (AEs', 'maximum response for anandamide in plasma', 'Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}]",,0.105325,"Levels of ASP3652 and endocannabinoids (eCBs) in plasma, cerebrospinal fluid (CSF)","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. masaomi.takizawa@astellas.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cerneus', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Michon', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Rijnders', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Meijer', 'Affiliation': 'Astellas Pharma Europe B. V., Leiden, The Netherlands.'}, {'ForeName': 'Akiyoshi', 'Initials': 'A', 'LastName': 'Someya', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01451-6']
1448,32716114,"A randomized, double-blind, placebo-controlled, phase 3 study of tivantinib in Japanese patients with MET-high hepatocellular carcinoma.","A previous randomized phase 2 study of hepatocellular carcinoma revealed that the c-Met inhibitor tivantinib as second-line treatment significantly prolonged progression-free survival in a subpopulation whose tumor samples highly expressed c-Met (MET-high). Accordingly, this phase 3 study was conducted to evaluate the efficacy of tivantinib as a second-line treatment for Japanese patients with MET-high hepatocellular carcinoma. This randomized, double-blind, placebo-controlled study was conducted at 60 centers in Japan. Hepatocellular carcinoma patients with one prior sorafenib treatment and those with MET-high tumor samples were eligible for inclusion. Registered patients were randomly assigned to either the tivantinib or placebo group at a 2:1 ratio and were treated with twice-a-day oral tivantinib (120 mg bid) or placebo until the discontinuation criteria were met. The primary endpoint was progression-free survival while the secondary endpoints included overall survival and safety. Between January 2014 and June 2016, 386 patients provided consent, and 195 patients were randomized to the tivantinib (n = 134) or placebo (n = 61) group. Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) mo in the tivantinib and placebo groups, respectively (hazard ratio = 0.74, 95% confidence interval: 0.52-1.04, P = .082). Median overall survival was 10.3 (95% confidence interval: 8.1-11.6) and 8.5 (6.2-11.4) mo in the tivantinib and placebo group, respectively (hazard ratio = 0.82, 95% confidence interval: 0.58-1.15). The most common tivantinib-related grade ≥3 adverse events were neutropenia (31.6%), leukocytopenia (24.8%), and anemia (12.0%). This study did not confirm the significant efficacy of tivantinib as a second-line treatment for Japanese patients with MET-high hepatocellular carcinoma. (NCT02029157).",2020,"Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) months in the tivantinib and placebo groups, respectively (hazard ratio=0.74, 95% confidence interval: 0.52-1.04, p=0.082).","['Between January 2014 and June 2016, 386 patients provided consent, and 195 patients', '60 centers in Japan', 'Japanese patients with MET-high hepatocellular carcinoma', 'Japanese Patients with MET-high Hepatocellular Carcinoma', 'Hepatocellular carcinoma patients with one prior sorafenib treatment and those with MET-high tumor samples were eligible for inclusion']","['tivantinib', 'Placebo', 'tivantinib or placebo', 'placebo']","['Median overall survival', 'neutropenia', 'Median progression-free survival', 'leukocytopenia', 'progression-free survival', 'anemia', 'overall survival and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.681592,"Median progression-free survival was 2.8 (95% confidence interval: 2.7-2.9) and 2.3 (1.5-2.8) months in the tivantinib and placebo groups, respectively (hazard ratio=0.74, 95% confidence interval: 0.52-1.04, p=0.082).","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Department of Gastroenterology and Oncology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yoshiji', 'Affiliation': 'Department of Gastroenterology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hino', 'Affiliation': 'Department of Hepatology and Pancreatology, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Oikawa', 'Affiliation': 'Department of Internal Medicine, Division of Hepatology, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Department of Hepatology, Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yasuchika', 'Affiliation': 'Department of Surgery, Division of Hepatobiliary Pancreatic Surgery and Transplantation, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ido', 'Affiliation': 'Department of Gastroenterology, Kagoshima University Medical and Dental Hospital, Kagoshima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakashima', 'Affiliation': 'R&D Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kyorin University, Tokyo, Japan.'}]",Cancer science,['10.1111/cas.14582']
1449,32711541,Beta alanine supplementation effects on metabolic contribution and swimming performance.,"BACKGROUND


Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim.
METHODS


Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day - 1  of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La - ]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BF incl ).
RESULTS


No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BF incl : 25.02); absolute AnLa (p: 0.002; BF incl : 12.61), fatigue index (p > 0.001; BF incl : 63.25) and total anaerobic participation (p: 0.008; BF incl : 4.89).
CONCLUSIONS


Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn't affect metabolic contribution and performance during 400-m freestyle.",2020,"Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BF incl : 25.02); absolute AnLa (p: 0.002; BF incl : 12.61), fatigue index (p > 0.001; BF incl : 63.25) and total anaerobic participation (p: 0.008; BF incl : 4.89).
",['Thirteen competitive swimmers'],"['Beta alanine supplementation', 'β-alanine or placebo', 'β-alanine supplementation', 'placebo']","['metabolic contribution and swimming performance', 'total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS', 'fatigue index', 'total anaerobic participation', 'metabolic contribution and performance', 'Anaerobic alactic (AnAl) and lactic energy (AnLa', 'total energy demand and TAn']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040854', 'cui_str': 'Triacetoneamine-N-Oxyl'}]",13.0,0.124956,"Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BF incl : 25.02); absolute AnLa (p: 0.002; BF incl : 12.61), fatigue index (p > 0.001; BF incl : 63.25) and total anaerobic participation (p: 0.008; BF incl : 4.89).
","[{'ForeName': 'Matheus Silva', 'Initials': 'MS', 'LastName': 'Norberto', 'Affiliation': 'University of São Paulo, Medicine University of Ribeirão Preto (FMRP-USP), Ribeirão Preto, São Paulo, Brazil. matheus.norberto@usp.br.'}, {'ForeName': 'Ricardo Augusto', 'Initials': 'RA', 'LastName': 'Barbieri', 'Affiliation': 'University of São Paulo, School of Physical Education and sport of Ribeirão Preto (EEFERP-USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Danilo Rodrigues', 'Initials': 'DR', 'LastName': 'Bertucci', 'Affiliation': 'Department of Physical Education, State São Paulo University, (UNESP), Rio Claro, São Paulo, Brazil.'}, {'ForeName': 'Ronaldo Bucken', 'Initials': 'RB', 'LastName': 'Gobbi', 'Affiliation': 'University of São Paulo, School of Physical Education and sport of Ribeirão Preto (EEFERP-USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Zapaterra', 'Initials': 'EZ', 'LastName': 'Campos', 'Affiliation': 'Department of Physical Education, Federal University of Pernambuco, (UFPE), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Alessandrou Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Department of Physical Education, State São Paulo University, (UNESP), Bauru, São Paulo, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'De Freitas', 'Affiliation': 'University of São Paulo, School of Physical Education and sport of Ribeirão Preto (EEFERP-USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Papoti', 'Affiliation': 'University of São Paulo, Medicine University of Ribeirão Preto (FMRP-USP), Ribeirão Preto, São Paulo, Brazil.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00365-6']
1450,32711523,Long-term outcomes (2 and 3.5 years post-intervention) of the INFANT early childhood intervention to improve health behaviors and reduce obesity: cluster randomised controlled trial follow-up.,"BACKGROUND


The few health behavior interventions commencing in infancy have shown promising effects. Greater insight into their longer-term benefits is required. This study aimed to assess post-intervention effects of the Melbourne INFANT Program to child age 5y on diet, movement and adiposity.
METHODS


Two and 3.5y post-intervention follow-up (2011-13; analyses completed 2019) of participants retained in the Melbourne INFANT Program at its conclusion (child age ~ 19 m; 2008-10) was conducted. The Melbourne INFANT Program is a 15-month, six session program delivered within first-time parent groups in Melbourne, Australia, between child age 4-19 m. It involves strategies to help parents promote healthy diet, physical activity and reduced sedentary behavior in their infants. No intervention was delivered during the follow-up period reported in this paper. At all time points height, weight and waist circumference were measured by researchers, children wore Actigraph and activPAL accelerometers for 8-days, mothers reported children's television viewing and use of health services. Children's dietary intake was reported by mothers in three unscheduled telephone-administered 24-h recalls.
RESULTS


Of those retained at program conclusion (child age 18 m, n = 480; 89%), 361 families (75% retention) participated in the first follow-up (2y post-intervention; age 3.6y) and 337 (70% retention) in the second follow-up (3.5y post-intervention; age 5y). At 3.6y children in the intervention group had higher fruit (adjusted mean difference [MD] = 25.34 g; CI 95 :1.68,48.99), vegetable (MD = 19.41; CI 95 :3.15,35.67) and water intake (MD = 113.33; CI 95 :40.42,186.25), than controls. At 5y they consumed less non-core drinks (MD = -27.60; CI 95 :-54.58,-0.62). Sweet snack intake was lower for intervention children at both 3.6y (MD = -5.70; CI 95 :-9.75,-1.65) and 5y (MD = -6.84; CI 95 :-12.47,-1.21). Intervention group children viewed approximately 10 min/day less television than controls at both follow-ups, although the confidence intervals spanned zero (MD = -9.63; CI 95 :-30.79,11.53; MD = -11.34; CI 95 :-25.02,2.34, respectively). There was no evidence for effect on zBMI, waist circumference z-score or physical activity.
CONCLUSIONS


The impact of this low-dose intervention delivered during infancy was still evident up to school commencement age for several targeted health behaviors but not adiposity. Some of these effects were only observed after the conclusion of the intervention, demonstrating the importance of long-term follow-up of interventions delivered during early childhood.
TRIAL REGISTRATION


ISRCTN Register ISRCTN81847050 , registered 7th November 2007.",2020,"At 5y they consumed less non-core drinks (MD = -27.60; CI 95 :-54.58,-0.62).","['child age 18\u2009m, n\u2009', '480; 89%), 361 families (75% retention) participated in the first follow-up (2y post-intervention; age 3.6y) and 337 (70% retention) in the second follow-up (3.5y post-intervention; age 5y']","['Melbourne INFANT Program', 'INFANT early childhood intervention']","[""children's television viewing and use of health services"", 'Sweet snack intake', ""Children's dietary intake"", 'health behaviors and reduce obesity', 'zBMI, waist circumference z-score or physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.173757,"At 5y they consumed less non-core drinks (MD = -27.60; CI 95 :-54.58,-0.62).","[{'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Hesketh', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia. kylieh@deakin.edu.au.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'McNaughton', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Cameron', 'Affiliation': 'Global Obesity Centre (GLOBE), Institute for Health Transformation, School of Health and Social Development, Deakin University, Geelong, Australia.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lioret', 'Affiliation': 'Université de Paris, Research Center in Epidemiology and Biostatistics (CRESS), INSERM, INRA, Paris, France.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Australia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Downing', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Campbell', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00994-9']
1451,32712155,Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study).,"OBJECTIVE


MicroRNAs (miRNAs) are promising biomarkers in ovarian cancer. Their kinetics during treatment might be useful for monitoring disease burden, and guiding treatments in patients treated with peri-operative chemotherapy and interval debulking surgery (IDS).
METHODS


Serial blood samples of patients enrolled in the randomized phase II CHIVA trial, comparing first line carboplatin-paclitaxel +/- nintedanib (NCT01583322) and IDS, were investigated to assess the kinetics of 11 relevant miRNAs. Their prognostic/predictive values regarding the likelihood of complete IDS, and the patient survival, were assessed and compared to those of CA125 kinetics. The selection of the miRNAs (miR-15b-5p, miR-16-5p, miR-20a-5p, miR-21-5p, miR-93-5p, miR-122-5p, miR-150-5p, miR-195-5p, miR-200b-3p, miR-148b-5p and miR-34a-5p) was based on the expression levels found with a large explorative panel, and on the literature data.
RESULTS


756 serial blood samples from 119 patients were analyzed for a total of 8172 miRNA assays, and 1299 CA125 values. The longitudinal kinetics of the miRNA expressions were highly inconsistent, and were not related to CA125 dynamics. The miRNA changes during neoadjuvant treatment were not found associated with RECIST tumor response or IDS outcomes. Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests.
CONCLUSIONS


The longitudinal kinetics of miRNA expressions during neoadjuvant treatment in ovarian cancer patients were inconsistent, and were not found to be associated with tumor burden changes. Although some prognostic value could be discussed, no predictive value regarding tumor responses or IDS quality could be identified.",2020,"Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests.
","['756 serial blood samples from 119 patients were analyzed for a total of 8172 miRNA assays, and 1299 CA125 values', 'ovarian cancer patients', 'Serial blood samples of patients enrolled in the randomized phase II CHIVA trial, comparing first', 'patients treated with peri-operative chemotherapy and interval debulking surgery (IDS']",['line carboplatin-paclitaxel '],"['RECIST tumor response or IDS outcomes', 'OS benefits', 'patient survival']","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",119.0,0.0509418,"Decreases of miR-34a-5p and miR-93-5p were associated with PFS benefit (p = .009) and OS benefits (p < .001), respectively, using univariate tests.
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Robelin', 'Affiliation': ""EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Service d'Oncologie Médicale, CITOHL, Centre Hospitalo-Universitaire Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, France, GINECO, Paris, France. Electronic address: patrick.robelin@chu-lyon.fr.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Tod', 'Affiliation': 'EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Pharmacie, Hôpital de la Croix Rousse, Hospices civils de Lyon, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Colomban', 'Affiliation': 'EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Lachuer', 'Affiliation': 'ProfileXpert, SFR-Est, CNRS UMR-S3453, INSERM US7, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Léon Bérard, Cancérologie médicale - 28 Prom. Léa et Napoléon Bullukian, 69008 Lyon Université Claude Bernard Lyon 1, GINECO, Paris, France.'}, {'ForeName': 'Gaëtan De', 'Initials': 'G', 'LastName': 'Rauglaudre', 'Affiliation': 'Institut Sainte-Catherine, Oncologie radiothérapie, 250 Chemin De Baigne Pieds Cs80005, 84918 Avignon, GINECO, Paris, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse, Oncologie Médicale, 13 Rue du Général Harris 14000 Caen, Université Unicaen, GINECO, Paris, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Chevalier-Place', 'Affiliation': 'Centre Oscar Lambret, Cancérologie gynécologique, 3 Frédéric COMBEMALE 59020 Lille, GINECO, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Combe', 'Affiliation': 'Hôpital Européen Georges Pompidou, Oncologie Médicale, 20 Rue Leblanc, 75015 Paris, GINECO, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': 'Hôpital Privé du Confluent, Oncologie médicale, 4 rue Eric Tabarly 44200 Nantes, GINECO, Paris, France.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Hamizi', 'Affiliation': 'Centre Hospitalier Lyon Sud, Oncologie médicale, 165 Chemin Du Grand Revoyet (CH LYON SUD), 69310 Pierre Benite, GINECO, Paris, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Raban', 'Affiliation': 'Hôpital de la Milétrie, Centre Hospitalier Universitaire de Poitiers, Oncologie médicale, 2 Rue De La Miletrie 86000 Poitiers, GINECO, Paris, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Institut Claudius Regaud, Service de chirurgie oncologique, 1 avenue Irène Joliot-Curie, 31059 Toulouse CEDEX 09, GINECO, Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Oncologie médicale, 14 Avenue De L'Hôpital, 45100 Orléans, GINECO, Paris, France.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Berton-Rigaud', 'Affiliation': 'ICO site René Gauducheau, Oncologie médicale, Boulevard Jacques Monod, 44800 Saint Herblain, GINECO, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Hôpital Cochin, Cancérologie oncologie, 27, Rue du Faubourg Saint Jacques, 75014 Paris, GINECO, Paris, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': 'Institut de cancérologie de lorraine, Alexis Vautrin, Oncologie médicale, 6 avenue de bourgogne 54500 Vandœuvre-lès-Nancy, GINECO, Paris, France.'}, {'ForeName': 'Coraline', 'Initials': 'C', 'LastName': 'Dubot', 'Affiliation': 'Centre RENE HUGUENIN INSTITUT CURIE, Oncologie médicale, 35 Rue Dailly, 92210 Saint Cloud, GINECO, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Institut Gustave Roussy, Département de médecine, 114 rue Edouard Vaillant 94805 VILLEJUIF, GINECO, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Malaurie', 'Affiliation': 'Centre Hospitalier Intercommunal de Créteil, Oncologie Médicale et Radiothérapie, 40 Avenue de Verdun, 94000 Créteil, GINECO, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""EMR3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France, Université de Lyon, Lyon, France; Service d'Oncologie Médicale, CITOHL, Centre Hospitalo-Universitaire Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite, France, GINECO, Paris, France.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.021']
1452,32712560,Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis.,"INTRODUCTION


Pimavanserin is a selective 5-HT 2A  inverse agonist/antagonist approved for treating hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Results from short-term, placebo-controlled studies demonstrated a positive benefit/risk profile. This multi-year, open-label study assessed long-term safety and tolerability of pimavanserin.
METHODS


This was an open-label extension (OLE) study in patients previously completing a double-blind, placebo-controlled study or a previous OLE study. Safety was evaluated from adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality. Durability of response was assessed from the Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS).
RESULTS


Of 459 participants treated in this OLE study (average age 71.2 years), the median duration of treatment was 454 days. Over the entire study period (approximately 11 years), ≥1 AE occurred in 392 (85.4%) patients; the majority were of mild to moderate intensity, with fall (32.0%), urinary tract infection (19.0%), and hallucination (13.7%) most common. Serious AEs occurred in 188 (41.0%) patients, and an AE leading to study termination or dose discontinuation occurred in 133 (29.0%) patients. Sixty-one patients died, 59 (12.9%) during treatment or within 30 days after the last dose of study drug; the observed mortality rate was 6.45 per 100 patient-years of exposure. Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
CONCLUSIONS


Long-term treatment with pimavanserin 34 mg once daily demonstrated a favorable benefit/risk profile with no unexpected safety concerns. Mortality rates suggested no increased risk following long-term treatment.",2020,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[""Parkinson's disease psychosis"", '459 participants treated in this OLE study (average age 71.2 years']","['pimavanserin', 'Pimavanserin', 'placebo']","['adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality', 'Mean scores for the CGI-S scale and CBS', 'Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS', 'urinary tract infection', 'AE leading to study termination or dose discontinuation', 'Serious AEs', 'Mortality rates', 'observed mortality rate', 'median duration of treatment']","[{'cui': 'C3805119', 'cui_str': ""Parkinson's disease psychosis""}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",459.0,0.12366,"Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years).
","[{'ForeName': 'Clive G', 'Initials': 'CG', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, UK. Electronic address: c.ballard@exeter.ac.uk.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kreitzman', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, USA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'I-Yuan', 'Initials': 'IY', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Norton', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demos', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Tihomir V', 'Initials': 'TV', 'LastName': 'Ilic', 'Affiliation': 'Medical Faculty of Military Medical Academy, Belgrade, Serbia.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Azulay', 'Affiliation': 'Timone Hospital, Marseille, France.'}, {'ForeName': 'Joaquim J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.06.026']
1453,32712683,Arthroscopic reduction and internal fixation (ARIF) versus open reduction internal fixation (ORIF) to elucidate the difference for tibial side PCL avulsion fixation: a randomized controlled trial (RCT).,"PURPOSE


To compare the clinical, radiological outcomes, economic and technical differences for ORIF by cancellous screw fixation versus ARIF by double-tunnel suture fixation for displaced tibial-side PCL avulsion fractures.
METHODS


Forty patients with displaced tibial-sided PCL avulsions were operated upon after randomizing them into two groups (20 patients each in the open and arthroscopic group) and followed up prospectively. Assessment included duration of surgery, cost involved, pre- and post-operative functional scores, radiological assessment of union, and posterior laxity using stress radiography and complications.
RESULTS


The mean follow-up period was 33 months (27-42) (open group) and 30 months (26-44) (arthroscopic group). The duration of surgery was significantly larger in the arthroscopic group (47.8 ± 17.9 min) as compared to the open group (33.4 ± 10.1 min). The costs involved were significantly higher in the arthroscopic group (p- 0.01). At final follow-up, knee function in the form of IKDC (International Knee Documentation Committee) evaluation (89.9 ± 4.8-open and 89.3 ± 5.9-arthroscopic) and Lysholm scores (94.2 ± 4.1-open and 94.6 ± 4.1-arthroscopic) had improved significantly with the difference (n.s.) between the two groups. The mean posterior tibial displacement was 5.7 ± 1.8 mm in the open group and 6.3 ± 3.1 mm in the arthroscopic group which was (n.s.). There were two non-unions and one popliteal artery injury in the arthroscopic group.
CONCLUSION


Both ARIF and ORIF for PCL avulsion fractures yield good clinical and radiological outcomes. However, ORIF was better than ARIF in terms of cost, duration of surgery, and complications like non-union and iatrogenic vascular injury.
LEVEL OF EVIDENCE


II.",2020,The costs involved were significantly higher in the arthroscopic group (p- 0.01).,['Forty patients with displaced tibial-sided PCL avulsions'],"['cancellous screw fixation versus ARIF by double-tunnel suture fixation', 'Arthroscopic reduction and internal fixation (ARIF) versus open reduction internal fixation (ORIF']","['duration of surgery', 'duration of surgery, cost involved, pre- and post-operative functional scores, radiological assessment of union, and posterior laxity using stress radiography and complications', 'cost, duration of surgery, and complications like non-union and iatrogenic vascular injury', 'mean posterior tibial displacement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0185044', 'cui_str': 'Surgical avulsion'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C1297885', 'cui_str': 'Open reduction with internal fixation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0301599,The costs involved were significantly higher in the arthroscopic group (p- 0.01).,"[{'ForeName': 'Silvampatti Ramaswamy', 'Initials': 'SR', 'LastName': 'Sundararajan', 'Affiliation': 'Department of Arthroscopy and Sports Medicine, Ganga Medical Centre and Hospitals Pvt Ltd, 313 Mettupalayam Road, Coimbatore, 641043, India. sundarbone70@hotmail.com.'}, {'ForeName': 'Joseph Babu', 'Initials': 'JB', 'LastName': 'Joseph', 'Affiliation': 'Department of Arthroscopy and Sports Medicine, Ganga Medical Centre and Hospitals Pvt Ltd, 313 Mettupalayam Road, Coimbatore, 641043, India.'}, {'ForeName': 'Rajagopalakrishnan', 'Initials': 'R', 'LastName': 'Ramakanth', 'Affiliation': 'Department of Arthroscopy and Sports Medicine, Ganga Medical Centre and Hospitals Pvt Ltd, 313 Mettupalayam Road, Coimbatore, 641043, India.'}, {'ForeName': 'Amit Kumar', 'Initials': 'AK', 'LastName': 'Jha', 'Affiliation': 'Department of Arthroscopy and Sports Medicine, Ganga Medical Centre and Hospitals Pvt Ltd, 313 Mettupalayam Road, Coimbatore, 641043, India.'}, {'ForeName': 'Shanmuganathan', 'Initials': 'S', 'LastName': 'Rajasekaran', 'Affiliation': 'Department of Orthopaedics and Spine Surgery, Ganga Medical Centre and Hospitals Pvt Ltd, 313 Mettupalayam Road, Coimbatore, 641043, India.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06144-9']
1454,32716706,Delayed Denosumab Injections and Fracture Risk Among Patients With Osteoporosis : A Population-Based Cohort Study.,"BACKGROUND


Denosumab is effective for osteoporosis, but discontinuation leads to rapid reversal of its therapeutic effect.
OBJECTIVE


To estimate the risk for fracture among users of denosumab who delayed subsequent doses compared with users who received doses on time.
DESIGN


Population-based cohort study.
SETTING


The Health Improvement Network U.K. primary care database, 2010 to 2019.
PATIENTS


Persons aged 45 years or older who initiated denosumab therapy for osteoporosis.
MEASUREMENTS


Observational data were used to emulate an analysis of a hypothetical trial with 3 dosing intervals: subsequent denosumab injection given within 4 weeks after the recommended date (""on time""), delay by 4 to 16 weeks (""short delay""), and delay by more than 16 weeks (""long delay""). The primary outcome was a composite of all fracture types at 6 months after the recommended date. Secondary outcomes were major osteoporotic fracture, vertebral fracture, hip fracture, and nonvertebral fracture.
RESULTS


Investigators identified 2594 patients initiating denosumab therapy. The risk for composite fracture over 6 months was 27.3 in 1000 for on-time dosing, 32.2 in 1000 for short delay, and 42.4 in 1000 for long delay. Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P  for trend = 0.093). For vertebral fractures, short delay had an HR of 1.48 (CI, 0.58 to 3.79) and long delay an HR of 3.91 (CI, 1.62 to 9.45).
LIMITATION


Dosing schedules were not randomly assigned.
CONCLUSION


Although delayed administration of subsequent denosumab doses by more than 16 weeks is associated with increased risk for vertebral fracture compared with on-time dosing, evidence is insufficient to conclude that fracture risk is increased at other anatomical sites with long delay.
PRIMARY FUNDING SOURCE


National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation.",2020,"Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P  for trend = 0.093).","['Population-based cohort study', '2594 patients initiating denosumab therapy', 'The Health Improvement Network U.K. primary care database, 2010 to 2019', 'Patients With Osteoporosis', 'Persons aged 45 years or older who initiated denosumab therapy for osteoporosis']",[],"['major osteoporotic fracture, vertebral fracture, hip fracture, and nonvertebral fracture', 'composite of all fracture types', 'hazard ratio (HR) for composite fracture', 'risk for vertebral fracture', 'Fracture Risk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2594.0,0.10165,"Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P  for trend = 0.093).","[{'ForeName': 'Houchen', 'Initials': 'H', 'LastName': 'Lyu', 'Affiliation': ""National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation, General Hospital of Chinese PLA, Beijing, China, Xiangya Hospital of Central South University, Changsha, China, and Brigham and Women's Hospital, Boston, Massachusetts (H.L.).""}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.Y., S.K.T.).""}, {'ForeName': 'Sizheng S', 'Initials': 'SS', 'LastName': 'Zhao', 'Affiliation': 'Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom (S.S.Z.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Health Management Center, Xiangya Hospital of Central South University, Changsha, China (J.W.).'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Xiangya Hospital of Central South University, Changsha, China (C.Z.).'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.Y., S.K.T.).""}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (B.Z.L.).'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital of Central South University, and Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China (G.L.).'}, {'ForeName': 'Peifu', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation, General Hospital of Chinese PLA, Beijing, China (P.T.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.H.S.).""}]",Annals of internal medicine,['10.7326/M20-0882']
1455,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1456,32716589,Platform switching in two-implant bar-retained mandibular overdentures: 1-year results from a split-mouth randomized controlled clinical trial.,"OBJECTIVES


The concept of platform switching is widely applied in current implant dentistry; however, the influence on peri-implant bone-level alterations (ΔIBL), especially in the field of implant overdentures (IODs), remains inconclusive. Therefore, the present study aimed to test the alternative hypothesis that there is an equivalent ΔIBLs at platform-switching and platform-matching implant abutments in 2-implant bar-retained IODs.
MATERIALS AND METHODS


Two interforaminal implants were placed in 32 subjects, who were randomly assigned to either an immediate- or a 3-month post-placement loading group. Furthermore, one implant in each subject was randomly assigned to receive a platform-switched abutment (test), and one a platform-matching abutment (control). The implants were splinted with prefabricated, chairside customized bars. ΔIBL was recorded by using customized radiograph holders at implant placement, implant loading, 3 months, 6 months, and 12 months after loading.
RESULTS


After 1 year, equivalent ΔIBL could be identified (test: -0.51 mm ± 0.49 versus control: -0.56 mm ± 0.52; p < .001). ΔIBL increased over time and was more pronounced in the delayed-loaded implants (-0.87 mm ± 0.61) relative to the immediately loaded implants (-0.35 mm ± 0.43; p = .022).
CONCLUSIONS


The prosthetic concept of platform switching does not necessarily lead to reduced bone loss. Immediate-loading of implants, primarily splinted with a bar, might be beneficial regarding peri-implant bone-level alterations over a short-term period.",2020,"Immediate loading of implants, primarily splinted with a bar, might be beneficial regarding peri-implant bone-level changes over a short-term period.",['Two interforaminal implants were placed in 32 subjects'],[],"['ΔIBL', 'bone loss']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",[],"[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",32.0,0.0683944,"Immediate loading of implants, primarily splinted with a bar, might be beneficial regarding peri-implant bone-level changes over a short-term period.","[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Abou-Ayash', 'Affiliation': 'Department of Reconstructive Dentistry and Gerodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Department of Reconstructive Dentistry and Gerodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': 'Department of Prosthodontics, Preclinical Education and Dental Materials Science, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Mericske-Stern', 'Affiliation': 'School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Albrecht', 'Affiliation': 'Private Practice, St. Gallen, Switzerland.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Enkling', 'Affiliation': 'Department of Reconstructive Dentistry and Gerodontology, University of Bern, Bern, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13640']
1457,32716603,The effect of adjuvant oral irrigation on self-administered oral care in the management of peri-implant mucositis: A randomized controlled clinical trial.,"OBJECTIVES


This single-blinded randomized clinical trial evaluated the effect of adjuvant oral irrigation in addition to self-administered oral care on prevalence and severity of peri-implant mucositis.
MATERIAL & METHODS


After randomization, patients suffering from peri-implant mucositis were assigned to the following: Group 1 (control) received oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement. Group 2 and 3 additionally were instructed to use an oral irrigator with either water or 0.06% CHX solution. One implant per patient was considered for examination. Clinical examinations included Probing Depth, Bleeding on Probing (BOP-positive sites), and Modified Plaque and Gingival Index. A surrogate variable (mucositis severity score) was applied measuring severity of disease. Statistical analysis included linear regression models and sensitivity analysis.
RESULTS


Sixty periodontally healthy patients were examined for presence and severity of peri-implant mucositis. 70% of all patients reached complete resolution of disease after 12 weeks. The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3. Average BOP-positive sites were reduced in all groups after 12 weeks (mean change from baseline: group 1: -1.5; group 2: -1.8; group 3: -2.3).
CONCLUSION


Within the limits of the study, adjuvant use of an oral irrigator with 0.06% CHX in addition to mechanical biofilm removal and oral hygiene instruction can reduce the presence and severity of peri-implant mucositis after 12 weeks.",2020,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","['peri-implant mucositis', 'patients suffering from peri-implant mucositis', '60', 'periodontally healthy patients']","['oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement', 'adjuvant oral irrigation', 'oral irrigator with either water or 0.06% CHX solution']","['prevalence of peri-implant mucositis', 'presence and severity of peri-implant mucositis', 'probing depth (PD), bleeding on probing (BOP-positive sites), modified plaque and gingiva-index (mPI, mGI', 'Average BOP-positive sites', 'complete resolution of disease']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0399271', 'cui_str': 'Oral irrigation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0335463', 'cui_str': 'Irrigator'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",60.0,0.0604381,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bunk', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eisenburger', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Häckl', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': 'School of Dentistry and the Charles Perkins Centre, Faculty of Health and Medicine, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Grischke', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}]",Clinical oral implants research,['10.1111/clr.13638']
1458,32718724,Effects of dobutamine and phenylephrine on cerebral perfusion in patients undergoing cerebral bypass surgery: a randomised crossover trial.,"BACKGROUND


Patients undergoing cerebral bypass surgery are prone to cerebral hypoperfusion. Currently, arterial blood pressure is often increased with vasopressors to prevent cerebral ischaemia. However, this might cause vasoconstriction of the graft and cerebral vasculature and decrease perfusion. We hypothesised that cardiac output, rather than arterial blood pressure, is essential for adequate perfusion and aimed to determine whether dobutamine administration resulted in greater graft perfusion than phenylephrine administration.
METHODS


This randomised crossover study included 10 adult patients undergoing cerebral bypass surgery. Intraoperatively, patients randomly and sequentially received dobutamine to increase cardiac index or phenylephrine to increase mean arterial pressure (MAP). An increase of >10% in cardiac index or >10% in MAP was targeted, respectively. Before both interventions, a reference phase was implemented. The primary outcome was the absolute difference in graft flow between the reference and intervention phase. We compared the absolute flow difference between each intervention and constructed a random-effect linear regression model to explore treatment and carry-over effects.
RESULTS


Graft flow increased with a median of 4.1 (inter-quartile range [IQR], 1.7-12.0] ml min -1 ) after dobutamine administration and 3.6 [IQR, 1.3-7.8] ml min -1  after phenylephrine administration (difference -0.6 ml min -1 ; 95% confidence interval [CI], -14.5 to 5.3; P=0.441). There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
CONCLUSIONS


Both dobutamine and phenylephrine increased graft flow during cerebral bypass surgery, without a preference for one method over the other.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register, NL7077 (https://www.trialregister.nl/trial/7077).",2020,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","['Patients undergoing', '10 adult patients undergoing cerebral bypass surgery', 'patients undergoing cerebral bypass surgery']","['cerebral bypass surgery', 'phenylephrine', 'dobutamine', 'dobutamine and phenylephrine']","['mean arterial pressure (MAP', 'graft perfusion', 'arterial blood pressure', 'graft flow', 'cerebral perfusion', 'Graft flow', 'absolute difference in graft flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",10.0,0.476268,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Akkermans', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: a.akkermans@umcutrecht.nl.'}, {'ForeName': 'Judith A R', 'Initials': 'JAR', 'LastName': 'van Waes', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tristan P C', 'Initials': 'TPC', 'LastName': 'van Doormaal', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurosurgery, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Eric E C', 'Initials': 'EEC', 'LastName': 'de Waal', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gabriël J E', 'Initials': 'GJE', 'LastName': 'Rinkel', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'van der Zwan', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Cor J', 'Initials': 'CJ', 'LastName': 'Kalkman', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Wilton A', 'Initials': 'WA', 'LastName': 'van Klei', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.040']
1459,32719231,Comparison of efficacy of potassium titanyl phosphate laser & diode laser in the management of inferior turbinate hypertrophy: A randomized controlled trial.,"Background & objectives


Inferior turbinate hypertrophy (ITH) is a common condition causing nasal obstruction. This study was undertaken to compare the efficacy of potassium titanyl phosphate (KTP) laser and diode laser in the reduction of the turbinate size.
Methods


This randomized controlled trial included 209 patients with ITH. Pre-operative symptoms were assessed based on the Nasal Obstruction Symptom Evaluation (NOSE) score. Diagnostic nasal endoscopy was done to rule out other nasal sinuses. Nasal mucociliary clearance was measured by saccharin transit time (STT). Postoperatively, the NOSE score, STT and complications were assessed at days one and two, at one week, one month and three months.
Results


Of the 209 patients analyzed at day one, the median NOSE score was 50 in the diode group and 40 in the KTP group, and at three months, 15 in the diode group and five in the KTP group. KTP laser showed a 93 per cent improvement in the NOSE score as compared to 77 per cent improvement shown by diode laser group. Among the intra-operative complications, of the 104 patients in the diode group, 6.73 per cent had burning sensation and 91.43 per cent had bleeding, and of 105 patients in the KTP group, 54.29 per cent had burning sensation and 36.54 per cent had bleeding. Among the post-operative complications in the KTP group, 32 and 34 per cent had bloody nasal discharge on days one and two, compared to 12 and 14 per cent in diode group. Crusting was present in 61 and 49 per cent on days one and two in KTP group as compared to 9 and 15 per cent in diode group, respectively. In the KTP group 30 per cent had synechiae as compared to 10 per cent in diode group.
Interpretation & conclusions


KTP laser was more efficacious than diode laser in improving the NOSE scores but with slightly increased rate of complications in early post-operative period. Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.",2020,Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.,"['209 patients with ITH. Pre-operative symptoms', '209 patients analyzed at day one', 'inferior turbinate hypertrophy']","['Diagnostic nasal endoscopy', 'potassium titanyl phosphate laser & diode laser', 'potassium titanyl phosphate (KTP) laser and diode laser', 'diode laser', 'KTP laser', 'KTP']","['Nasal mucociliary clearance', 'NOSE score', 'saccharin transit time (STT', 'burning sensation', 'NOSE scores', 'bloody nasal discharge', 'Crusting', 'mucociliary clearance mechanism', 'bleeding', 'Nasal Obstruction Symptom Evaluation (NOSE) score', 'median NOSE score', 'rate of complications', 'NOSE score, STT and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0392222', 'cui_str': 'Potassium titanyl phosphate laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",209.0,0.070627,Both the lasers impaired the mucociliary clearance mechanism of the nose till three months of post-operative follow up.,"[{'ForeName': 'Subhashini Puducherry', 'Initials': 'SP', 'LastName': 'Ravichandran', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Karthikeyan', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Pradipta Kumar', 'Initials': 'PK', 'LastName': 'Parida', 'Affiliation': 'Department of Otorhinolarngology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Alexander', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Sivaraman', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Saxena', 'Affiliation': 'Department of Otorhinolarngology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_424_18']
1460,32718943,Effect of Low-dose and Standard-dose Aspirin on PGE 2  Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial.,"Low-dose aspirin is recommended by the U.S. Preventive Services Task Force for primary prevention of colorectal cancer in certain individuals. However, broader implementation will require improved precision prevention approaches to identify those most likely to benefit. The major urinary metabolite of PGE 2 , 11α-hydroxy-9,15-dioxo-2,3,4,5-tetranor-prostane-1,20-dioic acid (PGE-M), is a biomarker for colorectal cancer risk, but it is unknown whether PGE-M is modifiable by aspirin in individuals at risk for colorectal cancer. Adults ( N  = 180) who recently underwent adenoma resection and did not regularly use aspirin or NSAIDs were recruited to a double-blind, placebo-controlled, randomized trial of aspirin at 81 or 325 mg/day for 8-12 weeks. The primary outcome was postintervention change in urinary PGE-M as measured by LC/MS. A total of 169 participants provided paired urine samples for analysis. Baseline PGE-M excretion was 15.9 ± 14.6 (mean ± S.D, ng/mg creatinine). Aspirin significantly reduced PGE-M excretion (-4.7 ± 14.8) compared with no decrease (0.8 ± 11.8) in the placebo group ( P  = 0.015; mean duration of treatment = 68.9 days). Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%;  P  = 0.018) or 325 mg/day (-28%;  P  < 0.0001) compared with placebo. In 40% and 50% of the individuals randomized to 81 or 325 mg/day aspirin, respectively, PGE-M reduction reached a threshold expected to prevent recurrence in 10% of individuals. These results support that aspirin significantly reduces elevated levels of PGE-M in those at increased colorectal cancer risk to levels consistent with lower risk for recurrent neoplasia and underscore the potential utility of PGE-M as a precision chemoprevention biomarker. The ASPIRED trial is registered as NCT02394769.",2020,Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%; p=0.018) or 325 mg/day (-28%; p<0.0001) compared to placebo.,"['Individuals with Colorectal Adenomas', 'Adults (N=180) who recently underwent adenoma resection and did not regularly use aspirin or non-steroidal anti-inflammatory drugs', 'individuals at risk for CRC', '169 participants provided paired urine samples for analysis']","['placebo', 'Aspirin', 'Low-dose and Standard-dose Aspirin', 'aspirin']","['Baseline PGE-M excretion', 'recurrence', 'PGE-M excretion', 'PGE-M levels', 'post-intervention change in urinary PGE-M as measured by liquid-chromatography mass spectrometry', 'PGE2 Biosynthesis']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0049896', 'cui_str': 'prostaglandin M'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}]",169.0,0.217073,Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%; p=0.018) or 325 mg/day (-28%; p<0.0001) compared to placebo.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Drew', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madeline M', 'Initials': 'MM', 'LastName': 'Schuck', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marina V', 'Initials': 'MV', 'LastName': 'Magicheva-Gupta', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kathleen O', 'Initials': 'KO', 'LastName': 'Stewart', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Gilpin', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Parziale', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Pond', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Takacsi-Nagy', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Dylan C', 'Initials': 'DC', 'LastName': 'Zerjav', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Chin', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mackinnon Krems', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Meixell', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Colizzo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Carolan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Norman S', 'Initials': 'NS', 'LastName': 'Nishioka', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Staller', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Richter', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Gala', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Garber', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chung', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Yarze', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Zukerberg', 'Affiliation': 'Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrucci', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Rocca', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Patrono', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Ginger L', 'Initials': 'GL', 'LastName': 'Milne', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. achan@mgh.harvard.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0216']
1461,32728734,Using an Adjunctive Treatment to Address Psychological Distress in a National Weight Management Program: Results of an Integrated Pilot Study.,"INTRODUCTION


Obesity is highly comorbid with psychological symptoms in veterans, particularly post-traumatic stress disorder (PTSD), depression, and anxiety. Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs. The MOVE! program aims to increase healthy eating and physical activity to promote weight loss in obese veterans. Adequately addressing psychological barriers is necessary to maximize outcomes in MOVE! for veterans with PTSD, depression, and anxiety. We examined the preliminary outcomes of administering the Healthy Emotions and Improving Health BehavioR Outcomes (HERO) intervention. HERO is adjunctive cognitive-behavioral therapy to MOVE! that addresses PTSD, depression, and anxiety symptom barriers to engagement in physical activity.
MATERIALS AND METHODS


All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas. Participants gave written informed consent before enrollment. Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE! were assigned to the 8-session HERO group or the usual care (UC) group. Veterans completed assessments of PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight at baseline, 8 and 16 weeks post treatment. Changes from baseline to 8- and 16-week follow-up on the self-report and clinician-rated measures were assessed, using independent samples t-tests and analyses of covariance.
RESULTS


At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group. Similarly, at 16 weeks post-treatment, participants in the HERO group continued to experience a significant increase in daily steps taken per day, as well as statistically and clinically significantly lower scores on the depression symptom and PTSD symptom severity. Participants in the HERO group also demonstrated significantly higher scores on the physical functioning inventory than participants in the UC group (44.1 ± 12.1 vs. 35.7 ± 10.7, P = 0.04) at 16 weeks post treatment.
CONCLUSIONS


Findings of this small trial have important implications pending replication in a more rigorously designed large-scale study. Providing an adjunctive treatment to MOVE! that addresses psychological distress has potential benefits for psychological symptom reduction, engagement in healthy dietary habits, and greater physical activity for individuals who traditionally experience barriers to making positive weight management changes.",2020,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","['Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE', 'Psychological Distress in a National Weight Management Program', 'All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas', 'Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs', 'obese veterans', 'veterans with PTSD, depression, and anxiety']","['HERO', '8-session HERO group or the usual care (UC']","['Health BehavioR', 'PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight', 'physical functioning inventory', 'healthy eating and physical activity', 'daily steps', 'depression symptom and PTSD symptom severity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0035170', 'cui_str': 'Research and Development'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0176149,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Evans-Hudnall', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030.'}, {'ForeName': 'Mary O', 'Initials': 'MO', 'LastName': 'Odafe', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'William S. Middleton Veterans Affairs Hospital, 2500 Overlook Terrace, Madison, WI 53705.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Armenti', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lawson', 'Affiliation': 'Department of Counseling Psychology, University of North Texas, 1155 Union Circle #311280, Denton, Texas 76203-5017.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Trahan', 'Affiliation': 'Trahan Counseling, 631 Mill Street, Suite 101 San Marcos, Texas 78666.'}, {'ForeName': 'Fenan S', 'Initials': 'FS', 'LastName': 'Rassu', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}]",Military medicine,['10.1093/milmed/usaa145']
1462,32723679,Bevacizumab plus fosbretabulin in recurrent ovarian cancer: Overall survival and exploratory analyses of a randomized phase II NRG oncology/gynecologic oncology group study.,"OBJECTIVE


To explore the relationship between tumor size and response to combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab, and the tubulin-binding vascular disrupting agent, fosbretabulin.
METHODS


An exploratory, post-hoc analysis of the randomized phase II trial, Gynecologic Oncology Group-0186I, was performed. One hundred and seven patients with recurrent ovarian carcinoma, treated with up to 3 prior regimens, were randomized to bevacizumab 15 mg/kg body weight with or without intravenous fosbretabulin 60 mg/m 2  body surface area every 21 days until progression or unacceptable toxicity. The primary analysis favored the combination (HR 0.69; 95% CI, 0.47-1.00; p = .049) [Monk BJ, et al. J Clin Oncol 2016;34:2279-86]. The Cox proportional hazards model was used to estimate the treatment effect in various subpopulations.
RESULTS


With extended follow-up, the median PFS for bevacizumab plus fosbretabulin was 7.6  months as compared to 4.8  months with bevacizumab alone (HR 0.74; 90% CI, 0.54-1.02). Overall survival was similar in the experimental and control arms (25.2 vs 24.4 mos, respectively, HR 0.85; 90% CI, 0.59-1.22; p = .461). Eighty-one patients had measurable disease and median tumor size was 5.7  cm. In the ≤5.7  cm subgroup, the HR for progression or death was 0.77 (90% CI 0.45-1.31). Patients with tumors >5.7  cm (n = 40) had a HR for progression or death of 0.55; 90% CI, 0.32-0.96; p = .075).
CONCLUSIONS


Although no significant survival benefit was observed, the trend showing a reduced HR for progression or death with increasing tumor size when fosbretabulin is added to bevacizumab compared to bevacizumab alone warrants further study.",2020,"RESULTS


With extended follow-up","['recurrent ovarian cancer', 'One hundred and seven patients with recurrent ovarian carcinoma']","['bevacizumab 15\u202fmg/kg body weight with or without intravenous fosbretabulin 60\u202fmg/m 2  body surface area', 'combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab', 'bevacizumab', 'Bevacizumab plus fosbretabulin']","['survival benefit', 'Overall survival', 'measurable disease and median tumor size', 'HR for progression or death', 'median PFS for bevacizumab plus fosbretabulin']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0560741', 'cui_str': 'mg/kg body weight'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056154', 'cui_str': 'fosbretabulin'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056154', 'cui_str': 'fosbretabulin'}]",107.0,0.0982756,"RESULTS


With extended follow-up","[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine, Division of Gynecologic Oncology, Orange, CA, United States. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY 14263, United States. Electronic address: sillm@nrgoncology.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, United States. Electronic address: aghajanc@MSKCC.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mannel', 'Affiliation': 'The Peggy and Charles Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, 800 NE 10(th) St., SOCC 6043, Oklahoma City, OK 73104, United States. Electronic address: robert-mannel@ouhsc.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': 'Women and Infants Hospital of Rhode Island, 101 Dudley St., Providence, RI 02905, United States. Electronic address: PDiSilvestro@WIHRI.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, 4911 Barnes Jewish Hospital Plaza, St. Louis, MO 63110, United States. Electronic address: mpowell@wustl.edu.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'University of California, Irvine, Division of Gynecologic Oncology, Orange, CA, United States. Electronic address: Leslie.Randall@vcuhealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farley', 'Affiliation': ""Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Pheonix, AZ 85013, United States. Electronic address: John.farley@chw.edu.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': 'Fox Chase Cancer Center, 333 Cottman Ave., Philadelphia, PA 19111, United States. Electronic address: stephen.rubin@fccc.edu.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Arizona Oncology (US Oncology Network), University of Arizona College of Medicine-Phoenix, Creighton University School of Medicine, St. Joseph's Hospital, Phoenix, AZ, United States. Electronic address: Bradley.Monk@usoncology.com.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.015']
1463,32729761,Effects of using standardized patients on nursing students' moral skills.,"BACKGROUND


Nurses and nursing students increasingly confront ethical problems in clinical practice. Moral sensitivity, moral reasoning, and ethical decision-making are therefore important skills throughout the nursing profession. Innovative teaching methods as part of the ethics training of nursing students help them acquire these fundamental skills.
AIM


This study investigated the effects and potential benefits of using standardized patients in ethics education on nursing baccalaureate students' moral sensitivity, moral reasoning, and ethical decision-making by comparing this method with in-class case analyses.
RESEARCH DESIGN


This is a quasi-experimental study.
PARTICIPANTS AND RESEARCH CONTEXT


The sample comprised 89 students in Hacettepe University's Faculty of Nursing. Following lectures describing the theoretical components of ethics, students were randomly assigned to two working groups, one using standardized patients and the other using in-class case analyses. Data were collected using the Moral Sensitivity Questionnaire, Rest's Defining Issues Test, and the Nursing Dilemma Test. All data were analysed using IBM SPSS Statistics Version 23.
ETHICAL CONSIDERATIONS


Ethical approval and official permission were obtained. All participating students completed informed consent forms.
FINDINGS


According to the results, the moral sensitivity of students in the standardized patient group significantly improved over time compared to those in the case analysis group, while the mean scores of students in both groups for moral reasoning and ethical decision-making were not statistically significant.
CONCLUSION


Based on our results, we recommend the use of both standardized patients and case analysis as appropriate teaching methods in ethics education.",2020,"According to the results, the moral sensitivity of students in the standardized patient group significantly improved over time compared to those in the case analysis group, while the mean scores of students in both groups for moral reasoning and ethical decision-making were not statistically significant.
","['Nurses and nursing students', ""89 students in Hacettepe University's Faculty of Nursing""]",[],['moral reasoning and ethical decision-making'],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",[],"[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",89.0,0.0297933,"According to the results, the moral sensitivity of students in the standardized patient group significantly improved over time compared to those in the case analysis group, while the mean scores of students in both groups for moral reasoning and ethical decision-making were not statistically significant.
","[{'ForeName': 'Gulhan Erkus', 'Initials': 'GE', 'LastName': 'Kucukkelepce', 'Affiliation': '162296Adiyaman University, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Dinc', 'Affiliation': '37515Hacettepe University, Turkey.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Elcin', 'Affiliation': '37515Hacettepe University, Turkey.'}]",Nursing ethics,['10.1177/0969733020935954']
1464,32723572,The Influence of Cost Information on Treatment Choice: A Mixed-Methods Study.,"PURPOSE


To test the null hypothesis that exposure to societal cost information does not affect choice of treatment for carpal tunnel syndrome (CTS).
METHODS


We enrolled 304 participants using the Amazon Mechanical Turk platform to complete a survey in which participants were given the choice between carpal tunnel release (CTR) or a less-expensive option (orthosis wear) in a hypothetical mild CTS scenario. Patients were randomized to receive information about the societal cost of CTR (cost cohort) or no cost information (control). The primary outcome was the probability of choosing CTR measured on a 6-point ordinal scale. We employed qualitative content analysis to evaluate participants' rationale for their choice. We also explored agreement with various attitudes toward health care costs on an ordinal scale.
RESULTS


Participants in the cost cohort exhibited a greater probability of choosing surgery than those in the control cohort. The relative risk of choosing surgery after exposure to societal cost information was 1.43 (95% confidence interval, 1.11-1.85). Among participants who had not previously been diagnosed with CTS (n = 232), the relative risk of choosing surgery after exposure to societal cost information was 1.55 (95% confidence interval, 1.17-2.06). Lack of personal monetary responsibility frequently emerged as a theme in those in the cost cohort who chose surgery. The majority (94%) of participants expressed at least some agreement that health care cost is a major problem whereas only 58% indicated that they consider the country's health care costs when making treatment decisions.
CONCLUSIONS


Participants who received societal cost information were more likely to choose the more expensive treatment option (CTR) for mild CTS.
CLINICAL RELEVANCE


Exposure to societal cost information may influence patient decision making in elective hand surgery. A complete understanding of this influence is required prior to implementing processes toward greater cost transparency for diagnostic/treatment options. Sharing out-of-pocket costs with patients may be a beneficial approach because discussing societal cost information alone will likely not improve value of care.",2020,"The relative risk of choosing surgery after exposure to societal cost information was 1.43 (95% confidence interval, 1.11-1.85).","['304 participants using the Amazon Mechanical Turk platform to complete a survey in which participants were given the choice between carpal tunnel release (CTR) or a less-expensive option (orthosis wear) in a hypothetical mild CTS scenario', 'participants who had not previously been diagnosed with CTS (n\xa0= 232', 'carpal tunnel syndrome (CTS']",['information about the societal cost of CTR (cost cohort) or no cost information (control'],"['probability of choosing CTR measured on a 6-point ordinal scale', 'probability of choosing surgery']","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",304.0,0.0815843,"The relative risk of choosing surgery after exposure to societal cost information was 1.43 (95% confidence interval, 1.11-1.85).","[{'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Zhuang', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, Redwood City, CA.'}, {'ForeName': 'Joost T P', 'Initials': 'JTP', 'LastName': 'Kortlever', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School-The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Shapiro', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, Redwood City, CA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Baker', 'Affiliation': 'Department of Health Research and Policy, Stanford University, Redwood City, CA.'}, {'ForeName': 'Alex H S', 'Initials': 'AHS', 'LastName': 'Harris', 'Affiliation': 'Center for Health Care Evaluation, VA Palo Alto Health Care System, Palo Alto, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, Redwood City, CA. Electronic address: rnkamal@stanford.edu.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.05.019']
1465,32729615,Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men.,"BACKGROUND


Altering the temporal distribution of energy intake (EI) and introducing periods of intermittent fasting (IF) exert important metabolic effects. Restricting EI to earlier in the day [early time-restricted feeding (eTRF)] is a novel type of IF.
OBJECTIVES


We assessed the chronic effects of eTRF compared with an energy-matched control on whole-body and skeletal muscle insulin and anabolic sensitivity.
METHODS


Sixteen healthy males (aged 23 ± 1 y; BMI 24.0 ± 0.6 kg·m-2) were assigned to 2 groups that underwent either 2 wk of eTRF (n = 8) or control/caloric restriction (CON:CR; n = 8) diet. The eTRF diet was consumed ad libitum and the intervention was conducted before the CON:CR, in which the diet was provided to match the reduction in EI and body weight observed in eTRF. During eTRF, daily EI was restricted to between 08:00 and 16:00, which prolonged the overnight fast by ∼5 h. The metabolic responses to a carbohydrate/protein drink were assessed pre- and post-interventions following a 12-h overnight fast.
RESULTS


When compared with CON:CR, eTRF improved whole-body insulin sensitivity [between-group difference (95% CI): 1.89 (0.18, 3.60); P = 0.03; η2p = 0.29] and skeletal muscle uptake of glucose [between-group difference (95% CI): 4266 (261, 8270) μmol·min-1·kg-1·180 min; P = 0.04; η2p = 0.31] and branched-chain amino acids (BCAAs) [between-group difference (95% CI): 266 (77, 455) nmol·min-1·kg-1·180 min; P = 0.01; η2p = 0.44]. eTRF caused a reduction in EI (∼400 kcal·d-1) and weight loss (-1.04 ± 0.25 kg; P = 0.01) that was matched in CON:CR (-1.24 ± 0.35 kg; P = 0.01).
CONCLUSIONS


Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake. The metabolic benefits of eTRF are independent of its effects on weight loss and represent chronic adaptations rather than the effect of the last bout of overnight fast. This trial was registered at clinicaltrials.gov as NCT03969745.",2020,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","['Sixteen healthy males (aged 23\xa0±\xa01 y', 'healthy men']","['early time-restricted feeding (eTRF', 'CON:CR, eTRF', 'eTRF (n\xa0=\xa08) or control/caloric restriction (CON:CR; n\xa0=\xa08) diet', 'eTRF']","['skeletal muscle glucose and BCAA uptake', 'whole-body insulin sensitivity', 'weight loss', 'branched-chain amino acids (BCAAs', 'skeletal muscle insulin and anabolic sensitivity', 'reduction in EI (∼400 kcal·d-1) and weight loss', 'skeletal muscle uptake of glucose']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",16.0,0.0887892,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Pabla', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mallinson', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa192']
1466,32725073,Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.,"OBJECTIVES


The aim of this study was to determine whether a restrictive compared to a liberal fluid therapy will increase postoperative acute kidney injury (AKI) in patients with severe preeclampsia.
METHODS


A total of 46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia were randomized to liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen during cesarean section. The primary outcome was the development of a postoperative renal dysfunction defined by AKI Network stage ≥1. Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL) were evaluated at postoperative days 1 and 2. ClinicalTrials.gov: NCT02214186.
RESULTS


The rate of postoperative AKI was 43.5% in the liberal fluid group and 43.5% in the restrictive fluid group (p=1.0). Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05). In both groups, serum cystatin C did not change from postoperative day 1 compared to the preoperative period and significantly decreased on postoperative day 2 compared to postoperative day 1 (p<0.05). In the restrictive fluid group, NGAL levels increased on postoperative day 1 compared to the preoperative period (p<0.05) and decreased on postoperative day 2 compared to postoperative day 1 (p<0.05).
CONCLUSION


Among patients with severe preeclampsia, a restrictive fluid regimen during cesarean section was not associated with increased postoperative AKI.",2020,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","['patients with severe preeclampsia', 'Post-Cesarean Acute Kidney Injury in Severe Preeclampsia', '46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia']","[""liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen"", 'Restrictive versus Liberal Fluid Therapy', 'liberal fluid therapy']","['Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL', 'Intraoperative urine output', 'NGAL levels', 'postoperative AKI', 'serum cystatin C', 'rate of postoperative AKI', 'development of a postoperative renal dysfunction defined by AKI Network stage ≥1', 'postoperative acute kidney injury (AKI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",46.0,0.206813,"Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05).","[{'ForeName': 'Wallace Andrino da', 'Initials': 'WAD', 'LastName': 'Silva', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Carlo Victor A', 'Initials': 'CVA', 'LastName': 'Varela', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Aline Macedo', 'Initials': 'AM', 'LastName': 'Pinheiro', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paula Castro', 'Initials': 'PC', 'LastName': 'Scherer', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Rossana P V', 'Initials': 'RPV', 'LastName': 'Francisco', 'Affiliation': 'Departamento de Obstetricia e Ginecologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcelo Luis Abramides', 'Initials': 'MLA', 'LastName': 'Torres', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Carmona', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bliacheriene', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Lúcia C', 'Initials': 'LC', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Nefrologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate (DISC), Universitè degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Luiz Marcelo S', 'Initials': 'LMS', 'LastName': 'Malbouisson', 'Affiliation': 'Departamento de Anestesia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1797']
1467,32725680,Dexamethasone combined metronidazole on mammary duct ectasia and its relationship with serum IL-10 and IL-17.,"AIM


To explore the effect of dexamethasone combined with metronidazole in the treatment of mammary duct ectasia (MDE) and its relationship with changes in serum interleukin-10 (IL-10) and IL-17 expression.
METHODS


One hundred and twenty patients with MDE were divided into two groups randomly, control and observation groups (each n = 60). Another 50 patients with normal physical examination were recruited in the normal group. The expressions of serum IL-10 and IL-17 in three groups before and after treatment were observed. The prediction value of IL-10 and IL-17 in clinical efficacy was evaluated.
RESULTS


Among three groups, the expression of IL-10 in the normal group was the highest (P < 0.001), but the expression of IL-17 was the lowest (P < 0.001). After treatment, the expression of IL-17 in observation group was lower (P < 0.001), the expression of IL-10 was higher (P < 0.05) than that in the control group. The areas under the IL-10 and IL-17 curve were 0.874 and 0.806, respectively.
CONCLUSIONS


Dexamethasone combined with metronidazole can effectively improve the clinical efficacy of MDE patient treatment and serum IL-10 and IL-17 can be used as potential predictors of treatment efficacy.",2020,"After treatment, the expression of IL-17 in observation group was lower (P < 0.001), the expression of IL-10 was higher (P < 0.05) than that in the control group.","['Another 50 patients with normal physical examination were recruited in the normal group', 'mammary duct ectasia (MDE', 'One hundred and twenty patients with MDE']","['dexamethasone', 'metronidazole', 'Dexamethasone', 'Dexamethasone combined metronidazole']","['expressions of serum IL-10 and IL-17', 'expression of IL-17', 'serum interleukin-10 (IL-10) and IL-17 expression', 'expression of IL-10', 'IL-10 and IL-17 curve', 'mammary duct ectasia and its relationship with serum IL-10 and IL-17']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0152442', 'cui_str': 'Mammary duct ectasia'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0152442', 'cui_str': 'Mammary duct ectasia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",120.0,0.0244319,"After treatment, the expression of IL-17 in observation group was lower (P < 0.001), the expression of IL-10 was higher (P < 0.05) than that in the control group.","[{'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Breast Surgery, Maternity and Child Health Care of Zaozhuang, Zaozhuang, China.'}, {'ForeName': 'Yuandong', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Breast Surgery, Maternity and Child Health Care of Zaozhuang, Zaozhuang, China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Breast Surgery, Zaozhuang Hospital of Zaozhuang Mining Group, Zaozhuang, China.'}, {'ForeName': 'Yanshen', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Breast Surgery, Zaozhuang Hospital of Zaozhuang Mining Group, Zaozhuang, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, Maternity and Child Health Care of Zaozhuang, Zaozhuang, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14380']
1468,32721815,Effect of intranasal oxytocin administration on self-other distinction: Modulations by psychological distance and gender.,"Preliminary evidence indicates that intranasal oxytocin (OT) administration modulates one's ability to distinguish oneself from others (i.e., self-other distinction). However, previous findings on this topic are contradictory. The current study addressed this issue by (i) using a novel perceptual matching task examining self-other distinction compared to both close and distant others, and (ii) tentatively exploring potential modulations by gender. In a double-blind, placebo-controlled, randomized OT administration study, 100 participants (50 males and 50 females) were randomized to receive intranasal spray of 24 IU OT or placebo (PL). Afterwards, participants completed a geometry perceptual matching task in which different shapes were paired to the self, a friend, or a stranger. Participants were then asked to judge whether each pair of shapes and labels was correctly matched. The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females. These findings provide insights for debates on the role of OT in self-other distinction by revealing modulations by psychological distance and gender, which have implications for the potential clinical applications of OT.",2020,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.",['100 participants (50 males and 50 females'],"['intranasal spray of 24 IU OT or placebo (PL', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],100.0,0.104773,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, China; School of Psychology, Center for Studies of Psychological Application, and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Xingmei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Xiangru', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cognition, Brain and Health, Institute of Psychology and Behavior, Henan University, Kaifeng, China.'}, {'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shangfeng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yue-Jia', 'Initials': 'YJ', 'LastName': 'Luo', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China. Electronic address: luoyj@szu.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104804']
1469,32721845,Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.,"OBJECTIVE


To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery.
METHODS


Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points.
RESULTS


Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded.
CONCLUSION


It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.",2020,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"['lumbar laminectomy surgery', 'Seventy-four patients undergoing lumbar laminectomy']","['Magnesium', 'placebo', 'magnesium (20\u202fmg/kg iv given as bolus before anesthesia induction followed by 20\u202fmg/kg/h civ until surgery completion) or saline', 'magnesium sulphate', 'magnesium', 'morphine']","['adverse effects', 'time-interval to first rescue analgesia', 'intraoperative remifentanil consumption', 'analgesics consumption and pain scores, and perioperative outcomes', 'postoperative cumulative analgesic consumption over 24\u202fh, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24\u202fh), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points', 'analgesic requirements', 'hemodynamic response', 'Postoperative analgesics consumption', 'Hemodynamic variables and desflurane consumption', 'Demographics, surgery duration, desflurane requirements, and recovery profile', 'VAS scores']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.791883,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: tsaousig@otenet.gr.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Nikopoulou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: anastasian1991@windowslive.com.'}, {'ForeName': 'Ioakeim', 'Initials': 'I', 'LastName': 'Pezikoglou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: makispez@gmail.com.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Birba', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: bsbvasso@yahoo.gr.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: grosoman@otenet.gr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106091']
1470,32726727,Effects of a health education program targeted to Chinese women adhering to their cultural practice of doing the month: A randomized controlled trial.,"BACKGROUND


""Doing the month"" is a prevalent Chinese postpartum custom which is believed to restore health after delivery. However, some traditional practices are potentially harmful for women's health.
OBJECTIVES


To examine the effect of an evidence-based health education program on Chinese postpartum women's adherence to traditional practices of doing the month and the effect of adherence to doing the month on maternal physiological and psychological health.
METHODS


A randomized controlled trial was conducted. During December 2016-July 2017, we recruited postpartum women at a tertiary hospital. Women randomized to the intervention group received evidence-based health education within 1 week after returning home and received a second visit 1 month later. The control group received routine postpartum home visits. Adherence to doing the month was measured by the Adherence to Doing-the-Month Practices questionnaire (ADP). Maternal physical health was measured by the Chair Stand Test and Postpartum Symptom Checklist. Maternal psychological health was measured by the Edinburgh Postnatal Depression Scale (EPDS). Descriptive statistics, t-test, and chi-squared test were used to analyze the differences in scores and symptoms of the two groups.
RESULTS


We recruited 124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study. The ADP score of the intervention group was significantly lower than that of the control group (p < 0.001). The number of participants in the experimental group with poor appetite and indigestion was significantly lower than that of control group. No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
CONCLUSIONS


Evidence-based health education can reduce postpartum women's adherence to some traditional practices of doing the month and improve women's physical health.",2020,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","['During December 2016-July 2017, we recruited postpartum women at a tertiary hospital', '124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study', ""Chinese postpartum women's"", 'Chinese women adhering to their cultural practice of doing the month']","['health education program', 'routine postpartum home visits', 'evidence-based health education program', 'evidence-based health education']","['Edinburgh Postnatal Depression Scale (EPDS', 'poor appetite and indigestion', 'Maternal physical health', 'ADP score', 'Maternal psychological health', 'numbers of symptoms and average EPDS scores', 'Chair Stand Test and Postpartum Symptom Checklist']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",124.0,0.0672713,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","[{'ForeName': 'YanQun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'JuYing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Obstetrics Department of Hubei Maternal and Child Health Hospital, China.'}, {'ForeName': 'XiaoLi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Wuhan University School of Health Sciences, China. Electronic address: yuyun7169@163.com.'}, {'ForeName': 'JinBing', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing, Atlanta, GA, USA.'}]",Midwifery,['10.1016/j.midw.2020.102796']
1471,32727835,Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study.,"OBJECTIVE


The phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868) assessed responses to selected vaccines in ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis.
METHODS


Patients were randomized 2:1 into the OCR group (n = 68; OCR 600 mg) or control group (n = 34; interferon beta or no disease-modifying therapy). All received tetanus toxoid (TT)-containing vaccine, Pneumovax (23-valent pneumococcal polysaccharide vaccine [23-PPV]), and keyhole limpet hemocyanin (KLH). The OCR group was subdivided into OCR1 (n = 33) and OCR2 (n = 35) at randomization. The OCR1 group received Prevnar (13-valent conjugate pneumococcal vaccine) 4 weeks after 23-PPV; the OCR2 and control groups received influenza vaccine. Vaccinations started 12 weeks after OCR initiation (OCR group) or on day 1 (control group).
RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. Positive response rate to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in the OCR and 100% in the control group. Prevnar did not enhance response to pneumococcal serotypes in common with Pneumovax. Humoral response to KLH was decreased in the OCR vs control group. Seroprotection rates at 4 weeks against 5 influenza strains ranged from 55.6% to 80.0% in the OCR2 group and 75.0% to 97.0% in the control group.
CONCLUSION


Peripherally B-cell-depleted OCR recipients mounted attenuated humoral responses to clinically relevant vaccines and the neoantigen KLH, suggesting that use of standard nonlive vaccines while on OCR treatment remains a consideration. For seasonal influenza vaccines, it is recommended to vaccinate patients on OCR because a potentially protective humoral response, even if attenuated, can be expected.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence confirming that the humoral response to nonlive vaccines in patients with relapsing multiple sclerosis after OCR treatment is attenuated compared with untreated or interferon beta-treated patients, but they can still be expected to be protective.
CLINICALTRIALSGOV IDENTIFIER


NCT02545868.",2020,"RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","['patients with multiple sclerosis', 'Patients were randomized 2:1 into Group OCR (n=68', 'ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis']","['interferon-β or no disease-modifying therapy', 'tetanus toxoid (TT)-containing vaccine, Pneumovax® (23-PPV) and keyhole limpet hemocyanin (KLH', 'TT vaccine', 'influenza vaccine', 'OCR2', 'ocrelizumab', 'interferon-β-treated', 'OCR1 received Prevnar® (13-PCV']","['Humoral response to KLH', 'Seroprotection rates', 'Positive response rate', 'vaccine responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071315', 'cui_str': 'Pneumovax'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0305062', 'cui_str': 'tetanus toxoid vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0876134', 'cui_str': 'Prevnar'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0381286,"RESULTS


Positive response rate to TT vaccine at 8 weeks was 23.9% in OCR vs 54.5% in Control.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada. amitbar@pennmedicine.upenn.edu.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Calkwood', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Chognot', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Evershed', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Derrick S', 'Initials': 'DS', 'LastName': 'Robertson', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Stokmaier', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Wendt', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'From the Department of Neurology and Center for Neuroinflammation and Experimental Therapeutics (A.B.-O.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; The Minneapolis Clinic of Neurology (J.C.C.), MN; F. Hoffmann-La Roche Ltd (C.C., J.E., M.M., D.S.), Basel, Switzerland; Central Texas Neurology Consultants (E.J.F.), Round Rock; Genentech, Inc (A.H.), South San Francisco, CA; John McNamara Consulting Ltd (J.M.), Cambridge, UK; Department of Neurology (D.S.R.), Multiple Sclerosis Division, University of South Florida College of Medicine, Tampa; Territory Neurology and Research Institution (J.K.W.), Tucson, AZ; Division of Infectious Diseases (K.L.W.), Oregon Health & Science University, Portland; and University of British Columbia (A.T.), Vancouver, Canada.'}]",Neurology,['10.1212/WNL.0000000000010380']
1472,32737072,Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS.,"OBJECTIVE


To better understand ozanimod's mechanism of action (MOA), we conducted exploratory analyses from a phase 1 study to characterize ozanimod's effect on circulating leukocyte subsets in patients with relapsing multiple sclerosis.
METHODS


An open-label pharmacodynamic study randomized patients to oral ozanimod hydrochloride (HCl) 0.5 (n = 13) or 1 mg/d (n = 11) for ∼12 weeks (including 7-day dose escalation). Circulating leukocyte subsets were quantified using flow cytometry (days 28, 56, and 85) and epigenetic cell counting (days 2, 5, 28, 56, and 85) and compared with baseline (day 1) using descriptive statistics.
RESULTS


Ozanimod caused dose-dependent reductions in absolute lymphocyte counts. Observed by both methodologies, circulating CD19 +  B- and CD3 +  T-cell counts were reduced by >50% with ozanimod HCl 0.5 mg and >75% with 1 mg at day 85. Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85. In the flow cytometry analysis, changes in monocytes, natural killer, and natural killer T cells were minimal. Using epigenetic cell counting, greater reductions for Th17 than T regulatory cells were determined.
CONCLUSION


Ozanimod induced dose-dependent reductions in circulating B- and T-cell counts and differential effects on naive and memory CD4 +  and CD8 +  T cells and CD19 +  B cells. Data characterized with both a novel epigenetic cell-counting method and flow cytometry support ozanimod's MOA.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov NCT02797015.",2020,"Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85.","['patients with relapsing multiple sclerosis', 'relapsing MS']","['sphingosine-1-phosphate receptor modulator ozanimod', 'ozanimod HCl', 'oral ozanimod hydrochloride (HCl']","['circulating CD19 +  B- and CD3 +  T-cell counts', 'Circulating leukocyte subsets', 'absolute lymphocyte counts', 'circulating B- and T-cell counts and differential effects on naive and memory CD4 +  and CD8 +  T cells and CD19 +  B cells', 'CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells', 'changes in monocytes, natural killer, and natural killer T cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C4760638', 'cui_str': 'Sphingosine Receptor Modulators'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C1277786', 'cui_str': 'CD3 T-cell count procedure'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C2350466', 'cui_str': 'Natural Killer T-Cell'}]",,0.0568721,"Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF). sarah.harris@bms.com.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Southworth', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Collin M', 'Initials': 'CM', 'LastName': 'Spencer', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Zamvil', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000839']
1473,32738069,Long-Term Influence of Electrode Array Length on Speech Recognition in Cochlear Implant Users.,"OBJECTIVES/HYPOTHESIS


Results from a prospective trial demonstrated better speech recognition for cochlear implant (CI) recipients implanted with a long lateral wall electrode array compared to subjects with a short array after 1 year of listening experience. As short array recipients may require an extended adaptation period, this study investigated whether differences in speech recognition continued through 4 years of CI use.
STUDY DESIGN


Long-term follow-up of a prospective randomized trial.
METHODS


Subjects were randomized to receive a MED-EL medium (24 mm) or standard (31.5 mm) array. Linear mixed models compared speech recognition between cohorts with word recognition in quiet and sentence recognition in noise at 1, 3, 6, 12, 24, and 48 months postactivation. Postoperative imaging and electric frequency filters were reviewed to assess the influence of frequency-to-place mismatch and angular separation between neighboring contacts, a metric associated with peripheral spectral selectivity.
RESULTS


Long (31.5 mm) array recipients demonstrated superior speech recognition out to 4 years postactivation. There was a significant effect of angular separation between contacts, with more closely spaced contacts associated with poorer speech recognition. There was no significant effect of mismatch, yet this may have been obscured by changes in frequency filters over time.
CONCLUSIONS


Conventional MED-EL CI recipients implanted with 31.5-mm arrays experience better speech recognition than 24-mm array recipients, initially and with long-term listening experience. The benefit conferred by longer arrays in the present cohort can be partially attributed to more widely spaced electrode contacts, presumably a result of reduced channel interaction.
LEVEL OF EVIDENCE


2 Laryngoscope, 2020.",2020,"There was a significant effect of angular separation between contacts, with more closely spaced contacts associated with poorer speech recognition.","['Subjects', 'Cochlear Implant Users']","['Electrode Array Length', 'MED-EL medium', 'Conventional MED-EL CI']","['superior speech recognition', 'poorer speech recognition', 'speech recognition', 'Speech Recognition']","[{'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}]","[{'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.0299567,"There was a significant effect of angular separation between contacts, with more closely spaced contacts associated with poorer speech recognition.","[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Canfarotta', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Dillon', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Buchman', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Buss', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Rooth', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'English R', 'Initials': 'ER', 'LastName': 'King', 'Affiliation': 'Department of Audiology, University of North Carolina Health Care, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Harold C', 'Initials': 'HC', 'LastName': 'Pillsbury', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}, {'ForeName': 'Oliver F', 'Initials': 'OF', 'LastName': 'Adunka', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, The Ohio State University, Columbus, Ohio, U.S.A.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Brown', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28949']
1474,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1475,32725352,Postoperative analgesic efficacy of modified continuous transversus abdominis plane block in laparoscopic colorectal surgery: a triple-blind randomized controlled trial.,"BACKGROUND


The optimal opioid-sparing analgesic regimen following laparoscopic colorectal surgery (LCS) remains uncertain. We sought to determine the efficacy of low-dose bupivacaine infusion via surgeon-inserted modified continuous transversus abdominis plane (mcTAP) catheters after LCS.
METHODS


A parallel-group, placebo-controlled, randomized single-centre trial was conducted between April 2017 and February 2018. Block-of-four randomization and allocation concealment by sequentially-numbered, opaque sealed envelopes were used. Patients, surgeons and assessors were blinded. Fifty-two patients were randomized to receive either 0.2% bupivacaine or saline through mcTAP catheters. A 5 ml bolus followed by a 72 h infusion at 2 ml/h was started, with patient-controlled fentanyl analgesia and oral paracetamol given on demand. Primary outcomes were fentanyl consumptions in the first 24 h, second 24 h, and third 24 h following surgery. Secondary outcomes were pain numeric rating scores, recovery outcomes and complications.
RESULTS


Twenty-five patients in the bupivacaine group and 26 in the control group were analysed. Patients in the bupivacaine group required significantly less fentanyl overall (106.1 vs 484.5 mcg, p < 0.001) and at all time points (first 24 h: 61.0 vs 324.3 mcg, p < 0.001; second 24 h: 36.3 vs 119.0 mcg, p = 0.033; third 24 h: 8.8 vs 41.2, p = 0.030) when compared to placebo. Significantly lower pain scores at rest at 6 h (2.32 vs 4.0, p = 0.002), and 12 h (1.80 vs 3.08, p = 0.011) and on coughing at 6 h (4.56 vs 5.84, p = 0.019), 12 h (3.76 vs 4.96, p = 0.009), and 24 h (3.44 vs 4.24, p = 0.049) as well as significantly lower opioid-related complications such as nausea or vomiting (9 (36%) vs 1 (4%), p = 0.005) were observed in the bupivacaine group. There were no major block-related complications, and recovery outcomes were similar in both groups.
CONCLUSIONS


McTAP block reduces postoperative fentanyl consumption and pain scores after LCS, highlighting its role as a safe and useful opioid-sparing analgesia.
REGISTRATION NUMBER


TCTR20150831001 (Thai Clinical Trials Registry). Full trial protocol can be assessed at https://www.clinicaltrials.in.th/ .",2020,"Significantly lower pain scores at rest at 6 h (2.32 vs 4.0, p = 0.002), and 12 h (1.80 vs 3.08, p = 0.011) and on coughing at 6 h (4.56 vs 5.84, p = 0.019), 12 h (3.76 vs 4.96, p = 0.009), and 24 h (3.44 vs 4.24, p = 0.049) as well as significantly lower opioid-related complications such as nausea or vomiting (9 (36%) vs 1 (4%), p = 0.005) were observed in the bupivacaine group.","['Fifty-two patients', 'laparoscopic colorectal surgery', 'April 2017 and February 2018']","['modified continuous transversus abdominis plane block', 'bupivacaine', 'bupivacaine infusion via surgeon-inserted modified continuous transversus abdominis plane (mcTAP) catheters', 'paracetamol', 'McTAP block', 'bupivacaine or saline through mcTAP catheters', 'placebo']","['fentanyl consumptions in the first 24\xa0h, second 24\xa0h, and third 24\xa0h following surgery', 'pain scores', 'coughing', 'pain numeric rating scores, recovery outcomes and complications', 'nausea or vomiting', 'Postoperative analgesic efficacy', 'major block-related complications, and recovery outcomes', 'fentanyl overall', 'postoperative fentanyl consumption and pain scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",52.0,0.543366,"Significantly lower pain scores at rest at 6 h (2.32 vs 4.0, p = 0.002), and 12 h (1.80 vs 3.08, p = 0.011) and on coughing at 6 h (4.56 vs 5.84, p = 0.019), 12 h (3.76 vs 4.96, p = 0.009), and 24 h (3.44 vs 4.24, p = 0.049) as well as significantly lower opioid-related complications such as nausea or vomiting (9 (36%) vs 1 (4%), p = 0.005) were observed in the bupivacaine group.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Haruethaivijitchock', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Ng', 'Affiliation': 'Department of Colorectal Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Taksavanitcha', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Theerawatanawong', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rattananupong', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lohsoonthorn', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sahakitrungruang', 'Affiliation': 'Colorectal Surgery Division, Department of Surgery, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Pathumwan, Bangkok, 10330, Thailand. chucheep@hotmail.com.'}]",Techniques in coloproctology,['10.1007/s10151-020-02311-9']
1476,32725682,The efficacy of medical treatment for adenomyosis after adenomyomectomy.,"AIMS


To compare the efficacy of gonadotropin-releasing hormone agonist (GnRH-a) and GnRH-a + levonorgestrel-releasing intrauterine system (LNG-IUS) after adenomyomectomy for improved adenomyosis-associated symptoms.
METHODS


Overall, 193 patients with adenomyosis included in this study were categorized into three groups: adenomyomectomy (n = 57, group 1), adenomyomectomy + GnRH-a (n = 83, group 2) and adenomyomectomy + GnRH-a + LNG-IUS (n = 53, group 3). Visual Analog Scale (VAS) scores and uterine volumes were determined to evaluate the severity of adenomyosis. Dysmenorrhea improvement and uterine volume were the main outcomes.
RESULTS


The VAS scores of all patients reduced from 7.3 (6.0, 8.5) to 0 (0, 0.6) at the 6 months after surgery, which were significantly higher in group 1 compared to other groups (P < 0.05). In groups 1, 2 and 3, there were 14, 7 and 4 patients, respectively, who suffered dysmenorrhea recurrence. The mean recurrent-free-survival (RFS) was 51.6 ± 2.4, 58.0 ± 1.2 and 58.3 ± 1.0 months, respectively, which was significantly shorter in group 1 (P < 0.05). The dysmenorrhea recurrences were 26.3%, 6.1%, 5.9% in groups 1, 2 and 3, respectively, at the 36 months, which was significantly higher in group 1 (P < 0.01). Significantly decreased uterine volumes were observed in all patients from 222.2 (147.6, 350.4) to 77.0 (65.9, 94.1) mL (P < 0.05) at the 6 month after surgery.
CONCLUSION


Treatment GnRH-a and LNG-IUS after surgery could significantly reduce the recurrence and prolong the RFS. It seemed that the use of LNG-IUS was beneficial for a lower recurrence in long-term follow-up.",2020,It seemed that the use of LNG-IUS was beneficial for a lower recurrence in long-term follow-up.,['193 patients with adenomyosis'],"['adenomyomectomy\u2009+\u2009GnRH-a', 'gonadotropin-releasing hormone agonist (GnRH-a) and GnRH-a\u2009+\u2009levonorgestrel-releasing intrauterine system (LNG-IUS', 'LNG-IUS', 'adenomyomectomy\u2009+\u2009GnRH', 'adenomyomectomy']","['recurrence and prolong the RFS', 'suffered dysmenorrhea recurrence', 'Dysmenorrhea improvement and uterine volume', 'mean recurrent-free-survival (RFS', 'dysmenorrhea recurrences', 'uterine volumes', 'Visual Analog Scale (VAS) scores and uterine volumes', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341858', 'cui_str': 'Endometriosis of uterus'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",193.0,0.0551487,It seemed that the use of LNG-IUS was beneficial for a lower recurrence in long-term follow-up.,"[{'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Qianwei', 'Initials': 'Q', 'LastName': 'Zhen', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Guoyun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14376']
1477,32725529,Early Free Range-of-Motion Upper Limb Exercises After Mastectomy and Immediate Implant-Based Reconstruction Are Safe and Beneficial: A Randomized Trial.,"BACKGROUND


This study assessed the impact that free range-of-motion (ROM) upper limb exercises 15 or 30 days after mastectomy and immediate implant-based reconstruction has on surgical complications and kinetic-functional recovery.
METHODS


This randomized clinical trial included 60 women who had breast cancer treated with mastectomy and immediate implant or tissue expander reconstruction. The patients initiated the exercises with shoulder ROM limited to 90° the day after surgery. After 2 weeks, the patients were randomized into two groups of 30 patients each: the ""free-range group,"" which permitted shoulder range exercises until limited by pain or wound dehiscence, and the ""limited-range group,"" which maintained shoulder movement restriction at 90° until 30 days after surgery, at which time they also were allowed to perform free-range exercises. The patients underwent evaluations preoperatively, then 7, 15, 30, 60, and 90 days after surgery. The primary outcomes were incidence and prevalence of dehiscence and seroma and incidence of infection and necrosis. The secondary outcomes were shoulder ROM, pain, and upper limb function.
RESULTS


The two groups did not differ in terms of incidence and prevalence of postoperative complications. The patients with free upper limb exercise 15 days after surgery had less pain, greater shoulder amplitude, and better upper limb function than those who had movement restricted to 90° for 30 days.
CONCLUSION


The postoperative protocol with free shoulder ROM on the 15th day after surgery is safe and beneficial in terms of kinetic-functional recovery and pain control for patients after mastectomy and immediate implant-based reconstruction.
CLINICAL TRIALS REGISTER


NCT02480842.",2020,"The patients with free upper limb exercise 15 days after surgery had less pain, greater shoulder amplitude, and better upper limb function than those who had movement restricted to 90° for 30 days.
",['60 women who had breast cancer treated with'],"['free-range group,"" which permitted shoulder range exercises until limited by pain or wound dehiscence, and the ""limited-range group,"" which maintained shoulder movement restriction', 'Motion Upper Limb Exercises', 'Mastectomy and Immediate Implant-Based Reconstruction Are Safe and Beneficial', 'mastectomy and immediate implant or tissue expander reconstruction', 'motion (ROM) upper limb exercises 15 or 30\xa0days after mastectomy and immediate implant-based reconstruction']","['incidence and prevalence of postoperative complications', 'incidence and prevalence of dehiscence and seroma and incidence of infection and necrosis', 'shoulder ROM, pain, and upper limb function', 'pain, greater shoulder amplitude, and better upper limb function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",60.0,0.0751089,"The patients with free upper limb exercise 15 days after surgery had less pain, greater shoulder amplitude, and better upper limb function than those who had movement restricted to 90° for 30 days.
","[{'ForeName': 'Samantha Karlla Lopes', 'Initials': 'SKL', 'LastName': 'de Almeida Rizzi', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil. samyfisio@gmail.com.'}, {'ForeName': 'Cinira Assad Simão', 'Initials': 'CAS', 'LastName': 'Haddad', 'Affiliation': 'Lusíada University Center (UNILUS), Santos, SP, Brazil.'}, {'ForeName': 'Patrícia Santolia', 'Initials': 'PS', 'LastName': 'Giron', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Patrícia Vieira Guedes', 'Initials': 'PVG', 'LastName': 'Figueira', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Estevão', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Elias', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Afonso Celso Pinto', 'Initials': 'ACP', 'LastName': 'Nazário', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Facina', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil.'}]",Annals of surgical oncology,['10.1245/s10434-020-08882-z']
1478,32729896,Randomized study defining the optimum target interlesion distance in ablation index-guided atrial fibrillation ablation.,"AIMS


While the CLOSE protocol proposes a maximally tolerable interlesion distance (ILD) of 6 mm for ablation index ablation index-guided atrial fibrillation (AF) ablation, a target ILD has never been defined. This randomized study sought to establish a target ILD for ablation index-guided AF ablation.
METHODS AND RESULTS


Consecutive patients scheduled for first-time pulmonary vein (PV) isolation (PVI) were randomly assigned to ablation protocols with a target ILD of 5.0-6.0 mm or 3.0-4.0 mm, with the primary endpoint of first-pass PVI. In compliance with the CLOSE protocol, the maximum tolerated ILD was 6.0 mm in both study protocols. A target ablation index of ≥550 (anterior) or ≥400 (posterior) was defined for the '5-6 mm' protocol and ≥500 (anterior) or ≥350 (posterior) for the '3-4 mm' protocol. The study was terminated early for superiority of the '3-4 mm' protocol. Forty-two consecutive patients were randomized and 84 ipsilateral PV pairs encircled according to the study protocol. First-pass PVI was accomplished in 35.0% of the '5-6 mm' group and 90.9% of the '3-4 mm' group (P < 0.0001). Median ILD was 5.2 mm in the '5-6 mm' group and 3.6 mm in the '3-4 mm' group (P < 0.0001). In line with the distinct ablation index targets, median ablation index was lower in the '3-4 mm' group (416 vs. 452, P < 0.0001). While mean procedure time was shorter in the '3-4 mm' group (149 ± 27 vs. 167 ± 33min, P = 0.004), fluoroscopy times did not differ significantly (4.7 ± 2.2 vs. 5.1 ± 1.8 min, P = 0.565).
CONCLUSION


In ablation index-guided AF ablation, an ILD of 3.0-4.0 mm should be targeted rather than 5.0-6.0 mm. Moreover, the lower target ILD may allow for less extensive ablation at each given point.",2020,"In line with the distinct ablation index targets, median ablation index was lower in the '3-4 mm' group (416 vs. 452, P < 0.0001).","['Forty-two consecutive patients were randomized and 84 ipsilateral PV pairs encircled according to the study protocol', 'Consecutive patients scheduled for first-time pulmonary vein (PV) isolation (PVI']",['ablation index-guided atrial fibrillation ablation'],"['mean procedure time', 'fluoroscopy times', 'median ablation index', 'Median ILD', 'maximum tolerated ILD']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0509827,"In line with the distinct ablation index targets, median ablation index was lower in the '3-4 mm' group (416 vs. 452, P < 0.0001).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Cardiology and Angiology, Charité-University Medicine Berlin, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Diaz Ramirez', 'Affiliation': 'Department of Cardiology and Angiology, Charité-University Medicine Berlin, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Baldenhofer', 'Affiliation': 'Department of Cardiology and Angiology, Charité-University Medicine Berlin, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Stangl', 'Affiliation': 'Department of Cardiology and Angiology, Charité-University Medicine Berlin, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Hospital Clínic Atrial Fibrillation Unit (UFA), Arrhythmia Section, Cardiovascular Institute, Hospital Clínic, Universitat de Barcelona, C/Villarroel N° 170, 08036 Barcelona, Catalonia, Spain.'}, {'ForeName': 'Till F', 'Initials': 'TF', 'LastName': 'Althoff', 'Affiliation': 'Department of Cardiology and Angiology, Charité-University Medicine Berlin, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa147']
1479,32730183,Rituximab-CHOP With Early Rituximab Intensification for Diffuse Large B-Cell Lymphoma: A Randomized Phase III Trial of the HOVON and the Nordic Lymphoma Group (HOVON-84).,"PURPOSE


Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become standard of care for patients with diffuse large B-cell lymphoma (DLBCL). This randomized trial assessed whether rituximab intensification during the first 4 cycles of R-CHOP could improve the outcome of these patients compared with standard R-CHOP.
PATIENTS AND METHODS


A total of 574 patients with DLBCL age 18 to 80 years were randomly assigned to induction therapy with 6 or 8 cycles of R-CHOP-14 with (RR-CHOP-14) or without (R-CHOP-14) intensification of rituximab in the first 4 cycles. The primary end point was complete remission (CR) on induction. Analyses were performed by intention to treat.
RESULTS


CR was achieved in 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm (hazard ratio [HR], 0.82; 95% CI, 0.50 to 1.36;  P  = .44). After a median follow-up of 92 months (range, 1-131 months), 3-year failure-free survival was 74% (95% CI, 68% to 78%) in the R-CHOP-14 arm versus 69% (95% CI, 63% to 74%) in the RR-CHOP-14 arm (HR, 1.26; 95% CI, 0.98 to 1.61;  P  = .07). Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15). Overall survival at 3 years was 81% (95% CI, 76% to 85%) in the R-CHOP-14 arm versus 76% (95% CI, 70% to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95% CI, 0.97 to 1.67;  P  = .09). Patients between ages 66 and 80 years experienced significantly more toxicity during the first 4 cycles in the RR-CHOP-14 arm, especially neutropenia and infections.
CONCLUSION


Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.",2020,"Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15).","['574 patients with DLBCL age 18 to 80 years', 'patients with untreated DLBCL', 'patients with diffuse large B-cell lymphoma (DLBCL', 'Large B-Cell Lymphoma']","['Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'Rituximab-CHOP With Early Rituximab']","['neutropenia and infections', 'Progression-free survival', 'Overall survival', 'toxicity', 'complete remission (CR) on induction', '3-year failure-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",574.0,0.114829,"Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15).","[{'ForeName': 'Pieternella Johanna', 'Initials': 'PJ', 'LastName': 'Lugtenburg', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Nully Brown', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Haemato Oncology Foundation for Adults in the Netherlands (HOVON) Data Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': ""D'Amore"", 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Koene', 'Affiliation': 'St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fijnheer', 'Affiliation': 'Meander MC, Amersfoort, the Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'van Esser', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Lara H', 'Initials': 'LH', 'LastName': 'Böhmer', 'Affiliation': 'Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Pruijt', 'Affiliation': ""Jeroen Bosch Hospital, 's Hertogenbosch, the Netherlands.""}, {'ForeName': 'Gregor E', 'Initials': 'GE', 'LastName': 'Verhoef', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Memis Y', 'Initials': 'MY', 'LastName': 'Bilgin', 'Affiliation': 'Admiraal de Ruijter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'van der Burg-de Graauw', 'Affiliation': 'Bravis Hospital, Roosendaal, the Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Oosterveld', 'Affiliation': 'Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Kon-Siong G', 'Initials': 'KG', 'LastName': 'Jie', 'Affiliation': 'Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Thomas Stauffer', 'Initials': 'TS', 'LastName': 'Larsen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marjolein W', 'Initials': 'MW', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University MC, Maastricht, the Netherlands.'}, {'ForeName': 'Maria B', 'Initials': 'MB', 'LastName': 'Leijs', 'Affiliation': 'Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthijs H', 'Initials': 'MH', 'LastName': 'Silbermann', 'Affiliation': 'Tergooi Hospitals, Hilversum, the Netherlands.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Spaarne Gasthuis, Hoofddorp, the Netherlands.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Amsterdam UMC, AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Lidwine W', 'Initials': 'LW', 'LastName': 'Tick', 'Affiliation': 'Maxima Medical Center, Eindhoven, the Netherlands.'}, {'ForeName': 'Rolf E', 'Initials': 'RE', 'LastName': 'Brouwer', 'Affiliation': 'Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'King H', 'Initials': 'KH', 'LastName': 'Lam', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Coreline N', 'Initials': 'CN', 'LastName': 'Burggraaff', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Keizer', 'Affiliation': 'UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Anne I', 'Initials': 'AI', 'LastName': 'Arens', 'Affiliation': 'Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'HOVON Pathology Facility and Biobank, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Otto S', 'Initials': 'OS', 'LastName': 'Hoekstra', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra-Baalbergen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03418']
1480,32737862,"Effectiveness of virtual reality games for falls, postural oscillations, pain and quality of life of individual HAM/TSP: a randomized, controlled, clinical trial.","People with HTLV-1 associated myelopathy or tropical spastic paraparesis (HAM/TSP) have sensorimotor losses and postural instability, resulting in frequent falls. These findings stimulate the use of exercise protocols associated with postural control. This study investigated the effectiveness of a balance training exercise protocol through a virtual game. This is a randomized crossover clinical trial performed in subjects with imbalance disorders (HAM/TSP). To evaluate postural oscillations by baropodometry (total area, anterior, posterior and lateral projection), the Footwork® system was used and by cinemetry (angle of the body, hip and ankle alignment in the lateral view), the CVMob system. In addition, the Brief Pain Inventory and the WHOQoL Bref were used to measure pain intensity and quality of life. Comparison tests of the averages (intra and inter groups) and correlations were applied considering an alpha of 5% and power of 80%. The study was approved by the Ethics Committee of the Catholic University of Salvador and registered in the Clinical Trials database (NCT02877030). The final sample consisted of 26, predominantly female subjects. An increase in the postural oscillations of the control subjects (p < 0.05), a reduction in the occurrence of falls (p = 0.039) and an improvement in the quality of life of the control-test group (p < 0.05) were observed. Virtual game training did not improve the static balance, promoting an increase in postural oscillations. Immediately after the application of the protocol, there was a reduction in fall occurrence and improvement in the quality of life.",2020,"An increase in the postural oscillations of the control subjects (p < 0.05), a reduction in the occurrence of falls (p = 0.039) and an improvement in the quality of life of the control-test group (p < 0.05) were observed.","['People with HTLV-1 associated myelopathy or tropical spastic paraparesis (HAM/TSP', 'subjects with imbalance disorders (HAM/TSP']","['balance training exercise protocol', 'Virtual game training', 'virtual reality games']","['quality of life', 'static balance', 'falls, postural oscillations, pain and quality of life of individual HAM/TSP', 'postural oscillations', 'fall occurrence', 'pain intensity and quality of life', 'occurrence of falls']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020094', 'cui_str': 'Human T-lymphotropic virus 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020094', 'cui_str': 'Human T-lymphotropic virus 1'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0290692,"An increase in the postural oscillations of the control subjects (p < 0.05), a reduction in the occurrence of falls (p = 0.039) and an improvement in the quality of life of the control-test group (p < 0.05) were observed.","[{'ForeName': 'Naiane Araújo', 'Initials': 'NA', 'LastName': 'Patrício', 'Affiliation': 'Doutoranda em Medicina e Saúde pela Universidade Federal da Bahia, Salvador, BA, Brazil. naianearaujopatricio@gmail.com.'}, {'ForeName': 'Diogo Guedes', 'Initials': 'DG', 'LastName': 'Vidal', 'Affiliation': 'Unidade de Investigação em Energia, Ambiente e Saúde (FP-ENAS), Universidade Fernando Pessoa, Porto (Portugal), Colaborador de pesquisa da Escola Bahiana de Medicina e Saúde Pública, Bahia, Brasil.'}, {'ForeName': 'Elen Beatriz', 'Initials': 'EB', 'LastName': 'Pinto', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Salvador, Bahia, Brazil.'}, {'ForeName': 'Katia Nunes', 'Initials': 'KN', 'LastName': 'Sá', 'Affiliation': 'Escola Bahiana de Medicina e Saúde Pública, Salvador, Bahia, Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Universidade Federal do ABC, Sao Bernardo, Sao Paulo, Brazil.'}]",Journal of neurovirology,['10.1007/s13365-020-00880-x']
1481,32742637,The effectiveness of a contingent financial incentive to improve trial follow up; a randomised study within a trial (SWAT).,"Objectives  To evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT).  Methods  A two arm 'Study within a Trial' (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion.  Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate.  Results  A total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm (Difference 3.1%, OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55).  Conclusion  It is unclear if contingent financial incentives increased rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials.",2019,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,['434 participants'],"['contingent financial incentive', ""Trial' (SWAT) embedded within a host RCT (SCIMITAR""]","['CO breath measurement', 'proportion of participants completing a CO breath measurement', 'withdrawing from follow-up after contact and time from assessment due date to completion']",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery'}]",434.0,0.270546,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.21059.2']
1482,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
1483,32723109,User experiences with second-generation 32-gauge × 4 mm vs. thinner comparator pen needles: prospective randomized trial.,"OBJECTIVE


Two similarly designed studies compared user experiences with a second-generation extra-thin-wall, 5-bevel 32 G × 4 mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs.
METHODS


Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies. The investigational 32 G PN was compared with three 33-34 G × 3.5-4 mm PNs in Study 1 and one 34 G × 4 mm PN in Study 2. Participants completed 12 abdominal injections of 0.3 mL sterile saline using insulin pens in 6 pairs, each comprising one investigational 32 G PN and one comparator PN in random order. After each injection pair, participants compared injection pain via relative 150 mm visual analog scale (VAS) and perceived dose delivery force via relative 5 point Likert scale. Adjusted models tested injection pain scores (primary endpoint) for noninferiority and, if met, then for superiority. ClinicalTrials.gov identifiers: NCT03878758 and NCT03878745.
RESULTS


The investigational 32 G PN met noninferiority as well as superiority criteria for less injection pain vs. each comparator ( p  < .01), with adjusted mean relative VAS scores 9.1-17.6 in Study 1 ( n  = 154) and 7.3 in Study 2 ( n  = 55). The investigational 32 G PN was also superior vs. each comparator PN in requiring less relative perceived force to deliver the dose ( p  < .01).
CONCLUSIONS


The investigational 32 G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.",2020,"The investigational 32G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.","['Methods:  Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies']","['second-generation extra-thin-wall, 5-bevel 32Gx4mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs']","['injection pain via relative 150-mm visual analog scale (VAS) and perceived dose delivery force via relative 5-point Likert scale', 'injection pain', 'injection pain scores', 'VAS scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0206417', 'cui_str': 'Peripheral nervous system structure'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.394199,"The investigational 32G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gibney', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitz-Patrick', 'Affiliation': 'Department of Diabetes and Endocrinology, East-West Medical Research Institute, Honolulu, HI, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.'}, {'ForeName': 'Shahista', 'Initials': 'S', 'LastName': 'Whooley', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Global Clinical Development, BD, Franklin Lakes, NJ, USA.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Glezer', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1803248']
1484,32723991,Two-weekly docetaxel in treatment of advanced breast cancer: A preliminary study.,"OBJECTIVE


Three-weekly docetaxel causes a high rate of febrile neutropenia, especially in the Asian population. Two-weekly docetaxel has been shown to reduce rate of febrile neutropenia in castrate-resistant prostate cancer patients. We conducted a preliminary study to investigate the safety of two-weekly docetaxel in advanced breast cancer patients.
METHODS


We recruited 10 patients with advanced breast cancer with ECOG (Eastern Cooperative Oncology Group) performance status score of zero to two, who needed chemotherapy in the first or second-line setting to receive two-weekly docetaxel for 8 cycles. The primary endpoint was safety and secondary endpoints were response rate and progression free survival.
RESULTS


The most reported adverse events were haematological (anaemia 100% and neutropenia 90%). The febrile neutropenia rate was 10%. The overall response rate was 20%. The median progression free survival was 5.0 months.
CONCLUSION


Two-weekly docetaxel may be a reasonable alternative treatment regimen for patients with advanced breast cancer in the first or second-line setting. This regimen is yet to be compared with standard 3-weekly schedule in a phase 3 randomised clinical trial.",2020,The most reported adverse events were haematological (anaemia 100% and neutropenia 90%).,"['10 patients with advanced breast cancer with ECOG (Eastern Cooperative Oncology Group) performance status score of zero to two, who needed chemotherapy in the first or second-line setting to receive two-weekly', 'advanced breast cancer', 'patients with advanced breast cancer in the first or second-line setting', 'castrate-resistant prostate cancer patients', 'advanced breast cancer patients']",['docetaxel'],"['response rate and progression free survival', 'febrile neutropenia', 'median progression free survival', 'overall response rate', 'febrile neutropenia rate', 'rate of febrile neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",10.0,0.0327854,The most reported adverse events were haematological (anaemia 100% and neutropenia 90%).,"[{'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'University of Malaya, Faculty of Medicine, Clinical Oncology Unit, Kuala Lumpur, Malaysia. daiwee@ummc.edu.my.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'Kang', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Medicine, Clinical Oncology Department, Kuala Lumpur, Malaysia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ismail', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Medicine, Clinical Oncology Department, Kuala Lumpur, Malaysia.'}]",The Medical journal of Malaysia,[]
1485,32723992,"Selective laser trabeculoplasty vs. topical medications for step-up treatment in primary open angle glaucoma: comparing clinical effectiveness, quality of life and cost-effectiveness.","INTRODUCTION


The aim of this study was to investigate the clinical effectiveness, health related quality of life (HRQoL) and cost effectiveness of selective laser trabeculoplasty (SLT) compared to topical anti-glaucoma medications in step-up treatment of patients with primary open angle glaucoma (POAG).
METHODS


Seventeen POAG patients with suboptimal IOP control despite pre-existing topical medications were subjected to adjunct SLT (50 applications 180 degrees) or second line medical therapy. Current medications were continued, and patients were followed up for 6 months for degree of intraocular pressure (IOP) lowering. HRQoL was assessed using Glaucoma Quality of Life 36-item (GlauQoL-36), Assessment of Quality of Life-7D (AQoL-7D) and Vision related Quality of Life (VisQoL). Costs involved were calculated and compared to the effect (IOP reduction) achieved in each arm.
RESULTS


Ten patients were in the SLT group and 7 in the topical medication (MED) group. Mean baseline intraocular pressure (IOP) was 18.90±3.48mmHg in SLT group and 15.57±2.23mmHg in MED group. Mean reduction of IOP was 4.30±1.64mmHg in SLT group and 2.71±2.56 mmHg in MED group at 6 months which was not statistically significant (p=0.14) between two groups. All the HRQoL questionnaires did not show significant changes in the groups or between groups when compared baseline with 6-month post treatment (p-values ranging from 0.247 to 0.987). For every 1mmHg reduction in IOP, cost involved in MED group (RM53.61) was 165% of the cost involved in SLT group (RM32.56).
DISCUSSION AND CONCLUSION


This study has shown that SLT was as effective clinically and tolerable as topical anti glaucoma medications and was possibly more cost effective in the step-up treatment of patients with POAG at 6 months follow- up.",2020,All the HRQoL questionnaires did not show significant changes in the groups or between groups when compared baseline with 6-month post treatment (p-values ranging from 0.247 to 0.987).,"['primary open angle glaucoma', 'patients with primary open angle glaucoma (POAG', 'Ten patients were in the SLT group and 7 in the topical medication (MED) group', 'Seventeen POAG patients with suboptimal IOP control despite pre-existing topical medications were subjected to']","['SLT', 'adjunct SLT (50 applications 180 degrees) or second line medical therapy', 'topical anti-glaucoma medications', 'selective laser trabeculoplasty (SLT', 'Selective laser trabeculoplasty vs. topical medications']","['Mean baseline intraocular pressure (IOP', 'clinical effectiveness, quality of life and cost-effectiveness', 'HRQoL questionnaires', 'Glaucoma Quality of Life 36-item (GlauQoL-36), Assessment of Quality of Life-7D (AQoL-7D) and Vision related Quality of Life (VisQoL', 'clinical effectiveness, health related quality of life (HRQoL) and cost effectiveness', 'Costs', 'Mean reduction of IOP']","[{'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",10.0,0.0306101,All the HRQoL questionnaires did not show significant changes in the groups or between groups when compared baseline with 6-month post treatment (p-values ranging from 0.247 to 0.987).,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Yong', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Medicine, Department of Ophthalmology, Kuala Lumpur, Malaysia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Che Hamzah', 'Affiliation': 'Universiti Kebangsaan Malaysia, Faculty of Medicine, Department of Ophthalmology, Kuala Lumpur, Malaysia. jemaima@ppukm.ukm.edu.my.'}]",The Medical journal of Malaysia,[]
1486,32728820,Exercise training improves vascular function in patients with Alzheimer's disease.,"PURPOSE


Vascular dysfunction has been demonstrated in patients with Alzheimer's disease (AD). Exercise is known to positively affect vascular function. Thus, the aim of our study was to investigate exercise-induced effects on vascular function in AD.
METHODS


Thirty-nine patients with AD (79 ± 8 years) were recruited and randomly assigned to exercise training (EX, n = 20) or control group (CTRL, n = 19). All subjects performed 72 treatment sessions (90 min, 3 t/w). EX included moderate-high-intensity aerobic and strength training. CTRL included cognitive stimuli (visual, verbal, auditive). Before and after the 6-month treatment, the vascular function was measured by passive-leg movement test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, %). A blood sample was analyzed for vascular endothelial growth factor (VEGF). Arterial blood flow (BF) and shear rate (SR) were measured during EX and CTRL during a typical treatment session.
RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ 99.056 ml/min, p = 0.004), AUC (+ 37.359AU, p = 0.037) and VEGF (+ 8.825 pg/ml, p = 0.004). In the CTRL group, no difference between pre- and post-treatment was found for any variable. Increase in BF and SR was demonstrated during EX (BF + 123%, p < 0.05; SR + 134%, p < 0.05), but not during CTRL treatment.
CONCLUSION


Exercise training improves peripheral vascular function in AD. These ameliorations may be due to the repetitive increase in SR during exercise which triggers NO and VEGF upregulation. This approach might be included in standard AD clinical practice as an effective strategy to treat vascular dysfunction in this population.",2020,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[""patients with Alzheimer's disease"", ""patients with Alzheimer's disease (AD"", 'Thirty-nine patients with AD (79\u2009±\u20098\xa0years']","['exercise training (EX, n\u2009=\u200920) or control group (CTRL', 'Exercise training']","['Arterial blood flow (BF) and shear rate (SR', 'CTRL included cognitive stimuli (visual, verbal, auditive', 'vascular endothelial growth factor (VEGF', 'passive-leg movement\xa0test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, ', 'FMD', 'PLM ∆peak ', 'moderate-high-intensity aerobic and strength training', 'peripheral vascular function', 'vascular function', 'BF and SR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",39.0,0.064598,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy. massimo.venturelli@univr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Baldassarre', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Giuriato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ghinassi', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04447-w']
1487,32737183,Effects of Inactivation of the Periaqueductal Gray on Song Production in Testosterone-Treated Male Canaries ( Serinus canaria ).,"Male canaries ( Serinus canaria ) display seasonal changes in the motivation to sing which have been found to be dependent on the action of testosterone (T). During the breeding season when T is high, males sing at a higher rate compared with males with low T. The effect of T on song rate is known to be mediated by the medial preoptic nucleus (POM); however, it is unclear how T signaling in POM impacts song production. One potential mechanism is via modulation of dopaminergic input into song control nuclei by the periaqueductal gray (PAG). In order to test the role of PAG in T-mediated song production, we treated male canaries with peripheral T implants and implanted a guide cannula targeting the PAG. Through this guide cannula, we transiently inactivated PAG with injections of the GABA A  agonist, muscimol. Each bird received multiple infusions of both muscimol and saline with a 48-h washout period between treatments. The order of injection type was randomized and counterbalanced between individuals. Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection. These results support the hypothesis that PAG is involved in the production of song, potentially mediating the motivation to sing or alternatively interfering with the pre-motor activity of nucleus RA. Other song features were however not affected.",2020,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.",['Testosterone-Treated Male Canaries ( Serinus canaria '],['muscimol and saline'],[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C1095844', 'cui_str': 'Serinus canaria'}]","[{'cui': 'C0026818', 'cui_str': 'Muscimol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.0304729,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.","[{'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Haakenson', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742, chaakens@umd.edu.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balthazart', 'Affiliation': 'Laboratory of Behavioral Neuroendocrinology, GIGA Neurosciences, University of Liege, 15 Avenue Hippocrate, 4000, Liege, Belgium.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Ball', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742.'}]",eNeuro,['10.1523/ENEURO.0048-20.2020']
1488,32738349,"Clinical periodontal, bacterial, and immunological outcomes of antimicrobial photodynamic therapy in orthodontic treatment-induced gingival enlargement.","AIM


The aim of the present clinical trial is to evaluate the clinical, bacterial, and immunological outcomes of photodynamic therapy (PDT) in adolescent patients with orthodontic treatment-induced gingival enlargement (OTGE).
MATERIALS AND METHODS


A total of 26 adolescent patients, 16 girls and 10 boys, of mean age 16.8 years, undergoing fixed orthodontic treatment for at least 6 months (mean duration in months, 8.3 ± 1.9) and presenting with GE were included in the clinical trial. All patients undergoing fixed orthodontic treatment with clinical diagnosis of OTGE were divided into two groups: Patients receiving full-mouth periodontal debridement (FMPD) 'Group-FMPD' and 'Group-PDT' included participants receiving methylene blue-assisted PDT in the selected area along with FMPD. Clinical periodontal assessments included the evaluation of plaque scores (PS), bleeding on probing (BOP), probing depth (PD) and hyperplastic index (HI). The total bacterial counts of Porphyromonas gingivalis (P. gingivalis), Treponema denticola (T. denticola), and Tannerella forsythia (T. forsythia) were estimated and expressed as log CFU/mL of each bacteria. Cytokines including interleukin (IL)-1β and IL-6 were analyzed using enzyme-linked immunosorbent assay (ELISA) kit.
RESULTS


The mean percentage of PS and BOP statistically significantly reduced with both FMPD and PDT from baseline to 4 weeks (p < 0.05). Although mean PD significantly reduced in both the groups at all time points, there was significantly higher reduction with PDT as compared to FMPD at 2 weeks post treatment (p < 0.05). Inter-group comparison showed PDT demonstrated significantly higher HI at 2- and 4-weeks post treatment (p < 0.05). The mean log CFU/mL of P. gingivalis and T. forsythia showed statistically significantly higher reduction with PDT than FMPD (p < 0.05) at both 2-and 4-weeks follow-up. T. denticola reported significantly reduced levels at 2 weeks follow-up period only with PDT (p < 0.05). No statistically significant difference appeared when both treatment modalities were compared with one another (p > 0.05). Four weeks after periodontal treatment, IL-6 significantly reduced with PDT compared to FMPD (p < 0.05).
CONCLUSION


PDT assisted in reducing bacterial counts and improving hyperplastic index in OTGE.",2020,The mean log CFU/mL of P. gingivalis and T. forsythia showed statistically significantly higher reduction with PDT than FMPD (p < 0.05) at both 2-and 4-weeks follow-up.,"['All patients undergoing fixed orthodontic treatment with clinical diagnosis of OTGE', '26 adolescent patients, 16 girls and 10 boys, of mean age 16.8 years, undergoing fixed orthodontic treatment for at least 6 months (mean duration in months, 8.3\u2009±\u20091.9) and presenting with GE were included in the clinical trial', 'orthodontic treatment-induced gingival enlargement', 'adolescent patients with orthodontic treatment-induced gingival enlargement (OTGE']","['antimicrobial photodynamic therapy', 'photodynamic therapy (PDT', ""Patients receiving full-mouth periodontal debridement (FMPD) 'Group-FMPD' and 'Group-PDT' included participants receiving methylene blue-assisted PDT""]","['mean percentage of PS and BOP', 'total bacterial counts of Porphyromonas gingivalis (P. gingivalis), Treponema denticola (T. denticola), and Tannerella forsythia (T. forsythia', 'plaque scores (PS), bleeding on probing (BOP), probing depth (PD) and hyperplastic index (HI', 'Cytokines including interleukin (IL)-1β and IL-6', 'mean PD', 'bacterial counts and improving hyperplastic index', 'mean log CFU/mL of P. gingivalis and T. forsythia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017566', 'cui_str': 'Hyperplasia of gingiva'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439361', 'cui_str': 'cfu/mL'}]",26.0,0.0301008,The mean log CFU/mL of P. gingivalis and T. forsythia showed statistically significantly higher reduction with PDT than FMPD (p < 0.05) at both 2-and 4-weeks follow-up.,"[{'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Rafi A', 'Initials': 'RA', 'LastName': 'Togoo', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Muhammad Abdullah', 'Initials': 'MA', 'LastName': 'Kamran', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia. Electronic address: mmuhammad@kku.edu.sa.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101934']
1489,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1490,32747522,Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.,"OBJECTIVE


To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).
METHODS


HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.
RESULTS


The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale ( p  < 0.05) and PGIC scores ( p  < 0.0001) as well as significant reductions from baseline in WPAI:GH scores ( p  < 0.01) and presenteeism (impairment while working;  p  < 0.05) vs placebo.
CONCLUSIONS


Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.
CLINICALTRIALSGOV IDENTIFIER


NCT02621931.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.",2020,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","['patients with chronic migraine (CM', 'Patients With Chronic Migraine', '1121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with', 'patients with CM']","['fremanezumab', 'fremanezumab quarterly (675 mg at baseline, placebo', 'Fremanezumab', 'fremanezumab quarterly or monthly vs placebo', 'placebo']","[""health-related quality of life, health status, patients' global impression of change, and productivity"", 'Quality of Life and Productivity', 'health-related quality of life and productivity', 'migraine-specific quality of life, overall health status', 'EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire', 'Migraine-Specific Quality of Life (MSQoL) questionnaire', 'PGIC scores', 'WPAI:GH scores', 'Patient Global Impression of Change (PGIC) questionnaire', 'EQ-5D-5L visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1121.0,0.33054,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}]",Neurology,['10.1212/WNL.0000000000010000']
1491,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
1492,32737760,A Comparison of Analgesia After a Thoracoscopic Lung Cancer Operation with a Sustained Epidural Block and a Sustained Paravertebral Block: A Randomized Controlled Study.,"INTRODUCTION


This study aimed to compare the challenge of puncture and catheterization and the effect of postoperative analgesia of ultrasound-guided continuous thoracic paravertebral block and the continuous epidural analgesia in patients receiving thoracoscopic surgery for lung cancer.
METHODS


One-hundred and fifty patients received elective unilateral thoracoscopic surgery for lung cancer and were randomized into three groups; test group 1 (T group), test group 2 (P group), and the control group (E group). Both of the test groups received ultrasound-guided continuous thoracic paravertebral block (TPVB) while the control group received continuous epidural analgesia. After the operation, all the patients in the test groups received the same postoperative analgesia; loading dose 0.5 mg kg -1 , background dose 0.25 mg kg -1  h -1 , patient controlled analgesia (PCA) 0.25 mg kg -1 , and a locking time of 60 min, while the patients in the control group received a loading dose of 5 ml, a background dose of 5 ml h -1 , and a locking time of 20 min. The outcomes of this study were the success rate of the puncture and catheter placement, the blocked segments, numerical rating scale (NRS) scores at rest and during coughing, and the segments with reduced or lost cold and pinpricking sensation.
RESULTS


The success rates of the puncture and catheterization in group T were the highest. Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05). The puncture time in group T was the shortest; there was no difference between group E and group T. The time of catheterization in group P was the longest, this was followed by group T, and was the fastest in group E. The stable time of the block level in group E was shorter than that in groups P and T, but was similar between groups P and T. The block level of all three groups in the 4 h postoperative period was similar (p > 0.05), while the 4 h postoperative levels of groups P and T were reduced significantly (p < 0.05).
CONCLUSION


The continuous analgesia technique of paravertebral space catheterization cannot replace the continuous epidural analgesia in thoracoscopic lung cancer surgery as the latter technique is still considered to be the gold standard.
TRIAL REGISTRATION


China Clinical Trial Registration Center identifier ChiCTR1900020973.",2020,"Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05).","['One-hundred and fifty patients received', 'for lung cancer', 'patients receiving thoracoscopic surgery for lung cancer', 'thoracoscopic lung cancer surgery']","['postoperative analgesia of ultrasound-guided continuous thoracic paravertebral block', 'Thoracoscopic Lung Cancer Operation with a Sustained Epidural Block', 'loading dose of 5\xa0ml, a background dose of 5', 'elective unilateral thoracoscopic surgery', 'paravertebral space catheterization', 'puncture and catheterization', 'ultrasound-guided continuous thoracic paravertebral block (TPVB) while the control group received continuous epidural analgesia']","['failure rate of the puncture', 'puncture time', 'success rates of the puncture and catheterization', 'stable time of the block level', 'block level', 'time of catheterization', 'success rate of the puncture and catheter placement, the blocked segments, numerical rating scale (NRS) scores at rest and during coughing, and the segments with reduced or lost cold and pinpricking sensation', 'success rate of catheterization']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",150.0,0.0451201,"Compared with group P, the failure rate of the puncture in group E was lower (p < 0.05), but the success rate of catheterization was higher (p < 0.05).","[{'ForeName': 'Qiao-Wen', 'Initials': 'QW', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, 363000, China. luzhiwei9366@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01446-3']
1493,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1494,32747417,Prognostic and Predictive Biomarkers in Patients with Metastatic Colorectal Cancer Receiving Regorafenib.,"Regorafenib is a tyrosine kinase inhibitor approved by the FDA for the treatment of patients with chemotherapy refractory metastatic colorectal cancer (mCRC). Regorafenib inhibits signaling through multiple receptors associated with angiogenesis, metastasis, and tumor immunity. Here, we report biomarker results from LCCC1029, a randomized, placebo-controlled, phase II trial of chemotherapy ± regorafenib in patients with second-line mCRC. A panel of 20 soluble protein biomarkers (termed the Angiome) was assessed in the plasma of 149 patients from the LCCC1029 trial both at baseline and along the treatment continuum. Baseline protein levels were analyzed for prognostic and predictive value for progression-free survival (PFS) and overall survival (OS). Changes in protein levels during treatment were analyzed for potential pharmacodynamic effects. Six markers (HGF, IL6, PlGF, VEGF-R1, OPN, and IL6R) were found to be prognostic for PFS. Nine markers (IL6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS. Higher baseline levels of OPN ( P   intx  = 0.0167), VCAM-1 ( P   intx  = 0.0216), and PDGF-AA ( P   intx  = 0.0435) appeared to predict for PFS benefit from regorafenib compared with placebo. VCAM-1 was also potentially predictive of OS benefit from regorafenib compared with placebo ( P   intx  = 0.0124). On-treatment changes of six markers reflected potential on-target effect of regorafenib. Consistent results were observed in an Italian cohort where 105 patients with late-stage mCRC received regorafenib monotherapy. The key findings of this study suggest that VCAM-1 may be a predictive biomarker for regorafenib benefit, while multiple protein markers may be prognostic of outcome in patients with mCRC.",2020,"Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS.","['Metastatic Colorectal Cancer Patients Receiving Regorafenib', 'second-line mCRC patients', '149 patients from the LCCC1029 trial both at baseline and along the treatment continuum', 'chemotherapy-refractory metastatic colorectal cancer (mCRC) patients']","['regorafenib', 'chemotherapy ± regorafenib', 'Regorafenib', 'regorafenib monotherapy', 'placebo']","['progression-free survival (PFS) and overall survival (OS', 'Six markers (HGF, IL-6, PlGF, VEGF-R1, OPN, and IL-6R', 'OPN', 'Baseline protein levels', 'Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1', 'VCAM-1 ', 'protein levels']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0530678', 'cui_str': 'thrombospondin 2'}]",149.0,0.156656,"Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS.","[{'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bell Burdett', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Ace J', 'Initials': 'AJ', 'LastName': 'Hatch', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Starr', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Brady', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Hammond', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Dominic T', 'Initials': 'DT', 'LastName': 'Moore', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Hanna K', 'Initials': 'HK', 'LastName': 'Sanoff', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina. anixon@duke.edu.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-20-0249']
1495,32747473,Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness.,"BACKGROUND


One-third of outpatient antibiotic prescriptions for pediatric acute respiratory tract infections (ARTIs) are inappropriate. We evaluated a distance learning program's effectiveness for reducing outpatient antibiotic prescribing for ARTI visits.
METHODS


In this stepped-wedge clinical trial run from November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges. Visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection for children 6 months to <11 years old without recent antibiotic use were included. Clinicians received the intervention as 3 program modules containing online tutorials and webinars on evidence-based communication strategies and antibioti c prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months. The primary outcome was overall antibiotic prescribing rates for all ARTI visits. Mixed-effects logistic regression compared prescribing rates during each program module and a postintervention period to a baseline control period. Odds ratios were converted to adjusted rate ratios (aRRs) for interpretability.
RESULTS


Among 72 723 ARTI visits by 29 762 patients, intention-to-treat analyses revealed a 7% decrease in the probability of antibiotic prescribing for ARTI overall between the baseline and postintervention periods (aRR 0.93; 95% confidence interval [CI], 0.90-0.96). Second-line antibiotic prescribing decreased for streptococcal pharyngitis (aRR 0.66; 95% CI, 0.50-0.87) and sinusitis (aRR 0.59; 95% CI, 0.44-0.77) but not for acute otitis media (aRR 0.93; 95% CI, 0.83-1.03). Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
CONCLUSIONS


This program reduced antibiotic prescribing during outpatient ARTI visits; broader dissemination may be beneficial.",2020,"Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
","['children 6 months to <11 years old without recent antibiotic use were included', 'Primary Care for Respiratory Illness', 'November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges']",[],"['acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection', 'acute otitis media', 'sinusitis', 'streptococcal pharyngitis', 'viral ARTIs', 'probability of antibiotic prescribing for ARTI overall', 'overall antibiotic prescribing rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}]",[],"[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0001344', 'cui_str': 'Acute pharyngitis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036689', 'cui_str': 'Streptococcal sore throat'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",19.0,0.190718,"Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Kronman', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington; matthew.kronman@seattlechildrens.org.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gerber', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Communication, College of Liberal Arts and Sciences, Portland State University, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heritage', 'Affiliation': 'Department of Sociology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stout', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Burges', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hedrick', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Warren', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Shalowitz', 'Affiliation': 'NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steffes', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mangione-Smith', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}]",Pediatrics,['10.1542/peds.2020-0038']
1496,32745891,Automatic Imitation in Comorbid PTSD & Alcohol Use Disorder and Controls: an RCT of Intranasal Oxytocin.,"INTRODUCTION


Mimicking movements of others makes both the imitating and imitated partners feel closer. Oxytocin may increase focus on others and has been shown to increase automatic imitation in healthy controls (HC). However, this has not been replicated, and oxytocin's effects on automatic imitation have not been demonstrated in clinical populations. This study attempts to replicate effects on HC and examine effects on people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD).
METHODS


Fifty-four males with PTSD-AUD and 43 male HC received three intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU) in a randomized order, across three separate testing days, as part of a double-blind, crossover parent study. At 135 min post-administration, each performed the imitation-inhibition task, which quantifies automatic imitation as the congruency effect (CE). After exclusions, the final analyzed data set included 49 participants with PTSD-AUD and 38 HC.
RESULTS


In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase. In PTSD-AUD, oxytocin did not significantly increase CE. Post-hoc analysis showed the PTSD-AUD group had higher CE than HC on placebo visits.
DISCUSSION


Our data suggest PTSD-AUD is associated with higher automatic imitation than HC in the absence of oxytocin administration. We successfully replicated findings that oxytocin increases automatic imitation in HC. This demonstrates an unconscious motor effect induced by oxytocin, likely relevant to more complex forms of imitative movements, which have the potential to improve social connection. We did not find a significant effect of oxytocin on automatic imitation in PTSD-AUD. Future research should examine imitation in both sexes, at peak oxytocin levels, and on increasingly complex forms of imitation.",2020,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","['49 participants with PTSD-AUD and 38 HC', 'Fifty-four males with PTSD-AUD and 43 male HC', 'people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD', 'healthy controls (HC']","['intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU', 'oxytocin', 'Intranasal Oxytocin', 'Oxytocin']","['CE', 'automatic imitation']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]",49.0,0.0522705,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","[{'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: morrisont@gmail.com.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: lize.decoster@gmail.com.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Christopher.Stauffer@ucsf.edu.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: jin.wen2100@gmail.com.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: elnaz.ahmadi@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: Kevin.Delucchi@ucsf.edu.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Aoife.ODonovan@ucsf.edu.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Josh.Woolley@ucsf.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104787']
1497,32749941,Molecular Classification of the PORTEC-3 Trial for High-Risk Endometrial Cancer: Impact on Prognosis and Benefit From Adjuvant Therapy.,"PURPOSE


The randomized Adjuvant Chemoradiotherapy Versus Radiotherapy Alone in Women With High-Risk Endometrial Cancer (PORTEC-3) trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy (CTRT) versus radiotherapy alone (RT) for women with high-risk endometrial cancer (EC). Because The Cancer Genome Atlas defined an EC molecular classification with strong prognostic value, we investigated prognosis and impact of chemotherapy for each molecular subgroup using tissue samples from PORTEC-3 trial participants.
METHODS


Paraffin-embedded tissues of 423 consenting patients were collected. Immunohistochemistry for p53 and mismatch repair (MMR) proteins, and DNA sequencing for  POLE  exonuclease domain were done to classify tumors as p53 abnormal (p53abn),  POLE- ultramutated ( POLE mut), MMR-deficient (MMRd), or no specific molecular profile (NSMP). The primary end point was recurrence-free survival (RFS). Kaplan-Meier method, log-rank test, and Cox model were used for analysis.
RESULTS


Molecular analysis was successful in 410 high-risk EC (97%), identifying the 4 subgroups: p53abn EC (n = 93; 23%),  POLE mut (n = 51; 12%), MMRd (n = 137; 33%), and NSMP (n = 129; 32%). Five-year RFS was 48% for patients with p53abn EC, 98% for  POLE mut EC, 72% for MMRd EC, and 74% for NSMP EC ( P  < .001). The 5-year RFS with CTRT versus RT for p53abn EC was 59% versus 36% ( P  = .019); 100% versus 97% for patients with  POLE mut EC ( P  = .637); 68% versus 76% ( P  = .428) for MMRd EC; and 80% versus 68% ( P  = .243) for NSMP EC.
CONCLUSION


Molecular classification has strong prognostic value in high-risk EC, with significantly improved RFS with adjuvant CTRT for p53abn tumors, regardless of histologic type. Patients with  POLE mut EC had an excellent RFS in both trial arms. EC molecular classification should be incorporated in the risk stratification of these patients as well as in future trials to target specific subgroups of patients.",2020,The 5-year RFS with CTRT versus RT for p53abn EC was 59% versus 36% (,"['High-Risk Endometrial Cancer', 'Paraffin-embedded tissues of 423 consenting patients were collected', 'Women With High-Risk Endometrial Cancer', 'women with high-risk endometrial cancer (EC']","['Chemoradiotherapy Versus Radiotherapy', 'combined adjuvant chemotherapy and radiotherapy (CTRT) versus radiotherapy alone (RT', 'POLE', 'MMRd']","['excellent RFS', 'recurrence-free survival (RFS', '5-year RFS']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0337815', 'cui_str': 'Poles'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]",423.0,0.203555,The 5-year RFS with CTRT versus RT for p53abn EC was 59% versus 36% (,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'León-Castillo', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Department of Clinical Oncology, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Mileshkin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Mackay', 'Affiliation': 'Division of Medical Oncology and Hematology, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Naveena', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Pathology, Barts Health National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Pollock', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Canadian Cancer Trials Group, Department of Obstetrics and Gynecology, University of Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Canadian Cancer Trials Group, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Department of Radiotherapy, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Edmondson', 'Affiliation': ""Division of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biostatistics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': ""Division of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Crosbie', 'Affiliation': ""Division of Cancer Sciences, University of Manchester, St Mary's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'de Bruyn', 'Affiliation': 'Department of Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Horeweg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Tjalling', 'Initials': 'T', 'LastName': 'Bosse', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00549']
1498,32753300,Bariatric surgery in the elderly: a randomized prospective study comparing safety of sleeve gastrectomy and Roux-en-Y gastric bypass (BASE Trial).,"BACKGROUND


The aging population along with the obesity epidemic has increased the number of older patients undergoing bariatric surgery. Nevertheless, there is still conflicting data regarding surgical safety in this population.
OBJECTIVES


The aim of this study was to compare the surgical morbidity of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) for older patients.
SETTING


University hospital, São Paulo, Brazil.
METHODS


We performed a prospective randomized clinical trial from September 2017 to May 2019. Obese patients aged ≥65 years were randomized to LSG or LRYGB. Data collection included demographic information, body mass index (BMI), and co-morbidities. We assessed readmission, postoperative complications, and mortality. Complications were scored according to Clavien-Dindo classification.
RESULTS


A total of 36 patients, with a BMI between 35.5 and 52.8 kg/m 2  were randomized to either LSG (18 patients) or LRYGB (18 patients). The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13). Severe complication was more prevalent in LRYGB patients but had no statistically significant difference (0 versus 3, P = .07). Each group had 1 readmission and there was no mortality in 90-day follow-up.
CONCLUSIONS


Morbidity and mortality rates of bariatric surgery are low in elderly obese patients. Despite not statistically significant, LSG had a lower rate of severe complications compared with LRYGB in this population setting.",2020,"The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13).","['September 2017 to May 2019', 'older patients', 'elderly obese patients', 'Bariatric surgery in the elderly', '36 patients, with a BMI between 35.5 and 52.8 kg/m 2', 'older patients undergoing bariatric surgery', 'University hospital, São Paulo, Brazil', 'Obese patients aged ≥65 years']","['LSG or LRYGB', 'laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB', 'sleeve gastrectomy and Roux-en-Y gastric bypass', 'bariatric surgery', 'LSG']","['surgical morbidity', 'readmission, postoperative complications, and mortality', 'demographic information, body mass index (BMI), and co-morbidities', 'overall complication rate', 'Morbidity and mortality rates', 'severe complications', 'Severe complication']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",36.0,0.116361,"The overall complication rate was similar between LSG and LRYGB (3 versus 7, P = .13).","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pajecki', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Batista', 'Initials': 'ACB', 'LastName': 'Dantas', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil. Electronic address: carolbatista.med@gmail.com.'}, {'ForeName': 'Ana Lumi', 'Initials': 'AL', 'LastName': 'Kanaji', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Daniel Riccioppo Cerqueira Ferreira', 'Initials': 'DRCF', 'LastName': 'de Oliveira', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Marco Aurelio', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Bariatric and Metabolic Surgery Unit, Discipline of Digestive Surgery, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.05.030']
1499,32730905,Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.,"BACKGROUND


New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization.
STUDY DESIGN


This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months.
SUMMARY


This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.",2020,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","['200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI', 'patients with peripheral artery disease (PAD) undergoing arterial angioplasty', 'patients undergoing InfraPoPliteal angioplasty for critical limb ischemia', 'patients with CLI undergoing endovascular infrapopliteal revascularization', 'patients undergoing endovascular infrapopliteal revascularization']","['apixaban plus aspirin', 'apixaban 2.5 mg twice daily plus aspirin', 'Apixaban versus ClopidoGRel', 'standard of care dual antiplatelet therapy (DAPT', 'DAPT (clopidogrel plus aspirin', 'aspirin', 'clopidogrel', 'oral apixaban']","['composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death', 'thrombotic restenosis and artery re-occlusion', 'composite of major bleeding or clinically relevant non-major bleeding at 12 months', 'efficacy and safety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0397654', 'cui_str': 'Angioplasty of artery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3530461', 'cui_str': 'apixaban 2.5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.221901,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","[{'ForeName': 'Rodrigo Bruno', 'Initials': 'RB', 'LastName': 'Biagioni', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil. Electronic address: rbbiagioni@gmail.com.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Leandro Barile', 'Initials': 'LB', 'LastName': 'Agati', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacilotto', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil; Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Universidade Estadual Paulista (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Bruno Leonardo', 'Initials': 'BL', 'LastName': 'de Freitas Soares', 'Affiliation': 'Santa Casa de Maceio, Maceio, Alagoas, Brazil.'}, {'ForeName': 'Edwaldo Edner', 'Initials': 'EE', 'LastName': 'Joviliano', 'Affiliation': 'Hospital das Clínicas de Ribeirão Preto, São Paulo University Medical School (USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Walkiria Hueb', 'Initials': 'WH', 'LastName': 'Bernardi', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Valter Castelli', 'Initials': 'VC', 'LastName': 'Junior', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Roberto Augusto', 'Initials': 'RA', 'LastName': 'Caffaro', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Fioranelli', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Bonno', 'Initials': 'B', 'LastName': 'Van Bellen', 'Affiliation': 'Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivan Benaduce', 'Initials': 'IB', 'LastName': 'Casella', 'Affiliation': 'Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Ronald José Ribeiro', 'Initials': 'RJR', 'LastName': 'Fidelis', 'Affiliation': 'Vascular and Endovascular Surgery-Federal University of Bahia.'}, {'ForeName': 'Ronald Luiz Gomes', 'Initials': 'RLG', 'LastName': 'Flumignan', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony James', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA; Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}]",American heart journal,['10.1016/j.ahj.2020.06.010']
1500,32731812,Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children.,"OBJECTIVE


Early adversity is correlated with increased risk for negative outcomes, including psychopathology and atypical neurodevelopment. The authors aimed to test the causal impact of an early parenting intervention (Attachment and Biobehavioral Catch-Up; ABC) on children's neural processing of parent cues and on psychosocial functioning in a longitudinal randomized clinical trial.
METHODS


Participants (N=68, mean age, 10.0 years [SD=0.8 years]) were 46 high-risk children whose parents were randomly assigned to receive either the ABC intervention (N=22) or a control intervention (N=24) while the children were infants, in addition to a comparison sample of low-risk children (N=22). During functional MRI scanning, children viewed pictures of their own mothers and of a stranger.
RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition. Additionally, greater activity in these regions was associated with fewer total behavior problems. There was an indirect effect of early intervention on middle childhood psychosocial functioning mediated through increased activity in brain regions in response to maternal cues.
CONCLUSIONS


These results suggest that early parenting intervention (in this case the ABC intervention) can enhance brain regions supporting children's social cognitive development. In addition, the findings highlight these brain effects as a possible neural pathway through which ABC may prevent future behavior problems among high-risk children, yielding psychosocial benefits that endure through at least middle childhood without the need to intervene with the child directly.",2020,"RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition.","['Participants (N=68, mean age, 10.0 years [SD=0.8 years]) were 46 high-risk children whose parents', 'High-Risk Children']","['early parenting intervention', 'ABC intervention', 'control intervention', 'early parenting intervention (the Attachment and Biobehavioral Catch-Up; ABC']","[""children's neural processing of parent cues"", 'maternal cue-related activation', 'Brain Responses to Maternal Cues', 'total behavior problems']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.0293274,"RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition.","[{'ForeName': 'Emilio A', 'Initials': 'EA', 'LastName': 'Valadez', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Nim', 'Initials': 'N', 'LastName': 'Tottenham', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Tabachnick', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.20010011']
1501,32736893,Effect of clopidogrel vs. aspirin on pro-atherosclerotic NLRP1 inflammasome expression in endothelial cells. ECLOAS study.,"INTRODUCTION AND OBJECTIVES


NRP1 inflammasome is crucial in endothelial dysfunction. Platelets are mandatory for the inflammation that precedes it. Aspirin could inhibit NLRP1 inflammasome in endothelial cells, and clopidogrel could also provoke a reduction in vascular inflammation. A study was carried out on the influence of platelet inflammatory inhibition by P2Y receptor inhibition versus COX enzyme inhibition on the transcription of NLRP1 inflammasome in endothelial cells.
METHODS


An open-label, prospective, randomised crossover study with two periods of platelet inhibition enrolled 20 healthy volunteers. They received clopidogrel 75mg/day/7days and aspirin 100mg/day/7days. A venous blood sample was collected from all participants before and after this period. Human aortic endothelial cells (HAECs) were exposed for 2h in cultures. NLRP1 gene expression was then analysed in these cultures.
RESULTS


HAEC cultures that were exposed to baseline plasma showed higher expression of NLRP1 than HAECs exposed to plasma after one week of aspirin or clopidogrel intake [relative quantification (RQ), 1.077±0.05 vs. 1.002±0.06; OR, 1.8; 95% CI, 1.1-2.9; P<.01 and 1.077±0.05 vs. 1.04±0.03; OR, 1.7; 95% CI, 1.2-2.6; P<.001, respectively]. NLRP1 expression in HAEC cultures exposed to plasma after one week of aspirin or clopidogrel was similar to that observed in control HAECs that was no exposed to human plasma (PBS) [RQ; 1.002±0.06 vs. 1.009±0.03; OR, 0.9; 95% CI, 0.5-1.4; P=.7, and 1.04±0.03 vs. 1.009±0.03; OR, 0.8; 95% CI, 0.3-1.2; P=.5, respectively]. No difference was observed in NLRP1 percentage reduction in HAEC after aspirin or clopidogrel exposure (3.8% vs. 2.8%, P=.3, respectively).
CONCLUSIONS


Platelet inhibition by P2Y pathway is similar to COX pathway in NLRP1 expression inhibition in HAECs.",2020,"Aspirin could inhibit NLRP1 inflammasome in endothelial cells, and clopidogrel could also provoke a reduction in vascular inflammation.","['20 healthy volunteers', 'endothelial cells']","['aspirin or clopidogrel', 'clopidogrel vs. aspirin', 'clopidogrel 75mg/day/7days and aspirin 100mg/day/7days', 'Aspirin', 'P2Y receptor inhibition versus COX enzyme inhibition']","['NLRP1 percentage reduction in HAEC', 'Human aortic endothelial cells (HAECs', 'NLRP1 gene expression', 'NLRP1 expression', 'human plasma (PBS) [RQ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0390418', 'cui_str': 'purinoceptor P2Y6'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0877008', 'cui_str': 'Enzyme inhibition'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",20.0,0.0498052,"Aspirin could inhibit NLRP1 inflammasome in endothelial cells, and clopidogrel could also provoke a reduction in vascular inflammation.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bleda', 'Affiliation': 'Servicio de Angiología y Cirugía Vascular, Hospital Universitario de Getafe, Madrid, España. Electronic address: silbleik@yahoo.es.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'de Haro', 'Affiliation': 'Servicio de Angiología y Cirugía Vascular, Hospital Universitario de Getafe, Madrid, España.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Sánchez', 'Affiliation': 'Departamento de Investigación, Fundación para la investigación biomédica del Hospital Universitario de Getafe, Madrid, España.'}, {'ForeName': 'Ilsem', 'Initials': 'I', 'LastName': 'Laime', 'Affiliation': 'Servicio de Angiología y Cirugía Vascular, Hospital Universitario de Getafe, Madrid, España.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Acin', 'Affiliation': 'Servicio de Angiología y Cirugía Vascular, Hospital Universitario de Getafe, Madrid, España.'}]",Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis,['10.1016/j.arteri.2020.03.002']
1502,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
1503,32739537,Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.,"BACKGROUND


Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.
METHODS


The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.
CONCLUSIONS


The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).",2020,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"['acute coronary syndrome patients with multivessel disease', 'patients presenting with acute coronary syndrome and multivessel disease', 'patients with an acute coronary syndrome and multivessel disease', '1,525 patients 1:1 to', 'Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain']","['immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm', 'sirolimus-eluting biodegradable polymer-coated stents']","['composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1525.0,0.0551991,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"[{'ForeName': 'Wijnand K', 'Initials': 'WK', 'LastName': 'den Dekker', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands. Electronic address: w.dendekker@erasmusmc.nl.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': 'Cardiovascular institute, Hospital Clinic University of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rutger J', 'Initials': 'RJ', 'LastName': 'van Bommel', 'Affiliation': 'Department of Cardiology, Tergooi Blaricum, Blaricum, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Daemen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cummins', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Mattie J', 'Initials': 'MJ', 'LastName': 'Lenzen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.006']
1504,32747013,Phase II trial of bevacizumab and sorafenib in recurrent ovarian cancer patients with or without prior-bevacizumab treatment.,"OBJECTIVE


To examine whether blocking multiple points of the angiogenesis pathway by addition of sorafenib, a multi-kinase inhibitor against VEGFR2/3, Raf, c-Kit, and PDGFR, to bevacizumab would yield clinical activity in ovarian cancer (OvCa).
METHODS


This phase II study tested bevacizumab plus sorafenib in two cohorts; bevacizumab-naïve and bevacizumab-exposed patients. Bevacizumab (5 mg/kg IV every 2 weeks) was given with sorafenib 200 mg bid 5 days-on/2 days-off. The primary objective was response rate using a Simon two-stage optimal design. Progression-free survival (PFS) and toxicity were the secondary endpoints. Exploratory correlative studies included plasma cytokine concentrations, tissue proteomics and dynamic contrast-enhanced-magnetic resonance imaging (DCE-MRI).
RESULTS


Between March 2007 and August 2012, 54 women were enrolled, 41 bevacizumab-naive and 13 bevacizumab-prior, with median 5 (2-9) and 6 (5-9) prior systemic therapies, respectively. Nine of 35 (26%) evaluable bevacizumab-naive patients attained partial responses (PR), and 18 had stable disease (SD) ≥ 4 months. No responses were seen in the bevacizumab-prior group and 7 (54%) patients had SD ≥ 4 months, including one exceptional responder with SD of 27 months. The overall median PFS was 5.5 months (95%CI: 4.0-6.8 months). Treatment-related grade 3/4 adverse events (≥5%) included hypertension (17/54 [31%]; grade 3 in 16 patients and grade 4 in one patient) and venous thrombosis or pulmonary embolism (5/54 [9%]; grade 3 in 4 patients and grade 4 in one patient). Pretreatment low IL8 concentration was associated with PFS ≥ 4 months (p = .031).
CONCLUSIONS


The bevacizumab and sorafenib combination did not meet the pre-specified primary endpoint although some clinical activity was seen in heavily-pretreated bevacizumab-naive OvCa patients with platinum-resistant disease. Anticipated class toxicities required close monitoring and dose modifications.",2020,The overall median PFS was 5.5 months (95%CI: 4.0-6.8 months).,"['recurrent ovarian cancer patients with or without prior-bevacizumab treatment', '54 women were enrolled', 'naive patients attained partial responses (PR), and 18 had stable disease (SD)\xa0≥\xa04\xa0months', 'ovarian cancer (OvCa', 'exposed patients', 'Between March 2007 and August 2012']","['sorafenib', 'Bevacizumab', 'bevacizumab and sorafenib', 'sorafenib 200\xa0mg bid 5\xa0days-on/2\xa0days-off', 'bevacizumab', 'bevacizumab plus sorafenib', '41 bevacizumab-naive and 13 bevacizumab', 'bevacizumab-naïve and bevacizumab']","['Pretreatment low IL8 concentration', 'plasma cytokine concentrations, tissue proteomics and dynamic contrast-enhanced-magnetic resonance imaging (DCE-MRI', 'venous thrombosis or pulmonary embolism', 'overall median PFS', 'clinical activity', 'Progression-free survival (PFS) and toxicity', 'response rate', 'grade 3/4 adverse events', 'hypertension']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1677790', 'cui_str': 'sorafenib 200 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0872252', 'cui_str': 'Proteomics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",54.0,0.0516204,The overall median PFS was 5.5 months (95%CI: 4.0-6.8 months).,"[{'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America. Electronic address: leej6@mail.nih.gov.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Annunziata', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hays', 'Affiliation': 'Division of Medical Oncology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH, United States of America.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Genetics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Choyke', 'Affiliation': 'Molecular Imaging Program, Center for Cancer Research, National Cancer Institute, Bethesda, United States of America.'}, {'ForeName': 'Minshu', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'An', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America.""}, {'ForeName': 'Ismail Baris', 'Initials': 'IB', 'LastName': 'Turkbey', 'Affiliation': 'Molecular Imaging Program, Center for Cancer Research, National Cancer Institute, Bethesda, United States of America.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America.""}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, United States of America.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD, United States of America.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, United States of America.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.031']
1505,32421785,Prognostic Value of Masked Uncontrolled Hypertension Defined by Different Ambulatory Blood Pressure Criteria.,"BACKGROUND


Masked uncontrolled hypertension (MUCH), that is, nonhypertensive clinic but high out-of-office blood pressure (BP) in treated patients is at increased cardiovascular risk than controlled hypertension (CH), that is, nonhypertensive clinic and out-of-office BP. Using ambulatory BP, MUCH can be defined as daytime and/or nighttime and/or 24-hour BP above thresholds. It is unclear whether different definitions of MUCH have similar prognostic information. This study assessed the prognostic value of MUCH defined by different ambulatory BP criteria.
METHODS


Cardiovascular events were evaluated in 738 treated hypertensive patients with nonhypertensive clinic BP. Among them, participants were classified as having CH or daytime MUCH (BP ≥135/85 mm Hg) regardless of nighttime BP (group 1), nighttime MUCH (BP ≥120/70 mm Hg) regardless of daytime BP (group 2), 24-hour MUCH (BP ≥130/80 mm Hg) regardless of daytime or nighttime BP (group 3), daytime MUCH only (group 4), nighttime MUCH only (group 5), and daytime + nighttime MUCH (group 6).
RESULTS


We detected 215 (29%), 357 (48.5%), 275 (37%), 42 (5.5%),184 (25%) and 173 (23.5%) patients with MUCH from group 1 to 6, respectively. During the follow-up (10 ± 5 years), 148 events occurred in patients with CH and MUCH. After adjustment for covariates, compared with patients with CH, the adjusted hazard ratio (95% confidence interval) for cardiovascular events was 2.01 (1.45-2.79), 1.53 (1.09-2.15), 1.69 (1.22-2.34), 1.52 (0.80-2.91), 1.15 (0.74-1.80), and 2.29 (1.53-3.42) from group 1 to 6, respectively.
CONCLUSIONS


The prognostic impact of MUCH defined according to various ambulatory BP definitions may be different.",2020,"After adjustment for covariates, compared with patients with CH, the adjusted hazard ratio (95% confidence interval) for cardiovascular events was 2.01 (1.45-2.79), 1.53 (1.09-2.15), 1.69 (1.22-2.34), 1.52 (0.80-2.91), 1.15 (0.74-1.80), and 2.29 (1.53-3.42) from group 1 to 6, respectively.
",['738 treated hypertensive patients with nonhypertensive clinic BP'],[],"['cardiovascular events', 'nighttime MUCH (BP ≥120/70 mm Hg) regardless of daytime BP', '24-hour MUCH (BP ≥130/80 mm Hg) regardless of daytime or nighttime BP', 'daytime and/or nighttime and/or 24-hour BP above thresholds']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",[],"[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1282173', 'cui_str': '24 hour blood pressure'}, {'cui': 'C0443129', 'cui_str': 'Above threshold'}]",738.0,0.0362822,"After adjustment for covariates, compared with patients with CH, the adjusted hazard ratio (95% confidence interval) for cardiovascular events was 2.01 (1.45-2.79), 1.53 (1.09-2.15), 1.69 (1.22-2.34), 1.52 (0.80-2.91), 1.15 (0.74-1.80), and 2.29 (1.53-3.42) from group 1 to 6, respectively.
","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Coccina', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Pierdomenico', 'Affiliation': 'Department of Medicine and Aging Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cuccurullo', 'Affiliation': 'Department of Medicine and Aging Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Pizzicannella', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Rosalinda', 'Initials': 'R', 'LastName': 'Madonna', 'Affiliation': 'Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Trubiani', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cipollone', 'Affiliation': 'Department of Medicine and Aging Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}, {'ForeName': 'Sante D', 'Initials': 'SD', 'LastName': 'Pierdomenico', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""Gabriele d\'Annunzio"", Chieti-Pescara, Chieti, Italy.'}]",American journal of hypertension,['10.1093/ajh/hpaa078']
1506,32750063,Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.,"BACKGROUND


Maturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers.
METHOD


A subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified.
RESULTS


Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects.
CONCLUSION


Although these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.",2020,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","['mothers and children at 4-5 years of age', 'preterm infants and their mothers']","['RSA', 'Family nurture intervention', 'Family Nurture Intervention (FNI', 'NICU']","['Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency', 'autonomic regulation', 'levels of RSA', 'RSA']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0640867,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Porges', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Amie A', 'Initials': 'AA', 'LastName': 'Hane', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Katie Y', 'Initials': 'KY', 'LastName': 'Kwon', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Surman', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kolacz', 'Affiliation': 'Traumatic Stress Research Consortium, Kinsey Institute, Indiana University, Bloomington, IN, United States of America.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0236930']
1507,32739716,The comparison of access to an eHealth resource to current practice on mother and co-parent teamwork and breastfeeding rates: A randomized controlled trial.,"BACKGROUND


Breastfeeding rates are suboptimal, putting mothers and their infants' health at risk. One modifiable risk factor amenable to intervention is partner support. Having women work as a team with their co-parents to meet their breastfeeding goals has been found to improve breastfeeding outcomes. eHealth resources have been found to be accessible and feasible ways to provide breastfeeding education yet, the best way to design breastfeeding interventions for mothers and their co-parents is not known.
OBJECTIVES


To compare two study conditions to determine: (1) which way is more effective to provide breastfeeding education to women and their co-parents on increasing breastfeeding rates and associated secondary outcomes, such as breastfeeding knowledge, attitude, self-efficacy and overcoming challenges; (2) the difference in co-parenting and partner support between the study groups; (3) how parents in both groups preferred to access breastfeeding information; and (4) the groups' satisfaction with the eHealth resource that was provided.
DESIGN


This study used a randomized controlled trial design (Clinicaltrials.org #NCT03492411). Participants were randomly allocated to study groups with concealed opaque envelopes by a blinded research assistant. Participants in Study Condition #1 (SC1) accessed a previously created, online e-Health resource, in addition to other generally available resources they could access in the community; participants in Study Condition #2 (SC2) accessed only the generally available resources.
SETTING


Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada.
PARTICIPANTS


Expectant women (n = 113) and their co-parents (n = 104) were enrolled.
METHODS


After eligibility was determined, consents obtained and baseline surveys completed, group allocation was conducted. SC1 had a virtual meeting with a research assistant to review the eHealth resource. Weekly emails were sent to all participants for 6 weeks as reminders. Follow-up data were electronically collected from mothers and co-parents at 2 weeks post enrollment and 4, 12, 26 and 52-weeks postpartum.
RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different. High scores were found in both groups in secondary outcome measures. Generally available breastfeeding resources were used in both groups with websites being used often and rated as most helpful. SC1 rated the eHealth resource provided to them highly.
CONCLUSION


The findings suggest both mothers and their co-parents should be targeted in breastfeeding education and web-based resources designed to meet their needs.",2020,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","['Expectant women (n\xa0=\xa0113) and their co-parents (n\xa0=\xa0104) were enrolled', 'Participants in Study Condition', ""Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada""]",[],['Breastfeeding rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",104.0,0.0703829,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Abbass-Dick', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada. Electronic address: jennifer.abbassdick@ontariotechu.ca.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Newport', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Fangli', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Godfrey', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Goodman', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University.'}]",Midwifery,['10.1016/j.midw.2020.102812']
1508,32741773,Ubiquinol supplementation in elderly patients undergoing aortic valve replacement: biochemical and clinical aspects.,"Epidemiological data show a rise in the mean age of patients affected by heart disease undergoing cardiac surgery. Senescent myocardium reduces the tolerance to ischemic stress and there are indications about age-associated deficit in post-operative cardiac performance. Coenzyme Q10 (CoQ10), and more specifically its reduced form ubiquinol (QH), improve several conditions related to bioenergetic deficit or increased exposure to oxidative stress. This trial (Eudra-CT 2009-015826-13) evaluated the clinical and biochemical effects of ubiquinol in 50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either placebo or 400 mg/day ubiquinol from 7 days before to 5 days after surgery. Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin I, CK-MB (primary endpoints), IL-6 and S100B were assessed. Moreover, main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints) were evaluated during a 6-month follow-up visit. Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin I (QH, 1.90 [1.47-2.48] ng/dL; placebo, 4.03 [2.45-6.63] ng/dL; p=0.007) related to cardiac surgery. Moreover, ubiquinol prevented the adverse outcomes that might have been associated with defective left ventricular ejection fraction recovery in elderly patients.",2020,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"['50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either', 'elderly patients undergoing aortic valve replacement', 'mean age of patients affected by heart disease undergoing cardiac surgery', 'elderly patients']","['Coenzyme Q10 (CoQ10', 'Ubiquinol supplementation', 'placebo or 400 mg/day ubiquinol', 'dL; placebo']","['Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin', 'troponin', 'main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints', 'post-operative plasma CoQ10 decline (p<0.0001) and oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",50.0,0.241265,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Orlando', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Sabbatinelli', 'Affiliation': 'Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona 60100, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Silvestri', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Marcheggiani', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Cirilli', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Phiwayinkosi Vusi', 'Initials': 'PV', 'LastName': 'Dludla', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Molardi', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nicolini', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tiano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}]",Aging,['10.18632/aging.103742']
1509,32746928,The effects of nudging and pricing on healthy food purchasing behavior in a virtual supermarket setting: a randomized experiment.,"BACKGROUND


Evidence on what strategies - or combination of strategies - are most effective and equitable in promoting healthier diets is needed. This study examined the efficacy of nudging and pricing strategies on increasing healthy food purchases and the potential differential effect by socio-economic position (SEP) among Dutch adults in a virtual supermarket.
METHODS


A randomized study design was conducted within a virtual supermarket (SN VirtuMart). Participants were exposed to five within-subject study conditions (control, nudging, pricing, price salience and price salience with nudging) and randomized to one of three between-subject study arms (a 25% price increase on unhealthy products, a 25% discount on healthy products, or a 25% price increase and discount). In total, 455 participants of low and high SEP (using either education or income as proxy) were randomized to conduct their weekly shopping in a virtual supermarket for five consecutive weeks. The primary outcome included the percentage of healthy purchases. Data were analyzed using linear mixed models.
RESULTS


In total, 346 (76%) adults completed all five shops within the SN VirtuMart. Median age was 32.5, 49.2% had high education and 32.8% had high income. Out of the 12 conditions, four conditions were statistically significantly different from the control condition. Nudging and non-salient pricing strategies alone did not statistically significantly increase healthy food purchases, whereas a combination of salient price increases and discounts led to an increase in the percentage of healthy food purchases (B 4.5, 95%CI 2.6; 6.4). Combining salient pricing and nudging strategies led to increases in the percentage of healthy products in all three pricing arms, with largest effects found in the combined price increase and discount arm (B = 4.0, 95%CI = 2.0; 6.0). Effects were not modified by SEP.
CONCLUSIONS


Combining health-related price increases and discounts and combining these salient pricing strategies with nudges in a supermarket setting seems to stimulate healthy food purchases for both low and high SEP populations. However, further research in real-world settings is needed.
TRIAL REGISTRATION


This randomized trial ( NTR7293 ) was registered in the Dutch trial registry ( www.trialregister.nl ).",2020,"Combining salient pricing and nudging strategies led to increases in the percentage of healthy products in all three pricing arms, with largest effects found in the combined price increase and discount arm (B = 4.0, 95%CI = 2.0; 6.0).","['Dutch adults in a virtual supermarket', 'In total, 346 (76%) adults completed all five shops within the SN VirtuMart', 'healthy food purchasing behavior in a virtual supermarket setting', 'Median age was 32.5, 49.2% had high education and 32.8% had high income', '455 participants of low and high SEP (using either education or income as proxy']","['price increase on unhealthy products, a 25% discount on healthy products, or a 25% price increase and discount', 'nudging and pricing', 'nudging and pricing strategies']","['percentage of healthy products', 'percentage of healthy purchases', 'percentage of healthy food purchases']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033118', 'cui_str': 'Pricing'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",455.0,0.088994,"Combining salient pricing and nudging strategies led to increases in the percentage of healthy products in all three pricing arms, with largest effects found in the combined price increase and discount arm (B = 4.0, 95%CI = 2.0; 6.0).","[{'ForeName': 'Jody C', 'Initials': 'JC', 'LastName': 'Hoenink', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Amsterdam Public Health research institute, De Boelelaan, 1117, Amsterdam, the Netherlands. j.c.hoenink@amsterdamumc.nl.'}, {'ForeName': 'Joreintje D', 'Initials': 'JD', 'LastName': 'Mackenbach', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Amsterdam Public Health research institute, De Boelelaan, 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Waterlander', 'Affiliation': 'Department of Public Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Amsterdam Public Health research institute, De Boelelaan, 1117, Amsterdam, the Netherlands.'}, {'ForeName': 'Nynke', 'Initials': 'N', 'LastName': 'van der Laan', 'Affiliation': 'Department of Communication and Cognition, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'Joline W J', 'Initials': 'JWJ', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Amsterdam Public Health research institute, De Boelelaan, 1117, Amsterdam, the Netherlands.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01005-7']
1510,32745703,"Randomized controlled trial of the COPE-P intervention to improve mental health, healthy lifestyle behaviors, birth and post-natal outcomes of minority pregnant women: Study protocol with implications.","BACKGROUND


Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them.
AIM


Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms.
METHODS


Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed.
CONCLUSION


If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.",2020,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","['minority pregnant women experiencing depressive, anxiety and stress symptoms', 'minority pregnant women', '384 women are being recruited from antenatal clinics if they are: between 18 and 40\u202fyears; in an uncomplicated singleton pregnancy <18\u202fweeks; and self-identify as Black or Hispanic', 'pregnant women']","['COPE-P intervention', 'COPE-P versus an attention control program']","['healthy lifestyle behaviors and mental health outcomes', 'mental health, healthy lifestyle behaviors, birth and post-natal outcomes']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",384.0,0.137281,"If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.","[{'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': 'Health Promotion and Wellness, The Ohio State University, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, College of Nursing, Pediatrics & Psychiatry, College of Medicine, The Ohio State University, 1585 Neil Ave, Columbus, OH 43210, United States of America. Electronic address: melnyk.15@osu.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gennaro', 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Szalacha', 'Affiliation': 'Research Methodology and Biostatistics Core, USF Health Morsani College of Medicine, College of Nursing, University of South Florida, United States of America.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': 'Consumer Core, the Helene Fuld Health Trust National Institute for Evidence-based Practice in Nursing and Healthcare, The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'William F. Connell School of Nursing, Boston College, Chestnut Hill, MA, United States of America.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gibeau', 'Affiliation': 'Midwifery, Jacobi Medical Center, Bronx, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106090']
1511,32750332,The effect of oxytocin on pupil response to naturalistic dynamic facial expressions.,"The neuropeptide oxytocin (OT) has been found to play an important role in a variety of social behaviours and social cognition in particular. The social salience hypothesis of OT suggests that OT shifts attention towards socially relevant stimuli, which offers an explanation for improvements on social cognition measures following OT administration. Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention. The current study aimed to investigate the effects of OT on pupillary responses to more naturalistic social stimuli in a larger sample. Ninety-four male participants took part in the double-blind, placebo controlled, mixed-design study, in which they self-administered either an OT or PL nasal spray before viewing naturalistic dynamic facial expressions of emotion (happy, sad, fear and anger). Contrary to prediction, there was no effect of OT administration on pupil diameter. The results are discussed in light of the social salience hypothesis and with reference to the methodological differences between studies.",2020,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.",['Ninety-four male participants took part in the double-blind'],"['OT', 'oxytocin', 'OT or PL nasal spray', 'neuropeptide oxytocin (OT', 'placebo']","['social cognition measures', 'pupil response to naturalistic dynamic facial expressions', 'emotion (happy, sad, fear and anger']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",94.0,0.0408089,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Burley', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Daughters', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, United Kingdom of Great Britain and Northern Ireland. Electronic address: k.daughters@essex.ac.uk.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104837']
1512,32751812,Does A Multiple-Sport Intervention Based on the TGfU Pedagogical Model for Physical Education Increase Physical Fitness in Primary School Children?,"Teaching Games for Understanding (TGfU) is one of the pedagogical models used for increasing health through physical education (PE), being associated with several psychological benefits. However, only few studies have studied the effect of TGfU on physical fitness. This study aims at assessing the changes in students' physical fitness after a six-month TGfU-based program with primary school children. A total of eight schools from the state of Sonora (Mexico) were randomly distributed into experimental (EG) and control group (CG). The final sample consisted of 188 pupils (100 boys, 88 girls; age = 10.22 ± 0.76 years) from the 5th and 6th grade. Employing a quasi-experimental design, physical fitness was assessed by means of the Eurofit test battery. At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048). Our findings suggest that TGfU can be a valid alternative to traditional methodologies not only when the aim of a PE unit is to stimulate the cognitive domain, but also for the development of physical fitness attributes that may help pupils develop in a comprehensive manner.",2020,"At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048).","['Primary School Children', ""students' physical fitness after a six-month TGfU-based program with primary school children"", 'A total of eight schools from the state of Sonora (Mexico', '188 pupils (100 boys, 88 girls; age = 10.22 ± 0.76 years) from the 5th and 6th grade']",[],"['low-limb power', 'cardiorespiratory fitness']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",[],"[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",188.0,0.0104797,"At post-test, EG obtained significantly higher scores than CG in flexibility, abdominals, speed ( p  < 0.001), handgrip ( p  = 0.002), low-limb power ( p  = 0.032), and cardiorespiratory fitness ( p  = 0.048).","[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Cocca', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Jovanny Edmundo', 'Initials': 'JE', 'LastName': 'Carbajal Baca', 'Affiliation': 'Degree in Sport Training, State University of Sonora, Boulevard Rosales 189, Colonia Centro, 83079 Hermosillo, Mexico.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Hernández Cruz', 'Affiliation': 'School of Sport Organization, Autonomous University of Nuevo Leon, Ciudad Universitaria s/n, 66455 San Nicolás de los Garza, Mexico.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Cocca', 'Affiliation': 'School of Sport Organization, Autonomous University of Nuevo Leon, Ciudad Universitaria s/n, 66455 San Nicolás de los Garza, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17155532']
1513,32741143,"Pulmonary Adverse Events in Patients Receiving Low-Dose Methotrexate in the Randomized, Double-Blind, Placebo-Controlled Cardiovascular Inflammation Reduction Trial.","OBJECTIVE


We previously reported that low-dose methotrexate (MTX) was associated with an increased risk of pulmonary adverse events (AEs) in a large randomized, placebo-controlled trial. Herein, we report details on the predictors and severity of pulmonary AEs.
METHODS


We conducted a prespecified analysis of pulmonary AEs in the Cardiovascular Inflammation Reduction Trial. Adults with known cardiovascular disease and diabetes/metabolic syndrome were randomly allocated to receive low-dose MTX (target dose 15-20 mg/week) or placebo after a 6-8-week open-label run-in phase in which all patients received low-dose MTX. Individuals with systemic inflammatory diseases were excluded. Pulmonary AEs were adjudicated in a blinded manner. We described severe pulmonary AEs and examined associations of baseline characteristics with pulmonary AEs in patients receiving low-dose MTX.
RESULTS


A total of 2,391 subjects were randomized to receive low-dose MTX and 2,395 to receive placebo. There were 13 severe pulmonary AEs (0.5%) and 7 cases of possible pneumonitis (0.3%) in the low-dose MTX group, compared to 8 (0.3%) and 1 (<0.1%), respectively, in the placebo group. Among those randomized to receive low-dose MTX, risk factors for any pulmonary AE included female sex (hazard ratio [HR] 1.69 versus male sex [95% confidence interval (95% CI) 1.16-2.45]), white race (HR 2.35 versus other race [95% CI 1.03-5.36]), and insulin use (HR 1.60 versus non-use [95% CI 1.11-2.30]). The only risk factor for severe pulmonary AEs was older age at baseline (HR 1.09 per year increase [95% CI 1.02-1.16]).
CONCLUSION


In this large placebo-controlled trial, pulmonary AEs, including possible pneumonitis, were uncommon but were more likely to occur in those randomized to receive low-dose MTX. White race, older age, male sex, and insulin use were associated with an increased risk of pulmonary AEs in those receiving low-dose MTX.",2020,"Risk factors for severe pulmonary AEs included only older baseline age (HR 1.09 per increasing year, 95%CI 1.02-1.16).
","['Adults with known cardiovascular disease and diabetes/metabolic syndrome', 'Individuals with systemic inflammatory diseases', '2,391 subjects']","['open-label run-in with LD-MTX', 'methotrexate (LD-MTX', 'methotrexate', 'LD-MTX', 'placebo']","['severe pulmonary AEs', 'possible pneumonitis', 'Pulmonary adverse events', 'risk of pulmonary AE of LD-MTX']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",2391.0,0.666728,"Risk factors for severe pulmonary AEs included only older baseline age (HR 1.09 per increasing year, 95%CI 1.02-1.16).
","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41452']
1514,32747351,"Protocol for economic evaluation alongside the SHINE (Supporting Healthy Image, Nutrition and Exercise) cluster randomised controlled trial.","INTRODUCTION


Limited evidence exists on the cost-effectiveness of interventions to prevent obesity and promote healthy body image in adolescents. The SHINE (Supporting Healthy Image, Nutrition and Exercise) study is a cluster randomised control trial (cRCT) aiming to deliver universal education about healthy nutrition and physical activity to adolescents, as well as targeted advice to young people with body image concerns who are at risk of developing disordered eating behaviours. This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
METHODS AND ANALYSIS


A public payer perspective will be adopted, with intervention costs collected prospectively. Within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will quantify the incremental costs and health gains of the intervention as compared with usual practice (ie, teacher-delivered curriculum). CEA will present results as cost per body mass index unit saved. CUA will present results as cost per quality-adjusted life year gained. A modelled CUA will extend the target population, time horizon and decision context to provide valuable information to policymakers on the potential for incremental cost offsets attributable to disease prevention arising from intervention. Intervention costs and effects will be extrapolated to the population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort's lifetime. Modelled CUA results will be presented as health-adjusted life years saved and healthcare cost-savings of diseases averted. Incremental cost-effectiveness ratios will be calculated as the difference in costs between the intervention and comparator divided by the difference in benefit. Semi-structured interviews with key intervention stakeholders will explore the potential impact of scalability on cost-effectiveness. These data will be thematically analysed to inform sensitivity analysis of the base case economic evaluation, such that cost-effectiveness evidence is reflective of the potential for scalability.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Deakin University Human Research Ethics Committee (#2017-269) and the Victorian Department of Education and Training (#2018_003630). Study findings will be disseminated through peer-reviewed academic papers and participating schools will receive annual reports over the 3 years of data collection.
TRIAL REGISTRATION NUMBER


ACTRN 12618000330246; Pre-results.",2020,"This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
","['young people with body image concerns who are at risk of developing disordered eating behaviours', ""population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort's lifetime"", 'adolescents']","['CUA', 'CEA', 'cost-utility analysis (CUA']",['Incremental cost-effectiveness ratios'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0974056,"This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Geelong, Victoria, Australia victoria.brown@deakin.edu.au.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Deakin University, Geelong, Institute for Health Transformation, School of Health and Social Development, Geelong, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McGivern', 'Affiliation': 'Deakin University, Geelong, Institute for Health Transformation, School of Health and Social Development, Geelong, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': ""Department of Paediatrics, The University of Melbourne; Centre for Adolescent Health Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Deakin University, Geelong, Faculty of Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Deakin University, Geelong, School of Information Technology, Geelong, Victoria, Australia.'}, {'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Hesketh', 'Affiliation': 'Deakin University, Geelong, Institute for Physical Activity and Nutrition, Faculty of Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'School of Medicine, Washington University in St. Louis, Missouri, Missouri, USA.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Geelong, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038050']
1515,32745732,Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization.,"BACKGROUND


Secondary preventive therapies play a key role in the prevention of adverse events after coronary artery bypass grafting (CABG). However, adherence to secondary preventive drugs after CABG is often poor. With the increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve medication adherence. We aimed to evaluate the effectiveness and feasibility of using a smartphone-based application to improve medication adherence in patients after CABG.
METHODS


The Measurement and Improvement Studies of Surgical coronary revascularizatION: medication adherence (MISSION-2) study is a multicenter randomized controlled trial that planned to enroll over 1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications. The investigators randomly assigned the participants to one of two groups: (1) the intervention group with an advanced smartphone application for 6 months which was designed specifically for this trial and did not exist before. Participants could receive medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care. The primary outcome was CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 6 months after randomization. The secondary outcomes were mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status. All analyses were conducted using the intention-to-treat principle.
RESULTS


A total of 1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016 and were randomly assigned to the intervention (n = 501) or control group (n = 499). At 6 months, the proportion of low-adherence participants, categorized by MMAS-8 scores, was 11.8% in the intervention group and 11.7% in the control group (RR = 1.005, 95% CI 0.682 to 1.480, P = 1.000). Similar results were found in sensitivity analyses that considered participants who withdrew from the study, or were lost to follow-up as nonadherent. There were no significant differences in the secondary clinical outcome measures, and there were no significant differences in the primary outcome across the subgroups tested. In the intervention group, the proportion of participants who used and operated the application during the first month after CABG was 88.1%; however, the use rate decreased sharply from 42.5% in the second month to 9.2% by the end of the study (6 months).
CONCLUSIONS


A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications. The limited room for improvement in medication adherence and the low participants' engagement with the smartphone applications might account for these non-significant outcomes.",2020,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"['patients after CABG', 'coronary artery bypass grafting (CABG', 'patients after surgical coronary revascularization', '1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications', '1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016']","['Surgical coronary revascularizatION', 'smartphone-based application', 'Smartphone-based application', 'medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care', 'intervention group with an advanced smartphone application']","['proportion of low-adherence participants, categorized by MMAS-8 scores', 'mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status', 'CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1000.0,0.0677726,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: raochenfeifuwai@126.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: zhengzhe@fuwai.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.019']
1516,32745733,"Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).","BACKGROUND


Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.
METHODS/DESIGN


The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.
DISCUSSION


The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.
TRIAL REGISTRATION


clinicaltrials.gov: NCT04160130.",2020,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","['440 patients across 35 sites in Europe', 'female than male patients', 'Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status', 'female patients with severe symptomatic aortic stenosis', 'women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk', 'female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA', 'women with severe symptomatic aortic stenosis']","['surgical aortic valve replacement (SAVR', 'transcatheter (TAVR', 'transcatheter heart valve replacement', 'TAVR with SAVR', 'TAVR']","['composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure', 'safety and efficacy', 'cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0182431', 'cui_str': 'Aortic valve prosthesis'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.159675,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Eltchaninoff', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bonaros', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Nietlispach', 'Affiliation': 'CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sykorova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurucova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.016']
1517,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1518,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1519,32761068,Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations.,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released. The guideline authors decided to proceed with publication but to update the decompressive craniectomy recommendations later in the spirit of ""living guidelines,"" whereby topics are updated more frequently, and between new editions, when important new evidence is published. The update to the decompressive craniectomy chapter presented here integrates the findings of the RESCUEicp study as well as the recently published 12-mo outcome data from the DECRA (Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury) trial. Incorporation of these publications into the body of evidence led to the generation of 3 new level-IIA recommendations; a fourth previously presented level-IIA recommendation remains valid and has been restated. To increase the utility of the recommendations, we added a new section entitled Incorporating the Evidence into Practice. This summary of expert opinion provides important context and addresses key issues for practitioners, which are intended to help the clinician utilize the available evidence and these recommendations. The full guideline can be found at: https://braintrauma.org/guidelines/guidelines-for-the-management-of-severe-tbi-4th-ed#/.",2020,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.",['Patients With Severe Traumatic Brain Injury) trial'],"['DECRA (Decompressive Craniectomy', 'decompressive craniectomy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}]",[],,0.0441026,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.","[{'ForeName': 'Gregory W J', 'Initials': 'GWJ', 'LastName': 'Hawryluk', 'Affiliation': 'Section of Neurosurgery, GB1-Health Sciences Centre, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Rubiano', 'Affiliation': 'INUB-MEDITECH Research Group, Universidad El Bosque, Bogota, Colombia.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Totten', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': ""O'Reilly"", 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ullman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Bratton', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Chesnut', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Odette A', 'Initials': 'OA', 'LastName': 'Harris', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kissoon', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Tasker', 'Affiliation': ""Harvard Medical School & Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Monica S', 'Initials': 'MS', 'LastName': 'Vavilala', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilberger', 'Affiliation': 'Drexel University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lumba-Brown', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Ghajar', 'Affiliation': 'Stanford University, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyaa278']
1520,32739045,Minimising haemodynamic lability during changeover of syringes infusing norepinephrine in adult critical care patients: a multicentre randomised controlled trial.,"BACKGROUND


Arterial pressure lability is common during the process of replacing syringes used for norepinephrine infusions in critically ill patients. It is unclear if there is an optimal approach to minimise arterial pressure instability during this procedures. We investigated whether 'double pumping' changeover (DPC) or automated changeover (AC) reduced blood pressure lability in critically ill adults compared with quick syringe changeover (QC).
METHODS


Patients requiring a norepinephrine infusion syringe change were randomised in a non-blinded trial undertaken in six ICUs. Randomisation was minimised by norepinephrine flow rate at inclusion and centre. The primary outcome was the frequency of increased/decreased mean arterial pressure (defined by </>15 mm Hg from baseline measurements) within 15 min of switching the syringe compared with QC.
RESULTS


Patients (mean age: 64 (range:18-88)) yr were randomly assigned to QC (n=95), DPC (n=95), or AC (n=96). Increased MAP was the commonest consequence of syringe changeovers. MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001). Fewer events occurred with QC compared with DPC (P=0.002). Sensitivity analysis based on mixed models showed that performing several changeovers on a single patient had no impact. Both type of changeover and norepinephrine dose before syringe changeover were independently associated with MAP variations >15 mm Hg.
CONCLUSIONS


Quick changeover of norepinephrine syringes was associated with less blood pressure lability compared with DPC. The prevalence of MAP variations was the same between AC and QC.
CLINICAL TRIAL REGISTRATION


NCT02304939.",2020,MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001).,"['critically ill adults', 'adult critical care patients', 'Patients requiring a', 'critically ill patients', 'Patients (mean age: 64 (range:18-88', 'n=95), DPC (n=95), or AC (n=96']","['norepinephrine infusion syringe', 'norepinephrine infusions', ""double pumping' changeover (DPC) or automated changeover (AC"", 'norepinephrine syringes', 'QC', 'norepinephrine', 'quick syringe changeover (QC']","['haemodynamic lability', 'frequency of increased/decreased mean arterial pressure', 'blood pressure lability', 'prevalence of MAP variations', 'MAP variability']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0520854', 'cui_str': 'Decreased mean arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.626804,MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001).,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Poiroux', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France; UMR CNRS 6015-INSERM UI083 MitoVasc Institute, University of Angers, Angers, France. Electronic address: lapoiroux@chu-angers.fr.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Le Roy', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Anne-Sylvie', 'Initials': 'AS', 'LastName': 'Ramelet', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland; Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mélaine', 'Initials': 'M', 'LastName': 'Le Brazic', 'Affiliation': 'Medical Intensive Care Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Messager', 'Affiliation': 'Department of Anesthesiology and Critical Care, Critical Care Unit, Angers University Hospital, Angers, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Gressent', 'Affiliation': 'Medical Intensive Care Unit, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Yolaine', 'Initials': 'Y', 'LastName': 'Alcourt', 'Affiliation': 'Intensive Care Department, Vendée Regional Hospital, La Roche-sur-Yon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Haubertin', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Critical Care Unit, University Teaching Hospital of Purpan, Toulouse, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Hamel', 'Affiliation': 'Department of Methodology and Biostatistics, Angers University Hospital, Angers, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Piquilloud', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France; Adult Intensive Care and Burn Unit, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland; UMR CNRS 6015-INSERM UI083 MitoVasc Institute, University of Angers, Angers, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mercat', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.041']
1521,32739072,The effectiveness of an oral hygiene program combined with health-promoting counseling for rural adults with cardiometabolic risks: A quasi-experimental design.,"AIM


The aim of this study was to explore the effectiveness of an oral hygiene program combined with home-phone health promoting counseling for rural adults with metabolic syndrome.
BACKGROUND


Metabolic syndrome is an important risk factor for cardiometabolic diseases. Evidence indicates that the poor oral hygiene and unhealthy lifestyles are closely related to metabolic syndrome.
METHODS


A prospective quasi-experimental design involved a total of 136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018. The primary outcome was the change in cardiometabolic biomarkers. The secondary outcome comprised changes in the health-promoting behaviors. The intervention effect was assessed using a generalized estimating equation model.
RESULTS


There were 80 and 56 participants in the intervention and control group, respectively. The mean age was 56 years and ranged from 33 to 70 years. The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
CONCLUSION


This study supports the use of an oral hygiene program combined with home-phone counseling, which offers more advantages than its counterpart. Considering the global epidemic of cardiometabolic diseases, this is a community health nursing model worth to replicate and evaluate. Further study should consider innovative strategies to improve the awareness and adoption of a healthy lifestyle in residents with cardiometabolic risks.",2020,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","['rural adults with metabolic syndrome', '136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018', 'The mean age was 56\u202fyears and ranged from 33 to 70\u202fyears', 'residents with cardiometabolic risks', 'rural adults with cardiometabolic risks']","['oral hygiene program combined with health-promoting counseling', 'oral hygiene program combined with home-phone counseling', 'oral hygiene program combined with home-phone health promoting counseling']","['waist circumference', 'use of dental floss', 'body fat percentage', 'body mass index', 'triglyceride level', 'regular tooth scaling', 'physical activity', 'total score of health-promoting behaviors', 'change in cardiometabolic biomarkers', 'health-promoting behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0204173', 'cui_str': 'Scaling of tooth'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",136.0,0.0293092,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","[{'ForeName': 'Jui-Chu', 'Initials': 'JC', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Ming-Shyan', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Wen-Nan', 'Initials': 'WN', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Yunlin, Taiwan.'}, {'ForeName': 'Tung-Jung', 'Initials': 'TJ', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Mei-Yen', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Chiayi, Taiwan; School of Nursing, Chang Gung University, Taoyuan, Taiwan; Department of Cardiology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: meiyen@mail.cgust.edu.tw.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151333']
1522,32739073,A quasi-experimental study of the effect of an intervention on older stroke survivors' functionality.,,2020,,"[""older stroke survivors' functionality""]",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],[],,0.0196864,,"[{'ForeName': 'Odete', 'Initials': 'O', 'LastName': 'Araújo', 'Affiliation': 'School of Nursing, University of Minho, Braga, Portugal; Health Sciences Research Unit, Nursing (UICISA E: UMinho), Portugal; Research Group ""Ageing C: Ageing Cluster"" - CINTESIS - Center for Health Technology and Services Research, Porto, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: odete.araujo@ese.uminho.pt.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lage', 'Affiliation': 'School of Nursing, University of Minho, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: ilage@ese.uminho.pt.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cabrita', 'Affiliation': 'Faculty of Pharmacy, University of Lisbon, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal. Electronic address: jcabrita@ff.ul.pt.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua Jorge de Viterbo Ferreira 228, 4050-343 Porto, Portugal.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151280']
1523,32744862,"Effects of Interleukin-1β Inhibition on Incident Hip and Knee Replacement : Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Osteoarthritis is a common inflammatory disorder with no disease-modifying therapies. Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
OBJECTIVE


To determine whether IL-1β inhibition with canakinumab reduces incident total hip or knee replacement (THR/TKR).
DESIGN


Exploratory analysis of a randomized trial. (ClinicalTrials.gov: NCT01327846).
SETTING


1091 clinical sites in 39 countries.
PARTICIPANTS


10 061 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants.
INTERVENTION


Random allocation to placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months.
MEASUREMENTS


The primary and secondary outcomes were time to first incident THR/TKR and time to first occurrence of an osteoarthritis-related adverse event (AE). Data were obtained through blinded ascertainment of trial clinical and safety databases.
RESULTS


Median follow-up was 3.7 years. For the individual canakinumab dose groups, compared with placebo, hazard ratios (HRs) for incident THR/TKR during follow-up were 0.60 (95% CI, 0.38 to 0.95) for the 50-mg group, 0.53 (CI, 0.33 to 0.84) for the 150-mg group, and 0.60 (CI, 0.38 to 0.93) for the 300-mg group. Thus, in the pooled canakinumab groups, compared with the placebo group, incidence rates for THR/TKR were 0.31 and 0.54 events per 100 person-years (HR, 0.58 [CI, 0.42 to 0.80];  P  = 0.001), respectively. The HR for the secondary end point of osteoarthritis-related AEs was 0.73 (CI, 0.61 to 0.87). Similar findings were observed in analyses restricted to participants with a history of osteoarthritis.
LIMITATION


Because the parent trial was not designed to examine the efficacy of IL-1β inhibitors in osteoarthritis, information on structural joint outcomes was not collected.
CONCLUSION


Findings from this exploratory analysis of a randomized controlled trial support further investigation of IL-1β inhibition for treatment of large joint osteoarthritis.
PRIMARY FUNDING SOURCE


Novartis Pharmaceuticals.",2020,"Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
","['10\xa0061', '1091 clinical sites in 39 countries', 'Incident Hip and Knee Replacement']","['interleukin-1β (IL-1β', 'canakinumab', 'Placebo', 'placebo or canakinumab', 'placebo', 'Interleukin-1β Inhibition']","['hazard ratios (HRs) for incident THR/TKR', 'incidence rates for THR/TKR', 'structural joint outcomes', 'time to first incident THR/TKR and time to first occurrence of an osteoarthritis-related adverse event (AE']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.513316,"Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schieker', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland, and Ludwig Maximilian University of Munich, Munich, Germany (M.S.).'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health Research Leeds BiomedicalResearch Centre, Leeds, United Kingdom (P.G.C.).'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mindeholm', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Praestgaard', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., P.M.R.).""}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Scotti', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Gram', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland (T.T.).'}, {'ForeName': 'Ronenn', 'Initials': 'R', 'LastName': 'Roubenoff', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., P.M.R.).""}]",Annals of internal medicine,['10.7326/M20-0527']
1524,32753452,FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care.,"INTRODUCTION


Even though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.
METHODS AND ANALYSIS


We will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one sided) to exclude the prespecified non-inferiority margin of HR of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations.
ETHICS AND DISSEMINATION


This master protocol received favourable ethical opinion from National Health Service East of England-Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN60048867.",2020,"Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months).","['600 patients in each', 'participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units', 'Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72\u2009hours of extubation following a period of invasive ventilation (step-down RCT', 'critically ill children']","['RCT', 'FIRST-line support', 'high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP', 'HFNC']",['time to liberation from respiratory support for a continuous period of 48\u2009hours'],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C1627345', 'cui_str': 'Stepdown unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",,0.253144,"Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months).","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': 'Paediatric Intensive Care, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Drikite', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feltbower', 'Affiliation': 'Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Parent representative, Sussex, UK.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care Unit, Birmingham Women's and Children's Hospitals NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital For Children NHS Trust, London, UK.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'School of Health and Society, University of Salford, Salford, Greater Manchester, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital For Children NHS Trust, London, UK p.ramnarayan@gosh.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2020-038002']
1525,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1526,32757065,Effect of carbohydrate-protein supplementation on endurance training adaptations.,"PURPOSE


To examine the influence of post-exercise protein feeding upon the adaptive response to endurance exercise training.
METHODS


In a randomised parallel group design, 25 healthy men and women completed 6 weeks of endurance exercise training by running on a treadmill for 30-60 min at 70-75% maximal oxygen uptake (VO 2max ) 4 times/week. Participants ingested 1.6 g per kilogram of body mass (g kg BM -1 ) of carbohydrate (CHO) or an isocaloric carbohydrate-protein solution (CHO-P; 0.8 g carbohydrate kg BM -1  + 0.8 g protein kg BM -1 ) immediately and 1 h post-exercise. Expired gas, blood and muscle biopsy samples were taken at baseline and follow-up.
RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 L min -1  and 3.0 ± 2 mL kg -1  min -1 , respectively). No change occurred in plasma albumin concentration from baseline to follow-up with CHO-P (4.18 ± 0.18 to 4.23 ± 0.17 g dL -1 ) or CHO (4.17 ± 0.17 to 4.12 ± 0.22 g dL -1 ; interaction: p > 0.05). Mechanistic target of rapamycin (mTOR) gene expression was up-regulated in CHO-P (+ 46%; p = 0.025) relative to CHO (+ 4%) following exercise training.
CONCLUSION


Post-exercise protein supplementation up-regulated the expression of mTOR in skeletal muscle over 6 weeks of endurance exercise training. However, the magnitude of improvement in VO 2max  was similar between groups.",2020,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ",['25 healthy men and women completed 6\xa0weeks of'],"['endurance exercise training by running on a treadmill for 30-60\xa0min at 70-75% maximal oxygen uptake', 'endurance exercise training', 'carbohydrate (CHO', 'carbohydrate-protein supplementation', 'isocaloric carbohydrate-protein solution (CHO-P; 0.8\xa0g carbohydrate kg', 'L']","['BM -1', 'plasma albumin concentration', 'VO 2max', 'Mechanistic target of rapamycin (mTOR) gene expression', 'endurance training adaptations', 'Expired gas, blood and muscle biopsy samples']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",25.0,0.046735,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ","[{'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Alghannam', 'Affiliation': 'Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 84428, Saudi Arabia. AFAlghannam@pnu.edu.sa.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Jedrzejewski', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lemon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bilzon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04450-1']
1527,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1528,32757413,Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.,"OBJECTIVE


The objective of this study was to assess the efficacy and safety of nabilone, a synthetic tetrahydrocannabinol analogue, as a treatment for non-motor symptoms (NMS) in Parkinson's disease (PD).
METHODS


This was a phase II placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal trial conducted at the Medical University Innsbruck. A random sample of 47 patients with PD with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society - Unified PD Rating Scale-I (MDS-UPDRS-I) underwent open-label nabilone titration (0.25 mg once daily to 1 mg twice daily, phase I). Responders were randomized 1:1 to continue with nabilone or switch to placebo for 4 weeks (phase II). The primary efficacy criterion was the change of the MDS-UPDRS-I between randomization and week 4. Safety was analyzed in all patients who received at least one nabilone dose.
RESULTS


Between October 2017 and July 2019, 19 patients received either nabilone (median dose = 0.75 mg) or placebo. At week 4, mean change of the MDS-UPDRS-I was 2.63 (95% confidence interval [CI] 1.53 to 3.74, p = 0.002, effect size = 1.15) in the placebo versus 1.00 (95% CI -0.16 to 2.16, p = 0.280, effect size = 0.42) in the nabilone-group (difference: 1.63, 95% CI 0.09 to 3.18, p = 0.030, effect size = 0.66). Seventy-seven percent of patients had adverse events (AEs) during open-label titration, most of them were transient. In the double-blind phase, similar proportions of patients in each group had AEs (42% in the placebo group and 32% in the nabilone group). There were no serious AEs.
INTERPRETATION


Our results highlight the potential efficacy of nabilone for patients with PD with disturbing NMS, which appears to be driven by positive effects on anxious mood and night-time sleep problems.
TRIAL REGISTRY


ClinicalTrials.gov (NCT03769896) and EudraCT (2017-000192-86). ANN NEUROL 2020.",2020,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","['Between October 2017 and July 2019', '47 PD patients with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society-Unified PD Rating Scale-I (MDS-UPDRS-I) underwent', '2017-000192-86', 'non-motor symptoms (NMS) in Parkinson´s Disease (PD']","['nabilone or switch to placebo', 'open-label nabilone titration', 'EudraCT', 'placebo']","['Safety', 'effect', 'mean change of the MDS-UPDRS', 'adverse events (AEs', 'change of the MDS-UPDRS']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]","[{'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.706771,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Peball', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krismer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hans-Günther', 'Initials': 'HG', 'LastName': 'Knaus', 'Affiliation': 'Department for Medical Genetics, Molecular, and Clinical Pharmacology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Atbin', 'Initials': 'A', 'LastName': 'Djamshidian', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Werkmann', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Carbone', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ellmerer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Heim', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Marini', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Valent', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Ulmer', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Stockner', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Stolz', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Krejcy', 'Affiliation': 'AOP Orphan Pharmaceuticals AG, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Seppi', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25864']
1529,32759251,"Ursodeoxycholic acid as a novel disease-modifying treatment for Parkinson's disease: protocol for a two-centre, randomised, double-blind, placebo-controlled trial, The 'UP' study.","INTRODUCTION


There are no disease-modifying treatments for Parkinson's disease (PD). We undertook the first drug screen in PD patient tissue and idntified ursodeoxycholic acid (UDCA) as a promising mitochondrial rescue agent. The aims of this trial are to determine safety and tolerability of UDCA in PD at 30 mg/kg, confirm the target engagement of UDCA, apply a novel motion sensor-based approach to quantify disease progression objectively, and estimate the mean effect size and its variance on the change in motor severity.
METHODS AND ANALYSIS


This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD. Treatment duration is 48 weeks, followed by an 8-week washout phase. Randomisation is 2:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48 and 56. The primary outcome is safety and tolerability. Secondary outcomes will compare the change between baseline and week 48 using the following three approaches: the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 in the practically defined 'OFF' medication state; confirmation of target engagement, applying  31 Phosphorus MR Spectroscopy to assess the levels of ATP and relevant metabolites in the brain; and objective quantification of motor impairment, using a validated, motion sensor-based approach. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups. For each secondary outcome, the change from baseline will be summarised within treatment groups using summary statistics and appropriate statistical tests assessing for significant differences. All outcomes will use an intention-to-treat analysis population.
ETHICS AND DISSEMINATION


This trial has been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics committee. Results will be disseminated in peer-reviewed journals, presentations at scientific meetings and to patients in a lay-summary format.
TRIAL REGISTRATION NUMBER


NCT03840005.",2020,"This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD.","[""Parkinson's disease"", '30 participants with early PD']","['Ursodeoxycholic acid', 'UDCA', 'ursodeoxycholic acid (UDCA', 'placebo']","[""Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 in the practically defined 'OFF' medication state; confirmation of target engagement, applying  31 Phosphorus MR Spectroscopy to assess the levels of ATP and relevant metabolites in the brain; and objective quantification of motor impairment, using a validated, motion sensor-based approach"", 'safety and tolerability']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.546511,"This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Payne', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Sassani', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Buckley', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moll', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Appleby', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Maru', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alisdair', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hoggard', 'Affiliation': 'Academic Unit of Radiology, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'Institute for In Silico Medicine, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Iain D', 'Initials': 'ID', 'LastName': 'Wilkinson', 'Affiliation': 'Academic Unit of Radiology, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bandmann', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK o.bandmann@sheffield.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-038911']
1530,32760097,Motor control integrated into muscle strengthening exercises has more effects on scapular muscle activities and joint range of motion before initiation of radiotherapy in oral cancer survivors with neck dissection: A randomized controlled trial.,"BACKGROUND


Accessory nerve shoulder dysfunction is common after neck dissection in oral cancer survivors. This study aimed to investigate the short-term effects of scapular muscle strengthening exercises with motor-control techniques on neck dissection-related shoulder dysfunction in oral cancer survivors before the initiation of radiotherapy.
METHODS


Thirty-eight participants were randomly allocated into the motor-control and regular-exercise groups. Each group received conventional physical therapy and specific scapular muscle strengthening exercises for 1 month immediately after neck dissection. Motor control techniques were integrated with scapular strengthening exercises for the motor-control group. Shoulder pain, active range of motion (AROM) of shoulder abduction, and scapular muscle activities including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) when performing maximal voluntary isometric contraction (MVIC) and scapular muscle exercises were evaluated at baseline and after 1 month of training.
RESULTS


Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention. Increased AROM of shoulder abduction was only observed in the motor-control group (95% CI 3.80 to 20.51, p = 0.004). Relative to baseline evaluation, muscle activities of UT decreased in the motor-control group when performing shoulder shrug with 1-kg weight (95% CI -33.06 to -1.29, p = 0.034). Moreover, the SA activity decreased in the motor-control group (95% CI -29.73 to -27.68, p<0.001) but increased in the regular-exercise group (95% CI 28.16 to 30.05, p<0.001) when performing shoulder horizontal adduction and flexion.
CONCLUSION


Early strengthening exercise with motor control techniques has greater benefits for improving AROM of shoulder abduction, muscle economy, and reducing compensatory scapular muscle activities in patients with neck dissection-related shoulder dysfunction before the initiation of radiotherapy.",2020,Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention.,"['oral cancer survivors with neck dissection', 'oral cancer survivors', 'Thirty-eight participants', 'patients with neck dissection-related shoulder dysfunction']","['scapular strengthening exercises', 'radiotherapy', 'Early strengthening exercise with motor control techniques', 'Motor control integrated into muscle strengthening exercises', 'conventional physical therapy and specific scapular muscle strengthening exercises', 'scapular muscle strengthening exercises with motor-control techniques', 'motor-control and regular-exercise groups']","['muscle activities of UT', 'Shoulder pain, active range of motion (AROM) of shoulder abduction, and scapular muscle activities including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA', 'shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC', 'SA activity', 'Increased AROM of shoulder abduction', 'maximal voluntary isometric contraction (MVIC) and scapular muscle exercises']","[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",38.0,0.090319,Both groups reduced shoulder pain and increased muscle activity of maximum voluntary isometric contraction (MVIC) of each muscle after the intervention.,"[{'ForeName': 'Yueh-Hsia', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Rung', 'Initials': 'CR', 'LastName': 'Lin', 'Affiliation': 'Rehabilitation Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Taiwan.'}, {'ForeName': 'Wei-An', 'Initials': 'WA', 'LastName': 'Liang', 'Affiliation': 'Rehabilitation Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Taiwan.'}, {'ForeName': 'Cheng-Ya', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0237133']
1531,32760148,Breastfeeding peer support by telephone in the RUBY randomised controlled trial: A qualitative exploration of volunteers' experiences.,"BACKGROUND


There is growing evidence that peer support programs may be effective in supporting breastfeeding mothers. A randomised controlled trial (RCT) (the RUBY study) that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
METHODS


This qualitative sub-study of the RUBY RCT explores the experiences and views of peer volunteers who delivered the intervention. Focus groups were conducted with 17 peers from the RUBY RCT between November 2015 and March 2016. All had provided peer support to at least one mother.
RESULTS


We found that volunteers identified strongly with the mothers' need for support when establishing breastfeeding. Key components of the support were strengthening the mothers' self-belief through affirmation and sharing experiential knowledge. Volunteers found the role rewarding and personally therapeutic although some women reported challenges initiating and maintaining contact with some mothers. Data were analysed using a hybrid approach to thematic analysis combining inductive and deductive techniques.
CONCLUSIONS


Breastfeeding peer support programs are reliant on recruitment of motivated volunteers who can provide empathetic mother-to-mother support. This study provides important information regarding volunteers' experiences that may support the upscaling of breastfeeding peer support for new mothers.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN 12612001024831.",2020,"that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
","['Focus groups were conducted with 17 peers from the RUBY RCT between November 2015 and March 2016', ""volunteers' experiences""]","['RUBY RCT', 'proactive telephone']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],,0.0535925,"that tested peer support in the Australian context found that infants of first-time mothers who received proactive telephone peer support were more likely to be receiving breastmilk at six months of age.
","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Grimes', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Della A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Touran', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Amir', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McLardie-Hore', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Victoria, Australia.'}]",PloS one,['10.1371/journal.pone.0237190']
1532,32761316,Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial.,"PURPOSE


The harms caused by excessive perioperative intravenous (IV) fluid administration are both well recognized and avoidable. The purpose of this study was to compare the incidence of excess intraoperative fluid administration in pediatric dental surgery patients when either an automated pump-delivery device or a manual gravity-drip device is used.
METHODS


We randomly assigned American Society of Anesthesiologists physical status I and II pediatric dental surgery patients to receive IV fluid via either a manual gravity-drip or automated pump-delivery device. Prior to each case, the attending anesthesiologist determined the target volume of maintenance IV fluid to be administered based on patient weight, estimated fluid deficits, and expected case length. The intraoperative IV fluid delivered was determined at the end of the case by the change in the IV bag weight. The primary outcome was the proportion of procedures that delivered ≥ 10% of the target IV fluid volume.
RESULTS


We recruited 105 children aged two to 12 yr (n = 49 in the automated pump-delivery device; n = 53 in the manual gravity-drip device). The proportion of excessive fluid administration was 8/49 (16%) in the automated pump-delivery device group compared with 33/53 (62%) in the gravity-drip group (relative risk of excessive fluid administration, 0.26; 95% confidence interval, 0.13 to 0.51; P < 0.001).
CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT03312452); registered 17 October 2017.",2020,"CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
","['I and II pediatric dental surgery patients', 'pediatric dental surgery', 'pediatric dental surgery patients', '105 children aged two to 12 yr (n = 49 in the automated pump-delivery device; n = 53 in the manual gravity-drip device']","['IV fluid via either a manual gravity-drip or automated pump-delivery device', 'automated pump-delivery device or a manual gravity-drip device']","['proportion of excessive fluid administration', 'proportion of procedures that delivered ≥ 10% of the target IV fluid volume']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",105.0,0.554494,"CONCLUSION


Intraoperative fluid administration using an automated pump-delivery device decreased the incidence of excessive IV fluid administration in pediatric dental surgery patients.
","[{'ForeName': 'Duncan E', 'Initials': 'DE', 'LastName': 'Bowes', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada. Duncan.Bowes@usask.ca.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Gamble', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Jagmeet S', 'Initials': 'JS', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01776-4']
1533,32761987,Remote skin self-examination training of melanoma survivors and their skin check partners: A randomized trial and comparison with in-person training.,"BACKGROUND


Compared with other cancers, melanoma has the longest delays measured as the median time to patient presentation for care from symptom onset. Time to presentation for care is a key determinant of outcomes, including disease stage, prognosis, and treatment.
METHODS


Melanoma survivors with localized disease and their skin check partners enrolled in two sequential randomized control trials of skin self-examination (SSE) training. In Phase 1, the pair read a workbook in the office and had quarterly total body skin examinations with a study dermatologist. In Phase 2, materials were mailed to pairs, whose surveillance was with a community physician. SSE knowledge, performance (frequency and extent), and identification of concerning moles were compared between phases.
RESULTS


Among 341 patients, 197 received the workbook and the others were controls. Knowledge in performing SSE was higher for the workbook relative to controls in both phases. The SSE frequency ranged from 2.38 to 5.97 times in 9 months. Patients randomized to the workbook in both phases performed significantly more SSE than controls at 9 months (P < .05). In both phases, trained survivors performed significantly more SSEs on the scalp than controls at 9 and 18 months (P < .05). Phase 1 survivors performed significantly more SSEs on the abdomen, buttocks, and soles of the feet than controls, but this did not occur in Phase 2. Finally, in both phases, survivors trained with the workbook resulted in greater detection of suspicious lesions and melanomas.
CONCLUSIONS


These findings justify the benefits of remote SSE training for patients as an adjunct to provider-administered screening.",2020,Patients randomized to the workbook in both phases performed significantly more SSE than controls at 9 months (P < .05).,"['341 patients, 197 received the workbook and the others were controls', 'Melanoma survivors with localized disease and their skin check partners', 'melanoma survivors and their skin check partners']","['remote SSE training', 'Remote skin self-examination training', 'skin self-examination (SSE) training']","['SSEs on the abdomen, buttocks, and soles of the feet', 'detection of suspicious lesions and melanomas', 'SSE knowledge, performance (frequency and extent), and identification of concerning moles', 'SSE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0277565', 'cui_str': 'Local disease'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0006497', 'cui_str': 'Buttock structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0027960', 'cui_str': 'Nevi'}]",341.0,0.0264083,Patients randomized to the workbook in both phases performed significantly more SSE than controls at 9 months (P < .05).,"[{'ForeName': 'June K', 'Initials': 'JK', 'LastName': 'Robinson', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Racheal', 'Initials': 'R', 'LastName': 'Reavy', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Mallett', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, PA, USA.'}]",Cancer medicine,['10.1002/cam4.3299']
1534,32762012,Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial.,"BACKGROUND


Acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) aims to improve cosmetic outcomes. Six-month data are presented from a randomized trial evaluating whether IBBR with ADM provides higher health-related quality of life (HRQoL) and patient-reported cosmetic outcomes compared with conventional IBBR without ADM.
METHODS


In this multicentre open-label RCT, women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK were allocated randomly (1 : 1) to IBBR with or without ADM. HRQoL, a secondary endpoint, was measured as patient-reported outcome measures (PROMs) using three validated instruments (EORTC-QLQC30, QLQ-BR23, QLQ-BRR26) at baseline and 6 months.
RESULTS


Between 24 April 2014 and 10 May 2017, 135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis. At 6 months after surgery, patient-reported HRQoL, measured with generic QLQ-C30 or breast cancer-specific QLQ-BR23, was similar between the groups. For patient-reported cosmetic outcomes, two subscale items, cosmetic outcome (8·66, 95 per cent c.i. 0·46 to 16·86; P = 0·041) and problems finding a well-fitting bra (-13·21, -25·54 to -0·89; P = 0·038), yielded higher scores in favour of ADM, corresponding to a small to moderate clinical difference. None of the other 27 domains measured showed any significant differences between the groups.
CONCLUSION


IBBR with ADM was not superior in terms of higher levels of HRQoL compared with IBBR without ADM. Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months. Registration number: NCT02061527 ( www.clinicaltrials.gov).",2020,"Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months.","['women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK', 'Between 24 April 2014 and 10 May 2017', '135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis']","['Acellular dermal matrix (ADM', 'IBBR with or without ADM', 'IBBR with ADM', 'implant-based breast reconstruction with or without acellular dermal matrix']","['health-related quality of life (HRQoL', 'Quality of life and patient satisfaction', 'generic QLQ-C30 or breast cancer-specific QLQ-BR23', 'validated instruments (EORTC-QLQC30, QLQ-BR23, QLQ-BRR26', 'problems finding a well-fitting bra ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]",135.0,0.156471,"Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lohmander', 'Affiliation': 'Department of Breast and Endocrine Surgery, Section of Breast Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lagergren', 'Affiliation': 'Department of Surgery, Breast Centre, Capio St Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Cancer Centre, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Roy', 'Affiliation': 'Department of Breast Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Frisell', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Cancer Centre, Karolinska Institutet, Stockholm, Sweden.'}]",BJS open,['10.1002/bjs5.50324']
1535,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1536,32759074,Auricular acupuncture for the treatment of nonepileptic seizures: A pilot study.,"OBJECTIVE


The aim of this pilot study was to examine the safety and tolerability of an eight-week treatment of twice weekly auricular acupuncture as a therapeutic intervention for the treatment of psychogenic nonepileptic seizures (PNES). The secondary aim was to determine if auricular acupuncture was effective at reducing PNES event frequency. Psychogenic nonepileptic seizures are as common as multiple sclerosis and are highly resistant to intervention. Unfortunately, there is no standard of care therapy, although mental health treatment referrals are commonly made. Acupuncture is felt to be a safe and cost-effective treatment for many diseases and symptoms including mental health disorders such as posttraumatic stress disorder (PTSD), anxiety, and conversion disorders. We propose to examine auricular acupuncture as a treatment for PNES.
METHODS


A single-center, 16-week trial of auricular acupuncture was designed: a four-week baseline period, followed by an eight-week active treatment period during which subjects received twice weekly auricular acupuncture, then followed by a four-week washout period. Tolerability was defined as completion of 12 of 16 treatments. Successful compliance with seizure diary was defined as >80%, or 100 of 120 days completed. Safety profile was established and seizure count per week was also calculated.
RESULTS


A total of 29 subjects enrolled from a consecutive sample of 73 PNES diagnoses discharging from our epilepsy unit. Twenty-two subjects entered the study with 91% completing more than 12 of 16 treatments, 91% meeting the endpoint of completing >80% of diary entries. Adverse events were mild, and only two subjects were withdrawn due to increased PNES frequency. Although short-term in design, using one-way repeated measures analysis of variance (ANOVA), we observed a statistically significant reduction in seizure count from baseline at treatment month one, treatment month two, and at the washout period (p = 0.0083). Eleven of 12 subjects (52.3%) who received at least one treatment recorded a 50% frequency reduction. Three of 21 subjects (14%) were PNES-free at the end of the study.
SIGNIFICANCE


Auricular acupuncture is well-tolerated in a population with PNES and exhibits similar event frequency reductions as cognitive behavioral therapy (CBT). We believe that this is the first literature report examining auricular acupuncture for the treatment of PNES.",2020,"SIGNIFICANCE


Auricular acupuncture is well-tolerated in a population with PNES and exhibits similar event frequency reductions as cognitive behavioral therapy (CBT).","['psychogenic nonepileptic seizures (PNES', 'Twenty-two subjects entered the study with 91% completing more than 12 of 16 treatments, 91% meeting the endpoint of completing >80% of diary entries', 'nonepileptic seizures', 'A total of 29 subjects enrolled from a consecutive sample of 73 PNES diagnoses discharging from our epilepsy unit', 'Three of 21 subjects (14%) were PNES-free at the end of the study']","['auricular acupuncture', 'Acupuncture', 'Auricular acupuncture']","['Adverse events', 'Psychogenic nonepileptic seizures', 'safety and tolerability', 'Tolerability', 'seizure count']","[{'cui': 'C0458006', 'cui_str': 'Psychogenic'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",29.0,0.0284195,"SIGNIFICANCE


Auricular acupuncture is well-tolerated in a population with PNES and exhibits similar event frequency reductions as cognitive behavioral therapy (CBT).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Maa', 'Affiliation': 'Denver Health Medical Center, 777 Bannock Street, Denver, CO 80204, United States of America; University of Colorado, 12401 E. 17th Avenue Mail Stop F782, Aurora, CO 80045, United States of America. Electronic address: Edward.maa@dhha.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Applegate', 'Affiliation': 'St. Joseph Hospital, 1375 E. 19th Avenue, Denver, CO 80218, United States of America. Electronic address: Matt.Applegate@sclhealth.org.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keniston', 'Affiliation': 'University of Colorado, 12401 E. 17th Avenue Mail Stop F782, Aurora, CO 80045, United States of America. Electronic address: Angela.keniston@cuanschutz.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107329']
1537,32763106,Comment on: Bariatric surgery in the elderly: a randomized prospective study comparing safety of sleeve gastrectomy and Roux-en-Y gastric bypass (BASE Trial).,,2020,,['elderly'],"['sleeve gastrectomy and Roux-en-Y gastric bypass', 'Bariatric surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]",[],,0.0107772,,"[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Lo Menzo', 'Affiliation': 'The Bariatric And Metabolic Institute, Cleveland Clinic Florida, Weston, Florida.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.06.048']
1538,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1539,32764830,Exploring collective emotion transmission in face-to-face interactions.,"Collective emotion is the synchronous convergence of an effective response across individuals toward a specific event or object. Previous studies have focused on the transmission of cyber collective emotion; however, little attention has been paid to the transmission of collective emotion in face-to-face interactions. Using an experimental design, we examined how emotions are transmitted from some members to the whole group in face-to-face situations. We used a news report of a social event as an emotion stimulus to induce anger and disgust in 158 middle school students aged 12 to 15, with an average age of 13.20 years (SD = 0.651) We randomly assigned one-third of the participants to be ""transmitters,"" while the others were ""receivers."" Transmitters shared their feelings with receivers; then, receivers communicated with other group members. The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion. It accumulated through the effect of an emotional circle, during which the feedback reinforced emotion intensity. The collective emotion transmission model comprised emotion diffusion, contagion, and accumulation. This model elucidates the intrinsic features of collective emotion transmission, enriches the research on collective emotion, and provides theoretical references for monitoring and managing future public events.",2020,"The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion.","['158 middle school students aged 12 to 15, with an average age of 13.20 years (SD = 0.651']","['transmitters,"" while the others were ""receivers']",['negative collective emotions'],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",158.0,0.0145015,"The results indicated that negative collective emotions were transmitted from high- to low-intensity members, which converged through the effect of emotional contagion.","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}, {'ForeName': 'Ailin', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Capital Normal University, Beijing, China.'}, {'ForeName': 'Kaiping', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Department of Psychology, Weiqing Building, Tsinghua University, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0236953']
1540,32759239,"Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial.","INTRODUCTION


Neurogenic bladder dysfunction is prevalent in female patients with spinal cord injury (SCI), and previous guidelines have recommended pelvic floor muscle training (PFMT) for first-line conservative treatment. However, the actual regimen of PFMT varies widely and the single treatment does not satisfy the need of some patients. Therefore, this study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for neurogenic bladder dysfunction.
METHODS AND ANALYSIS


This trial is a single-centre randomised controlled trial for female patients with urinary incontinence (UI) in phase of chronic SCI. Eligible participants will be randomised to one of four arms: (1) PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS. There will be 44 participants in each arm and all the subjects will undergo 20 treatment sessions, five times a week for 4 weeks. The outcomes will be evaluated at 4 weeks, 3 months and 6 months after randomisation. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
ETHICS AND DISSEMINATION


The Clinical Research and Biomedical Ethics Committee of the West China Hospital, Sichuan University has approved this trial and the approval number is 2019-885. All participants will be provided written informed consent after verification of the eligibility criteria. The results of this study will be accessible in peer-reviewed publications and be presented at academic conferences.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900026126).",2020,"The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
","['female patients with spinal cord injury (SCI', 'female neurogenic bladder dysfunction after spinal cord injury', 'female patients with urinary incontinence (UI) in phase of chronic SCI']","['biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training', 'PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS', 'PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS', 'PFMT']","['International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",,0.208539,"The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Chenying', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Chengqi', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China weiquan@scu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-034582']
1541,32764077,θ-γ Cross-Frequency Transcranial Alternating Current Stimulation over the Trough Impairs Cognitive Control.,"Cognitive control is a mental process, which underlies adaptive goal-directed decisions. Previous studies have linked cognitive control to electrophysiological fluctuations in the θ band and θ-γ cross-frequency coupling (CFC) arising from the cingulate and frontal cortices. However, to date, the behavioral consequences of different forms of θ-γ CFC remain elusive. Here, we studied the behavioral effects of the θ-γ CFC via transcranial alternating current stimulation (tACS) designed to stimulate the frontal and cingulate cortices in humans. Using a double-blind, randomized, repeated measures study design, 24 healthy participants were subjected to three active and one control CFC-tACS conditions. In the active conditions, 80-Hz γ tACS was coupled to 4-Hz θ tACS. Specifically, in two of the active conditions, short γ bursts were coupled to the delivered θ cycle to coincide with either its peaks or troughs. In the third active condition, the phase of a θ cycle modulated the amplitude of the γ oscillation. In the fourth, control protocol, 80-Hz tACS was continuously superimposed over the 4-Hz tACS, therefore lacking any phase specificity in the CFC. During the 20 min of stimulation, the participants performed a Go/NoGo monetary reward-based and punishment-based instrumental learning task. A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials. Our results suggest that cognitive control depends on the phase specificity of the θ-γ CFC.",2020,"A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials.","['24 healthy participants were subjected to three active and one control CFC-tACS conditions', 'humans']","['theta-gamma CFC via transcranial alternating current stimulation (tACS', 'gamma tACS', 'Go/NoGo monetary reward- and punishment-based instrumental learning task']",['behavioral performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009651', 'cui_str': 'Operant conditioning'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",24.0,0.0618721,"A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials.","[{'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Turi', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany zsoltturi@gmail.com matthias.mittner@uit.no.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mittner', 'Affiliation': 'Department of Psychology, UiT The Arctic University of Norway, 9037 zsoltturi@gmail.com matthias.mittner@uit.no.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lehr', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bürger', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antal', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}]",eNeuro,['10.1523/ENEURO.0126-20.2020']
1542,32764081,"Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.","OBJECTIVES


The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone.
DESIGN


A multicentre, randomised, controlled trial.
SETTING


Conducted at 11 Norwegian general practitioners' (GPs') offices.
PARTICIPANTS


171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded.
INTERVENTIONS


The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects.
RESULTS


185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported.
CONCLUSIONS


We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
TRIAL REGISTRATION NUMBER


NCT01439412.",2020,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","['Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded', '171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017', ""Conducted at 11 Norwegian general practitioners' (GPs') offices"", '14 participants did not receive the allocated intervention and 4 were excluded from the analysis', 'acute low back pain (ALBP', '167 participants were included in the analysis, 86 in the CG and 81 in the AG', 'acute non-specific low back pain', '185 participants were randomised, 95 in the CG and 90 in the AG']","['acupuncture', 'Acupuncture', 'control group (CG) or the acupuncture group (AG) by online software']","['median days to recovery', 'time-to-recovery', 'pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects', 'median time to recovery', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",167.0,0.197259,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","[{'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Skonnord', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway trygve.skonnord@medisin.uio.no.'}, {'ForeName': 'Holgeir', 'Initials': 'H', 'LastName': 'Skjeie', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Brekke', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Klovning', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fetveit', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-034157']
1543,32764089,Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.,"INTRODUCTION


This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol.
METHODS AND DESIGN


The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020.
PRIMARY OUTCOME MEASURE


30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days.
SECONDARY OUTCOME MEASURES


proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation.
ETHICS AND DISSEMINATION


The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03906500.",2020,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"['Danish high schools', 'Target group: first year high school students', 'Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019', 'random sample of 16 high schools', 'high school students in Denmark']","[""school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol"", ""High schools High on life' intervention"", 'school-based intervention']","['proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake', 'mean number of binge-drinking episodes ']","[{'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",16.0,0.0307791,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"[{'ForeName': 'Veronica Sofie Clara', 'Initials': 'VSC', 'LastName': 'Pisinger', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark vepi@sdu.dk.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hoffmann', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Johanne Aviaja', 'Initials': 'JA', 'LastName': 'Rosing', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Grønbæk', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Lau', 'Initials': 'L', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krølner', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-038857']
1544,32767806,R-CHOP-14 versus R-CHOP-14/CHASER for upfront autologous transplantation in diffuse large B-cell lymphoma: JCOG0908 study.,"The efficiency of upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT) for newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL) may be influenced by induction chemotherapy. To select better induction chemotherapy regimens for HDCT/ASCT, a randomized phase II study was conducted in high-risk DLBCL patients having an age-adjusted International Prognostic Index (aaIPI) score of 2 or 3. As induction chemotherapy, 6 cycles of R-CHOP-14 (arm A) or 3 cycles of R-CHOP-14 followed by 3 cycles of CHASER (arm B) were planned, and patients who responded proceeded to HDCT with LEED and ASCT. The primary endpoint was 2-y progression-free survival (PFS), and the main secondary endpoints included overall survival, overall response rate, and adverse events (AEs). In total, 71 patients were enrolled. With a median follow-up of 40.3 mo, 2-y PFS in arms A and B were 68.6% (95% confidence interval [CI], 50.5%-81.2%) and 66.7% (95% CI: 48.8%-79.5%), respectively. Overall survival at 2 y in arms A and B was 74.3% (95% CI: 56.4%-85.7%) and 83.3% (95% CI: 66.6%-92.1%). Overall response rates were 82.9% in arm A and 69.4% in arm B. During induction chemotherapy, 45.7% and 75.0% of patients in arms A and B, respectively, had grade ≥ 3 non-hematologic toxicities. One patient in arm A and 6 in arm B discontinued induction chemotherapy due to AEs. In conclusion, R-CHOP-14 showed higher 2-y PFS and less toxicity compared with R-CHOP-14/CHASER in patients with high-risk DLBCL, suggesting the former to be a more promising induction regimen for further investigations (UMIN-CTR, UMIN000003823).",2020,"Overall survival at 2 years in arms A and B were 74.3% (95% CI, 56.4-85.7%) and 83.3% (95% CI, 66.6-92.1%).","['71 patients were enrolled', 'high-risk DLBCL patients with age-adjusted International Prognostic Index (aaIPI) score 2 or 3', 'newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL']","['upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT', 'HDCT with LEED and ASCT']","['grade ≥3 non-hematologic toxicities', '2-year PFS', 'Overall survival', '2-year progression-free survival (PFS', '2-year PFS and less toxicity', 'Overall response rates', 'overall survival, overall response rate, and adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",71.0,0.277288,"Overall survival at 2 years in arms A and B were 74.3% (95% CI, 56.4-85.7%) and 83.3% (95% CI, 66.6-92.1%).","[{'ForeName': 'Yoshitoyo', 'Initials': 'Y', 'LastName': 'Kagami', 'Affiliation': 'Department of Hematology, Toyota Kosei Hospital, Toyota, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Imaizumi', 'Affiliation': 'Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Minauchi', 'Affiliation': 'Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Hematology, Saitama Cancer Center, Ina-cho, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Hematology, National Cancer Center East, Kashiwa, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tsujimura', 'Affiliation': 'Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hangaishi', 'Affiliation': 'Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tominaga', 'Affiliation': 'Division of Hematology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Youko', 'Initials': 'Y', 'LastName': 'Suehiro', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Michihide', 'Initials': 'M', 'LastName': 'Tokuhira', 'Affiliation': 'Departments of Hematology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yakushijin', 'Affiliation': 'First Department of Internal Medicine, Ehime University Hospital, Toon, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Kisato', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Morishima', 'Affiliation': 'Second Department of Internal Medicine, University of the Ryukyus Hospital, Nishihara, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomomitsu', 'Initials': 'T', 'LastName': 'Hotta', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, International Medical Center, Saitama Medical University, Hidaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",Cancer science,['10.1111/cas.14604']
1545,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1546,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1547,32728763,Anthropometric Aspects in the Breast Augmentation.,"BACKGROUND


Studies have demonstrated the importance of anthropometric measurements of the breasts, based on linear measurements for the selection of the volume of breast implants, their positioning, and surgical planning.
OBJECTIVES


The objective of this study is to evaluate the main changes in anthropometric measurements in breast augmentation.
METHODS


A prospective, randomized clinical study with 74 female candidates for breast augmentation. All the individuals were split into five groups, according to the implant volume. The implants used were of different textures, from three different brands (LifeSil, Politech, and Silimed). The following measures were taken: distance from the nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection.
RESULTS


The most significant breast anthropometric alteration after mammoplasty was the N-IMF distance; that is, an expansion of the lower pole of the breast, followed by an increase in the areolar diameter. Mostly of measurements showed stability between 3rd and 6th months after the surgery. The projection was the most interesting measure due to presenting two patterns of behavior according to the analysis criteria performed. When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
CONCLUSIONS


This study provides an essential comparative analysis between anthropometric changes in breast augmentations and serves as a predictive tool in the preoperative evaluation of the patient during surgical planning.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
",['74 female candidates for breast augmentation'],['IV'],"['nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]",[],"[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0442099', 'cui_str': 'Inframammary'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",74.0,0.034736,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Charles-de-Sá', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil. clinicaperforma@uol.com.br.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'de Aguiar Valladão', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'Diogo Maciel Lobão', 'Initials': 'DML', 'LastName': 'Vieira', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'José Horácio', 'Initials': 'JH', 'LastName': 'Aboudib', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01853-5']
1548,32769027,Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials.,"BACKGROUND


Depression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP.
METHODS


A sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m 2 ; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms.
RESULTS


The change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (-10.0, 95% CI -18.3 to -1.8, p = 0.019).
CONCLUSIONS


Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.",2020,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","['OSA patients with higher depressive symptoms', '126 male OSA patients (age\xa0=\xa051\xa0±\xa011 years; BMI\xa0=\xa032.0\xa0±\xa05.1\xa0kg/m 2 ; apnea hypopnea index\xa0=\xa042.4\xa0±\xa022.6 events/hour', 'patients with baseline depressive symptoms', 'individuals with OSA', 'OSA patients', 'patients with obstructive sleep apnea (OSA']","['OSA with continuous positive airway pressure (CPAP', 'sham CPAP', 'CPAP', 'therapeutic CPAP']","['depression scores', 'Depression, Anxiety and Stress Scale (DASS', 'change in DASSD', 'Depressive symptoms', 'DASSD scores', 'DASS depression score (DASSD', 'depressive symptoms']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",126.0,0.313538,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Department of Sleep Medicine, Surgery and Science, Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, USA.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; School of Psychology, Brain and Mind Centre and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: camilla.hoyos@sydney.edu.au.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.021']
1549,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1550,32766863,Community delivery of brief therapy for depressed older adults impacted by Hurricane Sandy.,"Older adults frequently under-report depressive symptoms and often fail to access services after a disaster. To address unmet mental health needs, we developed a service delivery program (SMART-MH) that combines outreach, assessment, and therapy and implemented it in New York City after Hurricane Sandy. This study aimed to examine the feasibility, effectiveness, and patients' engagement of our brief psychotherapy (""Engage""). We predicted that Engage would result in reductions of depression, and that the benefits would be comparable to those of a historical comparison group who received Engage in a controlled experimental setting. A total of 2,831 adults (age ≥ 60) impacted by Hurricane Sandy were screened for depression. Assessments and therapy were conducted in English, Spanish, Cantonese, and Russian. Depressed individuals (PHQ-9 ≥ 10) who were not in treatment were offered Engage therapy in their native language at local senior center/nutrition sites. Twelve percent of the participants reported depression (N = 333). Of these 333 participants, 201 (60%) were not receiving treatment and 143 agreed to receive Engage therapy. Linear mixed-effects model showed that depression severity decreased significantly over time. More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9. Post-hoc comparison of standardized slopes of change found patterns of depression reductions equivalent to Engage provided in a controlled setting. Partnerships to integrate mental health care into community settings can increase detection of mental-health needs and access to services in patients' native language. Brief reward exposure-based psychotherapy delivered in the community can provide comparable benefits to those achieved in research settings.",2020,More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9.,"['depressed older adults impacted by Hurricane Sandy', '333 participants, 201 (60%) were not receiving treatment and 143 agreed to receive Engage therapy', 'Depressed individuals (PHQ-9 ≥ 10) who were not in treatment were offered Engage therapy in their native language at local senior center/nutrition sites', ""patients' native language"", 'Older adults', '2,831 adults (age ≥ 60) impacted by Hurricane Sandy were screened for depression']",['Brief reward exposure-based psychotherapy'],"['depression severity', 'PHQ-9 scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0020183', 'cui_str': 'Hurricane'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2831.0,0.0336343,More than two thirds had a five-point reduction in PHQ-9 scores and post-treatment scores ≤9.,"[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Scher', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chalfin', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}, {'ForeName': 'Jacquelin', 'Initials': 'J', 'LastName': 'Berman', 'Affiliation': 'New York City Department for the Aging, New York, NY, USA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, White Plains, NY, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibz145']
1551,32768588,Evaluation of combined efficacy of photodynamic therapy using indocyanine green photosensitizer and non-surgical periodontal therapy on clinical and microbial parameters in the management of chronic periodontitis subjects: A randomized split-mouth design.,"BACKGROUND


The clinical efficacy of multiple applications of Photodynamic therapy (PDT) needs to be better investigated for the management of chronic periodontitis subjects.
AIM


The aim of this study was to evaluate the clinical and antimicrobial efficacy of multiple application of PDT as an adjunct to scaling and root planning in management of moderate periodontal pockets.
MATERIALS AND METHODS


33 patients with bilateral periodontal destruction in mandibular posterior sextants were randomly treated with either test (SRP + multiplePDT) or control (SRP) intervention. PDT was employed with diode laser(810 nm) and Indocyanine green(ICG) dye at baseline, 1 st, 2nd and 4th week post SRP. Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), gingival bleeding index (GBI) were recorded at baseline, 3 and 6 months. Subgingival plaque samples were analysed for Porphyromonas gingivalis (P.g), Aggregatibacter actinomycetemcomitans (A.a), Tannerella forsythia (T.f), Fusobacterium nucleatum (F.n), Treponema denticola (T.d).
RESULTS


Statistically significant improvement was noted in all clinical parameters in both the groups from baseline to 3 and 6 months. The mean PPD and CAL decreased in control sites from 5.83 ± 0.64 and 5.60 ± 0.72 at baseline to 3.80 ± 0.40 and 3.70 ± 0.91 at 6 months and in test sites from 5.93 ± 0.82 and 5.73 ± 0.69 to 3.40 ± 0.56 and 3.00 ± 0.91 at 6 months (P ≤ 0.05). Test sites showed significantly greater reduction in P.g, A.a, T.f, F.n and T.d compared to control sites at 3 and 6 months (P ≤ 0.05).
CONCLUSION


The outcomes suggested that adjunctive multiple applications of PDT to SRP shows significant reduction in periodontal pathogens over SRP alone.",2020,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), gingival bleeding index (GBI) were recorded at baseline, 3 and 6 months.","['chronic periodontitis subjects', '33 patients with bilateral periodontal destruction in mandibular posterior sextants']","['Photodynamic therapy (PDT', 'photodynamic therapy', 'PDT', 'Diode laser', 'test (SRP\u2009+\u2009multiplePDT) or control (SRP) intervention', 'indocyanine green photosensitizer and non-surgical periodontal therapy']","['mean PPD and CAL', 'Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), gingival bleeding index (GBI', 'Porphyromonas gingivalis (P.g), Aggregatibacter actinomycetemcomitans (A.a), Tannerella forsythia (T.f), Fusobacterium nucleatum (F.n), Treponema denticola (T.d', 'periodontal pathogens']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0236023', 'cui_str': 'Periodontal destruction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0085479', 'cui_str': 'Fusobacterium nucleatum'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",33.0,0.0339033,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), gingival bleeding index (GBI) were recorded at baseline, 3 and 6 months.","[{'ForeName': 'Kanchana', 'Initials': 'K', 'LastName': 'Sukumar', 'Affiliation': 'Department of Periodontics SRM Dental College, Ramapuram, Chennai, 600089, Tamilnadu, India. Electronic address: kancha1308@gmail.com.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Tadepalli', 'Affiliation': 'Department of Periodontics SRM Dental College, Ramapuram, Chennai, 600089, Tamilnadu, India. Electronic address: anupamamds@gmail.com.'}, {'ForeName': 'Harinath', 'Initials': 'H', 'LastName': 'Parthasarathy', 'Affiliation': 'Department of Periodontics SRM Dental College, Ramapuram, Chennai, 600089, Tamilnadu, India. Electronic address: hari_feb14@hotmail.com.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Ponnaiyan', 'Affiliation': 'Department of Periodontics SRM Dental College, Ramapuram, Chennai, 600089, Tamilnadu, India. Electronic address: deepa_ponnaiyan@yahoo.co.in.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101949']
1552,32770667,Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended-Release Tablets.,"Alfuzosin is a medication approved by the US Food and Drug Administration to treat benign prostatic hyperplasia symptoms. Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication. The aim of this study is to assess the bioavailability of the generic (test) and branded (reference) formulations of 10-mg alfuzosin extended-release tablets after oral administration to healthy adults under fed conditions. The study used a comparative randomized, single-dose, 2-way crossover open-label study design. Thirty-three participants were recruited and completed the clinical assessment. The pharmacokinetic parameters maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC 0-t  ), AUC extrapolated to infinity (AUC 0-∞  ), time to maximum concentration, and elimination half-life were estimated to prove bioequivalence. The confidence intervals for the log-transformed test/reference ratios for alfuzosin 110.7% (98.0-124.9) and 112.0% (101.9-123.1) for C max  and AUC 0-t  respectively, which are within the allowed limits specified by the regulatory authorities (80-125% for C max  and AUC 0-t  ). The test formulation can therefore be prescribed as an alternative to the reference for symptomatic treatment of benign prostatic hyperplasia.",2020,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"['Thirty-three participants were recruited and completed the clinical assessment', 'healthy adults under fed conditions']","['Alfuzosin Extended-Release Tablets', '10-mg alfuzosin', 'Alfuzosin', 'alfuzosin']","['pharmacokinetic parameters maximum plasma concentration (C max  ), area under the plasma concentration-time curve (AUC 0-t  ), AUC extrapolated to infinity (AUC 0-∞  ), time to maximum concentration, and elimination half-life']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",33.0,0.0447721,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"[{'ForeName': 'Abdel Qader', 'Initials': 'AQ', 'LastName': 'Al Bawab', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}, {'ForeName': 'Bashar A', 'Initials': 'BA', 'LastName': 'Alkhalidi', 'Affiliation': 'School of Pharmacy, The University of Jordan, Amman, Jordan.'}, {'ForeName': ""Esra'a"", 'Initials': 'E', 'LastName': 'Albarahmieh', 'Affiliation': 'School of Applied Medical Sciences, German Jordanian University, Amman, Jordan.'}, {'ForeName': 'Sami M A', 'Initials': 'SMA', 'LastName': 'Qassim', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammad A D', 'Initials': 'MAD', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Al-Qerem', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.860']
1553,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
1554,32778992,Integrating Tobacco Prevention Skills into an Evidence-Based Intervention for Adolescents with ADHD: Results from a Pilot Efficacy Randomized Controlled Trial.,"Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for tobacco use, but tobacco use prevention strategies are not regularly incorporated into evidence-based ADHD interventions. We conducted a pilot randomized-controlled trial to determine the feasibility of integrating tobacco use prevention skills into a behavioral treatment for ADHD and to provide preliminary efficacy data comparing a combined (ADHD + tobacco) intervention (N = 40) to an ADHD only intervention (N = 23) on tobacco risk outcomes. Sixty-three adolescents (72% male; 13-17 years) with ADHD and their caregivers were randomly assigned to condition and families were masked to condition. Parent and adolescent ratings were collected at baseline, immediate post-intervention, and at 3- and 9-month follow-up assessments. The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk. Relative to the ADHD intervention, the combined intervention buffered against increases in tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use. Effect sizes at post-treatment were in the small to moderate range. Overall, this study provides preliminary support for a parent-adolescent behavioral treatment supplemented with family-based tobacco prevention strategies. This approach targets families already in treatment for ADHD, reducing barriers that occur when families attend multi-session prevention programs in addition to ADHD treatment.",2020,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","['Adolescents with ADHD', 'Adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Sixty-three adolescents (72% male; 13-17\xa0years) with ADHD and their caregivers']",['combined (ADHD + tobacco) intervention'],"['tobacco risk, including reduced intentions to smoke and maladaptive social normative beliefs, and increased parental control, family cohesion, and family communication about substance use', 'Parent and adolescent ratings']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0726723,"The combined intervention was (1) implemented with high fidelity (94%), (2) well received by parents and adolescents as evidenced by high levels of treatment attendance (82%) and satisfaction with the intervention, and (3) associated with parent- and adolescent-reported reductions in tobacco use risk.","[{'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA. racorona@vcu.edu.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Romo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Parks', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Avila', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin Street, Box 842018, Richmond, VA, 23284-2018, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00689-6']
1555,32771011,Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 12-month implementation outcomes from a cluster randomized controlled trial.,"BACKGROUND


'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months.
METHODS


A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes.
RESULTS


Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15-1556.4], p < 0.001). The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both > 80%).
CONCLUSIONS


Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017.",2020,"The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)).","['secondary schools', 'Schools were recruited from May to November 2017', '49 randomly selected disadvantaged Australian Government and Catholic secondary schools']","['Physical Activity 4 Everyone (PA4E1) intervention', 'usual practice control (n\u2009=\u200925) or the PA4E1 program', 'PA4E1']","['proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",49.0,0.0969577,"The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Campbell', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia. Matthew.Mclaughlin1@health.nsw.gov.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nathan', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, NSW, 2300, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, NSW, 2300, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, 2308, Australia.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'South Western Sydney Local Health District, Locked Mail Bag 7279, Liverpool BC, NSW, 1871, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kajons', 'Affiliation': 'Central Coast Local Health District, 4-6 Watt Street, Gosford, NSW, 2250, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Mid North Coast Local Health District, P.O. Box 126, Port Macquarie, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'New South Wales Department of Education, School Sports Unit, Level 3, 1 Oxford Street, Darlinghurst, NSW, 2010, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McKenzie', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hollis', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01000-y']
1556,32771018,Effect of novel technology-enabled multidimensional physical activity feedback in primary care patients at risk of chronic disease - the MIPACT study: a randomised controlled trial.,"BACKGROUND


Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease.
METHODS


MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (≥10 and < 20%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n = 120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3 months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n = 84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12 months.
RESULTS


Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, - 17.9 to 15.7) min/day; moderate-vigorous physical activity in ≥10-min bouts: 0.2 (- 14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (- 0.036 to 0.054); vigorous physical activity: 1.8 (- 0.8 to 4.2) min/day; and sedentary time: 10 (- 19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions.
CONCLUSION


In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age.
TRIAL REGISTRATION


This trial is registered with the ISRCTN registry ( ISRCTN18008011 ; registration date 31 July 2013).",2020,"For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID).","['recruited patients at medium (≥10 and\u2009<\u200920%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom', 'primary care patients at risk of chronic disease - the MIPACT study', 'primary care patients identified as at risk of chronic disease', 'primary care patients, and practitioners']","['novel technology-enabled multidimensional physical activity feedback', 'novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support', 'personal multidimensional physical activity feedback using a customised digital system and web-app for 3\u2009months plus five health trainer-led sessions']","['vigorous physical activity', 'physical activity multidimensionality', 'Physical Activity Level (PAL', 'mean physical activity', 'moderate-vigorous physical activity', 'device-based assessment of physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0998878,"For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID).","[{'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Peacock', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Western', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Afroditi', 'Initials': 'A', 'LastName': 'Stathi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Standage', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tapp', 'Affiliation': 'Bristol Business School, University of West of England, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bennett', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK. d.thompson@bath.ac.uk.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00998-5']
1557,32769165,Correction:  Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study .,,2020,,['advanced cervical cancer'],"['anti-angiogenesis therapy', 'chemotherapy with bevacizumab']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0253617,,[],International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000869corr1']
1558,32790595,Variations in loop gain and arousal threshold during NREM sleep are affected by time of day over a 24-hour period in participants with obstructive sleep apnea.,"We investigated whether time of day affects loop gain (LG) and the arousal threshold (AT) during non-rapid eye movement (NREM) sleep. Eleven men with obstructive sleep apnea (apnea-hypopnea index > 5 events/h) completed a constant-routine protocol that comprised 3-h sleep sessions in the evening [10 PM (1) to 1 AM], morning (6 AM to 9 AM), afternoon (2 PM to 5 PM), and subsequent evening [10 PM (2) to 1 AM]. During each sleep session LG and the AT were measured during NREM sleep with a model-based approach. Our results showed the presence of a rhythmicity in both LG ( P  < 0.0001) and the AT ( P  < 0.001) over a 24-h period. In addition, LG and the AT were greater in the morning compared with both evening sessions [6 AM vs. 10 PM (1) vs. 10 PM (2): LG (1 cycle/min): 0.71 ± 0.23 vs. 0.60 ± 0.22 ( P  = 0.01) vs. 0.56 ± 0.10 ( P  < 0.001), AT (fraction of eupneic breathing): 1.45 ± 0.47 vs. 1.28 ± 0.36 ( P  = 0.02) vs. 1.20 ± 0.18 ( P  = 0.001)]. No difference in LG and the AT existed between the evening sessions (LG:  P  = 0.27; AT:  P  = 0.24). LG was correlated to measures of the hypocapnic ventilatory response (i.e., a measure of chemoreflex sensitivity) ( r  = 0.72 and  P  = 0.045) and the critical closing pressure (i.e., a measure of airway collapsibility) ( r  = 0.77 and  P  = 0.02) that we previously published. We conclude that time of day, independent of hallmarks of sleep apnea, affects LG and the AT during NREM sleep. These modifications may contribute to increases in breathing instability in the morning compared with other periods throughout the day/night cycle in individuals with obstructive sleep apnea. In addition, efficaciousness of treatments for obstructive sleep apnea that target LG and the AT may be modified by a rhythmicity in these variables. NEW & NOTEWORTHY  Loop gain and the arousal threshold during non-rapid eye movement (NREM) sleep are greater in the morning compared with the afternoon and evening. Loop gain measures are correlated to chemoreflex sensitivity and the critical closing pressure measured during NREM sleep in the evening, morning, and afternoon. Breathing (in)stability and efficaciousness of treatments for obstructive sleep apnea may be modulated by a circadian rhythmicity in loop gain and the arousal threshold.",2020,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","['participants with obstructive sleep apnea', 'Eleven males with obstructive sleep apnea']",[],"['Loop gain and the arousal threshold', 'breathing instability', 'chemoreflex sensitivity', 'loop gain and the arousal threshold', 'airway collapsibility']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",11.0,0.147017,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","[{'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Puri', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El-Chami', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaheen', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Ivers', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Gino S', 'Initials': 'GS', 'LastName': 'Panza', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Ho-Sheng', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Mateika', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00376.2020']
1559,32777289,"Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.","BACKGROUND


The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS


In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV 1 ) at week 24. Pre and post-dose (30 min) FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients.
RESULTS


Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV 1  (% predicted) 39 ± 16%], 253 completed the study. Mean change in pre-dose FEV 1  from baseline to week 24 increased significantly after administering the triple drug combination [580 ± 600 mL, 95% CI (510, 650 mL), p < 0.0001]. The increase in the pre-dose FEV 1  was significant at all time points (p < 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV 1  and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV 1  both among smokers [mean change 200 ± 430 mL, 95% CI (130, 270 mL), p < 0.0001] as well as non-smokers [990 ± 470 mL, 95% CI (900, 1070 mL), p < 0.0001] at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV 1  and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: -6.6 ± 6.07; smokers: -5.17 + 6.96; non-smokers: 8.06 ± 4.44; all p < 0.0001). The mean difference between the two groups was 2.88 (p < 0.0001) at week 24. TFC was well tolerated.
CONCLUSION


In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.",2020,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"['COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations', 'patients with COPD', 'smoker and non-smoker COPD patients', 'COPD patients requiring triple therapy as judged by their physician, were enrolled', '297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose']","['LABA/LAMA/ICS', 'TFC', 'Tiotropium/Formoterol/Ciclesonide (TFC']","['CAT score', 'tolerated', 'mMRC score', 'FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety', 'lung function, symptoms and quality of life', 'mean change from baseline in pre-dose Forced Expiratory Volume', 'CAT scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",297.0,0.141329,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Salvi', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Sudbhavana Hospital, Varanasi, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Om Surgical Center & Maternity Home, Varanasi, India.'}, {'ForeName': 'Venkateswara Reddy', 'Initials': 'VR', 'LastName': 'Tummuru', 'Affiliation': 'Eesha Multispeciality Hospital, Hyderabad, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kodgule', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Hemalatha', 'Affiliation': 'Sree Narayana Institute of Medical Sciences, Ernakulam, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Awasthi', 'Affiliation': 'Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow, India.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Suraj', 'Affiliation': 'Institute of Chest Diseases, Kozhikode, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Pavitran', 'Affiliation': 'KVM Multispeciality Hospital, Chirtihala, India.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mourya', 'Affiliation': 'Lal Hospital & Heart Centre, Lucknow, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Madonna Hospital and Research Centre, Ernakulam, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}, {'ForeName': 'Sushmeeta', 'Initials': 'S', 'LastName': 'Chhowala', 'Affiliation': 'Cipla Ltd, Mumbai, India. Electronic address: sushmeeta@cipla.com.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Gogtay', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101932']
1560,32773150,When will I feel normal again? Trajectories and predictors of persistent symptoms and poor wellbeing after primary chemotherapy for ovarian cancer.,"OBJECTIVES


After treatment for ovarian cancer, women want to know when they will feel 'normal' again. Our objective was to document the proportions of women with high levels of physical and emotional symptoms at the end of treatment, determine if/when they return to normal and identify groups at risk of persistent symptoms/delayed recovery.
METHODS


Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3 cycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or < 6 weeks after completing chemotherapy (baseline) were included in this analysis (n = 527). PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline. Group-based trajectory models identified clusters of individuals who followed similar patterns. Logistic and Cox regression identified factors associated with persistent symptoms and delayed recovery, respectively.
RESULTS


At baseline, 57% of women reported moderate-to-severe fatigue, 22% anxiety, 20% depression, 14% clinical insomnia and 45% had quality-of-life scores significantly lower than the general population. Between 50 and 75% of individual PRO scores normalised within six months, with the exception of emotional wellbeing (42%), but approximately two-in-five women still had at least one persistently poor PRO at 18 months. Women with more severe symptoms at baseline, who were younger, or had a history of anxiety/depression were more likely to have persistent symptoms or delayed recovery.
CONCLUSIONS


Two-in-five women might never fully return to 'normal' after completing primary treatment for ovarian cancer. Those with risk factors should be triaged for early supportive interventions.",2020,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","['ovarian cancer', 'Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3\u202fcycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or\u202f<\u202f6\u202fweeks after completing chemotherapy (baseline) were included in this analysis (n\u202f=\u202f527']",[],"['emotional wellbeing', 'moderate-to-severe fatigue', 'anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life', 'quality-of-life scores', 'individual PRO scores']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517805', 'cui_str': '527'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.157661,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Webber', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Nagle', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'DeFazio', 'Affiliation': 'The Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia; Department of Gynaecological Oncology, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': ""Queensland Centre for Gynaecological Cancer, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Merran', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'No affiliation. Consumer representative.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.029']
1561,32788268,Early Feeding in Acute Pancreatitis in Children: A Randomized Controlled Trial.,"BACKGROUND


Studies have increasingly challenged the traditional management of acute pancreatitis (AP) with bowel rest. However, these studies used a low-fat diet or transgastric feeding and only included adults. Aiming to generate higher-quality prospective pediatric data, we compared the traditional approach of fasting and intravenous fluids and early enteral feeding with standard diet or formula.
METHODS


Randomized controlled trial of children (2-18 years) with mild-moderate AP. Patients were randomly assigned 1:1 to initial fasting and intravenous fluids or an immediate, unrestricted diet. Pain scores, blood measures, and cross-sectional imaging were recorded throughout admission and follow-up. The primary outcome was time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates.
RESULTS


Of 33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45%) were randomly assigned to initial fasting. We recorded the median (interquartile range [IQR]) time to discharge (2.6 [IQR 2.0 to 4.0] vs 2.9 [IQR 1.8 to 5.6];  P  = .95), reduction in serum lipase levels by day 2 (58% [IQR 2% to 85%] vs 48% [IQR 3% to 71%];  P  = .65), and readmission rates (1 of 18 [6%] vs 2 of 15 [13%];  P  = .22) between the early feeding and fasting cohorts, respectively. Immediate or delayed complication rates did not differ. Patients randomly assigned to early feeding had weight gain of 1.3 kg (IQR 0.29 to 3.6) at follow-up, compared with weight loss of 0.8 kg (IQR -2.1 to 0.7) in fasted patients ( P  = .028).
CONCLUSIONS


This is the first randomized controlled trial in pediatric AP. There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.",2020,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"['Acute Pancreatitis in Children', '33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45', 'children (2-18 years) with mild-moderate AP']","['fasting and intravenous fluids and early enteral feeding with standard diet or formula', 'initial fasting and intravenous fluids or an immediate, unrestricted diet']","['time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates', 'median (interquartile range [IQR]) time to discharge', 'weight gain', 'Immediate or delayed complication rates', 'weight loss', 'readmission rates', 'Pain scores, blood measures, and cross-sectional imaging', 'serum lipase levels']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0428316', 'cui_str': 'Serum lipase measurement'}]",,0.140362,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel; orenl@szmc.org.il.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Duvoisin', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Lekar', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Lopez', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Harveen', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Dehlsen', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Orlanski-Meyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shteyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Krishnan', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Lemberg', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ""Department of Paediatric Gastroenterology, Dana-Dwek Children's Hospital, Tel Aviv, Israel; and.""}, {'ForeName': 'Chee Y', 'Initials': 'CY', 'LastName': 'Ooi', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}]",Pediatrics,['10.1542/peds.2020-1149']
1562,32784257,"Study protocol for the use of photobiomodulation with red or infrared LED on waist circumference reduction: a randomised, double-blind clinical trial.","INTRODUCTION


The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing. In this context, procedures, such as cryolipolysis, ultracavitation, photobiomodulation (PBM) and other techniques have been proposed. Some studies have shown that PBM can be used in body contouring. However, there is no standardisation of the protocol. More than that, as in other techniques for reducing adipose tissue, the availability of triacylglycerol may affect the lipid profile in the blood, bringing consequences to the general health of an individual. This work will aim to compare the light wavelengths when using PBM as a technique for reducing the abdominal waist circumference, while also evaluating the efficacy of the method. Changes in the lipid profile in the blood, with a long-term follow-up, will also be appraised.
METHODS AND ANALYSIS


This will be a controlled, randomised, double-blind, single-centred clinical trial. 174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups: Group A-RED PBM; Group B-INFRARED PBM; Group C-PLACEBO ( Sham ) treatment. The treatments will consist of eight sessions, two times a week, for 4 weeks. At each session, the participants will receive 30 minutes PBM (using a radiant exposure of 127 J/cm 2 ), with an abdominal strap containing 4 LED clusters, with 72 devices each, following the indication of randomisation. All of the groups will receive 30 min of Aussie Current, at 4 kHz, modulated at 10 Hz, 40-60 mA. The main outcome of this study will be waist circumference reduction. The secondary variables will be anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem. The analyses will be performed at four stages of the research, D0, end of the eighth session (D30), 15 days after the last session (FU15), 90 days after the last session (FU90) and 180 days after the last session (FU180).
ETHICS AND DISSEMINATION


The Ethics Committee of the Nove de Julho University, Brazil, approved the modified version of this project under No. 3414146 on 26 June 2019. This study is not yet recruiting. The results obtained will be published in a peer-reviewed journal in the related field.
TRIAL REGISTRATION NUMBER


Brazilian Registry of Clinical Trials-ReBec (RBR-9bwxcx).",2020,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"['174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups']","['photobiomodulation with red or infrared LED', 'Group A-RED PBM', 'PBM']","['abdominal waist circumference', 'anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem', 'waist circumference reduction']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",174.0,0.176906,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Marreira', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Lidiane', 'Initials': 'L', 'LastName': 'Rocha Mota', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Fátima Teixeira', 'Initials': 'DFT', 'LastName': 'Silva', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pavani', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil chrispavani@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-036684']
1563,32784263,'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention.,"INTRODUCTION


A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.
METHODS AND ANALYSIS


We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
ETHICS AND DISSEMINATION


This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03885232.",2020,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","['24 primary care practices in two US states (Washington and Colorado', 'child immunisation status']","['clinician vaccine communication intervention', 'multifaceted clinician vaccine communication strategy', 'Motivational Interviewing (PIVOT with MI']","['clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy', 'immunisation status of children of VHPs']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",24.0,0.0932297,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA douglas.opel@seattlechildrens.org.""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Communication, Portland State University, Portland, Oregon, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Spielvogle', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Spina', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Perreira', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pahud', 'Affiliation': 'Department of Pediatrics, University of Missouri-Kansas City, Kansas City, Missouri, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}]",BMJ open,['10.1136/bmjopen-2020-039299']
1564,32784346,"Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study.","This 7-day randomized, double-blind, placebo-controlled fixed-dose study (NCT03766867) explored the potential for accelerating the onset of antidepressant efficacy of single-dose intravenous (IV) vortioxetine at oral vortioxetine treatment initiation. Patients (ages 18-65 years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 30], received one dose of single-blind IV placebo (1-day placebo lead-in period) before being randomly switched to either single-dose IV vortioxetine 25 mg plus daily oral vortioxetine 10 mg (n = 39), or IV placebo plus daily oral placebo (n = 41). In the placebo lead-in period, patients improved slightly by 0.6 MADRS-6 point; however, at day 1 after randomization, both treatment groups had improved by approximately 3 MADRS-6 points (mean difference = -0.8; P = 0.263), the study thus not meeting its primary endpoint. Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo. Pharmacokinetic data confirmed that IV vortioxetine facilitated reaching steady-state plasma concentration within 24 h. IV plus oral vortioxetine was well tolerated, with low levels of nausea as the most common adverse event.",2020,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"['Patients (ages 18-65\u2009years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a', 'for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score\u2009≥\u200930', 'major depressive disorder']","['vortioxetine 25\u2009mg plus daily oral vortioxetine', 'vortioxetine', 'vortioxetine vs placebo', 'placebo (1-day placebo lead-in period', 'Intravenous vortioxetine', 'selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor', 'placebo plus daily oral placebo', 'single-dose intravenous (IV) vortioxetine', 'placebo']","['nausea', 'anxiety symptoms', 'reaching steady-state plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.68684,Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo.,"[{'ForeName': 'Elmars', 'Initials': 'E', 'LastName': 'Rancans', 'Affiliation': 'Department of Psychiatry and Narcology, Riga Stradins University, Riga, Latvia.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zambori', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Dalsgaard', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Baayen', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Areberg', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ettrup', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Florea', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000326']
1565,32785654,Bone Marrow Metabolism Is Impaired in Insulin Resistance and Improves After Exercise Training.,"CONTEXT


Exercise training improves bone mineral density, but little is known about the effects of training on bone marrow (BM) metabolism. BM insulin sensitivity has been suggested to play an important role in bone health and whole-body insulin sensitivity.
OBJECTIVE


To study the effects of exercise training on BM metabolism.
DESIGN


Randomized controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Sedentary healthy (n = 28, 40-55 years, all males) and insulin resistant (IR) subjects (n = 26, 43-55 years, males/females 16/10).
INTERVENTION


Two weeks of sprint interval training or moderate-intensity continuous training.
MAIN OUTCOME MEASURES


We measured femoral, lumbar, and thoracic BM insulin-stimulated glucose uptake (GU) and fasting free fatty acid uptake (FFAU) using positron-emission tomography and bone turnover markers from plasma.
RESULTS


At baseline, GU was highest in lumbar, followed by thoracic, and lowest in femoral BM (all Ps < 0.0001). FFAU was higher in lumbar and thoracic than femoral BM (both Ps < 0.0001). BM FFAU and femoral BM GU were higher in healthy compared to IR men and in females compared to males (all Ps < 0.05). Training increased femoral BM GU similarly in all groups and decreased lumbar BM FFAU in males (all Ps < 0.05). Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all Ps < 0.05).
CONCLUSIONS


BM metabolism differs regarding anatomical location. Short-term training improves BM GU and FFAU in healthy and IR subjects. Bone turnover rate is decreased in insulin resistance and associates positively with BM metabolism and glycemic control.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01344928.",2020,"Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all p<0.05).
","['Sedentary healthy (n=28, 40-55 years, all males) and insulin resistant subjects (IR) (n=26, 43-55 years, males/females 16/10', 'healthy and IR subjects']","['FFAU', 'exercise training', 'Exercise training', 'femoral BM', 'sprint interval training or moderate-intensity continuous training']","['bone mineral density', 'femoral BM GU', 'Osteocalcin and PINP', 'bone marrow (BM) metabolism', 'lumbar BM FFAU', 'femoral, lumbar and thoracic BM insulin-stimulated glucose uptake (GU) and fasting free fatty acid uptake (FFAU', 'BM FFAU and femoral BM GU', 'Bone turnover rate', 'BM GU and FFAU', 'femoral BM GU and glycemic status']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231544', 'cui_str': 'Bone turnover rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0163126,"Osteocalcin and PINP were lower in IR than healthy men and correlated positively with femoral BM GU and glycemic status (all p<0.05).
","[{'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Ojala', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kumail K', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kaisa K', 'Initials': 'KK', 'LastName': 'Ivaska', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Milja', 'Initials': 'M', 'LastName': 'Arponen', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Mueez', 'Initials': 'M', 'LastName': 'U-Din', 'Affiliation': 'Turku PET Centre, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jarna C', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa516']
1566,32790718,Stepped-care versus treatment as usual in panic disorder: A randomized controlled trial.,"Stepped-care (SC) models for anxiety disorders are implemented on a large scale and are assumed to be as effective for the greater majority of patients as more intensive treatment schemes. To compare the outcomes of SC and international guideline-based treatment (Treatment as Usual: TAU) for panic disorder, a total of 128 patients were randomized to either SC or TAU (ratio 2: 1, respectively) using a computer generated algorithm. They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist. SC comprised 10-week guided self-help (pen-and-paper version) followed, if indicated, by 13-week manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant. TAU consisted of 23-week regular face-to-face CBT (RCBT) with medication -when prescribed- also kept constant. The means of the attended sessions in the SC condition was 5.9 (SD = 4.8) for ITT and 9.6 (SD = 9.6) for the RCBT condition. The difference in the number of attended sessions between the conditions was significant (t(126) = -3.87, p < .001). Remission rates between treatment conditions did not differ significantly (SC: 44.5%; RCBT: 53.3%) and symptom reduction was similar. Stepping up SC treatment to face-to-face CBT showed a minimal additional effect. Importantly, drop-out rates differed significantly for the two conditions (SC: 48.2%; RCBT: 26.7%). SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response. However, SC required significantly less therapist contact time compared to RCBT, and more research is needed to explore predictors of success for guided self-help interventions to allow treatment intensity to be tailored to patients' needs and preferences.",2020,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","['They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist', 'panic disorder, a total of 128 patients']","['manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant', 'SC and international guideline-based treatment (Treatment as Usual: TAU', 'SC', 'SC or TAU']","['therapist contact time', 'remission rate', 'symptom reduction', 'Remission rates', 'number of attended sessions']","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",128.0,0.0572331,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Kampman', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Psychiatry, Amsterdam Public Health Research Institute and GGZ inGeest, Specialized Mental Health Care, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Broekman', 'Affiliation': 'Bureau Bêta, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Verbraak', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237061']
1567,32790725,"Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial.","BACKGROUND


Chronic childhood malnutrition, or stunting, remains a persistent barrier to achieve optimal cognitive development, child growth and ability to reach full potential. Almost half of children under-five years of age are stunted in the province of Sindh, Pakistan.
OBJECTIVE


The primary objective of this study was to test the hypothesis that the provision of lipid-based nutrient supplement-medium-quantity (LNS-MQ) known as Wawamum will result in a 10% reduction in risk of being stunted at the age of 24 months in the intervention group compared with the control group.
DESIGN


A cluster randomized controlled trial was conducted in Thatta and Sujawal districts of Sindh province, Pakistan. A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study. The unit of randomization was union council and considered as a cluster. A total of 12 clusters, 6 in each study group were randomly assigned to intervention and control group. All children received standard government health services, while children in the intervention group also received 50 grams/day of Wawamum.
RESULTS


Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88-0.94, p<0.001) and wasting (RR = 0.78, 95% CI; 0.67-0.92, p = 0.004) as compared to children who received the standard government health services. There was no evidence of a reduction in the risk of underweight (RR = 0.94, 95% CI; 0.85-1.04, p = 0.235) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94-0.99, p = 0.042). The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008). The mean compliance of Wawamum was 60% among children.
CONCLUSIONS


The study confirmed that the provision of Wawamum to children 6-23 months of age is effective in reducing the risk of stunting, wasting and anaemia. This approach should be scaled up among the most food insecure areas/households with a high prevalence of stunting to achieve positive outcomes for nutrition and health. This study was registered at clinicaltrials.gov as NCT02422953. Clinical Trial Registration Number: NCT02422953.",2020,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","['A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study', 'children 6-23 months of age in Sindh, Pakistan', 'Thatta and Sujawal districts of Sindh province, Pakistan']","['standard government health services', 'lipid-based nutrient supplement-medium-quantity (LNS-MQ', 'lipid-based nutrient supplement-Medium quantity']","['reduction of stunting', 'risk of underweight', 'mean compliance of Wawamum', 'risk of stunting', 'reduction of risk of stunting', 'anaemia', 'risk of stunting, wasting and anaemia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",870.0,0.144529,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","[{'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Ali Ahmad', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}]",PloS one,['10.1371/journal.pone.0237210']
1568,32792320,Effect of Short-Term L-Thyroxine Therapy on Left Ventricular Mechanics in Idiopathic Dilated Cardiomyopathy.,"OBJECTIVE


Previous experimental studies have provided evidence of notable changes in thyroid hormone signaling that corresponds to alterations in myocardial function in animal models of heart failure (HF). The present study further explores whether oral thyroid hormone treatment can change left ventricular (LV) mechanics and functional status in patients with idiopathic dilated cardiomyopathy (IDCM) or not.
METHODS


Sixty IDCM patients who were receiving conventional HF treatment were randomized to oral L-thyroxine (n = 40) or placebo (n = 20) for 3 months. Fifty-two (86.7%) of all IDCM patients were symptomatic, their mean age was 41 ± 12 years, and their ejection fraction was 32% ± 7%. At baseline, the two groups were comparable in clinical and echocardiographic variables. Vector velocity imaging was utilized to assess LV mechanics. Myocardial longitudinal peak systolic strain, systolic strain rate, early and late diastolic strain rate, circumferential strain, LV dyssynchrony, plasma tri-iodothyronine, thyroxine, and thyroid stimulating hormone levels were measured at baseline and 3 months after treatment.
RESULTS


All patients receiving L-thyroxine significantly improved in functional status (New York Heart Association class; P < .001) and echocardiographic parameters including end-diastolic diameter (P < .001), end-systolic diameter (P < .001), mitral regurgitation severity reduction (P < .001), and increased ejection fraction (P < .001). Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
CONCLUSIONS


Short-term L-thyroxine therapy is well tolerated in IDCM patients. It improves cardiac mechanics and functional status, which might support the potential role of synthetic thyroid hormones in HF treatment.",2020,"Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
","['Idiopathic Dilated Cardiomyopathy', 'IDCM patients', 'patients with idiopathic dilated cardiomyopathy (IDCM) or not', 'Sixty IDCM patients who were receiving conventional HF treatment']","['oral thyroid hormone treatment', 'L-thyroxine', 'Short-term L-thyroxine therapy', 'oral L-thyroxine', 'Short-Term L-Thyroxine Therapy', 'placebo']","['echocardiographic parameters including end-diastolic diameter', 'Left Ventricular Mechanics', 'end-systolic diameter', 'change left ventricular (LV) mechanics and functional status', 'functional status', 'mitral regurgitation severity reduction', 'Myocardial longitudinal peak systolic strain, systolic strain rate, early and late diastolic strain rate, circumferential strain, LV dyssynchrony, plasma tri-iodothyronine, thyroxine, and thyroid stimulating hormone\xa0levels', 'segmental and global levels of both longitudinal and circumferential myocardial strain', 'cardiac mechanics and functional status', 'ejection fraction']","[{'cui': 'C1449563', 'cui_str': 'Primary idiopathic dilated cardiomyopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C3160953', 'cui_str': 'Left ventricular dyssynchrony'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202237', 'cui_str': 'Tri-iodothyronine measurement, total'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",60.0,0.0255051,"Left ventricular mechanics showed marked improvement at segmental and global levels of both longitudinal and circumferential myocardial strain (P < .005) when compared with placebo group.
","[{'ForeName': 'Hala Mahfouz', 'Initials': 'HM', 'LastName': 'Badran', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt; Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt. Electronic address: halamahfouz_1000@yahoo.com.'}, {'ForeName': 'Naglaa', 'Initials': 'N', 'LastName': 'Faheem', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt; Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Zidan', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt.'}, {'ForeName': 'Magdi H', 'Initials': 'MH', 'LastName': 'Yacoub', 'Affiliation': 'Bibliotheca Alexandrina-Hypertrophic Cardiomyopathy National Program, Alexandria, Egypt; Cardiothoracic Surgery, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Soltan', 'Affiliation': 'Cardiology Department, Menoufia University, Egypt.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.05.009']
1569,32797070,Learning new sport actions: Pilot study to investigate the imitative and the verbal instructive teaching methods in motor education.,"The aim of the project was to investigate the effects of two strategies of teaching new sport actions on performance of eight-year-old children: observational-imitative method (OIM) and descriptive-directive method (DDM). The OIM group was provided with a pre-practice instruction in the form of expert modeling observation by an expert athlete. The DDM group received only verbal explanations of few selected static images. Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment. Subjects were randomly assigned to the OIM or DDM groups. Participants were instructed to perform four sport motor sequences never performed before (shoulder stand, soccer action, vortex howler throw, step action). Actions were videotaped and 2D kinematic analysis performed. A 10-point Likert questionnaire was administered to blind sport experts to assess the correctness and accuracy of each action. Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed. On the contrary, if the athlete needs to learn specific aspects of an exercise (such as grasping a tool) the best method is the DDM. In fact, detailed information on how to grab the vortex helped children in throwing it. We also found gender differences which might reflect cultural influences in specific sports (e.g. soccer). Finally, repetition of the exercise also improved the DDM group's performance. This has potential applications in sport teaching, suggesting that in the absence of a model performing the action to be imitated, the DDM can be as effective as the OIM if the observer repeats the sport action many times.",2020,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"['eight-year-old children', 'Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment']","['teaching new sport actions', 'OIM or DDM']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],36.0,0.0155288,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'De Stefani', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Rodà', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Volta', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pincolini', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Farnese', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rossetti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pedretti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",PloS one,['10.1371/journal.pone.0237697']
1570,32796456,INYBI: A New Tool for Self-Myofascial Release of the Suboccipital Muscles in Patients With Chronic Non-Specific Neck Pain: A Randomized Controlled Trial.,"STUDY DESIGN


A randomized, single-blinded (the outcome assessor was unaware of participants' allocation group) controlled clinical trial.
OBJECTIVE


To investigate the effects of myofascial release therapy (MRT) over the suboccipital muscles, compared with self-MRT using a novel device, the INYBI tool, on pain-related outcomes, active cervical mobility, and vertical mouth opening, in adults with chronic non-specific neck pain (NSNP).
SUMMARY OF BACKGROUND DATA


MRT is used to manage chronic musculoskeletal pain conditions, with purported positive effects. The efficacy of self-MRT, compared with MRT, has been scarcely evaluated.
METHODS


Fifty-eight participants (mean age of 34.6 ± 4.7 yrs; range 21-40 yrs; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n = 29) or a control group (n = 29). Both groups underwent a single 5-minutes intervention session. For participants in the control group, MRT of the suboccipital muscles was performed using the suboccipital muscle inhibition technique, while those in the INYBI group underwent a self-MRT intervention using the INYBI device. Primary measurements were taken of pain intensity (visual analogue scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement. Secondary outcomes included pain-free vertical mouth opening. Outcomes were collected at baseline, immediately after intervention and 45 minutes later.
RESULTS


The analysis of variance (ANOVAs) demonstrated no significant between-groups effect for any variable (all, P > 0.05). In the within-groups comparison, all participants significantly improved pain-related outcomes, and showed similar positive changes for mouth opening. Cervical range-of-movement- mainly increased after intervention for participants in the control group.
CONCLUSION


Both, MRT and self-MRT using the INYBI, are equally effective to enhance self-reported pain intensity, and local pressure pain sensitivity in chronic NSNP patients. For cervical mobility, MRT appears to be slighlty superior, compared with the INYBI, to achieve improvements in this population.
LEVEL OF EVIDENCE


2.",2020,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","['adults with chronic non-specific neck pain (NSNP', 'Patients with Chronic Non-Specific Neck Pain', 'participants in the control group', 'chronic NSNP patients', 'Fifty-eight participants (mean age of 34.6\u200a±\u200a4.7 years; range 21-40 years; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n\u200a=\u200a29) or a control group (n\u200a=\u200a29']","['INYBI', 'self-MRT', 'myofascial release therapy (MRT', 'self-MRT intervention']","['Cervical range-of-movement- mainly', 'pain-free vertical mouth opening', 'pain-related outcomes', 'pain intensity, and local pressure pain sensitivity', 'pain intensity (Visual Analogue Scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement', 'positive changes for mouth opening']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",58.0,0.086756,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pérez-Martínez', 'Affiliation': 'Euska Health Technologies, S.L., Donostia, Spain.'}, {'ForeName': 'Kristobal', 'Initials': 'K', 'LastName': 'Gogorza-Arroitaonandia', 'Affiliation': 'Euska Health Technologies, S.L., Donostia, Spain.'}, {'ForeName': 'Alberto Marcos', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salas-González', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Oliva-Pascual-Vaca', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}]",Spine,['10.1097/BRS.0000000000003605']
1571,32776698,"Progressive task-oriented circuit training for cognition, physical functioning and societal participation in individuals with dementia.","BACKGROUND AND OBJECTIVES


Dementia is commonly associated with cognitive deficit, functional decline and societal participation restriction across multiple domains of functioning. The decline impacts not only on the individual, but also on their informal caregivers, healthcare and the social system. This clinical random controlled study investigated the efficacy of 12-week Progressive Task-oriented circuit training on cognition, physical functioning and societal participation of individuals with dementia.
METHODS


This study involved 31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria. They were randomized into two groups: Progressive Task-oriented circuit training (involved in 12-week circuit training, two times a week for 70 min per session consisting of six workstations) and Control group (training with conventional treatment and home programmes). They were assessed at baseline, mid-intervention and post-intervention using Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test. Data analysed using the independent-samples t tests, paired t tests, Friedman two-way analysis of variance and Mann-Whitney U test (p ≤ .05).
RESULTS


Participants were aged 69.61 ± 3.44 years. There was significant improvement from baseline to post-intervention in cognition (30.77 ± 1.02 vs. 28.77 ± 3.30), physical functioning (28.19 ± 3.90 vs. 25.84 ± 6.26) and societal participation (3.64 ± 0.73 vs. 5.59 ± 2.76). However, the progressive Task-oriented circuit training had more significant improvement than the control group within the group in cognition (p = .000), physical functioning (p = .000), and societal participation (p = .000). There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000). Meanwhile there was statistically significant effect between both groups on cognition, physical functioning and societal participation post-intervention (p < .005).
CONCLUSION


Although both Task-oriented Circuit Training and conventional treatment with home exercise programmes are efficacious, Progressive Task-oriented Circuit Training is more efficacious in enhancing and developing therapeutic strategies to train cognition, improve functional performance and societal participation in the rehabilitation of individuals with dementia.",2020,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","['individuals with dementia', 'Participants were aged 69.61\u2009±\u20093.44\u2009years', '31 individuals living with dementia recruited from a tertiary health institution in Lagos Nigeria']","['Control group (training with conventional treatment and home programmes', 'Progressive Task-oriented circuit training', 'Progressive task-oriented circuit training']","['societal participation', ""Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog), Bristol ADLs, Community integration Questionnaire, 6-min walk test"", 'Physical functioning', 'physical functioning', 'cognition, physical functioning and societal participation post-intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",31.0,0.0161671,"There was no statistical difference within the Control group with cognition (p = .097), Physical functioning (p = 1.000).","[{'ForeName': 'Caleb Ademola Omuwa', 'Initials': 'CAO', 'LastName': 'Gbiri', 'Affiliation': 'Department of Physiotherapy, Stroke and Nervous System Disorders Research Group, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Biliafeez Francisca', 'Initials': 'BF', 'LastName': 'Amusa', 'Affiliation': 'Department of Physiotherapy, Lagos State University Teaching Hospital, Lagos, Nigeria.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1866']
1572,32777383,"Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).","OBJECTIVE


To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
METHOD


This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo at one of seven collaborating sites. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done approximately 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, and week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
RESULTS


This report describes the rationale, design, and methods of the SOARS-B clinical trial.
CONCLUSIONS


There is a tremendous unmet need for safe and effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.",2020,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","['individuals with autism spectrum disorder (ASD', 'children with ASD', '290 participants ages 3 to 17\u202fyears with a DSM-5 diagnosis of ASD']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'open-label oxytocin', 'oxytocin or a matched placebo']","['Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level', 'Reciprocal Social Behaviors (SOARS-B', 'reciprocal social behaviors (SOARS-B', 'social orienting', 'social difficulties']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",290.0,0.0611497,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: marina.spanos@duke.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Seattle Children's Autism Center, Department of Psychiatry and Behavioral Sciences, University of Washington; Seattle, WA, United States of America.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamer', 'Affiliation': 'Departments of Psychiatry and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, UCSF Benioff Children's Hospitals, San Francisco, CA, United States of America.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Lurie Center for Autism, Massachusetts General Hospital; Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': 'Neuroscience Product Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, United States of America; Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Department of Psychiatry, Columbia University; New York State Psychiatric Institute; Center for Autism and the Developing Brain, New York-Presbyterian Hospital, United States of America.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106103']
1573,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1574,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1575,32773594,Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial.,"Pain after total knee arthroplasty is a prevalent condition. This study compared the effectiveness of tapentadol extended-release (ER) 50 mg × 2, oxycodone controlled-release (CR) 10 mg × 2, and placebo, as added to a multimodal analgesic regime both in-hospital and at home the first week after total knee arthroplasty. The study was randomized and blinded for investigators, staff, outcome assessors, and patients. Follow-up included pain intensity on mobilization, pain at rest, worst pain in the previous 24 hours, and adverse effects measured on 0 to 10 numerical rating scales. A total of 134 patients in 3 study groups received their allocated intervention and were included in the analysis. The primary outcome pain on mobilization the 7 first postoperative days reported as area under the curve was 528.1 (SD 267.5, interquartile range (IQR) 356.6-665.4) for placebo, 427.2 (SD 203.9, IQR 303.6-544.3) for tapentadol ER, and 507.9 (SD 243.7, IQR 292.4-686.8) for oxycodone CR (P = 0.12). With the exception of constipation being less prevalent in the tapentadol ER group (P = 0.02), we found no significant differences between treatment groups for the secondary outcomes. Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo. Constipation was lowest in the tapentadol ER group.",2020,Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo.,"['postoperative pain treatment the first 7 days after total knee arthroplasty', 'Pain after total knee arthroplasty (TKA', '134 patients in three study groups received their allocated intervention and were included in the analysis']","['Tapentadol versus oxycodone', 'tapentadol extended release (ER) 50 mg x 2, oxycodone controlled release (CR) 10 mg', 'Tapentadol ER', 'oxycodone CR or placebo', 'tapentadol ER', 'placebo']","['pain on mobilization the 7 first postoperative days reported as mean pain Area Under the Curve (AUC', 'pain intensity on mobilization, pain at rest, worst pain in the previous 24 hours, and adverse effects', 'pain relief', 'Constipation']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",134.0,0.482635,Tapentadol ER as an add-on to multimodal analgesia did not significantly improve pain relief when compared to oxycodone CR or placebo.,"[{'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Rian', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Skogvoll', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hofstad', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Høvik', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Vigdis Schnell', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Tarjei', 'Initials': 'T', 'LastName': 'Egeberg', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Sand', 'Affiliation': 'Department of Health Research, SINTEF Digital, Trondheim, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Klepstad', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Tina Strømdal', 'Initials': 'TS', 'LastName': 'Wik', 'Affiliation': 'Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}]",Pain,['10.1097/j.pain.0000000000002026']
1576,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1577,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1578,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1579,32780643,"Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated  EGFR -mutated metastatic non-small-cell lung cancer.","OBJECTIVE


In the phase 3 RELAY trial, ramucirumab/erlotinib demonstrated superior progression-free survival (PFS) over placebo/erlotinib in patients with  EGFR -mutated metastatic NSCLC (median PFS 19.4 versus 12.4 months; HR = 0.59, 95% CI = 0.46-0.76;  p  < .0001). Safety was consistent with established profiles for ramucirumab and erlotinib in NSCLC. Here, we present patient-reported outcomes.
METHODS


Patients received oral erlotinib (150 mg daily) plus intravenous ramucirumab (10 mg/kg) or placebo Q2W until progressive disease or unacceptable toxicity. Patients completed the Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires at baseline and every other cycle. Analyses included time to deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models and changes from baseline using mixed-model repeated-measures regression analysis.
RESULTS


Overall patient compliance for LCSS and EQ-5D was >95%. TtD did not differ between treatment arms for LCSS Total Score (HR = 0.962, 95% CI = 0.690-1.343) and Average Symptom Burden Index (HR = 1.012, 95% CI = 0.732-1.400). TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality of life) indicated no difference between arms; however, patient-reported blood in sputum was worse for ramucirumab/erlotinib (HR = 1.987, 95% CI = 1.206-3.275). Results of LCSS mean changes from baseline were consistent with TtD, indicating no significant differences between treatment arms except for blood in sputum. Mean changes from baseline in EQ-5D index score ( p  = .94) and visual analogue scale ( p  = .95) revealed no overall differences in health status between treatment arms.
CONCLUSIONS


Patients' overall quality of life and symptom burden did not differ with the addition of ramucirumab to erlotinib compared to placebo/erlotinib. These data support the clinical benefit of ramucirumab/erlotinib in untreated  EGFR -mutated metastatic NSCLC.",2020,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,[],"['placebo/erlotinib', 'ramucirumab/erlotinib', 'placebo Q2W', 'oral erlotinib (150\u2009mg daily) plus intravenous ramucirumab', 'placebo plus erlotinib']","['overall quality-of-life and symptom burden', 'superior progression-free survival (PFS', 'Overall patient compliance for LCSS and EQ-5D', 'LCSS Total Score', 'visual analogue scale', 'TtD of individual LCSS items (appetite loss, fatigue, cough, shortness of breath, pain, symptom distress, difficulties with daily activities, quality-of-life', 'blood-in-sputum', 'health status', 'Lung Cancer Symptom Scale (LCSS) and EQ-5D questionnaires', 'time-to-deterioration (TtD) for LCSS via Kaplan-Meier method and Cox models', 'Average Symptom Burden Index', 'EQ-5D index score', 'LCSS mean changes']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.423814,Mean changes from baseline in EQ-5D index score (p = 0.94) and visual analogue scale (p = 0.95) revealed no overall differences in health status between treatment arms.,"[{'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lungen Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles/TRIO-US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce Aix', 'Affiliation': 'Hospital Universitario, CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Winfree', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Lilly Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current medical research and opinion,['10.1080/03007995.2020.1808781']
1580,32788190,Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,"INTRODUCTION


Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.
METHODS AND ANALYSIS


The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.
ETHICS AND DISSEMINATION


The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l'Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.
TRIAL REGISTRATION NUMBER


NCT01824537.",2020,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","['heterosexual couples living in Montreal, Canada', 'sexual partners of vaccinated individuals', 'heterosexual couples', 'Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible']","['HPV vaccination (TRAP-HPV', 'intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo', 'HPV vaccination', 'HPV vaccine']",['transmission of genital and oral HPV infection'],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C3864947', 'cui_str': 'Gardasil 9'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}]",,0.257928,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'MacCosham', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ann N', 'Initials': 'AN', 'LastName': 'Burchell', 'Affiliation': ""Department of Family and Community Medicine and Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ""Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de Médecine de Laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada eduardo.franco@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039383']
1581,32784252,Factors promoting physical activity in women with fibromyalgia: a qualitative interview study.,"OBJECTIVES


To gain deeper knowledge of factors promoting physical activity in women with fibromyalgia.
DESIGN


A qualitative study based on semistructured in-depth individual interviews. Analysed using qualitative content analysis.
PARTICIPANTS


Fourteen women with fibromyalgia, age 38-65, recruited from a previous randomised controlled trial investigating the effects of person-centred progressive resistance exercise compared with relaxation therapy.
SETTING


Interviews were conducted in a hospital setting.
RESULTS


The analysis resulted in four categories:  a desire to be physically active, finding the proper level and creating proper conditions, managing pain  and  getting it done .
CONCLUSION


This study reveals several factors both personal and environmental, which promote the ability to be physically active when living with pain and other symptoms of fibromyalgia. The participants expressed that, although they had a desire to be physically active, they needed support and guidance from a professional with adequate knowledge to help them find the proper level of exercise. They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.",2020,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","['women with fibromyalgia', 'Fourteen women with fibromyalgia, age 38-65', 'Interviews were conducted in a hospital setting']",['person-centred progressive resistance exercise compared with relaxation therapy'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]",[],14.0,0.135076,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden anette.e.larsson@vgregion.se.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Feldthusen', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Mannerkorpi', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031693']
1582,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
1583,32799365,Randomized clinical trial comparing PEG-based synthetic to porcine-derived collagen membrane in the preservation of alveolar bone following tooth extraction in anterior maxilla.,"OBJECTIVES


The objective of this randomized controlled trial was to compare alveolar ridge preservation using a bone substitute material and covered with a synthetic or porcine collagen membrane.
MATERIALS AND METHODS


Thirty-two sockets in the aesthetic maxillary region of 30 patients were randomized into two groups. Randomization was stratified according to bone wall defect. Flapless technique was used, and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic polyethylene glycol (PEG; test group) or porcine-derived collagen membrane (CM; control group). No primary closure was attempted. A cone beam computed tomography (CBCT) scan was performed immediately after the surgical procedure and repeated 22 weeks later. OnDemand3D was used to superimpose scan images and assess changes. The mean vertical and horizontal percentage bone loss were calculated and implants placed after 6 months with or without additional augmentation.
RESULTS


There were no baseline differences between groups or dropouts. The mean percentage loss at the labial plate and at the coronal part of the sockets was statistically significantly lower in the test group compared with controls (-2.86% [SD = 13.48] versus 7.42% [SD = 11.95]; 13.45% [SD = 11.97] versus 28.59% [SD = 16.97]). Implants were placed after 6 months, and there was no difference in need for further augmentation between PEG (n = 5) or CM (n = 4).
CONCLUSION


Sites treated with PEG membrane showed less percentage loss in horizontal and vertical measurements in this trial.",2020,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","['anterior maxilla', 'Thirty-two sockets in the esthetic maxillary region of 30 patients']","['cone beam computed tomography (CBCT) scan', 'peg-based synthetic to porcine-derived collagen membrane', 'bone substitute material and covered with a synthetic or porcine collagen membrane', 'Flapless technique was used and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic poly-ethylene glycol (PEG; test group) or porcine derived collagen membrane (CM; control group', 'PEG membrane']","['mean percentage loss', 'mean vertical and horizontal percentage bone loss']","[{'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0015083', 'cui_str': 'ethylene glycol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0841553,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","[{'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Shahdad', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital, London, UK.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Gamble', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital, London, UK.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Matani', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gambôa', 'Affiliation': 'University of Bristol, School of Oral and Dental Sciences, Bristol, UK.'}]",Clinical oral implants research,['10.1111/clr.13648']
1584,32773670,Plasma resuscitation with adjunctive peritoneal resuscitation reduces ischemic intestinal injury following hemorrhagic shock.,"INTRODUCTION


Impaired intestinal microvascular perfusion following resuscitated hemorrhagic shock (HS) leads to ischemia-reperfusion injury, microvascular dysfunction, and intestinal epithelial injury, which contribute to the development of multiple organ dysfunction syndrome in some trauma patients. Restoration of central hemodynamics with traditional methods alone often fails to fully restore microvascular perfusion and does not protect against ischemia-reperfusion injury. We hypothesized that resuscitation (RES) with fresh frozen plasma (FFP) alone or combined with direct peritoneal resuscitation (DPR) with 2.5% Delflex solution might improve blood flow and decrease intestinal injury compared with conventional RES or RES with DPR alone.
METHODS


Sprague-Dawley rats underwent HS (40% mean arterial pressure) for 60 minutes and were randomly assigned to a RES group (n = 8): sham, HS-crystalloid resuscitation (CR) (shed blood + two volumes CR), HS-CR-DPR (intraperitoneal 2.5% peritoneal dialysis fluid), HS-FFP (shed blood + two volumes FFP), and HS-DPR-FFP (intraperitoneal dialysis fluid + two volumes FFP). Laser Doppler flowmeter evaluation of the ileum, serum samples for fatty acid binding protein enzyme-linked immunosorbent assay, and hematoxylin and eosin (H&E) staining were used to assess intestinal injury and blood flow. p Values of <0.05 were considered significant.
RESULTS


Following HS, the addition of DPR to either RES modality improved intestinal blood flow. Four hours after resuscitated HS, FABP-2 (intestinal) and FABP-6 (ileal) were elevated in the CR group but reduced in the FFP and DPR groups. The H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significantly in the CR group. Combination therapy with FFP and DPR demonstrated negligible cellular injury in H&E graded samples and a significant reduction in fatty acid binding protein levels.
CONCLUSION


Hemorrhagic shock leads to ischemic-reperfusion injury of the intestine, and both FFP and DPR alone attenuated intestinal damage; combination FFP-DPR therapy alleviated most signs of organ injury. Resuscitation with FFP-DPR to restore intestinal blood flow following shock could be an essential method of reducing morbidity and mortality after trauma.",2020,"H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significant in the CR group.",['Sprague Dawley rats underwent HS (40% mean arterial pressure) for 60 minutes and were randomly assigned to a resuscitation group (n=8'],"['resuscitation with fresh frozen plasma (FFP) alone or combined with direct peritoneal resuscitation (DPR) with 2.5%Delflex solution', 'resuscitated hemorrhagic shock (HS/RES', 'Sham; HS+crystalloid resuscitation(CR) (shed blood+two volumes CR); HS+CR+DPR (intraperitoneal 2.5% peritoneal dialysis fluid (IP)); HS+FFP (shed blood+two volumes FFP); HS+DPR+FFP (IP dialysis fluid+two volumes FFP', 'FFP+DPR']","['intestinal villi', 'intestinal blood flow', 'intestinal injury and blood flow', 'blood flow and decrease intestinal injury', 'FABP levels']","[{'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0353714', 'cui_str': 'Peritoneal dialysis solution'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}]","[{'cui': 'C0227266', 'cui_str': 'Intestinal villus'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.079668,"H&E staining demonstrated disrupted intestinal villi in the FFP and CR groups, most significant in the CR group.","[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Schucht', 'Affiliation': 'From the Robley Rex Veterans Affairs Medical Center (J.E.S., P.J.M.); Departments of Surgery (J.E.S., P.J.M., B.G.H., L.B., S.J., J.W.S.), Physiology and Biophysics (J.E.S., P.J.M., J.W.S.), and Pathology (K.J.M.A.), University of Louisville, Louisville; and Eastern Kentucky University (G.R.A.), Richmond, Kentucky.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Matheson', 'Affiliation': ''}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': ''}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Khaled J M', 'Initials': 'KJM', 'LastName': 'Alkhateeb', 'Affiliation': ''}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Ashkettle', 'Affiliation': ''}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002847']
1585,32785213,Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.,"In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 , a pandemic. With rapidly accumulating numbers of cases and deaths reported globally 2 , a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.",2020,RBD-binding IgG concentrations and SARS-CoV-2,"['45 healthy adults, 18 to 55 years of age', 'adults']","['COVID-19 RNA vaccine BNT162b1', 'lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD']","['Geometric mean neutralizing titers', 'Local reactions and systemic events', 'RBD-binding IgG concentrations and SARS-CoV-2', 'reactogenicity', 'neutralizing titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",45.0,0.183612,RBD-binding IgG concentrations and SARS-CoV-2,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}]",Nature,['10.1038/s41586-020-2639-4']
1586,32785495,High-intensity Interval Training versus Continuous Exercise: Is There a Difference Regarding the Magnitude of Blood Pressure Reduction?,,2020,,[],['High-intensity Interval Training versus Continuous Exercise'],[],[],"[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0286429,,"[{'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Programa de Pós-Graduação em Cardiologia e Ciências Cardiovasculares, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Vítor Magnus', 'Initials': 'VM', 'LastName': 'Martins', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20200261']
1587,32790783,Observed feeding behaviours and effects on child weight and length at 12 months of age: Findings from the SPRING cluster-randomized controlled trial in rural India.,"BACKGROUND


Child undernutrition results in poor growth in early childhood, undermines optimal development and increases the risk of mortality. Responsive feeding has been promoted as a key intervention for improving nutritional status, however measurement of this remains difficult and has rarely considered child behaviour. We therefore developed a new observed feeding tool to assess both child and caregiver behaviours, as well as their interaction during feeding, and investigate the effect of these on children anthropometric measures at 12-months of age in rural India.
METHODS


Our study was nested within the SPRING cluster-randomized controlled trial in Rewari, North India. Outcomes were children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores at 12 months of age, based on the WHO Child Growth standards. Trained non-specialists live-coded feeding episodes using the newly designed tool. Scores were then created using principal components analysis representing child behaviour, caregiver behaviour and caregiver-child interaction. Mixed effects linear regression was used to assess associations between feeding behaviours and anthropometric outcomes.
RESULTS


857 children had a meal observation and were included. Anthropometric status was poor (mean length-for-age -1.59 (SD = 1.11); mean weight-for-length -0.58 (0.95); mean weight-for-age -1.22 (1.04)). There were positive linear differences in weight-for-length per unit increase in caregiver responsive behaviours score (adjusted β-coeff = 0.006, 95%CI = (0.001, 0.011), p = 0.01), in length-for-age and weight-for-age per unit increase in child responsive behaviours score (respectively adjusted β-coeff = 0.004, 95%CI = (0.001, 0.007), p = 0.02, and adjusted β-coeff = 0.003, 95%CI = (0.00001, 0.006), p = 0.049), and in both weight-for-length and weight-for-age per unit increase in caregiver-child interaction score (respectively adjusted β-coeff = 0.007, 95%CI = (0.003, 0.012), p = 0.001, and adjusted β-coeff = 0.005, 95%CI = (0.001, 0.011), p = 0.01). No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
CONCLUSIONS


We found that trained non-specialists could assess feeding episodes using a newly designed checklist. Further, child and caregiver behaviours were associated with weight and length at only 12 months of age, a reminder of the importance of interventions to improve responsive feeding quality as we strive towards achievement of the sustainable development goals.",2020,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
",['857 children had a meal observation and were included'],[],"['children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores', 'mean weight', 'Anthropometric status', 'child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length', 'child responsive behaviours score', 'weight-for-length per unit increase in caregiver responsive behaviours score', 'child weight and length', 'weight-for-length and weight-for-age per unit increase in caregiver-child interaction score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1321223', 'cui_str': 'Caregiver behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",857.0,0.11637,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Boucheron', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhopal', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Verma', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Reetabrata', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0237226']
1588,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1589,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
1590,32800842,Treating Home Versus Predialysis Blood Pressure Among In-Center Hemodialysis Patients: A Pilot Randomized Trial.,"RATIONALE AND OBJECTIVE


Observational studies have reported a U-shaped association between pre-dialysis blood pressure (BP) and death. In contrast, a linear association between out-of-dialysis unit BP has been reported. Home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home vs. pre-dialysis BP in hemodialysis patients.
STUDY DESIGN


A 4-month parallel, randomized controlled trial.
SETTINGS & PARTICIPANTS


Fifty prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomized using 1:1 block randomization, stratified by site.
INTERVENTIONS


Target home systolic BP (SBP) vs. pre-dialysis SBP 140-100 mmHg. Home and pre-dialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.
OUTCOMES


Primary outcomes were feasibility, adherence, safety and tolerability.
RESULTS


Fifty out of seventy patients who were approached agreed to participate (71.4%). All enrollees completed the study except one who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs. 16%).
LIMITATIONS


Small sample size.
CONCLUSIONS


This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test long-term feasibility, efficacy and safety of home BP treatment in hemodialysis patients should be conducted.",2020,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","['All enrollees completed the study except one who received a kidney transplant', 'Fifty out of seventy patients who were approached agreed to participate (71.4', 'Center Hemodialysis Patients', 'Fifty prevalent hemodialysis patients in San Francisco and Seattle', 'hemodialysis patients']","['Target home systolic BP (SBP', 'Treating Home Versus Predialysis Blood Pressure', 'treating home vs. pre-dialysis BP']","['pre-dialysis BP readings', 'Dry weight and BP medications', 'frequency of fatigue', 'frequency of high', 'adherence to obtaining/reporting home BP', 'feasibility, adherence, safety and tolerability']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.0430896,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington. Electronic address: nbansal@nephrology.washington.edu.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Division of Nephrology, University of Pennsylvania.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Division of Nephrology, University of Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Linke', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Palad', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Larson', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.06.014']
1591,32805748,The Truview PCD™ video laryngoscope for nasotracheal intubation in pediatric patients: A subset analysis from a prospective randomized controlled trial.,,2020,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).",['Pediatric Patients'],"['Video laryngoscopy', 'FDA-approved video laryngoscope', 'Truview PCD™ Video Laryngoscope']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",[],,0.0696842,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).","[{'ForeName': 'Proshad Nemati', 'Initials': 'PN', 'LastName': 'Efune', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saynhalath', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'James-Michael', 'Initials': 'JM', 'LastName': 'Blackwell', 'Affiliation': 'Department of Population and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Steiner', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Olomu', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szmuk', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}]",Paediatric anaesthesia,['10.1111/pan.14005']
1592,32778009,Efficacy of psychotherapy for anxiety reduction in hospital management of women successfully treated for preterm labor: a randomized controlled trial.,"Preterm labor (PTL) is associated with high anxiety and stress in pregnant women. The study investigated the effect of adding psychotherapy to hospital management of pregnant women with successfully treated for PTLon improving anxiety, pregnancy stress, and perceived control. In a randomized controlled trial study, sixty pregnant women with gestational ages of 24 to 37 weeks and successfully treated forPTL were randomly divided into the experimental (n = 30) and control group (n = 30). The experimental group received psychotherapy along with medical care in individual face-to-facesessions, 1 h per day for 6 consecutive days.The control group received medical care for PTL. Objective outcomes were assessed via the State-Anxiety Inventory, Prenatal Distress Questionnaire (NuPDQ), and Perceived Pregnancy Control at pre-trial and post-trial. The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention. The findings suggest that adding psychotherapy to hospital management of women successfully treated for PTLcan be considered a potential method to reduce anxiety and pregnancy-specific stress.",2020,"The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention.","['pregnant women with successfully treated for PTLon improving anxiety, pregnancy stress, and perceived control', 'sixty pregnant women with gestational ages of 24 to 37\xa0weeks and successfully treated forPTL', 'hospital management of women successfully treated for preterm labor', 'pregnant women']","['psychotherapy', 'Preterm labor (PTL', 'medical care for PTL']","['mean pregnancy distress', 'State-Anxiety Inventory, Prenatal Distress Questionnaire (NuPDQ), and Perceived Pregnancy Control', 'state anxiety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.125459,"The results revealed that psychotherapy significantly improved mean pregnancy distress (45.80 ± 2.29 vs. 43.80 ± 1.93), state anxiety (47.46 ± 5.92 vs. 41.60 ± 5.46), and perceived control (2.86 ± 1.59 vs. 5.26 ± 1.38) in women with PTL from beginning to end of the intervention.","[{'ForeName': 'Seyyedeh Mahboubeh', 'Initials': 'SM', 'LastName': 'Mirtabar', 'Affiliation': 'Department of Psychology, Islamic Azad University, Ayatollah Amoli Science and Research Branch, Amol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences , Babol, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Khazaei', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Dini', 'Affiliation': 'Clinical Research Development Unit of Rohani Hospital, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Women & health,['10.1080/03630242.2020.1803464']
1593,32781457,Addition of Fentanyl or High-Dose Morphine to Bupivacaine Is Superior to Bupivacaine Alone during Single-Shot Spinal Anesthesia.,"BACKGROUND


Single-shot spinal anesthesia (SSSA) with bupivacaine is a useful technique for pain control during the active phase of labor due to its simplicity and rapid onset. In this study, we evaluated the efficacy of the addition of fentanyl or high-dose morphine to bupivacaine during SSSA.
METHODS


Ninety healthy consecutive multiparous parturients in the active phase of progressing labor (cervical dilatation ≥7 cm; pain score >4) requesting analgesia were included in this study. The patients were randomly allocated into 3 SSSA groups as follows: group 1 (n = 30) receiving 2.5-mg hypobaric bupivacaine alone, group 2 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 10-μg fentanyl, and group 3 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 0.5-mg morphine. The duration of analgesia, VAS scores, side effects, and obstetric and neonatal outcomes were compared.
RESULTS


The main gestational age and cervical dilatation of the patients were 38.7 ± 1.5 months and 7.2 ± 2.2 cm (p = 0.14 and p = 0.65), respectively. The main VAS score significantly decreased in all groups at 3 h from baseline: from 8.25 to 1.75 in group 1, from 7.61 to 1.28 in group 2, and from 8.12 to 1.26 in group 3 (p < 0.001). The duration of the second phase of delivery was similar in all groups (45.5, 44, and 38 min, respectively; p = 0.67). The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01). The Apgar scores and fetal heart rates were similar in all groups (p = 0.95). Side effects were similar, except for pruritus in group 3 (p = 0.01).
CONCLUSION


The addition of fentanyl or high-dose morphine to bupivacaine increases the efficacy and duration of SSSA in the active phase of progressing labor without increasing side effects.",2020,"The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01).",['Ninety healthy consecutive multiparous parturients in the active phase of progressing labor (cervical dilatation ≥7 cm; pain score >4) requesting analgesia were included in this study'],"['Fentanyl or High-Dose Morphine', 'Bupivacaine', 'bupivacaine', 'SSSA', 'fentanyl or high-dose morphine', '2.5-mg hypobaric bupivacaine alone, group 2 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 10-μg fentanyl, and group 3 (n = 30) receiving a combination of 2.5-mg hypobaric bupivacaine and 0.5-mg morphine']","['duration of the second phase of delivery', 'total analgesia duration', 'duration of analgesia, VAS scores, side effects, and obstetric and neonatal outcomes', 'efficacy and duration of SSSA', 'main VAS score', 'Side effects', 'Apgar scores and fetal heart rates']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}]",90.0,0.0811958,"The total analgesia duration was significantly higher in group 3 (172, 180, and 190 min for groups 1, 2, and 3, respectively; p = 0.01).","[{'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Aslan', 'Affiliation': 'Department of Anesthesia and Reanimation, Zekai Tahir Burak Training and Research Hospital, University of Health Sciences, Ankara, Turkey, drbilgeaslan@hotmail.com.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Moraloğlu', 'Affiliation': 'Department of Obstetrics, Zekai Tahir Burak Training and Research Hospital, University of Health Sciences, Ankara, Turkey.'}]",Gynecologic and obstetric investigation,['10.1159/000509513']
1594,32780926,Effects of intraoperative dexmedetomidine on the incidence of acute kidney injury in pediatric cardiac surgery patients: A randomized controlled trial.,"BACKGROUND


Perioperative dexmedetomidine use has been reported to reduce the incidence of postoperative acute kidney injury after adult cardiac surgery. However, large-scale randomized controlled trials evaluating the effect of dexmedetomidine use on acute kidney injury in pediatric patients are lacking.
AIMS


We investigated whether intraoperative dexmedetomidine could reduce the incidence of acute kidney injury in pediatric cardiac surgery patients.
METHODS


In total, 141 pediatric patients were randomly assigned to dexmedetomidine or control groups. After anesthetic induction, patients in the dexmedetomidine group were administered 1 µg/kg of dexmedetomidine over 10 minutes and an additional 0.5 µg/kg/h of dexmedetomidine during surgery. Additionally, 1 µg/kg of dexmedetomidine was infused immediately after cardiopulmonary bypass was initiated. The incidence of acute kidney injury was defined following Kidney Disease Improving Global Outcomes guidelines.
RESULTS


The final analysis included 139 patients. The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; P = .33). Similarly, neither the incidence of abnormal postoperative estimated glomerular filtration rate values (P = .96) nor the incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit, and hospitalization differed between the two groups.
CONCLUSIONS


Intraoperative dexmedetomidine did not reduce acute kidney injury incidence in pediatric cardiac surgery patients.",2020,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"['141 pediatric patients', 'pediatric patients', 'pediatric cardiac surgery patients', 'acute kidney injuryin pediatric cardiac surgery patients', '139 patients']","['intraoperativedexmedetomidine', 'dexmedetomidine', 'intraoperative dexmedetomidine']","['acute kidney injuryincidence', 'incidence of abnormal postoperative estimated glomerular filtration ratevalues', 'northe incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit,and hospitalization', 'incidence of acute kidney injury']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",141.0,0.5822,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"[{'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woong-Han', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiothoracic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Gun', 'Initials': 'JG', 'LastName': 'Kwak', 'Affiliation': 'Department of Cardiothoracic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Paediatric anaesthesia,['10.1111/pan.13995']
1595,32791295,Assessment of safety and efficacy of antimicrobial photodynamic therapy for peri-implant disease.,"BACKGROUND


There is no reliable treatment procedure for peri-implant disease, despite the rise in its incidence. This study sought to evaluate the short-term safety and efficacy of antimicrobial photodynamic therapy (a-PDT) on peri-implantitis by assessing the volume of pus discharge after a-PDT.
METHODS


Patients with pus discharge from a peri-implant pocket were recruited from December 1st, 2019 to April 30th, 2020. The enrolled implants were randomly assigned to one of two groups, the irrigation and a-PDT groups. Their peri-implant pocket was irrigated with normal saline in the irrigation group, and a saline irrigation and subsequent a-PDT with toluidine blue (TB) was performed in the a-PDT group. The safety and efficacy of a-PDT were assessed 7 days after treatment.
RESULTS


Twenty-five implants in 21 patients (irrigation group; 13 implants, a-PDT group; 12 implants) were registered. No complication was observed after a-PDT. Pus discharge was decreased in 7 of 12 implants (58.3 %) in the a-PDT group, and in 2 of 13 implants (15.4 %) in the irrigation group. According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
CONCLUSIONS


a-PDT was confirmed to be a safe treatment for peri-implantitis, and the short-term efficacy of a-PDT with TB on peri-implantitis was clarified. Nevertheless, its efficacy remains restricted, and a new combination therapy of a-PDT and decontamination procedures is expected to be developed in future.",2020,"According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
","['peri-implant disease', 'Patients with pus discharge from a peri-implant pocket were recruited from December 1 st , 2019 to April 30 th , 2020']","['antimicrobial photodynamic therapy', 'antimicrobial photodynamic therapy (a-PDT', 'saline irrigation and subsequent a-PDT with toluidine blue (TB']","['No complication', 'safety and efficacy', 'pus discharge', 'Pus discharge']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0496946,"According to Fisher's exact test, a-PDT resulted in a statistically significant decrease in pus discharge compared to irrigation alone (p = 0.0414).
","[{'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Ohba', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan. Electronic address: sohba@nagasaki-u.ac.jp.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Dental Hygiene, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Noda', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Egahira', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Asahina', 'Affiliation': 'Department of Regenerative Oral Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan; Center for Oral and Maxillofacial Implants, Nagasaki University Hospital, Japan.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101936']
1596,32792425,"Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol.","INTRODUCTION


Fever is one of the most common reasons for consultation in the paediatric emergency department (ED). Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment. The aims of this study are to demonstrate that using a procalcitonin (PCT) rapid test-based prediction rule (1) would not be inferior to usual practice in terms of morbidity and mortality (non-inferiority objective) and (2) would result in a significant reduction in antibiotic use (superiority objective).
METHODS AND ANALYSIS


This prospective multicentric cluster-randomised study aims to include 7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period. During first period, all children will receive usual care. In a second period, a point-of-care PCT-based algorithm will be used in half of the clusters. The primary endpoints collected on day 15 after ED consultation will be a composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment administered for the superiority objective. The endpoints will be compared between the two groups (experimental and control) by using a mixed logistic regression model adjusted on clustering of participants within centres and period within centres.
DISCUSSION


If the algorithm is validated, a new strategy will be discussed with medical societies to safely manage fever in young children without the need for invasive procedures for microbiological testing or empirical antibiotics.
ETHICS AND DISSEMINATION


This study was submitted to an independent ethics committee on 17 May 2018 (no. 2018-A00252-53). Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER


NCT03607162; Pre-results.",2020,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","['young febrile children in the emergency department (DIAFEVERCHILD', '7245 febrile children aged 6 days to 3 years with a diagnosis of fever without source in 26 participating EDs in France and Switzerland during a 24-month period', 'young children', 'independent ethics committee on 17 May 2018 (no. 2018-A00252-53']",[],"['composite outcome of death or intensive care unit admission for any reason, disease-specific complications, diagnosis of bacterial infection after discharge from the ED for the non-inferiority objective and proportion of children with antibiotic treatment']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",7245.0,0.218545,"Because of fear of bacterial infection in parents and caregivers, clinicians often overprescribe laboratory tests and empirical antibiotic treatment.","[{'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Hubert', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France gaelle.hubert@chu-nantes.fr.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Launay', 'Affiliation': 'General Paediatrics Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Feildel Fournial', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chauvire-Drouard', 'Affiliation': 'Clinical Research Department, Clinical Investigation Center Femme Enfant Adolescent-1413 INSERM, CHU Nantes, Nantes, France.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Lorton', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Biostatistics Department, Clinical Investigation Center-1415 INSERM, CHU Tours, Tours, France.'}, {'ForeName': 'Christele', 'Initials': 'C', 'LastName': 'Gras Le Guen', 'Affiliation': 'Paediatrics Emergency Department, CHU Nantes, Nantes, France.'}]",BMJ open,['10.1136/bmjopen-2019-034828']
1597,32792427,Microwave ablation versus radiofrequency ablation for the treatment of severe complicated monochorionic pregnancies in China：protocol for a pilot randomised controlled trial.,"INTRODUCTION


Complicated monochorionic twin pregnancies are often associated with high perinatal morbidity and mortality, some of which are severe enough to require a gestational reduction surgery to improve fetal survival and reduce disabilities. While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions. Currently there is limited evidence to prove the feasibility of MWA for selective reduction. The aim of this pilot study is to explore the feasibility, efficacy and safety of MWA reduction for severe complicated monochorionic pregnancies and may provide evidence for using the MWA in intrauterine surgeries extensively.
METHODS AND ANALYSIS


This is a study protocol for a parallel-design pilot randomised controlled trial. 60 eligible patients with severe complicated monochorionic pregnancies will be randomised in a ratio of 1:1 to MWA group and radiofrequency group. Patients will be followed up until 6 months of age of the retained fetal. The primary analysis will compare the rates of neonatal survival at 28 days to evaluate the effect of MWA. The study will also evaluate the safety profile of MWA including the occurrence of postoperative adverse events and maternal and fetal complications. Additional secondary outcomes to be explored include the condition of neonatal asphyxia and the growth of surviving fetus at 6 months. Outcomes will be analysed by both a frequentist and the Bayesian statistical approach.
ETHICS AND DISSEMINATION


This study was approved by the ethical review committee of the Peking University Third Hospital (Beijing, China). The results of this study will be published in peer-reviewed scientific journals and presented at relevant academic conferences.
TRIAL REGISTRATION NUMBER


NCT04014452; Pre-results.",2020,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","['Peking University Third Hospital (Beijing, China', '60 eligible patients with severe complicated monochorionic pregnancies', 'severe complicated monochorionic pregnancies']","['Microwave ablation versus radiofrequency ablation', 'radiofrequency ablation', 'MWA', 'MWA group and radiofrequency group']","['condition of neonatal asphyxia and the growth of surviving fetus at 6 months', 'rates of neonatal survival']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",60.0,0.194793,"While radiofrequency ablation is currently the most commonly used procedure with higher fetal survival and fewer maternal and fetal complications compared with other surgical methods, the therapeutic effect of microwave ablation (MWA) is reported to be better, presumably due to the higher thermal effect and fewer restrictions.","[{'ForeName': 'Jialei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing, China xlwang@bjmu.edu.cn weiyuanbysy@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034995']
1598,32792431,Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial.,"INTRODUCTION


Preserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.
METHODS AND ANALYSIS


After screening to ensure native renal urea clearance >3 mL/min/1.73 m 2 , the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.
TRIAL REGISTRATION NUMBER


NCT03418181.",2020,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","['incident HD patients', 'four UK renal centres']","['RKF', 'incremental versus conventional initiation of haemodialysis']","['impact of dialysis intensity on vascular access events, major adverse cardiac events and survival', 'feasibility of conducting a definitive RCT', 'hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events', 'EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score', 'residual kidney function', 'rate of decline of RKF']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",54.0,0.192481,"Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.","[{'ForeName': 'Raja Mohammed', 'Initials': 'RM', 'LastName': 'Kaja Kamal', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Farrington', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wellsted', 'Affiliation': 'School of Life Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Sridharan', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Alchi', 'Affiliation': 'Renal Unit, Royal Berkshire NHS Foundation Trust, Reading, Berkshire, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': 'Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Renal Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Vilar', 'Affiliation': 'Renal Unit, East and North Hertfordshire NHS Trust, Stevenage, UK enric.vilar@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-035919']
1599,32792446,"The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size.","INTRODUCTION


At present, there is no approved medical treatment option for patients with non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression. In vivo somatostatin receptor imaging using  68 Ga-DOTATATE PET (PET, positron emission tomography) could help in preselecting patients potentially responsive to treatment. Our aim is to investigate the effect of the somatostatin analogue lanreotide as compared with placebo on tumour size in patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA).
METHODS AND ANALYSIS


The GALANT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA. Included patients undergo a  68 Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA are randomised in a 1:1 ratio between lanreotide 120 mg or placebo, both administered as subcutaneous injections every 28 days for 72 weeks. The primary outcome is the change in cranio-caudal tumour diameter on pituitary MRI after treatment. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. Final results are expected in the second half of 2021.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Medical Research Ethics Committee of the Academic Medical Centre (AMC) of the Amsterdam University Medical Centres and by the Dutch competent authority. It is an investigator-initiated study with financial support by Ipsen Farmaceutica BV. The AMC, as sponsor, remains owner of all data. Results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NL5136 (Netherlands Trial Register); pre-recruitment.",2020,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","['patients with a  68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA', 'Forty-four patients with a  68 Ga-DOTATATE PET-positive NFMA', 'patients with a  68   Ga  -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of  lan  reotide on  t  umour size', 'patients with non-functioning pituitary adenoma', 'adult patients with a suprasellar extending NFMA']","['somatostatin analogue lanreotide', 'lanreotide 120 mg or placebo', 'placebo']","['change in cranio-caudal tumour diameter on pituitary MRI', 'change in tumour volume, time to tumour progression, change in quality of life and number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C4256789', 'cui_str': 'dotatate'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0346308', 'cui_str': 'Pituitary macroadenoma'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023933', 'cui_str': 'LAN'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0338078', 'cui_str': 'Functionless pituitary adenoma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0230054', 'cui_str': 'Structure of suprasellar region'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.570073,"Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events.","[{'ForeName': 'Tessel M', 'Initials': 'TM', 'LastName': 'Boertien', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands t.m.boertien@amsterdamumc.nl.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Drent', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel P M', 'Initials': 'MPM', 'LastName': 'Stokkel', 'Affiliation': 'Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jantien', 'Initials': 'J', 'LastName': 'Hoogmoed', 'Affiliation': 'Department of Neurosurgery, Neurosurgical Centre Amsterdam, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Nienke R', 'Initials': 'NR', 'LastName': 'Biermasz', 'Affiliation': 'Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Simsek', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Groote Veldman', 'Affiliation': 'Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Michael W T', 'Initials': 'MWT', 'LastName': 'Tanck', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fliers', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bisschop', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-038250']
1600,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance


Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting.
Objective


To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD.
Interventions


Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks.
Design, Setting, and Participants


The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate.
Main Outcomes and Measures


Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed.
Results


A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred.
Conclusions and Relevance


In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134']
1601,32804205,Effect of High-Dose Erythropoietin on Blood Transfusions in Extremely Low Gestational Age Neonates: Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Extremely preterm infants are among the populations receiving the highest levels of transfusions. Erythropoietin has not been recommended for premature infants because most studies have not demonstrated a decrease in donor exposure.
Objectives


To determine whether high-dose erythropoietin given within 24 hours of birth through postmenstrual age of 32 completed weeks will decrease the need for blood transfusions.
Design, Setting, and Participants


The Preterm Erythropoietin Neuroprotection Trial (PENUT) is a randomized, double-masked clinical trial with participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States. Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days). Exclusion criteria included conditions known to affect neurodevelopmental outcomes. Of 3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to erythropoietin (n = 477) or placebo (n = 464). Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019.
Interventions


In this post hoc analysis, erythropoietin, 1000 U/kg, or placebo was given every 48 hours for 6 doses, followed by 400 U/kg or sham injections 3 times a week through postmenstrual age of 32 weeks.
Main Outcomes and Measures


Need for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level are presented herein.
Results


A total of 936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g. Erythropoietin treatment (vs placebo) decreased the number of transfusions (unadjusted mean [SD], 3.5 [4.0] vs 5.2 [4.4]), with a relative rate (RR) of 0.66 (95% CI, 0.59-0.75); the cumulative transfused volume (mean [SD], 47.6 [60.4] vs 76.3 [68.2] mL), with a mean difference of -25.7 (95% CI, 18.1-33.3) mL; and donor exposure (mean [SD], 1.6 [1.7] vs 2.4 [2.0]), with an RR of 0.67 (95% CI, 0.58-0.77). Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001). Of 936 infants, 160 (17.1%) remained transfusion free at the end of 12 postnatal weeks, including 43 in the placebo group and 117 in the erythropoietin group (P < .001).
Conclusions and Relevance


These findings suggest that high-dose erythropoietin as used in the PENUT protocol was effective in reducing transfusion needs in this population of extremely preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT01378273.",2020,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","['Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days', '936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g', '3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to', 'Extremely Low Gestational Age Neonates', 'participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States', 'Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019']","['Erythropoietin treatment (vs placebo', 'High-Dose Erythropoietin', 'erythropoietin', 'Erythropoietin', 'placebo']","['Measures\n\n\nNeed for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level', 'number of transfusions', 'Blood Transfusions', 'transfusion free', 'hematocrit levels', 'cumulative transfused volume']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",936.0,0.764264,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Neonatal-Perinatal Medicine, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Arkansas, Little Rock.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neonatal Medicine, Methodist Children's Hospital, San Antonio, Texas.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""Department of Neonatology, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City.'}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""Department of Neonatal Medicine, Maria Fareri Children's Hospital at Westchester, Valhalla, New York.""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Shea"", 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Department of Neonatology, Children's Minnesota, St Paul.""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Prentice Women's Hospital, Chicago, Illinois.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ohls', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of the University of Illinois, Chicago.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': 'Department of Neonatology, South Miami Hospital, South Miami, Florida.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""Department of Neonatology, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2271']
1602,32807654,Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508).,"INTRODUCTION


Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC.
PATIENTS AND METHODS


Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen.
RESULTS


Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
CONCLUSIONS


This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.",2020,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","['Patients with partial response/stable disease after consolidation therapy', 'Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity', 'Cancer (NS-NSCLC', 'Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA', 'patients with LA-NSCLC', 'Subjects with stage III NS-NSCLC suitable for CRT received', 'Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung', 'patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC']","['Immunotherapy With Tecemotide and Bevacizumab', 'Bevacizumab', 'tecemotide and bevacizumab', 'consolidation immunotherapy', 'chemoradiotherapy (CRT', 'carboplatin/paclitaxel weekly\xa0+ 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel', 'bevacizumab']","['Grade 5 toxicity', 'median progression-free survival', 'safety of this regimen', 'survival', 'median progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.311282,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","[{'ForeName': 'Jyoti D', 'Initials': 'JD', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, IL. Electronic address: jd-patel@northwestern.edu.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Data Science, Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Radiation Oncology, Penn State Cancer Institute, Hersey, PA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Maria Teresa P', 'Initials': 'MTP', 'LastName': 'de Aquino', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Millie S', 'Initials': 'MS', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care, Palo Alto, CA.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Al-Nsour', 'Affiliation': 'Mercy Cancer Centers, Toledo, OH.'}, {'ForeName': 'Christopher S R', 'Initials': 'CSR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Cancer Institute, Fairfax, VA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.007']
1603,32814640,"Assessment of indirect protection from maternal influenza immunization among non-vaccinated household family members in a randomized controlled trial in Sarlahi, Nepal.","Influenza is a significant cause of morbidity and mortality worldwide, and the World Health Organization highly recommends maternal vaccination during pregnancy. The indirect effect of maternal vaccination on other close contacts other than newborns is unknown. To evaluate this, we conducted a nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized placebo-controlled trial of antenatal influenza vaccination in the rural district of Sarlahi, Nepal. Women were assigned to receive influenza vaccination or placebo during pregnancy and then they and their household members were followed up to 6 months postpartum with weekly symptom surveillance and nasal swab collection. Swabs were tested by RT-PCR for influenza. Rates of laboratory-confirmed influenza and of ARI were compared between vaccine and placebo groups using generalized estimating equations with a Poisson link function. Overall, 1752 individuals in 520 households were eligible for inclusion. There were 82 laboratory-confirmed influenza illness episodes, for a rate of 7.0 per 100 person-years overall. Of the influenza strains able to be typed, 29 were influenza A, 40 were influenza B, and 6 were coinfections with influenza A and B. The rate did not differ significantly whether the household was in the vaccine or placebo group (rate ratio (RR) 1.37, 95% confidence interval (CI) 0.83-2.26). The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36). Influenza vaccination of pregnant women did not provide indirect protection of unvaccinated household members.",2020,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","['non-vaccinated household family members', 'unvaccinated household members', 'nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized', 'in the rural district of Sarlahi, Nepal', '1752 individuals in 520 households were eligible for inclusion', 'pregnant women']","['antenatal influenza vaccination', 'indirect protection from maternal influenza immunization', 'influenza vaccination or placebo', 'placebo']","['rate ratio (RR', 'rate of ARI']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",520.0,0.63193,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","[{'ForeName': 'Kira L', 'Initials': 'KL', 'LastName': 'Newman', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Laveta M', 'Initials': 'LM', 'LastName': 'Stewart', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital and Research Foundation, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Tribhuvan University, Department of Pediatrics and Child Health, Institute of Medicine, Kathmandu, Nepal.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Kuypers', 'Affiliation': 'School of Medicine, University of Washington, Molecular Virology Laboratory, Seattle, WA, USA.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA. Electronic address: helenchu@uw.edu.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.08.014']
1604,32815991,Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.,"Importance


The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
Objective


To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
Design, Setting, and Participants


The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.
Interventions


Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
Main Outcomes and Measures


The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
Results


A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.
Conclusions and Relevance


The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.
Trial Registration


ClinicalTrials.gov Identifier: NCT03007550.",2020,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","['214 patients', '105 patients in the LTG group and 109 patients in the OTG group', 'From January 2017 to September 2018, a total of 227 patients were enrolled', 'I Gastric Cancer', 'patients with clinical stage I gastric cancer']","['CLASS02', 'laparoscopic total gastrectomy (LTG', 'LTG', 'Laparoscopic vs Open Total Gastrectomy', 'LTG vs OTG with lymphadenectomy', 'conventional open total gastrectomy (OTG', 'OTG']","['overall morbidity and mortality rates', 'recovery courses and postoperative hospital stays', 'Intraoperative complications', 'mortality', 'distribution of complication severity', 'overall postoperative complication rate', 'morbidity and mortality', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}]","[{'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",227.0,0.250567,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","[{'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of General Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Naiqing', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.3152']
1605,32816002,Associations of Variation in Retinal Thickness With Visual Acuity and Anatomic Outcomes in Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With Anti-Vascular Endothelial Growth Factor Agents.,"Importance


When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
Objective


To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
Design, Setting, and Participants


In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Main Outcomes and Measures


Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Results


Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Conclusions and Relevance


Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.",2020,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","['1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years', 'Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020', 'eyes with nAMD initiating anti-VEGF treatment', 'Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included', 'patients with neovascular age-related macular degeneration (nAMD', 'Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With']","['anti-vascular endothelial growth factor (VEGF) treatment', 'Anti-Vascular Endothelial Growth Factor Agents']","['Measures\n\n\nFoveal center point thicknesses (FCPTs', 'risk of developing fibrosis and macular atrophy', 'median (interquartile range) FCPT SD']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.209385,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3001']
1606,32819842,Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa.,"RESEARCH QUESTION


The objective of this investigation was to determine the daily follitropin delta dose (µg) providing a similar ovarian response to 150 IU/day follitropin alfa.
DESIGN


The study was a post-hoc analysis of ovarian response in 1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol in two recent randomized, assessor-blind, controlled trials in the development programme for follitropin delta: a phase II dose-response trial with a reference arm of a fixed daily dose of 150 IU follitropin alfa throughout stimulation, and a phase III efficacy trial with a comparator arm of 150 IU/day follitropin alfa as a starting dose.
RESULTS


Daily follitropin delta doses of 10.0 µg (95% confidence interval [CI] 7.9-12.8) and 10.3 µg (95% CI 9.7-10.8) yielded the same number of oocytes as 150 IU/day follitropin alfa for all patients participating in the phase II and III trials, respectively. When analysing patients with either normal or high ovarian reserve (based on serum anti-Mullerian hormone ≥15 pmol/l) and no dose changes, the same number of oocytes was obtained with 150 IU/day follitropin alfa and daily doses of follitropin delta of 9.7 µg (95% CI 7.5-12.4) and 9.3 µg (95% CI 8.6-10.1) in the two trials. Daily follitropin delta doses in the range 9.5-10.4 µg were consistently estimated to correspond to 150 IU/day follitropin alfa for serum oestradiol concentration and number of follicles ≥12 mm at the end of stimulation across analysis populations in the phase III trial.
CONCLUSIONS


A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.",2020,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"['1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a', 'IVF/ICSI patients']","['gonadotrophin-releasing hormone antagonist protocol', 'daily follitropin delta dose (µg) providing a similar ovarian response to 150\xa0IU/day follitropin alfa']",['ovarian response'],"[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}]",[],,0.407696,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"[{'ForeName': 'Joan-Carles', 'Initials': 'JC', 'LastName': 'Arce', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine & Maternal Health, Copenhagen, Denmark. Electronic address: jca@ferring.com.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Larsson', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Copenhagen, Denmark.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'García-Velasco', 'Affiliation': 'IVI-RMA Madrid, Madrid, Spain.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.006']
1607,32819923,Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI.
METHODS AND ANALYSIS


This will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures.
ETHICS AND DISSEMINATION


This study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


This study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184).
TRIAL STATUS


The study was in the recruitment phase at the time of manuscript submission.",2020,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"['patients undergoing laparoscopic colon surgery', '146 subjects', 'American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery']","['TEAS/STEAS', 'TEAS', 'transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS', 'TEAS and sham TEAS (STEAS']","['time to first defaecation', 'postoperative ileus', 'time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3\u2009days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429979', 'cui_str': 'Independent walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}]",146.0,0.238662,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Dongli', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yong', 'Affiliation': 'Research Institute of Acupuncture Anesthesia, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guijie', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China fanlihua_ls@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030694']
1608,32819981,mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study.,"INTRODUCTION


Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.
METHODS AND ANALYSIS


In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.
ETHICS AND DISSEMINATION


The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03490253; pre-results.",2020,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","['low-income ethnic minority patients with comorbid diabetes and depression', 'diabetes and depression', '276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5']","['adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm', 'machine learning', 'text-messaging smartphone application']",['physical activity'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0707012,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Figueroa', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA c.a.figueroa@berkeley.edu.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Hernandez-Ramos', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Cemballi', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gomez-Pathak', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Miramontes', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Yom-Tov', 'Affiliation': 'Microsoft Research, Herzeliya, Israel.'}, {'ForeName': 'Bibhas', 'Initials': 'B', 'LastName': 'Chakraborty', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Modiri', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jay Williams', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034723']
1609,32819997,The VRIMM study: Virtual Reality for IMMunisation pain in young children-protocol for a randomised controlled trial.,"INTRODUCTION


Pain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive 'virtual world', has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.
METHODS AND ANALYSIS


The study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.
ETHICS AND DISSEMINATION


Ethics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.
TRIAL REGISTRATION NUMBER


ACTRN12618001363279.",2020,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"['100 children receiving routine 4-year-old vaccination', 'young children-protocol', 'Children attending a single general practice in metropolitan Melbourne, Australia', '4-year-old children receiving routine immunisations']","['VR intervention prior to vaccination in addition to standard care; the control group will receive standard care', 'Virtual reality (VR']","[""child's self-rated pain scores"", 'another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100\u2009mm visual analogue scales) and adverse effects', 'pain and distress', 'Faces Pain Scale-Revised']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.108349,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"[{'ForeName': 'Kirrily', 'Initials': 'K', 'LastName': 'Ellerton', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Harishan', 'Initials': 'H', 'LastName': 'Tharmarajah', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Medres', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ringelblum', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Kateena', 'Initials': 'K', 'LastName': 'Vogel', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dolphin', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'McKellar', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bridson', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'John-White', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia Simon.Craig@monashhealth.org.'}]",BMJ open,['10.1136/bmjopen-2020-038354']
1610,32819999,"Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol.","INTRODUCTION


Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP.
METHODS AND ANALYSIS


We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and funders.
TRIAL REGISTRATION NUMBER


ClinicalTrials: NCT04158492. EudraCT: 2018-004880-29.",2020,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","['community-acquired pneumonia (RADICAP', '440 subjects', 'patients with CAP', 'two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022']","['comprehensive molecular testing', 'EudraCT', 'experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing']","['de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death', 'antibiotic consumption']","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.28202,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Abelenda-Alonso', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain gabi.abelenda.alonso@gmail.com.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rombauts', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Meije', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ardanuy', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Niubó', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': ""Department of Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Department of Clinical Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Statistics Advisory Service, Institut d\\'Investigacio Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",BMJ open,['10.1136/bmjopen-2020-038957']
1611,32820000,"Study protocol for a double-blind, randomised placebo-controlled trial evaluating clinical effects of platelet-rich plasma injection for acute grade-2 hamstring tear among high performance athletes.","INTRODUCTION


Hamstring injury among athletes often results in significant morbidity. Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
METHODS AND ANALYSIS


This study is a single-centre double-blind randomised placebo-controlled trial. Sixty-eight patients will be randomised to receive under ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline. All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist. Outcome data will be collected before intervention (baseline), and thereafter on a weekly basis. The primary outcome measure is the duration to return-to-play. It is defined as the duration (in days) from the date on which the injury occurred until the patients were pain-free, able to perform the active knee extension test and have regained hamstring muscle strength. Secondary outcome measures include assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire. Both the primary and secondary outcomes were assessed at baseline and thereafter once a week until return to play. Also, hamstring injury recurrence within the first 6 months after recovery will be monitored via telephone. The results of this study will provide insights into the effect of LR-PRP in muscle and may help to identify the best PRP application protocol for muscle injuries.
ETHICS AND DISSEMINATION


Ethics approval were obtained from the Medical Research Ethics Committee of the University of Malaya Medical Centre. Results of this trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN76844299.",2020,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","['All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist', 'acute grade-2 hamstring tear among high performance athletes', 'Sixty-eight patients']","['ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline', 'platelet-rich plasma injection', 'placebo']","['hamstring injury recurrence', 'duration to return-to-play', 'assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450387', 'cui_str': '68'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",68.0,0.577388,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","[{'ForeName': 'Mohamad Shariff', 'Initials': 'MS', 'LastName': 'A Hamid', 'Affiliation': 'Sports Medicine, Universiti Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia ayip@um.edu.my.'}, {'ForeName': 'Kamarul Hashimy', 'Initials': 'KH', 'LastName': 'Hussein', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Ahmad Munawwar', 'Initials': 'AM', 'LastName': 'Helmi Salim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Puji', 'Affiliation': 'Department of Orthopaedic and Traumatology, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Rosnah', 'Initials': 'R', 'LastName': 'Mat Yatim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chin Chee', 'Initials': 'CC', 'LastName': 'Yong', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Thomas Wong Yong', 'Initials': 'TWY', 'LastName': 'Sheng', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}]",BMJ open,['10.1136/bmjopen-2020-039105']
1612,32781894,Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS).,"INTRODUCTION


Despite low mortality, cardiac surgery patients may experience serious life-threatening post-operative complications, often due to extracorporeal circulation and reperfusion. Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
METHODS


The COMICS trial is a multi-centre, international, two-group parallel randomised controlled trial testing whether type II, III or IV minimally invasive extracorporeal circulation is effective and cost-effective compared to conventional extracorporeal circulation in patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting + aortic valve replacement. Randomisation (1:1 ratio) is concealed and stratified by centre and surgical procedure. The primary outcome is a composite of 12 serious complications, objectively defined or adjudicated, 30 days after surgery. Secondary outcomes (at 30 days) include other serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90 days).
STATUS OF THE TRIAL


Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020). The recruitment rate from 01 April 2019 to 31 March 2020 was 40-50 patients/month. About 80% have had coronary artery bypass grafting only. Adherence to allocation is good.
CONCLUSIONS


The trial is feasible but criteria for progressing to a full trial were not met on time. The Trial Steering and Data Monitoring Committees have recommended that the trial should currently continue.",2020,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","['patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting\u2009+\u2009aortic valve replacement', 'patients undergoing cardiac surgery', 'Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020']","['Conventional versus minimally invasive extracorporeal circulation', 'Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['composite of 12 serious complications', 'serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.169333,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Perfusion,['10.1177/0267659120946731']
1613,32791499,Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.,"BACKGROUND


There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD.
METHODS


Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video.
RESULTS


Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%).
CONCLUSIONS


Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes.
TRIAL REGISTRATION


NCT02698722 (ClinicalTrials.gov).",2020,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","['Participants (age ≥ 65 years with advanced CKD', 'Older Patients', 'older patients with advanced CKD']","['verbal or video education', 'video decision aid', 'Supportive Kidney Care Video Decision Aid']","['knowledge of supportive kidney care', 'satisfaction and acceptability ratings', 'total health literacy score', 'preference for supportive kidney care', 'educational verbal script', 'knowledge of supportive kidney care (score range 0-3', 'preference for supportive kidney care, and satisfaction and acceptability of the video']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",100.0,0.12439,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","[{'ForeName': 'Nwamaka D', 'Initials': 'ND', 'LastName': 'Eneanya', 'Affiliation': 'Renal-Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, nwamaka.eneanya@pennmedicine.upenn.edu.'}, {'ForeName': 'Shananssa G', 'Initials': 'SG', 'LastName': 'Percy', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Stallings', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David J R', 'Initials': 'DJR', 'LastName': 'Steele', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Germain', 'Affiliation': 'Division of Nephrology, Baystate Medical Center, University of Massachusetts Medical School - Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Jane O', 'Initials': 'JO', 'LastName': 'Schell', 'Affiliation': 'Division of Renal-Electrolyte, Department of General Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",American journal of nephrology,['10.1159/000509711']
1614,32792098,Artificial neural network model for preoperative prediction of severe liver failure after hemihepatectomy in patients with hepatocellular carcinoma.,"BACKGROUND


Posthepatectomy liver failure is a worrisome complication after major hepatectomy for hepatocellular carcinoma and is the leading cause of postoperative mortality. Recommendations for hepatectomy for hepatocellular carcinoma are based on the risk of severe posthepatectomy liver failure, and accurately predicting posthepatectomy liver failure risk before undertaking major hepatectomy is of great significance. Thus, herein, we aimed to establish and validate an artificial neural network model to predict severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy.
METHODS


Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included. We randomly divided the patients into a development set (n = 265, 75%) and a validation set (n = 88, 25%). Multivariate logistic analysis facilitated identification of independent variables that we incorporated into the artificial neural network model to predict severe posthepatectomy liver failure in the development set and then verified in the validation set.
RESULTS


The morbidity of patients with severe posthepatectomy liver failure in the development and validation sets was 24.9% and 23.9%, respectively. Multivariate analysis revealed that platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant were all significant predictors of severe posthepatectomy liver failure. Incorporating these factors, the artificial neural network model showed satisfactory area under the receiver operating characteristic curve for the development set of 0.880 (95% confidence interval, 0.836-0.925) and for the validation set of 0.876 (95% confidence interval, 0.801-0.950) in predicting severe posthepatectomy liver failure and achieved well-fitted calibration ability. The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems. Moreover, stratification into 3 risk groups highlighted significant differences between the incidences and grades of posthepatectomy liver failure.
CONCLUSION


The artificial neural network model accurately predicted the risk of severe posthepatectomy liver failure in patients with hepatocellular carcinoma who underwent hemihepatectomy. Our artificial neural network model might help surgeons identify intermediate and high-risk patients to facilitate earlier interventions.",2020,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"['Three hundred and fifty-three patients who underwent hemihepatectomy for hepatocellular carcinoma were included', 'patients with hepatocellular carcinoma', 'patients with hepatocellular carcinoma who underwent hemihepatectomy']","['artificial neural network model', 'Artificial neural network model']","['platelet count, prothrombin time, total bilirubin, aspartate aminotransferase, and standardized future liver remnant', 'morbidity of patients with severe posthepatectomy liver failure']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087350', 'cui_str': 'Hemihepatectomy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}]",353.0,0.0387042,The predictive performance of the artificial neural network model for severe posthepatectomy liver failure outperformed the traditional logistic regression model and commonly used scoring systems.,"[{'ForeName': 'Rong-Yun', 'Initials': 'RY', 'LastName': 'Mai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Department of Experimental Research, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Hua-Ze', 'Initials': 'HZ', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liang', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China; Department of First Chemotherapy, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Bang-de', 'Initials': 'BD', 'LastName': 'Xiang', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Le-Qun', 'Initials': 'LQ', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.'}, {'ForeName': 'Jia-Zhou', 'Initials': 'JZ', 'LastName': 'Ye', 'Affiliation': 'Department of Hepatobiliary & Pancreatic Surgery, Guangxi Medical University Cancer Hospital, Nanning, China; Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China. Electronic address: yejiazhou2019@163.com.'}]",Surgery,['10.1016/j.surg.2020.06.031']
1615,32798787,"Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial.","AIMS


To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).
METHODS AND RESULTS


Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].
CONCLUSION


In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.",2020,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","['age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy', 'patients with heart failure (HF) and reduced ejection fraction (HFrEF', '582', 'Patients with mildly symptomatic HFrEF, mean (standard deviation (SD', 'patients with heart failure and reduced ejection fraction']","['Placebo', 'empagliflozin', 'sodium-glucose co-transporter-2 inhibitor empagliflozin', 'empagliflozin/placebo', 'HF therapy, empagliflozin', 'Empagliflozin', 'empagliflozin 10 mg once daily or placebo', 'placebo']","['daily activity level or health status', 'change of NT-proBNP', 'accelerometer-measured daily activity level', 'median (interquartile range (IQR', 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.793933,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark. Electronic address: jesper.jensen.06@regionh.dk.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Denmark; Clinical Institute, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jan Christian', 'Initials': 'JC', 'LastName': 'Brønd', 'Affiliation': 'RICH/EXE, Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.07.011']
1616,32804742,Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study.,"In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy. Patients were randomized in a 3:1 ratio to placebo or pimavanserin 34 mg daily added to ongoing antidepressant therapy. At 5 weeks, placebo nonresponders were rerandomized to placebo or pimavanserin for an additional 5 weeks. Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline. Least squares (LS) mean [standard error (SE)] difference between placebo and pimavanserin for the AS factor score was -1.5 (0.41) [95% confidence interval (CI) -2.4 to -0.7; P = 0.0003; effect size: 0.634]. Among patients with an AS factor score ≥7 at baseline, LS mean (SE) difference was -2.2 (0.66) (95% CI -3.5 to -0.9; P = 0.0013; effect size: 0.781). Response rates (≥50% reduction in HAMD-17 from baseline) were 22.4 and 55.2% (P = 0.0012) and remission rates (HAMD-17 total score <7) were 5.3 and 24.1% (P = 0.0047), respectively, with placebo and pimavanserin among patients with a baseline AS factor score ≥7. Among patients with anxious major depressive disorder at baseline, adjunctive pimavanserin was associated with a significant improvement.",2020,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"['patients with major depression and an inadequate response to previous therapy', 'patients with anxious major depressive disorder']","['placebo or pimavanserin', 'placebo and pimavanserin', 'pimavanserin', 'placebo']","['Least squares (LS) mean [standard error (SE)] difference', 'remission rates', 'Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor', 'anxious depression', 'Response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}]",,0.419589,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000328']
1617,32807194,Effects of the KEIGAAF intervention on the BMI z-score and energy balance-related behaviors of primary school-aged children.,"The aim of the current study was to evaluate the one- and two-year effectiveness of the KEIGAAF intervention, a school-based mutual adaptation intervention, on the BMI z-score (primary outcome), and energy balance-related behaviors (secondary outcomes) of children aged 7-10 years.A quasi-experimental study was conducted including eight intervention schools and three control schools located in low socioeconomic neighborhoods in the Netherlands. Baseline measurements were conducted in March and April 2017 and repeated after one and 2 years. Data were collected on children's BMI z-score, sedentary behavior (SB), physical activity (PA) behavior, and nutrition behavior through the use of anthropometric measurements, accelerometers, and questionnaires, respectively. All data were supplemented with demographics, and weather conditions data was added to the PA data. Based on the comprehensiveness of implemented physical activities, intervention schools were divided into schools having a comprehensive PA approach and schools having a less comprehensive approach. Intervention effects on continuous outcomes were analyzed using multiple linear mixed models and on binary outcome measures using generalized estimating equations. Intervention and control schools were compared, as well as comprehensive PA schools, less comprehensive PA schools, and control schools. Effect sizes (Cohen's d) were calculated.In total, 523 children participated. Children were on average 8.5 years old and 54% were girls. After 2 years, intervention children's BMI z-score decreased (B = -0.05, 95% CI -0.11;0.01) significantly compared to the control group (B = 0.20, 95% CI 0.09;0.31). Additionally, the intervention prevented an age-related decline in moderate-to-vigorous PA (MVPA) (%MVPA: B = 0.95, 95% CI 0.13;1.76). Negative intervention effects were seen on sugar-sweetened beverages and water consumption at school, due to larger favorable changes in the control group compared to the intervention group. After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.This study shows that the KEIGAAF intervention is effective in improving children's MVPA during school days and BMI z-score, especially in vulnerable children. Additionally, we advocate the implementation of a comprehensive approach to promote a healthy weight status, to stimulate children's PA levels, and to prevent children from spending excessive time on sedentary behaviors.Trial registrationNetherlands Trial Register, NTR6716 ( NL6528 ), Registered 27 June 2017 - retrospectively registered.",2020,"After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.","['Children were on average 8.5\u2009years old and 54% were girls', 'primary school-aged children', 'NTR6716 ( NL6528 ), Registered 27 June 2017 - retrospectively registered', 'children aged 7-10\u2009years', '523 children participated', 'eight intervention schools and three control schools located in low socioeconomic neighborhoods in the Netherlands']","['KEIGAAF intervention, a school-based mutual adaptation intervention', 'KEIGAAF intervention']","[""children's BMI z-score, sedentary behavior (SB), physical activity (PA) behavior, and nutrition behavior"", ""intervention children's BMI z-score"", 'BMI z-score and energy balance-related behaviors', 'BMI z-score, SB, and MVPA', 'moderate-to-vigorous PA (MVPA', 'BMI z-score (primary outcome), and energy balance-related behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",523.0,0.0178603,"After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.","[{'ForeName': 'Sacha R B', 'Initials': 'SRB', 'LastName': 'Verjans-Janssen', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands. s.verjans@maastrichtuniversity.nl.'}, {'ForeName': 'Sanne M P L', 'Initials': 'SMPL', 'LastName': 'Gerards', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}, {'ForeName': 'Stef P J', 'Initials': 'SPJ', 'LastName': 'Kremers', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Vos', 'Affiliation': 'Department of Industrial Design, Eindhoven University of Technology, 5612, AZ, Eindhoven, The Netherlands.'}, {'ForeName': 'Maria W J', 'Initials': 'MWJ', 'LastName': 'Jansen', 'Affiliation': 'Academic Collaborative Center for Public Health, Public Health Service South-Limburg, 6400, AA, Heerlen, The Netherlands.'}, {'ForeName': 'Dave H H', 'Initials': 'DHH', 'LastName': 'Van Kann', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01012-8']
1618,32808383,"Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial.","OBJECTIVES


This pilot trial tested the effect of adding a multi-level, technology-based physical activity intervention module to a standard survivorship care plan for breast and colorectal cancer survivors. The objective of this analysis was to determine whether the physical activity module improved health-related quality of life, sleep, and factors key to lasting behavior change (eg, social support, self-efficacy).
METHODS


Breast and colorectal cancer survivors (n = 50) were enrolled alongside a support partner. Survivors were assigned to receive a standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module. The module included a Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback. Physical activity was measured using the ActiGraph GT3X+. Psychosocial outcomes included the SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs. Data were analyzed using linear mixed modeling.
RESULTS


Cancer survivors were aged 54.4 ± 11.2 years and were 2.0 ± 1.5 years from diagnosis. Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d = 0.39, 95% CI = 0.0, 0.78), mental health (d = 0.59, 95% CI = 0.19, 0.99), sleep impairment (d = 0.62, 95% CI = -1.02, -0.22), and exercise self-efficacy (d = 0.60, 95% CI = 0.20, 1.0).
CONCLUSIONS


The intervention delivered meaningful improvements in survivors' quality of life, social support, and sleep impairment. If replicated in a larger sample, adding a technology-supported physical activity module to survivorship care plans may be a practical strategy for supporting healthy survivorship.
TRIAL REGISTRATION


ClinicalTrials.gov#: NCT02677389.",2020,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","['Cancer survivors were aged 54.4±11.2\u2009years and were 2.0±1.5\u2009years from diagnosis', 'breast and colorectal cancer survivors', 'cancer survivors', 'Breast and colorectal cancer survivors (n=50) were enrolled alongside a support partner']","['technology-supported physical activity intervention', 'multi-level, technology-based physical activity intervention module to a standard survivorship care plan', 'standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module', 'Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback']","['sleep impairment', 'exercise self-efficacy', 'health-related quality of life, sleep, and processes of behavior change', 'Physical activity', 'health-related quality of life, sleep, and factors key to lasting behavior change (e.g., social support, self-efficacy', ""survivors' quality of life, social support, and sleep impairment"", 'mental health', 'SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs', 'physical health']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.120099,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","[{'ForeName': 'Somya', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sesto', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Van Remortel', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Preshita', 'Initials': 'P', 'LastName': 'Date', 'Affiliation': 'Department of Anesthesiology, Montefiore Medical Center, The Bronx, New York, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Thraen-Borowski', 'Affiliation': 'Department of Kinesiology, Loras College, Dubuque, Iowa, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadmus-Bertram', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, Wisconsin, USA.'}]",Psycho-oncology,['10.1002/pon.5524']
1619,32808394,Effects of horse riding simulator on sitting motor function in children with spastic cerebral palsy.,"BACKGROUND


Horse riding simulator (HRS) is an electronic horse, working under the principles of hippotherapy. It is one of the advanced therapeutic methods to improve postural control and balance in sitting, which could be recommended in the rehabilitation of cerebral palsy if real horses are unavailable.
OBJECTIVE


To investigate the therapeutic effects of HRS on sitting motor function in children with spastic diplegia and evaluate the changes in sitting motor function at different periods of time (4, 8 and 12 weeks).
METHODS


This study is a randomized controlled trial conducted over a period of 12 weeks. Thirty children with spastic diplegia age between 2 and 4 years with Gross Motor Function Classification System (GMFCS) Level I-III were included and divided into two groups. The control group received the conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy. Sitting motor function was assessed by Gross Motor Function Measure (GMFM)-88 (sitting dimension B) at baseline, 4, 8 and 12 weeks. Pre- and post-intervention scores were measured and analysed.
RESULTS


The baseline characteristics were similar in both groups before the intervention with p > .01. The observed mean value of GMFM in both groups improved over a period of 12 weeks. The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
CONCLUSION


The study results confirmed that gradual improvement in sitting motor function was observed in both groups. Children exposed to HRS show better improvement than the children in the control group. It was concluded that HRS is effective in improving the sitting motor function in children with spastic diplegia and the continuous provision of HRS in longer duration provide more benefits than the shorter duration.",2020,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","['Thirty children with spastic diplegia age between 2 and 4\u2009years with Gross Motor Function Classification System (GMFCS', 'children with spastic cerebral palsy', 'children with spastic diplegia', 'Level I-III']","['horse riding simulator', 'conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy', 'HRS', 'Horse riding simulator (HRS']","['sitting motor function', 'mean value of GMFM', 'Gross Motor Function Measure (GMFM)-88 (sitting dimension B', 'Sitting motor function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.019812,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","[{'ForeName': 'Hemachithra', 'Initials': 'H', 'LastName': 'Chinniah', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Paediatrics, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'John William Felix', 'Initials': 'JWF', 'LastName': 'Ambrose', 'Affiliation': 'RMMC, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1870']
1620,32810194,"Parenting support to prevent overweight during regular well-child visits in 0-3 year old children (BBOFT+ program), a cluster randomized trial on the effectiveness on child BMI and health behaviors and parenting.","BACKGROUND


Prevention of overweight during early childhood seems promising.
OBJECTIVE


To evaluate the effectiveness of the parenting-based BBOFT+ overweight prevention program on child BMI, child health behavior and parenting behavior among 0-36 month old children. BBOFT+ is an acronym for the key healthy lifestyle behaviors that are targeted in the BBOFT+ intervention: breastfeeding (B), daily breakfast (B), daily going outdoors (O), limiting sweet beverages (in Dutch, F) and minimal TV or computer time (T), complemented with healthy sleep behavior and improvement of parenting skills (+).
METHODS


A cluster randomized controlled trial in newborn children visiting well-baby clinics, comparing the BBOFT+ intervention (N = 901) with care as usual (CAU) (N = 1094). In both groups, parents received regular well-child visits (±11 visits in the first 3 years). In the intervention group, care was supplemented with the BBOFT+ program, which focuses on improving parenting skills from birth onwards to increase healthy behavior. Questionnaires were filled in at child's age 2-4 weeks, 6, 14 and 36 months. In multivariate analyses we corrected for child's birthweight, age, ethnic background, mother's educational level and BMI.
RESULTS


No differences were found in weight status at 36 months between intervention and control group children. At 6 months, BBOFT+ parents reported their child drinking less sweet beverages than control parents (48% vs 54%;p = .027), and going outdoors daily with their child less often (57% vs 62%;p = .03). At 14 months, more BBOFT+ parents than control parents reported to have breastfed for six months or longer (32% vs 29%;p = .022). At 36 months, more BBOFT+ parents than control parents reported their child going outside daily (78% vs 72%;p = .011) and having less TV/computer time on week- (38% vs 46%;p = .001) and weekend days (48% vs 56%;p = .002). Also, BBOFT+ parents reported having more parental control than control parents (3.92 vs 3.89;p = .02). No significant differences were found for daily breakfast, sleep duration and parenting practices in adjusted analyses.
CONCLUSION


The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI. The identified modifiable elements are potentially relevant for interventions that aim to prevent overweight.",2020,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","['newborn children visiting well-baby clinics', 'N = 901) with care as usual (CAU) (N = 1094', 'overweight during regular well-child visits in 0-3 year old children (BBOFT+ program', 'child BMI, child health behavior and parenting behavior among 0-36 month old children']","['parenting-based BBOFT+ overweight prevention program', 'BBOFT+ intervention', 'BBOFT']","['child health behaviors', 'child BMI and health behaviors and parenting', 'child BMI', 'child going outside daily', 'daily breakfast, sleep duration and parenting practices', 'weight status']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0458075', 'cui_str': 'Well baby'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",901.0,0.0395653,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Vlasblom', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'van Grieken', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Beltman', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Monique P', 'Initials': 'MP', 'LastName': ""L'Hoir"", 'Affiliation': 'Department of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Raat', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Boere-Boonekamp', 'Affiliation': 'Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237564']
1621,32810203,Efficacy of high-power and short-duration ablation in patients with atrial fibrillation: a prospective randomized controlled trial.,"AIMS


The formation of radiofrequency lesions depends on the power and duration of ablation, and the contact force (CF). Although high power (HP) creates continuous and transmural lesions, most centres still use 25-30 W for 30-40 s for safety reasons. We evaluated the clinical efficacy and safety of a HP and short-duration (HPSD) strategy for atrial fibrillation (AF) ablation.
METHODS AND RESULTS


One hundred and fifty patients [58.2 ± 10.0 years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter were randomly assigned to three groups [30 W, 40 W, and 50 W at ablation sites of anterior, roof, and inferior segments of pulmonary vein (PV) antra and roof line between each upper PV]. In 25-30 W for ≤20 s was applied at posterior wall ablation site in all subjects. Compared with the 30 W and 40 W groups, procedure (P < 0.001) and ablation times (P < 0.001) were shorter and ablation number for PV isolation (P < 0.001) was smaller in the 50 W group. There were no significant differences in the CF and ablation index (AI) among the three groups. There were no significant differences in the procedure-related complication rates. During the 12-month follow-up, AF recurred in 24 (16%) patients with no significant difference among the groups (P = 0.769). In the multivariate analysis, non-PAF [hazard ratio (HR) 2.836, P = 0.045] and AI (HR 0.983, P = 0.001) were independent risk factors for AF recurrence.
CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.",2020,"CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.","['One hundred and fifty patients [58.2\u2009±\u200910.0\u2009years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter', 'patients with atrial fibrillation']","['HP and short-duration (HPSD) strategy', 'high-power and short-duration ablation', 'Radiofrequency ablation with HPSD']","['clinical efficacy and safety', 'shorter and ablation number for PV isolation', 'CF and ablation index (AI', 'ablation times', 'procedure-related complication rates']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",150.0,0.0286326,"CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.","[{'ForeName': 'Dong Geum', 'Initials': 'DG', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14068, Republic of Korea.'}, {'ForeName': 'Hong Euy', 'Initials': 'HE', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14068, Republic of Korea.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa144']
1622,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
1623,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
1624,32818641,The effect of laser-activated bleaching with 445 nm and 915 nm diode lasers on enamel micro-hardness; an in vitro study.,"BACKGROUND


The appearance of the teeth is of great importance to patients, particularly tooth color. In recent years, tooth whitening has been one of the most popular ways to restore tooth color. Bleaching gels can be affected by heat, light or laser, which can improve its effects. This study intends to examine the effects of two different wavelengths of diode laser (445 & 915 nm) after the bleaching process, on the enamel micro-hardness.
METHODS


A total of 65 caries-free humans third molars were randomly divided into five groups (N = 13): first group: bleaching gel activated with 915 nm diode laser (1.5 W), second: bleaching gel activated with 915-nm (2.5 W), third: bleaching gel activated with 445-nm (1 W), fourth: bleaching gel activated with 445-nm (1.5 W), fifth (control group): bleaching gel without laser activation. Micro-hardness test (Vickers test) was performed before and after the treatment. The data were submitted to repeated measurement ANOVA and Tukey's HSD post hoc test (α = 0.05).
RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2. Group 2 showed the most reduction in micro-hardness. There were no significant changes in the control group.
CONCLUSION


According to the results of this study, 445 nm Diode laser did not reduce enamel micro-hardness, making it suitable for bleaching treatments. However, more studies are required to consider other factors, such as color changes and pulp temperature.",2020,"RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2.",['65 caries-free humans third molars'],"['diode laser', 'bleaching gel activated with 915\u2009nm diode laser (1.5\u2009W), second: bleaching gel activated with 915-nm (2.5\u2009W), third: bleaching gel activated with 445-nm (1\u2009W), fourth: bleaching gel activated with 445-nm (1.5\u2009W), fifth (control group): bleaching gel without laser activation', 'laser-activated bleaching with 445\u2009nm and 915\u2009nm diode lasers']","['Enamel micro-hardness', 'micro-hardness']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",65.0,0.0117176,"RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2.","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Laser Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Rouzsaz', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mahboobehroozsaz@gmail.com.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shafie', 'Affiliation': 'Department of Dental Biomaterials, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sadra', 'Initials': 'S', 'LastName': 'Einizadeh', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Kharazifard', 'Affiliation': 'Dental Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Shahabi', 'Affiliation': 'Department of Dental Biomaterials, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahabis@sina.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101952']
1625,32776430,"Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines After Consumption of Coffee and Cocoa-Based Products Containing Coffee in a Repeated Dose, Crossover Human Intervention Study.","SCOPE


The present study assesses the absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites after daily regular exposure to specific dosages of coffee or cocoa-based products containing coffee (CBPCC), considering different patterns of consumption.
METHODS AND RESULTS


In a three-arm, crossover, randomized trial, 21 volunteers are requested to randomly consume for 1 month: one cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC twice per day. The last day of the one-month treatment, blood and urine samples are collected for 24 h. Trigonelline, N-methylpyridinium, N-methylnicotinamide, and N-methyl-4-pyridone-5-carboxamide are quantified. Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters. Moreover, inter-subject variability due to sex and smoking is assessed, showing sex-related differences in the metabolism of trigonelline and smoking-related ones for N-methylpyridinium.
CONCLUSION


The daily exposure to coffee pyridines after consumption of different coffee dosages in a real-life setting is established. This data will be useful for future studies aiming at evaluating the bioactivity of coffee-derived circulating metabolites in cell experiments, mimicking more realistic experimental conditions.",2020,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.",['21 volunteers are requested to randomly consume for 1 month: one'],"['Coffee and Cocoa-Based Products', 'cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC', 'coffee or cocoa-based products containing coffee (CBPCC', 'Trigonelline']","['Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines', 'absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0360301', 'cui_str': 'Product base'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0034251', 'cui_str': 'Pyridine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",21.0,0.0279235,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Bresciani', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tassotti', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dei Cas', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000489']
1626,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
1627,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1628,32657505,Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study.,"BACKGROUND AND AIMS


Lysosomal acid lipase deficiency is characterized by hepatomegaly and dyslipidaemia, which can lead to cirrhosis and premature atherosclerosis. Sebelipase alfa is an approved recombinant human lysosomal acid lipase. In an open-label extension study of adults with lysosomal acid lipase deficiency (LAL-CL04), sebelipase alfa treatment for 1 year reduced serum transaminase levels and liver fat content and improved serum lipid levels.
METHODS


Final data from LAL-CL04 are reported herein for patients who received sebelipase alfa infusions (1.0 or 3.0 mg/kg every other week) for up to 5 years.
RESULTS


Of 8 patients enrolled, 7 received sebelipase alfa for 224-260 weeks; 1 was lost to follow-up. Median baseline levels of alanine aminotransferase and aspartate aminotransferase (81.5 and 50.0 U/L, respectively) were decreased through the end-of-study visit (54.0 and 34.0 U/L). Median low-density lipoprotein cholesterol decreased from 113 to 78 mg/dL, total cholesterol decreased from 171 to 132 mg/dL, and high-density lipoprotein cholesterol increased from 37 to 42 mg/dL. Most treatment-emergent adverse events were nonserious (99%), mild/moderate (98%) and unrelated to sebelipase alfa (87%); no patient discontinued as a result of treatment-emergent adverse events. One patient had 2 serious treatment-emergent adverse events (cholecystitis and cholelithiasis; assessed as unlikely related to sebelipase alfa). Two patients had 20 nonserious infusion-associated reactions in weeks 6-38; all were manageable. One patient tested positive for antidrug antibodies (single occurrence).
CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov record NCT01488097.",2020,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","['adults with lysosomal acid lipase deficiency (LAL-CL04', 'adults with lysosomal acid lipase deficiency', 'Of 8 patients enrolled']","['Sebelipase alfa', 'sebelipase alfa infusions']","['Median baseline levels of alanine aminotransferase and aspartate aminotransferase', 'tolerated and improved serum transaminase and lipid levels', 'total cholesterol', 'high-density lipoprotein cholesterol', 'serum transaminase levels and liver fat content and improved serum lipid levels', 'Median low-density lipoprotein cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4050579', 'cui_str': 'sebelipase alfa'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",8.0,0.0400227,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","[{'ForeName': 'Vĕra', 'Initials': 'V', 'LastName': 'Malinová', 'Affiliation': ""Department for Metabolic Diseases, Children's Clinic, General Faculty Hospital and First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences and Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology and Metabolic Medicine, Salford Royal Foundation NHS Trust, Salford, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Department of Inherited Metabolic Diseases, Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kane', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'Advanced Therapies Program, and Gene Therapy Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Marulkar', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Abel', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14603']
1629,32782170,Effect of GnRH agonist before IVF on outcomes in infertile endometriosis patients: a randomized controlled trial.,"RESEARCH QUESTION


Does 3-months of gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF improve clinical pregnancy rate in infertile patients with endometriosis?
DESIGN


Single-blind, placebo-controlled clinical trial of 200 infertile women with endometriosis assigned to use GnRHa (study group) or placebo (control group) for 3 months before IVF. Clinical, embryological outcomes and stimulation parameters were analysed. Clinical pregnancy rate was the primary endpoint. In a subgroup of 40 patients, follicular fluid levels of oestradiol, testosterone and androstendione were measured. Gene expression profile of CYP19A1 was analysed in cumulus and mural granulosa cells.
RESULTS


Implantation or clinical pregnancy rate were not significantly different between the two groups. Clinical pregnancy rates were 25.3% and 33.7% in the study and control groups, respectively (P = 0.212). Cumulative live birth rate was not significantly different: 22.0% (95% CI 13.0 to 31.0) in the study group and 33.7% (95% CI 24.0 to 44.0) in the control group (P = 0.077). Ovarian stimulation was significantly longer and total dose of gonadotrophins significantly higher in the study group (both P < 0.001). Serum oestradiol levels on the day of HCG were significantly lower in the study group (P = 0.001). Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023). No significant differences in the expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid between the two groups were observed, but testosterone was significantly lower in the study group (P < 0.001).
CONCLUSION


Three-months of GnRHa treatment before IVF does not improve clinical pregnancy rate in women with endometriosis.",2020,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","['infertile endometriosis patients', '200 infertile women with endometriosis assigned to use GnRHa (study group) or', 'infertile patients with endometriosis', 'women with endometriosis']","['GnRH agonist before IVF', 'gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF', 'placebo']","['clinical pregnancy rate', 'Clinical pregnancy rate', 'Ovarian stimulation', 'total dose of gonadotrophins', 'cleavage embryos', 'Cancellation rate', 'Cumulative live birth rate', 'Implantation or clinical pregnancy rate', 'Serum oestradiol levels', 'expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid', 'Clinical pregnancy rates', 'follicular fluid levels of oestradiol, testosterone and androstendione', 'Gene expression profile of CYP19A1']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0441995', 'cui_str': 'Mural'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}]",200.0,0.487422,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rodríguez-Tárrega', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain. Electronic address: e.rodriguez.tarrega@gmail.com.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Monzo', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Quiroga', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Polo-Sánchez', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fernández-Colom', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Monterde-Estrada', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Novella-Maestre', 'Affiliation': 'Genetic Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': 'Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; IVI Rome. Largo Ildebrando Pizzeti, Rome 00197, Italy.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.06.020']
1630,32783644,Lasmiditan in patients with common migraine comorbidities: a  post hoc  efficacy and safety analysis of two phase 3 randomized clinical trials.,"OBJECTIVE


Determine whether common migraine comorbidities affect the efficacy and safety of lasmiditan, a 5-HT 1F  receptor agonist approved in the United States for the acute treatment of migraine.
METHODS


In SPARTAN and SAMURAI (double-blind Phase 3 clinical trials), patients with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100mg, 200 mg, or placebo. Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 h after dose compared with placebo. Most common treatment-emergent adverse events (TEAEs) were dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia. Based upon literature review of common migraine comorbidities, Anxiety, Allergy, Bronchial, Cardiac, Depression, Fatigue, Gastrointestinal, Hormonal, Musculoskeletal/Pain, Neurological, Obesity, Sleep, and Vascular Comorbidity Groups were created. Using pooled results, efficacy and TEAEs were assessed to compare patients with or without a given common migraine comorbidity. To compare treatment groups,  p -values were calculated for treatment-by-subgroup interaction, based on logistic regression with treatment-by-comorbidity condition status (Yes/No) as the interaction term; study, treatment group, and comorbidity condition status (Yes/No) were covariates. Differential treatment effect based upon comorbidity status was also examined. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).
RESULTS


Across all the Comorbidity Groups, with the potential exception of fatigue, treatment-by-subgroup interaction analyses did not provide evidence of a lasmiditan-driven lasmiditan versus placebo differential treatment effect dependent on Yes versus No comorbidity subgroup for either efficacy or TEAE assessments.
CONCLUSIONS


The efficacy and safety of lasmiditan for treatment of individual migraine attacks appear to be independent of comorbid conditions.",2020,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"['patients with or without a given common migraine comorbidity', 'patients with migraine', 'patients with common migraine comorbidities']","['oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo', 'lasmiditan', 'placebo']","['dizziness, paraesthesia, somnolence, fatigue, nausea, muscular weakness, and hypoesthesia', 'proportion of pain-free and most bothersome symptom']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151786', 'cui_str': 'Muscle weakness'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.166168,Lasmiditan increased the proportion of pain-free and most bothersome symptom (MBS)-free patients at 2 hours after dose compared with placebo.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clemow', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Simin K', 'Initials': 'SK', 'LastName': 'Baygani', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hauck', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cory B', 'Initials': 'CB', 'LastName': 'Hultman', 'Affiliation': 'Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1808780']
1631,32790921,Histological and histomorphometrical outcome after lateral guided bone regeneration augmentation of the mandible with different ratios of deproteinized bovine bone mineral and autogenous bone. A preclinical in vivo study.,"OBJECTIVE


To test the hypotheses of no differences in (I) percentage of bone (POB), non-mineralized tissue (NMT), and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone after lateral guided bone regeneration (GBR) augmentation of the mandible with different ratios of DBBM and particulate autogenous bone (PAB) at different time points.
MATERIAL AND METHODS


Twenty-four minipigs were randomly allocated into three groups. Lateral augmentation in 96 sites (4 in each animal) was performed unilaterally with a standardized quantity of grafting material in each animal with different ratios of DBBM and PAB (50:50, 75:25, 100:0) and autogenous bone block in combination with DBBM and covered with a collagen membrane. The percentage of different tissues in the graft and ingrowth of mineralized bone was assessed by histomorphometrical and histological analyses after 10, 20, and 30 weeks, respectively.
RESULTS


The POB was 54% (50:50), 50% (75:25), and 48% (100:0) after 10 weeks, 60% (50:50), 61% (75:25), and 60% (100:0) after 20 weeks, and 63% (50:50), 62% (75:25), and 62% (100:0) after 30 weeks. There was no significant difference between the groups at any time points. There was a significant increase in POB and a significant decrease in NMT for 75:25 and 100:0 from 10 to 30 weeks. All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
CONCLUSION


Within the limitations of the present study, it seems like addition of autogenous bone to DBBM for LRA did not affect the bone formation nor graft incorporation after 10-30 weeks of healing. However, a prolonged healing time seems to result in an increased POB for all ratios.",2020,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
",['Twenty-four minipigs'],"['autogenous bone block in combination with DBBM and covered with a collagen membrane', 'deproteinized bovine bone mineral and autogenous bone']","['bone formation nor graft incorporation', 'bone (POB), non-mineralized tissue (NMT) and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone', 'POB', 'NMT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",24.0,0.0558712,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Aludden', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Mordenfeld', 'Affiliation': 'Plastic and Oral & Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Dahlin', 'Affiliation': 'Department of Biomaterials, BIOMATCELL VINN Excellence center, Institute for Surgical Science, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Gävle County Hospital, Gävle, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}]",Clinical oral implants research,['10.1111/clr.13649']
1632,32792250,"Acceptability of an inactivated influenza vaccine delivered by microneedle patch: Results from a phase I clinical trial of safety, reactogenicity, and immunogenicity.","OBJECTIVE


This study sought to evaluate the acceptability of inactivated influenza vaccine delivered by microneedle patch (MNP) in comparison to inactivated influenza vaccine (IIV) delivered by hypodermic needle.
DESIGN, SETTING, AND PARTICIPANTS


From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49 years. Main Outcome(s) and Measure(s). Our participants were randomized to 4 groups of 25 per arm: (1) IIV by MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW. We administered four questionnaires: at Day 0 before and after study product delivery, and at Days 8 and 28.
RESULTS


At baseline, 98.6% of participants receiving MNP vaccination reported an overall positive experience with MNPs, compared to 86.4% for participants receiving IM vaccination. For future influenza vaccination, study participants (N = 99) preferred MNP (n = 65, 69.9%) to injections or nasal spray (n = 20, 21.5%), and the preference for MNP increased from Day 0 to Day 28. Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
CONCLUSIONS AND RELEVANCE


Most participants were accepting of IIV vaccination by MNP and preferred it to injection. Delivery of IIV by MNP may help increase vaccination coverage.",2020,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","['From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49\xa0years']","['inactivated influenza vaccine delivered by microneedle patch', 'influenza vaccine (IIV) delivered by hypodermic needle', 'injections or nasal spray', 'MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW', 'MNP', 'inactivated influenza vaccine delivered by microneedle patch (MNP']","['mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge', 'overall positive experience with MNPs', 'MNP Use Perceptions', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0221093', 'cui_str': 'Hypodermic needle'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282245', 'cui_str': 'Northern Mariana Islands'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.034005,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","[{'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Frew', 'Affiliation': 'The University of Nevada, Las Vegas, School of Public Health, United States; UNLV Population Health & Health Equity Initiative, United States. Electronic address: paula.frew@unlv.edu.'}, {'ForeName': 'Michele Bennett', 'Initials': 'MB', 'LastName': 'Paine', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Schamel', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Yunmi', 'Initials': 'Y', 'LastName': 'Chung', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'NYU Langone Health, Division of Infectious Diseases and Immunology, United States.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Prausnitz', 'Affiliation': 'Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.07.064']
1633,32792449,Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial.,"INTRODUCTION


Temporomandibular disorders (TMDs) are considered a collection of musculoskeletal conditions involving the masticatory muscles, the temporomandibular joint and associated structures. The myogenous group appears to represent the most frequently diagnosed category. In the context of a multimodal approach, splint therapy and musculoskeletal physiotherapy are often considered as a preferred therapy. The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
METHODS AND ANALYSIS


All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible. Inclusion criteria shall be based on the presence of myogenous TMDs, as diagnosed through clinical examination in reference to the international diagnostic criteria of TMDs. Randomisation, concealed allocation, blinded assessment and intention-to-treat analysis will be employed. The splint therapy will consist of the use of the splint every night and concurrent delivery of an educational programme; the protocol shall have a duration of three consecutive months. The combined musculoskeletal physiotherapy, splint therapy and education will additionally consist of manual therapy techniques and exercise; such protocol shall consist of a duration of three consecutive months, inclusive of 10 sessions for the enhanced elements. All outcome measures will be collected at baseline, after treatment and at a 6 months follow-up.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Independent Ethic Committee in Clinical Research of AUSL Bologna-Italy (47/2018/SPER/AUSLBO). Pursuant to applicable rules,we will obtain informed consent from each participant and collect data anonymously to maintain privacy. Results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences.
TRIAL REGISTRATION NUMBER


NCT03726060.",2020,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","['myogenic temporomandibular disorders', 'All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible']","['musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone', 'occlusal splint', 'physical therapy']",['pain and mandibular range of motion'],"[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",,0.0617932,"The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Incorvati', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy cristina.incorvati@unibo.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Romeo', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Fabrizi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Defila', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Vanti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Maria Rosaria Antonella', 'Initials': 'MRA', 'LastName': 'Gatto', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences(DIBINEM) Medical Statistics, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Oral and Maxillofacial Surgery, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pillastrini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences (DIBINEM) Phisical Therapy, Alma Mater Studiorum University of Bologna, Bologna, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-038438']
1634,32792454,"TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial.","INTRODUCTION


Neurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI.
METHODS AND ANALYSIS


TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5-39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6-9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome.
ETHICS AND DISSEMINATION


TASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03965299.",2020,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","['A planned 114 participants', 'patients with acute spinal cord injury to prevent neurogenic detrusor overactivity']","['TASCI-transcutaneous tibial nerve stimulation', 'Transcutaneous tibial nerve stimulation (TTNS', 'TTNS', 'verum or sham TTNS']","['occurrence of NDO jeopardising the upper urinary tract at 1\u2009year after SCI, assessed by urodynamic investigation', 'bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue']","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0341736', 'cui_str': 'Neurogenic detrusor overactivity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",114.0,0.485529,"The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Collene E', 'Initials': 'CE', 'LastName': 'Anderson', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc., Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumberger', 'Affiliation': 'Spinal Cord and Rehabilitation Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Birder', 'Affiliation': 'Neuro-Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Botter', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Silvan', 'Initials': 'S', 'LastName': 'Büeler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Célia D', 'Initials': 'CD', 'LastName': 'Cruz', 'Affiliation': 'Instituto de Investigação e Inovação em Saúde, Translational Neuro-urology Group, Universidade do Porto, Porto, Portugal.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'David', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Freund', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Friedl', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gross', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Margret', 'Initials': 'M', 'LastName': 'Hund-Georgiadis', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Husmann', 'Affiliation': 'Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jordan', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koschorke', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Luca', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Möhr', 'Affiliation': 'Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Freschta', 'Initials': 'F', 'LastName': 'Mohammadzada', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Monastyrskaya', 'Affiliation': 'Urology Research Laboratory, DBMR, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Pfender', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sadri', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Sartori', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sprengel', 'Affiliation': 'Department of Trauma, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jivko', 'Initials': 'J', 'LastName': 'Stoyanov', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Stress', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Tatu', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tawadros', 'Affiliation': 'Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wöllner', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Zubler', 'Affiliation': 'Department of Radiology, Balgrist University Hospital, Zürich, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Curt', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Pannek', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland tkessler@gmx.ch.'}]",BMJ open,['10.1136/bmjopen-2020-039164']
1635,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1636,32796259,Comparison of Supervised and Telehealth Delivery of Worksite Exercise for Prevention of Low Back Pain in Firefighters: A Cluster Randomized Trial.,"OBJECTIVE


This study assessed worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT) related to low back pain (LBP) in firefighters.
METHODS


A cluster randomized controlled trial assigned 264 career firefighters to supervised (n = 86) or telehealth (n = 95) back and core exercises 2×/week for 12 months, or control (n = 83).
RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = 5, telehealth n = 5). Participants in the control group experienced 1.15 times as many hours of LWT as the supervised group, and 5.51 times as many hours of LWT as the telehealth group.
CONCLUSIONS


Worksite exercise, delivered by on-site supervision or telehealth, can reduce LWT related to LBP in career firefighters.",2020,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ",['Low Back Pain in Firefighters'],"['Supervised and Telehealth Delivery of Worksite Exercise', '264 career firefighters to supervised (n\u200a=\u200a86) or telehealth (n\u200a=\u200a95) back and core exercises 2X/week for 12 months, or control', 'worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT', 'Worksite exercise']",[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],264.0,0.0476192,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mayer', 'Affiliation': 'US Spine & Sport Foundation, San Diego, California (Dr Mayer, Ms Lane, Dr Johnson), Tampa, Florida (Dr Brady), University of South Florida, Tampa, Florida (Dr Chen, Ms Lu), Spine Research LLC, Winchester, Massachusetts (Dr Dagenais).'}, {'ForeName': 'Charity L', 'Initials': 'CL', 'LastName': 'Lane', 'Affiliation': ''}, {'ForeName': ""O'Dane"", 'Initials': 'O', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Henian', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Brittany V B', 'Initials': 'BVB', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dagenais', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001993']
1637,32799029,Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women.,"STUDY OBJECTIVES


To determine whether insomnia patients with objective sleep disturbance are less responsive to cognitive and behavioral treatments than those without objective sleep disturbance, characterize effects of insomnia therapy on objective sleep, and determine whether reductions in nocturnal cognitive arousal correspond to changes in objective sleep.
METHODS


Secondary analysis of a single-site, randomized controlled trial. 113 postmenopausal women (56.40 ± 5.34 years) with menopause-related insomnia disorder were randomized to three treatment conditions: cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control. Primary outcomes were the Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters and were collected at pretreatment, posttreatment, and six-month follow-up.
RESULTS


Patients with lower pretreatment PSG sleep efficiency had lower rates of insomnia remission after active treatment relative to those with higher sleep efficiency (37.8% vs 61.8%). Neither CBTI and SRT produced clinically meaningful effects on PSG sleep. Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
CONCLUSIONS


Our findings support an emerging literature suggesting that insomnia patients with objective sleep disturbance may have blunted response to insomnia therapy. Research is needed to enhance treatments to better improve insomnia in patients with objective sleep disturbance. A lack of observed CBTI and SRT effects on PSG sleep suggests that these therapies may be presently ill-designed to improve objective sleep. Nocturnal cognitive arousal may represent an entry point to improve objective sleep latency in insomnia. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.",2020,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","['insomnia patients with objective sleep disturbance', 'postmenopausal women', 'patients with objective sleep disturbance', '113 postmenopausal women (56.40\xa0±\xa05.34 years) with menopause-related insomnia disorder']","['NAME', 'CBTI and SRT', 'cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control']","['Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters', 'PSG sleep', 'nocturnal cognitive arousal', 'Nocturnal cognitive arousal', 'PSG sleep latency', 'sleep efficiency', 'insomnia remission']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",113.0,0.0431924,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Sagong', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA. Electronic address: cdrake1@hfhs.org.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.024']
1638,32807252,Comparing the effects of whey and casein supplementation on nutritional status and immune parameters in patients with chronic liver disease: a randomised double-blind controlled trial.,"Protein supplementation may be beneficial for patients with chronic liver disease (CLD). This study compared the effects of whey protein isolate (WP) and casein (CA) supplementation on nutritional status and immune parameters of CLD patients who were randomly assigned to take 20 g of WP or CA twice per d as a supplement for 15 d. Body composition, muscle functionality and plasmatic immunomarkers were assessed before and after supplementation. Patients were also classified according to the model for end-stage liver disease (MELD) into less (MELD < 15) and more (MELD ≥ 15) severe disease groups. Malnutrition, determined by the Subjective Global Assessment at baseline, was observed in 57·4 % and 54·2 % of patients in the WP and CA groups, respectively (P = 0·649). Protein intake was lower at baseline in the WP group than in the CA group (P = 0·035), with no difference after supplementation (P = 0·410). Both the WP and CA MELD < 15 groups increased protein intake after supplementation according to the intragroup analysis. No differences were observed in body composition, muscle functionality, most plasma cytokines (TNF, IL-6, IL-1β and interferon-γ), immunomodulatory proteins (sTNFR1, sTNFR2, brain-derived neurotrophic factor and glial cell line-derived neurotrophic factor) or immunomodulatory hormones (adiponectin, insulin and leptin) after supplementation in the WP groups at the two assessed moments. WP supplementation increased the levels of interferon-γ-induced protein-10/CXCL10 (P = 0·022), eotaxin-1/CCL11 (P = 0·031) and monocyte chemoattractant protein-1/CCL2 (P = 0·018) and decreased IL-5 (P = 0·027), including among those in the MELD ≥ 15 group, for whom IL-10 was also increased (P = 0·008). Thus, WP consumption by patients with CLD impacted the immunomodulatory responses when compared with CA with no impact on nutritional status.",2020,"WP supplementation increased the levels of IP-10/CXCL10 (p=0.022), eotaxin-1/CCL11","['CLD patients', 'patients with chronic liver disease (CLD', 'Patients were also classified according to the model for end-stage liver disease (MELD) into less (MELD <15) and more (MELD≥15) more severe disease groups']","['Protein supplementation', 'CA', 'WP and CA MELD<15', 'MCP-1/CCL2', 'WP supplementation', 'whey protein isolate (WP) and casein (CA) supplementation', 'WP or CA', 'eotaxin-1/CCL11']","['Protein intake', 'Subjective Global Assessment', 'protein intake', 'levels of IP-10/CXCL10', 'Body composition, muscle functionality and plasmatic immunomarkers', 'body composition, muscle functionality, most plasma cytokines (TNF, IL-6, IL-1β and IFN-γ), immunomodulatory proteins (sTNFR1, sTNFR2, BDNF and GDNF), or immunomodulatory hormones (adiponectin, insulin, and leptin', 'IL-5']","[{'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell-Line Derived Neurotrophic Factor'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}]",,0.0436261,"WP supplementation increased the levels of IP-10/CXCL10 (p=0.022), eotaxin-1/CCL11","[{'ForeName': 'Y G G', 'Initials': 'YGG', 'LastName': 'Mizubuti', 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'E L M', 'Initials': 'ELM', 'LastName': 'Vieira', 'Affiliation': 'Department of Biochemistry and Immunology, Neuroscience Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Silva', 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': ""d'Alessandro"", 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Generoso', 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Department of Biochemistry and Immunology, Neuroscience Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Lima', 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}, {'ForeName': 'M I T D', 'Initials': 'MITD', 'LastName': 'Correia', 'Affiliation': 'Department of Surgery, University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais30130-100, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114520003219']
1639,32826776,Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings.,"BACKGROUND


Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans.
OBJECTIVES


We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings.
RESEARCH DESIGN


Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies.
SUBJECTS


Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings.
RESULTS


At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design.
CONCLUSIONS


A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.",2020,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,['Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings'],[],[],"[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],[],,0.194153,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Purcell', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Becker', 'Affiliation': 'VA Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Kara A', 'Initials': 'KA', 'LastName': 'Zamora', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGrath', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Hildi J', 'Initials': 'HJ', 'LastName': 'Hagedorn', 'Affiliation': 'Minneapolis VA Health Care System.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Fabian', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'McCamish', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Seal', 'Affiliation': 'San Francisco VA Health Care System.'}]",Medical care,['10.1097/MLR.0000000000001376']
1640,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1641,32798567,High Early Parenteral Lipid in Very Preterm Infants: A Randomized-Controlled Trial.,"OBJECTIVE


To determine whether high early parenteral soybean oil lipid intake in very low birth weight (VLBW) infants in the first week after birth decreases the proportion of weight loss and subsequently the incidence of extrauterine growth restriction (EUGR).
STUDY DESIGN


This was a randomized controlled trial of appropriate for gestational- ge VLBW infants. Lipid intake in the control group started at 0.5-1 g/kg per day and increased daily by 0.5-1 g/kg per day till reaching 3 g/kg per day. The intervention group was started on 2 g/kg per day that increased to 3 g/kg per day the following day.
RESULTS


Of the 176 infants assessed for eligibility, 83 were included in the trial. Infants in the intervention group were started on lipid sooner (13.8 ± 7.8 vs 17.5 ± 7.8 hour; P = .03) and had higher cumulative lipid intake in the first 7 days of age (13.5 ± 4.2 vs 10.9 ± 3.5 g/kg per day; P = .03). Infants in the intervention group had a lower percentage of weight loss (10.4 vs 12.7%; P = .02). The mean triglyceride level was higher in the intervention group (1.91 ± 0.79 vs 1.49 ± 0.54 mmol/L; P = .01), however, hypertriglyceridemia was similar between the 2 groups. The incidence of EUGR was lower in the intervention group (38.6% vs 67.6%; P = .01). Head circumference z score was higher in the intervention group (-1.09 ± 0.96 vs -1.59 ± 0.98; P = .04).
CONCLUSIONS


In VLBW infants, provision of a high early dose of parenteral lipid in the first week of age results in less weight loss and lower incidence of EUGR.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03594474.",2020,"The mean triglyceride level was higher in the intervention group (1.91±0.79 vs. 1.49±0.54 mmol/L; P= 0.01), however, hypertriglyceridemia was similar between the two groups.","['Very Preterm Infants', '176 infants assessed for eligibility', 'gestational-age VLBW infants']",['high early parenteral soybean oil lipid intake'],"['weight loss and lower incidence of EUGR', 'cumulative lipid intake', 'lipid sooner', 'incidence of EUGR', 'hypertriglyceridemia', 'mean triglyceride level', 'Lipid intake', 'weight loss', 'Head circumference Z-score']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",176.0,0.102319,"The mean triglyceride level was higher in the intervention group (1.91±0.79 vs. 1.49±0.54 mmol/L; P= 0.01), however, hypertriglyceridemia was similar between the two groups.","[{'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Alburaki', 'Affiliation': 'Neonatal Nutritional and Gastroenterology Program, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Yusuf', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Dobry', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sheinfeld', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alshaikh', 'Affiliation': 'Neonatal Nutritional and Gastroenterology Program, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada. Electronic address: balshaik@ucalgary.ca.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.024']
1642,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1643,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1644,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1645,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND


In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS


PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS


At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS


In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
1646,32801193,REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.,"INTRODUCTION


Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as ' Managing Fatigue: A 6 week energy conservation course' , can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the  Managing Fatigue  intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function.
METHODS AND ANALYSIS


A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2 months, 3 months and 6 months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the  Managing Fatigue  intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes.
ETHICS AND DISSEMINATION


The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03550170; Pre-results.",2020,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","['persons with multiple sclerosis', 'young adults', 'Eligible participants give consent before being enrolled and randomised into the study', '582 participants with MS living in the Midwestern and Northeastern United States']",['Managing Fatigue  intervention-two remote delivery formats (teleconference and internet'],"['MS fatigue', 'quality of life, including physical, mental and social function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",582.0,0.146994,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Plow', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA map208@case.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Packer', 'Affiliation': 'School of Occupational Therapy and School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Virgil G', 'Initials': 'VG', 'LastName': 'Mathiowetz', 'Affiliation': 'Program in Occupational Therapy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Preissner', 'Affiliation': 'Department of Occupational Therapy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Ghahari', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035470']
1647,32801202,"Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.","INTRODUCTION


The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm.
METHODS AND ANALYSIS


A 12-week three-arm, double-blind, randomised controlled supplementation trial was conducted in Cambodia to determine if there is potential harm associated with untargeted iron supplementation. We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo. We will measure ferritin concentrations (to evaluate non-inferiority between the two forms of iron), as well as markers of potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage) at baseline and 12 weeks. Mixed-effects generalised linear models will be used to assess the effect of iron on ferritin concentration and markers of potential harm at 12 weeks.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of British Columbia Clinical Research Ethics Board (H18-02610), the Children's and Women's Health Centre of British Columbia Research Ethics Board (H18-02610) and the National Ethics Committee for Health Research in Cambodia (273-NECHR). Findings will be published in peer-reviewed journals, presented to stakeholders and policymakers globally and shared within participants' communities.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04017598).",2020,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","['non-pregnant Cambodian women', '480 non-pregnant women (ages 18-45 years']","['oral iron supplementation', 'elemental iron as ferrous sulfate (the standard, commonly used form), 18\u2009mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo']","['anaemia prevalence', 'potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage', 'ferritin concentrations']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1721498', 'cui_str': 'ferrous bisglycinate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.77336,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","[{'ForeName': 'Jordie Aj', 'Initials': 'JA', 'LastName': 'Fischer', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lulu X', 'Initials': 'LX', 'LastName': 'Pei', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Goldfarb', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Department of Biostatistics, Women's Health Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International Cambodia, Phnom Penh, British Columbia, Cambodia.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada Crystal.Karakochuk@ubc.ca.'}]",BMJ open,['10.1136/bmjopen-2020-037232']
1648,32815101,Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium™ video laryngoscope use: a randomized-controlled trial.,"PURPOSE


Intubation-associated trauma with the GlideScope is rare, but when it occurs, it is likely due to advancing the endotracheal tube (ETT) blindly between the direct view of the oropharynx and the video view of the glottis. It is also occasionally difficult to advance the ETT to the glottic aperture despite a good view of the glottis on the monitor. One technique to potentially address both issues is to introduce the ETT en bloc with the GlideScope, thus visualizing the ETT tip throughout its entire path. We hypothesized that this en bloc technique could be faster and potentially easier than the standard technique.
METHODS


Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery were randomly allocated to intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique. A three-dimensional printed clip was utilized to secure the ETT to the GlideScope during en bloc insertion. The primary outcome was time to intubation, defined from mask removal to first end-tidal carbon dioxide detection, recorded by a blinded observer. Secondary outcomes were subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding).
RESULTS


The median [interquartile range (IQR)] intubation time was 36 [31-42] sec with the en bloc technique vs 41 [37-50] sec with the standard technique (difference in medians, 5 sec; 95% confidence interval [CI], 2 to 11; P = 0.008). The median [IQR] ease of intubation VAS was 11 [9-21] mm with the en bloc technique, and 15 [11-24] mm with the standard technique (difference in medians, 4 mm; 95% CI, -2 to 8; P = 0.19). Laryngoscopic grade and number of intubation attempts were similar between the groups; there was no oropharyngeal trauma noted.
CONCLUSION


In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02787629); registered 1 June 2016.",2020,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
",['Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery'],"['intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique', 'Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium']","['time to intubation, defined from mask removal to first end-tidal carbon dioxide detection', 'Laryngoscopic grade and number of intubation attempts', 'median [IQR] ease of intubation VAS', 'subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding', 'median [interquartile range (IQR', 'intubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",50.0,0.120902,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Turkstra', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Turkstra', 'Affiliation': 'Department of Mechanical Engineering, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Pavlosky', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01778-2']
1649,32816215,Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials.,"BACKGROUND


Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Creatine kinase (CK) levels and CK-related adverse events (AEs) in tofacitinib-treated patients with UC were evaluated.
METHODS


Data were analyzed for three UC cohorts: Induction (phase 2 and 3 induction studies); Maintenance (phase 3 maintenance study); Overall [patients who received tofacitinib 5 or 10 mg twice daily (b.d.) in phase 2, phase 3, or open-label, long-term extension studies; data at November 2017]. Clinical trial data for tofacitinib-treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis are presented for contextualization.
RESULTS


Week 8 mean change from baseline CK with tofacitinib 10 mg b.d. induction therapy was 91.1 U/L (95% CI, 48.1-134.1) versus 19.2 U/L (8.5-29.9) with placebo. Among patients completing induction with 10 mg b.d. and re-randomized to 52 weeks of maintenance therapy, mean increases from induction baseline to the end of maintenance were 35.9 (8.1-63.7), 90.3 (51.9-128.7), and 115.6 U/L (91.6-139.7), with placebo, 5 and 10 mg b.d., respectively. The incidence rate (unique patients with events per 100 patient-years) for AEs of CK elevation in the tofacitinib-treated UC Overall cohort was 6.6 versus 2.2, 6.5, and 3.7 for tofacitinib-treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis, respectively. No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
CONCLUSIONS


In patients with UC, CK elevations with tofacitinib appeared reversible and not associated with clinically significant AEs. UC findings were consistent with tofacitinib use in other inflammatory diseases.
TRIAL REGISTRATION


NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612; NCT01262118; NCT01484561; NCT00147498; NCT00413660; NCT00550446; NCT00603512; NCT00687193; NCT01059864; NCT01164579; NCT00976599; NCT01359150; NCT02147587; NCT00960440; NCT00847613; NCT00814307; NCT00856544; NCT00853385; NCT01039688; NCT02187055; NCT00413699; NCT00661661; NCT01710046; NCT00678210; NCT01276639; NCT01309737; NCT01241591; NCT01186744; NCT01163253; NCT01877668; NCT01882439; NCT01976364.",2020,"No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
","['Treated Patients with Ulcerative Colitis', 'Data were analyzed for three UC cohorts: Induction (phase 2 and 3 induction studies); Maintenance (phase 3 maintenance study', 'treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis']","['Tofacitinib', 'tofacitinib', 'placebo']","['CK elevations', 'incidence rate', 'Creatine kinase (CK) levels and CK-related adverse events (AEs', 'CK elevation', 'CK elevation or AEs of myopathy']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}]",,0.408836,"No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Department of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada. rpanacci@ucalgary.ca.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Isaacs', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lea Ann', 'Initials': 'LA', 'LastName': 'Chen', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Marren', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06560-4']
1650,32818946,Greater Attendance at a Community Weight Loss Programme over the First 12 Weeks Predicts Weight Loss at 2 Years.,"BACKGROUND


There is considerable heterogeneity in long-term weight loss among people referred to obesity treatment programmes. It is unclear whether attendance at face-to-face sessions in the early weeks of the programme is an independent predictor of long-term success.
OBJECTIVE


To investigate whether frequency of attendance at a community weight loss programme over the first 12 weeks is associated with long-term weight change.
METHODS


Participants were randomised to receive brief support only (control, n = 211), or a weight loss programme for 12 weeks (n = 530) or 52 weeks (n = 528). This study included participants with data on session attendance over the first 12 weeks (n = 889) compared to the control group. The association between attendance (continuously) and weight loss was explored using a linear model. A multi-level mixed-effects linear model was used to investigate whether attendance (categorised as 0, 1, 2-5, 6-9, and 10-12 sessions) was associated with weight loss at 3, 12, and 24 months compared to the control.
RESULTS


For every session attended in the first 12 weeks, the average weight loss was -0.259 kg/session at 24 months (p = 0.005). Analysis by attendance group found only those attending 10-12 sessions had significantly greater weight loss (-7.5 kg [95% CI -8.1 to -6.9] at 12 months; -4.7 kg [95% CI -5.3 to -4.1] at 24 months) compared to the control group (-3.4 [95% CI -4.5 to -2.4] at 12 months, -2.5 [95% CI -3.5 to -1.5] at 24 months). Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
CONCLUSIONS


Greater attendance at a community weight loss programme in the first 12 weeks is associated with enhanced weight loss up to 24 months. Regular attendance at a programme could be used as a criterion for continued provision of weight loss services to maximise the cost-effectiveness of interventions.",2020,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","['Participants', 'participants with data on session attendance over the first 12 weeks (n = 889', 'people referred to obesity treatment programmes']",['weight loss programme'],"['weight loss', 'enhanced weight loss', 'attendance (continuously) and weight loss', 'average weight loss']","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0377466,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, carmen.piernas-sanchez@phc.ox.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacLean', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Woolston', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000509131']
1651,32818949,Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial.,"BACKGROUND


Intrauterine infection and/or inflammation (Triple I) is an important cause of preterm birth (PTB) and adverse newborn outcomes. N-acetylcysteine (NAC) is a Food and Drug Administration (FDA)-approved drug safely administered to pregnant women with acetaminophen toxicity.
METHODS


We conducted a single-center, quadruple-blind, placebo-controlled trial of pregnant women with impending PTB due to confirmed Triple I. Participants (n = 67) were randomized to an intravenous infusion of NAC or placebo mimicking the FDA-approved regimen. Outcomes included clinical measures and mechanistic biomarkers.
RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34). Fewer NAC-exposed newborns developed two or more prematurity-related severe morbidities [NAC: 21% vs. placebo: 47%, relative risk, 0.45; 95% confidence interval (CI) 0.21-0.95] with the strongest protection afforded against bronchopulmonary dysplasia (BPD, NAC: 3% vs. placebo: 32%, relative risk, 0.10; 95% CI: 0.01-0.73). These effects were independent of gestational age, birth weight, sex, or race. Umbilical cord plasma NAC concentration correlated directly with cysteine, but not with plasma or whole blood glutathione. NAC reduced the placental expression of histone deacetylase-2, suggesting that epigenetic mechanisms may be involved.
CONCLUSIONS


These data provide support for larger studies of intrapartum NAC to reduce prematurity-related morbidity.
IMPACT


In this randomized clinical trial of 65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight. Administration of NAC in amniocentesis-confirmed Triple I resulted in a remarkably lower incidence of BPD. As prior studies have not shown a benefit of postnatal NAC in ventilated infants, our trial highlights the critical antenatal timing of NAC administration. Repurposing of NAC for intrapartum administration should be explored in larger clinical trials as a strategy to improve prematurity-related outcomes and decrease the incidence of BPD.",2020,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","['premature infants with intra-amniotic infection and inflammation (Triple I', '65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight', 'pregnant women with impending PTB due to confirmed Triple I. Participants (n\u2009=\u200967', 'women with idiopathic preterm birth (iPTB, a, b) absent', 'Thirteen patients who were ineligible for the trial based on negative assessment for Triple I contributed placental samples as reference for immunohistochemistry experiments', 'pregnant women with acetaminophen toxicity']","['NAC or placebo', 'Antenatal N-acetylcysteine', 'N-acetylcysteine (NAC', 'placebo (c, d) or N-acetylcysteine infusion (e, f', 'Triple I or PTB', 'NAC', 'immunohistochemical staining for histone deacetylase-2 (HDAC2', 'placebo']","['status at birth and required less intensive resuscitation', 'Umbilical cord plasma NAC concentration', 'BPD', 'clinical measures and mechanistic biomarkers', 'placental expression of histone deacetylase-2', 'prematurity-related severe morbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0237963', 'cui_str': 'Poisoning caused by acetaminophen'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0404413', 'cui_str': 'Placental expression'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",65.0,0.55222,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","[{'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA. csb01@uic.edu.'}, {'ForeName': 'Mert Ozan', 'Initials': 'MO', 'LastName': 'Bahtiyar', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Guomao', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelghany', 'Affiliation': 'Clinical Department of Pharmacy, Yale New Haven Hospital, New Haven, CT, 06510, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Sonya Abdel', 'Initials': 'SA', 'LastName': 'Razeq', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Antonette T', 'Initials': 'AT', 'LastName': 'Dulay', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Lipkind', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Saya', 'Initials': 'S', 'LastName': 'Mieth', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}]",Pediatric research,['10.1038/s41390-020-01106-w']
1652,32818953,Navigation aid for blind persons by visual-to-auditory sensory substitution: A pilot study.,"PURPOSE


In this study, we investigate to what degree augmented reality technology can be used to create and evaluate a visual-to-auditory sensory substitution device to improve the performance of blind persons in navigation and recognition tasks.
METHODS


A sensory substitution algorithm that translates 3D visual information into audio feedback was designed. This algorithm was integrated in an augmented reality based mobile phone application. Using the mobile device as sensory substitution device, a study with blind participants (n = 7) was performed. The participants navigated through pseudo-randomized obstacle courses using either the sensory substitution device, a white cane or a combination of both. In a second task, virtual 3D objects and structures had to be identified by the participants using the same sensory substitution device.
RESULTS


The realized application for mobile devices enabled participants to complete the navigation and object recognition tasks in an experimental environment already within the first trials without previous training. This demonstrates the general feasibility and low entry barrier of the designed sensory substitution algorithm. In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",2020,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",[],"['visual-to-auditory sensory substitution', 'sensory substitution device, a white cane or a combination of both']",['navigation'],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]",[],,0.0374328,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neugebauer', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rifai', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Getzlaff', 'Affiliation': 'Institute for Applied Physics, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wahl', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237344']
1653,32819928,ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.,"INTRODUCTION


Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
METHODS AND ANALYSIS


We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.
ETHICS AND DISSEMINATION


This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).",2020,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","['infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD', 'infants at risk of autism spectrum disorder', 'Autism spectrum disorder (ASD', '66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT']","['ENACT (ENvironmental enrichment', 'innovative intervention', 'ENACT', 'social reciprocity intervention']","['parent-infant interaction, parental mental health, infant development and early ASD markers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.264507,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGlade', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kavindri', 'Initials': 'K', 'LastName': 'Kulasinghe', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Honey', 'Initials': 'H', 'LastName': 'Heussler', 'Affiliation': 'Mater Medical Research Institute, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034315']
1654,32819929,"Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded, randomised, parallel-controlled study protocol in China.","INTRODUCTION


This clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).
METHODS AND ANALYSIS


A randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.
ETHICS AND DISSEMINATION


The Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.
TRIAL REGISTRATION NUMBER


ChiCTR1900025013.",2020,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","['patients with rheumatoid arthritis (RA', 'Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty', 'total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded']","['tranexamic acid (TXA', 'tranexamic acid', 'TXA']","['blood loss, maximum haemoglobin drop and transfusion rate', 'knee function and complications', 'perioperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.222455,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","[{'ForeName': 'Bing-Xin', 'Initials': 'BX', 'LastName': 'Kang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chen-Xin', 'Initials': 'CX', 'LastName': 'Gao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Sun', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Ma', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Zhai', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lian-Bo', 'Initials': 'LB', 'LastName': 'Xiao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China 13701888178@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034431']
1655,32819927,"Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).","OBJECTIVES


To compare the effectiveness of oral versus intramuscular (IM) vitamin B 12  (VB12) in patients aged ≥65 years with VB12 deficiency.
DESIGN


Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).
PARTICIPANTS


283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.
INTERVENTIONS


The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52.
MAIN OUTCOMES


Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.
RESULTS


The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B 12  levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B 12  levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.
CONCLUSIONS


Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.
TRIAL REGISTRATION NUMBERS


NCT01476007; EUDRACT (2010-024129-20).",2020,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"['patients aged ≥65 years with VB12 deficiency', '22 primary healthcare centres in Madrid (Spain', '283 patients ≥65 years with VB12 deficiency']","['vitamin B12', 'oral versus intramuscular (IM) vitamin B 12  (VB12']","['normal B 12  levels', 'Quality of life and adverse effects', 'Serum VB12 concentration normalisation', 'symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",22.0,0.335499,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz-Cuesta', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Escortell-Mayor', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Cura-Gonzalez', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain isabel.cura@salud.madrid.org.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Martin-Fernandez', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Riesgo-Fuertes', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Garrido-Elustondo', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose Enrique', 'Initials': 'JE', 'LastName': 'Mariño-Suárez', 'Affiliation': 'Healthcare Centre El Greco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Álvarez-Villalba', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gómez-Gascón', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'González-García', 'Affiliation': 'Healthcare Centre Barajas, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'González-Escobar', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Vargas-Machuca Cabañero', 'Affiliation': 'Healthcare Centre Guayaba, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Noguerol-Álvarez', 'Affiliation': 'Healthcare Centre Cuzco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'García de Blas-González', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Baños-Morras', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Díaz-Laso', 'Affiliation': 'Healthcare Centre Fuentelarreina, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Caballero-Ramírez', 'Affiliation': 'Healthcare Centre Juncal, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Herrero de-Dios', 'Affiliation': 'Healthcare Centre Miguel de Cervantes, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fernández-García', 'Affiliation': 'Healthcare Centre Santa Isabel, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Herrero-Hernández', 'Affiliation': 'Healthcare Centre Lavapiés, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Pose-García', 'Affiliation': 'Healthcare Centre Mendiguchía Carriche, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Sevillano-Palmero', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Mateo-Ruiz', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Medina-Bustillo', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Aguilar-Jiménez', 'Affiliation': 'UICEC Hospital Ramón y Cajal. Plataforma SCReN, Hospital Ramón y Cajal; Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033687']
1656,32819944,"Protocol of a multicenter, single-blind, randomised, parallel controlled feeding trial evaluating the effect of a Chinese Healthy Heart (CHH) diet in lowering blood pressure and other cardiovascular risk factors.","INTRODUCTION


Unhealthy diet has been identified as the number one attributor of total mortality in China, accounting for more than 20% of total deaths. Although the Dietary Approach to Stop Hypertension (DASH) and Mediterranean diets have been proven beneficial in managing cardiovascular risk factors in Western countries, whether healthy diets with similar cardiovascular benefits can be developed that are consistent with Chinese food culture remains unknown.
METHODS/DESIGN


The Diet, ExerCIse and CarDiovascular hEalth (DECIDE)-Diet trial is a multicentre, single-blind, randomised controlled feeding trial to evaluate the effect of the Chinese Healthy Heart (CHH) diet, in comparison with the Chinese usual diet, in lowering cardiovascular risk factors among community residents with the increased cardiovascular risk. A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu. After 1 week of run-in period with local usual diet, the compliant participants will be randomised to the intervention group with the CHH diet or the control group with the usual local diet, on a 1:1 ratio, for 4 weeks. Body weight of study participants will be maintained during the entire study period. The primary outcome is the change in SBP from the baseline to the end of the study. DECIDE-Diet trial will be the first randomised controlled feeding trial to evaluate the effect of a CHH diet in lowering cardiovascular risk factors. This trial will provide compelling evidence on the CHH diet in effect of improving cardiovascular health among Chinese food consumers all around the world.
ETHICS AND DISSEMINATION


This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-18094). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.
TRAIL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03882645); Pre-results.",2020,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","['community residents with the increased cardiovascular risk', '360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159\u2009mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu']","['Chinese Healthy Heart (CHH) diet', 'CHH diet or the control group with the usual local diet', 'CHH diet']","['blood pressure and other cardiovascular risk factors', 'change in SBP', 'Diet, ExerCIse and CarDiovascular hEalth']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",360.0,0.111837,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","[{'ForeName': 'Wuxiang', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China pucri_wangyf1225@bjmu.edu.cn.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Clinical Nutrition Center, Huadong Hospital affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Nutrition, Food Safety and Toxicology, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huilian', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhenquan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'College of Tourism and Culinary Science, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Nephrology Division, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Society of Health Risk Assessment & Control, Chinese Preventive Medicine Association, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Food Safety Risk Assessment of Ministry of Health, National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-036394']
1657,32828349,Effectiveness of nurses training in routine screening of violence against women with mental illness: A randomized controlled trail.,"BACKGROUND


Globally, people with mental illness are highly vulnerable to various forms of abuse. Yet, research on routine screening of violence by mental health professionals is limited.
AIM


The aim of this study was to evaluate the impact of training on nurses' attitudes towards routine screening and confidence in implementing routine screening of violence among women with mental illness.
METHODS


A randomized controlled trial design was adopted for the present study. The participants of this study were 68 nurses randomly assigned to either experimental or control group (34 in each group). The experimental group was provided eight interactive sessions based on a Nursing Module on abuse among women with mental illness. The assessments were done in both groups at baseline, after the intervention, at three months and at six months. All assessments were self-rated questionnaires to assess nurses' attitudes and confidence in implementing routine screening of violence attitudes.
RESULTS


The experimental group showed a statistically significant improvement in the attitudes and confidence in implementing routine screening of abuse in women with mental illness (p < 0.05) than the control group. Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
CONCLUSION


This study concluded that training based on a nursing module improved nurses' attitudes and confidence to conduct routine screening of violence among women with mental illness. However, further studies are necessary to clarify whether the training is effective in implementing in nursing practice.",2020,"Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
","['people with mental illness', 'on abuse among women with mental illness', 'routine screening of violence against women with mental illness', 'women with mental illness']","['interactive sessions based on a Nursing Module', 'nurses training']","['attitudes and confidence in implementing routine screening of abuse in women with mental illness', 'attitude and confidence in implementing routine screening of abuse']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",68.0,0.0776145,"Repeated measures of analysis also revealed statistically significant differences related to attitude and confidence in implementing routine screening of abuse between the groups and within the experimental group at different time points of assessment (p < 0.001).
","[{'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Poreddi', 'Affiliation': 'College of Nursing, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India. Electronic address: pvijayalakshmireddy@gmail.com.'}, {'ForeName': 'Sailaxmi', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Department of Nursing, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}, {'ForeName': 'Sai Nikhil', 'Initials': 'SN', 'LastName': 'Reddy', 'Affiliation': 'Bangalore Medical College and Research Institute, Bangalore, India.'}, {'ForeName': 'Marimuthu', 'Initials': 'M', 'LastName': 'Palaniappan', 'Affiliation': 'Department of Bio-statistics, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'BadaMath', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (Institute of National Importance), Bangalore, India.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.05.003']
1658,32828351,"Effects of psychological intervention for Korean infertile women under In Vitro Fertilization on infertility stress, depression, intimacy, sexual satisfaction and fatigue.","This quasi-experimental study with a nonequivalent control group pretest-posttest design was conducted to evaluate the effects of a psychological intervention program for 50 women with infertility (experimental group: 26, control group: 24) utilizing assisted reproductive technology. The experimental group received six four-hour sessions of intervention, with outcomes measured at baseline and four weeks post-intervention. The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001). Thus, the program can alleviate depression and fatigue. Further, psychological intervention centered on the marital and personal dimensions may improve marital intimacy and sexual satisfaction.",2020,"The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001).","['Korean infertile women under', '50 women with infertility (experimental group: 26, control group: 24']","['psychological intervention program', 'psychological intervention', 'utilizing assisted reproductive technology']","['marital intimacy and sexual satisfaction', 'sexual satisfaction', 'infertility stress, depression, intimacy, sexual satisfaction and fatigue', 'marital intimacy', 'fatigue', 'depression']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50.0,0.0201846,"The experimental group demonstrated significant improvements in marital intimacy (z = 6.528, p < .001) and sexual satisfaction (z = 3.148, p = .003) and significant reductions in depression (z = -4.850, p < .001) and fatigue (z = -4.597, p < .001).","[{'ForeName': 'Miok', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dankook University, Dandae-ro 119, Cheonan 31116, Chungnam, South Korea. Electronic address: aprilsea@hanmail.net.'}, {'ForeName': 'So-Hyun', 'Initials': 'SH', 'LastName': 'Moon', 'Affiliation': 'Department of Nursing, College of Medicine, Chosun University, Pilmundae-ro 309, Dong-gu, Gwangju 61452, South Korea. Electronic address: shmoon@chosun.ac.kr.'}, {'ForeName': 'Jee-Ean', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': ""Department of Early Childhood Education, Baewha Women's University, Pirundaero 1-gil 34, Jongno-gu, Seoul 03039, South Korea. Electronic address: 10105@baewha.ac.kr.""}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.05.001']
1659,32828358,The effect of behavioral parent training on sleep problems of school-age children with ADHD: A parallel randomized controlled trial.,"OBJECTIVE


The aim of this study was to examine the effect of behavioral parental training (BPT) on sleep problems in children diagnosed with ADHD.
METHODS


This parallel randomized controlled trial was conducted in a psychiatric clinic in an urban area of Iran. Participants of this study were 58 school-age children who were diagnosed with ADHD, were receiving methylphenidate and had at least one problem in sleeping. They were randomly assigned into BPT or control groups. Participants' parents in the BPT group underwent a 5-week behavioral intervention program. Data were collected at baseline, immediately after the intervention, and two months after the intervention. Data were analyzed using Chi-square, Fisher's exact test, independent sample t-test, and repeated measure ANOVA test via the SPSS software.
RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03). Also, the findings showed a significant decline in total sleep problems in the intervention group compared to the control group over time (p = 0.01).
CONCLUSION


The results suggest that BPT could be an effective method in improving sleep problems of school-age children diagnosed with ADHD undergoing methylphenidate treatment.",2020,"RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03).","['children diagnosed with ADHD', 'Participants of this study were 58 school-age children who were diagnosed with ADHD, were receiving methylphenidate and had at least one problem in sleeping', 'sleep problems of school-age children with ADHD', ""Participants' parents in the BPT group underwent a"", 'school-age children diagnosed with ADHD undergoing methylphenidate treatment', 'psychiatric clinic in an urban area of Iran']","['behavioral parent training', '5-week behavioral intervention program', 'BPT', 'behavioral parental training (BPT']","['total sleep problems', 'sleep problems', 'total sleep scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",58.0,0.113286,"RESULTS


Children in the intervention group experienced a significant improvement in total sleep scores two months after the intervention compared to the control group (p = 0.03).","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Mehri', 'Affiliation': 'Department of Paediatric Nursing, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Minoo Mitra', 'Initials': 'MM', 'LastName': 'Chehrzad', 'Affiliation': 'Department of Paediatric Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: maleki@shmu.ac.ir.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Dianatinasab', 'Affiliation': 'Department of Epidemiology, Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kousha', 'Affiliation': 'Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assari', 'Affiliation': 'Department of Family Medicine, Charles R Drew University of Medicine and science, Los Angeles, CA, USA.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.04.001']
1660,32807749,"CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.","Background/Aims


CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released.
Methods


We conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using wireless motility capsule transit testing at pre-treatment and end-of-treatment. The primary endpoint was change in CTT.
Results


Forty subjects (20 CSP01, 11 CMC, 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group ( P  = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 ( P  = 0.025 compared to placebo), 919 minutes for CMC ( P  = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events.
Conclusion


CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.",2020,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","['Patients With Chronic Idiopathic Constipation', 'Forty subjects (20 CSP01; 11 CMC; 9 placebo) were enrolled and 38 completed the study', 'patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either']","['CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo', 'CSP01, a Novel Superabsorbent Hydrogel', 'placebocontrolled', 'placebo']","['CTT', 'change in CTT', 'mean CTT', 'back pain', 'Colonic Transit Time', 'colonic transit time (CTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",,0.296183,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Staller', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Barshop', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vélez', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chiquette', 'Affiliation': 'Gelesis Inc, Boston, MA, USA.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Kuo', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20001']
1661,32813829,Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazil's Unified Public Health System (SUS).,"Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89).",2020,"In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol.","['patients with symptomatic single-vessel coronary artery disease', 'SUS patients with single-vessel coronary artery disease']","['DES or BMS', 'percutaneous coronary intervention (PCI', 'drug-eluting stents (DESs), compared with bare-metal stents (BMSs', 'Drug-Eluting Stents']","['death', 'TLR', 'stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness', 'ISR', 'incremental cost-effectiveness ratio (ICER', 'cost of the procedure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0581374', 'cui_str': 'Single coronary vessel disease'}, {'cui': 'C0574518', 'cui_str': 'Susu language'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0721266,"In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol.","[{'ForeName': 'João Addison', 'Initials': 'JA', 'LastName': 'Pessoa', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Esmeralci', 'Initials': 'E', 'LastName': 'Ferreira', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Denizar Viana', 'Initials': 'DV', 'LastName': 'Araújo', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Edirley', 'Initials': 'E', 'LastName': 'Maia', 'Affiliation': 'Hospital São Lucas, Nova Friburgo, RJ, Brasil.'}, {'ForeName': 'Felipe Souza Maia da', 'Initials': 'FSMD', 'LastName': 'Silva', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Maurício Salles de', 'Initials': 'MS', 'LastName': 'Oliveira', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Denilson Campos de', 'Initials': 'DC', 'LastName': 'Albuquerque', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180292']
1662,32820324,Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial.,"AIMS


The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes.
METHODS AND RESULTS


Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA-. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA- (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA- required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
CONCLUSION


This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure.",2020,"Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
","['One hundred patients were randomized in OPERA+ and 100 patients in OPERA', 'Two hundred patients']","['radiofrequency ablation (RFA) of atrial fibrillation (AF', 'Radiofrequency Ablation of Atrial Fibrillation (OPERA', 'OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25\u2009W at the posterior wall without an oesophageal probe']","['endoscopically diagnosed oesophageal lesions (EDEL', 'average EDEL size', 'probability of developing EDEL', 'Cumulative AF recurrence', 'peak temperature', 'incidence of oesophageal lesions']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.044547,"Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schoene', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Arya', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Grashoff', 'Affiliation': 'Leipzig Heart Institute GmbH, Leipzig, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Knopp', 'Affiliation': 'Helios Klinikum Leisnig, Leisnig, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'KMG Klinikum Güstrow, Güstrow, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lerche', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'König', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hilbert', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kircher', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Bertagnolli', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Dinov', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Halm', 'Affiliation': 'Parkkrankenhaus Leipzig, Leipzig, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zachäus', 'Affiliation': 'Parkkrankenhaus Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Sommer', 'Affiliation': 'Herz- und Diabetes Zentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa209']
1663,32817078,Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation.,"PURPOSE


For multiple myeloma, high-dose chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT) at 10-15 mg/day is considered standard of care. However, dose reductions due to side effects are common and median LenMT doses achieved over time may remain lower. Dose response during LenMT has never been investigated.
PATIENTS AND METHODS


In a multicenter, randomized, open-label trial, patients with multiple myeloma after ASCT and high-dose lenalidomide consolidation therapy (CT) at 25 mg/day were randomized to receive LenMT at either 25 or 5 mg/day. Primary endpoint was progression-free survival (PFS).
RESULTS


Ninety-four patients (median age, 58 years) were randomized to either arm, with 22% having International Staging System (ISS) stage 3 and 22% being in complete remission (CR). After median follow-up of 46.7 months, median doses of 14.5 and 5 mg/day were achieved in the two arms; 53% of dose reductions occurring during CT. In the high- and the low-dose arm, median PFS was 44.8 and 33.0 months (HR, 0.65; 95% CI, 0.44-0.97;  P  = 0.032), 36% and 23% of patients had stringent CR as best response ( P  = 0.08), and 4-year OS was 79% and 67% ( P  = 0.16), respectively. Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose adjustments. SPM incidence and quality-of-life (QoL) scores in both arms were similar.
CONCLUSIONS


LenMT dose correlated with efficacy and toxicity. High rates of dose reductions during CT argue against a high starting dose. However, continuous up- and down-titration for each patient to the current maximum tolerated dose is prudent.",2020,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","['Ninety-four patients (median age 58 years', 'multiple myeloma after autologous blood stem cell transplantation']","['lenalidomide maintenance therapy', 'ASCT and high-dose lenalidomide consolidation therapy (CT', 'chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT', 'LenMT']","['Hematologic toxicity, grade ≥3 neutropenia, and infections', '4-year OS', 'Efficacy and tolerability', 'SPM incidence and QoL scores', 'efficacy and toxicity', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",94.0,0.163084,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Fenk', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany. fenk@med.uni-duesseldorf.de.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marienhospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heinsch', 'Affiliation': 'Helios St. Johannis Hospital Duisburg, Duisburg, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Rummel', 'Affiliation': 'Justus-Liebig University Giessen, Giessen, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kroger', 'Affiliation': 'University Cancer Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Boquoi', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Gerrlich', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Baier', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Liesenjohann', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ingrida', 'Initials': 'I', 'LastName': 'Savickaite', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'University Hospital Heidelberg and National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Aul', 'Affiliation': 'Helios St. Johannis Hospital Duisburg, Duisburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Strapatsas', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dienst', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kondakci', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Kobbe', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0841']
1664,32817266,Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.,"OBJECTIVES


To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
METHODS


Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
RESULTS


From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group;  P  =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group;  P  = .88). Infant growth in both groups was suboptimal (the mean weight-for-age  z  scores were -1.1 in the intervention group and -1.2 in the control group;  P  = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group;  P  < .001).
CONCLUSIONS


When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.",2020,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","['Congenital Heart Disease', 'parents of infants recovering from cardiac surgery and their infants', 'From 2012 to 2016', '219 parent-infant dyads were enrolled; 109', 'Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers', 'infants discharged from the hospital after cardiac surgery for congenital heart disease']","['telehealth home monitoring program (REACH), layered on usual care']","['readmitted to the hospital', 'Suboptimal infant growth and hospital readmissions', 'total Parenting Stress Index', 'posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores', 'Infant growth', 'parenting stress', 'mean Ulm Quality of Life Inventory']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0471754,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff Cooper', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania; medoff@upenn.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Marino', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Fleck', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amy Jo', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Golfenshtein', 'Affiliation': 'Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': 'Division of Cardiology, Department of Pediatrics and.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Costello', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Department of Statistics, College of Science, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; and.'}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'Department of Anesthesia and Critical Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pediatrics,['10.1542/peds.2020-0531']
1665,32826784,Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.,"BACKGROUND


Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP).
OBJECTIVE


Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care.
METHODS


Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon.
RESULTS


Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was ""dominant"" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost.
DISCUSSION/CONCLUSIONS


Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.",2020,Negligible differences in health care costs were found between groups.,"['Veterans', 'military veterans with cLBP', 'Participants (n=150', 'persons with chronic low back pain (cLBP']",[],"['Roland-Morris Disability Questionnaire', 'Health care costs', 'pain and disability', 'EQ-5D scale', 'health care costs', 'Quality-adjusted life years (QALYs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",150.0,0.0429254,Negligible differences in health care costs were found between groups.,"[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Richard', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Tally', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}]",Medical care,['10.1097/MLR.0000000000001356']
1666,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and Design of a Cluster-Randomized Trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi. FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0 mmHg difference in systolic BP at a 0.05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the US.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
1667,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1668,32829526,"Intradialytic isometric handgrip exercise does not cause hemodynamic instability: A randomized, cross-over, pilot study.","Hemodialysis (HD) patients experience hemodynamic instability and intradialytic exercise seems to attenuate it. This study aimed to verify the acute hemodynamic response to different intradialytic handgrip exercise intensities in HD patients. In a randomized, cross-over, experimental pilot study, eight patients completed two experimental sessions and one control in random order: (a) regular HD; (b) low-intensity isometric handgrip exercise; and (c) moderate-intensity isometric handgrip exercise. BP and heart rate variability were recorded immediately before and every 15 minutes. Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (P > .05). The systolic BP and double product significantly increased immediately after the moderate-intensity protocol (122.0 ± 15.9 vs 131.3 ± 19.8, P < .05; 9094.7 ± 1705.7 vs 9783.0 ± 1947.9, P < .05, respectively) but returned to the pre-exercise values 10 minutes later. We conclude that intradialytic isometric handgrip exercise does not induce hemodynamic instability at low and moderate intensities.",2020,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","['Hemodialysis patients experience hemodynamic instability', 'hemodialysis patients']","['Isometric handgrip exercise protocols', 'Intradialytic Isometric Handgrip Exercise', 'intradialytic handgrip exercise intensities', 'intradialytic isometric handgrip exercise', 'regular hemodialysis, ii) low-intensity isometric handgrip exercise, and ii) moderate-intensity isometric handgrip exercise', 'Intradialytic exercise']","['hemodynamic instability', 'hemodynamic stability', 'systolic blood pressure', 'Cause Hemodynamic Instability', 'Blood pressure and heart rate variability']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",8.0,0.0224199,"Isometric handgrip exercise protocols, regardless of the intensity, did not lead to significant changes in hemodynamic stability, nor when compared to the control condition (p>0.05).","[{'ForeName': 'Heitor S', 'Initials': 'HS', 'LastName': 'Ribeiro', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Vinícius A', 'Initials': 'VA', 'LastName': 'Cunha', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Baiao', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Lucas S', 'Initials': 'LS', 'LastName': 'Almeida', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Gustavo Í', 'Initials': 'GÍ', 'LastName': 'Dourado', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Helton L', 'Initials': 'HL', 'LastName': 'Carvalho', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'Marvery P', 'Initials': 'MP', 'LastName': 'Duarte', 'Affiliation': 'Faculty of Physical Education, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Inda-Filho', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}, {'ForeName': 'João L', 'Initials': 'JL', 'LastName': 'Viana', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University Institute of Maia (ISMAI), Porto, Portugal.'}, {'ForeName': 'Otávio T', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Faculty of Health Science, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Aparecido P', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'Interdisciplinary Research Department, University Center ICESP, Brasília, Brazil.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13581']
1669,32815416,"Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial.","BACKGROUND


Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care.
METHODS


An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death.
CONCLUSION


Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.",2020,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","['patients hospitalized with COVID-19 compared to usual care', 'patients hospitalized with COVID-19']","['ATTACC', 'low-molecular-weight heparin or unfractionated heparin']","['mechanical ventilation and/or death', 'worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death', 'Complications of COVID-19']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",,0.254399,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","[{'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Houston', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ewan C', 'Initials': 'EC', 'LastName': 'Goligher', 'Affiliation': 'Toronto General Hospital Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jean-Phillippe', 'Initials': 'JP', 'LastName': 'Galanaud', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Gross', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute, Department of Medicine, McMaster University & Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital/Lady Davis Institute, Division of Internal Medicine, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Department of Surgery, St Michael's Hospital and the University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Centre at the Li Ka Shing Knowledge Institute, St. Michael's Hospital and Departments of Medicine, Surgery, and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Escobedo', 'Affiliation': 'Medical Research Unit on Clinical Epidemiology, Mexican Social Security Institute, Mexico City, Mexico.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Ozmosis Research Inc., Toronto, ON, Canada.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'de Brouwer', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}]","Clinical trials (London, England)",['10.1177/1740774520943846']
1670,32817701,Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes.,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources.",2020,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","['women with GDM', 'Chinese women with gestational diabetes (GDM', 'Chinese women with gestational diabetes', 'pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective']","['NNT', 'shared care program (SC', 'lifestyle intervention using a 3-tier shared care approach', 'individualized dietary advice and physical activity counseling program']","['cost-effectiveness', 'cost of preventing a case of macrosomia/LGA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}]",,0.0234859,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","[{'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shao', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Huiguang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity and The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, Hong Kong SAR, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States of America.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",PloS one,['10.1371/journal.pone.0237738']
1671,32817703,Effect of ventilation rate on recovery after cardiac arrest in a pediatric animal model.,"AIMS


To assess the impact of two different respiratory rates in hemodynamic, perfusion and ventilation parameters in a pediatric animal model of cardiac arrest (CA).
METHODS


An experimental randomized controlled trial was carried out in 50 piglets under asphyxial CA. After ROSC, they were randomized into two groups: 20 and 30 respirations per minute (rpm). Hemodynamic, perfusion and ventilation parameters were measured 10 minutes after asphyxia, just before ROSC and at 5, 15, 30 and 60 minutes after ROSC. Independent medians test, Kruskal-Wallis test and χ2 test, were used to compare continuous and categorical variables, respectively. Spearman's Rho was used to assess correlation between continuous variables. A p-value <0.05 was considered significant.
RESULTS


Arterial partial pressure of carbon dioxide (PaCO2) was significantly lower in the 30 rpm group after 15 minutes (41 vs. 54.5 mmHg, p <0.01), 30 minutes (39.5 vs. 51 mmHg, p < 0.01) and 60 minutes (36.5 vs. 48 mmHg, p = 0.02) of ROSC. The percentage of normoventilated subjects (PaCO2 30-50 mmHg) was significantly higher in the 30 rpm group throughout the experiment. pH normalization occurred faster in the 30 rpm group with significant differences at 60 minutes (7.40 vs. 7.34, p = 0.02). Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
CONCLUSIONS


This animal model of asphyxial CA shows that a respiratory rate of 30 rpm is more effective to reach normoventilation than 20 rpm in piglets after ROSC. This ventilation strategy seems to be safe, as it does not cause hyperventilation and does not affect hemodynamics or cerebral tissue perfusion.",2020,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
",['50 piglets under asphyxial CA'],['ventilation rate'],"['Arterial partial pressure of carbon dioxide (PaCO2', 'Lactic acid levels', 'pH normalization', 'Hemodynamic, perfusion and ventilation parameters']","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.046131,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Arias', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Domenech', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horcajo', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Nocete', 'Affiliation': 'Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Sarah Nicole', 'Initials': 'SN', 'LastName': 'Fernández', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0237736']
1672,32819447,"Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk.","BACKGROUND


Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).
METHODS


This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10 -5  sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.
RESULTS


After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.
CONCLUSION


These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.",2020,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","['patients with relapsed or refractory MM (RRMM', 'Multiple myeloma (MM) patients with high cytogenetic risk']","['Daratumumab, bortezomib, and dexamethasone', 'bortezomib/dexamethasone (Vd) alone', 'bortezomib/dexamethasone']","['progression-free survival (PFS', 'higher rates of MRD negativity and sustained MRD negativity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",498.0,0.142329,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.weisel@uke.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Division of Hematology/Oncology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'Tomer M', 'Initials': 'TM', 'LastName': 'Mark', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Lauri', 'Affiliation': 'Department of Hematology, Sunderbyn Hospital, Luleå, Sweden.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': 'Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': '""Seràgnoli"" Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Je-Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'University Medical Center of the Johannes Gutenberg University, Third Department of Medicine, Mainz, Germany.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Wolney', 'Initials': 'W', 'LastName': 'Barreto', 'Affiliation': 'University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Asher A', 'Initials': 'AA', 'LastName': 'Chanan-Khan', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Horvath', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ovilla', 'Affiliation': 'Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, Mexico.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Casneuf', 'Affiliation': 'Janssen Research & Development, LLC, Beerse, Belgium.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'DeAngelis', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00948-5']
1673,32819949,Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial.,"OBJECTIVES


To compare the effectiveness of dry needling (DN) versus percutaneous needle electrolysis (PNE) for improving the level of pain, function and quality of life (QoL) of patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points.
DESIGN


A prospective, parallel-group, randomised controlled trial with blinded outcome assessment.
SETTING


A single treatment facility in the State of Kuwait.
PARTICIPANTS


118 participants were screened for eligibility. Of these, 102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial.
INTERVENTIONS


Two parallel groups, one study arm received DN and a stretching protocol whereas the other arm received percutaneous needling electrolysis with a stretching protocol.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was the Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains. Secondary outcome measures included the 0-10 numerical rating scale pain visual analogue scale (VAS) scores, performed before and after each treatment session. In addition, QoL was measured using the EuroQoL-5 dimensions. All measurements were taken at baseline, at 4, 8, 12, 26 and 52 weeks.
RESULTS


Foot Pain domain improved at all time points for DN group (p<0.001; 29.7 (17.8 to 41.5)) and percutaneous needling electrolysis group (p<0.001; 32.7 (18.3 to 47.0)), without significant differences between groups. Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6 (-4.0 to -1.2)) and percutaneous needling electrolysis group (p<0.001; -3.0 (-4.5 to -1.6)). QoL improved at 4 weeks for both DN (p<0.01; 0.15 (0.5 to 0.25)) and percutaneous needling electrolysis group (p<0.01; 0.09 (0.01 to 0.17)) and at 8 and 52 weeks for the PNE group (p<0.01; 0.10 (0.02 to 0.18)), with significant differences between groups for the QoL at 52 weeks (p<0.05; 0.10 (0.01 to 0.18)). There were two small haematomas in the PNE group and one in the DN group. No serious adverse events were reported.
CONCLUSIONS


Both PNE and DN were effective for PHP management, reducing mean and maximum pain since the first treatment session, with long lasting effects (52 weeks) and significant differences between groups in the case of QoL at 52 weeks in favour of the PNE group.
TRIAL REGISTRATION NUMBER


NCT03236779.",2020,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"['patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points', 'A single treatment facility in the State of Kuwait', '118 participants were screened for eligibility', 'plantar heel pain', '102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial']","['percutaneous needling electrolysis with a stretching protocol', 'percutaneous needling electrolysis', 'dry needling (DN) versus percutaneous needle electrolysis (PNE', 'dry needling interventions', 'DN and a stretching protocol']","['QoL', 'Pain VAS scores', 'level of pain, function and quality of life (QoL', '0-10 numerical rating scale pain visual analogue scale (VAS) scores', 'serious adverse events', 'Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains', 'Foot Pain domain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",118.0,0.160401,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Arian', 'Affiliation': 'Physical Therapy, Kuwait Ministry of Health, Safat, Kuwait.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain pherrero@usj.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Bellosta-López', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-038033']
1674,32819960,Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).,"INTRODUCTION


Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.
METHODS AND ANALYSIS


A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.
ETHICS AND DISSEMINATION


This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.
TRIAL REGISTRATION NUMBER


ISRCTN14736486.",2020,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"['Patients with current LBP and no indicators of serious spinal pathology', 'primary care', 'primary care patients', 'patients with low back pain (LBP', 'Participants undergo a secondary screen for possible serious spinal pathology']","[""SupportBack' internet intervention, with or without physiotherapist telephone support"", 'internet intervention', 'usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support']","['pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis', 'physical function (using the Roland and Morris Disability Questionnaire', 'LBP-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",,0.160252,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK A.W.Geraghty@soton.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Keele Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, Newcastle, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Webley', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Durcan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Alannah', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bathers', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Butler-Walley', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Mansell', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Leigh', 'Affiliation': 'Patient and Public Involvement Representative, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040543']
1675,32819979,Prognostic value of 12 novel cardiological biomarkers in stable coronary artery disease. A 10-year follow-up of the placebo group of the Copenhagen CLARICOR trial.,"OBJECTIVE


To assess if 12 novel circulating biomarkers, when added to 'standard predictors' available in general practice, could improve the 10-year prediction of cardiovascular events and mortality in patients with stable coronary heart disease.
DESIGN


The patients participated as placebo receiving patients in the randomised clarithromycin for patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory.
SETTING


Five Copenhagen University cardiology departments and a coordinating centre.
PARTICIPANTS


1998 participants with stable coronary artery disease.
OUTCOMES


Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death.
RESULTS


When only 'standard predictors' were included, 83.4% of all-cause death predictions and 68.4% of composite outcome predictions were correct. Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors. Adding the remaining 10 biomarkers (high-sensitive assay cardiac troponin T; neutrophil gelatinase-associated lipocalin; osteoprotegerin; N-terminal pro-B-type natriuretic peptide; tumour necrosis factor receptor 1 and 2; pregnancy-associated plasma protein A; endostatin; YKL40; cathepsin-B), which were all individually significantly associated with the prediction of the two outcomes, increased the figures to 84.7% and 69.7%.
CONCLUSION


When 'standard predictors' routinely available in general practices are used for risk assessment in consecutively sampled patients with stable coronary artery disease, the addition of 10 novel biomarkers to the prediction model improved the correct prediction of all-cause death and the composite outcome by <1.5%.
TRIAL REGISTRATION NUMBER


NCT00121550.",2020,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","['Five Copenhagen University cardiology departments and a coordinating centre', '1998 participants with stable coronary artery disease', 'patients with stable coronary heart disease', 'consecutively sampled patients with stable coronary artery disease', 'patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory', 'stable coronary artery disease']","['log(cathepsin-S', 'clarithromycin', 'placebo']","['Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587453', 'cui_str': 'Cardiology department'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}]",1998.0,0.0905681,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark pwinkel@ctu.dk.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section of Biostatistics, Department of Public Health Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Cardiology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshopitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kasper Karmark', 'Initials': 'KK', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'The Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Family Medicine and Primary Care, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033720']
1676,32820002,Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol.,"INTRODUCTION


Intracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO 2 ) and ICP during the first 5 days following severe TBI.
METHODS AND ANALYSIS


Multicentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO 2  group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO 2  group is managed to maintain PbtO 2  ≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).",2020,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","['patients at the early phase of severe traumatic brain injury', '28 April 2016 (pre-results', '300 patients with severe TBI']","['ICP + PbtO 2  group', 'ICP']","['quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days', 'neurological status at 6 months as assessed using the extended Glasgow Outcome Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0378456', 'cui_str': '3,4,4a,10b-tetrahydro-4-propyl-2H,5H-(1)benzopyrano(4,3-b)-1,4-oxazin-9-ol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}]",300.0,0.102688,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","[{'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France jfpayen@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Francony', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Audibert', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Lorraine University, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Emmanuel L', 'Initials': 'EL', 'LastName': 'Barbier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Poitiers University Hospital and Poitiers Hospital, Pharmacology of antimicrobial agents, INSERM U1070, Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Toulouse University Hospital and Toulouse 3-Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gergele', 'Affiliation': 'Department of Intensive care, Ramsay Sante, Hopital Privé de la Loire, Saint-Etienne, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Puybasset', 'Affiliation': 'Department of Anaesthesia and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Vigue', 'Affiliation': 'Department of Anaesthesia and Intensive care, Centre Hospitalier Universitaire de Bicêtre, Assistance Publique - Hopitaux de Paris, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Skaare', 'Affiliation': 'Department of Public Health, Univ. Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC IMAG, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bouzat', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}]",BMJ open,['10.1136/bmjopen-2020-040550']
1677,32820015,Entospletinib in Combination with Induction Chemotherapy in Previously Untreated Acute Myeloid Leukemia: Response and Predictive Significance of  HOXA9  and  MEIS1  Expression.,"PURPOSE


Spleen tyrosine kinase (SYK) signaling is a proposed target in acute myeloid leukemia (AML). Sensitivity to SYK inhibition has been linked to  HOXA9  and  MEIS1  overexpression in preclinical studies. This trial evaluated the safety and efficacy of entospletinib, a selective inhibitor of SYK, in combination with chemotherapy in untreated AML.
PATIENTS AND METHODS


This was an international multicenter phase Ib/II study, entospletinib dose escalation (standard 3+3 design between 200 and 400 mg twice daily) + 7+3 (cytarabine + daunorubicin) in phase Ib and entospletinib dose expansion (400 mg twice daily) + 7+3 in phase II.
RESULTS


Fifty-three patients ( n  = 12, phase Ib and  n  = 41, phase II) with previously untreated  de novo  ( n  = 39) or secondary ( n  = 14) AML were enrolled (58% male; median age, 60 years) in this study. The composite complete response with entospletinib + 7+3 was 70%. Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared with patients with below median  HOXA9  and  MEIS1  expression. Common adverse events were cytopenias, febrile neutropenia, and infection. There were no dose-limiting toxicities. Entospletinib-related skin rash and hyperbilirubinemia were also observed.
CONCLUSIONS


Entospletinib with intensive chemotherapy was well-tolerated in patients with AML. Improved survival was observed in patients with  HOXA9/MEIS1  overexpression, contrasting published data demonstrating poor survival in such patients. A randomized study will be necessary to determine whether entospletinib was a mediator this observation.",2020,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"['Fifty-three patients (n=12 phase 1b, n=41 phase 2) with previously untreated de novo (n=39) or secondary (n=14) AML enrolled (58% male, median age 60 years', 'acute myeloid leukemia (AML']","['entospletinib dose escalation (standard 3+3 design between 200 mg and 400 mg BID) + 7+3 (cytarabine + daunorubicin', 'Induction Chemotherapy', 'Entosplentib with intensive chemotherapy']","['Entospletinib-related skin rash and hyperbilirubinemia', 'febrile neutropenia, and infection', 'no dose-limiting toxicities', 'overall survival', 'Improved survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0519043,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"[{'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Walker', 'Affiliation': 'The Ohio State University, Columbus, Ohio. Alison.Walker@osumc.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Blachly', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Bhatnagar', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Mims', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Orwick', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Howland E', 'Initials': 'HE', 'LastName': 'Crosswell', 'Affiliation': 'Bon Secours Mercy Health System, Greenville, South Carolina.'}, {'ForeName': 'Danjie', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Minden', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Oellerich', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Arati V', 'Initials': 'AV', 'LastName': 'Rao', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1064']
1678,32820473,Influence of the Chelating Solutions in the Resistance of Glass Fiber Posts to the Root Dentin.,"OBJECTIVE


This study aimed to evaluate the influence of chelating agents (EDTA, citric acid and Tetraclean) on glass fiber posts adhesion to root dentin.
MATERIALS AND METHODS


Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out. After, the samples were randomly divided into 4 groups (n = 10) to test the final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control). After 30 days of storage (36.5° C and 100% humidity), the post preparation was performed leaving 4 mm of apical endodontic filling. Then, a fiber-glass post previously selected was coated with ED Primer adhesive system and resin sealer Panavia, installed and stored for 24 hours at 37°C. The samples were subjected to a tensile test with a constant speed of 1 mm/min with 2000 Kgf. The results were analyzed with the ANOVA test.
RESULTS


The statistical analyzes indicated no significant differences between the groups (p > 0.05).
CONCLUSION


The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.",2020,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"['Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out']","['chelating agents (EDTA, citric acid and Tetraclean', 'final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control']",['tensile strength'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C2974342', 'cui_str': 'Tetraclean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}]",,0.0228196,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"[{'ForeName': 'Eduardo Fernandes', 'Initials': 'EF', 'LastName': 'Marques', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Marília Fagury Videira', 'Initials': 'MFV', 'LastName': 'Marceliano-Alves', 'Affiliation': 'Postgraduation Program, Iguaçu University, Nova Iguaçu, Brazil.'}, {'ForeName': 'Rina Andrea', 'Initials': 'RA', 'LastName': 'Pelegrine', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Campinas (PUC-Campinas), São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo Da Silveira', 'Initials': 'CEDS', 'LastName': 'Bueno', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}]",European journal of dentistry,['10.1055/s-0040-1714761']
1679,32822361,The effects of whole-body electromyostimulation (WB-EMS) in comparison to a multimodal treatment concept in patients with non-specific chronic back pain-A prospective clinical intervention study.,"BACKGROUND


According to present guidelines, active exercise is one key component in the comprehensive treatment of nonspecific chronic back pain (NSCBP). Whole body electromyostimulation (WB-EMS) is a safe, and time-effective training method, that may be effective in NSCBP-patients.
METHODS


In this prospective and controlled nonrandomized clinical study, two therapeutic approaches were compared. One group received 20 minutes WB-EMS per week. An active control group (ACG) received a multimodal therapy program. A third group included subjects without back pain. To all groups, the following measurement instruments were applied: Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability. In the EMS-group: T0: baseline; T1: at 6 weeks; T2: at 12 weeks and T3: at 24 weeks. In the ACG: T0 baseline and T1 after 4 weeks.
RESULTS


In the intervention group, 128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG. 34 subjects were allocated to the passive control group. The average age was 58.6 years (18-86 years). In the EMS group, the NRS (1-10) improved statistically and clinically significantly by 2 points. The ODI was reduced by 19.7 points. The NASS and most of the SF 36 items improved significantly. In the multimodal treatment group, only the muscular function improved slightly.
CONCLUSION


Our data support the hypothesis that WB-EMS is at least as effective as a multimodal treatment, which is often referred to as being the golden standard. Therefore WB-EMS may be an effective and, with 20 min./week training time, very time-efficient alternative to established multimodal treatment models.",2020,The NASS and most of the SF 36 items improved significantly.,"['The average age was 58.6 years (18-86 years', 'patients with non-specific chronic back pain', '128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG', '34 subjects']","['Whole body electromyostimulation (WB-EMS', 'whole-body electromyostimulation (WB-EMS', 'multimodal therapy program']","['muscular function improved slightly', 'subjects without back pain', 'ODI', 'Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",128.0,0.022024,The NASS and most of the SF 36 items improved significantly.,"[{'ForeName': 'Karl Lorenz', 'Initials': 'KL', 'LastName': 'Konrad', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Baeyens', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Birkenmaier', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Anna Helena', 'Initials': 'AH', 'LastName': 'Ranker', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Widmann', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Leukert', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenisch', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Kraft', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Jansson', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}]",PloS one,['10.1371/journal.pone.0236780']
1680,32841725,"A commentary on ""effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int. J. Surg. 2020; 80:13-18).",,2020,,['elderly patients undergoing hip joint replacement surgery'],['edaravone'],['postoperative cognitive function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Zhao-Jing', 'Initials': 'ZJ', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China. Electronic address: xuefushan@aliyun.com.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.020']
1681,32841825,A randomized study of CrossFit Kids for fostering fitness and academic outcomes in middle school students.,"Within the context of school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK) has emerged as a potential intervention for positively impacting students. The purpose of this study was to evaluate through a randomized-controlled trial how academic and health-related fitness outcomes differed for middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72). Questionnaire data were collected twice across the 9-month academic year and combined with FitnessGram and grade data. Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055]. Significant gender by time interaction effects were found for the relationship between CFK or PE participation and health-related fitness outcomes, but there were no significant interaction effects by gender on academic outcomes. Because developmental outcomes are conditional and result from the coaction of many factors, the findings suggest that some elements of CFK might be beneficial to build skills yet disadvantageous to academic outcomes.",2020,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","['middle school students (age = 12.73; 55.3 % male) who participated in a school-based CFK program (n=72) as compared to a group of students who participated in PE class (n=72', 'middle school students']","['school-based physical education (PE), a strength and conditioning program called CrossFit Kids (CFK', 'CrossFit Kids']","['health-related fitness outcomes', 'Questionnaire data', 'fostering fitness and academic outcomes']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}]",,0.0283754,"Students in both the intervention and comparison groups increased in health-related fitness outcomes (all p values < .017), and there was a significant treatment group by time interaction on school-reported grades [F(1, 124) = 7.270, p = .008, η_P^2 = .055].","[{'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Garst', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA. Electronic address: bgarst@clemson.edu.'}, {'ForeName': 'Edmond P', 'Initials': 'EP', 'LastName': 'Bowers', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Stephens', 'Affiliation': 'Department of Parks, Recreation, and Tourism Management, Clemson University, USA.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2020.101856']
1682,32841846,Decreased functional connectivity within the salience network after two-week morning bright light exposure in individuals with sleep disturbances: a preliminary randomized controlled trial.,"BACKGROUND


Bright light (BL) exposure is a safe non-pharmacological intervention for sleep disturbances. However, the functional brain correlates underlying the effects of bright light exposure need to be further clarified. As alterations in the salience network were reported in individuals with sleep disturbances, we have investigated whether bright light exposure may improve sleep quality by altering functional connectivity in this network.
METHODS


In the current study, 30 individuals with sleep disturbances were randomly assigned to one of the two interventions for two weeks: (1) 1 h of bright light (10,000 lux) exposure (BL-exposed group) and (2) 1 h of dim light (<300 lux) exposure (DL-exposed group). Sleep characteristics and functional connectivity in the salience network were assessed by sleep diary and resting-state functional magnetic resonance imaging, respectively, as outcome measures at before and after the intervention.
RESULTS


After two weeks of the intervention, the BL-exposed group showed greater improvement with respect to sleep efficiency (t = 2.27, p = 0.03) and sleep latency (t = -2.40, p = 0.03) as compared to the DL-exposed group. In addition, functional connectivity decreased in the cluster that encompasses the right anterior insular and the frontal opercular regions in the salience network (uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group. Decreased functional connectivity in the cluster was associated with decreased sleep latency in the BL-exposed group (β = 0.54, p = 0.01).
CONCLUSIONS


Our results suggest that bright light exposure may improve sleep quality in individuals with sleep disturbances by modulating functional connectivity in the salience network.
CLINICAL TRIAL REGISTRATION


https://cris.nih.go.kr/cris; KCT0002607.",2020,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","['individuals with sleep disturbances', '30 individuals with sleep disturbances']","['bright light (10,000 lux) exposure (BL-exposed group) and', 'Bright light (BL) exposure', 'bright light exposure']","['sleep efficiency', 'functional connectivity', 'Decreased functional connectivity', 'sleep latency', 'sleep quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.0552621,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Myeongju', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Gahae', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Soo Mee', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Department of Radiology, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'In Kyoon', 'Initials': 'IK', 'LastName': 'Lyoo', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Graduate School of Pharmaceutical Sciences, Ewha W. University, Seoul, South Korea; Department of Psychiatry, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: sujungjyoon@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.009']
1683,32843306,Embryo Ranking Intelligent Classification Algorithm (ERICA): artificial intelligence clinical assistant predicting embryo ploidy and implantation.,"RESEARCH QUESTION


Can a deep machine learning artificial intelligence algorithm predict ploidy and implantation in a known data set of static blastocyst images, and how does its performance compare against chance and experienced embryologists?
DESIGN


A database of blastocyst images with known outcome was applied with an algorithm dubbed ERICA (Embryo Ranking Intelligent Classification Algorithm). It was evaluated against its ability to predict euploidy, compare ploidy prediction against randomly assigned prognosis labels and against senior embryologists, and if it could rank an euploid embryo highly.
RESULTS


A total of 1231 embryo images were classed as good prognosis if euploid and implanted or poor prognosis if aneuploid and failed to implant. An accuracy of 0.70 was obtained with ERICA, with positive predictive value of 0.79 for predicting euploidy. ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively). ERICA ranked an euploid blastocyst first in 78.9% and at least one euploid embryo within the top two blastocysts in 94.7% of cases, better than random classification and the two senior embryologists. Average embryo ranking time for four blastocysts was under 25 s.
CONCLUSION


Artificial intelligence lends itself well to image pattern recognition. We have trained ERICA to rank embryos based on ploidy and implantation potential using single static embryo image. This tool represents a potentially significant advantage to assist embryologists to choose the best embryo, saving time spent annotating and does not require time lapse or invasive biopsy. Future work should be directed to evaluate reproducibility in different data sets.",2020,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).",[],[],['Average embryo ranking time'],[],[],"[{'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1231.0,0.0681082,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chavez-Badiola', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK. Electronic address: acb@EmbryoRanking.com.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Flores-Saiffe-Farías', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Mendizabal-Ruiz', 'Affiliation': 'Department of Computational Sciences, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Drakeley', 'Affiliation': ""IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; Hewitt Fertility Centre, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; ART Institute of Washington, Bethesda Maryland, USA; IVFqc, 1185 Sixth Avenue, New York New York, USA.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.003']
1684,32817358,"Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial.","OBJECTIVE


To evaluate efficacy and safety of lacosamide (up to 12 mg/kg/day or 400 mg/day) as adjunctive treatment for uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE).
METHODS


Phase 3, double-blind, randomised, placebo-controlled trial (SP0982; NCT02408523) in patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs. Primary outcome was time to second PGTCS during 24-week treatment.
RESULTS


242 patients were randomised and received ≥1 dose of trial medication (lacosamide/placebo: n=121/n=121). Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2%). Median treatment duration with lacosamide/placebo was 143/65 days. Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121). Median time to second PGTCS could not be estimated for lacosamide (>50% of patients did not experience a second PGTCS) and was 77.0 days for placebo. Kaplan-Meier estimated freedom from PGTCS at end of the 24-week treatment period (day 166) for lacosamide/placebo was 31.3%/17.2% (difference 14.1%; p=0.011). More patients on lacosamide than placebo had ≥50% (68.1%/46.3%) or ≥75% (57.1%/36.4%) reduction from baseline in PGTCS frequency/28 days, or observed freedom from PGTCS during treatment (27.5%/13.2%) (n=119/n=121). 96/121 (79.3%) patients on lacosamide had treatment-emergent adverse events (placebo 79/121 (65.3%)), most commonly dizziness (23.1%), somnolence (16.5%), headache (14.0%). No patients died during the trial.
CONCLUSIONS


Lacosamide was efficacious and generally safe as adjunctive treatment for uncontrolled PGTCS in patients with IGE.",2020,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","['primary generalised tonic-clonic seizures', 'uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE', 'patients with IGE', 'patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs', '242 patients', 'Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2']","['trial medication (lacosamide/placebo', 'lacosamide', 'lacosamide/placebo', 'adjunctive lacosamide', 'placebo']","['headache', 'dizziness', 'treatment-emergent adverse events', 'time to second PGTCS', 'Efficacy and safety', 'Median time to second PGTCS', 'somnolence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",242.0,0.731704,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA david_vossler@valleymed.org.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Knake', 'Affiliation': 'Department of Neurology, Epilepsy Centre Hessen, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Shinjuku Neuro Clinic, Tokyo, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steiniger-Brach', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roebling', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323524']
1685,32827526,Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease.,"OBJECTIVES


To evaluate the efficacy of Cogmed Working Memory Training compared with the standard of care to improve executive function and social outcomes in adolescents with congenital heart disease (CHD) who underwent open-heart surgery in infancy and to identify factors associated with changes in outcomes following the intervention.
STUDY DESIGN


In a single-center, randomized controlled trial, adolescents (13-16 years) with CHD were randomly assigned to either Cogmed (home-based 45-minutes sessions for 5-8 weeks) or to a control group. The primary outcome was working memory. Secondary outcomes included inhibitory control and cognitive flexibility as well as parent-reported executive function, symptoms of attention deficit hyperactivity disorder, and social outcomes. All measures were assessed at baseline, post-treatment (1-3 weeks post-training) and at 3-month follow-up. Data were analyzed using an intention-to-treat approach.
RESULTS


Sixty adolescents with CHD participated (28 assigned to Cogmed). No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory. Compared with the control group, participants assigned to the intervention demonstrated benefits in inhibitory control and attention at the 3-month follow-up (P = .02) and in parent-reported cognitive regulatory skills at post-treatment and 3-month follow-up (P = .02 and P = .04, respectively). Preterm birth, biventricular CHD, and history of attention deficit hyperactivity disorder diagnosis were associated with improved response to the intervention.
CONCLUSIONS


Cogmed intervention produced improvements in the self-regulatory control abilities of adolescents with CHD. The training did not enhance other areas of executive function or behavioral outcomes. Further studies are needed to evaluate the longer-term potential benefits to other domains.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT02759263.",2020,No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory.,"['Congenital Heart Disease', 'adolescents (13-16 years) with CHD', 'Sixty adolescents with CHD participated (28 assigned to Cogmed', 'adolescents with CHD', 'adolescents with congenital heart disease (CHD) who underwent open-heart surgery in infancy']","['Cogmed Working Memory Training', 'Working Memory Intervention']","['self-regulatory control abilities', 'executive function and social outcomes', 'Preterm birth, biventricular CHD and history of ADHD diagnosis', 'working memory', 'inhibitory control and cognitive flexibility as well as parent-reported executive function, ADHD symptoms and social outcomes', 'executive function or behavioral outcomes', 'cognitive regulatory skills']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0945375,No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Calderon', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA; Department of Psychiatry, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rofeberg', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stopp', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roseman', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Albers', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA; Department of Psychiatry, Harvard Medical School, Boston, MA; Department of Neurology, Boston Children's Hospital, Boston, MA; Department of Neurology, Harvard Medical School, Boston, MA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.038']
1686,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: A randomized controlled trial.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from Bauru, Brazil. The participants were randomly allocated into control and intervention groups (1:1), stratified by parental eHealth literacy scores (eHEALS) and children's caries experience. Every 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-ups, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer's exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influencing the reports about the children's consumption of sugar-free sweets and controlling the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
1687,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM


The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS


This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS


Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS


Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION


Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
1688,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1689,32830553,Hyperglycemia does not Inhibit Insulin's Effects on Microvascular Perfusion in Healthy Humans: A Randomized Crossover Study.,"Diabetes mellitus accelerates vascular disease through multiple biochemical pathways driven by hyperglycemia, with insulin resistance and/or hyperinsulinemia also contributing. Persons with diabetes mellitus experience premature large vessel and microvascular disease when compared to normoglycemic controls. Currently there is a paucity of clinical data identifying how acutely the vasculature responds to hyperglycemia and whether other physiologic factors (e.g., vasoactive hormones) contribute. To our knowledge, no prior studies have examined the dynamic effects of acute hyperglycemia on insulin-mediated actions on both micro- and macrovascular function in the same subjects. In this randomized crossover trial, healthy young adults underwent two infusion protocols designed to compare the effects of insulin infusion during euglycemia and hyperglycemia on micro- and macrovascular function. Both euglycemic- and hyperglycemic-hyperinsulinemia increased skeletal (but not cardiac) muscle microvascular blood volume (each p<0.02) and blood flow significantly (each p<0.04), and these increases did not differ between protocols. Hyperglycemic-hyperinsulinemia trended towards increased carotid-femoral pulse wave velocity (indicating increased aortic stiffness; p= 0.065 after Bonferroni adjustment), while euglycemic-hyperinsulinemia did not. There were no changes in post-ischemic flow velocity or brachial artery flow-mediated dilation during either protocol. Plasma endothelin-1 levels significantly decreased during both protocols (each p<0.02). In this study, acute hyperglycemia for 4 hours did not inhibit insulin's ability to increase skeletal muscle microvascular perfusion but did provoke a slight increase in aortic stiffness. Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.",2020,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"['healthy young adults', 'Persons with diabetes mellitus', 'Healthy Humans']",['insulin infusion during euglycemia and hyperglycemia'],"['blood flow', 'myocardial microvascular perfusion or endothelial function', 'Hyperglycemia', 'Plasma endothelin-1 levels', 'cardiac) muscle microvascular blood volume', 'euglycemic-hyperinsulinemia', 'post-ischemic flow velocity or brachial artery flow-mediated dilation', 'aortic stiffness', 'Hyperglycemic-hyperinsulinemia', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",,0.0219329,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Horton', 'Affiliation': 'Medicine, University of Virginia, United States.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'endocrinology, University of Virginia, United States.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Hartline', 'Affiliation': 'University of Virginia, United States.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Aylor', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Public Health Sciences, University of Virginia Medical Center, United States.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00300.2020']
1690,32830617,"The Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke.","In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention. Whether such learning principles apply to motor practice after stroke is unclear. Here, we developed novel mixed-effects models of the change in the perceived quality of arm movements during and following task practice. The models were fitted to data from a recent randomized controlled trial of the effect of dose of task practice in chronic stroke. Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice. Two additional effects modulated retention: a positive ""self-practice"" effect, and a negative effect of dose. Our results further suggest that for patients with sufficient arm use post-practice, self-practice will further improve use.",2020,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.",['chronic stroke'],[],"['Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",,0.0577901,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.","[{'ForeName': 'Chunji', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Engineering, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948609']
1691,32839158,Correction: Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,,2020,,['heterosexual couples'],"['HPV vaccination ', 'HPV vaccination']",[],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0545783,,[],BMJ open,['10.1136/bmjopen-2020-039383corr1']
1692,32840012,Effect of epigallocatechin-3-gallate on the status of DNA methylation of E-cadherin promoter region on endometriosis mouse.,"AIM


To evaluate whether epigallocatechin-3-gallate acts on endometriosis mouse, and changes the status of DNA methylation of E-cadherin promoter region.
METHODS


According to our previous research, the tracing nude mouse model of endometriosis was built up and randomly divided into three groups: control group (group A), epigallocatechin-3-gallate group (group B) and decitabine group (group C). Normal saline, epigallocatechin-3-gallate and decitabine were isometrically intraperitoneally injected into each group once in 2 days. In this period, the growth situations of lesions were monitored by living image system. After 16 days, the lesions were taken out and the distribution of E-cadherin and its methylated situation of promoter region were analyzed.
RESULTS


The region of interest of ectopic lesion increased from 4th to 16th day in group A (P < 0.01); in group B and C, the region of interest of ectopic lesion increased in the 0-8th day (P < 0.01), and decreased in the 8-16th day (P < 0.01). The positive expression rate of E-cadherin in group C was higher than group B, and group B was higher than group A (P < 0.01). The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
CONCLUSION


Epigallocatechin-3-gallate may inhibit the growth of endometrial lesion, affect the expression of E-cadherin on the cell membrane and reduce the status of DNA methylation of E-cadherin promoter region.",2020,"The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
",[],"['Normal saline, epigallocatechin-3-gallate and decitabine', 'decitabine', 'epigallocatechin-3-gallate', 'Epigallocatechin-3-gallate']","['region of interest of ectopic lesion', 'positive expression rate of E-cadherin']",[],"[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}]",,0.0206581,"The DNA methylation status of E-cadherin promoter region in group A was higher than group B, and group B was higher than group C (P < 0.01).
","[{'ForeName': 'Qi-Hui', 'Initials': 'QH', 'LastName': 'Guan', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wen-Jing', 'Initials': 'WJ', 'LastName': 'Shi', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Long-Shu', 'Initials': 'LS', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Allergy and Clinical Immunology, The State Key Laboratory of Respiratory Disease, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14358']
1693,32833851,Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block for clavicle surgery: A randomised double blind study.,"BACKGROUND


The complex innervation of the clavicle makes general anaesthesia a preferred technique for clavicular surgeries in current practice. The role and approach of regional anaesthesia remains unanswered.
OBJECTIVES


This study aims to delineate the relative effectiveness between interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB) as the anaesthetics for clavicular surgery.
DESIGN


A randomised, double-blind prospective study.
SETTING


Single-centre, tertiary care medical college and research institute.
PATIENTS


Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study.
INTERVENTION


All patients received interscalene block with 10 ml of 0.5% bupivacaine. Patients were randomised to undergo additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10 ml of 0.5% bupivacaine.
MAIN OUTCOME MEASURES


The block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications were noted. Categorical data were analysed using the chi-square test and Fisher's exact test. Continuous data were analysed using Student's t-test.
RESULT


In Group 1, block success was 100%. In Group 2, five patients failed to achieve adequate surgical anaesthesia (P = 0.02). The average sensory block onset time in Group 1 was 2.5 ± 0.4 min and was longer in Group 2, 4.3 ± 0.5 min (P < 0.001). There was no difference between the groups with respect to haemodynamic parameters and complications. The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
CONCLUSION


Ultrasound-guided combined interscalene and intermediate CPB had a better success rate, with faster sensory block onset time and prolonged postoperative analgesia as compared with interscalene and superficial CPB in patients undergoing clavicle surgery.
TRIAL REGISTRATION


Clinical trial registry of India (www.ctri.nic.in) - CTRI/2018/05/013785.",2020,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","['clavicle surgery', 'Single-centre, tertiary care medical college and research institute', ""Fifty patients with American Society of Anesthesiologist's (ASA) grade I to III, aged 18 to 70 years, scheduled for clavicular surgery, during May 2018 to April 2019 were enrolled in this study"", 'patients undergoing clavicle surgery']","['interscalene block with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided interscalene block combined with intermediate or superficial cervical plexus block', 'interscalene brachial plexus block with either intermediate cervical plexus or superficial cervical plexus block (CPB', 'interscalene and superficial CPB', 'additional ultrasound-guided intermediate CPB (Group-1) or superficial CPB (Group-2) with 10\u200aml of 0.5% bupivacaine', 'Ultrasound-guided combined interscalene and intermediate CPB']","['mean duration of postoperative analgesia', 'block success rate, sensory block onset time, haemodynamic parameters, duration of postoperative analgesia and complications', 'average sensory block onset time', 'adequate surgical anaesthesia', 'haemodynamic parameters and complications', 'block success']","[{'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0007854', 'cui_str': 'Cervical plexus structure'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0589495', 'cui_str': 'Interscalene approach'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",50.0,0.119153,"The mean duration of postoperative analgesia was longer in Group 1 (7.5 ± 0.8 h) as compared with Group 2 (5.7 ± 0.4 h, P < 0.001).
","[{'ForeName': 'B Krishna', 'Initials': 'BK', 'LastName': 'Arjun', 'Affiliation': 'Department of Anaesthesiology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Chinnamaregowda N', 'Initials': 'CN', 'LastName': 'Vinod', 'Affiliation': ''}, {'ForeName': 'Jayanna', 'Initials': 'J', 'LastName': 'Puneeth', 'Affiliation': ''}, {'ForeName': 'Madappa C', 'Initials': 'MC', 'LastName': 'Narendrababu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001300']
1694,32835925,Efficacy of donepezil for the attenuation of memory deficits associated with electroconvulsive therapy.,"We sought to confirm and extend the findings of studies that reported that acetylcholinesterase inhibitor drugs protect against electroconvulsive therapy (ECT)-induced cognitive impairment. We randomized 30 patients with depression (n=24) or schizophrenia (n=6) to receive either donepezil (10 mg/day; n=15) or placebo (n=15) during a fixed course of 6 thrice-weekly, modified, bifrontotemporal sine wave ECT, and for 30 days subsequently. We assessed memory using the Postgraduate Institute Memory Scale (PGI-MS) at baseline, and again at days 2, 7, and 30 after the ECT course. At baseline, memory functioning was comparable in the 2 groups. At 2 days post-ECT, memory functioning was impaired on almost all 10 subtests and on the total scale. At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself. There was no significant difference between groups in the primary outcome, improvement in PGI-MS scores between Days 2 and 30 post-ECT. On almost all subtests, also, there was no significant difference between groups. In summary, we found that donepezil (10 mg/day) did not improve memory outcomes after ECT.",2020,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.",['30 patients with depression (n=24) or schizophrenia (n=6) to receive either'],"['donepezil', 'placebo', 'electroconvulsive therapy']","['Postgraduate Institute Memory Scale (PGI-MS', 'memory outcomes', 'PGI-MS scores', 'memory functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.109804,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.","[{'ForeName': 'Lt Col Bikram', 'Initials': 'LCB', 'LastName': 'Dutta', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Col Pradyot', 'Initials': 'CP', 'LastName': 'Sarkar', 'Affiliation': 'Ohio Hospital, New Town, Kolkata, India. Electronic address: colpsarkar@live.com.'}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Dean (Basic Sciences), Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore 560 029, India. Electronic address: andradec@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113397']
1695,32836063,"Efficacy of scalp nerve blocks using ropivacaïne 0,75% associated with intravenous dexamethasone for postoperative pain relief in craniotomies.","Pain after supratentorial craniotomy is common, 55 % to 80 % of patients experience moderate to severe pain in the first 48 h(1-7). The importance of intravenous dexamethasone as an adjuvant to local anaesthetics is increasingly applied(1-7), however its role in scalp nerve blocks with ropivacaine 0.75 % remains unexplored in post-operative analgesia. We analyzed 134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with ropivacaine 0.75 %. The general anaesthesia was standardized and included 8 mg of intravenous dexamethasone at the induction. The postoperative pain was assessed using the numerical rating scale with patients in the post anaesthesia care unit and subsequently every 8 h in the neurosurgery unit until the 48th hour. A NRS value above 3 led to the administration of a rescue analgesic according to the defined protocol until an efficient analgesia was obtained. Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group. More than 60 % of the patients from the scalp nerve blocks group had an efficient analgesia without any rescue analgesic. Peroperatively the scalp nerve blocks group showed a decrease in opioid consumption and a better hemodynamic stability. No anesthetic or chirurgical complications related to the use of scalp blocks were observed. Scalp nerve blocks associated with intravenous dexamethasone are found to be a straightforward and efficient analgesic approach during supratentorial craniotomies.",2020,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","['134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with', 'craniotomies']","['dexamethasone', 'ropivacaïne', 'ropivacaine']","['efficient analgesia without any rescue analgesic', 'postoperative pain relief', 'severe pain', 'hemodynamic stability', 'Postoperative pain', 'Pain', 'opioid consumption', 'postoperative pain']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",134.0,0.065171,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaudray', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: eliott.gaudray@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""N' Guyen"", 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: cedric1.nguyen@intradef.gouv.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: edouard1.martin@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lyochon', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: arthur.lyochon@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dagain', 'Affiliation': 'Department of Neurosurgery, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: arnaud.dagain@intradef.gouv.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: julien.bordes@intradef.gouv.fr.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Cordier', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: pierre-yves.cordier@intradef.gouv.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: guillaume.lacroix@intradef.gouv.fr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106125']
1696,32841892,Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide.,"This study used a novel theory-informed latent class approach, based on the Interpersonal Psychological Theory of Suicide (IPTS), to identify subgroups of individuals with a suicide attempt history. The identification of subgroups can inform treatments that target these specific subgroups. Using data from a randomised controlled trial, latent class analysis was conducted on 227 adults with a suicide attempt history. Latent classes were identified based on suicide attempt history, perceived burdensomeness, thwarted belongingness, and capability for suicide at the trial baseline. Three classes were found. Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants). Class 1 had elevated suicidal ideation for the duration of the trial. Classes 1 and 2 also had elevated interpersonal risks relative to a population-based sample. These results suggest that some individuals with a suicide attempt history exhibit relatively low interpersonal risks, and given concurrent protective psychological factors, may be suited to low-intensity interventions. At the other extreme, some individuals with a suicide attempt history require high-intensity interventions addressing interpersonal risks, clinical symptoms, and protective psychological factors.",2020,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","['individuals with a suicide attempt history', 'Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide', '227 adults with a suicide attempt history']",[],"['elevated suicidal ideation', 'interpersonal risks and clinical symptoms, and lower protective psychological factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033906', 'cui_str': 'Psychological Theories'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",227.0,0.0482775,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","[{'ForeName': 'Quincy J J', 'Initials': 'QJJ', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia; School of Psychology, Western Sydney University, Sydney, NSW, Australia. Electronic address: q.wong@westernsydney.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}]",Psychiatry research,['10.1016/j.psychres.2020.113406']
1697,32842013,"Pre-emptive topical lidocaine 5% plaster for prevention of post-craniotomy pain: a protocol for a multicentred, randomized, triple-blind, placebo-controlled clinical trial.",,2020,,[],"['placebo', 'lidocaine']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",[],,0.530178,,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Peking University Third Hospital, Center for Precision Neurosurgery and Oncology, Peking University Health Science Center, Beijing 100191, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001066']
1698,32844550,Postprandial Triglyceride-Rich Lipoproteins from Type 2 Diabetic Women Stimulate Platelet Activation Regardless of the Fat Source in the Meal.,"SCOPE


The aim of this study is to examine whether postprandial (PP) triglyceride-rich lipoproteins (TGRL) secreted after a moderate fat intake would activate platelets differently according to their fatty acid (FA) composition.
METHODS AND RESULTS


In a parallel single-blind randomized trial, 30 women with type 2 diabetes are assigned a breakfast containing 20 g lipids from butter versus hazelnut-cocoa spread (HCS) rich in palm oil. Blood samples are collected at fasting and 4 h PP. FA composition of fasting and PP TGRL and their effects on the activation of platelets from healthy blood donors are assessed. Both breakfasts similarly increase plasma ApoB-48, plasma, and TGRL triglycerides (p < 0.05). TGRL mean diameter increases after both breakfasts and is greater after the butter breakfast. Both breakfasts are rich in palmitic acid, and the HCS breakfast contains 45% oleic acid. TGRL FA composition reflects the dietary FA composition. Pre-incubation of platelets with fasting and PP TGRL increases collagen-stimulated aggregation (p < 0.01 vs control). Fasting and PP TGRL similarly increase agonist-induced thromboxane B 2  concentrations, and this effect is concentration-dependent for PP TGRL.
CONCLUSION


PP TGRL from type 2 diabetic women after a palm-oil spread versus butter-based mixed meal induce similar acute in vitro platelet activation.",2020,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).",['30 women with type 2 diabetes'],"['breakfast containing 20 g lipids from butter vs hazelnut cocoa spread rich in palm oil', 'PP TGRL']","['Postprandial Triglyceride-Rich Lipoproteins', 'incubation of platelets with fasting and PP TGRL increased collagen-stimulated aggregation', 'Blood samples', 'plasma ApoB-48, plasma and TGRL triglycerides', 'FA composition of fasting and PP TGRL', 'Platelet Activation', 'postprandial (PP) triglyceride-rich lipoproteins (TGRL', 'TGRL mean diameter']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0440288', 'cui_str': 'Hazelnut'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0069962', 'cui_str': 'Palm Oil'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1096194', 'cui_str': 'Lipoprotein (a) increased'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0065060', 'cui_str': 'lipoprotein triglyceride'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",30.0,0.059224,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).","[{'ForeName': 'Marie Michèle', 'Initials': 'MM', 'LastName': 'Boulet', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheillan', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Di Filippo', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Taïssia', 'Initials': 'T', 'LastName': 'Lelekov-Boissard', 'Affiliation': ""Fédération d'endocrinologie, Maladies Métaboliques, Diabète et Nutrition, Hôpital Louis Pradel, Hospices Civils de Lyon, Bron, 69500, France.""}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Buisson', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, 69310, France.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Nazare', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, 69310, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tressou', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRAE, Paris-Saclay University, Paris, 75005, France.'}, {'ForeName': 'Marie-Caroline', 'Initials': 'MC', 'LastName': 'Michalski', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Calzada', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moulin', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000694']
1699,32827053,Dissection with LigaSure Impact™ versus conventional resection in pylorus-preserving partial pancreatoduodenectomy (DISSECT): a single-institution randomized controlled trial.,"PURPOSE


In partial pancreatoduodenectomy, appropriate effective hemostasis during dissection is of major importance for procedural flow, operation time, and postoperative outcome. As ligation, clipping, or suturing of blood vessels is time-consuming and numerous instrument changes are required, the primary aim of this randomized controlled trial was to assess whether LigaSure Impact™ exhibits benefits over named conventional dissection techniques in patients undergoing pylorus-preserving partial pancreatoduodenectomy.
METHODS


This single-institution, randomized, superiority trial was performed between September 27, 2009, and February 24, 2012. Patients undergoing pylorus-preserving partial pancreatoduodenectomy were allocated to the study arms in a 1:1 ratio based on an unstratified block randomization with random block sizes to receive either dissection with LigaSure Impact™ or conventional dissection. The primary endpoint was operation time. Secondary endpoints included peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay. To observe a time reduction of 40 min, 51 patients per arm were required. The primary analysis was the intention to treat.
RESULTS


The mean operation time did not differ between the Ligasure Impact™ (308 min; SD: 56 min; range: 155-455 min) and the conventional dissection (318 min; SD: 90 min, range: 175-550 min) (p = 0.531). Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
CONCLUSIONS


The application of LigaSure Impact™ dissection in pylorus-preserving partial pancreatoduodenectomy does not increase effectiveness and safety of dissection.
TRIAL REGISTRATION


DRKS00000166.",2020,"Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
","['Patients undergoing pylorus-preserving partial pancreatoduodenectomy', 'September 27, 2009, and February 24, 2012', 'pylorus-preserving partial pancreatoduodenectomy (DISSECT', 'patients undergoing pylorus-preserving partial pancreatoduodenectomy']","['Dissection with LigaSure Impact™ versus conventional resection', 'dissection with LigaSure Impact™ or conventional dissection']","['peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay', 'peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay', 'intention to treat', 'mean operation time', 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.269743,"Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gehrig', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. tobias.gehrig@spital-linth.ch.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Josef', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Billeter', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Warschkow', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Gutt', 'Affiliation': 'Department of General, Vascular, Thoracic and Visceral Surgery, Klinikum Memmingen, 87700, Memmingen, Germany.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tarantino', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01968-y']
1700,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
1701,32827729,Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-Blind Placebo-Controlled Single-Center Study.,"BACKGROUND


Chronic idiopathic/spontaneous urticaria (CSU) is a common disease with a significant proportion of patients who do not respond to standard therapy with antihistamines and optionally corticosteroids/immunosuppressants.
OBJECTIVE


The IL-1β antagonist canakinumab is effective in cryopyrin-associated periodic syndromes associated with urticarial symptoms and urticarial vasculitis, and so it was suspected that it could also be effective in patients with CSU.
METHODS


The effect of canakinumab was investigated in 20 patients with moderate to severe CSU in a 1:1 randomization to either canakinumab or placebo in a double-blind single-dose crossover design. The verum group received 150 mg canakinumab subcutaneously once at baseline. Patients who had received placebo were able to switch to canakinumab at week 4 if they did not improve. The primary end point was clinical improvement at week 4 compared with baseline in sum of urticaria activity scores over 7 consecutive days. Secondary end points were the clinical improvement at week 8 compared with baseline in sum of urticaria activity scores over 7 consecutive days and the clinical improvement measured by the Physician Score and Dermatology Life Quality Index at week 1, 2, 4, and 8.
RESULTS


At week 4, 2 patients with canakinumab and 3 with placebo met the primary end point, and so canakinumab failed the significant superiority to the placebo (P = 1.0). An inclusion of the patients who switched to canakinumab after 4 weeks did not alter the result. There was also no significant difference between the verum and placebo groups for all secondary end points. The therapy was well tolerated, and mild adverse events were equally distributed between verum and placebo groups.
CONCLUSIONS


Because of this clinical trial with 20 patients, it must be assumed that canakinumab has no effect on lesions of CSU. This suggests that IL-1β may not play a crucial role in pathology of patients with CSU, unlike, for example, in hereditary fevers or urticarial vasculitis, where targeting IL-1 is a main treatment option. However, the good tolerability of canakinumab could be confirmed.",2020,There was also no significant difference between the verum and placebo groups for all secondary endpoints.,"['Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria', '20 patients', '20 patients with moderate to severe CSU in a 1:1 randomization to either', 'Chronic spontaneous urticaria (CSU', 'patients with CSU']","['canakinumab', 'Placebo', 'canakinumab or placebo', 'placebo']","['clinical UAS7 improvement at week 8 and the clinical improvement measured by the physician score and DLQI', 'tolerated, and mild AEs', 'clinical UAS7 improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",20.0,0.409359,There was also no significant difference between the verum and placebo groups for all secondary endpoints.,"[{'ForeName': 'Julia-Tatjana', 'Initials': 'JT', 'LastName': 'Maul', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland. Electronic address: julia-tatjana.maul@usz.ch.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland; Christine Kühne Center for Allergy Research and Education CK-CARE Davos, Davos, Switzerland.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kolios', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland; Department of Immunology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lara Valeska', 'Initials': 'LV', 'LastName': 'Maul', 'Affiliation': 'Department of Dermatology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Guillet', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Graf', 'Affiliation': 'Graf Biostatistics, Zurich, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Imhof', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Navarini', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland; Department of Dermatology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid-Grendelmeier', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland; Christine Kühne Center for Allergy Research and Education CK-CARE Davos, Davos, Switzerland.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.07.058']
1702,32831169,A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini.,"Background:  Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy's impact on the economic aspects of patients' lives remains unknown.  Methods:  We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients' individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm 3  until September 2016 and <500 cells/mm 3  thereafter) to the 'Early Initiation of ART for All' (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients' time use, employment status, household expenditures, and household living standards.  Results:  A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households' asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients' sex, age, education, timing of HIV diagnosis and ART initiation.  Conclusions:  Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.  Funding:  Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.  Clinical trial number: ClinicalTrials.gov, NCT02909218 and NCT03789448.",2020,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","['Fourteen healthcare facilities', ""HIV patients' economic welfare in Eswatini"", ""patients' economic welfare"", 'A total sample of 3,019 participants were interviewed over the duration of the study']","['immediate ART initiation', 'antiretroviral therapy (ART']","['Employment and household expenditures', 'time use, employment status, household expenditures and household wealth', 'non-resting time use']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",3019.0,0.412335,"Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93","[{'ForeName': 'Janina Isabel', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Cebele', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Acccess Initiative, Boston, United States.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, United States.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vollmer', 'Affiliation': 'University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Sikhathele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Ministry of Health of the Kingdom of Eswatini, Mbabane, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany.'}]",eLife,['10.7554/eLife.58487']
1703,32838555,Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions.,"BACKGROUND


Cluster randomized trials are designed to evaluate interventions at the cluster or group level. When clusters are randomized but some clusters report no or non-analyzable data, intent-to-treat analysis, the gold standard for the analysis of randomized controlled trials, can be compromised. This article presents a very flexible statistical methodology for cluster randomized trials whose outcome is a cluster-level proportion (e.g. proportion from a cluster reporting an event) in the setting where clusters report non-analyzable data (which in general could be due to nonadherence, dropout, missingness, etc.). The approach is motivated by a previously published stratified randomized controlled trial called, ""The Randomized Recruitment Intervention Trial (RECRUIT),"" designed to examine the effectiveness of a trust-based continuous quality improvement intervention on increasing minority recruitment into clinical trials (ClinicalTrials.gov Identifier: NCT01911208).
METHODS


The novel approach exploits the use of generalized estimating equations for cluster-level reports, such that all clusters randomized at baseline are able to be analyzed, and intervention effects are presented as risk ratios. Simulation studies under different outcome missingness scenarios and a variety of intra-cluster correlations are conducted. A comparative analysis of the method with imputation and per protocol approaches for RECRUIT is presented.
RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate. Application to RECRUIT shows similar effect sizes when compared to the imputation and per protocol approach.
CONCLUSION


The article demonstrates that an innovative bivariate generalized estimating equations framework allows one to implement an intent-to-treat analysis to obtain risk ratios or odds ratios, for a variety of cluster randomized designs.",2020,"RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.",[],['trust-based continuous quality improvement intervention'],[],[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.232914,"RESULTS


Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate.","[{'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Ruosha', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Yefei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotions and Behavioral Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520936668']
1704,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
1705,32843515,"Ultrasound-guided bilateral pudendal nerve blocks of nulliparous women with epidural labour analgesia in the second stage of labour: a randomised, double-blind, controlled trial.","OBJECTIVE


To explore whether an ultrasound-guided pudendal nerve block (PNB) could decrease anaesthetic use, thereby shortening the length of the second stage of labour in women undergoing epidural analgesia.
DESIGN


Prospective, single-centre, randomised, double-blind, controlled trial.
SETTING


An obstetric centre in a general hospital in China.
PARTICIPANTS


72 nulliparous women were randomised, and 71 women completed the study.
INTERVENTION


An ultrasound-guided bilateral PNB was administered to all study participants; the PNB group were given 0.25% ropivacaine 10 mL, while the control group were given 10 mL saline.
MAIN OUTCOME MEASURE


The primary outcome measure was the duration of the second stage of labour. Secondary outcomes included additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30 min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain.
RESULTS


The duration of the second stage of labour was shorter in the PNB group than in the control group (difference of 33.8 min (95% CI 15.6 to 52.0), p<0.001). Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001). DRAM2 was greater (p<0.001), rate of parturient women with the urge to defecate was higher (p=0.014), maternal cooperation was superior (p=0.002), and lower limb motor function preservation was greater (p=0.004) in the PNB group relative to the control group. Tightness of the perineum was eliminated from the results due to the inconsistent application of the criteria by the nursing staff. There was no significant difference in NRS scores between the groups.
CONCLUSIONS


Nulliparous women with epidural analgesia who received an ultrasound-guided bilateral PNB may reduce their need for bupivacaine and consequently shorten the length of the second stage of labour, therein indicating that a bilateral PNB may serve as an additional effective adjunct method of labour analgesia.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-16009121.",2020,Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001).,"['nulliparous women with epidural labour analgesia in the second stage of labour', 'women undergoing epidural analgesia', 'An obstetric centre in a general hospital in China', '72 nulliparous women were randomised, and 71 women completed the study', 'Nulliparous women with epidural analgesia who received an']","['bupivacaine', 'Ultrasound-guided bilateral pudendal nerve blocks', 'ultrasound-guided bilateral PNB', 'ultrasound-guided pudendal nerve block (PNB', 'ropivacaine 10\u2009mL, while the control group were given 10\u2009mL saline']","['additional bolus administration, total hourly bupivacaine consumption, difference in thickness between the contracted and relaxed rectus abdominis muscle before (DRAM1) and 30\u2009min after (DRAM2) PNB, urge to defecate, maternal cooperation, preservation of the lower limb motor function, tightness of the perineum, and Numeric Rating Scale (NRS) score for pain', 'maternal cooperation', 'total hourly bupivacaine consumption', 'rate of parturient women with the urge to defecate', 'NRS scores', 'duration of the second stage of labour', 'DRAM2', 'lower limb motor function preservation']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}]",72.0,0.379508,Additional bolus administration and total hourly bupivacaine consumption were lower in the PNB group than in the control group (p<0.001).,"[{'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynecology, Zhejiang University School of Medicine Women's Hospital, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Riyong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Weijue', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Papadimos', 'Affiliation': 'Department of Anesthesiology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Junzhao', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China z.joyce08@163.com xuzhong@263.net.""}, {'ForeName': 'Xuzhong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China z.joyce08@163.com xuzhong@263.net.'}]",BMJ open,['10.1136/bmjopen-2019-035887']
1706,32843517,CASNET2: evaluation of an electronic safety netting cancer toolkit for the primary care electronic health record: protocol for a pragmatic stepped-wedge RCT.,"INTRODUCTION


Safety-netting in primary care is the best practice in cancer diagnosis, ensuring that patients are followed up until symptoms are explained or have resolved. Currently, clinicians use haphazard manual solutions. The ubiquitous use of electronic health records provides an opportunity to standardise safety-netting practices.A new electronic safety-netting toolkit has been introduced to provide systematic ways to track and follow up patients. We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
METHODS AND ANALYSIS


We will conduct a stepped-wedge cluster RCT in 60 general practices within the RCGP Research and Surveillance Centre (RSC) network. Groups of 10 practices will be randomised into the active phase at 2-monthly intervals over 12 months. All practices will be activated for at least 2 months. The primary outcome is the primary care interval measured as days between the first recorded symptom of cancer (within the year prior to diagnosis) and the subsequent referral to secondary care. Other outcomes include referrals rates and rates of direct access cancer investigation.Analysis of the clustered stepped-wedge design will model associations using a fixed effect for intervention condition of the cluster at each time step, a fixed effect for time and other covariates, and then include a random effect for practice and for patient to account for correlation between observations from the same centre and from the same participant.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the North West-Greater Manchester West National Health Service Research Ethics Committee (REC Reference 19/NW/0692). Results will be disseminated in peer-reviewed journals and conferences, and sent to participating practices. They will be published on the University of Oxford Nuffield Department of Primary Care and RCGP RSC websites.
TRIAL REGISTRATION NUMBER


ISRCTN15913081; Pre-results.",2020,"We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
",['60 general practices within the RCGP Research and Surveillance Centre (RSC) network'],['CASNET2'],"['referrals rates and rates of direct access cancer investigation', 'primary care interval measured as days between the first recorded symptom of cancer (within the year prior to diagnosis) and the subsequent referral to secondary care']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}]",60.0,0.193035,"We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web.
","[{'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Fleming', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Nicholson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK brian.nicholson@phc.ox.ac.uk.'}, {'ForeName': 'Afsana', 'Initials': 'A', 'LastName': 'Bhuiya', 'Affiliation': 'North Central and East London Cancer Alliance, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perera', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sherlock', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Yonova', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Bankhead', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038562']
1707,32843527,PIK3CA  Mutation in the ShortHER Randomized Adjuvant Trial for Patients with Early HER2 +  Breast Cancer: Association with Prognosis and Integration with PAM50 Subtype.,"PURPOSE


We explored the prognostic effect of  PIK3CA  mutation in HER2 +  patients enrolled in the ShortHER trial.
PATIENTS AND METHODS


The ShortHER trial randomized 1,253 patients with HER2 +  breast cancer to 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy.  PIK3CA  hotspot mutations in exon 9 and 20 were analyzed by pyrosequencing. Expression of 60 genes, including PAM50 genes was measured using the nCounter platform.
RESULTS


A mutation of the  PIK3CA  gene was detected in 21.7% of the 803 genotyped tumors. At a median follow-up of 7.7 years, 5-year disease-free survival (DFS) rates were 90.6% for  PIK3CA  mutated and 86.2% for  PIK3CA  wild-type tumors [HR, 0.84; 95% confidence interval (CI), 0.56-1.27;  P  = 0.417].  PIK3CA  mutation showed a favorable prognostic impact in the PAM50 HER2-enriched subtype ( n  = 232): 5-year DFS 91.8% versus 76.1% (log-rank  P  = 0.049; HR, 0.46; 95% CI, 0.21-1.02). HER2-enriched/ PIK3CA  mutated versus wild-type tumors showed numerically higher tumor-infiltrating lymphocytes (TIL) and significant upregulation of immune-related genes (including  CD8A, CD274, PDCD1,  and  MYBL2 , a proliferation gene involved in immune processes). High TILs as well as the upregulation of  PDCD1  and  MYBL2  were associated with a significant DFS improvement within the HER2-enriched subtype (HR, 0.82; 95% CI, 0.68-0.99;  P  = 0.039 for 10% TILs increment; HR, 0.81; 95% CI, 0.65-0.99;  P  = 0.049 for  PDCD1  expression; HR, 0.72; 95% CI, 0.53-0.99;  P  = 0.042 for  MYBL2  expression).
CONCLUSIONS


PIK3CA  mutation showed no prognostic impact in the ShortHER trial. Within the HER2-enriched molecular subtype, patients with  PIK3CA  mutated tumors showed better DFS versus  PIK3CA  wild-type, which may be partly explained by upregulation of immune-related genes.",2020,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","['HER2-positive patients enrolled in the ShortHER trial', 'patients with early HER2+ breast cancer', '1253 patients with HER2-positive breast cancer to 9-weeks or 1-year of adjuvant']","['PIK3CA', 'trastuzumab combined with chemotherapy']","['5-yr disease-free survival (DFS) rates', 'Expression of 60 genes, including PAM50 genes', 'tumor infiltrating lymphocytes (TILs) and significant upregulation of immune-related genes (including CD8A, CD274, PDCD1 and MYBL2, a proliferation gene involved in immune processes']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C1505106', 'cui_str': 'MYBL2 protein, human'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",1253.0,0.164005,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Dieci', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. mariavittoria.dieci@unipd.it.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Bisagni', 'Affiliation': 'Department of Oncology and Advanced Technologies, Reggio Emilia, Italy.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology, Azienda Unità Sanitaria Locale di Bologna-IRCCS Istituto delle Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frassoldati', 'Affiliation': 'Clinical Oncology, Department of Morphology, Surgery and Experimental Medicine, S Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Department of Oncology-Hematology, G. da Saliceto Hospital, Piacenza, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Musolino', 'Affiliation': 'Medical Oncology and Breast Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'IRCCS Istituto Tumori ""Giovanni Paolo II"" di Bari, Parma, Italy.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Rimanti', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Mantova, Mantova, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Breast Unit, Medical Oncology, A.O.S. Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bertone', 'Affiliation': 'Department of Gynecology and Obstetrics, Ospedale S. Anna, Turin, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': 'Breast Unit Ausl Modena, Ramazzini Hospital, Carpi, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Piacentini', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Orvieto', 'Affiliation': 'Pathology Unit, Rovigo, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Curtarello', 'Affiliation': 'Immunology and Molecular Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Urso', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Medical and Surgical Sciences for Children & Adults, University of Modena, Modena, Italy.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1731']
1708,32832985,Effects of an intervention to reduce fear of falling and increase physical activity during hip and pelvic fracture rehabilitation.,"BACKGROUND


fear of falling and reduced fall-related self-efficacy are frequent consequences of falls and associated with poorer rehabilitation outcomes. To address these psychological consequences, geriatric inpatient rehabilitation was augmented with a cognitive behavioural intervention (""Step by Step"") and evaluated in a RCT.
METHODS


one hundred fifteen hip and pelvic fracture patients (age = 82.5 years, 70% female) admitted to geriatric inpatient rehabilitation were randomly allocated to the intervention or control group. The intervention consisted of eight additional individual sessions during inpatient rehabilitation, one home visit and four telephone calls delivered over 2 months after discharge. Both groups received geriatric inpatient rehabilitation. Primary outcomes were fall-related self-efficacy (short falls efficacy scale-international) and physical activity as measured by daily walking duration (activPAL3™ sensor) after admission to rehabilitation, before discharge and 1-month post-intervention.
RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition. Further significant effects in favour of the intervention group were found in the secondary outcomes ""perceived ability to manage falls"" (P = 0.031, d = 0.41), ""physical performance"" (short physical performance battery) (P = 0.002, d = 0.58) and a lower ""number of falls"" (P = 0.029, d = -0.45).
CONCLUSIONS


the intervention improved psychological and physical performance measures but did not increase daily walking duration. For the inpatient part of the intervention further research on the required minimum intensity needed to be effective is of interest. Duration and components used to improve physical activity after discharge should be reconsidered.",2020,"RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition.","['one hundred fifteen hip and pelvic fracture patients (age\u2009=\u200982.5\xa0years, 70% female) admitted to geriatric inpatient rehabilitation', 'hip and pelvic fracture rehabilitation']","['geriatric inpatient rehabilitation', 'cognitive behavioural intervention (""Step by Step']","['fall-related self-efficacy (short falls efficacy scale-international) and physical activity as measured by daily walking duration (activPAL3™ sensor) after admission to rehabilitation, before discharge and 1-month post-intervention', 'psychological and physical performance measures', 'physical performance"" (short physical performance battery', 'fear of falling and increase physical activity', 'physical activity', 'daily walking duration', 'total daily walking duration', 'lower ""number of falls', 'secondary outcomes ""perceived ability to manage falls', 'fall-related self-efficacy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]",115.0,0.0170878,"RESULTS


in covariance analyses, patients in the intervention group showed a significant improvement in fall-related self-efficacy (P = 0.025, d = -0.42), but no difference in total daily walking duration (P = 0.688, d = 0.07) 1-month post-intervention compared to the control condition.","[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kampe', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klenk', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Rapp', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Albrecht', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Büchele', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Eberhard Karls University, Tubingen, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Taraldsen', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}]",Age and ageing,['10.1093/ageing/afaa050']
1709,32829109,High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production in obese men in response to an acute exercise bout.,"The aim of this study was to evaluate the inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin) profile of inactive obese men in response to two isoenergetic models of aerobic exercise training (~300  kcal each exercise session). Twenty-two participants (28.7 ± 1.6 years; BMI = 34.4 ± 0.1 kg/m 2 ) were randomized into two groups: I) HIIT: high-intensity interval training (10× 1 bout: 1 min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT). Both groups trained three times per week for 6-weeks. Fasting blood samples were collected before and 0, 30, and 60 min after exercise during the first and last training sessions for evaluation of: I) MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10 were analyzed before, 0, and 60 min after sessions. IL-6 concentration remained elevated up to 60-min after the acute exercise session (p < 0.001), and IL-10 concentration was higher after 30 and 60-min (p = 0.001) compared to rest, independent of training period and protocol. AUC of IL-10 presented effect of type of training (p = 0.023) with MICT group showed significantly higher values than the HIIT. The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period. Fifteen subjects presented decreased HOMA-IR after 6-weeks and seven presented an increase in this index. When we excluded the two least responsive subjects, it was possible to observe a decrease in HOMA-IR (p = 0.020) after training. Taken together, our results suggest that both HIIT and MICT (with same energy expenditure) promote similar effects on HOMA-IR and led to elevations in IL-10 production in LPS-stimulated whole blood, suggesting that leukocytes had an enhanced ability to secrete anti-inflammatory cytokines after the exercise bout.",2020,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","['Twenty-two participants (28.7\xa0±\xa01.6\xa0years; BMI\xa0=\xa034.4\xa0±\xa00.1\xa0kg/m 2 ', 'obese men in response to an acute exercise bout', 'inactive obese men']","['MICT', 'HIIT and MICT', 'IL-6', 'inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin', 'HIIT: high-intensity interval training (10× 1 bout: 1\xa0min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT', 'aerobic exercise training', 'High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production']","['MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10', 'HOMA-IR', 'Fasting blood samples', 'IL-10 secretion', 'concentration', 'IL-10 concentration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0237388,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil; Physical Education, Physiotherapy, University Center of Maringa (UniCesumar), Parana, Brazil.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Cesar', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil. Electronic address: fabio.lira@unesp.br.'}]",Cytokine,['10.1016/j.cyto.2020.155249']
1710,32830635,Prolonged intra-operative thermal exposure in endoscopic ear surgery: is it really safe?,"OBJECTIVE


The aim of this study was to assess change in temperature, audiometric outcomes and post-operative complications following exposure to different light sources during endoscopic ear surgery.
METHOD


A total of 64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty. The patients were randomised into two groups based on the light source used: xenon or light-emitting diode. Temperature was measured using a K type thermocouple at the promontory and round window niche. Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting in the first 24 hours, vertigo and tinnitus at the end of the first week were observed.
RESULTS


Mean temperature change showed a statistically significant difference with increasing length of operating time with the xenon light source and when the two light sources were compared for a particular time interval. Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source. When the mean audiometric change was compared between light sources for a particular frequency, statistical significance was found at 4, 6 and 8 kHz. Post-operative complications were vomiting, vertigo and tinnitus (p-values of 0.042, 0.099 and 0.147, respectively, between two groups).
CONCLUSION


Light emitting diodes are associated with less significant middle-ear temperature rises and audiometric changes at higher frequencies when compared to xenon light sources. Hence, xenon should be replaced with cooler light sources.",2020,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","['64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty', 'endoscopic ear surgery']",['light source used: xenon or light-emitting diode'],"['vertigo and tinnitus', 'Mean audiometric change', 'change in temperature, audiometric outcomes', 'length of operating time', 'mean audiometric change', 'vomiting, vertigo and tinnitus', 'Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}]","[{'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",64.0,0.0279896,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001449']
1711,32836201,Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.,"BACKGROUND


There is a lack of prognostic models predicting the overall survival (OS) of advanced breast cancer (ABC) patients in China.
METHODS


Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants were enrolled in this study, which were further randomized 3:1 and divided into training (n = 1706) and validation (n = 557) groups. The nomogram was built based on independent predictors identified by univariate and multivariate cox regression analyses. The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
RESULTS


Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) score, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly related to OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) for the training set and 0.686 (95% CI: 0.652-0.719) for the validation set. The calibration curves revealed satisfactory consistency between actual survival and nomogram prediction in both the internal and external validations. The nomogram was capable of stratifying patients into different risk cohorts.
CONCLUSIONS


We constructed and validated a nomogram that might serve as an efficient tool to provide prognostic prediction for ABC patients and guide the physicians to make personalized treatment decisions.",2020,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","['advanced breast cancer patients in China', 'Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants', 'advanced breast cancer (ABC) patients in China']",[],['overall survival (OS'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",4039.0,0.0279926,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","[{'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Hongnan', 'Initials': 'H', 'LastName': 'Mo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China. Electronic address: xubinghe@medmail.com.cn.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.004']
1712,32835416,Intravenous immunoglobulin for presumed viral myocarditis in children and adults.,"BACKGROUND


This is an update of a previous review. Case reports and case series have described dramatic responses to intravenous immunoglobulin (IVIG) in people with presumed viral myocarditis, and its administration has become commonplace.
OBJECTIVES


The primary objective of this review was to compare event-free (death, requirement for a cardiac transplant, or placement of a left ventricular assist device) or overall (death) survival of adults and children with presumed viral myocarditis treated with IVIG versus those who did not receive IVIG. A secondary objective was to determine if a group of patients with presumed viral myocarditis could be identified (on the basis of age, duration of symptoms, acuity of onset of symptoms, cardiac function at presentation, virological results, or the presence or absence of histological evidence of acute myocarditis on cardiac biopsy in patients in whom a biopsy was performed) who would be the most likely to benefit from IVIG.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Embase, DARE, CINAHL, Web of Science Core Collection, and LILACS in July 2019, and two trial registries in November 2019. We contacted authors of trials and checked reference lists of relevant papers. We applied no language restrictions.
SELECTION CRITERIA


We included studies if (1) participants had a clinical diagnosis of acute myocarditis with a left ventricular ejection fraction (LVEF) ≤ 0.45, left ventricular end-diastolic diameter (LVEDD) > 2 standard deviations (SDs) above the norm, or a left ventricular shortening fraction (LVSF) > 2 SDs below the mean, with duration of cardiac symptoms < 6 months; (2) participants had no evidence of non-infectious or bacterial cardiac disease; and (3) participants were randomly assigned to receive at least 1 g/kg of IVIG versus no IVIG or placebo. We excluded studies if (1) participants had received immunosuppression before outcome assessment; or (2) onset of myocarditis was reported to have occurred < 6 months postpartum.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened the search results and extracted data. We assessed risk of bias with the Cochrane 'Risk of bias' tool. We conducted meta-analysis for two outcomes (overall survival and improvement in LVEF) with two adult trials. Other meta-analyses were not possible because only three relevant trials were included, and researchers analysed markedly different populations and used different outcome measures.
MAIN RESULTS


In this update we added two trials to the two previously included trials. A quasi-randomised trial was previously included due to a paucity of evidence from randomised trials; however, with the addition of two new randomised trials, it was removed from this update. For two adult trials, the overall risk of bias was unclear with very low-certainty evidence for all outcomes. The first trial studied 62 adults with recent-onset dilated cardiomyopathy randomly assigned to receive IVIG or an equivalent volume of 0.1% albumin in a blinded fashion. The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40). The second trial studied 41 adults with acute myocarditis randomised to either high-dose IVIG (1 to 2 g/kg over two days) or no treatment. The IVIG group reported greater survival time after 60 days (no raw data, P < 0.01), but the evidence is uncertain. We pooled the reported number of deaths in both trials, with no evidence of a difference between groups (RR 0.91, 95% CI 0.23 to 3.62, I 2  = 31%, very low-certainty evidence). The evidence on the effect of IVIG treatment on LVEF (pooled mean difference (MD) -0.01, 95% CI -0.06 to 0.05) after 12 months and an unknown time frame is uncertain. The results for functional capacity, assessed by peak oxygen consumption at 12 months, were uncertain (MD -0.80, 95% CI -4.57 to 2.97). The results for infusion-related side effects were also uncertain due to a very large CI (RR 20.29, 95% CI 1.25 to 329.93). Lastly, there was uncertain evidence addressing failure to attain complete recovery (RR 0.46, 95% CI 0.19 to 1.14).  Evidence for improvement in LVEDD, left ventricular shortening fraction, and hospitalisation status in adults was not reported.  In the single included paediatric trial, the overall risk of bias was low with very low-certainty evidence for all outcomes. The trial included 86 children in Egypt presenting with acute myocarditis. Children were randomly assigned to 1 g/kg IVIG daily for two consecutive days or placebo followed by echocardiography one and six months post randomisation for recording of LVEDD and LVSF. The evidence for overall survival after six months was uncertain (risk of death RR 0.48, 95% CI 0.20 to 1.15). The evidence was also uncertain for improvement in LVEDD and LVSF after six months (LVEDD MD -4.00, 95% CI -9.52 to 1.52; LVSF no raw data).  Evidence for improvement in LVEF, functional capacity, side effects, complete recovery, and hospitalisation status in children was not reported.  AUTHORS' CONCLUSIONS: Evidence from two trials of very low certainty and with unclear risk of bias provides contradictory evidence on the use of IVIG in the treatment of adults with presumed viral myocarditis. One trial reported that use of IVIG results in longer survival time after 60 days, whilst the other trial found that IVIG does not provide an appreciable benefit. The evidence of a difference in event-free or overall survival, LVEDD, or LVSF is of very low certainty in a single paediatric trial with a low risk of bias. Until higher-quality studies with low risk of bias and larger sample sizes have demonstrated benefit in a particular group of patients, the evidence for treatment with IVIG for presumed viral myocarditis is uncertain. Further studies of the pathophysiology of myocarditis would lead to improved diagnostic criteria, which would facilitate future research.",2020,"The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40).","['1) participants had a clinical diagnosis of acute myocarditis with a left ventricular ejection fraction (LVEF) ≤ 0.45, left ventricular end-diastolic diameter (LVEDD) > 2 standard deviations (SDs) above the norm, or a left ventricular shortening fraction (LVSF', '41 adults with acute myocarditis randomised to either', '62 adults with recent-onset dilated cardiomyopathy randomly assigned to receive', 'adults and children with presumed viral myocarditis treated with IVIG versus those who did not receive IVIG', 'adults with presumed viral myocarditis', 'children and adults', ' (2) participants had no evidence of non-infectious or bacterial cardiac disease; and (3) participants', 'patients with presumed viral myocarditis could be identified (on the basis of age, duration of symptoms, acuity of onset of symptoms, cardiac function at presentation, virological results, or the presence or absence of histological evidence of acute myocarditis on cardiac biopsy in patients in whom a biopsy was performed) who would be the most likely to benefit from IVIG', '86 children in Egypt presenting with acute myocarditis']","['Intravenous immunoglobulin', 'IVIG versus no IVIG or placebo', 'IVIG or an equivalent volume of 0.1% albumin', 'intravenous immunoglobulin (IVIG', 'high-dose IVIG', 'placebo followed by echocardiography one and six months post randomisation for recording of LVEDD and LVSF']","['event-free or overall survival,\xa0LVEDD, or LVSF', 'survival time', 'peak oxygen consumption', 'longer survival time', 'event-free\xa0(death, requirement for a cardiac transplant, or placement of a left ventricular assist device) or overall (death) survival', 'LVEF, functional capacity, side effects, complete recovery, and hospitalisation status', 'LVEDD and LVSF', 'LVEDD, left ventricular shortening fraction, and hospitalisation status', 'overall survival']","[{'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0155686', 'cui_str': 'Acute myocarditis'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007193', 'cui_str': 'Dilated cardiomyopathy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0276138', 'cui_str': 'Viral myocarditis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0189784', 'cui_str': 'Biopsy of heart'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",62.0,0.639081,"The effect on event-free survival between groups was uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI) 0.48 to 6.40).","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartling', 'Affiliation': 'Department of Pediatrics and the Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Vandermeer', 'Affiliation': 'Department of Pediatrics and the Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Sebastianski', 'Affiliation': 'Pediatrics (AB SPOR Knowledge Translation Unit), University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'Manitoba Institute of Child Health, Winnipeg, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004370.pub4']
1713,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
1714,32841287,Binocular visual function after staged implantation of extended-depth-of-focus intraocular lens targeting emmetropia and -0.5 diopter: A prospective comparison.,"The prospective comparative case series aimed to evaluate the binocular uncorrected visual acuities (BUCVAs) after staged implantations of extended-depth-of-focus intraocular lenses (EDOF IOLs) targeting emmetropia and -0.5 diopter (D). Diffractive EDOF IOLs with an add power of +1.75 D were implanted in the first eyes targeting emmetropia or -0.5 D according to the patients' preferences, then the targets for the second eyes were determined 1 week or longer after the implantation. IOL powers were determined with the SRK/T formula. Consequently, the subjects were divided into 3 groups: those with emmetropia targeted bilaterally (group EE, 22 patients), those with -0.5 D targeted bilaterally (group MM, 21 patients), and those with monovision of emmetropia and -0.5 D (group EM, 21 patients). Manifest refraction spherical equivalent (MRSE), BUCVA from 0.3 to 5 meters, spectacle use, and questionnaire regarding photic symptoms and patient satisfaction were assessed 3 months postoperatively. No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65). When the EE and MM groups were assigned based on the MRSE, the EE group was better at 5 m (P = 0.005) while the MM group at 0.5 m (P = 0.031). The effect of different targeted refractions was not identified due to insufficient accuracy in the use of the SRK/T power calculation.",2020,"No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65).",[],"['extended-depth-of-focus intraocular lens targeting emmetropia and -0.5 diopter', 'extended-depth-of-focus intraocular lenses (EDOF IOLs']","['mean BUCVAs', 'photic symptoms and patient satisfaction', 'Binocular visual function', 'IOL powers', 'Manifest refraction spherical equivalent (MRSE), BUCVA from 0.3 to 5 meters, spectacle use, and questionnaire regarding photic symptoms and patient satisfaction', 'binocular uncorrected visual acuities (BUCVAs']",[],"[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",22.0,0.019775,"No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65).","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bissen-Miyajima', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0238135']
1715,32841300,"An age-adapted plyometric exercise program improves dynamic strength, jump performance and functional capacity in older men either similarly or more than traditional resistance training.","Power declines at a greater rate during ageing and is more relevant for functional deterioration than either loss of maximum strength or muscle mass. Human movement typically consists of stretch-shortening cycle action. Therefore, plyometric exercises, using an eccentric phase quickly followed by a concentric phase to optimize power production, should resemble daily function more than traditional resistance training, which primarily builds force production capacity in general. However, it is unclear whether older adults can sustain such high-impact training. This study compared the effects of plyometric exercise (PLYO) on power, force production, jump and functional performance to traditional resistance training (RT) and walking (WALK) in older men. Importantly, feasibility was investigated. Forty men (69.5 ± 3.9 years) were randomized to 12-weeks of PLYO (N = 14), RT (N = 12) or WALK (N = 14). Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance were evaluated pre- and post-intervention. One subject in RT (low back pain) and three in PLYO (2 muscle strains, 1 knee pain) dropped out. Adherence to (91.2 ± 4.4%) and acceptability of (≥ 7/10) PLYO was high. 1-RM improved more in RT (25.0 ± 10.0%) and PLYO (23.0 ± 13.6%) than in WALK (2.9 ± 13.7%) (p < 0.001). PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK and/or RT (p < 0.05). MVC improved in RT only (p = 0.028) and RFD did not improve (p > 0.05). To conclude, PLYO is beneficial over RT for improving power, jump and stair climbing performance without compromising gains in strength. This form of training seems feasible, but contains an inherent higher risk for injuries, which should be taken into account when designing programs for older adults.",2020,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","['older adults', 'Forty men (69.5 ± 3.9 years', 'older men', 'older men either similarly or more than traditional resistance training']","['PLYO', 'plyometric exercise program', 'plyometric exercises', 'WALK', 'traditional resistance training (RT) and walking (WALK', 'plyometric exercise (PLYO']","['dynamic strength, jump performance and functional capacity', 'RFD', 'power, force production, jump and functional performance', 'jump height, jump power, contraction time of jumps and stair climbing performance', 'Leg press one-repetition maximum (1-RM), leg-extensor isometric maximum voluntary contraction (MVC) and rate of force development (RFD), jump and functional performance', 'MVC improved in RT', '1-RM improved more in RT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",40.0,0.0188582,"PLYO improved more on jump height, jump power, contraction time of jumps and stair climbing performance compared to WALK","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Van Roie', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Van Driessche', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Tijs', 'Initials': 'T', 'LastName': 'Delabastita', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Vanwanseele', 'Affiliation': 'Human Movement Biomechanics Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Delecluse', 'Affiliation': 'Physical Activity, Sports and Health Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",PloS one,['10.1371/journal.pone.0237921']
1716,32844454,Clinical relevance of positive patch test reactions to lanolin: A ROAT study.,"BACKGROUND


Lanolin is often included when patch testing for common contact allergens. The clinical relevance of a positive patch test reaction to lanolin markers is, however, still a subject for debate.
OBJECTIVES


To evaluate Amerchol L101 as a marker of lanolin allergy and investigate the clinical impact of lanolin-containing moisturizers on healthy and damaged skin using the repeated open application test (ROAT).
METHODS


Twelve test subjects and 14 controls were patch tested with Amerchol L 101 and additional lanolin markers. Subsequently, a blinded ROAT was performed on the arms of the study participants for 4 weeks. Each participant applied a lanolin-free cream base and two different lanolin-containing test creams twice daily on one arm with intact skin and on the other arm with irritant dermatitis, induced by sodium lauryl sulfate (SLS).
RESULTS


Eleven test subjects (92%) had positive patch test reactions to Amerchol L 101 when retested and one test subject (8%) had a doubtful reaction. None of the study participants had any skin reactions to the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
CONCLUSIONS


Lanolin-containing emollients do not cause or worsen existing dermatitis when performing ROAT in volunteers patch test positive to Amerchol L101.",2020,"None of the study participants had any skin reactions for the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
",['Twelve test subjects and 14 controls were patch tested with Amerchol L 101 and additional lanolin markers'],"['lanolin-free cream base and two different lanolin-containing test creams twice daily on one arm with intact skin and one arm with irritant dermatitis, induced by sodium lauryl sulphate (SLS']","['positive patch test reactions', 'skin reactions']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2712179', 'cui_str': 'Intact skin'}, {'cui': 'C0162823', 'cui_str': 'Irritant contact dermatitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}]",,0.0319924,"None of the study participants had any skin reactions for the ROAT on intact skin and all participants healed during the ROAT on damaged skin.
","[{'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Uldahl', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Engfeldt', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svedman', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Skåne University Hospital, Lund University, Malmö, Sweden.'}]",Contact dermatitis,['10.1111/cod.13689']
1717,32848896,Methodological Biases in CBT Trial-Commentary: Modular Cognitive-Behavioral Therapy for Affective Symptoms in Young Individuals at Ultra-High Risk of First Episode of Psychosis: Randomized Controlled Trial.,,2020,,['Young Individuals at Ultra-High Risk of First Episode of Psychosis'],['Cognitive-Behavioral Therapy'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0628906,,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Radua', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McKenna', 'Affiliation': 'Investigación Germanes Hospitalàries Research Foundation, Barcelona, Spain.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Laws', 'Affiliation': 'Department of Psychology and Sports Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Jauhar', 'Affiliation': 'National Institute for Health Research, Maudsley Biomedical Research Centre, South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00394']
1718,32847916,Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial.,"INTRODUCTION


Falls risk poststroke is highest soon after discharge from rehabilitation. Reactive balance training (RBT) aims to improve control of reactions to prevent falling after a loss of balance. In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life. While increasing the dose of RBT does not appear to lead to additional benefit for healthy older adults, stroke survivors, who have more severely impaired balance control, may benefit from a higher RBT dose. Our long-term goal is to determine the optimal dose of RBT in people with subacute stroke. This assessor-blinded pilot randomised controlled trial aims to inform the design of a larger trial to address this long-term goal.
METHODS AND ANALYSIS


Participants (n=36) will be attending out-patient stroke rehabilitation, and will be randomly allocated to one of three groups: one, three or six RBT sessions. RBT will replace a portion of participants' regular physiotherapy so that the total physical rehabilitation time will be the same for the three groups. Balance and balance confidence will be assessed at: (1) study enrolment; (2) out-patient rehabilitation discharge; and (3) 6 months postdischarge. Participants will report falls and physical activity for 6 months postdischarge. Pilot data will be used to plan the larger trial (ie, sample size estimate using fall rates, and which groups should be included based on between-group trends in pre-to-post training effect sizes for reactive balance control measures). Pilot data will also be used to assess the feasibility of the larger trial (ie, based on the accrual rate, outcome completion rate and feasibility of prescribing specific training doses).
ETHICS AND DISSEMINATION


Institutional research ethics approval has been received. Study participants will receive a lay summary of results. We will also publish our findings in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT04219696; Pre results.",2020,"In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life.","['people with subacute stroke', 'healthy older adults, stroke survivors', 'Participants (n=36) will be attending out-patient stroke rehabilitation', 'healthy older adults']","['reactive balance training', 'Reactive balance training (RBT', 'RBT session', 'RBT']",['Balance and balance confidence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",36.0,0.211706,"In healthy older adults, a single RBT session can lead to lasting improvements in reactive balance control and prevent falls in daily life.","[{'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada avril.mansfield@uhn.ca.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Inness', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Danells', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jagroop', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Bhatt', 'Affiliation': 'Department of Physical Therapy, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Huntley', 'Affiliation': 'Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-038073']
1719,32847917,"Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol of a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial based on dual antiplatelet therapy.","INTRODUCTION


Unstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST.
METHODS AND ANALYSIS


This is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the  t  test or non-parametric statistical test. Qualitative data will be analysed using the χ 2  or Fisher exact tests, Cochran-Mantel-Hasenszel test and Wilcoxon test.
ETHICS AND DISSEMINATION


This trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION


This study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.",2020,Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS.,"['1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group', 'patients with unstable angina']","['high-dose Xueshuantong injection (lyophilised', 'Xueshuantong injection (lyophilised) (XST']","['efficacy assessment and major adverse cardiovascular events', 'Efficacy and safety', 'frequency of angina attack, angina pectoris']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1200.0,0.316559,Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS.,"[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research and Data Center, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': 'National Drug Clinical Trial Agency Office, Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weiji', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaoxiang', 'Initials': 'S', 'LastName': 'Xian', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhongqi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China yang_zhongqi@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-038074']
1720,32847918,"Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease.","INTRODUCTION


It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.
METHODS AND ANALYSIS


The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO 2 max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.
ETHICS AND DISSEMINATION


The study protocol has been approved under Australia's National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001458224).",2020,It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia.,"['people with coronary heart disease (CHD', 'people with coronary heart disease', 'people with CHD']","['Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation', 'SCRAM', 'usual care cardiac rehabilitation (UC) alone']","['incremental cost-effectiveness ratio', 'maximal oxygen uptake (VO 2 max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument', 'Productivity loss']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.17886,It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia.,"[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Victoria, Australia lan.gao@deakin.edu.au.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rawstorn', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Nossal Institute for Global Health, University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McNaughton', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lamb', 'Affiliation': 'School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': 'Cardiac Services, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Voltaire', 'Initials': 'V', 'LastName': 'Nadurata', 'Affiliation': 'Department of Cardiology, Bendigo Health, Bendigo, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Neil', 'Affiliation': 'Western Clinical School, The University of Melbourne, Saint Albans, Victoria, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Applied Artificial Intelligence Institute, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'School of Health and Social Development, Deakin University, Burwood, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038178']
1721,32847923,"Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).","INTRODUCTION


Hyperkalaemia is a common electrolyte disorder and can be life-threatening. In the emergency room (ER), interventions aim to protect patients from the immediate dangers of elevated serum potassium by redistributing potassium ions from the bloodstream into the cells via intravenous insulin or nebulised beta2-agonists. However, to date, evidence for acute management of hyperkalaemia is limited. The aim of this randomised controlled trial is therefore to compare three strategies, namely insulin/glucose intravenous infusion, nebulised salbutamol or a combination of nebulised salbutamol and insulin/glucose intravenous infusion to reduce serum potassium concentration at 60 min as a first-line treatment in patients admitted to the ER with serum potassium concentrations superior or equal to 6 mmol/L.
METHODS AND ANALYSIS


INSAKA is a prospective, multicentre, controlled, open-label, parallel-group, randomised in a 1:1:1 ratio clinical trial. Patients will be eligible for randomisation if they have serum potassium concentrations superior or equal to 6 mmol/L measured in the ER. Patients will receive either: (1) 10 mg of nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500 mL of 10% glucose combined with 10 mg of nebulised salbutamol. The primary endpoint will be the mean change in the absolute serum potassium level from baseline to 60 min measured in mmol/L. We plan to include 525 patients.
ETHICS AND DISSEMINATION


The INSAKA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. All trial documents and procedures have been reviewed and approved by the Ethics Committee Sud Méditerranée III (approval ID number: 19.07.16.36428). The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
TRIAL REGISTRATION


EudraCT number: 2019-002710-39, Clinicaltrials.gov identifier: NCT04012138.",2020,"The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
","['patients admitted to the ER with serum potassium concentrations superior or equal to 6\u2009mmol/L', 'acute hyperkalaemia in the emergency room']","['nebulised salbutamol and insulin/glucose intravenous infusion', 'nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500\u2009mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500\u2009mL of 10% glucose combined with 10\u2009mg of nebulised salbutamol', 'nebulised salbutamol', 'Insulin glucose infusion versus nebulised salbutamol', 'salbutamol and insulin glucose']","['serum potassium concentration', 'mean change in the absolute serum potassium level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0268022', 'cui_str': 'Acute hyperkalemia'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.175484,"The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.
","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Montassier', 'Affiliation': 'Department of Emergency Medicine, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nantes University Hospital, 44000-Nantes, France emmanuel.montassier@chu-nantes.fr.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Lemoine', 'Affiliation': 'Department of Emergency Medicine, Nantes University Hospital, 44000-Nantes, France.'}, {'ForeName': 'Jean Benoit', 'Initials': 'JB', 'LastName': 'Hardouin', 'Affiliation': 'SPHERE U1246, Inserm, Université de Nantes-Université de Tours, 44000-Nantes, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Institut Lorrain Du Coeur Et Des Vaisseaux Louis Mathieu, Université de Lorraine, Inserm, Centre d'Investigations Cliniques- Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Vandoeuvre-les-nancy, France.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': 'Department of Anesthesiology & Peri-operative & Critical Care Medicine, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), University of California, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039277']
1722,32852696,Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in People ≥ 65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency.,"INTRODUCTION


Older patients with type 2 diabetes (T2D) are at increased risk of diabetic nephropathy and mild renal insufficiency. This analysis compared the anti-hyperglycemic efficacy and safety of sitagliptin with dapagliflozin in patients ≥ 65 years of age with T2D and mild renal insufficiency.
METHODS


This was a post hoc analysis of data from 410 patients ≥ 65 years old who participated in a 24-week, randomized, double-blind clinical trial (CompoSIT-R [comparison of sitagliptin with dapagliflozin in mild renal impairment]; NCT02532855) in T2D patients with mild renal insufficiency and on metformin ± a sulfonylurea; the primary efficacy end point was change in HbA1c at week 24.
RESULTS


Treatment groups were well balanced at baseline (mean HbA1c = 7.7/7.7% and eGFR = 79/76 ml/min/1.73 m 2  for sitagliptin/dapagliflozin). At week 24, LS mean (95% CI) change in HbA1c and percentage of patients with HbA1c < 7% were greater with sitagliptin, - 0.48% and 41%, respectively, compared with dapagliflozin, - 0.36% and 28%; between-group differences = - 0.12% (- 0.36, 0.01) and 12.8% (3.3, 22.2) for change in HbA1c and percentage with HbA1c < 7%, respectively. The sitagliptin group had greater reductions in PPG end points, while the dapagliflozin group had greater reductions in FPG. Treatments were generally well tolerated. There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
CONCLUSIONS


In patients ≥ 65 years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin ± sulfonylurea, treatment with sitagliptin for 24 weeks resulted in improvement in HbA1c relative to treatment with dapagliflozin that is consistent with that previously observed in the overall population. Both treatments were generally well tolerated.",2020,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","['patients\u2009≥\u200965\xa0years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin\u2009±\u2009sulfonylurea, treatment with sitagliptin for 24\xa0weeks', 'T2D patients with mild renal insufficiency and on metformin\u2009±\u2009a', 'Older patients with type 2 diabetes (T2D', '65\xa0years of age with T2D and mild renal insufficiency', 'People\u2009≥', '410 patients\u2009≥', '65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency', '65\xa0years old who participated', 'patients\u2009≥']","['Sitagliptin', 'Dapagliflozin', 'sitagliptin with dapagliflozin', 'sulfonylurea', 'dapagliflozin']","['FPG', 'tolerated', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.192702,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","[{'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. annaswamy.raji@merck.com.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Raymond L H', 'Initials': 'RLH', 'LastName': 'Lam', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': ""O'Neill"", 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00907-w']
1723,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
1724,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
1725,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
1726,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
1727,32857151,Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial.,"Importance


Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking.
Objective


To determine the effectiveness of a short-term integrated palliative care (SIPC) intervention for people with LTNCs.
Design, Setting, and Participants


Multicenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services. A total of 535 patients with LTNC were assessed for eligibility and 350 were randomized. Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy. Data were analyzed from November 2018 to March 2019.
Interventions


Patients were randomized 1:1 using minimization method to receive SIPC (intervention, n = 176) or standard care (control, n = 174).
Main Outcomes and Measures


Primary outcome was change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions. Secondary outcomes included change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs. Data were collected and analyzed blindly by intention to treat.
Results


A total of 350 patients (mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n = 229). There were no between-group differences in primary outcome (effect size, -0.16; 95% CI, -0.37 to 0.05), any other patient-reported outcomes, adverse events, or survival. Although there was more symptom reduction in the SIPC group in relation to mean change in primary outcome, the difference between the groups was not statistically significant (-0.78; 95% CI, -1.29 to -0.26 vs -0.28; 95% CI, -0.82 to 0.26; P = .14). There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367 (95% CI, -$2450 to -$282) in the SIPC group and -653 (95% CI, -$1839 to -$532) in the control group, but this difference was not statistically significant (P = .12). SIPC was perceived by patients and caregivers as building resilience, attending to function and deficits, and enabling caregivers.
Conclusions and Relevance


In this study, SIPC was not statistically significantly different from standard care for the patient-reported outcomes. However, SIPC was associated with lower cost, and in qualitative analysis was well-received by patients and caregivers, and there were no safety concerns. Further research is warranted.
Trial Registration


isrctn.org Identifier: ISRCTN18337380.",2020,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"['Participants\n\n\nMulticenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services', 'Patients Severely Affected With Long-term Neurological Conditions', 'patients with long-term neurological conditions (LTNCs', '535 patients with LTNC were assessed for eligibility and 350 were randomized', 'patients with advanced cancer', 'people with LTNCs', 'Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy', 'mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n\u2009=\u2009229', '350 patients']","['SIPC (intervention, n\u2009=\u2009176) or standard care (control, n\u2009=\u2009174', 'Short-term Integrated Palliative Care', 'short-term integrated palliative care (SIPC) intervention']","['change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs', 'change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions', 'mean health and social care costs', 'symptom intensity and quality of life', 'symptom reduction', 'adverse events, or survival']","[{'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517604', 'cui_str': '174'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",535.0,0.243461,There was a decrease in mean health and social care costs from baseline to 12 weeks -$1367,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Hepgul', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Bajwah', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Crosby', 'Affiliation': 'Department of Palliative Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lindsay', 'Affiliation': 'Marlets Hospice, Hove, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'The Walton Centre NHS Foundation Trust and University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Groves', 'Affiliation': 'Queenscourt Hospice, Southport, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': ""Department of Palliative Care, Ashford and St Peter's Hospitals NHS Foundation Trust, Surrey, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burman', 'Affiliation': ""Department of Palliative Care, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'K Ray', 'Initials': 'KR', 'LastName': 'Chaudhuri', 'Affiliation': 'Parkinson Foundation International Centre of Excellence, Kings College Hospital and Kings College London, London, United Kingdom.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Silber', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Trust, London, United Kingdom.""}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.15061']
1728,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015']
1729,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
1730,32841219,Fc receptor-like 5 and anti-CD20 treatment response in granulomatosis with polyangiitis and microscopic polyangiitis.,"BACKGROUNDBaseline expression of FCRL5, a marker of naive and memory B cells, was shown to predict response to rituximab (RTX) in rheumatoid arthritis. This study investigated baseline expression of FCRL5 as a potential biomarker of clinical response to RTX in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).METHODSA previously validated quantitative PCR-based (qPCR-based) platform was used to assess FCRL5 expression in patients with GPA/MPA (RAVE trial, NCT00104299).RESULTSBaseline FCRL5 expression was significantly higher in patients achieving complete remission (CR) at 6, 12, and 18 months, independent of other clinical and serological variables, among those randomized to RTX but not cyclophosphamide-azathioprine (CYC/AZA). Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared with FCRL5lo subjects (84% versus 57% [P = 0.016], 68% versus 40% [P = 0.02], and 68% versus 29% [P = 0.0009], respectively).CONCLUSIONOur data taken together suggest that FCRL5 is a biomarker of B cell lineage associated with increased achievement and maintenance of complete remission among patients treated with RTX and warrant further investigation in a prospective manner.FUNDINGThe analysis for this study was funded by Genentech Inc.",2020,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","['granulomatosis with polyangiitis and microscopic polyangiitis', 'granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA', 'patients with GPA/MPA (RAVE trial, NCT00104299']","['RTX', 'FCRL5', 'rituximab (RTX']","['FCRL5 expression', 'Baseline FCRL5 expression', 'CR rates']","[{'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}]","[{'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.0755829,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","[{'ForeName': 'Kasia', 'Initials': 'K', 'LastName': 'Owczarczyk', 'Affiliation': ""Department of Cancer Imaging, King's College London, London, United Kingdom.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Cascino', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Holweg', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Gaik W', 'Initials': 'GW', 'LastName': 'Tew', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Ortmann', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Behrens', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Hoffmann - La Roche, Basel, Switzerland.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Cees Gm', 'Initials': 'CG', 'LastName': 'Kallenberg', 'Affiliation': 'University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Lim', 'Affiliation': 'Immune Tolerance Network (ITN), Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brunetta', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Prunotto', 'Affiliation': 'Hoffmann - La Roche, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.136180']
1731,32841256,"The efficacy of a compounded micronutrient supplement on the incidence, duration, and severity of the common cold: A pilot randomized, double-blinded, placebo-controlled trial.","PURPOSE


Viral upper respiratory infections are associated with significant health and economic impact. This study sought to determine the efficacy of routine immune system micronutrient supplementation on the incidence, duration and severity of common cold symptoms.
METHODS


This pilot study was a randomized, double-blinded, placebo-controlled trial of N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017. The treatment group received an immune system targeted micronutrient caplet, while the placebo group received a micronized cellulose caplet externally identical to the treatment caplet. Weekly surveys were sent electronically to participants to document common cold incidence, duration and severity. Primary statistical results were obtained using mixed-effects logistic regressions to account for longitudinal measurements for participants.
RESULTS


The odds of acquiring an upper respiratory infection, adjusted for potential confounders, was estimated to be 0.74 times lower in the treatment group (p = 0.14). The odds of reporting specific symptoms were statistically lower in the treatment arm compared to the placebo arm for runny nose (OR = 0.53, p = 0.01) and cough (OR = 0.51, p = 0.04). Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05). There was no significant difference in severity of symptoms in either group. The observed proportion of reported cold symptoms in the treatment group was lower compared to the placebo group between late January and February in two consecutive cold seasons. Given the physical, workplace and economic impact of upper respiratory infections, this low cost and low risk intervention should be further studied with more robust investigation and meticulous experimental design.",2020,Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05).,['N = 259 with asymptomatic participants aged 18 to 65 in two cold seasons of 2016 and 2017'],"['micronutrient supplement', 'micronized cellulose caplet externally identical to the treatment caplet', 'placebo', 'immune system targeted micronutrient caplet, while the placebo', 'routine immune system micronutrient supplementation']","['cough', 'severity of symptoms', 'incidence, duration, and severity of the common cold', 'cold symptoms', 'odds of reporting specific symptoms', 'Shorter durations of runny nose and cough']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020962', 'cui_str': 'Structure of immune system'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0863093', 'cui_str': 'Cold symptoms'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}]",2.0,0.394248,Shorter durations of runny nose and cough were also observed in the treatment arm compared to placebo (both p < 0.05).,"[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Lenhart', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Kale', 'Initials': 'K', 'LastName': 'Quackenbush', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'LaPorte', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Community Health Care Family Medicine Residency, Tacoma, Washington in affiliation with the Family Medicine Residency Network, University of Washington School of Medicine, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0237491']
1732,32841261,Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6.,"BACKGROUND/PURPOSE


To date, studies examining polymicrobial infections in ocular disease have mostly been limited to keratitis or endophthalmitis. We characterized polybacterial infections compared to monobacterial infections in prior clinical studies evaluating besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis and report on associated microbiological outcomes.
METHODS


In this post-hoc analysis, microbiological data for subjects with conjunctivitis due to one or more than one bacterial species in three previous studies (two vehicle-, one active-controlled) of besifloxacin were extracted. Bacterial species identified at baseline were deemed causative if their colony count equaled or exceeded species-specific prespecified threshold criteria. In subjects with polybacterial infections, the fold-increase over threshold was used to rank order the contribution of individual species. Baseline pathogens and their minimum inhibitory concentrations (MICs) for common ophthalmic antibiotics were compared by infection type, as were microbial eradication rates following treatment with besifloxacin.
RESULTS


Of 1041 subjects with culture-confirmed conjunctivitis, 17% had polybacterial and 83% had monobacterial conjunctivitis at baseline. In polybacterial compared to monobacterial infections, Haemophilus influenzae and Streptococcus pneumoniae were identified less frequently as the dominant infecting species (P = 0.042 and P<0.001, respectively), whereas Streptococcus mitis/S. mitis group was identified more frequently as dominant (P<0.001). Viral coinfection was also identified more frequently in polybacterial infections (P<0.001). Staphylococcus aureus was the most common coinfecting species in polybacterial infections and the second most common dominant species in such infections. With few exceptions, MICs for individual species were comparable regardless of infection type. Clinical microbial eradication rates with besifloxacin were high regardless of infection type (P≤0.016 vs vehicle at follow-up visits).
CONCLUSIONS


Approximately one in five subjects with bacterial conjunctivitis are infected with more than one bacterial species underscoring the need for a broad-spectrum antibiotic for such infections. Besifloxacin treatment resulted in robust eradication rates of these infections comparable to monobacterial infections.
TRIAL REGISTRATION


NCT000622908, NCT00347932, NCT00348348.",2020,Viral coinfection was also identified more frequently in polybacterial infections (P<0.001).,"['subjects with conjunctivitis', '1041 subjects with culture-confirmed conjunctivitis, 17% had polybacterial and 83% had monobacterial conjunctivitis at baseline']","['besifloxacin ophthalmic suspension', 'Besifloxacin', 'besifloxacin ophthalmic suspension 0.6', 'besifloxacin']","['microbial eradication rates', 'Viral coinfection']","[{'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C2700743', 'cui_str': 'besifloxacin Ophthalmic Suspension'}, {'cui': 'C2351042', 'cui_str': 'besifloxacin'}, {'cui': 'C4068883', 'cui_str': '0.6'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}]",1041.0,0.0485752,Viral coinfection was also identified more frequently in polybacterial infections (P<0.001).,"[{'ForeName': 'Heleen H', 'Initials': 'HH', 'LastName': 'DeCory', 'Affiliation': 'Medical Affairs, Bausch + Lomb, Rochester, New York, United States of America.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Sanfilippo', 'Affiliation': 'Medical Affairs, Bausch + Lomb, Rochester, New York, United States of America.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin & Associates, Rochester, New York, United States of America.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Blondeau', 'Affiliation': 'Clinical Microbiology, Royal University Hospital, Saskatoon, Saskatchewan, Canada.'}]",PloS one,['10.1371/journal.pone.0237603']
1733,32844300,Evaluating a low-fidelity inguinal canal model.,"PURPOSE


The inguinal canal anatomy is of paramount clinical significance due to the common occurrence of direct and indirect inguinal hernias. However, the inguinal canal is often an area of great difficulty for medical students to understand. The aim of this study was to evaluate the use of a low-cost, low-fidelity inguinal canal model as a teaching and learning aid.
METHODS


A low-fidelity inguinal canal model was introduced as a learning aid in an anatomy tutorial on the inguinal region. Students were randomised into intervention (n = 66) and control (n = 40) groups. Following the tutorial, all students completed a multiple-choice question quiz on the inguinal canal. The intervention group also completed a questionnaire evaluating the positive and negative aspects of the model.
RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087). Positive aspects of the model as described by the students included its simplicity and ability to improve their three-dimensional understanding of the inguinal canal. Students requested more hands-on time with the model during the tutorial.
CONCLUSION


The present study supports current literature in that low-fidelity anatomy models are a useful adjunct to aid students' learning of complex anatomical concepts. Students may benefit from creating their own inguinal canal model to retain as a personal study tool.",2020,"RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087).",[],"['low-cost, low-fidelity inguinal canal model']",[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021445', 'cui_str': 'Inguinal canal structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],,0.018199,"RESULTS


Students taught with the inguinal canal model achieved higher scores (mean: 88.31% vs 81.7%, p = 0.087).","[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Hindmarch', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia. jakehindmarch19@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Bazzi', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lahoud', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Malik', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Anatomy, The University of Notre Dame Australia, 160 Oxford Street, Darlinghurst, Sydney, NSW, 2010, Australia.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02553-0']
1734,32856298,Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.,"BACKGROUND


Oral 5-aminosalicylic acid (5-ASA; also known as mesalazine or mesalamine) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. In an earlier version of this review, we found that 5-ASA drugs were more effective than placebo for maintenance of remission of ulcerative colitis (UC), but had a significant therapeutic inferiority relative to SASP. In this version, we have rerun the search to bring the review up to date.
OBJECTIVES


To assess the efficacy, dose-responsiveness, and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for maintenance of remission in quiescent UC and to compare the efficacy and safety of once-daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens.
SEARCH METHODS


We performed a literature search for studies on 11 June 2019 using MEDLINE, Embase, and the Cochrane Library. In addition, we searched review articles and conference proceedings.
SELECTION CRITERIA


We included randomized controlled trials with a minimum treatment duration of six months. We considered studies of oral 5-ASA therapy for treatment of participants with quiescent UC compared with placebo, SASP, or other 5-ASA formulations. We also included studies that compared once-daily 5-ASA treatment with conventional dosing of 5-ASA and 5-ASA dose-ranging studies.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcome was the failure to maintain clinical or endoscopic remission. Secondary outcomes were adherence, adverse events (AE), serious adverse events (SAE), withdrawals due to AEs, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus SASP, once-daily dosing versus conventional dosing, 5-ASA (balsalazide, Pentasa, and olsalazine) versus comparator 5-ASA formulation (Asacol and Salofalk), and 5-ASA dose-ranging. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each outcome. We analyzed data on an intention-to-treat basis, and used GRADE to assess the overall certainty of the evidence.
MAIN RESULTS


The search identified 44 studies (9967 participants). Most studies were at low risk of bias. Ten studies were at high risk of bias. Seven of these studies were single-blind and three were open-label. 5-ASA is more effective than placebo for maintenance of clinical or endoscopic remission. About 37% (335/907) of 5-ASA participants relapsed at six to 12 months compared to 55% (355/648) of placebo participants (RR 0.68, 95% CI 0.61 to 0.76; 8 studies, 1555 participants; high-certainty evidence). Adherence to study medication was not reported for this comparison. SAEs were reported in 1% (6/550) of participants in the 5-ASA group compared to 2% (5/276) of participants in the placebo group at six to 12 months (RR 0.60, 95% CI 0.19 to 1.84; 3 studies, 826 participants; low-certainty evidence). There is probably little or no difference in AEs at six to 12 months' follow-up (RR 0.93, 95% CI 0.73 to 1.18; 5 studies, 1132 participants; moderate-certainty evidence). SASP is more effective than 5-ASA for maintenance of remission. About 48% (416/871) of 5-ASA participants relapsed at six to 18 months compared to 43% (336/784) of SASP participants (RR 1.14, 95% CI 1.03 to 1.27; 12 studies, 1655 participants; high-certainty evidence). Adherence to study medication and SAEs were not reported for this comparison. There is probably little or no difference in AEs at six to 12 months' follow-up (RR 1.07, 95% CI 0.82 to 1.40; 7 studies, 1138 participants; moderate-certainty evidence). There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA. About 37% (717/1939) of once-daily participants relapsed over 12 months compared to 39% (770/1971) of conventional-dosing participants (RR 0.94, 95% CI 0.88 to 1.01; 10 studies, 3910 participants; high-certainty evidence). There is probably little or no difference in medication adherence rates. About 10% (106/1152) of participants in the once-daily group failed to adhere to their medication regimen compared to 8% (84/1154) of participants in the conventional-dosing group (RR 1.18, 95% CI 0.72 to 1.93; 9 studies, 2306 participants; moderate-certainty evidence). About 3% (41/1587) of participants in the once-daily group experienced a SAE compared to 2% (35/1609) of participants in the conventional-dose group at six to 12 months (RR 1.20, 95% CI 0.77 to 1.87; moderate-certainty evidence). There is little or no difference in the incidence of AEs at six to 13 months' follow-up (RR 0.98, 95% CI 0.92 to 1.04; 8 studies, 3497 participants; high-certainty evidence). There may be little or no difference in the efficacy of different 5-ASA formulations. About 44% (158/358) of participants in the 5-ASA group relapsed at six to 18 months compared to 41% (142/349) of participants in the 5-ASA comparator group (RR 1.08, 95% CI 0.91 to 1.28; 6 studies, 707 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS


There is high-certainty evidence that 5-ASA is superior to placebo for maintenance therapy in UC. There is high-certainty evidence that 5-ASA is inferior compared to SASP. There is probably little or no difference between 5-ASA and placebo, and 5-ASA and SASP in commonly reported AEs such as flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia. Oral 5-ASA administered once daily has a similar benefit and harm profile as conventional dosing for maintenance of remission in quiescent UC.",2020,There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA.,"['participants with quiescent UC', '11 June 2019 using MEDLINE, Embase, and the Cochrane Library', 'ulcerative colitis']","['5-ASA and placebo', '5-aminosalicylic acid (5-ASA', '5-ASA', 'sulfasalazine (SASP', 'Oral 5-aminosalicylic acid', 'mesalazine or mesalamine', 'oral 5-ASA therapy', 'placebo', 'placebo, SASP, or 5-ASA comparators', 'oral 5-ASA', 'placebo, SASP', 'SASP', 'Oral 5-ASA', '5-ASA versus placebo, 5-ASA versus SASP, once-daily dosing versus conventional dosing, 5-ASA (balsalazide, Pentasa, and olsalazine) versus comparator 5-ASA formulation (Asacol and Salofalk), and 5-ASA dose-ranging']","['medication adherence rates', 'efficacy and safety', 'adherence, adverse events (AE), serious adverse events (SAE), withdrawals due to AEs, and withdrawals or exclusions after entry', 'failure to maintain clinical or endoscopic remission', 'SAE', 'clinical or endoscopic remission rates', 'remission of ulcerative colitis (UC', 'risk ratio (RR', 'SAEs', 'flatulence, abdominal pain, nausea, diarrhea, headache, and dyspepsia']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0025141', 'cui_str': 'MEDLINE'}, {'cui': 'C0023621', 'cui_str': 'Library'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C1504637', 'cui_str': 'TXN protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0052940', 'cui_str': 'balsalazide'}, {'cui': 'C0678171', 'cui_str': 'Pentasa'}, {'cui': 'C0069454', 'cui_str': 'olsalazine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0678172', 'cui_str': 'Asacol'}, {'cui': 'C4083158', 'cui_str': 'Salofalk'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}]",9967.0,0.617432,There is little or no difference in clinical or endoscopic remission rates between once-daily and conventionally dosed 5-ASA.,"[{'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD000544.pub5']
1735,32857616,Four weeks of vitamin D supplementation improves nitric oxide-mediated microvascular function in college-aged African Americans.,"Reduced nitric oxide (NO)-mediated cutaneous vasodilation, secondary to increased oxidative stress, presents in young African American (AA) compared with European American (EA) adults and may be modulated by vitamin D status. We assessed cutaneous microvascular function in 18 young, healthy (21 ± 2 yr; 9 men, 9 women) subjects before (pre, 8 AA, 10 EA) 4 wk of 2,000 IU/day oral vitamin D supplementation and in 13 subjects after (post, 7 AA, 6 EA) 4 wk of 2,000 IU/day oral vitamin D supplementation. Serum vitamin D concentrations [25(OH)D] were measured at each visit. Three intradermal microdialysis fibers placed in the ventral forearm were randomized for treatment with 10 μM Tempol, 100 μM apocynin, or lactated Ringer's solution (control). Local heating (39°C) induced cutaneous vasodilation; red cell flux was measured at each site (laser-Doppler flowmetry), and cutaneous vascular conductance (CVC = flux/MAP) was expressed as a percentage of maximum (28 mM sodium nitroprusside, +43°C) for each phase of local heating. After stable elevated blood flow was attained, 15 mM  N G -nitro-l-arginine methyl ester (l-NAME; NO synthase inhibitor) was perfused at all sites to quantify the NO contribution to cutaneous vasodilation (%NO), calculated as the difference between local heating and l-NAME plateaus. Serum [25(OH)D], the magnitude of the local heating response, and %NO were all lower in AAs versus EAs ( P  < 0.01). Tempol ( P  = 0.01), but not apocynin ( P  ≥ 0.19), improved the local heating response and %NO. Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AAs ( P  ≤ 0.04) but not in EAs ( P  ≥ 0.41). Vitamin D supplementation mitigated endothelial dysfunction, an antecedent to overt cardiovascular disease (CVD), in otherwise healthy, young AA adults. NEW & NOTEWORTHY  Endothelial dysfunction, an antecedent to overt cardiovascular disease (CVD), is observed earlier and more frequently in otherwise healthy African Americans (AAs) when compared with other ethnic groups. Vitamin D may modulate endothelial function, and darkened skin pigmentation increases risk of vitamin D deficiency. We show that 4 wk of 2,000 IU/day vitamin D supplementation improves microvascular responses to local heating in AAs. Ensuring adequate vitamin D status may mitigate development of cardiovascular dysfunction in this at-risk population.",2020,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","['college-aged African Americans', 'young African American (AA) compared to European American (EA) adults', '18 young, healthy (21±2 yr; 9 M, 9 F) subjects before (pre: 8 AA, 10 EA) and 13 subjects after (post: 7 AA, 6 EA) four weeks of 2,000']","['vitamin D supplementation', 'IU/day oral vitamin D supplementation', ""10 μM tempol, 100 μM apocynin, or lactated Ringer's (control"", 'Vitamin D supplementation']","['Serum vitamin D concentrations [25(OH)D', 'nitric oxide-mediated microvascular function', 'Serum [25(OH)D], the magnitude of the local heating response', 'serum [25(OH)D], the local heating response, and %NO in AA', 'cutaneous microvascular function', 'endothelial dysfunction', 'cutaneous vascular conductance (CVC=flux/MAP', 'Local heating (39˚C) induced cutaneous vasodilation; red cell flux', 'local heating response']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0045283', 'cui_str': 'tempol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0050465', 'cui_str': 'acetovanillone'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]",,0.051069,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","[{'ForeName': 'S Tony', 'Initials': 'ST', 'LastName': 'Wolf', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Nina G', 'Initials': 'NG', 'LastName': 'Jablonski', 'Affiliation': 'Department of Anthropology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Ferguson', 'Affiliation': 'Department of Dermatology, The Penn State Hershey Medical Group, State College, Pennsylvania.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00631.2020']
1736,32860117,The effect of breaking up prolonged sitting on paired associative stimulation-induced plasticity.,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE). This effect is attenuated in older and less active individuals. Although a single bout of exercise enhances PAS-induced plasticity in young, physically inactive adults, it is not yet known if physical activity interventions affect PAS-induced neuroplasticity in middle-aged inactive individuals. Sixteen inactive middle-aged office workers participated in a randomized cross-over design investigating how CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3 h of sitting (SIT), 3 h of sitting interrupted every 30 min by 3 min of frequent short bouts of physical activity (FPA) and 2.5 h of sitting followed by 25 min of moderate-intensity exercise (EXE). Transcranial magnetic stimulation was applied over the primary motor cortex (M1) of the dominant abductor pollicis brevis to induce recruitment curves before and 5 min and 30 min post-PAS. Linear mixed models were used to compare changes in CSE using time and condition as fixed effects and subjects as random effects. There was a main effect of time on CSE and planned within-condition comparisons showed that CSE was significantly increased from baseline to 5 min and 30 min post-PAS, in the FPA condition, with no significant changes in the SIT or EXE conditions. SICI decreased from baseline to 5 min post-PAS, but this was not related to changes in CSE. Our findings suggest that in middle-aged inactive adults, FPAs may promote corticospinal neuroplasticity. Possible mechanisms are discussed.",2020,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","['older and less active individuals', 'middle-aged inactive individuals', 'Sixteen inactive middle-aged office workers']","['CSE and short-interval intracortical inhibition (SICI) were affected by PAS preceded by 3\xa0h of sitting (SIT), 3\xa0h of sitting interrupted every 30\xa0min by 3\xa0min of frequent short bouts of physical activity (FPA) and 2.5\xa0h of sitting followed by 25\xa0min of moderate-intensity exercise (EXE', 'Paired associative stimulation (PAS', 'Transcranial magnetic stimulation']","['CSE', 'SICI']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.106179,"Paired associative stimulation (PAS) can induce plasticity in the motor cortex, as measured by changes in corticospinal excitability (CSE).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bojsen-Møller', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden. emil.bojsen.moller@gih.se.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, GIH, 11486, Stockholm, Sweden.'}]",Experimental brain research,['10.1007/s00221-020-05866-z']
1737,32865373,Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia.,"BACKGROUND


Evolocumab, a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9, is widely used in adult patients to lower low-density lipoprotein (LDL) cholesterol levels. Its effects in pediatric patients with heterozygous familial hypercholesterolemia are not known.
METHODS


We conducted a 24-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia. Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter (3.4 mmol per liter) or more and a triglyceride level of 400 mg per deciliter (4.5 mmol per liter) or less were randomly assigned in a 2:1 ratio to receive monthly subcutaneous injections of evolocumab (420 mg) or placebo. The primary end point was the percent change in LDL cholesterol level from baseline to week 24; key secondary end points were the mean percent change in LDL cholesterol level from baseline to weeks 22 and 24 and the absolute change in LDL cholesterol level from baseline to week 24.
RESULTS


A total of 157 patients underwent randomization and received evolocumab (104 patients) or placebo (53 patients). At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001). The absolute change in the LDL cholesterol level was -77.5 mg per deciliter (-2.0 mmol per liter) in the evolocumab group and -9.0 mg per deciliter (-0.2 mmol per liter) in the placebo group, for a difference of -68.6 mg per deciliter (-1.8 mmol per liter) (P<0.001). Results for all secondary lipid variables were significantly better with evolocumab than with placebo. The incidence of adverse events that occurred during the treatment period was similar in the evolocumab and placebo groups.
CONCLUSIONS


In this trial involving pediatric patients with familial hypercholesterolemia, evolocumab reduced the LDL cholesterol level and other lipid variables. (Funded by Amgen; HAUSER-RCT ClinicalTrials.gov number, NCT02392559.).",2020,"At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001).","['104 patients) or', 'adult patients to lower low-density lipoprotein (LDL) cholesterol levels', 'Pediatric Heterozygous Familial Hypercholesterolemia', '157 patients underwent randomization and received', 'pediatric patients with heterozygous familial hypercholesterolemia', 'pediatric patients with familial hypercholesterolemia', 'Patients 10 to 17 years of age who had received stable lipid-lowering treatment for at least 4 weeks before screening and who had an LDL cholesterol level of 130 mg per deciliter (3.4 mmol per liter) or more and a triglyceride level of 400 mg per deciliter (4.5 mmol per liter) or less']","['Evolocumab', 'evolocumab (420 mg) or placebo', 'placebo', 'evolocumab']","['efficacy and safety', 'incidence of adverse events', 'LDL cholesterol level']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844009', 'cui_str': '4.5'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",157.0,0.65015,"At week 24, the mean percent change from baseline in LDL cholesterol level was -44.5% in the evolocumab group and -6.2% in the placebo group, for a difference of -38.3 percentage points (P<0.001).","[{'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wiegman', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hamer', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Bridges', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bartuli', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Szamosi', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Santra', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Stefanutti', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Greber-Platzer', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Luirink', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': ""From the Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital and Hospital Israelita Albert Einstein, São Paulo (R.D.S.); Amgen, Thousand Oaks, CA (A.R., C.E.K, A.H.); the Departments of Vascular Medicine (G.K.H., J.J.P.K.) and Pediatrics (A.W., I.L.), Amsterdam UMC, Amsterdam; the Cardiology Department, Geneva University Hospital, Geneva (F.M.); the Biostatistics Department, Amgen, Cambridge (I.B.), and the Department of Clinical Inherited Metabolic Disorders, Birmingham Children's Hospital, Birmingham (S.S.) - both in the United Kingdom; the Rare Diseases and Clinical Genetics Unit, Academic Pediatric Department, Bambino Gesù Children's Hospital (A.B.), and the Department of Molecular Medicine, Umberto I Hospital, Sapienza University of Rome (C.S.), Rome; the Lipid Clinic, Department of Medicine, Centre Hospitalier Universitaire de Québec-Université Laval, Quebec (J.B.), and the Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Chicoutimi, QC (D.G.) - both in Canada; the 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary (T.S.); the Department of Internal Medicine, Centres Hospitaliers Jolimont, La Louvière, Belgium (O.S.D.); and the Division of Pediatric Pulmonology, Allergology, and Endocrinology, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (S.G.-P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019910']
1738,32842399,[Clinical effects of vacuum sealing drainage in the treatment of alkali burn wounds].,"Objective:  To preliminarily observe the clinical effects of vacuum sealing drainage (VSD) in the treatment of alkali burn wounds.  Methods:  From June 2016 to March 2020, 60 male patients with alkali burns who met the inclusion criteria and hospitalized in the Affiliated Hospital of Jiangnan University were recruited in this prospectively randomized control study. According to the random number table, silver sulfadiazine group and VSD group were both allocated with 30 patients, aged (36±8) and (35±10) years respectively; with total burn area of (7.2±2.0) % and (8.5±3.0) % total body surface area respectively. After admission, patients in silver sulfadiazine group were treated with conventional silver sulfadiazine dressing change once a day after debridement; patients in VSD group were given continuous VSD treatment after debridement, with the negative pressure setting at -10.67 kPa, and the negative pressure materials were replaced every 6 to 8 days. On treatment day 1, 4, and 7, the exudate from the wounds of patients in silver sulfadiazine group and the wound drainage fluid of patients in VSD group were collected, the pH value was measured by a portable pH meter, and the volume of exudate/drainage fluid was measured. After 7, 14, and 21 days of treatment, the wound healing rates of patients were calculated in the two groups. Before treatment and 7 days after treatment, venous blood was collected from the patients in the two groups to detect the serum level of tumor necrosis factor α (TNF-α) and interleukin 8 (IL-8). Within treatment day 14, Visual Analogue Scale was used to assess the pain score of patients in the two groups during each time of dressing change. The medical costs and discharge satisfaction scores of patients in the two groups were recorded. Data were statistically analyzed with analysis of variance for repeated measurement,  t  test, and Bonferroni correction.  Results:  (1) On treatment day 1, 4, and 7, the pH values of the drainage fluid of patients in VSD group were 9.75±0.59, 9.01±0.46, and 8.13±0.28, respectively, which were significantly higher than 9.35±0.62, 8.18±0.18, and 7.58±0.09 of exudate of patients in silver sulfadiazine group ( t =2.03, 6.80, 7.56,  P <0.05 or  P <0.01). On treatment day 1 and 4, the volumes of drainage fluid of patients in VSD group were (553±83) and (239±65) mL respectively, which were significantly higher than (440±77) and (175±49) mL of exudate of patients in silver sulfadiazine group ( t =3.44, 2.24,  P <0.05). On treatment day 7, the volume of drainage fluid of patients in VSD group was (21±8) mL, which was significantly lower than (149±44) mL of exudate of patients in silver sulfadiazine group ( t =-12.61,  P <0.01). (2) After 7, 14, and 21 days of treatment, the wound healing rates of patients in VSD group were (39±6) %, (74±10) %, and (92±3) %, respectively, which were significantly higher than (25±3) %, (59±6) %, and (77±6) % in silver sulfadiazine group ( t =7.07, 5.59, 7.09,  P <0.01). (3) Before treatment, the serum levels of TNF-α and IL-8 of patients in the two groups were similar. After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01). (4) The pain score during dressing change and medical cost of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-4.28, -7.56,  P <0.01), while the discharge satisfaction score of patients in VSD group was significantly higher than that in silver sulfadiazine group ( t =10.91,  P <0.05).  Conclusions:  The application of VSD technology in clinical alkali burn wounds can effectively promote the removal of residual lye, alleviate the further damage of lye to skin tissue, shorten the wound healing time, effectively remove inflammatory mediators, reduce the pain of dressing change, decrease the total cost of treatment, and enhance satisfaction of patient.",2020,"After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01).","['60 male patients with alkali burns who met the inclusion criteria and hospitalized in the Affiliated Hospital of Jiangnan University', 'alkali burn wounds']","['continuous VSD treatment', 'vacuum sealing drainage', 'conventional silver sulfadiazine', 'vacuum sealing drainage (VSD', 'silver sulfadiazine']","['venous blood', 'Visual Analogue Scale', 'serum levels of TNF-α and IL-8', 'serum level of tumor necrosis factor α (TNF-α) and interleukin 8 (IL-8', 'medical costs and discharge satisfaction scores', 'volume of drainage fluid', 'discharge satisfaction score', 'pain score', 'wound healing rates']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}]","[{'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",60.0,0.0278021,"After 7 days of treatment, the serum levels of TNF-α and IL-8 of patients in VSD group were significantly lower than those in silver sulfadiazine group ( t =-8.75, -8.04,  P <0.01).","[{'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Huang', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Jia', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Gu', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}, {'ForeName': 'G Z', 'Initials': 'GZ', 'LastName': 'Lyu', 'Affiliation': ""Department of Burns and Plastic Surgery, the Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital), Wuxi 214041, China.""}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20200115-00024']
1739,32845317,Large Simple Double-Blind Randomized Trials for the Rapid Assessment of the Effectiveness of COVID-19 Vaccines.,,2020,,[],['COVID-19 Vaccines'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.478567,,"[{'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, University of Munich, Munich, Germany.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa456']
1740,32843703,Naltrexone modulates contextual processing in depression.,"Context, the information surrounding an experience, can significantly alter the meaning and the affective responses to events. Yet the biological mechanisms through which context modulate experiences are not entirely understood. Here, we hypothesized that the µ-opioid system-extensively implicated in placebo effects, a clinical phenomenon thought to rely on contextual processing-modulates the effects of contextual information on emotional attributions in patients with depression. To test this hypothesis, 20 unmedicated patients with depression completed a randomized, double-blind, placebo-controlled, crossover study of one dose of 50 mg of naltrexone, or placebo immediately before completing two sessions of the Contextual Framing fMRI task. This task captures effects of valenced contextual cues (pleasant vs. unpleasant) on emotional attribution (the rating of subtle emotional faces: fearful, neutral, or happy). Behaviorally, we found that emotional attribution was significantly moderated by the interaction between contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy), compared to neutral, were more negative during unpleasant, compared to pleasant context cues. At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone. Furthermore, the effects of naltrexone on emotional attribution were partially abolished in more severely depressed patients. Our results provide insights into the molecular alterations underlying context representation in patients with depression, providing pivotal early data for future treatment studies.",2020,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","['patients with depression', '20 unmedicated patients with depression', 'depression']","['placebo', 'Naltrexone', 'naltrexone, or placebo', 'naltrexone', 'valenced contextual cues (pleasant vs. unpleasant']","[""contextual cues and subtle emotional faces, such that participants' ratings of valenced faces (fearful and happy"", 'emotional attribution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]",20.0,0.0755192,"At a neural level, context-induced blood-oxygen-level-dependent responses in the ventromedial prefrontal cortex, the dorsal anterior cingulate, the dorsolateral prefrontal cortex, and the lateral orbitofrontal cortex, significantly moderated the effects of context on emotional attribution, and were blunted by naltrexone.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mizuno', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lyew', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Karim', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Dombrovski', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. pecinam@upmc.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00809-2']
1741,32847900,Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised controlled trial.,"INTRODUCTION


Emergence delirium (ED) is a common adverse manifestation after general anaesthesia and may result in undesirable consequences. Its causes and mechanisms are diverse and complex, and it is still unavoidable in clinical work. There is a high incidence of ED after otorhinolaryngology surgery, which may result from the sudden loss of functional senses and discomfort of surgical organs. This study aims to test a non-invasive, non-drug treatment modality of nose clamping and mouth-breathing training before surgery to reduce ED.
METHODS AND ANALYSIS


This prospective randomised controlled trial (RCT) will include 200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China. Study participants will be randomly assigned in two groups with a 1:1 ratio. The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme. After surgery, we will perform a single-blinded assessment of ED occurrence with stratification. IBM SPSS Statistics V.20 statistical software will be used for statistical analyses. A X 2  test will be used to compare the two groups, and t-tests will determine the statistical significance of continuous variables.
ETHICS AND DISSEMINATION


This RCT was designed in accordance with the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Shanghai General Hospital, ID: 2019KY039.We expect to release the original data in February 2022 on the ResMan original data sharing platform (IPD sharing platform) of the China clinical trial registry, which can be viewed at the following website:http://www.medresman.org.cn/pub/cn/proj/projectshow.aspx?proj=6293.
TRIAL REGISTRATION NUMBER


ChiCTR1900024925.",2020,"The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme.","['Chinese adults', '200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China']","['functional endoscopic sinus surgery', 'preconditioning by nasal splint and mouth breathing', 'nose clamping and mouth-breathing training', 'intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention']",['IBM SPSS Statistics'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0490829', 'cui_str': 'Nasal splint'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0238190', 'cui_str': 'Inclusion body myositis'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",200.0,0.17841,"The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme.","[{'ForeName': 'Hongjiao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesiology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Zhenyuan', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Medical department, Mellon community health service center, Shanghai, China.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Yachun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Yuyu', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Pei', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China.""}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anaesthesiology, Shanghai Jiaotong University First People's Hospital, Shanghai, China lijinbaoshanghai@163.com.""}]",BMJ open,['10.1136/bmjopen-2019-033803']
1742,32847902,Smartphone-delivered self-management for first-episode psychosis: the ARIES feasibility randomised controlled trial.,"OBJECTIVES


To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
DESIGN


A two-arm unblinded feasibility RCT.
SETTING


Six NHS EIP services in England.
PARTICIPANTS


Adults using EIP services who own an Android Smartphone. Participants were recruited until the recruitment target was met (n=40).
INTERVENTIONS


Participants were randomised with a 1:1 allocation to one of two conditions: (1) treatment as usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone. My Journey 3 features a range of self-management components including access to digital recovery and relapse prevention plans, medication tracking and symptom monitoring. My Journey 3 use was at the users' discretion and was supported by EIP service clinicians. Participants had access for a median of 38.1 weeks.
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes included recruitment, follow-up rates and intervention engagement. Participant data on mental health outcomes were collected from clinical records and from research assessments at baseline, 4 months and 12 months.
RESULTS


83% and 75% of participants were retained in the trial at the 4-month and 12-month assessments. All treatment group participants had access to My Journey 3 during the trial, but technical difficulties caused delays in ensuring timely access to the intervention. The median number of My Journey 3 uses was 16.5 (IQR 8.5 to 23) and median total minutes spent using My Journey 3 was 26.8 (IQR 18.3 to 57.3). No serious adverse events were reported.
CONCLUSIONS


Recruitment and retention were feasible. Within a trial context, My Journey 3 could be successfully delivered to adults using EIP services, but with relatively low usage rates. Further evaluation of the intervention in a larger trial may be warranted, but should include attention to implementation.
TRIAL REGISTRATION


ISRCTN10004994.",2020,"To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
","['Early Intervention in Psychosis (EIP) services', 'Participants were recruited until the recruitment target was met (n=40', 'Adults using EIP services who own an Android Smartphone', 'first-episode psychosis', 'Six NHS EIP services in England']","['usual from EIP services (TAU) or (2) TAU plus access to My Journey 3 on their own Smartphone', 'Smartphone-based self-management tool', 'Smartphone-delivered self-management']","['median number of My Journey', 'recruitment, follow-up rates and intervention engagement', 'serious adverse events', 'median total minutes spent']","[{'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1272289', 'cui_str': 'Early intervention in psychosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.220355,"To test the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate a Smartphone-based self-management tool in Early Intervention in Psychosis (EIP) services.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steare', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Puffin', 'Initials': 'P', 'LastName': ""O'Hanlon"", 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eskinazi', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rostill', 'Affiliation': 'University of Surrey, Guildford, Surrey, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amani', 'Affiliation': 'Early Intervention in Psychosis Programme (South of England), Oxford, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK s.johnson@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034927']
1743,32847912,"Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study.","INTRODUCTION


The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
METHODS AND ANALYSIS


The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m 2 ) and prediabetes (glycated haemoglobin 39-47 mmol/mol); or (2) obesity (BMI≥30 kg/m 2 ) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. Testing is scheduled at baseline and after 6 weeks (mid-intervention), 3 months (post-intervention) and 6 months (follow-up). The primary outcome is change in body weight after 3 months of intervention. Secondary outcomes include changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation. Motivation and feasibility will be examined based on interviews at baseline and after 3 months. After the 3-month intervention, a 3-month follow-up period and subsequent testing are scheduled to assess maintenance and longer-term effects.
ETHICS AND DISSEMINATION


The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-18059188) and the Danish Data Protection Agency. The study will be conducted in accordance with the Declaration of Helsinki. Results from the study will address whether TRE is effective and feasible in improving health outcomes in individuals at risk of lifestyle-related diseases and can potentially inform the design of feasible health recommendations.
TRIAL REGISTRATION NUMBER


NCT03854656.",2020,"The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
","['100 women and men with (1) overweight (body mass index (BMI)≥25\u2009kg/m 2 ) and prediabetes (glycated haemoglobin 39-47\u2009mmol/mol); or (2) obesity (BMI≥30\u2009kg/m 2 ', 'individuals at high risk of type 2 diabetes']","['control group (habitual living) or TRE (self-selected 10-hours eating window', 'time-restricted eating (TRE', 'TRE']","['change in body weight', 'health outcomes', 'changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation', 'body weight, behaviour and metabolism']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0751973', 'cui_str': 'Proteomes'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",100.0,0.0958709,"The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.
","[{'ForeName': 'Jonas S', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark jonas.salling.quist@regionh.dk.'}, {'ForeName': 'Marie M', 'Initials': 'MM', 'LastName': 'Jensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Bjerre', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Størling', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe S', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-037166']
1744,32852531,Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.,"Importance


Novel approaches are needed to improve outcomes in patients with squamous cell carcinoma of the oral cavity. Neoadjuvant immunotherapy given prior to surgery and combining programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitors are 2 strategies to enhance antitumor immune responses that could be of benefit.
Design, Setting, and Participants


In this randomized phase 2 clinical trial conducted at 1 academic center, 29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019.
Interventions


Treatment was administered with nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab, 1 mg/kg, given week 1 only). Patients had surgery 3 to 7 days following cycle 2.
Main Outcomes and Measures


Safety and volumetric response determined using bidirectional measurements. Secondary end points included pathologic and objective response, progression-free survival (PFS), and overall survival. Multiplex immunofluorescence was used to evaluate primary tumor immune markers.
Results


Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38%]). The most common subsite was oral tongue (n = 16). Baseline clinical staging included patients with T2 (n = 20) or greater (n = 9) T stage and 17 patients (59%) with node-positive disease. Median time from cycle 1 to surgery was 19 days (range, 7-21 days); there were no surgical delays. There were toxic effects at least possibly related to study treatment in 21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients. One patient died of conditions thought unrelated to study treatment (postoperative flap failure, stroke). There was evidence of response in both the N and N+I arms (volumetric response 50%, 53%; pathologic downstaging 53%, 69%; RECIST response 13%, 38%; and pathologic response 54%, 73%, respectively). Four patients had major/complete pathologic response greater than 90% (N, n = 1; N+I, n = 3). With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
Conclusions and Relevance


Treatment with N and N+I was feasible prior to surgical resection. We observed promising rates of response in both arms, supporting further neoadjuvant studies with these agents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02919683.",2020,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","['patients with T2 (n\u2009=\u200920) or greater (n\u2009=\u20099) T stage and 17 patients (59%) with node-positive disease', 'Untreated Oral Cavity Squamous Cell Carcinoma', '29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019', 'patients with squamous cell carcinoma of the oral cavity', 'Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38', '21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients']","['Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab', 'Neoadjuvant immunotherapy', 'nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab']","['1-year progression-free survival', 'complete pathologic response', 'overall survival', 'Median time', 'pathologic and objective response, progression-free survival (PFS), and overall survival', 'Measures\n\n\nSafety and volumetric response determined using bidirectional measurements', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",14.0,0.271878,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vickie Y', 'Initials': 'VY', 'LastName': 'Jo', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Rawal', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Catalano', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lako', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Ciantra', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Weirather', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Criscitiello', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Luoma', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chau', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Lorch', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Kass', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Annino', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goguen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Beth-Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Hina J', 'Initials': 'HJ', 'LastName': 'Shah', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Wucherpfennig', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Rodig', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Uppaluri', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA oncology,['10.1001/jamaoncol.2020.2955']
1745,32853281,Auricular stimulation vs. expressive writing for exam anxiety in medical students - A randomized crossover investigation.,"OBJECTIVE


Auricular stimulation (AS) is a promising method in the treatment of situational anxiety. Expressive writing (EW) is an established psychological method, which reduces test anxiety and improves exam results. The aim of this crossover trial was to compare AS with EW, and with the no intervention (NI) condition, for treatment of exam anxiety.
METHODS


Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized. AS was applied using indwelling fixed needles bilaterally at the areas innervated mostly by the auricular branch of the vagal nerve on the day before the exam. Anxiety level, measured using State-Trait-Anxiety Inventory (STAI) before and after the interventions and immediately before exam, was the primary outcome. Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA) were analyzed across 3 conditions.
RESULTS


All 37 included participants completed the study. Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam. After EW and NI anxiety increased on the day of exam in comparison with baseline (P<0.01). Quality of sleep improved after AS in comparison with both control conditions (P<0.01). The activity of sAA decreased after EW and after AS (P<0.05) but not after NI condition.
CONCLUSION


Auricular stimulation, but not expressive writing, reduced exam anxiety and improved quality of sleep in medical students. These changes might be due to reduced activity of the sympathetic nervous system.",2020,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"['All 37 included participants completed the study', 'Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized', 'medical students']","['Auricular stimulation vs. expressive writing', 'Auricular stimulation (AS', 'Expressive writing (EW']","['Quality of sleep', 'activity of sAA', 'Anxiety level, measured using State-Trait-Anxiety Inventory (STAI', 'Anxiety level (STAI', 'Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA', 'NI anxiety', 'expressive writing, reduced exam anxiety and improved quality of sleep']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",37.0,0.023505,Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam.,"[{'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Usichenko', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Klausenitz', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Petersmann', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesse', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Neumann', 'Affiliation': 'Institute of Diagnostic Radiology and Neuroradiology, Functional Imaging Unit, University Medicine of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hahnenkamp', 'Affiliation': 'Department of Anesthesiology, University Medicine of Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0238307']
1746,32854060,Anti-caries effect of fluoridated milk-based drink consumed by older adults on an in vitro root caries experimental model.,"OBJECTIVE


This study aimed to evaluate the anti-caries effect of a fluoridated milk-based drink on a root caries model by assessing mineral loss and both biofilm microbial viability and acidogenicity under increasing concentrations of fluoride supplementation.
DESIGN


Streptococcus mutans UA159 biofilms were grown on root dentin slabs for five days. The slabs were randomly assigned to following groups: milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10 ppm NaF (G3), and 20 ppm NaF (G4). A 10% sucrose and 0.9% NaCl solution were used as positive and negative-caries controls, respectively. Slabs/biofilms were exposed to the different treatments 3 times/day for 5 min. To estimate biofilm acidogenicity, the pH of the spent media was serially measured to calculate the area above the curve. Viable bacteria and dentin demineralization were assessed after the experimental phase. Results were compared using ANOVA followed by the Tukey test.
RESULTS


G1 exhibited slightly lower acidogenicity than the positive caries control group (p < 0.05). G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink. The lowest acidogenicity was found in G4 (p < 0.05). Fluoride-supplemented milk-based drinks (G2, G3, and G4) resulted in lower bacterial counts (p < 0.05) and induced lower demineralization (p < 0.05) than the positive caries control and non-supplemented milk-beverage (G1). There was a dose-dependent inhibition of demineralization with fluoride-supplemented milk-based drinks.
CONCLUSIONS


Fluoride supplementation of a milk-based drink for older adults may reduce its cariogenicity in root dentin.",2020,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","['older adults on an in vitro root caries experimental model', 'older adults']","['Fluoride supplementation', 'Fluoride-supplemented milk-based drinks (G2, G3, and G4', 'fluoridated milk-based drink', 'milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10\u202fppm NaF (G3), and 20\u202fppm NaF (G4']","['lower bacterial counts', 'Viable bacteria and dentin demineralization', 'acidogenicity', 'lowest acidogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C0086272', 'cui_str': 'Experimental Models'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3541971', 'cui_str': 'Fluoride supplement'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}]",,0.0182389,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Castro', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maltz', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil. Electronic address: marisa.maltz@gmail.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Arthur', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Giacaman', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104878']
1747,32855064,"Corrigendum to 'Live birth rates with a freeze-only strategy versus fresh embryo transfer: secondary analysis of a randomized clinical trial' [Reproductive BioMedicine Online, Volume 38, Issue 3, March 2019, Pages 387-396].",,2020,,[],['freeze-only strategy versus fresh embryo transfer'],[],[],"[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",[],,0.145478,,"[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: lanvuong@ump.edu.vn.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'The Robinson Research Institute, School of Medicine, Adelaide, Australia; Fertility SA, Adelaide, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.011']
1748,32859661,Feasibility and acceptability of a dietary intervention study to reduce salt intake and increase high-nitrate vegetable consumption among middle-aged and older Malaysian adults with elevated blood pressure: a study protocol.,"INTRODUCTION


Global population ageing is one of the key factors linked to the projected rise of dementia incidence. Hence, there is a clear need to identify strategies to overcome this expected health burden and have a meaningful impact on populations' health worldwide. Current evidence supports the role of modifiable dietary and lifestyle risk factors in reducing the risk of dementia. In South-East Asia, changes in eating and lifestyle patterns under the influence of westernised habits have resulted in significant increases in the prevalence of metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs). Low vegetable consumption and high sodium intake have been identified as key contributors to the increased prevalence of NCDs in these countries. Therefore, nutritional and lifestyle strategies targeting these dietary risk factors are warranted. The overall objective of this randomised feasibility trial is to demonstrate the acceptability of a dietary intervention to increase the consumption of high-nitrate green leafy vegetables and reduce salt intake over 6 months among Malaysian adults with raised blood pressure.
METHODS AND ANALYSIS


Primary outcomes focus on feasibility measures of recruitment, retention, implementation and acceptability of the intervention. Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed). Adherence to the dietary intervention will be assessed through collection of biological samples, 24-hour recall and Food Frequency Questionnaire. A subgroup of participants will also complete postintervention focus groups to further explore the feasibility considerations of executing a larger trial, the ability of these individuals to make dietary changes and the barriers and facilitators associated with implementing these changes.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Monash University Human Research Ethics Committee and Medical Research and Ethics Committee of Malaysia. Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.ISRCTN47562685; Pre-results.",2020,"Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed).","['Malaysian adults with raised blood pressure', 'middle-aged and older Malaysian adults with elevated blood pressure']",['dietary intervention'],"['prevalence of metabolic, cardiovascular and neurodegenerative non-communicable diseases (NCDs', 'blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed', 'feasibility measures of recruitment, retention, implementation and acceptability of the intervention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0453725,"Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGrattan', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK Andrea.McGrattan@Newcastle.ac.uk.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Mohan', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Pei Wei', 'Initials': 'PW', 'LastName': 'Chua', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Azizah', 'Initials': 'A', 'LastName': 'Mat Hussin', 'Affiliation': 'Kampus Cawangan Institute of Medical Science Technology, Universiti Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Yee Chang', 'Initials': 'YC', 'LastName': 'Soh', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Mawada', 'Initials': 'M', 'LastName': 'Alawad', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Bin Kassim', 'Affiliation': 'District Health Office, Pejabat Kesihatan Daerah (PKD) Segamat, Segamat, Johor, Malaysia.'}, {'ForeName': 'Ahmad Nizal', 'Initials': 'AN', 'LastName': 'Bin Mohd Ghazali', 'Affiliation': 'District Health Office, Pejabat Kesihatan Daerah (PKD) Segamat, Segamat, Johor, Malaysia.'}, {'ForeName': 'Blossom', 'Initials': 'B', 'LastName': 'Stephan', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Allotey', 'Affiliation': 'Global Public Health. Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Reidpath', 'Affiliation': 'South East Asia Community Observatory (SEACO), Monash University Malaysia, Segamat, Johor, Malaysia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035453']
1749,32859662,"Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG).","OBJECTIVES


The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.
DESIGN


YonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.
PARTICIPANTS


Six hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.
RESULTS


After 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: -2.4, 95% CI: -9.2 to 4.5) as compared with CA (ΔFACT-G total score: -3.9; 95% CI:-11.3 to 3.5; p = 0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.
CONCLUSION


Our data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier (NCT02204111).",2020,"Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110).","['Six hospitals', 'Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set', 'patients with soft tissue sarcoma undergoing treatment with', 'patients with advanced STS undergoing treatment with', 'advanced soft tissue sarcoma (STS']","['tailored multistep intervention', 'trabectedin', 'tailored palliative care intervention']","['change of Functional Assessment for Cancer Therapy (FACT-G) total score', 'QoL, symptoms and survival', 'efficacy, quality of life (QoL) and toxicity', 'Overall mean survival', 'QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment', 'symptom severity, symptom interference, depression and anxiety', 'Quality of life and added value', 'MDASI, FAACT, HADS and BPI scales']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",79.0,0.215055,"Overall mean survival was longer in IA (648 days) than in CA (389 days, p = 0.110).","[{'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Hentschel', 'Affiliation': 'Department of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany Leopold.Hentschel@uniklinikum-dresden.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Interdisciplinary Center for Soft-Tissue-Sarcoma, GIST and Bone-Tumor, Robert-Bosch-Center of Tumor Diseases, Stuttgart, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Kasper', 'Affiliation': 'Sarcoma Unit, Interdisciplinary Tumor Center, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Kunitz', 'Affiliation': 'Internal Medicine, Vivantes Clinic Spandau, Berlin, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology/West-German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Hematology Oncology, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Jens Marcus', 'Initials': 'JM', 'LastName': 'Chemnitz', 'Affiliation': 'Internal Medicine, ev. Stift St. Martin, Koblenz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology, Charité Medical University, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schuler', 'Affiliation': 'University Palliative Center, University Hospital Carl Gustav Carus, Dresden, Sachsen, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Freitag', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schilling', 'Affiliation': 'Department of Social Work, University Hospital Carl Gustav Carus, Dresden, Sachsen, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Hornemann', 'Affiliation': 'Department of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Arndt', 'Affiliation': 'Patient Advocacy, Das Lebenshaus e.V, Wölfersheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Markus Kajo', 'Initials': 'MK', 'LastName': 'Schuler', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035546']
1750,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
1751,32866967,Sustained Maternal Hyperandrogenism During PCOS Pregnancy Reduced by Metformin in Non-obese Women Carrying a Male Fetus.,"CONTEXT


Large, longitudinal studies on androgen levels in pregnant women with polycystic ovary syndrome (PCOS) are lacking. While metformin has a mild androgen-lowering effect in non-pregnant women with PCOS, its effects on maternal androgen levels in pregnancy are less well understood.
OBJECTIVE


To describe androgen patterns in pregnant women with PCOS and in healthy control women, and to explore the potential effects of metformin on maternal androgen levels in PCOS.
DESIGN AND SETTING


A post hoc analysis from a randomized, placebo-controlled, multicenter study carried out at 11 secondary care centers and a longitudinal single-center study on healthy pregnant women in Norway.
PARTICIPANTS


A total of 262 women with PCOS and 119 controls.
INTERVENTION


The participants with PCOS were randomly assigned to metformin (2 g daily) or placebo, from first trimester to delivery.
MAIN OUTCOME MEASURES


Androstenedione (A4), testosterone (T), sex-hormone binding globulin (SHBG), and free testosterone index (FTI) at 4 time points in pregnancy.
RESULTS


Women with PCOS versus healthy controls had higher A4, T, and FTI, and lower SHBG at all measured time points in pregnancy. In the overall cohort of women with PCOS, metformin had no effect on A4, T, SHBG, and FTI. In subgroup analyses, metformin reduced A4 (P = 0.019) in nonobese women. Metformin also reduced A4 (P = 0.036), T (P = 0.023), and SHBG (P = 0.010) levels through pregnancy in mothers with a male fetus.
CONCLUSION


Metformin had no effect on maternal androgens in PCOS pregnancies. In subgroup analyses, a modest androgen-lowering effect was observed in nonobese women with PCOS. In PCOS women carrying a male fetus, metformin exhibited an androgen-lowering effect.",2020,"Metformin also reduced A4 (p=0.036), T (p=0.023) and SHBG (p=0.010) levels through pregnancy in mothers with a male foetus.
","['pregnant women with PCOS, and healthy control women', '11 secondary care centers and a longitudinal single-center study on healthy pregnant women in Norway', 'mothers with a male foetus', 'pregnant women with polycystic ovary syndrome (PCOS', 'non-obese pregnant women with PCOS', '262 women with PCOS, and 119 controls', 'Women with PCOS vs. healthy controls', 'healthy pregnant women', 'non-obese women carrying a male foetus', 'participants with PCOS']","['placebo', 'metformin', 'Metformin']","['maternal androgens', 'A4, T, SHBG and FTI', 'androstenedione levels', 'SHBG', 'modest androgen-lowering effect', 'androstenedione and testosterone levels', 'higher A4, T and FTI, and lower SHBG', 'Androstenedione (A4), testosterone (T), sex-hormone binding globulin (SHBG) and free-testosterone-index (FTI', 'maternal androgen levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Center'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337432', 'cui_str': 'Androstenedione measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}]",262.0,0.315689,"Metformin also reduced A4 (p=0.036), T (p=0.023) and SHBG (p=0.010) levels through pregnancy in mothers with a male foetus.
","[{'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Andræ', 'Affiliation': 'Department of Obstetrics and Gynecology, Nordlandssykehuset, Bodø, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Abbott', 'Affiliation': 'Wisconsin National Primate Research Centre, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Solhild', 'Initials': 'S', 'LastName': 'Stridsklev', 'Affiliation': 'Department of Obstetrics and Gynecology, St Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Anne Vibeke', 'Initials': 'AV', 'LastName': 'Schmedes', 'Affiliation': 'Biochemistry and Immunology, Lillebælt Hospital, Vejle, Denmark.'}, {'ForeName': 'Ingrid Hov', 'Initials': 'IH', 'LastName': 'Odsæter', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': 'Department of Obstetrics and Gynecology, St Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa605']
1752,32869224,Comparison of Canal Transportation and Centering Ability of ProGlider and WaveOne Gold Glider in Curved Canals.,"OBJECTIVES


The aim of this study was to compare the volume variation and maintenance of the root canal position when using the ProGlider 16.02 (PG) and the WaveOne Gold Glider 15.02 (WOGG) file systems for glide path preparation.
MATERIALS AND METHODS


Twenty-four moderately curved mesiobuccal canals of maxil-lary first molars were selected and randomly divided into two groups: PG and WOGG. The selected teeth were scanned using microtomography before and after root canal preparation to assess centralization and linear transport at 1, 3, 5, and 7 mm from the apical foramen.
STATISTICAL ANALYSIS


The data were analyzed with the Mann-Whitney U test. The level of significance was 5%.
RESULTS


There were no significant differences in volume variation or root canal transport ( p  > 0.05). There was a significant difference in the centralization of the root canal at 3 mm from the foramen ( p  < 0.05).
CONCLUSIONS


WOGG and PG instruments presented similar results regarding the root canal volume increase and transport. WOGG caused higher decentralization at 3 mm from the apical foramen.",2020,There were no significant differences in volume variation or root canal transport ( p  > 0.05).,"['Twenty-four moderately curved mesiobuccal canals of maxil-lary first molars', 'Curved Canals']",['PG and WOGG'],"['root canal volume increase and transport', 'volume variation or root canal transport', 'centralization of the root canal', 'volume variation and maintenance of the root canal position']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0336863', 'cui_str': 'Glider'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",24.0,0.0392273,There were no significant differences in volume variation or root canal transport ( p  > 0.05).,"[{'ForeName': 'Gabriela Behne', 'Initials': 'GB', 'LastName': 'Miró', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Flávia Sens Fagundes', 'Initials': 'FSF', 'LastName': 'Tomazinho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Pelisser', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Mariana Maciel Batista', 'Initials': 'MMB', 'LastName': 'Borges', 'Affiliation': 'Department of Dentistry, Endodontics and Dental Materials, Bauru Dental School, Universidade de São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Marco Antônio Hungaro', 'Initials': 'MAH', 'LastName': 'Duarte', 'Affiliation': 'Department of Dentistry, Endodontics and Dental Materials, Bauru Dental School, Universidade de São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Ricci', 'Initials': 'RR', 'LastName': 'Vivan', 'Affiliation': 'Department of Dentistry, Endodontics and Dental Materials, Bauru Dental School, Universidade de São Paulo, Bauru, São Paulo, Brazil.'}, {'ForeName': 'Flares', 'Initials': 'F', 'LastName': 'Baratto-Filho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}]",European journal of dentistry,['10.1055/s-0040-1715780']
1753,32869576,"[Clinical observation of the therapeutic effect on posterior circulation ischemic vertigo treated with "" xiao xingnao kaiqiao "" acupuncture].","OBJECTIVE


To observe the short-term and long-term clinical effect on posterior circulation ischemic vertigo treated with "" xiao xingnao kaiqiao "" acupuncture (minor regaining consciousness and opening orifice) and explore its effect mechanism.
METHODS


Ninety patients with posterior circulation ischemic vertigo were randomly divided into a treatment group and a control group, 45 cases in each group. The patients of the two groups were all treated on the base of neurological medicine. In the control group, Flunarizine Hydrochloride was prescribed for oral administration (5 mg, once daily, for 21 days totally). In the treatment group, acupuncture of "" xiao xingnao kaiqiao "" was provided at Yintang (EX-HN3), bilateral Neiguan (PC6), bilateral Sanyinjiao (SP6), Baihui (GV20), bilateral Fengchi (GB20), bilateral Wangu (GB12) and bilateral Tianzhu (BL10). The needles were retained for 30 min, once daily for 21 days totally. The changes in vertigo score of traditional Chinese medicine (TCM) were observed, and the changes in the mean blood velocity (Vm) of the left vertebral artery (LVA), the right vertebral artery (RVA) and the basilar artery (BA) as well as the vascular pulsatility index (PI) were monitored and determined by transcranial Doppler (TCD). Additionally, the recurrence rate was followed up after 3 months to evaluate the long-term clinical effects.
RESULTS


After treatment, the total effective rate of the treatment group was 91.11% (41/45) and 75.56% (34/45) in the control group. The total effective rate in the treatment group was higher than that in the control group ( P <0.05). Compared with their own pre-treatment, the vertigo scores of TCM were reduced in either the treatment group or the control group after treatment ( P <0.05) and the score in the treatment group was lower than that in the control group ( P <0.05). Compared with their own pre-treatment, Vm and PI were all improved after treatment in either group (P < 0.05). After treatment, the improvements in Vm and PI of LVA、RVA and BA in the treatment group were better than those in the control group ( P <0.05). In the follow-up after 3 months, the recurrence rate was 19.51% (8/41) in the treatment group and was 50.00% (17/34) in the control group. The recurrence rate in the treatment group was lower than that in the control group ( P <0.05).
CONCLUSION


"" Xiao xingnao kaiqiao "" acupuncture obviously relieves the clinical symptoms of posterior circulation ischemic vertigo. The mechanism of acupuncture is potentially related with its effects in improving Vm and PI of LVA,RVA and BA, as well as improving blood supply of brain tissue.",2020,The total effective rate in the treatment group was higher than that in the control group ( P <0.05).,"['posterior circulation ischemic vertigo treated with', 'Ninety patients with posterior circulation ischemic vertigo']","[' xiao xingnao kaiqiao "" acupuncture', 'Flunarizine Hydrochloride', 'acupuncture of "" xiao xingnao kaiqiao "" was provided at Yintang (EX-HN3), bilateral Neiguan (PC6), bilateral Sanyinjiao (SP6), Baihui (GV20), bilateral Fengchi (GB20), bilateral Wangu (GB12) and bilateral Tianzhu (BL10', 'acupuncture', ' Xiao xingnao kaiqiao "" acupuncture']","['vertigo scores of TCM', 'vascular pulsatility index (PI', 'vertigo score of traditional Chinese medicine (TCM', 'total effective rate', 'Vm and PI of LVA、RVA and BA', 'mean blood velocity (Vm) of the left vertebral artery (LVA), the right vertebral artery (RVA) and the basilar artery (BA', 'recurrence rate']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282181', 'cui_str': 'Flunarizine hydrochloride'}, {'cui': 'C0450834', 'cui_str': 'Yintang'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0450604', 'cui_str': 'BL10'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0004811', 'cui_str': 'Structure of basilar artery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0226231', 'cui_str': 'Structure of left vertebral artery'}, {'cui': 'C0226230', 'cui_str': 'Structure of right vertebral artery'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",90.0,0.0209265,The total effective rate in the treatment group was higher than that in the control group ( P <0.05).,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changzhou Hospital Affiliated to Nanjing University of Chinese Medicine, Changzhou 213000, Jiangsu Province, China.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changzhou Hospital Affiliated to Nanjing University of Chinese Medicine, Changzhou 213000, Jiangsu Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Ni', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190771']
1754,32869937,Postactivation performance enhancement: Does conditioning one arm augment performance in the other?,"The purpose was to determine whether postactivation performance enhancement is specific to the muscle being conditioned or if it is also observed within the homologous muscles of the contralateral limb (after accounting for the warm-up and random error). We also investigated whether this differed based on training status or muscle size. One hundred seven participants (75 untrained; 32 trained) participated in four sessions. Visit 1 included baseline measurements and familiarization. Visits 2-4 included the completion of one of the three experimental conditions: (a) control, (b) same side and (c) crossover completed in a randomized order. The control condition completed all testing except for the conditioning contraction. The same side condition completed the conditioning contraction on the same side as the strength test. The crossover condition completed the conditioning on the arm opposite to the strength test. The variable of interest was the change from baseline in isokinetic strength. Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favoured the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained]. We found no relationship between muscle size and postactivation performance enhancement. In conclusion, there is an influence of training status pertaining to the postactivation performance enhancement effect but no influence from baseline muscle size. It appears unlikely that the effect is due to a systemic mechanism.",2020,"Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favored the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained].",['One hundred seven participants (75 untrained; 32 trained) participated in four sessions'],[],[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",[],[],107.0,0.0336778,"Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favored the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained].","[{'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bell', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Spitz', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Viana', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Raksha N', 'Initials': 'RN', 'LastName': 'Chatakondi', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12659']
1755,32851713,Percutaneous nephrostomy versus JJ ureteric stent as the initial drainage method in kidney stone patients presenting with acute kidney injury: A prospective randomized study.,"OBJECTIVE


To compare percutaneous nephrostomy tube versus JJ stent as an initial urinary drainage procedure in kidney stone patients presenting with acute kidney injury.
METHODS


Between January 2017 and January 2019, 143 patients with acute kidney injury secondary to obstructive kidney stone were prospectively randomized into the percutaneous nephrostomy tube group (71 patients) and JJ stent group (72 patients) at Beni-Suef University Hospital, Beni-Suef, Egypt. Exclusion criteria included candidates for acute dialysis, fever (>38°C), pyonephrosis, pregnancy and uncontrolled coagulopathy. The period required for serum creatinine normalization, failure of insertion, operative and fluoroscopy time were recorded. Definitive stone management for proximal ureteral stones >1.5 cm consisted of percutaneous nephrolithotomy for the percutaneous nephrostomy group and ureteroscopic laser lithotripsy for the JJ stent group. For stone size <1.5 cm, ureteroscopy or shockwave lithotripsy was carried out for both groups. Percutaneous nephrolithotomy was carried out for renal stones >2 cm, and shockwave lithotripsy for stones <2 cm. Distal and mid ureteral stones were treated by ureteroscopy.
RESULTS


The percutaneous nephrostomy group had shorter operative time (P = 0.001). There was no significant difference in the recovery period for normalization of serum creatinine between both groups (P = 0.120). Procedural failure, ureteric mucosal injury and perforations increased in the case of male sex, stone size >1.5 cm and upper ureteric stones in the JJ stent group. Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group. Suprapubic pain, urethral pain and lower urinary tract symptoms were significant in the JJ stent group. The presence of a JJ stent directed us toward ureteroscopy (P = 0.002) and the presence of a percutaneous nephrostomy directed us toward percutaneous nephrolithotomy (P = 0.001).
CONCLUSIONS


Percutaneous nephrostomy facilitates subsequent percutaneous nephrolithotomy, especially when carried out by a urologist, and it has a higher insertion success rate, a shorter operative time and a lesser incidence of postoperative urinary tract infection than a JJ stent. A JJ stent facilitates subsequent ureteroscopy, but operative complications can increase in the case of proximal ureteral stones >1.5 cm.",2020,"Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group.","['Between January 2017 and January 2019, 143 patients with acute kidney injury secondary to obstructive kidney stone', 'Exclusion criteria included candidates for acute dialysis, fever (>38°C), pyonephrosis, pregnancy and uncontrolled coagulopathy', 'kidney stone patients presenting with acute kidney injury', 'group (72 patients) at Beni-Suef University Hospital, Beni-Suef, Egypt']","['percutaneous nephrostomy', 'percutaneous nephrostomy group and ureteroscopic laser lithotripsy', 'Percutaneous nephrolithotomy', 'Percutaneous nephrostomy versus JJ ureteric stent', 'shockwave lithotripsy', 'percutaneous nephrolithotomy', 'percutaneous nephrostomy tube group', 'ureteroscopy or shockwave lithotripsy', 'JJ stent', 'percutaneous nephrostomy tube versus JJ stent', 'Definitive stone management']","['serum creatinine normalization, failure of insertion, operative and fluoroscopy time', 'Procedural failure, pelvic perforations and intraoperative bleeding', 'shorter operative time', 'Procedural failure, ureteric mucosal injury and perforations increased in the case of male sex, stone size >1.5\xa0cm and upper ureteric stones', 'Suprapubic pain, urethral pain and lower urinary tract symptoms', 'recovery period for normalization of serum creatinine']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0034216', 'cui_str': 'Pyonephrosis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0027724', 'cui_str': 'Percutaneous insertion of nephrostomy tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4728074', 'cui_str': 'Procedural failure'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0241310', 'cui_str': 'Suprapubic pain'}, {'cui': 'C0151830', 'cui_str': 'Pain in urethra'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]",143.0,0.0326312,"Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elbatanouny', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Ragheb', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelbary', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Fathy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Massoud', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abd El Latif', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Ayman S', 'Initials': 'AS', 'LastName': 'Moussa', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Rabie M', 'Initials': 'RM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14331']
1756,32853783,Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: A randomized controlled trial.,"BACKROUND


To investigate the effect of postoperative coffee consumption on bowel motility after laparoscopic gynecological surgery.
MATERIALS AND METHODS


In this randomized controlled trial, patients were allocated postoperatively to 3 cups of either coffee or warm water at 6, 12, or 18 h after the operation. Total hysterectomy and bilateral salpingectomy were performed on all patients. In addition, a salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy were performed according to clinical indications. The primary endpoint was time to the first passage of flatus after surgery.
RESULTS


A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water). The median time to flatus (19 [13-35] vs. 25 [15-42] h; hazard ratio [HR] 1.9, 95% confidence interval [CI], 1.2-2.9; P = 0.0009), median time to defecation (30 [22-54] vs. 38 [26-65] h, HR 2.4, 95% CI, 1.5-3.8; P < 0.0001), and mean time to tolerate food (2 [2-5] vs. 3 [2-8] days, HR 1.5, 95% CI, 1.02-2.3; P = 0.002) were decreased significantly in patients who consumed coffee compared with the control subjects. Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02). No adverse events were attributed to coffee consumption.
CONCLUSION


Postoperative coffee intake after laparoscopic gynecological surgery hastened the recovery of gastrointestinal function by reducing the time to the first passage of flatus, time to the first defecation, and time to tolerate a solid diet. This simple, cheap, and well-tolerated treatment merits routine use alongside other existing enhanced recovery pathways in the postoperative setting.",2020,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"['A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water', 'after laparoscopic gynecological surgery']","['salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy', 'Coffee consumption', 'postoperative coffee consumption']","['mean time to tolerate food', 'intestinal function', 'Total hysterectomy and bilateral salpingectomy', 'adverse events', 'bowel motility', 'time to the first passage of flatus after surgery', 'Postoperative ileus', 'recovery of gastrointestinal function', 'median time to flatus', 'median time to defecation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195509', 'cui_str': 'Bilateral complete salpingectomy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",96.0,0.115899,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey. Electronic address: drkemalgungorduk@gmail.com.'}, {'ForeName': 'Ezgi Karakas', 'Initials': 'EK', 'LastName': 'Paskal', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Demirayak', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sezen Bozkurt', 'Initials': 'SB', 'LastName': 'Köseoğlu', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Akbaba', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Isa Aykut', 'Initials': 'IA', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.016']
1757,32854772,Rivaroxaban compared to no treatment in ER-negative stage I-III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial.,"BACKGROUND


Breast cancer patients are at a four-fold increased risk of developing a venous thromboembolism (VTE), a major cause of death in this group. Conversely, coagulation factors promote tumour growth and metastasis. This has been evidenced in preclinical models, with an inhibitory effect of anticoagulants on cancer growth through proliferative, angiogenic, apoptotic, cancer stem cell and metastatic processes. The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin. Rivaroxaban (Xarelto®, Bayer AG, Leverkusen, Germany) is a direct oral anticoagulant (DOAC). It is a Factor Xa inhibitor that is routinely prescribed for the prevention of stroke in non-valvular atrial fibrillation and for both VTE prophylaxis and treatment. This trial will assess the anti-proliferative and other anti-cancer progression mechanisms of Rivaroxaban in ER-negative early breast cancer patients.
METHODS


This UK-based preoperative window-of-opportunity phase II randomised control trial will randomise 88 treatment-naïve early breast cancer patients to receive 20 mg OD Rivaroxaban treatment for 11 to 17 days or no treatment. Treatment will be stopped 24 h (range 18-36 h) prior to surgery or repeat core biopsy. All patients will be followed up for 2 weeks following surgery or repeat core biopsy. The primary endpoint is change in tumour Ki67. Secondary outcome measures include tumour markers of apoptosis and angiogenesis, extrinsic clotting pathway activation and systemic markers of metastasis, tumour load and coagulation.
DISCUSSION


Laboratory evidence supports an anti-cancer role for anticoagulants; however, this has failed to translate into survival benefit when trialled in patients with metastatic disease or poor prognosis cancers, such as lung cancer. Subgroup analysis supported a potential survival benefit in better prognosis advanced disease patients. This is the first study to investigate the anti-cancer effects of anticoagulants in early breast cancer.
TRIAL REGISTRATION


UK National Research Ethics Service (NRES) approval 15/NW/0406, MHRA Clinical Trials Authorisation 48380/0003/001-0001. The sponsor is Manchester University NHS Foundation Trust, and the trial is co-ordinated by Cancer Research UK Liverpool Cancer Trials Unit (LCTU). EudraCT 2014-004909-33 , registered 27 July 2015. ISRCTN14785273 .",2020,"The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin.","['prognosis advanced disease patients', 'ER-negative early breast cancer patients', 'Breast cancer patients', '88 treatment-naïve early breast cancer patients', 'patients with metastatic disease or poor prognosis cancers', 'ER-negative stage I-III early breast cancer patients']","['20\u2009mg OD Rivaroxaban', 'Rivaroxaban', 'Rivaroxaban (Xarelto®, Bayer AG, Leverkusen, Germany']","['tumour markers of apoptosis and angiogenesis, extrinsic clotting pathway activation and systemic markers of metastasis, tumour load and coagulation', 'potential survival benefit', 'change in tumour Ki67']","[{'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3159309', 'cui_str': 'Xarelto'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C1869090', 'cui_str': 'Tumour markers (SMQ)'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.108316,"The extrinsic clotting pathway is also more upregulated in patients in the relatively poorer prognosis oestrogen receptor (ER)-negative breast cancer subgroup, with increased tumour stromal expression of the coagulation factors Tissue Factor and thrombin.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Castle', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Blower', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Bundred', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'The Nightingale Centre, Wythenshawe Hospital, Manchester, M23 9LT, UK.'}, {'ForeName': 'Jecko', 'Initials': 'J', 'LastName': 'Thachil', 'Affiliation': 'Department of Haematology, Manchester Royal Infirmary, Manchester, M13 9WL, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Department of Breast Surgery, Maidstone Hospital, Maidstone, ME16 9QQ, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cicconi', 'Affiliation': 'Cancer Research UK Liverpool Cancer Trials Unit, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Breast Unit, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, L3 9TA, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Palmieri', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Wilmslow Road, Manchester, M20 4GJ, UK. cliona.kirwan@manchester.ac.uk.'}]",Trials,['10.1186/s13063-020-04675-7']
1758,32858033,A Randomized Placebo-Controlled Pilot Trial of Early Targeted Nonsteroidal Anti-Inflammatory Drugs in Preterm Infants with a Patent Ductus Arteriosus.,"OBJECTIVE


To establish the feasibility of a future large randomized trial to compare early treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) while awaiting spontaneous patent ductus arteriosus (PDA) closure.
STUDY DESIGN


Preterm infants at <29 weeks of gestation with a PDA diameter >1.5 mm and <72 hours after birth were randomized to NSAIDs vs placebo. No open-label NSAID treatment was allowed in either arm, but all infants with PDA volume load received supportive management, including optimization of airway pressure, careful fluid management, and diuretics as needed. The pilot outcomes were recruitment rate and incidence of open-label treatment. Secondary clinical outcomes included chronic lung disease or death, the planned primary outcome for a future large trial.
RESULTS


Overall, 54% of the approached parents consented to participate in the study. The median recruitment rate was 3 infants per month, and a total of 72 infants were randomized. One patient in each arm received open-label treatment. PDA closure rates were 74% for the NSAIDs arm vs 30% for the placebo arm, but this was not associated with significant changes in clinical outcomes.
CONCLUSIONS


This pilot trial showed that recruitment of more than one-half of eligible infants with a low incidence of open-label treatment is feasible. PDA closure rates and clinical outcomes were similar to those reported in previous PDA trials.",2020,"PDA closure rates were 74% (NSAID) versus 30% (placebo) but this did not lead to significant changes in clinical outcomes.
","['Preterm infants <29 weeks gestation with a PDA diameter >1.5 mm and <72 hours after birth', 'Preterm Infants with a Patent Ductus Arteriosus']","['NSAID versus placebo', 'open label treatment', 'Steroidal Anti-Inflammatory Drugs', 'Placebo', 'non-steroidal anti-inflammatory drugs (NSAIDs']","['PDA closure rates and clinical outcomes', 'median recruitment rate', 'PDA closure rates', 'rate and incidence of open label treatment', 'chronic lung disease or death']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.22599,"PDA closure rates were 74% (NSAID) versus 30% (placebo) but this did not lead to significant changes in clinical outcomes.
","[{'ForeName': 'Koert', 'Initials': 'K', 'LastName': 'de Waal', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, Newcastle, NSW, Australia. Electronic address: koert.dewaal@health.nsw.gov.au.""}, {'ForeName': 'Nilkant', 'Initials': 'N', 'LastName': 'Phad', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, Newcastle, NSW, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stubbs', 'Affiliation': ""Department of Neonatology, John Hunter Children's Hospital and University of Newcastle, Newcastle, NSW, Australia.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.062']
1759,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
1760,32861273,"Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


BRCA1 or BRCA2-mutated breast cancers are sensitive to poly(ADP-ribose) polymerase (PARP) inhibitors and platinum agents owing to deficiency in homologous recombination repair of DNA damage. In this trial, we compared veliparib versus placebo in combination with carboplatin and paclitaxel, and continued as monotherapy if carboplatin and paclitaxel were discontinued before progression, in patients with HER2-negative advanced breast cancer and a germline BRCA1 or BRCA2 mutation.
METHODS


BROCADE3 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 147 hospitals in 36 countries. Eligible patients (aged ≥18 years) had deleterious germline BRCA1 or BRCA2 mutation-associated, histologically or cytologically confirmed advanced HER2-negative breast cancer, an Eastern Cooperative Oncology Group performance status of 0-2, and had received up to two previous lines of chemotherapy for metastatic disease. Patients were randomly assigned (2:1) by interactive response technology by means of permuted blocks within strata (block size of 3 or 6) to carboplatin (area under the concentration curve 6 mg/mL per min intravenously) on day 1 and paclitaxel (80 mg/m 2  intravenously) on days 1, 8, and 15 of 21-day cycles combined with either veliparib (120 mg orally twice daily, on days -2 to 5) or matching placebo. If patients discontinued carboplatin and paclitaxel before progression, they could continue veliparib or placebo at an intensified dose (300 mg twice daily continuously, escalating to 400 mg twice daily if tolerated) until disease progression. Patients in the control group could receive open-label veliparib monotherapy after disease progression. Randomisation was stratified by previous platinum use, history of CNS metastases, and oestrogen and progesterone receptor status. The primary endpoint was investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1. Efficacy analyses were done by intention to treat, which included all randomly assigned patients with a centrally confirmed BRCA mutation, and safety analyses included all patients who received at least one dose of velilparib or placebo. This study is ongoing and is registered with ClinicalTrials.gov, NCT02163694.
FINDINGS


Between July 30, 2014, and Jan 17, 2018, 2202 patients were screened, of whom 513 eligible patients were enrolled and randomly assigned. In the intention-to-treat population (n=509), 337 patients were assigned to receive veliparib plus carboplatin-paclitaxel (veliparib group) and 172 were assigned to receive placebo plus carboplatin-paclitaxel (control group). Median follow-up at data cutoff (April 5, 2019) was 35·7 months (IQR 24·9-43·6) in the veliparib group and 35·5 months (23·1-45·9) in the control group. Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71 [95% CI 0·57-0·88], p=0·0016). The most common grade 3 or worse adverse events were neutropenia (272 [81%] of 336 patients in the veliparib group vs 143 [84%] of 171 patients in the control group), anaemia (142 [42%] vs 68 [40%]), and thrombocytopenia (134 [40%] vs 48 [28%]). Serious adverse events occurred in 115 (34%) patients in the veliparib group versus 49 (29%) patients in the control group. There were no study drug-related deaths.
INTERPRETATION


The addition of veliparib to a highly active platinum doublet, with continuation as monotherapy if the doublet were discontinued, resulted in significant and durable improvement in progression-free survival in patients with germline BRCA mutation-associated advanced breast cancer. These data indicate the utility of combining platinum and PARP inhibitors in this patient population.
FUNDING


AbbVie.",2020,Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71,"['147 hospitals in 36 countries', 'BRCA-mutated advanced breast cancer (BROCADE3', 'Between July 30, 2014, and Jan 17, 2018, 2202 patients were screened, of whom 513 eligible patients were enrolled and randomly assigned', '337 patients', 'Eligible patients (aged ≥18 years) had deleterious germline BRCA1 or BRCA2 mutation-associated, histologically or cytologically confirmed advanced HER2-negative breast cancer, an Eastern Cooperative Oncology Group performance status of 0-2, and had received up to two previous lines of chemotherapy for metastatic disease', 'patients with HER2-negative advanced breast cancer and a germline BRCA1 or BRCA2 mutation', 'patients with germline BRCA mutation-associated advanced breast cancer']","['carboplatin and paclitaxel', 'Veliparib with carboplatin and paclitaxel', 'open-label veliparib monotherapy', 'veliparib versus placebo', 'placebo', 'velilparib or placebo', 'veliparib plus carboplatin-paclitaxel (veliparib group', 'veliparib', 'placebo plus carboplatin-paclitaxel (control group', 'platinum and PARP inhibitors', 'interactive response technology by means of permuted blocks within strata (block size of 3 or 6) to carboplatin (area under the concentration curve 6 mg/mL per min intravenously) on day 1 and paclitaxel']","['thrombocytopenia', 'Serious adverse events', 'neutropenia', 'anaemia', 'progression-free survival', 'investigator-assessed progression-free survival per Response Evaluation Criteria', 'Median progression-free survival']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",2202.0,0.566861,Median progression-free survival was 14·5 months (95% CI 12·5-17·7) in the veliparib group versus 12·6 months (10·6-14·4) in the control group (hazard ratio 0·71,"[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Institut Curie, Paris, France; Breast Oncology, Centre Eugène Marquis, Rennes, France. Electronic address: v.dieras@rennes.unicancer.fr.'}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Tel-Aviv University, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Prince of Wales Clinical School UNSW and Prince of Wales Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Ayoub', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Puhalla', 'Affiliation': 'UPMC Cancer Centers, Pittsburgh, PA, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, City Clinical Hospital Number 4, Dnipro, Ukraine.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest Saint-Herblain, France.""}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Jalving', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Oprean', 'Affiliation': 'University of Medicine and Pharmacy Timisoara and Oncomed SRL, Timisoara, Romania.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Palácová', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yaroslav', 'Initials': 'Y', 'LastName': 'Shparyk', 'Affiliation': 'Lviv State Regional Treatment and Diagnostic Oncology Center, Lviv, Ukraine.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Yañez', 'Affiliation': 'Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Khandelwal', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Madan G', 'Initials': 'MG', 'LastName': 'Kundu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dudley', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Ratajczak', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Banu K', 'Initials': 'BK', 'LastName': 'Arun', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30447-2']
1761,32861306,Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial.,"BACKGROUND


Traditional and faith healers (TFH) provide care to a large number of people with psychosis in many sub-Saharan African countries but they practise outside the formal mental health system. We aimed to assess the effectiveness and cost-effectiveness of a collaborative shared care model for psychosis delivered by TFH and primary health-care providers (PHCW).
METHODS


In this cluster-randomised trial in Kumasi, Ghana and Ibadan, Nigeria, we randomly allocated clusters (a primary care clinic and neighbouring TFH facilities) 1:1, stratified by size and country, to an intervention group or enhanced care as usual. The intervention included a manualised collaborative shared care delivered by trained TFH and PHCW. Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60). The primary outcome, by masked assessments at 6 months, was the difference in psychotic symptom improvement as measured with the PANSS in patients in follow-up at 3 and 6 months. Patients exposure to harmful treatment practices, such as shackling, were also assessed at 3 and 6 months. Care costs were assessed at baseline, 3-month and 6-month follow-up, and for the entire 6 months of follow-up. This trial was registered with the National Institutes of Health Clinical Trial registry, NCT02895269.
FINDINGS


Between Sept 1, 2016, and May 3, 2017, 51 clusters were randomly allocated (26 intervention, 25 control) with 307 patients enrolled (166 [54%] in the intervention group and 141 [46%] in the control group). 190 (62%) of participants were men. Baseline mean PANSS score was 107·3 (SD 17·5) for the intervention group and 108·9 (18·3) for the control group. 286 (93%) completed the 6-month follow-up at which the mean total PANSS score for intervention group was 53·4 (19·9) compared with 67·6 (23·3) for the control group (adjusted mean difference -15·01 (95% CI -21·17 to -8·84; 0·0001). Harmful practices decreased from 94 (57%) of 166 patients at baseline to 13 (9%) of 152 at 6 months in the intervention group (-0·48 [-0·60 to -0·37] p<0·001) and from 59 (42%) of 141 patients to 13 (10%) of 134 in the control group (-0·33 [-0·45 to -0·21] p<0·001), with no significant difference between the two groups. Greater reductions in overall care costs were seen in the intervention group than in the control group. At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group). Five patients in the intervention group had mild extrapyramidal side effects.
INTERPRETATION


A collaborative shared care delivered by TFH and conventional health-care providers for people with psychosis was effective and cost-effective. The model of care offers the prospect of scaling up improved care to this vulnerable population in settings with low resources.
FUNDING


US National Institute of Mental Health.",2020,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","['Nigeria and Ghana (COSIMPO', '190 (62%) of participants were men', 'Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60']","['Traditional and faith healers (TFH) provide care', 'intervention group or enhanced care as usual', 'collaborative care between traditional and faith healers and primary health-care workers', 'collaborative shared care model', 'manualised collaborative shared care delivered by trained TFH and PHCW']","['total health service and time costs', 'psychotic symptom improvement', 'Care costs', 'Harmful practices', 'effectiveness and cost-effectiveness', 'mean total PANSS score', 'cumulative costs', 'mild extrapyramidal side effects', 'overall care costs', 'Baseline mean PANSS score']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",307.0,0.145641,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","[{'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. Electronic address: ogureje@com.ui.edu.ng.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Appiah-Poku', 'Affiliation': 'Department of Behavioural Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Bello', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Oluyomi', 'Initials': 'O', 'LastName': 'Esan', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Department of Psychiatry, University of Liberia, Monrovia, Liberia.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Makanjuola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Othieno', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'LeShawndra', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Department of Health and Human Services, National Institute of Mental Health, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD, USA.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Stellenbosch University, Cape Town, South Africa.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30634-6']
1762,32862007,Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study.,"BACKGROUND


Activation of the oxytocin network has shown benefits in animal models of Obstructive Sleep Apnea (OSA) as well as other cardiorespiratory diseases. We sought to determine if nocturnal intranasal oxytocin administration could have beneficial effects in reducing the duration and/or frequency of obstructive events in obstructive sleep apnea subjects.
METHODS


Two sequential standard ""in-lab"" polysomnogram (PSG) sleep studies were performed in patients diagnosed with OSA that were randomly assigned to initially receive either placebo or oxytocin (40 i.u.) administered intranasally in this double blinded randomized placebo controlled study. Changes in cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate were assessed in 2 h epochs following sleep onset. Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events. Notably, oxytocin increased respiratory rate during non-obstructive periods. There were no significant changes in sleep architecture and no adverse effects were reported.
CONCLUSIONS


Oxytocin administration can benefit OSA subjects by reducing the duration and adverse consequences of obstructive events. Oxytocin could also be beneficial in situations involving respiratory depression as oxytocin increased respiratory rate. Additional studies are needed to further understand the mechanisms by which oxytocin promotes these changes in cardiorespiratory function. The long-term efficacy and optimal dose of intranasal oxytocin treatment should also be determined in OSA subjects. ClinicalTrials.gov NCT03148899.",2020,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","['obstructive sleep apnea subjects', 'Two sequential standard ""in-lab"" polysomnogram (PSG', 'obstructive sleep apnea patients', 'patients diagnosed with OSA', 'OSA subjects']","['oxytocin network', 'intranasal oxytocin', 'oxytocin', 'nocturnal intranasal oxytocin', 'placebo', 'Oxytocin', 'placebo or oxytocin', 'Intranasal oxytocin']","['duration of obstructive events', 'respiratory rate', 'cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate', 'respiratory rate and reduces obstructive event duration and oxygen desaturation', 'oxygen desaturations and incidence of bradycardia', 'sleep architecture and no adverse effects']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0853204', 'cui_str': 'No adverse effect'}]",,0.200305,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kimbro', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Kowalik', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Milojevic', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Maritza Dowling', 'Affiliation': 'Department of Acute & Chronic Care, School of Nursing, Department of Epidemiology & Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Anne Lloyd', 'Initials': 'AL', 'LastName': 'Hunley', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hauser', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Andrade', 'Affiliation': 'Centro de Fisiología Del Ejercicio, Universidad Mayor, Santiago, Chile; Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Del Rio', 'Affiliation': 'Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile; Center for Aging and Regeneration (CARE-UC), Pontificia Universidad Católica de Chile, Santiago, Chile; Centro de Excelencia de Biomedicina en Magallanes (CEBIMA), Universidad de Magallanes, Punta Arenas, Chile.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kay', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mendelowitz', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA. Electronic address: dmendel@gwu.edu.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.034']
1763,32862009,Altered cortical gray matter volume and functional connectivity after transcutaneous spinal cord direct current stimulation in idiopathic restless legs syndrome.,"OBJECTIVE


To explore the neurophysiological mechanism of clinically effective transcutaneous spinal cord direct current stimulation (tsDCS) on idiopathic restless legs syndrome (RLS), structural magnetic resonance imaging (sMRI), and resting-state functional MRI (rs-fMRI) were applied to reveal the structural and functional changes in idiopathic RLS patients after tsDCS.
METHODS


Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled. All patients were randomly divided into anodal treatment group and sham treatment group and were treated with tsDCS for 2 weeks. The international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the severity of RLS and sleep quality respectively. The sMRI and rs-fMRI data of anodal treatment group and HC were collected. Voxel-based morphology (VBM) and resting-state functional connectivity analysis were used to assess the change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC) respectively in anodal treatment group after tsDCS treatment.
RESULTS


Sham treatment group showed no significant change in IRLS-RS and PSQI scores after tsDCS, while significant decrease scores were observed in anodal treatment group, and the improvement sustained up to 2 weeks. Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC. After tsDCS treatment, the GMV in the bilateral cuneus and left ventral post central gyrus (PoCG_L) decreased significantly. The FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R) increased significantly after tsDCS, whereas the FC between PoCG_L and supplementary motor area (SMA) decreased significantly. The changed FC between PoCG_L and SMA, between Cune_R and V1_L were correlated with the changed IRLS-RS.
CONCLUSION


Disturbance of sensorimotor network and visual processing network may be involved in the pathogenesis of RLS. tsDCS probably can regulate FC in the sensorimotor cortex and visual processing cortex to relieve the symptom of RLS. Continuous tsDCS may improve the symptoms of RLS patients for a long time. tsDCS probably could provide a potential non-pharmacologic treatment for idiopathic RLS patients.",2020,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"['idiopathic restless legs syndrome (RLS', 'idiopathic RLS patients after tsDCS', 'idiopathic restless legs syndrome', 'idiopathic RLS patients', 'Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled']","['transcutaneous spinal cord direct current stimulation (tsDCS', 'transcutaneous spinal cord direct current stimulation', 'anodal treatment group and sham treatment group and were treated with tsDCS', 'tsDCS']","['change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC', 'international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI', 'bilateral cuneus and left ventral post central gyrus (PoCG_L', 'FC between PoCG_L and supplementary motor area (SMA', 'IRLS-RS and PSQI scores', 'regional decrease of GMV in bilateral cuneus', 'FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038446', 'cui_str': 'Area striata structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}]",30.0,0.0317877,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Jiaojian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: jiaojianwang@uestc.edu.com.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China. Electronic address: wangyuping01@sina.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.026']
1764,32863126,Anthropometric changes in the morphology of the lower eyelid after using three different approaches in patients with orbital fractures.,"PURPOSE


The aim of this prospective study was to address the anthropometric changes in the morphology of the lower eyelid and esthetic outcomes after performing subciliary, subtarsal, and transconjunctival approaches in patients with orbital and periorbital fractures.
PATIENTS AND METHODS


A prospective randomized controlled clinical study was undertaken on patients with orbital floor and infraorbital rim fractures. These were equally divided into three groups: in group 1, the fractures were approached via a stepped subciliary approach; in group 2, they were approached via a subtarsal approach; in group 3, a retroseptal transconjunctival approach was performed. The patients were assessed for anthropometric changes in the morphology of the lower eyelid, esthetic outcomes, and postoperative lower eyelid complications (LLCs). A one-way ANOVA test was used to analyze differences between the operated and non-operated sides and the effect of the surgical approach on anthropometric measurements.
RESULTS


A total of 45 patients were included in the study. All the surgical approaches provided adequate surgical exposure of the infraorbital rim and orbital floor. The subtarsal approach allowed rapid access to the field (10.5 ± 1.9 min). All incisions resulted in adequate postoperative esthetic outcomes. Anthropometric analysis revealed that there were no significant differences between the three approaches, except for measurements of the eye fissure index (EFI) and lower iris coverage (LIC). Mean EFI measurements increased on all operated sides. The subciliary approach showed the highest percentage of increased measurements of this variable (34.5 ± 4.6), followed by the subtarsal approach (32 ± 2.1), and then the transconjunctival approach (31.1 ± 3.7), with p = 0.046. Furthermore, the subciliary approach significantly decreased the measurements of LIC. This change was also bigger with the subciliary approach (1.09 ± 2.3) than with the subtarsal approach (2.1 ± 2.4) or transconjunctival approach (3.4 ± 2.6), with p = 0.048.
CONCLUSION


Based on the results of this study, the subtarsal approach is a minimally invasive incision that provides an adequate and direct approach to orbital floor and infraorbital rim fractures, with a favorable periorbital architecture and the lowest incidence of LLCs. Therefore, the subtarsal technique should be preferred over subciliary and transconjunctival approaches.",2020,"Anthropometric analysis revealed that there were no significant differences between the three approaches, except for measurements of the eye fissure index (EFI) and lower iris coverage (LIC).","['A total of 45 patients were included in the study', 'patients with orbital fractures', 'patients with orbital and periorbital fractures', 'patients with orbital floor and infraorbital rim fractures']",['retroseptal transconjunctival approach'],"['eye fissure index (EFI) and lower iris coverage (LIC', 'measurements of LIC', 'adequate postoperative esthetic outcomes', 'postoperative lower eyelid complications (LLCs', 'Mean EFI measurements']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029184', 'cui_str': 'Fracture of orbit'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0230060', 'cui_str': 'Structure of inferior wall of orbit'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0442347', 'cui_str': 'Transconjunctival approach'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",45.0,0.0246682,"Anthropometric analysis revealed that there were no significant differences between the three approaches, except for measurements of the eye fissure index (EFI) and lower iris coverage (LIC).","[{'ForeName': 'Fatma Ibrahim', 'Initials': 'FI', 'LastName': 'Mohamed', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dental Medicine for Girls, Al Azhar University, P.O. Box 11727, Nasr City, Cairo, Egypt. Electronic address: fatma_ibrahim36@yahoo.com.'}, {'ForeName': 'Hanan Mohamed', 'Initials': 'HM', 'LastName': 'Reda', 'Affiliation': 'Oral and Maxillofacial Surgery, Faculty of Dental Medicine for Girls, Al Azhar University, P.O. Box 11727, Nasr City, Cairo, Egypt. Electronic address: Hanan_mezo47@yahoo.com.'}, {'ForeName': 'Ghada Amin', 'Initials': 'GA', 'LastName': 'Khalifa', 'Affiliation': 'Professor of Oral and Maxillofacial Surgery, College of Dentistry, Qassim University, 1162, Qassim Region, Al-Mulida, North of Prince Nayef bin Abdulaziz International Airport, Kingdom of Saudi Arabia. Electronic address: ghadaamin@ymail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.08.002']
1765,32866432,"Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).
METHODS


In this multicentre, open-label, phase 3, randomised controlled trial (the ENDURANCE trial; E1A11), we recruited patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT. Participants were recruited from 272 community oncology practices or academic medical centres in the USA. Key inclusion criteria were the absence of high-risk multiple myeloma and an Eastern Cooperative Oncology Group performance status of 0-2. Enrolled patients were randomly assigned (1:1) centrally by use of permuted blocks to receive induction therapy with either the VRd regimen or the KRd regimen for 36 weeks. Patients who completed induction therapy were then randomly assigned (1:1) a second time to either indefinite maintenance or 2 years of maintenance with lenalidomide. Randomisation was stratified by intent for ASCT at disease progression for the first randomisation and by the induction therapy received for the second randomisation. Allocation was not masked to investigators or patients. For 12 cycles of 3 weeks, patients in the VRd group received 1·3 mg/m 2  of bortezomib subcutaneously or intravenously on days 1, 4, 8, and 11 of cycles 1-8, and day 1 and day 8 of cycles nine to twelve, 25 mg of oral lenalidomide on days 1-14, and 20 mg of oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. For nine cycles of 4 weeks, patients in the KRd group received 36 mg/m 2  of intravenous carfilzomib on days 1, 2, 8, 9, 15, and 16, 25 mg of oral lenalidomide on days 1-21, and 40 mg of oral dexamethasone on days 1, 8, 15, and 22. The coprimary endpoints were progression-free survival in the induction phase, and overall survival in the maintenance phase. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of their assigned treatment. The trial is registered with ClinicalTrials.gov, NCT01863550. Study recruitment is complete, and follow-up of the maintenance phase is ongoing.
FINDINGS


Between Dec 6, 2013, and Feb 6, 2019, 1087 patients were enrolled and randomly assigned to either the VRd regimen (n=542) or the KRd regimen (n=545). At a median follow-up of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival was 34·6 months (95% CI 28·8-37·8) in the KRd group and 34·4 months (30·1-not estimable) in the VRd group (hazard ratio [HR] 1·04, 95% CI 0·83-1·31; p=0·74). Median overall survival has not been reached in either group. The most common grade 3-4 treatment-related non-haematological adverse events included fatigue (34 [6%] of 527 patients in the VRd group vs 29 [6%] of 526 in the KRd group), hyperglycaemia (23 [4%] vs 34 [6%]), diarrhoea (23 [5%] vs 16 [3%]), peripheral neuropathy (44 [8%] vs four [<1%]), dyspnoea (nine [2%] vs 38 [7%]), and thromboembolic events (11 [2%] vs 26 [5%]). Treatment-related deaths occurred in two patients (<1%) in the VRd group (one cardiotoxicity and one secondary cancer) and 11 (2%) in the KRd group (four cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death).
INTERPRETATION


The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity. The VRd triplet regimen remains the standard of care for induction therapy for patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma, and is a suitable treatment backbone for the development of combinations of four drugs.
FUNDING


US National Institutes of Health, National Cancer Institute, and Amgen.",2020,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","['Patients who completed induction therapy', '1087 patients', 'Participants were recruited from 272 community oncology practices or academic medical centres in the USA', 'patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE', 'patients with standard-risk and intermediate-risk newly diagnosed multiple myeloma', 'newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT', 'newly diagnosed multiple myeloma', 'patients aged 18 years or older with newly diagnosed multiple myeloma who were ineligible for, or did not intend to have, immediate ASCT']","['lenalidomide and dexamethasone', 'KRd', 'lenalidomide and dexamethasone (KRd', 'bortezomib', 'oral dexamethasone', 'indefinite maintenance or 2 years of maintenance with lenalidomide', 'VRd regimen', 'KRd regimen', 'intravenous carfilzomib', 'Carfilzomib or bortezomib', 'induction therapy with either the VRd regimen or the KRd regimen', 'oral lenalidomide', 'Bortezomib, lenalidomide, and dexamethasone (VRd']","['thromboembolic events', 'cardiotoxicity, two acute kidney failure, one liver toxicity, two respiratory failure, one thromboembolic event, and one sudden death', 'diarrhoea', 'intention-to-treat population and safety', 'deaths', 'progression-free survival in the induction phase, and overall survival', 'progression-free survival', 'toxicity', 'dyspnoea', 'median progression-free survival', 'Median overall survival', 'peripheral neuropathy', 'hyperglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",1087.0,0.211992,"The KRd regimen did not improve progression-free survival compared with the VRd regimen in patients with newly diagnosed multiple myeloma, and had more toxicity.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Jacobus', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Cohen', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'ThedaCare, Appleton, WI, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Avina K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'MOHPA, Burnsville, MN, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Parker', 'Affiliation': 'Department of Hematology, Yale University, Hamden, CT, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Kaiser Permanente Lone Tree, Lone Tree, CO, USA.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Saint Francis Cancer Center, Greenville, NC, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Parsons', 'Affiliation': 'Gundersen Health System, La Crosse, WI, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Illinois Cancer Care, Peoria, IL, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Rosenberg', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Zonder', 'Affiliation': 'Department of Malignant Hematology, Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Faber', 'Affiliation': 'Oncology Hematology Care, Cincinnati, OH, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30452-6']
1766,32866440,"Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis.
METHODS


In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10-35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual.
FINDINGS


Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was -6·14 for tocilizumab and -4·41 for placebo (adjusted difference -1·73 [95% CI -3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0-6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37-1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo. In the safety set, infections were the most common adverse events (54 [52%] of 104 participants in the tocilizumab group, 53 [50%] of 106 in the placebo group). Serious adverse events were reported in 13 participants treated with tocilizumab and 18 with placebo, primarily infections (three events, eight events) and cardiac events (two events, seven events).
INTERPRETATION


The primary skin fibrosis endpoint was not met. Findings for the secondary endpoint of FVC% predicted indicate that tocilizumab might preserve lung function in people with early SSc-ILD and elevated acute-phase reactants. Safety was consistent with the known profile of tocilizumab.
FUNDING


F Hoffmann-La Roche Ltd.",2020,Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo.,"['Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10-35 at screening', 'systemic sclerosis', 'participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan', 'Between Nov 20, 2015, and Feb 14, 2017, 210 individuals']","['voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo', '1·73', 'tocilizumab and placebo', 'Tocilizumab', 'placebo', 'tocilizumab']","['Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments', 'Serious adverse events', 'cardiac events', 'lung function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",210.0,0.760913,Change in LSM from baseline to week 48 in Health Assessment Questionnaire-Disability Index and in patient-global and physician-global visual analogue scale assessments did not differ between tocilizumab and placebo.,"[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA. Electronic address: khannad@med.umich.edu.'}, {'ForeName': 'Celia J F', 'Initials': 'CJF', 'LastName': 'Lin', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Shima', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'van Laar', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Spotswood', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Jahreis', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30318-0']
1767,32870466,The Effects of Mobile-App-Based Low-Carbohydrate Dietary Guidance on Postprandial Hyperglycemia in Adults with Prediabetes.,"INTRODUCTION


Postprandial hyperglycemia is independently associated with many adverse complications, while diets with a low glycemic load are beneficial in improving post-meal glucose levels. This study aims to determine if mobile-app-based low-carbohydrate dietary guidance will reduce exposure to postprandial hyperglycemia in adults with prediabetes.
METHODS


This single-blind, randomized controlled pilot study included 100 participants (39 men; mean age 53.6 ± 11.9 years) and was performed in the PKU Care CNOOC Hospital, China. The intervention group (n = 57) received low-carbohydrate dietary guidance through a moblie app (CAReNA) for 3 months, while the control group (n = 43) only received health education on a diabetic diet. The primary outcome was change in time of postprandial hyperglycemia between baseline and 3 months.
RESULTS


The study revealed that the mean time in postprandial hyperglycemia (> 7.8 mmol/l [140 mg/dl]) monitored by flash glucose monitoring changed from 3.27 h/day at baseline to 2.34 h/day at 3 months in the intervention group and from 3.08 h/day to 2.96 h/day in the control group, with a between-group difference of - 0.81 h/day (P < 0.05). Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups. Compared with the control group, the intervention group had a significant decrease in anthropometric and body composition measurements as well as triglycerides.
CONCLUSION


The mobile-app-based low-carbohydrate dietary guidance effectively reduced the time spent in postprandial hyperglycemia in adults with prediabetes. This new type of nutritional management has beneficial effects on people with prediabetes and needs further research.
CLINICAL TRIAL REGISTRATION


ChiCTR1900024880.",2020,"Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups.","['100 participants (39 men; mean age 53.6\u2009±\u200911.9\xa0years) and was performed in the PKU Care CNOOC Hospital, China', 'Adults with Prediabetes', 'adults with prediabetes']","['low-carbohydrate dietary guidance through a moblie app (CAReNA) for 3 months, while the control group (n\u2009=\u200943) only received health education on a diabetic diet', 'Mobile-App-Based Low-Carbohydrate Dietary Guidance', 'mobile-app-based low-carbohydrate dietary guidance']","['Postprandial Hyperglycemia', 'time spent in postprandial hyperglycemia', 'mean time in postprandial hyperglycemia', 'flash glucose monitoring', 'Fasting plasma glucose and glycated hemoglobin (HbA1c', 'triglycerides', 'anthropometric and body composition measurements', 'change in time of postprandial hyperglycemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",100.0,0.0620552,"Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, TEDA International Cardiovascular Hospital, Cardiovascular Clinical College of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kunii', 'Affiliation': 'Department of Food and Nutritional Sciences, Jumonji University, Tokyo, Japan.'}, {'ForeName': 'Kousuke', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Japan Nutrition Care Service Association, Tokyo, Japan.'}, {'ForeName': 'Yiyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Food and Nutritional Sciences, Jumonji University, Tokyo, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': 'School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital, Shanghai, China. guoqijp@gmail.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00906-x']
1768,32845740,Safety and efficacy of galcanezumab in Taiwanese patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine.,"OBJECTIVE


Migraine is a chronic, disabling neurological disease affecting >1 billion people worldwide. Migraine remains undertreated in Asia, including Taiwan. Galcanezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide, a peptide firmly established in the pathophysiology of migraine, with demonstrated efficacy and safety in patients with episodic or chronic migraine. Our objective was to evaluate the efficacy and safety of galcanezumab in Taiwanese patients with episodic or chronic migraine.
METHODS


We conducted a sub-group analysis of the Taiwanese cohort from two double-blind, placebo-controlled, Phase 3 clinical trials of galcanezumab in the prevention of episodic and chronic migraine, EVOLVE-2 (NCT02614196) and REGAIN (NCT02614261), respectively. During the EVOLVE-2 and REGAIN double-blind periods, 2092 patients were randomly assigned to receive monthly injections of either placebo, 120 mg galcanezumab (240 mg loading dose), or 240 mg galcanezumab. In REGAIN, a 9-month open-label period followed. Post-hoc analysis on the Taiwanese population across both trials included 106 patients, 45 of whom continued into the open-label period in REGAIN.
RESULTS


Our findings show that galcanezumab has similar efficacy and safety in the Taiwanese population, as compared to the ""All Patients"" population included in the study. Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with  a  ≥ 50% response, and positively impacted quality of life.
CONCLUSION


Galcanezumab is a promising therapeutic for the preventive treatment of migraine in the Taiwanese population.",2020,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","['Taiwanese Patients', '2092 patients', '106 patients, 45 of whom continued into the open-label period in REGAIN', 'Taiwanese patients with episodic or chronic migraine', 'patients with episodic or chronic migraine', 'Migraine remains undertreated in Asia, including Taiwan']","['galcanezumab', 'placebo', 'Galcanezumab']","['Safety and efficacy', 'efficacy and safety', 'quality of life', 'number of monthly migraine headache days']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2092.0,0.145128,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","[{'ForeName': 'Chun-Pai', 'Initials': 'CP', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Kuang Tien General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chia-Fang', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Eli Lilly and Company, Taipei, Taiwan.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': ""Dell'Agnello"", 'Affiliation': 'Eli Lilly and Company, Sesto Fiorentino, Italy.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hundemer', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Neurological Institute, Taipei-Veterans General Hospital, Taipei, Taiwan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1815181']
1769,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
1770,32856146,A comparison between short- and long-term D-J stent in Anderson-Hynes pyeloplasty for pelvi-ureteric junction obstruction.,"PURPOSE


A double-J (D-J) stent is usually kept in situ during Anderson-Hynes (A-H) pyeloplasty for pelvi-ureteric junction (PUJ) obstruction. The aim of the study is to determine whether early removal of D-J stent is better than long-term stenting.
METHODS


In this prospective comparative study, conducted from January 2018 to April 2019 in Chittagong Medical College Hospital, patients with PUJ obstruction, age less than 12 years, were divided into group A (long-term stenting) and group B (short-term stenting) by simple randomization. Main outcome variables were urinary tract infection (UTI), stent colonization, encrustation, renal cortical thickness, differential renal function (DRF), glomerular filtration rate (GFR), and flow rate in DTPA renogram.
RESULTS


There were 31 patients in each group. Median age was 5 years (IQR: 2.3 to 7 years) and male to female ratio was 2.1:1. Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (p < 0.001). All the patients of both groups had similar improvement in renal cortical thickness, DRF, GFR, and flow rate. The study was potentially limited by its small sample size and high median age (5 years).
CONCLUSION


Early removal of D-J stent had lower incidence of UTI, stent colonization, encrustation, and stent migration.",2020,Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (,"['small sample size and high median age (5\xa0years', 'Median age was 5\xa0years (IQR: 2.3 to 7\xa0years) and male to female ratio was 2.1:1', 'Anderson-Hynes pyeloplasty for pelvi-ureteric junction obstruction', 'conducted from January 2018 to April 2019 in Chittagong Medical College Hospital, patients with PUJ obstruction, age less than 12\xa0years']","['short- and long-term D-J stent', 'double-J (D-J) stent']","['incidence of UTI, stent colonization, encrustation, and stent migration', 'renal cortical thickness, DRF, GFR, and flow rate', 'Frequency of post-operative UTI and stent colonization', 'urinary tract infection (UTI), stent colonization, encrustation, renal cortical thickness, differential renal function (DRF), glomerular filtration rate (GFR), and flow rate in DTPA renogram']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0554139', 'cui_str': 'Pyeloplasty'}, {'cui': 'C0521619', 'cui_str': 'Obstruction of pelviureteric junction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C4087543', 'cui_str': 'Stent migration'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0430198', 'cui_str': 'Differential renal function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013254', 'cui_str': 'Pentetic acid'}]",,0.0356155,Frequency of post-operative UTI and stent colonization were significantly higher in group A than group B (,"[{'ForeName': 'Md Sharif', 'Initials': 'MS', 'LastName': 'Imam', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Abdullah', 'Initials': 'MA', 'LastName': 'Al Farooq', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Khurshid Alam', 'Initials': 'MKA', 'LastName': 'Sarwar', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Tanvir Kabir', 'Initials': 'TK', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh. ivan_tanvir@yahoo.com.'}, {'ForeName': 'Rajib', 'Initials': 'R', 'LastName': 'Khastagir', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Habib', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Walid', 'Affiliation': 'Department of Pediatric Surgery, Chittagong Medical College, 1 KB Fazlul Kader Road, Chittagong, 4203, Bangladesh.'}]",Pediatric surgery international,['10.1007/s00383-020-04734-9']
1771,32856168,Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.,"Item response theory (IRT) was used to characterize the time course of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH-LUTS) measured by item-level International Prostate Symptom Scores (IPSS). The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined. Data from 403 patients with moderate-to-severe BPH-LUTS in a placebo-controlled phase II trial studying the effect of degarelix over 6 months were used for modeling. Three pharmacometric models were developed: a model for total IPSS, a unidimensional IRT model, and a bidimensional IRT model, the latter separating voiding and storage items. The population-level time course of BPH-LUTS in all models was described by initial improvement followed by worsening. In the unidimensional IRT model, the combined information content of IPSS voiding items represented 72% of the total information content, indicating that the voiding subscore may be more sensitive to changes in BPH-LUTS compared with the storage subscore. The pharmacometric models showed considerably higher power to detect a drug effect compared with a cross-sectional and while-on-treatment analysis of covariance, respectively. Compared with the sample size required to detect a drug effect at 80% power with the total IPSS model, a reduction of 5.9% and 11.7% was obtained with the unidimensional and bidimensional IPSS IRT model, respectively. Pharmacometric IRT analysis of the IPSS within BPH-LUTS may increase the precision and efficiency of treatment effect assessment, albeit to a more limited extent compared with applications in other therapeutic areas.",2020,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"['403 patients with moderate-to-severe BPH-LUTS in a', 'Patients with Lower Urinary Tract Symptoms']","['degarelix', 'placebo']",['Item response theory (IRT'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],403.0,0.0227785,The Fisher information content of IPSS items was determined and the power to detect a drug effect using the IRT approach was examined.,"[{'ForeName': 'Yassine Kamal', 'Initials': 'YK', 'LastName': 'Lyauk', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark. yassinekamallyauk@gmail.com.'}, {'ForeName': 'Daniël M', 'Initials': 'DM', 'LastName': 'Jonker', 'Affiliation': 'Translational Medicine, Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Hooker', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}]",The AAPS journal,['10.1208/s12248-020-00500-w']
1772,32856785,"Effects of high-intensity exercise training on physical fitness, quality of life and treatment outcomes after oesophagectomy for cancer of the gastro-oesophageal junction: PRESET pilot study.","BACKGROUND


Treatment for cancer of the gastro-oesophageal junction (GOJ) can result in considerable and persistent impairment of physical fitness and health-related quality of life (HRQoL). This controlled follow-up study investigated the feasibility and safety of postoperative exercise training.
METHODS


Patients with stage I-III GOJ cancer were allocated to 12 weeks of postoperative concurrent aerobic and resistance training (exercise group) or usual care (control group). Changes in cardiorespiratory fitness, muscle strength and HRQoL were evaluated. Adherence to adjuvant chemotherapy, hospitalizations and 1-year overall survival were recorded to assess safety.
RESULTS


Some 49 patients were studied. The exercise group attended a mean of 69 per cent of all prescribed sessions. After exercise, muscle strength and cardiorespiratory fitness were increased and returned to pretreatment levels. At 1-year follow-up, the exercise group had improved HRQoL (+13·5 points, 95 per cent c.i. 2·2 to 24·9), with no change in the control group (+3·7 points, -5·9 to 13·4), but there was no difference between the groups at this time point (+9·8 points, -5·1 to 24·8). Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i. 0·74 to 1·44), relative dose intensity of adjuvant chemotherapy (mean 57 versus 63 per cent; P = 0·479), hospitalization (7 of 19 versus 6 of 23; RR 1·41, 0·57 to 3·49) or 1-year overall survival (80 versus 79 per cent; P = 0·839) for exercise and usual care respectively.
CONCLUSION


Exercise in the postoperative period is safe and may have the potential to improve physical fitness in patients with GOJ cancer. No differences in prognostic endpoints or HRQoL were observed. Registration number: NCT02722785 ( https://www.clinicaltrials.gov).",2020,"Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i.","['49 patients were studied', 'I-III GOJ cancer', 'patients with GOJ cancer', 'after oesophagectomy for cancer of the gastro-oesophageal junction', 'Patients with stage']","['postoperative concurrent aerobic and resistance training (exercise group) or usual care (control group', 'postoperative exercise training', 'Exercise', 'high-intensity exercise training', 'adjuvant chemotherapy']","['hospitalization', 'muscle strength and cardiorespiratory fitness', 'physical fitness', 'physical fitness, quality of life and treatment outcomes', 'prognostic endpoints or HRQoL', 'HRQoL', 'relative dose intensity of adjuvant chemotherapy', '1-year overall survival', 'cardiorespiratory fitness, muscle strength and HRQoL', 'Adherence to adjuvant chemotherapy, hospitalizations and 1-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",49.0,0.0909348,"Exercise was safe, with no differences in patients receiving adjuvant chemotherapy (14 of 16 versus 16 of 19; relative risk (RR) 1·04, 95 per cent c.i.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thorsen-Streit', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sundberg', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Djurhuus', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Mortensen', 'Affiliation': 'Departments of Oncology, Copenhagen, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Qvortrup', 'Affiliation': 'Departments of Oncology, Copenhagen, Denmark.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Svendsen', 'Affiliation': 'Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Heer', 'Affiliation': 'Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",BJS open,['10.1002/bjs5.50337']
1773,32858264,Flattening the Learning Curve: A Case-Based Video Orientation for a Subspeciality Residency Rotation.,"OBJECTIVE


To determine whether a clinically focused rotation orientation delivered through e-learning videos would be an effective method to improve residents' clinical knowledge and confidence.
METHODS


A pre-post study design evaluated for change in knowledge and confidence between a control and intervention group of residents assigned to outpatient pediatric endocrinology rotations at 2 residency programs from July 2017 to March 2019. The intervention group utilized the first morning of the rotation to complete the video curriculum designed to rapidly orient residents to common clinical management tasks in outpatient pediatric endocrinology.
RESULTS


A total of 35 of 41 residents (85%) completed the study (control group: 18/19 [95%]; intervention group: 17/22 [77%]). Score increase from pretest to post-test was significantly higher for intervention group compared to control group (+24.7% ± 12.1 vs +5.8% ± 7.9, P < .0001). Confidence increases were significantly higher in the intervention group compared to control group in 3 of 5 topics. Two themes illustrated residents' perspectives of this e-learning curriculum: 1) increase in foundational clinical knowledge and 2) improvement in efficiency of learning and patient care.
CONCLUSIONS


This clinically focused rotation orientation delivered through e-learning videos was an effective method to improve residents' clinical knowledge, without reliance on faculty to deliver this orientation throughout the academic year. Further studies should be pursued in various settings.",2020,"Score increase from pretest to posttest was significantly higher for intervention group compared to control group (+24.7 % ± 12.1 versus +5.8 % ± 7.9, p<.0001).",['group of residents assigned to outpatient pediatric endocrinology rotations at two residency programs from July 2017 to March 2019'],"['video curriculum designed to rapidly orient residents to common clinical management tasks', 'rotation orientation delivered through e-learning videos', 'control and intervention']",['foundational clinical knowledge; and 2) improvement in efficiency of learning and patient care'],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1658521', 'cui_str': 'Pediatric endocrinology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0425514,"Score increase from pretest to posttest was significantly higher for intervention group compared to control group (+24.7 % ± 12.1 versus +5.8 % ± 7.9, p<.0001).","[{'ForeName': 'Ranjit V', 'Initials': 'RV', 'LastName': 'Shenoy', 'Affiliation': ""Division of Pediatric Endocrinology, Department of Pediatrics, UCLA Mattel Children's Hospital (RV Shenoy), Los Angeles, Calif. Electronic address: Ranjit.Shenoy@nemours.org.""}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': ""Division of Pediatric Endocrinology, UCLA Children's Discovery Institute, David Geffen School of Medicine at UCLA (SD Mittelman), Los Angeles, Calif.""}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Relan', 'Affiliation': 'David Geffen School of Medicine at UCLA (A Relan), Los Angeles, Calif.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Reh', 'Affiliation': ""Children's Hospital of Orange County (CHOC), University of California (UC) Irvine (C Reh), Orange, Calif.""}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital (S Yazdani), Los Angeles, Calif. Dr Shenoy is now with Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Health System, Jacksonville, Fla.""}]",Academic pediatrics,['10.1016/j.acap.2020.08.013']
1774,32858333,Experimental sleep restriction increases somatic complaints in healthy adolescents.,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation. In this study, healthy adolescents (n = 30; 14-18yrs) completed a three-week, within-subject cross-over experiment. Following a sleep stabilization week, adolescents were randomized (in counterbalanced order) to five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout."" Somatic complaints were assessed via the Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT) concluding each condition. Adherence to experimental condition was confirmed via actigraphy. Adolescents slept two fewer hours and reported significantly greater frequency and severity of somatic complaints during the Insufficient Sleep (vs. Sufficient Sleep) condition. Restricting sleep opportunity to a level common in adolescence causally increased somatic complaints in otherwise healthy adolescents. Findings support clinical and preventative efforts to address pervasively inadequate sleep in adolescence.",2020,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","['otherwise healthy adolescents', 'healthy adolescents', 'healthy adolescents (n\xa0=\xa030; 14-18yrs']","['Experimental sleep restriction', 'five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout']","[""Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT"", 'Somatic complaints', 'frequency and severity of somatic complaints']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0189992,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA. Electronic address: kendrakrietsch@gmail.com.""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Center for Understanding Pediatric Pain (CUPP), Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Christopher.king@cchmc.org.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Dean.beebe@cchmc.org.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.020']
1775,32861015,Cognitive behavioral therapy for insomnia in restless legs syndrome patients.,"OBJECTIVES


The purpose of this study was to investigate the effects of cognitive behavioral therapy for insomnia (CBTI) in patients with Restless Legs Syndrome (RLS).
METHODS


This is a randomized controlled study. The patients were sequentially selected and randomly assigned to either a CBTI group or a non-CBTI group. A total of 25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center. Twelve were assigned to the CBTI group, and 13 were assigned to the non-CBTI group. The CBTI group received 4 sessions of behavioral therapy, while the non-CBTI group received one informative session on sleep hygiene. All patients completed sleep and psychiatric-related questionnaires. In addition, each individual completed a one-week sleep log for collecting subjective sleep data and actigraphy for objective sleep data.
RESULTS


After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group. The effect of CBTI on sleep-related data was maintained for up to three months.
CONCLUSIONS


CBTI was effective in RLS patients by improving sleep quality and anxiety symptoms. CBTI may be considered in clinical practice for RLS patients with comorbid insomnia.",2020,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","['restless legs syndrome patients', 'patients with Restless Legs Syndrome (RLS', 'RLS patients with comorbid insomnia', '25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center']","['CBTI', 'CBTI group or a non-CBTI', 'cognitive behavioral therapy', 'Cognitive behavioral therapy']","['sleep quality and anxiety symptoms', 'severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",25.0,0.0273384,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","[{'ForeName': 'Mei Ling', 'Initials': 'ML', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Daegu Health College, Daegu, South Korea; College of Nursing, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Kyung Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: kmp@kmu.ac.kr.'}, {'ForeName': 'Gholam K', 'Initials': 'GK', 'LastName': 'Motamedi', 'Affiliation': 'Department of Neurology, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University, School of Medicine, Daegu, South Korea. Electronic address: neurocho@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.011']
1776,32861189,Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy.,"OBJECTIVE/BACKGROUND


Clinical recommendations include putting infants to bed using a consistent bedtime routine at an appropriate hour to promote longer nighttime sleep. Actigraphy was used in this exploratory study to examine how bedtime routines and nighttime sleep onset were associated with nighttime total sleep time (TST) and efficiency from 6 to 24 weeks of age.
PATIENTS/METHODS


Infants (n = 24) wore sleep actigraphs for three, one-week periods at 6, 15, and 24 weeks of age. Nighttime TST, sleep efficiency, sleep onset and offset were quantified. Mothers reported on infant bedtime routines using the Brief Infant Sleep Questionnaire at each age. Multilevel models examined between- and within-person associations.
RESULTS


As infants aged, sleep onset was earlier, and bedtime routines became shorter (p's < 0.05). Infants fell asleep between 7 and 8:00PM on 24% of the nights. Most mothers (70%) reported that they often fed infants to sleep for the night. For every 1 h earlier in infants' usual sleep onset, nighttime TST was 34.4 min longer that night (p < 0.01). Infants with earlier than usual sleep onset had slightly earlier sleep offset the next morning (8.4 min for every 1 h earlier in onset; p = 0.02). Between-person analyses showed similar patterns. Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
CONCLUSION


Infants who fell asleep earlier also slept longer at night. Keeping infants up later in hopes of them sleeping in longer may be counterproductive.",2020,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
",['Infants (n\xa0'],[],"['Nighttime TST, sleep efficiency, sleep onset and offset', 'Time for bed', 'sleep onset, nighttime TST', 'Infants fell asleep', 'nighttime total sleep time (TST) and efficiency', 'sleep actigraphs', 'nighttime sleep duration', 'longer nighttime TST']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.041887,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Adams', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: elizabeth.adams@vcuhealth.org.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: jfs195@psu.edu.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Master', 'Affiliation': 'Department of Biobehavioral Health, Penn State University, University Park, PA, United States. Electronic address: lindsay.master@gmail.com.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': ""Department of Biobehavioral Health, Penn State University, University Park, PA, United States; Division of Sleep Medicine, Harvard Medical School, Boston, MA, United States; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: orfeu@psu.edu.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.003']
1777,32861668,High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients.,"OBJECTIVES


To determine the effects of exergaming on quality of life (QoL), motor, and clinical symptoms in subacute stroke patients.
DESIGN


A pseudorandomized controlled trial, using a before-after test design.
SETTING


University hospital.
PARTICIPANTS


Subacute, ischemic stroke outpatients (N=3857), 680 of whom were randomized and 641 completed the study.
INTERVENTIONS


We determined the effects of 5 times a week twice daily (EX2; 50 sessions; n=286) and once daily (EX1; 25 sessions; n=272) exergaming and low-intensity standard care (control [CON]; 25 sessions; n=83) on clinical, mobility, blood pressure (BP), and QoL outcomes.
MAIN OUTCOME MEASURES


The primary outcome was Modified Rankin Scale. Secondary outcomes were activities of daily living, 5 aspects of health-related QoL, Beck Depression Inventory, 6-minute walk test (6MWT), Berg Balance Scale (BBS), and static balance (center of pressure).
RESULTS


During exercise, the peak heart rate was 134, 134, and 126 beats per minute in the EX2, EX1, and CON groups, respectively. mRS improved similarly in the EX2 (-1.8; effect size, d=-4.0) and EX1 (-1.4; d=-2.6) groups, but more than in the CON group (-0.7; d=-0.6). QoL, Barthel Index, BBS, 6MWT, and standing posturography improved more in the EX2 group and the same in the EX1 and CON groups. Systolic and diastolic resting BP decreased more in the EX2 and EX1 groups than in the CON group. The intervention effects did not differ between men (n=349) and women (n=292).
CONCLUSIONS


Twice daily compared with once daily high-intensity exergaming or once daily lower intensity standard care produced superior effects on clinical and motor symptoms, BP, and QoL in male and female subacute ischemic stroke participants.",2020,"QoL, Barthel index, Berg balance scale, six-minute walk test, and standing posturography improved in a pattern of EX2>EX1=CON.","['University hospital setting', 'sub-acute stroke patients', 'males (n=349) and females (n=292', 'Of 3,857 sub-acute, ischemic stroke outpatients, 680 were randomized and 641 completed the study', 'male and female sub-acute ischemic stroke participants', '641 sub-acute ischemic stroke patients']",[],"['peak heart rate', 'Systolic and diastolic rBP', 'EX2', 'Activities of daily living (ADL), five aspects of health-related QoL(EQ-5D), Beck Depression Inventory (BDI), six-minute walk test (6MWT), Berg Balance Scale (BBS) and static balance (center of pressure, COP', 'clinical and motor symptoms, BP, and QoL', 'Modified Rankin Scale (mRS', 'QoL, Barthel index, Berg balance scale, six-minute walk test, and standing posturography', 'clinical, mobility, blood pressure (BP), and QoL outcomes', 'quality of life (QoL), motor, and clinical symptoms']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.18182,"QoL, Barthel index, Berg balance scale, six-minute walk test, and standing posturography improved in a pattern of EX2>EX1=CON.","[{'ForeName': 'József', 'Initials': 'J', 'LastName': 'Tollár', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary; University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary. Electronic address: tollarjozsef86@gmail.com.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Nagy', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary; University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary.'}, {'ForeName': 'Bence', 'Initials': 'B', 'LastName': 'Csutorás', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Nándor', 'Initials': 'N', 'LastName': 'Prontvai', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Nagy', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Török', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Blényesi', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Vajda', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary; University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary; Dr József Baka Diagnostical, Oncoradiological, Research and Educational Center, Kaposvár, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Farkas', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Béla E', 'Initials': 'BE', 'LastName': 'Tóth', 'Affiliation': 'Department of Pharmaceutical Surveillance and Economics, Faculty of Pharmacy, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Repa', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary; University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary; Dr József Baka Diagnostical, Oncoradiological, Research and Educational Center, Kaposvár, Hungary.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Moizs', 'Affiliation': 'Somogy County Móricz Kaposi Teaching Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Dávid', 'Initials': 'D', 'LastName': 'Sipos', 'Affiliation': 'University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary; Dr József Baka Diagnostical, Oncoradiological, Research and Educational Center, Kaposvár, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Kedves', 'Affiliation': 'Dr József Baka Diagnostical, Oncoradiological, Research and Educational Center, Kaposvár, Hungary.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Kovács', 'Affiliation': 'University of Pécs, Faculty of Health Sciences, Doctoral School of Health Sciences, Pécs, Hungary; Dr József Baka Diagnostical, Oncoradiological, Research and Educational Center, Kaposvár, Hungary; Department of Oncoradiology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'University of Groningen, University Medical Center, Groningen, The Netherlands.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.012']
1778,32862174,Importance and Assessment of Quality of Life in Symptomatic Permanent Atrial Fibrillation: Patient Focus Groups from the RATE-AF Trial.,"AIMS


To establish the extent and impact of symptoms in patients with atrial fibrillation (AF), the importance of different aspects of quality of life (QoL), and how we should assess wellbeing.
METHODS


Focus groups of patients with symptomatic permanent AF in a trial of heart rate control; the RATE-AF trial randomised 160 patients aged ≥60 years with permanent AF and at least NYHA class II dyspnoea to either digoxin or beta-blockers. Patient and public representatives led the focus groups and performed all data acquisition and analysis, using thematic approaches to interpret patient views about QoL and its measurement.
RESULTS


Substantial impairment of health-related QoL was noted in 160 trial patients, with impact on all domains apart from mental health. Eight women and 11 men aged 61-87 years participated in the focus groups. Common themes were a lack of information from healthcare professionals about AF, a lack of focus on QoL in consultations, and a sense of frustration, isolation, and reduced confidence. There was marked variability in symptoms in individual patients, with some describing severe impact on activities of daily living, and profound interaction with comorbidities such as arthritis. Day-to-day variation in QoL and difficulty in attributing symptom burden to AF or other comorbidities led to challenges in questionnaire completion. Consensus was reached that collecting both general and AF-specific QoL would be useful in routine practice, along with participation in peer support, which was empowering for the patients.
CONCLUSIONS


The impact of comorbidities is poorly appreciated in the context of AF, with considerable variability in QoL that requires both generic and AF-specific assessment. Improvement in QoL should direct the appraisal, and reappraisal, of treatment decisions for patients with permanent AF.",2020,"RESULTS


Substantial impairment of health-related QoL was noted in 160 trial patients, with impact on all domains apart from mental health.","['Focus groups of patients with symptomatic permanent AF in a trial of heart rate control; the RATE-AF trial randomised 160 patients aged ≥60 years with permanent AF and at least NYHA class II dyspnoea to either', 'patients with permanent AF', 'patients with atrial fibrillation (AF', 'Symptomatic Permanent Atrial Fibrillation', 'Eight women and 11 men aged 61-87 years participated in the focus groups']",['digoxin or beta-blockers'],"['Quality of Life', 'quality of life (QoL']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1959585', 'cui_str': 'Heart Rate Control'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0231804', 'cui_str': 'Dyspnea, class II'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.0847446,"RESULTS


Substantial impairment of health-related QoL was noted in 160 trial patients, with impact on all domains apart from mental health.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Patient and Public Involvement Team, RATE-AF trial, Birmingham, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stanbury', 'Affiliation': 'Patient and Public Involvement Team, RATE-AF trial, Birmingham, United Kingdom.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Haynes', 'Affiliation': 'Patient and Public Involvement Team, RATE-AF trial, Birmingham, United Kingdom.'}, {'ForeName': 'Karina V', 'Initials': 'KV', 'LastName': 'Bunting', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Lobban', 'Affiliation': 'Arrhythmia Alliance and Atrial Fibrillation Association, Chipping Norton, United Kingdom.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""St. George's University of London, London, United Kingdom.""}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Calvert', 'Affiliation': 'Institute of Applied Health Research & National Institute for Health Research Biomedical Research Centre, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Kotecha', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom, D.Kotecha@bham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology,['10.1159/000511048']
1779,32862232,The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.,"BACKGROUND


The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials.
METHODS


In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 were randomized to dapagliflozin 10 mg once daily or placebo. Mean eGFR was 43.1 mL/min/1.73 m2 and median UACR was 949 mg/g (108 mg/mmol).
RESULTS


Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1 mL/min/1.73 m2 lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR).
CONCLUSIONS


Participants with a wide range of underlying kidney diseases receiving renin-angiotensin system blocking therapy have been enrolled in the DAPA-CKD trial. The trial will examine the efficacy and safety of dapagliflozin in participants with CKD Stages 2-4 and increased albuminuria, with and without T2D.",2020,Mean eGFR was 43.1 mL/min/1.73 ,"['participants with CKD with and without type 2 diabetes (T2D', 'CKD after diabetes (n\u2009=\u20092510) were ischaemic/hypertensive nephropathy (n\u2009=\u2009687) and chronic glomerulonephritis (n\u2009=\u2009695), of which immunoglobulin', '4174 participants (97%) were receiving an', ' 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8', 'Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes', 'participants with CKD Stages 2-4 and increased albuminuria, with and without T2D', 'Participants with a wide range of underlying kidney diseases receiving', 'chronic kidney disease (DAPA-CKD', '2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes', '4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200']","['dapagliflozin 10\u2009mg once daily or placebo', 'renin-angiotensin system blocking therapy', 'glucagon-like peptide 1 receptor agonists', 'angiotensin-converting enzyme inhibitor or angiotensin receptor blocker', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin', 'dapagliflozin']","['Kidney Failure and Disease Progression', 'efficacy and safety', 'glomerular filtration rate (eGFR', 'kidney and cardiovascular events', 'Mean eGFR', 'm2 and median UACR', 'mean eGFR']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0848548', 'cui_str': 'Hypertensive renal disease'}, {'cui': 'C0152451', 'cui_str': 'Chronic glomerulonephritis'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4304.0,0.0859358,Mean eGFR was 43.1 mL/min/1.73 ,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Batiushin', 'Affiliation': 'Department of Nephrology, Rostov State Medical University, Rostov, Russia.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Bilchenko', 'Affiliation': 'Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Douthat', 'Affiliation': 'Department of Nephrology, Hospital Privado Universitario de Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Escudero', 'Affiliation': 'Division of Nephrology, Hospital Arzobispo Loayza, Cayetano Heredia University, Lima, Peru.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Furuland', 'Affiliation': 'Department of Medical Sciences Renal Unit, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Górriz', 'Affiliation': 'Department of Nephrology, University Clinic Hospital, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Haller', 'Affiliation': 'Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, Division of Nephrology, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.'}, {'ForeName': 'Shin-Wook', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Rey', 'Initials': 'R', 'LastName': 'Isidto', 'Affiliation': 'Healthlink Medical, Dental, Surgical Clinics and Diagnostics Center, Iloilo City, Philippines.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khullar', 'Affiliation': 'Department of Nephrology and Renal Transplant Medicine, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Nowicki', 'Affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kausik', 'Initials': 'K', 'LastName': 'Umanath', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Pham', 'Initials': 'P', 'LastName': 'Van Bui', 'Affiliation': 'Pham Ngoc Thach Medicine University, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Wittmann', 'Affiliation': 'Second Department of Medicine and Nephrology-Diabetes Center, University of Pécs Medical School, Pécs, Hungary.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa234']
1780,32866928,"RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis.","Recurrent pericarditis (RP) occurs in 15% to 30% of patients following a first episode, despite standard treatment with nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids; many patients become dependent on corticosteroids. Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP. RHAPSODY, a double-blind, placebo-controlled, randomized-withdrawal (RW) pivotal Phase 3 trial (NCT03737110), enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C-reactive protein ≥1 mg/dL at screening. After a subcutaneous loading dose (adults, 320 mg; children, 4.4 mg/kg), all patients receive blinded weekly subcutaneous rilonacept (adults, 160 mg; children, 2.2 mg/kg) during the run-in period. Patients must taper and discontinue concomitant pericarditis medications during the blinded run-in period and achieve clinical response (C-reactive protein ≤0.5 mg/dL and weekly average NRS ≤2.0 during the 7 days prior to and including the day of randomization) by end of the run-in (while on rilonacept monotherapy) to be randomized to either continued rilonacept or placebo in the RW period. Primary efficacy end point was time to adjudicated pericarditis recurrence during the RW period; secondary efficacy end points were proportion of patients maintaining clinical response, percentage of days with NRS ≤2, and percentage of patients with no-to-minimal pericarditis symptoms at week 16 of the RW period. Safety evaluations include adverse event monitoring, physical examinations, and laboratory tests. The RHAPSODY trial will evaluate the efficacy and safety of rilonacept in the treatment of RP to improve outcomes and patient health-related quality of life.",2020,"Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP.","['enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C-reactive protein ≥1 mg/dL at screening', 'patients with recurrent pericarditis']","['rilonacept or placebo', 'Rilonacept (KPL-914', 'blinded weekly subcutaneous rilonacept', 'placebo', 'rilonacept', 'colchicine, and corticosteroids']","['adverse event monitoring, physical examinations, and laboratory tests', 'time to adjudicated pericarditis recurrence', 'Recurrent pericarditis (RP', 'proportion of patients maintaining clinical response, percentage of days with NRS ≤2, and percentage of patients with no-to-minimal pericarditis symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C2343589', 'cui_str': 'rilonacept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.110477,"Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP.","[{'ForeName': 'Allan L', 'Initials': 'AL', 'LastName': 'Klein', 'Affiliation': 'Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH. Electronic address: kleina@ccf.org.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Imazio', 'Affiliation': 'University Cardiology, Cardiovascular and Thoracic Department, AOU Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brucato', 'Affiliation': 'Department of Biomedical and Clinical Science, University of Milano, Fatebenefratelli Hospital, Milan, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'LeWinter', 'Affiliation': 'Cardiology Unit, The University of Vermont Medical Center, The University of Vermont, Burlington, VT.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'University of Genoa and G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Kiniksa Pharmaceuticals Ltd., Hamilton, Bermuda.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'NJS Associates, Bridgewater, NJ.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Gervais', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Perrin', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Paolini', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}]",American heart journal,['10.1016/j.ahj.2020.07.004']
1781,32847924,'There were some clues': a qualitative study of heuristics used by parents of adolescents to make credibility judgements of online health news articles citing research.,"OBJECTIVE


To identify how parents judge the credibility of online health news stories with links to scientific research.
DESIGN


This qualitative study interviewed parents who read online stories about e-cigarettes and human papillomavirus (HPV) vaccination published by top-tier US news organisations. Researchers asked participants to describe elements of a story that influenced their judgement about content credibility. Researchers analysed transcripts using inductive and deductive techniques. Deductive analysis drew on cognitive heuristics previously identified as being used by the public to judge online health information. Inductive analysis allowed the emergence of new heuristics, especially relating to health.
SETTING


The US National Cancer Institute's Audience Research Lab in Maryland, in August-November 2018.
PARTICIPANTS


Sixty-four parents with at least one child between the ages of 9 and 17 residing in Maryland, Virginia, or the District of Columbia participated. Researchers randomly assigned 31 parents to the HPV vaccination story and 33 to the e-cigarette story.
RESULTS


Evidence of existing heuristics, including reputation, endorsement, consistency, self-confirmation, expectancy violation and persuasive intent emerged from the interviews, with participants deeming stories credible when mentioning physicians (reputation heuristic) and/or consistent with information provided by personal physicians (consistency heuristic). Participants also described making credibility judgements based on presence of statistics, links to scientific research and their general feelings about news media. In relation to presence of statistics and links, participants reported these elements increased the credibility of the news story, whereas their feelings about the news media decreased their credibility judgement.
CONCLUSIONS


Parents used a constellation of heuristics to judge the credibility of online health news stories. Previously identified heuristics for online health information are also applicable in the context of health news stories. The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.",2020,"The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.","[""The US National Cancer Institute's Audience Research Lab in Maryland, in August-November 2018"", 'Sixty-four parents with at least one child between the ages of 9 and 17 residing in Maryland, Virginia, or the District of Columbia participated', 'parents who read online stories about e-cigarettes and human papillomavirus (HPV) vaccination published by top-tier US news organisations']",['HPV vaccination story and 33 to the e-cigarette story'],[],"[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0004281', 'cui_str': 'Audience Research'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]",[],64.0,0.030133,"The findings have implications for initiatives in education, health communication and journalism directed towards increasing the public's engagement with health news and their credibility judgements.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Maggio', 'Affiliation': 'Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA lauren.maggio@usuhs.edu.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Krakow', 'Affiliation': 'Population Health, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Moorhead', 'Affiliation': 'Journalism, San Francisco State University, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039692']
1782,32847927,Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II).,"INTRODUCTION


Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Over the past 20 years, a number of new drugs have been approved for National Health Service (NHS) use on the basis of information from short-term trials that demonstrate efficacy. These trials do not provide information about the longer term outcomes, which inform treatment policy. This trial will assess the long-term clinical and cost-effectiveness of the newer treatment levetiracetam and zonisamide.
METHODS AND ANALYSIS


This is a phase IV, multicentre, open-label, randomised, controlled clinical trial comparing new and standard treatments for patients with newly diagnosed epilepsy. Arm A of the trial randomised 990 patients with focal epilepsy to standard AED lamotrigine or new AED levetiracetam or zonisamide. Arm B randomised 520 patients with generalised epilepsy to standard AED sodium valproate or new AED levetiracetam. Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics. Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs. Patients are followed up for a minimum of 2 years. The primary outcome is time to 12-month remission from seizures. Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life. All primary analyses will be on an intention to treat basis. Separate analyses will be undertaken for each arm. Health economic analysis will be conducted from the perspective of the NHS to assess the cost-effectiveness of each AED.
ETHICS AND DISSEMINATION


This trial has been approved by the North West-Liverpool East REC (Ref. 12/NW/0361). The trial team will disseminate the results through scientific meetings, peer-reviewed publications and patient and public involvement.
TRIAL REGISTRATION NUMBERS


EudraCT 2012-001884-64; ISRCTN30294119.",2020,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"['520 patients with generalised epilepsy to', 'epilepsy', 'Included patients are aged 5 years or older with two or more spontaneous seizures requiring AED monotherapy, who are not previously treated with AEDs', '990 patients with focal epilepsy to', 'Patients are recruited from UK NHS outpatient epilepsy, general neurology and paediatric clinics', 'patients with newly diagnosed epilepsy']","['standard AED sodium valproate or new AED levetiracetam', 'standard AED lamotrigine or new AED levetiracetam or zonisamide', 'levetiracetam and zonisamide', 'zonisamide']","['time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life', 'effectiveness and cost-effectiveness', 'time to 12-month remission from seizures']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",990.0,0.298206,Secondary outcomes include time to treatment failure (including due to inadequate seizure control or unacceptable adverse reactions); time to first seizure; time to 24-month remission; adverse reactions and quality of life.,"[{'ForeName': 'Silviya', 'Initials': 'S', 'LastName': 'Balabanova', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Sills', 'Affiliation': 'School of Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Phil E M', 'Initials': 'PEM', 'LastName': 'Smith', 'Affiliation': 'Department of Neurology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': ""Paediatric Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Leach', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of Brain Sciences, Imperial College London Faculty of Medicine-South Kensington Campus, London, UK.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Pharmacology, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur-Smith', 'Affiliation': 'Biostatistics, University of Liverpool, Faculty of Health and Life Sciences, Liverpool, UK.'}, {'ForeName': 'Anthony Guy', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK marjon01@liverpool.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-040635']
1783,32853559,"Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
METHODS


MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.
FINDINGS


Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.
INTERPRETATION


Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","['2595 women were identified as being eligible for the MifeMiso trial', '59 (17%) of 348 women in the', '696 (98%) of 711 women had available data for the primary outcome', 'Women with missed miscarriage', '354 women', 'Between Oct 3, 2017, and July 22, 2019', '28 UK hospitals', '62 (17%) of 355 women in the', 'maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre', 'missed miscarriage (MifeMiso', '711 women', 'Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent']","['mifepristone and misoprostol', 'mifepristone plus misoprostol', 'Mifepristone and misoprostol', 'prostaglandin misoprostol', 'misoprostol', 'mifepristone', 'placebo', 'placebo and misoprostol', 'placebo plus misoprostol', 'oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol']","['chance of successful miscarriage management', 'failure to spontaneously pass the gestational sac', 'surgical intervention', 'incidence of adverse events', 'gestational sac spontaneously', 'rate of completion of missed miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C0069304', 'cui_str': 'POU5F1 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0948766', 'cui_str': 'Ultrasound pelvis'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1126026', 'cui_str': 'Mifepristone 200 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}]",2595.0,0.70251,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Chu', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Electronic address: a.j.devall@bham.ac.uk.'}, {'ForeName': 'Leanne E', 'Initials': 'LE', 'LastName': 'Beeson', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'C Okeke', 'Initials': 'CO', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'La Fontaine Papadopoulos', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'The Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's Charity, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Naftalin', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster NHS Foundation Trust, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Hassan', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Yadava', 'Initials': 'Y', 'LastName': 'Jeve', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': ""Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford NHS Trust, Telford, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Department of Reproductive Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chitra S', 'Initials': 'CS', 'LastName': 'Kumar', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Small', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Pringle', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hodge', 'Affiliation': 'Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31788-8']
1784,32856226,"Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial.","INTRODUCTION


To compare blood glucose variability (GV) in Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with metformin monotherapy after twice-daily exenatide or biphasic insulin aspart 30 (BIAsp30).
METHODS


In this 16-week multicenter, randomized clinical trial, 104 participants were randomized 1:1 to receive exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily. All participants continued metformin treatment. The primary outcome was the change in GV as measured by a continuous glucose monitoring system (CGMS) from baseline to 16 weeks.
RESULTS


At 16 weeks, both the Exenatide and BIAsp30 groups effectively decreased mean glucose (MG), but neither group changed the mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG). The decrease in 2-h post-breakfast glucose excursions was greater in the Exenatide group compared to the BIAsp30 group, with a least square (LS) mean difference [95% CI] of (1.58 [0.53, 2.63]). Exenatide also significantly reduced 2-h post-lunch glucose excursion compared to BIAsp30 (LS mean difference [95% CI], 1.19 [0.18, 2.20]). The Exenatide group had significantly reduced body weight and body mass index (BMI), while the BIAsp30 group had increased weight and had no change in BMI. Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
CONCLUSION


Although there was no difference in change of GV between Exenatide and BIAsp30, exenatide provided more improvement in postprandial glucose excursion and weight control, without increasing the risk of hypoglycemia in Chinese patients with T2DM whose blood glucose was inadequately controlled with metformin. These findings may provide new options for patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions.
TRIAL REGISTRATION


ClinicalTrials.gov indentifier: NCT02449603.",2020,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","['104 participants', 'Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with', 'Chinese patients with T2DM whose blood glucose was inadequately controlled with', 'Chinese Participants with Type 2 Diabetes Inadequately Controlled with', 'patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions']","['exenatide or biphasic insulin aspart 30 (BIAsp30', 'Metformin Monotherapy', 'metformin monotherapy', 'Exenatide', 'Exenatide and Biphasic Insulin Aspart', 'metformin', 'exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily']","['BMI', 'weight', 'change in GV as measured by a continuous glucose monitoring system (CGMS', '2-h post-breakfast glucose excursions', 'tolerated with no serious hypoglycemic events', 'hypoglycemic events', 'risk of hypoglycemia', 'blood glucose variability (GV', 'Blood Glucose Variability', 'mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG', '2-h post-lunch glucose excursion', 'body weight and body mass index (BMI', 'mean glucose (MG', 'postprandial glucose excursion and weight control']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C2003521', 'cui_str': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0356369', 'cui_str': 'Biphasic insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]",104.0,0.0577427,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Shaanxi Aerospace Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xi'an Chang an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Yan'an People's Hospital, Yan'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shangluo Central Hospital, Shangluo, Shaanxi, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology, Xi'an Central Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qingzhen', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Endocrinology, Xi'an Gaoxin Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China. qiuheji@hotmail.com.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00904-z']
1785,32858210,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" [Int. J. Surg. 80 (2020) 13-18].",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: ymc19950616@163.com.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zichuanding@163.com.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zongke2017@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.067']
1786,32861537,"The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma.","BACKGROUND


In the phase 3 trial ARIEL3, maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib provided clinical benefit versus placebo for patients with recurrent, platinum-sensitive ovarian cancer. Here, we evaluate the impact of age on the clinical utility of rucaparib in ARIEL3.
METHODS


Patients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy were enrolled in ARIEL3 and randomized 2:1 to rucaparib 600 mg twice daily or placebo. Exploratory, post hoc analyses of progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety were conducted in three age subgroups (<65 years, 65-74 years, and ≥75 years).
RESULTS


Investigator-assessed PFS was significantly longer with rucaparib than placebo in patients aged <65 years (rucaparib n = 237 vs placebo n = 117; median, 11.1 vs 5.4 months; hazard ratio [HR]: 0.33 [95% confidence interval (95% CI) 0.25-0.43]; P < 0.0001) and 65-74 years (n = 113 vs n = 64; median, 8.3 vs 5.3 months; HR 0.43 [95% CI 0.29-0.63]; P < 0.0001) and numerically longer in patients aged ≥75 years (n = 25 vs n = 8; median, 9.2 vs 5.5 months; HR 0.47 [95% CI 0.16-1.35]; P = 0.1593). QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups. Safety of rucaparib was generally similar across the age subgroups.
CONCLUSIONS


Efficacy, patient-centered outcomes, and safety of rucaparib were similar between age subgroups, indicating that all eligible women with recurrent ovarian cancer should be offered this therapeutic option, irrespective of age. https://clinicaltrials.gov/ct2/show/NCT01968213.",2020,QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups.,"['patients with recurrent ovarian carcinoma', 'eligible women with recurrent ovarian cancer', 'three age subgroups (<65\xa0years, 65-74\xa0years, and ≥75\xa0years', 'patients with recurrent, platinum-sensitive ovarian cancer', 'patients aged <65\xa0years (rucaparib n\xa0=\xa0237 vs placebo n\xa0', 'Patients with platinum-sensitive, recurrent ovarian carcinoma with ≥2 prior platinum-based chemotherapies who responded to their last platinum-based therapy']","['rucaparib 600\xa0mg twice daily or placebo', 'rucaparib', 'placebo', 'poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib']","['progression-free survival (PFS), patient-centered outcomes (quality-adjusted PFS [QA-PFS] and quality-adjusted time without symptoms or toxicity [Q-TWiST]), and safety', 'Safety of rucaparib', 'QA-PFS and Q-TWiST', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3661315', 'cui_str': 'rucaparib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661315', 'cui_str': 'rucaparib'}]",,0.375328,QA-PFS and Q-TWiST were significantly longer with rucaparib than placebo across all age subgroups.,"[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, via Ripamonti 435, 20146 Milan, Italy. Electronic address: nicoletta.colombo@ieo.it.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Ave, Toronto, ON, Canada.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Gynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Institute of Oncology, C/Natzaret, 115-117, 08035 Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Department of Medical Oncology, St John of God Hospital Subiaco, 12 Salvado Rd, Subiaco, WA 6008, Australia.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Division of Gynecologic Oncology, Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester M20 4BX, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Gynecologic Oncology Unit, Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Leary', 'Affiliation': ""Gynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), 98405 Villejuif, France.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Holloway', 'Affiliation': 'Gynecologic Oncology, Advent Health Cancer Institute, 601 East Rollins St, Orlando, FL 32803, USA.'}, {'ForeName': 'Margarita Amenedo', 'Initials': 'MA', 'LastName': 'Gancedo', 'Affiliation': 'Medical Oncology Department, Oncology Center of Galicia, Rúa Doctor Camilo Veiras, 1, 15009 La Coruña, Spain.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fong', 'Affiliation': 'Medical Oncology Department, Auckland City Hospital, Grafton, 2 Park Road, Grafton, Auckland 1023, New Zealand.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, and University of Queensland, Cnr Butterfield St and Bowen Bridge Rd, Herston, QLD 4029, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Gynecologic Oncology, James Cancer Center, The Ohio State University, Starling-Loving Hall, 320 West 10th Ave, Columbus, OH 43210, USA.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Armstrong', 'Affiliation': 'Gynecology and Obstetrics, Johns Hopkins University Medical Center, 601 N Caroline St, Baltimore, MD 21287, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'García-Donas', 'Affiliation': 'Division of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Calle Oña 10, 28050 Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, University of Washington, 1959 NE Pacific Street, Box 356460, Seattle, WA 98195, USA.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meunier', 'Affiliation': 'Modus Outcomes, 61 Cours de la Liberte, 69003 Lyon, France.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Cameron', 'Affiliation': 'Clinical Science, Clovis Oncology UK Ltd., Granta Centre, Granta Park, Great Abington, Cambridge CB21 6GP, UK.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Maloney', 'Affiliation': 'Clinical Development, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Goble', 'Affiliation': 'Biostatistics, Clovis Oncology, Inc., 5500 Flatiron Parkway, Boulder, CO 80301, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bedel', 'Affiliation': 'Pricing & Market Access - Europe, Clovis Oncology Switzerland GmBH, Seefeldstrasse 69, 8008 Zurich, Switzerland.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, 72 Huntley St, London WC1E 6DD, UK.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.045']
1787,32868350,Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial.,"OBJECTIVE


To predict antibiotic use after initial treatment with ibuprofen using data from a randomised controlled trial comparing ibuprofen to pivmecillinam in the treatment of women with symptoms of an uncomplicated urinary tract infection (UTI).
SETTING


16 sites in a primary care setting in Norway, Sweden and Denmark.
PARTICIPANTS


Data from 181 non-pregnant women aged 18-60 presenting with symptoms of uncomplicated UTI, initially treated with ibuprofen.
METHODS


Using the least absolute shrinkage and selection operator logistic regression model, we conducted analyses to see if baseline information could help us predict which women could be treated with ibuprofen without risking treatment failure and which women should be recommended antibiotics.
RESULTS


Of the 143 women included in the final analysis, 77 (53.8%) recovered without antibiotics and 66 (46.2 %) were subsequently prescribed antibiotics. In the unadjusted binary logistic regression, the number of days with symptoms before inclusion (<3 days) and feeling moderately unwell or worse (≥4 on a scale of 0-6) were significant predictors for subsequent antibiotic use. In the adjusted model, no predictors were significantly associated with subsequent antibiotic use. The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
CONCLUSION


We did not find any baseline information that significantly predicted the use of antibiotic treatment. Identifying women who need antibiotic treatment to manage their uncomplicated UTI is still challenging. Larger data sets are needed to develop models that are more accurate.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT01849926).",2020,"The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
","['143 women included in the final analysis, 77 (53.8%) recovered without antibiotics and 66 (46.2 %) were subsequently prescribed antibiotics', 'uncomplicated urinary tract infection', '16 sites in a primary care setting in Norway, Sweden and Denmark', 'Data from 181 non-pregnant women aged 18-60 presenting with symptoms of uncomplicated UTI, initially treated with', 'women with symptoms of an uncomplicated urinary tract infection (UTI']",['ibuprofen'],[],"[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],181.0,0.154871,"The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
","[{'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Vik', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway ingvild.vik@medisin.uio.no.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bollestad', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gloria Cristina', 'Initials': 'GC', 'LastName': 'Cordoba', 'Affiliation': 'Section of General Practice and Research Unit of General Practice, Department of Public Health, University of Copenhagen, København, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'Section of General Practice and Research Unit of General Practice, Department of Public Health, University of Copenhagen, København, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neumark', 'Affiliation': 'Primary Health Care and Planning Division, Kalmar County Council, Kalmar, Sweden.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Damsgaard', 'Affiliation': 'Bergen Accident and Emergency Department, Bergen Kommune, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bærheim', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Hordaland, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Grude', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbaek', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-035074']
1788,32868354,Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect.,"INTRODUCTION


Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.
METHODS AND ANALYSIS


This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.
ETHICS AND DISSEMINATION


This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
TRIAL REGISTRATION NUMBER


NCT03288246.",2020,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","['Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes', 'adolescents and youth living with HIV in Haiti', '150 participants ages 10-24 who have been on ART for >6 months']","['POC VL testing', 'POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling', 'standard laboratory-based VL testing', 'laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1\u2009month later, at which time they receive ART adherence counselling']",['VL suppression'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",150.0,0.15321,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","[{'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Reif', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA lir2020@med.cornell.edu.'}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Severe', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Joseph Marie', 'Initials': 'JM', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Apollon', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Elul', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036147']
1789,32868356,R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV).,"INTRODUCTION


Hepatitis C virus (HCV) is a global public health threat, and novel models of care are required to treat those currently or previously at highest risk of infection, particularly persons who inject drugs (PWID; ever injected), as conventional healthcare models do not have the reach to deliver cure of HCV to disadvantaged, disproportionately affected communities. In Western Europe and Australasia, it is estimated that HCV affects between 0.4% and 1.0% of the regions' populations, accordingly, it affects between 0.4% and 0.7% of the populations of countries in this study (Scotland, Wales and Australia).  R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV (REACH HCV) will evaluate community pharmacy-based diagnostic outreach and HCV treatment against conventional HCV testing and treatment pathways for clients receiving opioid substitution therapy (OST) in community pharmacies.
METHODS AND ANALYSIS


REACH HCV is an international multicentre cluster randomised controlled trial with sites in Scotland, Wales and Australia. The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway. Participants are recruited from OST clients in these pharmacies.In the pharmacy intervention pathway, participants receive a rapid point-of-care HCV PCR test in their pharmacy by a study outreach nurse. If positive, direct-acting antivirals (DAAs) are delivered to participants via their pharmacist in line with their OST schedule.In the education-only pathway, pharmacists counsel OST clients on HCV and refer them to the nearest nurse-led clinic or general practitioner offering HCV testing according to standard care protocols. If positive, DAAs are delivered as in the intervention pathway.The primary endpoint for both pathways is sustained viral response at 12 weeks post-treatment . Secondary outcomes are: cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions.A statistical analysis plan will be finalised prior to data lock. Analysis will be by intention to treat (ITT) to show superiority. Modified ITT analysis will also be undertaken to explore the steps in the pathways.
ETHICS AND DISSEMINATION


The trial received ethical favourable opinion from the East of Scotland Research Ethics Committee 2 (19/ES/0025) for UK sites and approval from the Alfred Hospital Ethics Committee (148/19) for Australian sites and complies with principles of Good Clinical Practice. Final results will be presented in peer-reviewed journals and at relevant conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry NCT03935906.
PROTOCOL VERSION


V.4.0-19 March 2020.",2020,The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway.,"['VERSION\n\n\nV.4.0-19 March 2020', 'clients receiving opioid substitution therapy (OST) in community pharmacies', 'Participants are recruited from OST clients in these pharmacies']","['direct-acting antivirals (DAAs', 'R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV', 'HCV', 'pharmacy intervention pathway or the education-only (control) pathway', 'rapid point-of-care HCV PCR test', 'HCV (REACH HCV']","['sustained viral response', 'cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions']","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]","[{'cui': 'C3888663', 'cui_str': 'Sustained viral response'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.122577,The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Byrne', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK c.x.byrne@dundee.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK.'}, {'ForeName': 'Sarah Karen', 'Initials': 'SK', 'LastName': 'Inglis', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Lewis J Z', 'Initials': 'LJZ', 'LastName': 'Beer', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Nicki', 'Initials': 'N', 'LastName': 'Palmer', 'Affiliation': 'Public Health Wales Department of Microbiology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Minh Duc', 'Initials': 'MD', 'LastName': 'Pham', 'Affiliation': 'Disease Elimination Programme, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Healy', 'Affiliation': 'Public Health Wales Department of Microbiology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Doyle', 'Affiliation': 'Disease Elimination Programme, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donnan', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036501']
1790,32868360,Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study).,"INTRODUCTION


Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings.
METHODS AND ANALYSIS


RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA.
ETHICS AND DISSEMINATION


This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities.
TRIAL REGISTRATION DETAILS


Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018.",2020,"Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%.","['20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20', 'Australian New Zealand Clinical Trials Registry']","['ivermectin', 'Ivermectin', 'ivermectin-based MDA', 'ivermectin-based mass drug administration (MDA']","['impetigo prevalence', 'prevalence of scabies', 'global morbidity']","[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0162627', 'cui_str': 'Bacterial infection of skin'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.330964,"Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%.","[{'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Lake', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Phelan', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Engelman', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sokana', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Nasi', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Dickson', 'Initials': 'D', 'LastName': 'Boara', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gorae', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Schuster', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Grobler', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Millicent H', 'Initials': 'MH', 'LastName': 'Osti', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Whitfeld', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romani', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kaldor', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Steer', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia andrew.steer@rch.org.au.'}]",BMJ open,['10.1136/bmjopen-2020-037305']
1791,32869577,[Analysis of the clinical effect on post-stroke shoulder hand syndrome stage Ⅰ treated with the along-meridian trochar acupuncture therapy].,"OBJECTIVE


To compare the differences in the clinical effect on post-stroke shoulder hand syndrome (SHS) stage Ⅰ between the along-meridian trochar acupuncture therapy and the routine acupuncture therapy with filiform needles.
METHODS


A total of 80 patients with post-stroke SHS stage I were divided into a treatment group (41 cases) and a control group (39 cases) according to the random number table. In the control group, the common filiform needles were used to stimulate Jianyu (LI15), Jianliao (TE14), Jianzhen (SI9), Jianzhongshu (SI15), Jianwaishu (SI14), 5 times a week, 3 weeks as 1 course. In the treatment group, along-meridian trochar acupuncture therapy was applied, 3 times a week, 3 weeks as 1 course. The patients in both groups were all treated with basic medications and routine rehabilitation training. Pain degree, edema degree, upper limb motor function and activity of daily living were observed in the two groups before the treatment, at the end of the treatment and in follow-up. At the end of treatment and in follow-up, the therapeutic effect was evaluated respectively in the patients of the two groups.
RESULTS


Compared with the values before treatment, the VAS score of the upper limb was reduced obviously ( P < 0.001), the score of the upper limb motor function and Barthel index were increased obviously ( P <0.001,  P <0.05) in the patients of the two groups, the score of edema degree of the affected limb was reduced after treatment in the patients of the treatment group ( P <0.001). Compared with the control group, VAS score of the upper limb and the score of edema degree of the affected limb were obviously lower ( P <0.001), and the score of the upper limb motor function and Barthel index were obviously higher in the treatment group ( P <0.001). The total effective rate was 66.7% (26/39) after treatment and was 74.4% (29/39) in follow-up in the treatment group and they were 20.5% (8/39) and 28.2% (11/39) respectively in the control group. The total effective rates after treatment and in follow-up in the treatment group were all obviously higher than those in the control group respectively ( P <0.001).
CONCLUSION


The along-meridian trochar acupuncture therapy remarkably relieves pain and edema and improves the upper limb motor function and the activity of daily living in the patients with post-stroke shoulder hand syndrome and its clinical therapeutic effect is definite.",2020,"the score of the upper limb motor function and Barthel index were increased obviously ( P <0.001,  P <0.05) in the patients of the two groups, the score of edema degree of the affected limb was reduced after treatment in the patients of the treatment group ( P <0.001).",['80 patients with post-stroke SHS stage I'],"['meridian trochar acupuncture therapy', 'basic medications and routine rehabilitation training']","['score of edema degree of the affected limb', 'therapeutic effect', 'total effective rate', 'Pain degree, edema degree, upper limb motor function and activity of daily living', 'stimulate Jianyu (LI15), Jianliao (TE14), Jianzhen (SI9), Jianzhongshu (SI15), Jianwaishu (SI14', 'VAS score of the upper limb', 'pain and edema and improves the upper limb motor function and the activity of daily living', 'total effective rates', 'score of the upper limb motor function and Barthel index', 'VAS score of the upper limb and the score of edema degree of the affected limb']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034931', 'cui_str': 'Complex regional pain syndrome type I'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0450588', 'cui_str': 'SI14'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",80.0,0.0237905,"the score of the upper limb motor function and Barthel index were increased obviously ( P <0.001,  P <0.05) in the patients of the two groups, the score of edema degree of the affected limb was reduced after treatment in the patients of the treatment group ( P <0.001).","[{'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Cao', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'School of Life Sciences, 3School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'He', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Huguosi Hospital of Traditional Chinese Medicine Affiliated to Beijing University of Chinese Medicine, Beijing 100035, China.'}, {'ForeName': 'Zi-Wei', 'Initials': 'ZW', 'LastName': 'Chen', 'Affiliation': 'School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.200164']
1792,32869578,[Therapeutic effect of scalp acupuncture combined with rehabilitation training on balance dysfunction in children with spastic hemiplegia].,"OBJECTIVE


To investigate the therapeutic effect of scalp acupuncture and rehabilitation training on balance dysfunction in children with spasmodic hemiplegia so as to provide the reference to the optimization of treatment scheme.
METHODS


A total of 60 children with spastic hemiplegia were divided into a routine group and a scalp acupuncture group, 30 cases in each one according to random number table. In the routine group, the rehabilitation training was provided, including exercise training, balance training, spasmotherapy apparatus, electromyography biofeedback apparatus and orthoses. In the scalp acupuncture group, on the base of the treatment as the routine group, scalp acupuncture was supplemented at motor area, foot motor sensory area, equilibrium area and parietal temporal anterior oblique line. Separately, before the treatment, after 3 months treatment and after 6 months treatment, the dimension D and E of the gross motor function measure-88 (GMFM-88) and Berg balance scale (BBS) were adopted to evaluate balance related motor functions and equilibrium function. The differences in the above 3 indicators at different time stages were compared in children between the two groups.
RESULTS


Compared with the score before the treatment, BBS score was obviously increased after 3 and 6 months treatment in the patients of the two groups respectively ( P <0.05). The score in the dimension D and E after 6-month treatment was increased significantly as compared with the score before treatment and after 3-month treatment in the same group respectively ( P <0.05). Compared with the routine group, the score of dimension D and E of GMFM-88 as well as BBS score were all increased obviously in the scalp acupuncture group after 3 and 6 months treatment ( P <0.05).
CONCLUSION


On the base of routine rehabilitation training, scalp acupuncture can improve balance function of children with spastic hemiplegia better.",2020,The score in the dimension D and E after 6-month treatment was increased significantly as compared with the score before treatment and after 3-month treatment in the same group respectively ( P <0.05).,"['children with spasmodic hemiplegia', 'children with spastic hemiplegia better', '60 children with spastic hemiplegia', 'children with spastic hemiplegia']","['scalp acupuncture and rehabilitation training', 'rehabilitation training was provided, including exercise training, balance training, spasmotherapy apparatus, electromyography biofeedback apparatus and orthoses', 'scalp acupuncture combined with rehabilitation training', 'routine rehabilitation training, scalp acupuncture', 'scalp acupuncture']","['score of dimension D and E of GMFM-88 as well as BBS score', 'balance function', 'BBS score', 'balance dysfunction', 'dimension D and E of the gross motor function measure-88 (GMFM-88) and Berg balance scale (BBS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0154694', 'cui_str': 'Spastic hemiplegia'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",60.0,0.0128227,The score in the dimension D and E after 6-month treatment was increased significantly as compared with the score before treatment and after 3-month treatment in the same group respectively ( P <0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}, {'ForeName': 'Pao-Qiu', 'Initials': 'PQ', 'LastName': 'Wang', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Liu', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}, {'ForeName': 'Yi-Mei', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': ""Hunan Children's Hospital, Changsha 410007,China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190461']
1793,32869579,"[Treatment of scapulohumeral periarthritis by ""metal hook fishing""-like needling technique combined with Tuina manipulation].","OBJECTIVE


To observe the clinical effect of ""metal hook fishing"" (MHF)-like needling technique combined with Tuina manipulation in the treatment of scapulohumeral periarthritis.
METHODS


A total of 72 patients with scapulohumeral periarthritis were randomly divided into MHF-like needling (MHF) and conventional needling groups ( n =36 in each group). For patients of the GHF group, the doctor pressed the acupoint with the left index finger, held the disposable acupuncture needles to insert into the Jianqian, Jianyu (LI15), Jianliao (SJ5), Jianzheng (SJ9) and Ashi-point respectively with the right hand, waited for  qi -arriving, twirled the needles forward about 3 to 6 times. When a tightened feeling was achieved beneath the needle tip, the doctor held the needle body to slightly shake it 3 to 6 times which mimicked a fish to swallow a hook, kept the situation for a while till relaxation, followed by retaining the needle for 30 min and then withdrew it slowly. Afterwards, the doctor performed Tuina manipulation at the upper limbs for 20 to 30 min. For patients of the conventional needling group, the same acupoints were needled and stimulated with the uniform reducing and reinforcing method for 1 min, followed by retaining the needles for 30 min. Then, massage was performed for 20 to 30 min in the same way as those in the MHF group. The treatment was conducted once daily, 6 times a week for 2 weeks. After the treatment, the visual analogue scale (VAS) was used to assess the pain degree, the range of motion (ROM) scale of the shoulder joint adopted to assess the function, and the activity of daily living (ADL) scale used to assess the patients' daily living ability. The therapeutic effects of the two groups were evaluated after the treatment.
RESULTS


After the treatment, the VAS scores of the two groups were notably decreased ( P <0.05), being significantly lower in the GHF group than in the conventional needling group ( P <0.05). The ROM score and ADL score of the two groups were obviously increased ( P <0.05), being significantly higher in the MHF group than in the conventional needling group ( P <0.05). Of the 36 cases in the conventional needling and MHF groups, 7 and 17 were cured, 11 and 12 experienced remarkable improvement, 13 and 4 were improved, and 5 and 3 were ineffective, with the total effective rate being 86.1% （31/36） and 91.7% (33/36), respectively. The total effective rate of MHF group was evidently higher than that of the conventional needling group ( P <0.05).
CONCLUSION


Both MHF and conventional needling is effective in relieving scapulohumeral periarthritis, and the effect of MHF is ob-viously superior to that of conventional needling in relieving pain state and improving function of the affected shoulder joint.",2020,"The ROM score and ADL score of the two groups were obviously increased ( P <0.05), being significantly higher in the MHF group than in the conventional needling group ( P <0.05).",['72 patients with scapulohumeral periarthritis'],"['scapulohumeral periarthritis by ""metal hook fishing""-like needling technique combined with Tuina manipulation', 'metal hook fishing"" (MHF)-like needling technique combined with Tuina manipulation', 'MHF-like needling (MHF) and conventional needling groups', 'MHF', 'MHF and conventional needling', 'GHF']","['visual analogue scale (VAS', 'VAS scores', 'therapeutic effects', 'total effective rate', 'pain degree, the range of motion (ROM) scale of the shoulder joint adopted to assess the function, and the activity of daily living (ADL) scale', 'ROM score and ADL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031037', 'cui_str': 'Periarthritis'}]","[{'cui': 'C0031037', 'cui_str': 'Periarthritis'}, {'cui': 'C0441178', 'cui_str': 'Metal hook'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",72.0,0.0157689,"The ROM score and ADL score of the two groups were obviously increased ( P <0.05), being significantly higher in the MHF group than in the conventional needling group ( P <0.05).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen 518001, Guangdong Province, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Yang', 'Affiliation': 'Department of Continuing Education and Training of Higher Education Press Limited Company, Beijing 100029.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190432']
1794,32869580,[Clinical efficacy and safety of acupuncture combined with western medicine in treatment of children with abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome].,"OBJECTIVE


To investigate the clinical effect of acupuncture combined with western medicine in the treatment of children with abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome.
METHODS


A total of 60 children with abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome were randomly divided into treatment group and control group, with 30 patients in each group. The patients in the control group were given Hydroprednisone 2 mg•kg -1 •d -1 , and in addition to the treatment in the control group, those in the treatment group were given acupuncture at Tianshu (ST25), Neiguan (PC6), Zusanli (ST36), Zhongwan (CV12), Qihai (CV6), and Sanyinjiao (SP6) once a day, with a needle retaining time of 15 minutes. Both groups were treated for 7 days. The scores of abdominal pain, hematochezia, hematemesis, vomiting, poor appetite, abdominal distension, purpura, occult blood in stool, and abdominal ultrasound were determined before and after treatment, and the time to the disappearance of abdominal pain was observed. Clinical outcome was evaluated.
RESULTS


The treatment group had a significantly higher effective rate than the control group ［96.7% (29/30) vs 80.0% (24/30),  P <0.05］. Both groups had significant reductions in the scores of abdominal pain, hematochezia, hematemesis, poor appetite, abdominal distension, purpura, occult blood and abdominal ultrasound and the total score after treatment ( P <0.05), and compared with the control group after treatment, the treatment group had significantly lower scores of abdominal pain, poor appetite, abdominal distension, and abdominal ultrasound and total score ( P <0.05). The treatment group had a significantly shorter time to disappea-rance of abdominal pain than the control group ( P <0.05).
CONCLUSION


Acupuncture combined with western medicine has a better clinical effect than western medicine alone in the treatment of abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome and can significantly improve clinical symptoms and signs and shorten the time to disappearance of abdominal pain.",2020,"Both groups had significant reductions in the scores of abdominal pain, hematochezia, hematemesis, poor appetite, abdominal distension, purpura, occult blood and abdominal ultrasound and the total score after treatment ( P <0.05), and compared with the control group after treatment, the treatment group had significantly lower scores of abdominal pain, poor appetite, abdominal distension, and abdominal ultrasound and total score ( P <0.05).","['60 children with abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome', 'children with abdominal Henoch-Schonlein purpura with spleen-stomach damp-heat syndrome']","['acupuncture at Tianshu (ST25), Neiguan (PC6), Zusanli (ST36), Zhongwan (CV12), Qihai (CV6), and Sanyinjiao (SP6', 'Acupuncture combined with western medicine', 'acupuncture combined with western medicine']","['scores of abdominal pain, hematochezia, hematemesis, vomiting, poor appetite, abdominal distension, purpura, occult blood in stool, and abdominal ultrasound', 'scores of abdominal pain, hematochezia, hematemesis, poor appetite, abdominal distension, purpura, occult blood and abdominal ultrasound and the total score', 'shorter time to disappea-rance of abdominal pain', 'abdominal pain, poor appetite, abdominal distension, and abdominal ultrasound and total score', 'time to the disappearance of abdominal pain', 'effective rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0034152', 'cui_str': 'Henoch-Schönlein purpura'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450548', 'cui_str': 'SP6'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0018926', 'cui_str': 'Hematemesis'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0034150', 'cui_str': 'Purpura'}, {'cui': 'C0266813', 'cui_str': 'Occult blood in stools'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0266292,"Both groups had significant reductions in the scores of abdominal pain, hematochezia, hematemesis, poor appetite, abdominal distension, purpura, occult blood and abdominal ultrasound and the total score after treatment ( P <0.05), and compared with the control group after treatment, the treatment group had significantly lower scores of abdominal pain, poor appetite, abdominal distension, and abdominal ultrasound and total score ( P <0.05).","[{'ForeName': 'Sheng-Jie', 'Initials': 'SJ', 'LastName': 'You', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Ying-Xue', 'Initials': 'YX', 'LastName': 'Sun', 'Affiliation': 'Department of Traditional Chinese Medicine, Tangshan Maternal and Child Health Hospital, Tangshan 063000, Hebei Province.'}, {'ForeName': 'Fei-Yu', 'Initials': 'FY', 'LastName': 'Guo', 'Affiliation': 'Center for Preventive Treatment, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 101000.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Li', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Song-Yu', 'Initials': 'SY', 'LastName': 'He', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Xin-Tai', 'Initials': 'XT', 'LastName': 'Wang', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190649']
1795,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
1796,32880343,"Comparison of praziquantel efficacy at 40 mg/kg and 60 mg/kg in treating Schistosoma haematobium infection among schoolchildren in the Ingwavuma area, KwaZulu-Natal, South Africa.","BACKGROUND


The World Health Organization recommends praziquantel (PZQ) (40 mg/kg body weight) for treating schistosomiasis. However, drug failure has been reported, prompting use of 60 mg/kg, for which results have been inconsistent.
OBJECTIVES


To compare the efficacy of PZQ 40 mg/kg and 60 mg/kg in treating schoolchildren infected with Schistosoma haematobium.
METHODS


The study was conducted during November 2017 - August 2018 in the Ingwavuma area, uMkhanyakude District, KwaZulu-Natal Province, South Africa. Children aged 10 - 15 years were screened for S. haematobium using a filtration technique. Infected children were randomly assigned to a dose of PZQ of 40 mg/kg or 60 mg/kg. Side-effects were recorded within 24 hours after treatment using questionnaires and direct observation. Four weeks after treatment, participants were retested for S. haematobium infection. Baseline and post-treatment mean egg counts were calculated. Cure rate (CR) and egg reduction rate (ERR) were used to determine PZQ efficacy, while repeated-measures analysis of variance determined the effect of both doses on infection intensity. A χ2 test was used to determine the association of side-effects with treatment, with a p-value ≤0.05.
RESULTS


Forty-three and 36 children were treated with PZQ 40 mg/kg and 60 mg/kg, respectively. The 40 mg/kg group had a CR of 79.0% and an ERR of 97.2%, and the 60 mg/kg group a CR of 83.0% and an ERR of 98.3%. The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05). Abdominal pains, dizziness and fatigue were common among children who received PZQ 40 mg/kg, while headache, dizziness and nausea were common in the 60 mg/kg group.
CONCLUSIONS


The efficacy of PZQ at 60 mg/kg was similar to that at 40 mg/kg. A dose &gt;40 mg/kg therefore does not add value in treating S. haematobium infection. Transient side-effects (mostly dizziness) were observed more in the 60 mg/kg group than in the 40 mg/kg group. We recommend continued use of 40 mg/kg body weight for treating schistosomiasis.",2020,The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05).,"['Infected children', 'Children aged 10 - 15 years', 'schoolchildren in the Ingwavuma area, KwaZulu-Natal, South Africa', 'Forty-three and 36 children', 'November 2017 - August 2018 in the Ingwavuma area, uMkhanyakude District, KwaZulu-Natal Province, South Africa', 'schoolchildren infected with Schistosoma haematobium']","['PZQ', 'praziquantel (PZQ']","['Abdominal pains, dizziness and fatigue', 'headache, dizziness and nausea', 'Transient side-effects (mostly dizziness', 'Cure rate (CR) and egg reduction rate (ERR', 'infection intensity', 'Side-effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0036316', 'cui_str': 'Schistosoma haematobium'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.226608,The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kabuyaya', 'Affiliation': 'Discipline of Public Health Medicine, School of Nursing and Public Health, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. muhubirikabuyaya@gmail.com.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Chimbari', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukaratirwa', 'Affiliation': ''}]",South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde,['10.7196/SAMJ.2020.v110i7.13926']
1797,32877302,"Re: The Effect of Antioxidants on Male Factor Infertility: The Males, Antioxidants, and Infertility (MOXI) Randomized Clinical Trial.",,2020,,['Male Factor Infertility'],['Antioxidants'],"['Males, Antioxidants, and Infertility (MOXI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]",,0.275223,,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Niederberger', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001253.01']
1798,32876694,Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis.,"Importance


Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support.
Objective


To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality.
Design, Setting, and Participants


Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios.
Exposures


Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients).
Main Outcomes and Measures


The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events.
Results


A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as ""low"" for 6 of the 7 mortality results and as ""some concerns"" in 1 trial because of the randomization method. Five trials reported mortality at 28 days, 1 trial at 21 days, and 1 trial at 30 days. There were 222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to usual care or placebo (summary OR, 0.66 [95% CI, 0.53-0.82]; P < .001 based on a fixed-effect meta-analysis). There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis. The fixed-effect summary OR for the association with mortality was 0.64 (95% CI, 0.50-0.82; P < .001) for dexamethasone compared with usual care or placebo (3 trials, 1282 patients, and 527 deaths), the OR was 0.69 (95% CI, 0.43-1.12; P = .13) for hydrocortisone (3 trials, 374 patients, and 94 deaths), and the OR was 0.91 (95% CI, 0.29-2.87; P = .87) for methylprednisolone (1 trial, 47 patients, and 26 deaths). Among the 6 trials that reported serious adverse events, 64 events occurred among 354 patients randomized to corticosteroids and 80 events occurred among 342 patients randomized to usual care or placebo.
Conclusions and Relevance


In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.",2020,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","['patients with coronavirus disease 2019 (COVID-19', 'hospitalized patients with COVID-19 who required respiratory support', '12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020', '1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis', 'critically ill patients with COVID-19, administration of systemic corticosteroids, compared with', '222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to', 'Critically Ill Patients With COVID-19', '1703 critically ill patients with COVID-19', '1025 patients']","['corticosteroids', 'systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo', 'methylprednisolone', 'usual care or placebo', 'dexamethasone', 'placebo', 'hydrocortisone']","['cause mortality', 'investigator-defined serious adverse events', 'mortality quantified using odds ratios (ORs', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3844105', 'cui_str': '425'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",1703.0,0.618646,"There was little inconsistency between the trial results (I2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Janet V', 'Initials': 'JV', 'LastName': 'Diaz', 'Affiliation': 'Clinical Unit, Health Emergencies Programme, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Research Unit, Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Academic Research Organization, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Insitute, São Paulo, Brazil.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Médecine Intensive-Réanimation, INSERM CIC1415, CHRU de Tours, Tours, France.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, Faculty of Population Health Sciences, University College London, London, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, England.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Heming', 'Affiliation': 'Department of Intensive Care, Raymond Poincaré Hospital (APHP), School of Medicine Simone Veil, University Paris Saclay-UVSQ, Paris, France.'}, {'ForeName': 'Julian P T', 'Initials': 'JPT', 'LastName': 'Higgins', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Le Gouge', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Leclerc', 'Affiliation': 'CIC INSERM 1415-CHRU de Tours, Tours, France.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine Department, Nottingham University Hospitals NHS Trust, Nottingham, England.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Anesthesiology, Pain, and Intensive Care Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, Service de Médecine Intensive Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Savovic', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tomazini', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.17023']
1799,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
1800,32873466,Effectiveness of knotless suture as a wound closure agent for impacted third molar - A split mouth randomized controlled clinical trial.,"AIM AND OBJECTIVE


This study was aimed to compare the effectiveness of 3-0 knotless barbed suture (polydioxanone) with 4-0 polyglactin 910 (vicryl) in achieving wound closure after impacted mandibular third molar surgery.
MATERIALS AND METHODS


Patients with bilateral mandibular third molar impaction of similar difficulty index enrolled in the split mouth study. Wound closure was done using 3-0 knotless suture (30 × 30 cm) for the study group and 4-0 polyglactin 910 (vicryl) for the control group following extraction. Samples were allocated on the basis of simple randomization. The clinical outcome parameters that were measured were (1) time taken to achieve wound closure and hemostasis (2) postoperative mouth opening (3) swelling and (4) Pain. Data analysis involved descriptive statistics and paired t-tests (p < 0.05). IBM SPSS software (v.20.0) was used.
RESULT


A total of 25 patients participated in the study (14 males and 11 females) with the mean age of 25.6 years. The mean time taken for wound approximation was 2.45 min and 4.1480 min (p-0.026) for the study and control groups respectively. The difference in mouth opening (p-0.015), VAS score(p-0.24), and swelling (p-0.041) were statistically significant on the first post-operative day in the study group than the control group indicating reduction in pain (p < 0.0001), swelling (p-0.033) and improvement in mouth opening (p < 0.0001) on seventh post-operative day in the study group compared to the control group.
CONCLUSION


Knotless suture is an effective alternative to conventional sutures for intra oral wound closure as it reduces suturing time, facilitates effective wound closure and minimises knot related complications.",2020,"The difference in mouth opening (p-0.015), VAS score(p-0.24), and swelling (p-0.041) were statistically significant on the first post-operative day in the study group than the control group indicating reduction in pain (p < 0.0001), swelling (p-0.033) and improvement in mouth opening (p < 0.0001) on seventh post-operative day in the study group compared to the control group.
","['Patients with bilateral mandibular third molar impaction of similar difficulty index enrolled in the split mouth study', '25 patients participated in the study (14 males and 11 females) with the mean age of 25.6 years']","['knotless suture', '3-0 knotless barbed suture (polydioxanone) with 4-0 polyglactin 910 (vicryl']","['mouth opening (p-0.015), VAS score(p-0.24), and swelling', 'mean time taken for wound approximation', 'swelling (p-0.033) and improvement in mouth opening', '1) time taken to achieve wound closure and hemostasis (2) postoperative mouth opening (3) swelling and (4) Pain', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}]","[{'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C4517396', 'cui_str': '0.015'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4517441', 'cui_str': '0.24'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25.0,0.139332,"The difference in mouth opening (p-0.015), VAS score(p-0.24), and swelling (p-0.041) were statistically significant on the first post-operative day in the study group than the control group indicating reduction in pain (p < 0.0001), swelling (p-0.033) and improvement in mouth opening (p < 0.0001) on seventh post-operative day in the study group compared to the control group.
","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Ramkumar Ceyar', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: drrkceyar@gmail.com.'}, {'ForeName': 'Guru Prasad', 'Initials': 'GP', 'LastName': 'Thulasidoss', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: drguru84@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raja Sethupathy Cheeman', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: zeusians.noss@gmail.com.'}, {'ForeName': 'Sembiyan', 'Initials': 'S', 'LastName': 'Sagadevan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: sembi2494@gmail.com.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089, India. Electronic address: kksukanya@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.07.014']
1801,32871021,Complementary and alternative therapies for post-caesarean pain.,"BACKGROUND


Pain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain.
OBJECTIVES


To assess the effects of CAM for post-caesarean pain.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles.
SELECTION CRITERIA


Randomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain.
DATA COLLECTION AND ANALYSIS


Two review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE.
MAIN RESULTS


We included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge. Primary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect Acupuncture or acupressure We are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low. Aromatherapy Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia. Electromagnetic therapy Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence). Massage We identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty. Music Music plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I 2  = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low. Reiki We are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence). Transcutaneous electrical nerve stimulation TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). We are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).
AUTHORS' CONCLUSIONS


Some CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.",2020,"Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).","['37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief', 'post-caesarean pain']","['Complementary alternative therapies (CAM', 'CAM', 'placebo plus analgesia', 'acupuncture or acupressure plus analgesia (versus placebo plus analgesia', 'TENS plus analgesia (versus placebo plus analgesia', 'massage (foot and hand) plus analgesia versus analgesia', 'acupressure', 'acupuncture or acupressure', 'acupuncture or acupressure plus analgesia', 'Transcutaneous electrical nerve stimulation TENS', 'Aromatherapy Aromatherapy plus analgesia', 'Electromagnetic therapy Electromagnetic therapy', 'placebo', 'Acupuncture or acupressure plus analgesia (versus analgesia', 'Relaxation Relaxation']","['respiratory rate', 'vital signs, rescue analgesic requirement', 'pain and adverse effects', 'adverse effects (anxiety', 'pain relief', 'pain, adverse effects (anxiety), vital signs and rescue analgesic requirement', 'heart rate', 'post-CS pain', 'pain']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C2729328', 'cui_str': 'Electromagnetic therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",90.0,0.675575,"Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).","[{'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Zimpel', 'Affiliation': 'Alagoas State University of Health Sciences, Maceió, Brazil.'}, {'ForeName': 'Maria Regina', 'Initials': 'MR', 'LastName': 'Torloni', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Jm', 'Initials': 'GJ', 'LastName': 'Porfírio', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil.'}, {'ForeName': 'Ronald Lg', 'Initials': 'RL', 'LastName': 'Flumignan', 'Affiliation': 'Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edina Mk', 'Initials': 'EM', 'LastName': 'da Silva', 'Affiliation': 'Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011216.pub2']
1802,32871329,Rationale and design of the MULTISTARS AMI Trial: A randomized comparison of immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease.,"About half of patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD). Recent evidence supports complete revascularization in these patients. However, optimal timing of non-culprit lesion revascularization in STEMI patients is unknown because dedicated randomized trials on this topic are lacking. STUDY DESIGN: The MULTISTARS AMI trial is a prospective, international, multicenter, randomized, two-arm, open-label study planning to enroll at least 840 patients. It is designed to investigate whether immediate complete revascularization is non-inferior to staged (within 19-45 days) complete revascularization in patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI). After successful primary PCI of the culprit artery, patients are randomized in a 1:1 ratio to immediate or staged complete revascularization. The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year. CONCLUSIONS: The MULTISTARS AMI trial tests the hypothesis that immediate complete revascularization is non-inferior to staged complete revascularization in stable patients with STEMI and MVD.",2020,"The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year.","['patients with ST-segment elevation myocardial infarction and multivessel disease', 'patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI', 'enroll at least 840 patients', 'patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD']",['immediate versus staged complete revascularization'],"['composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.110186,"The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year.","[{'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Infermi Hospital, Rivoli, Turin, Italy.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Schwarz', 'Affiliation': 'Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital for the Universities of Kiel, Lübeck and Hamburg, Bad Segeberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Stephan B', 'Initials': 'SB', 'LastName': 'Felix', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, and DZHK (German Centre for Cardiovascular Research), Partner Site Greifswald, Germany.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Department of Internal Medicine II, Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Aurel', 'Initials': 'A', 'LastName': 'Toma', 'Affiliation': 'Department of Internal Medicine II, Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moccetti', 'Affiliation': 'Fondazione Cardiocentro Ticino, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vercellino', 'Affiliation': 'Department of Internal Medicine, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Angelos G', 'Initials': 'AG', 'LastName': 'Rigopoulos', 'Affiliation': 'Mid-German Heart Center, Department of Internal Medicine III (KIM-III), Division of Cardiology, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle, Halle, Germany.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Rohla', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schindler', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wischnewsky', 'Affiliation': 'FB Mathematics and Computer Science, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Technische Universität Dresden, Department of Internal Medicine and Cardiology, Herzzentrum Dresden, University Clinic, Dresden, Germany.'}, {'ForeName': 'P Christian', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'Department of Internal Medicine I, Division of Cardiology, Pneumology, Angiology and Intensive Medical Care, University Hospital Jena, Friedrich-Schiller-University Jena, Jena, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital for the Universities of Kiel, Lübeck and Hamburg, Bad Segeberg, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Weidinger', 'Affiliation': '2(nd) Medical Department with Cardiology and Intensive Care Medicine, Rudolfstiftung Hospital, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'Internal Medicine II, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität, Munich, and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland. Electronic address: willibald.maier@uzh.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.07.016']
1803,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1804,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
1805,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
1806,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
1807,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
1808,32883807,Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial.,"OBJECTIVES


To determine impact of a primary care-based child obesity prevention intervention beginning during pregnancy on early childhood weight outcomes in low-income Hispanic families.
METHODS


A randomized controlled trial comparing mother-infant pairs receiving either standard care or the Starting Early Program providing prenatal and postpartum nutrition counseling and nutrition parenting support groups targeting key obesity-related feeding practices in low-income groups. Primary outcomes were reduction in weight-for-age  z -scores (WFAzs) from clinical anthropometric measures, obesity prevalence (weight for age ≥95th percentile), and excess weight gain (WFAz trajectory) from birth to age 3 years. Secondary outcomes included dose effects.
RESULTS


Pregnant women ( n  = 566) were enrolled in the third trimester; 533 randomized to intervention ( n  = 266) or control ( n  = 267). Also, 358 children had their weight measured at age 2 years; 285 children had weight measured at age 3 years. Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76). No group differences in obesity prevalence were found. When generalized estimating equations were used, significant average treatment effects were detected between 10-26 months (B = -0.19,  P  = .047), although not through age 3 years. In within group dose analyses at 3 years, obesity rates (26.4%, 22.5%, 8.0%,  P  = .02) decreased as attendance increased with low, medium, and high attendance.
CONCLUSIONS


Mean WFAz and growth trajectories were lower for the intervention group through age 2 years, but there were no group differences at age 3. Further study is needed to enhance sustainability of effects beyond age 2.",2020,"Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76).","['358 children had their weight measured at age 2 years; 285 children had weight measured at age 3 years', 'Pregnant women ( n  = 566) were enrolled in the third trimester; 533 randomized to intervention ( n  = 266) or control ( n  = 267', 'low-income Hispanic families', 'mother-infant pairs receiving either']","['primary care-based child obesity prevention intervention', 'standard care or the Starting Early Program providing prenatal and postpartum nutrition counseling and nutrition parenting support groups targeting key obesity-related feeding practices in low-income groups', 'Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program']","['lower mean WFAz', 'attendance increased with low, medium, and high attendance', 'Mean WFAz and growth trajectories', 'dose effects', 'obesity prevalence', 'reduction in weight-for-age  z -scores (WFAzs) from clinical anthropometric measures, obesity prevalence (weight for age ≥95th percentile), and excess weight gain (WFAz trajectory', 'obesity rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",566.0,0.0827146,"Intervention infants had lower mean WFAz at 18 months (0.49 vs 0.73,  P  = .04) and 2 years (0.56 vs 0.81,  P  = .03) but not at 3 years (0.63 vs 0.59,  P  = .76).","[{'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Divisions of General Pediatrics and mary.messito@nyumc.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Developmental and Behavioral Pediatrics, Department of Pediatrics, NYU Grossman School of Medicine and.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Scott', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York; and.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Divisions of General Pediatrics and.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Divisions of General Pediatrics and.'}]",Pediatrics,['10.1542/peds.2020-0709']
1809,32885274,An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure.,"PURPOSE


Glasdegib, an oral inhibitor of the Hedgehog signaling pathway, is approved in the United States in combination with low-dose cytarabine (LDAC) to treat patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive chemotherapy. This population pharmacokinetic/pharmacodynamic analysis characterized the time course of survival with glasdegib + LDAC relative to LDAC alone, and explored whether the differences in glasdegib exposure at the clinical dose of 100 mg once daily (QD) significantly affected overall survival (OS).
METHODS


Data from the BRIGHT AML 1003 trial in patients with AML were included in treatment-response (glasdegib + LDAC, n = 78; LDAC alone, n = 38) and exposure-response (glasdegib + LDAC, n = 75) analyses.
RESULTS


The analyses demonstrate that patients treated with glasdegib + LDAC (vs LDAC alone) at any time point during the study period were 58% less likely to die, translating to prolonging of median OS by ~ 5 months (hazard ratio 0.42 [95% confidence interval 0.28-0.66]). Variability in glasdegib exposures did not impact the risk of death. Additionally, potential covariates such as patient demographics, prior treatment with a hypomethylating agent, baseline safety laboratory values, and disease characteristics, did not impact the probability of OS.
CONCLUSION


Together these results confirm that glasdegib + LDAC treatment (vs. LDAC alone) is associated with a significant survival benefit in patients with newly diagnosed AML, and that variability in glasdegib doses (e.g., for dose reductions) and exposures do not compromise the survival benefit of glasdegib 100 mg QD.
CLINICAL TRIAL NUMBER


NCT01546038.",2020,Variability in glasdegib exposures did not impact the risk of death.,"['patients with newly diagnosed AML', 'patients with AML were included in treatment-response (glasdegib\u2009+\u2009LDAC, n\u2009=\u200978', 'patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure', 'patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive']","['glasdegib\u2009+\u2009LDAC', 'LDAC alone, n\u2009=\u200938) and exposure-response (glasdegib\u2009+\u2009LDAC, n\u2009=\u200975) analyses', 'intensive chemotherapy', 'cytarabine (LDAC']","['overall survival (OS', 'prolonging of median OS', 'risk of death', 'survival benefit', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.422954,Variability in glasdegib exposures did not impact the risk of death.,"[{'ForeName': 'Swan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA. swan.lin@pfizer.com.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shaik', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Oncology, Global Product Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta, GA, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04132-x']
1810,32871100,"Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Cardiac muscle hypercontractility is a key pathophysiological abnormality in hypertrophic cardiomyopathy, and a major determinant of dynamic left ventricular outflow tract (LVOT) obstruction. Available pharmacological options for hypertrophic cardiomyopathy are inadequate or poorly tolerated and are not disease-specific. We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy.
METHODS


In this phase 3, randomised, double-blind, placebo-controlled trial (EXPLORER-HCM) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or placebo for 30 weeks. Visits for assessment of patient status occurred every 2-4 weeks. Serial evaluations included echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration. The primary endpoint was a 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO 2  increase without NYHA class worsening. Secondary endpoints assessed changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB). This study is registered with ClinicalTrials.gov, NCT03470545.
FINDINGS


Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned to mavacamten (n=123 [49%]) or placebo (n=128 [51%]). 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19·4%, 95% CI 8·7 to 30·1; p=0·0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1; p<0·0001), greater increase in pVO 2  (+1·4 mL/kg per min, 0·6 to 2·1; p=0·0006), and improved symptom scores (KCCQ-CSS +9·1, 5·5 to 12·7; HCMSQ-SoB -1·8, -2·4 to -1·2; p<0·0001). 34% more patients in the mavacamten group improved by at least one NYHA class (80 of 123 patients in the mavacamten group vs 40 of 128 patients in the placebo group; 95% CI 22·2 to 45·4; p<0·0001). Safety and tolerability were similar to placebo. Treatment-emergent adverse events were generally mild. One patient died by sudden death in the placebo group.
INTERPRETATION


Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with obstructive hypertrophic cardiomyopathy. The results of this pivotal trial highlight the benefits of disease-specific treatment for this condition.
FUNDING


MyoKardia.",2020,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","['68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms', 'patients with obstructive hypertrophic cardiomyopathy', 'Between May 30, 2018, and July 12, 2019', '429 adults were assessed for eligibility, of whom 251 (59', 'symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM']","['placebo', 'placebo-controlled trial (EXPLORER-HCM', 'mavacamten', 'Mavacamten']","['Safety and tolerability', 'echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration', 'symptom scores', 'exercise capacity, LVOT obstruction, NYHA functional class, and health status', 'changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB', 'sudden death', '1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0344917', 'cui_str': 'Left ventricular outflow tract obstruction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",429.0,0.654238,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","[{'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Cardiomyopathy Unit, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; University of Florence, Florence, Italy. Electronic address: iacopo.olivotto@unifi.it.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Oreziak', 'Affiliation': '1st Department of Arrhythmia, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barriales-Villa', 'Affiliation': 'Unidad de Cardiopatías Familiares, Instituto de Investigación Biomédica de A Coruña, A Coruña, Spain; Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain; Servizo Galego de Saúde, A Coruña, Spain; Universidade da Coruña, A Coruña, Spain; Centro de Investigación Biomédica en Red, Madrid, Spain.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Masri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Garcia-Pavia', 'Affiliation': 'Centro de Investigación Biomédica en Red, Madrid, Spain; Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain; Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Kubanek', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Morten K', 'Initials': 'MK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gimeno-Blanes', 'Affiliation': 'Inherited Cardiac Disease Unit, University Hospital Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Afshar', 'Affiliation': 'Intermountain Medical Center Heart Institute, Intermountain Medical Center, Murray, UT, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Division of Cardiology, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA; Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Hegde', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Mondira', 'Initials': 'M', 'LastName': 'Bhattacharya', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia Burstein', 'Initials': 'CB', 'LastName': 'Waldman', 'Affiliation': 'HCMBeat, Los Angeles, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31792-X']
1811,32871327,"Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial.","BACKGROUND


The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown.
METHODS AND DESIGN


The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
RESULTS


Up to the end of July 2020, approximately 1,200 ""real-world"" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023.
CONCLUSION


This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.",2020,"The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
","['patients undergoing PCI in the daily clinical practice', 'patients with diverse clinical and anatomical features', 'patients with stable angina or acute coronary syndromes undergoing PCI in Korea', 'A total of 2,000 patients']","['OCT-guided PCI strategy or an IVUS-guided PCI strategy', '2 imaging-guided strategies', 'OCT-guided versus IVUS-guided PCI strategies', 'IVUS-guided versus OCT-guided PCI', 'Intravascular ultrasound (IVUS) and optical coherence tomography (OCT', 'optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention']","['target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.142284,"The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
","[{'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Yun-Kyeong', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Cheol Hyun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Young Won', 'Initials': 'YW', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Kyunghee University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Cardiology, Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Jun-Hyok', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Cardiology, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: sjpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.08.003']
1812,32881359,Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID-19: An Open-Label Randomized Controlled Pilot Study.,"This open-label randomized controlled pilot study aimed to test the study feasibility of bromhexine hydrochloride (BRH) tablets for the treatment of mild or moderate coronavirus disease 2019 (COVID-19) and to explore its clinical efficacy and safety. Patients with mild or moderate COVID-19 were randomly divided into the BRH group or the control group at a 2:1 ratio. Routine treatment according to China's Novel Coronavirus Pneumonia Diagnosis and Treatment Plan was performed in both groups, whereas patients in the BRH group were additionally given oral BRH (32 mg t.i.d.) for 14 consecutive days. The efficacy and safety of BRH were evaluated. A total of 18 patients with moderate COVID-19 were randomized into the BRH group (n = 12) or the control group (n = 6). There were suggestions of BRH advantage over placebo in improved chest computed tomography, need for oxygen therapy, and discharge rate within 20 days. However, none of these findings were statistically significant. BRH tablets may potentially have a beneficial effect in patients with COVID-19, especially for those with lung or hepatic injury. A further definitive large-scale clinical trial is feasible and necessary.",2020,"A total of 18 patients with moderate COVID-19 were randomized into the BRH group (n = 12) or the Control group (n = 6).There were suggestions of BRH advantage over placebo in improved chest computed tomography (CT), need for oxygen therapy, and discharge rate within 20 days.","['18 patients with moderate COVID-19', 'Patients with mild or moderate COVID-19', 'mild or moderate coronavirus disease 2019 (COVID-19', 'Moderate COVID-19']","['Bromhexine Hydrochloride Tablets', 'BRH', 'oral BRH', 'BRH advantage over placebo', 'bromhexine hydrochloride (BRH) tablets']",['efficacy and safety of BRH'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0005647', 'cui_str': 'Bromhexine hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005647', 'cui_str': 'Bromhexine hydrochloride'}]",18.0,0.0275337,"A total of 18 patients with moderate COVID-19 were randomized into the BRH group (n = 12) or the Control group (n = 6).There were suggestions of BRH advantage over placebo in improved chest computed tomography (CT), need for oxygen therapy, and discharge rate within 20 days.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesia and Critical Care, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Laifang', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Emergency, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Critical Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chanfan', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Clinical Research Unit, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""Clinical Research Unit, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Mingjing', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Clinical Research Unit, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Clinical Research Unit, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Zhijuan', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Shihui', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': ""Department of Pharmacy, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Gastrointestinal Surgery, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}]",Clinical and translational science,['10.1111/cts.12881']
1813,32877886,Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.,"Background OBJECTIVE: To investigate the effects of peripheral muscle training (PMT) and different inspiratory muscle training (IMT) methods on respiratory functions, exercise capacity, and biochemistry parameters in coronary artery disease patients with metabolic syndrome.
METHODS


This prospective, single-blind, randomized-controlled study included 60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA] Class I-II, left ventricular ejection fraction >40%). Patients were randomly divided into three groups: neuromuscular electrical stimulation (NMES) plus PMT group (NMES + PMT group, n = 20), IMT plus PMT group (IMT + PMT group, n = 20) and PMT group (PMT group, n = 20). Treatment continued for six weeks for all groups. The NMES was applied to rectus abdominis, IMT was applied with 30% of maximal inspiratory pressures, and PMT was applied at home. Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters were measured before and after training.
RESULTS


There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05). Significant improvements in C-reactive protein and erythrocyte sedimentation rate were observed in NMES + PMT and IMT + PMT groups (p < 0.05). Among the groups, there was a significant difference in maximal inspiratory pressure (p = 0.02) and erythrocyte sedimentation rate (p = 0.037) in favor of NMES + PMT group (p < 0.05).
CONCLUSION


Our study results showed significant improvements in respiratory functions, exercise capacity, and biochemistry markers in all groups. Different IMT methods can be used in cardiopulmonary rehabilitation to improve exercise intolerance in coronary artery disease patients with metabolic syndrome.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03523026.",2020,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","['coronary artery disease patients with metabolic syndrome', '60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA']","['peripheral muscle training (PMT) and different inspiratory muscle training (IMT', 'peripheral and different inspiratory muscle training methods', 'neuromuscular electrical stimulation (NMES) plus PMT group (NMES\xa0+\xa0PMT group, n\xa0=\xa020), IMT plus PMT group (IMT\xa0+\xa0PMT group, n\xa0=\xa020) and PMT group (PMT', 'NMES']","['Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters', 'exercise intolerance', 'maximal inspiratory pressure', 'respiratory functions, exercise capacity, and biochemistry markers', 'erythrocyte sedimentation rate', 'C-reactive protein and erythrocyte sedimentation rate', 'spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O', 'respiratory functions, exercise capacity, and biochemistry parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]",60.0,0.028139,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","[{'ForeName': 'Kıymet', 'Initials': 'K', 'LastName': 'Muammer', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Medipol University, Istanbul, Turkey. Electronic address: fmutluay@medipol.edu.tr.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Alev Arat', 'Initials': 'AA', 'LastName': 'Özkan', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106119']
1814,32885188,Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial.,"Background


Despite extensive efforts to develop and refine intervention packages, complex interventions often fail to produce the desired health impacts in full-scale evaluations. A recent example of this phenomenon is BetterBirth, a complex intervention designed to implement the World Health Organization's Safe Childbirth Checklist and improve maternal and neonatal health. Using data from the BetterBirth Program and its associated trial as a case study, we identified lessons to assist in the development and evaluation of future complex interventions.
Methods


BetterBirth was refined across three sequential development phases prior to being tested in a matched-pair, cluster randomized trial in Uttar Pradesh, India. We reviewed published and internal materials from all three development phases to identify barriers hindering the identification of an optimal intervention package and identified corresponding lessons learned. For each lesson, we describe its importance and provide an example motivated by the BetterBirth Program's development to illustrate how it could be applied to future studies.
Results


We identified three lessons: (1) develop a robust theory of change (TOC); (2) define optimization outcomes, which are used to assess the effectiveness of the intervention across development phases, and corresponding criteria for success, which determine whether the intervention has been sufficiently optimized to warrant full-scale evaluation; and (3) create and capture variation in the implementation intensity of components. When applying these lessons to the BetterBirth intervention, we demonstrate how a TOC could have promoted more complete data collection. We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial. Finally, we show how variation in components' implementation intensities could have been used to identify effective intervention components.
Conclusion


These lessons learned can be applied during both early and advanced stages of complex intervention development and evaluation. By using examples from a real-world study to demonstrate the relevance of these lessons and illustrating how they can be applied in practice, we hope to encourage future researchers to collect and analyze data in a way that promotes more effective complex intervention development and evaluation.
Trial registration


ClinicalTrials.gov, NCT02148952; registered on May 29, 2014.",2020,We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial.,[],[],[],[],[],[],,0.0405374,We propose an optimization outcome and related criteria for success and illustrate how they could have resulted in additional development phases prior to the full-scale trial.,"[{'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Barnhart', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA USA.'}, {'ForeName': 'Katherine E A', 'Initials': 'KEA', 'LastName': 'Semrau', 'Affiliation': 'Ariadne Labs, Boston, MA USA.'}, {'ForeName': 'Corwin M', 'Initials': 'CM', 'LastName': 'Zigler', 'Affiliation': 'University of Texas, Austin, TX USA.'}, {'ForeName': 'Rose L', 'Initials': 'RL', 'LastName': 'Molina', 'Affiliation': 'Ariadne Labs, Boston, MA USA.'}, {'ForeName': 'Megan Marx', 'Initials': 'MM', 'LastName': 'Delaney', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA USA.'}]",Implementation science communications,['10.1186/s43058-020-00014-8']
1815,32876119,Clinical and radiographic evaluation of a new stain-free tricalcium silicate cement in pulpotomies.,"The aim of this study was to evaluate and compare the clinical and radiographic success rates of pulpotomies in primary molars using a new stain-free tricalcium silicate cement (Bio-C Pulpo) versus a conventional white MTA (MTA Angelus) as a pulpotomy medicament for primary teeth. Seventy primary teeth in 33 patients were randomly divided into two groups, MTA Angelus (n = 34) and Bio-C Pulpo (n = 36). Clinical and radiographic follow-up examinations were conducted at seven days (except radiographic follow-up), and at one, three, six and 12 months. At 12 months, the clinical success rate of the MTA Angelus group was 100 percent (28 out of 28), and the radiographic success rate was 100 percent (28 out of 28). In comparison, the clinical success rate for the Bio-C Pulpo group was 100 percent (29 out of 29), and the radiographic success rate was 100 percent (29 out of 29). No significant differences were found between the groups at any follow-up evaluation. According to Fisher´s exact test, a significant difference was observed between the pulpotomy agent and tooth discoloration (p < 0.001). The success rates were 100% for the Bio-C Pulpo group, with no case of discoloration, and 10.31% for the MTA Angelus group. Both MTA Angelus and Bio-C Pulp pulpotomy medicaments are appropriate options for pulpotomies in primary teeth, and enable high clinical and radiographic success rates. However, more long-term studies are required to test the new Bio-C Pulpo medicament.",2020,"The success rates were 100% for the Bio-C Pulpo group, with no case of discoloration, and 10.31% for the MTA Angelus group.","['Seventy primary teeth in 33 patients', 'pulpotomies']","['new stain-free tricalcium silicate cement (Bio-C Pulpo) versus a conventional white MTA (MTA Angelus', 'new stain-free tricalcium silicate cement']","['success rates', 'pulpotomy agent and tooth discoloration', 'radiographic success rate', 'clinical success rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1259508', 'cui_str': 'MTA-Angelus'}]","[{'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",33.0,0.0258348,"The success rates were 100% for the Bio-C Pulpo group, with no case of discoloration, and 10.31% for the MTA Angelus group.","[{'ForeName': 'Suéllen Priscilla Rodrigues de', 'Initials': 'SPR', 'LastName': 'Lima', 'Affiliation': 'Department of Pediatric Dentistry, Araçatuba Dental School, Universidade Estadual Paulista, Araçatuba, SP, Brazil.'}, {'ForeName': 'Greissy Lopes Dos', 'Initials': 'GLD', 'LastName': 'Santos', 'Affiliation': 'Department of Oral Medicine and Pediatric Dentistry, Universidade Estadual de Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ferelle', 'Affiliation': 'Department of Oral Medicine and Pediatric Dentistry, Universidade Estadual de Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'Solange de Paula', 'Initials': 'SP', 'LastName': 'Ramos', 'Affiliation': 'Department of Histology, Center of Biological Sciences, Universidade Estadual de Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'Juliano Pelim', 'Initials': 'JP', 'LastName': 'Pessan', 'Affiliation': 'Department of Pediatric Dentistry, Araçatuba Dental School, Universidade Estadual Paulista, Araçatuba, SP, Brazil.'}, {'ForeName': 'Cássia Cilene', 'Initials': 'CC', 'LastName': 'Dezan-Garbelini', 'Affiliation': 'Department of Oral Medicine and Pediatric Dentistry, Universidade Estadual de Londrina, Londrina, PR, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0102']
1816,31822203,"Processes of change in cognitive behavioral therapy for treatment-resistant depression: psychological flexibility, rumination, avoidance, and emotional processing.","Recent clinical research suggests that facilitating psychological flexibility and emotional processing and decreasing rumination and avoidance are important tasks of treatment for disorders characterized by entrenched patterns of psychopathology, such as major depressive disorder. The current study examined these processes as predictors of treatment outcomes in a subsample of depressed adult patients ( n  = 49) who had not fully responded to antidepressant medication and were randomized to receive cognitive-behavioral therapy (CBT). Target variables were coded from session recordings at baseline and in the vicinity of two therapeutic transition points: a sudden gain (improvement) and a transient spike in depression symptoms, or at similar periods for those without such transitions. Results indicated that psychological flexibility during the pre-sudden gain period predicted less depression at 12-month follow-up, beyond baseline symptoms and other co-occurring processes. Interaction analyses revealed that when flexibility was low during the post-spike period, avoidance and rumination predicted higher depressive symptoms, whereas emotional processing predicted lower symptoms at the 12-month follow-up. When flexibility was high, none of these variables were associated with outcome. Together, these findings highlight psychological flexibility as a key therapeutic target in CBT for treatment-resistant depression and might have implications for relapse prevention.",2020,"Interaction analyses revealed that when flexibility was low during the post-spike period, avoidance and rumination predicted higher depressive symptoms, whereas emotional processing predicted lower symptoms at the 12-month follow-up.",['subsample of depressed adult patients ( n\u2009 =\u200949) who had not fully responded to antidepressant medication and were randomized to receive'],"['cognitive-behavioral therapy (CBT', 'cognitive behavioral therapy']",['psychological flexibility'],"[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0310072,"Interaction analyses revealed that when flexibility was low during the post-spike period, avoidance and rumination predicted higher depressive symptoms, whereas emotional processing predicted lower symptoms at the 12-month follow-up.","[{'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Yasinski', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Adele M', 'Initials': 'AM', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'C Beth', 'Initials': 'CB', 'LastName': 'Ready', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Abel', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Görg', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Mood Disorders Centre, University of Exeter, Exeter, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1699972']
1817,32880954,Relative accuracy of social and medical determinants of suicide in electronic health records.,"OBJECTIVE


This paper compares the accuracy of predicting suicide from Social Determinants of Health (SDoH) or history of illness.
POPULATION STUDIED


5 313 965 Veterans who at least had two primary care visits between 2008 and 2016.
STUDY DESIGN


The dependent variable was suicide or intentional self-injury. The independent variables were 10 495 International Classification of Disease (ICD) Version 9 codes, age, and gender. The ICD codes included 40 V-codes used for measuring SDoH, such as family disruption, family history of substance abuse, lack of education, legal impediments, social isolation, unemployment, and homelessness. The sample was randomly divided into training (90 percent) and validation (10 percent) sets. Area under the receiver operating characteristic (AROC) was used to measure accuracy of predictions in the validation set.
PRINCIPAL FINDINGS


Separate analyses were done for inpatient and outpatient codes; the results were similar. In the hospitalized group, the mean age was 67.2 years, and 92.1 percent were male. The mean number of medical diagnostic codes during the study period was 37; and 12.9 percent had at least one SDoH V-code. At least one episode of suicide or intentional self-injury occurred in 1.89 percent of cases. SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold). An index of 40 SDoH codes predicted suicide or intentional self-injury with an AROC of 0.64. An index of 10 445 medical diagnoses, without SDoH V-codes, had AROC of 0.77. The combined SDoH and medical diagnoses codes also had AROC of 0.77.
CONCLUSION


In predicting suicide or intentional self-harm, SDoH V-codes add negligible information beyond what is already available in medical diagnosis codes.
IMPLICATIONS FOR PRACTICE


Policies that affect SDoH (eg, housing policies, resilience training) may not have an impact on suicide rates, if they do not change the underlying medical causes of SDoH.",2020,"SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold).","['hospitalized group, the mean age was 67.2\xa0years, and 92.1 percent were male', '313\xa0965 Veterans who at least had two primary care visits between 2008 and 2016', '5']",[],"['mean number of medical diagnostic codes', 'episode of suicide or intentional self-injury']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0853089', 'cui_str': 'Intentional self-injury'}]",,0.0424179,"SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold).","[{'ForeName': 'Farrokh', 'Initials': 'F', 'LastName': 'Alemi', 'Affiliation': 'Department of Health Administration and Policy, George Mason University, Virginia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Avramovic', 'Affiliation': 'Department of Health Administration and Policy, George Mason University, Virginia.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Renshaw', 'Affiliation': 'Department of Psychology, George Mason University, Virginia.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Kanchi', 'Affiliation': 'Department of Population Health, New York University, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Department of Population Health, New York University, New York.'}]",Health services research,['10.1111/1475-6773.13540']
1818,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
1819,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
1820,32878764,"Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.","INTRODUCTION


Automated systems for ventilator management to date have been either fully heuristic rule-based systems or based on a combination of simple physiological models and rules. These have been shown to reduce the duration of mechanical ventilation in simple to wean patients. At present, there are no published studies that evaluate the effect of systems that use detailed physiological descriptions of the individual patient.The BEACON Caresystem is a model-based decision support system that uses mathematical models of patients' physiology in combination with models of clinical preferences to provide advice on appropriate ventilator settings. An individual physiological description may be particularly advantageous in selecting the appropriate therapy for a complex, heterogeneous, intensive care unit (ICU) patient population.
METHODS AND ANALYSIS


Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting. The trial will enrol 274 participants across multiple London National Health Service ICUs. The trial will use a primary outcome of duration of mechanical ventilation until successful extubation.
ETHICS AND DISSEMINATION


Safety oversight will be under the direction of an independent committee of the study sponsor. Study approval was obtained from the regional ethics committee of the Health Research Authority (HRA), (Research Ethic Committee (REC) reference: 17/LO/0887. Integrated Research Application System (IRAS) reference: 226610. Results will be disseminated through international critical care conference/symposium and publication in peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov under NCT03249623. This research is registered with the National Institute for Health Research under CPMS ID: 34831.",2020,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.",['274 participants across multiple London National Health Service ICUs'],"['Intensive Care Weaning (iCareWean) protocol', 'Intenive Care weaning (iCareWean']",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.189947,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Vizcaychipi', 'Affiliation': 'APMIC, Imperial College London, London, UK m.vizcaychipi@imperial.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Research Trial Unit, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dan Stleper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Center for Model-based Medical Decision Support, Aalborg Universitet, Aalborg, Denmark.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Anaesthetic Department, West Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Magill Department of Anaesthesia and Intensive Care Medicine, Chelsea and Westminster Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Osman', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Moreno-Cuesta', 'Affiliation': 'Anaesthetic Department, North Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Department of Health Science and Technology, Aalborg Universitet Institut for Medicin og Sundhedsteknologi, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-042145']
1821,32888340,"Randomized Double-blind Trial of Intramuscular Droperidol, Ziprasidone, and Lorazepam for Acute Undifferentiated Agitation in the Emergency Department.","BACKGROUND


The optimal agent to treat acute agitation in the emergency department (ED) has not been determined. The objective of this study was to compare the effectiveness and safety of intramuscular droperidol, ziprasidone, and lorazepam for acute agitation in the ED.
METHODS


This was a randomized, double-blind trial of ED patients with acute agitation requiring parenteral sedation. The study was conducted under exception from informed consent (21 CFR 50.24) from July 2004 to March 2005. Patients were randomized to receive 5 mg of droperidol, 10 mg of ziprasidone, 20 mg of ziprasidone, or 2 mg of lorazepam intramuscularly. We recorded Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO 2  ), and pulse oximetry (SpO 2  ) at 0, 15, 30, 45, 60, 90, and 120 minutes as well as QTc durations and dysrhythmias. Respiratory depression was defined as a change in ETCO 2  consistent with respiratory depression or SpO 2   < 90%. The primary outcome was the proportion of patients adequately sedated (AMSS ≤ 0) at 15 minutes.
RESULTS


We enrolled 115 patients. Baseline AMSS scores were similar between groups. For the primary outcome, adequate sedation at 15 minutes, droperidol administration was effective in 16 of 25 (64%) patients, compared to seven of 28 (25%) for 10 mg of ziprasidone, 11 of 31 (35%) for 20 mg of ziprasidone, and nine of 31 (29%) for lorazepam. Pairwise comparisons revealed that droperidol was more effective that the other medications, with 39% (95% confidence interval [CI] = 3% to 54%) more compared to 20 mg of ziprasidone and 33% (95% CI = 8% to 58%) more compared to lorazepam. There was no significant difference between groups in need of additional rescue sedation. Numerically, respiratory depression was lower with droperidol (3/25 [12%]) compared to 10 mg of ziprasidone (10/28 [36%]), 20 mg of ziprasidone (12/31 [39%]), or lorazepam (15/31 [48%]). One patient receiving 20 mg of ziprasidone required intubation to manage an acute subdural hematoma. No patients had ventricular dysrhythmias. QTc durations were similar in all groups.
CONCLUSIONS


Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the ED and caused fewer episodes of respiratory depression.",2020,"CONCLUSIONS


Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the emergency department and caused fewer episodes of respiratory depression.","['ED patients with acute agitation requiring parenteral sedation', 'Acute Undifferentiated Agitation in the Emergency Department', 'We enrolled 115 patients']","['Droperidol', 'ziprasidone 20mg required intubation', 'droperidol', 'Intramuscular Droperidol, Ziprasidone and Lorazepam', 'droperidol 5mg, ziprasidone 10mg, ziprasidone 20mg, or lorazepam', 'lorazepam', 'ziprasidone', 'droperidol, ziprasidone, and lorazepam']","['proportion of patients adequately sedated (AMSS≤0', 'adequate sedation', 'episodes of respiratory depression', 'Respiratory depression', 'effectiveness and safety', 'QTc durations and dysrhythmias', 'Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO2), and pulse oximetry (SpO2', 'ventricular dysrhythmias', 'respiratory depression', 'need of additional rescue sedation', 'Baseline AMSS scores', 'QTc durations']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C1126071', 'cui_str': 'ziprasidone 20 MG'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0278061', 'cui_str': 'Altered mental status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",115.0,0.42974,"CONCLUSIONS


Droperidol was more effective than lorazepam or either dose of ziprasidone for the treatment of acute agitation in the emergency department and caused fewer episodes of respiratory depression.","[{'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Martel', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Miner', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'and the, Department of Emergency Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jon B', 'Initials': 'JB', 'LastName': 'Cole', 'Affiliation': 'From the, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14124']
1822,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2020,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
1823,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
1824,32877599,Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma.,"BACKGROUND


In the previously reported primary analysis of this phase 3 trial, 12 months of adjuvant dabrafenib plus trametinib resulted in significantly longer relapse-free survival than placebo in patients with resected stage III melanoma with  BRAF  V600E or V600K mutations. To confirm the stability of the relapse-free survival benefit, longer-term data were needed.
METHODS


We randomly assigned 870 patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations to receive 12 months of oral dabrafenib (at a dose of 150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos. The primary end point was relapse-free survival. Here, we report 5-year results for relapse-free survival and survival without distant metastasis as the site of the first relapse. Overall survival was not analyzed, since the required number of events to trigger the final overall survival analysis had not been reached.
RESULTS


The minimum duration of follow-up was 59 months (median patient follow-up, 60 months for dabrafenib plus trametinib and 58 months for placebo). At 5 years, the percentage of patients who were alive without relapse was 52% (95% confidence interval [CI], 48 to 58) with dabrafenib plus trametinib and 36% (95% CI, 32 to 41) with placebo (hazard ratio for relapse or death, 0.51; 95% CI, 0.42 to 0.61). The percentage of patients who were alive without distant metastasis was 65% (95% CI, 61 to 71) with dabrafenib plus trametinib and 54% (95% CI, 49 to 60) with placebo (hazard ratio for distant metastasis or death, 0.55; 95% CI, 0.44 to 0.70). No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
CONCLUSIONS


In the 5-year follow-up of a phase 3 trial involving patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations, 12 months of adjuvant therapy with dabrafenib plus trametinib resulted in a longer duration of survival without relapse or distant metastasis than placebo with no apparent long-term toxic effects. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov number, NCT01682083; EudraCT number, 2012-001266-15.).",2020,"No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
","['870 patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations to receive 12 months of', 'patients with resected stage III melanoma with  BRAF  V600E or V600K mutations', 'Stage III Melanoma', 'patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations, 12 months of adjuvant therapy with']","['oral dabrafenib (at a dose of 150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos', 'dabrafenib plus trametinib', 'placebo']","['Overall survival', 'alive without relapse', 'relapse-free survival', 'incidence or severity of serious adverse events', 'longer duration of survival without relapse or distant metastasis', 'alive without distant metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",870.0,0.76883,"No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
","[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion Sileni', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa2005493']
1825,32882429,"A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction.","IMPORTANCE


Obstructive meibomian gland dysfunction (MGD) can be refractory to medical therapy. Intraductal meibomian gland (MG) probing may offer a potential therapeutic approach for these patients, but no randomized trials have been conducted to date.
OBJECTIVE


To assess clinical changes after intraductal MG probing for patients with refractory obstructive meibomian gland dysfunction.
DESIGN


Randomized, double-masked, sham-controlled clinical trial.
SETTING


Single-center, tertiary referral center.
PARTICIPANTS


42 patients with refractory obstructive MGD associated with lid tenderness.
INTERVENTIONS


Enrolled patients received one of the following treatments: 1) MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment. The probing was performed on the upper lids of both eyes.
MAIN OUTCOME MEASURES


Primary outcome measures were symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT). Secondary outcome measures were other clinical signs. Safety of the procedure was also evaluated by investigating the treatment-related adverse events. At baseline and 4 weeks after the procedure a masked observer evaluated the following outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS).
RESULTS


Compared to baseline, the MG probing/Blephamide® group showed significant improvements in both OSDI and SANDE scores and the MG probing/GenTeal group demonstrated a significant improvement only in SANDE score. In contrast, the Sham/GenTeal group did not show any statistically significant changes in symptoms. There were no statistically significant changes in clinical signs in any group at the 4-week visit, except for improvement of lid tenderness in the sham probing group.
CONCLUSIONS


MG probing/Blephamide® results in a significant improvement in symptoms in patients with refractory obstructive MGD without any significant effect on clinical signs. Larger studies are warranted to determine the efficacy of MG probing.
TRIAL REGISTRATION


Clinicaltrials.gov(identifier NCT02256969, Filed on 08/13/2014).",2020,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","['patients with refractory obstructive meibomian gland dysfunction', 'patients with refractory obstructive MGD', 'obstructive meibomian gland dysfunction', '42 patients with refractory obstructive MGD associated with lid tenderness', 'Single-center, tertiary referral center']","['intraductal meibomian gland probing with or without topical antibiotic/steroid', 'MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment']","[""outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS"", 'SANDE score', 'symptoms', 'lid tenderness', 'OSDI and SANDE scores', 'clinical signs', 'symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1512936', 'cui_str': 'Intraductal route'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038670', 'cui_str': 'Sulfacetamide'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0718966', 'cui_str': 'Blephamide'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0720651', 'cui_str': 'GenTeal'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",42.0,0.276796,"There were no statistically significant changes in clinical signs in any group at 4-week visit except for improvement of lid tenderness in the sham probing group.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kheirkhah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Department of Ophthalmology, Long School of Medicine, University of Texas Health at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Hidenaga', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Girgis', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Arsia', 'Initials': 'A', 'LastName': 'Jamali', 'Affiliation': 'Center for Translational Ocular Immunology, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Ciolino', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA. Electronic address: Joseph_Ciolino@meei.harvard.edu.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Hamrah', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Center for Translational Ocular Immunology, USA; Cornea Service, New England Eye Center, And Department of Ophthalmology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. Electronic address: pedram.hamrah@tufts.edu.'}]",The ocular surface,['10.1016/j.jtos.2020.08.008']
1826,32887793,Fatty Acid Supplementation and Socioemotional Outcomes: Secondary Analysis of a Randomized Trial.,"BACKGROUND AND OBJECTIVES


Children born preterm experience socioemotional difficulties, including increased risk of autism spectrum disorder (ASD). In this secondary analysis, we tested the effect of combined docosahexaenoic acid (DHA) and arachidonic acid (AA) supplementation during toddlerhood on caregiver-reported socioemotional outcomes of children born preterm. We hypothesized that children randomly assigned to DHA + AA would display better socioemotional outcomes compared with those randomly assigned to a placebo.
METHODS


Omega Tots was a single-site randomized, fully masked, parallel-group, placebo-controlled trial. Children ( N  = 377) were 10 to 16 months at enrollment, born at <35 weeks' gestation, and assigned to 180 days of daily 200-mg DHA + 200-mg AA supplementation or a placebo (400 mg corn oil). Caregivers completed the Brief Infant-Toddler Social and Emotional Assessment and the Pervasive Developmental Disorders Screening Test-II, Stage 2 at the end of the trial. Liner mixed models and log-binomial regression compared socioemotional outcomes between the DHA + AA and placebo groups.
RESULTS


Outcome data were available for 83% of children ( n   treatment  = 161;  n   placebo  = 153). Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant. Children randomly assigned to DHA + AA had a decreased risk of scoring at-risk for ASD on the Pervasive Developmental Disorders Screening Test-II, Stage 2 (21% vs 32%; risk ratio = 0.66 [95% confidence interval: 0.45 to 0.97]; risk difference = -0.11 [95% confidence interval: -0.21 to -0.01]) compared with children randomly assigned to a placebo.
CONCLUSIONS


No evidence of benefit of DHA + AA supplementation on caregiver-reported outcomes of broad socioemotional development was observed. Supplementation resulted in decreased risk of clinical concern for ASD. Further exploration in larger samples of preterm children and continued follow-up of children who received DHA + AA supplementation as they approach school age is warranted.",2020,Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant.,"['children born preterm', 'Children born preterm', ""Children ( N  = 377) were 10 to 16 months at enrollment, born at <35 weeks' gestation""]","['placebo', 'combined docosahexaenoic acid (DHA) and arachidonic acid (AA) supplementation', 'DHA + 200-mg AA supplementation or a placebo', 'Fatty Acid Supplementation and Socioemotional Outcomes', 'DHA + AA supplementation', 'DHA + AA']","['risk of clinical concern for ASD', 'Brief Infant-Toddler Social and Emotional Assessment scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",377.0,0.782376,Differences between DHA + AA and placebo groups on Brief Infant-Toddler Social and Emotional Assessment scores were of small magnitude (Cohen's  d  ≤ 0.15) and not statistically significant.,"[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Centers for Biobehavioral Health and kelly.boone@nationwidechildrens.org.'}, {'ForeName': 'Andria', 'Initials': 'A', 'LastName': 'Parrott', 'Affiliation': 'Centers for Biobehavioral Health and.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': 'Centers for Biobehavioral Health and.'}, {'ForeName': 'Keith Owen', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute and Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Pediatrics, and.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Norris Turner', 'Affiliation': 'Division of Epidemiology, College of Public Health, and.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': 'Centers for Biobehavioral Health and.'}]",Pediatrics,['10.1542/peds.2020-0284']
1827,32888740,"Levels of antibodies specific to diphtheria toxoid, tetanus toxoid, and Haemophilus influenzae type b in healthy children born to Tdap-vaccinated mothers.","INTRODUCTION


Vaccination of pregnant women protects both women and their newborns against some infectious diseases. Thailand implemented tetanus toxoid (TT) vaccination of pregnant women in 1977, which was replaced by tetanus-diphtheria toxoid (dT) vaccination in 2005. The tetanus-diphtheria-acellular pertussis (Tdap) vaccine has been recommended for pregnant women at 27-36 weeks of gestation since 2012 in several countries. Data on antibody responses to diphtheria toxoid (DT), TT, and Hemophilus influenzae type b (Hib) induced by combined vaccines in children born to TT-vaccinated and/or Tdap-vaccinated mothers are limited.
MATERIAL AND METHODS


We investigated anti-DT, anti-TT, and anti-Hib IgG responses in a cohort of Thai children (ClinicalTrial.gov NCT02408926) born to mothers who received a TT-containing and/or the Tdap vaccine during pregnancy. Children born to Tdap-vaccinated mothers were randomized to receive either a hexavalent (Infanrix-hexa) or pentavalent (Quinvaxem) vaccine, whereas children born to TT-vaccinated mothers received only Quinvaxem vaccine at 2, 4, 6, and 18 months of age. IgG levels were evaluated at birth (cord blood), 2 (pre-primary), 7 (post-primary), 18 (pre-booster), and 19 months of age (post-booster) using a commercially available enzyme-linked immunoassay.
RESULTS


Seroprotective concentrations of anti-DT, anti-TT, and anti-Hib IgG were achieved in >90% and >99% of children following primary and booster vaccination, respectively. Among children born to Tdap-vaccinated mothers, the pentavalent vaccine induced higher levels of anti-Hib IgG than the hexavalent vaccine after primary and booster vaccination. Significantly higher anti-Hib IgG levels were observed among children receiving the pentavalent vaccine and who were born to TT-vaccinated mothers than among children receiving the pentavalent vaccine and born to Tdap-vaccinated mothers after primary and booster vaccination.
CONCLUSIONS


Vaccination with a TT-containing and/or the Tdap vaccine during pregnancy did not compromise the seroprotection rate achieved following primary and booster immunization in individuals receiving either the pentavalent or hexavalent vaccine.",2020,"Among children born to Tdap-vaccinated mothers, the pentavalent vaccine induced higher levels of anti-Hib IgG than the hexavalent vaccine after primary and booster vaccination.","['cohort of Thai children (ClinicalTrial.gov NCT02408926) born to mothers who received a TT-containing and/or the Tdap vaccine during pregnancy', 'pregnant women protects both women and their newborns against some infectious diseases', 'children born to Tdap-vaccinated mothers', 'pregnant women at 27-36\xa0weeks of gestation since 2012 in several countries', 'pregnant women in 1977, which was replaced by tetanus-diphtheria toxoid (dT) vaccination in 2005', 'Children born to Tdap-vaccinated mothers', 'children born to TT-vaccinated and/or Tdap-vaccinated mothers', 'healthy children born to Tdap-vaccinated mothers']","['pentavalent vaccine', 'tetanus-diphtheria-acellular pertussis (Tdap) vaccine', 'diphtheria toxoid, tetanus toxoid, and Haemophilus influenzae type b', 'TT-containing and/or the Tdap vaccine', 'influenzae type b (Hib) induced by combined vaccines', 'Thailand implemented tetanus toxoid (TT) vaccination', 'TT-vaccinated mothers received only Quinvaxem vaccine', 'hexavalent (Infanrix-hexa) or pentavalent (Quinvaxem) vaccine', 'diphtheria toxoid (DT), TT, and Hemophilus']","['Seroprotective concentrations of anti-DT, anti-TT, and anti-Hib IgG', 'anti-Hib IgG levels', 'seroprotection rate', 'IgG levels']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521124', 'cui_str': 'Against'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1299987', 'cui_str': 'REPLACED BY'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C3661302', 'cui_str': 'Infanrix hexa'}, {'cui': 'C0018479', 'cui_str': 'Haemophilus'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0583513,"Among children born to Tdap-vaccinated mothers, the pentavalent vaccine induced higher levels of anti-Hib IgG than the hexavalent vaccine after primary and booster vaccination.","[{'ForeName': 'Nasamon', 'Initials': 'N', 'LastName': 'Wanlapakorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Academic Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Maertens', 'Affiliation': 'Center for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Thanunrat', 'Initials': 'T', 'LastName': 'Thongmee', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Donchida', 'Initials': 'D', 'LastName': 'Srimuan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thaksaporn', 'Initials': 'T', 'LastName': 'Thatsanathorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Center for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Leuridan', 'Affiliation': 'Center for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Poovorawan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: 1yong.p@chula.ac.th.'}]",Vaccine,['10.1016/j.vaccine.2020.08.058']
1828,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
1829,32889324,Predict overall survival of spinal conventional chordoma: Development and assessment of a new predictive nomogram.,"OBJECTIVE


To predict the 5-year overall survival (OS) rate in patients with conventional chordoma of the spine PATIENTS AND METHODS: The Surveillance, Epidemiology, and End Results (SEER) Registry was used to identify patients with conventional chordoma of the spine from 1994 to 2013. The entire cohort(n = 294) was randomly divided into training (n = 147) and validation (n = 147) cohorts to construct a nomogram. We used the univariate Log-rank test and multivariate Cox model to examine the independent prognostic factors associated with OS. These prognostic factors were integrated to construct a nomogram through R studio. The predictive and validating capacity of the nomogram was calculated by Harrell's concordance index (C-index) and calibration curves.
RESULTS


A total of 294 patients were identified with conventional chordoma of the spine. The patients' age at diagnosis, tumor size, EOD (extent of disease), and treatment were independent prognostic factors and associated with OS. These prognostic factors were incorporated to construct a nomogram. The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively. Internal and external calibration curves for 5-year OS showed excellent matching between nomogram prediction and observed outcomes.
CONCLUSIONS


The findings of this study provide population-based estimates of patients with conventional chordoma of the spine. Using this nomogram, surgeons can classify patients into different risk groups and achieve individualized treatment.",2020,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","['patients with conventional chordoma of the spine', 'patients with conventional chordoma of the spine from 1994 to 2013', '294 patients were identified with conventional chordoma of the spine']",[],"['Surveillance, Epidemiology, and End Results (SEER', '5-year overall survival (OS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008487', 'cui_str': 'Chordoma'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",294.0,0.0249893,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","[{'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Kehan', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huiren', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wang.huiren@zs-hospital.sh.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106174']
1830,32893745,"Vitamin E and ginseng supplementation to enhance female sexual function: a randomized, double-blind, placebo-controlled, clinical trial.","Female sexual disorders (FSD) are a spectrum of disorders common among women, especially in their middle age, which can reduce the female quality of life substantially. We aimed to evaluate the effects of a combined vitamin E and ginseng supplement on amelioration of female sexual dysfunction. In a 6-week, double-blind, randomized, placebo-controlled clinical trial, participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire, were randomly allocated to receive the supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily. The primary outcome in our trial was the change in the FSFI total score. Sixty-nine participants were enrolled, but only 31 in each group completed the trial. Changes in the FSFI total score and its domain scores were significant during the trial course within each group. However, the supplement only ameliorated desire and satisfaction domains superior to the placebo. In case of the total score and other domains, the changes were insignificantly different between the treatment groups. Although our study could not find additional benefits for the vitamin E and ginseng supplement over placebo in enhancing sexual function overall, the supplement worked better in enhancing sexual desire and satisfaction.",2020,"In case of the total score and other domains, the changes were insignificantly different between the treatment groups.","['Female sexual disorders (FSD', 'participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire', 'Sixty-nine participants were enrolled, but only 31 in each group completed the trial']","['Vitamin E and ginseng supplementation', 'supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily', 'combined vitamin E and ginseng supplement', 'placebo', 'vitamin E and ginseng supplement over placebo']","['sexual desire and satisfaction', 'FSFI total score and its domain scores', 'amelioration of female sexual dysfunction', 'female sexual function', 'FSFI total score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237873', 'cui_str': 'Sexual Disorders, Physiological'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C1035215', 'cui_str': 'Ginseng, Siberian'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}]",69.0,0.393237,"In case of the total score and other domains, the changes were insignificantly different between the treatment groups.","[{'ForeName': 'Kiandokht', 'Initials': 'K', 'LastName': 'Ghamari', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': 'Infertility Ward, Arash Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Jafarinia', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Tadayon Najafabadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Shokraee', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Esalatmanesh', 'Affiliation': 'Infertility Ward, Arash Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}]",Women & health,['10.1080/03630242.2020.1803465']
1831,32894239,The effect of aerobic exercise training on postmenopausal patients with knee osteoarthritis.,"BACKGROUND


Knee osteoarthritis (OA) is a common musculoskeletal problem encountered in the postmenopausal period.
OBJECTIVE


This study aimed to determine the impact of aerobic exercise on functional limitation, exercise tolerance, and performance tests in postmenopausal women with knee OA.
METHODS


A total of 50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled. OA-specific physical performance tests (40 m Fast-Paced Walk Test (40mFPWT), 30 s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS) were performed. Fifty patients were randomized to either the treatment or control groups. The treatment group received an additional aerobic exercise training along with a combined physiotherapy program for six weeks. The aerobic exercise program was carried out by the same physiotherapist every weekday (five days) for six weeks. The control group only received a combined physiotherapy program for six weeks.
RESULTS


The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
CONCLUSIONS


Consequently, this study provides an insight into the efficacy of the aerobic exercise program applied along with a combined physiotherapy program in postmenopausal women with knee OA.",2020,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","['postmenopausal patients with knee osteoarthritis', 'Fifty patients', '50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled', 'postmenopausal women with knee OA']","['combined physiotherapy program', 'additional aerobic exercise training', 'OA-specific physical performance tests (40\xa0m Fast-Paced Walk Test (40mFPWT', 'aerobic exercise', 'aerobic exercise program', 'aerobic exercise training']","['30\xa0s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS', 'performance tests, WOMAC scores, and the distance covered in 6MWT', 'functional limitation, exercise tolerance, and performance tests', 'VAS scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",50.0,0.040622,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","[{'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Kılıç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Demirgüç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sanko University, Gaziantep, Turkey.'}, {'ForeName': 'Saniye Aydoğan', 'Initials': 'SA', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Esra Dilek', 'Initials': 'ED', 'LastName': 'Keskin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Müyesser', 'Initials': 'M', 'LastName': 'Aras', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191712']
1832,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2020,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
1833,32892178,Inhaled nitric oxide (iNO) for preventing prematurity-related bronchopulmonary dysplasia (BPD): 7-year follow-up of the European Union Nitric Oxide (EUNO) trial.,"Objectives Most studies of inhaled nitric oxide (iNO) for prevention of bronchopulmonary dysplasia (BPD) in premature infants have focused on short-term mortality and morbidity. Our aim was to determine the long-term effects of iNO. Methods A 7-year follow-up was undertaken of infants entered into a multicenter, double-blind, randomized, placebo-controlled trial of iNO for prevention of BPD in premature infants born between 24 and 28 weeks plus six days of gestation. At 7 years, survival and hospital admissions since the 2-year follow-up, home oxygen therapy in the past year, therapies used in the previous month and growth assessments were determined. Questionnaires were used to compare general health, well-being, and quality of life. Results A total of 305 children were assessed. No deaths were reported. Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar. Two patients who received iNO and one who received placebo had received home oxygen therapy. There were no significant differences in any questionnaire-documented health outcomes. Conclusions iNO for prevention of BPD in very premature infants with respiratory distress did not result in long-term benefits or adverse long-term sequelae. In the light of current evidence, routine use of iNO cannot be recommended for prevention of BPD in preterm infants.",2020,"Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar.","['preterm infants', 'premature infants', 'prematurity-related bronchopulmonary dysplasia (BPD', 'premature infants born between 24 and 28\xa0weeks plus six days of gestation', '305 children']","['Inhaled nitric oxide (iNO', 'inhaled nitric oxide (iNO', 'placebo', 'home oxygen therapy']","['questionnaire-documented health outcomes', 'survival and hospital admissions since the 2-year follow-up, home oxygen therapy', 'general health, well-being, and quality of life', 'Rates of hospitalization for respiratory problems']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",305.0,0.299218,"Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Decobert', 'Affiliation': 'Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'University of Leicester Centre for Medicine, Leicester, UK.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'University of Oulu and Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Helmut D', 'Initials': 'HD', 'LastName': 'Hummler', 'Affiliation': 'Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Baldvin', 'Initials': 'B', 'LastName': 'Jonsson', 'Affiliation': 'Karolinska University Hospital and Institute, Stockholm, Sweden.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sánchez Luna', 'Affiliation': 'Hospital General Universitario ""Gregorio Marañón,"" Madrid, Spain.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Overmeire', 'Affiliation': 'Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Virgilio P', 'Initials': 'VP', 'LastName': 'Carnielli', 'Affiliation': 'Polytechnical University of Marche, Ancona, Italy.'}, {'ForeName': 'Jim L', 'Initials': 'JL', 'LastName': 'Potenziano', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Mercier', 'Affiliation': 'Université Paris Diderot, Paris, France.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0164']
1834,32890016,Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial.,"BACKGROUND


Atelectasis is common in patients undergoing prolonged deep sedation outside the operating theatre. High-flow nasal oxygen (HFNO) produces positive airway pressure which, hypothetically, should improve lung atelectasis, but this has not been investigated.
OBJECTIVE


We investigated whether HFNO ameliorates postprocedural atelectasis and compared the influences of HFNO and facial oxygen by mask on postprocedural outcomes.
DESIGN


A single-blind, open-label single-institution randomised controlled trial.
SETTING


A single university hospital, from February 2017 to July 2019.
PATIENTS


A total of 59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation were randomly allocated to two groups.
INTERVENTION


These patients randomly received HFNO (oxygen flow 10 l min before sedation and 50 l min during the procedure) or a conventional oxygen face mask (oxygen flow 10 l min) during the procedure.
MAIN OUTCOME MEASURES


Changes in the area of lung atelectasis calculated on the basis of chest CT images and also recovery profiles were compared between the two groups.
RESULTS


The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313). However, the numbers of patients requiring oxygen supplementation in the recovery room and during transport from the recovery room to the ward did not differ significantly between groups (24.1 vs. 50.0%; P = 0.0596).
CONCLUSION


Our results suggested that HFNO ameliorates lung atelectasis after prolonged deep sedation in patients receiving CT-guided hepatic tumour radiofrequency ablation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03019354.",2020,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","['A single university hospital, from February 2017 to July 2019', '59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation', 'patients undergoing prolonged deep sedation outside the operating theatre', 'patients receiving CT-guided hepatic tumour radiofrequency ablation']","['high-flow nasal oxygen', 'HFNO', 'computerised tomography', 'HFNO (oxygen flow 10\u200al\u200amin before sedation and 50\u200al\u200amin during the procedure) or a conventional oxygen face mask (oxygen flow 10\u200al\u200amin) during the procedure', 'High-flow nasal oxygen (HFNO']","['numbers of patients requiring oxygen supplementation', 'area of lung atelectasis calculated on the basis of chest CT images and', 'postprocedural atelectasis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023903', 'cui_str': 'Neoplasm of liver'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",59.0,0.224667,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","[{'ForeName': 'Chung-Chih', 'Initials': 'CC', 'LastName': 'Shih', 'Affiliation': 'From the Department of Anaesthesiology (C-CS, Y-HC, Y-JH, P-JL, C-YW) and Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan, ROC (P-CL).'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yueh-Hsun', 'Initials': 'YH', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Pei-Jing', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001324']
1835,32895647,Comparison of an Herbal- and a 0.12% Chlorhexidine-based Oral Rinse as Adjuncts to Nonsurgical Mechanical Debridement in the Management of Peri-implant Mucositis: A Randomised Controlled Trial.,"PURPOSE


In the present randomised controlled trial (RCT), the authors hypothesise that herbal-based oral rinses are as effective as 0.12% chlorhexidine when used as adjuncts to non-surgical mechanical debridement (MD) in the management of peri-implant mucositis. The aim of the present RCT was to compare the efficacy of an herbal oral rinse with a 0.12% chlorhexidine-based oral rinse when used as adjuncts to non-surgical MD in the treatment of peri-implant mucositis.
MATERIALS AND METHODS


Adult patients with peri-implant mucositis were included. Participants were randomly allocated into 3 groups. In group 1, patients only underwent non-surgical MD. In groups 2 and 3, patients underwent non-surgical MD with adjunct rinsing with an herbal- and 0.12% CHX-based oral rinse, respectively. Peri-implant plaque index (PI) and bleeding-on-probing (BOP) and probing-depth (PD) were assessed at baseline and at 3, 6, and 12 weeks. Group comparisons were done and p < 0.01 was considered statistically significant.
RESULTS


Forty-eight patients with peri-implant mucositis (16, 16, and 16 in groups 1, 2 and 3, respectively) were included. At baseline, there was no difference in PI, PD, BOP in all groups. In group 1, there was no statistically significant difference in PI and BOP at 6, and 12 weeks of follow-up compared with baseline. In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up. In group 1, there was no statistically significant difference in PD at all time intervals. In groups 2 and 3, PD was statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up. In groups 2 and 3, there was no statistically significant difference in PI, BOP and PD at all intervals.
CONCLUSION


Herbal- and 0.12% CHX-based oral rinses are useful adjuncts to MD for the treatment of peri-implant mucositis.",2020,"In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up.","['Peri-implant Mucositis', 'Forty-eight patients with peri-implant mucositis (16, 16, and 16 in groups 1, 2 and 3, respectively) were included', 'Adult patients with peri-implant mucositis were included']","['chlorhexidine-based oral rinse', 'herbal oral rinse', 'CHX-based oral rinses', 'Chlorhexidine-based Oral Rinse', 'chlorhexidine']","['PI, BOP and PD', 'PD', 'PI, PD, BOP', 'Peri-implant plaque index (PI) and bleeding-on-probing (BOP) and probing-depth (PD', 'PI and BOP', 'BOP']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",48.0,0.0257322,"In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up.","[{'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Alzoman', 'Affiliation': ''}, {'ForeName': 'Tariq Ghazi', 'Initials': 'TG', 'LastName': 'Alojaym', 'Affiliation': ''}, {'ForeName': 'Sandeepa Nuchilakath', 'Initials': 'SN', 'LastName': 'Chalikkandy', 'Affiliation': ''}, {'ForeName': 'Abid', 'Initials': 'A', 'LastName': 'Mehmood', 'Affiliation': ''}, {'ForeName': 'Fayza', 'Initials': 'F', 'LastName': 'Rashed', 'Affiliation': ''}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45069']
1836,32896184,"Remdesivir, a remedy or a ripple in severe COVID-19?","INTRODUCTION


In clinical trial for the Ebola virus, the broad-spectrum anti-viral agent remdesivir was shown to have a good safety profile. Remdesivir is now being tested in severe COVID-19.
AREAS COVERED


The Gilead Sciences SIMPLE trial suggests that the short-term use of remdesivir probably does not increase mortality dramatically or have serious short-term toxicity when used to treat severe COVID-19. The Adaptive COVID-19 treatment trials (ACTT1) trial showed that remdesivir may shorten recovery and decrease mortality in severe COVID-19 without increasing adverse effects.
EXPERT OPINION


It seems to me that we have learnt very little from the SIMPLE trial, and this would be predicted from a trial that has no control or placebo group. The results of ACTT1 were reported early after an interim analysis showed that a higher than expected number of recoveries had occurred. There was an indication that remdesivir may be reducing mortality, but this was no statistical significance. The trial is continuing, and the final data are eagerly awaited to determine whether remdesivir is a game-changing remedy or a ripple in the ongoing search for a medicine for the treatment of COVID-19.",2020,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155191,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1821645']
1837,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
1838,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
1839,32865375,Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.,"BACKGROUND


Despite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk.
METHODS


In this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation-related symptoms. The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated.
RESULTS


In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P = 0.005). The mean (±SD) number of nights spent in the hospital did not differ significantly between the groups (5.8±21.9 and 5.1±15.5 days per year, respectively; P = 0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups.
CONCLUSIONS


Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.).",2020,The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care.,"['patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either', 'patients with early atrial fibrillation and cardiovascular conditions', 'Patients with Atrial Fibrillation', 'In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization']","['early rhythm control or usual care', 'antiarrhythmic drugs or atrial fibrillation ablation']","['number of nights spent in the hospital per year', 'composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome', 'serious adverse events related to rhythm-control therapy', 'symptoms and left ventricular function', 'Symptoms and left ventricular function', 'mean (±SD) number of nights spent in the hospital', 'early rhythm control', 'composite of death, stroke, or serious adverse events related to rhythm-control therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",2789.0,0.143464,The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care.,"[{'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Brandes', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fetsch', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'van Gelder', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Laurent M', 'Initials': 'LM', 'LastName': 'Haegeli', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hamann', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'G Andre', 'Initials': 'GA', 'LastName': 'Ng', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Rekosz', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schoen', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schotten', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Suling', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Taggeselle', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Sakis', 'Initials': 'S', 'LastName': 'Themistoclakis', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Vardas', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Breithardt', 'Affiliation': ""From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019422']
1840,32865376,Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.,"BACKGROUND


The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.
METHODS


In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.
RESULTS


A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial.
CONCLUSIONS


Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).",2020,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","['for 3 months', '331 patients', 'patients who do not have an indication for long-term anticoagulation', '44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial', 'subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive', 'after Transcatheter Aortic-Valve Implantation']","['aspirin alone or aspirin plus clopidogrel', 'aspirin plus clopidogrel', 'aspirin alone', 'Aspirin with or without Clopidogrel', 'aspirin', 'transcatheter aortic-valve implantation (TAVI']","['incidence of bleeding and the composite of bleeding or thromboembolic events', 'all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding', 'bleeding and thromboembolic events', 'composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2', 'bleeding event', 'bleeding']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",331.0,0.493064,"Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005).","[{'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Nijenhuis', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Holvoet', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Christophe L F', 'Initials': 'CLF', 'LastName': 'Dubois', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Gert K', 'Initials': 'GK', 'LastName': 'van Houwelingen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan A S', 'Initials': 'JAS', 'LastName': 'Van Der Heyden', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Toušek', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Buysschaert', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roosen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Peper', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frederick W F', 'Initials': 'FWF', 'LastName': 'Thielen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Veenstra', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Dean R P P', 'Initials': 'DRPP', 'LastName': 'Chan Pin Yin', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Swaans', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Timmers', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa2017815']
1841,31829085,Can the fistula arm be used to lift heavy items? Six-pound dumbbells versus handgrip exercise in a 6-month follow-up secondary analysis of a randomized controlled trial.,"INTRODUCTION


Patients with arteriovenous fistulas are advised to avoid carrying heavy objects draped over the fistula arm. Awareness gradually leads to overprotection and a reduction in the use of the fistula arm. However, restricting motion in the fistula arm leads to decreased quality of life and diminished muscle strength. The current safety recommendations regarding lifting heavy items with the fistula arm are primarily based on experience. Few studies have provided evidence clarifying the scope of safe activity and the influence of load bearing on the continued patency of arteriovenous fistulas.
METHODS


This prospective observation was based on a long-term follow-up study in which 86 hemodialysis recipients with arteriovenous fistulas were randomized into either a dumbbell group or a handgrip group. The dumbbell group exercised with 6-lb dumbbells, while the handgrip group squeezed rubber balls. Postintervention primary patency and adverse events at the 6-month follow-up were analyzed.
RESULTS


No significant difference in postintervention primary patency was observed between the dumbbell group and the handgrip group at 6 months (97.4% vs 95.0%). There were two participants with high-flow fistulas in the dumbbell group and three in the handgrip group, with no significant difference between the two groups (5.3% vs 7.5%). In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
CONCLUSION


Hemodialysis patients can safely use their fistula arm to lift objects weighing less than 6 lb, which encourages increased motion and helps preserve the functionality of the fistula arm.",2020,"In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
","['86 hemodialysis recipients with arteriovenous fistulas', 'Patients with arteriovenous fistulas']","['dumbbell group exercised with 6-lb dumbbells, while the handgrip group squeezed rubber balls', 'handgrip group', 'Six-pound dumbbells versus handgrip exercise']","['high-flow fistulas', 'Postintervention primary patency and adverse events', 'quality of life and diminished muscle strength', 'postintervention primary patency', 'cardiac failure, aneurysm, puncture site hematoma, or hemorrhage']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C4760962', 'cui_str': 'Puncture site haematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",86.0,0.0195124,"In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
","[{'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Mo', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Jing-Ya', 'Initials': 'JY', 'LastName': 'Huang', 'Affiliation': 'Division of Nephrology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Sun', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li-Fang', 'Initials': 'LF', 'LastName': 'Zhou', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shu-Qian', 'Initials': 'SQ', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhuang', 'Affiliation': 'Department of Rehabilitation Medicine, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Ying-Gui', 'Initials': 'YG', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yuan-Han', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shuang-Xin', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xin-Ling', 'Initials': 'XL', 'LastName': 'Liang', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}]",The journal of vascular access,['10.1177/1129729819894090']
1842,32888230,Comparative effects of varenicline or combination nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt.,"BACKGROUND AND AIMS


The phase-based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre-cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C-NRT) relative to nicotine patch monotherapy on pre-cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators.
DESIGN


Secondary mediation analysis of data from the open-label, randomized Wisconsin Smokers' Health Study 2, a comparative effectiveness trial of varenicline or C-NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach.
SETTING


Research clinics in Madison and Milwaukee, Wisconsin, USA.
PARTICIPANTS


A total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6).
INTERVENTIONS


Twelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling.
MEASUREMENTS


The primary abstinence outcome was biochemically verified 7-day point-prevalence abstinence 4 weeks post-target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre-cessation phase) to 4 weeks after (cessation phase) the TQD.
FINDINGS


Pre-cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34-0.79], smoking expectancies (aOR = 0.46-0.79) and quitting motivation (aOR = 1.35-7.21) significantly predicted 4-week post-TQD abstinence (P < 0.05). Significant varenicline mediation occurred via greater suppression in pre-cessation craving [mediated effect (ab) = 0.09, standard error (SE) = 0.03, 95% confidence interval (CI) = 0.04-0.14] and smoking expectancies (ab = 0.06, SE = 0.02, 95% CI = 0.02-0.12). C-NRT mediation occurred via greater reduction in pre-post-TQD changes in craving (ab = 0.04, SE = 0.02, 95% CI = 0.01-0.08) and expectancies (ab = 0.03, SE = 0.02, 95% CI = 0.001-0.07), relative to patch monotherapy.
CONCLUSION


Among adult smokers seeking to quit, varenicline seems to work through its effects on suppression of craving and smoking expectancies pre-cessation while combination nicotine replacement therapy mediation seems to work through cessation-related reduction in craving and smoking expectancies changes.",2020,"Pre-cessation and cessation mean levels and slopes of craving (AOR=0.34-0.79), smoking expectancies (AOR=0.46-0.79), and quitting motivation (AOR=1.35-7.21) significantly predicted 4-week post-TQD abstinence (p<.05).","['Research clinics in Madison and Milwaukee, Wisconsin, USA.\nPARTICIPANTS\n\n\n1,051 daily smokers motivated to quit smoking (52.5% female; M age  =48.1, SD 11.6', 'adult smokers seeking to quit', 'adults who smoked, recruited via media and community outreach']","['Varenicline or Combination Nicotine', 'varenicline ', 'varenicline', 'nicotine patch monotherapy', 'combination nicotine patch and nicotine lozenge therapy (n=421), both compared with 12 weeks of patch control condition (n=230), with individual smoking cessation counseling', 'varenicline or C-NRT, versus patch monotherapy', 'varenicline and combination nicotine replacement therapy (C-NRT', 'Replacement Therapy versus Patch Monotherapy']","['smoking expectancies', '7-day point-prevalence abstinence 4 weeks post-target quit day (TQD', 'Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation', 'pre-cessation craving', 'Pre-cessation and cessation mean levels and slopes of craving', 'expectancies', 'quitting motivation']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1253423', 'cui_str': 'Nicotine Lozenges'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1051.0,0.0354541,"Pre-cessation and cessation mean levels and slopes of craving (AOR=0.34-0.79), smoking expectancies (AOR=0.46-0.79), and quitting motivation (AOR=1.35-7.21) significantly predicted 4-week post-TQD abstinence (p<.05).","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Treatment, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15248']
1843,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
1844,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
1845,32891212,"Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial.","BACKGROUND


There are no effective therapies for achondroplasia. An open-label study suggested that vosoritide administration might increase growth velocity in children with achondroplasia. This phase 3 trial was designed to further assess these preliminary findings.
METHODS


This randomised, double-blind, phase 3, placebo-controlled, multicentre trial compared once-daily subcutaneous administration of vosoritide with placebo in children with achondroplasia. The trial was done in hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK). Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment. Randomisation was done by means of a voice or web-response system, stratified according to sex and Tanner stage. Participants, investigators, and trial sponsor were masked to group assignment. Participants received either vosoritide 15·0 μg/kg or placebo, as allocated, for the duration of the 52-week treatment period administered by daily subcutaneous injections in their homes by trained caregivers. The primary endpoint was change from baseline in mean annualised growth velocity at 52 weeks in treated patients as compared with controls. All randomly assigned patients were included in the efficacy analyses (n=121). All patients who received one dose of vosoritide or placebo (n=121) were included in the safety analyses. The trial is complete and is registered, with EudraCT, number, 2015-003836-11.
FINDINGS


All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive placebo. Of 124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial. The adjusted mean difference in annualised growth velocity between patients in the vosoritide group and placebo group was 1·57 cm/year in favour of vosoritide (95% CI [1·22-1·93]; two-sided p<0·0001). A total of 119 patients had at least one adverse event; vosoritide group, 59 (98%), and placebo group, 60 (98%). None of the serious adverse events were considered to be treatment related and no deaths occurred.
INTERPRETATION


Vosoritide is an effective treatment to increase growth in children with achondroplasia. It is not known whether final adult height will be increased, or what the harms of long-term therapy might be.
FUNDING


BioMarin Pharmaceutical.",2020,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","['All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive', 'children with achondroplasia', 'hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK', '119 patients had at least one adverse event; vosoritide group, 59 (98%), and', 'Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment', '124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial']","['vosoritide with placebo', 'placebo', 'vosoritide or placebo', 'subcutaneous vosoritide therapy', 'vosoritide', 'vosoritide 15·0 μg/kg or placebo']","['annualised growth velocity', 'mean annualised growth velocity', 'growth velocity']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001080', 'cui_str': 'Achondroplasia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",121.0,0.793501,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Savarirayan', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, and University of Melbourne, Parkville, VIC, Australia. Electronic address: ravi.savarirayan@vcgs.org.au.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Tofts', 'Affiliation': ""Kids Rehab, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Irving', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, Evelina Children's Hospital, London, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilcox', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Bacino', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoover-Fong', 'Affiliation': 'McKusick-Nathans Department of Genetic Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Rosendo', 'Initials': 'R', 'LastName': 'Ullot Font', 'Affiliation': 'Hospital Sant Joan de Déu, Barcelona, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rutsch', 'Affiliation': ""Department of General Pediatrics, Muenster University Children's Hospital, Muenster, Germany.""}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Bober', 'Affiliation': 'Nemours-Alfred I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Lynda E', 'Initials': 'LE', 'LastName': 'Polgreen', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ginebreda', 'Affiliation': 'Hospital Universitario Quirón Dexeus, Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mohnike', 'Affiliation': 'Otto-von-Guericke-Universität, Magdeburg, Germany.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Charrow', 'Affiliation': ""Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hoernschmeyer', 'Affiliation': 'University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ozono', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Alanay', 'Affiliation': 'Acibadem Mehmet Ali Aydiniar University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Arundel', 'Affiliation': ""Sheffield Children's NHS Foundation Trust, Sheffield Children's Hospital, Sheffield, UK.""}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kagami', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Natsuo', 'Initials': 'N', 'LastName': 'Yasui', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Klane K', 'Initials': 'KK', 'LastName': 'White', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Saal', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Leiva-Gea', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Luna-González', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': ""Saitama Children's Hospital, Saitama, Japan.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Basel', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Dania M', 'Initials': 'DM', 'LastName': 'Porco', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Kala', 'Initials': 'K', 'LastName': 'Jayaram', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fisheleva', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Huntsman-Labed', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'BioMarin (UK), London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31541-5']
1846,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
1847,32891794,Evaluation of a 3-Dimensional-Printed Head Simulation Technique for Teaching Flexible Nasopharyngoscopy to Radiation Oncology Residents.,"PURPOSE


Simulation-based medical education is an effective tool for medical teaching, but simulation-based medical education deployment in radiation oncology (RO) is limited. Flexible nasopharyngoscopy (FNP), an essential skill for RO residents, requires practice that typically occurs on volunteer patients, introducing the potential for stress and discomfort. We sought to develop a high-fidelity simulator and intervention that provides RO residents the opportunity to develop FNP skills in a low-pressure environment.
METHODS AND MATERIALS


Computed tomography images were used to create an anatomically accurate 3-dimensional-printed model of the head and neck region. An intervention incorporating didactic instruction, multimedia content, and FNP practice on the model was designed and administered to RO residents attending the Anatomy and Radiology Contouring Bootcamp. Participants completed pre- and postintervention evaluations of the training session and model fidelity, and self-assessments of FNP skill and confidence performing FNP. Participants were video recorded performing FNP pre- and postintervention. Videos were scored by a blinded observer on a predefined rubric. Changes in scores were evaluated using the Wilcoxon signed-rank test.
RESULTS


Twenty-four participants from 17 institutions and 4 countries completed the intervention, 50% were women, and most were senior residents. Postintervention, FNP confidence and FNP performance improved significantly (mean ± standard deviation on a 10-point scale: 1.8 ± 1.8, P < .001; 2.2 ± 2.0, P < .001, respectively). Participants felt the model was helpful (mean ± standard deviation on a 5-point scale: 4.2 ± 0.6), anatomically correct (4.1 ± 0.9), and aided in spatial comprehension (4.3 ± 0.8). Overall satisfaction for the intervention was high (4.3 ± 0.8). Participants strongly agreed the intervention should be integrated into RO training programs (4.3 ± 0.8).
CONCLUSIONS


A 3-dimensional-printed model and associated intervention were effective at improving FNP performance and the teaching method was rated highly by participants. RO residents may benefit from broader dissemination of this technique to improve trainee performance.",2020,"Post-intervention, FNP confidence and FNP performance improved significantly (mean ± SD on a 10-point scale: 1.8 ± 1.8, p < 0.001; 2.2 ± 2.0, p < 0.001 respectively).","['Teaching Flexible Nasopharyngoscopy to Radiation Oncology Residents', 'Twenty-four participants from 17 institutions and 4 countries completed the intervention, 50% were female, and most were senior residents']","['Simulation-based medical education (SBME', 'Flexible nasopharyngoscopy (FNP']","['FNP confidence and FNP performance', 'Overall satisfaction intervention', 'FNP performance']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",50.0,0.0308012,"Post-intervention, FNP confidence and FNP performance improved significantly (mean ± SD on a 10-point scale: 1.8 ± 1.8, p < 0.001; 2.2 ± 2.0, p < 0.001 respectively).","[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Goodman', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Pautler', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Balestrini', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Cobos', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Eansor', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Jaswal', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Surrey, British Columbia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Manas', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiology, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Willmore', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Murrell', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Center, London, Ontario, Canada. Electronic address: David.Palma@lhsc.on.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.063']
1848,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
1849,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
1850,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
1851,32890855,Reading proficiency influences the effects of transcranial direct current stimulation: Evidence from selective modulation of dorsal and ventral pathways of reading in bilinguals.,"INTRODUCTION


tDCS can modulate reading which is processed by lexical (ventral) and sub-lexical (dorsal) pathways. Previous research indicates that pathway recruitment in bilinguals depends on a script's orthographic depth and a reader's proficiency with it. The effect of tDCS on each reading pathway has not been investigated in bilinguals. We stimulated the left dorsal and ventral pathways separately in Chinese-English (C-E) bilinguals to understand whether pathway-specific modulation by tDCS is possible and, if so, how it is influenced by orthographic depth and script proficiency.
METHODS


A double-blind, sham-controlled, within-subject experiment was designed wherein 16 balanced bilinguals received anodal tDCS in dorsal, ventral and sham sessions. Two tDCS montages of electrode sizes 5 × 5 cm 2  with 1) anode at CP5 and cathode at CZ, and 2) anode at TP7 and cathode at nape of the neck, were applied for stimulating the dorsal and ventral pathways respectively. Bilinguals were asked to read word lists for each language before and after stimulation. RTs for accurate trials were analysed using linear mixed-effect modelling that included proficiency scores for reading English pseudo-words (PW) and Chinese pinyin.
RESULTS


For both languages, word reading RTs were faster following dorsal pathway stimulation. The dorsal stimulation effect (change in RT) was negatively correlated with pseudoword reading and pinyin proficiency. Stimulation of the ventral pathway decreased RTs only for Chinese reading.
CONCLUSION


Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading. Dorsal pathway tDCS effects are modulated by sub-lexical reading proficiency.",2020,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,[],"['anodal tDCS', 'tDCS']",['dorsal stimulation effect (change in RT'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0476543,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,"[{'ForeName': 'Sagarika', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Centre for Research and Development in Learning (CRADLE), Singapore.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': ""O'Brien"", 'Affiliation': 'Centre for Research in Child Development (CRCD), National Institute of Education, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCloskey', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Desmond', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States. Electronic address: brapp1@jhu.edu.'}, {'ForeName': 'S H Annabel', 'Initials': 'SHA', 'LastName': 'Chen', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore; Centre for Research and Development in Learning (CRADLE), Singapore; Lee Kong Chian School of Medicine (LKC Medicine), Nanyang Technological University, Singapore. Electronic address: annabelchen@ntu.edu.sg.'}]",Brain and language,['10.1016/j.bandl.2020.104850']
1852,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
1853,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
1854,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
1855,32910717,"IL-2  and  IL-2R  gene polymorphisms and immune function in people residing in areas with high background radiation, Yangjiang, China.","PURPOSE


Long-term exposure to low dose radiation may trigger immune response and stimulate hormesis. Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R ) play a crucial role in immune function. We aimed to explore the possible association of  IL-2  and  IL-2R  gene polymorphisms with low dose radiation exposure, as well as the relationship with  IL-2  gene expression in people residing in areas with a high background radiation in Yangjiang, China.
MATERIALS AND METHODS


We recruited and assigned 54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group. All the participants wore a thermoluminescent dosimeter (TLD) for 90 days, and answered questionnaires. The serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of  IL2RA ,  IL2RB ,  IL2RG , and  IL2  were also analyzed. Additionally, we tested 10 polymorphic loci associated with the  IL-2  gene.
RESULTS


The annual effective radiation doses in the HNBR and CA groups were 6.24 mSv y -1  and 1.95 mSv y -1 , respectively. After adjusting for potential confounding factors, the serum levels of  IL-2  and  IL-5  were higher in the HNBR group than the CA group ( p  < .05), while the serum level of  TGFβ  was lower in the HNBR group ( p  < .05). The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < .05). The  IL-2RB  rs76206423 AA allele showed significant variations in the HNBR group ( p  = .0381).
CONCLUSIONS


Long-term exposure to low dose radiation may enhance immune function, and  IL-2RB  rs76206423 may be related to the expression of  IL-2  by other coding variants. Moreover, our data provide a better understanding of the molecular mechanism of the immune response to low dose radiation.",2020,The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < 0.05).,"['people residing in areas with a high background radiation in Yangjiang, China', '54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group', 'people residing in areas with high background radiation, Yangjiang, China']",['Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R '],"['IL-2  gene mRNA expression level', 'serum levels of  IL-2  and  IL-5', 'serum level of  TGFβ', 'serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of  IL2RA ,  IL2RB ,  IL2RG , and  IL2']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004607', 'cui_str': 'Background radiation'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C1700887', 'cui_str': 'IL2RA protein, human'}, {'cui': 'C1259013', 'cui_str': 'IL2RB protein, human'}, {'cui': 'C1568975', 'cui_str': 'IL2RG protein, human'}]",54.0,0.0344582,The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < 0.05).,"[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cuiju', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Shibiao', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Ying', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Rongzong', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Haijuan', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huifeng', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Tianjian', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}]",International journal of radiation biology,['10.1080/09553002.2020.1820607']
1856,32910720,Predicting Response to Vocabulary Intervention Using Dynamic Assessment.,"Purpose The purpose of this study was to examine how well students' response to a morphological vocabulary intervention can be predicted before the start of the intervention from traditional static assessments and to determine whether a dynamic assessment with graduated prompts improves the prediction. Method A planned secondary analysis of a randomized trial of a morphological vocabulary intervention for fifth-grade students with limited vocabulary was conducted. Response to this intervention was examined for 111 participants based on their development in definitions of morphologically transparent words from pretest to posttest. Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis as well as a dynamic assessment of morphological analysis were evaluated as predictors of students' response to intervention. Results The static pretest measures predicted more than half of the overall variance in students' response to intervention and provided a good classification of students with subsequent poor or good response to intervention. The single best static predictor was the static assessment of morphological analysis. Furthermore, the dynamic assessment added significantly to the prediction of the overall variance in students' response to intervention and to the correct early classification of students as poor or good responders. Conclusions The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures. This study also provides evidence for the added predictive value of a dynamic assessment of morphological analysis.",2020,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"['111 participants based on their development in definitions of morphologically transparent words from pretest to posttest', 'fifth-grade students with limited vocabulary was conducted']",['morphological vocabulary intervention'],"['Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",111.0,0.0206373,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"[{'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Gellert', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Arnbak', 'Affiliation': 'Danish School of Education, Aarhus University, Denmark.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-20-00045']
1857,32905977,A preliminary study on the application of DTI in the treatment of brain tumors in motor function areas with gamma knife.,"OBJECTIVES


The treatment safety and efficiency as well as the life quality of patients are still main concerns in gamma knife radiosurgery. In this study, the feasibility of applying diffusion tensor imaging (DTI) in gamma knife radiosurgery for the treatment of brain tumor in motor function areas was investigated, which aims to provide protection on the pyramidal tract and preserve the motor function in patients.
PATIENTS AND METHODS


Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group. The tumor control rate was assessed at 3 months after surgery. The muscle strength of affected limb, KPS scores, ZEW scores and complications were evaluated at 3 and 6 months after gamma knife radiosurgery.
RESULTS


Our results indicated that the tumor control rate, complication rate, the muscle strength of affected limb and KPS scores were not significantly different between the two groups at 3 months after surgery. At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group. Furthermore, the stability of muscle strength in patients with limb dysfunction was significantly improved in DTI group (86.4 % vs 50 %, P = 0.028).
CONCLUSION


In summary, the application of DTI in gamma knife radiosurgery for the treatment of brain tumors in motor function areas can precisely define the tumor edge from pyramidal tract, which will support on designing individual treatment plan, reducing the incidence of complications, and improving long-term life quality in patients.",2020,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","['Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group', 'patients', 'brain tumors in motor function areas with gamma knife']","['DTI', 'diffusion tensor imaging (DTI', 'gamma knife radiosurgery']","['tumor control rate', 'ZEW scores', 'limb dysfunction', 'tumor control rate, complication rate, the muscle strength of affected limb and KPS scores', 'complication rate', 'KPS scores', 'muscle strength of affected limb, KPS scores, ZEW scores and complications', 'stability of muscle strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",74.0,0.018093,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","[{'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China. Electronic address: hongweiwangimmu@yahoo.com.'}, {'ForeName': 'Zhanbiao', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Magnetic Resonance Imaging, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Guorong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106169']
1858,32886935,Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study.,"BACKGROUND


Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration.
METHODS


68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates.
RESULTS


The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %;  P  = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217];  P  = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups.
CONCLUSIONS


Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.",2020,"During follow-up, the mean stent patency was significantly longer in the FCSEMS with internal anchoring plastic stent group (181 [95% CI 159-203] vs. 119 [95% CI 94-143] days, p = 0.01).","['malignant distal biliary strictures', 'malignant distal biliary obstruction', 'Sixty-eight patients with unresectable malignant distal biliary obstruction']","['internal anchoring plastic stent', 'self-expandable metal stents (SEMS', 'FCSEMS', 'FCSEMS with internal anchoring plastic stent']","['rate of stent migration', 'stent-related adverse events, stent patency, and survival rates', 'mean stent patency', 'stent-related adverse events and overall survival rates']","[{'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}]","[{'cui': 'C4087543', 'cui_str': 'Stent migration'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",68.0,0.357274,"During follow-up, the mean stent patency was significantly longer in the FCSEMS with internal anchoring plastic stent group (181 [95% CI 159-203] vs. 119 [95% CI 94-143] days, p = 0.01).","[{'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Paik', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Myung', 'Initials': 'SM', 'LastName': 'Woo', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Byeong Jun', 'Initials': 'BJ', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Myongji Hospital, Goyang, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Dong-Won', 'Initials': 'DW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.'}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Ji Kon', 'Initials': 'JK', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Endoscopy,['10.1055/a-1256-0571']
1859,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
1860,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
1861,32891709,Influence of n-acetylcysteine maintenance on the pharmacodynamic effects of oral ethanol.,"RATIONALE


Glutamate systems play an important role in the abuse related effects of alcohol. n-Acetylcysteine, a drug that promotes glutamate homeostasis, attenuates a range of alcohol effects in preclinical models.
OBJECTIVES


This human laboratory study determined the influence of n-acetylcysteine maintenance on alcohol self-administration using a model predictive of treatment effectiveness, along with the subjective, performance and physiological effects of alcohol. We hypothesized that n-acetylcysteine would attenuate alcohol self-administration, as well as positive subjective effects of alcohol.
METHODS


Nine subjects with alcohol use disorder completed this within-subjects study. Subjects were maintained on placebo, 1.2 and 2.4 g n-acetylcysteine in random order on an outpatient basis. After five days of maintenance on the target dose, subjects completed overnight inpatient experimental sessions in which the pharmacodynamic effects of alcohol were determined.
RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink). n-Acetylcysteine did not alter the effects of alcohol.
CONCLUSIONS


These results indicate that although n-acetylcysteine can safely be combined with alcohol, it does not attenuate the abuse related effects of alcohol and is unlikely to be an effective standalone alcohol use disorder treatment. However, considering study limitations, future work is needed to further understand whether and how n-acetylcysteine might be used as a treatment for alcohol use disorder (e.g., in combination with a behavioral treatment or another pharmacological agent).",2020,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).",['Nine subjects with alcohol use disorder completed this within-subjects study'],"['placebo', 'oral ethanol']","['breath alcohol concentration, increased ratings of Feel Drink']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",9.0,0.012153,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA. Electronic address: william.stoops@uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Lon R', 'Initials': 'LR', 'LastName': 'Hays', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Abner O', 'Initials': 'AO', 'LastName': 'Rayapati', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173037']
1862,32890647,Fusion Imaging with a Mobile C-Arm for Peripheral Arterial Disease.,"BACKGROUND


Fusion imaging makes it possible to improve endovascular procedures and is mainly used in hybrid rooms for aortic procedures. The objective of this study was to evaluate the feasibility of fusion imaging for femoropopliteal endovascular procedures with a mobile flat plane sensor and dedicated software to assist endovascular navigation.
MATERIALS AND METHODS


Between May and December 2017, 41 patients requiring femoropopliteal endovascular revascularization were included. Interventions were carried out in a conventional surgical room equipped with a mobile plane sensor (Cios Alpha, Siemens). The numerical video stream was transmitted to an angionavigation station (EndoNaut (EN), Therenva). The software created an osseous and arterial panorama of the treated limb from the angiographies carried out at the beginning of procedure. After each displacement of the table, the software relocated the current image on the osseous panorama, with 2D-2D resetting, and amalgamated the mask of the arterial panorama. The success rates of creation of osseous and arterial panorama and the success of relocation were evaluated. The data concerning irradiation, the volume of contrast (VC) injected, and operative times were recorded.
RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%). About 35 relocations based on a 2D-2D resetting could be obtained in the 41 procedures, with a success rate of 85%. The causes of failure were a change in table height or arch angulation. The average duration of intervention was 74.5 min. The irradiation parameters were duration of fluoroscopy 17.8 ± 13.1 min, air kerma 80.5 ± 68.4 mGy, and dose area product 2140 ± 1599 μGy m 2 . The average VC was 24.5 ± 14 mL.
CONCLUSIONS


This preliminary study showed that fusion imaging is possible in a nonhybrid room for peripheral procedures. Imagery of mobile C-arms can be improved for femoropopliteal endovascular procedures without heavy equipment. These imagery tools bring an operative comfort and could probably reduce irradiation and the injected VC. The clinical benefit must be evaluated in more patients in a randomized comparative study with a rigorous methodology.",2020,"RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%).",['41 patients requiring femoro-popliteal endovascular revascularization were included'],[],"['average volume of contrast (VC', 'success rates of creation of osseous and arterial panorama and the success of relocation', 'average duration of intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0338013,"RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Lalys', 'Affiliation': 'Therenva, Rennes, France.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Saudreau', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Pascot', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Barré', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France; INSERM, U1099, Rennes, France; Signal and Image Processing Laboratory (LTSI), University of Rennes 1, Rennes, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Kaladji', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, Rennes, France; INSERM, U1099, Rennes, France; Signal and Image Processing Laboratory (LTSI), University of Rennes 1, Rennes, France. Electronic address: adrien.kaladji@chu-rennes.fr.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.07.059']
1863,32896292,Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial.,"BACKGROUND


The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.
METHODS


We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278.
FINDINGS


447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
INTERPRETATION


In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.
FUNDING


COALITION COVID-19 Brazil and EMS.",2020,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","['patients with severe COVID-19', '57 centres in Brazil', '447 patients were enrolled from March 28 to May 19, 2020', '397 patients who constituted the mITT population', 'enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of', 'patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II', 'population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation ', 'patients admitted to the hospital with severe COVID-19']","['hydroxychloroquine', 'azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides', 'oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation', 'azithromycin', 'Azithromycin', 'invasive mechanical ventilation']","['intention-to-treat (ITT', 'Safety', 'Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",447.0,0.343065,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração, Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: otavio.berwanger@einstein.br.'}, {'ForeName': 'Henrique A', 'Initials': 'HA', 'LastName': 'Fonseca', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Thiago D', 'Initials': 'TD', 'LastName': 'Corrêa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Ferraz', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Maura G', 'Initials': 'MG', 'LastName': 'Lapa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Sírio Libanês Research and Education Institute, São Paulo, Brazil.'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil; Duke University Medical Centre, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Airton L O', 'Initials': 'ALO', 'LastName': 'Manoel', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Felipe M T', 'Initials': 'FMT', 'LastName': 'Piza', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Martins', 'Affiliation': 'Hospital Estadual Jayme dos Santos Neves, Serra, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Hospital de Clínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Guilherme B', 'Initials': 'GB', 'LastName': 'Olivato', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'Hospital Giselda Trigueiro, Natal, Brazil.'}, {'ForeName': 'Otavio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'Hospital Santa Paula, São Paulo, Brazil.'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Monalisa B', 'Initials': 'MB', 'LastName': 'Oliveira', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Ronaldo V P', 'Initials': 'RVP', 'LastName': 'Soares', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Diogo D F', 'Initials': 'DDF', 'LastName': 'Moia', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luciana P A', 'Initials': 'LPA', 'LastName': 'Piano', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Kleber', 'Initials': 'K', 'LastName': 'Castilho', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Roberta G R A P', 'Initials': 'RGRAP', 'LastName': 'Momesso', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Guilherme P P', 'Initials': 'GPP', 'LastName': 'Schettino', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luiz Vicente', 'Initials': 'LV', 'LastName': 'Rizzo', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Ary Serpa', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Department of Anesthesiology, Pain and Intensive Care Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31862-6']
1864,32897117,Re: Effect of Intensive vs Standard Blood Pressure Treatment upon Erectile Function in Hypertensive Men: Findings from the Systolic Blood Pressure Intervention Trial.,,2020,,['Hypertensive Men'],['Intensive vs Standard Blood Pressure Treatment'],[],"[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0373286,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001252.03']
1865,32897125,Re: Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,,2020,,[],['Resident Physician Schedule without 24-Hour Shifts'],[],[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0332029,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001256.01']
1866,32897150,Re: Randomized Study of Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-Year Postbiopsy Follow-Up.,,2020,,['Men on Active Surveillance (ASIST'],['Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0661264,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001261.02']
1867,32897182,Early Mobilization Versus Splinting After Surgical Management of Distal Radius Fractures.,"BACKGROUND


After the surgical management of distal radius fractures (DRF) in older patients, further treatment with a splint often follows. It is unclear whether early mobilization might be superior to splinting in this group of patients, as it is in others. In this prospective, randomized, controlled trial, we attempted to determine whether early mobilization yields better outcomes.
METHODS


50 patients over age 70 with DRF were included in the trial. Group A (the splint group) was treated with postoperative immobilization, group B with early mobilization. Clinical follow-up examinations were performed at 2, 6, and 12 weeks and at 6 and 12 months. X-rays were obtained preoperatively, postoperatively, at 6 weeks, and at 6 months. The primary outcome parameter was the modified Mayo Wrist Score (MMWS) at 6 weeks.
RESULTS


At 6 weeks, the functional outcome was better to a statistically significant extent in group B (MMWS; 65/100 vs. 55/100 [q25 : 55/40 - q75 : 70/70; p = 0.025]). No difference between the two groups was demonstrable in their further clinical course. The estimated regression model revealed a statistically significant effect of the method of treatment (p = 0.023). There were no differences in hand strength or in x-ray findings.
DISCUSION


Early mobilization is associated with better wrist function on initial follow-up, without any demonstrable disadvantage with respect to secondary dislocation. The psychological benefit and protective function of wrist splinting in patients who are in danger of falling should nonetheless be investigated in further studies.",2020,"There were no differences in hand strength or in x-ray findings.
","['Distal Radius Fractures', 'older patients', '50 patients over age 70 with DRF were included in the trial']","['postoperative immobilization, group B with early mobilization', 'Early Mobilization Versus Splinting']","['hand strength', 'functional outcome', 'modified Mayo Wrist Score (MMWS']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0354781,"There were no differences in hand strength or in x-ray findings.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zeckey', 'Affiliation': 'Department of Trauma and Reconstructive Surgery, University Hospital Munich, Ludwig-Maximilians-Universität München; Department of Trauma Surgery and Orthopedics, RoMed Klinikum Rosenheim; Statistical Consulting Unit StaBLab, Department of Statistics, Ludwig-Maximilians-Universität München.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Späth', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kieslich', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kammerlander', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Weigert', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Neuerburg', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0445']
1868,32897665,Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial.,"OBJECTIVES


Electrical muscle stimulation is widely used to enhance lower limb mobilization. Although upper limb muscle atrophy is common in critically ill patients, electrical muscle stimulation application for the upper limbs has been rarely reported. The purpose of this study was to investigate whether electrical muscle stimulation prevents upper and lower limb muscle atrophy and improves physical function.
DESIGN


Randomized controlled trial.
SETTING


Two-center, mixed medical/surgical ICU.
PATIENTS


Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days.
INTERVENTIONS


Forty-two patients were randomly assigned to the electrical muscle stimulation (n = 17) or control group (n = 19).
MEASUREMENTS AND MAIN RESULTS


Primary outcomes were change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5. Secondary outcomes included occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels. The change in biceps brachii muscle thickness was -1.9% versus -11.2% in the electrical muscle stimulation and control (p = 0.007) groups, and the change in cross-sectional area was -2.7% versus -10.0% (p = 0.03). The change in rectus femoris muscle thickness was -0.9% versus -14.7% (p = 0.003) and cross-sectional area was -1.7% versus -10.4% (p = 0.04). No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups. The length of hospitalization was shorter in the electrical muscle stimulation group (23 d [19-34 d] vs 40 d [26-64 d]) (p = 0.04). On day 3, the change in the branched-chain amino acid level was lower in the electrical muscle stimulation group (40.5% vs 71.5%; p = 0.04).
CONCLUSIONS


In critically ill patients, electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis and decreased the length of hospitalization.",2020,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"['Two-center, mixed medical/surgical ICU', 'Critically Ill Patients', 'Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days']","['Electrical Muscle Stimulation', 'electrical muscle stimulation']","['cross-sectional area', 'electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis', 'biceps brachii muscle thickness', 'ICU-acquired weakness', 'length of hospitalization', 'branched-chain amino acid level', 'occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels', 'change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5', 'change in rectus femoris muscle thickness', 'ICU mobility scale']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1513053', 'cui_str': 'Medical Surgical Nursing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",42.0,0.0549303,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"[{'ForeName': 'Nobuto', 'Initials': 'N', 'LastName': 'Nakanishi', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Oto', 'Affiliation': 'Emergency and Disaster Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Yoshitoyo', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Nakataki', 'Affiliation': 'Intensive Care Medicine, Tokushima Prefectural Central Hospital, Tokushima, Japan.'}, {'ForeName': 'Taiga', 'Initials': 'T', 'LastName': 'Itagaki', 'Affiliation': 'Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': 'Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Intensive Care Medicine, Tokushima Prefectural Central Hospital, Tokushima, Japan.'}]",Critical care medicine,['10.1097/CCM.0000000000004522']
1869,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
1870,32898699,N-Glycome changes reflecting resistance to platinum-based chemotherapy in ovarian cancer.,"A number of studies have reported aberrant glycosylation in connection with malignancy. Our investigation further expands on this topic through the examination of N-glycans, which could be associated with the resistance of advanced stage, high-grade non-mucinous ovarian cancer to platinum/taxane based chemotherapy. We used tissue samples of 83 ovarian cancer patients, randomly divided into two independent cohorts (basic and validation). Both groups involved either cases with/without postoperative tumor residue or the cases determined either resistant or sensitive to this chemotherapy. In the validation cohort, preoperative serum samples were also available. N-glycans released from tumors and sera were permethylated and analyzed by matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS). The MS analysis yielded a consecutive detection of 68 (tissue) and 63 (serum) N-glycan spectral signals. Eight of these were found to be differentially abundant in tissues of both independent cohorts including the cases with a postoperative cancer residue. One of these glycans was detected as differentially abundant in sera of the validation cohort. No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort. From the biochemical point of view, the statistically significant N-glycans correspond to the structures carrying bisecting (terminal) GlcNAc residue and tetra-antennary structures with sialic acid and/or fucose residues. Among them, six tissue N-glycans could be considered potential markers connected with a resistance to chemotherapy in ovarian cancer patients. The prediction of primary resistance to standard chemotherapy may identify the group of patients suitable for alternative treatment strategies. SIGNIFICANCE: Drug resistance has become a major impediment to a successful treatment of patients with advanced ovarian cancer. The glycomic measurements related to cancer are becoming increasingly popular in identification of the key molecules as potential diagnostic and prognostic indicators. Our report deals with identification of differences in N-glycosylation of proteins in tissue and serum samples from the individuals showing sensitivity or resistance to platinum/taxane-based chemotherapy. The detection sensitivity to chemotherapy is vitally important for these patients.",2020,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"['patients with advanced ovarian cancer', 'ovarian cancer', '83 ovarian cancer patients', 'ovarian cancer patients']","['platinum/taxane-based chemotherapy', 'platinum-based chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],83.0,0.0192624,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zahradnikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ihnatova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Recetox, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Lattova', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Uhrik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Eliska', 'Initials': 'E', 'LastName': 'Stuchlikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Nenutil', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Nalezinska', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Chovanec', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Zdrahal', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Borivoj', 'Initials': 'B', 'LastName': 'Vojtesek', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Hernychova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic. Electronic address: lenka.hernychova@mou.cz.'}, {'ForeName': 'Milos V', 'Initials': 'MV', 'LastName': 'Novotny', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Department of Chemistry, Indiana University, 800 E. Kirkwood Avenue, Bloomington, IN 47405, USA. Electronic address: novotny@indiana.edu.'}]",Journal of proteomics,['10.1016/j.jprot.2020.103964']
1871,32901299,Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy regarding incidence of delayed gastric emptying after pancreaticoduodenectomy.,"PURPOSE


Delayed gastric emptying (DGE) is an important postoperative complication after pancreaticoduodenectomy (PD), and its incidence may be associated with the utilized surgical procedures. Compared with pancreaticojejunostomy (PJ) after PD, it may be speculated that pancreaticogastrostomy (PG) is a risk factor for DGE, because it needs an anastomosis of the remnant pancreas to the back wall of the stomach. This study aimed to compare PG and PJ with regard to the incidence of DGE after PD.
METHODS


We performed a prospective open-label randomized clinical trial (RCT) including patients undergoing elective pancreaticoduodenectomy, who were randomly assigned PG or PJ the day before surgery. The primary endpoint was incidence of DGE.
RESULTS


The study included 60 patients (30 PG, 30 PJ), of whom seven were deemed unresectable, one was enucleated, and one was switched from PJ to PG during surgery according to the surgeon's decision. Thus, modified intention-to-treat analyses were performed in 27 PG patients and 26 PJ patients. DGE occurred in three patients in the PG group and six patients in the PJ group, which did not constitute a significant between-group difference (P = 0.42). In the PG group, two cases were ISGPS grade A DGE and one was grade C. In the PJ group, one case was grade A, two grade B, and three grade C. The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
CONCLUSIONS


Post-PD DGE incidences were similar after PG and PJ.",2020,"The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
","['27 PG patients and 26 PJ patients', 'patients undergoing elective pancreaticoduodenectomy, who were randomly assigned PG or PJ the day before surgery', ""60 patients (30 PG, 30 PJ), of whom seven were deemed unresectable, one was enucleated, and one was switched from PJ to PG during surgery according to the surgeon's decision""]","['pancreaticojejunostomy (PJ', 'pancreaticogastrostomy versus pancreaticojejunostomy']","['incidence of DGE', 'incidence of other morbidities or postoperative hospital stay', 'ISGPS grade', 'delayed gastric emptying', 'DGE']","[{'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",60.0,0.118862,"The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. heguchi@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Iwagami', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Tomimaru', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Akita', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Kunihito', 'Initials': 'K', 'LastName': 'Gotoh', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nagano', 'Affiliation': 'Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group, Osaka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01982-0']
1872,32902391,Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial.,"BACKGROUND


Adults with type 2 diabetes may experience health benefits, including glycemic control and weight loss, from following a very low-carbohydrate, ketogenic (VLC) diet. However, it is unclear which ancillary strategies may enhance these effects.
OBJECTIVE


This pilot study aims to estimate the effect sizes of 3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring) that may improve outcomes of a 12-month web-based ad libitum VLC diet and lifestyle intervention for adults with type 2 diabetes. The primary intervention also included other components to improve adherence and well-being, including positive affect and mindfulness as well as coaching.
METHODS


Overweight or obese adults (n=44; BMI 25-45 kg/m 2 ) with type 2 diabetes (glycated hemoglobin [HbA 1c ] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention. Using a 2×2×2 randomized factorial design, we compared 3 enhancement strategies: (1) near-daily text messages about the intervention's recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring (urine n=21 vs breath n=23). We assessed HbA 1c  and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA 1c  and weight at 12 months against an a priori threshold of Cohen d of 0.5 or greater.
RESULTS


We retained 73% (32/44) of the participants at 12 months. The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up. In intent-to-treat (ITT) analyses, the mean HbA 1c  reduction was 1.0% (SD 1.6) and the mean weight reduction was 5.3% (SD 6.0), whereas among study completers, these reductions were 1.2% (SD 1.7) and 6.3% (SD 6.4), respectively, all with a P value of less than .001. In ITT analyses, no enhancement strategy met the effect size threshold. Considering only study completers, 2 strategies showed a differential effect size of at least a d value of 0.5 or greater.
CONCLUSIONS


Text messages, gifts of food and cookbooks, and urine-based ketone self-monitoring may potentially enhance the glycemic or weight loss benefits of a web-based VLC diet and lifestyle intervention for individuals with type 2 diabetes. Future research could investigate other enhancement strategies to help create even more effective solutions for the treatment of type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648.",2020,"The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up.","['Adults With Type', 'individuals with type 2 diabetes', 'Adults with type 2 diabetes', 'Overweight or obese adults (n=44; BMI 25-45 kg/m 2 ) with type 2 diabetes (glycated hemoglobin [HbA 1c ] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention', 'adults with type 2 diabetes']","[""enhancement strategies: (1) near-daily text messages about the intervention's recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring"", 'VLC diet and lifestyle intervention', '3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring', 'libitum VLC diet and lifestyle intervention']","['adherence and well-being, including positive affect and mindfulness as well as coaching', 'glucose control and reductions in body weight', 'mean weight reduction', 'mean HbA 1c  reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376294', 'cui_str': 'Cookbooks'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.0757783,"The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up.","[{'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Saslow', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Judith Tedlie', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Northwestern Medicine, Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'Department of Health Education, San Francisco State University, San Francisco, CA, United States.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Liestenfeltz', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Missel', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Hovig', 'Initials': 'H', 'LastName': 'Bayandorian', 'Affiliation': ''}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Aikens', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}]",JMIR diabetes,['10.2196/15835']
1873,32902644,Exercise Training Reduces Inflammation of Adipose Tissue in the Elderly: Cross-Sectional and Randomized Interventional Trial.,"CONTEXT


Metabolic disturbances and a pro-inflammatory state associated with aging and obesity may be mitigated by physical activity or nutrition interventions.
OBJECTIVE


The aim of this study is to assess whether physical fitness/exercise training (ET) alleviates inflammation in adipose tissue (AT), particularly in combination with omega-3 supplementation, and whether changes in AT induced by ET can contribute to an improvement of insulin sensitivity and metabolic health in the elderly.
DESIGN, PARTICIPANTS, MAIN OUTCOME MEASURES


The effect of physical fitness was determined in cross-sectional comparison of physically active/physically fit (trained) and sedentary/less physically fit (untrained) older women (71 ± 4 years, n = 48); and in double-blind randomized intervention by 4 months of ET with or without omega-3 (Calanus oil) supplementation (n = 55). Physical fitness was evaluated by spiroergometry (maximum graded exercise test) and senior fitness tests. Insulin sensitivity was measured by hyperinsulinemic-euglycemic clamp. Samples of subcutaneous AT were used to analyze mRNA gene expression, cytokine secretion, and immune cell populations.
RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages, and higher relative content of γδT-cells in AT when compared with untrained women. Similar effects were recapitulated in response to a 4-month ET intervention. Content of CD36+ cells, γδT-cells, and mRNA expression of several inflammatory and oxidative stress markers correlated to insulin sensitivity and cardiorespiratory fitness.
CONCLUSIONS


In older women, physical fitness is associated with less inflammation in AT. This may contribute to beneficial metabolic outcomes achieved by ET. When combined with ET, omega-3 supplementation had no additional beneficial effects on AT inflammatory characteristics.",2020,"RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages and higher relative content of γδT-cells in AT when compared to Untrained women.","['Trained and Untrained older women (71±4 years, n=48', 'adipose tissue in the elderly']","['physical fitness/exercise training (ET', 'ET with or without omega-3 (Calanus oil) supplementation', 'Exercise training', 'ET, omega-3 supplementation']","['Physical fitness', 'lower mRNA levels of inflammation and oxidative stress markers', 'Content of CD36+ cells, γδT-cells and mRNA expression of several inflammatory and oxidative-stress markers', 'physical fitness', 'insulin sensitivity (IS) and metabolic health']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0381537,"RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages and higher relative content of γδT-cells in AT when compared to Untrained women.","[{'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Čížková', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Štěpán', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Klára', 'Initials': 'K', 'LastName': 'Daďová', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Ondrůjová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sontáková', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krauzová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Matouš', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Koc', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gojda', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kračmerová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Štich', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rossmeislová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Šiklová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa630']
1874,32809224,Pediatric randomized trial EORTC CLG 58951: Outcome for adolescent population with acute lymphoblastic leukemia.,"Over the years, the prognosis of adolescents treated for acute lymphoblastic leukemia (ALL) has improved. However, this age group still represents a challenge with an overall survival (OS) of 60% compared to 85% in younger children. Herein, we report the outcome of adolescents treated in the European Organisation for Research and Treatment of Cancer (EORTC) 58951 clinical trial. EORTC 58951 clinical trial included patients with de novo ALL between 1998 and 2008. For this study, we analyzed data of all adolescents between 15 and under 18. Data from 97 adolescents were analyzed, 70 had B-lineage and 27 had T-lineage ALL. The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively. For the T-lineage, the 8-year EFS and OS were 57.4% (36.1%-74.0%) and 59.0% (36.1%-76.2%), respectively. ""B-other"" ALL, defined as BCP-ALL lacking any known recurrent genetic abnormalities were more frequent in our adolescent population (52.8%) than in younger children (27.1%). Outcome of adolescents in the EORTC 58951 study is supporting the findings that adolescents have better outcome in pediatric compared to adults' trials. Nevertheless, in pediatric studies, adolescents still have a worse prognosis than younger children. Despite the fact that specific unfavorable characteristics may be linked to the adolescent population, a careful study and characterization of adolescents ""B-other"" genetic abnormalities in ALL is critical to improve the outcome of this population.",2020,"The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively.","['all adolescents between 15 and under 18', 'patients with de novo', 'adolescent population with acute lymphoblastic leukemia', '97 adolescents were analyzed, 70 had B-lineage and 27 had T-lineage ALL', 'adolescents treated in the European Organisation for Research and Treatment of Cancer (EORTC) 58951 clinical trial']",[],"['8-year EFS and OS', 'overall survival (OS', '8-year event-free survival (EFS) and OS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",97.0,0.0882408,"The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Olivier-Gougenheim', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Arfeuille', 'Affiliation': 'Department of Genetic Biochemistry, Robert-Debré Hospital, AP-HP and University of Paris-Diderot, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organization for Research and Treatment of Cancer (EORTC), EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sirvent', 'Affiliation': ""Department of Pediatric and Adolescent Hematology-Oncology, Arnaud de Villeneuve Children's Hospital, Montpellier, France.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Plat', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': 'Department of Hematology-Oncology, Reine Fabiola Children Hospital, Brussels, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'de Moerloose', 'Affiliation': 'Department of Pediatric Hematology-Oncology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Domenech', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': 'Department of Pediatric Hematology-Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Pierre-Simon', 'Initials': 'PS', 'LastName': 'Rohrlich', 'Affiliation': 'Department of Pediatric Hematology, Archet University Hospital, Nice, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Cavé', 'Affiliation': 'Department of Genetic Biochemistry, Robert-Debré Hospital, AP-HP and University of Paris-Diderot, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bertrand', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}]",Hematological oncology,['10.1002/hon.2791']
1875,32895660,Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer.,"PURPOSE


Oral mucositis (OM) is the most frequent side effect of radiation. Selenium deficiency leads to increased levels of free oxygen radicals and the selenium level tends to fall during radiotherapy. Hence, in this double-blind randomised controlled clinical trial, the effect of selenium was assessed in patients receiving radiation.
MATERIALS AND METHODS


Patients with head and neck cancer who were candidates to receive radiation were instructed to use selenium 200 mcg tablets twice daily. The grade of OM was evaluated by the World Health Organization (WHO) grading system on a weekly basis. The selenium level was measured at baseline and at the end of the radiation.
RESULTS


Seventy-one patients with head and neck cancer (37 in the selenium group, 34 in the placebo group) were enrolled in the study. The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24) Conclusion: Selenium supplementation does not appear to affect the selenium level as well as the severity and duration of OM. It is supposed that higher doses may be effective in the prevention of RT-mucositis. This trial was registered in the Iranian Registry of Clinical Trials accessible at www.irct.ir (ID No. IRCT2014072718612N1).",2020,"The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24)","['patients receiving radiation', 'Seventy-one patients with head and neck cancer (37 in the selenium group, 34 in the placebo group) were enrolled in the study', 'Patients with Head and Neck Cancer', 'Patients with head and neck cancer who were candidates to receive radiation']","['Selenium supplementation', 'selenium 200 mcg tablets twice daily', 'Selenium', 'placebo', 'selenium']","['cumulative incidence of OM', 'grade of OM', 'Incidence and Severity of Mucositis', 'selenium level', 'mean serum selenium level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}]",71.0,0.0814545,"The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24)","[{'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Laali', 'Affiliation': ''}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Manifar', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kazemian', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jahangard-Rafsanjani', 'Affiliation': ''}, {'ForeName': 'Kheirollah', 'Initials': 'K', 'LastName': 'Gholami', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45080']
1876,32895665,RDA and REA Values of Commercially Available Toothpastes Utilising Diamond Powder and Traditional Abrasives.,"PURPOSE


To investigate whether toothpastes with diamond powder vs those with traditional abrasives abrade dentin and enamel differently and to determine the relative dentin abrasivity (RDA) and relative enamel abrasivity (REA) values of those toothpastes.
MATERIALS AND METHODS


Dentin and enamel samples of bovine permanent incisors were randomly allocated into groups of eight, brushed with 20 different toothpastes (three of which contained diamond powder) and analysed for their RDA and REA values.
RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values. Some RDA values exceeded the ones declared by the manufacturer.
CONCLUSION


Diamond powder as an abrasive might have a mild action on dentin, but it is highly abrasive on enamel.",2020,"RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values.",['Dentin and enamel samples of bovine permanent incisors'],['toothpastes with diamond powder'],"['RDA and REA Values', 'relative dentin abrasivity (RDA) and relative enamel abrasivity (REA) values', 'RDA values']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0175257,"RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values.","[{'ForeName': 'Blend', 'Initials': 'B', 'LastName': 'Hamza', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cucuzza', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gubler', 'Affiliation': ''}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Wegehaupt', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45085']
1877,32897234,"Evaluation of a Package of Behaviour Change Interventions (Baduta Program) to Improve Maternal and Child Nutrition in East Java, Indonesia: Protocol for an Impact Study.","BACKGROUND


Over the past decade, the prevalence of stunting has been close to 37% in children aged <5 years in Indonesia. The Baduta program, a multicomponent package of interventions developed by the Global Alliance for Improved Nutrition, aims to improve maternal and infant nutrition in Indonesia.
OBJECTIVE


This study aims to assess the impact of the Baduta program, a package of health system strengthening and behavior change interventions, compared with the standard village health services on maternal and child nutrition.
METHODS


The impact evaluation uses a cluster randomized controlled trial design with 2 outcome assessments. The first uses cross-sectional surveys of mothers of children aged 0-23 months and pregnant women before and after the interventions. The second is a cohort study of pregnant women followed until their child is 18 months from a subset of clusters. We will also conduct a process evaluation guided by the program impact pathway to assess coverage, fidelity, and acceptance. The study will be conducted in the Malang and Sidoarjo districts of East Java, Indonesia. The unit of randomization is the subdistricts. As random allocation of interventions to only 6 subdistricts is feasible, we will use constrained randomization to ensure balance of baseline covariates. The first intervention will be health system strengthening, including the Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF). The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices. The primary study outcome is child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes. The sample size for each cross-sectional survey is 1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group. The cohort evaluation requires a sample size of 340 mother-infant pairs in each treatment group. We will seek Gatekeeper consent and written informed consent from the participants. The intention-to-treat principle will guide our data analysis, and we will apply Consolidated Standards of Reporting Trials guidelines for clustered randomized trials in the analysis.
RESULTS


In February 2015, we conducted a baseline cross-sectional survey on 2435 women with children aged <2 years and 409 pregnant women. In February 2017, we conducted an end-line survey on 2740 mothers with children aged <2 years and 642 pregnant women. The cohort evaluation began in February 2015, with 729 pregnant women, and was completed in December 2016.
CONCLUSIONS


The results of the program evaluation will help guide policies to support effective packages of behavior change interventions to prevent child stunting in Indonesia.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18521.",2020,"The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices.","['729 pregnant women, and was completed in December 2016', '2435 women with children aged <2 years and 409 pregnant women', '1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group', 'children aged <5 years in Indonesia', '340 mother-infant pairs in each treatment group', 'Malang and Sidoarjo districts of East Java, Indonesia', 'mothers of children aged 0-23 months and pregnant women before and after the interventions', '2740 mothers with children aged <2 years and 642 pregnant women', 'pregnant women followed until their child is 18 months from a subset of clusters']","['Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF', 'Package of Behaviour Change Interventions']","['child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",2740.0,0.0950176,"The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices.","[{'ForeName': 'Michael John', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Umi', 'Initials': 'U', 'LastName': 'Fahmida', 'Affiliation': 'SEAMEO RECFON-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Ariawan', 'Affiliation': 'Center for Health Research, Faculty of Public Health, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Christiana Rialine', 'Initials': 'CR', 'LastName': 'Titaley', 'Affiliation': 'Faculty of Medicine, Pattimura University, Ambon City, Indonesia.'}, {'ForeName': 'Min Kyaw', 'Initials': 'MK', 'LastName': 'Htet', 'Affiliation': 'SEAMEO RECFON-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Damayanti', 'Affiliation': 'Center for Health Research, Faculty of Public Health, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Aang', 'Initials': 'A', 'LastName': 'Sutrisna', 'Affiliation': 'Indonesia Office, Global Alliance for Improved Nutrition, Jakarta, Indonesia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.'}]",JMIR research protocols,['10.2196/18521']
1878,32897236,Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial.,"BACKGROUND


The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults.
OBJECTIVE


This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish.
METHODS


A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
RESULTS


The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023.
CONCLUSIONS


This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17840.",2020,"Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
","['older adults', 'adults aged 62 or older', 'younger individuals in the dental care of older adults', 'Older Adults', '22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants']","['silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish', '2 evidence-based nonsurgical strategies']","['caries lesion arrest, tooth sensitivity, and tooth pain', 'Oral Health Disparities']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.351444,"Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Nelson', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Albert', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Milgrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}]",JMIR research protocols,['10.2196/17840']
1879,32894809,Effect of hypertriglyceridemia in dyslipidemia-induced impaired glucose tolerance and sex differences in dietary features associated with hypertriglyceridemia among the Japanese population: The Gifu Diabetes Study.,"AIMS/INTRODUCTION


The mechanisms underlying hypertriglyceridemia-induced impaired glucose tolerance in Japanese individuals remain unclear. We aimed to evaluate the effect of hypertriglyceridemia on glucose metabolism in comparison with that of increased low-density lipoprotein or decreased high-density lipoprotein levels and to elucidate the sex differences in hypertriglyceridemia-related dietary intake among Japanese individuals.
MATERIALS AND METHODS


We randomly selected 898 (384 men and 514 women) participants aged 40-78 years in the Gifu Diabetes Study; those taking medication for dyslipidemia or diabetes mellitus were excluded. Serum levels of glucose metabolism parameters and the food frequency were measured cross-sectionally. The glycated hemoglobin was measured again after 5 years.
RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance were significantly higher in the high triglyceride group in men and women. Similar trends were observed in the low high-density lipoprotein group, but only in men. Meanwhile, only the homeostasis model assessment of insulin resistance was higher in the high low-density lipoprotein group. In non-obese men, the percentage of energy intake from alcohol per total daily energy intake was significantly greater in the high triglyceride group. In obese women, the total energy intake was significantly greater in the high triglyceride group. At the 5-year follow up, the risk of elevated glycated hemoglobin levels with hypertriglyceridemia was increased in men.
CONCLUSIONS


Hypertriglyceridemia is a stronger risk factor for impaired glucose tolerance than increased low-density lipoprotein or decreased high-density lipoprotein. For dietary habits, increased daily alcohol energy intake in non-obese men and increased total energy intake in obese women were associated with hypertriglyceridemia.",2020,"RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance was significantly higher in high triglyceride (TG) group in men and women.","['obese women', 'We randomly selected 898 (384 men and 514 women) participants aged 40-78 years in the Gifu Diabetes Study; those with medication for dyslipidemia or diabetes mellitus were excluded', 'non-obese men', 'Japanese population']","['hypertriglyceridemia', 'triglyceride (TG']","['total energy intake', 'homeostasis model assessment-insulin resistance', 'density lipoprotein (HDL) levels', 'percentage of energy intake from alcohol per total daily energy intake', 'hypertriglyceridemia', 'percentage of individuals with impaired glucose tolerance', 'Serum levels of glucose metabolism parameters and the food frequency', 'glycated hemoglobin (HbA1c', 'daily alcohol energy intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",898.0,0.0432657,"RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance was significantly higher in high triglyceride (TG) group in men and women.","[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nonoyama', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Health Administration Center, and United Graduate School of Drug Discovery and Medical Information Sciences, Gifu University, Gifu, Japan.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Graduate School of Health Sciences, Gunma University, Maebashi, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Horikawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Nagata', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeda', 'Affiliation': 'Takeda hospital, Kyoto, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13398']
1880,32902313,"Satisfaction, utilization, and feasibility of a telehealth intervention for in-home dementia care support: A mixed methods study.","BACKGROUND


Technology can enhance support for families caring for persons living with dementia but must be acceptable to be adopted. The FamTechCare clinical trial engaged caregivers in video recording care encounters that were reviewed by an expert panel who provided tailored feedback. The intervention reduced caregiver depression and improved caregiver competence. This mixed methods study reports on caregiver satisfaction and utilization of the intervention and expert panel evaluation of the intervention.
METHODS


A convergent parallel mixed methods design was used to evaluate the satisfaction, usability, and feasibility of the FamTechCare intervention. In the multisite randomized controlled trial, caregiver-person living with dementia dyads were randomized to the FamTechCare video support or attention control telephone support groups. Caregivers completed a satisfaction survey at the completion of the 3-month trial. Utilization was evaluated using the number and duration of videos submitted and calls received by caregivers. Relationships between participant characteristics and their satisfaction and utilization were evaluated. Feasibility of the intervention was assessed through content analysis of interviews with the expert panel.
RESULTS


The majority of caregivers in both groups reported benefits from participation. More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers. FamTechCare caregivers of persons with more severe dementia were more likely to report that video recording intruded on their privacy ( p  = 0.050). Caregiver age, gender, education, dyad relationship, rural status, and type and severity of dementia were not associated with ratings of acceptability, ease of use, or intervention utilization. The expert panel described the FamTechCare intervention as useful and identified adaptations to enhance feasibility.
CONCLUSION


Regardless of age, gender, and relationship, caregivers found the intervention acceptable and easy to use and rated the expert feedback as effective in addressing care challenges. Further adaptation may be needed for FamTechCare to be readily implemented.",2020,More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers.,"['home dementia care support', 'families caring for persons living with dementia', 'caregiver-person living with dementia dyads', 'FamTechCare caregivers of persons with more severe dementia']","['FamTechCare intervention', 'FamTechCare video support or attention control telephone support groups']","['satisfaction, usability, and feasibility', 'Satisfaction, utilization, and feasibility of a telehealth intervention', 'caregiver depression and improved caregiver competence']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0518323,More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers.,"[{'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, 21638University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, 21638University of Kansas, Kansas City, KS, USA.'}]","Dementia (London, England)",['10.1177/1471301220957905']
1881,32902321,Study of usefulness of low-dose IgG for patients with septic disseminated intravascular coagulation.,"Aim:  Improving prognosis with intravenous IgG (IVIG) has been ruled out in a large, multicenter, randomized controlled trial in patients with sepsis. However, its efficacy in the case of septic disseminated intravascular coagulation (DIC) has not been well studied.  Results, materials & methods:  We retrospectively evaluated the effects of IVIG on severity scores and 28-day survival in patients with septic DIC. A total of 80 patients with septic DIC were enrolled. Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  Discussion & conclusion:  IVIG treatment significantly reduced the Sequential Organ Failure Assessment scores and DIC scores and increased platelet counts, but the 28-day mortality rate did not decrease significantly.",2020,"Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  ","['patients with septic DIC', 'patients with sepsis', 'patients with septic disseminated intravascular coagulation', '80 patients with septic DIC were enrolled']","['intravenous IgG (IVIG', 'IVIG', 'low-dose IgG']","['28-day mortality rate', 'Sequential Organ Failure Assessment scores and DIC scores and increased platelet counts', 'severity scores and 28-day survival', 'Changes in infection-related markers, coagulation-related markers, severity scores\xa0and 28-day survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857460', 'cui_str': 'Platelet count above reference range'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]",80.0,0.227407,"Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  ","[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Takahashi', 'Affiliation': 'Department of Critical Care & Disaster, General Medicine, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Critical Care & Disaster, General Medicine, Iwate Medical University, Iwate, Japan.'}]",Biomarkers in medicine,['10.2217/bmm-2020-0204']
1882,32909660,"A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER).","BACKGROUND


The anti-interleukin 13 (IL-13) monoclonal antibody lebrikizumab improves lung function in patients with moderate-to-severe uncontrolled asthma, but its effects on airway inflammation and remodelling are unknown. CLAVIER was designed to assess lebrikizumab's effect on eosinophilic inflammation and remodelling.
OBJECTIVE


To report safety and efficacy results from enrolled participants with available data from CLAVIER.
METHODS


We performed bronchoscopy on patients with uncontrolled asthma before and after 12 weeks of randomized double-blinded treatment with lebrikizumab (n = 31) or placebo (n = 33). The pre-specified primary end-point was relative change in airway subepithelial eosinophils per mm 2  of basement membrane (cells/mm 2  ). Pre-specified secondary and exploratory outcomes included change in IL-13-associated biomarkers and measures of airway remodelling.
RESULTS


There was a baseline imbalance in tissue eosinophils and high variability between treatment groups. There was no discernible change in adjusted mean subepithelial eosinophils/mm 2  in response to lebrikizumab (95% CI, -82.5%, 97.5%). As previously observed, FEV 1  increased after lebrikizumab treatment. Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26 and SERPINB2 mRNA expression in bronchial tissues also reduced. Lebrikizumab was well tolerated, with a safety profile consistent with other lebrikizumab asthma studies.
CONCLUSIONS & CLINICAL RELEVANCE


We did not observe reduced tissue eosinophil numbers in association with lebrikizumab treatment. However, in pre-specified exploratory analyses, lebrikizumab treatment was associated with reduced degree of subepithelial fibrosis, a feature of airway remodelling, as well as improved lung function and reduced key pharmacodynamic biomarkers in bronchial tissues. These results reinforce the importance of IL-13 in airway pathobiology and suggest that neutralization of IL-13 may reduce asthmatic airway remodelling.
CLINICAL TRIAL REGISTRATION


NCT02099656.",2020,"Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues also reduced.","['patients with moderate to severe uncontrolled asthma', 'enrolled participants with available data from CLAVIER', 'patients with uncontrolled asthma before and after 12 weeks']","['Lebrikizumab', 'placebo', 'lebrikizumab']","['relative change in airway subepithelial eosinophils', 'airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER', 'eosinophilic inflammation and remodelling', 'IL-13-associated biomarkers and measures of airway remodelling', 'lung function', 'fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues', 'subepithelial collagen thickness', 'degree of subepithelial fibrosis', 'tissue eosinophil numbers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2981360', 'cui_str': 'lebrikizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0907797', 'cui_str': 'CCL26 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0229610', 'cui_str': 'Tissue eosinophil'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.235184,"Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues also reduced.","[{'ForeName': 'Cary D', 'Initials': 'CD', 'LastName': 'Austin', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gonzalez Edick', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Ferrando', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Solon', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Baca', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mesh', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'University of Leicester and Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Gauvreau', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Washington University School of Medicine in St. Louis, St Louis, MO, USA.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Lief', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Arron', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Olsson', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Abreu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Monet', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cai', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Putnam', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Cécile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Matthews', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Prescott G', 'Initials': 'PG', 'LastName': 'Woodruff', 'Affiliation': 'San Francisco Medical Center, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13731']
1883,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2020,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
1884,32905598,"Corrigendum to: ""Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial"".",,2020,,['Children With GH Deficiency'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714796', 'cui_str': 'Isolated somatotropin deficiency'}]",[],[],,0.127536,,[],The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa614']
1885,32905615,Metronidazole and amoxicillin for patients with periodontitis and diabetes mellitus: 5 years secondary analysis of a randomized controlled trial.,"BACKGROUND


The aim of this study was to perform a 5-year follow-up analysis of a previously-published randomized trial (RCT) evaluating the 2-years effects of metronidazole (MTZ) plus amoxicillin (AMX) as adjuncts to scaling and root planing (SRP) in the treatment of periodontitis in type 2 diabetic patients.
METHODS


Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation. Patients did not receive regular supportive periodontal therapy (SPT) from 2 to 5 years post-treatment.
RESULTS


Of the patients enrolled in the RCT, 43% entered this study (n = 10/control and 15/test group). Most of clinical parameter values, including the number of sites with probing depth ≥ 5 mm (primary outcome variable), were reduced at 5 years post-therapy when compared with baseline in the antibiotic-treated group (P < 0.05), but presented higher values than those at 2 years (P < 0.05). The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
CONCLUSION


Diabetic patients treated with adjunctive MTZ+AMX were better maintained over a period of 5 years than those treated with SRP only. However, the clinical and microbiological benefits obtained up to 2 years post-treatment were not fully sustained in these patients who did not receive SPT between 2 and 5 years post-treatment.",2020,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
","['patients with periodontitis and diabetes mellitus', 'Diabetic patients treated with', 'Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation', 'periodontitis in type 2 diabetic patients']","['adjunctive MTZ+AMX', 'regular supportive periodontal therapy (SPT', 'Metronidazole and amoxicillin', 'metronidazole (MTZ) plus amoxicillin (AMX', 'root planing (SRP', 'RCT']",['mean proportions of microbial complexes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",,0.0568194,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
","[{'ForeName': 'Daniele Ferreira da', 'Initials': 'DFD', 'LastName': 'Cruz', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Poliana Mendes', 'Initials': 'PM', 'LastName': 'Duarte', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'de Figueiredo', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Hélio Doyle Pereira', 'Initials': 'HDP', 'LastName': 'da Silva', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Tamires Szeremeske', 'Initials': 'TS', 'LastName': 'Miranda', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0196']
1886,32901199,Does learning a skill with the expectation of teaching it impair the skill's execution under psychological pressure if the skill is learned with analogy instructions?,"Objective


Having learners practice a motor skill with the expectation of teaching it (versus an expectation of being tested on it) has been revealed to enhance skill learning. However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.' The present study will investigate whether this choking effect is caused by an accrual of declarative knowledge during skill practice and could be prevented if a technique (analogy instructions) to minimize the accrual of declarative knowledge during practice is employed.
Design


We will use a 2 (Expectation: teach/test) x 2 (Instruction: analogy/explicit) x 2 (Posttest: high-pressure/low-pressure) mixed-factor design, with repeated measures on the last factor.
Methods


A minimum of 148 participants will be quasi-randomly assigned (based on sex) to one of four groups. Participants in the teach/analogy and teach/explicit groups will practice golf putting with the expectation of teaching putting to another participant, and analogy instructions or explicit instructions, respectively. Participants in the test/analogy and test/explicit groups will practice golf putting with the expectation of being tested on their putting, and analogy instructions or explicit instructions, respectively. The next day all participants will complete low- and high-pressure putting posttests, with their putting accuracy serving as the dependent variable.",2020,"However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.'",['148 participants will be quasi-randomly assigned (based on sex) to one of four groups'],[],['skill performance'],"[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],[],148.0,0.0272957,"However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.'","[{'ForeName': 'Daniel A R', 'Initials': 'DAR', 'LastName': 'Cabral', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Daou', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Williams-Brice 111, P.O. Box 261954, Conway, SC, 29528, USA.'}, {'ForeName': 'Mariane F B', 'Initials': 'MFB', 'LastName': 'Bacelar', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Juliana O', 'Initials': 'JO', 'LastName': 'Parma', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Miller', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}]",Psychology of sport and exercise,['10.1016/j.psychsport.2020.101757']
1887,32902387,Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial.,"BACKGROUND


Society is facing a global shortage of 17 million health care workers, along with increasing health care demands from a growing number of older adults. Social robots are being considered as solutions to part of this problem.
OBJECTIVE


Our objective is to evaluate the quality of care perceived by patients and caregivers for an integrated care pathway in an outpatient clinic using a social robot for patient-reported outcome measure (PROM) interviews versus the currently used professional interviews.
METHODS


A multicenter, two-parallel-group, nonblinded, randomized controlled trial was used to test for noninferiority of the quality of care delivered through robot-assisted care. The randomization was performed using a computer-generated table. The setting consisted of two outpatient clinics, and the study took place from July to December 2019. Of 419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment. Inclusion criteria were the ability to speak and read Dutch and being assisted by a participating health care professional. Exclusion criteria were serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems. The intervention consisted of a social robot conducting a 36-item PROM. As the main outcome measure, the customized Consumer Quality Index (CQI) was used, as reported by patients and caregivers for the outpatient pathway of care.
RESULTS


In total, 75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years. There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58. There was no significant difference in the total CQI scores between caregivers in the intervention group (mean 9.21, SD 0.76, n=30) and those in the control group (mean 9.09, SD 0.60, n=35): P=.47, 95% CI -0.21 to 0.46. No harm or unintended effects occurred.
CONCLUSIONS


Geriatric patients and their informal caregivers valued robot-assisted and nonrobot-assisted care pathways equally.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03857789; https://clinicaltrials.gov/ct2/show/NCT03857789.",2020,"There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58.","['17 million health care workers', '75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years', '419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment', 'Older Patients and Caregivers in Integrated Care Pathways']","['social robot conducting a 36-item PROM', 'Interviewing Assistance From a Social Robot', 'robot-assisted care']","['total patient CQI scores', 'total CQI scores', 'serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems', 'customized Consumer Quality Index (CQI']","[{'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",75.0,0.107016,"There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58.","[{'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Boumans', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Fokke', 'Initials': 'F', 'LastName': 'van Meulen', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'van Aalst', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Albers', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Marèse', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Peters-Kop', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Getty', 'Initials': 'G', 'LastName': 'Huisman-de Waal', 'Affiliation': 'IQ healthcare, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'van de Poll', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hindriks', 'Affiliation': 'Social AI Group, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Neerincx', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Olde Rikkert', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/18787']
1888,32902389,Validity and Usability of a Smartphone Image-Based Dietary Assessment App Compared to 3-Day Food Diaries in Assessing Dietary Intake Among Canadian Adults: Randomized Controlled Trial.,"BACKGROUND


Accurate dietary assessment is needed in studies that include analysis of nutritional intake. Image-based dietary assessment apps have gained in popularity for assessing diet, which may ease researcher and participant burden compared to traditional pen-to-paper methods. However, few studies report the validity of these apps for use in research. Keenoa is a smartphone image-based dietary assessment app that recognizes and identifies food items using artificial intelligence and permits real-time editing of food journals.
OBJECTIVE


This study aimed to assess the relative validity of an image-based dietary assessment app - Keenoa - against a 3-day food diary (3DFD) and to test its usability in a sample of healthy Canadian adults.
METHODS


We recruited 102 participants to complete two 3-day food records. For 2 weeks, on 2 non-consecutive days and 1 weekend day, in random order, participants completed a traditional pen-to-paper 3DFD and the Keenoa app. At the end of the study, participants completed the System Usability Scale. The nutrient analyses of the 3DFD and Keenoa data before (Keenoa-participant) and after they were reviewed by dietitians (Keenoa-dietitian) were analyzed using analysis of variance. Multiple tests, including the Pearson coefficient, cross-classification, kappa score, % difference, paired t test, and Bland-Altman test, were performed to analyze the validity of Keenoa (Keenoa-dietitian).
RESULTS


The study was completed by 72 subjects. Most variables were significantly different between Keenoa-participant and Keenoa-dietitian (P<.05) except for energy, protein, carbohydrates, fiber, vitamin B1, vitamin B12, vitamin C, vitamin D, and potassium. Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05). The Pearson correlation coefficients between the Keenoa-dietitian and 3DFD ranged from .04 to .51. Differences between the mean intakes assessed by the 3DFD and Keenoa-dietitian were within 10% except for vitamin D (misclassification rate=33.8%). The majority of nutrients were within an acceptable range of agreement in the Bland-Altman analysis; no agreements were seen for total energy, protein, carbohydrates, fat (%), saturated fatty acids, iron, potassium, and sodium (P<.05). According to the System Usability Scale, 34.2% of the participants preferred using Keenoa, while 9.6% preferred the 3DFD.
CONCLUSIONS


The Keenoa app provides acceptable relative validity for some nutrients compared to the 3DFD. However, the average intake of some nutrients, including energy, protein, carbohydrates, % fat, saturated fatty acids, and iron, differed from the average obtained using the 3DFD. These findings highlight the importance of verifying data entries of participants before proceeding with nutrient analysis. Overall, Keenoa showed better validity at the group level than the individual level, suggesting it can be used when focusing on the dietary intake of the general population. Further research is recommended with larger sample sizes and objective dietary assessment approaches.",2020,"Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05).","['102 participants to complete two 3-day food records', '72 subjects', 'healthy Canadian adults', 'Canadian Adults']","['traditional pen-to-paper 3DFD and the Keenoa app', 'Smartphone Image-Based Dietary Assessment', 'image-based dietary assessment app - Keenoa - against a 3-day food diary (3DFD']","['validity of Keenoa (Keenoa-dietitian', 'Dietary Intake', 'total energy, protein, carbohydrates, fat (%), saturated fatty acids, iron, potassium, and sodium (P<.05', 'total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium', '3DFD and Keenoa-dietitian', 'System Usability Scale', 'energy, protein, carbohydrates, fiber, vitamin B1, vitamin B12, vitamin C, vitamin D, and potassium']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",102.0,0.0531668,"Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05).","[{'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Plourde', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Bouzo', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kilgour', 'Affiliation': 'Department of Health, Kinesiology, and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara R', 'Initials': 'TR', 'LastName': 'Cohen', 'Affiliation': 'PERFORM Centre, Concordia University, Montreal, QC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/16953']
1889,32902390,"Age and Attitudes Towards an Internet-Mediated, Pedometer-Based Physical Activity Intervention for Chronic Obstructive Pulmonary Disease: Secondary Analysis.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is prevalent among older adults. Promoting physical activity and increasing exercise capacity are recommended for all individuals with COPD. Pulmonary rehabilitation is the standard of care to improve exercise capacity, although there are barriers that hinder accessibility. Technology has the potential to overcome some of these barriers, but it is unclear how aging adults with a chronic disease like COPD perceive technology-based platforms to support their disease self-management.
OBJECTIVE


Guided by the unified theory of acceptance and use of technology, the current retrospective secondary analysis explores if age moderates multiple factors that influence an individual with COPD's openness toward an internet-mediated, pedometer-based physical activity intervention.
METHODS


As part of an efficacy study, participants with COPD (N=59) were randomly assigned to use an internet-mediated, pedometer-based physical activity intervention for 12 weeks. At completion, they were asked about their experience with the intervention using a survey, including their performance expectancy and effort expectancy, facilitating conditions (ie, internet use frequency and ability), and use of the intervention technology. Logistic regression and general linear modeling examined the associations between age and these factors.
RESULTS


Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93). Disease severity was measured by forced expiratory volume in the first second percent predicted (mean 60.01, SD 20.86). Nearly all participants (54/59) believed the intervention was useful. Regarding effort expectancy, increasing age was associated with reporting that it was easy to find the time to engage in the intervention. Regarding facilitating conditions, approximately half of the participants believed the automated step count goals were too high (23/59) and many did not feel comfortable reaching their goals (22/59). The probability of these perceptions increased with age, even after accounting for disease severity. Age was not associated with other facilitating conditions or use of the technology.
CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention. Age is associated with certain expectations of effort and facilitating conditions. Consideration of age of the user is needed when personalizing step count goals and time needed to log in to the website.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01772082; https://clinicaltrials.gov/ct2/show/NCT01772082.",2020,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","['older adults', 'Chronic Obstructive Pulmonary Disease', 'Chronic obstructive pulmonary disease (COPD', 'Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93', 'individuals with COPD', 'participants with COPD (N=59']","['internet-mediated, pedometer-based physical activity intervention', 'Pedometer-Based Physical Activity Intervention']","['Age and Attitudes', 'forced expiratory volume', 'Disease severity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0549655,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Wan', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}]",JMIR aging,['10.2196/19527']
1890,32915158,Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial.,"BACKGROUND


Low physical activity levels can negatively affect the health of nurses. Given the low physical activity levels reported by nurses, there is a clear need for brief and economical interventions designed to increase physical activity levels in this population. We developed a web-based intervention that used motivational strategies to increase nurses' physical activity levels. The intervention provided the nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge.
OBJECTIVE


In this parallel-group randomized trial, we examine whether nurses' motivation at baseline predicted changes in objectively measured physical activity levels during the 6-week intervention.
METHODS


The participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3 physical activity challenge conditions: (1) individual, (2) friend, or (3) team. The nurses completed a web-based questionnaire designed to assess motivational regulations for physical activity levels before the intervention and wore a Tractivity activity monitor before and during the 6-week intervention. We analyzed data using multilevel modeling for repeated measures.
RESULTS


The nurses' physical activity levels increased (linear estimate=10.30, SE 3.15; P=.001), but the rate of change decreased over time (quadratic estimate=-2.06, SE 0.52; P<.001). External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
CONCLUSIONS


Our findings provide evidence that an intervention that incorporates self-monitoring and physical activity challenges can be generally effective in increasing nurses' physical activity levels in the short term. They also suggest that drawing solely on organismic integration theory to predict changes in physical activity levels among the nurses participating in web-based worksite interventions may have been insufficient. Future research should examine additional personal (eg, self-efficacy) and occupational factors (eg, shift length and shift type) that influence physical activity levels to identify potential targets for intervention among nurses.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04524572; https://clinicaltrials.gov/ct2/show/NCT04524572.",2020,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","['participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3']","['nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge', 'physical activity challenge conditions: (1) individual, (2) friend, or (3) team', 'Worksite Intervention']","[""Nurses' Physical Activity Levels"", ""nurses' physical activity levels"", 'physical activity levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",76.0,0.0444141,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wolfe Phillips', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/11543']
1891,32915162,"Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.","BACKGROUND


In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.
OBJECTIVE


This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.
METHODS


The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.
RESULTS


Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.
CONCLUSIONS


This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18051.",2020,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","['young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection', '41 participants were enrolled in the community-based pilot', 'Young Men', 'Men and Transgender Youth of Color (Phase 3']",['Employment Intervention Program'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],41.0,0.0463592,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Hill', 'Affiliation': 'Planned Parenthood Great Plains, Overland Park, KS, United States.'}, {'ForeName': 'Darnell N', 'Initials': 'DN', 'LastName': 'Motley', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rosentel', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'VandeVusse', 'Affiliation': 'Guttmacher Institute, New York, NY, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Kipke', 'Affiliation': ""Division of Research on Children, Youth, and Families, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Reisner', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Rupp', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'West Goolsby', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McCumber', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Renshaw', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, United States.'}]",JMIR research protocols,['10.2196/18051']
1892,32909954,The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial.,"BACKGROUND


Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking.
OBJECTIVE


This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits.
METHODS


Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application.
RESULTS


Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023.
CONCLUSIONS


The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18211.",2020,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","['Low-Income Women', '9 health care regions in Louisiana with the goal of enrolling 432 women', 'Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits']","['sustainable eHealth program', 'Pragmatic and Scalable eHealth Intervention']","['healthy weight gain', 'Gestational Weight Gain', 'healthy gestational weight gain (GWG) recommendations']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0425006', 'cui_str': 'Child benefit'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",432.0,0.16195,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","[{'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Flanagan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Abby D', 'Initials': 'AD', 'LastName': 'Altazan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Comardelle', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'L Anne', 'Initials': 'LA', 'LastName': 'Gilmore', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'St Romain', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Hardee', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Renee S', 'Initials': 'RS', 'LastName': 'Puyau', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Mayet', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'S Ariel', 'Initials': 'SA', 'LastName': 'Barlow', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Sarah Surber', 'Initials': 'SS', 'LastName': 'Bounds', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Kelsey N', 'Initials': 'KN', 'LastName': 'Olson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Betty M', 'Initials': 'BM', 'LastName': 'Kennedy', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}]",JMIR research protocols,['10.2196/18211']
1893,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
1894,32905863,Behavioral and neurological effects of tDCS on speech motor recovery: A single-subject intervention study.,"This paper reports a feasibility study designed to evaluate the behavioral and neurological effects of using transcranial direct current stimulation (tDCS) in conjunction with speech motor learning treatment for individuals with acquired speech impairment subsequent to stroke. Most of the research using tDCS to enhance treatment outcomes in stroke recovery has focused on either limb motor control or aphasia treatment. Using a multiple-baseline multiple-probe crossover design, we compared both behavioral and brain connectivity-based outcomes following speech motor learning treatment with both Active tDCS and Sham tDCS. We observed that both treatment phases led to improvement in short-term maintenance, but that Active tDCS was associated with greater long-term maintenance improvement. Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment. This report supports the possibility that tDCS may enhance both behavioral and neurological outcomes and indicates the importance of additional work in this area, although replication is required to confirm the extent and consistency of tDCS benefits on speech motor learning treatment outcomes.",2020,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,['individuals with acquired speech impairment subsequent to stroke'],"['speech motor learning treatment with both Active tDCS and Sham tDCS', 'transcranial direct current stimulation (tDCS', 'tDCS', 'speech motor learning treatment']","['functional connectivity', 'speech motor recovery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0164864,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buchwald', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA. Electronic address: buchwald@nyu.edu.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Khosa', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rimikis', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'E Susan', 'Initials': 'ES', 'LastName': 'Duncan', 'Affiliation': 'Louisiana State University, Department of Communication Sciences and Disorders, 68 Hatcher Hall, Baton Rouge, LA 70803, USA.'}]",Brain and language,['10.1016/j.bandl.2020.104849']
1895,32905889,Role of inhaled corticosteroids in reducing exacerbations in bronchiectasis patients with blood eosinophilia pooled post-hoc analysis of 2 randomized clinical trials.,,2020,,['bronchiectasis patients with blood eosinophilia'],['inhaled corticosteroids'],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.174446,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. Electronic address: lsaderi@uniss.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Respiratory medicine,['10.1016/j.rmed.2020.106127']
1896,32905893,12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD.,"Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.",2020,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"['134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient', 'patients with severe COPD']","['pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group', 'pulmonary tele-rehabilitation versus standard pulmonary rehabilitation']",['minutes walking distance (6MWD'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",134.0,0.0811644,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Nina.Skavlan.Godtfredsen@regionh.dk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Copenhagen, And Innovation and Research Centre for Multimorbidity and Chronic Conditions, Region Zealand, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical & Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Respiratory Medicine, Gentofte and Herlev University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle Frost', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106129']
1897,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable  MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE


For localized, resectable neuroblastoma without  MYCN  amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS


Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS


Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively;  P  = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively;  P  = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%,  P  = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%,  P  = .038).
CONCLUSION


Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
1898,32865377,Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.,"BACKGROUND


Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.
METHODS


In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.
RESULTS


During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m 2  of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.
CONCLUSIONS


Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).",2020,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","['patients regardless of the presence or absence of diabetes', '3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive', 'Heart Failure', 'patients receiving recommended therapy for heart failure, those in the']","['Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'Empagliflozin', 'empagliflozin', 'placebo']","['presence or absence of diabetes', 'Cardiovascular and Renal Outcomes', 'lower risk of serious renal outcomes', 'cardiovascular death or hospitalization for heart failure', 'glomerular filtration rate', 'Uncomplicated genital tract infection', 'composite of cardiovascular death or hospitalization for worsening heart failure', 'total number of hospitalizations for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C2314882', 'cui_str': 'Genital Tract Infections'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",3730.0,0.648207,"The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Carson', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Januzzi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schnee', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Chuquiure', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Giannetti', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Gonzalez Juanatey', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner-La Rocca', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Perrone', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Pina', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Seronde', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) - all in the United Kingdom; the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim International, Ingelheim (M. Brueckmann, W.J.), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann), Boehringer Ingelheim Pharma, Biberach (C.Z.), Klinik für Innere Medizin III, Saarland University, Homburg-Saar (M. Böhm), and the Department of Medicine, University Hospital of Würzburg, Würzburg (C.W.) - all in Germany; the Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens (G.F.); Washington DC Veterans Affairs Medical Center, Washington DC (P.C.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.J.); the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.), Boehringer Ingelheim Canada, Burlington, ON (K.K.), and the Division of Cardiology, McGill University and Health Centre, Montreal (N.G.) - all in Canada; the Department of Cardiovascular Medicine, Kyushu University, Higashi-ku, Fukuoka, Japan (H.T.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J. Schnee, D.C.); Heart Institute, São Paulo University Medical School, São Paulo (E.B.); the Department of Medicine, Seoul National University, Seoul, South Korea (D.-J.C.); the Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India (V.C.); the Department of Clinical Cardiology, National Institute of Cardiology, Mexico City (E.C.); the Department of Cardiology, University Hospital Gasthuisberg of Leuven, Leuven, Belgium (S.J.); Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z.); the Cardiology Department, University Hospital, Santiago de Compostela, Spain (J.R.G.J.); the Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles (S.K.); Maastricht Heart and Vascular Center, Maastricht, the Netherlands (H.P.B.-L.R.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Victorian Heart Institute and Monash University, Melbourne, VIC, Australia (S.J.N.); Fleni Institute and Hospital El Cruce-Nestor Kirchner, Buenos Aires (S.P.); the Department of Medicine, Wayne State and Central Michigan Universities, Detroit (I.P.); the Center for Heart Diseases, Wrocław Medical University, Wrocław, Poland (P.P.); the Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and the Department of Clinical and Experimental Medicine, University of Pisa, Pisa (S.T.) - both in Italy; the Department of Cardiology, University Hospital Jean Minjoz, Besançon (M.-F.S.), and Université de Lorraine, INSERM Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional Universitaire, Nancy (F.Z.) - both in France; and Internal Cardiology, University Hospital Brno, Brno, Czech Republic (J. Spinar).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022190']
1899,32901526,Evaluation and clinical comparison studies on liposomal and non-liposomal ascorbic acid (vitamin C) and their enhanced bioavailability.,"The aim of this study was to evaluate the oral bioavailability of liposomal vitamin C and non-liposomal vitamin C in healthy, adult, human subjects under fasting conditions through an open label, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover, study. The vitamin C loaded liposome was well characterized using transmission electron microscopy (TEM), dynamic light scattering (DLS) and zeta potential measurements for evaluating morphology, particle size and stabilities, respectively. Microscopic image shows the core-type structure that confirms the characteristic pattern of liposome. The encapsulation efficiency (EE%) and the particle size were 65.85 ± 1.84% and below 100 nm, respectively. The results of the clinical studies of liposomal vitamin C by oral delivery to be 1.77 times more bioavailable than non-liposomal vitamin C. The liposomal vitamin C demonstrated higher values of C max , AUC 0-   t  and AUC 0-∞  related to non-liposomal vitamin C due to liposomal encapsulation. No adverse events were reported. It could be concluded that liposomal encapsulated ascorbic acid (vitamin C) shows well-organized morphological pattern, uniform particle size and highly efficient, which leads to have enhanced bioavailability.",2020,"The Liposomal Vitamin C demonstrated higher values of C max , AUC 0-t  and AUC 0-∞  related to non-liposomal Vitamin C due to liposomal encapsulation.","['healthy, adult, human subjects under fasting conditions']","['Liposomal and Non-Liposomal Ascorbic Acid  (Vitamin C', 'Liposomal Vitamin C', 'liposomal encapsulated ascorbic acid (vitamin c', 'liposomal vitamin C', 'liposomal vitamin C and non-liposomal vitamin C']","['encapsulation efficiency (EE%) and the particle size', 'adverse events', 'C max , AUC 0-t  and AUC', 'oral bioavailability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0377385,"The Liposomal Vitamin C demonstrated higher values of C max , AUC 0-t  and AUC 0-∞  related to non-liposomal Vitamin C due to liposomal encapsulation.","[{'ForeName': 'Sreerag', 'Initials': 'S', 'LastName': 'Gopi', 'Affiliation': 'Centre for Innovations and Technologies (CIT), ADSO Naturals Private Limited, Bangalore, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Balakrishnan', 'Affiliation': 'Centre for Innovations and Technologies (CIT), ADSO Naturals Private Limited, Bangalore, India.'}]",Journal of liposome research,['10.1080/08982104.2020.1820521']
1900,32901672,"Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial.","OBJECTIVES


To evaluate the addition of a fourth antiemetic intervention in patients at high risk for postoperative nausea and vomiting (PONV).
METHODS


High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy were randomly allocated in one of two groups, oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg). Patients and caregivers were blinded to the group assignments. The primary efficacy endpoints included the incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period. ClinicalTrials.gov: NCT02431286.
RESULTS


One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group P. No patient presented with nausea or vomiting in the first 2 hours after surgery. From the 2nd to the 6th hour, the incidence of PONV was 8.33% in group A and 9.30% in group P. In the first 24 hours, the incidence of PONV was 27.08% in the group A and 20.93% in group P. From the 24th to the 48th hour, the incidence of PONV was 8.33% in group A and 13.95% in group P. There were no statistically significant differences in PONV between groups.
CONCLUSION


The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population. However, the incidence of PONV was reduced in relation to the general population.",2020,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"['One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group', 'High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy', 'patients at high risk for postoperative nausea and vomiting (PONV', 'after breast cancer surgery']","['oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg', 'Aprepitant plus palonosetron', 'antiemetic intervention']","['postoperative nausea and vomiting', 'PONV', 'incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period', 'incidence of PONV', 'nausea or vomiting']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C1331021', 'cui_str': 'aprepitant 80 MG'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",100.0,0.25619,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"[{'ForeName': 'Thiago Ramos', 'Initials': 'TR', 'LastName': 'Grigio', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Angela Maria', 'Initials': 'AM', 'LastName': 'Sousa', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Gabriel Guimarães Nunes', 'Initials': 'GGN', 'LastName': 'Magalhães', 'Affiliation': 'Campus Darcy Ribeiro, Faculdade Medicina, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Hazem Adel', 'Initials': 'HA', 'LastName': 'Ashmawi', 'Affiliation': 'Anestesiologia Experimental LIM-08, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Joaquim Edson', 'Initials': 'JE', 'LastName': 'Vieira', 'Affiliation': 'Cirurgia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1688']
1901,32719045,Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.,"OBJECTIVES


To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.
METHODS


From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.
RESULTS


At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.
CONCLUSIONS


A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.",2020,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","['patients with severe COVID-19-associated cytokine storm syndrome (CSS', 'From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100\u2009mg/L; ferritin >900\u2009µg/L; D-dimer >1500\u2009µg/L', 'comparison with a historic control group of patients who received supportive care only', 'Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age', 'patients with COVID-19-associated cytokine storm syndrome']","['interleukin-6 receptor blocker tocilizumab', 'methylprednisolone', 'glucocorticoids with or without tocilizumab', 'tocilizumab']","['≥2 stages of improvement on a 7-item WHO-endorsed scale', 'severe influenza pneumonia, or discharge from the hospital', 'hospital mortality and mechanical ventilation', 'symptoms of CSS and faced acute respiratory failure', 'invasive mechanical ventilation', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0155870', 'cui_str': 'Pneumonia and influenza'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3.0,0.16573,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ramiro', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands sofiaramiro@gmail.com.'}, {'ForeName': 'Rémy L M', 'Initials': 'RLM', 'LastName': 'Mostard', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Magro-Checa', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Christel M P', 'Initials': 'CMP', 'LastName': 'van Dongen', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dormans', 'Affiliation': 'Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Buijs', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Gronenschild', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Martijn D', 'Initials': 'MD', 'LastName': 'de Kruif', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'van Haren', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Kraaij', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Mathie P G', 'Initials': 'MPG', 'LastName': 'Leers', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Wong', 'Affiliation': 'Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218479']
1902,32914928,Interim Analysis of an Open-label Randomized Controlled Trial Evaluating Nasal Irrigations in Non-hospitalized Patients with COVID-19.,,2020,,['Non-hospitalized Patients with COVID-19'],[],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.0720634,,"[{'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Kimura', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Freeman', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Bronson C', 'Initials': 'BC', 'LastName': 'Wessinger', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Veerain', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Quanhu', 'Initials': 'Q', 'LastName': 'Sheng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Li Ching', 'Initials': 'LC', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Von Wahlde', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, Division of Microbiology and Infectious Disease, Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Naweed I', 'Initials': 'NI', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Turner', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}]",International forum of allergy & rhinology,['10.1002/alr.22703']
1903,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
1904,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
1905,32911138,"Short-term oral corticosteroids for initial treatment of moderate-to-severe persistent asthma: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND PURPOSE


The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.
METHODOLOGY


This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.
RESULTS


13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X 2  = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.
CONCLUSION


In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.",2020,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","['moderate-to-severe persistent asthma', '13 cases', 'Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic']","['Short-term oral corticosteroids', 'corticosteroid or placebo', 'placebo', 'ICS-LABA', 'Corticosteroid', 'Placebo']","['total control', 'control rates', 'rate of asthma control']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",13.0,0.251154,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","[{'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongming', 'Initials': 'D', 'LastName': 'Hua', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Overseas Chinese Hospital, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106126']
1906,32911210,Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
1907,32883555,Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial.,"BACKGROUND


This study evaluated the safety and immunogenicity of an investigational trivalent group B streptococcus (GBS) vaccine in US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk.
METHODS


This randomized, observer-blind, placebo-controlled trial administered one dose of trivalent GBS vaccine (n = 49) or placebo (n = 26) to healthy pregnant 18-40-year-old women at 24 0/7 -34 6/7  weeks' gestation. Women were enrolled from March 2014 to August 2015. Safety follow-up continued through postpartum day 180. Primary immunogenicity objectives were to evaluate serotype Ia/Ib/III-specific immunoglobulin G (IgG) levels in sera from women on day 1 (pre-vaccination), day 31, delivery and postpartum days 42 and 90, and from infants at birth (cord blood), days 42 and 90. Antibody transfer ratios (cord blood/maternal sera at delivery) and serotype-specific secretory immunoglobulin A (sIgA) and IgG in breast milk after delivery and on postpartum days 42 and 90 were evaluated. The planned sample size was not based on statistical assumptions for this descriptive study.
RESULTS


Baseline characteristics were similar between groups. Serious adverse events were reported for 16% of GBS-vaccinated women and 15% of their infants, and 15% of placebo recipients and 12% of their infants; none were fatal or deemed vaccine-related. Serotype-specific IgG geometric mean concentrations (GMCs) were 13-23-fold higher in vaccine vs placebo recipients on day 31 and persisted until postpartum day 90. Median antibody concentrations were substantially higher in women with detectable pre-vaccination antibody concentrations. Antibody transfer ratios in the vaccine group were 0.62-0.82. Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints.
CONCLUSIONS


Maternal immunization with the trivalent GBS vaccine in US women had a favorable safety profile, elicited antibodies that were transplacentally transferred and persisted in infants for a minimum of 3 months.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov, NCT02046148.",2020,"Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints.
","['US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk', 'sera from women on day 1 (pre-vaccination), day 31, delivery and postpartum days 42 and 90, and from infants at birth (cord blood), days 42 and 90', 'Women were enrolled from March 2014 to August 2015', 'pregnant women and their infants', ""n\xa0=\xa026) to healthy pregnant 18-40-year-old women at 24 0/7 -34 6/7  weeks' gestation""]","['placebo', 'trivalent GBS vaccine', 'investigational maternal trivalent group B streptococcus vaccine', 'investigational trivalent group B streptococcus (GBS) vaccine']","['Antibody transfer ratios', 'Safety and immunogenicity', 'Antibody transfer ratios (cord blood/maternal sera at delivery) and serotype-specific secretory immunoglobulin A (sIgA) and IgG in breast milk', 'Serious adverse events', 'Serotype-specific IgG geometric mean concentrations (GMCs', 'Median antibody concentrations', 'serotype Ia/Ib/III-specific immunoglobulin G (IgG) levels', 'Infant IgG GMCs and breast milk sIgA GMCs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444974', 'cui_str': 'Ia'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.638463,"Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints.
","[{'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC, USA. Electronic address: Geeta.Swamy@duke.edu.'}, {'ForeName': 'Torri D', 'Initials': 'TD', 'LastName': 'Metz', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO, USA. Electronic address: torri.metz@hsc.utah.edu.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, TN, USA. Electronic address: kathryn.edwards@vumc.org.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Soper', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: soperde@musc.edu.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Beigi', 'Affiliation': ""UPMC Magee-Women's Hospital, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: beigrh@mail.magee.edu.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: jcampbel@som.umaryland.edu.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Grassano', 'Affiliation': 'GSK, Siena, Italy. Electronic address: luca.x.grassano@gsk.com.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Buffi', 'Affiliation': 'GSK, Siena, Italy. Electronic address: giada.x.buffi@gsk.com.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Dreisbach', 'Affiliation': 'GSK, Marburg, Germany. Electronic address: annettedreisbach@gmx.de.'}, {'ForeName': 'Immaculada', 'Initials': 'I', 'LastName': 'Margarit', 'Affiliation': 'GSK, Siena, Italy. Electronic address: immaculada.x.margarit-y-ros@gsk.com.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Karsten', 'Affiliation': 'GSK, Marburg, Germany. Electronic address: annette.x.karsten@gsk.com.'}, {'ForeName': 'Ouzama', 'Initials': 'O', 'LastName': 'Henry', 'Affiliation': 'GSK, Rockville, MD, USA. Electronic address: ouzama.n.henry@gsk.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lattanzi', 'Affiliation': 'GSK, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com.'}, {'ForeName': 'Zourab', 'Initials': 'Z', 'LastName': 'Bebia', 'Affiliation': 'GSK, Rockville, MD, USA. Electronic address: zourab.x.bebia@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2020.08.056']
1908,32905673,High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation.,"BACKGROUND


When patients with a tracheostomy tube reach a stage in their care at which decannulation appears to be possible, it is common practice to cap the tracheostomy tube for 24 hours to see whether they can breathe on their own. Whether this approach to establishing patient readiness for decannulation leads to better outcomes than one based on the frequency of airway suctioning is unclear.
METHODS


In five intensive care units (ICUs), we enrolled conscious, critically ill adults who had a tracheostomy tube; patients were eligible after weaning from mechanical ventilation. In this unblinded trial, patients were randomly assigned either to undergo a 24-hour capping trial plus intermittent high-flow oxygen therapy (control group) or to receive continuous high-flow oxygen therapy with frequency of suctioning being the indicator of readiness for decannulation (intervention group). The primary outcome was the time to decannulation, compared by means of the log-rank test. Secondary outcomes included decannulation failure, weaning failure, respiratory infections, sepsis, multiorgan failure, durations of stay in the ICU and hospital, and deaths in the ICU and hospital.
RESULTS


The trial included 330 patients; the mean (±SD) age of the patients was 58.3±15.1 years, and 68.2% of the patients were men. A total of 161 patients were assigned to the control group and 169 to the intervention group. The time to decannulation was shorter in the intervention group than in the control group (median, 6 days [interquartile range, 5 to 7] vs. 13 days [interquartile range, 11 to 14]; absolute difference, 7 days [95% confidence interval, 5 to 9]). The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group. Other secondary outcomes were similar in the two groups.
CONCLUSIONS


Basing the decision to decannulate on suctioning frequency plus continuous high-flow oxygen therapy rather than on 24-hour capping trials plus intermittent high-flow oxygen therapy reduced the time to decannulation, with no evidence of a between-group difference in the incidence of decannulation failure. (REDECAP ClinicalTrials.gov number, NCT02512744.).",2020,"The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group.","['161 patients were assigned to the control group and 169 to the intervention group', '330 patients; the mean (±SD) age of the patients was 58.3±15.1 years, and 68.2% of the patients were men', 'critically ill adults who had a tracheostomy tube; patients were eligible after weaning from mechanical ventilation']","['High-Flow Oxygen with Capping or Suctioning', '24-hour capping trial plus intermittent high-flow oxygen therapy (control group) or to receive continuous high-flow oxygen therapy with frequency of suctioning being the indicator of readiness for decannulation (intervention group']","['decannulation failure, weaning failure, respiratory infections, sepsis, multiorgan failure, durations of stay in the ICU and hospital, and deaths in the ICU and hospital', 'duration of stay', 'time to decannulation', 'incidence of decannulation failure', 'incidence of pneumonia and tracheobronchitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0376249', 'cui_str': 'Frequency'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1868713', 'cui_str': 'Weaning failure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0040586', 'cui_str': 'Tracheobronchitis'}]",330.0,0.138735,"The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group.","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Hernández Martínez', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Luisa', 'Initials': 'ML', 'LastName': 'Rodriguez', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Concepción', 'Initials': 'MC', 'LastName': 'Vaquero', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Joan-Ramon', 'Initials': 'JR', 'LastName': 'Masclans', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Roca', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Colinas', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'de Pablo', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Del-Carmen', 'Initials': 'MD', 'LastName': 'Espinosa', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garcia-de-Acilu', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Climent', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cuena-Boy', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}]",The New England journal of medicine,['10.1056/NEJMoa2010834']
1909,32905674,BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A.,"BACKGROUND


Factor VIII replacement products have improved the care of patients with hemophilia A, but the short half-life of these products affects the patients' quality of life. The half-life of recombinant factor VIII ranges from 15 to 19 hours because of the von Willebrand factor chaperone effect. BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels. Data are lacking on the safety and pharmacokinetics of single-dose BIVV001.
METHODS


In this phase 1-2a open-label trial, we consecutively assigned 16 previously treated men (18 to 65 years of age) with severe hemophilia A (factor VIII activity, <1%) to receive a single intravenous injection of recombinant factor VIII at a dose of 25 IU per kilogram of body weight (lower-dose group) or 65 IU per kilogram (higher-dose group). This injection was followed by a washout period of at least 3 days. The patients then received a single intravenous injection of BIVV001 at the same corresponding dose of either 25 IU or 65 IU per kilogram. Adverse events and pharmacokinetic measurements were assessed.
RESULTS


No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001. The geometric mean half-life of BIVV001 was three to four times as long as that of recombinant factor VIII (37.6 hours vs. 9.1 hours in the lower-dose group and 42.5 vs. 13.2 hours in the higher-dose group); the area under the curve (AUC) for product exposure was six to seven times as great in the two dose groups (4470 hours vs. 638 hours × IU per deciliter in the lower-dose group and 12,800 hours vs. 1960 hours × IU per deciliter in the higher-dose group). After the injection of BIVV001 in the higher-dose group, the mean factor VIII level was in the normal range (≥51%) for 4 days and 17% at day 7, which suggested the possibility of a weekly interval between treatments.
CONCLUSIONS


In a small, early-phase study involving men with severe hemophilia A, a single intravenous injection of BIVV001 resulted in high sustained factor VIII activity levels, with a half-life that was up to four times the half-life associated with recombinant factor VIII, an increase that could signal a new class of factor VIII replacement therapy with a weekly treatment interval. No safety concerns were reported during the 28-day period after administration. (Funded by Sanofi and Sobi; ClinicalTrials.gov number, NCT03205163.).",2020,No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001.,"['Hemophilia A', 'men with severe hemophilia A', '16 previously treated men (18 to 65 years of age) with severe hemophilia A (factor VIII activity, <1']",['recombinant factor VIII'],"['Adverse events and pharmacokinetic measurements', 'mean factor VIII level', 'hypersensitivity or anaphylaxis events', 'sustained factor VIII activity levels']","[{'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200399', 'cui_str': 'Factor VIII assay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0608014,No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001.,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Konkle', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Shapiro', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Doris V', 'Initials': 'DV', 'LastName': 'Quon', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Staber', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Kulkarni', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Ekta S', 'Initials': 'ES', 'LastName': 'Chhabra', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Poloskey', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Rice', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Katragadda', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Fruebis', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Benson', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}]",The New England journal of medicine,['10.1056/NEJMoa2002699']
1910,32912260,Leveraging family dynamics to increase the effectiveness of incentives for physical activity: the FIT-FAM randomized controlled trial.,"BACKGROUND


Insufficient physical activity is a global public health concern. Research indicates incentives can increase physical activity levels of children but has not tested whether incentives targeted at children can be leveraged to increase physical activity levels of their parents. This study evaluates whether a novel incentive design linking children's incentives to both their and their parent's physical activity levels can increase parent's physical activity.
METHODS


We conducted a two-arm, parallel, open-labelled randomized controlled trial in Singapore where parent-child dyads were randomly assigned to either (1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based). Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65 years, and with a participating child aged 7-11 years. Parent-child dyads were randomized within strata (self-reported low vs high weekly physical activity) into study arms in a 1:1 ratio. Participants were given activity trackers to assess daily steps. The outcome of interest was the between-arm difference in the change from baseline in parent's mean steps/day measured by accelerometry at months 6 and 12 (primary endpoint).
RESULTS


Overall, 159 and 157 parent-child dyads were randomized to the child-based or family-based arms, respectively. Outcomes were evaluated on an intent-to-treat basis. At month 6, there was a 613 steps/day (95% CI: 54-1171) differential in favour of family-based parents. At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
CONCLUSIONS


Our findings suggest that novel incentive designs that take advantage of group dynamics may be effective. However, in this design, the effectiveness of the family-based incentive to increase parent's physical activity was not sustained through one year.
TRIAL REGISTRATION


NCT02516345 (ClinicalTrials.gov) registered on August 5, 2015.",2020,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","['Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65\u2009years, and with a participating child aged 7-11\u2009years', 'Singapore where parent-child dyads', '159 and 157 parent-child dyads', 'Parent-child dyads']","[""1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based""]","[""parent's physical activity"", 'physical activity levels']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.111529,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","[{'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Robyn Su May', 'Initials': 'RSM', 'LastName': 'Lim', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Dianne Stanton', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Evenson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01018-2']
1911,32912410,[Study of multimodal monitoring in neurocritical care patients].,"OBJECTIVE


To explore the significance of multimodal monitoring in the monitoring and treatment of neurocritical care patients.
METHODS


104 neurocritical care patients admitted to the department of Critical Care Medicine of Fujian Provincial Hospital from March 2019 to January 2020 were enrolled. Patients were randomly assigned into two groups, with 52 in each group. In the routine monitoring treatment group, heart rate, blood pressure, respiratory rate and the changes in consciousness and pupils were monitored after operation. The patients were treated with routine medicine to reduce intracranial pressure (ICP), maintain proper cerebral perfusion pressure (CPP), balance fluid intake and output, and maintain the airway clear. Patients in the multimodal monitoring treatment group were treated with invasive ICP monitoring, ultrasound to assess brain structure, ultrasound to measure optic nerve sheath diameter (ONSD), transcranial color doppler (TCCD), internal jugular venous blood oxygen saturation monitoring, near-infrared spectroscopy (NIRS), non-invasive cerebral blood oxygen saturation monitoring and quantitative electroencephalogram monitoring. According to the monitoring results, the patients were given targeted treatment with the goal of controlling ICP and improving brain metabolism. The length of intensive care unit (ICU) stay, the incidences of neurological complications (secondary cerebral infarction, cerebral hemorrhage, high intracranial pressure, etc.), and the incidences of poor prognosis [6 months after the onset of Glasgow outcome score (GOS) 1 to 3] were compared between the two groups. Spearman rank correlation analysis of the correlation between invasive ICP and the ICP value which was calculated by TCCD. The receiver operating characteristic (ROC) curve of invasive ICP and pulsatility index of middle cerebral artery (PI MCA ) were used to predict poor prognosis.
RESULTS


The length of ICU stay in the multimodal monitoring treatment group was significantly shorter than that of the routine monitoring treatment group (days: 6.27±3.81 vs. 9.61±5.09, P < 0.01), and the incidence of neurological complications was significantly lower than that in the routine monitoring treatment group (9.62% vs. 25.00%, P < 0.05). In the multimodal monitoring treatment group, 37 cases had a good prognosis and 15 cases had a poor prognosis, while the routine monitoring treatment group had a good prognosis in 27 cases and a poor prognosis in 25 cases. The incidence of poor prognosis in the multimodal monitoring treatment group was lower than that of the routine monitoring treatment group (28.85% vs. 48.08%, P < 0.05). In the multimodal monitoring treatment group, the invasive ICP and PI MCA  of patients with good prognosis were significantly lower than those of patients with poor prognosis [invasive ICP (mmHg, 1 mmHg = 0.133 kPa): 16 (12, 17) vs. 22 (20, 24), PI MCA : 0.90±0.33 vs. 1.39±0.58, both P < 0.01]. There was no significant difference in resistance index of the middle cerebral artery (RI MCA ) between the good prognosis group and the poor prognosis group (0.63±0.12 vs. 0.66±0.15, P > 0.05). There was a positive correlation between the invasive ICP and the ICP value which was calculated by TCCD (r = 0.767, P < 0.001). ROC curve analysis showed that the area under ROC curve (AUC) of invasive ICP for poor prognosis prediction was 0.906, the best cut-off value was ≥ 18 mmHg, the sensitivity was 86.49%, and the specificity was 86.67%. The AUC of PIMCA for poor prognosis prediction was 0.759, the best cut-off value was ≥ 1.12, the sensitivity was 81.08%, and the specificity was 60.00%. The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
CONCLUSIONS


Comprehensive analysis of multimodal monitoring indicators for neurocritical care patients to guide clinical treatment can reduce the length of hospital stay, and reduce the risk of neurosurgery complications and disability; invasive ICP can predict poor prognosis of neurocritical care patients.",2020,"The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
","['neurocritical care patients', '104 neurocritical care patients admitted to the department of Critical Care Medicine of Fujian Provincial Hospital from March 2019 to January 2020 were enrolled']","['invasive ICP monitoring, ultrasound to assess brain structure, ultrasound to measure optic nerve sheath diameter (ONSD), transcranial color doppler (TCCD), internal jugular venous blood oxygen saturation monitoring, near-infrared spectroscopy (NIRS), non-invasive cerebral blood oxygen saturation monitoring and quantitative electroencephalogram monitoring', 'routine medicine']","['incidence of neurological complications', 'resistance index of the middle cerebral artery (RI MCA ', 'AUC of invasive ICP', 'length of hospital stay', 'length of ICU stay', 'brain metabolism', 'receiver operating characteristic (ROC) curve of invasive ICP and pulsatility index of middle cerebral artery (PI MCA ', 'invasive ICP and PI MCA  of patients with good prognosis', 'incidence of poor prognosis', 'intracranial pressure (ICP), maintain proper cerebral perfusion pressure (CPP), balance fluid intake and output, and maintain the airway clear', 'length of intensive care unit (ICU) stay, the incidences of neurological complications (secondary cerebral infarction, cerebral hemorrhage, high intracranial pressure, etc.), and the incidences of poor prognosis', 'heart rate, blood pressure, respiratory rate and the changes in consciousness and pupils']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0150260', 'cui_str': 'Intracranial pressure monitoring regime'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]",,0.0172345,"The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
","[{'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou 350001, Fujian, China. Corresponding author: Chen Han, Email: baojr2@163.com.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Rongguo', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jingqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yingrui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200130-00148']
1912,32918512,Physicians' very brief (30-sec) intervention for smoking cessation on 13 671 smokers in China: a pragmatic randomized controlled trial.,"BACKGROUND AND AIMS


Three to 10 minutes of smoking cessation advice by physicians is effective to increase quit rates, but is not routinely practised. We examined the effectiveness of physicians' very brief (approximately 30 sec) smoking cessation intervention on quit rates among Chinese outpatient smokers.
DESIGN


A pragmatic, open-label, individually randomized controlled trial.
SETTING


Seventy-two medical outpatient departments of hospitals and/or community health centers in Guangdong, China.
PARTICIPANTS


Chinese adults who were daily cigarette smokers (n = 13 671, 99% males) were invited by their physician to participate during outpatient consultation. Smokers who were receiving smoking cessation treatment or were judged to need specialist treatment for cessation were excluded.
INTERVENTIONS


The intervention group (n = 7015) received a 30-sec intervention including physician's very brief advice, a leaflet with graphic warnings and a card with contact information of available cessation services. The control group (n = 6656) received a very brief intervention on consuming vegetables and fruit. A total of 3466 participants in the intervention group were further randomized to receive a brief booster advice from trained study personnel via telephone 1 month following their doctor visit.
MEASUREMENTS


The primary outcome was self-reported 7-day point prevalence abstinence (PPA) in the intervention and control groups at the 12-month follow-up. Secondary outcomes included self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up.
FINDINGS


By intention-to-treat, the intervention (versus control) group had greater self-reported 7-day abstinence [9.1 versus 7.8%, odds ratio (OR) = 1.14, 95% confidence interval (CI) = 1.03-1.26, P = 0.008] and 30-day abstinence (8.0 versus 6.9%, OR = 1.14, 95% CI = 1.03-1.27, P = 0.01) at 12-month follow-up. The effect size increased when only participants who received the intervention from compliant physicians were included (7-day PPA, OR = 1.42, 95% CI = 1.11-1.74). The group difference in biochemically validated abstinence was small (0.8 versus 0.8%, OR = 1.00, 95% CI = 0.71-1.42, P = 0.99).
CONCLUSION


A 30-sec smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%), and should be feasible to provide in most settings and delivered by all health-care professionals.",2020,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"['13,671 smokers in China', 'Chinese outpatient smokers', '3,466 participants in the intervention group', 'mainly male smokers', 'Smokers who were receiving smoking cessation treatment or were judged to needed specialist treatment for cessation were excluded', 'Seventy-two medical outpatient departments of hospitals', 'Chinese adults who were daily cigarette smokers (N = 13,671, 99% males) were invited by their physician to participate during outpatient consultation', 'and/or community health centers in Guangdong, China']","[""physicians' very brief (about 30 seconds) smoking cessation intervention"", '30-second smoking cessation intervention', 'very brief intervention on consuming vegetables and fruits', 'brief booster advice from trained study personnel through telephone one month following their doctor visit', ""30-second intervention including physician's very brief advice, a leaflet with graphic warnings, and a card with contact information of available cessation services""]","['quit rates', '30-day abstinence', 'self-reported abstinence', 'self-reported 7-day point prevalence abstinence', 'effect size', 'self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up', 'greater self-reported 7-day abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",3466.0,0.0775531,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, Grossman School of Medicine, New York University, New York, NY, USA.'}, {'ForeName': 'Chao Qiang', 'Initials': 'CQ', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Run Sen', 'Initials': 'RS', 'LastName': 'Zhuang', 'Affiliation': 'Shenzhen Health Education and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Wen Hui', 'Initials': 'WH', 'LastName': 'Gao', 'Affiliation': 'Shenzhen Health Education and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Medical University Second Affiliated Hospital, Guangzhou, China.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Lu', 'Affiliation': 'Traditional Chinese Medical Hospital of Huangpu, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Shenzhen Bao'an District Songgang People's Hospital, Hongqiaotou Community Health Service Center, Shenzhen, China.""}, {'ForeName': 'Jun Feng', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': 'The Fifth Affiliated Hospital of Sun Yat-sen University, Zhongshang, China.'}, {'ForeName': 'Yi Sheng', 'Initials': 'YS', 'LastName': 'Lai', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jun Sheng', 'Initials': 'JS', 'LastName': 'Sun', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jiu Chang', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': ""Shenzhen Bao'an District Fuyong Hospital, Shenzhen, China.""}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ""Division of Endocrinology, Shenzhen Bao'an District People's Hospital, Shenzhen, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Jing Ying', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Shenzhen Longgang District Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiu Yan', 'Initials': 'XY', 'LastName': 'Ou', 'Affiliation': ""ZhongShan City People's Hospital, ZhongShan, China.""}, {'ForeName': 'Liu Qing', 'Initials': 'LQ', 'LastName': 'Liu', 'Affiliation': ""Longhua District People's Hospital Yansong Community Center, Shenzhen, China.""}, {'ForeName': 'Zhuang Hong', 'Initials': 'ZH', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College Guan Bu Zhai Mei Healthcare Station, Shantou, China.'}, {'ForeName': 'Sai Yin', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng Hua', 'Initials': 'SH', 'LastName': 'Su', 'Affiliation': 'Health Care Center for Cadre of Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Wei Hua', 'Initials': 'WH', 'LastName': 'Zhu', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Guangzhou No. 12 Hospital, Guangzhou Guangdong Province, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ""Guangzhou\xa0First Municipal People's Hospital,\xa0Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kar Keung', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15262']
1913,32915972,Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS.,"The treatment of older, unfit patients with acute myeloid leukemia (AML) is challenging. Based on preclinical data of Bruton tyrosine kinase expression/phosphorylation and ibrutinib cytotoxicity in AML blasts, we conducted a randomized phase 2 multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial). In total, 144 eligible patients were randomly (1:1) assigned to either 10-day decitabine combined with ibrutinib (560 mg; sequentially given, starting the day after the last dose of decitabine) (n = 72) or to 10-day decitabine (n = 72). The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms. In the decitabine plus ibrutinib arm, 41% reached complete remission/complete remission with incomplete hematologic recovery (CR/CRi), the median overall survival (OS) was 11 months, and 2-year OS was 27%; these findings compared with 50% CR/CRi, median OS of 11.5 months, and 2-year OS of 21% for the decitabine group (not significant). Extensive molecular profiling at diagnosis revealed that patients with STAG2, IDH2, and ASXL1 mutations had significantly lower CR/CRi rates, whereas patients with mutations in TP53 had significantly higher CR/CRi rates. Furthermore, multicolor flow cytometry revealed that after 3 cycles of treatment, 28 (49%) of 57 patients with available bone marrow samples had no measurable residual disease. In this limited number of cases, measurable residual disease revealed no apparent impact on event-free survival and OS. In conclusion, the addition of ibrutinib does not improve the therapeutic efficacy of decitabine. This trial was registered at the Netherlands Trial Register (NL5751 [NTR6017]) and has EudraCT number 2015-002855-85.",2020,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","['144 eligible patients', 'older, unfit patients with acute myeloid leukemia (AML', 'unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial', 'older patients with AML and higher risk MDS']","['ibrutinib to 10-day decitabine', '10-day decitabine combined with ibrutinib', 'decitabine', '10-day decitabine', 'Ibrutinib added to 10-day decitabine']","['tolerability and efficacy', 'therapeutic efficacy of decitabine', '2-year OS', 'complete remission/complete remission with incomplete hematologic recovery (CR/CRi', 'number of adverse events', 'median overall survival (OS', 'CR/CRi rates']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",144.0,0.206533,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","[{'ForeName': 'Gerwin', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Chitu', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology, Meander Hospital Amersfoort, Amersfoort, The Netherlands.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stussi', 'Affiliation': 'Department of Hematology, Ospedale Regionale, Bellinzona, Switzerland.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Griskevicius', 'Affiliation': 'Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Valk', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjan A', 'Initials': 'AA', 'LastName': 'van de Loosdrecht', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Breems', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg/Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van Lammeren-Venema', 'Affiliation': 'Department of Hematology, Hagaziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'van Zeventer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Hematology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'Department of Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Hematology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Markus G', 'Initials': 'MG', 'LastName': 'Manz', 'Affiliation': 'Department of Medical Oncology and Hematology, Universitätsspital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Söhne', 'Affiliation': 'Department of Hematology, Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Rien', 'Initials': 'R', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Hematology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Department of Hematology, AZ Delta Roeselare, Roeselare, Belgium.'}, {'ForeName': 'Marjolein W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Legdeur', 'Affiliation': 'Department of Hematology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Lidwine', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Hematology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Division of Hematology, University Hospital Genève and Faculty of Medicine, University of Genève, Genève, Switzerland; and.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Ammatuna', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Service and Central Laboratory of Hematology, Department of Oncology and Department of Laboratory Medicine and Pathology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}]",Blood advances,['10.1182/bloodadvances.2020002846']
1914,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
1915,32920321,Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial.,"INTRODUCTION


Cerebellar ataxia remains a neurological symptom orphan of treatment interventions, despite being prevalent and incapacitating. We aimed to study, in a double-blind design, whether cerebellar modulation could improve ataxia.
METHODS


We included patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia. Patients received five sessions each of sham and active cerebellar 1 Hz deep repetitive transcranial magnetic stimulation in randomized order. Our primary outcome was the decrease in the Scale for the Assessment and Rating of Ataxia when comparing phases (active x sham). Secondary outcomes measures included the International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales. This study was registered at clinicaltrials.gov (protocol NCT03213106).
RESULTS


Twenty-four patients aged 29-74 years were included in our trial. After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002]. The International Cooperative Ataxia Rating Scale score also improved after active stimulation versus sham [median (interquartile range) of 29.0 (21.0, 43.5) versus 32.8 (22.0, 47.0); p = 0.005]. Other secondary outcomes were not significantly modified by stimulation. No patient presented severe side effects, and nine presented mild and self-limited symptoms.
CONCLUSIONS


Our protocol was safe and well-tolerated. These findings suggest that cerebellar modulation may improve ataxic symptom and provide reassurance about safety for clinical practice.",2020,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","['ataxias', 'Twenty-four patients aged 29-74 years', 'patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia']","['Hz deep repetitive transcranial magnetic stimulation', 'cerebellar transcranial magnetic stimulation']","['International Cooperative Ataxia Rating Scale score', 'ataxia', 'ataxic symptom', 'severe side effects', 'International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales', 'safe and well-tolerated', 'Scale for the Assessment and Rating of Ataxia', 'Scale for the Assessment and Rating of Ataxia score']","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4760996', 'cui_str': 'International cooperative ataxia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}]",24.0,0.653213,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'França', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'de Andrade', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Silva', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Functional Neurosurgery Division, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens G', 'Initials': 'RG', 'LastName': 'Cury', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil. Electronic address: rubens_cury@usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.001']
1916,32920476,A brief cognitive behavioural intervention is cost-effective for primary care patients with medically unexplained physical symptoms compared to usual care.,"OBJECTIVE


To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care.
METHODS


We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves.
RESULTS


Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores.
CONCLUSION


Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs.",2020,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","['patients with MUPS', 'patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care', 'primary care patients with medically unexplained physical symptoms compared to usual care']",['cognitive behavioural intervention'],"['cost-effectiveness', 'quality-adjusted life-years (QALYs', 'RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness planes and cost-effectiveness acceptability curves', 'Mean total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.101801,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sitnikova', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands. Electronic address: e.sitnikova@amsterdamumc.nl.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'EuroQol Research Foundation, Marten Meesweg 107, 3068 AV Rotterdam, the Netherlands.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Trimbos Institute, Da Costakade 45, 3521 VS Utrecht, the Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Harm W J', 'Initials': 'HWJ', 'LastName': 'van Marwijk', 'Affiliation': 'Brighton and Sussex Medical School, 94 N - S Rd, Falmer, Brighton BN1 9PX, United Kingdom.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110217']
1917,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
1918,32921503,Reduced mortality risk in malnourished hospitalized older adult patients with COPD treated with a specialized oral nutritional supplement: Sub-group analysis of the NOURISH study.,"BACKGROUND


Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD) have an elevated risk of readmission and mortality.
OBJECTIVE


Post-hoc, sub-group analysis from the NOURISH study cohort examined the effect of a high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB) in malnourished, hospitalized older adults with COPD and to identify predictors of outcomes.
METHODS


The NOURISH study (n = 652) was a multicenter, randomized, placebo-controlled, double-blind trial. The COPD subgroup (n = 214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65 y), with admission diagnosis of COPD who received either standard-of-care plus HP-HMB (n = 109) or standard-of-care and a placebo supplement (n = 105) prescribed 2 servings/day from within 3 days of hospital admission (baseline) and up to 90 days after discharge. The primary study outcome was a composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time. Categorical outcomes were analyzed using Cochran-Mantel-Haenszel tests, longitudinal data by repeated measures analysis of covariance; and changes from baseline by analysis of covariance. p-values ≤ 0.05 were considered statistically significant. Multivariate logistic regression was used to model predictors of the primary outcome and components.
RESULTS


In patients with COPD, 30, 60, and 90-day hospital readmission rate did not differ, but in contrast, 30, 60, and 90-day mortality risk was approximately 71% lower with HP-HMB supplementation relative to placebo (1.83%, 2.75%, 2.75% vs. 6.67%, 9.52% and 10.48%, p = 0.0395, 0.0193, 0.0113, resp.). In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. -0.01 kg, p < 0.05) and, improvements in blood nutritional biomarker concentrations. The multivariate logistic regression predictors of the death, readmission or composite endpoints in these COPD patients showed that participants who were severely malnourished (p = 0.0191) and had a Glasgow prognostic score (GPS) Score of 1 or 2 had statistically significant odds of readmission or death (p = 0.0227).
CONCLUSIONS


Among malnourished, hospitalized patients with COPD, supplementation with HP-HMB was associated with a markedly decreased mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers within a 90-day period after hospital discharge. This post-hoc, subgroup analysis highlights the importance of early identification of nutritional risk and administration of high-protein ONS in older, malnourished patients with COPD after hospital admission and continuing after hospital discharge.",2020,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","['COPD subgroup (n\xa0=\xa0214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65\xa0y), with admission diagnosis of COPD who received either', 'malnourished, hospitalized older adults with COPD', 'older, malnourished patients with COPD after hospital admission and continuing after hospital discharge', 'malnourished hospitalized older adult patients with COPD', 'malnourished, hospitalized patients with COPD, supplementation with HP-HMB', 'Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD']","['high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB', 'placebo', 'standard-of-care plus HP-HMB (n\xa0=\xa0109) or standard-of-care and a placebo supplement']","['mortality risk', 'composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time', 'hospital discharge', '90-day hospital readmission rate', 'GPS Score', 'handgrip strength', 'readmission or death', '90-day mortality risk', 'body weight', 'death, readmission or composite endpoints', 'mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers', 'blood nutritional biomarker concentrations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.272438,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","[{'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'Texas A&M University, College Station, TX, USA. Electronic address: nep.deutz@ctral.org.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Matheson', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Matarese', 'Affiliation': 'Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Tappenden', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nelson', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Refaat', 'Initials': 'R', 'LastName': 'Hegazi', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA; Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Satya S', 'Initials': 'SS', 'LastName': 'Jonnalagadda', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.031']
1919,32930958,Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer.,"Apalutamide (Erleada ® ) is an oral selective androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC). In a multinational, phase III study (TITAN) in this patient population, the addition of apalutamide (240 mg once daily) to androgen deprivation therapy (ADT) significantly improved median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining health-related quality of life (HR-QOL) and not substantially differing from placebo plus ADT in safety. Although mature OS data are awaited with interest, the addition of apalutamide to ADT extends the treatment options available for standard of care in adult men with mCSPC.",2020,It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC).,"['Metastatic Castration-Sensitive Prostate Cancer', 'adult men with metastatic castration-sensitive prostate cancer (mCSPC', 'adult men with mCSPC']","['androgen deprivation therapy (ADT', 'USA', 'Apalutamide (Erleada ® ', 'Apalutamide']","['median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining health-related quality of life (HR-QOL']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4551002', 'cui_str': 'Erleada'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.11877,It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC).,"[{'ForeName': 'Sheridan M', 'Initials': 'SM', 'LastName': 'Hoy', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01401-0']
1920,32931320,"Retraction of:  Aceves-Martins M, Llauradó E, Tarro L, et al: A School-Based, Peer-Led, Social Marketing Intervention to Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study): A Parallel Cluster Randomized Controlled Study [Child Obes 2017;13:300-313; doi: 10.1089/chi.2016.0216].",,2020,,"[""Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study"", 'Child Obes 2017;13:300-313']",['Social Marketing Intervention'],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517707', 'cui_str': '313'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0292577,,[],Childhood obesity (Print),['10.1089/chi.2016.0216.retract']
1921,32916347,"Neuromuscular Electrical Stimulation for Venous Thromboembolism Prophylaxis and Its Effects on Somatosensory-Evoked Potentials: A Pretrial Study of a New, U.S. Food and Drug Administration-Approved Device.","BACKGROUND


Neuromuscular electrical stimulation (NMES) has emerged as a viable alternative for venous thromboembolism prophylaxis. Electrical stimulation of the peroneal nerve using NMES may potentially interfere with somatosensory-evoked potential (SSEP) acquisition. This feasibility study evaluates a NMES device and its effect on SSEP acquisition as an initial step in a randomized clinical trial to assess NMES for intraoperative venous thromboembolism prophylaxis.
METHODS


Healthy volunteers underwent SSEP testing during NMES in an outpatient setting. Concurrently, SSEP recordings of the posterior tibial nerve with stimulation at each ankle were obtained in 3 conditions: sham, NMES in place but inactive; ipsi, NMES active on leg ipsilateral to SSEP acquisition; and contra, NMES active on the leg contralateral to SSEP acquisition. Nonparametric statistical methods, including repeated measures, were used for data analysis.
RESULTS


Stimulation intensities on the left, right, and bilaterally did not differ (P ≥ 0.20). Strong positive correlations were noted between the ipsilateral geko stimulus pulse width and ipsilateral SSEP stimulation intensities (left: r s  = 0.866, P = 0.001; right: r s  = 0.877, P = 0.001). Women required significantly greater pulse width settings than men (P = 0.01). Finally, visual inspection of waveforms, as used during dynamic IONM, did not show any significant variations of P37 cortical waveforms during NMES.
CONCLUSIONS


As a preliminary step to testing NMES intraoperatively for venous thromboembolism prophylaxis, interference with SSEP acquisition was investigated in the outpatient laboratory setting. Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.",2020,"Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.","['Healthy volunteers underwent SSEP testing during NMES in an outpatient setting', 'healthy volunteers']","['Neuromuscular electrical stimulation (NMES', 'NMES', 'NMES device', 'Neuromuscular electrical stimulation']","['P37 cortical waveforms', 'P37 cortical latencies', 'ipsilateral geko stimulus pulse width and ipsilateral SSEP stimulation intensities', 'pulse width settings']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1611473', 'cui_str': 'CCNH protein, human'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.145507,"Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bohl', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Newell', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Shvarts', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona, USA; Department of Neurology, University of Arizona College of Medicine, Phoenix, Arizona, USA; Department of Neurology, Creighton University School of Medicine, Phoenix, Arizona, USA.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona, USA; Department of Neurology, University of Arizona College of Medicine, Phoenix, Arizona, USA; Department of Neurology, Creighton University School of Medicine, Phoenix, Arizona, USA. Electronic address: Neuropub@barrowneuro.org.'}]",World neurosurgery,['10.1016/j.wneu.2020.09.025']
1922,32919056,Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest.,"Episodic memory depends decisively on the hippocampus and the parahippocampal gyrus, brain structures that are also prone to exercise-induced neuroplasticity and cognitive improvement. We conducted a randomized controlled trial to investigate the effects of a high-intensity exercise program in twenty-two men resting in bed for 60 days on episodic memory and its neuronal basis. All participants were exposed to 60 days of uninterrupted bed rest. Eleven participants were additionally assigned to a high-intensity interval training that was performed five to six times weekly for 60 days. Episodic memory and its neural basis were determined four days prior to and on the 58th day of bed rest using functional magnetic resonance imaging (fMRI). We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly. These findings indicate a higher neuronal efficiency in the training group during memory encoding and retrieval and may suggest a dysfunctional mechanism in the non-exercising bed rest group induced by two months of physical inactivity. Our results provide further support for the modulating effects of physical exercise and adverse implications of a sedentary lifestyle and bedridden patients.",2020,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"['Eleven participants', 'twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis']",['high-intensity exercise program'],"['BOLD signal', 'neuronal efficiency', 'brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0382575,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Friedl-Werner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Université de Normandie, INSERM U 1075 COMETE, 14000 Caen, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brauns', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Gunga', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany; Max-Planck-Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, 14195 Berlin, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Stahn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Unit of Experimental Psychiatry, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: astahn@pennmedicine.upenn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117359']
1923,32919076,"Antibiotics versus no therapy in kidney transplant recipients with asymptomatic bacteriuria (BiRT): a pragmatic, multicentre, randomized, controlled trial.","OBJECTIVES


Many transplant physicians screen for and treat asymptomatic bacteriuria (ASB) during post-kidney-transplant surveillance. We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
METHODS


We performed this multicentre, randomized, open-label trial in kidney transplant recipients who had ASB and were ≥2 months post-transplantation. We randomly assigned participants to receive antibiotics or no therapy. The primary outcome was the incidence of symptomatic UTI over the subsequent 12 months.
RESULTS


One hundred and ninety-nine kidney transplant recipients with ASB were randomly assigned to antibiotics (100 participants) or no therapy (99 participants). There was no significant difference in the occurrence of symptomatic UTI between the antibiotic and no-therapy groups (27%, 27/100 versus 31%, 31/99; univariate Cox model: hazard ratio 0.83, 95%CI: 0.50-1.40; log-rank test: p 0.49). Over the 1-year study period, antibiotic use was five times higher in the antibiotic group than in the no-therapy group (30 antibiotic days/participant, interquartile range 20-41, versus 6, interquartile range 0-15, p < 0.001). Overall, 155/199 participants (78%) had at least one further episode of bacteriuria during the follow-up. Compared with the participant's baseline episode of ASB, the second episode of bacteriuria was more frequently caused by bacteria resistant to clinically relevant antibiotics (ciprofloxacin, cotrimoxazole, third-generation cephalosporin) in the antibiotic group than in the no-therapy group (18%, 13/72 versus 4%, 3/83, p 0.003).
CONCLUSIONS


Applying a screen-and-treat strategy for ASB does not reduce the occurrence of symptomatic UTI in kidney transplant recipients who are more than 2 months post-transplantation. Furthermore, this strategy increases antibiotic use and promotes the emergence of resistant organisms.",2020,"We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
","['kidney transplant recipients with ASB', 'kidney transplant recipients who are more than two months post-transplantation', 'kidney transplant recipients who had ASB and were ≥2\xa0months post-transplantation', 'kidney transplant recipients with asymptomatic bacteriuria (BiRT', '199 kidney transplant recipients with ASB']","['antibiotics or no therapy', 'Antibiotics versus no therapy', 'antibiotics']","['incidence of symptomatic UTI', 'episode of bacteriuria', 'occurrence of symptomatic UTI']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",199.0,0.123239,"We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Coussement', 'Affiliation': 'Division of Infectious Diseases, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: juliencoussement@gmail.com.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, Hôpital Rangueil, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, INSERM U10403, Toulouse, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Matignon', 'Affiliation': ""Centre d'Investigation Clinique Biothérapie, Hôpital H. Mondor-A. Chenevier, APHP (Assistance Publique-Hôpitaux de Paris), Créteil, France; Université Paris-Est, UMR_S955, UPEC, Créteil, France; INSERM U955, Equipe 21, Créteil, France; Nephrology and Transplantation Department, Hôpital H. Mondor-A. Chenevier, APHP (Assistance Publique-Hôpitaux de Paris), Créteil, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Weekers', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Liège, Liège, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Scemla', 'Affiliation': 'Department of Nephrology - Transplantation, Hôpital Necker Enfants Malades, APHP (Assistance Publique-Hôpitaux de Paris), Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'Institute for Transplantation, Urology and Nephrology (ITUN), Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Racapé', 'Affiliation': ""Research Centre 'Biostatistiques, Epidémiologie et Recherche Clinique', École de Santé Publique, Université Libre de Bruxelles, Brussels, Belgium.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Alamartine', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mesnard', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Hôpital Tenon, APHP (Assistance Publique-Hôpitaux de Paris), Sorbonne Université, Paris, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Kianda', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ghisdal', 'Affiliation': 'Department of Nephrology, Centre Hospitalier EpiCURA, Baudour, Belgium.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Catalano', 'Affiliation': 'Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Emine N', 'Initials': 'EN', 'LastName': 'Broeders', 'Affiliation': 'Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Denis', 'Affiliation': 'Laboratory of Microbiology, CHU UCL Namur, Université Catholique de Louvain, Yvoir, Belgium.'}, {'ForeName': 'Karl M', 'Initials': 'KM', 'LastName': 'Wissing', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Nephrology Department, University Hospital of Lille, INSERM U995, Lille, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Abramowicz', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Antwerpen, Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.005']
1924,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
1925,32920973,Dietary Rapeseed Oil Supplementation Reduces Hepatic Steatosis in Obese Men-A Randomized Controlled Trial.,"SCOPE


Effective treatment for obesity associated non-alcoholic fatty liver disease (NAFLD) is limited. Dietary supplementation of n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA), can resolve intrahepatic lipid content (IHL). This study investigates the effect of daily supplementation of either refined rapeseed (RA), containing high amounts of ALA, or refined olive (OL) oil on IHL and glucose metabolism in NAFLD patients.
METHODS AND RESULTS


27 obese men consumed an isocaloric diet including either 50 g of RA or OL daily for 8 weeks. Hepatic proton magnetic resonance spectroscopy, hyperinsulinemic-euglycemic clamp studies and blood tests are performed before and at the end of the study. At 8 weeks a significant reduction in IHL is observed for RA (13.1 ± 1.6 before versus 11.1 ± 1.6% after intervention) versus OL (13.3 ± 2.5 before versus 15.7 ± 2.7% after intervention). For RA, a 21% reduction (P < 0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) is observed after 8 weeks.
CONCLUSION


RA has a beneficial effect on hepatic lipid metabolism as shown by reduced IHL and serum FFA. RA induced IL-6 production seems to be liver protective confirming previous results.",2020,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","['27 obese men consumed an', 'Obese Men', 'NAFLD patients']","['isocaloric diet including either 50\xa0g of RA or OL', 'n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA', 'refined rapeseed (RA), which contains high amounts of ALA, or refined olive (OL) oil', 'Dietary Rapeseed Oil Supplementation', 'OL']","['BMI', 'serum interleukin-6 (IL-6', 'Hepatic Steatosis', 'serum free fatty acids (FFA', 'IHL and serum FFA', 'hepatic lipid metabolism', 'IHL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",27.0,0.0850338,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Kemper', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osterhoff', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dannenberger', 'Affiliation': 'Leibniz Institute for Farm Animal Biology, Institute of Muscle Biology and Growth, 18196, Dummerstorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Markgraf', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hierholzer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Ernst von Bergmann Hospital, 14467, Potsdam, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), München, 85764, Neuherberg, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Department of Clinical Nutrition, 14558, Nuthetal, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000419']
1926,32917847,Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial.,"BACKGROUND


International guidelines for resuscitation recommend using positive end-expiratory pressure (PEEP) during ventilation of preterm newborns. Reliable PEEP-valves for self-inflating bags have been lacking, and effects of PEEP during resuscitation of term newborns are insufficiently studied. The objective was to determine if adding a new PEEP valve to the bag-mask during resuscitation of term and near-term newborns could improve heart rate response.
METHODS


This randomized controlled trial was performed at Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018). Helping Babies Breathe-trained midwives performed newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve. All live-born newborns who received bag-mask ventilation at birth were eligible. Heart rate response measured by ECG was the primary outcome, and clinical outcome and ventilation data were recorded.
RESULTS


Among 417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP. We found no difference in heart rate response. Median (interquartile range) measured PEEP in the PEEP group was 4.7 (2.0-5.6) millibar. The PEEP group received lower tidal volumes (4.9 [1.9-8.2] vs 6.3 [3.9-10.5] mL/kg;  P  = .02) and had borderline lower expired CO 2  (2.9 [1.5-4.3] vs 3.3 [1.9-5.0] %;  P  = .05). Twenty four-hour mortality was 9% in both groups.
CONCLUSIONS


We found no evidence for improved heart rate response during bag-mask ventilation with PEEP compared with no PEEP. The PEEP valve delivered a median PEEP within the intended range. The findings do not support routine use of PEEP during resuscitation of newborns around term.",2020,"Twenty four-hour mortality was 9% in both groups.
","['Newborn Resuscitation', '417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP', 'Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018', 'preterm newborns']","['PEEP', 'bag-mask ventilation', 'newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve']","['clinical outcome and ventilation data', 'Heart rate response', 'heart rate response', 'lower tidal volumes']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0337738', 'cui_str': 'Lutheran Church'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.307533,"Twenty four-hour mortality was 9% in both groups.
","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Holte', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway; kari.holte@so-hf.no.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ersdal', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Eilevstjønn', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Gomo', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Klingenberg', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Thallinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Vestre Viken Hospital Trust, Bærum, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Linde', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Stigum', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Yeconia', 'Affiliation': 'Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania; and.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Kidanto', 'Affiliation': 'Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Størdal', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway.'}]",Pediatrics,['10.1542/peds.2020-0494']
1927,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
1928,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
1929,32920186,"An invited commentary on: ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection"" (International Journal of Surgery 2020).",,2020,,[],['Gentamicin-Saline Solution versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.304305,,"[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey. Electronic address: howls_Castle@mynet.com.'}, {'ForeName': 'Huriye', 'Initials': 'H', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.009']
1930,32920219,COVID-19 associated kidney impairment in adult: Qualitative and quantitative analyses with non-enhanced CT on admission.,"PURPOSE


To qualitatively and quantitatively assess kidney imapairment in adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT) and possible correlation between renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission.
METHODS


This study was approved by the local institutional ethics committee. A total of 82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled. RPA and perinephric fat stranding (PFS) were evaluated on NECT imaging. According to the presence of PFS, the patients were divided into two groups: Group A, 38 patients with PFS, and Group B, 44 patients without PFS. Clinical data, including age, gender, clinical classification, SCr levels, and RPA on NECT were analysed. The RPA and SCr of the two groups with COVID-19 were analysed to determine possible difference and correlation. Eighty subjects with no kidney diseases were randomly selected as control group to determine the RPA of normal kidney performed on the same CT scanner.
RESULTS


Mean age, male to female ratio, number of severe and critical cases, and SCr of Group A were higher than those of Group B. Both mean RPA of Group A and Group B were lower than that of control. Mean RPA of Group A was even lower than that of Group B. A significant weak negative linear correlation between RPA on NECT and SCr in COVID-19 was indicated.
CONCLUSIONS


Decrease in RPA on NECT was observed in patients with COVID-19 and a weak linear negative correlation with SCr levels was found. The presence of PFS suggested more severe renal impairment in COVID-19. RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.",2020,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"['82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled', '38 patients with PFS, and Group B, 44 patients without PFS', 'adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT', 'Eighty subjects with no kidney diseases']",[],"['Mean RPA', 'renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission', 'severe renal impairment', 'RPA on NECT', 'SCr levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0227617', 'cui_str': 'Structure of fatty capsule of kidney'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",82.0,0.0205873,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Electrocadiogram, Affiliated Hangzhou First People's Hospital, College of Medicine, Zhejiang University, 261 Huansha Road, 310006, Hangzhou, Zhejiang, People's Republic of China; Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Shuangzhi', 'Initials': 'S', 'LastName': 'Lyu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Senxiang', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': ""Department of Radiation Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Liangrong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: 1191066@zju.edu.cn.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: chenfenghz@zju.edu.cn.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109240']
1931,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
1932,32920941,Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial.,"AIM


Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
METHOD


FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Patients with predicted clean-contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and noncoated suture and (4) 10% aqueous povidone-iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI.
CONCLUSION


FALCON will deliver high-quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.",2020,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","['5,480 patients', 'Patients with predicted clean-contaminated or contaminated/ dirty wounds with abdominal skin incision ≥5cm', 'patients in LMICs undergoing abdominal surgery', 'low- and middle-income countries']","['alcoholic chlorhexidine', 'alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, and (4) 10% aqueous povidone-iodine and triclosan-coated suture', 'povidone-iodine for skin preparation, and (2) triclosan-coated suture versus non-coated suture for fascial closure']","['SSI rates', 'SSI at 30-days, based on the Centers for Disease Control definition of SSI', 'surgical site infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0574780', 'cui_str': 'Wound dirty'}, {'cui': 'C0222166', 'cui_str': 'Skin structure of abdomen'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",5480.0,0.323638,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'NIHR Global Health Research Unit on Global Surgery, Universities of Birmingham, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhangu', 'Affiliation': 'NIHR Global Health Research Unit on Global Surgery, Universities of Birmingham, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15354']
1933,32929822,Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis.,"People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.",2020,Intervention patients also experienced improved quality of life.,"['people with decompensated cirrhosis', 'patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n =\u200957) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n =\u200959', 'People with chronic disease']",['patient-oriented education and medication management intervention'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.102154,Intervention patients also experienced improved quality of life.,"[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Hayward', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Valery', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Preya J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leigh U', 'Initials': 'LU', 'LastName': 'Horsfall', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Wright', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Tallis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Stuart', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Irvine', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Cottrell', 'Affiliation': 'Macrophage Biology Research Group, Mater Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Powell', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}]",Internal medicine journal,['10.1111/imj.14986']
1934,32931029,Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.,"BACKGROUND


The goal of this study was to assess the impact of trastuzumab on locoregional failure.
METHODS


The analysis included 2763 patients with HER2-positive (HER2+) breast cancer who were randomly assigned to adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n = 922]; arm B, AC→T→H [n = 988]; arm C, AC→T+H→H [n = 853]). Radiotherapy was given after AC→T concurrently with H. Radiotherapy was given after lumpectomy (L) or after mastectomy (M) with ≥4 positive lymph nodes but was optional for 1 to 3 positive lymph nodes. Locoregional failures at 10 years (LFR10) as first events were compared using competing risk analysis.
RESULTS


The median follow-up was 13.0 years. The first site of failure was local-only in 96 cases, locoregional in 16 cases, regional in 32 cases, and not specified in 2 cases; LFR10 was 4.8% (95% CI 4.1%-5.7%). LFR10 was 5.5% (95% CI 4.3%-7.2%), 4.9% (95% CI 3.7%-6.4%), and 2.8% (95% CI 1.9%-4.1%) in arms A, B, and C (B vs A: hazard ratio [HR] 0.91, P = .62; C vs A: HR 0.72, P = .12). For estrogen receptor-positive patients, LFR10 was 3.7% (95% CI 2.8%-4.8%) and for estrogen receptor-negative patients, it was 6.1% (95% CI 5.0%-7.4%; HR 0.61, P = .004). Local treatment included L+RT (n = 1044 [38%]), M+RT (n = 1025 [37%]), and M (n = 694 [25%]). LFR10 was 6.% (95% CI 5.0%-7.8%), 3.0% (95% CI 2.1%-4.3%), and 5.5% (95% CI 4.0%-7.4%) for L+RT, M+RT, and M, respectively (M+RT vs L+RT: HR 0.43, P < .001; M vs L+RT: HR 0.88, P = .57). For 1 to 3 positive lymph nodes, LFR10 was 6.5% (95% CI 4.8%-8.9%), 4.1% (95% CI 2.4%-7.0%), and 4.3% (95% CI 2.9%-6.5%) in L+RT, M+RT, and M, respectively (M vs L+RT: HR 0.68, P = .14; M vs M+RT: HR 1.2, P = .6).
CONCLUSION


Low 10-year LFRs were seen regardless of trastuzumab use. Differences in local therapy in patients with 1 to 3 positive lymph nodes did not appear to improve local control. Local therapy studies for HER2+ and other tumor characteristics are important as the role of local therapies continues to evolve.",2020,"(M vs L+RT: HR 0.68, P = .14;","['2763 patients with HER2-positive (HER2+) breast cancer', 'patients with 1 to 3 positive lymph nodes']","['L+RT', 'adjuvant trastuzumab', 'trastuzumab', 'adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n\xa0=\xa0922]; arm B, AC→T→H [n\xa0=\xa0988]; arm C, AC→T+H→H', 'M+RT', 'Radiotherapy']","['LFR10', 'Locoregional failures', 'locoregional failure rates', 'local control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2763.0,0.165357,"(M vs L+RT: HR 0.68, P = .14;","[{'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Thorpe', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Tenner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Davidson', 'Affiliation': 'Division of Medical Oncology, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'The Angeles Clinic and Research Institute, Santa Monica, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Shelley', 'Initials': 'ES', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michele Y', 'Initials': 'MY', 'LastName': 'Halyard', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Pockaj', 'Affiliation': 'Department of Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Department of Hematology & Oncology, Mayo Clinic, Jacksonville, Florida.'}]",Cancer,['10.1002/cncr.33154']
1935,32926462,Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials.,"BACKGROUND


Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1/JAK2, is in late-stage development for adult patients with moderate-to-severe AD.
OBJECTIVE


To report pooled safety data for baricitinib in patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies.
METHODS


This analysis included patient-level safety data from six double-blinded, randomized, placebo-controlled studies (one phase 2 and five phase 3), one double-blinded, randomized, LTE study and one open-label LTE study, reported in three data sets: placebo-controlled, 2-mg - 4-mg extended and All-bari AD. Safety outcomes include treatment-emergent adverse events, adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.
RESULTS


Data were collected for 2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days). The frequency of serious infections, opportunistic infections and conjunctival disorders was low and similar between treatment groups in the placebo-controlled period. The most common serious infections were eczema herpeticum [n = 11, incidence rates (IR) = 0.5], cellulitis (n = 6, IR = 0.3) and pneumonia (n = 3, IR = 0.1). There were four opportunistic infections (IR = 0.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients. Frequency of herpes simplex was higher in the 4-mg group (6.1%) vs. the 2-mg (3.6%) and placebo group (2.7%); IRs in the extended data set (2-mg IR = 9.6; 4-mg IR = 14.5) were lower vs. the placebo-controlled data set (2-mg IR = 12.4; 4-mg IR = 21.3). In the All-bari AD data set, there were two positively adjudicated major adverse cardiovascular events (2-mg group): two venous thrombosis events (4-mg group) and one death.
CONCLUSION


This integrated safety analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib.",2020,"No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients.","['adult patients with moderate-to-severe AD', 'patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies', 'adult patients with atopic dermatitis', '2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days', 'patients with moderate-to-severe AD']","['JAK1/JAK2', 'baricitinib', 'placebo', 'placebo-controlled, 2-mg - 4-mg extended, and All-bari AD']","['frequency of serious infections, opportunistic infections, and conjunctival disorders', 'venous thrombosis events', 'treatment-emergent adverse events, adverse events of special interest, and abnormal laboratory changes', 'Frequency of herpes simplex', 'No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis', 'adverse cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033333', 'cui_str': 'Program development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0009759', 'cui_str': 'Disorder of conjunctiva'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0151664', 'cui_str': 'Gastrointestinal perforation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]",2531.0,0.212392,"No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'University Med Cen Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Torrelo', 'Affiliation': 'Department of Dermatology, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Bruin-Weller', 'Affiliation': 'UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaci', 'Affiliation': 'Comprehensive Center for Inflammation Medicine, University Hospital Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Medical Dermatology Specialists, Atlanta, GA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nunes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brinker', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holzwarth', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Riedl', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16948']
1936,32931400,"Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial.","PURPOSE


Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children.
METHODS


This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period.
RESULTS


A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78%  v  59%;  P  = .001), delayed period (74%  v  47%;  P  < .001) and overall period (64%  v  38%;  P  < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001). Grade 1/2 somnolence was greater in the olanzapine group (35%  v  11%;  P  < .001). There was no grade 3/4 somnolence reported.
CONCLUSION


Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.",2020,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","['children (ages 5-18 years', 'children receiving the first cycle of HEC', 'adult patients', '240 patients underwent randomization', 'Children and Adolescents Receiving Highly Emetogenic Chemotherapy', '231 patients (116 in the control group and 115 in the study group']","['olanzapine', 'chemotherapy block and 3 days postchemotherapy', 'Olanzapine', 'aprepitant, ondansetron, and dexamethasone', 'oral olanzapine', 'emetogenic chemotherapy (HEC']","['complete response (CR) rates (no vomiting and no rescue medication', 'Vomiting', 'nausea and vomiting (CINV', 'proportion of patients with no nausea', 'Nausea comparison and safety evaluation', 'CR rates for vomiting', 'Grade 1/2 somnolence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",240.0,0.111181,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","[{'ForeName': 'Ramavath D', 'Initials': 'RD', 'LastName': 'Naik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwati S', 'Initials': 'AS', 'LastName': 'Pillai', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00871']
1937,32931978,"Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.","BACKGROUND


Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.
MATERIALS AND METHODS


A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm 2  were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.
RESULTS


In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.
CONCLUSION


Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.",2020,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","['patients with a Ventral Hernia Working Group Grade 3 hernia', 'Patients aged ≥ 18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included', '84 patients were treated with Phasix™ Mesh', 'patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair', 'These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula', 'potentially contaminated incisional hernias', '15 hospitals across Europe']","['new slowly resorbable biosynthetic mesh (Phasix™', 'Phasix™ Mesh', 'new resorbable biosynthetic mesh (Phasix™']","['hernia recurrences', 'rate of resorption', 'acceptable postoperative surgical site occurrence rates', 'rate of surgical site occurrences (SSO), including infections, that required intervention until 3 months after repair', 'recurrence rate', 'quality of life', 'surgical site occurrence development', '32 surgical site occurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",84.0,0.180861,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","[{'ForeName': 'Mathilde Mj', 'Initials': 'MM', 'LastName': 'van Rooijen', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. Electronic address: m.vanrooijen@erasmusmc.nl.'}, {'ForeName': 'An P', 'Initials': 'AP', 'LastName': 'Jairam', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Imelda Hospital, Department of General Surgery, Bonheiden, Belgium.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'University of Copenhagen, Bispebjerg Hospital, Department of Surgery, Copenhagen, Denmark.'}, {'ForeName': 'Tammo S', 'Initials': 'TS', 'LastName': 'de Vries Reilingh', 'Affiliation': 'Elkerliek Hospital, Department of Surgery, Helmond, The Netherlands.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'University Hospital Lille, Department of Surgery, Lille, France.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Vivantes Klinikum Spandau, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium.'}, {'ForeName': 'Alastair Cj', 'Initials': 'AC', 'LastName': 'Windsor', 'Affiliation': 'University College London Hospital, Department of Colorectal Surgery, London, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'University Hospital Ghent, Department of General and Hepatobiliary Surgery, Ghent, Belgium.'}, {'ForeName': 'René H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Wilhelminenhospital, Department of General, Visceral and Oncologic Surgery, Vienna, Austria.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Hôpital Cochin, Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris, France.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Woeste', 'Affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt Am Main, Germany.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Isala Zwolle, Department of Surgery, Zwolle, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gossetti', 'Affiliation': 'Università di Roma Sapienza, Rome, Italy.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands; IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Geert Wm', 'Initials': 'GW', 'LastName': 'Tetteroo', 'Affiliation': 'IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Chirurgische Praxis Cottbus, Cottbus Area, Germany.'}, {'ForeName': 'Leonard F', 'Initials': 'LF', 'LastName': 'Kroese', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.053']
1938,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
1939,32919170,Is Moulage effective in improving clinical skills of nursing students for the assessment of pressure injury?,"BACKGROUND


In wound care simulations, the practice can be performed on 3D-wounds formed by moulage. Moulage helps the student to perceive the etiology, physiology, and healing processes of the wound, and it can also be used to improve the students' wound assessment skills.
OBJECTIVE


The aim of this study is to investigate the effectiveness of moulage in the improvement of pressure injury assessment skills of nursing students.
DESIGN


A quasi-experimental study.
SETTINGS


A nursing faculty at a public university.
PARTICIPANTS


All fourth-year students (n = 73) who take the simulation elective course were invited to participate.
METHODS


Fall semester students (n = 38) constituted the control group and spring semester students (n = 35) formed the intervention group. The coin-flipping method was used to match the education period and student groups. The intervention group simulation was performed using moulage, and the control group simulation was performed using a pressure ulcer visuals. The same simulation scenarios were used for both groups. The data were collected using the Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers.
RESULTS


Students' knowledge scores for pressure injury assessment have improved significantly in both the intervention group (pre-test:61.71 ± 9.77 and post-test 70.57 ± 12.53, t = -4.27, p < 0.001) and the control group (pre-test: 66.81 ± 13.47 and post-test 73.06 ± 15.50, t = -2.34, p = 0.02). Laboratory and clinical pressure injury assessment skill scores of the intervention group students were significantly higher than the control group. Besides, the correct staging percentages of the intervention group students are higher than the control group students during the clinical practice (χ2 = 5.05, p = 0.02).
CONCLUSIONS


It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.",2020,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"['All fourth-year students (n\xa0=\xa073) who take the simulation elective course were invited to participate', 'Fall semester students (n\xa0=\xa038) constituted the control group and spring semester students (n\xa0=\xa035) formed the intervention group', 'nursing students']",[],"['Laboratory and clinical pressure injury assessment skill scores', 'knowledge scores for pressure injury assessment', 'Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",73.0,0.0183299,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Sezgunsay', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Stoma and Wound Care Centre, Ankara, Turkey.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Ankara, Turkey. Electronic address: tulay.basak@sbu.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2020.104572']
1940,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
1941,32920498,Ocrelizumab Treatment in Patients with Primary Progressive Multiple Sclerosis: Short-term Safety Results from a Compassionate Use Programme in Germany.,"OBJECTIVES


In January 2018, the European Union (EU) approved ocrelizumab in relapsing multiple sclerosis (RMS) and as the first disease-modifying therapy (DMT) for patients with primary progressive multiple sclerosis (PPMS) with efficacy proven in a phase 3 randomised controlled trial. Eleven months prior to the European regulatory approval, a compassionate use programme (CUP) made ocrelizumab available to 489 patients with PPMS in Germany, thereby for the first time providing a therapeutic option to patients with PPMS who could not participate in ocrelizumab studies. Here, we report real-world patient characteristics and short-term safety data of patients with PPMS treated with ocrelizumab in this CUP.
PATIENTS AND METHODS


This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU. Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres. The main exclusion criteria were current/recent treatment with other immune therapies and unresolved/chronic/active infections. Patients received methylprednisolone and an antihistamine before treatment with intravenous ocrelizumab in 6-month cycles. The first ocrelizumab dose was a 300 mg infusion followed by a second 300 mg infusion 2 weeks later; subsequent doses were delivered as a single 600 mg infusion. Adverse events were reported immediately.
RESULTS


Of 580 requests received from 104 centres, 525 patients met the eligibility criteria. Thirty-five patients did not participate due to withdrawal by the treating physician, and one due to death prior to treatment. A total of 489 patients received at least one 600 mg dose of ocrelizumab (administered as two 300 mg infusions) and 51 received a second dose. Due to termination of the CUP upon marketing authorisation, the maximum follow-up period was 12 months. Median patient age was 52 years (range: 24-73), and 49% were female. Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate. Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP. Nine serious adverse events and 70 non-serious adverse events were reported in 40 patients. Adverse event categories were generally consistent with the known safety profile of ocrelizumab; one patient had carry-over progressive multifocal leukoencephalopathy (PML) due to previous natalizumab treatment.
CONCLUSION


This CUP provides first real-world observations of ocrelizumab for the treatment of PPMS in a large patient cohort in Germany, supporting that ocrelizumab is generally well-tolerated in clinical practice. Physicians should be vigilant for early symptoms of PML, as to date, 9 PML cases that were all confounded have been reported in patients treated with ocrelizumab worldwide, with 8 carry-over cases from a prior DMT.",2020,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","['489 patients with PPMS in Germany', '489 patients', 'Patients with Primary Progressive Multiple Sclerosis', '525 patients met the eligibility criteria', 'patients with primary progressive multiple sclerosis (PPMS', 'Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres', 'patients with PPMS treated with ocrelizumab in this CUP', 'patients with PPMS who could not participate in ocrelizumab studies', 'Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP', 'Of 580 requests received from 104 centres', 'Median patient age was 52 years (range: 24-73), and 49% were female', 'This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU']","['ocrelizumab', 'methylprednisolone', 'intravenous ocrelizumab', 'glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate', 'antihistamine', 'Ocrelizumab']",['Adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C2718016', 'cui_str': 'Compassionate Use'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",489.0,0.02963,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rauer', 'Affiliation': 'Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany. Electronic address: sebastian.rauer@uniklinik-freiburg.de.'}, {'ForeName': 'Muna-Miriam', 'Initials': 'MM', 'LastName': 'Hoshi', 'Affiliation': 'Neurologische Klinik, Technische Universität München, Munich, Germany. Electronic address: muna.hoshi@ms-klinik.de.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Pul', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Essen, Germany. Electronic address: refik.pul@uk-essen.de.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wahl', 'Affiliation': 'Zentrum der Neurologie und Neurochirugie, Universitätsklinikum Frankfurt, Frankfurt, Germany. Electronic address: wahl@med.uni-frankfurt.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Jena, Jena, Germany. Electronic address: matthias.schwab@med.uni-jena.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Jüdisches Krankenhaus Berlin, Berlin, Germany. Electronic address: judith.haas@jkb-online.de.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Ellrichmann', 'Affiliation': 'Klinik für Neurologie, St. Josef-Hospital, Bochum, Germany. Electronic address: gisa.ellrichmann@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Krumbholz', 'Affiliation': 'Department of Neurology & Stroke and Hertie-Institute for Clinical Brain Research, Eberhard Karl University of Tübingen, Tübingen, Germany. Electronic address: markus.krumbholz@uni-tuebingen.de.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Zentrum für Neuroimmunologie, Universitätsklinikum Marburg, Marburg, Germany; F. Hoffmann-La Roche AG, Basel, Switzerland. Electronic address: tackenbb@staff.uni-marburg.de.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Saum', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: kai-uwe.saum@roche.com.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Buck', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: fabian.buck@roche.com.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Leemhuis', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: jost.leemhuis@roche.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kretschmann', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: anita.kretschmann@roche.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Klinik für Neurologie, Medizinische Fakultät, Universitätsklinikum Düsseldorf, Düsseldorf, Germany. Electronic address: orhan.aktas@med.uni-duesseldorf.de.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106142']
1942,32921196,Attainment of Targets of the 20-Year Infancy-Onset Dietary Intervention and Blood Pressure Across Childhood and Young Adulthood: The Special Turku Coronary Risk Factor Intervention Project (STRIP).,"We examined whether success in achieving the key targets of an infancy-onset 20-year dietary intervention was associated with blood pressure (BP) from infancy to young adulthood. In the prospective randomized STRIP (Special Turku Coronary Risk Factor Intervention Project; n=877 children), dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains. Dietary data and BP were accrued annually from the age of 13 months to 20 years. The dietary targets for fat quality were defined as the ratio of saturated fatty acids to monounsaturated and polyunsaturated fatty acids <1:2 and intake of saturated fatty acids <10 E%, dietary fiber intake in the top age-specific quintile, and dietary sucrose intake as being in the lowest age-specific quintile. Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3] mm Hg;  P =0.02). When the lowest age-specific quintile of dietary cholesterol was added as an additional target, the association with systolic BP remained significant ( P =0.047), but the association with diastolic BP attenuated ( P =0.13). Achieving the key targets of an infancy-onset 20-year dietary intervention, reflecting dietary guidelines, was favorably albeit modestly associated with systolic and diastolic BP from infancy to young adulthood. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00223600.",2020,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3",['Across Childhood and Young Adulthood'],"['20-Year Infancy-Onset Dietary Intervention and Blood Pressure', ""dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains""]","['systolic and diastolic BP', 'systolic BP', 'blood pressure (BP', 'Dietary data and BP', 'diastolic BP']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0585342', 'cui_str': 'Every other year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",877.0,0.0185772,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3","[{'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Nuotio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Centre for Population Health Research (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine (M.J., J.S.A.V., T.R.), University of Turku, Finland.'}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sabin', 'Affiliation': ""Murdoch Children's Research Institute (T.T.L., J.N., M.S., D.B.), The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burgner', 'Affiliation': ""Murdoch Children's Research Institute (T.T.L., J.N., M.S., D.B.), The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Department of Pediatric Cardiology, Hospital for Children and Adolescents, University of Helsinki, Finland (E.J.).'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Centre for Population Health Research (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, Institute for Health and Welfare, Turku, Finland (A.J.).'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine (H.N., O.S.), Turku University Hospital, University of Turku, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.), University of Turku, Finland.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15075']
1943,32923016,Efficacy and safety of triazavirin therapy for coronavirus disease 2019: A pilot randomized controlled trial.,"No therapeutics have been proven effective yet for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To assess the efficacy and safety of Triazavirin therapy for COVID-19, we conducted a randomized, double-blinded controlled trial involving hospitalized adult patients with COVID-19. Participants were enrolled from ten sites, and were randomized into two arms of the study with a ratio of 1:1. Patients were treated with Triazavirin 250 mg versus a placebo three or four times a day for 7 d. The primary outcome was set as the time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT) until 28 d after randomization. Secondary outcomes included individual components of the primary outcome, the mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling. Concomitant therapeutic treatments, adverse events, and serious adverse events were recorded. Our study was halted after the recruitment of 52 patients, since the number of new infections in the participating hospitals decreased greatly. We randomized 52 patients for treatment with Triazavirin ( n  = 26) or a placebo ( n  = 26). We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2). All components of the primary outcome normalized within 28 d, with the exception of absorption of pulmonary infection (Triazavirin 50.0%, placebo 26.1%). Patients in the Triazavirin group used less frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports. Although no statistically significant evidence was found to indicate that Triazavirin benefits COVID-19 patients, our observations indicated possible benefits from its use to treat COVID-19 due to its antiviral effects. Further study is required for confirmation.",2020,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","['Participants were enrolled from ten sites', 'hospitalized adult patients with COVID-19', 'coronavirus disease 2019']","['placebo', 'Triazavirin', 'Triazavirin therapy', 'triazavirin therapy']","['time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT', 'time to clinical improvement', 'mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling', 'frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports', 'efficacy and safety', 'absorption of pulmonary infection', 'adverse events, and serious adverse events', 'Efficacy and safety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",52.0,0.423282,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ', ,.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ', ,.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ', ,.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ', ,.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': ', ,.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ', ,.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ', ,.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ', ,.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ', ,.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ', ,.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ', ,.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ', ,.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ', ,.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.08.011']
1944,32924207,Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial.,"BACKGROUND AND AIMS


Reducing alcohol consumption by liver disease patients can reduce morbidity and mortality. This study compared a computer-delivered brief alcohol intervention (cBAI) with standard care in a sample of US military veterans with liver disease.
DESIGN


Multi-site, randomized controlled trial of a cBAI plus standard care (n = 67) versus standard care only (n = 71). Participants were assessed at baseline and 3- and 6-month follow-up.
SETTING


US Veterans Health Administration liver clinics.
PARTICIPANTS


Participants were mostly male and diagnosed with hepatitis C.
INTERVENTIONS AND COMPARATORS


A cBAI tailored to veterans with liver disease and consisting of assessment and personalized feedback. Standard care was brief education and advice about alcohol and liver disease.
MEASUREMENT


Primary outcomes were self-reported number of drinking days and unhealthy drinking days (defined as more than two drinks for men and more than one for women) in the past 30 days at 6-month follow-up. Secondary outcomes were these two variables at 3-month follow-up, and drinks consumed per drinking day, depression and overall health at 3- and 6-month follow-ups. Missing data were imputed using multiple imputation.
FINDINGS


Compared with standard care, cBAI participants reported significantly fewer drinking days at 6-month follow-up and fewer unhealthy drinking days at both 3- and 6-month follow-ups. Least square means (LS-means) for number of drinking days were 3.78 for the cBAI condition and 6.89 for the standard care condition at 6 months [LS-mean ratio = 3.78/6.89 = 0.55, 95% confidence interval (CI) = 0.34, 0.89]. LS-means for number of unhealthy drinking days were 1.04 for the cBAI condition and 2.57 for the standard care condition at 3-month follow-up (LS-mean ratio = 1.04/2.57 = 0.41, 95% CI = 0.19, 0.85). At 6-months follow-up, LS-means were 1.18 for the cBAI condition and 2.75 for the standard care condition (LS-mean ratio = 1.18/2.75 = 0.43, 95% CI = 0.20, 0.91).
CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.",2020,"CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","['Participants were mostly male and diagnosed with hepatitis C', 'liver disease patients', 'n=71', 'Patients with Liver Disease', 'military veterans with liver disease', 'US Veterans Health Administration liver clinics']","['Computer-Delivered Brief Alcohol Intervention', 'cBAI plus standard care (n=67) versus standard care only', 'computer-delivered brief alcohol intervention (cBAI) with standard care']","['morbidity and mortality', '3-month follow-up, and drinks consumed per drinking day, depression, and overall health', 'self-reported number of drinking days and unhealthy drinking days (defined as >2 drinks for men and >1 for women']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.062993,"CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cucciare', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'Combs', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Humphreys', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15263']
1945,32924240,Clinical Performance of Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures: Stage One Results of a Randomized Controlled Trial.,"PURPOSE


To prospectively compare the clinical performance of posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs).
MATERIALS AND METHODS


After simple randomization, 30 participants received either one inlay-retained (n = 15; mean age: 56.38 ± 12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean age: 45.90 ±13.24 years; 7 men [46.7%]) FPD. The restorations, which predominantly replaced first molars, were fabricated from translucent, 3 mol% yttria-stabilized zirconia and attached with self-etching resin cement. Restorations and abutment teeth were clinically followed up for complications one week and 3, 6, and 12 months after cementation. Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations. The restorations were also assessed in accordance with FDI World Dental Federation criteria. Statistical analyses were conducted with R (α = 0.05). An adaptive, 2-stage study design based on the incidence of failure-free survival in the groups after 12 months (stage 1) was implemented. Predefined decision rules were used to determine whether further recruitment (stage 2) would enable the detection of a statistically significant difference between the restoration designs with sufficient power.
RESULTS


During 12 months, only one wing retainer debonded which required removal of the FPD. Failure-free survival was thus 93.3% for wing-retained and 100% for inlay-retained FPDs (log-rank test, p = 0.317). Moderate aftercare resulted in intervention-free rates of 78.8% and 86.7% for inlay-retained and wing-retained restorations, respectively (log-rank test, p = 0.605). Based on FDI World Dental Federation criteria, all restorations were acceptable at the 12-month follow-up (Fisher-Boschloo test, p = 0.161). Plaque, gingival, and periodontal scores remained practically unchanged from before treatment to the 12-month follow-up. Recruitment was stopped after stage 1 because, based on the small difference in the incidence of failure-free survival in the groups, it was accepted that it would not be possible to recruit the necessary number of participants to show a statistically significant difference between the retainer designs.
CONCLUSIONS


Both inlay-retained and wing-retained monolithic zirconia resin-bonded FPDs performed well for the 12-month, short-term follow-up period.",2020,"Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations.",['30 participants received either one inlay-retained (n = 15; mean age: 56.38 ±12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean age: 45.90 ±13.24 years; 7 men [46.7%]) FPD'],"['Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures', 'posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs']","['Plaque and gingival scores, probing pocket depths, and attachment levels', 'Plaque, gingival, and periodontal scores', 'intervention-free rates', 'incidence of failure-free survival', 'Failure-free survival']","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517843', 'cui_str': '66.7'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0085071', 'cui_str': 'Maryland bridge'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.150442,"Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Rathmann', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Pilz', 'Affiliation': 'Department of Medical Biometry, Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Justo Lorenzo', 'Initials': 'JL', 'LastName': 'Bermejo', 'Affiliation': 'Department of Medical Biometry, Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Waldecker', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ohlmann', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zenthöfer', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13258']
1946,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
1947,32919517,"Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Cytomegalovirus is a common congenital infection, with high morbidity after an early primary maternal infection. No effective means exist to prevent viral transmission to the fetus. We aimed to investigate whether valaciclovir can prevent vertical transmission of cytomegalovirus to the fetus in pregnant women with a primary infection acquired early in pregnancy.
METHODS


This prospective, randomised, double-blind, placebo-controlled trial was done at the Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel). Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy, were randomly assigned to oral valaciclovir (8 g per day, twice daily) or placebo from enrolment until amniocentesis at 21 or 22 gestational weeks. Randomisation was done separately for participants infected periconceptionally or during the first trimester and was done in blocks of four. Patients and researchers were masked to participant allocation throughout the entire study period. The primary endpoint was the rate of vertical transmission of cytomegalovirus. Statistical analyses were done according to per-protocol principles. The study was registered at ClinicalTrials.gov, NCT02351102.
FINDINGS


Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive valaciclovir or placebo. Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group. In the valaciclovir group, including both first trimester and periconceptional infections, five (11%) of 45 amniocenteses were positive for cytomegalovirus, compared with 14 (30%) of 47 amniocenteses in the placebo group (p=0·027; odds ratio 0·29, 95% CI 0·09-0·90 for vertical cytomegalovirus transmission). Among participants with a primary cytomegalovirus infection during the first trimester, a positive amniocentesis for cytomegalovirus was significantly less likely in the valaciclovir group (two [11%] of 19 amniocenteses) compared with the placebo group (11 [48%] of 23 amniocenteses; p=0·020. No clinically significant adverse events were reported.
INTERPRETATION


Valaciclovir is effective in reducing the rate of fetal cytomegalovirus infection after maternal primary infection acquired early in pregnancy. Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
FUNDING


None.",2020,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","['pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus', 'pregnant women with a primary infection acquired early in pregnancy', 'Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group', 'Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy', 'cytomegalovirus after maternal primary infection during pregnancy', 'Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel', 'Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive']","['valaciclovir or placebo', 'Valaciclovir', 'valaciclovir', 'placebo', 'oral valaciclovir']","['rate of vertical transmission of cytomegalovirus', 'positive amniocentesis for cytomegalovirus', 'rate of fetal cytomegalovirus infection', 'adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0948192', 'cui_str': 'Primary infection NOS'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242648', 'cui_str': 'Vertical infection transmission'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.675587,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Shahar-Nissan', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: kerens411@gmail.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pardo', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Peled', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Krause', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Efraim', 'Initials': 'E', 'LastName': 'Bilavsky', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Wiznitzer', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Hadar', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Amir', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31868-7']
1948,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE


The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY


To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS


This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS


The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2020,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Márcia Viana', 'Initials': 'AMV', 'LastName': 'Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique Soares', 'Initials': 'GHS', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa Maria da Silva', 'Initials': 'EMDS', 'LastName': 'Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita de Cássia Matos', 'Initials': 'RCM', 'LastName': 'Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'Fabrício Mesquita', 'Initials': 'FM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
1949,32930610,Co-Occurring Psychopathology Moderates Social Skills Improvement in a Randomized Controlled Trial of a Collaborative School-Home Intervention for Children with ADHD.,"OBJECTIVE


Children with ADHD often exhibit marked impairment in their social skills, but evidence-based psychosocial interventions for ADHD have shown limited efficacy in remediating these deficits. Co-occurring psychopathology exacerbates social deficits in children with ADHD and is a plausible moderator of treatment response. To identify factors contributing to variable social skills treatment response, we examined co-occurring externalizing, depression, and anxiety symptoms as moderators of social skills outcomes in a randomized controlled trial of the Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention.
METHOD


Participants were 159 children with ADHD ( M  age = 8.35 years, 28.3% female) at 27 schools in an urban public school district. Twenty-three schools were randomly assigned to CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services. Multi-informant measures of co-occurring psychopathology and social skills were collected at baseline and post-treatment.
RESULTS


Parent-rated externalizing and depression symptoms moderated treatment effects on social skills, whereby higher symptomatology in each domain was unrelated to social skills improvement in the CLS group but predicted worsening social skills in response to usual services. In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
CONCLUSIONS


Findings reflect novel evidence that child psychopathology domains exhibit unique moderating effects on social skills treatment response in children with ADHD. We discuss implications for optimizing evidence-based interventions to target social impairment in this population.",2020,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","['children with ADHD', 'Children with ADHD', 'Twenty-three schools', 'Participants were 159 children with ADHD ( M  age\xa0=\xa08.35\xa0years, 28.3% female) at 27 schools in an urban public school district']","['Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention', 'CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services', 'Collaborative School-Home Intervention', 'Co-Occurring Psychopathology Moderates Social Skills']","['social skills', 'worsening social skills', 'Multi-informant measures of co-occurring psychopathology and social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0915905', 'cui_str': 'IS 159'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",159.0,0.0397701,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Jocelyn I', 'Initials': 'JI', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Pfiffner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1815206']
1950,32924674,How hearing conservation training format impacts personal attenuation ratings in U.S. Marine Corps Training Recruits.,"OBJECTIVE


The purpose of this fit-testing study in the field was to systematically compare three Hearing Protection Device (HPD) fit-training methods and determine whether they differ in the acquisition of HPD fitting skill and resulting amount of earplug attenuation.
DESIGN


Subjects were randomly assigned to receive HPD fit-training using one of three training methods:  current ,  experiential HPD  (eHPD), and  integrated . Personal Attenuation Ratings (PARs) were acquired via HPD fit-testing and used to verify attenuations pre- and post-training.
STUDY SAMPLE


US Marine training recruits ( n  = 341) identified via HPD fit-testing for remedial HPD fit-training and assigned to three cohorts.
RESULTS


The post-training HPD fit-test passing rate differed by training method, with pass rates ranging from 50% (current) to nearly 92% (eHPD). The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
CONCLUSION


The HPD fit-training methods that teach ""what right feels like"" (eHPD and integrated) provided a greater number of trainees with the skill to achieve noise attenuation values required for impulse noise exposures encountered during basic training. The attenuation achieved by those methods was significantly greater than the current training method.",2020,"The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
","['SAMPLE\n\n\nUS Marine training recruits ( n \u2009=\u2009341) identified via HPD fit-testing for remedial HPD fit-training and assigned to three cohorts', 'Subjects']","['HPD fit-training using one of three training methods:  current ,  experiential HPD  (eHPD), and  integrated ']","['delta PAR values', 'Personal Attenuation Ratings (PARs']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0223195,"The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Federman', 'Affiliation': 'Naval Submarine Medical Research Laboratory, Groton, CT, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Karch', 'Affiliation': 'Naval Submarine Medical Research Laboratory, Groton, CT, USA.'}, {'ForeName': 'Christon', 'Initials': 'C', 'LastName': 'Duhon', 'Affiliation': 'Naval Hospital Beaufort, BHC, MCRD, Parris Island, SC, USA.'}]",International journal of audiology,['10.1080/14992027.2020.1811407']
1951,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
1952,32936790,Efficacy and Safety of Neuromuscular Blockade in Overweight Patients Undergoing Nasopharyngeal Surgery.,"BACKGROUND Adequate muscle relaxation and rapid recovery of neuromuscular function are essential in the perioperative period. We therefore compared various anesthetic regimens of neuromuscular blockers and antagonists administered to overweight patients undergoing nasopharyngeal surgery. MATERIAL AND METHODS This prospective, randomized, double-blind study was conducted in overweight patients undergoing nasopharyngeal surgery. We randomly assigned 102 patients into 3 groups (each n=34) treated with various muscle relaxant agents and antagonists: rocuronium and sugammadex (Group RS), rocuronium and neostigmine (Group RN), and cisatracurium and neostigmine (Group CN). Then, we compared the efficacy and safety indexes of the 3 groups. RESULTS Onset times of muscular relaxation in Group RS and Group RN (110 s and 120 s) were shorter than in Group CN (183 s). Time from administration of antagonist to recovery of the TOF ratio to 0.9 was shorter in Group RS (3.3 min) than in other groups (20.7 min and 19.1 min, respectively). The incidence of postoperative residual curarization (PORC) was significantly lower in Group RS (5.9%) than in the other 2 groups (both 41.2%). The hemodynamic parameter changes before extubation were significantly higher in Group RN and Group CN than in Group RS. The postoperative pain scores were lowest in Group RS. CONCLUSIONS For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation. The combination of rocuronium and sugammadex may be the best anesthetic regimen for overweight patients undergoing nasopharyngeal surgery.",2020,"For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation.","['Overweight Patients Undergoing Nasopharyngeal Surgery', '102 patients into 3 groups (each n=34) treated with', 'overweight patients undergoing nasopharyngeal surgery']","['rocuronium with sugammadex', 'rocuronium and sugammadex', 'various muscle relaxant agents and antagonists: rocuronium and sugammadex (Group RS), rocuronium and neostigmine (Group RN), and cisatracurium and neostigmine (Group CN', 'Neuromuscular Blockade', 'neuromuscular blockers and antagonists']","['Efficacy and Safety', 'incidence of postoperative residual curarization (PORC', 'hemodynamic parameter changes before extubation', 'TOF ratio', 'efficacy and safety indexes', 'postoperative pain scores', 'occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948545', 'cui_str': 'Nasopharyngeal surgery'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4042763', 'cui_str': 'Postoperative Residual Curarisation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",102.0,0.0821534,"For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation.","[{'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Shanglong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926452']
1953,32938723,LION-PAW (lymphadenectomy in ovarian neoplasm) sexual function assessment: a prospective sub-study of the LION trial.,"BACKGROUND


There is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer.
OBJECTIVE


To evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial.
METHODS


The Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function.
RESULTS


Overall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4-75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this. The orgasm sub-scale showed diverging results with a deterioration from baseline to 12 months in the lymphadenectomy group compared with the no-lymphadenectomy group (p=0.02).
CONCLUSION


The majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.",2020,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","['patients with advanced ovarian cancer', ""55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available"", 'Median age was 60.5 years (range 21.4-75.8', '495 patients received the questionnaires', 'sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years']","['radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy', 'LION-PAW (lymphadenectomy']","['sexual function', 'sexual function according to its sub-scales activity, pleasure, and discomfort', 'Discomfort evaluated as dryness of the vagina and pain during sexual intercourse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0023756', 'cui_str': 'Panthera leo'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.0418331,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center, Mainz, Germany Annette.Hasenburg@unimedizin-mainz.de.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, New Hampshire, USA.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Lampe', 'Affiliation': 'Department of Gynecology and Obstetrics, Kaiserswerther Diakonie, Duesseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': 'Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ludwig-Maximilians-University Munich, München, Bayern, Germany.'}, {'ForeName': 'Antje Kristina', 'Initials': 'AK', 'LastName': 'Belau', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Bossart', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Department of Gynecology and Obstetrics, Medizinische Hochschule, Hannover, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Petry', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Wolfsburg, Wolfsburg, Niedersachsen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Herwig', 'Affiliation': 'Department of Gynecology and Obstetrics, Albertinen-Hospital Hamburg, Hamburg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gropp-Meier', 'Affiliation': 'Department of Gynecology and Obstetrics, St. Elisabethenhospital, Ravensburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hanf', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Fürth, Fürth, Bayern, Germany.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Clinical Psychology Unit, Medical University Graz, Graz, Steiermark, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Gießen and Marburg GmbH Site Marburg, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001551']
1954,32940955,Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII).
OBJECTIVE


Here, we report end-of-trial safety and efficacy results from the completed N8-GP pathfinder5 trial.
METHODS


pathfinder5 (NCT01731600) was a multi-national, open-label, single-arm, non-randomized, non-controlled trial in previously treated male patients aged <12 years old with severe hemophilia A that comprised a main and an extension phase. During the main phase, patients received twice-weekly N8-GP 60 IU/kg for 50 exposure days (~26 weeks). During the extension phase, patients received the same regimen until the end of trial (first patient in main phase, 20 February 2013; trial end, 28 September 2018).
RESULTS


Sixty-eight patients were exposed to N8-GP for a median time of ~4.9 years on regimen. Of the 63 patients who started in the extension phase, 62 completed the trial. No FVIII inhibitors (≥0.6 BU) or other safety concerns were detected. The overall estimated annualized bleeding rate was 1.08 (median 0.81), and nearly 20% of patients had no bleeds during the entire trial. The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure. All baseline target joints of patients who participated in both phases of this trial were resolved in slightly over 2 years.
CONCLUSION


Overall, data from the completed pathfinder5 trial show that long-term (median 4.9 years) N8-GP treatment was efficacious and well tolerated in previously treated pediatric patients with severe hemophilia A.",2020,"The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure.","['pediatric patients with severe hemophilia A', '63 patients who started in the extension phase, 62 completed the trial', 'male patients aged <12\xa0years old with severe hemophilia', 'Sixty-eight patients', 'previously treated pediatric patients with hemophilia A']",['N8-GP'],"['efficacious and well tolerated', 'annualized bleeding rate', 'spontaneous bleeds', 'proportion of patients with no annual bleeds']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",68.0,0.197585,"The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure.","[{'ForeName': 'Sonata', 'Initials': 'S', 'LastName': 'Šaulytė Trakymienė', 'Affiliation': ""Center for Pediatric Oncology and Hematology, Children's Hospital, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Economou', 'Affiliation': '1st Department of Pediatrics, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Chunduo', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kearney', 'Affiliation': ""Center for Bleeding and Clotting Disorders, Children's Hospital Minnesota, Minneapolis, MN, USA.""}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15036']
1955,32930621,"Effects of brief self-exercise education on the management of chronic low back pain: A community-based, randomized, parallel-group pragmatic trial.","OBJECTIVE


This study aimed to develop and assess additional effects of brief self-exercise education (brief-See) for individuals with chronic low back pain (CLBP). The brief-See comprised 100-minute consultation, individualized self-exercise program, and direct short teaching.
METHODS


We conducted a 6-month, community-based, randomized, parallel-group trial in a community setting, and allocated into a brief-See or material-based education alone. Pain intensity (NRS, numeric rating scale), functional limitation (RDQ, Roland-Morris disability questionnaire), self-efficacy (PSEQ, pain self-efficacy questionnaire), and quality of life (EQ-5D, European quality of life-5 dimensions) were evaluated at 4, 12, and 24 weeks after the initial consultation.
RESULTS


The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7,  p  = .005) on the RDQ, 6.9 (1.7-12.1,  p  = .010) on the PSEQ, and 0.07 (0.02-0.12,  p  = .004) on the EQ-5D.
CONCLUSION


The 100 minutes' education program could be more acceptable, and restores functional limitation, self-efficacy, and quality of life in addition to the effects of material-based education. This has the potential to contribute to the management of CLBP in a community.",2020,"The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P = 0.005) on the RDQ, 6.9 (1.7 to 12.1, P = 0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P = 0.004) on the EQ-5D. Conclusions:  ","['individuals with chronic low back pain (CLBP', 'chronic low back pain']","['brief-See or material-based education alone', 'brief self-exercise education (brief-See', 'brief self-exercise education']","['Pain intensity (NRS, numeric rating scale), functional limitation (RDQ, Roland-Morris disability questionnaire), self-efficacy (PSEQ, pain self-efficacy questionnaire), and quality of life (EQ-5D, European quality of life-5 dimensions', 'functional limitation, self-efficacy, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0582396', 'cui_str': 'Exercise education'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0437472,"The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P = 0.005) on the RDQ, 6.9 (1.7 to 12.1, P = 0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P = 0.004) on the EQ-5D. Conclusions:  ","[{'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Matsudaira', 'Affiliation': 'Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical & Research Center, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Kitamura', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Osaka, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Kakihana', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Oka', 'Affiliation': 'Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical & Research Center, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Hayama-Terada', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Yamagishi', 'Affiliation': 'Department of Public Health Medicine and Health Services Research and Development Center, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kiyama', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Department of Public Health Medicine and Health Services Research and Development Center, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Modern rheumatology,['10.1080/14397595.2020.1823603']
1956,32925345,Incidence of and Factors Associated With Prolonged and Persistent Postoperative Opioid Use in Children 0-18 Years of Age.,"BACKGROUND


Long-term opioid use has negative health care consequences. Opioid-naïve adults are at risk for prolonged and persistent opioid use after surgery. While these outcomes have been examined in some adolescent and teenage populations, little is known about the risk of prolonged and persistent postoperative opioid use after common surgeries compared to children who do not undergo surgery and factors associated with these issues among pediatric surgical patients of all ages.
METHODS


Using a national administrative claims database, we identified 175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery. Prolonged opioid use after surgery (filling ≥1 opioid prescription 90-180 days after surgery) was compared to a reference sample of 1,354,909 nonsurgical patients randomly assigned a false ""surgery"" date. Multivariable logistic regression models were used to estimate the association of surgical procedures and 22 other variables of interest with prolonged opioid use and persistent postoperative opioid use (filling ≥60 days' supply of opioids 90-365 days after surgery) for each age group.
RESULTS


Prolonged opioid use after surgery occurred in 0.77%, 0.76%, 1.00%, and 3.80% of surgical patients ages 0-<2, 2-<6, 6-<12, and 12-18, respectively. It was significantly more common in surgical patients than in nonsurgical patients (ages 0-<2: odds ratio [OR] = 4.6 [95% confidence interval (CI), 3.7-5.6]; ages 2-<6: OR = 2.5 [95% CI, 2.1-2.8]; ages 6-<12: OR = 2.1 [95% CI, 1.9-2.4]; and ages 12-18: OR = 1.8 [95% CI, 1.7-1.9]). In the multivariable models for ages 0-<12 years, few surgical procedures and none of the other variables of interest were associated with prolonged opioid use. In the models for ages 12-18 years, 10 surgical procedures and 5 other variables of interest were associated with prolonged opioid use. Persistent postoperative opioid use occurred in <0.1% of patients in all age groups.
CONCLUSIONS


Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare. Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain) may be at markedly higher risk.",2020,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","['Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain', 'pediatric surgical patients of all ages', '175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery', 'Children 0-18 Years of Age']",[],['Persistent postoperative opioid use'],"[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],"[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0613172,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'De Souza', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sun', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bambos', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'T Anthony', 'Initials': 'TA', 'LastName': 'Anderson', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004823']
1957,32925435,Patient satisfaction with intravenous regional anaesthesia or an axillary block for minor ambulatory hand surgery: A randomised controlled study.,"BACKGROUND


Intravenous regional anesthesia (IVRA) and the axillary brachial plexus block are popular alternatives to general anaesthesia in ambulatory hand surgery. Although both have proven their effectiveness, patients' preferences have never been evaluated.
OBJECTIVES


We investigated patient satisfaction with both techniques and hypothesised that satisfaction after IVRA is noninferior compared with axillary brachial plexus block.
DESIGN


A prospective, randomised controlled trial.
SETTING


Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from September 2016 to November 2017.
PATIENTS


One hundred and twenty adults undergoing minor ambulatory hand surgery were included in this study.
INTERVENTION


Patients received either IVRA with 300 mg lidocaine or an axillary block with 280 mg mepivacaine.
MAIN OUTCOME MEASURES


The primary endpoint was the evaluation of patient satisfaction using the 'Evaluation du Vécu de l'Anésthesie Locoregional' (EVAN-LR) questionnaire. Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20). Induction of anaesthesia and time to discharge, requiring partial recovery of the motor block, were significantly longer in the axillary brachial plexus block group. The IVRA-group had a lower block quality, a higher incidence of tourniquet-discomfort and higher median intra-operative and postoperative pain scores on day 0; 0 [0 to 2] vs. 0 [0 to 0] and 0.8 [0 to 1.8] vs. 0 [0 to 0.25], respectively, but no increase in the need for supplementary analgesics or conversion rate to general anaesthesia.
CONCLUSION


IVRA and axillary brachial plexus block result in comparably high patient satisfaction in ambulatory hand surgery.
CLINICAL TRIAL REGISTRATION


EudraCT 2016-002325-11.",2020,"Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20).","['Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from September 2016 to November 2017', 'One hundred and twenty adults undergoing minor ambulatory hand surgery were included in this study']","['intravenous regional anaesthesia or an axillary block for minor ambulatory hand surgery', 'IVRA with 300\u200amg lidocaine or an axillary block with 280\u200amg mepivacaine', 'Intravenous regional anesthesia (IVRA', 'EudraCT']","['median [IQR] total score on the EVAN-LR questionnaire', 'block quality', 'tourniquet-discomfort and higher median intra-operative and postoperative pain scores', 'Hodges--Lehmann estimator', ""evaluation of patient satisfaction using the 'Evaluation du Vécu de l'Anésthesie Locoregional' (EVAN-LR) questionnaire"", 'Induction of anaesthesia and time to discharge, requiring partial recovery of the motor block', 'procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0175952', 'cui_str': 'Day care center'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0401805', 'cui_str': 'Estimator'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",120.0,0.142823,"Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20).","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Teunkens', 'Affiliation': 'From the Department of Anesthesiology, University Hospitals Leuven, Herestraat (AT, KV, MV de V, SR), I-Biostat, KU Leuven- University of Leuven, Kapucijnenvoer (AB), Department of Orthopedics, University Hospitals Leuven, Herestraat (ID) and Department of Cardiovascular Sciences, KU Leuven - University of Leuven, Herestraat, Leuven, Belgium (AT, MV de V, SR).'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Vermeulen', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': ''}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Degreef', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Van de Velde', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001259']
1958,32926851,Various Surfaces Benefited Functional Outcomes and Fall Incidence in Individuals With Spinal Cord Injury: A Randomized Controlled Trial With Prospective Data Follow-up.,"OBJECTIVES


To compare effects of walking training on a walking track with different surfaces (WTDS), including artificial grass, soft, and pebbles, as compared to overground walking training on the functional ability necessary for independence and incidence of falls of ambulatory individuals with spinal cord injury (SCI).
DESIGN


A randomized controlled trial (single-blinded design) with 6-month prospective fall data follow-up.
SETTING


Tertiary rehabilitation centers and several communities.
PARTICIPANTS


Independent ambulatory individuals (N=54) with SCI who walked with or without a walking device.
INTERVENTION


Participants were randomly arranged into a control group (overground walking training, n=26) or experimental group (walking training over a WTDS, n=28) for 30 min/d, 5 d/wk over 4 weeks.
MAIN OUTCOME MEASURES


The 10-m walk test, timed Up and Go test, five times sit-to-stand test, and 6-minute walk test were repeatedly measured 4 times, including before training, and after 2 and 4 weeks, and 6 months. In addition, participants were prospectively monitored for the fall data over 6 months.
RESULTS


Participants who walked with an average speed of 0.52 m/s and postinjury time >7 years could safely walk over a WTDS. They demonstrated significant improvement at 2 and 4 weeks after experimental training (P<.001), but not after control training. During the 6-month follow-up, participants in the experimental group also had the number of those who fell (n=5, 18%) fewer than those in the control group (n=12, 46%).
CONCLUSIONS


Being at a chronic SCI with ability of independent walking, participants needed a challenging task to promote their functional outcomes and minimize fall risk. The findings suggest the use of various surfaces as an alternative rehabilitation strategy for these individuals.",2020,"They demonstrated significant improvement at 2-week and 4-week following experimental training (P<0.001), but not after control training.","['Tertiary rehabilitation centers and several communities', 'Independent ambulatory individuals with SCI who walked with or without a walking device (N = 54', 'ambulatory individuals with spinal cord injury (SCI', 'Participants who walked with an average speed of 0.52 m/s and post-injury time >7 years could safely walk over a WTDS', 'individuals with spinal cord injury']","['control group (overground walking training, N = 26) or experimental group (walking training over a WTDS', 'walking training', 'overground walking training']","['10-meter walk test, timed up and go test, five times sit-to-stand test, and 6-minute walk test']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]",54.0,0.0231193,"They demonstrated significant improvement at 2-week and 4-week following experimental training (P<0.001), but not after control training.","[{'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen. Electronic address: samata@kku.ac.th.'}, {'ForeName': 'Donlaya', 'Initials': 'D', 'LastName': 'Promkeaw', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen.'}, {'ForeName': 'Preeda', 'Initials': 'P', 'LastName': 'Arayawichanon', 'Affiliation': 'Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen; Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen; Department of Mechanical Engineering, Faculty of Engineering and Architecture, Rajamangala University of Technology Isan, Nakhon Ratchasima, Thailand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.009']
1959,32937046,Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease.,"BACKGROUND


Long-term oxygen therapy improves survival in patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia. However, the efficacy of oxygen therapy for the management of isolated nocturnal hypoxemia is uncertain.
METHODS


We designed this double-blind, placebo-controlled, randomized trial to determine, in patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years would decrease mortality or the worsening of disease such that patients meet current specifications for long-term oxygen therapy. Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry were assigned, in a 1:1 ratio, to receive either nocturnal oxygen or ambient air from a sham concentrator (placebo). The primary outcome was a composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population.
RESULTS


Recruitment was stopped prematurely because of recruitment and retention difficulties after 243 patients, of a projected 600, had undergone randomization at 28 centers. At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
CONCLUSIONS


Our underpowered trial provides no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with COPD. (Funded by the Canadian Institutes of Health Research; INOX ClinicalTrials.gov number, NCT01044628.).",2020,"At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
","['Chronic Obstructive Pulmonary Disease', 'patients with COPD', 'patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years', 'patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia', 'Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry']","['nocturnal oxygen or ambient air from a sham concentrator (placebo', 'Nocturnal Oxygen', 'placebo', 'Long-term oxygen therapy', 'oxygen therapy']","['nocturnal oxygen', 'survival', 'composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.675691,"At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lacasse', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Sériès', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Corbeil', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Baltzan', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Paradis', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Simão', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Abad Fernández', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Esteban', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Guimarães', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourbeau', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2013219']
1960,32937170,"Acute exercise increases circulating IGF-1 in Alzheimer's disease patients, but not in older adults without dementia.","OBJECTIVES


Increased Insulin-like growth factor I (IGF-1) has been associated with improvement of cognitive function in response to exercise. Evidences indicate a role for IGF-1 in beta-amyloid clearance and reducing hyperphosphorylation tau in Alzheimer's disease (AD). There is a need to investigate the IGF-1 response to exercise in AD patients due to well-known potential effects of exercise on IGF-1. The aim of this study was to examine circulating IGF-1 levels in AD patients and older adults without dementia after acute exercise and to verify the associations among cardiorespiratory fitness, cognition and IGF-1 levels.
METHOD


Seventy-four older adults (40 older adults without dementia and 34 AD patients) participated in this study. The outcomes included IGF-1 plasma levels and performance in the submaximal exercise stress test. Secondary outcomes included cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol. All participants performed the incremental test on a treadmill and IGF-1 was collected before and after the exercise.
RESULTS


A tendency to the difference of baseline IGF-1 plasma levels between the groups was found. After the acute exercise AD patients also presented higher levels of circulating IGF-1 compared to the Older adults without dementia. Correlations among cardiorespiratory fitness and cognitive functions were found.
CONCLUSION


The findings suggest that AD patients and older adults respond differently to acute exercise in terms of circulating IGF-1 levels. This response seems to indicate either an IGF-1 resistance or a compensatory exercise-induced to lower IGF-1 levels in AD patients. Cardiorespiratory fitness is associated with global cognition, executive function, attention and information processing speed.",2020,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[""Alzheimer's disease patients"", 'AD patients and older adults', ""Alzheimer's disease (AD"", 'Seventy-four older adults (40 older adults without dementia and 34 AD patients', 'AD patients and older adults without dementia after acute exercise']",['Acute exercise'],"['levels of circulating IGF-1', 'cardiorespiratory fitness and cognitive functions', 'IGF-1 levels', 'IGF-1 plasma levels and performance in the submaximal exercise stress test', 'baseline IGF-1 plasma levels', 'IGF-1 response', 'circulating IGF-1', 'cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol', 'circulating IGF-1 levels']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",74.0,0.0477822,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[{'ForeName': 'Angelica Miki', 'Initials': 'AM', 'LastName': 'Stein', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; UTFPR, Federal University of Technology - Paraná (UTFPR), Campus Curitiba, Brazil. Electronic address: angelica_stein@yahoo.com.br.'}, {'ForeName': 'Thays Martins Vital', 'Initials': 'TMV', 'LastName': 'da Silva', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Instituto Federal Goiano, Campus Avançado Hidrolândia, Brazil.'}, {'ForeName': 'Flávia Gomes de Melo', 'Initials': 'FGM', 'LastName': 'Coelho', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Postgraduate Program in Physical Education, Federal University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'André Veloso', 'Initials': 'AV', 'LastName': 'Rueda', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Camarini', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Ruth Ferreira Santos', 'Initials': 'RFS', 'LastName': 'Galduróz', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Center of Mathematics, Computing and Cognition, University Federal of ABC (UFABC), Campus São Bernardo, Brazil.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112903']
1961,32937232,A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.,"OBJECTIVE


This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.
DESIGN


Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken.
RESULTS


Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated.
CONCLUSIONS


Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.",2020,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.",[],"['fluoride-containing dentifrices', '1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse']","['tolerated', 'salivary fluoride ion concentrations', 'salivary calcium ion concentration']",[],"[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0288269,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: Gary.R.Burnett@gsk.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nehme', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: drmnehme@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parkinson', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: charles.x.parkinson@gsk.com.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Karwal', 'Affiliation': 'GSK Consumer Healthcare, One Horizon Center, Golf Course Road, DLF Phase 5, Gurgaon, 12202, India. Electronic address: ritukarwal0283@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Badrock', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: thomas.badrock@intertek.com.'}, {'ForeName': 'Gavin Vaughan', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: peter.hall@intertek.com.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104891']
1962,32938935,Time-restricted feeding alters lipid and amino acid metabolite rhythmicity without perturbing clock gene expression.,"Time-restricted feeding (TRF) improves metabolism independent of dietary macronutrient composition or energy restriction. To elucidate mechanisms underpinning the effects of short-term TRF, we investigated skeletal muscle and serum metabolic and transcriptomic profiles from 11 men with overweight/obesity after TRF (8 h day -1 ) and extended feeding (EXF, 15 h day -1 ) in a randomised cross-over design (trial registration: ACTRN12617000165381). Here we show that muscle core clock gene expression was similar after both interventions. TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites. In muscle, TRF induces rhythmicity of several amino acid transporter genes and metabolites. In serum, lipids are the largest class of periodic metabolites, while the majority of phase-shifted metabolites are amino acid related. In conclusion, short-term TRF in overweight men affects the rhythmicity of serum and muscle metabolites and regulates the rhythmicity of genes controlling amino acid transport, without perturbing core clock gene expression.",2020,"TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites.","['11 men with overweight/obesity after TRF (8\u2009h day -1 ) and extended feeding (EXF, 15\u2009h day -1 ']","['TRF', 'Time-restricted feeding (TRF']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}]",[],,0.0420832,"TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites.","[{'ForeName': 'Leonidas S', 'Initials': 'LS', 'LastName': 'Lundell', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'Ingerslev', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Altıntaş', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Center for Epigenetics and Metabolism, INSERM U1233, Department of Biological Chemistry, School of Medicine, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sassone-Corsi', 'Affiliation': 'Center for Epigenetics and Metabolism, INSERM U1233, Department of Biological Chemistry, School of Medicine, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Barrès', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juleen R', 'Initials': 'JR', 'LastName': 'Zierath', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Juleen.Zierath@ki.se.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia. john.hawley@acu.edu.au.'}]",Nature communications,['10.1038/s41467-020-18412-w']
1963,32939597,Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"RATIONALE


The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed.
OBJECTIVES


The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality.
METHODS


We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors.
RESULTS


In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p < 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p < 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37).
CONCLUSIONS


Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.",2020,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","['people with insomnia and healthy controls', 'elderly participants with insomnia complaints and age-matched healthy controls']","['zopiclone 7.5 mg and placebo', 'placebo-controlled pharmacological intervention']","['survival dynamics of sleep', 'SOL misperception', 'segment length of wake', 'average segment length of NREM sleep']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.024048,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05660-3']
1964,32905675,Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis.,"BACKGROUND


The efficacy and safety of combination therapy with eflornithine and sulindac, as compared with either drug alone, in delaying disease progression in patients with familial adenomatous polyposis are unknown.
METHODS


We evaluated the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis. The patients were stratified on the basis of anatomical site with the highest polyp burden and surgical status; the strata were precolectomy (shortest projected time to disease progression), rectal or ileal pouch polyposis after colectomy (longest projected time), and duodenal polyposis (intermediate projected time). The patients were then randomly assigned in a 1:1:1 ratio to receive 750 mg of eflornithine, 150 mg of sulindac, or both once daily for up to 48 months. The primary end point, assessed in a time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease.
RESULTS


A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine. Among 37 precolectomy patients, the corresponding values in the treatment groups were 2 of 12 patients (17%), 6 of 13 (46%), and 5 of 12 (42%) (hazard ratios, 0.30 [95% CI, 0.07 to 1.32] and 0.20 [95% CI, 0.03 to 1.32]); among 34 patients with rectal or ileal pouch polyposis, the values were 4 of 11 patients (36%), 2 of 11 (18%), and 5 of 12 (42%) (hazard ratios, 2.03 [95% CI, 0.43 to 9.62] and 0.84 [95% CI, 0.24 to 2.90]); and among 100 patients with duodenal polyposis, the values were 12 of 33 patients (36%), 14 of 34 (41%), and 13 of 33 (39%) (hazard ratios, 0.73 [95% CI, 0.34 to 1.52] and 0.76 [95% CI, 0.35 to 1.64]). Adverse and serious adverse events were similar across the treatment groups.
CONCLUSIONS


In this trial involving patients with familial adenomatous polyposis, the incidence of disease progression was not significantly lower with the combination of eflornithine and sulindac than with either drug alone. (Funded by Cancer Prevention Pharmaceuticals; ClinicalTrials.gov number, NCT01483144; EudraCT number, 2012-000427-41.).",2020,"Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine.","['37 precolectomy patients', 'Familial Adenomatous Polyposis', 'patients with familial adenomatous polyposis', 'adults with familial adenomatous polyposis', '171 patients underwent randomization']","['sulindac', 'eflornithine and sulindac', 'Eflornithine plus Sulindac', 'eflornithine-sulindac', 'eflornithine, 150 mg of sulindac']","['time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease', 'efficacy and safety', 'incidence of disease progression', 'Adverse and serious adverse events', 'Disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0038792', 'cui_str': 'Sulindac'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0013289', 'cui_str': 'Disorder of duodenum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",34.0,0.138184,"Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine.","[{'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lynch', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'N Jewel', 'Initials': 'NJ', 'LastName': 'Samadder', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Balaguer', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hüneburg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castells', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gallinger', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Stoffel', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Henderson', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Kallenberg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kanth', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Victorine H', 'Initials': 'VH', 'LastName': 'Roos', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Ginsberg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Strassburg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Church', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lalloo', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Wise', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Grady', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Ford', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Weiss', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gryfe', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Rustgi', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Syngal', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1916063']
1965,32905676,"Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide.","BACKGROUND


Darolutamide is a structurally distinct androgen-receptor inhibitor that is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. In the planned primary analysis of a phase 3 trial, the median metastasis-free survival was significantly longer with darolutamide (40.4 months) than with placebo (18.4 months). The data for the analysis of overall survival were immature at the time of the primary analysis.
METHODS


In this double-blind, placebo-controlled trial, we randomly assigned 1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or placebo (554 patients) while they continued to receive androgen-deprivation therapy. After the results of the primary end-point analysis were found to be positive, unblinding of the treatment assignments occurred, and patients in the placebo group were permitted to cross over to receive open-label darolutamide treatment. At the time of this prespecified final analysis, which had been planned to be performed after approximately 240 deaths had occurred, overall survival and all other secondary end points were evaluated.
RESULTS


The median follow-up time was 29.0 months. At the time of unblinding of the data, all 170 patients who were still receiving placebo crossed over to receive darolutamide; 137 patients who had discontinued placebo before unblinding had occurred received at least one other life-prolonging therapy. Overall survival at 3 years was 83% (95% confidence interval [CI], 80 to 86) in the darolutamide group and 77% (95% CI, 72 to 81) in the placebo group. The risk of death was significantly lower, by 31%, in the darolutamide group than in the placebo group (hazard ratio for death, 0.69; 95% CI, 0.53 to 0.88; P = 0.003). Darolutamide was also associated with a significant benefit with respect to all other secondary end points, including the time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy. The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
CONCLUSIONS


Among men with nonmetastatic, castration-resistant prostate cancer, the percentage of patients who were alive at 3 years was significantly higher among those who received darolutamide than among those who received placebo. The incidence of adverse events was similar in the two groups. (Funded by Bayer HealthCare and Orion Pharma; ARAMIS ClinicalTrials.gov number, NCT02200614.).",2020,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","['1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or', 'men with nonmetastatic, castration-resistant prostate cancer', '170 patients who were still receiving']","['androgen-deprivation therapy', 'placebo']","['Overall survival', 'risk of death', 'adverse events', 'median metastasis-free survival', 'time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy', 'incidence of adverse events', 'overall survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",1509.0,0.695659,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Ulys', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Polyakov', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jievaltas', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Le Berre', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Snapir', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001342']
1966,32930387,"Nintedanib plus mFOLFOX6 as second-line treatment of metastatic, chemorefractory colorectal cancer: The randomised, placebo-controlled, phase II TRICC-C study (AIO-KRK-0111).","Nintedanib is a triple angiokinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-3 and platelet-derived growth factor receptor-a/-b. Thereby, it targets angiogenic escape mechanisms. The trial TyRosine kinase Inhibitor for the treatment of Chemorefractory Colorectal Cancer (TRICC-C) trial evaluates the addition of nintedanib to mFOLFOX6 (fluorouracil, folinic acid and oxaliplatin) in patients with metastatic colorectal cancer (mCRC). TRICC-C is a randomised controlled, double-blinded, phase II trial in mCRC patients that received a first-line non-oxaliplatin containing chemotherapy. Patients received mFOLFOX6 + nintedanib (F + N) (2 × 200 mg p.o./d, d1-d14) or mFOLFOX6 + placebo (F + P), in a 1:1 ratio. Primary endpoint was median progression free survival (mPFS) and secondary overall response rate (ORR), overall survival (OS) and safety. Fifty-three patients (27 F + N; 26 F + P) were randomised between 12/2012 and 5/2016 (scheduled n = 180). The trial was terminated prematurely due to slow accrual. The trial did not reach its primary endpoint but mPFS, median overall survival (mOS) and disease control rate (DCR) were numerically higher in the F + N arm compared to the F + P arm; however, the difference was not significant (mPFS: F + P: 4.6 months vs F + N: 8.1 months; HR 0.65; 95% CI 0.32-1.30; P = .2156; mOS: F + P: 9.9 months vs F + N: 17.1 months; HR 1.03, 95% CI 0.48-2.23; P = .9387; DCR: F + P: 50% vs F + N: 66,7%; P = .2709). Toxicity was moderate and only different for neutropenia (F + P: 11.5%, F + N: 19.2%) and gastrointestinal disorders (F + P: 65.4%, F + N: 84.6%). Final results show safety and a nonsignificant trend towards improved PFS and DCR for the combination of mFOLFOX6 + nintedanib in the second-line therapy of mCRC.",2020,Final results show safety and a non-significant trend towards improved PFS and DCR for the combination of mFOLFOX6+nintedanib in the 2nd-line therapy of mCRC.,"['metastatic, chemorefractory colorectal cancer', '53 patients (27 F+N; 26 F+P) were randomized between 12/2012 to 5/2016 (scheduled n=180', 'patients with mCRC']","['mFOLFOX6+nintedanib (F+N) (2 x 200 mg p.o./d, d1-d14) or mFOLFOX6+placebo (F+P', 'mFOLFOX6+nintedanib', 'placebo', 'oxaliplatin containing chemotherapy', 'F+N', 'Nintedanib plus mFOLFOX6']","['mOS', 'Toxicity', 'gastrointestinal disorders', 'PFS and DCR', 'neutropenia', 'mPFS, mOS and disease control rate (DCR', 'mPFS and secondary overall response rate (ORR), overall survival (OS) and safety']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.390038,Final results show safety and a non-significant trend towards improved PFS and DCR for the combination of mFOLFOX6+nintedanib in the 2nd-line therapy of mCRC.,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Perkhofer', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Private Practice, Onkologie Ravensburg, Ravensburg, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Interdisciplinary Tumor Center, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Internal Medicine II, Klinikum Weimar, Weimar, Germany.'}, {'ForeName': 'Holger F', 'Initials': 'HF', 'LastName': 'Hebart', 'Affiliation': 'Medizinische Klinik, Klinikum Schwäbisch Gmünd, Stauferklinik, Mutlangen, Baden-Württemberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Herrmann', 'Affiliation': 'Medizinische Klinik, Westküstenklinikum Heide, Heide, Schleswig-Holstein, Germany.'}, {'ForeName': 'Carla V', 'Initials': 'CV', 'LastName': 'Hannig', 'Affiliation': 'Private Practice, Schwerpunktpraxis Hämatologie/Onkologie, Bottrop, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Büchner-Steudel', 'Affiliation': 'Internal Medicine I, Martin-Luther-University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Güthle', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Hermann', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, Delaware, USA.'}]",International journal of cancer,['10.1002/ijc.33296']
1967,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
1968,32932056,"Using Empathetic CAre and REsponse (ECARE) in improving empathy and confidence among nursing and medical students when managing dangerous, aggressive and violent patients in the clinical setting.","BACKGROUND


The use of physical restraint to curtail dangerous or extremely disruptive behaviours in patients has been an established practice to help ensuring safety in healthcare providers' work environment. However, many have deemed it unnecessary and overused with reported negligence on patients' basic needs during its implementation. Studies have shown that having empathy and non-judgmental attitudes are vital in reducing and eliminating the use of restraint.
OBJECTIVES


To explore whether experiential learning will improve empathy and confidence, among nursing and medical students when managing dangerous, aggressive, and violent patients.
DESIGN


A pre- and post-test, same group quasi-experimental design was used to explore the effectiveness of using the Empathetic CAre and REsponse (ECARE), an experiential learning session to equip nursing and medical students on managing dangerous, aggressive, and violent patients. Outcome measures include students' confidence when using verbal de-escalation, physical and chemical restraint techniques. Empathy scores were also compared.
SETTINGS


A University offering both medical and nursing program from undergraduate to postgraduate level.
PARTICIPANTS


249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education.
RESULTS


Results showed that, for both student populations, the empathy and confidence scores significantly improved after attending ECARE. ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
CONCLUSIONS


This study demonstrated that experiential learning could improve the learners' empathy through the integration of hands-on learning. This in turn could enhance future healthcare professionals' care quality. Experiential learning opportunities should be incorporated into existing pedagogies as this helps to improve students' confidence in managing dangerous, aggressive and violent patients, reducing the use of physical restraint, thereby enhancing the quality of patient care.",2020,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
",['249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education'],"['Empathetic CAre and REsponse (ECARE', 'experiential learning', 'Empathetic CAre and REsponse (ECARE), an experiential learning session']","['empathy and confidence scores', 'Empathy scores', ""students' confidence when using verbal de-escalation, physical and chemical restraint techniques""]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320374', 'cui_str': 'Chemical restraint'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",249.0,0.0260366,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
","[{'ForeName': 'Yong-Shian', 'Initials': 'YS', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore. Electronic address: nurgys@nus.edu.sg.'}, {'ForeName': 'Yu-Ting Michelle', 'Initials': 'YM', 'LastName': 'Seetoh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Mui-Lee', 'Initials': 'ML', 'LastName': 'Chng', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Siang Loong', 'Initials': 'SL', 'LastName': 'Ong', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Mental Health, Singapore.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Chun-Man Roger', 'Initials': 'CR', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Su Hui Cyrus', 'Initials': 'SHC', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}]",Nurse education today,['10.1016/j.nedt.2020.104591']
1969,32932174,"The effects of zinc supplementation on metabolic profile and oxidative stress in overweight/obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Evidence indicates the positive effects of zinc on insulin resistance and oxidative stress in metabolic syndrome or diabetes. Non-alcoholic fatty liver disease (NAFLD) is the main hepatic manifestation of insulin resistance and metabolic syndrome. The present study is the first clinical trial that evaluated the effects of zinc supplementation on metabolic and oxidative stress status in overweight/obese patients with NAFLD undergoing calorie- restriction diet.
METHODS


Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography were randomly allocated to receive 30 mg elemental zinc supplement (n = 29) or placebo (n = 27) along with weight loss diet for 12 weeks. Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels were assessed.
RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05). Within group comparison showed significant reduction in serum FBS, HbA 1C , TC, LDL-c and TG in the treatment group.
CONCLUSION


Zinc supplementation for three months improved insulin resistance and oxidative stress status in overweight/obese NAFLD patients with no beneficial effects on lipid profiles over weight loss diet. Registration ID in IRCT (IRCT NO: 20181005041238N1).",2020,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","['alcoholic fatty liver disease (NAFLD', 'overweight/obese patients with non-alcoholic fatty liver disease', 'metabolic syndrome or diabetes', 'overweight/obese patients with NAFLD undergoing calorie- restriction diet', 'overweight/obese NAFLD patients', 'Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography']","['Zinc supplementation', '30\u202fmg elemental zinc supplement', 'IRCT', 'placebo', 'zinc supplementation']","['Serum levels of insulin, SOD1, MDA and HOMA-IR', 'serum FBS, HbA 1C , TC, LDL-c and TG', 'metabolic and oxidative stress status', 'insulin resistance and oxidative stress status', 'Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels', 'metabolic profile and oxidative stress']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",56.0,0.385469,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: r_amani@mail.mui.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126635']
1970,32941794,"Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Unlike for extremity sarcomas, the efficacy of radiotherapy for retroperitoneal sarcoma is not established. The aim of this study was to evaluate the impact of preoperative radiotherapy plus surgery versus surgery alone on abdominal recurrence-free survival.
METHODS


EORTC-62092 is an open-label, randomised, phase 3 study done in 31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America. Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower, were centrally randomly assigned (1:1), using an interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery. Randomisation was stratified by hospital and performance status. Radiotherapy was delivered as 50·4 Gy (in 28 daily fractions of 1·8 Gy) in either 3D conformal radiotherapy or intensity modulated radiotherapy, and the objective of surgery was a macroscopically complete resection of the tumour mass with en-bloc organ resection as necessary. The primary endpoint was abdominal recurrence-free survival, as assessed by the investigator, and was analysed in the intention-to-treat population. Safety was analysed in all patients who started their allocated treatment. This trial is registered with ClinicalTrials.gov, NCT01344018.
FINDINGS


Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group. The median follow-up was 43·1 months (IQR 28·8-59·2). 128 (96%) patients from the surgery alone group had surgery, and 119 (89%) patients in the radiotherapy and surgery group had both radiotherapy and surgery. Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95). The most common grade 3-4 adverse events were lymphopenia (98 [77%] of 127 patients in the radiotherapy plus surgery group vs one [1%] of 128 patients in the surgery alone group), anaemia (15 [12%] vs ten [8%]), and hypoalbuminaemia (15 [12%] vs five [4%]). Serious adverse events were reported in 30 (24%) of 127 patients in the radiotherapy plus surgery group, and in 13 (10%) of 128 patients in the surgery alone group. One (1%) of 127 patients in the radiotherapy plus surgery group died due to treatment-related serious adverse events (gastropleural fistula), and no patients in the surgery alone group died due to treatment-related serious adverse events.
INTERPRETATION


Preoperative radiotherapy should not be considered as standard of care treatment for retroperitoneal sarcoma.
FUNDING


European Organisation for Research and Treatment of Cancer, and European Clinical Trials in Rare Sarcomas.",2020,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","['Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group', 'Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower', 'patients with primary retroperitoneal sarcoma (EORTC-62092', '31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America']","['interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery', 'Preoperative radiotherapy plus surgery versus surgery alone', '3D conformal radiotherapy or intensity modulated radiotherapy', 'Radiotherapy', 'radiotherapy', 'preoperative radiotherapy plus surgery versus surgery alone']","['Safety', 'lymphopenia', 'Serious adverse events', 'anaemia', 'Median abdominal recurrence-free survival', 'abdominal recurrence-free survival']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0585129', 'cui_str': 'Retroperitoneal sarcoma'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",266.0,0.228048,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Université Paris Sciences et Lettres, Paris, France. Electronic address: sylvie.bonvalot@curie.fr.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Swallow', 'Affiliation': 'Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Strauss', 'Affiliation': 'Department of Surgical Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stoldt', 'Affiliation': 'Department of Surgical Oncology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Stoeckle', 'Affiliation': 'Department of Surgical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Surgery, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Chandrajit P', 'Initials': 'CP', 'LastName': 'Raut', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Hompes', 'Affiliation': 'Department of Surgical Oncology, University Hospitals Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'De Paoli', 'Affiliation': 'Centro di Riferimento Oncologico CRO-IRCCS, Aviano, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sangalli', 'Affiliation': 'Department of Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Honoré', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Miah', 'Affiliation': 'Department of Radiation Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Stelmes', 'Affiliation': 'Quality Assurance in Radiotherapy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Medicine, University of Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Baldini', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Haas', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30446-0']
1971,32931950,Cell-Based Functional IgE Assays Are Superior to Conventional Allergy Tests for Shrimp Allergy Diagnosis.,"BACKGROUND


The diagnosis of shellfish allergy currently relies on patient history, skin prick test (SPT), and serum specific IgE (sIgE) quantification. These methods lack sufficient diagnostic accuracy, whereas the gold standard of oral food challenges is risky and burdensome. Markers of reactivity and severity of allergic reactions to shellfish will improve clinical care of these patients.
OBJECTIVES


This study compared the diagnostic performance of SPT, sIgE, basophil activation test (BAT), and IgE crosslinking-induced luciferase expression (EXiLE) test for shrimp allergy.
METHODS


Thirty-five subjects with documented history of shrimp allergic reactions were recruited and grouped according to results of double-blind, placebo-controlled food challenge (DBPCFC). In addition to routine diagnostics, BAT (Flow CAST) and EXiLE test with shrimp extract and tropomyosin were performed.
RESULTS


Of 35 subjects, 15 were shrimp allergic with pruritus, urticaria, and itchy mouth on DBPCFC, whereas 20 were tolerant to shrimp. Tropomyosin only accounted for 53.3% of sensitization among subjects with challenge-proven shrimp allergy. BAT using shrimp extract as stimulant showed the highest area under curve value (0.88), Youden Index (0.81), likelihood ratio (14.73), odds ratio (104), and variable importance (4.27) when compared with other assays and tropomyosin diagnosis. Results of BAT significantly correlated with those of EXiLE (r = 0.664, P < .0001).
CONCLUSIONS


BAT is a more accurate diagnostic marker for shrimp allergy than SPT and shrimp sIgE, whereas the EXiLE test based on an IgE crosslinking assay is a good alternative to BAT. Tropomyosin may not be the most important shrimp allergen in Chinese, which warrants further investigation to search for other major allergens and diagnostic markers.",2020,"BAT using shrimp extract as stimulant showed the highest AUC value (0.88), Youden index (0.81), likelihood ratio (14.73), odds ratio (104) and variable importance (4.27) when compared with other assays and tropomyosin diagnosis.","['subjects with challenge-proven shrimp allergy', 'Thirty-five subjects with documented history of shrimp allergic reactions']","['BAT', 'placebo-controlled food challenge (DBPCFC']","['shrimp-allergic with pruritus, urticaria and itchy mouth on DBPCFC', 'diagnostic performance of SPT, sIgE, basophil activation test (BAT) and IgE crosslinking-induced luciferase expression (EXiLE) test', 'highest AUC value']","[{'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024075', 'cui_str': 'Luciferase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",35.0,0.0361927,"BAT using shrimp extract as stimulant showed the highest AUC value (0.88), Youden index (0.81), likelihood ratio (14.73), odds ratio (104) and variable importance (4.27) when compared with other assays and tropomyosin diagnosis.","[{'ForeName': 'Christine Y Y', 'Initials': 'CYY', 'LastName': 'Wai', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Nicki Y H', 'Initials': 'NYH', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Agnes S Y', 'Initials': 'ASY', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shum', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Patrick S C', 'Initials': 'PSC', 'LastName': 'Leung', 'Affiliation': 'Division of Rheumatology, Allergy and Clinical Immunology, University of California, Davis, Calif.'}, {'ForeName': 'Ka Hou', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'School of Life Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yat Wah', 'Initials': 'YW', 'LastName': 'Kwan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Qun Ui', 'Initials': 'QU', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Joshua S C', 'Initials': 'JSC', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Ivan C S', 'Initials': 'ICS', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Pui Fung', 'Initials': 'PF', 'LastName': 'Li', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kary J Y', 'Initials': 'KJY', 'LastName': 'Xu', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Cheuk Yin', 'Initials': 'CY', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jinlyu', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Allergy and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College, Beijing, People's Republic of China; Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatology and Immunological Disease, Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment on Allergic Diseases, Beijing, People's Republic of China.""}, {'ForeName': 'Gary W K', 'Initials': 'GWK', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ting Fan', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong. Electronic address: tfleung@cuhk.edu.hk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.057']
1972,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: amohamed@gelisim.edu.tr.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
1973,32940769,"Retraction Note to: Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.",This article has been retracted. Please see the retraction notice for more detail: https://doi.org/10.1007/s00520-020-05770-w.,2020,"Following publication, concerns were raised with respect to data and data analyses present in the article.",['patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation'],['Bismuth adjuvant'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],,0.145238,"Following publication, concerns were raised with respect to data and data analyses present in the article.","[{'ForeName': 'Per Boye', 'Initials': 'PB', 'LastName': 'Hansen', 'Affiliation': 'Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Penkowa', 'Affiliation': 'Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05770-w']
1974,32945926,[Treatment of asymptomatic aortic stenosis : RECOVERY trial (randomized comparison of early surgery versus conventional treatment in very severe aortic stenosis)].,,2020,,"['asymptomatic aortic stenosis ', 'very severe aortic stenosis']",['early surgery versus conventional treatment'],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0233211,,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kutschka', 'Affiliation': 'Klinik für Thorax‑, Herz- und Gefäßchirurgie, Universitätsmedizin Göttingen, Georg-August-Universität, Robert-Koch-Str.\xa040, 37075, Göttingen, Deutschland. ingo.kutschka@med.uni-goettingen.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nitschmann', 'Affiliation': ', Lippetal, Deutschland.'}]",Der Internist,['10.1007/s00108-020-00868-z']
1975,32949091,Effects of branched-chain amino acids on postoperative tumor recurrence in patients undergoing curative resection for hepatocellular carcinoma: A randomized clinical trial.,"BACKGROUND/PURPOSE


No effective postoperative adjuvant therapies have been established for patients with hepatocellular carcinoma (HCC). The aim of this study was to investigate the effect of oral administration of branched-chain amino acids (BCAA) on the recurrence-free survival (RFS) after hepatic resection in HCC patients.
METHODS


In this randomized clinical trial, HCC patients undergoing curative resections were randomly assigned in a 1:1 ratio to the BCAA group or surgery-alone group. The BCAA group received BCAA (Livact ®  ) for up to 4 years. The primary endpoint was RFS. The secondary endpoint was overall survival (OS). Multivariate analysis was performed to detect the clinical characteristics significantly associated with RFS.
RESULTS


Between January 2010 and October 2014, 156 patients (75 in BCAA group and 81 in surgery-alone group) were enrolled in the study. Of these, two patients were excluded from the efficacy analysis. Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P = .579) or OS (P = .268) between the BCAA and the control group. Multivariate analysis revealed that the RFS was significantly associated with age and number of tumors. A beneficial effect of BCAA on the RFS was found in patients younger than 72 years old with a HbA1c level of < 6.4%.
CONCLUSIONS


Oral BCAA supplementation could not reduce the risk of recurrence after hepatic resection in HCC patients; however, the results suggested that BCAA supplementation may be beneficial for selected patients who were younger and had mildly impaired glucose tolerance.",2020,Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P=0.579) or OS (P=0.268) between the BCAA and the control group.,"['patients younger than 72 years old with a HbA1c level of <6.4', 'Between January 2010 and October 2014, 156 patients (75 in BCAA group and 81 in surgery-alone group) were enrolled in the study', 'HCC patients', 'Patients Undergoing Curative Resection for Hepatocellular Carcinoma', 'selected patients who were younger and had mildly impaired glucose tolerance', 'patients with hepatocellular carcinoma (HCC', 'HCC patients undergoing curative resections']","['branched-chain amino acids (BCAA', 'BCAA group or surgery-alone group', 'Branched-chain Amino Acids', 'BCAA supplementation', 'BCAA', 'BCAA (Livact ®  ']","['overall survival (OS', 'recurrence-free survival (RFS', 'risk of recurrence', 'survival curves', 'Postoperative Tumor Recurrence', 'RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}]",,0.152532,Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P=0.579) or OS (P=0.268) between the BCAA and the control group.,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hachiya', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Iso', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Tago', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kyung Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Yuhki', 'Initials': 'Y', 'LastName': 'Sakuraoka', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Shiraki', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.830']
1976,32947060,Changing the innate consensus about mesh fixation in trans-abdominal preperitoneal laparoscopic inguinal hernioplasty in adults: Short and long term outcome. Randomized controlled clinical trial.,"INTRODUCTION


Inguinal hernioplasty is the standard treatment for inguinal hernia in adults. Mesh fixation was used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair in adults, but their effectiveness has remained inconclusive.
AIM OF THE WORK


to evaluate non fixation method of mesh laparoscopic inguinal hernioplasty as safe and effective as regard short and long term outcomes.
PATIENTS AND METHODS


Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing Trans abdominal preperitoneal technique (TAPP) were randomized into 3 groups: Group A; mesh non fixation 266 patients. Group B; tacker mesh fixation 266 patients Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation 266 patients. Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.
RESULTS


There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score. In Group (B): the postoperative pain and complications were higher. There were 5 cases of hernia recurrence in all groups, but no significant differences among the three groups.
CONCLUSION


Tacker Mesh fixation increased the risk of chronic groin pain. Pain score was higher with tacker mesh fixation. Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation was safe and feasible with no significant increase in recurrence rates. Furthermore, mesh fixation with tacker procedure increased the risk of postoperative complications and patient costs. All ethical approval was given by our Faculty of Medicine medical ethical committee.",2020,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","['Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults', '266 patients Group C', 'Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing', 'inguinal hernia in adults', '266 patients']","['Cyanoacrylic tissue glues (Histoacryl) mesh fixation', 'Mesh Fixation', 'Inguinal hernioplasty', 'Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation', 'mesh non fixation', 'Mesh fixation', 'tacker mesh fixation', 'Tacker Mesh fixation', 'Trans abdominal preperitoneal technique (TAPP', 'laparoscopic inguinal hernioplasty', 'mechanical tacker fixation']","['risk of chronic groin pain', 'operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score', 'postoperative pain and complications', 'intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs', 'recurrence rates', 'hernia recurrence', 'Pain score', 'risk of postoperative complications and patient costs']","[{'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0019296', 'cui_str': 'Indirect inguinal hernia'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",798.0,0.0914316,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","[{'ForeName': 'Tamer A A M', 'Initials': 'TAAM', 'LastName': 'Habeeb', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt. Electronic address: tameralnaimy@hotmail.com.'}, {'ForeName': 'Mohammed Mahmoud', 'Initials': 'MM', 'LastName': 'Mokhtar', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Sieda', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Osman', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Abd-Elrahman M', 'Initials': 'AM', 'LastName': 'Metwalli', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Riad', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Osama M H', 'Initials': 'OMH', 'LastName': 'Khalil', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'Mansour', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Tamer Mohamed', 'Initials': 'TM', 'LastName': 'Elshahidy', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Moustafa B', 'Initials': 'MB', 'LastName': 'Mohamed', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.013']
1977,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
1978,32947176,Effectiveness of a school-based road safety educational program for lower secondary school students in Denmark: A cluster-randomized controlled trial.,"Road accidents are one of the leading causes of death and injuries among adolescents and young adults. Road safety education programs aim to promote safe traffic behavior through information, skills training or fear appeals. During the last decade, an intervention type using victim testimonials has been developed. These types of programs aim to promote road safety by connecting a personal narrative of choices and consequences to the beliefs and behaviors of the audience. Studies on the effectiveness of this type of road safety programs among youngsters who are not yet drivers are still limited. This study used a cluster-randomized and controlled trial design to examine the effect of a Danish school-based road safety educational program using testimonials for students in lower secondary schools in Denmark on a) knowledge of risks factors in traffic and b) two types of behavior specifically relevant for the pre-driver target group: seatbelt use and safe bicycle behavior. Our analysis sample comprised 1007 students from 57 schools with a matched baseline and four-month follow-up response. Linear regression analyses suggest a small positive effect on the students' knowledge of the three most important risk factors in traffic but not on the age group most at risk. Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use. Neither was the effectiveness modified by gender, parental educational background, or risky cycling behavior at baseline. Although classroom-based interventions using testimonials may have the potential to increase knowledge of risk factors in traffic among adolescents, translating knowledge into safe traffic behavior is challenging. More studies are needed on how to further adapt the intervention to an age group who are not yet drivers. Such research may focus on mechanisms of change including the age-specific relevance of the ambassador's testimonial and on employing strong elements of action guidance.",2020,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","['students in lower secondary schools in Denmark on a', 'lower secondary school students in Denmark', '1007 students from 57 schools with a matched baseline and four-month follow-up response', 'youngsters who are not yet drivers', 'adolescents and young adults']","['school-based road safety educational program', 'Danish school-based road safety educational program']","['effectiveness modified by gender, parental educational background, or risky cycling behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",1007.0,0.0370321,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","[{'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark.'}, {'ForeName': 'Signe Boe', 'Initials': 'SB', 'LastName': 'Rayce', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark. Electronic address: sbo@vive.dk.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105773']
1979,32949650,"Multimorbidity, glycaemic variability and time in target range in people with type 2 diabetes: A baseline analysis of the GP-OSMOTIC trial.","AIMS


To explore associations between multimorbidity condition counts (total; concordant (diabetes-related); discordant (unrelated to diabetes)) and glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR)) using data from a randomised controlled trial examining effectiveness of continuous glucose monitoring (CGM) in people with type 2 diabetes (T2D).
METHODS


Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) trial from 25 general practices in Australia. Number of long-term conditions (LTCs) in addition to T2D used to quantify total/concordant/discordant multimorbidity counts. GV (measured by coefficient of variation (CV)) and TIR derived from CGM data. Multivariable linear regression models used to examine associations between multimorbidity counts, HbA1c (%), GV and TIR.
RESULTS


Mean (SD) age of participants 60.4 (9.9) years; 40.9% female. Multimorbidity was present in 89.2% of participants. Most prevalent comorbid LTCs: hypertension (57.4%), painful conditions (29.8%), coronary heart disease (22.6%) and depression (19.0%). No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
CONCLUSIONS


While multimorbidity was common in this T2D cohort, it was not associated with HbA1c, CV or TIR. Future studies should explore factors other than glycaemia that contribute to the increased mortality observed in those with multimorbidity and T2D.",2020,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","['people with type 2 diabetes', 'Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring', 'Mean (SD) age of participants 60.4 (9.9) years; 40.9% female', '25 general practices in Australia', 'people with type 2 diabetes (T2D']",['continuous glucose monitoring (CGM'],"['Number of long-term conditions (LTCs', 'GV (measured by coefficient of variation (CV)) and TIR', 'coronary heart disease', 'multimorbidity counts, HbA1c, GV and TIR', 'glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR', 'Multimorbidity', 'HbA1c, CV or TIR', 'Multimorbidity, glycaemic variability and time in target range', 'multimorbidity counts, HbA1c (%), GV and TIR', 'painful conditions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",279.0,0.207765,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","[{'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia. Electronic address: jason.chiang@unimelb.edu.au.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': ""Department of Medicine, St Vincent's Hospital, University of Melbourne, Australia.""}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Bhautesh Dinesh', 'Initials': 'BD', 'LastName': 'Jani', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Barbara I', 'Initials': 'BI', 'LastName': 'Nicholl', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108451']
1980,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
1981,32935921,Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus.,"BACKGROUND


The literature regarding flash glucose monitoring (FGM)-associated cutaneous adverse events (AE) is limited.
OBJECTIVES


This study among youth participating in a 6 month randomized controlled trial aimed to compare cutaneous AE between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss.
METHODS


Patients aged 13 to 20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type, and severity of cutaneous AEs, and evaluate premature sensor loss.
RESULTS


Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group); however, the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = .004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate, and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6 months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE.
CONCLUSIONS


Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM.",2020,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","['Patients aged 13-20\u2009years with type 1 diabetes', 'Youth with Type 1 Diabetes Mellitus', 'youth participating in a six-month randomized controlled trial (RCT', 'Sixty-four participants were recruited; 33 randomized to']","['Flash Glucose Monitoring', 'intervention (FGM and usual care) or control (SMBG and usual care', 'FGM']","['proportion of participants experiencing cutaneous AEs', 'skin hardening', 'erythema', 'cutaneous adverse events (AE) between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss', 'premature sensor loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",64.0,0.0741514,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}]",Pediatric diabetes,['10.1111/pedi.13121']
1982,32949267,"A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.","PURPOSE


To compare pharmacokinetics, safety, tolerability, and immunogenicity between SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US).
METHODS


In this randomized, double-blind, parallel-group, and single-dose study, healthy volunteers were randomized to receive a 3 mg/kg dose of SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion. Primary endpoints were area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ). Bioequivalence was achieved if 90% confidence intervals (CIs) for the ratios of the geometric least squares means (LSMeans) of primary endpoints were within the predefined bioequivalence margins of 80.00-125.00%. Safety and immunogenicity were also investigated.
RESULTS


The 90% CIs for the geometric LSMean ratios of AUC inf , AUC last  and C max  were all within the prespecified bioequivalence margins. Geometric LSMean ratios for SB8/bevacizumab-EU, SB8/bevacizumab-US and bevacizumab-EU/bevacizumab-US were 88.01%, 88.48% and 100.54% for AUC inf , 88.65%, 89.08% and 100.49% for AUC last  and 99.59%, 101.15% and 101.56% for C max , respectively. Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%). Most TEAEs were mild and considered as not related to the study drug. No deaths or treatment discontinuations due to adverse events occurred. Incidence of anti-drug antibodies was also comparable between all groups and no neutralizing antibodies were detected.
CONCLUSION


This study demonstrated pharmacokinetic bioequivalence and similar safety and immunogenicity profiles of SB8 to both reference products, bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. CLINICALTRIALS.
GOV IDENTIFIER


NCT02453672 (submitted date); EudraCT number: 2015-001,026-41.",2020,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).",['healthy volunteers'],"['sb8 (bevacizumab biosimilar) with reference bevacizumab', 'bevacizumab-EU', 'SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion', 'bevacizumab', 'bevacizumab-EU/bevacizumab', 'bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US', 'European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US']","['geometric LSMean ratios of AUC inf , AUC last  and C max', 'neutralizing antibodies', 'Safety and immunogenicity', 'area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ', 'pharmacokinetics, safety, tolerability, and immunogenicity', 'Geometric LSMean ratios', 'Incidence of anti-drug antibodies']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.141577,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).","[{'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea. dh01.shin@samsung.com.'}, {'ForeName': 'Yoon Jung', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Dahyoung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Clinical Bioanalysis, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Minjeong', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Petkova', 'Affiliation': 'Clinical Pharmacology Unit, SGS LSS, Antwerpen, Lange Beeldekensstraat 267, 2060, Antwerpen, Belgium.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04144-7']
1983,32937045,"Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis.","BACKGROUND


In adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine), are unknown.
METHODS


In a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial conducted at 107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive intravenous belimumab (at a dose of 10 mg per kilogram of body weight) or matching placebo, in addition to standard therapy. The primary end point at week 104 was a primary efficacy renal response (a ratio of urinary protein to creatinine of ≤0.7, an estimated glomerular filtration rate [eGFR] that was no worse than 20% below the value before the renal flare (pre-flare value) or ≥60 ml per minute per 1.73 m 2  of body-surface area, and no use of rescue therapy), and the major secondary end point was a complete renal response (a ratio of urinary protein to creatinine of <0.5, an eGFR that was no worse than 10% below the pre-flare value or ≥90 ml per minute per 1.73 m 2 , and no use of rescue therapy). The time to a renal-related event or death was assessed.
RESULTS


A total of 448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group). At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02). The risk of a renal-related event or death was lower among patients who received belimumab than among those who received placebo (hazard ratio, 0.51; 95% CI, 0.34 to 0.77; P = 0.001). The safety profile of belimumab was consistent with that in previous trials.
CONCLUSIONS


In this trial involving patients with active lupus nephritis, more patients who received belimumab plus standard therapy had a primary efficacy renal response than those who received standard therapy alone. (Funded by GlaxoSmithKline; BLISS-LN ClinicalTrials.gov number, NCT01639339.).",2020,"At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02).","['patients with active lupus nephritis', '448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group', 'Lupus Nephritis', 'adults with active lupus nephritis', '107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive']","['standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine', 'standard therapy alone', 'placebo', 'Belimumab', 'intravenous belimumab', 'belimumab plus standard therapy']","['primary efficacy renal response', 'complete renal response', 'efficacy renal response (a ratio of urinary protein to creatinine of ≤0.7, an estimated glomerular filtration rate [eGFR', 'risk of a renal-related event or death', 'efficacy renal response', 'time to a renal-related event or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",448.0,0.62045,"At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02).","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Furie', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Brad H', 'Initials': 'BH', 'LastName': 'Rovin', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Houssiau', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Malvar', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Y K Onno', 'Initials': 'YKO', 'LastName': 'Teng', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Contreras', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Amoura', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Chi-Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Mittermayer B', 'Initials': 'MB', 'LastName': 'Santiago', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Green', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Christi', 'Initials': 'C', 'LastName': 'Kleoudis', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Burriss', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Barnett', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Roth', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}]",The New England journal of medicine,['10.1056/NEJMoa2001180']
1984,32938620,Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial.,"PURPOSE


To assess palbociclib in combination with trastuzumab with or without endocrine therapy in patients with HER2-positive advanced breast cancer.
PATIENTS AND METHODS


PATRICIA is a prospective, open-label, multicenter phase II trial. Patients had received 2-4 prior lines of anti-HER2-based regimens. Treatment consisted of palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab. The study was based on a Simon two-stage design comprising three cohorts: estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1), and ER-positive with letrozole (cohort B2). ER-positive patients were randomized to cohorts B1 or B2. Primary endpoint was progression-free survival rate at 6 months (PFS6). Secondary objectives included safety and evaluation of the PAM50 intrinsic subtypes.
RESULTS


Seventy-one patients were recruited ( n  = 15 in cohort A and 28 in each cohort B). The PFS6 rate in cohorts A, B1, and B2 was 33.3% (5/15), 42.8% (12/28), and 46.4% (13/28), respectively. Regarding safety, grade 1-2 and 3-4 toxicities occurred in 97.7% and 84.4% of patients, respectively. The most common grade 3-4 toxicities were neutropenia (66.4%) and thrombocytopenia (11.3%). Regarding PAM50, 59 (83.1%) tumors were profiled. Luminal disease defined by PAM50 was found independently associated with longer PFS compared with non-luminal disease (10.6 vs. 4.2 months median PFS; adjusted hazard ratio = 0.40;  P  = 0.003).
CONCLUSIONS


Palbociclib in combination with trastuzumab is safe and exhibits promising survival outcomes in trastuzumab pretreated ER-positive/HER2-positive advanced breast cancer with a PAM50 Luminal A or B subtype. The enrollment was stopped prematurely, and a new randomized cohort was opened in this population.",2020,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","['HER2-positive advanced breast cancer', '71 patients were recruited (n=15 in cohort A and 28 in each cohort B', 'patients with HER2-positive advanced breast cancer', 'ER-positive patients']","['trastuzumab with or without endocrine therapy', 'trastuzumab', 'Palbociclib and trastuzumab', 'palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab', 'estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1) and ER-positive with letrozole']","['safety and evaluation of the PAM50 intrinsic subtypes', 'progression-free survival rate', 'thrombocytopenia', 'PFS6 rate', 'neutropenia', 'toxicities']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",71.0,0.127422,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain. eva.ciruelos@gmail.com alprat@clinic.cat.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Escrivá-de-Romaní', 'Affiliation': ""Vall d' Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Madrid & Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Vazquez', 'Affiliation': ""Institut Català d'Oncologia, Hospitalet del Llobregat, Spain.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Perelló', 'Affiliation': 'Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garau', 'Affiliation': 'Hospital Son Llàtzer, Palma de Mallorca, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Melé', 'Affiliation': 'Hospital Universitari Sant Joan de Reus, Reus, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Martínez', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Madrid, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Serafin', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Echarri', 'Affiliation': 'Hospital Universitario Severo Ochoa, Madrid, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Centro Integral Oncológico Clara Campal HM (CIOCC), Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González-Farré', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Canes', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d' Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gonzalez', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain. eva.ciruelos@gmail.com alprat@clinic.cat.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0844']
1985,32940243,Demand for Cancer Screening Services: Results From Randomized Controlled Discrete Choice Experiments.,"OBJECTIVES


Low uptake of cancer screening services is a global concern. Our aim was to understand factors that influence the screening decision, including screening and treatment subsidies and a gain-frame message designed to present screening as a win-win.
METHODS


We analyzed preferences for mammography and Pap smear among women in Singapore by means of discrete choice experiments while randomly exposing half of respondents to a gain-framed public health message promoting the benefits of screening.
RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening. Respondents also underestimated the survival chances of screen-detected breast and cervical cancers.
CONCLUSIONS


Combined, these findings suggest that correcting misconceptions about screen-detected cancer prognosis or providing greater financial protection for those who test positive could be more effective and more cost-effective than subsidizing screening directly in increasing screening uptakes.",2020,"RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening.",['Cancer Screening Services'],[],['survival chances'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.117165,"RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening.","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bilger', 'Affiliation': 'Health Economics and Policy, Vienna University of Economics and Business, Vienna, Austria; Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore. Electronic address: marcel.bilger@wu.ac.at.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Özdemir', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.06.004']
1986,32942245,Evaluation of the symptom-focused health assessment and empathy program for undergraduate nursing students: A randomized controlled trial.,"BACKGROUND


Health assessments are a vital competency required of nurses. The more traditional ways of teaching and learning this skill require practice and are often limited by time constraints. With the rise of technology-based platforms, students can supplement their learning health assessment skills through other means, such as videos, that not only teach the steps but also allow them to learn in context.
OBJECTIVES


This study describes how a symptom-focused health assessment and empathy (SHAE) program, which primarily involves the use of a case-based health assessment video, was implemented and evaluated.
DESIGN


The study involved a single-centre, single-blind, parallel randomized controlled trial.
SETTINGS


The study was conducted at a university in Singapore.
PARTICIPANTS


Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study.
METHODS


Participants were randomized into one of the two parallel groups: the experimental group or the waitlisted control (WL) group. The experimental group received the SHAE program in addition to conventional learning methods (e-lectures, lab demonstration, and pair practice). The WL group received only the conventional learning methods. Pre- and post-test measures of the study variables such as knowledge, health assessment skills, confidence, empathy, and intention to learn were conducted. The WL group was given access to the SHAE program after the post-test. Analyses of covariance (ANCOVA) were used to compare the means of the study variables between the intervention and WL groups.
RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004). No significant differences in intention to learn and empathy between the two groups were found.
CONCLUSION


The use of a case-based video has the potential to be a valuable method of teaching health assessments in context to nursing students. The SHAE program has shown beneficial effects on students' knowledge, health assessment skills, and confidence. However, there was no effect on students' intentions to learn and their empathy. Further refinements of the program will need to focus on improving these domains.",2020,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","['Participants', 'university in Singapore', 'Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study', 'undergraduate nursing students']","['conventional learning methods', 'SHAE program', 'symptom-focused health assessment and empathy program', 'waitlisted control (WL']","['knowledge', 'knowledge, health assessment skills, confidence, empathy, and intention to learn', 'health assessment skills', 'intention to learn and empathy', ""students' intentions to learn and their empathy""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0319629,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","[{'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurch@nus.edu.sg.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Ignacio', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurimjj@nus.edu.sg.'}, {'ForeName': 'Piyanee', 'Initials': 'P', 'LastName': 'Yobas', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurpk@nus.edu.sg.'}]",Nurse education today,['10.1016/j.nedt.2020.104566']
1987,32945536,Intravenous Alcohol Administration Selectively Decreases Rate of Change in Elasticity of Demand in Individuals With Alcohol Use Disorder.,"BACKGROUND


Alcohol demand is a key behavioral economic concept that provides an index of alcohol's relative reinforcing value. Initial studies have reported that alcohol demand increases during alcohol administration and in response to alcohol cues. However, the extent to which these effects are observed explicitly in samples composed of individuals with alcohol use disorder (AUD) and are operative in conjunction with each other has not been studied.
METHODS


To address this gap in the literature, we assessed alcohol demand during an alcohol challenge and subsequent alcohol cue-exposure paradigm in non-treatment-seeking, alcohol-dependent (i.e., DSM-IV criteria) participants (N = 27). Specifically, participants completed 2 counterbalanced intravenous, placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm. At baseline and at breath alcohol concentration of 0.06 g/dl, participants completed the alcohol purchase task, assessing estimated alcohol consumption at escalating prices. Participants were also assessed for alcohol demand following each cue exposure.
RESULTS


During alcohol administration, there was a significant decrease in the rate of change in elasticity compared with placebo, and during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased the rate of change in elasticity relative to water cues. There were no statistically significant differences in other demand indices.
CONCLUSIONS


These findings provide further evidence that alcohol administration increases price insensitivity and extends the literature on alcohol's effects on demand by using a clinical sample with AUD and by adding a placebo-alcohol condition.",2020,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","['Individuals with Alcohol Use Disorder', 'non-treatment seeking, alcohol dependent (i.e., DSM-IV criteria) participants (N = 27']","['placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm']","['rate of change in elasticity', 'elasticity relative to water cues', 'Rate of Change in Elasticity of Demand']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",27.0,0.0258914,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Nieto', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, (JM), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14460']
1988,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND


There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE


The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS


183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING


The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD


Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS


Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS


While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
1989,32948386,Correlation between Post-Procedure Residual Thrombus and Clinical Outcome in Deep Vein Thrombosis Patients Receiving Pharmacomechanical Thrombolysis in a Multicenter Randomized Trial.,"PURPOSE


To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT).
MATERIALS AND METHODS


Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months.
RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux.
CONCLUSIONS


PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.",2020,"RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","['Deep Vein Thrombosis Patients Receiving', 'Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multi-center randomized trial were reviewed']","['Pharmacomechanical Thrombolysis', 'pharmacomechanical catheter-directed thrombolysis (PCDT']","['visual assessments of thrombus regression and venous flow', '24-month Villalta post-thrombotic syndrome (PTS) severity score', 'substantial thrombus removal', 'symptom severity scores', '12-month valvular reflux', 'venous disease-specific quality of life (QOL) scores', 'spontaneous venous flow', 'Quantitative thrombus resolution', 'venous QOL']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0429874', 'cui_str': 'Venous flow'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0277919', 'cui_str': 'Venous stasis syndrome'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",317.0,0.0542837,"RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","[{'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, California.""}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lancia', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, McGill University, Division of Internal Medicine & Center for Clinical Epidemiology, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Weinberg', 'Affiliation': 'Vascular Medicine Section, Cardiology Division, Vascular Ultrasound Core Laboratory (VasCore), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Ezana M', 'Initials': 'EM', 'LastName': 'Azene', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Nilesh H', 'Initials': 'NH', 'LastName': 'Patel', 'Affiliation': 'Total Vascular Care Centers LLC, Peoria, Arizona.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, 510 S. Kingshighway Blvd., Box 8131, St. Louis, MO, 63110. Electronic address: vedanthams@wustl.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.07.010']
1990,32946924,"Sacituzumab Govitecan in Previously Treated Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Final Results from a Phase 1/2, Single-Arm, Basket Trial.","BACKGROUND


Trophoblast cell-surface antigen-2 (Trop-2) is expressed in epithelial cancers, including hormone receptor-positive (HR+) metastatic breast cancer (mBC). Sacituzumab govitecan (SG; Trodelvy™) is an antibody-drug conjugate composed of a humanized anti-Trop-2 monoclonal antibody coupled to SN-38 at a high drug:antibody ratio via a unique hydrolyzable linker that delivers SN-38 intracellularly and in the tumor microenvironment. SG was granted accelerated FDA approval for metastatic triple-negative BC treatment in April 2020.
PATIENTS AND METHODS


We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received intravenous SG (10 mg/kg) and whose disease progressed on endocrine-based therapy and at least one prior chemotherapy for mBC. Endpoints included objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


Fifty-four women were enrolled between February 13, 2015 and June 1, 2017. Median (range) age was 54 (33-79) and all received at least two prior lines of therapy for mBC. At data cut-off (March 1, 2019), 12 patients were still alive. Key grade ≥3 treatment-related toxicities included neutropenia (50.0%), anemia (11.1%), and diarrhea (7.4%). Two patients discontinued treatment due to treatment-related adverse events. No treatment-related deaths occurred. At a median follow-up of 11.5 months, the ORR was 31.5% (95% confidence interval [CI], 19.5%-45.6%; 17 partial responses); median DOR was 8.7 months (95% CI, 3.7-12.7), median PFS was 5.5 months (95% CI, 3.6-7.6), and median OS was 12 months (95% CI, 9.0-18.2).
CONCLUSIONS


SG shows encouraging activity in patients with pretreated HR+/HER2- mBC and a predictable, manageable safety profile. Further evaluation in a randomized phase 3 trial (TROPiCS-02) is ongoing (NCT03901339).",2020,No treatment-related deaths occurred.,"['Fifty-four women were enrolled between February 13, 2015 and June 1, 2017', 'We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received']","['Sacituzumab Govitecan', 'intravenous SG', 'endocrine-based therapy and at least one prior chemotherapy for mBC']","['diarrhea', 'ORR', '17 partial responses); median DOR', 'anemia', 'toxicities included neutropenia', 'median OS', 'median PFS', 'objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C4086837', 'cui_str': 'sacituzumab govitecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.128403,No treatment-related deaths occurred.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kalinsky', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center-Herbert Irving Comprehensive Cancer Center, New York, NY. Electronic address: kk2693@cumc.columbia.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Diamond', 'Affiliation': 'Department of Medicine, Medical Oncology, University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Vahdat', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology, Baylor University Medical Center, US Oncology, Dallas, TX.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Moroose', 'Affiliation': 'Department of Hematology/Oncology, Orlando Health UF Health Cancer Center, Orlando, FL.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Goldenberg', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Sharkey', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maliakal', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hong', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goswami', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wegener', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.004']
1991,32946978,Sensory attributes of coated tablets: Developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
1992,32939904,Hypochlorous acid water prevents postoperative intrauterine infection after microwave endometrial ablation.,"AIM


We investigated the effects of uterine cavity lavage using hypochlorous acid water (HClO) on preventing postoperative intrauterine infection after microwave endometrial ablation (MEA).
METHODS


Four hundred and eleven consecutive patients were enrolled in this study. The patients were divided into two groups: 214 cases in 2014-2016 with disinfection using povidone-iodine antiseptic solution alone (group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (group B). HClO was used at a concentration of 200 ppm of residual chlorine. One gram of Ceftriaxone Sodium Hydrate was administered by drip infusion during MEA in both groups. Oral antibiotics were administered after MEA only in group A but not in group B.
RESULTS


Mean patient age (mean ± SD; years old) was 44.5 ± 4.6 in group A and 44.8 ± 5.4 in group B, and mean operation time (min) was 30.4 ± 19.1 in group A and 34.4 ± 22.6 in group B, respectively. Neither were significantly different between groups. The combined ablation techniques i.e. transcervical microwave myolysis and transcervical microwave adenomyolysis did not increase frequency of infection. Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases) (Chi-square test, P = 0.001). Hysterectomy was performed in three severe intrauterine infection cases in group A, but no cases of severe intrauterine infection was found in group B. No adverse effect of HClO was seen.
CONCLUSION


Intrauterine douche using HClO decreases postoperative intrauterine infection after MEA.",2020,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"['patients were divided into two groups: 214 cases in 2014-2016 with', 'after microwave endometrial ablation (MEA', 'Group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (Group B', 'Four hundred and eleven consecutive patients were enrolled in this study']","['HClO', 'Oral antibiotics', 'Hypochlorous acid water', 'uterine cavity lavage using hypochlorous acid water (HClO', 'Ceftriaxone Sodium Hydrate', 'disinfection using povidone-iodine antiseptic solution alone']","['Postoperative intrauterine infection cases', 'postoperative intrauterine infection', 'mean operation time', 'adverse effect of HClO', 'severe intrauterine infection', 'frequency of infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0150554', 'cui_str': 'Douche'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0700527', 'cui_str': 'Ceftriaxone sodium'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",411.0,0.0224565,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuda', 'Affiliation': 'Sanno Ladies Clinic, Akita, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kanaoka', 'Affiliation': 'Department of Gynecology, Iseikai Hospital, Osaka, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14471']
1993,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND


Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS


A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS


The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS


Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Project Coordinator at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
1994,32947474,A Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety.
DESIGN


Prospective randomized controlled trial.
SETTING


ICUs of two Italian referral extracorporeal membrane oxygenation centers.
PATIENTS


Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation.
INTERVENTIONS


Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups.
CONCLUSIONS


Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.",2020,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"['adult patients on venovenous extracorporeal membrane oxygenation', 'adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure', 'ICUs of two Italian referral extracorporeal membrane oxygenation centers', 'Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis', 'Adult patients requiring', 'for severe respiratory failure and unfractionated heparin for systemic anticoagulation']","['venovenous extracorporeal membrane oxygenation', 'Antithrombin supplementation', 'antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course', 'Antithrombin Supplementation', 'antithrombin supplementation', 'antithrombin']","['Antithrombin', 'anti-Factor Xa levels', 'risk of bleeding', 'bleeding and/or thrombosis', 'heparin dose, adequacy of anticoagulation, and safety', 'total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2', 'anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused', 'Bleeding, blood product transfusions, and thrombosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0427612', 'cui_str': 'Anti factor Xa measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1272061', 'cui_str': 'Activated partial thromboplastin time ratio'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.267968,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Panigada', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cucino', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Occhipinti', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Panarello', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Novembrino', 'Affiliation': ""Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ""Epidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Protti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arcadipane', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004590']
1995,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
1996,32947558,Population Pharmacokinetic Modeling of Vancomycin in Thai Patients with Heterogeneous and Unstable Renal Function.,"BACKGROUND


Vancomycin is widely used to treat gram-positive bacterial infections. However, given significant interpatient variability in its pharmacokinetics, maintaining plasma concentrations is difficult within its characteristically narrow therapeutic window. This is especially challenging in patients with unstable renal function. Thus, the aim of this study was to develop a population pharmacokinetic model for vancomycin that is suitable for Thai patients with variable renal functions, including those with unstable renal function.
METHODS


Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment. The model building group was randomly assigned 108 patients and the remaining 33 patients comprised the validation group. A population pharmacokinetic model was developed that incorporated drug clearance (CL) as a function of time-varying creatine clearance (CrCL). The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
RESULTS


A two-compartment model with drug CL values that changed with time-varying CrCL adequately described vancomycin pharmacokinetics in the evaluated heterogeneous patient population with unstable renal function. Vancomycin CL was related to time-varying CrCL as follows: CL(t)=0.11+0.021×CrCL(t) (CrCL < 120 mL/min). Using the population model, Bayesian estimation with at least one measured serum concentration resulted in a forecasting error of small bias (-2.4%) and adequate precision (31.5%).
CONCLUSION


In hospitals with a high incidence of unstable renal function, incorporating time-varying CrCL with Bayesian estimation and at least one measured drug concentration, along with frequent CrCL monitoring, improves the predictive performance of therapeutic drug monitoring of vancomycin.",2020,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","['Thai Patients with Heterogeneous and Unstable Renal Function', 'heterogeneous patient population with unstable renal function', 'patients with unstable renal function', 'Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment', 'Thai patients with variable renal functions, including those with unstable renal function']","['Vancomycin CL', 'Vancomycin', 'vancomycin']",[],"[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",[],108.0,0.0230478,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","[{'ForeName': 'Siriluk', 'Initials': 'S', 'LastName': 'Jaisue', 'Affiliation': 'Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Cholatip', 'Initials': 'C', 'LastName': 'Pongsakul', 'Affiliation': '(Certificate Board of Nephrology), Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Simulations Resource, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Pakawadee', 'Initials': 'P', 'LastName': 'Sermsappasuk', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000801']
1997,32949786,Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil.,"INTRODUCTION AND OBJECTIVES


Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis.
PATIENTS AND METHODS


EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored.
RESULTS


100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported ≥1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed.
CONCLUSIONS


Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03219216.",2020,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"['naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis', 'Treatment-Naïve Adults with Chronic Hepatitis C Virus Genotypes 1-6 in Brazil', 'treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis', 'naïve Brazilian adults with hepatitis C infection genotype 1-6', '100 patients', 'Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4', 'Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir']","['glecaprevir/pibrentasvir', 'Glecaprevir/Pibrentasvir', 'Glecaprevir/pibrentasvir']","['effective and well tolerated', 'treatment virologic failure and relapse rates', 'safety and efficacy', 'Efficacy and Safety', 'baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities', 'rate of sustained virologic response', 'hepatic decompensations', 'NS3 and NS5A. Adverse events and laboratory abnormalities', 'Overall sustained virologic response', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.0808733,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Peribañez-Gonzalez', 'Affiliation': 'Hospital Dia, Av Dr Arnaldo, 165, Segundo andar, São Paulo, Brazil. Electronic address: mpgonzalez@terra.com.br.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cheinquer', 'Affiliation': 'Ramiro Barcelos 2350, CPC Sala, 21216, Porto Alegre, Brazil. Electronic address: drhugo@terra.com.br.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: lino.rodrigues@abbvie.com.'}, {'ForeName': 'Maria Patelli', 'Initials': 'MP', 'LastName': 'Lima', 'Affiliation': 'Instituto de Infectologia Campinas, Rua Dr. Quirino, 524, Sala 72, Centro, Campinas, Brazil. Electronic address: mariapatelli@uol.com.br.'}, {'ForeName': 'Mário Reis', 'Initials': 'MR', 'LastName': 'Álvares-da-Silva', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, GI/Liver Division, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: marioreis@live.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Madruga', 'Affiliation': 'Rua Santa Cruz, 81, Vila Mariana, São Paulo, Brazil. Electronic address: valdezmr@uol.com.br.'}, {'ForeName': 'Edison Roberto', 'Initials': 'ER', 'LastName': 'Parise', 'Affiliation': 'Rua Diogo de Faria, 816 - Vila Clementino, São Paulo, Brazil. Electronic address: parise@sbhepatologia.org.br.'}, {'ForeName': 'Mário Guimarães', 'Initials': 'MG', 'LastName': 'Pessoa', 'Affiliation': 'Division of Gastroenterology and Hepatology University of São Paulo School of Medicine, Avenida Enéas de Carvalho Aguiar, 255 - Bloco B - 4º andar, São Paulo, Brazil. Electronic address: mgpessoa@uol.com.br.'}, {'ForeName': 'Juvencio', 'Initials': 'J', 'LastName': 'Furtado', 'Affiliation': 'Rua Cônego Xavier, 276 - Amb de Infectologia, São Paulo, Brazil. Electronic address: juvencio.furtado@terra.com.br.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Villanova', 'Affiliation': 'Hospital das ClÍnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Campus Universitário s/n, Monte Alegre, Bloco G Subsolo 2, Unidade de Pesquisa Clinica, Ribeirão Preto, Brazil. Electronic address: marciagvillanova@gmail.com.'}, {'ForeName': 'Adalgisa', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'Centro de Pesquisa Clínica Hospital Universitario da Universidade Federal do Maranhão, Rua Almirante Tamandaré, 01. Centro, São Luís, Brazil. Electronic address: adalgisaf@terra.com.br.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Mazzoleni', 'Affiliation': 'Hospital Ernesto Dornelles, Av. Ipiranga 1801, 7ºAndar, Cpda-Pesquisa, Porto Alegre, Brazil. Electronic address: fimazzoleni@hotmail.com.'}, {'ForeName': 'Ecio', 'Initials': 'E', 'LastName': 'Nascimento', 'Affiliation': 'Av. Mandacaru, 1590, Maringá, Brazil. Electronic address: eanascimento@uem.br.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Unesp Campus de Botucatu, Rua Prof Dr Armanda Alves, s/n(0) Bairro: Botucatu, Brazil. Electronic address: Giovanni.f.silva@unesp.br.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Fredrick', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: linda.m.fredrick@abbvie.com.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Preethi.krishnan@abbvie.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burroughs', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Margaret.burroughs@abbvie.com.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Reuter', 'Affiliation': 'Marechal Campos Av. 1355, Outclinic number 5, Vitoria, Brazil. Electronic address: tania.reuter@gmail.com.'}]",Annals of hepatology,['10.1016/j.aohep.2020.09.002']
1998,32949991,Motor imagery combined with action observation training optimized for individual motor skills further improves motor skills close to a plateau.,"The acquisition of high-level motor skills beyond a ""plateau"" is important in sports training and rehabilitation. We aimed to investigate whether motor skills close to a plateau state can be improved further by performing motor imagery (MI) training while observing movements with difficulty levels optimized for individual motor skills. The subjects were divided randomly into four groups (n = 10 per group): the control group and three groups of MI combined with action observation (MI + AO) training with varying difficulty levels. The task was to rotate the two cork balls 20 times counterclockwise using the left hand. The subjects performed 30 and 10 successful trials of this task before and after MI + AO training, respectively. In the three training groups, MI training was performed while observing videos showing ball rotation movements adjusted to the same level, a moderately higher level, or a remarkably higher level of difficulty than that achieved by the individual subjects. The improvement rate of the ball rotation time after MI + AO training was significantly higher in the moderate-difficulty than in the control group and remarkably higher level of difficulty group. The other two MI + AO training groups did not differ significantly compared with the control group. The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group. These results suggest that performing MI training while observing movement at a level that is moderately higher than an individual's ability can promote improvements in motor skills (close to a plateau state) in rehabilitation and sports training. The vividness of MI may be an important index for determining the difficulty level of the movement to be observed during MI + AO training.",2020,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,[],"['MI training', 'MI combined with action observation (MI\xa0+\xa0AO) training with varying difficulty levels', 'Motor imagery combined with action observation training', 'motor imagery (MI) training']","['motor skills', 'vividness of the MI during MI\xa0+\xa0AO training', 'motor skills close', 'improvement rate of the ball rotation time after MI\xa0+\xa0AO training']",[],"[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0112839,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: aoyamato@ipu.ac.jp.'}, {'ForeName': 'Fuminari', 'Initials': 'F', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan. Electronic address: f-kaneko@keio.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kohno', 'Affiliation': 'Centre for Medical Sciences, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: kohno@ipu.ac.jp.'}]",Human movement science,['10.1016/j.humov.2020.102683']
1999,32953086,Evaluation and pilot implementation of essential interventions for the management of hypertension and prevention of cardiovascular diseases in primary health care in the Republic of Tajikistan.,"Background:  Non-communicable diseases (NCDs) are the leading cause of death worldwide and are a major burden in Tajikistan. The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure. The aim of this study is to determine the feasibility of implementing and evaluating essential interventions for the management of hypertension and prevention of cardiovascular disease in primary health care in Tajikistan.  Methods and analysis:  A pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands will be used with greater weighting of the quantitative strand. A single geographic district was nominated by the Ministry of Health and chosen for implementation. All primary health care centres in the district that meet inclusion criteria will be included; half will be randomly assigned to the intervention arm and half to the control arm. The overall process is organized into seven steps: (1) refresh clinical decision-making tools including open source WHO PEN and HEARTS resources; (2) update training package for primary health care workers; (3) collection of baseline data; (4) training staff in intervention clinics; (5) implementation of protocols and implementation coaching; (6) collection of follow-up data after 12 months; (7) evaluation of results and sharing experience.  Ethics and dissemination:  Ethical review and approval have been obtained. Findings will be disseminated at the participant level, national level through a national conference of key stakeholders, and internationally through publication in an open-access peer review journal.",2019,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","['All primary health care centres in the district that meet inclusion criteria will be included; half', 'primary health care in Tajikistan', 'primary health care in the Republic of Tajikistan']",['essential interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039247', 'cui_str': 'Tajikistan'}]","[{'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0401091,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","[{'ForeName': 'Dylan R J', 'Initials': 'DRJ', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Helsinki, Finland.'}, {'ForeName': 'Mekhri', 'Initials': 'M', 'LastName': 'Shoismatuloeva', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Isfandiyor', 'Initials': 'I', 'LastName': 'Mahmudzoha', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Zakriya', 'Initials': 'Z', 'LastName': 'Rahimov', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Dilorom', 'Initials': 'D', 'LastName': 'Sultonova', 'Affiliation': 'Service of State Supervision for Medical Activities and Social Protection of the Population of the Republic of Tajikistan, Dushanbe, Tajikistan.'}, {'ForeName': 'Bunafsha', 'Initials': 'B', 'LastName': 'Jonova', 'Affiliation': 'Republican Clinical and Training Centre of Family Medicine, Dushanbe, Tajikistan.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",F1000Research,['10.12688/f1000research.20234.1']
2000,32954885,Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease.,"Background Cardiac rehabilitation is an established performance measure for adults with ischemic heart disease, but patient participation is remarkably low. Home-based cardiac rehabilitation (HBCR) may be more practical and feasible, but evidence regarding its efficacy is limited. We sought to compare the effects of HBCR versus facility-based cardiac rehabilitation (FBCR) on functional status in patients with ischemic heart disease. Methods and Results This was a pragmatic trial of 237 selected patients with a recent ischemic heart disease event, who enrolled in HBCR or FBCR between August 2015 and September 2017. The primary outcome was 3-month change in distance completed on a 6-minute walk test. Secondary outcomes included rehospitalization as well as patient-reported physical activity, quality of life, and self-efficacy. Characteristics of the 116 patients enrolled in FBCR and 121 enrolled in HBCR were similar, except the mean time from index event to enrollment was shorter for HBCR (25 versus 77 days;  P <0.001). As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001). After adjusting for demographics, comorbid conditions, and indication, the mean change in 6-minute walk test distance remained significantly greater for patients enrolled in HBCR (+101 versus +40 m;  P <0.001). HBCR participants reported greater improvements in quality of life and physical activity but less improvement in exercise self-efficacy. There were no deaths or cardiovascular hospitalizations. Conclusions Patients enrolled in HBCR achieved greater 3-month functional gains than those enrolled in FBCR. Our data suggest that HBCR may safely derive equivalent benefits in exercise capacity and overall program efficacy in selected patients. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02105246.",2020,"As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001).","['patients with ischemic heart disease', 'Patients With Ischemic Heart Disease', '116 patients enrolled in FBCR and 121 enrolled in HBCR', '237 selected patients with a recent ischemic heart disease event, who enrolled in HBCR or FBCR between August 2015 and September 2017', 'adults with ischemic heart disease']","['HBCR', 'Home-based cardiac rehabilitation (HBCR', 'HBCR versus facility-based cardiac rehabilitation (FBCR', ' Cardiac rehabilitation', 'Home-Based Cardiac Rehabilitation']","['3-month change in distance completed on a 6-minute walk test', 'exercise capacity and overall program efficacy', '6-minute walk test distance', 'quality of life and physical activity', 'rehospitalization as well as patient-reported physical activity, quality of life, and self-efficacy', 'exercise self-efficacy', 'mean change in 6-minute walk test distance', 'deaths or cardiovascular hospitalizations', '3-month functional gains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",237.0,0.104893,"As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001).","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Schopfer', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Whooley', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allsup', 'Affiliation': 'Department of Medicine VA Pittsburgh Healthcare System Pittsburgh PA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pabst', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tarasovsky', 'Affiliation': 'Department of Medicine San Francisco VA Health Care System San Francisco CA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Duvernoy', 'Affiliation': 'Division of Cardiology Department of Medicine University of Michigan Ann Arbor MI.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forman', 'Affiliation': 'Department of Medicine VA Pittsburgh Healthcare System Pittsburgh PA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016456']
2001,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
2002,32951002,The effect of intranasal oxytocin on visual processing and salience of human faces.,"The mechanisms underlying the role of oxytocin (OT) as a regulator of social behavior in mammals are only partly understood. Recently, it has been proposed that OT increases the salience of social stimuli. We carried out a randomized, double-blind, cross-over study of the effects of OT on binocular rivalry, a visual phenomenon underpinned by the interplay of excitation and inhibition in the cortex. A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches). We demonstrate a robust effect that intranasal OT increases the salience of human faces in binocular rivalry, such that dominance durations of faces are longer-this effect is not modulated by the facial expression. We tentatively show that OT treatment increases dominance durations for non-social stimuli. Our results lend support to the social salience hypothesis of OT, and in addition offer provisional support for the role of OT in influencing excitation-inhibition balance in the brain.",2020,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,['45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches'],"['OT', 'intranasal OT', 'intranasal oxytocin', 'oxytocin (OT']",['visual processing and salience of human faces'],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",45.0,0.0455496,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hovey', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. daniel.hovey@neuro.gu.se.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Martens', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Leknes', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Westberg', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-00991-3']
2003,32951708,The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial.,"OBJECTIVES


Local anesthetic and antinociceptive activity of eugenol, as the main ingredient of clove, was determined in previous researches. This study aimed to assess the efficacy of its topical nanoemulsion gel vs. placebo in controlling pain caused by arteriovenous fistula (AVF) needling in patients undergoing hemodialysis (HD).
DESIGN


In this double-blinded cross-over trial, the patients were randomly allocated to eugenol gel 4% (n = 34) and placebo gel (n  = 34) groups. For each patient, a tip of finger unit of gel was applied 2 cm around the insertion site of hemodialysis needles. After 10 min, AVF needling was done. AVF needling-related pain was assessed using visual analogue scale (VAS) immediately after the puncture. All patients were tested at three different states: (1) before using any intervention; (2) after using either the eugenol or placebo gel; and (3) after crossing over the groups.
RESULTS


There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001). It was reported as low as 3.29 ± 0.67 in patients who received eugenol nanoemulsion. Also, the highest pain severity score (5.03 ± 0.57) was reported at the no-intervention state.
CONCLUSIONS


It seems that topical application of eugenol nanoemulsion may significantly decrease AVF cannulation related pain intensity score in patients undergoing HD. However, further studies with larger sample size and longer intervention period should be done for better judgment on its efficiency and safety.",2020,There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001).,"['hemodialysis patients', 'patients undergoing HD', 'patients undergoing hemodialysis (HD']","['eugenol gel', 'AVF needling', 'eugenol nanoemulsion', 'placebo gel', 'eugenol or placebo gel', 'topical nanoemulsion gel vs. placebo']","['visual analogue scale (VAS', ""mean of patients' pain severity score"", 'AVF needling-related pain', 'highest pain severity score', 'AVF cannulation related pain intensity score', 'pain']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015153', 'cui_str': 'Eugenol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.232089,There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maghbool', 'Affiliation': 'Department of Pathology, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Tomaj', 'Initials': 'T', 'LastName': 'Khosravi', 'Affiliation': 'Student Research Committee, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Vojdani', 'Affiliation': 'Department of Anesthesiology, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Mahsa Rostami', 'Initials': 'MR', 'LastName': 'Chaijan', 'Affiliation': 'Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Esmaeili', 'Affiliation': 'Department of Medical Nanotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Amani', 'Affiliation': 'Natural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rezayat', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nasimi Doost Azgomi', 'Affiliation': 'Traditional Medicine, Hydrotherapy Research Center, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Shadan S', 'Initials': 'SS', 'LastName': 'Mehraban', 'Affiliation': 'Department of Obstetrics and Gynecology, Richmond University Medical Center, Staten Island, NY, USA.'}, {'ForeName': 'Mohammad Hashem', 'Initials': 'MH', 'LastName': 'Hashempur', 'Affiliation': 'Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran; Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa, Iran. Electronic address: hashempur@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102440']
2004,32951754,The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial.,,2020,,['hemodialysis patients'],['eugenol nanoemulsion'],['pain'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015153', 'cui_str': 'Eugenol'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.418149,,"[{'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Mansori', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: kamyarmansori@yahoo.com.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Soltani-Kermanshahi', 'Affiliation': 'Social Determinants of Health Research Center, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: msoltani@semums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102506']
2005,32949145,D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.,"BACKGROUND/OBJECTIVES


Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown.
DESIGN


Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.
SETTING


Four clinical trial sites (CTSs) based in academic and clinical health systems.
PARTICIPANTS


A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers.
INTERVENTIONS


Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline.
MEASUREMENTS


Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.
SECONDARY OUTCOMES


NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, ""time spent at home,"" Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims.
RESULTS


The results will be reported in the spring of 2024.
CONCLUSION


D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.",2020,"NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms.","['4 clinical trial sites (CTS) based in academic and clinical health systems', 'persons living with dementia (PWD) and their family or friend caregivers', ""Eighteen months of 1) Health systems-based dementia care provided by a nurse practitioner or physician's assistant Dementia Care Specialist who works within the health system, or 2"", '2,150 English- or Spanish-speaking PWD, who are not receiving hospice or residing in a nursing home, and their caregivers']","[""Community-based dementia care provided by a social worker or nurse Care Consultant who works at a community-based organization, or 3) Usual care with as-needed referral to the Alzheimer's Association Helpline"", 'Health System-based versus Community-based Dementia Care versus Usual Dementia Care']","['NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms', 'PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales', 'Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, ""time spent at home"", Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost-effectiveness using intervention costs and Medicare claims']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]",,0.0582374,"NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms.","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Lichtenstein', 'Affiliation': 'Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Jennings', 'Affiliation': 'Department of Medicien, Reynolds Section of Geriatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Zaldy', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Evertson', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bass', 'Affiliation': 'Center for Research and Education, Benjamin Rose Institute on Aging, Cleveland, Ohio, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Weitzman', 'Affiliation': 'Center for Research and Education, Benjamin Rose Institute on Aging, Cleveland, Ohio, USA.'}, {'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'Carnie', 'Affiliation': ""Center for Patients and Families, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Pardee RAND Graduate School, Santa Monica, California, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Unger', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Currie', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Lenoir', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Aval-NaʼRee S', 'Initials': 'AS', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.'}, {'ForeName': 'Sitara', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': 'Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Samper-Ternent', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Mukaila', 'Initials': 'M', 'LastName': 'Raji', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Roxana M', 'Initials': 'RM', 'LastName': 'Hirst', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Galloway', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Glen R', 'Initials': 'GR', 'LastName': 'Finney', 'Affiliation': 'Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Ilene', 'Initials': 'I', 'LastName': 'Ladd', 'Affiliation': 'Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Alanna Kulchak', 'Initials': 'AK', 'LastName': 'Rahm', 'Affiliation': 'Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Borek', 'Affiliation': 'Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16862']
2006,32948554,Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.,"INTRODUCTION


Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
METHODS AND ANALYSIS


The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2  test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.
ETHICS AND DISSEMINATION


The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03787732.",2020,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","['13 academic intensive care units in the USA', 'patients receiving positive pressure ventilation during tracheal intubation', '1065 critically ill adults undergoing tracheal intubation with planned use of', 'critically ill adults']","['intravenous fluid bolus', 'fluid REsuscitation', 'positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus', 'fluid REsuscitation during Induction and Intubation']","['cardiovascular collapse', '28-day in-hospital mortality', 'cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",1065.0,0.64588,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036671']
2007,32948579,"Correction: Efficacy of  Bifidobacterium animalis  subsp. lactis (BB-12), B.  infantis  and  Lactobacillus acidophilus  (La-5) probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study Protocol.",,2020,,['preterm infants of 28+0-32+6 weeks of gestation'],"['placebo', 'Bifidobacterium animalis  subsp']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",[],,0.392847,,[],BMJ open,['10.1136/bmjopen-2019-032617corr1']
2008,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2009,32949957,The long-term outcomes of tobacco control strategies based on the cognitive intervention for smoking cessation in COPD patients.,"OBJECTIVE


To evaluate the long-term efficacy of tobacco control strategies based on cognitive intervention for smoking cessation in chronic obstructive pulmonary disease (COPD) patients, and to provide basis for clinical practice.
MATERIALS AND METHODS


102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study. These smokers were randomly divided into intervention group and control group. The intervention group received a cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc. The prevalence of quitting smoking, acute exacerbation (AE), lung function and survival were compared in the groups in 10 years.
RESULTS


There were significant differences between the intervention group and the control group in the rate of persistent quitting smoking in half a year (17.6% vs 3.9%) (P < 0.05), the rate of quitting smoking at the 6th month (58.8% vs 33.3%) (P < 0.05). After 3 months (P < 0.01) and 6 months (P < 0.01), the difference in body weight between the intervention group and the control group was statistically significant. Intervention-group patients had fewer AE per year (P < 0.01) and higher FEV1/FVC ratio (P < 0.01) after 5-year and 10-year follow-up. Besides, the FEV1% predicted in the intervention patients was higher than that in control group after 10-year follow-up. The ages of patients in the death group were greater than those in the survival group. Death-group patients had longer smoking times, higher smoking index, and later onset of COPD symptoms. Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P < 0.01). During 10-year follow-up, 30 patient deaths were recorded (the control group: n = 48; 19 deaths, and intervention group: n = 46; 11 deaths), and patients in the control group had lower survival than those in the intervention group. (P < 0.05).
CONCLUSION


The method of quitting smoking based on cognitive intervention is an effective way for COPD patients to quit smoking successfully. Quitting smoking can slower deterioration in lung function and improve the survival of COPD patients.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000031239 (Chinese clinical trial registry).",2020,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"['102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study', 'COPD patients', 'chronic obstructive pulmonary disease (COPD) patients']","['tobacco control strategies', 'cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc', 'quitting smoking based on cognitive intervention', 'cognitive intervention']","['prevalence of quitting smoking, acute exacerbation (AE), lung function and survival', 'longer smoking times, higher smoking index, and later onset of COPD symptoms', 'higher FEV1/FVC ratio', 'body weight', 'rate of quitting smoking', 'rate of persistent quitting smoking', 'lower survival', 'FEV1/FVC ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",102.0,0.0291403,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: leisi0831@csu.edu.cn.'}, {'ForeName': 'Meilei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 593194666@qq.com.'}, {'ForeName': 'Wenbing', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 837216794@qq.com.'}, {'ForeName': 'Caiqin', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 1974546139@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: pingchen0731@csu.edu.cn.'}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: wushangjie@csu.edu.cn.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106155']
2010,32950853,Supporting coordination of children with ASD using neurological music therapy: A pilot randomized control trial comparing an elastic touch-display with tambourines.,"AIM


To evaluate the efficacy of Neurologic Music Therapy (NMT) using a traditional and a technological intervention (elastic touch-display) in improving the coordination of children with Autism Spectrum Disorder (ASD), as a primary outcome, and the timing and strength control of their movements as secondary outcomes.
METHODS


Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention. Participants were randomly assigned to either use an elastic touch-display (experimental group) or tambourines (control group). We conducted pre- and post- assessment evaluations, including the Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements.
OUTCOMES AND RESULTS


All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention. Participants who used the elastic touch-display scored higher on the DCDQ.
CONCLUSIONS AND IMPLICATIONS


NMT is an efficacious treatment to improve the coordination skills of children with ASD. Elastic touch-displays provide more benefits than the use of tambourines.",2020,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","['children with Autism Spectrum Disorder (ASD', 'children with ASD', 'Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention', 'Participants who used the elastic touch-display scored higher on the DCDQ']","['Neurologic Music Therapy (NMT', 'elastic touch-display (experimental group) or tambourines (control group', 'technological intervention (elastic touch-display', 'neurological music therapy', 'elastic touch-display with tambourines']",['Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",22.0,0.0293978,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","[{'ForeName': 'Franceli L', 'Initials': 'FL', 'LastName': 'Cibrian', 'Affiliation': 'Fowler School of Engineering, Chapman University, Orange California, USA. Electronic address: cibrian@chapman.edu.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Madrigal', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: melisa.madrigal@cetys.edu.mx.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Avelais', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: marina.alvelais@cetys.mx.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tentori', 'Affiliation': 'Computer Science Department, Center for Scientific Research and Higher Education of Ensenada (CICESE), Mexico. Electronic address: mtentori@cicese.mx.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103741']
2011,32950885,First night effect on polysomnographic sleep bruxism diagnosis varies among young subjects with different degrees of rhythmic masticatory muscle activity.,"OBJECTIVE


This study investigated the first night effect on the polysomnographic diagnosis of sleep bruxism (SB).
METHODS


Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7 ± 0.32 years [range: 20.0-33.0]). Sleep variables and rhythmic masticatory muscle activity (RMMA) were scored for two nights. The diagnosis of SB was graded by the frequency of RMMA with cut-off values of two and four times per hour of sleep.
RESULTS


Participants were classified into control (n = 15), low (n = 13) and moderate-high (n = 15) groups. Among the three groups, the concordance of the SB diagnosis was compared between the two nights. Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals. The frequency of RMMA significantly increased from the first to the second night in the moderate-high SB group only. The concordance rate of the severity between the two nights was 93.3% (14/15) in the control group, 76.9% (10/13) in the low SB group and 60% (9/15) in the moderate-high SB group. When the severity was determined on the first night, it remained the same on the second night in 77.8% (14/18) of the control group, 66.7% (10/15) of the low SB group and 90.0% (9/10) of the moderate-high SB group.
CONCLUSION


The results showed that the first night effect on the occurrence of RMMA differed among the different degrees of the RMMA frequency, and suggest that, due to the first night effect, single-night polysomnography may underestimate the moderate-high level of SB but differentiate the low level of SB from controls.",2020,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","['Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7\xa0±\xa00.32 years [range: 20.0-33.0', 'young subjects with different degrees of rhythmic masticatory muscle activity', 'Participants were classified into control (n\xa0=\xa015), low (n\xa0=\xa013) and moderate-high (n\xa0=\xa015) groups']",[],"['concordance of the SB diagnosis', 'sleep efficiency, longer sleep latency and higher frequency of arousals', 'Sleep variables and rhythmic masticatory muscle activity (RMMA', 'occurrence of RMMA', 'frequency of RMMA', 'polysomnographic diagnosis of sleep bruxism (SB', 'concordance rate of the severity']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0114225,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Haraki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tsujisaka', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Toyota', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Oral Rehabilitation, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Osaka University Graduate School of Dentistry, 1-8, Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Health and Counseling Center, Osaka University, 1-17 Machikaneyama-Cho, Toyonaka, Osaka, 560-0043, Japan; Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ishigaki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan. Electronic address: takafumi@dent.osaka-u.ac.jp.'}]",Sleep medicine,['10.1016/j.sleep.2020.08.012']
2012,32950893,Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.,"BACKGROUND


Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
OBJECTIVE


We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability.
METHODS


Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES).
RESULTS


Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy.
CONCLUSION


There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.",2020,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","['patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy', 'Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm', 'pain in multiple sclerosis (MS) patients']","['RELAXaHEAD app with progressive muscle relaxation (PMR', 'RELAXaHEAD', 'Smartphone based behavioral therapy']","['migraine disability and MS pain-related disability', 'recruitment, retention, engagement, and adherence to RELAXaHEAD', 'migraine disability (MIDAS) scores or MS Pain (PES) scores', 'migraine disability (MIDAS) and MS pain (PES', 'Migraine prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",62.0,0.022569,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'NYU Langone Health, Department of Neurology, 222 E 41st, Ninth floor, New York, NY, 10017. Electronic address: mia.minen@nyulangone.org.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Schaubhut', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Morio', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102489']
2013,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND


In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION


The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS


Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS


The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE


The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
2014,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE


To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS


Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS


Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS


The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2015,32959458,Hypersensitivity to Calcitonin Gene-Related Peptide in Post-Traumatic Headache.,"OBJECTIVE


To demonstrate that calcitonin gene-related peptide (CGRP) induces headache exacerbation with migraine-like features in patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI).
METHODS


A randomized, double-blind, placebo-controlled, two-way crossover study was conducted. Analyses were intention-to-treat. Eligible patients were aged 18 to 65 years and had a history of persistent PTH after mild TBI for at least 12 months. Patients were randomized to receive an intravenous infusion of 1.5μg/min of CGRP or placebo (isotonic saline) over 20 minutes on two separate experimental days. A 12-hour observational period was used to evaluate the following outcomes: (1) difference in incidence of headache exacerbation with migraine-like features and (2) difference in area under the curve for headache intensity scores.
RESULTS


Thirty patients (mean age = 37 years, 25 women [83%]) were randomized and completed the study. During the 12-hour observational period, 21 of 30 patients (70%) developed headache exacerbation with migraine-like features after CGRP, compared with 6 patients (20%) after placebo (p < 0.001). The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (p < 0.001).
INTERPRETATION


Patients with persistent PTH are hypersensitive to CGRP, which underscores its pathophysiological importance. Furthermore, CGRP-targeted therapies might provide a novel mechanism-based treatment option for patients with persistent PTH. ANN NEUROL 2020.",2020,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","['Thirty patients (mean age, 37\u2009years; 25 women [83', 'Eligible patients were aged 18 to 65\u2009years and had a history of persistent PTH after mild TBI for at least 12\u2009months', 'patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI', 'patients with persistent PTH']","['placebo', 'Calcitonin Gene-Related Peptide', 'calcitonin gene-related peptide (CGRP', 'intravenous infusion 1.5\u2009μg/min of CGRP or placebo (isotonic saline']","['headache intensity scores', 'headache exacerbation with migraine-like features, 2) difference in area under the curve for headache intensity scores', 'headache exacerbation with migraine-like features']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.678888,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Haidar M', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik W', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Annals of neurology,['10.1002/ana.25915']
2016,32964918,"Double-blind, randomized, placebo-controlled trial with N-acetylcysteine for treatment of severe acute respiratory syndrome caused by COVID-19.","BACKGROUND


A local increase in angiotensin 2 after inactivation of angiotensin-converting enzyme 2 by SARS-CoV-2 may induce a redox imbalance in alveolar epithelium cells, causing apoptosis, increased inflammation and, consequently, impaired gas exchange. We hypothesized that N-acetylcysteine (NAC) administration could restore this redox homeostasis and suppress unfavorable evolution in Covid-19 patients.
OBJECTIVE


To determine whether NAC in high doses can avoid respiratory failure in patients with Covid-19.
METHODS


It was a double-blind, randomized, placebo-controlled, unicentric trial, conducted at the Emergency Department of Hospital das Clínicas, São Paulo, Brazil. We enrolled 135 patients with severe Covid-19 (confirmed or suspected), with an oxyhemoglobin saturation of less than 94% or respiratory rate higher than 24 breaths/min. Patients were randomized to receive NAC 21 g (approximately 300 mg/kg) for 20 hours, or dextrose 5%. Primary endpoint was the need for mechanical ventilation. Secondary endpoints were time of mechanical ventilation, admission to ICU, time in ICU, and mortality.
RESULTS


Baseline characteristics were very similar in the two groups, with no significant difference in age, sex, comorbidities, medicines taken, and disease severity. Also, groups were similar in laboratory tests and chest CT scan findings. Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675). No difference was observed in secondary endpoints.
CONCLUSION


Administration of NAC in high doses did not affect the evolution of severe Covid-19.",2020,"Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675).","['severe acute respiratory syndrome caused by COVID-19', 'patients with Covid-19', '135 patients with severe Covid-19 (confirmed or suspected), with an oxyhemoglobin saturation of less than 94% or respiratory rate higher than 24 breaths/min', 'Emergency Department of Hospital das Clínicas, São Paulo, Brazil']","['endotracheal intubation and mechanical ventilation', 'placebo', 'NAC', 'N-acetylcysteine', 'Placebo', 'N-acetylcysteine (NAC']","['time of mechanical ventilation, admission to ICU, time in ICU, and mortality', 'evolution of severe Covid-19', 'need for mechanical ventilation']","[{'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",135.0,0.686173,"Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675).","[{'ForeName': 'Julio Cesar Garcia', 'Initials': 'JCG', 'LastName': 'de Alencar', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Claudia de Lucena', 'Initials': 'CL', 'LastName': 'Moreira', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alicia Dudy', 'Initials': 'AD', 'LastName': 'Müller', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cleuber Esteves', 'Initials': 'CE', 'LastName': 'Chaves', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marina Akemi', 'Initials': 'MA', 'LastName': 'Fukuhara', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elizabeth Aparecida', 'Initials': 'EA', 'LastName': 'da Silva', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria de Fátima Silva', 'Initials': 'MFS', 'LastName': 'Miyamoto', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanusa Barbosa', 'Initials': 'VB', 'LastName': 'Pinto', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cauê Gasparotto', 'Initials': 'CG', 'LastName': 'Bueno', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felippe', 'Initials': 'F', 'LastName': 'Lazar', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luz Marina', 'Initials': 'LM', 'LastName': 'Gomez', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Clara Saad', 'Initials': 'MCS', 'LastName': 'Menezes', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julio Flavio Meirelles', 'Initials': 'JFM', 'LastName': 'Marchini', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas Oliveira', 'Initials': 'LO', 'LastName': 'Marino', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Antônio', 'Initials': 'RA', 'LastName': 'Brandão', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Heraldo Possolo', 'Initials': 'HP', 'LastName': 'Souza', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1443']
2017,32960673,A preoperative radiomics model for the identification of lymph node metastasis in patients with early-stage cervical squamous cell carcinoma.,"OBJECTIVES


To develop and validate a radiomics model for preoperative identification of lymph node metastasis (LNM) in patients with early-stage cervical squamous cell carcinoma (CSCC).
METHODS


Total of 190 eligible patients were randomly divided into training ( n  = 100) and validation ( n  = 90) cohorts. Handcrafted features and deep-learning features were extracted from T2W fat suppression images. The minimum redundancy maximum relevance algorithm and LASSO regression with 10-fold cross-validation were used for key features selection. A radiomics model that incorporated the handcrafted-signature, deep-signature, and squamous cell carcinoma antigen (SCC-Ag) levels was developed by logistic regression. The model performance was assessed and validated with respect to its calibration, discrimination, and clinical usefulness.
RESULTS


Three handcrafted features and three deep-learning features were selected and used to build handcrafted- and deep-signature. The model, which incorporated the handcrafted-signature, deep-signature, and SCC-Ag, showed satisfactory calibration and discrimination in the training cohort (AUC: 0.852, 95% CI: 0.761-0.943) and the validation cohort (AUC: 0.815, 95% CI: 0.711-0.919). Decision curve analysis indicated the clinical usefulness of the radiomics model. The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training and validation cohorts.
CONCLUSION


The presented radiomics model can be used for preoperative identification of LNM in patients with early-stage CSCC. Its performance outperforms that of SCC-Ag level analysis alone.
ADVANCES IN KNOWLEDGE


A radiomics model incorporated radiomics signature and SCC-Ag levels demonstrated good performance in identifying LNM in patients with early-stage CSCC.",2020,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","['patients with Early-stage cervical squamous cell carcinoma', 'Total of 190 eligible patients were randomly divided intotraining( n  = 100) andvalidation ( n  = 90) cohorts', 'patients with early-stage cervical squamous cell carcinoma (CSCC']",[],"['handcrafted-signature, deep-signature and squamous cell carcinoma antigen (SCC-Ag) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0279671', 'cui_str': 'Squamous cell carcinoma of cervix'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0075091', 'cui_str': 'Squamous cell carcinoma antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",190.0,0.027531,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","[{'ForeName': 'Lifen', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Huasheng', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Ruichun', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': ""Department of anesthesiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Zaiyi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}]",The British journal of radiology,['10.1259/bjr.20200358']
2018,32961568,Evaluation of Efficacy of Coenzyme Q10 as an Adjunct to Nonsurgical Periodontal Therapy and Its Effect on Crevicular Superoxide Dismutase in Patients with Chronic Periodontitis.,"OBJECTIVES


To assess the efficacy of coenzyme Q10 (CoQ10) as an adjunct to nonsurgical periodontal therapy and its effect on superoxide dismutase (SOD) in gingival crevicular fluid (GCF) in patients with chronic periodontitis (CP).
MATERIALS AND METHODS


A total of 16 patients aged between 30 and 50 years having mild to moderate CP of both sexes having pocket depth of 5 to 7 mm in four nonadjacent interproximal sites were selected. The sites were randomized and divided into treatment and control groups. CoQ10 and a placebo gel were administered in the treatment and control sites, respectively, at baseline after scaling and root planing (SRP). GCF was collected using microcapillary method at baseline and 3 months and was assessed for SOD using enzyme-linked immunosorbent assay reader at 450 nm wavelength. Probing pocket depth, gingival index, and plaque index were assessed at baseline, 1 month, and 3 months, respectively.
STATISTICAL ANALYSIS


For each assessment point, data were statistically analyzed using Student's  t -test and paired  t -test. Level of significance was set at  p  < 0.05.
RESULTS


On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
CONCLUSIONS


Adjunctive use of CoQ10 with SRP can boost the antioxidant concentration, but it is not superior to SRP in the treatment of CP.",2020,"On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
","['Patients with Chronic Periodontitis', 'patients with chronic periodontitis (CP', '16 patients aged between 30 and 50 years having mild to moderate CP of both sexes having pocket depth of 5 to 7 mm in four nonadjacent interproximal sites were selected']","['placebo gel', 'Coenzyme Q10', 'CoQ10 with SRP', 'coenzyme Q10 (CoQ10']","['superoxide dismutase (SOD', 'Probing pocket depth, gingival index, and plaque index', 'Crevicular Superoxide Dismutase', 'level of SOD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0280619,"On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
","[{'ForeName': 'Swagat', 'Initials': 'S', 'LastName': 'Pranam', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Palwankar', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}]",European journal of dentistry,['10.1055/s-0040-1716596']
2019,32955601,Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery.,"BACKGROUND


In recent years, promising results were achieved with the use of ultrasound (US)-guided interfascial plane blocks for effective postoperative analgesia in several surgeries. Erector spina plane (ESP) block and mid-transverse to pleura plane (MTP) block are the latest techniques in this area. The aim of this prospective and randomized study was to compare the postoperative analgesic efficacy of bilateral ESP and MTP blocks in patients undergoing lumbar spinal surgery under general anesthesia (GA).
METHODS


A total of 120 adult patients were included in the study and randomized into 3 groups: group ESP (n = 40), group MTP (n = 40) and group Control (n = 40). The patients in the group ESP received a bilateral block by injecting 20 ml of 0.25% bupivacaine at a vertebrae level in the mid-point of the incision before GA. The same LA was administrated bilaterally at the T12/L1 level in the group MTP. Postoperatively, a multimodal analgesic regimen including an intravenous tramadol patient-controlled analgesia (PCA), paracetamol and dexketoprofen was used in all groups. Postoperative pain was assessed using a visual analogue scale (VAS) during the first 48 postoperative hours. Pethidine was used as a rescue analgesic when VAS score was >3. Primary outcome measure was mean pain scores. Secondary outcome measures were consumption of rescue analgesic and the amount of tramadol delivered by PCA. A p < 0.05 was considered statistically significant.
RESULTS


Mean VAS scores were significantly higher in the group Control than in the group MTP and group ESP at all-time points during 48 h (Control > MTP > ESP; p < 0.001). Mean VAS scores were lower in group ESP than group MTP in postoperative 12 h (p < 0.001). Rescue analgesic consumption, number of bolus demand on PCA, PCA bolus demand dose, total PCA dose, and complications related to opioid consumption were highest in control group and lowest in ESP group (Control > MTP > ESP; p < 0.001).
CONCLUSION


Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.",2020,Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.,"['patients undergoing lumbar spinal surgery under general anesthesia (GA', 'A\xa0total of 120 adult patients', 'lumbar spinal surgery']","['ultrasound (US)-guided interfascial plane blocks', 'bilateral block by injecting 20\u202fml of 0.25% bupivacaine', 'Pethidine', 'tramadol patient-controlled analgesia (PCA), paracetamol and dexketoprofen', 'Ultrasound-guided erector spinae block versus mid-transverse process to pleura block', 'ESP', 'ESP and MTP blocks', 'bilateral ESP and MTP blocks']","['postoperative analgesic efficacy', 'mean pain scores', 'visual analogue scale (VAS', 'effective pain relief', 'Mean VAS scores', 'Rescue analgesic consumption, number of bolus demand on PCA, PCA bolus demand dose, total PCA dose, and complications related to opioid consumption', 'Erector spina plane (ESP) block and mid-transverse to pleura plane (MTP) block', 'Postoperative pain', 'consumption of rescue analgesic and the amount of tramadol delivered by PCA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",120.0,0.0622543,Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.,"[{'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Eskin', 'Affiliation': 'Gülhane Medical School, University of Medical Science, Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ceylan', 'Affiliation': 'Gülhane Medical School, University of Medical Science, Ankara, Turkey.'}, {'ForeName': 'M Ö', 'Initials': 'MÖ', 'LastName': 'Özhan', 'Affiliation': 'Özel Çankaya Hospital, Ankara, Turkey. metozhan2003@yahoo.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Atik', 'Affiliation': 'Balıkesir University Medical School, Balıkesir, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00848-w']
2020,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
2021,32956890,"Ultrasound-Guided Erector Spinae Plane Block versus Modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study.","OBJECTIVE


This study aimed to compare the ultrasound (US)-guided erector spinae plane block (ESPB) and modified-thoracolumbar interfascial plane (mTLIP) block for postoperative pain management in lumbar discectomy surgery patients.
METHODS


A total of 90 patients scheduled for lumbar discectomy were randomly assigned into 3 groups (n = 30 per group): an ESPB group, an mTLIP group, and a control group. In the ESPB and mTLIP groups, a single-shot US-guided block was administered with 20 mL of 0.25% bupivacaine bilaterally. All patients received intravenous patient-controlled postoperative analgesia with fentanyl, and 1 g intravenous paracetamol every 6 hours. Fentanyl consumption, Visual Analog Scale (VAS) pain scores, rescue analgesia, block procedure time, and side-effects were evaluated.
RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared with the control group (P < 0.05). No significant difference was observed concerning intra- and postoperative opioid consumption between the ESPB and the mTLIP group (P < 0.001). Passive VAS score at the postanesthesia care unit, second, fourth, and eighth hours, and active VAS score at the postanesthesia care unit, second, fourth, eighth, and 16th hours were significantly lower in the ESPB and mTLIP groups compared with the control group (P < 0.05). The use of rescue analgesia was significantly lower in the ESPB and mTLIP groups than in the control group (9/30, 7/30, and 21/30, respectively, P < 0.001). The block procedure time was similar between groups (P = 0.198).
CONCLUSIONS


US-guided ESPB and mTLIP block may provide adequate pain control after discectomy surgery. However, there is a nonsuperiority between ESPB and the mTLIP groups.",2020,"RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared to the control group (p<0.05).","['lumbar discectomy surgery patients', '90 patients scheduled for lumbar discectomy', 'Lumbar Discectomy Surgery']","['bupivacaine', 'mTLIP', 'ESPB', 'intravenous patient-controlled postoperative analgesia with fentanyl, one g intravenous paracetamol', 'ultrasound (US)-guided erector spinae plane block (ESPB) and modified-thoracolumbar interfascial plane (mTLIP) block', 'Ultrasound-Guided Erector Spinae Plane Block vs. modified-Thoracolumbar Interfascial Plane Block']","['intraoperative and postoperative opioid consumption', 'Postoperative opioid consumption', 'rescue analgesia', 'block procedure time', 'Fentanyl consumption, visual analog pain scores (VAS), rescue analgesia, block procedure time, and side-effects']","[{'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.0508988,"RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared to the control group (p<0.05).","[{'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Medipol University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mürsel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Medipol University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ahmet Murat', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey. Electronic address: aliahiskalioglu@hotmail.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.09.077']
2022,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2023,32959370,A Pilot Randomized Controlled Trial of a Nutrition and Dietary Intervention for Early Care and Education Providers.,"BACKGROUND


The aim of this study is to evaluate the feasibility and preliminary impact of the Create Healthy Futures program, a self-paced, 6-lesson, web-based intervention on promoting healthy eating for Early Care and Education (ECE) providers, using a group-randomized controlled trial design with 3 repeated measurements.
METHODS


Nine ECE facilities in Ohio were recruited and randomly assigned to intervention (N = 4) and comparison (N = 5). The 111 participants are mostly female (97.3%), college graduated (59.5%), and overweight or obese (75.2%). Nutrition-related psychosocial and environmental factors and individual behaviors were assessed at baseline, post-test, and 3-month follow-up. We used mixed model analyses to compare changes between time points, controlling for ethnicity, age, and center effect, and calculated effect size to assess the magnitude of change.
RESULTS


We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes. The study demonstrated high feasibility with 94.1% enrollment rate, 87.5% intervention completion rate, and 83.8% retention rate.
CONCLUSIONS


This pilot study demonstrated high feasibility and acceptability of nutrition intervention programs using an online platform among ECE providers.",2020,"We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes.","['healthy eating for Early Care and Education (ECE) providers', 'Nine ECE facilities in Ohio were recruited and randomly assigned to intervention', 'Early Care and Education Providers', '111 participants are mostly female (97.3%), college graduated (59.5%), and overweight or obese (75.2']","['Nutrition and Dietary Intervention', 'nutrition intervention programs']","['nutrition knowledge', 'perceived support for staff wellness', 'reducing perceived barriers to eating fruits and vegetables']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",111.0,0.103981,"We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes.","[{'ForeName': 'Ru-Jye', 'Initials': 'RJ', 'LastName': 'Chuang', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, 1200 Pressler Street, RAS E615, Houston, TX, 77030, USA.'}, {'ForeName': 'Jill N', 'Initials': 'JN', 'LastName': 'Cox', 'Affiliation': 'Penn State Extension Better Kid Care, 2182 Sandy Drive, Suite 204, State College, PA, 16803, USA.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Mincemoyer', 'Affiliation': 'Penn State University, 2182 Sandy Drive, Suite 204, State College, PA, 16803, USA.'}, {'ForeName': 'Shreela V', 'Initials': 'SV', 'LastName': 'Sharma', 'Affiliation': '>Department of Epidemiology, Human Genetics and Environmental Sciences, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, 1200 Pressler Street, RAS E643, Houston, TX, 77030, USA.'}]",The Journal of school health,['10.1111/josh.12951']
2024,32965075,"Efficacy and safety of polyethylene glycol loxenatide monotherapy in type 2 diabetes patients: A multicentre, randomized, double-blind, placebo-controlled phase 3a clinical trial.","AIM


To evaluate the efficacy and safety of polyethylene glycol loxenatide (PEX168) monotherapy in type 2 diabetes (T2D) patients in China.
MATERIALS AND METHODS


In a multicentred, randomized, double-blinded, placebo-controlled phase 3a clinical trial, 361 patients with inadequate glycaemic control (HbA1c 7.0%-10.5%, fasting plasma glucose <13.9 mmol/L) were randomized (1:1:1) for weekly subcutaneous injections: placebo, PEX168/100 μg or PEX168/200 μg. The 24-week treatment was followed by a 28-week extension, during which placebo-treated patients were randomly assigned to PEX168/100 μg or PEX168/200 μg. The primary efficacy endpoint was the HbA1c change from baseline to week 24.
RESULTS


The three groups had similar demographics and baseline characteristics. The HbA1c least-square mean (95% CI) change from baseline to week 24 was greater for PEX168/100 μg (-1.02% [-1.21%, -0.83%]) and PEX168/200 μg (-1.34% [-1.54%, -1.15%]) than for placebo (-0.17% [-0.36%, 0.02%]); (superiority: P < .0001). The proportions of patients with less than 7% HbA1c in the placebo, PEX168/100 μg and PEX168/200 μg groups were 15.7%, 34.7% and 46.6%, respectively. Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0% and 0% for PEX168/100 μg, PEX168/200 μg and placebo, respectively) and vomiting (2.4%, 8.3% and 0% for PEX168/100 μg, PEX168/200 μg and placebo, respectively). Six (1.6%) patients (PEX168/100 μg: N = 2 [1.6%], PEX168/200 μg: N = 3 [2.5%] and placebo: N = 1 [0.8%]) discontinued treatment because of AEs. Four (1.2%) patients (PEX168/100 μg: N = 3 [2.5%] and PEX168/200 μg: N = 1 [0.9%]) developed PEX168 antidrug antibodies.
CONCLUSION


PEX168 monotherapy significantly improved glycaemic control in T2D patients with a safety profile resembling that of other glucagon-like peptide-1 receptor agonists.",2020,"Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively) and vomiting (2.4%, 8.3%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively).","['361 patients with inadequate glycemic control (HbA1c, 7.0-10.5%; fasting plasma glucose, <13.9\u2009mmol/L', 'μg', 'type 2 diabetes (T2DM) patients in China', '2 diabetes patients']","['subcutaneous injections: placebo, PEX168/100\u2009μg, or PEX168/200\u2009μg', 'PEX168 monotherapy', 'polyethylene glycol loxenatide (PEX168', 'placebo-treated patients were randomly assigned to PEX168/100\u2009μg or PEX168/200\u2009μg', 'placebo', 'monotherapy']","['efficacy and safety', 'nausea', 'Efficacy and safety', 'vomiting', 'HbA1c change', 'glycemic control', 'HbA1c least-square mean [LSM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079755', 'cui_str': 'PEX168'}, {'cui': 'C4077947', 'cui_str': 'polyethylene glycol loxenatide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",361.0,0.663396,"Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively) and vomiting (2.4%, 8.3%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shuai', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The Center of Clinical Research of Endocrinology and Metabolic Diseases in Chongqing and Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Daoxiong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, People's Hospital of Hainan, Haikou, China.""}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Central Hospital of Minhang District, Minhang Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Hainan Medical University, Haikou, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology Medicine, Lianyungang First People's Hospital, Affiliated Hospital of Xuzhou Medical College, Lianyungang, China.""}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14198']
2025,32965691,"Effects of different mean arterial pressure targets on plasma volume, ANP and glycocalyx-A randomized trial.","BACKGROUND


Arterial haematocrit (Hct) has been shown to decrease after anaesthesia induction, most probably because of an increased plasma volume (PV). The primary objective was to quantify change in PV if mean arterial pressure (MAP) was kept at baseline level or allowed to decrease to 60 mm Hg. Our secondary objective was to evaluate underlying mechanisms of this response.
METHODS


Twenty-four coronary artery bypass patients were randomized to a higher (90 mm Hg, intervention group) or lower (60 mm Hg, control group) MAP by titration of norepinephrine. During the experimental procedure, no fluids were administered. Baseline PV was measured by  125  I-albumin and the change in PV was calculated from the change in Hct. Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components were measured from baseline to 50 minutes after anaesthesia induction.
RESULTS


The MAP during the trial was 93 ± 9 mm Hg in the intervention group and 62 ± 5 mm Hg in the control group. PV increased with up to 420 ± 180 mL in the control group and 45 ± 130 mL in the intervention group (P < .001). Albumin and colloid osmotic pressure decreased significantly more in the control group. MR-proANP increased in the control group but no shedding of the glycocalyx layer was detected in either of the groups.
CONCLUSION


Allowing mean arterial pressure to fall to 60 mm Hg during anaesthesia induction, increases the plasma volume due to reabsorption of interstitial water, with no ANP-induced degradation of the endothelial glycocalyx.",2020,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,['Twenty-four coronary artery bypass patients'],['norepinephrine'],"['Albumin and colloid osmotic pressure', 'Baseline PV', 'glycocalyx layer', 'PV', 'plasma volume (PV', 'PV if mean arterial pressure (MAP', 'MR-proANP', 'Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0029393', 'cui_str': 'Osmotic pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",24.0,0.08616,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,"[{'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Damén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Forssell-Aronsson', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hesse', 'Affiliation': 'Department of Laboratory Medicine, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentzer', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg and Lund University, Helsingborg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nygren', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13710']
2026,32963063,Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.,"INTRODUCTION


Through addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.
METHODS AND ANALYSIS


Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.
DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
ETHICS AND DISSEMINATION


The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.
TRAIL REGISTRATION NUMBER


This trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.",2020,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","['Australian primary care patients', 'Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey']",[],['uptake of LARC'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],,0.172989,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia Danielle.Mazza@monash.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Amos', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Watson', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Centre for Health Economics Research & Evaluation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics & Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Lucke', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McNamee', 'Affiliation': 'Family Planning Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Royal Prince Alfred Hospital, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035895']
2027,32963066,Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol.,"INTRODUCTION


Over 52 million children under 5 years of age become wasted each year, but only 17% of these children receive treatment. Novel methods to identify and deliver treatment to malnourished children are necessary to achieve the sustainable development goals target for child health. Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.
METHODS AND ANALYSIS


This randomised controlled trial will recruit 1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. Caregiver-infant dyads will be randomised to either a maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC). Study staff will train all caregivers to measure their child's mid-upper arm circumference (MUAC). Caregivers in the MAMMS arm will be given two colour coded and graduated insertion MUAC tapes and be enrolled in a mHealth system that sends weekly short message service (SMS) messages prompting caregivers to measure and report their child's MUAC by SMS. Caregivers in the SOC arm will receive routine monitoring by community health volunteers coupled with a quarterly visit from study staff to ensure adequate screening coverage. The primary outcome is identification of childhood malnutrition, defined as MUAC <12.5 cm, in the MAMMS arm compared with the SOC arm. Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age. Finally, we will explore the acceptability, fidelity and feasibility of implementing the MAMMS within existing nutrition programmes.
ETHICS AND DISSEMINATION


The study was approved by review boards at the University of Washington and the Kenya Medical Research Institute. A data and safety monitoring board has been convened, and the results of the trial will be published in peer-reviewed scientific journals, presented at appropriate conferences and to key stakeholders.
TRIAL REGISTRATION NUMBER


NCT03967015; Pre-results.",2020,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"['1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya', 'malnourished children', 'Kenya']","['MAMMS', 'maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC', 'two-way short message service (SMS', 'Mobile health (mHealth) programmes']","['accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition', 'identification of childhood malnutrition']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",1200.0,0.129427,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"[{'ForeName': 'Kirkby D', 'Initials': 'KD', 'LastName': 'Tickell', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA kirkbt@uw.edu.'}, {'ForeName': 'Mareme M', 'Initials': 'MM', 'LastName': 'Diakhate', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Goodman', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Rubin Means', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Choo', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Achieng', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Masheti', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Benson O', 'Initials': 'BO', 'LastName': 'Singa', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'McGrath', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036660']
2028,32955013,The efficacy of a patient decision aid for improving person-centered decision-making in older adults with obstructive sleep apnea.,"STUDY OBJECTIVES


Person-centered obstructive sleep apnea (OSA) care is a collaborative approach that is respectful of an individual's health priorities. Informed decision-making is essential to person-centered care, especially as patients age. In a feasibility study, we evaluated the effects of a new decision aid (Decide2Rest) on OSA treatment decision-making in older adults.
METHODS


Patients (aged ≥ 60 years) with newly diagnosed OSA were recruited from two healthcare systems and randomized to either Decide2Rest or a control program. Post-intervention outcomes included 1) Decisional Conflict Scale (DCS; 0-100 where 0=low and 100=high conflict), which measures perceptions of uncertainty, whether decisions reflect what matters most to patients and whether patients feel supported in decision making, 2) Preparation for Decision Making scale (PDM; 0-100 where 0=least and 100 most prepared), and OSA knowledge (0-100 where 0=poor and 100 outstanding). Multivariable linear regression models examined relationships between Decide2Rest and outcomes (DCS, PDM, OSA knowledge).
RESULTS


73 patients were randomized to Decide2Rest (N=36; mean age 69 years; 72% male) versus control (N= 37; mean age 69 years; 70% male). Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
CONCLUSIONS


The Decide2Rest program promotes person-centered OSA decision-making for older patients with newly diagnosed OSA. Future studies are needed to optimize implementation of the program.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, Title: Improving Older Adults' Decision Making for OSAT (eDecide2Rest), Identifier: NCT03138993, URL: https://clinicaltrials.gov/ct2/show/NCT03138993.",2020,"Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
","['older adults', '73 patients were randomized to Decide2Rest (N=36; mean age 69 years; 72% male) versus control (N= 37; mean age 69 years; 70% male', 'Person-centered obstructive sleep apnea (OSA) care', 'Patients (aged ≥ 60 years) with newly diagnosed OSA', 'older adults with obstructive sleep apnea', 'older patients with newly diagnosed OSA']","['new decision aid (Decide2Rest', 'Decide2Rest or a control program']","['Decide2Rest and outcomes (DCS, PDM, OSA knowledge', 'OSA knowledge', 'Decisional Conflict Scale', 'decisional conflict']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",73.0,0.0442605,"Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
","[{'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Liang', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Ron D', 'Initials': 'RD', 'LastName': 'Hays', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nananda', 'Initials': 'N', 'LastName': 'Col', 'Affiliation': 'University of New England, Biddeford, Maine.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Patterson', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Josephson', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Mitchell', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Sanchez', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Aysola', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Yeonsu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Zeidler', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Alessi', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8798']
2029,32955081,"Treatment of COVID-19 Patients with Prolonged Post-Symptomatic Viral Shedding with Leflunomide -- a Single-Center, Randomized, Controlled Clinical Trial.","OBJECTIVE


To evaluate the efficacy and safety of leflunomide, an approved dihydroorotate dehydrogenase inhibitor, to treat COVID-19 patients with prolonged post-symptomatic viral shedding.
METHODS


We conducted a prospective, randomized, controlled, open-label trial involving hospitalized adult COVID-19 patients with prolonged PCR positivity. Patients were randomly assigned to receive either leflunomide (50 mg, q12h, three consecutive times, orally; then 20 mg, once daily for 8 days), in addition to nebulized interferon alpha 2a (IFN α-2a, 3 million IU each time, twice daily for 10 days), or nebulized IFN α-2a alone for 10 days. The primary end point was the duration of viral shedding.
RESULTS


A total of 50 COVID-19 patients with prolonged PCR positivity were randomized into 2 groups; 26 were assigned to the leflunomide group, and 24 were assigned to the interferon alone group. Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186). In addition, the patients given leflunomide did not have a substantially shorter length of hospital stay than patients treated with interferon alone, with median (IQRs) durations of 29.0 (19.3-47.3) days and 33.0 (29.3-42.8) days, respectively, P=0.170. Two leflunomide recipients were unable to complete the full 10-day course of administration due to adverse events.
CONCLUSIONS


In COVID-19 patients with prolonged PCR positivity, no benefit in terms of the duration of viral shedding was observed with the combined treatment of leflunomide and IFN α-2a beyond IFN α-2a alone.",2020,"Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186).","['50 COVID-19 patients with prolonged PCR positivity', 'hospitalized adult COVID-19 patients with prolonged PCR positivity', 'COVID-19 patients with prolonged post-symptomatic viral shedding', 'COVID-19 Patients with Prolonged Post-Symptomatic Viral Shedding with Leflunomide -- a Single-Center']","['interferon', 'interferon alone', 'nebulized IFN α-2a alone', 'leflunomide']","['shorter length of hospital stay', 'duration of viral shedding']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}]",50.0,0.207998,"Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186).","[{'ForeName': 'Mengmei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Xiaochen', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Shaolin', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Zhenlian', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1417']
2030,32950613,A 4-week exercise and protein program improves muscle mass and physical functioning in older adults - A pilot study.,"BACKGROUND


Prehabilitation might attenuate common surgery-induced losses in muscle mass and physical performance. Beneficial effects of physical exercise with protein supplementation have been reported in older adults, but typically after an intervention of at least 12 weeks. The time-window for pre-surgery training is often limited to around 30 days, and it is not known if it is possible to achieve comparable results in such a short time window.
OBJECTIVES


The aim of this study was to pilot-test the effectiveness of a controlled four-week combined exercise and protein supplementation program on skeletal muscle-related outcomes in a Dutch older adult population.
DESIGN


This study was a one-armed pilot trial.
PARTICIPANTS


Seventeen older men and women, aged 55-75y, not scheduled for surgery.
INTERVENTION


A 4-week intervention program consisting of a twice-weekly supervised resistance and high-intensity aerobic exercise training of 75 min, combined with daily protein supplementation (2 doses of 15.5 g/day at breakfast and lunch).
MEASUREMENT


After two and four weeks, isometric quadriceps maximal voluntary contraction (MVC) was assessed via Biodex and quadriceps cross-sectional area (CSA) via magnetic resonance imaging. Other outcome measures were handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test.
RESULTS


Compliance to the supervised training sessions (99.3%) and the protein supplementation (97%) was very high. The 4-week exercise and protein program led to an increase in quadriceps CSA of 2.3 ± 0.7 cm 2  (P = 0.008) in the dominant leg and 3.2 ± 0.7 cm 2  (P < 0.001) in the non-dominant leg. Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003). Chair rise test time improved with -3.8 ± 0.5 s (P < 0.0001), and VO 2 -max improved with 3.3 ± 1.1 ml/min/kg (P = 0.014). We observed no changes in body weight and handgrip strength.
CONCLUSION


A 4-week exercise and protein intervention led to improvements in muscle-related outcomes in older adults with low levels of physical activity.",2020,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","['older adults', 'Seventeen older men and women, aged 55-75y, not scheduled for surgery', 'older adults with low levels of physical activity', 'Dutch older adult population']","['combined exercise and protein supplementation program', 'exercise and protein intervention', 'exercise and protein program', 'intensity aerobic exercise training of 75\u202fmin, combined with daily protein supplementation', 'physical exercise with protein supplementation']","['muscle mass and physical functioning', 'isometric quadriceps maximal voluntary contraction (MVC', 'Isometric quadriceps MVC', 'Chair rise test time', 'VO 2 -max', 'handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test', 'body weight and handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",17.0,0.0475282,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Grootswagers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands. Electronic address: pol.grootswagers@wur.nl.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Regt', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Jacintha', 'Initials': 'J', 'LastName': 'Domić', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Dronkers', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands; Research group Innovation and Movement Care, University of Applied Science, Utrecht, the Netherlands.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Science Office, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands; Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}]",Experimental gerontology,['10.1016/j.exger.2020.111094']
2031,32950645,Rationale and protocol for translating basic habituation research into family-based childhood obesity treatment: Families becoming healthy together study.,"This publication describes the rationale and protocol, including design, aims, intervention, and measures, of Families Becoming Healthy Together, a randomized clinical trial examining the effect of a limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT) on body mass index (BMI) and habituation rate to RED foods. One hundred fifty-six children (ages: 8-12 y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25 kg/m 2 ), both with overweight or obesity, will be randomized to one of two, interventions: FBT or FBT + Variety. All participants will receive 29 sessions of FBT and be prescribed the Traffic Light Diet (1000-1500 kcal/day, ≤ 2 RED food servings/day), and a physical activity goal (≥ 60 min/day [child] or 150 min/week [adult] of moderate-vigorous physical activity (MVPA)). FBT + Variety will also identify two RED foods, a dinner entrée and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED foods. Measures of anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity will be assessed at 0, 6, 12, and 18-months. This study translates a line of basic behavioral research examining how dietary variety influences habituation into a dietary prescription that will be tested within an efficacy trial. It is hypothesized that a novel, limited dietary variety prescription within FBT should promote a faster food habituation rate, reducing energy intake and amplifying long-term weight loss in children.",2020,One hundred fifty-six children (ages: 8-12,"['family-based childhood obesity treatment', 'One hundred fifty-six children (ages: 8-12', 'y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25\u202fkg/m 2 ), both with overweight or obesity', 'children']","['FBT or FBT\u202f+\u202fVariety', 'FBT and be prescribed the Traffic Light Diet', 'physical activity goal (≥ 60\u202fmin/day [child] or 150\u202fmin/week [adult] of moderate-vigorous physical activity (MVPA', 'limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT']","['anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity', 'body mass index (BMI) and habituation rate to RED foods']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]",156.0,0.050562,One hundred fifty-six children (ages: 8-12,"[{'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Douglas', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Kristoffer S', 'Initials': 'KS', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital/Brown Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA. Electronic address: hraynor@vols.utk.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106153']
2032,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND


The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM


To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS


In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION


The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2033,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE


Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS


Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS


Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS


Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
2034,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
2035,32958483,Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.,"INTRODUCTION


Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.
METHODS AND ANALYSIS


The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle.
ETHICS AND DISSEMINATION


The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language.
TRIAL REGISTRATION NUMBER


NCT03988985.",2020,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"['1074 primary care patients from North, East and South Germany', 'cardiac patients']","['Depression screening using patient-targeted feedback', 'patient-targeted feedback intervention', 'receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback']","['patient engagement in mental healthcare, professional depression care and cost-effectiveness', 'depression severity (PHQ-9']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",1074.0,0.195457,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany s.kohlmann@uke.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Eisele', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lea-Elena', 'Initials': 'LE', 'LastName': 'Braunschneider', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Department of Primary Care, University Medical Centre Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Resmark', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonius', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Department of Primary Care, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allwang', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nikendei', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy for General Internal Medicine and Psychosomatics, University Medical Centre of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Department of Primary Care, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Department of Psychosocial Medicine and Psychotherapy, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035973']
2036,32958487,Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study.,"INTRODUCTION


Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals. Helping people discuss and formalise their preferences in end-of-life care, as planned in the Go Wish intervention, could reduce health-related anxiety in the advance care planning (ACP) and advance directive (AD) process. The aims of this study are (1) to test the effectiveness of the Go Wish intervention among outpatients in early-stage palliative care and (2) to understand the role of defence mechanisms in end-of-life discussions among nurses, patients and relatives.
METHODS AND ANALYSIS


A mixed-methods study will be performed. A cluster randomised controlled trials with three parallel arms will be conducted with 45 patients with chronic progressive diseases impacting life expectancy in each group: (1) Group A, Go Wish intervention for patients and their relatives; (2) Group A, Go Wish intervention for patients alone and (3) Group B, for patients (with a waiting list), who will receive the standardised information on ADs (usual care). Randomisation will be at the nurse level as each patient is referred to one of the 20 participating nurses (convenience sample of 20 nurses). A qualitative study will be conducted to understand the cognitive and emotional processes and experiences of nurses, patients and relatives confronted with end-of-life discussions. The outcome measurements include the completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Human Research Ethics Committee of the Canton of Geneva, Switzerland (no. 2019-00922). The findings will be disseminated to practice (nurses, patients and relatives), to national and international scientific conferences, and peer-reviewed journals covering nursing science, psychology and medicine.
TRIAL REGISTRATION NUMBER


NCT04065685.",2020,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","['outpatients in early-stage palliative care', '45 patients with chronic progressive diseases impacting life expectancy in each group', '20 participating nurses (convenience sample of 20 nurses', 'outpatients in early-stage palliative care and (2']",['Nurse-led patient-centred intervention to increase written advance directives'],"['completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",45.0,0.102533,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Iglesias', 'Affiliation': 'School of Health Sciences (HEdS-FR), HES-SO University of Applied Sciences and Arts Western Switzerland, Friourg, Switzerland katia.iglesias@hefr.ch.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Busnel', 'Affiliation': 'Geneva Institution for Homecare and Assistance (imad), Geneva, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Dufour', 'Affiliation': 'School of Management and Engineering Vaud (HEIG-VD), HES-SO University of Applied Sciences and Arts Western Switzerland, Yverdon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Division of Palliative Medicine, Department of rehabilitation and geriatrics, University Hospitals Geneva, Geneva, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Séchaud', 'Affiliation': 'Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-037144']
2037,31813028,Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials.,"PURPOSE


This study aims to specify and explain the previous findings of unexpectedly high rates of ejaculatory disorders, i.e. 56%, found after prostatic artery embolization (PAE) in a randomized controlled trial comparing safety and efficacy of PAE and transurethral resection of the prostate (TURP).
PATIENTS AND METHODS


Case report forms of the randomized controlled trial were analyzed to specify the grade of postoperative ejaculatory dysfunction 3 months postoperatively. In addition, study participants with assessable ejaculation were asked to complete the four-item Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function at present, as well as before treatment and 3 months after. Potential explanations for ejaculatory disorders after PAE were derived from histological examination of five radical prostatectomy specimens of patients that underwent PAE 6 weeks before radical prostatectomy within a proof-of-concept trial at the study site, St. Gallen Cantonal Hospital. An experienced uropathologist systematically examined the whole-gland embedded tissue with focus on structures that are involved into ejaculation.
RESULTS


While patients after TURP predominantly suffered from anejaculation (52%), diminished ejaculation was found more often after PAE (40%). Significantly higher MSHQ-EjD scores were found 3 months after PAE and at a median follow-up of 31 months. Histological examination showed marked changes of structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts) after PAE.
CONCLUSION


Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.",2020,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","['participants with assessable ejaculation', 'Ejaculatory disorders after prostatic artery embolization']","['prostatic artery embolization (PAE', 'PAE and transurethral resection of the prostate (TURP', 'TURP']","['MSHQ-EjD scores', 'ejaculation', 'Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function', 'structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts']","[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235969', 'cui_str': 'Disorder of ejaculation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C0013747', 'cui_str': 'Ejaculatory duct structure'}]",,0.0316888,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","[{'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Müllhaupt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. gautier.muellhaupt@kssg.ch.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hechelhammer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Pierre-André', 'Initials': 'PA', 'LastName': 'Diener', 'Affiliation': 'Department of Pathology, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Engeler', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Güsewell', 'Affiliation': 'Clinical Trials Unit, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}]",World journal of urology,['10.1007/s00345-019-03036-7']
2038,32961569,The Role of Coconut Oil in Treating Patients Affected by Plaque-Induced Gingivitis: A Pilot Study.,"OBJECTIVES


The aim of the study was to evaluate the coconut oil pulling efficacy as adjuvant in reducing plaque formation and in treating plaque-induced gingivitis.
MATERIALS AND METHODS


A sample of 20 patients was divided into two groups: a study and a control group. In the study group, coconut oil, in form of mouthwash, was administered to a sample of patients affected by gingivitis, aged between 18 and 35. The protocol established a daily application of the product for 30 days, where clinical parameters for plaque formation and gingivitis-plaque index (PI), bleeding index (BI)-will be evaluated during the recalls on a specific periodontal chart. The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1). The data were statistically analyzed using Student's  t -test, establishing the significance level as  p  < 0.05.
RESULTS


PI and BI decreased in both groups, with a more relevant and significant drop in the study group, from a mean value of PI of 58.0 to 19.3 and a mean value of BI of 33.5 to 5.0. In the control group, the values decreased, respectively, from 53.9 to 29.1 for PI, and from 33.5 to 16.2. Furthermore, no significant side effect was reported during coconut oil pulling therapy.
CONCLUSIONS


The collected data showed significant and promising improvements in reducing plaque formation and gingivitis. However, further researches have to be performed to have more consistent and statistically significant data on larger samples and to fully understand the mechanisms of action and effectiveness.",2020,The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1).,"['20 patients', 'patients affected by gingivitis, aged between 18 and 35', 'Treating Patients Affected by Plaque-Induced Gingivitis']","['coconut oil', 'Coconut Oil']","['PI and BI', 'plaque formation', 'plaque formation and gingivitis-plaque index (PI), bleeding index', 'plaque formation and gingivitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0056060', 'cui_str': 'Coconut Oil'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",20.0,0.0257104,The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1).,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ripari', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Filippone', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zumbo', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Covello', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zara', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Iole', 'Initials': 'I', 'LastName': 'Vozza', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}]",European journal of dentistry,['10.1055/s-0040-1714194']
2039,32962509,Non-immersive 3D virtual stimulus alter the time production task performance and increase the EEG theta power in dorsolateral prefrontal cortex.,"AIM


The study investigated the cortical activity changes and time production task performance induced by changes in motion speed of a non-immersive 3D virtual stimulus.
MATERIAL AND METHODS


Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus. In addition, the electroencephalographic analysis of the theta band power in the dorsolateral prefrontal cortex was done simultaneously with time production task execution.
RESULTS


The results demonstrated that in the slow speed condition, there is an increase in the error in the time production task after virtual reality ( p  < 0.05). There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions ( p  < 0.05).
CONCLUSIONS


We propose that the modulations of speed of virtual stimulus may underlie the accumulation of temporal pulses, which could be responsible for changes in the performance of the production task of the time intervals and a substantial increase in right dorsolateral prefrontal cortex activity related to attention and memory, acting in cognitive domains of supraseconds.",2020,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"['Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus']",['Material and Methods '],"['cortical activity changes and time production task performance', 'time production task', 'EEG theta power', 'time production task performance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",21.0,0.0239566,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"[{'ForeName': 'Diandra Caroline', 'Initials': 'DC', 'LastName': 'Martins E Silva', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Teles', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Escórcio', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Freitas', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Monara', 'Initials': 'M', 'LastName': 'Nunes', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Juliana Bittencourt', 'Initials': 'JB', 'LastName': 'Marques', 'Affiliation': 'Laboratory of Neurophysiology and Neuropsychology of Attention, Veiga de Almeida University, Cabo Frio, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Masters and PhD Program in Biomedical Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, USA.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1826945']
2040,32970396,Dapagliflozin in Patients with Chronic Kidney Disease.,"BACKGROUND


Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.
METHODS


We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
RESULTS


The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P = 0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed.
CONCLUSIONS


Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number, NCT03036150.).",2020,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"['patients with chronic kidney disease, with or without type 2 diabetes', 'Patients with chronic kidney disease', 'participants with type 2 diabetes and in those without type 2 diabetes', 'patients with chronic kidney disease', '4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a', 'Patients with Chronic Kidney Disease']","['placebo', 'urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin', 'Dapagliflozin', 'dapagliflozin']","['composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes', 'stage kidney disease, or death from renal causes', 'hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure', 'Death', 'death from renal or cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",4304.0,0.730754,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Fan-Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Roberto D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2024816']
2041,32967974,A stepped-wedge randomized trial and qualitative survey of HIV pre-exposure prophylaxis uptake in the Eswatini population.,"Clinical trials have shown that antiretroviral drugs used as pre-exposure prophylaxis (PrEP) are highly effective for preventing HIV acquisition. PrEP efforts, including in sub-Saharan Africa, have almost exclusively focused on certain priority groups, particularly female sex workers, men having sex with men, pregnant women, serodiscordant couples, and young women. As part of a PrEP demonstration project involving the general population at six primary health care facilities in Eswatini (formerly Swaziland), we conducted a randomized trial of a health care facility-based PrEP promotion package designed to increase PrEP uptake. Over the 18-month study duration, 33.6% (517 of 1538) of adults identified by health care workers as being at risk of acquiring HIV took up PrEP, and 30.0% of these individuals attended all scheduled appointments during the first 6 months after initiation of PrEP. The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility. When asked how PrEP uptake could be improved in 217 accompanying in-depth qualitative interviews, interviewees recommended an expansion of PrEP promotion activities beyond health care facilities to communities. Although a health care facility-based promotion package improved PrEP uptake, both uptake and retention remained low. Expanding promotion activities to the community is needed to achieve greater PrEP coverage among adults at risk of HIV infection in Eswatini and similar settings.",2020,"The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility.","['Eswatini population', 'female sex workers, men having sex with men, pregnant women, serodiscordant couples, and young women', 'general population at six primary health care facilities in Eswatini (formerly Swaziland']",['health care facility-based PrEP promotion package'],['PrEP uptake'],"[{'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]",,0.0278846,"The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94035, USA. till.baernighausen@uni-heidelberg.de pgeldsetzer@stanford.edu.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'McMahon', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, CH-1211 Geneva 27, Switzerland.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA 94115, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kohler', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Simiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Phiwayinkhosi', 'Initials': 'P', 'LastName': 'Dlamini', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Mxolisi', 'Initials': 'M', 'LastName': 'Mavuso', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Hughey', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Sindy', 'Initials': 'S', 'LastName': 'Matse', 'Affiliation': 'Eswatini National AIDS Programme, Ministry of Health, Government of the Kingdom of Eswatini, Mbabane H100, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany. till.baernighausen@uni-heidelberg.de pgeldsetzer@stanford.edu.'}]",Science translational medicine,['10.1126/scitranslmed.aba4487']
2042,32955801,"Hydroxychloroquine for prophylaxis of COVID-19 physicians survey: Despite lack of evidence, many would take or give to dear ones, and despite the perceived necessity of an RCT, few would participate.","INTRODUCTION


There was no evidence concerning the prophylaxis with hydroxychloroquine, and only low-grade evidence regarding the use of hydroxychloroquine as a treatment for COVID-19 patients. We performed a survey among Romanian physicians in order to see how many of them would administer prophylactically hydroxychloroquine to themselves or to people close to them, and if they would participate to a randomized controlled trial.
METHODS


Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients.
RESULTS


A total of 785 answers were collected. Nine physicians (1.1%) thought that there was clear evidence on prescribing hydroxychloroquine prophylaxis, 375 (48%) considered the evidence acceptable, 348 (44.3%) considered it weak, whereas 53 (6.8%) answered there was no evidence. 59 (7.5%) respondents were determined to take it (of which 31 = 4% already took), 192 (24.5%) were inclined to take, 271 (34.5%) were not decided yet. 175 (22.3%) of respondents declared they (would) give the treatment to their close ones, and this decision was associated with a higher age (P = 0.003), and the opinion that there was evidence (P < 0.001). When asked about the source of the treatment regimen, 286 (36.4%) indicated a scientific paper, while no scientific paper about the prophylaxis with hydroxychloroquine existed at that time. 718 (91.5%) considered a randomized clinical trial necessary (RCT), but only 333 (42.4%) answered they would enrol in such a trial. There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT.
CONCLUSIONS


Despite the lack of evidence, many physicians considered the evidence as existing, and were ready to take or to give hydroxychloroquine prophylactically to family. They considered an RCT necessary, but they were not willing to participate.",2020,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","['Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients', 'COVID-19 patients']","['RCT', 'hydroxychloroquine', 'Hydroxychloroquine']",[],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],785.0,0.0736841,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Baicus', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Pinte', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Stoichitoiu', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Badea', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13484']
2043,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
2044,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
2045,32957331,Effect of sitting and lying Liuzijue for lung rehabilitation in acute exacerbation of chronic obstructive pulmonary disease patients with non-invasive ventilation: Study protocol for a randomized controlled trial.,"INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is a lung disease with the highest incidence and high mortality in the world. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) can significantly accelerate the progression of the disease. Pulmonary rehabilitation is one of the effective treatment methods in COPD patients, but few studies have focused on the effect of pulmonary rehabilitation in AECOPD patients. Liuzijue can improve the pulmonary function and relieve symptoms of COPD patients. However, due to the influence of disease and non-invasive ventilation (NIV), AECOPD patients have poor compliance with getting out of bed at the early stage. Sitting and lying Liuzijue is more suitable in AECOPD patients with NIV. Therefore, this study will evaluate the effect of sitting and lying Liuzijue for lung function, exercise endurance, and quality of life in AEOPD patients with NIV.
METHODS


This study is a clinical randomized controlled trial. Sixty four AECOPD patients with NIV will be randomly divided into the experimental group and the control group. All participants will be treated with routine treatment and nursing according to their specific condition. The experimental group will be combined with sitting and lying Liuzijue on the basis of the control group. The duration of the exercise will be 3 months. The primary outcomes are the pulmonary function test and 6-minute walking test (6MWT). The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]). The measurement of outcomes will be evaluated at week 13.
DISCUSSION


It's imperative to focus on pulmonary rehabilitation in AECOPD patients. The purpose of this study is to evaluate the effect of sitting and lying Liuzijue for pulmonary rehabilitation in AECOPD patients with NIV.
TRIAL REGISTRATION


ChiCTR2000034530, Registered on July 8th, 2020.",2020,"The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]).","['COPD patients', 'chronic obstructive pulmonary disease patients with non-invasive ventilation', 'AECOPD patients with NIV', 'Sixty four AECOPD patients with NIV', 'AECOPD patients', 'AEOPD patients with NIV', 'chronic obstructive pulmonary disease (AECOPD']","['sitting and lying Liuzijue', 'Liuzijue']","['pulmonary function test and 6-minute walking test (6MWT', 'lung function, exercise endurance, and quality of life', 'pulmonary function', 'blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0376081,"The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Rensong', 'Initials': 'R', 'LastName': 'Yue', 'Affiliation': 'Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, P.R. China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiurun', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022111']
2046,32957332,Effect of Shexiang Tongxin dropping pill on stable coronary artery disease patients with normal fractional flow reserve and coronary microvascular disease: A study protocol.,"INTRODUCTION


Coronary microvascular disease (CMVD) can affect the structure, function, and metabolism of the heart, and has an important impact on the occurrence, development and prognosis of coronary artery disease (CAD). Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction. This study aims to assess the impact of STDP on stable coronary artery disease (SCAD) patients with normal FFR and CMVD.
METHODS AND ANALYSIS


This is a single-center, prospective randomized trial that will enroll 64 SCAD patients, CAD with normal FFR and CMVD. Patients will be randomly divided into study group and control group in a 1:1 fashion. On the basis of conventional drug treatment, the former will receive STDP while the latter will not. The follow-up period of the subjects is 12 months, and clinical follow-up will be conducted before discharge, 30 days, 3 months, 6 months, and 12 months after procedure to complete the detection of relevant indicators. The primary endpoint is the change of index of microcirculatory resistance (ΔIMR) at 12-month follow-up.
DISCUSSION


The present study will be the first randomized control study to evaluate the efficacy and safety of STDP on SCAD patients, CAD with normal FFR and CMVD, which will provide a broader idea and more experimental basis for improving the treatment of CMVD.
TRIAL REGISTRATION


This is a protocol for the randomized clinical trial which has been registered in the Chinese clinical Trial Registry with an identifier: ChiCTR2000032429.",2020,"Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction.","['stable coronary artery disease patients with normal fractional flow reserve and coronary microvascular disease', 'mice with myocardial infarction', 'stable coronary artery disease (SCAD) patients with normal FFR and CMVD', '64 SCAD patients, CAD with normal FFR and CMVD']","['Shexiang Tongxin dropping pill (STDP', 'STDP', 'Shexiang Tongxin dropping pill']","['coronary microvascular function', 'efficacy and safety', 'change of index of microcirculatory resistance (ΔIMR']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4079279', 'cui_str': 'shexiang tongxin'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",64.0,0.0754199,"Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction.","[{'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Jiefang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Chongying', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Junhui', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Fuyu', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022126']
2047,32957334,Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol.,"INTRODUCTION


In activities involving upper limbs, patients with chronic obstructive pulmonary disease (COPD) report an increase in dyspnea. For this reason, the authors of the recommendations about pulmonary rehabilitation propose to perform upper limbs muscle strengthening in patients with COPD. However, the modalities of strengthening are not clearly established.The aim of this study is to compare the effects of upper limbs endurance strengthening versus upper limbs force strengthening, in patients with COPD during a pulmonary rehabilitation program.
METHODS


This study is a randomized, open-label, bi-center controlled trial in parallel groups distributed in a ratio (1:1) comparing upper limbs force strengthening (group F) to the upper limbs endurance strengthening (group E) during a pulmonary rehabilitation program in patients with COPD stages 2 to 4 (A-D).After randomization, patients will be allocated to follow: A 4 weeks pulmonary rehabilitation program with upper limbs resistance strengthening (group F). A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire. The secondary outcomes are dyspnea (using Modified Medical Research Council dyspnea Scale, dyspnea-12 questionnaire, multidimensional dyspnea profile questionnaire), upper limb exercise capacity (using the 6-minute Peg Board and Ring Test), Maximal voluntary strength of deltoid, biceps, and brachial triceps.The sample size calculated is 140 patients per group, or 280 in total.
DISCUSSION


The modalities of upper limb strengthening are not very well known, and evidence based is lacking to recommend endurance or resistance upper limb strengthening.We anticipate that the results of this study will be of relevance to clinical practice. They will bring information about the best modality of upper limb strengthening to use during a pulmonary rehabilitation program.
TRIAL REGISTRATION


IdRCB n°2018-A00955-50; V1.1 du 11/07/2018; REHABSUP, clinical trial.gov (NCT03611036), registered August 02, 2018, https://clinicaltrials.gov/ct2/show/NCT03611036.",2020,A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire.,"['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'chronic obstructive pulmonary disease', '140 patients per group, or 280 in total', 'patients with COPD during a pulmonary rehabilitation program']","['pulmonary rehabilitation program with upper limbs resistance strengthening (group F', 'pulmonary rehabilitation program with upper limbs endurance strengthening', 'upper limb muscles training', 'upper limbs force strengthening (group F) to the upper limbs endurance strengthening (group E) during a pulmonary rehabilitation program', 'upper limbs endurance strengthening versus upper limbs force strengthening']","['dyspnea', 'dyspnea (using Modified Medical Research Council dyspnea Scale, dyspnea-12 questionnaire, multidimensional dyspnea profile questionnaire), upper limb exercise capacity (using the 6-minute Peg Board and Ring Test), Maximal voluntary strength of deltoid, biceps, and brachial triceps', 'dyspnea measured with the London Chest Activity of daily Living questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441839', 'cui_str': 'Group E'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0769542,A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Péran', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Anne Cécile', 'Initials': 'AC', 'LastName': 'Berriet', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Le Ber', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Le Mevel', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Courtois-Communier', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1412, University Hospital of Brest.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Department of Internal Medicine and Chest Diseases, EA3878 (GETBO), CIC INSERM 1412, University Hospital of Brest, European University of Occidental Brittany, Brest, France.'}]",Medicine,['10.1097/MD.0000000000022131']
2048,32957336,The prolongation effect of ilaprazole-based standard triple therapy for Helicobacter pylori.,"BACKGROUND


Helicobacter pylori (HP) infection causes many diseases, such as peptic ulcers, gastritis and gastric cancer, and MALToma. It has been gradually accepted that all HP-infected patients should be treated because HP is regarded as an infection. Therefore, the importance of selecting the optimal treatment regimen has increased. Although the 14-day standard triple therapy (STT) is recommended in the current guidelines, prolonging treatment duration is controversial in real practice because of inconsistent results from previous data and the risk of adverse effects. Additionally, the effect of STT using ilaprazole has not been reported until now. We aimed to compare the eradication rate between 7 and 10 days STT using ilaprazole.
METHODS


A prospective randomized controlled trial was conducted, which was divided into 2 treatment groups: the control group was 7 days of STT, and the test group was 10 days of STT. The eradication regimen was 10 mg ilaprazole, 500 mg clarithromycin, and 1000 mg amoxicillin twice daily. We included patients who were diagnosed with positive results of H pylori examination. We compared the HP eradication rate according to treatment duration, CYP2C19 subtype and endoscopic diagnosis.
RESULTS


We enrolled a total of 254 patients consisting of 127 patients in each treatment arm. The eradication rates of the control and test groups were 65.4% (82/127) and 74.8% (95/127), respectively, in the intention-to-treat analysis (P = .1). In the per-protocol analysis, 70.3% (83/118) and 82.6% (94/115) were eradicated in each group, which was statistically significant (P = .027). The CYP2C19 subtype was examined in 230 patients. The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (P = .704).
CONCLUSION


Ten-day STT was more effective than 7-day STT for HP eradication. The eradication rate was not affected by the CYP2C19 genotype.",2020,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","['Helicobacter pylori', '254 patients consisting of 127 patients in each treatment arm', 'patients who were diagnosed with positive results of H pylori examination', '230 patients']","['14-day standard triple therapy (STT', 'clarithromycin', 'amoxicillin', 'ilaprazole-based standard triple therapy']","['eradication rates', 'eradication rate', 'HP eradication rate']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",254.0,0.0711825,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","[{'ForeName': 'Seung Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sae Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Kyung Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Sun Moon', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Jae Kyu', 'Initials': 'JK', 'LastName': 'Sung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, Chungnam National University School of Medicine, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}]",Medicine,['10.1097/MD.0000000000022137']
2049,32961360,COVID-19 hits a trial: Arguments against hastily deviating from the plan.,"The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2200 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.",2020,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","['patients with advanced chronic heart failure', '2400 patients when the disease outbreak reached Germany']",['digitoxin and placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],2400.0,0.116561,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: grosshennig.anika@mh-hannover.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: koch.armin@mh-hannover.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106155']
2050,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2051,32961445,"Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.","OBJECTIVES


In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
MATERIALS AND METHODS


Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
RESULTS


In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
CONCLUSION


Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.",2020,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","['Treatment-naïve patients with ES-SCLC received 4 cycles of', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'extensive-stage small-cell lung cancer (CASPIAN']","['first-line durvalumab plus platinum-etoposide versus platinum-etoposide', 'cisplatin or carboplatin (EP', 'EP alone', 'durvalumab plus EP']","['appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.\nCONCLUSION\n\n\nAddition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'Cancer (EORTC', 'appetite loss', 'chest pain 0.76', 'symptom burden', 'symptoms (cough, dyspnea, chest pain, fatigue, appetite loss', 'overall survival', 'Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.142705,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Center, Omsk, Russian Federation.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russian Federation.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Laud', 'Affiliation': 'Statistical Services Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Shire', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.003']
2052,32961461,"Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study.","BACKGROUND


Low self-efficacy affects new mothers' ability to sustain breastfeeding. Interventions that increase self-efficacy could improve sustained breastfeeding.
OBJECTIVES


To develop an integrated breastfeeding education program based on self-efficacy theory, and evaluate the effect of the intervention on first-time mothers' breastfeeding self-efficacy and attitudes.
DESIGN


A single-blind, randomised controlled trial.
SETTING


A prenatal clinic of a teaching hospital.
PARTICIPANTS


First-time mothers with a singleton pregnancy (12-32 weeks' gestation) and their support partners were selected by convenience sampling (N = 104) and allocated by block-randomization to an intervention or control group.
METHODS


A 3-week breastfeeding intervention program was developed based on self-efficacy theory. The intervention group received the breastfeeding program; the control group received standard care. Data between groups were compared for scores on breastfeeding self-efficacy, infant feeding attitude, and breastfeeding practice, which were assessed using the Breastfeeding Self-Efficacy Scale-Short Form, the Iowa Infant Feeding Attitude Scale, and a structured questionnaire, respectively. Repeated data measurements were collected at baseline, 36-weeks' gestation, and postpartum at 1-week, and 1-, 3-, and 6-months.
RESULTS


Ninety-three mothers completed the study. Data were compared for the self-efficacy intervention group (n = 50) with the control group (n = 43). Baseline measures did not differ between groups. The intervention group had significantly higher breastfeeding self-efficacy at 36 weeks' gestation (mean difference (MD): 7.3, p < .001), and postpartum at 1-week (p < .001), 1-month (p < .001) and 3-months (p < .01) with MD: 6.7, 7.9, and 8.1, respectively; differences in scores from baseline were also significantly greater from 36 weeks' gestation to 3-months (MD from 9.1~9.9, p < .001) and 6-months postpartum (MD: 7.0, p < .05). Infant feeding attitude scores significantly improved from 36 weeks' gestation to 6-months postpartum for the intervention group (MD from 3.5~7.4, p < .05). Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week (98% vs. 86%), 1-month (100% vs. 90.7%), and 3-months (94% vs. 76.7%). Odds ratio (OR) postpartum for exclusive and predominant breastfeeding was greater for the intervention group at 3-months (OR = 4.7, 95% Confidence interval (CI), 1.2 -18.6; p = .05) and for exclusive breastfeeding at 6-months (OR: 2.82, 95% CI 1.0-8.1; p = .05).
CONCLUSIONS


The breastfeeding education intervention improved breastfeeding self-efficacy, infant feeding attitudes, and exclusive breastfeeding rates. The breastfeeding education program could be effective for sustaining breastfeeding in new mothers.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT03807726).",2020,Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week,"[""First-time mothers with a singleton pregnancy (12-32 weeks' gestation) and their support partners were selected by convenience sampling (N\xa0=\xa0104) and allocated by"", 'A prenatal clinic of a teaching hospital', 'Ninety-three mothers completed the study']","['breastfeeding program; the control group received standard care', 'integrated breastfeeding education program', 'block-randomization to an intervention or control group']","['breastfeeding self-efficacy, infant feeding attitude, and breastfeeding practice', 'Odds ratio (OR) postpartum for exclusive and predominant breastfeeding', 'Infant feeding attitude scores', 'Breastfeeding Self-Efficacy Scale-Short Form, the Iowa Infant Feeding Attitude Scale', 'Rates for exclusive and predominant breastfeeding postpartum', 'breastfeeding self-efficacy, infant feeding attitudes, and exclusive breastfeeding rates', 'self-efficacy', 'self-efficacy and exclusive breastfeeding rate', 'breastfeeding self-efficacy']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",104.0,0.0829758,Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week,"[{'ForeName': 'Juei-Fen', 'Initials': 'JF', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Tri-service General Hospital, Taipei, Taiwan; School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan.'}, {'ForeName': 'Su-Ru', 'Initials': 'SR', 'LastName': 'Chen', 'Affiliation': 'School of Nursing and Post-Baccalaureate Program in Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan. Electronic address: suru@tmu.edu.tw.'}, {'ForeName': 'Heng-Kien', 'Initials': 'HK', 'LastName': 'Au', 'Affiliation': 'Department of Obstetrics, Taipei Medical University Hospital, Taipei, Taiwan; Department of Obstetrics and Gynecology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; TMU Research Center for Cell Therapy and Regeneration Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Roselyn', 'Initials': 'R', 'LastName': 'Chipojola', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan; Kamuzu College of Nursing, Lilongwe, Malawi.'}, {'ForeName': 'Gabrielle T', 'Initials': 'GT', 'LastName': 'Lee', 'Affiliation': 'Applied Psychology, Faculty of Education, Western University, London, ON, Canada. Electronic address: glee329@uwo.ca.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: pihsia@tmu.edu.tw.'}, {'ForeName': 'Meei-Ling', 'Initials': 'ML', 'LastName': 'Shyu', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: meeiling@tmu.edu.tw.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Kuo', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: sykuo@tmu.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103770']
2053,32961500,One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.,"OBJECTIVE


Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning.
METHODS


Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months.
RESULTS


The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population.
CONCLUSIONS


The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.",2020,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"['patients undergoing surgery', 'older Veterans', 'patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning', 'Four hundred and thirty Veterans', 'at-risk veterans', 'women and younger adults who are underrepresented in this veteran population']","['Acceptance and Commitment Therapy workshop or one-day education and attention control workshop', 'behavioral intervention']","['pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills', 'total knee arthroplasty (TKA) with distress and/or pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",430.0,0.299537,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Derrecka M', 'Initials': 'DM', 'LastName': 'Boykin', 'Affiliation': 'South Central Mental Illness, Research and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Green', 'Affiliation': 'Michael E. DeBakey Veteran Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Buckwalter', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Garvin', 'Affiliation': 'Department of Psychiatry, University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Cortesi', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America. Electronic address: barbara-rakel@uiowa.edu.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110250']
2054,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
2055,32967000,A robust and reproducible connectome fingerprint of ketamine is highly associated with the connectomic signature of antidepressants.,"Over the past decade, various N-methyl-D-aspartate modulators have failed in clinical trials, underscoring the challenges of developing novel rapid-acting antidepressants based solely on the receptor or regional targets of ketamine. Thus, identifying the effect of ketamine on the brain circuitry and networks is becoming increasingly critical. In this longitudinal functional magnetic resonance imaging study of data from 265 participants, we used a validated predictive model approach that allows the full assessment of brain functional connectivity, without the need for seed selection or connectivity summaries. First, we identified a connectome fingerprint (CFP) in healthy participants (Cohort A, n = 25) during intravenous infusion of a subanesthetic dose of ketamine, compared to normal saline. We then demonstrated the robustness and reproducibility of the discovered ketamine CFP in two separate healthy samples (Cohort B, n = 22; Cohort C, n = 18). Finally, we investigated the ketamine CFP connectivity at 1-week post treatment in major depressive disorder patients randomized to 8 weeks of sertraline or placebo (Cohort D, n = 200). We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain. Compared to placebo, the ketamine CFP connectivity changes at 1 week predicted response to sertraline at 8 weeks. In each of Cohorts A-C, ketamine significantly increased connectivity in a previously identified antidepressant CFP. Investigating the brain connectivity networks, we successfully identified a robust and reproducible ketamine biomarker that is related to the mechanisms of antidepressants.",2020,"We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain.","['healthy participants (Cohort A, n\u2009=\u200925) during', '265 participants', 'major depressive disorder patients']","['intravenous infusion of a subanesthetic dose of ketamine', 'ketamine', 'ketamine CFP', 'sertraline or placebo', 'placebo', 'connectome fingerprint (CFP', 'normal saline']","['ketamine CFP connectivity', 'ketamine CFP connectivity changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C3494406', 'cui_str': 'Connectome'}, {'cui': 'C0016126', 'cui_str': 'Fingerprints'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C3494406', 'cui_str': 'Connectome'}, {'cui': 'C0016126', 'cui_str': 'Fingerprints'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",265.0,0.0674463,"We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain.","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA. chadi.abdallah@bcm.edu.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Averill', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Fouda', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deepak C', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'San Francisco VA Medical Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Naomi R', 'Initials': 'NR', 'LastName': 'Driesen', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00864-9']
2056,32975159,Effect of a Housing Intervention on Selected Cardiovascular Risk Factors Among Homeless Adults With Mental Illness: 24-Month Follow-Up of a Randomized Controlled Trial.,"Background Cardiovascular disease is a leading cause of mortality among people experiencing homelessness. This study investigated whether housing intervention affects cardiovascular disease risk factors among homeless adults with mental illnesses over a 24-month period. Methods and Results We conducted a randomized controlled trial of a Housing First intervention that provided community-based scattered-site housing and support services. Five hundred seventy-five participants were randomized to the intervention (n=301) or treatment as usual (TAU) (n=274). Analyses were performed according to the intention-to-treat principle using generalized estimating equations. There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use. However, the intervention had an impact on reducing the number of days of alcohol intoxication by 1.58 days compared with TAU (95% CI, -2.88 to -0.27,  P =0.0018). Over the 24-month period, both the intervention and TAU groups had significant reductions in tobacco and cocaine use. Conclusions The intervention, compared with TAU, did not result in greater improvements in many of the selected cardiovascular risk factors. Since the study took place in a service-rich city with a range of pre-existing supportive services and universal health insurance, the high level of usual services available to the TAU group may have contributed to reductions in their cardiovascular disease risk factors. Further research is needed to develop interventions to reduce risk factors of cardiovascular disease among people experiencing homelessness and mental illness beyond existing treatments. REGISTRATION www.isrctn.comURL: www.isrctn.com. Unique Identifier: ISRCTN42520374.",2020,"There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use.","['people experiencing homelessness', 'Five hundred seventy-five participants', 'homeless adults with mental illnesses over a 24-month period', 'Homeless Adults With Mental Illness']","['Housing First intervention that provided community-based scattered-site housing and support services', 'Housing Intervention', 'housing intervention']","['Selected Cardiovascular Risk Factors', 'blood pressure, tobacco, and cocaine/crack use', 'cardiovascular disease risk factors', 'number of days of alcohol intoxication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",575.0,0.137546,"There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use.","[{'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Chum', 'Affiliation': 'Brock University St. Catharines ON Canada.'}, {'ForeName': 'Ri', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Rosane', 'Initials': 'R', 'LastName': 'Nisenbaum', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016896']
2057,32975823,Thermal suit connected to a forced-air warming unit for preventing intraoperative hypothermia: A randomised controlled trial.,"BACKGROUND


Inadvertent intraoperative hypothermia is a common occurrence in surgical patients. A thermal suit is an option for passive insulation. However, active warming is known to be more effective. Therefore, we hypothesised that a forced-air warming (FAW) unit connected to the thermal suit is superior to a commercial FAW blanket and a warming mattress in breast cancer surgery.
METHODS


Forty patients were randomised to this prospective, clinical trial to wear either the thermal suit or conventional hospital clothes under general anaesthesia. The Thermal suit group had a FAW unit set to 38°C and connected to the legs of the suit. The Hospital clothes group had a lower body blanket set to 38°C and a warming mattress set to 37°C. Core temperature was measured with zero-heat-flux sensor. The primary outcome was core temperature on admission to the recovery room.
RESULTS


There was no difference in mean core temperatures at anaesthetic induction (P = .4) or on admission to the recovery room (P = .07). One patient in the Thermal suit group (5%) vs six patients in the Hospital clothes group (32%) suffered from intraoperative hypothermia (P = .04, 95% CI 1.9%-49%). Mean skin temperatures (MSTs) were higher in the Thermal suit group during anaesthesia. No burns or skin irritations were reported. Two patients in the Thermal suit group sweated.
CONCLUSIONS


A thermal suit connected to a FAW unit was not superior to a commercial FAW blanket, although the incidence of intraoperative hypothermia was lower in patients treated with a thermal suit.",2020,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"['Forty patients', 'surgical patients']","['Thermal suit connected to a forced-air warming unit', 'thermal suit or conventional hospital clothes under general anaesthesia']","['mean core temperatures at anaesthetic induction', 'Mean skin temperatures', 'core temperature on admission to the recovery room', 'intraoperative hypothermia', 'No burns or skin irritations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}]",40.0,0.0619649,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"[{'ForeName': 'Sirkka-Liisa', 'Initials': 'SL', 'LastName': 'Lauronen', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marja-Tellervo', 'Initials': 'MT', 'LastName': 'Mäkinen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Annila', 'Affiliation': 'Department of Anaesthesia, Tays Hatanpää, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Maija-Liisa', 'Initials': 'ML', 'LastName': 'Kalliomäki', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13714']
2058,32971053,Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.,"BACKGROUND


Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.
METHODS


We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.
FINDINGS


Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; p superiority =0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; p non-inferiority =0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; p superiority <0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; p superiority =0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.
INTERPRETATION


In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.
FUNDING


The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.",2020,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","['After community-based HIV testing, people living with HIV', 'Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men', 'people living with HIV not on ART', 'men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group', 'rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda', 'for HIV in South Africa and Uganda (DO ART', 'people with detectable viral load']","['mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills', 'antiretroviral therapy (ART', 'community-based ART delivery', 'Community-based antiretroviral therapy versus standard clinic-based services']","['Viral suppression', 'HIV viral suppression', 'viral suppression']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",,0.528336,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: rbarnaba@uw.edu.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Szpiro', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asiimwe', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Ware', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meighan L', 'Initials': 'ML', 'LastName': 'Krows', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'van Heerden', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Monique A', 'Initials': 'MA', 'LastName': 'Wyatt', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kombi', 'Initials': 'K', 'LastName': 'Sausi', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Bosco', 'Initials': 'B', 'LastName': 'Turyamureeba', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Nsika', 'Initials': 'N', 'LastName': 'Sithole', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrienne E', 'Initials': 'AE', 'LastName': 'Shapiro', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D Allen', 'Initials': 'DA', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Koole', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'The Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30313-2']
2059,32971156,The effect of beta-glucan supplementation on glycemic control and variability in adolescents with type 1 diabetes mellitus.,"AIMS


This study aimed to investigate whether supplemental soluble fiber, oat β-glucan, has any effect on glycemic control and variability of adolescents with type 1 diabetes mellitus.
METHODS


This study was conducted in 30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week. At Phase I, all subjects followed a standard diet program. For Phase II and Phase III, the subjects continued their standard diet program and added natural oat flakes containing 3 g/day and 6 g/day β-glucan, respectively. Glucose levels were monitored by continuous glucose monitoring (CGM). The maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values in a target range and below and above a target values were calculated for each of the phases. Premeal, postmeal, peak blood glucose values and peak times of meals were evaluated for each of the phases. Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters.
RESULTS


The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p < 0.05). Minimal blood glucose levels were the highest at Phase III (p < 0.05). Phase I, II, and III showed similar durations elapsed for Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p > 0.05). Premeal and postmeal blood glucose levels were lowest at Phase III for breakfast, lunch, and overall (p < 0.05). The lowest peak blood glucose levels were detected at Phase III for breakfast, lunch, dinner and overall (p < 0.05). Phase III also showed delayed peaks for all time-points (p < 0.05 for each) compared to other phases. Phase III had significantly lower levels of SD, CV, LBGI, and CONGA levels than those in either Phase I or Phase II (p < 0.05 for each).
CONCLUSION


6 g/day oat β-glucan have favorable outcomes in glycemic control and variability in adolescents with type 1 diabetes mellitus.",2020,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","['Adolescents with Type 1 Diabetes Mellitus', '30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week', 'adolescents with type 1 diabetes mellitus']","['Beta-Glucan Supplementation', 'supplemental soluble fiber, oat β-glucan']","['lowest peak blood glucose levels', 'levels of SD, CV, LBGI, and CONGA levels', 'Premeal, postmeal, peak blood glucose values and peak times of meals', 'maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values', 'Glycemic Control and Variability', 'Glucose levels', 'maximal, mean and daytime and night blood glucose levels', 'Minimal blood glucose levels', 'Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters', 'glycemic control and variability', 'Premeal and postmeal blood glucose levels', 'Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p>0.05']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1134651', 'cui_str': 'Beta glucan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",30.0,0.00984219,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","[{'ForeName': 'Rukiye', 'Initials': 'R', 'LastName': 'Bozbulut', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey. Electronic address: dyt_rukiye@hotmail.com.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Şanlıer', 'Affiliation': 'Ankara Medipol University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Döğer', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bideci', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Çamurdan', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Peyami', 'Initials': 'P', 'LastName': 'Cinaz', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108464']
2060,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY


To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS


This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-min sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS


An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2nd (p = 0.003 and p < 0.001) and 7th (p = 0.043 and p = 0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2nd and 7th postpartum days (p > 0.05).
CONCLUSION


The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2020,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
2061,32950413,Is There Still Hope for Infrapopliteal PCB Angioplasty?: Positive Data From the ACOART-BTK Single-Center Randomized Trial.,,2020,,[],[],[],[],[],[],,0.0782123,,"[{'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Spiliopoulos', 'Affiliation': '2nd Department of Radiology, National and Kapodistrian University of Athens, ""Attikon"" University General Hospital, Athens, Greece. Electronic address: stavspiliop@med.uoa.gr.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Reppas', 'Affiliation': '2nd Department of Radiology, National and Kapodistrian University of Athens, ""Attikon"" University General Hospital, Athens, Greece.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.027']
2062,32950416,Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty.,"OBJECTIVES


The aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention.
BACKGROUND


Restenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results.
METHODS


ACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints.
RESULTS


From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred.
CONCLUSIONS


Litos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.",2020,Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30).,"['patients with critical limb ischemia undergoing below-the-knee (BTK) intervention', 'From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study']","['Litos drug-coated balloon (DCB', 'Acotec Drug-Eluting Balloon Versus Plain Balloon', 'angioplasty', 'plain old balloon angioplasty (POBA']","['Occlusive restenosis', 'Complete healing', 'rates of occlusive restenosis', 'efficacy and safety', 'LLL, vessel reocclusion', 'late lumen loss (LLL', 'target lesion revascularization', 'Mean lesion length', 'stenosis or occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]","[{'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0854571', 'cui_str': 'Reocclusion'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",105.0,0.093439,Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy. Electronic address: francescoliistro@hotmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angioli', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ventoruzzo', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ducci', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Matteo Rocco', 'Initials': 'MR', 'LastName': 'Reccia', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Falsini', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Scatena', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pieroni', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.045']
2063,32950419,Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study.,"OBJECTIVES


The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD).
BACKGROUND


Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far.
METHODS


The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months.
RESULTS


From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred.
CONCLUSIONS


Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).",2020,"No stent thrombosis events occurred.
","['patients with stable coronary artery disease (CAD', 'Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores\xa0<23 were included', 'Patients', 'selected low-risk patients with stable CAD', 'From February 22, 2018, to May 7, 2019, 201 patients were enrolled']","['Stable CAD', 'everolimus-eluting stent implantation', 'Coronary Artery Stenting', 'Aspirin', 'aspirin', 'Aspirin-Free Prasugrel Monotherapy']","['primary ischemic and bleeding endpoints', 'stent thrombosis events', 'composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3\xa0months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",201.0,0.0631436,"No stent thrombosis events occurred.
","[{'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Patricia O', 'Initials': 'PO', 'LastName': 'Guimarães', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'De Martino', 'Affiliation': 'Department of Internal Medicine, Discipline of Cardiology, University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Tinoco', 'Affiliation': 'Instituto Cardiovascular de Linhares LTDA - UNICOR, Linhares, Brazil.'}, {'ForeName': 'Expedito E', 'Initials': 'EE', 'LastName': 'Ribeiro', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cavalcante', 'Affiliation': 'Boston Scientific, Marlborough, Massachusetts.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Moulin', 'Affiliation': 'Associação Evangélica Beneficiente Espírito Santense, Vila Velha, Brazil.'}, {'ForeName': 'Breno A A', 'Initials': 'BAA', 'LastName': 'Falcão', 'Affiliation': 'Hospital Dr. Carlos Alberto Studart Gomes de Messejana, Fortaleza, Brazil.'}, {'ForeName': 'Rogerio S', 'Initials': 'RS', 'LastName': 'Leite', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil.'}, {'ForeName': 'Fernanda Barbosa', 'Initials': 'FB', 'LastName': 'de Almeida Sampaio', 'Affiliation': 'Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gustavo R', 'Initials': 'GR', 'LastName': 'Morais', 'Affiliation': 'Hospital Nossa Senhora das Neves, João Pessoa, Brazil.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Meireles', 'Affiliation': 'Hospital do Servidor Público Estadual - IAMSPE, São Paulo, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Campos', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: pedro.lemos@atscien.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.023']
2064,32951292,"Comparative evaluation of Gracilaria algae 3% cream vs Clobetasol 0.05% cream in treatment of plaque type psoriasis: A randomized, split-body, triple-blinded clinical trial.","Gracilaria algae is red macro algae which has demonstrated considerable anti-inflammatory effects. Our objective was to compare the efficacy of Gracilaria algae topical cream 3% vs Clobetasol cream 0.05% in treatment of plaque-type psoriasis. Thirty adult patients with baseline modified Psoriasis Area and Severity Index (PASI) score ≤12 were randomized to receive either Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8 weeks and follow-up of 4 weeks. Modified PASI score, patient's satisfaction using VAS and global physician assessment score were assessed to evaluate clinical response. Thirty patients with 94 symmetrical psoriasis plaques were enrolled in this trial. The mean baseline modified PASI score of both sides was similar; however, at the end of trial, modified PASI score was reduced more on the sides treated with Gracilaria algae cream (0.80 ± 0.19% vs 0.63 ± 0.25%, P < .05). No significant difference was found regarding mean physician global assessment score between the two groups (P > .05). Patients' satisfaction was significantly higher in favor of algae cream only at week 8 of the intervention (P < .05). Gracilaria algae cream can be an effective and safe alternative of Clobetasol in the treatment of plaque type psoriasis.",2020,No significant difference was found regarding Mean Physician Global Assessment score (PGA) between the 2 groups (p>0.05).,"['plaque-type psoriasis', '30 patients with 94 symmetrical psoriasis plaques', '30 adult patients with baseline modified PASI score ≤12']","['Gracilaria algae topical cream', 'Clobetasol cream', 'Gracilaria algae 3% cream versus Clobetasol 0.05% cream', 'Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8\u2009weeks and follow-up of 4\u2009weeks', 'Gracilaria algae cream']","[""Modified PASI score, patient's satisfaction using VAS and Global Physician Assessment score (GPA"", 'modified PASI score', 'plaque type psoriasis', 'mean baseline modified PASI score', 'Mean Physician Global Assessment score (PGA']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1092970', 'cui_str': 'Gracilaria'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.0624814,No significant difference was found regarding Mean Physician Global Assessment score (PGA) between the 2 groups (p>0.05).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Shatalebi', 'Affiliation': 'Novel Drug Delivery Systems Research Center, Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Safoura', 'Initials': 'S', 'LastName': 'Bokaie Jazi', 'Affiliation': 'Novel Drug Delivery Systems Research Center, Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Yegdaneh', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Iraji', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Siadat', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Noorshargh', 'Affiliation': 'Alzahra Hospital Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Dermatologic therapy,['10.1111/dth.14317']
2065,32957340,Analgesic effects of low-dose ketamine after spinal fusion in adults: A protocol of prospective randomized trial.,"BACKGROUND


Patients with spinal fusion often have opioid tolerance and chronic pain, which makes it difficult to control postoperative pain. In this double-blind, randomized, prospective study, we assessed the safety and efficacy of intravenous low-dose ketamine for the treatment of pain in patients undergoing the lumbar spinal fusion.
METHODS


This randomized, prospective, double-blind and placebo-controlled study was approved via the hospital institutional review committee. Patients were registered with signed written consent. All the floor nurses, recovery room and surgeons, patients, statisticians as well as research assistants were unaware of the grouping. The patients were randomly divided into ketamine group and control group by random number table. Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation. P < .05 was considered to be the statistically significant. The Statistical Package for the software of Social Sciences 20.0 was utilized for statistical analysis.
CONCLUSIONS


For the present trial, we assumed that intravenous ketamine could improve the satisfaction of patient by reducing the total consumption of morphine equivalent and the pain scores.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5896).",2020,"Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation.","['patients undergoing the lumbar spinal fusion', 'adults']","['low-dose ketamine', 'placebo', 'intravenous low-dose ketamine', 'ketamine']","['Analgesic effects', 'safety and efficacy', 'Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics', 'total consumption of morphine equivalent and the pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.297415,"Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Handan Central Hospital, Hebei Province, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Yongxue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022162']
2066,32957353,Observation for the effect of rTMS combined with magnetic stimulation at Neiguan (PC6) and Sanyinjiao (SP6) points on limb function after stroke: A study protocol.,"BACKGROUND


Stroke is the primary cause of adult disability in China, which causes serious personal, family, and social burden. ""Central peripheral central"" closed-loop rehabilitation theory is proved to be an effective neural rehabilitation model. Based on this theory, repetitive transcranial magnetic stimulation (rTMS) combined with magnetic stimulation of Neiguan (PC6) and Sanyinjiao (SP6) may be an effective treatment for limb dysfunction after stroke. However, the efficacy and mechanism of repetitive magnetic stimulation of M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points on limb dysfunction after stroke has not been confirmed.
METHODS/DESIGN


This study is a prospective, randomized, controlled, open trial. We randomly divided 42 subjects, aged 35 to 80 years, diagnosed with ischemic stroke within 1 month, into 2 groups with a ratio of 1:1. On the basis of this medical treatment, patients in the experimental group received 1 Hz rTMS in M1 area on the contralateral side, and 3 Hz rTMS treatment at Neiguan point and Sanyinjiao point on the affected side. The control group was treated with acupuncture (body acupuncture). All patients were treated once a day and followed up for 10 days. The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively. The modified Barthe index was followed up on the 30th day of treatment, and the adverse reactions were recorded at any time. The mechanism of rTMS will be revealed by Barthe index before treatment, on the 10th day of treatment and on the 30th day of follow-up. The results were analyzed by spss19.0 software, and the quantitative indexes were analyzed by t test and rank sum test. χ test was used for non-grade counting, and rank sum test was used for grade counting. All statistical tests were performed with bilateral test. If P value is less than or equal to .05, the difference will be considered statistically significant.
CONCLUSION


The purpose of this study was to determine the effect of repetitive magnetic stimulation of M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points on limb function after stroke. Through this study, we expect to explore a new scheme for the treatment of poststroke dyskinesia, and prove that compared with rTMS and acupuncture alone, the closed-loop rehabilitation theory based on ""center peripheral center"" can be more efficient and safe in the treatment of poststroke limb dysfunction.
TRIAL REGISTRATION


The trial was registered in China clinical trial registry (http://www.chictr.org.cn/index.aspx), ID: ChiCTR1900026890 (October 25, 2019).",2020,"The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively.","['limb function after stroke', '42 subjects, aged 35 to 80 years, diagnosed with ischemic stroke within 1 month, into 2 groups with a ratio of 1:1']","['M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points', 'rTMS and acupuncture', '1\u200aHz rTMS', 'acupuncture (body acupuncture', 'rTMS combined with magnetic stimulation at Neiguan (PC6) and Sanyinjiao (SP6) points', 'repetitive transcranial magnetic stimulation (rTMS) combined with magnetic stimulation of Neiguan (PC6) and Sanyinjiao (SP6']","['adverse reactions', 'limb function', 'National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability', 'limb dysfunction']","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0450548', 'cui_str': 'SP6'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",,0.0451603,"The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively.","[{'ForeName': 'Penglong', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Zucheng', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Dongling', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022207']
2067,32957356,The efficacy of nursing intervention to reduce preoperative anxiety in patients with total knee arthroplasty: A protocol of prospective randomized trial.,"BACKGROUND


Some patients undergoing the total knee arthroplasty (TKA) have suboptimal postoperative results, and preoperative anxiety may be one of the reasons for these unsatisfactory results. We perform this randomized control study protocol to determine the effectiveness of nursing intervention, on the basis of motivational interview, to decrease the preoperative anxiety in patients receiving TKA.
METHODS


This is a double-blinded, single-center, placebo-controlled and randomized trial, which will be conducted from December 2020 to June 2021. The protocol of this study was approved by the West China Hospital of Sichuan University (W20200803-28). Sixty patients who will undergo TKA are included in our study. Patients are randomly divided into experiential group (with 30 patients) and the control group (with 30 patients). The control group and experimental group receive an informative and separate session via nursing about the operation preparation and operation process. Both the control group and the experimental group are given habitual treatment, but the experimental group need to receive additional motivational interviews. The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale. Secondary outcome is postoperative pain, which is assessed by visual analogue scale .
RESULTS


Figure 1 will display the comparison of preoperative and postoperative total average anxiety scores in control group and the experimental group.
CONCLUSION


Preoperative psychological distress is familiar in our patients. We hypothesized that nursing intervention may be associated with reduced preoperative anxiety in the patients receiving TKA.",2020,The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale.,"['December 2020 to June 2021', 'patients receiving TKA', 'patients with total knee arthroplasty', 'West China Hospital of Sichuan University (W20200803-28', 'patients undergoing the total knee arthroplasty (TKA', 'Sixty patients who will undergo TKA are included in our study']","['placebo', 'informative and separate session via nursing about the operation preparation and operation process', 'nursing intervention']","['postoperative pain, which is assessed by visual analogue scale ', 'preoperative and postoperative total average anxiety scores', 'preoperative anxiety', 'Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0515531,The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale.,"[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Neurological Comprehensive Ward.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Neurological Comprehensive Ward.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Nursing, West China Hospital of Sichuan University/West China Nursing College, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022213']
2068,32958495,"Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.","INTRODUCTION


To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.
METHODS AND ANALYSIS


DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.
ETHICS AND DISSEMINATION


Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04315948 Eudra-CT 2020-000936-23.",2020,This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe.,"['hospitalised patients with COVID-19 in need of oxygen therapy', '3100 patients (620 patients per arm) is targeted', 'On 8 June 2020, 754 patients have been included', 'hospitalised adults', 'patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe', 'patients hospitalised with COVID-19']","['investigational re-purposed therapeutics relative to Standard of Care (SoC', 'control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC']","['clinical efficacy and safety', 'clinical status at Day 15 on the 7-point ordinal scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",3100.0,0.254259,This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe.,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ader', 'Affiliation': 'Infectious and tropical diseases department, Centre Hospitalier Universitaire de Lyon, F-69004 Lyon, and Inserm 1111-Centre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, CNRS, UMR5308, Ecole Normale Supérieure de Lyon, Univ Lyon, F-69007, Lyon, France florence.ader@chu-lyon.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-041437']
2069,32958537,The cost-effectiveness of using performance-based financing to deliver the basic package of health services in Afghanistan.,"Performance-based financing (PBF) is a mechanism to improve the quality and the utilisation of health benefit packages. There is a dearth of economic evaluations of PBF in the 'real world'. Afghanistan implemented PBF between 2010 and 2015 and evaluated the programme using a pragmatic cluster-randomised control trial. We conducted a cost-effectiveness analysis of the PBF programme in Afghanistan, compared with the standard of care, from the provider payer's perspective. The incremental cost-effectiveness ratio of PBF compared with the standard of care was US$1242 per disability-adjusted life year averted; not cost-effective when compared with an opportunity cost threshold of US$349. Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%). The unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services in the standard of care was US$0.96 (95% CI 0.92-1.0), US$4.8 (95% CI 4.1-6.3) and US$1.3 (95% CI 1.2-1.4), respectively, whereas the cost of ANC, SBA and PNC services per case in PBF areas were US$4.72 (95% CI 4.68-5.7), US$48.5 (95% CI 48.0-52.5) and US$5.4 (95% CI 5.1-5.9), respectively. To conclude, our study found that PBF, as implemented in the Afghan context, was not the best use of funds to strengthen the delivery of maternal and child health services. The cost-effectiveness of alternative PBF designs needs to be appraised before using PBF at scale to support health benefit packages. PBF needs to be considered in the context of funding the range of constraints that inhibit health service performance improvement.",2020,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).",['Afghanistan'],"['PBF programme', 'Performance-based financing (PBF']","['cost-effectiveness', 'unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services', 'staff time', 'incremental cost-effectiveness ratio of PBF', 'cost of ANC, SBA and PNC services per case in PBF areas', 'PBF financial cost']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0376243', 'cui_str': 'finances'}]",,0.0615825,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).","[{'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Salehi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK ahmad.salehi@lshtm.ac.uk.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Borghi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Blanchet', 'Affiliation': 'Centre for Education and Research in Humanitarian Action (CERAH), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vassall', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002381']
2070,32961273,High-definition transcranial direct current stimulation facilitates emotional face processing in individuals with high autistic traits: A sham-controlled study.,"The deficit in emotional face processing is a critical impairment for individuals with high autistic traits. The temporalparietal junction(TPJ) is considered to be closely related to emotional face processing. The aim of this study was to examine the effect of highdefinition transcranial direct current stimulation (HD-tDCS) over the right temporal-parietal junction (rTPJ) on facial emotion processing of individuals with high autistic traits using eye-tracking technology. Twenty-nine participants with high autistic traits completed an eyetracking task (including happy, fearful and neutral faces) before and after five consecutive days of stimulation (anodal or sham). Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation. Moreover, this increased effect of mouth recognition with anodal rTPJ HD-tDCS was shown in both happy and fearful faces, but no remarkable difference was found in neutral faces. These findings suggest that right TPJ anodal HD-tDCS can facilitate emotional face processing in individuals with high autistic traits.",2020,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","['Twenty-nine participants with high autistic traits', 'individuals with high autistic traits', 'individuals with high autistic traits using eye-tracking technology', 'Individuals with High Autistic Traits']","['High-Definition Transcranial Direct Current Stimulation Facilitates Emotional Face Processing', 'TPJ anodal HD-tDCS', 'anodal HD-tDCS', 'highdefinition transcranial direct current stimulation (HD-tDCS', 'anodal rTPJ HD-tDCS', 'eyetracking task (including happy, fearful and neutral faces', 'right temporal-parietal junction (rTPJ']","['facial emotion processing', 'fixation time and fixation count', 'neutral faces']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",29.0,0.0460479,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","[{'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Xuan', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qianhui', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Gongjun', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: zhanglei17236@aliyun.com.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135396']
2071,32969489,Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study.,"BACKGROUND


Children aged ≥ 6 to < 12 years with severe atopic dermatitis (AD) have limited treatment options. In a 16-week, randomized, placebo-controlled, phase III trial in children, dupilumab, a monoclonal antibody inhibiting interleukin (IL)-4/IL-13 signalling, significantly improved signs and symptoms with acceptable safety; longer-term safety and efficacy data are lacking.
OBJECTIVES


To report the pharmacokinetic profile and long-term safety and efficacy of dupilumab in children (aged ≥ 6 to < 12 years) with severe AD.
METHODS


Children (aged ≥ 6 to < 12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study and subsequent open-label extension (OLE) study. Patients received single-dose dupilumab 2 or 4 mg kg -1  followed by 8-week pharmacokinetic sampling, then 2 or 4 mg kg -1  weekly for 4 weeks (phase IIa), followed by the same weekly regimen (OLE). Primary endpoints were dupilumab concentration-time profile and treatment-emergent adverse events (TEAEs); secondary assessments included Eczema Area and Severity Index (EASI) and Peak Pruritus Numeric Rating Scale (PP-NRS) score.
RESULTS


Of 38 children enrolled, 37 completed phase IIa and 33 continued to the OLE. Nonlinear, target-mediated pharmacokinetics characterized dupilumab concentrations (week 24-48 mean serum concentrations: 2 mg kg -1  , 61-77 mg L -1  ; 4 mg kg -1  , 143-181 mg L -1  ). TEAEs were mostly mild to moderate and transient; none led to treatment discontinuation. The most commonly reported TEAEs were nasopharyngitis (2 mg kg -1  , 47%; 4 mg kg -1  , 56%) and AD exacerbation (29% and 13%, respectively). Single-dose dupilumab rapidly improved AD with further improvements through week 52. Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week 2 (phase IIa) and -92%/-84% and -70%/-58% at week 52 (OLE), respectively.
CONCLUSIONS


These safety and efficacy results support the use of dupilumab as a continuous long-term treatment for children aged ≥ 6 to < 12 years with severe AD.",2020,"Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week2 (phase IIa) and -92%/-84% and -70%/-58% at week52 (OLE), respectively.
","['children aged ≥6 to <12 years with severe AD', 'children (aged ≥6 to <12 years) with severe AD', 'Children aged ≥6 to <12 years with severe atopic dermatitis (AD', 'children aged ≥ 6 to < 12 years with uncontrolled, severe atopic dermatitis', 'Children (aged ≥6 to <12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open-label, ascending-dose, sequential-cohort study and subsequent open-label extension (OLE) study', '38 children enrolled, 37 completed phase IIa, 33 continued to the OLE']","['single-dose dupilumab 2 or 4 mg/kg followed by 8-week pharmacokinetic sampling', 'placebo', 'dupilumab', 'Dupilumab']","['Mean EASI and PP-NRS', 'nasopharyngitis ', 'dupilumab concentration-time profile and treatment-emergent adverse events (TEAEs); secondary assessments included Eczema Area and Severity Index (EASI) and Peak Pruritus Numeric Rating Scale (PP-NRS) score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.11131,"Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week2 (phase IIa) and -92%/-84% and -70%/-58% at week52 (OLE), respectively.
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center of Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'Departments of Dermatology, University of California San Diego School of Medicine, San Diego, CA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': 'Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boklage', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Guillemin', 'Affiliation': 'Sanofi, Chilly Mazarin, France.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kosloski', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': ""O'Malley"", 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}]",The British journal of dermatology,['10.1111/bjd.19460']
2072,32967390,Efficacy of Intradiscal Ozone Therapy with or without Periforaminal Steroid Injection on Lumbar Disc Herniation: A Double-Blinded Controlled Study.,"BACKGROUND


Intradiscal ozone therapy, a minimally invasive technique, is used in patients that do not respond to standard conservative therapies for low back pain due to degenerative disc-induced lumbar disc herniation (LDH). Many studies on clinical efficacy lack a standardized injection method and are limited by inadequate study design.
OBJECTIVE


This study aimed to determine the efficacy of periforaminal steroid injection together with intradiscal ozone therapy.
STUDY DESIGN


A prospective, double-blinded, randomized controlled trial.
SETTING


A tertiary care center.
METHODS


This study was conducted in 65 patients with low back and leg pain caused by LDH. Group 1 received intradiscal ozone therapy (n = 35) and Group 2 received intradiscal ozone therapy with periforaminal steroid injection (n = 30). Patients were evaluated for pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life using the short form 36 health survey administered pre-injection and at one and 6 months post-injection. All procedures were performed under sterile conditions using C-arm fluoroscopy.
RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection. Mean pre-injection VAS was not significantly different between the groups (VAS: 7.8 ± 1.1 for Group 1, 7.8 ± 1.2 for Group 2). VAS values at 6 months for Group 1 and Group 2 were as follows: 3.6 ± 2.4, 4.1 ± 1.6, respectively) (P < 0.001). Mean pre-injection ODI was not significantly different between the groups (ODI: 20.9 ± 9.6 for Group 1, 25.2 ± 10.3 for Group 2). ODI values at 6 months for Group 1 and Group 2 were as follows: 12.8 ± 9.2, 14.3 ± 7.2, respectively) (P < 0.001). However, there were no significant differences between the groups. Similarly, there was no significant difference between the 2 groups on any of these parameters.
LIMITATIONS


A limited number of patients and limited follow-up time.
CONCLUSION


This study showed that intradiscal ozone injection alone was sufficient to treat low back and leg pain caused by LDH and that periforaminal steroid injection does not provide additional benefit, which is contrary to the literature.",2020,"RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection.","['65 patients with low back and leg pain caused by LDH', 'Lumbar Disc Herniation', 'A tertiary care center']","['intradiscal ozone therapy with periforaminal steroid injection', 'Intradiscal Ozone Therapy with or without Periforaminal Steroid Injection', 'intradiscal ozone injection alone', 'periforaminal steroid injection together with intradiscal ozone therapy', 'intradiscal ozone therapy']","['pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life', 'ODI values', 'pain, disability, and quality of life', 'VAS values', 'Mean pre-injection VAS', 'Mean pre-injection ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",65.0,0.0853782,"RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection.","[{'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Ercalik', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kilic', 'Affiliation': '1Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey; 2Department of Neurosurgery, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.'}]",Pain physician,[]
2073,32967391,The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined with Pectoral Nerve Block in Modified Radical Mastectomy: A Prospective Randomized Trial.,"BACKGROUND


Pectoral nerve (Pecs) block is one of the most promising regional analgesic techniques for breast surgery. However, Pecs II block may not provide analgesia of the medial aspect of the breast or the entire nipple-areolar complex.
OBJECTIVES


The aim of the present study was to investigate the efficacy of combining the pecto-intercostal fascial block (PIFB) and Pecs II block for perioperative analgesia following modified radical mastectomy (MRM).
STUDY DESIGN


A prospective randomized study.
SETTING


An academic medical center.
METHODS


Sixty women undergoing unilateral MRM were randomly divided into 2 groups. The Pecs II group received Pecs II block using 20 mL bupivacaine 0.25% between the serratus anterior and the external intercostal muscles, and 10 mL bupivacaine 0.25% between the pectoralis major and minor muscles, together with sham PIFB using 15 mL normal saline solution in the interfascial plane between the pectoralis major muscle and the external intercostal muscle. PIFB-Pecs II group received the same Pecs II block combined with PIFB using 15 mL bupivacaine 0.25%.
RESULTS


The median (interquartile range [IQR]) time to the first morphine dose was significantly longer in the PIFB-Pecs II group (327.5 [266.3-360.0] minutes) than the Pecs II group (196 [163.8-248.8] minutes) (P < 0.001, 95% confidence interval [CI] 79.98, 150.00).The median (IQR) cumulative morphine consumption was higher in the Pecs II group (14.0 [11.0-18.0] mg) than the PIFB-Pecs II group (8.0 [7.0-9.0] mg) (P < 0.001; CI, 4.0-8.0). Intraoperative consumption of fentanyl was significantly lower in PIFB-Pecs II group with a median (IQR) of 0 (0-15 mu g) than the Pecs II group median 57.5 (0-75 mu g) (P = 0.022, CI; 0-60). The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001). The dermatomal block on the lateral chest wall was comparable between the 2 studied groups. PIFB-Pecs II provided extensive sensory block on the anterior chest wall, whereas Pecs II block failed to achieve any sensory block.
LIMITATIONS


This study was limited by its small sample size.
CONCLUSIONS


The combination of Pecs II and PIFB provide better perioperative analgesia for MRM than Pecs II alone.",2020,The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001).,"['An academic medical center', 'Modified Radical Mastectomy', 'Sixty women undergoing unilateral MRM']","['bupivacaine', 'modified radical mastectomy (MRM', 'bupivacaine 0.25% between the pectoralis major and minor muscles, together with sham PIFB using 15 mL normal saline solution', 'PIFB-Pecs II provided extensive sensory block', 'Pecto-Intercostal Fascial Block Combined with Pectoral Nerve Block', 'pecto-intercostal fascial block (PIFB) and Pecs II block']","['Visual Analog Scale scores', 'median (interquartile range [IQR]) time', 'median (IQR) cumulative morphine consumption', 'Intraoperative consumption of fentanyl']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",60.0,0.0509106,The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001).,"[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Abu Elyazed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shaimaa F', 'Initials': 'SF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Pain physician,[]
2074,32967392,"The Efficacy of Scrambler Therapy for the Management of Head, Neck and Thoracic Cancer Pain: A Randomized Controlled Trial.","BACKGROUND


Pain is still a common feature in all types of cancers including head and neck and thoracic cancer. Neuromodulatory techniques have gained popularity over opioids in recent times because of the risks associated with chronic opioid therapy. There are no clinical trials evaluating the efficacy of scrambler therapy (ST) for the management of pain due to head and neck and thoracic cancer.
OBJECTIVE


This trial was undertaken to evaluate the efficacy of scrambler therapy (ST) for pain relief and to assess the possible effect of ST on the dosage of opioids in patients suffering from cancer pain.
STUDY DESIGN


A randomized control trial (RCT) was performed.
SETTING


The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India.
METHOD


Forty patients were included in each of the 2 arms, control and Intervention. In both arms, patients were given pain management drugs. In the intervention group, patients additionally received 10 consecutive sessions of ST with one follow-up after 7 days. A numeric rating scale (NRS-11) was used to measure pain. Drug dosage was also recorded.
RESULTS


Overall, pain decreased in both arms. However, pain decreased more in the intervention arm as compared to the control arm. The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively. Differences between pain scores in both arms became significant from day 3 onwards. Mean morphine dose was significantly lower in the intervention arm from day 7 onwards.
LIMITATIONS


The study followed the patients until one week after the last treatment session and encouraged patients to return for treatment if their pain returned to previous levels within 10 days. Moreover, patients in the control arm received the standard of care in the form of pharmacological treatment but did not receive either transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure.
CONCLUSIONS


The trial showed that ST is an effective treatment for the management of pain due to head and neck and thoracic cancer. On the basis of this study, the use of ST for the management of refractory cancer pain in head and neck and thoracic cancer is recommended.",2020,"The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively.","['Head, Neck and Thoracic Cancer Pain', 'The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India', 'refractory cancer pain in head and neck and thoracic cancer', 'patients suffering from cancer pain', 'Forty patients were included in each of the 2 arms, control and Intervention']","['ST', 'transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure', 'scrambler therapy (ST', 'Scrambler Therapy']","['numeric rating scale (NRS-11', 'Mean morphine dose', 'Overall, pain', 'pain scores', 'pain']","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0153661', 'cui_str': 'Malignant neoplasm of thorax'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",40.0,0.0368248,"The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively.","[{'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kashyap', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sada Nand', 'Initials': 'SN', 'LastName': 'Dwivedi', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}]",Pain physician,[]
2075,32967393,Ashi Acupuncture Versus Local Anesthetic Trigger Point Injections in the Treatment of Abdominal Myofascial Pain Syndrome: A Randomized Clinical Trial.,"BACKGROUND


Chronic pelvic pain (CPP) is defined as recurrent or continuous pain in the lower abdomen or pelvis, non-menstrual or non-cyclic, lasting at least 6 months. There is strong evidence that up to 85% of patients with CPP have serious dysfunction of the musculoskeletal system, including abdominal myofascial syndrome (AMPS). AMPS is characterized as deep abdominal pain, originating from hyperirritable trigger points, usually located within a musculoskeletal range or its fascia of coating. In the literature, there are few studies that address AMPS.
OBJECTIVE


This study aimed to compare the responses of ashi acupuncture treatment and local anesthetic injection in the treatment of chronic pelvic pain secondary to abdominal myofascial pain syndrome in women.
STUDY DESIGN


Randomized controlled clinical trial.
SETTING


Tertiary University Hospital.
METHODS


Women with a clinical diagnosis of CPP secondary to AMPS were randomized and evaluated using instruments to assess clinical pain, namely, the visual analogue scale (VAS), numerical categorial scale (NCS), and the McGill Questionnaire, after receiving treatment with ashi acupuncture (group A, n = 16) or local anesthetic injections (group B, n = 19). They were reevaluated after one week and one, 3, and 6 months after each treatment, in addition to assessments of pain and adverse events performed during the sessions.
RESULTS


Ashi acupuncture and local anesthetic injections were both effective in reducing clinical pain assessed through the analyzed variables among study participants. There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
LIMITATIONS


The absence of blinding to the different forms of treatment among the patients and the researcher directly involved in the treatment, the absence of a placebo group, the selective exclusion of women with comorbidities and other causes of CPP, and the difference between the number of sessions used for each technique.
CONCLUSION


Treatments with ashi acupuncture and local anesthetic injections were effective in reducing clinical pain in women with abdominal myofascial pain syndrome.",2020,"There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
","['Abdominal Myofascial Pain Syndrome', 'chronic pelvic pain secondary to abdominal myofascial pain syndrome in women', 'Women with a clinical diagnosis of CPP secondary to AMPS', 'Tertiary University Hospital', 'women with abdominal myofascial pain syndrome']","['Acupuncture Versus Local Anesthetic Trigger Point Injections', 'acupuncture treatment and local anesthetic injection', 'acupuncture and local anesthetic injections', 'ashi acupuncture', 'local anesthetic injections']","['clinical pain, namely, the visual analogue scale (VAS), numerical categorial scale (NCS', 'pain and adverse events', 'clinical pain']","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.156752,"There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
","[{'ForeName': 'Andreia Moreira de Souza', 'Initials': 'AMS', 'LastName': 'Mitidieri', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Maria Carolina Dalla Vecchia', 'Initials': 'MCDV', 'LastName': 'Baltazar', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Ana Paula Moreira', 'Initials': 'APM', 'LastName': 'da Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Maria Beatriz Ferreira', 'Initials': 'MBF', 'LastName': 'Gurian', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Omero Benedicto', 'Initials': 'OB', 'LastName': 'Poli-Neto', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Candido-Dos-Reis', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Antonio Alberto', 'Initials': 'AA', 'LastName': 'Nogueira', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Julio Cesar', 'Initials': 'JC', 'LastName': 'Rosa-E-Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}]",Pain physician,[]
2076,32973176,Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer.,"Pre-clinical models have shown that targeting pancreatic stellate cells with all-trans-retinoic-acid (ATRA) reprograms pancreatic stroma to suppress pancreatic ductal adenocarcinoma (PDAC) growth. Here, in a phase Ib, dose escalation and expansion, trial for patients with advanced, unresectable PDAC (n = 27), ATRA is re-purposed as a stromal-targeting agent in combination with gemcitabine-nab-paclitaxel chemotherapy using a two-step adaptive continual re-assessment method trial design. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D, primary outcome) is the FDA/EMEA approved dose of gemcitabine-nab-paclitaxel along-with ATRA (45 mg/m 2  orally, days 1-15/cycle). Dose limiting toxicity (DLT) is grade 4 thrombocytopenia (n = 2). Secondary outcomes show no detriment to ATRA pharmacokinetics.. Median overall survival for RP2D treated evaluable population, is 11.7 months (95%CI 8.6-15.7 m, n = 15, locally advanced (2) and metastatic (13)). Exploratory pharmacodynamics studies including changes in diffusion-weighted (DW)-MRI measured apparent diffusion coefficient after one cycle, and, modulation of cycle-specific serum pentraxin 3 levels over various cycles indicate stromal modulation. Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable. This combination will be evaluated in a phase II randomized controlled trial for locally advanced PDAC. Clinical trial numbers: EudraCT: 2015-002662-23; NCT03307148. Trial acronym: STARPAC.",2020,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","['pancreatic cancer', 'patients with advanced, unresectable PDAC (n\u2009=\u200927), ATRA is re-purposed as a stromal-targeting agent in combination with']","['ATRA', 'gemcitabine-nab-paclitaxel chemotherapy', 'trans retinoic acid', 'gemcitabine-nab-paclitaxel']","['ATRA pharmacokinetics', 'Median overall survival']","[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.113681,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","[{'ForeName': 'Hemant M', 'Initials': 'HM', 'LastName': 'Kocher', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK. h.kocher@qmul.ac.uk.'}, {'ForeName': 'Bristi', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Department of Oncology, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Fieke E M', 'Initials': 'FEM', 'LastName': 'Froeling', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London-Hammersmith Hospital, London, W12 0HS, UK.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, Guy's Hospital Campus, London, SE1 9RT, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Slater', 'Affiliation': 'Barts and the London HPB Centre, The Royal London Hospital, Barts Health NHS Trust, Whitechapel, London, E1 1FR, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Carlin', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Nandita M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Katja N', 'Initials': 'KN', 'LastName': 'De Paepe', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Goulart', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Imrali', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pawula', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Houghton', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Yathushan', 'Initials': 'Y', 'LastName': 'Yogeswaran', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mousa', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Carike', 'Initials': 'C', 'LastName': 'Coetzee', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': 'Cancer Prevention Trials Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Propper', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}]",Nature communications,['10.1038/s41467-020-18636-w']
2077,32959502,Plasma D-dimer concentrations predicting stroke risk and rivaroxaban benefit in patients with heart failure and sinus rhythm: an analysis from the COMMANDER-HF trial.,"AIMS


D-dimer is a marker of fibrin degradation that reflects intravascular coagulation. Therefore, plasma concentrations of D-dimer might predict thromboembolic risk and rivaroxaban treatment effect. The aims of this study were to investigate the association between D-dimer levels and the risk of stroke and other thrombotic, bleeding and fatal events, and whether D-dimer concentrations could predict rivaroxaban 2.5 mg twice daily (vs. placebo) effect in patients enrolled in the COMMANDER-HF trial who were in sinus rhythm, had heart failure with reduced ejection fraction and coronary artery disease.
METHODS AND RESULTS


Survival models with treatment-by-plasma D-dimer interaction. Baseline measurement of D-dimer was available in 4107 (82%) of 5022 patients enrolled. Median (percentile 25-75  ) follow-up was 21 (12.9-32.8) months. The median (percentile 25-75  ) plasma concentration of D-dimer was 360 (215-665) ng/mL. The D-dimer tertiles were: (i) ≤255 ng/mL; (ii) 256-515 ng/mL; and (iii) >515 ng/mL. Patients within the tertile 3 were older, and had lower body mass index, blood pressure, haemoglobin, estimated glomerular filtration rate, and left ventricular ejection fraction. Higher plasma D-dimer concentrations were independently associated with higher rates of death, stroke, and venous thromboembolism. For example, the all-cause death adjusted hazard ratio (HR) (95%CI) of tertile 3 vs. tertile 1 was 1.77 [95% confidence interval (CI) 1.48-2.11; P < 0.001]. The effect of rivaroxaban was similar in each tertile of D-dimer for all outcomes except stroke. Patients within the tertile 3 had the greatest absolute and relative stroke reduction (tertile 1: HR 1.16, 95% CI 0.49-2.74; tertile 2: HR 1.45, 95% CI 0.77-2.73; tertile 3: HR 0.36, 95% CI 0.18-0.70; P for interaction = 0.008). The number-needed-to-treat to prevent one stroke in tertile 3 was 36.
CONCLUSIONS


In COMMANDER-HF, rivaroxaban reduced the risk of stroke but the benefit may be confined to patients with D-dimer concentrations above 515 ng/mL. Prospective trials are warranted to confirm these findings.",2020,"515ng/mL. Patients within the tertile-3 were older, and had lower BMI, blood pressure, hemoglobin, eGFR, and LVEF.","['Survival models with treatment-by-plasma D-dimer interaction', 'patients with heart failure and sinus rhythm', 'patients enrolled in the COMMANDER-HF trial who were in sinus rhythm, had HFrEF and coronary artery disease', '5,022 patients enrolled']","['rivaroxaban', 'placebo']","['relative stroke reduction', 'Higher plasma D-dimer concentrations', 'lower BMI, blood pressure, hemoglobin, eGFR, and LVEF', 'death, stroke, and venous thromboembolism']","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",5022.0,0.278366,"515ng/mL. Patients within the tertile-3 were older, and had lower BMI, blood pressure, hemoglobin, eGFR, and LVEF.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France; CHRU de Nancy, Inserm U1116, Nancy, France; FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies, Berlin, Germany.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey, NJ, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'La Police', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey, NJ, USA.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France; CHRU de Nancy, Inserm U1116, Nancy, France; FCRIN INI-CRCT, Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.2003']
2078,32961507,The effects of acute work stress and appraisal on psychobiological stress responses in a group office environment.,"BACKGROUND


The high prevalence of office stress and its detrimental health consequences are of concern to individuals, employers and society at large. Laboratory studies investigating office stress have mostly relied on data from participants that were tested individually on abstract tasks. In this study, we examined the effect of psychosocial office stress and work interruptions on the psychobiological stress response in a realistic but controlled group office environment. We also explored the role of cognitive stress appraisal as an underlying mechanism mediating the relationship between work stressors and the stress response.
METHODS AND MATERIALS


Ninety participants (44 female; mean age 23.11 ± 3.80) were randomly assigned to either a control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting. To induce psychosocial stress, we adapted the Trier Social Stress Test for Groups to an office environment. Throughout the experiment, we continuously monitored heart rate and heart rate variability. Participants repeatedly reported on their current mood, calmness, wakefulness and perceived stress and gave saliva samples to assess changes in salivary cortisol and salivary alpha-amylase. Additionally, cognitive appraisal of the psychosocial stress test was evaluated.
RESULTS


Our analyses revealed significant group differences for most outcomes during or immediately after the stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate). Interestingly, the condition that experienced work interruptions showed a higher increase of cortisol levels but appraised the stress test as less threatening than individuals that experienced only psychosocial stress. Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
DISCUSSION


The results showed that experimentally induced work stress led to significant responses of subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. However, there appears to be a discrepancy between the psychological and biological responses to preceding work interruptions. Appraising psychosocial stress as less threatening but still as challenging could be an adaptive way of coping and reflect a state of engagement and eustress.",2020,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
",['Ninety participants (44 female; mean age 23.11 ± 3.80'],['control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting'],"['heart rate and heart rate variability', 'stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate', 'psychobiological stress responses', 'psychobiological stress response', 'subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system', 'cortisol levels', 'current mood, calmness, wakefulness and perceived stress and gave saliva samples', 'salivary cortisol and salivary alpha-amylase']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",90.0,0.0154888,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
","[{'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Kerr', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland. Electronic address: jkerr@ethz.ch.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Naegelin', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Weibel', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrario', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Marca', 'Affiliation': 'Chair of Clinical Psychology and Psychotherapy, Department of Psychology, University of Zurich, Binzmuehlestrasse 14, 8050 Zurich, Switzerland; Clinica Holistica Engiadina, Plaz 40, 7542 Susch, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Wangenheim', 'Affiliation': 'Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoelscher', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland.'}, {'ForeName': 'Victor R', 'Initials': 'VR', 'LastName': 'Schinazi', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland; Department of Psychology, Bond University, 14 University Drive, Robina Queensland 4226, Australia.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104837']
2079,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS


Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS


This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS


The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION


Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
2080,32962487,Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone for exudative age-related macular degeneration.,"OBJECTIVE


To compare the efficacy of ranibizumab plus fufang xueshuantong capsule (cFXST) with the efficacy of ranibizumab alone in treatment of exudative age-related macular degeneration.
METHODS


This prospective, randomized, controlled, pilot study included 38 eyes from 38 patients with exudative age-related macular degeneration (AMD) that were randomly allocated into two cohorts of 19 eyes each: ranibizumab (C r ) and ranibizumab plus cFXST (C fr ). All patients received three monthly injections of ranibizumab. Patients in C fr  also received daily oral supplementation of cFXST. Best corrected visual acuity (BCVA) and thickness of the choroidal neovascularization-pigment epithelial detachment (CNV-PED) complex (measured by optical coherence tomography) were recorded at baseline and at 1 and 3 months after the first intravitreal injection of ranibizumab.
RESULTS


In the C fr , the CNV-PED complex thickness was reduced by 31.7% and 36.1% at 1 and 3 months, respectively; these reductions were significantly greater than the 19.7% and 24.2% reductions in the C r . BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
CONCLUSION


Oral cFXST increases the efficacy of short-term ranibizumab treatment for exudative AMD.",2020,"BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
","['38 eyes from 38 patients with exudative age-related macular degeneration (AMD', 'exudative age-related macular degeneration', 'exudative AMD']","['ranibizumab (C r ) and ranibizumab plus cFXST (C fr ', 'Oral cFXST', 'ranibizumab plus fufang xueshuantong capsule (cFXST', 'Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone', 'daily oral supplementation of cFXST', 'ranibizumab alone', 'ranibizumab']","['BCVA improvement', 'Best corrected visual acuity (BCVA) and thickness of the choroidal neovascularization-pigment epithelial detachment (CNV-PED) complex', 'CNV-PED complex thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",38.0,0.072237,"BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
","[{'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Pan', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Long', 'Initials': 'JL', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yuan-Lu', 'Initials': 'YL', 'LastName': 'Shuai', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zi-Zhong', 'Initials': 'ZZ', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yu-Zhi', 'Initials': 'YZ', 'LastName': 'Ding', 'Affiliation': 'Department of Ophthalmology, Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Qing-Huai', 'Initials': 'QH', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}]",The Journal of international medical research,['10.1177/0300060520931618']
2081,32962724,A whole family-based physical activity promotion intervention: findings from the families reporting every step to health (FRESH) pilot randomised controlled trial.,"INTRODUCTION


This study assessed the feasibility and acceptability of FRESH (Families Reporting Every Step to Health), a theory-based child-led family physical activity (PA) intervention delivered online. We also assessed the preliminary effectiveness of the intervention on outcomes of interest and whether pre-specified criteria were met to progress to a full-scale definitive trial.
METHODS


In a three-armed randomised pilot trial, 41 families (with a 7-11-year-old index child) were allocated to a: 'family' (FAM), 'pedometer-only' (PED), or a no-treatment control (CON) arm. The FAM arm received access to the FRESH website, allowing participants to select step challenges to 'travel' to target cities around the world, log their steps, and track progress as families virtually globetrot. FAM and PED arms also received family sets of pedometers. All family members could participate in the evaluation. Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), behavioural (e.g., objectively-measured PA), and economic (e.g., expenditure for PA) data were collected at baseline, 8- and 52-weeks.
RESULTS


At 8- and 52-weeks, 98 and 88% of families were retained, respectively. Most children liked participating in the study (> 90%) and thought it was fun (> 80%). Compared to the PED (45%) and CON (39%) arms, a higher percentage of children in the FAM (81%) arm reported doing more activities with their family. Adults agreed that FRESH encouraged their family do more PA and made their family more aware of the amount of PA they do. No notable between-group differences were found for childrens' minutes in moderate-to-vigorous PA. Sizeable changes of 9.4 (95%CI: 0.4, 18.4) and 15.3 (95%CI: 6.0, 24.5) minutes in moderate-to-vigorous PA was found for adults in the FAM group compared to those in the PED or CON groups, respectively. No other notable differences were found.
CONCLUSION


This study demonstrates feasibility and acceptability of the FRESH intervention. All progression criteria were at least partially satisfied. However, we failed to recruit the target sample size and did not find a signal of effectiveness on PA particularly long-term or in children. Further refinements are required to progress to a full-scale trial.
TRIAL REGISTRATION


This study was prospectively registered ( ISRCTN12789422 ) on 16/03/2016.",2020,Most children liked participating in the study (> 90%) and thought it was fun (> 80%).,['41 families (with a 7-11-year-old index child'],"[""family' (FAM), 'pedometer-only' (PED), or a no-treatment control (CON"", 'FRESH', 'A whole family-based physical activity promotion intervention', 'FRESH intervention']","['Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), behavioural (e.g., objectively-measured PA), and economic (e.g., expenditure for PA) data']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",41.0,0.0421623,Most children liked participating in the study (> 90%) and thought it was fun (> 80%).,"[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Guagliano', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK. Justin.Guagliano@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Armitage', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Coombes', 'Affiliation': 'Norwich Medical School and Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fusco', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Norwich Medical School and Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Morton', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01025-3']
2082,32969535,Adaptation to a ketogenic diet modulates adaptive and mucosal immune markers in trained male endurance athletes.,"This study examined the effect of short-term adaptation to a ketogenic diet (KD) on resting and post-exercise immune markers. Using a randomized, repeated-measures, crossover design, eight trained, male, endurance athletes ingested a 31-day low carbohydrate (CHO), KD (energy intake: 4% CHO; 78% fat) or their habitual diet (HD) (energy intake: 43% CHO; 38% fat). On days 0 and 31, participants ran to exhaustion at 70% VO 2max  . A high-CHO (2 g·kg -1  ) meal was ingested prior to the pre-HD, post-HD, and pre-KD trials, with CHO (~55 g·h -1  ) ingested during exercise, whereas a low-CHO (<10 g) meal was ingested prior to the post-KD trial, with fat ingested during exercise. Blood and saliva samples were collected at pre-exercise, exhaustion, and 1 hour post-exhaustion. T-cell-related cytokine gene expression within peripheral blood mononuclear cells (PBMCs) and whole-blood inflammatory cytokine production were determined using 24-hour multi-antigen-stimulated whole-blood cultures. Multi-antigen-stimulated PBMC IFN-γ mRNA expression and the IFN-γ/IL-4 mRNA expression ratio were higher at exhaustion in the post-KD compared with pre-KD trial (P = 0.003 and P = 0.004); however, IL-4 and IL-10 mRNA expression were unaltered (P > 0.05). Multi-antigen-stimulated whole-blood IL-10 production was higher in the post-KD compared with pre-KD trial (P = 0.028), whereas IL-1β, IL-2, IL-8, and IFN-γ production was lower in the post-HD compared with pre-HD trial (P < 0.01). Salivary immunoglobulin A (SIgA) secretion rate was higher in the post-KD compared with pre-KD trial (P < 0.001). In conclusion, short-term adaptation to a KD in endurance athletes may alter the pro- and anti-inflammatory immune cell cytokine response to a multi-antigen in vitro and SIgA secretion rate.",2020,"Multi-antigen-stimulated whole-blood IL-10 production was higher in the post- compared with pre-KD trial (p=0.028); whereas, IL-1β, IL-2, IL-8 and IFN-γ production were lower in the post- compared with pre-HD trial (p<0.01).",['trained male endurance athletes'],"['short-term adaptation to a ketogenic diet (KD', 'endurance athletes ingested a 31-day low-carbohydrate (CHO), KD (energy intake: 4% CHO; 78% fat) or their habitual diet (HD', 'ketogenic diet']","['Salivary immunoglobulin A (SIgA) secretion rate', 'IL-4 and IL-10 mRNA expression', 'IL-1β, IL-2, IL-8 and IFN-γ production', 'blood IL-10 production', 'T-cell-related cytokine gene expression within peripheral blood mononuclear cells (PBMC) and whole-blood inflammatory cytokine production', 'IFN-γ/IL-4 mRNA expression ratio', 'Blood and saliva samples']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]","[{'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0371888,"Multi-antigen-stimulated whole-blood IL-10 production was higher in the post- compared with pre-KD trial (p=0.028); whereas, IL-1β, IL-2, IL-8 and IFN-γ production were lower in the post- compared with pre-HD trial (p<0.01).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shaw', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Merien', 'Affiliation': 'AUT Roche Diagnostics Laboratory, School of Science, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Braakhuis', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Keaney', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Dulson', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13833']
2083,32966832,Rapid reduction in plaque inflammation by sonodynamic therapy inpatients with symptomatic femoropopliteal peripheral artery disease:A randomized controlled trial.,"BACKGROUND


Inflammation is actively involved in the clinical manifestation of peripheral artery disease (PAD). Sonodynamic therapy (SDT), a novel non-invasive, plaque-based, macrophage-targeted anti-inflammatory regimen for atherosclerosis has the potential to improve walking performance by reducing plaque inflammation.
METHODS


This phase-2, randomized, sham-controlled, double-blind clinical trial enrolled 32 participants with symptomatic femoropopliteal PAD. The primary outcome was the 30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT). The secondary outcomes were changes in walking performance, limb perfusion, lesional morphology and quality of life measurements.
RESULTS


The mean age was 64.7 years and 63% were male. Thirty-one completed follow-up. SDT significantly decreased the MDS TBR by 0.53 (95% CI, -0.70 to -0.36, P < 0.001) compared with control. Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P < 0.001) and 9.6% (95% CI, -24.5 to -5.3, P = 0.005), respectively, and increased the walking speed score of the Walking Impairment Questionnaire by 16.1 (95% CI, 2.6 to 29.5, P = 0.021) and the physical functioning score of the 36-item Short-Form Health Survey by 10.0 (95% CI, 5.0 to 20.0, P = 0.003) compared with control. These improvements were maintained in the SDT group up to 6-month.
CONCLUSIONS


SDT rapidly reduced plaque inflammation and improved walking performance among patients with symptomatic PAD.
TRIAL REGISTRATION


Clinical Trials NCT03457662.",2020,"Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P ","['32 participants with symptomatic femoropopliteal PAD', 'patients with symptomatic PAD', 'The mean age was 64.7\u202fyears and 63% were male', 'patients with symptomatic femoropopliteal peripheral artery disease']","['Sonodynamic therapy (SDT', 'sonodynamic therapy']","['walking speed score of the Walking Impairment Questionnaire', 'plaque inflammation', 'changes in walking performance, limb perfusion, lesional morphology and quality of life measurements', 'MDS TBR', 'lesional diameter and area stenosis', '30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT', 'physical functioning score of the 36-item Short-Form Health Survey', 'plaque inflammation and improved walking performance', 'ankle-brachial index', 'peak walking time']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0190886', 'cui_str': 'Perfusion of limb'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",32.0,0.373441,"Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P ","[{'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Jingxue', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of PET/CT, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, PR China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Jiemei', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Mengjiao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of PET/CT, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, PR China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Qiannan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Bicheng', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Haiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Photo- and Sono-theranostic Technologies and Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, PR China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Pathophysiology and Key Laboratory of Cardiovascular Pathophysiology, Harbin Medical University, Key Laboratory of Cardiovascular Medicine Research (Harbin Medical University), Ministry of Education, Harbin, PR China. Electronic address: yetian@ems.hrbmu.edu.cn.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.035']
2084,32966877,Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.,"BACKGROUND


The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.
METHOD


To investigate the ""real-world"" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
RESULTS


The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.
CONCLUSIONS


This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.",2020,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","['US smokers', 'California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1', '359 participants (average age 39\u202fyears; average cigarette consumption half a pack/day']","['Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack', 'Real-world exposure to graphic warning labels', 'repackaging cigarettes from standard US packs to GWL plain packs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],359.0,0.0172592,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: jppierce@ucsd.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Stone', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: m3stone@ucsd.edu.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: adriana.villasenor@sdcounty.ca.gov.'}, {'ForeName': 'Claudiu V', 'Initials': 'CV', 'LastName': 'Dimofte', 'Affiliation': 'Department of Marketing, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, United States. Electronic address: cdimofte@sdsu.edu.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leas', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ecleas@ucsd.edu.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Oratowski', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: joratowski@ucsd.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brighton', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ebrighton@ucsd.edu.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States. Electronic address: shurst@ucsd.edu.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, Social and Behavioral Sciences Building, California State University, San Marcos 200 E Barham Dr, San Marcos, CA, 92096, United States. Electronic address: kpulvers@csusm.edu.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kealey', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ruc075@ucsd.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Messer', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: kmesser@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106152']
2085,32966919,"Effects of vitamin D supplementation on core symptoms, serum serotonin, and interleukin-6 in children with autism spectrum disorders: A randomized clinical trial.","OBJECTIVES


Children with autism spectrum disorders (ASD) have lower serum vitamin D and higher serotonin and interleukin (IL)-6 levels compared with healthy children. The aim of this study was to evaluate the effect of vitamin D on core symptoms and serum levels of serotonin and IL-6 in these children.
METHODS


This parallel randomized double-blind, placebo-controlled trial was conducted with 43 children with ASD (7 girls and 36 boys; 8.91 ± 2.87 y of age). Children were randomly allocated to receive either vitamin D drop (300 IU/kg up to a maximum of 6000 IU daily) or placebo for 15 wk. Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin were measured at baseline and at the end of the trial. Also, the severity of autism and the social and individual maturity of the children were measured by the Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires before and after intervention. Randomization and allocation to groups were done using computer-generated numbers.
RESULTS


More than 86% of patients had vitamin D deficiency at the beginning of the study. Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001). The clinical symptoms of autism measured by CARS and ATEC scales were alleviated significantly (P = 0.021 and P = 0.020, respectively); however, the serum levels of serotonin and IL-6 and the scale of ABC-C remained without a significant change.
CONCLUSION


These findings suggest that vitamin D supplementation may improve ASD symptoms; however, more studies with longer duration are indispensable to confirm our results.",2020,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"['43 children with ASD (7 girls and 36 boys; 8.91 ±', 'children with autism spectrum disorders', 'Children with autism spectrum disorders (ASD']","['vitamin D supplementation', 'placebo', 'vitamin D']","['Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires', 'Serum levels of 25(OH)D', 'ASD symptoms', 'serum levels of serotonin and IL-6 and the scale of ABC-C', 'CARS and ATEC scales', 'core symptoms, serum serotonin, and interleukin-6', 'serum vitamin D and higher serotonin and interleukin (IL)-6 levels', 'vitamin D deficiency', 'Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]",43.0,0.328924,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Javadfar', 'Affiliation': 'Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran; Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: hadi_nut@yahoo.com.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Amirian', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Goharmehr', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110986']
2086,32967873,Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands.,"INTRODUCTION


Delirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
METHODS AND ANALYSIS


EuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.
ETHICS AND DISSEMINATION


The study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.
TRIAL REGISTRATION


NCT03628391.",2020,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","['adult Critically ill patiEnts (EuRIDICE', 'adult critically ill patients to reduce days spent with coma or delirium', 'Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment']","['halopeRIdol', 'haloperidol 2.5\u2009mg (or matching placebo', 'placebo', 'haloperidol']","['burden of Delirium', 'DCFDs', 'efficacy and safety', 'delirium and coma-free days (DCFD', '1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.593027,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smit', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Trogrlić', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Northeastern University Bouve College of Health Sciences, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Osse', 'Affiliation': 'Department of Psychiatry, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Huibert H', 'Initials': 'HH', 'LastName': 'Ponssen', 'Affiliation': 'Department of Intensive Care, Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Centre Utrecht Brain Centre, Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Nicole G M', 'Initials': 'NGM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Pharmacy and Department of Intensive Care Adults, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Wim J R', 'Initials': 'WJR', 'LastName': 'Rietdijk', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Gommers', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'van der Jagt', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands m.vanderjagt@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036735']
2087,32967874,"Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial.","INTRODUCTION


Communication is an essential aspect of care for patients with progressive serious illnesses. This study aims to evaluate the efficacy of a new, integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers.
METHODS AND ANALYSIS


The proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospitals in a metropolitan area in Japan. A total of 20 oncologists, 200 patients with advanced pancreatic cancer and the patients' caregivers are enrolled in this study as of the writing of this protocol report. Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients and caregivers are allocated to the same group as their oncologists. The IG oncologists receive a 2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training. Follow-up data will be collected quarterly for 6 months for a year and then annually for up to 3 years. The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
ETHICS AND DISSEMINATION


This study is conducted in accordance with the ethical guidelines for clinical studies published by Japan's Ministry of Education, Cultural, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of National Cancer Center, Japan on 4 July 2018 (ID: 2017-474).
TRIAL STATUS


This study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trial Registry (UMIN000033612); pre-results.",2020,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","['patients with rapidly progressing advanced cancer and their caregivers', 'oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication', ""200 patients with advanced pancreatic cancer and the patients' caregivers"", 'comprehensive cancer centre hospitals in a metropolitan area in Japan', 'patients with progressive serious illnesses']","['2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training', 'integrated communication support program', 'Integrated communication support program', 'intervention group (IG) or control group (CG']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],200.0,0.0842864,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","[{'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan mfujimor@ncc.go.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Jinno', 'Affiliation': 'Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Chuo-ku, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine Department of Medical Biochemistry, Sendai, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary Pancreatic Oncology, National Cancer Center-Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ozaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Medical Oncology, Public Interest Incorporated Foundation Cancer Institute Hospital of JFCR, Koto-ku, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Takayama', 'Affiliation': ""Department of Medicine, Institute of Gastroenterology, Tokyo Women's Medical University Hospital, Shinjuku-ku, Japan.""}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Bunkyo-ku, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Majima', 'Affiliation': 'President, Pancreatic Cancer Action Network, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036745']
2088,32967877,Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking. Given the substantial impact of SDNS/FRNS on quality of life, strategies aiming to provide long-term remission while minimising treatment side effects are needed. Several studies confirm that rituximab is effective in preventing early relapses in SDNS/FRNS; however, the long-term relapse rate remains high (~70% at 2 years). This trial will assess the association of intravenous immunoglobulins (IVIgs) to rituximab in patients with SDNS/FRNS and inform clinicians on whether IVIg's immunomodulatory properties can alter the course of the disease and reduce the use of immunosuppressive drugs and their side effects.
METHODS AND ANALYSIS


We conduct an open-label multicentre, randomised, parallel group in a 1:1 ratio, controlled, superiority trial to assess the safety and efficacy of a single infusion of rituximab followed by IVIg compared with rituximab alone in childhood-onset FRNS/SDNS. The primary outcome is the occurrence of first relapse within 24 months. Patients are allocated to receive either rituximab alone (375 mg/m²) or rituximab followed by IVIg, which includes an initial Ig dose of 2 g/kg, followed by 1.5 g/kg injections once a month for the following 5 months (maximum dose: 100 g).
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee (Comité de Protection des Personnes) of Ouest I and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03560011.",2020,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","['patients with SDNS/FRNS', 'childhood-onset FRNS/SDNS', 'childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome']","['SDNS/FRNS', 'intravenous immunoglobulin with rituximab versus rituximab alone', 'rituximab', 'intravenous immunoglobulins (IVIgs) to rituximab', 'rituximab alone']","['Efficacy and safety', 'safety and efficacy', 'occurrence of first relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.194947,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France julien.hogan@aphp.fr.'}, {'ForeName': 'Aubriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Surgery, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Sellier-Leclerc', 'Affiliation': 'Department of Pediatric Nephrology, Hôpital Femme Mère Enfant, Bron, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vrillon', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Broux', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Rouen, Rouen, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Besancon, Besancon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Harambat', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Bordeaux Groupe hospitalier Pellegrin, Bordeaux, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Bessenay', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Audard', 'Affiliation': 'Department of Nephrology and Transplantation, Henri Mondor Hospital, APHP, Université Paris-Est, Créteil, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faudeux', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Morin', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pietrement', 'Affiliation': ""Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Reims Hôpital d'enfants, Reims, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tellier', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Eckart', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lahoche', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Lille, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roussey-Kesler', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ulinski', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Trousseau la Roche-Guyon, Paris, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Boyer', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Plaisier', 'Affiliation': 'Department of Nephrology, Hopital Tenon, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cloarec', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jolivot', 'Affiliation': 'Department of Nephrology, Groupement Hospitalier Edouard Herriot, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guigonis', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Limoges, Limoges, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guilmin-Crepon', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Baudouin', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dossier', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}]",BMJ open,['10.1136/bmjopen-2020-037306']
2089,32967883,Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol.,"INTRODUCTION


Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.
METHODS AND ANALYSIS


STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.
TRIAL REGISTRATION


The trial is registered on ClinicalTrials.gov (ID: NCT03548428).
ETHICS AND DISSEMINATION


This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.",2020,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","['et outre-mer 4 on 18 October 2019', 'oligometastatic sarcoma patients', 'oligometastatic soft tissue sarcomas']","['SBRT with atezolizumab and SBRT alone', 'immunomodulated stereotactic multisite irradiation', 'Cytotoxic therapy', 'SBRT', 'concomitant radiotherapy with atezolizumab', 'stereotactic body radiation therapy (SBRT']","['PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution', 'progression-free survival (PFS) rate']","[{'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0876936', 'cui_str': 'Mathematical Model'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",,0.112088,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'le Guevelou', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Debaigt', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Viotti', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Khalladi', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thibouw', 'Affiliation': 'Medical oncology department, Georges-Francois Leclerc Centre, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Medical oncology department, Centre Oscar Lambret, lille, France.'}, {'ForeName': 'Marie Pierre', 'Initials': 'MP', 'LastName': 'Sunyach', 'Affiliation': 'Centre Léon Bérard, Lyon, Rhône-Alpes, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': ""Paoli-Calmettes Institute, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Benchalal', 'Affiliation': 'Eugène Marquis Cancer Institute, Rennes, Bretagne, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Radiation oncology department, CHU Rouen Biochimie Médicale, Rouen, Haute-Normandie, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ducassou', 'Affiliation': 'Radiation oncology department, IUCT Oncopole, Toulouse, Languedoc-Roussillon-Midi, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'le Pechoux', 'Affiliation': 'Radiation oncology department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jolnerovski', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bazille', 'Affiliation': 'Biomolecular pathology department, CHU Caen, Caen, Basse-Normandie, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vaur', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Escande', 'Affiliation': 'Radiation oncology department, Oscar Lambret Cancer Centre, Lille, Hauts-de-France, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Serre', 'Affiliation': 'Radiation oncology department, CHU Limoges, Limoges, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lovera', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France jthariat@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038391']
2090,32977221,Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy.,"BACKGROUND


Limited evidence exists to support CA-125 as a valid surrogate biomarker for progression in patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy. We aimed to assess the concordance between CA-125 and Response Evaluation Criteria in Solid Tumours (RECIST) criteria for progression in patients with BRCA mutations on maintenance PARPi or placebo.
METHODS


We extracted data on progression as defined by Gynecologic Cancer InterGroup CA-125, investigator- and independent central-assessed RECIST from the SOLO2/ENGOT-ov21(NCT01874353) trial. We excluded those with progression other than by RECIST, progression on date of randomisation, and no repeat CA-125 beyond baseline. We evaluated the concordance between CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV).
RESULTS


Of 295 randomised patients, 275 (184 olaparib, 91 placebo) were included. 171 patients had investigator-assessed RECIST progression. Of 80 patients with CA-125 progression, 77 had concordant RECIST progression (PPV 96%, 95% confidence interval 90-99%). Of 195 patients without CA-125 progression, 94 had RECIST progression (NPV 52%, 45-59%). Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]). Of 94 patients with RECIST but without CA-125 progression, 64 (68%) had CA-125 that remained within normal range. We observed similar findings using independent-assessed RECIST.
CONCLUSIONS


Almost half the patients without CA-125 progression had RECIST progression, and most of these had CA-125 within the normal range. Regular computed tomography imaging should be considered as part of surveillance in patients treated with or without maintenance olaparib rather than relying on CA-125 alone.",2020,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","['patients with BRCA mutations on maintenance PARPi or placebo', 'patients treated with or without maintenance olaparib rather than relying on CA-125 alone', '295 randomised patients, 275 (184 olaparib, 91', 'patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy', '171 patients had investigator-assessed RECIST progression', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer']","['placebo', 'Regular computed tomography imaging']","['PPV', 'RECIST progression', 'CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV', 'concordant RECIST progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0729619', 'cui_str': 'Computed tomography imaging - action'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.112487,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia. Electronic address: angelina.tjokrowidjaja@ctc.usyd.edu.au.'}, {'ForeName': 'Chee K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, 31059 Toulouse, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, London WC1E 6DD, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Penson', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Korach', 'Affiliation': 'Gynecologic Oncology Department, Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, 52621 Tel Aviv, Israel.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Huzarski', 'Affiliation': 'Department of Genetics and Pathology, Pomeranian Medical University, 70-204 Szczecin, Poland.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Hospital 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pisano', 'Affiliation': 'Department of Urogynecology, National Cancer Institute, Pascale Foundation (Scientific Institute for Research and Healthcare), 80131 Naples, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; School of Medicine, The University of Notre Dame, Sydney, NSW 2007, Australia.'}, {'ForeName': 'Se Ik', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecology Program, European Institute of Oncology, IRCCS, 20141 Milan, Italy; School of Medicine and Surgery, University Milan Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, 30625 Hannover, Germany.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama 350-0495, Japan.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, 1066 CX Amsterdam, the Netherlands.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Oncology, KU Leuven - University of Leuven, B-3000 Leuven, Belgium; Division of Gynaecological Oncology, University Hospitals Leuven, B-3000 Leuven, Belgium.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Université Paris Descartes, Paris, France; ARCAGY-GINECO, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.021']
2091,32979249,COVID-19: Comparing the applicability of shared room and single room occupancy.,"To curb the COVID-19 pandemic, isolation measures are required. Shared room occupancy is recommended when isolation rooms are insufficient. However, there is little evidence of the applicability of shared and single room occupancy for patients with COVID-19 to determine whether shared room occupancy is feasible. COVID-19-infected patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 February 2020 to 20 April 2020 were enrolled in the study and randomly assigned to hospital rooms. Clinical symptoms, underlying diseases and epidemiological data of patients were analysed after dividing participants into a shared room occupancy group (group A) and a single room occupancy group (group B). Outcomes analysed included microbiological cure rates, time to clinical symptom improvement, time to defervescence and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization. A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively. Group B included more underlying conditions, such as pregnancy and solid organ transplantation, and was more closely associated with severe pneumonia during hospitalization. Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed. Our results suggest that the shared room occupancy of patients with mild symptoms could be an alternative to single room occupancy during the COVID-19 pandemic.",2020,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","['COVID-19 patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 st  February 2020 to 20 th  April 2020 were enrolled in the study and randomly assigned to hospital rooms', 'A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively']",['COVID-19'],"['clinical symptoms, and time to defervescence', 'negative PCR rates', 'microbiological cure rates, time to clinical symptom improvement, time to defervescence, and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",666.0,0.034077,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Hyun', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Yong Shik', 'Initials': 'YS', 'LastName': 'Kwon', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Radiology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Sunggyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Ryoo', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyun Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}]",Transboundary and emerging diseases,['10.1111/tbed.13853']
2092,32966722,"Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial.","BACKGROUND


The World Health Organization recommends 20 mg of zinc per day for 10 to 14 days for children with acute diarrhea; in previous trials, this dosage decreased diarrhea but increased vomiting.
METHODS


We randomly assigned 4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea to receive 5 mg, 10 mg, or 20 mg of zinc sulfate for 14 days. The three primary outcomes were a diarrhea duration of more than 5 days and the number of stools (assessed in a noninferiority analysis) and the occurrence of vomiting (assessed in a superiority analysis) within 30 minutes after zinc administration.
RESULTS


The percentage of children with diarrhea for more than 5 days was 6.5% in the 20-mg group, 7.7% in the 10-mg group, and 7.2% in the 5-mg group. The difference between the 20-mg and 10-mg groups was 1.2 percentage points (upper boundary of the 98.75% confidence interval [CI], 3.3), and that between the 20-mg and 5-mg groups was 0.7 percentage points (upper boundary of the 98.75% CI, 2.8), both of which were below the noninferiority margin of 4 percentage points. The mean number of diarrheal stools was 10.7 in the 20-mg group, 10.9 in the 10-mg group, and 10.8 in 5-mg group. The difference between the 20-mg and 10-mg groups was 0.3 stools (upper boundary of the 98.75% CI, 1.0), and that between the 20-mg and 5-mg groups was 0.1 stools (upper boundary of the 98.75% CI, 0.8), both of which were below the noninferiority margin (2 stools). Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86). Lower doses were also associated with less vomiting beyond 30 minutes after administration.
CONCLUSIONS


Lower doses of zinc had noninferior efficacy for the treatment of diarrhea in children and were associated with less vomiting than the standard 20-mg dose. (Funded by the Bill and Melinda Gates Foundation; ZTDT ClinicalTrials.gov number, NCT03078842.).",2020,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","['children with acute diarrhea', '4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea', 'Childhood Diarrhea ']",['zinc sulfate'],"['percentage of children with diarrhea', 'Vomiting', 'occurrence of vomiting', 'diarrhea duration of more than 5 days and the number of stools', 'mean number of diarrheal stools', 'vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C4517780', 'cui_str': '4500'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4500.0,0.0686028,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Somji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Prabhabati', 'Initials': 'P', 'LastName': 'Devi', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Om P', 'Initials': 'OP', 'LastName': 'Semwal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1915905']
2093,32967404,Intradiscal Pulsed Radiofrequency Application Duration Effect on Lumbar Discogenic Low Back Pain.,"BACKGROUND


Discogenic pain is recognized as the most important and most common cause of low back pain (LBP). Intradiscal pulsed radiofrequency (ID-PRF) is used for the treatment of chronic discogenic pain.
OBJECTIVES


We investigated the effects of the duration of percutaneous monopolar ID-PRF application on chronic discogenic LBP.
STUDY DESIGN


Retrospective study.
SETTING


Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital.
METHODS


Forty-five patients were included in this retrospective study. The patients were assigned into 2 groups according to the duration of the PRF procedure they underwent (7-minute group = 17 patients vs. 15-minute group = 28 patients). The main outcome measures tested were pain score, as determined by the Numeric Rating Scale (NRS-11) and the Oswestry Disability Index (ODI), at baseline, at 2-week, and 6-month follow-up visits. Success was defined as a reduction in NRS-11 of 50% or more or an ODI reduction of 40% or more.
RESULTS


The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant. ODI scores were also significantly lower compared with the baseline, but the differences between the groups were not significant. At the 6-month follow-up, 12 patients (70.6%) in the 7-minute group and 20 patients (71.4%) in the 15-minute group reported more than 50% reduction in the pain score (P = 0.16), and there was no significant difference between the 2 groups in the number of patients with more than 40% reduction in ODI score (P = 0.23).
LIMITATIONS


This study was performed with a small sample size and there was no control group. Additional well-designed and well-controlled studies that include parameters such as the stimulation duration, mode, and intensity of PRF are needed to fully assess the efficiency of ID-PRF.
CONCLUSIONS


ID-PRF was shown to be effective for the treatment of discogenic LBP regardless of duration of ID-PRF application (7 vs. 15 minutes).",2020,"The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant.","['Forty-five patients', 'Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital', 'chronic discogenic pain']","['Intradiscal pulsed radiofrequency (ID-PRF', 'Intradiscal Pulsed Radiofrequency Application Duration Effect', 'percutaneous monopolar ID-PRF application']","['mean posttreatment pain scores', 'Lumbar Discogenic Low Back Pain', 'ODI scores', 'ODI reduction', 'pain score, as determined by the Numeric Rating Scale (NRS-11) and the Oswestry Disability Index (ODI', 'ODI score', 'pain score']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3662528', 'cui_str': 'Discogenic pain'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0303313,"The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant.","[{'ForeName': 'Chan Hong', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Daegu Wooridul Spine Hospital, Jung-Gu, Daegu, Republic of Korea.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Wooridul Spine Hospital, Korea.'}, {'ForeName': 'Pyng Bok', 'Initials': 'PB', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Korea.'}]",Pain physician,[]
2094,32967406,High-Voltage Intraarticular Pulsed Radiofrequency for Chronic Knee Pain Treatment: A Single-Center Retrospective Study.,"BACKGROUND


Intraarticular pulsed radiofrequency (IAPRF) for the treatment of painful knee osteoarthritis (KOA) is a less invasive treatment method. It has fewer adverse effects and can quickly reduce KOA-related pain and improve knee joint dysfunction.
OBJECTIVES


We compared the effectiveness of high- and low-voltage IAPRF for the treatment of chronic knee pain.
STUDY DESIGN


Retrospective comparative study design.
SETTING


This study took place at Shengjing Hospital of China Medical University.
METHODS


A total of 57 patients with KOA who were hospitalized between July 2018 and July 2019 were randomly allocated into the high-voltage (n = 29) and low-voltage (n = 28) IAPRF groups. IAPRF was performed under the guidance of computed tomography (CT). Numeric Rating Scale (NRS-11), Oxford Knee Score (OKS), degree of pain relief, global perceived effect, and side effects at baseline and 1 week, 2 weeks, 1 month, 3 months, and 6 months after the procedure were recorded and analyzed.
RESULTS


NRS-11 scores decreased significantly in both groups after the procedure, but gradually increased after the 6-month follow-up period. There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure. OKS were similar between the 2 groups. Patients with pain relief rate 50% or greater at 1, 3, and 6 months after the procedure accounted for 72.41%, 72.41%, and 55.17% in the high-voltage group, and 46.43%, 46.43%, and 28.57% in the low-voltage group, respectively. The difference between the 2 groups was statistically significant. No significant adverse reactions were observed in the 2 groups, however, patient satisfaction in the high-voltage group was significantly higher compared with patients in the low-voltage group.
LIMITATIONS


This study was a single-center retrospective study with a relatively small sample cohort and short follow-up period.
CONCLUSIONS


CT-guided high-voltage IAPRF is more beneficial in reducing knee pain and improving knee function compared with low-voltage IAPRF. In addition, patients who received high-voltage IAPRF were more satisfied with their treatment.",2020,There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure.,"['Chronic Knee Pain Treatment', '57 patients with KOA who were hospitalized between July 2018 and July 2019', 'chronic knee pain', 'place at Shengjing Hospital of China Medical University', 'painful knee osteoarthritis (KOA']","['Intraarticular pulsed radiofrequency (IAPRF', 'CT-guided high-voltage IAPRF', 'high- and low-voltage IAPRF', 'High-Voltage Intraarticular Pulsed Radiofrequency', 'IAPRF']","['NRS-11 scores', 'Numeric Rating Scale (NRS-11), Oxford Knee Score (OKS), degree of pain relief, global perceived effect, and side effects', 'patient satisfaction', 'adverse reactions', 'knee pain and improving knee function', 'OKS', 'pain relief rate']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",57.0,0.033429,There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Guangxiao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Pain physician,[]
2095,32967646,Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV.,"BACKGROUND


Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries' bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress.
METHODS


PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized (""choice"") study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators.
DISCUSSION


The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103) .",2020,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","['Fifty additional participants', 'PLWH (n\u2009', 'marginalized people living with HIV (PLWH', '160) receiving services at community-based organizations', 'marginalized people living with HIV']","['CCRP intervention or control', 'Client-Centered Representative Payee (CCRP', 'CCRP', 'client-centered Representative Payee Services', 'CCRP intervention']","['antiretroviral therapy adherence', 'HIV health disparities', 'ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care', 'Viral load, CD4, and appointment adherence data', 'HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",,0.254784,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","[{'ForeName': 'Abisola', 'Initials': 'A', 'LastName': 'Olaniyan', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Creasy', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'Department of Social Work, College of Arts and Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria Mori', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maulsby', 'Affiliation': 'Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Musgrove', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hagan', 'Affiliation': 'Action Wellness, Philadelphia, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Sashin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Farmartino', 'Affiliation': 'The Open Door, Inc., Pittsburgh, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hawk', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA. meh96@pitt.edu.'}]",BMC public health,['10.1186/s12889-020-09500-z']
2096,32968274,Local exposure to inequality raises support of people of low wealth for taxing the wealthy.,"Psychological research shows that social comparison of individuals with peers or others shapes attitude formation 1,2 . Opportunities for such comparisons have increased with global inequality 3,4 ; everyday experiences can make economic disparities more salient through signals of social class 5,6 . Here we show that, among individuals with a lower socioeconomic status, such local exposure to inequality drives support for the redistribution of wealth. We designed a placebo-controlled field experiment conducted in South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car. Pedestrians were asked to sign a petition to increase taxes on wealthy individuals to help with the redistribution of wealth. We found an increase of eleven percentage points in the probability of signing the petition in the presence of inequality, when taking into account the experimental placebo effect. The placebo effect suppresses the probability that an individual signs the petition in general, which is consistent with evidence that upward social comparison reduces political efficacy 4 . Measures of economic inequality were constructed at the neighbourhood level and connected to a survey of individuals with a low socioeconomic status. We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities. Inequality seems to affect preferences for the redistribution of wealth through local exposure. However, our results indicate that inequality may also suppress participation; the political implications of our findings at regional or country-wide scales therefore remain uncertain.",2020,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"['South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car', 'individuals with peers or others shapes attitude formation 1,2 ']",['placebo'],[],"[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0306861,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Sands', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. msands2@ucmerced.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Kadt', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. ddekadt@ucmerced.edu.'}]",Nature,['10.1038/s41586-020-2763-1']
2097,32975441,"EEG biomarkers acquired during a short, straight-line simulated drive to predict impairment from cannabis intoxication.","OBJECTIVE


As cannabis use becomes more widely accepted, there is growing interest in its effects on brain function, specifically how it may impact daily functional activities such as driving, operating machinery, and other safety-related tasks. There are currently no validated methods for quantifying impairment from acute cannabis intoxication. The objective of this study was to identify neurophysiological correlates associated with driving simulator performance in subjects who were acutely intoxicated with cannabis. These signatures could help create an EEG-based profile of impairment due to acute cannabis intoxication.
METHODS


Each subject completed a three-visit study protocol. Subjects were consented and screened on the first visit. On the second and third visits, subjects were administered either 500 mg of cannabis with 6.7% delta-9-tetrahydrocannabinol (THC) or placebo using a Volcano© Digit Vaporizer in a counterbalanced fashion. EEG was acquired from subjects as they performed a series of neurocognitive tasks and an approximately 45-minute simulated drive that included a rural straight-away absent of any other cars or obstacles during the final 10 minutes. EEG data was acquired using a STAT X24 wireless sensor headset during a simulated driving scenario from 10 subjects during the THC and placebo visits. Metrics of driving performance were extracted from the driving simulator and synchronized with EEG data using a common clock.
RESULTS


A within-subjects analysis showed that the standard deviation of lane position (SDLP) was significantly worse and heart rate was elevated during the dosed visit compared to the placebo visit. Consistent with our prior findings, EEG power in the Theta frequency band (4-7 Hz) in the dosed condition was significantly decreased from the placebo condition. Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
CONCLUSIONS


These results, in combination with prior work on the effect of cannabis intoxication during neurocognitive tasks, suggest that neurophysiological signatures associated with acute cannabis intoxication are robust and consistent across tasks, and that these signatures are significantly correlated with impaired performance in a driving simulator. Taken together, EEG data acquired during a short neurocognitive testbed and during a simulated drive may provide specific profiles of impairment associated with acute cannabis intoxication. Further research is needed to establish the impaired cognitive processes associated with these EEG biomarkers.",2020,"Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
",['subjects who were acutely intoxicated with cannabis'],"['placebo', '500\u2009mg of cannabis with 6.7% delta-9-tetrahydrocannabinol']","['standard deviation of lane position (SDLP', 'EEG measure and SDLP', 'heart rate', 'SDLP driving performance metric']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",,0.120117,"Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
","[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Brown', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Richard', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Meghdadi', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Stevanović Karić', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rupp', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Schmitt', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Gaffney', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Milavetz', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Berka', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}]",Traffic injury prevention,['10.1080/15389588.2020.1814957']
2098,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE


Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS


In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS


Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION


In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
2099,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2100,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2101,32971593,Blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: A pilot study.,"BACKGROUND


This study evaluated the Blossom system, an innovative self-filling, rate-controlled, pressure-responsive saline tissue expander (TE) system. We investigated the feasibility of utilizing this technology to facilitate implant-based and combined flap with implant-based breast reconstruction in comparison to conventional tissue expansion.
METHODS


In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction. Outcome measures included time to full expansion, complications, total expansion volume, and pain scores.
RESULTS


Fourteen patients (TEs; n=22), were included in this study. The mean time to full expansion was 13.4 days (standard error of the mean [SEM], 1.3 days) in the combination group and 11.7 days (SEM, 1.4 days) in the implant group (P=0.78). The overall major complication rate was 4.5% (n=1). No statistically significant differences were found in the complication rate between the combination group and the implant group. The maximum patient-reported pain scores during the expansion process were low, but were significantly higher in the combination group (mean, 2.00±0.09) than in the implant group (mean, 0.29±0.25; P=0.005).
CONCLUSIONS


The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%).",2020,No statistically significant differences were found in the complication rate between the combination group and the implant group.,['Fourteen patients (TEs; n=22'],"['combined flap with implant-based breast reconstruction', 'implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction']","['mean time to full expansion', 'overall complication rate', 'complication rate', 'time to full expansion, complications, total expansion volume, and pain scores', 'complication rates', 'overall major complication rate', 'pain scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0401048,No statistically significant differences were found in the complication rate between the combination group and the implant group.,"[{'ForeName': 'Youna K', 'Initials': 'YK', 'LastName': 'Choi', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Rochlin', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Dung H', 'Initials': 'DH', 'LastName': 'Nguyen', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}]",Archives of plastic surgery,['10.5999/aps.2020.00535']
2102,32976633,A randomized trial of permanent supportive housing for chronically homeless persons with high use of publicly funded services.,"OBJECTIVE


To examine whether randomization to permanent supportive housing (PSH) versus usual care reduces the use of acute health care and other services among chronically homeless high users of county-funded services.
DATA SOURCES


Between 2015 and 2019, we assessed service use from Santa Clara County, CA, administrative claims data for all county-funded health care, jail and shelter, and mortality.
STUDY DESIGN


We conducted a randomized controlled trial among chronically homeless high users of multiple systems. We compared postrandomization outcomes from county-funded systems using multivariate regression analysis.
DATA COLLECTION


We extracted encounter data from an integrated database capturing health care at county-funded facilities, shelter and jails, county housing placement, and death certificates.
PRINCIPAL FINDINGS


We enrolled 423 participants (199 intervention; 224 control). Eighty-six percent of those randomized to PSH received housing compared with 36 percent in usual care. On average, the 169 individuals housed by the PSH intervention have remained housed for 28.8 months (92.9 percent of the study follow-up period). Intervention group members had lower rates of psychiatric ED visits IRR 0.62; 95% CI [0.43, 0.91] and shelter days IRR 0.30; 95% CI [0.17, 0.53], and higher rates of ambulatory mental health services use IRR 1.84; 95% CI [1.43, 2.37] compared to controls. We found no differences in total ED or inpatient use, or jail. Seventy (37 treatment; 33 control) participants died.
CONCLUSIONS


The intervention placed and retained frequent user, chronically homeless individuals in housing. It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations. Limitations included more than one-third of usual care participants received another form of subsidized housing, potentially biasing results to the null, and loss of power due to high death rates. PSH can house high-risk individuals and reduce emergent psychiatric services and shelter use. Reductions in hospitalizations may be more difficult to realize.",2020,"It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations.","['chronically homeless high users of multiple systems', 'chronically homeless persons with high use of publicly funded services', '169 individuals housed by the', 'Seventy (37 treatment; 33 control) participants died', 'chronically homeless high users of county-funded services', 'chronically homeless individuals in housing', 'We enrolled 423 participants (199 intervention; 224 control']","['PSH intervention', 'PSH', 'permanent supportive housing (PSH) versus usual care', 'permanent supportive housing']","['total ED or inpatient use, or jail', 'rates of ambulatory mental health services', 'psychiatric ED visits and shelter use, and increased outpatient mental health care', 'rates of psychiatric ED visits IRR', 'service use from Santa Clara County, CA, administrative claims data for all county-funded health care, jail and shelter, and mortality']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",423.0,0.115193,"It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations.","[{'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Raven', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Kushel', 'Affiliation': 'Mathematica Policy Research, Oakland, CA, USA.'}]",Health services research,['10.1111/1475-6773.13553']
2103,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS


In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS


Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION


Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION


REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
2104,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
2105,32977212,Behavioral and electrophysiological effects of network-based frontoparietal tDCS in patients with severe brain injury: A randomized controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) may promote the recovery of severely brain-injured patients with disorders of consciousness (DOC). Prior tDCS studies targeted single brain regions rather than brain networks critical for consciousness recovery.
OBJECTIVE


Investigate the behavioral and electrophysiological effects of multifocal tDCS applied over the frontoparietal external awareness network in patients with chronic acquired DOC.
METHODS


Forty-six patients were included in this randomized double-blind sham-controlled crossover trial (median [interquartile range]: 46 [35 - 59] years old; 12 [5 - 47] months post injury; 17 unresponsive wakefulness syndrome, 23 minimally conscious state (MCS) and 6 emerged from the MCS). Multifocal tDCS was applied for 20 min using 4 anodes and 4 cathodes with 1 mA per electrode. Coma Recovery Scale-Revised (CRS-R) assessment and 10 min of resting state electroencephalogram (EEG) recordings were acquired before and after the active and sham sessions.
RESULTS


At the group level, there was no tDCS behavioral treatment effect. However, following active tDCS, the EEG complexity significantly increased in low frequency bands (1-8 Hz). CRS-R total score improvement was associated with decreased baseline complexity in those bands. At the individual level, after active tDCS, new behaviors consistent with conscious awareness emerged in 5 patients. Conversely, 3 patients lost behaviors consistent with conscious awareness.
CONCLUSION


The behavioral effect of multifocal frontoparietal tDCS varies across patients with DOC. Electrophysiological changes were observed in low frequency bands but not translated into behavioral changes at the group level.",2020,"At the group level, there was no tDCS behavioral treatment effect.","['severely brain-injured patients with disorders of consciousness (DOC', 'patients with severe brain injury', 'Forty-six patients', 'patients with chronic acquired DOC', 'patients with DOC']","['multifocal tDCS', 'network-based frontoparietal tDCS', 'Transcranial direct current stimulation (tDCS', 'minimally conscious state (MCS) and 6 emerged from the MCS']","['EEG complexity', 'CRS-R total score improvement', 'Electrophysiological changes', 'Coma Recovery Scale-Revised (CRS-R) assessment and 10\xa0min of resting state electroencephalogram (EEG) recordings']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0751699', 'cui_str': 'Minimally conscious state'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",46.0,0.240193,"At the group level, there was no tDCS behavioral treatment effect.","[{'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium. Electronic address: geraldine.martens@uliege.be.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kroupi', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Bodien', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Laboratory for Neuroimaging in Coma and Consciousness, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Frasso', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Annen', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Cassol', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barra', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Martial', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Gosseries', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lejeune', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre Hospitalier Neurologique William Lennox, Saint-Luc University Clinics, Université Catholique de Louvain, Belgium.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium; Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102426']
2106,32977220,Phase I/II trial of sequential treatment of nab-paclitaxel in combination with gemcitabine followed by modified FOLFOX chemotherapy in patients with untreated metastatic exocrine pancreatic cancer: Phase I results.,"BACKGROUND


Although occasioned through different mechanisms, the potential neurotoxicity and also haematological toxicity of nab-paclitaxel and oxaliplatin-based chemotherapy regimen were studied in this trial, which aimed to determine the maximum-tolerated dose (MTD) and to evaluate safety and efficacy of the combination in a sequential regimen of nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX) in untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
MATERIALS AND METHODS


Treatment consisted of nab-paclitaxel (125/100 mg/m 2 ) plus GEM (1000/800 mg/m 2 ) on days 1, 8 and 15, followed by mFOLFOX (oxaliplatin [85/75/65 mg/m 2 ], 5-FU bolus [400/300/200 mg/m 2 ], 5-FU infusion [2400/2000/1600 mg/m 2 ]) on day 28, of a 42-day cycle. Patients were enrolled at the highest dose level with a subsequent 3 + 3 dose de-escalation plan.
RESULTS


Eleven patients (median age = 61, 64% with performance status [PS] = 1) were eligible. All patients received the highest dose level. No de-escalation was needed. A dose-limiting toxicity was reported, an upper gastrointestinal haemorrhage. The MTD was nab-paclitaxel 125 mg/m 2 , GEM 1000 mg/m 2 , oxaliplatin 85 mg/m 2 , 5-FU bolus 400 mg/m 2  and 5-FU infusion 2400 mg/m 2 . Common all-grade toxicities were neutropenia (73%), anaemia (55%), thrombocytopenia (55%) and asthenia (55%). Other relevant toxicities were paraesthesia (46%), nausea (36%), dysesthesia (27%) and pyrexia (27%). Objective response rate was 50% and disease control rate was 80%.
CONCLUSIONS


The regimen of nab-paclitaxel plus GEM followed by mFOLFOX showed favourable safety and tolerability profiles with significant anti-tumor activity. More data are being achieved in a randomised phase II trial, to confirm efficacy rates and dismiss long-term neurotoxicity concerns regarding the sequencing of nab-paclitaxel and oxaliplatin.",2020,No de-escalation was needed.,"['untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC', 'patients with untreated metastatic exocrine pancreatic cancer', 'Eleven patients (median age\xa0=\xa061, 64% with performance status [PS]\xa0=\xa01) were eligible']","['gemcitabine followed by modified FOLFOX chemotherapy', '5-FU infusion 2400', 'nab-paclitaxel', 'paclitaxel', 'paclitaxel and oxaliplatin-based chemotherapy', 'oxaliplatin', 'oxaliplatin 85\xa0mg/m 2 , 5-FU bolus 400', 'nab-paclitaxel plus GEM', 'mFOLFOX (oxaliplatin [85/75/65\xa0mg/m 2 ], 5-FU bolus [400/300/200\xa0mg/m 2 ], 5-FU infusion', 'nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX', 'nab-paclitaxel (125/100\xa0mg/m 2 ) plus GEM']","['disease control rate', 'favourable safety and tolerability profiles', 'thrombocytopenia', 'asthenia', 'nausea', 'Objective response rate', 'neutropenia', 'anaemia', 'pyrexia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0346648', 'cui_str': 'Malignant tumor of exocrine pancreas'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",1.0,0.0271254,No de-escalation was needed.,"[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain. Electronic address: acarrato@telefonica.net.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Vieitez', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodriguez-Garrote', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Castillo', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Gema Durán', 'Initials': 'GD', 'LastName': 'Ogalla', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Laura García', 'Initials': 'LG', 'LastName': 'Bermejo', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Ruiz de Mena', 'Affiliation': 'Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'CIBERONC, Madrid. Spain; IMIBIC, Córdoba. Spain; Reina Sofia University Hospital, Córdoba. Spain; University of Córdoba, Córdoba. Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.035']
2107,32970104,Efficacy of Plinabulin vs Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial.,"Importance


Plinabulin is a novel, non-granulocyte colony-stimulating factor (GCSF) small molecule with both anticancer and neutropenia-prevention effects.
Objective


To assess the efficacy and safety of plinabulin compared with pegfilgrastim for the prevention of chemotherapy-induced neutropenia following docetaxel chemotherapy in patients with non-small lung cancer.
Design, Setting, and Participants


This was a randomized, open-label, phase 2 clinical trial of 4 treatment arms that was conducted in 19 cancer treatment centers in the United States, China, Russia, and Ukraine. Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy. Data were collected from April 2017 through March 2018 and analyzed from August 2019 through February 2020.
Interventions


All patients received docetaxel 75 mg/m2 on day 1 and were randomly assigned to 1 of 3 doses of plinabulin (5, 10, or 20 mg/m2) on day 1 or to pegfilgrastim 6 mg on day 2. Patients were treated every 21 days for 4 chemotherapy cycles.
Main Outcomes and Measures


The primary end point was the determination of the recommended phase 3 dose of plinabulin based on the days of severe neutropenia during chemotherapy cycle 1. Daily complete blood cell counts and absolute neutrophil counts were drawn during times of anticipated neutropenia during cycle 1.
Results


Of the 55 patients randomized and evaluated, the mean (SD) age was 61.3 (10.2) years, and 38 (69.1%) were men. With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased. There were no significant differences in mean (SD) days of severe neutropenia among those treated with pegfilgrastim (0.15 [0.38] days) when dosed at day 2 vs plinabulin 20 mg/m2 (0.36 [0.93] days; P = .76) when dosed at day 1, and no safety signals were detected.
Conclusions and Relevance


Single dose-per-cycle plinabulin has a similar neutropenia protection benefit as pegfilgrastim. Plinabulin 40 mg fixed dose, which is pharmacologically equivalent to 20 mg/m2, will be compared with pegfilgrastim 6 mg in the phase 3 portion of this trial. Noninferior days of severe neutropenia will be the primary end point, and bone pain reduction, thrombocytopenia reduction, and quality of life maintenance will be secondary end points.
Trial Registration


ClinicalTrials.gov Identifier: NCT03102606.",2020,"With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased.","['19 cancer treatment centers in the United States, China, Russia, and Ukraine', 'the mean (SD) age was 61.3 (10.2) years, and 38 (69.1%) were men', 'Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy', 'Adults With Non-Small Cell Lung Cancer', 'Data were collected from April 2017 through March 2018 and analyzed from August 2019 through February 2020', 'patients with non-small lung cancer']","['docetaxel chemotherapy', 'pegfilgrastim', 'plinabulin', 'docetaxel', 'Plinabulin vs Pegfilgrastim']","['severe neutropenia', 'efficacy and safety', 'mean (SD) days of severe neutropenia', 'bone pain reduction, thrombocytopenia reduction, and quality of life maintenance', 'Daily complete blood cell counts and absolute neutrophil counts']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0265783', 'cui_str': 'Congenital hypoplasia of lung'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",55.0,0.0885841,"With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased.","[{'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Blayney', 'Affiliation': 'Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research, Nanjing, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, Ukraine. Dnepropetrovsk, Ukraine.'}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Sumy Regional Clinical Oncology Dispensary, Sumy State University, Sumy, Ukraine.'}, {'ForeName': 'Nadezhda', 'Initials': 'N', 'LastName': 'Kovalenko', 'Affiliation': 'Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russia.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Mid Florida Hematology and Oncology Center, Orange City.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Ibrahim', 'Affiliation': 'Redlands Community Hospital, Redlands, California.'}, {'ForeName': 'Dmitriy Petrovich', 'Initials': 'DP', 'LastName': 'Udovista', 'Affiliation': 'SBI of Healthcare Oncology Dispensary No. 2, Ministry of Health of Krasnodar Region, Sochi, Russia.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Mohanlal', 'Affiliation': 'BeyondSpring Pharmaceuticals, New York, New York.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ogenstad', 'Affiliation': 'Statogen Consulting, Wake Forest, North Carolina.'}, {'ForeName': 'Ene', 'Initials': 'E', 'LastName': 'Ette', 'Affiliation': 'Anoixis Corporation, Natick, Massachusetts.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Wanchun Bulin Pharmaceuticals Limited, Dalian, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'BeyondSpring Pharmaceuticals, New York, New York.'}, {'ForeName': 'Yuan-Kai', 'Initials': 'YK', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4429']
2108,32966703,"Food Structure Modulates the Bioavailability of Triglycerides and Vitamin D, and Partly That of Lutein: A Randomized Trial with a Crossover Design in Adults.","SCOPE


The specific effect of the food matrix structure on fat-soluble micronutrient bioavailability is only partly understood. Evaluating fat-soluble micronutrient bioavailability after consumption of foods displaying similar composition but different structure is aimed at.
METHODS AND RESULTS


Twelve healthy subjects are enrolled in a randomized, open label, crossover postprandial trial. Four different model foods are tested: custard, pudding, sponge cake, and biscuit. Vitamin D 3  , lutein, and triglyceride chylomicron responses, evaluated as postprandial areas under the curve, are then assayed. Custard triglyceride response is higher than pudding and biscuit responses (up to +122.7%, p < 0.0001). Sponge cake vitamin D 3  response is higher than biscuit response (+26.6%, p = 0.047). No difference between the model foods are observed regarding lutein responses. Triglyceride responses peak at 3 h for all conditions, while vitamin D 3  and lutein peaks are delayed by 1 h with the biscuit matrix compared to other model foods.
CONCLUSION


Food structure can significantly impact on triglyceride and vitamin D 3  bioavailability in terms of absorbed amounts and/or maximum absorption time. The data highlight positive correlations between triglyceride, vitamin D, and lutein nutrient responses. These results are of particular interest to develop functional foods for population subgroups such as the elderly.",2020,"Sponge cake vitamin D 3  response was higher than biscuit response (+26.6%, p = 0.047).","['humans after consumption of foods displaying similar composition but different structure', 'Adults', 'Twelve healthy subjects']","['Sponge cake vitamin D', 'Lutein']","['Custard triglyceride response', 'biscuit response', 'Vitamin D 3  , lutein and triglyceride chylomicron responses', 'triglyceride, vitamin D and lutein responses', 'Bioavailability of Triglycerides and Vitamin D', 'TG responses', 'lutein responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0452620', 'cui_str': 'Sponge cake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",12.0,0.0333842,"Sponge cake vitamin D 3  response was higher than biscuit response (+26.6%, p = 0.047).","[{'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Gleize', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Hiolle', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Meunier', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, 63000, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Savary-Auzeloux', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buffière', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Marie-Agnès', 'Initials': 'MA', 'LastName': 'Peyron', 'Affiliation': 'INRAE, Unité de Nutrition Humaine, UMR1019, University Clermont Auvergne, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Halimi', 'Affiliation': 'Aix-Marseille Université, INRAE, INSERM, C2VN, Marseille, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Caris-Veyrat', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Nau', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Reboul', 'Affiliation': 'Aix-Marseille Université, INRAE, INSERM, C2VN, Marseille, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000228']
2109,32966714,Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes.,"BACKGROUND


The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established.
METHODS


In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.
RESULTS


A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI, 0.75 to 1.03; P = 0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%) who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received the 15-mg dose, as compared with 45 patients (1.6%) who received placebo.
CONCLUSIONS


Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).",2020,The hazard ratio for death from cardiovascular causes was 0.92,"['Type 2 Diabetes', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease to', '8238 patients who received at least one dose of', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease', '8246 patients underwent randomization and were followed for a mean of 3.5 years']","['Ertugliflozin', 'ertugliflozin vs. placebo', 'placebo', 'receive 5 mg or 15 mg of ertugliflozin or placebo', 'ertugliflozin or placebo', 'ertugliflozin']","['hazard ratio for death from cardiovascular causes', 'Cardiovascular Outcomes', 'Amputations', 'adverse cardiovascular event', 'composite of death from cardiovascular causes or hospitalization for heart failure', 'major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke', 'hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level', 'Death from cardiovascular causes or hospitalization for heart failure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",8246.0,0.755502,The hazard ratio for death from cardiovascular causes was 0.92,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Masiukiewicz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Weichung J', 'Initials': 'WJ', 'LastName': 'Shih', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004967']
2110,32967495,Effect of intersphincteric fistula tract ligation versus anal fistulectomy on pain scores and serum levels of vascular endothelial growth factor and interleukin-2 in patients with simple anal fistulas.,"OBJECTIVE


This study was performed to explore the effects of ligation of the intersphincteric fistula tract (LIFT) on pain scores and serum levels of vascular endothelial growth factor (VEGF) and interleukin (IL)-2 in patients with simple anal fistulas.
METHODS


Ninety patients with simple anal fistulas were evenly randomized into a study group (treated with LIFT) and a control group (treated with traditional anal fistulectomy) according to a random number table. The surgical outcomes, basic operation conditions (operation time, hospital stay, and anal continence), and postoperative wound healing rates were compared between the two groups.
RESULTS


The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group. However, the incidence of postoperative complications was not significantly different between the two groups.
CONCLUSIONS


Patients who underwent LIFT had better surgical outcomes, higher wound healing rates, better anal continence, a shorter length of hospital stay, and less severe postoperative pain than those who underwent simple anal fistulectomy. Increased levels of VEGF and IL-2 after surgery may promote wound healing.",2020,"The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group.","['Ninety patients with simple anal fistulas', 'patients with simple anal fistulas']","['intersphincteric fistula tract (LIFT', 'intersphincteric fistula tract ligation versus anal fistulectomy', 'LIFT', 'control group (treated with traditional anal fistulectomy']","['severe postoperative pain', 'pain scores and serum levels of vascular endothelial growth factor and interleukin-2', 'pain scores and serum levels of vascular endothelial growth factor (VEGF) and interleukin (IL)-2', 'incidence of postoperative complications', 'surgical outcomes, basic operation conditions (operation time, hospital stay, and anal continence), and postoperative wound healing rates', 'operation conditions (better anal continence and shorter length of hospital stay', 'surgical outcomes, higher wound healing rates, better anal continence, a shorter length of hospital stay', 'postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}]","[{'cui': 'C0341379', 'cui_str': 'Intersphincteric fistula'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0193125', 'cui_str': 'Anal fistulectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1290944', 'cui_str': 'Anorectal continence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",90.0,0.0391366,"The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Zhanbo', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Bianfang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Fagang', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}]",The Journal of international medical research,['10.1177/0300060520949072']
2111,32967500,GPX3  methylation is associated with hematologic improvement in low-risk myelodysplastic syndrome patients treated with Pai-Neng-Da.,"OBJECTIVE


The aim of this prospective randomized controlled clinical trial was to explore the relationship between  GPX3  methylation and Pai-Neng-Da (PND) in the treatment of patients with low-risk myelodysplastic syndrome (MDS).
METHODS


There were 82 low-risk MDS patients who were randomly divided into the following two groups: androl, thalidomide, and PND capsule (ATP group, n = 41); or androl and thalidomide (AT group, n = 41). Hemoglobin and neutrophil and platelet counts and changes in  GPX3  methylation level were assessed.
RESULTS


The plasma hemoglobin level increased in both groups after treatment. However, the platelet count increased only in the ATP group. Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT. Moreover, male patients had a significantly lower  GPX3  methylation level than female patients, while platelet counts from male patients increased dramatically after the ATP regimens compared with female patients.  GPX3  methylation changes were negatively correlated with platelet changes in ATP group.
CONCLUSION


PND can improve hematological parameters and decrease the  GPX3  methylation level. Decreasing  GPX3  methylation is associated with the hematologic response that includes platelet in  GPX3  methylation. China Clinical Trial Bureau (ChiCTR;  http://www.chictr.org.cn/ ) registration number : ChiCTR-IOR-15006635.",2020,"Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT.","['patients with low-risk myelodysplastic syndrome (MDS', '82 low-risk MDS patients']","['Pai-Neng-Da (PND', 'androl, thalidomide, and PND capsule (ATP group, n\u2009=\u200941); or androl and thalidomide', 'PND']","['platelet counts', 'platelet response', 'GPX3  methylation', 'GPX3  methylation level', 'Hemoglobin and neutrophil and platelet counts and changes in  GPX3  methylation level', 'platelet count', 'hematological parameters', 'Decreasing  GPX3', 'plasma hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]","[{'cui': 'C4310131', 'cui_str': 'pai-neng-da'}, {'cui': 'C1956415', 'cui_str': 'Paroxysmal nocturnal dyspnea'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0474563', 'cui_str': 'Measurement of total hemoglobin concentration in plasma specimen'}]",82.0,0.0423834,"Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT.","[{'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhijuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Jiaping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Ouyang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060520956894']
2112,32967513,Psychological state of patients with sudden deafness and the effect of psychological intervention on recovery.,"OBJECTIVE


To determine the effect of personalized psychological interventions on the recovery of patients with sudden deafness.
METHODS


Participants were 438 patients with sudden deafness who were randomly allocated to observation and control groups. Patients in the control group received routine nursing care and drug treatment. Patients in the observation group received personalized psychological interventions, routine nursing care and drug treatment. The Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS) were used to measure anxiety and depression. The Simple Coping Style Questionnaire (SCSQ) and the Satisfaction With Life Scale (SWLS) were used to evaluate coping styles, attitude toward life and quality of life.
RESULTS


Patients in both groups had similar SAS and SDS scores at the time of admission. After treatment, there was a significant difference in SAS and SDS scores between the observation and control groups, indicating that the observation group had less anxiety and depression. Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
CONCLUSION


Effective psychological interventions may change negative thoughts, increase response rate and improve quality of life.",2020,"Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
","['Participants were 438 patients with sudden deafness who were randomly allocated to observation and control groups', 'patients with sudden deafness']","['personalized psychological interventions, routine nursing care and drug treatment', 'psychological intervention', 'personalized psychological interventions', 'routine nursing care and drug treatment']","['SAS and SDS scores', 'SCSQ and SWLS scores', 'Simple Coping Style Questionnaire (SCSQ) and the Satisfaction With Life Scale (SWLS', 'Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS', 'positive coping and satisfaction with life', 'response rate and improve quality of life', 'coping styles, attitude toward life and quality of life', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",438.0,0.022125,"Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, The School Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Zhenghui', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}]",The Journal of international medical research,['10.1177/0300060520957536']
2113,32969040,"A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants.","AIM


To determine whether closed loop automated oxygen control resulted in a reduction in the duration and severity of desaturation episodes and the number of blood gases and chest radiographs in preterm, ventilated infants.
METHODS


Infants were studied on two consecutive days for 12 hours on each day. They were randomised to receive standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first.
RESULTS


Twenty-four infants with a median gestational age of 25.7 (range 23.1-32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3-34.9) weeks. During the automated oxygen control period, there were fewer desaturations that lasted >30 seconds (P = .032) or >60 seconds (P = .002), infants spent a higher proportion of the time within their target SpO 2  range during the automated oxygen control period (P < .001), and fewer manual adjustments were made to the inspired oxygen concentration (mean 0.58 vs mean 11.29) (P < .001). There were no significant differences in the number of blood gases (P = .872) or chest radiographs (P = .366) between the two periods.
CONCLUSION


Closed loop automated oxygen delivery resulted in fewer prolonged desaturations with more time spent in the targeted oxygen range.",2020,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","['Infants were studied on two consecutive days for 12 hours on each day', 'preterm, ventilated infants', 'Twenty-four infants with a median gestational age of 25.7 (range 23.1 - 32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3 - 34.9) weeks']","['standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first', 'closed loop automated oxygen control']","['inspired oxygen concentration', 'duration and severity of desaturation episodes and the number of blood gases and chest radiographs', 'number of blood gases (p=0.872) or chest radiographs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5192328', 'cui_str': '27.4'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",24.0,0.161216,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sturrock', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Ambulkar', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Williams', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sweeney', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Nadja F', 'Initials': 'NF', 'LastName': 'Bednarczuk', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Dassios', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15585']
2114,32969200,Modulation of gut mucosal microbiota as a mechanism of probiotics-based adjunctive therapy for ulcerative colitis.,"This was a pilot study aiming to evaluate the effects of probiotics as adjunctive treatment for ulcerative colitis (UC). Twenty-five active patients with UC were assigned to the probiotic (n = 12) and placebo (n = 13) groups. The probiotic group received mesalazine (60 mg kg -1   day -1  ) and oral probiotics (containing Lactobacillus casei Zhang, Lactobacillus plantarum P-8 and Bifidobacterium animalis subsp. lactis V9) twice daily for 12 weeks, while the placebo group received the same amounts of mesalazine and placebo. The clinical outcomes were assessed. The gut mucosal microbiota was profiled by PacBio single-molecule, real-time (SMRT) sequencing of the full-length 16S rRNA of biopsy samples obtained by colonoscopy. A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034). The probiotics could protect from diminishing of the microbiota diversity and richness. Moreover, the gut mucosal microbiota of the probiotic-receivers had significantly more beneficial bacteria like Eubacterium ramulus (P < 0.05), Pediococcus pentosaceus (P < 0.05), Bacteroides fragilis (P = 0.02) and Weissella cibaria (P = 0.04). Additionally, the relative abundances of the beneficial bacteria correlated significantly but negatively with the UCDAI score, suggesting that the probiotics might alleviate UC symptoms by modulating the gut mucosal microbiota. Our research has provided new insights into the mechanism of symptom alleviation in UC by applying probiotic-based adjunctive treatment.",2020,"A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034).","['Twenty-five active patients with UC', 'ulcerative colitis (UC', 'ulcerative colitis']","['mesalazine and placebo', 'probiotics', 'oral probiotics (containing Lactobacillus casei Zhang, Lactobacillus plantarum P-8 and Bifidobacterium animalis subsp', 'placebo', 'probiotics-based adjunctive therapy', 'mesalazine']","['Pediococcus pentosaceus', 'Bacteroides fragilis', 'Weissella cibaria', 'gut mucosal microbiota', 'UC disease activity index (UCDAI', 'remission rate', 'beneficial bacteria like Eubacterium ramulus']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0445656', 'cui_str': 'Pediococcus pentosaceus'}, {'cui': 'C1066567', 'cui_str': 'Weissella cibaria'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0317500', 'cui_str': 'Eubacterium ramulus'}]",25.0,0.0533351,"A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Chengcong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Lai-Yu', 'Initials': 'LY', 'LastName': 'Kwok', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Cong', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'YanFang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Wenyi', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'XiaoFeng', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, 100029, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}]",Microbial biotechnology,['10.1111/1751-7915.13661']
2115,32974894,Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.,"OBJECTIVES


To determine whether in pre-stented patients undergoing ureteroscopic stone removal (ureteroscopy retrograde surgery) a tubeless procedure provides a better outcome compared with short-term (6 h) ureteral stenting using an external ureteral catheter.
METHODS


In this single academic center study (Fast Track Stent study 2), carried out between May 2016 and April 2018, 121 patients with renal or ureteral calculi were initially treated with double-J insertion. Before secondary ureteroscopy retrograde surgery, patients were prospectively randomized into two groups: tubeless versus ureteral catheter insertion for 6 h after ureteroscopy retrograde surgery. Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25 mm. Study end-points were stent-related symptoms assessed by a validated questionnaire (ureteral stent symptom questionnaire), administered both before and 4 weeks after surgery. Numerical ureteral stent symptom questionnaire scores were compared using the Mann-Whitney-U-test. The level of significance was defined as P < 0.05.
RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37). Patient groups did not differ significantly in their ureteral stent symptom questionnaire scores (urinary index P = 0.24; pain index P = 0.35). Patients showed a significant preference for tubeless procedure over ureteral catheter reinsertion (Question GQ P < 0.0001). The reintervention rate was 13.3% for the tubeless procedure (n = 8) and 1.6% for the ureteral catheter group (n = 1), respectively (P = 0.034).
CONCLUSIONS


Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction in pre-stented patients result in comparable quality of life. However, the reintervention rate is higher for tubeless procedures.",2020,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","['121 patients with renal or ureteral calculi were initially treated with double-J insertion', 'Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25\xa0mm']","['Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction', 'tubeless versus ureteral catheter insertion for 6\xa0h after ureteroscopy retrograde surgery', 'ureteroscopy retrograde surgery', 'short-term (6\xa0h) ureteral stenting using an external ureteral catheter', 'ureteroscopic stone removal (ureteroscopy retrograde surgery', 'Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction']","['mean operation time', 'Numerical ureteral stent symptom questionnaire scores', 'reintervention rate', 'stone removal', 'quality of life', 'tubeless procedure over ureteral catheter reinsertion', 'ureteral stent symptom questionnaire scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242147', 'cui_str': 'Acute urinary tract infection'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",121.0,0.0665746,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Reicherz', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Maas', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dahlkamp', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Palisaar', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Bodman', 'Affiliation': 'Uroviva Klinik AG, Bülach, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Noldus', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14291']
2116,32975922,Subclinical hypothyroidism in pregnancy: controversies on diagnosis and treatment.,"The negative impact of even subtle maternal thyroid hormone deficiency on pregnancy outcome and intellectual development of progeny has been known for many years but unfortunately the diagnosis and treatment of subclinical hypothyroidism in pregnant women still evokes controversies. Due to physiological changes in thyroid function and thyroid hormones metabolism occuring during pregnancy the trimester-specific reference ranges for thyroid-stimulating hormone (TSH) and free thyroid hormones should be established, but because of inter-assay differences and other confounders including ethnicity and iodine intake such norms are reliable only for local populations and unique laboratory method. In turn, the fixed reference ranges suggested by endocrine societies may carry a risk of misclassification some healthy pregnant women to be hypothyroid. The value of levothyroxine treatment on pregnancy and children cognitive outcomes is not clear. Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l. The possible harmful effect of treatment includes preterm delivery, gestational diabetes, hypertension and pre-eclampsia. The only three prospective, randomized, placebo controlled trials evaluating efficacy of levothyroxine therapy on children intelligence quotient were started in the second trimester, may be too late to demonstrate differences between treatment and placebo groups. Awaiting for the results of future trials clinician should be aware that low-dose levothyroxine 25-50 µg daily is probably not harmful and may be beneficial but mechanistic implementation of therapy in each pregnant women with TSH >2.5mU/l seems too simplistic.",2020,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","['Subclinical hypothyroidism in pregnancy', 'pregnant women with TSH >2.5mU', 'healthy pregnant women']","['levothyroxine', 'levothyroxine therapy', 'placebo']","['preterm delivery, gestational diabetes, hypertension and pre-eclampsia', 'children intelligence quotient', 'miscarriage and preterm delivery rates']","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.104699,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Gietka-Czernel', 'Affiliation': 'Department of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Glinicki', 'Affiliation': 'Department of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland. piotr.glinicki@bielanski.med.pl'}]",Polish archives of internal medicine,['10.20452/pamw.15626']
2117,32970554,Development and Usability Testing of a Web-based COVID-19 Self-triage Platform.,"INTRODUCTION


The development and deployment of a web-based, self-triage tool for severe respiratory syndrome coronavirus 2 (COVID-19 disease) aimed at preventing surges in healthcare utilization could provide easily understandable health guidance with the goal of mitigating unnecessary emergency department (ED) and healthcare visits. We describe the iterative development and usability testing of such a tool. We hypothesized that adult users could understand and recall the recommendations provided by a COVID-19 web-based, self-triage tool.
METHODS


We convened a multidisciplinary panel of medical experts at two academic medical schools in an iterative redesign process of a previously validated web-based, epidemic screening tool for the current COVID-19 pandemic. We then conducted a cross-sectional usability study over a 24-hour period among faculty, staff, and students at the two participating universities. Participants were randomly assigned a pre-written health script to enter into the self-triage website for testing. The primary outcome was immediate recall of website recommendations. Secondary outcomes included usability measures. We stratified outcomes by demographic characteristics.
RESULTS


A final sample of 877 participants (mean age, 32 years [range, 19-84 years]; 65.3% female) was used in the analysis. We found that 79.4% of the participants accurately recalled the recommendations provided by the website. Almost all participants (96.9%) found the website easy to use and navigate.
CONCLUSION


Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly. This website appears to be a feasible way to provide evidence-based health guidance to adult patients during a pandemic. Website guidance could be used to reduce unnecessary ED and healthcare visits.",2020,"Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly.","['877 participants (mean age, 32 years [range, 19-84 years]; 65.3% female', 'faculty, staff, and students at the two participating universities', 'Adult users of a COVID-19 self-triage website, recruited from an academic setting']",['pre-written health script to enter into the self-triage website for testing'],"['website easy to use and navigate', 'usability measures', 'immediate recall of website recommendations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}]",877.0,0.0903413,"Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly.","[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Schrager', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Keke', 'Initials': 'K', 'LastName': 'Schuler', 'Affiliation': 'National Center for Disaster Medicine and Public Health, Department, Bethesda, Maryland.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Isakov', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Anna Q', 'Initials': 'AQ', 'LastName': 'Yaffee', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Jacobson', 'Affiliation': 'Rollins School of Public Health, Department of Health Policy and Management, Atlanta, Georgia.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Parker', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': 'Uniformed Services University of the Health Sciences, Department of Military and Emergency Medicine, Bethesda, Maryland.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.7.48217']
2118,32970558,Barrier Enclosure for Endotracheal Intubation in a Simulated COVID-19 Scenario: A Crossover Study.,"INTRODUCTION


Barrier enclosures have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation, but little is known about their impact on procedure performance. We sought to determine whether a barrier enclosure delays time to successful intubation by experienced airway operators.
METHODS


We conducted a crossover simulation study at a tertiary academic hospital. Participants watched a four-minute video, practiced one simulated intubation with a barrier enclosure, and then completed one intubation with and one without the barrier enclosure (randomized to determine order). The primary outcome measure was time from placement of the video laryngoscope at the lips to first delivered ventilation. Secondary outcomes were periprocedural complications and participant responses to a post-study survey.
RESULTS


Proceduralists (n = 50) from emergency medicine and anesthesiology had median intubation times of 23.6 seconds with practice barrier enclosure, 20.5 seconds with barrier enclosure, and 16.7 seconds with no barrier. Intubation with barrier enclosure averaged 4.5 seconds longer (95% confidence interval, 2.7-6.4, p < .001) than without, but was less than the predetermined clinical significance threshold of 10 seconds. Three complications occurred, all during the practice intubation. Barrier enclosure made intubation more challenging according to 48%, but 90% indicated they would consider using it in clinical practice.
CONCLUSION


Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model. Given potential to reduce droplet spread, use of a barrier enclosure may be an acceptable adjunct to endotracheal intubation for those familiar with its use.",2020,Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model.,[],"['minute video, practiced one simulated intubation with a barrier enclosure, and then completed one intubation with and one without the barrier enclosure']","['time from placement of the video laryngoscope at the lips to first delivered ventilation', 'periprocedural complications and participant responses to a post-study survey', 'median intubation times']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.297641,Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model.,"[{'ForeName': 'Torrey A', 'Initials': 'TA', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pollok', 'Affiliation': 'Mayo Clinic, Mayo Clinic Multidisciplinary Simulation Center, Rochester, Minnesota.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Sandefur', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Aidan F', 'Initials': 'AF', 'LastName': 'Mullan', 'Affiliation': 'Mayo Clinic, Division of Biomedical Statistics and Informatics, Rochester, Minnesota.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Russi', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Suraj M', 'Initials': 'SM', 'LastName': 'Yalamuri', 'Affiliation': 'Mayo Clinic, Department of Anesthesiology, Rochester, Minnesota.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.7.48574']
2119,32984992,Impact of Abstract Versus Concrete Conceptualization of Genetic Modification (GM) Technology on Public Perceptions.,"Based on the scholarship of abstract/concrete cognition, mental schema, and the integrated model of behavior change, this study found that using concrete over abstract language increased support for specific genetically modified (GM) applications and GM in general, and improved intentions to purchase products containing genetically modified organisms (GMOs). An online survey with an embedded 3 × 2 experiment was conducted using a national sample of U.S. adults (N = 1,470). Participants were randomly assigned to conditions that varied in abstract/concrete conceptualization of GMOs and were prompted to assess GM risk and benefit perceptions with respect to human health and the environment. Regardless of whether they assessed risks or benefits, participants who assessed GMOs through concrete terms compared to abstract terms showed an increase in positive emotions, which in turn increased their support for specific GM applications and GM in general, and their intentions to buy products with GMOs.",2020,Participants were randomly assigned to conditions that varied in abstract/concrete conceptualization of GMOs and were prompted to assess GM risk and benefit perceptions with respect to human health and the environment.,"['national sample of U.S. adults (N = 1,470']",['Abstract Versus Concrete Conceptualization of Genetic Modification (GM) Technology'],['positive emotions'],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0557857', 'cui_str': 'Concrete'}, {'cui': 'C0589138', 'cui_str': 'Conceptualization'}, {'cui': 'C4277689', 'cui_str': 'Gene Editing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",1470.0,0.0535217,Participants were randomly assigned to conditions that varied in abstract/concrete conceptualization of GMOs and were prompted to assess GM risk and benefit perceptions with respect to human health and the environment.,"[{'ForeName': 'Meghnaa', 'Initials': 'M', 'LastName': 'Tallapragada', 'Affiliation': 'Department of Advertising and Public Relations, Klein College of Media and Communication, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hardy', 'Affiliation': 'Department of Communication and Social Influence, Klein College of Media and Communication, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lybrand', 'Affiliation': 'Oak Ridge Institute of Science and Education fellowship program, NIOSH National Personal Protective Technology Laboratory, Centers for Disease Control and Prevention, Pittsburgh, PA, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Hallman', 'Affiliation': 'Department of Human Ecology, School of Environmental & Biological Sciences, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13591']
2120,32970574,Point-of-sale Naloxone: Novel Community-based Research to Identify Naloxone Availability.,"INTRODUCTION


Expanding naloxone availability is important to reduce opioid-related deaths. Recent data suggest low, variable urban naloxone availability. No reports describe naloxone availability at the point of sale (POSN). We characterize POSN without prescription across a Midwestern metropolitan area, via a unique poison center-based study.
METHODS


Pharmacies were randomly sampled within a seven-county metropolitan area, geospatially mapped, and distributed among seven investigators, who visited pharmacies and asked, ""May I purchase naloxone here without a prescription from my doctor?"" Following ""No,"" investigators asked, ""Are you aware of the state statute that allows you to dispense naloxone to the public under a standing order?"" Materials describing statutory support for POSN were provided. Responses were uploaded to REDCap in real time. We excluded specialty (veterinary, mail order, or infusion) pharmacies a priori. POSN availability is presented as descriptive statistics; characteristics of individual sites associated with POSN availability are reported.
RESULTS


In total, 150 pharmacies were prospectively randomized, with 52 subsequently excluded or unavailable for survey. Thus, 98 were included in the final analysis. POSN was available at 71 (72.5%) of 98 pharmacies. POSN availability was more likely at chain than independent pharmacies (84.7% vs 38.5%, p<0.001); rural areas were more commonly served by independent than chain pharmacies (47.4% vs 21.5%, p = 0.022). Five chain and five independent pharmacies (18.5% each) were unaware of state statutory support for collaborative POSN agreements. Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453). Rationale for no POSN varied.
CONCLUSION


POSN is widely available in this metropolitan area. Variability exists between chain and independent pharmacies, and among pharmacies of the same chain; awareness of statutory guidance does not. Poison centers can act to define local POSN availability via direct inquiry in their communities.",2020,"Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453).","['In total, 150 pharmacies were prospectively randomized, with 52 subsequently excluded or unavailable for survey', 'Pharmacies were randomly sampled within a seven-county metropolitan area, geospatially mapped, and distributed among seven investigators, who visited pharmacies and asked, ""May I purchase', 'Midwestern metropolitan area, via a unique poison center-based study']","['Naloxone', 'naloxone here without a prescription from my doctor']","['POSN availability', 'Statutory awareness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",150.0,0.0373328,"Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453).","[{'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Olives', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Willhite', 'Affiliation': 'Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Danika K', 'Initials': 'DK', 'LastName': 'Evans', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jensen', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Hsiao-Ting', 'Initials': 'HT', 'LastName': 'Regelman', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'McGillis', 'Affiliation': 'University of Calgary, Department of Emergency Medicine, Calgary, Alberta, Canada.'}]",The western journal of emergency medicine,['10.5811/westjem.7.2020.47252']
2121,32970583,Creation and Implementation of a Mastery Learning Curriculum for Emergency Department Thoracotomy.,"INTRODUCTION


Emergency department thoracotomy (EDT) is a lifesaving procedure within the scope of practice of emergency physicians. Because EDT is infrequently performed, emergency medicine (EM) residents lack opportunities to develop procedural competency. There is no current mastery learning curriculum for residents to learn EDT. The purpose of this study was to develop and implement a simulation-based mastery learning curriculum to teach and assess EM residents' performance of the EDT.
METHODS


We developed an EDT curriculum using a mastery learning framework. The minimum passing standard (MPS) for a previously developed 22-item checklist was determined using the Mastery Angoff approach. EM residents at a four-year academic EM residency program underwent baseline testing in performing an EDT on a simulation trainer. Performance was scored by two raters using the checklist. Learners then participated in a novel mastery learning EDT curriculum that included an educational video, hands-on instruction, and deliberate practice. After a three-month period, residents then completed initial post testing. Residents who did not meet the minimum passing standard after post testing participated in additional deliberate practice until mastery was obtained. Baseline and post-test scores, and time to completion of the procedure were compared with paired t-tests.
RESULTS


Of 56 eligible EM residents, 54 completed baseline testing. Fifty-two residents completed post-testing until mastery was reached. The minimum passing standard was 91.1%, (21/22 items correct on the checklist). No participants met the MPS at the baseline assessment. After completion of the curriculum, all residents subsequently reached the MPS, with deliberate practice sessions not exceeding 40 minutes. Scores from baseline testing to post-testing significantly improved across all postgraduate years from a mean score of 10.2/22 to 21.4/22 (p <0.001). Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
CONCLUSION


This simulation-based mastery learning curriculum resulted in all residents performing an EDT at a level that met or exceeded the MPS with an overall decrease in time needed to perform the procedure.",2020,"Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
","['EM residents at a four-year academic EM residency program underwent baseline testing in performing an EDT on a simulation trainer', 'Of 56 eligible EM residents, 54 completed baseline testing', 'Emergency Department Thoracotomy']","['Emergency department thoracotomy (EDT', 'Mastery Learning Curriculum']","['Mean time', 'Baseline and post-test scores, and time to completion of the procedure']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",56.0,0.0707255,"Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
","[{'ForeName': 'Danielle T', 'Initials': 'DT', 'LastName': 'Miller', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Hashim Q', 'Initials': 'HQ', 'LastName': 'Zaidi', 'Affiliation': 'University of Chicago School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sista', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, Tennessee.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Dhake', 'Affiliation': 'NorthShore University Health System, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pirotte', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, Tennessee.'}, {'ForeName': 'Abra L', 'Initials': 'AL', 'LastName': 'Fant', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Salzman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.5.46207']
2122,32971179,"High-intensity interval training on body composition, functional capacity and biochemical markers in healthy young versus older people.","BACKGROUND


The aim of the following study was to identify the effects of a 12-week high-intensity interval training (HIIT) program on the modification of parameters of body composition, functional capacity as well as lipid and glucose homeostasis markers in healthy young people versus older adults.
DESIGN


Experimental trial.
METHODS


Healthy young (YNG, 21 ± 1 years, BMI 26.01 ± 2.64 kg·m -2 , n = 10) and older (OLD, 66 ± 5 years, BMI 27.43 ± 3.11 kg·m -2 , n = 10) males were subjected to 12 weeks of HIIT. Prior to and immediately after the HIIT program, dual-energy X-ray absorptiometry, dominant leg strength one-repetition maximum (1-RM), maximal oxygen uptake (VO 2max ) and physical performance tests were performed. Blood samples were also taken.
RESULTS


Flexibility (P = 0.000), static balance (P = 0.004), timed up and go test (TUG) (P = 0.015), short physical performance battery (SPPB) (P = 0.005), dominant leg strength 1-RM (P = 0.012), and VO 2max  (P = 0.000) were better in YNG versus OLD. HIIT improved the % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), dominant leg strength 1-RM (P = 0.025), VO 2max  (P = 0.000), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006). TUG was improved by the training only in the OLD group (P = 0.016), but insulin (P = 0.002) and the homeostasis model assessment - insulin sensitivity (HOMA-IS) (P = 0.000) decreased only in the YNG group. HOMA-IS was correlated positive with BMI (R = 0.474, P = 0.035) and with whole-body fat mass (R = 0.517, P = 0.019).
CONCLUSIONS


HIIT for 12 weeks improves parameters of body composition, functional capacity and fasting serum lipid and glucose homeostasis markers in healthy young and older participants. Young people are shown as benefiting more.",2020,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","['Healthy young (YNG, 21\u202f±\u202f1\u202fyears, BMI 26.01\u202f±\u202f2.64, n\u202f=\u202f10) and older (OLD, 66\u202f±\u202f5\u202fyears, BMI 27.43\u202f±\u202f3.11, n\u202f=\u202f10) males', 'healthy young and older participants', 'healthy young versus older people', 'healthy young people vs older adults']","['high-intensity interval training (HIIT) program', 'High-intensity interval training']","['homeostasis model assessment - insulin sensitivity (HOMA-IS', 'HOMA-IS', 'repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests', 'TUG', 'static balance', 'body composition, functional capacity and biochemical markers', 'body composition, functional capacity and fasting serum lipid and glucose homeostasis markers', 'Flexibility', 'leg lean mass', 'body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers', 'timed up and go test (TUG', '1-RM dominant leg strength', 'physical performance', 'VO 2max', 'fasting cholesterol', 'fasting glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0125358,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","[{'ForeName': 'Gabriel Nasri', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. Electronic address: gabriel.marzuca@ufrontera.cl.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Artigas-Arias', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Olea', 'Affiliation': 'Departamento de Educación Física, Deporte y Recreación, Facultad de Educación, Ciencias Sociales y Humanidades, Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'SanMartín-Calísto', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nolberto', 'Initials': 'N', 'LastName': 'Huard', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Durán-Vejar', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beltrán-Fuentes', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alegría-Molina', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sapunar', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Salazar', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}]",Experimental gerontology,['10.1016/j.exger.2020.111096']
2123,32971262,Another's pain in my brain: No evidence that placebo analgesia affects the sensory-discriminative component in empathy for pain.,"The shared representations account of empathy suggests that sharing other people's emotions relies on neural processes similar to those engaged when directly experiencing such emotions. Recent research corroborated this by showing that placebo analgesia induced for first-hand pain resulted in reduced pain empathy and decreased activation in shared neural networks. However, those studies did not report any placebo-related variation of somatosensory engagement during pain empathy. The experimental paradigms used in these studies did not direct attention towards a specific body part in pain, which may explain the absence of effects for somatosensation. The main objective of this preregistered study was to implement a paradigm overcoming this limitation, and to investigate whether placebo analgesia may also modulate the sensory-discriminative component of empathy for pain. We induced a localized, first-hand placebo analgesia effect in the right hand of 45 participants by means of a placebo gel and conditioning techniques, and compared this to the left hand as a control condition. Participants underwent a pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation. In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses. We thus report no evidence for somatosensory sharing in empathy, while replicating previous studies showing overlapping brain activity in the affective-motivational component for first-hand and empathy for pain. Hence, in a more rigorous test aiming to overcome limitations of previous work, we again find no causal evidence for the engagement of somatosensory sharing in empathy. Our study refines the understanding of the neural underpinnings of empathy for pain, and the use of placebo analgesia in investigating such models.",2020,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[""Another's pain in my brain"", '45 participants by means of a']","['placebo', 'pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation', 'placebo gel and conditioning techniques']","['behavioral nor neural responses', 'pain empathy']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",45.0,0.195586,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Riva', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117397']
2124,32971449,"Effects of a nurse-led positive psychology intervention on sexual function, depression and subjective well-being in postoperative patients with early-stage cervical cancer: A randomized controlled trial.","BACKGROUND


Sexual dysfunction is a common long-term complication of cervical cancer and its treatment. However, due to traditional Chinese culture, there are few studies on interventions to improve sexual function in China.
OBJECTIVES


To evaluate the effectiveness of a nurse-led positive psychology intervention on sexual function, depression and subjective well-being amongst postoperative patients with early-stage cervical cancer.
DESIGN


A randomized controlled trial.
SETTINGS AND METHODS


Patients who had undergone radical hysterectomy for early-stage cervical cancer and were followed up in gynaecological clinics were recruited via convenience sampling from three tertiary hospitals in Chongqing, China. Patients who met the inclusion criteria and agreed to participate (N = 91) were randomly assigned to a nurse-led positive psychology intervention (intervention group, n = 46) or usual care (control group, n = 45). The Female Sexual Function Index, Self-rating Depression Scale and Index of Well-being were used to assess sexual function, depression and subjective well-being, respectively, at baseline and 3 and 6 months after the intervention. Data were analysed by the chi-square test, Mann-Whitney U test, t-test and Pearson correlation analysis.
RESULTS


Compared with participants in the control group, participants in the intervention group showed significant improvements in sexual function (mean difference [MD]: -3.95, P = 0.005 at 3 months post-intervention; MD: -4.36, P = 0.001 at 6 months post-intervention). In addition, at 3 and 6 months after the intervention, the number of patients with improvements in their levels of depression and well-being in the intervention group was higher than that in the control group (P<0.05). The Pearson correlation analysis results showed that there was a negative correlation between sexual function and level of depression in patients (r =-0.612, P<0.001) and that sexual function was positively correlated with subjective well-being (r = 0.638, P<0.001).
CONCLUSION


The intervention group experienced significant improvements in sexual function, depression and subjective well-being. These findings suggest that a nurse-led positive psychology intervention should be implemented for postoperative patients with early-stage cervical cancer.",2020,"The intervention group experienced significant improvements in sexual function, depression and subjective well-being.","['postoperative patients with early-stage cervical cancer', 'Patients who met the inclusion criteria and agreed to participate (N\xa0=\xa091', 'Patients who had undergone radical hysterectomy for early-stage cervical cancer and were followed up in gynaecological clinics were recruited via convenience sampling from three tertiary hospitals in Chongqing, China']","['nurse-led positive psychology intervention', 'nurse-led positive psychology intervention (intervention group, n\xa0=\xa046) or usual care (control group, n\xa0=\xa045']","['sexual function and level of depression', 'sexual function', 'Female Sexual Function Index, Self-rating Depression Scale and Index of Well-being', 'sexual function, depression and subjective well-being']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",91.0,0.084043,"The intervention group experienced significant improvements in sexual function, depression and subjective well-being.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecology, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecology, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Army Military Medical University, No.30 Gaotanyan Main Street, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Xiuni', 'Initials': 'X', 'LastName': 'Gan', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China. Electronic address: ganxn@163.com.'}, {'ForeName': 'Xiuying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Radiology Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China. Electronic address: 851720412@qq.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103768']
2125,32971450,Improving the endothelial dysfunction in type 2 diabetes with chromium and vitamin D 3  byreducing homocysteine and oxidative stress: A randomized placebo-controlled trial.,"BACKGROUND


Chromium picolinate (CrPic) and vitamin D3 are known as two antioxidant micronutrients. Through inducing endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA) lead to cardiovascular disease in type 2 diabetes mellitus (T2DM). No published data has directly examined the effects of these two antioxidants on improving the endothelial dysfunction in T2DM throughreducing homocysteine and oxidative stress.
METHODS


Subjects (n = 92) in this randomized, double blind, placebo-control study were randomly assigned to receive oral placebo (group I), D 3  (group II: 50,000 IU/ week), chromium picolinate (CrPic) (group III: 500 μg/day), and both vitamin D 3  and CrPic (group IV) for four months. Fasting blood samples were drawn at study baseline and following intervention to determine Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule- 1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1).
RESULTS


After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
CONCLUSION


Our findings suggest that through reducing homocysteine and oxidative stress and improving endothelial dysfunction, chromium and vitamin D 3  co-supplementation might be predictive and preventive of cardiovascular diseasesassociated with T2DM. IRCT, IRCT20190610043852N1, registered 21 October 2019, https://fa.irct.ir/user/trial/42293/view.",2020,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","['Subjects (n = 92', 'type 2 diabetes mellitus (T2DM']","['chromium and vitamin D', 'vitamin D 3  and CrPic', 'Chromium picolinate (CrPic) and vitamin D3', 'oral placebo', 'placebo', 'chromium picolinate (CrPic']","['MDA', 'VCAM-1', 'Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule', 'endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA', 'Fasting blood samples', '1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1', 'homocysteine and oxidative stress', 'endothelial dysfunction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.150688,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Imanparast', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran; Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran. Electronic address: Fatemeh.Imanparast@arakmu.ac.ir.'}, {'ForeName': 'Farideh Jalali', 'Initials': 'FJ', 'LastName': 'Mashayekhi', 'Affiliation': 'Department of Biochemistry and Genetics, Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran; Department of Laboratory Sciences, Faculty of Paramedicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kamankesh', 'Affiliation': 'Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Mohaghegh', 'Affiliation': 'Community and Preventive Medicine Specialist, Department of community medicine, Faculty of Medicine, Arak University of Medical Sciences, Arak,Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alimoradian', 'Affiliation': 'Department of Pharmacology, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126639']
2126,32973577,A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.,"Background


Opioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).
Methods


We used a randomized, double blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm 2 , 60 J/cm 2 , 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up.
Results


Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed.
Discussion


Unilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.",2020,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.",['22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions'],"['unilateral transcranial photobiomodulation (t-PBM', 'placebo', 'unilateral t-PBM applications']","['abdominal bloating', 'OCS', 'positive hemispheric emotional valence', 'weekly Hamilton Depression (HDRS) and Anxiety (HARS', 'adverse effects', 'opioid craving scale (OCS', 'HDRS', 'HARS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",22.0,0.301561,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.","[{'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Schiffer', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Reichmann', 'Affiliation': 'Independent Consultant, Danvers, MA, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Flynn', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McCormack', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00827']
2127,32974838,"Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A.","An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUC norm  was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 ( ClinicalTrials.gov identifier). Date of registration: July 9, 2019.",2020,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"['Adult patients (N = 18) with severe hemophilia A', 'patients with severe hemophilia A', 'patients with hemophilia A']","['damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII ', 'two extended half-life PEGylated recombinant FVIII products']","['geometric mean (coefficient of variation [%CV', 'FVIII activity', 'PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C4723219', 'cui_str': 'damoctocog alfa pegol'}, {'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",18.0,0.109307,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Pharmaceuticals Research & Development, Bayer AG, 13353, Berlin, Germany. alexander.solms@bayer.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berntorp', 'Affiliation': 'Centre for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Iorio', 'Affiliation': 'McMaster-Bayer Endowed Research Chair in Clinical Epidemiology of Congenital Bleeding Disorders, Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Linardi', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Ahsman', 'Affiliation': 'LAP&P Consultants BV, Leiden, the Netherlands.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Tihomir', 'Initials': 'T', 'LastName': 'Zhivkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}, {'ForeName': 'Toshko', 'Initials': 'T', 'LastName': 'Lissitchkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}]",Annals of hematology,['10.1007/s00277-020-04280-3']
2128,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION


A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES


and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS


46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23 mC to 22.4 mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION


It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University, General University Hospital in Prague, Czech Republic.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
2129,32978539,Does personalised text messaging influence patients' caries risk?,"Design A single-blinded, randomised controlled trial. The experimental group received 24 personalised text messages each week, disseminating tailored preventive advice using the multifactorial model for individual caries risk assessment: Cariogram. The same frequency of text messaging was delivered to the control group; however, these were non-personalised messages and did not factor the Cariogram.Sample selection One hundred and ninety-one participants were assessed for eligibility by eight calibrated, volunteer dental practitioners in County Cork, Ireland. Six different inclusion criteria were detailed, including the requirement for medical card holders, serving as an indicator for economically underprivileged status. Other criteria included: aged between 19-70 years; competent with text messaging services; have a minimum of 20 teeth present; not pregnant; and prepared to give consent. Failure to return a baseline food diary or possess a mobile phone saw the exclusion of 20 participants. Following stratified and blocked randomisation, 85 and 86 participants were allocated in the test and control group, respectively. The study received ethical approval by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.Data analysis One hundred and eleven participants attended the follow-up examination, 26 weeks after randomisation, where the 'chance of avoiding new cavities' was determined as a numerical index for caries risk. The secondary aim was to measure individual changes to seven Cariogram risk factors between the baseline assessment and the re-examination. The ANCOVA intention-to-threat (ITT) protocol and the per-protocol method were adhered to for analyses of outcome measures. Statistical analysis was performed using SAS 9.4, in adherence to a pre-defined significance level of 5% (two-sided).Results Both analytic techniques confirmed no statistically significant difference (p >0.05) between the groups regarding the 'chance of avoiding new cavities'. Of the risk parameters assessed, only saliva secretion demonstrated a positive effect in the intervention group (p = 0.036, OR = 0.3, 95% CI = 0.1, 0.9). Predictive modelling techniques were not reliable due to the limited sample size of per-protocol analysis.Conclusions The failure to conclude statistical significance between the groups validates the null hypothesis. Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland. The authors address the value of further studies exploring the potential for caries risk reduction through mobile phone communications.",2020,"Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland.","['Other criteria included: aged between 19-70 years; competent with', 'Sample selection One hundred and ninety-one participants were assessed for eligibility by eight calibrated, volunteer dental practitioners in County Cork, Ireland']","['text messaging services', 'personalised text messaging', '24 personalised text messages each week, disseminating tailored preventive advice using the multifactorial model for individual caries risk assessment: Cariogram']",['saliva secretion'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0304066', 'cui_str': 'Cork'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}]",191.0,0.122159,"Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Health, University of Leeds, Leeds, UK. dn18jyp@leeds.ac.uk.'}]",Evidence-based dentistry,['10.1038/s41432-020-0109-3']
2130,32979860,Fusidic acid cream comparatively minimizes signs of inflammation and postinflammatory hyperpigmentation after ablative fractional CO 2  laser resurfacing in Chinese patients: A randomized controlled trial.,"BACKGROUND


Inflammation and postinflammatory hyperpigmentation (PIH) are two adverse side effects of ablative fractional CO 2  laser (ablative Fr CO 2  ) treatment for both rejuvenation and acne scars.
AIMS


To evaluate the efficacy of fusidic acid cream versus erythromycin ointment as postoperative therapy in patients who underwent ablative Fr CO 2  treatment for atrophic acne scars.
METHODS


Sixty Chinese patients who fulfilled the study criteria were recruited and randomly assigned to an experimental group treated with fusidic acid cream or a control group treated with erythromycin ointment. Postoperative treatment lasted for 7 days in each group. Each patient had two follow-up visits at 8 and 12 weeks. In total, three patients dropped out of the study, one in the experimental group at week 8 and two in the control group at weeks 8 and 12. Baseline and postoperative inflammation and PIH were assessed by facial examination, photographs, and questionnaires. Besides, PIH was evaluated by the Hyperpigmentation Activity and Severity Index (HASI) and a five-point grading system.
RESULTS


Moderate-to-severe PIH was observed in both groups. However, the mean HASI score and severity of PIH in the experimental group were lower than those of the control group at weeks 8 and 12 (P < 0.05). In the control group, one patient developed postoperative abscesses and one had papules, whereas no inflammation was observed in the experimental group participants.
CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative Fr CO 2  therapy to reduce postoperative inflammation and PIH.",2020,"CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative FrCO 2  therapy to reduce postoperative inflammation and PIH.","['Sixty Chinese patients who fulfilled the study criteria', 'Chinese patients', 'patients who underwent ablative Fr CO 2  treatment for atrophic acne scars']","['Fusidic acid cream', 'erythromycin ointment', 'fusidic acid cream']","['Hyperpigmentation Activity and Severity Index (HASI', 'Moderate to severe PIH', 'postoperative abscesses', 'mean HASI score and severity of PIH', 'no inflammation', 'Baseline and postoperative inflammation and PIH']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C0016875', 'cui_str': 'fusidic acid'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1248462', 'cui_str': 'Erythromycin Topical Ointment'}]","[{'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0919914', 'cui_str': 'Postoperative abscess'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",60.0,0.0210102,"CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative FrCO 2  therapy to reduce postoperative inflammation and PIH.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiao Feng', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Mengna', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Baoxi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13735']
2131,32972265,Effect of dexmedetomidine for sedation and cognitive function in patients with preoperative anxiety undergoing carotid artery stenting.,"OBJECTIVE


This study was performed to examine the effect of dexmedetomidine for intraoperative sedation and postoperative cognitive function in patients with preoperative anxiety undergoing carotid artery stenting.
METHODS


Eighty patients were randomly divided into two groups: the dexmedetomidine group and the control group. Cognitive function was assessed using the Mini-Mental State Examination (MMSE). Anxiety was evaluated using the Amsterdam Preoperative Anxiety and Information Scale. Routine monitoring indices were recorded during surgery, and cognitive function indices were recorded before drug infusion (T 0 ), 10 minutes after drug infusion (T 1 ), at the end of surgery (T 2 ), and 6 hours after surgery (T 3 ).
RESULTS


The anxiety scores were not significantly different between the two groups at T0, but they became significantly different at T 1-3 . The MMSE scores in both groups increased at 1 and 7 days postoperatively; although the increase in the dexmedetomidine group was sharper, there was no significant difference. In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
CONCLUSION


Dexmedetomidine can improve patients' anxiety and achieve a sufficient sedation effect without causing postoperative cognitive dysfunction.",2020,"In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
","['Eighty patients', 'patients with preoperative anxiety undergoing carotid artery stenting']","['Dexmedetomidine', 'dexmedetomidine']","['Mini-Mental State Examination (MMSE', 'anxiety scores', 'Cognitive function', 'Amsterdam Preoperative Anxiety and Information Scale', 'Anxiety', 'MMSE scores']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",80.0,0.0313329,"In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
","[{'ForeName': 'Liu-Ping', 'Initials': 'LP', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong City, Jiangsu, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Kang', 'Affiliation': 'Department of Geriatrics, Yidu Central Hospital of Weifang, Weifang, Shandong, China.'}]",The Journal of international medical research,['10.1177/0300060520938959']
2132,32972965,Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.,"BACKGROUND


Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.
METHODS


This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters.
FINDINGS


A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
INTERPRETATION


Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.
TRIAL REGISTRATION NUMBER


The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).",2020,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","['five districts in India', 'sick neonates and young infants using']","['routine health services', 'oral and injectable antibiotics and community mobilisation', 'home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW', 'home-based newborn care']","['proportion of facility births', 'risk of neonatal mortality', 'neonatal and infant mortality rates', 'neonatal mortality', 'Baseline mortality rates', 'risks of early neonatal mortality, young infant mortality and infant mortality', 'risks of neonatal, early neonatal, young infant, infant mortality', 'neonatal and young infant mortality rates', 'neonatal and infant mortality']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0793595,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Rasaily', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India reeta.rasaily@gmail.com.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Saxena', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Pandey', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Bishan S', 'Initials': 'BS', 'LastName': 'Garg', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Saraswati', 'Initials': 'S', 'LastName': 'Swain', 'Affiliation': 'National Institute of Applied Human Research & Development (NIAHRD), Cuttack, India.'}, {'ForeName': 'Sharad D', 'Initials': 'SD', 'LastName': 'Iyengar', 'Affiliation': 'Action Research and Training for Health (ARTH), Udaipur, India.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Das', 'Affiliation': 'King George Medical University (KGMU), Lucknow, India.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'National Institute of Medical Statistics, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Harshpal Singh', 'Initials': 'HS', 'LastName': 'Sachdev', 'Affiliation': 'Sitaram Bhartia Institute of Science and Research (SBISR), New Delhi, India.'}, {'ForeName': 'Mari Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddarth', 'Initials': 'S', 'LastName': 'Ramji', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Abhay T', 'Initials': 'AT', 'LastName': 'Bang', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Gadchiroli, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ global health,['10.1136/bmjgh-2017-000680']
2133,32973056,"Effectiveness of three-dimensional printed and virtual reality models in learning the morphology of craniovertebral junction deformities: a multicentre, randomised controlled study.","OBJECTIVES


To compare the effectiveness of three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models in clinical education regarding the morphology of craniovertebral junction (CVJ) deformities.
DESIGN


Prospective, multicentre, randomised controlled study.
SETTING


Three teaching hospitals in China.
PARTICIPANTS


One hundred and fifty-three participants in their first year of a 3-year medical residency programme.
INTERVENTIONS


All participants were randomised to one of the three groups to learn the morphology of CVJ deformities using 3DP, VR or NP models.
PRIMARY OUTCOME MEASURES


The objective outcomes were evaluated using three-level objective testing. In the first-level test, the participants were required to identify 15 anatomical landmarks on radiographs without CVJ deformities. In the second-level test, all participants were asked to identify the same 15 landmarks on radiographs showing classic CVJ deformities. In the third-level test, the participants were required to describe the key features of three classic cases of CVJ deformities depicted on radiographs. Each participant was also asked to answer four subjective questions to evaluate the importance and usefulness of the educational materials.
RESULTS


In the first-level test, the 3DP, VR and NP groups achieved similar correct rates. In the second-level test, the correct rate was higher in the 3DP group (82.1%±13.6%) than the VR and NP groups (76.9%±16.9% and 69.9%±20.0%, p=0.002). In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups. The subjective tests showed that the 3DP model method was considered the most valuable approach for learning CVJ deformities.
CONCLUSIONS


The objective and subjective results show that the 3DP model is more effective teaching instrument than the NP model for learning the pathomorphology of CVJ deformities. The VR model also showed great efficacy, second to 3DP model, in improving participants' understanding of CVJ deformities.",2020,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","['craniovertebral junction deformities', 'One hundred and fifty-three participants in their first year of a 3-year medical residency programme', 'Three teaching hospitals in China']","['CVJ deformities using 3DP, VR or NP models', 'three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models', 'three-dimensional printed and virtual reality models']","['CVJ deformities features', 'correct rate']","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035184', 'cui_str': 'Medical Residency'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",153.0,0.0288685,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Plastic Surgery Hospital and Institute, Shijingshan District, Beijing, China.'}, {'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Orthopedic Surgery, Shanghai Jiaotong University Affiliated Sixth People Hospital South Campus, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China tianye2019trail@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036853']
2134,32973057,Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.,"INTRODUCTION


Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.
METHODS AND ANALYSIS


This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.
ETHICS AND DISSEMINATION


This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000028726).",2020,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"['patients with heart failure and LBBB', 'heart failure patients with left bundle branch block (LBBB', 'heart failure patients with left bundle branch block', 'From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study', 'cardiac centre of Beijing Anzhen Hospital']","['left bundle branch area pacing versus biventricular pacing', 'Left bundle branch area pacing (LBBaP', 'LBBaP']","['LVEF', 'Efficacy and safety', 'NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C0006384', 'cui_str': 'Bundle branch block'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429097', 'cui_str': 'QRS complex feature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011008', 'cui_str': 'Date'}]",,0.205921,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"[{'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Junmeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zefeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mengge', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, Beijing Anzhen Hospital, Capital Medical University, the Key Laboratory of Remodeling-Related Cardiovascular Diseases, Ministry of Education, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China wuyongquan67@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036972']
2135,32976085,High-flow nasal oxygen reduces endotracheal intubation: a randomized clinical trial.,"BACKGROUND


The benefits of high-flow nasal cannula (HFNC) as primary intervention in patients with acute hypoxemic respiratory failure (AHRF) are still a matter in debate. Our objective was to compare HFNC therapy  versus  conventional oxygen therapy (COT) in the prevention of endotracheal intubation in this group of patients.
METHODS


An open-label, controlled and single-centre clinical trial was conducted in patients with severe AHRF, defined by a PaO 2 /FIO 2  ratio ⩽200, to compare HFNC with a control group (CG) treated by COT delivered through a face mask, with the need to perform intubation as the primary outcome. The secondary outcomes included tolerance of the HFNC device and to look for the predictive factors for intubation in these patients.
RESULTS


A total of 46 patients were included (22 in the COT group and 24 in the HFNC group) 48% of whom needed intubation: 63% in the COT group and 33% in the HFNC group, with significant differences both in intention to treat [χ 2  = 4.2;  p  = 0.04, relative risk (RR) = 0.5; confidence interval (CI) 95%: 0.3-1.0] and also in treatment analysis (χ 2  = 4.7;  p  = 0.03; RR = 0.5; IC 95%: 0.3-0.9) We obtained a number needed to treat (NNT) = 3 patients treated to avoid an intubation. Intubation occurred significantly later in the HFNC group. Estimated PaO 2 /FIO 2 , respiratory rate and dyspnea were significantly better in the HFNC group. Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients. Mortality was 22% with no differences. The HFNC group patients were hospitalized for almost half of the time in the intensive care unit (ICU) and in the ward, with significantly less hospital length of stay. A total of 14 patients in the HFNC group (58%) complained of excessive heat and 17% of noise; 3 patients did not tolerate HFNC.
CONCLUSION


Patients with severe acute hypoxemic respiratory failure who tolerate HFNC present a significantly lower need for endotracheal intubation compared with conventional oxygen therapy.
CLINICAL TRIAL REGISTER


EUDRA CT number: 2012-001671-36 The reviews of this paper are available via the supplemental material section.",2020,"Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients.","['patients with severe AHRF, defined by a PaO 2 /FIO 2  ratio ⩽200, to compare HFNC with a control group (CG) treated by', '14 patients in the HFNC group (58', 'patients with acute hypoxemic respiratory failure (AHRF', 'Patients with severe acute hypoxemic respiratory failure']","['COT', 'High-flow nasal oxygen reduces endotracheal intubation', 'conventional oxygen therapy', 'HFNC therapy  versus  conventional oxygen therapy (COT', 'HFNC', 'high-flow nasal cannula (HFNC']","['Mortality', 'complained of excessive heat', 'Estimated PaO 2 /FIO 2 , respiratory rate and dyspnea', 'endotracheal intubation', 'hospital length of stay', 'Intubation', 'tolerance of the HFNC device and to look for the predictive factors for intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0183644', 'cui_str': 'Trolley'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",46.0,0.295594,"Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Andino', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Diego de León 62, Madrid, 28006, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Vega', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Sandra Karina', 'Initials': 'SK', 'LastName': 'Pacheco', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Arevalillo', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Leal', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fernández', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Rodriguez', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620956459']
2136,32976120,Three-Dimensional-Printed Liver Model Helps Learners Identify Hepatic Subsegments: A Randomized-Controlled Cross-Over Trial.,"INTRODUCTION


The purpose of this study was to find out whether 3-dimensional (3D)-printed models improved the learners' ability to identify liver segments.
METHODS


A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images. Adjusted multilevel-mixed models were used to compare scores at baseline and after 3D and 2D.
RESULTS


Accuracy in identifying hepatic segments was higher with 3D first than 2D (77% vs 69%; P = 0.05) and not significantly improved by a combination of 3D and 2D. Increased confidence in segment identification was highest in trainees after 3D (P = 0.04).
DISCUSSION


3D-printed models facilitate learning hepatic segmental anatomy.",2020,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,['A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images'],[],['confidence in segment identification'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",116.0,0.0489261,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,"[{'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Chedid', 'Affiliation': '1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA; 2Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA; 3Mayo Clinic Center for Clinical and Translational Science, Mayo Clinic, Rochester, Minnesota, USA; 4Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA; 5Division of Transplantation Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Amika A', 'Initials': 'AA', 'LastName': 'Kamath', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'M Knudsen', 'Affiliation': ''}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Frimannsdottir', 'Affiliation': ''}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'R Geske', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Taner', 'Affiliation': ''}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Matsumoto', 'Affiliation': ''}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': ''}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000958']
2137,32976204,Effect of two different pre-operative exercise training regimens before colorectal surgery on functional capacity: A randomised controlled trial.,"BACKGROUND


Multimodal prehabilitation, including exercise training, nutritional therapy and anxiety reduction, has been shown to attenuate functional decline associated with surgery. Due to the growing interest in functional status as a targeted surgical outcome, a better understanding of the optimal prescription of exercise is critical.
OBJECTIVE


The objective is to compare peri-operative functional trajectory in response to two different exercise training protocols within a 4-week, supervised, multimodal prehabilitation programme.
DESIGN


This was a single blinded, single centre, randomised controlled study. Participants performed four assessments: at baseline, after prehabilitation (just before surgery), and at 1 and 2 months after surgery.
PATIENTS


Adult patients scheduled for elective resection of nonmetastatic colorectal cancer were included provided there were no absolute contraindications to exercise nor poor language comprehension.
INTERVENTION


Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT), as part of a 4-week multimodal prehabilitation programme. Both groups followed the same supervised resistance training, nutritional therapy and anxiety reduction interventions. All patients followed standardised peri-operative management.
MAIN OUTCOME MEASURE


Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing, were assessed and compared between groups.
RESULTS


Forty two patients were included in the primary analysis (HIIT n = 21 vs. MICT n = 21), with mean ± SD age 64.5 ± 11.2 years and 62% were men. At 2 months after surgery, 13/21 (62%) in HIIT and 11/21 (52%) in MICT attended the study visits. Both protocols significantly enhanced pre-operative functional capacity, with no difference between groups: mean (95% confidence interval) oxygen consumption at anaerobic threshold 1.97 (0.75 to 3.19) ml kg min in HIIT vs. 1.71 (0.56 to 2.85) in MICT, P = 0.753. At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ml kg min, P = 0.021. No adverse events occurred during the intervention.
CONCLUSION


Both MICT and HIIT enhanced pre-operative functional capacity.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03361150.",2020,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","['Adult patients scheduled for elective resection of nonmetastatic colorectal cancer', 'Forty', 'two patients were included in the primary analysis (HIIT n\u200a=\u200a21 vs. MICT n\u200a=\u200a21), with mean\u200a±\u200aSD age 64.5\u200a±\u200a11.2 years and 62% were men']","['Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT', 'pre-operative exercise training regimens', 'supervised resistance training, nutritional therapy and anxiety reduction interventions']","['adverse events', 'oxygen consumption', 'physical fitness', 'pre-operative functional capacity', 'Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing', 'functional capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",42.0,0.0783114,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","[{'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'From the Department of Anesthesia, McGill University Health Centre, Montreal General Hospital, (EMM, VF, RA, CS-B, FC), Department of Kinesiology and Physical Education, McGill University, (VF, CS-B), Department of Surgery, (PC, BS, ASL) and Division of Geriatric Medicine, McGill University Health Centre, Montreal General Hospital, Montreal, Quebec, Canada (JAM).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': ''}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': ''}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': ''}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001215']
2138,32979515,A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial.,"Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.",2020,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","['community dwelling adults with ADRD and their caregivers', ""Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA"", 'adults with ADRD randomized to', ""adults with Alzheimer's disease and their caregivers"", '100 community dwelling adults with ADRD and their caregiver', 'adults with ADRD and their caregivers randomized to', 'adults with ADRD and their caregivers (RGV', 'adults with ADRD and their caregiver across 18 mos']","['remote physical activity intervention', 'RGV or EUC', 'RGV approach with usual care, enhanced with caregiver support (EUC', 'RGV or ECU']","['MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",100.0,0.092155,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: evidoni@kumc.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@ku.edu.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Helsel', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: bhelsel@kumc.edu.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: kwilliams1@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106158']
2139,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2020,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Diagnostic Imaging, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
2140,32979620,"Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Although massive bleeding following transbronchial lung biopsies (TBLB) is rare, even minor hemorrhage may prolong the procedure and result in inadequate sampling. Tranexamic acid (TXA) is an antifibrinolytic agent, which reduces bleeding in numerous scenarios, however, its prophylactic use in mitigating post-TBLB bleeding has not been investigated. We conducted a prospective, randomized, double-blind, placebo-controlled trial to determine whether topical infusion of TXA prior to TBLB would reduce bleeding, shorten procedure duration and increase the number of biopsies obtained.
METHODS


We blindly randomized patients undergoing TBLB to receive topical TXA or placebo in the lobar bronchus prior to biopsies. Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained were measured. Data was analyzed using the two-tailed Student's T-Test, Chi-square or Mann-Whitney tests as appropriate.
RESULTS


Fifty patients were randomized, 26 to the TXA arm. The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90). There were no clinically significant adverse events in any of the groups up to one month of follow up.
CONCLUSION


Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events. The prophylactic use of TXA during TBLB may be considered as standard.",2020,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","['We blindly randomized patients undergoing TBLB to receive', 'Fifty patients were randomized, 26 to the TXA arm']","['Tranexamic acid (TXA', 'topical TXA or placebo', 'tranexamic acid', 'placebo', 'TXA']","['number of biopsies obtained', 'adverse events', 'procedure length', ""Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained"", 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.616386,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","[{'ForeName': 'Rottem', 'Initials': 'R', 'LastName': 'Kuint', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: kuint@hadassah.org.il.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Institute of Pulmonary Medicine, Chaim Sheba Medical Center, The Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Cohen Goichman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Huszti', 'Affiliation': 'Biostatistics Research Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abu Rmeileh', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Shriki', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Zvi G', 'Initials': 'ZG', 'LastName': 'Fridlender', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Berkman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106162']
2141,32979635,Endothelial shear stress and vascular remodeling in bioresorbable scaffold and metallic stent.,"BACKGROUND AND AIMS


The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up.
METHODS


In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks.
RESULTS


Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Post-procedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling.
CONCLUSIONS


In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.",2020,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.",[],"['bioresorbable scaffold (BRS', 'endothelial shear stress (ESS']",['Endothelial shear stress and vascular remodeling'],[],"[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3850148', 'cui_str': 'Vascular Remodeling'}]",,0.0802054,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Tenekecioglu', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Bellvitge University Ho^spital, Barcelona, Spain.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Hopital de Rangueil, Toulouse, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Rinse', 'Initials': 'R', 'LastName': 'Johannes van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'S Maria University Hospital, Terni, Italy.'}, {'ForeName': 'Ad J van', 'Initials': 'AJV', 'LastName': 'Boven', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'Biomédiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Bristol Heart Institute, Bristol, United Kingdom.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Kitslaar', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ural', 'Affiliation': 'Department of Cardiology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Pekkan', 'Affiliation': 'Department of Mechanical Engineering, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, University College of London Hospitals, London, United Kingdom; Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gijsen', 'Affiliation': 'Department of Biomedical Engineering, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London, United Kingdom.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, London, United Kingdom; Department of cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.031']
2142,32980142,"[The effect of epinephrine for the treatment of spinal-hypotension: comparison with norepinephrine and phenylephrine, clinical trial].","BACKGROUND AND OBJECTIVES


Limited data are present on safety and efficiency of epinephrine for the prophylaxis and treatment of spinal-hypotension. This study was conducted to compare the effect of epinephrine with norepinephrine and phenylephrine on the treatment of spinal-hypotension and ephedrine requirement during cesarean delivery.
METHODS


One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited. They were allocated randomly to receive norepinephrine 5 μg.mL -1  (n=40), epinephrine 5 μg.mL -1  (n=40), phenylephrine 100 μg.mL -1  (n=40) or 0.9% saline infusions (n=40) immediately after induction of spinal anesthesia. Whenever systolic blood pressure drops to less than 80% of baseline, 5 mg of iv ephedrine was administered as rescue vasopressor. The incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects were recorded.
RESULTS


There was no statistically significant difference in incidence of maternal hypotension between groups. The number of patients requiring ephedrine was significantly greater in group saline than in group phenylephrine (p <0.001). However, it was similar between phenylephrine, norepinephrine, and epinephrine groups. The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
CONCLUSION


There is no statistically significant difference in incidence of hypotension and ephedrine consumption during spinal anesthesia for cesarean delivery with the use of epinephrine when compared to norepinephrine or phenylephrine. Epinephrine can be considered as an alternative agent for management of spinal hypotension.",2020,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","['spinal-hypotension', 'One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited']","['epinephrine', 'phenylephrine, norepinephrine', 'norepinephrine, epinephrine, phenylephrine', 'ephedrine', 'Epinephrine', 'norepinephrine or phenylephrine', 'epinephrine with norepinephrine and phenylephrine', 'epinephrine 5\xa0μg.mL -1', 'norepinephrine and phenylephrine', 'phenylephrine 100\xa0μg.mL -1  (n=40) or 0.9% saline infusions', 'phenylephrine', 'norepinephrine\xa05\xa0μg.mL -1']","['hypotension and ephedrine consumption', 'incidence of maternal hypotension', 'number of patients requiring ephedrine', 'mean ephedrine consumption', 'incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects', 'systolic blood pressure drops']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",160.0,0.351953,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Biricik', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turkey. Electronic address: ebrubiricik01@gmail.com.'}, {'ForeName': 'Feride', 'Initials': 'F', 'LastName': 'Karacaer', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turkey.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Ünal', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Statistics, Adana, Turkey.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Sucu', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Obstetrics and Gynecology, Adana, Turkey.'}, {'ForeName': 'Hakkı', 'Initials': 'H', 'LastName': 'Ünlügenç', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turkey.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.017']
2143,32980725,Radiomic features of magnetic resonance images as novel preoperative predictive factors of bone invasion in meningiomas.,"PURPOSE


Bone invasion in meningiomas is a prognostic determinant, and a priori knowledge may alter surgical techniques. Here, we aim to predict bone invasion in meningiomas using radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI).
METHODS


In this retrospective study, 490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion. The patients were randomly divided into training (n = 343) and test (n = 147) datasets at a 7:3 ratio. For each patient, 1227 radiomic features were extracted from T1C and T2, respectively. Spearman's correlation and least absolute shrinkage and selection operator (LASSO) regression analyses were performed to select the most informative features. Subsequently, a 5-fold cross-validation was used to compare the performance of different classification algorithms, and logistic regression was chosen to predict the risk of bone invasion.
RESULTS


Eight radiomic features were selected from T1C and T2 respectively, and three models were built using radiomic features. The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722 [95 % CI, 0.668-0.776] and in the test datasets of 0.715 [95 % CI, 0.632-0.798] and 0.713 [95 % CI, 0.628-0.798], respectively.
CONCLUSIONS


The radiomic model may aid clinicians with preoperative prediction of bone invasion by meningiomas, which can help in predicting prognosis and devising surgical strategies.",2020,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","['490 patients diagnosed with meningiomas, including WHO grade I (448cases), grade II (38cases), and grade III (4cases), were enrolled and 213 out of 490 cases (43.5 %) had bone invasion', 'bone invasion in meningiomas']","['magnetic resonance images', 'radiomic signatures based on preoperative, contrast-enhanced T1-weighted (T1C) and T2-weighted (T2) magnetic resonance imaging (MRI']",['risk of bone invasion'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025286', 'cui_str': 'Meningioma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",490.0,0.0309829,"The radiomic models derived from T1C alone or a combination of T1C and T2 had the best performance in predicting risk of bone invasion, with areas under the curve in the training dataset of 0.714 [95 % CI, 0.660-0.768] and 0.722","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China; Key Laboratory of Medical Imaging of Gansu Province, Lanzhou, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Philips Healthcare, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Yuntai', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical School, Lanzhou University, Lanzhou, China; Department of Radiology, Lanzhou University Second Hospital, Lanzhou, China. Electronic address: lzuzjl601@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109287']
2144,32980772,High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex relieves musculoskeletal pain in patients with Parkinson's disease: A randomized controlled trial.,"BACKGROUND


Pain is common in Parkinson's disease, and there is no effective treatment. We conducted a clinical trial to determine whether high-frequency repetitive transcranial magnetic stimulation over the primary motor cortex alleviates musculoskeletal pain in patients with Parkinson's disease.
METHODS


In this single-center and double-blind trial, 52 patients with Parkinson's disease and musculoskeletal pain were randomly allocated to 26-member groups receiving 5 sessions of either 20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex. The participants underwent assessments in the ""ON"" medication state at baseline, after the fifth session, and at 2- and 4-week follow-up timepoints. The primary outcomes were pain scores on a numeric rating scale. The secondary outcomes were scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease.
RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001). Post hoc analyses confirmed that the repetitive transcranial magnetic stimulation group, but not the sham stimulation group, exhibited significant improvements in numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores.
CONCLUSION


High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex may be an effective adjunct therapy for alleviating musculoskeletal pain in patients with Parkinson's disease.",2020,"RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[""patients with Parkinson's disease"", ""52 patients with Parkinson's disease and musculoskeletal pain""]","['repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation', '20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex', 'High-frequency repetitive transcranial magnetic stimulation']","[""scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease"", 'musculoskeletal pain', 'numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores', 'numeric rating scale pain scores', 'anxiety scores', 'pain scores on a numeric rating scale', 'depression scores', 'overall disease severity scores', 'motor symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",52.0,0.451476,"RESULTS


Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China.'}, {'ForeName': 'Tao-Mian', 'Initials': 'TM', 'LastName': 'Mi', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Ben-Fan', 'Initials': 'BF', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jing-Hong', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Wen-Ming', 'Initials': 'WM', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China. Electronic address: yangwm8810@126.com.'}, {'ForeName': 'Piu', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China; National Clinical Research Center for Geriatric Disorders, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: pbchan@hotmail.com.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.006']
2145,32990324,Anti-cytokine targeted therapies for ANCA-associated vasculitis.,"BACKGROUND


Anti-neutrophilic cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) are a group of rare auto-inflammatory diseases that affects mainly small vessels. AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Anti-cytokine targeted therapy uses biological agents capable of specifically targeting and neutralising cytokine mediators of the inflammatory response.
OBJECTIVES


To assess the benefits and harms of anti-cytokine targeted therapy for adults with AAV.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (2019, Issue 7), MEDLINE and Embase up to 16 August 2019. We also examined reference lists of articles, clinical trial registries, websites of regulatory agencies and contacted manufacturers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) or controlled clinical trials of targeted anti-cytokine therapy in adults (18 years or older) with AAV compared with placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane.
MAIN RESULTS


We included four RCTs with a total of 440 participants (mean age 48 to 56 years). We analysed the studies in three groups: 1) mepolizumab (300 mg; three separate injections every four weeks for 52 weeks) versus placebo in participants with relapsing or refractory EGPA; 2) belimumab (10 mg/kg on days 0, 14, 28 and every 28 days thereafter until 12 months after the last participant was randomised) or etanercept (25 mg twice a week) with standard therapy (median 25 months) versus placebo with standard therapy (median 19 months) in participants with GPA/MPA; and 3) infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42) versus rituximab (0.375g/m 2  on days 1, 8, 15 and 22) in participants with refractory GPA for up to 12 months. None of the studies were assessed as low risk of bias in all domains: one study did not report randomisation or blinding methods clearly. Three studies were at high risk and one study was at unclear risk of bias for selective outcome reporting. One trial with 136 participants with relapsing or refractory EGPA compared mepolizumab with placebo during 52 weeks of follow-up and observed one death in the mepolizumab group (1/68, 1.5%) and none in the placebo group (0/68, 0%) (Peto odds ratio (OR) 7.39, 95% confidence interval (CI) 0.15 to 372.38; low-certainty evidence). Low-certainty evidence suggests that more participants in the mepolizumab group had ≥ 24 weeks of accrued remission over 52 weeks compared to placebo (27.9% versus 2.9%; risk ratio (RR) 9.5, 95% CI 2.30 to 39.21), and durable remission within the first 24 weeks sustained until week 52 (19.1% mepolizumab versus 1.5% placebo; RR 13.0, 95% CI 1.75 to 96.63; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% Cl 4 to 13). Mepolizumab probably decreases risk of relapse (55.8% versus 82.4%; RR 0.68, 95% CI 0.53 to 0.86; NNTB 4, 95% CI 3 to 9; moderate-certainty evidence). There was low-certainty evidence regarding similar frequency of adverse events (AEs): total AEs (96.9% versus 94.1%; RR 1.03, 95% CI 0.96 to 1.11), serious AEs (17.7% versus 26.5%; RR 0.67, 95% CI 0.35 to 1.28) and withdrawals due to AEs (2.9% versus 1.5%; RR 2.00, 95% CI 0.19 to 21.54). Disease flares were not measured. Based on two trials with different follow-up periods (mean of 27 months for etanercept study; up to four years for belimumab study) including people with GPA (n = 263) and a small group of participants with MPA (n = 22) analysed together, we found low-certainty evidence suggesting that adding an active drug (etanercept or belimumab) to standard therapy does not increase or reduce mortality (3.4% versus 1.4%; Peto OR 2.45, 95% CI 0.55 to 10.97). Etanercept may have little or no effect on remission (92.3% versus 89.5%; RR 0.97, 95% CI 0.89 to 1.07), durable remission (70% versus 75.3%; RR 0.93, 95% CI 0.77 to 1.11; low-certainty evidence) and disease flares (56% versus 57.1%; RR 0.98, 95% CI 0.76 to 1.27; moderate-certainty evidence). Low-certainty evidence suggests that belimumab does not increase or reduce major relapse (1.9% versus 0%; RR 2.94, 95% CI 0.12 to 70.67) or any AE (92.5% versus 82.7%; RR 1.12, 95% CI 0.97 to 1.29). Low-certainty evidence suggests a similar frequency of serious or severe AEs (47.6% versus 47.6%; RR 1.00, 95% CI 0.80 to 1.27), but more frequent withdrawals due to AEs in the active drug group (11.2%) compared to the placebo group (4.2%), RR 2.66, 95% CI 1.07 to 6.59). One trial involving 17 participants with refractory GPA compared infliximab versus rituximab added to steroids and cytotoxic agents for 12 months. One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%). We have very low-certainty evidence for remission (22% versus 50%, RR 0.44, 95% Cl 0.11 to 1.81) and durable remission (11% versus 50%, RR 0.22, 95% CI 0.03 to 1.60), any severe AE (22.3% versus 12.5%; RR 1.78, 95% CI 0.2 to 16.1) and withdrawals due to AEs (0% versus 0%; RR 2.70, 95% CI 0.13 to 58.24). Disease flare/relapse and the frequency of any AE were not reported.
AUTHORS' CONCLUSIONS


We found four studies but concerns about risk of bias and small sample sizes preclude firm conclusions. We found moderate-certainty evidence that in patients with relapsing or refractory EGPA, mepolizumab compared to placebo probably decreases disease relapse and low-certainty evidence that mepolizumab may increase the probability of accruing at least 24 weeks of disease remission. There were similar frequencies of total and serious AEs in both groups, but the study was too small to reliably assess these outcomes. Mepolizumab may result in little to no difference in mortality. However, there were very few events. In participants with GPA (and a small subgroup of participants with MPA), etanercept or belimumab may increase the probability of withdrawal due to AEs and may have little to no impact on serious AEs. Etanercept may have little or no impact on durable remission and probably does not reduce disease flare.",2020,"One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%).","['AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA', 'adults with AAV', 'and Embase up to 16 August 2019', 'participants with relapsing or refractory EGPA; 2', 'We included four RCTs with a total of 440 participants (mean age 48 to 56 years', 'participants with GPA (and a small subgroup of participants with MPA', '136 participants with relapsing or refractory EGPA compared', 'people with GPA (n = 263) and a small group of participants with MPA (n = 22', '17 participants with refractory GPA compared', 'adults (18 years or older) with AAV compared with']","['placebo with standard therapy', 'etanercept', 'targeted anti-cytokine therapy', 'infliximab versus rituximab added to steroids and cytotoxic agents', 'Mepolizumab', 'mepolizumab', 'rituximab', 'infliximab', 'placebo', 'etanercept or belimumab', 'Etanercept', 'active drug (etanercept or belimumab', 'belimumab', 'placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose', 'mepolizumab with placebo']","['durable remission', 'adverse events (AEs): total AEs', 'frequencies of total and serious AEs', 'reduce mortality', 'disease relapse', 'disease flares', 'Disease flare/relapse and the frequency of any AE', 'risk of relapse', 'major relapse', 'Disease flares', 'remission', 'severe AE', 'mortality', 'serious AEs']","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0008728', 'cui_str': 'Eosinophilic granulomatosis with polyangiitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0199974', 'cui_str': 'Cytokine therapy'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0010868', 'cui_str': 'Cytotoxin'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",17.0,0.668187,"One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%).","[{'ForeName': 'Malgorzata M', 'Initials': 'MM', 'LastName': 'Bala', 'Affiliation': 'Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Malecka-Massalska', 'Affiliation': 'Rheumatology Department, Provincial Hospital, Radzyn Podlaski, Lublin, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Koperny', 'Affiliation': 'Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Joanna F', 'Initials': 'JF', 'LastName': 'Zajac', 'Affiliation': 'Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Jarczewski', 'Affiliation': 'Department of Pathophysiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': '2nd Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008333.pub2']
2146,32978546,Does motivational interviewing contribute to caries prevention in children from lower income families?,"Aim To investigate the differential preventive effect of motivational interviewing on early childhood caries according to socioeconomic variables in a primary healthcare setting. Trial design Randomised, double-blind trial with two parallel groups, based in a community setting.Study population Selected from an invited subgroup of children born in 2013 and 2014 in the northern area of the city of Porto Alegre, Rio Grande do Sul, BrazilInterventions Primary caregivers of the patients were randomised to receive information about breastfeeding, child nutrition and oral hygiene during an initial dental appointment in the patient's first year of life either by conventional delivery techniques or by motivational interviewing.Outcomes Analysis of dmfs index from clinical examinationResults Nine-hundred and fifteen patients were randomised to the two arms and 414 children were included in the study, with 501 lost to follow up. One-hundred and eighty-six received conventional health education, and 228 received motivational interviewing. The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group. The effect of motivational interviewing was statistically significant in the lower-income category with prevention of 57% of carious lesions. There was no such statistically significant difference in the higher income subjects.Conclusions The outcome showed reduced caries experience by children where their primary caregiver has received preventative advice via a motivational interviewing technique when compared to conventional education methods. This study suggests that motivational interviewing is more effective in more disadvantaged groups.",2020,"The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group.","['clinical examinationResults Nine-hundred and fifteen patients were randomised to the two arms and 414 children were included in the study, with 501 lost to follow up', 'early childhood caries according to socioeconomic variables in a primary healthcare setting', 'One-hundred and eighty-six received', 'children from lower income families', 'Study population Selected from an invited subgroup of children born in 2013 and 2014 in the northern area of the city of Porto Alegre']","['conventional health education, and 228 received motivational interviewing', 'conventional delivery techniques or by motivational interviewing', 'preventative advice via a motivational interviewing technique', 'motivational interviewing']",['caries rate'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}]",915.0,0.103488,"The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McCann', 'Affiliation': 'Post-CCST StR in Paediatric Dentistry, Department of Paediatric Dentistry, Glasgow Dental Hospital and School, 378 Sauchiehall Street, Glasgow, UK.'}]",Evidence-based dentistry,['10.1038/s41432-020-0127-1']
2147,32979027,Like clouds in a windy sky: Mindfulness training reduces negative affect reactivity in daily life in a randomized controlled trial.,"While prior research has found mindfulness to be linked with emotional responses to events, less is known about this effect in a non-clinical sample. Even less is known regarding the mechanisms of the underlying processes: It is unclear whether participants who exhibit increased acceptance show decreased emotional reactivity (i.e., lower affective responses towards events overall) or a speedier emotional recovery (i.e., subsequent decrease in negative affect) due to adopting an accepting stance. To address these questions, we re-analysed two Ambulatory Assessment data sets. The first (N Study1  = 125) was a 6-week randomized controlled trial (including a 40-day ambulatory assessment); the second (N Study2  = 175) was a 1-week ambulatory assessment study. We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training. Regarding the different facets of mindfulness, we found that the strongest predictor of both emotional reactivity and recovery was non-judgemental acceptance. Finally, we found that being aware of one's own thoughts and behaviour could be beneficial or detrimental for emotional recovery, depending on whether participants accepted their thoughts and emotions. Together, these findings provide evidence for predictions derived from the monitoring and acceptance theory.",2020,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.",[],['40-day ambulatory assessment'],['emotional reactivity'],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0324028,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Zarah', 'Initials': 'Z', 'LastName': 'Rowland', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kubiak', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2989']
2148,32979640,"Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease.","BACKGROUND


The negative impact of COPD on patients is not only physical, but also social and psychological.
OBJECTIVES


To examine the effects of decreased exercise capacity on health outcomes in patients with COPD.
METHODS


516 COPD patients divided into four groups according to the six-minute walking distances. Perception of dyspnea, quality of life, psychological symptoms were compared between groups.
RESULTS


All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001). Anxiety, depression and dyspnea scores were found to be lower (p<0.001) in all those walking over 350 m (p<0,001).
CONCLUSIONS


It has been observed that markers such as quality of life, anxiety and depression, which are known to be affected in COPD patients, progress better especially in patients walking over 350 m.",2020,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","['patients with chronic obstructive pulmonary disease', 'patients with COPD', '516 COPD patients divided into four groups according to the six-minute walking distances']",['exercise capacity'],"['Perception of dyspnea, quality of life, psychological symptoms', 'health outcomes', 'Anxiety, depression and dyspnea scores', 'disease-specific quality of life scores', 'perception of dyspnea, psychological symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",516.0,0.0268225,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","[{'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hulya', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey. Electronic address: drhdogan@yahoo.com.'}, {'ForeName': 'Naz', 'Initials': 'N', 'LastName': 'Ilknur', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Polat', 'Initials': 'P', 'LastName': 'Gulru', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.008']
2149,32979642,Incidence of immediate postextubation complications in critically Ill adult patients.,"BACKGROUND


Postextubation complication rates vary among studies. It is necessary to standardize a method to identify postextubation complications and determine their potential association with extubation failure and reintubation in critically ill adult patients.
OBJECTIVES


To describe immediate (up to 60 min) endotracheal postextubation complications in critically ill adult patients and determine whether these complications are associated with extubation failure.
METHODS


Secondary analysis of a Randomized Clinical Trial that included 240 critically ill adult patients, who were eligible for extubation. Overall complications include at least one major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics).
RESULTS


Incidence of overall, major and minor complications was 71.2%, 30.9% and 62.7%, respectively. Forty (16.9%) patients failed extubation, and thirty (12.7%) were reintubated. Of 168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated. Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
CONCLUSION


We have observed high incidence rates of overall, major and minor complications. The development of major complications was statistically significantly associated with extubation failure and reintubation. It is still unknown whether the identification and treatment of immediate postextubation complications have positive effects on patients' clinical course or whether the complications are a mere effect of the extubation procedure.",2020,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","['critically ill adult patients', '240 critically ill adult patients, who were eligible for extubation', '168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated', 'critically Ill adult patients']",[],"['major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics', 'Incidence of overall, major and minor complications', 'Overall complications']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4517569', 'cui_str': '137'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",240.0,0.149797,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","[{'ForeName': 'Mauro Federico', 'Initials': 'MF', 'LastName': 'Andreu', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina; Universidad Nacional de la Matanza, San Justo, Province of Buenos Aires, Argentina. Electronic address: mfandreu@gmail.com.'}, {'ForeName': 'Marco Guillermo', 'Initials': 'MG', 'LastName': 'Bezzi', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Dotta', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.016']
2150,32979646,Randomised controlled trial confirms benefit of enhanced recovery after surgery on length of stay in ovarian cancer: How low can we go?,,2020,,['ovarian cancer'],[],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]",[],[],,0.150722,,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bisch', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada. Electronic address: gsnelson@ucalgary.ca.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.015']
2151,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
2152,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
2153,32985775,Withdrawal of Medications Leads to Worsening of OGTT Parameters in Youth with Impaired Glucose Tolerance or Recently-Diagnosed Type 2 Diabetes.,"BACKGROUND


The RISE Pediatric Medication Study compared strategies for preserving β-cell function, including a 9-month follow-up after treatment withdrawal to test treatment effect durability.
OBJECTIVE


Evaluate OGTT measures of glucose and β-cell response through 12 months of intervention and 9 months of medication washout.
PARTICIPANTS


Youth (n=91) aged 10-19 years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D).
METHODS


A multi-center randomized clinical trial comparing insulin glargine for 3 months followed by metformin for 9 months (G→Met) or metformin alone (Met) for 12 months. We report within-group changes from baseline to end of medication intervention (M12), baseline to 9 months post-medication withdrawal (M21), and end of medication (M12) to M21. OGTT C-peptide index [CPI] paired with 1/fasting insulin evaluated β-cell response.
RESULTS


At M12, both treatments were associated with stable fasting glucose (G→Met baseline 6.0±0.1 vs. M12 5.9±0.2 mmol/L, p=0.62; Met baseline 6.1±0.2 vs. M12 6.0±0.2 mmol/L, p=0.73) and 2-hour glucose (G→Met baseline 10.2±0.4 vs. M12 9.3±0.5 mmol/L, p=0.03; Met baseline 10.2±0.4 vs. M12 10.6±0.6 mmol/L, p=0.88). Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
CONCLUSIONS


G→Met and Met were associated with stable glucose measures during 12 months of treatment in youth with IGT or recently diagnosed T2D. Glucose and β-cell response worsened post-medication withdrawal, suggesting treatment must be long-term or alternative treatments pursued. This article is protected by copyright. All rights reserved.",2020,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","['Youth (n=91) aged 10-19\u2009years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D', 'Youth with Impaired Glucose Tolerance or Recently-Diagnosed Type 2 Diabetes']","['insulin glargine', 'metformin']","['stable fasting glucose', 'fasting glucose', 'glucose and β-cell response', 'stable glucose measures', 'β-cell response']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",91.0,0.022497,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","[{'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""UPMC-Children's Hospital of Pittsburgh.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': 'University of Colorado Anschutz Medical Campus.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California Keck School of Medicine.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'University of Colorado Anschutz Medical Campus.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13129']
2154,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND


Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION


What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS


This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE


Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
2155,32987359,Cognitive impairment in Parkinson's disease: Associations between subjective and objective cognitive decline in a large longitudinal study.,"BACKGROUND


Cognitive decline creates substantial morbidity and cost in Parkinson's disease (PD) and clinicians have limited tools for counseling patients on prognosis. We aimed to use data from a randomized, controlled trial of isradipine in Parkinson's disease (STEADY-PD III) to determine which objective cognitive domain deficits drive patient complaints of cognitive symptoms.
METHODS


Neuro-Quality of Life (Neuro-QoL) Cognition: General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures), were administered at baseline, 1, 2, and 3 years in 324 people with PD. Baseline Montreal Cognitive Assessment (MoCA) was divided into 4 domains: visuospatial/executive, memory, attention, and language (objective measures). Spearman rank correlations and multiple regression models adjusted for other clinical variables evaluated associations between baseline Neuro-QoL domains and individual MoCA domains. Multiple regression models evaluated the association between baseline MoCA domain performance and Neuro-QoL change over three years. Cox proportional hazards predicted development of PD-MCI based on baseline and time-varying Neuro-QoL reporting.
RESULTS


Higher MoCA memory performance was associated with better Neuro-QoL-GC (β = 0.75, SE = 0.391, p = 0.05) and Neuro-QoL-EF (β = 0.81, SE = 0.36, p = 0.02) at baseline. There was a trend for baseline MoCA memory to predict the degree of subjective cognitive decline on the Neuro-QoL-EF (β = 0.70, SE = 0.42, p = 0.09). Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC. Increasing subjective cognitive complaints in Neuro-QoL-EF were associated with development of PD-MCI over 3 years of follow-up (HR = 0.95, CI = 0.90-1.0, p = 0.039).
CONCLUSIONS


Objective memory impairment may be a stronger predictor than executive or visuospatial dysfunction for the presence of subjective cognitive complaints in early PD.",2020,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"['324 people with PD', ""Parkinson's disease""]",['isradipine'],"['General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures', 'visuospatial/executive, memory, attention, and language (objective measures', 'Neuro-Quality of Life (Neuro-QoL) Cognition', 'subjective cognitive complaints', 'Cognitive impairment', 'Baseline Montreal Cognitive Assessment (MoCA', 'baseline MoCA domain performance and Neuro-QoL change']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",324.0,0.0435964,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mills', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kmills16@jhmi.edu.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'G Webster', 'Initials': 'GW', 'LastName': 'Ross', 'Affiliation': 'VA Pacific Islands Health Care System, Honolulu, HI, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida Morsani College of Medicine, Tampa, FL, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Lang', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Halverson', 'Affiliation': 'The University of Utah School of Medicine, East Salt Lake City, UT, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oakes', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Eberly', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Blindauer', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Aquino', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Simuni', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marras', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.028']
2156,32987360,Action observation improves sit-to-walk in patients with Parkinson's disease and freezing of gait. Biomechanical analysis of performance.,"INTRODUCTION


Freezing of gait (FoG) is one of the most disabling gait disorders in Parkinson's disease (PD), reflecting motor and cognitive impairments, mainly related to dopamine deficiency. Recent studies investigating kinematic and kinetic factors affecting gait in these patients showed a postural instability characterized by disturbed weight-shifting, inappropriate anticipatory postural adjustment, worse reactive postural control, and a difficulty executing complex motor tasks (i.e. sit-to-walk). These symptoms are difficult to alleviate and not very responsive to Levodopa. For this reason, additional therapeutic actions based on specific therapeutic protocols may help patients with their daily lives. We conducted a randomized control trial aimed to test if two clinical protocols for PD patients with FoG were effective to improve postural control.
METHODS


Rehabilitation protocols, conceived to improve gait, were based on learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues. We collected biomechanical data (Center of Mass COM, Center of Pressure COP, and moving timings), using the sit-to-walk task as a measure of motor and gait performance.
RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
CONCLUSION


We demonstrated for the first time that PD patients with FoG treated with an AOS protocol aimed at relearning appropriate gait patterns increased balance control and re-acquired more efficient postural control.",2020,"RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[""patients with Parkinson's disease and freezing of gait"", 'PD patients with FoG']","['learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues', 'Freezing of gait (FoG']","['total moving time and the area of the COP positions', 'balance control and re-acquired more efficient postural control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.0179806,"RESULTS


Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Mezzarobba', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy; Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Pellegrini', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Catalan', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Krüger', 'Affiliation': 'Gokhale Method Institute, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stragapede', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bernardis', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy. Electronic address: pbernardis@units.it.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.029']
2157,32979880,Hepatitis C and HIV combined screening in primary care: A cluster randomized trial.,"Hepatitis C virus (HCV) and HIV are major causes of worldwide disease. We aimed to evaluate the effect of a combined screening programme, which included a risk-assessment questionnaire and rapid tests for point-of-care diagnosis, on screening and new diagnosis rates. This prospective, cluster randomized study was carried out in primary care. The intervention arm included a 4-hour educational programme, the use of a risk-assessment questionnaire and rapid tests. In the control centres, only the educational intervention was provided. The main variables compared were the screening coverage and the number and rate of new HCV and HIV diagnoses. Of a total of 7991 participants, 4670 (58.5%) and 2894 (36.2%) presented a risk questionnaire for HIV or HCV, respectively. The younger participants, men and those from Latin America and Eastern Europe, showed the greatest risk of presenting with a positive questionnaire. The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; P < .001). Only two HIV-positives were identified compared to one in control centres. The rate of HCV diagnoses was higher among intervention centres, with 37 versus seven positive tests (OR 5.2; 95% CI 2.3-11.6; P < .001). Of them, 10 were new diagnoses and 27 had been previously diagnosed, although not linked to care. In conclusion, a simple operational programme can lead to an increase in HCV and HIV screening rates, compared to an exclusively educational programme. The selection of at-risk patients with a self-questionnaire and the use of rapid tests significantly increased the diagnostic rate of HCV infection.",2020,The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; p<0.001).,"['younger participants, men, and those from Latin America and Eastern Europe', 'primary care', 'Of a total of 7,991 participants, 4,670 (58.5%) and 2,894 (36.2%) presented a risk questionnaire for HIV or HCV, respectively']","['combined screening program', 'Hepatitis C and HIV combined screening', '4-hour educational program, the use of a risk-assessment questionnaire and rapid tests']","['HCV and HIV screening rates', 'overall screening coverage', 'diagnostic rate of HCV infection', 'rate of HCV diagnoses', 'screening coverage and the number and rate of new HCV and HIV diagnoses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0015177', 'cui_str': 'East European country'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",7991.0,0.0568424,The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; p<0.001).,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Sanz', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Vivancos', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Sánchez-Conde', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gómez-Ayerbe', 'Affiliation': 'Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Polo', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Labrador', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'Servicio Madrileño de Salud, SUMMA, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Mesa', 'Affiliation': 'Centro de Salud Avenida de Aragón, Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Muriel', 'Affiliation': 'Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Chamorro', 'Affiliation': 'Centro de Salud Aquitania, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'de la Fuente', 'Affiliation': 'Centro de Salud Aquitania, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez Elías', 'Affiliation': 'Centro de Salud García Noblejas, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Uranga', 'Affiliation': 'Centro de Salud García Noblejas, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Herrero', 'Affiliation': 'Centro de Salud Mar Báltico, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ares', 'Affiliation': 'Centro de Salud Mar Báltico, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Barea', 'Affiliation': 'Centro de Salud Canal de Panamá, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Pérez-Elías', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}]",Journal of viral hepatitis,['10.1111/jvh.13413']
2158,32979294,Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers.,"OBJECTIVE


Assess the feasibility of conducting a cluster randomized controlled trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers.
METHODS


Two-arm cluster RCT within Kaiser Permanente Northern California. We recruited patients with metastatic solid malignancies or hematological cancers and their informal caregivers. Intervention-group participants chose to use either a commercially available mindfulness app (10-20 min/day) or a webinar-based mindfulness course for 6 weeks. The waitlist control group received usual care. We assessed feasibility measures and obtained participant-reported data on quality of life (QoL; primary outcome) and distress outcomes (secondary) pre- and postintervention.
RESULTS


A hundred and three patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled. Nearly all participants chose the mindfulness app over the webinar-based program. Among the participants in the intervention arm who chose the mobile-app program and completed the postintervention (6-week) survey, 21 (68%) patients and 7 (47%) caregivers practiced mindfulness at least 50% of the days during the 6-week study period. Seventy-four percent of intervention participants were ""very"" or ""extremely"" satisfied with the mindfulness program. We observed improvements in anxiety, QoL, and mindfulness among patients in the intervention arm compared to those in the control group.
CONCLUSIONS


We demonstrated the feasibility of conducting a cluster RCT of mHealth MBI for advanced cancer patients and their caregivers. Such remote interventions can be helpful particularly during the COVID-19 pandemic.",2020,"We observed improvements in anxiety, quality of life, and mindfulness among patients in the intervention arm compared to those in the control group.
","['advanced cancer patients and their informal caregivers', 'Two-arm cluster RCT within Kaiser Permanente Northern California (KPNC', '103 patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled', 'patients with metastatic solid malignancies or hematological cancers and their informal caregivers', 'advanced cancer patients and their caregivers']","['mHealth mindfulness-based intervention', 'usual care', 'Intervention-group participants chose to use either a commercially available mindfulness app', 'technology-delivered mindfulness-based intervention (MBI) programs']","['anxiety, quality of life, and mindfulness', 'quality-of-life (primary outcome) and distress outcomes (secondary) pre- and post-intervention']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",103.0,0.0375436,"We observed improvements in anxiety, quality of life, and mindfulness among patients in the intervention arm compared to those in the control group.
","[{'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kurtovich', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'MegAnn', 'Initials': 'M', 'LastName': 'McGinnis', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aghaee', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Quesenberry', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Kolevska', 'Affiliation': 'Kaiser Permanente Napa/Solano Medical Center, Vallejo, California, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Greyz-Yusupov', 'Affiliation': 'Kaiser Permanente San Rafael Medical Center, San Rafael, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Avins', 'Affiliation': 'Kaiser Permanente Division of Research, Oakland, California, USA.'}]",Psycho-oncology,['10.1002/pon.5557']
2159,32985036,Impact of continuous passive motion on rehabilitation following total knee arthroplasty.,"BACKGROUND AND PURPOSE


There is an ongoing controversy in respect of the usage of continuous passive motion (CPM) following total knee arthroplasty (TKA). We analysed the impact of CPM on the early rehabilitation after TKA and the clinical outcome over the time.
METHODS


Forty patients were prospectively randomized to postoperative protocols following TKA. Half of them (n = 20) received the standard manual therapy alone and the others (n = 20) were treated additionally with CPM. Identical implants were used in all patients. Passive range of movement (PROM) was noted. Patient satisfaction and knee function was evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as well as the Knee Society Score (KSS) at time of discharge and 2 years postoperatively.
RESULTS


The patients in the solitary manual therapy group (MT) showed preoperatively a 7.2° greater PROM (p = .03) with 5.4° higher flexion (p = .05). Analogously, the KSS presented with 42.7 points a higher score result compared to the CPM group with 35.9 points (p = .03). Although the preoperative ability with 105.2° for flexion and 97.2° for the PROM were in favour of the group without CPM (99.8° resp. 90.0°), at time of discharge the patients with CPM reached with 111.0° a significant higher flexion and with 109.0° a higher PROM (MT group: 107.0° resp. 103.5°) (p = .04/.02). At 2 years follow-up both scores (WOMAC/KSS) and function (extension, flexion and PROM) were balanced (p > .05). Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
DISCUSSION


Although the addition of CPM did significantly improve knee flexion in the early postoperative stage, the difference might not represent a clinical relevance. Further, there were no notable effects on long-term clinical and functional results following TKA, so the routine application of CPM in the above stated setting might be ceased.",2020,"Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
","['total knee arthroplasty (TKA', 'Forty patients', 'total knee arthroplasty']","['continuous passive motion', 'standard manual therapy alone', 'CPM', 'continuous passive motion (CPM', 'TKA']","['knee flexion', 'Passive range of movement (PROM', 'Patient satisfaction and knee function', 'scores (WOMAC/KSS) and function (extension, flexion and PROM', 'PROM', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",40.0,0.0335773,"Patella resurfacing showed no impact on the clinical results at discharge or at time of last follow-up (p > .05).
","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Wirries', 'Affiliation': 'Department of Orthopedic Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ezechieli', 'Affiliation': 'Department of Orthopedic Surgery, St. Josefs Hospital, Salzkotten, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Stimpel', 'Affiliation': 'Therapiezentrum Langenhagen, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Skutek', 'Affiliation': 'Department of Orthopedic Surgery, Hannover Medical School, Hannover, Germany.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1869']
2160,32985149,"Four-Week, Home-Based, Robot Cognitive Intervention for Patients with Mild Cognitive Impairment: a Pilot Randomized Controlled Trial.","BACKGROUND AND PURPOSE


Previous studies suggest that cognitive intervention can mitigate the development of dementia in patients with mild cognitive impairment (MCI). However, the previous cognitive intervention was mostly provided as a group session, in which MCI patients sometimes had difficulty in regularly attending sessions or were reluctant to participate in group-based classes. Additionally, experienced instructors for traditional cognitive intervention may be unavailable in some chronic-care facilities or community centers. Considering these reasons, we have developed 5 programs for home-based cognitive intervention using a personal robot for MCI patients. In this preliminary study, we aimed to demonstrate the effects of our newly developed home-based cognitive intervention with robots on cognitive function in MCI patients.
METHODS


We conducted a single-blind randomized controlled trial enrolling 46 MCI patients. Participants were randomized into 2 groups: the robot cognitive intervention (robot) ( n =24) group and without cognitive intervention (control) ( n =22) group. The interventions comprised 60-min sessions per day for 4 weeks. The primary outcome was the change in cognitive function measured using the Cambridge Neuropsychological Test Automated Battery.
RESULTS


There were no significant baseline demographic or clinical differences between the robot and control groups. After the 4-week cognitive intervention, the robot group showed greater improvement in working memory than did the control group.
CONCLUSIONS


Our home-based cognitive intervention with a personal robot improved the working memory in MCI patients. Further studies with larger samples and longer study periods are required to demonstrate the effects of these programs in other cognitive domains in MCI patients.",2020,"After the 4-week cognitive intervention, the robot group showed greater improvement in working memory than did the control group.
","['patients with mild cognitive impairment (MCI', '46 MCI patients', 'Patients with Mild Cognitive Impairment', 'MCI patients']","['robot cognitive intervention (robot) ( n =24) group and without cognitive intervention (control', 'home-based cognitive intervention with robots', 'cognitive intervention', 'Robot Cognitive Intervention']","['Cambridge Neuropsychological Test Automated Battery', 'change in cognitive function', 'cognitive function', 'working memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",46.0,0.0426897,"After the 4-week cognitive intervention, the robot group showed greater improvement in working memory than did the control group.
","[{'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Bori R', 'Initials': 'BR', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyungho', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soo Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Chun', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kee Duk', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jee Hyang', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geon Ha', 'Initials': 'GH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea. geonha@ewha.ac.kr.'}]",Dementia and neurocognitive disorders,['10.12779/dnd.2020.19.3.96']
2161,32980608,Interprofessional simulation-based training in gynecologic oncology palliative care for students in the healthcare profession: A comparative randomized controlled trial.,"BACKGROUND


Preprofessional palliative care education may be inadequate, leaving a gap in health professional students' knowledge and understanding of managing patients with gynecologic cancer and their families. Interprofessional simulation-based training may be useful in helping health professional students gain the necessary skills required for palliative care.
OBJECTIVE


This study aimed to determine the effectiveness of different simulation methods used for interprofessional training on gynecologic oncology palliative care knowledge, interdisciplinary education perceptions, and teamwork attitudes of health professional students and to compare these methods.
DESIGN


A comparative randomized controlled trial was conducted with a pre-test and two post-tests.
SETTINGS


This study was conducted at a university in Ankara, Turkey, in 2016-2017.
PARTICIPANTS


A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study.
METHODS


Students were stratified by their profession and randomized by four blocks into high-fidelity simulation, hybrid simulation, and a control group. Data were collected using a semi-structured questionnaire form, palliative care knowledge test, interdisciplinary education perception scale, and teamwork attitudes questionnaire.
RESULTS


The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
CONCLUSION


The introduction of high-fidelity simulation and hybrid simulation or hybrid simulation-based interprofessional training in undergraduate education can increase students' palliative care knowledge, interdisciplinary education perception, and teamwork attitudes. Training programs that are used together with high-fidelity simulation and hybrid simulation applications in interdisciplinary training should be integrated into the undergraduate curricula of future cooperating health professions.",2020,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","['health professional students', 'A convenience sample of 84 interprofessional students (nursing, medical, nutrition-dietician, and social work) was used in the study', 'patients with gynecologic cancer and their families', 'Students were stratified by their profession', 'students in the healthcare profession', 'university in Ankara, Turkey, in 2016-2017']","['interprofessional training', 'Interprofessional simulation-based training', 'hybrid simulation-based interprofessional training']","['palliative care knowledge, interdisciplinary education perception, and teamwork attitudes']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",84.0,0.0506668,"The high-fidelity simulation and hybrid simulation groups improved their palliative care knowledge, interdisciplinary education perception, and teamwork attitudes from pre-test to first and second post-tests compared to the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uslu-Sahan', 'Affiliation': 'Department of Obstetrics and Gynecologic Nursing, Faculty of Nursing, Hacettepe University, Ankara, Turkey. Electronic address: fatma.uslu@hacettepe.edu.tr.'}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Terzioglu', 'Affiliation': 'Faculty of Health Science, Atilim University, Ankara, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104588']
2162,32980623,Successful implementation of text-based blood pressure monitoring for postpartum hypertension.,"OBJECTIVES


A clinical trial showed postpartum text-based blood pressure (BP) monitoring is effective in meeting clinical guidelines and reduces racial disparities in postpartum hypertension care. Our objective was to compare clinical outcomes to those from a clinical trial after implementation of the program in a second hospital within our hospital system.
STUDY DESIGN


Comparison of women randomized to text-based BP monitoring in a clinical trial compared to an implementation cohort clinically enrolled in text-based BP monitoring. BP outcomes and postpartum visit were compared in bivariate and multivariable analyses.
MAIN OUTCOME MEASURES


BP ascertainment was defined as at least 1 BP texted during the 10 days of monitoring. American College of Obstetricians and Gynecologists (ACOG) recommendation was defined as BP sent on postpartum day 3-4 and again day 7-10.
RESULTS


The implementation cohort had 333 women compared to 103 in the trial cohort. The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001). BP ascertainment (95.5% vs. 92.2%, adjusted OR 1.41, [95% CI 0.55, 3.58]) and proportion meeting ACOG recommendations (84.7% vs. 81.6%, adjusted OR 0.89 [95% CI 0.48, 1.64]) were similar between groups. There were no differences in BP ascertainment among Black and non-Black women in the trial or implementation cohort.
CONCLUSIONS


Text-based BP monitoring performed similarly in an implementation cohort compared to the trial participants. This program is scalable to manage postpartum hypertension and reduce racial disparities in postpartum care in women with hypertensive disorders of pregnancy.",2020,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","['postpartum hypertension', 'women with hypertensive disorders of pregnancy', '333 women compared to 103 in the trial cohort', 'American College of Obstetricians and Gynecologists (ACOG']","['text-based BP monitoring', 'text-based blood pressure monitoring', 'postpartum text-based blood pressure (BP) monitoring']","['BP ascertainment', 'proportion meeting ACOG recommendations', 'BP outcomes and postpartum visit']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0586884', 'cui_str': 'Obstetrician and gynecologist'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.173943,"The implementation cohort was older (p < 0.001), and more likely to be non-Black race (p < 0.001), married (<0.001), and have commercial insurance (<0.001).","[{'ForeName': 'Jourdan E', 'Initials': 'JE', 'LastName': 'Triebwasser', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA; Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: jourdan.triebwasser@pennmedicine.upenn.edu.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania Hospital University of Pennsylvania Perelman School of Medicine, 800 Spruce St. 2 Pine East, Philadelphia, PA 19107, USA. Electronic address: matthew.janssen@pennmedicine.upenn.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Hirshberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: adi.hirshberg@pennmedicine.upenn.edu.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Department of Obstetrics and Gynecology, Maternal and Child Health Research Center University of Pennsylvania Perelman School of Medicine, 421 Curie Boulevard, 1353 Biomedical Research Bldg. II/III, Philadelphia, PA 19104, USA. Electronic address: ssrinivas@pennmedicine.upenn.edu.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.09.001']
2163,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND


The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS


The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS


The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS


This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2020,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS


Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
2164,32981111,A randomized study comparing full dose and half dose of rituximab in relapsing pemphigus patients.,,2020,,['relapsing pemphigus patients'],['rituximab'],[],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0334927,,"[{'ForeName': 'Marwah Adly', 'Initials': 'MA', 'LastName': 'Saleh', 'Affiliation': 'Department of Dermatology, Cairo University School of Medicine, Kasralainy Hospital, Cairo, Egypt.'}, {'ForeName': 'Noha Adly', 'Initials': 'NA', 'LastName': 'Saleh', 'Affiliation': 'Department of Dermatology, Cairo University School of Medicine, Kasralainy Hospital, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.14349']
2165,32990252,Safety and Efficacy of Aspiration Thrombectomy or Pharmacomechanical Thrombectomy after Catheter-Directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Vein Thrombosis.,"Purpose


To evaluate the safety and efficacy of additional aspiration thrombectomy (AT) or pharmacomechanical thrombectomy (PMT) after catheter-directed thrombolysis (CDT) for the treatment of acute iliofemoral deep vein thrombosis (AIFDVT).
Materials and Methods


Between May 2017 and December 2018, 40 patients with AIFDVT were enrolled. Twenty underwent AT after CDT (CDTAT), while the remaining 20 underwent PMT using an AngioJet TM  device after CDT (CDTPMT). Thrombus clearance was assessed using computed tomography venography at 1 week after the procedure, as follows: grade I, ≤50%; grade II, 51% to 75%; grade III, >75%. Grade III was considered a successful outcome. Treatment outcomes (thrombus clearance, thrombolytic therapy duration, urokinase dose, major complications, residual filter thrombosis, and Villalta score) were compared between the groups.
Results


Successful thrombus clearance was achieved in 95% of the patients in both groups. Significant decreases in the thrombolytic therapy duration (P=0.018) and urokinase dose (P=0.014) were noted in the CDTPMT group. Major complications were not noted in both groups. Residual filter thrombi >10 mm were found in 6 filters in the CDTAT group and in 1 filter in the CDTPMT group (P=0.038). The Villalta scores at 6 months were 1.47±1.24 and 1.12±0.92 in the CDTAT and CDTPMT groups, respectively (P=0.372).
Conclusion


Both methods may be safe and effective management options for patients with AIFDVT. CDTPMT can reduce urokinase dosage, time and remained filter thrombus compared to CDTAT. Studies conducted in the future should compare the effects of overnight CDT followed by PMT with those of single-session PMT on patients with AIFDVT.",2020,Significant decreases in the thrombolytic therapy duration (P=0.018) and urokinase dose (P=0.014) were noted in the CDTPMT group.,"['Acute Iliofemoral Deep Vein Thrombosis', 'Materials and Methods\n\n\nBetween May 2017 and December 2018, 40 patients with AIFDVT were enrolled', 'acute iliofemoral deep vein thrombosis (AIFDVT', 'patients with AIFDVT']","['Aspiration Thrombectomy or Pharmacomechanical Thrombectomy after Catheter-Directed Thrombolysis', 'CDTPMT', 'additional aspiration thrombectomy (AT) or pharmacomechanical thrombectomy (PMT) after catheter-directed thrombolysis (CDT']","['Treatment outcomes (thrombus clearance, thrombolytic therapy duration, urokinase dose, major complications, residual filter thrombosis, and Villalta score', 'Thrombus clearance', 'Successful thrombus clearance', 'safety and efficacy', 'Villalta scores', 'Major complications', 'thrombolytic therapy duration']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340714', 'cui_str': 'Iliofemoral deep vein thrombosis'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4045995', 'cui_str': 'Aspiration Thrombectomy'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0448159,Significant decreases in the thrombolytic therapy duration (P=0.018) and urokinase dose (P=0.014) were noted in the CDTPMT group.,"[{'ForeName': 'Joong Kwon', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Wonkwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Kyung Yun', 'Initials': 'KY', 'LastName': 'Kim', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Wonkwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Byun', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Wonkwang University Hospital, Iksan, Korea.'}]",Vascular specialist international,['10.5758/vsi.200041']
2166,32982965,Establishment of Clinical Prediction Model Based on the Study of Risk Factors of Stroke in Patients With Type 2 Diabetes Mellitus.,"Purpose:  Stroke has sparked global concern as it seriously threatens people's life, bringing about dramatic health burdens on patients, especially for type 2 diabetes mellitus (T2DM) patients. Therefore, a risk scoring model is urgently valuable for T2DM patients to predict the risk of stroke incidence and for positive health intervention.  Methods:  We randomly divided 4,335 T2DM patients into two groups, training set ( n  = 3,252) and validation set ( n  = 1,083), at the ratio of 3:1. Characteristic variables were then selected based on the data of training set through least absolute shrinkage and selection operator regression. Three models were established to verify predictive ability. Foundation model was composed of basic information and physical indicators. Biochemical model consisted of biochemical indexes. Integrated model combined the above two models. Data of three models were then put into logistic regression analysis to form nomogram prediction models. Tools including  C  index, calibration plot, and curve analysis were implemented to test discrimination, calibration, and clinical use. To select the best predicting model, net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were put into effect.  Results:  Eleven risk factors were determined, including age, duration of T2DM, estimated glomerular filtration rate, systolic blood pressure, diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, triglyceride, body mass index, uric acid, and glycosylated hemoglobin A 1c , all with significant  P -values through logistic regression analysis. In the training set, areas under the curve of three models were 0.810, 0.819, and 0.884, whereas in the validation set, they were 0.836, 0.832, and 0.909. Through calibration plot, the S:P values in the training set were 0.836, 0.754, and 0.621 and were 0.918, 0.682, and 0.666 separately in the validation set. In terms of the decision curve analysis, the risk thresholds were, respectively, 8-73%, 8-98%, and 8%~ in the training set and 8-70%, 8-90%, and 8-95% in the validation set. With the aid of NRI and IDI, integrated model is proved to be the best model in training set and validation set. Besides, internal validation was conducted on all the subjects in this study, and the  C  index was 0.890 (0.873-0.907).  Conclusion:  This study established a model predicting risk of stroke for T2DM patients through a community-based survey.",2020,"Through calibration plot, the S:P values in the training set were 0.836, 0.754, and 0.621 and were 0.918, 0.682, and 0.666 separately in the validation set.","['Patients With Type 2 Diabetes Mellitus', 'T2DM patients through a community-based survey']",[],"['age, duration of T2DM, estimated glomerular filtration rate, systolic blood pressure, diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, triglyceride, body mass index, uric acid, and glycosylated hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",4335.0,0.0141867,"Through calibration plot, the S:P values in the training set were 0.836, 0.754, and 0.621 and were 0.918, 0.682, and 0.666 separately in the validation set.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'School of Public Health, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'School of Public Health, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00559']
2167,32979978,"Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND


Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.
METHODS


We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.
FINDINGS


Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.
INTERPRETATION


This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.
FUNDING


National Institute for Health Research.",2020,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"['women with chronic pelvic pain', '39 UK hospital centres', 'Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration', 'women with chronic pelvic pain and no obvious pelvic pathology', 'Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously', 'chronic pelvic pain in women (GaPP2', 'Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to']","['Gabapentin', 'gabapentin', 'placebo', 'gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo', 'gabapentin and 153 to placebo']","['mean worst NRS pain score', 'mean average NRS pain score', 'efficacy and safety', 'average numerical rating scale (NRS) pain scores', 'serious adverse event', 'average pain scores assessed separately on a numerical rating scale', 'Self-reported adverse events', 'Dizziness, drowsiness, and visual disturbances', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance'}]",39.0,0.778431,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: andrew.horne@ed.ac.uk.""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Vincent', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Koscielniak', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szubert', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Doust', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31693-7']
2168,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND


This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS


Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS


Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS


Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
2169,32980893,"Postoperative pain, pain management, and recovery at home after pediatric tonsil surgery.","PURPOSE


To explore the severity and duration of postoperative pain, the management of analgesics, and postoperative recovery in children undergoing tonsil surgery.
METHOD


Participants included 299 children aged 4-17 years undergoing tonsillotomy ± adenoidectomy (TT ± A) or tonsillectomy ± adenoidectomy (TE ± A). Data were collected up to 12 days. The child rated pain on the Face Pain Scale-Revised (FPS-R) and recovery using the Postoperative Recovery in Children (PRiC) questionnaire. Caregivers assessed their child's pain, anxiety, and nausea on a numeric analog scale and kept a log of analgesic administration.
RESULTS


High pain levels (FPS-R ≥ 4) were reported in all surgical and age groups (TT ± A age 4-11, TE ± A age 4-11, TE ± A age 12-17), but there were variations in pain intensity and duration within and between groups. The TE ± A group scored more days with moderate to very excruciating pain and lower recovery than the TT ± A group, with the worst outcomes reported by older TE ± A children. The majority of the children used paracetamol + COX-inhibitors at home, but regular administration of analgesics was lacking, particularly during late evening and at night. Few were received rescue medication (opioid or clonidine) despite severe pain. Physical symptoms and daily life activities were affected during the recovery period. There was moderate agreement between child and the caregiver's pain assessment scores.
CONCLUSION


Children reported a troublesome recovery with significant postoperative pain, particularly older children undergoing tonsillectomy. Pain treatment at home was suboptimal and lacked regular analgesic administration. Patient information needs to be improved regarding the importance of regular administration of analgesics and rescue medication.",2020,"The TE ± A group scored more days with moderate to very excruciating pain and lower recovery than the TT ± A group, with the worst outcomes reported by older TE ± A children.","['children undergoing tonsil surgery', 'Participants included 299 children aged 4-17\xa0years undergoing tonsillotomy\u2009±\u2009adenoidectomy (TT\u2009±\u2009A) or tonsillectomy\u2009±\u2009adenoidectomy (TE\u2009±\u2009A', 'older children undergoing tonsillectomy']",['rescue medication (opioid or clonidine'],"[""child's pain, anxiety, and nausea on a numeric analog scale and kept a log of analgesic administration"", 'Physical symptoms and daily life activities', 'High pain levels', 'Postoperative pain, pain management, and recovery at home', 'child rated pain on the Face Pain Scale-Revised (FPS-R) and recovery using the Postoperative Recovery in Children (PRiC) questionnaire']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0193930', 'cui_str': 'Incision of tonsil'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",299.0,0.0761958,"The TE ± A group scored more days with moderate to very excruciating pain and lower recovery than the TT ± A group, with the worst outcomes reported by older TE ± A children.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Alm', 'Affiliation': 'Department of Anaesthesia and Intensive Care, School of Health Sciences, Faculty of Medicine and Health, Örebro University, 701 82, Örebro, Sweden. fredrik.alm@oru.se.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lundeberg', 'Affiliation': ""Pain Treatment Service, Department of Physiology and Pharmacology, Karolinska Institute, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Ericsson', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06367-z']
2170,32989866,Pilot study on the influence of cold atmospheric plasma on bacterial contamination and healing tendency of chronic wounds.,"BACKGROUND


Cold atmospheric plasma (CAP) has been used successfully for wound treatment, with thrice weekly treatment intervals. In this study, we wished to investigate whether comparably beneficial results can be achieved even with once weekly CAP treatment.
PATIENTS AND METHODS


In this randomized clinical pilot study (RCT) patients with therapy-refractory chronic wounds were examined over a maximum of twelve weeks. Groups 1 and 2 were treated with CAP once and twice a week, respectively. Patients in Group 3 received placebo therapy once a week.
RESULTS


Wound area decreased significantly by 63.0 % in Group 1 (n = 14, P = 0.005) and by 46.8 % in Group 2 (n = 13, P = 0.007). In Group 3 (n = 10) the wounds grew on average 17.5 % larger. A significant reduction in pain was measured in both CAP-treated groups (Group 1: P = 0.042; Group 2: P = 0.027). Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005). After the 12-week CAP treatment, the reduction in bacterial load compared to the day of study inclusion averaged 50.4 % for Group 1 and 35.0 % for Group 2.
CONCLUSIONS


Our RCT shows that treatment with CAP improves various aspects of wound healing in patients with therapy-refractory chronic wounds. The results obtained for once weekly treatment with CAP were not inferior to those obtained when CAP treatment was three times a week. Treatment once a week is also easier and more economical to implement in clinical routine.",2020,Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005).,"['chronic wounds', 'RCT) patients with therapy-refractory chronic wounds', 'patients with therapy-refractory chronic wounds']","['placebo therapy', 'CAP', 'Cold atmospheric plasma (CAP', 'cold atmospheric plasma']","['wound-specific quality of life', 'reduction in bacterial load', 'wound healing', 'Wound area', 'pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0231065,Only in Group 2 was there a significant improvement in wound-specific quality of life (P = 0.005).,"[{'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Moelleken', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Jockenhöfer', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Wiegand', 'Affiliation': 'Department of Dermatology, Jena University Medical Center.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Buer', 'Affiliation': 'Department of Medical Microbiology, Essen University Medical Center.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Department of Medical Psychology and Behavioral Immunobiology, Essen University Medical Center.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dissemond', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Essen University Medical Center.'}]",Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG,['10.1111/ddg.14294']
2171,32987199,Pharmacodynamics of asfotase alfa in adults with pediatric-onset hypophosphatasia.,"BACKGROUND


Hypophosphatasia (HPP) is the rare, inherited, metabolic bone disease characterized by low activity of the tissue-nonspecific isoenzyme of alkaline phosphatase (TNSALP) leading to excess extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP). Asfotase alfa is the human recombinant enzyme-replacement therapy that replaces deficient TNSALP. However, there is limited information concerning the appropriate dose of asfotase alfa for adult patients with pediatric-onset HPP. Thus, we evaluated the pharmacodynamics and safety/tolerability of different doses of asfotase alfa in such patients.
METHODS


This 13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP. They were randomized 1:1:1 to receive a single subcutaneous dose of asfotase alfa (0.5, 2.0, or 3.0 mg/kg) at Week 1, then 3 times per week (ie, 1.5, 6.0, or 9.0 mg/kg/wk) starting at Week 3 for 7 weeks. Key outcome measures included change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure).
RESULTS


Twenty-seven adults received asfotase alfa 0.5 (n = 8), 2.0 (n = 10), and 3.0 (n = 9) mg/kg; all completed the study. Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59%). Median plasma PPi and PLP concentrations decreased from Baseline to Week 9 in all 3 cohorts. Differences in least squares mean (LSM) changes in PPi were significant with 2.0 mg/kg (p = 0.0008) and 3.0 mg/kg (p < 0.0001) vs. 0.5 mg/kg. Differences in LSM changes in PLP were also significant for 2.0 mg/kg (p = 0.0239) and 3.0 mg/kg (p = 0.0128) vs. 0.5 mg/kg. Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
CONCLUSIONS


Adults with pediatric-onset HPP receiving asfotase alfa at 6.0 mg/kg/wk (the recommended dose) or 9.0 mg/kg/wk had greater reductions in circulating PPi and PLP concentrations compared with a lower dose of 1.5 mg/kg/wk.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02797821.",2020,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","['Adults with pediatric-onset HPP receiving', 'Twenty-seven adults received asfotase alfa 0.5 (n=8), 2.0 (n=10), and 3.0 (n=9) mg/kg; all completed the study', 'adult patients with pediatric-onset HPP', 'Adults With Pediatric-Onset Hypophosphatasia', 'Median (range) age was 45 (18-77) years; most patients were white (96%) and female (59', '13-week, Phase 2a, open-label study enrolled adults (aged ≥18 years) with pediatric-onset HPP']","['single subcutaneous dose of asfotase alfa', 'asfotase alfa', 'Asfotase Alfa']","['Least squares mean (LSM) changes in PPi', 'LSM differences in PLP changes', 'change from Baseline to before the third dose during Week 9 (trough) in plasma PPi (primary outcome measure) and PLP (secondary outcome measure', 'circulating PPi and PLP concentrations', 'Median plasma PPi and PLP concentrations', 'pharmacodynamics and safety/tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0034266', 'cui_str': 'pyridoxal phosphate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.169277,"Injection site reactions were the most frequent treatment-emergent adverse event (78%), showing increasing frequency with increasing dose.
","[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Seefried', 'Affiliation': 'Orthopedic Department, University of Würzburg, Würzburg, Bavaria, Germany. Electronic address: l-seefried.klh@uni-wuerzburg.de.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Moseley', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Denker', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Watsky', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Center for Metabolic Bone Disease and Molecular Research, Shriners Hospitals for Children-St. Louis, St. Louis, MO, USA; Division of Bone and Mineral Diseases, Department of Internal Medicine, Washington University School of Medicine at Barnes-Jewish Hospital, St Louis, MO, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Dahir', 'Affiliation': 'Program for Metabolic Bone Disorders at Vanderbilt, Division of Diabetes and Endocrinology, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Bone,['10.1016/j.bone.2020.115664']
2172,32987210,"A commentary on ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection"" [Int. J. Surg. 81 (2020) 140-146].",,2020,,[],['Gentamicin-Saline Solution Versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.29653,,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Man', 'Affiliation': 'GKT School of Medical Education, Hodgkin Building, Newcomen Street, London, SE1 1UL, United Kingdom. Electronic address: julian.man@kcl.ac.uk.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Choy', 'Affiliation': 'University College London Hospital, 250 Euston Road, London, NW1 2PG, United Kingdom. Electronic address: b.choy@nhs.net.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.028']
2173,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND


Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS


To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS


A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS


Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION


FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
2174,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND


Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE


This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS


Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS


Higher f 0  mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0  was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0  and avoidance reduction.
DISCUSSION


This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
2175,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
2176,32988892,Minimal Access  vs.  Open Spine Surgery in Patients With Metastatic Spinal Cord Compression - A One-Center Randomized Controlled Trial.,"BACKGROUND/AIM


We conducted a randomized controlled trial to investigate whether minimally access spine surgery (MASS) is less morbid than open surgery (OS) in patients with metastatic spinal cord compression (MSCC).
PATIENTS AND METHODS


A total of 49 MSCC patients were included in the trial. The outcome measures were bleeding (L), operation time (min), re-operations and prolonged wound healing.
RESULTS


The median age was 67 years (range=42-85 years) and 40% were men. The peri-operative blood loss in the MASS-group was significantly lower than that in the OS-group; 0.175L vs. 0.500L, (p=0.002). The median operation time for MASS was 142 min (range=72-203 min) vs. 103 (range=59-435 min) for OS (p=0.001). There was no significant difference between the two groups concerning revision surgery or delayed wound healing.
CONCLUSION


The MASS technique in MSCC patients is associated with less blood loss, but a longer operation time when compared to the OS technique.",2020,The peri-operative blood loss in the MASS-group was significantly lower than that in the OS-group;,"['Patients With Metastatic Spinal Cord Compression ', 'patients with metastatic spinal cord compression (MSCC', '49 MSCC patients were included in the trial', 'The median age was 67 years (range=42-85 years) and 40% were men']","['open surgery (OS', 'Minimal Access  vs.  Open Spine Surgery', 'minimally access spine surgery (MASS']","['median operation time for MASS', 'revision surgery or delayed wound healing', 'bleeding (L), operation time (min), re-operations and prolonged wound healing', 'peri-operative blood loss', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4076184', 'cui_str': 'Metastatic spinal cord compression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0080178', 'cui_str': 'Spina bifida'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0151692', 'cui_str': 'Impaired wound healing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",49.0,0.154058,The peri-operative blood loss in the MASS-group was significantly lower than that in the OS-group;,"[{'ForeName': 'SØren Schmidt', 'Initials': 'SS', 'LastName': 'Morgen', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark s@smorgen.dk.'}, {'ForeName': 'Lars Valentin', 'Initials': 'LV', 'LastName': 'Hansen', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ture', 'Initials': 'T', 'LastName': 'Karbo', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Svardal-Stelmer', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gehrchen', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Dahl', 'Affiliation': 'Spine Unit, Department of Orthopedic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Anticancer research,['10.21873/anticanres.114581']
2177,32986087,Early Gluten Introduction and Celiac Disease in the EAT Study: A Prespecified Analysis of the EAT Randomized Clinical Trial.,"Importance


There are no strategies for the prevention of celiac disease (CD). Current guidelines stating that the age at gluten introduction does not affect the prevalence of CD are based on the results from several randomized clinical trials, but the doses of gluten and timing of its introduction varied.
Objective


To determine whether early introduction of high-dose gluten lowers the prevalence of CD at age 3 years.
Design, Setting, and Participants


The Enquiring About Tolerance (EAT) Study was an open-label randomized clinical trial. A total of 1303 children from the general population in England and Wales were recruited and followed up from November 2, 2009, to July 30, 2012. For the present study, samples were collected from November 1, 2012, to March 31, 2015, and data were analyzed from April 25, 2017, to September 17, 2018.
Interventions


Infants were randomized to consume 6 allergenic foods (peanut, sesame, hen's egg, cow's milk, cod fish, and wheat) in addition to breast milk from age 4 months (early introduction group [EIG]) or to avoid allergenic foods and follow UK infant feeding recommendations of exclusive breastfeeding until approximately age 6 months (standard introduction group [SIG]).
Main Outcomes and Measures


Evaluation of CD was an a priori secondary end point of the EAT Study, and at age 3 years, all children with available serum samples were tested for antitransglutaminase type 2 antibodies. Children with antibody levels greater than 20 IU/L were referred to independent gastroenterologists for further investigation.
Results


Of the 1004 infants included in the analysis, 514 were male (51.2%). The mean (SD) quantity of gluten consumed between ages 4 and 6 months was 0.49 (1.40) g/wk in the SIG and 2.66 (1.85) g/wk in the EIG (P < .001). Mean (SD) weekly gluten consumption ranged from 0.08 (1.00) g/wk at age 4 months to 0.9 (2.05) g/wk at age 6 months in the SIG vs 1.3 (1.54) g/wk at age 4 months to 4.03 (2.40) g/wk at age 6 months in the EIG. Seven of 516 children from the SIG (1.4%) had a diagnosis of CD confirmed vs none of the 488 children in the EIG (P = .02, risk difference between the groups using the bootstrap, 1.4%; 95% CI, 0.6%-2.6%).
Conclusions and Relevance


In this analysis of infants in the EAT Study, the introduction of gluten from age 4 months was associated with reduced CD prevalence. These results suggest that early high-dose consumption of gluten should be considered as a strategy to prevent CD in future studies.
Trial Registration


isrctn.org Identifier: ISRCTN14254740.",2020,g/wk in the EIG (P < .001).,"['samples were collected from November 1, 2012, to March 31, 2015, and data were analyzed from April 25, 2017, to September 17, 2018', 'Children with antibody levels greater than 20 IU/L were referred to independent gastroenterologists for further investigation', '1303 children from the general population in England and Wales were recruited and followed up from November 2, 2009, to July 30, 2012', '1004 infants included in the analysis, 514 were male (51.2', 'Early Gluten Introduction and Celiac Disease in the EAT Study']","[""consume 6 allergenic foods (peanut, sesame, hen's egg, cow's milk, cod fish, and wheat) in addition to breast milk from age 4 months (early introduction group [EIG]) or to avoid allergenic foods and follow UK infant feeding recommendations of exclusive breastfeeding until approximately age 6 months (standard introduction group [SIG""]","['diagnosis of CD', 'Mean (SD) weekly gluten consumption', 'Enquiring About Tolerance (EAT', 'mean (SD) quantity of gluten consumed']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0446376', 'cui_str': 'Cod'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",1303.0,0.147453,g/wk in the EIG (P < .001).,"[{'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""The Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""The Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""The Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""The Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""The Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""The St John's Institute of Dermatology, Guy's and St Thomas' Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Benaroya Research Institute, Seattle, Washington.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""The Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2893']
2178,32986097,Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial.,"Importance


The efficacy and safety of time-restricted eating have not been explored in large randomized clinical trials.
Objective


To determine the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.
Interventions


Participants were randomized such that the consistent meal timing (CMT) group was instructed to eat 3 structured meals per day, and the time-restricted eating (TRE) group was instructed to eat ad libitum from 12:00 pm until 8:00 pm and completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day.
Design, Setting, and Participants


This 12-week randomized clinical trial including men and women aged 18 to 64 years with a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 to 43 was conducted on a custom mobile study application. Participants received a Bluetooth scale. Participants lived anywhere in the United States, with a subset of 50 participants living near San Francisco, California, who underwent in-person testing.
Main Outcomes and Measures


The primary outcome was weight loss. Secondary outcomes from the in-person cohort included changes in weight, fat mass, lean mass, fasting insulin, fasting glucose, hemoglobin A1c levels, estimated energy intake, total energy expenditure, and resting energy expenditure.
Results


Overall, 116 participants (mean [SD] age, 46.5 [10.5] years; 70 [60.3%] men) were included in the study. There was a significant decrease in weight in the TRE (-0.94 kg; 95% CI, -1.68 to -0.20; P = .01), but no significant change in the CMT group (-0.68 kg; 95% CI, -1.41 to 0.05, P = .07) or between groups (-0.26 kg; 95% CI, -1.30 to 0.78; P = .63). In the in-person cohort (n = 25 TRE, n = 25 CMT), there was a significant within-group decrease in weight in the TRE group (-1.70 kg; 95% CI, -2.56 to -0.83; P < .001). There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m2; 95% CI, -0.27 to -0.05; P = .005). There were no significant changes in any of the other secondary outcomes within or between groups. There were no differences in estimated energy intake between groups.
Conclusions and Relevance


Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03393195 and NCT03637855.",2020,"There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m2; 95% CI, -0.27 to -0.05; P = .005).","['116 participants (mean [SD] age, 46.5 [10.5] years; 70 [60.3%] men) were included in the study', 'men and women aged 18 to 64 years with a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 to 43 was conducted on a custom mobile study application', 'Women and Men With Overweight and Obesity', 'Participants lived anywhere in the United States, with a subset of 50 participants living near San Francisco, California, who underwent in-person testing']","['16:8-hour time-restricted eating', 'Time-Restricted Eating', 'consistent meal timing (CMT) group was instructed to eat 3 structured meals per day, and the time-restricted eating (TRE) group was instructed to eat ad libitum from 12:00 pm until 8:00 pm and completely abstain from caloric intake', 'Bluetooth scale']","['weight loss', 'weight', 'appendicular lean mass index', 'weight in the TRE', 'changes in weight, fat mass, lean mass, fasting insulin, fasting glucose, hemoglobin A1c levels, estimated energy intake, total energy expenditure, and resting energy expenditure', 'estimated energy intake', 'Weight Loss', 'weight loss and metabolic risk markers']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",116.0,0.2497,"There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m2; 95% CI, -0.27 to -0.05; P = .005).","[{'ForeName': 'Dylan A', 'Initials': 'DA', 'LastName': 'Lowe', 'Affiliation': 'Cardiovascular Research Institute, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Cardiology Division, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Rohdin-Bibby', 'Affiliation': 'Cardiology Division, University of California, San Francisco, San Francisco.'}, {'ForeName': 'A Holliston', 'Initials': 'AH', 'LastName': 'Moore', 'Affiliation': 'Cardiology Division, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Kelly', 'Affiliation': ""University of Hawai'i Cancer Center, Honolulu.""}, {'ForeName': 'Yong En', 'Initials': 'YE', 'LastName': 'Liu', 'Affiliation': ""University of Hawai'i Cancer Center, Honolulu.""}, {'ForeName': 'Errol', 'Initials': 'E', 'LastName': 'Philip', 'Affiliation': 'University of California School of Medicine, San Francisco.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Cardiology Division, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'Cardiology Division, University of California, San Francisco, San Francisco.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Shepherd', 'Affiliation': ""University of Hawai'i Cancer Center, Honolulu.""}, {'ForeName': 'Ethan J', 'Initials': 'EJ', 'LastName': 'Weiss', 'Affiliation': 'Cardiovascular Research Institute, University of California, San Francisco, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.4153']
2179,32981299,"A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol.","BACKGROUND


Radioactive iodine (RAI) remnant ablation is recommended in patients with papillary thyroid cancer (PTC) and extrathyroidal extension or central lymph node metastasis. However, there exists little evidence about the necessity of remnant ablation in PTC patients with low- to intermediate-risk, those have been increasing in recent decades.
METHODS


This multicenter, prospective, non-randomized, parallel group clinical trial will enroll 310 eligible patients with low- to intermediate-risk of thyroid cancer. Inclusion criteria are patients who recently underwent total thyroidectomy for PTC with 3 or less tumors of size 1≤ to ≤2 cm with no microscopic extension and N0/x, or size ≤2 cm with microscopic extension and/or N1a (number of lymph node ≤3, size of tumor foci ≤0.2 cm, and lymph node ratio &lt;0.4). Patients choose to undergo RAI ablation (131I, dose 1.1 GBq) or diagnostic whole-body scan (DxWBS) (131I or 123I, dose 0.074 to 0.222 GBq), followed by subsequent measurement of stimulated thyroglobulin (sTg) within 1 year. Survey for quality of life (QOL) will be performed at baseline and at 1 year after follow-up. The total enrollment period is 5 years, and patients will be followed up for 1 year. The primary endpoint is the non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ≤2 ng/mL) without evidence of structural recurrence. The secondary endpoint was the difference of QOL.
CONCLUSION


This study will evaluate whether surgery alone achieves similar BCR and improved QOL compared to RAI ablation in patients with low- to intermediate-risk PTC within 1 year.",2020,The primary endpoint is the non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ≤2 ng/mL) without evidence of structural recurrence.,"['310 eligible patients with low- to intermediate-risk of thyroid cancer', 'Inclusion criteria are patients who recently underwent total thyroidectomy for PTC with 3 or less tumors of size 1≤ to ≤2 cm with no microscopic extension and N0/x, or size ≤2 cm with microscopic extension and/or N1a ', 'Low- to Intermediate-Risk of Papillary Thyroid Cancer', 'patients with papillary thyroid cancer (PTC) and extrathyroidal extension or central lymph node metastasis', 'patients with low- to intermediate-risk PTC within 1 year']","['Radioactive iodine (RAI) remnant ablation', 'Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment', 'RAI ablation']","['quality of life (QOL', 'QOL', 'non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ≤2 ng/mL) without evidence of structural recurrence', 'BCR and improved QOL']","[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0456906', 'cui_str': 'Node stage N1a'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0105421', 'cui_str': 'BCR protein, human'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",310.0,0.101427,The primary endpoint is the non-inferiority of surgery alone to surgery with ablation in terms of biochemical remission (BCR) rate (sTg ≤2 ng/mL) without evidence of structural recurrence.,"[{'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Center for Thyroid Cancer, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'You Jin', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Center for Thyroid Cancer, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Young Joo', 'Initials': 'YJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ka Hee', 'Initials': 'KH', 'LastName': 'Yi', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Koon Soon', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Joo Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Sun Wook', 'Initials': 'SW', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jungnam', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Yul', 'Initials': 'Y', 'LastName': 'Hwangbo', 'Affiliation': 'Center for Thyroid Cancer, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Sujeong', 'Initials': 'S', 'LastName': 'Go', 'Affiliation': 'Center for Thyroid Cancer, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Do Joon', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}]","Endocrinology and metabolism (Seoul, Korea)",['10.3803/EnM.2020.681']
2180,32990231,[Effect of Straumann implant on crown appearance in immediate implant restoration of maxillary anterior teeth].,"OBJECTIVE


To investigate the effect of Straumann implant on crown appearance in the immediate implant restoration of maxillary anterior teeth.
METHODS


This study was conducted among 86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018. We randomized the patients into control group for treatment with immediate implant restoration and study group receiving additional Straumann implant. The effects of restoration, bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were compared between the two groups.
RESULTS


The repair effect in the study group was better than that in the control group ( P  < 0.05). The implant length and implant diameter were significantly greater in the study group than in the control group. The root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were all better in the study group. The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
CONCLUSIONS


Straumann implant can be used in immediate implant restoration of maxillary anterior teeth to achieve a better aesthetic effect.",2020,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","['86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018', 'maxillary anterior teeth']","['immediate implant restoration and study group receiving additional Straumann implant', 'Straumann implant']","['bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'implant length and implant diameter', 'root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'repair effect', 'height of marginal bone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",86.0,0.0218608,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","[{'ForeName': 'Zhongxiong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Stomatological Hospital of Southern Medical University, Guangzhou 510220, China.'}, {'ForeName': 'Shaoqun', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.22']
2181,32990234,[Construction and validation of a nomogram for predicting the risk of portal vein thrombosis after splenectomy in patients with hepatitis B cirrhosis].,"OBJECTIVE


To construct and validate an individualized nomogram to predict the probability of occurrence of portal vein thrombosis (PVT) after splenectomy in patients with hepatitis B cirrhosis.
METHODS


We retrospectively collected the clinical data from 180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital. The patients were randomized into modeling group ( n = 120) and validation group ( n =60), and the former group was further divided into PVT group ( n =49) and non-PVT group ( n =71) according to the occurrence of PVT occurred within 1 month after splenectomy. The independent risk factors of PVT after splenectomy were screened in the modeling group using univariate and multivariate binary logistic regression analyses and were used for construction of the nomogram prediction model. The area under the receiver-operating characteristic (AUROC) curve (C-index), GiViTI calibration belt and Hosmer-Lemeshow test, and the DCA curve were used to estimate the discrimination power, calibration and clinical efficiency of the prediction model in both the model construction group and validation group.
RESULTS


Univariate and multivariate logistic regression analyses showed that a history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer differed significantly between PVT group and non-PVT group ( P  < 0.05), and portal vein diameter, spleen vein diameter, and postoperative platelet change were independent risk factors of PVT after splenectomy ( P  < 0.05). The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group. The 80% and 95% CI  region of GiViTI calibration belt did not cover the 45-degree diagonal bisector line ( P =0.965 and 0.632, respectively), and the P-values of the Hosmer-Lemeshow test were 0.624 and 0.911, respectively, suggesting a high reliability of the predicted probability by the model. DCA curve analysis showed a threshold probability of 30.5%, with a net benefit of 30% in the modeling group and 34% in the validation group, indicating a good clinical efficiency of the model.
CONCLUSIONS


The model for predicting the risk of PVT after splenectomy in patients with hepatitis B cirrhosis can help in early identification of patients having high risks of PVT.",2020,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"['180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital', 'patients with hepatitis B cirrhosis']",[],"['history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer', 'portal vein diameter, spleen vein diameter, and postoperative platelet change', 'portal vein thrombosis', 'portal vein thrombosis (PVT']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439652', 'cui_str': 'Varicose'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235603', 'cui_str': 'Platelet changes'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}]",180.0,0.0292147,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Tu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.07']
2182,32986498,Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study.,"PURPOSE


In previous analyses of the MURANO study, fixed-duration venetoclax plus rituximab (VenR) resulted in improved progression-free survival (PFS) compared with bendamustine plus rituximab (BR) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). At the 4-year follow-up, we report long-term outcomes, response to subsequent therapies, and the predictive value of molecular and genetic characteristics.
PATIENTS AND METHODS


Patients with CLL were randomly assigned to 2 years of venetoclax (VenR for the first six cycles) or six cycles of BR. PFS, overall survival (OS), peripheral-blood minimal residual disease (MRD) status, genomic complexity (GC), and gene mutations were assessed.
RESULTS


Of 389 patients, 194 were assigned to VenR and 195 to BR. Four-year PFS and OS rates were higher with VenR than BR, at 57.3% and 4.6% (hazard ratio [HR], 0.19; 95% CI, 0.14 to 0.25), and 85.3% and 66.8% (HR, 0.41; 95% CI, 0.26 to 0.65), respectively. Undetectable MRD (uMRD) at end of combination therapy (EOCT) was associated with superior PFS compared with low MRD positivity (HR, 0.50) and high MRD positivity (HR, 0.15). Patients in the VenR arm who received ibrutinib as their first therapy after progression (n = 12) had a reported response rate of 100% (10 of 10 evaluable patients); patients subsequently treated with a venetoclax-based regimen (n = 14) had a reported response rate of 55% (six of 11 evaluable patients). With VenR, the uMRD rate at end of treatment (EOT) was lower in patients with GC than in those without GC ( P  = .042); higher GC was associated with shorter PFS. Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
CONCLUSION


Efficacy benefits with fixed-duration VenR are sustained and particularly durable in patients who achieve uMRD. Salvage therapy with ibrutinib after VenR achieved high response rates. Genetic mutations and GC affected MRD rates and PFS.",2020,"Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
","['Relapsed Chronic Lymphocytic Leukemia', 'patients with relapsed or refractory chronic lymphocytic leukemia (CLL', '389 patients', 'patients who achieve uMRD', 'Patients with CLL']","['venetoclax (VenR', 'Venetoclax Plus Rituximab', 'bendamustine plus rituximab (BR']","['PFS, overall survival (OS), peripheral-blood minimal residual disease (MRD) status, genomic complexity (GC), and gene mutations', 'Higher MRD positivity rates', 'Undetectable MRD (uMRD', 'response rate', 'MRD rates and PFS', 'uMRD rate', 'OS rates', 'progression-free survival (PFS']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",389.0,0.127946,"Higher MRD positivity rates were seen with  BIRC3  and  BRAF  mutations at EOCT and with  TP53 ,  NOTCH1 ,  XPO1 , and  BRAF  mutations at EOT.
","[{'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Jenny Qun', 'Initials': 'JQ', 'LastName': 'Wu', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kipps', 'Affiliation': 'University of California School of Medicine, San Diego, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""D'Rozario"", 'Affiliation': 'The John Curtin School of Medical Research, Australian National University, Canberra, Australia.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Assouline', 'Affiliation': 'Segal Cancer Center, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': 'Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'Department of Clinical Hematology, University Hospital Montpellier, Montpellier, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eldering', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Mellink', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Van Der Kevie-Kersemaekers', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands.'}, {'ForeName': 'Su Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chyla', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Punnoose', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Zoe June', 'Initials': 'ZJ', 'LastName': 'Assaf', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lefebure', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00948']
2183,32986075,Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial.,"Importance


Effective and practical treatments are needed to increase physical activity among those at heightened risk from inactivity. Walking represents a popular physical activity that can produce a range of desirable health effects, particularly as people age.
Objective


To test the hypothesis that counseling by a computer-based virtual advisor is no worse than (ie, noninferior to) counseling by trained human advisors for increasing 12-month walking levels among inactive adults.
Design, Setting, and Participants


A cluster-randomized, noninferiority parallel trial enrolled 245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017. Data analysis was performed from March 15 to December 20, 2018. The evidence-derived noninferiority margin was 30 minutes of walking per week. Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California.
Interventions


All participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a computerized virtual advisor program (virtual) or a previously validated peer advisor program (human).
Main Outcomes and Measures


The primary outcome was change in walking minutes per week over 12 months using validated interview assessment corroborated with accelerometry. Both per-protocol and intention-to-treat analysis was performed.
Results


Among the 245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino. Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level, mean BMI was 32.8 (6.8), and mean years residence in the US was 47.4 (17.0) years. A total of 231 participants (94.3%) completed the study. Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n = 122) (difference, 22.0, with lower limit of 1-sided 95% CI, -20.6 to infinity; P = .02); this finding supports noninferiority. Improvements emerged in both arms for relevant clinical risk factors, sedentary behavior, and well-being measures.
Conclusions and Relevance


The findings of this study indicate that a virtual advisor using evidence-based strategies produces significant 12-month walking increases for older, lower-income Latino adults that are no worse than the significant improvements achieved by human advisors. Changes produced by both programs are commensurate with those reported in previous investigations of these behavioral interventions and provide support for broadening the range of light-touch physical activity programs that can be offered to a diverse population.
Trial Registration


ClinicalTrials.gov Identifier: NCT02111213.",2020,"Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n ","['\u2009122', 'Underserved Populations', '245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino', 'A total of 231 participants (94.3%) completed the study', 'Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California.\nInterventions\n\n\nAll participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a', 'Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level', '245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017']","['computerized virtual advisor program (virtual) or a previously validated peer advisor program (human', 'Counseling by Peer Human Advisors vs Computers to Increase Walking']","['relevant clinical risk factors, sedentary behavior, and well-being measures', 'mean BMI', 'change in walking minutes', 'physical activity']","[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",245.0,0.137457,"Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n ","[{'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Maria Ines', 'Initials': 'MI', 'LastName': 'Campero', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jylana L', 'Initials': 'JL', 'LastName': 'Sheats', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Castro Sweet', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Chazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Blanco', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Banda', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahn', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernandez', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, Massachusetts.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Bickmore', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, Massachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.4143']
2184,32989082,Delivery and Impact of a Motivational Intervention for Smoking Cessation: A PROS Study.,"OBJECTIVES


We tested a Public Health Service 5As-based clinician-delivered smoking cessation counseling intervention with adolescent smokers in pediatric primary care practice.
METHODS


We enrolled clinicians from 120 practices and recruited youth (age ≥14) from the American Academy of Pediatrics Pediatric Research in Office Settings practice-based research network. Practices were randomly assigned to training in smoking cessation (intervention) or social media counseling (attentional control). Youth recruited during clinical visits completed confidential screening forms. All self-reported smokers and a random sample of nonsmokers were offered enrollment and interviewed by phone at 4 to 6 weeks, 6 months, and 12 months after visits. Measures included adolescents' report of clinicians' delivery of screening and counseling, current tobacco use, and cessation behaviors and intentions. Analysis assessed receipt of screening and counseling, predictors of receiving 5As counseling, and effects of interventions on smoking behaviors and cessation at 6 and 12 months.
RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001). In both arms, clinicians more often screened smokers than nonsmokers. At 6 months, study arm was not significantly associated with successful cessation; however, smokers in the 5As group were more likely to have quit at 12 months. Addicted smokers more often were counseled, regardless of study arm, but were less likely to successfully quit smoking.
CONCLUSIONS


Adolescent smokers whose clinicians were trained in 5As were more likely to receive smoking screening and counseling than controls, but the ability of this intervention to help adolescents quit smoking was limited.",2020,"RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001).","['120 practices and recruited youth (age ≥14) from the American Academy of Pediatrics Pediatric Research in Office Settings practice-based research network', 'Adolescent smokers', 'adolescent smokers in pediatric primary care practice', 'Smoking Cessation', 'Youth recruited during clinical visits completed confidential screening forms']","['Motivational Intervention', 'smoking screening and counseling', 'Public Health Service 5As-based clinician-delivered smoking cessation counseling intervention', 'training in smoking cessation (intervention) or social media counseling (attentional control']","['successful cessation', ""adolescents' report of clinicians' delivery of screening and counseling, current tobacco use, and cessation behaviors and intentions""]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0315772,"RESULTS


Clinicians trained in the 5As intervention delivered more screening (β = 1.0605,  P  < .0001) and counseling (β = 0.4354,  P  < .0001).","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Klein', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, Illinois; jonklein@uic.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gorzkowski', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Elissa A', 'Initials': 'EA', 'LastName': 'Resnick', 'Affiliation': 'Department of Pediatrics, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kaseeska', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Pbert', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Prokorov', 'Affiliation': 'MD Anderson Center, Houston, Texas.'}, {'ForeName': 'Tianxiu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gotlieb', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wasserman', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois.'}]",Pediatrics,['10.1542/peds.2020-0644']
2185,32989073,"Patient, Clinician, and Communication Factors Associated with Colorectal Cancer Screening.","INTRODUCTION


Screening for colorectal cancer is beneficial. Yet, screening remains suboptimal, and underserved populations are at greater risk for not being appropriately screened. Although many barriers to screening are understood, less is known about how the decision-making process on whether to receive colonoscopy or stool testing influences screening.
METHODS


As part of a randomized controlled trial to test engaging underserved populations in preventive care through online, personalized, educational material, 2417 patients aged 50 to 74 years were randomly selected from the 70,998 patients with an office visit the year prior and mailed a survey to assess decision-making for colorectal cancer screening. Twenty practices in practice-based research networks from 5 diverse states participated. Survey data were supplemented with electronic health record data.
RESULTS


Among respondents, 64% were or became up to date with screening within 3 months of their office visit. The main factor associated with being up to date was the length of the patient-clinician relationship (<6 months vs 5+ years: odds ratio [OR], 0.49; 95% CI, 0.30-0.80). Sharing the decision about screening options with the clinician was a predictor for being up to date compared with patients who made the decision for themselves (OR, 1.75; 95% CI, 1.27-2.44). Only 36% of patients reported being given a choice about screening options. Traditional factors like race, employment, insurance, and education were not associated with screening.
CONCLUSIONS


Having a long-term relationship with a primary care clinician and sharing decisions may be key drivers to ensure evidence-based preventive care for underserved populations.",2020,"As part of a randomized controlled trial to test engaging underserved populations in preventive care through online, personalized, educational material, 2417 patients aged 50 to 74 years were randomly selected from the 70,998 patients with an office visit the year prior and mailed a survey to assess decision-making for colorectal cancer screening.","['2417 patients aged 50 to 74 years were randomly selected from the 70,998 patients with an', 'Twenty practices in practice-based research networks from 5 diverse states participated']",['office visit the year prior and mailed a survey to assess decision-making for colorectal cancer screening'],"['Patient, Clinician, and Communication Factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",2417.0,0.0690225,"As part of a randomized controlled trial to test engaging underserved populations in preventive care through online, personalized, educational material, 2417 patients aged 50 to 74 years were randomly selected from the 70,998 patients with an office visit the year prior and mailed a survey to assess decision-making for colorectal cancer screening.","[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV). alexander.krist@vcuhealth.org.'}, {'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Hochheimer', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Puro', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Peele', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Lail-Kashiri', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'From the Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond (AHK, CJH, RTS, PL-K), Department of Biostatistics, Virginia Commonwealth University, Richmond (CJH, RTS); OCHIN, Portland, OR (JP), RTI International, Research Triangle Park, NC (EP), Department of Health Promotion and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Houston (SWV).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.05.190378']
2186,32989176,β-lactolin increases cerebral blood flow in dorsolateral prefrontal cortex in healthy adults: a randomized controlled trial.,"The number of elderly individuals with age-related cognitive decline or dementia is rapidly increasing. Dairy product consumption, including β-lactolin, is beneficial for their cognitive function. The underlying mechanism of β-lactolin's effects on human brain activity is yet to be investigated. We examined the β-lactolin effects on human cerebral blood flow (CBF) using near-infrared spectroscopy (NIRS) in a placebo-controlled randomized double-blind study, which reported according to the CONSORT guidelines. Fifty healthy participants (aged 45-60 years) were randomly allocated into the β-lactolin or the placebo group (n = 25 each) and supplemented for 6 weeks. During the 6 th  week, oxy-hemoglobin during the working memory tasks was measured using 34-channels (CHs) NIRS. The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group. The oxy-Hb changes in CH23 have a co-relationship with the working memory task reaction time. This clinical trial showed an increase in the CBF in the left DLPFC area during the 6-week β-lactolin supplementation. This study contributes to elucidating the underlying mechanisms of β-lactolin on cognitive performance.",2020,"The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group.","['healthy adults', 'Fifty healthy participants (aged 45-60 years', 'elderly individuals with age-related cognitive decline or dementia']","['β-lactolin', 'placebo']","['cognitive performance', 'human cerebral blood flow (CBF', 'cerebral blood flow', 'changes of oxy-hemoglobin']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0236848', 'cui_str': 'Age-related cognitive decline'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",50.0,0.105533,"The changes of oxy-hemoglobin, which represents the CBF, in CH 23 located at the left dorsolateral prefrontal cortex (DLPFC) during the spatial working memory task showed higher statistical significance (false discovery rate ( q ) = 0.045) in the β-lactolin than in the placebo group.","[{'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Ano', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanazawa-ku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Kirin Central Research Institute, Kirin Holdings Company, Ltd., Kanazawa-ku, Yokohama 236-0004, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Hanyuda', 'Affiliation': 'Breast Health Clinic, Chuo-ku, Tokyo 103-0025, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, Aoba-ku, Sendai 980-0872, Japan.'}]",Aging,['10.18632/aging.103951']
2187,32986748,"Efficacy of processed amaranth-containing bread compared to maize bread on hemoglobin, anemia and iron deficiency anemia prevalence among two-to-five year-old anemic children in Southern Ethiopia: A cluster randomized controlled trial.","BACKGROUND


Few studies have evaluated iron-rich plant-based foods, such as amaranth grain, to reduce anemia and iron deficiency anemia. Amaranth is rich in nutrients, but with high level of phytate. The objective of this trial was to evaluate the efficacy of home processed amaranth grain containing bread in the treatment of anemia, hemoglobin concentration and iron deficiency anemia among two-to-five year-old children in Southern Ethiopia.
METHOD


Children with anemia (hemoglobin concentration <110.0g/L) (N = 100) were identified by random sampling and enrolled in a 1:1 cluster randomized controlled trial for six months in 2017. The amaranth group (N = 50), received 150g bread containing 70% amaranth and 30% chickpea, the amaranth grain was processed at home (soaking, germinating, and fermenting) to decrease the phytate level. The maize group (N = 50), received 150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread. Hemoglobin, ferritin, and CRP were measured at baseline and at the end of intervention. Hemoglobin and ferritin values were adjusted for altitude and infection, respectively. Generalized estimating equation and generalized linear model were used to analyze the data.
RESULT


In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR: 0.39 (95%CI: 0.16-0.77)]. Hemoglobin concentration estimate of beta coefficient was significantly higher in the amaranth group compared with the maize group [aβ 8.9g/L (95%CI: 3.5-14.3)], p-value <0.01. The risk of iron deficiency anemia is significantly lower in the amaranth group [aRR: 0.44 (95%CI: 0.23-0.83)] in the intention to treat analysis but not significant in the complete case analysis. There was no significant difference between groups in iron deficiency [aRR: 0.81 (95%CI: 0.55-1.19)].
CONCLUSION


Processed amaranth bread had favorable effects on hemoglobin concentration and has the potential to minimize anemia prevalence.
CLINICAL TRIAL REGISTRATION


Trial registry number: PACTR201705002283263 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2283.",2020,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","['two-to-five year-old children in Southern Ethiopia', 'Children with anemia (hemoglobin concentration <110.0g/L', 'two-to-five year-old anemic children in Southern Ethiopia']","['150g bread containing 70% amaranth and 30% chickpea, the amaranth grain', '150g bread, containing processed maize (roasted and fermented) to give a similar color and structure with amaranth bread', 'processed amaranth-containing bread compared to maize bread', 'home processed amaranth grain containing bread']","['Hemoglobin concentration estimate of beta coefficient', 'Hemoglobin, ferritin, and CRP', 'anemia, hemoglobin concentration and iron deficiency anemia', 'risk of iron deficiency anemia', 'Hemoglobin and ferritin values', 'hemoglobin, anemia and iron deficiency anemia prevalence', 'iron deficiency [aRR: 0.81', 'hemoglobin concentration', 'anemia prevalence', 'risk ratios, aRR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",100.0,0.17653,"In the last follow-up measure anemia prevalence was significantly lower in the amaranth group (32%) as compared with the maize group (56%) [adjusted risk ratios, aRR:","[{'ForeName': 'Alemselam Zebdewos', 'Initials': 'AZ', 'LastName': 'Orsango', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Ingunn Marie S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0239192']
2188,32986758,Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study.,"OBJECTIVE


This study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
MATERIALS AND METHODS


In this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.
RESULTS


Enrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).
CONCLUSION


In this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03806218).",2020,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","['eligible patients with recurrent HCC after locoregional treatment, to receive', 'recurrent hepatocellular carcinoma after locoregional treatment', 'recurrent hepatocellular carcinoma (HCC) after locoregional treatment']","['Radiofrequency ablation using internally cooled wet electrodes', 'TICW-RFA or SC-RFA', 'SC-RFA', 'bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes', 'TICW-RFA']","['minimum diameter of the ablation zone per unit ablation time', 'technique efficacy rates', 'technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes', 'Technical success', '1-year and 2-year cumulative LTP rates', 'Total RF energy delivery', 'energy delivery per unit time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861876', 'cui_str': 'Hepatocellular carcinoma recurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.066154,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","[{'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239733']
2189,32991303,Coping Skills Mobile App to Support the Emotional Well-Being of Young People During the COVID-19 Pandemic: Protocol for a Mixed Methods Study.,"BACKGROUND


The COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access.
OBJECTIVE


The Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand.
METHODS


A two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Māori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months.
RESULTS


The study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes.
CONCLUSIONS


There is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/23716.",2020,"Mental health and wellbeing apps represent a scalable approach for improving psychological outcomes in young people and have the potential to improve equity of service access.
","['young people', 'New Zealand young people', '90 young people aged 16-30 years', '20 young people aged 16-30 years (including those of Māori and Pacific ethnicity', 'young people in New Zealand and internationally', 'Methods', 'Participants for both study phases will be recruited via social media and online communities', 'Young People']",[],"['mental/emotional wellbeing and reducing depression, anxiety and stress', 'anxiety and distress']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.0963207,"Mental health and wellbeing apps represent a scalable approach for improving psychological outcomes in young people and have the potential to improve equity of service access.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kiralee', 'Initials': 'K', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wallace-Boyd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brenton-Peters', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Buttenshaw', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chadd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cao', 'Affiliation': 'Tamaki Health, Auckland, New Zealand.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morunga', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Hiran', 'Initials': 'H', 'LastName': 'Thabrew', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/23716']
2190,32991946,The feasibility of a personality targeted intervention for addictive overeating: FoodFix.,"Recent reviews have identified potential treatment targets for addictive overeating. These include: motivational interviewing, development of specific coping strategies for emotional regulation and the use of harm minimisation strategies based on interventions for substance use disorders. However, there is very little experiential evidence. The aim of this study was to determine the feasibility of a personality-targeted motivational interviewing intervention in adults above the healthy-weight range with symptoms of addictive eating, to reduce symptoms of addictive overeating and improve dietary profiles. Individuals with overweight and obesity (BMI >25 kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS) were recruited to a three-session intervention held over 3 months. Sessions were conducted by telehealth and facilitated by dietitians. Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ± 12.2yrs, mean BMI 36.7 ± 6.8 kg/m 2 , 96% female). At three month follow up, there were significant reductions from baseline (BL) for both groups in total YFAS 2.0 symptoms, however, these changes were not significantly different between groups (intervention BL 8.0 ± 2.7; 3-months 6.5 ± 3.8, control BL 8.1 ± 2.5; 3-months 6.9 ± 3.9, p > 0.05). At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p < 0.01). The FoodFix intervention provides insight to the development of future management interventions for addictive eating.",2020,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","['Individuals with overweight and obesity (BMI >25kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS', 'Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ±12.2yrs, mean BMI 36.7±6.8kg/m 2 , 96% female', 'adults above the healthy-weight range with symptoms of addictive eating']","['personality-targeted motivational interviewing intervention', 'FoodFix intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],52.0,0.0215587,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: Tracy.Burrows@newcastle.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: rebecca.collins10@newcastle.edu.au.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: megan.rollo@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: mark.leary@uon.edu.au.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, NSW, Australia. Electronic address: l.hides@uq.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, Canada. Electronic address: cdavis@yorku.ca.'}]",Appetite,['10.1016/j.appet.2020.104974']
2191,32992020,Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.,"Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.",2020,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.",['non-Hispanic black and white adults with knee osteoarthritis'],"['mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS', 'mindfulness meditation combined with transcranial direct current stimulation']","['Knee osteoarthritis (OA', 'Pain relief', 'clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",,0.077445,"After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months.","[{'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry & Behavioral Science, University of Florida, Gainesville, FL, USA; Pain Research & Intervention Center of Excellence, University of Florida, Gainesville, FL, USA. Electronic address: rfilling@ufl.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Nursing Systems, University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Radiation Oncology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Deshpande', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Deutsch', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Sibille', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Anesthesiology and Center for Mindfulness, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Burel R', 'Initials': 'BR', 'LastName': 'Goodin', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106159']
2192,32990370,Efficacy and tolerability of 20% aluminum sesquichlorohydrate vs 20% aluminum chloride for the treatment of axillary hyperhidrosis: A randomized controlled trial.,"This study evaluated the efficacy and tolerability of topical aluminum sesquichlorohydrate (AS) when compared to aluminum chloride (AC) as a treatment for primary axillary hyperhidrosis (PAH). Twenty subjects were included in this randomized, controlled, split-side 8-week study. All participants applied 20% AS and 20% AC lotions in their axillae (one treatment per axilla) every night for 2 weeks; next, the application was reduced to three times a week for 4 weeks. The assessment was performed using the sweating intensity visual scale (SIVS), hyperhidrosis disease severity score (HDSS), patient satisfaction score, and the appearance of adverse effects on weeks 0, 1, 2, 4, 6, and 8. Both AS as well as AC application showed positive results, significantly differing from the baseline, as assessed using SIVS, HDSS, and patient satisfaction score at every follow-up visit; however, no significant difference was observed between the AS and AC groups at any follow-up visit. The mean time of response was 1.14 weeks for both treatments. A side effect was observed in one subject (5%), who reported itching on the AC axilla. The therapeutic effects persisted even after reducing the frequency of application and lasted for at least 2 weeks after cessation of use. In conclusion, topical 20% AS demonstrated similar efficacy to topical 20% AC in the treatment of PAH, with a high safety profile.",2020,"Both AS as well as AC application showed positive results, significantly differing from the baseline, as assessed using SIVS, HDSS, and patient satisfaction score at every follow-up visit; however, no significant difference was observed between the AS and AC groups at any follow-up visit.","['Twenty subjects', 'Axillary Hyperhidrosis', 'primary axillary hyperhidrosis']","['aluminum chloride (AC', 'topical aluminum sesquichlorohydrate (AS', 'Aluminum Sesquichlorohydrate vs 20% Aluminum Chloride']","['mean time of response', 'Efficacy and Tolerability', 'SIVS, HDSS, and patient satisfaction score', 'sweating intensity visual scale (SIVS), hyperhidrosis disease severity score (HDSS), patient satisfaction score, and the appearance of adverse effects', 'efficacy and tolerability']","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1588587', 'cui_str': 'aluminum sesquichlorohydrate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",20.0,0.032532,"Both AS as well as AC application showed positive results, significantly differing from the baseline, as assessed using SIVS, HDSS, and patient satisfaction score at every follow-up visit; however, no significant difference was observed between the AS and AC groups at any follow-up visit.","[{'ForeName': 'Thianthong', 'Initials': 'T', 'LastName': 'Thianboonsong', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsee', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Anon', 'Initials': 'A', 'LastName': 'Paichitrojjana', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Montree', 'Initials': 'M', 'LastName': 'Udompataikul', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Nanticha', 'Initials': 'N', 'LastName': 'Kamanamool', 'Affiliation': 'Department of Preventive and Social Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Salinee', 'Initials': 'S', 'LastName': 'Rojhirunsakool', 'Affiliation': 'Skin Center, Srinakharinwirot University, Bangkok, Thailand.'}]",Dermatologic therapy,['10.1111/dth.14354']
2193,32988954,Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial.,"BACKGROUND


In a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.
OBJECTIVE


To do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.
SETTING


14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.
PARTICIPANTS


A subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.
INTERVENTION


Washing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.
OUTCOME MEASURE


Infection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.
RESULTS


Viral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
CONCLUSIONS


Using self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.
TRIAL RESGISTRATION NUMBER


ACTRN12610000887077.",2020,"There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
","['hospital healthcare workers (HCWs', 'hospital health workers in Vietnam', '14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam', 'A subgroup of 607 HCWs aged ≥18\u2009years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks']",['Washing method for cloth masks (self-washing or hospital laundry'],"['Infection rate', 'risk of infection', 'infection']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",607.0,0.072564,"There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).
","[{'ForeName': 'Chandini Raina', 'Initials': 'CR', 'LastName': 'MacIntyre', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia rainam@protonmail.com.'}, {'ForeName': 'Tham Chi', 'Initials': 'TC', 'LastName': 'Dung', 'Affiliation': 'Ministry of Health, Vietnam, Hanoi, Viet Nam.'}, {'ForeName': 'Abrar Ahmad', 'Initials': 'AA', 'LastName': 'Chughtai', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Seale', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bayzidur', 'Initials': 'B', 'LastName': 'Rahman', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-042045']
2194,32986652,"An 18-month follow-up study on the effect of a neuromuscular stabilization technique on Cobb's angle in adolescent idiopathic scoliosis: A single-blind, age-matched controlled trial.","BACKGROUND


The benefits of spinal realignment and stabilization in scoliosis need to be examined.
OBJECTIVE


We aimed to investigate the long-term effect of a neuromuscular stabilization technique (NST) on Cobb's angle in patients with adolescent idiopathic scoliosis.
METHODS


Twenty females recruited from two hospitals participated in this study. On the basis of convenience of location, participants were allocated to either the experimental group (EG) that underwent the NST, or the control group (CG) that received education for a home exercise program. The NST for the EG was performed for an average of 30 min per session, three times a week for six months, and consisted of spinal realignment and stabilization. Then, 12- and 18-month measurements for long-term follow-ups were conducted for the EG. The outcome measure was Cobb's angle.
RESULTS


Between-group comparison revealed a statistically significant difference at post-test (t=-3.26, p< 0.01) but not pre-test (t=-1.36, p= 0.19). Participants of the EG (-6.20 ± 2.49∘) showed greater differences between pre- and post-test scores compared to participants of the CG (-1.40 ± 0.52∘) (p< 0.05). Within-group comparisons showed a significant difference in both groups (p< 0.05). In the EG, Cobb's angle significantly changed across the follow-up sessions (p< 0.05), indicating more improvements by the 12-month (8.50 ± 4.03∘) and 18-month (6.60 ± 3.89∘) follow-ups.
CONCLUSION


This study shows that the NST may be a beneficial option to correct spinal alignments in patients with adolescent idiopathic scoliosis.",2020,"In the EG, Cobb's angle significantly changed across the follow-up sessions (p< 0.05), indicating more improvements by the 12-month (8.50 ± 4.03∘) and 18-month (6.60 ± 3.89∘) follow-ups.
","['Twenty females recruited from two hospitals participated in this study', 'adolescent idiopathic scoliosis', 'patients with adolescent idiopathic scoliosis']","['NST, or the control group (CG) that received education for a home exercise program', 'neuromuscular stabilization technique', 'NST', 'neuromuscular stabilization technique (NST']","[""Cobb's angle""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0563192', 'cui_str': 'Cobb angle'}]",20.0,0.046784,"In the EG, Cobb's angle significantly changed across the follow-up sessions (p< 0.05), indicating more improvements by the 12-month (8.50 ± 4.03∘) and 18-month (6.60 ± 3.89∘) follow-ups.
","[{'ForeName': 'Sang-Hee', 'Initials': 'SH', 'LastName': 'Won', 'Affiliation': 'NCR Sling Exercise Center, Dongtan, Korea.'}, {'ForeName': 'Duck-Won', 'Initials': 'DW', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Cheongju, Korea.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'Shanghai Rehabilitation and Vocational Training Center for the Disabled, Shanghai, China.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191559']
2195,32986655,"The effects of clinical pilates exercises on functional disability, pain, quality of life and lumbopelvic stabilization in pregnant women with low back pain: A randomized controlled study.","BACKGROUND


Although the Pilates method has been reported to be effective in women with low back pain (LBP), the efficacy of Pilates exercises in pregnant women with LBP has not been evaluated widely.
OBJECTIVE


The purpose of this study was to determine the effects of clinical Pilates exercises on lumbopelvic stabilization, pain, disability and quality of life in pregnant women with LBP.
METHODS


Fourty pregnant women were randomized into either a Pilates exercise group (n= 20) or control group (n= 20). Subjects in the Pilates exercise group performed the exercises two times a week for eight weeks. Subjects in the control group followed regular prenatal care. Lumbopelvic stabilization was assessed with a pressure biofeedback unit, pain with the Visual Analog Scale, disability with the Oswestry Low Back Pain Questionnaire and quality of life with the Nottingham Health Profile (NHP).
RESULTS


Pain and disability were significantly improved in the Pilates exercise group after intervention (p= 0.03, p< 0.001, respectively). There were also significant improvements in sleep, physical mobility sub-parameters of NHP and lumbopelvic stabilization after Pilates exercises (p= 0.048, p= 0.007, respectively). However, there were no statistically significant changes in all outcome measures in the control group (p> 0.05).
CONCLUSIONS


Pilates exercises can be recommended as an effective and safe method for increasing lumbopelvic stabilization, reducing pain and disability, improving physical mobility and sleep problems in pregnant women with LBP.",2020,"There were also significant improvements in sleep, physical mobility sub-parameters of NHP and lumbopelvic stabilization after Pilates exercises (p= 0.048, p= 0.007, respectively).","['women with low back pain (LBP', 'pregnant women with low back pain', 'pregnant women with LBP', 'Fourty pregnant women']","['clinical pilates exercises', 'Pilates exercise', 'clinical Pilates exercises', 'regular prenatal care']","['Pain and disability', 'pain and disability, improving physical mobility and sleep problems', 'Lumbopelvic stabilization', 'pressure biofeedback unit, pain with the Visual Analog Scale, disability with the Oswestry Low Back Pain Questionnaire and quality of life with the Nottingham Health Profile (NHP', 'sleep, physical mobility sub-parameters of NHP and lumbopelvic stabilization', 'lumbopelvic stabilization, pain, disability and quality of life', 'functional disability, pain, quality of life and lumbopelvic stabilization']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0582461,"There were also significant improvements in sleep, physical mobility sub-parameters of NHP and lumbopelvic stabilization after Pilates exercises (p= 0.048, p= 0.007, respectively).","[{'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Sonmezer', 'Affiliation': ''}, {'ForeName': 'Manolya Acar', 'Initials': 'MA', 'LastName': 'Özköslü', 'Affiliation': ''}, {'ForeName': 'Hayri Baran', 'Initials': 'HB', 'LastName': 'Yosmaoğlu', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191810']
2196,32991652,Sinus Floor Elevation with Biphasic Calcium Phosphate or Deproteinized Bovine Bone Mineral: Clinical and Histomorphometric Outcomes of a Randomized Controlled Clinical Trial.,"PURPOSE


To clinically and histomorphometrically compare a biphasic calcium phosphate (BCP) and deproteinized bovine bone mineral (DBBM) for sinus floor elevation.
MATERIALS AND METHODS


Sinus floor elevation procedures (lateral window) were performed randomly applying either BCP (test) or DBBM (control). At 6 months, bone biopsy specimens were harvested and dental implants were placed. The proportions of new bone, residual grafting material, and nonmineralized soft tissue were calculated. Four months after implant placement, the prosthetic reconstructions were inserted and the implant survival was assessed.
RESULTS


Fifty-one patients were treated; 25 were randomly allocated to the BCP group and 26 to the DBBM group. After 6 months in 50 patients, bone biopsy specimens could be harvested, and a total of 121 implants could be placed subsequently. The histomorphometric analysis revealed a comparable percentage of new bone in both groups (BCP 35.9%, DBBM 35.4%; P > .05). The remaining grafting material was significantly lower with BCP (25.3%) compared with DBBM (45.9%; P < .001). Nonmineralized tissue was significantly higher for the BCP group (38.1%) compared with the DBBM group (18.2%; P < .001). The implant survival rate at loading was assessed at the level of the patients (96.0% for BCP and 88.8% for DBBM; P > .05) and at the level of the implants (96.9% for BCP and 94.7% for DBBM; P > .05).
CONCLUSION


Grafting with DBBM or BCP showed similar percentages of new bone 6 months after sinus floor elevation. Implant survival presented no significant difference until loading.",2020,Nonmineralized tissue was significantly higher for the BCP group (38.1%) compared with the DBBM group (18.2%; P < .001).,"['Sinus floor elevation procedures (lateral window', 'Fifty-one patients were treated; 25']","['BCP (test) or DBBM (control', 'DBBM or BCP', 'Biphasic Calcium Phosphate or Deproteinized Bovine Bone Mineral', 'BCP', 'biphasic calcium phosphate (BCP) and deproteinized bovine bone mineral (DBBM']","['percentage of new bone', 'Nonmineralized tissue', 'implant survival rate at loading', 'BCP', 'Implant survival', 'implant survival']","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",51.0,0.0467492,Nonmineralized tissue was significantly higher for the BCP group (38.1%) compared with the DBBM group (18.2%; P < .001).,"[{'ForeName': 'Riccardo D', 'Initials': 'RD', 'LastName': 'Kraus', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Stricker', 'Affiliation': ''}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': ''}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.8211']
2197,32991656,Three-Dimensional Evaluation of Peri-implant Soft Tissue When Tapered Implants Are Placed: Pilot Study with Implants Placed Immediately or Early Following Tooth Extraction.,"PURPOSE


This study examined a new 3D volumetric analysis method for the assessment of baseline-to-12-month changes of the soft tissue volume at early and immediately placed tapered implants after loading with ceramic single crowns.
MATERIALS AND METHODS


Eligible patients with one incisor, canine, or premolar to be extracted were included. The patients were divided randomly into early-placement or immediate-placement groups. Tapered implants (BLT, Institut Straumann) were placed after the extractions. In the early-placement group, the implants were placed 8 weeks after extraction. In the immediate-placement group, the implants were placed immediately after the extraction. All implants healed transmucosally, and the final crowns were inserted after healing (baseline). Impressions were made at screening, baseline, and 12 months after crown insertion (Permadyne, 3M). The casts were scanned (Imetric 4D) and aligned, and a superimposed area of interest (AOI) (labial/buccal aspects) was defined to assess the volumetric changes (GOM Inspect). Specific software (3Matic, Materialise NV) was used for volumetric analysis. The vertical mucosal recession was measured at each time point. Repeated-measures one-way analysis of variance and the Tukey method were used for statistical analysis (SPSS 22, IBM).
RESULTS


Twenty tapered implants (16 regular and four narrow) were placed in 20 patients (12 men and 8 women) in the early-placement (EP; n = 10) and immediate-placement (IP; n = 10) groups, respectively. Threedimensional volumetric analysis revealed soft tissue volume loss in both groups of 10.0 ± 16.5 mm 3  (EP) and 24.3 ± 21.3 mm 3  (IP) between baseline and 12 months (P = .6). The analysis also revealed local differences in the changes, displaying both localized gain and loss in both groups.
CONCLUSION


With this novel 3D analysis method, true volumetric soft tissue differences, ie, both localized gain and loss, were specified between the treatment groups.",2020,Threedimensional volumetric analysis revealed soft tissue volume loss in both groups of 10.0 ± 16.5 mm 3  (EP) and 24.3 ± 21.3 mm 3  (IP) between baseline and 12 months (P = .6).,"['Twenty tapered implants (16 regular and four narrow) were placed in 20 patients (12 men and 8 women) in the early-placement (EP; n = 10) and immediate-placement (IP; n = 10) groups, respectively', 'Eligible patients with one incisor, canine, or premolar to be extracted were included']",['Peri-implant Soft Tissue'],"['vertical mucosal recession', 'soft tissue volume loss']","[{'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0522403,Threedimensional volumetric analysis revealed soft tissue volume loss in both groups of 10.0 ± 16.5 mm 3  (EP) and 24.3 ± 21.3 mm 3  (IP) between baseline and 12 months (P = .6).,"[{'ForeName': 'Hyeonjong', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fehmer', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hicklin', 'Affiliation': ''}, {'ForeName': 'Gunwoo', 'Initials': 'G', 'LastName': 'Noh', 'Affiliation': ''}, {'ForeName': 'Seoung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Sailer', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7879']
2198,32993343,Vitamin E-doped total hip arthroplasty liners show similar head penetration to highly cross-linked polyethylene at five years: a multi-arm randomized controlled trial.,"AIMS


The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).
METHODS


Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.
RESULTS


Of 220 screened patients, 127 were included in this study. In all, 116 received the allocated intervention, and 94 had their results analyzed at five years. Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively. No differences were found in acetabular component migration or in the patient-reported outcome measures.
CONCLUSION


No significant difference in head penetration was found at five years between vE-PE and XLPE liners, nor between 32 mm and 36 mm heads. Cite this article:  Bone Joint J  2020;102-B(10):1303-1310.",2020,"Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively.","['Patients scheduled for a THA', '220 screened patients']","['vE-PE or XLPE liner with a 32 mm or 36 mm metal head', 'Vitamin E-doped total hip arthroplasty liners', 'cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters']","['head penetration', 'Harris Hip Score, University of California, Los Angeles (UCLA', 'Head penetration and acetabular component migration', 'acetabular component migration', 'Head penetration', 'Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.243059,"Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kjærgaard', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bragdon', 'Affiliation': 'Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Malchau', 'Affiliation': 'Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Andreasen', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Ovesen', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hofbauer', 'Affiliation': 'Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0138.R1']
2199,32993256,[Effects of patient-controlled intravenous analgesia with butorphanol versus sufentanil on early postoperative rehabilitation following radical laparoscopic nephrectomy].,"Objective:  To investigate the effects of patient-controlled intravenous analgesia with butorphanol versus sufentanil on early postoperative rehabilitation following radical laparoscopic nephrectomy.  Methods:  One hundred patients undergoing radical laparoscopic nephrectomy in Affiliated Cancer Hospital of Zhengzhou University from September 2018 to February 2020 were divided into two groups ( n =50) using a random number table: butorphanol patient-controlled intravenous analgesia group (group A) and sufentanil patient-controlled intravenous analgesia group (group B). Patient-controlled intravenous analgesia (PCIA) was performed at the end of surgery. The formulation of group A was butorphanol (0.15 mg/kg) and ketorolac tromethamine (180 mg) using the physiological saline at a dilution of 100 ml. The formulation of group B was sufentanil (1.5 μg/kg) and ketorolac tromethamine (180 mg) using the physiological saline at a dilution of 100 ml. At the time points of 4, 8, 24, 48 h after operation (T(1), T(2), T(3), T(4)), VAS scores at rest and cough were recorded. The incidence of remedial analgesia, the number of pressings during 48 h after the operation, the postoperative anal exhaust recovery time of the patients were recorded. Quality of recovery-40(QoR-40) scores were recorded at T(3) and T(4). Adverse reactions were recorded.  Results:  There was no significant difference in VAS scores at rest and cough at T(1), T(2), T(3) and T(4) between two groups (all  P >0.05). There was no significant difference in the incidence of remedial analgesia and the number of pressings during 48 h after the operation between two groups (all  P >0.05). The postoperative anal exhaust recovery time of the patients in group A was (32±6) h, which was lower than that in group B with statistically significant difference [(40±5) h,  t =7.937,  P <0.01]. The QoR-40 total scores in group A were higher than those in group B at T(3) and T(4), which were (185.8±2.5) vs (170.7±2.7), (194.8±1.9) vs (183.6±2.6), and the differences were statistically significant ( t =28.878, 25.025, all  P <0.01). The incidence of nausea, retching/vomiting, respiratory depression and itch during 48 h after the operation in group A were 10%, 6%, 2%, 2%, which were lower than that in group B (32%, 20%, 14%, 18%), with statistically significant difference (χ(2)=7.294, 4.322, 4.891, 5.983, all  P <0.05).  Conclusion:  PCIA with butorphanol or sufentanil can provide satisfactory analgesia for patients undergoing radical laparoscopic nephrectomy, but butorphanol can promote postoperative rehabilitation with fewer adverse reactions.",2020,"There was no significant difference in VAS scores at rest and cough at T(1), T(2), T(3) and T(4) between two groups (all  P >0.05).","['patients undergoing radical laparoscopic nephrectomy', 'One hundred patients undergoing', 'in Affiliated Cancer Hospital of Zhengzhou University from September 2018 to February 2020', 'radical laparoscopic nephrectomy']","['sufentanil', 'butorphanol', 'butorphanol patient-controlled intravenous analgesia group', 'ketorolac tromethamine', 'butorphanol or sufentanil', 'sufentanil patient-controlled intravenous analgesia', 'physiological saline', 'Patient-controlled intravenous analgesia (PCIA', 'radical laparoscopic nephrectomy']","['operation (T(1), T(2), T(3), T(4)), VAS scores at rest and cough', 'early postoperative rehabilitation', 'incidence of nausea, retching/vomiting, respiratory depression and itch during 48 h after the operation', 'Quality of recovery-40(QoR-40) scores', 'QoR-40 total scores', 'Adverse reactions', 'VAS scores at rest and cough at T(1), T(2), T(3) and T(4', 'incidence of remedial analgesia, the number of pressings', 'postoperative anal exhaust recovery time', 'incidence of remedial analgesia and the number of pressings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0064326', 'cui_str': 'Ketorolac tromethamine'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",100.0,0.0591357,"There was no significant difference in VAS scores at rest and cough at T(1), T(2), T(3) and T(4) between two groups (all  P >0.05).","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Lyu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'X T', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200616-01866']
2200,32993338,Addition of corticosteroid to periarticular injections reduces postoperative pain following total hip arthroplasty under general anaesthesia: a double-blind randomized controlled trial.,"AIMS


Although periarticular injection plays an important role in multimodal pain management following total hip arthroplasty (THA), there is no consensus on the optimal composition of the injection. In particular, it is not clear whether the addition of a corticosteroid improves the pain relief achieved nor whether it is associated with more complications than are observed without corticosteroid. The aim of this study was to quantify the safety and effectiveness of cortocosteroid use in periarticular injection during THA.
METHODS


We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. A total of 187 patients were randomly assigned to receive periarticular injection containing either a corticosteroid (CS group) or without corticosteroid (no-CS group). Other perioperative interventions were identical for all patients. The primary outcome was postoperative pain at rest during the initial 24 hours after surgery. Pain score was recorded every three hours until 24 hours using a 100 mm visual analogue scale (VAS). The primary outcome was assessed based on the area under the curve (AUC).
RESULTS


The CS group had a significantly lower AUC postoperatively at 0 to 24 hours compared to the no-CS group (AUC of VAS score at rest 550 ± 362 vs 392 ± 320, respectively; mean difference 158 mm; 95% confidence interval (CI) 58 to 257; p = 0.0021). In point-by-point evaluation, the CS group had significantly lower VAS scores at 12, 15, 18, 21, 24, and 48 hours. There were no significant differences in complication rates, including surgical site infection, between the two groups.
CONCLUSION


The addition of corticosteroid to periarticular injections reduces postoperative pain without increasing complication rate following THA. Cite this article:  Bone Joint J  2020;102-B(10):1297-1302.",2020,"There were no significant differences in complication rates, including surgical site infection, between the two groups.
","['A total of 187 patients', 'patients scheduled for unilateral THA', 'total hip arthroplasty under general anaesthesia', 'total hip arthroplasty (THA']","['corticosteroid to periarticular injections', 'periarticular injection containing either a corticosteroid (CS group) or without corticosteroid']","['postoperative pain at rest', 'complication rates, including surgical site infection', 'VAS scores', 'area under the curve (AUC', 'pain relief', 'safety and effectiveness', 'Pain score', 'postoperative pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",187.0,0.57545,"There were no significant differences in complication rates, including surgical site infection, between the two groups.
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kurosaka', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Sachiyuki', 'Initials': 'S', 'LastName': 'Tsukada', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Rehabilitation, Hokusuikai Kinen Hospital, Mito, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Orthopaedic Surgery, Nishinomiya Kaisei Hospital, Hyogo, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirasawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.'}]",The bone & joint journal,['10.1302/0301-620X.102B10.BJJ-2020-0428.R1']
2201,32989186,Effects of a Psychobiotic Supplement on Serum Brain-derived Neurotrophic Factor Levels in Depressive Patients: A  Post Hoc  Analysis of a Randomized Clinical Trial.,"Background/Aims


Psychobiotics are probiotics or prebiotics that, upon ingestion in adequate amounts, yield positive influence on mental health via microbiota-gut-brain axis regulation to modulate the circulating cytokines, chemokines, neurotransmitters, or neurotrophins levels. We have recently shown that a psychobiotic combination ( Lactobacillus helveticus  R0052 and  Bifidobacterium longum  R0175; CEREBIOME) significantly improved depression symptoms in patients with depression. Recent animal data suggest the influence of the gut microbiota on brain-derived neurotrophic factor (BDNF), which was shown to correlate with antidepressant response in depressive patients. Therefore, we conducted this exploratory  post hoc  analysis of BDNF levels to clarify the mechanism of action of this psychobiotic in our cohort.
Methods


Our study was a double-blind, randomized controlled trial of patients with low-to-moderate depression receiving either a probiotic combination, prebiotic or placebo. From the 110 patients randomized in the trial, 78 were included in this  post hoc  analysis (probiotic, n = 28; prebiotic and placebo, n = 25). We compared serum BDNF levels from participants at baseline and endpoint, and assessed the Pearson correlation between depression severity and BDNF levels for each intervention.
Results


We found that post-intervention BDNF levels were significantly different between groups ( P  < 0.001). Furthermore, BDNF levels increased significantly in the probiotic group compared to both the prebiotic ( P  < 0.001) and placebo groups ( P  = 0.021), which inversely correlated with depression severity compared to placebo (ANOVA/ANCOVA,  P  = 0.012; Pearson,  r  = -0.79,  P  < 0.001). In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
Conclusion


Eight-week supplementation with B. longum and L. helveticus in depressive patients improved depression symptoms, possibly by increasing BDNF levels.",2020,"In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
","['Depressive Patients', 'patients with depression', '110 patients randomized in the trial, 78 were included in this  post hoc  analysis (probiotic, n = 28; prebiotic and placebo, n = 25', 'depressive patients', 'patients with low-to-moderate depression receiving either a']","['probiotic combination, prebiotic or placebo', 'placebo', 'Psychobiotic Supplement']","['Serum Brain-derived Neurotrophic Factor Levels', 'BDNF levels', 'depression symptoms', 'depression severity', 'serum BDNF levels', 'post-intervention BDNF levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",110.0,0.598531,"In the prebiotic group, BDNF levels reduced but not significantly compared with placebo group ( P  > 0.05).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Heidarzadeh-Rad', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Gökmen-Özel', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Nutrition Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Almasi', 'Affiliation': 'Department of Nutrition and Dietetics, Hacettepe University Faculty of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20079']
2202,32989199,The effect of postoperatively applied far-infrared radiation on pain and tendon-to-bone healing after arthroscopic rotator cuff repair: a clinical prospective randomized comparative study.,"Background


The effects of far-infrared radiation (FIR) on the treatment of rotator cuff diseases remains unknown. We evaluated the safety and efficacy of FIR after arthroscopic rotator cuff repair with regard to postoperative pain and healing.
Methods


This prospective randomized comparative study included 38 patients who underwent arthroscopic rotator cuff repair due to a medium-sized tear. Patients were randomly divided into the FIR or control group (n = 19 per group). In the FIR group, FIR with an FIR radiator started 1 week postoperatively for 30 minutes per session twice daily. It lasted until abduction brace weaning at 5 weeks postoperatively. We assessed pain using a pain visual analogue scale (pVAS) and measured the range of motion (ROM) of the shoulder at 5 weeks, and 3 and 6 months, postoperatively. The anatomical outcome was evaluated using magnetic resonance imaging at 6 months postoperatively.
Results


At 5 weeks postoperatively, the average pVAS score was lower in the FIR group than in the control group (1.5 ± 0.8  vs.  2.7 ± 1.7;  P  = 0.019). At 3 months postoperatively, the average forward flexion was higher in the FIR group (151.6° ± 15.3°  vs.  132.9° ± 27.8°;  P  = 0.045), but there was no significant difference at 6 months postoperatively. There was no significant difference in healing failure between the groups ( P  = 0.999).
Conclusions


FIR after arthroscopic rotator cuff repair could be an effective and safe procedure to reduce postoperative pain, thereby facilitating rehabilitation and better ROM in the early postoperative period.",2020,"At 5 weeks postoperatively, the average pVAS score was lower in the FIR group than in the control group (1.5 ± 0.8  vs.  2.7 ± 1.7;  P  = 0.019).","['38 patients who underwent arthroscopic rotator cuff repair due to a medium-sized tear', 'after arthroscopic rotator cuff repair']",['infrared radiation (FIR'],"['healing failure', 'pain and tendon-to-bone healing', 'average pVAS score', 'average forward flexion', 'safety and efficacy of FIR', 'pain using a pain visual analogue scale (pVAS) and measured the range of motion (ROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",38.0,0.0304296,"At 5 weeks postoperatively, the average pVAS score was lower in the FIR group than in the control group (1.5 ± 0.8  vs.  2.7 ± 1.7;  P  = 0.019).","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, National Police Hospital, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Bundang Jesaeng Genenral Hospital, Seongnam, Korea.'}, {'ForeName': 'Kwang Jin', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Department of Orthopaedic Surgery, Sun's Hospital, Seoul, Korea.""}, {'ForeName': 'Hyong Suk', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Incheon Sarang Hospital, Incheon, Korea.'}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Rhee', 'Affiliation': 'Department of Orthopeadic Surgery, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.4.344']
2203,32989202,"The analgesic efficacy of a single injection of ultrasound-guided retrolaminar paravertebral block for breast surgery: a prospective, randomized, double-blinded study.","Background


The thoracic paravertebral block is an effective analgesic technique for postoperative pain management after breast surgery. The ultrasound-guided retrolaminar block (RLB) is a safer alternative to conventional paravertebral block. Thus, we assessed the analgesic efficacy of ultrasound-guided RLB for postoperative pain management after breast surgery.
Methods


Patients requiring breast surgery were randomly allocated to group C (retrolaminar injection with saline) and group R (RLB with local anesthetic mixture). The RLB was performed at the level of T3 with local anesthetic mixture (0.75% ropivacaine 20 mL + 2% lidocaine 10 mL) under general anesthesia before the skin incision. The primary outcome was cumulative morphine consumption using intravenous patient-controlled analgesia (IV-PCA) at 24 hour postoperatively. The secondary outcomes were the visual analogue scale (VAS) scores at 1, 6, 24, and 48 hour postoperatively and the occurrence of adverse events and patient satisfaction after the surgery.
Results


Forty-six patients were included, 24 in group C and 22 in group R. The cumulative morphine consumption using IV-PCA did not differ between the two groups ( P  = 0.631). The intraoperative use of remifentanil was higher in group C than in group R ( P  = 0.025). The resting and coughing VAS scores at 1 hour postoperatively were higher in group R than in group C ( P  = 0.011,  P  = 0.004). The incidence of adverse events and patient satisfaction was not significantly different between the two groups.
Conclusions


A single injection of ultrasound-guided RLB did not reduce postoperative analgesic requirements following breast surgery.",2020,The cumulative morphine consumption using IV-PCA did not differ between the two groups ( P  = 0.631).,"['breast surgery', 'Forty-six patients were included, 24 in group C and 22 in group R', 'Patients requiring breast surgery']","['ultrasound-guided RLB', 'C (retrolaminar injection with saline) and group R (RLB with local anesthetic mixture', 'ultrasound-guided retrolaminar block (RLB', 'ropivacaine 20 mL + 2% lidocaine', 'single injection of ultrasound-guided retrolaminar paravertebral block', 'remifentanil']","['cumulative morphine consumption using intravenous patient-controlled analgesia (IV-PCA', 'postoperative analgesic requirements', 'cumulative morphine consumption', 'incidence of adverse events and patient satisfaction', 'resting and coughing VAS scores', 'visual analogue scale (VAS) scores', 'occurrence of adverse events and patient satisfaction', 'analgesic efficacy']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441852', 'cui_str': 'Group R'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",46.0,0.213401,The cumulative morphine consumption using IV-PCA did not differ between the two groups ( P  = 0.631).,"[{'ForeName': 'Boo-Young', 'Initials': 'BY', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Eunsoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Dowon', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Pusan National University School of Medicine, Yangsan, Korea.'}, {'ForeName': 'Taewoo', 'Initials': 'T', 'LastName': 'Kang', 'Affiliation': 'Department of Busan Cancer Center (Breast Cancer Clinic), Pusan National University Hospital, Busan, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.4.378']
2204,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND


Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS


The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS


INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
2205,32992107,Disseminating trial results: We can have both faster and better.,,2020,,[],[],[],[],[],[],,0.0376918,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Gregory.E.Simon@kp.org.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Richesson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100474']
2206,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE


This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD


CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS


The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION


This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
2207,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND


Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS


We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS


The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS


IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
2208,32992159,Is directed open-glottis pushing more effective than directed closed-glottis pushing during the second stage of labor? A pragmatic randomized trial - the EOLE study.,"OBJECTIVE


To compare the effectiveness of directed open-glottis and directed closed-glottis pushing.
DESIGN


Pragmatic, randomised, controlled, non-blinded superiority study.
SETTINGS


Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals).
PARTICIPANTS


250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group. The exclusion criteria were previous caesarean birth or fetal heart rate anomaly. Participants were randomised during labour, after a cervical dilation ≥ 7 cm.
INTERVENTIONS


In the intervention group, open-glottis pushing was defined as a prolonged exhalation contracting the abdominal muscles (pulling the stomach in) to help move the fetus down the birth canal. Closed-glottis pushing was defined as Valsalva pushing.
MEASUREMENTS


The principal outcome was ""effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion. The results in our intention-to-treat analysis are reported as crude relative risks (RR) with their 95% confidence intervals. A multivariable analysis was used to take the relevant prognostic and confounding factors into account and obtain an adjusted relative risk (aRR).
FINDINGS


In our intention-to-treat analysis, most characteristics were similar across groups including epidural analgesia (>95% in each group). The mean duration of the expulsion phase was longer among the open-glottis group (24.4 min ± 17.4 vs. 18.0 min ± 15.0, p=0.002). The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
KEY CONCLUSIONS


In maternity units with a high rate of epidural analgesia, the effectiveness of the type of directed pushing does not appear to differ between the open- and closed-glottis groups.
IMPLICATIONS FOR PRACTICE


If directed pushing is necessary, women should be able to choose the type of directed pushing they prefer to use during birth. Professionals must therefore be trained in both types so that they can adequately support women as they give birth.",2020,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","['Four French hospitals between July 2015 and June 2017 (2 academic hospitals and 2 general hospitals', '250 women in labour who had undergone standardised training in the two types of pushing with a singleton fetus in cephalic presentation at term (≥37 weeks) were included by midwives and randomised; 125 were allocated to each group']",['directed open-glottis and directed closed-glottis pushing'],"['mean duration of the expulsion phase', 'effectiveness of pushing"" defined as a spontaneous birth without any episiotomy, second-, third-, or fourth-degree perineal lesion', 'effectiveness of their pushing', 'epidural analgesia', 'caesarean birth or fetal heart rate anomaly']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",250.0,0.172721,"The two groups did not appear to differ in the effectiveness of their pushing (48.0% in the open-glottis group versus 55.2% in the closed-glottis group, for an adjusted relative risk (aRR) of 0.92, 95% confidence interval (CI) 0.74-1.14) or in their risk of instrumental birth (aRR 0.97, 95%CI 0.85-1.10).
","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Barasinski', 'Affiliation': 'Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France. Electronic address: cbarasinski@chu-clermontferrand.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Debost-Legrand', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France.""}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Vendittelli', 'Affiliation': ""Université Clermont Auvergne, CHU, CNRS, SIGMA Clermont, Institut Pascal, F-63000, CLERMONT-FERRAND, France; Réseau de Santé en Périnatalité d'Auvergne, F-63000, Clermont-Ferrand, France; AUDIPOG (Association des Utilisateurs de Dossiers Informatisés en Pédiatrie, Obstétrique et Gynécologie), RTH Laennec Medical University, 7 rue Guillaume Paradin, 69372, Lyon Cedex 08, France.""}]",Midwifery,['10.1016/j.midw.2020.102843']
2209,32992184,Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND


Local vibration can improve balance problems of individuals with stroke when applied to the plantar region.
AIMS


This study aimed to determine the immediate effect of local vibration applied to the plantar region on fall risk and postural stability in patients with stroke.
STUDY DESIGN


Randomized controlled study.
METHODS


30 patients (23 male,7 female) with stroke were randomized to either vibration (n = 15; 58.47 ± 8.23 years) or control (n = 15; 58.27 ± 9.50 years) groups. Before and after the intervention, the patients were evaluated using a Biodex Balance System. Local vibration was applied to the plantar region of two feet in the supine position using a vibration device for a total of 15 min to the individuals in the vibration group. While the patients in the placebo group were in the supine position, the device was brought into contact and no vibration was applied to the plantar region of two feet for 15 min.
RESULTS


While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05). Furthermore, significant improvements occurred in the SD values of the postural stability expressing postural oscillation in the vibration group (p < 0.05).
CONCLUSION


As a result of local vibration applied to the plantar region, immediate (within 5 min) significant improvements in postural stability and fall risk values were detected.",2020,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","['individuals with stroke', '30 patients (23 male,7 female) with stroke', 'Stroke Patients', 'patients with stroke']","['placebo', 'local vibration', 'Plantar Vibration', 'vibration']","['fall risk and postural stability', 'SD values of the postural stability expressing postural oscillation', 'postural stability and fall risk', 'postural stability and fall risk values', 'Fall Risk and Postural Stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",30.0,0.0194722,"While significant improvements were observed in the postural stability and fall risk of the vibration group (p < 0.05), no significant change was observed in the placebo group (p > 0.05).","[{'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Önal', 'Affiliation': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey. Electronic address: fztbirolonal@gmail.com.'}, {'ForeName': 'Gülten', 'Initials': 'G', 'LastName': 'Karaca', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Ankara Memorial Hospital, Ankara, Turkey. Electronic address: gulten2013@yahoo.com.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Sertel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Kırıkkale University Faculty of Health Sciences, Kırıkkale, Turkey. Electronic address: fzt_meralaksehir@hotmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105324']
2210,32996689,Effect of dichoptic video game treatment on mild amblyopia - a pilot study.,"PURPOSE


The effect of contrast-balanced dichoptic video game training on distance visual acuity (DVA) and stereo acuity has been investigated in severe-to-moderate amblyopia, but its effect on mild amblyopia and fixation stability has not been assessed. This pilot study aimed to evaluate the effect of home-based dichoptic video game on amblyopic eye DVA, stereo acuity and fixation stability in adults with mild amblyopia.
METHODS


A randomized single-masked design was adopted. The active 6-week home-based treatment was an anaglyphic, contrast-balanced dichoptic video game, and the placebo was an identical non-dichoptic game. Participants (n = 23) had mild amblyopia (amblyopic DVA ≤ 0.28 log Minimum Angle of Resolution (logMAR)). The primary outcome was change in amblyopic DVA at 6 weeks postrandomization. Near visual acuity, stereo acuity and fixation stability (bivariate contour eclipse area) were also measured. Follow-up occurred at 12 and 24 weeks postrandomization.
RESULTS


Mean amblyopic eye DVA was 0.21 ± 0.06 and 0.18 ± 0.06 logMAR for the active (n = 12) and placebo (n = 11) group, respectively. Amblyopic DVA improved significantly more in the active group (0.09 ± 0.05) than in the placebo group (0.03 ± 0.04 logMAR; p < 0.05). The difference between groups remained at 12 weeks postrandomization (p = 0.04) but not at 24 weeks (p = 0.43). Titmus stereo acuities improved significantly more in the active group (0.40 log arcsec) than in the placebo group (0.09 log arcsec) after 6 weeks of gameplay. The between-group difference was still present at 24 weeks postrandomization (p = 0.05). There were no differences between groups on any other secondary outcomes.
CONCLUSION


Home-based dichoptic video gameplay may be an effective method to improve amblyopic DVA and stereo acuity in mild amblyopia.",2020,Titmus stereo acuities improved significantly more in the active group (0.40 log arcsec) than in the placebo group (0.09 log arcsec) after 6 weeks of gameplay.,"['Participants (n\xa0=\xa023) had mild amblyopia (amblyopic DVA\xa0≤\xa00.28 log Minimum Angle of Resolution (logMAR', 'adults with mild amblyopia', 'mild amblyopia ']","['dichoptic video game treatment', 'home-based dichoptic video game', 'placebo', 'contrast-balanced dichoptic video game training']","['distance visual acuity (DVA) and stereo acuity', 'Near visual acuity, stereo acuity and fixation stability (bivariate contour eclipse area', 'change in amblyopic DVA', 'Amblyopic DVA', 'Titmus stereo acuities', 'amblyopic eye DVA, stereo acuity and fixation stability', 'amblyopic DVA and stereo acuity']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C4517445', 'cui_str': '0.28'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]",,0.650303,Titmus stereo acuities improved significantly more in the active group (0.40 log arcsec) than in the placebo group (0.09 log arcsec) after 6 weeks of gameplay.,"[{'ForeName': 'Peter C K', 'Initials': 'PCK', 'LastName': 'Pang', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Carly S Y', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hess', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada.'}]",Acta ophthalmologica,['10.1111/aos.14595']
2211,32996722,Comparative study of motor cortical excitability changes following anodal tDCS or high-frequency tRNS in relation to stimulation duration.,"BACKGROUND


In this study, we investigate the capacity of two different non-invasive brain stimulation (NIBS) techniques (anodal transcranial direct current stimulation (anodal tDCS) and high-frequency transcranial random noise stimulation (hf-tRNS)) regarding the relationship between stimulation duration and their efficacy in inducing long-lasting changes in motor cortical excitability.
METHODS


Fifteen healthy subjects attended six experimental sessions (90 experiments in total) and underwent both anodal tDCS of 7, 13, and 20 min duration, as well as high-frequency 1mA-tRNS of 7, 13, and 20 min stimulation duration. Sessions were performed in a randomized order and subjects were blinded to the applied methods.
RESULTS


For anodal tDCS, no significant stable increases of motor cortical excitability were observed for either stimulation duration. In contrast, for hf -tRNS a stimulation duration of 7 min resulted in a significant increase of motor cortical excitability lasting from 20 to 60 min poststimulation. While an intermediate duration of 13 min hf-tRNS failed to induce lasting changes in motor cortical excitability, a longer stimulation duration of 20 min hf-tRNS led only to significant increases at 50 min poststimulation which did not outlast until 60 min poststimulation.
CONCLUSION


Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy. While hf-tRNS appeared superior to anodal tDCS in this study, further systematic and randomized experiments are necessary to evaluate the generalizability of our observations and to address current intensity as a further modifiable contributor to the variability of transcranial brain stimulation.",2020,"Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy.",['Fifteen healthy subjects attended six experimental sessions (90 experiments in total) and underwent both'],"['invasive brain stimulation (NIBS) techniques (anodal transcranial direct current stimulation (anodal tDCS) and high-frequency transcranial random noise stimulation (hf-tRNS', 'anodal tDCS']","['motor cortical excitability lasting', 'motor cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",15.0,0.0268069,"Hf-tRNS for a duration of 7 min induced robust increases of motor cortical excitability, suggesting an indirect proportional relationship between stimulation duration and efficacy.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Haeckert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lasser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pross', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Munich, München, Germany.'}]",Physiological reports,['10.14814/phy2.14595']
2212,32991582,"The immediate and short-term effects of dynamic taping on pain, endurance, disability, mobility and kinesiophobia in individuals with chronic non-specific low back pain: A randomized controlled trial.","Evidence suggests that the application of Kinesio Tape (KT) on patients with chronic non-specific low back pain (CNLBP) is inconclusive. Dynamic tape (DT) is a relatively new treatment technique, which is increasingly being used as an adjunctive method to treat musculoskeletal problems. To our knowledge, no study has investigated the application of DT in individuals with CNLBP. To compare the immediate and short-term effects of DT versus KT and no tape among patients with CNLBP on pain, endurance, disability, mobility, and kinesiophobia. Forty-five patients with CNLBP were randomly assigned to 1 of 3 groups. Outcomes were measured at baseline, immediately, and on the third day post-application of tapes. The primary outcomes of pain, endurance, and disability were measured through the visual analog scale (VAS), Biering-Sorensen test, and Oswestry disability index (ODI), respectively. Secondary outcome measures of mobility and kinesiophobia were measured using the modified-modified Schober test and the Tampa Scale of Kinesiophobia, respectively. No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia. Improved back extensor endurance was observed for the DT group than KT (p = 0.023) and control group (p = 0.006). The application of DT may result in improvements only in back extensor endurance among individuals with CNLBP. This finding suggests that DT controls the processes that lead to back muscle fatigue.",2020,"No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia.","['patients with CNLBP on', 'Forty-five patients with CNLBP', 'individuals with CNLBP', 'patients with chronic non-specific low back pain (CNLBP', 'individuals with chronic non-specific low back pain']","['Kinesio Tape (KT', 'DT versus KT and no tape', 'dynamic taping', 'Dynamic tape (DT']","['mobility and kinesiophobia', 'Improved back extensor endurance', 'pain, endurance, disability, mobility, and kinesiophobia', 'back extensor endurance', 'pain, endurance, disability, mobility and kinesiophobia', 'DT and KT in pain, disability, mobility, and kinesiophobia', 'pain, endurance, and disability were measured through the visual analog scale (VAS), Biering-Sorensen test, and Oswestry disability index (ODI', 'modified-modified Schober test and the Tampa Scale of Kinesiophobia, respectively']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0491272,"No significant immediate and short-term differences were found between DT and KT in pain, disability, mobility, and kinesiophobia.","[{'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alahmari', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Kanagaraj', 'Initials': 'K', 'LastName': 'Rengaramanujam', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Ravi Shankar', 'Initials': 'RS', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Paul Silvian', 'Initials': 'PS', 'LastName': 'Samuel', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jaya Shanker', 'Initials': 'JS', 'LastName': 'Tedla', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Venkata Nagaraj', 'Initials': 'VN', 'LastName': 'Kakaraparthi', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Kingdom of Saudi Arabia.'}]",PloS one,['10.1371/journal.pone.0239505']
2213,32991589,Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial.,"BACKGROUND


Secondhand smoke can cause adverse pregnancy outcomes, yet there is a lack of effective smoking cessation interventions targeted at expectant fathers. We examined the effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers.
METHODS AND FINDINGS


A single-blind, 3-arm, randomized controlled trial was conducted at the obstetrics registration centers of 3 tertiary public hospitals in 3 major cities (Guangzhou, Shenzhen, and Foshan) in China. Smoking expectant fathers who registered with their pregnant partners were invited to participate in this study. Between 14 August 2017 to 28 February 2018, 1,023 participants were randomized to a video (n = 333), text (n = 322), or control (n = 368) group. The video and text groups received videos or text messages on the risks of smoking for maternal and child health via instant messaging. The control group received a leaflet with information on smoking cessation. Follow-up visits were conducted at 1 week and at 1, 3, and 6 months. The primary outcome, by intention to treat (ITT), was validated abstinence from smoking at the 6-month follow-up. The secondary outcomes included 7-day point prevalence of abstinence (PPA) and level of readiness to quit at each follow-up. The mean age of participants was 32 years, and about half of them were first-time expectant fathers. About two-thirds of participants had completed tertiary education. The response rate was 79.7% (815 of 1,023) at 6 months. The video and text groups had higher rates of validated abstinence than the control group (video group: 22.5% [75 of 333], P < 0.001; text group: 14.9% [48 of 322], P = 0.02; control group: 9.2% [34 of 368]) with adjusted odds ratios (ORs) of 2.80 (95% confidence interval [CI]: 1.79-4.37, P < 0.001) in the video group and 1.70 (95% CI: 1.06-2.74, P = 0.03) in the text group. The video and text groups differed in the rates of validated abstinence (22.5% versus 14.9%, P = 0.008; adjusted OR: 1.64, 95% CI: 1.10-2.46, P = 0.02). The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02). The video and text groups also differed in the rates of 7-day PPA (24.6% versus 17.4%, P = 0.02). Excluding the quitters, the video and text groups had higher levels of readiness to quit than the control group at 6 months (video group: 43.5% [109 of 251] versus 31.6% [103 of 326], P = 0.002; text group: 40.6% [108 of 266] versus 31.6% [103 of 326], P = 0.01), No such difference was detected between the video and text groups (43.5% versus 40.6%, P = 0.29). The study was limited in that the long-term effectiveness of the intervention is uncertain.
CONCLUSIONS


This smoking cessation intervention for expectant fathers that focused on explaining the ramifications of smoking on maternal and child health was effective and feasible in promoting quitting, and video messages were more effective than texts in delivering the information.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03236025.",2020,"The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02).","['Between 14 August 2017 to 28 February 2018, 1,023 participants were randomized to a video (n = 333), text (n = 322), or control (n = 368) group', 'obstetrics registration centers of 3 tertiary public hospitals in 3 major cities (Guangzhou, Shenzhen, and Foshan) in China', 'Smoking expectant fathers who registered with their pregnant partners', 'expectant fathers in China', 'expectant fathers']","['videos or text messages on the risks of smoking for maternal and child health via instant messaging', 'video-based smoking cessation intervention', 'leaflet with information on smoking cessation']","['higher rates of 7-day PPA', 'intention to treat (ITT', 'rates of 7-day PPA', '7-day point prevalence of abstinence (PPA) and level of readiness to quit at each follow-up', 'response rate', 'levels of readiness to quit', 'rates of validated abstinence']","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1023.0,0.124638,"The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wenzhi', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Shenzhen hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Peige', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of gynaecology and obstetrics, Nanhai Hospital Affiliated to Southern Medical University, Foshan, China.'}, {'ForeName': 'Ka Wai Katherine', 'Initials': 'KWK', 'LastName': 'Lam', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Laurie Long Kwan', 'Initials': 'LLK', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ankie Tan', 'Initials': 'AT', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yuanhui', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Clinical Innovation & Research Center (CIRC), Shenzhen Hospital, Southern Medical University, Shenzhen, China.'}, {'ForeName': 'Ka Yan', 'Initials': 'KY', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003355']
2214,32991606,"Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial.","INTRODUCTION


At present, information about clinical efficacy and adverse events of controlled release (CR) form of pelubiprofen, a prodrug of 2-arylopropionic acid with relatively selective effects on cyclooxygenase-2 activity, remains scarce. In this study, we sought to determine non-inferiority of pelubiprofen CR 90 mg/day compared to aceclofenac 200 mg/day regarding clinical efficacy and adverse events after a 4-week course of medication in the patients with symptomatic knee osteoarthritis.
MATERIALS AND METHODS


A total of 191 patients were randomly assigned to take either pelubiprofen CR 90 mg (n = 95) or aceclofenac 200 mg (n = 96). The primary outcome variable was non-inferiority of pain reduction between baseline and week 4 when assessed using a 100 mm pain visual analogue scale (VAS). Pelubiprofen was considered non-inferior to aceclofenac if the upper limit of the one-sided 97.5% confidence interval for the difference in terms of pain VAS was above 15 mm (the average change of pain VAS in the pelubiprofen group-pain VAS reduction in the aceclofenac group). Secondary outcome variables were the changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes at weeks 2 and 4 as compared to baseline, patient global assessment at weeks 2 and 4. The frequency and amount of rescue medicine usage at weeks 2 and 4 were also evaluated as the secondary outcome variable. For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations were assessed and conducted at each follow-up visit.
RESULTS


At week 4, the pain VAS values were significantly reduced in both groups receiving either pelubiprofen CR 90 mg or aceclofenac 200 mg as compared to the baseline. However, the pelubiprofen group and the aceclofenac group respectively showed the pain VAS changes of -22 and -21.9 in the pre-protocol set and -20.8 and -21.7 in the full analysis set, confirming non-inferiority. The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
CONCLUSIONS


Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis.",2020,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","['symptomatic knee osteoarthritis', 'A total of 191 patients', 'patients with symptomatic knee osteoarthritis']","['pelubiprofen CR 90 mg/day compared to aceclofenac', 'Pelubiprofen CR', 'pelubiprofen CR', 'pelubiprofen', 'aceclofenac', 'pelubiprofen CR 90 mg or aceclofenac', 'Pelubiprofen', 'pelubiprofen CR and aceclofenac']","['pain visual analogue scale (VAS', 'frequency and amount of rescue medicine usage', 'pain VAS changes', 'For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations', 'adverse events', 'pain VAS values', 'Efficacy and safety', 'pain VAS', 'non-inferiority of pain reduction', 'changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045712', 'cui_str': 'pelubiprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",191.0,0.155177,"The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005).
","[{'ForeName': 'Joung Youp', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Moon Jong', 'Initials': 'MJ', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Inha University Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kang-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Gon', 'Initials': 'HG', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Dankook University Hospital, Cheonan-si, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Sahnghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Beom', 'Initials': 'SB', 'LastName': 'Han', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Han Jun', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Chung-Ang University, School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Wan', 'Initials': 'YW', 'LastName': 'Moon', 'Affiliation': 'Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University School of Medicine, Ewha Medical Research Center, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238024']
2215,32996842,Randomized Clinical Trial of a Legacy Intervention for Quality of Life in Children with Advanced Cancer.,"Background:  Legacy-making (actions/behaviors aimed at being remembered) may be a significant component for quality of life (QOL) during advanced illness and end of life. Although legacy interventions have been tested in adults, the impact of legacy activities on QOL for children has yet to be clearly defined.  Objective:  This study examined the impact of our newly developed web-based legacy intervention on dimensions of QOL among children (7-17 years old) with advanced cancer.  Design:  This single-site randomized clinical trial (RCT) used a two-group waitlist control design. The legacy intervention guided children to create digital storyboards by directing them to answer legacy questions about themselves (personal characteristics, things they like to do, and connectedness with others) and upload photographs, video, and music.  Setting/Subjects:  Facebook advertisements recruited children (ages 7-17) with relapsed/refractory cancer and their parents from the United States. Child-parent dyads ( N  = 150) were randomized to the intervention or usual care group, and 97 dyads were included for analysis.  Measurements:  Children and parents completed the PedsQL Cancer Module preintervention (T1) and post-intervention (T2).  Results:  Although not statistically significant, legacy-making demonstrated small effects in child procedural anxiety and perceived physical appearance (Cohen's  d  0.35-0.28) compared to the wait-list control group.  Conclusions:  This study contributes important discoveries, including support for the feasibility of a RCT web-based legacy intervention for children with advanced cancer. We did not find convincing evidence supporting the hypothesis that legacy-making improved child dimensions of QOL across time. Overall, this is a null study that warrants discussion on possible reasons for limited findings. Future legacy intervention research is needed using qualitative and quantitative methods, as well as child and parent reports, to determine how such services may improve dimensions of QOL for pediatric palliative care populations. ClinicalTrials.gov number NCT04059393.",2020,"Although not statistically significant, legacy-making demonstrated small effects in child procedural anxiety and perceived physical appearance (Cohen's  d  0.35-0.28) compared to the wait-list control group.  ","['Facebook advertisements recruited children (ages 7-17) with relapsed/refractory cancer and their parents from the United States', 'children (7-17 years old) with advanced cancer', 'Children with Advanced Cancer', 'children with advanced cancer', 'Child-parent dyads ( N \u2009=\u2009150', 'group, and 97 dyads were included for analysis']","['RCT web-based legacy intervention', 'web-based legacy intervention', 'Legacy Intervention', 'intervention or usual care']","['Quality of Life', 'child procedural anxiety and perceived physical appearance', 'PedsQL Cancer Module preintervention (T1) and post-intervention (T2', 'quality of life (QOL']","[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242538', 'cui_str': 'Inheritance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",150.0,0.116442,"Although not statistically significant, legacy-making demonstrated small effects in child procedural anxiety and perceived physical appearance (Cohen's  d  0.35-0.28) compared to the wait-list control group.  ","[{'ForeName': 'Terrah Foster', 'Initials': 'TF', 'LastName': 'Akard', 'Affiliation': 'Vanderbilt University School of Nursing and School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Vanderbilt University Schools of Medicine (Biostatistics, VICC, Psychiatry) and Nursing, Nashville, Tennessee, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Friedman', 'Affiliation': 'Division of Hematology-Oncology, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wray', 'Affiliation': 'Vanderbilt University School of Nursing, Nashville, Tennessee, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Gerhardt', 'Affiliation': ""Department of Pediatrics and Psychology, The Ohio State University and Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.""}, {'ForeName': 'Verna', 'Initials': 'V', 'LastName': 'Hendricks-Ferguson', 'Affiliation': 'Saint Louis University, School of Nursing, St. Louis, Missouri, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': ""Department of Nursing Science, The William and Joanne Conway Chair in Nursing Research, Department of Pediatrics, Children's National Health System and The George Washington University, Washington, DC, USA.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Rhoten', 'Affiliation': 'Department of Nursing, Vanderbilt University School of Nursing, Nashville, Tennessee, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Gilmer', 'Affiliation': 'Nursing and Medicine (Pediatrics), Vanderbilt University School of Nursing and Medicine, Nashville, Tennessee, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0139']
2216,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE


The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS


A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS


The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION


The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
2217,32992190,Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.,"BACKGROUND


The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.
METHODS


This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.
RESULTS


The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
CONCLUSION


This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.",2020,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
",['patients who did not have a primary endpoint within 90 days after enrollment (n\xa0=\xa0397'],"['aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS', 'Dual Antiplatelet Therapy', 'clopidogrel', 'aspirin']","['stroke rate', 'major hemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",397.0,0.0576875,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: abdulara@musc.edu.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States. Electronic address: gcotson@emory.edu.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Holmstedt', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: holmsted@musc.edu.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: mchimow@musc.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105254']
2218,32992206,Impact of a Pre-Discharge Education Session on Stroke Knowledge: a Randomized Trial.,"BACKGROUND AND PURPOSES


Stroke knowledge, awareness of risk factors and stroke warning symptoms is very poor among stroke survivors. We investigated whether a pre-discharge education intervention in the stroke unit could improve stroke knowledge in patients with TIA or minor stroke.
METHODS


We performed a prospective single-center, randomized controlled trial (2013-2016) in patients with TIA or minor stroke. The intervention consisted in an interactive group session focused on stroke education, within the stroke unit before hospital discharge. Primary outcome was the 3-month change in stroke knowledge score (SKS) from randomization. Secondary outcomes were the 12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence.
RESULTS


A total of 199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women) were randomized (99 in stroke education session). Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001). This difference was significantly maintained at 12 months. The number of risk factors and warning signs named were significantly increased in the intervention group at 3 months. Control of risk factors and self-reported adherence did not differ significantly between the two groups.
CONCLUSIONS


An interactive education session in the stroke unit significantly improved stroke knowledge at 3 months and 12 months in patients with TIA or minor stroke.",2020,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","['patients with TIA or minor stroke', '199 patients (mean [SD] age, 63.5 [12.4] years; 67 [33.7%] women']","['Pre-Discharge Education Session', 'pre-discharge education intervention']","['number of risk factors and warning signs named', 'SKS', '3-month change in stroke knowledge score (SKS', 'stroke knowledge', '12-month change in SKS, the number of risk factors and warning signs named, control of risk factors and self-reported adherence', 'Stroke Knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",199.0,0.144626,"Intervention was associated with a greater improvement in SKS than in the control group (baseline-adjusted mean between-group difference, 1.6 point [95%CI, 1.4 to 1.9]; p=0.001).","[{'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Benoit', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France. Electronic address: charline.benoit@aphp.fr.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Loiseau', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Univ.Lille, CHU Lille, EA 2694-Santé Publique:Épidémiologie et Qualité des Soins, F-59000 Lille, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center and Diagnostic and Interventional Neuroradiology, Foch Hospital, University Versailles Saint-Quentin en Yvelines, Suresnes, France.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105272']
2219,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND


Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS


Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS


Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS


A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
2220,32995820,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS CoV-2 in healthcare workers at high-risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18) and for twice weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,"Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
","['healthcare workers at high-risk of exposure', 'healthcare workers', 'Participants across the United States and in the Canadian province of Manitoba', 'healthcare workers with ongoing exposure to persons with Covid-19, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'probable Covid-19-compatible illness', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.742346,"Hydroxychloroquine concentrations did not differ between participants who developed Covid-19 (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
","[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': ''}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': ''}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': ''}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': ''}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': ''}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': ''}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': ''}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': ''}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': ''}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': ''}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': ''}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': ''}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.09.18.20197327']
2221,32994242,Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients.,"INTRODUCTION


As the population ages, there is interest in strategies to promote resiliency, especially for frail patients at risk of its complications. The physiological stress of surgery in high-risk individuals has been proposed both as an important cause of accelerated age-related decline in health and as a model testing the effectiveness of strategies to improve resiliency to age-related health decline. We describe a randomised, embedded, multifactorial, adaptative platform (REMAP) trial to investigate multiple perioperative interventions, the first of which is metformin and selected for its anti-inflammatory and anti-ageing properties beyond its traditional blood glucose control features.
METHODS AND ANALYSIS


Within a multihospital, single healthcare system, the Core Protocol for Strategies to Promote ResiliencY (SPRY) will be embedded within both the electronic health record (EHR) and the healthcare culture generating a continuously self-learning healthcare system. Embedding reduces the administrative burden of a traditional trial while accessing and rapidly analysing routine patient care EHR data. SPRY-Metformin is a placebo-controlled trial and is the first SPRY domain evaluating the effectiveness of three metformin dosages across three preoperative durations within a heterogeneous set of major surgical procedures. The primary outcome is 90-day hospital-free days. Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection. Using response adaptative randomisation, a maximum of 2500 patients allows 77%-92% power, detecting >15% primary outcome improvement. Secondary outcomes include mortality, readmission and postoperative complications. A subset of patients will be selected for substudies evaluating the microbiome, cognition, postoperative delirium and strength.
ETHICS AND DISSEMINATION


The Core Protocol of SPRY REMAP and associated SPRY-Metformin Domain-Specific Appendix have been ethically approved by the Institutional Review Board and are publicly registered. Results will be publicly available to healthcare providers, patients and trial participants following achieving predetermined platform conclusions.
TRIAL REGISTRATION NUMBER


NCT03861767.",2020,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"['frail patients at risk of its complications', 'high-risk patients']","['Metformin', 'SPRY']","['mortality, readmission and postoperative complications', '90-day hospital-free days']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2500.0,0.142159,Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection.,"[{'ForeName': 'Katherine Moll', 'Initials': 'KM', 'LastName': 'Reitz', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA reitzkm2@upmc.edu.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Seymour', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vates', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Quintana', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Morowitz', 'Affiliation': ""Department of Surgery, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Methe', 'Affiliation': 'Department of Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Girard', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Oscar C', 'Initials': 'OC', 'LastName': 'Marroquin', 'Affiliation': 'Clinical Analytics, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Anesthesiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Holder-Murray', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants Statistical Innovation, Austin, Texas, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, UPMC, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037690']
2222,32994304,Two-Level Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty-Long-Term Evidence Update.,"BACKGROUND


Multiple studies have highlighted the motion-sparing benefits of single-level cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF). However, few studies have reviewed multilevel ACDF versus CDA. Several recent studies have midterm and even long-term data available comparing 2-level ACDF versus CDA.
METHODS


We reviewed 3 reports from 2 large randomized, prospective Food and Drug Administration investigational drug exemption trials looking at 2-level CDA versus ACDF, which provide the bulk of the available midterm to long-term, high-level evidence for the topic. We also present several smaller and/or shorter-term studies.
RESULTS


One 5-year study showed that, while both CDA and ACDF showed significant improvement in patient-reported outcome scores, CDA demonstrated greater improvement in Neck Disability Index (NDI) scores than ACDF (mean = -37 versus mean = -28,  P  = .0003), were more likely to be satisfied (96.4% versus 89.5%,  P  = .04), had fewer secondary surgeries (4% versus 16.2%,  P  = .0003), had fewer adjacent level reoperations (3.1% versus 11.4%), and developed less adjacent segment degeneration (50.7% versus 90.5%,  P  < .0001). Adverse events occurred more frequently with ACDF (8.6% versus 4.4%).Similarly, Lanman et al [Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial.  J Neurosurg Spine . 2017;27(1):7-19] showed that, at 7 years, while both groups demonstrated improvement in patient-reported outcomes, CDA had greater improvement in regard to NDI, neck pain, and Short Form (36) Physical Component Summary scores (each  P  < .001), had higher rates of satisfaction (94.8% versus 92.6%), had lower rate of secondary surgery at treated levels (4.2% versus 14.7%), and had a lower, albeit not statistically significant, rate of secondary surgeries at adjacent levels (6.5% versus 12.5%). Adverse events were more common with ACDF (7.2% versus 3.2%).More recently, Gornet et al [Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.  J Neurosurg Spine . 2019;31:508-518.] in 2019 reported 10-year data from the same clinical trial as the Lanman et al report comparing 2-level CDA (209 patients) versus ACDF (188 patients). With >84% follow-up for both groups at 10 years, they found that CDA demonstrated a statistically significantly improved rate of overall success (84% versus 62%) as compared with ACDF. Greater improvements were seen in several other outcome measures for CDA, including NDI, neurological success, and neck pain scores. The CDA group had a lower rate of serious implant-related adverse events and demonstrated a lower rate of needing a secondary surgery at an adjacent level, 9% versus 18% in the ACDF group.
CONCLUSIONS


Results of 2 large randomized trials suggest similar-to-improved patient reported outcomes for multilevel CDA versus ACDF maintained out to midterm to long-term follow-up of 5-10 years, with lower rates of revision surgery at index and adjacent levels and lower rates of serious adverse device-related events.
LEVEL OF EVIDENCE


5.
CLINICAL RELEVANCE


Comparison of the safety and efficacy of multi-level cervical disc arthroplasty and cervical discectomy and fusion.",2020,"Greater improvements were seen in several other outcome measures for CDA, including NDI, neurological success, and neck pain scores.",[],"['anterior cervical discectomy and fusion (ACDF', 'Prestige LP artificial cervical disc replacement', 'Two-Level Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty-Long', 'multi-level cervical disc arthroplasty and cervical discectomy and fusion', 'ACDF', 'Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion']","['rate of needing a secondary surgery', 'Neck Disability Index (NDI) scores', 'regard to NDI, neck pain, and Short Form (36) Physical Component Summary scores', 'Adverse events', 'rates of satisfaction', 'rate of serious implant-related adverse events', 'CDA, including NDI, neurological success, and neck pain scores', 'secondary surgeries', 'adjacent segment degeneration', 'adjacent level reoperations', 'rate of overall success', 'rate of secondary surgeries at adjacent levels']",[],"[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0408598', 'cui_str': 'Excision of cervical intervertebral disc'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C3888829', 'cui_str': 'Adjacent segment degeneration'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.190465,"Greater improvements were seen in several other outcome measures for CDA, including NDI, neurological success, and neck pain scores.","[{'ForeName': 'Zachary H', 'Initials': 'ZH', 'LastName': 'Goldstein', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Barrett', 'Initials': 'B', 'LastName': 'Boody', 'Affiliation': 'Indiana Spine Group, Carmel, Indiana.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Sasso', 'Affiliation': 'Indiana Spine Group, Carmel, Indiana.'}]",International journal of spine surgery,['10.14444/7089']
2223,32993832,Implementing a package of noncommunicable disease interventions in the Republic of Moldova: two-year follow-up data.,"Noncommunicable diseases (NCDs) are a growing challenge in the Republic of Moldova. A previously reported pilot cluster randomized controlled trial aimed to determine the feasibility of implementing and evaluating essential interventions for NCDs (e.g. cardiovascular risk scoring, hypertension management, statin treatment, etc.) in primary health care in the Republic of Moldova, with a view toward national scale up. One-year follow-up data (previously published) demonstrated modest improvements in NCD risk factor identification and management could be achieved. Herein, we report the second-year follow-up data and conclude that sustainable improvements in NCD risk factor control (e.g. hypertension control) can be achieved in primary health care in low resource settings by adapting existing resources (e.g. WHO PEN) and conducting focused clinical training and support. If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",2020,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",[],[],[],[],[],[],,0.0278124,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Inglin', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Ghenadie', 'Initials': 'G', 'LastName': 'Curocichin', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Salaru', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zatic', 'Affiliation': 'Primary, Emergency and Community Health Policies Department, Ministry of Health, Labour and Social Protection, Chisinau, Republic of Moldova.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Anisei', 'Affiliation': 'Department on Quality Management of Health Services, National Public Health Agency, Chisinau, Republic of Moldova.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chiosa', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Munteanu', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Zinaida', 'Initials': 'Z', 'LastName': 'Alexa', 'Affiliation': 'Endocrinology Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",Primary health care research & development,['10.1017/S1463423620000420']
2224,32994594,Combination budesonide/formoterol inhaler as sole reliever therapy in Māori and Pacific people with mild and moderate asthma.,"AIM


In the PRACTICAL study, as-needed budesonide/formoterol reduced the rate of severe exacerbations compared with maintenance budesonide plus as-needed terbutaline. In a pre-specified analysis we analysed the efficacy in Māori and Pacific peoples, populations with worse asthma outcomes.
METHOD


The PRACTICAL study was a 52-week, open-label, parallel group, randomised controlled trial of 890 adults with mild to moderate asthma, who were randomised to budesonide/formoterol Turbuhaler 200/6mcg one actuation as required or budesonide Turbuhaler 200mcg one actuation twice daily and terbutaline Turbuhaler 250mcg two actuations as required. The primary outcome was rate of severe exacerbations. The analysis strategy was to test an ethnicity-treatment interaction term for each outcome variable.
RESULTS


Seventy-two participants (8%) identified as Māori, 36 participants (4%) as Pacific ethnicity. There was no evidence that ethnicity was an effect modifier for severe exacerbations (P interaction 0.70).
CONCLUSION


The reduction in severe exacerbation risk with budesonide-formoterol reliever compared with maintenance budesonide was similar in Māori and Pacific adults compared with New Zealand European/Other.",2020,"There was no evidence that ethnicity was an effect modifier for severe exacerbations (P interaction 0.70).
","['890 adults with mild to moderate asthma', 'Māori and Pacific people with mild and moderate asthma']","['budesonide/formoterol', 'budesonide/formoterol Turbuhaler 200/6mcg one actuation as required or budesonide Turbuhaler 200mcg one actuation twice daily and terbutaline Turbuhaler 250mcg two actuations', 'Combination budesonide/formoterol', 'maintenance budesonide']","['severe exacerbations', 'severe exacerbation risk', 'rate of severe exacerbations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",890.0,0.468676,"There was no evidence that ethnicity was an effect modifier for severe exacerbations (P interaction 0.70).
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Senior Clinical Research Fellow, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Tewhaiti-Smith', 'Affiliation': 'Clinical Research Fellow, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Senior Clinical Research Fellow, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Consultant Physician, Capital and Coast District Health Board, Wellington.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Semprini', 'Affiliation': 'Deputy Director, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Principal Clinical Operations, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Associate Professor, University of Otago, Dunedin.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Professor of Medicine, University of Otago Wellington, Wellington.'}, {'ForeName': 'Matire', 'Initials': 'M', 'LastName': 'Harwood', 'Affiliation': 'Associate Professor, University of Auckland, Auckland.'}]",The New Zealand medical journal,[]
2225,32998624,Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study.,"Background It has been widely recognized that obstructive sleep apnea (OSA) is linked to cardiovascular disease. Yet, randomized controlled studies failed to demonstrate a clear cardiovascular benefit from OSA treatment, mainly because of poor adherence to continuous positive airway pressure (CPAP). To date, no prior study has assessed the effect of CPAP treatment on daytime resting heart rate, a strong predictor of adverse cardiovascular outcomes and mortality. Methods and Results We conducted a randomized controlled study in 39 participants with OSA and prediabetes, who received either in-laboratory all-night (ie, optimal) CPAP or an oral placebo for 2 weeks. During daytime, participants continued daily activities outside the laboratory. Resting heart rate was continuously assessed over 19 consecutive days and nights using an ambulatory device consisting of a single-lead ECG and triaxis accelerometer. Compared with placebo, CPAP reduced daytime resting heart rate (treatment difference, -4.1 beats/min; 95% CI, -6.5 to -1.7 beats/min;  P =0.002). The magnitude of reduction in daytime resting heart rate after treatment significantly correlated with the magnitude of decrease in plasma norepinephrine, a marker of sympathetic activity ( r =0.44;  P =0.02), and the magnitude of decrease in OSA severity (ie, apnea-hypopnea index [ r =0.48;  P =0.005], oxygen desaturation index [ r =0.50;  P =0.003], and microarousal index [ r =0.57;  P <0.001]). Conclusions This proof-of-concept randomized controlled study demonstrates, for the first time, that CPAP treatment, when optimally used at night, reduces resting heart rate during the day, and therefore has positive cardiovascular carry over effects. These findings suggest that better identification and treatment of OSA may have important clinical implications for cardiovascular disease prevention. Registration URL: https:/// www.clini​caltr​ials.gov; Unique identifier: NCT01156116.",2020,"Compared with placebo, CPAP reduced daytime resting heart rate (treatment difference, -4.1 beats/min; 95% CI, -6.5 to -1.7 beats/min;  P =0.002).","['Prediabetes', '39 participants with OSA and prediabetes, who received either in-laboratory all-night (ie, optimal) CPAP or an oral placebo for 2\xa0weeks']","['CPAP', 'placebo, CPAP', 'OSA']","['Resting heart rate', 'daytime resting heart rate', 'resting heart rate', 'oxygen desaturation index', 'plasma norepinephrine, a marker of sympathetic activity', 'OSA severity (ie, apnea-hypopnea index']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",39.0,0.0828933,"Compared with placebo, CPAP reduced daytime resting heart rate (treatment difference, -4.1 beats/min; 95% CI, -6.5 to -1.7 beats/min;  P =0.002).","[{'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Pamidi', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit Centre for Outcomes Research and Evaluation McGill University and Research Institute of the McGill University Health Centre Montreal Quebec Canada.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Chapotot', 'Affiliation': 'PhiTools Strasbourg France.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wroblewski', 'Affiliation': 'Department of Public Health Sciences University of Chicago IL.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Whitmore', 'Affiliation': 'Department of Medicine University of Chicago IL.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine University of Chicago IL.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Tasali', 'Affiliation': 'Department of Medicine University of Chicago IL.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016871']
2226,32994159,"Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories:  Post Hoc  Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial.","BACKGROUND AND OBJECTIVES


In the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome), empagliflozin, in addition to standard of care, significantly reduced risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and incident or worsening nephropathy by 39% compared with placebo in patients with type 2 diabetes and established cardiovascular disease. Using EMPA-REG Outcome data, we assessed whether the Kidney Disease Improving Global Outcomes (KDIGO) CKD classification had an influence on the treatment effect of empagliflozin.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Patients with type 2 diabetes, established atherosclerotic cardiovascular disease, and eGFR≥30 ml/min per 1.73 m 2  at screening were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care.  Post hoc , we analyzed cardiovascular and kidney outcomes, and safety, using the two-dimensional KDIGO classification framework.
RESULTS


Of 6952 patients with baseline eGFR and urinary albumin-creatinine ratio values, 47%, 29%, 15%, and 8% were classified into low, moderately increased, high, and very high KDIGO risk categories, respectively. Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60). In all KDIGO risk categories, placebo and empagliflozin had similar adverse event rates, the notable exception being genital infection events, which were more common with empagliflozin for each category.
CONCLUSIONS


The observed effects of empagliflozin versus placebo on cardiovascular and kidney outcomes were consistent across the KDIGO risk categories, indicating that the effect of treatment benefit of empagliflozin was unaffected by baseline CKD status.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


EMPA-REG OUTCOME, NCT01131676.",2020,Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60).,"['Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome', 'Patients with type 2 diabetes, established atherosclerotic cardiovascular disease, and eGFR≥30 ml/min per 1.73 m 2  at screening', '6952 patients with']","['empagliflozin', 'placebo and empagliflozin', 'empagliflozin 10 mg, empagliflozin 25 mg, or placebo', 'placebo', 'Empagliflozin', 'Placebo']","['adverse event rates', 'Kidney Disease Improving Global Outcomes (KDIGO', 'risk of cardiovascular death', 'cardiovascular and kidney outcomes, and safety', 'hospitalization for heart failure', 'baseline eGFR and urinary albumin-creatinine ratio values', 'kidney outcomes', 'cardiovascular and kidney outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6952.0,0.578353,Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes ( P  values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes ( P  values for treatment by subgroup interactions ranged from 0.16 to 0.60).,"[{'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, Canada alevin@providencehealth.bc.ca.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.14901219']
2227,32994178,Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children.,"BACKGROUND AND OBJECTIVES


Postpyloric feeding tube placement is a time-consuming procedure associated with multiple attempts and radiation exposure. Our objective with this study is to compare the time, attempts, and radiation exposure using the electromagnetic versus blind method to place a postpyloric feeding tube in critically ill children. Our hypothesis is that using electromagnetic guidance decreases the procedure time, number of x-rays, and number of attempts, compared to the blind method.
METHODS


Eleven pediatric nurses participated in a randomized controlled intention-to-treat study at an academic pediatric medical, surgical, and congenital cardiac ICU. University of Texas Health Epidemiology and Biostatistics generated a randomization sequence with sealed envelopes. A standard (2-sided) F-test of association between the electromagnetic and blind method yielded 40 subjects with 86% power. Data were analyzed with Fisher's exact test for categorical variables and the Wilcoxon rank test for continuous variables, with data documented as median (interquartile range [IQR]).
RESULTS


We randomly assigned 52 patients to either the electromagnetic ( n  = 28) or blind method ( n  = 24). The number of attempts and radiographs was at a median of 2 (IQR: 1-2.25) using the blind method, compared to the electromagnetic method at a median of 1 (IQR: 1.0-1.0;  P  = .001). Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008). The total time required was 2.5 minutes (IQR: 2.0-7.25) with the electromagnetic method, compared to 19 minutes (IQR: 9.25-27.0) for the blind method ( P  = .001).
CONCLUSIONS


Electromagnetic guidance is a superior, faster, and overall safer method to place a postpyloric feeding tube in critically ill children.",2020,"Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008).","['critically ill children', 'Eleven pediatric nurses participated in a randomized controlled intention-to-treat study at an academic pediatric medical, surgical, and congenital cardiac ICU', 'Critically Ill Children', '40 subjects with 86% power']","['Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube', 'Electromagnetic guidance', 'electromagnetic']","['number of attempts and radiographs', 'procedure time, number of x-rays, and number of attempts', 'total time required']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",52.0,0.0772211,"Successful guidance was 96.4% with the electromagnetic method, compared to only 66.7% with the blind technique ( P  = .008).","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Jha', 'Affiliation': ""Division of Critical Care, Department of Pediatrics, Children's Hospital of Nevada at University Medical Center, Las Vegas, Nevada; prashant.jha@umcsn.com.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rupp', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bonilla', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gelfond', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Texas Health San Antonio, San Antonio, Texas.'}, {'ForeName': 'Jay N', 'Initials': 'JN', 'LastName': 'Shah', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Meyer', 'Affiliation': 'Pediatric Services, University Health System, San Antonio, Texas; and.'}]",Pediatrics,['10.1542/peds.2019-3773']
2228,32997575,Five-Year Outcomes With Nivolumab in Patients With Wild-Type  BRAF  Advanced Melanoma.,"PURPOSE


The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated  BRAF  wild-type advanced melanoma. Five-year results are presented herein.
PATIENTS AND METHODS


In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type  BRAF  melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m 2  every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.
RESULTS


Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n = 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report.
CONCLUSION


Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.",2020,"Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.","['418 patients with previously untreated, unresectable, stage III/IV, wild-type  BRAF  melanoma', 'patients with previously untreated  BRAF  wild-type advanced melanoma', 'Patients With Wild-Type  BRAF  Advanced Melanoma']","['nivolumab monotherapy', 'nivolumab 3 mg/kg every 2 weeks or dacarbazine', 'Nivolumab', 'dacarbazine']","['PFS rates', 'ORR', 'Survival', 'complete response', 'overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety', 'Five-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}]",418.0,0.559944,"Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brady', 'Affiliation': 'Cabrini Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint André Centre Hospitalier Universitaire, Bordeaux, France.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'University of Lille, INSERM U1189, Service de Dermatologie, Chu Lille, Lille, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse, Melanoma Institute Australia, and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Ewa Anna', 'Initials': 'EA', 'LastName': 'Kalinka', 'Affiliation': ""Polish Mother's Memorial Hospital-Research Institute, Lodz, Poland.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'Grenoble Alpes University Hospital, INSERM U1209, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Micaela M', 'Initials': 'MM', 'LastName': 'Hernberg', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'British Columbia Cancer Agency, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Mihalcioiu', 'Affiliation': 'Royal Victoria Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'University Hospital Cologne and Centrum für Integrierte Onkologie Köln, Bonn, Germany.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clínic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Regina Elena Institute, Rome, Italy.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ny', 'Affiliation': 'Department of Oncology, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, Comprehensive Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Zoco', 'Affiliation': ""Syneos Health, Braine l'Alleud, Belgium.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Re', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, and Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, Queensland, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00995']
2229,33002463,Central Sleep Apnea and Pacing-Induced Cardiomyopathy.,"The role of central sleep apnea (CSA) in pacing-induced cardiomyopathy (PICM) remains speculative. In a prospective trial entitled UPGRADE, the presence of CSA was assessed by single-night polysomnography (PSG) in 54 PICM patients within 1 month after left ventricular lead implantation (with biventricular stimulation still not activated). CSA was diagnosed in half of patients (n = 27). Patients with moderate or severe CSA were randomized to cardiac resynchronization therapy (CRT) versus right ventricular pacing (RVP) in a double-blinded cross-over design and re-scheduled for a follow-up PSG within 3 to 5 months. After crossing-over of stimulation mode another PSG was conducted 3 to 5 months later. CRT led to a significant increase in left ventricular ejection fraction and significant reduction in left ventricular end systolic volumes and N-terminal pro brain natriuretic peptide plasma levels, whereas no significant effects were observed with ongoing RVP. CSA was significantly improved after 3.9 (3.2 to 4.4) months of CRT: apnea-hypopnea index decreased from 39.1 (32.1 to 54.0) events per hour at baseline to 22.2/h (10.9 to 36.7) by CRT (p <0.001). Central apnea index decreased from 27.1/h (17.7 to 36.1) at baseline to 6.8/h (1.1 to 14.4) after CRT activation (p <0.001). Ongoing RVP yielded only a minor improvement in apnea-hypopnea index and central apnea index. Pre-existent CSA did not affect structural response rate and had no impact on mid-term follow-up (median 2.8 years). In conclusion, CSA is highly prevalent in patients with PICM. CRT upgrading significantly improves CSA leading to a similar outcome in PICM patients without pre-existent CSA.",2020,"CRT led to a significant increase in left ventricular ejection fraction and significant reduction in left ventricular end systolic volumes and N-terminal pro brain natriuretic peptide plasma levels, whereas no significant effects were observed with ongoing RVP.","['patients with PICM', '54 PICM patients within one month after left ventricular lead implantation (with biventricular stimulation still not activated', 'Patients with moderate or severe CSA']","['CRT', 'CSA', 'single-night polysomnography (PSG', 'cardiac resynchronisation therapy (CRT) versus right ventricular pacing (RVP', 'central sleep apnea (CSA']","['Central Sleep Apnea and Pacing-Induced Cardiomyopathy', 'CSA', 'left ventricular end systolic volumes and N-terminal pro brain natriuretic peptide plasma levels', 'CRT: apnea hypopnea index (AHI', 'Central apnea index', 'structural response rate', 'AHI and central apnea index', 'left ventricular ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3532227', 'cui_str': 'Pacing-induced cardiomyopathy'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C3532227', 'cui_str': 'Pacing-induced cardiomyopathy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",54.0,0.0356165,"CRT led to a significant increase in left ventricular ejection fraction and significant reduction in left ventricular end systolic volumes and N-terminal pro brain natriuretic peptide plasma levels, whereas no significant effects were observed with ongoing RVP.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Barbieri', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Agne', 'Initials': 'A', 'LastName': 'Adukauskaite', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heidbreder', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Brandauer', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Senoner', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubatscher', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Schgör', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stühlinger', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Bernhard Erich', 'Initials': 'BE', 'LastName': 'Pfeifer', 'Affiliation': 'Institute of Clinical Epidemiology, Tirol Kliniken, Innsbruck, Austria; Institute of Medical Informatics, UMIT TIROL, Eduart Wallnöfer Zentrum, Hall in Tirol, Austria.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bauer', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Hintringer', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Sleep Disorders Clinic, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Dichtl', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria. Electronic address: dichtl@me.com.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.09.027']
2230,32997684,A Short Message Service (SMS) increases postpartum care-seeking behavior and uptake of family planning of mothers in peri-urban public facilities in Kenya.,"BACKGROUND


It is estimated that one third of maternal deaths in Kenya in 2014 could have been prevented by more timely care-seeking. Mobile health interventions are increasingly being recognized as tools for the delivery of health education and promotion. Many maternal deaths occur in the first few weeks after delivery and mothers who are given adequate care in the postpartum period have better health outcomes. Kiambu County, Kenya has a high level of literacy and phone ownership amongst mothers delivering in public hospitals and was chosen as a site for a postpartum short message service intervention.
METHODS


Women were recruited after delivery and randomized to receive a package of mobile messages or standard of care only. Messages covered danger signs, general postpartum topics, and family planning. Endline phone surveys were conducted at 8 weeks postpartum to assess knowledge, care seeking behavior and family planning uptake. Analysis was conducted using Stata and is presented in odds ratios.
RESULTS


Women who received the danger sign messages were 1.6 times more likely to be able to list at least 1 danger sign and 3.51 times more likely to seek treatment if they experienced postpartum danger signs. There was no significant difference in routine postpartum care seeking or care seeking behaviors concerning newborns. Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
CONCLUSIONS


Simple, low-cost mobile interventions can support women in the early postpartum period when the information is targeted to particular points in the postpartum continuum. Additional research is needed to understand the interplay between healthcare providers and mobile health interventions. Health policy makers should consider direct mobile interventions for women as an option for supporting positive maternal health outcomes in certain populations.",2020,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","['Women', 'mothers in peri-urban public facilities in Kenya']","['package of mobile messages or standard of care only', 'Short Message Service (SMS']","['uptake family planning services', 'routine postpartum care seeking or care seeking behaviors concerning newborns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034018', 'cui_str': 'Public facilities'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",,0.0717481,"Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a long-acting method.
","[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kimenju', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Subbiah', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Styles', 'Affiliation': 'Independent Researcher, Nairobi, Kenya.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Sathyanath', 'Initials': 'S', 'LastName': 'Rajasekharan', 'Affiliation': 'Department of Research & Design, Jacaranda Health, Nairobi, Kenya.'}]",PloS one,['10.1371/journal.pone.0239213']
2231,33002436,"Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial.","BACKGROUND


HER2-positive metastatic breast cancer is incurable and new treatments are needed. Addition of atezolizumab to trastuzumab emtansine might potentiate anticancer immunity and enhance the HER2-targeted cytotoxic activity of trastuzumab emtansine. We aimed to test this combination in HER2-positive advanced breast cancer that had progressed after previous treatment with trastuzumab and a taxane.
METHODS


The KATE2 study is a randomised, double-blind, placebo-controlled, phase 2 study at 68 centres from nine countries across Asia, Australia, North America, and western Europe. Eligible patients were adults (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and centrally confirmed, measurable, HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane. Patients were randomly assigned (2:1) either trastuzumab emtansine (3·6 mg/kg of bodyweight) plus atezolizumab (1200 mg) or trastuzumab emtansine plus placebo; all study drugs were administered by intravenous infusion every 3 weeks. Randomisation was done via an interactive voice and web response system using a permuted block scheme (block size of six) and was stratified by PD-L1 status, world region, and liver metastases. Patients, investigators, and study team members were masked to treatment allocation. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02924883, and the study has been completed.
FINDINGS


Between Sept 26, 2016, and Aug 7, 2017, 330 patients were screened for the study, of whom 202 were randomly allocated either atezolizumab (n=133) or placebo (n=69). At the recommendation of the independent data monitoring committee, treatment assignment was unmasked on Dec 11, 2017, due to futility and the numerically higher frequency of adverse events among patients assigned atezolizumab. This date was set as the clinical cutoff for the primary analysis. Median follow-up was 8·5 months (IQR 6·1-11·5) for patients assigned atezolizumab and 8·4 months (5·3-11·1) for those assigned placebo. Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23; p=0·33). The most common grade 3 or worse adverse events were thrombocytopenia (17 [13%] among 132 patients who received atezolizumab vs three [4%] among 68 who received placebo), increased aspartate aminotransferase (11 [8%] vs two [3%]), anaemia (seven [5%] vs 0), neutropenia (six [5%] vs three [4%]), and increased alanine aminotransferase (six [5%] vs two [3%]). Serious adverse events occurred in 43 (33%) of 132 patients who received atezolizumab and 13 (19%) of 68 patients who received placebo. One patient who received atezolizumab died due to a treatment-related adverse event (haemophagocytic syndrome).
INTERPRETATION


Addition of atezolizumab to trastuzumab emtansine did not show a clinically meaningful improvement in progression-free survival and was associated with more adverse events. Further study of trastuzumab emtansine plus atezolizumab is warranted in a subpopulation of patients with PD-L1-positive, HER2-positive advanced breast cancer.
FUNDING


F Hoffman-La Roche.",2020,"Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23;","['Eligible patients were adults (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and centrally confirmed, measurable, HER2-positive advanced breast cancer previously treated with', 'HER2-positive advanced breast cancer that had progressed after previous treatment with', 'patients with PD-L1-positive, HER2-positive advanced breast cancer', 'Between Sept 26, 2016, and Aug 7, 2017, 330 patients were screened for the study, of whom 202', 'previously treated, HER2-positive advanced breast cancer (KATE2', '68 centres from nine countries across Asia, Australia, North America, and western Europe']","['trastuzumab and a taxane', 'trastuzumab emtansine (3·6 mg/kg of bodyweight) plus atezolizumab', 'Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo', 'trastuzumab emtansine plus placebo', 'placebo', 'trastuzumab emtansine plus atezolizumab', 'atezolizumab']","['thrombocytopenia', 'aspartate aminotransferase', 'Serious adverse events', 'alanine aminotransferase', 'investigator-assessed progression-free survival', 'neutropenia', 'anaemia', 'progression-free survival', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0043129', 'cui_str': 'West European country'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",330.0,0.76858,"Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23;","[{'ForeName': 'Leisha A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address: emensla@upmc.edu.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Perlmutter Cancer Center at New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Beresford', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Roche (China) Holding, Shanghai, China.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salgado', 'Affiliation': 'Department of Pathology, Gasthuis Zusters Antwerpen-Ziekenhuis Netwerk Antwerpen Hospitals, Antwerp, Belgium.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Mani', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jigna', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lambertini', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Sanne L', 'Initials': 'SL', 'LastName': 'de Haas', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Patre', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research, Peter MacCallum Cancer Center, Melbourne, VIC, Australia. Electronic address: sherene.loi@petermac.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30465-4']
2232,33002437,"Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial.","BACKGROUND


Adjuvant radiotherapy has been shown to halve the risk of biochemical progression for patients with high-risk disease after radical prostatectomy. Early salvage radiotherapy could result in similar biochemical control with lower treatment toxicity. We aimed to compare biochemical progression between patients given adjuvant radiotherapy and those given salvage radiotherapy.
METHODS


We did a phase 3, randomised, controlled, non-inferiority trial across 32 oncology centres in Australia and New Zealand. Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less. Patients were randomly assigned (1:1) using a minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more. Allocation sequence was concealed from investigators and patients, but treatment assignment for individual randomisations was not masked. Patients were stratified by radiotherapy centre, preoperative PSA, Gleason score, surgical margin status, and seminal vesicle invasion status. Radiotherapy in both groups was 64 Gy in 32 fractions to the prostate bed without androgen deprivation therapy with real-time review of plan quality on all cases before treatment. The primary endpoint was freedom from biochemical progression. Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48. The primary analysis was done on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, NCT00860652.
FINDINGS


Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to adjuvant radiotherapy; 167 to salvage radiotherapy). Median follow-up was 6·1 years (IQR 4·3-7·5). An independent data monitoring committee recommended premature closure of enrolment because of unexpectedly low event rates. 84 (50%) patients in the salvage radiotherapy group had radiotherapy triggered by a PSA of 0·20 ng/mL or more. 5-year freedom from biochemical progression was 86% (95% CI 81-92) in the adjuvant radiotherapy group versus 87% (82-93) in the salvage radiotherapy group (stratified HR 1·12, 95% CI 0·65-1·90; p non-inferiority =0·15). The grade 2 or worse genitourinary toxicity rate was lower in the salvage radiotherapy group (90 [54%] of 167) than in the adjuvant radiotherapy group (116 [70%] of 166). The grade 2 or worse gastrointestinal toxicity rate was similar between the salvage radiotherapy group (16 [10%]) and the adjuvant radiotherapy group (24 [14%]).
INTERPRETATION


Salvage radiotherapy did not meet trial specified criteria for non-inferiority. However, these data support the use of salvage radiotherapy as it results in similar biochemical control to adjuvant radiotherapy, spares around half of men from pelvic radiation, and is associated with significantly lower genitourinary toxicity.
FUNDING


New Zealand Health Research Council, Australian National Health Medical Research Council, Cancer Council Victoria, Cancer Council NSW, Auckland Hospital Charitable Trust, Trans-Tasman Radiation Oncology Group Seed Funding, Cancer Research Trust New Zealand, Royal Australian and New Zealand College of Radiologists, Cancer Institute NSW, Prostate Cancer Foundation Australia, and Cancer Australia.",2020,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"['32 oncology centres in Australia and New Zealand', 'patients with high-risk disease after radical prostatectomy', 'patients given', 'Between March 27, 2009, and Dec 31, 2015, 333 patients were randomly assigned (166 to', 'Eligible patients were aged at least 18 years and had undergone a radical prostatectomy for adenocarcinoma of the prostate with pathological staging showing high-risk features defined as positive surgical margins, extraprostatic extension, or seminal vesicle invasion; had an Eastern Cooperative Oncology Group performance status of 0-1, and had a postoperative prostate-specific antigen (PSA) concentration of 0·10 ng/mL or less']","['Adjuvant radiotherapy versus early salvage radiotherapy', 'Salvage radiotherapy', 'adjuvant radiotherapy', 'minimisation technique via an internet-based, independently generated allocation to either adjuvant radiotherapy within 6 months of radical prostatectomy or early salvage radiotherapy triggered by a PSA of 0·20 ng/mL or more', 'adjuvant radiotherapy; 167 to salvage radiotherapy', 'adjuvant radiotherapy and those given salvage radiotherapy', 'Radiotherapy', 'radical prostatectomy (TROG 08.03/ANZUP RAVES', 'salvage radiotherapy', 'radiotherapy']","['grade 2 or worse gastrointestinal toxicity rate', 'freedom from biochemical progression', 'grade 2 or worse genitourinary toxicity rate']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",333.0,0.349874,Salvage radiotherapy would be deemed non-inferior to adjuvant radiotherapy if freedom from biochemical progression at 5 years was within 10% of that for adjuvant radiotherapy with a hazard ratio (HR) for salvage radiotherapy versus adjuvant radiotherapy of 1·48.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kneebone', 'Affiliation': 'Department of Radiation Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: andrew.kneebone@health.nsw.gov.au.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Fraser-Browne', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Duchesne', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Cabrini Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'University of Melbourne, Melbourne, VIC, Australia; Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Warick', 'Initials': 'W', 'LastName': 'Delprado', 'Affiliation': 'Douglass Hanly Moir Pathology, Sydney, NSW, Australia; University of Notre Dame Australia, Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'University of Western Australia, Perth, WA, Australia; Edith Cowan University, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia; 5D Clinics, Perth, WA, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Calvary Mater Newcastle Hospital, Newcastle, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'John H L', 'Initials': 'JHL', 'LastName': 'Matthews', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Millar', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; Alfred Health Radiation Oncology, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sidhom', 'Affiliation': 'Cancer Therapy Centre, Liverpool Hospital, Sydney, NSW, Australia; University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia; Genesis Cancer Care, Perth, WA, Australia.'}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Tang', 'Affiliation': 'Edith Cowan University, Perth, WA, Australia; Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Crown Princess Mary Cancer Centre, Westmead, NSW, Australia.'}, {'ForeName': 'Kirsty L', 'Initials': 'KL', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Urology, Sydney Adventist Hospital, Wahroonga, NSW Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Monash University, Melbourne, VIC, Australia; ANZUP Cancer Trials Group, Sydney, NSW, Australia; Eastern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Tee S', 'Initials': 'TS', 'LastName': 'Lim', 'Affiliation': 'Genesis Cancer Care, Perth, WA, Australia; Curtin Medical School, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pearse', 'Affiliation': 'Auckland Hospital, Auckland, New Zealand.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30456-3']
2233,33002438,"Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial.","BACKGROUND


Adjuvant radiotherapy reduces the risk of biochemical progression in prostate cancer patients after radical prostatectomy. We aimed to compare adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy, in terms of oncological outcomes and tolerance.
METHODS


GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals. Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study. Eligible patients were randomly assigned (1:1) to either immediate adjuvant radiotherapy or delayed salvage radiotherapy at the time of biochemical relapse. Random assignment, by minimisation, was done using web-based software and stratified by Gleason score, pT stage, and centre. All patients received 6 months of triptorelin (intramuscular injection every 3 months). The primary endpoint was event-free survival. Efficacy and safety analyses were done on the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT00667069.
FINDINGS


Between March 7, 2008, and June 23, 2016, 424 patients were enrolled. We planned to enrol 718 patients, with 359 in each study group. However, on May 20, 2016, the independent data monitoring committee recommended early termination of enrolment because of unexpectedly low event rates. At database lock on Dec 19, 2019, the overall median follow-up time from random assignment was 75 months (IQR 50-100), 74 months (47-100) in the adjuvant radiotherapy group and 78 months (52-101) in the salvage radiotherapy group. In the salvage radiotherapy group, 115 (54%) of 212 patients initiated study treatment after biochemical relapse. 205 (97%) of 212 patients started treatment in the adjuvant group. 5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42). Acute grade 3 or worse toxic effects occurred in six (3%) of 212 patients in the adjuvant radiotherapy group and in four (2%) of 212 patients in the salvage radiotherapy group. Late grade 2 or worse genitourinary toxicities were reported in 125 (59%) of 212 patients in the adjuvant radiotherapy group and 46 (22%) of 212 patients in the salvage radiotherapy group. Late genitourinary adverse events of grade 2 or worse were reported in 58 (27%) of 212 patients in the adjuvant radiotherapy group versus 14 (7%) of 212 patients in the salvage radiotherapy group (p<0·0001). Late erectile dysfunction was grade 2 or worse in 60 (28%) of 212 in the adjuvant radiotherapy group and 17 (8%) of 212 in the salvage radiotherapy group (p<0·0001).
INTERPRETATION


Although our analysis lacked statistical power, we found no benefit for event-free survival in patients assigned to adjuvant radiotherapy compared with patients assigned to salvage radiotherapy. Adjuvant radiotherapy increased the risk of genitourinary toxicity and erectile dysfunction. A policy of early salvage radiotherapy could spare men from overtreatment with radiotherapy and the associated adverse events.
FUNDING


French Health Ministry and Ipsen.",2020,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","['Eligible patients', 'prostate cancer patients after radical prostatectomy', 'men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17', 'Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study', 'GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals', '718 patients, with 359 in each study group', 'Between March 7, 2008, and June 23, 2016, 424 patients were enrolled']","['salvage radiotherapy plus short-term androgen deprivation therapy', 'adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy', 'adjuvant radiotherapy', 'Adjuvant radiotherapy', 'triptorelin', 'salvage radiotherapy', 'radiotherapy', 'immediate adjuvant radiotherapy or delayed salvage radiotherapy']","['5-year event-free survival', 'Late erectile dysfunction', 'risk of genitourinary toxicity and erectile dysfunction', 'Late grade 2 or worse genitourinary toxicities', 'Acute grade 3 or worse toxic effects', 'Late genitourinary adverse events', 'event-free survival', 'Efficacy and safety analyses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",424.0,0.16146,"5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Institut Bergonié, Bordeaux, France. Electronic address: p.sargos@bordeaux.unicancer.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chabaud', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magné', 'Affiliation': 'Institut de Cancérologie de la Loire, Saint-Priest-en-Jarèz, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Benyoucef', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': ""Institut de Cancérologie de l'Ouest, Site René Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pasquier', 'Affiliation': 'Centre Oscar Lambret and Lille University, Lille, France.'}, {'ForeName': 'Menouar Samir', 'Initials': 'MS', 'LastName': 'Abdiche', 'Affiliation': 'Centre Hospitalier Robert Boulin, Libourne, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gilliot', 'Affiliation': 'Clinique Marzet, Pau, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff-Cailleaud', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Centre François Baclesse, Caen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bergerot', 'Affiliation': ""Clinique Mutualiste de l'Estuaire, Cité Sanitaire, Saint-Nazaire, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Baumann', 'Affiliation': ""Centre d'Oncologie de Gentilly, Nancy, France.""}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacemi', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris Est Créteil, Creteil, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Azria', 'Affiliation': ""Institut Régional du Cancer de Montpellier Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Brihoum', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Soulié', 'Affiliation': 'CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Richaud', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30454-X']
2234,33004382,Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee): protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Up to 20% of patients undergoing total knee replacement (TKR) surgery report no or suboptimal pain relief after TKR. Moreover, despite chances of recovering to preoperative functional levels, patients receiving TKR have demonstrated persistent deficits in quadriceps strength and functional performance compared with healthy age-matched adults. We intend to examine if low-load blood flow restricted exercise (BFRE) is an effective preoperative method to increase functional capacity, lower limb muscle strength and self-reported outcomes after TKR. In addition, the study aims to investigate to which extent preoperative BFRE will protect against surgery-related atrophy 3 months after TKR.
METHODS


In this multicentre, randomised controlled and assessor blinded trial, 84 patients scheduled for TKR will be randomised to receive usual care and 8 weeks of preoperative BFRE or to follow usual care-only. Data will be collected before randomisation, 3-4 days prior to TKR, 6 weeks, 3 months and 12 months after TKR. Primary outcome will be the change in 30 s chair stand test from baseline to 3-month follow-up. Key secondary outcomes will be timed up and go, 40 me fast-paced walk test, isometric knee extensor and flexor strength, patient-reported outcome and selected myofiber properties.Intention-to-treat principle and per-protocol analyses will be conducted. A one-way analysis of variance model will be used to analyse between group mean changes. Preintervention-to-postintervention comparisons will be analysed using a mixed linear model. Also, paired Student's t-test will be performed to gain insight into the potential pretraining-to-post-training differences within the respective training or control groups and regression analysis will be used for analysation of associations between selected outcomes.
ETHICAL APPROVAL


The trial has been accepted by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 10-72-19-19) and the Danish Data Protection Agency (Journal No 652164). All results will be published in international peer-reviewed scientific journals regardless of positive, negative or inconclusive results.
TRIAL REGISTRATION NUMBER


NCT04081493.",2020,"Moreover, despite chances of recovering to preoperative functional levels, patients receiving TKR have demonstrated persistent deficits in quadriceps strength and functional performance compared with healthy age-matched adults.","['patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee', '84 patients scheduled for TKR']","['total knee replacement (TKR) surgery report no or suboptimal pain relief after TKR', 'low-load blood flow restricted resistance EXercise', 'low-load blood flow restricted exercise (BFRE', 'usual care and 8\u2009weeks of preoperative BFRE or to follow usual care-only']","['quadriceps strength and functional performance', 'change in 30\u2009s chair stand test', 'timed up and go, 40 me fast-paced walk test, isometric knee extensor and flexor strength, patient-reported outcome and selected myofiber properties']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",84.0,0.112106,"Moreover, despite chances of recovering to preoperative functional levels, patients receiving TKR have demonstrated persistent deficits in quadriceps strength and functional performance compared with healthy age-matched adults.","[{'ForeName': 'Stian Langgård', 'Initials': 'SL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Occupantional and Physical Therapy, Horsens Regional Hospital, Horsens, Denmark stiajo@rm.dk.'}, {'ForeName': 'Marie Bagger', 'Initials': 'MB', 'LastName': 'Bohn', 'Affiliation': 'Department of Orthopedic Surgery, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034376']
2235,33004383,Pragmatic evaluation of a coproduced physical activity referral scheme: a UK quasi-experimental study.,"OBJECTIVES


UK exercise referral schemes (ERSs) have been criticised for focusing too much on exercise prescription and not enough on sustainable physical activity (PA) behaviour change. Previously, a theoretically grounded intervention (coproduced PA referral scheme, Co-PARS) was coproduced to support long-term PA behaviour change in individuals with health conditions. The purpose of this study was to investigate the effectiveness of Co-PARS compared with a usual care ERS and no treatment for increasing cardiorespiratory fitness.
DESIGN


A three-arm quasi-experimental trial.
SETTING


Two leisure centres providing (1) Co-PARS, (2) usual exercise referral care and one no-treatment control.
PARTICIPANTS


68 adults with lifestyle-related health conditions (eg, cardiovascular, diabetes, depression) were recruited to co-PARS, usual care or no treatment.
INTERVENTION


16-weeks of PA behaviour change support delivered at 4, 8, 12 and 18 weeks, in addition to the usual care 12-week leisure centre access.
OUTCOME MEASURES


Cardiorespiratory fitness, vascular health, PA and mental well-being were measured at baseline, 12 weeks and 6 months (PA and mental well-being only). Fitness centre engagement (co-PARS and usual care) and behaviour change consultation attendance (co-PARS) were assessed. Following an intention-to-treat approach, repeated-measures linear mixed models were used to explore intervention effects.
RESULTS


Significant improvements in cardiorespiratory fitness ( p =0.002) and vascular health ( p =0.002) were found in co-PARS compared with usual care and no-treatment at 12 weeks. No significant changes in PA or well-being at 12 weeks or 6 months were noted. Intervention engagement was higher in co-PARS than usual care, though this was not statistically significant.
CONCLUSION


A coproduced PA behaviour change intervention led to promising improvements in cardiorespiratory and vascular health at 12 weeks, despite no effect for PA levels at 12 weeks or 6 months.
TRIAL REGISTRATION NUMBER


NCT03490747.",2020,"A coproduced PA behaviour change intervention led to promising improvements in cardiorespiratory and vascular health at 12 weeks, despite no effect for PA levels at 12 weeks or 6 months.
","['individuals with health conditions', '68 adults with lifestyle-related health conditions (eg, cardiovascular, diabetes, depression) were recruited to co-PARS, usual care or no treatment', 'Two leisure centres providing (1']","['Co-PARS', 'Co-PARS, (2) usual exercise referral care and one no-treatment control']","['Cardiorespiratory fitness, vascular health, PA and mental well-being', 'cardiorespiratory fitness', 'PA levels', 'Fitness centre engagement (co-PARS and usual care) and behaviour change consultation attendance (co-PARS', 'vascular health', 'cardiorespiratory and vascular health']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557790', 'cui_str': 'Leisure center'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",68.0,0.0452586,"A coproduced PA behaviour change intervention led to promising improvements in cardiorespiratory and vascular health at 12 weeks, despite no effect for PA levels at 12 weeks or 6 months.
","[{'ForeName': 'Benjamin Jr', 'Initials': 'BJ', 'LastName': 'Buckley', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK Benjamin.Buckley@Liverpool.ac.uk.'}, {'ForeName': 'Dick Hj', 'Initials': 'DH', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Murphy', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Lee Ef', 'Initials': 'LE', 'LastName': 'Graves', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cochrane', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Gillison', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Crone', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, Brock University, Saint Catharines, Ontario, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Whyte', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Watson', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034580']
2236,33004384,Developing a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice and subsequently change antibiotic use.,"OBJECTIVES


To develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result.
METHODS


Theory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention 'guiding principles' and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials.
RESULTS


The collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers.
CONCLUSIONS


We present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.",2020,Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change.,"['patients attending PAT', 'support clinicians and patients to amend incorrect penicillin allergy records in general practice']","['penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin', 'behavioural intervention package']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030824', 'cui_str': 'Allergy to penicillin'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0030824', 'cui_str': 'Allergy to penicillin'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",[],,0.0327525,Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santillo', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK marta.santillo@phc.ox.ac.uk.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Wanat', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Savic', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, Leeds, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Savic', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Healthcare Associated Infection Group, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Fielding', 'Affiliation': 'Healthcare Associated Infection Group, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Pavitt', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sandoe', 'Affiliation': 'Healthcare Associated Infection Group, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tonkin-Crine', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035793']
2237,33004392,Randomised multicentre clinical trial to evaluate voriconazole pre-emptive genotyping strategy in patients with risk of aspergillosis: vorigenipharm study protocol.,"INTRODUCTION


Invasive aspergillosis is the most important cause of morbidity and mortality in patients with haematological diseases. At present, voriconazole is the first-line treatment for invasive fungal disease. The pharmacokinetic interindividual variability of voriconazole depends on genetic factors. CYP450 is involved in 70%-75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%-30% of metabolism conducted by monooxygenase flavins. CYP2C19 single nucleotide polymorphisms could explain 50%-55% of variability in voriconazole metabolism.
MATERIALS AND METHODS


The main objective is to compare efficiency of pre-emptive voriconazole genotyping with routine practice. The primary outcome is serum voriconazole on the fifth day within the therapeutic range. The secondary outcome is the combined variables of therapeutic failure and adverse events within 90 days of first administration, associated with voriconazole. A total of 146 patients at risk of invasive aspergillosis who will potentially receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient ultimately receives voriconazole, they will be randomised (1:1 experimental/control). In the experimental arm, patients will receive a dose according to a pharmacogenetic algorithm, including CYP2C19 genotype and clinical and demographic information. In the control arm, patients will receive a dose according to clinical practice guidelines. In addition, a Spanish National Healthcare System (NHS) point-of-view cost-effectiveness evaluation will be performed. Direct cost calculations for each arm will be performed.
CONCLUSION


This trial will provide information about the viability and cost-effectiveness of the implementation of a pre-emptive voriconazole genotyping strategy in the Spanish NHS.
ETHICS AND DISSEMINATION


A Spanish version of this protocol has been evaluated and approved by the La Paz University Hospital Ethics Committee and the Spanish Agency of Medicines and Medical Devices. Trial results will be submitted for publication in an open peer-reviewed medical speciality-specific publication.
TRIAL REGISTRATION NUMBER


Eudra-CT: 2019-000376-41 and NCT04238884; Pre-results.",2020,"CYP450 is involved in 70%-75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%-30% of metabolism conducted by monooxygenase flavins.","['patients with haematological diseases', 'patients with risk of aspergillosis', '146 patients at risk of invasive aspergillosis who will potentially receive voriconazole will be recruited, and CYP2C19 will be genotyped']","['Eudra-CT', 'voriconazole', 'voriconazole pre-emptive genotyping strategy']","['therapeutic failure and adverse events', 'serum voriconazole on the fifth day within the therapeutic range']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004030', 'cui_str': 'Aspergillosis'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0238013', 'cui_str': 'Invasive aspergillosis'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}]",146.0,0.0965944,"CYP450 is involved in 70%-75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%-30% of metabolism conducted by monooxygenase flavins.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Monserrat Villatoro', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García García', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bueno', 'Affiliation': 'Pediatric Oncology and Haematology Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Cámara', 'Affiliation': 'Haematology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Estébanez', 'Affiliation': 'Internal Medicine Department, Hospital Central de la Defensa Gómez Ulla, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'López de la Guía', 'Affiliation': 'Haematology Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Antón', 'Affiliation': 'Health Technology Assessment Department, Universidad Francisco de Vitoria, Pozuelo de Alarcon, Madrid, Spain.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mejía', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Otero', 'Affiliation': 'Haematology Department, Hospital Central de la Defensa Gómez Ulla, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ramírez García', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Frías Iniesta', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carcas', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Borobia', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario La Paz IdiPAZ, Madrid, Spain alberto.borobia@salud.madrid.org.'}]",BMJ open,['10.1136/bmjopen-2020-037443']
2238,33006562,An Interactive Text Messaging Intervention to Improve Adherence to Option B+ Prevention of Mother-to-Child HIV Transmission in Kenya: Cost Analysis.,"BACKGROUND


Mobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care.
OBJECTIVE


The aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial.
METHODS


The Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017.
RESULTS


The weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively).
CONCLUSIONS


Cost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions.",2020,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"['Mother-to-Child HIV Transmission in Kenya', 'peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV']","['interactive semiautomated SMS text messaging intervention', 'Interactive Text Messaging Intervention', 'interactive SMS text messaging support intervention']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C2936492', 'cui_str': 'Peripartum Women'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0560755,The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups.,"[{'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matemo', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18351']
2239,33006564,User Experiences of a Smartphone-Based Attentive Eating App and Their Association With Diet and Weight Loss Outcomes: Thematic and Exploratory Analyses From a Randomized Controlled Trial.,"BACKGROUND


Short-term laboratory studies suggest that eating attentively can reduce food intake. However, in a recent randomized controlled trial we found no evidence that using an attentive eating smartphone app outside of the laboratory had an effect on energy intake or weight loss over 8 weeks.
OBJECTIVE


This research examined trial participants' experiences of using an attentive eating smartphone app and whether app usage was associated with energy intake and weight loss outcomes over 8 weeks.
METHODS


We conducted thematic analysis of semistructured interviews (N=38) among participants in the attentive eating smartphone app group of the trial who completed the 8-week assessment. Linear regression models examined the associations between energy intake and weight loss outcomes at 8 weeks and app usage.
RESULTS


Participants reported several barriers and facilitators to using the smartphone app, including repetition of app content, social setting, motivation, and habitual use of the app. Participants believed that using the app had some beneficial effects on their eating behavior and diet. Exploratory analyses indicated that more frequent recording of eating episodes in the app was associated with lower body weight (B=-0.02, P=.004) and greater self-reported energy intake (B=5.98, P=.01) at 8 weeks, but not body fat percentage or taste-test energy intake. Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
CONCLUSIONS


Frequent recording of eating episodes in a smartphone app was associated with greater weight loss. There are barriers and facilitators to frequent use of an attentive eating smartphone app that may be useful to address when designing dietary behavior change smartphone apps.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03602001; https://clinicaltrials.gov/ct2/show/NCT03602001; Open Science Framework DOI 10.17605/osf.io/btzhw; https://osf.io/btzhw/.",2020,"Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
",['semistructured interviews (N=38) among participants in the attentive eating smartphone app group of the trial who completed the 8-week assessment'],['Smartphone-Based Attentive Eating App and Their Association With Diet and Weight'],"['energy intake or weight loss', 'weight loss', 'Total audio clip plays, gallery views, and percentage of food entries', 'lower body weight', 'greater self-reported energy intake', 'repetition of app content, social setting, motivation, and habitual use of the app', 'frequent recording of eating episodes']","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.127886,"Total audio clip plays, gallery views, and percentage of food entries recorded using an image were not significantly associated with energy intake or weight.
","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whitelock', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Kersbergen', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higgs', 'Affiliation': 'The School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Services, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jason Cg', 'Initials': 'JC', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/16780']
2240,33006567,Predictors and Effects of Usage of an Online Mindfulness Intervention for Distressed Cancer Patients: Usability Study.,"BACKGROUND


One in three cancer patients experience high psychological distress. Mindfulness-based interventions are effective in reducing psychological distress in this patient group. However, these interventions lack availability and flexibility, which may compromise participation in the intervention for cancer patients experiencing late symptoms like fatigue or pain. Therefore, mindfulness-based interventions are increasingly offered via the internet. However, little is known about the usage of these online mindfulness-based interventions.
OBJECTIVE


The aim of this study was to (1) predict uptake of and adherence to online mindfulness-based cognitive therapy (eMBCT) using baseline patient characteristics (demographic, cancer-related, personality, and psychological variables) and (2) examine the relations between adherence and treatment outcomes in eMBCT for cancer patients.
METHODS


A total of 125 cancer patients were assigned to eMBCT in a parent randomized controlled trial comparing MBCT and eMBCT with treatment as usual in distressed cancer patients. Various usage measures of eMBCT were automatically tracked within the online program. Based on activity of use, participants were classified as nonusers, minimal users, low users, and intended users. Questionnaires were used to assess baseline characteristics (preintervention) and outcomes (pre- and postintervention). To answer the research questions, data were analyzed with t tests, χ 2  tests, and linear regression models.
RESULTS


Based on weekly activity, participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions. Nonusers had more fear of cancer recurrence at baseline than users (uptake), and intended users were more conscientious than minimal and low users (adherence). Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
CONCLUSIONS


This study showed that adherence was related to improved patient outcomes. Patients with strong fear of recurrence or low levels of conscientiousness should receive extra attention, as they are less likely to respectively start or complete eMBCT. Future research may focus on the development of flexible and adaptive eMBCT programs to fit individual needs.",2020,"Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
","['distressed cancer patients', 'Patients with strong fear of recurrence or low levels of conscientiousness', '125 cancer patients', 'cancer patients experiencing late symptoms like fatigue or pain', 'cancer patients', 'Distressed Cancer Patients', 'participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions', 'participants were classified as nonusers, minimal users, low users, and intended users', 'three cancer patients experience high psychological distress']","['online mindfulness-based cognitive therapy (eMBCT', 'eMBCT', 'Mindfulness-based interventions', 'Online Mindfulness Intervention', 'MBCT and eMBCT']","['psychological distress', 'fear of cancer recurrence', 'positive mental health (ie, emotional, psychological, and social well-being']","[{'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",125.0,0.0800104,"Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Monique Om', 'Initials': 'MO', 'LastName': 'van de Ven', 'Affiliation': 'Department of Medical Psychology, Laurentius Hospital, Roermond, Netherlands.'}, {'ForeName': 'Félix R', 'Initials': 'FR', 'LastName': 'Compen', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Else M', 'Initials': 'EM', 'LastName': 'Bisseling', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Marije L', 'Initials': 'ML', 'LastName': 'van der Lee', 'Affiliation': 'Scientific Research Department, Centre for Psycho-Oncology, Helen Dowling Institute, Bilthoven, Netherlands.'}, {'ForeName': 'Anne Em', 'Initials': 'AE', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Center for Mindfulness, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/17526']
2241,33006569,Evaluating the Efficacy of a Mobile App (Drinks:Ration) and Personalized Text and Push Messaging to Reduce Alcohol Consumption in a Veteran Population: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Alcohol misuse is higher in the UK Armed Forces than in the general population. Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
OBJECTIVE


This single-blinded randomized controlled trial (RCT) aims to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and receive or have received support for mental health symptoms in a clinical setting.
METHODS


In this two-arm, single-blinded RCT, a smartphone app that includes interactive features designed to enhance participants' motivation and personalized messaging is compared with a smartphone app that provides only government guidance on alcohol consumption. The trial will be conducted in a veteran population that has sought help through Combat Stress, a UK veteran's mental health charity. Recruitment, consent, and data collection will be carried out automatically through the Drinks:Ration platform. The primary outcome is the change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption. Secondary outcome measures include (1) change in the baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score and (2) change in the baseline to 3-month follow-up (day 84) World Health Organization Quality of Life-BREF score to assess the quality of adjusted life years. Process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be reassessed at the 6-month follow-up (day 168) to assess the longer-term benefits of the intervention, which will be reported as a secondary outcome.
RESULTS


The study will begin recruitment in October 2020 and is expected to require 12 months to complete. The study results will be published in 2022.
CONCLUSIONS


This study assesses whether a smartphone app is efficacious in reducing self-reported alcohol consumption in a veteran population that has sought help through Combat Stress using personalized messaging and interactive features. This innovative approach, if successful, may provide a means to deliver a low-cost health promotion program that has the potential to reach large groups, in particular those who are geographically dispersed, such as military personnel.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04494594; https://clinicaltrials.gov/ct2/show/NCT04494594.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19720.",2020,"Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
",['veterans who drink at a hazardous or harmful level and receive or have received support for mental health symptoms in a clinical setting'],"['alcohol intervention delivered via a smartphone app (Drinks:Ration', 'Mobile App (Drinks:Ration) and Personalized Text and Push Messaging', 'smartphone']","['change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption', 'Process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire', 'World Health Organization Quality of Life-BREF score', '1) change in the baseline to 3-month follow-up (day 84']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451543', 'cui_str': 'Time line follow back'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.170033,"Previous research has shown that interventions delivered via smartphones are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption, and have a broad reach.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Leightley', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'Roberto J', 'Initials': 'RJ', 'LastName': 'Rona', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shearer', 'Affiliation': ""King's College London, King's Health Economics, London, United Kingdom.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Williamson', 'Affiliation': 'Combat Stress, Leatherhead, United Kingdom.'}, {'ForeName': 'Cerisse', 'Initials': 'C', 'LastName': 'Gunasinghe', 'Affiliation': ""King's College London, Department of Psychological Medicine, London, United Kingdom.""}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Simms', 'Affiliation': ""Academic Department of Military Mental Health, King's College London, London, United Kingdom.""}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Fear', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goodwin', 'Affiliation': 'University of Liverpool, Department of Psychological Sciences, Liverpool, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': ""King's College London, King's Centre for Military Health Research, London, United Kingdom.""}]",JMIR research protocols,['10.2196/19720']
2242,33008559,Postural Changes and the Trans-Lamina Cribrosa Pressure Difference: A Pilot Study in Neurosurgical Patients without Glaucoma.,"PURPOSE


To evaluate the effect of changes in position in the trans-lamina cribrosa pressure difference (TLCPD) by simultaneously measuring and comparing intracranial pressure (ICP) with intraocular pressure (IOP) in seated and supine positions.
DESIGN


Prospective cohort study.
PARTICIPANTS


Patients admitted to the neurosurgery unit at Toronto Western Hospital with an external ventricular drain placed for ICP monitoring. Exclusion criteria were any ophthalmic surgical procedures within the preceding 6 months, history of glaucoma, and corneal abnormalities affecting IOP measurement.
METHODS


Intraocular pressure and ICP were recorded simultaneously in both the supine and seated positions with the order of positions randomized. Measurements were made 10 minutes after assuming each position. The TLCPD (IOP minus ICP) was calculated for the sitting and supine positions. The paired t test was used to assess significance of differences.
MAIN OUTCOME MEASURE


The TLCPD.
RESULTS


Twenty patients were included in the study. The average age was 54±17 years. Results were similar for left and right eyes. Data are shown for right eyes only. Mean sitting and supine IOPs were 15.3±3.5 mmHg and 15.9±3.7 mmHg, respectively (P = 0.32). Mean sitting and supine ICPs were 12.5±6.8 mmHg and 12.8±5.1 mmHg, respectively (P = 0.66). Mean TLCPD was 3.1±6.0 mmHg in the sitting position and 3.1±7.0 mmHg in the supine position (P = 1.00). Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
CONCLUSIONS


In this pilot study of 20 neurosurgical patients without glaucoma, posture-induced TLCPD changes were variable.",2020,"Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
","['20 neurosurgical patients without glaucoma, posture-induced TLCPD changes were variable', 'Patients admitted to the neurosurgery unit at Toronto Western Hospital with an external ventricular drain placed for ICP monitoring', 'Neurosurgical Patients without Glaucoma', 'Twenty patients were included in the study']",['simultaneously measuring and comparing intracranial pressure (ICP) with intraocular pressure (IOP'],"['Mean sitting and supine IOPs', 'TLCPD (IOP minus ICP', 'Mean sitting and supine ICPs', 'Mean TLCPD', 'Postural Changes and the Trans-Lamina Cribrosa Pressure Difference', 'Supine TLCPD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0150260', 'cui_str': 'Intracranial pressure monitoring regime'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.033462,"Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
","[{'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Belkin', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada. Electronic address: avner.belkin@gmail.com.'}, {'ForeName': 'Rana A', 'Initials': 'RA', 'LastName': 'Greene', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Trope', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Jin', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gentili', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Buys', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.02.007']
2243,32997907,Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.,"BACKGROUND


The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) with PD-L1 expression are not known.
METHODS


We conducted a randomized, open-label, phase 3 trial involving patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay. Patients were assigned in a 1:1 ratio to receive atezolizumab or chemotherapy. Overall survival (primary end point) was tested hierarchically according to PD-L1 expression status among patients in the intention-to-treat population whose tumors were wild-type with respect to  EGFR  mutations or  ALK  translocations. Within the population with  EGFR  and  ALK  wild-type tumors, overall survival and progression-free survival were also prospectively assessed in subgroups defined according to findings on two PD-L1 assays as well as by blood-based tumor mutational burden.
RESULTS


Overall, 572 patients were enrolled. In the subgroup of patients with  EGFR  and  ALK  wild-type tumors who had the highest expression of PD-L1 (205 patients), the median overall survival was longer by 7.1 months in the atezolizumab group than in the chemotherapy group (20.2 months vs. 13.1 months; hazard ratio for death, 0.59; P = 0.01). Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups. Overall and progression-free survival favored atezolizumab in the subgroups with a high blood-based tumor mutational burden.
CONCLUSIONS


Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. (Funded by F. Hoffmann-La Roche/Genentech; IMpower110 ClinicalTrials.gov number, NCT02409342.).",2020,"Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups.","['572 patients were enrolled', 'PD-L1-Selected Patients with NSCLC', 'patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay', 'patients with NSCLC with high PD-L1 expression, regardless of histologic type', 'patients with metastatic non-small-cell lung cancer (NSCLC']","['atezolizumab', 'atezolizumab or chemotherapy', 'platinum-based chemotherapy', 'Atezolizumab']","['Overall survival', 'overall survival and progression-free survival', 'adverse events', 'safety, adverse events', 'median overall survival', 'Overall and progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449574', 'cui_str': 'Histologic type'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",572.0,0.10554,"Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups.","[{'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giaccone', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Morise', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Andric', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Sarayut', 'Initials': 'S', 'LastName': 'Geater', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Enquist', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Komatsubara', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kuriki', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McCleland', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Mocci', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': ""From the Yale School of Medicine, New Haven, CT (R.S.H.); Weill Cornell Medical Center, New York (G.G.); the European Institute of Oncology, IRCCS, Milan (F.M.); Asklepios Lung Clinic, Munich-Gauting, Germany (N.R.); University Hospital Limoges, Limoges, France (A.V.); Centro de Pesquisa Clínica, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (C.H.B.); Nagoya University Graduate School of Medicine, Aichi, Japan (M. Morise); Vall d'Hebron University Hospital, Barcelona (E.F.); Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia (Z.A.); Prince of Songkla University-Hat Yai, Songkhla, Thailand (S.G.); Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey (M.O.); Genentech, South San Francisco, CA (W.Z., A.S., I.E., K.K., Y.D., H.K., X.W., M. McCleland, S.M.); the Medical University of Gdańsk, Gdansk, Poland (J.J.); and the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.R.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1917346']
2244,33003132,Which Device Is Favorable for Intubation Attempts of Pediatric Residents on Four Different Pediatric Airway Simulations?,"OBJECTIVES


Endotracheal intubation is an essential skill for the pediatric airway management. Although direct laryngoscopy (DL) is the standard method, several videolaryngoscopes (VLs) have been recently enhanced as an alternative especially for difficult intubations. We aimed to compare McGrath MAC (McG) and Storz C-MAC PM (ST) VLs with DL in terms of intubation success rate, time to intubation (TTI), and duration of obtaining glottis view of intubation attempts performed by pediatric residents on different pediatric airway manikins.
METHODS


The pediatric residents with no experience in videolaryngoscopy were included. After a brief demonstration, intubation attempts with 3 randomly handled different devices with 6 different blades were performed on a child manikin, an infant manikin, a Pierre-Robin sequence infant manikin, and a child manikin with cervical immobilization sequentially.
RESULTS


Fifty pediatric residents were enrolled. The attempts of DL on child manikin and attempts of all devices on child with cervical immobilization simulation were completely successful. For the attempts on both infant manikin and Pierre-Robin sequence infant manikin, the success rate of McG was significantly lower than ST and DL (P = 0.011 and P = 0.001). In the child manikin, McG and ST had prolonged TTI compared with DL (P = 0.016 and P = 0.001). For the child with cervical immobilization simulation, TTI of DL was significantly shorter than McG and ST (P = 0.011 and P = 0.001). Time to intubation of McG was significantly longer than DL and ST for the attempts on both 2 infant manikins. The rate of Cormack-Lehane grade I glottis view was similar for the attempts on both 2 child airway simulations. For infant manikin and Pierre-Robin sequence infant simulation, the rate of Cormack-Lehane grade I of ST was higher than attempts of DL and McG.
CONCLUSIONS


The attempts of pediatric residents on infant normal airway and Pierre-Robin sequence infant airway simulations resulted with enhanced glottis view by the utilization of Storz C-MAC PM, but both 2 VLs did not provide the improvement of intubation success rate and TTI compared with DL on these 4 different pediatric manikins. Further clinical studies of different VLs in different clinical courses are required for a reliable utilization in children.",2020,"In the child manikin, McG and ST had prolonged TTI compared with DL (P = 0.016 and P = 0.001).","['Fifty pediatric residents were enrolled', 'pediatric residents on different pediatric airway manikins', 'pediatric residents with no experience in videolaryngoscopy were included', 'children']","['Endotracheal intubation', 'McGrath MAC (McG) and Storz C-MAC PM (ST) VLs with DL', 'child manikin, an infant manikin, a Pierre-Robin sequence infant manikin, and a child manikin with cervical immobilization sequentially', 'direct laryngoscopy (DL']","['Time to intubation of McG', 'intubation success rate, time to intubation (TTI), and duration of obtaining glottis view of intubation attempts', 'success rate of McG', 'rate of Cormack-Lehane grade I glottis view']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031900', 'cui_str': 'Robin sequence'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]",50.0,0.0270644,"In the child manikin, McG and ST had prolonged TTI compared with DL (P = 0.016 and P = 0.001).","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Er', 'Affiliation': 'From the *Division of Pediatric Emergency Medicine, Department of Pediatrics †Department of Pediatrics, Dokuz Eylul University, School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Çağlar', 'Affiliation': ''}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Çitlenbik', 'Affiliation': ''}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Akgül', 'Affiliation': ''}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Ulusoy', 'Affiliation': ''}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Ören', 'Affiliation': ''}, {'ForeName': 'Durgül', 'Initials': 'D', 'LastName': 'Yιlmaz', 'Affiliation': ''}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Duman', 'Affiliation': ''}]",Pediatric emergency care,['10.1097/PEC.0000000000002247']
2245,33004398,Feasibility study of eye movement desensitisation and reprocessing (EMDR) in people with an at-risk mental state (ARMS) for psychosis: study protocol.,"INTRODUCTION


Trauma can play an important role in the development of psychosis, yet no studies have investigated whether a trauma-focused psychological therapy could prevent the onset of psychosis in people at high risk of developing this condition. This study aims to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy to prevent the onset of psychosis in people with an at-risk mental state (ARMS).
METHODS/ANALYSIS


This is a single-arm trial with a nested qualitative study where all participants (target n=20) will be offered EMDR. Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD). Participants will be followed up at 4, 8 and 12 months after the baseline assessment. The primary outcome measure is transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use. The analysis will aim to establish the rates of recruitment and retention for a large-scale RCT. Interviews with therapists and patients will explore their views of the study and their experiences of delivering or receiving EMDR.
ETHICS AND DISSEMINATION


This protocol has been approved by the South West-Cornwall and Plymouth Research Ethics Committee (Reference 18/SW/0037). Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners.
TRIAL REGISTRATION NUMBER


ISRCTN31976295.",2020,"Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners.
","['Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD', 'people with an at-risk mental state (ARMS) for psychosis', 'people with an at-risk mental state (ARMS']","['eye movement desensitisation and reprocessing (EMDR) therapy', 'eye movement desensitisation and reprocessing (EMDR']","['transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.387837,"Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners.
","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Strelchuk', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK daniela.strelchuk@bristol.ac.uk.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Turner', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Derrick', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Zammit', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038620']
2246,18105766,A drug treatment trial in pleuro-pulmonary tuberculosis.,,1948,,['pleuro-pulmonary tuberculosis'],[],[],"[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}]",[],[],,0.0937534,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'DE COURTEN', 'Affiliation': ''}]",Therapeutische Umschau. Revue therapeutique,[]
2247,18124671,The Cens trial and judicial narcoanalysis.,,1949,,[],[],[],[],[],[],,0.0200147,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'VORMSER', 'Affiliation': ''}]",Le Medecin generaliste de France,[]
2248,15393368,"Conjunctivitis, blepro-conjunctivitis and melbomian blepharitis; therapeutic trial by diathermo-coagulation of the mebomian orifices.",,1949,,[],[],[],[],[],[],,0.0225988,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'COUZI', 'Affiliation': ''}]",Annales d'oculistique,[]
2249,15393615,"Diasone leprosy treatment trial; 5 months, ten observations.",,1949,,[],[],[],[],[],[],,0.0163794,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'BRYGOO', 'Affiliation': ''}]",Medecine tropicale : revue du Corps de sante colonial,[]
2250,18098455,Intervention of beta-carotene during the oxidation of lipid media in the dark and in the light.,,1948,,[],['beta-carotene'],[],[],"[{'cui': 'C0053396', 'cui_str': 'Beta Carotene'}]",[],,0.0146017,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'CHEVALLIER', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'BURG', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'MANUEL', 'Affiliation': ''}]",Comptes rendus des seances de la Societe de biologie et de ses filiales,[]
2251,18100226,Allantoin gastric dressing trial.,,1948,,[],[],[],[],[],[],,0.0392599,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'BOLTANSKI', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'RYMER', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'ETIENNE', 'Affiliation': ''}]",Archives des maladies de l'appareil digestif et des maladies de la nutrition,[]
2252,33006952,Modulation of sleep using electrical vestibular nerve stimulation prior to sleep onset: a pilot study.,"Objectives Electrical stimulation of the vestibular system (VeNS) has been shown to improve Insomnia Severity Index (ISI) when delivered during sleep. We hypothesize that repeated electrical vestibular stimulation, when delivered prior to sleep onset, will improve ISI scores. The primary aim of this study was to assess the effect that VeNS had on ISI scores when delivered prior to sleep onset. A secondary aim was to provide initial data indicating ""length of time to effect"" that will allow more appropriate design of a larger randomized control trial (RCT). Methods The present study was an experimental study (pre and post without control). The participants acted as self-controls. After recording the baseline values, electrical vestibular nerve stimulation was administered as intervention once in a day for 30 min, 1 h prior to sleep onset using ML1000 device (Neurovalens, UK) for 14 days. Results There was significant decrease in the ISI scores followed by the electrical vestibular nerve stimulation. Further, participants reported a significant increase in well-rested sleep post the intervention period. Conclusions This study supports our hypothesis that VeNS has a positive impact on ISI scores when delivered on a regular basis prior to sleep onset.",2020,There was significant decrease in the ISI scores followed by the electrical vestibular nerve stimulation.,[],"['vestibular system (VeNS', 'VeNS', 'electrical vestibular nerve stimulation']","['Insomnia Severity Index (ISI', 'ISI scores', 'well-rested sleep']",[],"[{'cui': 'C0682674', 'cui_str': 'Structure of vestibular system'}, {'cui': 'C0042469', 'cui_str': 'Venezuela'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0042598', 'cui_str': 'Vestibular nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0447025,There was significant decrease in the ISI scores followed by the electrical vestibular nerve stimulation.,"[{'ForeName': 'Sai Sailesh Kumar', 'Initials': 'SSK', 'LastName': 'Goothy', 'Affiliation': 'Department of Physiology, R.D Gardi Medical College, Ujjain, Madhya Pradesh, India.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McKeown', 'Affiliation': 'Center for Brain and Cognition, UC San Diego, San Diego, USA.'}]",Journal of basic and clinical physiology and pharmacology,['10.1515/jbcpp-2020-0019']
2253,33006966,"Disapproval from romantic partners, friends and parents: Source of criticism regulates prefrontal cortex activity.","The prevalence of criticism in everyday social situations, and its empirically demonstrated association with psychopathology, highlight the importance of understanding neural mechanisms underlying the perception and response of individuals to criticism. However, neuroimaging studies to date have been limited largely to maternal criticism. The present study aims to investigate neural responses to observing criticism occurring in the context of three different relationship types: romantic partners, friends, and parents-from a third-party perspective. 49 participants were recruited and asked to rate the perceived criticism for these relationships. Functional near-infrared spectroscopy was used to measure changes in oxygenated haemoglobin levels in the prefrontal cortex when participants read vignettes describing three different scenarios of criticism. Participants were randomly assigned to 3 groups where the given description of the relationship of the protagonist to the source of criticism for each vignette was randomised. A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex. Compared to low perceived criticism, high perceived criticism individuals showed increased activation reading vignettes describing criticism from romantic partners and parents but decreased activation for those from friends. Findings contribute to understanding neural responses to criticism as observed from a third-party perspective. Future studies can look into differentiating neural responses of personalised experiences of criticism and third-party observations.",2020,A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex.,"['49 participants', 'Disapproval from romantic partners, friends and parents']",[],"['oxygenated haemoglobin levels', 'criticism ratings']","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",[],"[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",49.0,0.0291149,A significant interaction between relationship type and perceived criticism ratings for mothers was found in the dorsolateral prefrontal cortex.,"[{'ForeName': 'Michelle Jin-Yee', 'Initials': 'MJ', 'LastName': 'Neoh', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Atiqah', 'Initials': 'A', 'LastName': 'Azhari', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mulatti', 'Affiliation': 'Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy.'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Bornstein', 'Affiliation': 'Child and Family Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, Untied States of America.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0229316']
2254,33006980,Pre-operative aerobic exercise on metabolic health and surgical outcomes in patients receiving bariatric surgery: A pilot trial.,"OBJECTIVE


Examine if adding aerobic exercise to standard medical care (EX+SC) prior to bariatric surgery improves metabolic health in relation to surgical outcomes.
METHODS


Fourteen bariatric patients (age: 42.3±2.5y, BMI: 45.1±2.5 kg/m2) met inclusion criteria and were match-paired to pre-operative SC (n = 7) or EX+SC (n = 7; walking 30min/d, 5d/wk, 65-85% HRpeak) for 30d. A 120min mixed meal tolerance test was performed pre- and post-intervention (~2d prior to surgery) to assess insulin sensitivity (Matsuda Index) and metabolic flexibility (indirect calorimetry). Aerobic fitness (VO2peak), body composition (BodPod), and adipokines (adiponectin, leptin) were also measured. Omental adipose tissue was collected during surgery to quantify gene expression of adiponectin and leptin, and operating time and length of hospital stay were recorded. ANOVA and Cohen's d effect size (ES) was used to test group differences.
RESULTS


SC tended to increase percent body fat (P = 0.06) after the intervention compared to EX+SC. Although SC and EX+SC tended to raise insulin sensitivity (P = 0.11), EX+SC enhanced metabolic flexibility (P = 0.01, ES = 1.55), reduced total adiponectin (P = 0.01, ES = 1.54) with no change in HMW adiponectin and decreased the length of hospital stay (P = 0.05) compared to SC. Albeit not statistically significant, EX+SC increased VO2peak 2.9% compared to a 5.9% decrease with SC (P = 0.24, ES = 0.91). This increased fitness correlated to shorter operating time (r = -0.57, P = 0.03) and length of stay (r = -0.58, P = 0.03). Less omental total adiponectin (r = 0.52, P = 0.09) and leptin (r = 0.58, P = 0.05) expression correlated with shorter operating time, and low leptin expression was linked to shorter length of stay (r = 0.70, P = 0.01), and low leptin expression was linked to shorter length of stay (r = 0.70, P = 0.01).
CONCLUSION


Adding pre-operative aerobic exercise to standard care may improve surgical outcomes through a fitness and adipose tissue derived mechanism.",2020,"RESULTS


SC tended to increase percent body fat (P = 0.06) after the intervention compared to EX+SC.","['Fourteen bariatric patients (age: 42.3±2.5y, BMI: 45.1±2.5 kg/m2) met inclusion criteria and were match-paired to pre-operative SC (n = 7) or', 'patients receiving bariatric surgery']","['aerobic exercise to standard medical care (EX+SC) prior to bariatric surgery', 'EX+SC', 'Adding pre-operative aerobic exercise to standard care', 'Pre-operative aerobic exercise']","['metabolic health', 'HMW adiponectin', 'Omental adipose tissue', 'omental total adiponectin', 'shorter operating time, and low leptin expression', 'leptin', 'length of stay', 'EX+SC enhanced metabolic flexibility', 'insulin sensitivity (Matsuda Index) and metabolic flexibility (indirect calorimetry', 'percent body fat', 'adiponectin and leptin, and operating time and length of hospital stay', 'Aerobic fitness (VO2peak), body composition (BodPod), and adipokines (adiponectin, leptin', 'length of hospital stay', 'low leptin expression', 'reduced total adiponectin', 'insulin sensitivity', 'metabolic health and surgical outcomes']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C3669124', 'cui_str': 'Omentum structure'}, {'cui': 'C0028977', 'cui_str': 'Omental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0260359,"RESULTS


SC tended to increase percent body fat (P = 0.06) after the intervention compared to EX+SC.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Gaitán', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Osinski', 'Affiliation': 'Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Rexrode', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Garmey', 'Affiliation': 'Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'J Hunter', 'Initials': 'JH', 'LastName': 'Mehaffey', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Taryn E', 'Initials': 'TE', 'LastName': 'Hassinger', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Kranz', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Coleen A', 'Initials': 'CA', 'LastName': 'McNamara', 'Affiliation': 'Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Hallowell', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, United States of America.'}]",PloS one,['10.1371/journal.pone.0239130']
2255,33006997,Couples data from north-western Tanzania: Insights from a survey of male partners of women enrolled in the MAISHA cluster randomized trial of an intimate partner violence prevention intervention.,"INTRODUCTION


Globally, around 30% of ever-partnered women have experienced physical and/or sexual intimate partner violence (IPV) during their lifetime. To date, most research into causes and prevention of IPV involves surveys of women, with little research into risk-factors for male perpetration. This paper describes a survey of male partners of women participating in the MAISHA cluster randomised trial (CRT) of an IPV prevention intervention, in Mwanza City, Tanzania. Using linked couples' data, we explore man-, woman-, and relationship-/household-level factors associated with physical and sexual IPV.
METHODS


Women were interviewed at baseline and 29-months follow-up. At follow-up, women were asked for consent to invite their partner to participate in the male survey. We describe response rates for the women's follow-up and male partners' surveys, and identify factors associated with women's consent to approach partners. Multivariate logistic regression was used to explore factors associated with women's past-year experiences of physical and sexual IPV.
RESULTS


512 (65%) partnered women consented for the partner to be approached, higher among intervention than control women. 425 (83%) male partners were interviewed. Women consenting were disproportionately likely to be in longer-term relationships. Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm. Factors associated with increased odds of physical IPV were women's childhood experiences of abuse, young age, women's lower income and women's attitudes justifying IPV. Sexual IPV was associated with women's childhood experiences of abuse, young age, educational disparity within couple, men's alcohol use and women's poor mental health.
CONCLUSIONS


We successfully conducted a survey of male partners with the full consent of women trial participants. The breadth of factors associated with IPV demonstrates the need for IPV prevention interventions to work with women and men, and specifically couples. Interventions should address risk-factors for both physical and sexual IPV.",2020,"Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm.","['425 (83%) male partners were interviewed', 'Women were interviewed at baseline and 29-months follow-up', 'male partners of women participating in the MAISHA cluster randomised trial (CRT) of an', 'male partners with the full consent of women trial participants', 'Couples data from north-western Tanzania', 'male partners of women enrolled in the MAISHA cluster randomized trial of an intimate partner violence prevention intervention']","['IPV prevention intervention, in Mwanza City, Tanzania', 'Sexual IPV']","['physical IPV', 'physical and/or sexual intimate partner violence (IPV']","[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",512.0,0.0520799,"Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Abramsky', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Kapinga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Christian Holm', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ramadhan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Stöckl', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0240112']
2256,33008455,Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial.,"BACKGROUND


Physician shortage is a major barrier to hypertension (HTN) control in Ghana, with only one physician to 10,000 patients in 2015, thus limiting its capacity for HTN control at the primary care level such as the Community Health Planning and Services (CHPS) compounds, where most Ghanaians receive care. A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating provider- and systems-level barriers to optimal HTN control. Despite its effectiveness, TASSH remains untested in CHPS zones. Additionally, primary care practices in low- and middle-income countries (LMICs) lack resources and expertise needed to coordinate multilevel system changes without assistance. The proposed study will evaluate the effectiveness of practice facilitation (PF) as a quality improvement strategy for implementing TASSH within CHPS zones in Ghana.
METHODS


Guided by the Consolidated Framework for Implementation Research and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we will evaluate, in a hybrid clinical effectiveness-implementation design, the effect of PF on the uptake of an evidence-based TASSH, among 700 adults who present to 70 CHPS zones with uncontrolled HTN. Components of the PF strategy include (a) an advisory board that provides leadership support for implementing the intervention within the CHPS zones and (b) trained task-strengthening facilitators (TSFs) who serve as practice coaches to provide training, and performance feedback to community health officers (CHOs) who will deliver TASSH at the CHPS zones. For this purpose, the TSFs are trained to identify, counsel, and refer adults with uncontrolled HTN to community health centers in Bono East Region of Ghana.
DISCUSSION


Uptake of community-based evidence-supported interventions for hypertension control in Ghana is urgently needed to address the CVD epidemic and its associated morbidity, mortality, and societal costs. Findings from this study will provide policymakers and other stakeholders the ""how to do it"" empirical literature on the uptake of evidence-based task-strengthening interventions for HTN control in Ghana and will serve as a model for similar action in other low, middle-income countries.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03490695 . Registered on 6 April 2018.
PROTOCOL VERSION AND DATE


Version 1, date: 21 August, 2019.",2020,A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating provider- and systems-level barriers to optimal HTN control.,"['700 adults who present to 70 CHPS zones with uncontrolled HTN', 'adults with uncontrolled HTN to community health centers in Bono East Region of Ghana', 'Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana']","['Task-Strengthening Strategy', 'Task-Shifting Strategy for HTN control (TASSH', 'practice facilitation (PF', 'TASSH']",[],"[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0242886', 'cui_str': 'Community Health Planning'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}]","[{'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]",[],700.0,0.101011,A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating provider- and systems-level barriers to optimal HTN control.,"[{'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, P.O. Box 200, Kintampo, Ghana. kwakupoku.asante@kintampo-hrc.org.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Iwelunmor', 'Affiliation': 'Department of Behavioral Science and Health Education, College for Public Health and Social Justice, Saint Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Kingsley', 'Initials': 'K', 'LastName': 'Apusiga', 'Affiliation': 'Department of Physiology, School of Medical Science, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Gyamfi', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Nyame', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, P.O. Box 200, Kintampo, Ghana.'}, {'ForeName': 'Kezia Gladys Amaning', 'Initials': 'KGA', 'LastName': 'Adjei', 'Affiliation': 'Department of Physiology, School of Medical Science, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Aifah', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Adjei', 'Affiliation': 'Kintampo Health Research Centre, Ghana Health Service, P.O. Box 200, Kintampo, Ghana.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Onakomaiya', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Chaplin', 'Affiliation': ""Department of Psychology, St. John's University, Queens, NY, USA.""}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Plange-Rhule', 'Affiliation': 'Department of Physiology, School of Medical Science, Kwame Nkrumah University of Science & Technology, Kumasi, Ghana.'}]",Trials,['10.1186/s13063-020-04667-7']
2257,33008464,Effect of vitamin A on intestinal mucosal injury in pediatric patients receiving hematopoietic stem cell transplantation and chemotherapy: a quasai-randomized trial.,"OBJECTIVE


Vitamin A is involved in maintenance of gut mucosal integrity and normal immune function. However, it is unclear whether these functions of vitamin A have any beneficial effects in patients undergoing hematopoietic stem cell transplantation (HSCT). In this study, we aimed to examine the potential protective effect of vitamin A supplementation on gastrointestinal (GI) mucosal integrity in HSCT recipients using plasma citrulline as a surrogate marker of intestinal integrity.
RESULTS


We performed a quasi-randomized trial in 30 pediatric patients undergoing HSCT. Half (n = 15) of the patients received a single high dose of vitamin A (200,000 IU) before the conditioning regimen was given, and half (n = 15) did not. Clinical data of patients who developed post-transplant complications were recorded for 60 days after HSCT. There were no significant differences in mean plasma citrulline levels on day 7 after HSCT between the treatment and control groups (5.8 vs. 5.9 µmol/L, respectively). The incidence of mucositis and other complications were not different between the two groups within 60 days of HSCT. Vitamin A supplementation prior to HSCT in pediatric patients had no clinical benefit in protecting GI mucosal integrity.",2020,"There were no significant differences in mean plasma citrulline levels on day 7 after HSCT between the treatment and control groups (5.8 vs. 5.9 µmol/L, respectively).","['patients undergoing hematopoietic stem cell transplantation (HSCT', '30 pediatric patients undergoing HSCT', 'HSCT recipients', 'pediatric patients', 'pediatric patients receiving hematopoietic stem cell transplantation and chemotherapy']","['single high dose of vitamin A', 'Vitamin A supplementation', 'vitamin A supplementation', 'vitamin A']","['incidence of mucositis and other complications', 'mean plasma citrulline levels', 'intestinal mucosal injury', 'gastrointestinal (GI) mucosal integrity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1271643', 'cui_str': 'Plasma citrulline level'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",30.0,0.381862,"There were no significant differences in mean plasma citrulline levels on day 7 after HSCT between the treatment and control groups (5.8 vs. 5.9 µmol/L, respectively).","[{'ForeName': 'Ploy', 'Initials': 'P', 'LastName': 'Pattanakitsakul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nalinee', 'Initials': 'N', 'LastName': 'Chongviriyaphan', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Bangkok, 10400, Thailand.'}, {'ForeName': 'Samart', 'Initials': 'S', 'LastName': 'Pakakasama', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nopporn', 'Initials': 'N', 'LastName': 'Apiwattanakul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Bangkok, 10400, Thailand. np36@hotmail.com.'}]",BMC research notes,['10.1186/s13104-020-05307-8']
2258,33008479,"A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
TRIAL DESIGN


The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study.
PARTICIPANTS


Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above.
MAIN OUTCOMES


The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C.
RANDOMIZATION


Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method.
BLINDING (MASKING)


Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75).
TRIAL STATUS


Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
","['Male or female 6', '20\u2009years of age 5', 'Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023', 'Outpatients and inpatients 8', 'Pregnant and lactating 4', 'Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals', 'mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage']","['traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko', 'Kampo medicine, kakkonto with shosaikotokakikyosekko', 'Hypokalemic or taking oral furosemide', 'Kampo medicine and conventional treatment', 'KT (TJ-1@TSUMURA and Co.) and 2.5\u2009g of SSKKS (TJ-109@TSUMURA and Co', 'Kampo or Western medicines']","[""patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath"", 'median survival time', 'cough, sputum, malaise, and shortness of breath, a numeric rating scale', 'survival curves', 'number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath', 'duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0291753', 'cui_str': 'kakkon-to'}, {'cui': 'C1138004', 'cui_str': 'shosaiko-to'}, {'cui': 'C0752221', 'cui_str': 'Kampo Medicine'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]",,0.134129,"We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment.
","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. takayama@med.tohoku.ac.jp.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Namiki', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, 1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Akashi Clinic Kanda, 3-8, Kandaogawa-machi, Chiyoda-ku, Tokyo, 101-0052, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakae', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Akita University Graduate School of Medicine, 1-1-1, Hondo, Akita, 010-8543, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Ishinomaki Hospital, Nishimichishita-71, Hebita, Ishinomaki, 986-8522, Japan.'}, {'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Center for Kampo Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ishigami', 'Affiliation': 'Department of Cardiology, Yokohama City University Hospital, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Traditional Medicine, Faculty of Medicine, Toho University, 6-11-1, Omori-nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Mosaburo', 'Initials': 'M', 'LastName': 'Kainuma', 'Affiliation': 'Community Medicine Education Unit, Graduate School of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Nochioka', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Takagi', 'Affiliation': 'Clinical Research Data Center, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.'}]",Trials,['10.1186/s13063-020-04746-9']
2259,20995845,Trial of treatment of undulating fever by the pilosella [Hieracium].,,1946,,[],[],[],[],[],[],,0.0214379,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'GUERIN', 'Affiliation': ''}]",Revue de phytotherapie,[]
2260,20289716,The trial excision.,,1947,,[],[],[],[],[],[],,0.0280745,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'HUEBSCHMANN', 'Affiliation': ''}]",Deutsche medizinische Wochenschrift (1946),[]
2261,20292237,A one-year trial to rehabilitate TB patients from the Seine at work.,,1945,,[],[],[],[],[],[],,0.0205813,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'LAFOSSE', 'Affiliation': ''}]",Revue de la tuberculose,[]
2262,20293410,The introduction of the double resection bracket for the treatment of knee resections.,,1947,,['knee resections'],[],[],"[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",[],[],,0.0235106,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'HAGEN', 'Affiliation': ''}]",Wiener klinische Wochenschrift,[]
2263,20982449,UFI clinical trial.,,1946,,[],[],[],[],[],[],,0.142146,,"[{'ForeName': 'C P G', 'Initials': 'CP', 'LastName': 'WAKELY', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'BLUM', 'Affiliation': ''}]",Prensa medica argentina,[]
2264,20259207,"Trial of intestinal lambliase therapy with nivaquine or 3,038 R.P.",,1947,,"['or 3,038 R.P']",['intestinal lambliase therapy with nivaquine'],[],[],"[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017536', 'cui_str': 'Giardiasis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028222', 'cui_str': 'Nivaquine'}]",[],,0.0246567,,"[{'ForeName': '', 'Initials': '', 'LastName': 'MAIRE', 'Affiliation': ''}]",Archives des maladies de l'appareil digestif et des maladies de la nutrition,[]
2265,20261207,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2266,20261209,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2267,20261213,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2268,20261218,The second trial in Nuremberg.,,1947,,[],[],[],[],[],[],,0.0144772,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2269,20261222,The second trial in Nuremberg.,,1947,,[],[],[],[],[],[],,0.0144772,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2270,20261225,The second trial in Nuremberg.,,1947,,[],[],[],[],[],[],,0.0144772,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2271,20261229,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2272,20261233,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2273,20261237,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2274,20261241,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2275,20261244,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2276,20263282,The second trial in Nuremberg.,,1947,,[],[],[],[],[],[],,0.0144772,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2277,20263287,The second trial in Nuremberg.,,1947,,[],[],[],[],[],[],,0.0144772,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2278,20263290,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2279,20263294,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2280,20263298,The second Nuremberg trial.,,1947,,[],[],[],[],[],[],,0.0143138,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2281,20274747,The functioning of the vesicular sphincter in humans; Observation of a double intubation; Proof of morphine and fatty meals.,,1945,,[],['morphine and fatty meals'],[],[],"[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",[],,0.136444,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'CAROLI', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'VARAY', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'GILLES', 'Affiliation': ''}]",Archives des maladies de l'appareil digestif et des maladies de la nutrition,[]
2282,20274748,The functioning of the vesicular sphincter in humans; Observation of a double intubation; Meltzer-Lyon test; Role in pathology.,,1945,,[],[],[],[],[],[],,0.131903,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'CAROLI', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'VARAY', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'GILLES', 'Affiliation': ''}]",Archives des maladies de l'appareil digestif et des maladies de la nutrition,[]
2283,20248181,The second Nuremberg trial; Continuation of Handloser's cross examination.,,1947,,[],[],[],[],[],[],,0.0272851,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'SILLEVAERTS', 'Affiliation': ''}]",Bruxelles medical,[]
2284,20250985,Trial of systematization of strabismus and some derivations on its therapy.,,1946,,[],[],[],[],[],[],,0.0148973,,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'LOPEZ DOMINGUEZ', 'Affiliation': ''}]",Archivos de la Sociedad Oftalmologica Hispano-Americana,[]
2285,18905704,About the Kobrak trial.,,1947,,[],[],[],[],[],[],,0.0343663,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'DE BOURNONVILLE', 'Affiliation': ''}]",Acta oto-rhino-laryngologica Belgica,[]
2286,18908394,Trial Of the Treatment Of Mycoses With Sulfamidothiourea; Preliminary Note.,,1948,,[],[],[],[],[],[],,0.0157315,,"[{'ForeName': '', 'Initials': '', 'LastName': 'MORIAME', 'Affiliation': ''}]",Le Scalpel,[]
2287,18913212,Diinsulin clinical trial.,,1947,,[],[],[],[],[],[],,0.12776,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'BRULL', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DIVRY', 'Affiliation': ''}]",Revue medicale de Liege,[]
2288,18918103,Trial of intravenous novocaine treatment for visual disturbances caused by trypanocidal arsenicals.,,1947,,[],['intravenous novocaine'],['visual disturbances'],[],"[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0028460', 'cui_str': 'Novocaine'}]","[{'cui': 'C0547030', 'cui_str': 'Visual disturbance'}]",,0.021079,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'LOROFI', 'Affiliation': ''}]",La Presse medicale,[]
2289,18919140,Trial of treatment of acute anuria; on the various procedures of renal supplementation and in particular intraoperitoneal hemodialysis.,,1947,,['acute anuria'],['renal supplementation and in particular intraoperitoneal hemodialysis'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003460', 'cui_str': 'Anuria'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",[],,0.0139393,,"[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'REYMOND', 'Affiliation': ''}]",Journal des praticiens; revue generale de clinique et de therapeutique,[]
2290,18894231,An antimalarial trial in Medina del Campo.,,1948,,[],[],[],[],[],[],,0.0579706,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'DE PRADA', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'COLLADO', 'Affiliation': ''}]",La Medicina colonial,[]
2291,33014805,A Novel Nomogram to Predict Survival in Patients With Recurrence of Pancreatic Ductal Adenocarcinoma After Radical Resection.,"The post-progression survival (PPS) of patients with pancreatic ductal adenocarcinoma (PDAC) after radical resection is varied and influenced by the characteristics of tumor progression. We aimed to establish and validate a nomogram to predict PPS for PDAC patients after surgery. A total of 302 PDAC patients who had undergone curative resection from 2008 to 2018 were enrolled in this study and randomly divided into training and validation cohorts at a ratio of 3:1. The nomogram was established based on independent prognostic factors selected by LASSO and Cox regression and measured by the area under the receiver operating characteristic curve (AUC) and the concordance index (C-index). Significant prognostic factors included carbohydrate antigen 19-9 (CA19-9), lymph node (LN)9 metastasis, LN14 metastasis, LN16 metastasis, tumor differentiation, imaging-detected tumor size, local progression, liver-only metastasis, lung-only metastasis, and multiple metastases. The nomogram built on these factors showed powerful efficacy in PPS prediction, with C-index values of 0.751 (95% CI 0.692-0.0.810) and 0.710 (95% CI 0.645-0.755) for the training and validation cohorts, respectively. The AUC values for the 1-year and 2-year PSS rates were 0.745, 0.747, and 0.783, 0.748, respectively; these values were higher than those of the 8th tumor-node-metastasis (TNM) stage system. The exploration of risk factors and the establishment of a nomogram can provide new versions of personalized recurrence management for PDAC patients after surgery.",2020,"The nomogram built on these factors showed powerful efficacy in PPS prediction, with C-index values of 0.751 (95% CI 0.692-0.0.810) and 0.710 (95% CI 0.645-0.755) for the training and validation cohorts, respectively.","['Patients', 'PDAC patients after surgery', 'patients with pancreatic ductal adenocarcinoma (PDAC) after radical resection', '302 PDAC patients who had undergone curative resection from 2008 to 2018 were enrolled', 'Pancreatic Ductal Adenocarcinoma']",[],"['carbohydrate antigen 19-9 (CA19-9), lymph node (LN)9 metastasis, LN14 metastasis, LN16 metastasis, tumor differentiation, imaging-detected tumor size, local progression, liver-only metastasis, lung-only metastasis, and multiple metastases', 'post-progression survival (PPS', 'AUC values for the 1-year and 2-year PSS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}]",[],"[{'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",302.0,0.0246466,"The nomogram built on these factors showed powerful efficacy in PPS prediction, with C-index values of 0.751 (95% CI 0.692-0.0.810) and 0.710 (95% CI 0.645-0.755) for the training and validation cohorts, respectively.","[{'ForeName': 'Chaobin', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Pancreatobiliary Surgery, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Pancreatobiliary Surgery, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Pancreatobiliary Surgery, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shengping', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Pancreatobiliary Surgery, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01564']
2292,33014833,Radiotherapy Versus Surgery-Which Is Better for Patients With T1-2N0M0 Glottic Laryngeal Squamous Cell Carcinoma? Individualized Survival Prediction Based on Web-Based Nomograms.,"Background


Both radiotherapy and surgery are now recommended for early stage glottic laryngeal squamous cell carcinoma (LSCC), and both have their own advantages in patients with different characteristics. For each patient, it is hard to determine whether radiotherapy or surgery is more appropriate.
Methods


Patients with T1-2N0M0 glottic LSCC who received radiotherapy or surgery in the 2004-2016 SEER database were reviewed, then randomly divided into training and validation cohorts. Propensity score matching was used to eliminate the baseline variations, and competing risk analyses helped to exclude the effects of other causes of death. Based on univariate and multivariate analyses, we built two nomograms to visually predict the survival of each patient with different characteristics who received radiotherapy or surgery, then validated the accuracy in both training and validation cohorts. Using nomogramEx, we quantified the algorithms of the nomograms and put the nomograms on the websites.
Results


A total of 6538 patients in the SEER database were included. We found that therapy ( p  = 0.004), T stage ( p  < 0.001), age ( p  < 0.001), race ( p  < 0.044), grade ( p  = 0.001), and marital status ( p  < 0.001) were independent prognostic factors. Two nomograms were built to calculate the survival for each patient who received radiotherapy (C-index = 0.668 ± 0.050 in the training cohort and 0.578 ± 0.028 in the validation cohort) or underwent surgery (C-index = 0.772 ± 0.045 in the training cohort and 0.658 ± 0.090 in the validation cohort). Calibration plots showed the accuracy of the nomograms. Using the nomograms, we found that 3872 patients (59.22%) had no difference between the two therapies, 706 patients (10.80%) who received radiotherapy had better survival outcomes, and 1960 patients (29.98%) who underwent surgery had better survival outcome.
Conclusion


Nomograms were used to comprehensively calculate independent factors to determine which treatment (radiotherapy or surgery) is better for each patient. A website was used to offer guidance regarding surgery or radiation for patients and physicians.",2020,"Using the nomograms, we found that 3872 patients (59.22%) had no difference between the two therapies, 706 patients (10.80%) who received radiotherapy had better survival outcomes, and 1960 patients (29.98%) who underwent surgery had better survival outcome.
","['6538 patients in the SEER database were included', 'Patients', 'early stage glottic laryngeal squamous cell carcinoma (LSCC', 'With T1-2N0M0 Glottic Laryngeal Squamous Cell Carcinoma', 'patients with different characteristics', 'Methods\n\n\nPatients with T1-2N0M0 glottic LSCC who received radiotherapy or surgery in the 2004-2016 SEER database']","['Radiotherapy Versus Surgery', 'radiotherapy', '\n\n\nBoth radiotherapy and surgery']","['marital status', 'survival outcome', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242638', 'cui_str': 'Surveillance, Epidemiology, and End Results Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0280324', 'cui_str': 'Squamous cell carcinoma of larynx'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024819', 'cui_str': 'Marital status'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6538.0,0.0829077,"Using the nomograms, we found that 3872 patients (59.22%) had no difference between the two therapies, 706 patients (10.80%) who received radiotherapy had better survival outcomes, and 1960 patients (29.98%) who underwent surgery had better survival outcome.
","[{'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Center for Tumor Diagnosis and Therapy, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shali', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Center for Tumor Diagnosis and Therapy, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minghe', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Center for Tumor Diagnosis and Therapy, Jinshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Eye and ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Radiation Oncology, Eye and ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Tiankui', 'Initials': 'T', 'LastName': 'Qiao', 'Affiliation': 'Center for Tumor Diagnosis and Therapy, Jinshan Hospital, Fudan University, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01669']
2293,33014902,Endoscopic Versus Microscopic Cartilage Myringoplasty in Chronic Otitis Media.,"Introduction


Operations on the tympanic membrane of the middle ear, myringoplasty, and tympanoplasty are now widely accepted, and attempts are underway all over the world to standardize the surgical techniques. This study aimed to compare postoperative outcomes of endoscopic and microscopic cartilage myringoplasty in patients suffering from chronic otitis media (COM).
Materials and Methods


This clinical trial study compared 130 patients with COM who underwent transcanal endoscopic myringoplasty by repairing perforation using auricular concha cartilage under general anesthesia (n=75) and conventional repairing method by postauricular incision and tympanomeatal flap elevation under microscopic surgery (n=55).
Results


According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group. Moreover, lower recovery time and post-operative pain were reported in patients who underwent the endoscopic approach, compared to those who treated with the conventional repairing method (P<0.001).
Conclusion


Endoscopic myringoplasty technique is a safe and effective way to improve hearing loss as much as the conventional method. However, due to the lower recovery time and post-operative pain, it seems to be the method of choice in myringoplasty surgery.",2020,"According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group.","['n=55', 'Chronic Otitis Media', '130 patients with COM who underwent', 'patients suffering from chronic otitis media (COM']","['transcanal endoscopic myringoplasty by repairing perforation using auricular concha cartilage under general anesthesia (n=75) and conventional repairing method by postauricular incision and tympanomeatal flap elevation under microscopic surgery', 'endoscopic and microscopic cartilage myringoplasty', 'Endoscopic\xa0Versus\xa0Microscopic Cartilage']","['hearing loss', 'hearing gain scores', 'hearing gain', 'lower recovery time and post-operative pain']","[{'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0229316', 'cui_str': 'Concha of ear structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0457827', 'cui_str': 'Postauricular incision'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",130.0,0.020769,"According to the results, there was no significant difference between the two groups in terms of hearing gain 1, 6, and 12 months after surgery (P=0.063); however, higher hearing gain scores were observed in the endoscopic group.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Daneshi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Daneshvar', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farhadi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Mohebbi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'Shabahang', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Hosseinzadeh', 'Affiliation': 'ENT and Head & Neck Research Center , The\xa0 Five Senses Health Institute , Iran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2020.44015.2453']
2294,33014907,Cryosurgery Vs Trichloroacetic Acid Chemical Cautery for the Treatment of Hypertrophied Nasal Turbinate: A Comparative Study.,"Introduction


The Study Aimed To Compare The Results of Cryosurgery With Trichloroacetic Acid Chemical (TCA) Cautery For The Treatment of Hypertrophied Nasal Turbinates.
Materials and Methods


This was a prospective study of 70 patients with nasal obstruction due to hypertrophied nasal turbinates who were randomly divided in 2 groups of 35 each. In group 1, patients underwent inferior nasal turbinate reduction by cryosurgery and in group 2 patients with cautery by 50 % TCA. The patients were evaluated using SNOT-20 score pre and postoperatively on 6th month.
Results


Significant improvement in symptoms was seen in 28 patients (80 %) in group 1 and in 10 patients (28.57%) in group 2..Improvement in average SNOT Score after cauterization of hypertrophied nasal turbinates by cryosurgery was from 55(severe) to 16(mild) and by TCA was from 54(severe) to 32(mod) in 6 months and this was statistically significant (P<0.001). Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
Conclusion


The use of cryosurgical treatment for hypertrophied nasal turbinates is a safe, curative method as compared to that of TCA cautery which is less curative and with more complications.",2020,"Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
","['Hypertrophied Nasal Turbinate', '70 patients with nasal obstruction due to hypertrophied nasal turbinates who were randomly divided in 2 groups of 35 each']","['TCA cautery', 'Trichloroacetic Acid Chemical (TCA) Cautery', 'Cryosurgery Vs Trichloroacetic Acid Chemical Cautery', 'TCA', 'cautery by 50 % TCA']","['symptoms', 'Complications like bleeding, scarring, infection and adhesion formation', 'complications scarring', 'average SNOT Score']","[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0155840', 'cui_str': 'Hypertrophy of nasal turbinates'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0441495', 'cui_str': 'Chemocautery - action'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0194224,"Complications like bleeding, scarring, infection and adhesion formation were more with TCA than that of cryosurgery group and among these complications scarring was statistically significant (P =0.003).
","[{'ForeName': 'Satish S', 'Initials': 'SS', 'LastName': 'Satpute', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Samir V', 'Initials': 'SV', 'LastName': 'Joshi', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, BJ Government Medical College, Pune, India.'}, {'ForeName': 'Ripudaman', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Prabha', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Keche', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, SVN Govt Medical College, Yavatmal, India.'}, {'ForeName': 'Nitin M', 'Initials': 'NM', 'LastName': 'Nagarkar', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.'}]",Iranian journal of otorhinolaryngology,['10.22038/ijorl.2019.39039.2293']
2295,33015151,"Educational Intervention Improved Parental Knowledge, Attitudes, and Practices (KAP) and Adherence of Patients with Celiac Disease to Gluten-Free Diet.","Background


Raising the knowledge level though education for a celiac disease patient's parents could improve the parent's adherence and practice and consequently recover the patient's adherence and symptoms and increase the patient's compliance.
Aim


The present study was aimed at assessing the knowledge, attitudes, and practices (KAP) of parents who have children with celiac disease aged from 2 to 15 years old and the change in self-reported patient's adherence pre-/posteducational intervention.
Method


This intervention study was designed as a quasiexperiment with evaluation pre-/post intervention analyses. Two educational sessions were carried for the parents of CD patients. A reliable and valid questionnaire was used to assess all independent variables pre-/post intervention. The parents were asked to complete the questionnaire pre and post the education sessions. The time between the sessions was two weeks.
Results


100 parents were recruited, and 40 parents participated and completed the study. Baseline parent's knowledge was significantly associated with the source of information ( p  value = 0.02), while the patient's adherence was associated with the onset of disease ( p  value = 0.04). There were significant differences in the parent's KAP and patient's adherence between pre- and posteducational intervention ( p  value was ≤0.001, for all variables).
Conclusion


Based on the results, this study suggested that the educational intervention increased the parent's KAP and improved the patient's adherence to the gluten-free diet significantly, which may lead to improvement in the celiac disease patients' health outcomes.",2020,"There were significant differences in the parent's KAP and patient's adherence between pre- and posteducational intervention ( p  value was ≤0.001, for all variables).
","['Patients with Celiac Disease to Gluten-Free Diet', ""parents who have children with celiac disease aged from 2 to 15 years old and the change in self-reported patient's adherence pre-/posteducational intervention"", '100 parents were recruited, and 40 parents participated and completed the study']",['Educational Intervention'],"['Parental Knowledge, Attitudes, and Practices (KAP) and Adherence', 'knowledge, attitudes, and practices (KAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",100.0,0.0306829,"There were significant differences in the parent's KAP and patient's adherence between pre- and posteducational intervention ( p  value was ≤0.001, for all variables).
","[{'ForeName': 'Nour Amin', 'Initials': 'NA', 'LastName': 'Elsahoryi', 'Affiliation': 'Nutrition Department, Faculty of Pharmacy and Medical Sciences, University of Petra, P.O. Box 961343, Amman 11196, Jordan.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Altamimi', 'Affiliation': 'Pediatric Department-Faculty of Medicine, Jordan University of Science and Technology, P.O. Box 3030, Irbid 21210, Jordan.'}, {'ForeName': 'Hadil Shafee', 'Initials': 'HS', 'LastName': 'Subih', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, P.O. Box 3030, Irbid 21210, Jordan.'}, {'ForeName': 'Fwziah Jammal', 'Initials': 'FJ', 'LastName': 'Hammad', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University of Science and Technology, P.O. Box 3030, Irbid 21210, Jordan.'}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Science, Queen's University Belfast, Belfast, UK BT12 6BJ.""}]",International journal of food science,['10.1155/2020/8850594']
2296,33015164,The Effects of Music Intervention on Pallidum-DMN Circuit of Schizophrenia.,"Music intervention has been applied to improve symptoms of schizophrenic subjects as a complementary treatment in medicine. Although the psychiatric symptoms, especially for motivation and emotion, could be increased in schizophrenia, the underlying neural mechanisms remain poorly understood. We employed a longitudinal study to measure the alteration of striatum functional networks in schizophrenic subjects undergoing Mozart music listening using resting-state functional magnetic resonance imaging (fMRI). Forty-five schizophrenic inpatients were recruited and randomly assigned to two groups. Under the standard care with antipsychotic medication, one group received music intervention for 1 month and the other group is set as control. Both schizophrenic groups were compared to healthy subjects. Resting-state fMRI was acquired from schizophrenic subjects at baseline and after one-month music intervention and from healthy subjects at baseline. Striatum network was assessed through seed-based static and dynamic functional connectivity (FC) analyses. After music intervention, increased static FC was observed between pallidum and ventral hippocampus in schizophrenic subjects. Increased dynamic FCs were also found between pallidus and subregions of default mode network (DMN), including cerebellum crus and posterior cingulate cortex. Moreover, static pallidus-hippocampus FC increment was positively correlated with the improvement of negative symptoms in schizophrenic subjects. Together, these findings provided evidence that music intervention might have an effect on the FC of the striatum-DMN circuit and might be related to the remission of symptoms of schizophrenia.",2020,"Moreover, static pallidus-hippocampus FC increment was positively correlated with the improvement of negative symptoms in schizophrenic subjects.","['Forty-five schizophrenic inpatients', 'schizophrenic subjects undergoing']","['Mozart music listening using resting-state functional magnetic resonance imaging (fMRI', 'music intervention', 'Music intervention', 'Music Intervention']","['static pallidus-hippocampus FC increment', 'Pallidum-DMN Circuit of Schizophrenia', 'Increased dynamic FCs', 'static FC', 'negative symptoms']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0017651', 'cui_str': 'Globus pallidus structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",45.0,0.0182243,"Moreover, static pallidus-hippocampus FC increment was positively correlated with the improvement of negative symptoms in schizophrenic subjects.","[{'ForeName': 'Yutong', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu 610054, China.'}]",BioMed research international,['10.1155/2020/4107065']
2297,33015220,Protocol and Feasibility-Randomized Trial of Telehealth Delivery for a Multicomponent Upper Extremity Intervention in Infants With Asymmetric Cerebral Palsy.,"Background


Past work showed that an  in-person , therapist-guided, parent-implemented multicomponent intervention increased the motor functioning of the more affected upper extremity (UE) in infants with asymmetric cerebral palsy. The authors document treatment fidelity and provide initial testing of  telehealth  intervention delivery in a new subject sample.
Methods


The authors adapted the intervention manual used in the previous trial for telehealth. Infants (6-24 months) were randomly assigned to intervention (n = 7) or waitlist (n = 6). The intervention prescribed soft-constraint wear on the less affected UE for 6 hours, 5 d/wk, and exercises. After an initial in-person training session, three 15- to 45-minute telehealth sessions were performed.
Results


Median weekly constraint wear was 21 hours (interquartile range = 10.3-29.7); average parent-treatment fidelity was 95.7% (SD 11.2). A significant large (Cohen  d  = 0.92) between-group differences occurred on fine motor functioning of more affected UEs.
Conclusion


The telehealth intervention was feasible and potentially effective, but a larger trial is needed to evaluate efficacy.",2020,"A significant large (Cohen  d  = 0.92) between-group differences occurred on fine motor functioning of more affected UEs.
","['Infants With Asymmetric Cerebral Palsy', 'Infants (6-24 months', 'infants with asymmetric cerebral palsy']",['Multicomponent Upper Extremity Intervention'],['fine motor functioning of more affected UEs'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",,0.059443,"A significant large (Cohen  d  = 0.92) between-group differences occurred on fine motor functioning of more affected UEs.
","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pietruszewski', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burkhardt', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Yoder', 'Affiliation': 'Department of Special Education, Peabody College of Education, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Heathcock', 'Affiliation': 'School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Lewandowski', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Nathalie L', 'Initials': 'NL', 'LastName': 'Maitre', 'Affiliation': ""Center for Perinatal Research at the Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH, USA.""}]",Child neurology open,['10.1177/2329048X20946214']
2298,33015244,Hand and torso pre-cooling does not enhance subsequent high-intensity cycling or cognitive performance in heat.,"The purpose of this study was to compare the separate and combined effects of two practical cooling methods (hand and torso) used prior to exercise on subsequent high-intensity cycling performance in heat. Ten trained male cyclists (V̇O 2 peak: 65.7 ± 10.7 ml.kg -1 .min -1 ) performed four experimental trials (randomised within-subjects design) involving 30-min of pre-cooling (20-min seated; PRE-COOL, 10 min warm-up; PRE-COOL+WUP), while using a: (1) hand-cooling glove (CG); (2) cooling jacket (CJ); (3) both CG and CJ (CG+J); or (4) no-cooling (NC) control, followed by a cycling race simulation protocol (all performed in 35.0 ± 0.6°C and 56.6 ± 4.5% RH). During the 30-min of pre-cooling, no reductions in core (Tc) or mean skin temperature (Tsk) occurred; however, Tsk remained lower in the CJ and CG+J trials compared to NC and CG (p = 0.002-0.040,  d = 0.55-1.01). Thermal sensation ratings also indicated that participants felt ""hotter"" during NC compared to all other trials during both PRE-COOL and PRE-COOL+WUP (p = 0.001-0.015,  d = 1.0-2.19), plus the early stages of exercise (sets 1-2; p = 0.005-0.050,  d = 0.56-1.22). Following cooling, no differences were found for absolute Tc and Tsk responses between trials over the entire exercise protocol (p > 0.05). Exercise and cognitive (working memory) performance also did not differ between trials (p = 0.843); however, cognitive performance improved over time in all trials (p < 0.001). In summary, pre-cooling (20-min seated and 10-min warm-up) in heat did not improve subsequent high-intensity cycling performance, cognitive responses and associated thermoregulatory strain (Tc and Tsk) compared to control.",2019,"Exercise and cognitive (working memory) performance also did not differ between trials (p = 0.843); however, cognitive performance improved over time in all trials (p < 0.001).","['heat', 'Ten trained male cyclists (V̇O 2 peak: 65.7 ± 10.7 ml.kg -1 .min']","['pre-cooling (20-min seated; PRE-COOL, 10 min warm-up', 'practical cooling methods (hand and torso', ' PRE-COOL+WUP), while using a: (1) hand-cooling glove (CG); (2) cooling jacket (CJ); (3) both CG and CJ (CG+J); or (4) no-cooling (NC) control, followed by a cycling race simulation protocol']","['core (Tc) or mean skin temperature (Tsk', 'absolute Tc and Tsk responses', 'cognitive performance', 'Exercise and cognitive (working memory) performance', 'subsequent high-intensity cycling performance, cognitive responses and associated thermoregulatory strain (Tc and Tsk', 'Thermal sensation ratings']","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C5191365', 'cui_str': '10.7'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0453944', 'cui_str': 'Jacket'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}]",10.0,0.057855,"Exercise and cognitive (working memory) performance also did not differ between trials (p = 0.843); however, cognitive performance improved over time in all trials (p < 0.001).","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Maroni', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dawson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Landers', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wallman', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}]","Temperature (Austin, Tex.)",['10.1080/23328940.2019.1631731']
2299,33015542,Comparison of anti-inflammatory effects of eye drops formulations after uncomplicated cataract surgery.,"Aim


The aim of this study is to compare the efficacy of different dexamethasone eye drops formulations in controlling postoperative inflammation.
Methods


Cataract surgery was carried out in 72 patients (35 males) divided into two groups: group A (36 patients, mean age = 78.0 ± 5.6) received four times daily for 2 weeks a suspension containing tobramycin 0.3% mg/ml + dexamethasone 0.1% mg/ml, and group B (36 patients, mean age = 76.2 ± 6.8) a solution containing tobramycin 0.3% mg/ml + dexamethasone 0.1% mg/ml. Both groups received ofloxacin 0.5% four times daily for 7 days, and nepafenac 0.1% three times daily for 3 weeks. Best-corrected visual acuity, intraocular pressure, corneal thickness, endothelial cells count, aqueous flare and macular thickness were evaluated preoperatively and at 1 day, 15 days, 1 and 2 months.
Results


In group A, intraocular pressure, corneal thickness and aqueous humour flare values preoperatively and at the end of follow-up were 14.3 ± 1.8 and 13.2 ± 1.8 mmHg, 546.4 ± 34.6 and 539.6 ± 36.1 µm, 11.84 ± 4.44 and 13.52 ± 5.54 ph/ms, respectively, with no statistically significant difference. In group B, intraocular pressure, corneal thickness and aqueous humour flare values preoperatively and at the end of follow-up were 14.3 ± 1.5 and 13.1 ± 1.7 mmHg, 552.9 ± 37.4 and 548.1 ± 39.3 µm, 11.45 ± 4.06 and 13.73 ± 4.99 ph/ms, respectively, with no statistically significant difference. No difference was detected in the macular thickness values in the parafoveal area preoperatively and at 2 months follow-up in group A (332.18 ± 16.19 and 337.71 ± 16.33 µm) and group B (329.11 ± 18.28 and 334.37 ± 20.86 µm), respectively.
Conclusion


The two different formulations of dexamethasone eye drops reached the same anti-inflammatory effects.",2020,"No difference was detected in the macular thickness values in the parafoveal area preoperatively and at 2 months follow-up in group A (332.18 ± 16.19 and 337.71 ± 16.33 µm) and group B (329.11 ± 18.28 and 334.37 ± 20.86 µm), respectively.
","['72 patients (35 males) divided into two groups: group A (36 patients, mean age\u2009=\u200978.0\u2009±\u20095.6', 'uncomplicated cataract surgery']","['Methods\n\n\nCataract surgery', 'dexamethasone', 'ofloxacin', 'solution containing tobramycin 0.3% mg/ml\u2009+\u2009dexamethasone 0.1% mg/ml', 'suspension containing tobramycin 0.3% mg/ml\u2009+\u2009dexamethasone', 'dexamethasone eye drops formulations']","['Best-corrected visual acuity, intraocular pressure, corneal thickness, endothelial cells count, aqueous flare and macular thickness', 'intraocular pressure, corneal thickness and aqueous humour flare values', 'macular thickness values', 'same anti-inflammatory effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0028902', 'cui_str': 'Ofloxacin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0304706', 'cui_str': 'Dexamethasone-containing product in ocular dose form'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0003662', 'cui_str': 'Aqueous humor'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",72.0,0.0535358,"No difference was detected in the macular thickness values in the parafoveal area preoperatively and at 2 months follow-up in group A (332.18 ± 16.19 and 337.71 ± 16.33 µm) and group B (329.11 ± 18.28 and 334.37 ± 20.86 µm), respectively.
","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cagini', 'Affiliation': 'Department of Biomedical and Surgical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, Piazza Menghini 1, 06126 Perugia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pellegrino', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Cerquaglia', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Modugno', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Messina', 'Affiliation': 'Department of Surgery and Biomedical Sciences, University of Perugia, Perugia, Italy.'}]",Therapeutic advances in ophthalmology,['10.1177/2515841420924304']
2300,33015562,Esophagoduodenoscopy or colonoscopy: which should be done first?,"Objectives


Esophagoduodenoscopy and colonoscopy can be done as bidirectional endoscopy in the same session. The aim of this study was to compare anesthetic requirements and hemodynamic effects in esophagoduodenoscopy or colonoscopy done first for bidirectional endoscopy.
Material and Methods


Eighty patients, aged 18-70 years with an American Society of Anesthesiologists Classification (ASA) as I-III, were included randomly into this study. The patients were allocated into two groups: Group C: first colonoscopy followed by esophagoduodenoscopy. Group E: first esophagoduodenoscopy followed by colonoscopy. All patients received standard anesthesia with 1 µg/kg fentanyl and 1 mg/kg propofol. Demographical variables, Heart rate SpO 2 , Ramsey Sedation Score were recorded every 10 minutes. Total propofol consumption, retching during esophagoduodenoscopy and time to reach cecum were also recorded. Endoscopist and patient satisfaction were questioned.
Results


Retching during esophagoduodenoscopy was not statistically significantly different in both groups. Total procedure duration and esophagoduodenoscopy duration were statistically significant longer in Group E. Complication frequency was higher in Group E. Endoscopist and patient satisfaction were lower in Group E. There was no difference in time to reach the cecum and the recovering period. Additional propofol dose was increased in Group E.
Conclusion


Regarding shorter procedural duration, lower consumption amount of propofol and fewer complications, it could be a better choice to start bidirectional procedure with colonoscopy first.",2020,Total procedure duration and esophagoduodenoscopy duration were statistically significant longer in Group E. Complication frequency was higher in Group E. Endoscopist and patient satisfaction were lower in Group E.,"['Eighty patients, aged 18-70 years with an American Society of Anesthesiologists Classification (ASA) as I-III']","['Esophagoduodenoscopy or colonoscopy', 'Esophagoduodenoscopy and colonoscopy', 'esophagoduodenoscopy followed by colonoscopy', 'colonoscopy followed by esophagoduodenoscopy', 'standard anesthesia with 1 µg/kg fentanyl and 1 mg/kg propofol']","['Total propofol consumption, retching during esophagoduodenoscopy and time to reach cecum', 'time to reach the cecum', 'Demographical variables, Heart rate SpO 2 , Ramsey Sedation Score', 'Complication frequency', 'Retching', 'Total procedure duration and esophagoduodenoscopy duration']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",80.0,0.0310387,Total procedure duration and esophagoduodenoscopy duration were statistically significant longer in Group E. Complication frequency was higher in Group E. Endoscopist and patient satisfaction were lower in Group E.,"[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Sayın', 'Affiliation': 'Department of Anestesiology and Reanimation, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Bostancı', 'Affiliation': 'Department of General Surgery, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hacer Şebnem', 'Initials': 'HŞ', 'LastName': 'Türk', 'Affiliation': 'Department of Anestesiology and Reanimation, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Canan Tülay', 'Initials': 'CT', 'LastName': 'Işıl', 'Affiliation': 'Department of Anestesiology and Reanimation, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Department of Anestesiology and Reanimation, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Mihmanlı', 'Affiliation': 'Department of General Surgery, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Turkish journal of surgery,['10.5578/turkjsurg.4275']
2301,33015643,"Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial.","Background


Severe COVID-19 is characterised by inflammation and coagulation in the presence of complement system activation. We aimed to explore the potential benefit and safety of selectively blocking the anaphylatoxin and complement protein C5a with the monoclonal antibody IFX-1 (vilobelimab), in patients with severe COVID-19.
Methods


We did an exploratory, open-label, randomised phase 2 trial (part of the adaptive phase 2/3 PANAMO trial) of intravenous IFX-1 in adults with severe COVID-19 at three academic hospitals in the Netherlands. Eligibility criteria were age 18 years or older; severe pneumonia with pulmonary infiltrates consistent with pneumonia, a clinical history of severe shortness of breath within the past 14 days, or a need for non-invasive or invasive ventilation; severe disease defined as a ratio of partial pressure of arterial oxygen to fractional concentration of oxygen in inspired air (PaO 2 /FiO 2 ) between 100 mm Hg and 250 mm Hg in the supine position; and severe acute respiratory syndrome coronavirus 2 infection confirmed by RT-PCR. Patients were randomly assigned 1:1 to receive IFX-1 (up to seven doses of 800 mg intravenously) plus best supportive care (IFX-1 group) or best supportive care only (control group). The primary outcome was the percentage change in PaO 2 /FiO 2  in the supine position between baseline and day 5. Mortality at 28 days and treatment-emergent and serious adverse events were key secondary outcomes. The primary analysis was done in the intention-to-treat population and safety analyses were done in all patients according to treatment received. This trial is registered at ClinicalTrials.gov (NCT04333420).
Findings


Between March 31 and April 24, 2020, 30 patients were enrolled and randomly assigned to the IFX-1 group (n=15) or the control group (n=15). During the study it became clear that several patients could not be assessed regularly in the supine position because of severe hypoxaemia. It was therefore decided to focus on all PaO 2 /FiO 2  assessments (irrespective of position). At day 5 after randomisation, the mean PaO 2 /FiO 2  (irrespective of position) was 158 mm Hg (SD 63; range 84-265) in the IFX-1 group and 189 mm Hg (89; 71-329) in the control group. Analyses of the least squares mean relative change in PaO 2 /FiO 2  at day 5 showed no differences between treatment groups (17% change in the IFX-1 group  vs  41% in the control group; difference -24% [95% CI -58 to 9], p=0·15. Kaplan-Meier estimates of mortality by 28 days were 13% (95% CI 0-31) for the IFX-1 group and 27% (4-49) for the control group (adjusted hazard ratio for death 0·65 [95% CI 0·10-4·14]). The frequency of serious adverse events were similar between groups (nine [60%] in the IFX-1 group  vs  seven [47%] in the control group) and no deaths were considered related to treatment assignment. However, a smaller proportion of patients had pulmonary embolisms classed as serious in the IFX-1 group (two [13%]) than in the control group (six [40%]). Infections classed as serious were reported in three (20%) patients in the IFX-1 group versus five (33%) patients in the control group.
Interpretation


In this small exploratory phase 2 part of the PANAMO trial, C5a inhibition with IFX-1 appears to be safe in patients with severe COVID-19. The secondary outcome results in favour of IFX-1 are preliminary because the study was not powered on these endpoints, but they support the investigation of C5a inhibition with IFX-1 in a phase 3 trial using 28-day mortality as the primary endpoint.
Funding


InflaRx.",2020,The frequency of serious adverse events were similar between groups (nine [60%] in the IFX-1 group  vs  seven [47%] in the control group) and no deaths were considered related to treatment assignment.,"['patients with severe COVID-19', 'adults with severe COVID-19 at three academic hospitals in the Netherlands', 'Findings\n\n\nBetween March 31 and April 24, 2020, 30 patients', 'Eligibility criteria were age 18 years or older; severe pneumonia with pulmonary infiltrates consistent with pneumonia, a clinical history of severe shortness of breath within the past 14 days, or a need for non-invasive or invasive ventilation; severe disease defined as a ratio of partial pressure of arterial oxygen to fractional concentration of oxygen in inspired air (PaO 2 /FiO 2 ) between 100 mm Hg and 250 mm Hg in the supine position; and severe acute respiratory syndrome coronavirus 2 infection confirmed by RT-PCR', 'patients with severe COVID-19 (PANAMO']","['Anti-C5a antibody IFX-1 (vilobelimab', 'IFX-1 (up to seven doses of 800 mg intravenously) plus best supportive care (IFX-1 group) or best supportive care only (control group', 'anaphylatoxin and complement protein C5a with the monoclonal antibody IFX-1 (vilobelimab', 'IFX-1', 'intravenous IFX-1']","['Mortality', 'percentage change in PaO 2 /FiO 2  in the supine position', '28-day mortality', 'C5a inhibition with IFX-1', 'mortality', 'frequency of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}]","[{'cui': 'C0009521', 'cui_str': 'C5a Complement'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002791', 'cui_str': 'Anaphylatoxin'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009521', 'cui_str': 'C5a Complement'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.207088,The frequency of serious adverse events were similar between groups (nine [60%] in the IFX-1 group  vs  seven [47%] in the control group) and no deaths were considered related to treatment assignment.,"[{'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'de Bruin', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Busch', 'Affiliation': 'Department of Immunology, Maastricht UMC, Maastricht, Netherlands.'}, {'ForeName': 'Sjoerd A M E G', 'Initials': 'SAMEG', 'LastName': 'Timmermans', 'Affiliation': 'Department of Immunology, Maastricht UMC, Maastricht, Netherlands.'}, {'ForeName': 'Ingeborg E', 'Initials': 'IE', 'LastName': 'van Zeggeren', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koning', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Ter Horst', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Esther B', 'Initials': 'EB', 'LastName': 'Bulle', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Frank E H P', 'Initials': 'FEHP', 'LastName': 'van Baarle', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel C G', 'Initials': 'MCG', 'LastName': 'van de Poll', 'Affiliation': 'Department of Intensive Care, Maastricht UMC, Maastricht, Netherlands.'}, {'ForeName': 'E Marleen', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Clinical Pharmacy, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Intensive Care, Maastricht UMC, Maastricht, Netherlands.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Frederique', 'Initials': 'F', 'LastName': 'Paulus', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Lieuwe D', 'Initials': 'LD', 'LastName': 'Bos', 'Affiliation': 'Department of Intensive Care, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'W Joost', 'Initials': 'WJ', 'LastName': 'Wiersinga', 'Affiliation': 'Department of Infectious Diseases, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Witzenrath', 'Affiliation': 'Department of Infectious Diseases and Respiratory Medicine, Division of Pulmonary Inflammation, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rueckinger', 'Affiliation': 'Metronomia Clinical Research, Munich, Germany.'}, {'ForeName': 'Korinna', 'Initials': 'K', 'LastName': 'Pilz', 'Affiliation': 'InflaRx, Jena, Germany.'}, {'ForeName': 'Matthijs C', 'Initials': 'MC', 'LastName': 'Brouwer', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Ren-Feng', 'Initials': 'RF', 'LastName': 'Guo', 'Affiliation': 'InflaRx Pharmaceuticals, Ann Arbor, MI, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Heunks', 'Affiliation': 'Department of Intensive Care, Free University, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'van Paassen', 'Affiliation': 'Department of Immunology, Maastricht UMC, Maastricht, Netherlands.'}, {'ForeName': 'Niels C', 'Initials': 'NC', 'LastName': 'Riedemann', 'Affiliation': 'InflaRx, Jena, Germany.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'van de Beek', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.'}]",The Lancet Rheumatology,['10.1016/S2665-9913(20)30341-6']
2302,33015732,The nutritional and cardiovascular health benefits of rapeseed oil-fed farmed salmon in humans are not decreased compared with those of traditionally farmed salmon: a randomized controlled trial.,"PURPOSE


Farmed fish are increasingly raised on feeds containing vegetable oils, which affects their composition and possibly health properties. We investigated the effects of consuming farmed salmon, raised on different feeding regimes, on nutrient status and health outcomes in healthy subjects.
METHODS


Salmon were grown on feeds containing mainly fish oil (FO) or rapeseed oil (RO), resulting in an eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content of fillets of 2.1 or 0.9 g/100 g, respectively. In a randomized parallel controlled trial, 51 healthy subjects were allocated to consume 2 portions/week of FO salmon (n = 17), RO salmon (n = 17) or no additional salmon (Control, n = 17) as part of their habitual diet, for 18 weeks. We collected blood at 0, 9 and 18 weeks to measure omega-3 index (O3I) in red blood cells, plasma markers of cardiovascular risk, serum 25(OH)-vitamin D 3  (25(OH)D 3 ) and plasma trace elements.
RESULTS


After 18 weeks, O3I was similarly increased in subjects consuming 2 portions/week of FO or RO salmon compared to control (both p < 0.05). Serum 25(OH)D 3  was significantly higher, whereas plasma triacylglycerols were significantly lower in subjects consuming RO salmon compared to control (both p < 0.05). Heart rate was significantly lower in subjects consuming FO salmon after 9 weeks, compared to control (p < 0.01). Salmon consumption did not affect other markers.
CONCLUSION


Consuming two portions/week of salmon raised on rapeseed oil rather than fish oil increased the O3I and vitamin D status, and decreased plasma triacylglycerols. These outcomes endorse opportunities for developing more sustainable feeds within aquaculture food systems.
CLINICAL TRIAL REGISTRY


This trial was registered at clinicaltrials.gov as NCT01916434.",2020,"Heart rate was significantly lower in subjects consuming FO salmon after 9 weeks, compared to control (p < 0.01).","['51 healthy subjects', 'healthy subjects']","['RO salmon (n\u2009=\u200917) or no additional salmon (Control, n\u2009=\u200917) as part of their habitual diet', 'rapeseed oil-fed farmed salmon', 'feeds containing mainly fish oil (FO) or rapeseed oil (RO), resulting in an eicosapentaenoic acid (EPA)\u2009+\u2009docosahexaenoic acid (DHA', 'FO salmon']","['O3I and vitamin D status, and decreased plasma triacylglycerols', 'plasma triacylglycerols', 'omega-3 index (O3I) in red blood cells, plasma markers of cardiovascular risk, serum 25(OH)-vitamin D 3  (25(OH)D 3 ) and plasma trace elements', 'Heart rate', 'Serum 25(OH)D 3', 'Salmon consumption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",51.0,0.0670235,"Heart rate was significantly lower in subjects consuming FO salmon after 9 weeks, compared to control (p < 0.01).","[{'ForeName': 'Baukje', 'Initials': 'B', 'LastName': 'de Roos', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK. b.deroos@abdn.ac.uk.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bremner', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Monica B', 'Initials': 'MB', 'LastName': 'Betancor', 'Affiliation': 'Institute of Aquaculture, Stirling University, Stirling, UK.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Fraser', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Duthie', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Graham W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Sneddon', 'Affiliation': 'Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02396-w']
2303,33015813,"Effects of 4 weeks of Lactobacillus plantarum 299v supplementation on nutritional status, enteral nutrition tolerance, and quality of life in cancer patients receiving home enteral nutrition - a double-blind, randomized, and placebo-controlled trial.","OBJECTIVE


Several human trials have confirmed that Lactobacillus plantarum 299v (Lp299v) relief the gastrointestinal symptoms observed in patients with irritable bowel syndrome, such as nausea, vomiting, and diarrhea. These symptoms are similar to those associated with home enteral nutrition and they affect nutritional status as well as patients' quality of life. The aims of this study were to determine the effect of Lp299v on nutritional status, enteral formula tolerance, and quality of life in cancer patients.
PATIENTS AND METHODS


The current double-blind, randomized, and placebo-controlled study included 35 cancer patients receiving home enteral nutrition. There were 2 groups of participants consuming either 2 x 10^10 CFU of Lp299v (n=21) or placebo (n=14) for 4 weeks.
RESULTS


An increase in the serum albumin concentration was significantly higher in the Lp299v group than in the placebo group at the endpoint (p=0.032). Moreover, the changes in the frequency of vomiting and flatulence were significantly reduced at week 4 compared to baseline in the Lp299v group (p=0.0117). The improvement of quality of life was observed in both groups; however, with no statistically significant differences between the analyzed groups (p>0.05).
CONCLUSIONS


We have demonstrated that administration of Lp299v in cancer patients receiving home enteral nutrition may improve laboratory parameters, predominantly the concentration of albumin, however, overall it does not have an impact on nutritional status. Lp299v may reduce the gastrointestinal symptoms related to enteral nutrition; notwithstanding, the improvement of quality of life may be the result of enteral nutrition rather than the effect of administration of Lp299v.",2020,"The improvement of quality of life was observed in both groups; however, with no statistically significant differences between the analyzed groups (p>0.05).
","['cancer patients receiving', 'patients with irritable bowel syndrome', 'cancer patients', '35 cancer patients receiving home enteral nutrition', 'cancer patients receiving home enteral nutrition - a double-blind']","['Lactobacillus plantarum 299v supplementation', 'Lactobacillus plantarum 299v (Lp299v) relief', 'Lp299v', 'home enteral nutrition', 'placebo']","['serum albumin concentration', 'nutritional status, enteral nutrition tolerance, and quality of life', 'nausea, vomiting, and diarrhea', 'frequency of vomiting and flatulence', 'quality of life', 'nutritional status, enteral formula tolerance, and quality of life']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0311187', 'cui_str': 'Enteral formula'}]",35.0,0.214545,"The improvement of quality of life was observed in both groups; however, with no statistically significant differences between the analyzed groups (p>0.05).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaźmierczak-Siedlecka', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdańsk, Gdańsk, Poland. leokadia@gumed.edu.pl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Folwarski', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruszkowski', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Szafrański', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Makarewicz', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202009_23059']
2304,33015846,Comment on: Critical appraisal of an article: Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,,2020,,[],['laparoscopic umbilical hernia repair'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia'}]",[],,0.177639,,"[{'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Ramakrishna', 'Affiliation': 'Lakshmi Nursing Home, New bridge road, Bhadravathi, 577301, India.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Swarnalatha', 'Affiliation': 'Lakshmi Nursing Home, New bridge road, Bhadravathi, 577301, India.'}]",The British journal of surgery,['10.1002/bjs.12018']
2305,33015869,"Effects of saffron supplementation on oxidative/antioxidant status and severity of disease in ulcerative colitis patients: A randomized, double-blind, placebo-controlled study.","Supplementation with saffron helps improve antioxidant status. Oxidative stress plays an important role in ulcerative colitis (UC). The present study aimed to investigate the effect of saffron supplementation on disease severity and Oxidative/Antioxidant factors in patients with UC. This randomized double-blinded study was conducted on 80 mild to moderate UC patients. Participants were randomly divided into intervention (100 mg saffron/daily) and placebo (100 mg maltodextrin/daily) groups. Of all the participants, 75 completed the study. After 8 weeks, there were significantly increased in the mean score of simple clinical colitis activity index questionnaire (3.83 ± 1.78 to 3 ± 1.60, p = .004), the serum levels of total antioxidant capacity (2.68 ± 0.90 to 2.79 ± 0.87, p = .016), superoxide dismutase (60.69 ± 9.59 to 66.30 ± 10.79, p = .009) and glutathione peroxidase (22.05 ± 14.27 to 29.67 ± 17.97, p = .011) in patients received saffron compared to the placebo group. Whereas, there was no significant difference in serum levels of malondialdehyde between the two groups. Finally, dietary saffron as an alternative therapy may effective in improving antioxidant factors and reducing the severity of disease in UC patients.",2020,"After 8 weeks, there were significantly increased in the mean score of simple clinical colitis activity index questionnaire (3.83 ± 1.78 to 3 ± 1.60, p = .004), the serum levels of total antioxidant capacity (2.68 ± 0.90 to 2.79 ± 0.87, p = .016), superoxide dismutase (60.69 ± 9.59 to 66.30 ± 10.79, p = .009) and glutathione peroxidase (22.05 ± 14.27 to 29.67 ± 17.97, p = .011) in patients received saffron compared to the placebo group.","['patients with UC', 'ulcerative colitis patients', 'ulcerative colitis (UC', '80 mild to moderate UC patients']","['saffron supplementation', 'placebo']","['mean score of simple clinical colitis activity index questionnaire', 'superoxide dismutase', 'disease severity and Oxidative/Antioxidant factors', 'serum levels of malondialdehyde', 'antioxidant status', 'glutathione peroxidase', 'serum levels of total antioxidant capacity', 'oxidative/antioxidant status and severity of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.333796,"After 8 weeks, there were significantly increased in the mean score of simple clinical colitis activity index questionnaire (3.83 ± 1.78 to 3 ± 1.60, p = .004), the serum levels of total antioxidant capacity (2.68 ± 0.90 to 2.79 ± 0.87, p = .016), superoxide dismutase (60.69 ± 9.59 to 66.30 ± 10.79, p = .009) and glutathione peroxidase (22.05 ± 14.27 to 29.67 ± 17.97, p = .011) in patients received saffron compared to the placebo group.","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Tahvilian', 'Affiliation': 'Student Research Committee, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Masoodi', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Faghihi Kashani', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Heydarian', 'Affiliation': 'Student Research Committee, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'AghaFateme', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Cellular and Molecular Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Farsi', 'Affiliation': 'Student Research Committee, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6848']
2306,33015888,Effectiveness of adjuvant FOLFOX versus 5FU/LV in adults over age 65 with stage II and III colon cancer using a novel hybrid approach.,"PURPOSE


Estimates of cancer therapy effects can differ in clinical trials and clinical practice, partly due to underrepresentation of certain patient subgroups in trials. We utilize a hybrid approach combining clinical trial and real-world data to estimate the comparative effectiveness of two adjuvant chemotherapy regimens for colon cancer.
METHODS


We identified patients age 66 and older enrolled in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer. Similar patients were identified in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database initiating adjuvant chemotherapy with either 5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX). We used logistic regression to estimate the likelihood of trial enrollment as a function of age, sex, and substage. Using inverse odds of sampling weights (IOSW), we compared five-year mortality in patients randomized to FOLFOX versus 5FU using weighted Cox proportional hazards regression, the Nelson-Aalen estimator for cumulative hazards, and bootstrapping for 95% confidence intervals.
RESULTS


There were 690 trial participants and 3,834 SEER-Medicare patients. The SEER-Medicare population was older and had a higher proportion of stage IIIB and IIIC patients than the trial. After controlling for differences between populations, the IOSW 5-year HR was 1.21 (0.89, 1.65), slightly farther from the null than the trial estimate (HR=1.14, 95%CI: 0.87, 1.49).
CONCLUSIONS


This study supports mounting evidence of little to no incremental reduction in five-year mortality for FOLFOX versus 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.",2020,"This study supports mounting evidence of little to no incremental reduction in five-year mortality for FOLFOX versus 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.","['690 trial participants and 3,834 SEER-Medicare patients', 'older adults with stage II-III colon cancer', 'patients age 66 and older enrolled in the Multicenter International Study of', 'adults over age 65 with stage II and III colon cancer', 'colon cancer']","['FOLFOX versus 5FU', 'adjuvant FOLFOX versus 5FU/LV', 'Oxaliplatin/5FU-LV', '5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX', 'FOLFOX']","['sampling weights (IOSW', 'IOSW 5-year HR']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0807984', 'cui_str': 'Specimen weight'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.118313,"This study supports mounting evidence of little to no incremental reduction in five-year mortality for FOLFOX versus 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Lund', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Webster-Clark', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sharon Peacock', 'Initials': 'SP', 'LastName': 'Hinton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Shmuel', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Stürmer', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hanna K', 'Initials': 'HK', 'LastName': 'Sanoff', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.5148']
2307,33015912,Comparable quality of bowel preparation with single-day versus three-day low-residue diet: a randomized controlled trial.,"BACKGROUND AND AIMS


There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy.
METHODS


A non-inferiority, randomised, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomised to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level.
RESULTS


A total of 855 patients were randomised. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (p-value for non-inferiority <0.001). The percentage of patients with BBPS scores ≥ 8 was superior in 1-day LRD group (254 vs 221 in the 3-day LRD group, p=0.032). The 1-day regimen was better tolerated than the 3-day diet. A 47.7% (vs, 28.7%, p<0.05) of patients rated the One-day LRD as very easy to follow.
CONCLUSION


One-day LRD is non-inferior to three-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.",2020,One-day LRD is non-inferior to three-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.,"['average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy', '855 patients were randomised']","['single-day versus three-day low-residue diet', '1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment', 'standard laxative treatment']","['BBPS ≥2 in all colon segments', 'Adequate bowel preparation', 'Boston Bowel Preparation Scale (BBPS', 'percentage of patients with BBPS scores']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}]","[{'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",855.0,0.18648,One-day LRD is non-inferior to three-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.,"[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Machlab', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Martínez-Bauer', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'López', 'Affiliation': ""Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Piqué', 'Affiliation': 'Microbiology Section, Departament of Biology, Healthcare and Environment, Faculty of Pharmacy and Food Sciences, Universitat de Barcelona (UB), Barcelona, Spain.'}, {'ForeName': 'Valentí', 'Initials': 'V', 'LastName': 'Puig-Diví', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Junquera', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Lira', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Brullet', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Selva', 'Affiliation': ""Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Iglesias', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Calvet', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Campo', 'Affiliation': ""Gastroenterology Department, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT, Barcelona, Spain.""}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13860']
2308,33015924,"Polypharmacy, functional outcome, and treatment effect of intravenous alteplase for acute ischemic stroke.","BACKGROUND


Polypharmacy is an important challenge in clinical practice. We aimed at determining the effect of polypharmacy on functional outcome and treatment effect of alteplase in acute ischemic stroke.
METHODS


Post-hoc analysis of the randomized, placebo-controlled WAKE-UP trial of MRI-guided intravenous alteplase in unknown onset stroke. Polypharmacy was defined as intake of ≥5 medications at baseline. Comorbidities were assessed by the Charlson Comorbidity Index (CCI). The primary efficacy variable was favorable outcome defined by a score of 0-1 on the modified Rankin Scale at 90 days. We used logistic regression analysis to test for an association of polypharmacy with functional outcome, and for interaction of polypharmacy and the effect of thrombolysis.
RESULTS


Polypharmacy was present in 133/503 (26%) patients. Patients with polypharmacy were older (mean age 70 vs 64 years; P<0.0001) and had a higher score on the National Institutes of Health Stroke Scale at baseline (median 7 vs 5; P=0.0007). A comorbidity load defined by a CCI score ≥2 was more frequent in patients with polypharmacy (48% vs 8%; P<0.001). Polypharmacy was associated with lower odds of favorable outcome (adjusted odds ratio 0.50, 95% CI, 0.30-0.85; P=0.0099), while the CCI score was not. Treatment with alteplase was associated with higher odds of favorable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, P=0.29).
CONCLUSION


In stroke patients, polypharmacy is associated with worse functional outcome after intravenous thrombolysis independent of comorbidities. However, polypharmacy does not interact with the beneficial effect of alteplase.",2020,"Treatment with alteplase was associated with higher odds of favorable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, P=0.29).
",['acute ischemic stroke'],"['polypharmacy', 'MRI-guided intravenous alteplase', 'placebo', 'alteplase', 'intravenous alteplase']","['CCI score', 'National Institutes of Health Stroke Scale', 'Charlson Comorbidity Index (CCI', 'score of 0-1 on the modified Rankin Scale']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.0952879,"Treatment with alteplase was associated with higher odds of favorable outcome in both groups, with no heterogeneity of treatment effect (test for interaction of treatment and polypharmacy, P=0.29).
","[{'ForeName': 'Märit', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100, Villeurbanne, France.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Tae-Hee', 'Initials': 'TH', 'LastName': 'Cho', 'Affiliation': 'Department of Stroke Medicine, Université Claude Bernard Lyon 1, CREATIS CNRS UMR 5220-INSERM U1206, INSA-Lyon, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ebinger', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fiehler', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, University Avenue, Glasgow, G12 8QQ, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Galinovic', 'Affiliation': 'Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Königsberg', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': ""Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investigació Biomèdica de Girona (IDIBGI), Parc Hospitalari Martí i Julià de Salt - Edifici M2, 17190, Salt, Girona, Spain.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roy', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100, Villeurbanne, France.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Wouters', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, University of Melbourne, 245 Burgundy Street, Heidelberg, VIC, 3084, Victoria, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lemmens', 'Affiliation': 'Department of Neurology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, University Avenue, Glasgow, G12 8QQ, UK.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Department of Stroke Medicine, Université Claude Bernard Lyon 1, CREATIS CNRS UMR 5220-INSERM U1206, INSA-Lyon, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Pedraza', 'Affiliation': ""Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investigació Biomèdica de Girona (IDIBGI), Parc Hospitalari Martí i Julià de Salt - Edifici M2, 17190, Salt, Girona, Spain.""}, {'ForeName': 'Claus Z', 'Initials': 'CZ', 'LastName': 'Simonsen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, 8000, Aarhus, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Thomalla', 'Affiliation': 'Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.'}]",European journal of neurology,['10.1111/ene.14566']
2309,33015926,Effects of early nutritional intervention by a nutritional support team for patients with head and neck cancer undergoing chemoradiotherapy or radiotherapy.,"BACKGROUND


We analyzed the effects of early nutritional intervention by a nutritional support team (NST) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing chemoradiotherapy or radiotherapy.
METHODS


This study investigated whether early nutritional interventions by a multidisciplinary NST improve body weight loss, mucositis, serum albumin level, and hospital length of stay.
RESULTS


Sixty-one patients with HNSCC were treated during the study, and 32 patients received NST intervention since admission. The median weight loss rates were 3.3% and 7.3% and grade 3 mucositis was observed in 25.0% and 70.0% of patients in the intervention and nonintervention groups, respectively. In the intervention group, serum albumin level through treatment increased and the hospital length of stay from the end of treatment was shortened.
CONCLUSION


Early nutritional intervention by a multidisciplinary NST improved body weight loss rate, mucositis, albumin level, and hospital length of stay, which might lead to better clinical outcomes.",2020,"Early nutritional intervention by a multidisciplinary NST improved body weight loss rate, mucositis, albumin level, and hospital length of stay, which might lead to better clinical outcomes.","['patients with head and neck cancer undergoing', 'Sixty-one patients with HNSCC', 'patients with head and neck squamous cell carcinoma (HNSCC) undergoing chemoradiotherapy or radiotherapy']","['early nutritional intervention', 'chemoradiotherapy or radiotherapy', 'NST intervention', 'early nutritional intervention by a nutritional support team (NST']","['body weight loss rate, mucositis, albumin level, and hospital length of stay', 'serum albumin level', 'median weight loss rates', 'hospital length of stay', 'body weight loss, mucositis, serum albumin level, and hospital length of stay', 'grade 3 mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",61.0,0.017387,"Early nutritional intervention by a multidisciplinary NST improved body weight loss rate, mucositis, albumin level, and hospital length of stay, which might lead to better clinical outcomes.","[{'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Kono', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Wakisaka', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kumai', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Hayashi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Komatsuda', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Department of Palliative Care, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hidekiyo', 'Initials': 'H', 'LastName': 'Yamaki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Katada', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Harabuchi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical University, Asahikawa, Japan.'}]",Head & neck,['10.1002/hed.26502']
2310,33015927,Psychoeducational intervention on burden and emotional well-being addressed to informal caregivers of people with dementia.,"BACKGROUND


In dementia it is necessary that a family member become an informal caregiver. This labour has social, physical and emotional repercussions on the caregiver's health. The objective was to assesses the impact of the INFOSA-DEM intervention on burden and emotional well-being among caregivers of people with dementia, evaluating the effects at 3 and 6 months.
METHOD


We adopted an experimental, non-randomised design with an intervention group and a control group. The intervention group received the intervention and the control group received usual care. The study was carried out in the catchment areas of three centres specialising in the care of people with cognitive impairment in the province of Barcelona.
RESULTS


At 3 months, there was an improvement with respect to burden in the intervention group with a significant worsening (P < 0.012) in the control group. Similarly, a positive effect on emotional well-being was observed in the intervention group compared with a small negative effect among controls.
CONCLUSIONS


Programs addressed to informal caregivers based on psychoeducational and cognitive-behavioural therapies are effective in improving quality of life and emotional well-being, and in reducing burden, with a positive effect on the quality of care provided at home.",2020,"At 3 months, there was an improvement with respect to burden in the intervention group with a significant worsening (P < 0.012) in the control group.","['catchment areas of three centres specialising in the care of people with cognitive impairment in the province of Barcelona', 'informal caregivers of people with dementia']","['intervention and the control group received usual care', 'INFOSA-DEM intervention', 'Psychoeducational intervention']",[],"[{'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}]",[],,0.0407897,"At 3 months, there was an improvement with respect to burden in the intervention group with a significant worsening (P < 0.012) in the control group.","[{'ForeName': 'Cindy E', 'Initials': 'CE', 'LastName': 'Frias', 'Affiliation': 'Department of Nursing, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Risco', 'Affiliation': 'Hospital Pere I Virgili of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Zabalegui', 'Affiliation': 'Department of Nursing, Hospital Clinic of Barcelona, Barcelona, Spain.'}]",Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society,['10.1111/psyg.12616']
2311,33016036,The role of Protopine associated with Nuciferine in controlling adverse events during hyperthermic intravesical chemotherapy instillations. A nutraceutical approach to control adverse event during intravesical instillations.,"OBJECTIVES


The aim of this study was to analyse the role of two alkaloid, Protopine and Nuciferine, in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® (Hyperthermic IntraVEsical Chemotherapy) instillations.
MATERIALS AND METHODS


From September 2017 to September 2019, 100 patients were prospectively randomized into two groups: Group A = Protopine and Nuciferine syrup, 10 ml, once a day, for 8 weeks; Group B = placebo (flavoured coloured water), 10 ml, once a day, for 8 weeks. The primary endpoint was the evaluation of the efficacy of the therapy with Protopine and Nuciferine in controlling of the irritative symptoms. The secondary endpoint was the evaluation of the influences of the treatment on the uroflowmetric parameters.
RESULTS


The patients of Group A showed a better International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score). The treatment doesn't modify Uroflow-Qmax and seems to improve the Uroflow-Voided Volume (ml) without influencing the Uroflow-Post Void Residual volume (PVR). Moreover, the treatment with Protopine and Nuciferine has been proven to be effective in the treatment of overactive bladder (OAB) symptoms. Patients' evaluation of the two different treatments assessed with Patient Global Impression of Improvement questionnaire (PGI-I), demonstrated improvements in the Group A, while the Group B showed a lower satisfaction.
CONCLUSIONS


Protopine and Nuciferine can be interesting nutraceutical compounds useful to control irritative and pain related symptoms of intravesical chemo/immunotherapy.",2020,"The patients of Group A showed a better International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score).","['From September 2017 to September 2019, 100 patients']","['Nuciferine', 'HIVEC® (Hyperthermic IntraVEsical Chemotherapy) instillations', 'alkaloid, Protopine and Nuciferine', 'placebo', 'Protopine and Nuciferine', 'Protopine and Nuciferine syrup']","['evaluation of the efficacy of the therapy with Protopine and Nuciferine in controlling of the irritative symptoms', 'uroflowmetric parameters', 'International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score', 'Patient Global Impression of Improvement questionnaire (PGI-I']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0069113', 'cui_str': 'nuciferine'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0072495', 'cui_str': 'Protopine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0072495', 'cui_str': 'Protopine'}, {'cui': 'C0069113', 'cui_str': 'nuciferine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",100.0,0.035441,"The patients of Group A showed a better International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Chiancone', 'Affiliation': 'Department of Urology, A. Cardarelli Hospital, Naples. francescok86@gmail.com.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Carrino', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fedelini', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fabiano', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Persico', 'Affiliation': ''}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Meccariello', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fedelini', 'Affiliation': ''}]","Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica",['10.4081/aiua.2020.3.177']
2312,33016132,Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial.,"OBJECTIVE


To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF).
DESIGN


Multicentre, assessor-blinded, randomised controlled prospective trial.
SETTING


Three different rehabilitation hospitals in Germany.
SUBJECTS


In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group  n  = 23; control group  n  = 25).
INTERVENTION


The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO ® -Spring.
MAIN MEASURES


Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery.
RESULTS


The mean age of participants was 55 ± 10 years and was similar in both groups ( p  > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was -15 (CI = 8-22), at follow-up six month -7 (CI = -2 to 16) at follow up 13 month -9 (CI = 1-16); in control group -14 (CI = 11-18), at follow-up six month -13 (CI = 7-19) at follow up 13 month -6 (CI = -3 to 14). No difference in the change was found between groups ( p  > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy.
CONCLUSION


The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.",2020,"The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.","['Three different rehabilitation hospitals in Germany', 'In total 928 PHF patients between 35 and 70\u2009years were screened', 'after proximal humeral fracture', 'Forty-eight participants were included in the study (intervention group  n \u2009=\u200923', 'proximal humeral fractures (PHF']","['robotic-assisted training', 'control group  n \u2009=\u200925', 'usual occupational and physiotherapy', 'additional 12 robot-assisted training sessions at the ARMEO ® -Spring', 'Robot-assisted training']","['Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength', 'functional shoulder outcome']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441848', 'cui_str': 'Group N'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",928.0,0.048502,"The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Kröger', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Nerz', 'Affiliation': 'Department for Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwickert', 'Affiliation': 'Department for Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schölch', 'Affiliation': 'Department for Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Janina Anna', 'Initials': 'JA', 'LastName': 'Müßig', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Studier-Fischer', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Philip-Christian', 'Initials': 'PC', 'LastName': 'Nolte', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department for Clinical Gerontology, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Augat', 'Affiliation': 'Institute for Biomechanics, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany.'}]",Clinical rehabilitation,['10.1177/0269215520961654']
2313,33016149,Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial.,"OBJECTIVE


This study aimed to investigate the safety and efficacy of Xiangshao granules for treating emotional disorders in perimenopausal and postmenopausal women.
METHODS


The current investigation was a double-blind, randomized, placebo-controlled, multicenter trial that included 300 perimenopausal and postmenopausal Chinese women aged 40-60 years. Participants received either a placebo ( n  = 150) or Xiangshao granules ( n  = 150) for 8 weeks. Outcome measures included Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) scores, which were assessed at baseline, 4 weeks, and 8 weeks. The primary efficacy variables were changes in HAMD and HAMA scores after 8 weeks.
RESULTS


After 8 weeks, the mean HAMD scores decreased from 15.0 to 7.9 in the Xiangshao group and from 16.3 to 10.0 in the placebo group, and the respective mean reductions in HAMA scores were from 16.0 to 8.5 and from 17.1 to 10.9. Clinical improvements in symptoms of both depression and anxiety after 8 weeks differed significantly in the two groups ( p  < 0.05). The cure rate was significantly higher in the Xiangshao group. There were no significant differences in the rates of adverse events in the two groups.
CONCLUSIONS


Xiangshao granules can relieve symptoms of depression and anxiety significantly and safely.",2020,Clinical improvements in symptoms of both depression and anxiety after 8 weeks differed significantly in the two groups ( p  < 0.05).,"['perimenopausal and postmenopausal women', 'menopausal women', '300 perimenopausal and postmenopausal Chinese women aged 40-60\u2009years']","['placebo', 'Xiangshao granules']","['symptoms of both depression and anxiety', 'Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) scores', 'safety and efficacy', 'cure rate', 'mean HAMD scores', 'HAMA scores', 'rates of adverse events', 'emotional symptoms', 'HAMD and HAMA scores']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1291910', 'cui_str': 'Human anti-mouse antibody'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.325882,Clinical improvements in symptoms of both depression and anxiety after 8 weeks differed significantly in the two groups ( p  < 0.05).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Langfang Hospital of Traditional Chinese Medicine, Langfang, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Chengdu, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Obstetrics and Gynecology, 2nd Affliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Women and Children's Hospital, School of Medicine, Xiamen University, Xiamen, China.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': ""Department of Obstetrics and Gynecology, First-Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Obstetrics and Gynecology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Obstetrics and Gynecology, Chongqing University Affiliated Three Gorges Hospital, Chongqing, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1820476']
2314,33016169,Atraumatic Restorative Treatments in Australian Aboriginal Communities: A Cluster-randomized Trial.,"INTRODUCTION


The management of early childhood caries (ECC) is challenging.
OBJECTIVES


A model of care based on Atraumatic Restorative Treatment and the Hall Technique (ART-HT) to manage ECC was evaluated among remote Aboriginal communities in Australia.
METHODS


Aboriginal communities in the North-West of Western Australia were invited to participate and consenting communities were randomized into early or delayed intervention for the management of ECC. Children were examined at baseline and at the 11-mo follow-up. The early intervention group (test) was provided with the ART-based dental care at baseline while the delayed intervention group (control) was advised to seek care through the usual care options available within the community. At follow-up, both groups were examined by calibrated examiners, and were offered care using the ART-HT approach. Changes from baseline to follow-up in caries experience were tested using paired tests. Multivariate analysis after multiple imputation of missing data used generalised estimating equation (GEE) controlling for clustering within communities.
RESULTS


A total of 25 communities and 338 children (mean age = 3.6 y, SD 1.7) participated in the study (test = 177). At follow-up, 231 children were examined (68% retention, test = 125). At follow-up, children in the test group had more filled teeth (test filled teeth = 1.2, control filled teeth = 0.2, P < 0.001) and decreased levels of decayed teeth (mean test = 0.7 fewer teeth with decay, mean control = 1.0 more tooth with decay, P < 0.001). GEE analysis controlled for baseline caries experience, age, sex, and community water fluoride levels found increased rates of untreated decayed teeth (RR = 1.4, P = 0.02) and decreased rates of filled teeth (RR = 0.2, P < 0.001) at follow-up among the control group.
CONCLUSION


A model of care relying on the principles of minimally invasive atraumatic approaches enabled the delivery of effective dental services to young children (<6 y) in remote Aboriginal Australian communities resulting in increased levels of care and improved oral health.
KNOWLEDGE TRANSFER STATEMENT


This cluster-randomized trial tested a multi-component model of dental care to young children with ECC in remote Aboriginal communities in Australia. The intervention, based on the atraumatic approaches using minimally invasive techniques encompassing preventive care, Atraumatic Restorative Treatment and the Hall Technique (ART-HT), delivered more restorative care and reduced the incidence of caries. This model of care was more effective than available standard care and should be incorporated into mainstream service delivery programs.",2020,"A model of care relying on the principles of minimally invasive atraumatic approaches enabled the delivery of effective dental services to young children (<6 y) in remote Aboriginal Australian communities resulting in increased levels of care and improved oral health.
","['young children with ECC in remote Aboriginal communities in Australia', 'young children (<6 y) in remote Aboriginal Australian communities', 'Australian Aboriginal Communities', 'Aboriginal communities in the North-West of Western Australia were invited to participate and consenting communities', 'A total of 25 communities and 338 children (mean age = 3.6 y, SD 1.7) participated in the study (test = 177', 'remote Aboriginal communities in Australia']","['Atraumatic Restorative Treatments', 'ART-based dental care at baseline while the delayed intervention group (control) was advised to seek care through the usual care options available within the community', 'atraumatic approaches using minimally invasive techniques encompassing preventive care, Atraumatic Restorative Treatment and the Hall Technique (ART-HT', 'Atraumatic Restorative Treatment and the Hall Technique (ART-HT', 'delayed intervention for the management of ECC']","['levels of decayed teeth', 'filled teeth', 'levels of care and improved oral health', 'rates of filled teeth']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",231.0,0.0250107,"A model of care relying on the principles of minimally invasive atraumatic approaches enabled the delivery of effective dental services to young children (<6 y) in remote Aboriginal Australian communities resulting in increased levels of care and improved oral health.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piggott', 'Affiliation': 'Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': 'Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McPhee', 'Affiliation': 'Kimberley Aboriginal Medical Services, Broome, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Atkinson', 'Affiliation': 'Rural Clinical School of Western Australia, University of Western Australia, Broome, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mackean', 'Affiliation': 'Southgate Institute for Health, Society and Equity, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kularatna', 'Affiliation': 'Australian Centre for Health Services Innovation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Tonmukayakul', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': 'Health Department Western Australia, Office of Chief Dental Officer, Perth, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Community Development, Community Development, Murdoch University, Perth, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, South Australia, Australia.'}]",JDR clinical and translational research,['10.1177/2380084420963949']
2315,33016193,Time to First Culture Positivity for Gram-Negative Rods Resistant to Ceftriaxone in Critically Ill Adults.,"BACKGROUND


The optimal timing for the de-escalation of broad-spectrum antibiotics with activity against  Pseudomonas aeruginosa  and resistant Gram-negative rods (GNRs) in critically ill adults remains unknown.
RESEARCH QUESTION


We tested the hypothesis that cultures will identify GNRs that ultimately demonstrate resistance to ceftriaxone within 48 hours, potentially allowing safe de-escalation at this time point.
STUDY DESIGN AND METHODS


We conducted a secondary analysis of data from the Isotonic Solutions and Major Adverse Renal Events Trial: a pragmatic, cluster-randomized, multiple-crossover trial comparing balanced crystalloids versus saline for intravenous fluid administration in 15,802 critically ill adults at 5 intensive care units (ICUs) at Vanderbilt University Medical Center in Nashville, TN, USA. The primary endpoint was the time-to-positivity of respiratory and blood cultures that ultimately demonstrated growth of GNRs resistant to ceftriaxone. Multivariable logistic regression modeling was used to examine risk factors for the growth of cultures after 48 hours.
RESULTS


A total of 524 respiratory cultures had growth of GNRs, of which 284 (54.2%) had resistance to ceftriaxone. A total of 376 blood cultures grew GNRs, of which 70 (18.6%) had resistance to ceftriaxone. At 48 hours, 87% of respiratory cultures and 85% of blood cultures that ultimately grew GNRs resistant to ceftriaxone had demonstrated growth. Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
INTERPRETATION


Among a cohort of critically ill adults, 13% of respiratory cultures and 15% of blood cultures that ultimately grew GNRs resistant to ceftriaxone did not demonstrate growth until at least 48 hours after collection. Further work is needed to determine the ideal time for critically ill adults to de-escalate from broad-spectrum antibiotics targeting  Pseudomonas aeruginosa  and extended-spectrum β-lactamase-producing gram-negative pathogens.",2020,"Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
","['15,802 critically ill adults at 5 intensive care units (ICUs) at Vanderbilt University Medical Center in Nashville, TN, USA', 'Critically Ill Adults', 'critically ill adults']","['balanced crystalloids versus saline', 'ceftriaxone', 'Ceftriaxone']","['growth of GNRs', 'resistance to ceftriaxone', 'time-to-positivity of respiratory and blood cultures']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}]",15802.0,0.146295,"Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
","[{'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Buell', 'Affiliation': 'Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noto', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of intensive care medicine,['10.1177/0885066620963903']
2316,33016219,The Effect of Perceived Social Support on Personal Resources Following Minor Adversity: An Experimental Investigation of Belonging Affirmation.,"People rely on their social relationships to help them cope with many stressors over the course of their lives. Across three experiments, we randomly assigned people to experience minor adversity or not and then to experience perceived social support (via belonging affirmation) or not. We found that those who underwent adversity without perceived social support had lower scores on personal resources (e.g., gratitude, connectedness) than the other conditions. In addition, we tested whether perceived social support helps people grow following adversity or simply buffers them from adversity-related declines in personal resources. Our findings comparing growth and buffering hypotheses were mixed; however, the evidence for buffering was slightly stronger than the evidence for growth. Thus, more research is needed to determine whether perceived social support buffers decrements in personal resources following adversity or actually promotes growth. Nevertheless, perceived social support is an important source of resilience when facing life's inevitable challenges.",2020,"We found that those who underwent adversity without perceived social support had lower scores on personal resources (e.g., gratitude, connectedness) than the other conditions.",['Personal Resources Following Minor Adversity'],"['Perceived Social Support', 'experience minor adversity or not and then to experience perceived social support (via belonging affirmation) or not']",[],"[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",[],,0.0219387,"We found that those who underwent adversity without perceived social support had lower scores on personal resources (e.g., gratitude, connectedness) than the other conditions.","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Layous', 'Affiliation': 'California State University, East Bay, Hayward, USA.'}, {'ForeName': 'S Katherine', 'Initials': 'SK', 'LastName': 'Nelson-Coffey', 'Affiliation': 'Sewanee: The University of the South, TN, USA.'}]",Personality & social psychology bulletin,['10.1177/0146167220961270']
2317,33016306,Baseline Drinking Patterns in Non-Treatment Seeking Problem Drinkers.,"AIMS


Natural processes of change have been documented in treatment-seekers who begin to reduce their drinking in anticipation of treatment. The study examined whether non-treatment-seeking problem drinkers would engage in drinking reduction in anticipation of participating in a research study.
METHODS


Non-treatment-seeking problem drinkers (n = 935) were culled from five behavioral pharmacology studies. Participants reported on their alcohol use during the past 30 days using the Timeline Followback. Cluster analysis identified distinct groups/clusters based on drinking patterns over the 30-day pre-visit period. The identified clusters were compared on demographic and clinical measures.
RESULTS


Three distinct clusters were identified (a) heavy-decreasing drinking group (n = 255, 27.27%); (b) a moderate-stable drinking group (n = 353, 37.75%) and (c) low-stable drinking group (n = 327, 34.97%). The three clusters differed significantly on a host of measures including pre-visit drinking (age at first drink, drinking days, drinks per week, drinks per drinking day), alcohol use severity, alcohol craving, readiness for change, depression and anxiety levels. These differences were alcohol dose-dependent such that the heavier drinking group reported the highest levels on all constructs, followed by the moderate group, and the low drinking group last.
CONCLUSIONS


Baseline drinking patterns of non-treatment-seekers were generally stable and pre-visit reductions were only observed among the heavy drinking group. This generally stable pattern stands in contrast to previous reports for treatment-seeking samples. Nevertheless, the heavier drinking group, which is most similar to treatment-seekers, displayed pre-study drinking reduction. Overall, naturalistic processes of change may pose less of a threat to randomization and testing in this population.",2020,"The three clusters differed significantly on a host of measures including pre-visit drinking (age at first drink, drinking days, drinks per week, drinks per drinking day), alcohol use severity, alcohol craving, readiness for change, depression and anxiety levels.","['Non-treatment-seeking problem drinkers (n\xa0', 'Baseline Drinking Patterns in Non-Treatment Seeking Problem Drinkers']",['non-treatment-seeking problem drinkers'],"['pre-visit drinking (age at first drink, drinking days, drinks per week, drinks per drinking day), alcohol use severity, alcohol craving, readiness for change, depression and anxiety levels']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",935.0,0.0120625,"The three clusters differed significantly on a host of measures including pre-visit drinking (age at first drink, drinking days, drinks per week, drinks per drinking day), alcohol use severity, alcohol craving, readiness for change, depression and anxiety levels.","[{'ForeName': 'Wave-Ananda', 'Initials': 'WA', 'LastName': 'Baskerville', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Nieto', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Towns', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Caesar', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Donato', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa098']
2318,33016332,Author response to: Comment on: Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,,2020,,[],['laparoscopic umbilical hernia repair'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia'}]",[],,0.239003,,"[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Christoffersen', 'Affiliation': ''}, {'ForeName': 'Thue', 'Initials': 'T', 'LastName': 'Bisgaard', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.12019']
2319,33016374,Rivastigmine in Parkinson's Disease Dementia with Orthostatic Hypotension.,"OBJECTIVE


To evaluate if the cognitive benefit of rivastigmine is affected by the presence of orthostatic hypotension (OH) in patients with Parkinson's disease dementia (PDD).
METHODS


We conducted a post-hoc analysis on 1,047 PDD patients from two randomized controlled trials comparing rivastigmine vs. placebo at week 24 (n = 501) and rivastigmine patch vs. capsule at week 76 (n = 546). A drop ≥20 mm Hg in systolic or ≥ 10 in diastolic blood pressure upon standing classified subjects as OH+; otherwise, OH-. The primary endpoint was the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) at week 24 and the Mattis Dementia Rating Scale (MDRS) at week 76, using intention-to-treat with retrieved dropout at week 24 and observed cases, at week 76, consistent with the original analyses.
RESULTS


Overall safety was comparable between OH+ (n = 288, 27.5%) and OH- (n = 730, 69.7%), except for higher frequency of syncope (9.2%) in the OH+ placebo arm. The placebo-adjusted effect of rivastigmine on ADAS-Cog at week 24 was 5.6 ± 1.2 for OH+ and 1.9 ± 0.9 in OH- (p = 0.0165). Among OH+ subjects, the MDRS change from baseline at week 76 was higher for rivastigmine capsules vs. patch (10.6 ± 2.9 vs. -1.5 ± 3.0) (p = 0.031). The overall prevalence of OH+ was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%) (p = 0.0476).
INTERPRETATION


The cognitive benefit from rivastigmine is larger in PDD patients with OH, possibly mediated by a direct antihypotensive effect. This article is protected by copyright. All rights reserved.",2020,"The overall prevalence of OH+ was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%) (p = 0.0476).
","['PDD patients with OH', ""patients with Parkinson's disease dementia (PDD"", '1,047 PDD patients', ""Parkinson's Disease Dementia with Orthostatic Hypotension""]","['rivastigmine patch vs. capsule', 'placebo', 'rivastigmine vs. placebo', 'rivastigmine', 'Rivastigmine']","['Overall safety', 'frequency of syncope', 'MDRS change', ""Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) at week 24 and the Mattis Dementia Rating Scale (MDRS"", 'orthostatic hypotension (OH', 'diastolic blood pressure', 'overall prevalence of OH']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}]","[{'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",1047.0,0.312229,"The overall prevalence of OH+ was lower for rivastigmine than placebo at week 24 (28.3% vs 44.6%) (p = 0.0476).
","[{'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""Gardner Family Center for Parkinson's disease and Movement Disorders, Cincinnati, Ohio, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marsili', 'Affiliation': ""Gardner Family Center for Parkinson's disease and Movement Disorders, Cincinnati, Ohio, USA.""}, {'ForeName': 'Abhimanyu', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Section of Movement Disorders, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sturchio', 'Affiliation': ""Gardner Family Center for Parkinson's disease and Movement Disorders, Cincinnati, Ohio, USA.""}, {'ForeName': 'Rashidkhan', 'Initials': 'R', 'LastName': 'Pathan', 'Affiliation': 'Princical Biostatistician, Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pilotto', 'Affiliation': ""Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, and Parkinson's Disease Rehabilitation Centre, FERB ONLUS - S. Isidoro Hospital, Trescore Balneario (BG), Italy.""}, {'ForeName': 'Damodaran Solai', 'Initials': 'DS', 'LastName': 'Elango', 'Affiliation': 'Associate Clinical Development Medical Director, Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pezous', 'Affiliation': 'Early Development Biostatistics, Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Masellis', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Baltazar', 'Initials': 'B', 'LastName': 'Gomez-Mancilla', 'Affiliation': 'Neuroscience Translational Medicine, Novartis Institutes for Biomedical Research, Adjunct Professor Neurology & Neurosurgery, McGill University, Montreal, Canada.'}]",Annals of neurology,['10.1002/ana.25923']
2320,33016505,Fibroblast growth factor 23 as a risk factor for cardiovascular events and mortality in patients in the EVOLVE trial.,"INTRODUCTION


High mortality rates in patients with chronic kidney disease-mineral and bone disorder (CKD-MBD) receiving maintenance hemodialysis are largely due to cardiovascular (CV) events.
METHODS


We evaluated associations between MBD parameters, fibroblast growth factor 23 (FGF23) concentrations, and clinically adjudicated CV events from the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. Patients enrolled in EVOLVE, who had not experienced any study endpoints between randomization and week 20 with evaluable baseline and week 20 values for key laboratory parameters (parathyroid hormone, calcium, phosphate, and FGF23), were assessed. We used adjusted Cox proportional hazards regression models to estimate relative risk of outcomes (primary composite, all-cause mortality, and CV events) based on FGF23 and MBD parameters. Laboratory values were modeled with linear terms and using natural cubic splines with two degrees of freedom.
FINDINGS


For the primary endpoint, patients assessed (N = 2309) were followed up over a mean duration of 3.1 years, during which 1037 CV events (497 deaths, 540 nonfatal events) occurred. Adjusted models showed an association between FGF23 and the risk of CV events. Hazard ratio per log unit of FGF23 at week 20 was 1.09 [95% CI: 1.03-1.16], and the hazard ratio per log unit change in FGF23 from week 0 to week 20 was 1.09 [95% CI: 1.00-1.17].
DISCUSSION


Our data highlight FGF23 as an independent CV risk factor and potential biomarker and therapeutic target for patients with CKD-MBD receiving maintenance hemodialysis.",2020,"Hazard ratio per log unit of FGF23 at week 20 was 1.09 [95% CI: 1.03-1.16], and the hazard ratio per log unit change in FGF23 from week 0 to week 20 was 1.09 [95% CI: 1.00-1.17].
","['patients with CKD-MBD receiving maintenance hemodialysis', 'patients with chronic kidney disease-mineral and bone disorder (CKD-MBD) receiving maintenance hemodialysis', 'patients in the EVOLVE trial', 'Patients enrolled in EVOLVE, who had not experienced any study endpoints between randomization and week 20 with evaluable baseline and week 20 values for key laboratory parameters (parathyroid hormone, calcium, phosphate, and FGF23), were assessed']",[],"['Hazard ratio per log unit of FGF23', 'MBD parameters, fibroblast growth factor 23 (FGF23) concentrations, and clinically adjudicated CV events', 'hazard ratio per log unit change in FGF23']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4076240', 'cui_str': 'Chronic kidney disease mineral and bone disorder'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1260199', 'cui_str': 'Cinacalcet hydrochloride'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0005944', 'cui_str': 'Metabolic bone disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",2309.0,0.0317926,"Hazard ratio per log unit of FGF23 at week 20 was 1.09 [95% CI: 1.03-1.16], and the hazard ratio per log unit change in FGF23 from week 0 to week 20 was 1.09 [95% CI: 1.00-1.17].
","[{'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'US Renal Care, Plano, Texas, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xing', 'Affiliation': 'Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fouqueray', 'Affiliation': 'Amgen Inc., Rotkreuz, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Halperin', 'Affiliation': 'Outcomes Insights, Inc., Agoura Hills, California, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Danese', 'Affiliation': 'Outcomes Insights, Inc., Agoura Hills, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12887']
2321,33016570,Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics.,"OBJECTIVES


To report the explantation rates of high frequency 10 kHz spinal cord stimulation (SCS) in a real-world setting.
MATERIALS AND METHODS


This is a retrospective review of patients implanted with high frequency spinal cord stimulators over a 4-year period in two outpatient private practice clinics, from July 2015 through June 2019, using the Kaplan-Meier product-limit method to estimate probabilities of implant survival over time.
RESULTS


The estimated median time to explantation in this study (95% confidence interval [CI] = 3.1-3.7). The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively. The minimum (i.e., known) cumulative percentages of patients explanted by 1, 2, and 3 years postimplantation were 11.1% (14/126), 22.2% (28/126), and 32.5% (41/126), respectively. 65.9% of patients in this study had prior neurostimulation.
CONCLUSIONS


Recently, high frequency SCS technology has been demonstrated as more effective in treatment of lower- and leg-pain, compared to conventional low frequency SCS, in a 12-month randomized controlled trial (SENZA-RCT). Longer term results have yet to be published. In this study, we found that the explantation rate was much higher than expected, based on the prior studies demonstrating its efficacy. As the use of neuromodulation continues to grow, longitudinal data will be critical in understanding its long-term effects on treated patients.",2020,"The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively.","['Two Outpatient Clinics', 'patients implanted with high frequency spinal cord stimulators over a 4-year period in two outpatient private practice clinics, from July 2015 through June 2019']",['kHz spinal cord stimulation (SCS'],"['estimated probabilities of implant survival', 'explantation rate', 'median time to explantation']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.120114,"The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively.","[{'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Bounkousohn', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Bernstein', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Paicius', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gilligan', 'Affiliation': ""Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.""}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13280']
2322,33016677,"[Efficacy and safety of mexidol across age groups in the acute and early recovery stages of hemispheric ischemic stroke (results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICA)].","AIM


To evaluate the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (IS) across age groups according to the World Health Organization classification.
MATERIAL AND METHODS


The study is an additional analysis across age groups among patients participated in the randomized double blind multicenter placebo-controlled, in parallel groups trial EPICA. All subjects (62 men and 88 women) were subdivided into age groups: younger than 60 years, 60-65 years, 76-90 years. Additionally, all participants were divided into 2 populations: ITT (Intent to treat population, patients who received at least one treatment/placebo dose) and PP (Per protocol population, patients who received treatment per study protocol). Results of Modified Rankin scale (mRs) at the end of treatment period, Barthel index, Beck depression inventory, European Quality of Life Questionnaire were assessed.
RESULTS


The efficacy of mexidol assessed with all the scales did not differ depending on the age group. By the end of treatment, the mean mRS score was lower in the 76-90 years subgroup (in both populations), compared to placebo ( p <0.001). The decrease in mean mRS score (Visit 1-5) was more prominent in patients aged 60-65 years ( p =0.025), including patients with diabetes mellitus (DM). Patients aged 76-90 years and patients with DM, compared to placebo, had a decrease of the severity of cognitive-affective depression symptoms ( p =0.049 and  p =0.02) and an increase in patients without problems with everyday activities ( p =0.007 and  p =0.02). Patients with DM, compared to placebo, also had the higher levels of everyday activity ( p =0.023) and quality of life ( p =0.045). There were no statistically significant differences in the frequency of side-effects in patients of all groups.
CONCLUSION


It is recommended to include mexidol in therapy of patients with IS in the acute and early rehabilitation stages in all age groups, including patients with DM.",2020,"Patients with DM, compared to placebo, also had the higher levels of everyday activity ( p =0.023) and quality of life ( p =0.045).","['patients with IS in the acute and early rehabilitation stages in all age groups, including patients with DM', 'All subjects (62 men and 88 women) were subdivided into age groups: younger than 60 years, 60-65 years, 76-90 years', 'Patients aged 76-90 years and patients with DM']","['placebo', 'placebo dose) and PP', 'mexidol']","['mean mRS score', 'efficacy and safety', 'hemispheric ischemic stroke', 'Barthel index, Beck depression inventory, European Quality of Life Questionnaire', 'severity of cognitive-affective depression symptoms', 'Modified Rankin scale (mRs', 'frequency of side-effects', 'patients without problems with everyday activities', 'quality of life', 'higher levels of everyday activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0128329', 'cui_str': 'mexidol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.356565,"Patients with DM, compared to placebo, also had the higher levels of everyday activity ( p =0.023) and quality of life ( p =0.045).","[{'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Stakhovskaya', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Mkhitaryan', 'Affiliation': 'Russian Clinical and Research Center of Gerontology of Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'O N', 'Initials': 'ON', 'LastName': 'Tkacheva', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Ostroumova', 'Affiliation': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical (Sechenov University), Moscow, Russia.'}, {'ForeName': 'O D', 'Initials': 'OD', 'LastName': 'Ostroumova', 'Affiliation': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical (Sechenov University), Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012008249']
2323,33016680,[Robotic recovery of walking function in patients in the early recovery period of stroke].,"OBJECTIVE


To compare the efficacy of walking function recovery in patients in the early recovery period of ischemic stroke (IS) using an exoskeleton for the lower extremities and an active-passive pedal exercise bike.
MATERIAL AND METHODS


An open randomized study of 47 patients in the early recovery period of IS was conducted. The rehabilitation course included exercises on an ExoAtlet exoskeleton in group 1 and exercises on a pedal simulator for active-passive training (5 days a week for 2 weeks) in group 2. Several tests were used to evaluate treatment results, including the Hauser walking index, the 10-meter walking test, the Berg balance scale, stabilometry, and biomechanics of walking. The complete training course was completed by 20 patients of group 1 and 21 of group 2.
RESULTS


There was a significant increase in strength in paretic muscles, postural stability, functional level and walking speed in patients of both groups, but in patients of group 1, the dynamics of recovery was more pronounced ( p <0.05). In group 1, there was a significant decrease in the level of disability and an increase in daily activity, which was higher compared to group 2. An analysis of the main indicators of the statokinesiogram showed the more pronounced positive shifts in patients of group 1, but significant differences were found only in the dynamics of the length and area of the curve in the test with eyes open. When studying the biomechanics of walking, it was found that the function of walking was changed: there was a significant decrease in the speed of movement by 2.2 times, the length of a double step by 1.6 times, and the pace of walking by 1.3 times compared to normal indicators. After the end of exercises, a significant increase in the length of the double step, speed and pace of walking as well as a decrease in the period of the locomotor cycle were found in group 1.
CONCLUSION


The study revealed a positive impact of hardware rehabilitation on locomotion, both with the use of an exoskeleton and an active-passive pedal simulator. The use of an exoskeleton, have the advantages resulting in a significantly greater recovery of strength, stability, speed and symmetry of walking over the same period of training. A significant increase in postural stability in vertical position was revealed.",2020,"There was a significant increase in strength in paretic muscles, postural stability, functional level and walking speed in patients of both groups, but in patients of group 1, the dynamics of recovery was more pronounced ( p <0.05).","['patients in the early recovery period of ischemic stroke (IS', 'patients in the early recovery period of stroke', '47 patients in the early recovery period of IS was conducted']","['exercises on an ExoAtlet exoskeleton in group 1 and exercises on a pedal simulator for active-passive training', 'hardware rehabilitation']","['daily activity', 'strength in paretic muscles, postural stability, functional level and walking speed', 'postural stability in vertical position', 'Hauser walking index, the 10-meter walking test, the Berg balance scale, stabilometry, and biomechanics of walking', 'strength, stability, speed and symmetry of walking', 'dynamics of recovery', 'level of disability', 'length of the double step, speed and pace of walking as well as a decrease in the period of the locomotor cycle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",47.0,0.0246276,"There was a significant increase in strength in paretic muscles, postural stability, functional level and walking speed in patients of both groups, but in patients of group 1, the dynamics of recovery was more pronounced ( p <0.05).","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Kotov', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Isakova', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Lijdvoy', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Petrushanskaya', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Pismennaya', 'Affiliation': 'Research Institute of Mechanics of Moscow State University, Moscow, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Romanova', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Kodzokova', 'Affiliation': 'Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012008273']
2324,33016783,"A Randomized, Double-blind, Parallel Pharmacokinetic Study Comparing the Trastuzumab Biosimilar Candidate, AryoTrust®, and Reference Trastuzumab in Healthy Subjects.","BACKGROUND


AryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®.
RESEARCH DESIGN AND METHODS;


In this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC 0-inf ), and the main secondary endpoints were maximum measured concentration (C max ), area under the concentration versus time from zero to the last quantifiable concentration time (AUC 0-last ), immunogenicity, and safety.
RESULTS


Sixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%-125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
CONCLUSION


AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed. Trial Registration The trial is registered at Indian Trials Registry (CTRI/2019/03/018218).",2020,"No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
","['Sixty subjects', '60 healthy male subjects', 'Healthy Subjects']","['Trastuzumab Biosimilar Candidate, AryoTrust®, and Reference Trastuzumab', 'AryoTrust® or Herceptin®']","['serious adverse event or immunogenicity', 'adverse events', 'area under the concentration versus time to infinity (AUC 0-inf ), and the main secondary endpoints were maximum measured concentration (C max ), area under the concentration versus time from zero to the last quantifiable concentration time (AUC 0-last ), immunogenicity, and safety']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0338204', 'cui_str': 'Herceptin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.452882,"No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farmahani Farahani', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Maghzi', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jafari Aryan', 'Affiliation': 'CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Payandemehr', 'Affiliation': 'Experimental Medicine Research Center, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Soni', 'Affiliation': 'Cliantha Research Limited , Ahmedabad-380 054, Gujarat, India.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Azhdarzadeh', 'Affiliation': 'Biopharmaceutical Research Center, AryoGen Pharmed Inc., Alborz University of Medical Sciences , Karaj, Iran.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1831470']
2325,33016883,Expanding Access to Perinatal Depression Treatment in Kenya Through Automated Psychological Support: Development and Usability Study.,"BACKGROUND


Depression during pregnancy and in the postpartum period is associated with poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings; however, there are significant barriers to scale-up. We address this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
OBJECTIVE


This prepilot study aims to gather preliminary data on the Healthy Moms perinatal depression intervention to learn how to build and test a more robust service.
METHODS


We conducted a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya. We invited these women to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants were randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. We prompted participants to rate their mood via SMS text messaging every 3 days during the baseline and intervention periods, and we used these preliminary repeated measures data to fit a linear mixed-effects model of response to treatment. We also reviewed system logs and conducted in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability.
RESULTS


We invited 647 women to learn more about Zuri: 86 completed our automated SMS screening and 41 enrolled in the study. Most of the enrolled women submitted at least 3 mood ratings (31/41, 76%) and sent at least 1 message to Zuri (27/41, 66%). A third of the sample engaged beyond registration (14/41, 34%). On average, women who engaged post registration started 3.4 (SD 3.2) Healthy Moms sessions and completed 3.1 (SD 2.9) of the sessions they started. Most interviewees who tried Zuri reported having a positive attitude toward the service and expressed trust in Zuri. They also attributed positive life changes to the intervention. We estimated that using this alpha version of Zuri may have led to a 7% improvement in mood.
CONCLUSIONS


Zuri is feasible to deliver via SMS and was acceptable to this sample of pregnant women and new mothers. The results of this prepilot study will serve as a baseline for future studies in terms of recruitment, data collection, and outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/11800.",2020,"This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
","['women and their children', 'women who engaged post registration started 3.4 (SD 3.2', '647 women to learn more about Zuri: 86 completed our automated SMS screening and 41 enrolled in the study', 'pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya', 'pregnant women and new mothers']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]",[],[],647.0,0.171359,"This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
","[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Green', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Yihuan', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Sathyanath', 'Initials': 'S', 'LastName': 'Rajasekharan', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rauws', 'Affiliation': 'X2AI, San Francisco, CA, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Joerin', 'Affiliation': 'X2AI, San Francisco, CA, United States.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kwobah', 'Affiliation': 'Moi Teaching and Referral Hospital, Eldoret, Kenya.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Musyimi', 'Affiliation': 'Africa Mental Health Research and Training Foundation, Nairobi, Kenya.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Chaya', 'Initials': 'C', 'LastName': 'Bhat', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Mulinge', 'Affiliation': 'Jacaranda Health, Nairobi, Kenya.'}, {'ForeName': 'Eve S', 'Initials': 'ES', 'LastName': 'Puffer', 'Affiliation': 'Duke Global Health Institute, Durham, NC, United States.'}]",JMIR formative research,['10.2196/17895']
2326,33016896,Improving motion detection via anodal transcranial direct current stimulation.,"BACKGROUND


To study motion perception, a stimulus consisting of a field of small, moving dots is often used. Generally, some of the dots coherently move in the same direction (signal) while the rest move randomly (noise). A percept of global coherent motion (CM) results when many different local motions are combined. CM computation is a complex process that requires the integrity of the middle-temporal area (MT/V5) and there is evidence that increasing the number of dots presented in the stimulus makes such computation more efficient.
OBJECTIVE


In this study, we explored whether anodal direct current stimulation (tDCS) over MT/V5 would increase individual performance in a CM task at a low signal-to-noise ratio (SNR, i.e. low percentage of coherent dots) and with a target consisting of a large number of moving dots (high dot numerosity, e.g. >250 dots) with respect to low dot numerosity (<60 dots), indicating that tDCS favour the integration of local motion signal into a single global percept (global motion).
METHOD


Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received anodal, cathodal, or sham stimulation on three different days.
RESULTS


Our findings showed no effect of cathodal tDCS with respect to the sham condition. Instead, anodal tDCS improves performance, but mostly when dot numerosity is high (>400 dots) to promote efficient global motion processing.
CONCLUSIONS


The present study suggests that tDCS may be used under appropriate stimulus conditions (low SNR and high dot numerosity) to boost the global motion processing efficiency, and may be useful to empower clinical protocols to treat visual deficits.",2020,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"['Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received']","['anodal direct current stimulation (tDCS) over MT/V5', 'anodal tDCS', 'tDCS', 'anodal, cathodal, or sham stimulation']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],,0.0409238,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Battaglini', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Mena', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Casco', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201050']
2327,33016931,Working Memory Training for Older Participants: A Control Group Training Regimen and Initial Intellectual Functioning Assessment.,"The efficacy of cognitive training interventions is recently highly debated. There is no consensus on what kind of training regimen is the most effective. Also, individual characteristics as predictors of training outcome are still being investigated. In this article, we show the attempt to address this issue by examining not only the impact of working memory (WM) training on cognitive effectiveness in older adults but also the influence of the initial WM capacity (WMC) on the training's outcome. We describe in detail how to perform 5 weeks of an adaptive dual n-back training with an active control group (memory quiz). We are focusing here on technical aspects of the training as well as on the initial assessment of participants' WMC. The evaluation of pre and post training performance of other cognitive dimensions was based on the results of tests of memory updating, inhibition, attention shifting, short-term memory (STM) and reasoning. We have found that the initial level of WMC predicts the efficiency of the n-back training intervention. We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.",2020,"We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.","['older adults', 'Older Participants']","['adaptive dual n-back training with an active control group (memory quiz', 'cognitive training interventions', 'Working Memory Training', 'working memory (WM) training']","['cognitive effectiveness', 'memory updating, inhibition, attention shifting, short-term memory (STM) and reasoning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.0159781,"We have also noticed the post training improvement in almost all aspects of cognitive functioning we measured, but those effects were mostly intervention independent.","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Matysiak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Zarzycka', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Bramorska', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Brzezicka', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities; Department of Neurosurgery, Cedars-Sinai Medical Center; abrzezi2@swps.edu.pl.'}]",Journal of visualized experiments : JoVE,['10.3791/60804']
2328,33016987,Effectiveness of a Home- and School-Based Asthma Educational Program for Head Start Children With Asthma: A Randomized Clinical Trial.,"Importance


Asthma is the most common chronic childhood disease, with Black children experiencing worse morbidity and mortality. It is important to evaluate the effectiveness of efficacious interventions in community settings that have the greatest likelihood of serving at-risk families.
Objective


To evaluate the effectiveness of a multilevel home- and school (Head Start)-based asthma educational program compared with a Head Start-based asthma educational program alone in improving asthma outcomes in children.
Design, Setting, and Participant


This randomized clinical trial included 398 children with asthma enrolled in Head Start preschool programs in Baltimore, Maryland, and their primary caregivers. Participants were recruited from April 1, 2011, to November 31, 2016, with final data collection ending December 31, 2017. Data were analyzed from March 18 to August 30, 2018.
Interventions


Asthma Basic Care (ABC) family education combined with Head Start asthma education compared with Head Start asthma education alone.
Main Outcomes and Measures


Asthma control as measured by the Test for Respiratory and Asthma Control in Kids (TRACK) score.
Results


Among the 398 children included in the analysis (247 boys [62.1%]; mean [SD] age, 4.2 [0.7] years), the ABC plus Head Start program improved asthma control (β = 6.26; 95% CI, 1.77 to 10.75; P < .001), reduced courses of oral corticosteroids (β = -0.61; 95% CI, -1.13 to -0.09; P = .02), and reduced hospitalizations (odds ratio, 0.36; 95% CI, 0.21-0.61; P < .001) during a 12-month period.
Conclusion and Relevance


In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations. Multilevel interventions implemented in community settings that serve low-income minority families may be key to reducing disparities in asthma outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01519453.",2020,"In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations.","['Participants were recruited from April 1, 2011, to November 31, 2016, with final data collection ending December 31, 2017', 'With Asthma', 'Head Start Children', '398 children with asthma enrolled in Head Start preschool programs in Baltimore, Maryland, and their primary caregivers', '398 children included in the analysis (247 boys [62.1%]; mean [SD] age, 4.2 [0.7] years', 'children']","['multilevel home- and school (Head Start)-based asthma educational program compared with a Head Start-based asthma educational program alone', 'combined family and preschool asthma educational interventions', 'Interventions\n\n\nAsthma Basic Care (ABC) family education combined with Head Start asthma education compared with Head Start asthma education alone', 'Home- and School-Based Asthma Educational Program']","['reduced hospitalizations', 'Main Outcomes and Measures\n\n\nAsthma control as measured by the Test for Respiratory and Asthma Control in Kids (TRACK) score', 'reduced courses of oral corticosteroids']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",398.0,0.0679052,"In this randomized clinical trial, combined family and preschool asthma educational interventions improved asthma control and reduced courses of oral corticosteroids and hospitalizations.","[{'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Zaeh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eckmann', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ruvalcaba', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Rand', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marisa E', 'Initials': 'ME', 'LastName': 'Hilliard', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston.""}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Riekert', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.3375']
2329,33016996,"Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.","Importance


In-hospital administration of tranexamic acid after injury improves outcomes in patients at risk for hemorrhage. Data demonstrating the benefit and safety of the pragmatic use of tranexamic acid in the prehospital phase of care are lacking for these patients.
Objective


To assess the effectiveness and safety of tranexamic acid administered before hospitalization compared with placebo in injured patients at risk for hemorrhage.
Design, Setting, and Participants


This pragmatic, phase 3, multicenter, double-blind, placebo-controlled, superiority randomized clinical trial included injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019.
Interventions


Patients received 1 g of tranexamic acid before hospitalization (447 patients) or placebo (456 patients) infused for 10 minutes in 100 mL of saline. The randomization scheme used prehospital and in-hospital phase assignments, and patients administered tranexamic acid were allocated to abbreviated, standard, and repeat bolus dosing regimens on trauma center arrival.
Main Outcomes and Measures


The primary outcome was 30-day all-cause mortality.
Results


In all, 927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to tranexamic acid intervention; 467 to placebo intervention). After exclusions, the intention-to-treat study cohort comprised 903 patients: 447 in the tranexamic acid arm and 456 in the placebo arm. Mortality at 30 days was 8.1% in patients receiving tranexamic acid compared with 9.9% in patients receiving placebo (difference, -1.8%; 95% CI, -5.6% to 1.9%; P = .17). Results of Cox proportional hazards regression analysis, accounting for site, verified that randomization to tranexamic acid was not associated with a significant reduction in 30-day mortality (hazard ratio, 0.81; 95% CI, 0.59-1.11, P = .18). Prespecified dosing regimens and post-hoc subgroup analyses found that prehospital tranexamic acid were associated with significantly lower 30-day mortality. When comparing tranexamic acid effect stratified by time to treatment and qualifying shock severity in a post hoc comparison, 30-day mortality was lower when tranexamic acid was administered within 1 hour of injury (4.6% vs 7.6%; difference, -3.0%; 95% CI, -5.7% to -0.3%; P < .002). Patients with severe shock (systolic blood pressure ≤70 mm Hg) who received tranexamic acid demonstrated lower 30-day mortality compared with placebo (18.5% vs 35.5%; difference, -17%; 95% CI, -25.8% to -8.1%; P < .003).
Conclusions and Relevance


In injured patients at risk for hemorrhage, tranexamic acid administered before hospitalization did not result in significantly lower 30-day mortality. The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events. Tranexamic acid given to injured patients at risk for hemorrhage in the prehospital setting is safe and associated with survival benefit in specific subgroups of patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02086500.",2020,The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events.,"['927 patients (mean [SD] age, 42 [18] years; 686 [74.0%] male) were eligible for prehospital enrollment (460 randomized to', 'injured patients with prehospital hypotension (systolic blood pressure ≤90 mm Hg) or tachycardia (heart rate ≥110/min) before arrival at 1 of 4 US level 1 trauma centers, within an estimated 2 hours of injury, from May 1, 2015, through October 31, 2019', 'arm and 456 in the placebo arm', '903 patients: 447 in the', 'patients at risk for hemorrhage', 'Patients at Risk for Hemorrhage', 'Patients with severe shock (systolic blood pressure ≤70 mm Hg', 'injured patients at risk for hemorrhage']","['tranexamic acid intervention; 467 to placebo', 'Tranexamic Acid', 'tranexamic acid', 'placebo (456 patients) infused for 10 minutes in 100 mL of saline', 'placebo', 'Placebo', 'prehospital tranexamic acid', 'Tranexamic acid']","['30-day mortality', 'Mortality', '30-day all-cause mortality', 'thrombotic complications or adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.772109,The prehospital administration of tranexamic acid after injury did not result in a higher incidence of thrombotic complications or adverse events.,"[{'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mazen S', 'Initials': 'MS', 'LastName': 'Zenati', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Early-Young', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Adams', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Eastridge', 'Affiliation': 'Department of Surgery, University of Texas Health San Antonio, San Antonio.'}, {'ForeName': 'Raminder', 'Initials': 'R', 'LastName': 'Nirula', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Vercruysse', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': ""O'Keeffe"", 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Bellal', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson.'}, {'ForeName': 'Louis H', 'Initials': 'LH', 'LastName': 'Alarcon', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Forsythe', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Billiar', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Peitzman', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, Pittsburgh Trauma Research Center, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.4350']
2330,33017045,"A split face randomized controlled trial comparing 1,064 nm Q-switched Nd-YAG laser and modified Kligman's formulation in patients with melasma in darker skin.","BACKGROUND


No randomized studies compared the efficacy and safety of modified Kligman's triple combination (TC) with 1,064 nm Q-switched Nd-YAG laser (QSNYL) in melasma in darker skin.
OBJECTIVES


To compare the efficacy and safety of QSNYL and TC in the treatment of melasma in Fitzpatrick skin types IV and V.
METHODS


In this split face randomized controlled trial, participants' cheeks were randomized to receive either weekly QSNYL (group A) or daily TC (group B) for 12 weeks, followed by 12 weeks of follow-up.
RESULTS


Twenty-eight patients completed the intervention, and 21 of them completed follow-up. We found a significant but modest reduction in mean melanin index, modified Melasma Area Severity Index (MASI), and photographic and patient's assessment in both modalities (P < 0.01). No significant differences were detected between the groups. All patients had reappearance of pigmentation by the end of follow-up. Adverse reactions were significantly more in group B (P < 0.001).
LIMITATION


The desired sample size could not be achieved.
CONCLUSION AND RELEVENCE


No statistically significant differences were observed between QSNYL and TC as monotherapy in melasma. Reappearance of melasma is inevitable after stopping treatment.",2020,"Adverse reactions were significantly more in group B (P < 0.001).
","[""participants' cheeks"", 'melasma in Fitzpatrick skin types', 'melasma in darker skin', 'patients with melasma in darker skin']","[""1,064\xa0nm Q-switched Nd-YAG laser and modified Kligman's formulation"", 'QSNYL and TC', 'daily TC', ""modified Kligman's triple combination (TC) with 1,064\xa0nm Q-switched Nd-YAG laser (QSNYL""]","['efficacy and safety', 'reappearance of pigmentation', 'Adverse reactions', ""mean melanin index, modified Melasma Area Severity Index (MASI), and photographic and patient's assessment in both modalities (P""]","[{'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.057856,"Adverse reactions were significantly more in group B (P < 0.001).
","[{'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Dev', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Sahni', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Bhari', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gomathy', 'Initials': 'G', 'LastName': 'Sethuraman', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}]",International journal of dermatology,['10.1111/ijd.15229']
2331,33017047,"Low dose ketamine reduces pain perception and blood pressure, but not muscle sympathetic nerve activity, responses during a cold pressor test.","KEY POINTS


Low dose ketamine is a leading medication used to provide analgesia in pre-hospital and hospital settings. Low dose ketamine is increasingly used off-label to treat conditions such as depression. In animals, ketamine stimulates the sympathetic nervous system and increases blood pressure, but these physiological consequences have not been studied in conscious humans. Our data suggest that low dose ketamine administration blunts pain perception and reduces blood pressure, but not muscle sympathetic nerve activity burst frequency, responses during a cold pressor test in healthy humans. These mechanistic, physiological results inform risk-benefit analysis for clinicians administering low dose ketamine in humans.
ABSTRACT


Low dose ketamine is an effective analgesic medication. However, our knowledge of the effects of ketamine on autonomic cardiovascular regulation is primarily limited to animal experiments. Notably, it is unknown if low dose ketamine influences autonomic cardiovascular responses during painful stimuli in humans. We tested the hypothesis that low dose ketamine blunts perceived pain, and blunts subsequent sympathetic and cardiovascular responses during an experimental noxious stimulus. Twenty-two adults (10F/12M; 27±6 y; 26±3 kg m -2  , mean±SD) completed this randomized, crossover, placebo-controlled trial during two laboratory visits. During each visit, participants completed cold pressor tests (CPT; hand in ∼0.4°C ice bath for two minutes) pre- and five minutes post-drug administration (20 mg ketamine or saline). We compared pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings) and beat-to-beat blood pressure (BP; photoplethysmography) during the pre- and post-drug CPT's separately using paired, two-tailed t-tests. For the pre-drug CPT, perceived pain (p = 0.4378), MSNA burst frequency responses (p = 0.7375), and mean BP responses (p = 0.6457) were not different between trials. For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662). Finally, during the post-drug CPT, there was a moderate relation between cardiac output and BP responses after placebo administration (r = 0.53, p = 0.0121), but this relation was effectively absent after ketamine administration (r = -0.12, p = 0.5885). These data suggest that low dose ketamine administration attenuates perceived pain and pressor, but not MSNA burst frequency, responses during a CPT. This article is protected by copyright. All rights reserved.",2020,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","['healthy humans', 'Twenty-two adults (10F/12M', '27±6', 'painful stimuli in humans']","['cold pressor tests (CPT; hand in ∼0.4°C ice bath for two minutes) pre- and five minutes post-drug administration (20 mg ketamine or saline', 'placebo', 'ketamine']","['mean BP responses', 'pain and pressor', 'autonomic cardiovascular regulation', 'pain perception and blood pressure', 'blood pressure', 'pain', 'pain perception (100 mm visual analog scale), muscle sympathetic nerve activity (MSNA; microneurography, 12 paired recordings) and beat-to-beat blood pressure (BP; photoplethysmography', 'cardiac output and BP responses', 'autonomic cardiovascular responses', 'pain perception and reduces blood pressure', 'MSNA burst frequency responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0556914', 'cui_str': 'Ice bath treatment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",22.0,0.134162,"For the post-drug CPT, ketamine compared to placebo administration attenuated perceived pain (p<0.0001) and mean BP responses (p = 0.0047), but did not attenuate MSNA burst frequency responses (p = 0.3662).","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hendrix', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Cimino', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Luke N', 'Initials': 'LN', 'LastName': 'Belval', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hinojosa-Laborde', 'Affiliation': 'US Army Institute of Surgical Research, JBSA Fort Sam Houston, TX, USA.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",The Journal of physiology,['10.1113/JP280706']
2332,33017060,Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti-meshes and collagen membranes. 1-year results of a randomized clinical trial.,"OBJECTIVES


The aim of this study was to evaluate hard and soft tissues around implants placed in posterior mandible 1 year after vertical ridge augmentation (VRA).
MATERIALS AND METHODS


40 patients with vertical defects were enrolled and treated according to the study protocol. Patients were randomly divided into two study groups: reinforced-PTFE membranes (group-A) and titanium-meshes plus collagen membranes (group-B). All patients received simultaneously implants which were evaluated after prosthetic restoration at baseline and after 1 year, using the following parameters: peri-implant-bone-levels (PBL), interproximal-bone-peaks (IBP), pocket-probing-depth (PPD), bleeding-on-probing (BoP), plaque-index(mPI), gingival-index(mGI), keratinized-tissue-thickness/width (tKT and wKT), and fornix-depth (FD). Statistical analysis was performed to investigate any statistically significant differences and/or correlations (P=0.05).
RESULTS


30 patients were completely followed-up according to the study protocol. After 1 year, implants showed a change of PBL from 0.12 to 0.76 mm, with marginal bone loss of 0.67 and 0.61 mm for group A and B, respectively, without significant differences (P>0.9337). The estimated difference between treatments for the change from baseline in PBL was -0.05 (95% CI -0.27 to 0.16). Statistical analysis revealed strong correlations between PBL and IBP (P<0.0001). However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (P>0.05).
CONCLUSION


The results indicate that GBR treatment with titanium-meshes plus collagen membranes (Group B) compared to reinforced-PTFE membranes does not appear to be inferior or superior in terms of PBL change. In both groups, hard and soft tissue were stable after 1 year of follow-up, with a peri-implant bone loss less than 1.0 mm in the first year.",2020,"However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (P>0.05).
","['40 patients with vertical defects were enrolled and treated according to the study protocol', '30 patients were completely followed-up according to the study protocol']","['Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti-meshes and collagen membranes', 'vertical ridge augmentation (VRA', 'reinforced-PTFE membranes (group-A) and titanium-meshes plus collagen membranes']","['PBL', 'PPD, mPI, mGI, tKT, wKT, and FD (P>0.05', 'peri-implant-bone-levels (PBL), interproximal-bone-peaks (IBP), pocket-probing-depth (PPD), bleeding-on-probing (BoP), plaque-index(mPI), gingival-index(mGI), keratinized-tissue-thickness/width (tKT and wKT), and fornix-depth (FD', 'change of PBL', 'marginal bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0929313,"However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (P>0.05).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cucchi', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum - University of Bologna, Bologna, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Vignudelli', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum - University of Bologna, Bologna, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Fiorino', 'Affiliation': 'Catholic University of Sacred Heart, University Polyclinic Foundation A. Gemelli (IRCCS). Unit of Dentistry and Maxillofacial Surgery, Rome, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Pellegrino', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum - University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Corinaldesi', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum - University of Bologna, Bologna, Italy.'}]",Clinical oral implants research,['10.1111/clr.13673']
2333,33017065,Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures.,"OBJECTIVES/HYPOTHESIS


While virtual reality (VR) has been used as analgesia and anxiolysis for invasive procedures, no literature exists on the use of VR in the pediatric otolaryngology setting. The purpose of this study was to determine the efficacy of VR in reducing pain and anxiety for pediatric otolaryngology patients.
METHODS


A total of 53 patients aged 7-17 undergoing in-office nasal endoscopies were included. Patients were randomized to receive VR or standard of care. Procedural pain, anxiety, and satisfaction scores were recorded from patients and caregivers. The physician filled out a childhood emotional manifestation scale (CEMS).
STUDY DESIGN


Randomized controlled trial.
RESULTS


Patients in VR group reported a significant decrease in pain (0.80 ± 1.06 vs. 2.26 ± 2.38, P = .018) and anxiety (9.50 ± 12.48 vs. 38.48 ± 29.83, P = .0002) and increase in procedural satisfaction (6.40 ± 0.77 vs. 4.74 ± 1.74, P = .0002) compared to patients in control group. CEMS scores were significantly reduced in VR group (5.15 ± 0.46 vs. 9.64 ± 5.66, P = .0001) and caregiver anxiety levels were significantly reduced in VR group (11.50 ± 17.67 vs. 27.39 ± 30.48, P = .041) compared to control group. There were no reported side effects. Procedural time did not significantly differ between groups.
CONCLUSIONS


For pediatric otolaryngology patients undergoing in-office nasal endoscopies, VR is a safe and effective form of distraction analgesia and anxiolysis, significantly reducing pain and increasing procedural satisfaction for patients. In addition, VR significantly reduces anxiety for both patients and caregivers without disrupting procedural efficiency and workflow.
LEVEL OF EVIDENCE


2. Laryngoscope, 2020.",2020,"Procedural time did not significantly differ between groups.
","['pediatric otolaryngology patients', '53 patients aged 7-17 undergoing in-office nasal endoscopies were included']","['VR or standard of care', 'VR']","['pain and anxiety', 'procedural satisfaction', 'CEMS scores', 'side effects', 'Procedural time', 'childhood emotional manifestation scale (CEMS', 'Procedural pain, anxiety, and satisfaction scores', 'anxiety', 'caregiver anxiety levels', 'pain']","[{'cui': 'C1641593', 'cui_str': 'Pediatric otolaryngology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",53.0,0.0523178,"Procedural time did not significantly differ between groups.
","[{'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Sen J', 'Initials': 'SJ', 'LastName': 'Ninan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Laitman', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Goldrich', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Alfred M', 'Initials': 'AM', 'LastName': 'Iloreta', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}, {'ForeName': 'Aldo V', 'Initials': 'AV', 'LastName': 'Londino', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29148']
2334,33002071,J-shaped relationship between cardiovascular risk and efficacy of intensive blood pressure reduction: A post-hoc analysis of the SPRINT trial.,"BACKGROUND


In the 2017 ACC/AHA hypertension guidelines, a 10-year risk of more than 10% is considered for initiation of intensive blood pressure reduction. The current study aimed to determine which cut off limit of cardiovascular risk for starting intensive blood pressure reduction is beneficial.
DESIGN


A Secondary Analysis of Systolic Blood Pressure Intervention Trial (SPRINT).
METHODS


Data from the SPRINT Trial was obtained from the NHLBI Data Repository Center. In the SPRINT, non-diabetic participants with SBP of ≥ 130 mmHg were randomly assigned to intensive and standard treatment arms with SBP targets of < 120 and < 140 mmHg, respectively. This study analyzed data from non-diabetic participants less than 75 years of age without cardiovascular or chronic kidney disease. The primary composite outcome was myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. Cox regression models were used to examine the risk of the occurrence of the SPRINT primary composite outcome. To identify the relationship between BP values and the log hazards, natural cubic spline functions were performed.
RESULTS


In the analysis, 4292 patients were enrolled. The results demonstrated a clear J-shaped relationship between the effect of intensive blood pressure control and the risk of CVD events and 10-year Framingham cardiovascular risk levels at a cut-off limit of approximately <7%.
CONCLUSIONS


This post-hoc secondary analyses of the SPRINT trial showed that a cut off value of more than 7% may be useful in selecting patients suitable for initiation of blood pressure reduction.",2020,"The primary composite outcome was myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.","['4292 patients were enrolled', 'non-diabetic participants less than 75 years of age without cardiovascular or chronic kidney disease', 'diabetic participants with SBP of ≥ 130 mmHg']",['intensive blood pressure reduction'],"['intensive blood pressure control and the risk of CVD events and 10-year Framingham cardiovascular risk levels', 'myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",4292.0,0.235369,"The primary composite outcome was myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Attar', 'Affiliation': 'Cardiovascular Research Center, TAHA Clinical Trial Group, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nouri', 'Affiliation': ""Students' Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.""}, {'ForeName': 'Roham', 'Initials': 'R', 'LastName': 'Borazjani', 'Affiliation': ""Students' Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.""}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Cardiovascular Research Center, TAHA Clinical Trial Group, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",PloS one,['10.1371/journal.pone.0240102']
2335,33002731,Gamma-transcranial alternating current stimulation and theta-burst stimulation: inter-subject variability and the role of BDNF.,"OBJECTIVE


The main limitation of neuromodulation techniques is inter-subject variability. Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS) allows to shape cortical plasticity. However, it is unknown whether γ-tACS modifies TBS-induced response variability. In this study, we measured the inter-subject variability of TBS-γ tACS and controlled the effect of the Brain-Derived Neurotrophic Factor (BDNF) Val66Met polymorphism.
METHODS


Intermittent TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS were applied in randomised sessions. Inter-subject variability was measured using grand average and clustering methods. TBS-γ tACS effects on motor evoked potentials (MEP) were compared between Val/Val and Met carriers.
RESULTS


We found that γ-tACS boosted iTBS-induced MEP facilitation and cancelled cTBS-induced MEP depression. Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders. The clustering method demonstrated that TBS-γ tACS response varied between subjects, a phenomenon unrelated to the BDNF genotype.
CONCLUSIONS


Enhancing γ oscillations through tACS boosts iTBS-induced LTP-like plasticity and suppresses cTBS-induced LTD-like plasticity of the primary motor cortex in a reliable manner. The BDNF Val66Met polymorphism does not influence these effects.
SIGNIFICANCE


Since γ-tACS significantly increases the number of iTBS responders, it may be used in clinical settings.",2020,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,[],"['Gamma-transcranial alternating current stimulation and theta-burst stimulation', 'γ-tACS', 'TBS-γ tACS', 'Combining theta-burst stimulation (TBS) with gamma-transcranial alternating current stimulation (γ-tACS', 'TBS (iTBS)-sham tACS, iTBS-γ tACS, continuous TBS (cTBS)-sham tACS, and cTBS-γ tACS']","['motor evoked potentials (MEP', 'TBS-γ tACS response', 'percentage of iTBS responders']",[],"[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]",,0.0513527,Grand average analysis showed that γ-tACS prominently increased the percentage of iTBS responders and cTBS non-responders.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guerra', 'Affiliation': 'IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asci', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Zampogna', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': ""D'Onofrio"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Petrucci', 'Affiliation': ""Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; Sant'Andrea University Hospital, Rome, Italy.""}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Ginevrino', 'Affiliation': 'Istituto di Medicina Genomica, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy; Laboratory of Medical Genetics, Bambino Gesù Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berardelli', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy. Electronic address: alfredo.berardelli@uniroma1.it.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Suppa', 'Affiliation': ""IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, IS, Italy; Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, 00185 Rome, Italy.""}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.08.017']
2336,33002745,Comparison of the effectiveness of the virtual simulator and video-assisted teaching on intravenous catheter insertion skills and self-confidence: A quasi-experimental study.,"BACKGROUND


With the advancement of technology, methods such as clinical scenarios, role playing, video demonstration and simulation are now used to develop psychomotor skills in nursing education. Virtual reality and video-assisted teaching are useful technologies for the development of skills and self-confidence. In the literature, there is a lack of studies comparing the effects of the two methods.
OBJECTIVES


The aim of study is to compare the effect of the virtual simulator and video assisted teaching on the level of intravenous catheterization skills and self-confidence of nursing students. Thus, students are enabled to develop skills and work efficiently without the need for an instructor.
METHODS


This study was a randomized controlled quasi-experimental study. A total of 60 students was included in the study (30 in the virtual simulator group and 30 in the video group). In the virtual simulator group, each student performed an intravenous catheter insertion in the virtual intravenous simulator. In the video group, each student watched a training video on the peripheral intravenous catheterization skill in a classroom setting. Each of the students' level of intravenous catheterization knowledge, psychomotor skill and self-confidence score was evaluated.
RESULTS


Post-test knowledge scores was higher than pretest knowledge scores for both groups. There were no significant difference between the groups in terms of post-test scores. Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
CONCLUSION


Teaching with the virtual simulator contributed to the students' skills more than the method used in the video training. Both methods are effective in the development of knowledge and self-confidence related to intravenous catheterization.",2020,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","['60 students was included in the study (30 in the virtual simulator group and 30 in the video group', 'nursing students']","['Virtual reality and video-assisted teaching', 'virtual simulator and video assisted teaching', 'virtual simulator and video-assisted teaching']","[""Students' scores of psychomotor skills"", 'self-confidence scores', 'intravenous catheterization knowledge, psychomotor skill and self-confidence score']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",60.0,0.0559607,"Students' scores of psychomotor skills were found to be higher in the virtual simulator group and self-confidence scores were similar in both groups.
","[{'ForeName': 'Elif Günay', 'Initials': 'EG', 'LastName': 'İsmailoğlu', 'Affiliation': 'Izmir Bakircay University, İzmir, Turkey. Electronic address: elif.ismailoglu@bakircay.edu.tr.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Orkun', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'İsmet', 'Initials': 'İ', 'LastName': 'Eşer', 'Affiliation': 'Ege University, İzmir, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Zaybak', 'Affiliation': 'Ege University, İzmir, Turkey.'}]",Nurse education today,['10.1016/j.nedt.2020.104596']
2337,33002752,A comparison of ultrasound-guided rotator interval and posterior glenohumeral injection techniques for MR shoulder arthrography.,"PURPOSE


The aim of this prospective, randomized study was to compare the performance of a rotator interval approach with the posterior glenohumeral approach for ultrasound-guided contrast injection prior to MR shoulder arthrography.
METHOD


This study was approved by the institutional review board. One hundred and twenty consecutive patients referred for MR shoulder arthrography were randomized into four groups: rotator interval approach in-plane (n = 30); rotator interval approach out-of-plane (n = 30); posterior approach in-plane (n = 30); and posterior approach out-of plane (n = 30). Outcome measures included procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10). MR arthrograms were assessed for adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage.
RESULTS


All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography. In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance. The posterior glenohumeral approach was less technically demanding though had a higher frequency of contrast leakage and caused more patient discomfort than the rotator interval approach.
CONCLUSION


For ultrasound-guided shoulder joint injection, an in-plane approach is preferable. The posterior glenohumeral approach is less technically demanding though causes more patients discomfort than the rotator interval approach possibly due to the longer needle path.",2020,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","['One hundred and twenty consecutive patients referred for MR shoulder arthrography', 'MR shoulder arthrography', 'All 120 patients had a successful ultrasound-guided injection with adequate joint distension and diagnostic utility for MR arthrography']","['posterior glenohumeral approach for ultrasound-guided contrast injection', 'ultrasound-guided rotator interval and posterior glenohumeral injection techniques', 'rotator interval approach in-plane (n\xa0=\xa030); rotator interval approach out-of-plane (n\xa0=\xa030); posterior approach in-plane (n\xa0=\xa030); and posterior approach out-of plane']","['procedure time, number of injection attempts, patient-reported pain score (0-10), and radiologist-reported technical difficulty (0-10', 'patient discomfort', 'adequacy of joint distension, diagnostic utility, and extra-capsular contrast leakage']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0203224', 'cui_str': 'Arthrography of shoulder'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282419', 'cui_str': 'Technical Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",120.0,0.0381212,"In-plane needle guidance was less technically demanding, quicker, required fewer injection attempts, and had a lower frequency of contrast leakage than out-of-plane needle guidance.","[{'ForeName': 'Carita', 'Initials': 'C', 'LastName': 'Tsoi', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chris S C', 'Initials': 'CSC', 'LastName': 'Tsai', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Eric K C', 'Initials': 'EKC', 'LastName': 'Law', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ryan K L', 'Initials': 'RKL', 'LastName': 'Lee', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Alex W H', 'Initials': 'AWH', 'LastName': 'Ng', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Griffith', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. Electronic address: griffith@cuhk.edu.hk.'}]",Clinical imaging,['10.1016/j.clinimag.2020.08.031']
2338,33002791,Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.,"OBJECTIVES


Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population.
MATERIALS AND METHODS


One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence.
RESULTS


There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants.
CONCLUSIONS


The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted.
TRIAL REGISTRATION


NCT01550822.",2020,There were no significant changes in primary or secondary outcomes at 6 months.,"['One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack', 'Stroke Survivors', 'Healthy Eating and Lifestyle after Stroke']","['HEALS intervention', 'occupational therapist-led group lifestyle intervention vs. usual care', 'intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives', 'didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity', 'occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS', 'Lifestyle Intervention']","['change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care', 'change in body mass index, fruit/vegetable intake, and physical activity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.121269,There were no significant changes in primary or secondary outcomes at 6 months.,"[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States; Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; Los Angeles County Department of Health Services, Los Angeles, CA, United States. Electronic address: towfighi@usc.edu.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States; University of Cincinnati, Cincinnati, OH, United States.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, CA, United States. Electronic address: Natalie.valle@stjoe.org.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente, Los Angeles, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Annaliese', 'Initials': 'A', 'LastName': 'Espinosa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Dombish', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, 1100 N State St, A4E, Los Angeles, CA 90033, United States. Electronic address: chu381@usc.edu.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Atkins', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105323']
2339,33004724,Effectiveness of different behavior guidance techniques in managing children with negative behavior in a dental setting: A randomized control study.,"Background


Dental fear is a common cause of uncooperative behavior among young children, which poses a challenge in providing effective dental treatment. With the advancements in technology, several behavior guidance techniques in the form of distraction have emerged over time for managing uncooperative pediatric dental patients.
Aim


The aim of this study is to compare and evaluate the effectiveness of four different behavior guidance techniques in managing uncooperative pediatric patients by measuring pre- and post-operative dental fear/anxiety levels using physiological and nonphysiological parameters.
Methodology


Sixty systemically healthy children aged 5-8 years with negative behavior as per Frankl's Rating Scale, requiring restoration were included in the study and randomly divided into four equal groups (n = 15), based on the guidance techniques used: Tell-Show-Do (TSD) as a control group and audio distraction, audiovisual distraction (AVD) (virtual reality [VR]) and Mobile Phone Game Distraction as test groups. Pre- and post-intervention levels of the child's fear/anxiety were assessed using both physiological (blood pressure and pulse rate) and nonphysiological (facial image scale) parameters. The data were evaluated using t-test and one-way ANOVA test.
Results


A statistically significant difference was observed in both physiological and non-physiological parameters post-intervention in the groups with a maximum decrease in the AVD (VR) group.
Conclusions


AVD (VR) was found to be the most effective while TSD alone as the least effective behavior guidance technique in reducing dental fear/anxiety in uncooperative pediatric dental patients.",2020,"A statistically significant difference was observed in both physiological and non-physiological parameters post-intervention in the groups with a maximum decrease in the AVD (VR) group.
","['managing uncooperative pediatric patients', 'young children', 'managing children with negative behavior in a dental setting', 'uncooperative pediatric dental patients', ""Methodology\n\n\nSixty systemically healthy children aged 5-8 years with negative behavior as per Frankl's Rating Scale, requiring restoration""]","['behavior guidance techniques', 'guidance techniques used: Tell-Show-Do (TSD) as a control group and audio distraction, audiovisual distraction (AVD) (virtual reality [VR]) and Mobile Phone Game Distraction']","['physiological (blood pressure and pulse rate) and nonphysiological (facial image scale) parameters', 'dental fear/anxiety']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0161071,"A statistically significant difference was observed in both physiological and non-physiological parameters post-intervention in the groups with a maximum decrease in the AVD (VR) group.
","[{'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Pande', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rana', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Srivastava', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India.'}, {'ForeName': 'Noopur', 'Initials': 'N', 'LastName': 'Kaushik', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India.'}]",Journal of the Indian Society of Pedodontics and Preventive Dentistry,['10.4103/JISPPD.JISPPD_342_20']
2340,33007442,Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.,"INTRODUCTION


The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.
OBJECTIVE


To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.
METHODS AND ANALYSIS


The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.",2020,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.",['older adults in intensive care units'],"['PCplanner intervention', 'PCplanner vs. usual care']","['goal concordance of care, patient-centeredness of care, and quality of communication at 1\u202fweek post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder', 'change in unmet palliative care needs measured by the NEST instrument']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.166302,"Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Casarett', 'Affiliation': 'Department of Medicine, Section of Palliative Care and Hospice Medicine, Duke University, Durham, NC, United States of America. Electronic address: David.casarett@duke.edu.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Haines', 'Affiliation': 'Department of Surgery, Division of Trauma and Critical Care and Acute Care Surgery, Duke University, Durham, North, Carolina;, United States of America. Electronic address: krista.haines@duke.edu.'}, {'ForeName': 'Mashael', 'Initials': 'M', 'LastName': 'Al-Hegelan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: mashael.alhegelan@duke.edu.'}, {'ForeName': 'Raquel R', 'Initials': 'RR', 'LastName': 'Bartz', 'Affiliation': 'Department of Anesthesia, Division of Critical Care Medicine, Duke University, Durham, NC, United States of America. Electronic address: raquel.bartz@duke.edu.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC, United States of America. Electronic address: jason.katz@duke.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Naglee', 'Affiliation': 'Department of Anesthesia, Division of Neurology, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Deepshikha', 'Initials': 'D', 'LastName': 'Ashana', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: deepshikha.ashana@duke.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gilstrap', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: daniel.gilstrap@duke.edu.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: jessie.gu@duke.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parish', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States of America. Electronic address: alice.parish@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Krishnamaneni', 'Affiliation': 'Duke Health Technology Solutions, Duke University, Durham, NC, United States of America. Electronic address: deepthi.krishnamaneni@duke.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Corcoran', 'Affiliation': 'Office of Academic Solutions and Information Systems, Duke University, Durham, NC, United States of America. Electronic address: andrew.corcoran@duke.edu.'}, {'ForeName': 'Sharron L', 'Initials': 'SL', 'LastName': 'Docherty', 'Affiliation': 'School of Nursing, Duke University, Durham, NC, United States of America. Electronic address: sharron.docherty@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106163']
2341,33007492,Sinus augmentation - autograft vs. fresh frozen allograft: Bone density dynamics and implant stability.,"OBJECTIVES


Compare bone density changes and initial implant stability following sinus augmentation with autogenous bone (AB) vs. fresh frozen bone (FFB).
MATERIALS AND METHODS


Randomized, prospective, split mouth study. Sinus augmentation executed using either AB or FFB. Dental implants were inserted after 6 months of healing. Implant dimensions and insertion torques were recorded. Prostheses were delivered 6 months thereafter. All patients had computerized tomography (CT) scans 1 week (T1) and 6 months (T2) after initial bone grafting. Third CT (T3) was taken 12 months after prosthesis delivery. Data from CT scans was used to analyze bone density at each period.
RESULTS


A total of 15 patients (8 males, 7 females) following bilateral sinus augmentation procedures, were included. Mean age was 54 ± 5 years (range 48-60 years). All patients had 3 CT examinations. The initial augmented AB density was higher than the initial FFB density. Nevertheless, density differences between the two groups were not statistically significant at any time frame. At T2 density of both grafts showed a statistically significant increase. A significant increase from T2 to T3 was noted only for the FFB group. Implant insertion torque was significantly higher in the FFB group. Insertion torque ≥32 N/cm was achieved in significantly more patients in the FFB group.
CONCLUSION


The use of FFB for sinus augmentation is a reliable option of graft material. The newly formed bone quality performance, evaluated by CBCT density, is as good as AB, allowing predictable initial implant stability and osseointegration. Unnecessary morbidity associated with AB harvesting is thus avoided.",2020,Implant insertion torque was significantly higher in the FFB group.,"['Mean age was 54\u2009±\u20095 years (range 48-60 years', 'All patients had 3 CT examinations', '15 patients (8 males, 7 females) following bilateral sinus augmentation procedures, were included']","['Sinus augmentation - autograft vs. fresh frozen allograft', 'sinus augmentation with autogenous bone (AB) vs. fresh frozen bone (FFB', 'FFB', 'AB or FFB']","['AB density', 'Implant insertion torque', 'Implant dimensions and insertion torques']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",15.0,0.0277306,Implant insertion torque was significantly higher in the FFB group.,"[{'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Chaushu', 'Affiliation': 'Attending, Department of Periodontology and Implant Dentistry, School of Dentistry, Tel Aviv University, Israel. Electronic address: liat.natanel@gmail.com.'}, {'ForeName': 'Erick Ricardo', 'Initials': 'ER', 'LastName': 'Silva', 'Affiliation': 'Attending, Department of Oral and Maxillofacial Surgery and Periodontology School of Dentistry of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: erickricardo.rp@gmail.com.'}, {'ForeName': 'Vitor Ferreira', 'Initials': 'VF', 'LastName': 'Balan', 'Affiliation': 'MSc Student in Oral and Maxillofacial Surgery - Dental School of University of Sao Paulo - Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: vitor.balan@usp.br.'}, {'ForeName': 'Gavriel', 'Initials': 'G', 'LastName': 'Chaushu', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, School of Dental Medicine, Tel Aviv University, Tel-Aviv, Department of Oral & Maxillofacial Surgery, Rabin Medical Center, Campus Beilinson, Petah Tiqwa, Israel. Electronic address: gabi.chaushu@gmail.com.'}, {'ForeName': 'Samuel Porfirio', 'Initials': 'SP', 'LastName': 'Xavier', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology. School of Dentistry of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: samuelpxavier@yahoo.com.br.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.08.012']
2342,33007709,Non-invasive ventilation improves exercise tolerance and peripheral vascular function after high-intensity exercise in COPD-HF patients.,"AIM


Evaluate the acute effects of non-invasive positive pressure ventilation (NiPPV) during high-intensity exercise on endothelial function in patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF).
METHODS


This is a randomized, double blinded, sham-controlled study involving 14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography. On two different days, patients performed incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV (bilevel mode - Astral 150) in a random order until the limit of tolerance (Tlim). Endothelial function was evaluated by flow mediated vasodilation (FMD) at three time points: 1) Baseline; 2) immediately post-exercise with NiPPV; and 3) immediately post-exercise with Sham.
RESULTS


Our patients had a mean age of 70 ± 7 years, FEV 1  1.9 ± 0.7 L and LVEF 41 ± 9%. NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s p = 0.015) and SpO 2  (NiPPV: 94.7 ± 3.5% vs Sham: 92.7 ± 5.2% p = 0.03). Also, NiPPV was able to produce a significant increase in FMD (%) (NiPPV: 9.2 ± 3.1 vs Sham: 3.6 ± 0.7, p < 0.05), FMD (mm) (NiPPV: 0.41 ± 0.18 vs Sham: 0.20 ± 0.11, p < 0.05), Blood flow velocity (NiPPV: 33 ± 18 vs Baseline: 20 ± 14, p < 0.05) and Shear Stress (SS) (NiPPV: 72 ± 38 vs Baseline: 43 ± 25, p < 0.05). We found correlation between Tlim vs. ΔSS (p = 0.03; r = 0.57). Univariate-regression analysis revealed that increased SS influenced 32% of Tlim during exercise with NiPPV.
CONCLUSION


NiPPV applied during high-intensity exercise can acutely modulate endothelial function and improve exercise tolerance in COPD-HF patients. In addition, the increase of SS positively influences exercise tolerance.",2020,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"['patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF', 'Our patients had a mean age of 70\xa0±\xa07 years, FEV 1', '14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography', 'COPD-HF patients']","['non-invasive positive pressure ventilation (NiPPV', 'NIPPV', 'high-intensity exercise', 'incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV', 'NiPPV']","['Shear Stress (SS) ', 'SS positively influences exercise tolerance', 'Blood flow velocity', 'FMD', 'Endothelial function', 'exercise tolerance and peripheral vascular function', 'exercise tolerance', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",14.0,0.444389,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"[{'ForeName': 'Cássia', 'Initials': 'C', 'LastName': 'da Luz Goulart', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: Luz.cassia@hotmail.com.'}, {'ForeName': 'Flávia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: fla.rossi@hotmail.com.'}, {'ForeName': 'Adriana S', 'Initials': 'AS', 'LastName': 'Garcia de Araújo', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: garciadrica@hotmail.com.'}, {'ForeName': 'Guilherme Peixoto', 'Initials': 'GP', 'LastName': 'Tinoco Arêas', 'Affiliation': 'Human Physiology Laboratory, Physiology Department, Federal University of Amazonas, UFAM, Manaus, AM, Brazil. Electronic address: Guilhermepta@hotmail.com.'}, {'ForeName': 'Sílvia Cristina', 'Initials': 'SC', 'LastName': 'Garcia de Moura', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: silvinhacgmoura@gmail.com.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: amcatai50@gmail.com.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: mendesrg@hotmail.com.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: shanep@uic.edu.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: rarena70@gmail.com.'}, {'ForeName': 'Andréa Lúcia', 'Initials': 'AL', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Department of Physical Education and Health, University of Santa Cruz do Sul, Rio Grande do Sul, Brazil. Electronic address: andreag@unisc.br.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106173']
2343,33007966,Acute and Chronic Catabolic Responses to  CrossFit ®  and Resistance Training in Young Males .,"Given the wide variety of conditioning program trainings employed, the present study compared the catabolic effects induced by CrossFit ®  and resistance training in moderately trained subjects. Twenty males joined either the CrossFit ®  group (n = 10; 30 min/day of ""workout of the day"") or the resistance training (RT) group (n = 10; 30 min/day of resistance exercises) thrice a week, for 8 weeks. Salivary levels of cortisol, interleukin 1-beta (IL-1β), and uric acid were assessed via enzyme-linked immunosorbent assays before (PRE) and 30-min after (POST) SESSION 1 and SESSION 24. Variables' percentual changes were computed as (POST-PRE)/PRE*100 in each session (Δ%). CrossFit ®  acutely increased cortisol levels in both sessions, with a significant decrease in Δ%cortisol from SESSION 1 to 24. In the RT group, cortisol values decreased in both sessions, only acutely. A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups. While uric acid levels increased in both groups acutely, a chronic downregulation of Δ%uric acid, from SESSION 1 to 24, was appreciated for the RT group only. Overall, CrossFit ®  appeared to induce more intense effects than the RT program as to the investigated catabolic responses.",2020,"A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups.","['moderately trained subjects', 'Twenty males joined either the', 'Young Males ']","['CrossFit ®  and resistance training', 'resistance training (RT', 'CrossFit ®  and Resistance Training', 'CrossFit ®']","['IL-1β levels', 'uric acid levels', 'Salivary levels of cortisol, interleukin 1-beta (IL-1β), and uric acid were assessed via enzyme-linked immunosorbent assays before (PRE', 'cortisol levels', 'cortisol values']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0227177,"A significant decrease in IL-1β levels was registered acutely in both groups, in both sessions, whereas Δ%IL-1β was not different between the two groups.","[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Faelli', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Bisio', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Codella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università Degli Studi di Milano, 20133 Milano, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Ferrando', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Perasso', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Panascì', 'Affiliation': 'Centro Polifunzionale di Scienze Motorie, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Saverino', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Ruggeri', 'Affiliation': 'Department of Experimental Medicine, Università degli Studi di Genova, 16132 Genoa, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17197172']
2344,33007981,"Effects of Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation on Inflammatory Adipokine, Cytokine Concentrations, and Body Composition in Obese Adolescent Boys.","We examined the effects of six weeks of dark chocolate supplementation combined with interval jump rope exercise (JRE) on inflammatory cytokines, adipokines, and body composition in obese adolescent boys. Forty-eight obese adolescent boys (age  = 15.4  ±  1.1 years and body mass index  =  32.2  ±  2.4 kg/m 2 ) were randomly assigned into one of four groups: JRE + white chocolate (JW;  n  = 13), JRE + dark chocolate supplementation (JD;  n  = 13), dark chocolate supplementation (DS;  n  = 12), or control (C;  n  = 12). Participants in JW and JD groups performed JRE for three times per week for six weeks. Participants in the DS and JD groups consumed 30 g of dark chocolate containing 83% of cocoa. Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin)) were evaluated prior to and after the intervention trials. All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations. The improvements in these parameters were greater in the JD group, and additionally, chemerin concentrations decreased only in the JD group. JD enhanced adiponectin concentrations and decreased IL-6 concentrations compared to C. Moreover, JD significantly reduced chemerin concentrations, an effect not observed in any of the other interventions. We demonstrated that dark chocolate supplementation potentiated JRE-induced decreases in body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations in obese adolescent boys. Therefore, JRE combined with dark chocolate supplementation could be a beneficial in reducing obesity-induced inflammation in adolescent boys.",2020,"All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","['obese adolescent boys', 'Forty-eight obese adolescent boys (age\u2009 = 15.4\u2009 ± \u20091.1\u2009years and body mass index\u2009 = \u200932.2\u2009 ± \u20092.4\u2009kg/m 2 ', 'adolescent boys', 'Obese Adolescent Boys']","['dark chocolate containing 83% of cocoa', 'JRE', 'dark chocolate supplementation combined with interval jump rope exercise (JRE', 'JRE combined with dark chocolate supplementation', 'Interval Jump Rope Exercise Combined with Dark Chocolate Supplementation', 'JRE + white chocolate (JW;  n  = 13), JRE + dark chocolate supplementation (JD;  n  = 13), dark chocolate supplementation']","['Inflammatory Adipokine, Cytokine Concentrations, and Body Composition', 'body mass, WHR, FM, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, chemerin as well as increases irisin and adiponectin concentrations', 'inflammatory cytokines, adipokines, and body composition', 'Body composition, pro-inflammatory cytokines ((hs-CRP, TNF-α, IL-6), adipokines (leptin, resistin, RBP-4, chemerin, MCP-1), and anti-inflammatory adipokines (irisin, adiponectin', 'adiponectin concentrations and decreased IL-6 concentrations', 'obesity-induced inflammation', 'chemerin concentrations', 'body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C3853217', 'cui_str': 'Dark chocolate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0453439', 'cui_str': 'White chocolate'}]","[{'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0035342', 'cui_str': 'Retinol binding protein'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",,0.0356434,"All three intervention trials significantly ( p  < 0.05) decreased body mass, waist-hip ratio, fat mass, hs-CRP, TNF-α, IL-6, leptin, resistin, RBP-4, and MCP-1, and increased irisin and adiponectin concentrations.","[{'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand 9717434765, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand Moghadam', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran 1961733114, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan 81746-73441, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Eskandari', 'Affiliation': 'Qaen school of Nursing and Midwifery, Birjand University of Medical Sciences, Birjand 9717853577, Iran.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, University Hospital of Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, VA 22207, USA.'}]",Nutrients,['10.3390/nu12103011']
2345,33008106,Hypoxic Pilates Intervention for Obesity: A Randomized Controlled Trial.,"This study examined the effect of Pilates training under hypoxia, a novel treatment method, for obesity. Thirty-two Korean women with obesity (age: 34-60 (47.5 ± 7.5) years) were randomly assigned to control (CON; n = 10), normoxic Pilates training (NPTG; n = 10), and hypoxic Pilates training groups (HPTG; n = 12). The NPTG and HPTG performed 50 min of Pilates training using a tubing band for 12 weeks (3 days/week) in their respective environmental conditions (NPTG: normoxic condition, inspired oxygen fraction (F i O 2 ) = 20.9%; HPTG: moderate hypoxic condition, F i O 2  = 14.5%). The CON maintained their daily lifestyle without intervention. All subjects underwent body composition, blood pressure, arterial stiffness, vascular endothelial function, cardiometabolic biomarker, hemorheological function, and aerobic performance measurements before and after the intervention. The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG. However, compared with the CON and NPTG, the HPTG did not show improvement in other parameters. Hypoxic Pilates intervention is a novel and successful method for promoting endothelial and hemorheological functions in women with obesity.",2020,"The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG.","['Obesity', 'Thirty-two Korean women with obesity (age: 34-60 (47.5 ± 7.5) years', 'women with obesity']","['Hypoxic Pilates intervention', 'Pilates training under hypoxia', 'Hypoxic Pilates Intervention', 'normoxic Pilates training (NPTG; n = 10), and hypoxic Pilates training', 'CON']","['blood pressure, arterial stiffness, vascular endothelial function, cardiometabolic biomarker, hemorheological function, and aerobic performance measurements', 'diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte deformability'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",32.0,0.018354,"The HPTG showed a significant improvement in diastolic blood pressure, total cholesterol and triglyceride concentrations, flow-mediated dilation, and erythrocyte deformability and aggregation (all p < 0.05) compared with the CON and NPTG.","[{'ForeName': 'Kyounghwa', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Jisu', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kiwon', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Education, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197186']
2346,33008301,Comparison of real-time PCR and the Kato-Katz method for the diagnosis of soil-transmitted helminthiasis and assessment of cure in a randomized controlled trial.,"BACKGROUND


Diagnosis of soil-transmitted helminths (STHs) in developing countries is commonly based on microscopic detection of eggs in stool samples, using the Kato-Katz (KK) method, which has a poor sensitivity for detecting light intensity infections. We compared the performance of the KK method and real-time PCR in the framework of a randomized trial, which evaluated four novel treatments against Trichuris trichiura and concomitant STH infections.
RESULTS


Two stool samples obtained from 320 participants were examined at baseline and follow-up with quadruplicate KK and PCR analyses of one of the two samples using ""bead-beating"" for DNA extraction. At follow-up, 80 samples were negative according to both PCR and KK and 173 were positive with both methods for any of the STHs. Relative to PCR, the calculated sensitivity of KK at follow-up was 83.6%, 43.0% and 53.8% for T. trichiura, for hookworm and for Ascaris lumbricoides, respectively. The sensitivity of PCR compared with KK at this time point was 89.1% for T. trichiura, 72.7% for hookworm and 87.5% for A. lumbricoides. Cure rates (CRs) for T. trichiura and A. lumbricoides were slightly lower with the PCR method. For hookworm CRs with KK were mostly significantly lower, namely 36.7%, 91.1%, 72.2% and 77.8% for moxidectin, moxidectin in combination with tribendimidine, moxidectin in combination with albendazole and albendazole in combination with oxantel pamoate, respectively, whereas with PCR the CRs were 8.3%, 82.6%, 37.1% and 57.1%, respectively.
CONCLUSIONS


In conclusion, a single real-time PCR is as sensitive as quadruplicate KK for T. trichiura and A. lumbricoides detection but more sensitive for hookworm, which has an influence on the estimated treatment efficacy. PCR method with DNA extraction using the ""bead-beating protocol"" should be further promoted in endemic areas and laboratories that can afford the needed equipment. The study is registered at ISRCTN (no. 20398469).",2020,Cure rates (CRs) for T. trichiura and A. lumbricoides were slightly lower with the PCR method.,[],"['albendazole and albendazole', 'real-time PCR and the Kato-Katz method']","['Cure rates (CRs', 'sensitivity of PCR']",[],"[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]",320.0,0.0871499,Cure rates (CRs) for T. trichiura and A. lumbricoides were slightly lower with the PCR method.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Barda', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Wampfler', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland.'}, {'ForeName': 'Shaali', 'Initials': 'S', 'LastName': 'Ame', 'Affiliation': 'Laboratory Division, Public Health Laboratory-Ivo de Carneri, Chake-Chake, Tanzania.'}, {'ForeName': 'Said M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Laboratory Division, Public Health Laboratory-Ivo de Carneri, Chake-Chake, Tanzania.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Swiss Tropical and Public Health Institute, Socinstrasse 57, 4002, Basel, Switzerland. Jennifer.keiser@swisstph.ch.'}]",BMC microbiology,['10.1186/s12866-020-01963-9']
2347,33008345,"Safety and efficacy of guanfacine extended-release in adults with attention-deficit/hyperactivity disorder: an open-label, long-term, phase 3 extension study.","BACKGROUND


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


In this open-label, long-term, phase 3 extension study in Japan, 150 patients transitioned from a double-blind trial, and 41 newly enrolled patients received once daily GXR (starting dose 2 mg/day, maintenance dose 4-6 mg/day) for 50 weeks. Primary outcome measures were the frequency and nature of treatment-emergent adverse events (TEAEs); secondary outcome measures included the change from week 0 in ADHD Rating Scale IV with Adult Prompts (ADHD-RS-IV; Japanese version) total and subscale scores, Conners' Adult ADHD Rating Scales (CAARS), Clinical Global Impression-Improvement (CGI-I) and Patient Global Impression-Improvement (PGI-I) scales, and quality of life (QoL) and executive functioning measures.
RESULTS


Of all patients, 94.2% (180/191) reported ≥1 TEAE and 19.9% (38/191) discontinued because of a TEAE. Most TEAEs were mild to moderate in severity; there were two serious TEAEs and no deaths. Commonly reported TEAEs (≥10% of patients) were somnolence, thirst, nasopharyngitis, decreased blood pressure, postural dizziness, bradycardia, malaise, constipation, and dizziness. Mean changes from week 0 in ADHD-RS-IV total and subscale scores and CAARS subscale scores were significantly improved in former placebo or GXR patients and new patients at last observation (p < .0001), and the percentage of patients with very much or much improved CGI-I and PGI-I scores increased.
CONCLUSIONS


There were no major safety concerns during long-term GXR administration in adults with ADHD. After long-term treatment, patients had significant improvements from baseline in ADHD symptoms, QoL, and executive functioning.
TRIAL REGISTRATION


Japan Primary Registries Network ( https://rctportal.niph.go.jp/en/ ): JapicCTI-163232, registered 04/21/2016.",2020,"Mean changes from week 0 in ADHD-RS-IV total and subscale scores and CAARS subscale scores were significantly improved in former placebo or GXR patients and new patients at last observation (p < .0001), and the percentage of patients with very much or much improved CGI-","['adults with attention-deficit/hyperactivity disorder (ADHD', 'adults with attention-deficit/hyperactivity disorder', 'adults with ADHD', '150 patients transitioned from a double-blind trial, and 41 newly enrolled patients received']","['placebo', 'once daily GXR', 'guanfacine', 'guanfacine extended-release (GXR']","['Safety and efficacy', 'CGI', 'safety and efficacy', 'ADHD-RS-IV total and subscale scores and CAARS subscale scores', 'somnolence, thirst, nasopharyngitis, decreased blood pressure, postural dizziness, bradycardia, malaise, constipation, and dizziness', ""frequency and nature of treatment-emergent adverse events (TEAEs); secondary outcome measures included the change from week 0 in ADHD Rating Scale IV with Adult Prompts (ADHD-RS-IV; Japanese version) total and subscale scores, Conners' Adult ADHD Rating Scales (CAARS), Clinical Global Impression-Improvement (CGI-I) and Patient Global Impression-Improvement (PGI-I) scales, and quality of life (QoL) and executive functioning measures"", 'ADHD symptoms, QoL, and executive functioning']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0234987', 'cui_str': 'Postural dizziness'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",150.0,0.08863,"Mean changes from week 0 in ADHD-RS-IV total and subscale scores and CAARS subscale scores were significantly improved in former placebo or GXR patients and new patients at last observation (p < .0001), and the percentage of patients with very much or much improved CGI-","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Iwanami', 'Affiliation': 'Department of Psychiatry, Showa University School of Medicine, 6-11-11 Kita Karasuyama, Setagaya-ku, Tokyo, 157-8577, Japan. iwanami@med.showa-u.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Aiiku Counselling Office, Aiiku Research Institute, Imperial Gift Foundation Boshi-Aiiku-Kai, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Biostatistics Center, Shionogi & Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Okutsu', 'Affiliation': 'Clinical Research Department, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Japan Developmental Disorders Network, Tokyo, Japan.'}]",BMC psychiatry,['10.1186/s12888-020-02867-8']
2348,33010803,"Ultrasound-guided ilioinguinal-iliohypogastric block (ILIHB) or perifocal wound infiltration (PWI) in children: a prospective randomized comparison of analgesia quality, a pilot study.","BACKGROUND


Ilioinguinal-iliohypogastric block (ILIHB) is a well-established procedure for postoperative analgesia after open inguinal surgery in children. This procedure is effective and safe, especially when ultrasound is used. Data availability for comparing ultrasound-guided blocks versus wound infiltration is still weak. The study was designed to determine the efficacy of ultrasound-guided ILIHB (US-ILIHB) on postoperative pain control in pediatric patients following a inguinal daycase surgery, compared with perifocal wound infiltration (PWI) by the surgeon.
METHODS


This randomized, double-blinded trail was conducted in pediatric patients aged from 6 months to 4 years. The total number of children included in the study was 103. Patients were allocated at random in two groups by sealed envelopes. The ILIHB group recieved 0,2% ropivacain for US-ILIHB after anesthesia induction. The PWI group recieved 0,2% ropivacain for PWI performed by a surgeon before wound closure. Parameters recorded included the postoperative pain score, pain frequency, time to first analgesics and consumption of analgesics.
RESULTS


US-ILIHB significantly reduced the occurrence of pain within the first 24 h after surgery (7.7%, p = 0.01). Moreover, the pain-free interval until administration of the first dose of opioids was 21 min longer, on average (p = 0.003), following US-ILIHB compared to perifocal wound infiltration. 72% of children who received US-ILIHB did not require additional opioids, as compared to 56% of those who received PWI.
CONCLUSION


Thus our study demonstrates that US-ILIHB ensures better postoperative analgesia in children and should be prioritized over postoperative PWI.
TRAIL REGISTRATION


UIHBOPWIIC, DRKS00020987 . Registered 20 March 2020 - Retrospectivley registered.",2020,"RESULTS


US-ILIHB significantly reduced the occurrence of pain within the first 24 h after surgery (7.7%, p = 0.01).","['children', 'pediatric patients aged from 6\u2009months to 4\u2009years', 'Registered 20 March 2020', 'pediatric patients following a inguinal daycase surgery, compared with perifocal wound infiltration (PWI) by the surgeon']","['ultrasound-guided ILIHB (US-ILIHB', 'Ilioinguinal-iliohypogastric block (ILIHB', 'ropivacain', 'Ultrasound-guided ilioinguinal-iliohypogastric block (ILIHB) or perifocal wound infiltration (PWI']","['postoperative pain control', 'occurrence of pain', 'postoperative analgesia', 'pain-free interval until administration', 'postoperative pain score, pain frequency, time to first analgesics and consumption of analgesics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0730805,"RESULTS


US-ILIHB significantly reduced the occurrence of pain within the first 24 h after surgery (7.7%, p = 0.01).","[{'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Grosse', 'Affiliation': ""Department of Pediatric Anesthesiology, Altona Children's Hospital, Bleickenallee 38, 22763, Hamburg, Germany. Bjoern.Grosse@kinderkrankenhaus.net.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Eberbach', 'Affiliation': ""Department of Pediatric Anesthesiology, Altona Children's Hospital, Bleickenallee 38, 22763, Hamburg, Germany.""}, {'ForeName': 'Hans O', 'Initials': 'HO', 'LastName': 'Pinnschmidt', 'Affiliation': 'Center of Experimental Medicine, Institute of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Vincent', 'Affiliation': 'Department of Pediatric Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schmidt-Niemann', 'Affiliation': ""Department of Pediatric Anesthesiology, Altona Children's Hospital, Bleickenallee 38, 22763, Hamburg, Germany.""}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Reinshagen', 'Affiliation': ""Department of Pediatric Anesthesiology, Altona Children's Hospital, Bleickenallee 38, 22763, Hamburg, Germany.""}]",BMC anesthesiology,['10.1186/s12871-020-01170-z']
2349,33010810,Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study.,"BACKGROUND


In mild asthma, as-needed budesonide-formoterol reduces long-term exacerbation risk compared with as-needed short-acting β 2 -agonist (SABA), with a similar or increased reduction versus maintenance with budesonide plus as-needed SABA, despite a lower budesonide dose. In this post-hoc analysis of the SYmbicort Given as needed in Mild Asthma (SYGMA) 1 study, we investigated the short-term risk of severe exacerbations after a single day with various levels of reliever use.
METHODS


SYGMA 1 was a 52-week, double-blind, randomised, controlled, phase 3 trial, in which patients aged 12 years or older with mild asthma were randomly assigned (1:1:1) to placebo twice daily plus as-needed terbutaline 0·5 mg, placebo twice daily plus as-needed budesonide-formoterol 200-6 μg, or budesonide 200 μg twice daily plus as-needed terbutaline (ie, budesonide maintenance group). In this post-hoc analysis, we assessed the frequency of reliever use and the risk of a severe exacerbation in the 21 days after first use of more than two, four, six, or eight reliever inhalations in 24 h. SYGMA 1 is registered with ClinicalTrials.gov, NCT02149199, and is now complete.
FINDINGS


Of 5721 patients enrolled in SYGMA 1, 3849 were randomly assigned to as-needed terbutaline (n=1280), as-needed budesonide-formoterol (n=1279), or budesonide maintenance (n=1290), of whom 3836 had evaluable data (n=1277 as-needed terbutaline, n=1277 as needed budesonide-formoterol, and n=1282 budesonide maintenance). Median reliever use was 0·32 (IQR 0·08-0·91) inhalations per day for the as-needed terbutaline group, 0·29 (0·07-0·72) for the as-needed budesonide-formoterol group, and 0·16 (0·04-0·52) for the budesonide maintenance group. Compared with as-needed terbutaline, after adjustment for age, sex, randomly assigned treatment, pre-study treatment group, baseline % predicted post-bronchodilator FEV 1 , and severe exacerbation in the 12 months before enrolment in the study, the hazard ratio (HR) for severe exacerbation in the 21 days after a single day with more than two as-needed inhalations was 0·27 (95% CI 0·12-0·58; p=0·0008) with as-needed budesonide-formoterol and 0·39 (0·19-0·79; p=0·0091) with budesonide maintenance; after a single day of more than four as-needed inhalations the HR was 0·24 (0·10-0·62; p=0·0030) with as-needed budesonide-formoterol and 0·30 (0·13-0·72; p=0·0065) with budesonide maintenance; and after a single day of more than six as-needed inhalations the HR was 0·14 (0·02-1·06; p=0·057) with as-needed budesonide-formoterol and 0·43 (0·14-1·26; p=0·12) with budesonide maintenance. HRs were not calculated for more than eight as-needed inhalations due to the small number of events.
INTERPRETATION


In mild asthma, as-needed budesonide-formoterol reduces the short-term risk of severe exacerbations after a single day of higher use (more than two as-needed inhalations), even when overall use is infrequent. Use of an anti-inflammatory reliever might reduce the risk of short-term severe exacerbations by the timely provision of increased doses of as-needed inhaled corticosteroids and formoterol when symptoms occur. These findings should be further assessed in prospective randomised clinical trials.
FUNDING


AstraZeneca.",2020,Median reliever use was 0·32,"['5721 patients enrolled in SYGMA 1, 3849', 'patients aged 12 years or older with mild asthma', 'n=1290), of whom 3836 had evaluable data (n=1277 as-needed terbutaline, n=1277 as needed', 'patients with mild asthma']","['terbutaline', 'budesonide maintenance', 'placebo twice daily plus as-needed terbutaline 0·5 mg, placebo twice daily plus as-needed budesonide-formoterol 200-6 μg, or budesonide 200 μg twice daily plus as-needed terbutaline (ie, budesonide maintenance group', 'budesonide-formoterol and 0·43 (0·14-1·26', 'budesonide-formoterol and 0·30', 'budesonide-formoterol, and n=1282 budesonide maintenance', 'budesonide-formoterol', 'budesonide-formoterol (n=1279), or budesonide maintenance']","['frequency of reliever use and the risk of a severe exacerbation', 'hazard ratio (HR) for severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}]","[{'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",5721.0,0.491143,Median reliever use was 0·32,"[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': ""O'Byrne"", 'Affiliation': ""Firestone Institute for Respiratory Health, St Joseph's Healthcare and Department of Medicine, Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: obyrnep@mcmaster.ca.""}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'Centre for Lung Health, Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bateman', 'Affiliation': 'Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barnes', 'Affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Health, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Lamarca', 'Affiliation': 'AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Puu', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Keen', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Vijay K T', 'Initials': 'VKT', 'LastName': 'Alagappan', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30416-1']
2350,33010843,"Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.","BACKGROUND


Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection.
METHODS


In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.
FINDINGS


Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release).
INTERPRETATION


All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective.
FUNDING


The National Institute for Health Research Health Technology Assessment programme.",2020,All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences.,"['Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55', 'Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder', 'adults with primary frozen shoulder in secondary care (UK FROST', 'patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK']","['graduated home exercise programme supplemented by a steroid injection', 'manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy']","['shoulder pain and function (OSS', 'Oxford Shoulder Score']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0498269', 'cui_str': 'Manipulation under anesthesia'}, {'cui': 'C2936277', 'cui_str': 'Arthroscopic Capsular Release'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}]",,0.145395,All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences.,"[{'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK; The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK. Electronic address: amar.rangan@york.ac.uk.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Corbacho', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Goodchild', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals National Health Service (NHS) Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Srikesavan', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Saleema', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Charalambos P', 'Initials': 'CP', 'LastName': 'Charalambous', 'Affiliation': 'Department of Orthopaedics, Blackpool Victoria Hospital, Blackpool, UK; School of Medicine, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Hanchard', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brooksbank', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Donnelly', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sharp', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'Postgraduate Medical Institute, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Toye', 'Affiliation': 'Physiotherapy Research Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31965-6']
2351,33010927,Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial.,"BACKGROUND


Intravenous tranexamic acid (TXA) reduces bleeding deaths after injury and childbirth. It is most effective when given early. In many countries, pre-hospital care is provided by people who cannot give i.v. injections. We examined the pharmacokinetics of intramuscular TXA in bleeding trauma patients.
METHODS


We conducted an open-label pharmacokinetic study in two UK hospitals. Thirty bleeding trauma patients received a loading dose of TXA 1 g i.v., as per guidelines. The second TXA dose was given as two 5 ml (0·5 g each) i.m. injections. We collected blood at intervals and monitored injection sites. We measured TXA concentrations using liquid chromatography coupled to mass spectrometry. We assessed the concentration time course using non-linear mixed-effect models with age, sex, ethnicity, body weight, type of injury, signs of shock, and glomerular filtration rate as possible covariates.
RESULTS


Intramuscular TXA was well tolerated with only mild injection site reactions. A two-compartment open model with first-order absorption and elimination best described the data. For a 70-kg patient, aged 44 yr without signs of shock, the population estimates were 1.94 h -1  for i.m. absorption constant, 0.77 for i.m. bioavailability, 7.1 L h -1  for elimination clearance, 11.7 L h -1  for inter-compartmental clearance, 16.1 L volume of central compartment, and 9.4 L volume of the peripheral compartment. The time to reach therapeutic concentrations (5 or 10 mg L -1 ) after a single intramuscular TXA 1 g injection are 4 or 11 min, with the time above these concentrations being 10 or 5.6 h, respectively.
CONCLUSIONS


In bleeding trauma patients, intramuscular TXA is well tolerated and rapidly absorbed.
CLINICAL TRIAL REGISTRATION


2019-000898-23 (EudraCT); NCT03875937 (ClinicalTrials.gov).",2020,"The time to reach therapeutic concentrations (5 or 10 mg L -1 ) after a single intramuscular TXA 1 g injection are 4 or 11 min, with the time above these concentrations being 10 or 5.6 h, respectively.
","['two UK hospitals', 'bleeding trauma patients', 'Thirty bleeding trauma patients']","['Intramuscular TXA', 'intramuscular TXA', 'tranexamic acid (TXA', 'TXA', 'intramuscular tranexamic acid']","['bioavailability, 7.1 L h -1  for elimination clearance', 'time to reach therapeutic concentrations', 'bleeding deaths']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C2346686', 'cui_str': 'L/h'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.196912,"The time to reach therapeutic concentrations (5 or 10 mg L -1 ) after a single intramuscular TXA 1 g injection are 4 or 11 min, with the time above these concentrations being 10 or 5.6 h, respectively.
","[{'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Grassin-Delyle', 'Affiliation': 'Département de Biotechnologie de la Santé, Université Paris-Saclay, UVSQ, Inserm, Infection et inflammation, Montigny le Bretonneux, France; Département des Maladies des Voies Respiratoires, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Picetti', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Frimley', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jarman', 'Affiliation': ""Emergency Department Clinical Research Unit, St George's Hospital, London, UK.""}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Davenport', 'Affiliation': 'Emergency Department, The Royal London Hospital, London, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuinness', 'Affiliation': ""Emergency Department Clinical Research Unit, St George's Hospital, London, UK.""}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Moss', 'Affiliation': ""Emergency Department Clinical Research Unit, St George's Hospital, London, UK.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pott', 'Affiliation': 'Emergency Department, The Royal London Hospital, London, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Tai', 'Affiliation': 'Emergency Department, The Royal London Hospital, London, UK.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lamy', 'Affiliation': 'Département de Biotechnologie de la Santé, Université Paris-Saclay, UVSQ, Inserm, Infection et inflammation, Montigny le Bretonneux, France.'}, {'ForeName': 'Saïk', 'Initials': 'S', 'LastName': 'Urien', 'Affiliation': 'Unité de Recherche Clinique, Inserm, Hôpital Cochin-Necker, Université Paris Descartes, Sorbonne-Paris Cité, Paris, France.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Prowse', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thayne', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gilliam', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Pynn', 'Affiliation': 'Department of Research and Clinical Innovation, Royal Centre for Defence Medicine, Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Ian.Roberts@LSHTM.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.058']
2352,33010934,"[Effect of palonosetron, ondansetron and dexamethasone in the prevention of postoperative nausea and vomiting in video cholecystectomy with total venous anesthesia with propofol-remifentanil - randomized clinical trial].","INTRODUCTION AND OBJECTIVES


The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT 3  antagonists. This study aims to assess the effect of the 5-HT 3  antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia.
METHODS


Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol.
RESULTS


Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours.
CONCLUSIONS


The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.",2020,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","['patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia', 'video cholecystectomy with total venous anesthesia with', 'Sixty individuals who underwent']","['droperidol', 'ondansetron associated with 4\xa0mg of dexamethasone', 'propofol-remifentanil', 'video cholecystectomy', 'palonosetron', 'dexamethasone', 'propofol, remifentanil and rocuronium', '5-HT 3  antagonist', 'palonosetron, ondansetron and dexamethasone']","['PONV incidence', 'postoperative nausea and vomiting', 'PONV', 'Postoperative Nausea and Vomiting (PONV', 'superior nausea control', 'incidence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700654', 'cui_str': 'HTR3A protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0368543,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","[{'ForeName': 'Neuber Martins', 'Initials': 'NM', 'LastName': 'Fonseca', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Faculdade de Medicina, Disciplina de Anestesiologia, Uberlândia, MG, Brazil; Sociedade Brasileira de Anestesiologia (SBA), Comissão de Normas Técnicas, Brasil; CET-FMUF, Uberlândia, MG, Brasil; Coordinator of CE\xa026.06001 - Equipamento Respiratório e de Anestesia da ABNT and Delegate of ABNT no ISO/TC 121 - Anaesthetic and Respiratory Equipment, Uberlândia, MG, Brazil. Electronic address: neubermf@gmail.com.'}, {'ForeName': 'Ludmila Ribeiro', 'Initials': 'LR', 'LastName': 'Pedrosa', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Melo', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Uberlândia, MG, Brazil.'}, {'ForeName': 'Ricardo de Ávila', 'Initials': 'RÁ', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Departamento de Cirurgia, Disciplina de Cirurgia Vascular, Uberlândia, MG, Brazil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.08.001']
2353,33010968,"Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study.","OBJECTIVES


Painful sexual intercourse (dyspareunia) is a distressing condition affecting a large proportion of gynecological cancer survivors, yet treatments remain limited and poorly studied. This multicenter prospective interventional study examined the feasibility, acceptability and effects of multimodal pelvic floor physical therapy in gynecological cancer survivors with dyspareunia.
METHODS


Thirty-one endometrial and cervical cancer survivors with dyspareunia participated in 12 weekly 60-min physical therapy sessions combining education, manual therapy, pelvic floor muscle exercises using biofeedback and home exercises, which included the use of a dilator. The adherence rate to home exercises (≥80%), the attendance rate at physical therapy sessions (≥80% of participants attending ≥10 sessions) and the dropout rate (˂15%) served as feasibility and acceptability outcomes and benchmarks. Pain intensity, pain quality, sexual function, pelvic floor dysfunction symptoms and quality of life were measured at baseline and post-treatment. Treatment satisfaction and participants' perceived improvement were also assessed.
RESULTS


The adherence rate was 88% (SD 10), 29/31 (94%) women attended ≥10 treatment sessions, and the dropout rate was 3%. Moreover, women experienced significant improvements in all outcomes after the intervention (p ≤ 0.044). They also reported being highly satisfied with the treatment (9.3/10 (SD 1.2)), and 90% of them were very much or much improved.
CONCLUSIONS


Our findings support the feasibility and acceptability of multimodal pelvic floor physical therapy for gynecological cancer survivors with dyspareunia. The intervention also led to significant improvements in pain, sexual function, pelvic floor dysfunction symptoms and quality of life. A randomized controlled trial is needed to confirm these results.",2020,"The adherence rate to home exercises (≥80%), the attendance rate at physical therapy sessions (≥80% of participants attending ≥10 sessions) and the dropout rate (˂15%) served as feasibility and acceptability outcomes and benchmarks.","['gynecological cancer survivors suffering from painful sexual intercourse', 'gynecological cancer survivors with dyspareunia', 'Thirty-one', 'endometrial and cervical cancer survivors with dyspareunia participated in 12 weekly 60-min', 'Painful sexual intercourse (dyspareunia']","['physical therapy sessions combining education, manual therapy, pelvic floor muscle exercises using biofeedback and home exercises', 'multimodal pelvic floor physical therapy']","['feasibility and acceptability outcomes and benchmarks', 'pain, sexual function, pelvic floor dysfunction symptoms and quality of life', 'Pain intensity, pain quality, sexual function, pelvic floor dysfunction symptoms and quality of life', 'adherence rate', 'dropout rate', 'attendance rate', 'adherence rate to home exercises', 'Feasibility, acceptability and effects']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0437933,"The adherence rate to home exercises (≥80%), the attendance rate at physical therapy sessions (≥80% of participants attending ≥10 sessions) and the dropout rate (˂15%) served as feasibility and acceptability outcomes and benchmarks.","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Cyr', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada.'}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, University of Montreal, 7077 Park Avenue, Montreal, Quebec H3N 1X7, Canada; Research Center of the Institut Universitaire de Gériatrie de Montréal, 4545 Queen Mary, Montreal, Quebec H3W 1W6, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Research Center of the Centre Hospitalier Universitaire de Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Pina', 'Affiliation': ""Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Faculty of Medicine, University of Montreal, PO Box 6128 Centre-ville Station, Montreal, Quebec H3C 3J7, Canada; Research Center of the Centre Hospitalier de l'Université de Montréal, 900 Saint-Denis, Montreal, Quebec H2X 0A9, Canada.""}, {'ForeName': 'Walter Henry', 'Initials': 'WH', 'LastName': 'Gotlieb', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Faculty of Medicine, McGill University, 1001 Decarie Blvd, Montreal, Quebec H4A 3J1, Canada; Lady Davis Institute, Jewish General Hospital, 3755 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec H3T 1E2, Canada.'}, {'ForeName': 'Korine', 'Initials': 'K', 'LastName': 'Lapointe-Milot', 'Affiliation': 'Research Center of the Centre Hospitalier Universitaire de Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Research Center of the Centre Hospitalier de l'Université de Montréal, 900 Saint-Denis, Montreal, Quebec H2X 0A9, Canada; Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Faculty of Medicine, University of Montreal, PO Box 6128 Centre-ville Station, Montreal, Quebec H3C 3J7, Canada.""}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine and Health Sciences, University of Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, 3001 12e Avenue N, Sherbrooke, Quebec J1H 5N4, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.001']
2354,33010974,Androgens and hirsutism score of overweight women with polycystic ovary syndrome improved after vitamin D treatment: A randomized placebo controlled clinical trial.,"BACKGROUND & AIM


The objective of this study was to investigate the effect of vitamin D treatment on androgen levels and hirsutism scores in overweight women with PCOS.
METHODS


A prospective, randomized, double-blind, placebo-controlled clinical study was conducted at King Abdullah University Hospital in Irbid, Jordan. Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n = 60) were assigned to two groups: the treatment group (n = 30) who received 50,000 IU per week of vitamin D 3  and the control group (n = 30) who received a placebo.
RESULTS


After receiving the treatment for 12 consecutive weeks, the levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score were significantly decreased (P < 0.001), and the levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus were significantly increased (P < 0.05). Furthermore, significant changes were observed in ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle (P < 0.001). In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
CONCLUSION


Vitamin D 3  at a treatment dose of 50,000 IU per week improved 25(OH)D levels and decreased the hirsutism scores and androgen levels of overweight women with PCOS. These results could mean increased fertility and better reproductive health for overweight women with PCOS; the use of vitamin D 3  as a treatment for these patients should be further investigated. CLINICALTRIALS.
GOV REGESTRATION NUMBER


NCT02328404.",2020,"In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
","['overweight women with polycystic ovary syndrome', 'overweight women with PCOS', 'King Abdullah University Hospital in Irbid, Jordan', 'Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n\xa0=\xa060']","['vitamin D 3  and the control group (n\xa0=\xa030) who received a placebo', 'placebo', 'vitamin D treatment', 'vitamin D']","['levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus', '25(OH)D levels', 'levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score', 'fertility and better reproductive health', 'Androgens and hirsutism score', 'ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle', 'androgen levels, hirsutism score, or menstrual regularity', 'androgen levels and hirsutism scores', 'hirsutism scores and androgen levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0578772', 'cui_str': 'Hirsutism score'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",60.0,0.556511,"In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.
","[{'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Al-Bayyari', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Al-Huson University College, Al-Balqa Applied University, Al-Salt, Jordan. Electronic address: n.bayyari@bau.edu.jo.'}, {'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Al-Domi', 'Affiliation': 'Department of Nutrition and Food Technology, Faculty of Agriculture, Jordan University, Amman, Jordan.'}, {'ForeName': 'Faheem', 'Initials': 'F', 'LastName': 'Zayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': ""Ra'ed"", 'Initials': 'R', 'LastName': 'Hailat', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Arieanna', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Department of Integrated Physiology and Health Sciences, Alma College, Alma, MI, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.09.024']
2355,33010985,Prostate-specific Antigen Progression in Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer: Any Rise in Prostate-specific Antigen May Require Closer Monitoring.,"BACKGROUND


There is no universally accepted definition for prostate-specific antigen (PSA) progression. However, changes in PSA in patients with castration-resistant prostate cancer (CRPC) are used to inform treatment decisions.
OBJECTIVE


To determine whether the Prostate Cancer Working Group 2 (PCWG2) definition of PSA progression is adequate to predict radiographic or clinical progression in enzalutamide-treated men with nonmetastatic CRPC (nmCRPC).
DESIGN, SETTING, AND PARTICIPANTS


A post hoc, retrospective analysis of men with nmCRPC from PROSPER (NCT02003924) was performed.
INTERVENTION


Continued androgen deprivation therapy; patients randomized 2:1 to enzalutamide 160 mg/d or placebo.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Metastasis-free survival (MFS) in men with and without PSA progression, defined by PCWG2, and PSA at the time of radiographic progression were assessed.
RESULTS AND LIMITATIONS


As of June 28, 2017, in enzalutamide-treated patients, the risk of metastasis or death was increased significantly in those with PSA progression versus those without (hazard ratio [HR] 3.99; 95% confidence interval [CI], 2.95-5.41; p < 0.0001). Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression. In placebo-treated patients, PSA progression was not significantly associated with MFS (HR 1.72; 95% CI, 0.86-3.45; p = 0.1). Median MFS was NR (95% CI, 25.6-NR) in patients without PSA progression and 18.3 mo (95% CI, 14.9-19.4) in those with PSA progression. The median PSA increase from nadir at the time of radiographic progression was 1.4 ng/mL in enzalutamide-treated men and 25.6 ng/mL for the placebo arm.
CONCLUSIONS


In men with nmCRPC and rapidly rising PSA, radiographic progression often occurred without PCWG2-defined PSA progression, suggesting that any increase in PSA may warrant closer monitoring. While PCWG2-defined PSA progression was associated with radiographic progression in enzalutamide-treated men, our findings argue for prospective re-evaluation of this threshold.
PATIENT SUMMARY


In this report, we looked at changes in prostate-specific antigen (PSA) in enzalutamide-treated men with nonmetastatic castration-resistant prostate cancer who no longer respond to testosterone-lowering treatment. We found that even very small changes in PSA while on treatment could be an early indication of disease progression and should trigger closer monitoring.",2020,"Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression.","['men with nmCRPC from PROSPER (NCT02003924) was performed', 'Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer', 'enzalutamide-treated men with nonmetastatic CRPC (nmCRPC', 'patients with castration-resistant prostate cancer (CRPC', 'treated men with nonmetastatic castration-resistant prostate cancer who no longer respond to testosterone-lowering treatment']","['enzalutamide 160\u2009mg/d or placebo', 'enzalutamide', 'placebo']","['prostate-specific antigen (PSA', 'PCWG2, and PSA at the time of radiographic progression', 'risk of metastasis or death', 'PSA progression', 'Metastasis-free survival (MFS', 'Median MFS', 'median PSA increase from nadir at the time of radiographic progression', 'radiographic progression']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.203154,"Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression.","[{'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center (CHUM), Montreal, QC, Canada. Electronic address: fred.saad@umontreal.ca.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'University of Paris Saclay, Villejuif, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc., La Jolla, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Noerby', 'Affiliation': 'Sygehus, Lillebælt, Vejle, Denmark.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}]",European urology,['10.1016/j.eururo.2020.08.025']
2356,33010998,A quasi-experimental evaluation of advance care planning improves consistency between elderly individuals and their surrogates regarding end-of-life care preferences: Development and application of a decision aid with cartoon pictures.,"OBJECTIVE


This study sought to develop a decision aid with cartoon pictures and evaluate its effectiveness in increasing consistency between elderly individuals and their surrogates regarding end-of-life care.
METHODS


A pre-post quasi-experimental design was adopted using the Life Support Preferences Questionnaire. The intervention had two components: (1) increasing participants' knowledge of medical treatments related to end-of-life care, and (2) sharing their end-of-life wishes. The experimental group received an intervention, whereas the control group received usual care.
RESULTS


A total of 110 participants in 55 pairs of elderly individuals with average aged 86.4 and their surrogates (27 in the experimental group, 28 in the control group) were recruited from a veterans hospital in northern Taiwan. Nearly 90 % of elderly individuals were male. The multiple linear regression showed that the inconsistent gap between elderly individuals and their surrogates in the experimental group decreased 12 points than the control group after controlling the covariances (B = -12.116, p = 0.032).
CONCLUSION


The intervention improved the consistency between elderly individuals and their surrogates regarding end-of-life care.
PRACTICE IMPLICATIONS


A decision aid with cartoon pictures may support the discussion of end-of-life care in older Asian populations.",2020,"The multiple linear regression showed that the inconsistent gap between elderly individuals and their surrogates in the experimental group decreased 12 points than the control group after controlling the covariances (B = -12.116, p = 0.032).
","['older Asian populations', 'elderly individuals and their surrogates regarding end-of-life care', '110 participants in 55 pairs of elderly individuals with average aged 86.4 and their surrogates (27 in the experimental group, 28 in the control group) were recruited from a veterans hospital in northern Taiwan']","['control group received usual care', 'advance care planning']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020030', 'cui_str': 'Veterans Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],110.0,0.0184386,"The multiple linear regression showed that the inconsistent gap between elderly individuals and their surrogates in the experimental group decreased 12 points than the control group after controlling the covariances (B = -12.116, p = 0.032).
","[{'ForeName': 'Li-Shan', 'Initials': 'LS', 'LastName': 'Ke', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, School of Nursing, Taipei, Taiwan; Taipei Veterans General Hospital, Department of Nursing, Taipei, Taiwan; National Taiwan University, College of Medicine, School of Nursing, Taipei, Taiwan. Electronic address: lishan@ntunhs.edu.tw.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'National Taiwan University, College of Medicine, School of Nursing, Taipei, Taiwan; National Taiwan University Hospital, Department of Nursing, Taipei, Taiwan.'}, {'ForeName': 'Ching-Yu', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'National Taiwan University, College of Medicine, Taipei, Taiwan; National Taiwan University Hospital, Department of Family Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chieh-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, Department of Speech Language Pathology and Audiology, Taipei, Taiwan.'}, {'ForeName': 'Tai-Yuan', 'Initials': 'TY', 'LastName': 'Chiu', 'Affiliation': 'National Taiwan University, College of Medicine, Taipei, Taiwan; National Taiwan University Hospital, Department of Family Medicine, Taipei, Taiwan.'}]",Patient education and counseling,['10.1016/j.pec.2020.09.027']
2357,33011010,Results of a Family-Based Intervention Promoting Healthy Weight Strategies in Overweight Hispanic Adolescents and Parents: An RCT.,"INTRODUCTION


Hispanic adolescents in the U.S. are disproportionately affected by overweight and obesity compared with their White, non-Hispanic counterparts. This study examines the efficacy of an evidence-based family intervention adapted to target obesity-related outcomes among Hispanic adolescents who were overweight/obese compared with prevention as usual.
STUDY DESIGN


This study was an RCT.
SETTING/PARTICIPANTS


Participants were Hispanic adolescents who were overweight/obese (n=280, mean age=13.01 [SD=0.82] years) in the 7th/8th grade and their primary caregivers. Primary caregivers were majority female legal guardians (88% female, mean age=41.88 [SD=6.50] years).
INTERVENTION


Participants were randomized into the family-level obesity-targeted intervention or referral to community services offered for overweight/obese adolescents and families (condition). Data collection began in 2015.
MAIN OUTCOME MEASURES


Primary outcomes included dietary intake (e.g., reduction of sweetened beverages) and past-month moderate-to-vigorous physical activity. Secondary outcomes were BMI and family functioning assessed among adolescents and primary caregivers.
RESULTS


Study analyses (2019) indicated no significant intervention effects for adolescents' primary outcomes. Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention. Intervention effects were found for adolescent family communication (β=0.13, 95% CI=0.02, 0.24), peer monitoring (β=0.12, 95% CI=0.01, 0.23), and parental involvement (β=0.16, 95% CI=0.06, 0.26) at 6 months after baseline compared with prevention as usual.
CONCLUSIONS


This intervention was not effective in improving overweight/obesity-related outcomes in adolescents. The intervention was effective in improving parents' dietary intake and BMI; however, the effects were not sustained in the long term. Other intervention strategies (e.g., booster sessions, increased nutritional information) may be necessary to sustain beneficial effects and extend effects to adolescent participants.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03943628.",2020,"Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention.","['adolescent participants', 'Hispanic adolescents who were overweight/obese compared with prevention as usual', 'Overweight Hispanic Adolescents and Parents', 'Hispanic adolescents', 'Participants were Hispanic adolescents who were overweight/obese']","['Family-Based Intervention Promoting Healthy Weight Strategies', 'family-level obesity-targeted intervention or referral to community services offered for overweight/obese adolescents and families (condition', 'evidence-based family intervention']","['BMI', 'BMI and family functioning assessed among adolescents and primary caregivers', ""parents' dietary intake and BMI"", ""parents' intake of fresh fruits and vegetables"", 'majority female legal guardians', 'dietary intake (e.g., reduction of sweetened beverages) and past-month moderate-to-vigorous physical activity', 'adolescent family communication']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4040088', 'cui_str': 'Referral to community service'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453268', 'cui_str': 'Fresh fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.132731,"Intervention effects were found for parents' intake of fresh fruits and vegetables (β=0.12, 95% CI=0.02, 0.23), added sugar (β= -0.11, 95% CI= -0.22, -0.004), and sweetened beverages (β= -0.12, 95% CI=-0.23, -0.02), and parents showed decreased BMI (β= -0.05, 95% CI= -0.11, -0.01) at 6 months after baseline compared with usual prevention.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida. Electronic address: gprado@miami.edu.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami, Miami, Florida.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tapia', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Velazquez', 'Affiliation': 'School of Nursing and Health Studies, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': ""Department of Public Health Sciences, University of Miami, Miami, Florida; Department of Pediatrics, Miller School of Medicine, University of Miami, Miami, Florida; University of Texas Health Science Center, School of Public Health, Dallas, Texas; Center for Pediatric Population Health, UTHealth School of Public Health and Children's Health System of Texas, Dallas, Texas.""}]",American journal of preventive medicine,['10.1016/j.amepre.2020.06.010']
2358,33011059,Effect of low dose robotic-gait training on walking capacity in children and adolescents with cerebral palsy.,"OBJECTIVE


Robotic gait training presents a promising training modality. Nevertheless, evidence supporting the efficacy of such therapy in children with cerebral palsy remains insufficient. This study aimed to assess the effect of robotic gait training in children/adolescents with cerebral palsy.
METHODS


Twenty-four children/adolescents with bilateral cerebral palsy (12 female, 10.1 ± 3.1 years, Gross Motor Function Classification System II to IV) took part in this study. They received two 30-45 min sessions/week of Lokomat training for 12-weeks. Muscle strengths, 6-min walk exercise and gait parameters were evaluated pre- and post-training and at 6-months-follow-up. Training effect according to the level of impairment severity (moderate vs severe) was analyzed using a change from the baseline procedure.
RESULTS


A significant increase in muscle strength was observed after training (p ≤ 0.01). Hip flexors and knee extensors strength changes were maintained or improved at follow-up (p < 0.05). Comfortable walking speed was significantly increased by +20% after training with a slight reduction at follow-up compared to post-training condition (-2.7%, p < 0.05). A significant step length increase was observed after training (14%, p ≤ 0.001). The distance covered in 6 min was higher in post-training (+24%, p ≤ 0.001) and maintained at follow-up compared to pre-training conditions. No significant changes in kinematic patterns were observed. The analysis by subgroup showed that both groups of children (with moderate and severe impairments) improved muscle strength and walking capacities after Lokomat training.
CONCLUSION


The suggested Lokomat training induced improvement in walking capacity of children/adolescents with cerebral palsy whatever the level of severity. Hence, Lokomat training could be viewed as a valuable training modality in this population.",2020,"The distance covered in 6 min was higher in post-training (+24%, p ≤ 0.001) and maintained at follow-up compared to pre-training conditions.","['Twenty-four children/adolescents with bilateral cerebral palsy (12 female, 10.1\u202f±\u202f3.1 years, Gross Motor Function Classification System II to IV) took part in this study', 'children and adolescents with cerebral palsy', 'children with cerebral palsy', 'children/adolescents with cerebral palsy']","['low dose robotic-gait training', 'Lokomat training for 12-weeks. Muscle strengths, 6-min walk exercise and gait parameters were evaluated pre- and post-training and at 6-months-follow-up', 'Robotic gait training', 'robotic gait training', 'Lokomat training']","['muscle strength and walking capacities', 'muscle strength', 'walking capacity', 'step length increase', 'Hip flexors and knee extensors strength changes', 'kinematic patterns', 'Comfortable walking speed']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",24.0,0.0164289,"The distance covered in 6 min was higher in post-training (+24%, p ≤ 0.001) and maintained at follow-up compared to pre-training conditions.","[{'ForeName': 'Yosra', 'Initials': 'Y', 'LastName': 'Cherni', 'Affiliation': ""École de Kinésiologie et des Sciences de L'Activité Physique, Faculté de Médecine, Université de Montréal, 2100, Boul. Édouard-Montpetit, H3T 1J4 Montréal, Québec, Canada; Centre de Recherche du Centre de Réadaptation Marie-Enfant, CHU Sainte-Justine, 5200 Rue Bélanger, H1T 1C9 Montréal, Québec, Canada. Electronic address: yosra.cherni@umontreal.ca.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ballaz', 'Affiliation': ""Centre de Recherche du Centre de Réadaptation Marie-Enfant, CHU Sainte-Justine, 5200 Rue Bélanger, H1T 1C9 Montréal, Québec, Canada; Département des Sciences de L'Activité Physique, Université de Québec à Montréal, C.P. 8888, Succursale Centre-Ville, H3C 3P8 Montréal, Québec, Canada.""}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Lemaire', 'Affiliation': 'Centre de Recherche du Centre de Réadaptation Marie-Enfant, CHU Sainte-Justine, 5200 Rue Bélanger, H1T 1C9 Montréal, Québec, Canada.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Dal Maso', 'Affiliation': ""École de Kinésiologie et des Sciences de L'Activité Physique, Faculté de Médecine, Université de Montréal, 2100, Boul. Édouard-Montpetit, H3T 1J4 Montréal, Québec, Canada.""}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Begon', 'Affiliation': ""École de Kinésiologie et des Sciences de L'Activité Physique, Faculté de Médecine, Université de Montréal, 2100, Boul. Édouard-Montpetit, H3T 1J4 Montréal, Québec, Canada; Centre de Recherche du Centre de Réadaptation Marie-Enfant, CHU Sainte-Justine, 5200 Rue Bélanger, H1T 1C9 Montréal, Québec, Canada.""}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.09.005']
2359,33011095,Cognitive Function Improvements Mediate Exercise Intervention Effects on Physical Performance in Acutely Hospitalized Older Adults.,"OBJECTIVES


An individualized, multicomponent exercise program is effective to reverse the functional and cognitive decline that frequently occur during acute care hospitalization in older patients. The aim was to determine whether improvements in cognition mediate improvements in physical function in acutely hospitalized older patients.
DESIGN


A single-center, single-blind randomized clinical trial.
SETTING AND PARTICIPANTS


Acute care for elderly (ACE) unit in a tertiary public hospital in Navarre (Spain). Hospitalized patients were randomly assigned to an exercise intervention (n = 185) or usual-care group (n = 185). The intervention consisted of a multicomponent exercise-training program performed during 5 to 7 consecutive days (2 sessions/day). The usual-care group received habitual hospital care, which included physical rehabilitation when needed.
MEASURES


The main endpoints were changes in cognitive function assessed by the Mini-Mental State Examination test and verbal fluency ability, and changes in physical performance by the Short Physical Performance Battery from baseline to discharge. Mediation regression models were generated using ordinary least squares with the PROCESS version 3.2 to determine links between exercise-induced improvements.
RESULTS


Mediation regression model analysis indicated a significant and direct beneficial effect of physical exercise on physical function (β = 2.14; P < .0001), and a significant indirect effect of global cognitive function on the direct effect (indirect effect = 0.26; 0.10 to 0.49). Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function.
CONCLUSIONS AND IMPLICATIONS


Cognitive function enhancements mediate physical function improvements in acutely hospitalized older adults after an individualized, multicomponent exercise-training program. ClinicalTrials.gov registration (NCT02300896).",2020,"Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function.
","['acutely hospitalized older patients', 'acutely hospitalized older adults', 'older patients', 'Acutely Hospitalized Older Adults', 'Hospitalized patients', 'Acute care for elderly (ACE) unit in a tertiary public hospital in Navarre (Spain']","['multicomponent exercise program', 'exercise-training', 'exercise intervention', 'multicomponent exercise-training program', 'Cognitive Function Improvements Mediate Exercise Intervention', 'usual-care group', 'habitual hospital care, which included physical rehabilitation when needed']","['Physical Performance', 'global cognitive function', 'cognitive function assessed by the Mini-Mental State Examination test and verbal fluency ability, and changes in physical performance by the Short Physical Performance Battery', 'Verbal fluency ability', 'physical function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",185.0,0.0243896,"Verbal fluency ability also had an indirect effect (0.32; 0.16 to 0.53) on the positive effect of exercise-training on physical function.
","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; Laboratorio de Ciencias de la Actividad Física, el Deporte y la Salud, Universidad de Santiago de Chile, USACH, Santiago, Chile.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mikel.izquierdo@gmail.com.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.024']
2360,33011099,"Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis.","BACKGROUND


Few therapies specifically address the chronic airway inflammation in cystic fibrosis (CF) that contributes to progressive destruction of lung tissue and loss of lung function. Lenabasum is a cannabinoid type 2 receptor (CB2) agonist that resolves inflammation in a number of in vitro and in vivo models.
METHODS


A Phase 2 double-blind, randomized, placebo-controlled study assessed the safety and tolerability of lenabasum in adults with CF. Subjects with FEV 1 % (ppFEV 1 ) ≥40% predicted were randomized to lenabasum 1 or 5 mg or placebo once daily (QD) (Weeks 1-4), then 20 mg QD, 20 mg twice daily (BID) or placebo (Weeks 5-12), with follow-up at Week 16. Pulmonary exacerbations (PEx) were recorded and biomarkers of blood and lung inflammation were measured.
RESULTS


Of 89 subjects randomized, 51 lenabasum and 23 placebo-only subjects completed the study. No deaths or serious or severe adverse events (AE) were considered related to lenabasum. Most AEs were mild/moderate, and the most common were PEx, hemoptysis, dry mouth, and upper respiratory infection. Three lenabasum and one placebo-only subjects discontinued the study for a treatment related AE. New PEx were treated with intravenous antibiotics in 4.0% of lenabasum-treated vs. 11.4% of placebo-treated subjects, during Weeks 1-4 and 5.2% compared to 13.0% during Weeks 5-12 (p<0.2). No significant differences in ppFEV1 were observed between treatment groups. Sputum neutrophils, eosinophils, and neutrophil elastase were numerically reduced, and significant (p<0.05) reductions in IL-8 and immunoglobulin G levels occurred with lenabasum.
CONCLUSIONS


The safety findings of lenabasum, coupled with biomarker data, support further testing in a larger study with a longer duration.",2020,"Sputum neutrophils, eosinophils, and neutrophil elastase were numerically reduced, and significant (p<0.05) reductions in IL-8 and immunoglobulin G levels occurred with lenabasum.
","['Subjects with FEV 1 % (ppFEV 1 ) ≥40% predicted were randomized to', '89 subjects randomized, 51 lenabasum and 23', 'adults with cystic fibrosis', 'adults with CF', 'cystic fibrosis (CF']","['intravenous antibiotics', 'placebo', 'lenabasum', 'lenabasum 1 or 5\xa0mg or placebo once daily (QD']","['IL-8 and immunoglobulin G levels', 'PEx, hemoptysis, dry mouth, and upper respiratory infection', 'Safety and efficacy', 'ppFEV1', 'Sputum neutrophils, eosinophils, and neutrophil elastase', 'blood and lung inflammation', 'deaths or serious or severe adverse events (AE', 'safety and tolerability of lenabasum', 'Pulmonary exacerbations (PEx']","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",89.0,0.338751,"Sputum neutrophils, eosinophils, and neutrophil elastase were numerically reduced, and significant (p<0.05) reductions in IL-8 and immunoglobulin G levels occurred with lenabasum.
","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Chmiel', 'Affiliation': 'Riley Hospital for Children at IU Health, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: jfchmiel@iu.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Flume', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Damian G', 'Initials': 'DG', 'LastName': 'Downey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Dozor', 'Affiliation': 'New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Mazurek', 'Affiliation': 'Department of Pneumonology and Cystic Fibrosis, Institute of Tuberculosis and Lung Disease, Rabka-Zdrój, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sapiejka', 'Affiliation': 'Institute of Mother and Child, Department of Cystic Fibrosis for Children and Youth, Gdańsk, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rachel', 'Affiliation': 'University of Rzeszow, Rzeszów, Poland.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Constantine', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Conley', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dgetluck', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Quinn', 'Initials': 'Q', 'LastName': 'Dinh', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': ""Imperial College and Royal Brompton Hospital, London, and Queen's University, Belfast, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.09.008']
2361,33011163,Does Dynamic Intermaxillary Fixation With Elastics Improve Outcomes Following Unilateral Condylar Fracture?,"PURPOSE


The use of rigid versus semi-rigid intermaxillary fixation (IMF) following subcondylar fractures is controversial. This study aims to investigate whether the ""dynamic"" elastic fixation technique improves the outcomes, comparing to the rigid fixation technique for the treatment of displaced subcondylar fractures in adults.
MATERIALS AND METHODS


This nonblinded randomized clinical trial was performed on adult patients with unilateral displaced mandibular subcondylar fractures. Patients were randomly allocated into two groups (n = 17). The primary predictor variable was wire versus elastic IMF. Changes in primary (mouth opening) and secondary (other clinical and radiological) outcomes were recorded. Data analyzed with the t test and Mann-Whitney test with SPSS software version 20. P-value < .05 considered as significant.
RESULTS


In this study 34 patients (with mean age of 33.03 ± 1.79, 23.5% females & 76.5% males) in two groups (Elastics & Wire) followed up to 6 months. The Elastics group showed significant improvement in mouth opening (primary outcome) after one month of follow up, but the differences were not significant at the end of the study. In terms of secondary outcomes, the ramus height shortening compared to the opposite side revealed favorable improvement in the Elastics group in the period of study. The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group. The differences in pain, fracture displacement, and midline deviation between study groups were not significant at the end of the study. Just one case with malocclusion observed in the Wire group. Patients were more satisfied with dynamic nonrigid IMF with elastics.
CONCLUSIONS


The results of this study showed that using the dynamic IMF technique is more tolerable, and patients have better functional and clinical outcomes during and at the end treatment.",2020,The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group.,"['displaced subcondylar fractures in adults', '34 patients (with mean age of 33.03\xa0±\xa01.79, 23.5% females & 76.5% males) in two groups (Elastics & Wire) followed up to 6\xa0months', 'adult patients with unilateral displaced mandibular subcondylar fractures']","['dynamic"" elastic fixation technique', 'rigid fixation technique', 'dynamic IMF technique', 'rigid versus semi-rigid intermaxillary fixation (IMF']","['mouth opening', 'pain, fracture displacement, and midline deviation', 'ramus height shortening', 'lateral movement and protrusive movement', 'wire versus elastic IMF']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]","[{'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0399532', 'cui_str': 'Midline deviation of dental arch'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",34.0,0.0216468,The differences between the two groups in the lateral movement and protrusive movement were significant in favor of the Elastics group.,"[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khiabani', 'Affiliation': 'Associate professor, Department of Oral & Maxillofacial surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Zinhaghayegh', 'Affiliation': 'Assistant professor, Department of oral and maxillofacial surgery, Tabriz branch Islamic Azad University, Tabriz, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Amirzade-Iranaq', 'Affiliation': 'Researcher, Universal Network of Interdisciplinary Research in Oral and Maxillofacial Surgery (UNIROMS), Universal Scientific Education and Research Network (USERN), Tehran, Iran; Department head, Department of Research, Arka Education and Clinical Research Consultants, Tehran, Iran. Electronic address: h.amirzade@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.040']
2362,33011188,The influence of linguistic information on cortical tracking of words.,"Speech is a complex sound sequence that has rich acoustic and linguistic structures. Recent studies have suggested that low-frequency cortical activity can track linguistic units in speech, such as words and phrases, on top of low-level acoustic features. Here, with an artificial word learning paradigm, we investigate how different aspects of linguistic information, e.g., phonological, semantic, and orthographic information, modulate cortical tracking of words. Participants are randomly assigned to the experimental group or the control group. Both groups listen to speech streams composed of trisyllabic artificial words or trisyllabic real words. Participants in the experimental group explicitly learn different types of linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words. Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words. However, when comparing the experimental and control groups, we find that explicit learning significantly improves neural tracking of artificial words. After explicit learning, cortical tracking of artificial words is comparable to real words, regardless of the training conditions. These results suggest training facilitates neural tracking of words and emphasize the basic role phonological information played in sequential grouping.",2020,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,[],"['linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words', 'explicit learning']",['neural tracking of artificial words'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0216826,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, China, 310027.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, China, 310027.'}, {'ForeName': 'Nai', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, China, 310027; Research Center for Advanced Artificial Intelligence Theory, Zhejiang Lab, Hangzhou, China, 311121. Electronic address: ding_nai@zju.edu.cn.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107640']
2363,33011202,Randomized Controlled Trial of a Novel Communication Device Assessed during Noninvasive Ventilation Therapy.,"BACKGROUND


Noninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol.
STUDY DESIGN AND METHODS


A single-center RCT (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cmH2O and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort.
RESULTS


While conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%) respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%, p < 0.001) and by 126% (33% vs 76%, p < 0.001) higher than the control arm respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, p= 0.042) and partner-perceived comfort by relatively 245% (20% vs 69%, p= 0.0074).
INTERPRETATION


Use of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03795753.",2020,"The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, p= 0.042) and partner-perceived comfort by relatively 245% (20% vs 69%, p= 0.0074).
","['A single-center RCT (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cmH2O and PAP communication devices (SPEAX, Ataia Medical']","['Novel Communication Device Assessed during Noninvasive Ventilation Therapy', 'baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device', 'Noninvasive ventilation (NIV', 'CPAP therapy', 'positive airway pressure (PAP) therapy']","['Communication impairment', 'PAP, word and sentence intelligibility', 'device improved outpatient-perceived PAP comfort', 'partner-perceived comfort', 'Word and sentence intelligibility', 'intelligibility and comfort']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",36.0,0.108308,"The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, p= 0.042) and partner-perceived comfort by relatively 245% (20% vs 69%, p= 0.0074).
","[{'ForeName': 'An-Kwok', 'Initials': 'AK', 'LastName': 'Ian Wong', 'Affiliation': 'Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine; Emory University Department of Medicine. Electronic address: aiwong@emory.edu.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Cheung', 'Affiliation': 'Emory University Department of Medicine.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Emory University Department of Medicine.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Emory University Department of Biostatistics and Bioinformatics.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kutner', 'Affiliation': 'Emory University Department of Biostatistics and Bioinformatics.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Gay', 'Affiliation': 'Mayo Clinic Division of Pulmonary, Critical Care, and Sleep Medicine.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Collop', 'Affiliation': 'Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine; Emory University Department of Medicine.'}]",Chest,['10.1016/j.chest.2020.09.250']
2364,33011207,Randomised trial of external-beam radiotherapy alone or with high-dose-rate brachytherapy for prostate cancer: mature 12-year results.,"BACKGROUND AND PURPOSE


A randomised phase-III trial compared external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb) in localised prostate adenocarcinoma. Previous analysis, at median follow up of 85 months, demonstrated improved relapse free survival (RFS) with EBRT+HDR-BTb. This data has now been updated with a median follow up of 131 months.
MATERIALS AND METHODS


From December 1997 to August 2005, patients were assigned either to EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 x 8·5 Gy over 24h. The primary endpoint was RFS defined by a PSA rise ≥ 2.0µg/l above nadir, clinical progression or death. Actuarial survival rates and Hazard Ratios (HRs) were calculated using the Kaplan-Meier method and Cox's Proportional Hazard Model, respectively. Secondary endpoints were overall survival (OS), urinary and bowel toxicity.
RESULTS


106 patients received EBRT alone and 110 EBRT+HDR-BTb. Median time to relapse was 137 months in the HDR-BTb arm compared to 82 months for EBRT alone (p = 0·01). A 29% risk of recurrence with EBRT alone was observed (p = 0·001), resulting in a 21% improvement in RFS at 12 years with EBRT + HDR-BTb. In multivariate analysis treatment arm, risk category and no androgen deprivation therapy were significant covariates for risk of relapse. Differences in overall survival were not significant.
CONCLUSION


At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.",2020,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"['localised prostate adenocarcinoma', 'prostate cancer', '106 patients received', 'From December 1997 to August 2005, patients']","['external beam radiotherapy (EBRT) alone with EBRT combined with high-dose-rate brachytherapy boost (HDR-BTb', 'EBRT alone delivering 55 Gy in 20 fractions over 4 weeks or EBRT followed by a temporary high-dose-rate implant delivering 2 x 8·5 Gy over 24h', 'EBRT alone and 110 EBRT+HDR-BTb', 'external-beam radiotherapy alone or with high-dose-rate brachytherapy']","['overall survival (OS), urinary and bowel toxicity', 'overall survival', 'RFS defined by a PSA rise ≥ 2.0µg/l above nadir, clinical progression or death', 'severe late urinary and bowel events and urethral strictures', 'relapse free survival (RFS', 'Actuarial survival rates and Hazard Ratios (HRs', 'Median time to relapse', 'RFS']","[{'cui': 'C0007112', 'cui_str': 'Adenocarcinoma of prostate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730225', 'cui_str': '1997'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0962728,At 12 years there remains a significant improvement in RFS after EBRT + HDR-BTb; both treatments were equitoxic for severe late urinary and bowel events and urethral strictures.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK; University of Manchester, Manchester, UK. Electronic address: peterhoskin@nhs.net.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Rojas', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Ostler', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bryant', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK.'}, {'ForeName': 'Gerry J', 'Initials': 'GJ', 'LastName': 'Lowe', 'Affiliation': 'Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.047']
2365,33011293,"An invited commentary on: ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection."" (Int J Surg 2020; 81:140-146).",,2020,,[],['gentamicin-saline solution versus saline solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.233394,,"[{'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Chiarello', 'Affiliation': 'Department of Surgery, General Surgery Operative Unit, ""San Giovanni di Dio"" Hospital, Crotone, Italy. Electronic address: mikikr2001@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Brisinda', 'Affiliation': 'Department of Surgery, Catholic School of Medicine, ""Agostino Gemelli"" Hospital, Rome, Italy. Electronic address: gbrisin@tin.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.047']
2366,33011399,Effectiveness of single versus multiple episodes of photodynamic therapy as adjunct to scaling and root planing on periodontopathogenic bacteria in patients with periodontitis.,"OBJECTIVE


The aim of the present 6-months' follow-up study was to assess the influence of single versus multiple episodes of photodynamic therapy (PDT) as adjunct to scaling and root planning (SRP) on periodontopathogenic bacteria in patients with periodontitis.
METHODS


Forty-five patients with periodontitis were included. The patients were randomly divided into 3 groups. In groups 1 (n = 15), 2 (n = 15) and 3 (n = 15), the patients under went SRP with PDT at (a) baseline; (b) baseline and after 1-month; and (c) baseline and after 1- and 3-months. Peri-implant plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment loss (CAL) and marginal bone loss (MBL) were measured at baseline and 6-months follow-up. Counts of Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Aggregatibacter Actinomycetemcomitans were determined before SRP and at 4- and 6-months follow-up.
RESULTS


All patients had grade-B periodontitis. There was no statistically significant difference in age and gender in all groups. At- 6-months' follow-up, patients that underwent SRP once showed significantly higher counts of periodontopathogenic bacteria in the oral biofilm compared with patients that received photobiomodulation twice or three times (P < 0.05). There was no significant difference in the periodontal parameters and counts of gram-negative bacteria in patients that received photobiomodulation 2 or 3 times.
CONCLUSION


At least 2 sessions of photobiomodulation followed by baseline SRP is essential to achieve a significant reduction in the counts of subgingival bacteria in periodontitis patients over a 6-month follow-up period.",2020,"There was no significant difference in the periodontal parameters and counts of gram-negative bacteria in patients that received photobiomodulation 2 or 3 times.
","['patients with periodontitis', 'periodontitis patients', 'Forty-five patients with periodontitis were included', 'All patients had grade-B periodontitis']","['scaling and root planning (SRP', 'photodynamic therapy', 'photodynamic therapy (PDT']","['Peri-implant plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment loss (CAL) and marginal bone loss (MBL', 'periodontopathogenic bacteria', 'Counts of Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Aggregatibacter Actinomycetemcomitans', 'counts of subgingival bacteria', 'periodontal parameters and counts of gram-negative bacteria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0242938', 'cui_str': 'Prevotella intermedia'}, {'cui': 'C0085479', 'cui_str': 'Fusobacterium nucleatum'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}]",45.0,0.0286723,"There was no significant difference in the periodontal parameters and counts of gram-negative bacteria in patients that received photobiomodulation 2 or 3 times.
","[{'ForeName': 'Muzaheed', 'Initials': 'M', 'LastName': 'Muzaheed', 'Affiliation': 'Department of Clinical Laboratory Science, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. Electronic address: marasheed@iau.edu.sa.'}, {'ForeName': 'Sadananda', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Department of Public Health, College of Public Health, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Abdulrahim Refdan', 'Initials': 'AR', 'LastName': 'Hakami', 'Affiliation': 'Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, King Khalid University, Abha 61481, Saudi Arabia.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Allemailem', 'Affiliation': 'Department of Medical Laboratories, College of Applied Medical Sciences, Qassim University, Buraydah, Saudi Arabia.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alqahtani', 'Affiliation': 'King Abdulaziz Medical City, NGHA, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Al Saffan', 'Affiliation': 'Preventive Department, College of Dentistry, Riyadh Elm University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahad M', 'Initials': 'FM', 'LastName': 'Aldakheel', 'Affiliation': 'Department of Clinical Laboratory Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': 'Dental Biomaterials Research Chair, Dental Health Department, College of Applied Medical Sciences, King Saud University, P. O. Box: 10219, Riyadh 11433, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102035']
2367,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2020,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
2368,33011482,Combined utility of blood glucose and white blood cell in predicting outcome after acute ischemic stroke: The ENCHANTED trial.,"BACKGROUND


As hyperglycemia and leukocytosis individually predict poor outcome in acute ischemic stroke (AIS), we aimed to determine the significance of their combination on functional outcome and symptomatic intracerebral hemorrhage (sICH) among participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


Post-hoc analyzes of the full ENCHANTED cohort, an international, multicenter, quasi-factorial, randomized, open, blinded outcome-assessed trial of low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment in 4557 thrombolysis-eligible and treated AIS patients. Patients were divided into four groups according to baseline blood glucose and white blood cells (WBC) levels: A (normal glucose + WBC), B (hyperglycemia + normal WBC), C (normal glucose + high WBC), and D (hyperglycemia + high WBC). Logistic regression models were used to determine associations of each group and poor functional outcome (modified Rankin scale scores 2-6) at 90 days and sICH within 48 h, adjusted for confounders. Quality of model fit was examined with Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test.
RESULTS


Of 4181 AIS patients included in analyzes, and with group A as the reference, an increasing odds of poor functional outcome was evident across groups B (odds ratio [OR] 1.38, 95 % confidence interval [CI] 1.17-1.63), C (OR 1.26, 95 %CI 0.99-1.60), and D (OR 2.26, 95 %CI 1.79-2.85) (P trend <0.001). Group D patients also had a higher rate of sICH (P trend <0.05). The model fit with the combination of blood glucose and WBC was better than models of their individual components.
CONCLUSIONS


Using a combination of blood glucose and WBC provides strong prognostic significance than either alone in thrombolyzed AIS patients.",2020,Group D patients also had a higher rate of sICH (P trend <0.05).,"['4557 thrombolysis-eligible and treated AIS patients', 'participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED', 'acute ischemic stroke', '4181 AIS patients', 'acute ischemic stroke (AIS', 'thrombolyzed AIS patients']","['low- versus standard-dose intravenous alteplase and early intensive versus standard blood pressure (BaP) lowering treatment', 'blood glucose and white blood cell']","['rate of sICH', 'baseline blood glucose and white blood cells (WBC) levels: A (normal glucose\u2009+\u2009WBC), B (hyperglycemia\u2009+\u2009normal WBC), C (normal glucose\u2009+\u2009high WBC), and D (hyperglycemia\u2009+\u2009high WBC', 'blood glucose and WBC', 'Akaike information classification (AIC), Bayesian information classification (BIC), and likelihood ratio test']","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0885454,Group D patients also had a higher rate of sICH (P trend <0.05).,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Zeljka', 'Initials': 'Z', 'LastName': 'Calic', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Department of Neurology, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; The George Institute China at Peking University Health Science Centre, Beijing, PR China; Heart Health Research Center, Beijing, PR China. Electronic address: canderson@georgeinstitute.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106254']
2369,33011502,"Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.","OBJECTIVE


To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.
STUDY DESIGN


A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.
RESULTS


Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).
CONCLUSION


This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.",2020,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"['Intrauterine fundal anaesthesia during endometrial ablation in the office', 'women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women', '96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial', 'one hospital and one independent treatment center in the Netherlands']","['paracervical anaesthesia with fundal anaesthesia', 'fundal infiltration with saline', 'paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline', 'paracervical anaesthesia without fundal anaesthesia', 'intrauterine fundal anaesthesia', 'fundal anaesthesia combined with paracervical anaesthesia']","['Secondary pain scores', 'co-primary endpoints Faces Pain Score and Numeric Rating Score', 'pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications', 'pain scores, satisfaction, and side-effects', 'non-inferiority margin (2.0 points on changes in pain', 'pain during ablation', 'Faces Pain Score', 'pain']","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",96.0,0.583245,Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics.,"[{'ForeName': 'I M A', 'Initials': 'IMA', 'LastName': 'Reinders', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: imke.reinders@maastrichtuniversity.nl.'}, {'ForeName': 'P M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: P.Geomini@mmc.nl.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Leemans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands. Electronic address: Jaklien.Leemans@mmc.nl.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Dieleman', 'Affiliation': 'Science Office, Academy, Máxima MC, Veldhoven, the Netherlands. Electronic address: J.Dieleman@mmc.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: a.timmermans@amsterdamumc.nl.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'de Lange', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; Bergman Clinics Vrouw, Amsterdam, AMC, the Netherlands. Electronic address: m.e.delange@amsterdamumc.nl.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands. Electronic address: M.Bongers@mmc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.09.011']
2370,33011539,Genital Self-Image in Adolescent Girls: The Effectiveness of a Brief Educational Video.,"The study investigated the effectiveness of a very brief video aimed at increasing adolescent girls' knowledge of the variation in normal female genital appearance and improving their attitudes towards their own genitals. The video was developed by the researchers and included information about the anatomical features of cisgender female genitals and their function, as well as emphasizing the diversity in the appearance of these features, particularly the external genitalia or vulvar region. A sample of 343 female adolescents aged 16-18 years were randomly assigned to view the educational video or a control video. The educational video significantly increased the girls' knowledge of female genital anatomy. The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future. The participants who watched the educational video were also more likely to recommend focusing on the diversity in normal female genital appearance when educating other young people on the topic of female genital anatomy. Our results suggest that a very brief educational video could be a useful tool to assist young girls with their genital self-image.",2020,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"['adolescent girls', '343 female adolescents aged 16-18 years', 'Adolescent Girls']","['educational video or a control video', 'Brief Educational Video']","['genital appearance satisfaction', 'Genital Self-Image', ""girls' knowledge of female genital anatomy""]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",343.0,0.014125,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"[{'ForeName': 'Anne Nileshni', 'Initials': 'AN', 'LastName': 'Fernando', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: anfer4@student.monash.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sharp', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: gemma.sharp@monash.edu.'}]",Body image,['10.1016/j.bodyim.2020.08.007']
2371,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND


Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE


To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN


and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES


The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS


During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS


Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
2372,33011649,The Unified Protocol compared with diagnosis-specific protocols for anxiety disorders: 12-month follow-up from a randomized clinical trial.,"OBJECTIVE


To examine whether the Unified Protocol (UP) remains equivalent to single-disorder protocols (SDPs) in the treatment of anxiety disorders at 12-month follow-up.
METHOD


We report results from the 12-month follow-up of a recent randomized equivalence trial [1]. Data are from 179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder and were randomized to either the UP or SDP conditions. Consistent with the parent trial, the primary outcome was principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS). Secondary outcomes included anxiety, depression, and impairment. Missing data were accommodated using multiple imputation (10,000 imputed data sets) under a missing at random assumption. Equivalence between the UP and SDPs was tested using slope difference scores from latent growth models and 95% confidence interval of between-condition effect sizes.
RESULTS


The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up. In addition, there were no significant differences between conditions on secondary outcomes at 12-month follow-up.
CONCLUSIONS


The UP continues to yield outcomes comparable to SDPs at 12-month follow-up, and therefore provides a single intervention that can be used to treat the most commonly occurring psychiatric disorders with durable effects.",2020,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"['179 participants (55.31% female sex, 83.24% White, average age 30.66) who met criteria for a principal anxiety disorder']",['diagnosis-specific protocols'],"['anxiety, depression, and impairment', 'principal diagnosis clinician severity rating (CSR) from the Anxiety Disorder Interview Schedule (ADIS', 'principal diagnosis clinician severity rating']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",,0.0824821,The results indicated that the UP and SDP conditions remained equivalent with regard to principal diagnosis clinician severity rating at 12-month follow-up.,"[{'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Eustis', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America. Electronic address: eeustis@bu.edu.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, The University of Houston, Health and Biomedical Sciences Building, 4849 Calhoun Rd - Room 373, Houston, TX 77204, United States of America.'}, {'ForeName': 'Julianne W', 'Initials': 'JW', 'LastName': 'Tirpak', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Center for Anxiety and Related Disorders, Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. 2(nd) Floor, Boston, MA 02215, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.012']
2373,33011684,Compression sutures combined with intracameral air injection versus thermokeratoplasty for acute corneal hydrops: a prospective-randomised trial.,"AIMS


To compare the efficacy of compression sutures combined with intracameral air injection (CSAI) and thermokeratoplasty (TKP) for the management of acute corneal hydrops in keratoconus.
METHODS


In this multi-centre randomised clinical trial, 20 patients with keratoconus (20 eyes) with acute corneal hydrops were enrolled and randomised to receive either CSAI or TKP and followed-up for a period of 6 months.
RESULTS


There were no significant differences in patient demographics, severity of corneal hydrops and preoperative duration of symptoms between the two groups. In both groups, corneal oedema resolved within 2 weeks. The maximum thickness of the corneal scars following CSAI and TKP was not significantly different. Best spectacle-corrected visual acuity was superior in the CSAI group at 6-month follow-up (CSAI vs TKP, 0.52 (0.37, 0.85) vs 0.96 (0.70, 1.34) LogMAR, p=0.042). CSAI resulted in greater corneal endothelial cell density (CSAI vs TKP, 2677.8±326.7 vs 1955.3±298.1 cells/mm 2 , p<0.001) and flatter corneal curvature (CSAI vs TKP: mean keratometry value, 52.13±4.92 vs 63.51±5.83D, p<0.001; maximum keratometry value, 65.21±7.42 vs 77.13±12.01D, p=0.016) at the 6-month follow-up.
CONCLUSION


Although both CSAI and TKP resulted in resolution of acute corneal hydrops in keratoconus, CSAI was associated with superior clinical outcomes in this study.
CHINESE CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR-IOR-17013764.",2020,"There were no significant differences in patient demographics, severity of corneal hydrops and preoperative duration of symptoms between the two groups.","['acute corneal hydrops', '20 patients with keratoconus (20 eyes) with acute corneal hydrops', 'acute corneal hydrops in keratoconus']","['CSAI', 'Compression sutures combined with intracameral air injection versus thermokeratoplasty', 'CSAI and TKP', 'CSAI or TKP', 'compression sutures combined with intracameral air injection (CSAI) and thermokeratoplasty (TKP']","['maximum thickness of the corneal scars', 'patient demographics, severity of corneal hydrops and preoperative duration of symptoms', 'corneal oedema', 'Best spectacle-corrected visual acuity', 'corneal endothelial cell density', 'flatter corneal curvature']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184946', 'cui_str': 'Injection of air'}, {'cui': 'C0197459', 'cui_str': 'Thermokeratoplasty'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0349702', 'cui_str': 'Corneal scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0205324', 'cui_str': 'Flat'}]",20.0,0.229639,"There were no significant differences in patient demographics, severity of corneal hydrops and preoperative duration of symptoms between the two groups.","[{'ForeName': 'Zelin', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Siteng', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': ""Yinzhou People's Hospital, Ningbo, China.""}, {'ForeName': 'Qinxiang', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Andy D', 'Initials': 'AD', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, The University of Auckland New Zealand National Eye Centre, Auckland, New Zealand.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Jhanji', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, USA.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, The University of Auckland New Zealand National Eye Centre, Auckland, New Zealand.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, China chenweimd@hotmail.com.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316414']
2374,33011690,Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial.,"BACKGROUND/AIMS


The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.
METHODS


This prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication.
RESULTS


Mean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm 2  (n=26) to 2341 cells/mm 2  (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD.
CONCLUSION


This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events.
TRIAL REGISTRATION NUMBER


NCT03193736.",2020,"Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm 2  (n=26) to 2341 cells/mm 2  (n=21) at 24 months, which represents a 5% decrease for matched eyes.","['uncontrolled glaucoma from the STAR-I first-in-human trial', 'patients with medically uncontrolled open-angle glaucoma', '25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone']","['stand-alone, ab interno implantation', 'stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device']","['Complete success', 'success defined as diurnal IOP of ≤21\xa0mmHg and >5\xa0mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication', 'efficacy and safety', 'reduction of intraocular pressure (IOP', 'central ECD', 'qualified success', 'Mean central endothelial cell density (ECD) mildly', 'IOP reduction']","[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2945599', 'cui_str': 'Mild'}]",,0.160183,"Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm 2  (n=26) to 2341 cells/mm 2  (n=21) at 24 months, which represents a 5% decrease for matched eyes.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Denis', 'Affiliation': 'Hôpital de la Croix-Rousse, Lyon, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hirneiß', 'Affiliation': 'Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Georges M', 'Initials': 'GM', 'LastName': 'Durr', 'Affiliation': 'Centre Hospitalier Universitaire de Montréal (CHUM), Montreal, Canada georgesdurr@gmail.com.'}, {'ForeName': 'Kasu Prasad', 'Initials': 'KP', 'LastName': 'Reddy', 'Affiliation': 'Maxivision Super Speciality Eye Hospital, Hyderabad, India.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kamarthy', 'Affiliation': 'Maxivision Super Speciality Eye Hospital, Hyderabad, India.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': 'Panama Eye Center (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Hussain', 'Affiliation': 'iSTAR Medical, Wavre, Belgium.'}, {'ForeName': 'Iqbal K', 'Initials': 'IK', 'LastName': 'Ahmed', 'Affiliation': 'Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316888']
2375,33011715,Training gamblers to re-think their gambling choices: How contextual analytical thinking may be useful in promoting safer gambling.,"Background and aims


Harmful gambling has been associated with the endorsement of fallacious cognitions that promote excessive consumption. These types of beliefs stem from intuitively derived assumptions about gambling that are fostered by fast-thinking and a lack of objective, critical thought. The current paper details an experiment designed to test whether a four-week online intervention to strengthen contextual analytical thinking in gamblers is effective in changing gamblers cognitions and encouraging safer gambling consumption.
Methods


Ninety-four regular gamblers who reported experiencing gambling-related harm were randomly allocated to either an experimental (n = 46) or control condition (n = 48), including 45 males, ranging from 19 to 65 years of age (M = 36.61; SD = 9.76). Following baseline measurement of gambling beliefs and prior week gambling consumption, participants in the experimental condition were required to complete an adaption of the Gamblers Fallacy Questionnaire designed to promote analytical thinking by educating participants on common judgement errors specific to gambling once a week for four weeks. Post-intervention measures of beliefs and gambling consumption were captured in week five.
Results


The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline. The control group also reported a reduction in cognitions relating to predicting and controlling gambling outcomes.
Conclusion


Cognitive interventions that encourage gamblers to challenge gambling beliefs by reflecting on gambling involvement and promoting critical thinking may be an effective tool for reducing the time people invest in gambling activities.",2020,"The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline.","['n = 48), including 45 males, ranging from 19 to 65 years of age (M = 36.61; SD = 9.76', 'Methods\n\n\nNinety-four regular gamblers who reported experiencing gambling-related harm']","['control condition', 'Cognitive interventions']","['erroneous cognitions, greater endorsement of protective cognitions', 'reduction in cognitions relating to predicting and controlling gambling outcomes', 'beliefs and gambling consumption']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",94.0,0.0622413,"The experimental condition reported significantly fewer erroneous cognitions, greater endorsement of protective cognitions, and reduced time spent gambling post-intervention compared to baseline.","[{'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Armstrong', 'Affiliation': '1School of Human, Medical, and Applied Sciences, CQUniversity, 44 Greenhill Road, Wayville, SA, 5034, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rockloff', 'Affiliation': '2School of Human, Medical, and Applied Sciences, CQUniversity, University Drive, Bundaberg, QLD, 4670, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Browne', 'Affiliation': '2School of Human, Medical, and Applied Sciences, CQUniversity, University Drive, Bundaberg, QLD, 4670, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Blaszczynski', 'Affiliation': '3Brain and Mind Centre, School of Psychology, The University of Sydney, M02F Mallett Street Campus, Sydney, NSW, 2006, Australia.'}]",Journal of behavioral addictions,['10.1556/2006.2020.00049']
2376,33011721,"Comparison in the diagnostic yield between ""Pillcam SB3"" capsule endoscopy and ""OMOM Smart Capsule 2"" in small bowel bleeding. A randomized head-to-head study.","Introduction Capsule endoscopy is the first-line tool for diagnosis of small bowel bleeding. There are some studies that have compared different types of capsule endoscopy. OMOM capsule endoscopy is one of the newest in the market, and has not been compared to other types of capsule endoscopy. The objective of this study was to compare the diagnostic yield of the Pillcam SB3 and OMOM capsule endoscopy in small bowel bleeding. Material and methods This is a prospective, comparative, randomized and blinded study. Patients with suspected small bowel bleeding were included. All the patients were given both types of capsules endoscopy in random order. Diagnostic yield and functionality between the two types of capsule endoscopy were analyzed. Results We included 44 patients, 54.5% female with a median of 63.5 years old. Battery time was significantly longer with SB3 (816.5 vs. 700.5 minutes, p<0.001) and the download time was shorter with the OMOM (33 vs. 132 minutes, p<0.001). Both capsule endoscopies presented one failure. The cause of the bleeding was identified in 39 SB3 (88.6%) and in 34 OMOM CE (77.3%) (p=0.256). P2 lesions were observed in 32 SB3 (72.7%) and in 29 OMOM (65.9%) (p=0.784). The agreement between both capsule endoscopies for P2 lesions was moderate (κ=0.628). Conclusions Pillcam SB3 and OMOM devices are safe procedures and have a similar diagnostic yield. Significant differences were observed in the battery life and download time with both capsule endoscopies.",2020,"Battery time was significantly longer with SB3 (816.5 vs. 700.5 minutes, p<0.001) and the download time was shorter with the OMOM (33 vs. 132 minutes, p<0.001).","['44 patients, 54.5% female with a median of 63.5 years old', 'Patients with suspected small bowel bleeding were included', 'small bowel bleeding']","['Pillcam SB3 and OMOM capsule endoscopy', 'Introduction Capsule endoscopy']","['battery life and download time', 'P2 lesions', 'download time', 'Battery time', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]","[{'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",44.0,0.0990373,"Battery time was significantly longer with SB3 (816.5 vs. 700.5 minutes, p<0.001) and the download time was shorter with the OMOM (33 vs. 132 minutes, p<0.001).","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Blanco-Velasco', 'Affiliation': ''}, {'ForeName': 'Raul Antonio', 'Initials': 'RA', 'LastName': 'Zamarripa-Mottú', 'Affiliation': ''}, {'ForeName': 'Omar Michel', 'Initials': 'OM', 'LastName': 'Solórzano-Pineda', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Mascarenhas-Saraiva', 'Affiliation': ''}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Blancas-Valencia', 'Affiliation': ''}, {'ForeName': 'Oscar Victor', 'Initials': 'OV', 'LastName': 'Hernández-Mondragón', 'Affiliation': ''}]","Digestive diseases (Basel, Switzerland)",['10.1159/000511958']
2377,33011734,The Potential Role of Lung-Protective Ventilation in Preventing Postoperative Delirium in Elderly Patients Undergoing Prone Spinal Surgery: A Preliminary Study.,"BACKGROUND Postoperative delirium (POD) is a frequent complication in elderly patients, usually occurring within a few days after surgery. This study investigated the effect of lung-protective ventilation (LPV) on POD in elderly patients undergoing spinal surgery and the mechanism by which LPV suppresses POD. MATERIAL AND METHODS Seventy-one patients aged ≥65 years were randomized to receive LPV or conventional mechanical ventilation (MV), consisting of intermittent positive pressure ventilation following induction of anesthesia. The tidal volume in patients who received MV was 8 ml/kg predicted body weight (PBW), and the ventilation frequency was 12 times/min. The tidal volume in patients who received LPV was 6 ml/kg PBW, the positive end-expiratory pressure was 5 cmH₂O, and the ventilation frequency was 15 times/min, with a lung recruitment maneuver performed every 30 min. Blood samples were collected immediately before anesthesia induction (T₀), 10 min (T₁) and 60 min (T₂) after turning over, immediately after the operation (T₃), and 15 min after extubation (T₄) for blood gas analysis. Simultaneous cerebral oxygen saturation (rSO₂) and cerebral desaturation were recorded. Preoperative and postoperative serum concentrations of interleukin (IL)-6, IL-10 and glial fibrillary acidic protein (GFAP) were measured by ELISA. POD was assessed by nursing delirium screening score. RESULTS Compared with the MV group, pH was lower and PaCO₂ higher in the LPV group at T₂. In addition PaO₂, SaO₂, and PaO₂/FiO₂ were higher at T₁, and T₄, and rSO₂ was higher at T₃, and T₄ in the LPV than in the MV group (P<0.05 each). Postoperative serum GFAP and IL-6 were lower and IL-10 higher in the LPV group. The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05). CONCLUSIONS LPV may reduce POD in elderly patients undergoing spinal surgery by inhibiting inflammation and improving cerebral oxygen metabolism.",2020,The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05).,"['elderly patients', 'Undergoing Prone Spinal Surgery', 'Elderly Patients', 'elderly patients undergoing spinal surgery', 'elderly patients undergoing spinal surgery and the mechanism by which LPV suppresses POD', 'Seventy-one patients aged ≥65 years']","['LPV or conventional mechanical ventilation (MV), consisting of intermittent positive pressure ventilation following induction of anesthesia', 'lung-protective ventilation (LPV', 'LPV', 'Lung-Protective Ventilation']","['cerebral desaturation and POD', 'Preoperative and postoperative serum concentrations of interleukin (IL)-6, IL-10 and glial fibrillary acidic protein (GFAP', 'cerebral oxygen metabolism', 'ventilation frequency', 'Postoperative serum GFAP and IL-6', 'tidal volume', 'POD', 'Simultaneous cerebral oxygen saturation (rSO₂) and cerebral desaturation', 'addition PaO₂, SaO₂, and PaO₂/FiO₂\xa0were higher at T₁, and T₄, and rSO₂']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205250', 'cui_str': 'High'}]",71.0,0.076425,The incidences of cerebral desaturation and POD were significantly lower in the LPV group (P<0.05).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Center of Trauma, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Department of Emergency Center of Trauma, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Qiujun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926526']
2378,33011737,Comparison of pharmacokinetics of omega-3 fatty acid supplements in monoacylglycerol or ethyl ester in humans: a randomized controlled trial.,"BACKGROUND


A diet low in omega-3 fatty acids (n-3 FA) results in low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. n-3 FA supplements on the market are esterified in triglycerides (TG) or ethyl ester (EE); the latter is absorbed less than other esterification forms. The objective of this study was to test and compare the pharmacokinetics of n-3 FA esterified in monoacylglycerides (MAG), a predigested form, with the EE form.
METHODS


This study was a randomized, double-blind, crossover, controlled, clinical trial. Ten men and ten women between 18 and 60 years old were recruited. Participants received a single oral dose of 3 g of n-3 FA esterified in EE or MAG. Eleven blood samples were collected over 24 h post-dose. Plasma total lipids were extracted, methylated, and analyzed using gas chromatography.
RESULTS


After receiving the MAG form, plasma EPA and DHA peaked at a concentration 3 and 2.5 times higher, respectively, than with the EE form. When provided in MAG form, n-3 FA plasma concentration during the absorption phase was on average 3-5 times higher than in EE form. When n-3 FAs were provided esterified in MAG, their concentration 24 h post-dose was higher than in EE. Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG.
CONCLUSIONS


Plasma concentration of DHA and EPA was higher when provided in MAG than EE form.",2020,"Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG.
","['monoacylglycerol or ethyl ester in humans', 'Ten men and ten women between 18 and 60 years old were recruited']","['omega-3 fatty acid supplements', 'n-3 FA esterified', 'omega-3 fatty acids (n-3 FA', 'n-3 FA esterified in EE or MAG', 'n-3 FA supplements']","['n-3 FA plasma concentration', 'Plasma total lipids', 'triglycerides (TG) or ethyl ester (EE', 'plasma EPA and DHA']","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0523744', 'cui_str': 'Lipids measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]",10.0,0.234533,"Males had a lower n-3 FA plasma concentration than females when n-3 FAs were provided in EE but there was no sexe difference when provided in MAG.
","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Chevalier', 'Affiliation': ""Centre de Recherche sur le Vieillissement, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Plourde', 'Affiliation': ""Centre de Recherche sur le Vieillissement, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. Melanie.plourde2@usherbrooke.ca.""}]",European journal of clinical nutrition,['10.1038/s41430-020-00767-4']
2379,33011805,"A Phase 3, Randomised, Open-Label, Non-inferiority Trial Evaluating Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM) Against Human Rabies Immunoglobulin (HRIG).",,2020,,[],"['Against Human Rabies Immunoglobulin (HRIG', 'Anti-Rabies Monoclonal Antibody Cocktail (TwinrabTM']",[],[],"[{'cui': 'C1321098', 'cui_str': 'Human rabies'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}]",[],,0.0405053,,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Maulana Azad Medical College, New Delhi, INDIA.'}, {'ForeName': 'Nandha', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Maulana Azad Medical College, New Delhi, INDIA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1506']
2380,33011864,24-Hour Serial Spirometric Assessment of Once-Daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-Daily Budesonide/Formoterol in Patients with COPD: Analysis of the FULFIL Study.,"INTRODUCTION


Few studies have utilized 24-h serial spirometry to compare the effects of inhaled chronic obstructive pulmonary disease (COPD) therapies on lung function. The FULFIL study previously reported significant lung function improvements with once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR) in patients with symptomatic COPD at risk of exacerbations.
METHODS


This prespecified analysis evaluated 24-h serial spirometry data from a subgroup of 406 patients in FULFIL. BUD/FOR twice-daily dosing was maintained during 24-h spirometry. A post hoc analysis evaluated serial forced expiratory volume in 1 s (FEV 1 ) at day 1 and week 24 by disease severity at screening (FEV 1  < 50% predicted and no moderate or severe exacerbation in prior year, FEV 1  < 50% predicted and ≥ 1 moderate or severe exacerbation in prior year, and FEV 1  ≥ 50% and < 80% predicted and ≥ 2 moderate or ≥ 1 severe exacerbations in prior year).
RESULTS


Odds of achieving a ≥ 100-mL increase from baseline in FEV 1  within the first 6 h post dose on day 1 were significantly greater with FF/UMEC/VI than BUD/FOR [odds ratio 2.79 (95% confidence interval 1.56-4.98); p < 0.001]. FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL; all p < 0.001). Significant between-treatment differences in FEV 1  and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR were seen at all time points at week 24 (FEV 1  range 156-231 mL, all p < 0.001; FVC range 139-309 mL, all p ≤ 0.002). Serial FEV 1  results were consistent irrespective of disease severity at screening.
CONCLUSION


These findings further demonstrate sustained lung function benefits with once-daily FF/UMEC/VI single-inhaler triple therapy in patients with symptomatic COPD at risk of exacerbations across a range of disease severities.",2020,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","['Patients with COPD', '406 patients in FULFIL', 'patients with symptomatic COPD at risk of exacerbations across a range of disease severities', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR', 'Fluticasone Furoate/Umeclidinium/Vilanterol', 'Budesonide/Formoterol']","['serial forced expiratory volume', 'FEV 1  and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR', '24-Hour Serial Spirometric Assessment', 'severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",406.0,0.336625,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1  over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, 1250 S Collegeville Rd, Collegeville, PA, 19426, USA. david.a.lipson@gsk.com.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Birk', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Brealey', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}]",Advances in therapy,['10.1007/s12325-020-01496-7']
2381,33011874,Reliability and validity of the COSMED K5 portable metabolic system during walking.,"PURPOSE


Portable methods for assessing energy expenditure outside the laboratory and clinical environments are becoming more widely used. As such, it is important to understand the accuracy of such devices. Therefore, the purpose was to determine the reliability and validity of the COSMED K5 portable metabolic system.
METHODS


Reliability and validity were assessed in 27 adults (age: 27 ± 5 years; n = 15 women) using a walking protocol. The protocol consisted of a 5-min walk/2-min rest cycle starting at 1.5 mph and increasing in 0.5-mph increments to 4.0 mph. During visit one, participants wore the K5 to assess oxygen consumption ([Formula: see text]O 2 ), carbon dioxide production ([Formula: see text]CO 2 ), and other metabolic variables. Two to seven days later, the protocol was repeated twice with the COSMED K5 and K4b 2  systems in a randomized, counterbalanced order.
RESULTS


Intraclass correlation coefficients (ICC) revealed that the K5 reliably measured [Formula: see text]O 2  (ICC 0.64-0.85) and [Formula: see text]CO 2  across all walking speeds (ICC 0.50-0.80), with stronger reliability at faster walking speeds compared with slower speeds. Moderate-to-strong relationships were observed for measured gases between the K5 and K4b 2 . Specifically, [Formula: see text]O 2  exhibited a moderately high-to-high relationship between devices (r = 0.72-0.82), and a similarly moderately high-to-high relationship was observed for [Formula: see text]CO 2  (r = 0.68-0.82). While there were no differences in [Formula: see text]O 2  measured between devices (p ≥ 0.10), the K5 provided lower [Formula: see text]CO 2  readings than the K4b 2  during the 3.0, 3.5, and 4.0 mph walking speeds (p ≤ 0.02).
CONCLUSIONS


The K5 provided reliable and valid measures of metabolic variables, with greater reliability and validity at faster walking speeds.",2020,"While there were no differences in [Formula: see text]O 2  measured between devices (p ≥ 0.10), the K5 provided lower [Formula: see text]CO 2  readings than the K4b 2  during the 3.0, 3.5, and 4.0 mph walking speeds (p ≤ 0.02).
",['27 adults (age: 27\u2009±\u20095 years; n\u2009=\u200915 women'],"['K5 to assess oxygen consumption ([Formula: see text]O 2 ), carbon dioxide production', 'walking protocol']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],27.0,0.0543346,"While there were no differences in [Formula: see text]O 2  measured between devices (p ≥ 0.10), the K5 provided lower [Formula: see text]CO 2  readings than the K4b 2  during the 3.0, 3.5, and 4.0 mph walking speeds (p ≤ 0.02).
","[{'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'DeBlois', 'Affiliation': 'Department of Exercise Science, Syracuse University, 820 Comstock Ave, Syracuse, NY, 13210, USA.'}, {'ForeName': 'Lindsey E', 'Initials': 'LE', 'LastName': 'White', 'Affiliation': 'Department of Exercise Science, Syracuse University, 820 Comstock Ave, Syracuse, NY, 13210, USA.'}, {'ForeName': 'Tiago V', 'Initials': 'TV', 'LastName': 'Barreira', 'Affiliation': 'Department of Exercise Science, Syracuse University, 820 Comstock Ave, Syracuse, NY, 13210, USA. tvbarrei@syr.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04514-2']
2382,33011964,Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES.,"BACKGROUND


AVERROES, a randomized controlled trial in high-risk patients with atrial fibrillation, unsuitable for vitamin K antagonist therapy, demonstrated efficacy and safety of apixaban compared with aspirin. At the conclusion of the double-blind phase, an open-label extension was initiated to allow study participants to receive apixaban until it became locally available. This study reports outcomes of patients on apixaban during the open-label extension.
METHODS


Rates of stroke or systemic embolism, hemorrhagic stroke, major bleeding, and other outcomes during the open-label extension are reported.
RESULTS


Of the 5,599 participants enrolled in AVERROES, 3,275 (58.5%) received apixaban during the open-label extension. Median (interquartile range) follow-up in the open-label extension was 3.0 (2.5-3.5) years. The rate of stroke or systemic embolism during the open-label extension was 1.0% per year, and the annual rates of hemorrhagic stroke and major bleeding were 0.3 and 1.2%, respectively. After adjustment for imbalances in patient variables, event rates in patients on apixaban during the open-label extension were similar to those of patients receiving apixaban during AVERROES. Additional analyses in all patients who received apixaban, at any time from the start of AVERROES to the end of the open-label extension, were performed. This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
CONCLUSION


During the open-label extension, annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding remained as low as those observed during apixaban treatment in AVERROES. These data support the long-term efficacy and safety of apixaban in patients with atrial fibrillation.",2020,"This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
","['high-risk patients with atrial fibrillation', '5,599 participants enrolled in AVERROES, 3,275 (58.5%) received', 'patients on apixaban during the open-label extension', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation']","['apixaban', 'vitamin K antagonist therapy', 'Apixaban', 'aspirin']","['stroke or systemic embolism, hemorrhagic stroke, major bleeding', 'hemorrhagic stroke', 'annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding', 'rate of stroke or systemic embolism', 'hemorrhagic stroke and major bleeding']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",5599.0,0.0769026,"This cohort ( n  = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.
","[{'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Kahl', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New Jersey, Unites States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beresh', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Balasubramanian', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1717115']
2383,33011968,Comparative study between single versus dual trigger for poor responders in GnRH-antagonist ICSI cycles: A randomized controlled study.,"OBJECTIVE


To investigate whether dual triggering of final oocyte maturation with a combination of gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (hCG) can improve the number of retrieved oocytes and clinical pregnancy rate in poor responders undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol.
METHODS


A randomized controlled trial included poor ovarian responders indicated for ICSI using a GnRH-antagonist protocol. They were divided equally into two groups: group I received 10 000 units of hCG plus 0.2 mg of triptorelin while group II received 10 000 units of hCG only for triggering of ovulation. The primary outcome parameter was the number of oocytes retrieved. Secondary outcomes included metaphase II oocytes number, cancellation rate, number of obtained embryos, chemical and clinical pregnancy rates.
RESULTS


One hundred and sixty women were included in the study, with 80 women in each treatment group. Dual triggering was associated with higher number of retrieved oocytes (5.3 ± 1.9 vs 4.5 ± 2.4, P=0.014), metaphase II oocytes (3.8 ± 1.4 vs 3.1 ± 1.7, P=0.004), total and grade 1 embryos (2.7 ± 1.1 and 2.3 ± 1.0 vs 1.9 ± 1.2 and 1.1 ± 0.2, P=0.001 and 0.021 respectively), and transferred embryos (2.2 ± 0.9 vs 1.6 ± 0.9, P=0.043, and lower cancellation rate (7.5% vs 20%, P=0.037) compared with single triggering. There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
CONCLUSION


Dual triggering is associated with better IVF outcome in poor responders compared with single trigger. Clinical trial registration NCT04008966.",2020,"There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
","['One hundred and sixty women were included in the study, with 80 women in each treatment group', 'poor responders in GnRH-antagonist ICSI cycles', 'poor responders undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol']","['hCG plus 0.2\xa0mg of triptorelin while group II received 10\xa0000 units of hCG', 'GnRH-antagonist protocol', 'gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (hCG']","['higher number of retrieved oocytes', 'metaphase II oocytes', 'pregnancy rates', 'cancellation rate', 'number of oocytes retrieved', 'IVF outcome', 'metaphase II oocytes number, cancellation rate, number of obtained embryos, chemical and clinical pregnancy rates']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",160.0,0.293984,"There were significantly higher chemical (25% vs 11.3%, P=0.039) and clinical (22.5% vs 8.8%, P=0.028) pregnancy rates in women with dual triggering compared with those with single triggering.
","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Ragab', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Shohayeb', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Saber', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Ekladious', 'Affiliation': 'Clinical Pathology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Hussein', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Akmal', 'Initials': 'A', 'LastName': 'El-Mazny', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hany', 'Affiliation': 'Obstetrics and Gynecology Department, Kasr Alainy Hospital Cairo University, Cairo, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13405']
2384,33012017,"Photobiomodulation is effective in oral lichen planus: a randomized, controlled, double-blind study.","OBJECTIVES


To compare the efficacy of Photobiomodulation to that of topical clobetasol 0.05% in patients with symptomatic oral lichen planus (OLP).
SUBJECTS


Thirty-four patients with symptomatic OLP were randomly allocated into two groups: (1) the Control group (n=17), application of topical clobetasol propionate 0.05% three times a day for 30 consecutive days with laser placebo applied twice a week to mask the treatment and (2) the photobiomodulation group (n=17), laser application twice a week, totalling 8 sessions, and gel placebo for 30 consecutive days to mask the treatment. Evaluations were performed once a week during treatment and 30, 60 and 90 days after treatment. The following parameters were evaluated: pain, clinical scores, clinical resolution and recurrence rate.
RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up. Both the Control and photobiomodulation groups presented similar clinical resolution and recurrence rates. Most importantly, no difference was observed between treatments during treatment and follow-up.
CONCLUSIONS


These findings indicate that photobiomodulation twice a week is as effective as corticoid therapy in treating oral lichen planus. Moreover, photobiomodulation is a safe and non-invasive therapy with the remarkable advantage of no adverse effects.",2020,"RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up.","['Thirty-four patients with symptomatic OLP', 'patients with symptomatic oral lichen planus (OLP']","['Control group (n=17), application of topical clobetasol propionate', 'laser placebo', 'Photobiomodulation', 'photobiomodulation group (n=17), laser application twice a week, totalling 8 sessions, and gel placebo']","['clinical resolution and recurrence rates', 'clinical scores', 'pain, clinical scores, clinical resolution and recurrence rate', 'pain']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0055895', 'cui_str': 'Clobetasol propionate'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",34.0,0.0601029,"RESULTS


Photobiomodulation and propionate clobetasol 0.05% were able to significantly decrease pain in oral lichen planus patients and improve clinical scores during treatment and follow-up.","[{'ForeName': 'Elza Padilha', 'Initials': 'EP', 'LastName': 'Ferri', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Karen Roberta Lopes', 'Initials': 'KRL', 'LastName': 'Cunha', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Clery Saad', 'Initials': 'CS', 'LastName': 'Abboud', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'de Barros Gallo', 'Affiliation': 'Department of Stomatology, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'de Sousa Sobral', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Fatima Teixeira da Silva', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Adriana Lino-Dos-Santos', 'Initials': 'AL', 'LastName': 'Franco', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}, {'ForeName': 'Maria Fernanda Setúbal Destro', 'Initials': 'MFSD', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, São Paulo, Brazil.'}]",Oral diseases,['10.1111/odi.13662']
2385,33012083,Oral mucositis after tacrolimus/sirolimus or cyclosporine/methotrexate as graft-versus-host disease prophylaxis.,"OBJECTIVES


To determine whether treatment with tacrolimus plus sirolimus (Tac/Sir) as a prophylaxis for graft-versus-host disease worsens severe oral mucositis and delays healing compared to cyclosporine plus methotrexate (CsA/Mtx) following hematopoietic stem cell transplantation.
SUBJECTS AND METHODS


The study comprised 141 patients: 73 randomized to receive Tac/Sir and 68, to receive CsA/Mtx. The oral mucositis assessment scale and toxicity grading according to WHO were used to assess the severity, peak, and duration of oral mucositis from the day -3 to day 24 post-transplant.
RESULTS


Eighty-seven patients developed oral mucositis in the first 24 days post-transplant. No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed. The peak oral mucositis score occurred on day 10 in both groups. Although oral mucositis scores had returned to baseline in the CsA/Mtx group on day 24 post-transplant, no significant difference compared with the Tac/Sir group was found.
CONCLUSIONS


The introduction of tacrolimus/sirolimus as a graft-versus-host disease prophylaxis in hematopoietic stem cell transplantation increased neither the incidence nor severity of oral mucositis compared with cyclosporine/methotrexate. Furthermore, oral mucositis healing was not prolonged and followed the same time pattern as cyclosporine/methotrexate.",2020,No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed.,['141 patients: 73 randomized to'],"['cyclosporine/methotrexate', 'tacrolimus plus sirolimus (Tac/Sir', 'tacrolimus/sirolimus', 'tacrolimus/sirolimus or cyclosporine/methotrexate', 'receive Tac/Sir and 68, to receive CsA/Mtx', 'cyclosporine plus methotrexate (CsA/Mtx']","['Oral mucositis', 'oral mucositis severity', 'oral mucositis scores', 'peak oral mucositis score', 'oral mucositis healing', 'severity, peak, and duration of oral mucositis', 'oral mucositis', 'oral mucositis assessment scale and toxicity grading']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",141.0,0.0188875,No significant difference in oral mucositis severity between the Tac/Sir and CsA/Mtx groups was observed.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Garming Legert', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Ringdén', 'Affiliation': 'Department of Clinical Sciences, Intervention and Technology, Translational cell therapy research group, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': 'Department of Medical Sciences, Uppsala University and KFUE, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Törlén', 'Affiliation': 'Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mattsson', 'Affiliation': 'Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dahllöf', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}]",Oral diseases,['10.1111/odi.13663']
2386,33012118,Cost-Effectiveness of a Novel Sleep Intervention in Infancy to Prevent Overweight in Childhood.,"OBJECTIVE


The purpose of this study was to determine, from a health funder perspective, whether a sleep intervention, delivered in infancy, either alone or in combination with food, activity, and breastfeeding advice was cost-effective compared with usual care.
METHODS


A cost-effectiveness analysis was conducted alongside the Prevention of Overweight in Infancy (POI) randomized controlled trial for outcomes at 5 years and cost-effectiveness was modeled to age 15 years using the Early Prevention of Obesity in Childhood microsimulation model. Intervention costs for the Sleep (n = 192), Combination (n = 196), and control (n = 209) groups were determined in 2018 Australian dollars. Incremental cost-effectiveness ratios (ICERs) were determined for BMI outcomes at 5 and 15 years, with the primary outcome being quality-adjusted life years (QALYs) modeled over 15 years.
RESULTS


The average costs of the Sleep and Combination interventions were $184 and $601 per child, respectively. The ICER for the Sleep intervention was $18,125 per QALY gained, with a 74% probability of being cost-effective at a willingness-to-pay threshold of $50,000 per QALY. The ICER for the Combination intervention was $94,667 per QALY gained with a 23% probability of being cost-effective.
CONCLUSIONS


The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity. Sleep modification programs offer a very promising approach to obesity prevention in children.",2020,"The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity.","['children', 'age 15 years using the Early Prevention of Obesity in Childhood microsimulation model', 'Infancy to Prevent Overweight in Childhood']",['Novel Sleep Intervention'],"['average costs of the Sleep and Combination interventions', 'Cost-Effectiveness', 'Incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C4521075', 'cui_str': 'Overweight in childhood'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0394979,"The POI Sleep intervention, without additional advice, was a low-cost and cost-effective approach to reducing childhood obesity.","[{'ForeName': 'Eng Joo', 'Initials': 'EJ', 'LastName': 'Tan', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Taylor', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Deakin Health Economics, Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Hayes', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22989']
2387,33012155,Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial.,"PURPOSE


Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients.
MATERIALS AND METHODS


Patients in group I received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/m2 from day 1-5 twice daily and oxaliplatin 50 mg/m2 on day 1 once daily). Patients in group II received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/m2 twice daily. Both groups underwent delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade.
RESULTS


In this preliminary report on complications and pathological response, 66 patients were randomized into study groups. Mean duration of radiotherapy in the two groups was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the short-course and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
CONCLUSION


For patients with rectal cancer located 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.",2020,"Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
","['66 patients', 'patients with rectal cancer', 'Patients in group I received', 'rectal cancer patients', 'middle-aged population of Iran']","['short-course and long-course neoadjuvant chemoradiotherapy treatment', 'capecitabine', 'Short-course versus long-course neoadjuvant chemoradiotherapy', 'XELOX regimen (capecitabine 625 mg/m2 from day 1-5 twice daily and oxaliplatin', 'three-dimensional conformational radiotherapy']","['Mean duration of radiotherapy', 'Pathological complete response', 'Overall, acute grade 3 or higher treatment-related toxicities', 'acute grade 4 or 5 adverse events', 'acute toxicity, postoperative morbidity, complete resection, and pathological response', 'grade ≥3 postoperative complications', 'pathological response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",66.0,0.0854031,"Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333).
","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Aghili', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Babaei', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Farhan', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Haddad', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Salarvand', 'Affiliation': 'Department of Anatomical and Clinical Pathology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Keshvari', 'Affiliation': 'Colorectal Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Fazeli', 'Affiliation': 'Colorectal Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghalehtaki', 'Affiliation': 'Radiation Oncology Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Radiation oncology journal,['10.3857/roj.2020.00115']
2388,33012200,Postnatal Enalapril to Improve Cardiovascular Function Following Preterm Preeclampsia (PICk-UP):: A Randomized Double-Blind Placebo-Controlled Feasibility Trial.,"Hypertensive disease in pregnancy is associated with future cardiovascular disease and, therefore, provides an opportunity to identify women who could benefit from targeted interventions aimed at reducing cardiovascular morbidity. This study focused on the highest-risk group, women with preterm preeclampsia, who have an 8-fold risk of death from future cardiovascular disease. We performed a single-center feasibility randomized controlled trial of 6 months' treatment with enalapril to improve postnatal cardiovascular function. Echocardiography and hemodynamic measurements were performed at baseline (<3 days), 6 weeks, and 6 months postdelivery on 60 women. At randomization, 88% of women had diastolic dysfunction, and 68% had concentric remodeling/hypertrophy. No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain:  P =0.14) between groups at 6 months. However, women treated with enalapril had echocardiographic measurements consistent with improved diastolic function (E/E'[the ratio of early mitral inflow velocity and early mitral annular diastolic velocity]:  P =0.04) and left ventricular remodeling (relative wall thickness:  P =0.01; left ventricular mass index:  P =0.03) at 6 months, compared with placebo. Urinary enalapril was detectable in 85% and 63% of women in the enalapril arm at 6 weeks and 6 months, respectively. All women responded positively to taking enalapril in the future. Our study confirmed acceptability and feasibility of the study protocol with a recruitment to completion rate of 2.2 women per month. Importantly, postnatal enalapril treatment was associated with improved echocardiographic measurements; these early improvements have the potential to reduce long-term cardiovascular disease risk. A definitive, multicenter randomized controlled trial is now required to confirm these findings. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT03466333.",2020,No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain:  P =0.14) between groups at 6 months.,"['highest-risk group, women with preterm preeclampsia, who have an 8-fold risk of death from future cardiovascular disease', 'Following Preterm Preeclampsia (PICk-UP']","['enalapril', 'placebo', 'Placebo', 'Postnatal Enalapril']","['diastolic dysfunction', 'total vascular resistance', 'Echocardiography and hemodynamic measurements', 'Cardiovascular Function', 'systolic function', 'left ventricular remodeling', 'Urinary enalapril', 'echocardiographic measurements', ""diastolic function (E/E'[the ratio of early mitral inflow velocity and early mitral annular diastolic velocity"", 'postnatal cardiovascular function', 'concentric remodeling/hypertrophy']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",60.0,0.615887,No difference was seen in total vascular resistance ( P =0.59) or systolic function (global longitudinal strain:  P =0.14) between groups at 6 months.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ormesher', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, University of Manchester, United Kingdom (L.O., E.C., E.D.J., J.E.M.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higson', 'Affiliation': 'Manchester Heart Centre, Manchester University NHS Foundation Trust, United Kingdom. (S.H., M.L.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Luckie', 'Affiliation': 'Manchester Heart Centre, Manchester University NHS Foundation Trust, United Kingdom. (S.H., M.L.).'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Roberts', 'Affiliation': 'Centre for Biostatistics, University of Manchester, United Kingdom (S.A.R.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Glossop', 'Affiliation': ""St Mary's Hospital, Manchester University NHS Foundation Trust, United Kingdom. (L.O., H.G., E.D.J., J.E.M.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trafford', 'Affiliation': 'Division of Cardiovascular Sciences, University of Manchester, United Kingdom (A.T.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cottrell', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, University of Manchester, United Kingdom (L.O., E.C., E.D.J., J.E.M.).'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Johnstone', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, University of Manchester, United Kingdom (L.O., E.C., E.D.J., J.E.M.).'}, {'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Myers', 'Affiliation': 'From the Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, University of Manchester, United Kingdom (L.O., E.C., E.D.J., J.E.M.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15875']
2389,33012216,Whey protein supplementation does not accelerate recovery from a single bout of eccentric exercise.,"The current double blind, randomized, placebo-controlled trial with two parallel groups aimed to assess the impact of whey protein supplementation on recovery of muscle function and muscle soreness following eccentric exercise. During a 9-day period, forty recreationally active males received twice daily supplementation with either whey protein (PRO; 60 g/day) or an iso-energetic amount of carbohydrate (CON). Muscle function and soreness were assessed before, and 0, 3, 24, 48, and 72 h after performing 100 drop jumps. Recovery of isometric maximal voluntary contraction (MVC) did not significantly differ between groups (timextreatment,  P  = 0.56). In contrast, the recovery of isokinetic MVC at 90°·s -1  was faster in CON as opposed to PRO (timextreatment interaction,  P  = 0.044). Recovery of isokinetic MVC at 180°·s -1  was also faster in CON as opposed to PRO (timextreatment interaction,  P  = 0.011). Recovery of countermovement jump performance did not differ between groups (timextreatment interaction,  P  = 0.52). Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups. In conclusion, whey protein supplementation does not accelerate recovery of muscle function or attenuate muscle soreness and inflammation during 3 days of recovery from a single bout of eccentric exercise.",2020,"Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups.",['forty recreationally active males received'],"['twice daily supplementation with either whey protein (PRO; 60\xa0g/day) or an iso-energetic amount of carbohydrate (CON', 'Whey protein supplementation', 'placebo', 'whey protein supplementation']","['recovery of isokinetic MVC', 'Muscle soreness, CK and CRP', 'Recovery of isometric maximal voluntary contraction (MVC', 'Recovery of isokinetic MVC', 'Recovery of countermovement jump performance', 'Muscle function and soreness', 'recovery of muscle function and muscle soreness']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",,0.472525,"Muscle soreness, CK and CRP showed a transient increase over time ( P  < 0.001), with no differences between groups.","[{'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'Hilkens', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'De Bock', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Kretzers', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Alwine F M', 'Initials': 'AFM', 'LastName': 'Kardinaal', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Esther G', 'Initials': 'EG', 'LastName': 'Floris-Vollenbroek', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Petra A M J', 'Initials': 'PAMJ', 'LastName': 'Scholtens', 'Affiliation': 'NIZO Food Research , Ede, The Netherlands.'}, {'ForeName': 'Astrid M H', 'Initials': 'AMH', 'LastName': 'Horstman', 'Affiliation': 'FrieslandCampina , Amersfoort, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van Dijk', 'Affiliation': 'Institute of Sports and Exercise Studies, HAN University of Applied Sciences , Nijmegen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1820184']
2390,33012243,Hoping to Pass: Randomized Trial of a One-Time Hope Intervention on Standardized Exam Passing Rates in BSN Students.,"BACKGROUND


National standardized nursing exams serve as critical measures of student readiness for practice and carry significant consequences for students and academic institutions. Educational interventions that can enhance a student's performance increase the probability of academic success. Previous studies link hope to grade point average in college students and on standardized exam (SE) scores in nursing students, yet it is not clear if hope can be increased utilizing a one-time intervention in ways that produce lasting benefits for passing SEs.
OBJECTIVE


Aim 1 tested the efficacy of a one-time hope intervention on increasing SE passing rates among BSN nursing students. Aim 2 examined the role of the interventions, selected state-mechanism variables, and trait characteristics in predicting SE passing.
METHOD


This comparative-effectiveness trial utilized a randomized, controlled, multiple-cohort experimental design to compare a one-time 90-minute hope intervention to an attention-matched progressive muscle relaxation intervention on SE passing scores among BSN nursing students.
RESULTS


Levels of hope briefly increased following the hope intervention. Both interventions demonstrated short-term improvement in state-level psychosocial indicators but did not affect SE scores. Among trait and mechanism factors, only academic self-efficacy was linked with passing SEs.
CONCLUSIONS


This study demonstrated that a single-session hope intervention can increase short-term hope. In this sample of 292 BSN students, there was no statistically significant long-term effect on passing SEs; however, this study may lay the groundwork for future interventions investigating booster sessions, or how to modify the intervention for struggling students.",2020,"In this sample of 292 BSN students, there was no statistically significant long-term effect on passing SEs; however, this study may lay the groundwork for future interventions investigating booster sessions, or how to modify the intervention for struggling students.","['college students', 'BSN nursing students', 'BSN Students', 'students and academic institutions', '292 BSN students']",['attention-matched progressive muscle relaxation intervention'],"['passing SEs', 'Standardized Exam Passing Rates', 'SE passing rates', 'state-level psychosocial indicators', 'probability of academic success']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0700132', 'cui_str': 'Academic Achievement'}]",292.0,0.0195823,"In this sample of 292 BSN students, there was no statistically significant long-term effect on passing SEs; however, this study may lay the groundwork for future interventions investigating booster sessions, or how to modify the intervention for struggling students.","[{'ForeName': 'Monika L', 'Initials': 'ML', 'LastName': 'Wedgeworth', 'Affiliation': 'Monika L. Wedgeworth, EdD, RN, CNE, University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Eyer', 'Affiliation': 'Joshua C. Eyer, PhD, University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'March', 'Affiliation': 'Alice L. March, PhD, RN, FNP, CNE, University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Feldman', 'Affiliation': 'David B. Feldman, PhD, Santa Clara University, Santa Clara, CA, USA.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390320962185']
2391,33012244,"Effects of descending or ascending stair exercise on body composition, insulin sensitivity, and inflammatory markers in young Chinese women with obesity: A randomized controlled trial.","We examined the effects of descending (DSE) or ascending (ASE) stair exercise on body composition, insulin sensitivity, and inflammatory markers in young Chinese women with obesity. Thirty-six participants were randomly assigned into three groups DSE, ASE and a control group. The DSE and ASE groups performed three sessions of stair walking per week for 12 weeks with a gradual increase in repetitions. Following the exercise interventions, body composition related variables obtained by Dual-energy X-ray absorptiometry scans significantly decreased. Abdominal fat decreased in the DSE group only. Moreover, Insulin sensitivity improved significantly 3.5-fold in the DSE group compared with ASE group (insulin: -33.2% vs. -9.8%, homoeostasis model assessment for insulin resistance: -35.6% vs. -10.8%). Pro-inflammatory factors showed significant decreases in tumour necrosis factor-α (TNF-α) (-39.9% vs. -23.2%) for both intervention groups. The reduction in TNF-α concentrations in the DSE group was significantly different compared to the other two groups. Interleukin-6 significantly decreased in both exercise protocols. Our results show that 12-weeks induced stair walking improved body composition parameters in Chinese females with obesity. The results also demonstrate the superiority of the DSE protocol for improving insulin sensitivity. These findings may be attributable to the decreases observed in TNF- α levels.",2020,Pro-inflammatory factors showed significant decreases in tumour necrosis factor-α (TNF-α) (-39.9% vs. -23.2%) for both intervention groups.,"['Thirty-six participants', 'young Chinese women with obesity', 'Chinese females with obesity']","['stair walking', 'DSE', 'ASE', 'descending or ascending stair exercise', 'descending (DSE) or ascending (ASE) stair exercise']","['Interleukin-6', 'body composition parameters', 'Abdominal fat', 'tumour necrosis factor-α (TNF-α', 'TNF- α levels', 'body composition, insulin sensitivity, and inflammatory markers', 'Insulin sensitivity', 'TNF-α concentrations', 'insulin sensitivity']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",36.0,0.0295912,Pro-inflammatory factors showed significant decreases in tumour necrosis factor-α (TNF-α) (-39.9% vs. -23.2%) for both intervention groups.,"[{'ForeName': 'Bik Chu', 'Initials': 'BC', 'LastName': 'Chow', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Hong Kong Baptist University , Hong Kong, China.'}, {'ForeName': 'Shuoqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Physical Education College, Hebei Normal University , Shijiazhuang, China.'}, {'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Hong Kong Baptist University , Hong Kong, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Hong Kong Baptist University , Hong Kong, China.'}, {'ForeName': 'Binh', 'Initials': 'B', 'LastName': 'Quach', 'Affiliation': 'Department of Sport and Physical Education, Hong Kong Baptist University , Hong Kong, China.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Department of Sport and Physical Education, Hong Kong Baptist University , Hong Kong, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Physical Education College, Hebei Normal University , Shijiazhuang, China.'}]",Journal of sports sciences,['10.1080/02640414.2020.1829362']
2392,33012264,Racial Disparities in Patient Activation: The Role of Economic Diversity.,"The Patient Activation Measure (PAM) assesses a person's level of knowledge, skills, and confidence to self-manage their day-to-day health. We conducted a mediation analysis to examine potential direct effects of race on significantly lower baseline PAM scores in Black than in White participants (p<0.001) who were a subset of 184 adults who participated in a randomized controlled trial. In the mediation analysis, using natural indirect effects, the continuous outcome was the PAM score. The mediators were income, education, ability to pay bills, and health literacy; race (Black or White) was the ""exposure."" The results indicate that income (p=0.025) and difficulty paying monthly bills (p=0.04) mediated the relationship between race and baseline PAM score, whereas health literacy (p=0.301) and education (p=0.436) did not. Researchers must further investigate the role of economic diversity as an underlying mechanism of patient activation and differences in outcomes.Clinical Trial Registration: Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research: NCT03766841https://clinicaltrials.gov/ct2/show/NCT03766841?term=crotty&draw=2&rank=1.",2020,"The results indicate that income (p=0.025) and difficulty paying monthly bills (p=0.04) mediated the relationship between race and baseline PAM score, whereas health literacy (p=0.301) and education (p=0.436) did not.","['Patient Activation', 'Black than in White participants (p<0.001) who were a subset of 184 adults who participated in a randomized controlled trial']",[],"['income, education, ability to pay bills, and health literacy; race (Black or White', 'PAM score', ""Patient Activation Measure (PAM) assesses a person's level of knowledge, skills, and confidence to self-manage their day-to-day health"", 'health literacy', 'Avoiding Health Disparities']","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004895', 'cui_str': 'Beak'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4075848', 'cui_str': 'Patient Activation Measure score'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.133723,"The results indicate that income (p=0.025) and difficulty paying monthly bills (p=0.04) mediated the relationship between race and baseline PAM score, whereas health literacy (p=0.301) and education (p=0.436) did not.","[{'ForeName': 'Jeana M', 'Initials': 'JM', 'LastName': 'Holt', 'Affiliation': 'University of Wisconsin Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Winn', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cusatis', 'Affiliation': 'Medical College of Wisconsin Department of Medicine, Milwaukee, WI, USA.'}, {'ForeName': 'AkkeNeel', 'Initials': 'A', 'LastName': 'Talsma', 'Affiliation': 'University of Wisconsin Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Bradley H', 'Initials': 'BH', 'LastName': 'Crotty', 'Affiliation': 'Medical College of Wisconsin Department of Medicine, Milwaukee, WI, USA.'}]",Western journal of nursing research,['10.1177/0193945920963130']
2393,33012276,Foot Care Self-Management in Non-Diabetic Older Adults: A Pilot Controlled Trial.,"Self-management can mitigate common foot problems; however, community-dwelling older adults without diabetes rarely receive foot care self-management training. This two-group pilot study examined feasibility and preliminary efficacy of the novel, nurse-led 2 Feet 4 Life intervention. Twenty-nine adults ( M  age 76 years ± 6.6 years) from two senior centers completed the study (90.6% retention rate). Intervention dosage was one hour/week for four consecutive weeks. Study procedures were safe and feasible. Intervention group participants found the intervention acceptable and valuable. Observed between-group effect sizes were the following: knowledge (4.339), self-efficacy (3.652), behaviors (3.403), pain (0.375) and foot health (0.376). Large effect sizes were observed within-groups and within their interaction for knowledge (1.316), behaviors (8.430), pain (9.796), and foot health (3.778). Effect sizes suggest the intervention impacted foot care outcomes between groups and within individuals over seven months' time. Fully powered studies are indicated to test the intervention in diverse samples with more complex foot problems.",2020,"Observed between-group effect sizes were the following: knowledge (4.339), self-efficacy (3.652), behaviors (3.403), pain (0.375) and foot health (0.376).","['Non', 'Twenty-nine adults ( M  age 76 years ± 6.6 years) from two senior centers completed the study (90.6% retention rate', 'Diabetic Older Adults']","['novel, nurse-led 2 Feet 4 Life intervention', 'Self-management']","['knowledge (4.339), self-efficacy (3.652), behaviors (3.403), pain (0.375) and foot health', 'knowledge (1.316), behaviors (8.430), pain (9.796), and foot health']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0260826,"Observed between-group effect sizes were the following: knowledge (4.339), self-efficacy (3.652), behaviors (3.403), pain (0.375) and foot health (0.376).","[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': ""O'Connor"", 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Chelsea B', 'Initials': 'CB', 'LastName': 'Deroche', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Deidre D', 'Initials': 'DD', 'LastName': 'Wipke-Tevis', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}]",Western journal of nursing research,['10.1177/0193945920962712']
2394,33012286,Adipose tissue area as a predictor for the efficacy of apatinib in platinum-resistant ovarian cancer: an exploratory imaging biomarker analysis of the AEROC trial.,"BACKGROUND


Vascular endothelial growth factor (VEGF)-targeted therapy is effective in patients with ovarian cancer. Whether adipose tissue (AT) could predict the efficacy of VEGF receptor (VEGFR) inhibitors in ovarian cancer is unknown. We aimed to evaluate the ability of distinct AT depots to predict the efficacy of apatinib, a VEGFR inhibitor, in recurrent ovarian cancers included in the AEROC trial.
METHODS


The AEROC was a single-arm phase 2 trial of apatinib and oral etoposide in patients with platinum-resistant or platinum-refractory ovarian cancer. Apatinib was administered continuously, and oral etoposide was administered every 21 days for a maximum of six cycles. This was a post hoc study based on the AEROC trial. Areas of visceral AT (VAT), subcutaneous AT (SAT), and intermuscular AT (IMAT) were measured using computed tomography scan at baseline to assess their association with the objective response rate, progression-free survival, and overall survival.
RESULTS


Of the 35 treated patients, 31 patients with at least one post-baseline efficacy assessment by computed tomography scan were included in this study. After adjusting for apatinib exposure, high VAT (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.90, P = 0.037) and SAT (OR, 0.16; 95% CI, 0.03-0.87, P = 0.034) were significantly associated with a higher objective response rate. Further, decreased risks of disease progression and death were associated with high VAT (hazard ratio [HR], 0.39; 95% CI, 0.17-0.92, P = 0.031, and HR, 0.12; 95% CI, 0.04-0.40, P < 0.001, respectively), SAT (HR, 0.35; 95% CI, 0.15-0.83, P = 0.027, and HR, 0.24; 95% CI, 0.08-0.67, P = 0.007, respectively), and IMAT (HR, 0.20; 95% CI, 0.06-0.74, P = 0.016, and HR, 0.13; 95% CI, 0.03-0.62, P = 0.011, respectively).
CONCLUSIONS


High areas of VAT, SAT, and IMAT were significantly associated with better outcomes in patients with platinum-resistant or platinum-refractory ovarian cancer who received VEGFR inhibitors. AT assessments may be valuable as patient-specific imaging biomarkers for predicting response to VEGFR inhibitors.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02867956 .",2020,"After adjusting for apatinib exposure, high VAT (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.90, P = 0.037) and SAT (OR, 0.16; 95% CI, 0.03-0.87, P = 0.034) were significantly associated with a higher objective response rate.","['31 patients with at least one post-baseline efficacy assessment by computed tomography scan', 'recurrent ovarian cancers', 'patients with ovarian cancer', 'platinum-resistant ovarian cancer', 'patients with platinum-resistant or platinum-refractory ovarian cancer', 'patients with platinum-resistant or platinum-refractory ovarian cancer who received']","['apatinib and oral etoposide', 'VEGF receptor (VEGFR) inhibitors', 'VEGFR inhibitors', 'oral etoposide', 'Vascular endothelial growth factor (VEGF)-targeted therapy']","['objective response rate, progression-free survival, and overall survival', 'objective response rate', 'visceral AT (VAT), subcutaneous AT (SAT), and intermuscular AT (IMAT', 'risks of disease progression and death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",31.0,0.465331,"After adjusting for apatinib exposure, high VAT (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.90, P = 0.037) and SAT (OR, 0.16; 95% CI, 0.03-0.87, P = 0.034) were significantly associated with a higher objective response rate.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China.'}, {'ForeName': 'Chuanbo', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Cancer Prevention, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Gynecologic Oncology, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Wenzhuo', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'VIP Region, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China.'}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Gynecologic Oncology, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jundong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China.'}, {'ForeName': 'Qiuxia', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Imaging, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jingxian', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Imaging, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'VIP Region, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China. xialp@sysucc.org.cn.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lan', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, China. lanchy@sysucc.org.cn.'}]",BMC medicine,['10.1186/s12916-020-01733-4']
2395,33012517,Cerebral blood flow alterations associated with high volume caudal block in infants.,"BACKGROUND


High-volume (1.5 ml kg -1 ) caudal block in infants results in major reductions of cerebral blood flow velocity (CBFV) and cerebral oxygenation, caused by rostral CSF movement which increases intracranial pressure. The primary aim of this study was to determine the relationship between injected volume and CBFV changes. We hypothesised that this volume-blood flow relationship would have a similar albeit inverted shape to the well-known intracranial pressure volume-pressure curve.
METHODS


Fifteen subjects, age 0-6 months, mean (range) weight 4.9 (2.1-6.4) kg, were studied. A 1.5 ml kg -1  caudal injection of 0.2% ropivacaine was administered in three phases separated by two pauses. Subjects were randomised into five groups, in whom the pauses were implemented at different pre-set proportions of the total injected volume. Middle cerebral artery Doppler ultrasonography was used for CBFV measurements (V max , peak CBF velocity; V min , lowest CBF velocity; velocity time index). Mean flow velocity, pulsatility index, and resistivity index were calculated, and haemodynamic parameters were recorded.
RESULTS


CBFV parameters decreased in all patients. The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline. There was a nonlinear relationship between the volume of the first phase injection and the CBFV measurement during the first pause. Across all time points, there was a linear relationship between volume administered and CBFV. Systemic haemodynamic parameters remained stable throughout the study.
CONCLUSIONS


Injection pauses appear to attenuate adverse CBFV increases during administration of a high-volume caudal block.",2020,"The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline.","['Fifteen subjects, age 0-6 months, mean (range) weight 4.9 (2.1-6.4) kg, were studied', 'infants']",['ropivacaine'],"['Systemic haemodynamic parameters', 'CBFV measurements (V max , peak CBF velocity; V min , lowest CBF velocity; velocity time index', 'cerebral blood flow velocity (CBFV) and cerebral oxygenation', 'Mean flow velocity, pulsatility index, and resistivity index', 'adverse CBFV', 'CBFV parameters', 'Cerebral blood flow alterations']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}]",,0.0538609,"The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Castillo', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden. Electronic address: paul.castillo@sll.se.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Lundblad', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Forestier', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Eksborg', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Women and Child Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per-Arne', 'Initials': 'PA', 'LastName': 'Lönnqvist', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.055']
2396,33012521,"Deep Brain Stimulation of the Subthalamic, Accumbens, or Caudate Nuclei for Patients With Severe Obsessive-Compulsive Disorder: A Randomized Crossover Controlled Study.",,2020,,['With Severe Obsessive-Compulsive Disorder'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",[],[],,0.0578568,,"[{'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Welter', 'Affiliation': 'Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France; Neurophysiology Department, Clinical Research Center-Biological Resources Center 1404, Centre Hospitalier Universitaire de Rouen, University of Rouen, Rouen, France.'}, {'ForeName': 'Joao Flores', 'Initials': 'JF', 'LastName': 'Alves Dos Santos', 'Affiliation': 'Department of Mental Health and Psychiatry, Global Health Institute, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Anne-Helene', 'Initials': 'AH', 'LastName': 'Clair', 'Affiliation': 'Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Hassimiou Mamadou', 'Initials': 'HM', 'LastName': 'Diallo', 'Affiliation': ""Institut Pierre Louis d'Epidémiologie et de Santé Publique, French Institute of Health and Medical Research, Paris, France.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fernandez-Vidal', 'Affiliation': 'Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France.'}, {'ForeName': 'Hayat', 'Initials': 'H', 'LastName': 'Belaid', 'Affiliation': 'Neurosurgery Department, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Pelissolo', 'Affiliation': ""French Institute of Health and Medical Research U955, Mondor Institute for Biomedical Research, Créteil, France; Neurosurgery Department, Département Médico-Universitaire de psychiatrie et d'addictologie, Hôpitaux Universitaires Henri Mondor - Albert Chenevier, Assistance Publique-Hôpitaux de Paris, Université Paris-Est Créteil, Créteil, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Domenech', 'Affiliation': ""Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France; Neurosurgery Department, Département Médico-Universitaire de psychiatrie et d'addictologie, Hôpitaux Universitaires Henri Mondor - Albert Chenevier, Assistance Publique-Hôpitaux de Paris, Université Paris-Est Créteil, Créteil, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Karachi', 'Affiliation': 'Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France; Neurosurgery Department, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mallet', 'Affiliation': ""Institut du cerveau et de la moelle épinière, French Institute of Health and Medical Research U1127, French National Centre for Scientific Research Joint Research Unit 7225, Sorbonne Université, Paris, France; Neurosurgery Department, Département Médico-Universitaire de psychiatrie et d'addictologie, Hôpitaux Universitaires Henri Mondor - Albert Chenevier, Assistance Publique-Hôpitaux de Paris, Université Paris-Est Créteil, Créteil, France; Department of Mental Health and Psychiatry, Global Health Institute, University of Geneva, Geneva, Switzerland. Electronic address: luc.mallet@inserm.fr.""}]",Biological psychiatry,['10.1016/j.biopsych.2020.07.013']
2397,33012573,Restrictive or liberal transfusion for cardiac surgery: Spanish results of a randomized multicenter international parallel open-label clinical trial.,,2020,,[],['Restrictive or liberal transfusion'],[],[],"[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",[],,0.0775817,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Galan', 'Affiliation': 'Department of Anesthesia, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mateo', 'Affiliation': 'Department of Anesthesia, Consorcio Hospital General de Valencia, Valencia, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Carmona', 'Affiliation': 'Department of Anesthesia, Hospital Universitario y Politécnico La Fe de Valencia, Valencia, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gajate', 'Affiliation': 'Department of Anesthesia, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia and LKSKI of Saint Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Martinez-Zapata', 'Affiliation': 'Iberoamerican Cochrane-Centre-Clinical Epidemiology and Health Service.IIB Sant Pau. CIBERESP, Barcelona, Spain. Electronic address: mmartinezz@santpau.cat.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicina intensiva,['10.1016/j.medin.2020.07.011']
2398,33012577,"Perioperative Treatment in Muscle-invasive Bladder Cancer: Analysis of Secondary Endpoints in a Randomized Trial Comparing Gemcitabine and Cisplatin Versus Dose-dense Methotrexate, Vinblastine, Adriamycin, and Cisplatin.",,2020,,['Muscle-invasive Bladder Cancer'],"['Gemcitabine and Cisplatin Versus Dose-dense Methotrexate, Vinblastine, Adriamycin, and Cisplatin']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}]",[],,0.0879366,,"[{'ForeName': 'Irbaz Bin', 'Initials': 'IB', 'LastName': 'Riaz', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Department of Oncology and Metabolism, Academic Unit of Oncology, University of Sheffield Medical School, Sheffield, UK. Electronic address: syed.hussain@sheffield.ac.uk.'}]",European urology,['10.1016/j.eururo.2020.09.018']
2399,33012589,The efficacy of the WhisperFlow CPAP system versus high flow nasal cannula in patients at risk for postextubation failure: A Randomized controlled trial.,"PURPOSE


Compare the efficacy(reintubation rate) between a high-flow nasal cannula(HFNC) and the WhisperFlow CPAP system in patients at risk for postextubation failure.
MATERIAL AND METHODS


RCT was conducted in patients who had at least one high-risk criterion for postextubation failure. All patients were randomly assigned to CPAP or HFNC for 48 h.
RESULTS


Of 140 patients, sixty-nine were assigned to the CPAP group and 71 to the HFNC group. The reintubation rate was similar between the HFNC and WhisperFlowCPAP [5 cases(7.0%) vs. 6 cases(8.7%); P = 0.76]. The postextubation respiratory failure rate was not significantly different between the HFNC and WhisperFlow CPAP groups [10 cases(14.1%)vs.7cases(10.1%); P = 0.48]. The respiratory rate was lower in the HFNC than CPAP group(P = 0.04). The pain rating scale score was lower in the HFNC group than in the WhisperFlow CPAP group at 24 h (2.8 ± 2.0 vs. 3.7 ± 1.9, P = 0.02) and 48 h (2.8 ± 1.8 vs. 3.8 ± 1.9, P = 0.002).
CONCLUSIONS


We are unable to demonstrate a reduction in postextubation respiratory failure in at risk patients with the use of HFNC compared with the WhisperFlow CPAP system probably because small sample size, but HFNC was better tolerated.",2020,The postextubation respiratory failure rate was not significantly different between the HFNC and WhisperFlow,"['patients who had at least one high-risk criterion for postextubation failure', 'patients at risk for postextubation failure', '140 patients, sixty-nine were assigned to the CPAP group and 71 to the HFNC group']","['high-flow nasal cannula(HFNC', 'HFNC and WhisperFlow', 'WhisperFlow CPAP system', 'CPAP or HFNC', 'WhisperFlow CPAP', 'HFNC', 'WhisperFlow CPAP system versus high flow nasal cannula']","['respiratory rate', 'postextubation respiratory failure', 'reintubation rate', 'postextubation respiratory failure rate', 'pain rating scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",140.0,0.0745105,The postextubation respiratory failure rate was not significantly different between the HFNC and WhisperFlow,"[{'ForeName': 'Pongdhep', 'Initials': 'P', 'LastName': 'Theerawit', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattawat', 'Initials': 'N', 'LastName': 'Natpobsuk', 'Affiliation': 'Department of Medicine, Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Tananchai', 'Initials': 'T', 'LastName': 'Petnak', 'Affiliation': 'Division of Pulmonary and Pulmonary Critical Care Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University Bangkok, Thailand.'}, {'ForeName': 'Yuda', 'Initials': 'Y', 'LastName': 'Sutherasan', 'Affiliation': 'Division of Pulmonary and Pulmonary Critical Care Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University Bangkok, Thailand. Electronic address: suthersasan_yuda@yahoo.com.'}]",Journal of critical care,['10.1016/j.jcrc.2020.09.031']
2400,33012596,Effect of Patient State Index Monitoring on the Recovery Characteristics in Morbidly Obese Patients: Comparison of Inhalation Anesthesia and Total Intravenous Anesthesia.,"PURPOSE


Obese patients have a significantly higher risk of adverse effects associated with general anesthesia. The purpose of this study was to evaluate the effects of Patient State Index (PSI) monitoring on recovery from anesthesia and the incidence of any postoperative complications among patients undergoing bariatric surgery with total intravenous anesthesia (TIVA) and inhalational anesthesia.
DESIGN


This prospective, double-blind, and randomized controlled trial was conducted between February 2017 and August 2017 and included 120 morbidly obese patients (body mass index >40 kg/m 2 ).
METHODS


Patients were randomly divided into four groups; group P-PSI (n = 30): TIVA with PSI monitoring; group P (n = 30): TIVA without PSI monitoring; group D-PSI (n = 30): desflurane with PSI monitoring; and group D (n = 30): desflurane without PSI monitoring. The discharge time from the postanesthesia care unit (PACU), postoperative complications, and hemodynamic parameters were recorded and evaluated.
FINDINGS


No significant differences were found in demographic data, duration of anesthesia, admittance to PACU, discharge from PACU, modified Aldrete scores, and perioperative mean blood pressure and heart rate. Nausea and vomiting scores were significantly lower in group P-PSI, group P, and group D-PSI compared with group D.
CONCLUSIONS


Although TIVA and inhalational anesthesia can be safely used for obese patients, intraoperative PSI monitoring may decrease the discharge time from PACU and reduces incidence of postoperative nausea and vomiting caused by inhalation anesthetics.",2020,"No significant differences were found in demographic data, duration of anesthesia, admittance to PACU, discharge from PACU, modified Aldrete scores, and perioperative mean blood pressure and heart rate.","['obese patients', 'Patients', 'Morbidly Obese Patients', 'Obese patients', 'February 2017 and August 2017 and included 120 morbidly obese patients (body mass index >40\xa0kg/m 2 ', 'patients undergoing bariatric surgery with total intravenous anesthesia (TIVA) and inhalational anesthesia']","['desflurane without PSI monitoring', 'Patient State Index (PSI) monitoring', 'Patient State Index Monitoring', 'desflurane with PSI monitoring', 'TIVA without PSI monitoring; group D-PSI', 'Inhalation Anesthesia and Total Intravenous Anesthesia', 'TIVA and inhalational anesthesia']","['discharge time from the postanesthesia care unit (PACU), postoperative complications, and hemodynamic parameters', 'demographic data, duration of anesthesia, admittance to PACU, discharge from PACU, modified Aldrete scores, and perioperative mean blood pressure and heart rate', 'Nausea and vomiting scores']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0528697,"No significant differences were found in demographic data, duration of anesthesia, admittance to PACU, discharge from PACU, modified Aldrete scores, and perioperative mean blood pressure and heart rate.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Demirel', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey. Electronic address: ismaildemirel23@gmail.com.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Yildiz Altun', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}, {'ForeName': 'Esef', 'Initials': 'E', 'LastName': 'Bolat', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}, {'ForeName': 'Mikail', 'Initials': 'M', 'LastName': 'Kilinc', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Deniz', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Aksu', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}, {'ForeName': 'Azize', 'Initials': 'A', 'LastName': 'Bestas', 'Affiliation': 'Medicine Faculty, Anesthesiology and Reanimation Department, Firat University, Elazig, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.07.005']
2401,33012603,Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial.,"Data on influenza vaccine immunogenicity in children are limited from tropical developing countries. We recently reported significant, moderate effectiveness of a trivalent inactivated influenza vaccine (IIV) in a controlled, cluster-randomized trial in children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906). We report immunogenicity of IIV3 and inactivated polio vaccine (IPV) from that trial. We evaluated hemagglutination inhibition (HAI) and polio antibody titers in response to vaccination of three age groups (6 through 35 months, 3 through 5 years, and 6 through 8 years). As all children were IIV naïve, each received two vaccine doses, although titers were assessed after only the first dose for subjects aged 6 through 8 years. Seroconversion rates (4-fold titer rise or increase from <1:10 to ≥1:40) were 74-87% for A/H1N1, 76-87% for A/H3N2, and 54-79% for B/Yamagata. Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata. IIV responses were lowest in the youngest age group, and they were comparable between ages 3 through 5 years after two doses and 6 through 8 years after one dose. We found that baseline seropositivity (HAI titer ≥ 1:10) was an effect modifier of IIV response. Using a seroprotective titer (HAI titer ≥ 1:160) recommended for IIV evaluation in children, we found that among subjects who were seropositive at baseline, 69% achieved seroprotection for both A/H1N1 and A/H3N2, while among those who were seronegative at baseline, seroprotection was achieved in 11% for A/H1N1 and 22% for A/H3N2. The IPV group had high baseline polio antibody seropositivity and appropriate responses to vaccination. Our data emphasize the importance of a two-dose IIV3 series in vaccine naïve children. IIV and IPV vaccines were immunogenic in Senegalese children.",2020,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","['children are limited from tropical developing countries', 'children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906', 'Senegalese children', 'vaccine naïve children', 'three age groups (6 through 35\xa0months, 3 through 5\xa0years, and 6 through 8\xa0years', 'children in Senegal']","['IIV3 and inactivated polio vaccine (IPV', 'trivalent inactivated influenza vaccine (IIV', 'seasonal inactivated influenza and inactivated polio vaccines']","['Seroprotection rates', 'hemagglutination inhibition (HAI) and polio antibody titers', 'Seroconversion rates', 'IIV responses', 'seroprotection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337846', 'cui_str': 'Senegalese'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",,0.0885076,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","[{'ForeName': 'Mbayame', 'Initials': 'M', 'LastName': 'Niang', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Deming', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA; Institute of Human Virology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ndongo', 'Initials': 'N', 'LastName': 'Dia', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'PATH, Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium; Division Global Health Protection, Centers for Disease Control and Prevention, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.059']
2402,33012605,First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3).,"BACKGROUND


BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan.
METHODS


An investigator-initiated, randomised, single-blind, placebo-controlled, dose-escalation study was conducted at Osaka University Hospital with 26 healthy malaria naïve Japanese male adults. The trial was conducted in two stages: Stage/Group 1, half-dose (n = 7 for BK-SE36/CpG and n = 3 for control) and Stage/Group 2, full-dose (n = 11 for BK-SE36/CpG and n = 5 for control). There were two intramuscular vaccinations 21 days apart for both half-dose (0.5 ml: 50 µg SE36 + 500 µg aluminum + 500 µg K3) and full-dose (1.0 ml: 100 µg SE36 + 1000 µg aluminum + 1000 µg K3). A one-year follow-up was done to monitor changes in autoimmune markers and vaccine-induced antibody response.
RESULTS


BK-SE36/CpG was well tolerated. Vaccination site reactions were similar to those observed with BK-SE36. During the trial and follow-up period, no subject had clinical evidence of autoimmune disease. The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination. Antibody titres remained above baseline values during 12 months of follow-up. The vaccine induced antibody was mostly composed of IgG1 and IgM, and recognised epitopes close to the polyserine region located in the middle of SE36.
CONCLUSIONS


BK-SE36/CpG has an acceptable safety profile. Use of CpG-ODN(K3) greatly enhanced immunogenicity in malaria naïve Japanese adults when compared to BK-SE36 alone. The utility of BK-SE36/CpG is currently under evaluation in a malaria endemic setting in West Africa.
TRIAL REGISTRATION


JMACCT Clinical Trial Registry JMA-IIA00109.",2020,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","['26 healthy malaria naïve Japanese male adults', 'malaria naïve Japanese adults', 'malaria endemic setting in West Africa']","['BK-SE36/CpG', 'CpG-ODN(K3', 'SE36\xa0+\xa0500\xa0µg aluminum\xa0+\xa0500\xa0µg\xa0K3) and full-dose', 'Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3', 'placebo', 'SE36\xa0+\xa01000\xa0µg aluminum\xa0+\xa01000\xa0µg\xa0K3']","['immunogenicity', 'Antibody titres', 'tolerated', 'Vaccination site reactions']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}]","[{'cui': 'C0056912', 'cui_str': ""cytidylyl-3'-5'-guanosine""}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1142480', 'cui_str': 'Vaccination site reaction'}]",,0.109799,"The full-dose group had significantly higher titres than the half-dose group (Student's t-test, p = 0.002) at 21 days post-second vaccination.","[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Ezoe', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Environmental Space Infection Control, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Nirianne Marie Q', 'Initials': 'NMQ', 'LastName': 'Palacpac', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kohhei', 'Initials': 'K', 'LastName': 'Tetsutani', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Orthopaedics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Taira', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan; Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Sumiyuki', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hirata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ogata', 'Affiliation': 'Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Jyotheeswara R', 'Initials': 'JR', 'LastName': 'Edula', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Oishi', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tougan', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Ishii', 'Affiliation': 'Laboratory of Adjuvant Innovation/Mockup Vaccine, Center for Vaccine Adjuvant Research, National Institute of Biomedical Innovation, Health and Nutrition, 7-6-8, Saito-Asagi, Ibaraki City, Osaka 567-0085, Japan; Laboratory of Vaccine Science, Immunology Frontier Research Center (IFReC), Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Myoui', 'Affiliation': 'Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: myoi@hp-mctr.med.osaka-u.ac.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Horii', 'Affiliation': 'Department of Molecular Protozoology, Research Institute for Microbial Diseases, Osaka University, 3-1 Yamadaoka, Suita, Osaka 565-0871, Japan. Electronic address: horii@biken.osaka-u.ac.jp.'}]",Vaccine,['10.1016/j.vaccine.2020.09.056']
2403,33012629,The Role of Nutritional and Dietary Habits in Etiology in Pediatric Vocal Fold Nodule.,"OBJECTIVES


In pediatric pediatric vocal fold nodule (VFN) patients, different causes have been suggested in the development of the vocal cord nodule, including laryngopharyngeal reflux (LPR). It is known that the content of consumed foods, obesity, and other dietary behaviors are among the risk factors for the development of reflux. The aim of this study was to evaluate dietary and food consumption habits in pediatric VFN patients.
METHODS


This prospective-controlled study included 50 children with VFNs (age range 5-14 years) and 50 age-matched children without any voice disorders as a control group. BMI values of each participant were evaluated according to age-percentile range. The voice usage habits and personality structure of all the children were questioned. All patients underwent laryngeal examination and voice analysis. The Turkish Pediatric Voice Handicap Index (t-PVHI) and Child Voice Handicap Index-10 (t-CVHI) were completed by patients or their parents. The examination findings of all patients were evaluated with the reflux finding score (RFS), and their complaints were questioned with the reflux symptom index (RSI). In addition, eating and drinking at night, fast eating and excessive food consumption habits and the frequency of consumption of packaged foods defined as junk food, carbonated beverage were questioned. The data obtained were compared statistically between the two groups.
RESULTS


There was no significant difference between the study and control groups in terms of age, gender distribution, median BMI value, voice usage habits, and personality structure. In the study group, t-PVHI, t-CVHI, jitter, schimmer values, the mean RFS, and RSI scores were significantly higher than those of the control group. The number of children with high consumption of junk food and carbonated drinks was higher in the study group. There was no significant difference between the two groups in terms of dietary habits.
CONCLUSION


Food consumption habits may play a role in childhood voice problems in this population.",2020,"There was no significant difference between the study and control groups in terms of age, gender distribution, median BMI value, voice usage habits, and personality structure.","['pediatric VFN patients', 'pediatric pediatric vocal fold nodule (VFN) patients', '50 children with VFNs (age range 5-14 years) and 50 age-matched children without any voice disorders as a control group', 'Pediatric Vocal Fold Nodule']",[],"['number of children with high consumption of junk food and carbonated drinks', 'Turkish Pediatric Voice Handicap Index (t-PVHI) and Child Voice Handicap Index-10 (t-CVHI', 'reflux finding score (RFS', 'dietary and food consumption habits', 'age, gender distribution, median BMI value, voice usage habits, and personality structure', 'BMI values', 't-PVHI, t-CVHI, jitter, schimmer values, the mean RFS, and RSI scores', 'reflux symptom index (RSI', 'dietary habits']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0396053', 'cui_str': ""Singers' nodes""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0007025', 'cui_str': 'Carbonated drink'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}]",50.0,0.0212321,"There was no significant difference between the study and control groups in terms of age, gender distribution, median BMI value, voice usage habits, and personality structure.","[{'ForeName': 'Müge', 'Initials': 'M', 'LastName': 'Özçelik Korkmaz', 'Affiliation': 'Sakarya University Training and Research Hospital, Adapazari, Sakarya, Turkey. Electronic address: ozcelikmuge@gmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Tüzüner', 'Affiliation': 'Başkent University Medical Faculty Ankara Hospital, Ankara, Turkey.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.09.007']
2404,33012641,Extent and prevalence of post-exercise and nocturnal hypoglycemia following peri-exercise bolus insulin adjustments in individuals with type 1 diabetes.,"AIM


To detail the extent and prevalence of post-exercise and nocturnal hypoglycemia following peri-exercise bolus insulin dose adjustments in individuals with type 1 diabetes (T1D) using multiple daily injections of insulins aspart (IAsp) and degludec (IDeg).
METHODS AND RESULTS


Sixteen individuals with T1D, completed a single-centred, randomised, four-period crossover trial consisting of 23-h inpatient phases. Participants administered either a regular (100%) or reduced (50%) dose (100%; 5.1 ± 2.4, 50%; 2.6 ± 1.2 IU, p < 0.001) of individualised IAsp 1 h before and after 45-min of evening exercise at 60 ± 6% V̇O 2max . An unaltered dose of IDeg was administered in the morning. Metabolic, physiological and hormonal responses during exercise, recovery and nocturnal periods were characterised. The primary outcome was the number of trial day occurrences of hypoglycemia (venous blood glucose ≤ 3.9 mmol L  - 1 ). Inclusion of a 50% IAsp dose reduction strategy prior to evening exercise reduced the occurrence of in-exercise hypoglycemia (p = 0.023). Mimicking this reductive strategy in the post-exercise period decreased risk of nocturnal hypoglycemia (p = 0.045). Combining this strategy to reflect reductions either side of exercise resulted in higher glucose concentrations in the acute post-exercise (p = 0.034), nocturnal (p = 0.001), and overall (p < 0.001) periods. Depth of hypoglycemia (p = 0.302), as well as ketonic and counter-regulatory hormonal profiles were similar.
CONCLUSIONS


These findings demonstrate the glycemic safety of peri-exercise bolus dose reduction strategies in minimising the prevalence of acute and nocturnal hypoglycemia following evening exercise in people with T1D on MDI. Use of newer background insulins with current bolus insulins demonstrates efficacy and advances current recommendations for safe performance of exercise.
CLINICAL TRIALS REGISTER


DRKS00013509.",2020,Mimicking this reductive strategy in the post-exercise period decreased risk of nocturnal hypoglycemia (p = 0.045).,"['individuals with type 1 diabetes (T1D', 'Sixteen individuals with T1D, completed a single-centred', 'people with T1D on MDI', 'individuals with type 1 diabetes']",['insulins aspart (IAsp) and degludec (IDeg'],"['acute and nocturnal hypoglycemia', 'Metabolic, physiological and hormonal responses', 'risk of nocturnal hypoglycemia', 'number of trial day occurrences of hypoglycemia (venous blood glucose', 'Depth of hypoglycemia', 'occurrence of in-exercise hypoglycemia', 'nocturnal hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",16.0,0.266413,Mimicking this reductive strategy in the post-exercise period decreased risk of nocturnal hypoglycemia (p = 0.045).,"[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'McCarthy', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, SA1 8EN, UK. Electronic address: Olivia.McCarthy@swansea.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Deere', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Churm', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Dunseath', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, SA2 8QA, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, SA2 8QA, UK.'}, {'ForeName': 'Max L', 'Initials': 'ML', 'LastName': 'Eckstein', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, 8036, Graz, Austria.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Williams', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, SA2 8QA, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, SA2 8QA, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Pitt', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, SA1 8EN, UK.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Group, Medical School, Swansea University, Swansea, SA2 8QA, UK.'}, {'ForeName': 'Othmar', 'Initials': 'O', 'LastName': 'Moser', 'Affiliation': 'Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, 8036, Graz, Austria.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bracken', 'Affiliation': 'Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, SA1 8EN, UK.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.07.043']
2405,33012643,"Changing understanding, perceptions, pain relief of and preference for generic medicines with patient education: An experimental intervention study.","BACKGROUND


Generic medicines have been associated with less perceived efficacy and more side effects compared to brand name drugs. Educational interventions to improve individuals' negative perceptions of generic medicines show contradictory effects.
OBJECTIVE


This study investigated whether an interventional video that informs about the approval process of releasing medicines has better effects on outcomes related to perceptions and effectiveness of generic medicines in participants with headaches, in comparison with another interventional video that addresses bioequivalence between brand name and generic drugs or a control video.
METHODS


Participants with frequent tension headaches were randomized to one of three groups (one of two interventional videos or the control video). One of the interventional videos explained the process of approval of generic medicines (n = 34), the other one explained the bioequivalence between brand name and generic drugs (n = 35). The control video informed participants about the epidemiology and etiology of headaches (n = 34). After watching the video, participants treated their next two consecutive episodes of headache with a brand name and a generic analgesic in randomized order.
MAIN OUTCOME MEASURES


Self-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects.
RESULTS


Linear mixed models showed that both interventional videos improved participants' understanding of generic medicines. The generic drug approval process video enhanced the perceived effectiveness, safety and quality of generic drugs. The bioequivalence video positively influenced the preference for generic drugs. The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.
CONCLUSIONS


Information about both, approving a switch from brand name medicines to generic counterparts and bioequivalence, can be important and should be addressed in future educational interventions.",2020,"The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.
","['participants who watched either the generic drug approval process or the bioequivalence video', 'participants with headaches', 'generic medicines with patient education', 'Participants with frequent tension headaches']",['Educational interventions'],"['relieving pain', ""participants' understanding of generic medicines"", 'Self-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects']","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0289794,"The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'Department of Psychological Medicine, Otago Medical School - Dunedin Campus, University of Otago, 464 Cumberland St, Dunedin, 9016, New Zealand. Electronic address: maria.kleinstaeuber@otago.ac.nz.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Colgan', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1142, New Zealand. Electronic address: Sarah.Colgan@middlemore.co.nz.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1142, New Zealand. Electronic address: kj.petrie@auckland.ac.nz.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.09.014']
2406,33012654,"Long-term efficacy and safety of migalastat treatment in Fabry disease: 30-month results from the open-label extension of the randomized, phase 3 ATTRACT study.","Results from the 18-month randomized treatment period of the phase 3 ATTRACT study demonstrated the efficacy and safety of oral migalastat compared with enzyme replacement therapy (ERT) in patients with Fabry disease who previously received ERT. Here, we report data from the subsequent 12-month, migalastat-only, open-label extension (OLE) period. ATTRACT (Study AT1001-012; NCT01218659) was a randomized, open-label, active-controlled study in patients aged 16-74 years with Fabry disease, an amenable GLA variant, and an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m 2 . During the OLE, patients who received migalastat 150 mg every other day (QOD) during the randomized period continued receiving migalastat (Group 1 [MM]); patients who received ERT every other week discontinued ERT and started migalastat treatment (Group 2 [EM]). Outcome measures included eGFR, left ventricular mass index (LVMi), composite clinical outcome (renal, cardiac or cerebrovascular events), and safety. Forty-six patients who completed the randomized treatment period continued into the OLE (Group 1 [MM], n = 31; Group 2 [EM], n = 15). eGFR remained stable in both treatment groups. LVMi decreased from baseline at month 30 in Group 1 (MM) in patients with left ventricular hypertrophy at baseline. Only 10% of patients experienced a new composite clinical event with migalastat treatment during the OLE. No new safety concerns were reported. In conclusion, in patients with Fabry disease and amenable GLA variants, migalastat 150 mg QOD was well tolerated and demonstrated durable, long-term stability of renal function and reduction in LVMi.",2020,No new safety concerns were reported.,"['Fabry disease', 'patients aged 16-74\xa0years with Fabry disease, an amenable GLA variant, and an estimated glomerular filtration rate (eGFR) ≥30\xa0mL', 'patients with Fabry disease who previously received ERT', 'Forty-six patients']","['enzyme replacement therapy (ERT', 'ERT every other week discontinued ERT and started migalastat treatment', 'migalastat', 'oral migalastat', 'migalastat treatment', 'OLE']","['eGFR, left ventricular mass index (LVMi), composite clinical outcome (renal, cardiac or cerebrovascular events), and safety', 'efficacy and safety', 'eGFR', 'tolerated and demonstrated durable, long-term stability of renal function and reduction in LVMi', 'LVMi']","[{'cui': 'C0002986', 'cui_str': ""Fabry's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2698220', 'cui_str': 'migalastat'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0301809,No new safety concerns were reported.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Medical Endocrinology and Metabolism, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: ufeldt@rh.dk.'}, {'ForeName': 'Derralynn', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Department of Haematology, Royal Free London NHS Foundation Trust and University College London, London, UK.'}, {'ForeName': 'Gere', 'Initials': 'G', 'LastName': 'Sunder-Plassmann', 'Affiliation': 'Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Shankar', 'Affiliation': 'Department of Pediatrics, University of California-Davis, Davis, CA, USA.'}, {'ForeName': 'Khan', 'Initials': 'K', 'LastName': 'Nedd', 'Affiliation': 'Infusion Associates, Grand Rapids, MI, USA.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Cardiomyopathy Unit, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Damara', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': ""Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Toya', 'Initials': 'T', 'LastName': 'Ohashi', 'Affiliation': 'Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hamazaki', 'Affiliation': 'Department of Pediatrics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Skuban', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Barth', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Nicholls', 'Affiliation': 'Department of Nephrology, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.07.007']
2407,33012658,How long does the fertility-enhancing effect of hysterosalpingography with oil-based contrast last?,"RESEARCH QUESTION


Does the fertility-enhancing effect of tubal flushing during hysterosalpingography (HSG) with oil-based contrast change over time?
DESIGN


This was a secondary analysis of the H2Oil (long-term follow-up) study, a multicentre randomized controlled trial evaluating the effectiveness of oil-based and water-based contrast during HSG. The main outcome was ongoing pregnancy. Cox proportional hazards models for time to ongoing pregnancy were fitted over 3 years of follow-up.
RESULTS


Data on 1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG. Ongoing pregnancy rates after 3 years were 77% and 71%, respectively. Median follow-up was 9-10 months (5th-95th percentile: <1 to 36). The hazard ratio for ongoing pregnancy for oil versus water over 3 years of follow-up was 1.26 (95% confidence interval [CI] 1.10-1.45). The scaled Schoenfeld residual plots showed a decrease in hazard ratio that was linear with log-transformed time. After including an interaction with log-transformed time, the hazard ratio immediately after HSG was 1.71 (95% CI 1.27-2.31) and reduced to no effect (hazard ratio of 1) at approximately 2 years. There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
CONCLUSIONS


The hazard ratio for ongoing pregnancy of oil-based versus water-based contrast was 1.71 immediately after HSG, gradually decreasing and plateauing towards a hazard ratio of 1 (indicating no effect) after approximately 2 years. This supports the hypothesis that oil-based contrast might dislodge debris or mucus plugs from the Fallopian tubes, but this has yet to be definitively proved.",2020,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
",['1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG'],['oil-based and water-based contrast during HSG'],"['hazard ratio for ongoing pregnancy', 'Ongoing pregnancy rates', 'hazard ratio']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",1107.0,0.148688,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: n.vanwelie@amsterdamumc.nl.'}, {'ForeName': 'Kimmy', 'Initials': 'K', 'LastName': 'Rosielle', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'van Eekelen', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.038']
2408,33012704,Implementation of the Home-Based mHealth App Intervention Program with Human Mediation for Swallowing Tongue Pressure Strengthening Exercises in Older Adults: Experimental Pilot Study.,"BACKGROUND


Tongue pressure is one of the effective indices of swallowing function, which decreases with aging and disease progression. Previous research has shown beneficial effects of swallowing exercises combined with myofunctional tongue strengthening therapy on tongue function. Tongue exercises utilizing mobile Health (mHealth) technologies would have potential for advancing healthcare in the digital age to be more efficient for people with limited resources, especially older adults.
OBJECTIVE


The purpose of this study was to explore the immediate and long-term maintenance effects of an 8-week home-based mHealth app intervention program with biweekly human mediation aimed at improving the swallowing tongue pressure in older adults.
METHODS


We developed a mobile health (mHealth) app for intervention which was utilized for 8 weeks (3 times/day, 5 days/week, a total of 120 sessions) by 11 community-dwelling older adults (10 women; mean age: 75.7 years) who complained of swallowing difficulties. The app included a SMIP (Swallowing Monitoring & Intervention Protocol) with three therapy maneuvers: effortful prolonged swallowing (EPS), effortful pitch glide (EPG), and effortful tongue rotation (ETR). The 8-week intervention was mediated by biweekly face-to-face meetings to monitor each participant's progress and ability to implement the training sessions according to the given protocol. Pre-intervention and post-intervention isometric and swallowing tongue pressures were measured using the Iowa Oral Performance Instrument (IOPI). We also investigated the maintenance effects of the intervention on swallowing tongue pressure at 12-week post-intervention.
RESULTS


Eight out of 11 participants adhered to the home-based 8-week app therapy program with optimal intervention dosage. At the main trial endpoint (i.e., 8-week) of the intervention program, the participants demonstrated a significant increase in swallowing tongue pressure (median = 17.5 kPa at pre-intervention and 26.5 kPa at post-intervention; P < .05). However, long-term maintenance effects of the training program on swallowing tongue pressure at 12-week post-intervention were not observed.
CONCLUSIONS


Swallowing tongue pressure is known to be closely related with dysphagia symptoms. This is the first study to demonstrate the effectiveness of the combined method of EPS, EPG, and ETR mobile app training, accompanied by biweekly human mediation, on swallowing tongue pressure in older adults. The mHealth app is a promising platform which can be used to deliver effective and convenient therapeutic service to vulnerable older adults. To investigate the therapeutic efficacy with a larger sample size as well as the long-term effects of the intervention program, further studies are warranted.
CLINICALTRIAL



INTERNATIONAL REGISTERED REPORT


RR2-10.2196/19585.",2020,"Tongue exercises utilizing mobile Health (mHealth) technologies would have potential for advancing healthcare in the digital age to be more efficient for people with limited resources, especially older adults.
","['older adults', 'vulnerable older adults', '11 participants adhered to the home-based 8-week app therapy program with optimal intervention dosage', 'Older Adults', '11 community-dwelling older adults (10 women; mean age: 75.7 years) who complained of swallowing difficulties']","['SMIP (Swallowing Monitoring & Intervention Protocol) with three therapy maneuvers: effortful prolonged swallowing (EPS), effortful pitch glide (EPG), and effortful tongue rotation (ETR', 'Tongue exercises utilizing mobile Health (mHealth) technologies', 'swallowing exercises combined with myofunctional tongue strengthening therapy', 'Home-Based mHealth App Intervention Program with Human Mediation for Swallowing Tongue Pressure Strengthening Exercises']",['swallowing tongue pressure'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0589305', 'cui_str': 'Tongue exercises'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0589276', 'cui_str': 'Swallowing exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0858978', 'cui_str': 'Tongue swallowing'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0858978', 'cui_str': 'Tongue swallowing'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",11.0,0.0175538,"Tongue exercises utilizing mobile Health (mHealth) technologies would have potential for advancing healthcare in the digital age to be more efficient for people with limited resources, especially older adults.
","[{'ForeName': 'HyangHee', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Graduate Program in Speech-Language Pathology, Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, 11-12 Yondaedongmun-gil, Seodaemun-gu, Seoul, KR.'}, {'ForeName': 'Nam-Bin', 'Initials': 'NB', 'LastName': 'Cho', 'Affiliation': 'Graduate Program in Speech-Language Pathology, Yonsei University, Seoul, KR.'}, {'ForeName': 'Jinwon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang, KR.'}, {'ForeName': 'Kyung Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Graduate Program in Speech-Language Pathology, Yonsei University, Seoul, KR.'}, {'ForeName': 'Minji', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Graduate Program in Speech-Language Pathology, Yonsei University, Seoul, KR.'}, {'ForeName': 'Younggeun', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang, KR.'}, {'ForeName': 'Minjae', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang, KR.'}, {'ForeName': 'Heecheon', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang, KR.'}, {'ForeName': 'Seok-In', 'Initials': 'SI', 'LastName': 'Nam', 'Affiliation': 'Graduate School of Social Welfare, Yonsei University, Seoul, KR.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Graduate Program in Speech-Language Pathology, Yonsei University, Seoul, KR.'}]",JMIR mHealth and uHealth,['10.2196/22080']
2409,33012729,Continuous hemoperfusion relieves pulmonary fibrosis in patients with acute mild and moderate paraquat poisoning.,"Acute paraquat poisoning (APP) is a serious public health problem with a high mortality rate and there is no specific antidote for APP in clinical. Early haemoperfusion (HP) treatment is effective in APP rescue. In this study, we compared the influence of routine HP and continuous HP on the survival rate and the treatment of pulmonary fibrosis in mild and moderate APP patients. Eighty-two cases of mild and moderate APP patients who were admitted to our hospital from January of 2017 to December of 2018 were selected. All patients were randomly divided into a routine haemoperfusion (HP) group (n = 40) and a continuous haemoperfusion (CHP) group (n = 42). Compared with the HP group, the 28-day survival rate of mild and moderate APP patients was elevated in the CHP group. Blood N-terminal procollagen Ш propeptide (PIIINP) levels in APP patients were positively related with paraquat (PQ) concentration (r = 0.309, P = 0.000). There were statistically significant differences in the levels of PIIINP, Collage TypeIV (CIV), transforming growth factor-beta 1 (TGF-β1), malondialdehyde (MDA), superoxide dismutase (SOD) activity and sequential organ failure assessment (SOFA) score between the two groups both on the third and seventh days after treatment, and the treatment effect of the CHP group on pulmonary fibrosis in APP patients was better than that of the HP group. In conclusion, CHP treatment had a significant therapeutic effect on mild and moderate APP patients, which could effectively improve the survival rate and relieve pulmonary fibrosis.",2020,"There were statistically significant differences in the levels of PIIINP, Collage TypeIV (CIV), transforming growth factor-beta 1 (TGF-β1), malondialdehyde (MDA), superoxide dismutase (SOD) activity and sequential organ failure assessment (SOFA) score between the two groups both on the third and seventh days after treatment, and the treatment effect of the CHP group on pulmonary fibrosis in APP patients was better than that of the HP group.","['pulmonary fibrosis in mild and moderate APP patients', 'patients with acute mild and moderate paraquat poisoning', 'Eighty-two cases of mild and moderate APP patients who were admitted to our hospital from January of 2017 to December of 2018 were selected', 'Acute paraquat poisoning (APP']","['Continuous hemoperfusion', 'CHP', 'routine haemoperfusion (HP', 'continuous haemoperfusion (CHP', 'routine HP and continuous HP', 'HP', 'Early haemoperfusion (HP', 'Blood N-terminal procollagen Ш propeptide']","['pulmonary fibrosis', '28-day survival rate', 'levels of PIIINP, Collage TypeIV (CIV), transforming growth factor-beta 1 (TGF-β1), malondialdehyde (MDA), superoxide dismutase (SOD) activity and sequential organ failure assessment (SOFA) score', 'survival rate and relieve pulmonary fibrosis', 'paraquat (PQ) concentration', 'PIIINP) levels', 'survival rate']","[{'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030493', 'cui_str': 'Paraquat'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}]","[{'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0080222', 'cui_str': 'TGFB1 protein, human'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0030493', 'cui_str': 'Paraquat'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0274564,"There were statistically significant differences in the levels of PIIINP, Collage TypeIV (CIV), transforming growth factor-beta 1 (TGF-β1), malondialdehyde (MDA), superoxide dismutase (SOD) activity and sequential organ failure assessment (SOFA) score between the two groups both on the third and seventh days after treatment, and the treatment effect of the CHP group on pulmonary fibrosis in APP patients was better than that of the HP group.","[{'ForeName': 'Qingmian', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Weizhan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Hongna', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Baoyue', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Emergency Department of Harrison International Peace Hospital Affiliated to Hebei Medical University, China.'}]",The Journal of toxicological sciences,['10.2131/jts.45.611']
2410,33012782,A Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients with EGFR mutation-positive locally advanced/metastatic non-small-cell lung cancer.,"BACKGROUND


EGFR tyrosine kinase inhibitors (TKIs) induce cytolysis and release of tumour proteins, which can stimulate antigen-specific T cells. The safety and efficacy of durvalumab and gefitinib in combination for TKI-naive patients with advanced EGFRm NSCLC was evaluated.
METHODS


This Phase 1 open-label, multicentre trial (NCT02088112) was conducted in 56 patients with NSCLC. Dose expansion permitted TKI-naive patients, primarily with activating L858R or Ex19del EGFRm. Arms 1 + 1a received concurrent therapy; Arm 2 received 4 weeks of gefitinib induction followed by concurrent therapy.
RESULTS


From dose escalation, the recommended dose of durvalumab was 10 mg/kg Q2W with 250 mg QD gefitinib. Pharmacokinetics were as expected, consistent with inhibition of soluble PD-L1 and no treatment-emergent immunogenicity. In dose expansion, 35% of patients had elevated liver enzymes leading to drug discontinuation. In Arms 1 + 1a, objective response rate was 63.3% (95% CI: 43.9-80.1), median progression-free survival (PFS) was 10.1 months (95% CI: 5.5-15.2) and median response duration was 9.2 months (95% CI: 3.7-14.0).
CONCLUSIONS


Durvalumab and gefitinib in combination had higher toxicity than either agent alone. No significant increase in PFS was detected compared with historical controls. Therefore, concurrent PD-L1 inhibitors with gefitinib should be generally avoided in TKI-naive patients with EGFRm NSCLC.",2020,"In Arms 1 + 1a, objective response rate was 63.3% (95% CI: 43.9-80.1), median progression-free survival (PFS) was 10.1 months (95% CI: 5.5-15.2) and median response duration was 9.2 months (95% CI: 3.7-14.0).
","['TKI-naive patients with advanced EGFRm NSCLC was evaluated', '56 patients with NSCLC', 'EGFR TKI-naive patients with EGFR mutation-positive locally advanced/metastatic non-small-cell lung cancer', 'TKI-naive patients with EGFRm NSCLC']","['durvalumab', 'gefitinib combined with durvalumab', 'durvalumab and gefitinib', 'gefitinib induction followed by concurrent therapy']","['median progression-free survival (PFS', 'median response duration', 'safety and efficacy', 'toxicity', 'PFS', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",56.0,0.101986,"In Arms 1 + 1a, objective response rate was 63.3% (95% CI: 43.9-80.1), median progression-free survival (PFS) was 10.1 months (95% CI: 5.5-15.2) and median response duration was 9.2 months (95% CI: 3.7-14.0).
","[{'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Creelan', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB-1, Tampa, FL, 33612, USA. Ben.Creelan@moffitt.org.'}, {'ForeName': 'Tammie C', 'Initials': 'TC', 'LastName': 'Yeh', 'Affiliation': 'Translational Medicine, Oncology R&D, AstraZeneca, 35 Gatehouse Drive, Waltham, MA, 02451, USA.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 160 Minami-Umemoto-cho, Matsuyama City, 791-0280, Japan.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington/Seattle Cancer Care Alliance, Seattle, WA, 98109, USA.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, 3-1-1 Asahi Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Oncology, AstraZeneca, Academy House, 132-136 Hills Road, Cambridge, CB2 8PA, UK.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Clinical Pharmacology and Safety Assessment, AstraZeneca, One Medimmune Way, 101 ORD, 2001D, Gaithersburg, MD, 20878, USA.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Clinical Pharmacology and Safety Assessment, AstraZeneca, One Medimmune Way, 101 ORD, 2001D, Gaithersburg, MD, 20878, USA.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Angell', 'Affiliation': 'Translational Medicine, Oncology R&D, AstraZeneca, Darwin Building, Unit 310, Cambridge Science Park, Milton Road, Cambridge, CB4 0WG, UK.'}, {'ForeName': 'Martine P', 'Initials': 'MP', 'LastName': 'Roudier', 'Affiliation': 'Translational Medicine, Oncology R&D, AstraZeneca, Darwin Building, Unit 310, Cambridge Science Park, Milton Road, Cambridge, CB4 0WG, UK.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Marotti', 'Affiliation': 'Oncology, AstraZeneca, Academy House, 132-136 Hills Road, Cambridge, CB2 8PA, UK.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': 'Departments of Thoracic/Head and Neck Medical Oncology and Molecular and Cellular Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA.'}]",British journal of cancer,['10.1038/s41416-020-01099-7']
2411,33012810,A pilot study of the effects of suboccipital fascial release on cortisol levels in workers in the clothing industry - randomized clinical trial.,"Introduction


Repetitive and time sensitive demands of clothing workers has been associated with higher salivary cortisol levels that may reflect the stress experienced by the worker.
Objective


This trial evaluates if suboccipital fascial release (SFR) is associated with reduced salivary cortisol levels.
Methods


Randomized controlled trial with 40 workers, divided into: untreated group (UG, n = 15) and treated group (TG, n = 25). Both were removed from the work environment. The TG received the above technique and the UG remained lying at rest, both for five minutes. Salivary cortisol levels were measured by a commercial enzyme-linked immunosorbent assay (ELISA) kit. Statistical analysis of data distribution, intragroup and intergroups, were performed with α adjusted to 0.05.
Results


Pre / post intragroup analyses showed significant differences in cortisol levels in both groups, as well as intergroup analyses with lower values in favor of TG (p = 0.014).
Conclusion


The reduction in salivary cortisol levels in TG suggests that SFR may be more effective than rest in reducing stress. Future studies with increased experimental rigor are necessary to confirm this conclusion.
Clinical trial registration number


REBEC - RBR - 56yk9m.",2020,"Results


Pre / post intragroup analyses showed significant differences in cortisol levels in both groups, as well as intergroup analyses with lower values in favor of TG (p = 0.014).
",['40 workers'],"['suboccipital fascial release', 'suboccipital fascial release (SFR']","['salivary cortisol levels', 'cortisol levels', 'Salivary cortisol levels']","[{'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",40.0,0.122107,"Results


Pre / post intragroup analyses showed significant differences in cortisol levels in both groups, as well as intergroup analyses with lower values in favor of TG (p = 0.014).
","[{'ForeName': 'Bruna Luísa', 'Initials': 'BL', 'LastName': 'Silva', 'Affiliation': 'Centro Universitário de Formiga - UNIFOR-MG, Formiga, Minas Gerais, Brazil.'}, {'ForeName': 'Lara Alves', 'Initials': 'LA', 'LastName': 'de Oliveira', 'Affiliation': 'Centro Universitário de Formiga - UNIFOR-MG, Formiga, Minas Gerais, Brazil.'}, {'ForeName': 'Camila Medeiros', 'Initials': 'CM', 'LastName': 'Costa', 'Affiliation': 'Centro Universitário de Formiga - UNIFOR-MG, Formiga, Minas Gerais, Brazil.'}, {'ForeName': 'Cristiano Queiroz', 'Initials': 'CQ', 'LastName': 'Guimarães', 'Affiliation': 'Faculdade Ciências Médicas de Minas Gerais - CMMG, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Leonardo Sette', 'Initials': 'LS', 'LastName': 'Vieira', 'Affiliation': 'Academia Brasileira de Fáscias (ABFascias), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Andrei Pereira', 'Initials': 'AP', 'LastName': 'Pernambuco', 'Affiliation': 'Centro Universitário de Formiga - UNIFOR-MG, Formiga, Minas Gerais, Brazil.'}]",The Journal of the Canadian Chiropractic Association,[]
2412,33012870,Patient Response Trajectories in Major Depressive Disorder.,"Objective


To investigate whether the efficacy of antidepressants can be understood in terms of patient response-trajectory classes.
Experimental Design


Patient-level data were analysed from 1357 adults with MDD randomised to either escitalopram 20 mg/day ( n  = 676) or placebo ( n  = 681) in five 8-week randomised placebo-controlled trials. Growth mixture models (GMMs) were used to identify the response trajectories; longitudinal latent class analysis (LLCA) was used to corroborate the findings.
Principal Observations


Three classes of response were identified for escitalopram and placebo based on the trajectory of the patients' Montgomery-Åsberg Depression Rating Scale (MADRS) total scores during treatment. All three classes had similar mean baseline MADRS scores, but the change from baseline after 8 weeks differed: -4.2 MADRS points for non-responders, -18.4 MADRS points for slow responders, and -26.7 points for fast responders. The proportions of non-responders, slow responders and fast responders were 53%, 38% and 9%, respectively, with placebo and 27%, 58% and 14%, respectively, with escitalopram. Receiver operating curve analysis showed that a cut-off of ≥43% improvement from baseline to week 2 predicted fast responders, and a cut-off of ≥28% improvement from baseline to week 4 predicted responders (fast or slow). There were no clinically useful differences at baseline that predicted the trajectory class to which a patient would belong.
Conclusions


The presence of fast-, slow- and non-responder classes has a clear clinical relevance for guiding treatment decisions; individual patients can be classified by the change in their MADRS score from baseline at 2 or 4 weeks.",2020,"The proportions of non-responders, slow responders and fast responders were 53%, 38% and 9%, respectively, with placebo and 27%, 58% and 14%, respectively, with escitalopram.",['1357 adults with MDD randomised to either'],"['placebo', 'escitalopram 20 mg/day ( n  = 676) or placebo', 'Growth mixture models (GMMs']","['mean baseline MADRS scores', 'Montgomery-Åsberg Depression Rating Scale (MADRS) total scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1171041', 'cui_str': 'Escitalopram 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1357.0,0.220514,"The proportions of non-responders, slow responders and fast responders were 53%, 38% and 9%, respectively, with placebo and 27%, 58% and 14%, respectively, with escitalopram.","[{'ForeName': 'Klaus G', 'Initials': 'KG', 'LastName': 'Larsen', 'Affiliation': ""Larsen, Heldbo Reines, H. Lundbeck A/S, Copenhagen Valby, Denmark. Kennedy, Centre for Depression and Suicide Studies, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada. Thase, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Larsen, Heldbo Reines, H. Lundbeck A/S, Copenhagen Valby, Denmark. Kennedy, Centre for Depression and Suicide Studies, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada. Thase, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'Elin Heldbo', 'Initials': 'EH', 'LastName': 'Reines', 'Affiliation': ""Larsen, Heldbo Reines, H. Lundbeck A/S, Copenhagen Valby, Denmark. Kennedy, Centre for Depression and Suicide Studies, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada. Thase, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': ""Larsen, Heldbo Reines, H. Lundbeck A/S, Copenhagen Valby, Denmark. Kennedy, Centre for Depression and Suicide Studies, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada. Thase, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.""}]",Psychopharmacology bulletin,[]
2413,33012872,Lumateperone for the Treatment of Schizophrenia.,"Introduction


Schizophrenia is a severe psychotic disorder that is diagnosed by the presence of hallucinations or delusions along with disorganized speech, disorganized thought, or negative symptoms that are present for at least six months. Roughly 1 in 10,000 people a year are diagnosed with this psychiatric disorder. It is a chronic disorder requiring a lifetime of treatment of which antipsychotics have been the mainstay of this treatment. First-generation antipsychotics have dystonia, parkinsonism, and development of Tardive Dyskinesia as major side effects, and they are also nonspecific in terms of their actions. Second Generation antipsychotics target more specific dopamine and sometimes serotonin receptors with less dystonic side effects; however, there are additional concerns for the development of metabolic syndrome. This review aims to look at new medication on the market, lumateperone, for the treatment of Schizophrenia.
Recent studies


In one four week study with 60mg and 120mg of Lumateperone compared, 4mg of Risperdal, and a placebo found that Lumateperone significantly decreased the total Positive and Negative Syndrome Scale (PANSS) from baseline. Safety analysis of this study also found that Lumateperone was not associated with EPS or significant weight gain. Another study found that 42mg of Lumateperone significantly decreased PANSS score over placebo and 28mg of Lumateperone with associated TEAEs of somnolence, sedation, fatigue, and constipation. In an open-label safety, patients were switched from their current antipsychotic to Lumateperone and then switched back to their previous treatment after six weeks. PATIENTS were found to have statistically significant improvements in metabolic parameters, weight, and endocrine parameters, which were all lost when they were switched back to their previous treatment and their schizophrenic symptoms at pre-trial levels or improved them while on Lumateperone. In a continuation of the previous study over 12 months, 4 TEAEs occurred in 5% or more of the participants: diarrhea, dry mouth, weight decrease, and headache. Prolactin, metabolic labs, BMI, and weight all decreased as compared to the standard of care. Pooled studies revealed EPS related TEAEs were less frequent in patients receiving 42 mg lumateperone over Risperdal. Another pooled study looked at the safety profile; they found patients treated with lumateperone, two TEAEs occurred at twice the placebo rate and at a rate of 5% or more: dry mouth (5% vs. 2.2%) and sedation (24.1% vs. 10.0%) though TEAE discontinuation rates were lower than with Risperdal.
Summary


Taken together, data from these trials suggest that lumateperone can effectively treat positive symptoms, negative symptoms, and cognitive dysfunction in schizophrenia. Lumateperone entrance to the market introduces an innovative way to treat schizophrenia featuring both a novel mechanism of action and a markedly reduced side effect profile. Further research is needed to determine the efficacy of Lumateperone in treating bipolar disorder in addition to schizophrenia.",2020,Pooled studies revealed EPS related TEAEs were less frequent in patients receiving 42 mg lumateperone over Risperdal.,"['10,000 people a year are diagnosed with this psychiatric disorder']","['lumateperone', 'placebo', 'Lumateperone']","['Prolactin, metabolic labs, BMI, and weight', 'PANSS score', 'weight gain', 'TEAE discontinuation rates', 'somnolence, sedation, fatigue, and constipation', 'diarrhea, dry mouth, weight decrease, and headache', 'metabolic parameters, weight, and endocrine parameters', 'sedation', 'total Positive and Negative Syndrome Scale (PANSS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0340048,Pooled studies revealed EPS related TEAEs were less frequent in patients receiving 42 mg lumateperone over Risperdal.,"[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Edinoff', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'deBoisblanc', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Catherine Olivia', 'Initials': 'CO', 'LastName': 'Feltner', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Norder', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Vesela', 'Initials': 'V', 'LastName': 'Tzoneva', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Kaye', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Elyse M', 'Initials': 'EM', 'LastName': 'Cornett', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Kaye', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Viswanath', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Urits', 'Affiliation': 'Edinoff, Wu, Tzoneva, Louisiana State University Health Science Center Shreveport, Department of Psychiatry, and Behavioral Medicine. deBoisblanc, Feltner, Norder, Louisiana State University Shreveport School of Medicine. Kaye, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Department of Pharmacy Practice, Stockton, CA. Cornett, Kaye, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ. Urits, Louisiana State University Shreveport, Department of Anesthesiology, Shreveport, LA. Beth Israel Deaconess Medical Center, Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA.'}]",Psychopharmacology bulletin,[]
2414,33012918,Monocyte to High-Density Lipoprotein Ratio in Patients with Arteritic and Non-Arteritic Anterior Ischaemic Optic Neuropathy.,"The purpose of this study was to evaluate the monocyte to high-density lipoprotein (HDL) ratio (MHR) in patients with arteritic anterior ischaemic optic neuropathy (A-AION) and non-arteritic anterior ischaemic optic neuropathy (NA-AION). A total of 98 subjects were included in the study. Patients were divided into three groups: 16 patients with A-AION regarded as group one; 41 patients with NA-AION regarded as group two and 41 healthy subjects regarded as the control group. The MHR was calculated in all participants and compared between the patient and control groups. The mean age of subjects with A-AION, NA-AION and the control group were 75.9 ± 8.9 years, 67.1 ± 9.2 years, and 66.6 ± 6.7 years, respectively. Baseline clinical characteristics, such as diabetes mellitus and hypertension, were similar among groups. The mean MHR was significantly higher only in the A-AION group compared with the NA-AION and control group ( p  < .001), whereas there was no difference between NA-AION group and control group ( p  = .110). On receiver operating characteristic analysis, the area under the curve was 0.755, and the best cut- off value was 12.2 with a sensitivity of 72% and a specificity of 80%. An elevated MHR ratio is significantly associated with A-AION and MHR might be used to differentiate A-AION from NA-AION.",2020,"The mean MHR was significantly higher only in the A-AION group compared with the NA-AION and control group ( p  < .001), whereas there was no difference between NA-AION group and control group ( p  = .110).","['A total of 98 subjects were included in the study', 'Patients with Arteritic and Non-Arteritic Anterior Ischaemic Optic Neuropathy', 'mean age of subjects with A-AION, NA-AION and the control group were 75.9 ± 8.9 years, 67.1 ± 9.2 years, and 66.6 ± 6.7 years, respectively', 'Patients were divided into three groups: 16 patients with A-AION regarded as group one; 41 patients with NA-AION regarded as group two and 41 healthy subjects regarded as the control group', 'patients with arteritic anterior ischaemic optic neuropathy (A-AION) and non-arteritic anterior ischaemic optic neuropathy (NA-AION']",[],"['elevated MHR ratio', 'MHR', 'monocyte to high-density lipoprotein (HDL) ratio (MHR', 'mean MHR']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2242711', 'cui_str': 'Arteritic anterior ischemic optic neuropathy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751711', 'cui_str': 'Anterior ischemic optic neuropathy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",98.0,0.0125444,"The mean MHR was significantly higher only in the A-AION group compared with the NA-AION and control group ( p  < .001), whereas there was no difference between NA-AION group and control group ( p  = .110).","[{'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Koçak', 'Affiliation': 'Ophthalmology Department, Ondokuz Mayis University Hospital, Samsun, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Yeter', 'Affiliation': 'Ophthalmology Department, Ondokuz Mayis University Hospital, Samsun, Turkey.'}, {'ForeName': 'Inci', 'Initials': 'I', 'LastName': 'Güngör', 'Affiliation': 'Ophthalmology Department, Ondokuz Mayis University Hospital, Samsun, Turkey.'}]",Neuro-ophthalmology (Aeolus Press),['10.1080/01658107.2020.1733618']
2415,33012935,Is there a social cost of randomization?,"Randomized controlled trials, which randomly allocate benefits to a treatment group and not a control group, ascribe differences in post-treatment welfare to the benefits being allocated. However, it is possible that potential recipients' welfare is not only affected by the receipt of the program, but also by the allocation mechanism (procedural utility). In this paper, we ask whether potential recipients support or oppose random allocation of financial benefits, by allowing them to reward or punish an allocator conditional on her choice of allocation mechanism: direct allocation to one recipient vs. randomization among potential recipients. We find that when potential recipients have equal endowments, they on average reward the allocator for randomizing. When instead there is inequality in the potential recipients' endowments, the relatively poorer recipients punish allocators who randomize, while the relatively richer potential recipients neither reward nor punish the allocator for randomizing. Our results suggest that an allocator who chooses to randomize between potential recipients with unequal endowments imposes a social cost on the relatively poorer potential recipients.",2019,Our results suggest that an allocator who chooses to randomize between potential recipients with unequal endowments imposes a social cost on the relatively poorer potential recipients.,[],[],[],[],[],[],,0.0479161,Our results suggest that an allocator who chooses to randomize between potential recipients with unequal endowments imposes a social cost on the relatively poorer potential recipients.,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haushofer', 'Affiliation': 'Princeton University, Peretsman-Scully Hall, Princeton, NJ 08540, USA.'}, {'ForeName': 'Michala Iben', 'Initials': 'MI', 'LastName': 'Riis-Vestergaard', 'Affiliation': 'Princeton University, Peretsman-Scully Hall, Princeton, NJ 08540, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Busara Center for Behavioral Economics, Nairobi, Kenya.'}]",Social choice and welfare,['10.1007/s00355-018-1168-7']
2416,33012943,Stability Enhanced Variable Selection for a Semiparametric Model with Flexible Missingness Mechanism and Its Application to the ChAMP Study.,"This paper is motivated by the analytical challenges we encounter when analyzing the ChAMP (Chondral Lesions And Meniscus Procedures) study, a randomized controlled trial to compare debridement to observation of chondral lesions in arthroscopic knee surgery. The main outcome, WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score, is derived from the patient's responses to the questionnaire collected in the study. The major goal is to identify potentially important variables that contribute to this outcome. In this paper, the model of interest is a semiparametric model for the pain score. To address the missing data issue, we adopt a flexible missingness mechanism which is much more versatile in practice than a single parametric model. Then we propose a pairwise conditional likelihood approach to estimate the unknown parameter in the semiparametric model without the need of modeling its nonparametric counterpart nor the missingness mechanism. For variable selection we apply a regularization approach with a variety of stability enhanced tuning parameter selection methods. We conduct comprehensive simulation studies to evaluate the performance of the proposed method. We also apply the proposed method to the ChAMP study to demonstrate its usefulness.",2020,"The main outcome, WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score, is derived from the patient's responses to the questionnaire collected in the study.",['arthroscopic knee surgery'],[],['WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score'],"[{'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}]",[],"[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0211279,"The main outcome, WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score, is derived from the patient's responses to the questionnaire collected in the study.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois, United States.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Kluczynski', 'Affiliation': 'Department of Orthopaedics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Bisson', 'Affiliation': 'Department of Orthopaedics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}]",Journal of applied statistics,['10.1080/02664763.2019.1658727']
2417,33013028,Is intraoperative supplementation of dextrose essential for infants undergoing facial cleft surgeries?,"Background and Aims


Dextrose is commonly added to the intraoperative maintenance fluids of pediatric patients. The primary objective was to evaluate the effect of addition of 1% dextrose to Ringer's lactate (RL) on blood glucose levels in infants undergoing facial cleft surgeries.
Material and Methods


This prospective, randomized, single blinded study was conducted in forty infants undergoing either cheiloplasty or palatoplasty. Random blood sugar (RBS) was assessed using a glucometer after induction of anaesthesia, and at 1 and 2 hours later. Group R received RL and Group D received RL with 1% dextrose as intraoperative maintenance fluid. Hypoglycemia was defined as RBS <70 mg/dL and hyperglycemia as RBS >150 mg/dL.
Results


Baseline RBS levels and those at 60 min and 120 min post-induction were comparable in both groups. The increase in blood sugar levels from baseline to 60 min and to 120 min in each group was significant. Incidence of hyperglycemia was comparable in both groups. There were no episodes of hypoglycemia, intraoperatively.
Conclusion


Use of Ringer lactate alone or with addition of 1% dextrose resulted in comparable intraoperative blood sugar levels when used as maintenance fluid in infants undergoing facial cleft surgeries.",2020,The increase in blood sugar levels from baseline to 60 min and to 120 min in each group was significant.,"['infants undergoing facial cleft surgeries', 'forty infants undergoing either cheiloplasty or palatoplasty', 'pediatric patients']","['RL with 1% dextrose', 'Ringer lactate alone or with addition of 1% dextrose', ""dextrose to Ringer's lactate (RL""]","['episodes of hypoglycemia, intraoperatively', 'Random blood sugar (RBS', 'blood glucose levels', 'Hypoglycemia', 'blood sugar levels', 'intraoperative blood sugar levels', 'Incidence of hyperglycemia']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0685787', 'cui_str': 'Craniofacial cleft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",40.0,0.146398,The increase in blood sugar levels from baseline to 60 min and to 120 min in each group was significant.,"[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, India.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Barua', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, India.'}, {'ForeName': 'Pulak', 'Initials': 'P', 'LastName': 'Tosh', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_318_18']
2418,33013030,Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative analgesia in children undergoing inguinal hernia surgery: A comparative study.,"Background and Aims


Ultrasound-guided (USG) transversus abdominis plane (TAP) block has emerged as a safe and effective regional anesthesia technique as it provides adequate postoperative pain relief for lower abdominal surgeries. Caudal block is a gold standard technique in pediatric surgeries. Our aim was to compare the duration of postoperative analgesia between TAP block and caudal block in children undergoing inguinal hernia surgeries.
Material and Methods


In a prospective, randomized, controlled study, 112 children of age 2-8 years and ASA grade I and II, undergoing elective inguinal hernia surgery were randomly allocated into two groups: Group T ( n  = 56) received USG-guided TAP block with 0.5mL/kg of 0.2% ropivacaine and Group C ( n  = 56) received caudal block with 1mL/kg of 0.2% ropivacaine. The primary outcome variable was the duration of postoperative analgesia and the secondary outcome variables included variation in hemodynamic parameters and adverse effects, if any.
Results


There was no significant difference in median of CHEOPS score till 5 postoperative hours, thereafter till 24 postoperative hours, significantly lower CHEOPS score were found in Group T. Mean duration of analgesia was 523.44 ± 61.30 min in Group T, whereas in Group C, it was 352.59 ± 32.54 min. No significant difference was observed in hemodynamic variations and adverse effects.
Conclusion


TAP block and caudal block both are effective in providing postoperative analgesia in children undergoing inguinal herniotomy. USG-guided TAP block was found to be superior as it provided longer duration of analgesia and reduced rescue analgesic dose without any significant adverse effects as compared with caudal block after inguinal herniotomy.",2020,USG-guided TAP block was found to be superior as it provided longer duration of analgesia and reduced rescue analgesic dose without any significant adverse effects as compared with caudal block after inguinal herniotomy.,"['112 children of age 2-8 years and ASA grade I and II, undergoing elective inguinal hernia surgery', 'children undergoing inguinal hernia surgery', 'children undergoing inguinal hernia surgeries', 'children undergoing inguinal herniotomy', 'pediatric surgeries']","['TAP block and caudal block', 'USG-guided TAP block with 0.5mL/kg of 0.2% ropivacaine', 'Ultrasound-guided transversus abdominis plane block versus caudal block', 'caudal block with 1mL/kg of 0.2% ropivacaine', 'Ultrasound-guided (USG) transversus abdominis plane (TAP) block']","['median of CHEOPS score', 'duration of postoperative analgesia', 'CHEOPS score', 'hemodynamic variations and adverse effects', 'variation in hemodynamic parameters and adverse effects, if any']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0405600', 'cui_str': 'Simple excision of inguinal hernial sac'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",112.0,0.103361,USG-guided TAP block was found to be superior as it provided longer duration of analgesia and reduced rescue analgesic dose without any significant adverse effects as compared with caudal block after inguinal herniotomy.,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Dogra', 'Affiliation': 'Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_100_19']
2419,33013029,Enhancing cooperation during pediatric ultrasound: Oral midazolam versus conventional techniques.,"Background and Aims


Ultrasound is a safe and non-invasive method for detecting numerous pathologies. Pediatric patients are often uncooperative which leads to decreased quality and increased time of scan. We compared the conventional means alone and combination of oral midazolam for the above cited purpose.
Material and Methods


This double blind prospective study (CTRI/2016/06/007030) was conducted after obtaining due approval from institutional ethical committee. One hundred Children aged 2-6 years belonging to ASA class 1 or 2, posted for high resolution ultrasonography of abdomen were included in the study. They were randomised to receive midazolam 0.3 mg/kg mixed in 20 mL of apple juice (Group I) or 20 mL of apple juice alone (Group II) 20 minutes prior to the procedure. The parameters assessed were level of cooperation, sonologist's satisfaction, total scan time, heart rate and SpO 2 .
Results


Out of 100 patients, 44 patients of group I and 42 of group II were analysed. The cooperation score was significantly higher in Group I (35%) than Group II (19%). Likert scale revealed very satisfied and satisfied rating in 61.3% (Group I) and 21.4% (Group II). The time taken by sonologist and number of attempts were significantly less in Group I than Group II. There was no difference in discharge time between the groups. There was no reportable adverse event in either group.
Conclusion


Oral midazolam is a safe and effective agent to aid routine abdominal ultrasonography in pediatric patients.",2020,The time taken by sonologist and number of attempts were significantly less in Group I than Group II.,"['Pediatric patients', 'One hundred Children aged 2-6 years belonging to ASA class 1 or 2, posted for high resolution ultrasonography of abdomen were included in the study', '100 patients, 44 patients of group I and 42 of group II were analysed', 'pediatric patients']","['midazolam 0.3 mg/kg mixed in 20 mL of apple juice (Group I) or 20 mL of apple juice alone', 'conventional means alone and combination of oral midazolam', 'midazolam']","['cooperation score', 'quality and increased time of scan', ""level of cooperation, sonologist's satisfaction, total scan time, heart rate and SpO 2 "", 'time taken by sonologist and number of attempts', 'Likert scale revealed very satisfied and satisfied rating', 'discharge time']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",100.0,0.0537216,The time taken by sonologist and number of attempts were significantly less in Group I than Group II.,"[{'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Chaurasia', 'Affiliation': 'Department of Radiodiagnosis, Maharani Laxmi Bai Medical College, Jhansi, India.'}, {'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesiology, Maharani Laxmi Bai Medical College, Jhansi, India.'}, {'ForeName': 'Narendra Singh', 'Initials': 'NS', 'LastName': 'Sengar', 'Affiliation': 'Department of Nephrology, Maharani Laxmi Bai Medical College, Jhansi, India.'}, {'ForeName': 'Shivali', 'Initials': 'S', 'LastName': 'Pandey', 'Affiliation': 'Department of Anaesthesiology, Maharani Laxmi Bai Medical College, Jhansi, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_343_17']
2420,33013032,Cervical epidural analgesia combined with general anesthesia for head and neck cancer surgery: A randomized study.,"Background and Aims


The role of cervical epidural analgesia in head and neck cancer surgery is not fully explored. The aim of this study was to evaluate cervical epidural analgesia in terms of opioid and anesthetic requirements and stress response in patients undergoing head and neck cancer surgery.
Material and Methods


After institutional ethical committee approval and written informed consent, 30 patients undergoing elective head and neck cancer surgery were randomized into two groups: Group E (cervical epidural analgesia with general anesthesia), and group G (general anesthesia alone). In group E, an 18 gauge epidural catheter was placed at cervical (C) 6 - thoracic (T) 1 level. After test dose, a bolus of 10 ml of 0.2% ropivacaine was given followed by continuous infusion. Technique of general anesthesia and post-operative management was standardized in both the groups. Opioid and anesthetic drug requirement was observed. Blood glucose and serum cortisol levels were measured at baseline; post-incision and after surgery.
Results


There was significant reduction in the requirement of morphine ( P  < 0.001), isoflurane ( P  = 0.004) and vecuronium ( P  = 0.001) in group E. Post-operative, blood glucose and serum cortisol levels were significantly reduced ( P  = 0.0153 and 0.0074, respectively). Early post-operative pain was reduced with the lesser requirement of post-operative morphine.
Conclusions


The use of combined cervical epidural analgesia with general anesthesia reduces opioid, anesthetic drug requirement and stress response as compared to general anesthesia alone in patients undergoing head and neck cancer surgery.",2020,"There was significant reduction in the requirement of morphine ( P  < 0.001), isoflurane ( P  = 0.004) and vecuronium ( P  = 0.001) in group E. Post-operative, blood glucose and serum cortisol levels were significantly reduced (","['30 patients undergoing elective head and neck cancer surgery', 'patients undergoing head and neck cancer surgery', 'head and neck cancer surgery']","['ropivacaine', 'cervical epidural analgesia', 'isoflurane', 'vecuronium', 'Group E (cervical epidural analgesia with general anesthesia), and group G (general anesthesia alone', 'Cervical epidural analgesia combined with general anesthesia']","['blood glucose and serum cortisol levels', 'requirement of morphine', 'Blood glucose and serum cortisol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",30.0,0.0350124,"There was significant reduction in the requirement of morphine ( P  < 0.001), isoflurane ( P  = 0.004) and vecuronium ( P  = 0.001) in group E. Post-operative, blood glucose and serum cortisol levels were significantly reduced (","[{'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Kochhar', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India.'}, {'ForeName': 'Jahanara', 'Initials': 'J', 'LastName': 'Banday', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hamdard Institute of Medical Sciences and Research, New Delhi, India.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Ahmad', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Panjiar', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hamdard Institute of Medical Sciences and Research, New Delhi, India.'}, {'ForeName': 'Homay', 'Initials': 'H', 'LastName': 'Vajifdar', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hamdard Institute of Medical Sciences and Research, New Delhi, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_72_19']
2421,33013031,Efficacy of 0.5 mg/kg of propofol at the end of anesthesia to reduce the incidence of emergence agitation in children undergoing general anesthesia with sevoflurane.,"Background and Aims


Emergence agitation (EA) is a common transient behavioral disturbance after inhalational anesthesia and may cause harm to the patient. This study evaluated the efficacy of 0.5 mg/kg of propofol administered at the end of anesthesia to reduce the incidence of EA in children undergoing general inhalational anesthesia.
Material and Methods


This double-blind randomized clinical trial was done in children aged 1-5 years undergoing general anesthesia with sevoflurane. One hundred and eight subjects were included using consecutive sampling method and randomized into two equal groups. Propofol in the dose of 0.5 mg/kg was administered at the end of anesthesia to children in the propofol group, while those in the control group did not receive any intervention at the end of anesthesia. Incidence of EA, transfer time, postoperative hypotension, desaturation, and nausea-vomiting were observed. Aono and  Pediatric Anesthesia Emergence Delirium  scale were used to assess EA.
Results


Incidence of EA was 25.9% in the propofol group compared to 51.9% in the control group (RR = 0.500; 95% CI 0.298-0.840;  P  = 0.006). Mean transfer time in propofol group was longer (9.5 ± 3.9 min) than control group (7.8 ± 3.6 min) (mean difference 1.71 min; 95% CI 0.28-3.14;  P  = 0.020). Hypotension was found in one patient (1.9%) in propofol group, while in control group there was none. Nausea-vomiting was found in five patients (9.3%) in propofol group and eight patients (14.8%) in control. There was no desaturation in both the groups.
Conclusion


Administration of 0.5 mg/kg of propofol at the end of anesthesia effectively reduces the incidence of EA in children undergoing general inhalational anesthesia with sevoflurane.",2020,Mean transfer time in propofol group was longer (9.5 ± 3.9 min) than control group (7.8 ± 3.6 min) (mean difference 1.71 min; 95% CI 0.28-3.14;  P  = 0.020).,"['children aged 1-5 years undergoing general anesthesia with', 'children undergoing general inhalational anesthesia', 'One hundred and eight subjects', 'children undergoing general anesthesia with sevoflurane', 'children undergoing general inhalational anesthesia with sevoflurane']","['Propofol', 'propofol', 'sevoflurane']","['Mean transfer time', 'Incidence of EA', 'incidence of EA', 'Nausea-vomiting', 'Incidence of EA, transfer time, postoperative hypotension, desaturation, and nausea-vomiting', 'Hypotension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",108.0,0.159423,Mean transfer time in propofol group was longer (9.5 ± 3.9 min) than control group (7.8 ± 3.6 min) (mean difference 1.71 min; 95% CI 0.28-3.14;  P  = 0.020).,"[{'ForeName': 'Andi Ade Wijaya', 'Initials': 'AAW', 'LastName': 'Ramlan', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Dimas K Bonardo', 'Initials': 'DKB', 'LastName': 'Pardede', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Arif H M S', 'Initials': 'AHMS', 'LastName': 'Marsaban', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Hidayat', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Fildza Sasri', 'Initials': 'FS', 'LastName': 'Peddyandhari', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_257_19']
2422,33013033,Does an acute pain service improve the perception of postoperative pain management in patients undergoing lower limb surgery? A prospective controlled non-randomized study.,"Background and Aim


An acute pain service (APS) has been running in our institute since April 2013 and is managed by the Department of Anesthesia and Intensive Care. However, it is not clear to what extent the patients feel benefited from the APS. The aim of the study was to compare the perception of postoperative pain management in patients receiving care under APS with those receiving routine postoperative pain relief following lower limb surgery.
Material and Methods


This was a prospective, hospital-based, controlled non-randomized study. American Society of Anesthesiologists (ASA) grades I-III patients with age 18-75 years undergoing lower limb orthopedic surgery were prospectively recruited into APS (index group) or routine postoperative care (control group) ( n  = 55 each). Postoperatively, American Pain Society Patient Outcome Questionnaire-Revised (APS-POQ-R) and Short Form (SF-12) were used to evaluate the outcome of postoperative pain management at 24 h and health-related quality of life after 4 weeks respectively.
Results


Both groups were comparable in terms of demographic data. Patients in the index group had statistically significant better perception of care than the control group. Index group scored significantly higher than control group on median patient satisfaction score (9; interquartile range [IQR] [7-10] vs. 5 [3-6];  P  < 0.001). In index group, there was significant reduction of worst pain in first 24 h along with decreased frequency of severe pain.
Conclusion


Implementation of acute pain service plays an important role in improving the quality of postoperative pain relief, perception of care, and patient satisfaction.",2020,Patients in the index group had statistically significant better perception of care than the control group.,"['patients receiving care under APS with those receiving routine postoperative pain relief following lower limb surgery', 'American Society of Anesthesiologists (ASA) grades I-III patients with age 18-75 years undergoing lower limb orthopedic surgery', 'patients undergoing lower limb surgery', 'acute pain service (APS']",['APS (index group) or routine postoperative care (control group'],"['worst pain', 'frequency of severe pain', 'Postoperatively, American Pain Society Patient Outcome Questionnaire-Revised (APS-POQ-R) and Short Form (SF-12', 'postoperative pain management at 24 h and health-related quality of life', 'perception of care', 'median patient satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",,0.0662325,Patients in the index group had statistically significant better perception of care than the control group.,"[{'ForeName': 'Sukanya', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Kompal', 'Initials': 'K', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Jasveer', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Jindal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Saxena', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saroa', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Jannat', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Orthopaedics, Government Medical College and Hospital, Chandigarh, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_104_19']
2423,33013034,Continuous preperitoneal infusion of ropivacaine for postoperative analgesia in patients undergoing major abdominal or pelvic surgeries. A prospective controlled randomized study.,"Background and Aims


This study was conducted to compare continuous preperitoneal infusion (CPI) with continuous epidural infusion (CEI) of ropivacaine for pain relief and effect on pulmonary functions after major abdominal and pelvic surgeries.
Material and Methods


One hundred patients were randomized into two equal groups. Patients in CPI group ( n  = 50) received analgesia by continuous infusion of 0.2% ropivacaine, whereas those in the CEI group ( n  = 50) received continuous epidural infusion of 0.2% ropivacaine. The primary outcome was the first request of analgesia. The secondary outcome was the influence on the pulmonary functions.
Results


The time for the first request of analgesia was longer in the CPI group compared with that in the CEI group (7.3 ± 1.6 vs. 4.1 ± 1.1 h with  P  value = 0.001). The daily dose of morphine was lesser in CPI versus CEI group (11.3 ± 1 against 17.4 ± 0.9 mg). The pulmonary function tests were comparable except peak expiratory flow rate, which was better in CPI (170 ± 5.4) than CEI group (148.1 ± 5.8; with  P  value = 0.001).
Conclusion


Continuous preperitoneal infusion provides a superior analgesic effect than the continuous epidural infusion as regards delayed first request of analgesia, better pain scores, lesser usage of additional analgesics with better respiratory function.",2020,The time for the first request of analgesia was longer in the CPI group compared with that in the CEI group (7.3 ± 1.6 vs. 4.1 ± 1.1 h with  P  value = 0.001).,"['Material and Methods\n\n\nOne hundred patients', 'patients undergoing major abdominal or pelvic surgeries']","['continuous epidural infusion of 0.2% ropivacaine', 'continuous preperitoneal infusion (CPI) with continuous epidural infusion (CEI) of ropivacaine', 'ropivacaine', 'morphine', 'analgesia by continuous infusion of 0.2% ropivacaine']","['first request of analgesia', 'peak expiratory flow rate', 'pulmonary functions', 'time for the first request of analgesia', 'delayed first request of analgesia, better pain scores']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}]","[{'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",100.0,0.0946253,The time for the first request of analgesia was longer in the CPI group compared with that in the CEI group (7.3 ± 1.6 vs. 4.1 ± 1.1 h with  P  value = 0.001).,"[{'ForeName': 'Reem Abdelraouf', 'Initials': 'RA', 'LastName': 'ElSharkawy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Tamer Elmetwally', 'Initials': 'TE', 'LastName': 'Farahat', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelwahab', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Mansoura University, Egypt.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_333_18']
2424,33013035,Erector spinae plane block and transversus abdominis plane block for postoperative analgesia in cesarean section: A prospective randomized comparative study.,"Background and Aims


Erector spinae plane (ESP) block is an interfascial plane block given at the paraspinal region and provides effective visceral and somatic analgesia. Transversus abdominis plane (TAP) block is also an interfascial block that provides adequate somatic pain control. We conducted this study to compare the analgesic efficacy of ESP and TAP blocks with ropivacaine for 48 h after the cesarean section.
Material and Methods


Sixty patients scheduled for elective cesarean section under spinal anesthesia, randomly divided into ESP block ( n  = 30) or TAP block ( n  = 30) groups. After completion of surgery, ultrasound-guided ESP or TAP block was given using 0.2% ropivacaine (0.2 ml/kg on either side). Postoperatively visual analogue scale (VAS) score and analgesic requirement of each patient was assessed at regular interval for 48 h by a blinded investigator. Statistical analysis was done using SPSS version 21. Student's  t -test and Chi-square test were used for demographic and other data.
Results


ESP block provided prolonged analgesia compared to the TAP block, andthe mean time to first rescue analgesia was 43.53 h and 12.07 h, respectively ( P  < 0.001). The requirement for total analgesic was also significantly less in the ESP group compared to the TAP group ( P  < 0.001).
Conclusion


ESP block provided prolonged analgesia with a significant decrease in analgesic requirement compared to TAP block and can be used as a standard technique for post-cesarean analgesia.",2020,"The requirement for total analgesic was also significantly less in the ESP group compared to the TAP group ( P  < 0.001).
","['Sixty patients scheduled for elective cesarean section under spinal anesthesia', 'cesarean section']","['ultrasound-guided ESP or TAP block', 'Erector spinae plane block and transversus abdominis plane block', 'ropivacaine', 'ESP and TAP blocks with ropivacaine', 'ESP', 'Transversus abdominis plane (TAP) block', 'ESP block ( n  = 30) or TAP block', 'TAP']","['requirement for total analgesic', 'TAP block, andthe mean time to first rescue analgesia', 'analgesic requirement', 'Postoperatively visual analogue scale (VAS) score and analgesic requirement of each patient', 'analgesic efficacy']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0702786,"The requirement for total analgesic was also significantly less in the ESP group compared to the TAP group ( P  < 0.001).
","[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Malawat', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Verma', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, India.'}, {'ForeName': 'Durga', 'Initials': 'D', 'LastName': 'Jethava', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, India.'}, {'ForeName': 'Dharam Das', 'Initials': 'DD', 'LastName': 'Jethava', 'Affiliation': 'Department of Anesthesiology, Critical Care and Pain Management, Mahatma Gandhi Medical College and Hospital, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_116_19']
2425,33013037,Hyperbaric oxygen therapy as an adjuvant to standard therapy in the treatment of diabetic foot ulcers.,"Background and Aims


Chronic diabetic foot ulcers pose a major problem because of associated limb threatening complications. The aim of the present study was to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) as an adjuvant to standard therapy for treatment of diabetic foot ulcers.
Material and Methods


A total of 54 patients with diabetic foot ulcer of Wagner grade II-IV were recruited in this prospective, randomized, double blind study. Patients were randomized to receive HBOT along with standard therapy (group H;  n  = 28) or standard therapy alone (group S;  n  = 26). Patients were given 6 sessions per week for 6 weeks and followed up for 1 year. Outcomes were measured in terms of healing, and need for amputation, grafting or debridement. Parametric continuous variables were analyzed using Student unpaired  t -test and categorical variables were analyzed using Chi square test.
Results


The diabetic ulcers in 78% patients in Group H completely healed without any surgical intervention while no patient in group S healed without surgical intervention ( P  = 0.001). 2 patients in group H required distal amputation while in Group S, three patients underwent proximal amputation.
Conclusion


The present study shows that hyperbaric oxygen therapy is a useful adjuvant to standard therapy and is a better treatment modality if combined with standard treatment rather than standard treatment alone for management of diabetic foot ulcers.",2020,The diabetic ulcers in 78% patients in Group H completely healed without any surgical intervention while no patient in group S healed without surgical intervention ( P  = 0.001).,"['54 patients with diabetic foot ulcer of Wagner grade II-IV', 'diabetic foot ulcers']","['hyperbaric oxygen therapy', 'Hyperbaric oxygen therapy', 'hyperbaric oxygen therapy (HBOT', 'HBOT along with standard therapy (group H;  n  = 28) or standard therapy alone']","['distal amputation', 'healing, and need for amputation, grafting or debridement', 'diabetic ulcers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0441842', 'cui_str': 'Group H'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0743150', 'cui_str': 'Diabetic ulcer'}]",54.0,0.0902695,The diabetic ulcers in 78% patients in Group H completely healed without any surgical intervention while no patient in group S healed without surgical intervention ( P  = 0.001).,"[{'ForeName': 'Atit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, UPUMS, Saifai, Uttar Pradesh, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Department of Anaesthesiology, UPUMS, Saifai, Uttar Pradesh, India.'}, {'ForeName': 'Tallamraju', 'Initials': 'T', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Anaesthesiology, Vivekanand Polyclinic and Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Dhiraj', 'Initials': 'D', 'LastName': 'Srivastava', 'Affiliation': 'Department of Community Medicine, UPUMS, Saifai, Uttar Pradesh, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_94_19']
2426,33013036,Sphenopalatine ganglion block: Intranasal transmucosal approach for anterior scalp blockade - A prospective randomized comparative study.,"Background and Aims


Peripheral nerve blocks in neurosurgical practice attenuate most stressful responses like pin insertion, skin, and dural incision. Scalp block is conventionally the blockade of choice. Further studies for less invasive techniques are required. Intranasal transmucosal block of the sphenopalatine ganglion has shown promising results in patients with chronic headache and facial pain. The primary objective of our study was to compare the gold standard scalp block and bilateral sphenopalatine ganglion block (nasal approach) for attenuation of hemodynamic response to pin insertion. Secondary objectives included hemodynamic response to skin and dural incision.
Material and Methods


After IRB approval and informed consent, a prospective randomized comparative study was carried out on 50 adult patients undergoing elective supratentorial surgery. The hemodynamic response to pin insertion, skin incision, and dural incision was noted in both the groups. The data was analyzed with NCSS version 9.0 statistical software.
Results


The HR and MAP were comparable between the groups. Following dural incision MAP was significantly lower at 1,2,3,4,5 and 10 min in group SPG whereas in group S it was significantly lower at 1 and 2min. ( P  = 0.02 at T1,  P  = 0.03 at T2).
Conclusions


Concomitant use of bilateral SPG block with general anesthesia is an effective and safe alternative technique to scalp blockade for obtundation of hemodynamic responses due to noxious stimulus during craniotomy surgeries.",2020,"Following dural incision MAP was significantly lower at 1,2,3,4,5 and 10 min in group SPG whereas in group S it was significantly lower at 1 and 2min.","['50 adult patients undergoing elective supratentorial surgery', 'patients with chronic headache and facial pain']","['sphenopalatine ganglion', 'Sphenopalatine ganglion block', 'gold standard scalp block and bilateral sphenopalatine ganglion block (nasal approach', 'Intranasal transmucosal approach']","['hemodynamic response to skin and dural incision', 'HR and MAP', 'hemodynamic response to pin insertion, skin incision, and dural incision']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0151293', 'cui_str': 'Chronic Headache'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}]","[{'cui': 'C0229062', 'cui_str': 'Structure of sphenopalatine ganglion'}, {'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1513727', 'cui_str': 'Transmucosal route'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]",50.0,0.0411805,"Following dural incision MAP was significantly lower at 1,2,3,4,5 and 10 min in group SPG whereas in group S it was significantly lower at 1 and 2min.","[{'ForeName': 'Narmada', 'Initials': 'N', 'LastName': 'Padhy', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Srilata', 'Initials': 'S', 'LastName': 'Moningi', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Dilip K', 'Initials': 'DK', 'LastName': 'Kulkarni', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Alugolu', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Inturi', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Gopinath', 'Initials': 'G', 'LastName': 'Ramachandran', 'Affiliation': ""Department of Anesthesia and Intensive Care, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_249_18']
2427,33013041,Dexmedetomidine vs dexamethasone as an adjuvant to 0.5% ropivacaine in ultrasound-guided supraclavicular brachial plexus block.,"Background and Aims


Both dexmedetomidine and dexamethasone have individually been shown to be beneficial as an adjuvant to ropivacaine. We compared the efficacy of combination of ropivacaine with dexmedetomidine and ropivacaine with dexamethasone in ultrasound-guided supraclavicular brachial plexus (SCBP) block.
Material and Methods


In this prospective randomised double-blind controlled trial, 60 ASA physical status I/II patients undergoing elective upper-limb surgery under ultrasound-guided SCBP block with 30 ml of 0.5% ropivacaine were randomised into three groups. Group 1 ( n  = 20) received 1 μg/kg of dexmedetomidine, and group 2 ( n  = 20) received 8 mg of dexamethasone in addition to ropivacaine, while group 3 ( n  = 20) received only ropivacaine. The primary outcomes studied were onset and duration of sensory and motor block. Secondary outcomes included duration of analgesia, total analgesic consumption in 24 h postoperatively and quality of block. ANOVA and Chi-square test were used to compare results on continuous measurements and categorical measurements, respectively.
Results


Onset of sensory and motor block was faster in group 1 (13.5 ± 4.1 and 17.0 ± 4.1 min) and group 2 (15.6 ± 3.6 and 18.5 ± 3.7 min) as compared to group 3 (20.1 ± 5.3 and 24.9 ± 5.6 min;  P  < 0.001). Block duration was significantly longer in group 1 and group 2 than in group 3. Duration of analgesia was prolonged in group 1 and 2 (1218.0 ± 224.6 and 1128.0 ± 207.5 min, respectively) as compared to group 3 (768.0 ± 273.7 min;  P  < 0.001). Twenty-four hours analgesic consumption postoperatively was reduced in the two study groups.
Conclusion


Both dexmedetomidine and dexamethasone when used as adjuvants to ropivacaine for SCBP block, block onset time, and prolong' block duration.",2020,Block duration was significantly longer in group 1 and group 2 than in group 3.,"['60 ASA physical status I/II patients undergoing', 'ultrasound-guided supraclavicular brachial plexus block']","['dexmedetomidine and ropivacaine with dexamethasone', 'ropivacaine', 'Dexmedetomidine vs dexamethasone', 'dexmedetomidine', 'elective upper-limb surgery under ultrasound-guided SCBP block with 30 ml of 0.5% ropivacaine', 'dexamethasone in addition to ropivacaine', 'dexmedetomidine and dexamethasone']","['onset and duration of sensory and motor block', 'sensory and motor block', 'Block duration', 'duration of analgesia, total analgesic consumption in 24 h postoperatively and quality of block', ""SCBP block, block onset time, and prolong' block duration"", 'Duration of analgesia']","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]",60.0,0.144651,Block duration was significantly longer in group 1 and group 2 than in group 3.,"[{'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Kathuria', 'Affiliation': 'Department of Anaesthesia, Dayanand Medical College, Ludhiana, Punjab, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_176_19']
2428,33013040,Evaluation of King's vision videolaryngoscope and glidescope on hemodynamic stress response to laryngoscopy and endotracheal intubation.,"Background and Aims


We hypothesis that the use of novel airway devices would decrease hemodynamic stress response (HDSR) to laryngoscopy and endotracheal (ET) intubation. The aim of our study was to evaluate the hemodynamic stress response (HDSR) to laryngoscopy and tracheal intubation using the King vision video laryngoscope (KVVL) versus glidescope (GLS).
Material and Methods


A prospective randomized, comparative study that was conducted on 80 patients of both sexes; American Society of Anesthesiologists physical status I and II with no anticipated difficult airway, aged 20-60 years; who were scheduled for elective surgical procedure under general anesthesia. Patients were randomly allocated into two groups (40 each). Group I: laryngoscopy and tracheal intubation were carried out using KVVL, Group II: laryngoscopy and tracheal intubation were carried out using GLS. The two groups were compared for noninvasive hemodynamic data such as heart rate and mean arterial pressure. Time to successful intubation and number of attempts were recorded. Hemodynamic parameters were recorded at the preinduction, after induction, at intubation, 1 min, 3 min, 5 min, 10 min, and 15 min.
Results


There was significant decrease ( P  < 0.05) in HR and MBP in both groups just before intubation. In comparison with the baseline, HR and MBP in group I and group II increased but this difference was not significant at 3 min and 5 min after intubation and returned to the baseline at 10 min after intubation and below the baseline at 15 min after intubation. Also, there were no significant differences in the hemodynamic response between the studied groups.
Conclusion


Novel airway devices either KVVL or GLS are efficient in reducing HDSR to laryngoscopy and ET intubation.",2020,"In comparison with the baseline, HR and MBP in group I and group II increased but this difference was not significant at 3 min and 5 min after intubation and returned to the baseline at 10 min after intubation and below the baseline at 15 min after intubation.","['80 patients of both sexes; American Society of Anesthesiologists physical status I and II with no anticipated difficult airway, aged 20-60 years; who were scheduled for elective surgical procedure under general anesthesia']","['laryngoscopy and endotracheal (ET) intubation', 'laryngoscopy and tracheal intubation using the King vision video laryngoscope (KVVL) versus glidescope (GLS', 'KVVL, Group II: laryngoscopy and tracheal intubation were carried out using GLS', 'laryngoscopy and endotracheal intubation', 'KVVL or GLS', 'laryngoscopy and tracheal intubation', ""King's vision videolaryngoscope and glidescope""]","['Time to successful intubation and number of attempts', 'hemodynamic stress response (HDSR', 'Hemodynamic parameters', 'hemodynamic stress response', 'HR and MBP', 'noninvasive hemodynamic data such as heart rate and mean arterial pressure', 'hemodynamic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014063', 'cui_str': 'Myelin basic protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",80.0,0.0381914,"In comparison with the baseline, HR and MBP in group I and group II increased but this difference was not significant at 3 min and 5 min after intubation and returned to the baseline at 10 min after intubation and below the baseline at 15 min after intubation.","[{'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'El-Shmaa', 'Affiliation': 'Department of Anesthesia and Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_183_18']
2429,33013042,Hemodynamic changes under spinal anesthesia after elastic wrapping or pneumatic compression of lower limbs in elective cesarean section: A randomized control trial.,"Background and Aims


In spite of adequate fluid loading and left lateral tilt, parturients develop hypotension under spinal anesthesia during cesarean section. Elastic crepe bandage (CB) or pneumatic compression device (PCD) can be utilized to prevent the pooling of blood in lower limbs and thereby it may reduce the incidence of hypotension in these patients. This study was formulated to analyze the hemodynamic effects of leg wrapping with elastic CB and PCD in parturients undergoing for cesarean section under anesthesia.
Material and Methods


Ninety term obstetric patients posted for elective cesarean section under spinal anesthesia were randomized into 3 groups: Group 1 (control), Group 2 (CB), and Group 3 (PCD). All the parturients had their legs wrapped with an elastic bandage and pneumatic sleeve applied over it. In Group 1 (Control), patients had their legs wrapped with CB loosely and pneumatic sleeve also applied was switched on. In Group 2, patients the CB was applied by stretching the bandage (15 cm width and 4 m stretched length). The PCD was not switched on in this group. In Group 3, the legs were wrapped with the CB loosely. The pneumatic sleeve was applied over the bandage, and the machine was switched on with a preset pressure of 40-50 mmHg after spinal anesthesia. Incidence of maternal hypotension and ephedrine requirement to maintain systolic blood pressure, neonatal Apgar score were recorded.
Results


The incidence of hypotension was significantly lower in Group 2 and 3 than the control group. Similarly, the requirement of ephedrine was significantly high in control group compared to CB and PCD. The incidence of hypotension was lower in group CB than group PCD. Meantime to receive the first dose of ephedrine was significantly low in control (7.37 ± 4.94 min) as compared to CB (10 ± 2.8 min) and PCD (13.88 ± 9.23).
Conclusion


Leg-wrapping with CB is cost-effective, non-invasive, non-pharmacological, and effective tool to reduce the incidence of hypotension after spinal anesthesia in a parturient.",2020,The incidence of hypotension was lower in group,"['parturients undergoing for cesarean section under anesthesia', 'Material and Methods\n\n\nNinety term obstetric patients posted for elective cesarean section under spinal anesthesia', 'elective cesarean section', 'parturients develop hypotension under spinal anesthesia during cesarean section']","['pneumatic sleeve', 'ephedrine', 'CB', 'leg wrapping with elastic CB and PCD', 'Elastic crepe bandage (CB) or pneumatic compression device (PCD', 'elastic bandage and pneumatic sleeve', 'spinal anesthesia after elastic wrapping or pneumatic compression']","['incidence of hypotension', 'Incidence of maternal hypotension and ephedrine requirement to maintain systolic blood pressure, neonatal Apgar score']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]","[{'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0460462', 'cui_str': 'Cotton crepe bandage'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0445414', 'cui_str': 'Wrapping'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",90.0,0.0265479,The incidence of hypotension was lower in group,"[{'ForeName': 'Krishnamoorthy Retnamma', 'Initials': 'KR', 'LastName': 'Prajith', 'Affiliation': 'Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (SBV) (Deemed to be University), Pillayarkuppam, Puducherry, India.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Mishra', 'Affiliation': 'Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (SBV) (Deemed to be University), Pillayarkuppam, Puducherry, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ravishankar', 'Affiliation': 'Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (SBV) (Deemed to be University), Pillayarkuppam, Puducherry, India.'}, {'ForeName': 'Vadlamudi Reddy', 'Initials': 'VR', 'LastName': 'Hemanth Kumar', 'Affiliation': 'Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (SBV) (Deemed to be University), Pillayarkuppam, Puducherry, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_72_18']
2430,33013044,"Effect of dexmedetomidine on attenuation of hemodynamic response to intubation, skin incision, and sternotomy in coronary artery bypass graft patients: A double-blind randomized control trial.","Background and Aims


Coronary artery bypass grafting (CABG) surgery involves various noxious stimuli resulting in stress response, which in turn increases the risk of perioperative myocardial ischemia. The present study was conducted to evaluate the effect of dexmedetomidine on the attenuation of hemodynamic response to intubation, skin incision, and sternotomy in CABG surgery.
Material and Methods


Sixty patients were randomized into two groups of 30 each. Group D patients received dexmedetomidine 1 μg/kg as loading dose over 10 min, followed by continuous infusion of 0.5 μg/kg/h. In group P, normal saline was infused as loading and maintenance dose at similar rate. Hemodynamic parameters, total induction dose of thiopentone, and adverse effects were recorded. Statistical analysis was performed using SPSS version 20.0. Chi-square test and ANNOVA test were used and  P  < 0.05 was considered significant.
Results


The percentage increase in heart rate was significantly lesser in group D than group P after intubation (7.04% v/s 15.08%), skin incision (5.91% v/s 10.11%), and sternotomy (5.33% v/s 11.65%). Similarly increase in systolic, diastolic, and mean blood pressure were significantly lesser in group D than group P after intubation, skin incision, and sternotomy. There was a significant reduction of mean total of thiopentone in group D in comparison to group P. (1.16 mg/kg v/s 2.44 mg/kg) ( P <0.001).
Conclusion


Dexmedetomidine resulted in significant attenuation of hemodynamic response to intubation, skin incision, and sternotomy in CABG surgery without significant adverse effects. It also significantly reduced the dose of thiopentone required for induction.",2020,"Similarly increase in systolic, diastolic, and mean blood pressure were significantly lesser in group D than group P after intubation, skin incision, and sternotomy.","['Material and Methods\n\n\nSixty patients', 'coronary artery bypass graft patients']","['Dexmedetomidine', 'thiopentone', 'Coronary artery bypass grafting (CABG) surgery', 'dexmedetomidine']","['Hemodynamic parameters, total induction dose of thiopentone, and adverse effects', 'mean total of thiopentone', 'hemodynamic response to intubation, skin incision, and sternotomy', 'systolic, diastolic, and mean blood pressure', 'heart rate', 'skin incision', 'hemodynamic response']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.193768,"Similarly increase in systolic, diastolic, and mean blood pressure were significantly lesser in group D than group P after intubation, skin incision, and sternotomy.","[{'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Singariya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Kumari', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Paliwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Ujwal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}]","Journal of anaesthesiology, clinical pharmacology",['10.4103/joacp.JOACP_353_18']
2431,33013107,Efficacy of Adjuvant Systemic Chemotherapy Combined with Radical Surgery and Hyperthermic Intraperitoneal Chemotherapy in Gastric Cancer Treatment.,"Evaluation of the efficacy of the combination of radical surgery, hyperthermic intraperitoneal chemotherapy (HIPEC), and adjuvant systemic chemotherapy (ACT) in reducing gastric cancer progression in patients with resectable serosa-invasive gastric cancer in a single institution. In 2015-2016, 19 patients with gastric cancer (stage IIB-IIIC) were included in the trial. The trial protocol comprised radical surgery, HIPEC (cisplatin 50 mg/m 2  + doxorubicin 50 mg/m 2 , 42 °C, 1 hour), and 1-8 cycles of ACT (oxaliplatin 100 mg/m 2  administered on day 1 of each cycle and oral capecitabine 1000 mg/m 2  (or tegafur 10-15 mg/kg) administered twice daily on days 1-14 of each cycle with an interval of 7 days between cycles). Following the ACT treatment, the patients were divided into 2 subgroups-those who underwent up to 6 ACT cycles (1-6 cycles, subgroup ≤ 6-8 patients) and those who underwent 7-8 ACT cycles (subgroup > 6-11 patients). Three-year metastasis-free survival (MFS) for the > 6 subgroup was 91 ± 9%. With a follow-up median of 17 months, 3-year MFS for the ≤ 6 subgroup was not reached -  p   log-rank  = 0.003. The trial showed that in managing advanced gastric cancer patients (pT4a-4bN0-3 M0) by supplementing radical surgery with ACT-enhanced hyperthermic intraperitoneal chemotherapy, ACT proved to be highly effective when administered in its full mode of 7-8 cycles compared with its truncated variant of 1-6 cycles.",2020,"With a follow-up median of 17 months, 3-year MFS for the ≤ 6 subgroup was not reached -  p   log-rank  = 0.003.","['patients with resectable serosa-invasive gastric cancer in a single institution', 'advanced gastric cancer patients (pT4a-4bN0-3\xa0M0', 'Gastric Cancer Treatment', '1000', 'In 2015-2016, 19 patients with gastric cancer (stage IIB-IIIC']","['Adjuvant Systemic Chemotherapy Combined with Radical Surgery and Hyperthermic Intraperitoneal Chemotherapy', 'radical surgery, hyperthermic intraperitoneal chemotherapy (HIPEC), and adjuvant systemic chemotherapy (ACT', 'ACT (oxaliplatin', 'supplementing radical surgery with ACT-enhanced hyperthermic intraperitoneal chemotherapy, ACT', 'doxorubicin', 'capecitabine', 'radical surgery, HIPEC (cisplatin 50']","['3-year MFS', 'year metastasis-free survival (MFS', 'gastric cancer progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036760', 'cui_str': 'Serous membrane structure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",19.0,0.108319,"With a follow-up median of 17 months, 3-year MFS for the ≤ 6 subgroup was not reached -  p   log-rank  = 0.003.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Reutovich', 'Affiliation': 'Gastroesophageal Pathology Department, N.N. Alexandrov National Cancer Center of Belarus, Lesnoy, 223040 Minsk Region Republic of Belarus.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Krasko', 'Affiliation': 'United Institute of Informatics Problems of the National Academy of Sciences of Belarus, 6, Surganov Str., 220012 Minsk, Republic of Belarus.'}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Sukonko', 'Affiliation': 'N.N. Alexandrov National Cancer Center of Belarus, Lesnoy, 223040 Minsk Region Republic of Belarus.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01102-w']
2432,33013113,Early Outcome of Enhanced Recovery Programs Versus Conventional Perioperative Care in Elective Open Left Side Colonic Carcinoma Surgery: Analysis of 80 Cases.,"According to recent clinical practice guidelines, enhanced recovery programs (ERP) have been practiced to improve surgical outcomes and decrease cost. However, these are still opposed by the traditional measures in the treatment of colorectal carcinoma that is still practiced with the concept of protection of anastomosis and decrease postoperative complications. The aim of this study was to report our experience in ERP in elective open left side colonic carcinoma surgery in comparison with the conventional perioperative care. The current prospective multicenter randomized controlled study included a total of 80 adult patients with left side colonic cancer who were eligible for elective colonic resection. Included patients were randomly divided into two equal groups: group (A) where conventional perioperative care was performed and group (B) where ERP were applied. Follow-up was designed for at least 1 month to evaluate and compare hospital stay and postoperative complications. There was no statistically significant difference between the two groups as regards demographic data and preoperative comorbidities. There were statistically significant less pain ( P  = 0.24), less postoperative nausea and vomiting ( P  = 0.045), and less hospital stay ( P  < 0.001) in group B than group A. Otherwise, there was no statistically significant difference in comparing the rest of postoperative surgical or non-surgical complications or rates of readmissions between the two groups. ERP are safe, reliable, simple, and applicable in open left side cancer colon surgery with no negative impact over the postoperative complications in comparison with the conventional care.",2020,"There were statistically significant less pain ( P  = 0.24), less postoperative nausea and vomiting ( P  = 0.045), and less hospital stay ( P  < 0.001) in group B than group A. Otherwise, there was no statistically significant difference in comparing the rest of postoperative surgical or non-surgical complications or rates of readmissions between the two groups.","['80 adult patients with left side colonic cancer who were eligible for elective colonic resection', 'Elective Open Left Side Colonic Carcinoma Surgery']","['conventional perioperative care', 'Enhanced Recovery Programs', 'Conventional Perioperative Care']","['hospital stay', 'postoperative nausea and vomiting', 'demographic data and preoperative comorbidities', 'rest of postoperative surgical or non-surgical complications or rates of readmissions', 'hospital stay and postoperative complications', 'pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0699790', 'cui_str': 'Carcinoma of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.0191368,"There were statistically significant less pain ( P  = 0.24), less postoperative nausea and vomiting ( P  = 0.045), and less hospital stay ( P  < 0.001) in group B than group A. Otherwise, there was no statistically significant difference in comparing the rest of postoperative surgical or non-surgical complications or rates of readmissions between the two groups.","[{'ForeName': 'Emad M', 'Initials': 'EM', 'LastName': 'Abd ElRahman', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Kharoub', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shora', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Emara', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'M Ashraf', 'Initials': 'MA', 'LastName': 'Balbaa', 'Affiliation': 'General Surgery Department, Faculty of Medicine, Menoufia University, Shebin El Kom, Egypt.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01074-x']
2433,33013114,Single-Dose Prophylactic Antibiotic Versus Extended Usage for Four Days in Clean-Contaminated Oncological Surgeries: a Randomized Clinical Trial.,"The optimal duration of prophylactic antimicrobial usage in clean-contaminated elective oncological surgeries is not clear. This single-center randomized trial evaluated the effectiveness of single-dose antimicrobial prophylaxis in clean-contaminated surgeries for the reduction of surgical site infection (SSI). Between April 2018 and January 2019, 315 patients undergoing major oncological clean-contaminated surgeries where the gastrointestinal or genital tract was opened under controlled conditions were randomized into 2 groups i.e., single dose versus extended dose groups. The single dose group received a 1.5 g dose of cefuroxime immediately before surgery while the extended group received the same dose of cefuroxime thrice daily for 4 days from the day of surgery till postoperative day 3. In addition, patients undergoing esophageal and colorectal surgeries received metronidazole. The overall SSI rate of the single dose group was not significantly different from that of the extended group (11.3% vs. 14.7%, respectively,  p  0.40), with absolute difference of 3.4% and relative risk of 0.85 (95% C.I, 0.59 to 1.22). The rate of remote site infection was also not different between the two groups (14.4% vs 10.2%,  p  0.31) with absolute difference of 4.2% and relative risk 1.19 (95% C.I, 0.89 to 1.59). In univariate analysis, parameters like nodal dissection, colorectal surgery, smoking, and hospital stay were significantly associated with SSI. In multivariate analysis, age, smoking, nodal dissection, and hospital stay retained significance. Single-dose antimicrobial prophylaxis is as effective as extended usage for 4 days in the prevention of postoperative SSI in patients undergoing clean-contaminated major oncological surgeries. Trial was registered with the clinical trial registry of India (CTRI/2018/06/014344).",2020,Single-dose antimicrobial prophylaxis is as effective as extended usage for 4 days in the prevention of postoperative SSI in patients undergoing clean-contaminated major oncological surgeries.,"['Clean-Contaminated Oncological Surgeries', 'clean-contaminated surgeries for the reduction of surgical site infection (SSI', 'patients undergoing clean-contaminated major oncological surgeries', 'Between April 2018 and January 2019, 315 patients undergoing major oncological clean-contaminated surgeries where the gastrointestinal or genital tract was opened under controlled conditions', 'patients undergoing esophageal and colorectal surgeries', 'clean-contaminated elective oncological surgeries']","['single-dose antimicrobial prophylaxis', 'cefuroxime', 'Single-Dose Prophylactic Antibiotic', 'metronidazole']","['rate of remote site infection', 'parameters like nodal dissection, colorectal surgery, smoking, and hospital stay', 'overall SSI rate']","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",315.0,0.181015,Single-dose antimicrobial prophylaxis is as effective as extended usage for 4 days in the prevention of postoperative SSI in patients undergoing clean-contaminated major oncological surgeries.,"[{'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Nusrath', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Dasu', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Subramanyeshwar Rao', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'K V V N', 'Initials': 'KVVN', 'LastName': 'Raju', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Basanth Kumar', 'Initials': 'BK', 'LastName': 'Rayani', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Vibhavari Milind', 'Initials': 'VM', 'LastName': 'Naik', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Sujit C', 'Initials': 'SC', 'LastName': 'Patnaik', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rajagopalan Iyer', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Ajesh Raj', 'Initials': 'AR', 'LastName': 'Saksena', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramanuja Rao', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Saifuddin', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Harini', 'Initials': 'H', 'LastName': 'Narayanan', 'Affiliation': 'Department of Anaesthesiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Radha Rani', 'Initials': 'RR', 'LastName': 'Dandamudi', 'Affiliation': 'Department of Microbiology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Clinical Research, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.'}]",Indian journal of surgical oncology,['10.1007/s13193-020-01163-x']
2434,33013260,"Effects of vitamin D3 supplementation on clinical symptoms, quality of life, serum serotonin (5-hydroxytryptamine), 5-hydroxy-indole acetic acid, and ratio of 5-HIAA/5-HT in patients with diarrhea-predominant irritable bowel syndrome: A randomized clinical trial.","Vitamin D deficiency, common in the population with irritable bowel syndrome (IBS), can induce the main factors that lead to IBS clinical symptoms, such as depression, anxiety, and inflammation. Serotonin (5-HT) plays an important role in the pathophysiology of IBS, and its production and secretion are increased from the lumen due to stress and inflammation. The aim of this study was to evaluate the effect of vitamin D3 supplementation on the pathogenesis of diarrhea-predominant IBS (IBS-D). Seventy-four IBS-D patients (age: 18-65 y) participated in a randomized, double-blind, placebo-controlled trial study from February 2017 to May 2018, at Rasoul-e-Akram Hospital, Tehran, Iran. Subjects were allocated into two groups receiving 50,000 IU/week of vitamin D3 or placebo for 9 weeks. IBS severity score system (IBS-SSS), IBS-quality of life questionnaire (QoL), hospital anxiety and depression Scale (HADs), visceral sensitivity index (VSI) and serum 25(OH) vitamin D3, serotonin, 5-hydroxy-indole acetic acid and ratio of 5-HIAA/5-HT were evaluated before and after the interventions. Symptoms severity, QoL, HADs-depression, and VSI score improved significantly in the vitamin D group as compared to the placebo group (P-values: <0.001, 0.049, 0.023, and 0.008; respectively). There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study. Based on our results, we recommend serum vitamin D be evaluated in the process of treatment of these patients to ameliorate symptoms and quality life of IBS-D patients with vitamin D deficiency and/or insufficiency.",2020,"There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study.","['patients with diarrhea-predominant irritable bowel syndrome', 'population with irritable bowel syndrome (IBS', 'Seventy-four IBS-D patients (age: 18-65 y', 'IBS-D patients with vitamin D deficiency and/or insufficiency', 'controlled trial study from February 2017 to May 2018, at Rasoul-e-Akram Hospital, Tehran, Iran']","['Serotonin (5-HT', 'vitamin D', 'vitamin D3 or placebo', 'placebo', 'vitamin D3 supplementation']","['clinical symptoms, quality of life, serum serotonin (5-hydroxytryptamine), 5-hydroxy-indole acetic acid, and ratio of 5-HIAA/5-HT', 'diarrhea-predominant IBS (IBS-D', 'abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT', 'IBS severity score system (IBS-SSS), IBS-quality of life questionnaire (QoL), hospital anxiety and depression Scale (HADs), visceral sensitivity index (VSI) and serum 25(OH) vitamin D3, serotonin, 5-hydroxy-indole acetic acid and ratio of 5-HIAA/5-HT', 'Symptoms severity, QoL, HADs-depression, and VSI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020361', 'cui_str': '5-hydroxyindole acetic acid'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.14901,"There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Khalighi Sikaroudi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'AmirHossein', 'Initials': 'A', 'LastName': 'Faghihi Kashani', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Masoodi', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dehnad', 'Affiliation': 'Department of English Language, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Shidfar', 'Affiliation': 'Worcester Memorial Hospital, University of Massachusetts, Worcester, U.S.A.'}]",EXCLI journal,['10.17179/excli2020-2247']
2435,33013294,Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study.,"Osteopathic manipulative treatment (OMT) has been demonstrated to be an effective therapy in several clinical conditions and age groups. Despite the clinical effectiveness, lack of robust data in terms of neurobiological, specifically autonomic, mechanisms of action is observed. Preliminary studies showed a parasympathetic effect leading to a trophotropic effect of OMT. However, these data are limited to heart rate variability (HRV) analysis. In order to study further the role of OMT on the autonomic nervous system, a cross-over randomized controlled trial RCT has been designed to test the effect of osteopathic treatment compared to sham therapy on a range of autonomic parameters. Thermal images, HRV and skin conductance data were collected on a sample of healthy adults. The study design consisted of two sessions (OMT and SHAM), 1 treatment per week, lasting 35 min each, composed of 5 min of baseline, 25 min of treatment, and 5 min of post-touch. During the baseline and the post-treatment, participants received no touch. Thirty-seven participants (aged 27 ± 5 years old, male ratio 40%) completed the study. Multivariate analysis showed a significant parasympathetic effect of group as well as of epoch on thermographic data of the nose (estimate 0.38; 95% CI 0.12-0.63;  p  < 0.01), left (0.17; 0.06-0.27; <0.001) and right (0.16; 0.07-0.24; <0.001) perioral as well as on the forehead (0.07; 0.01-0.12; <0.01) regions but not for the chin (0.08; -0.02 to 0.18; 0.13). Consistent with a parasympathetic effect, analyses demonstrated a difference between OMT and sham groups on the nuHF ( p  < 0.001) and DFA-a1 ( p  < 0.01) as well as on skin conductance (<0.01). The present research supports the hypothesis that a single session of OMT as compared to sham induces autonomic consequences in healthy non-symptomatic adults. Clinicaltrial.gov identifier: NCT03888456, https://clinicaltrials.gov/ct2/show/NCT03888456.",2020,"Consistent with a parasympathetic effect, analyses demonstrated a difference between OMT and sham groups on the nuHF ( p  < 0.001) and DFA-a1 ( p  < 0.01) as well as on skin conductance (<0.01).","['Thirty-seven participants (aged 27 ± 5 years old, male ratio 40%) completed the study', 'healthy adults', 'healthy non-symptomatic adults', 'Healthy Participants']","['Osteopathic manipulative treatment (OMT', 'Osteopathic Manipulative', 'two sessions (OMT and SHAM', 'OMT']","['Thermal images, HRV and skin conductance data', 'skin conductance', 'autonomic consequences']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",37.0,0.0458416,"Consistent with a parasympathetic effect, analyses demonstrated a difference between OMT and sham groups on the nuHF ( p  < 0.001) and DFA-a1 ( p  < 0.01) as well as on skin conductance (<0.01).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cerritelli', 'Affiliation': 'Clinical-based Human Research Department, Foundation COME Collaboration, Pescara, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cardone', 'Affiliation': ""Department of Neuroscience and Imaging, Institute for Advanced Biomedical Technologies, University G. D'Annunzio of Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Pirino', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Merla', 'Affiliation': ""Department of Neuroscience and Imaging, Institute for Advanced Biomedical Technologies, University G. D'Annunzio of Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Scoppa', 'Affiliation': 'Faculty of Medicine and Dental Surgery, Sapienza University of Rome, Rome, Italy.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00887']
2436,33013298,Does Unilateral Hearing Loss Impair Working Memory? An Italian Clinical Study Comparing Patients With and Without Hearing Aids.,"Working memory (WM) function can be reduced in patients suffering from unilateral hearing loss (UHL) and can affect their academic performance. We aimed to compare the WM abilities of three categories of children with UHL: patients implanted with hearing aids (HAs), patients receiving a bone-anchored hearing implant (BAHI), and subjects who did not receive hearing devices. A randomized clinical study, in which 45 children (mean age: 9.5 years) were evaluated by pure tone audiometry (to identify the side and the severity of the UHL), was conducted in a tertiary referral center. Patients were simply randomized into three groups: (1) children without HAs (No-HA group), (2) patients with a (digital) HA (HA group), and (3) children with a BAHI (BAHI group). Their working and short-term memories were studied in both noisy and silent conditions at the recruiting time (T0, baseline) and 6 months after (T1) the treatment. Statistical analyses were performed to analyze the variances between T0 and T1 within each group and between the three groups. The No-HA group improved its T1 WM scores in silence ( p  < 0.01), but not in noise. The HA and BAHI groups showed statistically significant variances of T1 WM in noise ( p  < 0.01 and  p  < 0.01, respectively). The HA and BAHI groups did not show statistically significant variances compared to T1. Our results suggest that hearing devices (HA and BAHI) in children with sensorineural UHL (SUHL) can improve WM capacity in noise. We speculate that bilateral hearing capacity might improve the quality of life of this population, especially during everyday activities where noise is present.",2020,"The HA and BAHI groups showed statistically significant variances of T1 WM in noise ( p  < 0.01 and  p  < 0.01, respectively).","['Patients With and Without Hearing Aids', '45 children (mean age: 9.5 years) were evaluated by pure tone audiometry (to identify the side and the severity of the UHL), was conducted in a tertiary referral center', 'Patients were simply randomized into three groups: (1) children without HAs (No-HA group), (2) patients with a (digital) HA (HA group), and (3) children with a BAHI (BAHI group', 'children with UHL: patients implanted with hearing aids (HAs), patients receiving a bone-anchored hearing implant (BAHI), and subjects who did not receive hearing devices', 'patients suffering from unilateral hearing loss (UHL', 'children with sensorineural UHL (SUHL']",['hearing devices (HA and BAHI'],"['T1 WM in noise', 'Working memory (WM) function', 'T1 WM scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521785', 'cui_str': 'Unilateral Hearing Loss'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0168442,"The HA and BAHI groups showed statistically significant variances of T1 WM in noise ( p  < 0.01 and  p  < 0.01, respectively).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Della Volpe', 'Affiliation': ""Otology and Cochlear Implant Unit, Department of Otolaryngology, Santobono-Pausilipon Children's Hospital, Naples, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ippolito', 'Affiliation': ""Otology and Cochlear Implant Unit, Department of Otolaryngology, Santobono-Pausilipon Children's Hospital, Naples, Italy.""}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Roccamatisi', 'Affiliation': 'Psychology Faculty, Università Telematica Internazionale Uninettuno, Rome, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Garofalo', 'Affiliation': ""Otology and Cochlear Implant Unit, Department of Otolaryngology, Santobono-Pausilipon Children's Hospital, Naples, Italy.""}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'De Lucia', 'Affiliation': ""Otology and Cochlear Implant Unit, Department of Otolaryngology, Santobono-Pausilipon Children's Hospital, Naples, Italy.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gambacorta', 'Affiliation': 'Department of Otolaryngology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Longari', 'Affiliation': 'Department of Otolaryngology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Ricci', 'Affiliation': 'Department of Otolaryngology, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Department of Otolaryngology, University of Perugia, Perugia, Italy.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00905']
2437,33013312,Resting-State Functional Connectivity Patterns Predict Acupuncture Treatment Response in Primary Dysmenorrhea.,"Primary dysmenorrhea (PDM) is a common complaint in women throughout the menstrual years. Acupuncture has been shown to be effective in dysmenorrhea; however, there are large interindividual differences in patients' responses to acupuncture treatment. Fifty-four patients with PDM were recruited and randomized into real or sham acupuncture treatment groups (over the course of three menstrual cycles). Pain-related functional connectivity (FC) matrices were constructed at baseline and post-treatment period. The different neural mechanisms altered by real and sham acupuncture were detected with multivariate analysis of variance. Multivariate pattern analysis (MVPA) based on a machine learning approach was used to explore whether the different FC patterns predicted the acupuncture treatment response in the PDM patients. The results showed that real but not sham acupuncture significantly relieved pain severity in PDM patients. Real and sham acupuncture displayed differences in FC alterations between the descending pain modulatory system (DPMS) and sensorimotor network (SMN), the salience network (SN) and SMN, and the SN and default mode network (DMN). Furthermore, MVPA found that these FC patterns at baseline could predict the acupuncture treatment response in PDM patients. The present study verified differentially altered brain mechanisms underlying real and sham acupuncture in PDM patients and supported the use of neuroimaging biomarkers for individual-based precise acupuncture treatment in patients with PDM.",2020,"Real and sham acupuncture displayed differences in FC alterations between the descending pain modulatory system (DPMS) and sensorimotor network (SMN), the salience network (SN) and SMN, and the SN and default mode network (DMN).","['Primary Dysmenorrhea', 'PDM patients', 'patients with PDM', 'Fifty-four patients with PDM']","['Acupuncture', 'sham acupuncture', 'acupuncture']","['Pain-related functional connectivity (FC) matrices', 'pain severity', 'Primary dysmenorrhea (PDM', 'FC alterations']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517807', 'cui_str': '54'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}]",54.0,0.244667,"Real and sham acupuncture displayed differences in FC alterations between the descending pain modulatory system (DPMS) and sensorimotor network (SMN), the salience network (SN) and SMN, and the SN and default mode network (DMN).","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Mingguo', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Fanrong', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Brain Research Center, Department of Acupuncture & Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.559191']
2438,33013359,Evaluating the Therapeutic Efficacy of Si-Wu-Tang Decoction and Concentrated Extract in Follicular Maldevelopment-Related Menstrual Disorders Through Pharmacokinetic/Pharmacodynamic Studies.,"Si-Wu-Tang (SWT), a traditional Chinese formula, is commonly used to relieve menstrual discomfort and climacteric syndrome. Water decoction (WD) and concentrated herbal extract (CHE) are the two most common formulations of traditional Chinese medicine (TCM). However, few studies have reported the equivalency of these two formulations. In this study, 23 healthy volunteers were included to determine the pharmacokinetic (PK) equivalent dosage of WD and CHE, and 25 infertile women with follicular maldevelopment to evaluate the pharmacodynamic (PD) effects on menstrual disorders. The randomized, two-way crossover comparative PK study of SWT-WD and SWT-CHE analyzed the active component, ferulic acid. The results showed that clinical doses of 170 mL SWT-WD and 18 g SWT-CHE produced the same amount of ferulic acid in the blood. The PD study showed that patients who took both of these formulations had an initial luteinizing hormone/follicle-stimulating hormone ratio of <1; however, the value returned to normal and their symptoms all improved after taken SWT. Our results showed that WD and CHE, both prepared from 40 g of SWT, displayed bioequivalence upon PK/PD analysis.",2020,"Our results showed that WD and CHE, both prepared from 40 g of SWT, displayed bioequivalence upon PK/PD analysis.","['25 infertile women with follicular maldevelopment to evaluate the pharmacodynamic (PD) effects on menstrual disorders', 'Follicular Maldevelopment-Related Menstrual Disorders', '23 healthy volunteers']","['Water decoction (WD) and concentrated herbal extract (CHE', 'Si-Wu-Tang Decoction and Concentrated Extract', 'Si-Wu-Tang (SWT', 'SWT-WD and SWT-CHE']",['initial luteinizing hormone/follicle-stimulating hormone ratio'],"[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025345', 'cui_str': 'Disorder of menstruation'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0911601', 'cui_str': 'si-wu-tang'}, {'cui': 'C1720005', 'cui_str': 'Concentrated extract'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",23.0,0.0949252,"Our results showed that WD and CHE, both prepared from 40 g of SWT, displayed bioequivalence upon PK/PD analysis.","[{'ForeName': 'Chia-Jung', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Alinafe Magret', 'Initials': 'AM', 'LastName': 'Kapelemera', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Zhe', 'Initials': 'YZ', 'LastName': 'Tsai', 'Affiliation': 'Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Tzu', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Traditional Chinese Medicine, Taipei Municipal Wanfang Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Xu', 'Affiliation': 'School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Chiung', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.01245']
2439,33013439,Kinetics of Physiological Responses as a Measure of Intensity and Hydration Status During Experimental Physical Stress in Human Volunteers.,"Introduction


Strenuous physical stress induces a range of physiological responses, the extent depending, among others, on the nature and severity of the exercise, a person's training level and overall physical resilience. This principle can also be used in an experimental set-up by measuring time-dependent changes in biomarkers for physiological processes. In a previous report, we described the effects of workload delivered on a bicycle ergometer on intestinal functionality. As a follow-up, we here describe an analysis of the kinetics of various other biomarkers.
Aim


To analyse the time-dependent changes of 34 markers for different metabolic and immunological processes, comparing four different exercise protocols and a rest protocol.
Methods


After determining individual maximum workloads, 15 healthy male participants (20-35 years) started with a rest protocol and subsequently performed (in a cross-over design with 1-week wash-out) four exercise protocols of 1-h duration at different intensities: 70% W  max  in a hydrated and a mildly dehydrated state, 50% W  max  and intermittent 85/55% W  max  in blocks of 2 min. Perceived exertion was monitored using the Borg' Rating of Perceived Exertion scale. Blood samples were collected both before and during exercise, and at various timepoints up to 24 h afterward. Data was analyzed using a multilevel mixed linear model with multiple test correction.
Results


Kinetic changes of various biomarkers were exercise-intensity-dependent. Biomarkers included parameters indicative of metabolic activity (e.g., creatinine, bicarbonate), immunological and hematological functionality (e.g., leukocytes, hemoglobin) and intestinal physiology (citrulline, intestinal fatty acid-binding protein, and zonulin). In general, responses to high intensity exercise of 70% W  max  and intermittent exercise i.e., 55/85% W  max  were more pronounced compared to exercise at 50% W  max  .
Conclusion


High (70 and 55/85% W  max  ) and moderate (50% W  max  ) intensity exercise in a bicycle ergometer test produce different time-dependent changes in a broad range of parameters indicative of metabolic activity, immunological and hematological functionality and intestinal physiology. These parameters may be considered biomarkers of homeostatic resilience. Mild dehydration intensifies these time-related changes. Moderate intensity exercise of 50% W  max  shows sufficient physiological and immunological responses and can be employed to test the health condition of less fit individuals.",2020,Moderate intensity exercise of 50% W  max  shows sufficient physiological and immunological responses and can be employed to test the health condition of less fit individuals.,"['Human Volunteers', '15 healthy male participants (20-35 years) started with a']","['rest protocol and subsequently performed (in a cross-over design with 1-week wash-out) four exercise protocols of 1-h duration at different intensities', 'intensity exercise', 'bicycle ergometer']","['Perceived exertion', 'metabolic activity (e.g., creatinine, bicarbonate), immunological and hematological functionality (e.g., leukocytes, hemoglobin) and intestinal physiology (citrulline, intestinal fatty acid-binding protein, and zonulin', 'Intensity and Hydration Status', 'metabolic activity, immunological and hematological functionality and intestinal physiology']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}]",15.0,0.0228359,Moderate intensity exercise of 50% W  max  shows sufficient physiological and immunological responses and can be employed to test the health condition of less fit individuals.,"[{'ForeName': 'Shirley W', 'Initials': 'SW', 'LastName': 'Kartaram', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Klaske', 'Initials': 'K', 'LastName': 'van Norren', 'Affiliation': 'Department of Nutritional Biology, Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schoen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Teunis', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutritional Biology, Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'Verschuren', 'Affiliation': 'Research Group Analysis Techniques in Life Sciences, Avans University of Applied Sciences, Breda, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""M'Rabet"", 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Isolde', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V., Amsterdam, Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mohrmann', 'Affiliation': 'Star-shl, Etten-Leur, Netherlands.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Wittink', 'Affiliation': 'Research Group Lifestyle and Health, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Garssen', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Renger', 'Initials': 'R', 'LastName': 'Witkamp', 'Affiliation': 'Department of Nutritional Biology, Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}]",Frontiers in physiology,['10.3389/fphys.2020.01006']
2440,33013446,Effects of Upper and Lower Limb Plyometric Training Program on Components of Physical Performance in Young Female Handball Players.,"Purpose


This study examined the effects of a 10-week combined upper and lower limb plyometric training (ULLPT) programs on components of physical performance in young female handball players.
Methods


Participants aged 15.8 ± 0.2 years were randomly assigned between the experimental (EG;  n  = 17) and control (CG;  n  = 17) groups. Two-way analyses of performance (group × time) assessed changes in handgrip force, back extensor strength; medicine ball throwing, 30-m sprint times, change of direction (CoD) [Modified Illinois test (Illinois-MT)], four jumping tests [squat jump (SJ), countermovement jump (CMJ), CMJ with arms (CMJA) and 5 jump test (5JT), static and dynamic balance, and repeated sprint T-test scores (RSTT)].
Results


After 10 weeks of plyometric training (two sessions per week), group × time interactions showed significant changes in EG relative to CG in right and left handgrip force, back extensor strength and medicine ball throwing [ p  < 0.001,  d  = 1.51 (large);  p  < 0.0001,  d  = 0.85 (large);  p  < 0.001,  d  = 0.90 (large);  p  < 0.0001,  d  = 0.52 (medium), respectively]. Group × time interactions also showed improvements of EG relative to CG in sprint times [5 m ( p  = 0.02,  d  = 0.80 (large)); 10 m ( p  < 0.0001,  d  = 1.00 (large)); 20 m ( p  = 0.02,  d  = 1.41 (large)); and 30 m ( p  = 0.02,  d  = 2.60 (large))], CoD [Illinois-MT ( p  < 0.001,  d  = 1.58 (large))] and jumping [(SJ, CMJ, CMJA, and 5JT,  p  = 0.001,  d  = 0.87 (large);  p  < 0.001,  d  = 1.17 (large);  p  < 0.001,  d  = 1.15 (large); and  p  = 0.006,  d  = 0.71 (medium)) respectively]. Further, all RSTT scores (best time, mean time, total time, and fatigue index) improved significantly in the experimental group, with group × time interactions varying between  p  < 0.001 and  p  = 0.049 ( d  value large to medium). However, balance did not differ significantly between EG and CG.
Conclusion


We conclude that 10 weeks of ULLPT improved many measures of physical performance in young female handball players.",2020,"Group × time interactions also showed improvements of EG relative to CG in sprint times [5 m ( p  = 0.02,  d  = 0.80 (large)); 10 m ( p  < 0.0001,  d  = 1.00 (large)); 20 m ( p  = 0.02,  d  = 1.41 (large)); and 30 m ( p  = 0.02,  d  = 2.60 (large))], CoD [Illinois-MT ( p  < 0.001,  d  = 1.58 (large))] and jumping [(SJ, CMJ, CMJA, and 5JT,  p  = 0.001,  d  = 0.87 (large);  p  < 0.001,  d  = 1.17 (large);  p  < 0.001,  d  = 1.15 (large); and  p  = 0.006,  d  = 0.71 (medium)) respectively].","['Methods\n\n\nParticipants aged 15.8 ± 0.2 years', 'Young Female Handball Players', 'young female handball players']","['Modified Illinois test (Illinois-MT', '10-week combined upper and lower limb plyometric training (ULLPT) programs', 'ULLPT', 'Upper and Lower Limb Plyometric Training Program', 'plyometric training']","['EG relative to CG in right and left handgrip force, back extensor strength and medicine ball throwing', 'Physical Performance', 'RSTT scores (best time, mean time, total time, and fatigue index', 'handgrip force, back extensor strength; medicine ball throwing, 30-m sprint times, change of direction (CoD', 'jumping tests [squat jump (SJ), countermovement jump (CMJ), CMJ with arms (CMJA) and 5 jump test (5JT), static and dynamic balance, and repeated sprint T-test scores (RSTT', 'physical performance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",,0.0182194,"Group × time interactions also showed improvements of EG relative to CG in sprint times [5 m ( p  = 0.02,  d  = 0.80 (large)); 10 m ( p  < 0.0001,  d  = 1.00 (large)); 20 m ( p  = 0.02,  d  = 1.41 (large)); and 30 m ( p  = 0.02,  d  = 2.60 (large))], CoD [Illinois-MT ( p  < 0.001,  d  = 1.58 (large))] and jumping [(SJ, CMJ, CMJA, and 5JT,  p  = 0.001,  d  = 0.87 (large);  p  < 0.001,  d  = 1.17 (large);  p  < 0.001,  d  = 1.15 (large); and  p  = 0.006,  d  = 0.71 (medium)) respectively].","[{'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saïd, Manouba University, Tunis, Tunisia.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Gaamouri', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saïd, Manouba University, Tunis, Tunisia.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saïd, Manouba University, Tunis, Tunisia.'}]",Frontiers in physiology,['10.3389/fphys.2020.01028']
2441,33013465,The Effect of Exogenous Ketone Monoester Ingestion on Plasma BDNF During an Oral Glucose Tolerance Test.,"Brain-derived neurotrophic factor (BDNF) is important for brain and metabolic function. Ingestion of a ketone monoester (KME) drink containing beta-hydroxybutyrate (β-OHB) attenuates hyperglycemia in humans and increases neuronal BDNF in rodents. Whether KME affects BDNF in humans is currently unknown. This study examined the effect of KME ingestion before an oral glucose tolerance test (OGTT) on plasma BDNF in normal-weight adults (NW) and adults with obesity (OB).  Methods : Exploratory, secondary analyses of two studies were performed. Study 1 included NW ( n  = 18; age = 25.3 ± 4.3 years; BMI = 22.2 ± 2.3 kg/m 2 ) and Study 2 included OB ( n  = 12; age = 48.8 ± 9.5 years; BMI = 33.7 ± 5.0 kg/m 2 ). Participants ingested 0.45 ml/kg -1  body weight KME or Placebo 30-min prior to completing a 75 g OGTT. β-OHB and BDNF were measured  via  blood samples at fasting baseline (pre-OGTT) and 120 min post-OGTT.  Results : Study 1: KME significantly increased β-OHB by 800 ± 454% ( p  < 0.001). BDNF significantly decreased post-OGTT compared to pre-OGTT in Placebo (718.6 ± 830.8 pg/ml vs. 389.3 ± 595.8 pg/ml;  p  = 0.018), whereas BDNF was unchanged in KME (560.2 ± 689.6 pg/ml vs. 469.2 ± 791.8 pg/ml;  p  = 0.28). Study 2: KME significantly increased β-OHB by 1,586 ± 602% ( p  < 0.001). BDNF was significantly higher post-OGTT in the KME condition in OB (time × condition interaction;  p  = 0.037). There was a moderate relationship between β-OHB and ∆ %BDNF (r = 0.616;  p  < 0.001). Fasting plasma BDNF was significantly lower in OB compared to NW (132.8 ± 142.8 pg/ml vs. 639.4 ± 756.8 pg/ml;  g  = 0.845;  p  = 0.002).  Conclusions : Plasma BDNF appears differentially impacted by KME ingestion with OGTT in OB compared to NW. Raising β-OHB  via  KME may be a strategy for increasing/protecting BDNF during hyperglycemia.",2020,Study 1: KME significantly increased β-OHB by 800 ± 454% ( p  < 0.001).,"['Study 1 included NW ( n  = 18; age = 25.3 ± 4.3 years; BMI = 22.2 ± 2.3 kg/m 2 ) and Study 2 included OB ( n  = 12; age = 48.8 ± 9.5 years; BMI = 33.7 ± 5.0 kg/m 2 ', 'normal-weight adults (NW) and adults with obesity (OB']","['KME', 'Exogenous Ketone Monoester Ingestion', 'oral glucose tolerance test (OGTT', 'ketone monoester (KME) drink containing beta-hydroxybutyrate (β-OHB', 'KME ingestion', 'Placebo', 'Brain-derived neurotrophic factor (BDNF']","['β-OHB', 'BDNF', 'β-OHB and BDNF', 'Plasma BDNF During an Oral Glucose Tolerance Test', 'Fasting plasma BDNF']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517899', 'cui_str': '9.5'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0036071', 'cui_str': 'salicylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]","[{'cui': 'C0036071', 'cui_str': 'salicylamide'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.112315,Study 1: KME significantly increased β-OHB by 800 ± 454% ( p  < 0.001).,"[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Walsh', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}]",Frontiers in physiology,['10.3389/fphys.2020.01094']
2442,33013469,Low Frequency Severe-Intensity Interval Training Markedly Alters Respiratory Compensation Point During Incremental Exercise in Untrained Male.,"This study investigated the effect of low-frequency severe-intensity interval training on the respiratory compensation point (RCP) during incremental exercise test. Eighteen healthy males (age; 20.7 ± 2.2 years, range 18 to 29 years, height; 174.0 ± 5.6 cm, weight; 68.8 ± 13.5 kg) were randomly assigned to an interval training group or a control group. Interval training was conducted once weekly for 3 months. Each session consisted of three bouts of bicycle ergometer exercise at 80% maximum work rate until volitional fatigue. Before (baseline) and after the 3-month intervention, incremental exercise test was performed on a bicycle ergometer for determination of ventilatory threshold (VT), RCP, and peak oxygen consumption (V̇ O   2  peak). The training program resulted in significant increases of V̇ O   2  peak (+ 14%,  p  < 0.001,  η   p   2    = 0.437), oxygen consumption (V̇ O   2 ) at VT (+ 18%,  p  < 0.001,  η   p   2    = 0.749) and RCP (+ 15%,  p  = 0.03,  η   p   2    = 0.239) during incremental exercise test in the training group. Furthermore, a significant positive correlation was observed between the increase in V̇ O   2  peak and increase in V̇ O   2  at RCP after intervention ( r  = 0.87,  p  = 0.002) in the training group. Tidal volumes at VT ( p  = 0.04,  η   p   2    = 0.270) and RCP ( p  = 0.01,  η   p   2    = 0.370) also increased significantly after intervention compared to baseline. Low-frequency severe-intensity interval training induced a shift in RCP toward higher work rate accompanied by higher tidal volume during incremental exercise test.",2020,"The training program resulted in significant increases of V̇ O   2  peak (+ 14%,  p  < 0.001,  η   p   2    = 0.437), oxygen consumption (V̇ O   2 ) at VT (+ 18%,  p  < 0.001,  η   p   2    = 0.749) and RCP (+ 15%,  p  = 0.03,  η   p   2    = 0.239) during incremental exercise test in the training group.","['Untrained Male', 'Eighteen healthy males (age; 20.7 ± 2.2 years, range 18 to 29 years, height; 174.0 ± 5.6 cm, weight; 68.8 ± 13.5 kg']","['bicycle ergometer exercise', 'low-frequency severe-intensity interval training', 'interval training group or a control group', 'incremental exercise test was performed on a bicycle ergometer for determination of ventilatory threshold (VT), RCP, and peak oxygen consumption (V̇ O   2  peak']","['V̇ O   2  peak', 'oxygen consumption', 'V̇ O   2  peak and increase in V̇ O', 'Tidal volumes']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517559', 'cui_str': '13.5'}]","[{'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",18.0,0.0402398,"The training program resulted in significant increases of V̇ O   2  peak (+ 14%,  p  < 0.001,  η   p   2    = 0.437), oxygen consumption (V̇ O   2 ) at VT (+ 18%,  p  < 0.001,  η   p   2    = 0.749) and RCP (+ 15%,  p  = 0.03,  η   p   2    = 0.239) during incremental exercise test in the training group.","[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Nakahara', 'Affiliation': 'Graduate School of Health Sciences, Morinomiya University of Medical Sciences, Osaka, Japan.'}, {'ForeName': 'Shin-Ya', 'Initials': 'SY', 'LastName': 'Ueda', 'Affiliation': 'Department of Physical Education, Faculty of Education, Gifu University, Gifu, Japan.'}, {'ForeName': 'Tadayoshi', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Graduate School of Human Environment, Faculty of Sport and Health Sciences, Osaka Sangyo University, Osaka, Japan.'}]",Frontiers in physiology,['10.3389/fphys.2020.01100']
2443,33013511,Shared Book-Reading in Early Childhood Education: Teachers' Mediation in Children's Communicative Development.,"Fostering communicative skills in young children is essential for their holistic development. Book-reading activities have been shown to be a valuable tool for supporting communicative exchanges between children and adults, but there is limited research on actual educational practices with children under 3 years old. This experimental study explores teaching practices in Chilean early childhood education with children from 4 to 17 months of age. We focused on children's performance of diverse communicative signs, as well as on the effect of the teacher's mediation (signs and strategies) in a triadic shared-reading interaction (teacher-child-book). The study is part of a larger cross-sectional project. We conducted an experimental study following a pre-test-post-test design with 11 children, who were randomly assigned to either the control or the experimental group. In addition, we conducted a 6-week intervention on shared book reading between the pre- and post-test stages. We observed that children used a wide range of communicative signs when engaging in shared interactions with their teacher and different books. In the experimental group, children performed more communicative signs after participating in the intervention than at the beginning of the study. The reading experience that they gained through the intervention could also explain the larger proportion of uses of the books, as compared to their control counterparts. Additionally, children performed different combinations of vocalizations, words, or repetitions within a single use. The conventional use of a book is not evident for an infant, and as such it requires the systematic and semiotically mediated action of an adult to be consolidated. We conclude that offering preschool teachers a diverse selection of books enables them to better adjust to the particularities of each child. In this scenario educators are able to promote efficient spaces for children's participation, increasing the complexity and variety of their communicative repertoire.",2020,We conclude that offering preschool teachers a diverse selection of books enables them to better adjust to the particularities of each child.,"['young children', '11 children', 'Chilean early childhood education with children from 4 to 17 months of age']",[],['communicative signs'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",11.0,0.0222337,We conclude that offering preschool teachers a diverse selection of books enables them to better adjust to the particularities of each child.,"[{'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Cárdenas', 'Affiliation': 'Departamento de Pedagogía en Educación Parvularia, Pontificia Universidad Católica de Chile, Campus Villarrica, Villarrica, Chile.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moreno-Núñez', 'Affiliation': 'Departamento de Psicología Evolutiva y de la Educación, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Miranda-Zapata', 'Affiliation': 'Laboratorio de Investigación en Ciencias Sociales Aplicadas, Universidad de La Frontera, Temuco, Chile.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02030']
2444,33013517,Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT.,"Introduction


To date, guidelines recommend the use of a stepped care approach to treat tinnitus. The current clinical management of tinnitus frequently consists of audiologic interventions and tinnitus retraining therapy (TRT) or cognitive behavioral therapy (CBT). Due to the high heterogeneity of the tinnitus population and comorbidity of tinnitus with insomnia, anxiety, and depression, these interventions may not be sufficient for every patient. The current study aims to determine whether a bimodal therapy for chronic, subjective tinnitus consisting of the combination of TRT and eye movement desensitization reprocessing (EMDR) results in a clinically significant different efficacy in comparison with the prevailing bimodal TRT and CBT therapy.
Methods


Patients were randomized in two treatment groups. The experimental group received the bimodal therapy TRT/EMDR and the active control group received the bimodal therapy TRT/CBT. Evaluations took place at baseline (T 0 ), at the end of the treatment (T 1 ), and 3 months after therapy (T 2 ). The tinnitus functional index (TFI) was used as primary outcome measurement. Secondary outcome measurements were the visual analog scale of tinnitus loudness (VAS Loudness ), tinnitus questionnaire (TQ), hospital anxiety and depression scale (HADS), hyperacusis questionnaire (HQ), global perceived effect (GPE), and psychoacoustic measurements.
Findings


The TFI showed clinically significant improvement in both bimodal therapies (mean decrease 15.1 in TRT/CBT;  p  < 0.001 vs. 16.2 in TRT/EMDR;  p  < 0.001). The total score on the TQ, HADS, HQ, and VAS Loudness  all demonstrated significant decrease after treatment and follow-up ( p  < 0.001) in the experimental and the active control group. GPE-measurements revealed that more than 80% (i.e., 84% in TRT/CBT vs. 80% in TRT/EMDR) of the patients experienced substantial improvement of tinnitus at follow up. Treatment outcome remained stable after 3 month follow-up and no adverse events were observed.
Conclusion


Both psychotherapeutic protocols result in a clinically significant improvement for patients with chronic subjective tinnitus. No significant different efficacy was found for the TRT/EMDR treatment compared to the combination of TRT and CBT.
Clinical Trial registration


ClinicalTrials.gov, ID: NCT03114878. April 14, 2017.",2020,"No significant different efficacy was found for the TRT/EMDR treatment compared to the combination of TRT and CBT.
","['Chronic Subjective Tinnitus', 'patients with chronic subjective tinnitus']","['bimodal therapy TRT/EMDR and the active control group received the bimodal therapy TRT/CBT', 'Bimodal Therapy', 'audiologic interventions and tinnitus retraining therapy (TRT) or cognitive behavioral therapy (CBT', 'EMDR and TRT Versus CBT and TRT', 'TRT and eye movement desensitization reprocessing (EMDR']","['efficacy', 'tinnitus functional index (TFI', 'adverse events', 'total score on the TQ, HADS, HQ, and VAS Loudness', 'GPE-measurements', 'visual analog scale of tinnitus loudness (VAS Loudness ), tinnitus questionnaire (TQ), hospital anxiety and depression scale (HADS), hyperacusis questionnaire (HQ), global perceived effect (GPE), and psychoacoustic measurements']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0155533', 'cui_str': 'Subjective tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0870535', 'cui_str': 'EMDR'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034880', 'cui_str': 'Hyperacusis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033877', 'cui_str': 'Psychoacoustics'}]",,0.0651226,"No significant different efficacy was found for the TRT/EMDR treatment compared to the combination of TRT and CBT.
","[{'ForeName': 'Tine Roanna', 'Initials': 'TR', 'LastName': 'Luyten', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Jacquemin', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Looveren', 'Affiliation': 'Hoorzorg Van Looveren BVBA, Borsbeek, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Declau', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fransen', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Cardon', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Bodt', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Topsakal', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van de Heyning', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Van Rompaey', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Gilles', 'Affiliation': 'Faculty of Medicine and Health Sciences, Department Translational Neuroscience, University of Antwerp, Antwerp, Belgium.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02048']
2445,33013550,HIIT the Road Jack: An Exploratory Study on the Effects of an Acute Bout of Cardiovascular High-Intensity Interval Training on Piano Learning.,"Pairing high-intensity interval training (HIIT) with motor skill acquisition may improve learning of some implicit motor sequences (albeit with some variability), but it is unclear if HIIT enhances  explicit  learning of motor sequences. We asked whether a single bout of HIIT after non-musicians learned to play a piano melody promoted better retention of the melody than low-intensity interval training (LIIT). Further, we investigated whether HIIT facilitated transfer of learning to a new melody. We generated individualized exercise protocols by having participants ( n  = 25) with little musical training undergo a graded maximal exercise test (GXT) to determine their cardiorespiratory fitness (VO 2   peak ) and maximum power output (W max ). In a subsequent session, participants practiced a piano melody (skill acquisition) and were randomly assigned to a single bout of HIIT or LIIT. Retention of the piano melody was tested 1 hour, 1 day, and 1 week after skill acquisition. We also evaluated transfer to learning a new melody 1 week after acquisition. Pitch and rhythm accuracy were analyzed with linear mixed-effects modeling. HIIT did not enhance sequence-specific retention of pitch or rhythmic elements of the piano melody, but there was modest evidence that HIIT facilitated transfer to learning a new melody. We tentatively conclude that HIIT enhances explicit, task-general motor consolidation.",2020,"HIIT did not enhance sequence-specific retention of pitch or rhythmic elements of the piano melody, but there was modest evidence that HIIT facilitated transfer to learning a new melody.",['having participants ( n  = 25) with'],"['piano melody (skill acquisition', 'single bout of HIIT or LIIT', 'Acute Bout of Cardiovascular High-Intensity Interval Training', 'low-intensity interval training (LIIT', 'HIIT the Road Jack', 'Pairing high-intensity interval training (HIIT) with motor skill acquisition', 'little musical training undergo a graded maximal exercise test (GXT']",['Pitch and rhythm accuracy'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",25.0,0.051089,"HIIT did not enhance sequence-specific retention of pitch or rhythmic elements of the piano melody, but there was modest evidence that HIIT facilitated transfer to learning a new melody.","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Swarbrick', 'Affiliation': 'Rehabilitation Sciences Institute, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Department of Research Design and Biostatistics, Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Trehub', 'Affiliation': 'Department of Psychology, University of Toronto Mississauga, Mississauga, ON, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tremblay', 'Affiliation': 'Centre for Motor Control, Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Alter', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Joyce L', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': 'Rehabilitation Sciences Institute, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02154']
2446,33013552,"Preschoolers Benefit Equally From Video Chat, Pseudo-Contingent Video, and Live Book Reading: Implications for Storytime During the Coronavirus Pandemic and Beyond.","During the unprecedented coronavirus disease (COVID-19) crisis, virtual education activities have become more prevalent than ever. One activity that many families have incorporated into their routines while at home is virtual storytime, with teachers, grandparents, and other remote adults reading books to children over video chat. The current study asks how dialogic reading over video chat compares to more traditional forms of book reading in promoting story comprehension and vocabulary learning. Fifty-eight 4-year-olds ( M   age  = 52.7,  SD  = 4.04, 31 girls) were randomly assigned to one of three conditions (Video chat, Live, and Prerecorded). Across conditions, children were read the same narrative storybook by a female experimenter who used the same 10 scripted dialogic reading prompts during book reading. In the  Video chat  ( n  = 21) and  Live conditions  ( n  = 18), the experimenter gave the scripted prompts and interacted naturally and  contingently , responding in a timely, relevant manner to children's behaviors. In the  Prerecorded condition  ( n  = 19), children viewed a video of an experimenter reading the book. The Prerecorded condition was  pseudo-contingent ; the reader posed questions and paused for a set period of time as if to wait for a child's response. After reading, children completed measures of vocabulary and comprehension. Results revealed no differences between conditions across six different outcome measures, suggesting that children comprehended and learned from the story similarly across book formats. Further, children in the three experimental conditions scored significantly higher on measures than children in a fourth condition (control) who had never read the book, confirming that children learned from the three different book formats. However, children were more responsive to the prompts in the  Live  and  Video chat  conditions than the  Prerecorded  condition, suggesting that children recognized that these interactions were contingent with their responses, a feature that was lacking in the  Prerecorded  condition. Results indicate that children can comprehend books over video chat, suggesting that this technology is a viable option for reading to children, especially during the current pandemic.",2020,"Results revealed no differences between conditions across six different outcome measures, suggesting that children comprehended and learned from the story similarly across book formats.","['Storytime', 'Fifty-eight 4-year-olds ( M   age  = 52.7,  SD  = 4.04, 31 girls']",[],['vocabulary and comprehension'],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.025808,"Results revealed no differences between conditions across six different outcome measures, suggesting that children comprehended and learned from the story similarly across book formats.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gaudreau', 'Affiliation': 'College of Education and Human Development, University of Delaware, Newark, DE, United States.'}, {'ForeName': 'Yemimah A', 'Initials': 'YA', 'LastName': 'King', 'Affiliation': 'Human Development and Family Studies, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Dore', 'Affiliation': 'College of Education and Human Ecology, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Puttre', 'Affiliation': 'Wheelock College of Education and Human Development, Boston University, Boston, MA, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Nichols', 'Affiliation': 'Human Development and Family Studies, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Hirsh-Pasek', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, United States.'}, {'ForeName': 'Roberta Michnick', 'Initials': 'RM', 'LastName': 'Golinkoff', 'Affiliation': 'College of Education and Human Development, University of Delaware, Newark, DE, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02158']
2447,33013558,Blue-Enriched White Light Improves Performance but Not Subjective Alertness and Circadian Adaptation During Three Consecutive Simulated Night Shifts.,"Use of blue-enriched light has received increasing interest regarding its activating and performance sustaining effects. However, studies assessing effects of such light during night work are few, and novel strategies for lighting using light emitting diode (LED) technology need to be researched. In a counterbalanced crossover design, we investigated the effects of a standard polychromatic blue-enriched white light (7000 K; ∼200 lx) compared to a warm white light (2500 K), of similar photon density (∼1.6 × 10 14  photons/cm 2 /s), during three consecutive simulated night shifts. A total of 30 healthy participants [10 males, mean age 23.3 ( SD  = 2.9) years] were included in the study. Dependent variables comprised subjective alertness using the Karolinska Sleepiness Scale, a psychomotor vigilance task (PVT) and a digit symbol substitution test (DSST), all administered at five time points throughout each night shift. We also assessed dim-light melatonin onset (DLMO) before and after the night shifts, as well as participants' opinion of the light conditions. Subjective alertness and performance on the PVT and DSST deteriorated during the night shifts, but 7000 K light was more beneficial for performance, mainly in terms of fewer errors on the PVT, at the end of the first- and second- night shift, compared to 2500 K light. Blue-enriched light only had a minor impact on PVT response times (RTs), as only the fastest 10% of the RTs were significantly improved in 7000 K compared to 2500 K light. In both 7000 and 2500 K light, the DLMO was delayed in those participants with valid assessment of this parameter [ n  = 20 (69.0%) in 7000 K light,  n  = 22 (78.6%) in 2500 K light], with a mean of 2:34 ( SE  = 0:14) and 2:12 ( SE  = 0:14) hours, respectively, which was not significantly different between the light conditions. Both light conditions were positively rated, although participants found 7000 K to be more suitable for work yet evaluated 2500 K light as more pleasant. The data indicate minor, but beneficial, effects of 7000 K light compared to 2500 K light on performance during night work. Circadian adaptation did not differ significantly between light conditions, though caution should be taken when interpreting these findings due to missing data. Field studies are needed to investigate similar light interventions in real-life settings, to develop recommendations regarding illumination for night workers.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier NCT03203538.",2020,"Subjective alertness and performance on the PVT and DSST deteriorated during the night shifts, but 7000 K light was more beneficial for performance, mainly in terms of fewer errors on the PVT, at the end of the first- and second- night shift, compared to 2500 K light.","['30 healthy participants [10 males, mean age 23.3 ( SD  = 2.9) years']","['Blue-Enriched White Light', 'standard polychromatic blue-enriched white light']","['Subjective Alertness and Circadian Adaptation', 'dim-light melatonin onset (DLMO', 'PVT response times (RTs', 'subjective alertness using the Karolinska Sleepiness Scale, a psychomotor vigilance task (PVT) and a digit symbol substitution test (DSST), all administered at five time points throughout each night shift', 'Subjective alertness and performance on the PVT and DSST deteriorated', 'DLMO', 'Circadian adaptation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",30.0,0.0195811,"Subjective alertness and performance on the PVT and DSST deteriorated during the night shifts, but 7000 K light was more beneficial for performance, mainly in terms of fewer errors on the PVT, at the end of the first- and second- night shift, compared to 2500 K light.","[{'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Sunde', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Torhild', 'Initials': 'T', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Mrdalj', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirunn', 'Initials': 'E', 'LastName': 'Thun', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Waage', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Skene', 'Affiliation': 'Chronobiology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02172']
2448,33013612,Feasibility of Music-Assisted Treadmill Training in Parkinson's Disease Patients With and Without Deep Brain Stimulation: Insights From an Ongoing Pilot Randomized Controlled Trial.,"Background:  Music-assisted treadmill training (MATT) is a new therapeutic approach for Parkinson's disease (PD) patients, combining treadmill training with rhythmic auditory cueing and visual feedback. PD studies have shown larger positive effects on motor outcomes than usual treadmill training. However, effects on cognition, in contrast, are less clear. Existing studies provided intensive training protocols and included only stable medicated patients. Thus, a pilot randomized controlled trial was designed to analyze the feasibility of a shorter training protocol as well as preliminary effects on cognition, motor function, and patient-centered outcomes in a rehabilitation setting where PD patients with and without deep brain stimulation (DBS) undergo adaptation of medication and DBS settings. Here, we present the results from the feasibility analysis of the still ongoing trial.  Methods:  Non-demented PD patients with and without DBS were recruited during their inpatient rehabilitation and randomized to an experimental group (EG; 20 min MATT) or an active control group (CG; 20 min bike ergometer training). The trainings took place for 8 consecutive days and were added to the usual rehabilitation. Feasibility was assessed with the following parameters: patients' study protocol acceptance, study protocol transferability into clinical routine, training-induced adverse events, and patients' training perception.  Results:  Thirty-two patients (EG:  n  = 15; CG:  n  = 17; 72% DBS) were included. The study protocol was well-accepted (inclusion rate: 84%). It was transferable into clinical routines; dropout rates of 40% (EG) and 18% (CG) were observed. However, an in-depth analysis of the dropout cohort did not reveal intervention-related dropout reasons. The MATT and the standard ergometer training showed no adverse events and were positively perceived by PD patients with and without DBS.  Conclusion:  MATT was shown to be a feasible, safe, and enjoyable treatment option in PD patients with and without DBS. Furthermore, the dropout cohort analysis revealed some exciting first insights into possible dropout reasons that go beyond the form of intervention. Therefore, research would benefit from a common practice of dropout analyses, as this would enhance our understanding of patients' therapy adherence and expectations.",2020,The MATT and the standard ergometer training showed no adverse events and were positively perceived by PD patients with and without DBS.  ,"[""Parkinson's Disease Patients With and Without Deep Brain Stimulation"", 'PD patients with and without deep brain stimulation (DBS) undergo adaptation of medication and DBS settings', 'demented PD patients with and without DBS', 'Results:  Thirty-two patients (EG:  n  = 15; CG:  n  = 17; 72% DBS) were included', 'PD patients with and without DBS', ""Parkinson's disease (PD) patients""]","['Music-Assisted Treadmill Training', 'Music-assisted treadmill training (MATT', 'treadmill training with rhythmic auditory cueing and visual feedback', 'active control group (CG; 20 min bike ergometer training', 'standard ergometer training']",['adverse events'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0621638,The MATT and the standard ergometer training showed no adverse events and were positively perceived by PD patients with and without DBS.  ,"[{'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Gooßes', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Saliger', 'Affiliation': 'Neurological Rehabilitation Center Godeshoehe, Bonn, Germany.'}, {'ForeName': 'Ann-Kristin', 'Initials': 'AK', 'LastName': 'Folkerts', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Nielsen', 'Affiliation': 'Neurological Rehabilitation Center Godeshoehe, Bonn, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Zierer', 'Affiliation': 'Neurological Rehabilitation Center Godeshoehe, Bonn, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Schmoll', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Niepold', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Colbach', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Leemhuis', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Engels', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'van Krüchten', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ophey', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Allert', 'Affiliation': 'Neurological Rehabilitation Center Godeshoehe, Bonn, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Karbe', 'Affiliation': 'Neurological Rehabilitation Center Godeshoehe, Bonn, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kalbe', 'Affiliation': 'Medical Psychology | Neuropsychology and Gender Studies, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",Frontiers in neurology,['10.3389/fneur.2020.00790']
2449,33013646,Cerebral Functional Manipulation of Repetitive Transcranial Magnetic Stimulation in Cognitive Impairment Patients After Stroke: An fMRI Study.,"Objective:  Recently, the area of repetitive transcranial magnetic stimulation (rTMS) targeting neurological rehabilitation has been advanced as a potential treatment for post-stroke cognitive impairment (PSCI). However, the underlying mechanisms remains to be elusived. This study aims to figure out cerebral functional manipulation of rTMS in patients with PSCI through using the resting-state functional magnetic resonance imaging (rs-fMRI).  Methods:  Thirty patients with PSCI were recruited and randomly allocated into two groups: the rTMS intervention group and control group. The rTMS intervention group was given 20 min of 5 Hz rTMS (or control) over left dorsolateral prefrontal cortex (DLPFC) besides routine cognitive intervention training for 3 consecutive weeks, five times per week, on weekdays. Cognition performance was assessed by the Minimum Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA). Neural activity and functional connectivity (FC) changes were acquired by rs-fMRI with fractional amplitude of low-frequency fluctuation (fALFF) and seed-based correlation analysis.  Results:  Cognition improvements were observed both in rTMS intervention group and control group ( P  < 0.01), while the rTMS group got more significant improvent than control group ( P  < 0.05). To be specified, compared with the control group, the rTMS group got higher fALFF values in these brain regions including superior temporal gyrus, inferior frontal gyrus and parahippocampal gyrus, while lower fALFF values in middle temporal gyrus, middle frontal gyrus and fusiform gyrus. In addition, the rTMS group showed increased FC between LDPFC and toprecuneus, inferior temporal gyrus, middle and inferior frontal gyrus and marginal gyrus, while decreased FC between LDPFC and middle temporal gyrus and thalamus.  Conclusion:  The increase and decrease of neural activity and FC in cognition-related regions detected by rs-fMRI are good indicators to clarify the underlining mechanisms of rTMS on PSCI.",2020,"To be specified, compared with the control group, the rTMS group got higher fALFF values in these brain regions including superior temporal gyrus, inferior frontal gyrus and parahippocampal gyrus, while lower fALFF values in middle temporal gyrus, middle frontal gyrus and fusiform gyrus.","['patients with PSCI through using the resting-state functional magnetic resonance imaging (rs-fMRI', 'Cognitive Impairment Patients', 'Thirty patients with PSCI']","['rTMS intervention group and control group', '5 Hz rTMS (or control) over left dorsolateral prefrontal cortex (DLPFC) besides routine cognitive intervention training', 'Repetitive Transcranial Magnetic Stimulation', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS) targeting neurological rehabilitation', 'rTMS']","['Minimum Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA', 'neural activity and FC', 'Cognition improvements', 'Cognition performance', 'fALFF values in middle temporal gyrus, middle frontal gyrus and fusiform gyrus', 'FC between LDPFC and toprecuneus, inferior temporal gyrus, middle and inferior frontal gyrus and marginal gyrus, while decreased FC between LDPFC and middle temporal gyrus and thalamus', 'Neural activity and functional connectivity (FC) changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}]","[{'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0186133,"To be specified, compared with the control group, the rTMS group got higher fALFF values in these brain regions including superior temporal gyrus, inferior frontal gyrus and parahippocampal gyrus, while lower fALFF values in middle temporal gyrus, middle frontal gyrus and fusiform gyrus.","[{'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Department of Rehabilitation Medicine, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""Department of Rehabilitation Medicine, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Longlin', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': ""Department of Radiology, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Kuide', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': ""Department of Rehabilitation Medicine, School of Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}]",Frontiers in neurology,['10.3389/fneur.2020.00977']
2450,33013662,Sudden Caffeine Withdrawal Triggers Migraine-A Randomized Controlled Trial.,"Objective:  Assessing the effects of caffeine withdrawal on migraine.  Background:  The effects of caffeine withdrawal on migraineurs are at large unknown.  Methods:  This was a randomized, double-blind, crossover study (NCT03022838), designed to enroll 80 adults with episodic migraine and a daily consumption of 300-800 mg caffeine. Participants substituted their estimated dietary caffeine with either placebo capsules or capsulated caffeine tablets for 5 weeks before switching the comparators for 5 more weeks.  Results:  The study was terminated due to low recruitment. Ten subjects with a mean age of 46.3 ± 9.9 years, BMI of 24.9 ± 3.7, and a mean blood pressure of 134/83 ± 17/12 mmHg were enrolled. The average consumption of caffeine per day was 539 ± 196.3 mg. The average monthly headache days and migraine attack frequency at baseline was 11.5 ± 4.9 and 5.2 ± 1.2, respectively. At baseline Pittsburgh Sleep Quality Index was 5.8 ± 2.5 and HIT-6 was 62.8 ± 3.9. There were no differences in these or in parameters from actigraphy during the caffeine period compared with the placebo period. One subject withdrew just after entering the study. In the remaining nine, withdrawal triggered severe migraine attacks in seven, causing one more drop-out, and a typical caffeine withdrawal syndrome in two. Caffeine continuation did not trigger migraines, but one attack occurred in the wake of caffeine reintroduction.  Conclusions:  The study failed to answer how caffeine withdrawal affects migraineurs over time, but showed that abrupt withdrawal of caffeine is a potent trigger for migraine attacks.",2020,There were no differences in these or in parameters from actigraphy during the caffeine period compared with the placebo period.,"['Ten subjects with a mean age of 46.3 ± 9.9 years, BMI of 24.9 ± 3.7, and a mean blood pressure of 134/83 ± 17/12 mmHg were enrolled', '80 adults with episodic migraine and a daily consumption of 300-800 mg']","['placebo capsules or capsulated caffeine tablets', 'caffeine', 'Caffeine']","['withdrawal triggered severe migraine attacks', 'average monthly headache days and migraine attack frequency']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1245218', 'cui_str': 'Caffeine Oral Tablet'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",10.0,0.108971,There were no differences in these or in parameters from actigraphy during the caffeine period compared with the placebo period.,"[{'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Alstadhaug', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Hilde Karen', 'Initials': 'HK', 'LastName': 'Ofte', 'Affiliation': 'Nordland Hospital Trust, Bodø, Norway.'}, {'ForeName': 'Kai Ivar', 'Initials': 'KI', 'LastName': 'Müller', 'Affiliation': 'Institute of Clinical Medicine, The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Andreou', 'Affiliation': ""Headache Research, Wolfson CARD, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}]",Frontiers in neurology,['10.3389/fneur.2020.01002']
2451,33013668,Emotional Regulation Following Acquired Brain Injury: Associations With Executive Functioning in Daily Life and Symptoms of Anxiety and Depression.,"Objective:  To examine whether a questionnaire measuring emotional regulation after acquired brain injury adds clinical information beyond what can be obtained with a comprehensive executive function questionnaire and an anxiety and depression measure.  Method:  Seventy adult persons (age 19-66 years,  M   age  = 43,  SD   age  = 13) with acquired brain injury in the chronic phase and executive function complaints. All were recruited to participate in a randomized controlled trial (NCT02692352) evaluating the effects of cognitive rehabilitation. Traumatic brain injury was the dominant cause of injury (64%), and mean time since injury was 8 years. Emotional regulation was assessed with the Brain Injury Trust Regulation of Emotions Questionnaire (BREQ). Executive function was assessed with the Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A). The Hopkins Symptom Checklist 25 (HCSL-25) was employed to measure anxiety and depression symptoms.  Results:  Overall, significant correlations were found between reports of emotional regulation (BREQ) and executive function in daily life (BRIEF-A). Furthermore, our analyses revealed a significant relationship between self-reported scores of emotional regulation (BREQ) and symptoms of anxiety and depression (HSCL-25).  Conclusion:  The significant associations between the BREQ and most of the other clinical measures indicate that, for patients with acquired brain injury, the BREQ does not add substantial information beyond what can be assessed with the BRIEF-A and the HSCL-25.",2020,"Overall, significant correlations were found between reports of emotional regulation (BREQ) and executive function in daily life (BRIEF-A).","['Acquired Brain Injury', 'Seventy adult persons (age 19-66 years,  M   age  = 43,  SD   age  = 13) with acquired brain injury in the chronic phase and executive function complaints']",['cognitive rehabilitation'],"['Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A', 'Executive function', 'emotional regulation (BREQ) and symptoms of anxiety and depression (HSCL-25', 'emotional regulation (BREQ) and executive function in daily life (BRIEF-A', 'Emotional Regulation', 'anxiety and depression symptoms', 'Emotional regulation', 'Brain Injury Trust Regulation of Emotions Questionnaire (BREQ', 'Daily Life and Symptoms of Anxiety and Depression']","[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",70.0,0.0461102,"Overall, significant correlations were found between reports of emotional regulation (BREQ) and executive function in daily life (BRIEF-A).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stubberud', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Løvstad', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Kristin', 'Initials': 'AK', 'LastName': 'Solbakk', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Kristine', 'Initials': 'AK', 'LastName': 'Schanke', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Tornås', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}]",Frontiers in neurology,['10.3389/fneur.2020.01011']
2452,33013705,Individual Response Variation in the Effects of Weight Loss and Exercise on Insulin Sensitivity and Cardiometabolic Risk in Older Adults.,"Weight loss induced by decreased energy intake (diet) or exercise generally has favorable effects on insulin sensitivity and cardiometabolic risk. The variation in these responses to diet-induced weight loss with or without exercise, particularly in older obese adults, is less clear. The objectives of our study were to (1) examine the effect of weight loss with or without exercise on the variability of responses in insulin sensitivity and cardiometabolic risk factors and (2) to explore whether baseline phenotypic characteristics are associated with response. Sedentary older obese (BMI 36.3 ± 5.0 kg/m 2 ) adults (68.6 ± 4.7 years) were randomized to one of 3 groups: health education control (HED); diet-induced weight loss (WL); or weight loss and exercise (WL + EX) for 6 months. Composite Z-scores were calculated for changes in insulin sensitivity (C_IS: rate of glucose disposal/insulin at steady state during hyperinsulinemic euglycemic clamp, HOMA-IR, and HbA1C) and cardiometabolic risk (C_CMR: waist circumference, triglycerides, and fasting glucose). Baseline measures included body composition (MRI), cardiorespiratory fitness,  in vivo  mitochondrial function (ATPmax; P-MRS), and muscle fiber type. WL + EX groups had a greater proportion of High Responders in both C_IS and C_CMR compared to HED and WL only (all  p  < 0.05). Pre-intervention measures of insulin ( r  = 0.60) and HOMA-IR ( r  = 0.56) were associated with change in insulin sensitivity (C_IS) in the WL group ( p  < 0.05). Pre-intervention measures of glucose ( r  = 0.55), triglycerides ( r  = 0.53), and VLDL ( r  = 0.53) were associated with change in cardiometabolic risk (C_CMR) in the WL group ( p  < 0.05), whereas triglycerides ( r  = 0.59) and VLDL ( r  = 0.59) were associated with C_CMR (all  p  < 0.05) in WL + EX. Thus, the addition of exercise to diet-induced weight loss increases the proportion of older obese adults who improve insulin sensitivity and cardiometabolic risk. Additionally, individuals with poorer metabolic status are more likely to experience greater improvements in cardiometabolic risk during weight loss with or without exercise.",2020,WL + EX groups had a greater proportion of High Responders in both C_IS and C_CMR compared to HED and WL only (all  p  < 0.05).,"['older obese adults', 'Sedentary older obese (BMI 36.3 ± 5.0 kg/m 2 ) adults (68.6 ± 4.7 years', 'Older Adults']","['health education control (HED); diet-induced weight loss (WL); or weight loss and exercise (WL + EX', 'WL + EX', 'Weight Loss and Exercise']","['cardiometabolic risk (C_CMR', 'insulin sensitivity (C_IS: rate of glucose disposal/insulin at steady state during hyperinsulinemic euglycemic clamp, HOMA-IR, and HbA1C) and cardiometabolic risk (C_CMR: waist circumference, triglycerides, and fasting glucose', 'C_CMR', 'HOMA-IR', 'Insulin Sensitivity and Cardiometabolic Risk', 'cardiometabolic risk', 'insulin sensitivity (C_IS', 'body composition (MRI), cardiorespiratory fitness,  in vivo  mitochondrial function (ATPmax; P-MRS), and muscle fiber type', 'Composite Z-scores', 'insulin sensitivity and cardiometabolic risk', 'triglycerides', 'VLDL', 'Weight loss']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0227861,WL + EX groups had a greater proportion of High Responders in both C_IS and C_CMR compared to HED and WL only (all  p  < 0.05).,"[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Brennan', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Standley', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}, {'ForeName': 'Fanchao', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}, {'ForeName': 'Elvis A', 'Initials': 'EA', 'LastName': 'Carnero', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Sparks', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}, {'ForeName': 'Bret H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': 'Translational Research Institute, AdventHealth Research Institute, Orlando, FL, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00632']
2453,33013713,Corrigendum: Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Jinlida Granules on Metabolic Syndrome in Patients With Abnormal Glucose Metabolism.,[This corrects the article DOI: 10.3389/fendo.2020.00415.].,2020,[This corrects the article DOI: 10.3389/fendo.2020.00415.].,['Patients With Abnormal Glucose Metabolism'],['Jinlida Granules'],['Metabolic Syndrome'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580546', 'cui_str': 'Blood glucose abnormal'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]","[{'cui': 'C4079029', 'cui_str': 'jinlida'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",,0.0567925,[This corrects the article DOI: 10.3389/fendo.2020.00415.].,"[{'ForeName': 'De', 'Initials': '', 'LastName': 'Jin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Shuolong', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiovascularology, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Huailin', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiovascularology, Key Disciplines of State Administration of TCM for Collateral Disease, Shijiazhuang, China.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, Heibei Yiling Hospital, Shijiazhuang, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Piao', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Shenzhen Hospital, Guangzhou University of Chinese Medicine, Shenzhen, China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xiao-Lin', 'Affiliation': ""Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.""}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00649']
2454,33013880,"The Immunologic Effect of Early Intravenous Two and Four Gram Bolus Dosing of Tranexamic Acid Compared to Placebo in Patients With Severe Traumatic Bleeding (TAMPITI): A Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial.","Background


The hemostatic properties of tranexamic acid (TXA) are well described, but the immunological effects of TXA administration after traumatic injury have not been thoroughly examined. We hypothesized TXA would reduce monocyte activation in bleeding trauma patients with severe injury.
Methods


This was a single center, double-blinded, randomized controlled trial (RCT) comparing placebo to a 2 g or 4 g intravenous TXA bolus dose in trauma patients with severe injury. Fifty patients were randomized into each study group. The primary outcome was a reduction in monocyte activation as measured by human leukocyte antigen-DR isotype (HLA-DR) expression on monocytes 72 h after TXA administration. Secondary outcomes included kinetic assessment of immune and hemostatic phenotypes within the 72 h window post-TXA administration.
Results


The trial occurred between March 2016 and September 2017, when data collection ended. 149 patients were analyzed (placebo,  n  = 50; 2 g TXA,  n  = 49; 4 g TXA,  n  = 50). The fold change in HLA-DR expression on monocytes [reported as median (Q1-Q3)] from pre-TXA to 72 h post-TXA was similar between placebo [0.61 (0.51-0.82)], 2 g TXA [0.57 (0.47-0.75)], and 4 g TXA [0.57 (0.44-0.89)] study groups ( p  = 0.82). Neutrophil CD62L expression was reduced in the 4 g TXA group [fold change: 0.73 (0.63-0.97)] compared to the placebo group [0.97 (0.78-1.10)] at 24 h post-TXA ( p  = 0.034). The fold decrease in plasma IL-6 was significantly less in the 4 g TXA group [1.36 (0.87-2.42)] compared to the placebo group [0.46 (0.19-1.69)] at 72 h post-TXA ( p  = 0.028). There were no differences in frequencies of myeloid or lymphoid populations or in classical complement activation at any of the study time points.
Conclusion


In trauma patients with severe injury, 4 g intravenous bolus dosing of TXA has minimal immunomodulatory effects with respect to leukocyte phenotypes and circulating cytokine levels.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier NCT02535949.",2020,"There were no differences in frequencies of myeloid or lymphoid populations or in classical complement activation at any of the study time points.
","['trauma patients with severe injury', 'Patients With Severe Traumatic Bleeding (TAMPITI', 'bleeding trauma patients with severe injury', '149 patients were', 'Fifty patients']","['analyzed (placebo', 'Tranexamic Acid', 'tranexamic acid (TXA', 'placebo', 'Placebo', 'TXA']","['plasma IL-6', 'kinetic assessment of immune and hemostatic phenotypes within the 72 h window post-TXA administration', 'Neutrophil CD62L expression', 'human leukocyte antigen-DR isotype (HLA-DR) expression on monocytes 72 h', 'HLA-DR expression on monocytes', 'reduction in monocyte activation', 'monocyte activation']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040797', 'cui_str': 'Traumatic hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C5191071', 'cui_str': '149'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",149.0,0.712007,"There were no differences in frequencies of myeloid or lymphoid populations or in classical complement activation at any of the study time points.
","[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Thomas', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Isaiah R', 'Initials': 'IR', 'LastName': 'Turnbull', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Fuchs', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bochicchio', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schuerer', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Reese', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Adrian A', 'Initials': 'AA', 'LastName': 'Coleoglou Centeno', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Horn', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baty', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Shea', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'M Adam', 'Initials': 'MA', 'LastName': 'Meledeo', 'Affiliation': 'United States Army Institute of Surgical Research, Joint Base San Antonio-Fort Sam Houston, San Antonio, TX, United States.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'United States Army Institute of Surgical Research, Joint Base San Antonio-Fort Sam Houston, San Antonio, TX, United States.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Department of Anesthesiology and Critical Care, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Cap', 'Affiliation': 'United States Army Institute of Surgical Research, Joint Base San Antonio-Fort Sam Houston, San Antonio, TX, United States.'}, {'ForeName': 'Grant V', 'Initials': 'GV', 'LastName': 'Bochicchio', 'Affiliation': 'Section of Acute and Critical Care Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in immunology,['10.3389/fimmu.2020.02085']
2455,33014019,Prediction of Radiosensitivity in Head and Neck Squamous Cell Carcinoma Based on Multiple Omics Data.,"Head and neck squamous cell carcinoma (HNSCC) is a malignant tumor. Radiotherapy (RT) is an important treatment for HNSCC, but not all patients derive survival benefit from RT due to the individual differences on radiosensitivity. A prediction model of radiosensitivity based on multiple omics data might solve this problem. Compared with single omics data, multiple omics data can illuminate more systematical associations between complex molecular characteristics and cancer phenotypes. In this study, we obtained 122 differential expression genes by analyzing the gene expression data of HNSCC patients with RT ( N  = 287) and without RT ( N  = 189) downloaded from The Cancer Genome Atlas. Then, HNSCC patients with RT were randomly divided into a training set ( N  = 149) and a test set ( N  = 138). Finally, we combined multiple omics data of 122 differential genes with clinical outcomes on the training set to establish a 12-gene signature by two-stage regularization and multivariable Cox regression models. Using the median score of the 12-gene signature on the training set as the cutoff value, the patients were divided into the high- and low-score groups. The analysis revealed that patients in the low-score group had higher radiosensitivity and would benefit from RT. Furthermore, we developed a nomogram to predict the overall survival of HNSCC patients with RT. We compared the prognostic value of 12-gene signature with those of the gene signatures based on single omics data. It suggested that the 12-gene signature based on multiple omics data achieved the best ability for predicting radiosensitivity. In conclusion, the proposed 12-gene signature is a promising biomarker for estimating the RT options in HNSCC patients.",2020,"In conclusion, the proposed 12-gene signature is a promising biomarker for estimating the RT options in HNSCC patients.","['Head and neck squamous cell carcinoma (HNSCC', 'HNSCC patients with RT ( N  = 287) and without RT ( N  = 189) downloaded from The Cancer Genome Atlas', 'HNSCC patients with RT', 'HNSCC patients', 'Head and Neck Squamous Cell Carcinoma']",['Radiotherapy (RT'],"['overall survival', 'higher radiosensitivity']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034537', 'cui_str': 'Tolerance, Radiation'}]",,0.0175576,"In conclusion, the proposed 12-gene signature is a promising biomarker for estimating the RT options in HNSCC patients.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Anhui Provincial Engineering Laboratory of Beidou Precision Agricultural Information, Anhui Agricultural University, Hefei, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}, {'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Wen', 'Affiliation': 'Key Laboratory of High Magnetic Field and Ion Beam Physical Biology, Hefei Institutes of Physical Science, Chinese Academy of Sciences, Hefei, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of High Magnetic Field and Ion Beam Physical Biology, Hefei Institutes of Physical Science, Chinese Academy of Sciences, Hefei, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Bin', 'Affiliation': 'Key Laboratory of Intelligent Computing and Signal Processing of Ministry of Education, Institutes of Physical Science and Information Technology, Anhui University, Hefei, China.'}]",Frontiers in genetics,['10.3389/fgene.2020.00960']
2456,33014039,Effect of Combined Live Probiotics Alleviating the Gastrointestinal Symptoms of Functional Bowel Disorders.,"Objective


Changes of the gut microbiota are related to the pathogenesis of functional bowel disorders (FBDs), and probiotic supplementation may be an effective treatment option. Therefore, we aimed to investigate the effect of combined live probiotics on the gastrointestinal symptoms of FBDs via altering the gut microbiota.
Methods


Patients with the gastrointestinal symptoms of FBDs attending the Outpatient Department, from July to November 2019, were recruited. After the bowel preparation with polyethylene glycol electrolyte powder and colonoscopy, patients with normal result of colonoscopy were randomly divided into the probiotics group and control group. Patients in the probiotics group were prescribed with combined live  Bacillus subtilis  and  Enterococcus faecium  enteric-coated capsules for 4 weeks. Small intestinal bacteria overgrowth (SIBO) was measured by lactulose hydrogen breath test, and the microbial DNA was extracted from the fecal samples and the bacteria were classified by 16S rDNA gene amplicon sequencing.
Results


Twenty-five patients of each group were recruited, and there was no significant difference between the probiotics and control groups on baseline gastrointestinal symptom rating scale (GSRS), positive rate of SIBO, and relative abundances of the gut microbiota at the phylum level. After 4 weeks of treatment, the values of the probiotics and control groups were as follows: GSRS 1.4 ± 1.4 and 3.6 ± 1.6 and positive rate of SIBO 28.0% and 56.0%, respectively. The median relative abundances of the gut microbiota were 1.01% and 5.03% Actinobacteria and 43.80% and 35.17% Bacteroidetes at the phylum level; 0.76% and 3.29%  Bifidobacterium , 0.13% and 0.89%  Cillinsella , 0.03% and 0.01%  Enterococcus , 0.18% and 0.36%  Lachnospiraceae , 0.10% and 0.16%  Ruminococcus torques group , 1.31% and 2.44%  Blautia , and 0.83% and 2.02%  Fusicatenibacter  at the genus level ( P  < 0.05), respectively.
Conclusion


Combined live probiotic supplementation after the bowel preparation can alter the gut microbiota, decontaminate SIBO, and alleviate the gastrointestinal symptoms of FBDs. This trial is registered with ChiCTR1900026472.",2020,"Fusicatenibacter  at the genus level ( P  < 0.05), respectively.
","['Methods\n\n\nPatients with the gastrointestinal symptoms of FBDs attending the Outpatient Department, from July to November 2019, were recruited', 'patients with normal result of colonoscopy']","['combined live  Bacillus subtilis  and  Enterococcus faecium  enteric-coated capsules for 4 weeks', 'Combined Live Probiotics', 'probiotics group and control group', 'polyethylene glycol electrolyte powder and colonoscopy', 'live probiotic supplementation', 'combined live probiotics']","['median relative abundances of the gut microbiota', 'gastrointestinal symptoms of FBDs via altering the gut microbiota', 'gut microbiota, decontaminate SIBO', 'Gastrointestinal Symptoms of Functional Bowel Disorders', 'Small intestinal bacteria overgrowth (SIBO', 'baseline gastrointestinal symptom rating scale (GSRS), positive rate of SIBO, and relative abundances of the gut microbiota at the phylum level']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0016807', 'cui_str': 'Functional disorder of intestine'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0459422', 'cui_str': 'Normal result'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}, {'cui': 'C0991569', 'cui_str': 'Delayed Release Oral Capsule'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0016807', 'cui_str': 'Functional disorder of intestine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C2959722', 'cui_str': 'Small bowel bacterial overgrowth syndrome'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0520528,"Fusicatenibacter  at the genus level ( P  < 0.05), respectively.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Digestive Department, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Digestive Department, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Digestive Department, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.'}]",Gastroenterology research and practice,['10.1155/2020/4181748']
2457,33014060,Resistance to Cyclic Fatigue of Nickel-Titanium Files Immersed in Sodium Hypochlorite at Body Temperature.,"Materials and Methods


Forty-five files from each brand were randomly assigned to three groups ( n  = 15) and subjected to the following: no immersion (control), 1-minute immersion, and 5-minute immersion in 2.5% NaOCl at 37°C. CF for all the files was tested within a well-lubricated stainless-steel artificial canal in a water bath at 37°C simulating body temperature. The procedure was video recorded, and the number of cycles to fracture (NCF) was calculated by multiplying the time taken to fracture, with the number of rotations per second. The data were analyzed for normality, and thereafter, one-way ANOVA with multiple Bonferroni was used as the post hoc test.
Results


The resistance to CF of OC files was significantly higher than PTG files in all groups. In groups immersed in NaOCl for one minute, OC files showed significant drop in the CF resistance; PTG files showed a drop as well but not significantly. Both files demonstrated a significant drop in resistance to CF after immersion in NaOCl for five minutes compared to the control group.
Conclusion


OC files were significantly more resistant to CF compared to PTG in all groups. Immersion in 2.5% NaOCl for 5 minutes significantly reduced the resistance to CF for all the files.",2020,"Both files demonstrated a significant drop in resistance to CF after immersion in NaOCl for five minutes compared to the control group.
",[],"['no immersion (control), 1-minute immersion, and 5-minute immersion in 2.5% NaOCl']","['resistance to CF', 'number of cycles to fracture (NCF', 'CF resistance; PTG files', 'resistance to CF of OC files']",[],"[{'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0016094', 'cui_str': 'Filing'}]",45.0,0.0164723,"Both files demonstrated a significant drop in resistance to CF after immersion in NaOCl for five minutes compared to the control group.
","[{'ForeName': 'Hind F', 'Initials': 'HF', 'LastName': 'Abuhulaibah', 'Affiliation': 'Restorative Dentistry Department, Endodontics Division, Riyadh Elm University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'AbuMostafa', 'Affiliation': 'Restorative Dentistry Department, Endodontics Division, Riyadh Elm University, Riyadh, Saudi Arabia.'}]",International journal of dentistry,['10.1155/2020/8830163']
2458,33014084,The use of multimodal low-opioid anesthesia for coronary artery bypass grafting surgery in conditions of artificial blood circulation.,"Introduction


Cardiovascular diseases (CVD) are the main cause of death worldwide, and according to experts, they will continue to dominate the structure of global mortality.
Aim


The effectiveness of the multimodal low-opioid anesthesia technique in performing coronary artery bypass graft operations with artificial blood circulation.
Material and methods


Ninety-six patients aged 61.8 ±10.4 years underwent coronary artery bypass grafting under artificial blood circulation. Group I: propofol, sevoflurane, fentanyl, pipecuronium bromide (standard doses). Group II: dexketoprofen trometamol (50 mg), intravenous lidocaine (1% - 1 mg/kg bolus) and continuous lidocaine infusion (1.5-2 mg/kg/h), propofol, ketamine (0.5 mg/kg), magnesia sulfate, minimal doses of fentanyl.
Results


Average duration of anesthesia - 257.4 ±19.1 min; assisted blood circulation - 55 ±10 min. Mean dose of fentanyl in group I - 4.66 ±1.58 µg/kg/h, in group II - 1.29 ±0.32 µg/kg/h.Standard lab values and stress hormonal changes were within the normal range (mean cortisol: 479.3 ±26.4 nmol/l, lactate 1.61 ±0.2 mmol/l, glucose 6.42 ±0.9 mmol/l). Changes in heart rate within group I had a significant amplitude of dynamics, while in group II, these values were relatively at the same level throughout the entire anesthetic provision. Mean arterial pressure changes in group I were characterized by a significant reduction at the stage of induction, support and sternum reduction, whereas in group II it was relatively at the same level during the entire anesthetic management and significantly differed from baseline only at the stage of induction.
Conclusions


Multimodal low-opioid anesthesia during coronary artery bypass surgery with artificial blood circulation allows one to ensure adequate analgesia and avoid the intraoperative usage of routine doses of fentanyl, as indicated by the absence of hemodynamic and endocrine-metabolic changes.",2020,"Mean arterial pressure changes in group I were characterized by a significant reduction at the stage of induction, support and sternum reduction, whereas in group II it was relatively at the same level during the entire anesthetic management and significantly differed from baseline only at the stage of induction.
","['coronary artery bypass grafting surgery in conditions of artificial blood circulation', 'Material and methods\n\n\nNinety-six patients aged 61.8 ±10.4 years underwent']","['continuous lidocaine infusion', 'multimodal low-opioid anesthesia technique', 'magnesia sulfate, minimal doses of fentanyl', 'fentanyl', 'multimodal low-opioid anesthesia', 'Multimodal low-opioid anesthesia', 'coronary artery bypass grafting under artificial blood circulation', 'propofol, ketamine', 'dexketoprofen trometamol', 'intravenous lidocaine', 'propofol, sevoflurane, fentanyl, pipecuronium bromide']","['Standard lab values and stress hormonal changes', 'heart rate', 'Mean arterial pressure changes']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005836', 'cui_str': 'Blood, Artificial'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0005836', 'cui_str': 'Blood, Artificial'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0765538', 'cui_str': 'Dexketoprofen tromethamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0206049', 'cui_str': 'pipecuronium bromide'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",96.0,0.0223376,"Mean arterial pressure changes in group I were characterized by a significant reduction at the stage of induction, support and sternum reduction, whereas in group II it was relatively at the same level during the entire anesthetic management and significantly differed from baseline only at the stage of induction.
","[{'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Loskutov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine.'}, {'ForeName': 'Taisiia', 'Initials': 'T', 'LastName': 'Danchyna', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine.'}, {'ForeName': 'Dmitryi', 'Initials': 'D', 'LastName': 'Dzuba', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Druzina', 'Affiliation': 'Department of Anaesthesiology and Perfusiology, SE ""Heart Institute"" of MOH, Kyiv, Ukraine.'}]",Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery,['10.5114/kitp.2020.99072']
2459,33014110,"Effect of Moxibustion on the Serum Levels of MMP-1, MMP-3, and VEGF in Patients with Rheumatoid Arthritis.","Background


Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease, which will eventually lead to joints deformity and functional damage. The aim of this research is to evaluate the effect of moxibustion on the serum indicators related to bone and cartilage metabolism, matrix metalloproteinase 1 (MMP-1), matrix metalloproteinase 3 (MMP-3), and vascular endothelial growth factor (VEGF) in patients with RA and to explore the mechanism of moxibustion in the treatment of RA.
Methods


We recruited 70 RA patients who met the inclusion criteria, and they were randomly divided into two groups, a treatment group and a control group in equal ratio. The control group took methotrexate, folate, or leflunomide orally, while the treatment group received methotrexate, folate, or leflunomide orally and moxibustion at ST36 (Zusanli), BL23 (Shen shu), and Ashi points. We compared the clinical symptoms, RA serological disease markers and serum contents of interleukin-1 β  (IL-1 β ), tumor necrosis factor- α  (TNF- α ), MMP-1, MMP-3, and VEGF of RA patients before and after treatment.
Results


(1) The clinical symptoms and RA serological disease markers of the two groups improved after treatment ( P  < 0.05), while the clinical symptoms of the treatment group were significantly improved in comparison with the control group ( P  < 0.05). (2) The levels of IL-1 β , TNF- α,  and VEGF decreased in both groups after treatment ( P  < 0.05), but the treatment group was significantly decreased compared with the control group ( P  < 0.05). (3) There were significant differences in MMP-1 and MMP-3 contents after treatment in the treatment group ( P  < 0.05,  P  < 0.05), while there were no significant differences in the control group ( P  > 0.05,  P  > 0.05). Above all, the contents of IL-1 β , TNF- α , MMP-1, MMP-3, and VEGF in the treatment group decreased more significantly than those in the control group ( P  < 0.05).
Conclusion


The improvement effect of moxibustion on the clinical symptoms of RA patients may be related to influence on the contents of IL-1 β , TNF- α , MMP-1, MMP-3, and VEGF, and moxibustion may play a potential role in bone protection.",2020,"The levels of IL-1 β , TNF- α,  and VEGF decreased in both groups after treatment ( P  < 0.05), but the treatment group was significantly decreased compared with the control group ( P  < 0.05).","['70 RA patients who met the inclusion criteria', 'patients with RA', 'Patients with Rheumatoid Arthritis']","['control group in equal ratio', 'Moxibustion', 'methotrexate, folate, or leflunomide orally, while the treatment group received methotrexate, folate, or leflunomide orally and moxibustion at ST36 (Zusanli), BL23 (Shen shu), and Ashi points', 'moxibustion']","['clinical symptoms and RA serological disease markers', 'Serum Levels of MMP-1, MMP-3, and VEGF', 'clinical symptoms, RA serological disease markers and serum contents of interleukin-1 β  (IL-1 β ), tumor necrosis factor- α  (TNF- α ), MMP-1, MMP-3, and VEGF', 'levels of IL-1 β , TNF- α,  and VEGF', 'contents of IL-1 β , TNF- α , MMP-1, MMP-3, and VEGF', 'MMP-1 and MMP-3 contents', 'clinical symptoms']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450617', 'cui_str': 'BL23'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127082', 'cui_str': 'Interstitial Collagenase'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",70.0,0.029826,"The levels of IL-1 β , TNF- α,  and VEGF decreased in both groups after treatment ( P  < 0.05), but the treatment group was significantly decreased compared with the control group ( P  < 0.05).","[{'ForeName': 'Zeyun', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Yingni', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Liao', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': ""Chengdu Fifth People' Hospital, Chengdu 611130, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Yuanzhang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Tao', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Sichuan, Chengdu 610075, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7150605']
2460,33014209,Preferences for breast cancer prevention among women with a  BRCA1  or  BRCA2  mutation.,"Background


Women with a  BRCA1  or  BRCA2  mutation have high lifetime risks of developing breast and ovarian cancer. The decision to embark on risk reduction strategies is a difficult and personal one. We surveyed an international group of women with  BRCA  mutations and measured choices and sequence of breast cancer risk reduction strategies.
Methods


Women with a  BRCA1/2  mutation and no previous cancer diagnosis were recruited from the US, Canada, the UK, Australia, and from a national advocacy group. Using an online survey, we asked about cancer-risk reduction preferences including for one of two hypothetical medicines, randomly assigned, and women's recommendations for a hypothetical woman (Susan, either a 25- or 36-year-old). Sunburst diagrams were generated to illustrate hierarchy of choices.
Results


Among 598 respondents, mean age was 40.9 years (range 25-55 years). Timing of the survey was 4.8 years (mean) after learning their positive test result and 33% had risk-reducing bilateral salpingo-oophorectomy (RRBSO) and bilateral mastectomy (RRBM), while 19% had RRBSO only and 16% had RRBM only. Although 30% said they would take a hypothetical medicine, 6% reported taking a medicine resembling tamoxifen. Respondents were 1.5 times more likely to select a hypothetical medicine for risk reduction when Susan was 25 than when Susan was 36. Women assigned to 36-year-old Susan were more likely to choose a medicine if they had a family member diagnosed with breast cancer and personal experience taking tamoxifen.
Conclusions


Women revealed a willingness to undergo surgeries to achieve largest reduction in breast cancer risk, although this would not be recommended for a younger woman in her 20s. The goal of achieving the highest degree of cancer risk reduction is the primary driver for women with  BRCA1  or  BRCA2  mutations in selecting an intervention and a sequence of interventions, regardless of whether it is non-surgical or surgical.",2020,Respondents were 1.5 times more likely to select a hypothetical medicine for risk reduction when Susan was 25 than when Susan was 36.,"[' mean age was 40.9\u2009years (range 25-55\u2009years', 'younger woman in her 20s', '\n\n\nWomen with a  BRCA1  or  BRCA2  mutation', 'Methods\n\n\nWomen with a  BRCA1/2  mutation and no previous cancer diagnosis', 'women with a  BRCA1  or  BRCA2  mutation', 'women with  BRCA  mutations and measured choices and sequence of breast cancer risk reduction strategies', '598 respondents']",['tamoxifen'],['risk-reducing bilateral salpingo-oophorectomy (RRBSO) and bilateral mastectomy (RRBM'],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy'}]",,0.0575736,Respondents were 1.5 times more likely to select a hypothetical medicine for risk reduction when Susan was 25 than when Susan was 36.,"[{'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Mansfield', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, 3040 Cornwallis Road, PO Box 12194, Durham, NC 27709-12194 USA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Metcalfe', 'Affiliation': ""Women's College Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Snyder', 'Affiliation': 'Creighton University, Omaha, NE USA.'}, {'ForeName': 'Geoffrey J', 'Initials': 'GJ', 'LastName': 'Lindeman', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Posner', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, 3040 Cornwallis Road, PO Box 12194, Durham, NC 27709-12194 USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Facing Our Risk of Cancer Empowered (FORCE) Advocacy Organization, Tampa, Florida USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Lynch', 'Affiliation': 'Creighton University, Omaha, NE USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Narod', 'Affiliation': ""Women's College Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': 'Manchester Centre for Genomic Medicine, MAHSC, Division of Evolution and Genomic Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Liede', 'Affiliation': 'AbbVie Inc, Dublin, Ireland.'}]",Hereditary cancer in clinical practice,['10.1186/s13053-020-00152-z']
2461,33014220,The general public's ability to operate automated external defibrillator: A controlled simulation study.,"BACKGROUND


Automated external defibrillators (AEDs) enable laypeople to provide early defibrillations to patients undergoing cardiac arrest, but scant information is available on the general public's ability to use AEDs. This study assessed the ability of laypeople to operate AEDs, the effect of a 15-minute training, and whether skills differed by age.
METHODS


From May 1 to December 31, 2018, a prospective simulation study was conducted with 94 laypeople aged 18-65 years (32 aged 18-24 years, 34 aged 25-54 years, and 28 aged 55-65 years) with no prior AED training. The participants' AED skills were assessed individually pre-training, post-training, and at a three-month follow-up using a simulated cardiac arrest scenario. The critical actions and time intervals were evaluated during the AED operating process.
RESULTS


Only 14 (14.9%) participants (eight aged 18-24 years, four aged 25-54 years, and two aged 55-65 years) successfully delivered defibrillations before training. AED operation errors were more likely to occur among the participants aged 55-65 years than among other age groups. After training, the proportion of successful defibrillations increased significantly (18-24 years old: 25.0% vs. 71.9%,  P <0.01; 25-54 years old: 11.8% vs. 70.6%,  P <0.01; 55-65 years old: 7.1% vs. 67.9%,  P <0.01). After three months, 26.1% of the participants aged 55-65 years successfully delivered defibrillations, which was significantly lower than that of participants aged 18-24 years (54.8%) and 25-54 years (64.3%) ( P =0.02). There were no differences in time measures among three age groups in each test.
CONCLUSIONS


The majority of untrained laypeople cannot effectively operate AEDs. More frequent training and refresher courses are crucial to improve AED skills.",2020,"After training, the proportion of successful defibrillations increased significantly (18-24 years old: 25.0% vs. 71.9%,  P <0.01; 25-54 years old: 11.8% vs. 70.6%,  P <0.01; 55-65 years old: 7.1% vs. 67.9%,  P <0.01).","['94 laypeople aged 18-65 years (32 aged 18-24 years, 34 aged 25-54 years, and 28 aged 55-65 years) with no prior AED training', 'participants aged 55-65 years than among other age groups', 'patients undergoing cardiac arrest', 'Only 14 (14.9%) participants (eight aged 18-24 years, four aged 25-54 years, and two aged 55-65 years) successfully delivered defibrillations before training']",[],"['time measures', 'proportion of successful defibrillations']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}]",8.0,0.0324799,"After training, the proportion of successful defibrillations increased significantly (18-24 years old: 25.0% vs. 71.9%,  P <0.01; 25-54 years old: 11.8% vs. 70.6%,  P <0.01; 55-65 years old: 7.1% vs. 67.9%,  P <0.01).","[{'ForeName': 'Xue-Jie', 'Initials': 'XJ', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yue-Lin', 'Initials': 'YL', 'LastName': 'Yu', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shu-Xiao', 'Initials': 'SX', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiao-Chen', 'Initials': 'XC', 'LastName': 'Yang', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiao-Qian', 'Initials': 'XQ', 'LastName': 'Zhang', 'Affiliation': 'School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Myklebust', 'Affiliation': 'Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Guo-Hong', 'Initials': 'GH', 'LastName': 'Li', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zheng', 'Affiliation': 'School of Public Health, Peking University, Beijing, China.'}]",World journal of emergency medicine,['10.5847/wjem.j.1920-8642.2020.04.006']
2462,33014299,Effect of Vasodilatory Medications on Blood Pressure in Patients Undergoing Transradial Coronary Angiography: A Comparative Study.,"Background


In patients undergoing coronary intervention, different vasodilators are used to prevent the radial artery spasm (RAS). To date, no studies investigated the effect of these vasodilators in blood pressure (BP) reduction.
Aim


The study aimed to investigate and compare the effect of vasodilatory medications on BP reduction in patients undergoing transradial coronary angiography procedure.
Methods


We consecutively included 300 patients undergoing transradial coronary angiography procedures and randomly assigned them into three equal groups to compare the effect of verapamil (2.5 mg), nitroglycerin (200 μg), and combination (verapamil 2.5 mg with nitroglycerin 200 (μg) was diluted in 5 ml of normal saline and given through radial sheath. Changes in the BP, heart rate (HR), and other clinical parameters were assessed and presented as standardized mean differences (SMD) with 95% confidence intervals (CIs). ANOVA test was performed to analyze the differences in the BP and other clinical parameters between the three groups.
Results


Overall, the mean age of the study population was 53.26 years (standard deviation: 9.27), male patients (84%), with dyslipidemia (62.6%), and diabetes (45%). At baseline, the mean systolic BP (SBP) was 150.91 ± 31.66 mmHg, HR (72.34 ± 12.71 beats/min). After the administration of vasodilators, the combination group reduced SBP significantly (SMD: -33.35 [95% CI]: -40.27--26.42,  P  < 0.001). There was a statistically significant difference between groups for the SBP ( F  [2,296] =3.38,  P  = 0.035). Verapamil alone showed a significant decrease in the SBP by -27.23 mmHg and diastolic BP by -4.980 mmHg.
Conclusion


Intra-arterial administration of verapamil alone showed lower BP reduction compared to the combination of vasodilators. Verapamil could be a safer and effective alternative to prevent RAS with no deleterious effect on BP and HR in patients undergoing transradial coronary angiography.",2020,"Verapamil alone showed a significant decrease in the SBP by -27.23 mmHg and diastolic BP by -4.980 mmHg.
","['Patients Undergoing Transradial Coronary Angiography', 'patients undergoing transradial coronary angiography procedure', '300 patients undergoing', 'patients undergoing transradial coronary angiography', 'mean age of the study population was 53.26 years (standard deviation: 9.27), male patients (84%), with dyslipidemia (62.6%), and diabetes (45']","['nitroglycerin (200 μg), and combination (verapamil 2.5 mg with nitroglycerin 200 (μg) was diluted in 5 ml of normal saline and given through radial sheath', 'vasodilatory medications', 'vasodilators', 'transradial coronary angiography procedures', 'Vasodilatory Medications', 'Verapamil', 'verapamil']","['radial artery spasm (RAS', 'BP, heart rate (HR), and other clinical parameters', 'blood pressure (BP) reduction', 'Blood Pressure', 'mean systolic BP (SBP', 'lower BP reduction', 'diastolic BP', 'BP reduction', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",300.0,0.188913,"Verapamil alone showed a significant decrease in the SBP by -27.23 mmHg and diastolic BP by -4.980 mmHg.
","[{'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Shehab', 'Affiliation': 'Department of Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, UAE.'}, {'ForeName': 'Akshaya Srikanth', 'Initials': 'AS', 'LastName': 'Bhagavathula', 'Affiliation': 'Department of Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, UAE.'}, {'ForeName': 'Al Anee', 'Initials': 'AA', 'LastName': 'Kaes', 'Affiliation': 'Consultant Cardiologist, Mediclinic Al Ain Hospital, Al Ain, UAE.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Ragy', 'Affiliation': 'Consultant Cardiologist, National Heart Institute, Cairo, Egypt.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Consultant Cardiologist, Mediclinic Al Ain Hospital, Al Ain, UAE.'}, {'ForeName': 'Ibrahim Mahmoud', 'Initials': 'IM', 'LastName': 'El Mansour', 'Affiliation': 'Consultant Cardiologist, Mediclinic Al Ain Hospital, Al Ain, UAE.'}, {'ForeName': 'Eman Eman', 'Initials': 'EE', 'LastName': 'Said Elkeshk', 'Affiliation': 'Consultant Cardiologist, Mediclinic Al Ain Hospital, Al Ain, UAE.'}]",Heart views : the official journal of the Gulf Heart Association,['10.4103/HEARTVIEWS.HEARTVIEWS_114_19']
2463,33014330,Effects of stratified medication review in high-risk patients at admission to hospital: a randomised controlled trial.,"Background


Patients at high risk of medication errors will potentially benefit most from medication reviews. An algorithm, MERIS, can identify the patients who are at highest risk of medication errors. The aim of this study was to examine the effects of performing stratified medication reviews on patients who according to MERIS were at highest risk of medication errors.
Methods


A randomised controlled trial was performed at the Acute Admissions Unit, Aarhus University Hospital, Denmark. Patients were included at admission to the hospital and were randomised to control or intervention. The intervention consisted of stratified medication review at admission on patients with a high MERIS score. Clinical pharmacists and clinical pharmacologists performed the medication reviews; the clinical pharmacologists performed the reviews on patients with the highest MERIS score. The primary outcome measure was the number of prescribing errors during the hospitalisation. Secondary outcomes included self-experienced quality of life, health-care utilisation and mortality measured at follow-up 90 days after discharge.
Results


A total of 375 patients were included, of which medication reviews were performed in 64 patients. The medication reviews addressed 63 prescribing errors in 37 patients and 60 other drug-related problems. No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (95% CI: 0.09-0.16), respectively. No differences in secondary outcomes were observed.
Conclusion


A stratified medication review approach based on the individual patient's risk of medication errors did not show impact on the chosen outcomes.
Plain language summary


How does a medication review at admission affect patients who are in high risk of medication errors?  Patients are at risk of medication errors at admission to hospital. Medication reviews aim to detect and solve these. Yet, due to limited resources in healthcare, it would be beneficial to detect the patients who are most at risk of medication errors and perform medication reviews on those patients.In this study we investigated whether an algorithm, MERIS, could detect patients who are at highest risk of medication errors; we also studied whether performing medication reviews on patients at highest risk of medication errors would have an effect on, for example, the number of medication errors during hospitalisation, qualify of life and number of readmissions. We included 375 patients in a Danish acute admission unit and they were divided into control group and intervention group. Patients in the intervention group received a medication review at admission if they were considered at high risk of medication errors, assessed with the aid of MERIS. In summary, 64 patients in the intervention group were most at risk of medication errors and therefore received a medication review.We conclude in the study that MERIS was useful in identifying relevant patients for medication reviews. Yet, the medication reviews performed at admission did not impact on the chosen outcomes.",2020,"No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (","['A total of 375 patients were included, of which medication reviews were performed in 64 patients', '375 patients in a Danish acute admission unit and they were divided into control group and intervention group', 'patients who according to MERIS were at highest risk of medication errors', 'patients who are at highest risk of medication errors', '37 patients and 60 other drug-related problems', 'Acute Admissions Unit, Aarhus University Hospital, Denmark', 'Patients were included at admission to the hospital', 'high-risk patients at admission to hospital']",['MERIS'],"['number of prescribing errors during hospitalisation', 'self-experienced quality of life, health-care utilisation and mortality', 'number of prescribing errors during the hospitalisation', 'risk of medication errors']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}]",375.0,0.0520952,"No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (","[{'ForeName': 'Dorthe Krogsgaard', 'Initials': 'DK', 'LastName': 'Bonnerup', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Randers Regional Hospital, Dronningborg Boulevard 16D, DK-8930 Randers NØ, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Research Centre for Emergency Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Eva Aggerholm', 'Initials': 'EA', 'LastName': 'Sædder', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Truelshøj', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Anita Gorm', 'Initials': 'AG', 'LastName': 'Pedersen', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Lars Peter', 'Initials': 'LP', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620957142']
2464,33014371,Improvement of nutritional intake for the low-income urban dwellers with hypertension in Malaysia.,"Objective


To ascertain the effect of dietary practice modification and a peer-support home blood pressure monitoring program on the nutritional intake (macronutrients and micronutrients), blood pressure and biochemical profiles of hypertension patients in a low-income community setting.
Methods


This is a pre- and post-measurement intervention study conducted in low-income community housing projects in Kuala Lumpur, Malaysia. A total of 90 participants aged 18 years and above with hypertension received intervention. The participants were divided into small groups and received instructions on the use of home blood pressure measurement. They also attended a series of talks on dietary intake modification and exercise demonstration for the first six months (active phase). In another 6 months (maintenance phase), they received only pamphlet and SMS reminders. Their anthropometry, blood pressure, dietary, and biochemical parameter changes were measured at baseline, 6 months, and 12 months of intervention.
Results


Macronutrients and micronutrients showed a significant improvement at the end of 12-month dietary intervention. The energy, carbohydrate, protein, total fat, sodium, and potassium are showing significant reduction from baseline to end of the 12-month intervention. There is no significant reduction in blood pressure. Fasting blood glucose, renal sodium, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol showed a significant improvement, after controlling for age and reported physical activity.
Conclusion


The intervention improved the nutritional intake and biochemical profiles of the low-income urban population with hypertension. This promising result should be replicated in a larger scale study.",2020,"Fasting blood glucose, renal sodium, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol showed a significant improvement, after controlling for age and reported physical activity.
","['90 participants aged 18 years and above with hypertension received intervention', 'low-income community housing projects in Kuala Lumpur, Malaysia', 'hypertension patients in a low-income community setting', 'low-income urban dwellers with hypertension in Malaysia']",['dietary practice modification and a peer-support home blood pressure monitoring program'],"['anthropometry, blood pressure, dietary, and biochemical parameter changes', 'energy, carbohydrate, protein, total fat, sodium, and potassium', 'blood pressure', 'Fasting blood glucose, renal sodium, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol', 'blood pressure and biochemical profiles', 'nutritional intake and biochemical profiles', 'nutritional intake']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337647', 'cui_str': 'City dweller'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",90.0,0.0163403,"Fasting blood glucose, renal sodium, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol showed a significant improvement, after controlling for age and reported physical activity.
","[{'ForeName': 'Nurul Ain', 'Initials': 'NA', 'LastName': 'Azizan', 'Affiliation': 'Center of Population Health (CePH), Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hazreen Abdul', 'Initials': 'HA', 'LastName': 'Majid', 'Affiliation': 'Center of Population Health (CePH), Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nahar Mohamed', 'Affiliation': 'Sports Medicine Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tin Tin', 'Initials': 'TT', 'LastName': 'Su', 'Affiliation': 'South East Asia Community Observatory (SEACO), Jeffery Cheah School of Medicine and Health Sciences, Monash University Malaysia, Subang Jaya, Malaysia.'}]",SAGE open medicine,['10.1177/2050312120960563']
2465,33014443,"Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.","Introduction


To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema.
Methods


Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens. Both arms were treated with 5% sodium chloride 6 times a day. After a 7-day treatment period, there was a 7-day washout period, after which the arms were crossed over. Patients were evaluated at days 0 (baseline), 7 (following first treatment allocation), 14 (following washout), and 21 (following second treatment allocation). The primary outcomes were 3 lines of BCVA (best corrected visual acuity) improvement.
Results


In total, 49 patients were enrolled. There was significantly greater BCVA improvement rate >3 lines (30.4% versus 17.4%,  P =0.04) in the Therapeutic Hyper-CL™ lens group. The mean change in BCVA lines was significantly greater for the Therapeutic Hyper-CL™ lens (3.4 ± 6.7 versus 0.9 ± 2.3,  P =0.02).
Conclusions


The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride. This trial is registered with NCT02660151.",2020,The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride.,"['Chronic corneal edema patients', 'chronic corneal edema', 'Corneal Edema', '49 patients were enrolled']","['sodium chloride', 'Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens', 'Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L', 'standard bandage contact lens combined with 5% sodium chloride']","['safety and efficacy', 'BCVA improvement rate >3 lines', '3 lines of BCVA (best corrected visual acuity) improvement', 'mean change in BCVA lines', 'visual acuity improvement']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1562032', 'cui_str': 'Bandage contact lens'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",49.0,0.0381482,The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride.,"[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Daphna', 'Affiliation': 'EyeYon Medical, Ness Tziona, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus, Affiliated to the Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Yariv', 'Initials': 'Y', 'LastName': 'Keshet', 'Affiliation': 'Department of Ophthalmology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Meydan', 'Initials': 'M', 'LastName': 'Ben Ishai', 'Affiliation': 'Department of Ophthalmology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Irina S', 'Initials': 'IS', 'LastName': 'Barequet', 'Affiliation': 'Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Knyazer', 'Affiliation': 'Department of Ophthalmology, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Mrukwa-Kominek', 'Affiliation': 'Department of Ophthalmology, Silesian University of Medicine, Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zarnowski', 'Affiliation': 'Department of Diagnostics and Microsurgery of Glaucoma, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Malca', 'Initials': 'M', 'LastName': 'Chen-Zion', 'Affiliation': 'EyeYon Medical, Ness Tziona, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Marcovich', 'Affiliation': 'Department of Ophthalmology, Kaplan Medical Center and the Weizmann Institute of Science, Rehovot, Israel.'}]",Journal of ophthalmology,['10.1155/2020/8410920']
2466,33014452,Addition of the Electronic Educational Material to Doctor's Face-to-Face Education Has No Additive Effects on Hypertension Control: A Randomized Single Blind Study.,"Background


Patient education is effective for HTN treatment. There are many methods of patient education improving HTN control. Are there additive effects of combination of different educational methods for HTN treatment?
Objective


To assess the effects of addition of the electronic educational material to doctor's face-to-face education for HTN control.
Method


We designed a randomized single blind study to compare the doctor's face-to-face education alone and its combination with the electronic educational material over the cell phone. Participants were patients with a confirmed diagnosis of primary HTN. Electronic educational material over the cell phone was the intervention. Main measures were standard blood pressure measurements before and after 12 weeks of treatment.
Result


The baseline characteristics of the intervention and control groups including the age, sex, SBP, DBP, and HTN control rate were not significantly different. After 12 weeks of follow-up, the blood pressure and the HTN control rate seemed worse in the combination group; however, the differences between the intervention group and the control group were not statistically significant.
Conclusion


There were no additive effects in the combination of the doctor's face-to-face education and the electronic educational material over the cell phone.",2020,"After 12 weeks of follow-up, the blood pressure and the HTN control rate seemed worse in the combination group; however, the differences between the intervention group and the control group were not statistically significant.
",['Participants were patients with a confirmed diagnosis of primary HTN'],"[""Electronic Educational Material to Doctor's Face-to-Face Education"", 'electronic educational material', ""doctor's face-to-face education alone and its combination with the electronic educational material""]","['blood pressure and the HTN control rate', 'Hypertension Control', 'age, sex, SBP, DBP, and HTN control rate', 'standard blood pressure measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",,0.0387179,"After 12 weeks of follow-up, the blood pressure and the HTN control rate seemed worse in the combination group; however, the differences between the intervention group and the control group were not statistically significant.
","[{'ForeName': 'John Yang', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of General Practice, Shenzhen People's Hospital, Southern University of Science and Technology (SUSTech), Shenzhen, China.""}, {'ForeName': 'Dihua', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'The Jingmi Community Health Service Center affiliated to Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian), Shenzhen, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of General Practice, Shenzhen People's Hospital, Southern University of Science and Technology (SUSTech), Shenzhen, China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of General Practice, Shenzhen People's Hospital, Southern University of Science and Technology (SUSTech), Shenzhen, China.""}, {'ForeName': 'Huihon', 'Initials': 'H', 'LastName': 'Piao', 'Affiliation': ""Department of General Practice, Shenzhen People's Hospital, Southern University of Science and Technology (SUSTech), Shenzhen, China.""}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': ""Department of General Practice, Shenzhen People's Hospital, Southern University of Science and Technology (SUSTech), Shenzhen, China.""}]",International journal of hypertension,['10.1155/2020/8275945']
2467,32951512,Acute psychosocial stress increases third-party helping but not punishing behavior.,"Despite extensive research on the effects of stress on the brain and behaviors, there is a debate whether stress promotes prosocial behaviors, especially acute stress due to intricate costly punishment in the ultimatum game. Therefore, the present study introduced an irrelevant third party to examine how acute stress and the triggered cortisol influence third parties' punishing and helping behaviors as more convincing altruistic behaviors. The 65 participants were exposed to a psychosocial stressor ( n  = 33) or a control condition ( n  = 32). Afterwards, two third-party intervention tasks (a token allocation task and criminal scenario judgment task) were completed, during which the participants, as an ""irrelevant"" third party, could choose whether to sacrifice their own interests to help the victim or punish the transgressor. Participants' affective states, heart rate, and salivary cortisol were repeatedly measured throughout the experiment. Results showed that acute stress can lead to more third-party helping behaviors but not more punishing behaviors. Specifically, participants under stress tended to transfer more monetary units to the victim in the token allocation task than the control-group participants, and they tended to help the victim in the scenario task. In contrast, there was no significant difference in punishing behavior between the stressed and control participants. These findings reveal that acute psychosocial stress triggers the ""tend and befriend"" response, which might reflect the prosocial intuition under acute stress.",2020,"In contrast, there was no significant difference in punishing behavior between the stressed and control participants.",['65 participants were exposed to a'],['psychosocial stressor ( n \u2009=\u200933) or a control condition'],"['punishing behavior', 'affective states, heart rate, and salivary cortisol']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0458279', 'cui_str': 'Punishing'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",65.0,0.0217142,"In contrast, there was no significant difference in punishing behavior between the stressed and control participants.","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhen', 'Affiliation': 'Psychological Health Education and Counseling Center, Ocean University of China, Qingdao, China.'}, {'ForeName': 'Huagen', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shaozheng', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1825672']
2468,33002792,Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial.,"BACKGROUND


Early rehabilitation has been proved very important for stroke patients. However, the effective model of transitioning from early in-hospital rehabilitation to discharge rehabilitation using the collaborative remote rehabilitation nursing model has not been thoroughly studied.
OBJECTIVE


To explore the feasibility and effectiveness of collaborative care model based telerehabilitation exercise training for acute stroke patients.
METHODS


A randomized controlled clinical trial was conducted. Patients were recruited and randomly divided into intervention and control group. Both groups were given regular treatment and acute rehabilitation nursing instructions during hospitalization. The control group was followed by regular telephone follow-up after discharge. The intervention group received Internet-based remote rehabilitation project after discharge. Motor function, balance ability and quality of life were measured at the day of discharge, the 4 th  week, 8 th  week and 12 th  week after patients were discharged. The CONSORT checklist was used to check the procedure.
RESULTS


A total of 61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group. Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78). Group-time interaction was significant in motor function and quality of life.
CONCLUSION


Collaborative care model based telerehabilitation exercise training program can safely and effectively improve the recovery of motor function and improve the quality of life in patients with stroke.",2020,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","['Acute Stroke Patients in China', 'acute stroke patients', 'stroke patients', '61 patients completed the study, 30 cases in the intervention group and 31 cases in the control group', 'patients with stroke']","['Collaborative Care Model Based Telerehabilitation Exercise Training Program', 'collaborative care model based telerehabilitation exercise training', 'Internet-based remote rehabilitation project']","['Fugl-Meyer Motor Function Assessment', 'Berg Balance Scale', 'motor function and quality of life', 'Motor function, balance ability and quality of life', 'quality of life', 'Stroke-Specific Quality of Life Scale', 'recovery of motor function']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",61.0,0.0446921,"Both groups were significantly improved in terms of motor function and quality of life, but the intervention group showed greater improvement in Fugl-Meyer Motor Function Assessment (intervention group = 83.70 ± 4.44, control group = 75.29 ± 2.89), Berg Balance Scale (intervention group = 43.13 ± 2.32, control group = 38.29 ± 2.70) and Stroke-Specific Quality of Life Scale (intervention group = 190.57 ± 5.09, control group = 175.90 ± 5.78).","[{'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 958414840@qq.com.'}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Outpatient Office, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 13255107918@163.com.'}, {'ForeName': 'Chunxian', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Department of neurology, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China. Electronic address: 1210906885@qq.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Tzu Chi elderly care service center, Changzhou, Jiangsu, China. Electronic address: 18262284203@qq.com.'}, {'ForeName': 'Yongchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of nursing, Taihu University of Wuxi, Wuxi, Jiangsu, China. Electronic address: yongchun0526@163.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105328']
2469,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE


The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN


A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING


Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS


63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS


All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES


Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS


Significant interaction Group*Time effects scales (F 2,126  = 5.1, p-level = 0.005, η² p  = 0.25; F 2,126  = 4.7, p-level = 0.007, η² p  = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION


The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
2470,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND


Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS


33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS


Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION


HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
2471,33007851,Comparison of Skeletal and Dental Changes Obtained from a Tooth-Borne Maxillary Expansion Appliance Compared to the Damon System Assessed through a Digital Volumetric Imaging: A Randomized Clinical Trial.,"The purpose of this study was to evaluate and compare dental and skeletal changes associated with the Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT). Eighty-two patients, from The University of Alberta Orthodontic Clinic, were randomly allocated to either Group A or B. Patients in Group A received orthodontic treatment using the Damon brackets. Patients in Group B received treatment using the Hyrax (a type of RME) appliance. CBCT images were taken two times (baseline and after expansion). The AVIZO software was used to locate 18 landmarks (dental and skeletal) on sagittal, axial, and coronal slices of CBCT images. Comparison between two groups showed that transverse movement of maxillary first molars and premolars was much greater in the Hyrax group. The lateral movements of posterior teeth were associated with buccal tipping of crowns. No clinically significant difference in the vertical or anteroposterior direction between the two groups was noted. Alveolar bone next to root apex of maxillary first premolar and molar teeth showed clinically significant lateral movement in the Hyrax group only. The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.",2020,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"['Eighty-two patients, from The University of Alberta Orthodontic Clinic']","['Damon and Rapid Maxillary Expander (RME) expansion using Cone-Beam Computed Tomography (CBCT', 'orthodontic treatment using the Damon brackets', 'Digital Volumetric Imaging', 'Hyrax (a type of RME) appliance']","['vertical or anteroposterior direction', 'transverse movement of maxillary first molars and premolars', 'transverse expansion', 'lateral movements of posterior teeth']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1321060', 'cui_str': 'Transverse movement'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",82.0,0.0286724,The comparison between two groups showed significantly greater transverse expansion of the first molar and first premolars with buccal tipping in the RME group.,"[{'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gianoni-Capenakas', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Major', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Giseon', 'Initials': 'G', 'LastName': 'Heo', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}, {'ForeName': 'Manuel O', 'Initials': 'MO', 'LastName': 'Lagravère', 'Affiliation': 'Faculty of Medicine and Dentistry, Department of Dentistry, Orthodontic Program, University of Alberta, ECHA, 11405-87th Avenue, Edmonton, AB T6G 1C9, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103167']
2472,33007878,Distinct Effects of Acute Aerobic Exercise on Declarative Memory and Procedural Memory Formation.,"Objective:  To investigate the different effects of acute aerobic exercise on the formation of long-term declarative memory (DM) and procedural memory (PM).  Methods:  Twenty-two young men completed DM and PM tasks under three experimental conditions: pre-acquisition exercise, post-acquisition exercise, and no exercise (control). The DM task encompassed word learning, free recall tests both immediately and 1 h later, and a recognition test conducted 24 h after word learning. A serial reaction time task (SRTT) was utilized to assess exercise effects on PM. The SRTT included a sequence learning phase followed by sequence tests 1 h and 24 h later. The exercise program consisted of 30 min of moderate-intensity aerobic exercise.  Results:  In the DM task, compared to the control condition, pre-acquisition exercise, but not post-acquisition exercise, enhanced free recall performance significantly 1 h and 24 h later. The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition. In the PM task, we observed significantly reduced (improved) reaction times at the 24-h test in the post-acquisition exercise condition compared to in the control condition.  Conclusion:  Acute aerobic exercise may enhance long-term DM and PM via effects on different processing periods. For DM, exercise had a pronounced effect during the encoding period, whereas for PM, exercise was found to have an enhancing effect during the consolidation period.",2020,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,['Methods:  Twenty-two young men completed DM and PM tasks under three experimental conditions'],"['pre-acquisition exercise, post-acquisition exercise, and no exercise (control', 'Acute aerobic exercise', 'serial reaction time task (SRTT', 'acute aerobic exercise', 'Acute Aerobic Exercise', 'exercise program consisted of 30 min of moderate-intensity aerobic exercise']","['Declarative Memory and Procedural Memory Formation', 'formation of long-term declarative memory (DM) and procedural memory (PM', ' reaction times', ""target word recognition rate and discriminative index (d') of the recognition test"", 'free recall performance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0561782', 'cui_str': 'Procedural memory'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",22.0,0.0402269,The target word recognition rate and discriminative index (d') of the recognition test were significantly enhanced in both exercise conditions compared to the control condition.,"[{'ForeName': 'Xuru', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai 200438, China.'}]",Brain sciences,['10.3390/brainsci10100691']
2473,33007886,A Low FODMAP Diet Is Nutritionally Adequate and Therapeutically Efficacious in Community Dwelling Older Adults with Chronic Diarrhoea.,"The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP)diet has been extensively researched, but not in the management of older adults with functional gastrointestinal symptoms. This study determines the positive and negative impacts of this dietary treatment in older adults with chronic diarrhea. A non-blinded intervention study was conducted with adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found. Participants followed a dietitian-led low FODMAP diet for six weeks and completed a structured assessment of gastrointestinal symptoms, the Hospital Anxiety and Depression scale, and a four-day food diary before and after the intervention. Twenty participants, mean age 76 years, were recruited. Adherence to the low FODMAP diet was acceptable; mean daily FODMAP intake reduced from 20.82 g to 3.75 g ( p  < 0.001) during the intervention and no clinically significant changes in macro- or micronutrient intakes were observed. There were clinically significant improvements in total gastrointestinal symptoms (pre diet 21.15/88 (standard deviation SD = 10.99), post diet 9.8/88 (SD = 9.58),  p  < 0.001) including diarrhea (pre diet 9.85 (SD = 3.84), post diet 4.05 (SD = 3.86),  p  < 0.001) and significant reductions in anxiety (pre diet 6.11/21 (SD = 4.31), post diet 4.26/21 (SD = 3.38),  p  < 0.05). In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.",2020,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"['older adults with chronic diarrhea', 'Twenty participants, mean age 76 years, were recruited', 'adults over 65 years with chronic diarrhea referred for colonoscopy where no cause was found', 'Community Dwelling Older Adults with Chronic Diarrhoea', 'older adults with functional gastrointestinal symptoms']","['Low FODMAP Diet', 'dietitian-led low FODMAP diet']","['diarrhea', 'acceptable; mean daily FODMAP intake', 'total gastrointestinal symptoms', 'macro- or micronutrient intakes', 'anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0861063', 'cui_str': 'Lead low'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0270022,In older adults the low FODMAP diet is clinically effective and does not jeopardise nutritional intake when supervised by an experienced dietitian.,"[{'ForeName': 'Leigh', 'Initials': 'L', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Skidmore', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wall', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Central Clinical School, Monash University, Melbourne 3004, VIC, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gearry', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12103002']
2474,33007896,KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol.,"Immunosuppressant agents are essential in every transplant recipient's care yet walking the fine line of over- or under-immunosuppression is a constant struggle for both patients and transplant providers alike. Optimization and personalization of immunosuppression has been limited by the need for non-invasive graft surveillance methods that are specific enough to identify organ injury in real time. With this in mind, we propose a pilot study protocol utilizing both donor derived cell free DNA (dd-cfDNA, gene expression profiling (GEP), and machine learning (iBox), called KidneyCare, to assess the feasibility and safety in reducing immunosuppressant exposure without increasing the risk of clinical rejection, graft injury, or allograft loss. Patients randomized to the immunominimization arm will be enrolled in one of two protocols designed to eliminate one immunosuppressant and optimize the dose of the Calcineurin Inhibitors (CNIs) using the KidneyCare platform. All patients will be maintained on dual therapy of either steroids and a low dose CNI, or mycophenolate mofetil (MMF) and low dose CNI. Their outcomes will be compared to patients who have their immunosuppressants managed using standard clinical assessment and treatment protocols to determine the impact of immuno-optimization on graft function, complications, and patient reported outcomes.",2020,Optimization and personalization of immunosuppression has been limited by the need for non-invasive graft surveillance methods that are specific enough to identify organ injury in real time.,['Renal Allografts'],"['mycophenolate mofetil (MMF) and low dose CNI', 'Calcineurin Inhibitors (CNIs) using the KidneyCare platform', 'KidneyCare Guided Immuno-Optimization', 'immunominimization']",[],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1431767', 'cui_str': 'cni protein, Drosophila'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]",[],,0.0346934,Optimization and personalization of immunosuppression has been limited by the need for non-invasive graft surveillance methods that are specific enough to identify organ injury in real time.,"[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Gray', 'Affiliation': 'CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Wolf-Doty', 'Affiliation': 'CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.'}, {'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Sulejmani', 'Affiliation': 'CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Gaber', 'Affiliation': 'Houston Methodist Hospital, 6565 Fannin St. Houston, TX 77030, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': 'Department of Surgery, University of Iowa Medical Center, 200 Hawkins Dr, Iowa City, IA 52242, USA.'}, {'ForeName': 'Basmah', 'Initials': 'B', 'LastName': 'Abdalla', 'Affiliation': 'UCLA Medical Center, 757 Westwood Plaza, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Danovitch', 'Affiliation': 'UCLA Medical Center, 757 Westwood Plaza, Los Angeles, CA 90095, USA.'}]",Methods and protocols,['10.3390/mps3040068']
2475,33007909,Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept.,"BACKGROUND


Combining cognitive behavioral therapy (CBT) for psychosis with another psychosocial intervention comprising virtual reality (VR)-assisted therapy (VRT) may improve targeted outcomes in treatment-resistant schizophrenia patients.
METHODS


Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT and were selected at the end of the study as they desired to continue to achieve improvements with VRT (CBT + VRT). Clinical assessments were administered before/after treatments and at follow-ups. Changes in outcomes were examined using linear mixed-effects models. To gain a more in depth understanding on CBT + VRT, therapists' notes, and open interviews on a sub-group of patients were qualitatively analyzed.
RESULTS


Findings showed that the sequence of both interventions was appreciated by all patients. Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life. Although most of these improvements were in similar range to those observed in our comparative trial, effects of CBT + VRT on depressive symptoms and symptoms of schizophrenia were larger than those found for either intervention alone.
CONCLUSION


This proof of concept is the first to merge gold-standard CBT with VRT for treatment refractory voices and to suggest a certain synergistic effect.",2020,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","['Ten participants having followed CBT were part of our comparative clinical trial comparing VRT to CBT', 'Patients with Treatment-Resistant Schizophrenia']","['cognitive behavioral therapy (CBT', 'CBT + VRT', 'virtual reality (VR)-assisted therapy (VRT', 'VRT (CBT + VRT', 'Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy']","['auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life', 'Auditory Hallucinations', 'depressive symptoms and symptoms of schizophrenia']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}]",,0.0124199,"Several significant improvements were found throughout time points on auditory verbal hallucinations, beliefs about voices, depressive symptoms, symptoms of schizophrenia and quality of life.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dellazizzo', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}, {'ForeName': 'Kingsada', 'Initials': 'K', 'LastName': 'Phraxayavong', 'Affiliation': 'Services et Recherches Psychiatriques AD, Montreal, QC, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': 'Research Center of the Institut Universitaire en Santé Mentale de Montréal, 7331 Hochelaga, Montreal, QC H1N 3V2, Canada.'}]",Journal of clinical medicine,['10.3390/jcm9103169']
2476,33007918,Weight Reduction by the Low-Insulin-Method-A Randomized Controlled Trial.,"Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI,  n  = 15) or waiting list control group (WL,  n  = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (-6.3 kg with (95% confidence interval) (-7.4; -4.5) ( p  < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by -6.7 kg (-9.5; -3.8) ( p  < 0.001) and -6.1 kg (-9.2; -2.7) ( p  < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.",2020,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not.",['individuals with overweight or obesity'],"['low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching', 'starting intervention group (SI,  n  = 15) or waiting list control']","['weight gain', 'weight reduction', 'favour of SI', 'Weight Reduction', 'Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0621233,"Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all  p  < 0.05) in the within-group analysis, while WL did not.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röhling', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Ellinger', 'Affiliation': 'Hochschule Niederrhein, University of Applied Sciences, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': 'Psychiatric-Psychotherapeutic Day-Care Hospital, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kempf', 'Affiliation': 'West-German Centre of Diabetes and Health, Dusseldorf Catholic Hospital Group, 40591 Dusseldorf, Germany.'}]",Nutrients,['10.3390/nu12103004']
2477,33009448,Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation.,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort. We aimed to improve these problems by placing patients in prone crawl position on a newly developed crawl couch (CrC). A group of 10 right-sided breast cancer patients requiring WBI were randomized in this cross-over trial, comparing the CrC to a standard prone breastboard (BB). Laterolateral (LL), craniocaudal (CC) and anterioposterior (AP) set-up errors were evaluated with cone beam CT. Comfort, preference and set-up time (SUT) were assessed. Forty left and right-sided breast cancer patients served as a validation group. For BB versus CrC, AP, LL and CC mean patient shifts were - 0.8 ± 2.8, 0.2 ± 11.7 and - 0.6 ± 4.4 versus - 0.2 ± 3.3, - 0.8 ± 2.5 and - 1.9 ± 5.7 mm. LL shift spread was reduced significantly. Nine out of 10 patients preferred the CrC. SUT did not differ significantly. The validation group had mean patient shifts of 1.7 ± 2.9 (AP), 0.2 ± 3.6 (LL) and - 0.2 ± 3.3 (CC) mm. Mean SUT in the validation group was 1 min longer (P < 0.05) than the comparative group. Median SUT was 3 min in all groups. The CrC improved precision and comfort compared to BB. Set-up errors compare favourably to other prone-WBI trials and rival supine positioning.",2020,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort.","['10 right-sided breast cancer patients requiring WBI', 'placing patients in prone crawl position on a newly developed crawl couch (CrC', 'Forty left and right-sided breast cancer patients']","['Prone positioning for whole-breast irradiation (WBI', 'CrC']","['Median SUT', 'Laterolateral (LL), craniocaudal (CC) and anterioposterior ', 'Mean SUT', 'Comfort, preference and set-up time (SUT', 'LL shift spread']","[{'cui': 'C4042789', 'cui_str': 'Right Sided Breast Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",40.0,0.0157239,"Prone positioning for whole-breast irradiation (WBI) reduces dose to organs at risk, but reduces set-up speed, precision, and comfort.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Deseyne', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium. pieter.deseyne@uzgent.be.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Speleers', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Boute', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Paelinck', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vakaet', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Hulle', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Schoepen', 'Affiliation': 'Industrial Design Center, Faculty of Engineering and Architecture, Ghent University, Marksesteenweg 58, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stouthandel', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Van Greveling', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Post', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Detand', 'Affiliation': 'Industrial Design Center, Faculty of Engineering and Architecture, Ghent University, Marksesteenweg 58, 8500, Kortrijk, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Monten', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Depypere', 'Affiliation': 'Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000, Gent, Belgium.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Veldeman', 'Affiliation': 'Department of Radiation Oncology, Ghent University Hospital, C. Heymanslaan 10, 9000, Gent, Belgium.'}]",Scientific reports,['10.1038/s41598-020-72702-3']
2478,33009542,The Gray Matters App Targeting Health Behaviors Associated with Alzheimer's Risk: Improvements in Intrinsic Motivation and Impact on Diet Quality and Physical Activity.,"OBJECTIVE


We examine if the Gray Matters intervention (education and behavioral self-monitoring app targeting lifestyle risks for Alzheimer's disease [AD]) affected participants' motivation for change and whether high motivation predicts improved diet and physical activity over 6 months.
DESIGN


In this 6-month randomized controlled trial (treatment n=104; control n=42; assessed pre/post intervention) amotivation, external regulation, identified regulation, and intrinsic motivation were assessed via the Situational Motivation Scale (SIMS). Diet quality was assessed via adherence to the DASH diet, and physical activity was assessed in minutes.
PARTICIPANTS


Eligibility criteria included not having significant cognitive impairment. Participants were aged 39-64 (M = 54.17, SD = 6.9), 66% female, 81% married, 90% White, and 80% had a college degree.
INTERVENTION


Treatment included an activity tracker, Gray Matters app, access to booster sessions, contact with a student health coach, and study website.
SETTING


Participants were in the general community.
RESULTS


Independent samples t-tests determined that intrinsic motivation (IM) increased significantly for the treatment group (M = 2.09 SD = 4.82), compared to the control group (M = 1.00 SD = 5.52; t (130) = -3.04, p = .003). Comparing subgroups of people with High vs Low IM we found that High IM males increased vigorous physical activity more than Lower IM males (F(1,42)=5.053, p=.030). Comparing persons aged 58-64 years with High vs Lower IM, High IM persons had less improvement in diet quality F(1,48)=4.538; p=0.038).
CONCLUSION


RCT results support that the Gray Matters AD-focused intervention increased IM, and IM was associated with improved physical activity and diet quality for some subgroups.",2020,"Comparing persons aged 58-64 years with High vs Lower IM, High IM persons had less improvement in diet quality F(1,48)=4.538; p=0.038).
","[""Alzheimer's disease [AD"", 'Participants were aged 39-64 (M = 54.17, SD = 6.9), 66% female, 81% married, 90% White, and 80% had a college degree', 'Participants were in the general community', 'Eligibility criteria included not having significant cognitive impairment']","['Gray Matters intervention (education and behavioral self-monitoring app targeting lifestyle risks', 'Treatment included an activity tracker, Gray Matters app, access to booster sessions, contact with a student health coach, and study website']","['intrinsic motivation (IM', 'adherence to the DASH diet, and physical activity', 'Diet quality', 'vigorous physical activity', 'pre/post intervention) amotivation, external regulation, identified regulation, and intrinsic motivation were assessed via the Situational Motivation Scale (SIMS', 'Health Behaviors', 'Diet Quality and Physical Activity', 'physical activity and diet quality']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0439249,"Comparing persons aged 58-64 years with High vs Lower IM, High IM persons had less improvement in diet quality F(1,48)=4.538; p=0.038).
","[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Schiwal', 'Affiliation': 'Dr. Alex Schiwal, 6800 Old Main Hill, Logan, UT 84322-2905, Phone: 435-797-0532, Email: alex.schiwal@usu.edu.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Fauth', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wengreen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Norton', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1421-5']
2479,32680912,Impact of Improved Biomass and Liquid Petroleum Gas Stoves on Birth Outcomes in Rural Nepal: Results of 2 Randomized Trials.,"BACKGROUND


Few randomized trials have assessed the impact of reducing household air pollution from biomass stoves on adverse birth outcomes in low-income countries.
METHODS


Two sequential trials were conducted in rural low-lying Nepal. Trial 1 was a cluster-randomized step-wedge trial comparing traditional biomass stoves and improved biomass stoves vented with a chimney. Trial 2 was a parallel household-randomized trial comparing vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas. Kitchen particulate matter of 2.5 μm or less (PM 2.5 ) and carbon monoxide (CO) were assessed before and after stove installation. Prevalent and incident pregnancies were enrolled at baseline and throughout the trials. Birth anthropometry was compared across differing exposure times in pregnancy.
RESULTS


In trial 1, the mean 20-hour kitchen PM 2.5  concentration was reduced from 1380 µg/m 3  to 936 µg/m 3 . Among infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA). Adverse birth outcomes were not significantly different with increasing exposure to improved stoves during pregnancy. In trial 2, the mean 20-hour PM 2.5  concentration was 885 µg/m 3  in households with vented biomass and 442 µg/m 3  in those with LPG stoves. Mean birth weight was 2780 g (SD=427) and 2742 g (SD=431), among households with vented and LPG stoves, respectively. Respective percentages for LBW, SGA, and preterm were 23%, 13%, and 42% in the vented stove group and not statistically different from 31%, 17%, and 42% in the LPG group.
CONCLUSIONS


Improved biomass or LPG stoves did not reduce adverse birth outcomes. PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 . Trials that lower indoor air pollution further are needed.",2020,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"['Two sequential trials were conducted in rural low-lying Nepal', 'infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA', 'low-income countries', 'Rural Nepal']","['household air pollution from biomass stoves', 'traditional biomass stoves and improved biomass stoves vented with a chimney', 'Improved Biomass and Liquid Petroleum Gas Stoves', ""vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas""]","['adverse birth outcomes', 'LBW, SGA, and preterm', 'Mean birth weight', 'mean 20-hour kitchen PM 2.5  concentration', 'carbon monoxide (CO', 'Adverse birth outcomes']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}, {'cui': 'C3463996', 'cui_str': 'Liquid Petroleum'}, {'cui': 'C1268549', 'cui_str': 'Gas stove'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.215707,PM 2.5  and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m 3  or intermediate air quality guideline of 37.5 µg/m 3 .,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. jkatz1@jhu.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Breysse', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Zeger', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kozuki', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Global health, science and practice",['10.9745/GHSP-D-20-00011']
2480,21024975,Trial for the treatment of stomatitis by alkalinization.,,1946,,[],[],[],[],[],[],,0.0154021,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'TEISSET', 'Affiliation': ''}]",L' Information dentaire,[]
2481,33010126,[The effects of a clinical therapeutic intervention in pain assessment and management in surgical ICU patients: a before-and-after intervention study on pain intensity and use of analgesia].,"AIMS


the aims of this study were to test the efficacy of a training program in order to reduce pain intensity in surgical ICU patients and improving postoperative pain assessment and management.
METHODS


longitudinal, before and after experimental study. A total of 261 patients, 126 in Group A (before intervention) and 135 in Group B (after intervention) were included. Data were collected prospectively before and after a training intervention and the implementation of a pain management protocol.
RESULTS


a significant reduction was observed in pain intensity scores collected at 6 hours (p=.016) 12 hours (p -.001) and 48 hours (p=.005) postoperatively. Intense pain was most observed in Group A than Group B (RR=1.98; 95% CI= 1.05-3.71, p=.0302). A significantly smaller proportion of patients treated after intervention received morphine (p=.036) and propofol (p=.045). Although there has been no increase in pain assessments, the interval (hours/minutes) between drugs administrations was reduced (Group A 6.35 +1.19 vs Group B 6.21 +0.5) (p=.006). Mechanical ventilation lasted longer in Group A (3.67 days + 6.6 vs 2.44 days + 4.45) (MD = 1.23; 95% CI= -0.1541- 2.6141) (p=.0415).
CONCLUSION


the implementation of the organizational changes on pain prevention in this ICU, using standardized education, led to less pain in surgical ICU patients. However further randomized studies and with larger patient samples are needed.",2020,"RESULTS


a significant reduction was observed in pain intensity scores collected at 6 hours (p=.016) 12 hours (p -.001) and 48 hours (p=.005) postoperatively.","['261 patients, 126 in Group A (before intervention) and 135 in Group B (after intervention) were included', 'surgical ICU patients']","['clinical therapeutic intervention', 'propofol', 'training program', 'CI= -0.1541', 'morphine']","['Intense pain', 'postoperative pain assessment and management', 'pain intensity', 'pain intensity scores', 'Mechanical ventilation', 'pain assessments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}]",261.0,0.0374991,"RESULTS


a significant reduction was observed in pain intensity scores collected at 6 hours (p=.016) 12 hours (p -.001) and 48 hours (p=.005) postoperatively.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Damico', 'Affiliation': ""RN, MSN, Azienda Socio Sanitaria Territoriale (ASST) Lecco.PhD student, Department of Biomedicine and Prevention, University of Rome 'Tor Vergata' (Italy).Email: vdamico87@libero.it.""}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Murano', 'Affiliation': 'RN, MSN, Residenza Sanitaria Assistenziale, Madonna della Neve, Premana Onlus.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Manzoni', 'Affiliation': 'RN, Azienda Socio Sanitaria Territoriale (ASST) Lecco.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Riggio', 'Affiliation': 'MD, Azienda Socio Sanitaria Territoriale (ASST) Lecco.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dal Molin', 'Affiliation': 'RN, MSN, PhD, Department of Translational Medicine, University of Piemonte Orientale, Novara, (Italy).'}]",Professioni infermieristiche,[]
2482,33010148,Effects and Mechanisms of Dapagliflozin Treatment on Ambulatory Blood Pressure in Diabetic Patients with Hypertension.,"BACKGROUND Studies have shown that dapagliflozin has antihypertensive effects. However, the effects and mechanisms of dapagliflozin on ambulatory blood pressure (ABP) have not been fully evaluated. In this study, we aimed to evaluate the effects of dapagliflozin treatment on ABP in patients with type 2 diabetes and hypertension. MATERIAL AND METHODS Patients were prospectively enrolled and divided into 2 groups: dapagliflozin treatment group (n=182) and no dapagliflozin treatment group (n=304). Clinical characteristics and measures of treatment, serum uric acid (SUA), 24-h urinary UA (UUA) excretion, and 24-h ABP were collected. The effects and mechanisms of dapagliflozin on 24-h ABP were evaluated. RESULTS After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment. After adjusting for covariates, results showed that dapagliflozin treatment was significantly associated with reduced 24-h SBP (ß=-0.29 and P=0.02) and reduced daytime SBP (ß=-0.33 and P=0.009). After additionally adjusting for SUA and 24-h UUA excretion, there were no significant relationships found between dapagliflozin treatment and 24-h (ß=-012, P=0.10) and daytime SBP (ß=-0.20, P=0.06). CONCLUSIONS In patients with diabetes and hypertension, dapagliflozin treatment was associated with reduced 24-h and daytime SBP, which could be related to the drug's effect of increasing 24-h UUA excretion.",2020,"After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment.","['Diabetic Patients with Hypertension', 'patients with type 2 diabetes and hypertension', 'Patients were prospectively enrolled and divided into 2 groups']","['dapagliflozin treatment group (n=182) and no dapagliflozin treatment', 'Dapagliflozin Treatment', 'dapagliflozin']","['reduced daytime SBP', '24-h ABP', 'Ambulatory Blood Pressure', 'daytime SBP', 'reduced 24-h and daytime SBP', '24-h UUA excretion', 'ambulatory blood pressure (ABP', 'serum uric acid (SUA), 24-h urinary UA (UUA) excretion, and 24-h ABP', 'reduced 24-h SBP', 'SUA and 24-h UUA excretion', 'higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.015103,"After 3 months, the patients without dapagliflozin treatment had higher SUA, lower 24-h UUA excretion, and higher 24-h and daytime systolic blood pressure (SBP) (P<0.05) compared to patients with dapagliflozin treatment.","[{'ForeName': 'Zirao', 'Initials': 'Z', 'LastName': 'Hao', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yingzhen', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Guiping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, The Third People's Hospital of Huizhou, Huizhou, Guangdong, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925987']
2483,33017804,Effects of Time of Day on Pacing in a 4-km Time Trial in Trained Cyclists.,"CONTEXT


Time of day has been shown to impact athletic performance, with improved performance observed in the late afternoon-early evening. Diurnal variations in physiological factors may contribute to variations in pacing selection; however, research investigating time-of-day influence on pacing is limited.
PURPOSE


To investigate the influence of time-of-day on pacing selection in a 4-km cycling time trial (TT).
METHODS


Nineteen trained male cyclists (mean [SD] age 39.0 [10.7] y, height 1.8 [0.1] m, body mass 78.0 [9.4] kg, VO2max 62.1 [8.7] mL·kg-1·min-1) completed a 4-km TT on 5 separate occasions at 08:30, 11:30, 14:30, 17:30, and 20:30. All TTs were completed in a randomized order, separated by a minimum of 2 d and maximum of 7 d.
RESULTS


No time-of-day effects were observed in pacing as demonstrated by similar power outputs over 0.5-km intervals (P = .78) or overall mean power output (333.0 [38.9], 339.8 [37.2], 335.5 [31.2], 336.7 [35.2], and 334.9 [35.7] W; P = .45) when TTs were performed at 08:30, 11:30, 14:30, 17:30, and 20:30. Preexercise tympanic temperature demonstrated a time-of-day effect (P < .001), with tympanic temperature higher at 14:30 and 17:30 than at 08:30 and 11:30.
CONCLUSION


While a biological rhythm was present in tympanic temperature, pacing selection and performance when completing a 4-km cycling TT were not influenced by time of day. The findings suggest that well-trained cyclists can maintain a robust pacing strategy for a 4-km TT regardless of time of the day.",2020,"Preexercise tympanic temperature demonstrated a time-of-day effect (P < .001), with tympanic temperature higher at 14:30 and 17:30 than at 08:30 and 11:30.
","['Trained Cyclists', 'y, height 1.8 [0.1]\xa0m, body mass 78.0 [9.4]\xa0kg, VO2max 62.1', 'Nineteen trained male cyclists (mean [SD] age 39.0 [10.7']",[],"['Preexercise tympanic temperature', 'tympanic temperature']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191365', 'cui_str': '10.7'}]",[],"[{'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}]",19.0,0.0690167,"Preexercise tympanic temperature demonstrated a time-of-day effect (P < .001), with tympanic temperature higher at 14:30 and 17:30 than at 08:30 and 11:30.
","[{'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Zadow', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fell', 'Affiliation': ''}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Kitic', 'Affiliation': ''}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Sam S X', 'Initials': 'SSX', 'LastName': 'Wu', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0952']
2484,33017836,The Effects of Nebivolol and Irbesartan on Ambulatory Aortic Blood Pressure and Arterial Stiffness in Hemodialysis Patients with Intradialytic Hypertension.,"BACKGROUND


Intradialytic hypertension occurs in 5-15% of hemodialysis patients and is associated with increased cardiovascular risk, but the responsible mechanisms remain unknown. This study examined the effects of nebivolol and irbesartan on ambulatory central blood pressure (BP), arterial stiffness, and wave-reflection parameters in patients with intradialytic hypertension.
METHODS


This is a prespecified analysis of a single-blind, randomized, cross-over study in 38 hemodialysis patients with intradialytic hypertension. Patients were randomized to nebivolol 5 mg followed byirbesartan 150 mg, or vice versa. In a non-randomized manner, the first half of the patients (n = 19) received a single drug dose 1 h prior to dialysis session and the remaining received the drugs for a whole week before the evaluation. Ambulatory central BP, arterial stiffness, and wave-reflection parameters were estimated with Mobil-O-Graph NG device, during a midweek dialysis day.
RESULTS


Intake of a single dose of nebivolol or irbesartan resulted in lower postdialysis central systolic BP (c-SBP) (baseline: 140.9 ± 15.4; nebivolol: 130.3 ± 19.5, p = 0.009; irbesartan: 127.3 ± 24.4 mm Hg, p = 0.007). Single-dose nebivolol also produced marginally lower 24-h c-SBP (p = 0.064) and lower 24-h central diastolic BP (c-DBP) (p = 0.029). Weekly administration of both drugs reduced postdialysis c-SBP (baseline: 144.1 ± 15.3; nebivolol: 131.8 ± 14.1, p = 0.014; irbesartan: 126.4 ± 17.8, p = 0.001) and 24-h c-SBP and c-DBP (baseline: 135.5 ± 10.3/91.9 ± 9.2; nebivolol: 126.4 ± 8.4/86.6 ± 7.2, p < 0.001/p = 0.002; irbesartan: 128.7 ± 11.6/87.0 ± 9.4, p = 0.061/p = 0.051 mm Hg). Single-dose intake of both drugs did not affect heart rate-adjusted augmentation index [AIx(75)], but decreased postdialysis pulse wave velocity (PWV). Importantly, weekly administration of both drugs reduced 24-h PWV (baseline: 10.0 ± 2.5; nebivolol: 9.7 ± 2.5, p = 0.012; irbesartan: 9.7 ± 2.7, p = 0.041). In between drug-group comparisons, no significant differences were noted.
CONCLUSIONS


This is the first randomized evaluation on the effects of pharmacological interventions on central BP and PWV in patients with intradialytic hypertension. Weekly administration of both nebivolol and irbesartan reduced 24-h central BP and PWV, but not AIx(75).",2020,Single-dose nebivolol also produced marginally lower 24-h c-SBP (p = 0.064) and lower 24-h central diastolic BP (c-DBP) (p = 0.029).,"['patients with intradialytic hypertension', 'Hemodialysis Patients with Intradialytic Hypertension', '38 hemodialysis patients with intradialytic hypertension']","['pharmacological interventions', 'nebivolol', 'nebivolol and irbesartan', 'Nebivolol and Irbesartan', 'nebivolol 5 mg followed byirbesartan 150 mg, or vice versa']","['Ambulatory central BP, arterial stiffness, and wave-reflection parameters', 'central BP and PWV', 'ambulatory central blood pressure (BP), arterial stiffness, and wave-reflection parameters', 'heart rate-adjusted augmentation index [AIx(75', 'postdialysis pulse wave velocity (PWV', 'postdialysis c-SBP', 'lower postdialysis central systolic BP (c-SBP', 'lower 24-h central diastolic BP (c-DBP', '24-h central BP and PWV, but not AIx(75', '24-h c-SBP', 'Ambulatory Aortic Blood Pressure and Arterial Stiffness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C1306211', 'cui_str': 'nebivolol 5 MG'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}]",38.0,0.0262563,Single-dose nebivolol also produced marginally lower 24-h c-SBP (p = 0.064) and lower 24-h central diastolic BP (c-DBP) (p = 0.029).,"[{'ForeName': 'Marieta', 'Initials': 'M', 'LastName': 'Theodorakopoulou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Bikos', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Angeloudi', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Manina', 'Initials': 'M', 'LastName': 'Schoina', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Raptis', 'Affiliation': 'Pieria Hemodialysis Unit, Katerini, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Liakopoulos', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece, psarafidis11@yahoo.gr.'}]",Blood purification,['10.1159/000507913']
2485,33017844,Intermittent Fasting Improves Cardiometabolic Risk Factors and Alters Gut Microbiota in Metabolic Syndrome Patients.,"CONTEXT


Intermittent fasting (IF) is an effective strategy to the improvement of cardiometabolic health.
OBJECTIVE


To examine the effects of IF on cardiometabolic risk factors and the gut microbiota in patients with metabolic syndrome (MS).
DESIGN


Randomized clinical trial.
SETTING


Community Health Service Center.
PATIENTS


Adults with MS, 30-50 years of age.
INTERVENTION


8 weeks of ""two-day"" modified IF.
MAIN OUTCOME MEASURE


Cardiometabolic risk factors including body composition, oxidative stress, inflammatory cytokines, and endothelial function were assessed at baseline and 8 weeks. The diversity, composition, and functional pathways of the gut microbiota, as well as circulating gut-derived metabolites were also measured.
RESULTS


39 patients with MS were included: 21 in the IF group and 18 in the control group. On fasting days, participants in the IF group reduced 69% of the calorie intake compared to nonfasting days. The 8-week IF significantly reduced fat mass, ameliorated oxidative stress, modulated inflammatory cytokines, and improved the vasodilatory parameters. Furthermore, IF induced significant changes in gut microbiota communities, increased the production of short-chain fatty acids (SCFAs), and decreased the circulating levels of lipopolysaccharides (LPS). Gut microbiota alteration attributed to the IF was significantly associated with cardiovascular risk factors and resulted in distinct genetic shifts of carbohydrate metabolism in the gut community.
CONCLUSION


IF induces a significant alteration of the gut microbial community and functional pathways in a manner, which is closely associated with the mitigation of cardiometabolic risk factors. The study provides potential mechanistic insights into the prevention of adverse outcomes associated with MS.",2020,"On fasting days, participants in the IF group reduced 69% of the calorie intake compared to nonfasting days.","['Community Health Service Center', '39 patients with MS were included: 21 in the IF group and 18 in the control group', 'Metabolic Syndrome Patients', 'patients with metabolic syndrome (MS', 'Adults with MS, 30-50 years of age']",[],"['cardiometabolic risk factors', 'fat mass, ameliorated oxidative stress, modulated inflammatory cytokines, and improved the vasodilatory parameters', 'gut microbiota communities', 'Cardiometabolic risk factors including body composition, oxidative stress, inflammatory cytokines, and endothelial function', 'production of short-chain fatty acids (SCFAs', 'calorie intake', 'circulating levels of lipopolysaccharides (LPS']","[{'cui': 'C0009472', 'cui_str': 'Community health services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",39.0,0.0221134,"On fasting days, participants in the IF group reduced 69% of the calorie intake compared to nonfasting days.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Songping', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xia', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition, and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, China.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa644']
2486,33018704,Intramuscular EMG For Abstract Myoelectric Control: A Proof Of Concept Study.,"Myoelectric prostheses are commonly controlled by surface EMG. Many control algorithms, including the user learning-based control paradigm abstract control, benefit from independent control signals. Measuring at the surface of the skin reduces the signal independence through cross talk. To increase the number of independent signals, intramuscular EMG recordings might be a viable alternative for myoelectric control. This proof of concept study investigated if real time abstract myoelectric control is possible with intramuscular measurements. Six participants performed a 4-target and 12-target abstract control task with both surface and intramuscular EMG recordings. The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.",2020,"The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.",[],"['Intramuscular EMG', 'intramuscular EMG', 'Abstract Myoelectric Control', '4-target and 12-target abstract control task with both surface and intramuscular EMG recordings']",[],[],"[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",[],6.0,0.0140845,"The results suggest that intramuscular EMG is suitable for abstract control, and that performance could be increased in the future by stabilizing the amplitude of the processed intramuscular EMG signal.","[{'ForeName': 'Sigrid S G', 'Initials': 'SSG', 'LastName': 'Dupan', 'Affiliation': ''}, {'ForeName': 'Agamemnon', 'Initials': 'A', 'LastName': 'Krasoulis', 'Affiliation': ''}, {'ForeName': 'Kianoush', 'Initials': 'K', 'LastName': 'Nazarpour', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175402']
2487,33018770,Effects of HD-tDCS combined with working memory training on event-related potentials.,"Transcranial direct current stimulation (tDCS) provides a non-invasive approach to modulate brain functions. Some studies have shown that tDCS combined with working memory training can alter the effect of training. This study aims to investigate the effect of HD-tDCS over the left dorsolateral prefrontal cortex combined with N-back task on the amplitude of event related potentials (ERP). In the experiment, subjects performed N-back training for 30min every day with active or sham tDCS for 10 days. EEG data were recorded when subjects performing N-back tests prior to the training, 1 day and 20 days post the training, respectively. With the analyses of ERP components, it was found that there were no significant differences between active and sham groups. However, the results of post-test were significantly different from the pre-test. Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training. Those alterations were enhanced 20 days post training in the active group but not in the sham group. The results indicated the aftereffect of HD-tDCS to promote the effects of cognitive training, showing accumulative positive aftereffects on ERP 20 days after the stimulation.",2020,"Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training.",[],"['Transcranial direct current stimulation (tDCS', 'HD-tDCS', 'HD-tDCS combined with working memory training']","['amplitude of event related potentials (ERP', 'event-related potentials', 'amplitude of ERP']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}]",,0.0366907,"Subsequently, both in active group and in sham group, the amplitude of ERP increased in the frontoparietal and occipital regions 1 day post training.","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Ke', 'Affiliation': ''}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xizi', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ming', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176063']
2488,33018772,Effect of Long-term Transcranial Direct Current Stimulation on Glx and GABA: A Pilot Study.,"Previous studies have demonstrated that transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (dlPFC) can enhance working memory. However, the mechanism underlying the long-term tDCS is still unclear. This pilot study aims to examine neurotransmitters such as gamma-aminobutyric (GABA) and Glx (a measure of glutamate and glutamine combined) and working memory in response to the long-term anodal tDCS over dlPFC. Six healthy, right-handed young adults enrolled in this study received 2-mA anodal tDCS over dlPFC within 4 weeks. Long-term tDCS means that it was applied 5 times per week for the first two weeks and once for the last two weeks with 30 min each time. The other six participants were enrolled as the control group without stimulation for testing the baseline enhancement of working memory due to learning. The GABA and Glx levels were assessed by Magnetic Resonance Spectroscopy (MRS), while a 3-back task was performed to assess working memory. Data were collected at the beginning of the experiment, after two-week tDCS and at the end of the experiment. We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group. Meanwhile, there were no significant changes in the levels of GABA. However, the Glx level was found significantly decreased in both 2- and 4-week MRS measurements. The observation that the long-term tDCS causes the decrease of excitatory neurotransmitters implies the different underlying mechanisms between the long-term tDCS and the single one.",2020,We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group.,"['Six healthy, right-handed young adults']","['2-mA anodal tDCS', 'Long-term Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS']","['levels of GABA', 'GABA and Glx levels', 'Glx and GABA', 'accuracy of response in 3-back', 'working memory', 'Glx level']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",6.0,0.0191738,We found that the working memory was not significantly enhanced by the first two-week tDCS because the accuracy of response in 3-back was not significantly increased compared to the control group.,"[{'ForeName': 'Haonan', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Yanyu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175996']
2489,33018792,The effect of transcranial alternating current stimulation (tACS) on cognitive function in older adults with dementia.,"Recent studies have shown a positive effect of transcranial alternating current stimulation (tACS), a noninvasive brain stimulation technique, on cognitive function of healthy individuals [1]. However, investigation into the effects of tACS on individuals with dementia or mild cognitive impairment (MCI) is lacking. In this pilot study, we investigated the hypothesis that following a regular schedule of challenging brain exercises combined with simultaneous tACS application would improve the working memory and cognitive function of older adults with memory impairments. Further, we explored whether pairing brain exercises with tACS would result in longer-lasting positive effects on cognitive function than brain exercises alone. A total of 17 older adults (12 males, 5 females, 70 ± 7 years), each with a diagnosis of mild to moderate dementia were enrolled in the study. All participants completed brain exercises in the lab on the following schedule: two 30-minute sessions per day, 5 days/week for 4 weeks consecutively. Eleven of the participants received brain exercises paired with tACS application at 40Hz. We evaluated cognitive function of the participants at baseline, post-intervention and 1-month followup using the Wechsler Memory Scale (WMS-IV) as an independent assessment of our brain exercises. Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments. Comparison of the post-intervention and 1-month follow-up assessments indicated that the tACS group maintained their improvement significantly better than the non-tACS group.",2020,Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments.,"['17 older adults (12 males, 5 females, 70 ± 7 years), each with a diagnosis of mild to moderate dementia were enrolled in the study', 'older adults with dementia', 'individuals with dementia or mild cognitive impairment (MCI', 'older adults with memory impairments']","['brain exercises paired with tACS application at 40Hz', 'brain exercises combined with simultaneous tACS application', 'pairing brain exercises with tACS', 'transcranial alternating current stimulation (tACS', 'tACS', 'brain exercises']","['WMS scores', 'cognitive function', 'working memory and cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0175702', 'cui_str': 'Williams syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",17.0,0.0406101,Both the non-tACS and tACS groups significantly improved their WMS scores from baseline to post-intervention assessments.,"[{'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Kehler', 'Affiliation': ''}, {'ForeName': 'Cristina O', 'Initials': 'CO', 'LastName': 'Francisco', 'Affiliation': ''}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Uehara', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moussavi', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175903']
2490,33018842,Therapeutic Effects of an Anti-Gravity Treadmill (AlterG) Training on Neuromuscular Abnormalities Associated with Spasticity in Children with Cerebral Palsy .,"We aimed to characterize the therapeutic effects of Anti-Gravity Treadmill (AlterG) Training on neuromuscular abnormalities associated with spasticity in children with cerebral palsy (CP). Eighteen subjects were divided into two groups; AlterG and control. All subjects received up to 40 minutes of training 3 times a week for 8 weeks. The control group received conventional occupational therapy. The advanced parallel-cascade system identification technique was used to characterize the neuromuscular abnormalities associated with spasticity and separated its intrinsic and reflex components. Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities. Both K and GR were strongly positioned dependent; they varied linearly with the ankle angle at dorsiflexion. Their position dependence was quantified by fitting a linear model to K and GR over dorsiflexion positions. The evaluations were performed at four-time points; i.e. the baseline (before starting the training), 1 and 2 months after starting the training, and 1 month after the completion of the training to assess the persistent effects. We determined the changes in K and GR intercept and slope parameters over these 3 months to evaluate the therapeutic effects of training on neuromuscular abnormalities. The results revealed that all K and GR parameters decreased substantially following using AlterG training and these changes were greater than those observed in the control. The results also showed that these therapeutic effects were persistent to a high extent, particularly in the AlterG group. Our findings suggested that AlterG training could be considered as a robust therapeutic intervention to reduce neuromuscular abnormalities and manage spasticity.",2020,Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities.,"['children with cerebral palsy (CP', 'Children with Cerebral Palsy ', 'Eighteen subjects']","['conventional occupational therapy', 'Anti-Gravity Treadmill', 'AlterG training', 'AlterG) Training']","['Reflex stiffness gain (GR) and intrinsic stiffness gain (K', 'Neuromuscular Abnormalities', 'K and GR parameters']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",18.0,0.013676,Reflex stiffness gain (GR) and intrinsic stiffness gain (K) were used to track the therapeutic effects of training on neural and muscular abnormalities.,"[{'ForeName': 'Sh', 'Initials': 'S', 'LastName': 'Noroozi', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mehrabi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfian', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nooshiravan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175164']
2491,33019104,Development and Validation of a Predictive Model for Hemodynamic Responses to Resuscitation during Uncontrolled Hemorrhage .,"We investigated whether a statistical model could predict mean arterial pressure (MAP) during uncontrolled hemorrhage; such a model could be used for automated decision support, to help clinicians decide when to provide intravascular volume to achieve MAP goals. This was a secondary analysis of adult swine subjects during uncontrolled splenic bleeding. By protocol, after developing severe hypotension (MAP < 60 mmHg), subjects were resuscitated with either saline (NS) or fresh frozen plasma (FFP), determined randomly. Vital signs were documented at quasi-regular time-step intervals, until either subject death or 300 min. Subjects were randomly separated 50%/50% into training/validation sets, and regression models were developed to predict MAP for each subsequent (i.e., future) time-step. Median time-steps for serially recorded vital signs were +15 min. 5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134). The final model consisted of: current MAP; heart rate (HR); prior NS; imminent NS; and imminent FFP. The 95% limits-of-agreement between true subsequent MAP vs. predicted subsequent MAP were +10/-11 mmHg for the 79 time-steps in the training set; and +14/-13 for the 64 time-steps in the validation set. A total of 10 sudden death events (i.e., rapid, fatal MAP decrease within one single time-step) were excluded from analysis. In conclusion, for uncontrolled hemorrhage in a swine model, it was possible to estimate the next documented MAP value on the basis of the subject's current documented MAP; HR; prior NS; and the volume of resuscitation about to be administered. However, the model was unable to predict ""sudden death"" events. The applicability to populations with wider heterogeneity of hemorrhage patterns and with comorbidities requires further investigation.",2020,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,['adult swine subjects during uncontrolled splenic bleeding'],['saline (NS) or fresh frozen plasma (FFP'],"['Median time-steps', 'mean arterial pressure (MAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0520745', 'cui_str': 'Splenic hemorrhage'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.0222451,5 subjects survived the protocol; 17 died after a median time of 87 min (IQR 78 - 134).,"[{'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Reisner', 'Affiliation': ''}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Dubick', 'Affiliation': ''}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Reisner', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176141']
2492,33019480,Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial.,"BACKGROUND


Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH.
METHODS


Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations.
OBJECTIVES


To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH.
TRIAL REGISTRATION NUMBER


ChiCTR1900020888; Pre-results.",2020,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","['patients with early-stage ONFH', 'One hundred twenty eligible participants', 'Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited']","['extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection', 'Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection', 'extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling (""positive"" control group; group M', 'ESWT combined with multiple drilling and intramedullary drug injection']","['Harris Hip Score and the visual analog scale', 'effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441847', 'cui_str': 'Group M'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0948162', 'cui_str': 'Edema of bone marrow'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.140282,"The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema.","[{'ForeName': 'Qianchun', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Rigao', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xueya', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Anorectal Surgery, Nanchong Central Hospital, Nanchong.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xin', 'Affiliation': 'Department of Intensive Care Unit, JianGe County Hospital of Traditional Chinese Medicine, Guangyuan, Sichuan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jian', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}]",Medicine,['10.1097/MD.0000000000022598']
2493,33019504,A Comparison of the Transient Effect of Complex and Core Stability Exercises on Static Balance Ability and Muscle Activation during Static Standing in Healthy Male Adults.,"Balance ability is a necessary exercise factor required for the activities of daily living. This study investigated the effects of short-term complex exercise (CE) and core stability exercise (CSE) on balance ability and trunk and lower-extremity muscle activation on healthy male adults. Twenty-nine healthy male adults were included. All performed CE and CSE for 1 min each; the exercise order was randomized. The primary and secondary outcomes were balance ability and muscle activation, respectively. In balance ability, CE showed a significant difference in all variables in both eye-opened and eye-closed conditions compared with the baseline ( p  < 0.05). In comparisons among exercises, the path length and average velocity variables showed a significant decrease in the eye-opened condition, and the path length variable showed a significant decrease in the eye-closed condition ( p  < 0.05). In muscle activation, CE showed a significant increase in the gluteus medius (Gmed) and decrease in the rectus femoris (RF), tibialis anterior (TA), and RF/biceps femoris (BF) ratio in the eye-opened condition compared to the baseline and a significant decrease in RF and RF/BF ratio in the eye-closed condition ( p  < 0.05). Both CE and CSE improved the static balance ability. Furthermore, muscle activation significantly increases in Gmed and decreases in the RF, TA, and RF/BF ratio. Therefore, we recommend including CE in an exercise program that has the purpose of improving static balance ability.",2020,"In comparisons among exercises, the path length and average velocity variables showed a significant decrease in the eye-opened condition, and the path length variable showed a significant decrease in the eye-closed condition ( p  < 0.05).","['healthy male adults', 'Twenty-nine healthy male adults', 'Healthy Male Adults']","['CE and CSE', 'Complex and Core Stability Exercises', 'short-term complex exercise (CE) and core stability exercise (CSE']","['RF and RF/BF ratio', 'RF, TA, and RF/BF ratio', 'Static Balance Ability and Muscle Activation', 'balance ability and muscle activation, respectively', 'path length and average velocity variables', 'static balance ability', 'eye-closed condition', 'gluteus medius (Gmed) and decrease in the rectus femoris (RF), tibialis anterior (TA), and RF/biceps femoris (BF) ratio']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0224425', 'cui_str': 'Structure of gluteus medius muscle'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}]",29.0,0.0206467,"In comparisons among exercises, the path length and average velocity variables showed a significant decrease in the eye-opened condition, and the path length variable showed a significant decrease in the eye-closed condition ( p  < 0.05).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Jin-Hwa', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, Semyung University, Jecheon 27136, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040375']
2494,33019602,The Influence of Thermal Alterations on Prefrontal Cortex Activation and Neuromuscular Function during a Fatiguing Task.,"The purpose of this study was to examine prefrontal cortex (PFC) activation, neuromuscular function, and perceptual measures in response to a fatiguing task, following thermal alterations of an exercising arm. Nineteen healthy adults completed three experimental sessions. At baseline, participants performed maximum voluntary isometric contractions (MVIC) of the elbow flexors. Next, participants submerged their right arm in a water bath for 15 min. Cold (C), neutral (N), and hot (H) water temperatures were maintained at 8, 33, and 44 °C, respectively. Following water immersion, participants performed an isometric elbow flexion contraction, at 20% of their MVIC, for 5 min. Ratings of perceived exertion (RPE), muscular discomfort, and task demands were assessed. Functional near-infrared spectroscopy was used to measure activation (oxygenation) of the PFC during the fatiguing task. Reductions in MVIC torque at the end of the fatiguing task were greater for the H (25.7 ± 8.4%) and N (22.2 ± 9.6%) conditions, compared to the C condition (17.5 ± 8.9%,  p  < 0.05). The increase in oxygenation of the PFC was greater for the H (13.3 ± 4.9 μmol/L) and N (12.4 ± 4.4 μmol/L) conditions, compared to the C condition (10.3 ± 3.8 μmol/L,  p  < 0.001) at the end of the fatiguing task. The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01). These results indicate that precooling an exercising arm attenuates the rise in PFC activation, muscle fatigue, and psychological rating during a fatiguing task.",2020,"The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01).",['Nineteen healthy adults'],[],"['maximum voluntary isometric contractions (MVIC) of the elbow flexors', 'RPE, muscular discomfort, and task demands', 'oxygenation of the PFC', 'PFC activation, muscle fatigue, and psychological rating', 'Prefrontal Cortex Activation and Neuromuscular Function', 'prefrontal cortex (PFC) activation, neuromuscular function, and perceptual measures', 'MVIC torque', 'Cold (C), neutral (N), and hot (H) water temperatures', 'Ratings of perceived exertion (RPE), muscular discomfort, and task demands']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0337023', 'cui_str': 'Hot water'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",,0.0211816,"The increase in RPE, muscular discomfort, and task demands were greater in the H condition compared to the N and C conditions ( p  < 0.01).","[{'ForeName': 'Kevin Cyle', 'Initials': 'KC', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Verbrigghe', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gabe', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Jauquet', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Eischer', 'Affiliation': 'Department of Kinesiology and Integrative Physiology, Michigan Technological University, 1400 Townsend Dr, Houghton, MI 49931, USA.'}, {'ForeName': 'Tejin', 'Initials': 'T', 'LastName': 'Yoon', 'Affiliation': 'Department of Physical Education, Kangwon National University, 1 Gangwondaehak-gil, Hyoja-dong, Chuncheon-si, Gangwon-do 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197194']
2495,33019646,"Synergistic Effects of Regular Walking and Alkaline Electrolyzed Water on Decreasing Inflammation and Oxidative Stress, and Increasing Quality of Life in Individuals with Type 2 Diabetes: A Community Based Randomized Controlled Trial.","Alkaline electrolyzed water (AEW) and walking are strongly recommended for ameliorating oxidative stress and inflammation. Nevertheless, there is a lack of information on the combination of both on alleviating inflammation, oxidative stress, and improving the quality of life (QoL). We investigated the synergistic effects of drinking AEW and walking on advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL. In total, 81 eligible patients with type 2 diabetes (T2DM) were randomly allocated via single blind to four groups: consumed 2 L/day of AEW ( n  = 20), instructed to walk for 150 min/week ( n  = 20), received a combination of AEW and walking ( n  = 20), and continue their habitual diet and activity ( n  = 21). Data were collected and analyzed before and after 8 weeks of intervention. Our results showed a significant interaction between the group and time, with both AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels. Moreover, the AEW group had a higher physical and total QoL score. The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group. The synergistic effect of AEW and regular walking are an advisable treatment for patients with T2DM.",2020,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","['81 eligible patients with type 2 diabetes (T2DM', 'Individuals with Type 2 Diabetes', 'patients with T2DM']","['AEW and regular walking', 'combination of AEW and walking ( n  = 20), and continue their habitual diet and activity', 'Alkaline electrolyzed water (AEW', 'Regular Walking and Alkaline Electrolyzed Water']","['higher scores in physical, mental and total QoL', 'AEW and walking independently and synergistically ameliorating AGEs, AOPPs, MDA, NLR and WBCs levels', 'Inflammation and Oxidative Stress, and Increasing Quality of Life', 'advanced glycation end products (AGEs), advanced oxidation protein products (AOPPs), malondialdehyde (MDA), white blood cells (WBCs), neutrophil-lymphocyte ratio (NLR) and QoL', 'quality of life (QoL', 'higher physical and total QoL score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",81.0,0.0258548,"The walking group and the combined group had higher scores in physical, mental and total QoL compared to the control group.","[{'ForeName': 'Yohanes Andy', 'Initials': 'YA', 'LastName': 'Rias', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}, {'ForeName': 'Adi Lukas', 'Initials': 'AL', 'LastName': 'Kurniawan', 'Affiliation': 'Research Center for Healthcare Industry Innovation, National Taipei University of Nursing and Health Sciences, 365 Ming-te Road, Beitou District, Taipei 112, Taiwan.'}, {'ForeName': 'Ching Wen', 'Initials': 'CW', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taipei 11031, Taiwan.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Camperdown 2050, Australia.'}, {'ForeName': 'Hsiu Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei 11031, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9100946']
2496,33019861,Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with PTSD and Mild TBI.,"Difficulties in executive-control functions are common sequelae of both Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD). The goal of this study was to assess whether a cognitive rehabilitation training that was successfully applied in civilian and military TBI would be effective for military Veterans with comorbid PTSD and mild TBI (mTBI). In the prior study, Veterans with history of mild to severe TBI significantly improved after Goal-Oriented Attentional Self-Regulation (GOALS) training on measures of attention/executive function, functional task performance, and emotional regulation. The objective of this study was to assess effects of GOALS training in Veterans with comorbid PTSD and mTBI. Forty Veterans with current PTSD diagnosis and history of mTBI (6+ months post) were randomized to either five weeks of GOALS or Brain-Health Education (BHE) training matched in time and intensity. Evaluator-blinded assessments at baseline and post-training included neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation. After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41]. Additionally, GOALS, but not BHE participants indicated significant decrease in PTSD symptoms (PCL-M Total Score) [F=4.80, p=.05, Cohen's d =.60], and demonstrated improvement on complex functional task performance -GPS Learning and Memory [F=5.06, p=.05, Cohen's d =.56]. Training in attentional self-regulation applied to participant defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI. Improving cognitive control functioning may also improve functioning in other domains such as emotional regulation and functional performance, potentially making it particularly relevant for Veterans with history of mTBI and co-morbid psychiatric symptoms.",2020,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","['military Veterans with comorbid PTSD and mild TBI (mTBI', 'Forty Veterans with current PTSD diagnosis and history of mTBI (6+ months post', 'Veterans with PTSD and Mild TBI', 'Veterans with comorbid PTSD and mTBI', 'Veterans with history of mTBI and co-morbid psychiatric symptoms']","['GOALS training', 'Goal-Oriented Attention Self-Regulation Training', 'cognitive rehabilitation training', 'Attentional Self-Regulation (GOALS) training', 'GOALS or Brain-Health Education (BHE) training']","['Overall Complex Attention/Executive Function neuropsychological performance composite', 'complex functional task performance -GPS Learning and Memory', 'cognitive functioning', 'attention/executive function, functional task performance, and emotional regulation', 'Overall Mood Disturbance -POMS emotional regulation self-report', 'neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation', 'PTSD symptoms (PCL-M Total Score', 'Executive Functioning']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0438524,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Novakovic-Agopian', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Lainie', 'Initials': 'L', 'LastName': 'Posecion', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; lposecion@paloaltou.edu.'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Kornblith', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; erica.kornblith@va.gov.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Abrams', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Burciaga', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; joaquinburciaga@gmail.com.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Carlin', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; Gerald.carlin@va.gov.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Groberio', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; Jessica.Chang1@va.gov.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Maruyama', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, United States; brian.maruyama@va.gov.'}, {'ForeName': 'Anthony J-W', 'Initials': 'AJ', 'LastName': 'Chen', 'Affiliation': 'VA Northern California Health Care System, Martinez, California, United States.'}]",Journal of neurotrauma,['10.1089/neu.2019.6806']
2497,33019888,A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study.,"BACKGROUND


Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care.
METHODS


Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome.
FINDINGS


Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care ( n  = 81; 33%), usual care-plus ( n  = 82; 33%) or VERSE ( n  = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group ( n  = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group ( n  = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events ( p  = 0.72).
INTERPRETATION


Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.",2020,"There was no difference between groups in non-fatal or fatal adverse events ( p  = 0.72).
","['13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care ( n \u2009=\u200981; 33', 'Participants with aphasia following acute stroke', '17 acute-care hospitals across Australia/New Zealand from 2014 to 2018', 'after acute stroke']","['VERSE', 'usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy', 'usual care-plus', 'intensive aphasia therapy']","['Communication recovery', 'non-fatal or fatal adverse events', 'improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ', 'communication recovery']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4273775', 'cui_str': 'Western Aphasia Battery Revised'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]",217.0,0.290293,"There was no difference between groups in non-fatal or fatal adverse events ( p  = 0.72).
","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Godecke', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Technology NSW, Broadway, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ciccone', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Rose', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst, Australia.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whitworth', 'Affiliation': 'Faculty of Health Sciences, Curtin University, Bentley, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'Speech Language Pathology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke and Ageing Research, School of Clinical Science at Monash Health, Monash University, Clayton, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020961926']
2498,33019891,Role of Vitamin D Supplements in Prevention of Hungry Bone Syndrome after Successful Parathyroidectomy for Primary Hyperparathyroidism: A Prospective Study.,"BACKGROUND


We postulated that the preoperative correction of vitamin D levels can significantly reduce the incidence of hunger bone syndrome among patients undergoing parathyroidectomy for primary hyperparathyroidism.
METHODS


We performed a prospective, randomized, open-label study on 102 patients with primary hyperparathyroidism and coexisting vitamin D deficiency who were scheduled to undergo parathyroidectomy. Patients were divided into the following two groups: group I which included 52 patients who did not receive preoperative vitamin D supplementation; and group II which included 50 patients who received cholecalciferol 1000-2000 IU daily or 50000 IU weekly until they achieve vitamin D levels >20 ng/mL (group IIa = 25 patients) or vitamin D levels >30 ng/mL (group IIb = 25 patients).
RESULTS


The incidence of hunger bone syndrome in group IIb was lower than group I and group IIa (8% versus 16% versus 23%, respectively); however, this difference did not reach the level of statistical significance (p = 0.22). Patients with hunger bone syndrome were significantly younger and had higher serum phosphorus, alkaline phosphatase, magnesium, and bone mineral density at baseline than patients without hunger bone syndrome. On the other hand, patients with hunger bone syndrome had significantly lower 25-hydroxyvitamin D at baseline than patients without hunger bone syndrome (p = 0.001). The ROC curve showed that the baseline level of serum 25-hydroxyvitamin D was not an independent discriminator of hunger bone syndrome (area under curve = 0.21 (95% CI: 0.06-0.34); p = 0.011).
CONCLUSION


Preoperative course of vitamin D supplements has no preventive role on the postoperative incidence of hunger bone syndrome among patients with primary hyperparathyroidism and coexisting vitamin D deficiency undergoing parathyroidectomy.",2020,"Patients with hunger bone syndrome were significantly younger and had higher serum phosphorus, alkaline phosphatase, magnesium, and bone mineral density at baseline than patients without hunger bone syndrome.","['102 patients with primary hyperparathyroidism and coexisting vitamin D deficiency who were scheduled to undergo parathyroidectomy', 'patients undergoing parathyroidectomy for primary hyperparathyroidism', 'Patients with hunger bone syndrome', 'patients with primary hyperparathyroidism and coexisting vitamin D deficiency undergoing parathyroidectomy', 'Hungry Bone Syndrome after Successful Parathyroidectomy for Primary Hyperparathyroidism']","['vitamin D supplements', '52 patients who did not receive preoperative vitamin D supplementation', 'cholecalciferol 1000-2000\u2009IU daily or 50000\u2009IU weekly until they achieve vitamin D levels ', 'Vitamin D Supplements']","['hunger bone syndrome', 'serum phosphorus, alkaline phosphatase, magnesium, and bone mineral density', 'serum 25-hydroxyvitamin D', '25-hydroxyvitamin D', 'vitamin D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0342635', 'cui_str': 'Hungry bone syndrome'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319613', 'cui_str': '50000'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",102.0,0.102087,"Patients with hunger bone syndrome were significantly younger and had higher serum phosphorus, alkaline phosphatase, magnesium, and bone mineral density at baseline than patients without hunger bone syndrome.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Salman', 'Affiliation': 'General Surgery Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rabiee', 'Affiliation': 'Internal Medicine Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salman', 'Affiliation': 'Internal Medicine Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Youssef', 'Affiliation': 'Internal Medicine Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'E-D Shaaban', 'Affiliation': 'National Hepatology and Tropical Medicine Research Institute, Gastroenterology and Hepatology, Cairo, Egypt.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ftohy', 'Affiliation': 'Head and Neck Surgery, Sohag University, Sohag, Egypt.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Maurice', 'Affiliation': 'General Surgery Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Balamoun', 'Affiliation': 'General Surgery Department, Kasralainy School of Medicine, Cairo University, Cairo, Egypt.'}]",Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society,['10.1177/1457496920962601']
2499,33019892,A Causal Pathway of Physical Activity to Motor Competence in Childhood:Evidence from a School-based Intervention.,"This study aimed to examine whether changes in physical activity (PA) after an 8-week pedometer-based intervention would result in changes on motor competence through competence beliefs towards physical education (PE). The study also evaluated whether the hypothesized causal pathway differed by gender. Participants were 259 children (Mean  age   = 10.88,  SD  =.78), randomly allocated to three intervention groups. Children's PA, competence beliefs towards PE, and motor competence were measured at pre- and post-tests. Significant relationships between PA and competence beliefs towards PE were found at pre- and post-tests. The magnitude of the relationship between competence beliefs towards PE and motor competence was larger at post-test than at pre-test (.33 vs.20). The structural invariance test suggested that the differences between boys and girls for the hypothesized models were insignificant (CMIN = 15.97, df = 12;  p  =.193). In general, the results suggest that changes on PA may cause changes in competence beliefs towards PE, which could result in changes on motor competence in middle to later childhood, regardless of gender. These data offer the possibility of using competence beliefs towards PE as a mediator in PA interventions designed to increase motor competence in childhood.",2020,The magnitude of the relationship between competence beliefs towards PE and motor competence was larger at post-test than at pre-test (.33 vs.20).,"['Participants were 259 children (Mean  age  \xa0=\xa010.88,  SD \xa0=.78', 'Childhood']",[],"['physical activity (PA', ""Children's PA, competence beliefs towards PE, and motor competence""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]",259.0,0.0404059,The magnitude of the relationship between competence beliefs towards PE and motor competence was larger at post-test than at pre-test (.33 vs.20).,"[{'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington , Arlington, TX, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'School of Community Health Sciences, University of Nevada , Reno, Nevada.'}, {'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Kinesiology, University of Michigan , Ann Arbor, MI, USA.'}, {'ForeName': 'Priscila M', 'Initials': 'PM', 'LastName': 'Tamplain', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington , Arlington, TX, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas , Denton, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington , Arlington, TX, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1826666']
2500,33019896,Diabetic Retinopathy and Risk of Stroke: A Secondary Analysis of the ACCORD Eye Study.,"BACKGROUND AND PURPOSE


Diabetic retinopathy (DR) is a common microvascular complication of diabetes, which causes damage to the retina and may lead to rapid vision loss. Previous research has shown that the macrovascular complications of diabetes, including stroke, are often comorbid with DR. We sought to explore the association between DR and subsequent stroke events.
METHODS


This is a secondary analysis of patients enrolled in the ACCORD Eye study (Action to Control Cardiovascular Risk in Diabetes). The primary outcome was stroke during follow-up. The exposure was presence of DR at study baseline. We fit adjusted Cox proportional hazards models to provide hazard ratios for stroke and included interaction terms with the ACCORD randomization arms.
RESULTS


We included 2828 patients, in whom the primary outcome of stroke was met by 117 (4.1%) patients during a mean (SD) of 5.4 (1.8) years of follow-up. DR was present in 874 of 2828 (30.9%) patients at baseline and was more common in patients with than without incident stroke (41.0% versus 30.5%;  P =0.016). In an adjusted Cox regression model, DR was independently associated with incident stroke (hazard ratio, 1.52 [95% CI, 1.05-2.20];  P =0.026). This association was not affected by randomization arm in the ACCORD glucose ( P =0.300), lipid ( P =0.660), or blood pressure interventions ( P =0.469).
CONCLUSIONS


DR is associated with an increased risk of stroke, which suggests that the microvascular pathology inherent to DR has larger cerebrovascular implications. This association appears not to be mediated by serum glucose, lipid, and blood pressure interventions.",2020,"This association was not affected by randomization arm in the ACCORD glucose ( P =0.300), lipid ( P =0.660), or blood pressure interventions ( P =0.469).
","['2828 patients, in whom the primary outcome of stroke was met by 117 (4.1%) patients during a mean (SD) of 5.4 (1.8) years of follow-up', 'Diabetic retinopathy (DR', 'patients enrolled in the ACCORD Eye study (Action to Control Cardiovascular Risk in Diabetes']",[],"['DR', 'Diabetic Retinopathy and Risk of Stroke', 'stroke during follow-up', 'blood pressure interventions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],"[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2828.0,0.113519,"This association was not affected by randomization arm in the ACCORD glucose ( P =0.300), lipid ( P =0.660), or blood pressure interventions ( P =0.469).
","[{'ForeName': 'Ka-Ho', 'Initials': 'KH', 'LastName': 'Wong', 'Affiliation': 'Department of Neurology, The University of Utah, Salt Lake City. (K.-H.W., A.H.d.H., J.J.M., C.P., N.S.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, The University of Utah, Salt Lake City. (K.H.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Peterson', 'Affiliation': 'Department of Neurology, The University of Utah, Salt Lake City. (K.-H.W., A.H.d.H., J.J.M., C.P., N.S.).'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Sheibani', 'Affiliation': 'Department of Neurology, The University of Utah, Salt Lake City. (K.-H.W., A.H.d.H., J.J.M., C.P., N.S.).'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsivgoulis', 'Affiliation': 'Second Department of Neurology, National and Kapodistrian University of Athens, Greece (G.T.).'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Majersik', 'Affiliation': 'Department of Neurology, The University of Utah, Salt Lake City. (K.-H.W., A.H.d.H., J.J.M., C.P., N.S.).'}, {'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'de Havenon', 'Affiliation': 'Department of Neurology, The University of Utah, Salt Lake City. (K.-H.W., A.H.d.H., J.J.M., C.P., N.S.).'}]",Stroke,['10.1161/STROKEAHA.120.030350']
2501,33019950,"The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial.","OBJECTIVE


To examine the impact of front-of-package (FOP) labels on perceived healthfulness, purchasing intentions and understanding of common FOP systems.
DESIGN


A parallel, open-label design randomised participants to different FOP labelling conditions: 'high in' warning labels (WL), multiple traffic light labelling (TLL), health star ratings (HSR) (all displayed per serving) or control with no interpretive FOP labelling. Participants completed a brief educational session via a smartphone application and two experimental tasks. In Task 1, participants viewed healthy or unhealthy versions of four products and rated healthiness and purchasing intention on a seven-point Likert-type scale. In Task 2, participants ranked three sets of five products from healthiest to least healthy.
SETTING


Online commercial panel.
PARTICIPANTS


Canadian residents ≥ 18 years who were involved in household grocery shopping, owned a smartphone and met minimum screen requirements.
RESULTS


Data from 1997 participants (n 500/condition) were analysed. Task 1: across most product categories, the TLL and HSR increased perceived healthiness of healthier products. All FOP systems decreased perceived healthiness of less healthy products. Similar, albeit dampened, effects were seen regarding purchasing intentions. Task 2: participants performed best in the HSR, followed by the TLL, WL and control conditions. Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions.
CONCLUSIONS


All FOP labelling systems, after a brief educational session, improved task performance across a wide spectrum of foods. This effect differed depending on the nutritional quality of the products and the information communicated on labels.Trial Registration: NCT03290118.",2020,"Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions.
","['1997 participants (n 500/condition', 'Canadian residents ≥ 18 years who were involved in household grocery shopping, owned a smartphone and met minimum screen requirements']","['front-of-package (FOP) labels', 'brief educational session via a smartphone application and two experimental tasks', ""FOP labelling conditions: 'high in' warning labels (WL), multiple traffic light labelling (TLL), health star ratings (HSR) (all displayed per serving) or control with no interpretive FOP labelling""]","['Lower health literacy', 'healthiness and purchasing intentions and poorer ranking task performance', 'task performance']","[{'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.171194,"Lower health literacy was associated with higher perceived healthiness and purchasing intentions and poorer ranking task performance across all conditions.
","[{'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences and WHO Collaborating Centre on Nutrition Policy for Chronic Disease Prevention, Faculty of Medicine, University of Toronto, Medical Sciences Building, Room 5368m 1 King's College Circle, Toronto, ON, CanadaM5S 1A8.""}]",Public health nutrition,['10.1017/S1368980020003213']
2502,33019981,No influence of sarcopenia on survival of ovarian cancer patients in a prospective validation study.,"OBJECTIVE


Decrease in skeletal muscle index (SMI) during neoadjuvant chemotherapy (NACT) has been associated with worse outcome in patients with advanced ovarian cancer. To validate these findings, we tested if a decrease in SMI was a prognostic factor for a homogenous cohort of patients who received NACT in the randomized phase 3 OVHIPEC-trial.
METHODS


CT-scans were performed at baseline and after two cycles of neoadjuvant chemotherapy in stage III ovarian cancer patients. The SMI (skeletal muscle area in cm 2  divided by body surface area in m 2 ) was calculated using SliceOMatic software. The difference in SMI between both CT-scans (ΔSMI) was calculated. Cox-regression analyses were performed to analyze the independent effect of a difference in SMI (ΔSMI) on outcome. Log-rank tests were performed to plot recurrence-free (RFS) and overall survival (OS). The mean number of adverse events per patient were compared between groups using t-tests.
RESULTS


Paired CT-scans were available for 212 out of 245 patients (87%). Thirty-four of 74 patients (58%) in the group with a decrease in ΔSMI and 73 of 138 of the patients (53%) in the group with stable/increase in ΔSMI had died. Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups. Patients with a decrease in SMI experienced more pre-operative adverse events, and more grade 3-4 adverse events.
CONCLUSION


Decreased SMI during neoadjuvant chemotherapy was not associated with worse outcome in patients with stage III ovarian cancer included in the OVHIPEC-trial. However, a strong association between decreasing SMI and adverse events was found.",2020,Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups.,"['stage III ovarian cancer patients', 'patients with advanced ovarian cancer', 'patients with stage III ovarian cancer', 'ovarian cancer patients']","['sarcopenia', 'NACT', 'neoadjuvant chemotherapy (NACT', 'neoadjuvant chemotherapy']","['Median RFS and OS', 'plot recurrence-free (RFS) and overall survival (OS', 'ΔSMI', 'SMI', 'SMI (skeletal muscle area', 'SMI experienced more pre-operative adverse events', 'Decreased SMI', 'SMI and adverse events', 'skeletal muscle index (SMI', 'mean number of adverse events']","[{'cui': 'C0278687', 'cui_str': 'Ovarian cancer stage III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",245.0,0.0813561,Median RFS and OS did not differ significantly (p = 0.297 and p = 0.764) between groups.,"[{'ForeName': 'Jorne', 'Initials': 'J', 'LastName': 'Ubachs', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands; Department of Medical Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lahaye', 'Affiliation': 'Department of Radiology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fabris', 'Affiliation': 'Department of Radiology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Bruijs', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Schagen van Leeuwen', 'Affiliation': 'Department of Obstetrics & Gynecology, Sint Antonius Hospital, Koekoekslaan 1, 3435CM Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': 'Department of Gynecological Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584CX Utrecht, the Netherlands.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': 'Department of Gynecology and Obstetrics, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'Department of Gynecological Oncology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ham', 'Affiliation': 'Department of Gynecological oncology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Dam', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Antwerp, Wilrijkstraat 10, 2650 Antwerp, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Medical Oncology, UCLouvain and University of Botswana, CHU Ucl Namur, Belgium.'}, {'ForeName': 'Jacco', 'Initials': 'J', 'LastName': 'Bastings', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Roy F P M', 'Initials': 'RFPM', 'LastName': 'Kruitwagen', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Sandrina', 'Initials': 'S', 'LastName': 'Lambrechts', 'Affiliation': 'Department of Obstetrics and Gynecology, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Steven W M', 'Initials': 'SWM', 'LastName': 'Olde Damink', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; Department of Visceral- and Transplantation Surgery, RWTH Aachen University, Templergraben 55, 52062 Aachen, Germany.'}, {'ForeName': 'Sander S', 'Initials': 'SS', 'LastName': 'Rensen', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, Universiteitssingel 40, 6229ER Maastricht, the Netherlands; NUTRIM, school of Nutrition and Translational Research in Metabolism, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'Van Gorp', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Herestraat 49, 3000 Leuven, Belgium.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, the Netherlands. Electronic address: w.v.driel@nki.nl.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.042']
2503,33020005,Family-centered communication: A pilot educational intervention using deliberate practice and patient feedback.,"OBJECTIVE


There are few opportunities in medical education dedicated to learning skills for effective communication in life altering patient scenarios. We therefore aimed to develop and assess a longitudinal advanced communication curriculum for pediatric residents using patient feedback and deliberate practice.
METHODS


Pediatric residents at a large academic center were randomized into 2 groups. The intervention group received 6 educational sessions from 2019 to 2020, parent feedback of performance via the Communication Assessment Tool (CAT), and monthly communication tips. Communication skills of both groups were assessed at the end of the intervention.
RESULTS


We collected 937 CAT assessments on 36 first-year residents. The intervention group demonstrated statistically significant improvement in communication skills from pre to post assessment (p = 0.0063, (odds ratio (OR) 1.76, 95 % confidence interval (CI) [1.17, 2.63]) compared to the control group (p = 0.080, OR 1.41, 95 % CI [0.96, 2.05]).
CONCLUSIONS


There are patient and self-identified performance gaps in communication skills for pediatric residents, underscoring the need for formalized curricula dedicated to these skills.
PRACTICE IMPLICATIONS


Our study highlights the value of deliberate practice and the integration of family feedback as an educational tool in communication skills development.",2020,"The intervention group demonstrated statistically significant improvement in communication skills from pre to post assessment (p = 0.0063, (odds ratio (OR)","['Pediatric residents at a large academic center', 'pediatric residents using patient feedback and deliberate practice']","['6 educational sessions from 2019 to 2020, parent feedback of performance via the Communication Assessment Tool (CAT), and monthly communication tips']","['Communication skills', 'communication skills']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.0455051,"The intervention group demonstrated statistically significant improvement in communication skills from pre to post assessment (p = 0.0063, (odds ratio (OR)","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Marsh', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH USA. Electronic address: marshmcln@gmail.com.""}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Lauden', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH USA.""}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Mahan', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH USA; The Ohio State University, College of Medicine Columbus, OH USA.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'The Ohio State University, College of Medicine Columbus, OH USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saldivar', 'Affiliation': 'The Ohio State University, College of Medicine Columbus, OH USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hill', 'Affiliation': 'The Ohio State University, College of Medicine Columbus, OH USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'The Ohio State University, College of Medicine Columbus, OH USA.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdel-Rasoul', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH USA; The Ohio State University, College of Medicine Columbus, OH USA.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH USA.""}]",Patient education and counseling,['10.1016/j.pec.2020.09.033']
2504,33020040,The Impact of Navigation Grid Overlay on Performance of Camera Assistants during Laparoscopic Abdominal Procedures: A Randomized Controlled Trial.,"OBJECTIVE


Camera assistance is important for proper visualization of the operative field in laparoscopic surgery. Navigation grid (NG) has been designed to help the camera assistants focus the camera on the target operative field. This is a randomized, controlled trial to study the effect of the NG on performance of camera assistants.
DESIGN


Minimally invasive operations were randomized (1:1) to either with or without use of NG for the camera assistant. The operations were recorded and the time spent inside and outside of the target area were reported.
SETTING


A tertiary care teaching hospital.
RESULTS


Fifty-eight operations (30 with and 28 without NG) were recorded. Sixteen camera assistants participated. Time spent outside the target area was significantly less with the use of NG (64.5 ± 63 seconds vs 396 ± 226.5 seconds; p < 0.0001). This impact of NG on performance of the camera assistants was significant regardless of their level of training.
CONCLUSIONS


NG improved performance of the camera assistant during laparoscopic abdominal procedures. This is a feasible tool that can help camera holders better assist the operating surgeons.",2020,Time spent outside the target area was significantly less with the use of NG (64.5 ± 63 seconds vs 396 ± 226.5 seconds; p < 0.0001).,"['Sixteen camera assistants participated', 'Camera Assistants during Laparoscopic Abdominal Procedures', 'Fifty-eight operations (30 with and 28 without NG', 'A tertiary care teaching hospital', 'Minimally invasive operations']","['Navigation grid (NG', 'Navigation Grid Overlay']",['Time spent outside the target area'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0444456', 'cui_str': 'Overlay'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.16064,Time spent outside the target area was significantly less with the use of NG (64.5 ± 63 seconds vs 396 ± 226.5 seconds; p < 0.0001).,"[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Surgery, College of Medicine, University of Arizona, Tucson, Arizona. Electronic address: iman.ghaderi@gmail.com.'}, {'ForeName': 'Chiu-Hsieh', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Surgery, College of Medicine, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Hines', 'Affiliation': 'Department of Surgery, College of Medicine, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alabagi', 'Affiliation': 'Department of Surgery, College of Medicine, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Galvani', 'Affiliation': 'Department of Surgery, Tulane University, New Orleans, Louisiana.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.09.015']
2505,33020047,A randomized clinical trial to assess the sagittal effects of Transforce transverse appliance (TTA) and NiTi palatal expander (NPE) on skeletal class II malocclusion in growing patients during retention phase - A cephalometric study using a historical control group.,"OBJECTIVES


To evaluate and compare the skeletal changes during the retention period after expansion with ""Transforce Transverse lingual or palatal Appliance®"" (TTA) and ""NiTi Palatal Expander®"" (NPE) in growing subjects with class II division 1 malocclusion and to compare these changes with a matched historical control.
SUBJECTS AND METHODS


A unicentric two arm, parallel randomized clinical trial with additional historical control group was conducted over a period of six years. The subjects in the age group of 9-13 years were screened and recruited as they reported. The inclusion criteria were: late mixed/early permanent dentition, class II or end on molar relationship, posterior transverse inter-arch discrepancy 4-8mm, overjet≥5mm, cephalometrically ANB>4° and CVMI stage CS2-CS3. Subjects were randomly allocated to two study groups (SG), TTA and NPE using block randomization. Appliances in both SG were managed and followed by a single clinician with equal standards of care. The lateral cephalograms in digital form were obtained at the beginning of the treatment (T1), post-expansion (T2) and after ten months retention period (T3). Linear positional change>1mm and angular change>0.75° were considered as a clinically significant change. Due to the ethical reasons a historical control of ten patients (CG) comparable to the SG for age and inclusion criteria was used to rule out the growth changes on serial lateral cephalograms. All Cephalometric measurements were done by a single operator blinded for the group allocation. Operator's measurement error was estimated. The study was single-blinded in regard to statistical analysis. Inter-group comparisons between SG were made by using an unpaired Student's t-test. ANOVA with post-hoc analysis was used for comparison among the study and control groups.
RESULTS


A total of 36 subjects were recruited, 18 in each SG. Average time required to achieve the desired expansion in the TTA and NPE group was 13.6 weeks and 9.8 weeks respectively. The TTA group showed significant increase in SNB (1.54±0.33°) when compared with the control group (0.53±0.37°) and with the NPE group (0.74±0.29°) (P<0.0001). Significant differences were observed when post-retention changes in SNB, ANB, Wits appraisal, and N perpendicular to Pogonion, were compared among the three groups (ANOVA, P<0.0001). Tukey's multiple comparison showed that these mandibular sagittal changes were significantly greater in the TTA group than in NPE and the control group (P=<0.007, Bonferroni corrected value).
CONCLUSION


Cephalometrically significant sagittal advancement of mandible took place after expansion with TTA and NPE compared to untreated control. TTA appears to be more efficient for the sagittal positional changes than the NPE. Additional studies with larger samples are warranted to elucidate individual variations in skeletal response to the expansion protocol with these appliances.",2020,"Tukey's multiple comparison showed that these mandibular sagittal changes were significantly greater in the TTA group than in NPE and the control group (P=<0.007, Bonferroni corrected value).
","['A total of 36 subjects were recruited, 18 in each SG', 'subjects in the age group of 9-13 years were screened and recruited as they reported', 'The inclusion criteria were: late mixed/early permanent dentition, class II or end on molar relationship, posterior transverse inter-arch discrepancy 4-8mm, overjet≥5mm, cephalometrically ANB>4° and CVMI stage CS2-CS3', 'skeletal class II malocclusion in growing patients during retention phase - A cephalometric study using a historical control group', 'subjects with class II division 1 malocclusion']","['NPE', 'Transforce Transverse lingual or palatal Appliance®"" (TTA) and ""NiTi Palatal Expander®"" (NPE', 'TTA', 'Transforce transverse appliance (TTA) and NiTi palatal expander (NPE', 'TTA and NPE']","['Average time required to achieve the desired expansion', 'mandibular sagittal changes', 'post-retention changes in SNB, ANB, Wits appraisal, and N perpendicular to Pogonion', 'SNB']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0068053', 'cui_str': 'N-hydroxysuccinimidyl-5-azido-2-nitrobenzoate'}, {'cui': 'C0043197', 'cui_str': 'Wit as Topic'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}]",36.0,0.0463125,"Tukey's multiple comparison showed that these mandibular sagittal changes were significantly greater in the TTA group than in NPE and the control group (P=<0.007, Bonferroni corrected value).
","[{'ForeName': 'Arun P', 'Initials': 'AP', 'LastName': 'Nagrik', 'Affiliation': 'Dr. SC Government medical college and hospital, department of dentistry, 431606 Nanded, Maharashtra, India. Electronic address: nagrik.arun@gmail.com.'}, {'ForeName': 'Wasundhara A', 'Initials': 'WA', 'LastName': 'Bhad', 'Affiliation': 'Government dental college and hospital, department of orthodontics and dentofacial orthopedics, 444003 Nagpur, Maharashtra, India. Electronic address: wasundhara.bhad@gmail.com.'}, {'ForeName': 'Santosh J', 'Initials': 'SJ', 'LastName': 'Chavan', 'Affiliation': 'Government dental college and hospital, department of orthodontics and dentofacial orthopedics, 444003 Nagpur, Maharashtra, India. Electronic address: drsjchavan@gmail.com.'}, {'ForeName': 'Umal H', 'Initials': 'UH', 'LastName': 'Doshi', 'Affiliation': 'CSMSS dental college and hospital, department of orthodontics and dentofacial orthopedics, 431136 Aurangabad, Maharashtra, India. Electronic address: umal_16@rediffmail.com.'}]",International orthodontics,['10.1016/j.ortho.2020.08.007']
2506,33020052,Intratrial Exposure to Vitamin D and New-Onset Diabetes Among Adults With Prediabetes: A Secondary Analysis From the Vitamin D and Type 2 Diabetes (D2d) Study.,"OBJECTIVE


Postrandomization biases may influence the estimate of efficacy of supplemental vitamin D in diabetes prevention trials. In the Vitamin D and Type 2 Diabetes (D2d) study, repeated measures of serum 25-hydroxyvitamin D [25(OH)D] level provided an opportunity to test whether intratrial vitamin D exposure affected diabetes risk and whether the effect was modified by trial assignment (vitamin D vs. placebo).
RESEARCH DESIGN AND METHODS


The D2d study compared the effect of daily supplementation with 100 μg (4,000 units) of vitamin D 3  versus placebo on new-onset diabetes in adults with prediabetes. Intratrial vitamin D exposure was calculated as the cumulative rolling mean of annual serum 25(OH)D measurements. Hazard ratios for diabetes among participants who had intratrial 25(OH)D levels of <50, 75-99, 100-124, and ≥125 nmol/L were compared with those with levels of 50-74 nmol/L (the range considered adequate by the National Academy of Medicine) in the entire cohort and by trial assignment.
RESULTS


There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018). The hazard ratio for diabetes for an increase of 25 nmol/L in intratrial 25(OH)D level was 0.75 (95% CI 0.68-0.82) among those assigned to vitamin D and 0.90 (0.80-1.02) among those assigned to placebo. The hazard ratios for diabetes among participants treated with vitamin D who maintained intratrial 25(OH)D levels of 100-124 and ≥125 nmol/L were 0.48 (0.29-0.80) and 0.29 (0.17-0.50), respectively, compared with those who maintained a level of 50-74 nmol/L.
CONCLUSIONS


Daily vitamin D supplementation to maintain a serum 25(OH)D level ≥100 nmol/L is a promising approach to reducing the risk of diabetes in adults with prediabetes.",2020,There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018).,"['adults with prediabetes', 'Adults With Prediabetes']","['intratrial vitamin D', 'vitamin D', 'supplemental vitamin D', 'vitamin D 3  versus placebo', 'placebo', 'Intratrial Exposure to Vitamin D and New-Onset Diabetes']","['intratrial 25(OH)D level', 'serum 25-hydroxyvitamin D [25(OH)D] level', 'hazard ratios for diabetes', 'Hazard ratios for diabetes', 'hazard ratio for diabetes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",,0.453158,There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018).,"[{'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA.'}, {'ForeName': 'Myrlene A', 'Initials': 'MA', 'LastName': 'Staten', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Vickery', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Center for Health Research NW, Portland, OR.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Neff', 'Affiliation': 'Division of Endocrinology, Metabolism, and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1765']
2507,33020078,PartnerCARE-a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial.,"INTRODUCTION


Cancer burdens not only the patient but also the partner to a comparable extent. Partners of patients with cancer are highly involved in the caring process and therefore often experience distress and report a low quality of life. Interventions for supporting partners are scarce. Existing ones are rarely used by partners because they are often time-consuming per se and offer only limited flexibility with regard to schedule and location. The online intervention PartnerCARE has been developed on the basis of caregiver needs and consists of six consecutive sessions and four optional sessions, which are all guided by an e-coach. The study aims to evaluate feasibility and acceptance of the online intervention PartnerCARE and the related trial process. In addition, first insights of the putative efficacy of PartnerCARE should be gained.
METHODS AND ANALYSIS


A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group. The study aims to recruit in total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media). Congruent with feasibility study objectives, the primary outcome comprises recruitment process, study procedure, acceptance and satisfaction with the intervention (Client Satisfaction Questionnaire adapted to Internet-based interventions), possible negative effects (Inventory of Negative Effects in Psychotherapy) and dropout rates. Secondary outcomes include quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness. Online measurements will be performed by self-assessment at three time points (baseline/pre-randomisation, 2 months and 4 months after randomisation). Data analyses will be based on intention-to-treat principle.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Ethics Committee of the University of Ulm (No 390/18). Results from this study will be disseminated to relevant healthcare communities, in peer-reviewed journals and at scientific and clinical conferences.
TRIAL REGISTRATION NUMBER


DRKS00017019.",2020,A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group.,"['total n=60 partners of patients with any type of cancer across different access paths (eg, university medical centres, support groups, social media', 'Partners of patients with cancer', 'partners of patients with cancer']","['PartnerCARE', 'PartnerCARE-a psycho-oncological online intervention', 'PartnerCARE online intervention']","['quality of life, distress, depression, anxiety, caregiver burden, fear of progression, social support, self-efficacy, coping and loneliness', 'recruitment process, study procedure, acceptance and satisfaction with the intervention']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",60.0,0.148674,A two-arm parallel-group randomised controlled trial will be conducted to compare the PartnerCARE online intervention with a waitlist control group.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bodschwinna', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany daniela.bodschwinna@uni-ulm.de.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Lorenz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bauereiss', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Gündel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hoenig', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Ulm Medical Center, Ulm, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035599']
2508,33020083,"Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol.","INTRODUCTION


Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most effective treatment involves the use of nimodipine, a calcium channel blocker. Recent studies have suggested that cilostazol, a platelet aggregation inhibitor, may prevent cVS. Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.
METHODS AND ANALYSIS


This is a multicentre, double-blinded, randomised, placebo-controlled superiority trial investigating the effect of cilostazol on DCI. Data concerning rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes will be recorded. All data will be collected with the aim of demonstrating that the use of cilostazol plus nimodipine will safely decrease the incidence of DCI, and decrease the rates of both radiographic and symptomatic vasospasm with subsequent improvement in long-term functional and QoL outcomes when compared with nimodipine alone.
ETHICS AND DISSEMINATION


Ethical approval was obtained from all participating hospitals by the Ascension Providence Hospital Institutional Review Board. The results of this study will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04148105.",2020,"Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.
","['delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage', 'aneurysmal subarachnoid haemorrhage (aSAH']","['cilostazol', 'placebo', 'cilostazol plus nimodipine', 'cilostazol-nimodipine combined therapy', 'nimodipine']","['rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes', 'Efficacy and safety', 'rates of both radiographic and symptomatic vasospasm']","[{'cui': 'C0917798', 'cui_str': 'Cerebral ischemia'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0917798', 'cui_str': 'Cerebral ischemia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.638955,"Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH.
","[{'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Dawley', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Chad F', 'Initials': 'CF', 'LastName': 'Claus', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA chadfclaus@gmail.com.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Tong', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Rajamand', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sigler', 'Affiliation': 'Department of Pharmacy, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bahoura', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Garmo', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Teck M', 'Initials': 'TM', 'LastName': 'Soo', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Kelkar', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'Richards', 'Affiliation': 'Division of Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036217']
2509,33020088,AGT-Reha-WK study: protocol for a non-inferiority trial comparing the efficacy and costs of home-based telerehabilitation for shoulder diseases with medical exercise therapy.,"INTRODUCTION


Shoulder lesions rank among the top 15 diagnoses accounting for days of incapacity to work. Inpatient or full-day outpatient rehabilitation are some of the standard therapies. For sustainable rehabilitation, continuation of rehabilitation after discharge from a rehabilitation centre is vital. Besides medical exercise therapy (MET), home-based physical exercise programmes are used. To monitor exercise quantity and quality, AGT-Reha, a health-enabling technology for home rehabilitation, has been developed and evaluated in a pilot study for technical feasibility and acceptance. To integrate the digital therapeutic AGT-Reha into regular healthcare processes, an efficacy evaluation is required.
METHODS AND ANALYSIS


AGT-Reha-WK is a prospective, monocentric, non-randomised, unblinded non-inferiority trial. Primary objective is to investigate whether AGT-Reha enhanced home-based exercise training is non-inferior to MET as standard aftercare. Secondary objective is to compare the costs of both therapies. Efficacy as medical success (primary outcome) is examined with regard to ability to work, return to work and sustainability of training (secondary outcomes). The outcome measure for non-inferiority is shoulder function (pain and disability) assessed by the standardised Shoulder Pain and Disability Index (SPADI). The non-inferiority margin is set to 10 points on SPADI score using a 95% CI. Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany. The total number of subjects should be 84 (42 per group). Treatment takes 6 months per patient. Subjects will be assessed at four time points: pre-baseline (admission to rehabilitation centre), baseline (discharge from rehabilitation centre), post-therapy and follow-up (3 months post-therapy).
ETHICS AND DISSEMINATION


Ethics approval was granted by the Ethics Committee of Hannover Medical School (ethics approval no: 7313). Results of the trial are planned to be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


German Clinical Trials Register DRKS00011596. Registered 2 June 2017. Recruitment started on 3 March 2017, and it is expected to continue until December 2020.
PROTOCOL VERSION


V2.0, 23 May 2018, Amendment 01: improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica; these changes have no effect on structural equality.",2020,these changes have no effect on structural equality.,"['Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany', 'VERSION\n\n\nV2.0, 23 May 2018, Amendment 01']","['medical exercise therapy', 'AGT-Reha enhanced home-based exercise training', 'medical exercise therapy (MET), home-based physical exercise programmes', 'home-based telerehabilitation']","['ability to work, return to work and sustainability of training (secondary outcomes', 'standardised Shoulder Pain and Disability Index (SPADI', 'improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica', 'non-inferiority is shoulder function (pain and disability']","[{'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0002555', 'cui_str': 'Aminoglutethimide'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.101456,these changes have no effect on structural equality.,"[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Steiner', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School, Technische Universität Braunschweig, Braunschweig, Germany bianca.steiner@plri.de.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Elgert', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Haux', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School, Technische Universität Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Klaus-Hendrik', 'Initials': 'KH', 'LastName': 'Wolf', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics of TU Braunschweig and Hannover Medical School, Hannover, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-036881']
2510,33020090,Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol.,"INTRODUCTION


Type 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
METHODS AND ANALYSIS


21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries.
TRIAL REGISTRATION NUMBER


NCT03938233.",2020,"We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
","['21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients', 'people with diabetes']","['culturally-tailored DSME intervention', 'nurse-led model, a peer-assisted model and standard care', 'nurse-led, peer-assisted (Thai village health volunteers) and standard care']","['changes in haemoglobin A1c and cardiovascular risk score', 'cardiovascular risk and control of blood glucose']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",693.0,0.11453,"We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes.
","[{'ForeName': 'Chaisiri', 'Initials': 'C', 'LastName': 'Angkurawaranon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand chaisiri.a@cmu.ac.th.'}, {'ForeName': 'Iliatha', 'Initials': 'I', 'LastName': 'Papachristou Nadal', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Poppy Alice Carson', 'Initials': 'PAC', 'LastName': 'Mallinson', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kanokporn', 'Initials': 'K', 'LastName': 'Pinyopornpanish', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Quansri', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Salaya, Thailand.'}, {'ForeName': 'Kittipan', 'Initials': 'K', 'LastName': 'Rerkasem', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Supattra', 'Initials': 'S', 'LastName': 'Srivanichakorn', 'Affiliation': 'Royal Thai Government Ministry of Public Health, Bangkok, Thailand.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Techakehakij', 'Affiliation': 'Lampang Hospital, Lampang, Thailand.'}, {'ForeName': 'Nutchanath', 'Initials': 'N', 'LastName': 'Wichit', 'Affiliation': 'Surat Thani Rajabhat University, Surat Thani, Thailand.'}, {'ForeName': 'Chanapat', 'Initials': 'C', 'LastName': 'Pateekhum', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ahmar H', 'Initials': 'AH', 'LastName': 'Hashmi', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hanson', 'Affiliation': 'Department of Global Health and Development, Faculty of Public Health of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, Faculty of Epidemiology and Population Health,London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036963']
2511,33020094,Cognitive behavioural therapy in groups for medicated adults with attention deficit hyperactivity disorder: protocol for a randomised controlled trial.,"INTRODUCTION


Cognitive behavioural therapy (CBT) is an evidence-based treatment for adults with attention deficit hyperactivity disorder (ADHD). However, it is still inconsistent whether a combination of CBT would have additive effects in medicated ADHD in adulthood. And if CBT would have additional effects, what kind and which dimension would CBT play a part? This study estimates the efficacy of CBT in stable medicated adult ADHD, using long-term outcomes and multidimensional evaluations.
METHODS AND ANALYSIS


It is a two-armed, randomised controlled trial on the superiority of the efficacy of 12 weeks of CBT on medicated adult ADHD. We compare the short-term and long-term outcomes between CBT combined with medication (CBT+M) group and the medication-only (M) group, including ADHD core symptoms, emotional symptoms, executive function, self-esteem, life quality and brain function using functional near-infrared spectroscopy data. Participants are outpatients of the Peking University Sixth Hospital and those recruited online, diagnosed as adult ADHD and with stable medication treatment. We estimate ADHD core symptoms and combined symptoms at baseline (T1) and week 12 (T2), week 24 (T3), week 36 (T4) and week 48 (T5).
ETHICS AND DISSEMINATION


This trial has been approved by the Ethics and Clinical Research Committees of Peking University Sixth Hospital and will be performed under the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results will be disseminated in a peer-reviewed journal and a conference presentation.
TRIAL REGISTRATION NUMBER


ChiCTR (ChiCTR1900021705).",2020,"It is a two-armed, randomised controlled trial on the superiority of the efficacy of 12 weeks of CBT on medicated adult ADHD.","['medicated adults with attention deficit hyperactivity disorder', 'adults with attention deficit hyperactivity disorder (ADHD', 'Participants are outpatients of the Peking University Sixth Hospital and those recruited online, diagnosed as adult ADHD and with stable medication treatment']","['Cognitive behavioural therapy (CBT', 'Cognitive behavioural therapy', 'CBT combined with medication (CBT+M', 'CBT']","['ADHD core symptoms, emotional symptoms, executive function, self-esteem, life quality and brain function using functional near-infrared spectroscopy data']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",,0.153236,"It is a two-armed, randomised controlled trial on the superiority of the efficacy of 12 weeks of CBT on medicated adult ADHD.","[{'ForeName': 'Mei-Rong', 'Initials': 'MR', 'LastName': 'Pan', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China.'}, {'ForeName': 'Meng-Jie', 'Initials': 'MJ', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China.'}, {'ForeName': 'Hai-Mei', 'Initials': 'HM', 'LastName': 'Li', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China.'}, {'ForeName': 'Qiu-Jin', 'Initials': 'QJ', 'LastName': 'Qian', 'Affiliation': 'Peking University Sixth Hospital, Institute of Mental Health, Beijing, China qianqiujin@bjmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037514']
2512,33020099,Impact of COPD case finding on clinical care: a prospective analysis of the TargetCOPD trial.,"OBJECTIVES


To investigate the impact of chronic obstructive pulmonary disease (COPD) case finding on clinical care.
DESIGN


We conducted a prospective observational analysis of data from a pragmatic cluster randomised controlled trial in primary care in the West Midlands, UK (TargetCOPD). This compared alternative methods of COPD case finding against usual care. Data were extracted from electronic healthcare records and self-reported questionnaires for a subset of patients with newly diagnosed COPD.
SETTING


50 general practices that participated in the TargetCOPD trial.
PARTICIPANTS


Patients aged 40-79 years newly identified with COPD by targeted case finding or by usual care, from 10 August 2012 to 22 June 2014.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was addition to a COPD register by the end of the trial. The secondary outcome was a clinical care score, derived from the sum of clinical assessments and relevant interventions. Associations between participant characteristics and the primary and secondary outcomes were assessed using multilevel regression.
RESULTS


857 patients identified with COPD by case finding and 764 by usual care were included. Only 21.2% of case-found patients had been added to a COPD register, compared with 92.7% of those diagnosed by usual care. The odds of being added were greater in smokers (adjusted OR 8.68, 95% CI 2.53 to 29.8), and in those with lower percentage of predicted forced expiratory volume in 1 s (adjusted OR 0.96 per percentage rise, 95% CI 0.95 to 0.98). Patients who had been added to a COPD register had a significantly higher clinical care score (mean difference 5.06, 95% CI 4.36 to 5.75).
CONCLUSIONS


Only one in five case-found patients had been registered with COPD. Patients added to a COPD register received significantly higher levels of appropriate clinical care.
TRIAL REGISTRATION NUMBER


ISRCTN14930255; Post-results.",2020,"The odds of being added were greater in smokers (adjusted OR 8.68, 95% CI 2.53 to 29.8), and in those with lower percentage of predicted forced expiratory volume in 1 s (adjusted OR 0.96 per percentage rise, 95% CI 0.95 to 0.98).","['Patients aged 40-79 years newly identified with COPD by targeted case finding or by usual care, from 10 August 2012 to 22 June 2014', 'primary care in the West Midlands, UK (TargetCOPD', '50 general practices that participated in the TargetCOPD trial', '857 patients identified with COPD by case finding and 764 by usual care were included']",[],"['levels of appropriate clinical care', 'forced expiratory volume', 'clinical care score, derived from the sum of clinical assessments and relevant interventions', 'clinical care score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0454882', 'cui_str': 'West Midlands'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.303908,"The odds of being added were greater in smokers (adjusted OR 8.68, 95% CI 2.53 to 29.8), and in those with lower percentage of predicted forced expiratory volume in 1 s (adjusted OR 0.96 per percentage rise, 95% CI 0.95 to 0.98).","[{'ForeName': 'Shamil', 'Initials': 'S', 'LastName': 'Haroon', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK s.haroon@bham.ac.uk.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Dickens', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alice J', 'Initials': 'AJ', 'LastName': 'Sitch', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Rai', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Enocson', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fitzmaurice', 'Affiliation': 'Warwick Medical School - Health Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Jordan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038286']
2513,33020101,Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial.,"INTRODUCTION


Chest physiotherapy (CPT) and intrathoracic percussion ventilation have been recognised as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proven to be sufficient.
METHOD AND ANALYSES


This study aims to examine the tolerance, feasibility and physiological effects in airway clearance by using a novel extrathoracic non-invasive oscillating transducer device (NIOD) in critically ill children. A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children's Hospital will be applied. Children under 24 months old, for whom CPT is prescribed for airway clearance, will be included. The study consists of two stages; (1) Stage 1 'Frequency Level': we will apply two different frequencies of the NIOD (40 Hz vs 60 Hz) for 12 min each, on each patient 3 hours apart, and (2) Stage 2 'NIOD versus CPT': we will implement NIOD and CPT alternatingly for 3 hours apart. The order of the procedures will be randomly allocated for each case. We will compare the average Δchanges of tidal lung volume measured by a 3D imaging system and regional lung functions using electrical impedance tomography, between the two different frequencies and between the NIOD periods and the CPT periods. We will also examine tolerance by seeing COMFORT Scales and related complications during the procedures. We estimate necessary sample size as 6 for each arm (Total 12 cases) for stage 1 and 48 cases for Stage 2, with power of 0.8 and alpha of 0.05.
ETHICS AND DISSEMINATION


This study has been approved by the Health Research Ethics Board of University of Montreal, Canada (REB number: 2020-2471). We will disseminate our findings through peer-reviewed publications and conference presentations in paediatric or/and critical care fields.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03821389).",2020,A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children's Hospital will be applied.,"[""paediatric intensive care unit in a Canadian Academic Children's Hospital"", 'critically ill children']","['Chest physiotherapy (CPT) and intrathoracic percussion ventilation', 'novel extrathoracic non-invasive oscillating transducer device (NIOD', 'CPT', 'non-invasive oscillating device']",['tidal lung volume'],"[{'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume'}]",,0.182582,A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children's Hospital will be applied.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Pediatrics, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Bernier', 'Affiliation': 'Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': 'Systems and Computer Engineering, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Emeriaud', 'Affiliation': 'Pediatrics, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Philippe A', 'Initials': 'PA', 'LastName': 'Jouvet', 'Affiliation': 'Pediatrics, University of Montreal, Montreal, Quebec, Canada philippe.jouvet@umontreal.ca.'}]",BMJ open,['10.1136/bmjopen-2020-038648']
2514,33020105,"A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol.","INTRODUCTION


Neonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.
METHODS AND ANALYSIS


The  S tabilisation with nasal  H igh flow during  I ntubation of  NE onates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks' gestation; ≥28 weeks' gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).
ETHICS AND DISSEMINATION


The SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women's Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.
TRIAL REGISTRATION NUMBER


ACTRN12618001498280.",2020,"Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations.","['neonates', 'preterm infants', 'adults undergoing upper airway surgery and during endotracheal intubation']","['nasal high flow therapy', 'Neonatal endotracheal intubation', 'nasal high flow during neonatal intubation with standard care (no nasal high flow', 'stabilisation with nasal high flow during neonatal endotracheal intubation']","['peripheral oxygen saturation', 'operator success and patient stability', 'incidence of successful intubation on the first attempt without physiological instability of the infant', 'safe apnoea time', 'Rates of successful intubation']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.434288,"Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations.","[{'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Hodgson', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia kate.hodgson@thewomens.org.au.""}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Camille Omar', 'Initials': 'CO', 'LastName': 'Kamlin', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Donath', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brett James', 'Initials': 'BJ', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2020-039230']
2515,33020110,Marriage-based pilot clean household fuel intervention in India for improved pregnancy outcomes.,"INTRODUCTION


Health interventions often target pregnant women and their unborn children. Interventions in rural India targeting pregnant women, however, often do not cover the critical early windows of susceptibility during the first trimester and parts of the second trimester. This pilot seeks to determine if targeting newlyweds could protect entire pregnancies with a clean stove and fuel intervention.
METHODS


We recruited 50 newlywed couples who use biomass as a cooking fuel into a clean cooking intervention that included a liquefied petroleum gas (LPG) stove, two gas cylinders, a table to place the stove on and health education. We first evaluated whether community health workers in this region could identify and recruit couples at marriage. We quantified how many additional days of pregnancy could be covered by an intervention if we recruited at marriage versus recruiting after detection of pregnancy.
RESULTS


On average, we identified and visited newlywed couples within 40 (SD 21) days of marriage. Of the 50 couples recruited, 25 pregnancies and 18 deliveries were identified during this 1-year study. Due to challenges securing fuel from the LPG supply system, not all couples received their intervention prior to pregnancy. Regardless, couples recruited in the marriage arm had substantially more days with the intervention than couples recruited into a similar arm recruited at pregnancy (211 SD 46 vs 120 SD 45). At scale, a stove intervention targeting new marriages would cover about twice as many weeks of first pregnancies as an intervention recruiting after detection of pregnancy.
CONCLUSIONS


We were able to recruit in early marriage using existing community health workers. Households recruited early in marriage had more days with clean fuel coverage than those recruited at pregnancy. Our findings indicate that recruitment at marriage is feasible and warrants further exploration for stove and other interventions targeting pregnancy-related outcomes.",2020,"Regardless, couples recruited in the marriage arm had substantially more days with the intervention than couples recruited into a similar arm recruited at pregnancy (211 SD 46 vs 120 SD 45).","['rural India targeting pregnant women', 'couples recruited in the marriage arm had substantially more days with the intervention than couples recruited into a similar arm recruited at pregnancy (211 SD 46 vs 120 SD 45', '50 newlywed couples who use biomass as a cooking fuel into a clean cooking intervention that included a liquefied petroleum gas (LPG) stove, two gas cylinders, a table to place the stove on and health education', 'pregnant women and their unborn children', '50 couples recruited, 25 pregnancies and 18 deliveries', 'Households recruited early in marriage had more days with clean fuel coverage than those recruited at pregnancy']",[],[],"[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0425381', 'cui_str': 'Newly wed'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],[],50.0,0.105417,"Regardless, couples recruited in the marriage arm had substantially more days with the intervention than couples recruited into a similar arm recruited at pregnancy (211 SD 46 vs 120 SD 45).","[{'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Pillarisetti', 'Affiliation': 'Gangarosa Department of Environmental Health, Rollins School of Public Health, Atlanta, Georgia, USA ajaypillarisetti@gmail.com.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Diamond-Smith', 'Affiliation': 'University of California, San Francisco, California, USA.'}, {'ForeName': 'Makarand', 'Initials': 'M', 'LastName': 'Ghorpade', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Dhongade', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Balakrishnan', 'Affiliation': 'ICMR Center for Advanced Research on Air Quality, Climate and Health, Department of Environmental Health Engineering, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sankar', 'Initials': 'S', 'LastName': 'Sambandam', 'Affiliation': 'ICMR Center for Advanced Research on Air Quality, Climate and Health, Department of Environmental Health Engineering, Faculty of Public Health, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rutuja', 'Initials': 'R', 'LastName': 'Patil', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Levine', 'Affiliation': 'Haas School of Business, University of California, Berkeley, California, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Smith', 'Affiliation': 'Environmental Health Sciences, School of Public Health, University of California, Berkeley, California, USA.'}]",BMJ open,['10.1136/bmjopen-2020-044127']
2516,33020113,Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial.,"INTRODUCTION


Airway clearance techniques (ACTs) are a gold standard of cystic fibrosis management; however, the majority of research evidence for their efficacy is of low standard; often attributed to the lack of sensitivity from outcome measures (OMs) used historically. This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
METHODS AND ANALYSIS


This is a single-centre RCT with crossover design. Participants perform MBW, IOS and spirometry, and then are randomised to either rest or supervised ACT lasting 30-60 min. MBW, IOS and spirometry are repeated immediately afterwards. EIT and sputum are collected during rest/ACT. On a separate day, the OMs are performed with the other intervention. Primary endpoint is difference in change in OMs before and after ACT/rest. Sample size was calculated with 80% power and significance of 5% for each OM (target n=64).
ETHICS AND DISSEMINATION


Ethics approval was gained from the London-Chelsea Research Ethics Committee (reference 16/LO/0995, project ID 154635). Dissemination will involve scientific conference presentation and publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


ISRCTN11220163 and NCT02721498.",2020,"This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
",['adults with cystic fibrosis'],[],"['standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS', 'MBW, IOS and spirometry', 'Sample size', 'change in OMs before and after ACT/rest']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0242753', 'cui_str': 'Io'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.168903,"This randomised controlled trial (RCT) investigates these standard OMs (sputum weight, forced expiratory volume in 1 s) and new OMs (electrical impedance tomography (EIT), multiple breath washout (MBW) and impulse oscillometry (IOS)) to determine the most useful measures of ACT.
","[{'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Stanford', 'Affiliation': 'Adult Cystic Fibrosis, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Charman', 'Affiliation': 'Cystic Fibrosis Trust, London, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Health Sciences, College of Health, Medicine and Life Scientists, Brunel University London, London, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Simmonds', 'Affiliation': 'Adult Cystic Fibrosis, Royal Brompton Hospital, London, UK n.simmonds@imperial.ac.uk.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bilton', 'Affiliation': 'Respiratory Medicine, Royal Brompton Hospital, London, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000694']
2517,33020137,"Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial.","OBJECTIVES


To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison).
METHODS


We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry.
RESULTS


In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events.
CONCLUSIONS


ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.",2020,"In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity.","['patients with shoulder impingement syndrome', '210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months', 'shoulder impingement', '175 participants (83%) completed the 5 years follow-up', 'Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018']","['diagnostic arthroscopy (or exercise therapy', 'Subacromial decompression versus diagnostic arthroscopy', 'placebo', 'placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison', 'arthroscopic subacromial decompression (ASD']","['adverse events', 'pain VAS', 'shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0407864', 'cui_str': 'Diagnostic arthroscopy of joint'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",210.0,0.294734,"In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity.","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland mika.paavola@hus.fi.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kanto', 'Affiliation': 'TAYS Hatanpää/Department of Orthopedics and Traumatology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': 'Centre for Health and Social Economics - CHESS, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Inkinen', 'Affiliation': 'Fysios Finlayson, Tampere, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kalske', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Savolainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pohjola Hospital, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Sinisaari', 'Affiliation': 'Terveystalo Healthcare Services, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Teppo Ln', 'Initials': 'TL', 'LastName': 'Järvinen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2020-102216']
2518,33020354,Fatigue Resistance of Two Nickel-Titanium Rotary Instruments before and after  Ex Vivo  Root Canal Treatment.,"AIM


The aim of the present study is twofold: to evaluate cyclic fatigue resistance differences of two different nickel-titanium rotary instruments, brand new and after an  ex vivo  instrumentation of single root extracted teeth.
MATERIALS AND METHODS


Twenty new S One 20.06 were randomly divided into two groups. The first group ( n  = 10) was immediately subjected to a cyclic fatigue test (S One Group I). The second group ( n  = 10) (S one Group II) performed a cyclic fatigue test after three  ex vivo  root canal treatment with a single-file technique. The same process has been carried out for 20 M-Two 20.06 instruments.
RESULTS


Mean time to fracture (TtF) for Group I was 51.14 ± 1.28 for S One and 32.62 ± 0.17 for M-Two 20.06 and for Group II was 46.00 ± 0.99 for S One and 27.75 ± 1.58 for M-Two 20.06. The reduction in TtF values from Group I to Group II was 11% for S One and 15% for M-Two. Statistical analysis found significant differences in all the groups examined ( p  value < 0.05). Mean fragment length (FL) for Group I was 3.07 ± 0.17 for S One and 3.05 ± 0.14 for M-Two 20.06 and for Group II was 3.05 ± 0.07 for S One and 3.05 ± 0.14 for M-Two 20.06. Statistical analysis was pursued, and no significant difference was found ( p  value > 0.05).
CONCLUSION


The S-One showed significantly more resistance to cyclic fatigue stress than M-Two for both new and used instruments. This validates the hypothesis that the AF H wire enables the S One files to endure more the cyclic fatigue stresses.
CLINICAL SIGNIFICANCE


This study demonstrates the cyclic fatigue resistance of a new endodontic instrument after repetitive usage.",2020,The reduction in TtF values from Group I to Group II was 11% for S One and 15% for M-Two.,['Twenty new S'],['cyclic fatigue test after three  ex vivo  root canal treatment with a single-file technique'],"['Mean fragment length (FL', 'Mean time to fracture (TtF', 'resistance to cyclic fatigue stress', 'cyclic fatigue resistance', 'reduction in TtF values', 'Fatigue Resistance']","[{'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0151704,The reduction in TtF values from Group I to Group II was 11% for S One and 15% for M-Two.,"[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Miccoli', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Seracchiani', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Del Giudice', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy, Phone: +39 3203612748, e-mail: alessandro.mazzoni@uniroma1.it.'}, {'ForeName': 'Maurilio', 'Initials': 'M', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Bhandi', 'Affiliation': 'Department of Restorative Dental Sciences, Jazan University, Kingdom of Saudi Arabia.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gambarini', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Testarelli', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}]",The journal of contemporary dental practice,[]
2519,33020394,Acute Photobiomodulation Does Not Influence Specific High-Intensity and Intermittent Performance in Female Futsal Players.,"The acute improvement of performance after photobiomodulation therapy (PBMT) has been reported in different types of exercise. However, the effect on high-intensity and intermittent exercises that are relevant for team sports is unknown. Thus, we evaluated the effect of prior acute application of PBMT on high-intensity and intermittent exercise performance, muscle oxygenation, and physiological/perceptual indicators in amateur female futsal players. Thirteen players (24.1 ± 3.7 years) performed a testing battery (countermovement jump (CMJ), Illinois agility and YoYo intermittent recovery test level 1 (YYIR1)) preceded by 15 min of PBMT (1 min 30 s each muscular point; five muscular points in each lower limbs) or 15 min of placebo (SHAM), in a counterbalanced randomized cross-over design (one-week in-between PBMT/SHAM). All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses. The acute application of PBMT prior to a physical testing battery does not influence high-intensity and intermittent exercises performance, neither physiological nor perceptual responses in amateur female futsal players.",2020,"All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses.","['Thirteen players (24.1 ± 3.7 years) performed a', 'Female Futsal Players', 'amateur female futsal players']","['photobiomodulation therapy (PBMT', 'testing battery (countermovement jump (CMJ), Illinois agility and YoYo intermittent recovery test level 1 (YYIR1)) preceded by 15 min of PBMT (1 min 30 s each muscular point; five muscular points in each lower limbs) or 15 min of placebo (SHAM', 'PBMT']","['high-intensity and intermittent exercise performance, muscle oxygenation, and physiological/perceptual indicators', 'blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0246837', 'cui_str': ""1,1'-((4,4,7,7-tetramethyl)-4,7-diazaundecamethylene)bis-4-(3-methyl-2,3-dihydro(benzo-1,3-oxazole)-2-methylidine)quinolinium, tetraiodide""}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",,0.145645,"All test performance did not differ ( p  > 0.05) between PBMT and SHAM, as well as blood lactate, rating of perceived exertion, heart rate, and muscle oxygenation (via near infrared spectroscopy) responses.","[{'ForeName': 'Izabela Aparecida Dos', 'Initials': 'IAD', 'LastName': 'Santos', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Marina de Paiva', 'Initials': 'MP', 'LastName': 'Lemos', 'Affiliation': 'Exercise Physiology in Health and Human Performance Research Group, Department of Physical Education, University of Uberaba (UNIUBE), Uberaba 38055-500, Brazil.'}, {'ForeName': 'Vitória Helena Maciel', 'Initials': 'VHM', 'LastName': 'Coelho', 'Affiliation': 'Department of Physiotherapy, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Department of Physical Education, Laboratory of Physiology and Sport Performance (LAFIDE), School of Sciences, Sao Paulo State University (UNESP), Bauru 17033-360, Brazil.'}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Marocolo', 'Affiliation': 'Physiology and Human Performance Research Group, Department of Physiology, Federal University of Juiz de Fora, Juiz de Fora 360360-900, Brazil.'}, {'ForeName': 'Rogério Nogueira', 'Initials': 'RN', 'LastName': 'Soares', 'Affiliation': 'Dalton Cardiovascular Research Center, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Octávio', 'Initials': 'O', 'LastName': 'Barbosa Neto', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}, {'ForeName': 'Gustavo R', 'Initials': 'GR', 'LastName': 'Mota', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Institute of Health Sciences, Federal University of Triangulo Mineiro (UFTM), Uberaba 38025-350, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17197253']
2520,33020411,Effect of a Single Session of Intermittent Hypoxia on Erythropoietin and Oxygen-Carrying Capacity.,"Intermittent hypoxia, defined as alternating bouts of breathing hypoxic and normoxic air, has the potential to improve oxygen-carrying capacity through an erythropoietin-mediated increase in hemoglobin mass. The purpose of this study was to determine the effect of a single session of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young healthy individuals. Nineteen participants were randomly assigned to an intermittent hypoxia group (Hyp,  n  = 10) or an intermittent normoxia group (Norm,  n  = 9). Intermittent hypoxia consisted of five 4-min hypoxic cycles at a targeted arterial oxygen saturation of 90% interspersed with 4-min normoxic cycles. Erythropoietin levels were measured before and two hours following completion of the protocol. Hemoglobin mass was assessed the day before and seven days after exposure to intermittent hypoxia or normoxia. As expected, the intermittent hypoxia group had a lower arterial oxygen saturation than the intermittent normoxia group during the intervention (Hyp: 89 ± 1 vs. Norm: 99 ± 1%,  p  < 0.01). Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15). Hemoglobin mass did not change following exposure to intermittent hypoxia. This single session of intermittent hypoxia was not sufficient to elicit a significant rise in erythropoietin levels or hemoglobin mass in young healthy individuals.",2020,"Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15).","['young healthy individuals', 'Nineteen participants']","['Erythropoietin and Oxygen-Carrying Capacity', 'intermittent hypoxia group (Hyp,  n  = 10) or an intermittent normoxia group']","['Hemoglobin mass', 'erythropoietin levels and hemoglobin mass', 'erythropoietin levels or hemoglobin mass', 'Erythropoietin levels', 'arterial oxygen saturation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733682', 'cui_str': 'Hypophosphatemic Rickets, X-Linked Dominant'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}]",19.0,0.0236488,"Erythropoietin levels did not significantly increase following exposure to intermittent hypoxia (Hyp: 8.2 ± 4.5 to 9.0 ± 4.8, Norm: 8.9 ± 1.7 to 11.1 ± 2.1 mU·mL -1 ,  p  = 0.15).","[{'ForeName': 'Mercedes J', 'Initials': 'MJ', 'LastName': 'Nagel', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}, {'ForeName': 'Caitlin P', 'Initials': 'CP', 'LastName': 'Jarrard', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lalande', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, Austin, TX 78751, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17197257']
2521,33020447,"Effectiveness of ""Hand Hygiene Fun Month"" for Kindergarten Children: A Pilot Quasi-Experimental Study.","Early childhood is a formative period during which healthy habits are developed, including proper hand hygiene practices. The aim of this quasi-experimental study was to determine the effectiveness of a 4-week series of educational sessions that consider the cognitive developmental stage of children on increasing their knowledge and promoting hand hygiene practices. The intervention group ( n  = 33) observed the hand hygiene program, whereas another group served as the waitlist control ( n  = 20). Creative activities were planned for the illustration of hand hygiene concepts in terms of ""right moments"", ""right steps"", and ""right duration"". Hand sanitizer coverage was evaluated using a hand scanner. After the intervention, the experimental group had higher knowledge level toward hand hygiene than the control group ( p  < 0.001). Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group. The study demonstrated that the knowledge and proper hand hygiene (HH) practice of children can be positively influenced by the use of an age-appropriate education program. The results of this study have implications for school health educators and parents for promoting HH practices among children at home and at the school level.",2020,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group.","['Kindergarten Children', 'school health educators and parents for promoting HH practices among children at home and at the school level']","['educational sessions', 'Hand Hygiene Fun Month', 'hand hygiene program, whereas another group served as the waitlist control']","['hand hygiene performance', 'overall hand coverage', 'knowledge level toward hand hygiene']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708552', 'cui_str': 'School health educator'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",,0.0163116,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p  < 0.05), right palm ( p  < 0.05), and overall hand coverage ( p  < 0.05) were observed in the experimental group.","[{'ForeName': 'Lorna Kwai Ping', 'Initials': 'LKP', 'LastName': 'Suen', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Janet Pui Lee', 'Initials': 'JPL', 'LastName': 'Cheung', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}]",International journal of environmental research and public health,['10.3390/ijerph17197264']
2522,33020646,Continuous versus intermittent BRAF and MEK inhibition in patients with BRAF-mutated melanoma: a randomized phase 2 trial.,"Preclinical modeling suggests that intermittent BRAF inhibitor therapy may delay acquired resistance when blocking oncogenic BRAF V600  in melanoma 1,2 . We conducted S1320, a randomized, open-label, phase 2 clinical trial (NCT02196181) evaluating whether intermittent dosing of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib improves progression-free survival in patients with metastatic and unresectable BRAF V600  melanoma. Patients were enrolled at 68 academic and community sites nationally. All patients received continuous dabrafenib and trametinib during an 8-week lead-in period, after which patients with non-progressing tumors were randomized to either continuous or intermittent dosing of both drugs on a 3-week-off, 5-week-on schedule. The trial has completed accrual and 206 patients with similar baseline characteristics were randomized 1:1 to the two study arms (105 to continuous dosing, 101 to intermittent dosing). Continuous dosing yielded a statistically significant improvement in post-randomization progression-free survival compared with intermittent dosing (median 9.0 months versus 5.5 months, P = 0.064, pre-specified two-sided α = 0.2). Therefore, contrary to the initial hypothesis, intermittent dosing did not improve progression-free survival in patients. There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.",2020,"There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.","['206 patients with similar baseline characteristics', 'patients with metastatic and unresectable BRAF V600  melanoma', 'patients with non-progressing tumors', 'patients with BRAF-mutated melanoma', 'Patients were enrolled at 68 academic and community sites nationally']","['Continuous versus intermittent BRAF and MEK inhibition', 'BRAF inhibitor dabrafenib and the MEK inhibitor trametinib', 'BRAF inhibitor therapy', 'continuous dabrafenib and trametinib']","['progression-free survival', 'post-randomization progression-free survival', 'overall survival and the overall incidence of treatment-associated toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0169101', 'cui_str': 'MAP Kinase Kinases'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3838813', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",206.0,0.105021,"There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.","[{'ForeName': 'Alain P', 'Initials': 'AP', 'LastName': 'Algazi', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA. alain.algazi@ucsf.edu.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Othus', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Adil I', 'Initials': 'AI', 'LastName': 'Daud', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'Lo', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Mehnert', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Thach-Giao', 'Initials': 'TG', 'LastName': 'Truong', 'Affiliation': 'Kaiser Permanente Northern California, Vallejo, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'University of Alabama, Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kendra', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gary C', 'Initials': 'GC', 'LastName': 'Doolittle', 'Affiliation': 'University of Kansas Hospital-Westwood Cancer Center, Westwood, KS, USA.'}, {'ForeName': 'Joseph I', 'Initials': 'JI', 'LastName': 'Clark', 'Affiliation': 'Loyola University, Chicago, IL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Messino', 'Affiliation': 'Messino Cancer Centers-Asheville/ Southeast COR NCORP/Asheville, Asheville, NC, USA.'}, {'ForeName': 'Dennis F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Cancer Center of Kansas/Wichita NCORP, Wichita, KS, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lao', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Faller', 'Affiliation': 'Missouri Baptist Medical Center Cancer Center/Heartland NCORP, St Louis, MO, USA.'}, {'ForeName': 'Rangaswamy', 'Initials': 'R', 'LastName': 'Govindarajan', 'Affiliation': 'University of Arkansas, Little Rock, AR, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harker-Murray', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Dreisbach', 'Affiliation': 'Eisenhower Medical Center, Rancho Mirage, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Kenneth F', 'Initials': 'KF', 'LastName': 'Grossmann', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}]",Nature medicine,['10.1038/s41591-020-1060-8']
2523,33020648,"Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i.","Immune and targeted therapies achieve long-term survival in metastatic melanoma; however, new treatment strategies are needed to improve patients' outcomes 1,2 . We report on the efficacy, safety and biomarker analysis from the single-arm safety run-in (part 1; n = 9) and biomarker (part 2; n = 27) cohorts of the randomized, placebo-controlled, phase 3 COMBI-i trial (NCT02967692) of the anti-PD-1 antibody spartalizumab, in combination with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib. Patients (n = 36) had previously untreated BRAF V600-mutant unresectable or metastatic melanoma. In part 1, the recommended phase 3 regimen was identified based on the incidence of dose-limiting toxicities (DLTs; primary endpoint): 400 mg of spartalizumab every 4 weeks plus 150 mg of dabrafenib twice daily plus 2 mg of trametinib once daily. Part 2 characterized changes in PD-L1 levels and CD8 +  cells following treatment (primary endpoint), and analyzed additional biomarkers. Assessments of efficacy and safety were key secondary endpoints (median follow-up, 24.3 months). Spartalizumab plus dabrafenib and trametinib led to an objective response rate (ORR) of 78%, including 44% complete responses (CRs). Grade ≥3 treatment-related adverse events (TRAEs) were experienced by 72% of patients. All patients had temporary dose modifications, and 17% permanently discontinued all three study drugs due to TRAEs. Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR. Overall, the efficacy, safety and on-treatment biomarker modulations associated with spartalizumab plus dabrafenib and trametinib are promising, and biomarkers that may predict long-term benefit were identified.",2020,Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR.,"['metastatic melanoma', 'Patients (n\u2009=\u200936) had previously untreated BRAF V600-mutant unresectable or metastatic melanoma', 'advanced BRAF-mutant melanoma']","['spartalizumab every 4\u2009weeks plus 150\u2009mg of dabrafenib twice daily plus 2\u2009mg of trametinib once daily', 'anti-PD-1 antibody spartalizumab, in combination with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib', 'placebo']","['objective response rate (ORR', 'PD-L1 levels and CD8 +  cells', 'efficacy and safety', 'efficacy, safety', 'Grade\u2009≥3 treatment-related adverse events (TRAEs', 'Early progression-free survival (PFS) events']","[{'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3838813', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.208807,Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR.,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zurich, Switzerland. Reinhard.Dummer@usz.ch.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Hôpital Saint-Louis, Dermatology and CIC, Université de Paris, Paris, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Greenslopes Private Hospital, Gallipoli Medical Research Foundation, University of Queensland, Greenslopes, Queensland, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Richtig', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Tawbi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': ""Istituto Nazionale Tumori IRCCS Fondazione 'G. Pascale', Naples, Italy.""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pakhle', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Catarina D', 'Initials': 'CD', 'LastName': 'Campbell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Masood', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.'}]",Nature medicine,['10.1038/s41591-020-1082-2']
2524,33020691,Effects of the blended learning model on preservice teachers' academic achievements and twenty-first century skills.,"The purpose of this study was to examine the effects of a blended teaching-learning approach on academic achievement and twenty-first century skills of preservice teachers who took the teaching principles and methods course. The implementation was carried out over a period of ten weeks with preservice teachers who were enrolled in pedagogical training at the Faculty of Education at Karamanoğlu Mehmetbey University in the 2019-2020 academic year. In the study, a semi-experimental research design with experimental and control groups was employed. Data collection tools were an academic achievement test and ""multidimensional twenty-first century skills scale"". Analysis revealed that there was a significant difference across the two groups' academic achievement and twenty-first century skills in favor of the experimental group. In addition, analysis of the retention test administered four weeks later showed a significant difference in favor of the experimental group. In the light of the results, the implications and future directions were discussed.",2020,Analysis revealed that there was a significant difference across the two groups' academic achievement and twenty-first century skills in favor of the experimental group.,"[""preservice teachers' academic achievements and twenty-first century skills"", 'ten weeks with preservice teachers who were enrolled in pedagogical training at the Faculty of Education at Karamanoğlu Mehmetbey University in the 2019-2020 academic year', 'academic achievement and twenty-first century skills of preservice teachers who took the teaching principles and methods course']","['blended teaching-learning approach', 'blended learning model']",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],,0.0174311,Analysis revealed that there was a significant difference across the two groups' academic achievement and twenty-first century skills in favor of the experimental group.,"[{'ForeName': 'Cihad', 'Initials': 'C', 'LastName': 'Şentürk', 'Affiliation': 'Faculty of Education, Karamanoğlu Mehmetbey University, Karaman, Turkey.'}]",Education and information technologies,['10.1007/s10639-020-10340-y']
2525,33020726,Behavioral changes in patients with diabetes during the COVID-19 pandemic.,"Aims/Introduction


Amid the coronavirus disease (COVID-19) pandemic, the Japanese government declared a state of emergency and urged people to stay at home to prevent disease transmission. Herein, we investigated this emergency situation's effect on diabetes patients' lifestyle and glycemic control.
Materials and methods


Diabetes patients who visited our hospital between April 1 and June 13, 2020, for a regular consultation were asked about changes in their physical activities and dietary habits during the state of emergency period.
Results


Among 168 patients, 26 (15.5%) gained > 2 kg; HbA1c levels were elevated or decreased by > 0.2% compared to that at the last visit in 57 and 51 patients (Groups D and I), respectively. Group D patients were affected to a larger extent by changes in commuting (transition to teleworking) and closures of sport gyms than Group I patients. Increased snacks, sweets, total diet, and alcohol intake could have contributed to worsening of glucose control in Group D, whereas a healthy diet and less alcohol intake could have led to better glucose control in Group I.
Conclusion


During the state of emergency period, decreased physical activity levels negatively affected glycemic control. However, despite changes in physical activity level, maintaining or improving dietary habits could lead to better glycemic control in diabetes patients. During this COVID-19 pandemic, more diabetes patients are likely to shift to teleworking and stay home for longer periods. Therefore, we should develop effective and feasible measures to promote exercise and dietary therapy, especially for those who engage in teleworking.",2020,Group D patients were affected to a larger extent by changes in commuting (transition to teleworking) and closures of sport gyms than Group I patients.,"['Diabetes patients who visited our hospital between April 1 and June 13, 2020, for a regular consultation were asked about changes in their physical activities and dietary habits during the state of emergency period', ""diabetes patients' lifestyle and glycemic control"", 'patients with diabetes during the COVID-19 pandemic', 'diabetes patients']",[],"['Behavioral changes', 'physical activity level, maintaining or improving dietary habits', 'Increased snacks, sweets, total diet, and alcohol intake', 'physical activity levels']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],"[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0115511,Group D patients were affected to a larger extent by changes in commuting (transition to teleworking) and closures of sport gyms than Group I patients.,"[{'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Clinical Research Center, Department of Medicine, International University of Health and Welfare, 8-10-16 Akasaka Minato, Tokyo, 107-0052 Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Internal Medicine, Sanno Hospital, 8-10-16 Akasaka Minato, Tokyo, 107-0052 Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Odawara', 'Affiliation': 'Clinical Research Center, Department of Medicine, International University of Health and Welfare, 8-10-16 Akasaka Minato, Tokyo, 107-0052 Japan.'}]",Diabetology international,['10.1007/s13340-020-00467-1']
2526,33020803,Music Stimuli for Mindfulness Practice: A Replication Study.,"Mindfulness is a natural human capacity to be aware of the present moment, without judgment, rejection, or attachment to it. Cultivating a mindful state has been related to improvements in mood and stress management. Mindfulness practices may be enhanced with music. The purpose of this study was to replicate a previous study regarding the effectiveness, preference, and usefulness of different auditory stimuli for mindfulness practice. Undergraduate nonmusicians (N = 53) listened to 4 different auditory stimuli of increasing complexity, guiding them in a mindfulness experience. Participants rated their mindfulness experience, provided data on their absorption in music, and ranked auditory stimuli according to preference and usefulness for mindfulness practice. A within-subjects design was used to compare the four conditions, counterbalanced, and randomized across participants. Similar to the original study, Friedman analysis of variances (ANOVAs) and post hoc analyses indicated that participants ranked the Melody and Harmony conditions as most preferred and useful. Different from the original results, the repeated-measures ANOVA of the Mindful Attention Awareness Scale scores did not reveal significant differences among auditory stimuli for mindfulness experience. These results provide support for the use of music in mindfulness experiences with a mildly complex stimulus (script, beat, harmony, and melody). However, partially replicated results indicate the need to investigate the discrepancy between participants' effectiveness ratings and preference/usefulness rankings.",2020,"Different from the original results, the repeated-measures ANOVA of the Mindful Attention Awareness Scale scores did not reveal significant differences among auditory stimuli for mindfulness experience.",['Mindfulness Practice'],"['Undergraduate nonmusicians (N = 53) listened to 4 different auditory stimuli of increasing complexity, guiding them in a mindfulness experience']",['Mindful Attention Awareness Scale scores'],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",53.0,0.0236264,"Different from the original results, the repeated-measures ANOVA of the Mindful Attention Awareness Scale scores did not reveal significant differences among auditory stimuli for mindfulness experience.","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Hernandez-Ruiz', 'Affiliation': 'Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Abbey L', 'Initials': 'AL', 'LastName': 'Dvorak', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",Journal of music therapy,['10.1093/jmt/thaa018']
2527,33002633,IL-8 and CRP moderate the effects of preoperative psychological interventions on postoperative long-term outcomes 6 months after CABG surgery - The randomized controlled PSY-HEART trial.,"INTRODUCTION


Inflammation has been related to several somatic and psychological disorders and may moderate effects of psychological interventions. In the PSY-HEART trial patients benefitted from preoperative psychological interventions before undergoing coronary artery bypass graft surgery (CABG) and, if necessary, concomitant valvular surgery, compared to standard medical care. In this study we examined whether patients' baseline inflammatory status moderated the intervention effects.
MATERIAL AND METHODS


In a prospective three-arm randomized clinical trial with 6-months follow-up, 124 patients scheduled for CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT). Available baseline CRP- (n = 79), IL-6- (n = 78), IL-8- (n = 78) and TNF-alpha-(n = 80) parameters were considered as potential moderators (CRP as a categorical and continuous moderator). Linear mixed model analyses were calculated to test whether baseline inflammatory levels moderated intervention effects on disability, mental and physical quality of life at 6 months after surgery.
RESULTS


IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life. Follow-up tests indicated that EXPECT (and in part SUPPORT) led to lower postoperative disability and higher mental quality of life compared to SMC in patients with low baseline inflammatory markers. EXPECT indicated higher mental quality of life compared to SUPPORT in the high CRP subgroup. Patients in the SMC group had higher mental quality of life in the high CRP subgroup compared to the low CRP subgroup.
CONCLUSION


Especially for patients with a lower inflammatory baseline status preoperative psychological interventions might be helpful to optimize long-term CABG surgery outcomes.",2020,"RESULTS


IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life.","['patients with a lower inflammatory baseline status', '124 patients scheduled for']","['coronary artery bypass graft surgery (CABG', 'CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT', 'preoperative psychological interventions', 'EXPECT']","['mental quality of life', 'disability, mental and physical quality of life', 'postoperative disability and higher mental quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205250', 'cui_str': 'High'}]",124.0,0.0625414,"RESULTS


IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Salzmann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany. Electronic address: stefan.salzmann@staff.uni-marburg.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Euteneuer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany; Clinical Psychology and Psychotherapy, Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Johannes A C', 'Initials': 'JAC', 'LastName': 'Laferton', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany; Department of Clinical Psychology and Psychotherapy, Psychologische Hochschule Berlin, Berlin, Germany.'}, {'ForeName': 'Meike C', 'Initials': 'MC', 'LastName': 'Shedden-Mora', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Clinic Essen, Essen, Germany; Department of Clinical Neuroscience, Osher Center for Integrative Medicine, Karolinska Institute, 17177 Stockholm, Sweden.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Moosdorf', 'Affiliation': 'Department for Cardiovascular Surgery, Heart Center, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.09.028']
2528,33002644,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,,2020,,['Dementia with Lewy Bodies'],['Bilateral Nucleus Basalis of Meynert D Brain Stimulation'],[],"[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}]",[],,0.259573,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Weihai Municipal Hospital, Cheeloo College of Medicine, Shandong University, No.70, Heping Road, Weihai, Shandong, China, 264200. Electronic address: liuwei881x@outlook.com.'}, {'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Yu', 'Affiliation': 'Weihai Municipal Third Hospital, Weihai, Shandong, China, 264205. Electronic address: yudongyan@outlook.com.'}]",Brain stimulation,['10.1016/j.brs.2020.09.020']
2529,33002645,Enhancing cognitive training effects in Alzheimer's disease: rTMS as an add-on treatment.,"The treatment of Alzheimer's disease (AD) in the field of non-pharmacological interventions is a challenging issue, given the limited benefits of the available drugs. Cognitive training (CT) represents a commonly recommended strategy in AD. Recently, repetitive transcranial magnetic stimulation (rTMS) has gained increasing attention as a promising therapeutic tool for the treatment of AD, given its ability of enhancing neuroplasticity. In the present randomized, double-blind, sham-controlled study, we aimed at investigating the add-on effect of a high frequency rTMS protocol applied over the left dorsolateral prefrontal cortex (DLPFC) combined with a face-name associative memory CT in the continuum of AD pathology. Fifty patients from a very early to a moderate phase of dementia were randomly assigned to one of two groups: CT plus real rTMS or CT plus placebo rTMS. The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone. Interestingly, the extent of the additional improvement was affected by disease severity and levels of education, with less impaired and more educated patients showing a greater benefit. When testing for generalization to non-trained cognitive functions, results indicated that patients in CT-real group showed also a greater improvement in visuospatial reasoning than those in the CT-sham group. Interestingly, this improvement persisted over 12 weeks after treatment beginning. The present study provides important hints on the promising therapeutic use of rTMS in AD.",2020,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"['Fifty patients from a very early to a moderate phase of dementia', ""Alzheimer's disease""]","['rTMS', 'CT plus real rTMS or CT plus placebo rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Cognitive training (CT']","['visuospatial reasoning', 'disease severity and levels of education', 'trained associative memory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",50.0,0.0608235,The results showed that the improvement in the trained associative memory induced with rTMS was superior to that obtained with CT alone.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bagattini', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. Electronic address: chiara.bagattini@cognitiveneuroscience.it.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Zanni', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barocco', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caffarra', 'Affiliation': 'Department of Medicine and Surgery, Section of Neuroscience, University of Parma, 43126, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Brignani', 'Affiliation': 'Cognitive Neuroscience Section, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Miniussi', 'Affiliation': 'Center for Mind/Brain Sciences- CIMeC, University of Trento, 38068, Rovereto, Italy.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Defanti', 'Affiliation': ""Fondazione Europea Ricerca Biomedica, Ospedale Sant'Isidoro, 24069, Trescore Balneario, Bergamo, Italy.""}]",Brain stimulation,['10.1016/j.brs.2020.09.010']
2530,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND


Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD


Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS


One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION


To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
2531,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
2532,33004727,Tobacco cessation effects on oral health by group and individualized motivational therapy in 12 to 18 years old boys - A randomized controlled study.,"Background/Introduction


Adolescents are the most vulnerable population to initiate tobacco use. It is now well established that most of the adult users of tobacco start tobacco use in their childhood or adolescence.
Aim


The purpose of this study is to compare and evaluate the Group Motivational Therapy (GMT) and Individualised Motivational therapy (IMT) for tobacco cessation in adolescents.
Methodology


Oral screening was done in a village named Vehra Khadi near Anand. One hundred and eight adolescents aged between 12 and 18 years were included in the study. They were randomly divided into three groups namely Group 1 - Interventional group consisting of 36 adolescents who were given GMT; Group 2 - Interventional group consisting of 36 adolescents who were given IMT; and Group 3 -3 6 age - matched Negative control group. Hence, a total sample size of 108 was evaluated for tobacco consumption frequency, passive smoking, gingival index, and stain index and followed up for 9 months for the effect of both interventional group as well as positive control.
Results


Frequency of tobacco consumption was reduced from baseline to 9 months' follow-up for both the interventional groups, which was statistically significant with <0.001 percent P value showing 84.38% change by intervention 1 and 98.30% in intervention 2.
Conclusion


Group and individualized motivation serves as an effective means for tobacco cessation among adolescents. Improvement in gingival health and reduction of the tobacco consumption was observed with motivational intervention.",2020,"Results


Frequency of tobacco consumption was reduced from baseline to 9 months' follow-up for both the interventional groups, which was statistically significant with <0.001 percent P value showing 84.38% change by intervention 1 and 98.30% in intervention 2.
","['12 to 18 years old boys ', 'adolescents', 'One hundred and eight adolescents aged between 12 and 18 years were included in the study', '36 adolescents who were given']","['Group Motivational Therapy (GMT) and Individualised Motivational therapy (IMT', 'oral health by group and individualized motivational therapy', 'IMT', '36 adolescents who were given GMT']","['gingival health and reduction of the tobacco consumption', 'tobacco consumption frequency, passive smoking, gingival index, and stain index', 'Frequency of tobacco consumption']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",108.0,0.0461107,"Results


Frequency of tobacco consumption was reduced from baseline to 9 months' follow-up for both the interventional groups, which was statistically significant with <0.001 percent P value showing 84.38% change by intervention 1 and 98.30% in intervention 2.
","[{'ForeName': 'Kinjal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India.'}, {'ForeName': 'Anshula', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Shah', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India.'}, {'ForeName': 'Pulkit', 'Initials': 'P', 'LastName': 'Kalyan', 'Affiliation': 'Department of Public Health Dentistry, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India.'}]",Journal of the Indian Society of Pedodontics and Preventive Dentistry,['10.4103/JISPPD.JISPPD_333_20']
2533,33007031,Oral intake of mesoporous silica is safe and well tolerated in male humans.,"BACKGROUND


Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated.
OBJECTIVE


The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.
DESIGN


This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).
RESULTS


All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
CONCLUSION


Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.",2020,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","['male humans', 'Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2', '10 males each (18-35 years', 'participants with normal weight and one with obesity']",['placebo'],"['weight loss', 'Mesoporous silica intake', 'abdominal discomfort, and changes in bowel habits']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0278008', 'cui_str': 'Altered bowel function'}]",,0.0774239,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Elimam', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kupferschmidt', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ekbom', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rössner', 'Affiliation': 'Apple Bay Obesity Research Centre, Bromma, Sweden.'}, {'ForeName': 'Muhammad Naeem', 'Initials': 'MN', 'LastName': 'Iqbal', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindgren', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240030']
2534,33007041,Generation of a malaria negative Ugandan birth weight standard for the diagnosis of small for gestational age.,"OBJECTIVE


Placental malaria is a known risk factor for small for gestational age (SGA) neonates. However, currently utilized international and African birthweight standards have not controlled for placental malaria and/or lack obstetrical ultrasound dating. We developed a neonatal birthweight standard based on obstetrically dated pregnancies that excluded individuals with clinical malaria, asymptomatic parasitemia, and placental malaria infection. We hypothesized that current curves underestimate true ideal birthweight and the prevalence of SGA.
STUDY DESIGN


Participants were pooled from two double-blind randomized control trials of intermittent preventive therapy during pregnancy in Uganda. HIV-negative women without comorbidities were enrolled from 12-20 weeks gestation. Gestational age was confirmed by ultrasound dating. Women were followed through pregnancy and delivery for clinical malaria, asymptomatic parasitemia, and placental malaria. Women without malaria, asymptomatic parasitemia, or placental malaria formed the malaria negative cohort and generated the Ugandan birthweight standard. The Ugandan standard was then used to estimate the prevalence of SGA neonates in the malaria positive cohort. These findings were compared to international (Williams, World Health Organization (WHO), and INTERGROWTH-21st) and regional standards (Tanzanian and Malawi).
RESULTS


926 women had complete delivery data; 393 (42.4%) met criteria for the malaria negative cohort and 533 (57.6%) were malaria positive. The Ugandan standard diagnosed SGA in 17.1% of malaria positive neonates; similar to the INTERGROWTH-21st and Schmiegelow curves. The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
CONCLUSION


Exclusion of women with subclinical placental malaria in malaria-endemic areas created birth weight norms at higher values and increased the detection of SGA. Birth weight standards that fail to account for endemic illness may underestimate the true growth potential of healthy neonates.",2020,"The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
","['individuals with clinical malaria, asymptomatic parasitemia, and placental malaria infection', 'Women without malaria, asymptomatic parasitemia, or placental malaria formed the malaria negative cohort and generated the Ugandan birthweight standard', '926 women had complete delivery data; 393 (42.4%) met criteria for the malaria negative cohort and 533 (57.6%) were malaria positive', 'Participants', 'HIV-negative women without comorbidities were enrolled from 12-20 weeks gestation', 'small for gestational age (SGA) neonates', 'healthy neonates']",['intermittent preventive therapy'],"['malaria negative', 'detection of SGA', 'Malawi curve diagnosed SGA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",926.0,0.292602,"The WHO curve diagnosed SGA in significantly more neonates (32.1%, p = <0.001), and the Malawi curve diagnosed SGA in significantly fewer neonates (8.3%, p <0.001).
","[{'ForeName': 'Arthurine K', 'Initials': 'AK', 'LastName': 'Zakama', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Terik', 'Initials': 'T', 'LastName': 'Weekes', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Gaw', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0240157']
2535,33007285,Intravenous versus oral antibiotics for eradication of Pseudomonas aeruginosa in cystic fibrosis (TORPEDO-CF): a randomised controlled trial.,"BACKGROUND


Chronic pulmonary infection with Pseudomonas aeruginosa is one of the most important causes of mortality and morbidity in cystic fibrosis. If antibiotics are commenced promptly, infection can be eradicated. The aim of the trial was to compare the effectiveness and safety of intravenous ceftazidime and tobramycin versus oral ciprofloxacin in the eradication of P aeruginosa.
METHODS


We did a multicentre, parallel group, open-label, randomised controlled trial in 72 cystic fibrosis centres (70 in the UK and two in Italy). Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection). Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding. We used web-based randomisation to assign patients to 14 days intravenous ceftazidime and tobramycin or 12 weeks oral ciprofloxacin. Both were combined with 12 weeks inhaled colistimethate sodium. Randomisation lists were generated by a statistician, who had no involvement in the trial, using a computer-generated list. Randomisation was stratified by centre and because of the nature of the interventions, blinding was not possible. Our primary outcome was eradication of P aeruginosa at 3 months and remaining free of infection to 15 months. Primary analysis used intention to treat (powered for superiority). Safety analysis included patients who received at least one dose of study drug. TORPEDO-CF was registered on the ISRCTN register, ISRCTN02734162, and EudraCT, 2009-012575-10.
FINDINGS


Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment: 137 to intravenous antibiotics and 149 to oral antibiotics. 55 (44%) of 125 participants in the intravenous group and 68 (52%) of 130 participants in the oral group achieved the primary outcome. Participants randomly assigned to the intravenous group were less likely to achieve the primary outcome, although the difference between groups was not statistically significant (relative risk 0·84, 95% CI 0·65-1·09; p=0·18). 11 serious adverse events occurred in ten (8%) of 126 participants in the intravenous antibiotics group and 17 serious adverse events in 12 (8%) of 146 participants in the oral antibiotics group.
INTERPRETATION


Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive. Although there were fewer hospitalisations in the intravenous group than the oral group during follow-up, this confers no advantage over oral treatment because intravenous eradication frequently requires hospitalisation. These results do not support the use of intravenous antibiotics to eradicate P aeruginosa in cystic fibrosis.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","['Between Oct 5, 2010, and Jan 27, 2017, 286 patients were randomly assigned to treatment', 'cystic fibrosis', 'Participants were excluded if the P aeruginosa was resistant to, or they had a contraindication to, one or more of the trial antibiotics; if they were already receiving P aeruginosa suppressive therapy; if they had received any P aeruginosa eradication therapy within the previous 9 months; or if they were pregnant or breastfeeding', 'patients who received at least one dose of study drug', '72 cystic fibrosis centres (70 in the UK and two in Italy', 'Eligible participants were older than 28 days with an isolate of P aeruginosa (either the first ever isolate or a new isolate after at least 1 year free of infection', 'cystic fibrosis (TORPEDO-CF']","['ciprofloxacin', 'ceftazidime and tobramycin', 'oral antibiotics', 'inhaled colistimethate sodium']","['serious adverse events', 'effectiveness and safety', '11 serious adverse events', 'eradication of P aeruginosa']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040478', 'cui_str': 'Torpedo'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0110462', 'cui_str': 'Colistimethate sodium'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]",72.0,0.164174,"Compared with oral therapy, intravenous antibiotics did not achieve sustained eradication of P aeruginosa in a greater proportion of patients with cystic fibrosis and was more expensive.","[{'ForeName': 'Simon C Langton', 'Initials': 'SCL', 'LastName': 'Hewer', 'Affiliation': 'Department of Paediatric Respiratory Medicine, Bristol Royal Hospital for Children, University of Bristol, Bristol, UK. Electronic address: UKsimon.langtonhewer@bristol.ac.uk.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Dervla', 'Initials': 'D', 'LastName': 'Kenna', 'Affiliation': 'Antimicrobial Resistance and Healthcare Associated Infections Reference Unit, National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ashby', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'The University of Manchester, Manchester Centre for Health Economics, Manchester, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30331-3']
2536,33008855,"Integrating Calcium Into Antenatal Iron-Folic Acid Supplementation in Ethiopia: Women's Experiences, Perceptions of Acceptability, and Strategies to Support Calcium Supplement Adherence.","Recommendations for antenatal calcium supplementation to prevent preeclampsia could substantially reduce maternal mortality, but adherence to multiple daily doses may constrain effectiveness. World Health Organization guidelines recommend 3 daily calcium supplements (1.5-2 g/d), taken separately from 1 iron-folic acid (IFA) supplement; however, limited data suggest lower calcium doses may also be effective. We conducted mixed-methods household trials to identify strategies for supporting adherence and integrating calcium into antenatal IFA supplementation programming in Ethiopia. Participants were randomly assigned to 3 regimens varying in dose and timing and were later given a choice of regimens. Semistructured interviews conducted over 6 weeks explored acceptability, barriers, and facilitators and offered opportunities to choose calcium pill type. Interviews were transcribed, translated, and analyzed thematically. Calcium adherence was measured using medication event monitoring. All participants (N=48) agreed to try supplementation. Adherence barriers included forgetting to take pills when busy or travelling and perceived side effects. Midday doses were the most challenging because of farming, market, and social events; women avoided taking supplements in public due to fear of being perceived as HIV positive. Social support from families, visual reminders, and anticipated benefits motivated adherence. More participants (75%) selected chewable versus conventional supplements due to organoleptic properties, but this preference declined over time. Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events. Women indicated that the 2-event regimen was more acceptable than 3- and 4-event regimens, but this acceptability was not associated with higher adherence. Consequently, mean daily calcium consumption (811.3 mg) was lower than for 3-event (1,251.1 mg) and 4-event (1,156.4 mg) regimens. Integrating calcium into antenatal IFA supplementation is acceptable to Ethiopian women, with a 3-event regimen yielding the highest consumption rates. Despite women experiencing challenges with midday dosing and stigma, using simple home-based strategies and being counseled on the purpose of supplementation were more effective than reducing dosage for mitigating barriers and improving adherence.",2020,"Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events.","['All participants (N=48) agreed to try supplementation', 'Ethiopia']",['Integrating Calcium Into Antenatal Iron-Folic Acid Supplementation'],"['Calcium adherence', 'Adherence rates', 'mean daily calcium consumption', 'maternal mortality']","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}]",,0.0597183,"Adherence rates did not substantially differ across regimens with 2 (81.1%), 3 (83.4%), or 4 (77.1%) pill-taking events.","[{'ForeName': 'Gina C', 'Initials': 'GC', 'LastName': 'Klemm', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Zewdie', 'Initials': 'Z', 'LastName': 'Birhanu', 'Affiliation': 'Faculty of Public Health, Department of Health, Behavior and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Ortolano', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Yohannes', 'Initials': 'Y', 'LastName': 'Kebede', 'Affiliation': 'Faculty of Public Health, Department of Health, Behavior and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Martin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Girma', 'Initials': 'G', 'LastName': 'Mamo', 'Affiliation': 'Ethiopia-Canada Cooperation Office, Nutrition International, Addis Ababa, Ethiopia.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Dickin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA. kld12@cornell.edu.'}]","Global health, science and practice",['10.9745/GHSP-D-20-00008']
2537,33009241,"Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.","BACKGROUND


To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80 mg with valsartan 160 mg monotherapy for efficacy and safety in hypertensive patients.
METHODS


We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80 mg FDC or valsartan 160 mg monotherapy for 8 weeks. The primary endpoint was changes in office SBP and DBP from baseline to 8 weeks. Twenty-four-hour blood pressure (BP) and the incidence of adverse events were recorded.
RESULTS


A total of 42 patients underwent randomization. At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively. The between-group differences were -9.6 mmHg (95% CI, -18.1 to -1.1; p = 0.028) for SBP and -7.3 mmHg (95% CI, -11.8 to -2.8; p = 0.002) for DBP. Furthermore, reductions in both 24-hour SBP (-9.2 mmHg; 95% CI, -16.4 to -2.1; p = 0.013) and DBP (-4.6 mmHg; 95% CI, -9.2 to -0.1; p = 0.048) were consistently greater with amlodipine/valsartan 5/80 mg FDC than with valsartan 160 mg. Overall, 27 and 23 adverse events occurred in the amlodipine/valsartan 5/80 mg FDC group and in the valsartan 160 mg monotherapy group, respectively. The majority were mild and were not related to study medications. There were no significant differences in safety between two treatments.
CONCLUSION


Efficacy of amlodipine/valsartan 5/80 mg FDC was superior to that of valsartan 160 mg monotherapy while both treatments were well-tolerated.",2020,"At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively.","['hypertension', '42 patients underwent randomization', 'patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP', 'hypertensive patients']","['valsartan 160\u2009mg monotherapy', 'amlodipine/valsartan 5/80\u2009mg FDC or valsartan 160\u2009mg monotherapy', 'amlodipine/valsartan', 'valsartan', 'FDC', 'Amlodipine/valsartan fixed-dose combination treatment']","['DBP', '24-hour SBP', 'blood pressure (BP) and the incidence of adverse events', 'efficacy and safety', 'office SBP and DBP', 'safety', 'office SBP changes', 'tolerated']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0991106', 'cui_str': 'valsartan 160 MG'}, {'cui': 'C1962523', 'cui_str': 'valsartan and amlodipine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",42.0,0.203794,"At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively.","[{'ForeName': 'Kang-Ling', 'Initials': 'KL', 'LastName': 'Wang', 'Affiliation': 'General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Yu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Tse-Min', 'Initials': 'TM', 'LastName': 'Lu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Lung-Ching', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Hsin-Bang', 'Initials': 'HB', 'LastName': 'Leu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000386']
2538,18150240,Trial of Local Treatment of Anal Pruritus With 3277 R. P.,,1949,,['Anal Pruritus With 3277 R. P'],[],[],"[{'cui': 'C0033775', 'cui_str': 'Pruritus ani'}]",[],[],,0.0201815,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'HILLEMAND', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'BENSAUDE', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'BORGIDA', 'Affiliation': ''}]",Bulletins et memoires de la Societe medicale des hopitaux de Paris,[]
2539,18127888,Therapy trial with paraaminosalicylic acid in chronic polyarthritis.,,1949,,['chronic polyarthritis'],['paraaminosalicylic acid'],[],"[{'cui': 'C1735378', 'cui_str': 'Chronic polyarthritis'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}]",[],,0.0164507,,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'LOVGREN', 'Affiliation': ''}]",Nordisk medicin,[]
2540,18128777,Comparative Study of Changes in Blood Coagulation in Subjects Undergoing Treatment With Salicylic Acid and Dicumarol.,,1949,,['Subjects Undergoing Treatment With'],['Salicylic Acid and Dicumarol'],[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0005640', 'cui_str': 'Dicumarol'}]",[],,0.0116107,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'PELLEGRINI', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'GHIRLANDA', 'Affiliation': ''}]",Il Progresso medico,[]
2541,18105172,How our blind (the blind in the blind home Bern) play theater.,,1948,,[],[],[],[],[],[],,0.0644905,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'SCHAFFER', 'Affiliation': ''}]",Pro Infirmis,[]
2542,18106360,Nasal diphtheria vaccination trial by instillation.,,1948,,[],[],[],[],[],[],,0.016931,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'SOMALOMA', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'DEL PUERTO', 'Affiliation': ''}]",El Dia medico,[]
2543,33010470,Effectiveness of Modalities to Teach Evidence Based Medicine to Pediatric Clerkship Students: a Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effectiveness of a traditional didactic session (TDS) as compared to a self-paced, interactive, multimedia module (SPM) on the application of evidence-based medicine (EBM) skills among medical students during their inpatient pediatric rotation.
METHODS


We conducted a randomized controlled trial from 6/2017 to 6/2018 at a quaternary care children's hospital. Students were randomized to TDS or SPM during each 2-week block. All students completed a critical appraisal tool (CAT) of evidence related to a clinical question in a standardized appraisal form and self-reflected about the EBM process. The primary outcome was the numeric score of the CAT derived by using the validated Fresno tool. Secondary outcomes of knowledge, attitudes, confidence, and self-reported behaviors related to EBM were measured using validated surveys. Statistical analysis was performed using student's t-test for CAT scores and mixed-model procedure (PROC MIXED), with subject as random effect and time as repeated measure for the secondary outcomes.
RESULTS


127 clerkship students were included. Overall, there was no significant difference in mean CAT scores for TDS (n=59) versus SPM (n=66) groups (90.3 vs. 92.0, p=0.65). There were no significant differences between SPM and TDS groups for knowledge (p=0.66), attitudes (p=0.97), confidence (p=0.55), and accessing evidence (p=0.27). Both groups showed significant gains in knowledge, attitudes, confidence, and accessing evidence from baseline to post course. Improvements in knowledge and confidence were sustained at 3-months.
CONCLUSION


A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.",2020,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"['Pediatric Clerkship Students', ""6/2017 to 6/2018 at a quaternary care children's hospital"", 'medical students during their inpatient pediatric rotation', '127 clerkship students']","['SPM', 'traditional didactic session (TDS', 'TDS', 'self-paced, interactive, multimedia module (SPM', 'TDS or SPM']","['knowledge, attitudes, confidence, and accessing evidence', 'knowledge, attitudes, confidence, and self-reported behaviors related to EBM', 'mean CAT scores', 'numeric score of the CAT']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.166549,A SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.,"[{'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Hadvani', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: tshadvan@texaschildrens.org.'}, {'ForeName': 'Ankhi', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Section of Pediatric Infectious Diseases, Department of Pediatrics, Baylor College of Medicine; 17580 I-45 South, WM 560, The Woodlands, Texas 77384. Electronic address: axdutta@texaschildrens.org.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: exchoy@texaschildrens.org.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Center of Research, Innovation, and Scholarship for Medical Education, Department of Pediatrics, Baylor College of Medicine/Texas Children's Hospital; 6621 Fannin St Suite A118, Houston, TX 77030. Electronic address: sxkumar3@texaschildrens.org.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Molleda', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: icmolled@texaschildrens.org.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Parikh', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: vjparikh@texaschildrens.org.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Lopez', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: malopez@texaschildrens.org.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lui', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: klui@bcm.edu.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ban', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: keban@texaschildrens.org.'}, {'ForeName': 'Sowdhamini S', 'Initials': 'SS', 'LastName': 'Wallace', 'Affiliation': 'Section of Pediatric Hospital Medicine, Department of Pediatrics, Baylor College of Medicine; 1102 Bates Ave FC 1860, Houston, Texas 77030. Electronic address: sswallac@texaschildrens.org.'}]",Academic pediatrics,['10.1016/j.acap.2020.09.012']
2544,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION


Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS


In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS


Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS


Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
2545,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE


To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA


A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN


A historical cohort.
SETTING


Postoperative period.
PATIENTS


Opioid-naive U.S. veterans.
INTERVENTIONS


The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS


The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS


A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS


Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
2546,33010590,Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects.,"Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population. Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe. The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1 (p<.001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01). In this study the differences between different forefoot offloading shoes was assessed. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.",2020,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","['Twenty subjects walked', 'healthy adult subjects']",[],"['Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes', 'Plantar pressure distribution and wearing characteristics', 'Peak pressure and pressure time integral', 'peak pressure reduction', 'peak pressure']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0330946,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","[{'ForeName': 'M C H W', 'Initials': 'MCHW', 'LastName': 'Fuchs', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands. Electronic address: thijn.fuchs@catharinaziekenhuis.nl.'}, {'ForeName': 'M M N', 'Initials': 'MMN', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'H J J', 'Initials': 'HJJ', 'LastName': 'Kars', 'Affiliation': 'Fontys Hogeschool Eindhoven, Allied Health Professions, Dominee Theodor Fliednerstraat 2, 5631 BN Eindhoven, The Netherlands.'}, {'ForeName': 'J G E', 'Initials': 'JGE', 'LastName': 'Hendriks', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101744']
2547,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE


In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS


This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS


At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION


This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
2548,33017120,Randomized Control Trial on the Effectiveness of Collagen Cross-linking on Bullous Keratopathy.,"PURPOSE


To investigate the long-term effect and safety of collagen cross-linking (CXL) on patients with bullous keratopathy (BK) in a randomized control manner. It is, to our knowledge, the first randomized control study on the effect of CXL on BK.
METHODS


Subjects were randomized to receive CXL as in the standard protocol for treating keratoconus or a placebo treatment. Subjects were assessed at baseline and up to 12 months after treatment. Primary outcomes were central corneal thickness (CCT) and pain scores.
RESULTS


Forty-two patients with BK participated in the study treatment, 26 subjects were randomized to the CXL group and 16 subjects to the control group. The reduction of CCT in the CXL group was 37.6 and 63.8 μm at 2 and 4 weeks, respectively, which were significantly higher than that in the control group. However, there was no statistical difference in CCT reduction between the 2 groups at 12 weeks and after. There were no consistent advantages in pain score, corneal clarity, and visual acuity over the controls throughout the 1-year follow-up. However, CXL was associated with more recurrent epithelial defect (12%), and 2 of the 3 subjects with epithelial defect required amniotic membrane transplant.
CONCLUSIONS


CXL reduced corneal thickness in the patients with BK, at least for the initial period. However, there were no improvement in pain, corneal clarity, and vision that were of more clinical relevance to the patients. Its short-term benefit was unlikely to outweigh its potential risk of recurrent epithelial defect.",2020,"There were no consistent advantages in pain score, corneal clarity, and visual acuity over the controls throughout the 1-year follow-up.","['Forty-two patients with BK participated in the study treatment, 26 subjects', 'patients with bullous keratopathy (BK', 'Bullous Keratopathy', 'Subjects']","['placebo treatment', 'Collagen Cross-linking', 'collagen cross-linking (CXL', 'CXL']","['CCT reduction', 'pain score, corneal clarity, and visual acuity', 'central corneal thickness (CCT) and pain scores', 'corneal thickness', 'reduction of CCT', 'pain, corneal clarity, and vision', 'recurrent epithelial defect']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155111', 'cui_str': 'Bullous keratopathy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",42.0,0.0437649,"There were no consistent advantages in pain score, corneal clarity, and visual acuity over the controls throughout the 1-year follow-up.","[{'ForeName': 'Bonnie Nga Kwan', 'Initials': 'BNK', 'LastName': 'Choy', 'Affiliation': '*Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong; and †Department of Applied Mathematics, Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Alex Lap Ki', 'Initials': 'ALK', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Ming Ming', 'Initials': 'MM', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Catherine Chunling', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Jimmy Shiu Ming', 'Initials': 'JSM', 'LastName': 'Lai', 'Affiliation': ''}]",Cornea,['10.1097/ICO.0000000000002395']
2549,33017169,A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial.,"BACKGROUND


The anteromedial (AM) portal and transtibial (TT) approaches are 2 common anterior cruciate ligament (ACL) femoral tunnel drilling techniques, each with unique benefits and disadvantages. A hybrid TT (HTT) technique using medial portal guidance of a flexible TT guide wire has recently been described that may combine the strengths of both the AM portal and the TT approaches.
HYPOTHESIS


The HTT technique will achieve anatomic femoral tunnel apertures similar to the AM portal technique, with improved femoral tunnel length and orientation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 30 consecutive patients with primary ACL tears were randomized to undergo the TT, AM portal, or HTT technique for femoral tunnel positioning at the time of reconstruction. All patients underwent 3-dimensional computed tomography of the operative knee at 6 weeks postoperatively. Femoral and tibial tunnel aperture positions and tunnel lengths, as well as graft bending angles in the sagittal and coronal planes, were measured.
RESULTS


Tibial tunnel lengths and aperture positions were identical between the 3 groups. The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582). By contrast, compared with the AM portal and HTT techniques, femoral apertures created with the TT technique were significantly higher ( P  < .001 and  P  < .001, respectively) and shallower ( P  = .014 and  P  = .022, respectively) in the notch. The mean femoral tunnel length varied significantly between the groups, measuring 35.2, 41.6, and 54.1 mm for the AM portal, HTT, and TT groups, respectively ( P  < .001). Last, there was no difference between the mean coronal ( P  = .190) and sagittal ( P  = .358) graft bending angles between the TT and HTT groups. By contrast, compared with the TT and HTT techniques, femoral tunnels created with the AM portal technique were significantly more angulated in the coronal plane (17.7° [ P  < .001] and 12.5° [ P  = .006], respectively) and sagittal plane (13.5° [ P  < .001] and 10.5° [ P  = .013], respectively).
CONCLUSION


This prospective randomized controlled trial found that the HTT technique achieved femoral aperture positions equally as anatomic as the AM portal technique but produced longer, less angulated femoral tunnels, which may help reduce graft strain and mismatch. As such, this hybrid approach may represent a beneficial combination of both the TT and the AM portal techniques.
REGISTRATION


NCT02795247 (ClinicalTrials.gov identifier).",2020,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582).,['30 consecutive patients with primary ACL tears'],"['3-dimensional computed tomography', 'TT, AM portal, or HTT technique for femoral tunnel positioning', 'hybrid TT (HTT) technique', 'Anteromedial Portal and Transtibial Approaches']","['mean coronal', 'femoral tunnels created with the AM portal technique', 'Tibial tunnel lengths and aperture positions', 'sagittal plane', 'coronal plane', 'mean femoral tunnel length', 'Femoral and tibial tunnel aperture positions and tunnel lengths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C3266783', 'cui_str': 'Length of wound tunneling'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}]",30.0,0.0466478,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582).,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Trofa', 'Affiliation': 'Department of Orthopedics, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Saltzman', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Corpus', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Connor', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Fleischli', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Piasecki', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}]",The American journal of sports medicine,['10.1177/0363546520956645']
2550,33017172,"Relative Impact of Mindfulness, Self-Compassion, and Psychological Flexibility on Alcohol Use and Burnout Among Law Enforcement Officers.","Objectives:  In the present study, we investigated the relative impact of improvements in mindfulness, self-compassion, and psychological flexibility in predicting decreased burnout and alcohol use in a sample of law enforcement officers (LEOs) participating in a mindfulness-based intervention (MBI).  Design:  This study is a secondary analysis of pre/post data collected as part of a larger randomized controlled trial of mindfulness-based resilience training (MBRT).  Subjects:  This secondary analysis comprises pre/post data from 28 LEOs recruited from a metropolitan area and its outlying regions in the Pacific Northwest.  Intervention:  MBRT is a MBI tailored specifically to the culture and needs of LEOs and other first responders.  Outcome measures:  All included data were obtained through self-report measures. Mindfulness was assessed by the Five Facet Mindfulness Questionnaire-Short Form, self-compassion was assessed by the Self-Compassion Scale-Short Form, psychological flexibility was assessed by the Acceptance and Action Questionnaire-II, alcohol use was measured by the PROMIS ®  (v1.0) Alcohol Use-Short Form, and burnout was assessed by the Oldenburg Burnout Inventory.  Results:  In the first regression, only increases in mindfulness significantly predicted decreased postintervention problematic alcohol use. In the second regression, only increases in self-compassion significantly predicted decreased postintervention burnout.  Conclusions:  This study builds upon a growing body of literature on the relative impact of mindfulness, self-compassion, and psychological flexibility in predicting outcomes among high-stress cohorts. Results suggest that different components of MBIs may be emphasized to achieve unique benefits. The Clinical Trial Registration number for the parent study is NCT02521454.",2020,"In the first regression, only increases in mindfulness significantly predicted decreased postintervention problematic alcohol use.","['28 LEOs recruited from a metropolitan area and its outlying regions in the Pacific Northwest', 'Subjects']","['mindfulness-based resilience training (MBRT', 'MBRT']","['Relative Impact of Mindfulness, Self-Compassion, and Psychological Flexibility on Alcohol Use and Burnout', 'mindfulness, self-compassion, and psychological flexibility', 'postintervention problematic alcohol use', 'Self-Compassion Scale-Short Form, psychological flexibility', 'Five Facet Mindfulness Questionnaire-Short Form, self-compassion', 'Acceptance and Action Questionnaire-II, alcohol use', 'self-compassion']","[{'cui': 'C0524521', 'cui_str': 'Genus Panthera'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",28.0,0.0185295,"In the first regression, only increases in mindfulness significantly predicted decreased postintervention problematic alcohol use.","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Kaplan', 'Affiliation': 'School of Graduate Psychology, Pacific University, Forest Grove, OR, USA.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Bergman', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Kaylie', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'School of Graduate Psychology, Pacific University, Forest Grove, OR, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Dapolonia', 'Affiliation': 'School of Graduate Psychology, Pacific University, Forest Grove, OR, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christopher', 'Affiliation': 'School of Graduate Psychology, Pacific University, Forest Grove, OR, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0178']
2551,33017209,Long-Term Results of the RAPCO Trials.,"BACKGROUND


An internal thoracic artery graft to the left anterior descending artery is standard in coronary bypass surgery, but controversy exists on the best second conduit. The RAPCO trials (Radial Artery Patency and Clinical Outcomes) were designed to compare the long-term patency of the radial artery (RA) with that of the right internal thoracic artery (RITA) and the saphenous vein (SV).
METHODS


In RAPCO-RITA (the RITA versus RA arm of the RAPCO trial), 394 patients <70 years of age (or <60 years of age if they had diabetes mellitus) were randomized to receive RA or free RITA graft on the second most important coronary target. In RAPCO-SV (the SV versus RA arm of the RAPCO trial), 225 patients ≥70 years of age (or ≥60 years of age if they had diabetes mellitus) were randomized to receive RA or SV graft. The primary outcome was 10-year graft failure. Long-term mortality was a nonpowered coprimary end point. The main analysis was by intention to treat.
RESULTS


In the RA versus RITA comparison, the estimated 10-year patency was 89% for RA versus 80% for free RITA (hazard ratio for graft failure, 0.45 [95% CI, 0.23-0.88]). Ten-year patient survival estimate was 90.9% in the RA arm versus 83.7% in the RITA arm (hazard ratio for mortality, 0.53 [95% CI, 0.30-0.95]). In the RA versus SV comparison, the estimated 10-year patency was 85% for the RA versus 71% for the SV (hazard ratio for graft failure, 0.40 [95% CI, 0.15-1.00]), and 10-year patient survival estimate was 72.6% for the RA group versus 65.2% for the SV group (hazard ratio for mortality, 0.76 [95% CI, 0.47-1.22]).
CONCLUSIONS


The 10-year patency rate of the RA is significantly higher than that of the free RITA and better than that of the SV. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00475488.",2020,The 10-year patency rate of the RA is significantly higher than that of the free RITA and better than that of the SV.,"['225 patients ≥70 years of age (or ≥60 years of age if they had diabetes mellitus', '394 patients <70 years of age (or <60 years of age if they had diabetes mellitus']",['RA or free RITA graft'],"['10-year patient survival estimate', '10-year graft failure', '10-year patency', '10-year patency rate of the RA', 'patient survival estimate']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}]",394.0,0.29833,The 10-year patency rate of the RA is significantly higher than that of the free RITA and better than that of the SV.,"[{'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Buxton', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia (B.F.B., J.R., S.C.M., S.S., G.M.).'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Hayward', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences (B.F.B., P.A.H., J.R., A.R., S.S., G.M., D.L.H.), University of Melbourne, Australia.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Raman', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia (B.F.B., J.R., S.C.M., S.S., G.M.).'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Moten', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia (B.F.B., J.R., S.C.M., S.S., G.M.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosalion', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences (B.F.B., P.A.H., J.R., A.R., S.S., G.M., D.L.H.), University of Melbourne, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Statistical Consulting Centre (I.G.), University of Melbourne, Australia.'}, {'ForeName': 'Siven', 'Initials': 'S', 'LastName': 'Seevanayagam', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia (B.F.B., J.R., S.C.M., S.S., G.M.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matalanis', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia (B.F.B., J.R., S.C.M., S.S., G.M.).'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Bristol Heart Institute, University of Bristol, United Kingdom (U.B.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY (M.G.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hare', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences (B.F.B., P.A.H., J.R., A.R., S.S., G.M., D.L.H.), University of Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.045427']
2552,33017428,Mortality rate-dependent variations in antenatal corticosteroid-associated outcomes in very low birth weight infants with 23-34 weeks of gestation: A nationwide cohort study.,"Antenatal corticosteroid (ACS) administration has been known as one of the most effective treatment in perinatal medicine, but the beneficial effects of ACS may vary not only gestational age, but also the quality of perinatal and neonatal care of the institution. This nationwide cohort study of the Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017. The 9,142 eligible infants were assigned into two groups-group 1 and 2 <50% and ≥50% mortality rate, respectively, for 23-24 weeks' gestation-reflecting the quality of perinatal and neonatal care. Each group of infants were further stratified into 23-24, 25-26, 27-28, and 29-34 weeks of gestation age. Despite comparable ACS usage between group 1 (82%) and group 2 (81%), the benefits of ACS were only observed in group 1. In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2. In this study the overall data was congruent with the previous findings stating that ACS use decreases mortality and morbidity. These results indicate that the improved mortality of infants at 23-24 weeks' gestation reflects the quality improvement of perinatal and neonatal intensive care, which is a prerequisite to the benefits of ACS.",2020,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","['9,142 eligible infants', 'Korean Neonatal Network (KNN) data was consisted of <1,500g infants born at 23-34 weeks at 67 KNN hospitals between 2013 and 2017', 'very low birth weight infants with 23-34 weeks of gestation']",['Antenatal corticosteroid (ACS'],"['Mortality rate', 'benefits of ACS', 'early-onset sepsis and respiratory distress syndrome', 'mortality and IVH', 'mortality and morbidity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",9142.0,0.0542073,"In the multivariable analyses, infants of group 1 showed significant decrease in mortality and IVH at gestational age 23-24 weeks with ACS use, and the decrease was also seen in early-onset sepsis and respiratory distress syndrome at gestational age of 29-34 weeks while there were no significant decrease in group 2.","[{'ForeName': 'Jin Kyu', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Jeonbuk National University School of Medicine, Jeonju, Korea.'}, {'ForeName': 'Jong Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Pediatrics, Ilsan Paik Hospital, InJe University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Statistic and Data Center, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Yun Sil', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Soon', 'Initials': 'WS', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0240168']
2553,33017434,Whole-body protein kinetics in critically ill patients during 50 or 100% energy provision by enteral nutrition: A randomized cross-over study.,"BACKGROUND


Enteral nutrition (EN) is a ubiquitous intervention in ICU patients but there is uncertainty regarding the optimal dose, timing and importance for patient-centered outcomes during critical illness. Our research group has previously found an improved protein balance during normocaloric versus hypocaloric parenteral nutrition in neurosurgical ICU patients. We now wanted to investigate if this could be demonstrated in a general ICU population with established enteral feeding, including patients on renal replacement therapy.
METHODS


Patients with EN >80% of energy target as determined by indirect calorimetry were randomized to or 50% or 100% of current EN rate. After 24 hours, whole-body protein kinetics were determined by enteral and parenteral stable isotope tracer infusions. Treatment allocation was then switched, and tracer investigations repeated 24 hours later in a crossover design with patients serving as their own controls.
RESULTS


Six patients completed the full protocol. During feeding with 100% EN all patients received >1.2 g/kg/day of protein. Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044). The oxidation rate of phenylalanine was unaltered (p = 0.78).
CONCLUSIONS


It is possible to assess whole-body protein turnover using a stable isotope technique in critically ill patients during enteral feeding and renal replacement therapy. Our results also suggest a better whole-body protein balance during full dose as compared to half dose EN. As the sample size was smaller than anticipated, this finding should be confirmed in larger studies.",2020,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"['neurosurgical ICU patients', 'ICU patients', 'Patients with EN >80% of energy target as determined by indirect calorimetry', 'general ICU population with established enteral feeding, including patients on renal replacement therapy', 'critically ill patients during enteral feeding and renal replacement therapy', 'critically ill patients during 50 or 100% energy provision by enteral nutrition']",['Enteral nutrition (EN'],"['Mean whole-body protein balance', 'protein balance', 'oxidation rate of phenylalanine']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]",,0.0217836,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundström Rehal', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Liebau', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wernerman', 'Affiliation': 'Division of Anesthesia and Intensive Care, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Rooyackers', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240045']
2554,32997710,Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.,"OBJECTIVE


Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe.
MATERIALS AND METHODS


We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses.
RESULTS


2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis.
CONCLUSIONS


2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.",2020,"RESULTS


2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10.","['voluntary medical male circumcision (VMMC', ""Zimbabwe's voluntary medical male circumcision program""]",[],"['cost-effectiveness', 'costs due to text messaging', 'clinic visit costs', 'AE ascertainment', 'Costs']","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.0549168,"RESULTS


2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10.","[{'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Mendelsohn', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mauhy', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Marrianne M', 'Initials': 'MM', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}]",PloS one,['10.1371/journal.pone.0239915']
2555,33004234,The Development and Preliminary Impact of CAMP Air: A Web-based Asthma Intervention to Improve Asthma Among Adolescents.,"OBJECTIVE


Describe the development and preliminary impact of CAMP Air, a web-based intervention for adolescents with uncontrolled asthma.
MATERIALS AND METHODS


CAMP Air was developed using an iterative process with input from stakeholders and incorporating usability testing results (n = 14 adolescents). To test CAMP Air's initial impact, 61 adolescents from two New York City public high schools (n = 37) and from clinics, community-based organizations, and third-party recruitment services (i.e., community sample; n = 24) were enrolled in a randomized pilot trial. Participants were randomized to CAMP Air (n = 30) or information-and-referral control intervention (n = 31). A point-person worked with school participants to complete CAMP Air.
RESULTS


CAMP Air participants were satisfied with the intervention and its value for supporting self-management, completing on average 6 of 7 modules. Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits. Adolescents enrolled in schools completed more modules and had significantly fewer nights woken and school absences than community enrollees.
CONCLUSION


CAMP Air improves asthma outcomes among adolescents with uncontrolled asthma.
PRACTICE IMPLICATIONS


A web-based intervention CAMP Air is a promising intervention. When a point-person works with adolescents, CAMP Air's access and impact are improved.",2020,"Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits.","['CAMP Air was developed using an iterative process with input from stakeholders and incorporating usability testing results (n = 14 adolescents', 'Adolescents', 'A point-person worked with school participants to complete CAMP Air', '61 adolescents from two New York City public high schools (n = 37) and from clinics, community-based organizations, and third-party recruitment services (i.e., community sample; n = 24', 'adolescents with uncontrolled asthma']","['CAMP Air', 'CAMP Air (n = 30) or information-and-referral control intervention']","['asthma outcomes', 'nights woken and school absences', 'asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits']","[{'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0393761', 'cui_str': 'Middle insomnia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}]",24.0,0.0356156,"Relative to controls, CAMP Air participants demonstrated significantly improved asthma knowledge, asthma control, night wakening and school absences, and less risk for urgent care visits.","[{'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, United States. Electronic address: jb3958@cumc.columbia.edu.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'Columbia University School of Nursing, United States.'}, {'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Columbia University School of Nursing, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Columbia University Mailman School of Public Health, United States.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Florida State University, Center for Translational Behavioral Science, United States.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'DeRosier', 'Affiliation': '3C Institute, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Thomas', 'Affiliation': '3C Institute, United States.'}]",Patient education and counseling,['10.1016/j.pec.2020.09.011']
2556,33006618,Effect of Avoiding Cow's Milk Formula at Birth on Prevention of Asthma or Recurrent Wheeze Among Young Children: Extended Follow-up From the ABC Randomized Clinical Trial.,"Importance


Children with food allergies may develop asthma or recurrent wheeze.
Objective


To evaluate whether asthma or recurrent wheeze among children were changed by avoiding supplementing breastfeeding (BF) with cow's milk formula (CMF) in the first 3 days of life.
Design, Setting, and Participants


This randomized, unmasked, clinical trial was conducted at 1 university hospital in Japan beginning October 2013 with follow-up examinations occurring until January 2020. A total of 312 newborns at risk for atopy were randomized and assigned to either BF with or without amino acid-based elemental formula (EF) or BF with CMF, with follow-up examinations for participants showing signs of atopy conducted at 24 months. Follow-up examinations ran through January 2020.
Interventions


Immediately after birth, newborns were randomly assigned (1:1 ratio) to either breastfeeding with or without amino acid-based elemental formula for at least the first 3 days of life (no CMF group) or breastfeeding supplemented with CMF (≥5 mL/d) from the first day of life to 5 months of age (CMF group).
Main Outcomes and Measures


Asthma or recurrent wheeze diagnosed by the pediatric allergy specialists of this trial; subgroups were stratified by serum levels of 25-hydroxyvitamin D and IgE.
Results


Of 312 infants (156 [50.0%] randomized to the no CMF group), 302 (96.8%) were followed up at their second birthday: 77 of 151 (51.0%) in the no CMF group and 81 of 151 (53.6%) in the CMF group underwent extended follow-up because of having atopic conditions. Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002). In participants with vitamin D levels above the median at 5 months of age, asthma or recurrent wheeze developled in 5 (6.4%) children in the no CMF group, significantly less than in the children in the CMF group (17 [24.6%]; risk difference, -0.182; 95% CI, -0.298 to -0.067; P for interaction = .04). In the highest quartile group of total IgE at age 24 months, asthma or recurrent wheeze developed in 2 children (5.3%) in the no CMF group, significantly less than the children in the CMF group (14 [43.8%]; risk difference, -0.385; 95% CI, -0.571 to -0.199; P for interaction = .004).
Conclusions and Relevance


The findings of this study suggest that avoiding CMF supplementation in the first 3 days of life has the potential to reduce the risk of asthma or recurrent wheeze in young children, especially among those with high vitamin D or high IgE levels.
Trial Registration


umin.ac.jp/ctr Identifier: UMIN000011577.",2020,"Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002).","['Young Children', '1 university hospital in Japan beginning October 2013 with follow-up examinations occurring until January 2020', '312 newborns at risk for atopy']","[""avoiding supplementing breastfeeding (BF) with cow's milk formula (CMF"", ""Avoiding Cow's Milk Formula"", 'BF with or without amino acid-based elemental formula (EF) or BF with CMF, with follow-up examinations', 'breastfeeding with or without amino acid-based elemental formula for at least the first 3 days of life (no CMF group) or breastfeeding supplemented with CMF', 'avoiding CMF supplementation', 'CMF']","['Asthma or recurrent wheeze', 'asthma or recurrent wheeze', 'Main Outcomes and Measures\n\n\nAsthma or recurrent wheeze diagnosed by the pediatric allergy specialists', 'Prevention of Asthma or Recurrent Wheeze']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0392707', 'cui_str': 'Atopy'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3853260', 'cui_str': 'Elemental formula'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",,0.114499,"Asthma or recurrent wheeze developed in 15 (9.9%) of the children in the no CMF group, significantly less than the children in the CMF group (27 [17.9%]; risk difference, -0.079; 95% CI, -0.157 to -0.002).","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tachimoto', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Imanari', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Mezawa', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Okuyama', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daishi', 'Initials': 'D', 'LastName': 'Hirano', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Gocho', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.18534']
2557,33006749,Can Physical Activity While Sedentary Produce Health Benefits? A Single-Arm Randomized Trial.,"BACKGROUND


Sedentary time poses a risk to health. Substituting physical activity for inactivity is obvious but this requires a behavior change. Interventions advocated to decrease uninterrupted physical inactivity (defined as Metabolic Equivalent of Task (METS) less than 1.5) are important. One such intervention is accomplished with the Gentle Jogger (GJ), a low risk motorized wellness device which produces effortless, rapid motion of the lower extremities simulating locomotion or fidgeting. GJ produces health benefits in type 2 diabetes, heart disease, and high blood pressure. The purpose of this trial was to ascertain whether GJ increases METS above 1.5 to explain its effectiveness despite sedentary behavior or whether tapping is responsible.
METHODS


A randomized single-arm trial was conducted. Subjects were randomized to begin the study in either the supine or seated postures and on the same day crossed over with the starting posture reversed. Oxygen consumption was measured at rest and during GJ.
RESULTS


Twenty-six subjects were studied (15 women and 11 men) with a mean age of 44 ± 15 years and BMI 27.9 ± 5.0, 19 were overweight or obese, and 7 had normal BMI. GJ increased oxygen consumption and METS 15% in the seated posture and 13% in the supine posture. No individual receiving GJ achieved METS exceeding 1.5.
CONCLUSIONS


In a moderately obese population, GJ in seated or supine posture did not exceed 1.5 METS. The values are comparable to those reported for sit-stand interventions and cannot explain the health benefits of GJ.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03602365 . Registered on July 26, 2018.",2020,"No individual receiving GJ achieved METS exceeding 1.5.
","['Twenty-six subjects were studied (15 women and 11 men) with a mean age of 44 ± 15 years and BMI 27.9 ± 5.0, 19 were overweight or obese, and 7 had normal BMI']",['GJ'],"['oxygen consumption', 'uninterrupted physical inactivity', 'Oxygen consumption']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",[],"[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",26.0,0.105384,"No individual receiving GJ achieved METS exceeding 1.5.
","[{'ForeName': 'Marvin A', 'Initials': 'MA', 'LastName': 'Sackner', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Lopez', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Banderas', 'Affiliation': 'Sackner Wellness Products LLC, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Adams', 'Affiliation': 'Mt. Sinai Medical Center of Greater Miami, Miami Beach, FL, USA. Tony@msmc.com.'}]",Sports medicine - open,['10.1186/s40798-020-00278-3']
2558,33008422,OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial.,"BACKGROUND


Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN.
METHODS


BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250-15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates.
DISCUSSION


Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy.
TRIAL REGISTRATION


ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957.",2020,The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival.,"['patients with four or more involved lymph nodes', 'patients with early-stage BC and limited involvement of the SLN', 'BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250-15,000 copies/µL will be eligible']",['Conservative surgery followed by breast and nodal irradiation'],"['comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates', '5-year disease free survival', 'non-inferiority of the incidental irradiation of axillary nodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0534010', 'cui_str': 'One-Step dentin bonding system'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0444507', 'cui_str': 'Incidental'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}]",15000.0,0.0916466,The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Algara López', 'Affiliation': 'Radiation Oncology Department, Del Mar Hospital, Autonomous University of Barcelona, Hospital del Mar Medical Research Institute, Passeig Maritim, 25, 08003, Barcelona, Spain. malgara@parcdesalutmar.cat.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Rodríguez García', 'Affiliation': 'Radiation Oncology Department, Virgen del Rocío University Hospital, Seville, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Beato Tortajada', 'Affiliation': 'Radiation Oncology Department, Castellón Provincial Hospital, Castellón de La Plana, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Martínez Arcelus', 'Affiliation': 'Radiation Oncology Department, La Fe Polytechnic University Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Salinas Ramos', 'Affiliation': 'Radiation Oncology Department, Santa Lucia General University Hospital, Cartagena, Spain.'}, {'ForeName': 'José Reyes', 'Initials': 'JR', 'LastName': 'Rodríguez Garrido', 'Affiliation': 'Radiation Oncology Department, University Hospital of Leon, León, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sanz Latiesas', 'Affiliation': 'Radiation Oncology Department, Del Mar Hospital, Pompeu Fabra University, Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soler Rodríguez', 'Affiliation': 'Radiation Oncology Department, De La Ribera Hospital, Alzira, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Juan Rijo', 'Affiliation': 'Radiation Oncology Department, Cabueñes University Hospital, Gijón, Spain.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Flaquer García', 'Affiliation': 'Araba Txagorritxu University Hospital, Vitoria, Spain.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01672-7']
2559,33008427,"The MUK eight protocol: a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor.","BACKGROUND


Multiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib. The combination of cyclophosphamide and dexamethasone (CD) is a recognised treatment option for patients with relapsed refractory multiple myeloma (RRMM) who have relapsed after treatment with bortezomib and lenalidomide, whilst also often being combined with newer proteasome inhibitors. The most apparent combination for ixazomib is therefore with CD.
METHODS


MUK eight is a randomised, controlled, open, parallel group, multi-centre phase II trial that will recruit patients with RRMM who have relapsed after treatment with thalidomide, lenalidomide, and a proteasome inhibitor. The primary objective of the trial is to evaluate whether ixazomib in combination with cyclophosphamide and dexamethasone (ICD) has improved clinical activity compared to CD in terms of progression-free survival (PFS). Secondary objectives include comparing toxicity profiles and the activity and cost-effectiveness of both treatments. Since opening, the trial has been amended to allow all participants who experience disease progression (as per the IMWG criteria) on the CD arm to subsequently switch to receive ICD treatment, once progression has been confirmed with two clinical members of the Trial Management Group (TMG). This 'switch' phase of the study is exploratory and will assess second progression-free survival measured from randomisation to second disease progression (PFS2) and progression-free survival from the point of switching to second disease progression (PFS Switch) in participants who switch from CD to ICD treatment.
DISCUSSION


Development of ixazomib offers the opportunity to further investigate the value of proteasome inhibition through oral administration in the treatment of RRMM. Previous studies investigating the safety and efficacy of ICD in patients with RRMM demonstrate a toxicity profile consistent with ixazomib in combination with lenalidomide and dexamethasone, whilst the combination showed possible activity in RRMM patients. Further investigation of the anti-tumour effect of this drug in RRMM patients is therefore warranted, especially since no trials comparing CD with ICD have been completed at present.
TRIAL REGISTRATION


ISRCTN number: ISRCTN58227268 . Registered on 26 August 2015.",2020,Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib.,"['number', 'participants who switch from CD to ICD treatment', 'patients with RRMM', 'patients with relapsed refractory multiple myeloma (RRMM) who have relapsed after treatment with', 'relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor', 'patients with RRMM who have relapsed after treatment with', 'RRMM patients', 'participants who experience disease progression (as per the IMWG criteria) on the CD arm to subsequently switch to receive']","['lenalidomide and dexamethasone', 'bortezomib and lenalidomide', 'cyclophosphamide and dexamethasone', 'cyclophosphamide and dexamethasone (CD', 'bortezomib', 'ICD', 'ixazomib', 'cyclophosphamide and dexamethasone (ICD', 'Ixazomib', 'thalidomide, lenalidomide, and a proteasome inhibitor']",['toxicity profiles and the activity and cost-effectiveness'],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0622291,Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib.,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hinsley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. K.M.Walker@leeds.ac.uk.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Sherratt', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bailey', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Flanagan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'McKee', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Brudenell Straw', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Holger W', 'Initials': 'HW', 'LastName': 'Auner', 'Affiliation': 'Centre for Haematology, Imperial College London, London, UK.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': 'Centre for Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04739-8']
2560,33008432,Home-based motor imagery intervention improves functional performance following total knee arthroplasty in the short term: a randomized controlled trial.,"BACKGROUND


Motor imagery (MI) is effective in improving motor performance in the healthy asymptomatic adult population. However, its possible effects among older orthopaedic patients are still poorly investigated. Therefore, this study explored whether the addition of motor imagery to routine physical therapy reduces the deterioration of quadriceps muscle strength and voluntary activation (VA) as well as other variables related to motor performance in patients after total knee arthroplasty (TKA).
METHODS


Twenty-six patients scheduled for TKA were randomized to either MI practice combined with routine physical therapy group (MIp) or to a control group receiving physical therapy alone (CON). MIp consisted of maximal voluntary isometric contraction (MViC) task: 15 min/day in the hospital, then 5 times/week in their homes for 4 weeks. MViC and VA of quadriceps muscle, knee flexion and extension range of motion, pain level, along with a Timed Up-and-Go Test (TUG) and self-reported measure of physical function (assessed using the Oxford Knee Score questionnaire [OKS]) were evaluated before (PRE) and 1 month after surgery (POST).
RESULTS


Significantly better rehabilitation outcomes were evident on the operated leg for the MIp group compared to CON: at POST, the MIp showed lower strength decrease (p = 0.012, η 2  = 0.237) and unaltered VA, significantly greater than CON (p = 0.014, η 2  = 0.227). There were no significant differences in knee flexion and extension range of motion and pain level (p > 0.05). Further, MIp patients performed better in TUG (p < 0.001, η 2  = 0.471) and reported better OKS scores (p = 0.005, η 2  = 0.280). The non-operated leg showed no significant differences in any outcomes at POST (all p > 0.05). In addition, multiple linear regression analysis showed that failure of voluntary activation explained 47% of the quadriceps muscle strength loss, with no significant difference in perceived level of pain.
CONCLUSION


MI practice, when added to physical therapy, improves both objective and subjective measures of patients' physical function after TKA, and facilitates transfer of MI strength task on functional mobility.
TRIAL REGISTRATION


Retrospectively registered on ClinicalTrials.gov NCT03684148.",2020,There were no significant differences in knee flexion and extension range of motion and pain level (p > 0.05).,"['healthy asymptomatic adult population', 'Twenty-six patients scheduled for TKA', 'patients after total knee arthroplasty (TKA', 'total knee arthroplasty in the short term', 'older orthopaedic patients']","['routine physical therapy', 'Home-based motor imagery intervention', 'MI practice combined with routine physical therapy group (MIp) or to a control group receiving physical therapy alone (CON', 'maximal voluntary isometric contraction (MViC) task', 'CON', 'Motor imagery (MI']","['failure of voluntary activation', 'knee flexion and extension range of motion and pain level', 'MViC and VA of quadriceps muscle, knee flexion and extension range of motion, pain level, along with a Timed Up-and-Go Test (TUG) and self-reported measure of physical function (assessed using the Oxford Knee Score questionnaire [OKS', 'level of pain', 'deterioration of quadriceps muscle strength and voluntary activation (VA', 'OKS scores', 'rehabilitation outcomes', 'functional performance', 'strength decrease']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",26.0,0.0703747,There were no significant differences in knee flexion and extension range of motion and pain level (p > 0.05).,"[{'ForeName': 'Armin H', 'Initials': 'AH', 'LastName': 'Paravlic', 'Affiliation': 'Science and Research Centre Koper, Institute for Kinesiology Research, Koper, Slovenia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno, Italy. n.maffulli@qmul.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kovač', 'Affiliation': 'Orthopaedic Hospital Valdoltra, Ankaran, Slovenia.'}, {'ForeName': 'Rado', 'Initials': 'R', 'LastName': 'Pisot', 'Affiliation': 'Science and Research Centre Koper, Institute for Kinesiology Research, Koper, Slovenia.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01964-4']
2561,33008451,Effect of dexmedetomidine on intraoperative Surgical Pleth Index in patients undergoing video-assisted thoracoscopic lung lobectomy.,"BACKGROUND


The Surgical Pleth Index (SPI) is a monitoring method that reflects painful stimuli during general anesthesia, and dexmedetomidine is an analgesic adjuvant with an opioid-sparing effect. But up to now, it is still unclear whether dexmedetomidine has any influence on SPI. To investigate whether dexmedetomidine has an effect on SPI during video-assisted thoracoscopic surgery.
METHODS


We enrolled 94 patients who underwent video-assisted thoracoscopic lung lobectomy. Patients were randomly assigned to a dexmedetomidine group (dexmedetomidine: 0.8 μg/kg administered for 10 min before anesthesia) or normal saline group (equal volume of normal saline). SPI and vital signs were recorded. The number rating scale (NRS) pain score was also evaluated.
RESULTS


SPI values were significantly lower in the dexmedetomidine group than in the normal saline group at intubation and at discharge from the postanesthesia care unit. Compared with the normal saline group, mean arterial pressure and heart rate were both significantly lower in the dexmedetomidine group at intubation. Heart rate was lower at skin incision in the dexmedetomidine group. The NRS score in the normal saline group was noticeably higher vs. the dexmedetomidine group at discharge from the postanesthesia care unit.
CONCLUSIONS


Dexmedetomidine decreased intraoperative SPI and NRS scores. Our results showed that dexmedetomidine attenuated noxious stimuli.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR): ChiCTR-OOC-16009450 , Registered 16 October, 2016.",2020,"RESULTS


SPI values were significantly lower in the dexmedetomidine group than in the normal saline group at intubation and at discharge from the postanesthesia care unit.","['94 patients who underwent', 'patients undergoing video-assisted thoracoscopic lung lobectomy']","['Dexmedetomidine', 'video-assisted thoracoscopic lung lobectomy', 'dexmedetomidine', 'normal saline', 'dexmedetomidine group (dexmedetomidine: 0.8\u2009μg/kg administered for 10\u2009min before anesthesia) or normal saline group (equal volume of normal saline']","['noxious stimuli', 'intraoperative Surgical Pleth Index', 'intraoperative SPI and NRS scores', 'Heart rate', 'SPI values', 'SPI and vital signs', 'NRS score', 'mean arterial pressure and heart rate', 'number rating scale (NRS) pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4049463', 'cui_str': 'Video-assisted thoracoscopic lung lobectomy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4049463', 'cui_str': 'Video-assisted thoracoscopic lung lobectomy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",94.0,0.321608,"RESULTS


SPI values were significantly lower in the dexmedetomidine group than in the normal saline group at intubation and at discharge from the postanesthesia care unit.","[{'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia Surgery, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu, China.'}, {'ForeName': 'Xiao-Qi', 'Initials': 'XQ', 'LastName': 'Kong', 'Affiliation': 'Department of Anesthesia Surgery, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu, China.'}, {'ForeName': 'Fu-Hai', 'Initials': 'FH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesia Surgery, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu, China. jifuhai@hotmail.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01346-1']
2562,18895853,Implantation of complementary hormones; trial for the treatment of hemogeno-haemophilic syndrome by estradiol implantation.,,1947,,[],['estradiol implantation'],[],[],"[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.0258654,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'MICHON', 'Affiliation': ''}]",Bulletins et memoires de la Societe medicale des hopitaux de Paris,[]
2563,18896778,On the diopter of the trial glasses.,,1947,,[],[],[],[],[],[],,0.0500633,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'GRAFF', 'Affiliation': ''}]",Klinische Monatsblatter fur Augenheilkunde und fur augenarztliche Fortbildung,[]
2564,18898724,Vitamin D2 treatment trial for bronchial tuberculosis.,,1947,,['bronchial tuberculosis'],['Vitamin D2'],[],"[{'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}]",[],,0.0338893,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'DUFOURT', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'MOUNIER-KUHN', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'DESPIERRES', 'Affiliation': ''}]",Revue de la tuberculose,[]
2565,18884536,Trial of treatment of mycoses with sulfamido-thiourea.,,1948,,['mycoses with sulfamido-thiourea'],[],[],"[{'cui': 'C0018365', 'cui_str': 'Gutimine'}]",[],[],,0.0180459,,"[{'ForeName': '', 'Initials': '', 'LastName': 'MORIAME', 'Affiliation': ''}]",Archives belges de dermatologie et de syphiligraphie,[]
2566,18891970,Trial of treatment of pyorrhea by vasodilators.,,1948,,[],['pyorrhea by vasodilators'],[],[],"[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}]",[],,0.0249753,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'PLAS', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'FRICOU', 'Affiliation': ''}]",Revue de stomatologie,[]
2567,18892018,Trial of treatment of acute male gonorrhea by single injection of penicillin G.,,1948,,['acute male gonorrhea'],['penicillin G'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}]","[{'cui': 'C0030827', 'cui_str': 'Penicillin G'}]",[],,0.0399048,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'DEMONCHY', 'Affiliation': ''}]",Bulletin de la Societe francaise de dermatologie et de syphiligraphie,[]
2568,18152395,Trial of treatment of lipoid nephrosis by plasma therapy following the diet of raw vegetables.,,1949,,[],['lipoid nephrosis by plasma therapy'],[],[],"[{'cui': 'C0027721', 'cui_str': 'Minimal change disease'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0203291,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'CAMELIN', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'GUIBERT', 'Affiliation': ''}]",Lyon medical,[]
2569,18229041,Trial to treat male gonorrhea with oral penicillin.,,1949,,['male gonorrhea with oral penicillin'],[],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}]",[],[],,0.0556772,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'PELLERAT', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MADONNA', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'TERRIER', 'Affiliation': ''}]",Lyon medical,[]
2570,18860707,Trial of treatment of the lipoid disk with subtosan; First results.,,1947,,[],['lipoid disk with subtosan'],[],[],"[{'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]",[],,0.0173802,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'RAVAULT', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'PELLERAT', 'Affiliation': ''}]",Lyon medical,[]
2571,18136256,Trial of prevention and treatment of postoperative adhesions.,,1949,,[],[],[],[],[],[],,0.0332469,,"[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'REYMOND', 'Affiliation': ''}]",Journal des praticiens; revue generale de clinique et de therapeutique,[]
2572,18139636,Trial of the treatment of Parkinson's disease with the antigan and neo-antergan.,,1949,,"[""Parkinson's disease with the antigan and neo-antergan""]",[],[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003150', 'cui_str': 'Antergan'}]",[],[],,0.019437,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'GEREST', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'MARION', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'NICOLLET', 'Affiliation': ''}]",Lyon medical,[]
2573,33014466,Multicomponent Exercise Training Improves Gait Ability of Older Women Rather than Strength Training: A Randomized Controlled Trial.,"Objective


The aim of this study was to compare the effects of multicomponent and strength training programs on dynamic balance, functional capacity, and gait ability in older women.
Methods


Thirty individuals (67 ± 4.3 years; 30.6 ± 3.9 kg/m 2 ) were trained for 12 weeks (3 times per week), following multicomponent (MG: exercises focusing on agility, balance, muscle strength, and aerobic) and strength programs (SG: lower limbs strength exercise).
Results


Peak torque of hip flexors ( p =0.020) and extensors ( p =0.009) and knee flexors ( p =0.001) of SG was greater than that of MG at posttraining. In addition, both groups increased peak torque of knee extensors ( p =0.002) and plantar extensors with higher effect size for SG ( d  = -0.41 and -0.48), whereas MG presented higher effect size for plantar flexors muscles ( d  = -0.55). Only the SG improved the rate of torque development of knee extensors (29%;  p =0.002), and this variable was also greater to SG than MG at posttraining (106%). The SG and MG improved dynamic balance although SG presented higher effect size ( d  = 0.61). Both groups improved the performance on 30 s sit to stand test ( p =0.010) with higher effect size for MG ( d  = -0.54). Only the MG improved the stride length (4%;  p =0.011) and gait speed (10%;  p =0.024). In addition, the groups improved toe clearance ( p =0.035) and heel contact ( p =0.010) with higher effect sizes for MG ( d  = -0.066 and 1.07).
Conclusion


Strength training should be considered to increase muscle function and dynamic balance in older women, whereas multicomponent training should be considered to increase functional capacity and gait ability in this population.",2020,"Results


Peak torque of hip flexors ( p =0.020) and extensors ( p =0.009) and knee flexors ( p =0.001) of SG was greater than that of MG at posttraining.","['older women', 'Methods\n\n\nThirty individuals (67\u2009±\u20094.3 years; 30.6\u2009±\u20093.9\u2009kg/m 2 ', 'Older Women Rather than Strength Training']","['multicomponent and strength training programs', 'Multicomponent Exercise Training', 'multicomponent (MG: exercises focusing on agility, balance, muscle strength, and aerobic) and strength programs (SG: lower limbs strength exercise']","['knee flexors', 'Gait Ability', 'dynamic balance, functional capacity, and gait ability', 'peak torque of knee extensors', 'plantar flexors muscles', 'rate of torque development of knee extensors', 'SG', 'performance on 30 s sit to stand test', 'heel contact', 'toe clearance', 'gait speed', 'muscle function and dynamic balance', 'stride length', 'Peak torque of hip flexors', 'dynamic balance', 'plantar extensors with higher effect size for SG']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.027448,"Results


Peak torque of hip flexors ( p =0.020) and extensors ( p =0.009) and knee flexors ( p =0.001) of SG was greater than that of MG at posttraining.","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolf', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Rafaella R', 'Initials': 'RR', 'LastName': 'Locks', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Paula B', 'Initials': 'PB', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Paulo C B', 'Initials': 'PCB', 'LastName': 'Bento', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}, {'ForeName': 'André L F', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Attilio N', 'Initials': 'AN', 'LastName': 'Carraro', 'Affiliation': 'Faculty of Education, Free University of Bozen-Bolzano, Brixen-Bressanone, Italy.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, Paraná, Brazil.'}]",Journal of aging research,['10.1155/2020/6345753']
2574,33014663,A Single Centre Randomised Control Study to Assess the Impact of Pre-Operative Carbohydrate Loading on Women Undergoing Major Surgery for Epithelial Ovarian Cancer.,"Objective Historically, patients have fasted before elective surgery to ensure an empty stomach to avoid aspiration. A fasting-induced catabolic state however may adversely influence recovery after surgery. Our study was designed to test the effect of oral carbohydrate loading on clinical parameters in patients undergoing major surgery for advanced-stage ovarian cancer. Methods A double-blinded single-centre randomised trial was designed to recruit 110 patients with advanced-stage epithelial ovarian cancer undergoing either primary surgery, or neoadjuvant chemotherapy prior to debulking surgery. Following written informed consent, the patients were randomised into two groups. Group 1 received the carbohydrate drink (intervention) and group 2 received flavoured water (placebo). The quantity of fluid in both groups was 800ml the night before the surgery and 400ml two hours before the induction of anaesthesia. The primary endpoint of the study was the Length of Hospital Stay (LoHS); the secondary parameters assessed were pain scores, nausea and vomiting scores, bowel function, and postoperative complication rate. Results Between March 2009 and December 2011, 80 patients were randomised and 75 completed the study. A decision was made to close the trial early as a change in routine clinical practice meant that patients were admitted on the day of surgery rather than a day before. Analysis of the data revealed that there were no significant differences between the study groups in terms of LoHS and other clinical parameters. Conclusion In this single-center study, which failed to recruit the planned number of patients, we were unable to demonstrate that oral carbohydrate intake pre-operatively has significant impact on the recovery process or the length of hospitalisation postoperatively. Future studies should examine all aspects of an Enhanced Recovery Program after Surgery as a package as compared to a single element to enhance patient outcome.",2020,Analysis of the data revealed that there were no significant differences between the study groups in terms of LoHS and other clinical parameters.,"['Results Between March 2009 and December 2011, 80 patients were randomised and 75 completed the study', 'patients undergoing major surgery for advanced-stage ovarian cancer', 'Women Undergoing Major Surgery for Epithelial Ovarian Cancer', '110 patients with advanced-stage epithelial ovarian cancer undergoing either primary surgery, or neoadjuvant chemotherapy prior to debulking surgery']","['carbohydrate drink (intervention) and group 2 received flavoured water (placebo', 'Pre-Operative Carbohydrate Loading', 'oral carbohydrate loading']","['pain scores, nausea and vomiting scores, bowel function, and postoperative complication rate', 'quantity of fluid', 'Length of Hospital', 'Stay (LoHS']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",80.0,0.257758,Analysis of the data revealed that there were no significant differences between the study groups in terms of LoHS and other clinical parameters.,"[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Al-Hirmizy', 'Affiliation': 'Obstetrics and Gynaecology, Diana Princess of Wales Hospital, Grimsby, GBR.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wood', 'Affiliation': 'Gynaecologic Oncology, Lancashire Teaching Hospital NHS Foundation Trust, Preston, GBR.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'School of Medicine and Dentistry, University of Central Lancashire, Preston, GBR.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': 'Clinical Oncology/Research and Development Department, Leeds Teaching Hospitals NHS Trust, Leeds, GBR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nugent', 'Affiliation': 'Gynaecologic Oncology, Leeds Teaching Hospitals NHS Trust, Leeds, GBR.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Health Sciences, University of Leeds Institute of Health Sciences, Leeds, GBR.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Gynaecology, Leeds Teaching Hospitals NHS Trust, Leeds, GBR.'}]",Cureus,['10.7759/cureus.10169']
2575,33014696,The added value of frequent physical activity group sessions in a combined lifestyle intervention: A cluster randomised trial in primary care.,"Combined lifestyle interventions (CLIs) that target both physical activity (PA) and diet have been shown to improve PA and health of adults who are overweight; however, optimal amount of guidance remains unclear. This study evaluated the effects of adding PA group sessions to a standard CLI in primary care in the Netherlands. 411 participants (BMI 34.5 ± 4.4 kg/m 2 ) in thirty locations were randomised into a one year CLI or CLI+. CLI comprised individual meetings with lifestyle coach (LSC) and physiotherapist, and group meetings with dietician. PA group sessions were added in CLI+. Primary outcome was minutes of moderate to vigorous PA per week. Secondary outcomes of PA, diet and cardiovascular risk factors (i.e. waist circumference, HbA1c and blood pressure) were evaluated after 12 and 24 months with multilevel analyses. Data were collected from 2010 to 2015. Significant between-group effects were only found for waist circumference, which was significantly lower at twelve months in the CLI+ group (p = 0.011), no other between-group differences were found. Several within-group changes were significant. After participating in the intervention, walking time increased with 83 ± 35 min/week and 100 ± 38 min/week, and BMI decreased with 0.7 ± 0.3 kg/m 2  and 1.5 ± 0.3 kg/m 2  in CLI and CLI+ respectively (p < 0.001). Diet, HbA1c and systolic blood pressure changed favourably in both groups. Adding PA group sessions did not elicit added, sustained benefits. A programme with individual meetings with LSC and physiotherapist, and group meetings with dietician can be sufficient to facilitate a healthy lifestyle and reduce cardiovascular risk factors in a population with overweight.",2020,"After participating in the intervention, walking time increased with 83 ± 35 min/week and 100 ± 38 min/week, and BMI decreased with 0.7 ± 0.3 kg/m 2  and 1.5 ± 0.3 kg/m 2  in CLI and CLI+ respectively (p < 0.001).","['411 participants (BMI 34.5\xa0±\xa04.4\xa0kg/m 2 ) in thirty locations', 'primary care in the Netherlands']","['CLI', 'CLI comprised individual meetings with lifestyle coach (LSC) and physiotherapist, and group meetings with dietician', 'Combined lifestyle interventions (CLIs) that target both physical activity (PA) and diet', 'PA', 'CLI or CLI']","['BMI', 'walking time', 'PA, diet and cardiovascular risk factors (i.e. waist circumference, HbA1c and blood pressure', 'waist circumference', 'Diet, HbA1c and systolic blood pressure', 'minutes of moderate to vigorous PA per week']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1453673', 'cui_str': 'CLU protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.018539,"After participating in the intervention, walking time increased with 83 ± 35 min/week and 100 ± 38 min/week, and BMI decreased with 0.7 ± 0.3 kg/m 2  and 1.5 ± 0.3 kg/m 2  in CLI and CLI+ respectively (p < 0.001).","[{'ForeName': 'Brenda A J', 'Initials': 'BAJ', 'LastName': 'Berendsen', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University Medical Centre, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Marike R C', 'Initials': 'MRC', 'LastName': 'Hendriks', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University Medical Centre, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Geert M', 'Initials': 'GM', 'LastName': 'Rutten', 'Affiliation': 'Maastricht University Campus Venlo, Venlo, the Netherlands.'}, {'ForeName': 'Stef P J', 'Initials': 'SPJ', 'LastName': 'Kremers', 'Affiliation': 'Health Promotion, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Hans H C M', 'Initials': 'HHCM', 'LastName': 'Savelberg', 'Affiliation': 'Nutrition and Movement Sciences, Maastricht University Medical Centre, PO Box 616, 6200 MD Maastricht, the Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101204']
2576,33014739,The Effect of Dignity Therapy on the Quality of Life of Patients with Cancer Receiving Palliative Care.,"Background


Patients with cancer deal with physical, psychosocial, spiritual, and existential problems that impact on their quality of life. This study aimed to assess the effect of dignity therapy on the quality of life of mentioned patients.
Materials and Methods


In this quasi-experimental study, 50 patients with cancer hospitalized in a palliative care center in Tehran, Iran, in 2017-18 who fulfilled inclusion criteria were selected through convenience sampling. The European Organization for Research and Treatment of Cancer Quality of Life-C15-Palliative (EORTC-QLQ-C15-PAl) questionnaire was filled by patients before and 2 weeks after dignity therapy. Data were analyzed using descriptive statistics such as frequency, mean, and standard deviation, as well as inferential statistics, including independent t-test and Chi-square test.
Results


Results showed that dignity-therapy led to more improvement in the quality of life of the intervention group (t 35,18 = 4.82,  p  = 0.001). There was also a significant difference between the two groups in terms of the physical functioning scale (t 32,96 = -2.60,p = 0.01) and emotional functioning (t  45,69 = 6.54,  p  < 0.001). We also found that dignity-therapy led to more improvement in nausea and vomiting (χ 2  = 5.71,  p  = 0.02), insomnia (χ 2  = 15.78,  p  < 0.001), appetite (χ 2  = 5.09,  p  = 0.02), and constipation (χ 2  = 12.50,  p  < 0.001).
Conclusions


The application of new approaches like-dignity therapy could benefit patients with cancer in terms of reducing their distress, improving symptom severity, physical and emotional functioning, and total quality of life.",2020,"There was also a significant difference between the two groups in terms of the physical functioning scale (t 32,96 = -2.60,p = 0.01) and emotional functioning (t  45,69 = 6.54,  p  < 0.001).","['50 patients with cancer hospitalized in a palliative care center in Tehran, Iran, in 2017-18 who fulfilled inclusion criteria were selected through convenience sampling', 'Patients with Cancer Receiving Palliative Care']","['dignity therapy', 'Dignity Therapy']","['Quality of Life', 'nausea and vomiting', 'physical functioning scale', 'symptom severity, physical and emotional functioning, and total quality of life', 'insomnia', 'quality of life', 'appetite', 'emotional functioning', 'Cancer Quality of Life-C15-Palliative (EORTC-QLQ-C15-PAl) questionnaire', 'constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C4704841', 'cui_str': 'Dignity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",50.0,0.049392,"There was also a significant difference between the two groups in terms of the physical functioning scale (t 32,96 = -2.60,p = 0.01) and emotional functioning (t  45,69 = 6.54,  p  < 0.001).","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Zaki-Nejad', 'Affiliation': 'MS of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nikbakht-Nasrabadi', 'Affiliation': 'Professor, Medical-Surgical Nursing Department, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arpi', 'Initials': 'A', 'LastName': 'Manookian', 'Affiliation': 'Assistant Professor, Medical-Surgical Nursing Department, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Shamshiri', 'Affiliation': 'Assistant Professor, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of nursing and midwifery research,['10.4103/ijnmr.IJNMR_51_19']
2577,33014931,An Integrated Approach for a New Pattern in Pediatric Primary Care: Interaction Mediation for Active and Efficient Medical Consultations.,"Introduction:  This study analyzed the impact of an innovative integrated approach in pediatric care on children's behavior and cooperation during care.  Methods:  The participants included 75 children aged 3-8 years (30 girls and 45 boys) recruited from a pediatric surgery department. The sample was categorized into three groups according to experimental condition: the Control, Playing, and Interaction groups.  Results:  A one-way ANOVA revealed significant differences in cooperation between the three groups [ F   (2,1)  = 5.52;  p  = 0.006]. A  post-hoc  analysis showed better performance in the Interaction group ( p  = 0.002) compared to the Control group during clinical care. The Control group also showed less cooperation compared to the Playing group ( p  = 0.009).  Conclusions:  The findings indicate that distraction before medical care can positively influence children's behavior, increasing their cooperation in medical settings. Future studies could objectively analyze physiological changes in children during medical care to better relieve anxiety and provide them with more efficient care.",2020,A  post-hoc  analysis showed better performance in the Interaction group ( p  = 0.002) compared to the Control group during clinical care.,"['participants included 75 children aged 3-8 years (30 girls and 45 boys) recruited from a pediatric surgery department', ""pediatric care on children's behavior and cooperation during care""]",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}]",[],[],75.0,0.0147762,A  post-hoc  analysis showed better performance in the Interaction group ( p  = 0.002) compared to the Control group during clinical care.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ranieri', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Guerra', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cilli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Di Giacomo', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.""}]",Frontiers in pediatrics,['10.3389/fped.2020.00530']
2578,33014971,"A Multi-Domain Intervention Protocol for the Potential Reversal of Cognitive Frailty: ""WE-RISE"" Randomized Controlled Trial.","Following the rapid increase of the aging population, health promotion and prevention of physical disability and dementia in older persons are essential for healthy aging. For example, there may be a potential to prevent or reverse cognitive frailty, the co-existence of both physical frailty and cognitive impairment in older persons. However, evidence-based interventions targeting the prevention or potential reversibility of cognitive frailty among community dwelling older adults are scarce. In this paper, we described the rationale, development and delivery of a multi-domain intervention comprising multi-component physical exercise prescription, cognitive training, dietary counseling and promotion of psychosocial support, called the WE-RISE trial. The aim of WE-RISE intervention is to potentially reverse cognitive frailty. This is a two-armed, single blinded, randomized controlled trial conducted over a duration of 6 months, at senior citizen activity centers within the Klang Valley, Malaysia. Ambulating, community dwelling older adults aged 60 years and above with cognitive frailty are randomized into two groups; (1) intervention group: which receives an instructor based ""WE-RISE"" intervention for the first 3 months, and then a home-based ""WE-RISE at Home"" intervention for the following 3 months; (2) control group: usual care with no modifications to their daily routine. Primary outcome is cognitive frailty status and secondary outcome include physical function, cognitive performance, nutritional status, psychosocial status and quality of life which are obtained during baseline screening and subsequent follow ups at 3rd and 6th month. Description of the intervention is done using the template for intervention description and replication (TIDieR) checklist. This trial protocol has received approval from Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM PPI/111/8/JEP-2018-558) and the Department of Social Welfare Malaysia (MyResearch Reference: JKMM 100/12/5/2: 2018/405). Trial registration number: ACTRN12619001055190.",2020,"Following the rapid increase of the aging population, health promotion and prevention of physical disability and dementia in older persons are essential for healthy aging.","['community dwelling older adults', 'Ambulating, community dwelling older adults aged 60 years and above with cognitive frailty', 'senior citizen activity centers within the Klang Valley, Malaysia', 'older persons', 'Universiti Kebangsaan Malaysia (UKM PPI/111/8/JEP-2018-558) and the Department of Social Welfare Malaysia']","['intervention group: which receives an instructor based ""WE-RISE"" intervention for the first 3 months, and then a home-based ""WE-RISE at Home"" intervention for the following 3 months; (2) control group: usual care with no modifications to their daily routine', 'RISE intervention']","['cognitive frailty status and secondary outcome include physical function, cognitive performance, nutritional status, psychosocial status and quality of life which are obtained during baseline screening and subsequent follow ups']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037440', 'cui_str': 'Social services'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0608547,"Following the rapid increase of the aging population, health promotion and prevention of physical disability and dementia in older persons are essential for healthy aging.","[{'ForeName': 'Resshaya Roobini', 'Initials': 'RR', 'LastName': 'Murukesu', 'Affiliation': 'Physiotherapy Programme and Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Devinder Kaur Ajit', 'Initials': 'DKA', 'LastName': 'Singh', 'Affiliation': 'Physiotherapy Programme and Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Dietetic Program and Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ponnusamy', 'Initials': 'P', 'LastName': 'Subramaniam', 'Affiliation': 'Health Psychology Programme and Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}]",Frontiers in public health,['10.3389/fpubh.2020.00471']
2579,33015085,"Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study.","Background:  Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China.  Purpose:  To evaluate the efficacy and safety of Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medicine formula, combined with methotrexate (MTX) in the treatment of patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF).  Methods:  This pilot study was a monocenter, open-label, randomized controlled trial with two parallel arms. Ninety patients with active RA were randomly allocated to receive either HQT at a dose of 250 ml twice daily or LEF at a dose of 20 mg once daily, and all participants received MTX at a dose of 10-15 mg once weekly. The primary efficacy endpoint was the proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20) after a 24-week treatment.  Results:  84.4% (76/90) patients completed the 24-week observation. In the intention-to-treat analysis, the percentage values of patients achieving the ACR20 response criteria were 72.1% (31/43) in MTX + HQT group and 74.4% (32/43) in MTX + LEF group ( p  = 0.808). No significant difference was observed in other parameters, including ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate. The results of the per-protocol analysis showed consistency with those of the intention-to-treat analysis. The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively,  p  = 0.613). The frequency of adverse events was similar in both groups (11 cases in the MTX + HQT and 17 cases in the MTX + LEF,  p  > 0.05).  Conclusions:  In patients with active RA, treatment with the combination of HQT and MTX was associated with improvement in signs, symptoms, and physical function. With a beneficial clinical response and acceptable tolerability, HQT or other Chinese medicine formula may be a good therapeutic option in combination with MTX for RA treatment.  Trial registration:  Chinese Clinical Trails Registry, ChiCTR-INR-16009031, Registered on 15th August 2016, http://www.chictr.org.cn/enindex.aspx.",2020,"The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively,  p  = 0.613).","['patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF', 'Patients With Active Rheumatoid Arthritis', 'Ninety patients with active RA']","['MTX + LEF', 'methotrexate (MTX', 'LEF', 'MTX + HQT', 'Leflunomide', 'MTX', 'HQT and MTX', 'Huayu-Qiangshen-Tongbi (HQT) decoction', 'Methotrexate', 'HQT', 'Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction']","['proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20', 'frequency of adverse events', 'signs, symptoms, and physical function', 'efficacy and safety', 'ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.199877,"The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively,  p  = 0.613).","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Xianghong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Kaixin', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zehao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Guangxi, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ou', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Dongguan Hospital of Traditional Chinese Medicine, Dongguan, China.'}, {'ForeName': 'Zhisheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Guangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Huadu, China.'}, {'ForeName': 'Per-Johan', 'Initials': 'PJ', 'LastName': 'Jakobsson', 'Affiliation': 'Rheumatology Unit, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Qingchun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Runyue', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2020.00484']
2580,33015104,Vaginal Lactoferrin Administration Decreases Oxidative Stress in the Amniotic Fluid of Pregnant Women: An Open-Label Randomized Pilot Study.,"Background:  Oxidative stress (OxS) has been linked to several pregnancy-related complications. Previous studies demonstrated that lactoferrin (LF) has the ability to modulate inflammation, OxS and the immune function. Therefore, we aimed to observe whether vaginal LF administration was able to decrease OxS in the amniotic fluid (AF) of pregnant women undergoing mid-trimester genetic amniocentesis.  Methods:  In this open-label clinical study, 60 pregnant women were divided into three groups: CONTROLS ( n  = 20), not treated with LF; LACTO 4HRS ( n  = 20), treated with LF 4 h prior to amniocentesis; LACTO 12HRS ( n  = 20), treated with LF 12 h prior to amniocentesis. Thiobarbituric acid reactive substances (TBARS), total antioxidant status (TAS) and oxidative stress index (OSI) were measured in AF samples. In addition, the  in vitro  antioxidant activity of LF on a cell line was tested.  Results:  LF decreased the concentration of TBARS in the AF, with LACTO 4HRS demonstrating the lowest value compared with CONTROLS ( P  < 0.0001). LACTO 4HRS had higher TAS and lower OSI than CONTROLS ( P  < 0.0001 for both).  In vitro , LF was effective against the oxidative challenge regardless of the time of pretreatment.  Conclusion:  In conclusion, LF decreased both  in vivo  and  in vitro  OxS. LF administration may represent an intriguing clinical solution as an adjuvant to treat complications of pregnancy related to inflammation and OxS.  Trial Registration:  Clinicaltrials.gov, NCT02695563. Registered 01 March 2016-Retrospectively registered, https://clinicaltrials.gov/show/NCT02695563.",2020,LACTO 4HRS had higher TAS and lower OSI than CONTROLS ( P  < 0.0001 for both).  ,"['60 pregnant women', 'Pregnant Women', 'pregnant women undergoing mid-trimester genetic amniocentesis']","['LF; LACTO 4HRS', 'Vaginal Lactoferrin Administration', 'LF 4 h prior to amniocentesis; LACTO 12HRS', 'lactoferrin (LF', 'vaginal LF administration']","['TAS and lower OSI', 'Thiobarbituric acid reactive substances (TBARS), total antioxidant status (TAS) and oxidative stress index (OSI', 'concentration of TBARS', 'Oxidative Stress']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}]","[{'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",60.0,0.188873,LACTO 4HRS had higher TAS and lower OSI than CONTROLS ( P  < 0.0001 for both).  ,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Trentini', 'Affiliation': 'Section of Medical Biochemistry, Molecular Biology and Genetics, Department of Biomedical and Specialist Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maritati', 'Affiliation': 'Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Rosta', 'Affiliation': 'Section of Medical Biochemistry, Molecular Biology and Genetics, Department of Biomedical and Specialist Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cervellati', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Manfrinato', 'Affiliation': 'Section of Medical Biochemistry, Molecular Biology and Genetics, Department of Biomedical and Specialist Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Hanau', 'Affiliation': 'Section of Medical Biochemistry, Molecular Biology and Genetics, Department of Biomedical and Specialist Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Pantaleo', 'Initials': 'P', 'LastName': 'Greco', 'Affiliation': 'Section of Orthopedics, Obstetrics and Gynecology and Anesthesia and Resuscitation, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Bonaccorsi', 'Affiliation': 'Section of Orthopedics, Obstetrics and Gynecology and Anesthesia and Resuscitation, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Bellini', 'Affiliation': 'Section of Medical Biochemistry, Molecular Biology and Genetics, Department of Biomedical and Specialist Surgical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Contini', 'Affiliation': 'Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}]",Frontiers in medicine,['10.3389/fmed.2020.00555']
2581,33017580,Ultra-low-dose quadruple combination blood pressure lowering therapy in patients with hypertension: The QUARTET randomized controlled trial protocol.,"High blood pressure is the leading cause of preventable morbidity and mortality globally. Many patients remain on single-drug treatment with poor control although guidelines recognize that most require combination therapy for blood pressure control. Our hypothesis is that a single-pill combination of four blood pressure- lowering agents each at a quarter dose may provide a simple, safe and effective blood pressure lowering solution which may also improve long term-adherence. The QUARTET (Quadruple UltrA-low-dose tReaTment for hypErTension) double-blind, active controlled, randomized clinical trial will examine whether ultra-low-dose quadruple combination therapy is more effective than guideline recommended standard care, in lowering blood pressure. QUARTET will enroll 650 participants with high blood pressure, either on no treatment or on monotherapy. Participants will be randomized 1:1 and allocated to intervention therapy of a single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg or to control therapy of a single identical appearing pill containing irbesartan 150 mg. In both arms step up therapy of open-label amlodipine 5mg will be provided if BP is >140/90 at 6weeks. The primary outcome is the difference between groups in the change from baseline in mean unattended automated office systolic blood pressure at 12weeks follow-up. The primary outcome and some secondary outcomes will be assessed at 12weeks, there is an optional 12months extension phase to assess longer term efficacy and tolerability. Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control. QUARTET will therefore provide evidence for the effectiveness and safety of a new paradigm in the management of high blood pressure.",2020,"Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control.","['650 participants with high blood pressure, either on no treatment or on monotherapy', 'patients with hypertension']","['single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg or to control therapy of a single identical appearing pill containing irbesartan 150 mg', 'Ultra-low-dose quadruple combination blood pressure lowering therapy', 'open-label amlodipine', 'ultra-low-dose quadruple combination therapy']","['mean unattended automated office systolic blood pressure', 'optional 12months extension phase to assess longer term efficacy and tolerability']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C4517467', 'cui_str': '0.625'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",650.0,0.288783,"Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control.","[{'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Australia; The George Institute for Global Health, UNSW, Australia. Electronic address: Clara.chow@sydney.edu.au.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Atkins', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Australia; The George Institute for Global Health, UNSW, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, UNSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, UNSW, Australia.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital and University of Western Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'Castle Hill Medical Centre, NSW, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schlaich', 'Affiliation': 'Dobney Hypertension Centre, School of Medicine, University of Western Australia and Royal Perth Hospital.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, UNSW, Australia; Centre for Health Economics Research and Evaluation, University of Technology Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Australia; The George Institute for Global Health, UNSW, Australia.'}]",American heart journal,['10.1016/j.ahj.2020.09.017']
2582,33017615,Effect of Intracavernosal Injection of Prostaglandin E1 on Duration and Rigidity of Erection in Patients with Vasculogenic Erectile Dysfunction: Is it Dose Dependent?,"OBJECTIVE


To assess if the effect of intracavernosal injection (ICI) of prostaglandin E1 (PGE1) on duration and rigidity of erection is dose dependent in patients with different types of vasculogenic erectile dysfunction (ED)?
METHODS


A hundred patients with ED were assigned into 4 groups (n=25/each); group (A) patients with arteriogenic ED, group (B) patients with veno-occlusive ED, group (C) patients with mixed (arteriogenic and veno-occlusive) ED and group (D) patients who have only psychogenic ED (control). After ICI of PGE1 patients were assessed using penile doppler ultrasonography and erection hardness score together with calculation of erection duration. The starting dose of PGE1 was 5μg which was increased to 10µg and 20µg as a maximal dose when needed.
RESULTS


The mean PSV of patients in groups A, B, C and D were 24.38±3.3, 37.74±8.28, 22.24±3.85 and 47.76±6.27 respectively. In group D, 88% have achieved the best response at dose of 5 µg while 5.3%, 21.7% and 0% have achieved the best response at dose of 5µg in groups A, B and C respectively (p<0.05 for each). The rest of patients have required either 10 or 20µg to achieve the best response. Patients in group C have required the highest dose of PGE1 to achieve the best response (p<0.05).
CONCLUSION


Intracavernosal injection of PGE 1  in escalating doses have improved the rigidity and duration of erection in patients with different types of vasculogenic ED. Patients with mixed arteriogenic and veno-occlusive ED have required the highest dose of PGE 1  to achieve the best response.",2020,"Patients in group C have required the highest dose of PGE1 to achieve the best response (p<0.05).
","['Patients with mixed arteriogenic and veno-occlusive ED', 'patients with different types of vasculogenic ED', 'Patients with Vasculogenic Erectile Dysfunction', 'A hundred patients with ED were assigned into 4 groups (n=25/each); group (A) patients with arteriogenic ED, group (B) patients with veno-occlusive ED, group (C) patients with mixed (arteriogenic and veno-occlusive) ED and group (D) patients who have only psychogenic ED (control', 'patients with different types of vasculogenic erectile dysfunction (ED']","['intracavernosal injection (ICI) of prostaglandin E1 (PGE1', 'Intracavernosal Injection of Prostaglandin E1']","['Duration and Rigidity of Erection', 'mean PSV', 'duration and rigidity of erection', 'penile doppler ultrasonography and erection hardness score', 'rigidity and duration of erection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0948238', 'cui_str': 'Psychogenic erectile dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1297890', 'cui_str': 'Injection of prostaglandin'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}]",,0.0311077,"Patients in group C have required the highest dose of PGE1 to achieve the best response (p<0.05).
","[{'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Bassiem', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Iman Y', 'Initials': 'IY', 'LastName': 'Ismail', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Salem', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'El-Sakka', 'Affiliation': 'Department of Urology, Suez Canal University, Ismailia, Egypt. Electronic address: aielsakka@yahoo.com.'}]",Urology,['10.1016/j.urology.2020.09.030']
2583,32957335,Comparison of 2 types of therapeutic exercise: jaw opening exercise and head lift exercise for dysphagic stroke: A pilot study.,"The aim of this study was to investigate the effect of the jaw opening exercise (JOE) on the thickness of the suprahyoid muscle and hyoid bone movement compared with the head lift exercise (HLE) in patients with dysphagia after strokeThis study recruited 30 patients with dysphagia after stroke. The JOE group performed a JOE using a resistance bar. The HLE group performed the traditional HLE. The total intervention duration was 6 weeks. We measured the thickness of the digastric and mylohyoid muscles using ultrasound. Two-dimensional motion analysis of the hyoid bone was performed using Image J software. The Borg rating of the perceived exertion scale was used to assess the intensity level of physical activity during the 2 exercises.Both groups showed a significant increase in the thickness of the digastric and mylohyoid muscles (P < .05). Hyoid bone motion was significantly increased in the anterior and superior movement in both groups (P < .05). After the intervention, there was no significant difference between the 2 groups. The Borg rating of perceived exertion scale for the JOE group was significantly lower than that of the HLE group (P < .05).In conclusion, this study demonstrated that the JOE and the HLE had similar effects with respect to increasing suprahyoid muscle thickness and improving hyoid bone movement. However, the JOE required less perceived exertion than the HLE.",2020,The Borg rating of perceived exertion scale for the JOE group was significantly lower than that of the HLE group (P < .05).In,"['patients with dysphagia after strokeThis study recruited 30 patients with dysphagia after stroke', 'dysphagic stroke']","['HLE', 'traditional HLE', 'jaw opening exercise (JOE', 'JOE', 'head lift exercise (HLE', 'therapeutic exercise: jaw opening exercise and head lift exercise']","['perceived exertion scale', 'intensity level of physical activity', 'thickness of the digastric and mylohyoid muscles', 'suprahyoid muscle thickness', 'Hyoid bone motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0454360', 'cui_str': 'Head lifting exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224155', 'cui_str': 'Digastric muscle structure'}, {'cui': 'C0224159', 'cui_str': 'Structure of mylohyoid muscle'}, {'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0020417', 'cui_str': 'Hyoid bone structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",30.0,0.0214706,The Borg rating of perceived exertion scale for the JOE group was significantly lower than that of the HLE group (P < .05).In,"[{'ForeName': 'Jong Bae', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Occupational Therapy, Sangji University, Wonju, South Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science at Health Sciences Division in DongSeo University, Busan, South Korea.'}, {'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly, Industry, Dongseo University, Busan, South Korea.'}]",Medicine,['10.1097/MD.0000000000022136']
2584,32957348,"Effect of a new Lactobacillus plantarum product, LRCC5310, on clinical symptoms and virus reduction in children with rotaviral enteritis.","BACKGROUND


Rotavirus is one of the most common causes of infantile enteritis. In common enterocolitis, probiotic organisms, including Lactobacilli, are effective in treating diarrhea. A new species, Lactobacillus plantarum (LRCC5310), which was shown to inhibit the adherence and proliferation of rotavirus in the small intestine through animal experiments, was investigated for the efficacy and safety of patients with rotaviral enteritis.
METHODS


LRCC5310 (Group I) and control (Group II) groups consisting of children who were hospitalized for rotaviral enteritis were compared, and the medical records of patients (Group III) who were hospitalized for rotaviral enteritis during the same study period were retrospectively analyzed. Clinical symptoms were compared and stool samples were collected to compare changes in virus multiplication between Groups I and II.
RESULTS


Groups I, II, and III comprised 15, 8, and 27 children, respectively. There were no differences in clinical information among the groups at admission. In Group I, a statistically significant improvement was noted in the number of patients with diarrhea, number of defecation events on Day 3, and total diarrhea period as opposed to Group II (P = .033, P = .003, and P = .012, respectively). The improvement of Vesikari score in Group I was greater than that in the other groups (P = .076, P = .061, and P = .036, respectively). Among rotavirus genotypes, 9 (22.5%) strains and 8 (20.0%) strains belonged to the G9P8 and G1P8 genotypes, respectively. The virus reduction effect, as confirmed via stool specimens, was also greater in Group I. No significant side effects were noted in infants.
CONCLUSION


LRCC5310 improved clinical symptoms, including diarrhea and Vesikari score, and inhibited viral proliferation in rotaviral gastroenteritis.",2020,"In Group I, a statistically significant improvement was noted in the number of patients with diarrhea, number of defecation events on Day 3, and total diarrhea period as opposed to Group II (P = .033, P = .003, and P = .012, respectively).","['LRCC5310 (Group I) and control (Group II) groups consisting of children who were hospitalized for rotaviral enteritis were compared, and the medical records of patients (Group III) who were hospitalized for rotaviral enteritis during the same study period were retrospectively analyzed', 'children with rotaviral enteritis', 'patients with rotaviral enteritis']","['Lactobacillus plantarum (LRCC5310', 'new Lactobacillus plantarum product, LRCC5310']","['Vesikari score', 'side effects', 'clinical symptoms, including diarrhea and Vesikari score', 'number of patients with diarrhea, number of defecation events on Day 3, and total diarrhea period']","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0343363', 'cui_str': 'Viral gastroenteritis due to Rotavirus'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0276177,"In Group I, a statistically significant improvement was noted in the number of patients with diarrhea, number of defecation events on Day 3, and total diarrhea period as opposed to Group II (P = .033, P = .003, and P = .012, respectively).","[{'ForeName': 'Do Young', 'Initials': 'DY', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Chung-Ang University Hospital.'}, {'ForeName': 'Dae Yong', 'Initials': 'DY', 'LastName': 'Yi', 'Affiliation': 'Department of Pediatrics, Chung-Ang University Hospital.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Jo', 'Affiliation': 'Department of Pediatrics, Chung-Ang University Hospital.'}, {'ForeName': 'Yoo Min', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Bucheon.'}, {'ForeName': 'Jong-Hwa', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Microbiology, Chung-Ang University College of Medicine.'}, {'ForeName': 'Wonyong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Microbiology, Chung-Ang University College of Medicine.'}, {'ForeName': 'Mi Ri', 'Initials': 'MR', 'LastName': 'Park', 'Affiliation': 'Lotte R&D Center, Seoul, Republic of Korea.'}, {'ForeName': 'Seok Min', 'Initials': 'SM', 'LastName': 'Yoon', 'Affiliation': 'Lotte R&D Center, Seoul, Republic of Korea.'}, {'ForeName': 'Yunsik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Lotte R&D Center, Seoul, Republic of Korea.'}, {'ForeName': 'Siyoung', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Lotte R&D Center, Seoul, Republic of Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, Chung-Ang University Hospital.'}]",Medicine,['10.1097/MD.0000000000022192']
2585,31056681,Quantitative myocardial perfusion positron emission tomography and caffeine revisited with new insights on major adverse cardiovascular events and coronary flow capacity.,"AIMS


To evaluate effects of caffeine on quantitative myocardial perfusion by positron emission tomography (PET) and associated major adverse cardiovascular events (MACE).
METHODS AND RESULTS


Serum caffeine was measured for all 6087 PETs with 328 positive results (5.4%). Paired caffeine positive/negative PETs (84 patients for dipyridamole with median caffeine 1.6 mg/L, and additional 25 volunteers for regadenoson with median caffeine 7.4 mg/L) were compared for quantitative perfusion. Multivariate regression analysis for associations among caffeine, clinical/imaging variables, predicted caffeine probability was performed. MACEs were followed up to 9 years after PETs. For caffeine vs. no caffeine, respectively, stress flow was 1.74 ± 0.55 vs. 2.14 ± 0.53 for dipyridamole and 1.82 ± 0.61 vs. 2.33 ± 0.49 mL/min/g for regadenoson, and coronary flow reserve (CFR) was 2.26 ± 0.67 vs. 2.67 ± 0.72 for dipyridamole and 1.84 ± 0.33 vs. 2.31 ± 0.41 for regadenoson (all P < 0.001). Subjects were reclassified from high-risk CFR ≤2.0 with caffeine to low-risk CFR >2.0 without caffeine in 66.7% and 80% of dipyridamole and regadenoson caffeine-no-caffeine pairs, respectively. While relative images showed no differences, caffeine significantly altered coronary flow capacity (CFC) to false negative and false positive severity in 2.1% and 5.5% of the 328 caffeine positives, respectively (0.1% and 0.3% of 6087 PETs) but without change in severity guided management in most patients (92.4% of 328 caffeine or 99.6% of total 6087 PETs).
CONCLUSION


Even low serum caffeine levels reduce quantitative perfusion during vasodilatory stress with false positive or false negative results minimized by empathic instruction, CFC analysis or repeat PET after strict caffeine abstention for definitive individualized risk stratification and management.",2019,"While relative images showed no differences, caffeine significantly altered coronary flow capacity (CFC) to false negative and false positive severity in 2.1% and 5.5% of the 328 caffeine positives, respectively (0.1% and 0.3% of 6087 PETs) but without change in severity guided management in most patients (92.4% of 328 caffeine or 99.6% of total 6087 PETs).
",[],"['Paired caffeine positive/negative PETs', 'caffeine', 'caffeine vs. no caffeine', 'positron emission tomography (PET']","['stress flow', 'severity guided management', 'coronary flow reserve (CFR', 'coronary flow capacity (CFC) to false negative and false positive severity', 'Serum caffeine']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]",6087.0,0.0221795,"While relative images showed no differences, caffeine significantly altered coronary flow capacity (CFC) to false negative and false positive severity in 2.1% and 5.5% of the 328 caffeine positives, respectively (0.1% and 0.3% of 6087 PETs) but without change in severity guided management in most patients (92.4% of 328 caffeine or 99.6% of total 6087 PETs).
","[{'ForeName': 'Danai', 'Initials': 'D', 'LastName': 'Kitkungvan', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Linh', 'Initials': 'L', 'LastName': 'Bui', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Nils P', 'Initials': 'NP', 'LastName': 'Johnson', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Monica B', 'Initials': 'MB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Roby', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Pimprapa', 'Initials': 'P', 'LastName': 'Vejpongsa', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Asim K', 'Initials': 'AK', 'LastName': 'Babar', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Madjid', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Nacimbene', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'DeGolovine', 'Affiliation': 'Division of Renal Disease and Hypertension, Department of Medicine, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}, {'ForeName': 'K Lance', 'Initials': 'KL', 'LastName': 'Gould', 'Affiliation': 'Division of Cardiology and Weatherhead PET Center, McGovern Medical School, UT Health, 6431 Fannin St., and Memorial Hermann Hospital, 6411 Fannin St., Houston, TX, USA.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez080']
2586,31411495,Are Pre-Ascent Low-Altitude Saliva Cortisol Levels Related to the Subsequent Acute Mountain Sickness Score? Observations from a Field Study.,"Background:  The associations among cortisol levels, body water status, and acute mountain sickness (AMS) remain unclear. We investigated associations between AMS prevalence and severity with resting saliva cortisol levels at low altitude (LA) and high altitude (HA) and with fluid balance during a HA stay.  Methods:  Twenty-two physically fit and healthy participants (12 women, 10 men) were transported to HA (Testa Grigia, 3480 m). In the late afternoon at LA, on the next day 3-4 hours after arrival at HA and in the morning after an overnight stay, heart rate, oxygen saturation, and systolic and diastolic blood pressures were measured in a sitting position after 10 minutes of rest; cortisol levels were quantified in saliva samples taken pre-ascent and 3-4 hours after arrival at HA. AMS was scored with the 1993 Lake Louise Score (LLS, cut-off ≥3). Urine volume and fluid and food intake were recorded during the altitude stay.  Results:  Pre-ascent cortisol levels were associated with fluid retention during the altitude stay ( r 2  = 0.33,  p  < 0.05) and both were positively related to the LLS ( r 2  = 0.49 and  r 2  = 0.26,  p  < 0.05, respectively).  Conclusions:  In conclusion, resting LA cortisol levels and fluid retention upon rapid exposure to altitude seem to be associated with AMS. This suggests a potential link among cortisol homeostasis, fluid balance, and AMS risk.",2019,"Pre-ascent cortisol levels were associated with fluid retention during the altitude stay ( r 2  = 0.33,  p  < 0.05) and both were positively related to the LLS ( r 2  = 0.49 and  r 2  = 0.26,  p  < 0.05, respectively).  ","['Methods:  Twenty-two physically fit and healthy participants (12 women, 10 men) were transported to HA (Testa Grigia, 3480\u2009m']",[],"['Urine volume and fluid and food intake', 'cortisol levels, body water status, and acute mountain sickness (AMS', 'AMS prevalence and severity with resting saliva cortisol levels at low altitude (LA) and high altitude (HA', 'heart rate, oxygen saturation, and systolic and diastolic blood pressures', 'Pre-ascent cortisol levels', 'AMS', 'resting LA cortisol levels and fluid retention']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",[],"[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0238618', 'cui_str': 'Low altitude'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention'}]",22.0,0.0213418,"Pre-ascent cortisol levels were associated with fluid retention during the altitude stay ( r 2  = 0.33,  p  < 0.05) and both were positively related to the LLS ( r 2  = 0.49 and  r 2  = 0.26,  p  < 0.05, respectively).  ","[{'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Bernatzky', 'Affiliation': 'Department of Ecology and Evolution, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Burtscher', 'Affiliation': 'Laboratory of Molecular and Chemical Biology of Neurodegeneration, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rainer', 'Affiliation': 'General Practitioner, Salzburg, Austria.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Kayser', 'Affiliation': 'Institute of Sport Sciences, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Innsbruck, Austria.'}]",High altitude medicine & biology,['10.1089/ham.2019.0034']
2587,33021143,Objective analysis of language use in cognitive-behavioral therapy: associations with symptom change in adults with co-occurring substance use disorders and posttraumatic stress.,"Substance use disorders (SUD) commonly co-occur with posttraumatic stress disorder (PTSD) symptoms, and the comorbidity is prevalent and difficult-to-treat. Few studies have objectively analyzed language use in psychotherapy as a predictor of treatment outcomes. We conducted a secondary analysis of patient language use during cognitive-behavioral therapy (CBT) in a randomized clinical trial, comparing a novel, integrated CBT for PTSD/SUD with standard CBT for SUD. Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD. We analyzed transcripts of a single, matched session across both treatment conditions, using the Linguistic Inquiry and Word Count (LIWC) program. The program measures language use across multiple categories. Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words. Further, exploratory analyses indicated an association between usage of cognitive processing words and clinician-observed reduction in PTSD symptoms, regardless of treatment condition. Our results suggest that language use during therapy may provide a window into mechanisms active in therapy.",2020,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","['Participants included 37 treatment-seeking, predominantly African-American adults with SUD and at least four symptoms of PTSD', 'adults with co-occurring substance use disorders and posttraumatic stress']","['language use in cognitive-behavioral therapy', 'patient language use during cognitive-behavioral therapy (CBT']",['positive emotion words'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",37.0,0.0173698,"Compared to standard CBT for SUD, patients in the novel, integrated CBT for PTSD/SUD used more negative emotion words, partially consistent with our hypothesis, but less positive emotion words.","[{'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Jennings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Soder', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center , Houston, TX, USA.'}, {'ForeName': 'Anka A', 'Initials': 'AA', 'LastName': 'Vujanovic', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1819865']
2588,33021146,A Group-Based Walking Study to Enhance Physical Activity Among Older Adults: The Role of Social Engagement.,"OBJECTIVES.


The aim of this study was to explore social engagement and social comparisons as mechanisms to increase physical activity among older adults.
METHODS.


Participants (N = 60, mean age = 65.7) were randomly assigned to one of two conditions. Participants in the treatment condition used the application to track their daily walking steps and interact via text messages with their group members for 4 weeks. Participants in the control group used the application only to track their own walking steps. Outcome variables included mean weekly steps, exercise self-efficacy, and social engagement.
RESULTS.


The results revealed that participants in the experimental condition significantly increased their mean weekly steps and social engagement from the pretest to the posttest whereas the control group did not. These effects were maintained at the 1-month follow up.
DISCUSSION.


The study expands our understanding of the motivational role of social engagement and social comparison in increasing PA among older adults.",2020,Participants in the treatment condition used the application to track their daily walking steps and interact via text messages with their group members for 4 weeks.,"['older adults', 'Participants (N = 60, mean age = 65.7', 'Older Adults']",[],"['mean weekly steps and social engagement', 'mean weekly steps, exercise self-efficacy, and social engagement', 'Physical Activity', 'physical activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",60.0,0.0135589,Participants in the treatment condition used the application to track their daily walking steps and interact via text messages with their group members for 4 weeks.,"[{'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Human Development and Family Studies, Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, USA.'}]",Research on aging,['10.1177/0164027520963613']
2589,33021443,Randomized Controlled Trial of Scrotal Versus Inguinal Orchidopexy on Postoperative Pain.,"INTRODUCTION AND OBJECTIVE


To compare the impact of orchidopexy approach(scrotal[SO]vs.inguinal[IO]) on analgesic requirements, postoperative pain scores and complication rates.
METHODS


A superiority RCT including boys 10-95 months of age at surgery, diagnosed with palpable undescended testis(UDT) was conducted. Patients with non-palpable or bilateral UDT, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded. Block randomization with 1:1 allocation ratio and a standardized anesthesia protocol were employed. The primary outcome was postoperative pain and analgesic use in hospital and at home using validated pain scales(FLACC,CHEOPS,PPPM,TPPPS). Secondary outcomes included operative time(OpT), conversion and success rates, and complications. An intention to treat protocol(ITT) was followed.
RESULTS


We enrolled 173 patients, 12 withdrew. Of the161 patients who completed follow-up, 80 had SO and 81 IO. In-hospital use of ibuprofen(p=0.02) and acetaminophen(p<0.01), as well as FLACC(p<0.01) and CHEOPS(p=0.04) pain scores were slightly higher in IO patients. No difference in mean OpT and median at-home administration of analgesic was noted. The conversion rate was 24%(19/80). Of these, 13(68%) had canalicular testes. The overall complication rate was 4%(6/161):1 testicular atrophy, 3 re-ascents, 2 wound infections. Of these, 5 underwent SO and 1 had IO(wound infection).
CONCLUSIONS


Even though in-hospital mean postoperative pain scores and analgesic consumption were slightly lower for SO patients, the pain levels were mild across all scales. Median at-home analgesic use and pain scores were similar for both groups, as well as OpT and complication rates. SO is an effective alternative to IO for low-lying UDT, as 68%of those that needed conversion were canalicular testes.",2020,"In-hospital use of ibuprofen(p=0.02) and acetaminophen(p<0.01), as well as FLACC(p<0.01) and CHEOPS(p=0.04) pain scores were slightly higher in IO patients.","['Of the161 patients who completed follow-up, 80 had SO and 81 IO', 'Patients with non-palpable or bilateral UDT, previous inguinal surgery on the ipsilateral side and concurrent procedures were excluded', 'We enrolled 173 patients, 12 withdrew', 'boys 10-95 months of age at surgery, diagnosed with palpable undescended testis(UDT']","['acetaminophen(p<0.01', 'orchidopexy approach(scrotal[SO]vs.inguinal[IO', 'Scrotal Versus Inguinal Orchidopexy']","['Median at-home analgesic use and pain scores', 'analgesic requirements, postoperative pain scores and complication rates', 'operative time(OpT), conversion and success rates, and complications', 'pain levels', 'postoperative pain and analgesic use in hospital and at home using validated pain scales(FLACC,CHEOPS,PPPM,TPPPS', 'overall complication rate', 'Postoperative Pain', 'CHEOPS(p=0.04) pain scores', 'postoperative pain scores and analgesic consumption', 'mean OpT and median at-home administration of analgesic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522499', 'cui_str': 'Palpable'}, {'cui': 'C0431663', 'cui_str': 'Undescended testes - bilateral'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021358', 'cui_str': 'Structure of inferior colliculus of corpora quadrigemina'}]","[{'cui': 'C0194907', 'cui_str': 'Orchidopexy'}, {'cui': 'C0036471', 'cui_str': 'Scrotal'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}]",173.0,0.371553,"In-hospital use of ibuprofen(p=0.02) and acetaminophen(p<0.01), as well as FLACC(p<0.01) and CHEOPS(p=0.04) pain scores were slightly higher in IO patients.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Braga', 'Affiliation': 'McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001379']
2590,33021466,Validation of the Colon Life nomogram in patients with refractory metastatic colorectal cancer enrolled in the RECOURSE trial.,"BACKGROUND


The RECOURSE trial (Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies) demonstrated an overall survival (OS) benefit of trifluridine/tipiracil (FTD/TPI) vs placebo in refractory metastatic colorectal cancer (mCRC). Given the limited benefit of later line treatments, we developed the Colon Life nomogram to assess the 12-week death probability in the refractory setting.
METHODS


This post hoc analysis of RECOURSE included patients with available data to calculate the nomogram score: Eastern Cooperative Oncology Group Performance Status, primary tumor resection, lactate dehydrogenase, and peritoneal metastases. The nomogram calibration was assessed by calibration plots and C-index. The nomogram prognostic and predictive ability was assessed by Cox model analyses and the nomogram score predictive value was explored according to the cutoff identified at maximum value of the Youden index in time-dependent receiver operating characteristic curve analysis.
RESULTS


Overall, 251 trial patients were evaluable: 90 in the placebo arm and 161 in the FTD/TPI arm. The calibration was optimal in the placebo arm (C-index 0.807) and suboptimal in the FTD/TPI arm (0.657). The cutoff of the nomogram score of 23 showed the best discriminative ability for 12-week OS (hazard ratio 3.46, 95% confidence interval 2.17-5.51 for scores 40 vs 15) and had maximum value of the Youden index (0.381). Median OS and 3-month PFS were 9.0 vs 7.5 months and 39.3% vs 5.2%, respectively, for FTD/TPI vs placebo in the low-risk group (score <23) and 4.8 vs 3.4 months and 22.3% vs 9.8% in the high-risk group (score ⩾23) (interaction NS).
CONCLUSION


The Colon Life nomogram is an accurate tool for estimating life expectancy in refractory mCRC. The benefit of FTD/TPI was independent of the predicted risk of early death.",2020,The calibration was optimal in the placebo arm (C-index 0.807) and suboptimal in the FTD/TPI arm (0.657).,"['refractory metastatic colorectal cancer (mCRC', 'patients with refractory metastatic colorectal cancer', '251 trial patients were evaluable: 90 in the placebo arm and 161 in the FTD/TPI arm', 'included patients with available data to calculate the nomogram score: Eastern Cooperative Oncology Group Performance Status, primary tumor resection, lactate dehydrogenase, and peritoneal metastases', 'Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies']","['trifluridine/tipiracil (FTD/TPI) vs placebo', 'TAS-102', 'placebo']",['Median OS and 3-month PFS'],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1451803', 'cui_str': 'TAS-102'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.174029,The calibration was optimal in the placebo arm (C-index 0.807) and suboptimal in the FTD/TPI arm (0.657).,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manca', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Randon', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Corti', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Tumori,['10.1177/0300891620960808']
2591,33021481,Effectiveness of a Participatory and Interactive Virtual Reality Intervention in Patients With Social Anxiety Disorder: Longitudinal Questionnaire Study.,"BACKGROUND


Social anxiety disorder (SAD) is characterized by excessive fear of negative evaluation and humiliation in social interactions and situations. Virtual reality (VR) treatment is a promising intervention option for SAD.
OBJECTIVE


The purpose of this study was to create a participatory and interactive VR intervention for SAD. Treatment progress, including the severity of symptoms and the cognitive and emotional aspects of SAD, was analyzed to evaluate the effectiveness of the intervention.
METHODS


In total, 32 individuals with SAD and 34 healthy control participants were enrolled in the study through advertisements for online bulletin boards at universities. A VR intervention was designed consisting of three stages (introduction, core, and finishing) and three difficulty levels (easy, medium, and hard) that could be selected by the participants. The core stage was the exposure intervention in which participants engaged in social situations. The effectiveness of treatment was assessed through Beck Anxiety inventory (BAI), State-Trait Anxiety Inventory (STAI), Internalized Shame Scale (ISS), Post-Event Rumination Scale (PERS), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Brief-Fear of Negative Evaluation Scale (BFNE), and Liebowitz Social Anxiety Scale (LSAS).
RESULTS


In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process. Compared with the healthy control group before treatment, the SAD group showed significantly higher scores on all scales (P<.001), and these significant differences persisted even after treatment (P<.001). In the comparison between the VR treatment responder and nonresponder subgroups, there was no significant difference across the course of the VR session.
CONCLUSIONS


These findings indicated that a participatory and interactive VR intervention had a significant effect on alleviation of the clinical symptoms of SAD, confirming the usefulness of VR for the treatment of SAD. VR treatment is expected to be one of various beneficial therapeutic approaches in the future.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS) KCT0003854; https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=13508.",2020,"In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process.","['Patients With Social Anxiety Disorder', '32 individuals with SAD and 34 healthy control participants were enrolled in the study through advertisements for online bulletin boards at universities', 'Social anxiety disorder (SAD']","['Virtual reality (VR) treatment', 'participatory and interactive VR intervention', 'Participatory and Interactive Virtual Reality Intervention']","['SPS', 'ISS', 'BAI', 'STAI-Trait', 'BFNE', 'Beck Anxiety inventory (BAI), State-Trait Anxiety Inventory (STAI), Internalized Shame Scale (ISS), Post-Event Rumination Scale (PERS), Social Phobia Scale (SPS), Social Interaction Anxiety Scale (SIAS), Brief-Fear of Negative Evaluation Scale (BFNE), and Liebowitz Social Anxiety Scale (LSAS', 'severity of symptoms and the cognitive and emotional aspects of SAD', 'LSAS', 'alleviation of the clinical symptoms of SAD', 'KSAD', 'PERS-negative']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0243152', 'cui_str': 'emotional aspects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",32.0,0.0147694,"In the SAD group, scores on the BAI (F=4.616, P=.009), STAI-Trait (F=4.670, P=.004), ISS (F=6.924, P=.001), PERS-negative (F=1.008, P<.001), SPS (F=8.456, P<.001), BFNE (F=6.117, P=.004), KSAD (F=13.259, P<.001), and LSAS (F=4.103, P=.009) significantly improved over the treatment process.","[{'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chungnam National University Sejong Hospital, Sejong, Republic of Korea.'}, {'ForeName': 'Dooyoung', 'Initials': 'D', 'LastName': 'Jung', 'Affiliation': 'Department of Human Factors Engineering, Ulsan National Institute of Science and Technology, Ulsan, Republic of Korea.'}, {'ForeName': 'Ji-Won', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Heon-Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Sungkil', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Software, Sungkyunkwan University, Suwon, Republic of Korea.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Kim', 'Affiliation': 'Digital Experience Laboratory, Department of Computer Science and Engineering, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Chung-Yean', 'Initials': 'CY', 'LastName': 'Cho', 'Affiliation': 'Department of Film & Multimedia, Korea National University of Arts, Seoul, Republic of Korea.'}, {'ForeName': 'Seungmoon', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Computer Science and Engineering, Pohang University of Science and Technology, Pohang, Republic of Korea.'}, {'ForeName': 'Seung-Moo', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Film & Multimedia, Korea National University of Arts, Seoul, Republic of Korea.'}, {'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry, College of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/23024']
2592,33021484,Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial.,"BACKGROUND


African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols.
OBJECTIVE


This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs.
METHODS


A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894).
RESULTS


At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
CONCLUSIONS


These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints.",2020,"The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
","['African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs', '64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs', 'Prehypertensive Adults']","['breathing awareness meditation (BAM', 'Smartphone Meditation App']","['sleep fragmentation', 'longer sleep duration', 'Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring', 'lower fragmentation, longer sleep duration, and higher efficiency', 'sleep efficiency and quality as well as the PSQI global value', 'sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep', 'average sleep', 'Sleep quality']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",64.0,0.0328084,"The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03).
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Sieverdes', 'Affiliation': 'College of Charleston, Health and Human Performance, Charleston, SC, United States.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Treiber', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kline', 'Affiliation': 'Department of Health & Physical Activity, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Brunner-Jackson', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sox', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Cain', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Swem', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, United States.'}]",JMIR formative research,['10.2196/20501']
2593,33021488,Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial.,"BACKGROUND


Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.
OBJECTIVE


Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.
METHODS


A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.
RESULTS


A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.
CONCLUSIONS


The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.",2020,"The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
","['556 adult smokers (aged 18\u2009years or older) smoking at least 5 cigarettes a day for the past year were recruited', 'Adult Smokers', '530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit', 'n=277; control', '556 participants were randomized (treatment', 'Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom']","['smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities', 'Digital Therapeutic Intervention', 'carbon monoxide device', 'nicotine replacement therapy', 'digital therapeutic intervention', 'carbon monoxide measurement (carbon monoxide <10 ppm']","['self-reported 7-day point prevalence abstinence at 4 weeks post quit date', 'carbon monoxide readings']","[{'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement'}, {'cui': 'C0439187', 'cui_str': 'ppm'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",556.0,0.371296,"The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.
","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Webb', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sarrah', 'Initials': 'S', 'LastName': 'Peerbux', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smittenaar', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sarim', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Sherwani', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Maroof', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'MacRae', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Puri', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Sangita', 'Initials': 'S', 'LastName': 'Bhalla', 'Affiliation': 'Digital Therapeutics Inc, San Francisco, CA, United States.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Majeed', 'Affiliation': 'Imperial College London, London, United Kingdom.'}]",JMIR mental health,['10.2196/22833']
2594,33021490,"BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments.","BACKGROUND


Information and communication technology may provide domiciliary care programs with continuity of care. However, evidence about the effectiveness and cost-effectiveness of information and communication technology in the context of integrated care models is relatively scarce.
OBJECTIVE


The objective of our study was to provide evidence on the clinical effectiveness and cost-effectiveness of the BeyondSilos project for patients enrolled in the Badalona city pilot site in Spain.
METHODS


A quasi-experimental study was used to assess the cost-effectiveness of information and communication technology-enhanced integration of health and social care, including the third sector (intervention), compared to basic health and social care coordination (comparator). The study was conducted in Badalona between 2015 and 2016. Participants were followed for 8 months.
RESULTS


The study included 198 patients: 98 in the intervention group and 100 in the comparator group. The mean Barthel index remained unchanged in the intervention group (mean change 0.14, 95% CI -4.51 to 4.78; P=.95) but decreased in the comparator group (mean change -3.23, 95% CI -5.34 to -1.11; P=.003). Instrumental Activities of Daily Living significantly decreased in both groups: mean changes of -0.23 (95% CI -0.44 to -0.02; P=.03) and -0.33 (95% CI -0.46 to -0.20; P<.001) in the intervention and comparator groups, respectively. No differences were found in the Geriatric Depression Scale (intervention: mean change 0.28, 95% CI -0.44 to 1.01, P=.44; comparator: mean change -0.29, 95% CI -0.59 to 0.01, P=.06). The intervention showed cost-effectiveness (incremental cost-effectiveness ratio €6505.52, approximately US $7582).
CONCLUSIONS


The information and communication technology-enhanced integrated domiciliary care program was cost-effective. The beneficial effects of this approach strongly rely upon the commitment of the professional staff involved.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03111004; http://clinicaltrials.gov/ct2/show/ NCT03111004.",2020,Instrumental Activities of Daily Living significantly decreased in both groups:,"['patients enrolled in the Badalona city pilot site in Spain', 'Badalona between 2015 and 2016', '198 patients: 98 in the intervention group and 100 in the comparator group', 'Older Patients']","['information and communication technology-enhanced integration of health and social care, including the third sector (intervention), compared to basic health and social care coordination (comparator', 'Telehealth-Enhanced Integrated Care Model']","['Geriatric Depression Scale (intervention', 'clinical effectiveness and cost-effectiveness', 'cost-effectiveness (incremental cost-effectiveness ratio €', 'Instrumental Activities of Daily Living', 'mean Barthel index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",198.0,0.0587592,Instrumental Activities of Daily Living significantly decreased in both groups:,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jiménez', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Daugbjerg', 'Affiliation': 'Graduate School of Health Economics and Management, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Stafylas', 'Affiliation': 'Medical Research & Innovation (HEALTHINK), Thessaloniki, Greece.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'PMV Research Group, Universität zu Köln, Köln, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Empirica Gesellschaft für Kommunikations und Technologieforschung GmbH, Bonn, Germany.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lewis', 'Affiliation': 'International Foundation for Integrated Care, Oxford, United Kingdom.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'da Col', 'Affiliation': 'IGEA Hospital Trieste, Trieste, Italy.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiáñez-Villanueva', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",JMIR medical informatics,['10.2196/20938']
2595,33021547,Effect of Wrist-Ankle Acupuncture on Propofol Dosage in Painless Gastroscopy of Elderly Patients: A Randomized Controlled Trial.,,2020,,['Painless Gastroscopy of Elderly Patients'],"['Wrist-Ankle Acupuncture', 'Propofol Dosage']",[],"[{'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",[],,0.0683118,,"[{'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesia, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesia, the Second Affiliated Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesia, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Endoscopic Center of Digestion, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Acupuncture, Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang, China.'}]",American journal of therapeutics,['10.1097/MJT.0000000000001272']
2596,33021563,"Ambulatory continuous peripheral nerve blocks to treat post-amputation phantom limb pain a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial.","Phantom limb pain is thought to be sustained by reentrant neural pathways which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0-12 weeks. Pretreatment pain scores were similar in both groups, with a median [interquartile range] of 5.0 [4.0, 7.0] for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic versus 4.5 (2.6) in those given placebo (difference (95% CI) 1.3 (0.4, 2.2), P=0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 [0, 5.0] vs. 1.5 [0, 5.0] for the placebo group; there appeared to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.",2020,"Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores.",['enrolled patients who had an upper- or lower-limb amputation and established phantom pain'],"['local anesthetic', '6-day continuous peripheral nerve block', 'placebo', 'ropivacaine or normal saline', 'Ambulatory continuous peripheral nerve blocks']","['global impression of change and less pain-induced physical and emotional dysfunction', 'phantom limb pain', 'average phantom pain severity as measured with a Numeric Rating Scale', 'average phantom limb pain intensity', 'depression scores', 'Pretreatment pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.757738,"Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'Professor, In Residence, Department of Anesthesiology.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Khatibi', 'Affiliation': 'Associate Clinical Professor, Department of Anesthesiology.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Associate Professor, Departments of General Anesthesia and Outcomes Research.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Madison', 'Affiliation': 'Associate Professor, Department of Anesthesiology.'}, {'ForeName': 'Wael Ali', 'Initials': 'WA', 'LastName': 'Sakr Esa', 'Affiliation': 'Assistant Professor, Departments of General Anesthesia and Outcomes Research.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Mariano', 'Affiliation': 'Professor, Department of Anesthesiology, Perioperative and Pain Medicine.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kent', 'Affiliation': 'Assistant Professor, Department of Anesthesiology.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hanling', 'Affiliation': 'Assistant Professor, Department of Anesthesiology.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Michael Cudahy Professor and Chair, Department of OUTCOMES RESEARCH.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Eisenach', 'Affiliation': 'FM James, III Professor, Department of Anesthesiology.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Cohen', 'Affiliation': 'Professor, Department of Anesthesiology.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Staff Biostatistician, Departments of Quantitative Health Sciences and OUTCOMES RESEARCH.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Statistical Programmer II, Departments of Quantitative Health Sciences and OUTCOMES RESEARCH.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Padwal', 'Affiliation': 'Resident, Department of Radiology.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Professor, Departments of General Anesthesia and Outcomes Research.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002087']
2597,33021579,Comparison of Traditional and Rest-Redistribution Sets on Indirect Markers of Muscle Damage Following Eccentric Exercise.,"Merrigan, JJ, Jones, MT, Malecek, J, Padecky, J, Omcirk, D, Xu, N, Peñailillo, L, and Tufano, JJ. Comparison of traditional and rest-redistribution sets on indirect markers of muscle damage following eccentric exercise. J Strength Cond Res XX(X): 000-000, 2020-The purpose was to investigate the effect of rest-redistribution (RR) on muscle damage after eccentric knee extensions. After 2 weeks of eccentric familiarization, 11 resistance-trained men performed 2 work-matched isokinetic unilateral eccentric knee extension protocols at 60°·s using a crossover design, separated by 7 days. Subjects performed 40 repetitions with 285 seconds of rest using traditional sets (TS; 4 sets of 10 with 95 seconds of interset rest) and RR (RR; 20 sets of 2 with 15 seconds of interset rest). Muscle morphology, tensiomyography, range of motion, perceived soreness, and strength were measured before and 0, 24, 48, 72, and 96 hour after RR and TS. There were no protocol × time interactions (p < 0.05). When collapsed across protocol and compared to baseline, echo intensity of the proximal vastus lateralis was 7 ± 9% greater at 0 hour (p = 0.042), echo intensity of the distal vastus lateralis was 6 ± 7% and 9 ± 7% greater at 0 hour (p = 0.048) and 24 hour (p < 0.001), respectively, and passive ROM was 2 ± 1% lower at 48 hour (p = 0.043) after exercise. No other differences existed over time for any other variable. Thus, contrary to concentric performance where RR likely plays a large role in maintaining performance, RR during eccentric isokinetic resistance training does not strongly influence exercise performance and indications of subsequent muscle damage.",2020,There were no protocol × time interactions (p < 0.05).,[],"['eccentric exercise', 'Traditional and Rest-Redistribution Sets', 'rest-redistribution (RR', 'traditional and rest-redistribution sets', 'J Strength Cond Res XX(X', 'eccentric familiarization, 11 resistance-trained men performed 2 work-matched isokinetic unilateral eccentric knee extension protocols']","['passive ROM', 'Muscle morphology, tensiomyography, range of motion, perceived soreness, and strength', 'echo intensity of the distal vastus lateralis']",[],"[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",,0.0677362,There were no protocol × time interactions (p < 0.05).,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Merrigan', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Jones', 'Affiliation': 'School of Kinesiology, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Malecek', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Padecky', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Omcirk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Peñailillo', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae (Finis Terrae University), Santiago, Chile.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, Charles University in Prague, Prague, Czech Republic.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003740']
2598,33021580,Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial.,"Holm, PM, Kemnitz, J, Bandholm, T, Wernbom, M, Schrøder, HM, and Skou, ST. Muscle function tests as supportive outcome measures for performance-based and self-reported physical function in patients with knee osteoarthritis: Exploratory analysis of baseline data from a randomized trial. J Strength Cond Res XX(X): 000-000, 2020-Uncertainty on the role of muscle function in relation to physical function in knee osteoarthritis (KOA) persists. This study aimed to assess the associations between muscle function and performance-based and self-reported physical function in patients with KOA. Physical function in 80 subjects with symptomatic and radiographic KOA was assessed using 40-m fast-paced walk, 30-second chair stand, 9-step stair climb tests, and the subscale activities of daily living from the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL). Measurements of muscle function included leg extension (LE) power, knee extension (KE) torque, and estimated leg press one repetition maximum (LP RM). Associations were investigated using multivariable hierarchical linear regressions adjusted for age, sex, body mass index, self-reported physical activity, and thigh muscle lean area. Leg extension power was significantly associated with 40-m walk, stair climb, and 30-second chair stand, explaining 18, 8, and 3% of additional variance, respectively. Knee extension torque explained 13, 7, 17, and 7% of additional variance in the 40-m walk, stair climb, 30-second chair stand, and KOOS-ADL, respectively. Leg press one repetition maximum explained 11% of additional variance in the 30-second chair stand. In conclusion, LE power was the best explanatory variable for performance on the 40-m walk and stair climb tests, whereas KE torque best explained chair stand performance. Only KE torque was associated with KOOS-ADL. Our results highlight the importance of selecting supportive muscle function tests based on the specific physical function and suggest that other factors may be more important for certain physical function outcomes. Level of significance p < 0.05. Trial identifier: NCT03215602.",2020,"In conclusion, LE power was the best explanatory variable for performance on the 40-m walk and stair climb tests, whereas KE torque best explained chair stand performance.","['patients with knee osteoarthritis', '80 subjects with symptomatic and radiographic KOA', 'patients with KOA', 'Patients With Knee Osteoarthritis']",['J Strength Cond Res XX(X'],"['subscale activities of daily living from the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL', 'Leg extension power', 'KE torque best explained chair stand performance', 'Performance-Based and Self-Reported Physical Function', 'Holm, PM, Kemnitz, J, Bandholm, T, Wernbom, M, Schrøder, HM, and Skou, ST', '40-m walk, stair climb, 30-second chair stand, and KOOS-ADL', 'performance-based and self-reported physical function', 'leg extension (LE) power, knee extension (KE) torque, and estimated leg press one repetition maximum (LP RM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",80.0,0.0560749,"In conclusion, LE power was the best explanatory variable for performance on the 40-m walk and stair climb tests, whereas KE torque best explained chair stand performance.","[{'ForeName': 'Pætur Mikal', 'Initials': 'PM', 'LastName': 'Holm', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kemnitz', 'Affiliation': 'Institute of Anatomy & Department of Imaging and Functional Musculoskeletal Research, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine & Rehabilitation Research, Copenhagen (PMR-C), Copenhagen University Hospital, Amager and Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wernbom', 'Affiliation': 'Department of Food and Nutrition and Sport Science, Center for Health and Performance, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Henrik Morville', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Orthopaedic Surgery, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark.'}, {'ForeName': 'Søren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003840']
2599,33021583,"The Effects of a Novel Quadrupedal Movement Training Program on Functional Movement, Range of Motion, Muscular Strength, and Endurance.","Buxton, JD, Prins, PJ, Miller, MG, Moreno, A, Welton, GL, Atwell, AD, Talampas, TR, and Elsey, GE. The effects of a novel quadrupedal movement training program on functional movement, range of motion, muscular strength, and endurance. J Strength Cond Res XX(X): 000-000, 2020-Quadrupedal movement training (QMT) is a form of bodyweight training incorporating animal poses, transitions, and crawling patterns to reportedly improve fitness. This type of training may improve multiple facets of fitness, unfortunately, little evidence exists to support commercial claims and guide practitioners in the best use of QMT. Therefore, the purpose of this study was to assess the impact of a commercially available QMT program on functional movement, dynamic balance, range of motion, and upper body strength and endurance. Forty-two active college-age (19.76 ± 2.10 years) subjects (males = 19, females = 23) were randomly assigned to a QMT (n = 21) or control (CON) (n = 21) group for 8 weeks. Quadrupedal movement training consisted of 60-minute classes performed 2×·wk in addition to regular physical activity. Active range of motion, Functional Movement Screen (FMS), Y-Balance Test (YBT), handgrip strength, and push-up endurance were assessed before and after the intervention. The QMT group showed significantly greater improvements than the CON group in FMS composite score (1.62 ± 1.53 vs. 0.33 ± 1.15, p = 0.004) and FMS advanced movements (0.81 ± 0.87 vs. 0.01 ± 0.71, p = 0.002) and fundamental stability (0.57 ± 0.75 vs. 0.05 ± 0.50, p = 0.011), along with hip flexion, hip lateral rotation, and shoulder extension (p < 0.05). No significant differences between groups were observed for dynamic balance or upper body strength and endurance. Our results indicate that QMT can improve FMS scores and various active joint ranges of motion. Quadrupedal movement training is a viable alternative form of training to improve whole-body stabilization and flexibility.",2020,No significant differences between groups were observed for dynamic balance or upper body strength and endurance.,"['Forty-two active college-age (19.76 ± 2.10 years) subjects (males = 19, females = 23']","['Novel Quadrupedal Movement Training Program', 'Quadrupedal movement training', 'J Strength Cond Res XX(X', '2020-Quadrupedal movement training (QMT', 'QMT program', 'QMT', 'control (CON', 'novel quadrupedal movement training program', 'CON']","['Buxton, JD, Prins, PJ, Miller, MG, Moreno, A, Welton, GL, Atwell, AD, Talampas, TR, and Elsey, GE', 'FMS composite score', 'FMS scores and various active joint ranges of motion', 'fundamental stability', 'hip flexion, hip lateral rotation, and shoulder extension', 'functional movement, dynamic balance, range of motion, and upper body strength and endurance', 'Functional Movement, Range of Motion, Muscular Strength, and Endurance', 'Active range of motion, Functional Movement Screen (FMS), Y-Balance Test (YBT), handgrip strength, and push-up endurance', 'functional movement, range of motion, muscular strength, and endurance', 'dynamic balance or upper body strength and endurance', 'FMS advanced movements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600587', 'cui_str': 'In Situ Labeling, Primed'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",42.0,0.015016,No significant differences between groups were observed for dynamic balance or upper body strength and endurance.,"[{'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Buxton', 'Affiliation': 'Department of Exercise Science, Grove City College, Grove City, Pennsylvania.'}, {'ForeName': 'Philp J', 'Initials': 'PJ', 'LastName': 'Prins', 'Affiliation': 'Department of Exercise Science, Grove City College, Grove City, Pennsylvania.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'Department of Human Performance and Health Education, Western Michigan University, Kalamazoo, Michigan.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Moreno', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, Michigan.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Welton', 'Affiliation': 'Department of Psychology, Grove City College, Grove City, Pennsylvania.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Atwell', 'Affiliation': 'Department of Exercise Science, Grove City College, Grove City, Pennsylvania.'}, {'ForeName': 'Tirzah R', 'Initials': 'TR', 'LastName': 'Talampas', 'Affiliation': 'Department of Exercise Science, Grove City College, Grove City, Pennsylvania.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Elsey', 'Affiliation': 'Department of Exercise Science, Grove City College, Grove City, Pennsylvania.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003818']
2600,33021585,Vitamins C and E Associated With Cryotherapy in the Recovery of the Inflammatory Response After Resistance Exercise: A Randomized Clinical Trial.,"de Brito, E, Teixeira, AdO, Righi, NC, Paulitcth, FdS, da Silva, AMV, and Signori, LU. Vitamins C and E associated with cryotherapy in the recovery of the inflammatory response after resistance exercise: A randomized clinical trial. J Strength Cond Res XX(X): 000-000, 2019-The objective of this research was to compare the effects of cryotherapy associated with vitamins (C and E) on the recovery of the inflammatory response from the resistance exercise (RE) session of untrained volunteers. Fourteen subjects (26.2 ± 5 years old, 25.8 ± 3 kg·m) underwent 4 sessions of RE with different forms of recovery. The RE consisted of 4 sets of 10 maximal repetitions for each exercise (extensor bench, squat, and leg press). The recoveries were randomized and comprised the passive (control), with vitamins C (1 g) and E (800 UI) supplementation 40 minutes before exercise, with cryotherapy (immersion in water 15° C for 10 minutes), and the association (vitamins and cryotherapy). Hemogram, inflammatory markers (C-reactive protein and creatine kinase [CK]), and parameters of oxidative stress (lipid peroxidation [LPO] and antioxidant capacity against radical peroxyl) were evaluated before (baseline) and after (0, 30, and 120 minutes) the RE sessions. Muscle pain (primary outcome) was evaluated 24 hours after exercise. C-reactive protein (p = 0.010) and LPO (p < 0.001) increased (120 minutes) only in passive recovery. Recovery with cryotherapy (30 minutes), with vitamins and the association (0 and 30 minutes) delayed increases in CK (p < 0.001). Antioxidant capacity against radical peroxyl increased (30 minutes) only in recovery with the association (p < 0.011). The pain decreased in the recoveries with cryotherapy and association (p < 0.001). The association of vitamins (C and E) with cryotherapy attenuated the inflammatory response and pain, favoring recovery after an acute RE session.",2020,Antioxidant capacity against radical peroxyl increased (30 minutes) only in recovery with the association (p < 0.011).,"['untrained volunteers', 'Fourteen subjects (26.2 ± 5 years old, 25.8 ± 3 kg·m']","['Vitamins C and E associated with cryotherapy', 'resistance exercise (RE) session', 'cryotherapy associated with vitamins (C and E', 'Cryotherapy', 'vitamins C (1 g) and E (800 UI) supplementation 40 minutes before exercise, with cryotherapy (immersion in water 15° C for 10 minutes), and the association (vitamins and cryotherapy']","['C-reactive protein', 'LPO', 'de Brito, E, Teixeira, AdO, Righi, NC, Paulitcth, FdS, da Silva, AMV, and Signori, LU', 'Muscle pain', 'Antioxidant capacity against radical peroxyl', 'CK', 'Inflammatory Response', 'Hemogram, inflammatory markers (C-reactive protein and creatine kinase [CK]), and parameters of oxidative stress (lipid peroxidation [LPO] and antioxidant capacity against radical peroxyl', 'pain']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0722563', 'cui_str': 'Peroxyl'}, {'cui': 'C0200631', 'cui_str': 'Complete blood count without differential'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0858852,Antioxidant capacity against radical peroxyl increased (30 minutes) only in recovery with the association (p < 0.011).,"[{'ForeName': 'Edineia', 'Initials': 'E', 'LastName': 'de Brito', 'Affiliation': 'Postgraduate Program in Functional Rehabilitation, Department of Physical Therapy and Rehabilitation, Federal University of Santa Maria-UFSM, Santa Maria, RS, Brazil.'}, {'ForeName': 'André de Oliveira', 'Initials': 'AO', 'LastName': 'Teixeira', 'Affiliation': 'Health Sciences Graduate Program, School of Medicine, Federal University of Rio Grande-FURG, Rio Grande, RS, Brazil.'}, {'ForeName': 'Natiele Camponogara', 'Initials': 'NC', 'LastName': 'Righi', 'Affiliation': 'Postgraduate Program in Functional Rehabilitation, Department of Physical Therapy and Rehabilitation, Federal University of Santa Maria-UFSM, Santa Maria, RS, Brazil.'}, {'ForeName': 'Felipe da Silva', 'Initials': 'FDS', 'LastName': 'Paulitcth', 'Affiliation': 'Health Sciences Graduate Program, School of Medicine, Federal University of Rio Grande-FURG, Rio Grande, RS, Brazil.'}, {'ForeName': 'Antonio Marcos Vargas', 'Initials': 'AMV', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Functional Rehabilitation, Department of Physical Therapy and Rehabilitation, Federal University of Santa Maria-UFSM, Santa Maria, RS, Brazil.'}, {'ForeName': 'Luis Ulisses', 'Initials': 'LU', 'LastName': 'Signori', 'Affiliation': 'Postgraduate Program in Functional Rehabilitation, Department of Physical Therapy and Rehabilitation, Federal University of Santa Maria-UFSM, Santa Maria, RS, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003342']
2601,33021598,"Evaluation of Dried Amniotic Membrane on Wound Healing at Split-Thickness Skin Graft Donor Sites: A Randomized, Placebo-Controlled, Double-blind Trial.","OBJECTIVE


To evaluate the effect of amniotic membrane (AM) at split-thickness skin graft (STSG) donor sites.
METHODS


This double-blind randomized controlled trial was conducted on 35 eligible participants referred to the burn unit of Vasei Hospital of Sabzevar, Iran, during 2017 and 2018. Each STSG donor site was divided into two sides, and the respective halves were covered with either a dried AM or petrolatum gauze (control). Outcomes were evaluated on postprocedure days 10, 20, and 30 using the Vancouver Scar Scale.
RESULTS


The mean age of the patients was 39.4 ± 13.97 years, and 62.8% (n = 22) were male. There was no statistically significant difference in wound healing rate on day 10 (P = .261), 20 (P = .214), or 30 (P = .187) between groups. The intervention group had significantly better epithelialization than the control group on day 10 (investigator 1, 1.62 ± 0.59 vs 1.40 ± 0.88 [P = .009); investigator 2, 1.22 ± 0.84 vs 0.91 ± 0.85 [P = .003]), as well as pain reduction (P < .001 during the follow-up period). However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
CONCLUSIONS


Findings suggest that the use of AM is not superior to petrolatum gauze in terms of STSG healing rate; however, AM achieved better pain reduction and epithelialization on day 10.",2020,"However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
","['The mean age of the patients was 39.4 ± 13.97 years, and 62.8% (n = 22) were male', '35 eligible participants referred to the burn unit of Vasei Hospital of Sabzevar, Iran, during 2017 and 2018']","['amniotic membrane (AM) at split-thickness skin graft (STSG', 'dried AM or petrolatum gauze (control', 'Dried Amniotic Membrane', 'Placebo']","['pain reduction and epithelialization', 'epithelialization', 'wound healing rate', 'Wound Healing at Split-Thickness Skin', 'pigmentation or vascularization', 'pain reduction', 'Vancouver Scar Scale']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0006425', 'cui_str': 'Burns unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",35.0,0.15686,"However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaheb', 'Affiliation': 'At the Sabzevar University of Medical Sciences in Iran, Mojtaba Vaheb, MD, is Plastic Surgery Specialist, Department of Dermatology; Bahareh Mohajer Kohestani, MD, is General Practitioner, Student Research Committee; Maryam Karrabi, MD, is Dermatologist, Department of Dermatology; Maryam Khosrojerdi, MSc, RN, is a nurse, Department of Nursing; Mahtab Khajeh, MD, is General Surgeon, Department of Surgery and Orthopedics; Ehsan Shahrestanaki, MSc, is Epidemiologist, Department of Biostatistics and Epidemiology; and Mohammad Sahebkar, MSc, is Epidemiologist, Department of Social Medicine. The authors have disclosed no financial relationships related to this article. Submitted February 9, 2020; accepted in revised form April 7, 2020.'}, {'ForeName': 'Bahareh Mohajer', 'Initials': 'BM', 'LastName': 'Kohestani', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khosrojerdi', 'Affiliation': ''}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': ''}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000695752.52235.e3']
2602,33021606,Add-on effect of clarithromycin to oral steroids as post- operative therapy for chronic rhinosinusitis with nasal polyps: a randomised controlled trial.,"BACKGROUND


Evidence is lacking regarding the efficacy of macrolides and oral corticosteroids in chronic rhinosinusitis with nasal polyps (CRSwNP) after endoscopic sinus surgery (ESS). Therefore, we examined the benefits of adding clarithromycin to oral pred- nisolone as post-ESS medical therapy in patients with CRSwNP.
METHODS


In this randomised, double-blind, placebo-controlled trial, patients were enrolled and allocated to three study groups receiving different post-ESS medical therapies: group A (placebo for 14 weeks), group B (oral prednisolone [15 mg twice daily] for 2 weeks, followed by placebo for 12 weeks), and group C (oral prednisolone [15 mg twice daily] for 2 weeks, followed by clari- thromycin [500 mg daily] for 12 weeks). All enrolled patients received the perioperative care following a routine protocol, which included oral amoxicillin/clavulanate, and intranasal corticosteroid spray. The baseline and post-operative visual analogue scale (VAS) scores, Sino-nasal Outcome Test (SNOT-22) scores, and Lund-Kennedy endoscopy scores (LKES) were determined as the primary outcomes.
RESULTS


One hundred twenty-six patients who received ESS for bilateral CRSwNP were randomised into group A (n=43), B (n=42), or C (n=41). Compared to groups A and B, group C showed greater VAS and SNOT-22 score improvement at 12 weeks after ESS. Group C showed significantly better LKES than did groups A and B at 8, 12, and 24 weeks after ESS. On stratifying the LKES results according to the presence/absence of tissue eosinophilia, greater add-on effects of clarithromycin were observed in the patient subgroup without tissue eosinophilia.
CONCLUSIONS


Adding low-dose clarithromycin to oral corticosteroids as post-ESS therapy was well tolerated and showed benefi- cial subjective and objective outcomes in patients with CRSwNP, especially those without tissue eosinophilia.",2020,"Group C showed significantly better LKES than did groups A and B at 8, 12, and 24 weeks after ESS.","['patients with CRSwNP', 'chronic rhinosinusitis with nasal polyps', 'One hundred twenty-six patients who received ESS for bilateral CRSwNP', 'chronic rhinosinusitis with nasal polyps (CRSwNP) after endoscopic sinus surgery (ESS']","['clarithromycin', 'prednisolone [15 mg twice daily] for 2 weeks, followed by clari- thromycin', 'LKES', 'placebo', 'post-ESS medical therapies: group A (placebo', 'amoxicillin/clavulanate, and intranasal corticosteroid spray', 'oral corticosteroids', 'prednisolone']","['baseline and post-operative visual analogue scale (VAS) scores, Sino-nasal Outcome Test (SNOT-22) scores, and Lund-Kennedy endoscopy scores (LKES', 'VAS and SNOT-22 score improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",126.0,0.189854,"Group C showed significantly better LKES than did groups A and B at 8, 12, and 24 weeks after ESS.","[{'ForeName': 'C-F', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'M-C', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Merton', 'Affiliation': 'Department of Otolaryngology, Vicente Sotto Memorial Medical Centre, Cebu, Philippines.'}, {'ForeName': 'N-H', 'Initials': 'NH', 'LastName': 'Ho', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'P-S', 'Initials': 'PS', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'A T-W', 'Initials': 'AT', 'LastName': 'Hsu', 'Affiliation': 'Department of Biostatistics and Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Y-P', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.'}]",Rhinology,['10.4193/Rhin19.325']
2603,33021649,Association of Peer Comparison Emails With Electronic Health Record Documentation of Cancer Stage by Oncologists.,"Importance


Systematically capturing cancer stage is essential for any serious effort by health systems to monitor outcomes and quality of care in oncology. However, oncologists do not routinely record cancer stage in machine-readable structured fields in electronic health records (EHRs).
Objective


To evaluate whether a peer comparison email intervention that communicates an oncologist's performance on documenting cancer stage relative to that of peer physicians was associated with increased likelihood that stage was documented in the EHR.
Design, Setting, and Participants


This 12-month, randomized quality improvement pilot study aimed to increase oncologist staging documentation in the EHR. The pilot study was performed at Massachusetts General Hospital Cancer Center from October 1, 2018, to September 30, 2019. Participants included 56 oncologists across 3 practice sites who treated patients in the ambulatory setting and focused on diseases that use standardized staging systems. Data were analyzed from July 2, 2019, to March 5, 2020.
Interventions


Peer comparison intervention with as many as 3 emails to oncologists during 6 months that displayed the oncologist's staging documentation rate relative to all oncologists in the study sample.
Main Outcomes and Measures


The primary outcome was patient-level documentation of cancer stage, defined as the likelihood that a patient's stage of disease was documented in the EHR after the patient's first (eg, index) ambulatory visit during the pilot period.
Results


Among the 56 oncologists participating (32 men [57%]), receipt of emails with peer comparison data was associated with increased likelihood of documentation of cancer stage using the structured field in the EHR (23.2% vs 13.0% of patient index visits). In adjusted analyses, this difference represented an increase of 9.0 (95% CI, 4.4-13.5) percentage points (P = .002) in the probability that a patient's cancer stage was documented, a relative increase of 69% compared with oncologists who did not receive peer comparison emails. The association increased with each email that was sent, ranging from a nonsignificant 4.0 (95% CI, -0.8 to 8.8) percentage points (P = .09) after the first email to a statistically significant 11.2 (95% CI, 4.9-17.4) percentage points (P = .003) after the third email . The association was concentrated among an oncologist's new patients (increase of 11.8 [95% CI, 6.2-17.4] percentage points; P = .001) compared with established patients (increase of 1.6 [95% CI, -2.9 to 6.1] percentage points; P = .44) and persisted for 7 months after the email communications stopped.
Conclusions and Relevance


In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.",2020,"In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.","['Massachusetts General Hospital Cancer Center from October 1, 2018, to September 30, 2019', '56 oncologists participating (32 men [57', 'Participants included 56 oncologists across 3 practice sites who treated patients in the ambulatory setting and focused on diseases that use standardized staging systems']",['peer comparison email intervention'],"['likelihood of documentation of cancer stage', ""patient-level documentation of cancer stage, defined as the likelihood that a patient's stage of disease""]","[{'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}]","[{'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.108324,"In a quality improvement pilot trial, peer comparison emails were associated with a substantial increase in oncologist use of the structured field in the EHR to document stage of disease.","[{'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Sinaiko', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Barnett', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Marema', 'Initials': 'M', 'LastName': 'Gaye', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Soriano', 'Affiliation': 'Patient Care Services, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Mulvey', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ephraim', 'Initials': 'E', 'LastName': 'Hochberg', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, General Hospital Cancer Center and Harvard Medical School, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15935']
2604,33021670,Increasing Life-Space Mobility in community-dwelling older persons with cognitive impairment following rehabilitation: A randomized controlled trial.,"BACKGROUND


Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk for losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The study aim was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM.
METHODS


Older persons with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group (IG) received a CI-specific, home-based strength, balance and walking training supported by tailored motivational strategies. The control group (CG) received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment (LSA-CI), including a composite score for LSM and three sub-scores for maximal, equipment-assisted and independent life-space. Mixed-model repeated-measures analyses were used.
RESULTS


One hundred eighteen participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the LSA-CI composite scores (b=8.15; 95% confidence interval: 2.89-13.41; p=.003) and independent life-space sub-scores (b= 0.39; 95% confidence interval: 0.00-0.78; p=.048) in the IG (n=63) compared to CG (n=55). Other sub-scores and follow-up results were not significantly different.
CONCLUSIONS


The home-based training program improved LSM and independent life-space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.",2020,"After the intervention, the home-based training program resulted in a significant benefit in the LSA-CI composite scores (b=8.15; 95% confidence interval: 2.89-13.41; p=.003) and independent life-space sub-scores (b= 0.39;","['community-dwelling older persons with cognitive impairment following rehabilitation', 'One hundred eighteen participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) were randomized', 'Community-dwelling older persons with cognitive impairment (CI', 'Older persons with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home from rehabilitation', 'Persons with Cognitive Impairment (LSA-CI']","['CI-specific, home-based strength, balance and walking training supported by tailored motivational strategies', 'CI-specific, home-based physical training and activity promotion program', 'placebo activity', 'placebo', 'LSM']","['life-space sub-scores', 'LSA-CI composite scores']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",118.0,0.12261,"After the intervention, the home-based training program resulted in a significant benefit in the LSA-CI composite scores (b=8.15; 95% confidence interval: 2.89-13.41; p=.003) and independent life-space sub-scores (b= 0.39;","[{'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Ullrich', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bongartz', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Abel', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Schönstein', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg/Geriatric Center at the Heidelberg University, Heidelberg, Germany.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa254']
2605,33021688,Near-focus magnification and second-generation narrow-band imaging for early gastric cancer in a randomized trial.,"BACKGROUND


Magnifying endoscopy with narrow-band imaging (NBI) is effective for the diagnosis of early gastric cancer (EGC). However, magnifying endoscopy is not yet popular globally because of the required level of skill and lack of availability. To overcome these problems, dual-focus endoscopy (standard- and near-focus (NF) modes) has been developed. In this study, we evaluated the diagnostic performance of NF with second-generation (2G)-NBI (NF-NBI) for the diagnosis of EGC.
METHODS


This was a secondary analysis of a multicenter randomized controlled trial of 4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan. Patients were randomly assigned to white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI. Lesions suspicious for EGC, newly detected by non-magnifying WLI or 2G-NBI, were subsequently observed with NF-NBI. All detected lesions were biopsied or resected. The diagnostic performance of NF-NBI was compared with the final histology.
RESULTS


A total of 870 detected lesions (145 EGC, 725 non-EGC) were analyzed. Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%. There were no significant differences in diagnostic performance between lesions detected by WLI or 2G-NBI. For lesions diagnosed with high (333 lesions) and low (537 lesions) confidences, accuracy was 92.2% and 84.9%, sensitivity was 64.7% and 58.5%, and specificity was 90.5% and 88.8%, respectively.
CONCLUSION


The diagnostic performance of NF-NBI is good and acceptable for diagnosis of EGC in combination with either WLI or 2G-NBI.",2020,"Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%.","['A total of 870 detected lesions (145 EGC, 725 non-EGC', '4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan']","['Near-focus magnification and second-generation narrow-band imaging', 'white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI', 'Magnifying endoscopy with narrow-band imaging (NBI', 'NF with second-generation (2G)-NBI (NF-NBI']","['Overall diagnostic performance', 'sensitivity', 'diagnostic performance of NF-NBI', 'diagnostic performance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}]",4523.0,0.160259,"Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakushima', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Shizuoka, Suntougun, 411-8777, Japan. n.kakushima@gmail.com.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Doyama', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Horimatsu', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Noriya', 'Initials': 'N', 'LastName': 'Uedo', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Endoscopy, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oda', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Department of Advanced Medicine Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Chizu', 'Initials': 'C', 'LastName': 'Yokoi', 'Affiliation': 'Endoscopy Division, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Biostatistics, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Muto', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-020-01734-3']
2606,33021715,Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.,"BACKGROUND


Strict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow.
OBJECTIVE


To evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients.
DESIGN


Randomized community intervention trial.
PARTICIPANTS


The control group comprised 967 patients who received standard antihypertensive drug intervention therapy from two communities, whereas the intervention group comprised 1945 patients who received antihypertensive drug and lifestyle intervention therapies from four communities in rural China.
MAIN MEASURES


Data on lifestyle behaviors and BP measurements at baseline and 1-year follow-up were collected. A difference-in-difference logistic regression model was used to assess the effect of the intervention.
KEY RESULTS


BP control after the 1-year intervention was better than that at baseline in both groups. The within-group change in BP control of 59.3% in the intervention group was much higher than the 25.2% change in the control group (P < 0.001). Along with the duration of the follow-up period, systolic and diastolic BP decreased rapidly in the early stages and then gradually after 6 months in the intervention group (P < 0.001). In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1 month to 87.6% at 1 year) (P < 0.001), more in women (45.6%) than in men (31.2%; P < 0.001). The net effect of the lifestyle intervention improved the rate of BP control by 56.1% (70.8% for men and 44.7% for women). For all physiological and biochemical factors, such as body mass index, waist circumference, lipid metabolism, and glucose control, improvements were more significant in the behavioral intervention group than those in the control group (all P < 0.001).
CONCLUSION


The addition of lifestyle intervention by physicians or nurses helps control BP effectively and lowers BP better than usual care with antihypertensive drug therapy alone.",2020,"In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1 month to 87.6% at 1 year)","['Rural China', 'Hypertensive Patients', 'rural hypertensive patients', '1945 patients who received', 'from four communities in rural China', '967 patients who received', 'hypertensive patients']","['Lifestyle and Drug Intervention', 'standard antihypertensive drug intervention therapy', 'lifestyle intervention', 'antihypertensive drug and lifestyle intervention therapies', 'lifestyle and drug intervention']","['systolic and diastolic BP', 'BP control', 'blood pressure (BP', 'drug therapy adherence', 'rate of BP control', 'lifestyle behaviors and BP measurements']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",,0.0558827,"In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1 month to 87.6% at 1 year)","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Wen-Long', 'Initials': 'WL', 'LastName': 'Ren', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Liang', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yue-Xia', 'Initials': 'YX', 'LastName': 'Gao', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Chu', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xiao-Jian', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': ""Department of Chronic Disease and Prevention, Center for Disease Control and Prevention of Haian, Nantong, People's Republic of China.""}, {'ForeName': 'Zuo-Feng', 'Initials': 'ZF', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': ""Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, Jiangsu, People's Republic of China. ntzhuang@163.com.""}, {'ForeName': 'Yong-Fu', 'Initials': 'YF', 'LastName': 'Yu', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05601-7']
2607,32981192,Dietary intake on days with and without hypoglycemia in youth with type 1 diabetes: The Flexible Lifestyle Empowering Change trial.,"OBJECTIVE


To address a common perception that hypoglycemia is associated with increased dietary intake, we examined calorie and carbohydrate consumption on days with and without hypoglycemia among adolescents with type 1 diabetes (T1D).
METHODS


Days (N = 274) with 24-hour dietary recalls and continuous glucose monitoring were available for 122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16 years, diabetes duration >1 year, hemoglobin A1c 8%-13%). Days with no hypoglycemia, clinical hypoglycemia (54-69 mg/dL) or clinically serious hypoglycemia (<54 mg/dL) were further split into night (12-5:59 am) and day (6 am-11:59 pm). Mixed models tested whether intake of calories or carbohydrates was greater on days with than without hypoglycemia.
RESULTS


Fifty-nine percent, 23% and 18% of days had no hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia, respectively. Intake of calories and carbohydrates was not statistically significantly different on days with clinical hypoglycemia (57.2 kcal [95% CI -126.7, 241.5]; 12.6 g carbohydrate [95% CI -12.7, 38.0]) or clinically serious hypoglycemia (-74.0 kcal [95% CI -285.9, 137.9]; (-7.8 g carbohydrate [95% CI -36.8, 21.1]), compared to days without hypoglycemia. Differences by day and night were not statistically significant.
CONCLUSIONS


Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia. It is possible that hypoglycemic episodes caused by undereating relative to insulin dosing, followed by overeating, leading to a net neutral difference. Given the post-hoc nature of these analyses, larger studies should be designed to prospectively test the hypoglycemia-diet relationship.",2020,"Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia.","['adolescents with type 1 diabetes (T1D', 'Days (N = 274) with', 'youth with type 1 diabetes', '122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13-16\u2009years, diabetes duration >1\u2009year, hemoglobin A1c 8%-13']",['24-hour dietary recalls and continuous glucose monitoring'],"['hypoglycemia, clinical hypoglycemia', 'hypoglycemia, clinical hypoglycemia and clinically serious hypoglycemia', 'clinically serious hypoglycemia', 'clinical hypoglycemia', 'Intake of calories and carbohydrates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",274.0,0.0374345,"Among adolescents with T1D, daily intake of calories and carbohydrates did not differ on days with and without hypoglycemia.","[{'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Igudesman', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Crandell', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Zhong', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, 14853, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Cristello Sarteau', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Kahkoska', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Corbin', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, 32804, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, 32804, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'Department of Pediatrics, Division of Endocrinology, Stanford University, Stanford, California, 94305, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Mayer-Davis', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, USA.'}]",Pediatric diabetes,['10.1111/pedi.13132']
2608,31647257,"Beyond the ""self"" in self-regulation: Family interaction modulates situational self-control by adolescent drug users.","Prevailing views of adolescent self-regulation (ASR) as a relatively stable disposition or skill that an individual possesses in various degrees stand in contrast to a complementary, situational perspective from family systems theory casting ASR as intertwined with ongoing family processes and malleable depending on interpersonal interactions. Using observational data from a large, ethnically diverse sample of substance-using adolescents ( N  = 458), the current study examines the social context of ASR across 3 increasingly conflictual family interaction tasks. Coders rated ASR and 3 concurrent family interaction patterns: enmeshment, conflict avoidance, and negative affect. ASR declined across the 3 tasks, and independent of this systematic change, family-level negative affect in the first task exerted a strong lagged statistical effect on subsequent declines in ASR. The findings are consistent with family systems theory in both the context-dependent nature of ASR behavior and the modulating role of family interaction. In addition to its well-established dispositional properties, ASR may be of interest as a context-specific and potentially modifiable dependent variable. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"ASR declined across the 3 tasks, and independent of this systematic change, family-level negative affect in the first task exerted a strong lagged statistical effect on subsequent declines in ASR.",['ethnically diverse sample of substance-using adolescents ( N  = 458'],['adolescent self-regulation (ASR'],['ASR'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5191377', 'cui_str': '458'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0191541,"ASR declined across the 3 tasks, and independent of this systematic change, family-level negative affect in the first task exerted a strong lagged statistical effect on subsequent declines in ASR.","[{'ForeName': 'Bonita', 'Initials': 'B', 'LastName': 'Sur', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Cleary', 'Affiliation': 'Division of Student Affairs.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rohrbaugh', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ferrer', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Sbarra', 'Affiliation': 'Department of Psychology.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000598']
2609,31922424,Understanding the adverse event experience in the S-TRAC adjuvant trial of sunitinib for high-risk renal cell carcinoma.,"Until recently, the sole treatment for patients with nonmetastatic renal cell carcinoma (RCC) was nephrectomy followed by observation. As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed. In November 2017, sunitinib was approved in the USA as the first adjuvant therapy for patients at high risk for recurrent RCC postnephrectomy based on results from the S-TRAC trial. Patients eligible for adjuvant treatment have no evidence of disease and may be less willing to tolerate side effects. Therefore, proactive adverse event management is critical for keeping patients on adjuvant treatment and requires understanding the subtle differences in the adverse event profile of sunitinib in the adjuvant versus metastatic RCC setting.",2020,"As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed.","['patients with nonmetastatic renal cell carcinoma (RCC', 'high-risk renal cell carcinoma', 'patients at high risk for recurrent RCC postnephrectomy based on results from the S-TRAC trial']",['sunitinib'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278679', 'cui_str': 'Renal cell carcinoma recurrent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0429597,"As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed.","[{'ForeName': 'Sarah Yenser', 'Initials': 'SY', 'LastName': 'Wood', 'Affiliation': 'Duke University Medical Center, Division of Oncology, 20 Duke Medicine Circle, Durham, NC 27710-4000, USA.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Ryan', 'Affiliation': 'Pfizer Oncology, 235 E 42nd St, New York, NY 10017, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Clair', 'Affiliation': 'Pfizer Oncology, 235 E 42nd St, New York, NY 10017, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke University Medical Center, Division of Oncology, 20 Duke Medicine Circle, Durham, NC 27710-4000, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0369']
2610,31973936,Economic Evaluation of Adding Daratumumab to a Regimen of Bortezomib + Dexamethasone in Relapsed or Refractory Multiple Myeloma: Based on the Latest Updated Analysis of CASTOR.,"PURPOSE


Adding daratumumab to a regimen of bortezomib + dexamethasone (Vd) has been reported to provide a benefit of longer progression-free survival in patients with relapsed or refractory multiple myeloma (RRMM). However, it is still unclear whether the addition of daratumumab is cost-effective in RRMM. Based on the latest updated analysis of data from the CASTOR trial, this study performed an economic evaluation of the addition of daratumumab to Vd in patients with RRMM.
METHODS


A Markov decision model was used for estimating the long-term costs and efficacy of Vd with or without daratumumab in patients with RRMM. Data on efficacy were taken from the CASTOR trial to compare Vd + daratumumab with Vd. Costs were taken from the US Centers for Medicare & Medicaid Services and from the literature. A series of sensitivity analyses were performed to address the robustness of the model. Variations in the price of daratumumab and subgroup analyses were conducted.
FINDINGS


The base-case analysis showed that adding daratumumab to Vd provided an additional 1.256 quality-adjusted life-years (QALYs) or 1.645 life-years (LYs), with incremental 213,164 USD (163,184 USD) per QALY (LY) gained. Univariate sensitivity analyses suggested that the subsequent treatment cost of DVd and the price of daratumumab had the greatest effect on the incremental cost-effectiveness ratio. According to the variations analysis of the price of daratumumab, the addition of daratumumab would be cost-effective when daratumumab was priced at 70% (30%) of the current price at a willingness-to-pay threshold of 200,000 USD/QALY (150,000 USD/QALY). Subgroup analysis indicated that adding daratumumab to Vd was most cost-effective in patients with 1 prior line of therapy.
IMPLICATIONS


From a US-payer perspective, daratumumab added to Vd in RRMM is likely to exceed the common accepted values of cost-effectiveness.",2020,"The base-case analysis showed that adding daratumumab to Vd provided an additional 1.256 quality-adjusted life-years (QALYs) or 1.645 life-years (LYs), with incremental 213,164 USD (163,184 USD) per QALY (LY) gained.","['patients with RRMM', 'patients with relapsed or refractory multiple myeloma (RRMM', 'Relapsed or Refractory Multiple Myeloma']","['Bortezomib\xa0+ Dexamethasone', 'bortezomib\xa0+\xa0dexamethasone (Vd']",['incremental cost-effectiveness ratio'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0291773,"The base-case analysis showed that adding daratumumab to Vd provided an additional 1.256 quality-adjusted life-years (QALYs) or 1.645 life-years (LYs), with incremental 213,164 USD (163,184 USD) per QALY (LY) gained.","[{'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'PET-CT Center, The Second Xiangya Hospital, Central South University, Hunan, China.'}, {'ForeName': 'Liubao', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Hunan, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Hunan, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Hunan, China. Electronic address: tanchongqing@csu.edu.cn.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Pharmacy, The Second Xiangya Hospital, Central South University, Hunan, China.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.12.007']
2611,32209931,Change in Incisional Design in Primary Unilateral Cleft Lip Repair Under General Anesthesia.,"Nasolabial features of infants with unilateral cleft lip (UCL) are different when they are under general anesthesia for lip repair compared to when they are awake. This study aimed to investigate changes in the incisional design of cheiloplasty according to patient position and anesthesia: upright and awake versus supine and under general anesthesia. Three-dimensional images of 20 infants with UCL were randomly selected. Two different incisional designs were drawn on the images captured while the infants were awake. Those incisional designs were anthropometrically compared to the designs drawn on the images captured while the infants were under general anesthesia. Under general anesthesia, vermillion height of both the medial and lateral sides of the cleft became significantly greater. In the rotation-advancement design, the incisional line of the rotation flap on the medial lip element became significantly shorter under general anesthesia, whereas the advancement flap on the lateral lip element was not significantly altered. In an anatomical subunit approximation, both lengths of the philtral ridge on the noncleft side and incisional line along the philtral ridge on the cleft side became significantly shorter under general anesthesia, but these alterations did not affect the calculation of the width of the small triangular flap on the lateral lip element. These changes in nasolabial features after general anesthesia may cause surgical error, which result in secondary cleft lip deformities. However, because these changes varied among infants, preoperative planning using three-dimensional facial images of infants who are awake may be able to avoid surgical error.",2020,"These changes in nasolabial features after general anesthesia may cause surgical error, which result in secondary cleft lip deformities.","['20 infants with UCL', 'infants with unilateral cleft lip (UCL', 'Primary Unilateral Cleft Lip Repair Under General Anesthesia']",['anesthesia: upright and awake versus supine and under general anesthesia'],"['lateral lip element', 'nasolabial features']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0008924', 'cui_str': 'Cleft lip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0192070', 'cui_str': 'Repair of cleft lip'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",20.0,0.041194,"These changes in nasolabial features after general anesthesia may cause surgical error, which result in secondary cleft lip deformities.","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Morioka', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}, {'ForeName': 'Yasuyoshi', 'Initials': 'Y', 'LastName': 'Tosa', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kadomatsu', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Showa University Fujigaoka Hospital, Kanagawa.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006399']
2612,32302705,Comparison between Antimicrobial Photodynamic Therapy and Low-level laser therapy on non-surgical periodontal treatment: A Clinical Study.,"BACKGROUND


Alternative antibacterial therapeutic modalities, such as antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT), have been proposed to improve the effectiveness of periodontal treatment. However, clinical studies evaluating the efficiency of these treatments have been inconclusive, partly due to contradictory results regarding their clinical and microbiological effects. The aim of this study was to evaluate the clinical effects of aPDT and LLLT after a one-stage full-mouth disinfection (OSFMD) protocol during periodontitis treatment.
METHODS


A split-mouth clinical trial was conducted in 20 patients presenting at least two contralateral teeth with a probing pocket depth (PD) ≥ 5 mm and bleeding on probing (BOP) on both sides of the mouth. All patients were submitted to an OSFMD protocol. The selected sites randomly received either (1) aPDT (methylene blue as a photosensitizer activated by red and infrared diode laser) or (2) LLLT (red and infrared diode laser). Clinical parameters were assessed at baseline and at 4 and 12 weeks post-treatment.
RESULTS


Both treatment protocols promoted significant reductions in PD, number of deep pockets and BOP and an increase in clinical attachment level (CAL) after 4 and 12 weeks, but there were no differences between the two groups. There was no change in the gingival level (GL) of either group for all periods of analysis. A decrease in the number of moderate pockets (4-5 mm) was found in the LLLT group (5.15 ± 4.20) when compared to the aPDT group (7.10 ± 5.24), but only after 4 weeks.
CONCLUSIONS


In conclusion, both the aPDT and LLLT therapies promoted improvements in periodontal clinical parameters after the OSFMD protocol; however, in general, there were no distinct differences between the two treatment modalities evaluated in this study.",2020,"Both treatment protocols promoted significant reductions in PD, number of deep pockets and BOP and an increase in clinical attachment level (CAL) after 4 and 12 weeks, but there were no differences between the two groups.","['non-surgical periodontal treatment', '20 patients presenting at least two contralateral teeth with a probing pocket depth (PD) ≥\u202f5\u202fmm and bleeding on probing (BOP) on both sides of the mouth']","['antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT', 'LLLT', 'aPDT and LLLT', 'Antimicrobial Photodynamic Therapy and Low-level laser therapy', 'aPDT (methylene blue as a photosensitizer activated by red and infrared diode laser) or (2) LLLT (red and infrared diode laser']","['number of moderate pockets', 'clinical attachment level (CAL', 'gingival level (GL', 'periodontal clinical parameters', 'PD, number of deep pockets and BOP']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]",20.0,0.049573,"Both treatment protocols promoted significant reductions in PD, number of deep pockets and BOP and an increase in clinical attachment level (CAL) after 4 and 12 weeks, but there were no differences between the two groups.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Engel Naves Freire', 'Affiliation': 'Department of Clinics and Surgery, School of Dentistry, Alfenas Federal University, Gabriel Monteiro St, 700, Center, 37130-001, Alfenas, MG, Brazil.'}, {'ForeName': 'Thaisa', 'Initials': 'T', 'LastName': 'Macedo Iunes Carrera', 'Affiliation': 'Department of Clinics and Surgery, School of Dentistry, Alfenas Federal University, Gabriel Monteiro St, 700, Center, 37130-001, Alfenas, MG, Brazil.'}, {'ForeName': 'Guilherme José Pimentel Lopes', 'Initials': 'GJPL', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Periodontology, School of Dentistry, Uberlandia Federal University (UFU), Uberlandia, Minas Gerais, Brazil.'}, {'ForeName': 'Suzane Cristina', 'Initials': 'SC', 'LastName': 'Pigossi', 'Affiliation': 'Department of Clinics and Surgery, School of Dentistry, Alfenas Federal University, Gabriel Monteiro St, 700, Center, 37130-001, Alfenas, MG, Brazil. Electronic address: supigossi@ymail.com.'}, {'ForeName': 'Noé', 'Initials': 'N', 'LastName': 'Vital Ribeiro Júnior', 'Affiliation': 'Department of Clinics and Surgery, School of Dentistry, Alfenas Federal University, Gabriel Monteiro St, 700, Center, 37130-001, Alfenas, MG, Brazil.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101756']
2613,33009572,A novel phage display vector for selection of target-specific peptides.,"Intrinsic low display level of polypeptides on phage is a fundamental and limiting hurdle in successful isolation of target-specific binders by phage display technology. To circumvent this challenge, we optimized the copy number of peptides displayed on the phage surface using type 33 phage vector. We randomized the first 67 amino acids of the wild type PIII to identify mutants that would result in its reduced expression. Consequently, the display level was improved by 30-fold due to higher incorporation of the synthetic PIII-peptide fusion protein on the phage surface. Utilization of this novel phage vector should provide a solid basis for the discovery of therapeutic peptides.",2020,"Consequently, the display level was improved by 30-fold due to higher incorporation of the synthetic PIII-peptide fusion protein on the phage surface.",[],[],[],[],[],[],,0.0185675,"Consequently, the display level was improved by 30-fold due to higher incorporation of the synthetic PIII-peptide fusion protein on the phage surface.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Department of Pharmacy, Santa Clara Valley Medical Center, San Jose CA 95128, USA.'}, {'ForeName': 'Joey P', 'Initials': 'JP', 'LastName': 'Ting', 'Affiliation': 'Protein Engineering, Eli Lilly Biotechnology Center, San Diego, CA 92121, USA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Espada', 'Affiliation': 'Department of Discovery Chemistry Research & Technology, Centro de Investigacion Lilly, Av. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Broughton', 'Affiliation': 'Department of Discovery Chemistry Research & Technology, Centro de Investigacion Lilly, Av. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Molina-Martin', 'Affiliation': 'Department of Discovery Chemistry Research & Technology, Centro de Investigacion Lilly, Av. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Afshar', 'Affiliation': 'Protein Engineering, Eli Lilly Biotechnology Center, San Diego, CA 92121, USA.'}]","Protein engineering, design & selection : PEDS",['10.1093/protein/gzaa023']
2614,33009898,"Direct anterior versus posterior approach for total hip arthroplasty: a multicentre, prospective, randomized clinical trial.","BACKGROUND


The ideal approach for a total hip arthroplasty (THA) would be kind to soft tissues, have the lowest complication rates and be easily reproducible. Although there have been several attempts to find the best approach for THA in the last decade, a definitive answer has not been found. We performed a prospective study to compare the direct anterior and posterior approaches for THA in terms of hospital length of stay, functional outcome, pain, implant position, complications and surgical time.
METHODS


A prospective, randomized, multicentre clinical study was conducted between February 2011 and July 2013, with an average follow-up of 55 months. Patients undergoing the direct anterior or posterior approach for THA were enrolled. Hospital length of stay, surgical time and complications were documented. The Harris Hip Score and visual analogue scale were used to monitor functional outcome and pain until 5 years postoperatively. Radiologic analysis was used to assess implant position.
RESULTS


Fifty-five patients (28 undergoing the direct anterior approach, 27 undergoing the posterior approach) were enrolled in this study. Length of stay, functional outcome, pain, implant position and complications were similar for the 2 approaches. There was a trend toward a better functional outcome for patients who underwent the direct anterior approach in the first 3 months postoperatively, with a peak at 4 weeks (Harris Hip Score 76.7 v. 68.7;  p  = 0.08). Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min;  p  = 0.002).
CONCLUSION


The direct anterior approach for THA appears to be a safe and effective option. However, there is no significant difference in hospital length of stay or postoperative recovery between the 2 approaches.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov, no. NCT03673514.",2020,"Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min;  p  = 0.002).
","['Patients undergoing the direct anterior or posterior approach for THA were enrolled', 'Fifty-five patients (28 undergoing the direct anterior approach, 27 undergoing the posterior approach', 'February 2011 and July 2013, with an average follow-up of 55 months', 'total hip arthroplasty']",['Direct anterior versus posterior approach'],"['Hospital length of stay, surgical time and complications', 'Harris Hip Score and visual analogue scale', 'functional outcome', 'Average surgical time', 'hospital length of stay or postoperative recovery', 'hospital length of stay, functional outcome, pain, implant position, complications and surgical time', 'Length of stay, functional outcome, pain, implant position and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",27.0,0.0419216,"Average surgical time for the direct anterior approach was significantly longer (69.9 v. 45.7 min;  p  = 0.002).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moerenhout', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Derome', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'G Yves', 'Initials': 'GY', 'LastName': 'Laflamme', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leduc', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Henry S', 'Initials': 'HS', 'LastName': 'Gaspard', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'From the Department of Orthopaedics and Traumatology, Lausanne University Hospital, Lausanne, Switzerland (Moerenhout); Division of Orthopedic Surgery, Department of Surgery, Hôpital Sacré-Coeur de Montréal, Montreal, Que. (Moerenhout, Derome, Laflamme, Leduc, Benoit); and Department of Orthopedic Surgery, Hull Hospital, Gatineau, Que. (Gaspard).'}]",Canadian journal of surgery. Journal canadien de chirurgie,[]
2615,33010240,"Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial.","BACKGROUND


ADVANCE compared the efficacy and safety of two antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide), with a third regimen (efavirenz combined with emtricitabine and tenofovir disoproxil fumarate) previously recommended by WHO. Here, we report the 96-week data for the study.
METHODS


This randomised, open-label, non-inferiority phase 3 trial, was done at two research sites in Johannesburg, South Africa, after participant recruitment from 11 public health clinics also in Johannesburg. Eligible participants were aged 12 years or older with HIV-1 infection, who weighed at least 40 kg, had no antiretroviral exposure in the previous 6 months, with a creatinine clearance of more than 60 mL/min (>80 mL per min in individuals aged <19 years), and a plasma HIV-1 RNA concentration of 500 copies per mL or higher. Individuals who were pregnant or had tuberculosis were excluded. Participants were randomly assigned (1:1:1) by study staff using a computerised randomisation system. Randomisation was stratified by age (12 and <19 years and ≥19 years). Participants were randomly assigned to once-daily oral fixed-dose combination tenofovir alafenamide 25 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combination tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combination of tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, and efavirenz 600 mg. The primary efficacy endpoint was the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at week 48, which has been reported previously. Here, we report the key secondary efficacy endpoint of the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at the week 96 visit, assessed in all participants who received at least one dose of any study drug, with a prespecified non-inferiority margin of -10%. Safety data, including clinical, dual-energy X-ray absorptiometry and laboratory data, are also reported. This study was registered with ClinicalTrials.gov, NCT03122262.
FINDINGS


Between Jan 17, 2017, and May 14, 2018, we screened 1453 individuals, of whom 1053 were enrolled: 351 participants were randomly assigned to the tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group. All participants received at least one dose of study medication and were included in the primary analysis. At week 96, 276 (79%) of 351 participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group, 275 (78%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 258 (74%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group had achieved a plasma HIV-1 RNA concentration of less than 50 copies per mL. Non-inferiority was established in all three comparisons. The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups. Participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group had fewer changes in bone density than the two other treatment groups. Mean weight gain was substantial (7·1 kg [SD 7·4] in the tenofovir alafenamide, emtricitabine, and dolutegravir group; 4·3 kg [6·7] in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2·3 kg [7·0] in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group), and was greater among women than men. Ten (3%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group discontinued due to treatment-related adverse events, of which liver dysfunction (n=4) and rash (n=4) were most common.
INTERPRETATION


Medium-term and long-term metabolic and clinical consequences of the considerable increase in bodyweight observed in participants given these antiretroviral regimens and the trajectory of this weight gain over time, especially among women, require further study.
FUNDING


USAID, Unitaid, South African Medical Research Council, ViiV Healthcare.",2020,The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups.,"['Individuals who were pregnant or had tuberculosis were excluded', 'two research sites in Johannesburg, South Africa, after participant recruitment from 11 public health clinics also in Johannesburg', 'women than men', 'group, and 258 (74%) of 351 participants in the', 'Between Jan 17, 2017, and May 14, 2018, we screened 1453 individuals, of whom 1053 were enrolled: 351 participants', 'participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at the week 96 visit, assessed in all participants who received at least one dose of any study drug, with a prespecified non-inferiority margin of -10', 'Eligible participants were aged 12 years or older with HIV-1 infection, who weighed at least 40 kg, had no antiretroviral exposure in the previous 6 months, with a creatinine clearance of more than 60 mL/min (>80 mL per min in individuals aged <19 years']","['tenofovir alafenamide, emtricitabine, and dolutegravir', 'tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group', 'efavirenz combined with emtricitabine and tenofovir disoproxil fumarate', 'tenofovir disoproxil fumarate, emtricitabine, and dolutegravir', 'antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide', 'tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2·3 kg [7·0] in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz', 'tenofovir alafenamide, emtricitabine', 'tenofovir disoproxil fumarate, emtricitabine, and efavirenz', 'tenofovir alafenamide 25 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combination tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combination of tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, and efavirenz', 'emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate']","['plasma HIV-1 RNA concentration', 'efficacy and safety', 'bone density', 'virological failure', 'Mean weight gain', 'proportion of participants who had a plasma HIV-1 RNA concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1576947', 'cui_str': 'Tenofovir disoproxil fumarate 300 MG'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",351.0,0.359649,The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups.,"[{'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: fventer@ezintsha.org.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nkuli', 'Initials': 'N', 'LastName': 'Mashabane', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Celicia', 'Initials': 'C', 'LastName': 'Serenata', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Masebole', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Nomathemba', 'Initials': 'N', 'LastName': 'Chandiwana', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'McCann', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'South African Medical Research Council and Wits Developmental Pathways for Health Research Unit, Department of Pediatrics, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chersich', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Lalla-Edward', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alinda', 'Initials': 'A', 'LastName': 'Vos', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Clayden', 'Affiliation': 'HIV i-Base, London, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Arulappan', 'Affiliation': 'Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, Liverpool University, Liverpool, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30241-1']
2616,33010241,"Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon.","BACKGROUND


Updated WHO guidelines recommend a dolutegravir-based regimen as the preferred first-line treatment for HIV infection and low-dose efavirenz (400 mg) as an alternative. We aimed to report the non-inferior efficacy of dolutegravir compared with efavirenz 400 mg at week 96.
METHODS


We did a multicentre, randomised, open label, phase 3 trial in in three hospitals in Yaoundé, Cameroon, in HIV-1 infected antiretroviral-naive adults with an HIV RNA viral load of greater than 1000 copies per mL to compare dolutegravir 50 mg with efavirenz 400 mg (reference treatment), both combined with lamivudine and tenofovir disoproxil fumarate. The primary endpoint was the proportion with a viral load of less than 50 copies per mL at week 48 (10% non-inferiority margin). The study is registered with ClinicalTrials.gov, NCT02777229 and is ongoing.
FINDINGS


Between July, 2016, and August, 2019, of 820 patients assessed, 613 were randomly assigned to receive at least one dose of study medication, with 310 in the dolutegravir group and 303 in the efavirenz 400 mg group. At week 96 in the intention-to-treat analysis, 229 (74%) of 310 patients receiving dolutegravir and 219 (72%) of 303 patients receiving efavirenz, achieved plasma HIV-1 RNA less than 50 copies per mL (difference 1·6%, 95% CI -5·4 to 8·6; p=0.66). Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001). Virological failure (>1000 copies per mL) was observed in 27 patients (eight in the dolutegravir group, among which, three women switched to efavirenz 600 mg because of the dolutegravir teratogeneicity signal, and 19 in the efavirenz 400 mg group). No acquired resistance mutations to dolutegravir were observed against 17 mutations to efavirenz with or without mutations to lamivudine and tenofovir disoproxil fumarate among the 19 efavirenz 400 mg participants with virological failure. Weight gain was greater in the dolutegravir group (median weight gain, 5·0 kg in the dolutegravir group and 3·0 kg in the efavirenz 400 mg group, p<0·001, and incidence of obesity, 22% in the dolutegravir group and 16% in the efavirenz 400 mg group, p=0·043). The incidence of new WHO HIV-related stage 3 and 4 events was similar in each group (12 [4%] in each group). The two groups had similar rates of serious adverse events (28 [9%] of 310 in the dolutegravir group and 21 [7%] of 303 in the efavirenz 400 mg group). 18 deaths were observed during the 96-week follow-up (eight in the dolutegravir group and ten in the efavirenz 400 mg group).
INTERPRETATION


The non-inferior efficacy of the dolutegravir-based regimen and non-emergence of dolutegravir resistance at 96 weeks supports its use as a first-line regimen for antiretroviral-naive adults with HIV-1 infection. Viral load suppression was reached more quickly in the dolutegravir group and weight gain was significantly higher.
FUNDING


UNITAID and the French National Agency for AIDS Research.",2020,Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001).,"['HIV-1 infection (NAMSAL', '400 mg participants with virological failure', 'three hospitals in Yaoundé, Cameroon, in HIV-1 infected antiretroviral-naive adults with an HIV RNA viral load of greater than 1000 copies per mL to compare', 'antiretroviral-naive adults with HIV-1 infection', 'Between July, 2016, and August, 2019, of 820 patients assessed, 613 were randomly assigned to receive at least one dose of study medication, with 310 in the dolutegravir group and 303 in the']","['dolutegravir', 'dolutegravir 50 mg with efavirenz 400 mg (reference treatment), both combined with lamivudine and tenofovir disoproxil fumarate', 'efavirenz', 'Dolutegravir-based and low-dose efavirenz', 'dolutegravir-based regimen and non-emergence of dolutegravir resistance', 'lamivudine and tenofovir disoproxil fumarate']","['plasma HIV-1 RNA less', 'weight gain', 'Virological failure', 'Weight gain', 'incidence of new WHO HIV-related stage 3 and 4 events', 'Viral load suppression', 'rates of serious adverse events', 'proportion with a viral load']","[{'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C4555930', 'cui_str': 'efavirenz 400 MG'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3871446', 'cui_str': 'lamivudine and tenofovir disoproxil'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",613.0,0.189368,Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'Division of Infectious Diseases, HIV-AIDS Unit, Geneva University Hospitals, Geneva, Switzerland. Electronic address: alexandra.calmy@hcuge.ch.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Tovar Sanchez', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Dschang, Cameroon; Day Stay Hospital, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon; ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Mpoudi-Etame', 'Affiliation': 'Regional Military Hospital Number 1, Yaoundé, Cameroon.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Leroy', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Perrineau', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Lantche Wandji', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Tetsa Tata', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Pierette', 'Initials': 'P', 'LastName': 'Omgba Bassega', 'Affiliation': 'Cité Verte District Hospital, Cité Verte District, Yaoundé, Cameroon.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Abong Bwenda', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Varloteaux', 'Affiliation': 'ANRS Cameroon site, Central Hospital of Yaoundé, Henri-Dunant, Yaoundé, Cameroon.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Tongo', 'Affiliation': 'Emerging and Re-emerging Diseases Research Centre, IMPM, Sise à Ngoa-Ekelle, Yaoundé, Cameroon.'}, {'ForeName': 'Eitel', 'Initials': 'E', 'LastName': 'Mpoudi-Ngolé', 'Affiliation': 'Emerging and Re-emerging Diseases Research Centre, IMPM, Sise à Ngoa-Ekelle, Yaoundé, Cameroon.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Montoyo', 'Affiliation': 'Office of International Research and Collaboration, ANRS Inserm, Paris, France.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Mercier', 'Affiliation': 'Office of Clinical Trial Safety, ANRS Inserm, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'LeMoing', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Reynes', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'TransVIHMI, University of Montpellier, IRD, INSERM, 34394 Montpellier, France; Montpellier University Hospital Centre, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30238-1']
2617,33010242,"Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study.","BACKGROUND


Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation.
METHODS


This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045.
FINDINGS


Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10 6  peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10 6  PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified.
INTERPRETATION


The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection.
FUNDING


National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.",2020,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","['Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites', '11 centres in the USA and one centre in Rwanda', 'healthy, HIV-uninfected adults (TRAVERSE', '201 participants who were enrolled and randomly assigned']","['HIV or placebo', 'tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos', 'heterologous HIV vaccine regimens', 'placebos again administered to the placebo', 'placebo', 'adenovirus 26 (Ad26)-vectored vaccine and placebo']","['clade C Env binding antibodies', 'total IgG titres', 'Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events', 'Safety and immunogenicity', 'adverse events', 'IFNγ ELISPOT responses', 'safety, tolerability, and immunogenicity', 'Env-specific CD4+ T-cell response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]","[{'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",,0.625106,"Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups.","[{'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: lbaden@bwh.harvard.edu.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Mann', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Callewaert', 'Affiliation': 'Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Rwanda Zambia HIV Research Group, Kigali, Rwanda.'}, {'ForeName': 'Johannes P', 'Initials': 'JP', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research and Development, Titusville, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30229-0']
2618,33014738,"Comparing the Effects of Yarrow, Honey, and Breast Milk for Healing Nipple Fissure.","Background


Nipple fissure is a common problem among breastfeeding women, which can lead to early cessation of breastfeeding. Because of the lack of effective treatment and given the approved efficacy of honey and yarrow on sore healing, this study was conducted to evaluate and compare the effects of yarrow, honey, and breast milk on the treatment of nipple fissure.
Materials and Methods


This study was a three-group clinical trial, and sampling was conducted at Sina breastfeeding counseling center from September 2016 to March 2018 in Sirjan, Iran, using a target-based method. The sample size consisted of 150 individuals who were randomly assigned into three groups as topical use of yarrow, the mountain honey, and breast milk after obtaining the written informed consent. The correct method of breastfeeding and using materials were instructed to these three groups on the 1 st , 3 rd , and 7 th  days, where the Storr scale was completed by the researcher.
Results


Friedman test showed that, in these three groups of yarrow (χ 2  = 92.19, df = 2,  p  < 0.001), honey (χ 2  = 93.29, df = 2,  p  < 0.001), and breast milk (χ 2  = 90.51, df = 2,  p  < 0.001)); severity of fissure had a significant reduction. Nevertheless, Kruskal-Wallis test revealed no significant difference among the severity of fissure scores in these three groups ( p  > 0.05).
Conclusions


Use of honey, yarrow, and breast milk can be recommended to women in breastfeeding counseling and pharmaceutical companies can be advised to use honey and yarrow in the preparation of anti-fissure creams.",2020,"Results


Friedman test showed that, in these three groups of yarrow (χ 2  = 92.19, df = 2,  p  < 0.001), honey (χ 2  = 93.29, df = 2,  p  < 0.001), and breast milk (χ 2  = 90.51, df = 2,  p  < 0.001)); severity of fissure had a significant reduction.","['Sina breastfeeding counseling center from September 2016 to March 2018 in Sirjan, Iran, using a target-based method', '150 individuals']","['Yarrow, Honey, and Breast Milk']",['severity of fissure scores'],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0771936', 'cui_str': 'Yarrow flower extract'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0180817,"Results


Friedman test showed that, in these three groups of yarrow (χ 2  = 92.19, df = 2,  p  < 0.001), honey (χ 2  = 93.29, df = 2,  p  < 0.001), and breast milk (χ 2  = 90.51, df = 2,  p  < 0.001)); severity of fissure had a significant reduction.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Firouzabadi', 'Affiliation': 'Depatment of Midwifery, Sirjan School of Medical Sciences, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Naimeh', 'Initials': 'N', 'LastName': 'Pourramezani', 'Affiliation': 'Depatment of Nursing, Sirjan School of Medical Sciences, Sirjan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Balvardi', 'Affiliation': 'Instructor of Biostatistics, Sirjan School of Medical Sciences, Sirjan, Iran.'}]",Iranian journal of nursing and midwifery research,['10.4103/ijnmr.IJNMR_133_19']
2619,33014757,The Relationship between Pain and Vascular Function Biomarkers in Dysmenorrheal University Students.,"Our aim was to establish if the secretion of contactin 1 (CNTN-1), a widely researched pain biomarker correlates with the severity of dysmenorrhea and circulating levels of vascular cell adhesion molecule 1 (VCAM-1) and angiotensin II (ANG-II). This study was a longitudinal randomized clinical study that involved 95 female students between 17-25 years. The control participant group were students who, without medications, had not experienced dysmenorrhea, while the inclusion criteria were primary dysmenorrhea without medications. Data was collected using demographic questionnaires that also contained the Numeric Rating Scale (NRS-11), while blood samples were collected for analysis of CNTN-1, VCAM-1 and ANG-II by ELISA. The participants' mean BMI's across the four pain strata were between 16.60-38.43 kg/m 2  and in addition to age and menarche, showed no correlation to either the NRS-11 scale (r=-0.01214) or their CNTN-1 levels (r=0.009622). The severe dysmenorrhea group showed statistically higher (p<0.0001) and positive correlation to systolic (r=0.7304) and diastolic (0.6588) blood pressures. The contactin 1 levels (7.00-55.70 ng/mL) increased with higher menstrual pain and as the pain increased, so did the mean VCAM-1 and ANG-II levels (p<0.0001). A positive linear correlation (r=0.9691) was observed between the NRS-11 scale of the participants and their CNTN-1 activities while the CNTN-1 levels positively correlated with their VCAM-1 (r=0.9334) and ANG-II (r=0.8746) secretion. In summary, the severity of dysmenorrheal pain elevates the contactin 1 levels which affects their vascular health and blood pressure.",2020,"The contactin 1 levels (7.00-55.70 ng/mL) increased with higher menstrual pain and as the pain increased, so did the mean VCAM-1 and ANG-II levels","['Dysmenorrheal University Students', '95 female students between 17-25 years', 'control participant group were students who, without medications, had not experienced dysmenorrhea, while the inclusion criteria were primary dysmenorrhea without medications']",[],"['Pain and Vascular Function Biomarkers', 'Numeric Rating Scale (NRS-11), while blood samples', 'NRS-11 scale', 'higher menstrual pain', ""mean BMI's across the four pain strata"", 'mean VCAM-1 and ANG-II levels', 'vascular health and blood pressure', 'positive correlation to systolic (r=0.7304) and diastolic (0.6588) blood pressures', 'pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",95.0,0.0446155,"The contactin 1 levels (7.00-55.70 ng/mL) increased with higher menstrual pain and as the pain increased, so did the mean VCAM-1 and ANG-II levels","[{'ForeName': 'Uche Chinedu', 'Initials': 'UC', 'LastName': 'Njoku', 'Affiliation': 'Department of Biochemistry, University of Port Harcourt, Choba, Rivers State, Nigeria.'}, {'ForeName': 'Peter Uchenna', 'Initials': 'PU', 'LastName': 'Amadi', 'Affiliation': 'Department of Biochemistry, Imo State University, Owerri, Imo State, Nigeria.'}, {'ForeName': 'Emmanuel Nnabugwu', 'Initials': 'EN', 'LastName': 'Agomuo', 'Affiliation': 'Department of Biochemistry, Imo State University, Owerri, Imo State, Nigeria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bhebhe', 'Affiliation': 'Department of Biochemistry, Midlands State University, Gweru, Zimbabwe.'}]",Chonnam medical journal,['10.4068/cmj.2020.56.3.186']
2620,33014770,Exploratory Study of a CT Radiomics Model for the Classification of Small Cell Lung Cancer and Non-small-Cell Lung Cancer.,"Background:  Radiomics can quantify tumor phenotypic characteristics non-invasively by applying feature algorithms to medical imaging data. In this study, we investigated the association between radiomics features and the tumor histological subtypes, and we aimed to establish a nomogram for the classification of small cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC).  Methods:  This was a retrospective single center study. In total, 468 cases including 202 patients with SCLC and 266 patients with NSCLC were enrolled in our study, and were randomly divided into a training set ( n  = 327) and a validation set ( n  = 141) in a 7:3 ratio. The clinical data of the patients, including age, sex, smoking history, tumor maximum diameter, clinical stage, and serum tumor markers, were collected. All patients underwent enhanced computed tomography (CT) scans, and all lesions were pathologically confirmed. A radiomics signature was generated from the training set using the least absolute shrinkage and selection operator algorithm. Independent risk factors were identified by multivariate logistic regression analysis, and a radiomics nomogram based on the radiomics signature and clinical features was constructed. The capability of the nomogram was evaluated in the training set and validated in the validation set.  Results:  Fourteen of 396 radiomics parameters were screened as important factors for establishing the radiomics model. The radiomics signature performed well in differentiating SCLC and NSCLC, with an area under the curve (AUC) of 0.86 (95% CI: 0.82-0.90) in the training set and 0.82 (95% CI: 0.75-0.89) in the validation set. The radiomics nomogram had better predictive performance [AUC = 0.94 (95% CI: 0.90-0.98) in the validation set] than the clinical model [AUC = 0.86 (95% CI: 0.80-0.93)] and the radiomics signature [AUC = 0.82 (95% CI: 0.75-0.89)], and the accuracy was 86.2% (95% CI: 0.79-0.92) in the validation set.  Conclusion:  The enhanced CT radiomics signature performed well in the classification of SCLC and NSCLC. The nomogram based on the radiomics signature and clinical factors has better diagnostic performance for the classification of SCLC and NSCLC than the simple application of the radiomics signature.",2020,The nomogram based on the radiomics signature and clinical factors has better diagnostic performance for the classification of SCLC and NSCLC than the simple application of the radiomics signature.,"['In total, 468 cases including 202 patients with SCLC and 266 patients with NSCLC']","['CT Radiomics Model', 'enhanced computed tomography (CT) scans']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],468.0,0.030097,The nomogram based on the radiomics signature and clinical factors has better diagnostic performance for the classification of SCLC and NSCLC than the simple application of the radiomics signature.,"[{'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Shunli', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Chuanyu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Hualong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yabin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Wenjian', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Ultrasound, The Affiliated Hospital of Qingdao University, Qingdao, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.01268']
2621,33014797,Effect of Exercise Training on Exercise Tolerance and Level of Oxidative Stress for Head and Neck Cancer Patients Following Chemotherapy.,"Background


Chemotherapy decreases fitness performance via repression of cardiopulmonary function and oxidative stress. This study was designed to investigate whether exercise intervention could improve exercises capacity and reduce systemic oxidative stress in patients with head and neck (H&N) cancer receiving chemotherapy.
Methods


This is a single-center study. Forty-two H&N cancer patients who were undergoing chemotherapy were recruited in this study. An 8-week exercise intervention was performed by conducting the combination of aerobic and resistance exercise 3 days a week. The exercise training was conducted by a physiotherapist. The exercise capacity and exercise responses were measured from blood pressure (BP) and heart rate (HR). Oxidative stress markers from human plasma, such as total antioxidant capacity, 8-hydroxy-2'-deoxyguanosine, malondialdehyde, and carbonyl content, were tested by activity kits.
Results


We provide compelling evidence that exercise training ameliorated exercise responses and increased exercise capacity by repressing resting BP and increasing 1- and 3-min BP recovery. We also found the resting HR was reduced, and the 1- and 3-min HR recovery was increased after exercise training. In addition, the rating of perceived exertion after the peak exercise was reduced after exercise intervention. We also found that exercise training repressed oxidative stress markers by elevation of total antioxidant capacity and suppression of 8-OHd and carbonyl content in plasma.
Discussion


We clearly demonstrate that exercise can promote exercise capacity and reduce oxidative stress in H&N cancer patients receiving chemotherapy, which might guide new therapeutic approaches for cancer patients, especially those undergoing chemotherapy.",2020,"We also found that exercise training repressed oxidative stress markers by elevation of total antioxidant capacity and suppression of 8-OHd and carbonyl content in plasma.
","['H&N cancer patients receiving', 'Forty-two H&N cancer patients who were undergoing', 'patients with head and neck', 'Head and Neck Cancer Patients Following Chemotherapy']","['\n\n\nChemotherapy', 'exercise training', 'exercise intervention', 'chemotherapy', 'Exercise Training']","['systemic oxidative stress', 'Exercise Tolerance and Level of Oxidative Stress', 'total antioxidant capacity and suppression of 8-OHd and carbonyl content in plasma', 'oxidative stress', 'resting HR', 'blood pressure (BP) and heart rate (HR', 'exercise capacity and exercise responses', '1- and 3-min HR recovery', ""total antioxidant capacity, 8-hydroxy-2'-deoxyguanosine, malondialdehyde, and carbonyl content""]","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",42.0,0.0420018,"We also found that exercise training repressed oxidative stress markers by elevation of total antioxidant capacity and suppression of 8-OHd and carbonyl content in plasma.
","[{'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Graduate Institute of Clinical Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Ching-Hsia', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hui-Ching', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsin-Lun', 'Initials': 'HL', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yan-Jhen', 'Initials': 'YJ', 'LastName': 'Lu', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kun-Ling', 'Initials': 'KL', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Frontiers in oncology,['10.3389/fonc.2020.01536']
2622,33015116,Effects of Krill Oil and Race Distance on Serum Choline and Choline Metabolites in Triathletes: A Field Study.,"Choline is an essential nutrient that has been implicated in athletic performance due to its role in maintaining normal muscle function. The concentration of free choline in serum may decrease during long-distance high-intensity exercise, yet few nutritional strategies to counteract this potentially performance-depleting loss in choline have been investigated outside the laboratory. This exploratory field study was performed to investigate if pre-race supplementation with phosphatidylcholine from krill oil can counteract the expected drop in choline and some of its metabolites during triathlon competitions. Forty-seven triathletes, 12 females and 35 males ranging in age from 25 to 61 years, were recruited from participants in the Ironman-distance Norseman Xtreme triathlon and the Sprint/Olympic-distance Oslo Triathlon. Twenty-four athletes were randomly allocated to the krill oil group, receiving 4 g of Superba Boost ™ krill oil daily for 5 weeks prior to the race, and 23 athletes were randomly allocated to the placebo group, receiving 4 g of mixed vegetable oil daily. Blood samples were obtained before the race, immediately after completion of the race, and the day after the race for analysis of choline and its metabolites. The results showed that serum choline concentrations significantly decreased from pre-race to race finish in all races, with a more pronounced decrease observed in the Ironman-distance Norseman Xtreme triathlon (34% decrease) relative to the Sprint/Olympic-distance Oslo Triathlon (15% decrease). A reduction in betaine was also observed, while dimethylglycine (DMG) concentrations remained stable across all time points. Significantly higher concentrations of choline (9.4% on average) and DMG (21.4% on average) were observed in the krill oil compared to the placebo group, and the krill oil group showed a significantly greater increase in serum choline following race completion. In conclusion, krill oil may help to prevent that circulating choline concentrations become limiting during endurance competitions.",2020,"Significantly higher concentrations of choline (9.4% on average) and DMG (21.4% on average) were observed in the krill oil compared to the placebo group, and the krill oil group showed a significantly greater increase in serum choline following race completion.","['Forty-seven triathletes, 12 females and 35 males ranging in age from 25 to 61 years, were recruited from participants in the Ironman-distance Norseman Xtreme triathlon and the Sprint/Olympic-distance Oslo Triathlon', 'Triathletes', 'Twenty-four athletes']","['placebo group, receiving 4 g of mixed vegetable oil daily', 'Krill Oil and Race Distance', 'placebo', 'krill oil group, receiving 4 g of Superba Boost ™ krill oil daily', 'phosphatidylcholine from krill oil']","['dimethylglycine (DMG) concentrations', 'DMG', 'Serum Choline and Choline Metabolites', 'serum choline', 'serum choline concentrations']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042438', 'cui_str': 'Vegetable oil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}]","[{'cui': 'C0058265', 'cui_str': 'dimethylglycine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",24.0,0.0342107,"Significantly higher concentrations of choline (9.4% on average) and DMG (21.4% on average) were observed in the krill oil compared to the placebo group, and the krill oil group showed a significantly greater increase in serum choline following race completion.","[{'ForeName': 'Andreas B', 'Initials': 'AB', 'LastName': 'Storsve', 'Affiliation': 'Aker BioMarine Antarctic AS, Lysaker, Norway.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Johnsen', 'Affiliation': 'Aker BioMarine Antarctic AS, Lysaker, Norway.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Nyborg', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Melau', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jonny', 'Initials': 'J', 'LastName': 'Hisdal', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Burri', 'Affiliation': 'Aker BioMarine Antarctic AS, Lysaker, Norway.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00133']
2623,33015125,Sodium Bicarbonate Ingestion Improves Time-to-Exhaustion Cycling Performance and Alters Estimated Energy System Contribution: A Dose-Response Investigation.,"This study investigated the effects of two sodium bicarbonate (NaHCO 3 ) doses on estimated energy system contribution and performance during an intermittent high-intensity cycling test (HICT), and time-to-exhaustion (TTE) exercise. Twelve healthy males (stature: 1.75 ± 0.08 m; body mass: 67.5 ± 6.3 kg; age: 21.0 ± 1.4 years; maximal oxygen consumption: 45.1 ± 7.0 ml.kg.min -1 ) attended four separate laboratory visits. Maximal aerobic power (MAP) was identified from an incremental exercise test. During the three experimental visits, participants ingested either 0.2 g.kg -1  BM NaHCO 3  (SBC2), 0.3 g.kg -1  BM NaHCO 3  (SBC3), or 0.07 g.kg -1  BM sodium chloride (placebo; PLA) at 60 min pre-exercise. The HICT involved 3 × 60 s cycling bouts (90, 95, 100% MAP) interspersed with 90 s recovery, followed by TTE cycling at 105% MAP. Blood lactate was measured after each cycling bout to calculate estimates for glycolytic contribution to exercise. Gastrointestinal (GI) upset was quantified at baseline, 30 and 60 min post-ingestion, and 5 min post-exercise. Cycling TTE increased for SBC2 (+20.2 s;  p  = 0.045) and SBC3 (+31.9 s;  p  = 0.004) compared to PLA. Glycolytic contribution increased, albeit non-significantly, during the TTE protocol for SBC2 (+7.77 kJ;  p  = 0.10) and SBC3 (+7.95 kJ;  p  = 0.07) compared to PLA. GI upset was exacerbated post-exercise after SBC3 for nausea compared to SBC2 and PLA ( p  < 0.05), whilst SBC2 was not significantly different to PLA for any symptom ( p  > 0.05). Both NaHCO 3  doses enhanced cycling performance and glycolytic contribution, however, higher doses may maximize ergogenic benefits.",2020,"GI upset was exacerbated post-exercise after SBC3 for nausea compared to SBC2 and PLA ( p  < 0.05), whilst SBC2 was not significantly different to PLA for any symptom ( p  > 0.05).",['Twelve healthy males (stature: 1.75 ± 0.08 m; body mass: 67.5 ± 6.3 kg; age: 21.0 ± 1.4 years; maximal oxygen consumption: 45.1 ± 7.0 ml.kg.min -1 ) attended four separate laboratory visits'],"['Sodium Bicarbonate Ingestion', 'sodium bicarbonate (NaHCO 3 ', 'BM sodium chloride (placebo; PLA']","['SBC2', 'Gastrointestinal (GI) upset', 'intensity cycling test (HICT), and time-to-exhaustion (TTE) exercise', 'Maximal aerobic power (MAP', 'Glycolytic contribution', 'nausea', 'SBC3', 'Time-to-Exhaustion Cycling Performance', 'Blood lactate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517417', 'cui_str': '0.08'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",12.0,0.0675636,"GI upset was exacerbated post-exercise after SBC3 for nausea compared to SBC2 and PLA ( p  < 0.05), whilst SBC2 was not significantly different to PLA for any symptom ( p  > 0.05).","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Gurton', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Science, University of Essex, Colchester, United Kingdom.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Gough', 'Affiliation': 'Research Centre for Life and Sport Sciences (CLaSS) School of Health Sciences, Birmingham City University, Birmingham, United Kingdom.'}, {'ForeName': 'S Andy', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Sports Nutrition and Performance Group, Department of Sport and Physical Activity, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Faghy', 'Affiliation': 'Human Sciences Research Centre, University of Derby, Derby, United Kingdom.'}, {'ForeName': 'Katharine E', 'Initials': 'KE', 'LastName': 'Reed', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Science, University of Essex, Colchester, United Kingdom.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00154']
2624,33015129,The Ketogenic Diet in the Treatment of Post-concussion Syndrome-A Feasibility Study.,"Concussion is the most common form of mild traumatic brain injury (mTBI). Although most patients' symptoms resolve within a month, patients with post-concussion syndrome (PCS) may continue to experience symptoms for years and have limited treatment options. This pilot study assessed the feasibility and symptom-related effects of a ketogenic diet (KD) in patients with PCS symptoms. The Ketogenic Diet in Post-Concussion Syndrome (KD-PCS) was a single-arm trial of a 2-month KD high in non-starchy vegetables and supplemented with medium-chain triglyceride (MCT) oil. Macronutrient targets were ≥70% fat, ≤10% carbohydrate, and the remainder as protein as energy. We assessed feasibility by daily self-reported measure of urine acetoacetate and collection of 3-day food records and serum beta-hydroxybutyrate at multiple timepoints. We assessed symptoms by administering the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and Modified Balance Error Scoring System (M-BESS) at baseline and month 2 and the Post-Concussion Symptom Scale (PCSS) at baseline, month 1, and month 2. Fourteen participants enrolled in the KD-PCS. Twelve participants completed the study and 11 implemented the KD (73% fat, 9% carbohydrate, and 18% protein) and achieved ketosis. One participant complained of MCT-related diarrhea that resolved and another reported nausea and fatigue that resulted in withdrawal from the study. Among compliant participants, the visual memory domain of the ImPACT improved by 12 points ( p  = 0.02) and PCSS scores improved by 9 points, although not statistically significant. This pilot trial suggests that the KD is a feasible experimental treatment for PCS and justifies further study of its efficacy.",2020,"Among compliant participants, the visual memory domain of the ImPACT improved by 12 points ( p  = 0.02) and PCSS scores improved by 9 points, although not statistically significant.","['Twelve participants completed the study and 11 implemented the KD (73% fat, 9% carbohydrate, and 18% protein) and achieved ketosis', 'patients with PCS symptoms', 'Fourteen participants enrolled in the KD-PCS']","['medium-chain triglyceride (MCT) oil', 'ketogenic diet (KD', 'Ketogenic Diet']","['Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and Modified Balance Error Scoring System (M-BESS', 'visual memory domain of the ImPACT', 'PCSS scores', 'Post-Concussion Symptom Scale (PCSS', 'nausea and fatigue']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",14.0,0.035739,"Among compliant participants, the visual memory domain of the ImPACT improved by 12 points ( p  = 0.02) and PCSS scores improved by 9 points, although not statistically significant.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Rippee', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center for Concussion Management, University of Kansas Health System, Kansas City, KS, United States.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Taylor', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00160']
2625,33015144,The combination of inspiratory muscle training and high-flow nasal cannula oxygen therapy for promoting weaning outcomes in difficult-to-wean patients: protocol for a randomised controlled trial.,"Background


According to the literature, 20-30% of intubated patients are difficult to wean off mechanical ventilation and have a prolonged intensive care unit (ICU) stay with detrimental effects on muscle strength, functional ability and quality of life. Inspiratory muscle training (IMT)  via  a threshold device has been proposed as an effective exercise for minimising the effects of mechanical ventilation on respiratory muscles of critically ill patients with prolonged weaning. In addition, high-flow nasal cannula (HFNC) oxygen has been proved to provide efficient support for both high- and low-risk patients after extubation, thus preventing re-intubation.
Material and methods


A randomised controlled trial was designed to assess the efficacy of combining IMT and HFNC as therapeutic strategies for patients with high risk for weaning failure. Once patients with prognostic factors of difficult weaning are awake, ventilated with support settings and cooperative, they will be randomised to one of the two following study groups: intervention group (IMT and HFNC) and control group (IMT and Venturi mask). IMT will start as soon as possible. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from ICU. The primary outcome is the rate of weaning failure. Secondary outcomes are maximal inspiratory and expiratory strength, endurance of respiratory muscles, global muscle strength, functional ability and quality of life along with duration of ventilation (days) and ICU and hospital length of stay.
Conclusion


The present study could significantly contribute to knowledge of how best to treat patients with difficult weaning and high risk of re-intubation.",2020,"Secondary outcomes are maximal inspiratory and expiratory strength, endurance of respiratory muscles, global muscle strength, functional ability and quality of life along with duration of ventilation (days) and ICU and hospital length of stay.
","['patients with difficult weaning and high risk of re-intubation', 'critically ill patients with prolonged weaning', 'difficult-to-wean patients', 'patients with high risk for weaning failure']","['mechanical ventilation', 'IMT', 'IMT intervention', 'IMT and HFNC', 'Inspiratory muscle training (IMT)  via  a threshold device', 'inspiratory muscle training and high-flow nasal cannula oxygen therapy', 'high-flow nasal cannula (HFNC) oxygen', 'intervention group (IMT and HFNC) and control group (IMT and Venturi mask']","['maximal inspiratory and expiratory strength, endurance of respiratory muscles, global muscle strength, functional ability and quality of life along with duration of ventilation (days) and ICU and hospital length of stay', 'rate of weaning failure', 'muscle strength, functional ability and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1868713', 'cui_str': 'Weaning failure'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998195', 'cui_str': 'Venturi mask'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1868713', 'cui_str': 'Weaning failure'}]",,0.13445,"Secondary outcomes are maximal inspiratory and expiratory strength, endurance of respiratory muscles, global muscle strength, functional ability and quality of life along with duration of ventilation (days) and ICU and hospital length of stay.
","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Patsaki', 'Affiliation': 'Physiotherapy Dept, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christakou', 'Affiliation': 'Physiotherapy Dept, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Emmanouel', 'Initials': 'E', 'LastName': 'Papadopoulos', 'Affiliation': 'Physiotherapy Dept, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Katartzi', 'Affiliation': 'Physiotherapy Dept, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Kouvarakos', 'Affiliation': 'Physiotherapy Dept, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Siempos', 'Affiliation': '1st Critical Care Dept, National and Kapodistrian University of Athens, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tsimouris', 'Affiliation': 'Care and Rehabilitation Center ""Kallisto"", Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Skoura', 'Affiliation': 'Metropolitan Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Xatzimina', 'Affiliation': 'Dept of Physiotherapy, University of West Attica, Athens, Greece.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Malachias', 'Affiliation': '1st Critical Care Dept, National and Kapodistrian University of Athens, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Νikolaos', 'Initials': 'Ν', 'LastName': 'Koulouris', 'Affiliation': '1st Respiratory Dept, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Grammatopoulou', 'Affiliation': 'Dept of Physiotherapy, University of West Attica, Athens, Greece.'}, {'ForeName': 'Spiros', 'Initials': 'S', 'LastName': 'Zakinthinos', 'Affiliation': '1st Critical Care Dept, National and Kapodistrian University of Athens, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Ischaki', 'Affiliation': '1st Critical Care Dept, National and Kapodistrian University of Athens, General Hospital of Athens ""Evaggelismos"", Athens, Greece.'}]",ERJ open research,['10.1183/23120541.00088-2020']
2626,33015294,Evaluation of the efficacy and safety of cow placenta extract lotion versus minoxidil 2% in the treatment of female pattern androgenetic alopecia.,"Background


Placenta extract has been shown to improve androgenetic alopecia (AGA) by inducing the anagen phase and increasing hair follicle density and size.
Objective


This study aimed to evaluate the safety and efficacy of cow placenta extract lotion compared with topical minoxidil 2% as a gold standard treatment for female pattern AGA.
Methods


In this double-blind, randomized controlled trial, a total of 90 women with AGA were enrolled and randomly assigned to receive either topical minoxidil 2% or cow placenta solutions. At the end of the sixth month, the number of hair follicles was evaluated using a trichoscope and compared with the baseline. Global photographic review was also conducted by a blinded dermatologist.
Results


By the end of the sixth month, there was an increase in total hair count in the specified area in both groups. The mean increase in hair count was 10.9 ± 5.74 and 10.2 ± 6.5 for minoxidil and cow placenta groups, respectively ( p  = .63). The percentage of patients who were rated as having moderate or marked growth was 44.2% and 32.2% in the cow placenta and minoxidil groups, respectively ( p  = .90).
Limitations


The study limitations were the limited number of cases, short duration of treatment, and the fact that none of our participants volunteered to undergo a biopsy to evaluate microscopic changes.
Conclusions


Cow placenta hair-tonic lotion can be as effective as minoxidil 2% for female pattern AGA.",2020,"By the end of the sixth month, there was an increase in total hair count in the specified area in both groups.","['90 women with AGA', 'female pattern androgenetic alopecia', 'female pattern AGA']","['cow placenta extract lotion', 'topical minoxidil 2% or cow placenta solutions', 'topical minoxidil', 'minoxidil']","['hair count', 'safety and efficacy', 'number of hair follicles', 'androgenetic alopecia (AGA', 'total hair count']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0730881', 'cui_str': 'Regaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221971', 'cui_str': 'Hair follicle structure'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",90.0,0.0854307,"By the end of the sixth month, there was an increase in total hair count in the specified area in both groups.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Barat', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Abdollahimajd', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Dadkhahfar', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Moravvej', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2020.04.012']
2627,33015323,'Four-position method' makes beginner endoscopists aware of spatial positioning of the left hand to master upper gastrointestinal endoscopy.,"Background and study aims   We developed a novel ""four-position method"" for facilitating endoscopy of the upper gastrointestinal tract, and this study aimed to verify its usefulness for beginner endoscopists.  Methods   Medical students (n = 121) were divided into three groups. A simulator subsequently was used to perform endoscopy. Group A was taught how to hold the endoscope and move the dial; Group B was taught the ""four-position method""; and Group C, in addition to being taught the ""four-position method,"" was permitted to use an endoscope before introduction to the simulator. In each group, the transit time to various parts of the upper digestive tract was recorded in addition to the time to grasp a clip in the stomach with the forceps. We also surveyed the groups with respect to their impression of the difficulty level of endoscopic operation before and after instructions.  Results   Transit time to the cardia was no different among the groups; however, with regard to other targets, Group C reached the sites significantly more quickly than did Groups A and B. Time to clip grasping was significantly shorter in Groups B and C than in Group A. Regarding the impression of the difficulty level, significantly more students in Groups B and C compared to Group A felt that endoscopy was easier after instructions.  Conclusion   Learning the ""four-position method"" made it possible to achieve stable endoscopic manipulation at an early stage and improve subsequent endoscopic procedures.",2020,"Learning the ""four-position method"" made it possible to achieve stable endoscopic manipulation at an early stage and improve subsequent endoscopic procedures.",['Methods\u2002  Medical students (n\u200a=\u200a121'],[],"['transit time to various parts of the upper digestive tract', 'Transit time to the cardia']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]",[],"[{'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0226874', 'cui_str': 'Upper digestive tract structure'}, {'cui': 'C0007144', 'cui_str': 'Cardia structure'}]",121.0,0.0142928,"Learning the ""four-position method"" made it possible to achieve stable endoscopic manipulation at an early stage and improve subsequent endoscopic procedures.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Osawa', 'Affiliation': 'Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}]",Endoscopy international open,['10.1055/a-1197-6418']
2628,33015332,Dye chromoendoscopy leads to a higher adenoma detection in the duodenum and stomach in patients with familial adenomatous polyposis.,"Backround and study aims   Duodenal cancer is the cancer most often seen in patients with familial adenomatous polyposis (FAP) who have undergone risk-reducing colonic surgery. Almost all patients with FAP eventually develop duodenal adenomas and risk for duodenal cancer is up to 12 % with poor prognosis. In addition, there is a rising concern regarding increased gastric cancer risk in patients with FAP. Our aim was to enhance polyp detection by using CE (CE) with the application of indigo carmine dye.  Patient and methods   We conducted a prospective, blinded study of patients with FAP undergoing endoscopic examination of the upper gastrointestinal tract. First, a standard white-light examination (WLE) was done followed by an examination performed by an endoscopist who was blinded to the previous examination, using chromoendoscopy (CE) (0.4 % indigo carmine dye).  Results   Fifty patients were included in the study. Using WLE, a median number of 13 adenomas (range 0-90) was detected compared to 23 adenomas/patient (range 0-150;  P   < 0.0001) detected after staining, leading to a higher Spigelman stage in 16 patients (32 %;  P   = 0.0003). CE detected significantly more larger adenomas (> 10 mm) than WLE (12 vs. 19;  P   = 0.0391). In the gastric antral region, a median number of 0 adenomas (range 0-6) before and 0.5 adenomas (range 0-7) after staining (  P   = 0.0025) were detected.  Conclusion   This prospective endoscopic trial, to our knowledge the largest in patients with FAP, showed a significant impact of CE on adenoma detection and therapeutic management in the upper gastrointestinal tract. This leads to more intensive surveillance intervals.",2020,CE detected significantly more larger adenomas (> 10 mm) than WLE (12 vs. 19;  P   = 0.0391).,"['Fifty patients were included in the study', 'patients with familial adenomatous polyposis', 'patients with FAP undergoing endoscopic examination of the upper gastrointestinal tract', 'patients with FAP', 'patients with familial adenomatous polyposis (FAP) who have undergone risk-reducing colonic surgery']","['standard white-light examination (WLE', 'CE', 'CE (CE']","['median number of 0 adenomas', 'gastric cancer risk', 'larger adenomas', 'duodenal adenomas and risk for duodenal cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0153426', 'cui_str': 'Malignant tumor of duodenum'}]",50.0,0.0551386,CE detected significantly more larger adenomas (> 10 mm) than WLE (12 vs. 19;  P   = 0.0391).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hüneburg', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Heling', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Kaczmarek', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Heteren', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Olthaus', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital Bonn, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital Bonn, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Coch', 'Affiliation': 'Clinical study core unit (SZB), University Hospital Bonn, Germany.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lau', 'Affiliation': 'National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kristiansen', 'Affiliation': 'National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Weismüller', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Spier', 'Affiliation': 'National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aretz', 'Affiliation': 'National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Germany.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Strassburg', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nattermann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Bonn, Germany.'}]",Endoscopy international open,['10.1055/a-1220-6699']
2629,33015394,Subsurface enamel remineralization by Lyophilized Moringa leaf extract loaded varnish.,"Objective


The objective of this study was to investigate enamel remineralization using lyophilized extract from Moringa Oleifera Leaves (MOL).
Materials and methods


A total of seventy-five teeth were selected and randomly divided into 5 equal groups (n = 15). All teeth were air dried for 30 s, two windows (right and left) were drawn on the labial surface of each tooth. The right window was set as the control and no etching or treatment was performed. The left window was etched for 30 s for all five groups. After etching, group I received no treatment, group II received plain varnish, group III received fluoride varnish, and finally groups IV and V received plain varnish loaded with 50 mg/ml and 200 mg/ml of lyophilized MOL extract respectively. All samples were then immersed in artificial saliva for 14 days. The specimens were examined under scanning electron microscope (SEM) and energy dispersive x-ray (EDX).
Results


SEM micrographs revealed that MOL extract loaded-varnish groups IV & V showed the most re-establishment of normal enamel architecture. Elemental analysis of the treated surfaces of Groups IV and V showed the surfaces treated by MOL loaded-varnish groups had significantly higher Ca, P, and O deposition than the fluoride varnish group.
Conclusion


MOL might be considered as a biomimetic material capable of guiding enamel tissue remineralization.",2020,"Elemental analysis of the treated surfaces of Groups IV and V showed the surfaces treated by MOL loaded-varnish groups had significantly higher Ca, P, and O deposition than the fluoride varnish group.
",['A total of seventy-five teeth'],"['fluoride varnish', 'plain varnish', 'plain varnish loaded with 50 mg/ml and 200 mg/ml of lyophilized MOL extract respectively']","['Ca, P, and O deposition']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3464953', 'cui_str': 'Moringa oleifera leaf extract'}]","[{'cui': 'C0333562', 'cui_str': 'Deposition'}]",75.0,0.0177934,"Elemental analysis of the treated surfaces of Groups IV and V showed the surfaces treated by MOL loaded-varnish groups had significantly higher Ca, P, and O deposition than the fluoride varnish group.
","[{'ForeName': 'Sara H', 'Initials': 'SH', 'LastName': 'Younis', 'Affiliation': 'Lecturer of Conservative Dentistry, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt.'}, {'ForeName': 'Raneem F', 'Initials': 'RF', 'LastName': 'Obeid', 'Affiliation': 'Lecturer of Oral Biology, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Ammar', 'Affiliation': 'Lecturer of Biomaterials, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt.'}]",Heliyon,['10.1016/j.heliyon.2020.e05054']
2630,33026175,Intranasal insulin administration decreases cerebral blood flow in cortico-limbic regions: a neuropharmacological imaging study in normal and overweight males.,"AIM


To assess and compare the effects of 160 IU intranasal insulin (IN-INS) administration on regional cerebral blood flow (rCBF) in healthy male individuals with normal weight and overweight phenotypes.
METHODS


Thirty young male volunteers (mean age 25.9 years) were recruited and stratified into two cohorts based on body mass index; normal weight (18.5-24.9 kg/m 2  ) and overweight (25.0-29.9 kg/m 2  ). On separate mornings participants received 160 IU of IN-INS using an intranasal protocol and intranasal placebo as part of a double-blind crossover design. 30 mins following administration rCBF data was collected using a magnetic resonance imaging method called pseudocontinuous arterial spin labelling. Blood samples were collected to assess insulin sensitivity and changes over time in peripheral glucose, insulin and C-peptide.
RESULTS


Insulin sensitivity did not significantly differ between groups. When compared to placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus, in the overweight group only. No effect was seen in the normal weight group. Insula rCBF was greater in the overweight group vs. normal weight under placebo conditions only. Peripheral glucose and insulin levels were not affected by IN-INS. C-peptide levels in the normal weight group significantly dropped over time following IN-INS but not placebo.
CONCLUSION


Insulin-induced changes within key regions of the brain involved in gustation, memory and reward were observed in overweight healthy male individuals. Following placebo administration differences in gustatory regional CBF were observed between overweight and normal weight healthy individuals. This article is protected by copyright. All rights reserved.",2020,"When compared to placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus, in the overweight group only.","['normal and overweight males', 'cortico-limbic regions', 'healthy male individuals with normal weight and overweight phenotypes', 'overweight healthy male individuals', 'Thirty young male volunteers (mean age 25.9\u2009years) were recruited and stratified into two cohorts based on body mass index; normal weight (18.5-24.9\u2009kg/m 2  ) and overweight (25.0-29.9\u2009kg/m 2  ']","['intranasal protocol and intranasal placebo', 'placebo', 'Intranasal insulin', '160\u2009IU intranasal insulin (IN-INS']","['regional cerebral blood flow (rCBF', 'insulin sensitivity and changes over time in peripheral glucose, insulin and C-peptide', 'cerebral blood flow', 'Peripheral glucose and insulin levels', 'C-peptide levels', 'Insulin sensitivity', 'Insula rCBF', 'gustatory regional CBF']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0439678', 'cui_str': 'Gustatory'}]",30.0,0.385553,"When compared to placebo, IN-INS administration reduced rCBF in parts of the hippocampus, insula, putamen, parahippocampal gyrus and fusiform gyrus, in the overweight group only.","[{'ForeName': 'Jed O', 'Initials': 'JO', 'LastName': 'Wingrove', 'Affiliation': ""King's College London, Centre for Neuroimaging Sciences, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""King's College London, Centre for Neuroimaging Sciences, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Forbes', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, UK.""}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Swedrowska', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, UK.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Amiel', 'Affiliation': ""King's College London, Diabetes Research Group, King's College Hospital Campus, Weston Education Central, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""King's College London, Centre for Neuroimaging Sciences, London, UK.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14213']
2631,33026192,Gender differences in response to an opportunistic brief intervention for obesity in primary care: Data from the BWeL trial.,"Weight loss programmes appeal mainly to women, prompting calls for gender-specific programmes. In the United Kingdom, general practitioners (GPs) refer nine times as many women as men to community weight loss programmes. GPs endorsement and offering programmes systematically could reduce this imbalance. In this trial, consecutively attending patients in primary care with obesity were invited and 1882 were enrolled and randomized to one of two opportunistic 30-second interventions to support weight loss given by GPs in consultations unrelated to weight. In the support arm, clinicians endorsed and offered referral to a weight loss programme and, in the advice arm, advised that weight loss would improve health. Generalized linear mixed effects models examined whether gender moderated the intervention. Men took effective weight loss action less often in both arms (support: 41.6% vs 60.7%; advice: 12.1% vs 18.3%; odds ratio (OR) = 0.38, 95% confidence interval (CI), 0.27, 0.52, P < .001) but there was no evidence that the relative effect differed by gender (interaction P = .32). In the support arm, men accepted referral and attended referral less often, 69.3% vs 82.4%; OR = 0.48, 95% CI, 0.35, 0.66, P < .001 and 30.4% vs 47.6%; OR = 0.48, 95% CI, 0.36, 0.63, P < .001, respectively. Nevertheless, the gender balance in attending weight loss programmes closed to 1.6:1. Men and women attended the same number of sessions (9.7 vs 9.1 sessions, P = .16) and there was no evidence weight loss differed by gender (6.05 kg men vs 4.37 kg women, P = .39). Clinician-delivered opportunistic 30-second interventions benefits men and women equally and reduce most of the gender imbalance in attending weight loss programmes.",2020,"Men and women attended the same number of sessions (9.7 vs 9.1 sessions, P = .16) and there was no evidence weight loss differed by gender (6.05 kg men vs 4.37 kg women, P = .39).",['consecutively attending patients in primary care with obesity were invited and 1882 were enrolled'],"['opportunistic 30-second interventions to support weight loss given by GPs', 'Clinician-delivered opportunistic 30-second interventions']",['evidence weight loss'],"[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",1882.0,0.0823814,"Men and women attended the same number of sessions (9.7 vs 9.1 sessions, P = .16) and there was no evidence weight loss differed by gender (6.05 kg men vs 4.37 kg women, P = .39).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Tudor', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise, and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty Research Centre for Advances in Behavioural Science, Coventry University, Coventry, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",Clinical obesity,['10.1111/cob.12418']
2632,33026243,Efficacy of Ertugliflozin on Heart Failure-Related Events in Patients with Type 2 Diabetes Mellitus and Established Atherosclerotic Cardiovascular Disease: Results of the VERTIS CV Trial.,"Background:  In patients with type 2 diabetes mellitus (T2DM), sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure (HHF). We assessed the effect of ertugliflozin on HHF and related outcomes.  Methods:  VERTIS CV, a double-blind, placebo-controlled trial, randomized patients with T2DM and atherosclerotic cardiovascular (CV) disease to once-daily ertugliflozin 5 mg, 15 mg or placebo. Prespecified secondary analyses compared ertugliflozin (pooled doses) versus placebo on time to first event of HHF and composite of HHF/CV death, overall and stratified by prespecified characteristics. Cox proportional hazard modeling was used with the Fine and Gray method to account for competing mortality risk, and Andersen-Gill modeling to analyze total (first+recurrent) HHF and total HHF/CV death events.  Results:  8246 patients were randomized to ertugliflozin (n=5499) or placebo (n=2747); n=1958 (23.7%) had a history of heart failure (HF) and n=5006 (60.7%) had pre-trial ejection fraction (EF) available, including n=959 with EF≤45%. Ertugliflozin did not significantly reduce first HHF/CV death (HR, 0.88; 95% CI, 0.75, 1.03). Overall, ertugliflozin reduced risk for first HHF (HR, 0.70; 95% CI, 0.54, 0.90;  P =0.006). Prior HF did not modify this effect (HF: HR, 0.63; 95% CI, 0.44, 0.90; no HF: HR, 0.79; 95% CI, 0.54, 1.15;  P  interaction=0.40). In patients with HF, the risk reduction for first HHF was similar for those with reduced EF≤45% vs preserved EF>45% or unknown. However, in the overall population, the risk reduction tended to be greater for those with EF≤45% (HR, 0.48; 95% CI, 0.30, 0.76) versus EF>45% (HR, 0.86; 95% CI, 0.58, 1.29). Effect on risk for first HHF was consistent across most subgroups, but greater benefit of ertugliflozin was observed in three populations with baseline eGFR<60mL/min/1.73m 2 , albuminuria, and diuretic use (each  P  interaction<0.05). Ertugliflozin reduced total events of HHF (RR, 0.70; 95% CI, 0.56, 0.87) and total HHF/CV death (RR, 0.83; 95% CI, 0.72, 0.96).  Conclusions:  In patients with T2DM with or without baseline HF, ertugliflozin reduced risk for first and total HHF and total HHF/CV death, adding further support for the use of SGLT2 inhibitors in primary and secondary prevention of HHF.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT01986881.",2020,"Prior HF did not modify this effect (HF: HR, 0.63; 95% CI, 0.44, 0.90; no HF: HR, 0.79; 95% CI, 0.54, 1.15;  P  interaction=0.40).","['n=2747); n=1958 (23.7%) had a history of heart failure (HF) and n=5006 (60.7%) had pre-trial ejection fraction (EF) available, including n=959 with EF≤45', 'patients with type 2 diabetes mellitus (T2DM), sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure (HHF', '8246 patients', 'Patients with Type 2 Diabetes Mellitus and Established Atherosclerotic Cardiovascular Disease', 'patients with T2DM and atherosclerotic cardiovascular (CV) disease to once-daily']","['ertugliflozin', 'Ertugliflozin', 'placebo', 'ertugliflozin 5 mg, 15 mg or placebo']","['total HHF/CV death', 'risk reduction for first HHF', 'Heart Failure-Related Events', 'risk reduction', 'total events of HHF', 'reduce first HHF/CV death', 'time to first event of HHF and composite of HHF/CV death', 'risk for first HHF', 'benefit of ertugliflozin']","[{'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}]",8246.0,0.510293,"Prior HF did not modify this effect (HF: HR, 0.63; 95% CI, 0.44, 0.90; no HF: HR, 0.79; 95% CI, 0.54, 1.15;  P  interaction=0.40).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Unit of Cardiology, Karolinska Institute and Karolinska University Hospital Solna, Stockholm, Sweden.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Masiukiewicz', 'Affiliation': 'Pfizer Inc., Groton, CT.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Dagogo Jack', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT.'}, {'ForeName': 'Weichung J', 'Initials': 'WJ', 'LastName': 'Shih', 'Affiliation': 'Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA.'}, {'ForeName': 'Nilo B', 'Initials': 'NB', 'LastName': 'Cater', 'Affiliation': 'Pfizer Inc., New York, NY.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.050255']
2633,33026297,"The effect of gender, age and sports specialisation on isometric trunk strength in Greek high level young athletes.","Aim of the study was to compare the isometric strength of flexors and extensors trunk muscles between male and female elite adolescent athletes of different age and training experience. Absolute and relative trunk muscle isometric peak extension (PTE) and flexion (PTF) torque, as well as flexion/extension (F/E) ratio were evaluated in 388 elite adolescent athletes 188 males (Age: 15.4±1.8 years, Body height: 175.5±11.2 cm, Body mass: 68.8±14.5 kg, BMI: 22.1±0.3 kg/m 2 ) and 207 females (Age: 15.1±1.6 years, Body height: 166.8±7.8 cm, Body mass: 60.8±8.4 kg and BMI: 21.8±0.4 kg/m 2 ). Participants were assigned into seven different groups according to their sport specialisation (oars-paddle, swimming, contact-combat, team, racket, winter and mixed other sports). Significant effect of age (η 2 : 0.077-0.112, p < 0.05), gender (η 2 : 0.020-0.077; p < 0.05) and sport category factors (η 2 : 0.057-0.154. p < 0.005) for absolute/relative PTE, PTF and F/E ratio was found. The highest values were observed in contact-combat and the lowest in mixed other sports groups. F/E ratio significantly differs between the age groups, especially in female athletes. The present data suggest that TMSs and F/E ratio are highly affected by age, gender and sports specialisation in high level trained adolescents.",2020,"p < 0.005) for absolute/relative PTE, PTF and F/E ratio was found.","['male and female elite adolescent athletes of different age and training experience', '207 females (Age: 15.1±1.6\xa0years, Body height: 166.8±7.8 cm, Body mass: 60.8±8.4 kg and BMI: 21.8±0.4 kg/m 2 ', '388 elite adolescent athletes 188 males (Age: 15.4±1.8\xa0years', 'Greek high level young athletes']",[],"['absolute/relative PTE, PTF and F/E ratio', 'isometric trunk strength', 'Absolute and relative trunk muscle isometric peak extension (PTE) and flexion (PTF) torque, as well as flexion/extension (F/E) ratio']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",388.0,0.0295107,"p < 0.005) for absolute/relative PTE, PTF and F/E ratio was found.","[{'ForeName': 'Charilaos', 'Initials': 'C', 'LastName': 'Tsolakis', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}, {'ForeName': 'Theoharis', 'Initials': 'T', 'LastName': 'Simeonidis', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Georginis', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Cherouveim', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Methenitis', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Koulouvaris', 'Affiliation': 'School of Health Sciences, National and Kapodistrian University of Athens , Athens, Greece.'}]",Sports biomechanics,['10.1080/14763141.2020.1809699']
2634,33026515,The effect of preferred music on mental workload and laparoscopic surgical performance in a simulated setting (OPTIMISE): a randomized controlled crossover study.,"BACKGROUND


Worldwide, music is commonly played in the operation room. The effect of music on surgical performance reportedly has varying results, while its effect on mental workload and key surgical stressor domains has only sparingly been investigated. Therefore, the aim is to assess the effect of recorded preferred music versus operating room noise on laparoscopic task performance and mental workload in a simulated setting.
METHODS


A four-sequence, four-period, two-treatment, randomized controlled crossover study design was used. Medical students, novices to laparoscopy, were eligible for inclusion. Participants were randomly allocated to one of four sequences, which decided the exposure order to music and operation room noise during the four periods. Laparoscopic task performance was assessed through motion analysis with a laparoscopic box simulator. Each period consisted of ten alternating peg transfer tasks. To account for the learning curve, a preparation phase was employed. Mental workload was assessed using the Surgery Task Load Index. This study was registered with the Netherlands Trial Register (NL7961).
RESULTS


From October 29, 2019 until March 12, 2020, 107 participants completed the study, with 97 included for analyzation. Laparoscopic task performance increased significantly during the preparation phase. No significant beneficial effect of music versus operating room noise was observed on time to task completion, path length, speed, or motion smoothness. Music significantly decreased mental workload, reflected by a lower score of the total weighted Surgery Task Load Index in all but one of the six workload dimensions.
CONCLUSION


Music significantly reduced mental workload overall and of several previously identified key surgical stressor domains, and its use in the operating room is reportedly viewed favorably. Music did not significantly improve laparoscopic task performance of novice laparoscopists in a simulated setting. Although varying results have been reported previously, it seems that surgical experience and task demand are more determinative.",2020,"No significant beneficial effect of music versus operating room noise was observed on time to task completion, path length, speed, or motion smoothness.","['107 participants completed the study, with 97 included for analyzation', 'From October 29, 2019 until March 12, 2020', 'Medical students, novices to laparoscopy, were eligible for inclusion', 'A four-sequence, four-period, two-treatment']","['Music', 'recorded preferred music versus operating room noise']","['laparoscopic task performance and mental workload', 'mental workload and laparoscopic surgical performance', 'total weighted Surgery Task Load Index', 'Laparoscopic task performance', 'mental workload', 'laparoscopic task performance', 'Mental workload', 'time to task completion, path length, speed, or motion smoothness']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",,0.271679,"No significant beneficial effect of music versus operating room noise was observed on time to task completion, path length, speed, or motion smoothness.","[{'ForeName': 'Victor X', 'Initials': 'VX', 'LastName': 'Fu', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. v.fu@erasmusmc.nl.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Oomens', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent E E', 'Initials': 'VEE', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Karel J', 'Initials': 'KJ', 'LastName': 'Sleurink', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Willemijn M', 'Initials': 'WM', 'LastName': 'Borst', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Pascale E', 'Initials': 'PE', 'LastName': 'Wessels', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}]",Surgical endoscopy,['10.1007/s00464-020-07987-6']
2635,33026517,Extrahepatic biliary tract visualization using near-infrared fluorescence imaging with indocyanine green: optimization of dose and dosing time.,"BACKGROUND


The dose and dosing time of indocyanine green (ICG) vary among fluorescence cholangiography (FC) studies. The purpose of this prospective, randomized, exploratory clinical trial was to optimize the dose and dosing time of ICG.
METHODS


PubMed was searched to determine the optimal dose. To optimize the dosing time of ICG, a clinical trial was designed with two parts. The first part included patients with T tubes for more than 1 month. After the patient was injected with ICG, bile was collected at 10 time points to explore the change and trends of bile fluorescence intensity (FI). In addition, the results of the first experiment were used to setup a randomized controlled trial (RCT) that aimed to find the optimal dosing timing for ICG injections for laparoscopic cholecystectomy (LC). During surgery, imaging data were collected for analysis.
RESULTS


After performing a systematic review, the ICG injection dose for each patient in the clinical trial was 10 mg. Five patients were included in the first part of the study. Bile collected 8 h after ICG injection had a higher FI than bile collected at other time points (p < 0.05), and the FI of bile collected 20 h after ICG injection was nearly zero. In the second part of the experiment, 4 groups of patients (6 patients per group) were injected with 10 mg ICG at 8, 10, 12 and 14 h prior to surgery. The distribution of bile duct FI (p = 0.001), liver FI (p < 0.001), and common bile duct (CBD)-to-liver contrast (p = 0.001) were not the same in each group. Further analysis with the Bonferroni method revealed the following: (1) the FI of the CBD in the 8 h group was significantly different from that in the 14 h group (adjusted p < 0.001); (2) the liver FI of the 8 h group was higher than that of the 10 h group (adjusted p = 0.042) and the 14 h group (adjusted p < 0.001); and (3) the CBD-to-liver contrast of the 8 h group was lower than that of the 10 h group (adjusted p = 0.013) and the 14 h group (adjusted p = 0.001).
CONCLUSION


ICG FC enables the real-time identification of extrahepatic bile ducts. The optimal effect of FC can be achieved by performing 10 mg ICG injections 10 to 12 h prior to surgery.",2020,"The distribution of bile duct FI (p = 0.001), liver FI (p < 0.001), and common bile duct (CBD)-to-liver contrast (p = 0.001) were not the same in each group.","['Five patients were included in the first part of the study', 'patients with T tubes for more than 1\xa0month']","['ICG injections', 'indocyanine green (ICG', 'FC', 'ICG injections for laparoscopic cholecystectomy (LC', 'indocyanine green', 'ICG FC']","['CBD-to-liver contrast', 'distribution of bile duct FI', 'liver FI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175731', 'cui_str': 'T-tube'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0008307', 'cui_str': 'Cholangiogram'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0009437', 'cui_str': 'Common bile duct structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",5.0,0.031698,"The distribution of bile duct FI (p = 0.001), liver FI (p < 0.001), and common bile duct (CBD)-to-liver contrast (p = 0.001) were not the same in each group.","[{'ForeName': 'Qiangxing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Rou', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrine, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Jiefeng', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Yueyuan', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Zhaofeng', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': ""Department of Surgery, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, No. 1 Panfu Road, Yuexiu District, Guangzhou, 510180, Guangdong, China. weili139221@163.com.""}]",Surgical endoscopy,['10.1007/s00464-020-08058-6']
2636,33026537,Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study.,"PURPOSE


The management of knee pain secondary to meniscal tears with osteoarthritis is limited by the poor inherent healing potential of the meniscus. Previous studies have reported on the benefit of autologous micro-fragmented fat as a therapeutic for various knee pathologies. The goal of this prospective pilot study was to determine the safety and potential treatment effect of micro-fragmented adipose tissue injection for patients with knee pain secondary to osteoarthritis and meniscal tears who have failed conservative management.
METHODS


Twenty subjects with knee pain secondary to osteoarthritis with associated meniscal tear after failed conservative management were enrolled in the study. Numeric Pain Scale (NPS) and Knee Injury and Osteoarthritis Outcome Scale (KOOS) following ultrasound-guided intra-meniscal and intra-articular micro-fragmented adipose tissue injections were examined at three, six and 12 months.
RESULTS


The mean NPS revealed a significant decrease in patient pain at the 1-year time point compared with baseline (5.45 to 2.21, p < .001). Similarly, overall, mean KOOS symptoms significantly improved from 57.7 to 78.2 (p < .001), with all 4 KOOS subscales demonstrating significant improvement at the final one year follow-up. One subject developed uncomplicated cellulitis at the harvest site which was treated with oral antibiotics. Other complications were minor and mostly limited to adipose harvest.
CONCLUSION


This study demonstrated that micro-fragmented adipose tissue injected directly into a torn meniscus and knee joint using ultrasound guidance represents a safe and potentially efficacious treatment option for patients with knee pain suffering from degenerative arthritis and degenerative meniscal tears. A larger, randomized, controlled trial is warranted to determine efficacy.
TRIAL REGISTRATION


Clinicaltrials.org Identifier: NCT03714659.",2020,"Similarly, overall, mean KOOS symptoms significantly improved from 57.7 to 78.2 (p < .001), with all 4 KOOS subscales demonstrating significant improvement at the final one year follow-up.","['patients with knee pain secondary to osteoarthritis and meniscal tears who have failed conservative management', 'Twenty subjects with knee pain secondary to osteoarthritis with associated meniscal tear after failed conservative management were enrolled in the study', 'patients with knee pain suffering from degenerative arthritis and degenerative meniscal tears', 'patients with meniscus tears with osteoarthritis']","['micro-fragmented adipose tissue injected directly into a torn meniscus and knee joint using ultrasound guidance', 'micro-fragmented adipose tissue', 'micro-fragmented adipose tissue injection']","['Numeric Pain Scale (NPS) and Knee Injury and Osteoarthritis Outcome Scale (KOOS) following ultrasound-guided intra-meniscal and intra-articular micro-fragmented adipose tissue injections', 'mean KOOS symptoms', 'patient pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1275678', 'cui_str': 'Finding of tear meniscus'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",20.0,0.0306741,"Similarly, overall, mean KOOS symptoms significantly improved from 57.7 to 78.2 (p < .001), with all 4 KOOS subscales demonstrating significant improvement at the final one year follow-up.","[{'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Malanga', 'Affiliation': 'New Jersey Regenerative Institute LLC, 197 Ridgedale Ave Suite 210, Cedar Knolls, NJ, 07927, USA. gmalangamd@hotmail.com.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Chirichella', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, New Jersey Medical School, Rutgers University, Newark, NJ, USA.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Hogaboom', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Capella', 'Affiliation': 'New Jersey Regenerative Institute LLC, 197 Ridgedale Ave Suite 210, Cedar Knolls, NJ, 07927, USA.'}]",International orthopaedics,['10.1007/s00264-020-04835-z']
2637,33026658,Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention.,"BACKGROUND


In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood.
METHODS


From December 2017 to April 2019, 100 caregivers of HCT recipients were enrolled into a randomized clinical trial of BMT-CARE versus usual care. Caregivers completed self-report measures of QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment (before HCT) and 60 days after HCT. Causal mediation regression models were used to examine whether changes in coping and self-efficacy mediated intervention effects on QOL as well as depression and anxiety symptoms.
RESULTS


Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05). Similarly, reductions in 60-day depression and anxiety symptoms were partially mediated by improved coping and self-efficacy (indirect effect for depression, -1.19; SE, 0.42; 95% CI, -2.23 to -0.53; indirect effect for anxiety, -1.46; SE, 0.55; 95% CI, -2.52 to -0.43). Combined improvements in coping and self-efficacy accounted for 67%, 80%, and 39% of the total intervention effects on QOL and depression and anxiety symptoms, respectively.
CONCLUSIONS


Coping and self-efficacy are essential components of a brief psychosocial intervention that improves QOL and mood for caregivers of HCT recipients during the acute recovery period.
LAY SUMMARY


A 6-session program (BMT-CARE) focused on providing medical information, caregiving skills, and self-care and coping strategies has been previously reported to improve the quality of life and mood of caregivers of hematopoietic stem cell transplantation recipients in comparison with caregivers who receive care as usual. Using statistical models, this study suggests that learning coping skills and improving self-efficacy are the most essential components of this program that likely lead to better quality of life and mood for caregivers.",2020,"RESULTS


Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05).","['caregivers of HCT recipients during the acute recovery period', 'family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients', 'caregivers of stem cell transplant recipients', 'From December 2017 to April 2019, 100 caregivers of HCT recipients']","['6-session program (BMT-CARE', 'BMT-CARE versus usual care']","['QOL and depression and anxiety symptoms', 'Enhanced coping and self-efficacy', 'coping and self-efficacy', 'improved coping and self-efficacy', 'QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant', 'QOL and mood', 'quality of life (QOL), mood, coping skills, and self-efficacy', '60-day depression and anxiety symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0430127,"RESULTS


Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05).","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Waldman', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Showly', 'Initials': 'S', 'LastName': 'Nicholson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""D'Alotto"", 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.33191']
2638,33026685,New Simple Ultrasound-Guided Transforaminal Injection in Patients With Radiculopathy in the Lower Cervical Spine: A Computed Tomography-Controlled Study.,"OBJECTIVES


To evaluate the feasibility of a new simple ultrasound-guided transforaminal injection in patients with cervical radiculopathy.
METHODS


Ultrasound scans of the neck in a plastic model and in 5 unaffected participants were first performed to identify the intervertebral foramen. Then ultrasound-guided transforaminal injections were performed in 20 patients with radiculopathy in the lower cervical spine, and computed tomography was used to verify the accuracy. Complications, the visual analog score, and the neck disability index were assessed at 1 and 3 months after the injection.
RESULTS


Computed tomography confirmed that the needle tip was correctly placed in the intervertebral foramen in 88.5% (23 of 26) of injections. No immediate or short-term complications were observed in all patients. The visual analog score and neck disability index at 1 and 3 months were significantly lower than those before the injection (both P < .0001).
CONCLUSIONS


Ultrasound may be a feasible and accurate method to guide cervical transforaminal injection.",2020,"The visual analog score and neck disability index at 1 and 3 months were significantly lower than those before the injection (both P < .0001).
","['Patients With Radiculopathy in the Lower Cervical Spine', 'Ultrasound scans of the neck in a plastic model and in 5 unaffected participants were first performed to identify the intervertebral foramen', 'patients with cervical radiculopathy', '20 patients with']","['New Simple Ultrasound-Guided Transforaminal Injection', 'radiculopathy', 'new simple ultrasound-guided transforaminal injection']","['immediate or short-term complications', 'Complications, the visual analog score, and the neck disability index', 'visual analog score and neck disability index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",20.0,0.0262563,"The visual analog score and neck disability index at 1 and 3 months were significantly lower than those before the injection (both P < .0001).
","[{'ForeName': 'Yuexiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Departments of Ultrasound, the first center of Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.'}, {'ForeName': 'Yaqiong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Departments of Ultrasound, the first center of Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Departments Orthopedics, the first center of Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.'}, {'ForeName': 'Yizheng', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Anesthesia Operation Center, the first center of Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Pain Department, the first center of Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15523']
2639,33026689,Inhaled hypertonic saline after pediatric lung transplant-Caution required?,"Management of pulmonary infection following lung transplant is multifaceted and includes respiratory physiotherapy. Inhaled hypertonic saline (HTS) has been introduced as an adjunct to physiotherapy in pediatric transplant patients. There are no published studies investigating the use of HTS in this population. This study aimed to evaluate the effect of inhaled HTS, in the acute post-operative period, in pediatric lung transplant patients. A retrospective case-note review was completed at a single UK pediatric transplant center. An intervention group who received HTS was compared to a historical control group. Participants were frequency matched for age, gender, and diagnosis (14 per group); median age in years was 13.7(IQR 12.7-15.3) in the controls and 14.8(IQR 12.4-16.1) in the intervention group. Primary outcome was the requirement of invasive and non-invasive ventilation. Secondary outcomes included oxygen use and length of stay. Median days of invasive ventilation were shorter in the control group (1, 95% CI 1-1) compared to the intervention group (2, 95% CI 1-2.5) (P < .05). Days of non-invasive ventilation and oxygen were higher in the HTS group, but this was not statistically significant. The controls displayed shorter median length of stay (23 days, 95% CI 20-24) compared to the intervention group (31 days, 95% CI 24.5-39) (P < .05). The results of this small study provide uncertainty regarding the safety of inhaled hypertonic saline after lung transplant. There was a trend of poorer acute outcomes in patients who received HTS. However, the findings should be interpreted with caution and further investigation using larger samples is required.",2020,"The controls displayed shorter median length of stay (23 days, 95% CI 20-24) compared to the intervention group (31 days, 95% CI 24.5-39) (P < .05).","['single UK pediatric transplant center', 'pediatric transplant patients', 'Participants were frequency matched for age, gender, and diagnosis (14 per group); median age in years was 13.7(IQR 12.7-15.3) in the controls and 14.8(IQR 12.4-16.1) in the intervention group', 'pediatric lung transplant patients']","['HTS', 'Inhaled hypertonic saline (HTS', 'Inhaled hypertonic saline', 'inhaled HTS', 'hypertonic saline']","['requirement of invasive and non-invasive ventilation', 'Median days of invasive ventilation', 'oxygen use and length of stay', 'median length of stay']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.120313,"The controls displayed shorter median length of stay (23 days, 95% CI 20-24) compared to the intervention group (31 days, 95% CI 24.5-39) (P < .05).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Shkurka', 'Affiliation': 'Department of Physiotherapy, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Spencer', 'Affiliation': 'Department of Cardiothoracic Transplantation, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}]",Pediatric transplantation,['10.1111/petr.13843']
2640,33026700,The European Medicines Agency review of daratumumab (Darzalex) for the treatment of adult patients newly diagnosed with multiple myeloma.,"The use of daratumumab in combination with established regimens for the treatment of newly diagnosed Multiple Myeloma (MM) has recently been authorised by the European Medicines Agency based on results from 3 separate phase 3 randomized, active controlled open label studies which have confirmed enhanced efficacy and tolerability in both transplant ineligible (MMY3008 and MMY 3007) and eligible patients (MMY3006), without compromising transplant ability. Trial MMY3008 showed an improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone; the median PFS had not been reached in the daratumumab arm and was 31.9 months in the control arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001). Trial MMY3007 showed an improvement in PFS when daratumumab was added to bortezomib, melphalan and prednisone compared with bortezomib, melphalan and prednisone; PFS had not been reached in the daratumumab arm and was 18.1 months in the control arm (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001). In trial MMY3006 daratumumab added to bortezomib, thalidomide and dexamethasone was compared with bortezomib, thalidomide and dexamethasone as induction and consolidation treatment prior to autologous stem cell transplant. The stringent Complete Response (sCR) rate at Day 100 post-transplant in the daratumumab group was 29% compared with 20% in the control group [odds ratio (OR): 1.60, 1.21-2.12 p: 0.0010]. Overall adverse events were manageable, with an increased rate of neutropenia and infections in the daratumumab arms. Regulatory Assessment of efficacy and safety results from trials MMY3006, MMY3007 and MMY3008 confirmed a positive benefit risk ratio leading to an approval of the extensions of indication. IMPLICATIONS FOR PRACTICE: A set of extensions of indication was recently approved for daratumumab (Darzalex) in the setting of newly diagnosed multiple myeloma in combination with established regimens. Results of MMY3006, MMY3007 and MMY3008 trials have shown enhanced efficacy and a favorable side effect profile of several daratumumab-based combinations in both transplant ineligible and eligible patients, without compromising transplant ability. The combination of daratumumab with either lenalidomide and low dose dexamethasone or bortezomib, melphalan and prednisone were approved for transplant ineligible patients. The combination of daratumumab with bortezomib, thalidomide and dexamethasone was approved for transplant eligible patients. These combinations are expected to improve the survival outlook for patients with multiple myeloma, without an unacceptable risk of increase in adverse events and updated information on PFS and OS is expected from the above trials.",2020,The stringent Complete Response (sCR) rate at Day 100 post-transplant in the daratumumab group was 29% compared with 20% in the control group [odds ratio (OR):,"['patients with multiple myeloma', 'autologous stem cell transplant', 'adult patients newly diagnosed with multiple myeloma', 'transplant eligible patients', 'newly diagnosed Multiple Myeloma (MM', 'transplant ineligible patients']","['bortezomib, melphalan', 'lenalidomide and low dose dexamethasone or bortezomib, melphalan and prednisone', 'dexamethasone', 'bortezomib, thalidomide and dexamethasone', 'daratumumab (Darzalex', 'bortezomib, melphalan and prednisone']","['stringent Complete Response (sCR) rate', 'rate of neutropenia and infections', 'Overall adverse events', 'survival outlook', 'PFS', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C4058940', 'cui_str': 'Darzalex'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.105223,The stringent Complete Response (sCR) rate at Day 100 post-transplant in the daratumumab group was 29% compared with 20% in the control group [odds ratio (OR):,"[{'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Michaleas', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Penninga', 'Affiliation': 'Danish Medicines Agency Copenhagen, Denmark.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Hovgaard', 'Affiliation': 'Danish Medicines Agency Copenhagen, Denmark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dalseg', 'Affiliation': 'Danish Medicines Agency Copenhagen, Denmark.'}, {'ForeName': 'Aldana', 'Initials': 'A', 'LastName': 'Rosso', 'Affiliation': 'Danish Medicines Agency Copenhagen, Denmark.'}, {'ForeName': 'Sinan B', 'Initials': 'SB', 'LastName': 'Sarac', 'Affiliation': 'Danish Medicines Agency Copenhagen, Denmark.'}, {'ForeName': 'Jorge Camarero', 'Initials': 'JC', 'LastName': 'Jimenez', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Lucia López-Anglada', 'Initials': 'LL', 'LastName': 'Fernández', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Carolina Prieto', 'Initials': 'CP', 'LastName': 'Fernández', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mangas-SanJuan', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garcia', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Payares-Herrera', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Aranzazu', 'Initials': 'A', 'LastName': 'Sancho-López', 'Affiliation': 'Instituto de Investigación Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.'}, {'ForeName': 'Marcia Sofia Sanches de Castro Lopes', 'Initials': 'MSSCL', 'LastName': 'Silva', 'Affiliation': 'INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Duarte', 'Affiliation': 'INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1002/onco.13554']
2641,33026710,Cumulative Disadvantage and Disparities in Depression and Pain among Veterans with Osteoarthritis: The Role of Perceived Discrimination.,"OBJECTIVE


Perceived discrimination is associated with chronic pain and depression and contributes to racial health disparities. In a cohort of older adult veterans with osteoarthritis (OA), we sought to examine how membership in multiple socially disadvantaged groups (cumulative disadvantage) was associated with perceived discrimination, pain, and depression. We also tested whether perceived discrimination mediated the association of cumulative disadvantage with depression and pain.
METHODS


We analyzed baseline data from 270 African American and 247 White veterans enrolled in a randomized controlled trial testing a psychological intervention for chronic pain at two VA medical centers. Participants were aged ≥50 years and self-reported symptomatic knee OA. Measures included the Everyday Discrimination Scale, Patient Health Questionnaire Depression Scale (PHQ-8), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and demographic variables. Cumulative disadvantage was defined as the number of socially disadvantaged groups to which each participant belonged (i.e., self-reported female gender, African American race, income<$20,000, and/or unemployed due to disability). We used linear regression models and Sobel's test of mediation to examine hypotheses.
RESULTS


The average number of social disadvantages was 1.3 (SD=1.0). Cumulative disadvantage was significantly associated with higher perceived discrimination, pain, and depression (p's<.001). Perceived discrimination significantly mediated the association between cumulative disadvantage and depression symptoms (Z=3.75, p<.001) as well as pain severity (Z=2.24, p=.025).
CONCLUSION


Perceived discrimination is an important psychosocial stressor that contributes to poor OA-related mental and physical health outcomes, with greater effects among those from multiple socially disadvantaged groups.",2020,"Cumulative disadvantage was significantly associated with higher perceived discrimination, pain, and depression (p's<.001).","['older adult veterans with osteoarthritis (OA', '270 African American and 247 White veterans enrolled', 'Participants were aged ≥50 years and self-reported symptomatic knee OA', 'Veterans with Osteoarthritis']",['psychological intervention'],"['Everyday Discrimination Scale, Patient Health Questionnaire Depression Scale (PHQ-8), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and demographic variables', 'discrimination, pain, and depression', 'Cumulative Disadvantage and Disparities in Depression and Pain', 'Cumulative disadvantage', 'average number of social disadvantages', 'pain severity', 'cumulative disadvantage and depression symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",270.0,0.0345058,"Cumulative disadvantage was significantly associated with higher perceived discrimination, pain, and depression (p's<.001).","[{'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'McClendon', 'Affiliation': ""National Center for PTSD (116B-3), Women's Health Sciences Division, VA Boston Healthcare System, 150 S. Huntington Avenue, Boston, Massachusetts, USA.""}, {'ForeName': 'Utibe R', 'Initials': 'UR', 'LastName': 'Essien', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, Center for Health Equity Research and Promotion, Pittsburgh, PA, USA.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Youk', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, Center for Health Equity Research and Promotion, Pittsburgh, PA, USA.'}, {'ForeName': 'Said A', 'Initials': 'SA', 'LastName': 'Ibrahim', 'Affiliation': 'Corporal Michael J. Crescenz Veterans Affairs Medical Center, Center for Health Equity Research and Promotion, Philadelphia, PA, USA.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Vina', 'Affiliation': 'University of Arizona, College of Medicine, University of Arizona Arthritis Center, Tucson, AZ, USA.'}, {'ForeName': 'C Kent', 'Initials': 'CK', 'LastName': 'Kwoh', 'Affiliation': 'University of Arizona, College of Medicine, University of Arizona Arthritis Center, Tucson, AZ, USA.'}, {'ForeName': 'Leslie R M', 'Initials': 'LRM', 'LastName': 'Hausmann', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, Center for Health Equity Research and Promotion, Pittsburgh, PA, USA.'}]",Arthritis care & research,['10.1002/acr.24481']
2642,33026719,Evaluation of Gingival Displacement with Aluminum Chloride and Naphazoline Hydrochloride: A Randomized Controlled Trial.,"The objective of this study was to evaluate the use of naphazoline hydrochloride in comparison with aluminum chloride for vertical gingival displacement. The inclusion criteria were: patients with a good general systemic condition; periodontal health; and thick gingival biotype. Moreover, the exclusion criteria were: smoking individuals; canine teeth or central incisors with carious lesions, abrasion, erosion, prosthetic abutments or unsatisfactory restorations; patients with periodontal disease; and users of continuous medication. 72 teeth were included and the Square Block Design was used to randomize the samples. Three measures were obtained from each tooth, and mean vertical gingival displacement was calculated. A descriptive analysis of the average displacement was performed. The normality test used was the Lilliefors' Test and for comparison between treatments, the Kruskal-Wallis Test was used. The Bartlett's Test for homogeneity of variances was used and a 5% (p ⟨ 0.05) significant level was considered. Thus, the Aluminum Chloride and Naphazoline Hydrochloride showed no statistically amount of gingival retraction than the control group (p = 0.3822). The average of gingival vertical displacement in all groups were less than 0,5 mm. The technique used did not allow any amount of horizontal displacement on obtained models.",2020,"Thus, the Aluminum Chloride and Naphazoline Hydrochloride showed no statistically amount of gingival retraction than the control group (p = 0.3822).","['The inclusion criteria were: patients with a good general systemic condition; periodontal health; and thick gingival biotype', '72 teeth', 'exclusion criteria were: smoking individuals; canine teeth or central incisors with carious lesions, abrasion, erosion, prosthetic abutments or unsatisfactory restorations; patients with periodontal disease; and users of continuous medication']","['Aluminum Chloride and Naphazoline Hydrochloride', 'naphazoline hydrochloride', 'aluminum chloride']","['mean vertical gingival displacement', 'average of gingival vertical displacement', 'gingival retraction']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441707', 'cui_str': 'Biotyping'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0282259', 'cui_str': 'Naphazoline hydrochloride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",72.0,0.0278638,"Thus, the Aluminum Chloride and Naphazoline Hydrochloride showed no statistically amount of gingival retraction than the control group (p = 0.3822).","[{'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'de Carvalho', 'Affiliation': 'State University of Maringa.'}, {'ForeName': 'L C V', 'Initials': 'LCV', 'LastName': 'Junior', 'Affiliation': 'State University of Maringa.'}, {'ForeName': 'H F B', 'Initials': 'HFB', 'LastName': 'Junior', 'Affiliation': 'State University of Maringa.'}, {'ForeName': 'T P D S', 'Initials': 'TPDS', 'LastName': 'Suguiura', 'Affiliation': 'State University of Maringa.'}, {'ForeName': 'I T S', 'Initials': 'ITS', 'LastName': 'Previdelli', 'Affiliation': 'State University of Maringa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sábio', 'Affiliation': 'State University of Maringa.'}]",The European journal of prosthodontics and restorative dentistry,['10.1922/EJPRD_2066Junior10']
2643,33017662,Clinical Outcomes in Patients With FLT3-ITD-Mutated Relapsed/Refractory Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplant After Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial.,"Despite the substantial clinical activity of fms-related tyrosine kinase 3 (FLT3) inhibitors in relapsed or refractory (R/R) FLT3-ITD‒positive acute myeloid leukemia (AML), durable remissions and prolonged survival in this population require allogeneic hematopoietic stem cell transplant (allo-HSCT). Quizartinib, a once-daily, oral, highly potent and selective FLT3 inhibitor, significantly prolonged overall survival (OS) and improved clinical benefit compared with salvage chemotherapy (median OS, 6.2 vs 4.7 months; hazard ratio [HR], 0.76 [95% CI, 0.58-0.98]; P = 0.018; composite complete remission [CRc] rate, 48% vs 27%; median duration of CRc, 2.8 vs 1.2 months; mortality rates, 0.8% vs 14% [by day 30], 7% vs 24% [by day 60]) in patients with R/R FLT3-ITD AML in the phase 3 QuANTUM-R trial. In this post hoc analysis, we described the characteristics of and clinical outcomes in patients who underwent an on-study HSCT in QuANTUM-R per investigator discretion and institutional practices. Of 367 randomized patients, 78 (32%) in the quizartinib arm and 14 (11%) in the salvage chemotherapy arm underwent an on-study allo-HSCT without any intervening therapy for AML after quizartinib or study-specified salvage chemotherapy. Pooled data of patients from both treatment arms showed a longer median OS in transplanted patients vs those treated without a transplant (12.2 vs 4.4 months; HR, 0.315 [95% CI, 0.233-0.427]). Pooled data also showed a longer median OS in patients with a last recorded response of CRc before allo-HSCT vs patients without a CRc (20.1 vs 8.8 months; HR, 0.506 [95% CI, 0.296-0.864]). By treatment arm, the median OS was 25.1 months with quizartinib and 20.1 months with salvage chemotherapy in patients with a last recorded response of CRc prior to allo-HSCT. Forty-eight patients in the quizartinib arm continued quizartinib treatment after allo-HSCT. In the 31 patients with a last recorded response of CRc prior to allo-HSCT who continued quizartinib after allo-HSCT, median OS was 27.1 months. Continuation of quizartinib after allo-HSCT was tolerable and no new safety signals were identified. These results suggest that post-transplant survival following salvage chemotherapy and quizartinib treatment are similar. However, quizartinib response occurs more frequently than with salvage chemotherapy, potentially allowing more patients to undergo transplant and achieve durable clinical benefit. Additionally, post-HSCT quizartinib was found to be tolerable and may be associated with prolonged survival in some patients, highlighting its potential value in the management of patients with FLT3-ITD R/R AML.",2020,"Pooled data of patients from both treatment arms showed a longer median OS in transplanted patients vs those treated without a transplant (12.2 vs 4.4 months; HR, 0.315","['Patients With FLT3-ITD-Mutated Relapsed/Refractory Acute Myeloid Leukemia', 'Undergoing Hematopoietic Stem Cell Transplant', 'Forty-eight patients in the quizartinib arm continued quizartinib treatment after allo-HSCT', '367 randomized patients, 78 (32%) in the quizartinib arm and 14 (11%) in the salvage chemotherapy arm underwent an on-study allo', 'patients who underwent an on-study HSCT in QuANTUM-R per investigator discretion and institutional practices']","['HSCT without any intervening therapy for AML after quizartinib or study-specified salvage chemotherapy', 'Quizartinib or Salvage Chemotherapy', 'salvage chemotherapy']","['median duration of CRc', 'overall survival (OS', 'longer median OS', 'mortality rates', 'quizartinib response', 'response of CRc', 'median OS', 'prolonged survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1570097', 'cui_str': 'FER protein, human'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4528668', 'cui_str': 'Acute myeloid leukaemia refractory'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0021626', 'cui_str': 'Institutional Practice'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2980091', 'cui_str': 'quizartinib'}]",367.0,0.0468284,"Pooled data of patients from both treatment arms showed a longer median OS in transplanted patients vs those treated without a transplant (12.2 vs 4.4 months; HR, 0.315","[{'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'The University of Kansas Health System, Kansas City, KS. Electronic address: sganguly@kumc.edu.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Universität Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Perl', 'Affiliation': 'Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Russell', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Arunachalam', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Cedric Dos', 'Initials': 'CD', 'LastName': 'Santos', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gammon', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Lesegretain', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Derek E', 'Initials': 'DE', 'LastName': 'Mires', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ.'}, {'ForeName': 'Samer K', 'Initials': 'SK', 'LastName': 'Khaled', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.09.036']
2644,33017685,Retrograde bladder filling after laparoscopic gynecologic surgery: a double-blind randomized controlled trial.,"OBJECTIVE


To evaluate whether retrofilling the bladder upon completion of elective laparoscopic gynecologic surgery for benign indications has an effect on the timing of the first post-operative void and timing of discharge from hospital.
DESIGN


Double-blind randomized controlled trial SETTING: Single academic surgical day hospital PATIENTS: Patients undergoing outpatient laparoscopic gynecologic surgery, excluding hysterectomy or pelvic reconstructive surgery.
INTERVENTIONS


Upon completion of surgery, patients were randomized to either retrograde filling of the bladder with 200 mL of saline prior to catheter removal or standard care (immediate catheter removal). Patients and PACU nurses (outcome assessors) were both blinded.
MEASUREMENTS


The primary outcome was the time to first void. Secondary outcomes were time to hospital discharge, post-operative urinary tract infection and patient satisfaction.
MAIN RESULTS


Over a 3 month period, 47 patients were approached on the day of surgery, 42 consented and were randomized (21 to intervention and 21 to control). There were no significant differences in baseline demographics between groups. The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001). Retrofilled patients were discharged faster from PACU compared to controls (155.0 ± 74min vs 227 ± 58min, p=0.001). There were no urinary tract infections in either group and the proportion of satisfied or very satisfied patients was high (93.8% vs. 88.2%, p=0.512).
CONCLUSION


Retrograde filling the bladder after outpatient laparoscopic gynecologic surgery is a safe, effective method that significantly reduces length of hospital stay.",2020,"The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001).","['Patients undergoing outpatient laparoscopic gynecologic surgery, excluding hysterectomy or pelvic reconstructive surgery', '47 patients were approached on the day of surgery, 42 consented']","['elective laparoscopic gynecologic surgery', 'retrograde filling of the bladder with 200 mL of saline prior to catheter removal or standard care (immediate catheter removal', 'Retrograde bladder filling after laparoscopic gynecologic surgery']","['time to first void', 'median time to first void', 'urinary tract infections', 'length of hospital stay', 'time to hospital discharge, post-operative urinary tract infection and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",47.0,0.474424,"The median time to first void was significantly shorter for patients in the intervention arm compared to controls (104 ± 75min vs 162 ± 76min, p<0.001).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Zakhari', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2; McGill University Health Center (MUHC) - Glen Site, 1001 boulevard Décarie, Montreal QC, Canada, H4A 3JI.'}, {'ForeName': 'Wusun', 'Initials': 'W', 'LastName': 'Paek', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Darl', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'Biostatistics Research Unit, University Health Network (UHN), 200 Elizabeth Street, Toronto ON, Canada, M5G 2C4.'}, {'ForeName': 'M Jonathon', 'Initials': 'MJ', 'LastName': 'Solnik', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Murji', 'Affiliation': 'Mount Sinai Hospital, Department of Obstetrics and Gynecology, 600 University Avenue, Toronto ON, Canada, M5G 1\u202f×\u202f5; University of Toronto, Department of Obstetrics & Gynecology, 123 Edwards Street, Toronto, Ontario, Canada, M5G 1E2. Electronic address: ally.murji@sinaihealthsystem.ca.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.09.019']
2645,33017755,Admission Blood Pressure and Outcome of Endovascular Therapy: Secondary Analysis of ASTER Trial.,"BACKGROUND


Elevated blood pressure (BP) is common among patients presenting with acute ischemic stroke due to large vessel occlusions. The literature is inconsistent regarding the association between admission BP and outcome of mechanical thrombectomy (MT). Moreover, it is unclear whether the first line thrombectomy strategy (stent retriever [SR] versus contact aspiration [CA]) modifies the relationship between BP and outcome.
METHODS


This is a post hoc analysis of the ASTER (Contact Aspiration Versus Stent Retriever for Successful Revascularization) randomized trial. BP was measured prior to randomization in all included patients. Co-primary outcomes included 90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia [mTICI] 2b-3). Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH) within 24 hours.
RESULTS


A total of 381 patients were included in the present study. Mean (SD) systolic BP (SBP) and diastolic BP (DBP) were 148 (26) mm Hg and 81 (16) mm Hg, respectively. There was no association between SBP or DBP and successful revascularization or 90-day functional independence. Similarly, there was no association between admission SBP or DBP with sICH or PH. Subgroup analysis based on the first-line thrombectomy strategy revealed similar results with no heterogeneity across groups.
CONCLUSION


Admission BP was not associated with functional, angiographic or safety outcomes. Results were similar in both CA and CA groups.",2020,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"['patients presenting with acute ischemic stroke due to large vessel occlusions', 'A total of 381 patients were included in the present study']",['contact aspiration [CA'],"['Mean (SD) systolic BP (SBP) and diastolic BP (DBP', 'symptomatic intracerebral hemorrhage (sICH) and parenchymal hemorrhage (PH', 'SBP or DBP and successful revascularization or 90-day functional independence', '90-day functional independence (modified Rankin Scale [mRS] 0-2) and successful revascularization (modified Treatment in Cerebral Ischemia', 'Admission BP', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",381.0,0.0769627,There was no association between SBP or DBP and successful revascularization or 90-day functional independence.,"[{'ForeName': 'Mohnammd', 'Initials': 'M', 'LastName': 'Anadani', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, United States. Electronic address: manadani@wustl.edu.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center, Foch Hospital, Suresnes, France. Electronic address: bertrand.lapergue@gmail.com.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: rblanc29@gmail.com.'}, {'ForeName': 'Maéva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: maeva.kyheng@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: julien.labreuche.chru@gmail.com.'}, {'ForeName': 'Malek Ben', 'Initials': 'MB', 'LastName': 'Machaa', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mbenmaacha@for.paris.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Department of Biostatistics, University Lille, CHU Lille, EA 2694-Santé Publique: Epidémiologie et Qualité des Soins, France. Electronic address: alain.duhamel59@gmail.com.'}, {'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, France. Electronic address: gaultier.marnat@chu-bordeaux.fr.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Saleme', 'Affiliation': 'Department of Interventional Neuroradiology, University Hospital of Limoges, France. Electronic address: suzanna.saleme@chu-limoges.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France. Electronic address: vincentcost@hotmail.com.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: s.bracard@chru-nancy.fr.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: r.anxionnat@gmail.com.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Spiotta', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, United States. Electronic address: spiotta@musc.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'DeHavenon', 'Affiliation': 'Department of Neurology, Utah University, Salt lake, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Stroke Unit, University Hospital of Nancy, Université de Lorraine, INSERM U1116, Nancy, France. Electronic address: s.richard@chru-nancy.fr.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Department of Neuroradiology, Guillaume et René Laennec University Hospital, Nantes, France. Electronic address: hubert.desal@chu-nantes.fr.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mmazighi@for.paris.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Neuroradiology, Foch Hospital, Suresnes, France. Electronic address: a.consoli@hopital-foch.com.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. Electronic address: mpiotin@for.paris.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy, Université de Lorraine, INSERM U1254, Nancy, France. Electronic address: benjagory@gmail.com.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105347']
2646,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE


Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN


Double-blinded randomized placebo-controlled trial.
SETTING


Labor and delivery triage room.
PATIENTS


Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS


Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS


The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS


Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95%  = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95%  = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95%  = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95%  = -4.93, -0.34]; P = 0.025).
CONCLUSION


Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
2647,33017854,Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.,"INTRODUCTION


The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety.
METHODS


MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an ""as received"" basis during week 0-52. Electrocardiogram data were recorded at baseline and week 24.
RESULTS


Comparing 205 patients who received ≥1 dose of MPH with 209 patients who received PLAC, AEs occurring significantly more frequently in the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs. 4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs. 2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs. 1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes occurred very rarely in both groups. Serious AEs were rare and without a significant group difference. The comparison of 206 patients treated with GPT versus 209 patients who received CM revealed no major differences. Serious AE classified as psychiatric occurred in 5 cases in the CM group and in 1 case in the GPT group.
CONCLUSION


In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.",2020,Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%).,"['206 patients treated with GPT versus 209 patients who received', 'Adult ADHD Patients - Results of the COMPAS Study']","['cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM', 'Methylphenidate and Psychotherapy', 'PLAC', 'CM', 'Methylphenidate', 'methylphenidate (MPH) with placebo (PLAC', 'methylphenidate']","['dry mouth', 'gastrointestinal infection', 'acute tonsillitis', 'hyperhidrosis, tachycardia, weight decrease', 'palpitations', 'depressive symptom, influenza', 'Syncope', 'safe and well-tolerated', 'agitation', 'decreased appetite', 'ECG changes', 'adverse events (AEs', 'Electrocardiogram data', 'restlessness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0729555', 'cui_str': 'Infection of digestive system'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",433.0,0.144004,Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%).,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kis', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, St. Elisabeth Hospital Niederwenigern, Contilia Group, Hattingen, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lücke', 'Affiliation': 'Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Abdel-Hamid', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Heßmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center, Göttingen, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Clinical Trials Unit and Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Borel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Clinical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rösler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huss', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medicine Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'University Hospital of Würzburg, Center of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Würzburg, Germany.'}, {'ForeName': 'Ludger Tebartz', 'Initials': 'LT', 'LastName': 'van Elst', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Helge H O', 'Initials': 'HHO', 'LastName': 'Müller', 'Affiliation': 'Witten/Herdecke University, Faculty of Health/School of Medicine, Integrative Psychiatry and Psychotherapy, Witten, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy - University of Bonn, Bonn, Germany.'}]",Pharmacopsychiatry,['10.1055/a-1207-9851']
2648,33017886,Changes in body mass index in boys with central precocious puberty over 2 years of gonadotropin-releasing hormone agonist therapy.,"PURPOSE


Gonadotropin-releasing hormone agonist (GnRHa) is a safe and effective therapy used to treat central precocious puberty (CPP). Although most studies have reported no significant difference in body mass index (BMI) in girls during and after GnRHa therapy, few studies have investigated changes in BMI in boys with CPP. This study evaluated the effects of GnRHa therapy on BMI in boys with CPP.
METHODS


This study included 75 boys with CPP at Ajou University Hospital between January 1, 2007 and December 31, 2016, who treated with leuprorelin acetate or triptorelin acetate every 4 weeks for at least 2 years. The subjects were divided into 3 groups according to BMI: normal weight, overweight, and obese. We analyzed the BMI standard deviation score (SDS) in each group before therapy and after 1 year and 2 years of therapy.
RESULTS


Of the 75 boys, 37 were in the normal weight group, 21 were in the overweight group, and 17 were in the obese group. Magnetic resonance imaging that was performed before treatment showed abnormal findings in 9 boys. The mean BMI SDS for all participants at initiation was 1.0±0.8, and that in the normal weight, overweight, and obese groups was 0.3±0.4, 1.3±0.1, and 1.9±0.3, respectively. There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
CONCLUSION


The BMI SDS in boys with CPP did not significantly change over 2 years of GnRHa therapy.",2020,"There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
","[' 37 were in the normal weight group, 21 were in the overweight group, and 17 were in the obese group', 'boys with central precocious puberty over 2 years of', 'every 4 weeks for at least 2 years', '75 boys with CPP at Ajou University Hospital between January 1, 2007 and December 31, 2016, who treated with', '75 boys', 'boys with CPP']","['leuprorelin acetate or triptorelin acetate', 'Gonadotropin-releasing hormone agonist (GnRHa', 'Magnetic resonance imaging', 'gonadotropin-releasing hormone agonist therapy', 'GnRHa therapy']","['body mass index', 'body mass index (BMI', 'BMI SDS', 'BMI standard deviation score (SDS', 'mean BMI SDS']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0700596', 'cui_str': 'Leuprolide acetate'}, {'cui': 'C0771825', 'cui_str': 'Triptorelin acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",75.0,0.0184315,"There were no significant differences in BMI SDS in any group after 1 or 2 years of treatment.
","[{'ForeName': 'Kyung In', 'Initials': 'KI', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Hae Sang', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Depar tment of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jin Soon', 'Initials': 'JS', 'LastName': 'Hwang', 'Affiliation': 'Depar tment of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.'}]",Annals of pediatric endocrinology & metabolism,['10.6065/apem.1938176.088']
2649,33018052,Closed-loop Electroencephalogram-based modulated audio to fall and deepen sleep faster.,"The transition from wake to sleep is a continuum that is well characterized by the electroencephalogram (EEG) power spectral ratio (ρ) between the beta (15 to 30 Hz) and theta (4 to 8 Hz) bands. From wake to sleep, the value of ρ gradually decreases.We have designed and implemented a single EEG-signal based closed-loop system that leverages ρ to modulate the volume of a pink-noise type of audio such that the volume becomes gradually softer as sleep initiates. A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.",2020,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,[],['Closed-loop Electroencephalogram-based modulated audio'],['sleep latency and latency to deep sleep'],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.0164796,A proof-of-concept trial was conducted with this system and it was found that using this concept resulted in a reduction of sleep latency and latency to deep sleep.,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Garcia-Molina', 'Affiliation': ''}, {'ForeName': 'Boomika', 'Initials': 'B', 'LastName': 'Kalyan', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Aquino', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175689']
2650,33018086,Sex Differences in Heart Rate Nonlinearity by Multifractal Multiscale Detrended Fluctuation Analysis.,"Recent developments of detrended fluctuation analysis (DFA) provide multifractal/multiscale (MFMS) descriptions of the heart rate self-similarity, a promising approach to cardiovascular complexity. However, it is unclear whether the MFMS DFA may also describe the nonlinear components of heart rate variability. Our aim is to define MFMS DFA indices for quantifying the short-term and long-term degree of the heart-rate nonlinearity and to apply these indices to detect possible sex-related differences.We recorded the inter-beat-interval (IBI) series in 42 male and in 42 female healthy participants sitting at rest for about 2 hours. For each series j, we generated 100 phase-randomized surrogate series. We applied the MFMS DFA to estimate the self-similarity coefficients α over scales τ between 8 and 512 s and moment orders q between -5 and +5, obtaining coefficients for the original series, α O,j  (q, τ), and for each surrogate, α i,j  (q, τ) with 1≤i≤100. We first evaluated π j (q, τ), percentile of α i,j  (q, τ) distribution in which was α O,j  (q, τ). Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)). We found that NL 1 (q) was generally greater than 50% at all q≥0 but q=2 (i.e., moment order of the monofractal DFA), while at q<0 it was high in males only, with significant sex differences at q=-1 and q=-2. Results indicate that the multifractal DFA may highlight nonlinear heart-rate components at the short scales that are not revealed by the traditional monofractal DFA and that appear related to gender differences.Clinical Relevance- This supports the use of MFMS DFA to integrate the linear information from traditional spectral methods of heart rate variability in clinical studies aimed at improving the stratification of the cardiovascular risk.",2020,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).",['42 male and in 42 female healthy participants sitting at rest for about 2 hours'],"['Clinical Relevance', 'MFMS DFA']","['π j (q, τ), percentile of α i,j  (q, τ) distribution']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",42.0,0.0275659,"Then we calculated the percentages of scales where π j (q, τ) was <5% for 8≤τ≤16 s (short-term nonlinearity index NL 1 (q)) and for 16≤τ≤512 s (long-term nonlinearity index NL 2 (q)).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Castiglioni', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lazzeroni', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Coruzzi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Faini', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176704']
2651,33018534,Modulatory Effects of Respiratory-Gated Auricular Vagal Nerve Stimulation on Cardiovagal Activity in Hypertension .,"The objective of this study was to determine potential effects of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on cardiac autonomic activity in hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males) were randomized to receive either active RAVANS at 25 Hz or sham stimulation for 5 consecutive days and were assessed 5 and 10 days later. Continuous electrocardiogram, pulse rate, and blood pressure signals were collected during 10-minute baseline, 30-minute stimulation, and 10-minute recovery periods for each session. LabChart was used to acquire and process heart rate variability and blood pressure indices. Percent changes of mean values during the recovery period were calculated comparing the final stimulation session and follow-up sessions to the first stimulation session. General linear models were applied to assess the effects of RAVANS on the variables evaluated, considering baseline values and sex as covariates in the models.We found that RAVANS increased high frequency (HF-HRV) power during recovery of the final stimulation session and both follow-up sessions in comparison to sham. RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation. No significant effects on blood pressure values were observed during these periods.These results suggest that RAVANS effectively stimulates cardiovagal activity in hypertension, with effects lasting up to 10 days. Future research incorporating larger sample sizes is needed to replicate the effects of RAVANS.Clinical Relevance- This research has implications for potential therapeutic effects of respiratory-gated tVNS on cardiovagal modulation in hypertensive patients.",2020,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"['hypertensive patients.20 hypertensive subjects (57.3±6.2 years; 11 females, 9 males', 'Hypertension ', 'hypertensive patients']","['Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS', 'Respiratory-Gated Auricular Vagal Nerve Stimulation', 'active RAVANS at 25 Hz or sham stimulation', 'respiratory-gated tVNS', 'RAVANS.Clinical Relevance']","['cardiac autonomic activity', 'heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD', 'Cardiovagal Activity', 'blood pressure values', 'high frequency (HF-HRV', 'Continuous electrocardiogram, pulse rate, and blood pressure signals']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0199562', 'cui_str': 'Continuous electrocardiogram'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0436104,RAVANS also lowered heart rate and increased average RR and root mean square of successive RR interval differences (RMSSD) during recovery on the final day of stimulation.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Staley', 'Affiliation': ''}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Garcia', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stowell', 'Affiliation': ''}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Sclocco', 'Affiliation': ''}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ''}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barbieri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175768']
2652,33019274,Can not touching the nose or eyes help cold prevention? Possibility of application using a smartwatch and self-checking.,"More than 200 virus strains have been implicated in common colds, thereby thwarting vaccination efforts. However, the most common causes of colds are human rhinoviruses, which infect the epithelial cells of the nasopharynx. Moreover, after decades of research, the best documented method of preventing infection remains to be handwashing. However, stopping people from inadvertently touching or rubbing one's nose and eyes is difficult, and the effectiveness of preventing such habits has not been validated. Here, we reported the results of a randomized controlled trial (n = 120) performed over 50 days. We examined the effectiveness of using smartwatches equipped with a sensor and a vibration alert, as well as the self-checking of behavior, in preventing subjects from touching their nose or eyes. Participants were randomly assigned to either the smartwatch group or the handwashing group (control). Subjects in the handwashing group were requested to wash their hands after going out, whereas subjects in the smartwatch group were requested to wash their hands and in addition wear a smartwatch that vibrates to remind them not to excessively touch their nose or eyes. The daily frequency of nose and eye touching was also recorded by the smartwatches. The first incidence of an upper respiratory tract infection (URTI) was the primary endpoint. In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).",2020,"In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).",[],"['smartwatch group or the handwashing group (control', 'smartwatch group were requested to wash their hands and in addition wear a smartwatch that vibrates to remind them not to excessively touch their nose or eyes']","['incidence of URTIs', 'upper respiratory tract infection (URTI', 'mean frequency of nose or eye touching', 'daily frequency of nose and eye touching']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.026638,"In the smartwatch group, compared with the control group, the incidence of URTIs was significantly lower by 53% (p < 0.05) and was associated with a decrease in the mean frequency of nose or eye touching (p < 0.05).","[{'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9176589']
2653,33019332,Comparison of Three Normalization Methods in Monitoring Analgesic Depth with Photoplethysmographic Diastolic Interval.,"The purpose of the present study was to investigate the ability of three different normalization methods, namely root mean square (RMS) value, mean value, and maximum which referred to pulse beat interval (PBI), based on photoplethysmographic diastolic interval (DI) in response to laryngeal mask airway (LMA) insertion under various remifentanil concentrations during general anesthesia. Sixty patients were randomly allocated to one of the four groups to receive a possible remifentanil effect-compartment target concentration (Ce remi ) of 0, 1, 3, or 5 ng/ml, and an effect-compartment target controlled infusion of propofol to maintain the state entropy (SE) at 40~60. Three normalized measures DI RMS , DI Mean , and DIPBI were compared with the DI values without normalization. Before LMA insertion, only DI showed a considerable correlation with remifentanil concentrations. DI RMS  and DI Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml). DIRMS was superior to all other variables in grading analgesic depth after nociceptive event occurred with PK value of 0.836. These results demonstrate that the normalization using RMS value, compared to using mean value and maximum, seems to provide a more effective approach for signal pre-processing.",2020,Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml).,"['Sixty patients', 'general anesthesia']","['remifentanil effect-compartment target concentration (Ce remi ) of 0, 1, 3, or 5 ng/ml, and an effect-compartment target controlled infusion of propofol to maintain the state entropy (SE', 'laryngeal mask airway (LMA) insertion']","['namely root mean square (RMS) value, mean value, and maximum which referred to pulse beat interval (PBI), based on photoplethysmographic diastolic interval (DI', 'DI RMS  and DI', 'normalized measures DI RMS , DI Mean , and DIPBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",60.0,0.0348147,Mean  performed better than DI in discriminating 'insufficient' concentrations (0 and 1 ng/ml) from 'sufficient' concentrations (3 and 5 ng/ml).,"[{'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ''}, {'ForeName': 'Shali', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC44109.2020.9175443']
2654,33019392,Gestational diabetes mellitus in women increased the risk of neonatal infection via inflammation and autophagy in the placenta.,"BACKGROUND


Gestational diabetes mellitus (GDM) produces numerous problems for maternal and fetal outcomes. However, the precise molecular mechanisms of GDM are not clear.
METHODS


In our study, we randomly assigned 22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China. Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α) were measured from blood plasma of pregnant women and umbilical arteries using ultraviolet spectrophotometry. Hematoxylin & Eosin (H&E), Periodic acid-Schiff (PAS) or Masson staining were performed to examine whether diabetes mellitus altered the morphology of placenta. Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining were performed to examine whether diabetes mellitus and autophagy altered the gene expressions of the placental tissue.
RESULTS


We found that women with GDM exhibited increased placental weight and risk of neonatal infection. The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood. H&E, Masson and PAS staining results showed an increased number of placental villi and glycogen deposition in patients with GDM, but no placental sclerosis was found. Q-PCR results suggested that the expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway were increased in the GDM placenta. Through Western Blotting, we found that the expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta was significantly enhanced. We also showed that the key autophagy-related genes, autophagy-related 7 (ATG7) and microtubule-associated protein 1A/1B-light chain 3 (LC3), were increased in GDM compared with normal pregnant women.
CONCLUSIONS


Our results suggest that women with GDM exhibit an increased risk of neonatal infection via inflammation and autophagy in the placenta.",2020,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"['women with GDM', 'Gestational diabetes mellitus (GDM', '22 pregnant women with fasting glucose concentrations, 1 hour oral glucose tolerance test (1H-OGTT) and 2 hour oral glucose tolerance test (2H-OGTT), different than 28 normal pregnant women from a sample of 107 pregnant women at the First Affiliated Hospital of Jinan University in China']","['Periodic acid-Schiff (PAS) or Masson staining', 'Hematoxylin & Eosin']","['concentrations of IL-6 protein and IL-8 protein in GDM', 'risk of neonatal infection via inflammation and autophagy', 'Quantitative PCR (Q-PCR), western blotting and immunofluorescent staining', 'expression of NF-kappa-B inhibitor alpha (IKBα) and Nuclear factor-κB p65 (NF-κB p65) in GDM placenta', 'Gestational diabetes mellitus', 'expression levels of HIF-1α and the toll like receptor 4 (TLR4)/ myeloid differential protein-88 (MyD88)/ nuclear factor kappa-B (NF-κB) pathway', 'number of placental villi and glycogen deposition', 'Lipopolysaccharide (LPS), interleukin 1 alpha (IL-1α), interleukin-6 (IL-6), interleukin-8 (IL-8) and tumor necrosis factor alpha (TNF-α', 'placental weight and risk of neonatal infection', 'placental sclerosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0440048', 'cui_str': 'Periodic acid Schiff stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0018964', 'cui_str': 'Hematoxylin stain'}, {'cui': 'C0014448', 'cui_str': 'Eosine Yellowish'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0854706', 'cui_str': 'Neonatal infection'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0183489', 'cui_str': 'Immunofluorescent stain'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2002434', 'cui_str': 'NFKBIA protein, human'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008508', 'cui_str': 'Chorionic villi structure'}, {'cui': 'C0333566', 'cui_str': 'Glycogen deposition'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0600251', 'cui_str': 'interleukin-1, alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}]",22.0,0.04294,The concentrations of IL-6 protein and IL-8 protein in GDM were increased in both maternal and umbilical arterial blood.,"[{'ForeName': 'Yi-Xiao', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Deng-Lu', 'Initials': 'DL', 'LastName': 'Long', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}, {'ForeName': 'Rui-Man', 'Initials': 'RM', 'LastName': 'Li', 'Affiliation': 'The First Affiliate Hospital of Jinan University.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'International Joint Laboratory for Embryonic Development & Prenatal Medicine, Division of Histology and Embryology, Medical College.'}]",Medicine,['10.1097/MD.0000000000022152']
2655,33019428,Delivery mode-associated gut microbiota in the first 3 months of life in a country with high obesity rates: A descriptive study.,"Delivery methods during childbirth and their related gut microbiota profiles have important impacts on health later in life, they can contribute to the development of diseases such as obesity, whose highest prevalence rate is found among the Mexican child population. Coincidentally, Mexico has one of the highest global average annual rate increase in cesarean births (C-section). Since Mexico leads the world in childhood obesity, studying the relationship between childbirth delivery methods and gut microbiota profiles in this vulnerable population may be used to identify early risk factors for obesity in other developed and developing countries. The objective of this study is to determine the association between child delivery method and gut microbiota profiles in healthy Mexican newborns.Fecal samples of 57 term infants who participated in a randomized clinical trial in 2013 to study the safety of Agave fructans in newborns, were used in this study. DNA samples were extracted and used to characterize the microbiota composition using high-throughput 16S rRNA gene sequencing. The samples were further divided based on childbirth delivery method, as well as early diet. Gut microbiota profiles were determined and analyzed using cluster analysis followed by multiple correspondence analysis.An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method. Feces from infants born by C-section had low levels of Bacteroidetes, high levels of Firmicutes, especially Clostridium and Enterococcus, and a strikingly high ratio of Firmicutes/Bacteroidetes (F:B). Profiles enriched in Bacteroidetes and low F:B ratios, were strongly associated with vaginal delivery.The profile of gut microbiota associated with feces from Mexican infants born by C-section, may be added to the list of boosting factors for the worrying obesity epidemic in Mexico.",2020,"An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method.","['a country with high obesity rates', '57 term infants who participated in a randomized clinical trial in 2013 to study the safety of Agave fructans in newborns', 'healthy Mexican newborns', 'Mexican infants born by C-section']",[],['Gut microbiota profiles'],"[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0331584', 'cui_str': 'Agave'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",[],"[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",57.0,0.0184582,"An unusual high abundance of Proteobacteria was found in the gut microbiota of all Mexican infants studied, regardless of delivery method.","[{'ForeName': 'Chiharu', 'Initials': 'C', 'LastName': 'Murata', 'Affiliation': 'Research Methodology Department. National Institute of Pediatrics, Mexico.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gutiérrez-Castrellón', 'Affiliation': 'General Hospital Dr. Manuel Gea González.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pérez-Villatoro', 'Affiliation': 'Winter Genomics.'}, {'ForeName': 'Itzhel', 'Initials': 'I', 'LastName': 'García-Torres', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Enríquez-Flores', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de la Mora-de la Mora', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fernández-Lainez', 'Affiliation': 'Laboratory of Inborn Errors of Metabolism and Screening, INP, and Postgraduate in Biological Sciences, UNAM, México. Actual Address: Immunoendocrinology, Division of Medical Biology, Department of Pathology and Medical Biology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Werner', 'Affiliation': 'Indigenous Services Canada, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'López-Velázquez', 'Affiliation': 'Group of Research on Biomolecules and Infant Health, IEM&S Lab. INP, México.'}]",Medicine,['10.1097/MD.0000000000022442']
2656,33019676,Feasibility Trial of an eHealth Intervention for Health-Related Quality of Life: Implications for Managing Patients with Chronic Pain during the COVID-19 Pandemic.,"PURPOSE


This study was conducted to determine the feasibility of providing an eHealth intervention for health-related quality of life (HRQOL) to facilitate patient self-management.
METHODS


A randomized controlled trial was conducted from 2019-2020 within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation. Eligible patients included those with chronic low back pain and a SPADE (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) cluster score ≥ 55 based on the relevant scales from the Patient-Reported Outcomes Measurement Information System instrument with 29 items (PROMIS-29). Patients were randomized to the eHealth treatment group, which received a tailored HRQOL report and interpretation guide, or to a wait-list control group. The primary outcome was change in the SPADE cluster score, including its five component scales, over 3 months. Secondary outcomes were changes in low back pain intensity and back-related disability. Treatment effects were measured using the standardized mean difference (SMD) in change scores between groups. The eHealth intervention was also assessed by a survey of the experimental treatment group 1 month following randomization.
RESULTS


A total of 102 patients were randomized, including 52 in the eHealth treatment group and 50 in the wait-list control group, and 100 (98%) completed the trial. A majority of patients agreed that the HRQOL report was easy to understand (86%), provided new information (79%), and took actions to read or learn more about self-management approaches to improve their HRQOL (77%). Although the eHealth intervention met the criteria for a small treatment effect in improving the overall SPADE cluster score (SMD = 0.24;  p = 0.23) and anxiety (SMD = 0.24;  p  = 0.23), and for a small-to-medium treatment effect in improving depression (SMD = 0.37;  p  = 0.06) and back-related disability (SMD = 0.36;  p  = 0.07), none of these results achieved statistical significance because of limited sample size.
CONCLUSION


Given the feasibility of rapid online deployment, low cost, and low risk of adverse events, this eHealth intervention for HRQOL may be useful for patients with chronic pain during the COVID-19 pandemic.",2020,"Although the eHealth intervention met the criteria for a small treatment effect in improving the overall SPADE cluster score (SMD = 0.24;  p = 0.23) and anxiety (SMD = 0.24;  p  = 0.23), and for a small-to-medium treatment effect in improving depression (SMD = 0.37;  ","['2019-2020 within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation', 'Eligible patients included those with chronic low back pain and a SPADE (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) cluster score ≥ 55 based on the relevant scales from the Patient-Reported Outcomes Measurement Information System instrument with 29 items (PROMIS-29', 'A total of 102 patients were randomized, including 52 in the eHealth treatment group and 50 in the wait-list control group, and 100 (98%) completed the trial', 'patients with chronic pain during the COVID-19 pandemic', 'Managing Patients with Chronic Pain during the COVID-19 Pandemic']","['eHealth Intervention', 'eHealth intervention', 'tailored HRQOL report and interpretation guide, or to a wait-list control group']","['SPADE cluster score, including its five component scales', 'back-related disability', 'overall SPADE cluster score', 'health-related quality of life (HRQOL', 'low back pain intensity and back-related disability']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",102.0,0.177012,"Although the eHealth intervention met the criteria for a small treatment effect in improving the overall SPADE cluster score (SMD = 0.24;  p = 0.23) and anxiety (SMD = 0.24;  p  = 0.23), and for a small-to-medium treatment effect in improving depression (SMD = 0.37;  ","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Licciardone', 'Affiliation': 'Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX 76203, USA.'}, {'ForeName': 'Vishruti', 'Initials': 'V', 'LastName': 'Pandya', 'Affiliation': 'Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX 76203, USA.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040381']
2657,33019691,Dislodgement Forces and Cost Effectiveness of Dressings and Securement for Peripheral Intravenous Catheters: A Randomized Controlled Trial.,"OBJECTIVES


Peripheral intravenous catheters (PIVC) are the most frequently used invasive devices in medicine. PIVC failure before treatment completion is a significant concern and occurs in 33-69% of patients. Partial dislodgement and accidental removal are some of the reasons for PIVC failure. The most effective dressing and securement method for preventing accidental removal remains unclear. It was the aim of this study to compare the force required to dislodge a PIVC with four commonly used dressing and securement methods. Additionally, costs were calculated.
METHODS


Truncated 18-gauge i.v. cannulas were attached onto the forearm of 209 volunteers using four different dressings and securements (sterile absorbent wound dressing covered by two different types of elastic polyester fleece, bordered and non-bordered polyurethane). The force during continuously stronger pulling until dislodgement was recorded.
RESULTS


The highest resistance against dislodgement forces could be observed with a sterile absorbent wound dressing covered by two incised elastic polyester fleece dressings. Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
CONCLUSIONS


Elastic polyester fleece secured a PIVC against accidental removal by external force best, compared to commercially-manufactured bordered and non-bordered polyurethane film dressing.",2020,"Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
","['Peripheral Intravenous Catheters', '209 volunteers using four different']","['dressings and securements (sterile absorbent wound dressing covered by two different types of elastic polyester fleece, bordered and non-bordered polyurethane', 'Peripheral intravenous catheters (PIVC', 'Dressings and Securement']",['PIVC failure'],"[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0449485', 'cui_str': 'Type of elastic'}, {'cui': 'C0032474', 'cui_str': 'Polyester'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",209.0,0.0405353,"Commercially-manufactured bordered and non-bordered polyurethan film dressings were 20% to 75% more expensive than sterile absorbent wound dressings covered by elastic polyester fleece dressing.
","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schmutz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Menz', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Heinrich', 'Affiliation': 'Department of Anesthesiology and Critical Care, Medical Center, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9103192']
2658,33019798,"Treatment of Masked Hypertension with a Chinese Herbal Formula: A Randomized, Placebo-Controlled Trial.","Background:  Masked hypertension is associated with adverse cardiovascular outcomes. Nonetheless, no randomized controlled trials exist in the treatment of masked hypertension. The aim of this randomized, placebo-controlled trial was to investigate the efficacy and safety of blood pressure (BP) lowering treatment with a Chinese herbal formula, gastrodia-uncaria granules (GUG), in patients with masked hypertension.  Methods:  Patients with an office BP of <140/90 mmHg and daytime ambulatory BP of 135-150 mmHg systolic and/or 85-95 mmHg diastolic were randomized 1:1 to the treatment of GUG or placebo 5-10 grams twice daily for 4 weeks. The primary efficacy variable was the change in daytime ambulatory BP.  Results:  At baseline, office and daytime BP of the 251 participants (mean age 50.4 years, 53.4% men, mean body mass index 24.5 kg/m 2 , and 2.8%, 1.6%, and 30.7% with cardiovascular disease, diabetes mellitus, and smoking, respectively) averaged 129/82 and 135/89 mmHg, respectively. In the intention-to-treat analysis, daytime systolic/diastolic BP was reduced by 5.44 /3.39 and 2.91/1.60 mmHg in the GUG and placebo groups, respectively. The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mmHg,  P ≤0.025) and 24-h BP (2.33/1.49 mmHg,  P ≤0.012), but not for the clinic and nighttime BPs ( P ≥0.162). The per-protocol analysis in 229 patients produced similar results. Only one adverse event (sleepiness during the day) was reported and no serious adverse event occurred.  Conclusions:  BP lowering treatment with Chinese traditional medicine GUG is efficacious for patients with masked hypertension.  Clinical Trial Registration:  URL: https://www.clinicaltrials.gov. Unique identifier: NCT02156024.",2020,"The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mmHg,  P ≤0.025) and 24-h BP (2.33/1.49 mmHg,  P ≤0.012), but not for the clinic and nighttime BPs","['Patients with an office BP of <140/90 mmHg and daytime ambulatory BP of 135-150 mmHg systolic and/or 85-95 mmHg diastolic', '251 participants (mean age 50.4 years, 53.4% men, mean body mass index 24.5 kg/m 2 , and 2.8%, 1.6%, and 30.7% with cardiovascular disease, diabetes mellitus, and smoking, respectively) averaged 129/82 and 135/89 mmHg, respectively', 'patients with masked hypertension', '229 patients produced similar results']","['GUG or placebo', 'blood pressure (BP) lowering treatment with a Chinese herbal formula, gastrodia-uncaria granules (GUG', 'BP lowering treatment with Chinese traditional medicine', 'placebo', 'GUG', 'Placebo']","['24-h BP', 'daytime systolic/diastolic BP', 'clinic and nighttime BPs', 'adverse event (sleepiness', 'daytime ambulatory BP', 'BP reductions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C3178811', 'cui_str': 'Masked Hypertension'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C1087074', 'cui_str': 'Gastrodia'}, {'cui': 'C1010860', 'cui_str': 'Uncaria'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",251.0,0.600716,"The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mmHg,  P ≤0.025) and 24-h BP (2.33/1.49 mmHg,  P ≤0.012), but not for the clinic and nighttime BPs","[{'ForeName': 'Dong-Yan', 'Initials': 'DY', 'LastName': 'Zhang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi-Bang', 'Initials': 'YB', 'LastName': 'Cheng', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qian-Hui', 'Initials': 'QH', 'LastName': 'Guo', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Shan', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang-Fei', 'Initials': 'FF', 'LastName': 'Wei', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiovascular Diseases, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Sheng', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qi-Fang', 'Initials': 'QF', 'LastName': 'Huang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Hua', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Diseases, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials and Centre for Vascular Evaluations, Shanghai Key Laboratory of Hypertension, National Key Laboratory of Medical Genomics, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046685']
2659,33019807,Ultrasound versus thoracoscopic-guided paravertebral block during thoracotomy.,"BACKGROUND


Paravertebral block can be performed with the aid of surgical landmarks, ultrasound, or a thoracoscope. This study was designed to compare ultrasound-guided paravertebral block with the thoracoscopic technique.
METHODS


This prospective randomized comparative study included 40 adults scheduled for elective thoracic surgery. Study participants were randomized to an ultrasound group or a thoracoscope group. A catheter for paravertebral block was inserted prior to thoracotomy with real-time ultrasound visualization in the ultrasound group, and under thoracoscopic guidance in the thoracoscope group. Total analgesic consumption, visual analogue pain score, technical difficulties, and complications were compared between the 2 groups.
RESULTS


Total analgesic consumption in the first 24 hours was less in the ultrasound group than in the thoracoscope group (rescue intravenous fentanyl 121.25 ± 64.01 µg in the ultrasound group vs. 178.75 ± 91.36 µg in the thoracoscope group;  p  = 0.027). Total paravertebral bupivacaine consumption was 376.00 ± 33.779 mg in the ultrasound group and 471.50 ± 64.341 mg in the thoracoscope group ( p  < 0.001). Technical difficulties and complications in terms of time consumed during the maneuver, more than one needle pass, and pleural puncture were significantly lower in the ultrasound group than in the thoracoscope group.
CONCLUSION


Ultrasound-guided paravertebral catheter insertion is more effective, technically easier, and safer than the thoracoscope-assisted technique.",2020,"RESULTS


Total analgesic consumption in the first 24 hours was less in the ultrasound group than in the thoracoscope group (rescue intravenous fentanyl 121.25 ± 64.01 µg in the ultrasound group vs. 178.75 ± 91.36 µg in the thoracoscope group;  p  = 0.027).",['40 adults scheduled for elective thoracic surgery'],"['Ultrasound-guided paravertebral catheter insertion', 'Ultrasound versus thoracoscopic-guided paravertebral block during thoracotomy', 'ultrasound-guided paravertebral block with the thoracoscopic technique', 'ultrasound group or a thoracoscope group']","['pleural puncture', 'Total analgesic consumption', 'Total analgesic consumption, visual analogue pain score, technical difficulties, and complications', 'Total paravertebral bupivacaine consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183932', 'cui_str': 'Thoracoscope'}]","[{'cui': 'C0189477', 'cui_str': 'Thoracentesis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",40.0,0.0465168,"RESULTS


Total analgesic consumption in the first 24 hours was less in the ultrasound group than in the thoracoscope group (rescue intravenous fentanyl 121.25 ± 64.01 µg in the ultrasound group vs. 178.75 ± 91.36 µg in the thoracoscope group;  p  = 0.027).","[{'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Hegazy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Gehad', 'Initials': 'G', 'LastName': 'Awad', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohamed Elshabrawy', 'Initials': 'ME', 'LastName': 'Saleh', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sanad', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Mansoura University, Egypt.'}]",Asian cardiovascular & thoracic annals,['10.1177/0218492320965015']
2660,33022096,Quality-adjusted survival with first-line cabozantinib or sunitinib for advanced renal cell carcinoma in the CABOSUN randomized clinical trial (Alliance).,"BACKGROUND


CABOSUN was a randomized, open-label, phase 2 trial evaluating first-line cabozantinib versus sunitinib in patients with advanced renal cell carcinoma (aRCC). This post hoc analysis evaluated quality-adjusted survival using Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST).
METHODS


Survival plots for cabozantinib and sunitinib (650-day follow-up) were partitioned into 3 health states: time spent before disease progression without toxicity (TWiST; toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] grade 3/4 adverse events), time spent before disease progression with toxicity (TOX; durations of adverse events based on published literature), and time after disease recurrence (relapse) or progression to death (REL). Q-TWiST was the sum of the mean time spent in each state, with each state weighted to reflect patient preferences (from 0 [worst] to 1 [best]) using utility scores. TWiST was always weighted as 1. Overall survival and time to disease progression were based on all randomized patients (157 patients); TOX was based on all randomized and treated patients (150 patients).
RESULTS


Across all utility combinations tested, Q-TWiST was found to be longer with cabozantinib versus sunitinib (range of differences, +24 days to +137 days). Q-TWiST differences that were found to be statistically significant (+92 days [95% confidence interval, 5-178 days] to +137 days [95% confidence interval, 60-214 days]) were of a clinically meaningful effect size (≥80 days), and were based on utility values that included those considered relevant for patients with aRCC (REL utility weight of 0.355, TOX utility weight of 0-1, and TWiST utility weight of 1).
CONCLUSIONS


In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib. These findings may help to inform clinical decision making.
LAY SUMMARY


Cabozantinib and sunitinib are drugs that are used to treat patients with advanced kidney cancer. Clinical trials have shown that cabozantinib offers benefits over sunitinib, giving patients more time before their cancer progresses. It is important that this additional time before disease progression does not come at the expense of patients' quality of life, which can be affected by treatment side effects and/or ongoing cancer symptoms. Both quantity and quality of life are central to optimal treatment. In the current analysis of patients with advanced kidney cancer who were initiating treatment for the first time, cabozantinib provided more quality time before cancer progression compared with sunitinib.",2020,"In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib.","['patients with advanced renal cell carcinoma (aRCC', 'advanced renal cell carcinoma', 'patients with advanced kidney cancer']","['first-line cabozantinib or sunitinib', 'TWiST', 'line cabozantinib versus sunitinib']","['Quality-adjusted survival', 'Overall survival and time to disease progression', 'quantity and quality of life', 'quality time before cancer progression', 'toxicity (TWiST; toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] grade 3/4 adverse events), time spent before disease progression with toxicity (TOX; durations of adverse events based on published literature), and time after disease recurrence (relapse) or progression to death (REL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}]",,0.11722,"In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib.","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Feuilly', 'Affiliation': 'Department of Oncology, Ipsen Pharma SAS, Boulogne-Billancourt Cedex, France.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Analytica Laser, Lörrach, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lister', 'Affiliation': 'Analytica Laser, Lörrach, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Marteau', 'Affiliation': 'Department of Oncology, Ipsen Pharma SAS, Boulogne-Billancourt Cedex, France.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Falchook', 'Affiliation': 'Department of Radiation Oncology, Memorial Cancer Institute, Pembroke Pines, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Darren R', 'Initials': 'DR', 'LastName': 'Feldman', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.33169']
2661,33022140,Clinical and demographic characteristics of people who smoke versus inject crystalline methamphetamine in Australia: Findings from a pharmacotherapy trial.,"INTRODUCTION AND AIMS


There has been a rapid increase in smoking crystalline methamphetamine in Australia. We compare the clinical and demographic characteristics of those who smoke versus inject the drug in a cohort of people who use methamphetamine.
DESIGN AND METHODS


Participants (N = 151) were dependent on methamphetamine, aged 18-60 years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97) methamphetamine. Measures included the Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality). Simultaneous regression was used to identify independent demographic correlates of smoking methamphetamine and to compare the clinical characteristics of participants who smoked versus injected.
RESULTS


Compared to participants who injected methamphetamine, those who smoked methamphetamine were younger and less likely to be unemployed, have a prison history or live alone. Participants who smoked methamphetamine used methamphetamine on more days in the past 4 weeks than participants who injected methamphetamine (26 vs. 19 days, P = 0.001); they did not differ significantly in their severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms (P > 0.05). After adjustment for demographic differences, participants who smoked had lower craving [b (SE) = -1.1 (0.5), P = 0.021] and were less likely to report psychotic symptoms [b (SE) = -1.8 (0.7), P = 0.013] or antidepressant use [b (SE) = -1.1 (0.5), P = 0.022].
DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.",2020,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","['people who smoke versus inject crystalline methamphetamine in Australia', 'participants who smoked versus injected', 'Participants (N = 151) were dependent on methamphetamine, aged 18-60\u2009years, enrolled in a pharmacotherapy trial for methamphetamine dependence, and reported either injecting (n = 54) or smoking (n = 97']","['antidepressant use [b (SE) ', 'methamphetamine']","['severity of methamphetamine dependence, withdrawal, craving or psychiatric symptoms', 'Timeline Followback, Severity of Dependence Scale, Amphetamine Withdrawal Questionnaire, Craving Experience Questionnaire and the Brief Psychiatric Rating Scale (symptoms of depression, hostility, psychosis and suicidality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0236665', 'cui_str': 'Amphetamine withdrawal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",151.0,0.0762108,"DISCUSSION AND CONCLUSIONS


Smoking crystalline methamphetamine is associated with a younger less marginalised demographic profile than injecting methamphetamine, but a similarly severe clinical profile.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McKetin', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Quinn', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Higgs', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'Centre for Brain and Mental Health Priority Research Centre, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Ramez', 'Initials': 'R', 'LastName': 'Bathish', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Dayle', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Saunders', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wrobel', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Alcyone', 'Initials': 'A', 'LastName': 'Meehan', 'Affiliation': 'Deakin University, IMPACT-The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Geelong, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sinclair', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reid', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Arunogiri', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Mental Health and Drug and Alcohol Services, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cordaro', 'Affiliation': 'Drug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13183']
2662,33022148,Vocal music enhances memory and language recovery after stroke: pooled results from two RCTs.,"OBJECTIVE


Previous studies suggest that daily music listening can aid stroke recovery, but little is known about the stimulus-dependent and neural mechanisms driving this effect. Building on neuroimaging evidence that vocal music engages extensive and bilateral networks in the brain, we sought to determine if it would be more effective for enhancing cognitive and language recovery and neuroplasticity than instrumental music or speech after stroke.
METHODS


Using data pooled from two single-blind randomized controlled trials in stroke patients (N = 83), we compared the effects of daily listening to self-selected vocal music, instrumental music, and audiobooks during the first 3 poststroke months. Outcome measures comprised neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages.
RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients. Voxel-based morphometry and resting-state and task-based fMRI results showed that vocal music listening selectively increased gray matter volume in left temporal areas and functional connectivity in the default mode network.
INTERPRETATION


Vocal music listening is an effective and easily applicable tool to support cognitive recovery after stroke as well as to enhance early language recovery in aphasia. The rehabilitative effects of vocal music are driven by both structural and functional plasticity changes in temporoparietal networks crucial for emotional processing, language, and memory.",2020,"RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","['after stroke', 'stroke patients (N\xa0=\xa083']","['Voxel-based morphometry and resting-state and task-based fMRI', 'vocal music listening', 'daily music listening', 'daily listening to self-selected vocal music, instrumental music, and audiobooks']","['gray matter volume in left temporal areas and functional connectivity', 'neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages', 'Vocal music enhances memory and language recovery', 'verbal memory recovery']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.359863,"RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","[{'ForeName': 'Aleksi J', 'Initials': 'AJ', 'LastName': 'Sihvonen', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Leo', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ripollés', 'Affiliation': 'Department of Psychology, New York University, New York, New York.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Lehtovaara', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Ylönen', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Rajanaro', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Laitinen', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Forsblom', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Saunavaara', 'Affiliation': 'Department of Medical Physics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Autti', 'Affiliation': 'Department of Radiology, HUS Medical Imaging Center, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rodríguez-Fornells', 'Affiliation': ""Cognition and Brain Plasticity Group, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Tervaniemi', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Soinila', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Särkämö', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51217']
2663,33022197,"Evaluating the Safety and Efficacy of a Topical Formulation Containing Epidermal Growth Factor, Tranexamic Acid, Vitamin C, Arbutin, Niacinamide and Other Ingredients as Hydroquinone 4% Alternatives to Improve Hyperpigmentation: A Prospective, Randomized, Controlled Split Face Study.","Hyperpigmentation is a common concern of patients in aesthetic practice. There are various treatment options, but topical depigmenting agents such as hydroquinone (HQ) are usually a first-line option. Given HQ's side effects and potential controversy over its long-term use from prior animal studies, there is a consumer demand for non-HQ topical formulations that provide similar efficacy, but with a reduced adverse reaction profile to HQ. There is increasing evidence to support the use of selective growth factors, tranexamic acid, niacinamide, arbutin, and Vitamin C in improving hyperpigmentation. This study sought to determine whether a non-HQ topical formulation, composed of the aforementioned ingredients, could provide similar or improved efficacy to topical HQ, but with a reduced adverse reaction profile. This single-center, prospective, randomized, controlled split face study investigated the safety and efficacy of a proprietary product SKNB19 compared with hydroquinone 4% (HQ4%) in treating hyperpigmentation. Eighteen adult subjects with facial pigmentation were randomly assigned to have one side of their face treated with SKNB19 twice a day (morning and night application) and the other treated with HQ4% applied nightly. Patients used a 5-point scale to self-assess their overall appearance, and a 4-point scale to assess redness, irritation, and tolerability to the skin-brightening creams. A Wilcoxon signed-rank test was used to test whether there was a statistical difference between the two treatments. Three-dimensional imaging was performed before treatment was administered and again 1 month following treatment initiation using a Canfield Vectra 3D imaging system. Five independent reviewers comprising two dermatologists, two facial plastic surgeons, and one oculoplastic surgeon graded and performed a qualitative comparative assessment of each side of the face using the before and after images. A Wilcoxon signed-rank test was used to test whether there was a statistical difference in overall appearance between SKNB19- and HQ4%-treated sides. SKNB19-treated hyperpigmentation had a statistically significant improvement in the overall appearance of hyperpigmentation and was shown to be 28.5% better than HQ4%-treated skin in the patient self-assessment and 27% better than HQ4%-treated skin in the independent reviewer assessment. On pair-wise comparison, the independent reviewer assessment also showed that 88.2% of the SKNB19-treated sides appeared equal or better than the HQ4%-treated sides. One patient dropped out of the study because of severe intolerance to HQ4%. No patients experienced intolerance to SKNB19, and all were able to continue its use without adverse effects. SKNB19-treated hyperpigmentation also had a statistically significant reduction in irritation when compared with HQ4%-treated hyperpigmentation. Patients reported a reduction in redness when using SKNB19 as opposed to HQ4%, but these figures did not reach statistical significance. This study supports that SKNB19, a recently developed non-HQ proprietary product, is safe and effective in improving hyperpigmentation. SKNB19 significantly improved the appearance of hyperpigmentation when compared with HQ4% in both patient self-assessment and independent reviewer assessment. SKNB19 exhibited a lower adverse reaction profile and was significantly better tolerated than HQ4%. SKNB19 should be considered as a safe and effective non-HQ alternative for the management of hyperpigmentation.",2020,SKNB19 significantly improved the appearance of hyperpigmentation when compared with HQ4% in both patient self-assessment and independent reviewer assessment.,['Eighteen adult subjects with facial pigmentation'],"['hydroquinone', 'Topical Formulation Containing Epidermal Growth Factor, Tranexamic Acid, Vitamin C, Arbutin, Niacinamide and Other Ingredients as Hydroquinone', 'SKNB19', 'HQ4% applied nightly', 'proprietary product SKNB19']","['overall appearance of hyperpigmentation', 'adverse reaction profile', 'irritation', 'safety and efficacy', '5-point scale to self-assess their overall appearance, and a 4-point scale to assess redness, irritation, and tolerability to the skin-brightening creams', 'appearance of hyperpigmentation', 'reduction in redness', 'Hyperpigmentation']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0003729', 'cui_str': 'Arbutin'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",18.0,0.0283805,SKNB19 significantly improved the appearance of hyperpigmentation when compared with HQ4% in both patient self-assessment and independent reviewer assessment.,"[{'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Kalasho', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Ardalan', 'Initials': 'A', 'LastName': 'Minokadeh', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Zhang-Nunes', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Zoumalan', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Nima L', 'Initials': 'NL', 'LastName': 'Shemirani', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Waldman', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Pletzer', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Zoumalan', 'Affiliation': 'Zoumalan Plastic Surgery, Beverly Hills, CA (B.D.K., R.A.Z., C.I.Z.), Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA (A.M.), Department of Ophthalmology, Keck School of Medicine of USC, Los Angeles, CA (S.Z.-N.), Eos Rejuvenation, Beverly Hills, CA(N.L.S.), Albert Einstein College of Medicine, Montefiore Medical Center, New York, NY (A.R.W.), KlinConsult, Wellington, New Zealand (V.P.).'}]",Journal of cosmetic science,[]
2664,33022367,Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support.,"Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes. Participants (N = 812) were randomly assigned to a telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1 year, delivered by a health educator, or to a comparison condition of enhanced usual care. The primary outcome is change in A1C over one year, measured at baseline and again approximately 6- and 12-months later. Secondary outcomes measured on the same schedule include blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors. A comprehensive effectiveness evaluation is guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to gather data that can inform dissemination and implementation of the intervention, if successful. This paper describes the study rationale, trial design, and methodology.",2020,"Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes.","['predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C\u202f≥\u202f7.5% despite being prescribed medications for diabetes', 'Participants (N\u202f=\u202f812']","['telephone-delivered type 2 diabetes self-management support', 'telephonic intervention condition with a stepped protocol of 6-12 phone calls over 1\u202fyear, delivered by a health educator, or to a comparison condition of enhanced usual care', 'New York City (NYC']","['change in A1C over one year', 'blood pressure, patient-reported emotional distress, treatment adherence and self-management behaviors']","[{'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",812.0,0.067096,"Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults with suboptimally controlled T2D. English- and Spanish-speaking adults treated for T2D in NYC primary care practices were recruited based on having an A1C ≥ 7.5% despite being prescribed medications for diabetes.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA; Departments of Medicine (Endocrinology) and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA; The Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: jeffrey.gonzalez@yu.edu.'}, {'ForeName': 'Claire J', 'Initials': 'CJ', 'LastName': 'Hoogendoorn', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Linnell', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fishman', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jonas', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Departments of Medicine (Endocrinology) and Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, USA; The Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Long Island City, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106166']
2665,33022395,Pilot Study Using Neurofeedback as a Tool to Reduce Surgical Resident Burnout.,"BACKGROUND


Burnout is prevalent among surgical residents. Neurofeedback is a technique to train the brain self-regulation skills. We aimed to assess the impact of neurofeedback on the cognitive workload and personal growth areas of surgery residents with burnout and depression.
STUDY DESIGN


Fifteen surgical residents with burnout (Maslach Burnout Inventory [MBI] score > 27) and depression (Patient Health Questionnaire-9 Depression Screen [PHQ-9] score >10) from one academic institution were enrolled and participated in this institutional review board approved prospective study. Ten residents with more severe burnout and depression scores were assigned to receive eight weeks of neurofeedback treatments, and 5 others with less severe symptoms were treated as controls. Each participant's cognitive workload (or mental effort) was assessed initially, and again following treatment via electroencephalogram (EEG) while the subjects performed n-back working memory tasks. Analysis of variance (ANOVA) tested for significance between the degree of change in the treatment and control groups. Each subject was also asked to rate changes in growth areas, such as sleep and stress.
RESULTS


Both groups showed high cognitive workload in the pre-assessment. After the neurofeedback intervention, the treatment group showed a significant (p <0.01) improvement in cognitive workload via EEG during the working memory task. These differences were not noted in the control group. There was significant correlation between time (NFB sessions) and average improvement in all growth areas (r=0.98) CONCLUSIONS: Residents demonstrated high levels of burnout, correlating with EEG patterns indicative of PTSD. There was a notable change in cognitive workload following the neurofeedback treatment, suggesting a return to a more efficient neural network.",2020,"There was a notable change in cognitive workload following the neurofeedback treatment, suggesting a return to a more efficient neural network.","['surgery residents with burnout and depression', 'score >10) from one academic institution were enrolled and participated in this institutional review board approved prospective study', 'surgical residents', 'Fifteen surgical residents with burnout (Maslach Burnout Inventory [MBI] score > 27) and depression (Patient Health Questionnaire-9 Depression Screen [PHQ-9', 'Ten residents with more severe burnout and depression scores']",[],"['cognitive workload (or mental effort', 'cognitive workload via EEG', 'cognitive workload']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",[],"[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",10.0,0.0226451,"There was a notable change in cognitive workload following the neurofeedback treatment, suggesting a return to a more efficient neural network.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kratzke', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill, NC. Electronic address: Ian.Kratzke@unchealth.unc.edu.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Mae N', 'Initials': 'MN', 'LastName': 'Yefimov', 'Affiliation': 'Neurocognition and Imaging Research Lab, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Prithima R', 'Initials': 'PR', 'LastName': 'Mosaly', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Adapa', 'Affiliation': 'Division of Healthcare Engineering, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Farrell', 'Affiliation': 'Department of Surgery, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Lukasz M', 'Initials': 'LM', 'LastName': 'Mazur', 'Affiliation': 'Division of Healthcare Engineering, University of North Carolina, Chapel Hill, NC.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.08.762']
2666,33022417,A Randomized clinical trial evaluating Photodithazine-mediated Antimicrobial Photodynamic Therapy as a treatment for denture stomatitis.,"OBJECTIVE


This randomized clinical trial assessed antimicrobial Photodynamic Therapy (aPDT) mediated by Photodithazine (PDZ) to treat patients with denture stomatitis (DS).
METHODOLOGIES


Patients with DS were randomly assigned to the groups: aPDT (n = 30) and nystatin (NYS, n = 35). aPDT patients received 6 aPDT sessions, three times a week for 15 days, which involved PDZ (200 mg/L) topical application (20 min) on the palate and upper denture, followed by LED illumination (660 nm, 50 J/cm²). NYS patients were instructed to rinse one dropper of this medication for one minute, four times a day, for 15 days. Microbiological collections of dentures and palates were performed and cultured on blood agar and CHROMAgar Candida. Microbial viability was determined, and photographs of the palates were taken for clinical evaluation. Data were analyzed by Repeated Measure Linear Model and Bonferroni (p ≤ 0.05).
RESULTS


aPDT was more effective to reduce the total microbiota than NYS. At the end of the treatments, aPDT reduced 1.98 from the palate and 1.91 log 10  from the denture, while NYS reduced 0.05 and 0.17 log 10 , respectively. Moreover, aPDT was as effective as NYS to reduce Candida. Reductions of 0.68 and 0.77 log 10  were observed in the palate and denture of aPDT group, while reductions of 0.57 and 1.43 log 10  were achieved in the NYS group, respectively. Regarding to oral lesion, 53.3 and 54.2% of the patients from aPDT and NYS groups had clinical improvement. However, the recurrence of DS was observed in both groups.
CONCLUSION


PDZ-mediated aPDT is a promising treatment for DS.",2020,"Reductions of 0.68 and 0.77 log 10  were observed in the palate and denture of aPDT group, while reductions of 0.57 and 1.43 log 10  were achieved in the NYS group, respectively.","['denture stomatitis', 'patients with denture stomatitis (DS', 'Patients with DS']","['Photodithazine-mediated Antimicrobial Photodynamic Therapy', 'Photodithazine (PDZ', 'PDZ (200\u2009mg/L) topical application (20\u2009min) on the palate and upper denture, followed by LED illumination', 'nystatin', 'PDZ-mediated aPDT', 'antimicrobial Photodynamic Therapy (aPDT', 'aPDT']","['recurrence of DS', 'total microbiota', 'Microbial viability']","[{'cui': 'C0038364', 'cui_str': 'Denture stomatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1670079', 'cui_str': 'N-methyl glucosamine chlorine e6 salt'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038364', 'cui_str': 'Denture stomatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1563770', 'cui_str': 'Microbial Viability'}]",,0.0302274,"Reductions of 0.68 and 0.77 log 10  were observed in the palate and denture of aPDT group, while reductions of 0.57 and 1.43 log 10  were achieved in the NYS group, respectively.","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Alves', 'Affiliation': 'Biophotonics Lab, Group of Optics, Physics Institute of São Carlos, University of São Paulo - USP, Av. Trabalhador São-carlense, 400, 13566-590, São Carlos, SP, Brazil.'}, {'ForeName': 'Juliana Cabrini', 'Initials': 'JC', 'LastName': 'Carmello', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (Unesp), School of Dentistry, Araraquara, Rua Humaitá, 1680, 14801-903, Araraquara, SP, Brazil.'}, {'ForeName': 'Gabriela Caroline', 'Initials': 'GC', 'LastName': 'Alonso', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (Unesp), School of Dentistry, Araraquara, Rua Humaitá, 1680, 14801-903, Araraquara, SP, Brazil.'}, {'ForeName': 'Ewerton Garcia', 'Initials': 'EG', 'LastName': 'de Oliveira Mima', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (Unesp), School of Dentistry, Araraquara, Rua Humaitá, 1680, 14801-903, Araraquara, SP, Brazil.'}, {'ForeName': 'Vanderlei Salvador', 'Initials': 'VS', 'LastName': 'Bagnato', 'Affiliation': 'Biophotonics Lab, Group of Optics, Physics Institute of São Carlos, University of São Paulo - USP, Av. Trabalhador São-carlense, 400, 13566-590, São Carlos, SP, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Pavarina', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (Unesp), School of Dentistry, Araraquara, Rua Humaitá, 1680, 14801-903, Araraquara, SP, Brazil. Electronic address: pavarina@foar.unesp.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102041']
2667,33022483,The Norwegian healthy body image intervention promotes positive embodiment through improved self-esteem.,"We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students. In total, 2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. We tested mediation models using path analysis and found that among several hypothesized mediators, only self-esteem mediated a positive intervention effect on positive embodiment for both boys and girls. A direct effect of the intervention on positive embodiment was only found in girls. The study provides novel findings indicating that health promotion interventions to address a positive embodiment should focus on enhancing adolescent's self-esteem. Serial mediation modeling might reveal more complex explanations of change mechanisms and could further evolve current knowledge.",2020,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"['girls', 'Norwegian high school students', '2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the']","['HBI intervention', 'Healthy Body Image (HBI) intervention']",['positive embodiment'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0192935,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: chrsun@ous-hf.no.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Umeå University, Department of Psychology, 901 87 Umeå, Sweden. Electronic address: andreas.stenling@umu.se.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: jan.rosenvinge@uit.no.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, N- 9037 Tromsø, Norway. Electronic address: gunn.pettersen@uit.no.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: oddgeir.friborg@uit.no.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: jorunn.sundgot-borgen@nih.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: elin.kolle@nih.no.'}, {'ForeName': 'Monica Klungland', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Postbox 422, 4604 Kristiansand, Norway. Electronic address: monica.k.torstveit@uia.no.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Svantorp-Tveiten', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: k.m.e.engen@nih.no.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, P.O. Box 235, N-3603 Kongsberg, Norway. Electronic address: Solfrid.Bratland-Sanda@usn.no.'}]",Body image,['10.1016/j.bodyim.2020.08.014']
2668,33022653,Cardiometabolic and Perceptual Responses to Body-Weight Resistance High-Intensity Interval Exercise in Boys.,"The majority of studies examining children's responses to high-intensity interval exercise primarily utilized running; however, this modality does not require/include other important aspects of physical activity including muscular fitness.
PURPOSE


To compare acute responses between a body weight resistance exercise circuit (CIRC) and treadmill-based (TM) high-intensity interval exercise.
METHOD


A total of 17 boys (age = 9.7 [1.3] y) completed a graded exercise test to determine peak heart rate, peak oxygen uptake (VO2peak), and maximal aerobic speed. Sessions were randomized and counterbalanced. CIRC required 2 sets of 30-second maximal repetitions of 4 exercises. TM included eight 30-second bouts of running at 100% maximal aerobic speed. Both included 30-second active recovery between bouts. Blood lactate concentration was measured preexercise and postexercise. Rating of perceived exertion, affective valence, and enjoyment were recorded preexercise, after intervals 3 and 6, and postexercise.
RESULTS


Participants attained 88% (5%) peak heart rate and 74% (9%) VO2peak for CIRC and 89% (4%) peak heart rate and 81% (6%) VO2peak for TM, with a significant difference in percentage of VO2peak (P = .003) between protocols. Postexercise blood lactate concentration was higher following CIRC (5.0 [0.7] mM) versus TM (2.0 [0.3] mM) (P < .001). Rating of perceived exertion, affective valence, and enjoyment responses did not differ between protocols (P > .05).
CONCLUSION


HR responses were near maximal during CIRC, supporting that this body-weight circuit is representative of high-intensity interval exercise.",2020,"Rating of perceived exertion, affective valence, and enjoyment responses did not differ between protocols (P > .05).
","['A total of 17 boys (age = 9.7 [1.3]\xa0y) completed a', 'Boys']","['body weight resistance exercise circuit (CIRC) and treadmill-based (TM) high-intensity interval exercise', 'Body-Weight Resistance High-Intensity Interval Exercise', 'graded exercise test']","['peak heart rate, peak oxygen uptake (VO2peak), and maximal aerobic speed', 'peak heart rate', 'percentage of VO2peak', 'Rating of perceived exertion, affective valence, and enjoyment', 'Rating of perceived exertion, affective valence, and enjoyment responses', 'Blood lactate concentration', 'Postexercise blood lactate concentration']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0454286', 'cui_str': 'Exercise circuits'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0892333,"Rating of perceived exertion, affective valence, and enjoyment responses did not differ between protocols (P > .05).
","[{'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Ricci', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'California State University-San Marcos.'}, {'ForeName': 'Katharine D', 'Initials': 'KD', 'LastName': 'Currie', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Michigan State University.'}]",Pediatric exercise science,['10.1123/pes.2020-0040']
2669,33022654,The Efficacy of Simultaneously Training 2 Motion Targets During a Squat Using Auditory Feedback.,"Auditory feedback is a simple, low-cost training solution that can be used in rehabilitation, motor learning, and performance development. The use has been limited to the instruction of a single kinematic or kinetic target. The goal of this study was to determine if auditory feedback could be used to simultaneously train 2 lower-extremity parameters to perform a bodyweight back squat. A total of 42 healthy, young, recreationally active males participated in a 4-week training program to improve squat biomechanics. The Trained group (n = 22) received 4 weeks of auditory feedback. Feedback focused on knee flexion angle and center of pressure under the foot at maximum squat depth. The Control group (n = 20) performed squats without feedback. Subjects were tested pre, post, and 1 week after training. The Trained group achieved average target knee flexion angle within 1.73 (1.31) deg (P < .001) after training and 5.36 (3.29) deg (P < .01) at retention. While achieving target knee flexion angle, the Trained group maintained target center of pressure (P < .001). The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90). Results from this study demonstrate that auditory feedback is an effective way to train 2 independent biomechanical targets simultaneously.",2020,"The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90).","['42 healthy, young, recreationally active males participated in a']","['4-week training program to improve squat biomechanics', 'auditory feedback']","['average target knee flexion angle', 'knee range of motion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}]",42.0,0.0250706,"The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90).","[{'ForeName': 'Rena F', 'Initials': 'RF', 'LastName': 'Hale', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Dorgo', 'Affiliation': 'The University of Texas at El Paso.'}, {'ForeName': 'Roger V', 'Initials': 'RV', 'LastName': 'Gonzalez', 'Affiliation': 'The University of Texas at El Paso.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Hausselle', 'Affiliation': 'Oklahoma State University.'}]",Journal of applied biomechanics,['10.1123/jab.2019-0276']
2670,33022678,"Effect of Progressive Resistance Training on Circulating Adipogenesis-, Myogenesis-, and Inflammation-Related microRNAs in Healthy Older Adults: An Exploratory Study.","BACKGROUND


Functional and physiological adaptations induced by resistance training have been extensively studied in older adults. However, microRNA (miRNA) as the novel regulator in protective effects remains poorly understood.
OBJECTIVE


The purpose of an exploratory study was to analyze the response of a panel of circulating miRNAs to adaptations mediated by resistance training.
METHODS


Ten healthy older adults (age: 67.6 ± 2.2 years, 7 women and 3 men) without previous experience in resistance training were recruited. Blood samples were collected at baseline and after a 12-week resistance training. Next-generation sequencing was used to determine circulating miRNA responses to chronic resistance training.
RESULTS


After the 12-week training, physical functions including grip strength, lower body strength and endurance, and walking capacity were improved in the older adults, while the serum levels of leptin (from 18.1 ± 20.0 to 14.9 ± 17.6 ng/mL, p = 0.029) and tumor necrosis factor alpha (TNFα; from 4.4 ± 0.6 to 4.0 ± 0.6 pg/mL, p < 0.001) were significantly decreased. In addition, adipogenesis-related miRNAs (miR-103a-3p, -103b, -143-5p, -146b-3p, -146b-5p, -17-5p, -181a-2-3p, -181b-5p, -199a-5p, -204-3p, and -378c), anti-adipogenesis-related miRNAs (miR-155-3p, -448, and -363-3p), myogenesis-related miRNAs (miR-125b-1-3p, -128-3p, -133a-3p, 155-3p, -181a-2-3p, -181b-5p, -199a-5p, -223-3p, and -499a-5p), and inflammation-related miRNAs (miR-146b-3p, -146b-5p, -155-3p, -181a-2-3p, and -181b-5p) were changed significantly in the older adults after training (fold change >2, p < 0.05). The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1 (R = -0.644, p = 0.044).
CONCLUSIONS


Our results can help explain the link between specific circulating miRNAs and beneficial effects of resistance training on functional and physiological adaptations in older adults.",2020,"The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1","['older adults', 'Healthy Older Adults', 'Ten healthy older adults (age: 67.6 ± 2.2 years, 7 women and 3 men) without previous experience in resistance training were recruited']","['Progressive Resistance Training', 'resistance training']","['change in insulin-like growth factor 1', 'Blood samples', 'delta walking time', 'Circulating Adipogenesis-, Myogenesis-, and Inflammation-Related microRNAs', 'serum levels of leptin', 'physical functions including grip strength, lower body strength and endurance, and walking capacity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",10.0,0.0248945,"The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1","[{'ForeName': 'Hung-Wen', 'Initials': 'HW', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan, hwliu@ntnu.edu.tw.'}, {'ForeName': 'Hao-Chien', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Shun-Hsi', 'Initials': 'SH', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Hsien', 'Initials': 'WH', 'LastName': 'Sun', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Gerontology,['10.1159/000510148']
2671,33022713,Risk of keratinocyte carcinomas with vitamin D and calcium supplementation: a secondary analysis of a randomized clinical trial.,"BACKGROUND


It is unknown whether dietary supplementation with vitamin D or calcium prevents keratinocyte carcinomas, also known as nonmelanoma skin cancers.
OBJECTIVES


This study aimed to determine whether daily vitamin D or calcium supplementation alters the risk of basal cell carcinoma (BCC) or invasive cutaneous squamous cell carcinoma (SCC).
METHODS


The Vitamin D/Calcium Polyp Prevention Study is a completed multicenter, double-blind, placebo-controlled, partial 2 × 2 factorial, randomized clinical trial of vitamin D, calcium, or both for the prevention of colorectal adenomas. During 2004-2008, a total of 2259 men and women, 45-75 y of age, recently diagnosed with a colorectal adenoma, were randomly assigned to 1000 IU/d of vitamin D3 or placebo and 1200 mg/d of calcium carbonate or placebo for 3 or 5 y, and followed after treatment ended. Reports of incident BCC or SCC were confirmed from pathology records.
RESULTS


During a median follow-up of 8 y, 200 (9%) participants were diagnosed with BCC and 68 (3%) participants were diagnosed with SCC. BCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.96; 95% CI: 0.73, 1.26), calcium compared with no calcium (HR: 1.01; 95% CI: 0.74, 1.39), and both agents compared with neither (HR: 0.99; 95% CI: 0.65, 1.51). SCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.79; 95% CI: 0.49, 1.27), but there was suggestive evidence of beneficial treatment effects for calcium compared with no calcium (HR: 0.60; 95% CI: 0.36, 1.01) and both agents compared with neither (HR: 0.42; 95% CI: 0.19, 0.91).
CONCLUSIONS


Calcium alone or in combination with vitamin D may reduce the risk of SCC, but not BCC. This trial was registered at clinicaltrials.gov as NCT00153816.",2020,"SCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.79; 95% CI: 0.49, 1.27), but there was suggestive evidence of beneficial treatment effects for calcium compared with no calcium (HR: 0.60; 95% CI: 0.36, 1.01) and both agents compared with neither (HR: 0.42; 95% CI: 0.19, 0.91).
","['invasive cutaneous squamous cell carcinoma (SCC', 'During 2004-2008, a total of 2259 men and women, 45-75 y of age, recently diagnosed with a colorectal adenoma']","['vitamin D and calcium supplementation', 'vitamin D, calcium', 'vitamin D', 'vitamin D3 or placebo', 'vitamin D or calcium', 'calcium carbonate or placebo', 'placebo', 'daily vitamin D or calcium supplementation', 'Calcium alone or in combination with vitamin D']","['SCC incidence', 'BCC incidence', 'risk of SCC', 'risk of basal cell carcinoma (BCC']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2259.0,0.757655,"SCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.79; 95% CI: 0.49, 1.27), but there was suggestive evidence of beneficial treatment effects for calcium compared with no calcium (HR: 0.60; 95% CI: 0.36, 1.01) and both agents compared with neither (HR: 0.42; 95% CI: 0.19, 0.91).
","[{'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Karagas', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa267']
2672,33022718,Investigating the Effect of Fresh Frozen Plasma and Albumin on DNA Damage and Oxidative Stress Biomarkers in Poisoning Cases by Organophosphates.,"The efficacy of albumin and fresh frozen plasma (FFP) and their effects on biomarkers of oxidative stress has been evaluated. In a randomized clinical control trial, 33 poisoned patients by Organophosphate (OP) were enrolled in the research and divided into three groups. The first group underwent conventional treatments by atropine and pralidoxime (control group); the second and third groups, in addition to traditional treatments, received albumin and FFP. Cholinesterase (ChE) enzyme activity, total antioxidant capacity (TAC), serum thiol groups (TTG), malonyl aldehyde (MDA) and DNA damage were measured in all treatment and control groups. Patients were matched in terms of demographic characteristics at the beginning of the study. ChE activity was increased in all three groups during treatment, which was more noticeable in the FFP group and was statistically significant in both albumin and FFP group compared to the control group (p<0.05). TAC increased, and TTG decreased in FFP and albumin groups compared to the control group; no significant difference was observed. MDA decreased in albumin and FFP and was significantly different in the FFP group compared to the control group (p<0.05). The amount of DNA damage in FFP and albumin groups decreased, and there was a significant difference compared to the control group (p<0.05). According to the results of this study, due to the decrease of oxidative damage parameters and the increase of antioxidant parameters in albumin and specially FFP groups, FFP may be considered as an adjunctive treatment for OP poisoning.",2020,"The amount of DNA damage in FFP and albumin groups decreased, and there was a significant difference compared to the control group (p<0.05).","['Poisoning Cases by Organophosphates', '33 poisoned patients by Organophosphate (OP']","['atropine and pralidoxime', 'albumin and fresh frozen plasma (FFP', 'FFP', 'albumin and FFP', 'Fresh Frozen Plasma and Albumin']","['MDA decreased in albumin and FFP', 'DNA Damage and Oxidative Stress Biomarkers', 'Cholinesterase (ChE) enzyme activity, total antioxidant capacity (TAC), serum thiol groups (TTG), malonyl aldehyde (MDA) and DNA damage', 'ChE activity', 'TAC increased, and TTG']","[{'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031701', 'cui_str': 'Phosphoric acid ester'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0071808', 'cui_str': 'pralidoxime'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}]","[{'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008429', 'cui_str': 'Cholinesterase'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001992', 'cui_str': 'Aldehyde'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",33.0,0.0164634,"The amount of DNA damage in FFP and albumin groups decreased, and there was a significant difference compared to the control group (p<0.05).","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Afzali', 'Affiliation': 'Department of Forensic Medicine and Toxicology, School of Medicine, Hamadan University of Medical Sciences, Hamadan.'}, {'ForeName': 'Manoochehr', 'Initials': 'M', 'LastName': 'Karami', 'Affiliation': 'Department of Epidemiology, School of Public Health Hamadan University of Medical Sciences, Hamadan.'}, {'ForeName': 'Nejat', 'Initials': 'N', 'LastName': 'Kheyripour', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ranjbar', 'Affiliation': 'Nutrition Health Research Center, Hamadan University of Medical Sciences, Hamadan.'}]",Drug research,['10.1055/a-1261-9151']
2673,33022736,Influence of Sprint Duration during Minimal Volume Exercise on Aerobic Capacity and Affect.,"The aims of this study were to investigate the influence of reduced-exertion, high-intensity interval training (REHIT), comparing a novel shortened-sprint protocol (SSREHIT) against a traditional protocol (TREHIT), on perceptual responses and to determine if changes in peak oxygen uptake (V˙O 2peak ) are attenuated with shorter sprints. Twenty-four healthy men undertook 15 sessions of SSREHIT or TREHIT. V˙O 2peak  was determined at baseline and after completion of each exercise condition. Affective (pleasure-displeasure) responses and perceived exertion were assessed during exercise to capture peak responses. Enjoyment was recorded 5-min after cessation of exercise. Compared to baseline, V˙O 2peak  increased in both groups (6% for SSREHIT [ d =- 0.36] and 9% for TREHIT [ d= - 0.53], p=0.01). Affective responses were more favourable for SSREHIT (p=0.001,  d =1.62), but both protocols avoided large negative peaks of displeasure. Peak ratings of perceived exertion were lower for SSREHIT (p=0.001,  d =- 1.71), although there were no differences in enjoyment ( d =0.25). The results demonstrate both exercise conditions can increase V˙O 2peak  without overly compromising perceptual responses. Decreased sprint duration might further circumvent negative perceptual responses but might also attenuate physiological adaptations.",2020,"Affective responses were more favourable for SSREHIT (p=0.001,  d =1.62), but both protocols avoided large negative peaks of displeasure.",['Twenty-four healthy men undertook 15 sessions of'],"['reduced-exertion, high-intensity interval training (REHIT), comparing a novel shortened-sprint protocol (SSREHIT) against a traditional protocol (TREHIT', 'SSREHIT', 'SSREHIT or TREHIT']","['V˙O 2peak', 'Enjoyment', 'Affective (pleasure-displeasure) responses and perceived exertion', 'Affective responses', 'peak oxygen uptake (V˙O 2peak ', 'Peak ratings of perceived exertion']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",24.0,0.0311648,"Affective responses were more favourable for SSREHIT (p=0.001,  d =1.62), but both protocols avoided large negative peaks of displeasure.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Haines', 'Affiliation': 'Department of Allied Health Professions, Sport and Exercise, University of Huddersfield, Huddersfield.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stephenson', 'Affiliation': 'Department of Allied Health Professions, Sport and Exercise, University of Huddersfield, Huddersfield.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Gillibrand', 'Affiliation': 'Department of Nursing and Midwifery, University of Huddersfield, Huddersfield.'}]",International journal of sports medicine,['10.1055/a-1255-3161']
2674,33022911,"Free-Weight Resistance Exercise Is More Effective in Enhancing Inhibitory Control than Machine-Based Training: A Randomized, Controlled Trial.","Resistance exercise has been demonstrated to improve brain function. However, the optimal workout characteristics are a matter of debate. This randomized, controlled trial aimed to elucidate differences between free-weight (RE free ) and machine-based (RE mach ) training with regard to their ability to acutely enhance cognitive performance (CP). A total of  n  = 46 healthy individuals (27 ± 4 years, 26 men) performed a 45-min bout of RE free  (military press, barbell squat, bench press) or RE mach  (shoulder press, leg press, chest press). Pre- and post-intervention, CP was examined using the Stroop test, Trail Making Test and Digit Span test. Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05). However, RE free  was superior to RE mach  in the Stroop color-word condition (+6.3%,  p  = 0.02, R = 0.35). Additionally, RE free  elicited pre-post changes in all parameters except for the Digit Span test and the word condition of the Stroop test while RE mach  only improved cognitive performance in part A of the Trail Making test. Using free weights seems to be the more effective RE method to acutely improve cognitive function (i.e., inhibitory control). The mechanisms of this finding merit further investigation.",2020,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05).","['A total of  n  = 46 healthy individuals (27 ± 4 years, 26 men']","['free-weight (RE free ) and machine-based (RE mach ) training', '45-min bout of RE free  (military press, barbell squat, bench press) or RE mach  (shoulder press, leg press, chest press', 'Resistance exercise', 'Free-Weight Resistance Exercise', 'Pre- and post-intervention']","['cognitive performance', 'Stroop test, Trail Making Test and Digit Span test', 'Digit Span test, Trail Making test and the color and word conditions of the Stroop test', 'brain function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1144061', 'cui_str': 'CASP8 protein, human'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0454325', 'cui_str': 'Shoulder press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",46.0,0.0275825,"Mann-Whitney U tests did not reveal between-group differences for performance in the Digit Span test, Trail Making test and the color and word conditions of the Stroop test ( p  > 0.05).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stricker', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Usedly', 'Affiliation': 'Department of Sports Medicine, Goethe University, Ginnheimer Landstraße 39, 60487 Frankfurt am Main, Germany.'}]",Brain sciences,['10.3390/brainsci10100702']
2675,33022918,"Effects of Moderate Combined Resistance- and Aerobic-Exercise for 12 Weeks on Body Composition, Cardiometabolic Risk Factors, Blood Pressure, Arterial Stiffness, and Physical Functions, among Obese Older Men: A Pilot Study.","We demonstrated the hypothesis that combined exercise improves body composition, cardiometabolic risk factors, blood pressure (BP), arterial stiffness, and physical functions, in obese older men. Older men ( n  = 20) were randomly assigned to combined exercise training (EXP;  n  = 10) or control groups (CON;  n  = 10). The combined exercise was comprised of elastic-band resistance training and walking/running on a treadmill and bicycle at 60-70% of maximal heart rate for 3 days/weeks. EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05). The exercise program significantly reduced BP, mean arterial pressure, pulse pressure, and brachial-ankle pulse wave velocity. Furthermore, while the plasma levels of low-density lipoprotein cholesterol and epinephrine were significantly reduced in EXP, VO 2  peak and grip strength were significantly enhanced ( p  < 0.05). In conclusion, it is indicated that 12-week regular combined exercise improves body composition, cardiometabolic risk factors, hemodynamics, and physical performance in obese older men.",2020,"EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05).","['Older men ( n  = 20', 'Obese Older Men', 'obese older men']","['elastic-band resistance training and walking/running on a treadmill and bicycle', 'combined exercise', 'combined exercise training (EXP;  n  = 10) or control groups (CON', 'Moderate Combined Resistance- and Aerobic-Exercise']","['body composition, cardiometabolic risk factors, hemodynamics, and physical performance', 'Body Composition, Cardiometabolic Risk Factors, Blood Pressure, Arterial Stiffness, and Physical Functions', 'body composition, cardiometabolic risk factors, blood pressure (BP), arterial stiffness, and physical functions', 'plasma levels of low-density lipoprotein cholesterol and epinephrine', 'BP, mean arterial pressure, pulse pressure, and brachial-ankle pulse wave velocity', 'body weight, body mass index, and %body fat', 'EXP, VO 2  peak and grip strength']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",20.0,0.0222169,"EXP showed significant decreases in body weight, body mass index, and %body fat ( p  < 0.05).","[{'ForeName': 'Wonil', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Korea University, 145 Anam-ro, Seongbuk-gu, Seoul 02841, Korea.'}, {'ForeName': 'Won-Sang', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Kwangseok', 'Initials': 'K', 'LastName': 'Hong', 'Affiliation': 'Department of Physical Education, Chung-Ang University, 84 Heukseok-ro, Dongjak-gu, Seoul 06974, Korea.'}, {'ForeName': 'Yae-Young', 'Initials': 'YY', 'LastName': 'Kim', 'Affiliation': 'Department of Oriental Sports Medicine, Daegu Haany University, 1 Haanydaero, Gyeongsan-si, Gyeongsangbuk-Do 38610, Korea.'}, {'ForeName': 'Sung-Woo', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}, {'ForeName': 'Hun-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Physical Activity and Performance Institute (PAPI), Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17197233']
2676,33022957,Short-Term Effects of Salt Restriction via Home Dishes Do Not Persist in the Long Term: A Randomized Control Study.,"Salt intake reduction is crucial to prevent non-communicable diseases (NCDs) globally. This study aimed to investigate the short- and long-term effects of monitoring salt concentration in homemade dishes on reducing salt intake in a Japanese population. A double-blind randomized controlled trial using a 2 × 2 factorial design with two interventions was conducted in 195 participants; they were assigned to both interventions for a group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning). We evaluated 24-hour urinary sodium excretions at baseline and after a three-month intervention for the changes as major outcomes, at six- and twelve-months after baseline as long-term follow-up surveys. Urinary sodium excretion decreased in both intervention and control groups after the intervention. However, differences in the change for both monitoring and low-sodium seasoning interventions were statistically non-significant ( p  = 0.29 and 0.52, respectively). Urinary sodium excretion returned to the baseline level after twelve-months for all groups. Monitoring of salt concentration is ineffective in reducing salt intake for short- and long-term among the people studied in this cohort.",2020,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"['195 participants', 'a Japanese population']","['group monitoring salt concentration in soups (control: no monitoring) and a group using low-sodium seasoning (control: regular seasoning', 'Salt Restriction via Home Dishes']","['24-hour urinary sodium excretions', 'Urinary sodium excretion', 'salt intake']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0453399', 'cui_str': 'Soup'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",195.0,0.0944828,Urinary sodium excretion decreased in both intervention and control groups after the intervention.,"[{'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Maruya', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Ribeka', 'Initials': 'R', 'LastName': 'Takachi', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': ""Department of Food Science and Nutrition, Faculty of Human Life and Environment, Nara Women's University, Kitauoya-Nishimachi, Nara 630-8506, Japan.""}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakadate', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ishihara', 'Affiliation': 'Department of Food and Life Science, Azabu University, 1-17-71 Fuchinobe, Chuo-ku, Sagamihara-city 252-5201, Kanagawa, Japan.'}]",Nutrients,['10.3390/nu12103034']
2677,33022968,Integrated Strength and Fundamental Movement Skill Training in Children: A Pilot Study.,"Competence in fundamental movement skills is essential to enable children to be physically active. We investigated the effect of an integrated fundamental movement skill with a strength training intervention on children's fundamental movement skills. Seventy-two (53% female) 10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance). Schools were randomly allocated to a control (no intervention; n = 21), fundamental movement skill (FMS) (n = 18) or FMS and strength (FMS + ; n = 20) group. Interventions were delivered twice weekly for four weeks, in addition to normal physical education. FMS competence was measured through the Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product). Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1). Clear improvements in CMJ were observed in FMS +  relative to the control (25, 18 to 32%,  p δ  = 0) and FMS groups (15, 6.1 to 24%,  p δ  = 0). These preliminary data suggest combined FMS and strength training warrants further investigation as a tool to develop fundamental movement skills in children.",2020,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1).","['Seventy-two (53% female', ""children's fundamental movement skills"", '10- to 11-year-old children from three primary schools assented to take part in this study (87% compliance', 'children', 'Children']","['Integrated Strength and Fundamental Movement Skill Training', 'integrated fundamental movement skill with a strength training intervention', 'fundamental movement skill (FMS']","['Canadian agility and movement skills assessment (CAMSA) (product-process) and through countermovement jump (CMJ) and 40-m sprint tests (product', 'FMS competence', 'CMJ']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0220531,"Improvements were observed in the CAMSA in both FMS (4.6, 95% confidence intervals 2.9 to 6.4 Arbitrary Units (AUs), second-generation  p -value ( p δ ) = 0.03) and FMS +  (3.9, 2.1 to 5.3 AU,  p δ  = 0.28) with no difference beyond our minimum threshold of 3 AU observed between these intervention groups ( p δ  = 1).","[{'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Grainger', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Innerd', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Department of Science, School of Health and Life Sciences, Teesside University, Middlesbrough TS1 3BX, UK.'}]","Children (Basel, Switzerland)",['10.3390/children7100161']
2678,33022987,Ingestion of  Helianthus tuberosus  at Breakfast Rather Than at Dinner Is More Effective for Suppressing Glucose Levels and Improving the Intestinal Microbiota in Older Adults.,"To date, nutritional studies have focused on the total intake of dietary fiber rather than intake timing. In this study, we examined the effect of the timing of daily  Helianthus   tuberosus  ingestion on postprandial and 24 h glucose levels, as well as on intestinal microbiota in older adults. In total, 37 healthy older adults (age = 74.9 ± 0.8 years) were recruited. The participants were randomly assigned to either a morning group (MG,  n  = 18) or an evening group (EG,  n  = 17). The MG and EG groups were instructed to take  Helianthus   tuberosus  powder (5 g/day) just before breakfast or dinner, respectively, for 1 week after the 1-week control period. The glucose levels of all participants were monitored using a continuous glucose monitoring system throughout the 2 weeks. The intestinal microbiota was analyzed by sequencing 16S rRNA genes from feces before and after the intervention. There were no significant differences in the physical characteristics or energy intake between groups.  Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively). As a result of examining the fluctuations in tissue glucose levels up to 4 hours after each meal, significant decreases in the areas under the curves (AUCs) were observed for all three meals after intervention, but only in the MG (breakfast:  p  = 0.012, lunch:  p  = 0.002, dinner:  p  = 0.005). On the other hand, in the EG, there was a strong decrease in the AUC after dinner, but only slight decreases after breakfast and lunch (breakfast:  p  = 0.017, lunch:  p  = 0.427, dinner:  p  = 0.002). Moreover, the rate of change in the peak tissue glucose level at breakfast was significantly decreased in the MG compared to the EG ( p  = 0.027). A greater decrease was observed in the change in the blood glucose level after the ingestion of  Helianthus   tuberosus  in the MG than in the EG. Furthermore, the relative abundance of  Ruminococcus  in the MG at the genus level was significantly higher at baseline than in the EG ( p  = 0.016) and it was also significantly lower after the intervention ( p  = 0.013). Our findings indicate that  Helianthus   tuberosus  intake in the morning might have relatively stronger effects on the intestinal microbiota and suppress postprandial glucose levels to a greater extent than when taken in the evening.",2020,"Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively).","['older adults', '37 healthy older adults (age = 74.9 ± 0.8 years) were recruited', 'Older Adults']","['morning group (MG,  n  = 18) or an evening group (EG,  n  = 17', 'Ingestion of  Helianthus tuberosus  at Breakfast']","['rate of change in the peak tissue glucose level at breakfast', 'glucose levels', 'postprandial glucose levels', 'blood glucose level', 'relative abundance of  Ruminococcus', 'tissue glucose levels', 'intestinal microbiota', 'postprandial and 24 h glucose levels', 'physical characteristics or energy intake']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0022386', 'cui_str': 'Jerusalem artichoke'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",37.0,0.0193183,"Helianthus   tuberosus  intake led to decreases in tissue glucose levels throughout the day in both groups ( p  < 0.01, respectively).","[{'ForeName': 'Hyeon-Ki', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Chijiki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nanba', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Institute for Liberal Arts, Tokyo Institute of Technology, 2-12-1, Ookayama Meguro-ku, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 162-8480, Japan.'}]",Nutrients,['10.3390/nu12103035']
2679,33022991,An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial.,"BACKGROUND


Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM.
METHODS


This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups.
RESULTS


A-LCD significantly improved depression and HbA1c ( p  <0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria  Roseburia ,  Ruminococcus  and  Eubacterium . The GLP-1 concentration in the a-LCD group was higher than that in the LFD group ( p  <0.05).
CONCLUSIONS


A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.",2020,A-LCD significantly improved depression and HbA1c ( p  <0.01).,"['Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group', 'Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second', 'Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1', 'patients with T2DM']","['LFD', 'LCD with a low-fat diet (LFD', 'Almond-Based Low Carbohydrate Diet', 'almond-based LCD (a-LCD', 'Alow carbohydrate diet (LCD']","['hyperglycemia and depression symptoms', 'glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration', 'GLP-1 concentration', 'depression and HbA1c', 'short chain fatty acid (SCFAs)-producing bacteria  Roseburia ,  Ruminococcus  and  Eubacterium ']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}]",45.0,0.0354016,A-LCD significantly improved depression and HbA1c ( p  <0.01).,"[{'ForeName': 'Mengxiao', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA 94110, USA.'}, {'ForeName': 'Jindan', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}, {'ForeName': 'Omorogieva', 'Initials': 'O', 'LastName': 'Ojo', 'Affiliation': 'School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London SE9 2UG, UK.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Medical College, Soochow University, Suzhou 215006, China.'}]",Nutrients,['10.3390/nu12103036']
2680,33023060,Addition of Probiotics to Anti-Obesity Therapy by Percutaneous Electrical Stimulation of Dermatome T6. A Pilot Study.,"Obesity is becoming a pandemic and percutaneous electrical stimulation (PENS) of dermatome T6 has been demonstrated to reduce stomach motility and appetite, allowing greater weight loss than isolated hypocaloric diets. However, modulation of intestinal microbiota could improve this effect and control cardiovascular risk factors. Our objective was to test whether addition of probiotics could improve weight loss and cardiovascular risk factors in obese subjects after PENS and a hypocaloric diet. A pilot prospective study was performed in patients ( n  = 20) with a body mass index (BMI) > 30 kg/m 2 . Half of them underwent ten weeks of PENS in conjunction with a hypocaloric diet (PENS-Diet), and the other half was treated with a PENS-Diet plus multistrain probiotics ( L. plantarum LP115 ,  B. brevis B3 , and  L. acidophilus LA14 ) administration. Fecal samples were obtained before and after interventions. The weight loss and changes in blood pressure, glycemic and lipid profile, and in gut microbiota were investigated. Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet. Moreover, an enrichment of anti-obesogenic bacteria, including  Bifidobacterium spp, Akkermansia spp, Prevotella spp , and the attenuation of the Firmicutes/Bacteroidetes ratio were noted in fecal samples after probiotics administration. In obese patients, the addition of probiotics to a PENS intervention under a hypocaloric diet could further improve weight loss and glycemic and lipid profile in parallel to the amelioration of gut dysbiosis.",2020,"Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet.","['patients ( n  = 20) with a body mass index (BMI', 'obese subjects after PENS and a hypocaloric diet', 'obese patients']",['probiotics'],"['weight loss', 'glycated hemoglobin and triglycerides', 'weight loss and changes in blood pressure, glycemic and lipid profile, and in gut microbiota', 'weight loss and cardiovascular risk factors', 'weight loss and glycemic and lipid profile', 'Weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0225008,"Weight loss was significantly higher (16.2 vs. 11.1 kg,  p  = 0.022), whereas glycated hemoglobin and triglycerides were lower (-0.46 vs. -0.05%,  p  = 0.032, and -47.0 vs. -8.5 mg/dL,  p  = 0.002, respectively) in patients receiving PENS-Diet + probiotics compared with those with a PENS-Diet.","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Lorenzo', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Crespo-Yanguas', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Hang', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Jairo', 'Initials': 'J', 'LastName': 'Lumpuy-Castillo', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Artur M', 'Initials': 'AM', 'LastName': 'Hernández', 'Affiliation': 'Department of Sport Sciences, Universidad Europea de Madrid, 28670 Villaviciosa de Odón-Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Llavero', 'Affiliation': 'Obesity Unit, Clinica Garcilaso, 28010 Madrid, Spain.'}, {'ForeName': 'MLuisa', 'Initials': 'M', 'LastName': 'García-Alonso', 'Affiliation': 'Laboratory of Diabetes and Vascular Pathology, Instituto de Investigaciones Sanitarias-Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Obesity Unit, Clinica Garcilaso, 28010 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17197239']
2681,33023067,Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial.,"Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.",2020,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60).","['Indian pregnant women', 'supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg', 'Offspring Neurodevelopment at 12 Months in India', '3379 women screened, 1131 were found eligible; 957 were randomized']","['Maternal Docosahexaenoic Acid (DHA) Supplementation', 'd algal DHA', 'placebo', 'Maternal supplementation', 'dietary docosahexaenoic acid (DHA 22:6n-3']","['mean development quotient (DQ) scores', 'infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]",9.0,0.541987,"At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0,  p  = 0.60).","[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mallaiah Kenchaveeraiah', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Metgud', 'Affiliation': ""KAHER's Institute of Physiotherapy, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Jogalekar', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kamate', 'Affiliation': ""KAHER's JN Medical College, JNMC KLE University Campus, Nehru Nagar, Belgaum, Karnataka 590010, India.""}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, C-1/52, Block C 1, Bhim Nagri, Hauz Khas, New Delhi 110016, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Institutional area, Gurugram, Haryana 122003, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi 110029, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}]",Nutrients,['10.3390/nu12103041']
2682,33023132,Dietary Quality Changes According to the Preceding Maximum Weight: A Longitudinal Analysis in the PREDIMED-Plus Randomized Trial.,"One-year dietary quality change according to the preceding maximum weight in a lifestyle intervention program (PREDIMED-Plus trial, 55-75-year-old overweight or obese adults;  n  = 5695) was assessed. A validated food frequency questionnaire was used to assess dietary intake. A total of 3 groups were made according to the difference between baseline measured weight and lifetime maximum reported weight: (a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM. Data were analyzed by General Linear Model. All participants improved average lifestyle. Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns. People at maximum weight are the most benefitted in the short term by a weight management program. Long term weight loss efforts may also reduce the effect of a weight management program.",2020,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","['55-75-year-old overweight or obese adults;  n  = 5695', 'a) participants entering the study at their maximum weight, (b) moderate weight loss maintainers (WLM), and (c) large WLM']",[],"['weight and lifetime maximum reported weight', 'dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns', 'average lifestyle', 'Dietary Quality Changes']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0275905,"Participants entering the study at their maximum weight were the most susceptible to improve significantly their dietary quality, assessed by adherence to Mediterranean diet, DII and both healthful and unhealthful provegetarian patterns.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bouzas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Bibiloni', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Garcia', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mateos', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Mèdica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Bueno-Cavanillas', 'Affiliation': 'Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL-UMH, Miguel Hernández University, 46020 Alicante, Spain.'}, {'ForeName': 'Rafael M', 'Initials': 'RM', 'LastName': 'Micó-Pérez', 'Affiliation': 'Fundación Semergen, 28009 Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ortíz-Ramos', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Altés-Boronat', 'Affiliation': 'Department of Endocrinology, IDIBAPS, Hospital Clinic, University of Barcelona, 08036 Barcelona, Spain.'}, {'ForeName': 'Bogdana L', 'Initials': 'BL', 'LastName': 'Luca', 'Affiliation': 'Department of Endocrinology, Fundación Jiménez-Díaz, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Sayon-Orea', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Ignacio Manuel', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tojal-Sierra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernabé-Casanova', 'Affiliation': 'Centro Salud Raval, 03203 Elche-Alicante, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Martin-Padillo', 'Affiliation': 'Health Research Institute of the Balearic Islands (IdISBa), 07120 Palma de Mallorca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Castro-Barquero', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Fernández-García', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Cesar I', 'Initials': 'CI', 'LastName': 'Fernandez-Lazaro', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Hernández-Alonso', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saiz', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Belló-Mora', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Basterra-Gortari', 'Affiliation': 'Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}]",Nutrients,['10.3390/nu12103023']
2683,33023221,"Effect of Increasing the Dietary Protein Content of Breakfast on Subjective Appetite, Short-Term Food Intake and Diet-Induced Thermogenesis in Children.","Dietary protein affects energy balance by decreasing food intake (FI) and increasing energy expenditure through diet-induced thermogenesis (DIT) in adults. Our objective was to investigate the effects of increasing the dietary protein in an isocaloric breakfast on subjective appetite, FI, blood glucose, and DIT in 9-14 y children. Two randomized repeated measures designs were used. In experiment 1, 17 children (9 boys, 8 girls) consumed isocaloric meals (450 kcal) on four separate mornings containing: 7 g (control), 15 g (low protein, LP), 30 g (medium protein, MP) or 45 g (high protein, HP) of protein. Blood glucose and subjective appetite were measured at baseline and regular intervals for 4 h, and FI was measured at 4 h. In experiment 2, 9 children (6 boys, 3 girls) consumed the control or HP breakfast on two separate mornings, and both DIT and subjective appetite were determined over 5 h. In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05). In experiment 2, DIT was higher after HP than control ( p  < 0.05). In conclusion, increasing the dietary protein content of breakfast had favorable effects on satiety, FI, and DIT in children.",2020,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05).","['adults', '9 children (6 boys, 3 girls', '9-14', '17 children (9 boys, 8 girls', 'Children', 'y children']","['control or HP breakfast', 'Dietary Protein Content of Breakfast', 'consumed isocaloric meals']","['satiety, FI, and DIT', 'HP breakfast suppressed FI', 'subjective appetite, FI, blood glucose, and DIT', 'Blood glucose and subjective appetite', 'subjective appetite', 'DIT and subjective appetite']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0125685,"In experiment 1, all dietary protein treatments suppressed subjective appetite compared to control ( p  < 0.001), and the HP breakfast suppressed FI compared with the LP breakfast and control ( p  < 0.05).","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Fansabedian', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Vincent C H', 'Initials': 'VCH', 'LastName': 'Wong', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S-0A2, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schwartz', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Suitor', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, ON M5B-2K3, Canada.'}, {'ForeName': 'Dérick', 'Initials': 'D', 'LastName': 'Rousseau', 'Affiliation': 'Department of Chemistry & Biology, Ryerson University, Toronto, ON M5B-2K3, Canada.'}]",Nutrients,['10.3390/nu12103025']
2684,33023224,"Associations among Primary Stability, Histomorphometric Findings, and Bone Density: A Prospective Randomized Study after Alveolar Ridge Preservation with a Collagen Cone.","BACKGROUND


The objective of this investigation was to examine whether determination of bone density (BD) with a cone beam computed tomography (CBCT) scan could help predict the primary stability (PS) of the implants and to investigate whether associations between the histomorphometric findings and the CBCT scan could be observed.
MATERIALS AND METHODS


In this randomized clinical study, the efficacy of alveolar ridge preservation (ARP) with a combination of a collagen cone and a collagen membrane procedure after tooth extraction was investigated. CBCT scans were obtained after a healing period of 8 (±1) weeks. Subsequently, the CBCT scans were evaluated in terms of BD at different heights of the former socket. Eleven (±1) weeks after tooth extraction, implant placement was performed and PS was measured with resonance frequency analysis. Potential associations among the radiologically measured BD, the histomorphometric results, and the PS were analyzed.
RESULTS


No direct association was observed between the radiologically determined BD and the histomorphometric findings. No significant associations could be found between the BD and the PS.
CONCLUSION


No significant associations were observed among the BD determined by the CBCT, the histomorphometric findings, and the PS.",2020,"No significant associations were observed among the BD determined by the CBCT, the histomorphometric findings, and the PS.",[],"['cone beam computed tomography (CBCT) scan', 'Alveolar Ridge Preservation with a Collagen Cone', 'alveolar ridge preservation (ARP']","['Histomorphometric Findings, and Bone Density']",[],"[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.0453833,"No significant associations were observed among the BD determined by the CBCT, the histomorphometric findings, and the PS.","[{'ForeName': 'Sigmar', 'Initials': 'S', 'LastName': 'Schnutenhaus', 'Affiliation': 'Center of Dentistry, Dr. Schnutenhaus MVZ GmbH, 78247 Hilzingen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Götz', 'Affiliation': 'Oral Biology Laboratory, Department of Orthodontics, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, 89081 Ulm, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Rudolph', 'Affiliation': 'Center of Dentistry, Department of Prosthetic Dentistry, Ulm University, 89081 Ulm, Germany.'}, {'ForeName': 'Ralph G', 'Initials': 'RG', 'LastName': 'Luthardt', 'Affiliation': 'Center of Dentistry, Department of Prosthetic Dentistry, Ulm University, 89081 Ulm, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Edelmann', 'Affiliation': 'Center of Dentistry, Department of Prosthetic Dentistry, Ulm University, 89081 Ulm, Germany.'}]",Dentistry journal,['10.3390/dj8040112']
2685,33023276,Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women.,"BACKGROUND


Maintaining adequate hydration is important for overall health and has major implications for athletes involved in physically demanding tasks. While water is viewed as an effective means to rehydrate, and is inexpensive and readily available, electrolyte beverages appear to be more beneficial, in particular for athletes who routinely lose electrolytes through sweating. Nuun tablets contain a mix of electrolytes and are quickly dissolved in water to create an electrolyte-rich beverage. We determined the impact of Nuun tablets on the fluid balance of healthy, exercise-trained men and women at rest.
METHODS


Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs) ingested either water only or water with Nuun electrolyte tablets, at both a single and double strength concentration, in random order, on three separate occasions separated by approximately one week, in a fasted and euhydrated state. A total of 1 liter of fluid was ingested at each visit over a 30 minute period. Urine was collected from each subject at 0, 1, 2, 3, and 4 hours post-ingestion. Urine mass values were used to calculate fluid balance and the beverage hydration index (BHI; i.e., the volume of urine produced after drinking the Nuun beverages, relative to that of water only-control condition). Heart rate and blood pressure were measured throughout the four-hour period, while body weight was measured at the start and end of the experiment.
RESULTS


Neither heart rate nor blood pressure were impacted by beverage consumption. Nuun tablets resulted in a lower urine output compared to water, with fluid balances for both concentrations more favorable compared to water ( p  < 0.05), beginning at 2 h post-ingestion and continuing at the 3 h and 4 h times. Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg). The BHI was higher for Nuun (single dose in particular) compared to water at both 2 h ( p  = 0.05) and 4 h ( p  = 0.02).
CONCLUSION


The addition of Nuun electrolyte tablets to water improves the fluid balance and BHI in healthy men and women. Results were similar for both concentrations, suggesting that additional electrolytes are not necessary when in a rested state. Future studies should determine the impact of various concentrations of the Nuun beverage during physical exercise-in particular, exercise in the heat, when sweat loss may be highest.",2020,"Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg).","['healthy men and women', 'Active Men and Women', 'Eight men (25.9 ± 4.5 yrs) and 10 women (28.2 ± 9.4 yrs', 'healthy, exercise-trained men and women at rest']","['Nuun tablets', 'Nuun Electrolyte Tablets', 'ingested either water only or water with Nuun electrolyte tablets']","['Body weight loss', 'heart rate nor blood pressure', 'BHI', 'Heart rate and blood pressure', 'body weight', 'fluid balance and BHI', 'lower urine output', 'Fluid Balance']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0028961', 'cui_str': 'Oliguria'}]",,0.0942113,"Body weight loss was less with Nuun at the single dose (0.38 kg;  p  = 0.02) and double dose (0.43 kg;  p  = 0.08), compared to water (0.57 kg).","[{'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Pence', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'Center for Nutraceutical and Dietary Supplement Research, University of Memphis, 161 Roane Fieldhouse, Memphis, TN 38152, USA.'}]",Nutrients,['10.3390/nu12103030']
2686,33023357,Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials.,"Background:  The influence of comorbidities on the efficacy and safety of biologic therapies in psoriasis has not been rigorously explored. Objective:  To assess the incremental burden of comorbidities on clinical efficacy and safety of secukinumab vs etanercept and placebo among patients with plaque psoriasis pooled from 4 phase 3 trials. Methods:  Efficacy was assessed at week 12 according to achievement of Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses. Efficacy comparisons between treatment arms stratified by comorbidity status were made using logistic regression analysis with nonresponder imputation. Relationships between baseline characteristics and clinical responses were evaluated by  χ 2  tests. Results:  Of 2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity. Regardless of comorbidity status, patients receiving secukinumab were more likely to achieve PASI and IGA responses than those receiving etanercept or placebo at week 12 ( P  < .05 for all comparisons). Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( P  < .01 for all comparisons). Safety was comparable across treatment arms stratified by comorbidity. Conclusion:  Secukinumab improved clinical outcomes and was well tolerated in patients with concomitant baseline comorbid conditions.",2020,Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( P  < .01 for all comparisons).,"['patients with psoriasis and comorbidities', 'patients with plaque psoriasis pooled from 4 phase 3 trials', 'patients with concomitant baseline comorbid conditions', '2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity']","['secukinumab vs etanercept and placebo', 'placebo', 'secukinumab']","['Safety', 'likelihood of achieving PASI and IGA responses', ""Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses"", 'PASI and IGA responses', 'Body weight', 'Clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",2401.0,0.135151,Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses ( P  < .01 for all comparisons).,"[{'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, CA, United States.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Kwaku', 'Initials': 'K', 'LastName': 'Marfo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frueh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1832187']
2687,33023423,Cost-Effectiveness of Tenecteplase Before Thrombectomy for Ischemic Stroke.,"BACKGROUND AND PURPOSE


Tenecteplase improved functional outcomes and reduced the requirement for endovascular thrombectomy in ischemic stroke patients with large vessel occlusion in the EXTEND-IA TNK randomized trial. We assessed the cost-effectiveness of tenecteplase versus alteplase in this trial.
METHODS


Post hoc within-trial economic analysis included costs of index emergency department and inpatient stroke hospitalization, rehabilitation/subacute care, and rehospitalization due to stroke within 90 days. Sources for cost included key study site complemented by published literature and government websites. Quality-adjusted life-years were estimated using utility scores derived from the modified Rankin Scale score at 90 days. Long-term modeled cost-effectiveness analysis used a Markov model with 7 health states corresponding to 7 modified Rankin Scale scores. Probabilistic sensitivity analyses were performed.
RESULTS


Within the 202 patients in the randomized controlled trial, total cost was nonsignificantly lower in the tenecteplase-treated patients (40 997 Australian dollars [AUD]) compared with alteplase-treated patients (46 188 AUD) for the first 90 days( P =0.125). Tenecteplase was the dominant treatment strategy in the short term, with similar cost (5412 AUD [95% CI, -13 348 to 2523];  P =0.181) and higher benefits (0.099 quality-adjusted life-years [95% CI, 0.001-0.1967];  P =0.048), with a 97.4% probability of being cost-effective. In the long-term, tenecteplase was associated with less additional lifetime cost (96 357 versus 106 304 AUD) and greater benefits (quality-adjusted life-years, 7.77 versus 6.48), and had a 100% probability of being cost-effective. Both deterministic sensitivity analysis and probabilistic sensitivity analyses yielded similar results.
CONCLUSIONS


Both within-trial and long-term economic analyses showed that tenecteplase was highly likely to be cost-effective for patients with acute stroke before thrombectomy. Recommending the use of tenecteplase over alteplase could lead to a cost saving to the healthcare system both in the short and long term. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02388061.",2020,"P =0.181) and higher benefits (0.099 quality-adjusted life-years [95% CI, 0.001-0.1967];  P =0.048), with a 97.4% probability of being cost-effective.","['348 to 2523', '202 patients', 'ischemic stroke patients with large vessel occlusion']",[],"['cost-effectiveness', 'total cost', 'additional lifetime cost', 'Cost-Effectiveness of Tenecteplase', 'costs of index emergency department and inpatient stroke hospitalization, rehabilitation/subacute care, and rehospitalization due to stroke']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.126231,"P =0.181) and higher benefits (0.099 quality-adjusted life-years [95% CI, 0.001-0.1967];  P =0.048), with a 97.4% probability of being cost-effective.","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Deakin Health Economics, Institute of Health Transformation, School of Health and Social Development, Faculty of Health, Deakin University, Melbourne, Australia (L.G., M.M.).'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin Health Economics, Institute of Health Transformation, School of Health and Social Development, Faculty of Health, Deakin University, Melbourne, Australia (L.G., M.M.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (P.J.M.).'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine, Austin Health, University of Melbourne, Heidelberg, Australia (L.C.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (L.C., N.Y., B.Y., M.W.P., G.A.D., S.M.D., B.C.V.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.029666']
2688,33023430,NGS of microRNAs involved in cardioprotection induced by sevoflurane compared to propofol in myocardial revascularization surgery: The ACDHUVV-16 Clinical Trial.,"BACKGROUND


Numerous studies have demonstrated that halogenated agents elicit myocardial conditioning effects when adminis-tered perioperatively in cardiac surgery. Recent evidence has been published of the benefits of maintaining exposure to halogenated agents during the early postoperative period. The enzymatic mechanisms by which this beneficial effect is exerted were explained recently.
OBJECTIVES


Our study was performed to investigate whether this phenomenon is mediated by either the activation or suppression of miR-NAs targeted by halogenated anesthetics.
METHODS


A double-blind, two-stage trial was conducted. The results of the first stage of the trial are presented in this paper. The sample was composed of patients undergoing off-pump myocardial revascularization surgery. Patients were randomized to receive either sevoflu-rane [S] or propofol [P] during the intraoperative and early postoperative period (during the first six hours after the intervention). Hemody-namics (heart rate, blood pressure, central venous pressure, cardiac index, systolic volume index, LVEF) and myocardial enzymes (troponin I) were monitored at six hour intervals during the first 48 hours. In the first stage of the trial, blood was drawn for gene sequencing from eight patients (four per group) at baseline and at 24 h. In the second stage of the study, a qPCR analysis was performed of the miRNAs identified as significant by gene sequencing. Levels of cardioprotective enzymes (serine/threonine protein kinase (Akt), tumor necrosis fac-tor alpha (TNFα), extracellular regulated protein kinase (ERK 1/2), and caspase 3) were measured to assess their role in myocardial condi-tioning pathways. The purpose was to identify the miRNAs that play a major role in myocardial conditioning induced by halogenated agents. Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
RESULTS


NGS differences were observed between baseline and 24-h values in the two study groups. In group P, miRNA 197-3p was over-expressed, whereas miRNAs 4443 and 1294, 708-3p were underexpressed. In group S, miRNAs 615-3p, 4466, 29, 937-3p, 636, 197-3P, 184, 4685, 296-3p, 147b, 3199, 6815, 1294 and 3176 were underexpressed; whereas 708-3p was overexpressed. qPCR showed significant variations in miRNAs 197-3p, 4443, 708-3p and 1294 in the P group, and in miRNAs 937-3p, 636, 197-3p, 296-3p and 708-3p in the S group.
CONCLUSIONS


In the P Group, changes in the expression of some miRNAs were associated with lower concentrations of the enzymes in-volved in myocardial pre- and postconditioning. In contrast, in Group S, variations in miRNAs were associated with the activation of medi-ators of anesthetic-induced pre- and post-conditioning, a reduction in cell apoptosis, and a decrease in caspase and TnBF alpha concentra-tions. Changes in these miRNAs were associated with a better prognosis in patients with ischemic heart disease. The main limitation of this study will be overcome in the second stage of the trial, where the specific role of each miRNA will be determined.",2020,"Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
","['myocardial revascularization surgery', 'patients with ischemic heart disease', 'patients undergoing off-pump myocardial revascularization surgery']","['propofol', 'sevoflu-rane [S] or propofol [P', 'sevoflurane']","['Levels of cardioprotective enzymes (serine/threonine protein kinase (Akt), tumor necrosis fac-tor alpha (TNFα), extracellular regulated protein kinase (ERK 1/2), and caspase 3', 'Hemody-namics (heart rate, blood pressure, central venous pressure, cardiac index, systolic volume index, LVEF) and myocardial enzymes (troponin I', 'caspase and TnBF', 'Concentrations of cardioprotective enzymes']","[{'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0072402', 'cui_str': 'Protein-Serine-Threonine Kinase'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033640', 'cui_str': 'Protein kinase'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0291573', 'cui_str': 'Caspase-3'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0602839,"Concentrations of cardioprotective enzymes were higher in patients who received sevoflurane, as compared to patients who were administered propofol.
","[{'ForeName': 'Jose Luis Guerrero', 'Initials': 'JLG', 'LastName': 'Orriach', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Juan Jose Escalona', 'Initials': 'JJE', 'LastName': 'Belmonte', 'Affiliation': 'Instituto de Investigacion Biomédica de Málaga (IBIMA), Málaga,. Spain.'}, {'ForeName': 'Marta Ramirez', 'Initials': 'MR', 'LastName': 'Aliaga', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Alicia Ramirez', 'Initials': 'AR', 'LastName': 'Fernandez', 'Affiliation': 'Instituto de Investigacion Biomédica de Málaga (IBIMA), Málaga,. Spain.'}, {'ForeName': 'Maria Jose Rodriguez', 'Initials': 'MJR', 'LastName': 'Capitan', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Guillermo Quesada', 'Initials': 'GQ', 'LastName': 'Muñoz', 'Affiliation': 'Instituto de Investigacion Biomédica de Málaga (IBIMA), Málaga,. Spain.'}, {'ForeName': 'Aida Raigón', 'Initials': 'AR', 'LastName': 'Ponferrada', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Juan Alcaide', 'Initials': 'JA', 'LastName': 'Torres', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Santiago-Fernandez', 'Affiliation': 'Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Emilio Matute', 'Initials': 'EM', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Anesthesia, Hospital Universitario, Sanitas La Moraleja,. Spain.'}, {'ForeName': 'Manuel Rubio', 'Initials': 'MR', 'LastName': 'Navarro', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Bautista', 'Affiliation': 'Genómic and Ultrasecuenciation. Supercomputación y Bioinno-vación Center, Malaga University, Malaga,. Spain.'}, {'ForeName': 'Josefa Gómez', 'Initials': 'JG', 'LastName': 'Maldonado', 'Affiliation': 'Genómic and Ultrasecuenciation. Supercomputación y Bioinno-vación Center, Malaga University, Malaga,. Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Garrido-Sanchez', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición-CIBEROBN, Instituto de Salud, Carlos III,. Spain.'}, {'ForeName': 'Jose Cruz', 'Initials': 'JC', 'LastName': 'Mañas', 'Affiliation': 'Department of Cardio-Anaesthesiology, University Hospital Virgen de la Victoria, Málaga,. Spain.'}]",Current medicinal chemistry,['10.2174/0929867327999201001202607']
2689,33023473,Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study.,"BACKGROUND


PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.
METHODS


Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).
RESULTS


A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, - 7.7 days; 300 mg, - 8.2 days; placebo, - 5.6 days) was further decreased after an additional dose (100 mg, - 8.2 days; 300 mg, - 8.8 days; placebo, - 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13-24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13-24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.
CONCLUSION


Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.
TRIAL REGISTRATION


ClinicalTrials.gov (Identifier: NCT02974153 ). Registered November 23, 2016.",2020,"No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.
","['patients with chronic migraine', '1072 adults received treatment', 'adults with chronic migraine', 'mg or 300']","['eptinezumab 100\u2009mg, n\u2009=\u2009356; eptinezumab 300\u2009mg, n\u2009=\u2009350; placebo', 'eptinezumab 100\u2009mg, 300\u2009mg, or placebo', 'Eptinezumab 100', 'calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403', 'placebo', 'Eptinezumab']","['Headache Impact Test and Patient Global Impression of Change', 'efficacy and safety', 'migraine and headache endpoints', 'migraine response', 'migraine responder rates (MRRs', 'mean monthly migraine days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C4743169', 'cui_str': 'ALD403'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",1072.0,0.398382,"No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Department of Neurology, Thomas Jefferson University, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Diamond', 'Affiliation': 'Diamond Headache Clinic, Chicago, IL, USA.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Hindiyeh', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Biondi', 'Affiliation': 'Cohen Veterans Bioscience, Cambridge, MA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Woodinville, WA, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schaeffler', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01186-3']
2690,33023487,Exploring the experiences of stroke patients treated with transcranial magnetic stimulation for upper limb recovery: a qualitative study.,"BACKGROUND


Transcranial magnetic stimulation (TMS) treatments have shown promise in improving arm recovery in stroke patients. Currently, little is known about patients' experiences with repetitive TMS treatment, and this lack of knowledge may affect optimal implementation in clinical practice. The aim of this explorative study was to gain insight in the perceived effects and experiences of the design and delivery of a rTMS treatment for upper limb recovery from the perspectives of stroke patients.
METHODS


This qualitative study was conducted as part of a randomized controlled trial (RCT) in a specialized rehabilitation center. Data were collected through face-to-face semi-structured interviews with 13 stroke patients who completed a 10-day rTMS intervention for upper limb recovery. The interviews were recorded, transcribed verbatim and analyzed using thematic analysis.
RESULTS


The major themes that emerged from the patients' feedback were the following: positive experiences of the treatment (experienced physical effects, comfort, therapeutic relationship, receiving information, learning about the brain, no burden of added rTMS treatment session, no unpleasant aspects), concerns (effects of stimulation of the brain, equipment, logistics), general experience of recovery, experienced psychological effects (grateful, sense of purpose, recovery as extra motivation to exercise, disappointment and hope of group allocation), and motivation to participate (personal benefit and cognitions, altruism). Important components related to the positive experience of the design and delivery of the treatment included comfort (i.e. moment of relaxation) and the sensation of a painless treatment without side-effects. Key concerns included uncertainty and anxiety about possible negative consequences and group allocation.
CONCLUSIONS


This study demonstrates that rTMS is well accepted by stroke patients with an upper limb paresis. Besides the expectation of a therapeutic benefit, the patients reported various psychological effects. Positive experiences, such as the provision of a short moment of relaxation each day, could have practical implications for clinical stroke rehabilitation settings aimed at improving patient satisfaction. Explanation about and feedback from routine motor recovery progression monitoring at fixed times post-stroke is also valued by patients. Negative emotions may be limited or avoided by transparent and recurrent information delivery in future trials.",2020,"Positive experiences, such as the provision of a short moment of relaxation each day, could have practical implications for clinical stroke rehabilitation settings aimed at improving patient satisfaction.","['13 stroke patients who completed a', 'stroke patients', 'stroke patients with an upper limb paresis']","['10-day rTMS intervention', 'rTMS treatment', 'Transcranial magnetic stimulation (TMS', 'transcranial magnetic stimulation', 'rTMS']","['physical effects, comfort, therapeutic relationship, receiving information, learning about the brain, no burden of added rTMS treatment session, no unpleasant aspects), concerns (effects of stimulation of the brain, equipment, logistics), general experience of recovery, experienced psychological effects (grateful, sense of purpose, recovery as extra motivation to exercise, disappointment and hope of group allocation), and motivation to participate (personal benefit and cognitions, altruism']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0424089', 'cui_str': 'Sense of purpose'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0002357', 'cui_str': 'Altruism - mental defense mechanism'}]",,0.0561266,"Positive experiences, such as the provision of a short moment of relaxation each day, could have practical implications for clinical stroke rehabilitation settings aimed at improving patient satisfaction.","[{'ForeName': 'Eline Cc', 'Initials': 'EC', 'LastName': 'van Lieshout', 'Affiliation': 'Biomedical MR Imaging and Spectroscopy Group, Center for Image Sciences, University Medical Center Utrecht and Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Lilliane D', 'Initials': 'LD', 'LastName': 'Jacobs', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht and Utrecht University, and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Pelsma', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht and Utrecht University, and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Dijkhuizen', 'Affiliation': 'Biomedical MR Imaging and Spectroscopy Group, Center for Image Sciences, University Medical Center Utrecht and Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Johanna Ma', 'Initials': 'JM', 'LastName': 'Visser-Meily', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, UMC Utrecht Brain Center, University Medical Center Utrecht and Utrecht University, and De Hoogstraat Rehabilitation, Utrecht, The Netherlands. J.M.A.Visser-Meilij@umcutrecht.nl.'}]",BMC neurology,['10.1186/s12883-020-01936-5']
2691,33023488,Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis.,"BACKGROUND


In this pooled, post hoc analysis of a phase 2 trial and the phase 3 TEMSO, TOWER, and TENERE clinical trials, long-term efficacy and safety of teriflunomide were assessed in subgroups of patients with relapsing multiple sclerosis (MS) defined by prior treatment status.
METHODS


Patients were classified according to their prior treatment status in the core and core plus extension periods. In the core period, patients were grouped according to treatment status at the start of the study: treatment naive (no prior disease-modifying therapy [DMT] or DMT > 2 years prior to randomization), previously treated with another DMT (DMT > 6 to ≤24 months prior to randomization), and recently treated with another DMT (DMT ≤6 months prior to randomization). In the core plus extension period, patients were re-baselined to the time of starting teriflunomide 14 mg and grouped according to prior treatment status at that time point. Efficacy endpoints included annualized relapse rate (ARR), probability of confirmed disability worsening (CDW) over 12 weeks, and Expanded Disability Status Scale (EDSS) score. The incidence of adverse events was also assessed.
RESULTS


Most frequently received prior DMTs at baseline were glatiramer acetate and interferon beta-1a across treatment groups. Teriflunomide 14 mg significantly reduced ARR versus placebo in the core period, regardless of prior treatment status. In the core and extension periods, adjusted ARRs were low (0.193-0.284) in patients treated with teriflunomide 14 mg across all subgroups. Probability of CDW by Year 4 was similar across subgroups; by Year 5, the percentage of patients with 12-week CDW was similar in treatment-naive patients and patients recently treated with another DMT (33.9 and 33.7%, respectively). EDSS scores were stable over time in all prior-treatment subgroups. There were no new or unexpected safety signals. Limitations include selective bias due to patient attrition, variability in subgroup size, and lack of magnetic resonance imaging outcomes.
CONCLUSIONS


The efficacy and safety of teriflunomide 14 mg was similar in all patients with relapsing MS, regardless of prior treatment history.
TRIAL REGISTRATION


Phase 2 trial core: NCT01487096 ; Phase 2 trial extension: NCT00228163 ; TEMSO core: NCT00134563 ; TEMSO extension: NCT00803049 ; TOWER: NCT00751881 ; TENERE: NCT00883337 .",2020,"In the core and extension periods, adjusted ARRs were low (0.193-0.284) in patients treated with teriflunomide 14 mg across all subgroups.","['Patients were classified according to their prior treatment status in the core and core plus extension periods', 'subgroups of patients with relapsing multiple sclerosis (MS) defined by prior treatment status', 'multiple sclerosis', 'patients with relapsing MS, regardless of prior treatment history']","['treatment naive (no prior disease-modifying therapy [DMT] or DMT >\u20092\u2009years prior to randomization), previously treated with another DMT (DMT >\u20096 to ≤24\u2009months prior to randomization', 'placebo', 'Teriflunomide', 'teriflunomide']","['Probability of CDW', 'EDSS scores', 'efficacy and safety', 'adverse events', 'annualized relapse rate (ARR), probability of confirmed disability worsening (CDW) over 12\u2009weeks, and Expanded Disability Status Scale (EDSS) score', 'ARR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439230', 'cui_str': 'week'}]",,0.0374374,"In the core and extension periods, adjusted ARRs were low (0.193-0.284) in patients treated with teriflunomide 14 mg across all subgroups.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Via Olgettina 58, 20132, Milan, Italy. comi.giancarlo@hsr.it.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and The Ottawa Hospital Research Institute, 501 Smyth Rd, Box, Ottawa, ON, 601, Canada.'}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Meca-Lallana', 'Affiliation': 'National Multiple Sclerosis Reference Center (CSUR), Hospital Virgen de la Arrixaca (IMIB-Arrixaca), Ctra, Madrid-Cartagena, s/n, 30120, Murcia, Spain.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, INSERM UMR-S1172 - Lille Neuroscience et Cognition, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Byoung Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Ilwon-ro, Gangnam-gu, Seoul, South Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parajeles', 'Affiliation': 'San Juan de Dios Hospital, Paseo Colón, Merced, San José, Costa Rica.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Edwards', 'Affiliation': 'Multiple Sclerosis Center of Northeastern New York, 1182 Troy-Schenectady Rd, Ste 203, Latham, NY, 12110, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'St Josef Hospital, Ruhr University Bochum, 5092414 Gudrunstrasse 56, D-44791, Bochum, Germany.'}, {'ForeName': 'Houari', 'Initials': 'H', 'LastName': 'Korideck', 'Affiliation': 'Sanofi, 500 Kendall Street, 6th Floor, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, 500 Kendall Street, 6th Floor, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Sanofi, 500 Kendall Street, 6th Floor, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Coyle', 'Affiliation': 'Department of Neurology, Stony Brook University, HSC T12-020, Stony Brook, NY, 11794-8121, USA.'}]",BMC neurology,['10.1186/s12883-020-01937-4']
2692,33023491,The effects of neostigmine on postoperative cognitive function and inflammatory factors in elderly patients - a randomized trial.,"BACKGROUND


Postoperative cognitive dysfunction is a common postoperative complication in elderly patients. In elderly patients, the decline of organ function and neuromuscular junction function make them more sensitive to muscle relaxants. They are more likely to experience residual muscle relaxation after surgery, which may cause various adverse events. Neostigmine, a commonly used muscle relaxant antagonist, can reduce the expression of inflammatory factors, thereby reducing the pro-inflammatory response and neurodegeneration of the cerebral cortex and hippocampus after surgery. The study aimed at observing the effect of different doses of neostigmine on postoperative cognitive function and peripheral inflammatory factors in elderly patients.
METHODS


One hundred thirty-two elderly patients who underwent a radical section of gastrointestinal cancer at First Affiliated Hospital of Dalian Medical University were divided into neostigmine and saline groups at a 2:1 ratio. Neostigmine was intravenously injected in the post-anesthesia care unit (PACU) according to the train-of-four ratio (TOFR) T4/T1. When TOFR was ≤0.5, 0.04 mg/kg neostigmine was administered, whereas when TOFR was > 0.5, 0.02 mg/kg neostigmine was injected. The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery. Secondary observation indicators include the number of atropine injection, extubating time, PACU residence time, incidence of hypoxemia, hypercapnia, and postoperative nausea and vomiting in PACU, time of exhaustion, and length of hospitalization.
RESULTS


The extubating and PACU times in 0.04 mg/kg and 0.02 mg/kg groups were significantly shorter than those in the control group (P < 0.001). The incidence of early postoperative cognitive decline in 0.04 mg/kg and 0.02 mg/kg groups was 10 and 15.7%, respectively, which were significantly lower than those in the control group (P = 0.013).
CONCLUSION


In elderly patients, 0.02-0.04 mg/kg neostigmine could significantly reduce the incidence of early postoperative cognitive decline without affecting peripheral inflammatory factors.
TRIAL REGISTRATION


Trial registration: Chinese Clinical Trial Registry, ChiCTR2000031739. Registered 8 April 2020 - Retrospectively registered, http://www.medresman.org.cn .",2020,"The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery.","['elderly patients ', 'One hundred thirty-two elderly patients who underwent a radical section of gastrointestinal cancer at First Affiliated Hospital of Dalian Medical University', 'elderly patients']","['neostigmine', 'neostigmine and saline', 'Neostigmine']","['postoperative cognitive function and inflammatory factors', 'cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood', 'extubating and PACU times', 'organ function and neuromuscular junction function', 'postoperative cognitive function and peripheral inflammatory factors', 'incidence of early postoperative cognitive decline', 'number of atropine injection, extubating time, PACU residence time, incidence of hypoxemia, hypercapnia, and postoperative nausea and vomiting in PACU, time of exhaustion, and length of hospitalization']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027869', 'cui_str': 'Neuromuscular junction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4051550', 'cui_str': 'Atropine Injection'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",132.0,0.127947,"The main observation indexes were cognitive function, interleukin 1 beta (IL-1β), tumor necrosis factor-alpha (TNF-α), and interleukin 6 (IL-6) in peripheral blood at the different times before and after the surgery.","[{'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Defeng', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China. sundefengyl@163.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neuroelectrophysiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China.'}]",BMC geriatrics,['10.1186/s12877-020-01793-4']
2693,33023494,Thrombolysis implementation intervention and clinical outcome: a secondary analysis of a cluster randomized trial.,"BACKGROUND


Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the ""Thrombolysis ImPlementation in Stroke (TIPS)"" study, which aimed to improve rates of intravenous thrombolysis in Australia.
METHODS


A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0-2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5-6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups.
RESULTS


There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73-3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73-2.44) during the active-and post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56-2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61-3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active- (odds ratio: 0.53; 95% CI: 0.21-1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36-2.52).
CONCLUSION


The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage.
TRIAL REGISTRATION


Clinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796 .",2020,"The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage.
","['patients in the ""Thrombolysis ImPlementation in Stroke (TIPS)"" study']",['Thrombolysis implementation intervention'],['parenchymal haematoma'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}]",,0.110597,"The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage.
","[{'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Hasnain', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia. mdgolam.hasnain@uon.edu.au.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kerr', 'Affiliation': 'John Hunter Hospital (JHH), New Lambton Heights, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute (HMRI), New Lambton Heights, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': ""D'Este"", 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Isobel J', 'Initials': 'IJ', 'LastName': 'Hubbard', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}, {'ForeName': 'Abul Hasnat', 'Initials': 'AH', 'LastName': 'Milton', 'Affiliation': 'Epidemiology Resource Centre, Dhaka, Bangladesh.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'School of Medicine and Public Health (SMPH), University of Newcastle (UoN), Callaghan, Australia.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01705-9']
2694,33023495,Ropivacaine infiltration analgesia of the drainage exit site enhanced analgesic effects after breast Cancer surgery: a randomized controlled trial.,"BACKGROUND


Postoperative pain after breast cancer surgery remains a major challenge in patient care. Local infiltration analgesia is a standard analgesic technique used for pain relief after surgery. Its application in patients who underwent mastectomy requires more clear elucidation. This study aimed to investigate the effect of ropivacaine infiltration of drainage exit site in ameliorating the postoperative pain after mastectomy.
METHODS


A prospective randomized controlled study was conducted in 74 patients who were scheduled for unilateral mastectomy by standardized general anesthesia. Both intervention group and control group were given infiltration of the two entry points of drainage catheters with 10 ml 0.5% ropivacaine (Group A) (n = 37) or 10 ml normal saline (Group B) (n = 37). Pain scores were recorded in post-anesthesia care unit (PACU), at 6 h, 12 h, 24 h and 36 h after operation by using a visual analogue scale (VAS). Postoperative nausea and vomiting (PONV) incidence, postoperative analgesic and antiemetic requirements, the incidence of chronic pain, as well as the quality of recovery were recorded.
RESULTS


The patients in Group A showed a significant reduction in postoperative pain in PACU (p < 0.0005), at 6 h (p < 0.0005), 12 h (p < 0.0005), and 24 h after surgery (p < 0.05) when compared to those in Group B. There were more postoperative analgesic requirements in Group B (p < 0.05). With regard to the quality of recovery, Group A was shown to be much superior over Group B (p < 0.05).
CONCLUSIONS


Ropivacaine infiltration of the two drainage exit sites decreased the degree of postoperative acute pain after mastectomy, and this approach improved patients' quality of recovery.
TRIAL REGISTRATION


retrospectively registered in Chictr.org.cn registry system on 24 February 2020 ( ChiCTR2000030139 ).",2020,"The patients in Group A showed a significant reduction in postoperative pain in PACU (p < 0.0005), at 6 h (p < 0.0005), 12 h (p < 0.0005), and 24 h after surgery (p < 0.05) when compared to those in Group B.","['breast Cancer surgery', '74 patients who were scheduled for unilateral mastectomy by standardized general anesthesia', 'pain relief after surgery']","['10\u2009ml normal saline', 'Ropivacaine', 'drainage catheters with 10\u2009ml 0.5% ropivacaine', 'ropivacaine']","['postoperative analgesic requirements', 'degree of postoperative acute pain', 'postoperative pain in PACU', 'analgesic effects', ""patients' quality of recovery"", 'Pain scores', 'Postoperative nausea and vomiting (PONV) incidence, postoperative analgesic and antiemetic requirements, the incidence of chronic pain, as well as the quality of recovery']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",74.0,0.219458,"The patients in Group A showed a significant reduction in postoperative pain in PACU (p < 0.0005), at 6 h (p < 0.0005), 12 h (p < 0.0005), and 24 h after surgery (p < 0.05) when compared to those in Group B.","[{'ForeName': 'Baona', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Department of Breast Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, 518116, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. zhenghui0715@hotmail.com.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. d1974@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01175-8']
2695,33023497,Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial.,"BACKGROUND


Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients.
METHODS


The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D.
RESULTS


Home care patients (n = 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p = 0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group.
CONCLUSIONS


In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients.
TRIAL REGISTRATION


The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812 . First registration, 26 March 2015. Retrospectively registered.",2020,"Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group.","['home care patients', 'Older Patients, Clinical Trials.gov', 'older home care patients', 'general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up']",['FIMA intervention'],"['Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D', 'ADL score', 'major disease burdens and functional limitations']","[{'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0632623,"Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Auvinen', 'Affiliation': 'The East Savo Hospital District, BOX 111, FI-57101, Savonlinna, Finland. kati.auvinen@sosteri.fi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Voutilainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jyrkkä', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lönnroos', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}]",BMC geriatrics,['10.1186/s12877-020-01796-1']
2696,33023501,Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial.,"BACKGROUND


Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recruit men to weight management interventions. This paper describes patient and public involvement in pre-trial decisions relevant to recruitment and aims to report on recruitment to the subsequent men-only weight management feasibility trial, including the: i) acceptability and feasibility of recruitment; and ii) baseline sample characteristics by recruitment strategy.
METHODS


Men with BMI ≥30 kg/m 2  and/or waist circumference ≥ 40 in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas. Recruitment activities (e.g. letters sent, researcher venue hours) were recorded systematically, and baseline characteristics questionnaire data collated. Qualitative interviews (n = 50) were conducted three months post-recruitment. Analyses and reporting followed a complementary mixed methods approach.
RESULTS


105 men were recruited within four months (community n = 60, GP letter n = 45). Community outreach took 2.3 recruiter hours per participant and GP letters had an opt-in rate of 10.2% (n = 90/879). More men were interested than could be accommodated. Most participants (60%) lived in more disadvantaged areas. Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%). Recruitment strategies were acceptable, a sensitive approach and trusting relationships with recruiters valued, and the 'catchy' study name drew attention.
CONCLUSIONS


Targeted community outreach and GP letters were acceptable strategies that successfully recruited participants to a men-only weight management feasibility trial. Both strategies engaged men from disadvantaged areas, a typically underserved population. Using two recruitment strategies produced samples with different health risk profiles, which could add value to research where either primary or secondary prevention is of interest. Further work is required to examine how these strategies could be implemented and sustained in practice.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03040518 , 2nd February 2017.",2020,"Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%).","['105 men were recruited within four months (community n\u2009=\u200960, GP letter n\u2009=\u200945', 'Men with BMI ≥30\u2009kg/m 2  and/or waist circumference\u2009≥\u200940\u2009in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas']",[],['obesity-related co-morbidity'],"[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",105.0,0.158451,"Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McDonald', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UK. m.mcdonald1@postgrad.curtin.edu.au.'}, {'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Faculty of Kinesiology, University of New Brunswick, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Skinner', 'Affiliation': 'Division of Psychology, University of Stirling, Stirling, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Calveley', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carroll', 'Affiliation': ""Men's Health Forum in Ireland, Dublin, Ireland.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'School of Social and Political Sciences, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Grindle', 'Affiliation': 'Institute for Health Research and Innovation, University of the Highlands and Islands, Inverness, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Harris', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Health Informatics Centre, University of Dundee, Dundee, UK.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Hoddinott', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medical research methodology,['10.1186/s12874-020-01136-2']
2697,33023513,Long-term effects of Youth Mental Health First Aid training: randomized controlled trial with 3-year follow-up.,"BACKGROUND


Mental Health First Aid (MHFA) training teaches community members how to provide initial support to someone with a mental health problem. Key gaps in the evidence base supporting the training are the longevity of effects beyond 6 months, effects on mental health first aid behavior, and the impact of support on the recipient of aid. This study aimed to evaluate the effect of the Youth MHFA course 3 years after training.
METHODS


384 Australian parents of an adolescent aged 12-15 were randomized to receive either the 14-h Youth MHFA course or the 15-h Australian Red Cross Provide First Aid course. This paper reports outcomes at baseline and 3 years later. Primary outcomes were cases of adolescent mental health problems, and parental support towards their adolescent if they developed a mental health problem, rated by the parent and adolescent. Secondary outcomes included parent knowledge about youth mental health problems, intentions and confidence in supporting a young person, stigmatizing attitudes, and help-seeking for mental health problems. Data were analyzed with mixed-effects models with group by measurement occasion interactions.
RESULTS


3-year follow-up data was obtained from 149 parents and 118 adolescents, who were aged 16.5 years on average. Between baseline and 3-year follow-up, there was a non-significant reduction in adolescent cases of mental health problems relative to the control group (odds ratios (OR) 0.16-0.17), a non-significant improvement in parental support reported by adolescents with a mental health problem (OR 2.80-4.31), and a non-significant improvement in the quality of support that parents reported providing to their adolescents with a mental health problem (d = 0.38). Secondary outcomes that showed significant improvements relative to the control group were parental knowledge about youth mental health problems (d = 0.31) and adolescent perceptions of general social support from their parents (d = 0.35).
CONCLUSIONS


This paper reports on the longest follow-up of Mental Health First Aid training in a controlled trial. Three years after training, participants had maintained their improved knowledge about mental health problems. There were some indications of other positive effects, but the study was underpowered to clearly show benefits to mental health first aid skills and recipients of aid.
TRIAL REGISTRATION


ACTRN 12612000390886 , registered retrospectively 5/4/2012, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347502.",2020,"Between baseline and 3-year follow-up, there was a non-significant reduction in adolescent cases of mental health problems relative to the control group (odds ratios (OR) 0.16-0.17), a non-significant improvement in parental support reported by adolescents with a mental health problem (OR 2.80-4.31), and a non-significant improvement in the quality of support that parents reported providing to their adolescents with a mental health problem (d = 0.38).","['149 parents and 118 adolescents, who were aged 16.5\u2009years on average', 'Youth Mental Health First Aid training', '384 Australian parents of an adolescent aged 12-15']",['14-h Youth MHFA course or the 15-h Australian Red Cross Provide First Aid course'],"['knowledge about mental health problems', 'adolescent perceptions of general social support', 'adolescent mental health problems, and parental support towards their adolescent if they developed a mental health problem, rated by the parent and adolescent', 'parental knowledge about youth mental health problems', 'parent knowledge about youth mental health problems, intentions and confidence in supporting a young person, stigmatizing attitudes, and help-seeking for mental health problems', 'adolescent cases of mental health problems']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034907', 'cui_str': 'Red Crescent'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1319152', 'cui_str': 'Knowledge level: parenting'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.124888,"Between baseline and 3-year follow-up, there was a non-significant reduction in adolescent cases of mental health problems relative to the control group (odds ratios (OR) 0.16-0.17), a non-significant improvement in parental support reported by adolescents with a mental health problem (OR 2.80-4.31), and a non-significant improvement in the quality of support that parents reported providing to their adolescents with a mental health problem (d = 0.38).","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Morgan', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia. ajmorgan@unimelb.edu.au.'}, {'ForeName': 'Julie-Anne A', 'Initials': 'JA', 'LastName': 'Fischer', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hart', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Kelly', 'Affiliation': 'Mental Health First Aid Australia, Parkville, Australia.'}, {'ForeName': 'Betty A', 'Initials': 'BA', 'LastName': 'Kitchener', 'Affiliation': 'Mental Health First Aid Australia, Parkville, Australia.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Reavley', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia.'}, {'ForeName': 'Marie B H', 'Initials': 'MBH', 'LastName': 'Yap', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia.'}, {'ForeName': 'Anthony F', 'Initials': 'AF', 'LastName': 'Jorm', 'Affiliation': 'Centre for Mental Health, Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria, 3010, Australia.'}]",BMC psychiatry,['10.1186/s12888-020-02860-1']
2698,33023516,"Dutch women's intended participation in a risk-based breast cancer screening and prevention programme: a survey study identifying preferences, facilitators and barriers.","BACKGROUND


Risk-based breast cancer screening may improve the benefit-harm ratio of screening by tailoring policy to a woman's personal breast cancer risk. This study aims to explore Dutch women's preferences regarding the organisation and implementation of a risk-based breast cancer screening and prevention programme, identifying potential barriers and facilitators to uptake.
METHODS


A total of 5110 participants in the Dutch Personalised RISk-based MAmmography screening (PRISMA) study were invited, of whom 942 completed a two-part web-based survey. The first part contained questions about personal characteristics; for the second part, women were randomly assigned to one of four hypothetical breast cancer risk scenarios (i.e. low, average, moderate, or high) with subsequent tailored screening and prevention advice. Descriptive statistics are used to present women's organisational preferences. Univariable and multivariable logistic regression analyses were performed using seven proxy measures for acceptability of risk-based screening (e.g., interest in risk) and risk-based prevention (e.g., willingness to change diet).
RESULTS


Interest in breast cancer risk was high (80.3%). Higher assigned risk scenario was most consistently associated with acceptance of tailored screening and prevention recommendations. Increased acceptance of lifestyle changes was additionally associated with higher education. Having a first degree family history of breast cancer decreased women's motivation to participate in preventative lifestyle measures. Acceptability of medication was associated with a woman's general beliefs about the (over)use and benefit-harm balance of medication.
CONCLUSIONS


Dutch women generally appear in favour of receiving their breast cancer risk estimate with subsequent tailored screening and prevention recommendations. However, women's level of acceptance depends on their assigned risk category. Offering tailored screening and prevention recommendations to low-risk women will be most challenging. Educating women on the benefits and harms of all risk-based screening and prevention strategies is key to acceptability and informed decision-making.",2020,"Acceptability of medication was associated with a woman's general beliefs about the (over)use and benefit-harm balance of medication.
","['5110 participants in the Dutch Personalised RISk-based MAmmography screening (PRISMA) study were invited, of whom 942 completed a two-part web-based survey', ""Dutch women's"", ""woman's personal breast cancer risk""]","['hypothetical breast cancer risk scenarios (i.e. low, average, moderate, or high) with subsequent tailored screening and prevention advice', 'risk-based breast cancer screening and prevention programme', 'intended participation in a risk-based breast cancer screening and prevention programme']",['acceptance of lifestyle changes'],"[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0203028', 'cui_str': 'Screening mammography'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",5110.0,0.0192709,"Acceptability of medication was associated with a woman's general beliefs about the (over)use and benefit-harm balance of medication.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rainey', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. linda.rainey@radboudumc.nl.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'van der Waal', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Mireille J M', 'Initials': 'MJM', 'LastName': 'Broeders', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07464-2']
2699,33023521,"Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial.","BACKGROUND


The high proportion of birth weight in Ethiopia is hypothesized to be due to inadequate maternal diet which is associated with poor nutrition education during pregnancy. There was no study that evaluated the effect of nutrition education on birth weight in the study area. This study aimed to assess the effects (overall, direct and indirect effects) of guided counseling on the birth weight of neonates.
METHODS


A two-arm parallel cluster randomized controlled community trial was conducted from May 1, 2018, to April 30, 2019, in West Gojjam Zone, Northwest Ethiopia. At the baseline, 346 pregnant women in the 11 intervention clusters and 348 pregnant women in the 11 control clusters were recruited. However, birth weight was measured from 258 and 272 newborns in the intervention and control groups, respectively. In the intervention group, counseling was given monthly for four consecutive months in the participant's homes. Besides, leaflets with key counseling messages were distributed to each woman in the intervention arm. Pregnant women who attended routine nutrition education given by the health system were recruited as control. Dietary practice, nutritional status, and birth weight were the primary, secondary and tertiary outcomes of this intervention. Data were collected using a structured data collection tool. Birth weight was measured within 48 h after birth. Independent sample t-test, linear mixed-effects model, and path analysis were fitted to assess effects of the intervention.
RESULTS


The intra-cluster correlation coefficient was 0.095. The average birth weight of newborns in the intervention group was 0.257 kg higher compared with their counterparts in the control arm (β = 0.257, P < 0.001). The direct effect of this intervention on birth weight was 0.17 (β = 0.17, P<0.001 ) whereas the indirect effect of this intervention was 0.08 (β = 0.08, P<0.001 ).
CONCLUSION


Counseling using the health belief model and the theory of planned behavior has a positive effect on improving birth weight. The findings suggest the need for enhancing nutrition education of pregnant women through the application of theories to improve birth weight.
TRIAL REGISTRATION


Clinical Trials.gov NCT03627156 , ""Retrospectively registered Jun, 13, 2018"".",2020,The average birth weight of newborns in the intervention group was 0.257 kg higher compared with their counterparts in the control arm (,"['Pregnant women who attended routine nutrition education given by the health system were recruited as control', 'pregnant women', '346 pregnant women in the 11 intervention clusters and 348 pregnant women in the 11 control clusters were recruited', 'birth weight of newborns in West Gojjam Zone, Ethiopia', 'A two-arm parallel cluster randomized controlled community trial was conducted from May 1, 2018, to April 30, 2019, in West Gojjam Zone, Northwest Ethiopia']","['nutrition education', 'guided counseling']","['average birth weight of newborns', 'birth weight', 'Dietary practice, nutritional status, and birth weight', 'birth weight of neonates', 'Birth weight']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",346.0,0.0848171,The average birth weight of newborns in the intervention group was 0.257 kg higher compared with their counterparts in the control arm (,"[{'ForeName': 'Yeshalem Mulugeta', 'Initials': 'YM', 'LastName': 'Demilew', 'Affiliation': 'Department of Nutrition, School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, P.O. Box 79, Bahir Dar, Ethiopia. yeshalem_mulugeta@yahoo.com.'}, {'ForeName': 'Getu Degu', 'Initials': 'GD', 'LastName': 'Alene', 'Affiliation': 'Department of Biostatics and Epidemiology, School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, P.O. Box 79, Bahir Dar, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Public Health, Jimma University|, P.O. Box 378, Jimma, Ethiopia.'}]",BMC pediatrics,['10.1186/s12887-020-02363-8']
2700,33023530,A phase II study of daily carboplatin plus irradiation followed by durvalumab for stage III non-small cell lung cancer patients with PS 2 up to 74 years old and patients with PS 0 or 1 from 75 years: NEJ039A (trial in progress).,"BACKGROUND


Durvalumab is a standard drug used during maintenance therapy after chemoradiotherapy in patients with locally advanced non-small cell lung cancer (LA-NSCLC). However, little is known about the clinical benefits of durvalumab after chemoradiotherapy in patients with LA-NSCLC with a performance status (PS) of 2 and/or aged > 75 years. As daily carboplatin plus concurrent thoracic radiotherapy is recommended for elderly patients according to guideline, the current phase II study aims to investigate the effect of daily carboplatin plus radiotherapy followed by durvalumab for patients with stage III NSCLC who have a PS of 2 and/or are older.
METHODS


Daily carboplatin plus radiotherapy followed by durvalumab is performed for the patients with stage III NSCLC who have a PS of 2 and/or are older. This is a trial in progress manuscript.
STUDY TREATMENT


Daily, intravenous, low-dose carboplatin (30 mg/m 2  in a 30-min infusion) is administered to patients 1 h before radiotherapy for the first 20 fractions. Radiotherapy for all patients consisted of 60 Gy administered as 30 fractions over 6 weeks. Durvalumab at a dose of 10 mg/kg/body is intravenously administered every 2 weeks for up to 12 months after chemoradiotherapy.
EXPLORATORY ASSESSMENT


In the future, an exploratory investigation will be performed to determine whether the combined assessment of T-cell markers, PD-L1 expression, and tumor mutation burden could predict the outcomes of the regimen.
DISCUSSION


The results of our study will exhibit the efficacy and tolerability of durvalumab as maintenance therapy after daily carboplatin plus radiotherapy.
TRIAL REGISTRATION


During the first registration (before induction chemoradiotherapy), 70 patients will be included; then, we include 58 patients during the second registration (before durvalumab treatment after chemoradiotherapy). https://jcrb.niph.go.jp/ .
PRIMARY ENDPOINT


The primary endpoint of the current study is the 12-month progression-free survival (PFS) rate after the initiation of durvalumab.
SECONDARY ENDPOINTS


The secondary endpoints are the feasibility, objective response, PFS, overall survival, and adverse events.",2020,"The primary endpoint of the current study is the 12-month progression-free survival (PFS) rate after the initiation of durvalumab.
","['70 patients will be included; then, we include 58 patients during the second registration (before durvalumab treatment after chemoradiotherapy', 'stage III non-small cell lung cancer patients with PS 2 up to 74\u2009years old and patients with PS 0 or 1 from 75\u2009years', 'elderly patients', 'patients with stage III NSCLC who have a PS of 2 and/or are older', 'patients with LA-NSCLC with a performance status (PS) of 2 and/or aged >\u200975\u2009years', 'patients with locally advanced non-small cell lung cancer (LA-NSCLC']","['durvalumab', 'carboplatin plus radiotherapy', 'Radiotherapy', 'intravenous, low-dose carboplatin', 'carboplatin plus irradiation', 'carboplatin plus concurrent thoracic radiotherapy']","['efficacy and tolerability', 'feasibility, objective response, PFS, overall survival, and adverse events', '12-month progression-free survival (PFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",70.0,0.168049,"The primary endpoint of the current study is the 12-month progression-free survival (PFS) rate after the initiation of durvalumab.
","[{'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kaira', 'Affiliation': 'Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan. kkaira1970@yahoo.co.jp.'}, {'ForeName': 'Atsuto', 'Initials': 'A', 'LastName': 'Mouri', 'Affiliation': 'Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 732-8551, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kagamu', 'Affiliation': 'Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.'}]",BMC cancer,['10.1186/s12885-020-07406-y']
2701,33023579,Correction to: Assessing the impact of the addition of pyriproxyfen on the durability of permethrin-treated bed nets in Burkina Faso: a compound-randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['Burkina Faso'],"['permethrin-treated bed nets', 'pyriproxyfen']",[],"[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0139497', 'cui_str': 'pyriproxyfen'}]",[],,0.05123,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Kobié H', 'Initials': 'KH', 'LastName': 'Toé', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadou-gou, Burkina Faso.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mechan', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Julie-Anne A', 'Initials': 'JA', 'LastName': 'Tangena', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Morris', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Solino', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Emile F S', 'Initials': 'EFS', 'LastName': 'Tchicaya', 'Affiliation': ""Swiss Centre for Scientifc Research in Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Traoré', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadou-gou, Burkina Faso.'}, {'ForeName': 'Hanafy', 'Initials': 'H', 'LastName': 'Ismail', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maas', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Lissenden', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Durham, UK.'}, {'ForeName': 'Alfred B', 'Initials': 'AB', 'LastName': 'Tiono', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadou-gou, Burkina Faso.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Ranson', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, UK. Hilary.Ranson@lstmed.ac.uk.'}, {'ForeName': ""N'Falé"", 'Initials': 'N', 'LastName': 'Sagnon', 'Affiliation': 'Centre National de Recherche et de Formation sur le Paludisme, Ouagadou-gou, Burkina Faso.'}]",Malaria journal,['10.1186/s12936-020-03429-9']
2702,33023594,A brief intervention to reduce burnout and improve sleep quality in medical students.,"BACKGROUND


Perceived stress, burnout, and poor sleep quality are high among medical students. Interventions designed to target these issues are necessary to promote the health and well-being of medical students. The purpose of this study was twofold: 1) to assess the feasibility of implementing a sunrise alarm clock intervention with medical students and 2) to evaluate the impact of the intervention on perceived stress, burnout scores, and sleep quality.
METHODS


We conducted a feasibility study to evaluate the efficacy of a two-week, sunrise alarm clock intervention in combination with electronic device removal at bedtime. We assessed first- and second-year medical students' perceived stress, burnout scores, including Emotional Exhaustion, Depersonalization, and Low Sense of Personal Achievement, and sleep quality before and after the intervention. In addition, we measured smartphone addiction prior to the intervention.
RESULTS


A total of 57 students consented to participate, of which 55 completed both the pre- and post-assessments (3.5% attrition). The mean age of the participants was 24.8 ± 1.9 years, 50.9% (n = 29) identified as women, and 68.4% (n = 39) identified as white. Pre-intervention, 42.1% (n = 24) of students met criteria for smartphone addiction and 77.2% (n = 44) met criteria for poor sleep quality. In addition, 22.8% (n = 13) of participants had high emotional exhaustion, 64.9% (n = 31) high depersonalization, and 42.1% (n = 24) low sense of personal accomplishment prior to the intervention. Following the two-week intervention, participants showed improvements in emotional exhaustion (p = 0.001, Cohen's d = 0.353), depersonalization (p = 0.001, Cohen's d = 0.411) low sense of personal accomplishment (p = 0.023, Cohen's d = 0.275), perceived stress (p < .001, Cohen's d = .334), and sleep quality (p < 0.001, Cohen's d = 0.925). The number of participants who reported poor sleep quality decreased to 41.8% (n = 23), demonstrating a significant decline (p = 0.026). Participants also improved subjective sleep quality (p < 0.001, Cohen's d = 1.033), sleep duration (p = 0.001, Cohen's d = 0.431), sleep latency (p < 0.001, Cohen's d = 0.433), and sleep efficiency (p = 0.021, Cohen's d = 0.673).
CONCLUSIONS


These findings suggest that the two-week sunrise alarm clock protocol with electronic device removal was effective in improving sleep quality and reducing burnout scores, and perceived stress. However, additional research comparing this intervention to a proper control group is needed to draw meaningful conclusions about the effectiveness of this intervention.",2020,"Participants also improved subjective sleep quality (p < 0.001, Cohen's d = 1.033), sleep duration (p = 0.001, Cohen's d = 0.431), sleep latency (p < 0.001, Cohen's d = 0.433), and sleep efficiency (p = 0.021, Cohen's d = 0.673).
","['The mean age of the participants was 24.8\u2009±\u20091.9\u2009years, 50.9% (n\xa0=\u200929) identified as women, and 68.4% (n\xa0=\u200939) identified as white. Pre-intervention, 42.1% ', 'n\xa0=\u200924) of students met criteria for smartphone addiction and 77.2% (n\xa0=\u200944) met criteria for poor sleep quality', '57 students consented to participate, of which 55 completed both the pre- and post-assessments (3.5% attrition', 'medical students']",['sunrise alarm clock intervention'],"['personal accomplishment', 'depersonalization', 'sleep efficiency', 'subjective sleep quality', 'perceived stress, burnout scores, and sleep quality', 'sleep quality and reducing burnout scores, and perceived stress', 'perceived stress', 'sleep duration', 'sleep latency', 'stress, burnout scores, including Emotional Exhaustion, Depersonalization, and Low Sense of Personal Achievement, and sleep quality', 'emotional exhaustion', 'high emotional exhaustion', 'poor sleep quality', 'sleep quality']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",57.0,0.0432399,"Participants also improved subjective sleep quality (p < 0.001, Cohen's d = 1.033), sleep duration (p = 0.001, Cohen's d = 0.431), sleep latency (p < 0.001, Cohen's d = 0.433), and sleep efficiency (p = 0.021, Cohen's d = 0.673).
","[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Brubaker', 'Affiliation': 'Department of Medicine, Ohio University Heritage College of Osteopathic Medicine, Athens, OH, 45701, USA.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Swan', 'Affiliation': 'Department of Medicine, Ohio University Heritage College of Osteopathic Medicine, Athens, OH, 45701, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Beverly', 'Affiliation': 'Department of Primary Care, Ohio University Heritage College of Osteopathic Medicine, Athens, OH, 45701, USA. beverle1@ohio.edu.'}]",BMC medical education,['10.1186/s12909-020-02263-6']
2703,33023624,Chlorhexidine bathing of the exposed circuits in extracorporeal membrane oxygenation: an uncontrolled before-and-after study.,"BACKGROUND


Although the prevention of extracorporeal membrane oxygenation (ECMO) catheter-related infection is crucial, scientific evidence regarding best practices are still lacking.
METHODS


We conducted an uncontrolled before-and-after study to test whether the introduction of disinfection with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) of the exposed circuits and hub in patients treated with ECMO would affect the rate of blood stream infection (BSI) and microbial colonization of the ECMO catheter. We compared the microbiological and clinical data before and after the intervention.
RESULTS


A total of 1740 ECMO catheter days in 192 patients were studied. These were divided into 855 ECMO catheter days in 96 patients before and 885 ECMO catheter days in 96 patients during the intervention. The rates of BSI were significantly decreased during the intervention period at 11.7/1000 ECMO catheter days before vs. 2.3/1000 ECMO catheter days during (difference 9.4, 95% confidence interval (CI) 1.5-17.3, p = 0.019). Furthermore, the colonization of the ECMO catheter was similarly significantly reduced during the intervention period at 10.5/1000 ECMO catheter days before vs. 2.3/1000 ECMO catheter days during intervention (difference 8.3, 95% CI 0.7-15.8, p = 0.032). Hospital mortality (41.7% vs. 24%, p = 0.009) and sepsis-related death (17.7% vs. 6.3%, p = 0.014) were also significantly decreased during intervention.
CONCLUSION


Extensive disinfection of exposed ECMO circuits and hub with 2% CHG/IPA was associated with a reduction in both BSI and microbial colonization of ECMO catheters. A further randomized controlled study is required to verify these results.
TRIAL REGISTRATION


KCT 0004431.",2020,"Hospital mortality (41.7% vs. 24%, p = 0.009) and sepsis-related death (17.7% vs. 6.3%, p = 0.014) were also significantly decreased during intervention.
",['192 patients were studied'],"['extracorporeal membrane oxygenation (ECMO) catheter', 'Chlorhexidine', 'ECMO', 'disinfection with 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA']","['rate of blood stream infection (BSI) and microbial colonization of the ECMO catheter', 'colonization of the ECMO catheter', 'sepsis-related death', 'rates of BSI', 'Hospital mortality']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",192.0,0.0401235,"Hospital mortality (41.7% vs. 24%, p = 0.009) and sepsis-related death (17.7% vs. 6.3%, p = 0.014) were also significantly decreased during intervention.
","[{'ForeName': 'Hye Ju', 'Initials': 'HJ', 'LastName': 'Yeo', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Geumo-ro 20, Beomeo-ri, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 626-770, Republic of Korea.'}, {'ForeName': 'Dohyung', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Pusan National University Yangsan Hospital, Yangsan-si, South Korea.'}, {'ForeName': 'Mihyang', 'Initials': 'M', 'LastName': 'Ha', 'Affiliation': 'Interdisciplinary program of Genomic Science, Pusan National University, Yangsan-si, South Korea.'}, {'ForeName': 'Hyung Gon', 'Initials': 'HG', 'LastName': 'Je', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Pusan National University Yangsan Hospital, Yangsan-si, South Korea.'}, {'ForeName': 'Jeong Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan-si, South Korea.'}, {'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Cho', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Geumo-ro 20, Beomeo-ri, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 626-770, Republic of Korea. chowh@pusan.ac.kr.'}]","Critical care (London, England)",['10.1186/s13054-020-03310-w']
2704,33023647,"Correction to: Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['severe mental disorders in a low-income country (TaSCS'],[],[],"[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],[],,0.0598114,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. charlotte.hanlon@kcl.ac.uk.'}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia.'}, {'ForeName': 'Girmay', 'Initials': 'G', 'LastName': 'Medhin', 'Affiliation': 'Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Shibre', 'Affiliation': 'Horizon Health Network, Dr Everett Chalmers Regional Hospital, Psychiatry, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Dawit A', 'Initials': 'DA', 'LastName': 'Ejigu', 'Affiliation': ""Department of Pharmacology, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Negussie', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Wissow', 'Affiliation': 'Department of Health, Behaviour and Society, Johns Hopkins School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK.""}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA.'}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK.""}, {'ForeName': 'Abebaw', 'Initials': 'A', 'LastName': 'Fekadu', 'Affiliation': 'Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia.'}]",Trials,['10.1186/s13063-020-04776-3']
2705,33023661,Radiographic remission in rheumatoid arthritis quantified by computer-aided joint space analysis (CASJA): a post hoc analysis of the RAPID 1 trial.,"BACKGROUND


The reduction of finger joint space width (JSW) in patients with rheumatoid arthritis (RA) is strongly associated with joint destruction. Treatment with certolizumab pegol (CZP), a PEGylated anti-TNF, has been proven to be effective in RA patients. The computer-aided joint space analysis (CAJSA) provides the semiautomated measurement of joint space width at the metacarpal-phalangeal joints (MCP) based on hand radiographs. The aim of this post hoc analysis of the RAPID 1 trial was to quantify MCP joint space distance (JSD-MCP) measured by CAJSA between baseline and week 52 in RA patients treated with certolizumab pegol (CZP) plus methotrexate (MTX) compared with MTX/placebo.
METHODS


Three hundred twenty-eight patients were included in the post hoc analysis and received placebo plus MTX, CZP 200 mg plus MTX and CZP 400 mg plus MTX. All patients underwent X-rays of the hand at baseline and week 52 as well as assessment of finger joint space narrowing of the MCP using CAJSA (Version 1.3.6; Sectra; Sweden). The joint space width (JSW) was expressed as mean joint space distance of the MCP joints I to V (JSD-MCP total ).
RESULTS


The MTX group showed a significant reduction of joint space of - 4.8% (JSD-MCP total ), whereas in patients treated with CZP 200 mg/MTX and CZP 400 mg/MTX a non-significant change (JSD-MCP total  + 0.6%) was observed. Over 52 weeks, participants with DAS28 remission (DAS28 ≤ 2.6) exhibited a significant joint space increase of + 3.3% (CZP 200 mg plus MTX) and + 3.9% (CZP pegol 400 mg plus MTX).
CONCLUSION


CZP plus MTX did not reduce JSD-MCP total  estimated by CAJSA compared with MTX/placebo. Furthermore, clinical remission (DAS28 ≤ 2.6) in patients treated with CZP plus MTX was associated with an increasing JSD, indicating radiographic remission in RA.",2020,"The MTX group showed a significant reduction of joint space of - 4.8% (JSD-MCP total ), whereas in patients treated with CZP 200 mg/MTX and CZP 400 mg/MTX a non-significant change (JSD-MCP total  + 0.6%) was observed.","['patients with rheumatoid arthritis (RA', 'RA patients', 'Three hundred twenty-eight patients']","['certolizumab pegol (CZP', 'CZP pegol 400\u2009mg plus MTX', 'CZP 200\u2009mg plus MTX', 'computer-aided joint space analysis (CASJA', 'MTX', 'finger joint space width (JSW', 'PEGylated anti-TNF', 'MTX/placebo', 'placebo plus MTX, CZP 200\u2009mg plus MTX and CZP 400\u2009mg plus MTX', 'MTX and CZP', 'certolizumab pegol (CZP) plus methotrexate (MTX', 'computer-aided joint space analysis (CAJSA', 'CZP', 'CZP plus MTX']","['joint space width (JSW', 'JSD-MCP total', 'MCP joint space distance (JSD-MCP', 'joint space', 'Radiographic remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0016125', 'cui_str': 'Finger joint structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",328.0,0.163741,"The MTX group showed a significant reduction of joint space of - 4.8% (JSD-MCP total ), whereas in patients treated with CZP 200 mg/MTX and CZP 400 mg/MTX a non-significant change (JSD-MCP total  + 0.6%) was observed.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pfeil', 'Affiliation': 'Department of Internal Medicine III, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany. alexander.pfeil@med.uni-jena.de.'}, {'ForeName': 'Anica', 'Initials': 'A', 'LastName': 'Nussbaum', 'Affiliation': 'Department of Internal Medicine III, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Renz', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, Department of Pediatric Radiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Internal Medicine III, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Malich', 'Affiliation': 'Institute of Diagnostic Radiology, Suedharz-Hospital Nordhausen, Dr. Robert-Koch-Straße 38, 99734, Nordhausen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Franz', 'Affiliation': 'Department of Internal Medicine I, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oelzner', 'Affiliation': 'Department of Internal Medicine III, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Wolf', 'Affiliation': 'Department of Internal Medicine III, Jena University Hospital - Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Böttcher', 'Affiliation': 'Faculty of Medicine, Jena University Hospital - Friedrich Schiller, University Jena, Am Klinikum 1, 07747, Jena, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-020-02322-9']
2706,33023671,A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge.
TRIAL DESIGN


Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care.
PARTICIPANTS


High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1μg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs).
INTERVENTION AND COMPARATOR


This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O 2  saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition.
MAIN OUTCOMES


Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment).
RANDOMISATION


Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants).
BLINDING (MASKING)


The study is open-label, no blinding will be performed.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total number of 174 patients is required for the entire trial, n=87 per group.
TRIAL STATUS


Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3 rd  Quarter 2020 Last patient first visit (LPFV): 2 nd  Quarter 2021 Last patient last visit (LPLV): 3 rd  Quarter 2021 Trial Report completed: 4 th  Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).",2020,Lymphopenia < 0.8 x G/l and/or D-dimer,"['subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection', 'Group 3, age ≥ 50 - 75 years', '174 patients is required for the entire trial, n=87 per group', 'High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included', 'Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER', 'Quarter 2021', 'Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment']","['chemotherapy, radiotherapy, surgery', 'anti-SARS-CoV-2 convalescent plasma or standard of care', 'Requirement mechanical ventilation']","['SARS-CoV-2 viral clearance and load as well as antibody titres', 'time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital', 'Overall survival', 'Viral load, changes in antibody titers and cytokine profiles', 'Observation time', 'overall survival rate', 'overall survival', 'overall survival rates']","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.193679,Lymphopenia < 0.8 x G/l and/or D-dimer,"[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany. maike.janssen@med.uni-heidelberg.de.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schäkel', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Djuka Fokou', 'Affiliation': 'NCT-Trial Center, National Center of Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Stermann', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriegsmann', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Haberbosch', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Novotny', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vehreschild', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmitt', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Liebregts', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dreger', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hanns-Martin', 'Initials': 'HM', 'LastName': 'Lorenz', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plaszczyca', 'Affiliation': 'Department of Infectious Diseases, Molecular Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Bartenschlager', 'Affiliation': 'Department of Infectious Diseases, Molecular Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Department of Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kräusslich', 'Affiliation': 'Department of Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Halama', 'Affiliation': 'Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jäger', 'Affiliation': 'Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Leo', 'Affiliation': 'Institute for Clinical Transfusion Medicine and Cell Therapy Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Meuer', 'Affiliation': 'Institute for Clinical Transfusion Medicine and Cell Therapy Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Merle', 'Affiliation': 'Department of Internal Medicine IV, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Denkinger', 'Affiliation': 'Division of Tropical Medicine, Department of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04735-y']
2707,33023750,Bolus versus continuous feeding regimens post gastrostomy tube placement in children.,"BACKGROUND/PURPOSE


Owing to the frequency of gastrostomy tube placement in children and the numerous regimens used to start feeds after placement we attempted to see if it matters if the initial feeds after a gastrostomy tube placement are provided in a bolus or continuous manner.
METHODS


Using a prospective randomized trial, children were randomized to initial bolus or continuous chimney feeding after gastrostomy tube placement. Feeding tolerance and complications related to the gastrostomy tube were collected for 4 weeks after placement.
RESULTS


Demographics were similar in the two groups. Times to goal feeds were similar in both groups, but in the first two weeks more feeding modifications were required in the bolus group. Other than the rate of leakage during the second week after placement which occurred more in the bolus group, all other clinical outcomes were similar in the two groups.
CONCLUSIONS


Other than minor, clinically insignificant differences noted above, the method of initial feeding after a gastrostomy tube placement does not affect feeding tolerance or gastrostomy tube complication in the first month after placement.
LEVEL OF EVIDENCE


Therapeutic, level II.",2020,"Times to goal feeds were similar in both groups, but in the first two weeks more feeding modifications were required in the bolus group.",['children'],"['gastrostomy tube placement', 'continuous feeding regimens post gastrostomy tube placement', 'continuous chimney feeding after gastrostomy tube placement']","['feeding tolerance or gastrostomy tube complication', 'rate of leakage']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0744345', 'cui_str': 'Placement of gastrostomy tube'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0557689', 'cui_str': 'Chimney'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0150595', 'cui_str': 'Gastrostomy tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",,0.0294042,"Times to goal feeds were similar in both groups, but in the first two weeks more feeding modifications were required in the bolus group.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bruch', 'Affiliation': ""C. S. Mott Children's Hospital, Section of Pediatric Surgery, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109. Electronic address: sbruch@umich.edu.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paige', 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Karly', 'Initials': 'K', 'LastName': 'Saez', 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Jolly', 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Monita', 'Initials': 'M', 'LastName': 'Karmakar', 'Affiliation': ""C. S. Mott Children's Hospital, Center for Statistical Consultation and Research, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Neill"", 'Affiliation': ""C. S. Mott Children's Hospital, Clinical Nutritional Services, 1540 E. Hospital Drive, SPC 4211, Ann Arbor, MI, USA 48109.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.09.004']
2708,33023771,"Re: Hiten D. Patel, Farzana A. Faisal, Bruce J. Trock, et al. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol 2020;78:360-8.",,2020,,[],"['Radical Prostatectomy', 'Pharmacologic Prophylaxis']",['Venous Thromboembolism'],[],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0320834,,"[{'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Fankhauser', 'Affiliation': 'Department of Urology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Urology, The Christie NHS Foundation Trusts, Manchester, UK. Electronic address: christian.fankhauser@usz.ch.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Parry', 'Affiliation': 'Clinical Effectiveness Unit, Royal College of Surgeons of England, London, UK; Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Department of Urology, The Christie NHS Foundation Trusts, Manchester, UK; Department of Urology, Salford Royal NHS Foundation Trusts, Manchester, UK.'}]",European urology,['10.1016/j.eururo.2020.09.038']
2709,33023785,A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer.,"BACKGROUND


Optimal dosing of bone-targeted agents (BTAs), in patients with bone metastases remains an important clinical question. This trial compared 4-weekly versus 12-weekly therapy.
PATIENTS AND METHODS


Patients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs, were randomised 1:1 to 4-weekly or 12-weekly BTA treatment for one year. Primary end point was change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30). Secondary end points included pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs. Primary analysis was per protocol and a non-inferiority margin of 5 points was used.
RESULTS


Of 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). Using repeated-measures analysis, across all time points, patients in the 4-weekly arm had a mean HRQL-physical subdomain score which was 1.2 (95% confidence interval: -1.6 to 4.0) higher than the 12-weekly arm. The study met the definition of non-inferiority for our primary outcome. Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms. Subgroup analyses for cancer type, prior BTA use or BTA type showed no significant difference between arms.
CONCLUSION


These results in addition to those previously reported for de-escalating zoledronate and systematic reviews in both breast and prostate cancers, would support that de-escalation of commonly used BTAs is a reasonable treatment option.",2020,"Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms.","['patients with bone metastases', '263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4', 'patients with bone metastases from breast or castration-resistant prostate cancer', 'Patients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs']","['bone-targeted agents (BTAs', 'bone-targeted agents']","['mean HRQL-physical subdomain score', 'change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30', 'scores for pain, global health status, SSE rates\xa0and SSE-free survival', 'pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",263.0,0.224032,"Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stober', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ernst', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Booth', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Canil', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Blanchette', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Anil Abraham', 'Initials': 'AA', 'LastName': 'Joy', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta, T6G 1Z2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Olexiy', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Regional Cancer Care Northwest, Thunder Bay Regional Health Sciences Centre, 980 Oliver Road, Thunder Bay, Ontario, P7B 6V4, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Pond', 'Affiliation': 'Department of Oncology, McMaster University, 699 Concession Street, Suite 4-204, Hamilton, Ontario, L8V 5C2, Canada.'}, {'ForeName': 'Ahwon', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Mazzarello', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Igal', 'Initials': 'I', 'LastName': 'Kushnir', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.019']
2710,33023788,Initial Testing of a Web-Based Intervention to Reduce Adolescent Driver Inattention: A Randomized Controlled Trial.,"INTRODUCTION


Motor vehicle crashes are the leading cause of adolescent death. Inattention to the roadway contributes to crash risk. The objective of this study was to deploy an initial study of a web-based intervention (Let's Choose Ourselves) designed to improve adolescent driver attention to the roadway.
METHODS


We used a randomized controlled trial design in a sample of adolescent drivers to test if a web-based intervention decreased cell phone engagement in driving simulation at 3 months as compared with controls. As secondary hypotheses, we tested if the intervention increased the use of peer passengers to manage distractions and decreased eyes off the forward roadway in driving simulation and decreased self-reported risky driving behaviors. Adolescents, aged 16-17 years, licensed for ≤90 days were randomized to Let's Choose Ourselves with distractions in the simulator protocol at baseline, Let's Choose Ourselves with no distractions, an attention control intervention on healthy eating with distractions, or attention control with no distractions. We used Poisson regression modeling to test the primary and secondary hypotheses.
RESULTS


The trial included 60 adolescents (66.7% female, 78.3% non-Hispanic white subjects, mean age 16.8 years, licensed 50.8 days). In Poisson regression, controlling for sex, we found no significant effects of Let's Choose Ourselves on primary or secondary outcomes. However, there was a significant effect of visit on self-report outcomes, with self-reported distracted driving behaviors increasing over time.
DISCUSSION


Although there were no significant effects of Let's Choose Ourselves, self-reported risky driving behaviors increased over time. Further investigation of the relationship between driving experience and increasing inattention to the road in adolescents is warranted.",2020,"As secondary hypotheses, we tested if the intervention increased the use of peer passengers to manage distractions and decreased eyes off the forward roadway in driving simulation and decreased self-reported risky driving behaviors.","['Adolescent Driver Inattention', '60 adolescents (66.7% female, 78.3% non-Hispanic white subjects, mean age 16.8 years, licensed 50.8\xa0days', 'Adolescents, aged 16-17 years, licensed for ≤90\xa0days']",['Web-Based Intervention'],"['distracted driving behaviors', 'risky driving behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C2963175', 'cui_str': 'Driving While Distracted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.070137,"As secondary hypotheses, we tested if the intervention increased the use of peer passengers to manage distractions and decreased eyes off the forward roadway in driving simulation and decreased self-reported risky driving behaviors.","[{'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Jamison D', 'Initials': 'JD', 'LastName': 'Fargo', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swope', 'Affiliation': ''}, {'ForeName': 'Kristina B', 'Initials': 'KB', 'LastName': 'Metzger', 'Affiliation': ''}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Sommers', 'Affiliation': ''}]",Journal of emergency nursing,['10.1016/j.jen.2020.07.012']
2711,33023849,Assessment of the anterior osteotomy role in the restoration of normal pelvic floor anatomy for bladder exstrophy patients using pre and postoperative pelvic floor MRI.,"OBJECTIVE


Our aim was to evaluate the effectiveness of anterior osteotomy in the restoration of normal pelvic floor anatomy in classic bladder exstrophy repair using pelvic floor MRI as an imaging tool for evaluation.
PATIENTS AND METHODS


This study is a pilot prospective randomized controlled study that included 20 infants with classic bladder exstrophy older than three months with no history of previous surgical operations. All patients underwent complete primary repair and were randomized into two groups, with or without osteotomy. Both groups were assessed preoperatively & postoperatively after three months with pelvic floor MRI and compared to age & gender-matched control group infants with normal pelvic anatomy infants who underwent pelvic MRI for other medical conditions.
RESULTS


There was not any significant statistical difference between osteotomy and non-osteotomy groups in pre-operative demographic data and all pelvic floor MRI measurements, emphasizing that both groups were equal in all characters at the start point of the study before the operation. The mean change difference between pre-operative and post-operative pelvic floor MRI measurements were compared in both groups, and there was not any significant statistical difference in all pelvic floor MRI measurements. Both groups showed the same statistical significance when compared with the control group in all pelvic floor MRI measurements except the posterior bladder neck distance, which was in favor of the osteotomy group, closer to the normal pelvic floor anatomy.
CONCLUSIONS


Anterior osteotomy did not have a significant difference in the restoration of the normal pelvic floor anatomy when combined with complete primary repair of classic bladder exstrophy in newly diagnosed neonates older than three months, except for a single measurement, posterior bladder neck distance. Future studies needed to determine the effect of osteotomy on continence.",2020,"Both groups showed the same statistical significance when compared with the control group in all pelvic floor MRI measurements except the posterior bladder neck distance, which was in favor of the osteotomy group, closer to the normal pelvic floor anatomy.
","['All patients underwent complete primary repair', 'bladder exstrophy patients using pre and postoperative pelvic floor MRI', '20 infants with classic bladder exstrophy older than three months with no history of previous surgical operations']","['anterior osteotomy', 'pelvic MRI']","['pre-operative and post-operative pelvic floor MRI measurements', 'pelvic floor MRI measurements', 'normal pelvic floor anatomy', 'pre-operative demographic data and all pelvic floor MRI measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0005689', 'cui_str': 'Exstrophy of bladder sequence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0203201', 'cui_str': 'MRI of pelvis'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",20.0,0.0314641,"Both groups showed the same statistical significance when compared with the control group in all pelvic floor MRI measurements except the posterior bladder neck distance, which was in favor of the osteotomy group, closer to the normal pelvic floor anatomy.
","[{'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Aboul Ela', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt. Electronic address: ahmedshoukry@kasralainy.edu.eg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Zoheiry', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shouman', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Ghoneima', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Ghoneimy', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Morsi', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Seif El Deen', 'Affiliation': 'Radiology Department, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'El Fayoumy', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Lofty', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shoukry', 'Affiliation': 'Pediatric Division in Aboul Reech Hospital, Kasr Al Ainy, Cairo University, Egypt.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.09.004']
2712,33023852,Processed and Packed: How Refined Are the Foods That Children Bring to School for Snack and Lunch?,"BACKGROUND


Increasing consumption of highly processed foods has been associated with adverse health outcomes among children. In the US, children consume up to half of their daily energy intake at school.
OBJECTIVES


We sought to characterize foods that children bring from home to school according to processing level and to evaluate the effectiveness of a school-based intervention, Great Taste Less Waste (GTLW), in reducing the proportion of energy brought from highly processed foods from home compared with control.
DESIGN


Secondary data analysis of a 7-month school-based, cluster-randomized trial.
PARTICIPANTS/SETTING


Third- and fourth-grade students (n = 502, mean age: 9.0 ± 0.62 years) at 10 public elementary schools in Eastern Massachusetts (school year 2012-2013).
INTERVENTION


GTLW included a 22-lesson classroom curriculum, homework activities, monthly parent newsletters, a food shopping and packing guide for parents, food demonstrations, school-wide announcements, and a poster contest.
MAIN OUTCOME MEASURES


The energy content of foods brought to school was estimated from digital photographs, and foods were assigned to 1 of 3 processing levels (less processed or unprocessed, moderately processed, or highly processed) based on an established classification system.
STATISTICAL ANALYSES PERFORMED


The percentage of energy brought from foods categorized into each processing level was calculated and compared pre- and postintervention using hierarchical linear models.
RESULTS


Most of the food brought from home to school was highly processed (70% of food energy brought). Foods categorized as snack foods and desserts contributed the greatest percentage of total energy to the highly processed category at baseline and follow-up (72% and 69%, respectively). Energy from foods brought for snack tended to be more highly processed than those brought for lunch. No significant differences were observed from pre- to postintervention in the GTLW group compared with control for the percentage of energy brought from highly processed foods in adjusted models (β: -1.1, standard error: 2.2, P = .6) or any other processing level.
CONCLUSIONS


Highly processed foods were prevalent in home-packed lunches and snacks, and these patterns persisted after a targeted intervention. Further research is needed to identify strategies to improve the healthfulness of foods brought from home to school.",2020,"No significant differences were observed from pre- to postintervention in the GTLW group compared with control for the percentage of energy brought from highly processed foods in adjusted models (β: -1.1, standard error: 2.2, P = .6) or any other processing level.
","['children', 'Third- and fourth-grade students (n\xa0= 502, mean age: 9.0 ± 0.62 years) at 10 public elementary schools in Eastern Massachusetts (school year 2012-2013']","['Processed and Packed', 'GTLW included a 22-lesson classroom curriculum, homework activities, monthly parent newsletters, a food shopping and packing guide for parents, food demonstrations, school-wide announcements, and a poster contest']",['total energy'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0557779', 'cui_str': 'Food shop'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0376675', 'cui_str': 'Posters'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0264596,"No significant differences were observed from pre- to postintervention in the GTLW group compared with control for the percentage of energy brought from highly processed foods in adjusted models (β: -1.1, standard error: 2.2, P = .6) or any other processing level.
","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Blondin', 'Affiliation': ''}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'AlSukait', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bleiweiss-Sande', 'Affiliation': ''}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Economos', 'Affiliation': ''}, {'ForeName': 'Lindsay A', 'Initials': 'LA', 'LastName': 'Tanskey', 'Affiliation': ''}, {'ForeName': 'Jeanne P', 'Initials': 'JP', 'LastName': 'Goldberg', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.07.017']
2713,33023868,Hand-held dynamometer to measure pressure pain thresholds: A double-blinded reliability and validity study.,"BACKGROUND


Pain is the most common complaint reported in the musculoskeletal setting. Quantitative sensory testing (QST) assists with pain mechanism identification, although QST is typically performed in research settings. It is possible that clinical utilization of QST may improve if clinically accessible tools can be reliably and validly used.
OBJECTIVE


To determine if a hand-held dynamometer (HHD) can be a valid and reliable assessment of pressure pain threshold (PPT).
DESIGN


Double-blinded validation study.
METHODS


Eighteen healthy subjects (25.6 ± 3.4 years old) participated in this study. Two testers independently assessed PPT using a HHD and a digital algometer. Assessments followed previously described pressure algometry protocols. Testers and subjects were each blinded to data during assessments.
RESULTS


Intra- and inter-rater reliability were excellent for the foot and face for both devices (ICC's > 0.9). Bland-Altman plots and intraclass correlation coefficients revealed good-excellent agreement with minimal proportional bias when normalizing device force at pain threshold to the circumference of the device applicator (ICC 95%CI: 0.56-0.95). Only poor-good agreement (ICC 95% CI: 0.30-0.76) and significant proportional bias was observed when normalizing to area (pressure).
CONCLUSIONS


Based on the results of this study, when force is normalized by circumference of the applicator, a HHD was found to be a valid and reliable tool for measuring PPT. Clinicians may use HHD to detect relevant pain mechanisms at fault in their evaluation and treatment of pain. Additional research in various pathologic populations is warranted.",2020,"RESULTS


Intra- and inter-rater reliability were excellent for the foot and face for both devices (ICC's > 0.9).",['Eighteen healthy subjects (25.6\xa0±\xa03.4 years old'],"['QST', 'hand-held dynamometer (HHD', 'Quantitative sensory testing (QST']",['pressure pain thresholds'],"[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",18.0,0.129315,"RESULTS


Intra- and inter-rater reliability were excellent for the foot and face for both devices (ICC's > 0.9).","[{'ForeName': 'Dhinu J', 'Initials': 'DJ', 'LastName': 'Jayaseelan', 'Affiliation': 'The George Washington University, Department of Health, Human Function, and Rehabilitation Sciences, Washington, DC, USA. Electronic address: dhinuj@gwu.edu.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Cole', 'Affiliation': 'The George Washington University, Department of Health, Human Function, and Rehabilitation Sciences, Washington, DC, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Courtney', 'Affiliation': 'Northwestern University, Department of Physical Therapy and Human Movement Sciences, Chicago, IL, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102268']
2714,33023877,Effect of a real-time feedback smartphone application (TCPRLink) on the quality of telephone-assisted CPR performed by trained laypeople in China: a manikin-based randomised controlled study.,"OBJECTIVES


To determine the effect of a free smartphone application (TCPRLink) that provides real-time monitoring and audiovisual feedback on chest compressions (CC) on trained layperson telephone-assisted cardiopulmonary resuscitation (T-CPR) performance.
DESIGN


A manikin-based randomised controlled study.
SETTING


This study was conducted at a multidisciplinary university and a community centre in China.
PARTICIPANTS


One hundred and eighty-six adult participants (age 18-65 years) with T-CPR training experience were randomly assigned to the TCPRLink (n=94) and T-CPR (n=92) groups with age stratification.
INTERVENTIONS


We compared the participants' performance for 6 min of CC in a simulated T-CPR scenario both at the baseline and after 3 months.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes were the CC rate and proportion of adequate CC rate (100-120 min -1 ). The secondary outcomes included the proportion of participants counting the CC rhythm, time to first CC, CC depth, hands-off time and CC full-release ratio.
RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group. There were no significant differences in time to the first CC, hands-off time or CC full-release ratio. Among 55-65 year group, the CC depth was deeper in the TCPRLink group than in the TCPR group (47.1±9.6 vs 38.5±8.7 mm, p=0.001 and 44.7±10.1 vs 39.3±10.8 mm, p=0.07, respectively).
CONCLUSIONS


The TCPRLink application improved T-CPR quality in trained laypersons to provide more effective CCs and lighten the load of counting out the CC with the dispatcher in a simulated T-CPR scenario. Further investigations are required to confirm this effectiveness in real-life resuscitation attempts.",2020,"RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group.","['One hundred and eighty-six adult participants (age 18-65 years) with T-CPR training experience', 'China', 'n=94) and T-CPR (n=92) groups with age stratification', 'This study was conducted at a multidisciplinary university and a community centre in China']","['real-time feedback smartphone application (TCPRLink', 'free smartphone application (TCPRLink', 'TCPRLink feedback', 'TCPRLink', 'trained layperson telephone-assisted cardiopulmonary resuscitation', 'telephone-assisted CPR performed by trained laypeople', 'TCPR']","['CC depth', 'T-CPR quality', 'CC rate and proportion of adequate CC rate', 'time to the first CC, hands-off time or CC full-release ratio', 'proportion of participants counting the CC rhythm, time to first CC, CC depth, hands-off time and CC full-release ratio']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",186.0,0.0599795,"RESULTS


Participants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109-113) vs 108 (103-112) min -1 , p=0.002 and 111 (109-113) vs 108 (105-112) min -1 , p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group.","[{'ForeName': 'Xuejie', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University, Shanghai, China zhanglynn@sjtu.edu.cn.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Myklebust', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Tonje Soraas', 'Initials': 'TS', 'LastName': 'Birkenes', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zheng', 'Affiliation': 'Department of Global Health, School of Public Health, Peking University, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2020-038813']
2715,33023894,Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial.,"BACKGROUND AND OBJECTIVES


Endothelial dysfunction is common among patients with CKD. We tested the efficacy and safety of combination treatment with sodium nitrite and isoquercetin on biomarkers of endothelial dysfunction in patients with CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This randomized, double-blind, placebo-controlled phase 2 pilot trial enrolled 70 patients with predialysis CKD. Thirty-five were randomly assigned to combination treatment with sodium nitrite (40 mg twice daily) and isoquercetin (225 mg once daily) for 12 weeks, and 35 were randomly assigned to placebo. The primary outcome was mean change in flow-mediated vasodilation over the 12-week intervention. Secondary and safety outcomes included biomarkers of endothelial dysfunction, inflammation, and oxidative stress as well as kidney function, methemoglobin, and adverse events. Intention-to-treat analysis was conducted.
RESULTS


Baseline characteristics, including age, sex, race, cigarette smoking, history of hypertension and diabetes, use of renin-angiotensin system blockers, BP, fasting glucose, lipid profile, kidney function, urine albumin-creatinine ratio, and endothelial biomarkers, were comparable between groups. Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5). In addition, changes in biomarkers of endothelial dysfunction (vascular adhesion molecule-1, intercellular adhesion molecule-1, E-selectin, vWf, endostatin, and asymmetric dimethylarginine), inflammation (TNF- α , IL-6, C-reactive protein, IL-1 receptor antagonist, and monocyte chemoattractant protein-1), and oxidative stress (oxidized LDL and nitrotyrosines) were not significantly different between the two groups. Furthermore, changes in eGFR, urine albumin-creatinine ratio, methemoglobin, and adverse events were not significantly different between groups.
CONCLUSIONS


This randomized phase 2 pilot trial suggests that combination treatment with sodium nitrite and isoquercetin did not significantly improve flow-mediated vasodilation or other endothelial function biomarkers but also did not increase adverse events compared with placebo among patients with CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Nitrite, Isoquercetin, and Endothelial Dysfunction (NICE), NCT02552888.",2020,"Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5).","['70 patients with predialysis CKD', 'patients with CKD', 'Thirty-five', 'Patients with CKD']","['sodium nitrite and isoquercetin', 'isoquercetin', 'Sodium Nitrite and Isoquercetin', 'placebo', 'sodium nitrite']","['flow-mediated vasodilation or other endothelial function biomarkers', 'efficacy and safety', 'biomarkers of endothelial dysfunction, inflammation, and oxidative stress as well as kidney function, methemoglobin, and adverse events', 'age, sex, race, cigarette smoking, history of hypertension and diabetes, use of renin-angiotensin system blockers, BP, fasting glucose, lipid profile, kidney function, urine albumin-creatinine ratio, and endothelial biomarkers', 'endothelial dysfunction (vascular adhesion molecule-1, intercellular adhesion molecule-1, E-selectin, vWf, endostatin, and asymmetric dimethylarginine), inflammation (TNF- α , IL-6, C-reactive protein, IL-1 receptor antagonist, and monocyte chemoattractant protein-1), and oxidative stress (oxidized LDL and nitrotyrosines', 'eGFR, urine albumin-creatinine ratio, methemoglobin, and adverse events', 'endothelial dysfunction', 'mean change in flow-mediated vasodilation', 'flow-mediated vasodilation', 'Endothelial Dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0037532', 'cui_str': 'Sodium Nitrite'}, {'cui': 'C3891959', 'cui_str': 'isoquercetin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0025635', 'cui_str': 'Methemoglobin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0455271', 'cui_str': 'Urine albumin/creatinine ratio measurement'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0534628', 'cui_str': 'Endostatin'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.551589,"Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, -0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, -0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, -0.9 to 2.5).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana jchen@tulane.edu.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Bundy', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Damodar R', 'Initials': 'DR', 'LastName': 'Kumbala', 'Affiliation': 'Renal Associates of Baton Rouge, Baton Rouge, Louisiana.'}, {'ForeName': 'Shirisha', 'Initials': 'S', 'LastName': 'Bodana', 'Affiliation': 'Department of Nephrology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Sehgal', 'Initials': 'S', 'LastName': 'Chandra', 'Affiliation': 'Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana jchen@tulane.edu.'}, {'ForeName': 'Charlton C', 'Initials': 'CC', 'LastName': 'Starcke', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Schaefer', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lustigova', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mahone', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Aarti M', 'Initials': 'AM', 'LastName': 'Vadalia', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Livingston', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Obst', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana.'}, {'ForeName': 'Syed Rizwan', 'Initials': 'SR', 'LastName': 'Bokhari', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Kleinpeter', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana.'}, {'ForeName': 'Arnold B', 'Initials': 'AB', 'LastName': 'Alper', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Lukitsch', 'Affiliation': 'Department of Nephrology, Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana jchen@tulane.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Human Performance Lab, Appalachian State University, Kannapolis, North Carolina.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, Loiusiana jchen@tulane.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.02020220']
2716,33023898,Long-term metformin adherence in the Diabetes Prevention Program Outcomes Study.,"INTRODUCTION


To investigate long-term metformin adherence in the Diabetes Prevention Program Outcomes Study (DPPOS) by examining: (1) predictors of long-term adherence to study metformin and (2) whether metformin adherence was associated with incident type 2 diabetes.
RESEARCH DESIGN AND METHODS


DPPOS was an open-label continuation of the randomized clinical trial (Diabetes Prevention Program (DPP)) in which eligible participants randomized to the metformin group were offered study metformin and followed over 11 years. A brief structured adherence interview was administered semiannually. Metformin adherence was assessed by pill counts. Predictors of metformin adherence were examined in multivariate regression models. Incident diabetes associated with metformin adherence and other variables was assessed in Cox proportional hazards models.
RESULTS


Of 868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence. DPPOS cumulative adherence showed significant associations of higher adherence (≥80%) with early adherence at 3 months in DPP (p<0.001) and lower depression scores during DPPOS (p<0.001); significant differences were also seen by race/ethnicity (p<0.004). Predicting adherence by multivariate modeling showed odds of adherence significantly lower for Black participants and for participants reporting more than one barrier. Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence. Higher metformin adherence was significantly associated with a lower diabetes risk (p=0.04), even after adjustment for demographic variables, depression, and anxiety scores.
CONCLUSIONS


In this long-term diabetes prevention study, early metformin adherence and planned strategies to promote adherence improved long-term adherence over 11 years; higher adherence to metformin was related to lower diabetes incidence. Incorporating strategies to promote adherence when initially prescribing metformin and counseling to support adherence over time are warranted.",2020,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"['868 participants eligible to continue taking study metformin, 664 (76%) took at least some metformin over 11 years, with 478 of them reporting problems with adherence']","['Diabetes Prevention Program (DPP', 'metformin']","['Metformin adherence', 'Odds for adherence', 'lower diabetes risk', 'depression scores', 'demographic variables, depression, and anxiety scores']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",868.0,0.022693,Odds for adherence were significantly higher for those adherent early in DPP and those reporting at least one planned strategy to improve adherence.,"[{'ForeName': 'Elizabeth Arquin', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Tripputi', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Matulik', 'Affiliation': 'Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Medicine, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Tadros', 'Affiliation': 'Medicine, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'The Biostatistics Center, The George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA dppmail@bsc.gwu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001537']
2717,33023946,Inhibition of IL-1β by canakinumab may be effective against diverse molecular subtypes of lung cancer: an exploratory analysis of the CANTOS trial.,"In the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS), inhibition of the interleukin (IL)-1β inflammatory pathway by canakinumab has been shown to significantly reduce lung cancer incidence and mortality. Here we performed molecular characterization of CANTOS patients who developed lung cancer during the study, including circulating tumor DNA (ctDNA) and soluble inflammatory biomarker analysis. Catalogue Of Somatic Mutations In Cancer (COSMIC) database ctDNA mutations were detected in 65% (46/71) of the CANTOS lung cancer patients, with 51% (36/71) having detectable ctDNA at the time point closest to lung cancer diagnosis and 43% (29/67) having detectable ctDNA at trial randomization. Mutations commonly found in lung cancer were observed with no evidence of enrichment in any mutation following canakinumab treatment. Median time to lung cancer diagnosis in patients with (n=29) versus without (n=38) detectable COSMIC ctDNA mutations at baseline was 407 days versus 837 days (p=0.011). For serum inflammatory biomarker analysis, circulating levels of C-reactive protein (CRP), IL-6, IL-18, IL-1 receptor antagonist, tumor necrosis factor-α, leptin, adiponectin, fibrinogen, and plasminogen activator inhibitor-1 were determined. Patients with the highest level of baseline CRP or IL-6, both downstream of IL-1β signaling, trended toward a shorter time to lung cancer diagnosis. Other inflammation markers outside of the IL-1β pathway at baseline did not trend with time to lung cancer diagnosis. These results provide further evidence for the importance of IL-1β-mediated pro-tumor inflammation in lung cancer and suggest canakinumab's effect may be mediated in part by delaying disease progression of diverse molecular subtypes of lung cancer.",2020,"In Cancer (COSMIC) database ctDNA mutations were detected in 65% (46/71) of the CANTOS lung cancer patients, with 51% (36/71) having detectable ctDNA at the time point closest to lung cancer diagnosis and 43% (29/67) having detectable ctDNA at trial randomization.","['lung cancer', 'patients who developed lung cancer during the study, including circulating tumor DNA (ctDNA) and soluble inflammatory biomarker analysis']",[],"['lung cancer incidence and mortality', 'Median time to lung cancer diagnosis', 'Catalogue Of Somatic Mutations', 'serum inflammatory biomarker analysis, circulating levels of C-reactive protein (CRP), IL-6, IL-18, IL-1 receptor antagonist, tumor necrosis factor-α, leptin, adiponectin, fibrinogen, and plasminogen activator inhibitor-1']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0544886', 'cui_str': 'Somatic mutation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C1704264', 'cui_str': 'Interleukin 1 Inhibitor, Urine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}]",,0.0959713,"In Cancer (COSMIC) database ctDNA mutations were detected in 65% (46/71) of the CANTOS lung cancer patients, with 51% (36/71) having detectable ctDNA at the time point closest to lung cancer diagnosis and 43% (29/67) having detectable ctDNA at trial randomization.","[{'ForeName': 'Connie C', 'Initials': 'CC', 'LastName': 'Wong', 'Affiliation': 'Novartis Institutes for BioMedical Research connie.wong@novartis.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baum', 'Affiliation': 'Clinical, Leap Therapeutics.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Silvestro', 'Affiliation': 'Novartis Institutes for BioMedical Research.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Beste', 'Affiliation': 'Novartis Institutes for BioMedical Research.'}, {'ForeName': 'Bharani', 'Initials': 'B', 'LastName': 'Bharani-Dharan', 'Affiliation': 'Novartis Pharmaceuticals Corporation.'}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Novartis Institutes for BioMedical Research.'}, {'ForeName': 'Ying A', 'Initials': 'YA', 'LastName': 'Wang', 'Affiliation': 'Oncology Precision Medicine, Bayer Pharmaceuticals.'}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'IQVIA (India).'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Cardiovascular-Renal-Metabolism Clinical Development, Novartis Pharmaceuticals Corporation.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Krajkovich', 'Affiliation': 'Novartis Pharmaceuticals Corporation.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Dugan', 'Affiliation': 'Novartis Pharmaceuticals Corporation.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Martin', 'Affiliation': 'Novartis Institutes for BioMedical Research.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Svensson', 'Affiliation': 'Novartis Institutes for BioMedical Research.'}]",Cancer research,['10.1158/0008-5472.CAN-19-3176']
2718,33023958,Correspondence on 'Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis'.,,2020,,['active lupus nephritis'],"['mycophenolate mofetil', 'tacrolimus']",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],,0.0973983,,"[{'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, Allergy and Immunology, Tan Tock Seng Hospital, Singapore xuchuanhui2008@gmail.com.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219056']
2719,33023962,Response to: 'Correspondence on 'Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis'' by Xu.,,2020,,['active lupus nephritis'],['tacrolimus with mycophenolate mofetil'],[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]",[],,0.0856954,,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, China ccmok2005@yahoo.com.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219087']
2720,33023997,Electronic Medical Record-Based Pager Notification Reduces Excess Oxygen Exposure in Mechanically Ventilated Subjects.,"BACKGROUND


Liberal oxygenation during mechanical ventilation is harmful in critically ill patients and in certain subsets of patients, including those with stroke, acute myocardial infarction, and cardiac arrest. Surveillance through electronic medical records improves safety of mechanical ventilation in the ICU. To date, this practice has not been used for oxygen titration (F IO 2  ) in adults. We hypothesize that a surveillance system based on the electronic medical record to alert respiratory therapists to titrate F IO 2  is feasible, safe, and efficacious.
METHODS


In this pilot study, mechanically ventilated subjects were randomized to respiratory therapist-driven F IO 2  titration after an electronic alert versus standard of care (ie, titration based on physician order). An automated surveillance system utilizing a hyperoxemia-detection algorithm generated an electronic alert to a respiratory therapist's pager. Hyperoxemia was defined as F IO 2  > 0.5 and S pO 2  > 95% for > 30 min. No other aspects of treatment were changed. We assessed feasibility, safety, and preliminary efficacy. Primary outcome was duration of hyperoxemia during mechanical ventilation. An unsafe outcome was identified as hypoxemia (S pO 2  < 88%) within 1 h after titration per alert. Feasibility was assessed by a survey of respiratory therapists.
RESULTS


Of 226 randomized subjects, 31 were excluded (eg, programming errors of the electronic alerts, no consent, physician discretion). We included 195 subjects, of whom 86 were in the intervention arm. Alert accuracy was 78%, and respiratory therapists responded to 64% of the alerts. During mechanical ventilation, exposure to hyperoxemia significantly decreased in the intervention group (median 13.5 h [interquartile range 6.2-29.4] vs 18.8 h [interquartile range 9.6-37.4]). No episodes of significant hypoxemia were registered. Most respiratory therapists agreed that the alert was helpful in reducing excessive oxygen exposure.
CONCLUSIONS


Use of an electronic surveillance system to titrate F IO 2  was safe and feasible and showed preliminary efficacy in reducing hyperoxemia. Our study serves to justify larger randomized controlled trials for F IO 2  titration.",2020,"During mechanical ventilation, exposure to hyperoxemia significantly decreased in the intervention group (median 13.5 h [interquartile range 6.2-29.4] vs 18.8 h [interquartile range 9.6-37.4]).","['Mechanically Ventilated Subjects', 'mechanically ventilated subjects', '195 subjects, of whom 86 were in the intervention arm', '226 randomized subjects, 31 were excluded (eg']","['respiratory therapist-driven F IO 2  titration after an electronic alert versus standard of care (ie, titration based on physician order', 'Electronic Medical Record-Based Pager Notification']","['Alert accuracy', 'excessive oxygen exposure', 'duration of hyperoxemia during mechanical ventilation', 'safety of mechanical ventilation', 'Hyperoxemia']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1709924', 'cui_str': 'Respiratory therapist'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C1550704', 'cui_str': 'Pager'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",226.0,0.168628,"During mechanical ventilation, exposure to hyperoxemia significantly decreased in the intervention group (median 13.5 h [interquartile range 6.2-29.4] vs 18.8 h [interquartile range 9.6-37.4]).","[{'ForeName': 'Sonal R', 'Initials': 'SR', 'LastName': 'Pannu', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care & Sleep Medicine, The Ohio State University, Columbus, Ohio. sonal.pannu@osumc.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Holets', 'Affiliation': 'Mayo Clinic, Department of Respiratory Care, Rochester, Minnesota.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Mayo Clinic, Department of Information Technology, Rochester, Minnesota.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marquez', 'Affiliation': 'Mayo Clinic, Department of Respiratory Care, Rochester, Minnesota.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Mayo Clinic, Department of Anesthesiology, Division of Critical Care Medicine, Rochester, Minnesota.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brock', 'Affiliation': 'Center for Biostatistics and Bioinformatics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': 'Department of Pulmonary and Division of Critical Care Medicine, Mayo Clinic, Rochester, Minnesota.'}]",Respiratory care,['10.4187/respcare.07573']
2721,33024002,Acute Effects of Lung Expansion Maneuvers in Comatose Subjects With Prolonged Bed Rest.,"BACKGROUND


Patients with decreased consciousness are prone to prolonged bed rest and respiratory complications. If effective in reducing atelectasis, lung expansion maneuvers could be used to prevent these complications. In comatose, bedridden subjects, we aimed to assess the acute effect on regional lung aeration of 2 lung expansion techniques: expiratory positive airway pressure and the breath-stacking maneuver. Our secondary aim was to evaluate the influence of these lung expansion techniques on regional ventilation distribution, regional ventilation kinetics, respiratory pattern, and cardiovascular system.
METHODS


We enrolled 10 subjects status post neurosurgery, unable to follow commands, and with prolonged bed rest. All subjects were submitted to both expansion techniques in a randomized order. Regional lung aeration, ventilation distribution, and regional ventilation kinetics were measured with electrical impedance tomography.
RESULTS


Lung aeration increased significantly during the application of both expiratory positive airway pressure and breath-stacking ( P  < .001) but returned to baseline values seconds afterwards. The posterior lung regions had the largest volume increase ( P  < .001 for groups). Both maneuvers induced asynchronous inflation and deflation between anterior and posterior lung regions. There were no significant differences in cardiovascular variables.
CONCLUSIONS


In comatose subjects with prolonged bed rest, expiratory positive airway pressure and breath-stacking promoted brief increases in lung aeration. (ClinicalTrials.gov registration NCT02613832.).",2020,"RESULTS


Lung aeration increased significantly during the application of both expiratory positive airway pressure and breath-stacking ( P  < .001) but returned to baseline values seconds afterwards.","['Comatose Subjects With Prolonged Bed Rest', '10 subjects status post neurosurgery, unable to follow commands, and with prolonged bed rest']",['Lung Expansion Maneuvers'],"['cardiovascular variables', 'Regional lung aeration, ventilation distribution, and regional ventilation kinetics', 'lung aeration', 'regional ventilation distribution, regional ventilation kinetics, respiratory pattern, and cardiovascular system', 'expiratory positive airway pressure and breath-stacking']","[{'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C1710178', 'cui_str': 'Breath stacking'}]",10.0,0.0693922,"RESULTS


Lung aeration increased significantly during the application of both expiratory positive airway pressure and breath-stacking ( P  < .001) but returned to baseline values seconds afterwards.","[{'ForeName': 'Caio Ca', 'Initials': 'CC', 'LastName': 'Morais', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Shirley L', 'Initials': 'SL', 'LastName': 'Campos', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Catarina Sfr', 'Initials': 'CS', 'LastName': 'Lima', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Lucas Jf', 'Initials': 'LJ', 'LastName': 'Monte', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'de Pontes Bandeira', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Daniella C', 'Initials': 'DC', 'LastName': 'Brandão', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Eduardo Lv', 'Initials': 'EL', 'LastName': 'Costa', 'Affiliation': 'Instituto de Ensino e Pesquisa do Hospital Sírio Libanês, São Paulo, Brazil and Division of Pulmonology, Heart Institute, Hospital das Clinicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Aliverti', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italia.'}, {'ForeName': 'Marcelo Bp', 'Initials': 'MB', 'LastName': 'Amato', 'Affiliation': 'Division of Pulmonology, Heart Institute, Hospital das Clinicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Armèle Dornelas', 'Initials': 'AD', 'LastName': 'de Andrade', 'Affiliation': 'Physiotherapy Department, Universidade Federal de Pernambuco, Recife, Brazil. armeledornelas@yahoo.com armele.andrade@ufpe.br.'}]",Respiratory care,['10.4187/respcare.07535']
2722,33024022,Treatment response score to glatiramer acetate or interferon beta-1a.,"OBJECTIVE


To compare the effectiveness of glatiramer acetate (GA) vs intra-muscular Interferon beta-1a (IFNbeta-1a)), we applied a previously published statistical method, aimed at identifying patients' profiles associated with efficacy of treatments.
METHODS


Data from 2 independent multiple sclerosis datasets, a randomized study (the CombiRx trial, evaluating GA vs IFNbeta-1a and an observational cohort extracted from MSBase, were used to build and validate a treatment response score, regressing annualized relapse rates (ARRs) on a set of baseline predictors.
RESULTS


The overall ARR ratio of GA vs IFNbeta-1a in the CombiRx trial was 0.72. The response score (made up of a linear combination of age, sex, relapses in the previous year, disease duration and EDSS) detected differential response of GA vs IFNbeta-1a: in the trial, patients with the largest benefit from GA vs IFNbeta-1a (lower score quartile) had an ARR ratio of 0.40 (95%confidence interval [CI] = 0.25-0.63), those in the 2 middle quartiles of 0.90 (95% CI = 0.61-1.34) and those in the upper quartile of 1.14 (95%CI = 0.59-2.18) (heterogeneity  p  = 0.012); this result was validated on MSbase, with the corresponding ARR ratios of 0.58 (95% CI = 0.46-0.72), 0.92 (95% CI = 0.77-1.09) and 1.29 (95% CI = 0.97-1.71); heterogeneity  p  < 0.0001).
CONCLUSIONS


We demonstrate the possibility of a criterion, based on patients' characteristics, to choose whether to treat with GA or IFNbeta-1a. This result, replicated on an independent real-life cohort, may have implications for clinical decisions in everyday clinical practice.",2020,"RESULTS


The overall ARR ratio of GA vs IFNbeta-1a in the CombiRx trial was 0.72.",['Data from 2 independent multiple sclerosis datasets'],"['glatiramer acetate (GA) vs intra-muscular Interferon beta-1a (IFNbeta-1a', 'glatiramer acetate or interferon beta-1a']","['overall ARR ratio of GA', 'ARR ratio', 'response score']","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.228919,"RESULTS


The overall ARR ratio of GA vs IFNbeta-1a in the CombiRx trial was 0.72.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bovis', 'Affiliation': 'From the Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kalincik', 'Affiliation': 'CORe, Department of Medicine, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Lublin', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Malpas', 'Affiliation': 'CORe, Department of Medicine, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Horakova', 'Affiliation': 'Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Eva Kubala', 'Initials': 'EK', 'LastName': 'Havrdova', 'Affiliation': 'Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trojano', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, Université de Montréal, Montréal, QC Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, Université de Montréal, Montréal, QC Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duquette', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, Université de Montréal, Montréal, QC Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Onofrj', 'Affiliation': ""Department of Neuroscience, Imaging, and Clinical Sciences, University G. d'Annunzio, Chieti, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lugaresi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Izquierdo', 'Affiliation': 'Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical, Surgical Science and Advanced Technology ""GF Ingrassia"", University of Catania, Catania, Italy.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Terzi', 'Affiliation': 'Ondokuz Mayis University, Department of Neurology, Samsun, Turkey.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Grammond', 'Affiliation': ""CISSS Chaudi're-Appalache, Centre-Hospitalier, Levis, Canada.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bergamaschi', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Sola', 'Affiliation': 'Department of Neuroscience, Azienda Ospedaliera Universitaria, Modena, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ferraro', 'Affiliation': 'Department of Neuroscience, Azienda Ospedaliera Universitaria, Modena, Italy.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Ozakbas', 'Affiliation': 'Dokuz Eylul University, Department of Neurology, Izmir, Turkey.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Iuliano', 'Affiliation': 'Ospedali Riuniti di Salerno, Salerno, Italy.'}, {'ForeName': 'Cavit', 'Initials': 'C', 'LastName': 'Boz', 'Affiliation': 'Karadeniz Technical University, Department of Neurology, 61080, Trabzon, Turkey.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hupperts', 'Affiliation': 'Department of Neurology, Zuyderland Medical Center, Sittard, Netherlands.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': ""Grand'Maison"", 'Affiliation': 'Neuro Rive-Sud, Hôpital Charles LeMoyne, Greenfield Park, Quebec, Canada.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Oreja-Guevara', 'Affiliation': 'Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van Pesch', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Cartechini', 'Affiliation': 'UOC Neurologia, Azienda Sanitaria Unica Regionale Marche - AV3, Macerata, Italy.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Petersen', 'Affiliation': 'Kommunehospitalet, Arhus C, Denmark.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Altintas', 'Affiliation': 'Koc University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Soysal', 'Affiliation': 'Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases, Istanbul, Turkey.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ramo-Tello', 'Affiliation': 'Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'McCombe', 'Affiliation': 'University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Recai', 'Initials': 'R', 'LastName': 'Turkoglu', 'Affiliation': 'Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Solaro', 'Affiliation': 'Rehabilitation Unit, ""Mons. L. Novarese"" Hospital,Moncrivello, VC, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'From the Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy; mariapia.sormani@unige.it.'}]",Neurology,['10.1212/WNL.0000000000010991']
2723,33024120,Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study).,"Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], -1.04[-1.19, -0.89]%) and BBR-alone group (-0.99[-1.16, -0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (-0.59[-0.75, -0.44]%, -0.53[-0.68, -0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).",2020,BBR treatment induced more gastrointestinal side effects.,"['Four-hundred-nine eligible participants', 'newly diagnosed T2D patients from 20 centres in China']","['BBR-alone, probiotics+BBR, probiotics-alone, or placebo', 'berberine and probiotics', 'placebo', 'BBR']","['gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis', 'gastrointestinal side effects', 'glycated haemoglobin']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",409.0,0.295139,BBR treatment induced more gastrointestinal side effects.,"[{'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huahui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Huanzi', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xuejiang', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'The First Affiliated hospital of Wenzhou Medical University, Zhejiang Province, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangdong Province, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Tong Ren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Central Hospital of Minhang District, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Qilu Hospital of Shandong University, Shandong Province, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fujian Provincial Hospital, Fujian Province, China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ""Shanghai Tenth People's Hospital of Tong Ji University, Shanghai, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Xuzhou Central Hospital, Jiangsu Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Chang Hai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""Shanghai First People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guixue', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Zhun', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Huanming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China.'}, {'ForeName': 'Guowang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Dalian Institute of Chemical Physics, Chinese Academy of Science, Dalian, Liaoning Province, China.'}, {'ForeName': 'Shenghan', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'BGI-Shenzhen, Shenzhen, 518083, China. lijunhua@genomics.cn.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. wqingw61@163.com.'}]",Nature communications,['10.1038/s41467-020-18414-8']
2724,33024123,Metastable hybridization-based DNA information storage to allow rapid and permanent erasure.,"The potential of DNA as an information storage medium is rapidly growing due to advances in DNA synthesis and sequencing. However, the chemical stability of DNA challenges the complete erasure of information encoded in DNA sequences. Here, we encode information in a DNA information solution, a mixture of true message- and false message-encoded oligonucleotides, and enables rapid and permanent erasure of information. True messages are differentiated by their hybridization to a ""truth marker"" oligonucleotide, and only true messages can be read; binding of the truth marker can be effectively randomized even with a brief exposure to the elevated temperature. We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C. Heating to 95 °C for 5 minutes, however, permanently erases the message.",2020,"We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C.",[],[],[],[],[],[],,0.0718338,"We show 8 separate bitmap images can be stably encoded and read after storage at 25 °C for 65 days with an average of over 99% correct information recall, which extrapolates to a half-life of over 15 years at 25 °C.","[{'ForeName': 'Jangwon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA.'}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baym', 'Affiliation': 'Department of Biomedical Informatics, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'David Yu', 'Initials': 'DY', 'LastName': 'Zhang', 'Affiliation': 'Department of Bioengineering, Rice University, Houston, TX, 77030, USA. dyz1@rice.edu.'}]",Nature communications,['10.1038/s41467-020-18842-6']
2725,33024237,The effect of aldosterone and aldosterone blockade on the progression of chronic kidney disease: a randomized placebo-controlled clinical trial.,"The progression of chronic kidney disease (CKD) cannot be completely inhibited. We first explored factors contributing to CKD progression in patients with CKD in a prospective observational study. In the next phase, we focused on the effects of aldosterone, conducting a single-blinded placebo-controlled study using the selective mineralocorticoid receptor antagonist (MRA), eplerenone (25 mg/day). We recruited patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15 ng/dL based on the prior data of a prospective observational study. In the CKD cohort study (n = 141), baseline plasma aldosterone concentration was identified as an independent contributory factor for the future rate of change in estimated glomerular filtration rate (eGFR). When the cut-off value for aldosterone was set at 14.5 ng/dL, the decline rate was significantly higher in patients with higher plasma aldosterone concentration (- 1.22 ± 0.39 ml/min/1.73 m 2 /year vs. 0.39 ± 0.40 ml/min/1.73 m 2 /year, p = 0.0047). In the final intervention study, in the eplerenone group, eGFR dropped at 6 months after the initiation of the study, and thereafter eGFR was maintained until the end of the study. At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group. In conclusion, MRA can be an effective strategy in preventing CKD progression, especially in patients with high plasma aldosterone.",2020,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","['patients with CKD', 'patients with CKD stage 2 and 3 whose plasma aldosterone concentration was above 15\xa0ng/dL based on the prior data of a prospective observational study', 'patients with high plasma aldosterone', 'chronic kidney disease']","['aldosterone', 'MRA', 'eplerenone', 'placebo', 'aldosterone and aldosterone blockade', 'selective mineralocorticoid receptor antagonist (MRA), eplerenone']","['progression of chronic kidney disease (CKD', 'baseline plasma aldosterone concentration', 'eGFR', 'decline rate', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0289782,"At 24 months and 36 months, eGFR was significantly higher in the eplerenone group than in the placebo group.","[{'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minakuchi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wakino', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. shuwakino@z8.keio.jp.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Urai', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Kurokochi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hirobumi', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}]",Scientific reports,['10.1038/s41598-020-73638-4']
2726,33024260,Does crossover treatment of control subjects invalidate results of randomized trials of patent ductus arteriosus treatment?,"Optimal management of patent ductus arteriosus (PDA) in extremely preterm infants remains controversial. There is paucity of evidence on the benefits of PDA treatment in reducing mortality and morbidities in extremely preterm infants. Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects. This perspective examines the PDA treatment trials to date, with specific focus on rates of and ages of subjects at open rescue treatment. Although these trials demonstrate that ductal closure is significantly increased with treatment, that does not translate to a significant decrease in major morbidities or mortality in premature infants, even when trials with high rates of rescue treatment of controls are excluded. Trials in which enrollment occurred after 7 days of age include insufficient numbers of subjects to evaluate this relationship.",2020,Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects.,"['extremely preterm infants', 'premature infants']","['patent ductus arteriosus (PDA', 'patent ductus arteriosus treatment', 'PDA']","['major morbidities or mortality', 'mortality and morbidities']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0459007,Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects.,"[{'ForeName': 'Meera N', 'Initials': 'MN', 'LastName': 'Sankar', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA. mnsankar@stanford.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Benitz', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00848-z']
2727,33024268,Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO.,"BACKGROUND


FOLFOXIRI/bevacizumab (bev) is a first-line regimen of proven activity and efficacy in metastatic colorectal cancer. The upfront exposure to three cytotoxics raises concerns about the efficacy of treatments after progression.
METHODS


We performed a pooled analysis of treatments after progression to upfront FOLFOXIRI/bev in patients enrolled in two randomised Phase 3 studies (TRIBE and TRIBE2) that compared FOLFOXIRI/bev to doublets (FOLFOX or FOLFIRI)/bev. Response rate, progression-free survival (2nd PFS) and overall survival (2nd OS) during treatments after progression were assessed. The RECIST response in first line and the oxaliplatin and irinotecan-free interval (OIFI) were investigated as potential predictors of benefit from FOLFOXIRI ± bev reintroduction.
RESULTS


Longer 2nd PFS was reported in patients receiving FOLFOXIRI ± bev reintroduction compared to doublets ± bev or other treatments (6.1 versus 4.4 and 3.9 months, respectively, P = 0.013), and seems limited to patients achieving a response during first line (6.9 versus 4.2 and 4.7 months, respectively, P = 0.005) and an OIFI ≥ 4 months (7.2 versus 6.5 and 4.6 months, respectively, P = 0.045).
CONCLUSIONS


First-line FOLFOXIRI/bev does not impair the administration of effective second-line therapies. First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.",2020,"First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.",['metastatic colorectal cancer'],"['oxaliplatin and irinotecan', 'FOLFOXIRI/bev to doublets (FOLFOX or FOLFIRI)/bev', 'bevacizumab']","['Response rate, progression-free survival (2nd PFS) and overall survival (2nd OS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.026285,"First-line response and longer OIFI seem associated with improved response and 2nd PFS from FOLFOXIRI ± bev reintroduction, without impacting 2nd OS.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Unit of Medical Oncology 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology, IOV - IRCSS, Via Gattamelata 64, 35128, Padova, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, Campus Bio-Medico-University of Rome, Via Álvaro del Portillo 200, 00128, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Oncology Unit, Oncology Department, ASST of Cremona, Viale Concordia 1, 26100, Cremona, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ermacora', 'Affiliation': 'Department of Oncology, ASUFC University Hospital, Udine, Via Pozzuolo 330, 33100, Udine, Italy.'}, {'ForeName': 'Marco Maria', 'Initials': 'MM', 'LastName': 'Germani', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Unit of Medical Oncology 1, Department of Clinical and Experimental Oncology, Veneto Institute of Oncology, IOV - IRCSS, Via Gattamelata 64, 35128, Padova, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ricci', 'Affiliation': 'Medical Oncology and Laboratory of Translational Oncology, Oncology Department, S. Croce and Carle Teaching Hospital Cuneo, Via Michele Coppino 26, 12100, Cuneo, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Caponnetto', 'Affiliation': 'Department of Radiological Science, Oncology And Pathology, Policlinico Umberto I, ""Sapienza"" University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moretto', 'Affiliation': 'Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Poliambulanza Foundation, Via Bissolati 57, 25124, Brescia, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Department, Fondazione IRCSS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Department of Clinical Oncology, Centro di Riferimento Oncologico (CRO) IRCCS, Via Franco Gallini 2, 33081, Aviano, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Ritorto', 'Affiliation': 'Ssd Colorectal Cancer Unit Dipartimento Di Oncologia, AOU Città della Salute e della Scienza di Torino, Corso Bramante 88, 10126, Turin, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Oncology Unit, IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 1, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Rapisardi', 'Affiliation': 'Oncology Unit, ARNAS Garibaldi Catania, Piazza Santa Maria di Gesù 5, 95100, Catania, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. chiaracremolini@gmail.com.'}]",British journal of cancer,['10.1038/s41416-020-01089-9']
2728,33024271,Correlative serum biomarker analyses in the phase 2 trial of lenvatinib-plus-everolimus in patients with metastatic renal cell carcinoma.,"BACKGROUND


No biomarkers have been established to predict treatment efficacy in renal cell carcinoma (RCC). In an exploratory retrospective analysis of a Phase 2 study, we constructed composite biomarker scores (CBSs) to predict progression-free survival (PFS) and overall survival (OS) in patients with metastatic RCC randomised to receive lenvatinib-plus-everolimus.
METHODS


Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively. A 2-factor CBS was generated with biomarkers common to PFS-CBS and OS-CBS. Patients were divided into groups accordingly (5-factor-CBS high: 3-5, CBS-low: 0-2; 2-factor-CBS high: 1-2, CBS-low: 0).
RESULTS


PFS/OS with lenvatinib-plus-everolimus were significantly longer in the 5-factor CBS-high group versus the CBS-low group (P = 0.0022/P < 0.0001, respectively). In the CBS-high group, PFS/OS were significantly longer with lenvatinib-plus-everolimus versus everolimus (P < 0.001/P = 0.0079, respectively); PFS was also significantly longer with lenvatinib-plus-everolimus versus lenvatinib (P = 0.0046). The 5-factor-CBS had a predictive role in PFS and OS after multivariate analysis. Similar trends were observed with the 2-factor-CBS for PFS (i.e., lenvatinib-plus-everolimus versus everolimus).
CONCLUSIONS


The 5-factor CBS may identify patients with metastatic RCC who would benefit from lenvatinib-plus-everolimus versus everolimus; additional validation is required.
CLINICAL TRIAL REGISTRATION


The clinical trial registration number is NCT01136733.",2020,"METHODS


Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively.","['patients with metastatic RCC randomised to receive', 'patients with metastatic renal cell carcinoma', 'renal cell carcinoma (RCC', 'patients with metastatic RCC']","['lenvatinib-plus-everolimus', 'lenvatinib-plus-everolimus versus everolimus']","['5-factor CBS', 'progression-free survival (PFS) and overall survival (OS', 'PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF', 'PFS', 'PFS/OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0215469', 'cui_str': 'CXCL9 protein, human'}, {'cui': 'C1743775', 'cui_str': 'IL18BP protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C3849511', 'cui_str': 'ANGPT2 protein, human'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]",,0.0592448,"METHODS


Of 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively.","[{'ForeName': 'Chung-Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. leec4@mskcc.org.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Glen', 'Affiliation': 'Medical Oncology, Beatson West of Scotland Cancer Center, Glasgow, UK.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Michaelson', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Minoshima', 'Affiliation': 'Eisai Co., Ltd, Ibaraki, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Kanekiyo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ikezawa', 'Affiliation': 'Eisai, Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Sachdev', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Funahashi', 'Affiliation': 'Eisai Co., Ltd, Ibaraki, Japan.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-020-01092-0']
2729,33024299,Effects of transcranial direct current stimulation followed by exercise on neuropathic pain in chronic spinal cord injury: a double-blinded randomized controlled pilot trial.,"STUDY DESIGN


Double-blinded randomized controlled pilot trial.
OBJECTIVES


The present study aimed to investigate the effects of multiple sessions of tDCS followed by exercise on neuropathic pain and brain activity in individuals with chronic SCI.
SETTING


Rehabilitation center in Taipei, Taiwan.
METHODS


Twelve individuals with neuropathic pain after SCI were randomized into the experimental (real) or control (sham) tDCS group. All participants received 12 sessions of real or sham tDCS, and moderate upper body exercises over 4-6 weeks. Pain intensity, characters of pain, self-rating change of pain, brain activity, and quality of life were assessed at pre, posttest, and 4-week follow-up.
RESULTS


The between-group differences (95% CI) of pain intensity at posttest and at 4-week follow-up were -2.2/10 points (-3.0 to 1.0, p = 0.060) and -2.0/10 points (-5.0 to -0.4, p = 0.035), respectively. The between-group differences of paresthesia/dysesthesia pain character were -2.0/10 points (-3.2 to 1.0, p = 0.053) at posttest and -2.3/10 points (-5.0 to 2.5, p = 0.054) at follow-up. No significant changes in brain activity and quality of life were noted at post-intervention and follow-up in both groups.
CONCLUSIONS


The multiple sessions of anodal tDCS combined with moderate upper body exercise were feasible for individuals with neuropathic pain after spinal cord injury. However, the analgesic effect was not superior to exercise alone after 12 sessions of intervention, and the beneficial effect was observed at 4-week follow-up.",2020,"No significant changes in brain activity and quality of life were noted at post-intervention and follow-up in both groups.
","['chronic spinal cord injury', 'individuals with neuropathic pain after spinal cord injury', 'Twelve individuals with neuropathic pain after SCI', 'individuals with chronic SCI', 'Rehabilitation center in Taipei, Taiwan']","['anodal tDCS combined with moderate upper body exercise', 'control (sham) tDCS', 'transcranial direct current stimulation followed by exercise', '12 sessions of real or sham tDCS, and moderate upper body exercises', 'tDCS followed by exercise']","['analgesic effect', 'pain intensity', 'neuropathic pain', 'neuropathic pain and brain activity', 'brain activity and quality of life', 'beneficial effect', 'Pain intensity, characters of pain, self-rating change of pain, brain activity, and quality of life', 'paresthesia/dysesthesia pain character']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0423608', 'cui_str': 'Pain character'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0241057', 'cui_str': 'Burning sensation of skin'}]",12.0,0.170423,"No significant changes in brain activity and quality of life were noted at post-intervention and follow-up in both groups.
","[{'ForeName': 'Nai-Chen', 'Initials': 'NC', 'LastName': 'Yeh', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yea-Ru', 'Initials': 'YR', 'LastName': 'Yang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Fong', 'Initials': 'SF', 'LastName': 'Huang', 'Affiliation': 'Center for Neural Regeneration, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pei-Hsin', 'Initials': 'PH', 'LastName': 'Ku', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ray-Yau', 'Initials': 'RY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, Taiwan. rywang@ym.edu.tw.'}]",Spinal cord,['10.1038/s41393-020-00560-x']
2730,33024323,Mucous membrane grafting (fibrin glue vs. suture) for lid margin pathologies in Stevens-Johnson syndrome: randomized comparative study.,"OBJECTIVE


To compare fibrin glue (with three cardinal sutures) (FG) and polygalactin suture (PS) for mucous membrane grafting (MMG) in terms of graft apposition and recurrence of lid margin keratinization (LMK) and metaplastic lashes (ML) in patients with Stevens-Johnson syndrome (SJS).
DESIGN


Prospective randomized comparative interventional study.
METHODS


Twenty patients diagnosed with SJS and lid margin abnormalities including LMK with or without ML were randomized to undergo either fibrin glue (FG)-assisted MMG (n = 10) or continuous 8-0 polygalactin suture (PS)-assisted MMG (n = 10). They were evaluated preoperatively and during follow-up at 1 week and 1, 2, 3, and 6 months. The parameters assessed were best-corrected visual acuity (BCVA), tear break-up time (TBUT), Schirmer-1 test, corneal and conjunctival complications, graft apposition and width (GW), LMK, ML, impression cytology, and operative time. The primary outcome measures are incidence of graft displacement and recurrence of LMK and ML.
RESULTS


None of the eyelids in FG group (0/40) and 1 eyelid in PS group (1/40) had graft displacement. Recurrence of LMK occurred in 7.5% of eyelids (3/40) in both the study groups. Recurrence of ML occurred in 2.5% (1/40) in FG group and 5% (2/40) in PS group. The mean operative time for MMG in FG group was 39.5 ± 2.40 min and in PS group was 56 ± 1.63 min (p = 0.001).
CONCLUSIONS


As graft apposition with suture involves significantly longer intraoperative time, if cost is not a limiting factor then fibrin glue is a viable option for the MMG for lid margin pathologies.",2020,Recurrence of LMK occurred in 7.5% of eyelids (3/40) in both the study groups.,"['patients with Stevens-Johnson syndrome (SJS', 'Stevens-Johnson syndrome', 'Twenty patients diagnosed with SJS and lid margin abnormalities including LMK with or without ML']","['fibrin glue (with three cardinal sutures) (FG) and polygalactin suture (PS) for mucous membrane grafting (MMG', 'fibrin glue (FG)-assisted MMG (n\u2009=\u200910) or continuous 8-0 polygalactin suture (PS)-assisted MMG', 'Mucous membrane grafting (fibrin glue vs. suture']","['graft displacement', 'corrected visual acuity (BCVA), tear break-up time (TBUT), Schirmer-1 test, corneal and conjunctival complications, graft apposition and width (GW), LMK, ML, impression cytology, and operative time', 'Recurrence of LMK', 'incidence of graft displacement and recurrence of LMK and ML', 'Recurrence of ML', 'mean operative time for MMG', 'graft apposition and recurrence of lid margin keratinization (LMK) and metaplastic lashes (ML']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038325', 'cui_str': 'Stevens-Johnson syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022566', 'cui_str': 'Keratinization'}]","[{'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0022566', 'cui_str': 'Keratinization'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]",20.0,0.0762508,Recurrence of LMK occurred in 7.5% of eyelids (3/40) in both the study groups.,"[{'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Pushker', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India. pushkern@hotmail.com.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Gorimanipalli', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Kashyap', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Bajaj', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India.'}]","Eye (London, England)",['10.1038/s41433-020-01203-4']
2731,33024339,The impact of selected educational and information interventions on the coverage rate and attitudes to influenza vaccination in nursing staff.,"BACKGROUND


Influenza vaccinations are recommended for medical staff as an effective and safe form of preventing influenza and its complications. The aim of the study was to assess the impact of selected educational and information interventions on the influenza vaccination coverage (IVC) in nursing personnel and their attitude towards this procedure.
MATERIAL AND METHODS


The study participants (N = 320) were randomly divided into 4 groups. Group 1 participated in stationary training, whereas group 2 participated in distance learning. Additionally, 2 subgroups were established in each of the groups above: 1 subgroup received a reminder about the vaccination in the form of a short text message, and the other group did not receive any such reminder. The IVC rate in each group was determined; the attitude towards influenza vaccination was measured using the health belief model.
RESULTS


The highest IVC was obtained after stationary training followed by a reminder in the form of a short test message (36%). The reminder significantly affected IVC in the group attending stationary training (p < 0.05, OR = 2.5, 95% CI: 1.16-5.58); however, it had no impact on the IVC in the group participating in distance learning (p > 0.05, OR = 1.2, 95% CI: 0.51-2.83). Both stationary training and distance learning positively influenced the attitude towards influenza vaccinations. A major change in attitudes towards influenza vaccinations was observed only in the case of stationary training followed by a reminder in the form of a short text message (positive changes in perceived susceptibility and severity took place, perceived vaccination benefits increased, and perceived barriers were reduced).
CONCLUSIONS


Stationary training followed by a reminder in the form of a short text message is more effective in increasing the IVC rate compared to distance learning. It also promotes positive changes in attitudes to this prophylactic procedure, which is why it should be recommended for wider implementation. Med Pr. 2020;71(6).",2020,"The reminder significantly affected IVC in the group attending stationary training (p < 0.05, OR = 2.5, 95% CI: 1.16-5.58); however, it had no impact on the IVC in the group participating in distance learning (p > 0.05, OR = 1.2, 95% CI: 0.51-2.83).","['nursing staff', 'study participants (N = 320']","['reminder about the vaccination in the form of a short text message, and the other group did not receive any such reminder', 'stationary training, whereas group 2 participated in distance learning', 'selected educational and information interventions']","['influenza vaccination coverage (IVC', 'highest IVC', 'IVC rate', 'attitudes towards influenza vaccinations', 'attitude towards influenza vaccination', 'IVC']","[{'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0600563', 'cui_str': 'Distance Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",320.0,0.0184377,"The reminder significantly affected IVC in the group attending stationary training (p < 0.05, OR = 2.5, 95% CI: 1.16-5.58); however, it had no impact on the IVC in the group participating in distance learning (p > 0.05, OR = 1.2, 95% CI: 0.51-2.83).","[{'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Gołębiak', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland (Department of Social Medicine and Public Health).'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Okręglicka', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland (Department of Social Medicine and Public Health).'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kanecki', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland (Department of Social Medicine and Public Health).'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Nitsch-Osuch', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland (Department of Social Medicine and Public Health).'}]",Medycyna pracy,['10.13075/mp.5893.00980']
2732,33020846,A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis.,"OBJECTIVES


In RA, telemedicine may allow tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician's interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA.
METHODS


A six-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new DMARD therapy. Two groups were established: 'connected monitoring' and 'conventional monitoring'. The primary outcome was the number of physical visits between baseline and six months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12).
RESULTS


Of the 94 randomized patients, 89 completed study: 44 in the 'conventional monitoring' arm and 45 in the 'connected monitoring' arm. The total number of physical visits between required baseline and six-month visits was significantly lower in the 'connected monitoring' group [0.42 (0.58) vs 1.93 (0.55); P <0.05]. No differences between groups were observed in the clinical and functional scores. A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the 'connected monitoring' group.
CONCLUSION


Our results suggest that connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov, NCT03005925.",2020,"A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the 'connected monitoring' group.
","[""94 randomized patients, 89 completed study: 44 in the 'conventional monitoring' arm and 45 in the 'connected monitoring' arm"", 'RA patients with high to moderate disease activity starting a new DMARD therapy', 'patients with rheumatoid arthritis', 'patients with RA']",['connected monitoring interface versus physical routine monitoring'],"['quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional', 'adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12', 'total number of physical visits', 'number of physical visits', 'quality of life', 'clinical and functional scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",94.0,0.109957,"A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the 'connected monitoring' group.
","[{'ForeName': 'Yves-Marie', 'Initials': 'YM', 'LastName': 'Pers', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Verushka', 'Initials': 'V', 'LastName': 'Valsecchi', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Mura', 'Affiliation': 'Clinical Research and Epidemiology Unit (URCE).'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Aouinti', 'Affiliation': 'Clinical Research and Epidemiology Unit (URCE).'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Filippi', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marouen', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Hind', 'Initials': 'H', 'LastName': 'Letaief', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Le Blay', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Autuori', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fournet', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Mercier', 'Affiliation': 'Economic Evaluation Unit (URME), CHU Montpellier, Univ Montpellier, Montpellier, France.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Ferreira', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jorgensen', 'Affiliation': 'IRMB, University of Montpellier, INSERM U1183, CHU Montpellier.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa462']
2733,33020898,Transdermal Testosterone Attenuates Drug-Induced Lengthening of Both Early and Late Ventricular Repolarization in Older Men.,"We have previously reported that transdermal testosterone attenuates drug-induced QT interval lengthening in older men. However, it is unknown whether this is due to modulation of early ventricular repolarization, late repolarization, or both. In a secondary analysis of a prospective, randomized, double-blind, placebo-controlled three-way crossover study, we determined if transdermal testosterone and oral progesterone attenuate drug-induced lengthening of early and late ventricular repolarization, represented by the electrocardiographic measurements J-T peak  c and T peak  -T end  , respectively, as well as T peak  -T end  /QT, a measure of transmural dispersion of repolarization. Male volunteers ≥ 65 years of age (n=14) were randomized to receive transdermal testosterone 100 mg, oral progesterone 400 mg, or matching transdermal/oral placebo daily for 7 days. On the morning following the 7 th  day, subjects received intravenous ibutilide 0.003 mg/kg, after which ECGs were performed serially. One subject was excluded due to difficulty in T-wave interpretation. Pre-ibutilide J-T peak  c was lower during the testosterone phase than during progesterone and placebo (216±23 vs 227±28 vs 227±21 ms, p=0.002). Maximum post-ibutilide J-T peak  c was also lower during the testosterone phase (233±22 vs 246±29 vs 248±23 ms, p<0.0001). Pre-ibutilide T peak  -T end  was not significantly different during the three phases, but maximum post-ibutilide T peak  -T end  was lower during the testosterone phase (80±12 vs 89±18 vs 86±15 ms, p=0.002). Maximum T peak  -T end  /QT was also lower during the testosterone phase (0.199±0.023 vs 0.216±0.035 vs 0.209±0.031, p=0.005). Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT. Transdermal testosterone attenuates drug-induced lengthening of both early and late ventricular repolarization in older men.",2020,"Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT.","['Male volunteers ≥ 65 years of age (n=14', 'Older Men', 'older men']","['progesterone and placebo', 'transdermal testosterone 100 mg, oral progesterone 400 mg, or matching transdermal/oral placebo', 'T end', 'QT', 'transdermal testosterone and oral progesterone', 'Progesterone', 'placebo', 'Pre-ibutilide J-T peak', 'intravenous ibutilide', 'Transdermal testosterone', 'Transdermal Testosterone', 'Maximum post-ibutilide J-T peak', 'transdermal testosterone']","['lengthening of early and late ventricular repolarization', 'electrocardiographic measurements J-T peak  c and T peak  -T end  , respectively, as well as T peak  -T end', 'lengthening of both early and late ventricular repolarization', 'QT', 'Pre-ibutilide T peak  -T end', 'transmural dispersion of repolarization', 'Maximum T peak']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C1125815', 'cui_str': 'Testosterone 100 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0082966', 'cui_str': 'ibutilide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0082966', 'cui_str': 'ibutilide'}, {'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.263145,"Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT.","[{'ForeName': 'Elena Tomaselli', 'Initials': 'ET', 'LastName': 'Muensterman', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jaynes', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Sowinski', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Overholser', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology, School of Medicine, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tisdale', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2072']
2734,33020951,"Comparison of commercially available 0.2% chlorhexidine mouthwash with and without Anti-Discoloration System. A blinded, cross-over clinical trial.","AIM


To evaluate clinical performance and side-effects of two commercially available 0.2% chlorhexidine mouthwashes after periodontal surgery, one with (test) and one without (control) an anti-discoloration system.
MATERIAL AND METHODS


This single-centre, cross-over clinical trial included 38 patients undergoing two sessions of periodontal flap surgery. The participants used two different 0.2% chlorhexidine products, one with and one without an anti-discolouration system, in the 14-day post-operative periods. Plaque, gingival inflammation, tooth staining, side-effects and patient preference were evaluated.
RESULTS


The control mouthwash (without an anti-discolouring system) produced significantly lower plaque - (p=0.02) and gingival index (p=0.01) compared to the test mouthwash. The test mouthwash produced significantly less staining in the gingival (p=0.002) and approximal areas (p=0.0004), but no difference was detected in the buccal area of the teeth. The patients did not show preference for any of the mouthwashes.
CONCLUSION


Chlorhexidine mouthwash without an anti-discoloration system resulted in significantly lowered plaque- and gingival index compared to chlorhexidine mouthwash with an anti-discoloration following periodontal surgery. No difference in patient preference was found despite less side effects produced by the chlorhexidine mouthwash with the anti-discolouration system.",2020,"The test mouthwash produced significantly less staining in the gingival (p=0.002) and approximal areas (p=0.0004), but no difference was detected in the buccal area of the teeth.",['38 patients undergoing two sessions of periodontal flap surgery'],"['chlorhexidine mouthwashes', 'chlorhexidine', 'chlorhexidine mouthwash with and without Anti-Discoloration System', 'Chlorhexidine']","['plaque - (p=0.02) and gingival index', 'Plaque, gingival inflammation, tooth staining, side-effects and patient preference', 'plaque- and gingival index', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",38.0,0.0699635,"The test mouthwash produced significantly less staining in the gingival (p=0.002) and approximal areas (p=0.0004), but no difference was detected in the buccal area of the teeth.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Klepsland Mauland', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Norway.'}, {'ForeName': 'Hans R', 'Initials': 'HR', 'LastName': 'Preus', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Norway.'}, {'ForeName': 'Anne Merete', 'Initials': 'AM', 'LastName': 'Aass', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Norway.'}]",Journal of clinical periodontology,['10.1111/jcpe.13382']
2735,33020985,Telehealth-delivered CBT-I programme enhanced by acceptance and commitment therapy for insomnia and hypnotic dependence: A pilot randomized controlled trial.,"Cognitive behavioural therapy for insomnia is the recommended treatment for chronic insomnia. However, up to a quarter of patients dropout from cognitive behavioural therapy for insomnia programmes. Acceptance, mindfulness and values-based actions may constitute complementary therapeutic tools to cognitive behavioural therapy for insomnia. The current study sought to evaluate the efficacy of a remotely delivered programme combining the main components of cognitive behavioural therapy for insomnia (sleep restriction and stimulus control) with the third-wave cognitive behavioural therapy acceptance and commitment therapy in adults with chronic insomnia and hypnotic dependence on insomnia symptoms and quality of life. Thirty-two participants were enrolled in a pilot randomized controlled trial: half of them were assigned to a 3-month waiting list before receiving the four ""acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia"" treatment sessions using videoconference. The primary outcome was sleep quality as measured by the Insomnia Severity Index and the Pittsburgh Sleep Quality Index. All participants also filled out questionnaires about quality of life, use of hypnotics, depression and anxiety, acceptance, mindfulness, thought suppression, as well as a sleep diary at baseline, post-treatment and 6-month follow-up. A large effect size was found for Insomnia Severity Index and Pittsburgh Sleep Quality Index, but also daytime improvements, with increased quality of life and acceptance at post-treatment endpoint in acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia participants. Improvement in Insomnia Severity Index and Pittsburgh Sleep Quality Index was maintained at the 6-month follow-up. Wait-list participants increased their use of hypnotics, whereas acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia participants evidenced reduced use of them. This pilot study suggests that web-based cognitive behavioural therapy for insomnia incorporating acceptance and commitment therapy processes may be an efficient option to treat chronic insomnia and hypnotic dependence.",2020,"Wait-list participants increased their use of hypnotics, whereas acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia participants evidenced reduced use of them.","['adults with chronic insomnia and hypnotic dependence on insomnia symptoms and quality of life', 'insomnia and hypnotic dependence', 'Thirty-two participants']","['Cognitive behavioural therapy', 'waiting list before receiving the four ""acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia"" treatment sessions using videoconference', 'web-based cognitive behavioural therapy', 'remotely delivered programme combining the main components of cognitive behavioural therapy for insomnia (sleep restriction and stimulus control) with the third-wave cognitive behavioural therapy acceptance and commitment therapy']","['quality of life, use of hypnotics, depression and anxiety, acceptance, mindfulness, thought suppression, as well as a sleep diary', 'quality of life and acceptance', 'sleep quality as measured by the Insomnia Severity Index and the Pittsburgh Sleep Quality Index', 'Insomnia Severity Index and Pittsburgh Sleep Quality Index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C1386573', 'cui_str': 'Hypnotic dependence'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",32.0,0.0560703,"Wait-list participants increased their use of hypnotics, whereas acceptance and commitment therapy-enhanced cognitive behavioural therapy for insomnia participants evidenced reduced use of them.","[{'ForeName': 'Mélinée', 'Initials': 'M', 'LastName': 'Chapoutot', 'Affiliation': 'Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, Bron, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Peter-Derex', 'Affiliation': 'Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, Bron, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schoendorff', 'Affiliation': 'Institut de Psychologie Contextuelle, Montreal, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Faivre', 'Affiliation': 'Clinique Lyon-Lumière 33B, Meyzieu, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bastuji', 'Affiliation': 'Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, Bron, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Putois', 'Affiliation': 'Lyon Neuroscience Research Centre, CNRS UMR 5292 - INSERM U1028 - Lyon 1 University, Bron, France.'}]",Journal of sleep research,['10.1111/jsr.13199']
2736,33021044,Effect of Food Intake on the Pharmacokinetics of the Selective Progesterone Receptor Modulator Vilaprisan: A Randomized Clinical Study in Healthy Postmenopausal Women.,"This exploratory, open-label, randomized, 3-period crossover study in 12 healthy postmenopausal women investigated the effects of food intake on the pharmacokinetics of vilaprisan. Single doses of vilaprisan (2 mg) were administered under fasting conditions, after intake of a high-fat, high-calorie meal, and after intake of a moderate-fat, moderate-calorie meal. The intake of food had only a marginal impact on the oral bioavailability of vilaprisan. The mean exposure of vilaprisan (area under the plasma concentration-time curve [AUC]) was increased by approximately 20% when the drug was taken after a meal and not on an empty stomach (point estimate for AUC ratios [%] and 90% confidence interval: high-fat and -calorie meal/fasting 121 [114-128]; moderate-fat and -calorie meal/fasting 118 [111-125]). The rate of absorption was slightly decreased when the drug was taken after a meal as indicated by approximately 10% lower mean maximum concentrations (C max  ) of vilaprisan in plasma (C max  ratios: high-fat and -calorie meal/fasting 87.9 [75.6-102]; moderate-fat and -calorie meal/fasting 89.4 [76.9-104]) and a prolonged time to C max  (fasting: 1.5 hours; fed conditions; ∼4 hours). Overall, the results of this study indicate that vilaprisan can be administered equally well with or without food.",2020,The mean exposure of vilaprisan (area under the plasma concentration-time curve [AUC]) was increased by approximately 20% when the drug was taken after a meal and not on an empty stomach (point estimate for AUC ratios [%] and 90% confidence interval: high-fat and -calorie meal/fasting 121 [114-128]; moderate-fat and -calorie meal/fasting 118 [111-125]).,"['Healthy Postmenopausal Women', '12 healthy postmenopausal women']","['Food Intake', 'Progesterone Receptor Modulator Vilaprisan', 'vilaprisan']","['prolonged time to C max', 'mean exposure of vilaprisan (area under the plasma concentration-time curve [AUC', 'rate of absorption', 'oral bioavailability of vilaprisan']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",12.0,0.0212986,The mean exposure of vilaprisan (area under the plasma concentration-time curve [AUC]) was increased by approximately 20% when the drug was taken after a meal and not on an empty stomach (point estimate for AUC ratios [%] and 90% confidence interval: high-fat and -calorie meal/fasting 121 [114-128]; moderate-fat and -calorie meal/fasting 118 [111-125]).,"[{'ForeName': 'Marcus-Hillert', 'Initials': 'MH', 'LastName': 'Schultze-Mosgau', 'Affiliation': 'Bayer AG, Clinical Pharmacology, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaiser', 'Affiliation': 'Bayer AG, Statistics & Data Insights, Berlin, Germany.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Zollmann', 'Affiliation': 'Pharma Consult, Berlin, Germany.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.876']
2737,33021047,"Academic performance of dental students: A randomized trial comparing live, audio recorded, and video recorded lectures.","OBJECTIVES


To compare the academic performance of 4th-year dental students randomly divided into three learning groups; live lecture, video recorded lecture, and audio recorded lecture. To assess students' attitudes towards the three learning methods.
MATERIALS AND METHODS


4 th  year undergraduate students, enrolled in the Orthodontics Theory - 1 course, were randomized into three groups receiving different teaching methods; video recorded lecture, audio recorded lecture, and live-lecture. Subjects were asked to answer two open ended questions. The first was a simple basic knowledge question in which the answer involved transcribing information from the question, while the second required analytical thinking. Students were also asked to complete a questionnaire assessing their attitudes towards the three learning methods.
RESULTS


94 students participated in the study and were randomly allocated to each learning method. There were no significant differences in scores between the 3 study groups when answering the basic knowledge question (P>0.05). The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05). The majority of students agreed that lectures were an essential part of their learning experience and that lectures allowed interaction between students and lecturer. Two-thirds of students reported that watching a video recorded lecture provided a similar learning experience to attending a live lecture.
CONCLUSION


Video recorded, audio recorded and live lectures were found to be equally effective for providing basic knowledge. Video recorded and live lectures were more effective than audio recorded lecture at assessing higher levels of analytical thinking. Students attending video recorded lecture performed as well as those attending the live lecture.",2020,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"['4 th  year undergraduate students, enrolled in the Orthodontics Theory - 1 course', 'dental students', '94 students participated in the study']","['learning groups; live lecture, video recorded lecture, and audio recorded lecture', 'teaching methods; video recorded lecture, audio recorded lecture, and live-lecture']","['mean score for the analytic question', 'academic performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",94.0,0.0222829,The mean score for the analytic question was significantly higher for the live lecture and video recorded lecture groups compared to the audio recorded lecture group (P<0.05).,"[{'ForeName': 'Abedalrahman J', 'Initials': 'AJ', 'LastName': 'Shqaidef', 'Affiliation': 'Department of Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Abu-Baker', 'Affiliation': 'University of Jordan, Amman, Jordan.'}, {'ForeName': 'Zaid Bakri', 'Initials': 'ZB', 'LastName': 'Al-Bitar', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Badran', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Hamdan', 'Affiliation': 'Department Pediatric Dentistry and Orthodontics, University of Jordan, Amman, Jordan.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12614']
2738,33021081,"Pharmacokinetics of Ginsenoside Rh2, the Major Anticancer Ingredient of Ginsenoside H Dripping Pills, in Healthy Subjects.","Ginsenoside H dripping pill (GH) is a novel clinical-stage adjuvant for the treatment of non-small cell lung cancer. In this study, the pharmacokinetics of ginsenoside Rh2, the major anticancer ingredient of GH, was investigated in healthy volunteers. Enrolled volunteers were assigned to 3 cohorts-7.8, 15.6, and 31.2 mg-and received single and/or multiple GH orally. Blood samples were assayed by a validated bioanalytical method, and drug concentrations were analyzed using a noncompartmental methodology. The results showed that ginsenoside Rh2 was absorbed with medium speed and reached C max  a median of 3 hours after administration. The exposure of ginsenoside Rh2 was approximately dose-dependent in terms of AUC and C max  . The plasma concentration of ginsenoside Rh2 reached steady state after oral administration of GH twice daily for 5 days. There was no obvious accumulation in exposure parameters in the multiple-dose study.",2020,The exposure of ginsenoside Rh2 was approximately dose-dependent in terms of AUC and C max  .,"['healthy volunteers', 'Healthy Subjects']","['Ginsenoside H dripping pill (GH', 'single and/or multiple GH orally']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0061278', 'cui_str': 'Panaxosides'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],,0.0260999,The exposure of ginsenoside Rh2 was approximately dose-dependent in terms of AUC and C max  .,"[{'ForeName': 'Zhenlei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Tasly Academy, Tasly Holding Group Co. Ltd., Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huanhuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Phase I Unit, Clinical Pharmacology Research Center, Peking Union Medical College Hospital & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Tasly Academy, Tasly Holding Group Co. Ltd., Tianjin, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'GCP Center/Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.877']
2739,33021115,The effect of Capacitive and Resistive electric transfer on non-specific chronic low back pain.,"The objective of this study was to evaluate the effect of Capacitive and Resistive electric transfer (CRet)-combined exercise therapy for participants with non-specific chronic low back pain (NSCLBP). Twenty-six received only the exercise program (E group, n = 15), or received both CRet and the same exercise program (E+CRet group, n = 11). Pain intensity, functional disability and trunk function were measured pre-, and post-intervention and there was also a 1-month follow-up period. Data analysis was performed for each index using the Mann-Whitney U test for comparisons between two groups at each time point, and the Wilcoxon signed-rank test for comparison between each time point within the group. The results of this study indicate that pain intensity was improved in both groups at post-intervention, also, the effect continued during follow-up period. In addition, functional disability was significantly improved in the E+CRet group at the post-intervention and during the follow-up period. The intervention effect on NSCLBP was higher in the E+CRet group than the E group. CRet, which is a form of deep thermotherapy, combined with exercise have a possibility of more effectiveness than exercise alone.",2020,"Pain intensity, functional disability and trunk function were measured pre-, and post-intervention","['non-specific chronic low back pain', 'participants with non-specific chronic low back pain (NSCLBP']","['Capacitive and Resistive electric transfer (CRet)-combined exercise therapy', 'E+CRet', 'Capacitive and Resistive electric transfer', 'exercise program (E group, n =\xa015), or received both CRet and the same exercise program (E+CRet']","['Pain intensity, functional disability and trunk function', 'functional disability', 'NSCLBP', 'pain intensity']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]",,0.0279466,"Pain intensity, functional disability and trunk function were measured pre-, and post-intervention","[{'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Tashiro', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Nakayama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Sonoda', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Mirei', 'Initials': 'M', 'LastName': 'Kawagoe', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Tsuboyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine , Kyoto, Japan.'}]",Electromagnetic biology and medicine,['10.1080/15368378.2020.1830795']
2740,33017212,"Randomized, Controlled Trial Comparing Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The CAMRA CardioLink-2 Study.","BACKGROUND


Equipoise exists between the use of leaflet resection and preservation for surgical repair of mitral regurgitation caused by prolapse. We therefore performed a randomized, controlled trial comparing these 2 techniques, particularly in regard to functional mitral stenosis.
METHODS


One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers. Exclusion criteria included anterior leaflet or commissural prolapse, as well as a mixed cause for mitral valve disease. Using previous data, we determined that a sample size of 88 subjects would provide 90% power to detect a 5-mm Hg difference in mean mitral valve gradient at peak exercise, assuming an SD of 6.7 mm with a 2-sided test with α=5% and 10% patient attrition. The primary end point was the mean mitral gradient at peak exercise 12 months after repair.
RESULTS


Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50). There were no perioperative deaths or conversions to replacement. At 12 months, moderate mitral regurgitation was observed in 3 subjects in the leaflet resection group and 2 in the leaflet preservation group. The mean transmitral gradient at 12 months during peak exercise was 9.1±5.2 mm Hg after leaflet resection and 8.3±3.3 mm Hg after leaflet preservation ( P =0.43). The participants had similar resting peak (8.3±4.4 mm Hg versus 8.4±2.6 mm Hg;  P =0.96) and mean resting (3.2±1.9 mm Hg versus 3.1±1.1 mm Hg;  P =0.67) mitral gradients after leaflet resection and leaflet preservation, respectively. The 6-minute walking distance was 451±147 m for those in the leaflet resection versus 481±95 m for the leaflet preservation group ( P =0.27).
CONCLUSIONS


In this adequately powered randomized trial, repair of mitral prolapse with either leaflet resection or leaflet preservation was associated with similar transmitral gradients at peak exercise at 12 months postoperatively. These data do not support the hypothesis that a strategy of leaflet resection (versus preservation) is associated with a risk of functional mitral stenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT02552771.",2020,There were no perioperative deaths or conversions to replacement.,"['One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers', 'Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50', 'Functional Mitral Stenosis']","['Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation', 'leaflet resection or leaflet preservation']","['moderate mitral regurgitation', 'perioperative deaths', 'mean transmitral gradient', '6-minute walking distance', 'mean mitral gradient at peak exercise 12 months after repair', 'mean mitral valve gradient at peak exercise']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}]","[{'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C1301895', 'cui_str': 'Perioperative death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}]",104.0,0.158607,There were no perioperative deaths or conversions to replacement.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, ON, Canada (V.C., M.R., T.M.).'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia (C.D.M.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Faeez Mohamad', 'Initials': 'FM', 'LastName': 'Ali', 'Affiliation': ""Division of Cardiology (F.M.A., W.T., H.L.-P.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quan', 'Affiliation': ""Division of Cardiac Surgery (A.Q., A.D., D.A.L., H.T., S.V.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, ON, Canada (V.C., M.R., T.M.).'}, {'ForeName': 'Benoit E', 'Initials': 'BE', 'LastName': 'de Varennes', 'Affiliation': 'Division of Cardiac Surgery, Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada (B.E.d.V.).'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Cumming School of Medicine, University of Calgary, AB, Canada (A.J.G.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Bouchard', 'Affiliation': 'Department of Cardiac Surgery, Montreal Heart Institute and Université de Montréal, QC, Canada (D.B.).'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Whitlock', 'Affiliation': 'Division of Cardiac Surgery (R.P.W.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michael W A', 'Initials': 'MWA', 'LastName': 'Chu', 'Affiliation': 'Division of Cardiac Surgery, London Health Sciences Center, University of Western Ontario, Canada (M.W.A.C.).'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Dokollari', 'Affiliation': ""Division of Cardiac Surgery (A.Q., A.D., D.A.L., H.T., S.V.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Mesana', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, ON, Canada (V.C., M.R., T.M.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Latter', 'Affiliation': ""Division of Cardiac Surgery (A.Q., A.D., D.A.L., H.T., S.V.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Tsang', 'Affiliation': ""Division of Cardiology (F.M.A., W.T., H.L.-P.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Hwee', 'Initials': 'H', 'LastName': 'Teoh', 'Affiliation': ""Division of Cardiac Surgery (A.Q., A.D., D.A.L., H.T., S.V.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Leong-Poi', 'Affiliation': ""Division of Cardiology (F.M.A., W.T., H.L.-P.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery (A.Q., A.D., D.A.L., H.T., S.V.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.""}]",Circulation,['10.1161/CIRCULATIONAHA.120.046853']
2741,33017328,Impact of Training Based on Orem's Theory on Self-Care Agency and Quality of Life in Patients With Coronary Artery Disease.,"BACKGROUND


Coronary artery disease (CAD) is a primary cause of death worldwide. CAD negatively affects individuals because it reduces their functional skills and self-care abilities and disrupts quality of life.
PURPOSE


This study was designed to assess the impact of a training program based on Orem's self-care deficit nursing theory (SCDNT) on self-care abilities and quality of life in patients with CAD.
METHODS


This study was conducted using a randomized, controlled, pretest/posttest experimental design. One hundred two patients with CAD were divided evenly into either the intervention or control group, with sample randomization based on gender, age, low-density lipoprotein cholesterol level, and Self-Care Agency Scale scores. For both groups, interviews were conducted in two sessions held, respectively, at the hospital and at home. Study data were collected using the patient information form, Self-Care Agency Scale, MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew), Quality of Life Questionnaire (15D), and training booklet.
RESULTS


A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
CONCLUSIONS


The training program developed in this study based on Orem's SCDNT improved self-care agency as well as disease-specific and overall quality of life in patients with CAD. Nurses should pay attention to the CAD-related educational level of patients when teaching them how to live with their disease. Moreover, nurses should use Orem's SCDNT to strengthen the self-care agency of these patients to increase quality of life and the effectiveness of related education efforts. Finally, medical institutions and governments should develop appropriate education policies for patients at risk of CAD and for those with CAD.",2020,"A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
","['Patients With Coronary Artery Disease', 'One hundred two patients with CAD', 'patients with CAD', 'patients at risk of CAD and for those with CAD']","[""training program based on Orem's self-care deficit nursing theory (SCDNT""]","['density lipoprotein cholesterol level, and Self-Care Agency Scale scores', 'functional skills and self-care abilities and disrupts quality of life', 'Self-Care Agency Scale, MacNew, and 15D', 'Self-Care Agency Scale, MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew), Quality of Life Questionnaire (15D), and training booklet', 'Self-Care Agency and Quality of Life', 'self-care abilities and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231369', 'cui_str': 'Total self-care deficit'}, {'cui': 'C0028700', 'cui_str': 'Theory, Nursing'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]",102.0,0.0233579,"A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Tok Yildiz', 'Affiliation': ''}, {'ForeName': 'Mağfiret', 'Initials': 'M', 'LastName': 'KaŞikÇi', 'Affiliation': 'PhD, RN, Professor, Faculty of Nursing, Atatürk University, Erzurum, Turkey.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000406']
2742,33017341,The Effect of Integrating Primary Care and Mental Health Services on Diabetes and Depression: A Multi-site Impact Evaluation on the US-Mexico Border.,"BACKGROUND


Health care delivery systems are increasingly integrating physical and mental health services to address patients' complex needs, contain costs, and improve satisfaction. Therefore, it is critical to understand whether adoption of integrated care models is effective in diverse settings.
OBJECTIVE


This study examined the effect of integrated care on physical and mental health outcomes among low-income Latino participants on the US-Mexico border.
RESEARCH DESIGN


In this quasi-experimental multisite study, individual-level data were pooled from 8 studies of locally adapted integrated care models.
SUBJECTS


Participants were 18 years or older and had 1 or more chronic conditions: diabetes, depression, hypertension, or obesity. The study enrolled 4226 participants with 2254 participants in the intervention group and 1972 in the comparison group.
MEASURES


Primary outcomes were depressive symptoms as measured by the Patient Health Questionnaire-9 score and blood glucose measured by hemoglobin A1c (HbA1c). Blood pressure, body mass index, and quality of life were secondary outcomes.
RESULTS


Multivariable linear regression analyses indicated intervention participants had significantly lower Patient Health Questionnaire-9 scores (β=-0.39, P=0.03) and HbA1c (β=-0.14, P=0.02) at 12 months compared with comparison group participants. Stratified analyses showed improvements in HbA1c were even greater among intervention participants who had diabetes, depression, severe and persistent mental illness, were older or female compared with their counterparts in the comparison group.
CONCLUSIONS


Health care is constantly transforming, making it critical to study these changes across populations and settings. Findings from this study indicate that integrated care can significantly improve mental and physical health in an underserved Latino population.",2020,"Stratified analyses showed improvements in HbA1c were even greater among intervention participants who had diabetes, depression, severe and persistent mental illness, were older or female compared with their counterparts in the comparison group.
","['underserved Latino population', 'Participants were 18 years or older and had 1 or more chronic conditions: diabetes, depression, hypertension, or obesity', 'Diabetes and Depression', '4226 participants with 2254 participants in the intervention group and 1972 in the comparison group', 'low-income Latino participants on the US-Mexico border']","['Integrating Primary Care and Mental Health Services', 'integrated care']","['Blood pressure, body mass index, and quality of life', 'diabetes, depression, severe and persistent mental illness', 'physical and mental health outcomes', 'Patient Health Questionnaire-9 scores', 'depressive symptoms as measured by the Patient Health Questionnaire-9 score and blood glucose measured by hemoglobin A1c (HbA1c', 'mental and physical health']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",4226.0,0.0296329,"Stratified analyses showed improvements in HbA1c were even greater among intervention participants who had diabetes, depression, severe and persistent mental illness, were older or female compared with their counterparts in the comparison group.
","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Wolff', 'Affiliation': 'Health Resources in Action Inc.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Health Resources in Action Inc.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University School of Public Health.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Errichetti', 'Affiliation': 'Tufts University School of Medicine, Boston, MA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tapia Walker', 'Affiliation': 'Steuck & Associates Inc.'}, {'ForeName': 'Michelle K', 'Initials': 'MK', 'LastName': 'Brodesky', 'Affiliation': 'Methodist Healthcare Ministries, San Antonio, TX.'}]",Medical care,['10.1097/MLR.0000000000001429']
2743,33017362,"The 11th Trial of a Cardiovascular Clinical Trialist-Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
2744,33017385,[Bacterial colonization after applying an educational program: A quasi-experimental study].,"Introduction


Educational interventions can raise awareness and understanding in population groups and may help to achieve changes in behavior.
Objective


To determine if the educational handwashing program applied to high-school students reduces the colonization of infectious bacteria on the hands.
Methods


A non-randomized quasi-experimental study was carried out using consecutive sampling of the students of the last year of high-school who were divided into an intervention group and a control group. Data were obtained before and after the implementation of the educational program. Samples were taken from the dominant hand for bacterial culture, and a questionnaire was applied that assessed knowledge of hand hygiene before and after the program. The program was aimed at improving the level of understanding and attitudes of students regarding hand hygiene.
Results


Of 208 samples obtained, the most frequent agents before and after the educational program were Staphylococcus epidermidis (39% versus 23%) and Staphylococcus aureus (21% versus 15%). The average number of colonies was 236 and 183 respectively (p = 0.35).
Conclusion


The educational program managed to improve the level of understanding about hand hygiene; however, it was not enough to reduce bacterial colonization, so other behaviors such as direct supervision should be considered.",2020,"The educational program managed to improve the level of understanding about hand hygiene; however, it was not enough to reduce bacterial colonization, so other behaviors such as direct supervision should be considered.",['consecutive sampling of the students of the last year of high-school who were divided into an intervention group and a control group'],[],"['Staphylococcus aureus', 'average number of colonies', 'Staphylococcus epidermidis']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}]",,0.0117877,"The educational program managed to improve the level of understanding about hand hygiene; however, it was not enough to reduce bacterial colonization, so other behaviors such as direct supervision should be considered.","[{'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Montalvo', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. Adress: Avenida Mariscal Castilla 3909, El Tambo, Huancayo, Perú. Email: otivo3@hotmail.com. ORCID: 0000-0003-0227-8850.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Ochoa', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0001-5668-2926.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Baltazar', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0001-8060-061X.'}, {'ForeName': 'Armida', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0002-1819-1664.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Acuña', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0003-3493-0866.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Custodio', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0003-1994-010X.'}, {'ForeName': 'Dayana', 'Initials': 'D', 'LastName': 'Barreto', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0003-4091-0458.'}, {'ForeName': 'Hylen', 'Initials': 'H', 'LastName': 'Canto', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0002-5988-7713.'}, {'ForeName': 'Nilda', 'Initials': 'N', 'LastName': 'Cárdenas', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0001-9870-4791.'}, {'ForeName': 'Néstor', 'Initials': 'N', 'LastName': 'Flores', 'Affiliation': 'Facultad de Medicina Humana, Universidad Nacional del Centro del Perú, Huancayo, Perú. ORCID: 0000-0001-8711-4112.'}]",Medwave,['10.5867/medwave.2020.08.8029']
2745,33017523,Influence of different post-endodontic restorations on the fatigue survival and biomechanical behavior of central incisors.,"PURPOSE


To evaluate the influence of different post-endodontic techniques on the fatigue survival and biomechanical behavior of crowned restored central incisors.
METHODS


The crowns of 69 bovine incisors were cut, and the roots were treated endodontically and assigned randomly into three groups (n=23): resin composite buildup (BUP), glass fiber post-retained resin composite buildup (GFP), and cast post-and-core (CPC). They received full crown preparation with 2 mm ferrule, and a leucite-reinforced ceramic crown was cemented adhesively. Three specimens from each group were tested monotonically. The remaining specimens were subjected to the stepwise stress fatigue test until fracture or suspension after 1.5 x 10⁶ cycles in a chewing simulator. The load and step at which each specimen failed were analyzed by Kaplan-Meier and Mantel-Cox (log-rank test) statistics, followed by multiple pairwise comparisons, at 5% significance level. The three groups tested (BUP, GFP, and CPC) were 3D modeled (Rhinoceros 4.0) and the maximum principal stress (MPa) criteria were used to calculate the results using FEA.
RESULTS


There was no statistical difference between the treatments regarding the load or the number of cycles (Mantel-Cox log-rank test for trend, X²= 0.015, df=1, P= 0.901, X²=3.171, df=1, P= 0.995). Crown cracks were the predominant failure mode, and oblique root fractures were only observed in groups GFP and CPC. In endodontically treated incisors with a 2-mm ferrule, the post-endodontic treatment had no significant effect on fatigue survival. Non-restorable fractures only occurred in teeth restored with posts.
CLINICAL SIGNIFICANCE


Although the clinical significance of laboratory studies has some limitations, this study suggests that composite buildups without posts may be an option for restoring endodontically treated incisors with 2 mm ferrule height.",2020,"There was no statistical difference between the treatments regarding the load or the number of cycles (Mantel-Cox log-rank test for trend,","['The crowns of 69 bovine incisors were cut, and the roots were treated endodontically and assigned randomly into three groups (n=23']","['resin composite buildup (BUP), glass fiber post-retained resin composite buildup (GFP), and cast post-and-core (CPC']","['fatigue survival and biomechanical behavior', 'fatigue survival. Non-restorable fractures', 'fatigue survival and biomechanical behavior of central incisors']","[{'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]",69.0,0.0292848,"There was no statistical difference between the treatments regarding the load or the number of cycles (Mantel-Cox log-rank test for trend,","[{'ForeName': 'Guilherme S', 'Initials': 'GS', 'LastName': 'De Andrade', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil.'}, {'ForeName': 'João Paulo M', 'Initials': 'JPM', 'LastName': 'Tribst', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil, joao.tribst@gmail.com.'}, {'ForeName': 'Esteban If', 'Initials': 'EI', 'LastName': 'Orozco', 'Affiliation': 'Department of Restorative Dentistry, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil.'}, {'ForeName': 'Marina G', 'Initials': 'MG', 'LastName': 'Augusto', 'Affiliation': 'Department of Dentistry, São Francisco University, Braganç, SP, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Bottino', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil.'}, {'ForeName': 'Alexandre Ls', 'Initials': 'AL', 'LastName': 'Borges', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil.'}, {'ForeName': 'Lilian C', 'Initials': 'LC', 'LastName': 'Anami', 'Affiliation': 'Department of Dentistry, Santo Amaro University, São Paulo, SP, Brazil.'}, {'ForeName': 'Guilherme deSFA', 'Initials': 'GD', 'LastName': 'Saavedra', 'Affiliation': 'Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), Institute of Science and Technology, São José dos Campos, SP, Brazil.'}]",American journal of dentistry,[]
2746,33017529,Enhanced plaque removal to improve gingival health: 3-month randomized clinical study of the effects of baking soda toothpaste on plaque and gingivitis.,"PURPOSE


To compare the effectiveness in reducing plaque and gingivitis of a fluoride toothpaste with 20% baking soda and a fluoride toothpaste control.
METHODS


159 subjects, who met the entry criteria, participated in this single-center, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed after 4, 8, and 12 weeks use of the assigned test or control toothpaste. After 12 weeks, participants resumed 4 weeks of their customary oral hygiene after which they were re-evaluated using the same measures.
RESULTS


Both toothpastes statistically significantly reduced MGI, GBI, and PI versus baseline at all-time points. Brushing with the 20% baking soda toothpaste statistically significantly reduced MGI, PI, and GBI compared to the control toothpaste at all time points. After 12 weeks, the reductions in MGI, PI, and GBI were 12.6%, 9.6%, and 44.2%, respectively. After the 4-week customary oral hygiene period, the benefits of the study period had begun to diminish, but statistically significant reductions in MGI and GBI for the test versus control were still evident. This 3-month clinical study shows that brushing with fluoride toothpaste containing 20% baking soda reduces dental plaque and concurrently reduces gingival inflammation and bleeding compared to toothpaste with fluoride alone.
CLINICAL SIGNIFICANCE


Fluoride toothpaste with 20% baking soda has the potential to offer multiple oral health benefits when used as an adjunct to regular tooth brushing and, therefore, may be confidently recommended to patients.",2020,"Brushing with the 20% baking soda toothpaste statistically significantly reduced MGI, PI, and GBI compared to the control toothpaste at all time points.","['159 subjects, who met the entry criteria, participated in this single-center']","['control toothpaste', 'fluoride toothpaste with 20% baking soda and a fluoride toothpaste control', 'Fluoride toothpaste', 'baking soda toothpaste', 'fluoride toothpaste']","['MGI and GBI', 'plaque and gingivitis', 'reductions in MGI, PI, and GBI', 'gingival inflammation and bleeding', 'reduced MGI, PI, and GBI', 'MGI, GBI, and PI', 'Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",159.0,0.0479274,"Brushing with the 20% baking soda toothpaste statistically significantly reduced MGI, PI, and GBI compared to the control toothpaste at all time points.","[{'ForeName': 'Naresh C', 'Initials': 'NC', 'LastName': 'Sharma', 'Affiliation': 'BioSci Research Canada Ltd., Mississauga, Canada.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Goyal', 'Affiliation': 'BioSci Research Canada Ltd., Mississauga, Canada.'}, {'ForeName': 'Jimmy G', 'Initials': 'JG', 'LastName': 'Qaqish', 'Affiliation': 'BioSci Research Canada Ltd., Mississauga, Canada.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Vorwerk', 'Affiliation': 'Sr. Clinical Research Scientist, Church and Dwight Co., Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hooper', 'Affiliation': 'Program Scientist, Church and Dwight Co., Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Annahita', 'Initials': 'A', 'LastName': 'Ghassemi', 'Affiliation': 'Global Product Safety & Clinical Affairs, Church and Dwight Co., Inc., Princeton, New Jersey, USA, annahita.ghassemi@churchdwight.com.'}]",American journal of dentistry,[]
2747,33017530,The effects of two baking-soda toothpastes in enhancing mechanical plaque removal and improving gingival health: A 6-month randomized clinical study.,"PURPOSE


To compare the effectiveness in reducing plaque and gingivitis of two fluoride toothpastes containing baking soda (35% and 20%) with a fluoride toothpaste control.
METHODS


319 subjects, who met entry criteria, participated in this single-center, three-cell, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed at baseline, and after 6 weeks, 3 and 6 months.
RESULTS


All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points. After 6 months use, the 35% and 20% baking soda toothpastes had reduced MGI, GBI and PI by 15.0%, 46.9%, and 18.3%, and 9.4%, 25.9%, and 12.4%, respectively, compared to the control. In addition, the 35% baking soda toothpaste had reduced (P≤ 0.0005) MGI, GBI, and PI by 6.2%, 28.4%, and 6.8%, respectively, compared to the 20% baking soda toothpaste. This clinical study showed that brushing with fluoride toothpastes containing baking soda at 35% and 20% reduces plaque, gingival inflammation and bleeding more effectively than regular fluoride toothpaste. Further, it showed that 35% baking soda toothpaste was more effective in reducing these parameters than 20% baking soda toothpaste.
CLINICAL SIGNIFICANCE


Fluoride toothpastes containing 20% or more baking soda can provide significant and meaningful gingival health benefits when used regularly as an adjunct to tooth brushing.",2020,"All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points.","['319 subjects, who met entry criteria, participated in this single-center, three-cell']","['regular fluoride toothpaste', 'fluoride toothpastes', 'two baking-soda toothpastes', 'fluoride toothpaste control', 'Fluoride toothpastes']","['mechanical plaque removal and improving gingival health', 'reduced MGI, GBI and PI', 'MGI, GBI, and PI', 'meaningful gingival health benefits', 'Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI', 'plaque, gingival inflammation and bleeding']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}]",319.0,0.0457272,"All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points.","[{'ForeName': 'Annahita', 'Initials': 'A', 'LastName': 'Ghassemi', 'Affiliation': 'Global Product Safety & Clinical Affairs, Church and Dwight Co., Inc., Princeton, New Jersey, USA, annahita.ghassemi@churchdwight.com.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hooper', 'Affiliation': 'Program Scientist, Church and Dwight Co., Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Vorwerk', 'Affiliation': 'Sr. Clinical Research Scientist, Church and Dwight Co., Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Petrovicova', 'Affiliation': 'Personal Care R&D, Church and Dwight Co. Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Goyal', 'Affiliation': 'Independent Clinical Investigator, All Sum Research Center Ltd., Mississauga, Canada.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Qaqish', 'Affiliation': 'Independent Clinical Investigator, All Sum Research Center Ltd., Mississauga, Canada.'}, {'ForeName': 'Jimmy G', 'Initials': 'JG', 'LastName': 'Qaqish', 'Affiliation': 'Independent Clinical Investigator, All Sum Research Center Ltd., Mississauga, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Santos', 'Affiliation': 'Consultant, SLS Clinical Reearch Consulting, LLC, Pine Brook, NJ, USA.'}]",American journal of dentistry,[]
2748,33017565,Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial.,"BACKGROUND


Few studies have examined primary care management for acute sciatica, including referral to physical therapy.
OBJECTIVE


To evaluate whether early referral to physical therapy reduced disability more than usual care (UC) alone for patients with acute sciatica.
DESIGN


Randomized controlled clinical trial. (ClinicalTrials.gov: NCT02391350).
SETTING


2 health care systems in Salt Lake City, Utah.
PATIENTS


220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation.
INTERVENTION


All participants received imaging and medication at the discretion of the primary care provider before enrollment. A total of 110 participants randomly assigned to UC were provided 1 session of education, and 110 participants randomly assigned to early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy.
MEASUREMENTS


The primary outcome was the Oswestry Disability Index (OSW) score after 6 months. Secondary outcomes were pain intensity, patient-reported treatment success, health care use, and missed workdays.
RESULTS


Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points];  P  = 0.009). The OSW and several secondary outcomes favored EPT after 4 weeks. After 1 year, between-group differences favored EPT for the OSW (relative difference, -4.8 points [CI, -8.9 to -0.7 points]) and back pain intensity (relative difference, -1.0 points [CI, -1.6 to -0.4 points]). The EPT group was more likely to self-report treatment success after 1 year (45.2%) than the UC group (27.6%) (relative risk, 1.6 [CI, 1.1 to 2.4]). There were no significant differences in health care use or missed workdays.
LIMITATION


The patients and providers were unblinded, and specific physical therapy interventions responsible for effects could not be determined.
CONCLUSION


Referral from primary care to physical therapy for recent-onset sciatica improved disability and other outcomes compared with UC.
PRIMARY FUNDING SOURCE


Agency for Healthcare Research and Quality.",2020,"Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points];  P  = 0.009).","['110 participants randomly assigned to', ""220 adults aged 18 to 60 years with sciatica of less than 90 days' duration who were making an initial primary care consultation"", '2 health care systems in Salt Lake City, Utah', 'patients with acute sciatica', 'Physical Therapy Referral From Primary Care for Acute']","['usual care (UC) alone', 'early physical therapy (EPT) were provided 1 education session and then referred for 4 weeks of physical therapy, including exercise and manual therapy', 'UC', 'EPT']","['OSW', 'Oswestry Disability Index (OSW) score', 'pain intensity, patient-reported treatment success, health care use, and missed workdays', 'self-report treatment success', 'health care use or missed workdays', 'Back Pain', 'back pain intensity']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",110.0,0.118286,"Participants in the EPT group had greater improvement from baseline to 6 months for the primary outcome (relative difference, -5.4 points [95% CI, -9.4 to -1.3 points];  P  = 0.009).","[{'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'College of Health, University of Utah, Salt Lake City, Utah (J.M.F.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lane', 'Affiliation': 'University of Utah, Salt Lake City, Utah (E.L., J.S.M., A.T.).'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'McFadden', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, Utah (M.M., T.G.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Brennan', 'Affiliation': 'Rehabilitation Services, Intermountain Healthcare, Salt Lake City, Utah (G.B.).'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Magel', 'Affiliation': 'University of Utah, Salt Lake City, Utah (E.L., J.S.M., A.T.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thackeray', 'Affiliation': 'University of Utah, Salt Lake City, Utah (E.L., J.S.M., A.T.).'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Minick', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, Utah (K.M.).'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'University of Utah Health, Salt Lake City, Utah (W.M.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, Utah (M.M., T.G.).'}]",Annals of internal medicine,['10.7326/M20-4187']
2749,33024480,Evaluation of oral immunotherapy efficacy and safety by maintenance dose dependency: A multicenter randomized study.,"Background


Generally, oral immunotherapy (OIT) aims for daily administration. Recently, the efficacy of treatment with OIT at a low dose has been reported. However, the optimal dose and the evaluation of dose-dependent OIT outcome have not been described.
Methods


A multicenter, parallel, open-labeled, prospective, non-placebo controlled, randomized study enrolled 101 Japanese patients for treatment with OIT. We hypothesized that target dose OIT would induce short-term unresponsiveness (StU) earlier than reduced dose OIT. StU was defined as no response to 6200 mg whole egg, 3400 mg milk, and 2600 mg wheat protein, as evaluated by oral food challenge after 2-week ingestion cessation. To compare the two doses of OIT efficacy, the maximum ingestion doses during the maintenance phase of OIT were divided into 100%-dose or 25%-dose groups against their target StU dose, respectively. A total of 51 patients were assigned to the 100%-dose group [hen's egg (HE) = 26, cow's milk (CM) = 13, wheat = 12] and 50 to the 25%-dose group (HE = 25, CM = 13, wheat = 12). Primary outcome was established by comparing StU at 1 year. Secondary outcome was StU at 2 years and established by comparing allergic symptoms and immunological changes.
Results


The year 1 StU rates (%) for the 100%- and 25%-dose groups were 26.9 vs. 20.0 (HE), 7.7 vs. 15.4 (CM), and 50.0 vs. 16.7 (wheat), respectively. The year 2 StU rates were 30.8 vs. 36.0 (HE), 7.7 vs. 23.1 (CM), and 58.3 vs. 58.3 (wheat), respectively. There were no statistically significant differences in StU between years 1 and 2. The total allergic symptom rate in the 25%-dose group was lower than that in the 100%-dose group for egg, milk, and wheat. Antigen-specific IgE levels for egg-white, milk, and wheat decreased at 12 months.
Conclusions


Reduced maintenance dose of egg OIT showed similar therapeutic efficacy to the target dose. However, we were not able to clearly demonstrate the efficacy, particularly for milk and wheat. Reducing the maintenance dose for eggs, milk, and wheat may effectively lower the symptoms associated with their consumption compared to the target OIT dose. Furthermore, aggressive reduction of the maintenance dose might be important for milk and wheat, compared to the 25%-dose OIT.
Trial registration


UMIN000009373, Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat-Allergic Children at Outpatient Clinic.",2020,"The total allergic symptom rate in the 25%-dose group was lower than that in the 100%-dose group for egg, milk, and wheat.","['101 Japanese patients for treatment with OIT', ""Hen's Egg, Cow's Milk, and Wheat-Allergic Children at Outpatient Clinic"", ""51 patients were assigned to the 100%-dose group [hen's egg (HE)\xa0=\xa026, cow's milk (CM)\xa0=\xa013, wheat\xa0=\xa012] and 50 to the 25%-dose group (HE\xa0""]","['placebo', 'oral immunotherapy (OIT']","['total allergic symptom rate', 'StU at 2 years and established by comparing allergic symptoms and immunological changes', 'year 2 StU rates', 'therapeutic efficacy']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",101.0,0.0896403,"The total allergic symptom rate in the 25%-dose group was lower than that in the 100%-dose group for egg, milk, and wheat.","[{'ForeName': 'Kiyotake', 'Initials': 'K', 'LastName': 'Ogura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Yanagida', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Course of Allergy and Clinical Immunology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Kando', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Fukuyama Medical Center, Hiroshima, Japan.'}, {'ForeName': 'Rumiko', 'Initials': 'R', 'LastName': 'Shibata', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Fukuoka National Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Fukuoka National Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Institute for Clinical Research, National Hospital Organization, Mie National Hospital, Mie, Japan.'}, {'ForeName': 'Mizuho', 'Initials': 'M', 'LastName': 'Nagao', 'Affiliation': 'Institute for Clinical Research, National Hospital Organization, Mie National Hospital, Mie, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Kawamoto', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Urisu', 'Affiliation': 'Department of Pediatrics, Fujita Health University, The Second Teaching Hospital, Aichi, Japan.'}, {'ForeName': 'Ikuya', 'Initials': 'I', 'LastName': 'Tsuge', 'Affiliation': 'Department of Pediatrics, Fujita Health University, The Second Teaching Hospital, Aichi, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Pediatrics, Fujita Health University, The Second Teaching Hospital, Aichi, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sugai', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Yokohama Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Uchida', 'Affiliation': 'Department of Pediatrics, National Hospital Organization, Yokohama Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'Course of Allergy and Clinical Immunology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Course of Allergy and Clinical Immunology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",The World Allergy Organization journal,['10.1016/j.waojou.2020.100463']
2750,33024488,Anatomy Versus Physiology-Guided Ablation for Persistent Atrial Fibrillation.,"Background


Pulmonary vein isolation remains the cornerstone of atrial fibrillation (AF) ablation. However, due to high recurrence rates, especially in patients with persistent AF, PV antral isolation, complemented by linear ablation, autonomic modulation, and ablation of complex fractionated electrograms, have been attempted to increase the odds of success. However, the optimum approach for a complementary strategy in addition to PVI for persistent AF is unknown.
Methods


We performed a prospective randomized trial by assigning 92 patients with persistent AF in 1:1 ratio to pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity (45 patients), or pulmonary-vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus (47 patients). The duration of follow-up was five years. The primary endpoint was freedom from any documented recurrence of atrial fibrillation after a single ablation procedure.
Results


At a 12-month follow-up, 9 (23%) patients had AF recurrence in the linear ablation and 8 (21%) patients in the CFAE groups. At a mean follow-up duration of 59±36 months, 48.3% of patients in the linear ablation group and 44.6% of patients in the CFAE group were free from AF (p=0.403). There were no significant differences between the two groups for independent predictors of freedom from AF. The overall procedure time and radiation exposure were higher in the PVI+linear ablation group. There were five adverse events noted, two in the linear group (pericardial effusion not requiring drain) and 3 in the CFAE group (1 pseudoaneurysm, one effusion requiring pericardiocentesis and one effusion nor requiring drain).
Conclusions


Among patients with persistent atrial fibrillation, we found no difference in maintenance of sinus rhythm in either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary vein isolation in short- and long-term follow-up.",2020,", we found no difference in maintenance of sinus rhythm in either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary vein isolation in short- and long-term follow-up.","['92 patients with persistent AF in 1:1 ratio to pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity (45 patients), or', 'patients with persistent atrial fibrillation', 'across the left atrial roof and mitral valve isthmus (47 patients']","['pulmonary-vein isolation plus additional linear ablation', 'CFAE', 'Anatomy Versus Physiology-Guided Ablation']","['effusion requiring pericardiocentesis and one effusion nor requiring drain', 'AF recurrence', 'overall procedure time and radiation exposure', 'freedom from any documented recurrence of atrial fibrillation', 'maintenance of sinus rhythm']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0191234', 'cui_str': 'Pericardiocentesis'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]",92.0,0.0218536,", we found no difference in maintenance of sinus rhythm in either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary vein isolation in short- and long-term follow-up.","[{'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Slusser', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Xiao', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hodge', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mélèze', 'Initials': 'M', 'LastName': 'Hocini', 'Affiliation': 'Bordeaux University Hospital, LIRYC institute, Pessac, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McLeod', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bradley', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Munger', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Packer', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yong-Mei', 'Initials': 'YM', 'LastName': 'Cha', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}]",Journal of atrial fibrillation,['10.4022/jafib.2280']
2751,33024493,Meditation for Improved Clinical Outcomes in Patients with Implantable Defibrillators for Heart Failure- Pilot Study.,"Background


Sympathetic activation is associated with congestive heart failure (CHF) and leads to adverse clinical events.We hypothesized that meditation by reducing emotional reactivity would have beneficial effect in reducing arrhythmias compared to control patients.
Methods


Patients known to have CHF and implantable cardioverter defibrillators (ICD) were randomized to Vipassana meditation or usual care control group. Meditation group underwent meditation classes three times during the first week, thereafter every once two weeks. They were encouraged to practice meditation at least once everyday. The ICD was followed by clinic/ remote visits. Atrial (AA) and ventricular arrhythmias (VA) as well cardiac events were assessed in follow up. Chi square test was used to compare nominal variables and t test for continuous variables.
Results


Patients (n=25, 65% male, mean LVEF 25%, HTN 38%, Diabetes 12%, coronary artery disease 38%, NYHA class 2.2) were followed for 79 + 36 months. Comparing meditation vs control, survival was higher (88%vs 67%); there was less cumulative sustained AF episodes (mean 0.9, IQR 0-1 vs 2.5, IQR 2-4, p=0.045), sustained VT occurred (25% vs 55%, amiodarone use (none vs 44%), and VT ablation in 6.6% vs 33% in the meditation group.
Conclusions


In this first pilot study of meditation in CHF patients with ICD, during long term follow up, there is a trend for improved survival and reduced arrhythmias in patients randomized to meditation.",2020,"Comparing meditation vs control, survival was higher (88%vs 67%); there was less cumulative sustained AF episodes (mean 0.9, IQR 0-1 vs 2.5, IQR 2-4, p=0.045), sustained VT occurred (25% vs 55%, amiodarone use (none vs 44%), and VT ablation in 6.6% vs 33% in the meditation group.
","['Patients with Implantable Defibrillators for Heart Failure- Pilot Study', 'CHF patients with ICD', 'Methods\n\n\nPatients known to have CHF and implantable cardioverter defibrillators (ICD']","['amiodarone', 'Vipassana meditation or usual care control group', 'Meditation']","['emotional reactivity', 'survival and reduced arrhythmias', 'Atrial (AA) and ventricular arrhythmias (VA', 'sustained VT', 'survival', 'cumulative sustained AF episodes', 'VT ablation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0750197', 'cui_str': 'Sustained ventricular tachycardia'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",,0.0425176,"Comparing meditation vs control, survival was higher (88%vs 67%); there was less cumulative sustained AF episodes (mean 0.9, IQR 0-1 vs 2.5, IQR 2-4, p=0.045), sustained VT occurred (25% vs 55%, amiodarone use (none vs 44%), and VT ablation in 6.6% vs 33% in the meditation group.
","[{'ForeName': 'Dash', 'Initials': 'D', 'LastName': 'Aditee', 'Affiliation': 'Division of Cardiovascular Medicine.'}, {'ForeName': 'Malhotra', 'Initials': 'M', 'LastName': 'Pankaj', 'Affiliation': 'Division of Cardiovascular Medicine.'}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Neil', 'Affiliation': 'Division of Cardiovascular Medicine.'}, {'ForeName': 'Pezeshkian', 'Initials': 'P', 'LastName': 'Nayereh', 'Affiliation': 'Division of Cardiovascular Medicine.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Dali', 'Affiliation': 'Division of Cardiovascular Medicine.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'N Srivatsa', 'Affiliation': 'Division of Cardiovascular Medicine.'}]",Journal of atrial fibrillation,['10.4022/jafib.2314']
2752,33024523,Evaluation of Reversed Administration Order of Busulfan (BU) and Cyclophosphamide (CY) as Conditioning on Liver Toxicity in Allogenic Hematopoietic Stem Cell Transplantation (ALL-HSCT).,"Background:  Busulfan (BU) in combination with cyclophosphamide (CY) is used as an effective conditioning regimen in hematopoietic SCT. Busulfan, depletes glutathione level in liver and causes elevated levels of CY metabolites. Cyclophosphamide metabolites are highly toxic for sinusoidal endothelial cells and cause VOD/ SOS with high mortality rate.  Materials and Methods:  Between September 2013 and September 2015, all adult patients with acute leukemia who were candidates for myeloablative allogenic SCT and were admitted to Stem Cell Transplantation center were enrolled in this prospective randomized clinical trial. We tested the hypothesis that reverse administration from BU-CY (n=28) to CY-BU group (n=27) would reduce liver toxicity.  Results:  Liver function tests were significantly higher in the BU-CY group between day -1 and +4 (p<0.05), but VOD/SOS was not diagnosed in both groups. The incidence and severity of acute GVHD was higher in the BU-CY group, but not statistically significant. Engraftment and mortality rate were not different.  Conclusion:  These data support the concept that CY-BU is associated with less liver toxicity, suggesting CY-BU is superior to BU-CY as conditioning.",2020,"were significantly higher in the BU-CY group between day -1 and +4 (p<0.05), but VOD/SOS was not diagnosed in both groups.","['September 2013 and September 2015', 'adult patients with acute leukemia who were candidates for myeloablative allogenic SCT and were admitted to Stem Cell Transplantation center', 'Allogenic Hematopoietic Stem Cell Transplantation (ALL-HSCT']","['Busulfan (BU) and Cyclophosphamide (CY', 'BU-CY', 'Busulfan (BU', 'Busulfan', 'Cyclophosphamide metabolites', 'cyclophosphamide (CY']","['incidence and severity of acute GVHD', 'Liver function tests', 'liver toxicity', 'VOD/SOS', 'Engraftment and mortality rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0261491,"were significantly higher in the BU-CY group between day -1 and +4 (p<0.05), but VOD/SOS was not diagnosed in both groups.","[{'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Ramzi', 'Affiliation': 'Hematology and Bone Marrow Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Namdari', 'Affiliation': 'Department of Hematology and Medical Oncology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Department of Hematology, Hematology Research Center, Medical Oncology and Stem Cell Transplantation, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hourvash', 'Initials': 'H', 'LastName': 'Haghighinejad', 'Affiliation': 'Department of Family Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International journal of hematology-oncology and stem cell research,['10.18502/ijhoscr.v14i3.3725']
2753,33024925,Impact of rs174537 on Critically Ill Patients with Acute Lung Injury: A Secondary Analysis of the OMEGA Randomized Clinical Trial.,"Background


Nutrition in the intensive care unit is vital for patient care; however, immunomodulatory diets rich in PUFAs like γ-linolenic acid (GLA), EPA, and DHA remain controversial for patients with acute respiratory distress syndrome. We postulate that genetic variants impacting PUFA metabolism contribute to mixed responses to PUFA-rich diets.
Objectives


In this study, we aimed to test the effects of single nucleotide polymorphism (SNP) rs174537 on differential responses to PUFA-rich diets.
Methods


We performed a secondary analysis of the OMEGA trial (NCT00609180) where 129 subjects received placebo control diets and 143 received omega-oil. DNA was extracted from buffy coats and used to genotype rs174537; plasma was used to quantitate PUFAs. We tested for SNP-diet interactions on PUFA concentrations, inflammatory biomarkers, and patient outcomes.
Results


We observed that all individuals receiving omega-oil displayed significantly higher concentrations of GLA, EPA, and DHA (all  P  < 0.0001), but they did not vary by genotype at rs174537. Statistically significant SNP-diet interactions were observed on circulating DHA concentrations in African Americans. Specifically, African American T-allele carriers on placebo illustrated elevated DHA concentrations. Additionally, all individuals receiving omega-oil had higher concentrations of EPA-derived urinary F3-isoprostane (Caucasians:  P  = 0.0011; African Americans:  P  = 0.0002). Despite these findings, we did not detect any significant SNP-diet interactions on pulmonary functional metrics, clinical outcomes, and mortality.
Conclusions


This study highlights the importance of genetic and racial contributions to PUFA metabolism and inflammation. In particular, rs174537 had a significant impact on circulating DHA and urinary isoprostane concentrations. Given our relatively small sample size, further investigations in larger multiethnic cohorts are needed to evaluate the impact of rs174537 on fatty acid metabolism and downstream inflammation.",2020,"We observed that all individuals receiving omega-oil displayed significantly higher concentrations of GLA, EPA, and DHA (all  P  ","['Critically Ill Patients with Acute Lung Injury', '129 subjects received', 'patients with acute respiratory distress syndrome', 'African Americans']","['rs174537', 'placebo control diets and 143 received omega-oil', 'single nucleotide polymorphism (SNP) rs174537']","['concentrations of EPA-derived urinary F3-isoprostane', 'circulating DHA concentrations', 'circulating DHA and urinary isoprostane concentrations', 'pulmonary functional metrics, clinical outcomes, and mortality', 'concentrations of GLA, EPA, and DHA (all  P']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0949860', 'cui_str': 'Isoprostane'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}]",,0.253743,"We observed that all individuals receiving omega-oil displayed significantly higher concentrations of GLA, EPA, and DHA (all  P  ","[{'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Dosso', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Charlotte Mae K', 'Initials': 'CMK', 'LastName': 'Waits', 'Affiliation': 'Department of Biomedical Engineering, Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'Kelli N', 'Initials': 'KN', 'LastName': 'Simms', 'Affiliation': 'Department of Biomedical Engineering, Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sergeant', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Department of Internal Medicine, Sections in Pulmonary and Critical Care Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Howard', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Langefeld', 'Affiliation': 'Center for Precision Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Floyd H', 'Initials': 'FH', 'LastName': 'Chilton', 'Affiliation': 'Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Rahbar', 'Affiliation': 'Department of Biomedical Engineering, Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences, Winston-Salem, NC, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa147']
2754,33024938,"Long-Term, All-Day Exposure to Circadian-Effective Light Improves Sleep, Mood, and Behavior in Persons with Dementia.","Background


Persons with Alzheimer's disease and related dementias (ADRD) frequently experience sleep-wake (circadian) cycle disturbances that lead them to remain awake at night, causing stress and fatigue for families and caregivers. Light therapy shows promise as a nonpharmacological treatment for regulating sleep in this population.
Objective


We investigated the long-term impact of a circadian-effective lighting intervention on sleep, mood, and behavior problems in persons with ADRD.
Methods


This 25-week clinical trial administered an all-day lighting intervention to 47 patients with ADRD in 9 senior-care facilities, employing wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior.
Results


The intervention significantly improved Pittsburgh Sleep Quality Index scores, from an estimated mean±SEM of 11.89±0.53 at baseline to 5.36±0.63 at the end of the intervention. Additional improvements were noted for sleep efficiency data from actigraph measurements. The intervention significantly reduced Cornell Scale for Depression in Dementia scores (mean±SEM of 11.36±0.74 at baseline and 4.18±0.88 at the end of the intervention) and Cohen-Mansfield Agitation Inventory scores (mean±SEM of 47.10±1.98 at baseline and 35.33±2.23 at the end of the intervention).
Conclusion


A regular circadian-effective daytime lighting intervention can improve sleep at night and reduce depression and agitation in patients with dementia living in controlled environments. More importantly, the positive effects of the tailored lighting intervention on these outcomes appear to be cumulative over time.",2020,"The intervention significantly reduced Cornell Scale for Depression in Dementia scores (mean±SEM of 11.36±0.74 at baseline and 4.18±0.88 at the end of the intervention) and Cohen-Mansfield Agitation Inventory scores (mean±SEM of 47.10±1.98 at baseline and 35.33±2.23 at the end of the intervention).
","['Persons with Dementia', ""\n\n\nPersons with Alzheimer's disease and related dementias (ADRD"", 'patients with dementia living in controlled environments', '47 patients with ADRD in 9 senior-care facilities', 'persons with ADRD']","['regular circadian-effective daytime lighting intervention', 'Light therapy', 'circadian-effective lighting intervention']","['Pittsburgh Sleep Quality Index scores', 'sleep quality, mood, and behavior', 'Cornell Scale for Depression in Dementia scores', 'Cohen-Mansfield Agitation Inventory scores', 'sleep, mood, and behavior problems', 'Sleep, Mood, and Behavior']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014409', 'cui_str': 'Controlled Environment'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",47.0,0.0427631,"The intervention significantly reduced Cornell Scale for Depression in Dementia scores (mean±SEM of 11.36±0.74 at baseline and 4.18±0.88 at the end of the intervention) and Cohen-Mansfield Agitation Inventory scores (mean±SEM of 47.10±1.98 at baseline and 35.33±2.23 at the end of the intervention).
","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kalsher', 'Affiliation': 'Department of Cognitive Science, School of Humanities, Arts and Social Sciences, Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Plitnick', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Rea', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, NY, USA.'}]",Journal of Alzheimer's disease reports,['10.3233/ADR-200212']
2755,33024990,Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio.,"BACKGROUND


Increasing the total protein content and reducing the casein to whey ratio in milks consumed with breakfast cereal reduce postprandial blood glucose (BG).
OBJECTIVES


We aimed to explore associations between plasma amino acids (AAs), BG, and glucoregulatory hormones.
METHODS


In this repeated-measures design, 12 healthy adults consumed cereal (58 g) and milks (250 mL) with 3.1 wt% or high 9.3 wt% protein concentrations and with casein to whey ratios of either 80:20 or 40:60. Blood was collected at 0, 30, 60, 120, 140, 170, and 200 min for measurement of the primary outcome, BG, and for the exploratory outcomes such as plasma AA, gastric emptying, insulin (INS), and glucoregulatory hormones. Measures were made prior to and after an ad libitum lunch at 120 min. Exploratory correlations were conducted to determine associations between outcomes.
RESULTS


Pre-lunch plasma AA groups [total (TAA), essential (EAA), BCAA, and nonessential (NEAA)] were higher after 9.3 wt% than 3.1 wt% milks by 12.7%, 21.4%, 20.9%, and 7.6%, respectively (P ≤ 0.05), while post-lunch AA groups were higher by 10.9%, 19.8%, 18.8%, and 6.0%, respectively (P ≤ 0.05). Except for NEAA, pre-lunch AAs were higher after 40:60 than 80:20 ratio milks by 4.5%, 8.3%, and 9.3% (P ≤ 0.05). When pooled by all treatments, pre-lunch AA groups associated negatively with BG (r/ρ ≥ -0.45, P ≤ 0.05), but post-lunch only TAA and NEAA correlated (r ≥ -0.37, P < 0.05). Pre-lunch BG was inversely associated with Leu, Ile, Lys, Met, Thr, Cys-Cys, Asn, and Gln (r/ρ ≥ -0.46, P ≤ 0.05), but post-lunch, only with Thr, Ala, and Gly (r ≥ -0.50, P ≤ 0.05). Pre-lunch associations between AA groups and INS were not found.
CONCLUSIONS


Protein concentration and the ratio of casein to whey in milks consumed at breakfast with cereal affect plasma AA concentrations and their associations with decreased BG. The decrease in BG could be explained by INS-independent mechanisms. This trial was registered at www.clinicaltrials.gov as NCT02471092.",2020,"Pre-lunch BG was inversely associated with Leu, Ile, Lys, Met, Thr, Cys-Cys, Asn, and Gln (r/ρ ≥ -0.46, P ≤ 0.05), but post-lunch, only with Thr, Ala, and Gly (r ≥","['Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio', '12 healthy adults consumed cereal (58 g) and milks (250\xa0mL) with 3.1 wt% or high 9.3 wt% protein concentrations and with casein to whey ratios of either 80:20 or 40:60']",['Amino Acids'],"['plasma amino acids (AAs), BG, and glucoregulatory hormones', 'postprandial blood glucose (BG', 'plasma AA, gastric emptying, insulin (INS), and glucoregulatory hormones', 'BG', 'Pre-lunch plasma AA groups [total (TAA), essential (EAA), BCAA, and nonessential (NEAA', 'Pre-lunch BG', 'Blood Glucose Changes', 'plasma AA concentrations']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",12.0,0.099941,"Pre-lunch BG was inversely associated with Leu, Ile, Lys, Met, Thr, Cys-Cys, Asn, and Gln (r/ρ ≥ -0.46, P ≤ 0.05), but post-lunch, only with Thr, Ala, and Gly (r ≥","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Kung', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sylvie L', 'Initials': 'SL', 'LastName': 'Turgeon', 'Affiliation': 'STELA Dairy Research Centre, Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Vien', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Kubant', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'El Khoury', 'Affiliation': 'Department of Family Relations & Applied Nutrition, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'H Douglas', 'Initials': 'HD', 'LastName': 'Goff', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'G Harvey', 'Initials': 'GH', 'LastName': 'Anderson', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa275']
2756,33025104,Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hemorrhoidal disease: a non-inferiority randomized controlled trial.,"BACKGROUND


In this study, we proposed a combined outpatient treatment modality for hemorrhoidal disease.
METHODS


This study was a prospective non-inferiority randomized controlled trial (RCT). The experimental group included the dearterialization and hemorrhoidopexy under pudendal nerve block, whereas the comparator consisted of the standard Doppler guided hemorrhoidal artery ligation and hemorrhoidopexy, under spinal anesthesia. As primary hypothesis, we considered the non-inferiority of the proposed modality in terms of the presenting symptom remission rate (non-inferiority margin: 10%). Randomization was based on a 1:1 ratio. Blinding was confined to the patient and the investigator.
RESULTS


Overall, 60 patients were enrolled. The primary hypothesis of this RCT (96.7% vs 73.3%) was validated. The experimental group was associated with a lower operation duration and an expedited onset of mobilization and feeding. Moreover, a favorable profile regarding short-term morbidity and analgesia was identified. The control group displayed a higher pile recurrence rate and a suboptimal patient satisfaction. A significant effect of the treatment modality in most of the SF-36 components was confirmed.
CONCLUSIONS


The proposed treatment modality was associated with favorable short and long-term outcomes. Due to specific limitations, further RCTs, with a larger sample size, are required. Trial Registration ClinicalTrials.gov : NCT03298997.",2020,The control group displayed a higher pile recurrence rate and a suboptimal patient satisfaction.,"['hemorrhoidal disease', '60 patients were enrolled']","['Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block', 'dearterialization and hemorrhoidopexy under pudendal nerve block, whereas the comparator consisted of the standard Doppler guided hemorrhoidal artery ligation and hemorrhoidopexy, under spinal anesthesia']","['symptom remission rate', 'lower operation duration and an expedited onset of mobilization and feeding', 'pile recurrence rate']","[{'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0189722', 'cui_str': 'Ligation of artery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.287958,The control group displayed a higher pile recurrence rate and a suboptimal patient satisfaction.,"[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Perivoliotis', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Mezourlo, 41110, Larissa, Greece. kperi19@gmail.com.'}, {'ForeName': 'Michail', 'Initials': 'M', 'LastName': 'Spyridakis', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Mezourlo, 41110, Larissa, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Zintzaras', 'Affiliation': 'Department of Biomathematics, School of Medicine, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Arnaoutoglou', 'Affiliation': 'Department of Anesthesiology, University Hospital of Larissa, Mezourlo, 41110, Larissa, Greece.'}, {'ForeName': 'Manousos-Georgios', 'Initials': 'MG', 'LastName': 'Pramateftakis', 'Affiliation': 'Fourth Surgical Department, Medical School, Aristotle University of Thessaloniki, 57010, Thessaloniki, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tepetes', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Mezourlo, 41110, Larissa, Greece.'}]",International journal of colorectal disease,['10.1007/s00384-020-03768-8']
2757,33025143,'Seven-step two-lobe' HoLEP: a modification to gain efficiency of the enucleation applying relatively low-power holmium laser devices.,"PURPOSE


In order to increase the efficiency of the low-power holmium laser enucleation of the prostate (LP-HoLEP), and introduce it as a standard surgery for BPH, we described a modified 'seven-step two-lobe' HoLEP (ST HoLEP) technique applying 60-W device in a stepwise manner.
METHODS


From July 2016 to August 2019, 120 patients who received LP-HoLEP at our hospital because of urinary tract symptoms caused by BPH were included in the study. The patients were assigned into two groups, 60 consecutive patients received modified ST HoLEP compared with another preexisting 60 consecutive patients who received the conventional three-lobe HoLEP (T HoLEP) before the technical modification. The clinical parameters, including patient characteristics, perioperative data, as well as voiding outcomes, and complications were evaluated after at least 3-month follow-up.
RESULTS


The median enucleation efficiency of the ST HoLEP was 0.72 gm/min, which was significantly higher than 0.62 gm/min of the T HoLEP. Despite the preoperative IPSS was slightly higher in T HoLEP group, the other preoperative and perioperative data showed no statistical difference between the two groups. After ST HoLEP procedure, the urinary incontinence rate was continually improved at 1-week, 1-month, and 3-month follow-up which were 13.3%, 6.7%, and 1.7%, respectively. There was no significant difference in postoperative voiding outcomes and urinary continence results in 3-month follow-up.
CONCLUSION


The ST HoLEP technique was proved to increase the efficiency which was benefit from minimizing the surgical incision, facilitating the single surgical plane identification and maintenance during the whole enucleation procedure.",2020,"The median enucleation efficiency of the ST HoLEP was 0.72 gm/min, which was significantly higher than 0.62 gm/min of the T HoLEP.","['From July 2016 to August 2019, 120 patients who received LP-HoLEP at our hospital because of urinary tract symptoms caused by BPH were included in the study', '60 consecutive patients received']","['modified ST HoLEP', 'conventional three-lobe HoLEP (T HoLEP', 'holmium laser enucleation of the prostate (LP-HoLEP']","['preoperative IPSS', 'patient characteristics, perioperative data, as well as voiding outcomes, and complications', 'median enucleation efficiency of the ST HoLEP', 'urinary incontinence rate', 'postoperative voiding outcomes and urinary continence results']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",60.0,0.0139678,"The median enucleation efficiency of the ST HoLEP was 0.72 gm/min, which was significantly higher than 0.62 gm/min of the T HoLEP.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Peking University Third Hospital, No.49, North Garden Rd. Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, Peking University Third Hospital, No.49, North Garden Rd. Haidian District, Beijing, 100191, China. xiaochunleixcl@sina.cn.'}, {'ForeName': 'Yichang', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Urology, Peking University Third Hospital, No.49, North Garden Rd. Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Lulin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, Peking University Third Hospital, No.49, North Garden Rd. Haidian District, Beijing, 100191, China.'}]",World journal of urology,['10.1007/s00345-020-03470-y']
2758,33025146,Application of a surgical guide in the extraction of impacted mesiodentes: a randomized controlled trial.,"OBJECTIVE


To explore and evaluate the application of a surgical guide in the extraction of impacted mesiodentes.
MATERIALS AND METHODS


Patients with impacted mesiodentes approachable from the labial side of the maxilla were randomly divided into three groups. The surgical guide for group I was made using cone beam computed tomography (CBCT) and dental cast, whereas the surgical guide for group II was only made using CBCT data. Group I and group II were first evaluated to determine whether guide use could accurately locate the cementoenamel junction (CEJ) of the mesiodentes, and the impacted mesiodentes were extracted with the help of the surgical guide. Group III underwent an operation without a guide. For all patients, the preoperative design time, tooth searching time, operation time, complications, and costs were measured.
RESULTS


The guides for group I and group II could locate the CEJ of the mesiodentes accurately, with good application effect during the operation. Group I and group II required additional preoperative design time compared with group III. However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III. Group I and group II showed no intraoperative complications, and two cases in group III showed imprecision during localization. The overall cost for group III was higher than that of group I or group II. But group I and group II required extra visits and costs.
CONCLUSIONS


Despite some limitations, the surgical guide assisted with mesiodentes extraction and can improve the quality of the operation quality as well as reducing its economic burden, difficulty, and duration. Through proper design, we can create a high-quality surgical guide using only CBCT data.
CLINICAL RELEVANCE


The surgical guide can be used as an important assistive tool in alveolar surgery.",2020,"However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III.","['impacted mesiodentes', 'Patients with impacted mesiodentes approachable from the labial side of the maxilla']",[],"['tooth searching time and operation time', 'preoperative design time, tooth searching time, operation time, complications, and costs', 'overall cost', 'intraoperative complications']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0266030', 'cui_str': 'Supernumerary mesiodens tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]",[],"[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}]",,0.0154595,"However, the tooth searching time and operation time in groups I and II were significantly reduced compared with those in group III.","[{'ForeName': 'Xianghuai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Shuguang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Center of Oral Implantology, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China. 654365980@qq.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03620-x']
2759,33025229,A below-knee compression garment reduces fatigue-induced strength loss but not knee joint position sense errors.,"PURPOSE


We examined the possibility that wearing a below-knee compression garment (CG) reduces fatigue-induced strength loss and joint position sense (JPS) errors in healthy adults.
METHODS


Subjects (n = 24, age = 25.5 ± 4 years) were allocated to either one of the treatment groups that performed 100 maximal isokinetic eccentric contractions at 30° -1  with the right-dominant knee extensors: (1) with (EXPCG) or (2) without CG (EXP) or to (3) a control group (CONCG: CG, no exercise). Changes in JPS errors, and maximal voluntary isometric contraction (MVIC) torque were measured immediately post-, 24 h post-, and 1 week post-intervention in each leg. All testing was done without the CG.
RESULTS


CG afforded no protection against JPS errors. Mixed analysis of variance (ANOVA) revealed that absolute JPS errors increased post-intervention in EXPCG and EXP not only in the right-exercised (52%, p = 0.013; 57%, p = 0.007, respectively) but also in the left non-exercised (55%, p = 0.001; 58%, p = 0.040, respectively) leg. Subjects tended to underestimate the target position more in the flexed vs. extended knee positions (75-61°: - 4.6 ± 3.6°, 60-50°: - 4.2 ± 4.3°, 50-25°: - 2.9 ± 4.2°), irrespective of group and time. Moreover, MVIC decreased in EXP but not in EXPCG and CONCG at immediately post-intervention (p = 0.026, d = 0.52) and 24 h post-intervention (p = 0.013, d = 0.45) compared to baseline.
CONCLUSION


Altogether, a below-knee CG reduced fatigue-induced strength loss at 80° knee joint position but not JPS errors in healthy younger adults.",2020,"Mixed analysis of variance (ANOVA) revealed that absolute JPS errors increased post-intervention in EXPCG and EXP not only in the right-exercised (52%, p = 0.013; 57%, p = 0.007, respectively) but also in the left non-exercised (55%, p = 0.001; 58%, p = 0.040, respectively) leg.","['Subjects (n\u2009', '24, age\u2009=\u200925.5\u2009±\u20094\xa0years', 'healthy adults', 'healthy younger adults']","['100 maximal isokinetic eccentric contractions at 30° -1  with the right-dominant knee extensors: (1) with (EXPCG) or (2) without CG (EXP) or to (3) a control group (CONCG: CG, no exercise', 'wearing a below-knee compression garment (CG']","['fatigue-induced strength loss', 'JPS errors, and maximal voluntary isometric contraction (MVIC) torque', 'fatigue-induced strength loss and joint position sense (JPS) errors', 'MVIC decreased in EXP', 'absolute JPS errors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.0187321,"Mixed analysis of variance (ANOVA) revealed that absolute JPS errors increased post-intervention in EXPCG and EXP not only in the right-exercised (52%, p = 0.013; 57%, p = 0.007, respectively) but also in the left non-exercised (55%, p = 0.001; 58%, p = 0.040, respectively) leg.","[{'ForeName': 'János', 'Initials': 'J', 'LastName': 'Négyesi', 'Affiliation': 'Division of Biomedical Engineering for Health and Welfare, Tohoku University Graduate School of Biomedical Engineering, Sendai, Japan. negyesi@tohoku.ac.jp.'}, {'ForeName': 'Li Yin', 'Initials': 'LY', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine and Science in Sports and Exercise, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Rui Nian', 'Initials': 'RN', 'LastName': 'Jin', 'Affiliation': 'Department of Medicine and Science in Sports and Exercise, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Nagatomi', 'Affiliation': 'Division of Biomedical Engineering for Health and Welfare, Tohoku University Graduate School of Biomedical Engineering, Sendai, Japan.'}]",European journal of applied physiology,['10.1007/s00421-020-04507-1']
2760,33025241,Biomechanical comparison of vertical suture techniques for repairing radial meniscus tear.,"PURPOSE


The aim of this study was to (1) develop suture techniques in repairing radial meniscal tear; (2) to compare the biomechanical properties of the proposed repair techniques with the conventional double horizontal technique.
METHODS


Thirty-six fresh-frozen porcine medial menisci were randomly assigned into four groups and a complete tear was made at the midline of each meniscus. The menisci were subsequently repaired using four different repair techniques: double vertical (DV), double vertical cross (DVX), hybrid composing one vertical and one horizontal stitch, and conventional double horizontal (DH) suture technique with suturing parallel to the tibia plateau. The conventional double horizontal group was the control. The repaired menisci were subjected to cyclic loading followed by the load to failure testing. Gap formation and strength were measured, stiffness was calculated, and mode of failure was recorded.
RESULTS


Group differences in gap formation were not statistically significant at 100 cycles (p = .42), 300 cycles (p = .68), and 500 cycles (p = .70). A trend was found toward higher load to failure in DVX (276.8 N, p < .001), DV (241.5 N, p < .001), and Hybrid (237.6 N, p < .001) compared with DH (148.5 N). Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm). Tissue failure was the only failure mode observed in all specimens.
CONCLUSION


Our two proposed vertical suture techniques, as well as the double vertical technique, had superior biomechanical properties than the conventional technique as demonstrated by higher stiffness and higher strength.",2020,"Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm).","['Thirty-six fresh-frozen porcine medial menisci', 'repairing radial meniscus tear']","['repair techniques: double vertical (DV), double vertical cross (DVX), hybrid composing one vertical and one horizontal stitch, and conventional double horizontal (DH) suture technique with suturing parallel to the tibia plateau', 'vertical suture techniques']","['Gap formation and strength', 'gap formation', 'Tissue failure', 'DVX', 'DV', 'higher load to failure in DVX']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0743292,"Stiffness was also higher in DVX (60.7 N/mm, p < .001), DV (55.3 N/mm, p < .01), and Hybrid (52.1 N/mm, p < .01), than DH group (30.5 N/mm).","[{'ForeName': 'Guanqi', 'Initials': 'G', 'LastName': 'Hang', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore. hangguanqi@gmail.com.'}, {'ForeName': 'Andy Khye Soon', 'Initials': 'AKS', 'LastName': 'Yew', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Siaw Meng', 'Initials': 'SM', 'LastName': 'Chou', 'Affiliation': 'School of Mechanical & Aerospace Engineering, College of Engineering, Nanyang Technological University, 50 Nanyang Ave, Singapore, 639798, Singapore.'}, {'ForeName': 'Yoke Rung', 'Initials': 'YR', 'LastName': 'Wong', 'Affiliation': 'Department of Hand Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Shian Chao', 'Initials': 'SC', 'LastName': 'Tay', 'Affiliation': 'Department of Hand Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}, {'ForeName': 'Denny Tijauw Tjoen', 'Initials': 'DTT', 'LastName': 'Lie', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Singapore, 169865, Singapore.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00296-w']
2761,33025243,Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.,"PURPOSE


Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.
METHODS


Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms.
RESULTS


The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03-60.8). The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool ( https://cooksfa.z13.web.core.windows.net ).
CONCLUSIONS


This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES.
CLINICAL TRIAL REGISTRATIONS


Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837.
LEVELS OF EVIDENCE


Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.",2020,The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years.,"['patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions', '2227 patients']",['PTX RCT'],"['TLR', 'Probability of ffTLR', 'TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",2227.0,0.0408579,The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years.,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Dake', 'Affiliation': 'The University of Arizona, Health Sciences Innovation Building, 1670 East Drachman Street, 9th Floor SVP Suite, P.O. Box 210216, Tucson, AZ, 85721-0216, USA. mddake@email.arizona.edu.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'Department of Vascular and Interventional Radiology, ""Careggi"" University Hospital, Florence, Italy.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Lottes', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Leary"", 'Affiliation': 'Cook Research Incorporated, West Lafayette, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Reichert', 'Affiliation': 'EpidStrategies, Ann Arbor, MI, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'EpidStrategies, Ann Arbor, MI, USA.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zen', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schermerhorn', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'Universitaets-Herz-Zentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Ansel', 'Affiliation': 'Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus, OH, USA.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02648-6']
2762,33025252,The use of tamsulosin to prevent postoperative urinary retention in laparoscopic inguinal hernia repair: a randomized double-blind placebo-controlled study.,"PURPOSE


The rate of postoperative urinary retention (POUR) in laparoscopic inguinal hernia repairs is 1-22%. POUR may cause patient anxiety, discomfort, and increased hospital costs. Currently there is no standard prophylaxis for POUR. Preoperative administration of tamsulosin has been shown to decrease POUR rates in urologic studies. This study aims to evaluate the efficacy of tamsulosin on the incidence of POUR in patients undergoing totally extraperitoneal (TEP) LIHR.
METHODS


A randomized, double-blinded, placebo-controlled trial was initiated and accrued patients from 2017 to 2019. A total of 169 males undergoing elective TEP LIHR were included. Patients were administered tamsulosin 2 h before surgery and followed for up to 24 h postoperatively for episodes of POUR. Analysis was performed to quantify the association between patient, surgical, and perioperative factors with POUR.
RESULTS


The overall rate of POUR was 9%. There was no difference in the rate of POUR between the placebo (9.9%) and tamsulosin groups (7.9%) (p = 0.433). Univariate analysis showed a trend toward POUR in patients with history of benign prostatic hypertrophy (BPH) (p = 0.058). Previously reported risk factors of older age, total IVF, length of procedure and opioid use were not associated with increased rates of POUR. Tamsulosin reduced the time to discharge by 4 to 68 min when compared to placebo.
CONCLUSIONS


This study suggests that preoperative administration of tamsulosin may not reduce the risk of POUR in males undergoing elective TEP LIHR. Further study with a larger sample size may be needed to show a statistically significant difference.",2020,"Previously reported risk factors of older age, total IVF, length of procedure and opioid use were not associated with increased rates of POUR.","['males undergoing elective TEP LIHR', 'patients undergoing totally extraperitoneal (TEP) LIHR', '169 males undergoing elective TEP LIHR were included', 'patients from 2017 to 2019', 'laparoscopic inguinal hernia repair']","['tamsulosin', 'placebo', 'Tamsulosin']","['rate of postoperative urinary retention (POUR', 'POUR rates', 'overall rate of POUR', 'hospital costs', 'risk of POUR', 'incidence of POUR', 'time to discharge', 'rates of POUR', 'postoperative urinary retention', 'rate of POUR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",169.0,0.523468,"Previously reported risk factors of older age, total IVF, length of procedure and opioid use were not associated with increased rates of POUR.","[{'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Caparelli', 'Affiliation': 'Department of Surgery, Jewish Hospital of Cincinnati, 4777 E Galbraith Rd, Cincinnati, OH, 45236, USA. Mcaparelli@mercy.com.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Shikhman', 'Affiliation': 'Department of Surgery, Jewish Hospital of Cincinnati, 4777 E Galbraith Rd, Cincinnati, OH, 45236, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Runyan', 'Affiliation': 'Department of Surgery, Jewish Hospital of Cincinnati, 4777 E Galbraith Rd, Cincinnati, OH, 45236, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Allamaneni', 'Affiliation': 'Department of Surgery, Jewish Hospital of Cincinnati, 4777 E Galbraith Rd, Cincinnati, OH, 45236, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hobler', 'Affiliation': 'Department of Surgery, Jewish Hospital of Cincinnati, 4777 E Galbraith Rd, Cincinnati, OH, 45236, USA.'}]",Surgical endoscopy,['10.1007/s00464-020-08050-0']
2763,33025323,"A beat-by-beat cardiovascular index, CARDEAN, to titrate opioid administration in the setting of orthopaedic surgery: a prospective randomized trial.","To determine whether a beat-by-beat cardiovascular index (CARDEAN: cardiovascular depth of analgesia, Alpha-2 Ltd, Lyon, France) reduces the incidence of tachycardia in ASA I-III patients undergoing orthopaedic surgery. A total of 76 patients were prospectively randomized into (1) a control group or (2) the CARDEAN group, in which the nurse anaesthetist was blinded to CARDEAN application. In addition to conventional signs, an external observer instructed the nurse anaesthetist to administer sufentanil 0.1 µg kg -1  when the CARDEAN crossed a threshold (≥ 60). The primary outcome was the incidence of tachycardia (> 120% of reference heart rate, HR). Non-invasive blood pressure (BP), electrocardiogram (ECG), O 2  saturation-photoplethysmography and the bispectral index (40 < BIS < 60) were monitored. HR and an estimation of beat-by-beat BP changes acquired from photoplethysmography and ECG were combined in an algorithm that detected hypertension followed by tachycardia (index scaled 0-100). Sufentanil 0.1 µg kg -1  was administered when tachycardia, hypertension or movement (""conventional signs"") was observed. Data for 66 patients (27 with known hypertension) were analysed. In the CARDEAN group, (a) the dose of sufentanil was higher (control: 0.46 µg kg -1  100 min -1 , CARDEAN: 0.57 µg kg -1  100 min -1 , p = 0.016), (b) the incidence rates of tachycardia and untoward events were lower (respectively: - 44%; control: 2.52 events 100 min -1  [1.98-3.22]; CARDEAN: 1.42 [1.03-1.96], p = 0.005, hazard ratio: 0.56; movement, muscular contraction, or coughing: control: 0.74 events 100 min -1  [0.47-1.16]; CARDEAN: 0.31 [0.15-0.62], p = 0.038), and (c) extubation occurred more often in the operating room (control: 76.5%, CARDEAN: 97%, p = 0.016). CARDEAN-titrated opioid administration was associated with a higher dose of sufentanil, a reduction in tachycardia and earlier emergence in ASA I-III patients undergoing major orthopaedic surgery.",2020,"CARDEAN-titrated opioid administration was associated with a higher dose of sufentanil, a reduction in tachycardia and earlier emergence in ASA I-III patients undergoing major orthopaedic surgery.","['66 patients (27 with known hypertension', 'ASA I-III patients undergoing orthopaedic surgery', 'A total of 76 patients']","['sufentanil', 'Sufentanil']","['invasive blood pressure (BP), electrocardiogram (ECG), O 2  saturation-photoplethysmography and the bispectral index', 'incidence of tachycardia (>\xa0120% of reference heart rate, HR', 'incidence rates of tachycardia and untoward events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",76.0,0.0796588,"CARDEAN-titrated opioid administration was associated with a higher dose of sufentanil, a reduction in tachycardia and earlier emergence in ASA I-III patients undergoing major orthopaedic surgery.","[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Wey', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Loheas', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lamblin', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Riche', 'Affiliation': 'CNRS UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Biostatistique et Santé, Lyon, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rabilloud', 'Affiliation': 'CNRS UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Biostatistique et Santé, Lyon, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Escarment', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Puidupin', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Quintin', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France. lucquintinx@gmail.com.""}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Martinez', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Cividjian', 'Affiliation': ""Anaesthesia, Hôpital D'Instruction Des Armées Desgenettes, Lyon, France.""}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00597-6']
2764,33025342,"Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects.","INTRODUCTION


The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE).
METHODS


In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods.
RESULTS


Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo.
CONCLUSION


Concomitant administration of ozanimod with PSE, a sympathomimetic agent, did not potentiate the effects on blood pressure.
TRIAL REGISTRATION


NCT03644576.",2020,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"['56 healthy adult subjects', 'Fifty-two subjects (92.9%) completed the study', 'healthy subjects', 'Healthy Subjects']","['PSE', 'Pseudoephedrine', 'placebo or ozanimod', 'PSE 60\xa0mg was co-administered with placebo or ozanimod', 'placebo', 'ozanimod', 'pseudoephedrine (PSE', 'ozanimod with PSE']","['blood pressure', 'circulating total active drug exposure', 'PK of PSE', 'Maximum time-matched change in systolic blood pressure (SBP', 'Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE', 'tolerated', 'Mean maximum time-matched change from baseline for SBP']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0989419', 'cui_str': 'Pseudoephedrine 60 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",56.0,0.322654,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Apex Biostatistics, Inc, New Hill, NC, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Sciences, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Nonclinical Research and Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Translational Medicine, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01500-0']
2765,33025372,"Randomized controlled trial of a group intervention combining self-hypnosis and self-care: secondary results on self-esteem, emotional distress and regulation, and mindfulness in post-treatment cancer patients.","PURPOSE


Cancer patients often report low self-esteem and high emotional distress. Two factors seem particularly linked to these symptoms: emotion regulation strategies and mindfulness. The interest of hypnosis and self-care to relieve these symptoms is not well documented. Our randomized controlled trial aimed at assessing the effect of a group intervention combining self-hypnosis and self-care on self-esteem, emotional distress, emotion regulation, and mindfulness abilities of post-treatment cancer patients, as well as investigating the links between these variables.
METHODS


One hundred and four patients who had suffered from cancer were randomized into the intervention group (N = 52) and the wait-list control group (N = 52). They had to answer questionnaires before (T1) and after the intervention (T2). Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer. Group-by-time changes were assessed with MANOVA, and associations with self-esteem and emotional distress were investigated with hierarchical linear regression models.
RESULTS


Participants in the intervention group (mean age = 51.65; SD = 12.54) reported better self-esteem, lower emotional distress, a decreased use of maladaptive emotion regulation strategies, and more mindfulness abilities after the intervention, compared to the WLCG. This increase in mindfulness explained 33% of the improvement of self-esteem and 41.6% of the decrease of emotional distress in the intervention group. Self-esteem and emotional distress also predicted each other.
CONCLUSION


Our study showed the efficacy of our hypnosis-based intervention to improve all the investigated variables. Mindfulness predicted the improvement of self-esteem and emotional distress. The primary impact of our intervention on mindfulness abilities seems to explain, at least in part, its efficacy. Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.",2020,Mindfulness predicted the improvement of self-esteem and emotional distress.,"['post-treatment cancer patients', 'Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer', 'Cancer patients often report low self-esteem and high emotional distress', 'One hundred and four patients who had suffered from cancer']",['group intervention combining self-hypnosis and self-care'],"['better self-esteem, lower emotional distress', 'self-esteem', 'emotional distress', 'self-esteem, emotional distress and regulation, and mindfulness', 'mindfulness abilities', 'maladaptive emotion regulation strategies', 'self-esteem, emotional distress, emotion regulation, and mindfulness abilities', 'Self-esteem and emotional distress', 'self-esteem and emotional distress']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C2712312', 'cui_str': 'High self-esteem'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",95.0,0.0485733,Mindfulness predicted the improvement of self-esteem and emotional distress.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grégoire', 'Affiliation': 'Faculty of Psychology, Speech Therapy and Educational Sciences, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium. ch.gregoire@chuliege.be.'}, {'ForeName': 'M-E', 'Initials': 'ME', 'LastName': 'Faymonville', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vanhaudenhuyse', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'Medical Oncology Department, CHU Liège and University of Liège, Liège, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Faculty of Psychology, Speech Therapy and Educational Sciences, University of Liège, Liège, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bragard', 'Affiliation': 'Haute Ecole Libre Mosane (HELMo), Liège, Belgium.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02655-7']
2766,33025616,"Efficacy of a novel extract of fenugreek seeds in alleviating vasomotor symptoms and depression in perimenopausal women: A randomized, double-blinded, placebo-controlled study.","The present randomized, double-blinded, placebo-controlled study investigated the effect of a standardized fenugreek extract (FHE) on perimenopausal discomforts and its influence on hormonal balance and safety. Healthy women characterized with perimenopausal symptoms (n = 48), as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%). Further hormone analysis revealed an enhancement in serum estradiol (18.9%), free testosterone (38.2%), and progesterone (19.9%) concentrations and a significant decrease in FSH (38.2%) and SHBG (21.1%) concentrations toward establishing a hormonal balance among FHE-group; without significant changes in other clinical safety parameters. Thus, FHE supplementation offered a significant reduction in vasomotor effects and depression in perimenopausal women, without any adverse effects PRACTICAL APPLICATIONS: Fenugreek is a popular kitchen spice and Ayurvedic medicine for a variety of health conditions including diabetes, hypercholesterolemia, hepatotoxicity, gastritis, and also for a variety of hormone-related health conditions such as sexual functions, lactation, osteoporosis, PCOS, and post/perimenopausal discomforts. Fenugreek is rich in alkaloids, steroidal saponins, flavonoids and 4-hydroxyisoleucine. The present randomized-controlled study investigated the plausible application of a standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline in the management of perimenopausal discomforts. It was observed that FHE at a dosage of 250 mg × 2/day for 42 days significantly reduced the discomforts, especially vasomotor symptoms and depression, and helped to attain a hormonal balance without any adverse effects or deviations in clinical safety parameters. Thus, FHE could be a potential natural agent for the management of post and perimenopausal discomforts and has to be explored in future studies.",2020,"Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%).","['perimenopausal women', 'Healthy women characterized with perimenopausal symptoms (n\xa0=\xa048), as assessed by MRS questionnaire']","['FHE supplementation', 'standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline', 'FHE', 'standardized fenugreek extract (FHE', 'FHE ', 'novel extract of fenugreek seeds', 'placebo']","['hormonal balance and safety', 'serum estradiol', 'vasomotor effects and depression', 'insomnia', 'vasomotor symptoms and depression', 'night sweats', 'somatic, psychological, and urogenital scores', 'free testosterone', 'depression', 'SHBG', 'FSH']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0949062', 'cui_str': 'Perimenopausal symptoms'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453257', 'cui_str': 'Fenugreek seed'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1137520', 'cui_str': 'protodioscin'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}, {'cui': 'C0060207', 'cui_str': 'Fenugreek'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}]",,0.230823,"Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%).","[{'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Aman Hospital and Research Center, Vadodara, Gujarat, India.'}, {'ForeName': 'Febi', 'Initials': 'F', 'LastName': 'John', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Syam', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Jestin', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research and Bio Services Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Leads Clinical Research and Bio Services Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Maliakel', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': 'Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}]",Journal of food biochemistry,['10.1111/jfbc.13507']
2767,33025645,Comparison of 6-mm and 11-mm dental implants in the posterior region supporting fixed dental prostheses; 5-year results of an open multi-center randomized controlled trial.,"OBJECTIVE


The aim of this multi-center, randomized controlled trial was to compare the clinical and radiographic outcomes of 6-mm or 11-mm implants, placed in the posterior maxilla and mandible, during a 5-years follow-up period.
MATERIALS AND METHODS


Ninety-five patients with adequate bone height for 11-mm implants, were randomly allocated to a 6-mm group (test group with short implants) or an 11-mm group (control group with standard length implants). Two or three implants of the same length were placed in each patient and after 6 weeks loaded with a splinted provisional restoration. This was followed by definitive splinted restoration 6 months after implant placement. Clinical and radiographic parameters, including the occurrence of complications were recorded.
RESULTS


A total of 49 patients were enrolled to receive 6-mm implants (n = 108) and 46 patients to receive 11-mm implants (n = 101). Three implants (two of 6 mm and one of 11 mm in length) were lost before loading and one 6-mm implant after 15 months of function, and one 11-mm implant was lost during the first year of function. The 5-year survival rates were 96.0% and 98.9% in the 6-mm and 11-mm group, respectively. The mean marginal bone level changes 5 years post-loading were 0.01 ± 0.45 mm (bone gain) in the 6-mm group and -0.12 ± 0.93 mm (bone loss) in the 11-mm group (p = .7670). Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
CONCLUSION


The clinical and radiographic outcomes of 6-mm short and 11-mm standard-length implants were not different during a 5-year evaluation period.",2020,"Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
","['49 patients were enrolled to receive 6-mm implants (n\xa0=\xa0108) and 46 patients to receive 11-mm implants (n\xa0=\xa0101', 'Ninety-five patients with adequate bone height for 11-mm implants']","['6-mm group (test group with short implants) or an 11-mm group (control group with standard length implants', '6-mm short and 11-mm standard-length implants']","['technical complications', '5-year survival rates', 'mean marginal bone level changes', 'plaque, bleeding on probing and pocket probing depth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",49.0,0.13408,"Clinical parameters, including plaque, bleeding on probing and pocket probing depth were not significantly different between the groups, and also technical complications were low.
","[{'ForeName': 'Felix L', 'Initials': 'FL', 'LastName': 'Guljé', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery, Groningen, the Netherlands and Center for Dental Implants, Apeldoorn, the Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Oral and Maxillofacial Surgery and Department of Implant Dentistry, Groningen, the Netherlands.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Palmer', 'Affiliation': ""King's College London Dental Institute at Guy's King's and St Thomas' Hospitals, London, United Kingdom.""}, {'ForeName': 'Ingemar', 'Initials': 'I', 'LastName': 'Abrahamsson', 'Affiliation': 'University of Gothenburg, The Sahlgrenska Academy, Department of Periodontology, Gothenburg, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'University of Melbourne, School of Dental Science, Department of Periodontics, Melbourne, Vic, Australia.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Zadeh', 'Affiliation': 'VISTA Institute for Therapeutic Innovations, CA, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Barwacz', 'Affiliation': 'University of Iowa College of Dentistry & Dental Clinics, Department of Family Dentistry, Iowa City, Iowa, USA.'}, {'ForeName': 'Clark M', 'Initials': 'CM', 'LastName': 'Stanford', 'Affiliation': 'University of Illinois at Chicago, Department of Restorative Dentistry, Chicago, IL, USA.'}]",Clinical oral implants research,['10.1111/clr.13674']
2768,33025648,A randomized controlled trial with a delayed-type hypersensitivity model using keyhole limpet haemocyanin to evaluate adaptive immune responses in man.,"AIM


Keyhole limpet haemocyanin (KLH) immunization is a clinical model for the evaluation of human antibody responses. The current study evaluated the anti-KLH antibody response after KLH immunization and the delayed-type hypersensitivity (DTH) response following intradermal KLH administration, using objective imaging techniques.
METHODS


Healthy male subjects, aged 24.5 ± 5.4 years were randomized to intramuscular immunization with 100 μg KLH (n=12) or placebo (n=3). Anti-KLH antibody M (IgM) and IgG titres were determined before and every 7 days after KLH immunization for a total of 28 days. Twenty-one days after the immunization, all subjects received 1 μg KLH intradermally. Prior to and 2 days after intradermal KLH administration, skin blood perfusion, erythema and oedema were quantified using non-invasive imaging tools. Repeated measures ANCOVAs were used to analyse data.
RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference (ED): 37%, 95% confidence interval (CI): 19%-51% and ED: 68%, 95% CI: 56%-76% respectively). Upon intradermal KLH administration an increase in skin blood perfusion (ED: 10.9 arbitrary units (AU), 95% CI: 1.4-20.4 AU) and erythema (ED: 0.3 AU, 95% CI: 0.1-0.5 AU) was observed in KLH immunized subjects compared to placebo.
CONCLUSION


KLH immunization followed by intradermal KLH administration resulted in increased anti-KLH IgM and IgG titres and a DTH response quantified by an increase in skin blood perfusion and erythema. Using non-invasive imaging tools the KLH model has the potential to serve as an objective tool to study the pharmacodynamics of T-cell-directed immunomodulatory drugs.",2020,"RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference (ED): 37%, 95% confidence interval (CI): 19%-51% and ED: 68%, 95% CI: 56%-76% respectively).","['man', 'Healthy male subjects, aged 24.5 ± 5.4 years']","['KLH', 'intramuscular immunization with 100 μg KLH', 'placebo', 'delayed-type hypersensitivity model using keyhole limpet haemocyanin', 'Keyhole limpet haemocyanin (KLH) immunization']","['skin blood perfusion, erythema and oedema', 'Anti-KLH IgM and IgG titres', 'erythema (ED', 'skin blood perfusion and erythema', 'Anti-KLH antibody M (IgM) and IgG titres', 'delayed-type hypersensitivity (DTH) response', 'anti-KLH IgM and IgG titres and a DTH response', 'skin blood perfusion']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0064332', 'cui_str': 'Keyhole-limpet hemocyanin'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.107235,"RESULTS


Anti-KLH IgM and IgG titres increased after KLH immunization compared to placebo (estimated difference (ED): 37%, 95% confidence interval (CI): 19%-51% and ED: 68%, 95% CI: 56%-76% respectively).","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Saghari', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Gal', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ziagkos', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Powell', 'Affiliation': 'Kymab Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Brennan', 'Affiliation': 'Kymab Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Department of Dermatology Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14588']
2769,33025656,Impact of lipid levels and high-intensity statins on vein graft patency after CABG: Midterm results of the ACTIVE trial.,"BACKGROUND


High-dose atorvastatin did not improve 1-year vein graft patency in the recent Aggressive Cholesterol Therapy to Inhibit Vein Graft Events trial. However, it remains unknown whether high-intensity statins may impact graft disease in the years that follow.
METHODS


In the trial, patients (N = 173) were randomized to receive atorvastatin 10 or 80 mg for 1 year after coronary bypass surgery (CABG). Beyond 1 year, the choice of statin was left to the patient's physician. In this study of participants who agreed to follow-up (N = 76), low-density lipoprotein (LDL) levels were measured and graft patency was assessed 3 years after surgery.
RESULTS


The rate of vein graft disease 3 years after surgery was not significantly reduced with atorvastatin 80 mg during the first postoperative year or the use of open-label high-intensity statin thereafter (p = NS). However, a trend was observed between higher LDL levels during the first postoperative year and a greater incidence of vein graft disease at 3 years (p = .12). Among patients who had LDL levels more than 90 mg/dl in the first year after CABG, 38.5% had vein graft disease at 3 years, compared to 19.0% for those with LDL levels less than 90 mg/dl (p = .15). Higher mean LDL levels during the first postoperative year were associated with a higher rate of vein disease 3 years after surgery both at the graft level (p = .03) and at the patient level (p = .03) in multivariate analysis.
CONCLUSIONS


Higher LDL levels during the first postoperative year were associated with significantly greater vein graft disease 3 years after CABG.",2020,The rate of vein graft disease 3 years after surgery was not significantly reduced with atorvastatin 80 mg during the first postoperative year or the use of open-label high-intensity statin thereafter (p = NS).,"['vein graft patency after CABG', 'participants who agreed to follow-up (N\u2009=\u200976', 'patients (N\u2009=\u2009173']","['lipid levels and high-intensity statins', 'atorvastatin 10 or 80\u2009mg for 1 year after coronary bypass surgery (CABG', 'atorvastatin']","['1-year vein graft patency', 'mean LDL levels', 'rate of vein graft disease 3 years after surgery', 'incidence of vein graft disease', 'higher LDL levels', 'LDL levels', 'low-density lipoprotein (LDL) levels', 'vein graft disease']","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}]",173.0,0.105674,The rate of vein graft disease 3 years after surgery was not significantly reduced with atorvastatin 80 mg during the first postoperative year or the use of open-label high-intensity statin thereafter (p = NS).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kulik', 'Affiliation': 'Division of Cardiac Surgery, Boca Raton Regional Hospital, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Abreu', 'Affiliation': 'Division of Cardiac Surgery, Boca Raton Regional Hospital, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Boronat', 'Affiliation': 'Division of Cardiac Surgery, Boca Raton Regional Hospital, Florida Atlantic University, Boca Raton, Florida, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, The University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}]",Journal of cardiac surgery,['10.1111/jocs.15014']
2770,33025690,Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients with Acute Sickle Cell Crises?,"Study objective We evaluated the ability of intravenous (IV) acetaminophen to reduce the amount of opioid medication administered in pediatric patients with sickle cell disease (SCD) having vaso-occlusive crisis (VOC) in an emergency department (ED) setting.
METHODS


This was a prospective, randomized, double-blind placebo-controlled trial at an academic urban pediatric ED. Participants included patients with SCD, aged 4-16 years, with VOC pain. All patients received 0.1 mg/kg dose of IV morphine, 0.5 mg/kg ketorolac, or both. Patients were randomized to receive either 15 mg/kg of IV acetaminophen or placebo. Patients were reassessed every 30 minutes to see if additional opioid doses were indicated to a maximum of 3 doses. The total morphine given, pain scores, rates of admissions, 72-hour return visits, and adverse events were assessed for each group.
RESULTS


Of 71 subjects randomized, 35 patients in the acetaminophen group and 36 patients in the control group were analyzed. Baseline characteristics and initial pain scores were similar in both groups. The mean total amount morphine given was 8.6 mg (95% CI 6.5-10.8) in the acetaminophen group and 8.0 mg (95% CI 5.9 - 10.2) in the placebo group. The mean total cumulative morphine dosing was 0.2 mg/kg (95% CI 0.1-0.2) in the acetaminophen group and 0.2 mg/kg (95% CI 0.1-0.2) in the control group. The mean pain score at time of disposition was 5.5 (95% CI 4.3 - 6.6) in the acetaminophen group and 5.2 (95%CI 4.2 - 6.3) in the placebo group. There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
CONCLUSION


In this study, patients who received IV acetaminophen did not receive less morphine than patients in the placebo group. Disposition pain scores for the 2 groups were also equivalent. We conclude that IV acetaminophen, when used in addition to morphine for pediatric sickle cell VOC pain, does not provide an opioid sparing effect. Further searches for adjunctive non-addictive pain medicines are indicated.",2020,"There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
","['academic urban pediatric ED', 'pediatric patients with sickle cell disease (SCD) having vaso-occlusive crisis (VOC) in an emergency department (ED) setting', '71 subjects randomized, 35 patients in the', 'Pediatric Emergency Department Patients with Acute Sickle Cell Crises', 'pediatric sickle cell VOC pain', 'Participants included patients with SCD, aged 4-16 years, with VOC pain']","['acetaminophen', 'Acetaminophen', 'acetaminophen or placebo', 'placebo', 'intravenous (IV) acetaminophen', 'morphine', 'IV morphine, 0.5 mg/kg ketorolac']","['Baseline characteristics and initial pain scores', 'rates of admission, 72-hour return visits, or adverse events', 'mean total cumulative morphine', 'mean total amount morphine', 'total morphine given, pain scores, rates of admissions, 72-hour return visits, and adverse events', 'mean pain score at time of disposition', 'Disposition pain scores']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0238425', 'cui_str': 'Hemoglobin SS disease with crisis'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}]",71.0,0.589693,"There were no clinical or statistically significant differences between the rates of admission, 72-hour return visits, or adverse events.
","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Dhebaria', 'Affiliation': ""Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sivitz', 'Affiliation': ""Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}, {'ForeName': 'Cena', 'Initials': 'C', 'LastName': 'Tejani', 'Affiliation': ""Pediatric Emergency Department, Children's Hospital of New Jersey at Newark Beth Israel Medical Center, Newark, NJ, USA.""}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14149']
2771,33025749,Holmium laser enucleation of the prostate using Moses 2.0 vs non-Moses. A randomized controlled trial.,"OBJECTIVES


To compare the enucleation efficiency of Moses 2.0 with non-Moses technology in patients undergoing Laser enucleation of the prostate (HoLEP).
PATIENTS AND METHODS


A double-blinded, randomized study of patients undergoing HoLEP at Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system. Patients were randomized to either right lobe enucleation using Moses 2.0 and left lobe enucleation using non-Moses, or the opposite. The primary outcome was individual lobe enucleation efficiency. Secondary outcomes included individual lobe laser time, laser energy, individual enucleation and hemostasis laser energies, and fiber burn back. Two independent reviewers watched videos of the procedures and provided a subjective evaluation of the technologies.
RESULTS


Twenty-seven patients were included in the study. For the entire cohort, Moses 2.0 had less fiber degradation (3.5 vs 16.8 mm, p<0.01) compared to non-Moses. When HOLEP procedures were performed by an expert, Moses 2.0 resulted in shorter enucleation time (21 vs 36.7 mins, p=0.016) and higher enucleation efficiency (1.75 vs 1.05 gm/min, p=0.05) compared to non-Moses. When HoLEP was performed by trainees, the Moses 2.0 cohort had a shorter hemostasis laser time (4.1 vs 9 minutes, p=0.035) compared to the non-Moses. Fiber degradation was lower with Moses 2.0 compared to non-Moses in both experts and trainees. Moses 2.0 received higher score than the standard technology with respect to the incision sharpness, fiber control, tissue separation, tissue damage, hemostasis, visibility, and Charring. The overall interobserver correlation coefficient was 0.63.
CONCLUSION


Moses 2.0 has higher enucleation efficiency compared to non-Moses when used by experts. The subjective evaluation favored Moses 2.0.",2020,"Moses 2.0 received higher score than the standard technology with respect to the incision sharpness, fiber control, tissue separation, tissue damage, hemostasis, visibility, and Charring.","['patients undergoing Laser enucleation of the prostate (HoLEP', 'patients undergoing HoLEP at Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system', 'Twenty-seven patients were included in the study']","['right lobe enucleation using Moses 2.0 and left lobe enucleation using non-Moses, or the opposite', 'Holmium laser enucleation']","['higher enucleation efficiency', 'shorter hemostasis laser time', 'enucleation efficiency', 'fiber degradation', 'individual lobe laser time, laser energy, individual enucleation and hemostasis laser energies, and fiber burn back', 'shorter enucleation time', 'individual lobe enucleation efficiency', 'Fiber degradation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1293635', 'cui_str': 'Laser enucleation of the prostate'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C3873738', 'cui_str': 'Laser system'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0227481', 'cui_str': 'Structure of right lobe of liver'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}]",27.0,0.041238,"Moses 2.0 received higher score than the standard technology with respect to the incision sharpness, fiber control, tissue separation, tissue damage, hemostasis, visibility, and Charring.","[{'ForeName': 'Amihay', 'Initials': 'A', 'LastName': 'Nevo', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}, {'ForeName': 'Kassem S', 'Initials': 'KS', 'LastName': 'Faraj', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Cheney', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Moore', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Stern', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borofsky', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Gnessin', 'Affiliation': ""Department of Urology, Shamir medical center, Be'er Ya'akov, Israel.""}, {'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Humphreys', 'Affiliation': 'Department of Urology, Mayo Clinic in Arizona, Arizona, USA.'}]",BJU international,['10.1111/bju.15265']
2772,33025835,Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial.,"This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional module in evidence-based parent training and whether the added module might detract from the efficacy of the original program. In a cluster randomized trial, six community-based organizations were randomized to deliver Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT as usual (PAT-AU). CSA-related awareness and protective behaviors, as well as general parenting behaviors taught by PAT were assessed at baseline, post-PAT, post-SPSHK, and 1-month follow-up. Multilevel analyses revealed significant group by time interactions for both awareness and behaviors ( ps <  .0001), indicating the PAT+SPSHK group had significantly greater awareness of CSA and used protective behaviors more often (which were maintained at follow-up) compared to the PAT-AU group. No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed. Results indicate adding SPHSK to existing parent training can significantly enhance parents' awareness of and readiness to engage in protective behavioral strategies. Implementing SPHSK as a selective prevention strategy with at-risk parents receiving parent training through child welfare infrastructures is discussed.",2020,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"['child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK']","['Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT', 'PAT+SPSHK']","['CSA-related awareness and protective behaviors', 'awareness of CSA and used protective behaviors']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",6.0,0.0313322,No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed.,"[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Guastaferro', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Felt', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Font', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Connell', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Sheridan', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Zadzora', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Jennie G', 'Initials': 'JG', 'LastName': 'Noll', 'Affiliation': 'The 8082Pennsylvania State University, State College, PA, USA.'}]",Child maltreatment,['10.1177/1077559520963870']
2773,33025843,Efficacy of Combination Neoadjuvant Chemotherapy and Regional Inductive Moderate Hyperthermia in the Treatment of Patients With Locally Advanced Breast Cancer.,"PURPOSE


To evaluate the efficacy of neoadjuvant chemotherapy in combination with regional inductive moderate hyperthermia for patients with locally advanced breast cancer.
PATIENTS AND METHODS


200 patients with stage IIB-IIIA breast cancer received neoadjuvant chemotherapy (control group, n = 97) or chemotherapy combined with hyperthermia (experimental group, n = 103). Inductive hyperthermia was set at 27.12 ± 0.16 MHz and the 50 W output power.
RESULTS


Thermal and color Doppler ultrasound imaging demonstrated that hyperthermia increased the surface temperature on the breasts to < 4°С while the mean values for systolic blood flow were 3.5 times as high as those prior to treatment. Assessment of tumor size and response found a (31.24 ± 3.85)% reduction in the size of the primary tumor in patients receiving chemotherapy + hyperthermia, while chemotherapy alone showed a (22.95 ± 3.61)% decrease on average (p = 0.034). The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group. The patients in the experimental group also had axillary lymph node regression of 14.17% greater than in the control group (p = 0.011). Moreover, the combination treatment allowed to increase the proportion of women eligible for breast-conserving and reconstructive surgery by 13.63% in the experimental group. The viable tumor volume was lower in patients receiving neoadjuvant chemotherapy + hyperthermia (24.4 ± 0.2)% compared with those given chemotherapy alone (30.4 ± 0.25)%. The 10-year overall survival rates were higher (log-rank: p = 0.009) in breast cancer patients who underwent chemotherapy combined with hyperthermia than in patients receiving chemotherapy only.
CONCLUSION


The combination neoadjuvant chemotherapy and the technology of regional inductive moderate hyperthermia improved the efficacy of treatment for patients with locally advanced breast cancer staged IIB-IIIA.",2020,The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group.,"['patients with locally advanced breast cancer', 'Patients With Locally Advanced Breast Cancer', 'patients with locally advanced breast cancer staged IIB-IIIA', '200 patients with stage IIB-IIIA breast cancer received']","['chemotherapy combined with hyperthermia', 'neoadjuvant chemotherapy (control group, n = 97) or chemotherapy combined with hyperthermia', 'neoadjuvant chemotherapy', 'Combination Neoadjuvant Chemotherapy and Regional Inductive Moderate Hyperthermia']","['proportion of women eligible for breast-conserving and reconstructive surgery', 'surface temperature', 'systolic blood flow', '10-year overall survival rates', 'rate of objective response', 'viable tumor volume', 'axillary lymph node regression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}]",200.0,0.0239746,The rate of objective response increased by 15.9% in the experimental group (р = 0.034) compared with the control group.,"[{'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Loboda', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Smolanka', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Valerii E', 'Initials': 'VE', 'LastName': 'Orel', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Syvak', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Golovko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Dosenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Lyashenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Smolanka', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Olha', 'Initials': 'O', 'LastName': 'Dasyukevich', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Tarasenko', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Valerii B', 'Initials': 'VB', 'LastName': 'Orel', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rykhalskyi', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Ganich', 'Affiliation': 'National Cancer Institute, Kyiv, Ukraine.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Mokhonko', 'Affiliation': 'Biomedical Engineering Department, ""Igor Sikorsky Kyiv Polytechnic Institute,"" Kyiv, Ukraine.'}]",Technology in cancer research & treatment,['10.1177/1533033820963599']
2774,33025865,Corrigendum to A Randomized Controlled Trial to Determine the Appropriate Time to Initiate Peritoneal Dialysis after Insertion of Catheter (Timely PD Study).,,2020,,[],[],[],[],[],[],,0.123289,,[],Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.1177/0896860820965405']
2775,33025883,"Effect of caffeinated and decaffeinated coffee on serum uric acid and uric acid clearance, a randomised within-subject experimental study.","OBJECTIVES


The effect of coffee on serum uric acid (SUA) has shown conflicting results. This study was to determine the effects of caffeinated coffee (CC) and decaffeinated coffee (DC) on SUA, serum xanthine oxidase activity (sXOA) and urine uric acid clearance (UAC).
METHODS


This was a prospective randomised within-subject experimental study design of 51 healthy male participants. Each study period consisted of 3 periods, including a control, an intervention, and washout period for 1, 3 and 1 week, respectively. During the intervention period, the participants received 2, 4 or 6 gram/day of coffee, either CC or DC.
RESULTS


For DC groups, SUA significantly decreased by 6.5 (±1.1) mg/dL to 6.2 (±1.1) mg/dL during the intervention period (p=0.014). sXOA significantly increased by 0.05 (±0.07) nmol/min/mL to 0.20 (±0.38) nmol/min/mL during the intervention period (p=0.010) of CC. For UAC, there was no significant change with CC or DC. In hyperuricaemic participants, SUA significantly decreased by 7.7 (±0.7) mg/dL to 7.2 (±0.7) mg/dL during the intervention period (p=0.028) of DC. For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period. A significant increase of sXOA according with SUA in CC groups from 0.05 (±0.07) nmol/min/mL to 0.25 (±0.44) nmol/min/mL during the intervention period (p=0.040) was presented in non-hyperuricaemic participants.
CONCLUSIONS


DC had a significant decrease of SUA during the intervention period. However, in non-HUS participants, SUA significantly increased in CC.",2020,"For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period.",['51 healthy male participants'],"['caffeinated and decaffeinated coffee', 'caffeinated coffee (CC) and decaffeinated coffee (DC']","['sXOA', 'SUA, serum xanthine oxidase activity (sXOA) and urine uric acid clearance (UAC', 'SUA', 'serum uric acid and uric acid clearance']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0428286', 'cui_str': 'Urine urate measurement'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",51.0,0.0143496,"For non-hyperuricaemic, CC significantly increased SUA by 5.9 (±0.7) mg/dL to 6.2 (±0.9) mg/dL during the intervention period (p=0.008) and significantly decreased SUA to 6.0 (±0.8) mg/dL (p=0.049) during the withdrawal period.","[{'ForeName': 'Patapong', 'Initials': 'P', 'LastName': 'Towiwat', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Naresuan University, Thailand. puidulian@gmail.com.'}, {'ForeName': 'Anothai', 'Initials': 'A', 'LastName': 'Tangsumranjit', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Thailand.'}, {'ForeName': 'Kornkanok', 'Initials': 'K', 'LastName': 'Ingkaninan', 'Affiliation': 'Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University, Thailand.'}, {'ForeName': 'Katechan', 'Initials': 'K', 'LastName': 'Jampachaisri', 'Affiliation': 'Department of Mathematics, Faculty of Science, Naresuan University, Thailand.'}, {'ForeName': 'Nattiya', 'Initials': 'N', 'LastName': 'Chaichamnong', 'Affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Public Health, Naresuan University, Thailand.'}, {'ForeName': 'Bodin', 'Initials': 'B', 'LastName': 'Buttham', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Naresuan University, Thailand.'}, {'ForeName': 'Bodin', 'Initials': 'B', 'LastName': 'Buttham', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Naresuan University, Thailand.'}, {'ForeName': 'Worawit', 'Initials': 'W', 'LastName': 'Louthrenoo', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Thailand.'}]",Clinical and experimental rheumatology,[]
2776,33025926,Auto-controlled Syringe vs Insulin Syringe for Palatal Injections in Children: A Randomized Crossover Trial.,"AIM


This study aims to evaluate and compare the efficacy of auto-control syringe (ACS) and insulin syringe (IS) for palatal local anesthesia administration in children.
MATERIALS AND METHODS


The study was a double-blind, randomized, and crossover trial, comprising 80 children requiring palatal anesthesia bilaterally (total 160 injections). Palatal anesthesia on one side was delivered with ACS in one appointment and contralaterally with IS in the second appointment. One-week washout period was given between first and second appointments. Each child acted as his own control. Each injection technique subjective and objective pain scores were measured twice (during needle prick and during actual deposition of local anesthesia). Subjective and objective evaluation of pain was measured with Wong-Baker FACES pain rating scale (WB-FPS) and the face, leg, activity, cry, and consolability scale (FLACC), respectively. After concluding second appointment, child was asked about their preference between both ACS and IS. Statistical evaluation was performed using Chi-square test.
RESULTS


Child reported less pain score for needle prick with IS as opposed to ACS ( p  value = 0.000416). There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration. There is no significant difference between child reported pain score during administration of local anesthesia between two groups. Irrespective of pain scores, most of the children (96.5%) preferred IS.
CONCLUSION


For palatal local anesthesia administration in children, both IS and auto-controlled syringe have similar efficacy.
CLINICAL SIGNIFICANCE


Insulin syringe can serve as an economical alternative to the expensive auto-controlled syringe for palatal injections in children.",2020,There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration.,"['children', 'Children', '80 children requiring palatal anesthesia bilaterally (total 160 injections']","['Auto-controlled Syringe vs Insulin Syringe', 'auto-control syringe (ACS) and insulin syringe (IS']","['objective pain scores', 'pain score', 'Subjective and objective evaluation of pain', 'Baker FACES pain rating scale (WB-FPS) and the face, leg, activity, cry, and consolability scale (FLACC', 'pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4285979', 'cui_str': 'Palatal anaesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}]",80.0,0.0630243,There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration.,"[{'ForeName': 'Sunny Priyatham', 'Initials': 'SP', 'LastName': 'Tirupathi', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India, e-mail: dr.priyatham@gmail.com.'}, {'ForeName': 'Srinitya', 'Initials': 'S', 'LastName': 'Rajasekhar', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Pushpalatha', 'Initials': 'P', 'LastName': 'Tummakomma', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Aishwarya Arya', 'Initials': 'AA', 'LastName': 'Gangili', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Abdul Rehman Ahmed', 'Initials': 'ARA', 'LastName': 'Khan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Majmaah University, College of Dentistry, Al Zulfi, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Khurramuddin', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Purumandla', 'Affiliation': 'Department of Periodontics, Malla Reddy Institute of Dental Sciences, Hyderabad, Telangana, India.'}]",The journal of contemporary dental practice,[]
2777,33017450,Origami folding: Taxing resources necessary for the acquisition of sequential skills.,"Sequential skill learning with practice is fundamental to human activity (e.g., tying shoes). Given the lack of prior knowledge in most participants, Origami folding is a promising task to study the acquisition of a sequential skill. While previous Origami folding studies mainly dealt with the question, which forms of instruction can lead to better learning outcomes, we employ a dual-task approach to test which resources are necessary for folding and for improvement with practice. Participants (N = 53) folded five Origami figures for four times each, which were randomly paired with five types of secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition). Origami performance showed a typical learning curve from Trial 1 (first run of folding the figure) to Trial 4 (fourth run of folding the same figure). We tested for a dissociation between variants of memory load influencing Origami folding performance vs. the variants influencing learning (i.e. change in performance across practice). In line with theories suggesting that learning operates on the level that (at a given point in practice) demands the most control, we did not observe cases where a dual-task variant influenced performance while it did not affect learning. Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice. This might be due to the use of visuospatial sketchpad and absolute timing mechanism during the acquisition of Origami folding.",2020,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,[],['secondary tasks to cause either cognitive (verbal vs. visuospatial) or motoric (isochronous vs. non-isochronous tapping) memory load or none (control condition'],['Origami performance'],[],"[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],53.0,0.0243564,Memory load from the cognitive visuospatial secondary task as well as the isochronous tapping secondary task interfered with improvement in Origami folding with practice.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gaschler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Kneschke', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Radler', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gausmann', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Duttine', 'Affiliation': 'Department of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Haider', 'Affiliation': 'Department of Psychology, University of Cologne, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0240226']
2778,33017456,"Effect of a 90 g/day low-carbohydrate diet on glycaemic control, small, dense low-density lipoprotein and carotid intima-media thickness in type 2 diabetic patients: An 18-month randomised controlled trial.","AIM


This study explored the effect of a moderate (90 g/d) low-carbohydrate diet (LCD) in type 2 diabetes patients over 18 months.
METHODS


Ninety-two poorly controlled type 2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months were randomly assigned to a 90 g/d LCD r traditional diabetic diet (TDD). The primary outcomes were glycaemic control status and change in medication effect score (MES). The secondary outcomes were lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT).
RESULTS


A total of 85 (92.4%) patients completed 18 months of the trial. At the end of the study, the LCD and TDD group consumed 88.0±29.9 g and 151.1±29.8 g of carbohydrates, respectively (p < 0.05). The 18-month mean change from baseline was statistically significant for the HbA1c (-1.6±0.3 vs. -1.0±0.3%), 2-h glucose (-94.4±20.8 vs. -18.7±25.7 mg/dl), MES (-0.42±0.32 vs. -0.05±0.24), weight (-2.8±1.8 vs. -0.7±0.7 kg), waist circumference (-5.7±2.7 vs. -1.9±1.4 cm), hip circumference (-6.1±1.8 vs. -2.9±1.7 cm) and blood pressure (-8.3±4.6/-5.0±3 vs. 1.6±0.5/2.5±1.6 mmHg) between the LCD and TDD groups (p<0.05). The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
CONCLUSIONS


A moderate (90 g/d) LCD showed better glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT than TDD for type 2 diabetic patients.",2020,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","['type 2 diabetic patients', 'type 2 diabetes patients over 18 months', 'Ninety-two poorly controlled type', '2 diabetes patients aged 20-80 years with HbA1c ≥7.5% (58 mmol/mol) in the previous three months']","['90 g/day low-carbohydrate diet', 'LCD r traditional diabetic diet (TDD', 'moderate (90 g/d) low-carbohydrate diet (LCD']","['weight', 'glycaemic control status and change in medication effect score (MES', 'blood pressure', 'lipid profiles, small, dense low-density lipoprotein (sdLDL), serum creatinine, microalbuminuria and carotid intima-media thickness (IMT', 'glycaemic control with decreasing MES, lowering blood pressure, decreasing weight, waist and hip circumference without adverse effects on lipid profiles, sdLDL, serum creatinine, microalbuminuria, ALT and carotid IMT', 'waist circumference', 'lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT', 'hip circumference', '2-h glucose', 'MES']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.106199,"The 18-month mean change from baseline was not significantly different in lipid profiles, sdLDL, serum creatinine, microalbuminuria, alanine aminotransferase (ALT) and carotid IMT between the groups.
","[{'ForeName': 'Chin-Ying', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Sheng', 'Initials': 'WS', 'LastName': 'Huang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Dietetics, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Long-Teng', 'Initials': 'LT', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Heng-Shuen', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yow-Der', 'Initials': 'YD', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chu', 'Initials': 'WC', 'LastName': 'Chie', 'Affiliation': 'Department of Public Health, College of Public Health, Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chyi-Feng', 'Initials': 'CF', 'LastName': 'Jan', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Dean', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jaw-Shiun', 'Initials': 'JS', 'LastName': 'Tsai', 'Affiliation': 'Department of Family Medicine, National Taiwan University Hospital & National Taiwan University, Taipei, Taiwan.'}]",PloS one,['10.1371/journal.pone.0240158']
2779,33017484,Nivolumab-Induced Thrombotic Thrombocytopenic Purpura in a Patient with Anal Squamous Cell Carcinoma: A Lesson on Hematologic Toxicity from Immunotherapy.,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia and ischemic organ damage. It is mainly caused by an autoreactive antibody directed at ADAMTS13. Immunotherapy is frequently associated with autoimmune complications in cancer patients but only 3 cases of TTP have been reported, none implicating single treatment with the anti-PD-L1 antibody Nivolumab. We present the first identified and reported case of Nivolumab-associated TTP in a 51-year-old woman with Stage IIIc anal carcinoma who achieved complete response following chemoradiation and received adjuvant nivolumab as part of a randomized clinical trial. 12 weeks into treatment, she presented with dark urine, progressive fatigue and headache. TTP diagnosis was based on laboratory evidence of hemolytic anemia, thrombocytopenia, and ADAMTS13 activity of 9% associated with an inhibitor. She was treated with daily plasma exchange and oral prednisone and responded well to treatment, with platelet counts over 100 K/cmm within 4 days. We reviewed and summarized data from all reported cases of TTP associated with cancer immunotherapy. We provide guidance on identification and management of this devastating hematologic complication, focusing on the importance of early recognition, as most patients achieve complete recovery with appropriate treatment. KEY POINTS: TTP was originally excluded from previous reviews of hematologic Immune-Related Adverse Events (irAEs), however several cases have been reported in the past 2 years in patients treated with either single agent or combination of cytotoxic T lymphocyte associated antigen 4 and the programmed cell death receptor 1 (PD-1) or the PD-1 ligand inhibitors. Although rare, TTP is a life-threatening condition that could be challenging to diagnose and early recognition is key as delayed treatment is associated with significant increase in mortality. The pathophysiology of immunotherapy-induced TTP is likely related autoimmune inhibition of ADAMTS13; the addition of prednisone and Rituxmab to urgent plasmapheresis appears to be effective and should be part of the up-front management for these patients.",2020,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia and ischemic organ damage.","['cancer patients', '51-year-old woman with Stage IIIc anal carcinoma who achieved complete response following chemoradiation and received', 'Patient with Anal Squamous Cell Carcinoma']","['adjuvant nivolumab', 'daily plasma exchange and oral prednisone', 'Nivolumab-associated TTP', 'Nivolumab-Induced Thrombotic Thrombocytopenic Purpura', 'TTP', 'Immunotherapy']","['Thrombotic thrombocytopenic purpura (TTP', 'mortality', 'hemolytic anemia, thrombocytopenia, and ADAMTS13 activity', 'Hematologic Toxicity']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0279637', 'cui_str': 'Anal cancer'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0857305', 'cui_str': 'Thrombocytopenic purpura'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002878', 'cui_str': 'Hemolytic anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.038954,"Thrombotic thrombocytopenic purpura (TTP) is a rare but life-threatening microangiopathic hemolytic anemia characterized by thrombocytopenia, hemolytic anemia and ischemic organ damage.","[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Gergi', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Kara K', 'Initials': 'KK', 'LastName': 'Landry', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ades', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Barry', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Zakai', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Diego Adrianzen', 'Initials': 'DA', 'LastName': 'Herrera', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Larner College of Medicine at The University of Vermont, Burlington, VT, USA.'}]",The oncologist,['10.1002/onco.13553']
2780,33017510,FDA Approval Summary: Olaparib monotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.,"On December 19, 2018, the Food and Drug Administration (FDA) granted approval to olaparib monotherapy for first-line maintenance treatment of BRCA mutated (BRCAm) advanced ovarian cancer and on May 8, 2020, expanded the indication of olaparib to include its use in combination with bevacizumab for first-line maintenance treatment of homologous recombinant deficient (HRD)-positive advanced ovarian cancer. Both these approvals were based on randomized, double blind, placebo-controlled trials. Approval for olaparib monotherapy was based on the SOLO-1 trial, comparing the efficacy of olaparib versus placebo in patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer following surgical cytoreduction and first-line platinum-based chemotherapy. Two companion diagnostic (CDx) tests were approved with this indication: BRACAnalysis CDx, for germline BRCA1/2 alterations and FoundationOne CDx, for BRCA1/2 alterations in tissue specimens. Approval for olaparib in combination with bevacizumab was based on the results of the PAOLA-1 trial that compared olaparib with bevacizumab versus placebo plus bevacizumab in patients with advanced high-grade epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy and bevacizumab. Myriad myChoice CDx was designated as a companion diagnostic device for use of olaparib plus bevacizumab combination for ovarian cancer associated with HRD-positive status. Both trials demonstrated clinically meaningful improvements in progression-free survival (PFS) and favorable benefit-risk profiles for the indicated populations. This article summarizes the FDA thought process and data supporting the approval of olaparib as monotherapy and in combination with bevacizumab for maintenance therapy in this setting. IMPLICATIONS FOR PRACTICE: These approvals represent the first PARP inhibitor, alone or in combination with bevacizumab, approved in first-line maintenance treatment of women with advanced ovarian cancer following cytoreductive surgery and chemotherapy. In patients with BRCA-mutated (BRCAm) tumors, olaparib monotherapy demonstrated a 70% reduction in the risk of disease progression or death compared to placebo and olaparib in combination with bevacizumab demonstrated a 67% reduction in the risk of disease progression or death compared to bevacizumab alone in homologous recombination deficient (HRD)-positive tumors. These approvals represent a major advance for the treatment of women with advanced ovarian cancer who are in complete or partial response following their initial platinum-based chemotherapy.",2020,Both trials demonstrated clinically meaningful improvements in progression-free survival (PFS) and favorable benefit-risk profiles for the indicated populations.,"['women with advanced ovarian cancer following cytoreductive surgery and chemotherapy', 'homologous recombinant deficient (HRD)-positive advanced ovarian cancer', 'patients with advanced ovarian cancer', 'women with advanced ovarian cancer who are in complete or partial response following their initial platinum-based chemotherapy', 'patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer following surgical cytoreduction and first-line platinum-based chemotherapy', 'patients with advanced high-grade epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy and']","['placebo plus bevacizumab', 'Olaparib monotherapy', 'bevacizumab', 'placebo', 'olaparib versus placebo', 'olaparib plus bevacizumab combination', 'PARP inhibitor, alone or in combination with bevacizumab']","['progression-free survival (PFS) and favorable benefit-risk profiles', 'risk of disease progression or death']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.108563,Both trials demonstrated clinically meaningful improvements in progression-free survival (PFS) and favorable benefit-risk profiles for the indicated populations.,"[{'ForeName': 'Shaily', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Sanjeeve', 'Initials': 'S', 'LastName': 'Balasubramaniam', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Berman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Suzman', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Francisca Reyes', 'Initials': 'FR', 'LastName': 'Turcu', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Chatterjee', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Saritas-Yildirim', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Philip', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Center for Devices and Radiological Health, U.S. Food and Drug Administration.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration.'}]",The oncologist,['10.1002/onco.13551']
2781,32534142,Efficacy of delafloxacin versus moxifloxacin against atypical bacterial respiratory pathogens in adults with community-acquired bacterial pneumonia (CABP): Data from the Delafloxacin Phase 3 CABP Trial.,"OBJECTIVES


To report atypical pathogens from clinical trial data comparing delafloxacin to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia (CABP).
METHODS


Multiple diagnostic methods were employed to diagnose atypical infections including culture, serology, and urinary antigen.
RESULTS


The microbiological intent-to-treat (MITT) population included 520 patients; 30% had an atypical bacterial pathogen identified (156/520). Overall, 13.1% (68/520) had a monomicrobial atypical infection and 2.3% (12/520) had polymicrobial all-atypical infections. Among patients with polymicrobial infections, Streptococcus pneumoniae was the most frequently occurring co-infecting organism and Chlamydia pneumoniae was the most frequently occurring co-infecting atypical organism. For Mycoplasma pneumoniae and Legionella pneumophila, serology yielded the highest number of diagnoses. Delafloxacin and moxifloxacin had similar in vitro activity against M. pneumoniae and delafloxacin had greater activity against L. pneumophila. Two macrolide-resistant M. pneumoniae isolates were recovered. No fluoroquinolone-resistant M. pneumoniae were isolated. The rates of microbiological success (documented or presumed eradication) at test-of-cure were similar between the delafloxacin and moxifloxacin groups. There was no evidence of a correlation between minimum inhibitory concentration (MIC) and outcome; a high proportion of favorable outcomes was observed across all delafloxacin baseline MICs.
CONCLUSIONS


Delafloxacin may be considered a treatment option as monotherapy for CABP in adults, where broad-spectrum coverage including atypical activity is desirable.",2020,"There was no evidence of a correlation between minimum inhibitory concentration (MIC) and outcome; a high proportion of favorable outcomes was observed across all delafloxacin baseline MICs.
","['adults with community-acquired bacterial pneumonia (CABP', '520 patients; 30% had an atypical bacterial pathogen identified (156/520']","['moxifloxacin', 'Delafloxacin and moxifloxacin', 'delafloxacin', 'Delafloxacin']","['monomicrobial atypical infection', 'vitro activity against M. pneumoniae and delafloxacin had greater activity against L. pneumophila', 'minimum inhibitory concentration (MIC', 'rates of microbiological success']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C2828290', 'cui_str': 'delafloxacin'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0023238', 'cui_str': 'Legionella pneumophila'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}]",520.0,0.0269576,"There was no evidence of a correlation between minimum inhibitory concentration (MIC) and outcome; a high proportion of favorable outcomes was observed across all delafloxacin baseline MICs.
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'McCurdy', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: smccurdy@melinta.com.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nenninger', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: ashley.nenninger@hologic.com.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sheets', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: amanda.j.sheets@gmail.com.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Keedy', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: kara.keedy@aimmaxrx.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawrence', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: llawr0808@outlook.com.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Quintas', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: mquintas@artugentherapeutics.com.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cammarata', 'Affiliation': 'Melinta Therapeutics, Morristown, NJ, USA. Electronic address: scammarata@melinta.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.018']
2782,30541074,Prognostic value of left atrial strain in predicting cardiovascular morbidity and mortality in the general population.,"AIMS


Left atrial (LA) enlargement predicts cardiovascular risk. The prognostic value of left atrial peak reservoir strain (LA RS) by two-dimensional speckle tracking in the general population is currently unknown. This study sought to determine the prognostic value of LA RS in the general population.
METHODS AND RESULTS


A total of 385 participants without atrial fibrillation, heart failure (HF), and ischaemic heart disease (IHD) had an echocardiogram including left ventricular and LA speckle-tracking analysis performed. LA RS was averaged from the three apical views. The endpoint was a composite of incident IHD, HF, or cardiovascular death. Median follow-up was 12.6 years (interquartile-range 11.5-12.8 years). Follow-up was 100%. Fifty-one participants (13.3%) reached the composite outcome. LA RS was a univariable predictor of outcome [hazard ratio (HR) 1.25, 95% confidence interval (95% CI) 1.09-1.43; P = 0.002]. However, LA RS did not remain an independent predictor of outcome after adjustment for clinical parameters. The prognostic value was modified by sex (P = 0.011). LA RS predicted the composite outcome in women but not in men when adjusting for clinical parameters (women: HR 1.46, 95% CI 1.05-2.02; P = 0.025) (men: HR 0.96, 95% CI 0.81-1.14; P = 0.65). Further adjustment for echocardiographic parameters did not significantly alter the results. LA RS added incremental prognostic information in addition to SCORE and the American Heart Association/American College of Cardiology Pooled Cohort Equation in women only.
CONCLUSION


LA RS is a univariable predictor of cardiovascular morbidity and mortality in the general population. However, the prognostic value of LA RS is modified by sex. LA RS is an independent predictor of outcome in women but not in men.",2019,"LA RS was a univariable predictor of outcome [hazard ratio (HR) 1.25, 95% confidence interval (95% CI) 1.09-1.43; P = 0.002].","['385 participants without atrial fibrillation, heart failure (HF), and ischaemic heart disease (IHD) had an echocardiogram including left ventricular and LA speckle-tracking analysis performed']","['LA RS', 'left atrial peak reservoir strain (LA RS']","['cardiovascular morbidity and mortality', 'LA RS', 'composite of incident IHD, HF, or cardiovascular death']","[{'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",385.0,0.107652,"LA RS was a univariable predictor of outcome [hazard ratio (HR) 1.25, 95% confidence interval (95% CI) 1.09-1.43; P = 0.002].","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Modin', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Sofie Reumert', 'Initials': 'SR', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Møgelvang', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Alia Saed', 'Initials': 'AS', 'LastName': 'Alhakak', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Jan Skov', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev & Gentofte Hospital, University of Copenhagen, Denmark.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jey181']
2783,30654388,Dual Infection with Hepatitis B Virus and Hepatitis C Virus Correlated with Type 2 Diabetes Mellitus.,"BACKGROUND


Conflicting data exist regarding the relationship between dual infection of hepatitis B virus (HBV) and hepatitis C virus (HCV) with type 2 diabetes mellitus (T2DM). We assessed dual infection of HBV and HCV with the levels of blood glucose and development of DM.
METHODS


A total of 9621 participants in a community-based study were enrolled from 18 towns in Maoli county of Taiwan. Blood samples were collected and tested for hepatitis B surface antigen (HBsAg) and antibodies (HBsAb), antibodies against hepatitis C virus (anti-HCV) and fasting plasma glucose. DM was defined as fasting plasma glucose≥126 mg per 100 ml.
RESULTS


Only 0.7% of total participants had HBV/HCV coinfection. The prevalence of HBV and HCV monoinfection were 9.9  and 5.7%, respectively. Adjusted blood glucose levels and development risk of T2DM (odds ratio [OR], 2.55; p<0.001) were significantly high among HBV/HCV coinfection group using multivariate linear regression adjusted for age, gender, education, race and BMI. Furthermore, using multivariate logistic regression models adjusted for covariates, HCV mono-and HBV/ HCV coinfection significantly increased on blood glucose levels.
CONCLUSIONS


Our study shows HBV/HCV coinfection was significantly correlated with blood glucose levels. A significant proportion (28%) of participants with HBV/HCV coinfection developed T2DM. Although the precise mechanisms of dual positive infection of HBV and HCV are unclear, there is increasing evidence that dual infection of HCV and HBV is strongly associated with the development of T2DM.",2020,"Furthermore, using multivariate logistic regression models adjusted for covariates, HCV mono-and HBV/ HCV coinfection significantly increased on blood glucose levels.
","['Type 2 Diabetes Mellitus', '9621 participants in a community-based study were enrolled from 18 towns in Maoli county of Taiwan']",[],"['HBV/HCV coinfection', 'blood glucose levels', 'prevalence of HBV and HCV monoinfection', 'Adjusted blood glucose levels and development risk of T2DM (odds ratio ', 'dual infection of HBV and HCV with the levels of blood glucose and development of DM', 'hepatitis B surface antigen (HBsAg) and antibodies (HBsAb), antibodies against hepatitis C virus (anti-HCV) and fasting plasma glucose', 'DM']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]",[],"[{'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",9621.0,0.0189409,"Furthermore, using multivariate logistic regression models adjusted for covariates, HCV mono-and HBV/ HCV coinfection significantly increased on blood glucose levels.
","[{'ForeName': 'Ping-Yi', 'Initials': 'PY', 'LastName': 'Lin', 'Affiliation': 'Transplant Medicine & Surgery Research Centre, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Shu-Chu', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Public Health Bureau of Miaoli County Government, Miaoli City, Miaoli County, Taiwan.'}, {'ForeName': 'Tsai-Chang', 'Initials': 'TC', 'LastName': 'Lo', 'Affiliation': 'Public Health Bureau of Miaoli County Government, Miaoli City, Miaoli County, Taiwan.'}, {'ForeName': 'Hsien-Wen', 'Initials': 'HW', 'LastName': 'Kuo', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, National Yang-Ming University, Taipei, Taiwan.'}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/a-0794-6135']
2784,30872600,Revealing Tumor Habitats from Texture Heterogeneity Analysis for Classification of Lung Cancer Malignancy and Aggressiveness.,"We propose an approach for characterizing structural heterogeneity of lung cancer nodules using Computed Tomography Texture Analysis (CTTA). Measures of heterogeneity were used to test the hypothesis that heterogeneity can be used as predictor of nodule malignancy and patient survival. To do this, we use the National Lung Screening Trial (NLST) dataset to determine if heterogeneity can represent differences between nodules in lung cancer and nodules in non-lung cancer patients. 253 participants are in the training set and 207 participants in the test set. To discriminate cancerous from non-cancerous nodules at the time of diagnosis, a combination of heterogeneity and radiomic features were evaluated to produce the best area under receiver operating characteristic curve (AUROC) of 0.85 and accuracy 81.64%. Second, we tested the hypothesis that heterogeneity can predict patient survival. We analyzed 40 patients diagnosed with lung adenocarcinoma (20 short-term and 20 long-term survival patients) using a leave-one-out cross validation approach for performance evaluation. A combination of heterogeneity features and radiomic features produce an AUROC of 0.9 and an accuracy of 85% to discriminate long- and short-term survivors.",2019,A combination of heterogeneity features and radiomic features produce an AUROC of 0.9 and an accuracy of 85% to discriminate long- and short-term survivors.,"['253 participants are in the training set and 207 participants in the test set', 'non-lung cancer patients', '40 patients diagnosed with lung adenocarcinoma (20 short-term and 20 long-term survival patients) using a leave-one-out cross validation approach for performance evaluation']",['Computed Tomography Texture Analysis (CTTA'],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],40.0,0.0501546,A combination of heterogeneity features and radiomic features produce an AUROC of 0.9 and an accuracy of 85% to discriminate long- and short-term survivors.,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Cherezov', 'Affiliation': 'Department of Computer Sciences and Engineering, University of South Florida, Tampa, Florida, USA. cherezov@mail.usf.edu.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Goldgof', 'Affiliation': 'Department of Computer Sciences and Engineering, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Department of Computer Sciences and Engineering, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gillies', 'Affiliation': 'Department of Cancer Physiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schabath', 'Affiliation': 'Department of Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Institute of Information Systems, University of Applied Sciences Western Switzerland (HES-SO), Sierre, Switzerland.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Depeursinge', 'Affiliation': 'Institute of Information Systems, University of Applied Sciences Western Switzerland (HES-SO), Sierre, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-38831-0']
2785,30940872,Halve the dose while maintaining image quality in paediatric Cone Beam CT.,"Cone beam CT (CBCT) for dentomaxillofacial paediatric assessment has been widely used despite the uncertainties of the risks of the low-dose radiation exposures. The aim of this work was to investigate the clinical performance of different CBCT acquisition protocols towards the optimization of paediatric exposures. Custom-made anthropomorphic phantoms were scanned using a CBCT unit in six protocols. CT slices were blinded, randomized and presented to three observers, who scored the image quality using a 4-point scale along with their level of confidence. Sharpness level was also measured using a test object containing an air/PMMA e,dge. The effective dose was calculated by means of a customized Monte Carlo (MC) framework using previously validated paediatric voxels models. The results have shown that the protocols set with smaller voxel size (180 µm), even when decreasing exposure parameters (kVp and mAs), showed high image quality scores and increased sharpness. The MC analysis showed a gradual decrease in effective dose when exposures parameters were reduced, with an emphasis on an average reduction of 45% for the protocol that combined 70 kVp, 16 mAs and 180 µm voxel size. In contrast, both ""ultra-low dose"" protocols that combined a larger voxel size (400 µm) with lower mAs (7.4 mAs) demonstrated the lowest scores with high levels of confidence unsuitable for an anatomical approach. In conclusion, a significant decrease in the effective dose can be achieved while maintaining the image quality required for paediatric CBCT.",2019,"In conclusion, a significant decrease in the effective dose can be achieved while maintaining the image quality required for paediatric CBCT.",[],"['CBCT acquisition protocols', 'Cone beam CT']",['Sharpness level'],[],"[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0322241,"In conclusion, a significant decrease in the effective dose can be achieved while maintaining the image quality required for paediatric CBCT.","[{'ForeName': 'Anne Caroline', 'Initials': 'AC', 'LastName': 'Oenning', 'Affiliation': 'Paris Descartes University - Sorbonne Paris Cité, EA 2496 - Orofacial Pathologies, Imaging and Biotherapies Lab, Montrouge, France and Dental Medicine Department - Bretonneau Hospital, HUPNVS, AP-HP, Paris, France.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Pauwels', 'Affiliation': 'Department of Mechanical Engineering, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stratis', 'Affiliation': 'OMFS IMPATH research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'De Faria Vasconcelos', 'Affiliation': 'OMFS IMPATH research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Tijskens', 'Affiliation': 'OMFS IMPATH research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Annelore', 'Initials': 'A', 'LastName': 'De Grauwe', 'Affiliation': 'OMFS IMPATH research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Reinhilde', 'Initials': 'R', 'LastName': 'Jacobs', 'Affiliation': 'OMFS IMPATH research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Oral & Maxillofacial Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Salmon', 'Affiliation': 'Paris Descartes University - Sorbonne Paris Cité, EA 2496 - Orofacial Pathologies, Imaging and Biotherapies Lab, Montrouge, France and Dental Medicine Department - Bretonneau Hospital, HUPNVS, AP-HP, Paris, France.'}]",Scientific reports,['10.1038/s41598-019-41949-w']
2786,33021328,[Should all patients with traumatic brain injury receive tranexamic acid?],"Traumatic brain injury (TBI) is a leading cause of death and disability. Progressive intracranial bleeding is common in TBI and worsens outcome. The multicentre, randomized placebo-controlled CRASH-3 study enrolling 12,737 patients showed that early, <3h, administration of tranexamic acid (TXA) decreased mortality in mild-moderate TBI patients. In accordance with large previous trials, thromboembolic complications were not increased. In view of the favourable safety profile of TXA and the devastating effects from intracranial bleeds, the authors argue that TXA be administered within 3h post-injury to moderate-severe TBI patients, and in mild TBI to those with intracranial haemorrhage on acute CT.",2020,"In accordance with large previous trials, thromboembolic complications were not increased.","['mild-moderate TBI patients', 'patients with traumatic brain injury receive', 'Traumatic brain injury (TBI']","['TXA', 'tranexamic acid (TXA', 'placebo', 'tranexamic acid']",['thromboembolic complications'],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",12737.0,0.267762,"In accordance with large previous trials, thromboembolic complications were not increased.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rostami', 'Affiliation': 'docent, specialistläkare, institutionen för neurovetenskap/neurokirurgi, Uppsala universitet; medlem i European Association of Neurosurgical Societies (EANS) sektion för trauma- och intensivvård; ordförande för Yngre neurokir-urger.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Kongstad', 'Affiliation': '.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Marklund', 'Affiliation': 'professor, överläkare, Lunds universitet; Skånes universitetssjukhus, Lund; ordförande för EANS sektion för trauma- och intensivvård.'}]",Lakartidningen,[]
2787,33021348,"Primary prevention of fat and weight gain among obesity susceptible healthy weight preschool children. Main results from the ""Healthy Start"" randomized controlled intervention.","BACKGROUND


A vital public health challenge lies in understanding the primary drivers behind excessive weight gain among healthy weight individuals.
OBJECTIVES


To examine if excessive weight and fat gain can be prevented among healthy weight, obesity susceptible children aged 2 to 6 years.
METHODS


Eligible children were identified based on information on either a high birth weight, maternal pre-pregnancy obesity or maternal low educational level from national registries, and randomized into an intervention group, a control group and a shadow control group. All children with overweight at baseline were excluded from subsequent analysis (n = 196), while healthy weight children were included (n = 926). The intervention was designed to deliver improvements in diet and physical activity habits, optimization of sleep quantity and quality, and reduction of family stress. The average intervention period was 1.3 years.
RESULTS


Intention-to-treat analyses indicated a lower gain in percentage fat mass and a higher gain in fat-free mass in the intervention group compared with the control group. However, the results should be interpreted with caution, as they were clinically small and borderline significant, only.
CONCLUSION


This primary prevention intervention among young healthy weight children with susceptibility to future obesity had clinically small effects on growth and body composition. More interventions, conducting primary obesity prevention, are urgently needed.",2020,This primary prevention intervention among young healthy weight children with susceptibility to future obesity had clinically small effects on growth and body composition.,"['obesity susceptible healthy weight preschool children', 'young healthy weight children', 'healthy weight, obesity susceptible children aged 2 to 6\u2009years', 'All children with overweight at baseline were excluded from subsequent analysis (n = 196), while healthy weight children were included (n = 926', 'Eligible children were identified based on information on either a high birth weight, maternal pre-pregnancy obesity or maternal low educational level from national registries', 'healthy weight individuals']",['control group and a shadow control group'],"['fat and weight gain', 'diet and physical activity habits, optimization of sleep quantity and quality, and reduction of family stress', 'percentage fat mass']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085195', 'cui_str': 'Shadowing (Histology)'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0577730', 'cui_str': 'Family tension'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",926.0,0.0325841,This primary prevention intervention among young healthy weight children with susceptibility to future obesity had clinically small effects on growth and body composition.,"[{'ForeName': 'Nanna Julie', 'Initials': 'NJ', 'LastName': 'Olsen', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region, Frederiksberg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ängquist', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Frederiksen', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region, Frederiksberg, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lykke Mortensen', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Lilienthal Heitmann', 'Affiliation': 'Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, the Capital Region, Frederiksberg, Denmark.'}]",Pediatric obesity,['10.1111/ijpo.12736']
2788,33021402,After-Action Reviews and Long-Term Performance: An Experimental Examination in the Context of an Emergency Simulation.,"OBJECTIVE


The present study examined the effectiveness of after-action reviews (AARs; also known as debriefing) in mitigating skill decay.
BACKGROUND


Research on the long-term effectiveness of AARs is meager. To address this gap in the literature, we conducted an experimental study that also overcomes some research design issues that characterize the limited extant research.
METHOD


Eighty-four participants were randomly assigned to an AAR or non-AAR condition and trained to operate a PC-based fire emergency simulator. During the initial acquisition phase, individuals in the AAR condition were allowed to review their performance after each practice session, whereas individuals in the non-AAR condition completed a filler task. About 12 weeks later, participants returned to the lab to complete four additional practice sessions using a similar scenario (i.e., the retention and reacquisition phase).
RESULTS


The performance of participants in the AAR condition degraded more after nonuse but also recovered faster than the performance of participants in the non-AAR condition, although these effects were fairly small and not statistically significant.
CONCLUSION


Consistent with the limited research on the long-term effectiveness of AARs, our findings failed to support their effectiveness as a decay-prevention intervention. Because the present study was conducted in a laboratory setting using a relatively small sample of undergraduate students, additional research is warranted.
APPLICATION


Based on the results of the present study, we suggest some additional strategies that trainers might consider to support long-term skill retention when using AARs.",2020,"The performance of participants in the AAR condition degraded more after nonuse but also recovered faster than the performance of participants in the non-AAR condition, although these effects were fairly small and not statistically significant.
",['Eighty-four participants'],['AAR or non-AAR condition and trained to operate a PC-based fire emergency simulator'],[],"[{'cui': 'C4319623', 'cui_str': '84'}]","[{'cui': 'C0574156', 'cui_str': 'Afar language'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]",[],84.0,0.0634205,"The performance of participants in the AAR condition degraded more after nonuse but also recovered faster than the performance of participants in the non-AAR condition, although these effects were fairly small and not statistically significant.
","[{'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Muñoz', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Cortéz', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Constanza B', 'Initials': 'CB', 'LastName': 'Álvarez', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Raggio', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Concha', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Francisca I', 'Initials': 'FI', 'LastName': 'Rojas', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Winfred', 'Initials': 'W', 'LastName': 'Arthur', 'Affiliation': '14736 Texas A&M University, College Station, USA.'}, {'ForeName': 'Bastián M', 'Initials': 'BM', 'LastName': 'Fischer', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Rodriguez', 'Affiliation': '28034 Universidad Adolfo Ibáñez, Santiago, Chile.'}]",Human factors,['10.1177/0018720820958848']
2789,33021404,The Clinical Application of the Deep Learning Technique for Predicting Trigger Origins in Paroxysmal Atrial Fibrillation Patients with Catheter Ablation.,"Background  - Non-pulmonary vein (NPV) trigger has been reported as an important predictor of recurrence post-atrial fibrillation (AF) ablation. Elimination of NPV triggers can reduce the recurrence of post-ablation AF. Deep learning was applied to pre-ablation pulmonary vein computed tomography (PVCT) geometric slices to create a prediction model for NPV triggers in patients with paroxysmal atrial fibrillation (PAF).  Methods  - We retrospectively analyzed 521 PAF patients who underwent catheter ablation of PAF. Among them, PVCT geometric slices from 358 non-recurrent AF patients (1-3 mm interspace per slice, 20-200 slices for each patient, ranging from the upper border of the left atrium to the bottom of the heart, for a total of 23683 images of slices) were used in the deep learning process, the ResNet34 of the neural network, to create the prediction model of the NPV trigger. There were 298 (83.2%) patients with only pulmonary vein (PV) triggers and 60 (16.8%) patients with NPV triggers +/- PV triggers. The patients were randomly assigned to either training, validation or test groups and their data was allocated according to those sets. The image datasets were split into training (n=17340), validation (n=3491), and testing (n=2852) groups, which had completely independent sets of patients.  Results  - The accuracy of prediction in each PVCT image for NPV trigger was up to 82.4±2.0%. The sensitivity and specificity were 64.3±5.4% and 88.4±1.9%, respectively. For each patient, the accuracy of prediction for a NPV trigger was 88.6±2.3%. The sensitivity and specificity were 75.0±5.8% and 95.7±1.8%, respectively. The area under the curve (AUC) for each image and patient were 0.82±0.01 and 0.88±0.07, respectively.  Conclusions  - The deep learning model using pre-ablation PVCT can be applied to predict the trigger origins in PAF patients receiving catheter ablation. The application of this model may identify patients with a high risk of NPV trigger before ablation.",2020,The accuracy of prediction in each PVCT image for NPV trigger was up to 82.4±2.0%.,"['patients with paroxysmal atrial fibrillation (PAF', '521 PAF patients who underwent', 'patients with a high risk of NPV trigger before ablation', 'There were 298 (83.2%) patients with only pulmonary vein (PV) triggers and 60 (16.8%) patients with NPV triggers ', 'Paroxysmal Atrial Fibrillation Patients with Catheter Ablation', 'PAF patients receiving catheter ablation']","['Deep learning was applied to pre-ablation pulmonary vein computed tomography (PVCT) geometric slices', 'catheter ablation of PAF', 'Deep Learning Technique']","['sensitivity and specificity', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",23683.0,0.0165084,The accuracy of prediction in each PVCT image for NPV trigger was up to 82.4±2.0%.,"[{'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Lin', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hung-Hsun', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Center of Teaching and Learning Development, National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Wei-Shiang', 'Initials': 'WS', 'LastName': 'Chen', 'Affiliation': 'Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Yenn-Jiang', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Lo', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Hu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Fa-Po', 'Initials': 'FP', 'LastName': 'Chung', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tze-Fan', 'Initials': 'TF', 'LastName': 'Chao', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ta-Chuan', 'Initials': 'TC', 'LastName': 'Tuan', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jo-Nan', 'Initials': 'JN', 'LastName': 'Liao', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chin-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ting-Yung', 'Initials': 'TY', 'LastName': 'Chang', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-I', 'Initials': 'CI', 'LastName': 'Wu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Kuo', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Mei-Han', 'Initials': 'MH', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, School of Medicine, National Yang-Ming University & Department of Radiology, Taipei Veterans General Hospital & Department of Medical Imaging, Diagnostic Radiology, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chun-Ku', 'Initials': 'CK', 'LastName': 'Chen', 'Affiliation': 'Institute of Clinical Medicine & Faculty of Medicine, School of Medicine, National Yang-Ming University & Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ying-Yueh', 'Initials': 'YY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yang-Che', 'Initials': 'YC', 'LastName': 'Shiu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Henry Horng-Shing', 'Initials': 'HH', 'LastName': 'Lu', 'Affiliation': 'Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Shih-Ann', 'Initials': 'SA', 'LastName': 'Chen', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital & Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008518']
2790,33021440,MRI-guided transurethral ultrasound ablation of prostate cancer.,"BACKGROUND


MRI-guided transurethral ultrasound ablation (TULSA) uses directional thermal ultrasound under MRI thermometry feedback control for prostatic ablation. We report 12-month outcomes from a prospective multicenter trial (TACT).
METHODS


115 men with favorable to intermediate risk prostate cancer across 13 centers were treated with. whole-gland ablation sparing the urethra and apical sphincter. The co-primary 12-month endpoints were safety and efficacy.
RESULTS


72 (63%) had GG2 and 77 (67%) had NCCN intermediate-risk disease. Median treatment delivery time was 51 minutes with 98% (IQR 95-99%) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on MRI thermometry. Grade 3 adverse events occurred in 9 (8%) men. The primary endpoint (FDA mandated) of PSA reduction ≥75% was achieved in 110 of 115 (96%) with median PSA reduction of 95% and nadir of 0.34 ng/ml. Median prostate volume decreased from 37 to 3 cc. Among 68 men with pre-treatment GG2, 52 (79%) were free of GG2 disease on 12-month biopsy. Of 111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer. Erections (IIEF Q2 ≥ 2) were maintained/regained in 69 of 92 (75%). Multivariate predictors of persistent GG2 at 12 months included intra-prostatic calcifications at screening, suboptimal MRI thermal coverage of target volume, and a PIRADS ≥ 3 lesion at 12-month MRI (p < 0.05).
CONCLUSIONS


The TACT study of MRI-guided transurethral ultrasound whole-gland ablation in men with localized prostate cancer demonstrated effective tissue ablation and PSA reduction with low rates of toxicity and residual disease.",2020,Median treatment delivery time was 51 minutes with 98% (IQR 95-99%) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on MRI thermometry.,"['prostate cancer', '68 men with pre-treatment GG2, 52 (79%) were free of GG2 disease on 12-month biopsy', 'men with localized prostate cancer', '115 men with favorable to intermediate risk prostate cancer across 13 centers were treated with', '111 men with 12-month biopsy data, 72 (65%) had no evidence of cancer']","['MRI-guided transurethral ultrasound ablation (TULSA', 'MRI-guided transurethral ultrasound ablation', 'MRI-guided transurethral ultrasound whole-gland ablation']","['Grade 3 adverse events', 'thermal coverage of target volume and spatial ablation precision', 'Median treatment delivery time', 'primary endpoint (FDA mandated) of PSA reduction', 'median PSA reduction', 'safety and efficacy', 'Median prostate volume', 'Erections (IIEF Q2 ≥ 2', 'NCCN intermediate-risk disease']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",115.0,0.0284644,Median treatment delivery time was 51 minutes with 98% (IQR 95-99%) thermal coverage of target volume and spatial ablation precision of ±1.4 mm on MRI thermometry.,"[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Klotz', 'Affiliation': ''}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Pavlovich', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Gencay', 'Initials': 'G', 'LastName': 'Hatiboglu', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Penson', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Raman', 'Affiliation': ''}, {'ForeName': 'Aytekin', 'Initials': 'A', 'LastName': 'Oto', 'Affiliation': ''}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Fütterer', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serrallach', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Relle', 'Affiliation': ''}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Lotan', 'Affiliation': ''}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bonekamp', 'Affiliation': ''}, {'ForeName': 'Masoom', 'Initials': 'M', 'LastName': 'Haider', 'Affiliation': ''}, {'ForeName': 'Temel', 'Initials': 'T', 'LastName': 'Tirkes', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': ''}, {'ForeName': 'Katarzyna J', 'Initials': 'KJ', 'LastName': 'Macura', 'Affiliation': ''}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Persigehl', 'Affiliation': ''}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Bomers', 'Affiliation': ''}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Burtnyk', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Staruch', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Eggener', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001362']
2791,32960773,Applying Digital Information Delivery to Convert Habits of Antibiotic Use in Primary Care in Germany: Mixed-Methods Study.,"BACKGROUND


Antimicrobial resistance is an important global health issue. In Germany, the national agenda supports various interventions to convert habits of antibiotic use. In the CHANGE-3 (Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care) study, digital tools were applied for information delivery: tablet computers in primary care practices, e-learning platforms for medical professionals, and a public website to promote awareness and health literacy among primary care physicians, their teams, and their patients.
OBJECTIVE


This study is embedded in the process evaluation of the CHANGE-3 study. The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
METHODS


This study used a convergent-parallel mixed-methods design. Audio-recorded semistructured telephone interviews were conducted with physicians, nonphysician health professionals, and patients in the CHANGE-3 program. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was performed based on the inductive category of information provision via digital information tools. Identified themes were related to the main postulates of Diffusion of Innovations theory (DIT) to provide an explanatory frame. In addition, data generated through a structured survey with physicians and nonphysician health professionals in the program were analyzed descriptively and integrated with the qualitative data to explore the complementarity of the findings.
RESULTS


Findings regarding the acceptance and uptake of digital devices were related to three postulates of DIT: innovation characteristics, communication channels, and unanticipated consequences. Participants considered the provided digital educative solutions to be supportive for promoting health literacy regarding conversion of habits of antibiotic use. However, health care professionals found it challenging to integrate these solutions into existing routines in primary care and to align them with their professional values. Low technology affinity was a major barrier to the use of digital information in primary care. Patients welcomed the general idea of introducing health-related information in digital formats; however, they expressed concerns about device-related hygiene and the appropriateness of the digital tools for older patients.
CONCLUSIONS


Patients and medical professionals in German primary care are reluctant to use digital devices for information and education. Using a Diffusion of Innovations approach can support assessment of existing barriers and provide information about setting-specific preconditions that are necessary for future tailoring of implementation strategies.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 15061174; http://www.isrctn.com/ISRCTN15061174.",2020,"The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
","['primary care in Germany', 'Primary Care in Germany', 'older patients']",[],['acceptance and uptake of digital devices'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0477936,"The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany.
","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Poss-Doering', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kuehn', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kamradt', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Glassen', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}]",Journal of medical Internet research,['10.2196/18200']
2792,31721042,Dwelling on simple stimuli in visual search.,"Research and theories on visual search often focus on visual guidance to explain differences in search. Guidance is the tuning of attention to target features and facilitates search because distractors that do not show target features can be more effectively ignored (skipping). As a general rule, the better the guidance is, the more efficient search is. Correspondingly, behavioral experiments often interpreted differences in efficiency as reflecting varying degrees of attentional guidance. But other factors such as the time spent on processing a distractor (dwelling) or multiple visits to the same stimulus in a search display (revisiting) are also involved in determining search efficiency. While there is some research showing that dwelling and revisiting modulate search times in addition to skipping, the corresponding studies used complex naturalistic and category-defined stimuli. The present study tests whether results from prior research can be generalized to more simple stimuli, where target-distractor similarity, a strong factor influencing search performance, can be manipulated in a detailed fashion. Thus, in the present study, simple stimuli with varying degrees of target-distractor similarity were used to deliver conclusive evidence for the contribution of dwelling and revisiting to search performance. The results have theoretical and methodological implications: They imply that visual search models should not treat dwelling and revisiting as constants across varying levels of search efficiency and that behavioral search experiments are equivocal with respect to the responsible processing mechanisms underlying more versus less efficient search. We also suggest that eye-tracking methods may be used to disentangle different search components such as skipping, dwelling, and revisiting.",2020,"As a general rule, the better the guidance is, the more efficient search is.",[],[],[],[],[],[],,0.0250319,"As a general rule, the better the guidance is, the more efficient search is.","[{'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Horstmann', 'Affiliation': 'Department of Psychology, Bielefeld University, PO Box 100 131, 33 501, Bielefeld, Germany. gernot.horstmann@uni-bielefeld.de.'}, {'ForeName': 'Stefanie I', 'Initials': 'SI', 'LastName': 'Becker', 'Affiliation': 'University of Queensland, St Lucia, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grubert', 'Affiliation': 'Durham University, Durham, UK.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01872-8']
2793,31741317,Flexible weighting of target features based on distractor context.,"Models of attention posit that attentional priority is established by summing the saliency and relevancy signals from feature-selective maps. The dimension-weighting account further hypothesizes that information from each feature-selective map is weighted based on expectations of how informative each dimension will be. In the current studies, we investigated the question of whether attentional biases to the features of a conjunction target (color and orientation) differ when one dimension is expected to be more diagnostic of the target. In a series of color-orientation conjunction search tasks, observers saw an exact cue for the upcoming target, while the probability of distractors sharing a target feature in each dimension was manipulated. In one context, distractors were more likely to share the target color, and in another, distractors were more likely to share the target orientation. The results indicated that despite an overall bias toward color, attentional priority to each target feature was flexibly adjusted according to distractor context: RT and accuracy performance was better when the diagnostic feature was expected than unexpected. This occurred both when the distractor context was learned implicitly and explicitly. These results suggest that feature-based enhancement can occur selectively for the dimension expected to be most informative in distinguishing the target from distractors.",2020,These results suggest that feature-based enhancement can occur selectively for the dimension expected to be most informative in distinguishing the target from distractors.,[],[],"['overall bias toward color, attentional priority to each target feature was flexibly adjusted according to distractor context: RT and accuracy performance']",[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0200798,These results suggest that feature-based enhancement can occur selectively for the dimension expected to be most informative in distinguishing the target from distractors.,"[{'ForeName': 'Jeongmi', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Culture Technology, Korea Advanced Institute of Science and Technology, 291 Daehak-ro, Yuseong-gu, Daejeon, 34141, South Korea. jeongmi@kaist.ac.kr.'}, {'ForeName': 'Joy J', 'Initials': 'JJ', 'LastName': 'Geng', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, 267 Cousteau Pl, Davis, CA, 95618, USA.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01910-5']
2794,31792893,Extra-foveal Processing of Object Semantics Guides Early Overt Attention During Visual Search.,"Eye-tracking studies using arrays of objects have demonstrated that some high-level processing of object semantics can occur in extra-foveal vision, but its role on the allocation of early overt attention is still unclear. This eye-tracking visual search study contributes novel findings by examining the role of object-to-object semantic relatedness and visual saliency on search responses and eye-movement behaviour across arrays of increasing size (3, 5, 7). Our data show that a critical object was looked at earlier and for longer when it was semantically unrelated than related to the other objects in the display, both when it was the search target (target-present trials) and when it was a target's semantically related competitor (target-absent trials). Semantic relatedness effects manifested already during the very first fixation after array onset, were consistently found for increasing set sizes, and were independent of low-level visual saliency, which did not play any role. We conclude that object semantics can be extracted early in extra-foveal vision and capture overt attention from the very first fixation. These findings pose a challenge to models of visual attention which assume that overt attention is guided by the visual appearance of stimuli, rather than by their semantics.",2020,"Our data show that a critical object was looked at earlier and for longer when it was semantically unrelated than related to the other objects in the display, both when it was the search target (target-present trials) and when it was a target's semantically related competitor (target-absent trials).",[],[],[],[],[],[],,0.0432146,"Our data show that a critical object was looked at earlier and for longer when it was semantically unrelated than related to the other objects in the display, both when it was the search target (target-present trials) and when it was a target's semantically related competitor (target-absent trials).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cimminella', 'Affiliation': 'Human Cognitive Neuroscience, Psychology, University of Edinburgh, Edinburgh, UK. francesco.cimminella@gmail.com.'}, {'ForeName': 'Sergio Della', 'Initials': 'SD', 'LastName': 'Sala', 'Affiliation': 'Human Cognitive Neuroscience, Psychology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Moreno I', 'Initials': 'MI', 'LastName': 'Coco', 'Affiliation': 'Human Cognitive Neuroscience, Psychology, University of Edinburgh, Edinburgh, UK. moreno.cocoi@gmail.com.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01906-1']
2795,31875315,Coordinating the interaction between past and present: Visual working memory for feature bindings overwritten by subsequent action to matching features.,"The object-file framework forwarded by Kaheman, Treisman, and Gibbs (1992) has been enormously influential in our understanding of how the visual system links together prior visual content with a current input. Although this framework was initially developed to account for the perceptual benefits associated with feature conjunction repetitions, the present series of experiments examines how the core processes of this framework may also help explain behavior in tasks that require explicit remembering of visual information over the short term. Building off our previous work (Fiacconi & Milliken, 2012, 2013), here we introduce a procedure that affords the opportunity to examine the contributions of object-file review processes to both speeded performance and visual short-term memory (VWM) within the same task. Across two experiments we demonstrate a novel coupling between memory accuracy and speeded performance, such that the conditions that promote faster performance also tend to produce better memory, and vice versa. These findings are discussed in relation to the object-file framework and suggest that the object-file review processes known to guide behavior in speeded performance tasks may also have important mnemonic consequences. Together, these findings unite two lines of research to which Anne Treisman made indelible contributions.",2020,"Across two experiments we demonstrate a novel coupling between memory accuracy and speeded performance, such that the conditions that promote faster performance also tend to produce better memory, and vice versa.",[],[],[],[],[],[],,0.020514,"Across two experiments we demonstrate a novel coupling between memory accuracy and speeded performance, such that the conditions that promote faster performance also tend to produce better memory, and vice versa.","[{'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Fiacconi', 'Affiliation': 'Department of Psychology, University of Guelph, Guelph, Ontario, Canada. cfiaccon@uoguelph.ca.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Cali', 'Affiliation': 'Department of Psychology, Neuroscience, & Behavior, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Facultad de Psicología, Universidad de Granada, Granada, Spain.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Milliken', 'Affiliation': 'Department of Psychology, Neuroscience, & Behavior, McMaster University, Hamilton, Ontario, Canada.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01880-8']
2796,31883218,"Associations between dietary patterns, eating behaviours, and body composition and adiposity in 3-year-old children of mothers with obesity.","BACKGROUND


The relationships between eating habits, behaviours, and the development of obesity in preschool children is not well established.
OBJECTIVE


As children of mothers with obesity are themselves at risk of obesity, we examined these relationships in a cohort of 482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT).
METHOD


Dietary patterns were derived using factor analysis of an 85-item food frequency questionnaire (FFQ). Eating behaviours were assessed using the Children's Eating Behaviour Questionnaire (CEBQ). Measures of body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage. Using adjusted regression analysis, we examined associations between dietary patterns, eating behaviours, and measures of body composition.
RESULTS


Three distinct dietary patterns were defined: ""healthy/prudent,"" ""African/Caribbean,"" and ""processed/snacking."" The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19). The ""African/Caribbean"" and the ""healthy/prudent"" patterns were associated with a lower arm circumference (β = -0.23 cm [-0.45 to -0.01]) and sum of skinfolds (β = -1.36 cm [-2.88 to -0.37]), respectively. Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety, were associated with lower arm and waist circumferences, WHO z scores, and obesity (all P < .05).
CONCLUSION


In children of mothers with obesity, those who had higher scores on a ""processed/snacking"" dietary pattern had greater odds of obesity. In contrast, slowness in eating was associated with lower measures of body composition. These novel findings highlight modifiable behaviours in high-risk preschool children which could contribute to public health strategies for prevention of childhood obesity.",2020,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","['482 three-year-old children of mothers with obesity from the UK Pregnancy Better Eating and Activity Trial (UPBEAT', 'preschool children', 'high-risk preschool children', '3-year-old children of mothers with obesity']",[],"['lower arm and waist circumferences, WHO z scores, and obesity', 'dietary patterns, eating behaviours, and body composition and adiposity', 'Eating behaviours', 'obesity', 'body composition included age-specific BMI cut-offs, WHO z scores, sum of skinfolds, waist and arm circumferences, and body fat percentage', 'dietary patterns, eating behaviours, and measures of body composition', 'Lower enjoyment of food and food responsiveness, and greater slowness in eating and satiety', ""Children's Eating Behaviour Questionnaire (CEBQ""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0611576,"The ""processed/snacking"" pattern was associated with greater odds of obesity; OR 1.53 (95% CI, 1.07-2.19).","[{'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}]",Pediatric obesity,['10.1111/ijpo.12608']
2797,31907840,Vision at a glance: The role of attention in processing object-to-object categorical relations.,"When viewing a scene at a glance, the visual and categorical relations between objects in the scene are extracted rapidly. In the present study, the involvement of spatial attention in the processing of such relations was investigated. Participants performed a category detection task (e.g., ""is there an animal"") on briefly flashed object pairs. In one condition, visual attention spanned both stimuli, and in another, attention was focused on a single object while its counterpart object served as a task-irrelevant distractor. The results showed that when participants attended to both objects, a categorical relation effect was obtained (Exp. 1). Namely, latencies were shorter to objects from the same category than to those from different superordinate categories (e.g., clothes, vehicles), even if categories were not prioritized by the task demands. Focusing attention on only one of two stimuli, however, largely eliminated this effect (Exp. 2). Some relational processing was seen when categories were narrowed to the basic level and were highly distinct from each other (Exp. 3), implying that categorical relational processing necessitates attention, unless the unattended input is highly predictable. Critically, when a prioritized (to-be-detected) object category, positioned in a distractor's location, differed from an attended object, a robust distraction effect was consistently observed, regardless of category homogeneity and/or of response conflict factors (Exp. 4). This finding suggests that object relations that involve stimuli that are highly relevant to the task settings may survive attentional deprivation at the distractor location. The involvement of spatial attention in object-to-object categorical processing is most critical in situations that include wide categories that are irrelevant to one's current goals.",2020,"Participants performed a category detection task (e.g., ""is there an animal"") on briefly flashed object pairs.",['Vision at a glance'],[],[],"[{'cui': 'C0042789', 'cui_str': 'Visual function'}]",[],[],,0.0263365,"Participants performed a category detection task (e.g., ""is there an animal"") on briefly flashed object pairs.","[{'ForeName': 'Nurit', 'Initials': 'N', 'LastName': 'Gronau', 'Affiliation': 'Department of Psychology & Cognitive Science Studies, Open University of Israel, Raanana, Israel. nuritgro@openu.ac.il.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01940-z']
2798,31942704,Studying the dynamics of visual search behavior using RT hazard and micro-level speed-accuracy tradeoff functions: A role for recurrent object recognition and cognitive control processes.,"Thanks to the work of Anne Treisman and many others, the visual search paradigm has become one of the most popular paradigms in the study of visual attention. However, statistics like mean correct response time (RT) and percent error do not usually suffice to decide between the different search models that have been developed. Recently, to move beyond mean performance measures in visual search, RT histograms have been plotted, theoretical waiting time distributions have been fitted, and whole RT and error distributions have been simulated. Here we promote and illustrate the general application of discrete-time hazard analysis to response times, and of micro-level speed-accuracy tradeoff analysis to timed response accuracies. An exploratory analysis of published benchmark search data from feature, conjunction, and spatial configuration search tasks reveals new features of visual search behavior, such as a relatively flat hazard function in the right tail of the RT distributions for all tasks, a clear effect of set size on the shape of the RT distribution for the feature search task, and individual differences in the presence of a systematic pattern of early errors. Our findings suggest that the temporal dynamics of visual search behavior results from a decision process that is temporally modulated by concurrently active recurrent object recognition, learning, and cognitive control processes, next to attentional selection processes.",2020,"However, statistics like mean correct response time (RT) and percent error do not usually suffice to decide between the different search models that have been developed.",[],[],[],[],[],[],,0.0437526,"However, statistics like mean correct response time (RT) and percent error do not usually suffice to decide between the different search models that have been developed.","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Panis', 'Affiliation': 'Experimental Psychology Unit, Faculty of Social Sciences, Technische Universität Kaiserslautern, Gottlieb-Daimler-Straße 47, 67663, Kaiserslautern, Germany. sven.panis@sowi.uni-kl.de.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Moran', 'Affiliation': 'Max Planck UCL Centre for Computational Psychiatry and Ageing Research, University College London, 10-12 Russell Square, London, WC1B 5EH, UK.'}, {'ForeName': 'Maximilian P', 'Initials': 'MP', 'LastName': 'Wolkersdorfer', 'Affiliation': 'Experimental Psychology Unit, Faculty of Social Sciences, Technische Universität Kaiserslautern, Gottlieb-Daimler-Straße 47, 67663, Kaiserslautern, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Experimental Psychology Unit, Faculty of Social Sciences, Technische Universität Kaiserslautern, Gottlieb-Daimler-Straße 47, 67663, Kaiserslautern, Germany.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01897-z']
2799,31974935,Delayed disengagement from irrelevant fixation items: Is it generally functional?,"In a circular visual search paradigm, the disengagement of attention is automatically delayed when a fixated but irrelevant center item shares features of the target item. Additionally, if mismatching letters are presented on these items, response times (RTs) are slowed further, while matching letters evoke faster responses (Wright, Boot, & Brockmole, 2015a). This is interpreted as a functional reason of the delayed disengagement effect in terms of deeper processing of the fixation item. The purpose of the present study was the generalization of these findings to unfamiliar symbols and to linear instead of circular layouts. Experiments 1 and 2 replicated the functional delayed disengagement effect with letters and symbols. In Experiment 3, the search layout was changed from circular to linear and only saccades from left to right had to be performed. We did not find supportive data for the proposed functional nature of the effect. In Experiments 4 and 5, we tested whether the unidirectional saccade decision, a potential blurring by adjacent items, or a lack of statistical power was the cause of the diminished effects in Experiment 3. With increased sample sizes, the delayed disengagement effect as well as its functional underpinning were now observed consistently. Taken together, our results support prior assumptions that delayed disengagement effects are functionally rooted in a deeper processing of the fixation items. They also generalize to unfamiliar symbols and linear display layouts.",2020,This is interpreted as a functional reason of the delayed disengagement effect in terms of deeper processing of the fixation item.,['Delayed disengagement from irrelevant fixation items'],[],[],"[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",[],[],,0.0206084,This is interpreted as a functional reason of the delayed disengagement effect in terms of deeper processing of the fixation item.,"[{'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Stefani', 'Affiliation': 'Institute of Psychology, General Psychology, Bundeswehr University Munich, Werner-Heisenberg-Weg 39, 85577, Neubiberg, Germany. maximilian.stefani@unibw.de.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Sauter', 'Affiliation': 'Institute of Psychology, General Psychology, Bundeswehr University Munich, Werner-Heisenberg-Weg 39, 85577, Neubiberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mack', 'Affiliation': 'Institute of Psychology, General Psychology, Bundeswehr University Munich, Werner-Heisenberg-Weg 39, 85577, Neubiberg, Germany.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01926-x']
2800,31974939,Visual and central attention share a capacity limitation when the demands for serial item selection in visual search are high.,"Visual and central attention are limited in capacity. In conjunction search, visual attention is required to select the items and to bind their features (e.g., color, form, size), which results in a serial search process. In dual-tasks, central attention is required for response selection, but because central attention is limited in capacity, response selection can only be carried out for one task at a time. Here, we investigated whether visual and central attention rely on a common or on distinct capacity limitations. In two dual-task experiments, participants completed an auditory two-choice discrimination Task 1 and a conjunction search Task 2 that were presented with an experimentally modulated temporal interval between them (stimulus onset asynchrony [SOA]). In Experiment 1, Task 2 was a triple conjunction search task. Each item consisted of a conjunction of three features, so that target and distractors shared two features. In Experiment 2, Task 2 was a plus conjunction search task, in which target and distractors shared the same four features. The hypotheses for conjunction search time were derived from the locus-of-slack method. While plus conjunction search was performed after response selection in Task 1, a small part of triple conjunction search was still performed in parallel to response selection in Task 1. However, the between-experiment comparison was not significant, indicating that both search tasks may require central attention. Taken together, the present study provides evidence that visual and central attention share a common capacity limitation when conjunction search relies strongly on serial item selection.",2020,"However, the between-experiment comparison was not significant, indicating that both search tasks may require central attention.",[],[],['Visual and central attention'],[],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0637759,"However, the between-experiment comparison was not significant, indicating that both search tasks may require central attention.","[{'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Reimer', 'Affiliation': 'Department of Psychology, Martin-Luther-Universität Halle-Wittenberg, Emil-Abderhalden-Str. 26-27, 06108, Halle (Saale), Germany. christina.reimer@psych.uni-halle.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schubert', 'Affiliation': 'Department of Psychology, Martin-Luther-Universität Halle-Wittenberg, Emil-Abderhalden-Str. 26-27, 06108, Halle (Saale), Germany.'}]","Attention, perception & psychophysics",['10.3758/s13414-019-01903-4']
2801,31415033,mTOR Inhibitor Therapy Diminishes Circulating CD8+ CD28- Effector Memory T Cells and Improves Allograft Inflammation in Belatacept-refractory Renal Allograft Rejection.,"BACKGROUND


Renal allograft rejection is more frequent under belatacept-based, compared with tacrolimus-based, immunosuppression. We studied kidney transplant recipients experiencing rejection under belatacept-based early corticosteroid withdrawal following T-cell-depleting induction in a recent randomized trial (Belatacept-based Early Steroid Withdrawal Trial, clinicaltrials.gov NCT01729494) to determine mechanisms of rejection and treatment.
METHODS


Peripheral mononuclear cells, serum creatinine levels, and renal biopsies were collected from 8 patients undergoing belatacept-refractory rejection (BRR). We used flow cytometry, histology, and immunofluorescence to characterize CD8 effector memory T cell (TEM) populations in the periphery and graft before and after mammalian target of rapamycin (mTOR) inhibition.
RESULTS


Here, we found that patients with BRR did not respond to standard antirejection therapy and had a substantial increase in alloreactive CD8 T cells with a CD28/DR/CD38/CD45RO TEM. These cells had increased activation of the mTOR pathway, as assessed by phosphorylated ribosomal protein S6 expression. Notably, everolimus (an mTOR inhibitor) treatment of patients with BRR halted the in vivo proliferation of TEM cells and their ex vivo alloreactivity and resulted in their significant reduction in the peripheral blood. The frequency of circulating FoxP3 regulatory T cells was not altered. Importantly, everolimus led to rapid resolution of rejection as confirmed by histology.
CONCLUSIONS


Thus, while prior work has shown that concomitant belatacept + mTOR inhibitor therapy is effective for maintenance immunosuppression, our preliminary data suggest that everolimus may provide an available means for effecting ""rescue"" therapy for rejections occurring under belatacept that are refractory to traditional antirejection therapy with corticosteroids and polyclonal antilymphocyte globulin.",2020,The frequency of circulating FoxP3 regulatory T cells was not altered.,"['patients with BRR', 'kidney transplant recipients experiencing rejection under belatacept-based early corticosteroid withdrawal following T-cell-depleting induction', '8 patients undergoing belatacept-refractory rejection (BRR']",['everolimus'],"['serum creatinine levels, and renal biopsies', 'frequency of circulating FoxP3 regulatory T cells', 'alloreactive CD8 T cells', 'Circulating CD8+ CD28- Effector Memory T Cells and Improves Allograft Inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0075747', 'cui_str': 'Lymphocyte antigen CD28'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",8.0,0.0223009,The frequency of circulating FoxP3 regulatory T cells was not altered.,"[{'ForeName': 'Cyd M', 'Initials': 'CM', 'LastName': 'Castro-Rojas', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Alzbeta', 'Initials': 'A', 'LastName': 'Godarova', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hummel', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Shields', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tremblay', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Alloway', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Jordan', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'E Steve', 'Initials': 'ES', 'LastName': 'Woodle', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hildeman', 'Affiliation': ""Division of Immunobiology, Cincinnati Children's Hospital, Cincinnati, OH.""}]",Transplantation,['10.1097/TP.0000000000002917']
2802,31612201,Serum Retinol and Risk of Overall and Site-Specific Cancer in the ATBC Study.,"Retinol, the most biologically active form of vitamin A, might influence cancer-related biological pathways. However, results from observational studies of serum retinol and cancer risk have been mixed. We prospectively examined serum retinol and risk of overall and site-specific cancer in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (n = 29,104 men), conducted in 1985-1993, with follow-up through 2012. Serum retinol concentration was measured using reverse-phase high-performance liquid chromatography. Cox proportional hazards models estimated the association between baseline serum retinol quintile and overall and site-specific cancer risk in 10,789 cases. After multivariable adjustment, higher serum retinol was not associated with overall cancer risk (highest vs. lowest quintile: hazard ratio (HR) = 0.97, 95% confidence interval (CI): 0.91, 1.03; P for trend = 0.43). Higher retinol concentrations were, however, associated with increased risk of prostate cancer (highest vs. lowest quintile: HR = 1.28, 95% CI: 1.13, 1.45; P for trend < 0.0001) and lower risk of both liver and lung cancers (highest vs. lowest quintile: for liver, HR = 0.62, 95% CI: 0.42, 0.91; P for trend = 0.004; and for lung, HR = 0.80, 95% CI: 0.72, 0.88; P for trend < 0.0001). No associations with other cancers were observed. Understanding the mechanisms that underlie these associations might provide insight into the role of vitamin A in cancer etiology.",2020,"After multivariable adjustment, higher serum retinol was not associated with overall cancer risk (highest vs. lowest quintile: hazard ratio (HR) = 0.97, 95% confidence interval (CI):","['n\xa0=\xa029,104 men), conducted in 1985-1993, with follow-up through 2012']","['Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study']","['Serum retinol concentration', 'serum retinol and risk of overall and site-specific cancer', 'lower risk of both liver and lung cancers', 'overall cancer risk', 'risk of prostate cancer', 'Serum Retinol and Risk of Overall and Site-Specific Cancer', 'Higher retinol concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0969677', 'cui_str': 'alpha Tocopherol'}, {'cui': 'C0053396', 'cui_str': 'Beta Carotene'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449604', 'cui_str': 'Specific site'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}]",29104.0,0.0694788,"After multivariable adjustment, higher serum retinol was not associated with overall cancer risk (highest vs. lowest quintile: hazard ratio (HR) = 0.97, 95% confidence interval (CI):","[{'ForeName': 'Manila', 'Initials': 'M', 'LastName': 'Hada', 'Affiliation': 'Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mondul', 'Affiliation': 'Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Weinstein', 'Affiliation': 'Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Demetrius', 'Initials': 'D', 'LastName': 'Albanes', 'Affiliation': 'Metabolic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}]",American journal of epidemiology,['10.1093/aje/kwz226']
2803,32049698,Aloe vera-Peppermint Gel (Veramin): An Effective Treatment for Mouth Dryness Among ICU Patients.,,2020,,['ICU Patients'],['Aloe vera-Peppermint Gel (Veramin'],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0110392,,"[{'ForeName': 'Stephanie Maxine', 'Initials': 'SM', 'LastName': 'Ross', 'Affiliation': 'Consultant, Complementary Integrative Therapies.'}]",Holistic nursing practice,['10.1097/HNP.0000000000000375']
2804,33030225,"Suitability of Low-Dose, Open Food Challenge Data to Supplement Double-Blind, Placebo-Controlled Data in Generation of Food Allergen Threshold Dose-Distributions.","Food allergen threshold dose-distributions are used in food allergen risk assessment to determine the level of risk within a food allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions. There has been a long-standing interest in determining threshold dose-distributions for different food allergens from a research and a risk management perspective. 1-3  More recently, allergen risk management programs utilizing population threshold dose-distributions to inform the decision making process have been endorsed by multiple international stakeholder groups and national agencies. 4-7  The interest shown by all stakeholders regarding this area of research had placed an emphasis on gathering as many data points, from as many foods, as possible to better inform allergen risk assessments and risk management.",2020,Food allergen threshold dose-distributions are used in food allergen risk assessment to determine the level of risk within a food allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions.,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0304595,Food allergen threshold dose-distributions are used in food allergen risk assessment to determine the level of risk within a food allergic population to a defined exposure amount of allergenic food protein and to help inform allergen risk management decisions.,"[{'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Remington', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Westerhout', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.'}, {'ForeName': 'Anthony E J', 'Initials': 'AEJ', 'LastName': 'Dubois', 'Affiliation': 'University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'W Marty', 'Initials': 'WM', 'LastName': 'Blom', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.'}, {'ForeName': 'Astrid G', 'Initials': 'AG', 'LastName': 'Kruizinga', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.'}, {'ForeName': 'Steve L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Food Allergy Research and Resource Program, University of Nebraska, Lincoln, USA.'}, {'ForeName': 'Geert F', 'Initials': 'GF', 'LastName': 'Houben', 'Affiliation': 'The Netherlands Organisation for Applied Scientific Research TNO, Utrecht, the Netherlands.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Baumert', 'Affiliation': 'Food Allergy Research and Resource Program, University of Nebraska, Lincoln, USA.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13753']
2805,32423746,The Effect of Vidian Neurectomy on Pulmonary Function in Patients with Allergic Rhinitis and Chronic Rhinosinusitis with Nasal Polyps.,"BACKGROUND


At present, the effect of operation intervention on pulmonary function is not clear in patients with allergic rhinitis and chronic rhinosinusitis with nasal polyps (AR&CRSwNP). This study was conducted to investigate the effect of vidian neurectomy on pulmonary function and airway hyperresponsiveness (AHR) in patients with AR&CRSwNP.
METHODS


The incidences of AHR, bronchial asthma (BA) and pulmonary function impairment in 112 patients with AR&CRSwNP were investigated. Subsequently, we evaluated the outcome of vidian neurectomy and its effect on pulmonary function and AHR. Furthermore, we explored the correlation between postoperative level of eosinophilic cationic protein (ECP) and the changes of pulmonary function indices or dose of methacholine.
RESULTS


In this study, the incidences of pulmonary function impairment, bronchial asthma, and AHR in patients with AR&CRSwNP were 61.61%, 69.64%, and 66.96%, respectively. Particularly, vidian neurectomy effectively alleviated nasal symptoms, improved pulmonary function, and reduced AHR in AR&CRSwNP patients. Furthermore, the postoperative level of ECP, IgE, Interleukin-4 and Interleukin-IL-5 was dramatically decreased, and there was an obvious inverse correlation between ECP level and pulmonary function index or dose of methacholine.
CONCLUSIONS


Vidian neurectomy is effective in alleviating nasal symptoms, improving pulmonary function, and reducing the risk of AHR of patients with AR&CRSwNP by decreasing the level of ECP.",2020,"Furthermore, the postoperative level of ECP, IgE, Interleukin-4 and Interleukin-IL-5 was dramatically decreased, and there was an obvious inverse correlation between ECP level and pulmonary function index or dose of methacholine.
","['patients with AR&CRSwNP', 'Patients with Allergic Rhinitis and Chronic Rhinosinusitis with Nasal Polyps', '112 patients with AR&CRSwNP', 'patients with allergic rhinitis and chronic rhinosinusitis with nasal polyps (AR&CRSwNP']","['vidian neurectomy', 'Vidian Neurectomy', 'operation intervention']","['pulmonary function and airway hyperresponsiveness (AHR', 'incidences of AHR, bronchial asthma (BA) and pulmonary function impairment', 'postoperative level of ECP, IgE, Interleukin-4 and Interleukin-IL-5', 'ECP level and pulmonary function index', 'pulmonary function', 'postoperative level of eosinophilic cationic protein (ECP', 'pulmonary function and AHR', 'nasal symptoms, improved pulmonary function, and reduced AHR', 'Pulmonary Function', 'pulmonary function impairment, bronchial asthma, and AHR', 'alleviating nasal symptoms, improving pulmonary function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0196652', 'cui_str': 'Nerve excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0858943', 'cui_str': 'Pulmonary function impairment'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0950373', 'cui_str': 'Eosinophilic cationic protein'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",112.0,0.0142842,"Furthermore, the postoperative level of ECP, IgE, Interleukin-4 and Interleukin-IL-5 was dramatically decreased, and there was an obvious inverse correlation between ECP level and pulmonary function index or dose of methacholine.
","[{'ForeName': 'Gulibositan', 'Initials': 'G', 'LastName': 'Maimaitiaili', 'Affiliation': ""ENT Department, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.""}, {'ForeName': 'Kayisaier', 'Initials': 'K', 'LastName': 'Kahaer', 'Affiliation': ""ENT Department, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""ENT Department, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China. Electronic address: xiao0nanshui@yeah.net.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""ENT Department, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China. Electronic address: bostan319@sina.com.""}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.04.024']
2806,33026143,"Design and Baseline Characteristics of the AMPLITUDE-O Cardiovascular Outcomes Trial of Efpeglenatide, a Weekly GLP-1 RA.","BACKGROUND


The effect of the weekly exendin-based glucagon-like peptide-1 receptor agonist (GLP1-RA) efpeglenatide on cardiovascular (CV) outcomes in high risk patients with type 2 diabetes (T2DM) with and without chronic kidney disease (CKD) is unknown.
METHODS


People with T2DM and HbA1c >7%, ≥ 18 years old with prior CV disease, or ≥ 50 years old with CKD (defined as an estimated glomerular filtration rate [eGFR] of 25 -59.9 ml/min/1.73m 2  ) and ≥ one additional CV risk factor were recruited. Participants were randomized in a 1:1:1 ratio, stratified by current, intended or neither current nor intended use of a sodium-glucose cotransporter-2 (SGLT2) inhibitor to receive weekly injections of efpeglenatide (4 mg or 6 mg) or masked placebo. The primary outcome is a major adverse CV event (MACE) defined as either non-fatal myocardial infarction, non-fatal stroke, or CV death. Secondary outcomes include a composite kidney outcome (new onset macroalbuminuria with an increase from baseline of ≥ 30% , sustained 40% decrease in eGFR, renal replacement therapy, or sustained eGFR < 15 ml per minute per 1.73 m²). The trial will continue until ≥ 330 participants have had a MACE outcome and the sample size was based on accruing enough outcomes to detect noninferiority of efpeglenatide versus placebo.
RESULTS


Recruitment of 4,076 participants (33% women, mean age 64.5 years) occurred between May 11, 2018 and April 25, 2019 at 344 sites in 28 countries. Mean baseline HbA1c was 8.9% (1.5), 31.6% had an eGFR <60 ml/min/1.73m 2  , 89.5% had previous CV disease, and 15.0% were on an SGLT2 inhibitor.
CONCLUSIONS


The AMPLITUDE O trial's results will inform the use of exendin-based GLP-1 RA to people with T2DM and high CV risk, with and without CKD, in the presence and absence of an SGLT2 inhibitor. This article is protected by copyright. All rights reserved.",2020,"Mean baseline HbA1c was 8.9% (1.5), 31.6% had an eGFR <60 ml/min/1.73m 2  , 89.5% had previous CV disease, and 15.0% were on an SGLT2 inhibitor.
","['18\u2009years old with prior CV disease, or ≥\u200950\u2009years old with CKD (defined as an estimated glomerular filtration rate [eGFR] of 25 -59.9 ml/min/1.73m 2  ) and ≥ one additional CV risk factor were recruited', '330 participants have had a MACE outcome and the sample size', 'People with T2DM and HbA1c >7%, ≥', 'high risk patients with type 2 diabetes (T2DM) with and without chronic kidney disease (CKD', '4,076 participants (33% women, mean age 64.5\u2009years) occurred between May 11, 2018 and April 25, 2019 at 344 sites in 28 countries']","['placebo', 'Efpeglenatide, a Weekly GLP-1 RA', 'sodium-glucose cotransporter-2 (SGLT2) inhibitor to receive weekly injections of efpeglenatide (4 mg or 6 mg) or masked placebo', 'exendin-based glucagon-like peptide-1 receptor agonist (GLP1-RA) efpeglenatide']","['major adverse CV event (MACE) defined as either non-fatal myocardial infarction, non-fatal stroke, or CV death', 'Mean baseline HbA1c', 'cardiovascular (CV) outcomes', 'composite kidney outcome (new onset macroalbuminuria with an increase from baseline of ≥\u200930% , sustained 40% decrease in eGFR, renal replacement therapy, or sustained eGFR']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",4076.0,0.370767,"Mean baseline HbA1c was 8.9% (1.5), 31.6% had an eGFR <60 ml/min/1.73m 2  , 89.5% had previous CV disease, and 15.0% were on an SGLT2 inhibitor.
","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Branch', 'Affiliation': 'Division of Cardiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Heenan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical & Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Nardev S', 'Initials': 'NS', 'LastName': 'Khurmi', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, NJ, USA.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, FL, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX, USA.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, BHF building, University of Glasgow, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14223']
2807,33026142,Restoration of nocturnal blood pressure dip and reduction of nocturnal blood pressure with evening anti-hypertensive medication administration in pediatric kidney transplant recipients: A pilot randomized clinical trial.,"Non-dipping and nocturnal hypertension are commonly found during ABPM in pediatric kidney transplant recipients. These entities are independently associated with increased cardiovascular disease risk in adults. Kidney transplant recipients aged 5-21 years with eGFR > 30 mL/min/1.73 m 2  and ABPM demonstrating non-dipping status and normal daytime BP were randomized to intervention (short acting BP medication added in the evening) or control (no medication change) in this pilot, randomized, open-label, blinded end-point clinical trial. ABPM, echocardiography, and PWV were performed at baseline, 3 months, and 6 months. The trial included 17 intervention and 16 control participants. Conversion to dipper status occurred in 53.3% vs 7.7% (P = .01) at 6 months for intervention and controls, respectively. Systolic dip was greater in the intervention group compared to controls (10.9 ± 4.5 vs 4.2 ± 4.6, P = .001), and average systolic nighttime BP was significantly lower in the intervention group (106 ± 8.3 vs 114.9 ± 9.5 mm Hg, P = .01) at 6 months. There were no significant differences in LVMI, PWV, or eGFR between groups. Within-group changes in the intervention group demonstrated improvements in non-dippers, dipping, systolic nighttime BP and nighttime BP load. Restoration of nocturnal dip and improvement in nocturnal BP were observed in the population following chronotherapy. Future studies are needed with larger sample sizes over a longer period of time to delineate the long-term effect of improved nocturnal dip on target organ damage.",2020,"Within-group changes in the intervention group demonstrated improvements in non-dippers, dipping, systolic nighttime BP and nighttime BP load.","['min/1.73\xa0m 2  and ABPM demonstrating non-dipping status and normal daytime BP', 'Kidney transplant recipients aged 5-21\xa0years with eGFR', '17 intervention and 16 control participants', 'pediatric kidney transplant recipients']",['intervention (short acting BP medication added in the evening) or control (no medication change'],"['nocturnal BP', 'ABPM, echocardiography, and PWV', 'Conversion to dipper status', 'Systolic dip', 'LVMI, PWV, or eGFR', 'average systolic nighttime BP', 'non-dippers, dipping, systolic nighttime BP and nighttime BP load', 'nocturnal blood pressure']","[{'cui': 'C0337426', 'cui_str': 'Dipping'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0337426', 'cui_str': 'Dipping'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0478071,"Within-group changes in the intervention group demonstrated improvements in non-dippers, dipping, systolic nighttime BP and nighttime BP load.","[{'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Sethna', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Lindsay G', 'Initials': 'LG', 'LastName': 'Grossman', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Preeta', 'Initials': 'P', 'LastName': 'Dhanantwari', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Gurusinghe', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Laney', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Frank', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Meyers', 'Affiliation': ""Division of Nephrology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Pediatric transplantation,['10.1111/petr.13854']
2808,33026154,"PREVIEW - Results from a 3-year randomised 2 x 2 factorial multinational trial investigating the role of protein, glycemic index and physical activity for prevention of type-2 diabetes.","AIM


To compare the impact of 2 long-term weight-maintenance diets: High-protein (HP), low-glycaemic index (GI) and moderate-protein (MP), moderate-GI, combined with high-intensity (HI) or moderate-intensity (MI) physical activity (PA) on incidence of type-2 diabetes (T2D) after rapid weight loss.
MATERIALS AND METHODS


A 3-year multicentre randomised trial in 8 countries using a 2x2 diet-by-PA factorial design. 8-weeks weight-reduction was followed by a 3-year randomised weight-maintenance phase. 2,326 adults (25-70 y, BMI≥25 kg/m 2  ) with pre-diabetes were enrolled. Primary endpoint was 3-year incidence of T2D analysed by diet treatment. Secondary outcomes included glucose, insulin, HbA1C, and body weight.
RESULTS


Total number of T2D cases was 62 and cumulative incidence rate 3.1%, with no significant differences between the 2 diets, PA, or their combination. T2D incidence was similar across intervention centres, irrespective of attrition. Signficantly fewer achieved normo-glycemia in the HP compared with the MP group (p<0.0001). At 3-years, normoglycemia was lowest in HP-HI (11.9%) compared with the other 3 groups (20.0-21.0%, p<0.05). There were no group differences in body weight change (-11% after 8-weeks weight reduction; -5% after 3 years weight maintenance) or in other secondary outcomes.
CONCLUSIONS


Three-year incidence of T2D was much lower than predicted and did not differ between diets, PA or their combination. Maintaining the target intakes of protein and GI over 3 years was difficult, but the overall protocol combining weight loss, healthy eating, and physical activity was successful in markedly reducing the risk of T2D. This is an important clinically relevant outcome. This article is protected by copyright. All rights reserved.",2020,Signficantly fewer achieved normo-glycemia in the HP compared with the MP group (p<0.0001).,"['2,326 adults (25-70 y, BMI≥25 kg/m 2  ) with pre-diabetes were enrolled']",[],"['glucose, insulin, HbA1C, and body weight', 'body weight change', 'T2D incidence', 'protein (HP), low-glycaemic index (GI) and moderate-protein (MP), moderate-GI, combined with high-intensity (HI) or moderate-intensity (MI) physical activity (PA) on incidence of type-2 diabetes (T2D', 'normo-glycemia', '3-year incidence of T2D']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439234', 'cui_str': 'year'}]",2326.0,0.108454,Signficantly fewer achieved normo-glycemia in the HP compared with the MP group (p<0.0001).,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of SCIENCE, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Pia Siig', 'Initials': 'PS', 'LastName': 'Vestentoft', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of SCIENCE, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, the University of Sydney, NSW, Australia.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mathjis', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, MD, Maastricht, the Netherlands.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Simpson', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Madrid, Spain.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering. Swansea, UK.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'NetUnion sarl, Lausanne, Switzerland.'}, {'ForeName': 'Jouko', 'Initials': 'J', 'LastName': 'Sundvall', 'Affiliation': 'Department of Government Services, Forensic Toxicology Unit, Biochemistry Laboratory, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, the University of Sydney, NSW, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Poppitt', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of SCIENCE, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Kirsi H', 'Initials': 'KH', 'LastName': 'Pietiläinen', 'Affiliation': 'Obesity Research Unit, Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, PO Box 63, 00014 University of Helsinki and Obesity Centre, Endocrinology, Abdominal Center, Helsinki University Hospital and University of Helsinki.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, MD, Maastricht, the Netherlands.'}, {'ForeName': 'Moira A', 'Initials': 'MA', 'LastName': 'Taylor', 'Affiliation': ""Division of Physiology, Pharmacology and Neuroscience, School of Life Sciences, Queen's Medical Centre, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.""}, {'ForeName': 'Santiago Navas', 'Initials': 'SN', 'LastName': 'Carretero', 'Affiliation': 'Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Svetoslav', 'Initials': 'S', 'LastName': 'Handjiev', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering. Swansea, UK.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Råman', 'Affiliation': 'Department of Government Services, Forensic Toxicology Unit, Biochemistry Laboratory, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'School of Life and Environmental Sciences and Charles Perkins Centre, the University of Sydney, NSW, Australia.'}, {'ForeName': 'Marta P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, School of Nutrition and Translational Research in Metabolism, MD, Maastricht, the Netherlands.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': 'MRC/ARUK Centre for Musculoskeletal Ageing Research, ARUK Centre for Sport, Exercise and Osteoarthritis, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'San-Cristobal', 'Affiliation': 'Precision Nutrition and Cardiometabolic Health. IMDEA-Food Institute (Madrid Institute for Advanced Studies), CEI UAM + CSIC, Madrid, Spain. Centre for Nutrition Research, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Nadka', 'Initials': 'N', 'LastName': 'Boyadjieva', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering. Swansea, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schlicht', 'Affiliation': 'Exercise and Health Sciences, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Human Nutrition Unit, School of Biological Sciences, Department of Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of SCIENCE, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14219']
2809,33026160,A Phase 3 Randomized Clinical Trial using Once-Weekly GLP-1 Receptor Agonist in Adolescents and Young Adults with Hypothalamic Obesity.,"AIMS


Hypothalamic injury often causes hypothalamic obesity (HO), a treatment-recalcitrant form of obesity. We evaluated the efficacy, safety, and tolerability of a glucagon-like peptide-1 receptor agonist (GLP1RA) in patients with HO.
MATERIALS AND METHODS


Two arm randomized multicenter double-blind placebo-controlled trial of 10-25-year-old people with hypothalamic injury following intracranial tumor and HO. Participants were randomized to once-weekly subcutaneous injections of GLP1RA exenatide 2mg (ExQW) or placebo for 36-weeks. Primary efficacy endpoint was 36-week % change (Δ) in BMI; secondary outcomes included Δbody composition (by dual-energy x-ray absorptiometry).
RESULTS


Forty-two participants were randomized to ExQW (n=23) or placebo (n=19). Participants were 5±2 years (mean±SD) post-diagnosis and development of HO (BMI 37.3±7.1 kg/m 2  ). In intention-to-treat analysis, the effect of 36-week ExQW vs. placebo on % Δ BMI was not significant (estimated treatment -1.7±1.8 %, 95% CI -4.1 to 0.6%, p=0.40); however total body fat mass was reduced (estimated treatment difference -3.1±1.4 kg, 95% CI -5.7 to -0.4kg, p=0.02). There was a significant reduction in waist circumference (estimated effect of treatment -3.5 (95%CI -5.5 to -1.6) cm, p=0.004). All patients treated with placebo increased percent adipose tissue, while 50% treated with ExQW had reductions (p<0.001). Mean HbA1c, glucose tolerance and serum lipids did not change significantly with therapy. ExQW was well tolerated. Most frequent adverse events were transient gastrointestinal disturbances (ExQW vs. placebo: nausea 6/23 vs. 3/18, vomiting 4/23 vs. 4/18, diarrhea 7/23 vs. 3/18).
CONCLUSIONS


GLP1RA is a promising and safe treatment to improve or stabilize HO in children and young adults. This article is protected by copyright. All rights reserved.",2020,There was a significant reduction in waist circumference (estimated effect of treatment -3.5 (,"['Participants were 5±2\u2009years (mean±SD) post-diagnosis and development of HO (BMI 37.3±7.1 kg/m 2  ', 'children and young adults', 'Adolescents and Young Adults with Hypothalamic Obesity', '10-25-year-old people with hypothalamic injury following intracranial tumor and HO', 'Forty-two participants', 'patients with HO']","['ExQW vs. placebo', 'GLP-1 Receptor Agonist', 'GLP1RA', 'placebo', 'glucagon-like peptide-1 receptor agonist (GLP1RA', 'ExQW', 'GLP1RA exenatide 2mg (ExQW) or placebo']","['Δbody composition (by dual-energy x-ray absorptiometry', 'efficacy, safety, and tolerability', 'total body fat mass', 'waist circumference', 'tolerated', 'Mean HbA1c, glucose tolerance and serum lipids', 'percent adipose tissue']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0271885', 'cui_str': 'Hypothalamic obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442857', 'cui_str': 'Hypothalamic injury'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1527390', 'cui_str': 'Intracranial tumor'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C4026820', 'cui_str': 'exenatide 2 MG'}]","[{'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",42.0,0.731804,There was a significant reduction in waist circumference (estimated effect of treatment -3.5 (,"[{'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Roth', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Perez', 'Affiliation': ""Department of Radiology, Seattle Children's and University of Washington, Seattle, WA.""}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Whitlock', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Elfers', 'Affiliation': ""Seattle Children's Research Institute, Seattle, WA.""}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Ashley H', 'Initials': 'AH', 'LastName': 'Shoemaker', 'Affiliation': 'Division of Pediatric Endocrinology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'M Jennifer', 'Initials': 'MJ', 'LastName': 'Abuzzahab', 'Affiliation': ""McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Minnesota, St. Paul, MN.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14224']
2810,33026166,Identifying the best regimen for primary eradication of Helicobacter pylori: analysis of 240 cases.,"The treatment regimen for the eradication of Helicobacter pylori may be best when therapy is susceptibility guided. However, it is unrealistic to use a strategy based on susceptibility testing to prioritize therapy for every patient in China. Empirical therapy of H. pylori is still widely used. The study was designed to discuss the best first-line treatment regimen depending on empirical therapy. The focal point of the study was the optimal length of the therapy. Also, the selection of antibiotics was discussed in the article. This was a prospective, randomized, non-inferiority trial. H. pylori-infected patients who have no previous eradication therapy were randomly assigned to the following: 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, and 220 mg of bismuth potassium citrate (BACPPI), administered twice a day for 10 or 14 days. The efficacy, side effects, and remission rate of clinical symptoms were determined. A total of 240 subjects were included in the study. The eradication rate with 14 and 10 days was essentially identical in both intention-to-treat (90.83% [95% CI, 86%-96%] vs. 87.50% [95% CI, 82%-93%]) and per-protocol (94.78% [95% CI, 91%-99%] vs. 92.11% [95% CI, 87%-97%]) analyses. Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment. Side effects were generally mild and similar between groups. Our results showed that a 10-day amoxicillin-clarithromycin-containing bismuth quadruple therapy may be recommended for the primary empirical treatment of H. pylori infection in Beijing, China.",2020,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"['H.\xa0pylori-infected patients who have no previous eradication therapy', '240 cases', 'A total of 240 subjects were included in the study']","['amoxicillin-clarithromycin-containing bismuth quadruple therapy', 'BACPPI-10', 'rabeprazole', 'amoxicillin, 500\xa0mg of clarithromycin, and 220\xa0mg of bismuth potassium citrate (BACPPI']","['eradication rate', 'Side effects', 'efficacy, side effects, and remission rate of clinical\xa0symptoms', 'Loss of appetite and belching symptoms']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}]",240.0,0.0356055,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qingyi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Domestic Department One, The Second Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fulian', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jizheng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital, Beijing, China.'}]",MicrobiologyOpen,['10.1002/mbo3.1120']
2811,33026307,Flashing In-curb LEDs and Beacons at Unsignalized Crosswalks and Driver's Visual Attention to Pedestrians During Nighttime.,"Driver's visual attention (eye movements) and driving behavior (kinematic data) were assessed when approaching an experimental crosswalk that included flashing white in-curb LED strips, flashing orange beacons, backlit ""Yield here to pedestrians"" vertical signs, and enhanced lighting when a staged pedestrian attempted to cross. An experimental condition in which all devices were active was compared with a control condition in which only enhanced lighting and backlit vertical signs were active. The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition. The introduction of flashing in-curb LED strips and flashing orange beacons proved to be very effective in increasing the nighttime safety of the pedestrian crossing. Practitioner Summary:  The study investigated the effects of flashing in-curb LED strips and beacons on driver's visual attention (eye movements) and speed when approaching a crosswalk during nighttime. The results showed that the combination of these flashing devices significantly increased yielding compliance and the distance of pedestrian detection.",2020,"The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition.",[],[],"[""driver's visual attention (eye movements"", ""motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements"", 'yielding compliance and the distance of pedestrian detection', ""Driver's visual attention (eye movements) and driving behavior (kinematic data""]",[],[],"[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.02562,"The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lantieri', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'Department of Psychology, Environmental Psychology Lab, University of Bologna, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vignali', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Italy.'}, {'ForeName': 'Ennia Mariapaola', 'Initials': 'EM', 'LastName': 'Acerra', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Italy.'}, {'ForeName': 'Pierclaudio', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': 'Department of Psychology, Environmental Psychology Lab, University of Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Simone', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Italy.'}]",Ergonomics,['10.1080/00140139.2020.1834149']
2812,33026311,Emotional and interpersonal mechanisms in community SSRI treatment of social anxiety disorder.,"BACKGROUND


Affective and interpersonal behavioural patterns characteristic of social anxiety disorder show improvement during treatment with serotonin agonists (e.g., selective serotonin reuptake inhibitors), commonly used in the treatment of social anxiety disorder. The present study sought to establish whether, during community psychopharmacological treatment of social anxiety disorder, changes in positive or negative affect and agreeable or quarrelsome behaviour mediate improvement in social anxiety symptom severity or follow from it.
METHODS


Adults diagnosed with social anxiety disorder ( n  = 48) recorded their interpersonal behaviour and affect naturalistically in an event-contingent recording procedure for 1-week periods before and during the first 4 months of treatment with paroxetine. Participants and treating psychiatrists assessed the severity of social anxiety symptoms monthly. A multivariate latent change score framework examined temporally lagged associations of change in affect and interpersonal behaviour with change in social anxiety symptom severity.
RESULTS


Elevated agreeable behaviour and positive affect predicted greater subsequent reduction in social anxiety symptom severity over the following month of treatment. Elevated negative affect, but not quarrelsome behaviour, predicted less subsequent reduction in symptom severity.
LIMITATIONS


Limitations included limited assessment of extreme behaviour (e.g., violence) that may have precluded examining the efficacy of paroxetine because of the lack of a placebo control group.
CONCLUSION


The present study suggests that interpersonal behaviour and affect may be putative mechanisms of action for serotonergic treatment of social anxiety disorder. Prosocial behaviour and positive affect increase during serotonergic treatment of social anxiety disorder. Specifically, modulating agreeable behaviour, positive affect and negative affect in individuals' daily lives may partially explain and refine clinical intervention.",2020,"Elevated negative affect, but not quarrelsome behaviour, predicted less subsequent reduction in symptom severity.
","['Adults diagnosed with social anxiety disorder ( n  = 48', 'social anxiety disorder', 'community SSRI treatment of social anxiety disorder']","['paroxetine', 'serotonin agonists (e.g., selective serotonin reuptake inhibitors']","['social anxiety symptom severity', 'severity of social anxiety symptoms monthly', 'interpersonal behaviour', 'Emotional and interpersonal mechanisms', 'Prosocial behaviour']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0162757', 'cui_str': 'Serotonin receptor agonist'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]",48.0,0.011767,"Elevated negative affect, but not quarrelsome behaviour, predicted less subsequent reduction in symptom severity.
","[{'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'Rappaport', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hunter', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Russell', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Pinard', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bleau', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Moskowitz', 'Affiliation': 'From the Department of Psychology, University of Windsor, Windsor, Ont., Canada (Rappaport); the Virginia Institute for Psychiatric and Behavioral Genetics, Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA (Rappaport); the Department of Psychology, McGill University, Montreal, Que., Canada (Rappaport, Russell, Moskowitz); the School of Psychology, Georgia Institute of Technology, Atlanta, GA, USA (Hunter); and the Department of Psychiatry, McGill University, Montreal, Que., Canada (Russell, Pinard, Bleau).'}]",Journal of psychiatry & neuroscience : JPN,['10.1503/jpn.190164']
2813,33026449,Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial.,"Importance


Palliative radiotherapy (RT) is generally recommended for older patients with esophageal squamous cell carcinoma (ESCC) with poor prognosis. A new combination treatment is therefore needed.
Objective


To assess the efficacy and toxicity of RT plus icotinib vs RT alone in older patients with ESCC.
Design, Setting, and Participants


This randomized, multicenter, open-label, phase II clinical trial was conducted in China, with enrollment between January 1, 2015, and October 31, 2016. Patients aged 70 years or older with clinical stage T2 to T4, N0/1, M0/1a unresectable (because of comorbidities, T4 disease, unresectable lymph node, or refused surgery) ESCC were randomized 1:1 to receive RT plus icotinib or RT alone. Radiation was prescribed at 60 Gy in 30 fractions in both groups, and icotinib was administered at a dosage of 125 mg 3 times a day in the RT plus icotinib group. The last follow-up was completed on June 30, 2019, and data were analyzed from July 1 to September 30, 2019.
Interventions


Patients were randomized to either RT plus icotinib or RT alone.
Main Outcomes and Measures


The primary end point was overall survival (OS). Treatment-related toxic effects were evaluated. Immunohistochemistry was performed to analyze epidermal growth factor receptor (EGFR) expression if available.
Results


A total of 127 patients (median age, 76 years [range, 70-91 years]; 76 men [59.8%]) were enrolled and were eligible for survival analysis. Median OS was 24.0 (95% CI, 22.2-25.8) months in the RT plus icotinib group vs 16.3 (95% CI, 13.8-18.8) months in the RT group (hazard ratio, 0.53; 95% CI, 0.33-0.87; P = .008). No difference was observed in grades 3 or 4 adverse events. Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
Conclusions and Relevance


In this randomized clinical trial, icotinib plus RT was well tolerated and improved OS in older patients with ESCC relative to RT alone. Patients with EGFR overexpression benefitted more from icotinib with RT.
Trial Registration


ClinicalTrials.gov Identifier: NCT02375581.",2020,"Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
","['China, with enrollment between January 1, 2015, and October 31, 2016', '127 patients (median age, 76 years [range, 70-91 years]; 76 men [59.8%]) were enrolled and were eligible for survival analysis', 'older patients with ESCC', 'Patients with EGFR overexpression benefitted more from icotinib with RT', 'Older Adults With Unresectable Esophageal Squamous Cell Carcinoma', 'older patients with esophageal squamous cell carcinoma (ESCC) with poor prognosis', 'Patients aged 70 years or older with clinical stage T2 to T4, N0/1, M0/1a unresectable (because of comorbidities, T4 disease, unresectable lymph node, or refused surgery', 'older patients with ESCC relative to RT alone']","['RT plus icotinib vs RT alone', 'icotinib plus RT', 'RT plus icotinib or RT alone', 'Palliative radiotherapy (RT', 'Icotinib With Concurrent Radiotherapy vs Radiotherapy']","['epidermal growth factor receptor (EGFR) expression', 'overall survival (OS', 'tolerated and improved OS', 'grades 3 or 4 adverse events', 'efficacy and toxicity', 'median overall survival', 'Median OS', 'toxic effects']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C2604307', 'cui_str': 'icotinib'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2604307', 'cui_str': 'icotinib'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",127.0,0.12861,"Patients with EGFR overexpression had a significantly better median overall survival (not reached vs 16.3 months [range, 2.6-45.1 months]; P = .03) in the RT plus icotinib group.
","[{'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': ""Department of Radiation Oncology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Medical Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Pharmacy, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Lishui Central Hospital, Lishui, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruifei', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Department of Bio-informatics, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Jiayang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, the Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian, China.""}, {'ForeName': 'Rongjing', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Pathology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Department of Radiation Oncology, Lishui Central Hospital, Lishui, China.'}, {'ForeName': 'Shixiu', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19440']
2814,33026490,Yoga effectively reduces fatigue and symptoms of depression in patients with different types of cancer.,"PURPOSE


Examine the effects of an 8-week yoga therapy on fatigue in patients with different types of cancer.
METHODS


A total of 173 cancer patients suffering from mild to severe fatigue were randomly allocated to yoga intervention (n = 84) (IG) versus waitlist control group (CG) (n = 88). Yoga therapy consisted of eight weekly sessions with 60 min each. The primary outcome was self-reported fatigue symptoms. Secondary outcomes were symptoms of depression and quality of life (QoL). Data were assessed using questionnaires before (T0) and after yoga therapy for IG versus waiting period for CG (T1).
RESULTS


A stronger reduction of general fatigue (P = .033), physical fatigue (P = .048), and depression (P < .001) as well as a stronger increase in QoL (P = .002) was found for patients who attended 7 or 8 sessions compared with controls. Within the yoga group, both higher attendance rate and lower T0-fatigue were significant predictors of lower T1-fatigue (P ≤ .001). Exploratory results revealed that women with breast cancer report a higher reduction of fatigue than women with other types of cancer (P = .016) after yoga therapy.
CONCLUSION


The findings support the assumption that yoga therapy is useful to reduce cancer-related fatigue, especially for the physical aspects of fatigue. Women with breast cancer seem to benefit most, and higher attendance rate results in greater reduction of fatigue.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00016034.",2020,"A stronger reduction of general fatigue (P = .033), physical fatigue (P = .048), and depression (P < .001) as well as a stronger increase in QoL (P = .002) was found for patients who attended 7 or 8 sessions compared with controls.","['Women with breast cancer', '173 cancer patients suffering from mild to severe fatigue', 'women with breast cancer', 'patients with different types of cancer']","['yoga intervention', 'yoga therapy', 'waitlist control group (CG']","['general fatigue', 'physical fatigue', 'symptoms of depression and quality of life (QoL', 'QoL', 'fatigue', 'self-reported fatigue symptoms', 'fatigue and symptoms of depression', 'attendance rate and lower T0-fatigue']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",173.0,0.0522831,"A stronger reduction of general fatigue (P = .033), physical fatigue (P = .048), and depression (P < .001) as well as a stronger increase in QoL (P = .002) was found for patients who attended 7 or 8 sessions compared with controls.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Zetzl', 'Affiliation': 'Interdisciplinary Center, Palliative Medicine, University Hospital Würzburg, Josef-Schneider-Str. 11, B1, 97080, Würzburg, Germany. Zetzl_T@ukw.de.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Interdisciplinary Center, Palliative Medicine, University Hospital Würzburg, Josef-Schneider-Str. 11, B1, 97080, Würzburg, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Pittig', 'Affiliation': 'Department of Psychology (Biological Psychology, Clinical Psychology, and Psychotherapy), University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Jentschke', 'Affiliation': 'Interdisciplinary Center, Palliative Medicine, University Hospital Würzburg, Josef-Schneider-Str. 11, B1, 97080, Würzburg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Roch', 'Affiliation': 'Interdisciplinary Center, Palliative Medicine, University Hospital Würzburg, Josef-Schneider-Str. 11, B1, 97080, Würzburg, Germany.'}, {'ForeName': 'Birgitt', 'Initials': 'B', 'LastName': 'van Oorschot', 'Affiliation': 'Interdisciplinary Center, Palliative Medicine, University Hospital Würzburg, Josef-Schneider-Str. 11, B1, 97080, Würzburg, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05794-2']
2815,33026544,Xenograft for anterior cruciate ligament reconstruction was associated with high graft processing infection.,"PURPOSE


To evaluate clinical ad radiological outcomes of anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft at 24-month minimum follow-up.
METHODS


66 patients undergoing arthroscopic ACL reconstruction were randomized into 2 groups: 34 allografts and 32 xenografts treated to attenuate the host immune response. Follow-up was 24-month minimum. Anterior knee stability was measured as KT - 1000 side-to-side laxity difference (respect to the contralateral healthy knee). Functional performance was assessed by one-legged hop test. Objective manual pivot-shift test and subjective (IKDC, Tegner and SF-36) outcomes were collected. MRI and standard X-Ray were performed.
RESULTS


61 subjects (32 allograft, 29 xenograft) were evaluated at 12 and 24 months. Six of the subjects in xenograft group (20.6%) got an infection attributed to a water-based pathogen graft contamination in processing. Intention-to-treat analysis (using the last observation carried forward imputation method) revealed higher KT - 1000 laxity in xenograft group at 24-month follow-up (P = .042). Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038). Per-protocol analysis (missing/contaminated subjects excluded) did not revealed clinical differences between groups. Tibial tunnel widening in the allograft group was low, whereas xenograft tunnel widening was within the expected range of 20-35% as reported in the literature. No immunological reactivity was associated to xenograft group.
CONCLUSIONS


High infection rate (20.6%) was reported in xenograft group. Both groups of patients achieved comparable clinical outcomes if missing/contaminated subjects are excluded. Improved harvesting/processing treatments in future studies using xenografts for ACL reconstruction are needed to reduce infection rate, otherwise xenograft should not be used in ACL reconstruction.
LEVEL OF EVIDENCE


Multicenter and double-blinded Randomized Controlled Clinical Trial, Level I.",2020,Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038).,"['66 patients undergoing arthroscopic ACL reconstruction', '61 subjects (32 allograft, 29 xenograft']",['anterior cruciate ligament (ACL) reconstruction with an immunochemically modified porcine patellar tendon xenograft controlled against human Achilles tendon allograft'],"['xenograft tunnel widening', 'immunological reactivity', 'Anterior knee stability', 'Tibial tunnel widening', 'Objective manual pivot-shift test and subjective (IKDC, Tegner and SF-36) outcomes', 'Functional performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C3669378', 'cui_str': 'Pivot shift test'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",66.0,0.030646,Also pivot-shift was higher in xenograft group at 12-month (P = .015) and 24-month follow-up (P = .038).,"[{'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Van Der Merwe', 'Affiliation': 'Sport Science Institute of S. Africa, Cape Town, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faunø', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Van Egmond', 'Affiliation': 'Dept. of Orthopaedic Surgery, Isala Klinieken, Zwolle, Netherlands.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Zaffagnini', 'Affiliation': 'IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy.'}, {'ForeName': 'Maurilio', 'Initials': 'M', 'LastName': 'Marcacci', 'Affiliation': 'IRCCS Humanitas University, Milano / former Istituto Ortopedici Rizzoli, University of Bologna, II Clinica Ortopedica, Bologna, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Cugat', 'Affiliation': 'Hospital Quiron, Artoscopia GC, Barcelona, Spain.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Verdonk', 'Affiliation': 'Dept. of Orthopaedic Surgery & Traumatology, Gent Univ. Hospital, Ghent, Belgium.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Ibañez', 'Affiliation': 'Clinica Cemtro, Orthopaedic Surgery & Traumatology, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Guillen', 'Affiliation': 'Clinica Cemtro, Orthopaedic Surgery & Traumatology, Madrid, Spain.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Marcheggiani Muccioli', 'Affiliation': 'IRCCS Istituto Ortopedici Rizzoli, University of Bologna, Lab. Biomeccanica - Via di Barbiano, 1/10, 40137, Bologna, Italy. marcheggianimuccioli@me.com.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00292-0']
2816,33026570,"Evaluation of the efficacy of masturbation on distal ureteral stones: a prospective, randomized, controlled study.","PURPOSE


To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.
MATERIAL AND METHODS


A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n = 43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n = 41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n = 44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.
RESULTS


The mean ages of the patients in groups 1, 2, and 3 were 37 ± 5.0, 37.6 ± 4.6, and 38.4 ± 6.8 years, respectively (p = 0.7). The mean stone size in each group was 6.93 ± 1.1 mm, 7.1 ± 0.9 mm, and 6.87 ± 1.1 mm, respectively (p = 0.4). Spontaneous passage rates in groups 1, 2, and 3 were 81.4%, 80.5%, and 43.2%, respectively, and were significantly higher in group 1 (p = 0.001) and group 2 (p = 0.001) when compared with group 3. Analgesic requirement in groups 1, 2, and 3 was 1.7 ± 0.6, 1.5 ± 0.6, and 1.8 ± 0.6 times per day, respectively, and was significantly lower in the tamsulosin group than in the control group (p = 0.004) CONCLUSION: Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size. Masturbating at least 3-4 times a week was as effective as tamsulosin. Masturbation and tamsulosin also reduced the need for ureterorenoscopic lithotripsy.",2020,Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size.,"['128 men with distal ureteral stones', 'mean ages of the patients in groups 1, 2, and 3 were 37\u2009±\u20095.0, 37.6\u2009±\u20094.6, and 38.4\u2009±\u20096.8\xa0years, respectively (p\u2009=\u20090.7', 'distal ureteral stones']","['standard medical therapy', 'tamsulosin', 'standard medical therapy alone']","['spontaneous passage of distal ureteral stones', 'Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy', 'mean stone size', 'Analgesic requirement', 'spontaneous expulsion of distal ureteral stones', 'Spontaneous passage rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517474', 'cui_str': '0.7'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",128.0,0.0334812,Masturbation and tamsulosin increased the spontaneous passage of distal ureteral stones 5-10 mm in size.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Turgut', 'Affiliation': 'Faculty of Health Science, Avrasya University, Trabzon, Turkey. drhasanturgut@hotmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sarıer', 'Affiliation': 'Department of Urology, Istinye University Medical Faculty, Istanbul, Turkey.'}]",International urology and nephrology,['10.1007/s11255-020-02672-y']
2817,33026630,The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine.,"INTRODUCTION


The phase 3 PREEMPT trials demonstrated efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. OnabotulinumtoxinA significantly reduced headache frequency from baseline vs. placebo at 24 weeks; however, this measure may not fully capture the benefits of treatment. We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes according to headache responder status.
METHODS


A post hoc analysis pooled 24-week data from the placebo-controlled, randomized, double-blind treatment phases of the PREEMPT trials. Patients were stratified by randomized treatment (onabotulinumtoxinA vs. placebo) and headache day responder status (responder vs. nonresponder). Headache day responders had a ≥ 50% headache day reduction from baseline measured at weeks 21-24. Outcomes evaluated were patient-reported reductions in moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire. Missing values were estimated using a modified last-observation-carried-forward approach.
RESULTS


In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), headache day responder rates were 308/688 (45%) for onabotulinumtoxinA- and 238/696 (34%) for placebo-treated patients. At 24 weeks compared with baseline, onabotulinumtoxinA nonresponders showed significantly (all P < 0.01) greater mean (standard error) reductions vs. placebo nonresponders in moderate-to-severe headache days (- 3.5 [0.2] vs. - 2.4 [0.2]) and Headache Impact Test scores (- 2.3 [0.3] vs. - 0.8 [0.2]), and greater mean improvements in Migraine-Specific Quality of Life Questionnaire domains (Restrictive, 8.8 [1.0] vs. 2.9 [0.8]; Preventive, 6.0 [1.0] vs. 1.8 [0.8]; Emotional, 8.5 [1.3] vs. 2.8 [1.1]). Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
CONCLUSIONS


Relative to placebo nonresponders, onabotulinumtoxinA nonresponders experienced significant reductions in moderate-to-severe headache days and disability and improvement in quality of life, implying that the full benefits of onabotulinumtoxinA are not captured by headache day reduction.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","['Headache Day Responder and Nonresponder Patients with Chronic Migraine', 'adults with chronic migraine']","['randomized treatment (onabotulinumtoxinA vs. placebo', 'onabotulinumtoxinA', 'placebo', 'OnabotulinumtoxinA vs. Placebo', 'OnabotulinumtoxinA']","['Moderate-to-severe headache day and headache impact differences', 'Headache Impact Test scores', 'Migraine-Specific Quality of Life Questionnaire domains', 'headache day responder rates', 'moderate-to-severe headache days and disability', 'headache frequency', 'moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire', 'quality of life', 'efficacy and tolerability']","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.433509,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Pain and therapy,['10.1007/s40122-020-00199-9']
2818,33026631,Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis.,"INTRODUCTION


The double-blind, phase 3 PREEMPT trials demonstrated the efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis evaluated the effect of onabotulinumtoxinA on clinically meaningful changes in headache severity, headache-related impact, and quality of life.
METHODS


Pooled, 24-week data were used to determine percentages of patients meeting responder criteria for the change in headache days (≥ 50% reduction in headache-day frequency), Headache Impact Test (HIT-6; ≥ 5-point improvement), MSQ Role Function-Restrictive (MSQ-RFR; ≥ 10.9-point improvement), and Average Daily Headache Severity (ADHS; ≥ 1-point improvement on a 4-point ordinal scale [0 = no pain, 3 = severe pain]).
RESULTS


In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), significantly more patients treated with onabotulinumtoxinA compared with placebo were responders on HIT-6 (40.8 vs. 25.3%), MSQ-RFR (59.0 vs. 40.2%), and ADHS (35.5 vs. 22.4%) measures, and achieved traditional ≥ 50% reduction in headache days (44.8 vs. 34.2%; all P < 0.001). At least one responder criterion was met by 72.1% and 56.6% of onabotulinumtoxinA- and placebo-treated patients, respectively; all four were met by 20.4% and 8.6%, respectively (P < 0.001). Linear regression analysis showed that approximately 20% of the variance in HIT-6 and MSQ-RFR improvement was explained by improvement in headache days.
CONCLUSIONS


Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life. While 45% of patients met responder criteria for monthly headache days, over 70% had clinically meaningful improvements on at least one outcome measure.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"CONCLUSIONS


Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.",['adults with chronic migraine'],"['onabotulinumtoxinA- and placebo', 'placebo', 'onabotulinumtoxinA']","['headache severity and headache-related impact, and improved quality of life', 'headache days', 'headache-day frequency), Headache Impact Test (HIT-6;\u2009≥\u20095-point improvement), MSQ Role Function-Restrictive (MSQ-RFR', 'ADHS', 'HIT-6 and MSQ-RFR improvement', '4-point ordinal scale [0\u2009=\u2009no pain, 3\u2009=\u2009severe pain', 'Average Daily Headache Severity (ADHS;\u2009≥', 'MSQ-RFR', 'efficacy and tolerability', 'headache severity, headache-related impact, and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.254152,"CONCLUSIONS


Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany. h.diener@uni-essen.de.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]",Pain and therapy,['10.1007/s40122-020-00198-w']
2819,33030354,"Treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine is comparable in patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec: a post-marketing safety study.","Objective:  To evaluate insulin treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice for Japanese patients with type 2 diabetes mellitus (T2DM) who switched from originator insulin glargine (100 U/mL) or insulin degludec treatment to GLY treatment. Methods:  The Insulin Treatment Satisfaction Questionnaire (ITSQ) was used to assess treatment satisfaction in a subgroup analysis of a post-marketing safety study. Hypoglycemia incidence rates and blood glucose control are also reported during the 12-month observation period for GLY-switched patients. Results:  Of 1104 patients with T2DM enrolled to participate, 565 patients switched from either insulin glargine U100/mL (n = 470) or insulin degludec (n = 95) to GLY. The mean total change from baseline to 3 months for total ITSQ score was 1.35 (95% confidence interval [CI] -0.13 to 2.83, p = 0.073) for patients who switched from insulin glargine and 2.63 (95% CI -1.43 to 6.70, p = 0.195) for patients who switched from insulin degludec to GLY treatment. The mean change from baseline to 12 months in hypoglycemia events reported per month was -0.04% (95% CI -0.12 to 0.03, p = 0.236) for patients who switched from insulin glargine and no change for patients who switched from insulin degludec (0.00, 95% CI -0.20 to 0.20, p = 1.000). Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients. Conclusions:  Treatment satisfaction does not change significantly in Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec. Safety and effectiveness over a 12-month period were similar in GLY-treated patients who switched from either insulin glargine or insulin degludec. ClinicalTrials.gov:  Not applicable.",2020,Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients.,"['Japanese patients with type 2 diabetes mellitus (T2DM) who switched from', 'Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec', '1104 patients with T2DM enrolled to participate', '565 patients switched from either', '100\u2009U/mL) or insulin degludec treatment to GLY treatment', 'patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec']","['insulin glargine or insulin degludec', 'biosimilar insulin glargine (GLY', 'originator insulin glargine', 'insulin glargine', 'insulin glargine U100/mL (n\u2009=\u2009470) or insulin degludec (n\u2009=\u200995) to GLY', 'biosimilar insulin glargine']","['hypoglycemia events', 'hemoglobin A1c and fasting plasma glucose', 'Hypoglycemia incidence rates and blood glucose control', 'Treatment satisfaction, safety, and effectiveness', 'total ITSQ score', 'mean total change', 'Insulin Treatment Satisfaction Questionnaire (ITSQ', 'Safety and effectiveness']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1104.0,0.0389723,Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Taki', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K., Kobe, Japan.'}, {'ForeName': 'Momoha', 'Initials': 'M', 'LastName': 'Koyanagi', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K., Kobe, Japan.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K., Kobe, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Shingaki', 'Affiliation': 'Medicines Development Unit-Japan, Eli Lilly Japan K. K., Kobe, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1834374']
2820,33030391,Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency.,"An oral test supplement increases serum human growth hormone (hGH) levels after acute administration in healthy adults. We investigated the mechanism for the increase in hGH and the effect of continued daily administration of the test supplement on measures of physical fitness and sleep efficiency. In Study 1, serum triiodothyronine (T3) was measured in samples from a prior placebo-controlled, double-blind study in which 16 healthy participants received both placebo and the test supplement in a crossover design; treatment order was randomized, and treatments were separated by a 1-week washout. In Study 2, physical fitness (VO 2  max) was measured at baseline and after 2 weeks of daily administration of the test supplement ( N  = 12 healthy participants). Study 3 assessed daily sleep onset latency and time awake during 3 weeks of daily administration of the test supplement ( N  = 15 healthy participants). A fall from baseline in T3 was observed with placebo (-6.1 ± 8.5 ng/dL,  P  = .01). Of note, the change in T3 was smaller with the test supplement (-3.3 ± 10.7 ng/dL,  P  = not significant) but was not statistically different from placebo. Mean VO 2  max increased by 6% from baseline after 2 weeks ( P  = .02). Sleep-onset latency and time awake during the night were reduced from baseline to week 3 by 22% and 65%, respectively ( P  = .01 and  P  = .02). The conservation of T3 levels suggests that the mechanism for increased hGH secretion by the test supplement is through somatostatin inhibition. Furthermore, pilot studies indicated that daily administration of the supplement improved physical fitness and sleep efficiency from baseline, effects consistent with increased endogenous hGH release. Clinical Trial Registration No. NCT02987868.",2020,"Sleep-onset latency and time awake during the night were reduced from baseline to week 3 by 22% and 65%, respectively ( P  = .01 and  P  = .02).","[' N \u2009=\u200915 healthy participants', '16 healthy participants received both', 'healthy adults']","['placebo', 'test supplement']","['Physical Fitness and Sleep Efficiency', 'hGH secretion', 'Sleep-onset latency and time awake during the night', 'daily sleep onset latency and time awake', 'Mean VO 2  max', 'serum human growth hormone (hGH) levels', 'physical fitness and sleep efficiency', 'physical fitness (VO 2  max', 'serum triiodothyronine (T3']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}]",16.0,0.259719,"Sleep-onset latency and time awake during the night were reduced from baseline to week 3 by 22% and 65%, respectively ( P  = .01 and  P  = .02).","[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Heaton', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Kelly Statistical Consulting, Carlsbad, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Charmaine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}]",Journal of medicinal food,['10.1089/jmf.2020.0109']
2821,33030398,Impact of Delay in Appendectomy on the Outcome of Appendicitis: A Post Hoc Analysis of an EAST Multicenter Study.,"Background:  Association between time-to-appendectomy and clinical outcomes is controversial with conflicting data regarding risk of perforation. The purpose of this study was to explore the associations between in-hospital delay in treatment of simple appendicitis with the incidence of complicated appendicitis discovered at appendectomy.  Methods:  The Eastern Association for the Surgery of Trauma (EAST) Multicenter Study of the Treatment of Appendicitis in America: Acute, Perforated, and Gangrenous (MUSTANG) database was queried and patients with acute appendicitis diagnosed on imaging were included. Upgrade was defined as gangrenous or perforated finding at appendectomy. Time intervals from emergency department (ED) triage to appendectomy were recorded in six-hour groups. Upgrade percentage for each group was presented and rates of a composite end point (30-day incidence of surgical site infection, abscess, wound complication, Clavien-Dindo complication, secondary intervention, ED visit, hospital re-admission, and mortality) were compared with Bonferroni correction to determine statistical significance (p = 0.05/9 = 0.005).  Results:  Of 3,004 included subjects, 484 (16%) experienced upgrade at appendectomy. Upgrade rates (%, 95% confidence interval [CI]) were: group 0-6 hours, 17% (95% CI, 14-19); group 6-11 hours, 15% (95% CI, 13-17%); group 12-17 hours, 16% (95% CI, 13-19); group 18-23 hours, 17% (95% CI, 12-23); group 24-29 hours, 30% (95% CI, 20-43); and group 30+ hours, 24% (95% CI, 14-37) (p = 0.014, NS by Bonferroni). Of 484 subjects with upgrade, 200 (41%; 95% CI, 37-46) had a worse composite outcome compared with 518 (21%; CI, 19-22) of 2,520 subjects with no upgrade (p < 0.001). The upgrade group was older (49 ± 17 years vs 39 ± 16 years), had a higher Charlson comorbidity index (CCI; 1.6 ± 1.9 vs 0.7 ± 1.4) and was more likely to have positive smoking history (20% vs 14%), and prior surgery (30% vs 22%; p < 0.001).  Conclusions:  We propose that ≥24-hour delay from ED triage to appendectomy is not associated with increased rate of severity upgrade from simple to complicated appendicitis. When upgrade occurs, it is correlated with older age, higher CCI, smoking history, and prior surgery and is associated with worse clinical outcomes.",2020,"The upgrade group was older (49 ± 17 years vs 39 ± 16 years), had a higher Charlson comorbidity index (CCI; 1.6 ± 1.9 vs 0.7 ± 1.4) and was more likely to have positive smoking history (20% vs 14%), and prior surgery (30% vs 22%; p < 0.001).  ","['The Eastern Association for the Surgery of Trauma (EAST', 'patients with acute appendicitis diagnosed on imaging were included', '3,004 included subjects, 484 (16%) experienced upgrade at appendectomy', 'simple appendicitis with the incidence of complicated appendicitis discovered at appendectomy', 'Appendicitis', 'Appendicitis in America']",[],"['rates of a composite end point (30-day incidence of surgical site infection, abscess, wound complication, Clavien-Dindo complication, secondary intervention, ED visit, hospital re-admission, and mortality', 'positive smoking history', 'higher Charlson comorbidity index', 'Time intervals from emergency department (ED) triage to appendectomy', 'Upgrade rates']","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0002454', 'cui_str': 'America'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",3004.0,0.105984,"The upgrade group was older (49 ± 17 years vs 39 ± 16 years), had a higher Charlson comorbidity index (CCI; 1.6 ± 1.9 vs 0.7 ± 1.4) and was more likely to have positive smoking history (20% vs 14%), and prior surgery (30% vs 22%; p < 0.001).  ","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdul Jawad', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Cioci', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Urrechaga', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Saskya', 'Initials': 'S', 'LastName': 'Byerly', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Rattan', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Gerd Daniel', 'Initials': 'GD', 'LastName': 'Pust', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Namias', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'D Dante', 'Initials': 'DD', 'LastName': 'Yeh', 'Affiliation': 'Division of Trauma & Surgical Critical Care, DeWitt Daughtry Family Department of Surgery, Jackson Memorial Hospital/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Surgical infections,['10.1089/sur.2020.219']
2822,33030412,Acute Effects of Exercise on Risk-Taking: Different Responses in Males and Females.,"In recent years there has been great interest in the effects of exercise on cognition, but few have investigated whether physical activity influences risk-taking.  Purpose : To investigate the effects of acute moderate to vigorous exercise on risky decision-making.  Methods : Healthy (free of psychological or neurological conditions), recreationally active males and females ( n  = 20, 50% females, mean age = 22.4 years, sd = 2.48) performed either a 30-min bout of cycling at 50% to 60% of their maximal power output or watched a neutral film over the course of two laboratory visits (repeated measures, randomized crossover design). Following the interventions, participants completed computerized behavioral tasks: the Balloon-Analogue Risk Task (BART), the Risky Gains Task, and the STOP-IT task and provided saliva samples (pre and post) to measure changes in cortisol.  Results : There was a significant interaction between sex and condition ( p  = .01, η p   2  = .3) for one of the risk-taking outcomes of the BART (number of explosions). Females exploded fewer balloons post-exercise. Performance on the other tasks did not change significantly between conditions (all  p  > .05). Cortisol increased significantly following exercise and responses did not differ between males and females. Considering cortisol change post-exercise similarly resulted in a significant sex by condition interaction ( p  = .005, η p   2  = .44), with males exploding more balloons and females exploding fewer post-exercise.  Conclusion : Acute exercise appears to have differing effects on males and females. Exercise resulted in risk seeking in males and risk aversion in females as measured by the BART.",2020,Performance on the other tasks did not change significantly between conditions (all  p  > .05).,"['Healthy (free of psychological or neurological conditions), recreationally active males and females ( n  =\xa020, 50% females, mean age\xa0=\xa022.4\xa0years, sd\xa0=\xa02.48', 'Males and Females', 'males and females']","['computerized behavioral tasks: the Balloon-Analogue Risk Task (BART), the Risky Gains Task, and the STOP-IT task', 'vigorous exercise', 'Exercise', '30-min bout of cycling at 50% to 60% of their maximal power output or watched a neutral film']","['Risk-Taking', 'Cortisol', 'risky decision-making', 'risk seeking in males and risk aversion']","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}]",,0.0420363,Performance on the other tasks did not change significantly between conditions (all  p  > .05).,"[{'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Thomson', 'Affiliation': 'University of the Fraser Valley.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaetz', 'Affiliation': 'University of the Fraser Valley.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rastad', 'Affiliation': 'University of the Fraser Valley.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1822984']
2823,33030436,Effect of Spatial Disorientation in a Virtual Environment on Gait and Vital Features in Patients with Dementia: Pilot Single-Blind Randomized Control Trial.,"BACKGROUND


Orientation deficits are among the most devastating consequences of early dementia. Digital navigation devices could overcome these deficits if adaptable to the user's needs (ie, provide situation-aware, proactive navigation assistance). To fulfill this task, systems need to automatically detect spatial disorientation from sensors in real time. Ideally, this would require field studies consisting of real-world navigation. However, such field studies can be challenging and are not guaranteed to cover sufficient instances of disorientation due to the large variability of real-world settings and a lack of control over the environment.
OBJECTIVE


Extending a foregoing field study, we aim to evaluate the feasibility of using a sophisticated virtual reality (VR) setup, which allows a more controlled observation of disorientation states and accompanying behavioral and physiological parameters in cognitively healthy older people and people with dementia.
METHODS


In this feasibility study, we described the experimental design and pilot outcomes of an ongoing study aimed at investigating the effect of disorientation on gait and selected physiological features in a virtual laboratory. We transferred a real-world navigation task to a treadmill-based virtual system for gait analysis. Disorientation was induced by deliberately manipulating landmarks in the VR projection. Associated responses in motion behavior and physiological parameters were recorded by sensors. Primary outcomes were variations in motion and physiological parameters, frequency of disorientation, and questionnaire-derived usability estimates (immersion and perceived control of the gait system) for our population of interest. At this time, the included participants were 9 cognitively healthy older participants [5/9 women, 4/9 men; mean age 70 years, SD 4.40; Mini-Mental State Examination (MMSE) mean 29, SD 0.70) and 4 participants with dementia (2/4 women, 2/4 men; mean age 78 years, SD 2.30 years; MMSE mean 20.50, SD 7.54). Recruitment is ongoing, with the aim of including 30 cognitively healthy older participants and 20 participants with dementia.
RESULTS


All 13 participants completed the experiment. Patients' route was adapted by shortening it relative to the original route. Average instances of disorientation were 21.40, 36.50, and 37.50 for the cognitively healthy older control, cognitively healthy older experimental participants, and participants with dementia, respectively. Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment. Variations were also observed in motion and physiological parameters during instances of disorientation.
CONCLUSIONS


This study presents the first feasibility outcomes of a study investigating the viability of using a sophisticated VR setup, based on an earlier real-world navigation study, to study spatial disorientation among cognitively healthy older people and people with dementia. Preliminary outcomes give confidence to the notion that our setup can be used to assess motion and physiological markers of disorientation, even in people with cognitive decline.
TRIAL REGISTRATION


ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT04134806.",2020,"Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment.","['cognitively healthy older control, cognitively healthy older experimental participants, and participants with dementia, respectively', '30 cognitively healthy older participants and 20 participants with dementia', 'people with cognitive decline', 'cognitively healthy older people and people with dementia', 'participants were 9 cognitively healthy older participants [5/9 women, 4/9 men; mean age 70 years, SD 4.40; Mini-Mental State Examination (MMSE) mean 29, SD 0.70) and 4 participants with dementia (2/4 women, 2/4 men; mean age 78 years, SD 2.30 years; MMSE mean 20.50, SD 7.54', 'Patients with Dementia']","['Spatial Disorientation', 'sophisticated virtual reality (VR) setup', 'Digital navigation devices']","['motion behavior and physiological parameters', 'Gait and Vital Features', 'variations in motion and physiological parameters, frequency of disorientation, and questionnaire-derived usability estimates (immersion and perceived control of the gait system']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0422893', 'cui_str': 'Spatial disorientation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",9.0,0.132761,"Questionnaire outcomes indicated that participants experienced adequate usability and immersion; 4.30 for presence, 3.73 for involvement, and 3.85 for realism of 7 possible points, indicating a good overall ability to cope with the experiment.","[{'ForeName': 'Chimezie O', 'Initials': 'CO', 'LastName': 'Amaefule', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüdtke', 'Affiliation': 'Institute of Visual & Analytic Computing, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirste', 'Affiliation': 'Institute of Visual & Analytic Computing, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany.'}]",JMIR serious games,['10.2196/18455']
2824,33030515,Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial.,"Importance


To our knowledge, this is the first randomized trial in sex cord-stromal tumors, and it establishes weekly paclitaxel as standard-of-care therapy after platinum-based therapy in this setting.
Objective


To determine the efficacy of weekly paclitaxel with or without bevacizumab as treatment for relapsed sex cord-stromal tumors and evaluate whether the addition of bevacizumab to weekly paclitaxel improves 6-month progression-free rate.
Design, Setting, and Participants


This open-label, academic, international, randomized phase 2 trial (ALIENOR) was conducted at 28 referral centers in France, Germany, Italy, Japan, and Belgium in collaboration with the Rare Tumor committee of the Gynecologic Cancer InterGroup and used an adaptive bayesian design. It included 60 women with sex cord-stromal tumors that had relapsed after at least 1 platinum-based chemotherapy. Enrollment occurred from 2013 to 2016, and the final analysis database lock was on March 27, 2020 (median follow-up, 38.9 months).
Interventions


Participants were randomized to receive either paclitaxel (80 mg/m2, days 1, 8, and 15 every 4 weeks) alone or paclitaxel with bevacizumab (10 mg/kg, every 2 weeks) for 6 cycles followed by maintenance bevacizumab (15 mg/kg, every 3 weeks) for up to 1 year or until progression or unacceptable toxicity. Crossover to bevacizumab was permitted after progression during or following paclitaxel alone.
Main Outcomes and Measures


Six-month progression-free rate.
Results


Sixty patients (predominantly with granulosa cell tumors) were randomized, 32 to receive single-agent paclitaxel (median [interquartile range] age at inclusion, 60 [53-64] years) and 28 to receive paclitaxel-bevacizumab (median [interquartile range] age at inclusion, 55 [47-61] years; 1 did not receive treatment). The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab. The bayesian estimate for the probability that the 6-month progression-free rate distribution was higher with the combination than with paclitaxel alone was 57%, less than the predefined superiority threshold. The objective response rate increased from 25% (95% CI, 12%-43%) to 44% (95% CI, 26%-65%) with the addition of bevacizumab. One patient discontinued combination therapy within 6 months because of toxicity.
Conclusions and Relevance


Weekly paclitaxel is a new option for relapsed sex cord-stromal tumors. In this international randomized clinical trial of patients with relapsed sex cord-stromal tumors unsuitable for surgery, adding bevacizumab to weekly paclitaxel does not improve clinical benefit.
Trial Registration


ClinicalTrials.gov Identifier: NCT01770301.",2020,"The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab.","['patients with relapsed sex cord-stromal tumors unsuitable for surgery, adding', '28 referral centers in France, Germany, Italy, Japan, and Belgium in collaboration with the Rare Tumor committee of the Gynecologic Cancer InterGroup and used an adaptive bayesian design', 'Patients', 'median [interquartile range] age at inclusion, 60 [53-64] years) and 28 to receive', 'Sixty patients (predominantly with granulosa cell tumors', '60 women with sex cord-stromal tumors that had relapsed after at least 1 platinum-based chemotherapy', 'With Relapsed Ovarian Sex Cord-Stromal Tumors', 'relapsed sex cord-stromal tumors']","['paclitaxel with bevacizumab', 'paclitaxel', 'Weekly Paclitaxel With or Without Bevacizumab', 'bevacizumab', 'paclitaxel-bevacizumab', 'bevacizumab to weekly paclitaxel', 'paclitaxel with or without bevacizumab', 'single-agent paclitaxel', 'maintenance bevacizumab']","['Measures\n\n\nSix-month progression-free rate', '6-month progression-free rate distribution', '6-month progression-free rate', 'estimated 6-month progression-free rate', 'Progression-Free Rate', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0206724', 'cui_str': 'Sex cord-stromal tumor'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018206', 'cui_str': 'Granulosa cell tumor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0600113', 'cui_str': 'Sex cord tumor of ovary'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",60.0,0.232113,"The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'GINECO and Centre Léon Bérard, University Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'AGO Study Group and Ev Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'MITO and Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'GINECO and Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'BGOG and University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'GOTIC and Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'GINECO and Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'AGO Study Group and Gyneco-Oncological Practice, Hannover, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'GINECO and Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Chevalier-Place', 'Affiliation': 'GINECO and Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schnelzer', 'Affiliation': 'AGO Study Group and Frauenklinik Technical University Munich, Munich, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'MITO and Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Selle', 'Affiliation': 'GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'AGO Study Group and Medical University of Berlin, Charité-CVK, Berlin, Germany.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Brocard', 'Affiliation': 'GINECO and Centre Oncologie de Gentilly, Nancy, France.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mangili', 'Affiliation': 'MITO and Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pautier', 'Affiliation': 'GINECO and Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'MITO and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Provansal', 'Affiliation': 'GINECO and Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Pierre-Etienne', 'Initials': 'PE', 'LastName': 'Heudel', 'Affiliation': 'GINECO and Centre Léon Bérard, Lyon, France.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4574']
2825,33030563,"The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial.","We conducted a randomized placebo-controlled double-blinded clinical trial of MK-7 or placebo daily for 3 years in postmenopausal women with osteopenia. BMD decreased at all sites without differences between the MK-7 and placebo-treated women. Changes in bone turnover markers and microstructure were similar between the two groups.
INTRODUCTION


Vitamin K is a cofactor in the carboxylation of osteocalcin (OC) and carboxylated OC promotes mineralization of bone. Clinical studies suggest that vitamin K2 prevents bone loss. The aim of the study was to investigate the effect of vitamin K2 as an add-on to calcium and vitamin D supplementation on osteocalcin, bone mass, and microarchitecture in postmenopausal women.
METHODS


We conducted a randomized placebo-controlled double-blinded clinical trial, including 142 postmenopausal women with osteopenia who received vitamin K2 (375 μg MK-7) or placebo daily for 3 years. Both groups received vitamin D3 (38 μg/day) and calcium (800 mg/day). We measured bone turnover markers in serum and bone mineral density and microarchitecture by DXA and HRpQCT.
RESULTS


Undercarboxylated osteocalcin decreased in the MK-7-group (- 65.2 ± 23.5%) (mean ± SD) compared with the placebo group (- 0.03 ± 38.5%), p < 0.01 after 1 year. After 3 years, aBMD decreased at all sites without differences between the MK-7 and placebo-treated women (p > 0.09). aBMD decreased at the total hip by 1.5 ± 2.5% and 2.4 ± 2.7% in the MK-7 and the placebo groups, respectively, at the femoral neck by 1.5 ± 3.5% and 1.0 ± 5.0% in the MK-7 and the placebo groups, respectively, and at the lumbar spine by 1.8 ± 3.9% and 1.1 ± 3.1% in the MK-7 and the placebo groups, respectively. Changes in bone turnover markers were also similar between the two groups.We have previously reported improved microarchitecture with MK-7 after 1 year. However, changes in microstructure over 3 years were similar between the two groups, as assessed by both HRpQCT and DXA trabecular bone score.
CONCLUSION


Treatment with MK-7 375 μg daily as an add-on to calcium and vitamin D increased carboxylation of osteocalcin. However, treatment of postmenopausal women with osteopenia for 3 years did not affect biochemical markers of bone turnover, bone mineral density, or bone microarchitecture.
TRIAL REGISTRATION


The study was registered at Clinicaltrial.gov : NCT01922804 .",2020,"After 3 years, aBMD decreased at all sites without differences between the MK-7 and placebo-treated women (p > 0.09).","['postmenopausal women with osteopenia for 3\xa0years', 'postmenopausal women', '142 postmenopausal women with osteopenia who received', 'daily for 3\xa0years', 'postmenopausal women with osteopenia']","['vitamin K2 (375\xa0μg MK-7) or placebo', 'vitamin K2', 'MK-7 or placebo', 'calcium and vitamin D supplementation', 'vitamin D3', 'placebo', 'Vitamin K', 'vitamin MK-7', 'calcium']","['osteocalcin, bone mass, and microarchitecture', 'aBMD', 'bone turnover markers', 'HRpQCT and DXA trabecular bone score', 'Undercarboxylated osteocalcin', 'bone turnover, bone mineral density, or bone microarchitecture', 'bone mineral density and microarchitecture', 'bone turnover markers and microstructure', 'BMD', 'bone loss']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0078382', 'cui_str': 'vitamin MK 7'}]","[{'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",142.0,0.637735,"After 3 years, aBMD decreased at all sites without differences between the MK-7 and placebo-treated women (p > 0.09).","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Rønn', 'Affiliation': 'Aarhus University Hospital, Palle Juul-Jensen Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harsløf', 'Affiliation': 'Aarhus University Hospital, Palle Juul-Jensen Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Oei', 'Affiliation': 'Aarhus University Hospital, Palle Juul-Jensen Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Aarhus University Hospital, Palle Juul-Jensen Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Palle Juul-Jensen Boulevard 99, 8200, Aarhus N, Denmark. bente.langdahl@aarhus.rm.dk.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05638-z']
2826,33030582,Efficacy and safety of oral magnesium supplementation in reducing febrile neutropenia episodes in children with solid tumors treated with cisplatin-based chemotherapy: randomized clinical trial.,"PURPOSE


Hypomagnesemia has been associated with febrile neutropenia (FN) in pediatric patients receiving cisplatin-based chemotherapy (CDDPBC). The primary aim was to determine whether oral magnesium supplementation reduces FN episodes in pediatric patients with solid tumors treated with CDDPBC.
METHOD


This randomized clinical trial, with open-label, single-center, parallel group and superiority design was conducted in Hospital Infantil de Mexico Federico Gomez at Mexico City. Children ≥ 9 years with solid tumors that were to receive a CDDPBC cycle were invited to participate. Each chemotherapy cycle with CDDPBC was randomly assigned to receive oral magnesium supplementation (250 mg/day) or not receive magnesium supplementation (control group). Efficacy was determined by relative risks (RR) with 95% confidence intervals (95% CI) as well as with numbers needed to treat (NNT). Active surveillance was conducted to assess safety in both groups. Analyses were carried out by intention to treat. ClinicalTrials.gov number NCT03449693.
RESULTS


One hundred and one chemotherapy cycles with CDDPBC were analyzed (50 in the magnesium supplement arm and 51 in control group). Baseline clinical characteristics were similar comparing both groups. Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4]. In the supplemented group, patients had fewer episodes of septic shock secondary to FN [RR 0.43, (95% CI 0.02-0.94), NNT = 6] and FN appeared on average 5 days later (p = 0.031). Hypomagnesemia episodes and adverse events were similar across both groups.
CONCLUSION


Oral supplementation with magnesium reduces FN episodes neutropenia in pediatric patients with solid tumors treated with CDDPBC.",2020,"Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4].","['9\xa0years with solid tumors that were to receive a CDDPBC cycle were invited to participate', 'Children\u2009≥', 'pediatric patients receiving', 'children with solid tumors treated with', 'pediatric patients with solid tumors treated with CDDPBC']","['magnesium', 'cisplatin-based chemotherapy', 'cisplatin-based chemotherapy (CDDPBC', 'oral magnesium supplementation', 'magnesium supplementation (control group', 'Oral magnesium supplementation']","['FN episodes', 'FN episodes neutropenia', 'Efficacy and safety', 'Efficacy', 'episodes of septic shock secondary to FN', 'Hypomagnesemia episodes and adverse events', 'febrile neutropenia episodes']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.387148,"Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32-0.89), NNT = 4].","[{'ForeName': 'Osvaldo D', 'Initials': 'OD', 'LastName': 'Castelán-Martínez', 'Affiliation': 'Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, UNAM, Batalla 5 de mayo s/n esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, CP 09230, Mexico City, Mexico. castelan@unam.mx.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Palomo-Colli', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Barrios-López', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Karla M', 'Initials': 'KM', 'LastName': 'Silva-Jivaja', 'Affiliation': 'Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, UNAM, Batalla 5 de mayo s/n esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, CP 09230, Mexico City, Mexico.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Juárez-Villegas', 'Affiliation': 'Onco-Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Castañeda-Hernández', 'Affiliation': 'Pharmacology Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': 'Research Uniton Gerontology, Facultad de Estudios Superiores Zaragoza, UNAM, Mexico City, Mexico.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04155-4']
2827,33026752,Efficacy and Safety of Intense Pulsed Light With a KTP/PDLlike Filter for the Treatment of Facial Telangiectasias.,"BACKGROUND


An intense pulsed light (IPL) narrowband ""KTP/PDL-like"" filter (525&ndash;585 nm) may combine the tolerability of the IPL with the precision of KTP and PDL lasers. This study evaluated the impact of IPL with a KTP/PDL-like filter on telangiectasias.
METHODS


This was a single-center, prospective study of 17 subjects with facial telangiectasias and skin types I&ndash;III. Three monthly treatments were performed using this specific filter, with follow-up visits at 1, 3, and 6 months. Telangiectasia improvement was assessed by the investigator and subjects using a 5-point scale. Facial photographs and safety assessments were obtained at each visit. Subject discomfort was evaluated using a visual analog scale (VAS) immediately posttreatment, and subject downtime was recorded at each subsequent visit.
RESULTS


All facial telangiectasias significantly improved. At 1-month follow-up, &gt;50% lesion clearance was noted in 97.1% of facial (n=36) and 85.7% of non-facial (n=7) lesions, with 73% of subjects satisfied or very satisfied. An increase in mean social downtime (0, 2.3, and 3 days) and VAS scores (3.5, 4.5, and 4.8) with treatments 1, 2, and 3, respectively, mirrored a stepwise increase in fluence with subsequent sessions.
CONCLUSIONS


The use of a novel IPL narrowband KTP/PDL-like filter can significantly improve facial and non-facial telangiectasias with minimal downtime. J Drugs Dermatol. 2020;19(9):844-850. doi:10.36849/JDD.2020.4834.",2020,"An increase in mean social downtime (0, 2.3, and 3 days) and VAS scores (3.5, 4.5, and 4.8) with treatments 1, 2, and 3, respectively, mirrored a stepwise increase in fluence with subsequent sessions.
",['17 subjects with facial telangiectasias and skin types I&ndash;III'],"['KTP/PDLlike Filter', 'KTP/PDL-like filter', 'novel IPL narrowband KTP/PDL-like filter', 'Intense Pulsed Light', 'pulsed light (IPL) narrowband ""KTP/PDL-like"" filter (525&ndash;585 nm']","['lesion clearance', 'VAS scores', 'Efficacy and Safety', 'Telangiectasia improvement', 'mean social downtime', 'Facial photographs and safety assessments', 'visual analog scale (VAS) immediately posttreatment, and subject downtime']","[{'cui': 'C0858684', 'cui_str': 'Telangiectasis facial'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",17.0,0.0231064,"An increase in mean social downtime (0, 2.3, and 3 days) and VAS scores (3.5, 4.5, and 4.8) with treatments 1, 2, and 3, respectively, mirrored a stepwise increase in fluence with subsequent sessions.
","[{'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Friedmann', 'Affiliation': ''}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Abdo', 'Affiliation': ''}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Cahana', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.4834']
2828,33026753,"Safety, Pharmacokinetics, and Efficacy of Efinaconazole 10% Topical Solution for Onychomycosis Treatment in Pediatric Patients.","BACKGROUND


Pediatric onychomycosis management is challenging as there are limited treatment options. The objective of this study was to evaluate efinaconazole 10% topical solution in children with onychomycosis.
METHODS


This phase 4, multicenter, open-label study (NCT02812771) evaluated safety, pharmacokinetics (PK), and efficacy of efinaconazole 10% topical solution in pediatric participants (6-16 years). Efinaconazole was administered once daily for 48 weeks, with a 4-week posttreatment follow up. Participants had culture-positive, mild-to-severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail. The PK subset included participants 12-16 years with moderate-to-severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails.
RESULTS


Of 62 enrolled participants, 60 were included in the safety population and 17 in the PK population. Efinaconazole 10% topical solution was well tolerated. The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval. Systemic exposure to efinaconazole was low. By week 52, 65.0% of participants achieved mycologic cure, with a 36.7% mycologic cure rate observed as early as week 12. A total of 40.0% of participants achieved complete cure, 50.0% achieved clinical efficacy, and 88.3% achieved fungal cure by week 52.
CONCLUSION


Efinaconazole was safe and efficacious in pediatric participants with mild-to-severe onychomycosis, with improved mycologic cure and complete cure rates compared with adults from two 52-week studies. J Drugs Dermatol. 2020;19(9):867-872. doi:10.36849/JDD.2020.5401.",2020,"The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval.","['pediatric participants (6-16 years', 'children with onychomycosis', 'Participants had culture-positive, mild-to-severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail', 'Pediatric Patients', '62 enrolled participants', ' 60 were included in the safety population and 17 in the PK population', 'pediatric participants with mild-to-severe onychomycosis', 'participants 12-16 years with moderate-to-severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails']","['Efinaconazole 10% topical solution', 'Efinaconazole 10% Topical Solution', 'Efinaconazole', 'efinaconazole 10% topical solution']","['mycologic cure', 'mycologic cure and complete cure rates', 'clinical efficacy', 'Safety, Pharmacokinetics, and Efficacy', 'safety, pharmacokinetics (PK), and efficacy', 'tolerated', 'concentration-time profiles', 'complete cure', 'mycologic cure rate', 'fungal cure']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3832835', 'cui_str': 'Efinaconazole 100 mg/mL cutaneous solution'}, {'cui': 'C3273754', 'cui_str': 'efinaconazole'}]","[{'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521033', 'cui_str': 'fungi'}]",62.0,0.11571,"The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval.","[{'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ''}, {'ForeName': 'Boni', 'Initials': 'B', 'LastName': 'Elewski', 'Affiliation': ''}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Sugarman', 'Affiliation': ''}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Tracey C', 'Initials': 'TC', 'LastName': 'Vlahovic', 'Affiliation': ''}, {'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': ''}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5401']
2829,33026755,"Randomized, Double-Blinded, Split-Face Study Comparing the Efficacy and Tolerability of Two Topical Products for Melasma.","BACKGROUND


Melasma is a common disorder of hyperpigmentation that disproportionately affects individuals with skin of color. There is a paucity of studies evaluating non-hydroquinone (HQ) topical therapies for the treatment of melasma in darker skin types.
OBJECTIVE


To compare the safety, efficacy, and tolerability of a HQ-free, retinol-free cosmetic topical brightener (CTB) and HQ 4% in the treatment of moderate symmetric facial melasma in patients with Fitzpatrick skin types (FST) III&ndash;VI. Methods &amp; Materials: This was a randomized, double-blinded, split-face clinical trial. Eighteen adult patients with facial melasma were treated with CTB and HQ 4%, each to a different side of the face, twice daily for 12 weeks. Clinical assessments included half-face Melasma Area Severity Index (MASI), Overall Hyperpigmentation scale, and Melasma Severity Rating Scale (MSRS). Patients completed a Melasma Quality of Life (MelasQoL) questionnaire and clinical photographs were taken at each visit.
RESULTS


CTB and HQ 4% demonstrated statistically significant improvements in half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol compared to baseline. HQ 4% showed statistically significant improvements in MSRS at week 12 compared to CTB, but was non-superior for all other clinical endpoints.
CONCLUSION


HQ-free, retinol-free CTB and HQ 4% both are effective and well-tolerated in the treatment of moderate facial melasma in FST III&ndash;VI. J Drugs Dermatol. 2020;19(9):822-827. doi:10.36849/JDD.2020.5353.",2020,"4% demonstrated statistically significant improvements in half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol compared to baseline.","['Melasma', 'moderate symmetric facial melasma in patients with Fitzpatrick skin types (FST) III&ndash;VI', 'Eighteen adult patients with facial melasma']","['CTB and HQ', 'hydroquinone (HQ) topical therapies', 'HQ', 'HQ-free, retinol-free cosmetic topical brightener (CTB']","['safety, efficacy, and tolerability', 'half-face Melasma Area Severity Index (MASI), Overall Hyperpigmentation scale, and Melasma Severity Rating Scale (MSRS', 'Efficacy and Tolerability', 'MSRS', 'Melasma Quality of Life (MelasQoL) questionnaire and clinical photographs', 'half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C3214478', 'cui_str': 'Hydroquinone-containing product in cutaneous dose form'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",18.0,0.151615,"4% demonstrated statistically significant improvements in half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol compared to baseline.","[{'ForeName': 'Bridget P', 'Initials': 'BP', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Alexis', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5353']
2830,33026766,"Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results.","BACKGROUND


No FDA-approved prescription therapies are available for common warts.
OBJECTIVE


We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts.
METHODS


In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged &ge;8 years had 1&ndash;6 warts (1 target wart) on the trunk or extremities with a Physician&rsquo;s Wart Assessment&trade; (PWA) grade &ge;2 (range, 0 [clear] to 3 [wart 3&ndash;8 mm in diameter or length]). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).
RESULTS


A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (&minus;0.87) vs vehicle (&minus;0.17; P&lt;0.0001) and maintained at week 20 (&minus;1.00 vs &minus;0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P&lt;0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76 TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (&minus;1.0 vs 0) and 20 (&minus;1.2 vs &minus;0.5).
CONCLUSION


These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.",2020,These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age.,"['eligible patients aged &ge;8 years had 1&ndash;6 warts (1 target wart) on the trunk or extremities with a Physician&rsquo;s Wart Assessment&trade', '157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76', 'common warts in patients &ge;8 years of age']","['Hydrogen Peroxide Topical Solution', 'hydrogen peroxide topical solution, 45% (w/w) (HP45']","['proportion of patients with target wart clearance', 'Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs', 'mild or moderate in severity', 'efficacy and safety of HP45', 'mean target wart PWA grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1246476', 'cui_str': 'Hydrogen Peroxide Topical Solution'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",157.0,0.315755,These findings support the efficacy and safety of HP45 for the treatment of common warts in patients &ge;8 years of age.,"[{'ForeName': 'Stacy R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Trying', 'Affiliation': ''}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Grande', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': ''}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Shanier', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5054']
2831,33026771,IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.,"BACKGROUND


Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin&reg;, Bocouture&reg;; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here.
METHODS


151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale.
RESULTS


The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]).
CONCLUSIONS


These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985-991. doi:10.36849/JDD.2020.5454.",2020,Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups.,"['151 subjects with moderate-to-severe GFL', 'Glabellar Lines']","['botulinum toxin', 'IncobotulinumtoxinA (INCO', 'IncobotulinumtoxinA']","['incidence of treatment-related adverse events', 'Duration of effect', 'duration of efficacy', 'median duration of effect', 'tolerated and safety', 'median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0948887', 'cui_str': 'Glabellar frown lines'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",151.0,0.100046,Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': ''}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Fabi', 'Affiliation': ''}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Welf', 'Initials': 'W', 'LastName': 'Prager', 'Affiliation': ''}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Rzany', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': ''}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': ''}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Maas', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5454']
2832,33026823,Repetitive Antegrade Contractions: A novel response to sustained esophageal distension is modulated by cholinergic influence.,"BACKGROUND & AIMS


A unique motor response to sustained esophageal distension, repetitive antegrade contractions (RACs), is observed using functional luminal imaging probe (FLIP) panometry. However, physiologic mechanisms related to this response are unexplored. This study aimed to evaluate the impact of cholinergic inhibition with atropine on the esophageal contractile response to sustained distention, including RACs, among healthy volunteers.
METHODS


8 asymptomatic volunteers (ages 22-45) were evaluated in a crossover study design with 16-cm FLIP positioned across the esophagogastric junction and distal esophagus during sedated upper endoscopy. The FLIP study involving stepwise volumetric distension was performed twice in each subject, at baseline and again after atropine (15 mcg/kg) was administered intravenously. FLIP panometry was analyzed to assess the contractile response to distension.
RESULTS


Antegrade contractions, lumen-occluding contractions, and a RAC pattern were observed in 8/8, 8/8, and 7/8(88%) subjects, respectively, at baseline and in 5/8 (63%), 2/8 (25%) and 2/8 (25%) subjects after atropine. The rate of contractions in the RAC pattern was similar (6-7 contractions per minute) before and after atropine. Compared with the baseline study, distension-induced contractility was triggered at higher fill volumes after atropine. FLIP pressures were lower in response to volumetric filling after atropine than at baseline.
CONCLUSIONS


The vigor and triggering of the esophageal contractile response to distension is reduced by cholinergic inhibition in asymptomatic controls. The observation that the rate of contractions did not change when patients developed repetitive contractile responses suggests that this rate is not modified by cholinergic inhibition once contractility is triggered.",2020,The rate of contractions in the RAC pattern was similar (6-7 contractions per minute) before and after atropine.,"['8 asymptomatic volunteers (ages 22-45', 'healthy volunteers']","['repetitive antegrade contractions (RACs', 'atropine', 'Repetitive Antegrade Contractions']","['contractile response to distension', 'FLIP pressures', 'Antegrade contractions, lumen-occluding contractions, and a RAC pattern', 'distension-induced contractility', 'rate of contractions in the RAC pattern']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0668624', 'cui_str': 'AKT1 protein, human'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",8.0,0.0869158,The rate of contractions in the RAC pattern was similar (6-7 contractions per minute) before and after atropine.,"[{'ForeName': 'Dustin A', 'Initials': 'DA', 'LastName': 'Carlson', 'Affiliation': 'Medicine, Northwestern University, United States.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Kou', 'Affiliation': 'Medicine, Northwestern University, United States.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Masihi', 'Affiliation': 'Medicine, Northwestern University, United States.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Mechanical Engineering, Northwestern University, United States.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Baumann', 'Affiliation': 'Medicine, Northwestern University, United States.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Donnan', 'Affiliation': 'Medicine, Northwestern Univerisity, United States.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kahrilas', 'Affiliation': 'Northwestern University.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pandolfino', 'Affiliation': 'Gastroenterology, Northwestern University, United States.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00305.2020']
2833,33026876,Promoting ear plugs at music events: evaluation of the Celebrate Safe approach.,"OBJECTIVE


The Celebrate Safe approach is a collaboration between public health organisations and music event/venue organisers to encourage health promotion interventions in nightlife settings and at music events. The purpose of this study was to evaluate the Celebrate Safe approach with regard to its impact on use of ear plugs among visitors of music events.
DESIGN


A pre-registered cluster-randomised controlled trial conducted at music events throughout the Netherlands ( k  = 15). In the experimental condition, event organisers were asked to share an online pre-event message about ear plugs, clearly indicate where visitors could buy ear plugs, and sell ear plugs at busy locations on the premises. Visitors were encouraged to wear ear plugs by means of an 'ear check' at the beginning of the event.  Study sample  : Observations to assess whether event visitors wear ear plugs ( N  = 3836).
RESULTS


A multilevel model, taking into account nesting of visitors within events, revealed that use of ear plugs at music events in the experimental condition was higher in comparison to events in the control condition (23% vs. 14%, OR = 1.9, 95%CI 1.2-3.0,  p  = 0.004).
CONCLUSIONS


The Celebrate Safe approach has a positive impact on use of ear plugs among visitors of music events.",2020,"A multilevel model, taking into account nesting of visitors within events, revealed that use of ear plugs at music events in the experimental condition was higher in comparison to events in the control condition (23% vs. 14%, OR = 1.9, 95%CI 1.2-3.0,  p  = 0.004).
",['Study sample  '],[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],[],,0.0447,"A multilevel model, taking into account nesting of visitors within events, revealed that use of ear plugs at music events in the experimental condition was higher in comparison to events in the control condition (23% vs. 14%, OR = 1.9, 95%CI 1.2-3.0,  p  = 0.004).
","[{'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, Maastricht University/CAPHRI, Maastricht, Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Noijen', 'Affiliation': 'Jellinek Preventie, Arkin, Amsterdam, Netherlands.'}, {'ForeName': 'Gjalt-Jorn Ygram', 'Initials': 'GY', 'LastName': 'Peters', 'Affiliation': 'Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}]",International journal of audiology,['10.1080/14992027.2020.1828630']
2834,33026895,Action observation training and brain-computer interface controlled functional electrical stimulation enhance upper extremity performance and cortical activation in patients with stroke: a randomized controlled trial.,"PURPOSE


Brain-computer interface (BCI)-functional electronic stimulation (FES) systems are increasingly being explored as potential neuro-rehabilitation tools. Here, we investigate the effect of action observation training (AOT) plus electroencephalogram (EEG)-based BCI-controlled FES system on motor recovery of upper extremity and cortical activation in patients with stroke.
METHOD


There were a total of 26 patients: an AOT plus BCI-FES group (n = 13) and a control group (n = 13). The control group performed FES treatment and the conventional physical therapy, while the AOT plus BCI-FES group performed AOT plus BCI-FES and the conventional physical therapy. Upper extremity performance was measured using the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL) and Modified Barthel Index (MBI). Cortical activation was measured using electro-encephalographic recordings from alpha and beta power, concentration, and activation.
RESULTS


After intervention, there were significant differences between two groups in FMA-UE, WMFT, MAL and MBI and the results of EEG including alpha power, beta power, concentration and activation.
CONCLUSIONS


This study demonstrated that AOT plus BCI-FES can enhance motor function of upper extremity and cortical activation in patients with stroke. This training method may be feasible and suitable for individuals with stroke.",2020,"After intervention, there were significant differences between two groups in FMA-UE, WMFT, MAL and MBI and the results of EEG including alpha power, beta power, concentration and activation.
","['individuals with stroke', 'patients with stroke']","['Action observation training and brain-computer interface controlled functional electrical stimulation', 'action observation training (AOT) plus electroencephalogram (EEG)-based BCI-controlled FES system', 'AOT plus BCI-FES', 'conventional physical therapy, while the AOT plus BCI-FES group performed AOT plus BCI-FES and the conventional physical therapy', 'Brain-computer interface (BCI)-functional electronic stimulation (FES) systems']","['Cortical activation', 'Upper extremity performance', 'FMA-UE, WMFT, MAL and MBI and the results of EEG including alpha power, beta power, concentration and activation', 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL) and Modified Barthel Index (MBI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",26.0,0.0155119,"After intervention, there were significant differences between two groups in FMA-UE, WMFT, MAL and MBI and the results of EEG including alpha power, beta power, concentration and activation.
","[{'ForeName': 'Su-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University , Seoul, Korea.'}, {'ForeName': 'Seong Sik', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Sahmyook University , Seoul, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University , Seoul, Korea.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1831114']
2835,33026938,Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer.,"PURPOSE


Patients with advanced esophageal cancer have a poor prognosis and limited treatment options after first-line chemotherapy.
PATIENTS AND METHODS


In this open-label, phase III study, we randomly assigned (1:1) 628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to pembrolizumab 200 mg every 3 weeks for up to 2 years or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan). Primary end points were overall survival (OS) in patients with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 10, in patients with squamous cell carcinoma, and in all patients (one-sided α 0.9%, 0.8%, and 0.8%, respectively).
RESULTS


At final analysis, conducted 16 months after the last patient was randomly assigned, OS was prolonged with pembrolizumab versus chemotherapy for patients with CPS ≥ 10 (median, 9.3  v  6.7 months; hazard ratio [HR], 0.69 [95% CI, 0.52 to 0.93];  P  = .0074). Estimated 12-month OS rate was 43% (95% CI, 33.5% to 52.1%) with pembrolizumab versus 20% (95% CI, 13.5% to 28.3%) with chemotherapy. Median OS was 8.2 months versus 7.1 months (HR, 0.78 [95% CI, 0.63 to 0.96];  P  = .0095) in patients with squamous cell carcinoma and 7.1 months versus 7.1 months (HR, 0.89 [95% CI, 0.75 to 1.05];  P  = .0560) in all patients. Grade 3-5 treatment-related adverse events occurred in 18.2% of patients with pembrolizumab versus 40.9% in those who underwent chemotherapy.
CONCLUSION


Pembrolizumab prolonged OS versus chemotherapy as second-line therapy for advanced esophageal cancer in patients with PD-L1 CPS ≥ 10, with fewer treatment-related adverse events.",2020,"Median OS was 8.2 months versus 7.1 months (HR, 0.78","['Patients with advanced esophageal cancer', '628 patients with advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, that progressed after one prior therapy, to', 'Advanced Esophageal Cancer']","['Pembrolizumab Versus Chemotherapy', 'pembrolizumab', 'Pembrolizumab prolonged OS versus chemotherapy', 'pembrolizumab versus chemotherapy', ""pembrolizumab 200 mg every 3 weeks for up to 2 years or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan""]","['Median OS', 'overall survival (OS', 'adverse events', 'Estimated 12-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma of esophagus'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",628.0,0.110357,"Median OS was 8.2 months versus 7.1 months (HR, 0.78","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kojima', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Manish A', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Francois', 'Affiliation': 'CLCC Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'IRCM, Inserm, Université Montpellier, ICM, Montpellier, France.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Doi', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Japan.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancerologie de L'Ouest, Nantes, France.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Enzinger', 'Affiliation': 'Dana Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Shu-Kui', 'Initials': 'SK', 'LastName': 'Qin', 'Affiliation': 'PLA Cancer Centre of Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ferreira', 'Affiliation': 'Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E., Porto, Portugal.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Cancer Hospital, Nanging, China.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Girotto', 'Affiliation': 'Hospital de Base de Sao Jose do Rio Preto, Sao Jose do Rio Preto, Brazil.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': 'Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Senellart', 'Affiliation': 'Centre Rene Gauducheau ICO, Saint Herblain, France.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Al-Rajabi', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Shailaja', 'Initials': 'S', 'LastName': 'Suryawanshi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bhagia', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Kang', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': ""CHU Brest - Institut de Cancerologie et d'Hematologie, Arpego Network, Brest, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01888']
2836,33027167,Predictors of Long-Term Pain After Hip Arthroplasty in Patients With Femoral Neck Fractures: A Cohort Study.,"OBJECTIVES


To identify factors associated with the development of prolonged pain after hip fracture surgery.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Eighty hospitals in 10 countries.
PATIENTS/PARTICIPANTS


One thousand four hundred forty-one hip fracture patients in the HEALTH trial.
INTERVENTIONS


Total hip arthroplasty or hemiarthroplasty.
MAIN OUTCOME MEASURES


Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty.
RESULTS


Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%).
CONCLUSIONS


Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%).","['Eighty hospitals in 10 countries', 'One thousand four hundred forty-one hip fracture patients in the HEALTH trial', 'hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery', 'Patients With Femoral Neck Fractures', 'Total hip arthroplasty or hemiarthroplasty']",['Hip Arthroplasty'],"['Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale', 'prefacture functional status', 'risk of persistent pain', 'Predictors of Long-Term Pain', 'moderate-to-severe pain', 'prefracture opioid use', 'risk of pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0186193', 'cui_str': 'Repair of hip'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",1441.0,0.388196,"Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Noori', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Busse', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001929']
2837,33027168,Who Did the Arthroplasty? Hip Fracture Surgery Reoperation Rates are Not Affected by Type of Training-An Analysis of the HEALTH Database.,"OBJECTIVES


This study compares outcomes for patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training.
DESIGN


Retrospective review of HEALTH trial data.
SETTING


Eighty clinical sites across 10 countries.
PATIENTS/PARTICIPANTS


One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention.
INTERVENTION


Patients were randomized to either HA or THA groups in the initial data set. Surgeons' fellowship training was ascertained retrospectively, and outcomes were compared.
MAIN OUTCOME MEASUREMENTS


The main outcome was an unplanned secondary procedure at 24 months. Secondary outcomes included death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively.
RESULTS


There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon. There were significantly higher odds of being discharged to a facility rather than home in patients who underwent surgery by a surgeon with no fellowship training compared with arthroplasty-fellowship-trained surgeons (P = 0.03).
CONCLUSIONS


Arthroplasty for hip fracture can be performed by all orthopaedic surgeons with equivalent reoperation rates. Infection prevention strategies and use of ""care pathways"" by arthroplasty-fellowship-trained surgeons may account for the lower risk of PJI and higher rate of discharge to home. The authors advocate for the use of evidence-based infection prevention initiatives and standardized care pathways in this patient population.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon.","['Eighty clinical sites across 10 countries', 'patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training', 'One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention']",['HA or THA'],"['Hip Fracture Surgery Reoperation Rates', 'death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively', 'risk of PJI']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1441.0,0.27038,"There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'DeAngelis', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Minutillo', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Stein', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Donegan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001931']
2838,33027214,Acute Ketogenic Diet and Ketone Ester Supplementation Impairs Race Walk Performance.,"Consumption of a ketogenic low-carbohydrate (CHO), high-fat (LCHF) diet increases skeletal muscle fat utilization but impairs exercise economy. Whether the concomitant increase in circulating endogenous ketone bodies (KB) alters the capacity to metabolize exogenous ketone supplements such as the popular ketone monoester (KE) is unknown.
PURPOSE


To determine if LCHF and KE supplementation can synergistically alter exercise metabolism and improve performance.
METHODS


Elite race walkers (n=18, 15 male, 3 female; V[Combining Dot Above]O2peak 62 ± 6 mL·min·kg) undertook a 4-stage exercise economy test and real-life 10,000 m race prior to and following a 5-d isoenergetic high CHO (HCHO; ~60-65% CHO, 20% fat; n=9) or LCHF (75-80% fat, <50 g/day CHO, n=9) diet. The LCHF group performed additional economy tests pre/post diet after supplementation with 573 mg·kg body mass KE (HVMN, HVMN Inc.), which was also consumed for Race 2.
RESULTS


The oxygen cost of exercise (relative V[Combining Dot Above]O2, mL·min·kg) increased across all 4 stages following LCHF (p<0.005). This occurred in association with increased fat oxidation rates, with a reciprocal decrease in CHO oxidation (p<0.001). Substrate utilisation in the HCHO group remained unaltered. Consumption of KE prior to the LCHF diet increased circulating KB (p<0.05), peaking at 3.2 ± 0.6 mM but did not alter V[Combining Dot Above]O2 or RER. LCHF diet elevated resting circulating KB (0.3 ± 0.1 vs. 0.1 ± 0.1 mM), but concentrations following supplementation did not differ from the earlier ketone trial. Critically, race performance was impaired by ~6% (p<0.0001) relative to baseline in the LCHF group but was unaltered in HCHO.
CONCLUSION


Despite elevating endogenous KB production, a LCHF diet does not augment the metabolic responses to KE supplementation, and negatively impacts race performance.",2020,"Critically, race performance was impaired by ~6% (p<0.0001) relative to baseline in the LCHF group but was unaltered in HCHO.
","['Elite race walkers ', 'n=18, 15 male, 3 female']","['ketogenic low-carbohydrate (CHO), high-fat (LCHF) diet', 'V[Combining', 'LCHF', 'LCHF and KE supplementation', 'Acute Ketogenic Diet and Ketone Ester Supplementation']","['Substrate utilisation', 'V[Combining Dot Above]O2 or RER', 'race performance', 'circulating KB', 'oxygen cost of exercise (relative V[Combining', 'Race Walk Performance', 'fat oxidation rates', 'CHO oxidation', 'exercise metabolism and improve performance', 'endogenous KB production', 'Dot Above]O2, mL·min·kg']","[{'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}]",,0.0320921,"Critically, race performance was impaired by ~6% (p<0.0001) relative to baseline in the LCHF group but was unaltered in HCHO.
","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Whitfield', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Burke', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Alannah K A', 'Initials': 'AKA', 'LastName': 'McKay', 'Affiliation': 'Australian Institute of Sport, Canberra, ACT, Australia.'}, {'ForeName': 'Ida A', 'Initials': 'IA', 'LastName': 'Heikura', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Fensham', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Avish P', 'Initials': 'AP', 'LastName': 'Sharma', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002517']
2839,33027217,Comprehensive Respiratory Muscle Training Improves Pulmonary Function and Respiratory Muscle Strength in Acute Stroke Patients.,"PURPOSE


To evaluate the effects of respiratory muscle training (RMT) on pulmonary function, respiratory complications, and stroke-related disabilities in patients with acute stroke.
METHODS


One hundred twenty-two subjects with stroke admitted to the stroke rehabilitation center of Inje Hospital between August 2016 and May 2018 were recruited. After the initial exclusion, the remaining patients were assigned to the RMT group (36 patients) or the standard rehabilitation (SR) group (28 patients who did not undergo RMT). A total of 44 patients completed the study, with 22 patients in each group. The RMT program consisted of air-stacking exercise, manually assisted coughing, inspiratory and expiratory muscle strengthening, cough exercises, and respiratory reeducation. Pulmonary function and respiratory muscle strength were evaluated before commencement and after 1 mo of RMT. The Functional Ambulation Category score, Korean version of the Modified Barthel Index, Shoulder Abduction and Finger Extension score, and handgrip power were assessed. The incidence of pneumonia was also evaluated.
RESULTS


Both pulmonary function and respiratory muscle strength significantly improved in both groups. However, differences (%) in the RMT group was greater for all parameters of pulmonary function and respiratory muscle strength. Respiratory complications at 1 yr were significantly lower in the RMT group (P = .016).
CONCLUSION


Four weeks of comprehensive RMT in patients with acute stroke resulted in significantly greater improvements in both pulmonary function and respiratory muscle strength than SR. Therefore, RMT has the potential to reduce post-stroke respiratory complications.",2020,"However, differences (%) in the RMT group was greater for all parameters of pulmonary function and respiratory muscle strength.","['44 patients completed the study, with 22 patients in each group', 'Acute Stroke Patients', 'group (28 patients who did not undergo RMT', 'One hundred twenty-two subjects with stroke admitted to the stroke rehabilitation center of Inje Hospital between August 2016 and May 2018 were recruited', 'patients with acute stroke']","['standard rehabilitation (SR', 'RMT', 'Comprehensive Respiratory Muscle Training', 'air-stacking exercise, manually assisted coughing, inspiratory and expiratory muscle strengthening, cough exercises, and respiratory reeducation', 'respiratory muscle training (RMT']","['pulmonary function, respiratory complications, and stroke-related disabilities', 'incidence of pneumonia', 'Functional Ambulation Category score, Korean version of the Modified Barthel Index, Shoulder Abduction and Finger Extension score, and handgrip power', 'Pulmonary function and respiratory muscle strength', 'Respiratory complications', 'pulmonary function and respiratory muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0586750', 'cui_str': 'Cough on exercise'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",122.0,0.0270845,"However, differences (%) in the RMT group was greater for all parameters of pulmonary function and respiratory muscle strength.","[{'ForeName': 'Hee Eun', 'Initials': 'HE', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Geun Yeol', 'Initials': 'GY', 'LastName': 'Jo', 'Affiliation': ''}, {'ForeName': 'Hwan Kwon', 'Initials': 'HK', 'LastName': 'Do', 'Affiliation': ''}, {'ForeName': 'Cheol Won', 'Initials': 'CW', 'LastName': 'On', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000526']
2840,33027229,Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial.,,2020,,['patients with pneumonia'],['Mechanical insufflation/exsufflation compared with standard of care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.236647,,"[{'ForeName': 'Fredrikke C', 'Initials': 'FC', 'LastName': 'Knudtzen', 'Affiliation': 'From the Department of Infectious Diseases, Odense University Hospital, Denmark (FCK, ISJ), Respiratory Centre South, Odense University Hospital, Denmark (MS), Division of Infection, Immunity and Respiratory Medicine, University of Manchester, and North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK (JV).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sprehn', 'Affiliation': ''}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': ''}, {'ForeName': 'Isik S', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001209']
2841,33027246,The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.,"BACKGROUND


Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.
METHODS AND FINDINGS


We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention.
CONCLUSIONS


We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov under registration number NCT02626351.",2020,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","['primary care clinics in rural South Africa', '7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months', 'All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment', 'rural South Africa', 'Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis', 'rural African communities']","['CQI to usual standard of antenatal care (ANC', 'CQI', 'trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions']","['coverage of antenatal HIV care tests', 'adverse events', 'quality of antenatal HIV care', 'repeat HIV testing', 'HIV prevalence', 'VL monitoring', 'viral load (VL) monitoring']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",2160.0,0.110171,"In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958).","[{'ForeName': 'H Manisha', 'Initials': 'HM', 'LastName': 'Yapa', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Jan-Walter', 'Initials': 'JW', 'LastName': 'De Neve', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Terusha', 'Initials': 'T', 'LastName': 'Chetty', 'Affiliation': 'Health systems Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Post', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Awachana', 'Initials': 'A', 'LastName': 'Jiamsakul', 'Affiliation': 'The Kirby Institute, University of New South Wales Sydney, NSW, Australia.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Harling', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dhlomo-Mphatswe', 'Affiliation': 'School of Clinical Medicine, Discipline of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Mosa', 'Initials': 'M', 'LastName': 'Moshabela', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Ogbuoji', 'Affiliation': 'Global Health Institute, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Dickman', 'Initials': 'D', 'LastName': 'Gareta', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Kobus', 'Initials': 'K', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003150']
2842,33027267,The role of health education on cervical cancer screening uptake at selected health centers in Addis Ababa.,"INTRODUCTION


Cervical cancer is one of the most common causes of morbidity and mortality among women in developing countries including Ethiopia. Unlike other types of cancers, the grave outcomes of cervical cancer could be prevented if detected at its early stage. However, in Ethiopia, awareness about the disease and the availability of screening and treatment services is limited. This study aims to determine the role of health education on cervical cancer screening uptake in selected health facilities in Addis Ababa.
METHODS


Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia. Each of the eight health centers were randomly assigned to serve as either an intervention or a control center. A two-pronged clustered randomized controlled trial was conducted in eight public health care centers. All the selected facilities provided cervical cancer screening services using visual inspection with acetic acid (VIA). Four health centers were randomly assigned to the intervention and control arms. The study participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer. In the intervention health centers, all eligible women received one-to-one health education and educational brochures about cervical cancer and cervical cancer screening. In the control health centers, participants received standard care. Baseline data were collected at recruitment and follow-up data were collected two months after the baseline. For the follow-up data collection, participants (both in the intervention and control arms) were interviewed over the phone to check whether they were screened for cervical cancer.
RESULT


From the 2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers. Seventy-four percent of these participants reported that they learned about the benefits of screening from the one-to-one health education or the brochure. Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls. Women with the educational status of the first degree and those who have a history of sexually transmitted infections (STIs) had higher odds of getting screened (AOR = 2.03,95%CI;(1.15-2.58) and (AOR = 1.55,95%CI;1.01-2.36), respectively.
CONCLUSION AND RECOMMENDATION


Providing focused health education supported by printed educational materials increased the uptake of cervical cancer screening services. Integrating one-to-one health education and providing a take-home educational material into the existing maternal and child health services can help increase cervical cancer screening uptake.",2020,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","['Four health centers', 'women in developing countries including Ethiopia', 'participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer', 'eight public health care centers', '2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers', 'cervical cancer screening uptake at selected health centers in Addis Ababa', 'eight health centers', 'Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia', 'selected health facilities in Addis Ababa']","['health education', 'one-to-one health education and educational brochures about cervical cancer and cervical cancer screening', 'visual inspection with acetic acid (VIA']",[],"[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}]",[],2140.0,0.136285,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","[{'ForeName': 'Selamawit Hirpa', 'Initials': 'SH', 'LastName': 'Abu', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Berhan Tassew', 'Initials': 'BT', 'LastName': 'Woldehanna', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Etsehiwot Tilahun', 'Initials': 'ET', 'LastName': 'Nida', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Abigiya Wondimagegnehu', 'Initials': 'AW', 'LastName': 'Tilahun', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mahlet Yigeremu', 'Initials': 'MY', 'LastName': 'Gebremariam', 'Affiliation': 'School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mitike Molla', 'Initials': 'MM', 'LastName': 'Sisay', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0239580']
2843,33027362,Antibiotic prophylaxis in breast cancer surgery. A randomized controlled trial.,"PURPOSE


To assess the effect of antibiotic prophylaxis on surgical site infection (SSI) rates in women undergoing breast cancer surgery in two tertiary hospitals in Brazil.
METHODS


This was a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 124 women without independent risk factors for SSI were randomly assigned to receive either cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis. After surgery, all surgical wounds were examined once a week, for four weeks, according to the Centers for Disease Control and Prevention definitions and classifications for SSI.
RESULTS


Baseline characteristics were homogeneous between the two groups. Only one patient in the antibiotic group developed SSI, which was classified as superficial incisional. The overall SSI rate was low, with no significant difference between groups.
CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.",2020,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","['women undergoing breast cancer surgery in two tertiary hospitals in Brazil', '124 women without independent risk factors for SSI', 'breast cancer surgery']","['antibiotic prophylaxis', 'placebo', 'cefazolin (antibiotic group, n = 62) or placebo (control group, n = 62) as preoperative prophylaxis', 'Antibiotic prophylaxis']","['surgical site infection (SSI) rates', 'overall SSI rate', 'SSI rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",124.0,0.590906,"CONCLUSION


Antibiotic prophylaxis had no significant effect on reducing SSI rates in women without independent risk factors for SSI undergoing breast cancer surgery.","[{'ForeName': 'Rubens Murilo de Athayde', 'Initials': 'RMA', 'LastName': 'Prudencio', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, Universidade do Vale do Sapucaí (UNIVÁS), Pouso Alegre-MG, and Breast Cancer Unit, Hospital São Cristóvão, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Fabíola Soares Moreira', 'Initials': 'FSM', 'LastName': 'Campos', 'Affiliation': ""Master, Professional Master's Program in Applied Health Sciences, and Hospital das Clínicas Samuel Libânio, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition, interpretation and analysis of data; manuscript writing; final approval.""}, {'ForeName': 'Ana Beatriz Alkmim Teixeira', 'Initials': 'ABAT', 'LastName': 'Loyola', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}, {'ForeName': 'Ivanildo', 'Initials': 'I', 'LastName': 'Archangelo Junior', 'Affiliation': 'MD, Department of Breast Surgery, UNIVÁS, Pouso Alegre-MG, Brazil. Conception, design, intellectual and scientific content of the study; acquisition of data; final approval.'}, {'ForeName': 'Neil Ferreira', 'Initials': 'NF', 'LastName': 'Novo', 'Affiliation': 'PhD, Full Professor, Department of Biostatistics, UNIVÁS, Pouso Alegre-MG, Brazil. Interpretation of data, statistical analysis, critical revision, final approval.'}, {'ForeName': 'Lydia Masako', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': 'PhD, Chairwoman, Head, Postgraduate Program in Translational Surgery, Division of Plastic Surgery, Universidade Federal de São Paulo (UNIFESP), Sao Paulo-SP, Brazil. Critical revision, final approval.'}, {'ForeName': 'Daniela Francescato', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': ""PhD, Associate Professor, Professional Master's Program in Applied Health Sciences, UNIVÁS, Pouso Alegre-MG, and Postgraduate Program in Translational Surgery, UNIFESP, Sao Paulo-SP, Brazil. Conception, design, intellectual and scientific content of the study; interpretation and analysis of data; manuscript writing; critical revision; final approval.""}]",Acta cirurgica brasileira,['10.1590/s0102-865020200090000007']
2844,33027400,Effect of a breastfeeding educational intervention: a randomized controlled trial.,"OBJECTIVE


to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women.
METHOD


this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer's Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24.
RESULTS


the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
CONCLUSION


the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR - 8p9v7v.",2020,"the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
","['104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a']","['soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM', 'educational intervention', 'breastfeeding educational intervention']","['exclusive breastfeeding', 'breastfeeding difficulties']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}]",104.0,0.0764986,"the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group.
","[{'ForeName': 'Erdnaxela Fernandes do Carmo', 'Initials': 'EFDC', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Alfredo Almeida', 'Initials': 'AA', 'LastName': 'Pina-Oliveira', 'Affiliation': ''}, {'ForeName': 'Antonieta Keiko Kakuda', 'Initials': 'AKK', 'LastName': 'Shimo', 'Affiliation': ''}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3081.3335']
2845,33027403,Economic and epidemiological evaluation of text message-based interventions in patients with the Human Immunodeficiency Virus.,"OBJECTIVE


to evaluate the cost-effectiveness ratio and the budget impact of sending text messages associated with medical consultations in order to reduce the viral load of patients infected with the Human Immunodeficiency Virus.
METHOD


a randomized clinical trial, basis for the development of a dynamic cohort model with Markov states in order to compare medical appointments for adults infected with the Human Immunodeficiency Virus versus the alternative strategy that associated medical consultations to sending text messages through telephone.
RESULTS


156 adults participated in the study. As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference. Sending text messages would prevent 286,538 new infections by the Human Immunodeficiency Virus and 282 deaths in the 20-year period, compared to the standard treatment. The alternative strategy would result in saving R$ 14 billion in treatment costs.
CONCLUSION


weekly sending messages in association with the standard treatment can reduce the circulating viral load due to its effect in decreasing new infections, in addition to reducing health costs.",2020,"As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference.","['156 adults participated in the study', 'patients with the Human Immunodeficiency Virus', 'adults infected with the Human Immunodeficiency Virus versus the alternative strategy that associated medical consultations to sending text messages through telephone', 'patients infected with the Human Immunodeficiency Virus']",['text message-based interventions'],['cost-effectiveness ratio'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",156.0,0.0270667,"As for the viral load, it was verified that in the control group there was an increase, in the intervention group A (weekly messages) there was a reduction (p = 0.002) and in group B (biweekly messages) there was no statistically significant difference.","[{'ForeName': 'Wendel Mombaque Dos', 'Initials': 'WMD', 'LastName': 'Santos', 'Affiliation': 'Empresa Brasileira de Serviços Hospitalares, Hospital Universitário de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Marcelo Ribeiro', 'Initials': 'MR', 'LastName': 'Primeira', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}, {'ForeName': 'Larissa Garcia de', 'Initials': 'LG', 'LastName': 'Paiva', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}, {'ForeName': 'Stela Maris de Mello', 'Initials': 'SMM', 'LastName': 'Padoin', 'Affiliation': 'Universidade Federal de Santa Maria, Departamento de Enfermagem, Santa Maria, RS, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3614.3365']
2846,33027431,[Quality of diet and daily spending on food by adults with cardiovascular disease in Brazil].,"Adherence to a healthy diet depends on factors such as food prices, while studies in developed countries have identified higher costs of more nutritional foods. The current study aimed to assess the direct food expenditures by adults with cardiovascular disease in Brazil, investigating the relationship between cost and quality of diet. The study used data from a randomized clinical trial, the BALANCE Program. The current study is a cross-sectional baseline analysis of participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil. Food consumption by 1,160 individuals was collected with a 24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs were estimated from market prices. No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics. When all the 24HR were analyzed, there was no correlation between cost and quality of diet (r = 0.38; p = 0.17), while analysis by tertiles showed a weak correlation in the lowest tertile of adherence (r = -0.112; p = 0.03). The study showed absence of differences between direct costs of healthy versus unhealthy foods, a finding that can serve as an incentive for adherence to food recommendations in Brazil, thereby minimizing barriers to the adoption of healthy lifestyles.",2020,No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics.,"['participants with high adherence to the trial, conducted in 35 sites in all five major geographic regions of Brazil', 'adults with cardiovascular disease in Brazil']",[],"['cost and quality of diet', 'direct costs of food or individual characteristics', '24-hour dietary recall (24HR), quality of diet was measured with the Diet Quality Index Revised (DQI-R), and direct food costs']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.0446129,No significant differences were observed between tertiles of adherence in the direct costs of food or individual characteristics.,"[{'ForeName': 'Camila Ragne', 'Initials': 'CR', 'LastName': 'Torreglosa', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Flávia Mori', 'Initials': 'FM', 'LastName': 'Sarti', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Ângela Cristine', 'Initials': 'ÂC', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'Hospital do Coração, São Paulo, Brasil.'}, {'ForeName': 'Bernardete', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Hospital do Coração, São Paulo, Brasil.'}, {'ForeName': 'Renato Hideo Nakagawa', 'Initials': 'RHN', 'LastName': 'Santos', 'Affiliation': 'Hospital do Coração, São Paulo, Brasil.'}, {'ForeName': 'Alexandre D P', 'Initials': 'ADP', 'LastName': 'Chiavegatto Filho', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brasil.'}]",Cadernos de saude publica,['10.1590/0102-311X00225019']
2847,33027448,Children First Study II: an educational programme on cardiovascular prevention in public schools can reduce parents' cardiovascular risk.,"OBJECTIVE


The aim of this study was to analyze whether the implementation of a multidisciplinary educational programme for cardiovascular prevention in public schools can contribute to reducing the FramINGHAM CARDIOVASCULAR RISK SCORE OF THE CHILDREN'S PARENTS AFTER ONE YEAR.
METHODS


This was a prospective, community-based, case-control study carried out in public schools in Sao Paulo, Brasil. Students were randomized to receive healthy lifestyle recommendations by two different approaches. The control group received written cardiovascular health educational brochures for their parents. The intervention group received the same brochures for the parents, and the children were exposed to a weekly educational programme on cardiovascular prevention with a multidisciplinary health team for one year. Clinical and laboratorial data were collected at the onset and end of the study.
RESULTS


We studied 265 children and their 418 parents. At the baseline, the rate of parents with intermediate or high Framingham scores (risk of cardiovascular disease over the next 10 years greater than 10%) was 6.9% in the control group and 13.3% in the intervention group. After one year, the rate of parents with intermediate or high Framingham risk score was reduced by 22.2% in the intervention group and increased by 33.3% in the control group (p=0.031). The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
CONCLUSION


An educational programme on cardiovascular prevention for school-age children in public schools can reduce the cardiovascular risk of their parents.",2020,"The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
","['265 children and their 418 parents', 'public schools', 'school-age children in public schools', 'public schools in Sao Paulo, Brasil']","['written cardiovascular health educational brochures', 'multidisciplinary educational programme', 'educational programme on cardiovascular prevention with a multidisciplinary health team for one year', 'educational programme']","['cardiovascular risk factors', 'rate of parents with intermediate or high Framingham scores (risk of cardiovascular disease', 'blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels', 'rate of parents with intermediate or high Framingham risk score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",265.0,0.0383702,"The cardiovascular risk factors that improved in the intervention group were blood pressure, LDL-cholesterol (low-density lipoprotein cholesterol), and glucose levels.
","[{'ForeName': 'Cristiano J M', 'Initials': 'CJM', 'LastName': 'Pinto', 'Affiliation': 'Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Luciana S', 'Initials': 'LS', 'LastName': 'Fornari', 'Affiliation': 'Universidade de São Paulo, São Paulo, SP, Brasil.'}, {'ForeName': 'Silvia M R', 'Initials': 'SMR', 'LastName': 'Oyama', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Maria M D', 'Initials': 'MMD', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Taciana', 'Initials': 'T', 'LastName': 'Davanço', 'Affiliation': 'Universidade Padre Anchieta, São Paulo, SP, Brasil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Caramelli', 'Affiliation': 'InCor, Universidade de São Paulo, São Paulo, SP, Brasil.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.9.1217']
2848,33027488,Educational intervention with serial album about pregnant women positioning for spinal anesthesia: randomized clinical trial.,"OBJECTIVE


To evaluate effectiveness of using educational intervention serial album to positioning pregnant women for spinal anesthesia.
METHOD


Randomized clinical trial with 90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil. The primary endpoint was ""achieve correct positioning to perform spinal anesthesia""; and secondary, ""how number of spinal cord puncture attempts"". Effectiveness was verified using the chi-square test, Fisher's exact test and likelihood ratio.
RESULTS


The positioning was correct in 37 women in each group. There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture.
CONCLUSION


Educational intervention with serial album was effective and contributed to immobility and positioning of pregnant women. Brazilian Registry of Clinical Trials (RBR-3Z7SRD).",2020,"There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture.
","['pregnant women for spinal anesthesia', 'about pregnant women positioning for spinal anesthesia', 'pregnant women', '90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil', '37 women in each group']","['Educational intervention with serial album', 'educational intervention serial album']","['achieve correct positioning to perform spinal anesthesia""; and secondary, ""how number of spinal cord puncture attempts']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",90.0,0.0811567,"There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture.
","[{'ForeName': 'Sarah de Lima', 'Initials': 'SL', 'LastName': 'Pinto', 'Affiliation': 'Universidade Regional do Cariri. Crato, Ceará, Brazil.'}, {'ForeName': 'Larissa Alves', 'Initials': 'LA', 'LastName': 'Sampaio', 'Affiliation': 'Universidade Regional do Cariri. Crato, Ceará, Brazil.'}, {'ForeName': 'Nelson Miguel', 'Initials': 'NM', 'LastName': 'Galindo Neto', 'Affiliation': 'Instituto Federal de Educação, Ciência e Tecnologia de Pernambuco. Pesqueira, Pernambuco, Brazil.'}, {'ForeName': 'Paulo César de', 'Initials': 'PC', 'LastName': 'Almeida', 'Affiliation': 'Universidade Estadual do Ceará. Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Mirna Fontenele de', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Cariri. Barbalha, Ceará, Brazil.'}, {'ForeName': 'Joselany Áfio', 'Initials': 'JÁ', 'LastName': 'Caetano', 'Affiliation': 'Universidade Federal do Ceará. Fortaleza, Ceará, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2019-0878']
2849,33027506,Economic Threat Heightens Conflict Detection: sLORETA evidence.,"Economic threat has far-reaching emotional and social consequences, yet the impact of economic threat on neurocognitive processes has received little empirical scrutiny. Here, we examined the causal relationship between economic threat and conflict detection, a critical process in cognitive control associated with the anterior cingulate cortex (ACC). Participants (N = 103) were first randomly assigned to read about a gloomy economic forecast (Economic Threat condition) or a stable economic forecast (No-Threat Control condition). Notably, these forecasts were based on real, publicly available economic predictions. Participants then completed a passive auditory oddball task comprised of frequent standard tones and infrequent, aversive white-noise bursts, a task that elicits the N2, an event-related potential (ERP) component linked to conflict detection. Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli. Further, ACC activation to conflict mediated an effect of Economic Threat on increased justification for personal wealth. Economic threat thus has implications for basic neurocognitive function. Discussion centers on how effects on conflict detection could shed light on the broader emotional and social consequences of economic threat.",2020,Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli.,['Participants (N = 103'],"['passive auditory oddball task comprised of frequent standard tones and infrequent, aversive white-noise bursts, a task that elicits the N2, an event-related potential (ERP) component linked to conflict detection', 'read about a gloomy economic forecast (Economic Threat condition) or a stable economic forecast (No-Threat Control condition']",[],"[{'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],103.0,0.0127463,Results revealed that participants in the Economic Threat condition evidenced increased activation source localized to the ACC during the N2 to white-noise stimuli.,"[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Nash', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Leot', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, University of Alberta, Edmonton, Canada.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa139']
2850,33026741,Interferon Beta-1b and Lopinavir-Ritonavir for Middle East Respiratory Syndrome.,"BACKGROUND


Whether combined treatment with recombinant interferon beta-1b and lopinavir-ritonavir reduces mortality among patients hospitalized with Middle East respiratory syndrome (MERS) is unclear.
METHODS


We conducted a randomized, adaptive, double-blind, placebo-controlled trial that enrolled patients at nine sites in Saudi Arabia. Hospitalized adults with laboratory-confirmed MERS were randomly assigned to receive recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo for 14 days. The primary outcome was 90-day all-cause mortality, with a one-sided P-value threshold of 0.025. Prespecified subgroup analyses and safety analyses were conducted. Because of the pandemic of coronavirus disease 2019, the data and safety monitoring board requested an unplanned interim analysis and subsequently recommended the termination of enrollment and the reporting of the results.
RESULTS


A total of 95 patients were enrolled; 43 patients were assigned to the intervention group and 52 to the placebo group. A total of 12 patients (28%) in the intervention group and 23 (44%) in the placebo group died by day 90. The analysis of the primary outcome, with accounting for the adaptive design, yielded a risk difference of -19 percentage points (upper boundary of the 97.5% confidence interval [CI], -3; one-sided P = 0.024). In a prespecified subgroup analysis, treatment within 7 days after symptom onset led to lower 90-day mortality than use of placebo (relative risk, 0.19; 95% CI, 0.05 to 0.75), whereas later treatment did not. Serious adverse events occurred in 4 patients (9%) in the intervention group and in 10 (19%) in the placebo group.
CONCLUSIONS


A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS. The effect was greatest when treatment was started within 7 days after symptom onset. (Funded by the King Abdullah International Medical Research Center; MIRACLE ClinicalTrials.gov number, NCT02845843.).",2020,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"['A total of 95 patients were enrolled; 43 patients', 'Hospitalized adults with laboratory-confirmed MERS', 'enrolled patients at nine sites in Saudi Arabia', 'Middle East Respiratory Syndrome', 'patients hospitalized with Middle East respiratory syndrome (MERS', 'patients who had been hospitalized with laboratory-confirmed MERS']","['Interferon Beta-1b and Lopinavir-Ritonavir', 'placebo', 'recombinant interferon beta-1b and lopinavir-ritonavir', 'recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo']","['90-day all-cause mortality', 'Serious adverse events', '90-day mortality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.768763,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ayed Y', 'Initials': 'AY', 'LastName': 'Asiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Assiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanan H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al Jeraisy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed H A', 'Initials': 'MHA', 'LastName': 'Azzam', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulhadi M', 'Initials': 'AM', 'LastName': 'Bin Eshaq', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Al Johani', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shmeylan', 'Initials': 'S', 'LastName': 'Al Harbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hani A A', 'Initials': 'HAA', 'LastName': 'Jokhdar', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Deeb', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameeh', 'Initials': 'S', 'LastName': 'Ghazal', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Al Faraj', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Al Mekhlafi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nisreen M', 'Initials': 'NM', 'LastName': 'Sherbeeni', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fatehi E', 'Initials': 'FE', 'LastName': 'Elzein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Al Saedi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Naif K', 'Initials': 'NK', 'LastName': 'Alharbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelzaher', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wail', 'Initials': 'W', 'LastName': 'Bajhmom', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Badriah M', 'Initials': 'BM', 'LastName': 'AlMutairi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015294']
2851,33021870,Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial.,"PURPOSE


Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed.
PATIENTS AND METHODS


The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization.
RESULTS


Patients were randomly assigned to receive ixazomib (n = 425) or placebo (n = 281). TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25.6  v  12.9 months; HR, 0.586;  P  < .001). With ixazomib versus placebo, 36.6% versus 23.2% of patients had grade ≥ 3 treatment-emergent adverse events (TEAEs); 12.9% versus 8.0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26.8%  v  8.0%), vomiting (24.2%  v  4.3%), and diarrhea (23.2%  v  12.3%). There was no increase in new primary malignancies (5.2%  v  6.2%); rates of on-study deaths were 2.6% versus 2.2%.
CONCLUSION


Ixazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.",2020,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","['Patients', 'Patients With Newly Diagnosed Multiple Myeloma', 'patients with NDMM not undergoing ASCT', 'patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT', 'MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of']","['Ixazomib maintenance', 'Autologous Stem Cell Transplantation', 'standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo', 'placebo', 'ixazomib', 'ixazomib versus placebo', 'Ixazomib']","['diarrhea', 'risk of progression or death', 'nausea', 'complete or very good partial response postinduction', 'new primary malignancies', 'vomiting', 'PFS since time of randomization', 'rates of on-study deaths', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",,0.215654,"TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4  v  9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801;  P  < .001; median follow-up, 21.1 months).","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'First Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""Department of Hematology, University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Oriol', 'Affiliation': ""Institut d'Investigació contra la Leucèmia Josep Carreras and Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hemato-oncology, University Hospital Ostrava, University of Ostrava, and Faculty of Medicine, Ostrava, Czech Republic.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'Hematology, Leicester Royal Infirmary/University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Katodritou', 'Affiliation': 'Department of Hematology, Theagenion Cancer Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, National University Health System, and Yong Loo Lin School of Medicine and Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Pôle Régional de Cancérologie, Department of Haematology, Centre Hospitalier Universitaire La Milétrie-Poitiers, Poitiers, France.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer, (Universitario de Salamanca Consejo Superior de Investigaciones Científicas), Salamanca, Spain.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Vorog', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02060']
2852,33021871,Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of  EGFR -Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403.,"PURPOSE


The irreversible ErbB family tyrosine kinase inhibitor (TKI) afatinib plus the EGFR monoclonal antibody cetuximab was previously shown to overcome resistance to EGFR TKIs. We studied whether the combination of afatinib plus cetuximab compared with afatinib alone would improve progression-free survival (PFS) in patients with treatment-naive  EGFR -mutant non-small-cell lung cancer (NSCLC) by preventing or delaying resistance.
METHODS


Patients with  EGFR -mutant NSCLC without prior treatment of advanced disease were enrolled in this phase II, multicenter trial and randomly assigned to receive afatinib 40 mg orally daily plus cetuximab 500 mg/m 2  intravenously every 2 weeks or afatinib alone. The primary end point was PFS.
RESULTS


Between March 25, 2015 and April 23, 2018, 174 patients were randomly assigned, and 168 (83 on afatinib + cetuximab and 85 on afatinib) were eligible. There was no improvement in PFS in patients receiving afatinib plus cetuximab compared with afatinib alone (hazard ratio [HR], 1.01; 95% CI, 0.72 to 1.43;  P  = .94; median, 11.9 months  v  13.4 months). Similarly, there was no difference in response rate (67%  v  74%;  P  = .38) or overall survival (HR, 0.82; 95% CI, 0.50 to 1.36;  P  = .44). Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea. Dose reductions were more common in patients receiving the combination, and 30% of patients in this arm discontinued cetuximab due to toxicity. At interim analysis, there was insufficient evidence to support continued accrual, and the trial was closed.
CONCLUSIONS


The addition of cetuximab to afatinib did not improve outcomes in previously untreated  EGFR -mutant NSCLC, despite recognized activity in the acquired resistance setting.",2020,"Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea.","['Patients with  EGFR -mutant NSCLC without prior treatment of advanced disease', 'patients with treatment-naive  EGFR -mutant non-small-cell lung cancer (NSCLC) by preventing or delaying resistance', 'First-Line Treatment of', 'Non-Small-Cell Lung Cancer', '174 patients were randomly assigned, and 168 (83 on', 'Between March 25, 2015 and April 23, 2018']","['afatinib plus cetuximab', 'afatinib 40 mg orally daily plus cetuximab 500 mg/m 2  intravenously every 2 weeks or afatinib alone', 'EGFR -Mutant', 'afatinib + cetuximab and 85 on afatinib', 'Afatinib Plus Cetuximab Versus Afatinib Alone', 'afatinib alone']","['Toxicity', 'progression-free survival (PFS', 'toxicity', 'response rate', 'PFS', 'rash and diarrhea', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3652037', 'cui_str': 'Afatinib 40 MG [Gilotrif]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",174.0,0.11611,"Toxicity was greater with the combination: grade ≥ 3 adverse events related to treatment occurred in 72% of patients receiving afatinib plus cetuximab compared with 40% of those receiving afatinib alone, most commonly rash and diarrhea.","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Lilenbaum', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Politi', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke Cancer Center, Durham, NC.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Everett H', 'Initials': 'EH', 'LastName': 'Chen', 'Affiliation': 'Kaiser Permanente Medical Group/NCORP, Bellflower CA.'}, {'ForeName': 'Sandeep H', 'Initials': 'SH', 'LastName': 'Mashru', 'Affiliation': 'Kaiser Permanente Medical Group/NCORP, Portland, OR.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Melnick', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Baumgart', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01149']
2853,33021877,Diffusion in social norms change about violence against women: A longitudinal analysis of intervention data from a cluster randomised trial.,"This study examines the diffusion effects of a Social and Behaviour Change Communication intervention in Nepal targeting gender equity and violence against women. The  Change  trial involves weekly radio programming, listening and discussion groups (LDGs), and community engagement. This longitudinal study analyses a repeated cross-sectional two-armed, pair-matched, single blinded cluster trial of a 9-month intervention. We used probability proportionate to size methodology to identify 72 wards in the Terai region, half of which were randomly assigned to the intervention. For the community-based survey, 20 women per ward were chosen using simple random sampling ( N  = 1440). Ten women from each intervention ward ( N  = 360) were also selected to participate in radio LDGs. Injunctive norms were measured with the Partner Violence Norms Scale-PVNS. Each one person increase in diffusion was associated with a 0.04 (SE = 0.01,  p -value < 0.01) higher endline norms score, adjusting for confounders. There was evidence of effect modification with a significant baseline norm by diffusion interaction term (Estimate = -0.12,  p -value = 0.04). Findings demonstrated that diffusion was related to endline norms only in communities with lower baseline levels of gender equitable norms. Study findings support the importance of diffusion as a pathway to intervention scale-up and norms change.",2020,"There was evidence of effect modification with a significant baseline norm by diffusion interaction term (Estimate = -0.12,  p -value = 0.04).","['social norms change about violence against women', 'Nepal targeting gender equity and violence against women', 'Ten women from each intervention ward ( N  = 360', '20 women per ward were chosen using simple random sampling ( N  = 1440', '72 wards in the Terai region, half of which']",['Social and Behaviour Change Communication intervention'],[],"[{'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}]",[],10.0,0.044273,"There was evidence of effect modification with a significant baseline norm by diffusion interaction term (Estimate = -0.12,  p -value = 0.04).","[{'ForeName': 'Cari Jo', 'Initials': 'CJ', 'LastName': 'Clark', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Batayeh', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Prabin Nanicha', 'Initials': 'PN', 'LastName': 'Shrestha', 'Affiliation': 'Equal Access International, Washington, DC, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Binita', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Equal Access International, Washington, DC, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'Equal Access International, Washington, DC, USA.'}]",Global public health,['10.1080/17441692.2020.1828984']
2854,33022010,"Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.","BACKGROUND


Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB.
METHODS AND FINDINGS


We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data.
CONCLUSIONS


In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability.
TRIAL REGISTRATION


We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.",2020,The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742).,"['Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree', ""Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco"", ' (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE', 'inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB', 'women at increased risk of preterm birth', 'women with identified risk factors for PTB', 'women at increased risk of PTB in an inner-city maternity service in London (UK', 'Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women']","['POPPIE', ""midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas"", 'Midwifery continuity of care versus standard maternity care']","['eligibility, recruitment and attrition rates, and fidelity of the model', 'composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth', 'preterm birth (PTB) and improve perinatal survival', 'skin-to-skin contact', 'number of serious adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C4324509', 'cui_str': 'Late miscarriage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0266383', 'cui_str': 'Congenital uterine anomaly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4517729', 'cui_str': '334'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",334.0,0.229271,The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742).,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez Turienzo', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Bollard', 'Affiliation': 'Maternity Services, Lewisham and Greenwich NHS Trust, London, United Kingdom.'}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Coxon', 'Affiliation': ""Department of Midwifery, Kingston University and St. George's, University of London, United Kingdom.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cross', 'Affiliation': 'Department of Public Health, London Borough of Lewisham, London, United Kingdom.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Silverio', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Tribe', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003350']
2855,33022048,Brief Behavioral Treatment for Insomnia Improves Psychosocial Functioning in Veterans: Results from a Randomized Controlled Trial.,"STUDY OBJECTIVES


Our goal was to compare Brief Behavioral Treatment for Insomnia (BBTI) to a Progressive Muscle Relaxation Training (PMRT) control condition among veterans with insomnia, examining psychosocial functioning as a primary outcome and sleep-related outcomes, mood, cognition, and pain as secondary outcomes.
METHODS


Veterans were randomly assigned to either BBTI or PMRT (N=91; 24-74 years; M=49 years). BBTI consisted of two in-person (60-minute and 30-minute sessions) and two telephone sessions (20-minutes each), and the PMRT control condition was matched to BBTI for session duration and type. Veterans were assessed through clinical interview at baseline and self-report measures at pre- mid- and post-treatment, as well as six-month follow-up for the BBTI condition to assess sustained response. Measures also included continuous sleep monitoring with sleep diary.
RESULTS


Intent-to-treat analyses demonstrated that individuals who completed BBTI vs. PMRT reported greater improvements in work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy. Improvements in psychosocial functioning, insomnia symptoms and mood were maintained six-months following BBTI treatment completion.
CONCLUSIONS


Veterans who received BBTI improved and maintained gains in psychosocial functioning, insomnia and mood. BBTI is a treatment that can be implemented in primary care, mental health, or integrated care settings and provide symptom relief and improved functioning among those with insomnia, one of the most commonly reported mental health problems among veterans.",2020,"RESULTS


Intent-to-treat analyses demonstrated that individuals who completed BBTI vs. PMRT reported greater improvements in work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy.","['Insomnia Improves Psychosocial Functioning in Veterans', 'Veterans', 'veterans with insomnia']","['BBTI or PMRT', 'Progressive Muscle Relaxation Training (PMRT) control condition', 'Brief Behavioral Treatment']","['work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy', 'psychosocial functioning, insomnia and mood', 'continuous sleep monitoring with sleep diary', 'psychosocial functioning, insomnia symptoms and mood']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0416638,"RESULTS


Intent-to-treat analyses demonstrated that individuals who completed BBTI vs. PMRT reported greater improvements in work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy.","[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Maguen', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gloria', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Huggins', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Lizabeth A', 'Initials': 'LA', 'LastName': 'Goldstein', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kanady', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Straus', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Metzler', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Callan', 'Initials': 'C', 'LastName': 'Lujan', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco Veterans Affairs Health Care System.'}]",Sleep,['10.1093/sleep/zsaa205']
2856,33022089,Comment on: Laparoscopic versus Open Colorectal Surgery in the Acute Setting (LaCeS Trial): A Multicentre Randomized Feasibility Trial.,,2020,,['Acute Setting (LaCeS Trial'],['Laparoscopic versus Open Colorectal Surgery'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0453991', 'cui_str': 'Laces'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]",[],,0.21799,,"[{'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Spence', 'Affiliation': ''}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Perin', 'Affiliation': ''}, {'ForeName': 'Saba P', 'Initials': 'SP', 'LastName': 'Balasubramanian', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.12017']
2857,33022094,Author response to: Comment on: Laparoscopic versus Open Colorectal Surgery in the Acute Setting (LaCeS Trial): A Multicentre Randomized Feasibility Trial.,,2020,,['Acute Setting (LaCeS Trial'],['Laparoscopic versus Open Colorectal Surgery'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0453991', 'cui_str': 'Laces'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]",[],,0.181773,,"[{'ForeName': 'Deena', 'Initials': 'D', 'LastName': 'Harji', 'Affiliation': 'Royal Victoria Infirmary Newcastle Upon Tyne Hospitals NHS Foundation Trust, Queen Victoria Road, The General Infirmary at Leeds, United Kingdom of Great Britain and Northern Ireland.'}]",The British journal of surgery,['10.1002/bjs.12016']
2858,33022318,Treating tobacco dependence to aid Re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION


U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS


Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS


Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS


In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
2859,33022321,Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population.,"Previous research suggests that sending non-participants a reminder letter, 1 year after their initial invitation, can improve coverage for bowel scope screening (BSS), also known as flexible sigmoidoscopy screening. We hypothesised that adding a general practitioner's (GPs) endorsement to the reminder letter could improve coverage even further. We conducted a randomised controlled trial in North West London, UK. Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12 months prior to the trial period. Eligible adults were randomised in a 1:1 ratio to receive either a GP-endorsed reminder letter, or a standard reminder letter from June to August 2019. Logistic regression models were used to test the effect of the GP endorsement on attendance at BSS, adjusting for sex, clinical commissioning group, and local area socioeconomic deprivation. In total, 1200 participants were enrolled into the study and randomised to either the control (n = 600) or the intervention (n = 600) group. Those who received the GP-endorsed reminder letter were only slightly more likely to attend BSS than those who received the standard reminder letter (4% vs. 3%); this difference was not statistically significant (Adjusted OR = 1.30; 95% CI: 0.69, 2.43). Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS. One possible explanation for this is that the endorsement used was not personalised enough. Future research should examine stronger GP-endorsements or other methods to promote uptake.",2020,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"['Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12\u202fmonths prior to the trial period', 'North West London, UK', 'Eligible adults', '1200 participants were enrolled into the study and randomised to either the control (n\u202f=\u202f600) or the intervention (n\u202f=\u202f600) group']","['GP-endorsed reminder letter, or a standard reminder letter from June to August 2019', 'GP-endorsed non-participant reminder letter']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],1200.0,0.121819,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK. Electronic address: aradhna.kaushal.14@ucl.ac.uk.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tookey', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106268']
2860,33022324,Fit and strong! plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = .049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = .04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = .004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = .046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = .045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
2861,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES


We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS


This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS


A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43)  = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS


Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodological and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodological and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
2862,33027559,Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX.,"BACKGROUND


CanAssist Breast (CAB) is a prognostic test for early stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients, validated on Indian and Caucasian patients. The 21-gene signature Oncotype DX (ODX) is the most widely used commercially available breast cancer prognostic test. In the current study, risk stratification of CAB is compared with that done with ODX along with the respective outcomes of these patients.
METHODS


A cohort of 109 early stage breast cancer patients who had previously taken the ODX test were retested with CAB, and the results respectively compared with old cut-offs of ODX as well as cut-offs suggested by TAILORx, a prospective randomized trial of ODX. Distant metastasis-free survival after 5 years was taken as the end point.
RESULTS


CanAssist Breast stratified 83.5% of the cohort into low-risk and 16.5% into high-risk. With the TAILORx cut-offs, ODX stratified the cohort into 89.9% low-risk and 10.1% into high-risk. The low, intermediate, and high-risk groups with ODX old cut-offs were 62.4%, 31.2%, and 6.4%, respectively. The overall concordance of CAB with ODX using both cut-offs is 75%-76%, with ~82%-83% concordance in the low-risk category of these tests. The NPV of the low-risk category of CAB was 93.4%, and of ODX with TAILORx cut-offs was 91.8% and 89.7% with old cut-offs.
CONCLUSIONS


Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort. CAB is thus an excellent and cost-effective alternative to ODX.",2020,"Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort.","['109 early stage breast cancer patients who had previously taken the ODX test were retested with', 'Indian and Caucasian patients']","['CanAssist Breast (CAB', 'CAB', 'breast cancer prognostic tests CanAssist Breast and Oncotype DX']","['Distant metastasis-free survival', 'overall concordance of CAB with ODX']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]",109.0,0.0244953,"Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort.","[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Sengupta', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Gunda', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Sukriti', 'Initials': 'S', 'LastName': 'Malpani', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Chandra Prakash V', 'Initials': 'CPV', 'LastName': 'Serkad', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Chetana', 'Initials': 'C', 'LastName': 'Basavaraj', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Bapat', 'Affiliation': 'Virtua Hospital, Voorhees, NJ, USA.'}, {'ForeName': 'Manjiri M', 'Initials': 'MM', 'LastName': 'Bakre', 'Affiliation': 'OncoStem Diagnostics, Bangalore, Karnataka, India.'}]",Cancer medicine,['10.1002/cam4.3495']
2863,33027677,Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake.,,2020,,[],"['Ad Libitum Food Intake', 'Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain']",[],[],"[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",[],,0.173456,,"[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ayuketah', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brychta', 'Affiliation': ''}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cassimatis', 'Affiliation': ''}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Courville', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Darcey', 'Affiliation': ''}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Ciaran G', 'Initials': 'CG', 'LastName': 'Forde', 'Affiliation': ''}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Gharib', 'Affiliation': ''}, {'ForeName': 'Juen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Paule V', 'Initials': 'PV', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGehee', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ouwerkerk', 'Affiliation': ''}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Raisinger', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rozga', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stagliano', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}]",Cell metabolism,['10.1016/j.cmet.2020.08.014']
2864,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
2865,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM


During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS


Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS


From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS


The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto L R', 'Initials': 'ULR', 'LastName': 'Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
2866,33027748,Renal protection with glucagon-like peptide-1 receptor agonists.,"There is an unmet need for renoprotective drugs for more pronounced reduction of albuminuria beyond that provided by renin-angiotensin system (RAS) blockers and for effective slowdown of eGFR decline independent of albuminuria. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have proven effective in reducing prespecified secondary composite kidney outcomes in cardiovascular outcome trials. However, GLP-1 RAs showed a prevailing anti-albuminuric effect, additional to that of RAS blockers, and a non-significant risk reduction in worsening of kidney function, at variance with sodium-glucose cotransporter 2 inhibitors. Mechanisms underlying renal protection with GLP-1 RAs are porly understood. Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results. Anti-inflammatory/anti-oxidant effects via intracellular signalling through protein kinase A, natriuretic effect via inhibition of sodium-hydrogen exchanger 3 and reduction of hyperfiltration have been proposed as direct renoprotective effects.",2020,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.",[],"['Glucagon-like peptide-1 receptor agonists (GLP-1 RAs', 'GLP-1 RAs', 'glucagon-like peptide-1 receptor agonists']","['glycaemic, blood pressure and body weight control']",[],"[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0545075,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cirrito', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy. Electronic address: giuseppe.pugliese@uniroma1.it.'}]",Current opinion in pharmacology,['10.1016/j.coph.2020.08.018']
2867,33027758,Effects of a Curriculum-Integrated Dance Program on Children's Physical Activity.,"BACKGROUND


Curriculum-integrated dance programs are a promising but relatively under-researched strategy for increasing children's physical activity (PA). The aim of this study was to determine the impact of a curriculum-integrated dance program on children's PA.
METHODS


A total of 134 primary children aged 7-9 years from 4 New Zealand schools were assigned to either a dance group (n = 78) or a control group (n = 56). The dance group participated in a 6-week curriculum-integrated dance program during school time. Although the dance program focused on curricular learning, fitness and coordination were embedded in the dance sessions. Intensity of PA varied according to the focus of each dance session. PA was measured at baseline and postintervention using a waist-mounted ActiGraph GT3X+ accelerometer for 8 consecutive days.
RESULTS


There were no significant intervention effects on PA levels between the dance and control groups postintervention.
CONCLUSION


Dance-embedded learning did not increase overall levels of PA in this study. Future studies may consider assessing longer term effects of a dance-based intervention, or programs that place more focus on PA promotion.",2020,"There were no significant intervention effects on PA levels between the dance and control groups postintervention.
","[""Children's Physical Activity"", ""children's PA"", '134 primary children aged 7-9\xa0years from 4 New Zealand schools']","['curriculum-integrated dance program', 'ActiGraph GT3X+ accelerometer', '6-week curriculum-integrated dance program', 'Curriculum-Integrated Dance Program']","['Intensity of PA', 'PA', 'overall levels of PA', 'PA levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",134.0,0.0162745,"There were no significant intervention effects on PA levels between the dance and control groups postintervention.
","[{'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Duncan', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2020-0164']
2868,33028101,"PAR1 (Protease-Activated Receptor 1) Pepducin Therapy Targeting Myocardial Necrosis in Coronary Artery Disease and Acute Coronary Syndrome Patients Undergoing Cardiac Catheterization: A Randomized, Placebo-Controlled, Phase 2 Study.","OBJECTIVE


Arterial thrombosis leading to ischemic injury worsens the prognosis of many patients with cardiovascular disease. PZ-128 is a first-in-class pepducin that reversibly inhibits PAR1 (protease-activated receptor 1) on platelets and other vascular cells by targeting the intracellular surface of the receptor. The TRIP-PCI (Thrombin Receptor Inhibitory Pepducin in Percutaneous Coronary Intervention) trial was conducted to assess the safety and efficacy of PZ-128 in patients undergoing cardiac catheterization with intent to perform percutaneous coronary intervention. Approach and Results: In this randomized, double-blind, placebo-controlled, phase 2 trial, 100 patients were randomly assigned (2:1) to receive PZ-128 (0.3 or 0.5 mg/kg), or placebo in a 2-hour infusion initiated just before the start of cardiac catheterization, on top of standard oral antiplatelet therapy. Rates of the primary end point of bleeding were not different between the combined PZ-128 doses (1.6%, 1/62) and placebo group (0%, 0/35). The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively). In the subgroup of patients with elevated baseline cardiac troponin I, the exploratory end point of 30-day major adverse coronary events + myocardial injury showed 83% events in the placebo group versus 31% events in the combined PZ-128 drug groups, an adjusted relative risk of 0.14 (95% CI, 0.02-0.75);  P =0.02.
CONCLUSIONS


In this first-in-patient experience, PZ-128 added to standard antiplatelet therapy appeared to be safe, well tolerated, and potentially reduced periprocedural myonecrosis, thus providing the basis for further clinical trials.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02561000.",2020,"The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively).","['Undergoing Cardiac Catheterization', 'Coronary Artery Disease and Acute Coronary Syndrome Patients', 'patients with elevated baseline cardiac troponin', 'patients undergoing cardiac catheterization with intent to perform percutaneous coronary intervention', '100 patients', 'patients with cardiovascular disease']","['PZ-128', 'placebo', 'Placebo', 'PAR1 (Protease-Activated Receptor 1) Pepducin Therapy']","['major adverse coronary events', 'safety and efficacy', '30-day major adverse coronary events + myocardial injury', 'bleeding']","[{'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0668084', 'cui_str': 'PAR-1 Receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",100.0,0.515208,"The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively).","[{'ForeName': 'Athan', 'Initials': 'A', 'LastName': 'Kuliopulos', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Inova Fairfax Hospital, Falls Church, VA and Sinai Hospital of Baltimore, MD (P.A.G., K.P.B.).'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Rade', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester (J.J.R).'}, {'ForeName': 'Carey D', 'Initials': 'CD', 'LastName': 'Kimmelstiel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, MA (C.D.K.).'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Turner', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Bliden', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Inova Fairfax Hospital, Falls Church, VA and Sinai Hospital of Baltimore, MD (P.A.G., K.P.B.).'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Fletcher', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Cox', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Covic', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.315168']
2869,33028102,"Randomized, placebo-controlled trial of xyloglucan and gelose for the treatment of acute diarrhea in children.","BACKGROUND


Oral rehydration is the main treatment of acute diarrhea in children. This study was undertaken to evaluate the efficacy and safety of xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS) compared with placebo and ORS for reduction of acute diarrhea symptoms in children.
METHODS


In a randomized, double-blind, placebo-controlled trial, children with acute gastroenteritis received xyloglucan/gelose plus ORS (n = 50) or placebo plus ORS (n = 50) for five days. Demographic, clinical, anthropometric and laboratory parameters were recorded and analyzed.
RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment. Xyloglucan/gelose plus ORS also improved associated clinical symptoms (apathy, vomiting, flatulence, and blood in stool). compared with placebo plus ORS. Except for a generalized rash of unknown causality in a patient receiving placebo plus ORS, all other adverse events (dehydration, n = 7, cough, n = 1, exacerbation of vomiting, n = 1) were deemed unrelated to study medication.
CONCLUSIONS


Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children.",2020,"RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment.","['children', 'children with acute gastroenteritis received', 'acute diarrhea in children', 'n = 50) or']","['placebo plus ORS', 'placebo and ORS', 'xyloglucan/gelose plus ORS', 'placebo', 'xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS', 'xyloglucan', 'Xyloglucan/gelose plus ORS']","['clinical symptoms (apathy, vomiting, flatulence, and blood in stool', 'efficacy and safety', 'total number of type 7 and 6 stools on the Bristol Stool Form scale', 'acute diarrhea symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0078641', 'cui_str': 'xyloglucan'}, {'cui': 'C0001771', 'cui_str': 'Agar'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]",1.0,0.693173,"RESULTS


Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( p  = 0.040 and  p  = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""Grup de Neuro-Inmuno-Gastroenterología, Unitat de Fisiología i Fisiopatología Digestiva, Vall d'Hebron Institut de Recerca (VHIR).""}, {'ForeName': 'Virgil', 'Initials': 'V', 'LastName': 'Musta', 'Affiliation': 'Victor Babes University of Medicine and Pharmacy - Timisoara.'}, {'ForeName': 'Catalina Mihaela', 'Initials': 'CM', 'LastName': 'Luca', 'Affiliation': 'Grigore T Popa University of Medicine and Pharmacy - Iasi.'}, {'ForeName': 'Oana Andreea', 'Initials': 'OA', 'LastName': 'Belei', 'Affiliation': 'First Pediatric Clinic, Victor Babes University of Medicine and Pharmacy - Timisoara.'}, {'ForeName': 'Simona Claudia', 'Initials': 'SC', 'LastName': 'Cambrea', 'Affiliation': 'Faculty of Medicine, Ovidius University - Constanta.'}]",Expert review of gastroenterology & hepatology,['10.1080/17474124.2021.1833715']
2870,33028129,Health behaviors a year after an early intervention exercise and education program for people with Parkinson's disease.,"Aim:  To evaluate the impact of an early intervention program on exercise behavior and mood in people with Parkinson's disease (PD) 1 year following participation.  Patients & methods:  Education and exercise program participants (n = 152) were followed up for 1 year. Changes in exercise behavior and mood and factors associated with these changes were examined.  Results:  At follow-up, 28% more participants exercised (p < 0.001). Changes in the proportion reporting depression (12% reduction; p = 0.10) or anxiety (4% increase, p = 0.09) were not statistically significant.  Conclusion:  An education and exercise program promoted positive exercise behavior change sustained for a year, supporting the importance of early intervention for people with PD. Future research should explore sustainable ways to encourage prolonged behavior change, including regular follow-up.",2020,"Changes in the proportion reporting depression (12% reduction; p = 0.10) or anxiety (4% increase, p = 0.09) were not statistically significant.  ","['people with PD', ""people with Parkinson's disease"", ""people with Parkinson's disease (PD) 1 year following participation""]","['intervention exercise and education program', 'Education and exercise program participants', 'early intervention program']","['proportion reporting depression', 'anxiety', 'exercise behavior and mood']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",152.0,0.0724926,"Changes in the proportion reporting depression (12% reduction; p = 0.10) or anxiety (4% increase, p = 0.09) were not statistically significant.  ","[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine & Health, University of Sydney, NSW 2006, Australia.'}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Horne', 'Affiliation': 'Department of\xa0Physiotherapy, Calvary Health Care Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Serene S', 'Initials': 'SS', 'LastName': 'Paul', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine & Health, University of Sydney, NSW 2006, Australia.'}]",Neurodegenerative disease management,['10.2217/nmt-2020-0031']
2871,33028147,Cerebrovascular effects of glibenclamide investigated using high-resolution magnetic resonance imaging in healthy volunteers.,"Glibenclamide inhibits sulfonylurea receptor (SUR), which regulates several ion channels including SUR1-transient receptor potential melastatin 4 (SUR1-TRPM4) channel and ATP-sensitive potassium (K ATP ) channel. Stroke upregulates SURl-TRPM4 channel, which causes a rapid edema formation and brain swelling. Glibenclamide may antagonize the formation of cerebral edema during stroke. Preclinical studies showed that glibenclamide inhibits K ATP  channel-induced vasodilation without altering the basal vascular tone. The in vivo human cerebrovascular effects of glibenclamide have not previously been investigated.In a randomized, double-blind, placebo-controlled, three-way cross-over study, we used advanced 3 T MRI methods to investigate the effects of glibenclamide and K ATP  channel opener levcromakalim on mean global cerebral blood flow (CBF) and intra- and extracranial artery circumferences in 15 healthy volunteers. Glibenclamide administration did not alter the mean global CBF and the basal vascular tone. Following levcromakalim infusion, we observed a 14% increase of the mean global CBF and an 8% increase of middle cerebral artery (MCA) circumference, and glibenclamide did not attenuate levcromakalim-induced vascular changes. Collectively, the findings demonstrate the vital role of K ATP  channels in cerebrovascular hemodynamic and indicate that glibenclamide does not inhibit the protective effects of K ATP  channel activation during hypoxia and ischemia-induced brain injury.",2020,Preclinical studies showed that glibenclamide inhibits K ATP  channel-induced vasodilation without altering the basal vascular tone.,"['15 healthy volunteers', 'healthy volunteers']","['glibenclamide and K ATP  channel opener levcromakalim', 'glibenclamide', 'placebo', 'Glibenclamide']","['Cerebrovascular effects', 'mean global cerebral blood flow (CBF) and intra- and extracranial artery circumferences', 'middle cerebral artery (MCA) circumference', 'mean global CBF', 'cerebral edema', 'mean global CBF and the basal vascular tone']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0244960', 'cui_str': 'Cromakalim, (3S-trans)-Isomer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",15.0,0.0885331,Preclinical studies showed that glibenclamide inhibits K ATP  channel-induced vasodilation without altering the basal vascular tone.,"[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Cherie Amalie Waldorff', 'Initials': 'CAW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Assan', 'Initials': 'A', 'LastName': 'Ansari', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gram', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Samaria', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Functional Imaging Unit, Faculty of Health and Medical Sciences, Department of Clinical Physiology, Nuclear Medicine and PET, University of Copenhagen, Rigshospitalet, Denmark.'}, {'ForeName': 'Henrik Bw', 'Initials': 'HB', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Faculty of Health and Medical Sciences, Department of Clinical Physiology, Nuclear Medicine and PET, University of Copenhagen, Rigshospitalet, Denmark.'}, {'ForeName': 'Lene Theil', 'Initials': 'LT', 'LastName': 'Skovgaard', 'Affiliation': 'Department of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Faculty of Health and Medical Sciences, Danish Headache Center, University of Copenhagen, Rigshospitalet Glostrup, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20959294']
2872,33028166,Supine versus prone PCNL in lower calyceal stone: Comparative study in a tertiary care center.,"INTRODUCTION


Renal calculus disease is an age old disease of human being. PCNL (Percutaneous nephrolithotomy) stands as a gold standard treatment for large renal calculus which is traditionally being done in prone position.
OBJECTIVE


To evaluate the safety and efficacy of supine PCNL versus prone PCNL comparing intraoperative time, requirement of relook PCNL, post op hemoglobin drop, post operative hospital stay, post operative complication, SFR ( stone free rate).
METHODS AND MATERIALS


It is a prospective study done in Urology department in a tertiary care center in Eastern India between October 2017 and October 2018. A total of 84 patients with lower calyceal renal stones underwent PCNL, 42 of them in supine and 42 in prone position. Lower calyceal stone, size measuring 1 to 2 cm were included in the study.
RESULTS


The mean intra operative time was 91.76 min in supine group and 85.43 min in prone group with a p value of 0.115. The mean hemoglobin drop was 1.11 g/dl and 1.18 g/dl in supine and prone position, respectively ( p  value 0.75). The mean post operative hospital stay was 4.1 and 3.86 days in supine and prone group ( p  value 0.58), respectively. Two patients in each group require relook PCNL. Stone free rate at 1 month was 95.23% and 90.47% ( p  value 0.9), respectively in case of supine and prone group.
CONCLUSION


Supine PCNL is feasible, comparable to prone PCNL in respect to operative parameters with relatively higher stone free rate though statistically insignificant.",2020,"Stone free rate at 1 month was 95.23% and 90.47% ( p  value 0.9), respectively in case of supine and prone group.
","['84 patients with lower calyceal renal stones underwent PCNL, 42 of them in supine and 42 in prone position', 'Urology department in a tertiary care center in Eastern India between October 2017 and October 2018']","['PCNL (Percutaneous nephrolithotomy) stands', 'Supine versus prone PCNL', 'supine PCNL']","['safety and efficacy', 'operative hospital stay, post operative complication, SFR ( stone free rate', 'mean intra operative time', 'mean post operative hospital stay', 'mean hemoglobin drop', 'Stone free rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}]",84.0,0.0177542,"Stone free rate at 1 month was 95.23% and 90.47% ( p  value 0.9), respectively in case of supine and prone group.
","[{'ForeName': 'Sunirmal', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Department of Urology, Institute of Post Graduate Medical Education & Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Paragmani', 'Initials': 'P', 'LastName': 'Talukdar', 'Affiliation': 'Department of Urology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapan Kumar', 'Initials': 'TK', 'LastName': 'Mandal', 'Affiliation': 'Department of Urology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapas Kumar', 'Initials': 'TK', 'LastName': 'Majhi', 'Affiliation': 'Department of Urology, NRS Medical College, Kolkata, West Bengal, India.'}]",Urologia,['10.1177/0391560320962404']
2873,33028197,Improved haemodynamic stability and cerebral tissue oxygenation after induction of anaesthesia with sufentanil compared to remifentanil: a randomised controlled trial.,"BACKGROUND


Balanced anaesthesia with propofol and remifentanil, compared to sufentanil, often decreases mean arterial pressure (MAP), heart rate (HR) and cardiac index (CI), raising concerns on tissue-oxygenation. This distinct haemodynamic suppression might be attenuated by atropine. This double blinded RCT, investigates if induction with propofol-sufentanil results in higher CI and tissue-oxygenation than with propofol-remifentanil and if atropine has more pronounced beneficial effects on CI and tissue-oxygenation in a remifentanil-based anaesthesia.
METHODS


In seventy patients scheduled for coronary bypass grafting (CABG), anaesthesia was induced and maintained with propofol target controlled infusion (TCI) with a target effect-site concentration (Cet) of 2.0 μg ml - 1  and either sufentanil (TCI Cet 0.48 ng ml - 1 ) or remifentanil (TCI Cet 8 ng ml - 1 ). If HR dropped below 60 bpm, methylatropine (1 mg) was administered intravenously. Relative changes (∆) in MAP, HR, stroke volume (SV), CI and cerebral (SctO 2 ) and peripheral (SptO 2 ) tissue-oxygenation during induction of anaesthesia and after atropine administration were analysed.
RESULTS


The sufentanil group compared to the remifentanil group showed significantly less decrease in MAP (∆ = - 23 ± 13 vs. -36 ± 13 mmHg), HR (∆ = - 5 ± 7 vs. -10 ± 10 bpm), SV (∆ = - 23 ± 18 vs. -35 ± 19 ml) and CI (∆ = - 0.8 (- 1.5 to - 0.5) vs. -1.5 (- 2.0 to - 1.1) l min - 1  m - 2 ), while SctO 2  (∆ = 9 ± 5 vs. 6 ± 4%) showed more increase with no difference in ∆SptO 2  (∆ = 8 ± 7 vs. 8 ± 8%). Atropine caused higher ∆HR (13 (9 to 19) vs. 10 ± 6 bpm) and ∆CI (0.4 ± 0.4 vs. 0.2 ± 0.3 l min - 1  m - 2 ) in sufentanil vs. remifentanil-based anaesthesia, with no difference in ∆MAP, ∆SV and ∆SctO 2  and ∆SptO 2 .
CONCLUSION


Induction of anaesthesia with propofol and sufentanil results in improved haemodynamic stability and higher SctO 2  compared to propofol and remifentanil in patients having CABG. Administration of atropine might be useful to counteract or prevent the haemodynamic suppression associated with these opioids.
TRIAL REGISTRATION


Clinicaltrials.gov on June 7, 2013 (trial ID: NCT01871935 ).",2020,"The sufentanil group compared to the remifentanil group showed significantly less decrease in MAP (∆ = - 23 ± 13 vs. -36 ± 13 mmHg), HR (∆ = - 5 ± 7 vs. -10 ± 10 bpm), SV (∆ = - 23 ± 18 vs. -35 ± 19 ml) and CI (∆ = - 0.8 (- 1.5 to - 0.5) vs. -1.5 (- 2.0 to - 1.1)","['seventy patients scheduled for coronary bypass grafting (CABG), anaesthesia was induced and maintained with', 'patients having CABG']","['sufentanil', 'sufentanil vs. remifentanil', 'propofol and remifentanil', 'propofol-remifentanil', 'propofol-sufentanil', 'methylatropine', 'Atropine', 'remifentanil', 'propofol target controlled infusion (TCI) with a target effect-site concentration (Cet) of 2.0\u2009μg\u2009ml -\u20091  and either sufentanil (TCI Cet 0.48\u2009ng\u2009ml -\u20091 ) or remifentanil (TCI Cet 8', 'atropine']","['haemodynamic stability and cerebral tissue oxygenation', 'haemodynamic stability', 'higher ∆HR', '∆SptO 2  (∆', 'mean arterial pressure (MAP), heart rate (HR) and cardiac index (CI), raising concerns on tissue-oxygenation', 'MAP', 'Relative changes (∆) in MAP, HR, stroke volume (SV), CI and cerebral (SctO 2 ) and peripheral (SptO 2 ) tissue-oxygenation during induction of anaesthesia']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0066332', 'cui_str': 'methylatropine'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C4517461', 'cui_str': '0.48'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}]",70.0,0.204808,"The sufentanil group compared to the remifentanil group showed significantly less decrease in MAP (∆ = - 23 ± 13 vs. -36 ± 13 mmHg), HR (∆ = - 5 ± 7 vs. -10 ± 10 bpm), SV (∆ = - 23 ± 18 vs. -35 ± 19 ml) and CI (∆ = - 0.8 (- 1.5 to - 0.5) vs. -1.5 (- 2.0 to - 1.1)","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Poterman', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Groningen, Hanzeplein 1, PO Box 30 001, 9700, RB, Groningen, The Netherlands. mpoterman@gmail.com.'}, {'ForeName': 'Alain F', 'Initials': 'AF', 'LastName': 'Kalmar', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Groningen, Hanzeplein 1, PO Box 30 001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Pieter L', 'Initials': 'PL', 'LastName': 'Buisman', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Groningen, Hanzeplein 1, PO Box 30 001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Michel M R F', 'Initials': 'MMRF', 'LastName': 'Struys', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Groningen, Hanzeplein 1, PO Box 30 001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Thomas W L', 'Initials': 'TWL', 'LastName': 'Scheeren', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Groningen, Hanzeplein 1, PO Box 30 001, 9700, RB, Groningen, The Netherlands.'}]",BMC anesthesiology,['10.1186/s12871-020-01174-9']
2874,33028223,Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol.,"BACKGROUND


Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits.
METHODS


We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps.
CONCLUSION


If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints.
TRIAL REGISTRATION


The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.",2020,"We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial.","['surgical patients with frailty traits -OASIS', '120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm', 'Frail older surgical patients', 'patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial', 'older adults with frailty traits']","['Preoperative exercise', 'preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance', 'athletic trainer (AT']","['postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus', '6MWD) and mobility (postoperative steps', 'loss of stamina and mobility']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",120.0,0.251973,"We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial.","[{'ForeName': 'Laboni', 'Initials': 'L', 'LastName': 'Hoque', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dewolf', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meyers', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester, MA, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Stefan', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Alavi', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Maxfield', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Feiran', 'Initials': 'F', 'LastName': 'Lou', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Uy', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Walz', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'University of Massachusetts Medical School, 365 Plantation St, Worcester, MA, 01605, USA. alok.kapoor@umassmemorial.org.'}]",BMC geriatrics,['10.1186/s12877-020-01799-y']
2875,33028224,Clinical application of drug sensitive gene detection in postoperative instillation for non-muscle invasive bladder cancer.,"BACKGROUND


Bladder cancer is the most common malignant tumor of the urinary system. One of the biological characteristics of NMIBC is the high recurrence rate after surgery. The implementation of this project aimed to investigate the role of pharmacogenomic testing-guided intravesical perfusion of chemotherapeutic agents in the postoperative perfusion therapy for non-muscle invasive bladder cancer.
METHOD


From January 2015 to December 2016, 298 patients with non-muscle-invasive bladder cancer were enrolled in this prospective study. These patients received chemotherapy drugs after electrotherapy. According to the presence or absence of tumor susceptibility gene detection after surgery, they were divided into two groups, including the drug sensitive group(N = 44) and the control group(N = 254). The drug sensitive group received bladder infusion therapy with sensitive chemotherapy drugs based on drug sensitivity gene detection results. The control group received intravesical instillation of pirarubicin. The preoperative general data and tumor grade of patients were recorded. Cystoscopy was performed before and every 3 months after surgery. The chest CT, upper abdomen CT, renal function, and urinary routine tests were performed. Tumor recurrence, metastasis and tumor-related death were recorded and evaluated during follow-up.
RESULTS


The drug sensitive group, which selected high-sensitivity drugs for intravesical instillation therapy based on gene expression, has a significantly lower relapse rate (11.36% vs 37.40%, P < 0.05) and a significantly longer time to relapse (17.80 ± 7.20 month vs11.20 ± 6.10 month, P < 0.05) compared with the control group. There were no significant differences in the time of mortality and death time between two groups.
CONCLUSION


The pharmacogenomic testing-directed bladder instillation of chemotherapeutic drugs may be more effective than empiric drug administration in reducing the recurrence rate of non-muscle-invasive bladder cancer.",2020,"There were no significant differences in the time of mortality and death time between two groups.
","['non-muscle invasive bladder cancer', 'From January 2015 to December 2016, 298 patients with non-muscle-invasive bladder cancer']","['bladder infusion therapy', 'intravesical instillation of pirarubicin', 'chemotherapy drugs after electrotherapy']","['time of mortality and death time', 'chest CT, upper abdomen CT, renal function, and urinary routine tests', 'relapse rate', 'Tumor recurrence, metastasis and tumor-related death', 'time to relapse', 'recurrence rate']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0230165', 'cui_str': 'Upper abdomen (surface region)'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",298.0,0.019845,"There were no significant differences in the time of mortality and death time between two groups.
","[{'ForeName': 'Zhenlong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China.""}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China. hh1999@163.com.""}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Chong', 'Affiliation': ""Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, No.157 Xiwu Road, Xi'an, 710004, Shaanxi, China. chongtie@126.com.""}]",BMC nephrology,['10.1186/s12882-020-02073-4']
2876,33028236,MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial.,"BACKGROUND


Spasticity affects 60-80% of people with multiple sclerosis (MS), impacting activity, participation and quality of life. We developed the group delivered spasticity self-management program, ""MS Spasticity: Take Control"" (STC), with DVDs for education and lower extremity stretching. STC is based on an international guideline and recommendations from systematic reviews and emphasizes the importance of stretching with specific stretching exercises. Our pilot trial (n = 38) compared STC followed by one month of home stretching practice to unguided use of the National MS Society (NMSS) brochure titled ""Stretching for People with MS: An Illustrated Manual,"" also followed by one month of home stretching practice. In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures. We will now carry out a fully-powered trial to evaluate the effect of STC compared to a comparably delivered control program on the impact and severity of spasticity in people with MS and self-reported lower extremity spasticity.
METHODS


Two hundred-twenty ambulatory adults with MS self-reported spasticity interfering with daily activities will be randomized 1:1 to STC or control, using the same NMSS brochure used in the pilot study, with both programs delivered in groups with trained facilitators. Outcomes are the impact of spasticity with the MS Spasticity Scale-88, the severity of spasticity with the Numeric Rating Scale for Spasticity, other self-report questionnaires, and physical performance walking measures at baseline and one and 6 months after the interventions.
DISCUSSION


Stretching is the cornerstone of spasticity management. Stretching takes time and energy every day. Unfortunately, beyond the logical expectation that regular stretching should help prevent muscle shortening and contractures in the presence of spasticity, there is very little data on the effects of stretching on spasticity in people with MS or any other condition. Our pilot trial of STC suggested that education and stretching help reduce the impact of spasticity. To definitively determine if this education and instructional program with daily stretching practice is effective, a fully powered trial with a comparable control intervention and facilitators who did not create STC is needed. Here we report the protocol for this trial.
TRIAL REGISTRATION


NCT03166930 May 25, 2017.",2020,"In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures.","['Two hundred-twenty ambulatory adults with MS self-reported spasticity interfering with daily activities', 'people with MS and self-reported lower extremity spasticity', 'ambulatory adults']","['spasticity self-management program, ""MS Spasticity: Take Control"" (STC), with DVDs for education and lower extremity stretching', 'Control (STC', 'STC', 'STC or control, using the same NMSS brochure', 'National MS Society (NMSS) brochure titled ""Stretching for People with MS']","['spasticity with the MS Spasticity Scale-88, the severity of spasticity with the Numeric Rating Scale for Spasticity, other self-report questionnaires, and physical performance walking measures']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3834230', 'cui_str': 'Take Control'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",220.0,0.0480236,"In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures.","[{'ForeName': 'Cinda L', 'Initials': 'CL', 'LastName': 'Hugos', 'Affiliation': 'VA Portland Health Care System, 3710 SW US Veterans Hospital Rd. R&D 27, Portland, OR, 97239, USA. hugosc@ohsu.edu.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Cameron', 'Affiliation': 'VA Portland Health Care System, 3710 SW US Veterans Hospital Rd. R&D 27, Portland, OR, 97239, USA.'}]",BMC neurology,['10.1186/s12883-020-01902-1']
2877,33028243,BMC family practice integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial.,"BACKGROUND


Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.
METHODS


A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.
RESULTS


Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.
CONCLUSIONS


It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.
TRIAL REGISTRATION


NCT02444520  (ClinicalTrials.gov).",2020,Scores in GP knowledge and confidence increased post-training.,"['GP practices (clusters', 'Two thousand nine hundred seventy-eight patients were identified from 18 GP practices', '424 patients who responded with interest in the study, 164 fully met the eligibility criteria', 'Patients with PPS were recruited from participating GP practices before randomisation', 'patients with persistent physical symptoms', 'Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS', 'One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study', 'primary care, South London, UK']","['BMC family practice integrated GP care', ""integrated GP care plus treatment as usual' or 'treatment as usual"", 'GPs training']",['Retention rates'],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",2978.0,0.121128,Scores in GP knowledge and confidence increased post-training.,"[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'UK South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Maple House, UCL Institute of Mental Health, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Institute for Lifecourse Development, University of Greenwich, Old Royal Naval College, Park Row, Greenwich, London, SE10 9LS, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01269-9']
2878,33028256,"Modelling the lifetime cost-effectiveness of radical prostatectomy, radiotherapy and active monitoring for men with clinically localised prostate cancer from median 10-year outcomes in the ProtecT randomised trial.","BACKGROUND


Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups.
METHODS


A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L.
RESULTS


Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D'Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D'Amico and Grade group > = 2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D'Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings.
CONCLUSION


Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model.
TRIAL REGISTRATION


Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).",2020,"radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates.","['clinically localised prostate cancer', 'men with clinically localised prostate cancer from median 10-year outcomes']","['radical radiotherapy and prostatectomy', 'radical radiotherapy', 'radical prostatectomy, radiotherapy and active monitoring', 'three major treatments (radical radiotherapy, radical prostatectomy and active monitoring']",['lifetime cost-effectiveness'],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.195881,"radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sanghera', 'Affiliation': 'Health Economics Bristol (HEB), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK. Sabina.Sanghera@bristol.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mohiuddin', 'Affiliation': 'Health Economics Bristol (HEB), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Health Economics Bristol (HEB), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Health Economics Bristol (HEB), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Health Economics Bristol (HEB), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 7DQ, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'NIHR Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol, Bristol, BS1 2NT, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-07276-4']
2879,33028261,Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery.,"BACKGROUND


Pre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications.
METHODS


Electronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum. The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). Secondary outcomes will consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity. Post-natal outcomes will be duration of breastfeeding, maternal weight retention and child weight at postnatal visit.
DISCUSSION


The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.",2020,"A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum.","['860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22\u2009weeks of gestation', 'obese pregnant women', 'women at high risk of obstetric and neonatal complications', 'obese women in pregnancy']","['ePPOP-ID', 'electronic-personalized program', 'e-health web-based platform offering a personalized lifestyle program']","['consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity', 'duration of breastfeeding, maternal weight retention and child weight at postnatal visit', 'composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0242963', 'cui_str': 'Perinatal Care'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1261135', 'cui_str': 'Postnatal visit'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C1272612', 'cui_str': 'Vacuum extractor'}]",860.0,0.168622,"A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Deruelle', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France. pderuelle@unistra.fr.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lelorain', 'Affiliation': 'Univ. Lille, CNRS, CHU Lille, UMR 9193 - SCALab - Cognitive and Affective Sciences, Lille, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Deghilage', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Couturier', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Guilbert', 'Affiliation': 'Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Berveiller', 'Affiliation': 'Department of Obstetrics and Gynecology, Poissy Saint Germain hospital, Poissy, France.'}, {'ForeName': 'Marie Victoire', 'Initials': 'MV', 'LastName': 'Sénat', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Gynecology-Obstetrics, Bicêtre Hospital, University of Paris-Sud, University of Medicine Paris- Saclay Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Vayssière', 'Affiliation': 'Department of Obstetrics and Gynecology, Paule de Viguier Hospital, CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Sentilhes', 'Affiliation': 'Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Perrotin', 'Affiliation': 'Department of Gynecology and Obstetrics, Inserm U1253 « Imaging and Brain » (iBrain). CHU Bretonneau, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gallot', 'Affiliation': 'Pôle Femme Et Enfant, CHU Estaing, Clermont-Ferrand cedex 1, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chauleur', 'Affiliation': 'INSERM, SAINBIOSE, U1059, Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, CIC1408, F- 42055, Saint-Etienne, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sananes', 'Affiliation': 'Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Luton', 'Affiliation': 'Department of Obstetrics and Gynecology, AP-HP, Bichat hospital, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Department of Obstetrics and Gynecology, Lens general hospital, Lens, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lorio', 'Affiliation': 'Department of Obstetrics and Gynecology, Valenciennes general hospital, Valenciennes, France.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Chatelet', 'Affiliation': 'Department of Obstetrics and Gynecology, Béthune general hospital, Béthune, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Couster', 'Affiliation': 'Department of Obstetrics and Gynecology, Boulogne general hospital, Boulogne, France.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Timbely', 'Affiliation': 'Department of Obstetrics and Gynecology, Meaux general hospital, Meaux, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Doret-Dion', 'Affiliation': 'Department of obstetrics and gynecology surgery, Femme mere enfant university hospital, hospices civils de Lyon, Bron, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, EA 2694 - Santé publique : épidémiologie et qualité des soins, F-59000, Lille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Pigeyre', 'Affiliation': 'Department of medicine, endocrinology division, Mc Master university, Hamilton, Canada.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03288-x']
2880,33028293,Impact of reducing the duration of antibiotic treatment on the long-term prognosis of community acquired pneumonia.,"BACKGROUND


The optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) is not well established. The aim of this study was to assess the impact of reducing the duration of antibiotic treatment on long-term prognosis in patients hospitalized with CAP.
METHODS


This was a multicenter study assessing complications developed during 1 year of patients previously hospitalized with CAP who had been included in a randomized clinical trial concerning the duration of antibiotic treatment. Mortality at 90 days, at 180 days and at 1 year was analyzed, as well as new admissions and cardiovascular complications. A subanalysis was carried out in one of the hospitals by measuring C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM) at admission, at day 5 and at day 30.
RESULTS


A total of 312 patients were included, 150 in the control group and 162 in the intervention group. Ninety day, 180 day and 1-year mortality in the per-protocol analysis were 8 (2.57%), 10 (3.22%) and 14 (4.50%), respectively. There were no significant differences between both groups in terms of 1-year mortality (p = 0.94), new admissions (p = 0.84) or cardiovascular events (p = 0.33). No differences were observed between biomarker level differences from day 5 to day 30 (CRP p = 0.29; PCT p = 0.44; proADM p = 0.52).
CONCLUSIONS


Reducing antibiotic treatment in hospitalized patients with CAP based on clinical stability criteria is safe, without leading to a greater number of long-term complications.",2020,"There were no significant differences between both groups in terms of 1-year mortality (p = 0.94), new admissions (p = 0.84) or cardiovascular events (p = 0.33).","['hospitalized patients with CAP', 'community-acquired pneumonia (CAP', 'A total of 312 patients were included, 150 in the control group and 162 in the intervention group', 'community acquired pneumonia', 'patients hospitalized with CAP', 'patients previously hospitalized with CAP who had been included']",['antibiotic treatment'],"['Mortality', 'new admissions', 'biomarker level differences', '1-year mortality', 'C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM', 'cardiovascular events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0257634', 'cui_str': 'proadrenomedullin'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",312.0,0.0996884,"There were no significant differences between both groups in terms of 1-year mortality (p = 0.94), new admissions (p = 0.84) or cardiovascular events (p = 0.33).","[{'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Uranga Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Galdakao-Usansolo, Barrio Labeaga s/n, 48960, Galdakao, Bizkaia, Spain. ane.urangaecheverria@osakidetza.eus.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Artaraz Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Galdakao-Usansolo, Barrio Labeaga s/n, 48960, Galdakao, Bizkaia, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Bilbao Md', 'Affiliation': 'Research Unit, Osakidetza, Universitary Hospital of Basurto, Bilbao, Bizkaia, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Quintana Md', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Galdakao, Bizkaia, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Arriaga Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Basurto, Bilbao, Bizkaia, Spain.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Intxausti Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Basurto, Bilbao, Bizkaia, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lobo Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Alava, Vitoria, Alava, Spain.'}, {'ForeName': 'Julia Amaranta', 'Initials': 'JA', 'LastName': 'García Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Alava, Vitoria, Alava, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Camino Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Hospital of San Eloy, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Pedro Pablo', 'Initials': 'PP', 'LastName': 'España Md', 'Affiliation': 'Department of Pneumology, Osakidetza, Universitary Hospital of Galdakao-Usansolo, Barrio Labeaga s/n, 48960, Galdakao, Bizkaia, Spain.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01293-6']
2881,33028319,Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations.,"BACKGROUND


Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress.
METHODS


The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a 'healthy baby' composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born ""healthy"" in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional 'healthy and positive birth' of the intervention with standard care. Qualitative data will be analysed thematically.
DISCUSSION


This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers.
TRIAL REGISTRATION


Trial registration; ISRCTN, ISRCTN91977441 . Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.",2020,"BACKGROUND


Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS.","['diverse and disadvantaged women', 'Registered 11 February 2019 - retrospectively registered']",[],"['number of babies born ""healthy', ""healthy baby' composite measured at 1\u2009month postnatal using routine maternity data""]","[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",,0.168087,"BACKGROUND


Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS.","[{'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Wiggins', 'Affiliation': 'Social Research Institute, University College London, 27 Woburn Square, London, WC1H 0AA, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sawtell', 'Affiliation': 'Social Research Institute, University College London, 27 Woburn Square, London, WC1H 0AA, UK. m.sawtell@ucl.ac.uk.'}, {'ForeName': 'Octavia', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eldridge', 'Affiliation': 'Queen Mary University of London, Pragmatic Clinical Trials Unit, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Bordea', 'Affiliation': 'University College London, Institute of Clinical Trials & Methodology, London, UK.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Mustard', 'Affiliation': 'Queen Mary University of London, Pragmatic Clinical Trials Unit, London, UK.'}, {'ForeName': 'Ainul', 'Initials': 'A', 'LastName': 'Hanafiah', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Hatherall', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Holmes', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mehay', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Helliner', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Salisbury', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Kade', 'Initials': 'K', 'LastName': 'Mondeh', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Harden', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}]",BMC health services research,['10.1186/s12913-020-05751-z']
2882,33028335,Which behaviour change techniques are effective to promote physical activity and reduce sedentary behaviour in adults: a factorial randomized trial of an e- and m-health intervention.,"BACKGROUND


E- and m-health interventions are promising to change health behaviour. Many of these interventions use a large variety of behaviour change techniques (BCTs), but it's not known which BCTs or which combination of BCTs contribute to their efficacy. Therefore, this experimental study investigated the efficacy of three BCTs (i.e. action planning, coping planning and self-monitoring) and their combinations on physical activity (PA) and sedentary behaviour (SB) against a background set of other BCTs.
METHODS


In a 2 (action planning: present vs absent) × 2 (coping planning: present vs absent) × 2 (self-monitoring: present vs absent) factorial trial, 473 adults from the general population used the self-regulation based e- and m-health intervention 'MyPlan2.0' for five weeks. All combinations of BCTs were considered, resulting in eight groups. Participants selected their preferred target behaviour, either PA (n = 335, age = 35.8, 28.1% men) or SB (n = 138, age = 37.8, 37.7% men), and were then randomly allocated to the experimental groups. Levels of PA (MVPA in minutes/week) or SB (total sedentary time in hours/day) were assessed at baseline and post-intervention using self-reported questionnaires. Linear mixed-effect models were fitted to assess the impact of the different combinations of the BCTs on PA and SB.
RESULTS


First, overall efficacy of each BCT was examined. The delivery of self-monitoring increased PA (t = 2.735, p = 0.007) and reduced SB (t = - 2.573, p = 0.012) compared with no delivery of self-monitoring. Also, the delivery of coping planning increased PA (t = 2.302, p = 0.022) compared with no delivery of coping planning. Second, we investigated to what extent adding BCTs increased efficacy. Using the combination of the three BCTs was most effective to increase PA (x 2  = 8849, p = 0.003) whereas the combination of action planning and self-monitoring was most effective to decrease SB (x 2  = 3.918, p = 0.048). To increase PA, action planning was always more effective in combination with coping planning (x 2  = 5.590, p = 0.014; x 2  = 17.722, p < 0.001; x 2  = 4.552, p = 0.033) compared with using action planning without coping planning. Of note, the use of action planning alone reduced PA compared with using coping planning alone (x 2  = 4.389, p = 0.031) and self-monitoring alone (x 2  = 8.858, p = 003), respectively.
CONCLUSIONS


This study provides indications that different (combinations of) BCTs may be effective to promote PA and reduce SB. More experimental research to investigate the effectiveness of BCTs is needed, which can contribute to improved design and more effective e- and m-health interventions in the future.
TRIAL REGISTRATION


This study was preregistered as a clinical trial (ID number: NCT03274271 ). Release date: 20 October 2017.",2020,"The delivery of self-monitoring increased PA (t = 2.735, p = 0.007) and reduced SB (t = - 2.573, p = 0.012) compared with no delivery of self-monitoring.","['Participants selected their preferred target behaviour, either PA (n\xa0=\u2009335,\xa0age\u2009=\u200935.8,\xa028.1% men) or SB (n\xa0=\u2009138,\xa0age\u2009=\u200937.8,\xa037.7% men', 'adults', ""473 adults from the general population used the self-regulation based e- and m-health intervention 'MyPlan2.0' for five weeks""]","['e- and m-health intervention', '×\u20092 (coping planning']","['reduced SB', 'physical activity (PA) and sedentary behaviour (SB', 'Levels of PA (MVPA in minutes/week) or SB (total sedentary time']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",473.0,0.0290586,"The delivery of self-monitoring increased PA (t = 2.735, p = 0.007) and reduced SB (t = - 2.573, p = 0.012) compared with no delivery of self-monitoring.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Schroé', 'Affiliation': 'Ghent Health Psychology Lab, Department of Experimental-Clinical and Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Henri Dunantlaan 2, Ghent, 9000, Belgium. helene.schroe@ugent.be.'}, {'ForeName': 'Delfien', 'Initials': 'D', 'LastName': 'Van Dyck', 'Affiliation': 'Research Group Physical Activity and Health, Department of Movement and Sports Sciences, Faculty of Medicine and Health, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'De Paepe', 'Affiliation': 'Ghent Health Psychology Lab, Department of Experimental-Clinical and Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Henri Dunantlaan 2, Ghent, 9000, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Poppe', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Wen Wei', 'Initials': 'WW', 'LastName': 'Loh', 'Affiliation': 'Department of Data Analysis, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Loeys', 'Affiliation': 'Department of Data Analysis, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'De Bourdeaudhuij', 'Affiliation': 'Research Group Physical Activity and Health, Department of Movement and Sports Sciences, Faculty of Medicine and Health, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Ghent Health Psychology Lab, Department of Experimental-Clinical and Health Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Henri Dunantlaan 2, Ghent, 9000, Belgium.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01001-x']
2883,33028352,Effect of intermittent versus continuous calorie restriction on body weight and cardiometabolic risk markers in subjects with overweight or obesity and mild-to-moderate hypertriglyceridemia: a randomized trial.,"BACKGROUND


Intermittent calorie restriction (ICR) is a novel method of dietary restriction for body weight control with the potential to improve obesity-related cardiometabolic markers, but the impact of this diet on subjects with hypertriglyceridemia (HTG) remains unknown.
METHODS


Eighty-eight subjects with overweight or obesity and mild-to-moderate HTG were randomized to the continuous calorie restriction (CCR) group, or ICR group (a very low-calorie diet during 3 days of the week) for 8 weeks (44 patients in each group). Body composition, plasma lipids, glucose, insulin, adiponectin, and liver enzymes were measured at baseline and after 8 weeks. An intention-to-treat analysis was performed.
RESULTS


The body weight decreased in both groups (4.07 ± 1.83 kg in the CCR group and 4.57 ± 2.21 kg in the ICR group) with no significant difference between the groups. There was no significant difference between the two groups in the reduced amount of fat mass, fat-free mass, and waist circumference. Both groups achieved a significant reduction in plasma triglycerides after 8 weeks (by 15.6 and 6.3% in ICR and CCR groups, respectively) with no difference between treatment groups. HOMA-IR improved significantly in ICR compared to the CCR group (P = 0.03). Plasma glucose, insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, liver enzyme, and adiponectin were not different between the two groups.
CONCLUSIONS


The results of this short-term study suggest that three-days a week of the ICR is comparable to a CCR diet for the reduction of triglycerides level in patients with HTG and in the short-term it appears to be more effective than continuous dieting in improving insulin resistance. However, longer-term studies are needed to confirm these findings.
TRIAL REGISTRATION


Trial registration number: NCT04143971 .",2020,"There was no significant difference between the two groups in the reduced amount of fat mass, fat-free mass, and waist circumference.","['subjects with overweight or obesity and mild-to-moderate hypertriglyceridemia', 'subjects with hypertriglyceridemia (HTG', 'Eighty-eight subjects with overweight or obesity and mild-to-moderate HTG']","['calorie restriction (ICR', 'continuous calorie restriction', 'continuous calorie restriction (CCR) group, or ICR group (a very low-calorie diet']","['reduced amount of fat mass, fat-free mass, and waist circumference', 'plasma triglycerides', 'triglycerides level', 'HOMA-IR', 'Plasma glucose, insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, liver enzyme, and adiponectin', 'body weight and cardiometabolic risk markers', 'Body composition, plasma lipids, glucose, insulin, adiponectin, and liver enzymes', 'body weight', 'insulin resistance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C4517898', 'cui_str': '88'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",88.0,0.0588812,"There was no significant difference between the two groups in the reduced amount of fat mass, fat-free mass, and waist circumference.","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Maroofi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. jnasrollahzadeh@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01399-0']
2884,33024369,"Metabolic Resuscitation Using Hydrocortisone, Ascorbic Acid, and Thiamine: Do Individual Components Influence Reversal of Shock Independently?","Aims and objective


To study the effects of various components of ""metabolic resuscitation"" on the shock reversal among patients with septic shock.
Introduction


Sepsis is characterized by dysregulated host response to infection. Mitochondrial dysfunction which occurs early in sepsis is associated with multiorgan dysfunction. Therapies such as adequate resuscitation, early administration of antibiotics, and aggressive monitoring reduced mortality substantially but it still remains high for those with septic shock. Combination of vitamin C, hydrocortisone, and thiamine improved outcome in a retrospective study, but how effective is this therapy in isolation compared to combination has to be known before implementation.
Materials and methods


This study is single-center, prospective, randomized nonblinded trial done in septic shock patients admitted to the medical intensive care unit. Subjects were randomized to three groups of hydrocortisone (H), hydrocortisone, ascorbic acid (HA), hydrocortisone, ascorbic acid, thiamine (HAT). Following randomization, they received hydrocortisone 200 mg over 24 hours as infusion, intravenous ascorbic acid 1.5 g every 6 hours, thiamine 200 mg twice daily as allotted and continued till shock reversal or death. Primary outcome is time to shock reversal and secondary outcome is time to vasopressor dose reduction from hemodynamic SOFA score 4-3.
Results


Twenty seven subjects were randomized into 3 groups of 9 each, of which 17 (63%) patients met primary outcome and secondary outcome has been studied in 16 (59%) patients. Eight patients (29.5%) died and did not meet either outcome and two patients (7.5%) met secondary outcome but not primary outcome because of discharge to other hospital. There is no difference in time to shock reversal [mean, SD in H (7422, 8348), HA (2528, 3086), HAT (1860, 749),  p  value 0.17]. There is no difference in time to shock reversal from hemodynamic SOFA 4-3 [mean, SD in H (4935, 6406), HA (2310, 2515), HAT (1800, 1282),  p  value 0.35].
Conclusion


In patients with septic shock, there is no difference in time to shock reversal comparing individual components of metabolic resuscitation.
How to cite this article


Reddy PR, Samavedam S, Aluru N, Yelle S, Rajyalakshmi B. Metabolic Resuscitation Using Hydrocortisone, Ascorbic Acid, and Thiamine: Do Individual Components Influence Reversal of Shock Independently? Indian J Crit Care Med 2020;24(8):649-652.",2020,"There is no difference in time to shock reversal from hemodynamic SOFA 4-3 [mean, SD in H (4935, 6406), HA (2310, 2515), HAT (1800, 1282),  p  value 0.35].
","['patients with septic shock', 'septic shock patients admitted to the medical intensive care unit', 'Twenty seven subjects']","['metabolic resuscitation', 'hydrocortisone (H), hydrocortisone, ascorbic acid (HA), hydrocortisone, ascorbic acid, thiamine (HAT', 'vitamin C, hydrocortisone, and thiamine', 'hydrocortisone 200 mg over 24 hours as infusion, intravenous ascorbic acid', 'Hydrocortisone, Ascorbic Acid, and Thiamine']","['discharge to other hospital', 'time to shock reversal', 'time to shock reversal and secondary outcome is time to vasopressor dose reduction from hemodynamic SOFA score 4-3']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",27.0,0.279364,"There is no difference in time to shock reversal from hemodynamic SOFA 4-3 [mean, SD in H (4935, 6406), HA (2310, 2515), HAT (1800, 1282),  p  value 0.35].
","[{'ForeName': 'Paidi Ramakrishna', 'Initials': 'PR', 'LastName': 'Reddy', 'Affiliation': 'Department of Critical Care, Virinchi Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Samavedam', 'Affiliation': 'Department of Critical Care, Virinchi Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Narmada', 'Initials': 'N', 'LastName': 'Aluru', 'Affiliation': 'Department of Critical Care, Virinchi Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Yelle', 'Affiliation': 'Department of Critical Care, Virinchi Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Boggu', 'Initials': 'B', 'LastName': 'Rajyalakshmi', 'Affiliation': 'Department of Critical Care, Virinchi Hospital, Hyderabad, Telangana, India.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-23515']
2885,33024370,"Vitamin C Therapy for Routine Care in Septic Shock (ViCTOR) Trial: Effect of Intravenous Vitamin C, Thiamine, and Hydrocortisone Administration on Inpatient Mortality among Patients with Septic Shock.","Background


Sepsis remains a leading cause of death worldwide despite advances in management strategies. Preclinical and observational studies have found mortality benefit with high-dose vitamin C in sepsis. Our study aims to prospectively evaluate the effect of intravenous hydrocortisone, vitamin C [ascorbic acid (AA)], and thiamine (HAT) administration in reducing inpatient all-cause mortality among patients with septic shock.
Materials and methods


Our single-center, prospective, open-label, randomized controlled trial recruited patients with admitting diagnosis of septic shock and assigned eligible patients (1:1) into either intervention (HAT) or control group (routine). The HAT group received intravenous combination of vitamin C (1.5 g every 6 hours), thiamine (200 mg every 12 hours), and hydrocortisone (50 mg every 6 hours) within 6 hours of onset of septic shock admission. The treatment was continued for at least 4 days, in addition to the routine standard of care provided to the control group. Thiamine and hydrocortisone use in control arm was not restricted. Vitamin C levels were estimated at baseline and at the end of the 4 days of treatment for both groups. The primary outcome evaluated was mortality during inpatient stay.
Results


Among 90 patients enrolled, 88 patients completed the study protocol. The baseline characteristics between the HAT ( n  = 45) and the routine ( n  = 43) groups were comparable. The all-cause mortality in the HAT cohort was 57% (26/45) compared to 53% (23/43) in the routine care group ( p  = 0.4, OR 1.19, 95% CI 0.51-2.76). The time to reversal of septic shock was significantly lower in the HAT (34.58 ± 22.63 hours) in comparison to the routine care (45.42 ± 24.4 hours) ( p  = 0.03, mean difference -10.84, 95% CI -20.8 to -0.87). No significant difference was observed between the HAT and the routine care with respect to changes in sequential organ failure assessment (SOFA) scores at 72 hours (2.23 ± 2.4 vs 1.38 ± 3.1), the use of mechanical ventilation (48% vs 46%), and mean Vasoactive Inotropic Score (7.77 ± 12.12 vs 8.86 ± 12.5).
Conclusion


Intravenous administration of vitamin C, thiamine, and hydrocortisone did not significantly improve the inpatient all-cause mortality among patients with septic shock.
Clinical significance


HAT protocol does not reduce hospital mortality but decreases time to shock reversal in septic shock.
How to cite this article


Mohamed ZU, Prasannan P, Moni M, Edathadathil F, Prasanna P, Menon A,  et al.  Vitamin C Therapy for Routine Care in Septic Shock (ViCTOR) Trial: Effect of Intravenous Vitamin C, Thiamine, and Hydrocortisone Administration on Inpatient Mortality among Patients with Septic Shock. Indian J Crit Care Med 2020;24(8):653-661.",2020,"No significant difference was observed between the HAT and the routine care with respect to changes in sequential organ failure assessment (SOFA) scores at 72 hours (2.23 ± 2.4 vs 1.38 ± 3.1), the use of mechanical ventilation (48% vs 46%), and mean Vasoactive Inotropic Score (7.77 ± 12.12 vs 8.86 ± 12.5).
","['patients with septic shock', 'Septic Shock', 'patients with admitting diagnosis of septic shock and assigned eligible patients (1:1) into either', '90 patients enrolled, 88 patients completed the study protocol', 'Patients with Septic Shock']","['hydrocortisone, vitamin C [ascorbic acid (AA', 'Vitamin C Therapy', 'vitamin C, thiamine, and hydrocortisone', 'intravenous combination of vitamin C', 'thiamine', 'Intravenous Vitamin C, Thiamine, and Hydrocortisone Administration', 'thiamine (HAT', 'hydrocortisone', 'intervention (HAT) or control group (routine', 'vitamin C', 'Thiamine and hydrocortisone']","['mechanical ventilation', 'hospital mortality', 'mean Vasoactive Inotropic Score', 'sequential organ failure assessment (SOFA) scores', 'mortality during inpatient stay', 'Inpatient Mortality', 'time to reversal of septic shock', 'Vitamin C levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0332133', 'cui_str': 'Admitting diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0062773', 'cui_str': 'Histone acetyltransferase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.374856,"No significant difference was observed between the HAT and the routine care with respect to changes in sequential organ failure assessment (SOFA) scores at 72 hours (2.23 ± 2.4 vs 1.38 ± 3.1), the use of mechanical ventilation (48% vs 46%), and mean Vasoactive Inotropic Score (7.77 ± 12.12 vs 8.86 ± 12.5).
","[{'ForeName': 'Zubair U', 'Initials': 'ZU', 'LastName': 'Mohamed', 'Affiliation': 'Department of Anesthesia and Critical Care, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Prasannan', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Moni', 'Affiliation': 'Department of General Medicine and Division of Infectious Diseases, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Fabia', 'Initials': 'F', 'LastName': 'Edathadathil', 'Affiliation': 'Department of Allied Health Sciences, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Prasanna', 'Affiliation': 'Department of General Medicine and Division of Infectious Diseases, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Sabarish', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Department of Emergency Medicine, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Greeshma', 'Affiliation': 'Department of Biostatistics, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Dipu T', 'Initials': 'DT', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of General Medicine and Division of Infectious Diseases, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Clinical Virology Laboratory, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of General Medicine, Amrita Institute of Medical Sciences, Kochi, Kerala, India.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-23517']
2886,33024376,Comparison of Standard Conservative Treatment and Early Initiation of Renal Replacement Therapy in Pregnancy-related Acute Kidney Injury: A Single-center Prospective Study.,"Introduction and objective


Pregnancy-related acute kidney injury (PRAKI) is one of the most important cause of maternal and fetal morbidity and mortality. Some of the reasons behind PRAKI may be due to sepsis, postpartum hemorrhage, preeclampsia, thrombotic microangiopathies (TMA), and acute fatty liver of pregnancy (AFLP). The timing of initiation of renal replacement therapy (RRT) for better patient outcome is still debatable. We conducted this study to establish whether earlier initiation of RRT in PRAKI improves fetomaternal survival compared to a more conservative approach.
Materials and methods


This is a prospective study, where patients were screened at a multispecialty tertiary care hospital in north India for 1 year. The patients were divided into two groups: early RRT and standard AKI treatment. The demographic profile and clinical characteristics of the patients in terms of age, parity access to antenatal care, fetal outcome, urine output, hematological and biochemical profiles, RRT, duration of hospitalization, recovery of renal function, and patients survival were recorded.
Results


This prospective study conducted included 13 patients in the early RRT group and 23 patients in the standard group. Considering the fetal outcome, the number of fetal deaths in early RRT group were 14.29%, whereas for the standard group it was 85.71%. In all, 75% of early RRT group and 25% of standard group had normal term delivery. Probability test applied showed they were statistically significant. One maternal mortality was there in the standard group. The indices of maternal outcome in PRAKI patients were found to be statistically insignificant.
Conclusion


The planning of RRT whether early or late does not make a difference in maternal mortality or morbidity. The fetal outcome is significantly better for patients with early RRT than conservative treatment in PRAKI.
How to cite this article


Banerjee A, Mehrotra G. Comparison of Standard Conservative Treatment and Early Initiation of Renal Replacement Therapy in Pregnancy-related Acute Kidney Injury: A Single-center Prospective Study. Indian J Crit Care Med 2020;24(8):688-694.",2020,One maternal mortality was there in the standard group.,"['13 patients in the early RRT group and 23 patients in the standard group', 'Pregnancy-related Acute Kidney Injury', 'patients were screened at a multispecialty tertiary care hospital in north India for 1 year']","['renal replacement therapy (RRT', 'RRT and standard AKI treatment', 'Standard Conservative Treatment and Early Initiation of Renal Replacement Therapy']","['antenatal care, fetal outcome, urine output, hematological and biochemical profiles, RRT, duration of hospitalization, recovery of renal function, and patients survival', 'fetomaternal survival', 'normal term delivery', 'maternal mortality or morbidity', 'maternal mortality', 'number of fetal deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0233089', 'cui_str': 'Term pregnancy delivered'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0422806', 'cui_str': 'Number of fetal deaths'}]",,0.0494955,One maternal mortality was there in the standard group.,"[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Department of Anesthesia and Critical Care, Asian Vivekanand Super Speciality Hospital, Moradabad, Uttar Pradesh, India.'}, {'ForeName': 'Gesu', 'Initials': 'G', 'LastName': 'Mehrotra', 'Affiliation': 'Department of Anesthesiology and Critical Care, Siddh Multispecialty Hospital, Moradabad, Uttar Pradesh, India.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-23537']
2887,33024379,Effects of Sedation and/or Sedation/Analgesic Drugs Administered during Central Venous Catheterization on the Level of End-tidal Carbon Dioxide Measured by Nasal Cannula in Our PICU.,"Aims and objectives


Sedatives and analgesics are commonly used in pediatric intensive care units during minor invasive procedures. Here, we aimed to measure the changes in end-tidal carbon dioxide (EtCO 2 ) levels with different sedation/analgesic drug administrations (midazolam, ketamine, midazolam + ketamine/fentanyl) during central venous catheterization.
Materials and methods


This prospective study included 44 patients who needed sedation/analgesia for central venous catheterization. Patients were sedated with midazolam, ketamine, or midazolam + fentanyl/ketamine. End-tidal carbon dioxide values were measured before and after sedation-analgesia with nasal cannula and recorded from the capnograph. Oxygen saturation (SO 2 ) was monitored by pulse oximetry. Whether respiratory depression occurred during the process was recorded.
Results


During the procedure, 15 (34%) patients were given 0.1 mg/kg dose of midazolam described as group I, 18 (41%) patients were given 1 mg/kg dose of ketamine only described as group II, and 11 (25%) patients who could not be effective sedated with a single sedative-analgesic agent were given either 1 mg/kg dose of ketamine or 2 μg/kg dose of fentanyl together with 0.1 mg/kg dose of midazolam described as group III. According to our findings, hypoxia (54.5%) and hypercarbia (45.5%) were detected higher in group III but it was not statistically significant ( p  = 0.255,  p  = 0.364). Hypercarbia was detected in 29.5% patients, in 62% of these patients hypercarbia was accompanied by hypoxia, and 38% had only hypercarbia. When presedation and postsedation EtCO 2  values were compared, we detected a statistically significant difference in all groups.
Conclusion


We detected hypercarbia unaccompanied by hypoxemia in 38% patients. And we think that we have identified these patients early due to measurement of EtCO 2  by nasal cannula. This study demonstrated that EtCO 2  monitoring via nasal cannula is a feasible and practical way to follow ventilation during sedation/analgesia.
How to cite this article


Aslan N, Yildizdas D, Horoz OO, Arslan D, Coban Y, Sertdemir Y. Effects of Sedation and/or Sedation/Analgesic Drugs Administered during Central Venous Catheterization on the Level of End-tidal Carbon Dioxide Measured by Nasal Cannula in Our PICU. Indian J Crit Care Med 2020;24(8):705-708.",2020,"During the procedure, 15 (34%) patients were given 0.1 mg/kg dose of midazolam described as group","['44 patients who needed sedation/analgesia for central venous catheterization', 'pediatric intensive care units during minor invasive procedures']","['ketamine', 'ketamine or 2 μg/kg dose of fentanyl together with 0.1 mg/kg dose of midazolam', 'midazolam, ketamine, or midazolam + fentanyl/ketamine', 'Sedation and/or Sedation/Analgesic Drugs', 'midazolam', 'midazolam, ketamine, midazolam + ketamine/fentanyl']","['Level of End-tidal Carbon Dioxide', 'hypercarbia', 'Hypercarbia', 'Oxygen saturation (SO 2 ', 'changes in end-tidal carbon dioxide (EtCO 2 ) levels', 'respiratory depression', 'End-tidal carbon dioxide values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",44.0,0.0619291,"During the procedure, 15 (34%) patients were given 0.1 mg/kg dose of midazolam described as group","[{'ForeName': 'Nagehan', 'Initials': 'N', 'LastName': 'Aslan', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Dincer', 'Initials': 'D', 'LastName': 'Yildizdas', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Ozden Ozgur', 'Initials': 'OO', 'LastName': 'Horoz', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Didar', 'Initials': 'D', 'LastName': 'Arslan', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Coban', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Sertdemir', 'Affiliation': 'Department Pediatric Intensive Care, Faculty of Medicine, Çukurova University, Adana, Turkey; Department of Biostatistics, Cukurova University Faculty of Medicine, Çukurova University, Adana, Turkey.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-23529']
2888,33024467,"High-power, short-duration ablation during Box isolation for atrial fibrillation.","Background


It has been demonstrated that a high-power, short-duration (HPSD) ablation during pulmonary vein (PV) isolation is effective and safe. However, studies about the HPSD ablation during the posterior wall isolation, the Box isolation (BOXI), are limited. We evaluated the efficacy, feasibility, and safety of HPSD ablation during BOXI.
Methods


One-hundred sixty patients with all types of atrial fibrillation underwent BOXI with HPSD ablation (n = 80) or conventional technique (n = 80). In the HPSD group, ablation was performed with 50 W and a target lesion size index of 5.0 using a contact force (CF) sensing catheter. Ablation near the esophagus was performed with 50 W for 5 seconds and a CF < 10 g. In the conventional group, ablation was performed with 30-40 W for 30 seconds, but 20 W near the esophagus.
Results


The BOXI creation (26 ± 8 minutes vs 47 ± 17 minutes,  P  < .0001) and procedure (65 ± 12 minutes vs 87 ± 23 minutes,  P  < .0001) times were significantly shorter in the HPSD group than the conventional group. The number of pacing capture sites did not differ between the two groups. No complications including gastrointestinal symptoms occurred. The atrial tachyarrhythmia-free rate at 12-months after a single procedure was 86.3% in the HPSD group and 76.3% in the conventional group, respectively ( P  = .132). The incidence of PV reconnections and gaps in the lines during the second procedure did not differ between the two groups.
Conclusion


The BOXI with HPSD ablation is effective, feasible, and safe with short BOXI creation and procedure times without reducing the clinical outcomes.",2020,"The incidence of PV reconnections and gaps in the lines during the second procedure did not differ between the two groups.
",['One-hundred sixty patients with all types of atrial fibrillation underwent'],"['BOXI with HPSD ablation', 'conventional technique', 'HPSD', 'HPSD ablation']","['gastrointestinal symptoms', 'number of pacing capture sites', 'atrial tachyarrhythmia-free rate', 'efficacy, feasibility, and safety of HPSD ablation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",160.0,0.0340109,"The incidence of PV reconnections and gaps in the lines during the second procedure did not differ between the two groups.
","[{'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Heart Rhythm Center Fukuoka Sanno Hospital International University of Health and Welfare Fukuoka Japan.'}, {'ForeName': 'Hideko', 'Initials': 'H', 'LastName': 'Toyama', 'Affiliation': 'Heart Rhythm Center Fukuoka Sanno Hospital International University of Health and Welfare Fukuoka Japan.'}]",Journal of arrhythmia,['10.1002/joa3.12407']
2889,33024552,Green tea influence on iron overload in thalassemia intermedia patients: a randomized controlled trial.,"Background:  Although iron chelation therapies have been available for many years for thalassemia intermedia patients, iron accumulation remains the major cause of death. Therefore, the need for additional chelation options is in demand. This randomized controlled study aimed to understand the effects of green tea on iron balance in thalassemia intermedia patients.  Methods:  Using a random selection method, 141 thalassemia intermedia patients were initially screened for inclusion in this trial; only 68 patients included after applying exclusion criteria. Two equal groups were generated (n=34/group): green tea (three cups/day after meals) + usual treatment (deferasirox iron chelator and on demand blood transfusion); and control (only usual treatment). The study lasted for a period of 12 months. Patients failing to comply to the trial methodology were excluded, leaving a final total of 29 patients in the green tea group and 28 patients in the control group. Liver iron concentration, and serum ferritin were assessed at baseline and 12 months, while hemoglobin levels were assessed monthly.  Results:  At baseline, both groups were matched regarding general demographics. At 12 months, the net drop of liver iron concentration in the green tea group (7.3 mg Fe/g dry weight) was significantly higher than the control group (4.6 mg Fe/g dry weight) (p<0.05). This was also seen with serum ferritin; net reduction in green tea and control groups were 1289 ng/ml and 871 ng/ml, respectively (p<0.05). Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant.  Conclusions:  Regular green tea consumption had a significant capability to improve iron deposition in thalassemia intermedia patients who already undergo deferesirox iron chelation therapy.  Trial registration:  UMIN-CTR Clinical Trials Registry, UMIN000040841 (retrospectively registered June 21, 2020).",2020,"Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant.  ","['Patients failing to comply to the trial methodology were excluded, leaving a final total of 29 patients in the green tea group and 28 patients in the control group', 'thalassemia intermedia patients who already undergo deferesirox iron chelation therapy', '141 thalassemia intermedia patients were initially screened for inclusion in this trial; only 68 patients included after applying exclusion criteria', 'thalassemia intermedia patients']","['Green tea', 'Regular green tea consumption', 'green tea (three cups/day after meals) + usual treatment (deferasirox iron chelator and on demand blood transfusion); and control (only usual treatment', 'green tea']","['hemoglobin levels', 'Hemoglobin levels', 'liver iron concentration', 'iron deposition', 'serum ferritin; net reduction', 'Liver iron concentration, and serum ferritin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0271979', 'cui_str': 'Thalassemia intermedia'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0333596', 'cui_str': 'Deposition of iron'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.174387,"Hemoglobin levels were slightly higher in the green tea group compared with the control group, but this was not significant.  ","[{'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Al-Momen', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Hussein Khudhair', 'Initials': 'HK', 'LastName': 'Hussein', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Attar', 'Affiliation': 'Department of Pharmacology, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}, {'ForeName': 'Mohammed Jalal', 'Initials': 'MJ', 'LastName': 'Hussein', 'Affiliation': 'Department of Pediatrics, Al-Kindy College of Medicine, University of Baghdad, Baghdad, 00964, Iraq.'}]",F1000Research,['10.12688/f1000research.25553.1']
2890,33024556,Laparoscopic versus open mesh repair of bilateral primary inguinal hernia: A three-armed Randomized controlled trial.,"Purpose


The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia.
Methods


this prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair.
Results


In comparison to open PP and bilateral Lichtenstein repair, Laparoscopic TAPP repair had significantly longer operative time and superior early postoperative outcomes including significantly less postoperative pain, hospital stay, time till return to normal activity and to work. Chronic groin pain and mesh sensation was lower in Laparoscopic TAPP group with significantly higher satisfaction rate compared to open groups. No significant difference between study groups in 3 years recurrence rate.
Conclusion


Simultaneous laparoscopic TAPP repair of uncomplicated primary bilateral inguinal hernia has superior early postoperative outcome, less chronic pain and higher patients' satisfaction rate compared to open approaches with similar low recurrence rate.",2020,Chronic groin pain and mesh sensation was lower in Laparoscopic TAPP group with significantly higher satisfaction rate compared to open groups.,['180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients'],"['Laparoscopic versus open mesh repair of bilateral primary inguinal hernia', 'laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair', 'Laparoscopic TAPP', 'laparoscopic versus open mesh repair of bilateral primary inguinal hernia', 'bilateral Lichtenstein repair, Laparoscopic TAPP repair']","['operative time and superior early postoperative outcomes', 'postoperative pain, hospital stay, time till return to normal activity and to work', 'satisfaction rate', 'chronic pain', 'Chronic groin pain and mesh sensation', 'recurrence rate']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",180.0,0.211965,Chronic groin pain and mesh sensation was lower in Laparoscopic TAPP group with significantly higher satisfaction rate compared to open groups.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Elmessiry', 'Affiliation': 'Department of Surgery, Alexandria Faculty of Medicine, Alexandria, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gebaly', 'Affiliation': 'Department of Surgery, Alexandria Faculty of Medicine, Alexandria, Egypt.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2020.08.055']
2891,33024564,Flywheel squats versus free weight high load squats for improving high velocity movements in football. A randomized controlled trial.,"Background


High load (HL: > 85% of one repetition maximum (1RM)) squats with maximal intended velocity contractions (MIVC) combined with football sessions can be considered a relevant and time-efficient practice for maintaining and improving high velocity movements in football. Flywheel (FW) resistance exercise (RE) have recently emerged with promising results on physical parameters associated with football performance.
Methods


In this randomized controlled trial over 6 weeks, 38 recreationally active male football players randomly performed RE with MIVCs two times per week as either 1) FW squats ( n  = 13) or 2) barbell free weight (BFW) HL squats ( n  = 13), where a third group served as controls ( n  = 12). All three groups conducted 2-3 football sessions and one friendly match a week during the intervention period. Pre- to post changes in 10-m sprint, countermovement jump (CMJ) and 1RM partial squat were assessed with univariate analyses of variance.
Results


The FW and BFW group equally improved their 10-m sprint time (2 and 2%, respectively, within group: both  p  < 0.001) and jump height (9 and 8%, respectively, within group: both  p  < 0.001), which was superior to the control group's change (between groups: both  p  < 0.001). The BFW group experienced a larger increase (46%) in maximal squat strength than the FW group (17%, between groups:  p  < 0.001), which both were higher than the control group's change (both  p  < 0.001).
Conclusion


Squats carried out with FWs or BFWs where both are performed with MIVCs and combined with football sessions, were equally effective in improving sprint time and jump height in football players. The BFW group experienced a more than two-fold larger increase in maximal partial squat strength than the FW group in maximal partial squat strength. This presents FW RE as an alternative to BFW HL RE for improving high velocity movements in football.
Trial registration


ClinicalTrials.gov Identifier: NCT04113031 (retrospectively registered, date: 02.10.2019).",2020,The BFW group experienced a more than two-fold larger increase in maximal partial squat strength than the FW group in maximal partial squat strength.,['38 recreationally active male football players randomly performed'],"['Flywheel (FW) resistance exercise (RE', 'RE with MIVCs two times per week as either 1) FW squats ( n \u2009=\u200913) or 2) barbell free weight (BFW) HL squats', '\n\n\nHigh load (HL: >\u200985% of one repetition maximum (1RM)) squats with maximal intended velocity contractions (MIVC) combined with football sessions']","['10-m sprint, countermovement jump (CMJ) and 1RM partial squat', 'maximal squat strength', 'maximal partial squat strength', 'sprint time and jump height', '10-m sprint time', 'jump height']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0487168,The BFW group experienced a more than two-fold larger increase in maximal partial squat strength than the FW group in maximal partial squat strength.,"[{'ForeName': 'Edvard H', 'Initials': 'EH', 'LastName': 'Sagelv', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Pedersen', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Lars Petter R', 'Initials': 'LPR', 'LastName': 'Nilsen', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Casolo', 'Affiliation': ""Department of Movement, Human and Health Sciences, University of Rome 'Foro Italico', Rome, Italy.""}, {'ForeName': 'Boye', 'Initials': 'B', 'LastName': 'Welde', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Randers', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Svein Arne', 'Initials': 'SA', 'LastName': 'Pettersen', 'Affiliation': 'School of Sport Sciences, Faculty of Health Sciences, UiT the Arctic University of Norway, Tromsø, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00210-y']
2892,33024571,The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability.,"Background


Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS.
Methods


This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial.
Discussion


The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field.
Trial registration


ISRCTN70419473.",2020,The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children.,"['family caregivers of young children with intellectual disability', '64 families with a child (18\u2009months to 5\u2009years) with intellectual disability at research sites in the UK', 'family caregivers of children with intellectual disability by community parenting support service provider organisations', 'family caregivers of young children (5\u2009years and under) with intellectual and developmental disabilities']","['Support (E-PAtS) programme', 'group programme (E-PAtS', 'E-PAtS', 'E-PAtS intervention', 'E-PAtS.\nMethods']",['parental psychosocial wellbeing'],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.168939,The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children.,"[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hastings', 'Affiliation': 'Centre for Educational Development Appraisal and Research, University of Warwick, Coventry, CV4 7AL UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Gore', 'Affiliation': 'Tizard Centre, University of Kent, Cornwallis North East, Canterbury, CT2 7NF UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'DECIPHer Centre Cardiff University, 1-3 Museum Place, Cardiff, CF10 3BD UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bradshaw', 'Affiliation': 'Tizard Centre, University of Kent, Cornwallis North East, Canterbury, CT2 7NF UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jahoda', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, G12 8RZ, Glasgow, UK.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Lindsay', 'Affiliation': 'Centre for Educational Development Appraisal and Research, University of Warwick, Coventry, CV4 7AL UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lugg-Widger', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Shurlock', 'Affiliation': 'The Challenging Behaviour Foundation, The Old Courthouse, New Road Avenue, Chatham, Kent, ME4 6BE UK.'}, {'ForeName': 'Vaso', 'Initials': 'V', 'LastName': 'Totsika', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Wing B, Maple House, Tottenham Court Road, London, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00689-9']
2893,33024721,"A randomized clinical trial of metacognitive therapy and nortriptyline for anxiety, depression, and difficulties in emotion regulation of patients with functional dyspepsia.","Functional Dyspepsia (FD) as a psychosomatic disorder is an upper gastrointestinal tract disease without organic pathogenesis causes. The psychopathological nature of this disease and its high correlation with anxiety and depression implies the need for psychological interventions. The purpose of the present study is to compare the efficacy of Metacognitive Therapy (MCT) and medication for the symptoms of anxiety, depression, and difficulties in emotion regulation in patients with FD. In a randomized clinical trial, 65 patients with FD were recruited during their visit to gastroenterology clinics. These patients were randomly assigned to three groups to receive MCT, nortriptyline treatment, and controls. They were treated for 10 weeks and followed up three months later. The instruments used in this study were Hamilton anxiety and Depression Rating Scale (HAM-A and HDRS) and difficulties in emotion regulation scale. The results were analyzed using repeated measure analysis by SPSS (19- IBM). Data analysis showed statistically significant differences in the variables of depression, anxiety among MCT, nortriptyline treatment, and controls at pre-test, post-test and follow-up phases. Moreover, MCT had a better and more persistent effect on anxiety compared to nortriptyline treatment, as well as a better efficacy in treating anxiety and depression symptoms compared to the controls. MCT demonstrated better efficacy in treating anxiety symptoms compared to nortriptyline treatment and controls.",2020,"Data analysis showed statistically significant differences in the variables of depression, anxiety among MCT, nortriptyline treatment, and controls at pre-test, post-test and follow-up phases.","['patients with functional dyspepsia', 'patients with FD', '65 patients with FD were recruited during their visit to gastroenterology clinics']","['Metacognitive Therapy (MCT', 'metacognitive therapy and nortriptyline', 'MCT', 'MCT, nortriptyline', 'nortriptyline']","['anxiety symptoms', 'Functional Dyspepsia (FD', 'Hamilton anxiety and Depression Rating Scale (HAM-A and HDRS) and difficulties in emotion regulation scale', 'anxiety and depression symptoms', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",65.0,0.0341789,"Data analysis showed statistically significant differences in the variables of depression, anxiety among MCT, nortriptyline treatment, and controls at pre-test, post-test and follow-up phases.","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Batebi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Masjedi Arani', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases. Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saberi Isfeedvajani', 'Affiliation': 'Medicine, Quran and Hadith Research Center & Department of Community Medicine, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Davazdah Emami', 'Affiliation': 'Department of Health Psychology, Isfahan University of Medical Science, Isfahan, Iran.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2020.448']
2894,33024757,Effects of different doses of metformin on bone mineral density and bone metabolism in elderly male patients with type 2 diabetes mellitus.,"BACKGROUND


Diabetes is a chronic disease, which may cause various complications. Patients with diabetes are at high risk of bone and joint disorders, such as osteoporosis and bone fractures. In addition, it became widely accepted that diabetes has an important impact on bone metabolism. Metformin is a commonly used and effective first-line treatment for type 2 diabetes. Some glucose-lowering agents have been found to have an effect on bone metabolism. The present study explored if different doses of metformin have an effect on bone mineral density (BMD) and bone metabolism in type 2 diabetes.
AIM


To investigate the effects of different doses of metformin on BMD and bone metabolism in elderly male patients with type 2 diabetes mellitus.
METHODS


A total of 120 elderly male outpatients with type 2 diabetes mellitus who were admitted to our hospital were included in the study from July 2018 to June 2019. They were randomly assigned to an experimental group and a control group with 60 patients in each group. Patients in the experimental group were given high dose metformin four times a day 0.5 g each time for 12 wk. Patients in the control group were given low dose metformin orally twice a day 0.5 g each time for 12 wk. The changes in bone mineral density and bone metabolism before and after treatment and the efficacy rate of the treatment were compared between the two groups.
RESULTS


There was no significant difference in the efficacy rate between the two groups ( P  > 0.05). Before the treatment, there was no significant difference in BMD and bone metabolism between the two groups ( P  > 0.05). However, after the treatment, BMD and bone metabolism were improved in the two groups. Moreover, BMD and 25-hydroxyvitamin D were significantly higher in the experimental group than in the control group, and N-terminal/midregion and β-isomerized C-terminal telopeptides were significantly lower in the experimental group than in the control group (all  P  < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups ( P  > 0.05).
CONCLUSION


Both high and low dose metformin can effectively control the blood glucose levels in elderly male patients with type 2 diabetes mellitus. However, the benefits of high dose metformin in improving BMD and bone metabolism level was more obvious in patients with type 2 diabetes mellitus.",2020,"Moreover, BMD and 25-hydroxyvitamin D were significantly higher in the experimental group than in the control group, and N-terminal/midregion and β-isomerized C-terminal telopeptides were significantly lower in the experimental group than in the control group (all  P  < 0.05).","['patients with type 2 diabetes mellitus', 'elderly male patients with type 2 diabetes mellitus', 'type 2 diabetes', 'Patients with diabetes are at high risk of bone and joint disorders, such as osteoporosis and bone fractures', '120 elderly male outpatients with type 2 diabetes mellitus who were admitted to our hospital were included in the study from July 2018 to June 2019']","['metformin', 'Metformin']","['BMD and bone metabolism', 'BMD and 25-hydroxyvitamin D', 'efficacy rate', 'blood glucose levels', 'incidence of adverse reactions', 'bone mineral density (BMD) and bone metabolism', 'BMD and bone metabolism level', 'bone mineral density and bone metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",120.0,0.0222038,"Moreover, BMD and 25-hydroxyvitamin D were significantly higher in the experimental group than in the control group, and N-terminal/midregion and β-isomerized C-terminal telopeptides were significantly lower in the experimental group than in the control group (all  P  < 0.05).","[{'ForeName': 'Lin-Xia', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Guang-Ya', 'Initials': 'GY', 'LastName': 'Wang', 'Affiliation': 'Second Department of Endocrinology, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Su', 'Affiliation': 'Second Department of Endocrinology, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Second Department of Endocrinology, Cangzhou Central Hospital, Cangzhou 061001, Hebei Province, China.'}, {'ForeName': 'Yu-Kun', 'Initials': 'YK', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i18.4010']
2895,33024762,Intratympanic dexamethasone injection for sudden sensorineural hearing loss in pregnancy.,"BACKGROUND


As sudden sensorineural hearing loss (SSNHL) rarely occurs in pregnant women, there is a lack of knowledge and relevant research on its management.
AIM


To investigate the effect of intratympanic dexamethasone injection in the treatment of pregnant patients with SSNHL.
METHODS


A retrospective chart review was made for the period between June 2017 and August 2019 at our Department of Otorhinolaryngology-Head and Neck Surgery. Pregnant women who met the criteria for SSNHL were included and grouped based on the therapeutic modalities. The treatment group received intratympanic dexamethasone (2.5 mg) q.o.d. for a total of four times, while the control group received no medication other than bed rest and medical observations. All the patients were under close care of obstetricians. Pure-tone audiograms were performed before and after treatment.
RESULTS


Eleven patients who met the inclusion criteria were assigned to the treatment group ( n  = 7) and the control group ( n  = 4). The mean age of patients was 31.2 ± 3.8 years; the right ear was affected in seven (63.64%) cases. Two patients (18.2%) suffered from vertigo, 10 (90.9%) suffered from tinnitus and 6 (54.5%) suffered from aural fullness. The time from onset to clinic visit was relatively short, with a mean time of 1.3 ± 0.9 d. All the women were within the second or third trimester; the average gestation period was 26.0 ± 6.2 wk. The pure-tone averages at onset between the two groups were similar. After one wk of therapy, the treatment group had a curative rate of 57.1% and a significantly better hearing threshold and greater improvement compared to the control group (all  P  < 0.05). Some patients experienced transient discomfort from intratympanic injections that disappeared after getting rest, while none had permanent complications. All patients delivered healthy full-term neonates with an average Apgar score of 9.7 ± 0.5.
CONCLUSION


Intratympanic dexamethasone injections can be used as a first-line therapy in pregnant women with SSNHL.",2020,"After one wk of therapy, the treatment group had a curative rate of 57.1% and a significantly better hearing threshold and greater improvement compared to the control group (all  P  < 0.05).","['All patients delivered healthy full-term neonates with an average Apgar score of 9.7 ± 0.5', 'pregnant women', 'period between June 2017 and August 2019 at our Department of Otorhinolaryngology-Head and Neck Surgery', 'sudden sensorineural hearing loss in pregnancy', 'Eleven patients who met the inclusion criteria', 'Pregnant women who met the criteria for SSNHL were included and grouped based on the therapeutic modalities', 'pregnant patients with SSNHL', 'pregnant women with SSNHL']","['Intratympanic dexamethasone injection', 'intratympanic dexamethasone injection', 'control group received no medication other than bed rest and medical observations', 'Intratympanic dexamethasone injections', 'intratympanic dexamethasone']","['permanent complications', 'curative rate', 'hearing threshold', 'transient discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0948564', 'cui_str': 'Medical observation'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",11.0,0.0337102,"After one wk of therapy, the treatment group had a curative rate of 57.1% and a significantly better hearing threshold and greater improvement compared to the control group (all  P  < 0.05).","[{'ForeName': 'Yan-Lu', 'Initials': 'YL', 'LastName': 'Lyu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Fan-Qian', 'Initials': 'FQ', 'LastName': 'Zeng', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China.""}, {'ForeName': 'Zhao-Yang', 'Initials': 'ZY', 'LastName': 'Ke', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China. szrmebh@outlook.com.""}]",World journal of clinical cases,['10.12998/wjcc.v8.i18.4051']
2896,33024763,Research on the effect of health care integration on patients' negative emotions and satisfaction with lung cancer nursing activities.,"BACKGROUND


Lung cancer is a clinical disease with multiple malignant tumors. Currently, it is difficult for patients to benefit from routine clinical nursing due to the lack of a pertinent and systematic approach.
AIM


To investigate the effect of integrated nursing care on the negative emotions and satisfaction of lung cancer patients.
METHODS


From January 2018 to December 2019, 92 patients with lung cancer were selected and divided into the study group and the control group; there were 46 patients in each group. The control group received routine nursing, and the study group received integrated medical care in addition to the care received by the control group. Negative emotions before and after the intervention, the self-management ability score after the intervention, family care burden after the intervention and nursing satisfaction after the intervention were measured in the two groups.
RESULTS


After the intervention, the self-rating anxiety scale and self-rating depression scale scores in the study group were lower than those in the control group ( P  < 0.05); the scores for health knowledge, self-concept, self-responsibility and self-care skills in the study group were higher than those in the control group ( P  < 0.05); the scores for individual burden and responsibility burden in the study group were lower than those before the intervention ( P  < 0.05); and the nursing satisfaction in the study group (93.48%) was higher than that in the control group (78.26%,  P  < 0.05).
CONCLUSION


An integrated nursing care approach for lung cancer patients can effectively relieve the patient's negative feelings, improve their self-management ability, help to reduce the burden of family care and improve patient satisfaction with nursing activities.",2020,"After the intervention, the self-rating anxiety scale and self-rating depression scale scores in the study group were lower than those in the control group ( P  < 0.05); the scores for health knowledge, self-concept, self-responsibility and self-care skills in the study group were higher than those in the control group ( P  < 0.05); the scores for individual burden and responsibility burden in the study group were lower than those before the intervention ( P  < 0.05); and the nursing satisfaction in the study group (93.48%) was higher than that in the control group (78.26%,  P  < 0.05).
","['From January 2018 to December 2019, 92 patients with lung cancer', ""patients' negative emotions and satisfaction with lung cancer nursing activities"", 'lung cancer patients']","['health care integration', 'routine nursing, and the study group received integrated medical care in addition to the care received by the control group', 'integrated nursing care']","['self-rating anxiety scale and self-rating depression scale scores', 'nursing satisfaction', 'scores for health knowledge, self-concept, self-responsibility and self-care skills', 'Negative emotions', 'individual burden and responsibility burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",92.0,0.0187345,"After the intervention, the self-rating anxiety scale and self-rating depression scale scores in the study group were lower than those in the control group ( P  < 0.05); the scores for health knowledge, self-concept, self-responsibility and self-care skills in the study group were higher than those in the control group ( P  < 0.05); the scores for individual burden and responsibility burden in the study group were lower than those before the intervention ( P  < 0.05); and the nursing satisfaction in the study group (93.48%) was higher than that in the control group (78.26%,  P  < 0.05).
","[{'ForeName': 'Feng-Jiao', 'Initials': 'FJ', 'LastName': 'Long', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Yue-Feng', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology, Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Lan-Man', 'Initials': 'LM', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Zi-Bin', 'Initials': 'ZB', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Yan-Ni', 'Initials': 'YN', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology, Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology, the Cancer Center of the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China. g13926927855@163.com.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i18.4059']
2897,33025006,Lysine Bioavailability in School-Age Children Consuming Rice Is Reduced by Starch Retrogradation.,"BACKGROUND


Rice is one of the most commonly consumed cereal grains and is part of staple diets in the majority of the world. However, it is regarded as an incomplete protein, with lysine being a limiting amino acid.
OBJECTIVES


Our objectives were to determine the bioavailability of lysine in school-age children consuming cooked white rice and to assess the effect of rice starch retrogradation.
METHODS


Bioavailability or metabolic availability (MA) of lysine was determined using the indicator amino acid oxidation (IAAO) method in a repeated-measures design. Six healthy school-age children (3 boys, 3 girls) with a mean ± SD age of 6.8 ± 0.98 y randomly received 4 crystalline l-lysine intakes (2, 6, 10, 14 mg · kg-1 · d-1), and 5 rice intakes to provide lysine at 8, 11, or 14 mg · kg-1 · d-1. The 14 mg · kg-1 · d-1 intakes were measured twice as warm rice and once as cold rice (to assess the impact of starch retrogradation on MA). Diets provided protein at 1.5 g · kg-1 · d-1 and calories at 1.7 times the participant's measured resting energy requirement, and were isonitrogenous. Breath samples were collected at baseline and during an isotopic steady state for 13C enrichment measurement. The MA of lysine from rice was determined by comparing the IAAO response of rice with l-lysine using the slope-ratio and single intake methods. Starch retrogradation was characterized using differential scanning calorimetry.
RESULTS


MA of lysine in warm rice measured in school-age children was 97.5% and was similar to a repeated rice study (97.1%) within the same study population. MA of lysine was reduced significantly (P < 0.05) to 86.1% when the cooked rice was consumed cold, which corresponded to detectable starch retrogradation.
CONCLUSIONS


To our knowledge, this is the first study to measure the MA of lysine from rice in school-age children. Although the bioavailability of lysine from rice is high, it can be reduced by retrogradation of its starch component.This trial was registered at clinicaltrials.gov as NCT04135040.",2020,"MA of lysine was reduced significantly (P < 0.05) to 86.1% when the cooked rice was consumed cold, which corresponded to detectable starch retrogradation.
","['Six healthy school-age children (3 boys, 3 girls) with a mean\xa0±\xa0SD age of 6.8\xa0±', 'School-Age Children', 'school-age children', 'school-age children consuming cooked white rice']","['4 crystalline l-lysine intakes', 'Consuming Rice']","['MA of lysine', 'bioavailability of lysine', 'Lysine Bioavailability']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0452712', 'cui_str': 'White rice'}]","[{'cui': 'C0444626', 'cui_str': 'Crystal'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",6.0,0.0258723,"MA of lysine was reduced significantly (P < 0.05) to 86.1% when the cooked rice was consumed cold, which corresponded to detectable starch retrogradation.
","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Caballero', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Mandal', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anubhav', 'Initials': 'A', 'LastName': 'Pratap-Singh', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Kitts', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa276']
2898,33025010,Associations between Diet Quality and Body Composition in Young Children Born with Very Low Body Weight.,"BACKGROUND


Very low birth weight (VLBW; <1500 g) infants have increased adiposity and metabolic disease risk in adulthood. Limited evidence suggests low-quality childhood diets are a predisposing risk factor. Despite this, to our knowledge no study has yet examined associations between diet quality and body composition in VLBW individuals.
OBJECTIVE


The objective of this study was to determine associations between Healthy Eating Index-2010 (HEI-2010) scores and consumption of fruits/vegetables, added sugars, and macronutrients with body composition in 5.5-y-old children born VLBW. We hypothesized HEI-2010 scores were inversely associated with adiposity.
METHODS


This cohort study leveraged the 5.5-y follow-up to the Donor Milk for Improved Neurodevelopmental Outcomes randomized controlled trial. From June 2016 to July 2018, participants attended a follow-up visit at The Hospital for Sick Children, Canada, or were visited in their home. All 316 surviving infants from the trial were eligible, and the caregivers of 158 children (50%; 53% male) consented to follow-up. Diet quality (HEI-2010) and usual intake of fruits/vegetables, added sugars, and macronutrients were determined from two 24-h dietary recalls (ASA24). Linear regressions evaluated associations of diet with BMI (kg/m2) and waist circumference z-scores, total fat, fat-free mass (air displacement plethysmography), and skinfolds.
RESULTS


Mean ± SD age at follow-up was 5.7 ± 0.2 y, birth weight was 1013 ± 264 g, and gestational age was 27.9 ± 2.5 wk. Dietary data and BMI z-scores were available for all children; 123 completed air displacement plethysmography. HEI-2010 score was 58.2 ± 12.4 out of 100, and 27% of children had poor quality diets (scores ≤50). HEI-2010 scores were inversely associated with BMI z-score, but only in children with obese mothers. A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
CONCLUSIONS


Improving diet quality in children born VLBW with obese mothers may be an important strategy to prevent excess adiposity. This trial was registered at clinicaltrials.gov as Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten, NCT02759809.",2020,"A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
","['5.5-y-old children born VLBW', 'From June 2016 to July 2018, participants attended a follow-up visit at The Hospital for Sick Children, Canada, or were visited in their home', 'All 316 surviving infants from the trial were eligible, and the caregivers of 158 children (50%; 53% male) consented to follow-up', 'Mean ± SD age at follow-up was 5.7 ± 0.2 y, birth weight was 1013 ± 264 g, and gestational age was 27.9 ± 2.5 wk', 'children born VLBW with obese mothers', 'children with obese mothers', 'Very low birth weight (VLBW', 'Young Children Born with Very Low Body Weight']",[],"['HEI-2010 scores', 'BMI z-score', 'Diet Quality and Body Composition', 'HEI-2010 score', 'Dietary data and BMI z-scores', 'diet with BMI (kg/m2) and waist circumference z-scores, total fat, fat-free mass (air displacement plethysmography), and skinfolds', 'poor quality diets', 'adiposity and metabolic disease risk', 'Healthy Eating Index-2010 (HEI-2010) scores and consumption of fruits/vegetables, added sugars, and macronutrients with body composition', 'Diet quality (HEI-2010) and usual intake of fruits/vegetables, added sugars, and macronutrients']","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.114928,"A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
","[{'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'McGee', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Birken', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Pausova', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bando', 'Affiliation': 'Translational Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa281']
2899,33025021,Participant engagement in a community based participatory research study to reduce alcohol use among Latino immigrant men.,"Although Latino immigrant men experience many health disparities, they are underrepresented in research to understand and address disparities. Community Based Participatory Research (CBPR) has been identified to encourage participant engagement and increase representation in health disparities research. The CBPR conceptual model describes how partnership processes and study design impact participant engagement in research. Using this model, we sought to describe how these domains influenced participant engagement in a pilot randomized controlled trial of brief intervention for unhealthy alcohol use (n = 121) among Latino immigrant men. We conducted interviews with a sample of study participants (n = 25) and reviewed logs maintained by 'promotores'. We identified facilitators of participant engagement, including the relevance of the study topic, alignment with participants' goals to improve their lives, partnerships with study staff that treated participants respectfully and offered access to resources. Further, men reported that the study time and location were convenient and that they appreciated being compensated for their time. Barriers to participant engagement included survey questions that were difficult to understand and competing demands of work responsibilities. Findings suggest that engaging underserved communities requires culturally responsive and community engagement strategies that promote trust. Future studies should further investigate how CBPR partnership processes can inform intervention research.",2020,"Using this model, we sought to describe how these domains influenced participant engagement in a pilot randomized controlled trial of brief intervention for unhealthy alcohol use (n = 121) among Latino immigrant men.","[""interviews with a sample of study participants (n\u2009=\u200925) and reviewed logs maintained by 'promotores"", 'Latino immigrant men']",[],[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],[],,0.0179277,"Using this model, we sought to describe how these domains influenced participant engagement in a pilot randomized controlled trial of brief intervention for unhealthy alcohol use (n = 121) among Latino immigrant men.","[{'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Torres', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Ceballos', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Duran', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}]",Health education research,['10.1093/her/cyaa039']
2900,33025051,Caffeine increases whole-body fat oxidation during 1 h of cycling at Fatmax.,"PURPOSE


The ergogenic effect of caffeine on exercise of maximum intensity has been well established. However, there is controversy regarding the effect of caffeine on shifting substrate oxidation at submaximal exercise. The aim of this study was to investigate the effect of acute caffeine ingestion on whole-body substrate oxidation during 1 h of cycling at the intensity that elicits maximal fat oxidation (Fatmax).
METHODS


In a double-blind, randomized, and counterbalanced experiment, 12 healthy participants (VO 2max  = 50.7 ± 12.1 mL/kg/min) performed two acute experimental trials after ingesting either caffeine (3 mg/kg) or a placebo (cellulose). The trials consisted of 1 h of continuous cycling at Fatmax. Energy expenditure, fat oxidation rate, and carbohydrate oxidation rate were continuously measured by indirect calorimetry.
RESULTS


In comparison to the placebo, caffeine increased the amount of fat oxidized during the trial (19.4 ± 7.7 vs 24.7 ± 9.6 g, respectively; P = 0.04) and decreased the amount of carbohydrate oxidized (94.6 ± 30.9 vs 73.8 ± 32.4 g; P = 0.01) and the mean self-perception of fatigue (Borg scale = 11 ± 2 vs 10 ± 2 arbitrary units; P = 0.05). In contrast, caffeine did not modify total energy expenditure (placebo = 543 ± 175; caffeine = 559 ± 170 kcal; P = 0.60) or mean heart rate (125 ± 13 and 127 ± 9 beats/min; P = 0.30) during exercise. Before exercise, caffeine increased systolic and diastolic blood pressure whilst it increased the feelings of nervousness and vigour after exercise (P < 0.05).
CONCLUSION


These results suggest that a moderate dose of caffeine (3 mg/kg) increases the amount of fat oxidized during 1 h of cycling at Fatmax. Thus, caffeine might be used as an effective strategy to enhance body fat utilization during submaximal exercise. The occurrence of several side effects should be taken into account when using caffeine to reduce body fat in populations with hypertension or high sensitivity to caffeine.",2020,"Before exercise, caffeine increased systolic and diastolic blood pressure whilst it increased the feelings of nervousness and vigour after exercise (P < 0.05).
",['12 healthy participants (VO 2max \u2009=\u200950.7\u2009±\u200912.1\xa0mL/kg/min) performed two acute experimental trials after ingesting either'],"['acute caffeine ingestion', 'caffeine', 'Caffeine', 'placebo (cellulose', 'placebo, caffeine']","['systolic and diastolic blood pressure', 'feelings of nervousness and vigour after exercise', 'mean heart rate', 'total energy expenditure', 'amount of fat oxidized', 'mean self-perception of fatigue', 'amount of carbohydrate oxidized', 'body fat oxidation', 'Energy expenditure, fat oxidation rate, and carbohydrate oxidation rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",12.0,0.0945576,"Before exercise, caffeine increased systolic and diastolic blood pressure whilst it increased the feelings of nervousness and vigour after exercise (P < 0.05).
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Faculty of Education, Francisco de Vitoria University, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'González-García', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Giráldez-Costas', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Pérez-García', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Camino del Molino, s/n, 28943, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-020-02393-z']
2901,33025056,Effects of unloader bracing on clinical outcomes and articular cartilage regeneration following microfracture of isolated chondral defects: a randomized trial.,"PURPOSE


To determine whether the use of an unloading brace can increase the thickness of cartilage regenerate after microfracture surgery.
METHODS


This is a randomized (1:1) controlled clinical trial. Twenty-four patients who underwent microfracture between 2012 and 2015 were identified and were randomly assigned to an unloading brace group or a no-brace group. All patients were kept non-weight bearing for the first eight weeks after surgery and then patients in the intervention group began using an unloading brace for an average of 63.9 (SD = 41.6) days to protect clot stability by exerting a varus or valgus force on the knee to decrease the force on the knee's lateral or medial compartment, respectively. Quality of the cartilage repair was assessed with knee magnetic resonance imaging to determine repair tissue thickness (primary outcome), repair tissue volume, and T2 relaxation times at 12 and 24 months after surgery. Clinical outcomes were evaluated with KOOS, Tegner, SF12, and Lysholm questionnaires at six, 12 and 24 months after surgery.
RESULTS


Three patients were lost to follow-up, resulting in 21 patients ultimately analyzed. The unloading brace repair tissue was greater than the no-brace group in volume (26.8 ± 23.7 mm 3  vs - 8.4 ± 22.7 mm 3 , p = 0.005) and thickness (0.2 ± 0.2 mm versus - 0.4 ± 0.3 mm, p = 0.001) at 12 months and in cartilage thickness in the unloading brace group at 24 months (0.4 ± 0.4 mm versus - 0.1 ± 0.3 mm, p = 0.029). There was a positive correlation between wearing the brace longer and improved 6-month KOOS symptom scores (r = 0.82, p = 0.013), 6-month KOOS QOL scores (r = 0.80, p = 0.017), 6-month Tegner scores (r = 0.94, p = 0.002), and Tegner score changes from baseline to 6 months (r = 0.80, p = 0.032).
CONCLUSION


This study found a significant mid-term increase in cartilage repair tissue thickness following unloading bracing in patients recovering from microfracture for isolated chondral defects.
LEVEL OF EVIDENCE


II.",2020,"There was a positive correlation between wearing the brace longer and improved 6-month KOOS symptom scores (r = 0.82, p = 0.013), 6-month KOOS QOL scores (r = 0.80, p = 0.017), 6-month Tegner scores (r = 0.94, p = 0.002), and Tegner score changes from baseline to 6 months (r = 0.80, p = 0.032).
","['microfracture of isolated chondral defects', 'patients recovering from microfracture for isolated chondral defects', 'Twenty-four patients who underwent microfracture between 2012 and 2015']","['unloader bracing', 'unloading brace', 'unloading brace group or a no-brace group']","['clinical outcomes and articular cartilage regeneration', 'unloading brace repair tissue', 'cartilage thickness', 'KOOS, Tegner, SF12, and Lysholm questionnaires', '6-month KOOS symptom scores', 'Tegner score changes', 'repair tissue thickness (primary outcome), repair tissue volume, and T2 relaxation times', 'thickness of cartilage regenerate', 'cartilage repair tissue thickness', '6-month Tegner scores', '6-month KOOS QOL scores']","[{'cui': 'C1265651', 'cui_str': 'Microfracture'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",24.0,0.0944448,"There was a positive correlation between wearing the brace longer and improved 6-month KOOS symptom scores (r = 0.82, p = 0.013), 6-month KOOS QOL scores (r = 0.80, p = 0.017), 6-month Tegner scores (r = 0.94, p = 0.002), and Tegner score changes from baseline to 6 months (r = 0.80, p = 0.032).
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Konopka', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University Medical Center, 450 Broadway, MC 6342, Redwood City, CA, 94063, USA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Finlay', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University Medical Center, 450 Broadway, MC 6342, Redwood City, CA, 94063, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Anatomy, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Dragoo', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University Medical Center, 450 Broadway, MC 6342, Redwood City, CA, 94063, USA. j.dragoo@cuanschutz.edu.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06228-6']
2902,33028550,Trial Of Neurostimulation In Conversion Symptoms (TONICS): a feasibility randomised controlled trial of transcranial magnetic stimulation for functional limb weakness.,"OBJECTIVES


Transcranial magnetic stimulation (TMS) has been used therapeutically for functional (conversion) motor symptoms but there is limited evidence for its efficacy and the optimal protocol. We examined the feasibility of a novel randomised controlled trial (RCT) protocol of TMS to treat functional limb weakness.
DESIGN


A double-blind (patient, outcome assessor) two parallel-arm, controlled RCT.
SETTING


Specialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK.
PARTICIPANTS


Patients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition). Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment.
INTERVENTIONS


Patients were randomised to receive either active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold). Both groups received two TMS sessions, 4 weeks apart.
OUTCOME MEASURES


We assessed recruitment, randomisation and retention rates. The primary outcome was patient-rated symptom change (Clinical Global Impression-Improvement scale, CGI-I). Secondary outcomes included clinician-rated symptom change, psychosocial functioning and disability. Outcomes were assessed at baseline, both TMS visits and at 3-month follow-up.
RESULTS


Twenty-two patients were recruited and 21 (96%) were successfully randomised (active=10; inactive=11). Nineteen (91%) patients were included at follow-up (active=9; inactive=10). Completion rates for most outcomes were good (80%-100%). Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%). Adverse events were not more common for the active treatment. Treatment effect sizes for patient-rated CGI-I scores were small-moderate (Cliff's delta=-0.1-0.3, CIs-0.79 to 0.28), reflecting a more positive outcome for the active treatment (67% and 44% of active arm-rated symptoms as 'much improved' at session 2 and follow-up, respectively, vs 20% inactive group). Effect sizes for secondary outcomes were variable.
CONCLUSIONS


Our protocol is feasible. The findings suggest that supramotor threshold TMS of M1 is safe, acceptable and potentially beneficial as a treatment for functional limb weakness. A larger RCT is warranted.
TRIAL REGISTRATION NUMBER


ISRCTN51225587.",2020,"Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%).","['functional limb weakness', 'Specialist neurology and neuropsychiatry services at a large National Health Service Foundation Trust in London, UK', 'Patients with a diagnosis of functional limb weakness (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition', 'Exclusion criteria included comorbid neurological or major psychiatric disorder, contraindications to TMS or previous TMS treatment', 'Twenty-two patients were recruited and 21 (96']","['TMS', 'active (single-pulse TMS to primary motor cortex (M1) above resting motor threshold) or inactive treatment (single-pulse TMS to M1 below resting motor threshold', 'Transcranial magnetic stimulation (TMS', 'transcranial magnetic stimulation', 'Neurostimulation']","['patient-rated symptom change (Clinical Global Impression-Improvement scale, CGI-I', 'Adverse events', 'Completion rates', 'clinician-rated symptom change, psychosocial functioning and disability']","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0870956', 'cui_str': 'Neuropsychiatry'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",22.0,0.502793,"Most patients were satisfied/very satisfied with the trial in both groups, although ratings were higher in the inactive arm (active=60%, inactive=92%).","[{'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Pick', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Biba', 'Initials': 'B', 'LastName': 'Stanton', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Eskander', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Stavropoulos', 'Affiliation': ""Department of Clinical Neurophysiology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Samra', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bottini', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Hena', 'Initials': 'H', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Purves', 'Affiliation': ""Department of Clinical Neurophysiology, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Nicholson', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK timothy.nicholson@kcl.ac.uk.""}]",BMJ open,['10.1136/bmjopen-2020-037198']
2903,33028554,"INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn (INCARO): a multicentre, open-label, randomised controlled trial - study protocol.","INTRODUCTION


CT is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media use improves CT quality but may cause post-contrast acute kidney injury (PC-AKI). Retrospective studies show no association between reduced baseline renal function and IV contrast CT, but, to our knowledge, no data from randomised controlled trials exist.
METHODS AND ANALYSIS


The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV contrast-enhanced CT to native CT in patients requiring emergency abdominal or body CT with impaired renal function defined as an estimated glomerular filtration rate (eGFR) of 15 to 45 mL/min/1.73 m 2 . The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT. Secondary outcomes are AKI measured by KDIGO (The Kidney Disease: Improving Global Outcomes) criteria within 72 hours from CT, organ dysfunction defined by mSOFA (modified Sequential Organ Failure Assessment) criteria after 48 hours from CT, alive and hospital-free days within 90 days after CT, and time from imaging to definitive treatment. All-cause mortality, need for RRT and renal transplant in long-term follow-up are also measured. The calculated sample size is 994 patients. Patient recruitment is estimated to take 3 years.
ETHICS AND DISSEMINATION


The Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER


NCT04196244.",2020,The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT.,"['patients with acute Abdomen and impaired Renal functiOn (INCARO', 'acute abdominal pain in adults', 'patients requiring emergency abdominal or body CT with impaired renal function defined as an estimated glomerular filtration rate (eGFR) of 15 to 45\u2009mL/min/1.73 m 2 ', '994 patients', 'patients with acute Abdomen and impaired Renal functiOn']","['IV contrast-enhanced CT to native CT', 'INtravenous Contrast computed tomography versus native computed tomography', 'INCARO (INtravenous Contrast computed tomography versus native computed tomography', 'Intravenous (IV) contrast media']","['CT quality', 'AKI measured by KDIGO (The Kidney Disease: Improving Global Outcomes) criteria within 72 hours from CT, organ dysfunction defined by mSOFA (modified Sequential Organ Failure Assessment) criteria after 48 hours from CT, alive and hospital-free days', 'composite of all-cause mortality or renal replacement therapy (RRT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000727', 'cui_str': 'Acute abdomen'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0740577', 'cui_str': 'Acute abdominal pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",,0.168253,The primary outcome is a composite of all-cause mortality or renal replacement therapy (RRT) within 90 days from CT.,"[{'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Räty', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Mentula', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lampela', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Nykänen', 'Affiliation': 'Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Helanterä', 'Affiliation': 'Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Haapio', 'Affiliation': 'Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Lehtimäki', 'Affiliation': 'Department of Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Leppäniemi', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland ville.sallinen@helsinki.fi.'}]",BMJ open,['10.1136/bmjopen-2020-037928']
2904,33028555,"The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial.","INTRODUCTION


Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.
AIMS


To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.
METHODS AND ANALYSIS


This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.
ETHICS AND DISSEMINATION


The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.
TRIAL REGISTRATION NUMBER


Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).",2020,"Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others.","['All participants will be actively referred to behavioural support from telephone Quitline', 'Adults with a history of smoking ≥10 cigarettes per day on average in the 4\u2009weeks prior to their hospitalisation will be recruited', 'assisting hospitalised smokers to quit', 'hospitalised smokers (VANISH']","['nicotine lozenges', 'varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges', 'varenicline', 'varenicline alone', 'varenicline and nicotine replacement therapy (NRT) lozenges', 'placebo']","['feasibility, efficacy and safety', 'efficacy and safety', 'self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others', 'carbon monoxide validated prolonged abstinence', 'intensity of withdrawal symptoms and cravings']","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1253423', 'cui_str': 'Nicotine Lozenges'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.151259,"Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others.","[{'ForeName': 'Rukshar Kaizerali', 'Initials': 'RK', 'LastName': 'Gobarani', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Abramson', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Weeks', 'Affiliation': 'Pharmacy Department, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dooley', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Smith', 'Affiliation': 'General and Respiratory Medicine, Bendigo Health, Bendigo, Victoria, Australia.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Veale', 'Affiliation': 'Department of Respiratory Medicine, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Department of Anaesthesia and Pain Management, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kirsa', 'Affiliation': 'Pharmacy Department, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Priority Research Centre for Healthy Lungs, The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Respiratory and Sleep Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Department of General Medicine, Barwon Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Parkinson', 'Affiliation': 'Pharmacy Department, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Darshana', 'Initials': 'D', 'LastName': 'Meanger', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Coward', 'Affiliation': 'Department of Anaesthesia, Frankston Hospital, Frankston, Victoria, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Kopsaftis', 'Affiliation': 'Respiratory Medicine and Clinical Practice Unit, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Rofe', 'Affiliation': 'Pharmacy Department, Eastern Health Foundation, Box Hill, Victoria, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Lee', 'Affiliation': 'Pharmacy Department, Eastern Health Foundation, Box Hill, Victoria, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia johnson.george@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2020-038184']
2905,33028557,Physical activity and health promotion for nursing staff in elderly care: a study protocol for a randomised controlled trial.,"INTRODUCTION


Nursing staff is burdened by high workload and stress. Furthermore, heavy lifting, as well as transferring nursing home residents, cause lumbar tissue damage and back pain. Exercise intervention studies to reduce work-related problems are rare and the evidence for efficacy of studies among nurses is limited. Studies including targeted analysis of requirements are necessary to generate effective recommendations and tailored interventions for health promotion programmes. The purpose of this multicentred intervention study is to identify work-related problems, to implement health promotion programmes and to evaluate their effectiveness.
METHODS AND ANALYSIS


A randomised controlled trial will be conducted, including a total of 48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses. Standardised ergonomics and posture training (10 weeks, once a week for 20-30 min) and subsequently, back-fitness training (12 weeks, once a week for 45-60 min) will be administered. Following the implementation of standardised health promotion programmes, further demand-oriented interventions can be implemented. The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
ETHICS AND DISSEMINATION


The study was reviewed and approved by the local ethics committee of the University of Hamburg (AZ: 2018_168). The results of the study will be published in open-access and international journals. Furthermore, the results will be presented in the participating nursing homes and at national and international conferences.
TRIAL REGISTRATION NUMBER


DRKS.de (DRKS00015241).",2020,"The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
","['48 nursing home facilities in eight regions of Germany with an estimated sample size of 700 nurses', 'nursing staff in elderly care']","['Physical activity and health promotion', 'Standardised ergonomics and posture training', 'Exercise intervention']",[],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0878008,"The perceived exposure to work-related demands, work-related pain in different parts of the body, health-related quality of life, perceived stress, work-related patterns of behaviour and experience, presentism behaviour, work environment as well as general needs and barriers to health promotion, will be assessed at baseline (pre-test), at 10 weeks (post-test, after ergonomics training), at 22 weeks (post-test, after back-fitness training) and at 34 weeks of the programme (follow-up).
","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Otto', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany ann-kathrin.otto@uni-hamburg.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Pietschmann', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Luisa-Marie', 'Initials': 'LM', 'LastName': 'Appelles', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bebenek', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bischoff', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hildebrand', 'Affiliation': 'Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Johnen', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jöllenbeck', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klotzbier', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Korbus', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rudisch', 'Affiliation': 'Institute of Sport and Exercise Sciences, University of Münster, Münster, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Schott', 'Affiliation': 'Department of Sports and Exercise Science, University of Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Voelcker-Rehage', 'Affiliation': 'Institute of Sport and Exercise Sciences, University of Münster, Münster, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Vogel', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weigelt', 'Affiliation': 'Department of Sport and Health, University of Paderborn, Paderborn, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Institute of Sports Sciences, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Zwingmann', 'Affiliation': 'Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Biological Psychology and Neuroergonomics, Technical University of Berlin, Berlin, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038202']
2906,33028707,Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study.,"Tinnitus is a phantom auditory perception coded in the brain that can be bothersome or debilitating, affecting 10 to 15% of the population. Currently, there is no clinically recommended drug or device treatment for this major health condition. Animal research has revealed that sound paired with electrical somatosensory stimulation can drive extensive plasticity within the brain for tinnitus treatment. To investigate this bimodal neuromodulation approach in humans, we evaluated a noninvasive device that delivers sound to the ears and electrical stimulation to the tongue in a randomized, double-blinded, exploratory study that enrolled 326 adults with chronic subjective tinnitus. Participants were randomized into three parallel arms with different stimulation settings. Clinical outcomes were evaluated over a 12-week treatment period and a 12-month posttreatment phase. For the primary endpoints, participants achieved a statistically significant reduction in tinnitus symptom severity at the end of treatment based on two commonly used outcome measures, Tinnitus Handicap Inventory (Cohen's  d  effect size: -0.87 to -0.92 across arms;  P  < 0.001) and Tinnitus Functional Index (-0.77 to -0.87;  P  < 0.001). Therapeutic improvements continued for 12 months after treatment for specific bimodal stimulation settings, which had not previously been demonstrated in a large cohort for a tinnitus intervention. The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events. These positive therapeutic and long-term results motivate further clinical trials toward establishing bimodal neuromodulation as a clinically recommended device treatment for tinnitus.",2020,The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events.,['326 adults with chronic subjective tinnitus'],['Bimodal neuromodulation combining sound and tongue stimulation'],"['Tinnitus Handicap Inventory ', 'tinnitus symptom severity', 'Tinnitus Functional Index', 'high compliance and satisfaction rates', 'tinnitus symptoms']","[{'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0155533', 'cui_str': 'Subjective tinnitus'}]","[{'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",326.0,0.219877,The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events.,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Conlon', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg 93053, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hamilton', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Meade', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Ciara O', 'Initials': 'CO', 'LastName': 'Connor', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg 93053, Germany.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Hall', 'Affiliation': 'National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham NG7 2UH, UK.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Lab for Clinical and Integrative Neuroscience, School of Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX 75080, USA.'}, {'ForeName': 'Sook Ling', 'Initials': 'SL', 'LastName': 'Leong', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Thavakumar', 'Initials': 'T', 'LastName': 'Subramaniam', 'Affiliation': ""Department of Otolaryngology, St. James's Hospital, Dublin D08 NHY1, Ireland.""}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': ""D'Arcy"", 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland.'}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Lim', 'Affiliation': 'Neuromod Devices Limited, Dublin D08 R2YP, Ireland. hubert.lim@neuromoddevices.com.'}]",Science translational medicine,['10.1126/scitranslmed.abb2830']
2907,33028796,Influence of zirconia surface treatments of a bilayer restorative assembly on the fatigue performance.,"PURPOSE


This study evaluated the influence of different surface treatments of zirconia used to enhance bonding with veneering porcelain, and thermocycling on the resistance to porcelain cracking and delamination during fatigue test.
METHODS


Bilayer ceramic discs were made from zirconia blocks (IPS e.max Zircad MO, Ivoclar Vivadent - 0.7 mm thickness) and randomized into 8 groups (n= 15) according to two factors: 'zirconia surface treatment' (Control; Grinding - diamond bur; Air-abrasion - aluminum oxide particles; and Liner - application of a ceramic liner [IPS e.max Zirliner, Ivoclar Vivadent]); and 'thermocycling' (presence - 12,000 thermal cycles; 5-55ºC; or absence). The discs were veneered with porcelain (IPS e.max Ceram, Ivoclar Vivadent - 0.7 mm; totaling 1.4 mm thickness) according to ISO 6872:2015 for biaxial flexure strength testing. Fatigue tests (step-stress approach; 20 to 100 MPa; step of 10 MPa; 10,000 cycles per step; 10 Hz frequency) were run, followed by the data analysis (Kaplan-Meier and Mantel-Cox post-hoc tests). Analysis of roughness, topography, crystallographic phase arranges and fractography were also executed.
RESULTS


The surface treatment and thermocycling did not influence the porcelain crack nor delamination resistance. When only comparing the surface treatments for crack resistance outcome, the liner application depicted the worst fatigue performance in comparison to grinding and air-abrasion, while all groups were similar for delamination.
CONCLUSIONS


Neither the surface treatment of the zirconia nor the thermocycling influences the porcelain crack resistance or the resistance to delamination of the bilayer porcelain-veneered zirconia specimens.",2020,Neither the surface treatment of the zirconia nor the thermocycling influences the porcelain crack resistance or the resistance to delamination of the bilayer porcelain-veneered zirconia specimens.,"['Bilayer ceramic discs were made from zirconia blocks (IPS e.max Zircad MO, Ivoclar Vivadent - 0.7 mm thickness) and randomized into 8 groups (n= 15) according to two factors: ']","['zirconia', ""zirconia surface treatment' (Control; Grinding - diamond bur; Air-abrasion - aluminum oxide particles; and Liner - application of a ceramic liner [IPS e.max Zirliner, Ivoclar Vivadent]); and 'thermocycling' (presence - 12,000 thermal cycles; 5-55ºC; or absence""]","['Fatigue tests', 'porcelain crack resistance', 'fatigue performance', 'porcelain crack nor delamination resistance']","[{'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011392', 'cui_str': 'Dental porcelain material'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0441514', 'cui_str': 'Delamination'}]",,0.0135204,Neither the surface treatment of the zirconia nor the thermocycling influences the porcelain crack resistance or the resistance to delamination of the bilayer porcelain-veneered zirconia specimens.,"[{'ForeName': 'Pablo Soares', 'Initials': 'PS', 'LastName': 'Machado', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}, {'ForeName': 'Gabriel Kalil Rocha', 'Initials': 'GKR', 'LastName': 'Pereira', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}, {'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}, {'ForeName': 'Luís Felipe', 'Initials': 'LF', 'LastName': 'Guilardi', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}, {'ForeName': 'Marília Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Sciences (Prosthodontics Units), Faculty of Odontology, Federal University of Santa Maria (UFSM) Santa Maria, Rio Grande do Sul State.'}]",Journal of prosthodontic research,['10.2186/jpr.JPOR_2019_553']
2908,33029128,No Effect of Anodal tDCS on Verbal Episodic Memory Performance and Neurotransmitter Levels in Young and Elderly Participants.,"Healthy ageing is accompanied by cognitive decline that affects episodic memory processes in particular. Studies showed that anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) may counteract this cognitive deterioration by increasing excitability and inducing neuroplasticity in the targeted cortical region. While stimulation gains are more consistent in initial low performers, relying solely on behavioural measures to predict treatment benefits does not suffice for a reliable implementation of this method as a therapeutic option. Hence, an exploration of the underlying neurophysiological mechanisms regarding the differential stimulation effect is warranted. Glutamatergic metabolites (Glx) and  γ -aminobutyric acid (GABA) are involved in learning and memory processes and can be influenced with tDCS; wherefore, they present themselves as potential biomarkers for tDCS-induced behavioural gains, which are affiliated with neuroplasticity processes. In the present randomized, double-blind, sham-controlled, crossover study, 33 healthy young and 22 elderly participants received anodal tDCS to their left DLPFC during the encoding phase of a verbal episodic memory task. Using MEGA-PRESS edited magnetic resonance spectroscopy (MRS), Glx and GABA levels were measured in the left DLPFC before and after the stimulation period. Further, we tested whether baseline performance and neurotransmitter levels predicted subsequent gains. No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations. Moreover, baseline performance levels did not predict stimulation-induced cognitive gains, nor did Glx or GABA levels. Nevertheless, exploratory analyses suggested a predictive value of the Glx : GABA ratio, with lower ratios at baseline indicating greater tDCS-related gains in delayed recall performance. This highlights the importance of further studies investigating neurophysiological mechanisms underlying previously observed stimulation-induced cognitive benefits and their respective interindividual heterogeneity.",2020,No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations.,"['33 healthy young and 22 elderly participants', 'Young and Elderly Participants']","['Anodal tDCS', 'anodal tDCS to their left DLPFC during the encoding phase of a verbal episodic memory task', 'Glutamatergic metabolites (Glx) and  γ -aminobutyric acid (GABA', 'anodal transcranial direct current stimulation (tDCS', 'tDCS']","['verbal retrieval performances or neurotransmitter concentrations', 'magnetic resonance spectroscopy (MRS), Glx and GABA levels', 'cognitive gains, nor did Glx or GABA levels', 'delayed recall performance', 'Verbal Episodic Memory Performance and Neurotransmitter Levels']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",33.0,0.065342,No beneficial group effects of tDCS emerged in either verbal retrieval performances or neurotransmitter concentrations.,"[{'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Habich', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Slotboom', 'Affiliation': 'Support Center for Advanced Neuroimaging (SCAN), Neuroradiology, University Hospital of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute of Diagnostic and Interventional Neuroradiology, University Hospital of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}]",Neural plasticity,['10.1155/2020/8896791']
2909,33029135,A Randomized Controlled Trial: Comparison of 4% Articaine versus 0.5% Bupivacaine for Ambulatory Orthopedic Surgery under Supraclavicular Block.,"Background


Articaine has been used in many dental and ophthalmic outpatient procedures. In the era of ultrasound-guided regional techniques, we searched for short and potent local anesthetic for patients undergoing ambulatory upper limb procedures. However, studies about articaine efficacy in brachial plexus block are limited. In this study, we compared its safety and efficacy against bupivacaine as a commonly used anesthetic agent for ultrasound-guided supraclavicular brachial plexus block.
Methods


This randomized prospective study was performed at Ain Shams University Hospital from January to March 2020. A total of 117 patients aged 20 to 60 years, with the American Society of Anesthesiologists physical status I and II, were enrolled in the study. Patients were randomly allocated into two groups: in group A, patients received 30 ml articaine 2%, and in group B, patients received 30 ml of bupivacaine 0.5%. We measured motor and sensory block duration as a primary outcome. Other secondary outcomes such as onset of block, duration of analgesia, patient satisfaction, and time to home discharge readiness were also measured.
Results


We analyzed data collected from 97 patients. The motor block duration was significantly shorter in group A (165.73 ± 20.33 min) than in group B (220.27 ± 37.73 min). The onset of motor block was faster in group A (8.73 ± 4.33 min), and the postoperative VAS score was lower in group B. Patients in group A achieved an earlier home discharge of 289.67 ± 2.73 min.
Conclusion


Earlier resolution of articaine block makes it more favorable than bupivacaine for ambulatory surgery. This trial is registered with (NCT04189198).",2020,The motor block duration was significantly shorter in group A (165.73 ± 20.33 min) than in group B (220.27 ± 37.73 min).,"['Ain Shams University Hospital from January to March 2020', 'Ambulatory Orthopedic Surgery under Supraclavicular Block', 'patients undergoing ambulatory upper limb procedures', '97 patients', '117 patients aged 20 to 60 years, with the American Society of Anesthesiologists physical status I and II, were enrolled in the study']","['bupivacaine', 'Bupivacaine', '30\u2009ml articaine', 'Articaine']","['onset of motor block', 'safety and efficacy', 'motor block duration', 'onset of block, duration of analgesia, patient satisfaction, and time to home discharge readiness', 'postoperative VAS score']","[{'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",117.0,0.0907479,The motor block duration was significantly shorter in group A (165.73 ± 20.33 min) than in group B (220.27 ± 37.73 min).,"[{'ForeName': 'Simon H', 'Initials': 'SH', 'LastName': 'Armanious', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Gamal A', 'Initials': 'GA', 'LastName': 'Abdelhameed', 'Affiliation': 'Ain Shams University, Chairman of Anesthesia Department, Cairo, Egypt.'}]",Anesthesiology research and practice,['10.1155/2020/2194873']
2910,33029190,Efficiency of Intervention Counseling Program on the Enhanced Psychological Well-being and Reduced Post-traumatic Stress Disorder Symptoms Among Syrian Women Refugee Survivors.,"Background


The number of individuals displaced from their original countries due to civil wars, hunger, disasters, and international wars is increasing worldwide day by day. These refugees are more vulnerable to Post-Traumatic Stress Disorder (PTSD).
Objective


The present study aimed to examine the effectiveness of the intervention program in improving the well-being and reducing Post-Traumatic Stress Disorder (PTSD) among a sample of Syrian refugee women in Jordan who had been displaced due to civil wars in Syria.
Methods


The study recruited 40 Syrian refugee females in Jordan who were psychologically challenged, with high PTSD symptoms (assessed by PCL) and a psychological well-being impairment (assessed by PWD). The culture of Jordanian society discriminates and affects the Syrian refugee women, rendering them vulnerable to PTSD. Quasi-experimental design was used, wherein the participants were randomly distributed in experimental and control groups (n=20/group). The control group members did not receive any services related to psychological support or psychiatric medications, while the experimental group underwent a counseling program.
Results


The present study demonstrated that the intervention program improves the well-being and reduces PTSD among the Syrian refugee women who constituted the experimental group. The intervention program and the PTSD manifestation were not affected by age. The present study recommended that the program be applied to the refugees in Jordan to improve the well-being of the women in the residential areas.
Conclusion


Furthermore, an intervention on the Jordanian cultural impact on the refugee camps was also essential if the condition for the female refugees worsened. Lastly, the effect of Jordanian culture on Syrian refugees should be investigated since the literature presented a negative impact.",2020,The present study demonstrated that the intervention program improves the well-being and reduces PTSD among the Syrian refugee women who constituted the experimental group.,"['40 Syrian refugee females in Jordan who were psychologically challenged, with high PTSD symptoms (assessed by PCL) and a psychological well-being impairment (assessed by PWD', 'sample of Syrian refugee women in Jordan who had been displaced due to civil wars in Syria']","['Intervention Counseling Program', 'control group members did not receive any services related to psychological support or psychiatric medications, while the experimental group underwent a counseling program']",['Psychological Well-being and Reduced Post-traumatic Stress Disorder Symptoms'],"[{'cui': 'C0018561', 'cui_str': 'Mesocricetus auratus'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0441717', 'cui_str': 'Civil war'}, {'cui': 'C0039138', 'cui_str': 'Syria'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0141224,The present study demonstrated that the intervention program improves the well-being and reduces PTSD among the Syrian refugee women who constituted the experimental group.,"[{'ForeName': ""Ahmad Sa'ad Saleh"", 'Initials': 'ASS', 'LastName': 'Alsheikh Ali', 'Affiliation': 'Department of Psychology, The University of Jordan, Amman, Jordan.'}]",Clinical practice and epidemiology in mental health : CP & EMH,['10.2174/1745017902016010134']
2911,33029267,Fluoroscopy-Guided Blockade of the Greater Occipital Nerve in Cadavers: A Comparison of Spread and Nerve Involvement for Different Injectate Volumes.,"Background


Fluoroscopy-guided blockade of the greater occipital nerve (GON) is an accepted method for treating the symptoms of cervicogenic headaches (CGHs). However, the spread patterns among different injectate volumes of fluoroscopy-guided GON blocks are not well defined.
Objective


A cadaveric study was established to determine the spread patterns of different volumes of dye injectate within a fluoroscopic GON block.  Study Design . Cadaveric study.  Setting . Xingtai Institute of Orthopaedics; Orthopaedic Hospital of Xingtai.
Methods


15 formalin-fixed cadavers with intact cervical spines were randomized in a 1 : 1 : 1 ratio to receive a fluoroscopy-guided GON injection of a 2, 3.5, or 5 ml volume of methylene blue. The suboccipital regions were dissected to investigate nerve involvement.
Results


The suboccipital triangle regions, including the suboccipital nerves and GONs, were deeply stained in all cadavers. The third occipital nerve (TON) was stained in 7 of 10 administered 2 ml injections and in all the 3.5 ml and 5 ml injections. Compared to the 3 ml injectate group, the 5 mL cohort consistently saw injectate spreading to both superficial and distant muscles.  Limitations . Given that cadavers were used in this study, cadaveric soft tissue composition and architecture can potentially become distorted and consequently affect injectate diffusion.
Conclusions


A 3.5 or 5 mL fluoroscopy-guided GON injection of methylene blue successfully stains the GON, TON, and suboccipital nerves. This suggests that such an injection would generate blockade of all three nerve groups, which may contribute to the efficacy of the block for CGH. A volume of 3.5 ml may be enough for the performance of a fluoroscopy-guided GON block for therapeutic purposes.",2020,"Compared to the 3 ml injectate group, the 5 mL cohort consistently saw injectate spreading to both superficial and distant muscles.  ","['15 formalin-fixed cadavers with intact cervical spines', 'Cadavers']","['\n\n\nFluoroscopy-guided blockade of the greater occipital nerve (GON', 'Xingtai', 'fluoroscopy-guided GON injection of a 2, 3.5, or 5\u2009ml volume of methylene blue', 'Fluoroscopy-Guided Blockade']",[],"[{'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0228814', 'cui_str': 'Greater occipital nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}]",[],,0.0468707,"Compared to the 3 ml injectate group, the 5 mL cohort consistently saw injectate spreading to both superficial and distant muscles.  ","[{'ForeName': 'Zhanfeng', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Hospital of Xingtai, Xingtai 054000, China.'}, {'ForeName': 'Shuming', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Hospital of Xingtai, Xingtai 054000, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Hospital of Xingtai, Xingtai 054000, China.'}, {'ForeName': 'Zhanyong', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, Orthopaedic Hospital of Xingtai, Xingtai 054000, China.'}, {'ForeName': 'Sidong', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang 050051, China.'}]",Pain research & management,['10.1155/2020/8925895']
2912,33029262,Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial.,"Background


Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE).
Objective


The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs.
Method


A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation.
Results


The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p<0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p<0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p<0.05).
Conclusion


The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov: Identifier: NCT04031859.",2020,"There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p<0.05).","['two medical centers in Saudi Arabia', 'post TKR surgery patients administered in conjunction with patient education programs', 'potential risk post total knee replacement', '242 patients were enrolled in the study, 121 patients in each group']","['\n\n\nTotal knee replacement (TKR', 'Venous thromboembolism prevention protocol', '2005 Caprini risk assessment tool and no education programs']","['proportion of bilateral TKR', 'mean body mass index', 'VTE complications and readmission events, post TKR surgery', 'readmission rate', 'pulmonary embolism cases', 'deep-vein thrombosis']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",242.0,0.0695712,"There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p<0.05).","[{'ForeName': 'Mariam A', 'Initials': 'MA', 'LastName': 'Alameri', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmaceutical Science, University of Science Malaysia. Penang (Malaysia). m_alamiri15@yahoo.com.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Syed Sulaiman', 'Affiliation': 'Director. Advanced Institute of Medicine and Dentistry, University of Science Malaysia. Penang (Malaysia). sazhar@usm.my.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Ashour', 'Affiliation': 'Deputy Director & Director of Residency Training Programme. Division Head and Consultant of Arthroplasty and Adult Reconstructive Surgery, Orthopaedics Department, Prince Sultan Military Medical City. Riyadh (Saudi Arabia). abuhadeel@gmail.com.'}, {'ForeName': ""Ma'ad F"", 'Initials': 'MF', 'LastName': 'Al-Saati', 'Affiliation': 'Chairmen of the Orthopedic Department. King Abdullah bin Abdulaziz University Hospital, Princess Nourah Bint Abdulrahman University. Riyadh (Saudi Arabia). mfalsaati@kaauh.edu.sa.'}]",Pharmacy practice,['10.18549/PharmPract.2020.3.2025']
2913,33029292,Effect of nutrition education received by teachers on primary school students' nutrition knowledge.,"BACKGROUND/OBJECTIVES


The aim of this study was to assess the effect of nutrition education received by fourth- and fifth-grade teachers in state schools in Famagusta, Northern Cyprus, on their students.
SUBJECTS/METHODS


The aim of this study is to assess the effect of nutrition education received by fourth- and fifth-grade teachers (n = 27) in state schools in Famagusta on their students. Participants (n = 718) were selected through a regional pilot scheme. The teachers were instructed on nutrition by the researcher and provided with a researcher-prepared nutrition education book ""I Am Learning about Healthy Nutrition"". Before receiving their nutrition education, the teachers were pretested to assess their baseline nutrition knowledge. Following receipt of their nutrition education, a posttest, which included the same questions as those in the pretest, was administered to the teachers to assess the effectiveness of the training session. Similarly, students were asked pretest researcher-prepared questions to evaluate their baseline nutrition knowledge level. The teachers were then given a period of three to four weeks to instruct the students in nutrition education. Following this instructional period, a posttest that included the same questions as those in the pretest was administered to the students.
RESULTS


The results showed that there were significant differences between the pre- and posttest scores of both teachers and students; in both groups, the nutrition knowledge level increased ( P  < 0.05).
CONCLUSIONS


These results show that the provision of nutrition education training to teachers positively affected the nutrition knowledge level of both teachers and students.",2020,These results show that the provision of nutrition education training to teachers positively affected the nutrition knowledge level of both teachers and students.,"['Participants (n = 718) were selected through a regional pilot scheme', 'state schools in Famagusta, Northern Cyprus, on their students', 'n = 27) in state schools in Famagusta on their students', ""primary school students' nutrition knowledge""]","['nutrition education', 'nutrition by the researcher and provided with a researcher-prepared nutrition education book ""I Am Learning about Healthy Nutrition', 'nutrition education received by fourth- and fifth-grade teachers', 'nutrition education training']",['nutrition knowledge level'],"[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",718.0,0.0209291,These results show that the provision of nutrition education training to teachers positively affected the nutrition knowledge level of both teachers and students.,"[{'ForeName': 'Cemre', 'Initials': 'C', 'LastName': 'Elmas', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Eastern Mediterranean University, Famagusta 99628, Turkish Republic of Northern Cyprus.'}, {'ForeName': 'Perihan', 'Initials': 'P', 'LastName': 'Arslan', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Sciences, Eastern Mediterranean University, Famagusta 99628, Turkish Republic of Northern Cyprus.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.5.532']
2914,33029293,Effect of nutrition education in reducing sodium intake and increasing potassium intake in hypertensive adults.,"BACKGROUND/OBJECTIVES


Hypertension is the major risk factor for cardiovascular disease, a leading cause of deaths in Korea. The objective of this study was to evaluate the effect of a nutrition education in reducing sodium intake and increasing potassium intake in hypertensive adults.
SUBJECTS/METHODS


Subjects who participated in this study were 88 adults (28 males and 60 females) who were pre-hypertension or untreated hypertensive patients aged ≥ 30 yrs in Gyeonggi Province, Korea. These subjects were divided into 2 groups: a low-sodium education (LS) group and a low-sodium high-potassium education (LSHP) group. Nutrition education of 3 sessions for 12 weeks was conducted. Blood pressure, blood and urine components, nutrient intake, and dietary behavior were compared between the two education groups.
RESULT


Blood pressure was decreased in both groups after the nutrition education ( P  < 0.05). In the LSHP group, levels of blood glucose ( P  < 0.05), total cholesterol ( P  < 0.01), and low-density lipoprotein-cholesterol ( P  < 0.05) were decreased after the program completion. Sodium intake was decreased in both groups after the nutrition education ( P  < 0.05). However, Na/K ratio was only decreased in the LS group ( P  < 0.05). Intake frequency of fish & shellfish was only significantly reduced in the LS group ( P  < 0.05), while intake frequencies of cooked rice, noodles & dumplings, breads & snacks, stew, kimchi, and fish & shellfish were reduced in the LSHP group ( P  < 0.05). Total score of dietary behavior appeared to be effectively decreased in both groups after the education program ( P  < 0.001).
CONCLUSIONS


This education for reducing sodium intake was effective in reducing blood pressure and sodium intake. The education for enhancing potassium intake resulted in positive changes in blood glucose and serum cholesterol levels.",2020,"In the LSHP group, levels of blood glucose ( P  < 0.05), total cholesterol ( P  < 0.01), and low-density lipoprotein-cholesterol ( P  < 0.05) were decreased after the program completion.","['Subjects who participated in this study were 88 adults (28 males and 60 females) who were pre-hypertension or untreated hypertensive patients aged ≥ 30 yrs in Gyeonggi Province, Korea', 'hypertensive adults']","['nutrition education', 'LSHP', 'low-sodium education (LS) group and a low-sodium high-potassium education (LSHP) group']","['total cholesterol', 'levels of blood glucose', 'intake frequencies of cooked rice, noodles & dumplings, breads & snacks, stew, kimchi, and fish & shellfish', 'blood pressure and sodium intake', 'Total score of dietary behavior', 'low-density lipoprotein-cholesterol', 'Blood pressure', 'Blood pressure, blood and urine components, nutrient intake, and dietary behavior', 'Na/K ratio', 'Intake frequency of fish & shellfish', 'blood glucose and serum cholesterol levels', 'Sodium intake']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0856882', 'cui_str': 'Potassium increased'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452689', 'cui_str': 'Noodles'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0036950', 'cui_str': 'Shellfish'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}]",88.0,0.027469,"In the LSHP group, levels of blood glucose ( P  < 0.05), total cholesterol ( P  < 0.01), and low-density lipoprotein-cholesterol ( P  < 0.05) were decreased after the program completion.","[{'ForeName': 'You-Sin', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Home Economics Education, Dongguk University, Seoul 04620, Korea.'}, {'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang 10326, Korea.'}, {'ForeName': 'Sim-Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Home Economics Education, Dongguk University, Seoul 04620, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.5.540']
2915,33029313,Effectiveness of trauma-focused cognitive behavioral therapy for Japanese children and adolescents in community settings: a multisite randomized controlled trial.,"Background


Trauma-focused cognitive behavioural therapy (TF-CBT) is an efficacious treatment model for children and adolescents with trauma-related disorders. However, few studies have been conducted in community settings, and there have been no randomized controlled trials in Asian countries.
Objective


To evaluate the effectiveness of TF-CBT in regular community settings in Japan through comparison with a waitlist with minimal services control condition.
Method


Thirty Japanese children and adolescents with posttraumatic stress disorder symptoms (22 females, eight males, mean age = 13.90, range = 6-18) were randomly assigned to 12 sessions of TF-CBT or the waitlist control condition. The primary outcome measure was the Kiddie Schedule for Affective Disorders and Schizophrenia score assessed by blinded evaluators one month later.
Results


The mean number of sessions was 12 (range: 11-13) in the TF-CBT group and 4.87 (range: 3-7) in the control group. Intention to treat analysis showed that the TF-CBT group achieved significantly greater symptom reduction than did the control group. The effect size (Cohen's  d ) between the TF-CBT and control groups was 0.96 ( p  =.014) for posttraumatic symptoms and 1.15 ( p  =.004) for depressive symptoms. However, the TF-CBT group did not show better results than the control group with regard to improvements in anxiety symptoms, psychosocial functioning, and behavioural problems.
Conclusions


The findings provided preliminary evidence of the effectiveness of TF-CBT for treating youth with trauma in community mental health facilities. TF-CBT in the Japanese context proved identical to the original, demonstrating that it is also suitable for use with children and adolescents in non-Western settings.",2020,"However, the TF-CBT group did not show better results than the control group with regard to improvements in anxiety symptoms, psychosocial functioning, and behavioural problems.
","['regular community settings in Japan through comparison with a waitlist with minimal services control condition', 'Japanese children and adolescents in community settings', 'youth with trauma in community mental health facilities', 'Thirty Japanese children and adolescents with posttraumatic stress disorder symptoms (22 females, eight males, mean age\xa0=\xa013.90, range\xa0', '6-18', 'children and adolescents in non-Western settings', 'children and adolescents with trauma-related disorders']","['\n\n\nTrauma-focused cognitive behavioural therapy (TF-CBT', 'TF-CBT or the waitlist control condition', 'trauma-focused cognitive behavioral therapy', 'TF-CBT']","['Kiddie Schedule for Affective Disorders and Schizophrenia score assessed by blinded evaluators one month later', 'posttraumatic symptoms', 'anxiety symptoms, psychosocial functioning, and behavioural problems', 'depressive symptoms', 'symptom reduction', 'mean number of sessions']","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",30.0,0.0617628,"However, the TF-CBT group did not show better results than the control group with regard to improvements in anxiety symptoms, psychosocial functioning, and behavioural problems.
","[{'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Kameoka', 'Affiliation': 'Research department, Hyogo Institute for Traumatic Stress, Kobe, Hyogo, Japan.'}, {'ForeName': 'Eizaburo', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': 'Research department, Hyogo Institute for Traumatic Stress, Kobe, Hyogo, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Research department, Hyogo Institute for Traumatic Stress, Kobe, Hyogo, Japan.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Faculty of Human Sciences, Mejiro University, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Narisawa', 'Affiliation': 'Division of Consultation, Victim Support Center of Tokyo, Tokyo, Shinjuku-ku, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Division of Consultation, Victim Support Center of Tokyo, Tokyo, Shinjuku-ku, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Nosaka', 'Affiliation': 'Research department, Hyogo Institute for Traumatic Stress, Kobe, Hyogo, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Public Health, Kyoto University Graduate School of Medicine, Yoshida-honmachi, Kyoto, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Asukai', 'Affiliation': 'Division of Consultation, Victim Support Center of Tokyo, Tokyo, Shinjuku-ku, Japan.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1767987']
2916,33029333,Somatic Experiencing® for patients with low back pain and comorbid posttraumatic stress symptoms - a randomised controlled trial.,"Background


Low back pain (LBP) and comorbid post-traumatic stress symptoms (PTSS) are common after traumatic injuries, and a high level of PTSS is associated with more severe pain and pain-related disability. Few randomised controlled trials (RCT) exist targeting comorbid PTSS and chronic pain, and only one has assessed the effect of Somatic Experiencing®.
Objective


The aim of this study was to assess the effect of Somatic Experiencing® (up to 12 sessions) + physiotherapeutic intervention (4-8 sessions) (SE+PT) compared with the physiotherapeutic intervention alone (4-8 sessions) (PT) for pain-related disability in LBP with comorbid PTSS.
Methods


The study was a two-group RCT in which participants ( n  = 114) were recruited consecutively from a large Danish Spine Centre. Patients were randomly allocated to either SE+PT or PT alone. Outcomes were collected at baseline before randomisation, 6 and 12-month post-randomisation. The primary outcome was pain-related disability as measured with the modified version of the Roland Morris Disability Questionnaire at 6-month post-randomisation. Secondary outcomes were PTSS, pain intensity, pain-catastrophising, kinesiophobia, anxiety and depression.
Results


No significant group differences were found on any of the outcomes at any timepoints. Both groups achieved a significant reduction in pain-related disability (20-27%) as measured by the Roland Morris Disability Questionnaire at 6 and 12-month follow up. Also, both groups achieved a small reduction in PTSS.
Conclusions


Although significant effects were achieved for both groups, the additional SE intervention did not result in any additional benefits in any of the outcomes.",2020,"Although significant effects were achieved for both groups, the additional SE intervention did not result in any additional benefits in any of the outcomes.","['participants ( n \xa0=\xa0114) were recruited consecutively from a large Danish Spine Centre', 'patients with low back pain and comorbid posttraumatic stress symptoms ']","['SE+PT or PT alone', 'Somatic Experiencing® (up to 12 sessions) + physiotherapeutic intervention (4-8 sessions) (SE+PT', 'physiotherapeutic intervention alone (4-8 sessions) (PT', 'Somatic Experiencing®']","['PTSS, pain intensity, pain-catastrophising, kinesiophobia, anxiety and depression', 'Roland Morris Disability Questionnaire', 'pain-related disability as measured with the modified version of the Roland Morris Disability Questionnaire', 'pain-related disability']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]","[{'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",114.0,0.188285,"Although significant effects were achieved for both groups, the additional SE intervention did not result in any additional benefits in any of the outcomes.","[{'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Ellegaard', 'Affiliation': 'Spine Centre of Southern Denmark, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Schiøttz-Christensen', 'Affiliation': 'Spine Centre of Southern Denmark, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Manniche', 'Affiliation': 'Spine Centre of Southern Denmark, University of Southern Denmark, Odense, Denmark.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1797306']
2917,33029397,Effect of Exogenous Melatonin Administration in Critically Ill Patients on Delirium and Sleep: A Randomized Controlled Trial.,"Introduction


Sleep deprivation is a contributor for delirium in intensive care. Melatonin has been proposed as a pharmacological strategy to improve sleep, but studies have shown that the increase in plasma levels of melatonin do not correlate to a beneficial clinical effect; in addition, melatonin's short half-life may be a major limitation to achieving therapeutic levels. This study applies a previously published novel regimen of melatonin with proven sustained levels of melatonin during a 12 h period. In this study, the aim is to determine if such melatonin dosing positively influences on the sleep architecture and the incidence of delirium in intensive care.
Methods


Single center, randomized control trial with consecutive recruitment over 5 years. Medical and surgical patients were in a recovery phase, all weaning from mechanical ventilation. Randomized allocation to placebo or enteral melatonin, using a previously described regimen (loading dose of 3 mg at 21 h, followed by 0.5 mg hourly maintenance dose until 03am through a nasogastric tube). Sleep recordings were performed using polysomnogram at baseline (prior to intervention) and the third night on melatonin (postintervention recording). Delirium was assessed using the Richmond Agitation and the Confusion Assessment Method Scales. Environmental light and noise levels were recorded using a luxmeter and sound meter.
Results


80 patients were screened, but 33 were recruited. Sleep studies showed no statistical differences on arousal index or length of sleep. Baseline delirium scores showed no difference between groups when compared to postintervention scores. RASS scores were 1 in both groups at baseline, compared to zero (drug group) and 0.5 (placebo group) posttreatment. CAM scores were zero (drug group) and 1 (placebo group) at baseline, compared to zero (in both groups) postintervention.
Conclusion


High levels of plasma melatonin during the overnight period of intensive care cohort patients did not improve sleep nor decreased the prevalence of delirium. This trial is registered with Anzctr.org.au/ACTRN12620000661976.aspx.",2020,Baseline delirium scores showed no difference between groups when compared to postintervention scores.,"['Critically Ill Patients on Delirium and Sleep', '80 patients were screened, but 33 were recruited']","['Exogenous Melatonin', 'placebo or enteral melatonin', 'Melatonin', 'melatonin']","['plasma melatonin', 'RASS scores', 'Delirium', 'arousal index or length of sleep', 'Baseline delirium scores', 'CAM scores', 'prevalence of delirium', 'Environmental light and noise levels']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",80.0,0.421587,Baseline delirium scores showed no difference between groups when compared to postintervention scores.,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bellapart', 'Affiliation': ""Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Vinesh', 'Initials': 'V', 'LastName': 'Appadurai', 'Affiliation': ""Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lassig-Smith', 'Affiliation': ""Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Stuart', 'Affiliation': ""Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Zappala', 'Affiliation': ""Department of Thoracic Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Boots', 'Affiliation': 'Burns Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Australia.'}]",Critical care research and practice,['10.1155/2020/3951828']
2918,33029412,A comparative study between sacral neuromodulation and intravesical botulinum toxin injection for patients with refractory overactive bladder.,"Objective


To compare the efficacy, safety, patient compliance and quality of life (QoL) (early and at 6 months after treatment), in a group of Iraqi female patients with refractory overactive bladder (OAB), treated with intradetrusor botulinum toxin A (BTX) injections vs sacral neuromodulation (SNM).
Patients and methods


A prospective, clinical interventional study of 37 female patients assessed by history, physical examination, voiding diary, ultrasonography (US), and urodynamics. The patients were assigned to one of two groups: Group 1, treated with cystoscopic BTX injections; and Group 2, treated with SNM. Response to treatment was assessed by voiding diary, the Treatment Benefit Scale, a modified Quality of Life scale, urine culture, and abdominal US.
Results


The mean age of the patients in Group 1 (BTX) was 43.8 years and in Group 2 (SNM) was 37.2 years. OAB-wet was diagnosed in 11 patients in Group 1 and 10 in Group 2. At the 6-month follow-up there were 14/16 and 12/15 positive responders, in groups 1 and 2, respectively; with no major complications. All the responders had a significant improvement in their overall QoL after both types of treatment.
Conclusions


Both BTX and SNM, in our experience, were safe and effective in managing our patients with refractory OAB after 6 months of follow-up, which was also reflected by an improvement in their QoL.
Abbreviations


BTX: botulinum toxin A; IPG: implantable pulse generator; OAB: overactive bladder; PVR: post-void residual urine; QoL: quality of life; SNM: sacral neuromodulation; UDS, urodynamics; UI, urinary incontinence.",2020,"Response to treatment was assessed by voiding diary, the Treatment Benefit Scale, a modified Quality of Life scale, urine culture, and abdominal US.
","['37 female patients assessed by', 'patients with refractory overactive bladder', 'Iraqi female patients with refractory overactive bladder (OAB']","['intravesical botulinum toxin injection', 'intradetrusor botulinum toxin A (BTX) injections vs sacral neuromodulation (SNM', 'cystoscopic BTX injections; and Group 2, treated with SNM']","['overall QoL', 'efficacy, safety, patient compliance and quality of life (QoL', 'OAB-wet', 'history, physical examination, voiding diary, ultrasonography (US), and urodynamics', 'voiding diary, the Treatment Benefit Scale, a modified Quality of Life scale, urine culture, and abdominal US']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C1556087', 'cui_str': 'Iraqi'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",37.0,0.0297017,"Response to treatment was assessed by voiding diary, the Treatment Benefit Scale, a modified Quality of Life scale, urine culture, and abdominal US.
","[{'ForeName': 'Issam S', 'Initials': 'IS', 'LastName': 'Al-Azzawi', 'Affiliation': 'Department of Urology, Al-Mustansiriya University, Baghdad, Iraq.'}, {'ForeName': 'Haider T', 'Initials': 'HT', 'LastName': 'Al-Hindawi', 'Affiliation': 'Department of Urology, Al-Yarmouk Teaching Hospital, Baghdad, Iraq.'}]",Arab journal of urology,['10.1080/2090598X.2020.1740391']
2919,33029415,Miniature semi-rigid ureteroscopy with holmium-yttrium-aluminium-garnet laser vs shockwave lithotripsy in the management of upper urinary tract stones >1 cm in children.,"Objective


To compare the efficacy and safety of miniature semi-rigid ureteroscopy (URS) with holmium (Ho)-yttrium-aluminium-garnet (YAG) laser lithotripsy vs shockwave lithotripsy (SWL) for treating upper urinary tract (UUT) calculi >1 cm in children.
Patients and methods


Children with unilateral single UUT ureteric stones of >1 cm were prospectively enrolled in this study. Patients were randomly divided into two groups: Group 1, treated with SWL; and Group 2, treated with URS (6/7.5 F) and laser lithotripsy. The patients' characteristics, stones demographics, operative time, adjunctive procedures, stone-free rate (SFR), re-treatment rate, and complications were statistically analysed and compared. Success was defined as stone-free status (no stone residual of ≥0.3 cm) at 1 month from the initial treatment without any auxiliary procedures.
Results


In all, 68 patients with UUT stones met our inclusion criteria. There were no significant differences between the two groups for patient or stone demographics. In Group 1, the SFR was 26/34 (76.4%) and in Group 2 it was 33/34 (97.1%) ( P  = 0.03). A total of 12 auxiliary procedures in Group 1 and two in Group 2 were needed to reach a 100% SFR ( P  = 0.014). There were no significant differences between the two groups for operative times, adjunctive procedures, number of complicated cases or complications of Grade ≥III  (P  = 0.65,  P  = 0.23,  P  = 0.77, and  P  = 0.62, respectively).
Conclusion


Miniature semi-rigid URS with Ho-YAG laser lithotripsy for UUT ureteric stones of >1 cm in children was more effective than SWL in terms of SFR and re-treatment rate, with no significant difference in the rate or grade of complications.
Abbreviations


EQ: efficiency quotient; KUB: plain abdominal radiograph of the kidneys, ureters and bladder; RCT: randomised controlled trial; SFR: stone-free rate; SWL: shockwave lithotripsy; URS: ureteroscopy; US: ultrasonography/ultrasound; URS: ureteroscopy; UUT: upper urinary tract; YAG: yttrium-aluminium-garnet.",2020,"There were no significant differences between the two groups for operative times, adjunctive procedures, number of complicated cases or complications of Grade ≥III  ","['children', 'upper urinary tract stones', 'Patients and methods\n\n\nChildren with unilateral single UUT ureteric stones of >1 cm', '68 patients with UUT stones met our inclusion criteria']","['miniature semi-rigid ureteroscopy (URS) with holmium (Ho)-yttrium-aluminium-garnet (YAG) laser lithotripsy vs shockwave lithotripsy (SWL', 'Miniature semi-rigid ureteroscopy with holmium-yttrium-aluminium-garnet laser vs shockwave lithotripsy', 'Ho-YAG laser lithotripsy', 'SWL', 'URS (6/7.5\xa0F) and laser lithotripsy', 'aluminium-garnet']","['SFR', 'efficacy and safety', 'rate or grade of complications', 'stones demographics, operative time, adjunctive procedures, stone-free rate (SFR), re-treatment rate, and complications', 'operative times, adjunctive procedures, number of complicated cases or complications of Grade ≥III']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1690939', 'cui_str': '20/25'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",68.0,0.0318918,"There were no significant differences between the two groups for operative times, adjunctive procedures, number of complicated cases or complications of Grade ≥III  ","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Omran', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Esam A E', 'Initials': 'EAE', 'LastName': 'Desoky', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Ali', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed M H', 'Initials': 'MMH', 'LastName': 'Abdalla', 'Affiliation': 'Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2020.1738105']
2920,33029427,Ureteric stenting vs not stenting following uncomplicated ureteroscopic lithotripsy: A prospective randomised trial.,"Objective


To compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) and to evaluate whether stenting could be eliminated after the procedure, as there is no consensus about whether a ureteric stent should be placed after uncomplicated ureteroscopy for stone retrieval.
Patients and methods


In this randomised clinical trial (NCT04145063) 105 patients underwent uncomplicated URSL for ureteric stones. They were prospectively randomised into three groups: Group 1 (34 patients) with a double pigtail ureteric stent, Group 2 (35 patients) with a double pigtail ureteric stent with extraction string, and Group 3 (36 patients) with no ureteric stent placed after the procedure. The outcomes measured were: postoperative visual analogue scale (VAS) score for flank pain and dysuria score, urgency, frequency, suprapubic pain, haematuria, analgesia requirement, operative time, re-hospitalisation, and return to normal physical activity.
Results


The mean (SD) operative time was significantly longer in groups 1 and 2 compared to Group 3, at 22.2 (9.1), 20.2 (6) and 15.1 (7.1) min, respectively ( P  < 0.001). The results of the VAS for flank pain and dysuria scores, urgency, frequency, haematuria, and suprapubic pain showed a significant difference at all time-points of follow-up, being significantly higher in groups 1 and 2 compared to Group 3 (all  P  < 0.001). Further analysis showed that measured outcomes, and analgesia need for groups 1 and 2 were similar, at all time-points except at week 1 and 1 month where Group 2 patients' had less symptoms ( P  < 0.001).
Conclusion


Double pigtail ureteric stent placement appears to be unnecessary in procedures considered 'uncomplicated' by operating urologists during surgery. The advantages of the double pigtail ureteric stent with extraction string over the double pigtail ureteric stent only include earlier and easier removal with earlier relief of symptoms, and less analgesia requirements.
Abbreviations


KUB: plain abdominal radiograph of the kidneys, ureters and bladder; URSL: ureteroscopic lithotripsy; VAS: visual analogue scale.",2020,"Further analysis showed that measured outcomes, and analgesia need for groups 1 and 2 were similar, at all time-points except at week 1 and 1 month where Group 2 patients' had less symptoms ( P  < 0.001).
",['105 patients underwent uncomplicated URSL for ureteric stones'],"['uncomplicated ureteroscopic lithotripsy (URSL', 'uncomplicated ureteroscopic lithotripsy', 'pigtail ureteric stent placement', 'Ureteric stenting vs not stenting', 'double pigtail ureteric stent, Group 2 (35 patients) with a double pigtail ureteric stent with extraction string, and Group 3 (36 patients) with no ureteric stent placed after the procedure']","['flank pain and dysuria scores, urgency, frequency, haematuria, and suprapubic pain', 'postoperative visual analogue scale (VAS) score for flank pain and dysuria score, urgency, frequency, suprapubic pain, haematuria, analgesia requirement, operative time, re-hospitalisation, and return to normal physical activity', 'mean (SD) operative time', 'analgesia need']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0241310', 'cui_str': 'Suprapubic pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",105.0,0.156851,"Further analysis showed that measured outcomes, and analgesia need for groups 1 and 2 were similar, at all time-points except at week 1 and 1 month where Group 2 patients' had less symptoms ( P  < 0.001).
","[{'ForeName': 'Saddam', 'Initials': 'S', 'LastName': 'Al Demour', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alrabadi', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Abedallatif', 'Initials': 'A', 'LastName': 'AlSharif', 'Affiliation': 'Department of Diagnostic Radiology and Nuclear Medicine, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Mera', 'Initials': 'M', 'LastName': 'Ababneh', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Al-Taher', 'Affiliation': 'Division of Pediatric Surgery, Department of General Surgery, University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Melhem', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Hammam', 'Initials': 'H', 'LastName': 'Mansi', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': ""Sa'id"", 'Initials': 'S', 'LastName': 'Aljamal', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abufaraj', 'Affiliation': 'Department of Special Surgery, Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan.'}]",Arab journal of urology,['10.1080/2090598X.2020.1762280']
2921,33029428,Antegrade mini-percutaneous flexible ureteroscopy versus retrograde ureteroscopy for treating impacted proximal ureteric stones of 1-2 cm: A prospective randomised study.,"Objectives


To prospectively assess the safety and effectiveness of antegrade mini-percutaneous (miniperc) ureteroscopy (URS) and compare it with the conventional retrograde URS (RURS) approach in treating impacted proximal ureteric stones of 1-2 cm.
Patients and methods


The study included 60 patients admitted to the Department of Urology, Alexandria Main University Hospital, presenting with impacted proximal ureteric stones of 1-2 cm. Patients were randomly divided into two groups: Group A, were treated with RURS using a semi-rigid or flexible ureteroscope to access the stone; and Group B, were treated by antegrade miniperc URS, were a 14-F renal tract was obtained to pass a ureteric access sheath, then a flexible ureteroscope was used going downwards to the stone. Holmium laser was used for stone fragmentation. A JJ stent was inserted in all cases. Follow-up with non-contrast computed tomography was performed after 2 weeks.
Results


Both groups were comparable in terms of patient demographics and stone criteria. The stone-free rate was significantly higher in Group B (83.3%) compared to Group A (60%). The mean (SD) operative time was significantly shorter in Group A vs Group B, at 64.7 (±17.7) vs 112.0 (±15.3) min; while the mean lithotripsy time was comparable between the groups. The mean radiation exposure time was significantly less in Group A (11 s) compared to Group B (200 s). Both groups where comparable concerning minor complications, with no major complications.
Conclusion


Antegrade miniperc flexible URS is safe and more effective than RURS for treating large impacted proximal ureteric stones.
Abbreviations


ESWL: extracorporeal shockwave lithotripsy; KUB: plain abdominal radiograph of the kidneys, ureters and bladder; miniperc: mini-percutaneous; PCNL: percutaneous nephrolithotomy; PCS: pelvi-calyceal system; SFR: stone-free rate; (R)URS: (retrograde) ureteroscopy.",2020,The mean radiation exposure time was significantly less in Group A (11 s) compared to Group B (200 s).,"['60 patients admitted to the Department of Urology, Alexandria Main University Hospital, presenting with impacted proximal ureteric stones of 1-2 cm', 'treating impacted proximal ureteric stones of 1-2 cm']","['Abbreviations\n\n\nESWL', 'Antegrade mini-percutaneous flexible ureteroscopy versus retrograde ureteroscopy', 'conventional retrograde URS (RURS) approach', 'extracorporeal shockwave lithotripsy; KUB', 'Holmium laser', 'antegrade mini-percutaneous (miniperc) ureteroscopy (URS', 'RURS using a semi-rigid or flexible ureteroscope to access the stone', 'Follow-up with non-contrast computed tomography']","['stone-free rate', 'mean radiation exposure time', 'mean (SD) operative time', 'safety and effectiveness', 'mean lithotripsy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]",60.0,0.03095,The mean radiation exposure time was significantly less in Group A (11 s) compared to Group B (200 s).,"[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Elgebaly', 'Affiliation': 'Department of Urology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Abdeldayem', 'Affiliation': 'Department of Urology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Idris', 'Affiliation': 'Department of Urology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Elrifai', 'Affiliation': 'Department of Urology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fahmy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2020.1769385']
2922,33029429,Pneumatic vs laser lithotripsy for mid-ureteric stones: Clinical and cost effectiveness results of a prospective trial in a developing country.,"Objective


To compare the management of large ureteric stones (>10 mm) with ureterorenoscopy (URS) and laser or pneumatic lithotripsy, and their associated costs.
Patients and methods


Our prospective study followed the tenets of the Declaration of Helsinki and included 101 patients with large mid-ureteric stones eligible for URS and lithotripsy, and was conducted between January 2018 and August 2019. Patients were randomly divided into two groups: Group 1 had laser lithotripsy, while the Group 2 had lithotripsy using a pneumatic energy source.
Results


Operative time was significantly longer in cases using pneumatic lithotripsy ( P  < 0.001). The stone-free rate (SFR) on the first postoperative day was 94% and 92.5% for laser and pneumatic lithotripsy respectively, and there were no statistically significant differences in terms of early (day 1) or late (day 30) SFRs between the groups. Complications were classified according to the Clavien-Dindo Grading System, all complications were Grade <III, with no statistically significant difference between the groups ( P  = 0.742). The use of pneumatic lithotripsy had lower treatment costs. The number of auxiliary procedures required to reach a stone-free status was statistically equivalent in both groups.
Conclusion


The type of lithotripsy did not affect the SFR or complications. However, laser lithotripsy was much more expensive than pneumatic lithotripsy.
Abbreviations


KUB: plain abdominal radiograph of the kidneys, ureters and bladder; SFR: stone-free rate; SWL: shockwave lithotripsy; URS: Ureterorenoscopy; US: ultrasonography.",2020,"Results


Operative time was significantly longer in cases using pneumatic lithotripsy ( P  < 0.001).","['101 patients with large mid-ureteric stones eligible for URS and lithotripsy, and was conducted between January 2018 and August 2019', 'mid-ureteric stones']","['Pneumatic vs laser lithotripsy', 'laser lithotripsy', 'ureterorenoscopy (URS) and laser or pneumatic lithotripsy', 'pneumatic lithotripsy', 'laser lithotripsy, while the Group 2 had lithotripsy using a pneumatic energy source', 'laser and pneumatic lithotripsy']","['Operative time', 'number of auxiliary procedures required to reach a stone-free status', 'stone-free rate (SFR', 'SFR or complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0014275', 'cui_str': 'Energy-Generating Resources'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",101.0,0.0222632,"Results


Operative time was significantly longer in cases using pneumatic lithotripsy ( P  < 0.001).","[{'ForeName': 'Hani H', 'Initials': 'HH', 'LastName': 'Nour', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Ahmed I', 'Initials': 'AI', 'LastName': 'Kamel', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Elmansy', 'Affiliation': 'Department of Urology, Thundar Bay Regional Health Sciences Center, Thunder Bay, ON, Canada.'}, {'ForeName': 'Mohamad H', 'Initials': 'MH', 'LastName': 'Badawy', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Shabana', 'Affiliation': 'Department of Urology, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abdelwahab', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elbaz', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Eleithy', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}, {'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'Rushdy', 'Affiliation': 'Department of Urology, Theodor Bilharz Research Institute, Giza, Egypt.'}]",Arab journal of urology,['10.1080/2090598X.2020.1749800']
2923,33029458,Comparison of Fiberoptic-Guided Tracheal Intubation Through Intubating Laryngeal Mask Airway (ILMA) FastrachTM and Ambu® Aura-i™: A Randomized Clinical Study.,"Background and aim The primary aim of the study was to compare the intubation characteristics and effectiveness of intubating laryngeal mask airway (ILMA) and Ambu® Aura-i™ as a conduit for facilitating fiberoptic-guided intubation. Methods Eighty patients were enrolled in the randomized-controlled hospital-based study. After inducing general anesthesia, an appropriately sized ILMA (group 1)/Ambu Aura-I (group 2) was placed. Fiberoptic assessment of the glottic view was done followed by fiberoptic-guided tracheal intubation. The time taken for the insertion of ILMA/Ambu Aura-i, glottic view grading, time taken for fiberoptic-guided intubation, ease of intubation, time taken for the removal of ILMA/Ambu Aura-i were recorded. Data analysis was done using the two-tailed independent t-test, paired t-test, and Fisher's exact probability test. Result Anthropometric and airway parameters were similar in both groups. The success rate of the insertion of both devices was 100%. In group 1, the mean time taken for the insertion was 20.53±1.91, and it was 13.98±2.4 in group 2 (P<0.001S). Fiberoptic assessment of the glottic view in group 1 (ILMA group) was grade 1 in 80% of the patients, whereas it was 92% in group 2 (Ambu Aura-i) (P=0.54). The mean time taken for fiberoptic-guided intubation was 14.95±1.85 in group 1 and 14.15±1.37 in group 2 (P>0.001). No significant difference was observed according to the number of attempts in intubating through ILMA/Ambu Aura-i. Seventy-five percent (75%) in group 1 and 87.5% in group 2 were successfully inserted on the first attempt (𝑝 = 0.33). The time taken for the removal of the device was 11.87 +1.265 seconds in group 1 and 11.25±1.58 seconds in group 2 (P=0.054). Conclusion The Ambu Aura-i scores superiorly over ILMA in requiring less time for successful insertion on the basis of statistical analysis and hence appears to be a better independent ventilatory device.",2020,The time taken for the removal of the device was 11.87 +1.265 seconds in group 1 and 11.25±1.58 seconds in group 2 (P=0.054).,['Methods Eighty patients were enrolled in the randomized-controlled hospital-based study'],"['intubating laryngeal mask airway (ILMA) and Ambu® Aura-i™', 'sized ILMA', 'fiberoptic-guided tracheal intubation', 'Fiberoptic-Guided Tracheal Intubation Through Intubating Laryngeal Mask Airway (ILMA) FastrachTM and Ambu® Aura-i™']","['mean time taken for the insertion', 'number of attempts in intubating through ILMA', 'Fiberoptic assessment', 'success rate of the insertion of both\xa0devices', 'Result Anthropometric and airway parameters', 'time taken for the removal of the device', 'mean time taken for fiberoptic-guided intubation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",80.0,0.0549842,The time taken for the removal of the device was 11.87 +1.265 seconds in group 1 and 11.25±1.58 seconds in group 2 (P=0.054).,"[{'ForeName': 'Navya', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Anesthesiology, Mahatma Gandhi Medical College and Hospital, Jaipur, IND.'}, {'ForeName': 'Avnish', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Anesthesiology, Mahatma Gandhi Medical College and Hospital, Jaipur, IND.'}]",Cureus,['10.7759/cureus.10178']
2924,33029528,Effectiveness of Low-Frequency Stimulation in Proprioceptive Neuromuscular Facilitation Techniques for Post Ankle Sprain Balance and Proprioception in Adults: A Randomized Controlled Trial.,"Stretching is an important part of post ankle sprain rehabilitation, as well as an effective exercise for improving general ankle-joint performance. But the combination of stretching alongside low-frequency stimulation has not yet been extensively studied. Therefore, the purpose of the present randomized controlled trial was to compare the combined effects of low-frequency transcutaneous electrical nerve stimulation (TENS) with proprioceptive neuromuscular facilitation (PNF) on strength, balance, and proprioception among individuals with post ankle sprain. Sixty male subjects with lateral ankle sprain were selected and randomly allocated to three groups: group 1, group 2, and the control group (CG). Subjects in group 1 received the PNF stretching technique combined with TENS. TENS stimulation was provided using two electrodes placed 5 cm apart directly on the triceps sural muscle of the affected leg and a biphasic current with a symmetrical waveform at 50 Hz for 15 seconds, tuned for a 3-second ramp up time and a 30-second rest time with a 250-microsecond pulse duration was given with PNF stretching. Subjects in group 2 received the PNF stretching technique alone. Both group 1 and group 2 received these treatments for 4 weeks (4 days/week); follow-up assessments were administered in the third and fifth weeks. CG received no treatment; outcome measures alone were assessed. Outcome measures comprised pain, balance, flexibility, proprioception, range of motion, muscle strength, and functional limitation. A mixed-model ANOVA showed significant interaction (time and group) and the time effect for all the outcome measures ( p  ≤ 0.05). Group 1 (PNF-TENS) showed significant improvement for all the outcome variables compared to the other groups. The present study showed PNF stretching combined with TENS for the triceps sural muscle to trigger muscle contraction during the muscle contraction phase of the PNF stretch, compared against PNF stretching alone, produced significant improvements in ankle function for post ankle sprain subjects.",2020,"Outcome measures comprised pain, balance, flexibility, proprioception, range of motion, muscle strength, and functional limitation.","['individuals with post ankle sprain', 'Adults', 'Sixty male subjects with lateral ankle sprain']","['PNF stretching combined with TENS', 'low-frequency transcutaneous electrical nerve stimulation (TENS) with proprioceptive neuromuscular facilitation (PNF', 'PNF stretching technique alone', 'PNF stretching technique combined with TENS', 'Low-Frequency Stimulation']","['strength, balance, and proprioception', 'ankle function', 'pain, balance, flexibility, proprioception, range of motion, muscle strength, and functional limitation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C1720874', 'cui_str': 'Proprioceptive Neuromuscular Facilitation (PNF) Stretching'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",60.0,0.0488455,"Outcome measures comprised pain, balance, flexibility, proprioception, range of motion, muscle strength, and functional limitation.","[{'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alahmari', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Silvian', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ravi Shankar', 'Initials': 'RS', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Jaya Shanker', 'Initials': 'JS', 'LastName': 'Tedla', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Venkata Nagaraj', 'Initials': 'VN', 'LastName': 'Kakaraparthi', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Kanagaraj', 'Initials': 'K', 'LastName': 'Rengaramanujam', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}]",BioMed research international,['10.1155/2020/9012930']
2925,33029552,"Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.","Background


Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high  sn -2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance.
Methods


In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days. Primary endpoint was daily duration of fussiness-crying. Secondary endpoints included gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety.
Results


Mean ± SE minutes/day of fussiness-crying in the 256 analyzed infants (FA, n = 127 and FB, n = 129) substantially decreased from baseline to study end in FA (291 ± 14 to 140 ± 8; -52%,  P  < .001), and FB (313 ± 14 to 153 ± 11, -51%,  P  < .001) with no difference between groups. Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas. Mean ± SE IGSQ index scores significantly decreased from baseline to study end (FA: 44.5 ± 0.9 to 28.6 ± 0.7; FB: 44.5 ± 0.8 to 29.0 ± 0.7;  P  < .001) with no differences between groups. Infant temperament and maternal anxiety also improved significantly in both groups by study end.
Conclusion


Switching from standard, full-lactose, intact whey/casein infant formulas to either study formula resulted in an improvement of gastrointestinal symptoms and associated behaviors in infants with signs of feeding intolerance.
Trial Registration


https://clinicaltrials.gov, NCT02021058.",2020,"Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas.","['healthy full-term infants with parent-reported signs of feeding intolerance', '6 Asian study centers, exclusively formula-fed infants aged 30 to 90\u2009days, whose parents reported fussiness-crying for ≥2\u2009hours/day plus gassiness and/or stooling difficulty, and intended to switch formula', 'formula-fed infants', 'infants with signs of feeding intolerance', 'Infants with Parent-Reported Signs of Formula Intolerance']","['FA', 'FB', 'partially hydrolyzed 100% whey protein formula with high  sn -2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB']","['gastrointestinal symptoms and associated behaviors', 'Mean\u2009±\u2009SE IGSQ index scores', 'Infant temperament and maternal anxiety', 'gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety', 'daily duration of fussiness-crying', 'Results\n\n\nMean\u2009±\u2009SE minutes/day of fussiness-crying', 'gassiness, spitting-up, vomiting and sleep pattern']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0002287', 'cui_str': 'Alpha-lactalbumin'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}]",6.0,0.325478,"Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas.","[{'ForeName': 'Boosba', 'Initials': 'B', 'LastName': 'Vivatvakin', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Estorninos', 'Affiliation': 'Asian Hospital and Medical Center, Muntinlupa City, Philippines.'}, {'ForeName': 'Reyin', 'Initials': 'R', 'LastName': 'Lien', 'Affiliation': 'Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Hung Chang', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kam Lun Ellis', 'Initials': 'KLE', 'LastName': 'Hon', 'Affiliation': 'The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Jowena', 'Initials': 'J', 'LastName': 'Lebumfacil', 'Affiliation': 'Wyeth Nutrition, Makati City, Manila, Philippines.'}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Cercamondi', 'Affiliation': 'Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Volger', 'Affiliation': 'Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.'}]",Global pediatric health,['10.1177/2333794X20954332']
2926,33029578,Variable Magnitude and Frequency Financial Reinforcement is Effective at Increasing Adults' Free-Living Physical Activity.,"Financial rewards can increase health behaviors, but little research has quantified the effects of different reinforcement schedules on this process. This analysis compares the average moderate-to-vigorous physical activity (MVPA) associated with six distinct positive reinforcement schedules implemented within a physical activity promotion clinical trial. In this trial, participants ( N  = 512) wore an accelerometer for 1 year and were prescribed one of two types of MVPA goals: a static 30-min goal or an adaptive goal based on the MVPA produced over the previous 9 days. As participants met goals, they transitioned through a sequence of reinforcement stages, beginning with a continuous-fixed magnitude (CRF-FM), then CRF-variable magnitude (CRF-VM), followed by a series of variable ratio-VM (VR-VM) schedules. The average accumulation of MVPA bouts over the last 24 days of each stage was compared to each other. Average MVPA during stage transitions was also examined. The results indicated that immediate reinforcement resulted in more MVPA relative to a comparison group and that the relative effectiveness of adaptive versus static goals was dependent on the magnitude of daily MVPA goals. Schedule effects were qualitatively different for individuals who frequently met their daily goals (Large Intervention Effect subgroup) versus those who did not (Small Intervention Effect subgroup). For the Large Intervention Effect group, the CRF-VM schedule produced the most MVPA, in particular within the adaptive goal condition, with increases observed immediately upon encountering this schedule. In contrast, the CRF-FM schedule produced small amounts of MVPA. This pattern was reversed for the Small Intervention Effect subgroup, where the most MVPA was associated with the CRF-FM stage. Future interventions should focus on discriminating small versus large intervention effects as quickly as possible so that the optimal reinforcement schedule can be used.",2020,Schedule effects were qualitatively different for individuals who frequently met their daily goals (Large Intervention Effect subgroup) versus those who did not (Small Intervention Effect subgroup).,['participants ( N  = 512'],[],"['health behaviors', 'MVPA relative', 'average accumulation of MVPA bouts']",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0417743,Schedule effects were qualitatively different for individuals who frequently met their daily goals (Large Intervention Effect subgroup) versus those who did not (Small Intervention Effect subgroup).,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Berardi', 'Affiliation': 'Department of Psychology, Chapman University, Orange, CA USA.'}, {'ForeName': 'Melbourne', 'Initials': 'M', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, San Diego State University, San Diego, CA USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Hurley', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ USA.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Phillips', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bellettiere', 'Affiliation': 'Family Medicine and Public Health, University of California, San Diego, CA USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ USA.'}]",Perspectives on behavior science,['10.1007/s40614-019-00241-y']
2927,33029645,Direct Evidence for Crossover and Chromatid Interference in Meiosis of Two Plant Hybrids (Lolium Multiflorum × Festuca Pratensis And Allium Cepa × A. Roylei).,"Crossing over, apart from its strictly genetic role, also performs a critical mechanical function, by bonding homologues in meiosis. Hence, it is responsible for an orderly reduction of the chromosome number. As such, it is strictly controlled in frequency and distribution. The well-known crossover control is the positive crossover interference which reduces the probability of a crossover in the vicinity of an already formed crossover. A poorly studied aspect of the control is the chromatid interference. Such analyses are possible in very few organisms as they require observation of all four products of a single meiosis. Here, we provide direct evidence of chromatid interference. Using in situ probing in two interspecific plant hybrids (Lolium multiflorum × Festuca pratensis and Allium cepa × A. roylei) during anaphase I, we demonstrate that the involvement of four chromatids in double crossovers is significantly more frequent than expected (64% vs. 25%). We also provide a physical measure of the crossover interference distance, covering ca. 30-40% of the relative chromosome arm length, and show that the centromere acts as a barrier for crossover interference. The two arms of a chromosome appear to act as independent units in the process of crossing over. Chromatid interference has to be seriously addressed in genetic mapping approaches and further studies.",2020,Using in situ probing in two interspecific plant hybrids (Lolium multiflorum × Festuca pratensis and Allium cepa × A. roylei) during anaphase,['Meiosis of Two Plant Hybrids '],[],[],"[{'cui': 'C0025186', 'cui_str': 'Meiosis'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]",[],[],,0.0542433,Using in situ probing in two interspecific plant hybrids (Lolium multiflorum × Festuca pratensis and Allium cepa × A. roylei) during anaphase,"[{'ForeName': 'Marco Tulio Mendes', 'Initials': 'MTM', 'LastName': 'Ferreira', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Glombik', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}, {'ForeName': 'Kateřina', 'Initials': 'K', 'LastName': 'Perničková', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Duchoslav', 'Affiliation': 'Department of Botany, Faculty of Science, Palacký University, Olomouc, Czech Republic.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Scholten', 'Affiliation': 'Plant Breeding, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Karafiátová', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}, {'ForeName': 'Vania Helena', 'Initials': 'VH', 'LastName': 'Techio', 'Affiliation': 'Department of Biology, Federal University of Lavras, Lavras-MG, Brazil.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Doležel', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Lukaszewski', 'Affiliation': 'Department of Botany and Plant Sciences, University of California, Riverside, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kopecký', 'Affiliation': 'Institute of Experimental Botany, Czech Acad. Sci., Centre of the Region Haná for Biotechnological and Agricultural Research, Olomouc, Czech Republic.'}]",Journal of experimental botany,['10.1093/jxb/eraa455']
2928,33025927,Effectiveness of Toothpaste Containing REFIX Technology against Dentin Hypersensitivity: A Randomized Clinical Study.,"AIM


This clinical study aimed to evaluate the efficacy of a toothpaste containing a proprietary REFIX technology (Regenerador + Sensitive DentalClean, Rabbit Corp) against dentin hypersensitivity.
MATERIALS AND METHODS


Fifty-three volunteers who fulfilled the inclusion criteria and signed the consent form were included. They were examined for dentin hypersensitivity. The participants received a 1-second blast of air, and the tooth sensitivity, from 0 to 10, was immediately evaluated using a visual analog scale (VAS). Then, the participants brushed their teeth with the multifunctional toothpaste, and dentin hypersensitivity was tested a second time using the same scale. The participants continued to use the toothpaste three times a day for 1 week, after which dentin hypersensitivity was recorded for the third time. Data were statistically analyzed using analysis of variance (ANOVA) and Tukey's test ( α  = 0.05).
RESULTS


The mean patient age was 40 years, and 70% of the 53 subjects were female. There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week. The baseline mean patient-reported pain score was severe (6.5 ± 2.4). Immediately after the first use of the toothpaste, the mean reported pain significantly decreased to mild pain (2.5 ± 2.5) ( p  < 0.05). After 1 week of consistent use of the toothpaste, the pain score reduced significantly (0.7 ± 1.2) ( p  < 0.05), and most participants reported no pain, demonstrating the effectiveness of the REFIX technology against dentin hypersensitivity.
CONCLUSION


This clinical trial shows that the use of the phosphate-based desensitizing toothpaste containing REFIX technology significantly reduces dentin hypersensitivity after 1 week of consistent use.
CLINICAL SIGNIFICANCE


The absence of pain, a desired clinical condition in patients with dentin hypersensitivity, was reached with the use of desensitizing toothpaste containing REFIX technology after 1 week of use. Such condition positively impacts quality of life, providing a healthier daily routine for patients.",2020,There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week.,"['Fifty-three volunteers who fulfilled the inclusion criteria and signed the consent form were included', 'patients with dentin hypersensitivity', 'against Dentin Hypersensitivity', 'mean patient age was 40 years, and 70% of the 53 subjects were female', 'patients']","['toothpaste containing a proprietary REFIX technology (Regenerador + Sensitive DentalClean, Rabbit Corp', 'Toothpaste Containing REFIX Technology']","['visual analog scale (VAS', 'pain score', 'mild pain', 'dentin hypersensitivity']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]",53.0,0.033617,There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week.,"[{'ForeName': 'Fabiano V', 'Initials': 'FV', 'LastName': 'Vilhena', 'Affiliation': 'Trials, Research and Development, Inc.'}, {'ForeName': 'Mackeler R', 'Initials': 'MR', 'LastName': 'Polassi', 'Affiliation': 'Biotechnology and Innovation in Health Program, Anhanguera University of São Paulo (UNIAN-SP), São Paulo, Brazil.'}, {'ForeName': 'Eloisa Ac', 'Initials': 'EA', 'LastName': 'Paloco', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University North of Paraná-UNOPAR, Londrina, Paraná, Brazil.'}, {'ForeName': 'Roberta Cb', 'Initials': 'RC', 'LastName': 'Alonso', 'Affiliation': 'Department of Dentistry, School of Dentistry, Metropolitan University of Santos, Santos, São Paulo, Brazil; University of Mogi das Cruzes, Mogi das Cruzes, São Paulo, Brazil.'}, {'ForeName': 'Ricardo D', 'Initials': 'RD', 'LastName': 'Guiraldo', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University North of Paraná-UNOPAR, Londrina, Paraná, Brazil.'}, {'ForeName': 'Paulo Hp', 'Initials': 'PH', 'LastName': ""D'Alpino"", 'Affiliation': 'Biotechnology and Innovation in Health Program, Anhanguera University of São Paulo (UNIAN-SP), São Paulo, Brazil, Phone: +55 11 35128412, e-mail: paulodalpino@gmail.com.'}]",The journal of contemporary dental practice,[]
2929,32492135,"Mediterranean diet, Dietary Approaches to Stop Hypertension, and Pro-vegetarian dietary pattern in relation to the risk of basal cell carcinoma: a nested case-control study within the Seguimiento Universidad de Navarra (SUN) cohort.","BACKGROUND


The association of dietary pattern with the risk of basal cell carcinoma (BCC) is little understood and has scarcely been investigated.
OBJECTIVES


We assessed the association of several complete dietary patterns [Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Pro-vegetarian dietary pattern] with the risk of BCC, conducting a nested case-control study (4 controls for each case).
METHODS


Cases and controls were selected from the SUN (Seguimiento Universidad de Navarra) cohort using risk set sampling. Cases were identified among subjects free of skin cancer at baseline but who later reported a physician-made BCC diagnosis during the follow-up period. In the cohort we identified 101 incident cases of BCC.
RESULTS


In multivariable-adjusted conditional logistic regression analyses, better adherence to the Mediterranean diet (highest compared with lowest quintile) was associated with a 72% relative reduction in the odds of BCC (OR: 0.28; 95% CI: 0.10, 0.77; Ptrend = 0.014); the DASH diet was associated with a 68% RR reduction (OR: 0.32; 95% CI: 0.14, 0.76; Ptrend = 0.013) for the comparison between extreme quintiles. No association was found between a Pro-vegetarian dietary pattern and BCC. Higher fruit consumption (highest compared with lowest quintile, OR: 0.27; 95% CI: 0.11, 0.64; Ptrend < 0.001) and low-fat dairy products (OR: 0.39; 95% CI: 0.16, 0.92; Ptrend = 0.014) were associated with a lower BCC risk.
CONCLUSIONS


Our results suggest that Mediterranean and DASH dietary patterns may be associated with a lower risk of BCC, but confirmatory studies are required.",2020,"Higher fruit consumption (highest compared with lowest quintile, OR: 0.27; 95% CI: 0.11, 0.64; Ptrend < 0.001) and low-fat dairy products (OR: 0.39; 95% CI: 0.16, 0.92; Ptrend = 0.014) were associated with a lower BCC risk.
",['Cases and controls were selected from the SUN (Seguimiento Universidad de Navarra) cohort using risk set sampling'],"['Mediterranean diet, Dietary Approaches to Stop Hypertension, and Pro-vegetarian dietary pattern']",['Higher fruit consumption'],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0221305,"Higher fruit consumption (highest compared with lowest quintile, OR: 0.27; 95% CI: 0.11, 0.64; Ptrend < 0.001) and low-fat dairy products (OR: 0.39; 95% CI: 0.16, 0.92; Ptrend = 0.014) were associated with a lower BCC risk.
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Leone', 'Affiliation': 'International Center for the Assessment of Nutritional Status, Department of Food, Environmental and Nutritional Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martin-Gorgojo', 'Affiliation': 'Dermatology & Venereology Department, ""Madrid Salud"" Regional Healthcare Agency, Madrid City Council, Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Sánchez-Bayona', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'De Amicis', 'Affiliation': 'International Center for the Assessment of Nutritional Status, Department of Food, Environmental and Nutritional Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bertoli', 'Affiliation': 'International Center for the Assessment of Nutritional Status, Department of Food, Environmental and Nutritional Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Battezzati', 'Affiliation': 'International Center for the Assessment of Nutritional Status, Department of Food, Environmental and Nutritional Sciences, University of Milan, Milan, Italy.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Bes-Rastrollo', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Navarra, Pamplona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa127']
2930,31084260,Effects of personalized endurance training on cellular age and vascular function in middle-aged sedentary women.,,2019,,['middle-aged sedentary women'],['personalized endurance training'],['cellular age and vascular function'],"[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.0640581,,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Eigendorf', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Melk', 'Affiliation': 'Department of Paediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Boethig', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Berliner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kueck', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}, {'ForeName': 'Hedwig', 'Initials': 'H', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Department of Prosthetic Dentistry and Biomedical Material Sciences, Hannover Medical School, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Schippert', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hannover Medical School, Germany.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Hilfiker', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Falk', 'Affiliation': 'Institute of Transplant Immunology, Hannover Medical School, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Thum', 'Affiliation': 'Institute for Molecular and Translational Therapeutic Strategies (IMTTS), Hannover Medical School, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lichtinghagen', 'Affiliation': 'Institute for Clinical Chemistry, Hannover Medical School, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': 'Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, Germany.'}]",European journal of preventive cardiology,['10.1177/2047487319849505']
2931,31169550,Investigating the Causal Mechanisms of Symptom Recovery in Chronic Whiplash-associated Disorders Using Bayesian Networks.,"OBJECTIVES


The present study's objective was to understand the causal mechanisms underpinning the recovery of individuals with whiplash-associated disorders (WAD). We applied Bayesian Networks (BN) to answer 2 study aims: (1) to identify the causal mechanism(s) of recovery underpinning neck-specific exercise (NSE), and (2) quantify if the cyclical pathway of the fear-avoidance model (FAM) is supported by the present data.
MATERIALS AND METHODS


We analyzed a prospective cohort data set of 216 individuals with chronic WAD. Fifteen variables were used to build a BN model: treatment group (NSE with or without a behavioral approach, or general physical activity), muscle endurance, range of motion, hand strength, neck proprioception, pain catastrophizing, fear, anxiety, depression, self-efficacy, perceived work ability, disability, pain intensity, sex, and follow-up time.
RESULTS


The BN model showed that neck pain reduction rate was greater after NSE compared with physical activity prescription (β=0.59 points per month [P<0.001]) only in the presence of 2 mediators: global neck muscle endurance and perceived work ability. We also found the following pathway of variables that constituted the FAM: anxiety, followed by depressive symptoms, fear, catastrophizing, self-efficacy, and consequently pain.
CONCLUSIONS


We uncovered 2 mediators that explained the mechanisms of effect behind NSE, and proposed an alternative FAM pathway. The present study is the first to apply BN modelling to understand the causal mechanisms of recovery in WAD. In doing so, it is anticipated that such analytical methods could increase the precision of treatment of individuals with chronic WAD.",2019,The BN model showed that neck pain reduction rate was greater after NSE compared with physical activity prescription (β=0.59 points per month [P<0.001]) only in the presence of 2 mediators: global neck muscle endurance and perceived work ability.,"['individuals with whiplash-associated disorders (WAD', 'individuals with chronic WAD', '216 individuals with chronic WAD']","['NSE', 'recovery underpinning neck-specific exercise (NSE', 'BN model: treatment group (NSE with or without a behavioral approach, or general physical activity']","['neck pain reduction rate', 'muscle endurance, range of motion, hand strength, neck proprioception, pain catastrophizing, fear, anxiety, depression, self-efficacy, perceived work ability, disability, pain intensity, sex, and follow-up time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4708905', 'cui_str': '216'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0206724,The BN model showed that neck pain reduction rate was greater after NSE compared with physical activity prescription (β=0.59 points per month [P<0.001]) only in the presence of 2 mediators: global neck muscle endurance and perceived work ability.,"[{'ForeName': 'Bernard X W', 'Initials': 'BXW', 'LastName': 'Liew', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scutari', 'Affiliation': 'Department of Statistics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Peterson', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ludvigsson', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, Linköping.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Falla', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000728']
2932,31423722,Achievement of glycaemic control is associated with improvements in lipid profile with iGlarLixi versus iGlar: A post hoc analysis of the LixiLan-L trial.,"Diabetic dyslipidaemia is a major risk factor for accelerated atherosclerosis. Glycaemic treatments that improve dyslipidaemia may help reduce the burden of atherosclerosis. This analysis investigated the effect of iGlarLixi [insulin glargine U100 (iGlar) and lixisenatide] versus iGlar on lipid profiles in patients with type 2 diabetes uncontrolled on basal insulin. Data from LixiLan-L were used to estimate changes in fasting lipid levels from baseline to week 30, overall and in patients stratified by achievement of glycaemic targets {2-hour postprandial glucose [≤10, >10 mmoL/L], fasting plasma glucose [≤6.1, >6.1 mmoL/L], HbA1c [≤7, >7% (≤53, >53 mmol/mol)]}. At week 30, median percentage change in triglycerides remained nearly unchanged (0.3% increase) with iGlarLixi versus a 6.5% increase with iGlar (P = 0.035; overall); similarly, trends towards better total and LDL cholesterol levels were observed with iGlarLixi versus iGlar. In patient subgroups achieving glycaemic targets, all lipid variables except for HDL cholesterol improved with iGlarLixi but not with iGlar. In summary, patients with type 2 diabetes uncontrolled on basal insulin showed improved fasting lipid profiles with iGlarLixi compared with iGlar, particularly when achieving glycaemic targets.",2019,"In patient subgroups achieving glycaemic targets, all lipid variables except for HDL cholesterol improved with iGlarLixi but not with iGlar.",['patients with type 2 diabetes uncontrolled on basal insulin'],"['iGlarLixi [insulin glargine U100 (iGlar) and lixisenatide', 'iGlarLixi versus iGlar', 'iGlarLixi']","['burden of atherosclerosis', 'HDL cholesterol', 'fasting lipid levels', 'median percentage change in triglycerides', 'total and LDL cholesterol levels', 'fasting plasma glucose', 'fasting lipid profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile'}]",,0.0345225,"In patient subgroups achieving glycaemic targets, all lipid variables except for HDL cholesterol improved with iGlarLixi but not with iGlar.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Alka', 'Initials': 'A', 'LastName': 'Shaunik', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Aramesh', 'Initials': 'A', 'LastName': 'Saremi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13857']
2933,30873586,Depletion manipulations decrease openness to dissent via increased anger.,"We investigated a potential outcome of ego depletion manipulations and an important factor behind cooperative failure: a lack of openness to others' dissenting opinions. Across five studies in a variety of task settings, we examined the effect of depletion manipulations on openness to dissent and investigated two negative emotions as potential mediators of this process: fatigue and anger. The results demonstrated a negative effect of depletion manipulations on openness to dissent through increased anger rather than fatigue (Studies 1-5). In Studies 3 and 4, we also eliminated perceived trust towards a task counterpart as a significant mediator of the relationship between depletion manipulations and openness to dissent. These findings help clarify the nature of ego depletion manipulations and shed light on why individuals may fail to consider others' dissenting opinions and, thus, fall short of achieving cooperation.",2020,The results demonstrated a negative effect of depletion manipulations on openness to dissent through increased anger rather than fatigue (Studies 1-5).,[],[],[],[],[],[],,0.0288408,The results demonstrated a negative effect of depletion manipulations on openness to dissent through increased anger rather than fatigue (Studies 1-5).,"[{'ForeName': 'Ming-Hong', 'Initials': 'MH', 'LastName': 'Tsai', 'Affiliation': 'School of Social Sciences, Singapore Management University, Singapore.'}, {'ForeName': 'Norman P', 'Initials': 'NP', 'LastName': 'Li', 'Affiliation': 'School of Social Sciences, Singapore Management University, Singapore.'}]","British journal of psychology (London, England : 1953)",['10.1111/bjop.12387']
2934,32957318,Equimolar doses of hypertonic agents (saline or mannitol) in the treatment of intracranial hypertension after severe traumatic brain injury.,"BACKGROUND


Mannitol and hypertonic saline (HTS) are effective in reducing intracranial pressure (ICP) after severe traumatic brain injury (TBI). However, their efficacy on the ICP has not been evaluated rigorously.
OBJECTIVE


To evaluate the efficacy of repeated bolus dosing of HTS and mannitol in similar osmotic burdens to treat intracranial hypertension (ICH) in patients with severe TBI.
METHODS


The authors used an alternating treatment protocol to evaluate the efficacy of HTS with that of mannitol given for ICH episodes in patients treated for severe TBI at their hospital during 2017 to 2019. Doses of similar osmotic burdens (20% mannitol, 2 ml/kg, or 10% HTS, 0.63 ml/kg, administered as a bolus via a central venous catheter, infused over 15 minutes) were given alternately to the individual patient with severe TBI during ICH episodes. The choice of osmotic agents for the treatment of the initial ICH episode was determined on a randomized basis; osmotic agents were alternated for every subsequent ICH episode in each individual patient. intracranial pressure (ICP), mean arterial pressure (MAP), and cerebral perfusion pressure (CPP) were continuously monitored between the beginning of each osmotherapy and the return of ICP to 20 mm Hg. The duration of the effect of ICP reduction (between the beginning of osmotherapy and the return of ICP to 20 mm Hg), the maximum reduction of ICP and its time was recorded after each dose. Serum sodium and plasma osmolality were measured before, 0.5 hours and 3 hours after each dose. Adverse effects such as central pontine myelinolysis (CPM), severe fluctuations of serum sodium and plasma osmolality were assessed to evaluate the safety of repeated dosing of HTS and mannitol.
RESULTS


Eighty three patients with severe TBI were assessed, including 437 ICH episodes, receiving 236 doses of HTS and 221 doses of mannitol totally. There was no significant difference between equimolar HTS and mannitol boluses on the magnitude of ICP reduction, the duration of effect, and the time to lowest ICP achieved (P > .05). The proportion of efficacious boluses was higher for HTS than for mannitol (P = .016), as was the increase in serum sodium (P = .038). The serum osmolality increased immediately after osmotherapy with a significant difference (P = .017). No cases of CPM were detected.
CONCLUSION


Repeat bolus dosing of 10% HTS and 20% mannitol appears to be significantly and similarly effective for treating ICH in patients with severe TBI. The proportion of efficacious doses of HTS on ICP reduction may be higher than mannitol.",2020,"The proportion of efficacious boluses was higher for HTS than for mannitol (P = .016), as was the increase in serum sodium (P = .038).","['intracranial hypertension after severe traumatic brain injury', 'Eighty', 'patients with severe TBI', 'patients treated for severe TBI at their hospital during 2017 to 2019']","['HTS', 'mannitol', 'HTS and mannitol', 'Mannitol and hypertonic saline (HTS', 'hypertonic agents (saline or mannitol']","['ICP reduction, the duration of effect, and the time to lowest ICP', 'maximum reduction of ICP and its time', 'serum osmolality', 'intracranial pressure (ICP', 'ICP reduction', 'central pontine myelinolysis (CPM), severe fluctuations of serum sodium and plasma osmolality', 'serum sodium', 'Serum sodium and plasma osmolality', 'intracranial pressure (ICP), mean arterial pressure (MAP), and cerebral perfusion pressure (CPP', 'proportion of efficacious boluses']","[{'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456892', 'cui_str': 'Low intracranial pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum'}, {'cui': 'C0206083', 'cui_str': 'Central pontine myelinolysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}]",83.0,0.0729816,"The proportion of efficacious boluses was higher for HTS than for mannitol (P = .016), as was the increase in serum sodium (P = .038).","[{'ForeName': 'Xuecai', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Lishui Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Health examination center, Lishui Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Neurosurgery, Lishui Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Shike', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Neurosurgery, Lishui Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Baoping', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Lishui Hospital, Zhejiang University School of Medicine.'}]",Medicine,['10.1097/MD.0000000000022004']
2935,32986302,Lung ultrasound score and diuretics in preterm infants born before 32 weeks: A pilot study.,"OBJECTIVE


To describe if weekly determined lung ultrasound (LU) scores in preterm infants born before 32 weeks (PTB32W) change with diuretic therapy.
DESIGN


We included infants who received diuretics and compared LU scores according to their evolution on respiratory support (RS) before and after diuretics.
RESULTS


We included 18 PTB32W divided into two groups. Both groups were similar in terms of median gestational age: 26 weeks (interquartile range [IQR]: 25-28) in the responders' group and 27 weeks (IQR: 24-28) in the other. They differed, however, in the median number of days on invasive mechanical ventilation: 27 (IQR: 11-43) versus 76 (IQR: 35-117), p = .03; in addition to the number of infants with moderate-severe bronchopulmonary dysplasia: 3 (33%) versus 8 (89%), p = .025. The responders' group showed lower LU scores 2 days after diuretics, with a median LU score of 6 (IQR: 3-12) versus 14 (IQR: 12-17) in the nonresponders group, p = .03; 1 week after (3 [IQR: 0-10] versus 12 [12-12], p = .04); and 3 weeks after (5 [IQR: 3-6] versus 12 [10-15], p = .01). RS also decreased at the same time: 7 out of 9 (78%) were extubated in the responders' group, and 1 out of 9 (11%) in the nonresponders group, p = .02, and these differences remained throughout the entire follow-up.
CONCLUSIONS


There is a group of PTB32W patients whose LU score improves after diuretics. This change appears only in those patients that can be weaned off from RS, and at the same period of time as the administration of diuretics.",2020,Both groups were similar in terms of median gestational age: 26 weeks (interquartile range [IQR]: 25-28) in the responders' group and 27 weeks (IQR: 24-28) in the other.,"['preterm infants born before 32 weeks (PTB32W) change with diuretic therapy', 'infants who received diuretics and compared LU scores according to their evolution on respiratory support (RS) before and after diuretics', 'preterm infants born before 32 weeks']",[],"['lower LU scores', 'LU score', 'lung ultrasound (LU) scores', 'Lung ultrasound score and diuretics', 'median number of days on invasive mechanical ventilation']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]",,0.0464594,Both groups were similar in terms of median gestational age: 26 weeks (interquartile range [IQR]: 25-28) in the responders' group and 27 weeks (IQR: 24-28) in the other.,"[{'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Alonso-Ojembarrena', 'Affiliation': 'Neonatal Intensive Care Unit, Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Alfonso María', 'Initials': 'AM', 'LastName': 'Lechuga-Sancho', 'Affiliation': 'Research Unit, Biomedical Research and Innovation Institute of Cádiz (INiBICA), Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Morales-Arandojo', 'Affiliation': 'Research Unit, Biomedical Research and Innovation Institute of Cádiz (INiBICA), Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Acuñas-Soto', 'Affiliation': 'Research Unit, Biomedical Research and Innovation Institute of Cádiz (INiBICA), Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'López-de-Francisco', 'Affiliation': 'Research Unit, Biomedical Research and Innovation Institute of Cádiz (INiBICA), Puerta del Mar University Hospital, Cádiz, Spain.'}, {'ForeName': 'Simón Pedro', 'Initials': 'SP', 'LastName': 'Lubián-López', 'Affiliation': 'Neonatal Intensive Care Unit, Puerta del Mar University Hospital, Cádiz, Spain.'}]",Pediatric pulmonology,['10.1002/ppul.25098']
2936,32988903,Treatment of Patients With Non-small-cell Lung Cancer With Uncommon  EGFR  Mutations in Clinical Practice.,"BACKGROUND/AIM


To describe real clinical outcomes in patients with non-small cell lung cancer who have uncommon epidermal growth factor receptor (EGFR) mutations.
MATERIALS AND METHODS


We performed a retrospective chart review from 15 medical institutes that cover a population of three million people from April 2008 to March 2019.
RESULTS


There were 102 patients with uncommon EGFR mutation. Progression-free survival (PFS) tended to be longer in patients receiving afatinib compared with first-generation EGFR tyrosine kinase inhibitors. PFS in patients treated with afatinib or osimertinib was significantly longer than in patients treated with gefitinib or erlotinib (p=0.030). Multivariate analysis also revealed the contribution of afatinib or osimertinib to increased survival. In patients with exon 20 insertions, chemotherapy was efficacious.
CONCLUSION


In treating patients with uncommon EGFR mutations, our results indicate longer-term survival might be achieved with second-generation or later TKIs and cytotoxic chemotherapeutic drugs.",2020,PFS in patients treated with afatinib or osimertinib was significantly longer than in patients treated with gefitinib or erlotinib (p=0.030).,"['patients with non-small cell lung cancer who have uncommon epidermal growth factor receptor (EGFR) mutations', 'Patients With Non-small-cell Lung Cancer With Uncommon  EGFR', '102 patients with uncommon EGFR mutation', 'We performed a retrospective chart review from 15 medical institutes that cover a population of three million people from April 2008 to March 2019', 'patients with uncommon EGFR mutations']",['gefitinib or erlotinib'],"['Progression-free survival (PFS', 'survival', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4517701', 'cui_str': '3000000'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",102.0,0.0476417,PFS in patients treated with afatinib or osimertinib was significantly longer than in patients treated with gefitinib or erlotinib (p=0.030).,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan tamura-tuk@umin.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Hitachi General Hospital, Hitachi, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Ichimura', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Hitachi General Hospital, Hitachi, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hayashihara', 'Affiliation': 'Division of Respiratory Medicine, Ibarakihigashi Hospital, Tokai, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Division of Respiratory Medicine, Ibarakihigashi Hospital, Tokai, Japan.'}, {'ForeName': 'Hideyasu', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Division of Respiratory Medicine, Hitachinaka General Hospital-Hitachinaka Medical Center, University of Tsukuba, Hitachinaka, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Inage', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Satoh', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Mito Kyodo General Hospital-Mito Medical Center, University of Tsukuba, Mito, Japan.'}, {'ForeName': 'Kesato', 'Initials': 'K', 'LastName': 'Iguchi', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Mito Kyodo General Hospital-Mito Medical Center, University of Tsukuba, Mito, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kikuchi', 'Affiliation': 'Division of Respiratory Medicine, Kasumigaura Medical Center Hospital, Tsuchiura, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kurishima', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Tsukuba Medical Center Hospital, Tsukuba, Japan.'}, {'ForeName': 'Hiroichi', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Tsukuba Medical Center Hospital, Tsukuba, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Divisions of Respiratory Medicine and Thoracic Surgery, Tsukuba Medical Center Hospital, Tsukuba, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Division of Respiratory Medicine, Tsukuba Memorial Hospital, Tsukuba, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Shiozawa', 'Affiliation': 'Faculty of Clinical Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Hizawa', 'Affiliation': 'Faculty of Clinical Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Sekine', 'Affiliation': 'Faculty of Clinical Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Faculty of Clinical Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Funayama', 'Affiliation': 'Division of Respiratory Medicine, Tsukuba Gakuen Hospital, Tsukuba, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Division of Respiratory Medicine, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Kodama', 'Affiliation': 'Division of Respiratory Medicine, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigen', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Division of Respiratory Medicine, Ibaraki Seinan Medical Center Hospital, Sakai, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nomura', 'Affiliation': 'Division of Respiratory Medicine, Ibaraki Seinan Medical Center Hospital, Sakai, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Division of Respiratory Medicine, Tokyo Medical University, Ibaraki Medical Center, Ami, Japan.'}, {'ForeName': 'Kinya', 'Initials': 'K', 'LastName': 'Furukawa', 'Affiliation': 'Division of Respiratory Medicine, Tokyo Medical University, Ibaraki Medical Center, Ami, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Division of Respiratory Medicine, JA Toride Medical Center Hospital, Toride, Japan.'}, {'ForeName': 'Hatsumi', 'Initials': 'H', 'LastName': 'Okubo', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan.'}, {'ForeName': 'Moriyuki', 'Initials': 'M', 'LastName': 'Kiyoshima', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kaburagi', 'Affiliation': 'Respiratory Center, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama, Japan.'}]",Anticancer research,['10.21873/anticanres.14592']
2937,32474159,The effect of tezepelumab on hospitalizations and emergency department visits in patients with severe asthma.,,2020,,['patients with severe asthma'],['tezepelumab'],['hospitalizations and emergency department visits'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C4550163', 'cui_str': 'tezepelumab'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",,0.0180415,,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles Los Angeles, California. Electronic address: jcorren@ucla.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Callan', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Esther Garcia', 'Initials': 'EG', 'LastName': 'Gil', 'Affiliation': 'Global Medical Affairs, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.020']
2938,32484870,Which Method of Assessing Depression and Anxiety Best Predicts Smoking Cessation: Screening Instruments or Self-Reported Conditions?,"INTRODUCTION


Affective disorders and symptoms (ADS) are predictive of lower odds of quitting smoking. However, it is unknown which approach to assessing ADS best predicts cessation. This study compared a battery of ADS screening instruments with a single, self-report question on predicting cessation. Among those who self-reported ADS, we also examined if an additional question regarding whether participants believed the condition(s) might interfere with their ability to quit added predictive utility to the single-item question.
METHODS


Participants (N = 2637) enrolled in a randomized controlled trial of web-based smoking treatments completed a battery of five ADS screening instruments and answered a single-item question about having ADS. Those with a positive self-report on the single-item question were also asked about their interference beliefs. The primary outcome was complete-case, self-reported 30-day point prevalence abstinence at 12 months.
RESULTS


Both assessment approaches significantly predicted cessation. Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001). Area under the receiver operating characteristic curve values for the two assessment approaches were similar (p = .136). Adding the interference belief question to the single-item assessment significantly increased the area under the receiver operating characteristic curve value (p = .042).
CONCLUSIONS


The single-item question assessing ADS had as much predictive validity, and possibly more, than the battery of screening instruments for identifying participants at risk for failing to quit smoking. Adding a question about interference beliefs significantly increased the predictive utility of the single-item question.
IMPLICATIONS


This is the first study to demonstrate that a single-item question assessing ADS has at least as much predictive validity, and possibly more, than a battery of validated screening instruments for identifying smokers at highest risk for cessation failure. This study also demonstrates adding a question about interference beliefs significantly adds to the predictive utility of a single, self-report question about mental health conditions. Findings from this study can be used to inform decisions regarding how to assess ADS in the context of tobacco treatment settings.",2020,Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001).,['Participants (N = 2637) enrolled in a randomized controlled trial of web-based smoking treatments completed a battery of five ADS screening instruments and answered a single-item question about having ADS'],[],"['Depression and Anxiety Best Predicts Smoking Cessation', 'complete-case, self-reported 30-day point prevalence abstinence']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",[],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",2637.0,0.0463385,Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001).,"[{'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'McClure', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa099']
2939,32817692,Gaining traction: Promising shifts in gender norms and intimate partner violence in the context of a community-based HIV prevention trial in South Africa.,"BACKGROUND


HIV and violence prevention programs increasingly seek to transform gender norms among participants, yet how to do so at the community level, and subsequent pathways to behavior change, remain poorly understood. We assessed shifts in endorsement of equitable gender norms, and intimate partner violence (IPV), during the three-year community-based trial of Tsima, an HIV 'treatment as prevention' intervention in rural South Africa.
METHODS


Cross-sectional household surveys were conducted with men and women ages 18-49 years, in 8 intervention and 7 control communities, at 2014-baseline (n = 1,149) and 2018-endline (n = 1,189). Endorsement of equitable gender norms was measured by the GEM Scale. Intent-to-treat analyses assessed intervention effects and change over time. Qualitative research with 59 community members and 38 staff examined the change process.
RESULTS


Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop. Regression analyses showed a 15% improvement in GEM Scale score over time, irrespective of the intervention, among men (p<0.001) and women (p<0.001). Younger women (ages 18-29) had a decreased odds of reporting IPV in intervention vs. control communities (aOR 0.53; p<0.05). Qualitative data suggest that gender norms shifts may be linked to increased media access (via satellite TV/smartphones) and consequent exposure to serial dramas modeling equitable relationships and negatively portraying violence. Tsima's couple communication/conflict resolution skills-building activities, eagerly received by intervention participants, appear to have further supported IPV reductions.
CONCLUSIONS


There was a population-level shift towards greater endorsement of equitable gender norms between 2014-2018, potentially linked with rapid escalation in media access. There was also an intervention effect on reported IPV among young women, likely owing to improved couple communication. Societal-level gender norm shifts may create enabling environments for interventions to find new traction for violence and HIV-related behavior change.",2020,Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop.,"['59 community members and 38 staff examined the change process', 'Cross-sectional household surveys were conducted with men and women ages 18-49 years, in 8 intervention and 7 control communities, at 2014-baseline (n = 1,149) and 2018-endline (n = 1,189', 'rural South Africa', 'Younger women (ages 18-29']",['Gaining traction'],"['GEM Scale score', 'endorsement of equitable gender norms, and intimate partner violence (IPV']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.0629505,Nearly two-thirds of men and half of women in intervention communities had heard of the intervention/seen the logo; half of these had attended a two-day workshop.,"[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Gottert', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pulerwitz', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Haberland', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Rhandzekile', 'Initials': 'R', 'LastName': 'Mathebula', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Dumisani', 'Initials': 'D', 'LastName': 'Rebombo', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Spielman', 'Affiliation': 'Population Council/Project SOAR, Washington, D.C., United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Aimée', 'Initials': 'A', 'LastName': 'Julien', 'Affiliation': 'Department of Epideiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Peacock', 'Affiliation': 'Sonke Gender Justice, Bushbuckridge Local Municipality, South Africa.'}, {'ForeName': 'Mi-Suk', 'Initials': 'MS', 'LastName': 'Kang Dufour', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gómez-Olivé', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epideiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Lippman', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",PloS one,['10.1371/journal.pone.0237084']
2940,30576258,Patient-Centered Methods for Designing and Developing Health Information Communication Technologies: A Systematic Review.,"Background:  Chronic disease management and maintaining healthy behaviors to prevent disease are important lifelong considerations. Adherence to prescribed management and behaviors often falls short of physician recommendations, which can result in negative health outcomes. Information communication technologies (ICTs) offer an approach to combat this issue. However, uptake and sustainability of ICTs have mixed results. One reason could be that technologies are often created without an understanding of the complexities of patient needs. Therefore, the intent of this study is to explore the current landscape of patient-centered design and development of health ICTs through a systematic review.   Materials and Methods:  Systematic literature searches were conducted in the databases EBSCO, PubMed, and Web of Science between October 2016 and February 2017. Each paper was critically evaluated for each data extraction classification, and was categorized based on the chronic disease or health focus, method of patient-centered design, resulting themes, and use of theory.   Results:  The study search resulted in 3,748 articles total. After duplicates and articles not meeting criteria were removed, 57 articles were selected for assessment. Four main themes emerged: participant experience, technological requirements, behavioral and knowledge components, and social components.   Conclusions:  Adhering to chronic disease management and healthy behaviors are both crucial to attain positive health outcomes. ICTs can play an interesting role in aiding disease management and healthy behavior promotion, but involving end-users and applying a theoretical foundation in the design and development of these technologies should be considered.",2019,"ICTs can play an interesting role in aiding disease management and healthy behavior promotion, but involving end-users and applying a theoretical foundation in the design and development of these technologies should be considered.","['3,748 articles total']",['Information communication technologies (ICTs'],"['participant experience, technological requirements, behavioral and knowledge components, and social components']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0377707,"ICTs can play an interesting role in aiding disease management and healthy behavior promotion, but involving end-users and applying a theoretical foundation in the design and development of these technologies should be considered.","[{'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Advertising and Public Relations, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Bree E', 'Initials': 'BE', 'LastName': 'Holtz', 'Affiliation': 'Department of Advertising and Public Relations, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'McCarroll', 'Affiliation': 'Department of Media and Information, Michigan State University, East Lansing, Michigan.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0236']
2941,31029475,Pain management after photorefractive keratectomy.,"PURPOSE


To evaluate the effect of a bandage contact lens soaked in ketorolac ophthalmic 0.45% solution (Acuvail) on pain modulation in patients having transepithelial photorefractive keratectomy (PRK).
DESIGN


Prospective case series.
SETTING


Narayana Nethralaya Superspeciality Eye Hospital, Bangalore, India.
METHODS


Eyes of patients were divided into 2 groups. After transepithelial PRK, a regular soft bandage contact lens was placed in Group 1 and a ketorolac-soaked bandage contact lens was placed in Group 2. The patients were matched for age and sex in the 2 groups. Postoperative pain was compared using the validated Wong-Baker pain scale. Before placement of a ketorolac-soaked bandage contact lens in patients' eyes, the safety of the procedure was checked using cultures from the bandage contact lens and measuring the quantity of the drug adsorbed and the elution profile over time with ultra-high-performance liquid chromatography (UHPLC).
RESULTS


Each group comprised 35 eyes of 35 patients. The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens. The UHPLC results showed that the soaked bandage contact lens acted as a depot for ketorolac, which was released onto the ocular surface over time, providing postoperative pain relief without causing adverse events.
CONCLUSION


A bandage contact lens soaked in ketorolac 0.45% solution can act as a potential drug depot that can reduce pain after transepithelial PRK.",2019,"The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens.","['Narayana Nethralaya Superspeciality Eye Hospital, Bangalore, India', 'patients having transepithelial photorefractive keratectomy (PRK', ""patients' eyes"", 'Eyes of patients were divided into 2 groups', 'Pain management after photorefractive keratectomy']","['ketorolac-soaked bandage contact lens', 'bandage contact lens soaked in ketorolac ophthalmic 0.45% solution (Acuvail']","['mean pain score', 'pain modulation', 'Postoperative pain']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0717876', 'cui_str': 'Ketorolac-containing product in ocular dose form'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2718635', 'cui_str': 'Acuvail'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",35.0,0.0235251,"The mean pain score was 7.95 ± 2.12 (SD) in Group 1, which was significantly higher than in Group 2 (2.76 ± 0.85), which received the ketorolac-soaked bandage contact lens.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Shetty', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Dalal', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Archana Padmanabhan', 'Initials': 'AP', 'LastName': 'Nair', 'Affiliation': 'GROW Research Laboratory, Narayana Nethralaya Foundation, Bangalore, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khamar', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': ""D'Souza"", 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India. Electronic address: drsharondsouza@gmail.com.'}, {'ForeName': 'Ravish', 'Initials': 'R', 'LastName': 'Vaishnav', 'Affiliation': 'Narayana Nethralaya Superspeciality Eye Hospital and the Postgraduate Institute of Ophthalmology, Bangalore, India.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.01.032']
2942,31222909,Adiposity measures and pre-diabetes or diabetes in adults with hypertension in Singapore polyclinics.,"Identification of hypertensive patients with pre-diabetes or diabetes is important for timely prevention of complications including vascular disease. We aimed to compare the association and discrimination of central obesity measures (waist circumference [WC] and waist-to-height ratio [WHtR]) with generalized obesity measure (body mass index [BMI]) in relation to pre-diabetes and diabetes among a group of Asian hypertensive patients for the first time. We used the baseline data of 925 subjects aged 40 years or older with uncontrolled hypertension recruited at eight primary care clinics in Singapore. Information on height, weight, WC, fasting blood glucose, and hemoglobin A1c (HbA1c) was collected. Pre-diabetes or diabetes was defined as having reported physician-diagnosed diabetes or taking anti-diabetes medication, fasting blood glucose ≥ 5.6 mmol/dL or HbA1c ≥ 5.7%. Among 925 subjects, 495 (53.5%) had pre-diabetes or diabetes. In logistic regression models, BMI was not associated with pre-diabetes or diabetes after adjusting for WC or WHtR, while a positive association remained with both WC and WHtR after adjustment of BMI. Both WC and WHtR had significantly better discrimination than BMI (respective area under ROC curve: 0.63 for WC, 0.63 for WHtR, and 0.60 for BMI; P = 0.019), and adding WC or WHtR on top of BMI further correctly reclassified 42.7% and 38.7% hypertensive patients to the right risk group of pre-diabetes or diabetes indicated by net reclassification improvement. However, WHtR was not superior to WC. In conclusion, our results suggested that central obesity has stronger association with and better discrimination for pre-diabetes or diabetes than generalized obesity.",2019,"Both WC and WHtR had significantly better discrimination than BMI (respective area under ROC curve: 0.63 for WC, 0.63 for WHtR, and 0.60 for BMI; P = 0.019), and adding WC or WHtR on top of BMI further correctly reclassified 42.7% and 38.7% hypertensive patients to the right risk group of pre-diabetes or diabetes indicated by net reclassification improvement.","['hypertensive patients with pre-diabetes or diabetes', 'Asian hypertensive patients for the first time', '925 subjects aged 40\xa0years or older with uncontrolled hypertension recruited at eight primary care clinics in Singapore', 'adults with hypertension in Singapore polyclinics', '925 subjects, 495 (53.5%) had pre-diabetes or diabetes', 'diabetes or diabetes was defined as having reported physician-diagnosed diabetes or taking anti-diabetes medication, fasting blood glucose\xa0≥\xa05.6\xa0mmol/dL or HbA1c']",['generalized obesity measure (body mass index [BMI'],"['Adiposity measures and pre-diabetes or diabetes', 'height, weight, WC, fasting blood glucose, and hemoglobin A1c']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517904', 'cui_str': '925'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C1532980', 'cui_str': 'mmol/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0342942', 'cui_str': 'Generalized obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",925.0,0.0121795,"Both WC and WHtR had significantly better discrimination than BMI (respective area under ROC curve: 0.63 for WC, 0.63 for WHtR, and 0.60 for BMI; P = 0.019), and adding WC or WHtR on top of BMI further correctly reclassified 42.7% and 38.7% hypertensive patients to the right risk group of pre-diabetes or diabetes indicated by net reclassification improvement.","[{'ForeName': 'Yeli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Rupesh M', 'Initials': 'RM', 'LastName': 'Shirore', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Chandrika', 'Initials': 'C', 'LastName': 'Ramakrishnan', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Ngiap Chuan', 'Initials': 'NC', 'LastName': 'Tan', 'Affiliation': 'Health Services Research Centre, SingHealth, Singapore, Singapore.'}, {'ForeName': 'Tazeen H', 'Initials': 'TH', 'LastName': 'Jafar', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13587']
2943,31262463,High intraocular pressure in eyes with late in-the-bag intraocular lens dislocation.,,2019,,['eyes with late in-the-bag intraocular lens dislocation'],[],['High intraocular pressure'],"[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0948292', 'cui_str': 'Intraocular lens dislocation'}]",[],"[{'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}]",,0.0189876,,"[{'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Kristianslund', 'Affiliation': ''}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': ''}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Drolsum', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.02.042']
2944,33029804,Single or double-layer uterine closure techniques following cesarean: A randomized trial.,"INTRODUCTION


Cesarean deliveries are commonly performed throughout the world. While the uterine closure technique following this procedure may influence how the uterine scar heals, there is insufficient evidence for choosing the appropriate technique and thus preventing long-term negative consequences. This prospective sized study examined the effects of single- and double-layer uterine closure techniques on uterine-scar healing following cesarean delivery.
MATERIAL AND METHODS


This study assessed a total of 282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies. None had previously undergone uterine surgeries. These participants completed their first cesarean deliveries at the time of study and were randomized into the following two treatment groups: single-layer closure with locking and double-layer closure with locking in the first layer, but not in the second layer (NCT03629028). However, the decidua was not included for treatment in either group. Participants were evaluated at 6-9 months after cesarean section by saline infusion sonohysterography to assess cesarean delivery scar defects. These procedures were conducted by experienced sonographers who were not concerned about the uterine closure technique.
RESULTS


Of the 225 final participants, 109 received the single-layer closure technique, while 116 received the double-layer technique. The niche rates were 37% (n=40) for the single-layer group and 45.7% (n=53) for the double-layer group (p=0.22, RR 1.4, 95% CI=0.8-4.4).
CONCLUSIONS


The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.",2020,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"['Of the 225 final participants', 'cesarean', '282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies', 'participants completed their first cesarean deliveries at the time of study']","['single- and double-layer uterine closure techniques', 'Single or double-layer uterine closure techniques', 'single-layer closure with locking and double-layer closure with locking']","['uterine-scar healing', 'niche rates', 'cesarean delivery scar defects']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",282.0,0.192183,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"[{'ForeName': 'Şafak', 'Initials': 'Ş', 'LastName': 'Yilmaz Baran', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kalayci', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Gülşen', 'Initials': 'G', 'LastName': 'Doğan Durdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Yetkinel', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Alemdaroğlu', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Çok', 'Affiliation': 'Division of Reproductive Endocrinology and IVF Unit, Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Esra Bulgan', 'Initials': 'EB', 'LastName': 'Kiliçdağ', 'Affiliation': 'Division of Reproductive Endocrinology and IVF Unit, Department of Obstetrics and Gynecology, Başkent University, Faculty of Medicine, Adana, Turkey.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14018']
2945,33029812,The calcium concentration of peritoneal dialysis solution modifies levels of key mediators of peritoneal fibrosis.,"BACKGROUND


To explore the effects of different calcium concentrations of peritoneal dialysis solution (PDS) on continuous ambulatory peritoneal dialysis (CAPD) and expression of vimentin (VIM), fibroblast-specific protein (FSP1), and E-cadherin.
MATERIALS AND METHODS


This was a pilot study (#ChiCTR1900021387) conducted from January 2017 to December 2019 at the Hospital. The patients were randomized to undergo CAPD using PDS with a calcium concentration of 1.25 mmol/L (low concentration group) or 1.75 mmol/L (high concentration group). Changes in biochemistry before dialysis and at 6 and 12 months were analyzed.
RESULTS


There were 50 and 52 participants in the low and high calcium groups. The blood biochemical indexes were all different between the two groups (all P time   < .05, P group   < .05, P interaction   < .05), but they remained within their normal ranges. VIM and FSP1 increased over 12 months (P time   < .05); VIM and FSP1 levels in the high concentration group were higher than in the low concentration group (P group   < .05, P interaction   < .05), while E-cadherin showed the inverse association (P time   < .001, P group   < .001, P interaction   < .001). There was no difference in complications (P = .973).
CONCLUSION


The calcium concentration in PDS might be an important factor affecting the progression of peritoneal fibrosis.",2020,"VIM and FSP1 increased over 12 months (P time   < .05); VIM and FSP1 levels in the high concentration group were higher than in the low concentration group (P group   < .05, P interaction   ","['peritoneal fibrosis', 'January 2017 to December 2019 at the Hospital', '52 participants in the low and high calcium groups']","['peritoneal dialysis solution (PDS', 'CAPD using PDS with a calcium concentration of 1.25\xa0mmol/L (low concentration group) or 1.75\xa0mmol/L (high concentration group']","['VIM and FSP1 levels', 'continuous ambulatory peritoneal dialysis (CAPD) and expression of vimentin (VIM), fibroblast-specific protein (FSP1), and E-cadherin', 'VIM and FSP1', 'blood biochemical indexes', 'complications']","[{'cui': 'C0521607', 'cui_str': 'Peritoneal fibrosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0553702', 'cui_str': 'Ca++ increased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0353714', 'cui_str': 'Peritoneal dialysis solution'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C2931355', 'cui_str': 'Autosomal dominant spastic paraplegia type 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031140', 'cui_str': 'Continuous ambulatory peritoneal dialysis'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0365332,"VIM and FSP1 increased over 12 months (P time   < .05); VIM and FSP1 levels in the high concentration group were higher than in the low concentration group (P group   < .05, P interaction   ","[{'ForeName': 'Chusheng', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Xiangliang', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Biology and Premed, Gordon College, Wenham, MA, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Zhangjian', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Hanlei', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}, {'ForeName': 'Zengqi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ""Department of Nephrology, Rui'an People's Hospital, Rui'an City, Zhejiang Province, China.""}]",Seminars in dialysis,['10.1111/sdi.12916']
2946,33029828,A Quasi-Experimental Study into the Effects of Naps and Therapy Glasses on Fatigue and Well-being.,"AIMS


To investigate the effects of a napping facility and therapy glasses on fatigue and well-being at the end of the night shift.
BACKGROUND


Night shift work has adverse effects on fatigue and wellbeing.
METHODS


A quasi-experimental study was conducted and data was collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities, or no facilities. Multi-level analyses were conducted to predict fatigue and well-being.
RESULTS


Night shifts of nurses having access to both facilities were associated with less fatigue and more well-being. The use of therapy glasses related negatively to fatigue and positively to well-being. The use of the napping facility was not associated with fatigue and well-being. However, having slept while napping and sleeping time during napping were negatively associated with fatigue and positively associated with well-being.
CONCLUSION


Therapy glasses and sleeping in a napping facility can be effective interventions in reducing the adverse effects of night shift work.
IMPLICATIONS FOR NURSING MANAGEMENT


Therapy glasses seem an effective investment to facilitate the well-being of nurses. To enhance sleeping during napping, it is worthwhile to let nurses get accustomed to the napping facility and customize settings to personal preferences.",2020,The use of the napping facility was not associated with fatigue and well-being.,"['A quasi-experimental study was conducted and data was collected on 243 night shifts of 95 nurses who had either access to a napping facility, therapy glasses, both facilities, or no facilities']",['napping facility and therapy glasses'],[],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",[],,0.0146329,The use of the napping facility was not associated with fatigue and well-being.,"[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'van Woerkom', 'Affiliation': 'Tilburg University, Department of Human Resource Studies, Erasmus University Rotterdam, Department of Psychology, Education and Child Studies.'}]",Journal of nursing management,['10.1111/jonm.13172']
2947,33029843,A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial.,"BACKGROUND


Previously, the diagnosis of irritable bowel syndrome (IBS) required exclusion of organic causes by extensive diagnostic testing. Newer guidelines recommend IBS as a positive diagnosis based on symptoms with limited testing. We investigated the long-term safety and impact on use of health resources of a positive diagnostic strategy compared to a strategy of exclusion in patients with symptoms compatible with IBS.
METHODS


In 2008-2010, primary care patients aged 18-50 years fulfilling the Rome III criteria for IBS without alarm signals were randomized to a positive diagnostic strategy (limited blood tests, n = 150) or a strategy of exclusion (extensive blood tests, fecal samples for intestinal parasites, and sigmoidoscopy with biopsies, n = 152). At five years, hospital-registered diagnoses and use of health resources including lower endoscopies were retrieved from national registries. Participants provided 5-year data on Rome III criteria for IBS, severity of symptoms, and quality of life.
KEY RESULTS


Baseline mean age was 31.4 (SD 9.1) years; 79% were female. No cases of celiac disease, and gastrointestinal or gynecological cancers were diagnosed within five years. Negligible and comparable numbers were diagnosed with inflammatory bowel disease, benign gynecological conditions, and upper GI conditions in the two groups. The positive diagnosis strategy carried a higher number of lower endoscopies from year 1 to 5 (23 patients versus 13 patients in the exclusion group), but overall saved endoscopies.
CONCLUSIONS & INFERENCES


A positive diagnosis of IBS was as safe as a diagnosis of exclusion in a five-year perspective and saved lower endoscopies; the study was registered at ClinicalTrials.gov numbers: NCT00659763/NCT01153295.",2020,"The positive diagnosis strategy carried a higher number of lower endoscopies from year 1 to 5 (23 patients versus 13 patients in the exclusion group), but overall saved endoscopies.
","['patients with irritable bowel syndrome', 'Baseline mean age was 31.4 (SD 9.1) years; 79% were female', 'patients with symptoms compatible with IBS.\nMETHODS', '2008-2010, primary care patients aged 18-50\xa0years fulfilling the Rome III criteria for IBS without alarm signals']","['positive diagnostic strategy (limited blood tests, n\xa0=\xa0150) or a strategy of exclusion (extensive blood tests, fecal samples for intestinal parasites, and sigmoidoscopy with biopsies, n\xa0']","['celiac disease, and gastrointestinal or gynecological cancers', '5-year data on Rome III criteria for IBS, severity of symptoms, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021832', 'cui_str': 'Intestinal parasitism'}, {'cui': 'C0192919', 'cui_str': 'Sigmoidoscopy with biopsy'}]","[{'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.1964,"The positive diagnosis strategy carried a higher number of lower endoscopies from year 1 to 5 (23 patients versus 13 patients in the exclusion group), but overall saved endoscopies.
","[{'ForeName': 'Anne Line', 'Initials': 'AL', 'LastName': 'Engsbro', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge and Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Luise M', 'Initials': 'LM', 'LastName': 'Begtrup', 'Affiliation': 'Department of Occupational and Environmental Medicine, Bispebjerg and Frederiksberg Hospital, København, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Haastrup', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Maria Munch', 'Initials': 'MM', 'LastName': 'Storsveen', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bytzer', 'Affiliation': 'Department of Medicine, Zealand University Hospital, Køge and Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Medical Gastroenterology S, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Schaffalitzky De Muckadell', 'Affiliation': 'Department of Medical Gastroenterology S, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Dorte Ejg', 'Initials': 'DE', 'LastName': 'Jarbøl', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.14004']
2948,33029968,Effects of Multicomponent Exercise on Cognitive Function in Elderly Korean Individuals.,"BACKGROUND AND PURPOSE


The aim of this study was to investigate the effects of multicomponent exercise on cognitive function, depression, and quality of life in elderly individuals.
METHODS


This study prospectively recruited 605 participants, and constructed an exercise pyramid comprising even distributions of daily physical activities, aerobic exercise, muscle-strengthening exercise, flexibility exercise, balance exercise, and activities that subjects could perform while sitting down. The exercise program was divided into six stages according to the participant's level of frailty. The 12-week exercise program intervention was conducted once yearly.
RESULTS


The exercise regimen was followed by 402 of the 605 enrolled participants, giving a dropout rate of 33.6%. The 27-month exercise program was completed by 60 participants. The scores for the Mini Mental State Examination for dementia screening (MMSE-DS), short form of the Geriatric Depression Scale, World Health Organization Quality of Life Assessment (WHOQOL-BREF), International Physical Activity Questionnaire (IPAQ), fear of falling, handgrip strength, and walking speed were improved after the exercise intervention. The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
CONCLUSIONS


Individually customized, multicomponent exercise programs lead to improved levels of cognitive function, depression, and quality of life, especially among those who are more frail.",2020,"The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
","['elderly individuals', '605 participants', 'Elderly Korean Individuals']","['exercise program intervention', 'Multicomponent Exercise', 'exercise pyramid comprising even distributions of daily physical activities, aerobic exercise, muscle-strengthening exercise, flexibility exercise, balance exercise, and activities that subjects could perform while sitting down', 'multicomponent exercise']","['Cognitive Function', 'Mini Mental State Examination for dementia screening (MMSE-DS), short form of the Geriatric Depression Scale, World Health Organization Quality of Life Assessment (WHOQOL-BREF), International Physical Activity Questionnaire (IPAQ), fear of falling, handgrip strength, and walking speed', 'MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed', 'cognitive function, depression, and quality of life', 'levels of cognitive function, depression, and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0560831', 'cui_str': 'Does sit down'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",605.0,0.022109,"The analysis of frailty revealed that participants in the frail group showed greater improvements for the MMSE-DS, WHOQOL-BREF, IPAQ, fear of falling, handgrip strength, and walking speed.
","[{'ForeName': 'Yeon Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Institute of Convergence Bio-Health, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Kiheon', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Sukil', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Public Health, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Chae', 'Affiliation': 'Department of Public Health, College of Medicine, Catholic University, Seoul, Korea.'}, {'ForeName': 'Moon Ho', 'Initials': 'MH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, College of Medicine, Korea. University, Seoul, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hae Ri', 'Initials': 'HR', 'LastName': 'Na', 'Affiliation': 'Department of Neurology, Seongnam Center of Senior Health, Seongnam, Korea.'}]","Journal of clinical neurology (Seoul, Korea)",['10.3988/jcn.2020.16.4.612']
2949,33030020,A Non-inferiority Trial: Safety and Efficacy of Topical 1:1000 versus 1:10 000 Epinephrine in Sino-nasal Surgeries.,"OBJECTIVE


This study aimed to test the non-inferiority of topical 1:1000 epinephrine compared to topical 1:10 000 with regard to intraoperative hemodynamic stability, and to determine whether it produced superior visibility conditions.
METHODS


A single-blinded, prospective, cross-over non-inferiority trial was performed. Topical 1:1000 or topical 1:10 000 was placed in 1 nasal passage. Hemodynamic parameters (heart rate, systolic and diastolic blood pressures, and mean arterial pressure) were measured prior to insertion then every minute for 10 minutes. This was repeated in the contralateral nasal passage of the same patient with the alternate concentration. The surgeon graded the visualization of each passage using the Boezaart Scale. The medians of the greatest absolute change in parameters were compared using a Wilcoxon Rank-Signed test and confidence intervals were calculated using a Hodges-Lehman test. The non-inferiority margin was pre-determined at 10 bpm for heart rate and 10 mmHg for blood pressures. A Wilcoxon Rank-Signed test was used to assess superiority in visualization.
RESULTS


Thirty-two patients were enrolled and after exclusions, nineteen were assessed (mean age = 35.63 ± 12.49). Differences in means of greatest absolute change between the 2 concentrations were calculated (heart rate = 2.49 ± 1.20; systolic = -1.51 ± 2.16; diastolic = 2.47 ± 1.47; mean arterial pressure = 0.07 ± 1.83). In analyses of medians, 1:1000 was non-inferior to the 1:10 000. There was a significant difference (-0.58 ± 0.84;  P  = .012) in visualization in favor of topical 1:1000.
CONCLUSION


Topical 1:1000 epinephrine provides no worse intraoperative hemodynamic stability compared to topical 1:10 000 but affords superior visualization and should be used to optimize surgical conditions.",2020,Topical 1:1000 epinephrine provides no worse intraoperative hemodynamic stability compared to topical 1:10 000 but affords superior visualization and should be used to optimize surgical conditions.,"['Sino-nasal Surgeries', 'Thirty-two patients were enrolled and after exclusions, nineteen were assessed (mean age = 35.63\u2009±\u200912.49']","['Epinephrine', 'Topical 1:1000 epinephrine', 'topical 1:1000 epinephrine']","['intraoperative hemodynamic stability', 'Hemodynamic parameters (heart rate, systolic and diastolic blood pressures, and mean arterial pressure']","[{'cui': 'C0064022', 'cui_str': 'isononanoyl oxybenzene sulfonate'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0456971', 'cui_str': '10 International Units in 0.1mL'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",32.0,0.127639,Topical 1:1000 epinephrine provides no worse intraoperative hemodynamic stability compared to topical 1:10 000 but affords superior visualization and should be used to optimize surgical conditions.,"[{'ForeName': 'Cassie L', 'Initials': 'CL', 'LastName': 'Dow', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Anders W', 'Initials': 'AW', 'LastName': 'Sideris', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Ravjit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Mitchell H', 'Initials': 'MH', 'LastName': 'Giles', 'Affiliation': 'Otolaryngology - Head and Neck Surgery Department, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Meller', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Sim', 'Initials': 'S', 'LastName': 'Choroomi', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Havas', 'Affiliation': 'Otorhinolaryngology Head and Neck Research Group, Prince of Wales Hospital, Randwick, NSW, Australia.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420962825']
2950,33030035,"Comparison of Botulinum Toxin A, Corticosteroid, and Anesthetic Injection for Plantar Fasciitis.","BACKGROUND


Plantar fasciitis is the most common cause of heel pain, and injection therapies are part of the treatment modalities. This study aimed to compare 2 intralesional injection therapies for plantar fasciitis: corticosteroid and botulinum toxin A, compared with a third control group using a local anesthetic. The clinical evolution, as well as changes in the thickness of the plantar fascia and ankle dorsiflexion, was evaluated.
METHODS


A randomized, controlled, double-blind trial design was used. Patients were divided into 3 groups: group 1, anesthetic only; group 2, corticosteroid; and group 3, botulinum toxin A (BoNT-A). We used an ultrasonographic evaluation to measure the plantar fascia thickness. The results were evaluated using the Maryland Foot Score and a 10-cm visual analog scale. Clinical scores were recorded at the beginning of the study, at 2 weeks, and at 1, 3, and 6 months. We evaluated 78 patients for study eligibility. The 3 intervention groups were homogeneous.
RESULTS


All patients showed better clinical outcomes compared with their initial evaluations, without differences between groups at the end of follow-up. The thickness of plantar fascia diminished at the final evaluation, and ankle dorsiflexion was better compared with the initial values without difference between treatment groups.
CONCLUSION


Considering all the evaluated outcomes, no significant differences between treatment groups were observed. The pain relief and functional improvement obtained with the different treatments was maintained during the 6-month follow-up.
LEVEL OF EVIDENCE


Level I, therapeutic study.",2020,"All patients showed better clinical outcomes compared with their initial evaluations, without differences between groups at the end of follow-up.","['plantar fasciitis', '78 patients for study eligibility', 'Plantar Fasciitis']","['Botulinum Toxin A, Corticosteroid, and Anesthetic Injection', 'anesthetic only; group 2, corticosteroid; and group 3, botulinum toxin A (BoNT-A', 'corticosteroid and botulinum toxin']","['Clinical scores', 'pain relief and functional improvement', 'Maryland Foot Score and a 10-cm visual analog scale', 'thickness of plantar fascia', 'plantar fascia thickness', 'ankle dorsiflexion']","[{'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}]",78.0,0.0334347,"All patients showed better clinical outcomes compared with their initial evaluations, without differences between groups at the end of follow-up.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Elizondo-Rodríguez', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Simental-Mendía', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Peña-Martínez', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Vilchez-Cavazos', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Yadira', 'Initials': 'Y', 'LastName': 'Tamez-Mata', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Olivo', 'Affiliation': 'Ortopedia y Traumatología, Facultad de Medicina y Hospital Universitario ""Dr José E. González,"" Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México.'}]",Foot & ankle international,['10.1177/1071100720961093']
2951,33030064,The randomised Oslo study of renal denervation  vs.  Antihypertensive drug adjustments: efficacy and safety through 7 years of follow-up.,"PURPOSE


The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study.
MATERIALS AND METHODS


Patients with treatment-resistant hypertension, defined as daytime systolic ambulatory BP ≥135 mmHg after witnessed intake of ≥3 antihypertensive drugs including a diuretic, were randomised to either RDN ( n  = 9) or drug adjustment ( n  = 10). The initial primary endpoint was the change in office BP after 6 months. The RDN group had their drugs adjusted after 1 year using the same principles as the Drug Adjustment group. Both groups returned for long-term follow-up after 3 and 7 years.
RESULTS


The decrease in office BP and ambulatory BP (ABPM) after 6 months did not persist, but gradually increased in both groups. From 6 months to 7 years follow-up, mean daytime systolic ABPM increased from 142 ± 10 to 145 ± 15 mmHg in the RDN group, and from 133 ± 11 to 137 ± 13 mmHg in the Drug Adjustment group, with the difference between them decreasing. In a mixed factor model, a significantly different variance was found between the groups in daytime systolic ABPM ( p  = .04) and diastolic ABPM ( p  = .01) as well as office diastolic BP ( p <.01), but not in office systolic BP ( p  = .18). At long-term follow-up we unveiled no anatomical- or functional renal impairment in either group.
CONCLUSIONS


BP changes up to 7 years show a tendency towards a smaller difference in BPs between the RDN and drug adjustment patients. Our data support RDN as a safe procedure, but it remains non-superior to intensive drug adjustment 7 years after the intervention.",2020,"At long-term follow-up we unveiled no anatomical- or functional renal impairment in either group.
","['Patients with treatment-resistant hypertension, defined as daytime systolic ambulatory BP ≥135\u2009mmHg after witnessed intake of ≥3 antihypertensive drugs including a diuretic']","['RDN', 'renal sympathetic denervation (RDN']","['change in office BP', 'daytime systolic ABPM', 'mean daytime systolic ABPM', 'BP changes and safety', 'diastolic ABPM', 'blood pressure (BP', 'office diastolic BP', 'office BP and ambulatory BP (ABPM', 'BPs', 'office systolic BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0265125,"At long-term follow-up we unveiled no anatomical- or functional renal impairment in either group.
","[{'ForeName': 'Ola Undrum', 'Initials': 'OU', 'LastName': 'Bergland', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Camilla Lund', 'Initials': 'CL', 'LastName': 'Søraas', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Anne Cecilie K', 'Initials': 'ACK', 'LastName': 'Larstorp', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Lene V', 'Initials': 'LV', 'LastName': 'Halvorsen', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Hjørnholm', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hoffman', 'Affiliation': 'Department of Cardiology, Section for Interventional Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Aud', 'Initials': 'A', 'LastName': 'Høieggen', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Fadl Elmula M', 'Initials': 'FEM', 'LastName': 'Fadl Elmula', 'Affiliation': 'Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.'}]",Blood pressure,['10.1080/08037051.2020.1828818']
2952,33032485,Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial.,"Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64,  P =0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68,  P <0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74,  P =0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.",2020,"More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013).","['One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS', 'patients undergoing saphenous vein grafts intervention regarding long-term outcome', 'Saphenous Vein Grafts']","['drug-eluting stents (DES) versus bare-metal stents (BMS', 'BMS', 'Registration URL', 'Drug-Eluting Versus Bare-Metal Stent Implantation', 'DES', 'paclitaxel-eluting or BMS', 'DES with BMS']","['major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1\xa0year', 'major adverse cardiac events and its individual components at 5-year follow-up', 'adverse cardiac event rates', 'subsequent myocardial infarctions and need for target-vessel revascularization']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",173.0,0.226873,"More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8],  P =0.013).","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Fahrni', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Klinikum Westfalen Dortmund Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospitalet Copenhagen Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Galatius', 'Affiliation': 'Bispebjerg University Hospital Copenhagen Denmark.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Eberli', 'Affiliation': 'Triemli Hospital Zürich Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rickenbacher', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Twerenbold', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Herzzentrum Dresden Technische Universität Dresden Dresden Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schuler', 'Affiliation': 'Heart Center University of Leipzig Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pfisterer', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'Heart Center University of Leipzig Germany.'}, {'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'University Hospital Basel Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.120.017434']
2953,33032532,A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain: randomized controlled trial.,"BACKGROUND


Exercise has shown being effective for managing chronic pain and preventing frailty status in older adults but the effect of an exercise program in the quality of life of pre-frail older adults with chronic pain remains unclear. Our objective was to evaluate the effectiveness of multicomponent structured physical exercise program for pre-frail adults aged 65 years or more with chronic pain to improve their perceived health related quality of life, compared with usual care.
METHODS


Open label randomized controlled trial. Participants were community-dwelling pre-frail older adults aged 65 years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre. Forty-four participants were randomly allocated to a control group (n = 20) that received usual care or an intervention group (n = 24) that received an 8-week physical activity and education program. Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage) were assessed at baseline, after the intervention and after 3 months follow-up. The effect of the intervention was analysed by mean differences between the intervention and control groups.
RESULTS


The follow-up period (3 months) was completed by 32 patients (73%), 17 in the control group and 15 in the intervention group. Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm. No relevant differences were found between groups at baseline. After the intervention, mean differences in the EuroQol Index Value between control and intervention groups were significant (- 0.19 95% CI(- 0.33- -0.04)) and remained after 3 months follow-up (- 0.21 95% CI(- 0.37- -0.05)). Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
CONCLUSIONS


An eight-week physical activity and education program for pre-frail older adults with chronic pain, compared with usual care, could be effective to improve quality of life after the intervention and after three-months follow-up.
STUDY REGISTRATION DETAILS


This study was retrospectively registered in ClinicalTrials.gov with the identifier NCT04045535 .",2020,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","['older adults', 'Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm', 'pre-frail adults aged 65\u2009years or more with chronic pain', 'Participants were community-dwelling pre-frail older adults aged 65\u2009years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre', 'Forty-four participants', 'pre-frail older adults with chronic pain']","['control group (n\u2009=\u200920) that received usual care or an intervention group (n\u2009=\u200924) that received an 8-week physical activity and education program', 'multicomponent structured physical exercise program', 'physical activity program versus usual care', 'exercise program']","['EuroQol Index Value', 'Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage', 'pain intensity and frailty', 'physical performance', 'quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",44.0,0.128245,"Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after 3 months.
","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Otones', 'Affiliation': 'San Andrés Primary Care Center, Gerencia Asistencial de Atención Primaria, Alberto Palacios, 22, 28021, Madrid, Spain. pedro.otones@salud.madrid.org.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'García', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz', 'Affiliation': 'Research Unit, Gerencia Asistencial de Atención Primaria, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Pedraz', 'Affiliation': 'Nursing Department, Universidad Autónoma de Madrid, Madrid, Spain.'}]",BMC geriatrics,['10.1186/s12877-020-01805-3']
2954,33032546,Improving infant sleep safety via electronic health record communication: a randomized controlled trial.,"BACKGROUND


With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines.
METHODS


One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher's Exact test to assess group differences in guideline adherence at 2 months.
RESULTS


One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25-52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface.
CONCLUSIONS


Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices.
TRIAL REGISTRATION


Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None.",2020,"Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75).","['One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention', 'One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery']","['electronic health record communication', 'personalized feedback', 'electronic health record patient portals to transmit photographs']","['feasibility and efficacy', 'Standardized feedback', 'safe sleep criteria']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",,0.220848,"Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75).","[{'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Canty', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Fogel', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Erich K', 'Initials': 'EK', 'LastName': 'Batra', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schaefer', 'Affiliation': 'Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Beiler', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Penn State College of Medicine, HS83, 500 University Drive, Hershey, PA, 17033, USA. ipaul@psu.edu.'}]",BMC pediatrics,['10.1186/s12887-020-02369-2']
2955,33032560,Skin and subcutaneous fascia closure at caesarean section to reduce wound complications: the closure randomised trial.,"BACKGROUND


Wound infection is a common complication following caesarean section. Factors influencing the risk of infection may include the suture material for skin closure, and closure of the subcutaneous fascia. We assessed the effect of skin closure with absorbable versus non-absorbable suture, and closure versus non-closure of the subcutaneous fascia on risk of wound infection following Caesarean section.
METHODS


Women undergoing caesarean birth at an Adelaide maternity hospital were eligible for recruitment to a randomised trial using a 2 × 2 factorial design. Women were randomised to either closure or non-closure of the subcutaneous fascia and to subcuticular skin closure with an absorbable or non-absorbable suture. Participants were randomised to each of the two interventions into one of 4 possible groups: Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia; Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia; Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and Group 4 - absorbable skin suture and closure of the subcutaneous fascia. The primary outcomes were reported wound infection and wound haematoma or seroma within the first 30 days after birth.
RESULTS


A total of 851 women were recruited and randomised, with 849 women included in the analyses (Group 1: 216 women; Group 2: 212 women; Group 3: 212 women; Group 4: 211 women). In women who underwent fascia closure, there was a statistically significant increase in risk of wound infection within 30 days post-operatively for those who had skin closure with an absorbable suture (Group 4), compared with women who had skin closure with a non-absorbable suture (Group 3) (adjusted RR 2.17; 95% CI 1.05, 4.45; p = 0.035). There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
CONCLUSION


The combination of subcutaneous fascia closure and skin closure with an absorbable suture may be associated with an increased risk of reported wound infection after caesarean section.
TRIAL REGISTRATION


Prospectively registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12608000143325 , on the 20th March, 2008.",2020,"There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
","['Women undergoing caesarean birth at an Adelaide maternity hospital were eligible for recruitment to a randomised trial using a 2\u2009×\u20092 factorial design', 'A total of 851 women were recruited and randomised, with 849 women included in the analyses (Group 1: 216 women; Group 2: 212 women; Group 3: 212 women; Group 4: 211 women']","['Skin and subcutaneous fascia closure at caesarean section', 'absorbable suture', 'closure or non-closure of the subcutaneous fascia and to subcuticular skin closure with an absorbable or non-absorbable suture', 'subcutaneous fascia closure and skin closure with an absorbable suture', 'Group 1 - non-absorbable skin suture and non-closure of the subcutaneous fascia; Group 2 - absorbable skin suture and non-closure of the subcutaneous fascia; Group 3 - non-absorbable skin suture and closure of the subcutaneous fascia; and Group 4 - absorbable skin suture and closure of the subcutaneous fascia', 'skin closure with absorbable versus non-absorbable suture, and closure versus non-closure of the subcutaneous fascia']","['wound complications', 'risk of wound infection', 'wound infection and wound haematoma or seroma within the first 30\u2009days after birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0191408', 'cui_str': 'Closure of skin by suture'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0281860', 'cui_str': 'Wound hematoma'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",851.0,0.157617,"There was no significant difference in risk of wound infection for absorbable vs non-absorbable sutures in women who did not undergo fascia closure.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Poprzeczny', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Rosalie M', 'Initials': 'RM', 'LastName': 'Grivell', 'Affiliation': 'Flinders Medical Centre, Department of Obstetrics and Gynaecology, Southern Adelaide Local Health Network, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia. Jodie.dodd@adelaide.edu.au.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03305-z']
2956,33032643,"Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR).","BACKGROUND


To evaluate the clinical outcomes of combination of androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT) boost in high-risk prostate cancer patients.
METHODS


This prospective phase I/IIa study was conducted between 2016 and 2017. Following WPRT of 44 Gy in 20 fractions, patients were randomized to two boost doses, 18 Gy and 21 Gy, in 3 fractions using the Cyberknife system. Primary endpoints were incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS). Secondary endpoints included late toxicities and short-term clinical progression-free survival (CPFS).
RESULTS


A total of 26 patients were enrolled. Twelve patients received a boost dose of 18 Gy, and the rest received 21 Gy. The Median follow-up duration was 35 months. There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities. Sixty-one and 4% of patients experienced grade 1-2 acute GU and GI toxicities, respectively. There were 12% late grade 1-2 GU toxicities and 8% late grade 1-2 GI toxicities. Patient-reported outcomes of urinary symptoms were aggravated after WPRT and SBRT boost. However, they resolved at 1 month and returned to the baseline level at 4 months. Three-year BCRFS was 88.1%, and CPFS was 92.3%.
CONCLUSIONS


The present study protocol demonstrated that the combination of ADT, WPRT, and SBRT boosts for high-risk prostate cancer is safe and feasible, and may reduce total treatment time to 5 weeks. Boost dose of 21 Gy in 3 fractions seems appropriate.
TRIAL REGISTRATION


ClinicalTrials.gov, ID; NCT03322020 - Retrospectively registered on 26 October 2017.",2020,There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities.,"['high-risk prostate cancer patients', 'high-risk prostate cancer (ADEBAR', '26 patients were enrolled', 'IIa study was conducted between 2016 and 2017', 'NCT03322020 - Retrospectively registered on 26 October 2017']","['ADT, WPRT, and SBRT boosts', 'androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost', 'androgen deprivation therapy (ADT), whole pelvic radiotherapy (WPRT), and stereotactic body radiotherapy (SBRT']","['late toxicities and short-term clinical progression-free survival (CPFS', 'grade 1-2 acute GU and GI toxicities', 'incidences of acute toxicities and short-term biochemical recurrence-free survival (BCRFS', 'grade\u2009≥\u20093 genitourinary (GU) or gastrointestinal (GI) toxicities', 'late grade 1-2 GU toxicities and 8% late grade 1-2 GI toxicities', 'urinary symptoms']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",26.0,0.162873,There were no grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicities.,"[{'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.'}, {'ForeName': 'Hanjong', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Choung-Soo', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Seok', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. ysk@amc.seoul.kr.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01665-6']
2957,33032644,Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.,"BACKGROUND


Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care.
METHODS


This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper.
DISCUSSION


The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.",2020,"This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care.
","['at least 17 UK centres', 'pelvic organ prolapse', 'women with prolapse when compared to clinic-based care']","['pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support', 'vaginal pessary self-management', 'clinic-based care']","['quality of life', 'condition-specific quality of life']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.170224,"This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care.
","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK. S.hagen@gcu.ac.uk.'}, {'ForeName': 'Rohna', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': ""The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Kirsteen', 'Initials': 'K', 'LastName': 'Goodman', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Melone', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Sarkis', 'Initials': 'S', 'LastName': 'Manoukian', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'NHS Ayrshire & Arran, Crosshouse Hospital, Kilmarnock, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'NMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park, Stirling, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Dembinsky', 'Affiliation': 'Health Sciences & Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dwyer', 'Affiliation': ""The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Patient and Public Involvement (PPI) representative, Dunlop, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Guerrero', 'Affiliation': 'Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS Trust, Aberdeen, UK.'}, {'ForeName': 'Aethele', 'Initials': 'A', 'LastName': 'Khunda', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Karachalia-Sandri', 'Affiliation': 'Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bugge', 'Affiliation': 'Health Sciences & Sport, University of Stirling, Stirling, UK.'}]",Trials,['10.1186/s13063-020-04738-9']
2958,33032651,The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation.,"BACKGROUND


Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women's condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants' and healthcare professionals' experiences.
METHODS


The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12-18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan.
DISCUSSION


The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.
TRIAL REGISTRATION


ISRCTN62510577 . Registered on 6 October 2017.",2020,The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented.,"['n\xa0=\u200920) and healthcare professionals recruiting to the trial (n\xa0~\u200917) and delivering self-management and clinic-based care (n\xa0~\u200917', '330 women from approximately 17 UK centres', 'women with pelvic organ prolapse', ""participants' and healthcare professionals' experiences"", 'randomised women (18 per randomised group/n\xa0=\u200936), women who declined trial participation but agreed to interview (non-randomised women', 'pelvic organ prolapse']","['pessary self-management with clinic-based care', 'self-management 2-week follow-up telephone calls']",[],"[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[],330.0,0.162961,The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented.,"[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bugge', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK. carol.bugge@stir.ac.uk.'}, {'ForeName': 'Rohna', 'Initials': 'R', 'LastName': 'Kearney', 'Affiliation': ""The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Dembinsky', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Aethele', 'Initials': 'A', 'LastName': 'Khunda', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'NHS Ayrshire & Arran, Crosshouse Hospital, School of Medicine, Dentistry & Nursing, University of Glasgow, Kilmarnock, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dwyer', 'Affiliation': ""The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsteen', 'Initials': 'K', 'LastName': 'Goodman', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Guerrero', 'Affiliation': 'Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Grampian University Hospitals NHS Trust, Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mason', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'McClurg', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Melone', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}]",Trials,['10.1186/s13063-020-04729-w']
2959,33032655,"Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial.","BACKGROUND


Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS.
DESIGN AND METHODS


The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI.
DISCUSSION


The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017524 . Registered on 5 July 2019.",2020,Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI.,"['patients with symptomatic stable CAD/CCS', 'chronic coronary syndrome', 'patients with stable CAD/CCS on top of PCI', 'One hundred forty four patients with a frequency of AP\u2009≥\u20092/week']","['visualization of successful revascularization', 'visual demonstration of successful PCI', 'visual angiographic result demonstration']","['changes in other SAQ-derived scores and dyspnea (NYHA score', 'Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6\u2009months after PCI', 'chest pain and quality of life', 'disease symptoms and QoL', 'quality of life (QoL) and angina pectoris (AP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",144.0,0.105444,Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wester', 'Affiliation': 'University Heart Centre Regensburg, Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Koll', 'Affiliation': 'University Heart Centre Regensburg, Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Centre for Clinical Studies, University Medical Centre, Regensburg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dempfle', 'Affiliation': 'Institute of Medical Informatics and Statistics, University Medical Centre Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Centre for Clinical Studies, University Medical Centre, Regensburg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'Department of Internal Medicine III, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'University Heart Centre Regensburg, Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Sossalla', 'Affiliation': 'University Heart Centre Regensburg, Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany. samuel.sossalla@ukr.de.'}]",Trials,['10.1186/s13063-020-04710-7']
2960,33030228,Periodontal surgery using rhFGF-2 with deproteinized bovine bone mineral or rhFGF-2 alone: 2-year follow-up of a randomized controlled trial.,"AIM


To compare outcomes of rhFGF-2 + DBBM therapy with rhFGF-2 alone in the treatment of intrabony defects. This study provides 2-year follow-up results from the previous randomized controlled trial.
MATERIALS AND METHODS


Defects were randomly allocated to receive rhFGF-2 + DBBM (test group) or rhFGF-2 (control group). Treated sites were reevaluated at 2 years postoperatively, using original clinical and patient-centered measures.
RESULTS


Thirty-eight sites were available for reevaluation. At 2 years, both groups showed a significant improvement in clinical attachment level (CAL) from baseline. A gain in CAL of 3.4 ± 1.3 mm in the test and 3.1 ± 1.5 mm in the control groups was found. No significant intergroup difference was noted. Both groups showed a progressive increase in radiographic bone fill (RBF). The test group yielded greater RBF (56%) compared with the control group (41%). The control therapy performed better in contained defects in terms of CAL and RBF. There was no significant difference in patient-reported outcomes between groups.
CONCLUSIONS


At 2-year follow-up, both treatments were equally effective in improving CAL, while the combination therapy achieved a significantly greater RBF. In both treatments, favorable clinical, radiographic, and patient-reported outcomes can be sustained for at least 2 years.",2020,The test group yielded greater RBF (56%) compared with the control group (41%).,"['Defects', 'intrabony defects']","['rhFGF-2 + DBBM therapy with rhFGF-2 alone', 'rhFGF-2 + DBBM (test group) or rhFGF-2 (control group', 'rhFGF-2 with deproteinized bovine bone mineral or rhFGF-2 alone']","['radiographic bone fill (RBF', 'clinical attachment level (CAL', 'RBF']","[{'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0641117,The test group yielded greater RBF (56%) compared with the control group (41%).,"[{'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Aoki', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Bizenjima', 'Affiliation': 'Tokyo Dental College Chiba Dental Center, Chiba, Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Seshima', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Irokawa', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Kouki', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Yoshida', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Imamura', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Matsugami', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Yurie', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Kita', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sugito', 'Affiliation': 'Department of Dental Hygiene, Tokyo Dental Junior College, Tokyo, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Tomita', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Department of Periodontology, Tokyo Dental College, Tokyo, Japan.'}]",Journal of clinical periodontology,['10.1111/jcpe.13385']
2961,33030269,The central blood volume as measured by thoracic electrical impedance and plasma proANP is not compromised by donation of 900 mL of blood in men.,"OBJECTIVES


To evaluate whether the donation of 900 mL of blood reduces the central blood volume (CBV) assessed by thoracic electrical impedance (TI) and plasma pro-atrial natriuretic peptide (proANP).
BACKGROUND


Donation of 450 mL of blood carries a 1% risk of a vasovagal reaction. Withdrawal of 900 mL of blood decreases cardiac output; however, the effect on CBV remains unknown.
METHODS/MATERIALS


A randomised, single-blinded, placebo-controlled, crossover design was used, where 21 healthy semi-recumbent men donated 2 × 450 mL blood or were sham-phlebotomised. Changes in CBV were estimated by proANP and TI at 1.5 (TI 1.5  ) and 100 (TI 100  ) kHz, reflecting extracellular volume and (regional) total body water, respectively, and the index value (IDX; 1/T 1.5  -1/TI 100  ) was used to estimate changes in intracellular (red cell) volume. Systolic, diastolic and mean arterial blood pressure; heart rate; stroke volume; cardiac output; and systemic vascular resistance were monitored. After completion of the study, 1000 mL of isotonic saline was infused.
RESULTS


Changes (mean% ± SD) in TI 1.5  , TI 100  and IDX were similar after 450 mL (-0.2 ± 1.6%, 0.0 ± 1.1%, -0.4 ± 10.1%) and 900 mL (0.1 ± 1.6%, 0.2 ± 1.5% and -2.0 ± 15.8%) of blood donation compared to after a sham donation of 450 mL (-0.9 ± 1.2%, -0.5 ± 1.5% and -0.1 ± 6.1%) and 900 mL (-1.2 ± 1.5%, -0.6 ± 1.3% and 0.5 ± 9.9%). In addition, changes in plasma proANP were similar after 450 and 900 mL of blood donation (-0.8 ± 6.7% and -7.6 ± 7.9%) as after sham donations (1.3 ± 7.3% and -4.5 ± 5.6%). Monitoring haemodynamic variables revealed that stroke volume decreased after the donation of 900 mL of blood (-12 ± 12 mL) compared to sham donations.
CONCLUSION


During a 900-mL blood loss in semi-recumbent men, CBV measured by TI and plasma proANP is not affected.",2020,"RESULTS


Changes (mean% ± SD) in TI 1.5  , TI 100  and IDX were similar after 450 mL (-0.2 ± 1.6%, 0.0 ± 1.1%, -0.4 ± 10.1%) and 900 mL (0.1 ± 1.6%, 0.2 ± 1.5% and -2.0 ± 15.8%) of blood donation compared to after a sham donation of 450 mL (-0.9 ± 1.2%, -0.5 ± 1.5% and -0.1 ± 6.1%) and 900 mL (-1.2 ± 1.5%, -0.6 ± 1.3% and 0.5 ± 9.9%).",['21 healthy semi-recumbent men donated 2\u2009×\u2009450\u2009mL blood or were sham-phlebotomised'],"['placebo', 'isotonic saline']","['blood donation', 'Changes in CBV', 'Systolic, diastolic and mean arterial blood pressure; heart rate; stroke volume; cardiac output; and systemic vascular resistance', 'stroke volume', 'central blood volume (CBV) assessed by thoracic electrical impedance (TI) and plasma pro-atrial natriuretic peptide (proANP', 'plasma proANP']","[{'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}]",,0.147116,"RESULTS


Changes (mean% ± SD) in TI 1.5  , TI 100  and IDX were similar after 450 mL (-0.2 ± 1.6%, 0.0 ± 1.1%, -0.4 ± 10.1%) and 900 mL (0.1 ± 1.6%, 0.2 ± 1.5% and -2.0 ± 15.8%) of blood donation compared to after a sham donation of 450 mL (-0.9 ± 1.2%, -0.5 ± 1.5% and -0.1 ± 6.1%) and 900 mL (-1.2 ± 1.5%, -0.6 ± 1.3% and 0.5 ± 9.9%).","[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Gybel-Brask', 'Affiliation': 'Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pär I', 'Initials': 'PI', 'LastName': 'Johansson', 'Affiliation': 'Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anesthesiology & The Copenhagen Muscle Research Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}]","Transfusion medicine (Oxford, England)",['10.1111/tme.12727']
2962,33030273,Long-term magnesium supplementation improves glucocorticoid metabolism: A post-hoc analysis of an intervention trial.,"OBJECTIVE


Increasing magnesium intake might reduce the risk of cardiovascular disease (CVD). Whether potential effects on cortisol contribute to these beneficial effects on cardiovascular health remains unclear. We therefore studied effects of long-term oral magnesium supplementation on glucocorticoid metabolism, specifically on the excretion of urinary cortisol, cortisone, and their metabolites, as well as on the ratios reflecting enzymatic activity of 11β-hydroxysteroid dehydrogenases (11β-HSDs) and A-ring reductases.
DESIGN


A post-hoc analysis of a randomized trial with allocation to a magnesium supplement (350 mg/d) or a placebo for 24-wk.
PATIENTS


Forty-nine overweight men and women, aged between 45-70 years.
MEASUREMENTS


Cortisol, cortisone, and their metabolites (tetrahydrocortisol [THF], allo-tetrahydrocortisol [allo-THF], and tetrahydrocortisone [THE]) were measured in 24-h urine samples. Enzymatic activities of 11β-HSD overall and of 11β-HSD type 2 were estimated as the urinary (THF + allo-THF [THFs])/THE and cortisol/cortisone ratios, respectively. A-ring reductase activity was assessed by ratios of THF/allo-THF, allo-THF/cortisol, THF/cortisol, and THE/cortisone.
RESULTS


After 24-wk, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, P=0.021). Ratios of THFs/THE and cortisol/cortisone were decreased following magnesium supplementation by 0.09 (95% CI: 0.02; 0.17, P=0.018) and 0.10 (95% CI: 0.03; 0.17P=0.005), respectively. No effects were observed on A-ring reductase activity.
CONCLUSIONS


We observed a beneficial effect of magnesium supplementation towards a lower 24-h urinary cortisol excretion together with an increased activity of 11β-HSD type 2. Our findings may provide another potential mechanism by which increased magnesium intake lowers CVD risk (ClinicalTrials.gov identifier: NCT02235805).",2020,"After 24-wk, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, P=0.021).","['Forty-nine overweight men and women, aged between 45-70 years']","['placebo', 'magnesium supplement', 'magnesium supplementation']","['Cortisol, cortisone, and their metabolites (tetrahydrocortisol [THF], allo-tetrahydrocortisol [allo-THF], and tetrahydrocortisone [THE', 'excretion of urinary cortisol, cortisone, and their metabolites', 'Ratios of THFs/THE and cortisol/cortisone', 'glucocorticoid metabolism', '24-h urinary cortisol excretion', 'Enzymatic activities of 11β-HSD overall and of 11β-HSD type 2', 'urinary (THF + allo-THF [THFs])/THE and cortisol/cortisone ratios', 'urinary cortisol excretion']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268858', 'cui_str': 'Magnesium supplement agent'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0039664', 'cui_str': 'Tetrahydrocortisol'}, {'cui': 'C0051222', 'cui_str': '3-alpha-allo-tetrahydrocortisol'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1837657', 'cui_str': 'CHST3-related skeletal dysplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",49.0,0.264381,"After 24-wk, urinary cortisol excretion was decreased in the magnesium group as compared with the placebo group (-32 nmol/24-h, 95% CI: -59; -5 nmol/24-h, P=0.021).","[{'ForeName': 'Joëlle C', 'Initials': 'JC', 'LastName': 'Schutten', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Isidor', 'Initials': 'I', 'LastName': 'Minović', 'Affiliation': 'Department of Laboratory Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Post', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'van Beek', 'Affiliation': 'Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Clinical endocrinology,['10.1111/cen.14350']
2963,33030304,Circulating lipids in men with type 2 diabetes following 3 days on a carbohydrate-free diet versus 3 days of fasting.,"OBJECTIVE


We have been interested in determining the effects of dietary changes on fuel metabolism and regulation in men with type 2 diabetes mellitus (T2DM). In this study, the changes in 24-hr circulating lipid profiles were determined when the major fuel source was endogenous versus exogenous fat.
METHODS


Seven males with T2DM were randomized in a crossover design with a 4-week washout period. A standard mixed (control) diet (30%fat:15%protein:55%carbohydrate) was provided initially. Subsequently, a 72-hr (3-day) fast, or a high fat (85%), 15% protein, essentially carbohydrate-free (CHO-free) diet was provided for 72 hr. Triacylglycerol (TAG), non-esterified fatty acids (NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1 (IGFBP-1) profiles were determined during the last 24 hr of intervention, as well as during the control diet.
RESULTS


Regardless of the amount of dietary fat (30% vs 85%) and differences in 24-hr profiles, TAG, NEFA, and bHB all returned to the previous basal concentrations within 24 hr. TAGs and NEFAs changed only modestly with fasting; bHB was elevated and increasing. The IGFBP-1 profile was essentially unchanged with either diet but increased with fasting.
CONCLUSION


A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning. A negative NEFA profile occurred with the control diet. Thus, mechanisms are present to restore lipid concentrations to their original AM concentrations daily. Fasting resulted in stable concentrations, except for a continuing increase in bHB. Glucose and insulin, common fuel regulators, could not explain the results.",2020,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","['men with type 2 diabetes', 'Seven males with T2DM', 'men with type 2 diabetes mellitus (T2DM']","['standard mixed (control) diet (30%fat:15%protein:55%carbohydrate', 'carbohydrate-free diet']","['Triacylglycerol (TAG), non-esterified fatty acids', 'Circulating lipids', '24-hr circulating lipid profiles', '24-hr profiles, TAG, NEFA, and bHB', 'IGFBP-1 profile', 'NEFA), β-hydroxybutyrate (bHB), and insulin-like growth factor-binding protein-1', 'bHB']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452308', 'cui_str': 'Carbohydrate-free diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",7.0,0.013052,"A CHO-free diet resulted in a large increase in TAG and NEFA versus the control diet; however, both were cleared by the following morning.","[{'ForeName': 'Frank Q', 'Initials': 'FQ', 'LastName': 'Nuttall', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Rami M', 'Initials': 'RM', 'LastName': 'Almokayyad', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Gannon', 'Affiliation': 'Section of Endocrinology, Metabolism & Nutrition, and the Metabolic Research Laboratory, Minneapolis VA Health Care System, University of Minnesota, Minneapolis, MN, USA.'}]",Physiological reports,['10.14814/phy2.14569']
2964,33030312,Responding to the ECHO trial results: modelling the potential impact of changing contraceptive method mix on HIV and reproductive health in South Africa.,"INTRODUCTION


Some observational data suggest that the progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA) may increase a woman's risk of HIV acquisition but a randomized clinical trial did not find a statistically significant increase in HIV risk for women using DMPA compared to two other methods. However, it could not rule out up to 30% increased HIV risk for DMPA users. We evaluate changes to contraceptive method mix in South Africa under different assumptions about the existence and strength of a possible undetected relationship between DMPA use and HIV risk.
METHODS


A mathematical model was developed to simulate the ongoing HIV epidemic and contraceptive method mix in South Africa to estimate how changes in method mix could impact HIV- and reproductive health-related outcomes. We made different assumptions about the relationship between DMPA use and HIV risk, from no relationship to a 30% increase in HIV risk for women using DMPA. Scenario analyses were used to investigate the impact of switching away from DMPA predominance to new patterns of contraceptive use.
RESULTS


In South Africa, the HIV-related benefits of reduced DMPA use could be as great as the harms of increased adverse reproductive health outcomes over 20 years, if DMPA did increase the risk of HIV acquisition by a relative hazard of infection of 1.1 or greater. A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes. The most important driver of adverse reproductive health outcomes is the proportion of women who switch away from DMPA to no contraceptive method.
CONCLUSIONS


If there is any real increased HIV risk for DMPA users that has not been detected by the recent randomized trial, a reduction in DMPA use could reduce the ongoing number of new HIV infections. However, such a change would place more women at risk of adverse reproductive health effects. It is imperative that these effects are minimized by focusing on expanding access to safe, effective and acceptable alternative contraceptive methods for all women.",2020,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","['women who switch away from DMPA to no contraceptive method', 'HIV and reproductive health in South Africa']",['progestogen injectable contraceptive depot medroxyprogesterone acetate (DMPA'],"['HIV risk', 'risk of HIV acquisition']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.260324,"A reduction in DMPA use among HIV-positive women would have no benefit in terms of HIV infections, but would incur additional negative reproductive health outcomes.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Beacroft', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fareed', 'Initials': 'F', 'LastName': 'Abdullah', 'Affiliation': 'Office of AIDS and TB Research, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Buyile', 'Initials': 'B', 'LastName': 'Buthelezi', 'Affiliation': 'USAID, Pretoria, South Africa.'}, {'ForeName': 'Manala', 'Initials': 'M', 'LastName': 'Makua', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Morroni', 'Affiliation': 'Botswana Harvard AIDS Institute, Gaborone, Botswana.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Ramjee', 'Affiliation': 'Aurum Institute, Parktown, South Africa.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Velasquez', 'Affiliation': 'UNAIDS Eastern and Southern Africa, Johannesburg, South Africa.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London, London, United Kingdom.'}]",Journal of the International AIDS Society,['10.1002/jia2.25620']
2965,33030349,Comparison of the Effect of Kinesio Taping and Manual Lymphatic Drainage on Breast Engorgement in Postpartum Women: A Randomized-Controlled Trial.,"Objectives:  To investigate the effect of kinesio taping (KT) and manual lymphatic drainage (MLD) on pain severity, breast engorgement, and milk volume in postpartum women.  Materials and Methods:  In this prospective randomized-controlled trial, we recruited 67 postpartum women who had breast engorgement and randomly assigned them to the KT, MLD, and control group. In the KT group, taping plus breast care was performed, MLD plus breast care was performed in the MLD group, and in the control group, only routine breast care was given for 10 days. Pain, breast engorgement, body temperature, and milk volume were measured. Examinations were repeated on days 1, 4, and 10.  Results:  The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05). Milk volume increased among three groups, but the change in the MLD group was higher than in the KT and control groups ( p  < 0.05). There was no significant difference in the milk volume among the KT and control groups at all postintervention days ( p  > 0.05).  Conclusions:  MLD relieved breast pain and firmness more and increased milk volume in postpartum women compared with the KT and control groups. MLD can be recommended to postnatal mothers to better manage breast engorgement.",2020,The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05).,"['Postpartum Women', '67 postpartum women who had breast engorgement and randomly assigned them to the KT, MLD, and control group', 'postpartum women']","['kinesio taping (KT) and manual lymphatic drainage (MLD', 'MLD', 'Kinesio Taping and Manual Lymphatic Drainage']","['milk volume', 'pain and breast engorgement', 'pain severity, breast engorgement, and milk volume', 'Pain, breast engorgement, body temperature, and milk volume', 'Milk volume']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0085688', 'cui_str': 'Engorgement of breasts'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic leukodystrophy'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085688', 'cui_str': 'Engorgement of breasts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",67.0,0.0503833,The MLD group had significant reductions in pain and breast engorgement at all postintervention days compared with the control and KT group ( p  < 0.05).,"[{'ForeName': 'Hanife', 'Initials': 'H', 'LastName': 'Doğan', 'Affiliation': 'Sarıkaya School of Physiotherapy and Rehabilitation, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Gynecology and Obstetrics, Educational and Research Hospital, Başkent University, Konya, Turkey.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Akbayrak', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0115']
2966,33030598,Physical exercise during adjuvant chemotherapy for colorectal cancer-a non-randomized feasibility study.,"BACKGROUND


Colorectal cancer (CRC) is the third most common cancer worldwide, and a large proportion of the patients receive adjuvant oxaliplatin-based chemotherapy. Most of these experience chemotherapy-induced peripheral neuropathy (CIPN), affecting quality of life. Evidence to advise exercise to reduce CIPN is limited. The primary aim of this study was to investigate the feasibility of an exercise intervention and data collection among CRC patients during adjuvant chemotherapy.
MATERIAL AND METHODS


This non-randomized feasibility study included CRC patients admitted to adjuvant chemotherapy to an intervention consisting of supervised aerobic endurance, resistance, and balance exercises twice a week at the hospital in addition to home-based exercise once a week. A physiotherapist supervised the patients, and the intervention lasted throughout the period of adjuvant chemotherapy (12-24 weeks). Participants performed physical tests and filled in questionnaires at baseline, 3, 6, 9, and 12 months.
RESULTS AND CONCLUSION


Nineteen (63%) of 30 invited patients consented. A major barrier to recruit or consent to participation was long travel distance to the hospital. The completion rate of questionnaires and physical tests were near 100%. Seven participants dropped out, five before the intervention started. Median attendance to supervised exercise was 85%. There were no serious adverse events related to the intervention. Except for a planned higher intensity of endurance exercise, we found the intervention feasible and safe. Based on experiences in this study, some adjustments have been made for an upcoming randomized trial, including the supervised exercise taking place close to participants' homes.
TRIAL REGISTRATION


NCT03885817, March 22, 2019, retrospectively registered.",2020,There were no serious adverse events related to the intervention.,"[""participants' homes"", 'Colorectal cancer (CRC', 'CRC patients admitted to adjuvant chemotherapy to an intervention consisting of', 'CRC patients during adjuvant chemotherapy', 'Nineteen (63%) of 30 invited patients consented']","['adjuvant oxaliplatin-based chemotherapy', 'supervised aerobic endurance, resistance, and balance exercises', 'Physical exercise during adjuvant chemotherapy', 'exercise intervention']","['peripheral neuropathy (CIPN), affecting quality of life', 'completion rate of questionnaires and physical tests', 'Median attendance to supervised exercise', 'intervention feasible and safe', 'serious adverse events']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.0696236,There were no serious adverse events related to the intervention.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hatlevoll', 'Affiliation': ""Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway. ingunn.hatlevoll@stolav.no.""}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Oldervoll', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wibe', 'Affiliation': 'Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Stene', 'Affiliation': ""Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hofsli', 'Affiliation': ""Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05789-z']
2967,33030703,Pharmacodynamic and Pharmacokinetic Interaction Profile of Vericiguat: Results from Three Randomized Phase I Studies in Healthy Volunteers.,"BACKGROUND


Vericiguat, a direct stimulator of soluble guanylate cyclase, has been developed as a first-in-class therapy for symptomatic chronic heart failure (HF) and ejection fraction < 45%.
METHODS


Safety, pharmacodynamic (PD), and pharmacokinetic (PK) interactions between vericiguat and drugs used in HF (sacubitril/valsartan [SV] and aspirin [acetylsalicylic acid]) or with a narrow therapeutic index (warfarin) were evaluated in three phase I studies.
RESULTS


Vericiguat 15 mg (single dose [SD]) had no effect on bleeding time or platelet aggregation when coadministered with aspirin 1000 mg versus aspirin alone: estimated differences in least squares means 2.7% (95% confidence interval [CI] - 90.4 to 95.8) and 2.4% (95% CI - 7.0 to 11.8) turbidimetry, respectively. Vericiguat 10 mg (once daily) had no effect on coagulation inhibition elicited by warfarin 25 mg (SD; mean ratios of area under the concentration-time curve from time zero to 96 h for clotting parameter treatment comparisons approximated 100.0%). There were no clinically relevant PD changes whether SV 97/103 mg was administered with single or multiple doses of vericiguat 2.5 mg or placebo (differences in systolic blood pressure [BP] - 1.66 mmHg [90% CI - 4.22 to 0.90]; diastolic BP - 1.80 mmHg [90% CI - 3.24 to - 0.36]; heart rate - 0.33 beats/min [90% CI - 2.25 to 1.60]). Vericiguat demonstrated no PK interactions when coadministered with aspirin, warfarin, or SV at steady state. Treatments were well tolerated.
CONCLUSIONS


Coadministration of vericiguat with SV, aspirin, or warfarin was well tolerated. No clinically relevant PD or PK interactions were observed, supporting concomitant use of these drugs, commonly used by patients with HF, with vericiguat and no dose adjustment.
EUDRACT NUMBER


2014-000765-52; 2014-004880-19; 2015-004809-16.",2020,There were no clinically relevant PD changes whether SV 97/103 mg was administered with single or multiple doses of vericiguat 2.5 mg or placebo (differences in systolic blood pressure [BP] - 1.66 mmHg,"['Healthy Volunteers', 'Vericiguat 15', 'Vericiguat']","['HF (sacubitril/valsartan [SV] and aspirin [acetylsalicylic acid', 'SV, aspirin, or warfarin', 'vericiguat 2.5\xa0mg or placebo', 'warfarin', 'narrow therapeutic index (warfarin', 'aspirin', 'aspirin, warfarin']","['systolic blood pressure [BP', 'coagulation inhibition elicited', 'pharmacodynamic (PD), and pharmacokinetic (PK) interactions', 'tolerated', 'diastolic BP', 'bleeding time or platelet aggregation', 'relevant PD or PK interactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}]",,0.125894,There were no clinically relevant PD changes whether SV 97/103 mg was administered with single or multiple doses of vericiguat 2.5 mg or placebo (differences in systolic blood pressure [BP] - 1.66 mmHg,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boettcher', 'Affiliation': 'Clinical Pharmacology, Bayer AG, Research and Development, Pharmaceuticals, Aprather Weg 18a, 42113, Wuppertal, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Loewen', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Gerrits', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Clinical Pharmacology, Bayer AG, Research and Development, Pharmaceuticals, Aprather Weg 18a, 42113, Wuppertal, Germany. corina.becker@bayer.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00935-6']
2968,33030721,Results of a Preceptor Improvement Project.,"BACKGROUND AND OBJECTIVES


The majority of medical students receive some of their training with a community preceptor. Nearly all of these preceptors are motivated by a desire to give back to their profession through teaching and they want to learn how to teach more effectively. Designing effective educational programs to improve preceptor teaching is important to upholding the quality of medical education.
METHODS


We designed an educational program consisting of readings, short videos, handouts and posters, as well as one-on-one sessions with a trained standardized medical student. The standardized student visited the community physician's office both before and after the preceptor engaged with the educational materials related to a subject area of the preceptor's choosing. We assessed the preceptor's teaching using three tools: self-evaluation, student reporting of observed behaviors, and an overall rating of teaching effectiveness.
RESULTS


Thirteen preceptors took part in this the educational intervention. Per the self-assessment, preceptors showed improved teaching competency for all items on the questionnaire, with 12 of the 21 items (57%) showing statistically significant results (P&lt;.05). The standardized student reported that preceptors used more of eight desired teaching behaviors in the second mock preceptor encounter than they used in the first, with a mean increase of 1.46 (P=.001). Overall teaching effectiveness scores increased, with a mean increase of 1.15 (P=.001) on the 10-point scale. Moreover, all participants indicated they were either satisfied or highly satisfied with the program and that they would recommend this program to a colleague.
CONCLUSIONS


Our preceptor-improvement intervention led to demonstrable improvement in preceptor teaching, as measured by preceptor evaluation and evaluation by the standardized student. More research is needed to see if these results can be replicated and, in particular, to determine which aspects of the intervention were most useful.",2020,"Overall teaching effectiveness scores increased, with a mean increase of 1.15 (P=.001) on the 10-point scale.",[],[],"['teaching competency', 'Overall teaching effectiveness scores']",[],[],"[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0154452,"Overall teaching effectiveness scores increased, with a mean increase of 1.15 (P=.001) on the 10-point scale.","[{'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Brink', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'University of Minnesota, Department of Family Medicine and Community Health, Minneapolis, MN.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leppink', 'Affiliation': 'University of Minnesota, Department of Family Medicine and Community Health, Minneapolis, MN.'}]",Family medicine,['10.22454/FamMed.2020.675133']
2969,33030730,"Subcutaneous rifampicin versus povidone-iodine for the prevention of incisional surgical site infections following gynecologic oncology surgery - a prospective, randomized, controlled trial.","OBJECTIVES


Surgical site infection (SSI) following gynecologic oncology surgery is a severe problem for both patient and surgeon in terms of increasing morbidity, length of hospital stay, anxiety, and costs. In this prospective, randomized, controlled study we investigated the effect of subcutaneous rifampicin and povidone-iodine on incisional SSI following gynecologic oncology surgery.
MATERIAL AND METHODS


Three hundred patients scheduled for abdominal surgery due to any malign gynecological pathology were randomly assigned into one of three groups of 100 members each, as follows: the subcutaneous tissue was irrigated with saline in Group 1; saline + 10% povidone iodine in Group 2; saline + rifampicin in Group 3. Patients were invited to follow-up once every 10 days in a 30-day period for evaluation. Patients who developed a superficial incisional SSI were recorded.
RESULTS


No significant relationship was observed between the SSI and the subcutaneous agents used (p = 0.332). It was observed that there was a statistically significant increase in the rate of incisional surgical site infections as the period of hospitalization (p = 0.044), patient's age (p = 0.003), existence of comorbidities (p = 0.001), and perioperative blood transfusion (p = 0.021) increased.
CONCLUSIONS


Subcutaneous agents are not effective in preventing surgical site infections after gynecologic oncology surgeries. Further large-scale prospective randomized controlled studies may provide other options to prevent SSIs.",2020,No significant relationship was observed between the SSI and the subcutaneous agents used (p = 0.332).,"['incisional surgical site infections following gynecologic oncology surgery ', 'Three hundred patients scheduled for abdominal surgery due to any malign gynecological pathology']","['subcutaneous rifampicin and povidone-iodine', 'subcutaneous tissue was irrigated with saline in Group 1; saline + 10% povidone iodine in Group 2; saline + rifampicin', 'Subcutaneous rifampicin', 'povidone-iodine']","['incisional SSI', 'rate of incisional surgical site infections', 'perioperative blood transfusion', 'superficial incisional SSI', 'surgical site infections']","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C3662309', 'cui_str': 'Superficial incisional surgical site infection'}]",300.0,0.100551,No significant relationship was observed between the SSI and the subcutaneous agents used (p = 0.332).,"[{'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Kömürcü Karuserci', 'Affiliation': 'Gaziantep University, Turkey. ozgekomurcu@hotmail.com.'}, {'ForeName': 'Özcan', 'Initials': 'Ö', 'LastName': 'Balat', 'Affiliation': 'Gaziantep University, Turkey.'}]",Ginekologia polska,['10.5603/GP.a2020.0134']
2970,33030755,12-week secukinumab treatment is consistently efficacious for moderate-to-severe psoriasis regardless of prior biologic and non-biologic systemic treatment: Post-hoc analysis of six randomized trials.,"BACKGROUND


The efficacy of biologic therapies is greater amongst biologic-naive versus biologic-experienced psoriasis patients. However, little is known as to whether prior use of other systemic therapies impacts secukinumab efficacy in patients with moderate-to-severe psoriasis.
OBJECTIVE


To investigate the impact of prior exposure to systemic therapies upon the efficacy and safety of secukinumab 300 mg for moderate-to-severe psoriasis.
METHODS


Post-hoc analysis of six randomized controlled trials (RCTs) comparing secukinumab with placebo, ustekinumab or etanercept at 12 weeks of treatment. Data comparing secukinumab with placebo and ustekinumab were meta-analysed, whilst comparisons between secukinumab and etanercept were from a single RCT. Four subgroups of patients were assessed: 1) naïve to non-biologic systemics (NBS) and biologics; 2) exposed to NBS but naïve to biologics; 3) naïve to NBS but exposed to biologics; and 4) exposed to NBS and biologics. Outcomes of interest included: Investigator's Global Assessment (IGA) score, absolute Psoriasis Area and Severity Index (PASI) response, PASI 75, 90 and 100 response and Dermatology Life Quality Index (DLQI). Safety was also assessed.
RESULTS


1,383 patients were included in the secukinumab versus placebo meta-analysis: 1,776 in the secukinumab versus ustekinumab meta-analysis, and 653 in the within-trial analyses of secukinumab versus etanercept. For all subgroups, secukinumab was significantly more efficacious than placebo for all outcomes measured. Secukinumab generated greater responses in biologic-naïve patients, while prior NBS had a negligible impact on treatment response. Furthermore, secukinumab was more efficacious than both ustekinumab and etanercept on many outcomes; with an even greater difference for biologic-naïve than biologic-exposed patients. Safety results were consistent with individual clinical trial results.
CONCLUSIONS


12-week treatment with secukinumab 300 mg is consistently more efficacious than placebo, etanercept and ustekinumab in patients with moderate-to-severe psoriasis, regardless of prior exposure to biologics or NBS. Secukinumab had a comparable safety profile to both etanercept and ustekinumab.",2020,"Secukinumab generated greater responses in biologic-naïve patients, while prior NBS had a negligible impact on treatment response.","['1,383 patients were included in the secukinumab versus placebo meta-analysis', 'Four subgroups of patients were assessed: 1) naïve to non-biologic systemics (NBS) and biologics', 'patients with moderate-to-severe psoriasis']","['secukinumab with placebo', 'secukinumab versus etanercept', 'etanercept', 'secukinumab with placebo, ustekinumab or etanercept', 'secukinumab', 'placebo', 'secukinumab treatment', 'placebo, etanercept and ustekinumab']","['Safety', ""Investigator's Global Assessment (IGA) score, absolute Psoriasis Area and Severity Index (PASI) response, PASI 75, 90 and 100 response and Dermatology Life Quality Index (DLQI"", 'biologic-naïve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]",1383.0,0.190358,"Secukinumab generated greater responses in biologic-naïve patients, while prior NBS had a negligible impact on treatment response.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hampton', 'Affiliation': 'Newcastle Dermatology, Newcastle Hospitals NHS Trust, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Halliday', 'Affiliation': 'Novartis Pharmaceuticals UK Limited, Surrey, United Kingdom.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Aassi', 'Affiliation': 'Novartis Pharma AG, Basel.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dermatology, The University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16982']
2971,33026748,Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients.,"BACKGROUND


There is a need for further evaluation of hyaluronic acid fillers for aesthetic use in Asia, where treatment goals may differ from western countries.
OBJECTIVE


To evaluate 24-month safety and effectiveness of two hyaluronic acid fillers with lidocaine when used for full-face aesthetic treatment in Asian patients.
METHODS


This was a 24-month, evaluator-blinded, non-comparative, multi-center study. Female subjects were injected with 3-5 mL Restylane&reg; Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHA&trade; technology, in 2&ndash;4 pre-defined areas; upper cheeks, nasolabial folds, temples, nose, and chin. A second treatment was performed after 12 months. Assessments included aesthetic improvement, subject satisfaction, assessment scales for upper cheeks and nasolabial folds, and safety (adverse events and subject diaries).
RESULTS


One hundred subjects were included; total mean volumes were 4.7 mL and 3.1 mL at first and second treatment, respectively. At least 82% of subjects were rated as aesthetically improved over 24 months by subjects themselves and by investigators. Most subjects (73-90%) were satisfied with the treatment throughout the study. Upper cheek improvement 12 months after treatment was significantly higher after second treatment (&ge;69% of subjects) than after first treatment (&ge;38%), P&lt;0.0001, Fisher&rsquo;s exact test. A total of 29 treatment related adverse events were reported by 16% of subjects, all were mild (79%) or moderate (21%) in intensity. Most commonly reported were pain and bruising. Tenderness was the most common diary record in all treatment areas.
CONCLUSION


Full-face treatments with the study products resulted in long-term aesthetic improvement, perceived by both subjects and investigators. Subject satisfaction was high and maintained over 24 months with one re-treatment. Repeated treatment of several facial indications showed a satisfactory safety profile. J Drugs Dermatol. 2020;19(9):836-842. doi:10.36849/JDD.2020.5374.",2020,"Upper cheek improvement 12 months after treatment was significantly higher after second treatment (&ge;69% of subjects) than after first treatment (&ge;38%), P&lt;0.0001, Fisher&rsquo;s exact test.","['Asian Patients', 'One hundred subjects were included', 'Asian patients', 'Female subjects']","['3-5 mL Restylane&reg; Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHA&trade; technology', 'hyaluronic acid fillers', 'hyaluronic acid fillers with lidocaine', 'Hyaluronic Acid Fillers With Lidocaine']","['total mean volumes', 'Subject satisfaction', 'adverse events', 'aesthetic improvement, subject satisfaction, assessment scales for upper cheeks and nasolabial folds, and safety (adverse events and subject diaries', 'satisfactory safety profile', 'pain and bruising', 'Tenderness']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1101698', 'cui_str': 'Restylane'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",100.0,0.0264866,"Upper cheek improvement 12 months after treatment was significantly higher after second treatment (&ge;69% of subjects) than after first treatment (&ge;38%), P&lt;0.0001, Fisher&rsquo;s exact test.","[{'ForeName': 'She-Hung', 'Initials': 'SH', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Tsen-Fang', 'Initials': 'TF', 'LastName': 'Tsai', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5374']
2972,33026749,Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis.,"OBJECTIVE


To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.
METHODS


A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician&rsquo;s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments &ndash; Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) &ndash; and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.
RESULTS


28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of &ldquo;clear&rdquo; or &ldquo;almost clear&rdquo; (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.
CONCLUSIONS


In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.",2020,Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%;,"['patients with moderate psoriasis (Physician&rsquo;s Global Assessment [PGA] score of 3', '28 subjects were enrolled (mean age, 64 years; 67.9% males']","['Calcipotriene 0.005%/Betamethasone', 'betamethasone dipropionate', 'Dipropionate', 'Cal/BD foam plus apremilast or vehicle foam plus apremilast']","['efficacy and safety', 'Efficacy and Safety', 'VAS score', 'safe and well tolerated', 'Efficacy assessments &ndash; Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) &ndash; and safety', 'BSA and QoL improvements', 'PGA score of &ldquo;clear&rdquo; or &ldquo;almost clear&rdquo', 'PASI75']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517414', 'cui_str': '0.064'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",28.0,0.0401037,Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%;,"[{'ForeName': 'Leon H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': ''}, {'ForeName': 'Todd E', 'Initials': 'TE', 'LastName': 'Schlesinger', 'Affiliation': ''}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Tanghetti', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.10.36849/JDD.2020.5020']
2973,33026940,How to Choose the Right Treatment for Patients With Advanced Squamous Cell Carcinoma in the Absence of a Comparative Randomized Clinical Trial.,,2020,,['Patients With Advanced Squamous Cell Carcinoma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]",[],[],,0.0406972,,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02137']
2974,33027046,Spinal and general anesthesia produces differential effects on oxidative stress and inflammatory cytokines in orthopedic patients.,"Objectives The contribution of anesthetic procedure to surgical stress and postoperative complications has been attributed to increased oxidative stress and release of inflammatory cytokines. Thus, the levels of oxidative stress biomarkers and inflammatory cytokines in patients with general anesthesia (GA) and spinal anesthesia (SA) that underwent open reduction and internal fixation (ORIF) in orthopedic surgery at Federal Teaching Hospital, Ido-Ekiti, Ekiti state, Nigeria were investigated. Methods Forty patients were randomly distributed into two groups (n = 20) namely GA and SA. Blood samples were collected before and after surgery for estimation of glucose, oxidative stress biomarkers (malondialdehyde [MDA], glutathione, catalase and nitrile) and inflammatory cytokines (tumor necrosis factor-α [TNF-α] and interleukin-6) levels. Results The post-operative blood glucose level was higher than the pre-operative value (p<0.5) in the two groups. There were significant (p<0.05) changes in MDA concentration and catalase activity in patients with GA in the post-operative stage relative to preoperative phase. There were no significant differences in glutathione, nitrite and interleukin-6 contents between the two groups. The patients with SA had higher levels of TNF-α in the post-operative stage. Conclusions These findings suggest that anesthesia has differential effects on oxidative stress and inflammatory cytokines in patients with ORIF orthopedic surgery.",2020,There were significant (p<0.05) changes in MDA concentration and catalase activity in patients with GA in the post-operative stage relative to preoperative phase.,"['Methods Forty patients', 'patients with general anesthesia (GA) and spinal anesthesia (SA) that underwent', 'orthopedic patients', 'patients with ORIF orthopedic surgery']",['open reduction and internal fixation (ORIF'],"['glutathione, nitrite and interleukin-6 contents', 'glucose, oxidative stress biomarkers (malondialdehyde [MDA], glutathione, catalase and nitrile) and inflammatory cytokines (tumor necrosis factor-α [TNF-α] and interleukin-6) levels', 'levels of TNF-α', 'post-operative blood glucose level', 'oxidative stress biomarkers and inflammatory cytokines', 'MDA concentration and catalase activity', 'oxidative stress and inflammatory cytokines']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0028131', 'cui_str': 'Nitrile'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0248283,There were significant (p<0.05) changes in MDA concentration and catalase activity in patients with GA in the post-operative stage relative to preoperative phase.,"[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Aremu', 'Affiliation': 'Neuropharmacology Unit, Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Abayomi M', 'Initials': 'AM', 'LastName': 'Ajayi', 'Affiliation': 'Neuropharmacology Unit, Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Benneth', 'Initials': 'B', 'LastName': 'Ben-Azu', 'Affiliation': 'Department of Pharmacology, Faculty of Basic Medical Sciences, PAMO University of Medical Sciences, Port Harcourt, Rivers State, Nigeria.'}, {'ForeName': 'Olayinka T', 'Initials': 'OT', 'LastName': 'Orewole', 'Affiliation': 'Anaesthesia and Intensive Care Department, Federal Teaching Hospital, Ido-Ekiti, Ekiti State, Nigeria.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Umukoro', 'Affiliation': 'Neuropharmacology Unit, Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",Drug metabolism and personalized therapy,['10.1515/dmdi-2020-0134']
2975,33027155,Examining the longitudinal predictive relationship between HIV treatment outcomes and pre-exposure prophylaxis use by serodiscordant male couples.,"BACKGROUND


Men who have sex with men are disproportionately burdened by HIV/AIDS, and the advent of pre-exposure prophylaxis (PrEP) has provided an effective strategy to reduce the risk of HIV transmission. Research has shown that improving one partner's health-promoting behaviors increases the likelihood that their partner adopts healthier behaviors. We examined the longitudinal relationship between favorable HIV treatment outcomes with current PrEP use among HIV serodiscordant male partners.
SETTING


Data are from Project Stronger Together, a randomized controlled trial that recruited serodiscordant male couples from Atlanta, GA, Boston, MA, and Chicago, IL.
METHODS


Serodiscordant couples completed assessments at baseline, 6, 12, 18, and 24 months. We analyzed longitudinal data from 120 HIV serodiscordant male partners to assess the relationship between the HIV-negative partner's current PrEP use and their HIV-positive partner's current ART use, ART adherence, and viral load using generalized estimating equation models.
RESULTS


Fewer than half of the HIV-negative partners were on PrEP at baseline and nearly two-thirds of their HIV-positive partners were virally suppressed. HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user compared to HIV-negative partners with partners with a detectable viral load.
CONCLUSION


Our study highlights the need develop dyad-level interventions to improve HIV medication use/adherence by HIV serodiscordant male couples. Our findings also suggest that dyad-level interventions may be able to leverage our understanding of how partners can influence each other's health-promoting behaviors to develop programs that improve health outcomes for both partners.",2020,"HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user compared to HIV-negative partners with partners with a detectable viral load.
","['HIV serodiscordant male couples', 'HIV serodiscordant male partners', 'serodiscordant male couples', 'HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user compared to HIV-negative partners with partners with a detectable viral load', 'Men who have sex with men', '120 HIV serodiscordant male partners']",[],[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C4319550', 'cui_str': '120'}]",[],[],120.0,0.0534616,"HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user compared to HIV-negative partners with partners with a detectable viral load.
","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biello', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lurie', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Systems, Population and Leadership & The Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, RI.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002522']
2976,33027156,Behavioral interventions can mitigate adverse pregnancy outcomes among women conceiving on antiretroviral therapy (ART) and those initiated on ART during pregnancy: Findings from the MOTIVATE trial in southwestern Kenya.,"BACKGROUND


Antiretroviral treatment (ART) is essential for the elimination of mother-to-child transmission and improved health outcomes for women living with HIV (WLWH). However, adverse pregnancy outcomes (APO) among pregnant women on ART are a growing concern.
METHODS


We investigated the associations between timing of ART initiation and APO among pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya. Log binomial models were used for estimation of relative risks (RRs) (adjusted for the clustered nature of data) evaluating APO with three exposure comparisons 1) Preconception ART initiation vs. post-conception initiation, 2) among post-conception ART initiating women, comparisons across gestational ages at cART initiation (first versus second and third trimester exposure) and, 3) intervention allocation.
RESULTS


Of the 1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths and 11 miscarriages. In multivariable analysis, viral load >1000 copies/ml, moderate and severe anemia at baseline increased risk of APO. Among women initiating ART before and after conception, no difference was observed in the composite APO. Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
CONCLUSIONS


Receiving supportive behavioral interventions may mitigate the risk of experiencing an APO among WLWH on ART. Further studies are needed to investigate the underlying mechanisms and optimize the benefits of these interventions.",2020,"Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
","['1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths and 11 miscarriages', 'pregnant women', 'women living with HIV (WLWH', 'women conceiving on antiretroviral therapy (ART) and those initiated on ART during pregnancy: Findings from the MOTIVATE trial in southwestern Kenya', 'pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya']",['Behavioral interventions'],"['adverse pregnancy outcomes (APO', 'risk of APO', 'composite APO', 'lower risks of experiencing any APO', 'moderate and severe anemia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",1275.0,0.257313,"Women who received community mentor mother visits only (aRR 0.74: 95% CI 0.71-0.76), or text messages only (aRR 0.79: 95% CI 0.70-0.89) had lower risks of experiencing any APO.
","[{'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Odwar', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wahome', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Elizabeth Anne', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hampanda', 'Affiliation': 'Department of Community and Behavioral Health, School of Public Health, University of Colorado Denver, Aurora, United States.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Policy and Organization, School of Public Health, University of Alabama at Birmingham, Birmingham, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver, Aurora, United States.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002521']
2977,33027166,What Factors Increase Revision Surgery Risk When Treating Displaced Femoral Neck Fractures With Arthroplasty: A Secondary Analysis of the HEALTH Trial.,"OBJECTIVES


HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture.
METHODS


We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable.
RESULTS


Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05).
CONCLUSION


Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months.","['low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome', 'low-energy displaced femoral neck fracture patients', 'our elderly and predominately female patient population', 'Displaced Femoral Neck Fractures With Arthroplasty']",['total hip arthroplasty with hemiarthroplasty'],"['risk of revision surgery', 'Revision Surgery Risk']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",1441.0,0.255039,"RESULTS


Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blankstein', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont Medical Center, South Burlington, VT.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Schottel', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont Medical Center, South Burlington, VT.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001936']
2978,33032712,Ticagrelor or Prasugrel in Patients With Acute Coronary Syndromes and Diabetes Mellitus.,"OBJECTIVES


The aim of this study was to assess the efficacy and safety of ticagrelor versus prasugrel in patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned.
BACKGROUND


The efficacy and safety of ticagrelor versus prasugrel in patients with ACS with DM undergoing invasive treatment remain unknown.
METHODS


This pre-specified analysis of the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial included 892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to prasugrel or ticagrelor. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding (both assessed 12 months after randomization).
RESULTS


The primary endpoint occurred in 51 patients (11.2%) in the ticagrelor group and 55 patients (13.0%) in the prasugrel group in the DM cohort (hazard ratio: 0.84; 95% confidence interval: 0.58 to 1.24; p = 0.383) and in 132 patients (8.6%) in the ticagrelor group and 81 patients (5.2%) in the prasugrel group in the non-DM cohort (hazard ratio: 1.70; 95% confidence interval: 1.29 to 2.24; p < 0.001). There was a significant treatment arm-by-diabetic status interaction (p int  = 0.0035). Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500).
CONCLUSIONS


DM seems to affect the efficacy of ticagrelor and prasugrel in patients with ACS. In patients with DM, the efficacy of ticagrelor was comparable with that of prasugrel. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome [ISAR-REACT 5]; NCT01944800).",2020,"Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500).
","['Coronary Treatment', 'Patients With Acute Coronary Syndrome [ISAR-REACT 5', 'Patients With Acute Coronary Syndromes and Diabetes\xa0Mellitus', '892 patients with ACS with DM and 3,124 patients with ACS without DM randomized to', 'patients with ACS', 'patients with diabetes mellitus (DM) presenting with acute coronary syndromes (ACS) in whom invasive therapy was planned', 'patients with ACS with DM undergoing invasive treatment remain unknown']","['ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen', 'prasugrel or ticagrelor', 'prasugrel', 'ticagrelor', 'Ticagrelor Versus Prasugrel', 'Ticagrelor or Prasugrel']","['efficacy and safety', 'composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding']","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",892.0,0.0776647,"Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 27 patients (6.9%) in the ticagrelor group and 19 patients (5.5%) in the prasugrel group (p = 0.425) in the DM cohort and in 68 patients (5.2%) in the ticagrelor group and 60 patients (4.6%) in the prasugrel group in the non-DM cohort (p = 0.500).
","[{'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: kastrati@dhm.mhn.de.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone, Italy.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Department of Cardiology, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Departments of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Department of Cardiology, Klinik der Universität München, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Gewalt', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany; German Center for Cardiovascular Research, Partner Site Rhine-Main, Frankfurt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of General Practice and Health Services Research, Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany; Technische Universität München, Munich, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.032']
2979,33032714,Long-Term Prognostic Impact of Restenosis of the Unprotected Left Main Coronary Artery Requiring Repeat Revascularization.,"OBJECTIVES


The aim of this study was to evaluate the prognostic impact of target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA) after stent failure.
BACKGROUND


Although drug-eluting stents are safe and effective for treatment of the ULMCA, increased rates of repeat revascularization have been observed.
METHODS


This is a patient-level pooled analysis of the randomized ISAR-LEFT-MAIN (Drug-Eluting-Stents for Unprotected Left Main Stem Disease) and ISAR-LEFT-MAIN-2 (Drug-Eluting Stents to Treat Unprotected Coronary Left Main Disease) trials, in which patients underwent stenting of the ULMCA. The present analysis includes patients who underwent angiography during follow-up. Patients with TLR were compared with those without. Additional long-term clinical follow-up after TLR was conducted, and its influence on mortality was evaluated. Mortality was calculated using the Kaplan-Meier method. Predictors of mortality were assessed in a multivariate analysis.
RESULTS


A total of 1,001 patients were eligible, of whom 166 experienced TLR. The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001). In the multivariate analysis, glomerular filtration rate (-30 ml/min; hazard ratio [HR]: 2.25; 95% confidence interval [CI]: 1.54 to 3.27; p < 0.001), chronic obstructive pulmonary disease (HR: 4.95; 95% CI: 1.33 to 18.42; p = 0.02), and body mass index (+5 kg/m 2 ; HR: 1.61; 95% CI: 1.12 to 2.32; p = 0.01) were independent predictors of mortality after TLR due to left main stent failure. The type of repeat revascularization and the underlying stent did not influence the mortality after TLR of the ULMCA.
CONCLUSIONS


Mortality after TLR for left main stent failure is high. Patient-related factors seem to have a greater impact on mortality after TLR than other variables.",2020,The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001).,"['A total of 1,001 patients were eligible, of whom 166 experienced TLR', 'patients who underwent angiography during follow-up']",['target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA'],"['Mortality', 'body mass index', 'glomerular filtration rate', '5-year mortality rate', 'chronic obstructive pulmonary disease']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",1001.0,0.385046,The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001).,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: wiebe@dhm.mhn.de.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Kuna', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': '1. Med. Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lösl', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Mater Private Hospital, Department of Cardiology, Dublin, Ireland; Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; 1. Med. Klinik, Klinikum Rechts der Isar, Technische Universität, Munich, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Centre Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Julinda', 'Initials': 'J', 'LastName': 'Mehilli', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Department of Cardiology, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.017']
2980,33032722,Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents for Primary PCI: A Subgroup Analysis of the BIOSTEMI Randomized Trial.,,2020,,['Primary PCI'],['Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents'],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]",[],,0.117794,,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Losdat', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kurz', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.038']
2981,33032770,Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE Trial.,"OBJECTIVE


Evaluate the effect of intravenous golimumab on health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS) through week 28 of the phase III, multicenter, randomized, double-blind, placebo-controlled GO-ALIVE study.
METHODS


Adult patients (n = 208) were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, and 12 and every 8 weeks or placebo (n = 103) at weeks 0, 4, and 12, with crossover to golimumab 2mg/kg at weeks 16, 20, and every 8 weeks. General HRQoL was evaluated using the Short Form Health Survey (SF-36) Physical Component Summary/Mental Component Summary (PCS/MCS), and the EQ VAS, and AS disease-specific HRQoL was assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) instrument.
RESULTS


Mean improvements from baseline in SF-36 PCS were greater in the golimumab group versus the placebo group at weeks 8 and 16 (6.8 vs 2.1 and 8.5 vs 2.9, respectively; P < .001); similar results were observed for SF-36 MCS (5.6 vs 1.7 and 6.5 vs 0.8, respectively; P < .001). Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16. Mean improvements in EQ VAS and ASQoL were greater in the golimumab group versus placebo at week 8 and week 16. Greater proportions of golimumab-treated patients had clinically meaningful improvement in SF-36 PCS, SF-36 MCS, EQ VAS, and ASQoL at weeks 8 and 16; improvements in SF-36 PCS/MCS, EQ VAS, and ASQoL were maintained through week 28.
CONCLUSIONS


Golimumab-treated patients had greater mean improvements in HRQoL measures compared with placebo through week 16. Clinically meaningful improvements were observed as early as week 8 and continued through week 28.",2020,Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16.,"['Adult patients (n\xa0= 208', 'patients with ankylosing spondylitis (AS', 'Patients with Ankylosing Spondylitis']","['intravenous golimumab', 'Intravenous Golimumab', 'placebo', 'IV golimumab']","['SF-36 MCS', 'SF-36 PCS', 'Ankylosing Spondylitis Quality of Life (ASQoL) instrument', 'EQ VAS and ASQoL', 'SF-36 PCS, SF-36 MCS, EQ VAS, and ASQoL at weeks 8 and 16; improvements in SF-36 PCS/MCS, EQ VAS, and ASQoL', 'health-related quality of life (HRQoL', 'Health-Related Quality of Life', 'HRQoL measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",208.0,0.25509,Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'University of Texas McGovern Medical School, Houston, TX, United States.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Akgun', 'Initials': 'A', 'LastName': 'Ince', 'Affiliation': 'Arthritis Consultants, St. Louis, MO, United States.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chan', 'Affiliation': 'Janssen Global Services, LLC, Raritan, NJ, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States; University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, United States.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Malvern, PA, United States. Electronic address: chan3@its.jnj.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.04.1837']
2982,33032771,Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients With Psoriatic Arthritis: 24-Week Results of the GO-VIBRANT Trial.,"OBJECTIVES


Evaluate the effects of intravenous golimumab 2 mg/kg on multiple domains of health-related quality of life (HRQoL) in adult patients with active psoriatic arthritis (PsA).
METHODS


In this phase III, randomized, double-blinded, placebo-controlled study, adults with active PsA were randomized in a 1:1 ratio to receive intravenous (IV) infusions of placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Physical function was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). HRQoL was assessed using the 36-item Short-Form Health Survey Physical and Mental Component Summary (SF-36 PCS/MCS) scores, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EQ VAS, and the Dermatology Life Quality Index (DLQI).
RESULTS


Patients in the golimumab group had greater mean changes from baseline in HAQ-DI compared with placebo at weeks 8 (-0.52 vs -0.10), 14 (-0.60 vs -0.12), and 24 (-0.63 vs -0.14). Mean improvements from baseline in SF-36 PCS (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 2.0), and DLQI (-7.2 vs -1.7) were also greater in the golimumab group versus placebo at week 8 and were maintained or increased through week 24. Greater proportions of golimumab-treated patients had improvements greater than or equal to the minimal clinically important difference (MCID) for HAQ-DI, SF-36 PCS/MCS, EQ VAS, FACIT-Fatigue, and DLQI scores at weeks 14 and 24.
CONCLUSION


Improvements in HRQoL were greater in the IV golimumab group compared with placebo and were evident at week 8 and sustained through week 24.",2020,"Mean improvements from baseline in SF-36 PCS (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 2.0), and DLQI (-7.2 vs -1.7) were also greater in the golimumab group versus placebo at week 8 and were maintained or increased through week 24.","['Patients With Psoriatic Arthritis', 'adult patients with active psoriatic arthritis (PsA', 'adults with active PsA']","['intravenous (IV) infusions of placebo', 'placebo', 'intravenous golimumab', 'Intravenous Golimumab', 'golimumab']","['HAQ-DI, SF-36 PCS/MCS, EQ VAS, FACIT-Fatigue, and DLQI scores', '36-item Short-Form Health Survey Physical and Mental Component Summary (SF-36 PCS/MCS) scores, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EQ VAS, and the Dermatology Life Quality Index (DLQI', 'SF-36 MCS', 'SF-36 PCS', 'EQ VAS', 'FACIT-Fatigue', 'health-related quality of life (HRQoL', 'HRQoL', 'Health-Related Quality of Life', 'HAQ-DI', 'Physical function', 'Health Assessment Questionnaire-Disability Index (HAQ-DI', 'DLQI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}]","[{'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.348431,"Mean improvements from baseline in SF-36 PCS (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 2.0), and DLQI (-7.2 vs -1.7) were also greater in the golimumab group versus placebo at week 8 and were maintained or increased through week 24.","[{'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chan', 'Affiliation': 'Janssen Global Services LLC, Raritan, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA; University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Malvern, PA, USA. Electronic address: chan3@its.jnj.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.06.007']
2983,33032885,"Voice-Related Quality of Life, Anxiety, and Depression in Female Teachers: Finger Kazoo Intensive Short-Term Vocal Therapy.","BACKGROUND


Among professional voice users, teachers are subject to higher risks of developing occupational dysphonia due to their abusive use of the voice, usually under unfavorable conditions.
OBJECTIVES


Quantify the vocal self-perception, the voice-related quality of life, and the anxiety, and depression symptoms, of dysphonic female teachers, after a brief and intensive short-term voice therapy using the finger kazoo technique.
METHODS


Blinded, randomized, and controlled clinical trial. Questionnaires applied to two study groups (15 subjects without structural laryngeal disorder in one group, and nine subjects with vocal nodules in the other), and to two control groups (9 subjects without structural laryngeal disorder in one group, and eight subjects with vocal nodules in the other).
RESULTS


The Vocal Tract Discomfort Scale, the Voice Activity and Participation Profile, the Voice Symptom Scale, and the Voice-Related Quality of Life Protocol, showed significant improvement in both study groups. The Vocal Perception Protocol showed that negative vocal self-perception reduced significantly in subjects without structural alteration of the vocal folds in the study group. Anxiety symptoms improved significantly in subjects with vocal nodules in the study group; depression symptoms improved significantly in subjects with vocal nodules in the control group, and in subjects without structural alteration of the vocal folds in the study group.
CONCLUSION


Brief and intensive short-term voice therapy using the finger kazoo technique provided improvement in the vocal self-perception, the voice-related quality of life, and in the symptoms of anxiety and depression in dysphonic teachers, more evidently in teachers with vocal nodules.",2020,"Anxiety symptoms improved significantly in subjects with vocal nodules in the study group; depression symptoms improved significantly in subjects with vocal nodules in the control group, and in subjects without structural alteration of the vocal folds in the study group.
","['15 subjects without structural laryngeal disorder in one group, and nine subjects with vocal nodules in the other), and to two control groups (9 subjects without structural laryngeal disorder in one group, and eight subjects with vocal nodules in the other', 'Female Teachers']","['Kazoo Intensive Short-Term Vocal Therapy', 'Brief and intensive short-term voice therapy using the finger kazoo technique', 'intensive short-term voice therapy using the finger kazoo technique']","['vocal self-perception, the voice-related quality of life, and the anxiety, and depression symptoms', 'Voice-Related Quality of Life, Anxiety, and Depression', 'negative vocal self-perception', 'depression symptoms', 'vocal self-perception, the voice-related quality of life', 'Vocal Tract Discomfort Scale, the Voice Activity and Participation Profile, the Voice Symptom Scale, and the Voice-Related Quality of Life Protocol', 'Anxiety symptoms']","[{'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",15.0,0.0172938,"Anxiety symptoms improved significantly in subjects with vocal nodules in the study group; depression symptoms improved significantly in subjects with vocal nodules in the control group, and in subjects without structural alteration of the vocal folds in the study group.
","[{'ForeName': 'Mara Keli', 'Initials': 'MK', 'LastName': 'Christmann', 'Affiliation': 'Universidade do Vale do Itajaí (UNIVALI), Itajaí, SC, Brazil; Associação Educacional Luterana Bom Jesus (IELUSC), Joinville, SC, Brazil; Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil. Electronic address: marakchristmann@gmail.com.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Scapini', 'Affiliation': 'Departamento de Clínica Médica, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Joziane Padilha de Moraes', 'Initials': 'JPM', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Bruna Franciele da Trindade', 'Initials': 'BFDT', 'LastName': 'Gonçalves', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Gabriele Rodrigues', 'Initials': 'GR', 'LastName': 'Bastilha', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Carla Aparecida', 'Initials': 'CA', 'LastName': 'Cielo', 'Affiliation': 'Departamento de Fonoaudiologia, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.08.039']
2984,33032897,A Randomised Controlled Trial of Chewing Gum to Relieve Thirst in Chronic Heart Failure (RELIEVE-CHF).,"BACKGROUND


Thirst is a common and troublesome symptom of patients with chronic heart failure (CHF). To date, there are no interventions to help alleviate thirst in this cohort. Chewing gum is a novel intervention, which has been tested in people undergoing haemodialysis, also prescribed with a fluid restricted therapy. The aim of this study was to determine the effect of chewing gum on the level of thirst in the short-term (average of 24 hours each day for 4 days) and in the longer-term (Days 7, 14 and 28) individuals with CHF.
METHODS


Seventy-one (71) individuals with CHF on oral loop diuretics were randomised to chewing gum (n=36) or control (n=35) for 2 weeks. Both groups were assessed for their level of thirst at Days 1-4, 7, 14 and 28.
RESULTS


Significant improvements in the level of thirst of those who received chewing gum compared to the control group at Day 4 (p=0.04) and Day 14 (p=0.02) were observed.
CONCLUSION


Chewing gum provided relief from thirst in the short-term and in the longer term. This trial provides important information to inform future clinical trials on ways to relieve thirst.",2020,"RESULTS


Significant improvements in the level of thirst of those who received chewing gum compared to the control group at Day 4 (p=0.04) and Day 14 (p=0.02) were observed.
","['14 and 28) individuals with CHF', 'patients with chronic heart failure (CHF', 'people undergoing haemodialysis', 'Seventy-one (71) individuals with CHF on oral loop diuretics']","['chewing gum', 'Chewing Gum', 'Chewing gum', 'chewing gum (n=36) or control']",['level of thirst'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}]","[{'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}]",,0.0365649,"RESULTS


Significant improvements in the level of thirst of those who received chewing gum compared to the control group at Day 4 (p=0.04) and Day 14 (p=0.02) were observed.
","[{'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Allida', 'Affiliation': 'Neurological and Mental Health Division, The George Institute for Global Health, Sydney, NSW, Australia; IMPACCT Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia. Electronic address: sallida@georgeinstitute.org.au.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Shehab', 'Affiliation': 'Cardiac Diagnostic Service, Blacktown Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Sally C', 'Initials': 'SC', 'LastName': 'Inglis', 'Affiliation': 'IMPACCT Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Davidson', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Hayward', 'Affiliation': ""Cardiology Department, St. Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Newton', 'Affiliation': 'Nursing Research Centre, Western Sydney University, Sydney, NSW, Australia.'}]","Heart, lung & circulation",['10.1016/j.hlc.2020.09.004']
2985,33032908,Alpha-lipoic acid improves sperm motility in infertile men after varicocelectomy: a triple-blind randomized controlled trial.,"RESEARCH QUESTION


Does supplementation with alpha-lipoic acid (ALA) enhance sperm parameters and/or the status of sperm lipid peroxidation and DNA fragmentation in men who have undergone microsurgical repair of a varicocele?
DESIGN


Individuals with a varicocele who had undergone varicocelectomy were divided into two groups receiving either 600 mg of ALA or an identical placebo for 80 days. Semen samples obtained from the participants before surgery and after completion of the course of medication were analysed and compared. Participants, clinicians and data analysts were blinded to the randomization sequence.
RESULTS


In the ALA group, total motility (P = 0.01) and progressive motility (P = 0.002) of the spermatozoa were significantly higher compared with the placebo group after surgery. Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
CONCLUSIONS


An 80-day course of ALA medication after surgical repair improves total motility and progressive motility of the spermatozoa in individuals with a varicocele.",2020,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","['individuals with a varicocele', 'Individuals with a varicocele who had undergone varicocelectomy', 'men who have undergone microsurgical repair of a varicocele', 'infertile men after varicocelectomy']","['placebo', 'alpha-lipoic acid (ALA', '600\xa0mg of ALA or an identical placebo', 'Alpha-lipoic acid']","['total motility and progressive motility', 'progressive motility', 'Sperm lipid peroxidation and DNA damage', 'sperm motility', 'total motility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}]",,0.50103,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Abbasi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Newsha', 'Initials': 'N', 'LastName': 'Molavi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Tavalaee', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Abbasi', 'Affiliation': 'Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran. Electronic address: mh.nasr-esfahani@royaninstitute.org.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.013']
2986,33032917,The use of an activity tracker to objectively measure inpatient activity after bariatric surgery.,"BACKGROUND


Early postoperative ambulation reduces length of stay and prevents postoperative complications after bariatric surgery. Rarely is postoperative inpatient activity objectively measured despite readily available commercial activity trackers.
OBJECTIVES


Evaluate the impact of using activity trackers to record number of inpatient steps taken after bariatric surgery and assess how patient characteristics may affect the number of steps recorded.
SETTING


University Hospital, United States.
METHODS


Using an activity tracker, the number of steps taken during the postoperative hospital stay was recorded for 235 patients undergoing either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Patients were randomly assigned to either being informed about the devices' ability to record the number of steps taken or blinded to the purpose of the devices. Descriptive statistics were used to summarize study sample, a t test was used to compare number of steps recorded between groups, and a multivariate regression model was used to examine the effect of age, sex, preoperative body mass index (BMI), types of surgery, and length of stay on number of steps recorded.
RESULTS


One hundred twenty-five patients (52.8%) were randomized to the blinded group while 111 (47.2%) were informed that the device would record the number of steps taken. There were no differences in the number of steps recorded between the 2 groups. Patients with prolonged length of stay recorded lower numbers of steps taken on postoperative day 0. Increasing age was seen to reduce the number of steps recorded on postoperative day number 1. There were no significant differences in number of steps recorded based on sex, preoperative BMI, or surgery type.
CONCLUSION


The present study found that knowledge of an activity tracker being used did not affect the patient's activity level as measured by steps recorded. Increasing age correlated to reduced number of steps recorded on postoperative day 1 after bariatric surgery.",2020,There were no differences in the number of steps recorded between the 2 groups.,"['235 patients undergoing either', 'University Hospital, United States', 'One hundred twenty-five patients (52.8']","['activity tracker', 'laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy']","['number of steps', ""patient's activity level"", 'preoperative body mass index (BMI), types of surgery, and length of stay on number of steps recorded', 'number of steps recorded based on sex, preoperative BMI, or surgery type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",235.0,0.0398186,There were no differences in the number of steps recorded between the 2 groups.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Tabone', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States. Electronic address: letabone@hsc.wvu.edu.'}, {'ForeName': 'Jiyoung K', 'Initials': 'JK', 'LastName': 'Tabone', 'Affiliation': 'School of Social Work, West Virginia University, Morgantown, West Virginia, United States.'}, {'ForeName': 'Nova', 'Initials': 'N', 'LastName': 'Szoka', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abunnaja', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Surgery, West Virginia University School of Medicine, Morgantown, West Virginia, United States.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.08.033']
2987,33032927,Preliminary Evidence That Cortical Amyloid Burden Predicts Poor Response to Antidepressant Medication Treatment in Cognitively Intact Individuals With Late-Life Depression.,"OBJECTIVE


Amyloid accumulation, the pathological hallmark of Alzheimer's disease, may predispose some older adults to depression and cognitive decline. Deposition of amyloid also occurs prior to the development of cognitive decline. It is unclear whether amyloid influences antidepressant outcomes in cognitively intact depressed elders.
DESIGN


A pharmacoimaging trial utilizing florbetapir (18F) PET scanning followed by 2 sequential 8-week antidepressant medication trials.
PARTICIPANTS


Twenty-seven depressed elders who were cognitively intact on screening.
MEASUREMENTS AND INTERVENTIONS


After screening, diagnostic testing, assessment of depression severity and neuropsychological assessment, participants completed florbetapir (18F) PET scanning. They were then randomized to receive escitalopram or placebo for 8 weeks in a double-blinded two-to-one allocation rate. Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
RESULTS


Compared with 22 amyloid-negative participants, 5 amyloid-positive participants exhibited significantly less change in depression severity and a lower likelihood of remission. In the initial blinded trial, 4 of 5 amyloid-positive participants were nonremitters (80%), while only 18% (4 of 22) of amyloid-negative participants did not remit (p = 0.017; Fisher's Exact test). In separate models adjusting for key covariates, both positive amyloid status (t = 3.07, 21 df, p = 0.003) and higher cortical amyloid binding by standard uptake value ratio (t = 2.62, 21 df, p = 0.010) were associated with less improvement in depression severity. Similar findings were observed when examining change in depression status across both antidepressant trials.
CONCLUSIONS


In this preliminary study, amyloid status predicted poor antidepressant response to sequential antidepressant treatment. Alternative treatment approaches may be needed for amyloid-positive depressed elders.",2020,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
","['Individuals who did not respond to initial treatment transitioned to a second open-label trial of', 'Intact Individuals With Late-Life Depression', 'amyloid-positive depressed elders', 'Twenty-seven depressed elders who were cognitively intact on screening', 'cognitively intact depressed elders', 'Cognitively']","['florbetapir (18F) PET scanning', 'bupropion', 'escitalopram or placebo']","['depression status', 'depression severity and a lower likelihood of remission', 'cortical amyloid binding by standard uptake value ratio', 'depression severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C2742211', 'cui_str': 'florbetapir'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",27.0,0.194977,"Individuals who did not respond to initial treatment transitioned to a second open-label trial of bupropion for another 8 weeks.
","[{'ForeName': 'Warren D', 'Initials': 'WD', 'LastName': 'Taylor', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN. Electronic address: warren.d.taylor@vanderbilt.edu.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Boyd', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Elson', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Andrews', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Albert', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vega', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Newhouse', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN; Geriatric Research, Education, and Clinical Center (WDT, PAN), Veterans Affairs Tennessee Valley Health System, Nashville, TN.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Woodward', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Hakmook', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Biostatistics (HK), Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'The Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences (WDT, BDB, PA, KA, JV, PAN, NDW, HK, SS), Vanderbilt University Medical Center, Nashville, TN.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.09.019']
2988,33033007,Evaluating spillover of HIV knowledge from study participants to their network members in a stepped-wedge behavioural intervention in Tanzania.,"OBJECTIVES


We aim to describe the social network members of participants of a behavioural intervention, and examine how the effects of the intervention may spillover among network members.
DESIGN


Secondary analysis of a step-wedge randomised controlled trial.
SETTING


Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs.
PARTICIPANTS


We enrolled 662 CAs in an HIV behavioural intervention. They, along with 710 of their NMs, completed baseline and follow-up interviews from 2011 to 2013.
PRIMARY AND SECONDARY OUTCOMES


The primary outcome of this study was change in NMs' HIV knowledge, and the secondary outcome was whether the NM was lost to follow-up.
RESULTS


At baseline, many characteristics were different between NMs and CAs. We found a number of NM characteristics significantly associated with follow-up of NMs, particularly female gender (OR=1.64, 95% CI: 1.02 to 2.63) and HIV knowledge (OR=20.0, 95% CI: 3.70 to 125); only one CA variable was significantly associated with NM follow-up: having a private source of water (OR=2.17, 95% CI: 1.33 to 3.57). The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
CONCLUSIONS


Characteristics of social network members of persons living with HIV persons living with HIV may play a role in study retention. Additionally, the HIV knowledge of these NMs increased largely as a function of CA participation in the intervention, suggesting that intervening among highly-connected individuals may maximise benefits to the potential population for whom spillover can occur.
TRIAL REGISTRATION NUMBER


Clinical Trial: NCT01693458; Post-results.",2020,"The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
","['study participants to their network members in a stepped-wedge behavioural intervention in Tanzania', 'Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs', 'persons living with HIV persons living with HIV', 'social network members of participants of a', 'We enrolled 662 CAs in an HIV behavioural intervention']",['behavioural intervention'],"[""change in NMs' HIV knowledge"", 'HIV knowledge', 'number of NM characteristics', ""NMs' HIV knowledge""]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",662.0,0.189079,"The 14.2% increase in NMs' HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rewley', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA jeffrey.rewley@pennmedicine.upenn.edu.'}, {'ForeName': 'Mary C Smith', 'Initials': 'MCS', 'LastName': 'Fawzi', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Kaaya', 'Affiliation': 'School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of Texas School of Public Health, Austin, Texas, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Todd', 'Affiliation': 'Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Andrew', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jukka Pekka', 'Initials': 'JP', 'LastName': 'Onnela', 'Affiliation': 'Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033759']
2989,33033011,Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial.,"INTRODUCTION


Pregnancy loss (PL) is an adverse life event, and there is no proven effective treatment for recurrent PL (RPL). Preimplantation genetic screening (PGS) can be performed to reduce the risks of PL; however, there is still no solid scientific evidence that PGS improves outcomes for couples experiencing RPL. Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics. Previous studies based on PGS1.0 with a focus on RPL couples where the female is of advanced maternal age have reported contradictory results. Hence, a multicentre randomised trial is needed to provide evidence for the clinical benefits of PGS2.0 treatment for RPL couples.
METHODS AND ANALYSIS


Overall, 268 RPL couples undergoing IVF cycles will be enrolled. Couples will be randomised according to a unique grouping number generated by a random digital software into (1) PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation) group. This study aims to investigate whether the live birth rate (LBR) per initiated cycle after PGS2.0 is superior to the LBR per initiated cycle after conventional embryo evaluation (non-PGS group). Live birth will be defined as a live baby born after a gestation period of >28 weeks, with a birth weight of more than 1000 g. A multivariate logistic regression model will be used to adjust for confounding factors.
ETHICS AND DISSEMINATION


Ethical approval has been granted by the Ethics Committee of Obstetrics and Gynecology Hospital, Fudan University and the participating hospitals. Written informed consent will be obtained from each couple before any study procedure is performed. Data from this study will be stored in the Research Electronic Data Capture. The results of this trial will be presented and published via peer-reviewed publications and presentations at international conferences.
TRIAL REGISTRATION NUMBER


NCT03214185; Pre-results.",2020,Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics.,"['patients with recurrent pregnancy loss', '268 RPL couples undergoing IVF cycles will be enrolled']","['PGS2.0 group and (2) non-PGS (conventional embryo morphology evaluation', 'PGS', 'conventional embryo morphology evaluation', 'PGS2.0', 'Comprehensive chromosome screening (PGS2.0', 'Preimplantation genetic screening (PGS']",['live birth rate (LBR'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0813145', 'cui_str': 'Genetic Screening'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.365085,Comprehensive chromosome screening (PGS2.0) has become a routine practice in  in vitro  fertilisation (IVF) clinics.,"[{'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': 'Prenatal Diagnosis Center, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sui', 'Affiliation': 'Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China.'}, {'ForeName': 'Jiangfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Reproductive Medical Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Reproductive Medical Center, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Genetics, Shanghai JiAi Genetics & IVF Institute, Shanghai, China xiaoxi_sun@aliyun.com.'}]",BMJ open,['10.1136/bmjopen-2019-036252']
2990,33033014,Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol.,"INTRODUCTION


Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.
METHODS AND ANALYSIS


The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.
ETHICS AND DISSEMINATION


The study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'"". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov Identifier: NCT04079387; Pre-results.",2020,"The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation.",['critically ill patients'],"['orotracheal intubation', 'endotracheal tube alone', 'endotracheal tube plus stylet versus endotracheal tube alone', 'endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group', 'endotracheal tube plus stylet']","['successful first-attempt tracheal intubation', 'incidence of complications related to intubation, in the hour following intubation', 'mucosal bleeding, perforation of the trachea or oesophagus and sore throat', 'proportion of patients with successful first-attempt orotracheal intubation', 'safety, exploratory procedural and clinical outcomes']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.158153,"The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation.","[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France s-jaber@chu-montpellier.fr.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Rolle', 'Affiliation': 'Intensive Care & Anesthesiology Department, University of Pointe à Pitre Hospital. Guadeloupe, France, Université des Antilles Bibliothèque Hospitalo-universitaire de Guadeloupe, Pointe-a-Pitre, Guadeloupe.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Jung', 'Affiliation': 'PhyMed Exp, Université de Montpellier, INSERM U1046 Montpellier, France, Inserm U1046, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bertet', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Galeazzi', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chauveton', 'Affiliation': 'Clinical research department of Montpellier university hospital, Montpellier, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'De Jong', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.'}]",BMJ open,['10.1136/bmjopen-2019-036718']
2991,33033021,Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa.,"INTRODUCTION


Providing effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN.
METHODS AND ANALYSIS


The study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
ETHICS AND DISSEMINATION


The protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.",2020,"Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
","['patients hospitalised with anorexia nervosa (AN', 'adolescent and young adult patients (aged 15-25 years), hospitalised with AN', 'malnourished adolescent and young adults with AN', 'adolescent and young adults admitted with anorexia nervosa']","['lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate', 'hospital management', 'standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula']","['incidence of hypophosphatemia', 'efficacy and safety', 'safety and efficacy', 'weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters', 'nutritional intake, weight and biochemistry (phosphate, magnesium, potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C3714316', 'cui_str': 'Low carbohydrate enteral formula'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3714326', 'cui_str': 'Standard enteral formula'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0560598', 'cui_str': 'kcal/mL'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.109466,"Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parker', 'Affiliation': 'Department of Dietetics & Nutrition, Westmead Hospital, Westmead, New South Wales, Australia elizabeth.parker@health.nsw.gov.au.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flood', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Halaki', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wearne', 'Affiliation': 'Department of Medical Psychology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Linette', 'Initials': 'L', 'LastName': 'Gomes', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Sydney School of Medicine, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frig', 'Affiliation': 'Department of Nutrition and Dietetics, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kohn', 'Affiliation': 'Department of Adolescent & Young Adult Medicine, Westmead Hospital, Westmead, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038242']
2992,33033025,Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE).,"INTRODUCTION


Exercise interventions have been widely investigated in patients with cancer and demonstrate beneficial effects. However, intervention studies that include older women with breast cancer exercising during medical treatment are scarce. Hence, the aim of this study is to investigate the effect of a 12-week exercise-based intervention in older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy.
METHODS AND ANALYSIS


This is a single-centre, two-armed randomised controlled trial. We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors). The intervention group will receive standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts. The control group will receive standard oncological treatment. Assessments will be performed at baseline and 6, 12 and 24 weeks after start of the intervention. Primary outcome is physical function, measured by the 30-second Chair Stand Test. Secondary outcomes are feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival.
ETHICS AND DISSEMINATION


The protocol was reviewed and accepted by the Scientific Ethics Review Committee of the Capital Region of Denmark, 17 June 2018 (VEK ref.: H-18021013). Trial results will be submitted for publication in a peer-reviewed journal and presented on conferences, in oncology wards, exercise centres in municipalities and patient organisations, ensuring dissemination to relevant stakeholders.
TRIAL REGISTRATION NUMBER


https://clinicaltrials.gov/ on 3 September 2018. Identifier: NCT03656731.",2020,"We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors).","['older women with breast cancer during systemic therapy', 'older women with breast cancer', '100 patients', 'older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy', 'patients with cancer']","['standard oncological treatment', 'exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors', 'standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts', 'exercise-based intervention', 'Exercise']","['feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of', 'Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival', 'physical function, measured by the 30-second Chair Stand Test']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0456965', 'cui_str': '20 feet'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",,0.148979,"We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors).","[{'ForeName': 'Høgni Hammershaimb', 'Initials': 'HH', 'LastName': 'Andersen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark hoegni.hammershaimb.andersen@regionh.dk.'}, {'ForeName': 'Marta Kramer', 'Initials': 'MK', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Lundager', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Cecilia Margareta', 'Initials': 'CM', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Julia Sidenius', 'Initials': 'JS', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bogh Juhl', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zerahn', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Ragle', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Dorte Lisbet', 'Initials': 'DL', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-038674']
2993,33033029,"Strengthening integration of chronic care in Africa: protocol for the qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised controlled trial in Tanzania and Uganda.","INTRODUCTION


In sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions.
METHODS AND ANALYSIS


This protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services.
TRIAL REGISTRATION NUMBER


ISRCTN43896688; Pre-results.",2020,"Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV.",['young-middle-aged adults'],[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0648707,"Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV.","[{'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Van Hout', 'Affiliation': 'Public Health Institute, Liverpool John Moores University, Liverpool, Merseyside, UK M.C.VanHout@ljmu.ac.uk.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Lazarus', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clinic, University of Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Elizabeth Henry', 'Initials': 'EH', 'LastName': 'Shayo', 'Affiliation': 'Muhimbili Centre, National Institute for Medical Research, Dar es Salaam, Dar es Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Bukenya', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Camila A', 'Initials': 'CA', 'LastName': 'Picchio', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clinic, University of Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Moffat', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Sayoki Godfrey', 'Initials': 'SG', 'LastName': 'Mfinanga', 'Affiliation': 'Muhimbili Centre, National Institute for Medical Research, Dar es Salaam, Dar es Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Birungi', 'Affiliation': 'MRC/UVRI/LSHTM Uganda Research Unit, Medical Research Council Uganda, Entebbe, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Okebe', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}, {'ForeName': 'Shabbar', 'Initials': 'S', 'LastName': 'Jaffar', 'Affiliation': 'Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039237']
2994,33033035,"Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery.","INTRODUCTION


Myocardial protection against ischaemic-reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, with current strategies, myocardial injury occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. Remote ischaemic preconditioning, the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial will assess whether remote ischaemic preconditioning, applied to both lower limbs immediately prior to surgery, reduces myocardial injury in cyanotic and acyanotic young children.
METHODS AND ANALYSIS


The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect. Participants will be randomised in a 1:1 ratio to either bilateral remote ischaemic preconditioning (3×5 min cycles) or sham immediately prior to surgery, with follow-up until discharge from hospital or 30 days, whichever is sooner. The primary outcome is reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12 hours, and lengths of stay in the paediatric intensive care unit and the hospital.
ETHICS AND DISSEMINATION


The trial was approved by the West Midlands-Solihull National Health Service Research Ethics Committee (16/WM/0309) on 5 August 2016. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a local charity.
TRIAL REGISTRATION NUMBER


ISRCTN12923441.",2020,"The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect.","['cardiac surgery in children', '120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect', 'cyanotic and acyanotic young children', 'young children undergoing cardiac surgery']","['Bilateral Remote Ischaemic Conditioning', 'bilateral remote ischaemic preconditioning (3×5\u2009min cycles) or sham immediately prior to surgery']","['reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release', 'peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12\u2009hours, and lengths of stay in the paediatric intensive care unit and the hospital']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}, {'cui': 'C0185003', 'cui_str': 'Closure'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0332580', 'cui_str': 'Cyanotic'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",120.0,0.543449,"The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect.","[{'ForeName': 'Nigel E', 'Initials': 'NE', 'LastName': 'Drury', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK n.e.drury@bham.ac.uk.""}, {'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Bi', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stickley', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Montgomerie', 'Affiliation': ""Paediatric Cardiac Anaesthesia, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}, {'ForeName': 'Carin', 'Initials': 'C', 'LastName': 'van Doorn', 'Affiliation': 'Congenital Cardiac Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Warwick B', 'Initials': 'WB', 'LastName': 'Dunn', 'Affiliation': 'School of Biosciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Madhani', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, West Midlands, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Jones', 'Affiliation': ""Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.""}]",BMJ open,['10.1136/bmjopen-2020-042176']
2995,33033062,Does acupressure help reduce nausea and vomiting in palliative care patients? A double blind randomised controlled trial.,"INTRODUCTION


Nausea and vomiting are common symptoms for patients with advanced cancer. While there is evidence for acupuncture point stimulation for treatment of these symptoms for patients having anticancer treatment, there is little for when they are not related to such treatment.
OBJECTIVE


To determine whether acupressure at the pericardium 6 site can help in the treatment of nausea and vomiting suffered by palliative care patients with advanced cancer.
MATERIALS AND METHODS


Double blind randomised controlled trial-active versus placebo acupressure wristbands. In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached: Nausea that was at least moderate; Vomiting daily on average for the prior 3 days.
RESULTS


57 patients were randomised to have either active or placebo acupressure wristbands. There was no difference in any of the outcome measures between the two groups: change from baseline number of vomits; Visual Analogue Scale for 'did acupressure wristbands help you to feel better?'; total number of as needed doses of antiemetic medication; need for escalation of antiemetics.
CONCLUSIONS


In contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in-patients with advanced cancer and nausea and vomiting.",2020,"In contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in-patients with advanced cancer and nausea and vomiting.","['patients with advanced cancer', 'palliative care patients', 'patients with advanced cancer and nausea and vomiting', '57 patients', 'In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached', 'nausea and vomiting suffered by palliative care patients with advanced cancer']","['acupressure', 'placebo', 'placebo acupressure wristbands']","['Nausea and vomiting', 'nausea and vomiting', ""vomits; Visual Analogue Scale for 'did acupressure wristbands help you to feel better?'; total number of as needed doses of antiemetic medication; need for escalation of antiemetics"", 'Nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1445610', 'cui_str': 'Acupressure wrist band'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1445610', 'cui_str': 'Acupressure wrist band'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",57.0,0.714798,"In contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in-patients with advanced cancer and nausea and vomiting.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perkins', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, Gloucestershire, UK paul.perkins@suerydercare.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, Gloucestershire, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, Gloucestershire, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blaken', 'Affiliation': 'St Elizabeth Hospice, Ipswich, UK.'}, {'ForeName': 'Ralph K', 'Initials': 'RK', 'LastName': 'Akyea', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002434']
2996,33027531,Extended Perineural Analgesia After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine: Preliminary Report from a Randomized Clinical Trial.,"OBJECTIVE


We tested the hypothesis that buprenorphine-clonidine-dexamethasone (BCD) extends perineural analgesia compared with plain bupivacaine (BPV) nerve blocks used for hip and knee replacement surgery.
DESIGN


Prospective, parallel-arms, randomized, double-blind trial.
SETTING


A single veterans' hospital.
SUBJECTS


Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic.
METHODS


Participants underwent nerve/plexus blocks at L2-L4 and L4-S3 in advance of hip or knee joint replacement surgery. Patients were randomized to receive BPV-BCD or plain BPV in a 4:1 allocation ratio. Patients answered four block duration questions (listed below). Time differences between treatments were analyzed using the t test.
RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV (N = 16). The time until start of postoperative pain was 26 vs 11 hours (mean difference = 15 hours, 95% CI = 8 to 21). The time until no pain relief from the blocks was 32 vs 15 hours (mean difference = 17 hours, 95% CI = 10 to 24). The time until the numbness wore off was 37 vs 21 hours (mean difference = 16 hours, 95% CI = 8 to 23). The time until the worst postoperative pain was 39 vs 20 hours (mean difference = 19 hours, 95% CI = 11 to 27).
CONCLUSIONS


BPV-BCD provided 26-39 hours of perineural analgesia in the L2-L4 and L4-S3 nerve distributions after hip/knee replacement surgery, compared with 11-21 hours for plain BPV.",2020,"RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV","['Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic', 'Participants underwent', ""A single veterans' hospital""]","['Bupivacaine', 'Buprenorphine-Clonidine-Dexamethasone', 'Hip and Knee Replacement', 'plain BPV', 'BPV-BCD or plain BPV', 'Perineural Analgesia', 'nerve/plexus blocks at L2-L4 and L4-S3 in advance of hip or knee joint replacement surgery', 'buprenorphine-clonidine-dexamethasone (BCD', 'plain bupivacaine (BPV) nerve blocks']","['time until the numbness', 'time until no pain relief', 'time until start of postoperative pain', 'time until the worst postoperative pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020030', 'cui_str': 'Veterans Hospitals'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0584885', 'cui_str': 'Local anesthetic block of nerve plexus'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.215519,"RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Williams', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Ibinson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Ritter', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Ezaru', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hulimangala R', 'Initials': 'HR', 'LastName': 'Rakesh', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Paiste', 'Affiliation': 'Foundation for Anesthesia Education and Research (FAER), Schaumburg, Illinois.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Gilbert', 'Affiliation': 'Veterans Research Foundation of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Mikolic', 'Affiliation': 'StatCore, Veterans Research Foundation of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Visala S', 'Initials': 'VS', 'LastName': 'Muluk', 'Affiliation': 'Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Physical Therapy-Clinical Translational Research Center, Pittsburgh, Pennsylvania.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa229']
2997,33027534,The effect of advanced recovery room care on postoperative outcomes in moderate-risk surgical patients: a multicentre feasibility study.,"Postoperative complications are common and may be under-recognised. It has been suggested that enhanced postoperative care in the recovery room may reduce in-hospital complications in moderate- and high-risk surgical patients. We investigated the feasibility of providing advanced recovery room care for 12-18 h postoperatively in the post-anaesthesia care unit. The primary hypothesis was that a clinical trial of advanced recovery room care was feasible. The secondary hypothesis was that this model may have a sustained impact on postoperative in-hospital and post-discharge events. This was a multicentre, prospective, feasibility before-and-after trial of moderate-risk patients (predicted 30-day mortality of 1-4%) undergoing non-cardiac surgery and who were scheduled for postoperative ward care. Patients were managed using defined assessment checklists and goals of care in an advanced recovery room care setting in the immediate postoperative period. This utilised existing post-anaesthesia care unit infrastructure and staffing, but extended care until the morning of the first postoperative day. The advanced recovery room care trial was deemed feasible, as defined by the recruitment and per protocol management of > 120 patients. However, in a specialised cancer centre, recruitment was slow due to low rates of eligibility according to narrow inclusion criteria. At a rural site, advanced recovery room care could not be commenced due to logistical issues in establishing a new model of care. A definitive randomised controlled trial of advanced recovery room care appears feasible and, based on the indicative data on outcomes, we believe this is warranted.",2020,"However, in a specialised cancer centre, recruitment was slow due to low rates of eligibility according to narrow inclusion criteria.","['12-18\xa0h postoperatively in the post-anaesthesia care unit', 'moderate-risk surgical patients', 'moderate-risk patients (predicted 30-day mortality of 1-4%) undergoing non-cardiac surgery and who were scheduled for postoperative ward care', 'Patients were managed using defined assessment checklists and goals of care in an advanced recovery room care setting in the immediate postoperative period']",['advanced recovery room care'],['postoperative outcomes'],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",120.0,0.100817,"However, in a specialised cancer centre, recruitment was slow due to low rates of eligibility according to narrow inclusion criteria.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ludbrook', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maddern', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Department of Anaesthetics, Peri-operative and Pain Medicine, the Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Richardson', 'Affiliation': 'Department of Anaesthetics, Peri-operative and Pain Medicine, the Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'School of Medicine, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'Adelaide Health Technology Assessment, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'Adelaide Health Technology Assessment, University of Adelaide, Adelaide, Australia.'}]",Anaesthesia,['10.1111/anae.15260']
2998,33027546,Re: Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial.,,2020,,['acute pain in outpatient hysteroscopy'],[],[],"[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]",[],[],,0.271587,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mirza', 'Affiliation': 'Department of Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hanif', 'Affiliation': 'Department of Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jaleel', 'Affiliation': 'Department of Obstetrics and Gynaecology, George Elliot Hospital NHS, Nuneaton, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16500']
2999,33027550,Cardiometabolic effects of high-intensity hybrid functional electrical stimulation exercise after Spinal Cord Injury.,"INTRODUCTION


The prevalence of cardiometabolic disease following spinal cord injury is known to be high. However, it is unknown whether engaging in high-intensity exercise, which is advocated by recent guidelines, is beneficial or feasible for these individuals.
DESIGN


Combination of a randomized controlled trial and an open label intervention study of functional electrical stimulation legs plus arms rowing.
SETTING


Outpatient academic rehabilitation hospital.
PARTICIPANTS


Forty individuals with spinal cord injury, with ASIA impairments scales A-D and neurological levels of injury C1-T12.
INTERVENTION


Six months of high-intensity, hybrid functional electrical stimulation rowing.
MAIN OUTCOME MEASURES


Change in VO 2max  , prevalence of cardiometabolic disease, serum lipids, and insulin resistance.
RESULTS


Individuals averaged 42.1 ± 22.0 minutes of hybrid-functional electrical stimulation rowing a week over an average of 1.69 sessions per week over the 6 months of intervention. This amounted to an average of 170.9 ± 100 km rowed, at a mean heart rate of 82.7% of individualized maximum. Only one of 40 individuals met current exercise guidelines for the full 6 months. VO 2max  increased significantly (P < 0.001), yet prevalence of cardiometabolic disease did not significantly change (decrease from 22.5% to 20%, P = 0.70). A1C did significantly decrease over this time (P = 0.01), though serum lipids and fasting glucose/insulin levels were unchanged. In exploratory subanalyses assessing individuals injured less than or greater than 12 months, those with more chronic injuries decreased their triglyceride:HDL ratio (P = 0.04), a marker of cardiac mortality. Stratifying by neurological level of injury, individuals with paraplegia had worsened LDL (P = 0.02) and total cholesterol:HDL ratio (P = 0.04) over the six-month intervention.
CONCLUSIONS


Sustained high-intensity, exercise with hybrid functional electrical stimulation rowing does not decrease prevalence of cardiometabolic disease after spinal cord injury. This article is protected by copyright. All rights reserved.",2020,"VO 2max  increased significantly (P < 0.001), yet prevalence of cardiometabolic disease did not significantly change (decrease from 22.5% to 20%, P = 0.70).","['40 individuals met current exercise guidelines for the full 6\u2009months', 'Forty individuals with spinal cord injury, with ASIA impairments scales A-D and neurological levels of injury C1-T12', 'Spinal Cord Injury', 'Outpatient academic rehabilitation hospital']","['functional electrical stimulation legs plus arms rowing', 'hybrid functional electrical stimulation rowing', 'high-intensity hybrid functional electrical stimulation exercise']","['triglyceride:HDL ratio', 'Change in VO 2max  , prevalence of cardiometabolic disease, serum lipids, and insulin resistance', 'cardiac mortality', 'worsened LDL', 'prevalence of cardiometabolic disease', 'serum lipids and fasting glucose/insulin levels', 'total cholesterol:HDL ratio', 'VO 2max', 'cardiometabolic disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0054967', 'cui_str': 'Lymphocyte antigen CD6'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C2938855', 'cui_str': 'Total cholesterol:HDL ratio measurement'}]",40.0,0.0959669,"VO 2max  increased significantly (P < 0.001), yet prevalence of cardiometabolic disease did not significantly change (decrease from 22.5% to 20%, P = 0.70).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Spaulding Rehabilitation Hospital.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Mercier', 'Affiliation': 'Spaulding Rehabilitation Hospital.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Spaulding Rehabilitation Hospital.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12507']
3000,33027760,The Effect of Plantar Massage on Static Postural Control in Patients With Chronic Ankle Instability: A Critically Appraised Topic.,"Clinical Scenario: Patients with chronic ankle instability (CAI) demonstrate deficits in both sensory and motor function, which can be objectively evaluated through static postural control testing. One intervention that has been suggested to improve somatosensation and, in turn, static postural control is plantar massage. Clinical Question: Does plantar massage improve static postural control during single-limb stance in patients with CAI relative to baseline? Summary of Key Findings: A search was performed for articles exploring the effect of plantar massage on static postural control in individuals with CAI. Three articles were included in this critically appraised topic including 1 randomized controlled trial and 2 crossover studies. All studies supported the use of plantar massage to improve static postural control in patients with CAI. Clinical Bottom Line: There is currently good-quality and consistent evidence that supports the use of plantar massage as an intervention that targets the somatosensory system to improve static postural control in patients with CAI. Future research should focus on incorporating plantar massage as a treatment intervention during long-term rehabilitation protocols for individuals with CAI. Strength of Recommendation: In agreement with the Center of Evidence-Based Medicine, the consistent results from 2 crossover studies and 1 randomized controlled trial designate that there is level B evidence due to consistent, moderate- to high-quality evidence.",2020,Clinical Question: Does plantar massage improve static postural control during single-limb stance in patients with CAI relative to baseline?,"['patients with CAI relative to baseline', 'patients with CAI', 'individuals with CAI', 'Patients With Chronic Ankle Instability', 'Clinical Scenario: Patients with chronic ankle instability (CAI']","['plantar massage', 'Plantar Massage']","['static postural control', 'Static Postural Control', 'Strength of Recommendation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",3.0,0.0363614,Clinical Question: Does plantar massage improve static postural control during single-limb stance in patients with CAI relative to baseline?,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Helly', 'Affiliation': ''}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Bain', 'Affiliation': ''}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Gribble', 'Affiliation': ''}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Hoch', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2020-0092']
3001,33027765,Dry Needling for Hamstring Flexibility: A Single-Blind Randomized Controlled Trial.,"CONTEXT


Hamstring muscle tightness is one of the most common problems in athletic and healthy people. Dry needling (DN) was found to be an effective approach for improving muscle flexibility, but there is no study to compare this approach with static stretching (SS) as a common technique for the increase of muscle length.
OBJECTIVE


To compare the immediate effects of DN and SS on hamstring flexibility in healthy subjects with hamstring tightness.
STUDY DESIGN


A single-blind randomized controlled trial.
SETTING


A musculoskeletal physiotherapy clinic at Tehran University of Medical Sciences.
SUBJECTS


Forty healthy subjects (female: 32, age range: 18-40 y) with hamstring tightness were randomly assigned into 2 groups of DN and SS.
INTERVENTION


The DN group received a single session of DN on 3 points of the hamstring muscles, each for 1 minute. The SS group received a single session of SS of the hamstrings, consisting of 3 sets of 30-second SS with a 10-second rest between sets in the active knee extension test (AKET) position.
MAIN OUTCOME MEASURES


The AKET, muscle compliance, passive peak torque, and stretch tolerance were measured at the baseline, immediately, and 15 minutes after the interventions.
RESULTS


Improvements in all outcomes was better for the DN group than for the SS group. DN increased muscle compliance significantly 15 minutes after the intervention, but it did not improve in the SS group.
CONCLUSION


DN is effective in improving hamstring flexibility compared with SS. One session of DN can be an effective treatment for hamstring tightness and increase hamstring flexibility. The improvements suggest that DN is a novel treatment for hamstring flexibility.",2020,"RESULTS


Improvements in all outcomes was better for the DN group than for the SS group.","['A musculoskeletal physiotherapy clinic at Tehran University of Medical Sciences', 'Forty healthy subjects (female: 32, age range: 18-40\xa0y) with hamstring tightness', 'athletic and healthy people', 'Hamstring Flexibility', 'healthy subjects with hamstring tightness']","['DN and SS', 'Dry needling (DN', 'static stretching (SS', 'DN', 'Dry Needling']","['muscle compliance', 'muscle compliance, passive peak torque, and stretch tolerance', 'hamstring flexibility']","[{'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0461546,"RESULTS


Improvements in all outcomes was better for the DN group than for the SS group.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Alaei', 'Affiliation': ''}, {'ForeName': 'Noureddin', 'Initials': 'N', 'LastName': 'Nakhostin Ansari', 'Affiliation': ''}, {'ForeName': 'Soofia', 'Initials': 'S', 'LastName': 'Naghdi', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fakhari', 'Affiliation': ''}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Komesh', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dommerholt', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2020-0111']
3002,33027793,Pharmacoepidemiology of Furosemide in the Neonatal Intensive Care Unit.,"BACKGROUND


Furosemide is commonly used off-label in the neonatal intensive care unit (NICU), but current dosing practices vary widely.
OBJECTIVES


To describe dosing practices including route, dose, and duration of exposure to furosemide in a large number of community and tertiary NICUs across North America.
METHOD


Using the Pediatrix Medical Group Clinical Data Warehouse, we identified infants who received ≥1 dose of furosemide between 1997 and 2016. We excluded infants with incomplete dosing data. We calculated average daily furosemide dose, cumulative dose, total days of exposure, and maximum daily dose. We compared dosing between infants born at <32 weeks gestational age (GA) and ≥32 weeks GA.
RESULTS


A total of 18,572 infants had complete dosing data. The median (interquartile value) postnatal age at first exposure was 11 days (4, 26), the median maximum daily dose was 1.0 mg/kg (0.97, 1.6), the median average daily dose was 1.0 mg/kg (0.88, 1.1), and the median cumulative dose was 2.0 mg/kg (1.0, 4.5). The median total duration of exposure was 2 days (1, 4). A total of 177 (1%) infants received ≥4 mg/kg/day of furosemide. Infants born <32 weeks GA were an older age at initial furosemide exposure compared to those born ≥32 weeks GA: 19 versus 4 days, p < 0.001.
CONCLUSIONS


Most infants received short courses of furosemide within the labeled dosing parameters. Further studies are needed to assess the safety and efficacy of furosemide in the NICU.",2020,"Infants born <32 weeks GA were an older age at initial furosemide exposure compared to those born ≥32 weeks GA: 19 versus 4 days, p < 0.001.
","['infants born at <32 weeks gestational age (GA) and ≥32 weeks GA', '18,572 infants had complete dosing data']","['Furosemide', 'furosemide']","['median total duration of exposure', 'safety and efficacy']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",18572.0,0.147741,"Infants born <32 weeks GA were an older age at initial furosemide exposure compared to those born ≥32 weeks GA: 19 versus 4 days, p < 0.001.
","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Thompson', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Department of Economics, Clemson University, Clemson, South Carolina, USA.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Greenberg', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Karan R', 'Initials': 'KR', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kanecia O', 'Initials': 'KO', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Laughon', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, UNC Hospital, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Reese H', 'Initials': 'RH', 'LastName': 'Clark', 'Affiliation': 'The Pediatrix-Obstetrix Center for Research, Education, and Quality, Sunrise, Florida, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA, christoph.hornik@duke.edu.'}]",Neonatology,['10.1159/000510657']
3003,33027799,Heterogeneity of Effect of Net Ultrafiltration Rate among Critically Ill Adults Receiving Continuous Renal Replacement Therapy.,"INTRODUCTION


In continuous renal replacement therapy (CRRT)-treated patients, a net ultrafiltration (NUF) rate >1.75 mL/kg/h has been associated with increased mortality. However, there may be heterogeneity of effect of NUF rate on mortality, according to patient characteristics.
METHODS


To investigate the presence and impact of heterogeneity of effect, we performed a secondary analysis of the ""Randomized Evaluation of Normal versus Augmented Level of Renal Replacement Therapy"" (RENAL) trial. Exposure was NUF rate (weight-adjusted fluid volume removed per hour) stratified into tertiles (<1.01 mL/kg/h; 1.01-1.75 mL/kg/h; or >1.75 mL/kg/h). Primary outcome was 90-day mortality. Patients were clustered according to baseline characteristics. Heterogeneity of effect was assessed according to clusters and baseline edema and related to the additional impact of baseline cardiovascular Sequential Organ Failure Assessment (SOFA) score. We excluded patients with missing values for baseline weight and/or treatment duration.
RESULTS


We identified 2 clusters. The largest (cluster 1; n = 941) included more severely ill patients, with more sepsis, more edema, and more vasopressor therapy (all p < 0.001). Compared to the middle tertile, the probability of harm was greater with the high tertile of NUF rate in patients in cluster 1 and in patients with baseline edema (probability of harm, cluster 1: 99.9%; edema: 99.1%). Moreover, higher baseline cardiovascular SOFA score also increased mortality risk with both high and low compared to middle NUF rates in cluster 1 patients and in patients with edema.
CONCLUSIONS


In CRRT patients, both high and low NUF rates may be harmful, especially in those with edema, sepsis, and greater illness severity. Cardiovascular SOFA scores modulate this association. Additional studies are needed to test these hypotheses, and targeted trials of NUF rates based on risk stratification appear justified.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00221013.",2020,"Compared to the middle tertile, the probability of harm was greater with the high tertile of NUF rate in patients in cluster 1 and in patients with baseline edema (probability of harm, cluster 1: 99.9%; edema: 99.1%).","['patients with missing values for baseline weight and/or treatment duration', 'Critically Ill Adults Receiving Continuous Renal Replacement Therapy']","['Normal versus Augmented Level of Renal Replacement Therapy"" (RENAL']","['mortality risk', 'higher baseline cardiovascular SOFA score', 'middle NUF rates', 'NUF rate (weight-adjusted fluid volume', 'Cardiovascular SOFA scores', 'probability of harm', 'baseline cardiovascular Sequential Organ Failure Assessment (SOFA) score', 'NUF rate', 'mortality', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",941.0,0.308373,"Compared to the middle tertile, the probability of harm was greater with the high tertile of NUF rate in patients in cluster 1 and in patients with baseline edema (probability of harm, cluster 1: 99.9%; edema: 99.1%).","[{'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia, thummaporn.naorungroj@austin.org.au.'}, {'ForeName': 'Raghavan', 'Initials': 'R', 'LastName': 'Murugan', 'Affiliation': 'Department of Critical Care Medicine, The Center for Critical Care Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Department of Critical Care Medicine, The Center for Critical Care Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'Department of Nephrology, The George Institute for Global Health and University of Sydney, Sidney, New South Wales, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}]",Blood purification,['10.1159/000510556']
3004,33027800,Effectiveness of Medical Nutrition Therapy to Improve Dietary Habits for Promoting Bone Health in People Living with Chronic HIV.,"INTRODUCTION


Previous studies have established the risk of bone loss among people living with HIV affected by antiretroviral therapy drug side effects and inadequate nutrient intake. Until recently, there have been limits on using the medical nutrition therapy (MNT) to improve dietary habits for promoting bone health among people living with HIV. This was a randomized controlled trial study aimed to investigate the effectiveness of MNT in improving the bone health in people living with HIV by promoting dietary habits.
METHODS


PLHIV at Queen Savang Vadhana Memorial Hospital were randomly grouped (by quota sampling) into the MNT group (intervention group) and the control group. One hundred and thirty PLHIV were recruited to participate in this study by convenient sampling. Sixty-five participants of the MNT group made a total of 6 appointments (for 12 weeks) to meet registered dietitians for receiving MNT to improve dietary habits for improving bone health, while 65 participants in the control group received only routine care at the hospital service center.
RESULTS


In general, participants in the MNT group had significant increase in the amounts of calcium, vitamin D, potassium, and phosphorus intakes and length of exercise after the final week compared with before intervention. Also, they had significantly higher amount of nutrient intakes (calcium, vitamin D, potassium, and phosphorus) and length of exercise than the control group after finishing the final week of the experiment.
CONCLUSION


In conclusion, MNT is effective for improving food habits and physical activity to promote bone health among people living with HIV.",2020,"In general, participants in the MNT group had significant increase in the amounts of calcium, vitamin D, potassium, and phosphorus intakes and length of exercise after the final week compared with before intervention.","['PLHIV at Queen Savang Vadhana Memorial Hospital', 'people living with HIV by promoting dietary habits', 'Sixty-five participants of the MNT group made a total of 6 appointments (for 12 weeks) to meet registered dietitians for receiving MNT to improve dietary habits for improving bone health, while 65 participants in the control group received only routine care at the hospital service center', 'People Living with Chronic HIV', 'One hundred and thirty PLHIV', 'people living with HIV']","['medical nutrition therapy (MNT', 'MNT', 'MNT group (intervention group) and the control group', 'Medical Nutrition Therapy']","['bone health', 'amounts of calcium, vitamin D, potassium, and phosphorus intakes and length of exercise', 'nutrient intakes (calcium, vitamin D, potassium, and phosphorus) and length of exercise']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0559872', 'cui_str': 'Phosphorus intake'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",130.0,0.0575021,"In general, participants in the MNT group had significant increase in the amounts of calcium, vitamin D, potassium, and phosphorus intakes and length of exercise after the final week compared with before intervention.","[{'ForeName': 'Alongkote', 'Initials': 'A', 'LastName': 'Singhato', 'Affiliation': 'Nutritional Therapy and Dietetics division, Faculty of Allied Health Sciences, Burapha University, Chonburi, Thailand.'}, {'ForeName': 'Somjet', 'Initials': 'S', 'LastName': 'Khongkhon', 'Affiliation': 'Thai Traditional Medicine division, Faculty of Thai Traditional and Alternative Medicine, Ubon Ratchathani Rajabhat University, Ubon Ratchathani, Thailand.'}, {'ForeName': 'Narisa', 'Initials': 'N', 'LastName': 'Rueangsri', 'Affiliation': 'Nutritional Therapy and Dietetics division, Faculty of Allied Health Sciences, Burapha University, Chonburi, Thailand.'}, {'ForeName': 'Uraiporn', 'Initials': 'U', 'LastName': 'Booranasuksakul', 'Affiliation': 'Nutritional Therapy and Dietetics division, Faculty of Allied Health Sciences, Burapha University, Chonburi, Thailand, uraipornbrnssk@gmail.com.'}]",Annals of nutrition & metabolism,['10.1159/000510367']
3005,33027827,[Regional Influences on Home Visits - Is Care in Rural Areas Secured in the Long Term?],"BACKGROUND


Demographic change and urbanisation are proceeding at a rapid pace in Germany. Although the need for care is increasing due to a growing older and multimorbid generation, the number of home visits by general practitioners has been declining since years. Previous studies have shown that the workload for general practitioners is increasing, especially in rural areas.  Research question  What kind of structural practice characteristics are associated with the frequency of GP home visits? What influence do regional characteristics of GP practices have?
METHODS


In a study of family doctors̓ practices in Saxony, 4286 home visits were documented by questionnaires from 303 participating practices over a period of one year. Each practice surveyed the home visits within a randomly assigned week. In addition to the characteristics of the home visits, information about the practice, such as regional location, home visit organization and patient numbers was also collected. The frequency of home visits was based on information provided by the doctors surveyed. Subsequently, the data based on the postal code were supplemented with structural information from the State Statistical Office and data from the Association of Statutory Health Insurance Physicians (Kassenärztliche Vereinigung-KV). The data were first analysed regarding bivariate associations. Significantly associated variables were finally tested in a multivariate regression model.
RESULTS


According to their own statements, the interviewed general practitioners carried out an average of 14.5 (SD 9.5) home visits per week, which included the care of 32.0 (SD 30.0) nursing home patients. The number of home visits correlated significantly negatively with the number of inhabitants and significantly positively with the average age of the region. In the multivariate analysis, the age of the doctor was found to be the largest predictor of the number of home visits per week, with younger doctors making significantly fewer home visits.
CONCLUSION


The number of home visits per week continues to decline compared to preliminary studies. In the regression model, the great influence of the doctor̓s age on the number of home visits is striking. While regional-structural characteristics fade into the background, a changed attitude towards home visits must be assumed, with telemedicine and delegation coming to the fore.",2020,The number of home visits correlated significantly negatively with the number of inhabitants and significantly positively with the average age of the region.,"['family doctors̓ practices in Saxony, 4286 home visits were documented by questionnaires from 303 participating practices over a period of one year', 'interviewed general practitioners carried out an average of 14.5 (SD 9.5) home visits per week, which included the care of 32.0 (SD 30.0) nursing home patients']",[],['number of home visits'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]",,0.0276451,The number of home visits correlated significantly negatively with the number of inhabitants and significantly positively with the average age of the region.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenz', 'Affiliation': ''}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Schübel', 'Affiliation': ''}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Voigt', 'Affiliation': ''}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-1241-4107']
3006,33027941,Randomized Longitudinal Study Comparing Three Nasal Respiratory Support Modes to Prevent Intermittent Hypoxia in Very Preterm Infants.,"Nasal continuous positive airway pressure (NCPAP) devices using variable (vf-) and continuous (cf-) flow or synchronized nasal intermittent positive pressure ventilation (s-NIPPV) are used to prevent or treat intermittent hypoxia (IH) in preterm infants. Results concerning which is most effective vary. We aimed to investigate the effect of s-NIPPV and vf-NCPAP compared to cf-NCPAP on the rate of IH episodes. Preterm infants with a gestational age of 24.9-29.7 weeks presenting with IH while being treated with cf-NCPAP were monitored for eight hours, then randomized to eight hours of treatment with vf-NCPAP or s-NIPPV. Data from 16 infants were analyzed. Due to an unexpectedly low sample size, the results were only reported descriptively. No relevant changes in the rate of IH events were detected between cf- vs. vf-NCPAP or between cf-NCPAP vs. s-NIPPV. Although limited by its small sample size, s-NIPPV, vf- and cf-NCPAP seemed to be similarly effective in the treatment of IH in these infants.",2020,No relevant changes in the rate of IH events were detected between cf- vs. vf-NCPAP or between cf-NCPAP vs. s-NIPPV.,"['preterm infants', 'Very Preterm Infants', '16 infants were analyzed', 'Preterm infants with a gestational age of 24.9-29.7 weeks presenting with IH while being treated with']","['vf-NCPAP or s-NIPPV', 'cf-NCPAP', 's-NIPPV and vf-NCPAP compared to cf-NCPAP', 'Nasal continuous positive airway pressure (NCPAP) devices using variable (vf-) and continuous (cf-) flow or synchronized nasal intermittent positive pressure ventilation (s-NIPPV']","['rate of IH events', 'rate of IH episodes']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",16.0,0.0564144,No relevant changes in the rate of IH events were detected between cf- vs. vf-NCPAP or between cf-NCPAP vs. s-NIPPV.,"[{'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Gross', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, 72076 Tübingen, Germany.""}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, 72076 Tübingen, Germany.""}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Steinfeldt', 'Affiliation': 'Department of Pediatrics, Klinikum Neukölln, 12351 Berlin, Germany.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Urschitz', 'Affiliation': 'Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology, and Informatics, University Medical Centre of the Johannes Gutenberg University Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Böckmann', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, 72076 Tübingen, Germany.""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Haase', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, 72076 Tübingen, Germany.""}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, 72076 Tübingen, Germany.""}]","Children (Basel, Switzerland)",['10.3390/children7100168']
3007,33027942,Polyphenol Bioavailability and Plasma Antiradical Capacity in Healthy Subjects after Acute Intake of Pigmented Rice: A Crossover Randomized Controlled Clinical Trial.,"Health-promoting effects of plant foods have been emphasized in the last few decades and ascribed to the bioactive phytochemicals present therein-in particular, phenylpropanoids. The latter have been investigated for a number of preclinical biological activities, including their antioxidant power. Due to the paucity of human studies, in this randomized intervention trial, we investigated whether the acute intake of pigmented rice could increase the plasma bioactive levels and antiradical power in twenty healthy subjects. A crossover randomized controlled clinical trial was conducted on 19 volunteers. Artemide and Venere black rice cultivars were tested, while brown rice Carnaroli was used as a control. Each patient received randomly one serving (100 g) of rice on three different experimental days, separated by a 7-day washout period. After baseline blood withdrawal, time-course changes of plasma polyphenols, flavonoids and radical-scavenging capacity were determined at 30, 60, 120 and 180 min post rice intake. Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption. Pigmented rice consumption can contribute to diet-related health benefits in humans.",2020,"Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption.","['humans', '19 volunteers', 'Healthy Subjects after Acute Intake of Pigmented Rice', 'twenty healthy subjects']",[],"['plasma levels of polyphenols and flavonoids', 'plasma bioactive levels and antiradical power', 'plasma antiradical power', 'plasma polyphenols, flavonoids and radical-scavenging capacity', 'Polyphenol Bioavailability and Plasma Antiradical Capacity']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035567', 'cui_str': 'Rice'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",19.0,0.0232442,"Compared to Carnaroli rice, the two black rice cultivars significantly increased the plasma levels of polyphenols and flavonoids at 60 and 120 min and, correspondingly, the plasma antiradical power at 60 min after consumption.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vitalini', 'Affiliation': 'Department of Agricultural and Environmental Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sardella', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fracassetti', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Secli', 'Affiliation': 'ASST Santi Paolo e Carlo-Presidio Ospedaliero San Paolo-Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tirelli', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lodi', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carrassi', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Elena Maria', 'Initials': 'EM', 'LastName': 'Varoni', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, 20142 Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Iriti', 'Affiliation': 'Department of Agricultural and Environmental Sciences, Università degli Studi di Milano, 20133 Milan, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9103209']
3008,33027966,Improvement of Dietary Diversity and Attitude toward Recommended Feeding through Novel Community Based Nutritional Education Program in Coastal Kenya-An Intervention Study.,"Community-based nutritional intervention to improve the practice of dietary diversity and child nutrition by community health workers (CHWs) involving Nyumba Kumi as small neighborhood units (SNUs) in communities has not yet been explored. This study was conducted in two villages in rural Kenya between 2018 and 2019. In total, 662 participants (control vs. intervention:  n  = 339 vs.  n  = 323) were recruited. The intervention group received education on maternal and child nutrition and follow-up consultations. The custom-tailored educational guidelines were made based on Infant and Young Child Feeding and the mother and child health booklet. The educational effects on household caregivers' feeding practice attitude and child nutritional status were analyzed using multiple linear regression. After the intervention, a total of 368 household caregivers (187 vs. 181) and 180 children (113 vs. 67) were analyzed separately. Between the groups, no significant difference was found in their background characteristics. This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01). The results revealed that the interventions using CHWs and SNUs were useful to improve dietary diversity and caregivers' attitudes toward recommended feeding. This research has the potential to be successfully applied in other regions where child undernutrition remains.",2020,This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01).,"['368 household caregivers (187 vs. 181) and 180 children (113 vs. 67) were analyzed separately', '662 participants (control vs. intervention:  n  = 339 vs.  n  = 323) were recruited', 'two villages in rural Kenya between 2018 and 2019']","['education on maternal and child nutrition and follow-up consultations', 'Community-based nutritional intervention']","[""dietary diversity and caregivers' attitudes"", 'dietary diversity score', 'attitude score']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",662.0,0.0152083,This study successfully improved the dietary diversity score (β = 0.54;  p  < 0.01) and attitude score (β = 0.29;  p  < 0.01).,"[{'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Hitachi', 'Affiliation': 'Program for Nurturing Global Leaders in Tropical and Emerging Communicable Diseases, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Wanjihia', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Nyandieka', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Chepkirui', 'Initials': 'C', 'LastName': 'Francesca', 'Affiliation': 'Department of Community Health and Epidemiology, School of Public Health, Kenyatta University, Nairobi 43844-00100, Kenya.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Wekesa', 'Affiliation': 'Kenya Medical Research Institute, KEMRI graduate school, Nairobi 54840-00200, Kenya.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Changoma', 'Affiliation': 'NUITM-KEMRI Project, Institute of Tropical Medicine (NUITM), Nagasaki University, Nairobi 19993-00202, Kenya.'}, {'ForeName': 'Erastus', 'Initials': 'E', 'LastName': 'Muniu', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Ndemwa', 'Affiliation': 'Centre for Public Health Research, Kenya Medical Research Institute (KEMRI), Nairobi 20752-00202, Kenya.'}, {'ForeName': 'Sumihisa', 'Initials': 'S', 'LastName': 'Honda', 'Affiliation': 'Department of Nursing, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hirayama', 'Affiliation': 'Department of Immunogenetics, Institute of Tropical Medicine, Nagasaki University, Nagasaki 852-8523, Japan.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Karama', 'Affiliation': 'Kenya Medical Research Institute, KEMRI graduate school, Nairobi 54840-00200, Kenya.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Eco-epidemiology, Institute of Tropical Medicine, Nagasaki University, Nagasaki 852-8523, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17197269']
3009,33028030,Narrative Voice Matters! Improving Smoking Prevention with Testimonial Messages through Identification and Cognitive Processes.,"Narrative messages are increasingly being used in the field of tobacco prevention. Our study is based on narrative persuasion and aims to analyze the psychological mechanisms that explain why the narrative voice is relevant to promote persuasive impact. An online experiment with a 2 (narrative voice) × 2 (message) factorial design was carried out. Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message). To increase the external validity of the study, two different messages were used within each condition. After reading the narrative message the mediating and dependent variables were evaluated. Participants who read the narrative in the first person experienced greater identification. Moreover, mediational analysis showed that both counterarguing and cognitive elaboration played a significant role in the relationship between narrative voice, identification, and persuasive impact. This study confirm that narrative voice is not only an anecdotal formal choice but that it indirectly affects variables related to tobacco prevention, due to the fact that first-person messages activate a mechanism of affective connection with the message (increasing the identification with the protagonist) that decreases resistance to prevention (the counterarguing process) while simultaneously stimulating reflection or cognitive elaboration.",2020,Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message).,['Participants (525 adult smokers'],[],['external validity'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",525.0,0.0168639,Participants (525 adult smokers) were randomly assigned to two experimental conditions (first-person versus third-person narrative message).,"[{'ForeName': 'Juan-José', 'Initials': 'JJ', 'LastName': 'Igartua', 'Affiliation': 'Department of Sociology and Communication, Faculty of Social Sciences, Campus Unamuno (Edificio FES), 37007 Salamanca, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rodríguez-Contreras', 'Affiliation': 'Department of Sociology and Communication, Faculty of Social Sciences, Campus Unamuno (Edificio FES), 37007 Salamanca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17197281']
3010,33028054,Comparison of Subgingival Irrigation Effect of Boric Acid 0.5% and Povidone-Iodine 0.1% on Chronic Periodontitis Treatment.,"PURPOSE


To comparatively evaluate the effect of a 5% boric acid (BA) irrigant on periodontal condition, bacterial level and oral neutrophil numbers with a 1% povidone iodine (PVP-I) irrigant as an adjunct to scaling and root planing (SRP) in chronic periodontitis (CP) treatment.
MATERIALS AND METHODS


A single-masked, randomised clinical trial with 36 CP patients was conducted at the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam. Subjects were randomly divided into two treatment groups: 1) SRP plus PVP-I 0.1% irrigant and 2) SRP plus BA 0.5% irrigant. Clinical measurements, including the plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), bacterial level in subgingival plaque (BANA test) and the quantification of oral neutrophils were evaluated at baseline, 4, 6 and 8 weeks after treatment (T0, T4, T6 and T8).
RESULTS


Whole-mouth (PI, GI, BOP, PD, CAL and PD) parameters, bacterial level in subgingival plaque and number of oral neutrophils decreased statistically significantly after treatment compared to baseline in both groups (p < 0.01). Between the two groups, whole-mouth PI, GI, BOP, PD and CAL reduction in the BA 0.5% group were higher than those in the PVP-I 0.1% group, but statistical significance was found only for GI and BOP after treatment (p < 0.05). The PD and CAL reductions for moderately deep pockets (PD ≥ 5 mm and < 7 mm) were significantly greater in group 2 compared to group 1 after treatment compared to baseline (p < 0.01). This difference was not found for deep pockets (PD ≥ 7 mm).
CONCLUSION


The results of this study suggest that BA 0.5% could be an alternative to PVP-I 0.1%, and might be more favourable because it provided superior results regarding whole-mouth BOP, GI as well as PD and CAL reduction for moderately deep pockets after CP treatment.",2020,The PD and CAL reductions for moderately deep pockets (PD ≥ 5 mm and < 7 mm) were significantly greater in group 2 compared to group 1 after treatment compared to baseline (p < 0.01).,"['chronic periodontitis (CP) treatment', 'Chronic Periodontitis\ufeff Treatment', '36 CP patients was conducted at the Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam']","['SRP plus PVP-I 0.1% irrigant and 2) SRP plus BA 0.5% irrigant', 'Boric Acid 0.5% and Povidone-Iodine', 'povidone iodine (PVP-I) irrigant', '5% boric acid (BA) irrigant']","['PD and CAL reductions', 'plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), bacterial level in subgingival plaque (BANA test) and the quantification of oral neutrophils', 'periodontal condition, bacterial level and oral neutrophil numbers', 'whole-mouth PI, GI, BOP, PD and CAL reduction', 'Whole-mouth (PI, GI, BOP, PD, CAL and PD) parameters, bacterial level in subgingival plaque and number of oral neutrophils', 'GI and BOP']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0006020', 'cui_str': 'boric acid'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",36.0,0.0657455,The PD and CAL reductions for moderately deep pockets (PD ≥ 5 mm and < 7 mm) were significantly greater in group 2 compared to group 1 after treatment compared to baseline (p < 0.01).,"[{'ForeName': 'Thuy Anh Vu', 'Initials': 'TAV', 'LastName': 'Pham', 'Affiliation': ''}, {'ForeName': 'Nhat Dinh', 'Initials': 'ND', 'LastName': 'Phan', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45356']
3011,33028064,Long-term benefits of chest compression-only cardiopulmonary resuscitation training using real-time visual feedback manikins: a randomized simulation study.,"OBJECTIVE


Cardiopulmonary resuscitation (CPR) education with a feedback device is known to result in better CPR skills compared to one without the feedback device. However, its long-term benefits have not been established. The purpose of this study was to evaluate the long-term CPR skill retention after training using real-time visual manikins in comparison to that of non-feedback manikins.
METHODS


We recruited 120 general university students who were randomly divided into the real-time feedback group (RTFG) and the non-feedback group. Of them, 95 (RTFG, 48; non-feedback group, 47) attended basic life support and automated external defibrillation training for 1 hour. For comparison of retention of CPR skills, the two groups were evaluated based on 2-minute chest compression performed immediately after training and at 3, 6, and 9 months. The CPR parameters between the two groups were also compared using a generalized linear model.
RESULTS


At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001). This significant difference was maintained until 6 months after training, but there was no difference at 9 months after training. However, there was no significant difference in the chest compression rate and the correct hand position at any time point.
CONCLUSION


CPR training with a real-time visual feedback manikin improved skill acquisition in chest compression depth, but only until 6 months after the training. It could be a more effective educational method for basic life support training in laypersons.",2020,"At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001).",['120 general university students who were randomly divided into the'],"['real-time feedback group (RTFG) and the non-feedback group', 'CPR training with a real-time visual feedback manikin', 'chest compression-only cardiopulmonary resuscitation training']","['chest compression rate', 'CPR parameters', 'adequate chest compression depth', 'average chest compression depth']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",120.0,0.0304546,"At immediately after training, the performance of RTFG was better in terms of average chest compression depth (51.9±1.1 vs. 45.5±1.1, p<0.001) and a higher percentage of adequate chest compression depth (51.0±4.1 vs. 26.9±4.2, p<0.001).","[{'ForeName': 'Tae Chang', 'Initials': 'TC', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Sungbae', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Ahn', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Eun', 'Initials': 'DE', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Won Kee', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Informatics, Kyungpook National University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Sang Gyu', 'Initials': 'SG', 'LastName': 'Kwak', 'Affiliation': 'Department of Medical Statistics, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Yeungnam University College of Medicine, Daegu, Korea.'}]",Clinical and experimental emergency medicine,['10.15441/ceem.20.022']
3012,33028082,"Left Ventricular Enlargement, CRT Response and Impact of MultiPoint Pacing.","Background  - Left ventricular (LV) epicardial pacing results in slowly propagating paced wavefronts. We postulated that this effect might limit cardiac resynchronization therapy (CRT) efficacy in patients with LV enlargement using conventional biventricular (BiV) pacing with single-site LV pacing, but be mitigated by LV stimulation from 2 widely spaced sites using MultiPoint™ Pacing (MPP-AS: anatomical separation ≥ 30mm). We tested this hypothesis in the multicenter randomized MPP IDE trial.  Methods  - Following implant, quadripolar BiV pacing was activated in all patients (n=506). From 3 to 9 months postimplant, among patients with available baseline LV end-diastolic volume (LVEDV) measures, 188 received BiV pacing, and 43 received MPP-AS. Patients were dichotomized by median baseline LVEDV indexed to height (LVEDVI Median ). Outcomes were measured by the clinical composite score (CCS, primary efficacy endpoint), quality of life (QOL), LV structural remodeling (↑EF>5% and ↓ESV 10%) and heart failure (HF) event/ cardiovascular death.  Results  - LVEDVI Median  was 1.1 mL/cm. Baseline characteristics differed in patients with LVEDVI >Median  vs. LVEDVI ≤Median . Among patients with LVEDVI >Median , BiV was less efficacious compared to patients with LVEDVI ≤Median  (CCS 65% vs. 79%). In contrast, MPP-AS programming generated greater CCS response (92% vs. 65%, p=0.023) and improved QOL (-31.0±29.7 vs. -15.7±22.1, p=0.038) vs. BiV in patients with LVEDVI >Median . Reverse remodeling trended better with MPP-AS programming. When LVEDVI >Median , HF event rate increased following the 3-month randomization point (0.0150±0.1725 in LVEDVI >Median  vs. -0.0190±0.0808 in LVEDVI ≤Median , p=0.012) in BiV, but no heart failure event occurred in patients with MPP-AS programming between 3 and 9 months in LVEDVI >Median . All measured outcomes did not differ in patients receiving MPP-AS and BiV pacing with LVEDVI ≤Median .  Conclusions  - Conventional BiV pacing, even with a quadripolar lead, has reduced efficacy in patients with LV enlargement. However, in patients with larger hearts and programmed to MPP-AS the greatest response rate was observed.",2020,"In contrast, MPP-AS programming generated greater CCS response (92% vs. 65%, p=0.023) and improved QOL (-31.0±29.7 vs. -15.7±22.1, p=0.038) vs. BiV in patients with LVEDVI >Median .","['patients with LV enlargement using', 'patients with LV enlargement']","['  - Left ventricular (LV) epicardial pacing', 'Methods  - Following implant, quadripolar BiV pacing', 'limit cardiac resynchronization therapy (CRT', 'conventional biventricular (BiV) pacing with single-site LV pacing']","['LVEDVI >Median , HF event rate', 'clinical composite score (CCS, primary efficacy endpoint), quality of life (QOL), LV structural remodeling (↑EF>5% and ↓ESV 10%) and heart failure (HF) event/ cardiovascular death', 'Left Ventricular Enlargement, CRT Response and Impact of MultiPoint Pacing', 'QOL', 'CCS response', 'response rate', 'heart failure event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0397434', 'cui_str': 'Insertion of epicardial electrode for temporary cardiac pacing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0079031', 'cui_str': 'Bovine immunodeficiency virus'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]",,0.0515493,"In contrast, MPP-AS programming generated greater CCS response (92% vs. 65%, p=0.023) and improved QOL (-31.0±29.7 vs. -15.7±22.1, p=0.038) vs. BiV in patients with LVEDVI >Median .","[{'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker Ii', 'Affiliation': 'Saint Thomas Research Institute, Nashville, TN.'}, {'ForeName': 'Gery', 'Initials': 'G', 'LastName': 'Tomassoni', 'Affiliation': 'Baptist Health Lexington, Lexington, KY.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Love', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': ""Brigham and Women's Hospital, Boston MA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sheppard', 'Affiliation': 'The Heart Institute, St. Petersburg, FL.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Niazi', 'Affiliation': 'Aurora Cardiovascular Services, Milwaukee, WI.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cranke', 'Affiliation': 'Abbott, Plano, TX.'}, {'ForeName': 'Kwangdeok', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Abbott, Plano, TX.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Corbisiero', 'Affiliation': 'Deborah Heart and Lung, Browns Mills, NJ.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008680']
3013,33028084,Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting.,"Aim:  To examine the prognostic value of the platelet-to-lymphocyte ratio (PLR) in the adjuvant renal cell carcinoma setting.  Materials & methods:  Patients received adjuvant sunitinib (50 mg/day; 4 weeks on/2 weeks off) or placebo. The primary end point was disease-free survival (DFS).  Results:  In 609 patients, DFS was similar for baseline PLR <140 versus ≥140 overall (median: 6.4 vs 5.9 years; hazard ratio: 0.9; 95% CI: 0.7-1.2). A ≥25% decrease in PLR at week 4 overall was associated with longer DFS versus no change (hazard ratio: 0.8; 95% CI: 0.6-1.0).  Conclusion:  Baseline PLR was not prognostic for DFS with adjuvant sunitinib treatment in patients with renal cell carcinoma. Clinical Trials Registration: NCT00375674 (ClinicalTrials.gov).",2020,A ≥25% decrease in PLR at week 4 overall was associated with longer DFS versus no change (hazard ratio: 0.8; 95% CI: 0.6-1.0).  ,"['patients with renal cell carcinoma', '609 patients, DFS was similar for baseline PLR']","['adjuvant sunitinib', 'placebo', 'platelet-to-lymphocyte ratio (PLR']","['disease-free survival (DFS', 'PLR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",609.0,0.39097,A ≥25% decrease in PLR at week 4 overall was associated with longer DFS versus no change (hazard ratio: 0.8; 95% CI: 0.6-1.0).  ,"[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Private Residence, London, UK.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, 33000 Bordeaux, France.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': 'UCLA David Geffen School of Medicine, Los Angeles, CA 90094, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'University Hospital of Munich, 80336 Munich, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, 94800 Villejuif, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc., La Jolla, CA 92121, USA.'}, {'ForeName': 'Mariajose', 'Initials': 'M', 'LastName': 'Lechuga', 'Affiliation': 'Pfizer S.r.L, Via Anna Maria Mozzoni, 12, 20152 Milan, Italy.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc., La Jolla, CA 92121, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke Cancer Institute, Durham, NC 27710, USA.'}]","Future oncology (London, England)",['10.2217/fon-2020-0652']
3014,33033657,"Effect of risk messages on risk appraisals, attitudes, ambivalence, and willingness to smoke hookah in young adults.","Objective


We examined effects of hookah tobacco risk messages on risk appraisals, attitudes towards hookah, ambivalence about hookah use, and willingness to smoke in young adults aged 18-30 years ( n  = 234).
Design


In an online experiment, participants completed preexposure measures and were randomized to hookah tobacco risk messages or to a no message control condition.
Main Outcome Measures


Risk appraisals, attitudes, ambivalence, and willingness to smoke hookah.
Results


Those who viewed risk messages reported greater risk appraisals (M 4.50, SD 1.17 vs. M 3.87, SD 1.16,  p  < .001), less positive attitudes (M -0.56, SD 1.24, vs. M 0.39, SD 1.35,  p  < .001), greater ambivalence (M 3.86, SD 1.26, vs. M 3.08, SD 1.32,  p  < .001), and less willingness to smoke than controls (M 4.48, SD 1.27, vs. M 4.85, SD 1.37,  p  = .034). Structural equation modeling demonstrated messages reduced willingness to smoke by evoking less positive attitudes ( b  = -0.15, 95% CI -0.32, -0.05) and by the effect of heightened risk appraisals on less positive attitudes ( b  = -0.14, 95% CI -0.30, -0.07).
Conclusions


Honing messages and understanding their mechanisms of action are necessary to produce more effective interventions to address hookah and other tobacco use in young adults.",2020,"Those who viewed risk messages reported greater risk appraisals (M 4.50, SD 1.17 vs. M 3.87, SD 1.16,  ","['young adults', 'young adults aged 18-30 years ( n  = 234']","['hookah tobacco risk messages or to a no message control condition', 'hookah tobacco risk messages']","['risk appraisals, attitudes towards hookah, ambivalence about hookah use, and willingness to smoke', 'risk appraisals', 'risk appraisals, attitudes, ambivalence, and willingness to smoke hookah', 'willingness to smoke', 'greater ambivalence', 'positive attitudes', 'Risk appraisals, attitudes, ambivalence, and willingness to smoke hookah']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",,0.0475978,"Those who viewed risk messages reported greater risk appraisals (M 4.50, SD 1.17 vs. M 3.87, SD 1.16,  ","[{'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}]",Health psychology and behavioral medicine,['10.1080/21642850.2020.1730844']
3015,33033665,Intensive Treatment of Lower-Limb Lymphedema and Variations in Volume Before and After: A Follow-Up.,"Background and objective Lymphedema is a clinical condition resulting from a failure in the drainage of the lymphatic system and the consequent formation of edema. The aim of the present study was to report the results of five days of intensive treatment for lymphedema and the maintenance of such results at the first follow-up evaluation. Method A clinical trial was conducted involving 409 patients with primary or secondary unilateral, lower-limb lymphedema who underwent intensive treatment with the Godoy method. The treatment consisted of eight hours per day of mechanical lymphatic drainage, 15 minutes per day of cervical stimulation, and compression mechanics involving the use of laced grosgrain (non-elastic) stockings alternated with bandages. Volumetric evaluations were performed at baseline, after five days of intensive treatment, and at the first follow-up evaluation performed one to three months after intensive treatment. Results The mean volume was 2,083.43 ml at baseline and 937.55 ml after five days of intensive treatment, corresponding to a 55% reduction. The mean was 800.83 ml at the follow-up evaluation, corresponding to a reduction of 137 ml [17.12 non-significant difference (p = 0.1)]. Conclusion The intensive treatment of lymphedema leads to considerable reductions in edema within a short period of time, facilitating the continuity of treatment and demonstrating the credibility of the method.",2020,"The mean volume was 2,083.43 ml at baseline and 937.55 ml after five days of intensive treatment, corresponding to a 55% reduction.","['409 patients with primary or secondary unilateral, lower-limb lymphedema who underwent intensive treatment with the Godoy method']","['mechanical lymphatic drainage, 15 minutes per day of cervical stimulation, and compression mechanics involving the use of laced grosgrain (non-elastic) stockings alternated with bandages']",['mean volume'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0398480', 'cui_str': 'Drainage of lymphatics'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",409.0,0.0228643,"The mean volume was 2,083.43 ml at baseline and 937.55 ml after five days of intensive treatment, corresponding to a 55% reduction.","[{'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Pereira de Godoy', 'Affiliation': 'Cardiology and Cardiovascular Surgery, São José do Rio Preto School of Medicine (FAMERP), São José do Rio Preto, BRA.'}, {'ForeName': 'Maria de Fatima', 'Initials': 'MF', 'LastName': 'Guerreiro Godoy', 'Affiliation': 'Medicine, São José do Rio Preto School of Medicine (FAMERP), São José do Rio Preto, BRA.'}, {'ForeName': 'Stelamarys', 'Initials': 'S', 'LastName': 'Barufi', 'Affiliation': 'Rehabilitation Service, Clínica Godoy, São José do Rio Preto, BRA.'}, {'ForeName': 'Henrique Jose', 'Initials': 'HJ', 'LastName': 'Pereira de Godoy', 'Affiliation': 'General Practice, Clínica Godoy, São José do Rio Preto, BRA.'}]",Cureus,['10.7759/cureus.10756']
3016,33033746,A study protocol for the development of a multivariable model predicting 6- and 12-month mortality for people with dementia living in residential aged care facilities (RACFs) in Australia.,"Background


For residential aged care facility (RACF) residents with dementia, lack of prognostic guidance presents a significant challenge for end of life care planning. In an attempt to address this issue, models have been developed to assess mortality risk for people with advanced dementia, predominantly using long-term care minimum data set (MDS) information from the USA. A limitation of these models is that the information contained within the MDS used for model development was not collected for the purpose of identifying prognostic factors. The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting. This study will aim to develop a model to estimate 6- and 12-month mortality risk for people with dementia from prognostic indicators recorded during usual clinical care provided in RACFs in Australia.
Methods


A secondary analysis will be conducted for a cohort of people with dementia from RACFs participating in a cluster-randomized trial of a palliative care education intervention (IMPETUS-D). Ten prognostic indicator variables were identified based on a literature review of clinical features associated with increased mortality for people with dementia living in RACFs. Variables will be extracted from RACF files at baseline and mortality measured at 6 and 12 months after baseline data collection. A multivariable logistic regression model will be developed for 6- and 12-month mortality outcome measures using backwards elimination with a fractional polynomial approach for continuous variables. Internal validation will be undertaken using bootstrapping methods. Discrimination of the model for 6- and 12-month mortality will be presented as receiver operating curves with c statistics. Calibration curves will be presented comparing observed and predicted event rates for each decile of risk as well as flexible calibration curves derived using loess-based functions.
Discussion


The model developed in this study aims to improve clinical assessment of mortality risk for people with dementia living in RACFs in Australia. Further external validation in different populations will be required before the model could be developed into a tool to assist with clinical decision-making in the future.",2020,The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting.,"['people with dementia from RACFs participating in a cluster-randomized trial of a palliative care education intervention (IMPETUS-D', 'people with dementia living in RACFs in Australia', 'people with advanced dementia', 'people with dementia from prognostic indicators recorded during usual clinical care provided in RACFs in Australia', 'people with dementia living in RACFs', 'people with dementia living in residential aged care facilities (RACFs) in Australia']",[],['mortality risk'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3266593', 'cui_str': 'Palliative care education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.141374,The models developed using MDS data have had relatively modest ability to discriminate mortality risk and are difficult to apply outside the MDS setting.,"[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bicknell', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050 Australia.'}, {'ForeName': 'Wen Kwang', 'Initials': 'WK', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050 Australia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Maier', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050 Australia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'LoGiuidice', 'Affiliation': 'Department of Medicine and Aged Care, @AgeMelbourne, Melbourne Health-Royal Melbourne Hospital, University of Melbourne, 6 North Main Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050 Australia.'}]",Diagnostic and prognostic research,['10.1186/s41512-020-00085-0']
3017,33033754,SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study.,"STUDY QUESTIONS


The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact.
WHAT IS KNOWN ALREADY


Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication.
STUDY DESIGN SIZE DURATION


This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months.
PARTICIPANTS/MATERIALS SETTING METHODS


Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation.
STUDY FUNDING/COMPETING INTERESTS


This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication.
TRIAL REGISTRATION NUMBER


Dutch Trial Register (NTR 7447, http://www.trialregister.nl).
TRIAL REGISTRATION DATE


2 January 2019.
DATE OF FIRST PATIENT’S ENROLMENT


First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.",2020,The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months.,"['Patients with signs of deep endometriosis', '≥\u200918\xa0years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma', 'university and teaching hospitals in the Netherlands', 'Premenopausal women (age', 'patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted', 'women with an endometrioma', 'eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms', 'women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones', '100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total']",['SIZE'],"['pain on the NRS', 'successful pain reduction after 12 and 18\xa0months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact', 'numeric rating scale (NRS', 'successful pain reduction (-30% reduction of pain', 'pain and improving quality of life', 'successful pain reduction after 12 and 18\xa0months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas', 'effectiveness and cost-effectiveness', 'successful pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.252012,The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Barneveld', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Veth', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Sampat', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.'}, {'ForeName': 'A M F', 'Initials': 'AMF', 'LastName': 'Schreurs', 'Affiliation': 'Department of Reproductive Medicine, Endometriosis Center, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Methodology, Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'de Bie', 'Affiliation': 'Endometriosis Foundation of the Netherlands (Endometriose Stichting), Sittard, The Netherlands.'}, {'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Jansen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Centre, University of Leiden, Leiden, the Netherlands.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Klinkert', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital Arnhem, Arnhem, the Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash Medical Centre Melbourne, Melbourne, Australia.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Endometriosis Center, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J W M', 'Initials': 'JWM', 'LastName': 'Maas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands.'}]",Human reproduction open,['10.1093/hropen/hoz046']
3018,33034052,"Radiotherapy vs sequential DDGP and radiotherapy in newly diagnosed early NK/T cell lymphoma: A randomized, controlled, open-label, multicenter study.","To compare the efficacy and safety of radiotherapy (RT) and chemotherapy of pegaspargase, gemcitabine, cisplatin and dexamethasone (DDGP) combined with RT in newly diagnosed stage I-II natural killer/T-cell lymphoma (NKTL), we designed a randomized, controlled, open-label, multicenter clinical trial. Data from 65 I-II NKTL patients whose diagnoses were confirmed using immunohistochemistry were enrolled from January 2011 to December 2013 in the First Affiliated Hospital of Zhengzhou University. Patients were randomly divided into the RT group (n = 35) and the DDGP combined with RT group (n = 30). There was a difference between the Eastern Cooperative Oncology Group (ECOG) score in the two arms (P = 0.013). The complete response rate (CRR) and objective response rate (ORR) of DDGP combined with RT group were superior to those in the RT group (CRR: 73.3% vs 48.6%; ORR: 83.3% vs 60.0%, respectively). The 5-year progression-free survival (PFS) rate and overall survival (OS) rate in the DDGP combined with RT group were higher than those in the RT group (82.9% vs 56.5% for PFS, P = 0.023; 85.7% vs 60.4% for OS, P = 0.040), and treatment methods and lactate dehydrogenase (LDH) were independent risk factors. Myelosuppression (P < 0.001), gastrointestinal reactions (P < 0.001), abnormal liver function (P = 0.007), coagulation abnormalities (P < 0.001) and baldness (P < 0.001) were more likely to occur in the DDGP combined with RT group. In conclusion, DDGP combined with radiotherapy obviously obtained great efficacy and prolonged the survival time of patients, also the side effects were mild for stage I-II NKTL. This trial was registered at https://register.clinicaltrials.gov as #NCT01501136. This article is protected by copyright. All rights reserved.",2020,"Myelosuppression (P < 0.001), gastrointestinal reactions (P < 0.001), abnormal liver function (P = 0.007), coagulation abnormalities (P < 0.001) and baldness (P ","['newly diagnosed early NK/T cell lymphoma', 'newly diagnosed stage I-II natural killer/T-cell lymphoma (NKTL', '65 I-II NKTL patients whose diagnoses were confirmed using immunohistochemistry were enrolled from January 2011 to December 2013 in the First Affiliated Hospital of Zhengzhou University']","['Radiotherapy vs sequential DDGP and radiotherapy', 'DDGP combined with RT', 'DDGP combined with radiotherapy', 'radiotherapy (RT) and chemotherapy of pegaspargase, gemcitabine, cisplatin and dexamethasone (DDGP) combined with RT']","['coagulation abnormalities', 'gastrointestinal reactions', 'complete response rate (CRR) and objective response rate (ORR) of DDGP', 'efficacy and safety', 'abnormal liver function', '5-year progression-free survival (PFS) rate and overall survival (OS) rate', 'survival time', 'Myelosuppression']","[{'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0558916', 'cui_str': 'NK/T-cell lymphoma, nasal and nasal-type'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0079772', 'cui_str': 'T-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",,0.105272,"Myelosuppression (P < 0.001), gastrointestinal reactions (P < 0.001), abnormal liver function (P = 0.007), coagulation abnormalities (P < 0.001) and baldness (P ","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Zhenchang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Jiaqin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Nan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}, {'ForeName': 'Wencai', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University: Lymphoma Diagnosed and Treatment Center of Henan Province, Zhengzhou, Henan, China.'}]",International journal of cancer,['10.1002/ijc.33329']
3019,33034099,Effect of topical marshmallow (Althaea officinalis) on atopic dermatitis in children: A pilot double-blind active-controlled clinical trial of an in-silico-analyzed phytomedicine.,"Atopic dermatitis (AD) is a chronic relapsing eczematous skin disease, which primarily affects infants and young children. Due to the side effects of commonly used drugs for its treatment, the development of safer therapeutic strategies is needed. There are many reports on the topical use of marshmallow (Althaea officinalis) for a range of skin diseases in Persian medicine. The main aim of the present investigation was evaluating the efficacy of marshmallow in children with mild-to-moderate atopic dermatitis. Another aim of the study was screening the anti-allergic and anti-inflammatory potential of phytocomponents against target proteins, including TNF-alpha, IL6, and PDEs A, B, and D enzymes with PDB IDs: 2AZ5, 1P9M, 3I8V, 4KP6, and 1Y2K, respectively, along with their respective standard ligands using computational docking analysis. A pilot clinical trial was designed to investigate the safety and efficacy of Althaea officinalis in children with AD. The diagnosis of AD was made according to the criteria of Hanifin and Rajka. Children between 3 months and 12 years old were participated in this trial and randomly allocated into two parallel intervention and control groups. The intervention group used Althaea officinalis 1% ointment while the positive control group used Hydrocortisone 1% ointment twice a day for a week and after that, three times per week for a period of 3 weeks. The severity of AD was measured using the SCORAD score at the end of each assessment visits. A total number of 22 patients completed the study. A significant decrease of the SCORAD score was observed in both groups. At the end of the study, this score change, which indicates the improvement of the patients was significantly higher in the intervention group in comparison to the baseline (p-value = .015) and week 1 (p-value = .018). In the docking analysis of the study, 33 phytochemical compounds were identified, which were docked into the active site of IL6, TNF-alpha, and human PDE4 isoenzymes. Affinity toward the selected enzymes was significantly higher in glycosylated compounds. The results of this pilot study showed that the efficacy of Althaea officinalis 1% ointment in a decrease of disease severity is more than Hydrocortisone 1% in children with AD. However, further studies are needed to confirm this finding. Moreover, the docking analysis revealed that the inhibitory activity of compounds with free hydroxyl groups such as glycosylated compounds was better than others, probably due to the hydrogen bond interaction of hydroxyl groups of the ligands with the enzymes.",2020,"At the end of the study, this score change, which indicates the improvement of the patients was significantly higher in the intervention group in comparison to the baseline (p-value = .015) and week 1 (p-value = .018).","['Children between 3\u2009months and 12\u2009years old', 'children with AD', 'children with mild-to-moderate atopic dermatitis', 'atopic dermatitis in children', 'A total number of 22 patients completed the study']","['topical marshmallow (Althaea officinalis', 'Althaea officinalis 1% ointment while the positive control group used Hydrocortisone 1% ointment', 'Hydrocortisone', 'Althaea officinalis']","['disease severity', 'severity of AD', 'safety and efficacy', 'SCORAD score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0330527', 'cui_str': 'Malva parviflora'}, {'cui': 'C1070217', 'cui_str': 'Althaea'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",33.0,0.0298898,"At the end of the study, this score change, which indicates the improvement of the patients was significantly higher in the intervention group in comparison to the baseline (p-value = .015) and week 1 (p-value = .018).","[{'ForeName': 'Vahedeh', 'Initials': 'V', 'LastName': 'Naseri', 'Affiliation': ""Pediatrics Infectious Research Center, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Chavoshzadeh', 'Affiliation': ""Pediatrics Infectious Research Center, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Mizani', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Daneshfard', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ghaffari', 'Affiliation': 'School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Abbas-Mohammadi', 'Affiliation': 'Department of Organic Chemistry, Faculty of Chemistry, University of Kashan, Kashan, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Gachkar', 'Affiliation': 'Infectious Disease and Tropical Medicine Reseaerch Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Jafari Hajati', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bahaeddin', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Deptartment of Biostatistics, School of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6899']
3020,33034123,Beverage-specific situational norms: Evidence from the Dutch electronic appropriate beverage task.,"INTRODUCTION AND AIMS


By the time young adolescents initiate alcohol consumption they have firmly established attitudes, expectations and beliefs about alcohol and its effects. To further unravel the origins of this knowledge in childhood, we aim to address Dutch children's knowledge of the types of alcoholic beverages adults typically consume in certain situational contexts (i.e. their knowledge of beverage-specific situational norms).
DESIGN AND METHODS


A total of 329 children (4-8 years old) completed the Dutch electronic Appropriate Beverage Task at three-time points (2015, 2016, 2017). Three-level regression models were estimated examining whether children's beverage-specific situational norms depend on the gender of the person displayed in the task, sex of the participant and whether there were any beverage-specific changes over time.
RESULTS


Beverage-specific findings seem to be robust across the appropriateness of the situation. Beer was the most frequently attributed alcoholic beverage overall and across the common drinking situations. White wine was attributed significantly more to females in the task. Beer, red wine and champagne were attributed significantly more to males. Attributions of individual alcoholic beverages did not change significantly over time. There were no significant differences between the participating boys and girls.
DISCUSSION AND CONCLUSIONS


Results suggest that 4-8-year olds are yet to form knowledge of beverage-specific situational norms. Independent of the situation, time and participants' sex, the gender of the person displayed in the task seemed to be more salient to children than situational or environmental indicators in determining consumption.",2020,Attributions of individual alcoholic beverages did not change significantly over time.,"['329 children (4-8\u2009years old) completed the Dutch electronic Appropriate Beverage Task at three-time points (2015, 2016, 2017']",[],['red wine and champagne'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0349371', 'cui_str': 'Red wine'}]",329.0,0.0337118,Attributions of individual alcoholic beverages did not change significantly over time.,"[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Smit', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Voogt', 'Affiliation': 'Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13189']
3021,33034145,"Effect of piroxicam administration on outcome of frozen-thawed embryo transfer: A randomized, double-blinded, placebo-controlled trial.","AIM


This study aimed to evaluate the effect of piroxicam adjuvant therapy on the clinical and biochemical pregnancy rate in patients undergoing in vitro fertilization (IVF) and frozen-thawed embryo transfer (ET) cycles.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 178 patients eligible for IVF-ET received either single dose of piroxicam 1-2 h before frozen-thawed ET or a placebo at the same time. Study participants were then followed and compared regarding the primary outcome of the study, which was biochemical (positive β-human chorionic gonadotrophin test) and clinical pregnancy (detected fetal heart beat in ultrasound) rate.
RESULTS


The results of this study indicated that there is no significant association between the piroxicam administration before frozen-thawed ET and the clinical or biochemical pregnancy rate (P = 0.208 and P = 0.699, respectively).
CONCLUSION


The findings of the current study suggest that piroxicam administration before ET has no beneficial effects on pregnancy rate among women undergoing IVF and frozen-thawed ET. However, further studies with larger sample sizes and longer follow-ups are recommended.",2020,The findings of the current study suggest that piroxicam administration before ET has no beneficial effects on pregnancy rate among women undergoing IVF and frozen-thawed ET.,"['frozen-thawed embryo transfer', '178 patients eligible for IVF-ET', 'patients undergoing in vitro fertilization (IVF) and frozen-thawed embryo transfer (ET) cycles']","['piroxicam 1-2\u2009h before frozen-thawed ET or a placebo', 'placebo', 'piroxicam adjuvant therapy', 'piroxicam']","['biochemical (positive β-human chorionic gonadotrophin test) and clinical pregnancy (detected fetal heart beat in ultrasound) rate', 'clinical or biochemical pregnancy rate', 'pregnancy rate']","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",178.0,0.653162,The findings of the current study suggest that piroxicam administration before ET has no beneficial effects on pregnancy rate among women undergoing IVF and frozen-thawed ET.,"[{'ForeName': 'Afsoon', 'Initials': 'A', 'LastName': 'Zarei', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Homayoon', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Atefe', 'Initials': 'A', 'LastName': 'Hashemi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davoodi', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Razavi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghasempour', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shaghayegh Moradi', 'Initials': 'SM', 'LastName': 'Alamdarloo', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14521']
3022,33034157,Exploring correlates of improved depression symptoms and quality of life following tai chi exercise for patients with heart failure.,"AIMS


Tai chi exercise has been shown in a prior randomized controlled trial to improve depression symptoms and quality of life (QoL) in patients with heart failure (HF), but correlates of these improvements are not well known. The purpose of this secondary analysis was to explore whether tai chi is associated with improvements in biopsychosocial and behavioural measures and whether such improvements are correlated with improved depression and QoL.
METHODS AND RESULTS


Participants were n = 100 adults with chronic systolic HF (mean age = 67.4, SD = 12.0; 64% male; 96% White; New York Heart Association class = 1-3) randomized to a 12 week tai chi exercise intervention or health education control. Constructs of interest included social support, exercise self-efficacy, activity engagement, sense of coherence, and inflammatory biomarkers. Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence. Among tai chi participants, improved self-efficacy was correlated with QoL (r = 31, P = 0.05), and there was a trend toward improved depression symptoms and social support (r = -0.22, P = 0.13). Among all participants, controlling for intervention group, improved sense of coherence, and inflammation (C-reactive protein) were associated with improved depression symptoms, and improved self-efficacy, sense of coherence, and frequency of activity engagement were associated with improved QoL.
CONCLUSIONS


Tai chi exercise promotes inter-related psychosocial improvements for patients with HF. A range of biopsychosocial and behavioural variables are relevant to mood management in patients with HF.",2020,"Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence.","['patients with heart failure (HF', 'patients with heart failure', 'Participants were n\xa0=\xa0100 adults with chronic systolic HF (mean age\xa0=\xa067.4, SD\xa0=\xa012.0; 64% male; 96% White; New York Heart Association class\xa0=\xa01-3', 'patients with HF']","['12\xa0week tai chi exercise intervention or health education control', 'Tai chi exercise', 'tai chi exercise']","['sense of coherence, and inflammation (C-reactive protein', 'social support or sense of coherence', 'depression symptoms and quality of life', 'depression symptoms, and improved self-efficacy, sense of coherence, and frequency of activity engagement', 'everyday activity engagement', 'depression symptoms and social support', 'depression symptoms and quality of life (QoL', 'self-efficacy', 'social support, exercise self-efficacy, activity engagement, sense of coherence, and inflammatory biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",100.0,0.0460636,"Tai chi was associated with increased everyday activity engagement compared with the health education group (P < 0.05), but there were no group differences in social support or sense of coherence.","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Coey', 'Affiliation': ""Department of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Department of Preventive Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Crute', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, 100 Cambridge St, 16th Floor, Boston, MA, 02114, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Division of General Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}]",ESC heart failure,['10.1002/ehf2.13046']
3023,33034409,"Ratio between negative and positive lymph nodes is a novel prognostic indicator for patients with esophageal cancer: A Surveillance, Epidemiology and End Results database analysis.","BACKGROUND


The aim of this study was to explore whether the ratio between negative and positive lymph nodes (R NP  ) could predict the overall survival (OS) of esophageal cancer (EC) patients with lymph node metastasis following esophagectomy.
METHODS


We utilized the Surveillance, Epidemiology and End Results (SEER) database to include the records of 2374 patients with lymph node metastases post-surgery. All patients were randomly assigned into the training cohort (n = 1424) and validation cohort (n = 950). Multivariate Cox regression analyses were performed to identify independent prognostic factors. A novel R NP  -based TR NP  M staging system was proposed. The prognostic value of N, R NP  , TNM and TR NP  M staging system was evaluated using the linear trend χ 2  test, likelihood ratio χ 2  test, and Akaike information criterion (AIC) to determine the potential superiorities. We constructed nomograms to predict survival in both cohorts, and the calibration curves confirmed the predictive ability.
RESULTS


Univariate analyses showed that N and R NP  stage significantly influenced the OS of patients. Multivariate analyses revealed that R NP  was an independent prognostic predictor in both the training and validation cohorts. For the stratification analysis in the two cohorts, we found significant differences in the prognosis of patients in different R NP  groups on the basis of the different N stages and the number of dissected lymph nodes. In addition, the lower AIC value of R NP  stage and TR NP  M staging system represented superior predictive accuracy for OS than the N stage and TNM staging system, respectively. Furthermore, the calibration curves for the probability of three- and five-year survival showed good consistency between nomogram predictive abilities and actual observation.
CONCLUSIONS


We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP  stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.",2020,"We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP  stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.","['2374 patients with lymph node metastases post-surgery', 'patients with esophageal cancer', 'esophageal cancer (EC) patients with lymph node metastasis following esophagectomy']",[],"['overall survival (OS', 'prognostic value of N, R NP  , TNM and TR NP  M staging system']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",2374.0,0.0712769,"We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP  stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.","[{'ForeName': 'Wanyi', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Huagang', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Hongdian', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Yueyang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Immunology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}]",Thoracic cancer,['10.1111/1759-7714.13688']
3024,33034421,"An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).","INTRODUCTION


Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.
METHODS


UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring ®  (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.
RESULTS


Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring ®  users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring ®  , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.
CONCLUSIONS


Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.",2020,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"['Young women in Southern Africa', 'HIV prevention in youth', 'female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose', '180 participants screened, 130 were enrolled and randomized to the Nuvaring ®  (n\xa0=\xa045), injection (n\xa0=\xa045) or', 'healthy, HIV-uninfected, female adolescents aged 15 to 19\xa0years, as a proxy for similar HIV prevention methods', 'adolescent girls and young women']","['COC', 'bi-monthly injectable contraceptive, monthly vaginal Nuvaring ®  or daily combined oral contraceptive (COC']","['acceptability and preference', 'changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods', 'contraceptive acceptability and preference']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001746', 'cui_str': 'Southern Africa'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1744678', 'cui_str': 'NuvaRing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",130.0,0.0785338,Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring ®  (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034).,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Pidwell', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mendelsohn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Centre for Infectious Diseases Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Slack', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Strode', 'Affiliation': 'HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fynn', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Cancer Association of South Africa, Johannesburg, South Africa.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jaspan', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Passmore', 'Affiliation': 'Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Hosek', 'Affiliation': 'Stroger Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Smit', 'Affiliation': 'MSD (Pty) Ltd, Halfway House, South Africa.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25626']
3025,33034429,"Effects of white noise in walking on walking time, state anxiety, and fear of falling among the elderly with mild dementia.","OBJECTIVE


This study aimed to analyze the effects of white noise in walking on the walking time, state anxiety, and fear of falling of the elderly with mild dementia.
METHODS


Subjects were 32 elderlies with mild dementia, and they divided into experimental group and control group, respectively. In the experimental group, walking program with white noise was applied 3 times a week for 4 weeks. White noise was provided by white noise generator in walking program. In the control group, walking program only was applied. To measure the effect of white noise in walking among the subjects, the walking time, state anxiety, and fear of falling were measured. Walking time was measured by Timed Up and Go test. State anxiety related in walking was measured by Korean version of State-Trait Anxiety Inventory. Fear of falling was used by Korean Falls Efficacy Scale.
RESULTS


The results of walking time showed the increase in both groups, but the statistically significant difference was not shown. However, the results of state anxiety and fear of falling showed decrease and the statistically significant difference was shown (p < .01). In comparative analysis, the statistically significant difference in the results of gate velocity between groups was not shown. However, in the results of state anxiety and fear of falling the statistically significant difference between groups was shown (p < .01).
CONCLUSIONS


White noise in walking should be induced positively to decrease the state anxiety and fear of falling in walking among elderly with mild dementia. Thus, in their environment, to decrease of state anxiety and fear of falling occurring in walking, the application of white noise in walking situation should be considered to apply for them.",2020,"The results of walking time showed the increase in both groups, but the statistically significant difference was not shown.","['elderly with mild dementia', 'Subjects were 32 elderlies with mild dementia, and they divided into experimental group and control group, respectively']",['white noise in walking'],"['walking time', 'State anxiety related in walking was measured by Korean version of State-Trait Anxiety Inventory', 'Fear of falling was used by Korean Falls Efficacy Scale', 'state anxiety and fear of falling occurring in walking', 'state anxiety and fear of falling in walking', 'walking time, state anxiety, and fear of falling', 'gate velocity', 'state anxiety and fear of falling', 'Walking time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",32.0,0.0123263,"The results of walking time showed the increase in both groups, but the statistically significant difference was not shown.","[{'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Son', 'Affiliation': 'Department of Occupational Therapy, Joenju Kijeon College, Jeonju, South Korea.'}, {'ForeName': 'Sung-Won', 'Initials': 'SW', 'LastName': 'Kwag', 'Affiliation': 'Department of Emergency Medical Rehabilitation Service, Graduate School of Kangwon National University, Samcheok, South Korea.'}]",Brain and behavior,['10.1002/brb3.1874']
3026,33034437,Efficacy of Certolizumab Pegol in naïve versus multi-treated patients affected by psoriatic arthritis.,"BACKGROUND


The efficacy and safety of Certolizumab Pegol over 52 weeks was compared in two groups of patients: Group 1 comprised patients naïve to biologic treatments; Group 2 comprised patients previously treated with one or more anti-Tumor necrosis factor (TNF)-alpha and/or antiinterleukin (IL) agents.
METHODS


We reported results in 50 patients affected by both mild psoriasis (PsO) and psoriatic arthritis (PsA). Primary endpoint was a reduction from baseline at week 52 of Disease Activity Score (DAS44-ESR) in both groups of patients. Secondary endpoints were a reduction from baseline at week 52 of Psoriasis Area Severity Index (PASI), Visual Analog Scale for Pain (PAIN VAS), ESR, CRP, and Dermatology life quality index (DLQI).
RESULTS


We observed a statistically significant improvement of both cutaneous and rheumatic disease in all patients, with a consistent reduction of DAS44-ESR, PASI, and PAIN VAS from baseline to week 52. DAS44-ESR decreased from 3.9 at BL to 1.5 at W52 (Group 1), and from 3.8 to 1.7 at W52 (Group 2). Mean PASI score decreased from 3.2 at baseline (BL) to 0.4 at W52 (Group 1), and from 5.4 to 0.7 at W52 (Group 2). Mean PAIN-VAS decreased from a value of 73.5 at BL to 2.5 at W52 (Group 1), and from a value of 62.4 at BL to 9.2 at W52 (Group 2). We also found a reduction in ESR, CRP and DLQI values for each time point.
CONCLUSIONS


Our results confirm that CZP can be administered safely and effectively to treat both psoriasis and psoriatic arthritis irrespective of previous treatments with biologic agents.",2020,Primary endpoint was a reduction from baseline at week 52 of Disease Activity Score (DAS44-ESR) in both groups of patients.,"['naïve versus multi-treated patients affected by psoriatic arthritis', '50 patients affected by both mild psoriasis (PsO) and psoriatic arthritis (PsA']","['CZP', 'biologic treatments; Group 2 comprised patients previously treated with one or more anti-Tumor necrosis factor (TNF)-alpha and/or antiinterleukin (IL) agents', 'Certolizumab Pegol']","['reduction from baseline at week 52 of Disease Activity Score (DAS44-ESR', 'ESR, CRP and DLQI values', 'DAS44-ESR', 'reduction from baseline at week 52 of Psoriasis Area Severity Index (PASI), Visual Analog Scale for Pain (PAIN VAS), ESR, CRP, and Dermatology life quality index (DLQI', 'Mean PASI score', 'Mean PAIN-VAS', 'cutaneous and rheumatic disease', 'DAS44-ESR, PASI, and PAIN VAS']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0054841', 'cui_str': 'carzinophilin'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}]",50.0,0.026356,Primary endpoint was a reduction from baseline at week 52 of Disease Activity Score (DAS44-ESR) in both groups of patients.,"[{'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Dattola', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy - nancydattola@gmailcom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vollono', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Cannizzaro', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Raffaele D', 'Initials': 'RD', 'LastName': 'Caposiena Caro', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mazzilli', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Melino', 'Affiliation': 'Department of Experimental Medicine, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Candi', 'Affiliation': 'Department of Experimental Medicine, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Campione', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': 'Department of Dermatology, University of Rome &quot;Tor Vergata&quot;, Rome, Italy.'}]","Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia",['10.23736/S0392-0488.20.06623-7']
3027,33034510,Effect of Post-Ablation Monitoring Strategy on Long-term Outcome for Catheter Ablation of Persistent Atrial Fibrillation: A Sub-Study of the STAR AF II Trial.,,2020,,['Catheter Ablation of Persistent Atrial Fibrillation'],['Post-Ablation Monitoring Strategy'],[],"[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],,0.0265829,,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Conti', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, ON, Canada & University of Tor Vergata, Rome, Italy.'}, {'ForeName': 'Chen-Yang', 'Initials': 'CY', 'LastName': 'Jiang', 'Affiliation': 'Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': 'Department of Cardiology, Oxford University Hospitals, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Haukeland University Hospital, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Deisenhofer', 'Affiliation': 'Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mantovan', 'Affiliation': ""Ospedale S. Maria di Ca' Foncelli, Treviso, Italy.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Rukshen', 'Initials': 'R', 'LastName': 'Weerasooriya', 'Affiliation': 'Department of Cardiology, Hollywood Private Hospital, Nedlands & University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Albenque', 'Affiliation': 'Departement de Rythmologie, Clinique Pasteur Toulouse, Toulouse, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nardi', 'Affiliation': 'Pineta Grande Hospital, Castel Volturno, Italy.'}, {'ForeName': 'Endrj', 'Initials': 'E', 'LastName': 'Menardi', 'Affiliation': 'Ospedale Santa Croce e Carle, Cuneo, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide & Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Centre, Newmarket & University of Toronto, Toronto, ON, Canada.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008682']
3028,33030868,Association of a Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills: A Randomized Controlled Trial.,"OBJECTIVE


To assess whether a pediatric and adolescent gynecology electronic learning (eLearning) module improves knowledge and clinical performance among obstetrics and gynecology residents.
METHODS


We conducted a multi-institutional, single-blinded, randomized controlled trial across four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty. Applying permutated block randomization, residents were randomized to no intervention or completion of a validated eLearning module on prepubertal bleeding. All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding and an objective structured clinical examination that assessed history collection, performance of a prepubertal genital examination, vaginal culture, and vaginoscopy for a pediatric patient. Objective structured clinical examinations were videotaped and reviewed by two faculty, blinded to randomization group; interrater reliability score was 97%. We calculated descriptive frequencies and compared randomization groups using χ analyses and Fisher exact tests for categorical variables, and median tests for continuous variables; a value of P<.05 was considered significant.
RESULTS


From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments. Most were female (91%) and the majority reported limited pediatric and adolescent gynecology didactic or clinical experience, with 36% reporting prior didactics on prepubertal vaginal bleeding and 33% reporting prior exposure to the prepubertal genital examination. Forty-five participants (46%) were randomized to the module and groups were similar across training levels. Residents assigned to the module scored significantly higher on the knowledge assessment (4/5 vs 2/5, P<.001) and objective structured clinical examination (13/16 vs 7/16, P<.001) and were more likely to avoid a speculum in the examination of a pediatric patient (95.6% vs 57.7%, P<.001).
CONCLUSION


Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents. Applying this learning technique in other programs may help address deficiencies in pediatric and adolescent gynecology education and training.",2020,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"['Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills', 'All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding', 'From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments', 'four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty', 'Forty-five participants (46', 'obstetrics and gynecology residents']","['no intervention or completion of a validated eLearning module', 'pediatric and adolescent gynecology electronic learning (eLearning) module']","['knowledge assessment', 'prepubertal vaginal bleeding', 'knowledge and clinical performance', 'objective structured clinical examination', 'interrater reliability score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.111094,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Huguelet', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, and the Division of Pediatric and Adolescent Gynecology, Children's Hospital Colorado, Aurora, Colorado; Pediatric and Adolescent Gynecology, University of Louisville, Norton Healthcare, Louisville, Kentucky; the Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, Rhode Island; the Division of General Obstetrics and Gynecology, Department of Obstetrics, Gynecology and Newborn Care, the Ottawa Hospital, the Division of Gynecology, Department of Surgery, Children's Hospital of Eastern Ontario, and the Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada; the Department of Obstetrics and Gynecology, Virginia Commonwealth University School of Medicine, Richmond, Virginia; and the Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Abraham', 'Affiliation': ''}, {'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Alaniz', 'Affiliation': ''}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Dolinko', 'Affiliation': ''}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Dumont', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Karjane', 'Affiliation': ''}, {'ForeName': 'Janina V', 'Initials': 'JV', 'LastName': 'Pearce', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Guiahi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004098']
3029,33030881,Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial.,"OBJECTIVE


To evaluate whether the induction of labor in term gravid women with cervical dilation 2 cm or less and intact membranes by using oral misoprostol preceded by transcervical Foley bulb placement results in a significantly increased vaginal delivery rate compared with the use of oral misoprostol alone.
METHODS


We randomized the induction method by week of admission to labor and delivery, with each week group described as a cluster in a block randomized design. Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included. Study arms were either 100 micrograms of oral misoprostol after transcervical Foley bulb placement or 100 micrograms of oral misoprostol alone. The primary outcome was vaginal delivery with the first induction attempt. Secondary outcomes included time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes. We estimated that a sample size of 1,077 per arm was needed to detect a 5% increase in vaginal delivery rate with a type I error of 5% and power of 80%, accounting for interim analysis and cluster size of 30 inductions per week. This was a pragmatic trial, and analysis was by intention-to-treat.
RESULTS


From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters) were assigned to oral misoprostol plus Foley and 1,110 women (34 clusters) to oral misoprostol alone. Demographic characteristics were similar. Vaginal delivery at the first induction occurred in 78% of the misoprostol plus Foley arm and in 77% of the misoprostol arm (relative risk [RR] 1.00; 95% CI 0.96-1.05; adjusted relative risk [aRR], 1.00; 95% CI 0.95-1.05). Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56). There were no differences in neonatal outcomes.
CONCLUSION


Induction of labor in gravid women at term with intact membranes by using oral misoprostol plus Foley bulb did not result in a higher vaginal delivery rate, but it did result in more clinical chorioamnionitis compared with the use of oral misoprostol alone.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03407625.",2020,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"['gravid women at term with intact membranes', 'From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters', 'term gravid women with cervical dilation 2 cm or less and intact membranes', 'Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included']","['misoprostol', 'oral misoprostol', 'oral misoprostol plus Foley', 'oral misoprostol alone', 'misoprostol alone']","['neonatal outcomes', 'Vaginal delivery', 'Clinical chorioamnionitis', 'vaginal delivery with the first induction attempt', 'vaginal delivery rate', 'time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",,0.370732,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"[{'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Adhikari', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McIntire', 'Affiliation': ''}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004123']
3030,33030983,Efficacy of L-Leucine Supplementation Coupled with a Calorie-Restricted Diet to Promote Weight Loss in Mid-Life Women.,"OBJECTIVE


This study evaluated the effect of leucine supplementation coupled with a calorie-restricted diet over a 12-week period in mid-life overweight and obese women on body composition and resting metabolic rate (RMR).
METHOD


This study was a randomized, single-blind, placebo-controlled trial in which 34 women were randomly assigned to either 10 g leucine (LEU) or placebo daily, while following a calorie-restricted diet A dual energy x-ray absorptiometry (DXA) analysis, metabolic rate assessment via a BodyGem® and anthropometrics were performed at baseline and after the 12-week study to determine changes in fat mass, lean mass and RMR. Main variables were analyzed using 2 (condition) by 2 (time) mixed design ANOVAs with repeated measures. Odds ratio was calculated by counting the number of individuals gaining or maintaining lean mass ( p  ≤ .05).
RESULTS


Both groups lost a significant amount of weight due to both fat and lean mass loss, but there was no significant difference between groups, with RMR remaining unchanged over the course of the study and not significantly different between groups. The loss in lean mass was noticeably less, though not statistically significant ( p  = 0.644) for the women in the LEU group, with 38% vs. 6%, gaining or retaining lean mass during the intervention relative to the placebo.
CONCLUSIONS


Our findings demonstrate that a greater proportion of mid-life overweight or obese women taking LEU supplements gained or maintained lean mass during intentional weight loss, though it did not reach a level of statistical significance.",2020,"The loss in lean mass was noticeably less, though not statistically significant ( p  = 0.644) for the women in the LEU group, with 38% vs. 6%, gaining or retaining lean mass during the intervention relative to the placebo.
","['mid-life overweight and obese women', 'Mid-Life Women', '34 women']","['leucine supplementation coupled with a calorie-restricted diet', 'placebo', '10\u2009g leucine (LEU) or placebo daily, while following a calorie-restricted diet A dual energy x-ray absorptiometry (DXA) analysis, metabolic rate assessment via a BodyGem® and anthropometrics', 'L-Leucine Supplementation Coupled with a Calorie-Restricted Diet']","['body composition and resting metabolic rate (RMR', 'weight due to both fat and lean mass loss', 'Odds ratio', 'Weight Loss', 'loss in lean mass']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",34.0,0.201026,"The loss in lean mass was noticeably less, though not statistically significant ( p  = 0.644) for the women in the LEU group, with 38% vs. 6%, gaining or retaining lean mass during the intervention relative to the placebo.
","[{'ForeName': 'LesLee', 'Initials': 'L', 'LastName': 'Funderburk', 'Affiliation': 'Family & Consumer Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Heileson', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1815607']
3031,33030989,Randomized Controlled Trial of Healthy Harlem's Get Fit Program: An After-School Intervention for Childhood Overweight and Obesity in the Harlem Children's Zone.,"Background:  Although the increases in overweight and obesity observed for several decades have appeared to have leveled off, the prevalence of overweight and obesity remains exceptionally high among children of color. This article estimates the effect of Healthy Harlem's Get Fit-a 12-week after-school program aimed at helping students improve physical activity and eating habits-on BMI and weight status of adolescents.  Methods:  Participants were 436 students who had overweight or obesity in 12 Harlem Children's Zone after-school programs in New York. The evaluation was a randomized controlled trial where students were assigned to an intervention group that received Get Fit plus Prevention services or a control group that only received Prevention services in 2013 or 2014. Impacts were assessed on BMI z-score, percentage with overweight or obesity, and percentage with obesity using regression analysis.  Results:  Relative to the control group, students randomized to Get Fit experienced a decrease in BMI z-score (mean difference = -0.04;  p  = 0.02). The percentage of students with overweight or obesity was also lower (mean difference = -5.3;  p  = 0.02), but there was no effect on the percentage of students with obesity. Get Fit had an impact on BMI for girls, but not boys.  Conclusions:  Get Fit improved middle- and high-school students' BMI outcomes and weight status. Schools continue to face pressure to allocate time for physical education and activity while meeting their academic demands, underscoring the importance of after-school student-level interventions like Get Fit.",2020,students randomized to Get Fit experienced a decrease in BMI z-score (mean difference = -0.04;  p  = 0.02).,"[""Participants were 436 students who had overweight or obesity in 12 Harlem Children's Zone after-school programs in New York"", ""Healthy Harlem's Get Fit Program""]","['Get Fit plus Prevention services or a control group that only received Prevention services', 'School Intervention']","['BMI z-score', 'percentage of students with overweight or obesity', 'BMI z-score, percentage with overweight or obesity', 'Childhood Overweight and Obesity', 'physical activity and eating habits-on BMI and weight status of adolescents']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4521075', 'cui_str': 'Overweight in childhood'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",12.0,0.0429374,students randomized to Get Fit experienced a decrease in BMI z-score (mean difference = -0.04;  p  = 0.02).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mabli', 'Affiliation': 'Human Services Unit, Mathematica, Cambridge, MA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Bleeker', 'Affiliation': 'Human Services Unit, Mathematica, Princeton, NJ, USA.'}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Fox', 'Affiliation': 'Human Services Unit, Mathematica, Cambridge, MA, USA.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Jean-Louis', 'Affiliation': ""Harlem Children's Zone, New York, NY, USA.""}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Fox', 'Affiliation': ""Harlem Children's Zone, New York, NY, USA.""}]",Childhood obesity (Print),['10.1089/chi.2020.0012']
3032,33030992,"Demographic, Social, and Personal Factors Associated with Lactation Cessation by 6 Weeks in Mothers of Very Low Birth Weight Infants.","BACKGROUND


Although mother's own milk decreases prematurity-associated morbidities, mothers of infants born preterm and very low birth weight experience a significantly shorter lactation duration. Little is known regarding factors associated with lactation cessation during the hospitalization of a very low birth weight infant.
RESEARCH AIM


To determine demographic, social, and personal factors associated with lactation cessation by 6-weeks postpartum in mothers delivering very low birth weight infants.
METHODS


We used a retrospective, longitudinal, two-group comparison design using data from a randomized control study. Mothers of very low birth weight infants ( N  = 142) were enrolled from a labor and delivery unit associated with a Level 4 neonatal intensive care unit. Demographic, social, and health information was obtained from the medical records. Participants were surveyed regarding lactation goals, experience, and reason(s) for cessation.
RESULTS


Participants who did not continue lactating for more than 6 weeks were more likely to be unemployed ( p  = .019), Medicaid eligible ( p  = .009), less educated ( p  < .031), smoke ( p  = .002), provide less skin-to-skin care ( p  = .007), and to delay the decision to provide their milk to their infant ( p  = .007). After Bonferroni adjustment, only minutes of skin-to-skin care remained statistically significant. Insufficient maternal milk production was the most common reason for lactation cessation.
CONCLUSION


While the etiology of lactation cessation is often non-modifiable, strategies aimed at maintaining mother's own milk production, smoking cessation, increasing skin-to-skin care, and promoting an earlier decision to lactate, may prolong lactation duration in this vulnerable population.This RCT was registered (2012-00071) with ClinicalTrials.com on 6/28/2013.",2020,"RESULTS


Participants who did not continue lactating for more than 6 weeks were more likely to be unemployed ( p  = .019), Medicaid eligible ( p  = .009), less educated ( p  < .031), smoke ( p  = .002), provide less skin-to-skin care ( p  = .007), and to delay the decision to provide their milk to their infant ( p  = .007).","['Participants were surveyed regarding lactation goals, experience, and reason(s) for cessation', 'Mothers of Very Low Birth Weight Infants', 'Mothers of very low birth weight infants ( N  = 142) were enrolled from a labor and delivery unit associated with a Level 4 neonatal intensive care unit', 'mothers delivering very low birth weight infants']",[],"['Demographic, social, and health information', 'provide less skin-to-skin care', 'Demographic, Social, and Personal Factors']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]",142.0,0.0615023,"RESULTS


Participants who did not continue lactating for more than 6 weeks were more likely to be unemployed ( p  = .019), Medicaid eligible ( p  = .009), less educated ( p  < .031), smoke ( p  = .002), provide less skin-to-skin care ( p  = .007), and to delay the decision to provide their milk to their infant ( p  = .007).","[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': '3463 University of Florida, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Krueger', 'Affiliation': '3463 University of Florida, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': '3463 University of Florida, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': '50546 Medical University of South Carolina, Charleston, USA.'}]",Journal of human lactation : official journal of International Lactation Consultant Association,['10.1177/0890334420940239']
3033,33028383,"Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failure of up-to-date rehabilitation.","BACKGROUND


The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial.
METHODS


This study is a single-center, randomized double-blind controlled trial, preceded by a case series. All the 232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused extracorporeal shock waves therapy. This rehabilitation program is expected to have a maximum success rate 75%. It is therefore aimed to allocate a minimum of 58 patients with rehabilitation failure into the 1:1 randomized trial. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo an ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (control group). The primary endpoint will be the pain improvement from baseline (month 0) at 3 months on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons.
DISCUSSION


The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03987256. Registered on 20 August 2019.",2020,"The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons.
","['58 patients with rehabilitation failure', '232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused']","['platelet-rich plasma (PRP', 'ultrasound (US)-guided needling combined with either PRP (intervention group) or saline', 'PRP', 'extracorporeal shock waves therapy', 'needling with and without platelet-rich plasma']","['pain improvement from baseline (month 0) at 3\u2009months on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle', 'rehabilitation success rate and improvements from baseline at 3, 6, and 12\u2009months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.11914,"The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons.
","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Schwitzguebel', 'Affiliation': ""Sports Medicine Division, La Providence Hospital, Fbg de l'Hopital 81, 2000, Neuchâtel, Switzerland. adrien.schwitzguebel@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bogoev', 'Affiliation': 'Giant Studio, Rue des Noyers 2, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nikolov', 'Affiliation': 'Giant Studio, Rue des Noyers 2, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ichane', 'Affiliation': 'Service Médecine interne, Groupe Hospitalier Est Reunion, 30 rte Nationale 3 - ZAC Madeleine, 186 97470, Saint Benoît, BP, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lädermann', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Rue J.-D. Maillard 3, 1217, Meyrin, Switzerland.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01998-8']
3034,33028387,'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial.,"BACKGROUND


With high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives. Uptake of HIV services worldwide is hindered by stigma towards persons living with HIV/AIDS. While cultural context plays a key role in shaping HIV stigma, these insights have not yet been fully integrated into stigma reduction strategies. By utilizing the ""What Matters Most"" stigma framework, we propose that an intervention to counter culturally salient aspects of HIV stigma will improve treatment adherence and other relevant outcomes. A pragmatic clinical trial in Botswana will evaluate the ""Mothers Moving towards Empowerment"" (MME) intervention, which seeks to address HIV stigma in Botswana and to specifically engage pregnant mothers so as to promote antiretroviral therapy (ART) adherence in the postpartum period.
METHODS


This study will test MME against treatment as usual (TAU) among pregnant mothers diagnosed with HIV and their infants. Outcomes will be assessed during pregnancy and 16 weeks postpartum. Women who meet eligibility criteria are assigned to MME or TAU. Women assigned to MME are grouped with others with similar estimated delivery dates, completing up to eight intervention group sessions scheduled before week 36 of their pregnancies. Primary outcomes among mothers include (i) reducing self-stigma, which is hypothesized to mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART. We will also examine a set of follow-up infant birth outcomes (APGAR score, preterm delivery, mortality (at < 16 weeks), birth weight, vaccination record, and HIV status).
DISCUSSION


Our trial will evaluate MME, a culturally based HIV stigma reduction intervention using the ""What Matters Most"" framework, to reduce stigma and improve treatment adherence among pregnant women and their infants. This study will help inform further refinement of MME and preparation for a future large-scale, multisite, randomized controlled trial (RCT) in Botswana.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03698981 . Registered on October 8, 2018.",2020,Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives.,"['Pregnant women who are living with HIV', 'pregnant mothers diagnosed with HIV and their infants', 'pregnant women living with HIV in Botswana', 'pregnant women and their infants', 'persons living with HIV/AIDS']","['MME or TAU', 'MME', ""Mothers moving towards empowerment' intervention"", 'Mothers Moving towards Empowerment"" (MME) intervention']","['mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART', 'infant birth outcomes (APGAR score, preterm delivery, mortality (at <\u200916\u2009weeks), birth weight, vaccination record, and HIV status', 'mothers include (i) reducing self-stigma']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.219555,Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives.,"[{'ForeName': 'Ohemaa B', 'Initials': 'OB', 'LastName': 'Poku', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States. opoku1@jh.edu.'}, {'ForeName': 'Ari R', 'Initials': 'AR', 'LastName': 'Ho-Foster', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Patlo', 'Initials': 'P', 'LastName': 'Entaile', 'Affiliation': 'Botswana-UPenn Partnership, Gaborone, Botswana.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'New York University, New York, NY, United States.'}, {'ForeName': 'Haitisha', 'Initials': 'H', 'LastName': 'Mehta', 'Affiliation': 'Columbia University, New York, NY, United States.'}, {'ForeName': 'Shathani', 'Initials': 'S', 'LastName': 'Rampa', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'New York University, New York, NY, United States.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Arscott-Mills', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Eschliman', 'Affiliation': 'Columbia University, New York, NY, United States.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jackson', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Tadele', 'Initials': 'T', 'LastName': 'Melese', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Becker', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Eisenberg', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Link', 'Affiliation': 'University of California Riverside, Riverside, CA, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Go', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hil, NC, USA.'}, {'ForeName': 'Philip Renison', 'Initials': 'PR', 'LastName': 'Opondo', 'Affiliation': 'University of Botswana, Gaborone, Botswana.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Blank', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Yang', 'Affiliation': 'New York University, New York, NY, United States.'}]",Trials,['10.1186/s13063-020-04676-6']
3035,33028390,Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis-study protocol for a randomized controlled trial.,"BACKGROUND


Glenohumeral osteoarthritis can, in the most severe cases, require surgery with insertion of a shoulder arthroplasty. A design with a stem in the humeral bone canal is currently regarded as the standard treatment option in patients who have an intact rotator cuff function, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component, stem-related complications can be reduced. The aim of this study is to compare the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive stemmed total shoulder arthroplasty (control group).
MATERIALS AND METHODS


This is a randomized controlled trial comparing the stemless and the stemmed total shoulder arthroplasty. All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be offered participation. The following exclude from participation: below 18 years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff, poor bone quality, and ASA groups 4-5. A total of 122 patients will be included of which 56 will be part of a radiostereometric analysis (RSA) study of humeral component migration. The primary outcomes are magnitude of migration of the humeral component assessed by RSA and patient-reported outcome by Western Ontario Osteoarthritis of the Shoulder index (WOOS). The secondary outcomes are additional patient-reported outcomes, functional outcome, readmission, complications, revisions, and changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost-utility analysis). The patients are examined before the operation and 3, 6, 12, and 24 months postoperative.
DISCUSSION


To our knowledge, RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function in a randomized clinical trial. Today, the two designs are considered equal in the treatment of osteoarthritis. The study will provide surgeons and patients with information about shoulder arthroplasty for osteoarthritis and assist them in decision-making.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04105478 . Registered on 25 September 2019.",2020,All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be offered participation.,"['patients who have an intact rotator cuff function', 'participation: below 18\u2009years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff, poor bone quality, and ASA groups 4-5', 'All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte', '122 patients will be included of which 56 will be part of a radiostereometric analysis (RSA) study of humeral component migration']",['Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive stemmed total shoulder arthroplasty (control group'],"['additional patient-reported outcomes, functional outcome, readmission, complications, revisions, and changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost-utility analysis', 'magnitude of migration of the humeral component assessed by RSA and patient-reported outcome by Western Ontario Osteoarthritis of the Shoulder index (WOOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}]","[{'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C1959591', 'cui_str': 'X-Ray Absorptiometry'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0409939', 'cui_str': 'Osteoarthritis of glenohumeral joint'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",122.0,0.0728764,All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte will be offered participation.,"[{'ForeName': 'Marc Randall Kristensen', 'Initials': 'MRK', 'LastName': 'Nyring', 'Affiliation': 'Department of Orthopedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. marc.randall.kristensen.nyring@regionh.dk.'}, {'ForeName': 'Bo S', 'Initials': 'BS', 'LastName': 'Olsen', 'Affiliation': 'Department of Orthopedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Müjgan', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Orthopedic Surgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Petersen', 'Affiliation': 'Department of Orthopedic Surgery, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jeppe V', 'Initials': 'JV', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04763-8']
3036,33028396,"Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial.","BACKGROUND


Natural products may provide a source for the discovery and development of adjunctive pharmacological interventions to modulate the inflammatory pathways contributing to chronic disease. Xanthohumol, a flavonoid from the hops plant (Humulus lupulus), has antioxidant and anti-inflammatory properties and may act as a prebiotic to the intestinal microbiota. Xanthohumol is not currently approved as a drug by the US Food and Drug Administration (FDA), but is available as a dietary supplement and ingredient in medical foods. To formally test the safety of xanthohumol, a phase I clinical trial (""XMaS"") was designed and approved under an Investigational New Drug application to the US FDA. The main objective is to examine the clinical safety and subjective tolerability of xanthohumol in healthy adults compared to placebo. Additional aims are to monitor biomarkers related to inflammation, gut permeability, bile acid metabolism, routes, and in vivo products of xanthohumol metabolism, and to evaluate xanthohumol's impact on gut microbial composition.
METHODS


The safety and tolerability of xanthohumol in healthy adults will be evaluated in a triple-masked, randomized, placebo-controlled trial. Participants will be randomized to either 24 mg/day of xanthohumol or placebo for 8 weeks. Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks. Participants will be queried for adverse events throughout the trial. Xanthohumol metabolites in blood, urine, and stool will be measured. Biomarkers to be evaluated include plasma tumor necrosis factor-alpha, various interleukins, soluble CD14, lipopolysaccharide-binding protein, fecal calprotectin, and bile acids to assess impact on inflammatory and gut permeability-related mechanisms in vivo. Stool samples will be analyzed to determine effects on the gut microbiome.
DISCUSSION


This phase I clinical trial of xanthohumol will assess safety and tolerability in healthy adults, collect extensive biomarker data for assessment of potential mechanism(s), and provide comparison data necessary for future phase II trials in chronic disease(s). The design and robustness of the planned safety and mechanistic evaluations planned provide a model for drug discovery pursuits from natural products.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03735420 . Registered on November 8, 2018.",2020,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.",['healthy adults'],"['xanthohumol or placebo', 'Xanthohumol', 'placebo', 'Xanthohumol microbiome', 'xanthohumol']","['safety and tolerability', 'clinical safety and subjective tolerability', 'Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures', 'Xanthohumol metabolites in blood, urine, and stool']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0536128', 'cui_str': 'xanthohumol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",,0.329114,"Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks.","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'National University of Natural Medicine, Portland, USA. rbradley@nunm.edu.'}, {'ForeName': 'Blake O', 'Initials': 'BO', 'LastName': 'Langley', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phipps', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stack', 'Affiliation': 'National University of Natural Medicine, Portland, USA.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Jansson', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Metz', 'Affiliation': 'Pacific Northwest National Laboratory, Richland, USA.'}, {'ForeName': 'Jan Frederik', 'Initials': 'JF', 'LastName': 'Stevens', 'Affiliation': 'Oregon State University, Corvallis, USA.'}]",Trials,['10.1186/s13063-020-04769-2']
3037,33028455,A randomised test of the effect of medical  v . lay idiom on assessment of perceived mental health condition in the USA.,"AIMS


To test the impact of using different idioms in epidemiological interviews on the prevalence and correlates of poor mental health and mental health service use.
METHODS


We conducted a randomised methodological experiment in a nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health'. Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
RESULTS


Respondents were about half as likely to endorse a problem when asked with the more medical idiom (18.1%) than when asked with the lay idiom (35.1%). The medical idiom had a significantly larger area under the ROC curve when compared against a validated measure of psychological distress than the lay idiom (0.91 v. 0.87, p = 0.012). The proportion of the population who endorsed a problem but did not receive treatment in the past year was less than half as large for the medical idiom (7.90%) than for the lay idiom (20.94%). Endorsement of problems differed in its associations with age, sex, race/ethnicity and self-rated health depending on the question idiom. For instance, the odds of endorsing problems were threefold higher in the youngest than the oldest age group when the medical idiom was used (OR = 3.07; 95% CI 1.47-6.41) but did not differ across age groups when the lay idiom was used (OR = 0.76; 95% CI 0.43-1.36).
CONCLUSION


Choice of idiom in epidemiological questionnaires can affect the apparent correlates of poor mental health and service use. Cultural change within populations over time may require changes in instrument wording to maintain consistency in epidemiological measurement of psychiatric conditions.",2020,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[""nationally representative sample of the US adult population, comparing a lay idiom, which asked about 'problems with your emotions or nerves' with a more medical idiom, which asked about 'problems with your mental health""]",['medical  v . lay idiom'],"['psychological distress', 'psychological distress), demographic characteristics, self-rated health and mental health service use', 'odds of endorsing problems', 'larger area under the ROC curve']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",,0.0553389,"Differences across study arms in the associations of endorsement of problems with the Kessler-6 (a validated assessment of psychological distress), demographic characteristics, self-rated health and mental health service use were examined.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breslau', 'Affiliation': 'RAND Corporation, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McBain', 'Affiliation': 'RAND Corporation, Boston, Massachusetts, USA.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Wong', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roth', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Burnam', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cefalu', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Collins', 'Affiliation': 'RAND Corporation, Santa Monica, California, USA.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000840']
3038,33028479,Social Networks of Clients in First-Time DUI Programs.,"OBJECTIVE


Social networks play an important role in the development of and recovery from problem drinking behaviors; however, few studies have measured the social networks of individuals convicted of driving under the influence (DUI) or assessed the relationship between social network characteristics and risk for DUI relapse and recidivism. The goal of this study is to describe the social network characteristics of a first-time DUI population in the 2 weeks before the DUI incident; examine demographic differences in social network characteristics by age, ethnicity, and gender; and assess the relationship between social network characteristics and risk factors for DUI.
METHOD


We collected personal (egocentric) social network survey data from 94 participants (65% male) enrolled in a randomized clinical trial comparing the effects of cognitive behavioral therapy with usual care for individuals convicted of a first-time DUI. Multivariate models were used to assess the relationship between pre-DUI personal network characteristics and risk factors for DUI measured at baseline interview.
RESULTS


Results indicate that the proportion of drinking partners in one's personal network was positively associated with drinks per week, binge drinking, alcohol use, marijuana use, and alcohol-related consequences. Several dimensions of personal network support were inversely associated with risk factors for DUI.
CONCLUSIONS


The pre-DUI composition of personal networks has a strong relationship to baseline risk factors for DUI; networks composed of more risky individuals (e.g., drinking partners) were associated with greater substance use and drinking and driving behaviors. Networks with greater levels of social support were associated with lower likelihood of self-reported driving after drinking and intentions to drive after drinking. Interventions that target positive and negative aspects of personal networks may enhance clinical treatments.",2020,Networks with greater levels of social support were associated with lower likelihood of self-reported driving after drinking and intentions to drive after drinking.,['94 participants (65% male) enrolled'],['cognitive behavioral therapy with usual care for individuals convicted of a first-time DUI'],"['binge drinking, alcohol use, marijuana use, and alcohol-related consequences']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1171335', 'cui_str': 'Driving Under the Influence'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",94.0,0.0237154,Networks with greater levels of social support were associated with lower likelihood of self-reported driving after drinking and intentions to drive after drinking.,"[{'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Portland State University, Portland, Oregon.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chan Osilla', 'Affiliation': 'RAND Corporation, Santa Monica, California.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kennedy', 'Affiliation': 'RAND Corporation, Santa Monica, California.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Paddock', 'Affiliation': 'NORC at the University of Chicago, Chicago, Illinois.'}]",Journal of studies on alcohol and drugs,[]
3039,33028480,Mentorship for Addiction Problems (MAP): A New Behavioral Intervention to Assist in the Treatment of Substance Use Disorders.,"OBJECTIVE


Mentorship for Addiction Problems (MAP) is a new behavioral treatment formalizing client-to-client mentorship relationships as an adjunct to standard outpatient substance use disorder treatment. We tested the preliminary efficacy of MAP in reducing substance use and associated barriers to successful treatment outcomes.
METHOD


A total of 65 participants (17 later recovery participants [LRPs] and 48 early recovery participants [ERPs]) with substance use disorders were randomized to MAP + Treatment as Usual (TAU) or TAU alone. Within MAP, for each cohort, a pool of 4-5 mentors (LRPs) was formed and engaged in mentoring activities for 24 weeks until 12-13 mentees (ERPs), newly admitted, had participated in MAP for 12 weeks. Behavioral and biological measures were conducted at baseline, weekly, monthly, and termination for all participants and during the 12-week follow-up for ERPs.
RESULTS


Substance use declined across both conditions for ERPs (N = 48) during treatment, Weeks 0-12 (p = .001); however, on average, ERPs in the MAP intervention used significantly fewer days than controls during Treatment Weeks 1-12 (p = .013) and during Follow-Up Weeks 13-24 (p = .043). Addiction Severity Index alcohol and drug use scores increased in TAU and decreased in MAP during Follow-Up Weeks 13-24 for ERPs, alcohol: b = -0.08, SE = 0.03, t(47) = -2.97, p = .005; drug use: b = -0.02, SE = 0.01, t(47) = -2.36, p = .023. In addition, there was high patient interest in MAP and good fidelity to delivery of treatment.
CONCLUSIONS


MAP shows promise assisting in the reduction of substance use early in treatment when vulnerability and risk for relapse is high and has a positive impact on serious problems undercutting addiction treatment efficacy.",2020,"Addiction Severity Index alcohol and drug use scores increased in TAU and decreased in MAP during Follow-Up Weeks 13-24 for ERPs, alcohol: b = -0.08, SE = 0.03, t(47) =","['Mentorship for Addiction Problems (MAP', '65 participants (17 later recovery participants [LRPs] and 48 early recovery participants [ERPs]) with substance use disorders']","['MAP + Treatment as Usual (TAU) or TAU alone', 'MAP']","['Addiction Severity Index alcohol', 'Behavioral and biological measures']","[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",65.0,0.0528507,"Addiction Severity Index alcohol and drug use scores increased in TAU and decreased in MAP during Follow-Up Weeks 13-24 for ERPs, alcohol: b = -0.08, SE = 0.03, t(47) =","[{'ForeName': 'Kathlene', 'Initials': 'K', 'LastName': 'Tracy', 'Affiliation': 'Psychosocial Division, Addiction Institute Mount Sinai (AIMS), Laboratory of Psychosocial Processes in Addiction, Icahn School of Medicine at Mount Sinai, Department of Psychiatry, New York, New York.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Wachtel', 'Affiliation': 'Psychosocial Division, Addiction Institute Mount Sinai (AIMS), Laboratory of Psychosocial Processes in Addiction, Icahn School of Medicine at Mount Sinai, Department of Psychiatry, New York, New York.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Goldmann', 'Affiliation': 'College of Global Public Health, New York University, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nissenfeld', 'Affiliation': 'Division of Alcoholism and Drug Abuse, New York University School of Medicine, Department of Psychiatry, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Division of Alcoholism and Drug Abuse, New York University School of Medicine, Department of Psychiatry, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Galanter', 'Affiliation': 'Division of Alcoholism and Drug Abuse, New York University School of Medicine, Department of Psychiatry, New York, New York.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Ball', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, New Haven, Connecticut.'}]",Journal of studies on alcohol and drugs,[]
3040,33028548,"SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis.","INTRODUCTION


Intermittent neurogenic claudication (INC) is often caused by lumbar spinal stenosis (LSS). Laminectomy is considered a frequently used surgical technique for LSS. Previous studies have shown that laminectomy can potentially cause lumbar instability. Less invasive techniques, preserving midline structures including the bilateral small size interarcuair decompression, are currently applied. Due to lack of evidence and consensus, surgeons have to rely on their training and own experiences to choose the best surgical techniques for their patients. Hence, an observer and patient blinded multicentre, randomised controlled trial was designed to determine the effectiveness and cost-effectiveness of bilateral interarcuair decompression versus laminectomy for LSS.
METHODS AND ANALYSIS


174 patients above 40 years with at least 12 weeks of INC will be recruited. Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS. Patients will be randomised to laminectomy or bilateral interarcuair decompression. The primary outcome is functional status measured with the Roland-Morris Disability Questionnaire at 12 months. Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination. Outcome measurement moments will be scheduled at 3 and 6 weeks, and at 3, 6, 12, 18, 24, 36 and 48 months after surgery. Physical examination will be performed at 6 weeks, and 12, 24 and 48 months. An economic evaluation will be performed and questionnaires will be used to collect cost data.
ETHICS AND DISSEMINATION


The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam approved this study (NL.65826.078.18). The results will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT03480893).
IRB APPROVAL STATUS


MEC-2018-093.",2020,"Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination.","['Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS', 'patients with intermittent neurogenic claudication caused by lumbar spinal stenosis', '174 patients above 40 years with at least 12 weeks of INC will be recruited']","['bilateral interarcuair decompression versus laminectomy', 'laminectomy', 'interarcuair decompression versus extended decompression', 'laminectomy or bilateral interarcuair decompression']","['effectiveness and cost-effectiveness', 'functional status measured with the Roland-Morris Disability Questionnaire', 'pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",174.0,0.167345,"Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Arjun Sharma', 'Affiliation': 'Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Pravesh S', 'Initials': 'PS', 'LastName': 'Gadjradj', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Wilco C', 'Initials': 'WC', 'LastName': 'Peul', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter A', 'Initials': 'WA', 'LastName': 'Moojen', 'Affiliation': 'Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center and The Hague Medical Center, Leiden, The Netherlands, Leiden, The Netherlands.'}, {'ForeName': 'Biswadjiet S', 'Initials': 'BS', 'LastName': 'Harhangi', 'Affiliation': 'Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands b.s.harhangi@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-036818']
3041,33028559,Hydrocolloid dressing as a prophylactic use for hand-foot skin reaction induced by multitargeted kinase inhibitors: protocol of a phase 3 randomised self-controlled study.,"INTRODUCTION


Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement. Hydrocolloid dressing is a type of wound dressing often used for wounds such as decubitus ulcers. The purpose of this study is to verify the usefulness of application of hydrocolloid dressings as prophylaxis against development of hand-foot syndrome induced by multikinase inhibitors by comparing the effects of this dressing and standard supportive care (moisturising care alone) within the same individuals.
METHODS


This study is a phase 3 randomised, self-controlled study to compare prophylactic moisturising care with or without hydrocolloid dressing for hand-foot syndrome induced by multikinase inhibitors. Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive regorafenib or sorafenib therapy are eligible for enrolment.Supportive care for hand-foot syndrome will consist of basic moisturising care with or without hydrocolloid dressing. If hand-foot syndrome occurs, a steroid ointment will be applied two times per day at the affected sites. The primary endpoint is an incidence rate of grade 2 or more severe hand-foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0. Grading of hand-foot syndrome will be performed by central review using photographs taken weekly by blinded trained physicians. The ethical approval was obtained from National Cancer Center Hospital. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conference.
DISCUSSION


If the positive results are found in this study, it is shown that hydrocolloid dressing is effective not only as a symptom management but also as a prevention in hand-foot syndrome induced by multikinase.
TRIAL STATUS


The enrolment was started in January 2019, and planned to closed in January 2021. As of February 2020, 26 patients enrolled in this study.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trial Registry (UMIN000034853).
PROTOCOL VERSION


V.1.4, 9 January 2020.",2020,"Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement.","['for hand-foot syndrome induced by multikinase inhibitors', 'VERSION\n\n\nV.1.4, 9 January 2020', 'February 2020, 26 patients enrolled in this study', 'Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive']","['Hydrocolloid dressing', 'hydrocolloid dressing', 'regorafenib or sorafenib therapy', 'hydrocolloid dressings', 'prophylactic moisturising care with or without hydrocolloid dressing']",['incidence rate of grade 2 or more severe hand-foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0'],"[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0854750', 'cui_str': 'Colorectal cancer recurrent'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}]",26.0,0.0356922,"Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand-foot syndrome induced by multikinase inhibitors, there is still room for improvement.","[{'ForeName': 'Sadamoto', 'Initials': 'S', 'LastName': 'Zenda', 'Affiliation': 'Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan szenda@east.ncc.go.jp.'}, {'ForeName': 'Asako', 'Initials': 'A', 'LastName': 'Ryu', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Department of Palliative Medicine, Teikyo University School of Medicine Graduate School of Medicine, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Mashiko', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Chigusa', 'Initials': 'C', 'LastName': 'Morizane', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hanai', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, & Behavioral and Survivorship Research Group, Center for Public Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Fukuko', 'Initials': 'F', 'LastName': 'Oshiba', 'Affiliation': 'Department of Nursing, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-038276']
3042,33028560,"Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD).","INTRODUCTION


Inflammatory bowel diseases (IBD) are among the most common chronic illnesses diagnosed in childhood. Transition from paediatric to adult care is a crucial phase. The implementation of joint visits during the transition period in IBD is widely recommended, however, strong evidence supporting their benefit is still missing. In this trial, we aim to prove the superiority of joint visits compared with usual care in improving transition outcomes of adolescents with IBD.
METHODS AND ANALYSIS


This is a randomised controlled two-arm multicentre trial. A minimum of 160 adolescents with IBD aged between 16.75 and 17 years will be recruited from Hungarian tertiary IBD centres. After randomisation, eligible subjects in the intervention arm attend a total of four joint visits with adult and paediatric gastroenterologist between the ages of 17 and 18. In the control arm, adolescents meet only the paediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologist regarding the patient's treatment plan. Patients in both groups receive the same training and education, the only determinative difference between the two arms is the presence of the adult gastroenterologist at the joint visits. Data will be collected at inclusion, at transfer and 12 months post-transfer. Primary outcome is the change in health-related quality of life measured with the IMPACT-III questionnaire at 1 year after transfer. Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction. To compare the results of the two patient groups, two-sample T-test and Mann-Whitney test will be applied.
ETHICS AND DISSEMINATION


The Scientific and Research Ethics Committee of the Hungarian Medical Research Council approved this study (50457-2/2019/EKU). Findings will be disseminated at conferences and in medical journals.
TRIAL REGISTRATION NUMBER


NCT04290156.",2020,"Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction.","['160 adolescents with IBD aged between 16.75 and 17 years will be recruited from Hungarian tertiary IBD centres', 'eligible subjects in the intervention arm attend a total of four joint visits with adult and paediatric gastroenterologist between the ages of 17 and 18', 'adolescents with IBD', 'adolescents with inflammatory bowel diseases']","['joint transition visits', 'usual care']","[""number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction"", 'quality of life', 'change in health-related quality of life measured with the IMPACT-III questionnaire at 1\u2009year after transfer']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020173', 'cui_str': 'Hungarian language'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0586844', 'cui_str': 'Pediatric gastroenterologist'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.174666,"Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction.","[{'ForeName': 'Adrienn', 'Initials': 'A', 'LastName': 'Erős', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Dohos', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Veres', 'Affiliation': 'First Department of Pediatrics, University of Debrecen, Hungary, Debrecen, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Tárnok', 'Affiliation': 'Department of Pediatrics, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Áron', 'Initials': 'Á', 'LastName': 'Vincze', 'Affiliation': 'First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary, Pécs, Hungary.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Tészás', 'Affiliation': 'Department of Pediatrics, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Zádori', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Noémi', 'Initials': 'N', 'LastName': 'Gede', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Hegyi', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Sarlós', 'Affiliation': 'Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary sarlosp@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038410']
3043,33028566,"Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) - a randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants.","INTRODUCTION


Chronic lung disease of prematurity (CLD), also known as bronchopulmonary dysplasia (BPD), is a cause of significant respiratory morbidity in childhood and beyond. Coupled with lung immaturity, infections (especially by  Ureaplasma  spp) are implicated in the pathogenesis of CLD through promotion of pulmonary inflammation. Azithromycin, which is a highly effective against  Ureaplasma  spp also has potent anti-inflammatory properties. Thus, azithromycin therapy may improve respiratory outcomes by targeting infective and inflammatory pathways. Previous trials using macrolides have not been sufficiently powered to definitively assess CLD rates. To address this, the azithromycin therapy for chronic lung disease of prematurity (AZTEC) trial aims to determine if a 10-day early course of intravenous azithromycin improves rates of survival without CLD when compared with placebo with an appropriately powered study.
METHODS AND ANALYSIS


796 infants born at less than 30 weeks' gestational age who require at least 2 hours of continuous respiratory support within the first 72 hours following birth are being enrolled by neonatal units in the UK. They are being randomised to receive a double-blind, once daily dose of intravenous azithromycin (20 mg/kg for 3 days, followed by 10 mg/kg for a further 7 days), or placebo. CLD is being assessed at 36 weeks' PMA. Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated. Secondary outcomes include necrotising enterocolitis, intraventricular/cerebral haemorrhage, retinopathy of prematurity and nosocomial infections, development of antibiotic resistance and adverse reactions will be monitored.
ETHICS AND DISSEMINATION


Ethics permission has been granted by Wales Research Ethics Committee 2 (Ref 18/WA/0199), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (Clinical Trials Authorisation reference 21323/0050/001-0001). The study is registered on ISRCTN (ISRCTN11650227). The study is overseen by an independent Data Monitoring Committee and an independent Trial Steering Committee. We shall disseminate our findings via national and international peer-reviewed journals, and conferences. A summary of the findings will also be posted on the trial website.",2020,Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated.,"['chronic lung disease of prematurity (AZTEC', ""796 infants born at less than 30 weeks' gestational age who require at least 2 hours of continuous respiratory support within the first 72 hours following birth are being enrolled by neonatal units in the UK"", 'chronic lung disease of prematurity in preterm infants']","['Azithromycin', 'placebo', 'azithromycin', 'azithromycin therapy']","['necrotising enterocolitis, intraventricular/cerebral haemorrhage, retinopathy of prematurity and nosocomial infections, development of antibiotic resistance and adverse reactions', 'rates of survival without CLD']","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0337878', 'cui_str': 'Aztec'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}]",796.0,0.628621,Whether colonisation with  Ureaplasma  spp prior to randomisation modifies the treatment effect of azithromycin compared with placebo will also be investigated.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hubbard', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Child Health, School of Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Kirby', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Turner', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'GOS Institute of Child Health, University College London, London, London, UK.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Marchesi', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Berrington', 'Affiliation': 'Neonatal Intensive Care Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kotecha', 'Affiliation': 'Department of Child Health, School of Medicine, Cardiff University, Cardiff, United Kingdom KotechaS@cardiff.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-041528']
3044,33028585,Infographic. Does foot mobility affect the outcome in the management of patellofemoral pain with foot orthoses versus hip exercises? A randomised clinical trial.,,2020,,[],[],[],[],[],[],,0.116639,,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': 'School of Sport, Ulster University, Belfast, UK.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Andrew Philip', 'Initials': 'AP', 'LastName': 'Claus', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McPoil', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, Colorado, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nee', 'Affiliation': 'School of Physical Therapy, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe University-Bundoora Campus, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Clinical Epidemiology at Cabrini, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill T', 'Initials': 'BT', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia b.vicenzino@uq.edu.au.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103081']
3045,33028588,Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial.,"OBJECTIVE


To evaluate the effect of five years of supervised exercise training compared with recommendations for physical activity on mortality in older adults (70-77 years).
DESIGN


Randomised controlled trial.
SETTING


General population of older adults in Trondheim, Norway.
PARTICIPANTS


1567 of 6966 individuals born between 1936 and 1942.
INTERVENTION


Participants were randomised to two sessions weekly of high intensity interval training at about 90% of peak heart rate (HIIT, n=400), moderate intensity continuous training at about 70% of peak heart rate (MICT, n=387), or to follow the national guidelines for physical activity (n=780; control group); all for five years.
MAIN OUTCOME MEASURE


All cause mortality. An exploratory hypothesis was that HIIT lowers mortality more than MICT.
RESULTS


Mean age of the 1567 participants (790 women) was 72.8 (SD 2.1) years. Overall, 87.5% of participants reported to have overall good health, with 80% reporting medium or high physical activity levels at baseline. All cause mortality did not differ between the control group and combined MICT and HIIT group. When MICT and HIIT were analysed separately, with the control group as reference (observed mortality of 4.7%), an absolute risk reduction of 1.7 percentage points was observed after HIIT (hazard ratio 0.63, 95% confidence interval 0.33 to 1.20) and an absolute increased risk of 1.2 percentage points after MICT (1.24, 0.73 to 2.10). When HIIT was compared with MICT as reference group an absolute risk reduction of 2.9 percentage points was observed (0.51, 0.25 to 1.02) for all cause mortality. Control participants chose to perform more of their physical activity as HIIT than the physical activity undertaken by participants in the MICT group. This meant that the controls achieved an exercise dose at an intensity between the MICT and HIIT groups.
CONCLUSION


This study suggests that combined MICT and HIIT has no effect on all cause mortality compared with recommended physical activity levels. However, we observed a lower all cause mortality trend after HIIT compared with controls and MICT.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01666340.",2020,All cause mortality did not differ between the control group and combined MICT and HIIT group.,"['older adults (70-77 years', 'General population of older adults in Trondheim, Norway', 'Mean age of the 1567 participants (790 women) was 72.8 (SD 2.1) years', 'older adults-the Generation 100 study', '1567 of 6966 individuals born between 1936 and 1942']","['MICT', 'high intensity interval training at about 90% of peak heart rate (HIIT, n=400), moderate intensity continuous training at about 70% of peak heart rate (MICT, n=387), or to follow the national guidelines for physical activity', 'supervised exercise training', 'exercise training']","['cause mortality', 'All cause mortality', 'physical activity levels', 'absolute risk reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",6966.0,0.155157,All cause mortality did not differ between the control group and combined MICT and HIIT group.,"[{'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Stensvold', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Hallgeir', 'Initials': 'H', 'LastName': 'Viken', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Sigurd L', 'Initials': 'SL', 'LastName': 'Steinshamn', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Dalen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Asbjørn', 'Initials': 'A', 'LastName': 'Støylen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Loennechen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Line S', 'Initials': 'LS', 'LastName': 'Reitlo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zisko', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Fredrik H', 'Initials': 'FH', 'LastName': 'Bækkerud', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Atefe R', 'Initials': 'AR', 'LastName': 'Tari', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Silvana B', 'Initials': 'SB', 'LastName': 'Sandbakk', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Trude', 'Initials': 'T', 'LastName': 'Carlsen', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Ingebrigtsen', 'Affiliation': 'Department of Sociology and Political Science, Faculty of Social Sciences and Technology Management, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Erney', 'Initials': 'E', 'LastName': 'Mattsson', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Department of Sports Medicine, The Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Fiatarone Singh', 'Affiliation': 'Exercise Health and Performance Faculty Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Science, University of Queensland, Queensland, Australia.'}, {'ForeName': 'Eirik', 'Initials': 'E', 'LastName': 'Skogvoll', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Lars J', 'Initials': 'LJ', 'LastName': 'Vatten', 'Affiliation': 'Department of Public Health and General Practice, Faculty of Medicine, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jorunn L', 'Initials': 'JL', 'LastName': 'Helbostad', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Rognmo', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Wisløff', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Post Box 8905, 7491 Trondheim, Norway ulrik.wisloff@ntnu.no.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3485']
3046,33029163,"Pain Relief during Oocyte Retrieval by Transcutaneous Electrical Acupoint Stimulation: A Single-Blinded, Randomized, Controlled Multicenter Trial.","Acupuncture has pain-relief effects, but no data were available on the use of transcutaneous electric acupoint stimulation (TEAS) in pain relief during oocyte retrieval. This study was designed to examine the effect of TEAS for pain relief in women undergoing transvaginal ultrasound-guided oocyte aspiration. This single-blinded, multicenter, randomized controlled trial was performed in China between May 2013 and May 2015. The subjects were randomized to mock TEAS and TEAS. TEAS or mock TEAS was administered 30 min before oocyte retrieval until the end of the operation. The primary and secondary endpoints were the pain measured using the visual analog scale (VAS) within 1 min and 1 hour after oocyte retrieval, respectively. Serum  β -endorphin levels were tested in the first 50 patients/group. 390 women were undergoing oocyte retrieval. Pain levels evaluated using VAS within 1 min (18.6 ± 1.3 vs. 24.4 ± 1.7,  P  < 0.01) and 1 h after oocyte aspiration (4.6 ± 0.7 vs. 6.8 ± 0.8,  P  < 0.05) were lower in the TEAS group than in the mock TEAS group. Nausea assessment revealed a significantly lower VAS score in the TEAS group within 1 min (1.2 ± 0.4 vs. 2.9 ± 0.7,  P  < 0.033). Serum  β -endorphin levels were significantly higher in the TEAS group than in the mock TEAS group (11.4 ± 0.5 vs. 9.1 ± 0.4,  P  < 0.001) after retrieval. Serum  β -endorphin levels were higher in the TEAS group after the procedure than baseline (11.4 ± 0.5 vs. 9.1 ± 0.3,  P  < 0.001). Oocyte retrieval causes pain and discomfort, but TEAS is effective and safe for suppressing the pain and alleviating nausea associated with the operation.",2020,"Pain levels evaluated using VAS within 1 min (18.6 ± 1.3 vs. 24.4 ± 1.7,  P  < 0.01) and 1 h after oocyte aspiration (4.6 ± 0.7 vs. 6.8 ± 0.8,  P  < 0.05) were lower in the TEAS group than in the mock TEAS group.","['390 women were undergoing oocyte retrieval', 'China between May 2013 and May 2015', 'women undergoing transvaginal ultrasound-guided oocyte aspiration']","['Acupuncture', 'TEAS', 'Transcutaneous Electrical Acupoint Stimulation', 'mock TEAS and TEAS', 'transcutaneous electric acupoint stimulation (TEAS', 'TEAS or mock TEAS']","['Pain Relief', 'endorphin levels', 'Serum', 'Pain levels', 'VAS score', 'pain measured using the visual analog scale (VAS', 'pain-relief effects', 'pain relief', 'pain and alleviating nausea', 'Nausea assessment', 'Serum  β -endorphin levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1955885', 'cui_str': 'Oocyte Aspiration'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",390.0,0.173894,"Pain levels evaluated using VAS within 1 min (18.6 ± 1.3 vs. 24.4 ± 1.7,  P  < 0.01) and 1 h after oocyte aspiration (4.6 ± 0.7 vs. 6.8 ± 0.8,  P  < 0.05) were lower in the TEAS group than in the mock TEAS group.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': ""Center of Reproductive Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience Research Institute, Peking University, Department of Neurobiology, School of Basic Medical Sciences, Peking University Health Science Center, Key Lab for Neuroscience, The Ministry of Education, The Ministry of Health, Beijing, China.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Center of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Center of Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Key Laboratory of Assisted Reproduction, Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Ministry of Education, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Kong', 'Affiliation': ""Center of Reproductive Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Center of Reproductive Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Center of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Beijing, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center of Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Key Laboratory of Assisted Reproduction, Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Ministry of Education, Beijing, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Bu', 'Affiliation': ""Center of Reproductive Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yonglian', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Center of Reproductive Medicine, Beijing Obstetrics and Gynecology Hospital, Beijing, China.'}, {'ForeName': 'Songping', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Wuxi Shen Ping Xin Tai Medical Technology Co., Ltd., Wuxi, China.'}, {'ForeName': 'Jisheng', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Neuroscience Research Institute, Peking University, Department of Neurobiology, School of Basic Medical Sciences, Peking University Health Science Center, Key Lab for Neuroscience, The Ministry of Education, The Ministry of Health, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Jinan, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3285648']
3047,33029166,Effect of Catgut Embedment in Du Meridian Acupoint on Mental and Psychological Conditions of Patients with Gastroesophageal Reflux Disease.,"Objective


To observe the influence of the catgut-embedding method in Du Meridian acupoint on the mental and psychological state of patients with gastroesophageal reflux disease (GERD) and analyze its possible mechanism.
Methods


According to the random number table, 60 patients with GERD were randomly divided into groups of acupoint catgut embedding and Western medicine, 30 cases in each group. The acupoint group was given catgut embedment in the positive reaction points along the Du Meridian, while the Western medicine group received lansoprazole tablet. They were both treated for six weeks. Scores of Gastroesophageal Reflux Disease Questionnaire (GerdQ), Zung's Self-Rating Anxiety Scale (SAS), Zung's Self-Rating Depression Scale (SDS), and Health-Related Quality of Life Scale for GERD (GERD-HRQL) were measured before and after treatment to analyze and evaluate the differences of symptom scores and mental and psychological conditions between the two groups.
Results


(1) The scores of GerdQ, GERD-HRQL, SAS, and SDS in the two groups both significantly decreased after treatment ( P  < 0.05), and those of the acupoint group were much lower than the Western medicine group ( P  < 0.05). (2) The total effective rate was 90.00% in the acupoint group and 53.33% in the Western medicine group, with a statistically significant difference ( P  < 0.05). (3) The correlation coefficients  r  between the GerdQ score and scores of SAS and SDS were 0.563 and 0.322, respectively, and those between the GERD-HRQL score and scores of SAS and SDS were, respectively, 0.506 and 0.435.
Conclusion


(1) The main symptoms of GERD patients, such as acid reflux and heartburn, mental and psychological condition, and quality of life, were all improved in the two groups, but the efficacy in the acupoint group is superior to that of the Western medicine group. (2) The clinical symptoms and scores of patients' quality of life are positively correlated with the degree of their anxiety and depression. (3) The acupoint catgut-embedding method can effectively regulate the anxiety and depressive symptoms of patients, which complements the efficacy of proton-pump inhibitors and benefits a wider range of population.",2020,"r  between the GerdQ score and scores of SAS and SDS were 0.563 and 0.322, respectively, and those between the GERD-HRQL score and scores of SAS and SDS were, respectively, 0.506 and 0.435.
","['patients with gastroesophageal reflux disease (GERD', 'Patients with Gastroesophageal Reflux Disease', '60 patients with GERD']","['acupoint catgut embedding and Western medicine', 'lansoprazole tablet', 'Catgut Embedment', 'catgut-embedding method in Du Meridian acupoint']","['GERD-HRQL score and scores of SAS and SDS', 'total effective rate', ""Scores of Gastroesophageal Reflux Disease Questionnaire (GerdQ), Zung's Self-Rating Anxiety Scale (SAS), Zung's Self-Rating Depression Scale (SDS), and Health-Related Quality of Life Scale for GERD"", 'symptom scores and mental and psychological conditions', 'scores of GerdQ, GERD-HRQL, SAS, and SDS', 'GerdQ score and scores of SAS and SDS', 'acid reflux and heartburn, mental and psychological condition, and quality of life', 'Mental and Psychological Conditions', ""clinical symptoms and scores of patients' quality of life""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",60.0,0.0169303,"r  between the GerdQ score and scores of SAS and SDS were 0.563 and 0.322, respectively, and those between the GERD-HRQL score and scores of SAS and SDS were, respectively, 0.506 and 0.435.
","[{'ForeName': 'Zhengjie', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': ""Department of Rehabilitation Medicine, Third Affiliated Hospital of Soochow University & Changzhou First People's Hospital, Changzhou 213003, Jiangsu, China.""}, {'ForeName': 'Xuanming', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture, Nanjing Hospital of Chinese Medicine, Affiliated to Nanjing University of Chinese Medicine, Nanjing 210001, Jiangsu, China.'}, {'ForeName': 'Chaoming', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture, Nanjing Hospital of Chinese Medicine, Affiliated to Nanjing University of Chinese Medicine, Nanjing 210001, Jiangsu, China.'}, {'ForeName': 'Lvqun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Jirou', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing 210029, Jiangsu, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5415813']
3048,33029170,Efficacy of Acupoints Dual-Frequency Low-Level Laser Therapy on Knee Osteoarthritis.,"Background


Knee osteoarthritis (OA) presented with knee pain and limitation of mobility is common, and it may become a chronic problem resulting in major loss of function, with related impaired activity of daily living. Current traditional therapy for knee OA includes pharmacological treatment and physiotherapy, but the efficacies are limited. An alternative noninvasive treatment low-level laser therapy (LLLT) applied to acupoints is still contradictory and the efficacy needs to be assessed.
Methods and Materials


We conduct the randomized double-blind control study to investigate the efficacy of a dual-frequency LLLT (combines red light (780 nm) and near-infrared light (830 nm)) in patients suffering knee OA. Participates were randomly assigned into active laser therapy (ALT) and placebo laser therapy (PLT) groups. Subjects in the ALT group were separately treated by laser apparatus at the three acupoints (SP9, SP10, and EX-LE2) on their knee joints under continuous radiation for 15 min at the maximum intensity, three times per week for four weeks. The PLT group used laser apparatus of the same model according to similar procedures without laser light emission. Outcome Measurements including visual analog scale (VAS), pain pressure threshold (PPT), and Lequesne index were used.
Results


A total of 30 subjects with two-sided knee OA in both groups completed the experiment. Statistically significant decreases were observed in the Lequesne index (5.27 ± 3.26 vs. 10.83 ± 3.83), conscious VAS 4 weeks after treatment (moving: 2.87 ± 1.13 vs. 5.67 ± 1.72; resting: 0.33 ± 0.62 vs. 2.67 ± 1.29), and the increase was noted in PPT (21.23 ± 1.82 kg vs. 13.02 ± 1.46 kg) in the ALT group compared with the PLT group.
Conclusion


It appears that the knee OA pain and disability can be decreased after a dual-frequency LLLT applied to acupoints (SP9, SP10, and EX-LE2). The clinical efficacy of LLLT is highly related to the therapeutic settings of the laser apparatus; hence, more clinical trials with diffident parameter settings are needed to be further clarified.",2020,"Statistically significant decreases were observed in the Lequesne index (5.27 ± 3.26 vs. 10.83 ± 3.83), conscious VAS 4 weeks after treatment (moving: 2.87 ± 1.13 vs. 5.67 ± 1.72; resting: 0.33 ± 0.62 vs. 2.67 ± 1.29), and the increase was noted in PPT (21.23 ± 1.82 kg vs. 13.02 ± 1.46 kg) in the ALT group compared with the PLT group.
","['patients suffering knee OA', '30 subjects with two-sided knee OA', 'Knee Osteoarthritis']","['LLLT', 'laser apparatus at the three acupoints (SP9, SP10, and EX-LE2', 'Acupoints Dual-Frequency Low-Level Laser Therapy', 'alternative noninvasive treatment low-level laser therapy (LLLT', 'PLT', 'dual-frequency LLLT (combines red light (780\u2009nm) and near-infrared light (830\u2009nm', 'active laser therapy (ALT) and placebo laser therapy (PLT']","['knee OA pain and disability', 'visual analog scale (VAS), pain pressure threshold (PPT), and Lequesne index', 'Lequesne index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0450551', 'cui_str': 'SP9'}, {'cui': 'C0450552', 'cui_str': 'SP10'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C4517889', 'cui_str': '830'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}]",30.0,0.0363172,"Statistically significant decreases were observed in the Lequesne index (5.27 ± 3.26 vs. 10.83 ± 3.83), conscious VAS 4 weeks after treatment (moving: 2.87 ± 1.13 vs. 5.67 ± 1.72; resting: 0.33 ± 0.62 vs. 2.67 ± 1.29), and the increase was noted in PPT (21.23 ± 1.82 kg vs. 13.02 ± 1.46 kg) in the ALT group compared with the PLT group.
","[{'ForeName': 'Fang-Yin', 'Initials': 'FY', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung 40432, Taiwan.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung 40432, Taiwan.'}, {'ForeName': 'Sui-Foon', 'Initials': 'SF', 'LastName': 'Lo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung 40432, Taiwan.'}, {'ForeName': 'Chun-Ching', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation, New Bodhi Hospital, Taichung 41222, Taiwan.'}, {'ForeName': 'Wen-Yen', 'Initials': 'WY', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung 40432, Taiwan.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung 40432, Taiwan.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6979105']
3049,33029178,Ameliorating Effects of Transcutaneous Electrical Acustimulation at Neiguan (PC6) and Zusanli (ST36) Acupoints Combined with Adaptive Biofeedback Training on Functional Outlet Obstruction Constipation.,"Background


Stimulant laxatives are still considered the most common treatment for functional outlet obstruction constipation (FOOC). However, the effectiveness of laxatives is unsatisfactory, and the long-term use of laxatives may cause certain adverse events. With this in mind, it is, however, paramount that novel complementary treatment(s) and/or other forms of alternative medicine are adequately investigated.
Aims


The study aims to explore the effects and potential mechanism(s) of transcutaneous electrical acustimulation (TEA) combined with adaptive biofeedback training (ABT) on FOOC.
Methods


A total of forty-five patients with FOOC were recruited and were randomly assigned to receive either Macrogol 4000 Powder (MAC, 10 g bid) (group A,  n  = 15) only, ABT + MAC + Sham-TEA (group B,  n  = 15), or TEA + ABT + MAC (group C,  n  = 15) in a six-week study. Individual patients' constipation-symptoms (PAC-SYM) and constipation-quality of life (PAC-QOL) were both assessed and scored. Serum acetylcholine (Ach) and nitric oxide (NO) were measured from drawn blood samples while individual patients' heart rate variability (HRV) was calculated at baseline and after each corresponding therapy. Anorectal manometry and balloon expulsion test were both performed before and after treatment.
Results


Firstly, participants in group C had significantly lower scores of PAC-SYM, PAC-QOL, and a decreased anal defecating pressure (ADP) as compared to participants in group B (all  p  < 0.050). These results, however, suggest the TEAs effect. Secondly, the low-frequency band (LF)/(LF + HF) ratio in groups B and C were decreased as compared to group A ( p =0.037,  p =0.010, respectively) regarding HRV. On the other hand, the high-frequency band (HF)/(LF + HF) ratio in groups B and C showed an opposite outcome. Finally, the serum Ach in groups B and C was significantly higher as compared to group A ( p =0.023,  p =0.012, respectively). Of significant importance, the serum NO in groups B and C were notably low as compared to group A ( p =0.001,  p  < 0.001, respectively).
Conclusions


TEA, combined with ABT, effectively improves constipation symptoms as well as QOL in FOOC patients. It is, however, achieved by decreasing ADP, which mechanisms are mediated via the autonomic and enteric mechanisms.",2020,"Finally, the serum Ach in groups B and C was significantly higher as compared to group A ( p =0.023,  p =0.012, respectively).",['A total of forty-five patients with FOOC'],"['Transcutaneous Electrical Acustimulation at Neiguan (PC6) and Zusanli (ST36) Acupoints Combined with Adaptive Biofeedback Training', 'Macrogol 4000 Powder (MAC, 10', 'transcutaneous electrical acustimulation (TEA) combined with adaptive biofeedback training (ABT', 'TEA', 'TEA\u2009+\u2009ABT\u2009+\u2009MAC']","[""Individual patients' constipation-symptoms (PAC-SYM) and constipation-quality of life (PAC-QOL"", 'heart rate variability (HRV', 'constipation symptoms', 'scores of PAC-SYM, PAC-QOL, and a decreased anal defecating pressure (ADP', 'low-frequency band (LF)/(LF\u2009+\u2009HF) ratio', 'Anorectal manometry and balloon expulsion test', 'Functional Outlet Obstruction Constipation', 'Serum acetylcholine (Ach) and nitric oxide (NO']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C2584913', 'cui_str': 'Balloon expulsion test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",45.0,0.0404687,"Finally, the serum Ach in groups B and C was significantly higher as compared to group A ( p =0.023,  p =0.012, respectively).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Affiliated Provincial Hospital, Anhui Medical University, Hefei, Anhui 230001, China.'}, {'ForeName': 'Hulin', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Affiliated Provincial Hospital, Anhui Medical University, Hefei, Anhui 230001, China.'}, {'ForeName': 'Dewei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Affiliated Provincial Hospital, Anhui Medical University, Hefei, Anhui 230001, China.'}, {'ForeName': 'Ruiling', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Department of Gastroenterology, Affiliated Provincial Hospital, Anhui Medical University, Hefei, Anhui 230001, China.'}, {'ForeName': 'Chaolan', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'South District of Endoscopic Center, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'South District of Endoscopic Center, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Gastroenterology, Affiliated Provincial Hospital, Anhui Medical University, Hefei, Anhui 230001, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8798974']
3050,33031265,Erector spinae plane block for postoperative pain and recovery in hepatectomy: A randomized controlled trial.,"BACKGROUND


The randomized controlled study aimed to examine the efficacy of preoperative ultrasound-guided erector spinae plane (ESP) block combined with ropivacaine in patients undergoing hepatectomy.
METHODS


A total of 60 patients were randomized to ESP block group receiving ropivacaine (Group A) and control group (Group B), n = 30 per group. Visual analog scale (VAS) was recorded in both the groups during rest and movement at the various time intervals. Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
RESULTS


No significant differences were observed in the demographic characteristics. For group A, when compared to group B, VAS scores during rest and movement within post-operative 24 hours were decreased, the time of first anus exhaust and ambulation were earlier, analgesic consumption and the incidence of postoperative nausea, vomiting and headache was reduced, the duration of hospital stay were shorter with longer walk distance.
CONCLUSION


ESP block combined with ropivacaine treatment effectively reduced early postoperative pain and improved recovery after hepatectomy.",2020,"Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
","['60 patients', 'hepatectomy', 'patients undergoing hepatectomy']","['Erector spinae plane block', 'preoperative ultrasound-guided erector spinae plane (ESP) block combined with ropivacaine', 'ropivacaine', 'ESP block group receiving ropivacaine']","['early postoperative pain', 'time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay', 'VAS scores', 'duration of hospital stay', 'time of first anus exhaust and ambulation were earlier, analgesic consumption and the incidence of postoperative nausea, vomiting and headache', 'Visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.0733324,"Both the groups were also compared for time to initial anal exhaust, analgesic usage, early postoperative complications and side-effects, walk distance after the operation, time to out-of-bed activity, and duration of hospital stay.
","[{'ForeName': 'Junbao', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, Linyi Central Hospital, Linyi, Shandong, China.'}, {'ForeName': 'Guangmeng', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022251']
3051,33031270,"Contrast-enhanced ultrasound for determining muscular perfusion after oral intake of L-citrulline, L-arginine, and galloylated epicatechines: A study protocol.","INTRODUCTION


The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called ""NO-boosters,"" which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS).
METHODS


This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters.
DISCUSSION


The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.",2020,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","['30-male athletes between 18 and 40 years', 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg', 'healthy male athletes']","['muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS', 'nitric oxide', 'Contrast-enhanced ultrasound', 'placebo']",['muscular perfusion'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.227635,"The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bürkle', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Neide', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Tsitlakidis', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Ultrasound Center, HTRG - Heidelberg Trauma Research Group, Heidelberg University Hospital.'}]",Medicine,['10.1097/MD.0000000000022318']
3052,33031287,Clinical application of accelerated rehabilitation surgery in elderly patients with colorectal cancer.,"BACKGROUND


Gastrointestinal malignant tumors are the most common malignant tumors in elderly people in China, resulting in an increasing trend of morbidity and mortality. We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
METHODS


This is a single center, non-random, parallel-controlled clinical trial, 60 patients aged ≥65 years will be randomized for Case group ERAS and Control group (routine care).
RESULTS


This study will help to evaluate the clinical feasibility, safety and effectiveness of ERAS in elderly patients undergoing colorectal resection compared with routine care.
PROTOCOL REGISTRATION NUMBER


ChiCTR2000034984.",2020,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","['elderly patients with colorectal cancer', 'elderly patients after colorectal cancer surgery', 'elderly patients undergoing colorectal resection compared with routine care', '60 patients aged ≥65 years']","['ERAS', 'Routine care', 'enhanced recovery after surgery (ERAS', 'accelerated rehabilitation surgery']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],60.0,0.156973,"We conducted a non-randomized controlled trial to compare the effect of enhanced recovery after surgery (ERAS) versus Routine care on clinical outcomes in elderly patients after colorectal cancer surgery.
","[{'ForeName': 'Linxia', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery (Gastrointestinal Surgery), Hospital of Southwest Medical University, Jiangyang District, Luzhou City, Sichuan Province, China.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Meixuan', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xunlian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022503']
3053,33031293,The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial.,"BACKGROUND


There is no consensus in existing literature on the pulse power, application time, frequency and the dose of energy of laser therapy for the patients. Therefore, we conducted this research for the assessment of safety and efficiency of ultrasound and high-intensity laser therapy (HILT) in the lumbar disc herniation (LDH) patients.
METHODS


Our present research was approved by the institutional review board in the West China-Guangan Hospital. All the participants would acquire the written informed consent. From December 2020 to December 2021, we will conduct a prospective evaluation via a senior surgeon for 1 hundred LDH patients who plan to undergo the conservative treatment at our hospital. In this research, the inclusion criteria contained: the patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities; and the patients with sufficient psychological ability to understand and then answer the questions raised in assessment scale. The participants were randomly divided into the control group or HILT group after performing the examination of baseline. The main outcome was the pain score of visual analog scale. The other results contained the adverse effects, back range of motion as well as functional scores.
CONCLUSIONS


We assumed that the HILT is as effective as the ultrasound therapy in treating pain for LDH.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5975).",2020,"The other results contained the adverse effects, back range of motion as well as functional scores.
","['1 hundred LDH patients who plan to undergo the conservative treatment at our hospital', 'lumbar disc herniation (LDH) patients', 'patients with lumbar disc herniation', 'patients with lumbar disc herniation diagnosed by lumbar MRI; the patients with no history of trauma or congenital abnormalities']","['high intensity laser therapy', 'ultrasound and high-intensity laser therapy (HILT', 'HILT', 'placebo', 'control group or HILT']","['adverse effects, back range of motion as well as functional scores', 'pain score of visual analog scale']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0616658,"The other results contained the adverse effects, back range of motion as well as functional scores.
","[{'ForeName': 'Youyi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Medicine, Nanchang University, Jiangxi.'}, {'ForeName': 'Daxin', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, West China-Guangan Hospital, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022520']
3054,33031472,Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.,"AIM


To investigate the cost-effectiveness of Volar Locking Plate (VLP) compared to External Fixation (EF) for unstable dorsally displaced distal radius fractures in a 3-year perspective.
METHODS


During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture were randomised to VLP or EF. Primary outcome was the incremental cost-effectiveness ratio (ICER) for VLP compared with EF. Data regarding health effects (Quality-adjusted life years, QALYs) was prospectively collected during the trial period until 3 years after surgery. Cost data was collected retrospectively for the same time period and included direct and indirect costs (production loss).
RESULTS


One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis. At one year, the VLP group had a mean incremental cost of 878 euros and a gain of 0.020 QALYs compared with the EF group, rendering an ICER of 43 900 euros per QALY. At three years, the VLP group had a mean incremental cost of 1 082 euros and a negative incremental effect of -0.005 QALYs compared to the EF group, which means that VLP was dominated by EF. The probability that VLP was cost-effective compared to EF at three years, was lower than 50% independent of the willingness to pay per QALY.
CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF. Our results indicate that it is uncertain if VLP is a cost-effective treatment of unstable distal radius fractures compared to EF.",2020,"CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF.","['One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis', 'During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture']","['Volar locking plate versus external fixation', 'VLP or EF', 'Volar Locking Plate (VLP', 'VLP fixation', 'External Fixation (EF']","['direct and indirect costs (production loss', 'mean incremental cost', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0428792,"CONCLUSION


Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF.","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Saving', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Heintz', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Enocson', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mellstrand Navarro', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240377']
3055,33031491,Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis.,"Importance


The outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.
Objective


To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.
Design, Setting, and Participants


The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.
Interventions


Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.
Main Outcomes and Measures


The prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.
Results


A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.
Conclusions and Relevance


Transcatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.
Trial Registration


ClinicalTrials.gov Identifier: NCT03635424.",2020,"The device success rate was 95.3% (95% CI, 90.5%-98.1%).","['150 patients underwent an attempted implant', 'Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019', 'patients with bicuspid aortic stenosis at low surgical risk', 'Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement', 'mean age of 70.3 (5.5) years, 48.0% female (n\u2009=\u200972), and a mean Society of Thoracic Surgeons score of 1.4 (0.6', 'low-surgical risk patients with bicuspid aortic valve stenosis', 'Most patients (136; 90.7%) had Sievers type', 'low-risk patients with bicuspid aortic valve stenosis', 'Low-risk Patients With Bicuspid Aortic Valve Stenosis']","['implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements', 'TAVR', 'Transcatheter Aortic Valve Replacement', 'Transcatheter aortic valve replacement', 'transcatheter aortic valve replacement (TAVR']","['procedural safety, efficacy', 'incidence of all-cause mortality or disabling stroke', 'mean (SD) AV gradient', 'device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure', 'device success rate', 'mild paravalvular leak']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149630', 'cui_str': 'Bicuspid aortic valve'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0923870', 'cui_str': 'Anatomical location (property)'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C1709508', 'cui_str': 'Paravalvular leak'}]",150.0,0.0773092,"The device success rate was 95.3% (95% CI, 90.5%-98.1%).","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Forrest', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Ramlawi', 'Affiliation': 'Department of Cardiothoracic Surgery and Cardiology, Valley Health System, Winchester, Virginia.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Zahr', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Oregon Health and Science University, Portland.'}, {'ForeName': 'Howard K', 'Initials': 'HK', 'LastName': 'Song', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Oregon Health and Science University, Portland.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Chetcuti', 'Affiliation': 'Departments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor.'}, {'ForeName': 'Hector I', 'Initials': 'HI', 'LastName': 'Michelena', 'Affiliation': 'Division of Cardiovascular Ultrasound, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Abeel A', 'Initials': 'AA', 'LastName': 'Mangi', 'Affiliation': 'Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Skiles', 'Affiliation': 'Department of Cardiothoracic Surgery and Cardiology, Valley Health System, Winchester, Virginia.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Statistics, Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Departments of Interventional Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Institute, Houston, Texas.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4738']
3056,33031520,Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes in Alveolar Ridge Preservation: A Clinical and Histological Study.,"Alveolar ridge preservation maintains ridge dimensions and bone quality for implant placement. The aim of this randomized controlled clinical study is to compare the use of a human amnion-chorion membrane to a collagen membrane in an exposed-barrier ridge preservation technique.  Furthermore, this study will determine if intentional membrane exposure compromises ridge dimensions and bone vitality.Forty-three patients requiring extraction and delayed implant placement were randomly assigned into either the experimental or control group. Twenty-one participants received human amnion-chorion membrane (test) during ridge preservation while twenty-two participants received the collagen membrane (control). In both groups, demineralized freeze-dried bone allografts were used to graft the socket and primary closure was not achieved.The patients underwent implant placement after an average healing period of 19.5 weeks, and 2.7 X 8-mm core bone specimens were obtained for histomorphometric analyses. The clinical ridge dimensions were measured after extraction and at the time of delayed implant placement. No significant difference was observed in the mean vital bone formation between the experimental (51.72 ± 8.46%) and control (49.96 ± 8.31%; P > 0.05) groups. The bone height and width did not differ, as determined by clinical measurements (P > 0.05). Using either a human amnion-chorion membrane or type 1 bovine collagen as the open barrier did not change healing, compromise ridge dimensions, or affect bone vitality between the two groups.",2020,No significant difference was observed in the mean vital bone formation between the experimental (51.72 ± 8.46%) and control (49.96 ± 8.31%; P > 0.05) groups.,"['Forty-three patients requiring extraction and delayed implant placement', 'Alveolar Ridge Preservation']","['demineralized freeze-dried bone allografts', 'human amnion-chorion membrane (test', 'Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes', 'human amnion-chorion membrane', 'implant placement', 'collagen membrane (control']","['bone vitality', 'clinical ridge dimensions', 'mean vital bone formation', 'bone height and width']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0008503', 'cui_str': 'Chorionic structure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0772448', 'cui_str': 'Bovine collagen'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",,0.0205726,No significant difference was observed in the mean vital bone formation between the experimental (51.72 ± 8.46%) and control (49.96 ± 8.31%; P > 0.05) groups.,"[{'ForeName': 'Samer A', 'Initials': 'SA', 'LastName': 'Faraj', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kutkut', 'Affiliation': 'University of Kentucky College of Dentistry Faculty Restorative Dentistry 800 Rose St UNITED STATES Lexington KY 40536 6465524667 University of Kentucky College of Dentistry.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Villasante-Tezanos', 'Affiliation': ''}, {'ForeName': 'Sarandeep', 'Initials': 'S', 'LastName': 'Huja', 'Affiliation': ''}, {'ForeName': 'Dolphus', 'Initials': 'D', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'Almehmadi', 'Affiliation': ''}, {'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Al-Sabbagh', 'Affiliation': ''}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00335']
3057,33031534,Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial.,"Importance


Statin therapy is underused for many patients who could benefit.
Objective


To evaluate the effect of passive choice and active choice interventions in the electronic health record (EHR) to promote guideline-directed statin therapy.
Design, Setting, and Participants


Three-arm randomized clinical trial with a 6-month preintervention period and 6-month intervention. Randomization conducted at the cardiologist level at 16 cardiology practices in Pennsylvania and New Jersey. The study included 82 cardiologists and 11 693 patients. Data were analyzed between May 8, 2019, and January 9, 2020.
Interventions


In passive choice, cardiologists had to manually access an alert embedded in the EHR to select options to initiate or increase statin therapy. In active choice, an interruptive EHR alert prompted the cardiologist to accept or decline guideline-directed statin therapy. Cardiologists in the control group were informed of the trial but received no other interventions.
Main Outcomes and Measures


Primary outcome was statin therapy at optimal dose based on clinical guidelines. Secondary outcome was statin therapy at any dose.
Results


The sample comprised 11 693 patients with a mean (SD) age of 63.8 (9.1) years; 58% were male (n = 6749 of 11 693), 66% were White (n = 7683 of 11 693), and 24% were Black (n = 2824 of 11 693). The mean (SD) 10-year atherosclerotic cardiovascular disease (ASCVD) risk score was 15.4 (10.0); 68% had an ASVCD clinical diagnosis. Baseline statin prescribing rates at the optimal dose were 40.3% in the control arm, 39.1% in the passive choice arm, and 41.2% in the active choice arm. In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08). In adjusted analyses of the subset of patients with clinical ASCVD, the active choice intervention resulted in a significant increase in statin prescribing at optimal dose relative to control (adjusted difference in percentage points, 3.8; 95% CI, 1.0-6.4; P = .008). No other subset analyses were significant. There were no significant changes in statin prescribing at any dose for either intervention.
Conclusions and Relevance


The passive choice and active choice interventions did not change statin prescribing. In the subgroup of patients with clinical ASCVD, the active choice intervention led to a small increase in statin prescribing at the optimal dose, which could inform the design or targeting of future interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT03271931.",2020,"In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08).","['16 cardiology practices in Pennsylvania and New Jersey', 'many patients who could benefit', '693 patients with a mean (SD) age of 63.8 (9.1) years; 58% were male (n\u2009=\u20096749 of 11\u202f693), 66% were White (n\u2009=\u20097683 of 11\u202f693), and 24% were Black (n\u2009=\u20092824 of 11\u202f693', '82 cardiologists and 11\u202f693 patients']","['Passive Choice and Active Choice Interventions', 'passive choice and active choice interventions']","['change in statin prescribing rates', 'Baseline statin prescribing rates', 'mean (SD) 10-year atherosclerotic cardiovascular disease (ASCVD) risk score', 'statin prescribing']","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",11693.0,0.266019,"In adjusted analyses, the change in statin prescribing rates at optimal dose over time was not significantly different from control for passive choice (adjusted difference in percentage points, 0.2; 95% CI, -2.9 to 2.8; P = .86) or active choice (adjusted difference in percentage points, 2.4; 95% CI, -0.6 to 5.0; P = .08).","[{'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Adusumalli', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Westover', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Jacoby', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'VanZandbergen', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Cavella', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pepe', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Snider', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Penn Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4730']
3058,33031557,Effects of intermittent fasting or calorie restriction on markers of lipid metabolism in human skeletal muscle.,"CONTEXT


Impaired lipid metabolism is linked with obesity-associated insulin resistance, which may be reversed by caloric restriction (CR).
OBJECTIVE


In a secondary analysis of a randomized controlled trial, we compared the effects of intermittent fasting (IF) and CR on markers of lipid metabolism in muscle.
DESIGN


Seventy-six women (BMI 25-40 kg/m2) were randomized to one of three diets for eight weeks and provided with foods at 70% (CR70 and IF70) or 100% (IF100) of energy requirements. IF groups ate breakfast, prior to a 24-hour fast on 3 non-consecutive days per week. On non-fasting days, IF70 ate at 100% and IF100 ate at 145% of energy requirements to achieve the prescribed target. Weight, body composition, insulin sensitivity by clamp, non-esterified fatty acids (NEFA), β-hydroxybutyrate, and markers of lipid metabolism and oxidative stress in muscle by qPCR were measured at baseline and week 8 following a 12-hour overnight fast (all groups) and 24-hour fast (IF groups).
RESULTS


IF70 resulted in greater weight and fat losses and reduced NEFA versus CR70 and IF100 after an overnight fast. IF70 and IF100 induced a greater reduction only in mRNA levels of antioxidant enzymes  GPX1, SOD1 and SOD2 versus CR70. Fasting for 24-hours increased NEFA and β-hydroxybutyrate in IF groups, but impaired insulin sensitivity and increased PLIN5 mRNA levels.
CONCLUSIONS


In comparison to CR, IF did not increase markers of lipid metabolism in muscle, but reduced expression of antioxidant enzymes. However, fasting-induced insulin resistance was detected, alongside increased PLIN5 expression, potentially reflecting transient lipid storage.",2020,"IF70 and IF100 induced a greater reduction only in mRNA levels of antioxidant enzymes  GPX1, SOD1 and SOD2 versus CR70.","['human skeletal muscle', 'Seventy-six women (BMI 25-40\xa0kg/m2']","['intermittent fasting (IF) and CR', 'intermittent fasting or calorie restriction']","['mRNA levels of antioxidant enzymes \xa0GPX1, SOD1 and SOD2 versus CR70', 'weight and fat losses and reduced NEFA versus CR70 and IF100', 'fasting-induced insulin resistance', 'Weight, body composition, insulin sensitivity by clamp, non-esterified fatty acids (NEFA), β-hydroxybutyrate, and markers of lipid metabolism and oxidative stress', 'lipid metabolism', 'insulin sensitivity and increased PLIN5 mRNA levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",76.0,0.0990874,"IF70 and IF100 induced a greater reduction only in mRNA levels of antioxidant enzymes  GPX1, SOD1 and SOD2 versus CR70.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa707']
3059,33031566,"Maternal body mass index and risk of obstetric, maternal, and neonatal outcomes: A cohort study of nulliparous women with spontaneous onset of labor.","INTRODUCTION


This study investigates associations between maternal body mass index (BMI) early in pregnancy and obstetric interventions, maternal and neonatal outcomes.
MATERIAL AND METHODS


This is a cohort study of nulliparous women originally included in a cluster randomized controlled trial carried out at 14 Norwegian obstetric units between 2014 and 2017. The sample included 7189 nulliparous women with a singleton fetus, cephalic presentation and spontaneous onset of labor at term, denoted as group 1 in the Ten-Group Classification System. The women were grouped according to the World Health Organization's BMI classifications: underweight (BMI < 18.5), normal weight (BMI 18.5-24.9), pre-obesity (BMI 25.0-29.9), obesity class I (BMI 30.0-34.9), and obesity classes II and III (BMI ≥ 35.0). We used binary logistic regression to estimate crude and adjusted odds ratios (ORs) of the interventions and outcomes, with associated 95% confidence intervals (CIs), comparing women in different BMI groups to women of normal weight.
RESULTS


We found an increased risk of intrapartum cesarean section in women of obesity class I and obesity classes II and III, with adjusted OR of 1.70 (95% CI: 1.21-2.38) and 2.31 (95% CI: 1.41-3.77), respectively. Women in obesity groups had a gradient of risk of epidural analgesia and use of continuous CTG (including STAN), with adjusted OR of 2.39 (95% CI: 1.69-3.38) and 3.28 (95% CI: 1.97-5.48), respectively. Women in obesity classes II and III had higher risk of amniotomy (adjusted OR = 1.42 [95% CI: 1.02-1.96]), oxytocin augmentation (adjusted OR = 1.54 [95% CI: 1.11-2.15]), obstetric anal sphincter injuries (adjusted OR = 2.21 [95% CI: 1.01-4.85]), and postpartum hemorrhage ≥ 1000 ml (adjusted OR = 2.20 [95% CI: 1.29-3.78]). We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85 [95% CI: 0.74-0.97]) and no associations between maternal BMI and neonatal outcomes.
CONCLUSIONS


Obese women in Ten-Group Classification System group 1 had increased risks of obstetric interventions and maternal complications. There was a gradient of risk for intrapartum cesarean section, with the highest risk for women in obesity classes II and III. No associations between maternal BMI and neonatal outcomes were observed.",2020,We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85,"['pre-obese women (adjusted OR = 0.85', 'nulliparous women originally included in a cluster randomized controlled trial carried out at 14 Norwegian obstetric units between 2014 and 2017', ""women were grouped according to the World Health Organization's BMI classifications: underweight (BMI < 18.5), normal weight (BMI 18.5-24.9), pre-obesity (BMI 25.0-29.9), obesity class"", '7189 nulliparous women with a singleton fetus, cephalic presentation and spontaneous onset of labor at term, denoted as group 1 in the Ten-Group Classification System', 'women of obesity class', 'nulliparous women with spontaneous onset of labor']",[],"['Maternal body mass index and risk of obstetric, maternal, and neonatal outcomes', 'obesity classes II and III', 'maternal BMI and neonatal outcomes', 'risk of intrapartum cesarean section', 'risk of amniotomy', 'oxytocin augmentation', 'obstetric anal sphincter injuries', 'spontaneous vaginal delivery', 'risks of obstetric interventions and maternal complications', 'risk of epidural analgesia', 'maternal body mass index (BMI']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C4517483', 'cui_str': '0.85'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1384591', 'cui_str': 'Artificial rupture of membranes'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]",7189.0,0.163517,We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85,"[{'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Obstetrics and Gynecology, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gunnes', 'Affiliation': ""Norwegian National Advisory Unit on Women's Health, Oslo University Hospital, Oslo, Norway.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Blix', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Torbjørn Moe', 'Initials': 'TM', 'LastName': 'Eggebø', 'Affiliation': 'National Centre for Fetal Medicine, St. Olavs hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Linn Tokheim', 'Initials': 'LT', 'LastName': 'Nistov', 'Affiliation': 'Department of Obstetrics and Gynecology, Vestfold Hospital Trust.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Norway, Tromsø, Norway.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Bernitz', 'Affiliation': 'Department of Obstetrics and Gynecology, Østfold Hospital Trust, Grålum, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14017']
3060,33031603,Efficacy of topical versus combined oral and topical antifungals in white piedra of the scalp.,"BACKGROUND


Topical antifungals are the most commonly used therapy in white piedra of the scalp. However, persistence and relapse of infection still pose a significant challenge. Systemic antifungals have been recommended to enhance the therapeutic response.
OBJECTIVES


To compare the efficacy of topical antifungal alone versus combined topical and oral antifungals in the treatment of white piedra of the scalp.
METHODS


Sixty patients with white piedra of the scalp were divided into 3 groups, each containing 20 patients. Group A received topical clotrimazole, group B received combined topical clotrimazole and oral itraconazole, and group C received combined topical clotrimazole and oral terbinafine. The treatment was continued until clearance of infection was confirmed by dermoscopic and mycological examination. Positive responders were followed-up for 3 months after treatment.
RESULTS


All the patients achieved complete clearance of infection. The median treatment time in group B was significantly shorter than group A (P<0.001) and group C (P<0.001) respectively. In addition, the median treatment time in group C was significantly shorter than group A (P=0.002). No recurrence of infection was noted during follow-up period.
CONCLUSION


The three modalities were effective in the treatment of white piedra of the scalp. The most rapid response was observed with the combined use of topical and oral azoles.",2020,The median treatment time in group B was significantly shorter than group A (P<0.001) and group C (P<0.001) respectively.,"['white piedra of the scalp', 'Sixty patients with white piedra of the scalp were divided into 3 groups, each containing 20 patients']","['combined topical clotrimazole and oral itraconazole, and group C received combined topical clotrimazole and oral terbinafine', 'topical clotrimazole', 'topical antifungal alone versus combined topical and oral antifungals', 'topical versus combined oral and topical antifungals']","['median treatment time', 'complete clearance of infection', 'recurrence of infection']","[{'cui': 'C0040249', 'cui_str': 'White piedra'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3208397', 'cui_str': 'Clotrimazole-containing product in cutaneous dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0342658,The median treatment time in group B was significantly shorter than group A (P<0.001) and group C (P<0.001) respectively.,"[{'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'El Attar', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Maii', 'Initials': 'M', 'LastName': 'Atef Shams Eldeen', 'Affiliation': 'Microbiology and Immunology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Wahid', 'Affiliation': 'Physiology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13769']
3061,33031636,Comparative evaluation of efficacy of enzymatic toothpaste over standard fluoridated toothpaste in reduction of plaque and gingivitis.,"OBJECTIVES


To compare and evaluate the efficacy of enzymatic toothpaste v/s standard fluoridated toothpaste in reduction of plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT).
MATERIALS AND METHODS


A total of 52 participants belonging to age 20-50 years eligible for inclusion were randomly chosen from the outpatient department. Computer generated randomisation was followed to recruit the subjects into two groups. 26 subjects were assigned to control group who were given with control toothpaste (Standard fluoridated toothpaste), while 26 subjects were assigned to test group (Enzymatic toothpaste) and given with test toothpaste. The amount of dental plaque and gingivitis were assessed baseline visit and at 6 week follow up visit using Turesky-Gilmore-Glickman modification of the Quigley-Hein plaque index (TQHPI) 1970, Gingival Index (GI) - (Löe and Sillness 1963) and Full Mouth Bleeding Score (FMBS) respectively. Data analysis was done using IBM SPSS® version 22.
RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow up visit. (p=0.006*, p=0.001*, p=0.001* respectively).
CONCLUSIONS


Within the limitations of our study, it can be concluded that test toothpaste has shown to be efficient than the previously set standard control fluoridated toothpaste in terms of reduction of plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT).",2020,"RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow up visit.","['26 subjects', 'plaque and gingivitis during maintenance phase after non-surgical periodontal therapy (NSPT', '52 participants belonging to age 20-50 years eligible for inclusion were randomly chosen from the outpatient department']","['test group (Enzymatic toothpaste) and given with test toothpaste', 'enzymatic toothpaste over standard fluoridated toothpaste', 'control toothpaste (Standard fluoridated toothpaste', 'enzymatic toothpaste v/s standard fluoridated toothpaste']","['Quigley-Hein plaque index (TQHPI) 1970, Gingival Index (GI) ', 'TQHPI, GI and FMBS', 'reduction of plaque and gingivitis', 'amount of dental plaque and gingivitis', 'Full Mouth Bleeding Score (FMBS']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0217445,"RESULTS


Intergroup comparison of TQHPI, GI and FMBS among test and control group has shown that test group had statistically significant lower values than the control group at the follow up visit.","[{'ForeName': 'Ashwin Parakkaje', 'Initials': 'AP', 'LastName': 'Subramanya', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, 562157, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Prabhuji', 'Affiliation': 'Intern, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, 562157, India.'}, {'ForeName': 'Karthikeyan Bangalore', 'Initials': 'KB', 'LastName': 'Vardhan', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, 562157, India.'}, {'ForeName': 'Prabhuji', 'Initials': 'P', 'LastName': 'Mlv', 'Affiliation': 'Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, 562157, India.'}]",International journal of dental hygiene,['10.1111/idh.12476']
3062,33017106,A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.,"BACKGROUND


Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis.
METHODS


We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith.
RESULTS


In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50).
CONCLUSIONS


For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).",2020,"Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43).","['1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure', 'patients with appendicitis at 25 U.S. centers', 'Appendicitis']","['Antibiotics with Appendectomy', 'antibiotic therapy (10-day course) with appendectomy']","['European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range', 'rate of serious adverse events', 'Complications', '30-day EQ-5D scores', '30-day health status', 'presence or absence of an appendicolith']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C3805175', 'cui_str': 'Appendicolith'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3805175', 'cui_str': 'Appendicolith'}]",1552.0,0.259779,"Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Flum', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Giana H', 'Initials': 'GH', 'LastName': 'Davidson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Monsell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Odom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sabrina E', 'Initials': 'SE', 'LastName': 'Sanchez', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'F Thurston', 'Initials': 'FT', 'LastName': 'Drake', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fischkoff', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Joe H', 'Initials': 'JH', 'LastName': 'Patton', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Evans', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cuschieri', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amber K', 'Initials': 'AK', 'LastName': 'Sabbatini', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Faine', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Dionne A', 'Initials': 'DA', 'LastName': 'Skeete', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Sohn', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McGrane', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Kutcher', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Damien W', 'Initials': 'DW', 'LastName': 'Carter', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ayoung-Chee', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chiang', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rushing', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Steinberg', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Careen S', 'Initials': 'CS', 'LastName': 'Foster', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Shaina M', 'Initials': 'SM', 'LastName': 'Schaetzel', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Thea P', 'Initials': 'TP', 'LastName': 'Price', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Mandell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ferrigno', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salzberg', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'DeUgarte', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Kaji', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Saltzman', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Callie M', 'Initials': 'CM', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Julianna T', 'Initials': 'JT', 'LastName': 'Yu', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Wiebusch', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Winchell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Sunday', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Krishnadasan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Fannon', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bizzell', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Talan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the University of Washington (D.R.F., G.H.D., S.M., A.K.S., E.F., D.C.L., B.A.C., P.J.H., L.G.K.), the Washington State Hospital Association (B.B.), Harborview Medical Center (H.E., J.C.), the Swedish Medical Center (K.A.M.), and the Virginia Mason Medical Center (J.T.Y., A.W.), Seattle, Madigan Army Medical Center, Tacoma (V.S., K.M.), and Providence Regional Medical Center Everett, Everett (C.S.F., S.M.S.) - all in Washington; Beth Israel Deaconess Medical Center (N.I.S., S.R.O.) and Boston University Medical Center (S.E.S., F.T.D.) - both in Boston; Columbia University Medical Center (K.F.), Tisch Hospital, NYU Langone Medical Center (P.A.-C., W.C.), Bellevue Hospital Center, NYU School of Medicine (P.A.-C., W.C.), and Weill Cornell Medical Center (R.J.W., S.C.) - all in New York; Henry Ford Health, Detroit (J.J., J.H.P.), and the University of Michigan, Ann Arbor (H.B.A., P.K.P.); University of Iowa Hospitals and Clinics, Iowa City (B.A.F., D.A.S.); the University of Texas Lyndon B. Johnson Medical Center (M.K.L.) and the University of Texas Health Science Center at Houston (L.S.K.) - both in Houston; the University of Mississippi Medical Center, Jackson (M.E.K.); Maine Medical Center, Portland (B.C., D.W.C.); Ohio State University Medical Center, Columbus (A.R., S.S.); Rush University Medical Center, Chicago (T.P.P.); UCHealth University of Colorado Hospital, Denver (L.F., M.S.); Harbor UCLA Medical Center (D.A.D., A.H.K.), Olive View UCLA Medical Center (G.J.M., D.S., A.K.), and Ronald Reagan UCLA Medical Center (D.A.T.) - all in Los Angeles; and Vanderbilt University Medical Center, Nashville (C.M.T., W.H.S.).'}]",The New England journal of medicine,['10.1056/NEJMoa2014320']
3063,33010799,The effect of Kinesio taping on cervical proprioception in athletes with mechanical neck pain-a placebo-controlled trial.,"BACKGROUND


Neck proprioception is critical in maintaining neuromuscular control in and around cervical joints. Kinesio™ tape may assist in rehabilitating joint position sense. The current study compares Kinesio™ tape's effects versus a placebo on proprioception in college athletes experiencing mechanical neck pain.
METHODS


This study randomized sixty-six athletes with mechanical neck pain into a Kinesio™ tape group (n = 33, mean age = 22.73 years) or placebo group (n = 33, mean age = 23.15 years). The Kinesio™ tape group received standard Kinesio™ taping applications with appropriate tension, while the placebo group received taping applications without tension.
OUTCOME MEASURES


The study assessed cervical joint position errors with a cervical range-of-motion (CROM) device, pain intensity with a visual analog scale (VAS), and neck functional disability with a neck disability index (NDI). It tested joint position errors through cervical flexion, extension, rotation left, and rotation right. All the outcome measures were recorded at the baseline and twice more following 3 and 7 days of tape applications.
RESULTS


Multivariate analysis of variance test demonstrated a significant reduction in joint position errors in flexion, extension and right rotation following 3 days and 7 days of tape application among the Kinesio™ tape group. There was a significant main effect of time (P < 0.05) for joint position errors in left rotation and VAS after 3 days (p > 0.05), NDI after 3 and 7 days (p > 0.05).
CONCLUSIONS


The Kinesio™ tape application after 3 and 7 days effectively decreased joint position errors and neck pain intensity in mechanical neck pain participants compared to placebo, while there was no difference between both groups in the NDI.
TRIAL REGISTRATION


( CTRI/2011/07/001925 ). This study was retrospectively registered on the 27th July, 2011.
LEVEL OF EVIDENCE


IIB.",2020,"The Kinesio™ tape application after 3 and 7 days effectively decreased joint position errors and neck pain intensity in mechanical neck pain participants compared to placebo, while there was no difference between both groups in the NDI.
","['sixty-six athletes with mechanical neck pain into a Kinesio™ tape group (n\u2009=\u200933, mean age\u2009=\u200922.73\u2009years) or', 'group (n\u2009=\u200933, mean age\u2009=\u200923.15\u2009years', 'mechanical neck pain participants', 'athletes with mechanical neck pain-a', 'college athletes experiencing mechanical neck pain']","['placebo', 'Kinesio taping', 'standard Kinesio™ taping applications with appropriate tension, while the placebo group received taping applications without tension', 'Kinesio™ tape']","['cervical proprioception', 'cervical joint position errors with a cervical range-of-motion (CROM) device, pain intensity with a visual analog scale (VAS), and neck functional disability with a neck disability index (NDI', 'joint position errors and neck pain intensity', 'joint position errors in flexion, extension and right rotation', 'joint position errors in left rotation and VAS']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",66.0,0.248822,"The Kinesio™ tape application after 3 and 7 days effectively decreased joint position errors and neck pain intensity in mechanical neck pain participants compared to placebo, while there was no difference between both groups in the NDI.
","[{'ForeName': 'Khalid A', 'Initials': 'KA', 'LastName': 'Alahmari', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ravi Shankar', 'Initials': 'RS', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia. rshankar@kku.edu.sa.'}, {'ForeName': 'Jaya Shanker', 'Initials': 'JS', 'LastName': 'Tedla', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Paul Silvian', 'Initials': 'PS', 'LastName': 'Samuel', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Venkata Nagaraj', 'Initials': 'VN', 'LastName': 'Kakaraparthi', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Kanagaraj', 'Initials': 'K', 'LastName': 'Rengaramanujam', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Irshad', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, King Khalid University, Abha, Saudi Arabia.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03681-9']
3064,33028408,Should the nail plate be replaced or discarded after nail bed repair in children? Nail bed INJury Analysis (NINJA) randomised controlled trial: a health economic and statistical analysis plan.,"BACKGROUND


Nail bed trauma is one of the most common surgically treated paediatric hand injuries in the UK. Despite surgeons generally expressing a preference to replace the nail plate after repairing the nail bed, there is limited evidence to support this practice. We describe a statistical and health economic analysis plan (SHEAP) for the Nail bed INJury Analysis (NINJA) randomised controlled trial.
METHODS/DESIGN


NINJA is a multicentre, pragmatic, superiority, parallel group randomised controlled trial of the treatment of nail bed injury in participants 16 years old or younger. The study aims to evaluate the efficacy and cost-effectiveness of replacing the nail plate compared to discarding it following the repair of a nail bed injury. Surgical site infection at 7-10 days post-randomisation and cosmetic appearance of the nail are the co-primary outcomes for NINJA. Surgical site infection at 7-10 days post-randomisation will be evaluated using a logistic regression model adjusting for site as the sole stratification factor and allowing for intra-site correlation. Cosmetic appearance will be assessed via the newly developed Oxford Finger Nail Appearance Score and will be evaluated by use of a Mann-Whitney U test. An ordinal logistic regression model will also be used to assess the Oxford Finger Nail Appearance Score, adjusting for site and allowing for intra-site correlation. Secondary outcomes are measured at 7-10 days and 4 months and include the EQ-5D-Y questionnaire, pain at first dressing change, cost-effectiveness, late surgical site infection, and participant/parent satisfaction with nail healing. Missing primary outcome data will be summarised by treatment arm and investigated through a sensitivity analysis. Full details of the planned methods of analysis and descriptive statistics are described in this paper. The NINJA study protocol has been published previously.
DISCUSSION


The planned analysis strategy for the NINJA trial has been set out here to reduce the risk of reporting bias and data-driven analysis. Any deviations from the SHEAP described in this paper will be detailed and justified fully in the final report of the trial.
TRIAL REGISTRATION


ISRCTN, ISRCTN44551796 . Registered on 23 April 2018.",2020,Surgical site infection at 7-10 days post-randomisation and cosmetic appearance of the nail are the co-primary outcomes for NINJA.,['participants 16\u2009years old or younger'],['nail plate'],"['Cosmetic appearance', 'efficacy and cost-effectiveness', 'EQ-5D-Y questionnaire, pain at first dressing change, cost-effectiveness, late surgical site infection, and participant/parent satisfaction with nail healing', 'Oxford Finger Nail Appearance Score', 'Surgical site infection']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.178731,Surgical site infection at 7-10 days post-randomisation and cosmetic appearance of the nail are the co-primary outcomes for NINJA.,"[{'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Stokes', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK. jamie.stokes@ndorms.ox.ac.uk.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Aina V H', 'Initials': 'AVH', 'LastName': 'Greig', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Beverly A', 'Initials': 'BA', 'LastName': 'Shirkey', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Oxford Clinical Trials Research Unit, Botnar Research Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK.'}]",Trials,['10.1186/s13063-020-04724-1']
3065,33028415,Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study).,"BACKGROUND


Although effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.
METHOD


Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average visual analog scale (VAS) score ≥ 5 will undergo a spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-month follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre- and post-randomization), and 6 months. The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1-, 3-, and 6-month follow-ups; responder rate (VAS score improving by 50%); achievement rate of a desirable pain state (VAS score ≤ 4); awake times during sleep; Beck Depression Inventory for depression evaluation; short-form 36 for quality of life evaluation; drug usage; and satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle.
DISCUSSION


The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03858790 . Registered on March 1, 2019, retrospectively registered.",2020,The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period.,"['patients with intractable trunk or limb pain', 'Participants will be recruited in approximately 10 centers across China', 'chronic pain patients', 'Eligible participants with intractable trunk or limb and an average visual analog scale (VAS) score\u2009≥\u20095 will undergo a spinal cord stimulation test', 'chronic intractable trunk or limb pain', 'Participants with VAS score reduction ≥\u200950% could move forward to receive implantation of an implanted pulse generator']","['Spinal cord stimulation', 'spinal cord stimulation', 'spinal cord stimulation plus remote programming management']","['Adverse events', 'VAS score change at 1-, 3-, and 6-month follow-ups; responder rate (VAS score improving by 50%); achievement rate of a desirable pain state (VAS score\u2009≤\u20094); awake times during sleep; Beck Depression Inventory for depression evaluation; short-form 36 for quality of life evaluation; drug usage; and satisfaction rating of the device', 'maximal VAS score between EG and CG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237638', 'cui_str': 'Generator'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.398106,The primary outcome is the difference of maximal VAS score between EG and CG in the withdrawal period compared with baseline before the withdrawal period.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Mao', 'Affiliation': 'Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guihuai', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': 'Department of Neurosurgery, Shenzhen University General Hospital, Shenzhen, China.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Xiong', 'Affiliation': 'Department of Pain Medicine, Huazhong University of Science and Technology of Union Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Algology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Rongchun', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Department of Pain Management, Wuhan Pu'ai Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Management, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Wanru', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Pain, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Pain Management, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Nanjing Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Pain Management, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Pain Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Daying', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Pain Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China. fbf1616@yeah.net.'}, {'ForeName': 'James Jin', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China. wja01068@btch.edu.cn.'}, {'ForeName': 'Luming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'National Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua University, Beijing, China. lilm@mail.tsinghua.edu.cn.'}]",Trials,['10.1186/s13063-020-04768-3']
3066,33028418,Impact of combined training with different exercise intensities on inflammatory and lipid markers in type 2 diabetes: a secondary analysis from a 1-year randomized controlled trial.,"BACKGROUND


Exercise is a well-accepted strategy to improve lipid and inflammatory profile in individuals with type 2 diabetes (T2DM). However, the exercise intensity having the most benefits on lipids and inflammatory markers in patients with T2DM remains unclear. We aimed to analyse the impact of a 1-year combined high-intensity interval training (HIIT) with resistance training (RT), and a moderate continuous training (MCT) with RT on inflammatory and lipid profile in individuals with T2DM.
METHODS


Individuals with T2DM (n = 80, aged 59 years) performed a 1-year randomized controlled trial and were randomized into three groups (control, n = 27; HIIT with RT, n = 25; MCT with RT, n = 28). Exercise sessions were supervised with a frequency of 3 days per week. Inflammatory and lipid profiles were measured at baseline and at 1-year follow-up. Changes in inflammatory and lipid markers were assessed using generalized estimating equations.
RESULTS


After adjusting for sex, age and baseline moderate-to-vigorous physical activity (MVPA), we observed a time-by-group interaction for Interleukin-6 (IL-6) in both the MCT with RT (β = - 0.70, p = 0.034) and HIIT with RT (β = - 0.62, p = 0.049) groups, whereas, only the HIIT with RT group improved total cholesterol (β = - 0.03, p = 0.045) and LDL-C (β = - 0.03, p = 0.034), when compared to control. No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p > 0.05).
CONCLUSIONS


Favorable adaptations on IL-6 were observed in both the HIIT and MCT combined with RT groups following a long-term 1-year exercise intervention in individuals with T2DM. However, only the HIIT with RT prevented further derangement of total cholesterol and LDL-C, when compared to the control group. Therefore, in order to encourage exercise participation and improve inflammatory profile, either exercise protocols may be prescribed, however, HIIT with RT may have further benefits on the lipid profile. Trial registration Clinicaltrials.gov ID: NCT03144505.",2020,"No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p > 0.05).
","['individuals with T2DM', 'individuals with type 2 diabetes (T2DM', 'type 2 diabetes', 'patients with T2DM', 'individuals with T2DM.\nMETHODS\n\n\nIndividuals with T2DM (n\u2009=\u200980, aged 59\xa0years']","['combined training with different exercise intensities', '1-year combined high-intensity interval training (HIIT) with resistance training (RT), and a moderate continuous training (MCT) with RT']","['inflammatory and lipid markers', 'total cholesterol', 'C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C', 'total cholesterol and LDL-C', 'IL-6', 'Inflammatory and lipid profiles']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0062480', 'cui_str': 'hemoglobin-haptoglobin receptor'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.0509168,"No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p > 0.05).
","[{'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Magalhães', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal. joao.magalhaes@campus.ul.pt.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Santos', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Inês R', 'Initials': 'IR', 'LastName': 'Correia', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hetherington-Rauth', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': 'Education and Research Centre, APDP-Diabetes Portugal (APDP-ERC), Rua Rodrigo da Fonseca 1, 1250-189, Lisbon, Portugal.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Raposo', 'Affiliation': 'Education and Research Centre, APDP-Diabetes Portugal (APDP-ERC), Rua Rodrigo da Fonseca 1, 1250-189, Lisbon, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Matos', 'Affiliation': 'Genetics Laboratory Environmental Health Institute (ISAMB), Faculty of Medicine, University of Lisbon, Avenida Professor Egas Moniz MB, 1649-028, Lisbon, Portugal.'}, {'ForeName': 'Manuel D', 'Initials': 'MD', 'LastName': 'Bicho', 'Affiliation': 'Genetics Laboratory Environmental Health Institute (ISAMB), Faculty of Medicine, University of Lisbon, Avenida Professor Egas Moniz MB, 1649-028, Lisbon, Portugal.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01136-y']
3067,33028425,Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.,"BACKGROUND


To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.
METHODS/DESIGN


The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.
DISCUSSION


This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.",2020,The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest.,['1900 participants will be enrolled'],"['Hypothermia Versus Targeted Normothermia', 'TTM']","['cause mortality', 'absolute risk reduction']",[],"[{'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",1900.0,0.144936,The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest.,"[{'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, Copenhagen, Denmark. jcj@ctu.dk.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Department of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Department of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Levin', 'Affiliation': 'Department of Clinical Sciences, Research and Education, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'Medical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hovdenes', 'Affiliation': 'Department of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, Faculty of Biology and Medicine, Centre Hospitalier Universitaire Vaudois (CHUV) - University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'Bankstown Hospital Clinical School and The George Institute for Global Health, University of New South Wales, Kensington, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Matt P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': ""University Collage Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Sciences, Anesthesia & Intensive Care, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Ullén', 'Affiliation': 'Clinical Studies Sweden, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund University, Helsingborg Hospital, Lund, Sweden.'}]",Trials,['10.1186/s13063-020-04654-y']
3068,33028427,The effect of flaxseed on physical and mental fatigue in children and adolescents with overweight/obesity.,"Anti-inflammatory agents such as long-chain ω-3 fatty acids have been recognized to improve disease-related fatigue. We hypothesized that α-linolenic acid may also benefit in reduction of fatigue in low-grade inflammation such as overweight/obesity. Seventy two healthy children and adolescents with body mass index (BMI) >25 kg/m2 were randomized to flaxseed (n=38) and puffed wheat (n=34) groups. Participants consumed isocaloric amounts of either 20 g/day flaxseed or 25 g/day puffed wheat for 4 weeks. Fatigue, mood feelings (depression, anxiety, and stress), appetite, energy intake, weight, height, and waist circumference were measured. Analysis was performed based on per-protocol (PP) and intention-to-treat (ITT) approaches. Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P<0.001). Although no significant change in physical and total score of fatigue was observed in either group, a significant between-group difference occurred due to a more remarkable change in these parameters in flaxseed group. General fatigue, motivation, activity, and mood feelings did not change significantly between groups. Flaxseed showed less benefit than puffed wheat on anthropometric measures as it caused smaller increase in height (0.53±0.89 vs. 1.09±0.87, P=0.03) and reduction in BMI (-0.25±0.63 vs. -0.67±0.56, P=0.01) than puffed wheat. Appetite and waist circumference decreased in both groups but no significant difference was observed between groups. In ITT analysis, only alteration in mental fatigue was significant. In conclusion, consumption of flaxseed may improve mental fatigue in children with overweight/obesity. However, because of smaller increase in height it is better to hinder administration of flaxseed in growth ages.",2020,Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P<0.001).,"['Seventy two healthy children and adolescents with body mass index (BMI) >25 kg/m2 were randomized to flaxseed (n=38) and puffed wheat (n=34) groups', 'children with overweight/obesity', 'children and adolescents with overweight/obesity']","['flaxseed', 'α-linolenic acid']","['BMI', 'mental fatigue', 'height', 'Appetite and waist circumference', 'Fatigue, mood feelings (depression, anxiety, and stress), appetite, energy intake, weight, height, and waist circumference', 'physical and total score of fatigue', 'physical and mental fatigue', 'General fatigue, motivation, activity, and mood feelings']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",72.0,0.0455585,Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P<0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Gholami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Akhlaghi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520003888']
3069,33028623,Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850).,"OBJECTIVE


To investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.
METHODS


Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.
RESULTS


171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
CONCLUSIONS


Neoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.",2020,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","['Patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy', '171 patients', 'advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load', 'Patients with high tumor load assessed by a standardized laparoscopic predictive index']","['primary debulking surgery', 'primary debulking surgery versus neoadjuvant chemotherapy', 'primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B', 'neoadjuvant chemotherapy followed by interval debulking surgery', 'neoadjuvant chemotherapy']","['progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life', 'Median progression-free and overall survival', 'disease progressions/recurrences and 103 deaths', 'toxicity profile', 'advanced epithelial ovarian cancer', '53 major postoperative complications', 'Rates of complete resection (R0']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}]",171.0,0.400373,"Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy annafagotti70@gmail.com.'}, {'ForeName': 'Maria Gabriella', 'Initials': 'MG', 'LastName': 'Ferrandina', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Vizzielli', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pasciuto', 'Affiliation': 'Statistics Technology Archiving Research (STAR) Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gallotta', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Pasquale Alessandro', 'Initials': 'PA', 'LastName': 'Margariti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Chiantera', 'Affiliation': 'Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Costantini', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'S Gueli', 'Initials': 'SG', 'LastName': 'Alletti', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': 'Gynecologic Oncology, Gemelli Molise spa, Università Cattolica del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Woman, Child and Public Health Department, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001640']
3070,33028649,Healthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial.,"INTRODUCTION


Older Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people.
METHODS


We will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated.
CONCLUSION


This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services.
TRIAL REGISTRATION NUMBER


ACTRN12619000349145.",2020,This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years.,"['Aboriginal people aged 45 years and older in three Australian states', 'Healthy ageing among older Aboriginal people', 'Aboriginal peoples aged ≥45 years', 'Aboriginal participants', 'older Aboriginal people', 'partnership with Aboriginal communities, the Ironbark']","['Ironbark group-based fall prevention programme', 'fall prevention programme', 'Standing Strong and Tall programme']","['community acceptability and feasibility, and gains in balance and strength', 'effectiveness and cost-effectiveness', 'fall rates over 12 months, measured using weekly self-reported data', 'quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}]",,0.119015,This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ivers', 'Affiliation': 'School of Population Health, University of New South Wales, Sydney, New South Wales, Australia rebecca.ivers@unsw.edu.au.'}, {'ForeName': 'Julieann', 'Initials': 'J', 'LastName': 'Coombes', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Mackean', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Ryder', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Macniven', 'Affiliation': 'School of Population Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clapham', 'Affiliation': 'Ngarruwan Ngadju First Peoples Health and Wellbeing Research Centre, Australian Health Services Research Institute, The University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2020-043915']
3071,33028663,Safety and efficacy of remote ischemic postconditioning after thrombolysis in patients with stroke.,"OBJECTIVE


To determine the effect of remote ischemic post-conditioning (RIPC) on acute ischemic stroke (AIS) patients undergoing intravenous thrombolysis (IVT).
METHODS


A single-center, randomized controlled trial was performed with AIS patients receiving IVT. Patients in the RIPC group were administered RIPC treatment (after IVT) during hospitalization. The primary endpoint was a score of 0 or 1 on the modified Rankin scale (mRS) at day 90. The safety, tolerability and neuroprotection biomarkers associated with RIPC were also examined.
RESULTS


We collected data from both RIPC (n=34) and controls (n=34). The average duration of hospitalization was 11.2 days. There was no significant difference between the two groups at admission for the NIHSS score (p=0.364) or occur to treatment time (p=0.889). An excellent recovery (mRS 0-1) at 3 months was obtained in 71.9% of the patients in the RIPC group vs 50.0% in the control group (adjusted risk ratio, 9.85; 95% CI, 1.54 to 63.16; P = 0.016). We further found significantly lower plasma S100 β (p=0.007) and higher vascular endothelial growth factor (p = 0.003) levels in the RIPC group than in controls.
CONCLUSIONS


Repeated RIPC combined with IVT can significantly facilitate recovery of nerve function and improve clinical prognosis of patients with AIS.
CLINICALTRIALGOV IDENTIFIER


NCT03218293 CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that RIPC following tPA treatment of AIS significantly increases the proportion of patients with MRS 0 or 1 at 90 days.",2020,There was no significant difference between the two groups at admission for the NIHSS score (p=0.364) or occur to treatment time (p=0.889).,"['patients with AIS', 'n=34) and controls (n=34', 'patients with stroke', 'acute ischemic stroke (AIS) patients undergoing intravenous thrombolysis (IVT']","['RIPC', 'remote ischemic postconditioning', 'remote ischemic post-conditioning (RIPC', 'IVT', 'RIPC combined with IVT']","['safety, tolerability and neuroprotection biomarkers', 'Safety and efficacy', 'vascular endothelial growth factor', 'plasma S100 β', 'NIHSS score', 'score of 0 or 1 on the modified Rankin scale (mRS', 'average duration of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.208657,There was no significant difference between the two groups at admission for the NIHSS score (p=0.364) or occur to treatment time (p=0.889).,"[{'ForeName': 'Jia-Qi', 'Initials': 'JQ', 'LastName': 'An', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China lguogang@163.com liguoliang_med@163.com.""}, {'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Cheng', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Guo', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China lguogang@163.com liguoliang_med@163.com.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Gong', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Yong-Lan', 'Initials': 'YL', 'LastName': 'Tang', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Xing-Yun', 'Initials': 'XY', 'LastName': 'Yuan', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Song', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Chun-Ying', 'Initials': 'CY', 'LastName': 'Mu', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China.""}, {'ForeName': 'Ai-Feng', 'Initials': 'AF', 'LastName': 'Zhang', 'Affiliation': ""Renal Division, Brigham and Women's Hospital, Harvard Medical School. 77 Avenue Louis Pasteur, Boston, MA, 02115, USA.""}, {'ForeName': 'Ardan M', 'Initials': 'AM', 'LastName': 'Saguner', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, Rämistrasse 100, 8091 Zürich, Switzerland.'}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Li', 'Affiliation': ""Atrial Fibrillation Centre and Department of Cardiovascular Medicine, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China lguogang@163.com liguoliang_med@163.com.""}, {'ForeName': 'Guo-Gang', 'Initials': 'GG', 'LastName': 'Luo', 'Affiliation': ""Stroke Centre and Department of Neurology, the First Affiliated Hospital of Xi'an Jiaotong University, No. 76 Yanta West Road, Xi'an 710061, China lguogang@163.com liguoliang_med@163.com.""}]",Neurology,['10.1212/WNL.0000000000010884']
3072,33028675,Changes in selected haematological parameters associated with JAK1/JAK2 inhibition observed in patients with rheumatoid arthritis treated with baricitinib.,"OBJECTIVE


To characterise changes in selected haematological parameters following once-daily oral baricitinib dosing.
METHODS


Data were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension. Changes in haematological parameters were evaluated up to 128 weeks (N=2387); overall safety of baricitinib was assessed up to 6 years (N=3492).
RESULTS


Mean absolute neutrophil counts decreased (-1.36×10 9 /L) within 1 month, followed by stabilisation within the normal reference range through week 128. The incidence of serious infections was not elevated in patients with neutropenia during the 24-week placebo-controlled period. Mean lymphocyte counts increased (+0.30×10 9 /L) within 1 month, then decreased to baseline (weeks 12-24). Mean platelet counts increased at week 2 (+51×10 9 /L), then decreased towards baseline. Overall, mean haemoglobin concentrations decreased (-0.12 mmol/L), then returned to baseline; however, reduced baseline haemoglobin concentrations observed in the highest baseline high-sensitivity C reactive protein quartile increased over time. Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).
CONCLUSIONS


Moderate decreases in neutrophils were seen during baricitinib treatment; however, serious infection was uncommon in patients with neutropenia. Transient increases were observed in lymphocytes and platelets, which returned to baseline over time. Changes in haemoglobin concentration were generally small. Haematological abnormalities seldom led to drug discontinuation.",2020,"Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).
","['patients with rheumatoid arthritis treated with baricitinib', 'Data were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension', 'patients with neutropenia during the 24-week']",['placebo'],"['Mean lymphocyte counts', 'mean haemoglobin concentrations', 'neutrophils', 'serious infection', 'neutrophil count', 'platelet counts', 'overall safety of baricitinib', 'incidence of serious infections', 'baseline haemoglobin concentrations', 'haemoglobin levels', 'haematological parameters', 'haemoglobin concentration', 'Mean platelet counts', 'lymphocyte counts', 'Mean absolute neutrophil counts', 'lymphocytes and platelets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",,0.061901,"Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center, Worcester, Massachusetts, USA jonathan.kay@umassmemorial.org.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Harigai', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Rancourt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dickson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melby', 'Affiliation': 'Syneos Health, Morrisville, North Carolina, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Cardoso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Chadi', 'Initials': 'C', 'LastName': 'Saifan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Amsterdam Universitair Medische Centra, Amsterdam, The Netherlands.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Giles', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York City, New York, USA.'}, {'ForeName': 'Tom Wj', 'Initials': 'TW', 'LastName': 'Huizinga', 'Affiliation': 'Department of Rheumatology, Leids Universitair Medisch Centrum, Leiden, The Netherlands.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Kremer', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Albany Medical College, Albany, New York, USA.'}]",RMD open,['10.1136/rmdopen-2020-001370']
3073,33031764,"Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.","BACKGROUND


Lopinavir-ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir-ritonavir improves outcomes in patients admitted to hospital with COVID-19.
METHODS


In this randomised, controlled, open-label, platform trial, a range of possible treatments was compared with usual care in patients admitted to hospital with COVID-19. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir-ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge (or one of the other RECOVERY treatment groups: hydroxychloroquine, dexamethasone, or azithromycin) using web-based simple (unstratified) randomisation with allocation concealment. Randomisation to usual care was twice that of any of the active treatment groups (eg, 2:1 in favour of usual care if the patient was eligible for only one active group, 2:1:1 if the patient was eligible for two active groups). The primary outcome was 28-day all-cause mortality. Analyses were done on an intention-to-treat basis in all randomly assigned participants. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
FINDINGS


Between March 19, 2020, and June 29, 2020, 1616 patients were randomly allocated to receive lopinavir-ritonavir and 3424 patients to receive usual care. Overall, 374 (23%) patients allocated to lopinavir-ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio 1·03, 95% CI 0·91-1·17; p=0·60). Results were consistent across all prespecified subgroups of patients. We observed no significant difference in time until discharge alive from hospital (median 11 days [IQR 5 to >28] in both groups) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 0·98, 95% CI 0·91-1·05; p=0·53). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
INTERPRETATION


In patients admitted to hospital with COVID-19, lopinavir-ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir-ritonavir for treatment of patients admitted to hospital with COVID-19.
FUNDING


Medical Research Council and National Institute for Health Research.",2020,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","['and 3424 patients to receive', 'Between March 19, 2020, and June 29, 2020, 1616 patients', 'patients admitted to hospital with COVID-19 (RECOVERY', '176 hospitals in the UK', 'Eligible and consenting patients', 'patients admitted to hospital with COVID-19']","['Lopinavir-ritonavir', 'usual standard of care alone or usual standard of care plus lopinavir-ritonavir', 'lopinavir-ritonavir', 'usual care', 'hydroxychloroquine, dexamethasone, or azithromycin']","['time until discharge alive from hospital', '28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death', '28-day all-cause mortality', 'composite endpoint of invasive mechanical ventilation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",1616.0,0.208399,"Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99-1·20; p=0·092).
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32013-4']
3074,33031809,Cross-Linking Assisted Infection Reduction (CLAIR): One-year Follow-up from a Randomized Clinical Trial Evaluating Adjuvant Cross-Linking in the Treatment of Fungal Keratitis.,,2020,,['Fungal Keratitis'],['Cross-Linking Assisted Infection Reduction (CLAIR'],[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.0700031,,"[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lalitha', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA; UCSF Department of Ophthalmology, University of California, San Francisco, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA; UCSF Epidemiology and Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA; UCSF Epidemiology and Biostatistics, University of California, San Francisco, USA; UCSF Department of Ophthalmology, University of California, San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, USA; UCSF Department of Ophthalmology, University of California, San Francisco, USA; Adjunct Investigator, Division of Research, Kaiser Permanente Northern California. Electronic address: jennifer.rose.nussbaumer@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.09.042']
3075,33031829,Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of the IMPACT Trial.,"BACKGROUND


In the IMPACT trial, single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI and UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations, with a similar safety profile. Research Question Does age have an effect on trial outcomes?
STUDY DESIGN AND METHODS


IMPACT was a Phase III, double-blind, 52-week trial. Patients ≥40 years of age with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 mcg, FF/VI 100/25 mcg, or UMEC/VI 62.5/25 mcg. Endpoints assessed by age included annual rate of moderate/severe exacerbations, change from baseline (CFB) in trough forced expiratory volume in 1 second (FEV 1 ), proportion of St George's Respiratory Questionnaire (SGRQ) responders (≥4 units decrease from baseline in SGRQ total score) and safety.
RESULTS


The intent-to-treat population comprised 10,355 patients; 4724 (46%), 4225 (41%), and 1406 (14%) were ≤64, 65-74, and ≥75 years of age, respectively. FF/UMEC/VI reduced on-treatment moderate/severe exacerbation rates versus FF/VI (% reduction [95% confidence interval (CI)], ≤64 years: 8% [-1, 16], p=0.070; 65-74 years: 22% [14, 29], p<0.001; ≥75 years 18% [3, 31], p=0.021) and versus UMEC/VI (≤64 years: 16% [7, 25], p=0.002; 65-74 years: 33% [25, 41], p<0.001; ≥75 years 24% [6, 38], p=0.012), with greatest rate reduction seen in the 65-74 and ≥75 years subgroups. Post hoc analyses of CFB in trough FEV 1 , and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups. No new safety signals were identified.
INTERPRETATION


FF/UMEC/VI reduced the rate of moderate/severe exacerbations and improved lung function and health status versus FF/VI and UMEC/VI irrespective of age for most endpoints, with a similar safety profile.
CLINICAL TRIAL REGISTRATION


GSK (CTT116855/NCT02164513).",2020,"Post hoc analyses of CFB in trough FEV 1 , and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups.","['patients with symptomatic chronic obstructive pulmonary disease (COPD', 'Patients ≥40 years of age with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year', 'Patients With Chronic Obstructive Pulmonary Disease', '10,355 patients; 4724 (46%), 4225 (41%), and 1406 (14%) were ≤64, 65-74, and ≥75 years of age, respectively']","['Once-Daily Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol', 'FF/UMEC/VI 100/62.5/25 mcg, FF/VI 100/25 mcg, or UMEC/VI 62.5/25 mcg', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI']","['FF/UMEC/VI reduced on-treatment moderate/severe exacerbation rates', ""annual rate of moderate/severe exacerbations, change from baseline (CFB) in trough forced expiratory volume in 1 second (FEV 1 ), proportion of St George's Respiratory Questionnaire (SGRQ) responders (≥4 units decrease from baseline in SGRQ total score) and safety"", 'rate of moderate/severe exacerbations and improved lung function and health status', 'Efficacy and Safety', 'CFB in trough FEV 1 , and proportion of SGRQ responders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.708903,"Post hoc analyses of CFB in trough FEV 1 , and proportion of SGRQ responders at Week 52 were significantly greater with FF/UMEC/VI than FF/VI or UMEC/VI in all subgroups.","[{'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Airways Clinical Research Center, Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA. Electronic address: hanania@bcm.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Mannino', 'Affiliation': 'Department of Preventative Medicine and Environmental Health, University of Kentucky, College of Public Health, Lexington, KY, USA; GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GSK, Brentford, Middlesex, UK; University of Leicester, Leicester, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Robson', 'Initials': 'R', 'LastName': 'Lima', 'Affiliation': 'GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, Collegeville, PA, USA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Chest,['10.1016/j.chest.2020.09.253']
3076,33031833,"Fibrates for itch (FITCH) in fibrosing cholangiopathies: a double blind, randomized, placebo-controlled trial.","BACKGROUND AND AIMS


Pruritus may seriously impair quality of life in patients with cholestatic diseases such as primary or secondary sclerosing cholangitis (PSC, SSC) and primary biliary cholangitis (PBC). Pharmacological strategies show limited efficacy and can provoke serious side effects. We hypothesized that bezafibrate, a broad peroxisome proliferator-activated receptor (PPAR) agonist, relieves cholestasis-associated itch by alleviating hepatobiliary injury. The aim of this investigator-initiated FITCH trial (""Fibrates for cholestatic ITCH"") was to assess effects of bezafibrate on pruritus in patients with PSC, PBC and SSC.
METHODS


Patients with moderate to severe pruritus (>5 out of 10 on visual analogue scale (VAS)) due to PSC, PBC or SSC were recruited for this double-blind, randomized, placebo-controlled trial between 2016 and 2019. Patients received once-daily bezafibrate (400mg) or placebo for 21 days. The primary endpoint was >50% reduction of pruritus (VAS; intention-to-treat).
RESULTS


70 of 74 randomized patients completed the trial (95%; 44 PSC, 24 PBC, 2 SSC). For the primary endpoint, bezafibrate led in 45% (41% PSC, 55% PBC), placebo in 11% to >50% reduction of severe or moderate pruritus (p=0.003). For secondary endpoints, bezafibrate reduced morning (p=0.01 vs. placebo) and evening (p=0.007) intensity of pruritus (VAS) and improved the validated 5D-itch-questionnaire (p=0.002 vs. placebo). Bezafibrate also reduced serum alkaline phosphatase (-35%, p=0.03 vs. placebo) correlating with improved pruritus (VAS, p=0.01) suggesting reduced biliary damage. Serum bile acids and autotaxin activity remained unchanged. Serum creatinine levels tended to mildly increase (3% bezafibrate, 5% placebo, p=0.14).
CONCLUSION


Bezafibrate is superior to placebo in improving moderate to severe pruritus in patients with PSC and PBC.
TRIAL REGISTRATION


Netherlands Trial Register, ID: NTR5436 (3 August 2015), ClinicalTrials.gov ID: NCT02701166 (2 March 2016).",2020,"Bezafibrate also reduced serum alkaline phosphatase (-35%, p=0.03 vs. placebo) correlating with improved pruritus (VAS, p=0.01) suggesting reduced biliary damage.","['patients with PSC, PBC and SSC.\nMETHODS\n\n\nPatients with moderate to severe pruritus (>5 out of 10 on visual analogue scale (VAS)) due to PSC, PBC or SSC', '70 of 74 randomized patients completed the trial (95%; 44 PSC, 24 PBC, 2 SSC', 'fibrosing cholangiopathies', 'patients with PSC and PBC', 'patients with cholestatic diseases such as primary or secondary sclerosing cholangitis (PSC, SSC) and primary biliary cholangitis (PBC']","['NTR5436', 'Bezafibrate', 'Fibrates', 'bezafibrate', 'placebo']","['biliary damage', 'validated 5D-itch-questionnaire', 'intensity of pruritus (VAS', 'severe or moderate pruritus', 'Serum bile acids and autotaxin activity', 'Serum creatinine levels', 'serum alkaline phosphatase', 'pruritus (VAS; intention-to-treat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0400978', 'cui_str': 'Secondary sclerosing cholangitis'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C1449704', 'cui_str': 'Fibrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1384621', 'cui_str': 'ENPP2 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",,0.800504,"Bezafibrate also reduced serum alkaline phosphatase (-35%, p=0.03 vs. placebo) correlating with improved pruritus (VAS, p=0.01) suggesting reduced biliary damage.","[{'ForeName': 'Elsemieke', 'Initials': 'E', 'LastName': 'de Vries', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bolier', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Goet', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Parés', 'Affiliation': 'Liver Unit, Hospital Clinic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jef', 'Initials': 'J', 'LastName': 'Verbeek', 'Affiliation': 'Department of Gastroenterology & Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'de Vree', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology & Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'van Erpecum', 'Affiliation': 'Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'van Nieuwkerk', 'Affiliation': 'Department of Gastroenterology & Hepatology, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'van der Heide', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mostafavi', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeltje', 'Initials': 'J', 'LastName': 'Helder', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Cyriel', 'Initials': 'C', 'LastName': 'Ponsioen', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald Oude', 'Initials': 'RO', 'LastName': 'Elferink', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van Buuren', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beuers', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Centers, location AMC, Amsterdam, The Netherlands. Electronic address: u.h.beuers@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.10.001']
3077,33031838,Long-pulsed Nd:YAG laser versus cryotherapy for the treatment of cutaneous warts: a randomized controlled trial.,"BACKGROUND


Observational studies have shown promising therapeutic effects of long-pulsed neodymium-doped yttrium aluminum garnet (LP-Nd:YAG) laser on warts.
OBJECTIVE


To evaluate whether LP-Nd:YAG laser was superior to cryotherapy for cutaneous warts.
METHODS


In this study, 150 adult patients with warts were randomized equally to receive laser or cryotherapy every 3-4 weeks, a maximum of 4 sessions. The primary outcomes were cure rate at 16 weeks and 6 months; secondary outcomes included time to clearance of warts and treatment-related adverse effects.
RESULTS


There was no difference in the cure rate for laser versus cryotherapy at 16 weeks (54.1% vs. 46.7%) and 6 months (59.5% vs. 57.3%). However, time to clearance of warts, up to 16 weeks and 6 months, tended to be shorter for laser versus cryotherapy ( P = .04 and .08, respectively). Post-hoc analyses showed a significantly higher cure rate for laser versus cryotherapy in 3 subgroups of HPV 2/27/57-induced recalcitrant warts, but not in their counterpart subgroups. Laser had more mild adverse effects.
LIMITATIONS


Single-center.
CONCLUSIONS


The overall therapeutic effects of LP-Nd:YAG laser were similar to cryotherapy, but laser may be more effective to relatively recalcitrant warts and may associate with shorter time to clearance of warts.",2020,"Post-hoc analyses showed a significantly higher cure rate for laser versus cryotherapy in 3 subgroups of HPV 2/27/57-induced recalcitrant warts, but not in their counterpart subgroups.","['150 adult patients with warts', 'cutaneous warts']","['Long-pulsed Nd:YAG laser versus cryotherapy', 'pulsed neodymium-doped yttrium aluminum garnet (LP-Nd:YAG) laser', 'LP-Nd:YAG laser', 'laser versus cryotherapy', 'laser or cryotherapy']","['time to clearance of warts and treatment-related adverse effects', 'mild adverse effects', 'cure rate', 'time to clearance of warts']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",150.0,0.101035,"Post-hoc analyses showed a significantly higher cure rate for laser versus cryotherapy in 3 subgroups of HPV 2/27/57-induced recalcitrant warts, but not in their counterpart subgroups.","[{'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatology, 306 Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Hong-Tian', 'Initials': 'HT', 'LastName': 'Li', 'Affiliation': 'Institute of Reproductive and Child Health/National Health Commission Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Ying-Yun', 'Initials': 'YY', 'LastName': 'Ren', 'Affiliation': 'Department of Dermatology, Foresea Life Insurance Guangzhou General Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, The Second People Hospital of Wuqing, Tianjin, China.'}, {'ForeName': 'Zhi-Hao', 'Initials': 'ZH', 'LastName': 'Cheng', 'Affiliation': 'Institute of Reproductive and Child Health/National Health Commission Key Laboratory of Reproductive Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Tian-Bao', 'Initials': 'TB', 'LastName': 'Xia', 'Affiliation': ""Department of Dermatology, 306 Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Jun-Lian', 'Initials': 'JL', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatology, 306 Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Xiao-Jia', 'Initials': 'XJ', 'LastName': 'Cao', 'Affiliation': ""Department of Dermatology, 306 Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Shi-Chao', 'Initials': 'SC', 'LastName': 'Lu', 'Affiliation': ""Department of Dermatology, 306 Hospital of People's Liberation Army, Beijing, China. Electronic address: lvshichao@sina.com.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.085']
3078,33031846,Proton beam radiotherapy vs. radiofrequency ablation for recurrent hepatocellular carcinoma: a randomized phase trial.,"BACKGROUND & AIMS


Proton beam radiotherapy (PBT) has recently been applied to treat hepatocellular carcinoma (HCC); however, there is no randomized controlled trial-based evidence on its safety and efficacy. We compared the outcomes of PBT and radiofrequency ablation (RFA) in patients with recurrent/residual HCC (rHCC) in a phase III non-inferiority trial.
METHODS


Patients with rHCC (size <3 cm, number ≤2) were randomly assigned to receive PBT or RFA according to the Child-Pugh score and tumor stage. After randomization, if the assigned treatment was technically infeasible, crossover was allowed. The primary endpoint was 2-year local progression-free survival (LPFS), with a non-inferiority margin of 15% in per-protocol (PP) population and complementarily in intention-to-treat (ITT) population (NCT01963429).
RESULTS


The ITT population comprised 144 PBT (n=72) and RFA (n=72) patients. Six patients in PBT arm switched to RFA, while 19 in RFA arm switched to PBT. In the PP population, the 2-year LPFS rate with PBT (n=80) vs. RFA (n=56) was 94.8% vs. 83.9%, a difference of 10.9 percentage points (90% confidence interval [CI], 1.8-20.0; p < 0.001); in the ITT population, the 2-year LPFS rate with PBT vs. RFA was 92.8% vs. 83.2%, a difference of 9.6 percentage points (90% CI, 0.7-18.4; p <0.001), meeting the criteria for non-inferiority. The 3- and 4-year LPFS rates for PBT were also non-inferior to those for RFA. The most common adverse events (AEs) were radiation pneumonitis (32.5%) and decreased leukocyte counts (23.8%) for PBT and increased alanine aminotransferase levels (96.4%) and abdominal pain (30.4%) for RFA. No Grade 4 AEs or mortality were noted.
CONCLUSIONS


PBT showed LPFS values that were non-inferior to those for RFA and were tolerable and safe.",2020,The 3- and 4-year LPFS rates for PBT were also non-inferior to those for RFA.,"['The ITT population comprised 144 PBT (n=72) and RFA (n=72) patients', 'recurrent hepatocellular carcinoma', 'hepatocellular carcinoma (HCC', 'Patients with rHCC (size <3 cm, number ≤2', 'patients with recurrent/residual HCC (rHCC) in a phase III non-inferiority trial']","['PBT and radiofrequency ablation (RFA', 'PBT or RFA', 'RFA', 'Proton beam radiotherapy vs. radiofrequency ablation', 'PBT', 'Proton beam radiotherapy (PBT']","['tolerable and safe', '2-year local progression-free survival (LPFS), with a non-inferiority margin of 15% in per-protocol (PP) population and complementarily in intention-to-treat (ITT', '2-year LPFS rate', 'Grade 4 AEs or mortality', 'abdominal pain', '3- and 4-year LPFS rates for PBT', '2-year LPFS rate with PBT vs. RFA', 'leukocyte counts', 'alanine aminotransferase levels', 'LPFS values', 'radiation pneumonitis']","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0729603', 'cui_str': 'Proton beam'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861876', 'cui_str': 'Hepatocellular carcinoma recurrent'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}]","[{'cui': 'C0729603', 'cui_str': 'Proton beam'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0729603', 'cui_str': 'Proton beam'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0206063', 'cui_str': 'Radiation pneumonitis'}]",,0.298017,The 3- and 4-year LPFS rates for PBT were also non-inferior to those for RFA.,"[{'ForeName': 'Tae Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea; Center for Proton Therapy, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'Koh', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea; Department of Radiology, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Bo Hyun', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Min Ju', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Ju Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea; Department of Radiology, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, Republic of Korea. Electronic address: jwpark@ncc.re.kr.'}]",Journal of hepatology,['10.1016/j.jhep.2020.09.026']
3079,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
3080,33031956,CITY health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the beat HIVe project.,"BACKGROUND


Despite multiple efforts to reduce HIV rates among African American young adults, a significant racial disparity persists and continues to grow among this population. New approaches are needed to reach this at-risk group and engage them in prevention efforts. The Community Influences Transitions of Youth Health (CITY Health II) study aims to increase HIV preventive behaviors to decrease HIV rates among 18-25 year old African American emerging adults living in resource-poor southern urban communities.
METHODS


CITY Health II is a 5-year HIV prevention study that evaluates the efficacy of a peer-driven entertainment education intervention compared to an attention-control intervention using a cluster randomized trial design. Participants were recruited through respondent-driven sampling (RDS) to participate in a social media intervention. We enlisted eight musicians and groups to help us create an entertaining and educational web-based video series, ""The Beat HIVe"", for study participants to view on smartphones and share with peers on social media. Data collection interviews at baseline, 3-month, and 6-month follow-up assessed socio-demographics, risk and protective behaviors, social networks, and peer norms. Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
DISCUSSION


Outcomes will inform ways to engage African American emerging adults through entertainment education and other strategies for increasing optimal sexual health behaviors.
TRIAL REGISTRATION


NCT04320186.",2020,"Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
","['Participants were recruited through respondent-driven sampling (RDS) to participate in a social media intervention', '18-25\u202fyear old African American emerging adults living in resource-poor southern urban communities', 'African American young adults', 'CITY Health II']","['attention-control intervention', 'peer-driven entertainment education intervention']","['HIV rates', 'socio-demographics, risk and protective behaviors, social networks, and peer norms']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",,0.0463693,"Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Davies', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA. Electronic address: sdavies@uab.edu.'}, {'ForeName': 'Tamika L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Crawford', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Kaiser', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Olivio J', 'Initials': 'OJ', 'LastName': 'Clay', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106167']
3081,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
3082,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE


Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN


A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING


52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP


304 US-trained practicing anesthesiologists.
INTERVENTIONS


The absence or presence of the EM during the simulation case.
MEASUREMENTS


Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS


Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS


Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
3083,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE


The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN


Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS


For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION


The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
3084,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND


Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES


This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS


We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION


This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
3085,33032168,COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.,"BACKGROUND


Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients.
METHODS


In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations.
FINDINGS


At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
INTERPRETATION


COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.",2020,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
",['moderate and severe chronic obstructive pulmonary disease exacerbations'],['COPDCompEx'],"['peak expiratory flow, reliever medication use, and symptoms', 'proportion of patients experiencing COPDCompEx events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.362478,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
","[{'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany, Member of the German Center for Lung Research (DZL).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fuhlbrigge', 'Affiliation': 'Pulmonary Sciences and Critical Care, Department of Medicine, University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jauhiainen', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Lieke E J M', 'Initials': 'LEJM', 'LastName': 'Scheepers', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Emeritus Professor Respiratory Medicine, Kings College, London, UK; Galecto Biotech, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Locantore', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rennard', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Cambridge, UK.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'AstraZeneca, Early Respiratory & Immunology (R&I) Clinical Development, BioPharmaceuticals R&D, Gothenburg, Sweden. Electronic address: Carla.DaSilva@astrazeneca.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106175']
3086,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES


We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS


Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS


We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2  = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2  = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS


Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
3087,33032234,Periodontal treatment and vascular inflammation in patients with advanced peripheral arterial disease: A randomized controlled trial.,"BACKGROUND AND AIMS


Observational studies support an association between periodontitis and cardiovascular diseases. The study objective was to assess vascular inflammation after periodontal treatment in patients with peripheral arterial disease.
METHODS


Ninety patients with peripheral arterial disease (PAD) and severe periodontitis were enrolled in a randomized, controlled trial. Thirty patients underwent non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group). The remaining thirty patients did not receive periodontal therapy (CG, control group). The primary outcome of this treatment was a reduction in vascular inflammation three months after periodontal treatment as determined by  18 F-FDG PET/CT values. Secondary outcomes were changes in the inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events.
RESULTS


After three months of treatment, a significant improvement in periodontal health was observed in the treatment groups. However, no difference in the primary outcome in the aorta was observed in the three study groups (median target to background ratio follow-up/baseline, PT1 1.00; 95% CI 0.97-1.10, PT2 1.00; 95% CI 0.98-1.1, CG 1.1; 95% CI 0.99-1.1, p = 0.75). No significant differences were detected in most diseased segments and active segments. In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries. No differences with regard to relative changes in vascular biomarkers were noted, and no serious cardiovascular adverse events occurred.
CONCLUSIONS


Periodontal treatment was effective and safe but did not reduce vascular inflammation in patients with PAD.",2020,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","['Ninety patients with peripheral arterial disease (PAD) and severe periodontitis', 'patients with peripheral arterial disease', 'patients with PAD', 'patients with advanced peripheral arterial disease', 'Thirty patients underwent']","['non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group']","['vascular inflammation', 'periodontal health', 'serious cardiovascular adverse events', 'vascular biomarkers', 'reduction in vascular inflammation', 'inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332392', 'cui_str': 'pT2 category'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",30.0,0.258351,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Seinost', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria. Electronic address: gerald.seinost@medunigraz.at.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Horina', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Arefnia', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kulnik', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kerschbaumer', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Quehenberger', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Muster', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gütl', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Sieglinde', 'Initials': 'S', 'LastName': 'Zelzer', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mangge', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Reingard', 'Initials': 'R', 'LastName': 'Aigner', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Wimmer', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.09.019']
3088,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE


To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS


We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS


The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION


To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
3089,32871328,Outcomes following revascularization with radial artery bypass grafts: Insights from the PREVENT-IV trial.,"BACKGROUND


The optimal role of radial artery grafts in coronary artery bypass grafting (CABG) remains uncertain. The purpose of this study was to examine angiographic and clinical outcomes following CABG among patients who received a radial artery graft.
METHODS


Patients in the angiographic cohort of the PREVENT-IV trial were stratified based upon having received a radial artery graft or not during CABG. Baseline characteristics and 1-year angiographic and 5-year clinical outcomes were compared between patients.
RESULTS


Of 1,923 patients in the angiographic cohort of PREVENT-IV, 117 received a radial artery graft. These patients had longer surgical procedures (median 253 vs 228 minutes, P < .001) and had a greater number of grafts placed (P < .0001). Radial artery grafts had a graft-level failure rate of 23.0%, which was similar to vein grafts (25.2%) and higher than left internal mammary artery grafts (8.3%). The hazard of the composite clinical outcome of death, myocardial infarction, or repeat revascularization was similar for both cohorts (adjusted hazard ratio 0.896, 95% CI 0.609-1.319, P = .58). Radial graft failure rates were higher when used to bypass moderately stenotic lesions (<75% stenosis, 37% failure) compared with severely stenotic lesions (≥75% stenosis, 15% failure).
CONCLUSIONS


Radial artery grafts had early failure rates comparable to saphenous vein and higher than left internal mammary artery grafts. Use of a radial graft was not associated with a different rate of death, myocardial infarction, or postoperative revascularization. Despite the significant potential for residual confounding associated with post hoc observational analyses of clinical trial data, these findings suggest that when clinical circumstances permit, the radial artery is an acceptable alternative to saphenous vein and should be used to bypass severely stenotic target vessels.",2020,"Radial graft failure rates were higher when used to bypass moderately stenotic lesions (<75% stenosis, 37% failure) compared with severely stenotic lesions (≥75% stenosis, 15% failure).
","['1,923 patients in the angiographic cohort of PREVENT-IV', 'Patients in the angiographic cohort of the PREVENT-IV trial were stratified based upon having received a', 'patients who received a radial artery graft']","['radial artery graft', 'CABG', 'coronary artery bypass grafting (CABG', 'revascularization with radial artery bypass grafts', 'radial artery grafts', 'radial artery graft or not during CABG']","['Radial graft failure rates', 'Baseline characteristics and 1-year angiographic and 5-year clinical outcomes', 'number of grafts placed', 'longer surgical procedures', 'death, myocardial infarction, or repeat revascularization', 'graft-level failure rate', 'rate of death, myocardial infarction, or postoperative revascularization', 'failure rates', 'severely stenotic lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0185098', 'cui_str': 'Bypass graft'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.476261,"Radial graft failure rates were higher when used to bypass moderately stenotic lesions (<75% stenosis, 37% failure) compared with severely stenotic lesions (≥75% stenosis, 15% failure).
","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ranney', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Judson B', 'Initials': 'JB', 'LastName': 'Williams', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA; WakeMed Clinical Research Institute, Raleigh, NC, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mario F L', 'Initials': 'MFL', 'LastName': 'Gaudino', 'Affiliation': 'Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Habib', 'Affiliation': 'The Society of Thoracic Surgeons Research Center, Chicago, IL, USA.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Beth Israel Deaconess Medical Center, Cardiovascular Division, Boston, MA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Schwann', 'Affiliation': 'University of Massachusetts-Baystate, Springfield, MA, USA.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}]",American heart journal,['10.1016/j.ahj.2020.08.001']
3090,32882569,New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials.,"BACKGROUND


Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients.
METHODS


We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization.
RESULTS


The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001).
CONCLUSIONS


Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.",2020,"The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001).","['Patients aged ≥80\u202fyears', 'versus younger patients', 'octogenarians']","['octogenarians treated with new-generation DES', 'new-generation drug-eluting stents (DES', 'New-generation drug-eluting coronary stents']","['target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization', 'MI or target vessel revascularization rates', 'TVF', 'major bleeding risk', 'major bleeding', 'comorbidities', 'repeat target vessel revascularization', 'target vessel MI', 'risk of cardiac death', 'Cardiac mortality', 'cardiac death rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028829', 'cui_str': 'Octogenarians'}]","[{'cui': 'C0028829', 'cui_str': 'Octogenarians'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",9204.0,0.395704,"The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001).","[{'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Department of Cardiology, Rambam Medical Center, Technion, Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Benit', 'Affiliation': 'Department of Cardiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Diedrik G', 'Initials': 'DG', 'LastName': 'Buiten', 'Affiliation': 'Department of Psychiatry, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.07.003']
3091,32937053,Drone Delivery of an Automated External Defibrillator.,,2020,,[],['Automated External Defibrillator'],[],[],"[{'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}]",[],,0.0137706,,"[{'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC wayne_rosamond@unc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC wayne_rosamond@unc.edu.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Bogle', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC wayne_rosamond@unc.edu.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Arnold', 'Affiliation': 'North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cunningham', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Picinich', 'Affiliation': 'North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Billy M', 'Initials': 'BM', 'LastName': 'Williams', 'Affiliation': 'North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Zègre-Hemsey', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",The New England journal of medicine,['10.1056/NEJMc1915956']
3092,30895515,Accuracy of blood glucose measurements using the NOVA StatStrip® glucometer during cardiac surgery: a prospective observational study.,"PURPOSE


The Nova StatStrip® Glucose Hospital Meter System (Nova Biomedical, Waltham, MA, USA) is United States Food and Drug Administration approved for point-of-care use in critically ill patients, but its use during cardiac surgery has not been evaluated. In this study, we compare glucose values obtained during cardiac surgery by StatStrip® with values obtained by a blood gas analyzer.
METHODS


Blood glucose concentrations were analyzed in 121 patients by the StatStrip point- of-care test (POCT) glucose monitor and the GEM® Premier™ 3000 blood gas analyzer (Instrumentation Laboratory Company, Bedford MA, USA). Arterial blood samples were taken at baseline (before surgery), before cardiopulmonary bypass (CPB), during early and late CPB, and 30 min after CPB. Accuracy of the StatStrip glucometer was analyzed using the Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 criteria (criterion 1; 95% of samples should be ± 0.66 mMol·L -1  of reference glucose values < 5.5 mMol·L -1  and ± 12.5% for reference glucose values > 5.5 mMol·L -1 , criterion 2; 98% of samples should be ± 0.83 mMol·L -1  of reference glucose values < 4.1 mMol·L -1  or 20% of the reference glucose for values > 4.1 mMol·L -1 ).
RESULTS


The accuracy of StatStrip glucose measurements at baseline (99%, 100%) and before CPB (95%, 98%), but not during (early: 84%, 97%; late: 83%, 96%) and after (92%, 100%) CPB, satisfied the CLSI POCT12-A3 criteria.
CONCLUSION


Arterial blood glucose measurement by StatStrip was accurate before CPB, but lacked accuracy during and after CPB. Glucose values should be interpreted with caution when intensive glucose control protocols are being used during cardiac surgery.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02729064); registered 5 April, 2016.",2019,"The accuracy of StatStrip glucose measurements at baseline (99%, 100%) and before CPB (95%, 98%), but not during (early: 84%, 97%; late: 83%, 96%) and after (92%, 100%) CPB, satisfied the CLSI POCT12-A3 criteria.
CONCLUSION


","['cardiac surgery', 'critically ill patients', '121 patients by the StatStrip point- of-care test (POCT) glucose monitor and the GEM® Premier™ 3000 blood gas analyzer (Instrumentation Laboratory Company, Bedford MA, USA']",['NOVA StatStrip® glucometer'],"['Arterial blood glucose measurement', 'blood glucose measurements', 'Arterial blood samples', 'accuracy of StatStrip glucose measurements']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0444253', 'cui_str': 'Arterial blood specimen'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0529521,"The accuracy of StatStrip glucose measurements at baseline (99%, 100%) and before CPB (95%, 98%), but not during (early: 84%, 97%; late: 83%, 96%) and after (92%, 100%) CPB, satisfied the CLSI POCT12-A3 criteria.
CONCLUSION


","[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakadate', 'Affiliation': 'Department of Anesthesiology, University of Yamanashi, 1110 Shimokato, Chuo-city, Yamanashi, 409-3898, Japan. ynakadate@yamanashi.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesia, Royal Victoria Hospital, McGill University Health Centre Glen Site, Montreal, QC, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roque', 'Affiliation': 'School of Human Nutrition, McGill University, Ste-Anne-de-Bellevue, QC, Canada.'}, {'ForeName': 'Tamaki', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesia, Royal Victoria Hospital, McGill University Health Centre Glen Site, Montreal, QC, Canada.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Anesthesiology, University of Yamanashi, 1110 Shimokato, Chuo-city, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wykes', 'Affiliation': 'School of Human Nutrition, McGill University, Ste-Anne-de-Bellevue, QC, Canada.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kawakami', 'Affiliation': 'Department of Anesthesia, Royal Victoria Hospital, McGill University Health Centre Glen Site, Montreal, QC, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schricker', 'Affiliation': 'Department of Anesthesia, Royal Victoria Hospital, McGill University Health Centre Glen Site, Montreal, QC, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01350-7']
3093,31100353,Primary IOL implantation in children: the effect of the Infant Aphakia Treatment Study on practice patterns.,"We report the long-term effects on practice patterns at a single institution before (1995-2004) and after (2009-2018) publication of the results of the Infant Aphakia Treatment Study (IATS). The medical records of children <7 months of age who underwent cataract surgery at the Medical University of South Carolina were reviewed. The main outcome measure was the treatment with primary IOL or primary aphakia at the time of surgery. A total of 273 eyes of 183 patients were analyzed. Of the unilaterally affected eyes, primary IOL was the treatment of choice in 28 of the pre-IATS cases (61%) and 3 of the post-IATS cases (6%). In bilaterally affected eyes, primary IOL was the treatment of choice in 18 of the pre-IATS cases (47%) and 11 of the post-IATS cases (23%). According to a year-wise calculation, treatment with primary IOL began to decrease in 2010 and 2011, following publication of the 1-year results of the IATS in 2010. A drastic decrease in primary IOL occurred in 2015, following publication of the 5-year results.",2019,"Of the unilaterally affected eyes, primary IOL was the treatment of choice in 28 of the pre-IATS cases (61%) and 3 of the post-IATS cases (6%).","['children', 'A total of 273 eyes of 183 patients were analyzed', 'children <7\xa0months of age who underwent cataract surgery at the Medical University of South Carolina were reviewed']",['Primary IOL implantation'],"['primary IOL or primary aphakia at the time of surgery', 'primary IOL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",183.0,0.0319997,"Of the unilaterally affected eyes, primary IOL was the treatment of choice in 28 of the pre-IATS cases (61%) and 3 of the post-IATS cases (6%).","[{'ForeName': 'Zachary B', 'Initials': 'ZB', 'LastName': 'Poole', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Rupal H', 'Initials': 'RH', 'LastName': 'Trivedi', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina. Electronic address: wilsonme@musc.edu.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2018.12.013']
3094,31394914,Polysomnographic Endotyping to Select Patients with Obstructive Sleep Apnea for Oral Appliances.,"Rationale:  Oral appliance therapy is efficacious in many patients with obstructive sleep apnea (OSA), but prediction of treatment outcome is challenging. Small, detailed physiological studies have identified key OSA endotypic traits (pharyngeal collapsibility and loop gain) as determinants of greater oral appliance efficacy. Objectives:  We used a clinically applicable method to estimate OSA traits from routine polysomnography and identify an endotype-based subgroup of patients expected to show superior efficacy. Methods:  In 93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h), we examined whether polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal) were associated with oral appliance efficacy (percentage reduction in AHI from baseline) and could predict responses to treatment. Multivariable regression (with interactions) defined endotype-based subgroups of ""predicted"" responders and nonresponders (based on 50% reduction in AHI). Treatment efficacy was compared between the predicted subgroups (with cross-validation). Results:  Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003). Predicted responders ( n  = 54), compared with predicted nonresponders ( n  = 39), exhibited a greater reduction in AHI from baseline (mean [95% confidence interval], 73% [66-79] vs. 51% [38-61];  P  < 0.0001) and a lower treatment AHI (8 [6-11] vs. 16 [12-20] events/h;  P  = 0.002). Differences persisted after adjusting for clinical covariates (including baseline AHI, body mass index, and neck circumference). Conclusions:  Quantifying OSA traits using clinical polysomnography can identify an endotype-based subgroup of patients that is highly responsive to oral appliance therapy. Prospective validation is warranted.",2019,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003).","['93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h', 'many patients with obstructive sleep apnea (OSA', 'Patients with Obstructive Sleep Apnea for Oral Appliances']",['Oral appliance therapy'],"['Greater oral appliance efficacy', 'Treatment efficacy', 'favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation', 'polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",,0.03276,"Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall  R 2  = 0.30; adjusted  R 2  = 0.19;  P  = 0.003).","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Bamagoos', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Cistulli', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sutherland', 'Affiliation': 'Sleep Research Group, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Madronio', 'Affiliation': 'Centre for Sleep Health and Research, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Sleep and Breathing Lab, Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hess', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, and.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201903-190OC']
3095,31419913,Responses to a Daughter's Question about Prognosis When the Patient Is Expected to Die: A Qualitative Analysis.,,2019,,[],[],[],[],[],[],,0.0392027,,"[{'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Vasher', 'Affiliation': 'Johns Hopkins UniversityBaltimore, Maryland.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Zaeh', 'Affiliation': 'Johns Hopkins UniversityBaltimore, Maryland.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Eakin', 'Affiliation': 'Johns Hopkins UniversityBaltimore, Maryland.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Johns Hopkins UniversityBaltimore, Maryland.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201906-435RL']
3096,31440235,Modifications of the Transcriptomic Profile of Autoreactive B Cells From Pemphigus Patients After Treatment With Rituximab or a Standard Corticosteroid Regimen.,"Pemphigus Vulgaris is an autoimmune disease of the skin and mucous membranes, which is due to the production of pathogenic autoantibodies targeting desmoglein (DSG) 1 and 3, which are adhesion proteins of the keratinocytes. Rituximab is an anti-CD20 mAb which induces a prolonged depletion of blood B cells. We recently showed that rituximab was more effective than a standard oral corticosteroid (CS) treatment, allowing 90% of patients to achieve complete remission (CR). Additionally, we showed that DSG-specific-B (DSG positive) cells were still detectable during the B cell recovery which follows the initial rituximab-induced B cell depletion, even in patients in CR. In order to characterize DSG positive B cells in patients in CR after rituximab or CS treatment relative to those detectable at baseline in patients with an active pemphigus, we studied the expression profile of 31 genes of interest related to inflammatory cytokines, TNF receptors and activation markers. Using quantitative Polymerase Chain Reaction performed on one cell with a microfluidic technique, we found that patients' autoreactive B cells collected at baseline had a significantly higher expression of genes encoding for IL-1β, IL-23p19, and IL-12p35 pro-inflammatory cytokines and the IRF5 transcription factor, than non-autoreactive B cells. Surprisingly, the gene expression profile of DSG positive B cells collected after rituximab treatment in patients in CR was close to that of DSG positive B cells at baseline in patients with active pemphigus, except for the IL-1β and the CD27 memory marker genes, which were under-expressed after rituximab compared to baseline. Conversely, we observed a decreased expression of genes encoding for IL-1β and IL-23p19 in patients treated with CS relative to baseline. This study showed that: (i) DSG positive autoreactive B cells have a different gene expression profile than non-autoreactive B cells; (ii) rituximab and CS have different effects on the genes' expression in autoreactive DSG positive B cells from pemphigus patients.",2019,"Conversely, we observed a decreased expression of genes encoding for IL-1β and IL-23p19 in patients treated with CS relative to baseline.",['Autoreactive B Cells From Pemphigus Patients'],"['standard oral corticosteroid (CS', 'Rituximab', 'rituximab']","['DSG-specific-B (DSG positive) cells', 'complete remission (CR', 'gene expression profile of DSG positive B cells', 'expression of genes encoding for IL-1β and IL-23p19']","[{'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0113216', 'cui_str': 'Desmoglein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1311140', 'cui_str': 'IL-23 p19'}]",1.0,0.0905965,"Conversely, we observed a decreased expression of genes encoding for IL-1β and IL-23p19 in patients treated with CS relative to baseline.","[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hébert', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Petit', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Maho-Vaillant', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Golinski', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Riou', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Derambure', 'Affiliation': 'INSERM U1245, Normandie University, Rouen, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Boyer', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Calbo', 'Affiliation': 'INSERM U1234, Normandie University, Rouen, France.'}]",Frontiers in immunology,['10.3389/fimmu.2019.01794']
3097,31453722,"The Association between Prehospital Vulnerability, ARDS Development, and Mortality among At-Risk Adults. Results from the LIPS-A Clinical Trial.","Rationale:  No previous studies have examined the role of prehospital vulnerability in acute respiratory distress syndrome (ARDS) development and mortality in an acutely ill adult population. Objectives:  To describe the association between prehospital vulnerability and  1 ) the development of ARDS,  2 ) 28-day mortality, and  3 ) 1-year mortality. Methods:  This was a longitudinal prospective cohort study nested within the multicenter LIPS-A (Lung Injury Prevention Study-Aspirin) trial. We analyzed 301 participants who completed Vulnerable Elders Survey (VES) at baseline. Multivariable logistic regression and Cox regression analyses were used to describe the association between vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality), respectively. Results:  The VES score ranged from 0 to 10 (median [interquartile range], 2.0 [0-6]); 143 (47.5%) fit criteria for prehospital vulnerability (VES ≥ 3). Vulnerability was not significantly associated with ARDS development (10 [7.0%] vulnerable patients developed ARDS as per LIPS-A study criteria vs. 20 [12.7%] without vulnerability;  P  = 0.10; adjusted odds ratio [95% confidence interval (CI)], 0.54 [0.24-1.24];  P  = 0.15). Nor was vulnerability associated with 28-day mortality (15 [10.5%] vulnerable patients were dead by Day 28 vs. 11 [7.0%] nonvulnerable patients;  P  = 0.28; adjusted odds ratio [95% CI], 0.95 [0.39-2.26];  P  = 0.90). Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02). Conclusions:  In a population of adults recruited for their high risk of ARDS, prehospital vulnerability, measured by VES, was highly prevalent and strongly associated with 1-year mortality.",2019,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02).","['acutely ill adult population', '301 participants who completed Vulnerable Elders Survey (VES) at baseline']",[],"['ARDS development', 'Vulnerability', 'vulnerability and short-term outcomes (ARDS and 28-day mortality) and long-term outcomes (1-year mortality', '1-year mortality', '28-day mortality', 'VES score', 'Prehospital Vulnerability, ARDS Development, and Mortality', 'ARDS,  2 ) 28-day mortality, and  3 ) 1-year mortality', '1-year mortality in hospital survivors']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",301.0,0.201061,"Vulnerability was significantly associated with 1-year mortality in hospital survivors (35 [26.9%] vs. 13 [9.3%]; adjusted hazard ratio [95% CI], 2.20 [1.10-4.37];  P  = 0.02).","[{'ForeName': 'Aluko A', 'Initials': 'AA', 'LastName': 'Hope', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jen-Ting', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Talmor', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Department of Anesthesiology and.'}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201902-116OC']
3098,33029683,"Video discharge instructions for pediatric gastroenteritis in an emergency department: a randomized, controlled trial.","The aim was to evaluate if the addition of video discharge instructions (VDIs) to usual verbal information improved the comprehension of information provided to caregivers of patients who consult for acute gastroenteritis (AGE). We conducted an open-label, parallel, randomized trial, enrolling patients who consulted for AGE at a tertiary hospital. First, caregivers answered a written test concerning AGE characteristics and management. They were randomly allocated to a control group, which received the usual verbal instructions, or to an intervention group, which additionally received VDI. After discharge, caregivers were contacted by telephone and answered the same test, satisfaction questions, and follow-up information. From September 2019 to March 2020, 139 patients were randomized, 118 completed follow-up. The mean score was 3.13 (SD 1.07) over 5 points in the initial test and 3.96 (SD 0.96) in the follow-up test. Patients in the intervention group had a greater improvement (1.17 points, SD 1.11) than those in the control group (0.47 points, SD 0.94, p < 0.001). In the follow-up test, 49.1% in the intervention group and 18.6% in the control group answered all questions correctly (p < 0.001). There were no significant differences in return visits. Caregivers gave high satisfaction scores regardless of the allocation group.Conclusion: Video instructions improve caregivers' understanding of discharge information.Trial registration: [NCT04463355, retrospectively registered July 9, 2020]. What is Known: • Poor comprehension of discharge instructions leads to incorrect treatment after discharge, increased readmissions and a reduction of caregivers' satisfaction. • Video discharge instructions are useful providing concise information independently of the patients' health literacy level or communication skills of the health care provider What is New: • The addition of video discharge instructions to verbal instructions improves caregivers' knowledge about AGE improved with respect to those who only receive verbal instructions • Video instructions do not add extra time to the emergency department visits.",2020,"Patients in the intervention group had a greater improvement (1.17 points, SD 1.11) than those in the control group (0.47 points, SD 0.94, p < 0.001).","['pediatric gastroenteritis in an emergency department', 'enrolling patients who consulted for AGE at a tertiary hospital', 'caregivers of patients who consult for acute gastroenteritis (AGE', 'From September 2019 to March 2020, 139 patients were randomized, 118 completed follow-up']","['usual verbal instructions, or to an intervention group, which additionally received VDI', 'Video discharge instructions', 'video discharge instructions (VDIs']","['mean score', 'return visits']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332156', 'cui_str': 'Return to'}]",139.0,0.147632,"Patients in the intervention group had a greater improvement (1.17 points, SD 1.11) than those in the control group (0.47 points, SD 0.94, p < 0.001).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jové-Blanco', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Solís-García', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain. gonzalo.solis@salud.madrid.org.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Torres-Soblechero', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Escobar-Castellanos', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mora-Capín', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rivas-García', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Castro-Rodríguez', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marañón', 'Affiliation': ""Pediatric Emergency Department, Hospital General Universitario Gregorio Marañón, C/O'Donell 48, 28009, Madrid, Spain.""}]",European journal of pediatrics,['10.1007/s00431-020-03827-w']
3099,33029705,Folinic Acid as Adjunctive Therapy in Treatment of Inappropriate Speech in Children with Autism: A Double-Blind and Placebo-Controlled Randomized Trial.,"This is a double-blind, placebo-controlled randomized trial to investigate the potential therapeutic effects of folinic acid/placebo as an adjuvant to risperidone on inappropriate speech and other behavioral symptoms of autism spectrum disorder (ASD). Fifty-five ASD children (age (mean ± standard deviation) = 13.40 ± 2.00; male/female: 35/20) were evaluated for behavioral symptoms at baseline, week 5, and week 10 using the aberrant behavior checklist-community (ABC-C). Folinic acid dosage was 2 mg/kg up to 50 mg per day for the entire course of the study. The repeated measures analysis showed significant effect for time × treatment interaction on inappropriate speech (F = 3.51; df = 1.61; P = 0.044), stereotypic behavior (F = 4.02; df = 1.37; P = 0.036), and hyperactivity/noncompliance (F = 6.79; df = 1.66; P = 0.003) subscale scores. In contrast, no significant effect for time × treatment interaction was found on lethargy/social withdrawal (F = 1.06; df = 1.57; P = 0.336) and irritability (F = 2.86; df = 1.91; P = 0.064) subscale scores. Our study provided preliminary evidence suggesting that folinic acid could be recommended as a beneficial complementary supplement for alleviating speech and behavioral symptoms in children with ASD.Clinical trial registeration: This trial was registered in the Iranian Registry of Clinical Trials ( www.irct.ir ; No. IRCT20090117001556N114).",2020,"The repeated measures analysis showed significant effect for time × treatment interaction on inappropriate speech (F = 3.51; df = 1.61; P = 0.044), stereotypic behavior (F = 4.02; df = 1.37; P = 0.036), and hyperactivity/noncompliance (F = 6.79; df = 1.66; P = 0.003) subscale scores.","['autism spectrum disorder (ASD', 'Fifty-five ASD children (age (mean\u2009±\u2009standard deviation)\u2009=\u200913.40\u2009±\u20092.00; male/female: 35/20) were evaluated for behavioral symptoms at baseline, week 5, and week 10 using the aberrant behavior checklist-community (ABC-C', 'Children with Autism', 'children with ASD.Clinical trial registeration']","['folinic acid/placebo', 'folinic acid', 'placebo', 'risperidone', 'Folinic acid', 'Placebo', 'Folinic Acid']","['irritability', 'alleviating speech and behavioral symptoms', 'lethargy/social withdrawal', 'stereotypic behavior', 'hyperactivity/noncompliance', 'inappropriate speech']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}]",55.0,0.218733,"The repeated measures analysis showed significant effect for time × treatment interaction on inappropriate speech (F = 3.51; df = 1.61; P = 0.044), stereotypic behavior (F = 4.02; df = 1.37; P = 0.036), and hyperactivity/noncompliance (F = 6.79; df = 1.66; P = 0.003) subscale scores.","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Batebi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein Sanjari', 'Initials': 'HS', 'LastName': 'Moghaddam', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hasanzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Fakour', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net.'}]",Child psychiatry and human development,['10.1007/s10578-020-01072-8']
3100,33029789,Effect of Supplemental Enteral Fish Oil on the Development of Psychological Complications in Critically Ill Multiple Trauma Patients: 6 Months Follow up.,"BACKGROUND


Posttraumatic Stress disorder (PTSD) is common in ICU patients. One of the factors that may be associated with development of PTSD is deficit intake of omega-3 poly unsaturated fatty acids (PUFA). In this manuscript, we evaluated the effect of omega 3 PUFA's, gamma linolenic acid (GLA) and micronutrients on the long term onset of PTSD in multiple trauma patients.
METHODS


This study randomized mechanically ventilated patients suffering from multiple trauma (n = 150) into 2 groups: a study and control group that received enteral feeding with or without fish oil. Fifty one patients were interviewed 6 month after discharge from ICU. The psychometric parameters of PTSD were assessed by questionnaires. The fatty acid composition of erythrocyte membranes was performed by homogenization of the cells in hexane - isopropanol.
RESULTS


No differences were found in baseline characteristics between the groups. Erythrocyte membrane composition showed significant higher concentrations of omega 3 fatty acids in the study group. Anxiety and depression symptoms were correlated with an increase in EPA on day 4 and 8 for depression and EPA on day 4 and DHA on day 8 for anxiety. Total omega 3 content was positively correlated with anxiety and depression as well. An inverse correlation was found between DHA and EPA in the treatment group and with the total omega 3 and DHA in the control group for IPQ questionnaire.
CONCLUSION


Administration of n-3 PUFA enriched diet during the ICU stay didn't prevent development of PTSD in trauma patients six months after discharge from ICU. This article is protected by copyright. All rights reserved.",2020,Anxiety and depression symptoms were correlated with an increase in EPA on day 4 and 8 for depression and EPA on day 4 and DHA on day 8 for anxiety.,"['mechanically ventilated patients suffering from multiple trauma (n = 150) into 2 groups', 'multiple trauma patients', 'ICU patients', 'Critically Ill Multiple Trauma Patients', 'Fifty one patients were interviewed 6 month after discharge from ICU']","['n-3 PUFA', ""omega 3 PUFA's, gamma linolenic acid (GLA) and micronutrients"", 'enteral feeding with or without fish oil', 'Supplemental Enteral Fish Oil']","['Anxiety and depression symptoms', 'Psychological Complications']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",150.0,0.0232287,Anxiety and depression symptoms were correlated with an increase in EPA on day 4 and 8 for depression and EPA on day 4 and DHA on day 8 for anxiety.,"[{'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Kagan', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, and Sackler School of Medicine, Tel Aviv University, Israel.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Mesilati-Stahy', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, and Sackler School of Medicine, Tel Aviv University, Israel.'}, {'ForeName': 'Pnina', 'Initials': 'P', 'LastName': 'Green', 'Affiliation': 'Laboratory of Nutrition and Metabolism Research, Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel-Aviv University, Rabin Medical Center-Beilinson Campus, Petah-Tikva 49100, Israel and Faculty of Agriculture, Rehovot, Jerusalem University, Israel.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Department of Intensive Care and Institute for Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva, and Sackler School of Medicine, Tel Aviv University, Israel.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2025']
3101,33029861,Long-term analysis of adalimumab in Japanese patients with moderate to severe hidradenitis suppurativa: Open-label phase 3 results.,"This phase 3, multicenter, open-label single-arm study evaluated adalimumab (ADA) in Japanese patients with moderate to severe hidradenitis suppurativa (HS). Fifteen patients received ADA 160 mg s.c. at week 0, 80 mg at week 2 and 40 mg at week 4 and every week thereafter. At any time after week 52, patients were given the option to receive 80 mg ADA every other week or remain on 40 mg every week. The primary end-point (achievement of HS Clinical Response [HiSCR] at week 24) and results up to week 24 were published previously. Secondary end-points included total abscess and inflammatory nodule (AN) count, 30% or more and 1 unit or more reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30), modified Sartorius score and quality of life (QoL). After 12 weeks of ADA treatment, the achievement rate in HiSCR was 86.7%; HiSCR achievement rate was sustained through week 52 at 66.7%. Improvements at week 12 were also seen in the proportion of patients achieving an AN count of 0-2; NRS30 response rate among the nine patients with a baseline NRS of 3 or more; mean decrease in modified Sartorius score (61.4); and QoL as assessed by Dermatology Life Quality Index and Treatment Satisfaction Questionnaire; these improvements were maintained through 52 weeks. Similar efficacy was observed when patients switched dosing from ADA 40 mg every week to ADA 80 mg every other week. There were no new safety findings with ADA 40 mg weekly dosing during the study, and no differences in safety were found between patients who switched to 80 mg ADA every other week and patients who remained on 40 mg every week. The results of this study indicate that long-term ADA treatment is effective and well tolerated in Japanese patients with moderate to severe HS.",2020,"There were no new safety findings with ADA 40 mg weekly dosing during the study, and no differences in safety were found between patients who switched to 80 mg ADA every other week and patients who remained on 40 mg every week.","['Japanese patients with moderate to severe hidradenitis suppurativa', 'Japanese patients with moderate to severe hidradenitis suppurativa (HS', 'Japanese patients with moderate to severe HS']","['adalimumab', 'adalimumab (ADA', 'ADA']","['NRS30 response rate', 'effective and well tolerated', 'modified Sartorius score', 'Dermatology Life Quality Index and Treatment Satisfaction Questionnaire', 'HS Clinical Response [HiSCR', 'achievement rate in HiSCR', 'HiSCR achievement rate', ""total abscess and inflammatory nodule (AN) count, 30% or more and 1\xa0unit or more reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30), modified Sartorius score and quality of life (QoL""]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0224434', 'cui_str': 'Structure of sartorius muscle'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241136', 'cui_str': 'Pain of skin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",9.0,0.0145339,"There were no new safety findings with ADA 40 mg weekly dosing during the study, and no differences in safety were found between patients who switched to 80 mg ADA every other week and patients who remained on 40 mg every week.","[{'ForeName': 'Akimichi', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Takagi Dermatological Clinic, Hokkaido, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ozawa', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Nakama', 'Initials': 'N', 'LastName': 'Takekuni', 'Affiliation': 'Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'University of Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsuyama', 'Affiliation': 'Tokai University, Tokyo, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'AbbVie GK, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Kitamura', 'Affiliation': 'AbbVie GK, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Takei', 'Affiliation': 'AbbVie GK, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yokoyama', 'Affiliation': 'AbbVie GK, Tokyo, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Terui', 'Affiliation': 'Nihon University School of Medicine, Tokyo, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15605']
3102,33029896,Clinical comparison of an electric-powered ionic toothbrush to a manual toothbrush in plaque reduction: randomized clinical trial.,"OBJECTIVES


This study aimed to evaluate the plaque removal efficacy of a newly-developed electric-powered ionic toothbrush vs. a manual toothbrush.
MATERIALS AND METHODS


Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I). After 2-minutes of brushing, all teeth surfaces were stained with a plaque staining solution, and blinded examiners performed scoring using the Rustogi Modification of the Navy Plaque Index. Plaque removal rate was calculated at the central incisors, first premolar, and first molar, as representative teeth, in the maxilla and mandibula. One week following Phase I, the same examinations were repeated in all subjects using another toothbrush (Phase II), as a cross-over design.
RESULTS


Electric ionic toothbrushes demonstrated a significantly higher plaque removal rate than manual toothbrushes in the premolar and molar areas (p < 0.05). However, in the central incisor area, no statistically significant difference was observed.
CONCLUSIONS


Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",2020,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",['Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I'],"['electric-powered ionic toothbrush', 'newly-developed electric-powered ionic toothbrush vs. a manual toothbrush']","['plaque removal efficacy', 'plaque removal rate', 'Plaque removal rate']","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.0143584,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ikawa', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Mizutani', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Sudo', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kano', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Akizuki', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Izumi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Iwata', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12475']
3103,33029913,Evaluation of the Efficacy of Musical Vibroacupuncture in Pain Relief: A Randomized Controlled Pilot Study.,"OBJECTIVES


To investigate if skin vibration employing consonant frequencies emitted by skin transducers attached to a combination of acupuncture points and according to musical harmony (musical chord) produces more significant pain relief compared to just a single frequency.
MATERIALS AND METHODS


Skin vibrostimulation produced by five electromagnet transducers was applied at five acupoints traditionally used to pain relief and anxiety in 13 pain-free healthy volunteers using the cold pressor test (CPT). The study consisted of three randomized sessions conducted on alternate days, with participants receiving either simultaneous frequencies of 32, 48, and 64 Hz that equate those used in a musical chord, hereby defined as musical vibroacupuncture (MVA), a single frequency of 32 Hz, set as vibroacupuncture (VA) and sham procedure (SP). CPT scores for pain thresholds and pain tolerance were assessed using repeated-measures ANOVAs. Pain intensity was evaluated using a numerical rating scale (NRS), while sensory and affective aspects of pain were rated using the short-form McGill Pain Questionnaire (SF-MPQ) and State-Trait Anxiety Inventory (STAI) Y-Form.
RESULTS


Pain thresholds did not vary significantly between trials. Pain tolerance scores were markedly higher in MVA compared to baseline (p = 0.0043) or SP (p = 0.006) but not for VA. Pain intensity for MVA also differed significantly from the baseline (p = 0.007) or SP (p = 0.027), but not for VA. No significant differences were found in SF-MPQ and STAI questionnaires.
CONCLUSIONS


These results suggest that MVA effectively increased pain tolerance and reduced pain intensity when compared with all groups, although not significant to the VA group.",2020,Pain tolerance scores were markedly higher in MVA compared to baseline (p = 0.0043) or SP (p = 0.006) but not for VA.,"['participants receiving either simultaneous frequencies of 32, 48, and 64', 'Pain Relief', '13 pain-free healthy volunteers using the']","['cold pressor test (CPT', 'vibroacupuncture (VA) and sham procedure (SP', 'MVA', 'Hz that equate those used in a musical chord, hereby defined as musical vibroacupuncture (MVA', 'Musical Vibroacupuncture']","['SF-MPQ and STAI questionnaires', 'pain tolerance and reduced pain intensity', 'Pain thresholds', 'pain relief', 'Pain intensity', 'CPT scores for pain thresholds and pain tolerance', 'Pain tolerance scores', 'numerical rating scale (NRS), while sensory and affective aspects of pain were rated using the short-form McGill Pain Questionnaire (SF-MPQ) and State-Trait Anxiety Inventory (STAI) Y-Form', 'Pain intensity for MVA', 'pain relief and anxiety']","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0243150', 'cui_str': 'affective aspects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0765823,Pain tolerance scores were markedly higher in MVA compared to baseline (p = 0.0043) or SP (p = 0.006) but not for VA.,"[{'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'School of Computing, Engineering and Mathematics, University of Brighton, Brighton, East Sussex, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Busbridge', 'Affiliation': 'School of Computing, Engineering and Mathematics, University of Brighton, Brighton, East Sussex, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Governo', 'Affiliation': 'Brighton and Sussex Medical School (BSMS), University of Sussex, Brighton, East Sussex, UK.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13281']
3104,33029953,Biopharmaceutical Characteristics of Nifurtimox Tablets for Age- and Body Weight-Adjusted Dosing in Patients With Chagas Disease.,"Treatment of Chagas disease with nifurtimox requires age- and body weight-adjusted dosing, resulting in complex dosing instructions. Appropriate formulations are needed for precise and compliant dosing, especially in pediatric patients. We characterized the biopharmaceutical features of a standard nifurtimox 120-mg tablet and a 30-mg tablet developed to improve dose accuracy. Two open-label, randomized crossover studies were conducted in adult outpatients with Chagas disease. One study investigated whether 4 × 30-mg tablets and 1 × 120-mg tablet were bioequivalent and whether tablets can be administered as an aqueous slurry without affecting bioavailability. The second study investigated the effect of a high-calorie/high-fat diet versus fasting on the absorption of nifurtimox after a single 4 × 30-mg dose. Interventions were equivalent if the 90% confidence interval (CI) of their least-squares (LS) mean ratios for both AUC 0-tlast  and C max  were in the range of 80%-125%. The 4 × 30-mg and 1 × 120-mg tablet doses were bioequivalent (AUC 0-tlast  : LS mean ratio, 104.7%; 90%CI, 99.1%-110.7%; C max  : LS mean ratio, 101.7%; 90%CI, 89.4%-115.6%; n = 24). Exposure when giving the 4 × 30-mg dose as a slurry or as tablets was comparable, with an AUC 0-tlast  ratio of 93.2% (84.2%-103.1%; n = 12) and a slightly decreased C max  ratio for the slurry of 76.5% (68.8%-85.1%). Food improved the bioavailability of nifurtimox substantially (AUC 0-tlast  ratio fed/fasted  , 172%; 90%CI, 154%-192%; C max  ratio fed/fasted  , 168%; 90%CI, 150%-187%). The data indicate that the 30- and 120-mg tablets are suitable for dosing adult and pediatric patients accurately; nifurtimox should be administered under fed conditions.",2020,"Food improved the bioavailability of nifurtimox substantially (AUC 0-tlast  ratio fed/fasted  , 172%; 90%CI, 154%-192%; C max  ratio fed/fasted  , 168%; 90%CI, 150%-187%).","['adult outpatients with Chagas disease', 'pediatric patients', 'Patients With Chagas Disease']",['high-calorie/high-fat diet versus fasting'],"['bioavailability of nifurtimox', 'C max  ratio']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0028073', 'cui_str': 'Nifurtimox'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0327386,"Food improved the bioavailability of nifurtimox substantially (AUC 0-tlast  ratio fed/fasted  , 172%; 90%CI, 154%-192%; C max  ratio fed/fasted  , 168%; 90%CI, 150%-187%).","[{'ForeName': 'Heino', 'Initials': 'H', 'LastName': 'Stass', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Feleder', 'Affiliation': 'FP Clinical Pharma, Buenos Aires, Argentina.'}, {'ForeName': 'Facundo', 'Initials': 'F', 'LastName': 'Garcia-Bournissen', 'Affiliation': 'Division of Pediatric Clinical Pharmacology, Department of Pediatrics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Nagelschmitz', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Weimann', 'Affiliation': 'Chrestos Concept GmbH and Co. KG, Essen, Germany.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Yerino', 'Affiliation': 'FP Clinical Pharma, Buenos Aires, Argentina.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Altcheh', 'Affiliation': 'CONICET-GCBA, Hospital de Niños Ricardo Gutiérrez and Instituto Multidisciplinario de Investigación en Patologías Pediátricas, Buenos Aires, Argentina.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.871']
3105,33030089,COMT  Genotype and Efficacy of Propranolol for TMD Pain: A Randomized Trial.,"Propranolol is a nonselective β-adrenergic receptor antagonist that is efficacious in reducing facial pain. There is evidence that its analgesic efficacy might be modified by variants of the catechol-O-methyltransferase ( COMT ) gene. We tested the hypothesis in a subset of 143 non-Hispanic Whites from a randomized controlled trial of patients with painful temporomandibular disorder (TMD). Patients were genotyped for rs4680, a single nucleotide polymorphism of  COMT , and randomly allocated to either propranolol 60 mg twice daily or placebo. During the 9-wk follow-up period, patients recorded daily ratings of facial pain intensity and duration; the product was computed as an index of facial pain. Postbaseline change in the index at week 9 (the primary endpoint) was analyzed as a continuous variable and dichotomized at thresholds of ≥30% and ≥50% reduction. Mixed models for repeated measures tested for the genotype × treatment group interaction and estimated means, odds ratios (ORs), and 95% confidence limits (95% CLs) of efficacy within  COMT  genotypes assuming an additive genetic model. In secondary analysis, the cumulative response curves were plotted for dichotomized reductions ranging from ≥20% to ≥70%, and genotype differences in area under the curve percentages (%AUC) were calculated to signify efficacy. Mean index reduction did not differ significantly ( P  = 0.277) according to genotype, whereas the dichotomized ≥30% reduction revealed greater efficacy among G:G homozygotes (OR = 10.9, 95%CL = 2.4, 50.7) than among A:A homozygotes (OR = 0.8, 95%CL = 0.2, 3.2) with statistically significant interaction ( P  = 0.035). Cumulative response curves confirmed greater ( P  = 0.003) efficacy for G:G homozygotes (%AUC difference = 43.7, 95%CL = 15.4, 72.1) than for A:A homozygotes (%AUC difference = 6.5, 95%CL = -30.2, 43.2). The observed antagonistic effect of the A allele on propranolol's efficacy was opposite the synergistic effect hypothesized a priori. This unexpected result highlights the need for better knowledge of  COMT's  role in pain pathogenesis if the gene is to be used for precision-medicine treatment of TMD (ClinicalTrials.gov NCT02437383).",2020,"Cumulative response curves confirmed greater ( P  = 0.003) efficacy for G:G homozygotes (%AUC difference = 43.7, 95%CL = 15.4, 72.1) than for A:A homozygotes (%AUC difference = 6.5, 95%CL = -30.2, 43.2).","['patients with painful temporomandibular disorder (TMD', 'Patients were genotyped for rs4680, a single nucleotide polymorphism of  COMT', 'TMD Pain', '143 non-Hispanic Whites']","['Propranolol', 'propranolol 60 mg twice daily or placebo', 'G']","['facial pain', 'cumulative response curves', 'Mean index reduction', 'Cumulative response curves']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.318275,"Cumulative response curves confirmed greater ( P  = 0.003) efficacy for G:G homozygotes (%AUC difference = 43.7, 95%CL = 15.4, 72.1) than for A:A homozygotes (%AUC difference = 6.5, 95%CL = -30.2, 43.2).","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University at Buffalo, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hadgraft', 'Affiliation': 'Rho Inc., Durham, NC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Willis', 'Affiliation': 'Rho Inc., Durham, NC, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc., Durham, NC, USA.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Journal of dental research,['10.1177/0022034520962733']
3106,33030151,Career Crafting Training Intervention for Physicians: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Physicians work in a highly demanding work setting where ongoing changes affect their work and challenge their employability (ie, their ability and willingness to continue working). In this high-pressure environment, physicians could benefit from proactively managing or crafting their careers; however, they tend not to show this behavior. The new concept of career crafting concerns proactively making choices and adapting behavior regarding both short-term job design (ie, job crafting) as well as longer-term career development (ie, career self-management). However, so far, no intervention studies have aimed at enhancing career crafting behavior among physicians. Given that proactive work and career behavior have been shown to be related to favorable outcomes, we designed an intervention to support career crafting behavior and employability of physicians.
OBJECTIVE


The objectives of this study were to describe (1) the development and (2) the design of the evaluation of a randomized controlled career crafting intervention to increase job crafting, career self-management, and employability.
METHODS


A randomized controlled intervention study was designed for 141 physicians in two Dutch hospitals. The study was designed and will be evaluated based on parts of the intervention mapping protocol. First, needs of physicians were assessed through 40 interviews held with physicians and managers. This pointed to a need to support physicians in becoming more proactive regarding their careers as well as in building awareness of proactive behaviors in order to craft their current work situation. Based on this, a training program was developed in line with their needs. A number of theoretical methods and practical applications were selected as the building blocks of the training. Next, participants were randomly assigned to either the waitlist-control group (ie, received no training) or the intervention group. The intervention group participated in a 4-hour training session and worked on four self-set goals. Then, a coaching conversation took place over the phone. Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance. In addition, a process evaluation was conducted to examine factors that may have promoted or hindered the effectiveness of the intervention.
RESULTS


Data collection was completed in March 2020. Evaluation of outcomes and the research process started in April 2020. Study results were submitted for publication in September 2020.
CONCLUSIONS


This study protocol gives insight into the systematic development and design of a career crafting training intervention that is aimed to enhance job crafting, career self-management, and employability. This study will provide valuable information to physicians, managers, policy makers, and other researchers that aim to enhance career crafting.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18432.",2020,"Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance.",['141 physicians in two Dutch hospitals'],"['4-hour training session and worked on four self-set goals', 'waitlist-control group (ie, received no training', 'Career Crafting Training Intervention']","['changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0351807,"Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance.","[{'ForeName': 'Evelien H', 'Initials': 'EH', 'LastName': 'van Leeuwen', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Work and Organizational Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Knies', 'Affiliation': 'Utrecht University School of Governance, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Toon W', 'Initials': 'TW', 'LastName': 'Taris', 'Affiliation': 'Department of Social, Health and Organizational Psychology, Utrecht University, Utrecht, Netherlands.'}]",JMIR research protocols,['10.2196/18432']
3107,32894627,A randomised controlled trial addressing the impact of delivery mode after asymptomatic obstetric anal sphincter injury.,,2020,,['asymptomatic obstetric anal sphincter injury'],[],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}]",[],[],,0.149442,,"[{'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Tähtinen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cartwright', 'Affiliation': 'Department of Urogynaecology, Oxford University Hospitals NHS Trust, Oxford, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16486']
3108,33032331,Comparison of the Remineralizing Effect of Brushing with Aloe vera versus Fluoride Toothpaste.,"OBJECTIVES


The aim of the present  in vitro  study is to compare the remineralization brushing effect of three toothpastes and  Aloe vera  (AV) gel.
MATERIALS AND METHODS


Forty sound extracted teeth were placed in a demineralizing solution for 4 days and randomly assigned to four groups: group A: 1,450-ppm fluoride toothpaste; group B: AV nonfluoridated toothpaste; group C: AV 1,000-ppm fluoridated toothpaste; and group D: AV gel. A 3-minute pH cycling was performed twice a day for each group for 12 days. Specimens were analyzed before and after by scanning electron microscope-energy dispersive X-ray.
STATISTICAL ANALYSIS


The outcomes were analyzed by Kolmogorov-Smirnov's tests, repeated-measures analyses of variance followed by univariate analyses, and Bonferroni's multiple comparisons tests to compare the calcium-to-phosphorus (Ca:P) ratio within time among toothpaste groups.
RESULTS


Following remineralization, the Ca:P ratio increased in all groups. The difference of the Ca:P ratio was not significant between groups C, D, and A. The mean ratio was significantly lower in group B ( p -value = 0.026).
CONCLUSIONS


The AV gel demonstrated a remineralization capacity equal to that of the 1,450-ppm fluoride toothpaste. In contrast, fluoride-free AV toothpaste showed a lower remineralization efficiency. Further studies are required to understand its mechanism.",2020,"The AV gel demonstrated a remineralization capacity equal to that of the 1,450-ppm fluoride toothpaste.","['group B', 'Forty sound extracted teeth', 'group C']","['three toothpastes and  Aloe vera  (AV) gel', '1,450-ppm fluoride toothpaste', 'AV nonfluoridated toothpaste', 'Aloe vera versus Fluoride Toothpaste', 'AV 1,000-ppm fluoridated toothpaste', 'fluoride-free AV toothpaste']","['Ca:P ratio', 'calcium-to-phosphorus (Ca:P) ratio within time', 'remineralization efficiency', 'mean ratio']","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0974143', 'cui_str': 'Aloe vera gel'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0188431,"The AV gel demonstrated a remineralization capacity equal to that of the 1,450-ppm fluoride toothpaste.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Al Haddad', 'Affiliation': 'Department of Pediatric Dentistry, Saint Joseph University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Khoury', 'Affiliation': 'Department of Orthodontics, Saint Joseph University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Farhat Mchayleh', 'Affiliation': 'Department of Pediatric Dentistry, Saint Joseph University of Beirut, Beirut, Lebanon.'}]",European journal of dentistry,['10.1055/s-0040-1716597']
3109,33032451,An experimental investigation of the impact of rapport on Stroop test performance.,"Rapport in the context of neuropsychological testing refers to the level of interpersonal ease between examiner and examinee. However, scant research has examined the impact of rapport on neuropsychological test performance. The purpose of this between-subjects experiment was to investigate the impact of rapport on Stroop test performance. College students ( N  = 114) were randomly assigned to either a high or a low rapport condition and administered the D-KEFS Color-Word Interference Test. Individuals in the low rapport condition took longer to complete the Inhibition Trial of the Stroop test but did not vary on the Inhibition/Switching Trial. Low rapport may distract examinees, sapping attentional resources on the Inhibition Trial.",2020,Individuals in the low rapport condition took longer to complete the Inhibition Trial of the Stroop test but did not vary on the Inhibition/Switching Trial.,['College students ( N \u2009=\u2009114'],['low rapport condition and administered the D-KEFS Color-Word Interference Test'],['Stroop test performance'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",114.0,0.0370056,Individuals in the low rapport condition took longer to complete the Inhibition Trial of the Stroop test but did not vary on the Inhibition/Switching Trial.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barnett', 'Affiliation': 'University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sawyer', 'Affiliation': 'University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'University of Texas at Tyler, Tyler, TX, USA.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2020.1828081']
3110,33032471,Effect of  Bifidobacterium infantis  NLS super strain in symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study.,"Bifidobacterium infantis  NLS super strain ( B. infantis  NLS-SS) was previously shown to alleviate gastrointestinal symptoms in newly diagnosed coeliac disease (CD) patients consuming gluten. A high proportion of patients following a gluten-free diet experiences symptoms despite dietary compliance. The role of  B. infantis  in persistently symptomatic CD patients has not been explored. The aim of the study was to evaluate the effect of  B. infantis  NLS-SS on persistent gastrointestinal symptoms in patients with CD following a long-term GFD. We conducted a randomised, cross-over, double-blind, placebo-controlled trial in symptomatic adult CD patients on a GFD for at least two years. After one-week run-in, patients were randomised to  B. infantis  NLS-SS or placebo for 3 weeks with cross-over after a 2-week wash-out period. We estimated changes (Δ) in celiac symptom index (CSI) before and after treatment. Stool samples were collected for faecal microbiota analysis (16S rRNA sequencing). Gluten immunogenic peptide (GIP) excretion in stool and urine samples was measured at each study period. Eighteen patients were enrolled; six patients were excluded due violations in protocol. For patients with the highest clinical burden, CD symptoms were lower in probiotic than in placebo treatment ( P =0.046).  B. infantis  and placebo treated groups had different microbiota profiles as assessed by beta diversity clustering. In probiotic treated groups, we observed an increase in abundance of  B. infantis . Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis . GIP excretion in stools and urine was similar at each treatment period. There were no differences in adverse effects between the two groups.  B. infantis  NLS-SS improves specific CD symptoms in a subset of highly symptomatic treated patients (GFD). This is associated with a shift in stool microbiota profile. Larger studies are needed to confirm these findings. ClinicalTrials.gov: NCT03271138.",2020,Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis .,"['symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study', 'Eighteen patients were enrolled; six patients were excluded due violations in protocol', 'persistently symptomatic CD patients', 'symptomatic adult CD patients on a GFD for at least two years', 'patients with CD following a long-term GFD', 'newly diagnosed coeliac disease (CD) patients consuming gluten']","['Bifidobacterium infantis  NLS super strain ( B. infantis  NLS-SS', 'NLS-SS or placebo', 'B. infantis  NLS-SS', 'placebo', 'Bifidobacterium infantis  NLS super strain']","['CD symptoms', 'GIP excretion in stools and urine', 'adverse effects', 'abundance of  B. infantis ', 'microbiota profiles', 'celiac symptom index (CSI', 'specific CD symptoms', 'Gluten immunogenic peptide (GIP) excretion in stool and urine samples']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1851112', 'cui_str': 'Gingival fibromatosis with progressive deafness syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}]","[{'cui': 'C0314976', 'cui_str': 'Bifidobacterium Infantis'}, {'cui': 'C0265218', 'cui_str': 'Neu-Laxova syndrome'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",18.0,0.209674,Treatment with  B. infantis  was associated with decreased abundance of  Ruminococcus  sp. and  Bifidobacterium adolescentis .,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smecuol', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constante', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Temprano', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Costa', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Moreno', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pinto-Sanchez', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vázquez', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Stefanolo', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Gonzalez', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': ""D'Adamo"", 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD 21201, USA.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Niveloni', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mauriño', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Verdu', 'Affiliation': 'Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON L8S 4L8, Canada.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bai', 'Affiliation': 'Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, 1264 Buenos Aires, Argentina.'}]",Beneficial microbes,['10.3920/BM2020.0016']
3111,33032474,Clinical evaluation of the synbiotic Prodefen Plus® in the prevention of the antibiotic-associated diarrhoea in subjects requiring antibiotic treatment.,"Prodefen® is a dietary food supplement formulated as a synbiotic that has shown additional benefit to the standard supportive therapy in the management of acute viral diarrhoea in children. There is scarce evidence of this synbiotic in adults. The objective of this randomised double blind placebo-controlled clinical trial was to evaluate the efficacy and safety of Prodefen Plus® in the prevention of antibiotic-associated diarrhoea (AAD) in an adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation. 151 subjects were randomised to the active (synbiotic) or control arm (placebo) for 14 days. There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group. A higher reduction in both the frequency and duration of the diarrhoea episodes in the active group was also observed, as it was an improved perception of the diarrhoea severity. Overall, the study medication was well tolerated. In conclusion, results from this study confirm the beneficial effect of the synbiotic administered as adjuvant therapy in preventing the antibiotic-associated diarrhoea.",2020,"There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group.","['adults', '151 subjects', 'acute viral diarrhoea in children', 'subjects requiring antibiotic treatment', 'adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation']","['synbiotic', 'active (synbiotic) or control arm (placebo', 'placebo', 'Prodefen Plus®', 'synbiotic Prodefen Plus®']","['AAD incidence', 'efficacy and safety', 'diarrhoea severity', 'tolerated', 'stool consistency', 'frequency and duration of the diarrhoea episodes', 'antibiotic-associated diarrhoea (AAD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0152517', 'cui_str': 'Viral gastroenteritis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0555971', 'cui_str': 'Oral infection'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea'}]",151.0,0.159538,"There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group.","[{'ForeName': 'C Barreiro', 'Initials': 'CB', 'LastName': 'Guridi', 'Affiliation': 'Clínica Dental Dra. Coro Guridi Rodríguez, Av. Francisco de Goya 16, 50006 Zaragoza, Spain.'}, {'ForeName': 'A Romeo', 'Initials': 'AR', 'LastName': 'Serena', 'Affiliation': 'Clínica Dental Dra Marina Tarrío, Paseo de Calanda 1, 50010 Zaragoza, Spain.'}, {'ForeName': 'S Gallego', 'Initials': 'SG', 'LastName': 'Cabrera', 'Affiliation': 'Clínica Dental Gallego, Avinguda de Pérez Galdós 2, 46007 València, Spain.'}, {'ForeName': 'I Alaman', 'Initials': 'IA', 'LastName': 'Fernández', 'Affiliation': 'Maxiloimplant Clínica Dental, Calle de Guareña, 5, 28044 Madrid, Spain.'}, {'ForeName': 'C Royo', 'Initials': 'CR', 'LastName': 'Hernández', 'Affiliation': 'Clínica Dental Royo, Av. Oscar Espla 21, 03007 Alacant, Spain.'}, {'ForeName': 'B Martín', 'Initials': 'BM', 'LastName': 'Vivanco', 'Affiliation': 'Clínica Dental Beatriz Martín Vivanco, C/ Ana Albi 19 bajo, 28025 Madrid, Spain.'}, {'ForeName': 'M Cruz', 'Initials': 'MC', 'LastName': 'Melguizo', 'Affiliation': 'Clínica Dental Sonrisas, C. de la Princesa 90, piso 2°, 2ª, 28008 Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Suárez-Almarza', 'Affiliation': 'ITF Research Pharma S.L.U., Grupo Italfarmaco, Calle s San Rafael 3, 28108 Alcobendas, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'ITF Research Pharma S.L.U., Grupo Italfarmaco, Calle s San Rafael 3, 28108 Alcobendas, Spain.'}]",Beneficial microbes,['10.3920/BM2020.0062']
3112,33032564,The effect of an online exercise programme on bone health in paediatric cancer survivors (iBoneFIT): study protocol of a multi-centre randomized controlled trial.,"BACKGROUND


New approaches on paediatric cancer treatment aim to maintain long-term health. As a result of radiotherapy, chemotherapy or surgery, paediatric cancer survivors tend to suffer from any chronic health condition. Endocrine dysfunction represents one of the most common issues and affects bone health. Exercise is key for bone mass accrual during growth, specifically plyometric jump training. The iBoneFIT study will investigate the effect of a 9-month online exercise programme on bone health in paediatric cancer survivors. This study will also examine the effect of the intervention on body composition, physical fitness, physical activity, calcium intake, vitamin D, blood samples quality of life and mental health.
METHODS


A minimum of 116 participants aged 6 to 18 years will be randomized into an intervention (n = 58) or control group (n = 58). The intervention group will receive an online exercise programme and diet counselling on calcium and vitamin D. In addition, five behaviour change techniques and a gamification design will be implemented in order to increase the interest of this non-game programme. The control group will only receive diet counselling. Participants will be assessed on 3 occasions: 1) at baseline; 2) after the 9 months of the intervention; 3) 4 months following the intervention. The primary outcome will be determined by dual energy X-ray absorptiometry (DXA) and the hip structural analysis, trabecular bone score and 3D-DXA softwares. Secondary outcomes will include anthropometry, body composition, physical fitness, physical activity, calcium and vitamin D intake, blood samples, quality of life and mental health.
DISCUSSION


Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors. This article describes the design, rationale and methods of a study intended to test the effect of a rigorous online exercise programme on bone health in paediatric cancer survivors. If successful, the iBoneFIT study will contribute to decrease chronic health conditions in this population and will have a positive impact in the society.
TRIAL REGISTRATION


Prospectively registered in isrctn.com: isrctn61195625 . Registered 2 April 2020.",2020,"Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors.","['paediatric cancer survivors', 'paediatric cancer survivors (iBoneFIT', '116 participants aged 6 to 18\u2009years']","['online exercise programme and diet counselling on calcium and vitamin D', 'online exercise programme', 'radiotherapy, chemotherapy', 'diet counselling', 'rigorous online exercise programme']","['bone health', 'anthropometry, body composition, physical fitness, physical activity, calcium and vitamin D intake, blood samples, quality of life and mental health', 'body composition, physical fitness, physical activity, calcium intake, vitamin D, blood samples quality of life and mental health', 'dual energy X-ray absorptiometry (DXA) and the hip structural analysis, trabecular bone score and 3D-DXA softwares']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037585', 'cui_str': 'Software'}]",,0.179983,"Whether a simple, feasible and short in duration exercise programme can improve bone health has not been examined in paediatric cancer survivors.","[{'ForeName': 'Jose J', 'Initials': 'JJ', 'LastName': 'Gil-Cosano', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ubago-Guisado', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Sánchez', 'Affiliation': 'Andalusian School of Health (EASP), Granada, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Ortega-Acosta', 'Affiliation': 'Servicio de Pediatría y Oncohematología Pediátricas, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Mateos', 'Affiliation': 'Pediatric Oncology Unit, Department of Pediatrics, Reina Sofia University Hospital, Córdoba, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Benito-Bernal', 'Affiliation': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Llorente-Cantarero', 'Affiliation': 'Maimonides Institute for Research in Biomedicine of Cordoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Francisco B', 'Initials': 'FB', 'LastName': 'Ortega', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': ""Institute for Innovation and Sustainable Development in Food Chain (IS-FOOD), Navarra's Health Research Institute (IdiSNA), Department of Health Sciences, Public University of Navarra, Calle Tajonar 22, 31006, Pamplona, Navarra, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martinez-Vizcaino', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vlachopoulos', 'Affiliation': ""Children's Health and Exercise Research Centre, Sport and Health Sciences, University of Exeter, Exeter, UK.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Biohealth Research Institute in Granada (ibs.GRANADA), E-18012, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muñoz-Torres', 'Affiliation': 'Bone Metabolic Unit, Endocrinology and Nutrition Division, Hospital Universitario San Cecilio, Instituto de Investigación Biosanitaria de Granada (Ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Pascual-Gázquez', 'Affiliation': 'Servicio de Pediatría y Oncohematología Pediátricas, Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Vicho-González', 'Affiliation': 'Pediatric Oncology Unit, Department of Pediatrics, Reina Sofia University Hospital, Córdoba, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gracia-Marco', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, 18071, Granada, Spain. lgracia@ugr.es.'}]",BMC public health,['10.1186/s12889-020-09607-3']
3113,33032566,A protocol for a randomized controlled trial investigating the safety and cost-effectiveness of outpatient total hip arthroplasty.,"BACKGROUND


A significant proportion of the overall cost of total hip arthroplasty (THA) results from the inpatient hospital stay following the procedure. Considering the substantial and increasing number of these procedures performed annually, shifting to an outpatient model of care where the patient is discharged home the same day as their surgery represents a potential for significant cost savings. The potential significant impact of an outpatient care model on constrained healthcare budgets and lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this prospective, randomized controlled trial is to evaluate outpatient care pathways for THA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient THA.
METHODS


We will include patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight. Consenting patients will be randomized to be discharged on the same day as surgery, as outpatients, or as inpatients according to standard of care (minimum of one night in hospital) using a modified Zelen consent model. The primary outcome measure is the incidence of serious adverse events at 30 days postoperative. Participants and their caregivers will complete secondary outcomes measures at each follow-up visit including patient-reported outcome measures and self-reported cost questionnaires.
DISCUSSION


This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation. It is also the first adequately powered trial to prospectively assess the safety of outpatient THA. Successful completion of this study could have the potential to provide clinical evidence for the role of outpatient THA in current practice.
TRIAL REGISTRATION


This study was retrospectively registered on ClinicalTrials.gov ( NCT03026764 ) on March 9th, 2016.",2020,This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation.,"['patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight', 'Consenting patients']",['outpatient total hip arthroplasty'],"['incidence of serious adverse events', 'self-reported cost questionnaires', 'safety and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0997082,This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation.,"[{'ForeName': 'Bryn O', 'Initials': 'BO', 'LastName': 'Zomar', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Jacquelyn D', 'Initials': 'JD', 'LastName': 'Marsh', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Lanting', 'Affiliation': 'Bone and Joint Institute, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Faculty of Health Sciences, University of Western Ontario, London, ON, Canada. Dianne.bryant@uwo.ca.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03699-z']
3114,33032585,The effect of curcumin ointment on knee pain in older adults with osteoarthritis: a randomized placebo trial.,"BACKGROUND


Some studies have shown the effect of oral administration of curcumin on knee pain. However, limited studies are available on the effect of topical curcumin. This study aimed to investigate the effect of curcumin ointment on knee pain in older adults with osteoarthritis.
METHODS


This double-blind randomized placebo trial was conducted on 72 older adults with knee pain associated with osteoarthritis. The subjects were randomly assigned into an intervention and a placebo group to apply either curcumin 5% ointment or Vaseline ointment twice daily for 6 weeks. Using a Visual Analog Scale, the severity of knee pain was measured at the beginning of the study, at the end of the fourth and sixth week. Data were analyzed using descriptive and inferential methods.
RESULTS


The mean baseline knee pain intensity was not significantly different between the two groups (P = 0.15). The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02). The repeated-measures analysis showed that over time, the curcumin significantly decreased the mean pain intensity in the intervention group (P = 0.001). The mixed model showed an absolute difference of 1.133 (i.e. 11.33 mm) score which signifies a medium effect size and that the patient in the intervention group achieved the minimal clinically important difference.
CONCLUSION


Topical administration of curcumin 5% ointment can significantly reduce knee pain in older adults with knee osteoarthritis. Curcumin ointment can be used as an alternative treatment in older adults with knee pain associated with osteoarthritis.
TRIAL REGISTRATION


Retrospectively registered in the Iranian Registry of Clinical Trials (IRCT) (IRCT20100403003618N6, 2019-03-08), https://en.irct.ir/trial/37155.",2020,The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02).,"['older adults with knee pain associated with osteoarthritis', 'older adults with knee osteoarthritis', '72 older adults with knee pain associated with osteoarthritis', 'older adults with osteoarthritis']","['curcumin ointment', 'curcumin', 'placebo', 'Curcumin ointment', 'curcumin 5% ointment or Vaseline ointment']","['knee pain', 'mean baseline knee pain intensity', 'mean pain intensity', 'Visual Analog Scale, the severity of knee pain']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",72.0,0.228695,The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02).,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jamali', 'Affiliation': 'Trauma Nursing research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Adib-Hajbaghery', 'Affiliation': 'Trauma Nursing research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran. adib1344@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Internal Medicine Department, Kashan University of Medical Sciences, Kashan, Iran.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03105-0']
3115,33032612,Procalcitonin and lung ultrasound algorithm to diagnose severe pneumonia in critical paediatric patients (PROLUSP study). A randomised clinical trial.,"BACKGROUND


Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. We propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest X-ray (CXR).
METHODS/DESIGN


A 3-year clinical trial.
INCLUSION CRITERIA


children younger than 18 years old with suspected pneumonia in a Paediatric Intensive Care Unit. Patients will be randomised into two groups: Experimental Group: LUS will be performed as first lung image.
CONTROL GROUP


CXR will be performed as first pulmonary image. Patients will be classified according to the image and the PCT: a) PCT < 1 ng/mL and LUS/CXR are not suggestive of bacterial pneumonia (BN), no antibiotic will be prescribed; b) LUS/CXR are suggestive of BN, regardless of the PCT, antibiotic therapy is recommended; c) LUS/CXR is not suggestive of BN and PCT > 1 ng/mL, antibiotic therapy is recommended.
CONCLUSION


This algorithm will help us to diagnose bacterial pneumonia and to prescribe the correct antibiotic treatment. A reduction of antibiotics per patient, of the treatment length, and of the exposure to ionizing radiation and in costs is expected.
TRIAL REGISTRATION


NCT04217980 .",2020,"A reduction of antibiotics per patient, of the treatment length, and of the exposure to ionizing radiation and in costs is expected.
","['critical paediatric patients (PROLUSP study', 'children younger than 18\u2009years old with suspected pneumonia in a Paediatric Intensive Care Unit']","['Lung ultrasound (LUS', 'LUS and procalcitonin (PCT', 'Procalcitonin and lung ultrasound algorithm', 'LUS vs chest X-ray (CXR', 'GROUP']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.120549,"A reduction of antibiotics per patient, of the treatment length, and of the exposure to ionizing radiation and in costs is expected.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodríguez-Fanjul', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Paediatrics, Hospital Germans Trias i Pujol, Autonomous University of Barcelona, Badalona, Spain.'}, {'ForeName': 'Carmina', 'Initials': 'C', 'LastName': 'Guitart', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, University of Barcelona, P° Sant Joan de Déu, 2, 08950 Esplugues, Barcelona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bobillo-Perez', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, University of Barcelona, P° Sant Joan de Déu, 2, 08950 Esplugues, Barcelona, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Balaguer', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, University of Barcelona, P° Sant Joan de Déu, 2, 08950 Esplugues, Barcelona, Spain. mbalaguer@sjdhospitalbarcelona.org.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Jordan', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, University of Barcelona, P° Sant Joan de Déu, 2, 08950 Esplugues, Barcelona, Spain.'}]",Respiratory research,['10.1186/s12931-020-01476-z']
3116,33034639,Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial.,"Importance


Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown.
Objective


To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months.
Design, Setting, and Participants


This 4-group, randomized clinical trial was conducted from August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System. The study population included adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication. Data analysis was performed from July 2017 to June 2019.
Interventions


The interventions lasted 6 months during which all participants received daily medication reminders and an electronic pill bottle. Statin adherence was measured by opening the bottle. For participants randomized to the 3 intervention groups, adherence was rewarded with financial incentives. The sweepstakes group involved incentives for daily adherence. In the deadline sweepstakes group, incentives were reduced if participants were adherent only after a reminder. The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence.
Main Outcomes and Measures


The primary outcome was change in LDL-C level from baseline to 12 months.
Results


Among 805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease. The mean (SD) baseline LDL-C level was 143.2 (42.5) mg/dL. Measured adherence at 6 months (defined as the proportion of 180 days with electronic pill bottle opening) in the control group (0.69; 95% CI, 0.66-0.72) was lower than that in the simple sweepstakes group (0.84; 95% CI, 0.81-0.87), the deadline sweepstakes group (0.86; 95% CI, 0.83-0.89), and the sweepstakes plus deposit contract group (0.87; 95% CI, 0.84-0.90) (P < .001 for each incentive group vs control). LDL-C levels were measured for 636 participants at 12 months. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/dL (95% CI, 27.3-37.6 mg/dL) in the sweepstakes group, 33.2 mg/dL (95% CI, 28.1-38.3 mg/dL) in the deadline sweepstakes group, and 36.5 mg/dL (95% CI, 31.3-41.7 mg/dL) in the sweepstakes plus deposit contract group (adjusted P > .99 for each incentive group vs control).
Conclusions and Relevance


Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors.
Trial Registration


ClinicalTrials.gov Identifier: NCT01798784.",2020,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","['August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System', '636 participants at 12 months', '805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease', 'adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication']","['dL', 'daily medication reminders and an electronic pill bottle', 'Patient Financial Incentives']","['statin adherence', 'low-density lipoprotein cholesterol (LDL-C) levels', 'Statin Adherence and Lipid Control', 'Statin adherence', 'LDL-C levels', 'mean (SD) baseline LDL-C level', 'change in LDL-C level', 'Mean LDL-C level reductions']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",805.0,0.18507,"Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/","[{'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Barankay', 'Affiliation': 'Department of Management, The Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Louise B', 'Initials': 'LB', 'LastName': 'Russell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pagnotti', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McGilloway', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Troyen', 'Initials': 'T', 'LastName': 'Brennan', 'Affiliation': 'Department of Health Policy and Management, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts.'}, {'ForeName': 'Darra', 'Initials': 'D', 'LastName': 'Finnerty', 'Affiliation': 'Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoffer', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sakshum', 'Initials': 'S', 'LastName': 'Chadha', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.19429']
3117,33034651,"Evaluation of a Novel Decision Guide ""Go to the Hospital or Stay Here?"" for Nursing Home Residents and Families: A Randomized Trial.","Initiatives to reduce potentially preventable hospitalizations of nursing home residents have focused on staff response to changes in condition and advance care planning. Yet, resident and family insistence on transfer has been one of the most intractable sources of these hospitalizations, although not the target of active intervention until now. Consented residents and family members in the intervention group received a newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home. This person-centered decision aid was developed from the results of 271 interviews of residents, families, and providers to identify what they wanted to know and any misunderstandings surrounding the transfer process. Engaging residents in the decision respects their right to participate and provides the information they need to make a deliberative decision. The intervention group showed a gain in knowledge and reduction in decisional conflict but reported decreased decisional preparation. There was no decrease in transfers compared to the control group. Evaluation of the decision guide by residents and families was positive.
TARGETS


Nursing home residents and their family members.
INTERVENTION


To provide information regarding the decision to stay in the nursing home or transfer to acute care due to a change in condition.
MECHANISMS OF ACTION


Decision aid ""Go the ""Hospital or Stay Here?"" to impart knowledge regarding the decision to remain in the nursing home or transfer to acute care.
OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation. No reduction in transfers was found. Residents and families rated the Guide as very helpful. [Research in Gerontological Nursing, xx(x), xx-xx.].",2020,"OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","['Nursing Home Residents and Families', 'Nursing home residents and their family members']","['newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home']","['decisional preparation', 'transfers', 'gain in knowledge and reduction in decisional conflict', ""residents' and family members' knowledge and decrease decisional conflict""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0154065,"OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","[{'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Tappen', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Worch', 'Affiliation': ''}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hain', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20201002-01']
3118,33034707,The effect of olive leaf extract on cardiovascular health markers: a randomized placebo-controlled clinical trial.,"PURPOSE


Overweight and obesity are associated with many health problems, including cardiovascular disease (CVD). Evidence from previous studies has shown that extracts from olive leaves rich in olive phenolics are able to positively affect CVD risk factors, such as high blood pressure and dyslipidemia. The aim of this study was to investigate the effect of 8-week olive leaf extract (OLE) administration on blood lipid profiles in overweight/obese subjects with mildly elevated cholesterol levels.
METHODS


In this randomized, double-blind, placebo-controlled study, 77 healthy adult overweight/obese subjects (aged 56 ± 10 years and BMI 29.0 ± 2.7 kg/m 2 ) with total cholesterol levels of 5.0-8.0 mmol/L (5.9 ± 0.7 mmol/L) were randomly assigned to receive 500 mg of OLE (n = 39) or placebo (n = 38) for 8 weeks. In total, 74 subjects completed the entire study protocol. At baseline, after 4 weeks, and after 8 weeks of supplementation, blood lipid profiles, oxidized low-density lipoprotein (oxLDL), blood pressure, glucose, and insulin levels were assessed. In addition, liver function parameters were measured at baseline and after 8 weeks.
RESULTS


OLE supplementation did not significantly affect blood lipid levels after 4 weeks or after 8 weeks compared to placebo (all p > 0.05). For oxLDL, blood pressure, glucose, and insulin levels and liver function parameters, also no statistically significant differences were found between the two intervention groups (all p > 0.05).
CONCLUSIONS


Blood lipid profiles were not significantly affected by 8 weeks OLE supplementation in overweight/obese subjects with mildly elevated cholesterol levels.
TRIAL REGISTERED


The trial has been registered at ClinicalTrials.gov (NCT02990637).",2020,"RESULTS


OLE supplementation did not significantly affect blood lipid levels after 4 weeks or after 8 weeks compared to placebo (all p > 0.05).","['74 subjects completed the entire study protocol', 'overweight/obese subjects with mildly elevated cholesterol levels', '77 healthy adult overweight/obese subjects (aged 56\u2009±\u200910\xa0years and BMI 29.0\u2009±\u20092.7\xa0kg/m 2 ) with total cholesterol levels of 5.0-8.0\xa0mmol/L (5.9\u2009±\u20090.7\xa0mmol/L']","['OLE supplementation', '8-week olive leaf extract (OLE', 'olive leaf extract', 'placebo', 'OLE']","['liver function parameters', 'blood pressure, glucose, and insulin levels and liver function parameters', 'cardiovascular health markers', 'blood lipid profiles, oxidized low-density lipoprotein (oxLDL), blood pressure, glucose, and insulin levels', 'blood lipid levels', 'blood lipid profiles']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4517474', 'cui_str': '0.7'}]","[{'cui': 'C1364955', 'cui_str': 'Olive Leaf Extract'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",77.0,0.491868,"RESULTS


OLE supplementation did not significantly affect blood lipid levels after 4 weeks or after 8 weeks compared to placebo (all p > 0.05).","[{'ForeName': 'Yala', 'Initials': 'Y', 'LastName': 'Stevens', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology-Hepatology, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, P. O. Box 616, 6200, Maastricht, The Netherlands. yala.stevens@maastrichtuniversity.nl.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Jonkers', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology-Hepatology, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, P. O. Box 616, 6200, Maastricht, The Netherlands.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Masclee', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology-Hepatology, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, P. O. Box 616, 6200, Maastricht, The Netherlands.'}]",European journal of nutrition,['10.1007/s00394-020-02397-9']
3119,33034770,Small intracranial aneurysms in the Barrow Ruptured Aneurysm Trial (BRAT).,"BACKGROUND


Treatment of small ruptured aneurysms (SRAs) remains controversial, with literature reporting difficulty with endovascular versus microsurgical approaches. This paper analyzes outcomes after endovascular coiling and microsurgical clipping among patients with SRAs prospectively enrolled in the Barrow Ruptured Aneurysm Trial (BRAT).
METHOD


All BRAT patients were included in this study. Patient demographics, aneurysm size, aneurysm characteristics, procedure-related complications, and outcomes at discharge and at 1-year and 6-year follow-up were evaluated. A modified Rankin scale (mRS) score > 2 was considered a poor outcome.
RESULTS


Of 73 patients with SRAs, 40 were initially randomly assigned to endovascular coiling and 33 to microsurgical clipping. The rate of treatment crossover was significantly different between coiling and clipping; 25 patients who were assigned to coiling crossed over to clipping, and no clipping patients crossed over to coiling (P < 0.001). Among SRA patients, 15 underwent coiling and 58 underwent clipping; groups did not differ significantly in demographic characteristics or aneurysm type (P ≥ 0.11). Mean aneurysm diameter was significantly greater in the endovascular group (3.0 ± 0.3 vs 2.6 ± 0.6; P = 0.02). The incidence of procedure-related complications was similar for endovascular and microsurgical treatments (odds ratio [95% confidence interval], 1.0 [0.1-10.0], P = 0.98). Both groups had comparable overall outcome (mRS score > 2) at discharge and 1-year and 6-year follow-up (P = 0.48 and 0.73, respectively).
CONCLUSIONS


Most SRA patients in the BRAT underwent surgical clipping, with a high rate of crossover from endovascular approaches. Endovascular treatment was equivalent to surgical clipping with regard to procedure-related complications and neurologic outcomes.",2020,"The incidence of procedure-related complications was similar for endovascular and microsurgical treatments (odds ratio [95% confidence interval], 1.0 [0.1-10.0], P = 0.98).","['patients with SRAs prospectively enrolled in the Barrow Ruptured Aneurysm Trial (BRAT', '73 patients with SRAs']","['endovascular coiling and microsurgical clipping', 'endovascular coiling and 33 to microsurgical clipping']","['modified Rankin scale (mRS) score', 'Mean aneurysm diameter', 'incidence of procedure-related complications', 'demographic characteristics or aneurysm type']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456523', 'cui_str': 'Types of aneurysms'}]",73.0,0.171234,"The incidence of procedure-related complications was similar for endovascular and microsurgical treatments (odds ratio [95% confidence interval], 1.0 [0.1-10.0], P = 0.98).","[{'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Catapano', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Candice L', 'Initials': 'CL', 'LastName': 'Nguyen', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Frisoli', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Sagar', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Jacob F', 'Initials': 'JF', 'LastName': 'Baranoski', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Cole', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Labib', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Whiting', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Ducruet', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Felipe C', 'Initials': 'FC', 'LastName': 'Albuquerque', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA.""}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lawton', 'Affiliation': ""Department of Neurosurgery, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, 350 W. Thomas Rd., Phoenix, AZ, 85013, USA. Neuropub@barrowneuro.org.""}]",Acta neurochirurgica,['10.1007/s00701-020-04602-4']
3120,33036660,Expected impact of MRI-related interreader variability on ProScreen prostate cancer screening trial: a pre-trial validation study.,"BACKGROUND


The aim of this study is to investigate the potential impact of prostate magnetic resonance imaging (MRI) -related interreader variability on a population-based randomized prostate cancer screening trial (ProScreen).
METHODS


From January 2014 to January 2018, 100 men aged 50-63 years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI. Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers. All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N = 38) or biopsy result within 1 year from the imaging (N = 62). Fleiss' kappa (κ) was used to estimate the combined agreement between all individual radiologists. Sample data were subsequently extrapolated to 1000-men subgroups of the ProScreen cohort.
RESULTS


Altogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4 years of follow-up. Clinically significant PCa (csPCa) was identified in 76% men. For all PCa, mean sensitivity was 79% (SD ±10%, range 62-96%), and mean specificity 60% (SD ±22%, range 27-82%). For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%). Interreader agreement for any lesion was fair (κ 0.40) and for PI-RADS 4-5 lesions it was moderate (κ 0.60). Upon extrapolating these data, the average sensitivity and specificity to a screening positive subgroup of 1000 men from ProScreen with a 30% prevalence of csPCa, 639 would be biopsied. Of these, 244 men would be true positive, and 395 false positive. Moreover, 361 men would not be referred to biopsy and among these, 56 csPCas would be missed. The variation among the radiologists was broad as the least sensitive radiologist would have twice as many men biopsied and almost three times more men would undergo unnecessary biopsies. Although the most sensitive radiologist would miss only 2.6% of csPCa (false negatives), the least sensitive radiologist would miss every third.
CONCLUSIONS


Interreader agreement was fair to moderate. The role of MRI in the ongoing ProScreen trial is crucial and has a substantial impact on the screening process.",2020,"For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%).","['From January 2014 to January 2018, 100 men aged 50-63\u2009years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI', '244 men would be true positive, and 395 false positive', 'Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers', 'Altogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4\u2009years of follow-up', 'All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N\u2009=\u200938) or biopsy result within 1 year from the imaging (N\u2009=\u200962', '361 men would not be referred to biopsy and among these, 56 csPCas would be missed']",['prostate magnetic resonance imaging (MRI) -related'],"['Clinically significant PCa (csPCa', 'mean sensitivity']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",100.0,0.0652677,"For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%).","[{'ForeName': 'Ronja', 'Initials': 'R', 'LastName': 'Hietikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland. Ronja.hietikko@hus.fi.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kenttämies', 'Affiliation': 'Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ronkainen', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Ijäs', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Lind', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Marjasuo', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Oksala', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Oksanen', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Saarinen', 'Affiliation': 'Department of Radiology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ritja', 'Initials': 'R', 'LastName': 'Savolainen', 'Affiliation': 'HUS Diagnostic Center, HUS Medical Imaging Center / Radiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Mirtti', 'Affiliation': 'Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Natunen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Rannikko', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, PL900, 00029 HUS, Helsinki, Finland.'}]",Cancer imaging : the official publication of the International Cancer Imaging Society,['10.1186/s40644-020-00351-w']
3121,33036661,Efficacy of one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT) compared to nonsurgical treatment for focal articular cartilage lesions of the knee: study protocol for a crossover randomized controlled trial.,"BACKGROUND


Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). ""Instant MSC Product accompanying Autologous Chondron Transplantation"" (IMPACT) combines rapidly isolated recycled autologous chondrons with allogeneic MSCs in a one-stage surgery. IMPACT was successfully executed in a first-in-man investigator-driven phase I/II clinical trial in 35 patients. The purpose of this study is to compare the efficacy of IMPACT to nonsurgical treatment for the treatment of large (2-8 cm 2 ) articular cartilage defects in the knee.
METHODS


Sixty patients will be randomized to receive nonsurgical care or IMPACT. After 9 months of nonsurgical care, patients in the control group are allowed to receive IMPACT surgery. The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion. Cartilage formation will be assessed at baseline, and 6 and 18 months after inclusion using MRI. An independent rheumatologist will monitor the onset of a potential inflammatory response. (Severe) adverse events will be recorded. Lastly, the difference between IMPACT and nonsurgical care in terms of societal costs will be assessed by monitoring healthcare resource use and productivity losses during the study period. A health economic model will be developed to estimate the incremental cost-effectiveness ratio of IMPACT vs. nonsurgical treatment in terms of costs per quality adjusted life year over a 5-year time horizon.
DISCUSSION


This study is designed to evaluate the efficacy of IMPACT compared to nonsurgical care. Additionally, safety of IMPACT will be assessed in 30 to 60 patients. Lastly, this study will evaluate the cost-effectiveness of IMPACT compared to nonsurgical care.
TRIAL REGISTRATION


NL67161.000.18 [Registry ID: CCMO] 2018#003470#27 [EU-CTR; registered on 26 March 2019] NCT04236739 [ ClinicalTrials.gov ] [registered after start of inclusion; 22 January 2020].",2020,"The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion.","['large (2-8\u2009cm 2 ) articular cartilage defects in the knee', '26 March 2019', '30 to 60 patients', 'focal articular cartilage lesions of the knee', 'Sixty patients']","['Instant MSC Product accompanying Autologous Chondron Transplantation"" (IMPACT', 'nonsurgical care or IMPACT', 'IMPACT', 'one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT', 'IMPACT surgery']","['Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5\u2009L', 'Cartilage formation']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0007303', 'cui_str': 'Structure of articular cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0598067', 'cui_str': 'Cartilage formation'}]",35.0,0.160665,"The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion.","[{'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Korpershoek', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Vonk', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Kester', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Creemers', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'de Windt', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'M M A', 'Initials': 'MMA', 'LastName': 'Kip', 'Affiliation': 'Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Technohal, Hallenweg 5, 7522, NH, Enschede, The Netherlands.'}, {'ForeName': 'D B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'R J H', 'Initials': 'RJH', 'LastName': 'Custers', 'Affiliation': 'Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands. r.j.h.custers@umcutrecht.nl.'}]",Trials,['10.1186/s13063-020-04771-8']
3122,33036662,Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill.
TRIAL DESIGN


This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design.
PARTICIPANTS


Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days.
MAIN OUTCOMES


The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization.
RANDOMIZATION


An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization.
BLINDING (MASKING)


All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 84 participants will be randomized into two groups of 42 patients.
TRIAL STATUS


The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020.
TRIAL REGISTRATION


This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "" IRCT20200506047323N1 "". Registration date is 23 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","['patients with Severe Acute Respiratory Syndrome due to COVID-19', 'patients with confirmed COVID-19 that are moderately ill', '84 participants will be randomized into two groups of 42 patients', 'Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2', 'Age ≥18 years (weight ≥35 kg']","['Ginger', 'standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran', 'placebo', 'warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids', 'GROUP']","['recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein', 'heart disease, chronic hypertension, severe renal failure, severe liver failure', 'Moderate pneumonia and lung involvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0026457', 'cui_str': 'Monoamine oxidase inhibitor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",84.0,0.405155,"The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization.","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassaniazad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farashahinejad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04765-6']
3123,33036670,Percutaneous Coronary Intervention for Left Main Coronary Artery Bifurcation Lesions: Two-stent versus one-stent Strategy for Comparison of 6-month MACE.,"OBJECTIVE


To assess the short term clinical outcomes for a single-stent (SS) strategy versus a double-stent (DS) strategy in percutaneous coronary intervention (PCI) of distal unprotected left main coronary artery (ULMCA) lesions.
STUDY DESIGN


Descriptive comparative study.
PLACE AND DURATION OF STUDY


Armed Forces Institute of Cardiology, Rawalpindi, Pakistan from January 2017 to April 2018.
METHODOLOGY


SS treatment was defined as stenting of the main branch alone and DS treatment as stenting of both the main and side branches. Patients who underwent LMCA PCI were recruited in the study using consecutive sampling. Crossover technique, with or without kissing balloon (KB) dilatation, was employed in those getting PCI with a SS strategy; whereas, DK crush, mini-crush , culotte and T-stenting techniques were used in patients undergoing PCI with a DS strategy. The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
RESULTS


A total of 103 patients were recruited in the study; out of which, 73 underwent LMCA PCI employing a SS technique; whereas, 30 of them were treated with a DS strategy. Mean age of the study participants was 63.2 ±10.6 years.  The procedural success rate was 100% in both groups. There was a lower frequency of MACE with single-stent strategy (4.1%) versus the double-stent strategy (16.7%, p=0.031) during the 6-month follow-up period.
CONCLUSION


In comparison to the two-stent strategy of ULMCA bifurcation intervention, a single-stent approach seems to show favourable clinical outcomes and 6-month MACE-free survival. The choice of optimal revascularisation technique proves to be important for the prognosis; therefore, it requires pragmatic decision-making.   Key Words: PCI (percutaneous coronary intervention), ULMCA (unprotected left main coronary artery), SS (single-stent), DS (double-stent), MACE (major adverse cardiovascular events), CABG (cardiopulmonary bypass grafting), TLR (target lesion revascularisation).",2020,"The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
","['Mean age of the study participants was 63.2 ±10.6 years', 'patients undergoing PCI with a DS strategy', 'Patients who underwent LMCA PCI', 'percutaneous coronary intervention (PCI) of distal unprotected left main coronary artery (ULMCA) lesions', 'A total of 103 patients were recruited in the study; out of which, 73 underwent']","['LMCA PCI employing a SS technique', 'Crossover technique, with or without kissing balloon (KB) dilatation', 'PCI (percutaneous coronary intervention), ULMCA (unprotected left main coronary artery), SS (single-stent), DS (double-stent), MACE', 'single-stent (SS) strategy versus a double-stent (DS) strategy', 'Percutaneous Coronary Intervention']","['procedural success rate', 'composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C2828271', 'cui_str': 'Levomefolate calcium'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C2828271', 'cui_str': 'Levomefolate calcium'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0233926', 'cui_str': 'Kissing'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",103.0,0.0494855,"The primary endpoints were a composite of major adverse cardiovascular event (MACE) i.e. myocardial infarction, stroke or death and target lesion revascularisation (TLR).
","[{'ForeName': 'Mubarra', 'Initials': 'M', 'LastName': 'Nasir', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Hafiz Muhammad', 'Initials': 'HM', 'LastName': 'Shafique', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Tuyyab', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Armed Forces Institute of Cardiology, Rawalpindi, Pakistan.'}, {'ForeName': 'Rehana', 'Initials': 'R', 'LastName': 'Khadim', 'Affiliation': ''}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.09.894']
3124,33036674,Neurectomy versus Nerve Sparing in Open Inguinal Hernia Repair: A Randomised Controlled Trial.,"OBJECTIVE


To determine the effect of neurectomy in reducing the frequency of chronic inguinodynia after mesh hernioplasty in open inguinal hernia repair.
STUDY DESIGN


Single blind randomised controlled-trial.
PLACE AND DURATION OF STUDY


Surgical Unit-I, Department of General Surgery, Services Hospital, Lahore, Pakistan from September 2018 to September 2019.
METHODOLOGY


All male patients undergoing open groin hernia surgery were included in the study. A total of 100 patients were randomly categorised into group A (neurectomy group) and group B (nerve sparing group). Patients were followed up for three months for the development of chronic inguinodynia. Signifiance was determined at p <0.05 using Chi-square and Fisher's exact tests.
RESULTS


Out of 100 patients, 50 patients were enrolled in group A, while 50 were enrolled in group B. Mean age of patients was 42.1 ± 17.5 years. The median (IQR) acute pain score in neurectomy group was 3.0 (2.0-4.0), while median (IQR) acute pain score was 4.0 (3.0-6.0) in nerve sparing group with statistically significant difference (z = -3.256, p = 0.001). The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
CONCLUSION


Excision of ilioinguinal and iliohypogastric nerve in inguinal mesh hernioplasty reduces the frequency of chronic inguinodynia. Ilioinguinal neurectomy may be practised routinely in patients undergoing Lichtenstein mesh hernioplasty.   Key Words: Inguinal neurectomy, Inguinal hernia, Chronic inguinodynia, Lichtenstein mesh hernioplasty.",2020,"The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
","['100 patients, 50 patients were enrolled in group A, while 50 were enrolled in group', 'B. Mean age of patients was 42.1 ± 17.5 years', '100 patients', 'All male patients undergoing open groin hernia surgery', 'patients undergoing Lichtenstein mesh hernioplasty']","['Ilioinguinal neurectomy', 'Neurectomy versus Nerve Sparing in Open Inguinal Hernia Repair', 'Surgical Unit', 'randomly categorised into group A (neurectomy group) and group B (nerve sparing group', 'Inguinal neurectomy, Inguinal hernia, Chronic inguinodynia, Lichtenstein mesh hernioplasty', 'ilioinguinal and iliohypogastric nerve in inguinal mesh hernioplasty']","['median (IQR) acute pain score', 'frequency of chronic inguinodynia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}]","[{'cui': 'C0196652', 'cui_str': 'Nerve excision'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0228903', 'cui_str': 'Structure of iliohypogastric nerve'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}]",100.0,0.134133,"The frequency of chronic inguinodynia was significantly less in group A compared to group B [3 (6%) vs. 13 (26%), p = 0.012].
","[{'ForeName': 'Shabbar Hussain', 'Initials': 'SH', 'LastName': 'Changazi', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Nafeesah', 'Initials': 'N', 'LastName': 'Fatimah', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Naseer', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Wadood', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Qamar Ashfaq', 'Initials': 'QA', 'LastName': 'Ahmad', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ayyaz', 'Affiliation': 'Department of General Surgery, Services Hospital, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.09.917']
3125,33036701,"Effect of long-term omega-3 supplementation and a lifestyle multidomain intervention on intrinsic capacity among community-dwelling older adults: Secondary analysis of a randomized, placebo-controlled trial (MAPT study).","OBJECTIVES


To investigate the effect of omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice) among community-dwelling older adults on levels of intrinsic capacity (IC), a construct recently proposed by the World Health Organization.
STUDY DESIGN


Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4) randomized to one group of MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone. Data collection was held between 2008 and 2014.
MAIN OUTCOME MEASURES


IC domains were examined with the Geriatric Depression Scale (psychological); Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality). All domains were combined into a composite IC Z-score.
RESULTS


After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3: -0.16, 95 %CI: -0.22 to -0.10; MI alone: -0.13, 95 %CI: -0.19 to -0.07; ω-3 alone: -0.19, 95 %CI: -0.25 to -0.10; placebo: -0.20, 95 %CI: -0.26 to -0.14; all p < 0.0001). There were no significant differences between groups. In a sensitivity analysis with categorical time, significant within-group declines were first identified at 24 months for all groups.
CONCLUSIONS


This trial designed to improve cognitive function was unable to find effects of the intervention on the composite IC Z-score. Further investigations are needed, especially trials providing stronger interventions (such as exercise training and a controlled diet) and also embracing the sensorial domain of IC.",2020,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","['Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4', 'community-dwelling older adults']","['placebo', 'MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone', 'long-term omega-3 supplementation and a lifestyle multidomain intervention', 'omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice']","['intrinsic capacity', 'cognitive function', 'IC Z-score', 'Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality', 'Geriatric Depression Scale (psychological', 'intrinsic capacity (IC']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.119789,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","[{'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Giudici', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France. Electronic address: kellygiudici@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beard', 'Affiliation': 'University of Sydney, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Araujo de Carvalho', 'Affiliation': 'Department of Ageing and Life Course, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maturitas,['10.1016/j.maturitas.2020.06.012']
3126,33036790,Short-term weight change and live birth among women with unexplained infertility and polycystic ovary syndrome undergoing ovulation induction.,"OBJECTIVE


To determine if short-term weight change among women with unexplained infertility (UI) and polycystic ovary syndrome (PCOS) undergoing ovulation induction is associated with live birth.
DESIGN


Secondary analysis of randomized trials.
SETTING


Multicenter fertility trial sites.
PATIENT(S)


A total of 900 women with UI and 750 women with PCOS.
MAIN OUTCOME MEASURE(S)


Live birth.
INTERVENTION(S)


Weight assessment at enrollment and start of up to 4-5 cycles of clomiphene, letrozole, or gonadotropins and intrauterine insemination for women with UI and clomiphene or letrozole with regular intercourse for women with PCOS.
RESULT(S)


Weight data were available for 856 women with UI and 697 women with PCOS. Mean weight change was -0.2 ± 0.3 kg among women with UI and +2.2 ± 0.2 kg among women with PCOS and did not differ based on treatment allocation. There were 115 women with PCOS (16.4%) who gained ≥3 kg. Increased body mass index and three or more cycles were associated with weight gain in women with PCOS. There was no difference in live birth rate among women with PCOS and ≥3 kg weight gain and women with PCOS who did not gain weight.
CONCLUSION(S)


Women with PCOS gained an average of 2.2 kg regardless of the medication received, whereas women with UI experienced no short-term weight change during ovulation induction. Weight gain in women with PCOS was not associated with live birth rate.",2020,"There was no difference in live birth rate among women with PCOS and ≥3 kg weight gain and women with PCOS who did not gain weight.
","['women with unexplained infertility and polycystic ovary syndrome undergoing ovulation induction', '115 women with PCOS (16.4%) who gained ≥3 kg', '900 women with UI and 750 women with PCOS', 'women with unexplained infertility (UI) and polycystic ovary syndrome (PCOS) undergoing ovulation induction', 'Multicenter fertility trial sites', 'women with PCOS', '856 women with UI and 697 women with PCOS']","['clomiphene, letrozole, or gonadotropins and intrauterine insemination for women with UI and clomiphene or letrozole']","['weight gain', 'Weight gain', 'live birth rate', 'Mean weight change', 'Increased body mass index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517894', 'cui_str': '856'}]","[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}]",900.0,0.355194,"There was no difference in live birth rate among women with PCOS and ≥3 kg weight gain and women with PCOS who did not gain weight.
","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Vitek', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: wendy_vitek@urmc.rochester.edu.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hoeger', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Medical College of Georgia, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.002']
3127,33036845,A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial.,"BACKGROUND


Traditional pain management after total knee arthroplasty (TKA) relies heavily on opioids. Although there is evidence that in-hospital multimodal pain management (MMPM) is more effective than opioid-only (OO) analgesia, there has been little focus on postdischarge pain management. The hypothesis of this study was that MMPM after TKA would reduce pain scores and opioid consumption in the 30-day period after hospital discharge.
METHODS


This is a prospective, 2-group, comparative study with a provider cross-over design comparing a 30-day OO prn regimen with a MMPM regimen and opioid medications prn. The primary outcome measure was visual analog scale pain score and opioid-related side effects. Secondary outcome measures included morphine milligram equivalents consumed, failure of the protocol, and opioid refills.
RESULTS


There were 216 patients included in the trial, with final data available for 143. There was no clinically meaningful difference in visual analog scale score between the 2 groups at any time. Average opioid consumption at 30 days was 582.5 and 386.4 morphine milligram equivalents for the OO and MMPM cohorts, respectively (P = .0006). Average number of opioid pills consumed at 30 days was 91.8 and 60.4 for OO and MMPM cohorts, respectively (P = .0004).
CONCLUSION


A 30-day postdischarge multimodal pain regimen reduced opioid use after TKA while maintaining a similar level of pain control as the OO regimen. OO regimens are at an increased risk of needing additional medications to control pain.
LEVEL OF EVIDENCE


Level II. REGISTRY NAME: www.clinicaltrials.gov.
TRIAL NUMBER


NCT04003350.",2020,There was no clinically meaningful difference in visual analog scale score between the 2 groups at any time.,"['216 patients included in the trial, with final data available for 143', 'Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period']","['total knee arthroplasty (TKA', 'MMPM regimen and opioid medications prn']","['morphine milligram equivalents consumed, failure of the protocol, and opioid refills', 'visual analog scale score', 'pain scores and opioid consumption', 'Average opioid consumption', 'Average number of opioid pills', 'visual analog scale pain score and opioid-related side effects']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0558288', 'cui_str': 'As required'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",216.0,0.343373,There was no clinically meaningful difference in visual analog scale score between the 2 groups at any time.,"[{'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Bell', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yayac', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Barmann', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Star', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': 'Department of Orthopedics, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, PA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.060']
3128,33036887,Evaluation of Automated Delivery of Propofol Using a Closed-Loop Anesthesia Delivery System in Patients Undergoing Thoracic Surgery: A Randomized Controlled Study.,"OBJECTIVE


Automated propofol total intravenous anesthesia (TIVA) administered by a closed-loop anesthesia delivery system (CLADS) exhibits greater efficiency than conventional manual methods, but its use in major thoracic surgery is limited.
DESIGN


Prospective, single-blind, randomized controlled study.
SETTING


Single-center tertiary care hospital.
PARTICIPANTS


Patients undergoing thoracic surgery.
INTERVENTIONS


Patients were randomly allocated to receive CLADS-driven (CLADS group) or manually controlled (manual group) propofol TIVA.
MEASUREMENTS AND MAIN RESULTS


Anesthesia depth consistency (primary objective) and anesthesia delivery performance, propofol usage, work ergonomics, intraoperative hemodynamics, and recovery profile (secondary objectives) were analyzed. No differences were found for anesthesia depth consistency (percentage of time the bispectral index was within ± 10 of target) (CLADS group: 82.5% [78.5%-87.2%] v manual group: 86.5% [74.2%-92.5%]; p = 0.581) and delivery performance, including median performance error (CLADS group: 3 [-4 to 6] v manual group: 1 [-2.5 to 6]); median absolute performance error (CLADS group: 10 [10-12] v manual group:10 [8-12]); wobble (CLADS group: 10 [8-12] v manual group: 9 [6-10.5]); and global score (CLADS group: 24.2 [21.2-29.3] v manual group: 22.1 [17.3-32.3]) (p > 0.05). However, propofol requirements were significantly lower in the CLADS group for induction (CLADS group: 1.27 ± 0.21] mg/kg v manual group: 1.78 ± 0.51 mg/kg; p = 0.014) and maintenance (CLADS group: 4.02 ± 0.99 mg/kg/h v manual group: 5.11 ± 1.40 mg/kg/h; p = 0.025) of TIVA. Ergonomically, CLADS-driven TIVA was found to be significantly superior to manual control (infusion adjustment frequency/h) (manual infusion: 9.6 [7.8-14.9] v CLADS delivery [none]).
CONCLUSIONS


In thoracic surgery patients, CLADS-automated propofol TIVA confers significant ergonomic advantage along with lower propofol usage.",2020,"No differences were found for anesthesia depth consistency (percentage of time the bispectral index was within ± 10 of target) (CLADS group: 82.5% [78.5%-87.2%] v manual group: 86.5% [74.2%-92.5%]; p = 0.581) and delivery performance, including median performance error (CLADS group: 3 [-4 to 6] v manual group: 1 [-2.5 to 6]); median absolute performance error (CLADS group: 10 [10-12] v manual group:10 [8-12]); wobble (CLADS group: 10 [8-12] v manual group: 9 [6-10.5]); and global score (CLADS group: 24.2 [21.2-29.3] v manual group: 22.1 [17.3-32.3]) (p > 0.05).","['Single-center tertiary care hospital', 'Patients undergoing thoracic surgery', 'Undergoing Thoracic Surgery', 'Patients']","['propofol total intravenous anesthesia (TIVA) administered by a closed-loop anesthesia delivery system (CLADS', 'CLADS', 'CLADS-driven (CLADS group) or manually controlled (manual group) propofol TIVA', 'Propofol']","['global score', 'anesthesia depth consistency', 'delivery performance', 'median absolute performance error', 'median performance error', 'Anesthesia depth consistency (primary objective) and anesthesia delivery performance, propofol usage, work ergonomics, intraoperative hemodynamics, and recovery profile (secondary objectives']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0400342,"No differences were found for anesthesia depth consistency (percentage of time the bispectral index was within ± 10 of target) (CLADS group: 82.5% [78.5%-87.2%] v manual group: 86.5% [74.2%-92.5%]; p = 0.581) and delivery performance, including median performance error (CLADS group: 3 [-4 to 6] v manual group: 1 [-2.5 to 6]); median absolute performance error (CLADS group: 10 [10-12] v manual group:10 [8-12]); wobble (CLADS group: 10 [8-12] v manual group: 9 [6-10.5]); and global score (CLADS group: 24.2 [21.2-29.3] v manual group: 22.1 [17.3-32.3]) (p > 0.05).","[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sethi', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India. Electronic address: duttaamitabh@yahoo.co.in.'}, {'ForeName': 'Goverdhan D', 'Initials': 'GD', 'LastName': 'Puri', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Bhuwan C', 'Initials': 'BC', 'LastName': 'Panday', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sood', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Prabhat K', 'Initials': 'PK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology, Pain, and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi, India.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.09.101']
3129,33036918,A Randomized mHealth Trial to Promote Vegetable Intake Through Counting and Goal Setting.,"OBJECTIVE


To determine if counting and goal setting can increase red/orange vegetable intake.
DESIGN


Pre-posttest experimental.
SETTING


Midwestern university.
PARTICIPANTS


Undergraduate students (n = 165).
INTERVENTION


Those in the intervention group (n = 85) were asked to count the number of times they ate red/orange vegetables and set a goal to eat 1 more time.
MAIN OUTCOME MEASURE


An estimate (number of times/d) of vegetable intake based on an independent review of uploaded photographs and descriptions of meals from smartphones.
ANALYSIS


Generalized estimating equations.
RESULTS


For the intervention group, mean frequency intake increased from 0.9 times/d on Monday to 1.6 times/d on Tuesday and to 1.3 times/d on Wednesday, whereas mean intakes for the control group were 1.0, 0.8, and 0.8 times/d, respectively. There were significant group × time interactions for Tuesday (β = 0.8; P < 0.001) and Wednesday (β = 0.5; P = 0.006).
CONCLUSIONS AND IMPLICATIONS


A mobile method that helped people count their daily red/orange vegetable intake and set a goal appeared to increase consumption. This finding suggests that nutrition education programs that provide people with easy ways to track specific dietary behaviors might be effective at helping them attain goals.",2020,"There were significant group × time interactions for Tuesday (β = 0.8; P < 0.001) and Wednesday (β = 0.5; P = 0.006).
","['Midwestern university', 'Undergraduate students (n = 165']",[],['mean frequency intake'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319555', 'cui_str': '165'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",85.0,0.0448027,"There were significant group × time interactions for Tuesday (β = 0.8; P < 0.001) and Wednesday (β = 0.5; P = 0.006).
","[{'ForeName': 'Trishnee', 'Initials': 'T', 'LastName': 'Bhurosy', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Indiana University Bloomington, Bloomington, IN. Electronic address: tb664@cinj.rutgers.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Middlestadt', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Indiana University Bloomington, Bloomington, IN.'}, {'ForeName': 'Hsien-Chang', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Indiana University Bloomington, Bloomington, IN.'}, {'ForeName': 'Krisha', 'Initials': 'K', 'LastName': 'Thiagarajah', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Indiana University Bloomington, Bloomington, IN.'}, {'ForeName': 'Alyce D', 'Initials': 'AD', 'LastName': 'Fly', 'Affiliation': 'Department of Nutrition and Health Science, College of Health, Ball State University, Muncie, IN.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.08.009']
3130,33036921,A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities.,"OBJECTIVES


Despite substantial morbidity and mortality associated with acute pancreatitis (AP), only one small randomized controlled drug trial (RCT) is available in the past few decades from the United States. Hence, we conducted a single-center, double-blind, placebo-controlled RCT of pentoxifylline in AP.
METHODS


A total of 9 doses of oral pentoxifylline 400 mg or placebo tablet, three times daily, was administered within 72 h of diagnosis, using randomization blocks by pharmacy. Primary outcome was a composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis.
RESULTS


Between July 7, 2015, and April 4, 2017, we identified 685 patients with AP, 233 met eligibility criteria and 176 were approached for the study. Of these, 91 (51.7%) declined and finally 45 in pentoxifylline group and 38 in placebo group (83 total) were compared. There were no significant differences in primary outcome (27 [60.0%] vs 15 [39.5%]; P = .06). Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
CONCLUSIONS


We could not demonstrate superiority of pentoxifylline over placebo. Smaller sample size and inclusion of all types of severity might be the reasons for lack of efficacy. The challenges observed in the present study indicate that, in order to conduct a successful drug trial in AP, a multi center collaboration is essential.",2020,"Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
","['acute pancreatitis', '685 patients with AP, 233 met eligibility criteria and 176 were approached for the study']","['placebo', 'oral pentoxifylline 400\xa0mg or placebo', 'placebo-controlled RCT of pentoxifylline', 'Pentoxifylline', 'pentoxifylline']","['higher readmission rates', 'withlonger stay', 'composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0988533', 'cui_str': 'Pentoxifylline 400 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442162', 'cui_str': 'Peripancreatic'}, {'cui': 'C0267941', 'cui_str': 'Acute necrotizing pancreatitis'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]",,0.64374,"Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
","[{'ForeName': 'Santhi Swaroop', 'Initials': 'SS', 'LastName': 'Vege', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA. Electronic address: vege.santhi@mayo.edu.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Horibe', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Suresh T', 'Initials': 'ST', 'LastName': 'Chari', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Magdalen A', 'Initials': 'MA', 'LastName': 'Clemens', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Conor G', 'Initials': 'CG', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Felicity T', 'Initials': 'FT', 'LastName': 'Enders', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.09.023']
3131,33036930,Effect of trataka (yogic gazing) on insomnia severity and quality of sleep in people with insomnia.,"INTRODUCTION


Insomnia or sleeplessness is a common disorder associated with morbidity and poor quality of life. Trataka is one of the six cleansing techniques of yoga. Literature suggests that trataka could help in relieving insomnia. A study was conducted to evaluate the effect of trataka on insomnia severity and quality of sleep (QoS) in people with insomnia.
MATERIALS AND METHODS


Twenty-nine participants with insomnia were recruited, who underwent trataka (45 minutes per day daily) for a period of 10 days. Insomnia severity and QoS were assessed before and after the intervention using the Insomnia Severity Index (ISI) and The Pittsburgh Sleep Quality Index (PSQI), respectively.
RESULTS


This study showed a significant reduction in ISI score and PSQI global score and its associated subscale scores except sleep medication scores after the intervention.
CONCLUSION


Trataka may be considered as a treatment modality in reducing insomnia severity and in improving QoS in people with insomnia.",2020,"This study showed a significant reduction in ISI score and PSQI global score and its associated subscale scores except sleep medication scores after the intervention.
","['people with insomnia', 'Twenty-nine participants with insomnia were recruited, who underwent trataka (45 minutes per day daily) for a period of 10 days']",['trataka (yogic gazing'],"['Insomnia Severity Index (ISI) and The Pittsburgh Sleep Quality Index (PSQI', 'ISI score and PSQI global score', 'insomnia severity and quality of sleep (QoS', 'Insomnia severity and QoS', 'Insomnia or sleeplessness', 'insomnia severity and quality of sleep']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",29.0,0.0305485,"This study showed a significant reduction in ISI score and PSQI global score and its associated subscale scores except sleep medication scores after the intervention.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Shathirapathiy', 'Affiliation': 'Department of Naturopathy, SRK Medical College of Naturopathy and Yogic sciences, Kulasekharam, Tamil Nadu, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mooventhan', 'Affiliation': 'Department of Research and Development, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai 600106, Tamil Nadu, India. Electronic address: dr.mooventhan@gmail.com.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mangaiarkarasi', 'Affiliation': 'Department of Acupuncture and Energy Medicine, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Sangavi', 'Affiliation': 'Department of Yoga and Naturopathy, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Shanmugapriya', 'Affiliation': 'Department of Naturopathy, SRK Medical College of Naturopathy and Yogic sciences, Kulasekharam, Tamil Nadu, India; Department of Research and Development, Government Yoga and Naturopathy Medical College, Arumbakkam, Chennai 600106, Tamil Nadu, India; Department of Acupuncture and Energy Medicine, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India; Department of Yoga and Naturopathy, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India; Department of Naturopathy, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India; Department of Yoga, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Deenadayalan', 'Affiliation': 'Department of Yoga and Naturopathy, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India; Department of Naturopathy, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gayathri', 'Affiliation': 'Department of Yoga, Government Yoga and Naturopathy Medical College, Chennai, Tamil Nadu, India.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.09.009']
3132,33036946,A clinical trial of volume- versus pressure-controlled intraoperative ventilation during laparoscopic bariatric surgeries.,"BACKGROUND


Intra-operative ventilation is often challenging in patients with morbid obesity undergoing bariatric surgery.
OBJECTIVES


To test the noninferiority of pressure-controlled ventilation (PCV) to volume-controlled ventilation (VCV) in respiratory mechanics.
SETTING


Bariatric Surgery Center, Iran.
METHODS


In a randomized open-labeled clinical trial, 66 individuals with morbid obesity undergoing laparoscopic bariatric surgeries underwent intraoperative ventilation with either PCV or VCV. The measurements taken were peak and mean airway pressures (H 2 O), partial pressure of arterial oxygen (PaO 2 ), partial pressure of arterial carbon dioxide (PaCO 2 ) and end-tidal carbon dioxide (CO 2 ). We additionally collected pulse-oximetric oxygen saturation, inspiratory concentration of oxygen (FiO 2 ), and hemodynamic variables. Data were analyzed with repeated measures over the time of intubation, after peritoneal insufflation, and every 15 minutes, thereafter up to one hour.
RESULTS


PCV mode was successful to sustain adequate ventilation in 97% of the patients, which was similar to the 94% success rate of the VCV mode. Peak airway pressure increased 6 cmH 2 O and end-tidal CO 2  rose by 5 mm Hg after abdominal insufflation in both groups (P = .850 and .376). Alveolar-arterial oxygen gradient similarly increased within 30 minutes after tracheal intubation both in PCV and VCV groups, with small trend of being higher in the VCV group. The ratio of dead space to tidal volumes (VD/VT) did not have a meaningful change (P = .724).
CONCLUSION


PCV was noninferior to VCV during laparoscopic bariatric surgery. Either mode of ventilation could be alternatively used during the anesthesia care of these patients.",2020,"The ratio of dead space to tidal volumes (VD/VT) did not have a meaningful change (P = .724).
","['66 individuals with morbid obesity undergoing laparoscopic bariatric surgeries underwent', 'Bariatric Surgery Center, Iran', 'patients with morbid obesity undergoing bariatric surgery', 'laparoscopic bariatric surgeries']","['intraoperative ventilation with either PCV or VCV', 'volume- versus pressure-controlled intraoperative ventilation', 'PCV', 'pressure-controlled ventilation (PCV) to volume-controlled ventilation (VCV']","['ratio of dead space to tidal volumes (VD/VT', 'Peak airway pressure increased 6 cmH 2 O and end-tidal CO 2  rose', 'successful to sustain adequate ventilation', 'peak and mean airway pressures (H 2 O), partial pressure of arterial oxygen (PaO 2 ), partial pressure of arterial carbon dioxide (PaCO 2 ) and end-tidal carbon dioxide (CO 2 ', 'Alveolar-arterial oxygen gradient', 'pulse-oximetric oxygen saturation, inspiratory concentration of oxygen (FiO 2 ), and hemodynamic variables']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1301691', 'cui_str': 'Inspiratory concentration'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",66.0,0.0869734,"The ratio of dead space to tidal volumes (VD/VT) did not have a meaningful change (P = .724).
","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ghodraty', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Pournajafian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina Dokht', 'Initials': 'SD', 'LastName': 'Tavoosian', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khatibi', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Safari', 'Affiliation': 'Department of Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soudabeh Djalali', 'Initials': 'SD', 'LastName': 'Motlagh', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mariam Biglari', 'Initials': 'MB', 'LastName': 'Abhari', 'Affiliation': 'Department of Community Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shora', 'Initials': 'S', 'LastName': 'Shafighnia', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jahan', 'Initials': 'J', 'LastName': 'Porhomayon', 'Affiliation': 'Department of Anesthesiology, University at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Nader D', 'Initials': 'ND', 'LastName': 'Nader', 'Affiliation': 'Department of Anesthesiology, University at Buffalo, Buffalo, New York, United States. Electronic address: nnader@buffalo.edu.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.08.034']
3133,33037200,Pragmatic trial on inhaled corticosteroid withdrawal in patients with COPD in general practice.,"The therapeutic value of inhaled corticosteroids (ICSs) for COPD is limited. In published RCTs, ICS could be withdrawn in COPD patients without increasing exacerbation risk when bronchodilator treatment is optimized. Here we report on the feasibility and risks of ICS withdrawal in Dutch general practice for COPD patients without an indication for ICSs. In our pragmatic trial, general practitioners decided autonomously which of their COPD patients on ICS treatment could stop this, how this was done, and whether additional bronchodilator therapy was needed. We recruited 62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices. In 32 patients (55.2%, 95% CI: 42.5-67.3%) ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation. ICS withdrawal was successful in just over half of the patients with COPD without an indication for ICS.",2020,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","['62 COPD patients (58 analysed) who were eligible for ICS withdrawal in 79 practices', 'Dutch general practice for COPD patients without an indication for ICSs', 'patients with COPD in general practice']",['inhaled corticosteroids (ICSs'],"['ICS', 'exacerbation risk', 'severe exacerbation']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",62.0,0.152709,"ICS was withdrawn successfully, 19 (32.8%, 95% CI: 22.1-45.6%) restarted ICS treatment within six months, 12 patients (20.7%, 95% CI: 12.3-32.8%) had a moderate exacerbation, and one patient had a severe exacerbation.","[{'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van den Bemt', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands. Lisette.vandenBemt@radboudumc.nl.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van den Nieuwenhof', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rutjes', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'van der Meer', 'Affiliation': 'Budel Medical Centre, Budel, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Stege', 'Affiliation': 'Department of Pulmonology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Teichert', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00198-5']
3134,33037255,Effect of warming eyelids on tear film stability and quality of life in visual display terminal users: a randomized controlled trial.,"We aimed to evaluate the effect of warming eyelids on tear-film stability and quality of life (QoL) in video display terminal (VDT) users. A prospective study was conducted and 45 volunteers with ocular symptoms and tear-film instability associated with VDT use were randomly allocated into the study (n = 22) or control groups (n = 23). Subjects in the study group used eyelid warming steamer (EWS) for 2 weeks and tear fluorescein breakup time (TBUT) after single and 2-week EWS treatment, Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores after 2-week EWS treatment were analysed. The TBUT improved after both single and 2-week EWS treatment (P = 0.023 and 0.027, respectively) in the study group. The ocular surface staining scores were significantly decreased only in the study group (P = 0.038). About 60% DED patients in the study group shifted towards non-DED and the pattern of distribution was significantly different compared to baseline (P < 0.001). The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT. In conclusion, in VDT users with short TBUT, eyelid warming steamer is effective in improving tear-film stability and QoL.",2020,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"['visual display terminal users', '45 volunteers with ocular symptoms and tear-film instability associated with VDT use']",['warming eyelids'],"['tear-film stability and quality of life (QoL', 'ocular surface staining scores', 'non-DED', 'tear film stability and quality of life', 'QoL scores', 'Schirmer I test, ocular surface staining scores, meibomian gland assessment, severity of dry eye disease (DED) and QoL scores', 'eyelid warming steamer (EWS', 'tear-film stability and QoL', 'tear fluorescein breakup time (TBUT']","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009615', 'cui_str': 'Computer terminal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelid structure'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",45.0,0.025316,The QoL scores significantly improved in the study group (P = 0.002) with a negative correlation with TBUT.,"[{'ForeName': 'Chi-Chin', 'Initials': 'CC', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, Chang Gung Memorial Hospital, Keelung, Taiwan.'}, {'ForeName': 'Chia-Yi', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Yih-Shiou', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan.'}, {'ForeName': 'Igaki', 'Initials': 'I', 'LastName': 'Michihito', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tagami', 'Affiliation': 'Personal Health Care Products Research Laboratories, Kao Corporation, Sumida-ku, Tokyo, Japan.'}, {'ForeName': 'Ching-Hsi', 'Initials': 'CH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Medicine, School of Medicine, Chang Gung University, Taoyüan, Taiwan. hsiao.chinghsi@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-73779-6']
3135,33037261,Altered metabolomic profiling of overweight and obese adolescents after combined training is associated with reduced insulin resistance.,"Exercise training and a healthy diet are the main non-pharmacological strategies for treating chronic conditions, such as obesity and insulin resistance (IR), in adolescents. However, the isolated metabolic changes caused by exercise training without dietary intervention have not yet been established. We investigated how combined training (CT) without dietary intervention altered the concentrations of serum metabolites, biochemical, anthropometric and functional parameters in overweight and obese adolescents. Thirty-seven adolescents (14.6 ± 1.05 years), of both sexes, were randomly assigned to the control group (CG, n = 19) or the training group (TG, n = 18). The CT was composed by resistance training and aerobic training performed in the same session (~ 60 min), three times a week, for 12 weeks. All assessments were performed pre and post-intervention. Metabolomics analyses were conducted using nuclear magnetic resonance spectroscopy ( 1 H NMR) in a 600 MHz spectrometer. There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG. An increase in fat-free mass (FFM) was also observed in the CG. The metabolic changes were given mainly by changes in the levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG). These findings demonstrate the positive effects of CT program without dietary intervention on metabolomic profile, body composition, biochemical markers, and glucose metabolism in overweight and obese adolescents.",2020,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","['Thirty-seven adolescents (14.6\u2009±\u20091.05\xa0years), of both sexes', 'overweight and obese adolescents']","['CT program without dietary intervention', 'Exercise training and a healthy diet', 'exercise training without dietary intervention', 'combined training (CT) without dietary intervention']","['levels of metabolites 2-oxoisocaproate (↓TG), 3-hydroxyisobutyrate (↑CG and ↓TG), glucose (↓TG), glutamine (↓CG and ↑TG) and pyruvate (↓TG', 'concentrations of serum metabolites, biochemical, anthropometric and functional parameters', 'fat-free mass (FFM', 'body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG', 'metabolomic profile, body composition, biochemical markers, and glucose metabolism']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4068754', 'cui_str': '1.05'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0368576', 'cui_str': '2-oxoisocaproate'}, {'cui': 'C0945804', 'cui_str': '3-hydroxyisobutyrate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0139828,"There was a decrease in body weight (BW), body mass index (BMI), waist circumference (WC), % body fat (%BF), fasting glucose, insulin levels, and insulin resistance (IR), by HOMA-IR, in the TG.","[{'ForeName': 'Renata G', 'Initials': 'RG', 'LastName': 'Duft', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. renataduft@gmail.com.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ivan L P', 'Initials': 'ILP', 'LastName': 'Bonfante', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Wendell A', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, State University of Maringa, Maringa, Brazil.'}, {'ForeName': 'Larissa R', 'Initials': 'LR', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Mara P T', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education, University of Parana, Curitiba, Brazil.'}, {'ForeName': 'Cláudia R', 'Initials': 'CR', 'LastName': 'Cavaglieri', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Campinas (UNICAMP), Av. ÉricoVeríssimo, 701, Campinas, São Paulo, Brazil. cavaglieri@fef.unicamp.br.'}]",Scientific reports,['10.1038/s41598-020-73943-y']
3136,33037320,Multidimensional analyses reveal modulation of adaptive and innate immune subsets by tuberculosis vaccines.,"We characterize the breadth, function and phenotype of innate and adaptive cellular responses in a prevention of Mycobacterium tuberculosis infection trial. Responses are measured by whole blood intracellular cytokine staining at baseline and 70 days after vaccination with H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo (n = ~30 per group). H4:IC31 vaccination induces Ag85B and TB10.4-specific CD4 T cells, and an unexpected NKT like  subset, that expresses IFN-γ, TNF and/or IL-2. BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells. In vitro BCG re-stimulation also triggers responses by donor-unrestricted T cells, which may contribute to host responses against mycobacteria. BCG, which demonstrated efficacy against sustained Mycobacterium tuberculosis infection, modulates multiple immune cell subsets, in particular conventional Th1 and Th22 cells, which should be investigated in discovery studies of correlates of protection.",2020,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.",[],"['BCG', 'H4:IC31 vaccination', 'H4:IC31 (subunit vaccine containing Ag85B and TB10.4), Bacille Calmette-Guerin (BCG, a live attenuated vaccine) or placebo']","['Ag85B and TB10.4-specific CD4 T cells', 'IFNγ-producing NK cells', 'blood intracellular cytokine staining']",[],"[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]",,0.143423,"BCG revaccination increases frequencies of CD4 T cell subsets that either express Th1 cytokines or IL-22, and modestly increases IFNγ-producing NK cells.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Rozot', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. virginie.rozot@uct.ac.za.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Nemes', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Musvosvi', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Toefy', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Rantangee', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lebohang', 'Initials': 'L', 'LastName': 'Makhethe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mzwandile', 'Initials': 'M', 'LastName': 'Erasmus', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bilek', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Mabwe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Finak', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fulp', 'Affiliation': 'Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Ginsberg', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hokey', 'Affiliation': 'AERAS, Rockville, MD, USA.'}, {'ForeName': 'Muki', 'Initials': 'M', 'LastName': 'Shey', 'Affiliation': 'Aeras South Africa Endpoint Assay Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scriba', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease & Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. thomas.scriba@uct.ac.za.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Communications biology,['10.1038/s42003-020-01288-3']
3137,32538115,Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.,"INTRODUCTION


This study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access.
MATERIALS AND METHODS


This prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day's freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months.
RESULTS


There were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency ( p  = 0.029) in patients who were treated with paclitaxel-coated balloon angioplasties.
CONCLUSION


The paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.",2020,"Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group",['60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access'],"['plain balloon', 'paclitaxel-coated balloon', 'conventional plain balloon', 'stenosis or occlusion', 'Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty']","['Mean balloon diameter', '30-day procedure-related major complications or mortality', 'target lesion primary patency', 'Target lesion primary patency, circuit primary patency and secondary patency', 'safety and efficacy', 'Procedural technical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",60.0,0.0264612,"Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Karmota', 'Affiliation': 'Faculty of Medicine, Kasr Alainy - Cairo University Hospitals, Cairo, Egypt.'}]",Annals of the Royal College of Surgeons of England,['10.1308/rcsann.2020.0121']
3138,29426695,Only <10% of Patients Selected for Radical Prostatectomy Reach the Competing Mortality Rate of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,"In the Prostate Cancer Intervention Versus Observation Trial (PIVOT), surgery was not associated with lower mortality compared with observation. However, the high competing mortality rate of approximately 33% after 10 yr among the PIVOT study population has raised concerns on the generalizability of these results. We investigated 4282 patients who underwent radical prostatectomy at our institution between 1992 and 2010 to determine which subgroups harbored a competing (non-prostate cancer) mortality risk comparable to that of PIVOT and tested several combinations of higher age and comorbidities (""worst case scenarios"") to identify subgroups reaching or even superseding the competing mortality rate of the PIVOT population. The competing mortality rate of PIVOT was not reached till an age-adjusted Charlson score of 5 or higher (corresponding to an age of 70-79 yr with diabetes with end-organ damage). Only 8.9% of patients belonged to this high-risk subgroup, and only small subgroups comprising 1-5% patients superseded the competing mortality rate among the PIVOT study population. This data underline that the results of PIVOT should be used with great caution to exclude candidates for radical prostatectomy with comorbidities from curative treatment. PATIENT SUMMARY: Only <10% of patients selected for radical prostatectomy reached the competing mortality rate of approximately 33% observed in the Prostate Cancer Intervention Versus Observation Trial (PIVOT). The results of PIVOT should be used with great caution to exclude patients with concomitant diseases who seem otherwise fit for radical prostatectomy from curative treatment.",2019,The competing mortality rate of PIVOT was not reached till an age-adjusted Charlson score of 5 or higher (corresponding to an age of 70-79 yr with diabetes with end-organ damage).,"['4282 patients who underwent radical prostatectomy at our institution between 1992 and 2010 to determine which subgroups harbored a competing (non-prostate cancer) mortality risk comparable to that of PIVOT and tested several combinations of higher age and comorbidities (""worst case scenarios"") to identify subgroups reaching or even superseding the competing mortality rate of the PIVOT population']",['Prostate Cancer Intervention'],"['Mortality Rate of the Prostate Cancer Intervention', 'mortality rate', 'mortality rate of PIVOT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",4282.0,0.0182327,The competing mortality rate of PIVOT was not reached till an age-adjusted Charlson score of 5 or higher (corresponding to an age of 70-79 yr with diabetes with end-organ damage).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Froehner', 'Affiliation': 'Departments of Urology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany. Electronic address: Michael.Froehner@uniklinikum-dresden.de.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Medical Statistics and Biometry, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hübler', 'Affiliation': 'Anesthesiology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Renner', 'Affiliation': 'Departments of Urology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Borkowetz', 'Affiliation': 'Departments of Urology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zastrow', 'Affiliation': 'Departments of Urology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Manfred P', 'Initials': 'MP', 'LastName': 'Wirth', 'Affiliation': 'Departments of Urology, University Hospital ""Carl Gustav Carus"", Technische Universität Dresden, Dresden, Germany.'}]",European urology focus,['10.1016/j.euf.2018.01.019']
3139,30578392,Role of anlotinib-induced CCL2 decrease in anti-angiogenesis and response prediction for nonsmall cell lung cancer therapy.,"BACKGROUND


Anlotinib has been demonstrated in clinical trials to be effective in prolonging the progression-free survival (PFS) and overall survival (OS) of refractory advanced nonsmall cell lung cancer (NSCLC) patients. However, the underlying molecular mechanisms and predictive biomarkers of anlotinib are still unclear.
METHODS


A retrospective analysis of anlotinib administered to 294 NSCLC patients was performed to screen for underlying biomarkers of anlotinib-responsive patients. Transcriptome and functional assays were performed to understand the antitumour molecular mechanisms of anlotinib. Changes in serum CCL2 levels were analysed to examine the correlation of the anlotinib response between responders and nonresponders.
RESULTS


Anlotinib therapy was beneficial for prolonging OS in NSCLC patients harbouring positive driver gene mutations, especially patients harbouring the epithelial growth factor receptor (EGFR) T790M  mutation. Moreover, anlotinib inhibited angiogenesis in an NCI-H1975-derived xenograft model  via  inhibiting CCL2. Finally, anlotinib-induced serum CCL2 level decreases were associated with the benefits of PFS and OS in refractory advanced NSCLC patients.
CONCLUSIONS


Our study reports a novel anti-angiogenesis mechanism of anlotinib  via  inhibiting CCL2 in an NCI-H1975-derived xenograft model and suggests that changes in serum CCL2 levels may be used to monitor and predict clinical outcomes in anlotinib-administered refractory advanced NSCLC patients using third-line therapy or beyond.",2019,"Changes in serum CCL2 levels were analysed to examine the correlation of the anlotinib response between responders and nonresponders.
","['294 NSCLC patients', 'refractory advanced nonsmall cell lung cancer (NSCLC) patients', 'nonsmall cell lung cancer therapy', 'refractory advanced NSCLC patients']",['anlotinib-induced CCL2'],"['serum CCL2 levels', 'progression-free survival (PFS) and overall survival (OS', 'epithelial growth factor receptor (EGFR', 'serum CCL2 level']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0206454', 'cui_str': 'Growth Factor Receptors'}]",294.0,0.0734703,"Changes in serum CCL2 levels were analysed to examine the correlation of the anlotinib response between responders and nonresponders.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Tianqing', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Runbo', 'Initials': 'R', 'LastName': 'Zhong', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Central laboratory, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mohammad Shah', 'Initials': 'MS', 'LastName': 'Alam', 'Affiliation': 'Bio-ID Center, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'School of Life Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Bio-ID Center, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Dept of Thoracic Oncology, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Central laboratory, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Dept of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}]",The European respiratory journal,['10.1183/13993003.01562-2018']
3140,30680828,Rationale and budget impact of bimonthly use of Cetuximab in patients with recurrent and/or metastatic head and neck cancer.,"BACKGROUND


In recurrent and/or metastatic head and neck squamous cell cancer, Cetuximab is administered once a week, followed by weekly doses. We present the clinical rationale of a different schedule of maintenance Cetuximab and we estimate the potential economic benefits on the health care budget from a societal perspective in Italy.
METHODS


A budget impact (BI) excel-based model was developed comparing a base case scenario of 100% weekly administration with a dose of 250 mg/m 2  to an every-other-week (EOW) administration at 50% or 100% with a dose of 500 mg/m 2  .
RESULTS


In the EOW, 50% scenario it was calculated a cost reduction of €347 000 of which 70% attributable to indirect costs, increasing to €694 000 after 4 months.
CONCLUSIONS


In our analysis, we showed that this simplified schedule could also reduce the costs of treatments both for the health system (direct costs) and for the society (indirect costs).",2019,"In our analysis, we showed that this simplified schedule could also reduce the costs of treatments both for the health system (direct costs) and for the society (indirect costs).","['recurrent and/or metastatic head and neck squamous cell cancer', 'patients with recurrent and/or metastatic head and neck cancer']",['Cetuximab'],[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744619', 'cui_str': 'Head and neck cancer metastatic'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}]",[],,0.0348058,"In our analysis, we showed that this simplified schedule could also reduce the costs of treatments both for the health system (direct costs) and for the society (indirect costs).","[{'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Mennini', 'Affiliation': 'Economic Evaluation and HTA (CEIS-EEHTA) - Faculty of Economics, University of Rome ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marcellusi', 'Affiliation': 'Economic Evaluation and HTA (CEIS-EEHTA) - Faculty of Economics, University of Rome ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fabiano', 'Affiliation': 'Economic Evaluation and HTA (CEIS-EEHTA) - Faculty of Economics, University of Rome ""Tor Vergata"", Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Platini', 'Affiliation': 'Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, Italy.'}]",Head & neck,['10.1002/hed.25481']
3141,31106415,"Short- and longer-term impacts of Child Friendly Space Interventions in Rwamwanja Refugee Settlement, Uganda.","BACKGROUND


The establishment of Child Friendly Spaces (CFSs) has become a widespread intervention targeting protection and support for displaced children in humanitarian contexts. There is a lack of evidence of impact of these interventions with respect to both short-term outcomes and longer-term developmental trajectories.
METHODS


We collected data from caregivers of Congolese refugee children residing in Rwamwanja Refugee Settlement at three timepoints. To assess short-term impact of CFSs, we compared indicators assessed shortly after refugees' arrival (baseline, T1) and endline (T2, three to six months after CFS implementation) amongst 430 CFS attenders and 161 nonattenders. Follow-up assessments after the end of CFS programming were conducted 18 months post-baseline (T3) with caregivers of 249 previous CFS attenders and 77 CFS nonattenders.
RESULTS


In the short-term, attendance at CFSs was associated with better maintenance of psychosocial well-being (PSWB; β = 2.093, p < .001, Cohen's d = .347) and greater increases in developmental assets (β = 2.517, p < .001, Cohen's d = .231), with significantly stronger impacts for girls. CFS interventions meeting higher programing quality criteria were associated with greater impact on both PSWB and development assets (β = 2.603 vs. β = 1.793 and β = 2.942 vs. β = 2.337 for attenders at higher and lower-quality CFSs c.f. nonattenders, respectively). Amongst boys, benefits of program attendance were only indicated for those attending higher-quality CFS (β = 2.084, p = .006 for PSWB). At follow-up, however, there were no discernable impacts of prior CFS attendance on any measures. Age and school attendance were the only characteristics that predicted an outcome - developmental assets - at follow-up.
CONCLUSIONS


Attendance at CFSs - particularly involving higher-quality programming - supported children's well-being and development. However, sustained impact beyond active CFS programming was not demonstrated. Intervention goals and strategies in humanitarian contexts need to address the challenge of connecting children to other resources to facilitate developmental progress in conditions of protracted displacement.",2019,"In the short-term, attendance at CFSs was associated with better maintenance of psychosocial well-being (PSWB; β = 2.093, p < .001, Cohen's d = .347) and greater increases in developmental assets (β = 2.517, p < .001, Cohen's d = .231), with significantly stronger impacts for girls.","['Rwamwanja Refugee Settlement, Uganda', 'We collected data from caregivers of Congolese refugee children residing in Rwamwanja Refugee Settlement at three timepoints', '430 CFS attenders and 161 nonattenders']",['Child Friendly Space Interventions'],['Age and school attendance'],"[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0749066,"In the short-term, attendance at CFSs was associated with better maintenance of psychosocial well-being (PSWB; β = 2.093, p < .001, Cohen's d = .347) and greater increases in developmental assets (β = 2.517, p < .001, Cohen's d = .231), with significantly stronger impacts for girls.","[{'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Metzler', 'Affiliation': 'Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Diaconu', 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University, Edinburgh, Scotland, UK.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Hermosilla', 'Affiliation': 'New York State Psychiatric Institute, Columbia University, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaijuka', 'Affiliation': 'World Vision Uganda, Kampala, Uganda.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ebulu', 'Affiliation': 'World Vision Uganda, Kampala, Uganda.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Savage', 'Affiliation': 'Humanitarian and Emergency Affairs, World Vision International, Geneva, Switzerland.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Ager', 'Affiliation': 'Department of Population and Family Health, Mailman School of Public Health, Columbia University, New York, NY, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13069']
3142,31764094,Delayed gastrointestinal-associated lymphoid tissue reconstitution in duodenum compared with rectum in HIV-infected patients initiating antiretroviral therapy.,"BACKGROUND


We aimed to characterize the impact of antiretroviral therapy (ART) initiation on gastrointestinal-associated lymphoid tissue at various sites along the gastrointestinal site.
METHODOLOGY


Peripheral blood and duodenal and rectal biopsies were obtained from 12 HIV to 33 treatment-naive HIV participants at baseline and after 9 months ART. Tissue was digested for immunophenotyping. Inflammatory, bacterial translocation and intestinal damage markers were measured in plasma.
RESULTS


Twenty-six HIV patients completed follow-up. The lowest reconstitution of CD4 T cells and the lowest CD4/CD8 ratio during ART compared with blood were observed in the duodenum with the rectum being either intermediate or approaching blood levels. Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART. Several correlations with biomarkers of microbial translocation were observed including increases in lipoteichoic acid levels, which reflects Gram-positive bacterial translocation, correlated with increases in %CD4 T cells in the duodenum (Rho 0.773, P = 0.033), and with decreases in duodenal regulatory T-cell populations (Rho -0.40, P = 0.045).
CONCLUSION


HIV-mediated immunological disruption is greater in the duodenum than rectum and blood before and during ART. Small intestine damage may represent a unique environment for T-cell depletion, which might be attenuated by interaction with Gram-positive bacteria.",2019,Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART.,"['Peripheral blood and duodenal and rectal biopsies were obtained from 12 HIV to 33 treatment-naive HIV participants at baseline and after 9 months ART', 'Twenty-six HIV patients completed follow-up']",['antiretroviral therapy (ART) initiation'],"['Delayed gastrointestinal-associated lymphoid tissue reconstitution', 'CD4 T cells', 'lowest reconstitution of CD4 T cells and the lowest CD4/CD8 ratio', 'Regulatory T cells', 'duodenal regulatory T-cell populations', 'lipoteichoic acid levels', 'Inflammatory, bacterial translocation and intestinal damage markers']","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0193050', 'cui_str': 'Biopsy of rectum'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024296', 'cui_str': 'Lymphatic tissue'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0065067', 'cui_str': 'lipoteichoic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282583', 'cui_str': 'Bacterial translocation'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",26.0,0.0917926,Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART.,"[{'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Sainz', 'Affiliation': 'Department of Pediatrics, La Paz University Hospital and Research Institute (ldiPAZ), Madrid.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Serrano-Villar', 'Affiliation': 'Department of Infectious Diseases, Ramon y Cajal University Hospital and Research Institute (IRYCIS), Faculty of Medicine, University of Alcalá, Alcalá, Spain.'}, {'ForeName': 'Surinder', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}, {'ForeName': 'Zhong-Min', 'Initials': 'ZM', 'LastName': 'Ma', 'Affiliation': 'California National Primate Research Center, Davis, California.'}, {'ForeName': 'Netanya S', 'Initials': 'NS', 'LastName': 'Utay', 'Affiliation': 'University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Corbin G', 'Initials': 'CG', 'LastName': 'Thompson', 'Affiliation': 'School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Kashuba', 'Affiliation': 'School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Basile', 'Initials': 'B', 'LastName': 'Siewe', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Albanese', 'Affiliation': 'Veterans Administration Northern California Health Care System, Mather.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Troia-Cancio', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sinclair', 'Affiliation': 'University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Anoma', 'Initials': 'A', 'LastName': 'Somasunderam', 'Affiliation': 'University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Yotter', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Pediatrics, La Paz University Hospital and Research Institute (ldiPAZ), Madrid.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Pollard', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Asmuth', 'Affiliation': 'University of California Davis Medical Center, Sacramento.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002361']
3143,32070210,Effectiveness of a pharmaceutical instruction video for adherence to dermatopathy treatment in patients with cancer receiving the anti-epidermal growth factor receptor antibody.,"BACKGROUND


Dermatopathy develops as a side effect in patients receiving anti-epidermal growth factor receptor antibody treatment. Topical moisturizers are used for the prevention and treatment of this dermatopathy. Active participation of patients in their own treatment is important for the appropriate application of topical preparations. We prepared a pharmaceutical instructional video for adhering to the topical application protocol. In this study, we investigated the effectiveness of this pharmaceutical instructional video on treatment adherence.
METHODS


Study participants were patients with cancer receiving the anti-epidermal growth factor receptor antibody for the first time. A pharmacist instructed the patients on how to use the pharmaceutical instruction video. Daily topical preparation use following the video demonstration was assessed. The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2). The incidence of side effects was compared between the two control groups and the group of patients who received the pharmaceutical instruction video.
RESULTS


The amount of topical preparation consumed (median, g/day) by patients who received patient compliance instructions using the pharmaceutical instruction video was 9.8 g/day, as compared with control group 1 (4.5 g/day) and control group 2 (5.5 g/day) ( p  <   0.001). There was no difference in the incidence of side effects during the three periods.
CONCLUSION


The use of visual instructional media for patient compliance by pharmacists may be effective in maintaining and improving treatment adherence.",2020,The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2).,"['Study participants were patients with cancer receiving the anti-epidermal growth factor receptor antibody for the first time', 'patients receiving anti-epidermal growth factor receptor antibody treatment', 'patients who did not use the pharmaceutical instruction video for the past 2 periods (26\u2009months; controls 1 and 2', 'patients with cancer receiving the anti-epidermal growth factor receptor antibody']","['visual instructional media', 'pharmaceutical instructional video', 'pharmaceutical instruction video']",['incidence of side effects'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0273452,The effectiveness of the pharmaceutical instruction video was evaluated by assessing the adherence of patients who did not use the pharmaceutical instruction video for the past 2 periods (26 months; controls 1 and 2).,"[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yasuda', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kiyohara', 'Affiliation': 'Department of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamawaki', 'Affiliation': 'Department of Drug Discovery Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Oshika Pharmacy KRAFT, Inc., Tochigi, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Shino', 'Affiliation': 'Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155220904149']
3144,32421350,Sex differences in endothelial function in chronic kidney disease.,"Vascular dysfunction plays an important role in the etiology of chronic kidney disease (CKD) and is associated with cardiovascular diseases. Sex differences in vascular function are common in clinical and nonclinical populations. However, no data exist in individuals with CKD. The present study tested the hypothesis that sex and/or aging differences exist in vascular function in patients with CKD. Endothelium-dependent dilation (EDD; measured via brachial artery flow-mediated dilation) and endothelium-independent dilation (EID; measured via nitroglycerin-mediated dilation) were assessed. Analyses were adjusted for several variables that could influence vascular function (diabetes, cardiovascular disease, and blood pressure). Women, in general, had higher EDD values than men (6.5 ± 4.9% vs. 4.4 ± 3.4%); however, EID did not differ among these groups. In younger men and women (<55 yr old), EDD and EID were higher ( P  < 0.05) than their older (≥55 yr old) counterparts (EDD: 7.0 ± 4.1% vs. 4.4 ± 3.8% and EID: 24.0 ± 9.6% vs. 18.3 ± 9.2%). Additionally, younger women exhibited higher ( P  < 0.05) EDD and EID compared with younger men (EDD: 9.5 ± 6.4% vs. 5.1 ± 3.8%,  P  = 0.01, and EID: 24.0 ± 9.6% vs. 18.3 ± 9.2%). No differences in EDD and EID were present between older men and women with CKD. Diabetes independently predicted lower EID but not EDD in men and women. Blood pressure and cardiovascular disease did not predict EDD or EID. This is the first study to show significant sex differences in vascular function. Moreover, these differences are evident between younger men and women with CKD but are abolished with age. Additional studies are needed to better understand the mechanisms that may underlie sex differences in vascular dysfunction with CKD.",2020,"In younger men and women (<55 yr old), EDD and EID were higher ( P  < 0.05) than their older (≥55 yr old) counterparts (EDD: 7.0 ± 4.1% vs. 4.4 ± 3.8% and EID: 24.0 ± 9.6% vs. 18.3 ± 9.2%).","['younger men and women with CKD', 'older men and women with CKD', 'chronic kidney disease', 'patients with CKD', 'individuals with CKD', 'younger men and women (<55 yr old), EDD and EID were higher ( P  < 0.05) than their older (≥55 yr old) counterparts (EDD: 7.0\u2009±\u20094.1% vs. 4.4\u2009±\u20093.8% and EID: 24.0\u2009±\u20099.6% vs. 18.3\u2009±\u20099.2']",[],"['vascular function (diabetes, cardiovascular disease, and blood pressure', 'Blood pressure and cardiovascular disease', 'Endothelium-dependent dilation (EDD; measured via brachial artery flow-mediated dilation) and endothelium-independent dilation (EID; measured via nitroglycerin-mediated dilation', 'EDD and EID']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C5191219', 'cui_str': '9.2'}]",[],"[{'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",,0.0593494,"In younger men and women (<55 yr old), EDD and EID were higher ( P  < 0.05) than their older (≥55 yr old) counterparts (EDD: 7.0 ± 4.1% vs. 4.4 ± 3.8% and EID: 24.0 ± 9.6% vs. 18.3 ± 9.2%).","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Kruse', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Carver College of Medicine, Iowa City, Iowar.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Moreau', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jalal', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Carver College of Medicine, Iowa City, Iowar.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00156.2020']
3145,33037518,"Efficacy of Getong Tongluo Capsule () for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial.","OBJECTIVE


To evaluate whether the efficacy of Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension.
METHODS


This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed.
RESULTS


The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05).
CONCLUSION


GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).",2020,"There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05).
","['Totally 477 eligible patients from 18 hospitals in China', 'September 2015 to October 2017', 'Ischemic Stroke and Primary Hypertension', 'patients with convalescent-phase ischemic stroke and primary hypertension']","['GTC', 'GTC-matching placebo 250 mg plus EGB-matching placebo', 'EGB 40 mg plus GTC-matching placebo', 'Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae', 'aspirin enteric-coated tablets', 'Getong Tongluo Capsule ', 'placebo', 'GTC 250 mg plus EGB-matching placebo', 'Ginkgo biloba (EGB']","['total effective rates of NIHSS', 'Barthel Index (BI', 'control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores', 'incidences of AEs, adverse drug reactions, or serious AEs', 'incidence and severity of adverse events (AEs', ""patients' quality of life"", 'control rate of blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0439558', 'cui_str': 'Convalescent phase'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330206', 'cui_str': 'Ginkgo biloba'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2352019', 'cui_str': 'tongluo'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016219', 'cui_str': '2-Phenyl-2-Ene-Benzopyran-4-One Compounds'}, {'cui': 'C0242726', 'cui_str': 'Plant roots'}, {'cui': 'C0950068', 'cui_str': 'Puerariae'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",477.0,0.609794,"There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05).
","[{'ForeName': 'Qian-Yu', 'Initials': 'QY', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.'}, {'ForeName': 'Rong-Hua', 'Initials': 'RH', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Guo-Xiong', 'Initials': 'GX', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, the Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine, Nanchang, 330006, China.'}, {'ForeName': 'Xu-Zheng', 'Initials': 'XZ', 'LastName': 'Cao', 'Affiliation': ""Department of Neurology, the 211th Hospital of the People's Liberation Army, Harbin, 150000, China.""}, {'ForeName': 'Lu-Ran', 'Initials': 'LR', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, the Fourth Hospital Affiliated to Harbin Medical University, Harbin, 150000, China.'}, {'ForeName': 'Ji-Hua', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, the First Hospital of Suihua, Suihua, Heilongjiang Province, 152053, China.'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, the 88th Hospital of the People's Liberation Army, Tai'an, Shandong Province, 271000, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Xinhua Hospital of Zhejiang Province, Hangzhou, 310005, China.'}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, the Second Provincial People's Hospital of Gansu, Lanzhou, 730000, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, People's Hospital of Bozhou, Bozhou, Anhui Province, 236800, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Neurosurgery, the Third Hospital Affiliated to Shanxi University of Chinese Medicine, Taiyuan, 030000, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, the First People's Hospital of Huainan, Huainan, Anhui Province, 232007, China.""}, {'ForeName': 'Wen-Zong', 'Initials': 'WZ', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Wenzhou Hospital of Traditional Chinese Medicine, Wenzhou, Zhejiang Province, 325000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, the First Hospital Affiliated to Medical College of Shihezi University, Shihezi, Xinjiang Uygur Autonomous Region, 832008, China.'}, {'ForeName': 'Hong-Lin', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, the Second Hospital Affiliated to Heilongjiang University of Traditional Chinese Medicine, Harbin, 150001, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Ma', 'Affiliation': ""Department of Neurology, People's Hospital of Xinzhou, Xinzhou, Shanxi Province, 034000, China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': ""Department of Neurology, People's Hospital of Weifang, Weifang, Shandong Province, 261000, China.""}, {'ForeName': 'Yan-Jie', 'Initials': 'YJ', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.'}, {'ForeName': 'Yun-Hai', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xiangya Hospital Affiliated to Central South University, Changsha, 410013, China.'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. chenzhigang64@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3320-3']
3146,33037606,A Comparative Study on the Clinical Efficacy of Modified Circumcision and Two Other Types of Circumcision.,"PURPOSE


To compare the clinical effects of three methods of circumcision: modified circumcision, traditional circumcision, and disposable suturing device circumcision.
MATERIALS AND METHODS


Male patients (n = 241) with redundant prepuce and/or phimosis were included in a clinical trial from January 2019 to March 2020. Patients were divided into 3 groups based on the surgical method: group A, traditional circumcision (n = 79); group B, modified circumcision (n = 80); and group C, disposable suturing device circumcision (n = 82).
RESULTS


The operation times in groups A, B, and C were 25.2 ± 3.3 min, 10.2 ± 2.7 min, and 6.7 ± 1.4 min, respectively. The volumes of intraoperative blood loss in groups A, B, and C were 12.7 ± 2.3 mL, 8.1 ± 3.4 mL, and 2.2 ± 0.8 mL, respectively (P < 0.05). Groups A and B were superior to group C in terms of the 6-h postoperative visual analog scale score and appearance satisfaction (P < 0.05). There were no obvious differences in the 7-day postoperative pain score and total healing time (P > 0.05). The operating expenses in groups A and B were lower than that in group C (P < 0.05).
CONCLUSION


Modified circumcision, with its advantages of shorter operation time, less blood loss and pain, lower cost, and better postoperative penile appearance, is easily accepted by patients and deserves wide clinical application.",2020,Groups A and B were superior to group C in terms of the 6-h postoperative visual analog scale score and appearance satisfaction (P < 0.05).,"['and/or phimosis were included in a clinical trial from January 2019 to March 2020', 'Male patients (n = 241) with redundant prepuce']","['modified circumcision', 'traditional circumcision', 'circumcision: modified circumcision, traditional circumcision, and disposable suturing device circumcision', 'Modified Circumcision and Two Other Types of Circumcision', 'disposable suturing device circumcision']","['postoperative visual analog scale score and appearance satisfaction', 'volumes of intraoperative blood loss', '7-day postoperative pain score and total healing time', 'blood loss and pain, lower cost, and better postoperative penile appearance', 'operating expenses']","[{'cui': 'C0031538', 'cui_str': 'Phimosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0345325', 'cui_str': 'Redundant prepuce'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}]",241.0,0.0163504,Groups A and B were superior to group C in terms of the 6-h postoperative visual analog scale score and appearance satisfaction (P < 0.05).,"[{'ForeName': 'Quanxin', 'Initials': 'Q', 'LastName': 'Su', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. su18340860412@163.com.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. gsl11111111@163.com.""}, {'ForeName': 'Jiasheng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. chenjiasheng7686555@126.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chao', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. deerchao@163.com.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Weijiang', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. 549896845@qq.com.""}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xingyu', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. czeyww@126.com.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. nj-likky@163.com.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Urology, The Afliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou 213003, Jiangsu, China. 1600514835@qq.com.""}]",Urology journal,['10.22037/uj.v16i7.6193']
3147,33037632,Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study.,"BACKGROUND/OBJECTIVES


In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.
DESIGN


Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.
SETTING


A total of 86 primary care practices within 10 U.S. healthcare systems.
PARTICIPANTS


A random subsample of 743 persons aged 75 and older.
MEASUREMENTS


The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.
RESULTS


Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.
CONCLUSIONS


STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.",2020,"CONCLUSIONS


STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.","['A total of 86 primary care practices within 10 U.S. healthcare systems', 'Elders', 'Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age', 'A random subsample of 743 persons aged 75 and older', '5,451 community-living persons at high risk for serious fall injuries']",['Multifactorial Fall Injury Prevention Intervention'],"['modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument', 'fall injuries', 'Mean scores', 'anxiety and depression']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0133732', 'cui_str': 'OF 743'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0085639', 'cui_str': 'Falls'}]","[{'cui': 'C0085639', 'cui_str': 'Falls'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0085639', 'cui_str': 'Falls'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5451.0,0.0304575,"CONCLUSIONS


STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale Claude D. Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Boult', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Albert W', 'Initials': 'AW', 'LastName': 'Wu', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': 'Meyers Primary Care Institute, A Joint Endeavor of Reliant Medical Group, Fallon Health and University of Massachusetts Medical School, Worcester, Massachusetts, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rich', 'Affiliation': 'HealthCare Partners, El Segundo, California, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'University of Texas Medical Branch Claude D. Pepper Older Americans Independence Center; Sealy Center on Aging, The University of Texas Medical Branch, Galveston, Texas, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Waring', 'Affiliation': 'Essentia Health, Duluth, Minnesota, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Lillian C', 'Initials': 'LC', 'LastName': 'Min', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, RiverSpring Health, Bronx, New York, USA.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'McMahon', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': 'Yale Claude D. Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': 'Yale Claude D. Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Gazarian', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Allore', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanson', 'Affiliation': 'University of Miami Health System, Miami, Florida, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Ko', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Resnick', 'Affiliation': 'Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Wiggins', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Goehring', 'Affiliation': ""Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Fagan', 'Affiliation': 'University of Miami Health System, Miami, Florida, USA.'}, {'ForeName': 'Rosaly', 'Initials': 'R', 'LastName': 'Correa-de-Araujo', 'Affiliation': 'National Institute on Aging, Bethesda, Maryland, USA.'}, {'ForeName': 'Carri', 'Initials': 'C', 'LastName': 'Casteel', 'Affiliation': 'University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16854']
3148,33037644,Educating junior doctors and pharmacists to reduce discharge prescribing of opioids for surgical patients: a cluster randomised controlled trial.,"OBJECTIVES


To evaluate whether educating junior doctors and hospital pharmacists about analgesic prescribing improved discharge prescribing of opioids for opioid-naïve patients after surgical admissions.
DESIGN


Cluster randomised controlled trial, undertaken during the first half of 2019.
SETTING


The Alfred Hospital, a major Melbourne teaching hospital with 13 surgical units.
PARTICIPANTS


Opioid-naïve patients discharged from surgical units after a stay of at least 24 hours.
INTERVENTION


Surgical units were randomised to the intervention or control arms. Interns, residents, and clinical pharmacists assigned to intervention arm units attended education sessions, presented by the hospital analgesic stewardship pharmacist, about appropriate analgesic prescribing for patients in hospital surgical units.
MAIN OUTCOME MEASURES


The patients prescribed slow release opioids on discharge from hospital during the baseline (1 February - 30 April 2018) and post-intervention periods (17 February - 30 April 2019).
RESULTS


During the baseline period, 1369 intervention unit and 1014 control unit admissions were included in our analysis; during the evaluation period, 973 intervention unit and 706 control unit episodes were included. After adjusting for age, length of stay, pain score, acute pain service involvement, and use of immediate release opioids prior to admission, patients in the intervention group were prescribed slow release opioids at discharge less frequently than patients in the control group (adjusted odds ratio [aOR], 0.52; 95% CI, 0.35-0.77) and were more frequently discharged without any prescribed opioids following the intervention (aOR, 1.69; 95% CI, 1.24-2.30). Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
CONCLUSIONS


Specific education for clinicians and pharmacists about appropriate analgesic prescribing for surgical patients is effective in reducing prescribing of opioids at discharge.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12618000876291 (prospective).",2020,"Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
","['educating junior doctors and hospital pharmacists about analgesic prescribing improved discharge prescribing of opioids for opioid-naïve patients after surgical admissions', 'Opioid-naïve patients discharged from surgical units after a stay of at least 24 hours', 'patients prescribed slow release opioids on discharge from hospital during the baseline (1 February - 30 April 2018) and post-intervention periods (17 February - 30 April 2019', 'surgical patients', '1369 intervention unit and 1014 control unit admissions were included in our analysis; during the evaluation period, 973 intervention unit and 706 control unit episodes were included', 'The Alfred Hospital, a major Melbourne teaching hospital with 13 surgical units']",[],"['length of stay, pain score, acute pain service involvement', 'slow release opioids']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0402002', 'cui_str': 'Hospital pharmacist'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]",[],"[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0242934', 'cui_str': 'Acute pain service'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.113927,"Providing de-escalation plans was more frequent for intervention than control group patients prescribed slow release opioids on discharge post-intervention (OR, 2.36; 95% CI, 1.25-4.45).
","[{'ForeName': 'Ria E', 'Initials': 'RE', 'LastName': 'Hopkins', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Bui', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Konstantatos', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}, {'ForeName': 'Dianna J', 'Initials': 'DJ', 'LastName': 'Magliano', 'Affiliation': 'Baker IDI Heart and Diabetes Institute, Melbourne, VIC.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dooley', 'Affiliation': 'Alfred Health, Melbourne, VIC.'}]",The Medical journal of Australia,['10.5694/mja2.50812']
3149,33037656,Effect of recombinant human growth hormone on liver fat content in young adults with nonalcoholic fatty liver disease.,"BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) is highly prevalent in young adults with obesity. Obesity is associated with relative growth hormone (GH) deficiency, and data from animal studies and from humans with pituitary GH deficiency suggest a role for GH deficiency in the pathogenesis of NAFLD. The effects of GH on NAFLD in those with obesity are unknown, however, prompting this pilot study to assess effects of GH administration on measures of NAFLD in young adults.
METHODS


Twenty-four men and women aged 18-29 years with BMI ≥ 30 kg/m 2  , hepatic fat fraction (HFF) ≥ 5% on proton magnetic resonance spectroscopy ( 1  H-MRS) and insulin-like growth factor 1 (IGF-1) z-score ≤ 0 were randomized to treatment with recombinant human GH (rhGH) versus no treatment for 24 weeks. The primary endpoint was change in HFF.
RESULTS


Compared to no treatment, the effect size of rhGH on absolute HFF over 24 weeks was -3.3% (95% confidence interval: -7.8%, 1.2%; p = .14). At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04). rhGH did not significantly reduce ALT, AST or GGT. Serum IGF-1 increased as expected with rhGH treatment, and there were no changes in fasting lipids, C-reactive protein, fasting glucose or 2-h glucose following an oral glucose tolerance test.
CONCLUSION


Data from this pilot study suggest that rhGH treatment in young adults with obesity and NAFLD may have benefits to reduce liver fat content, although larger studies are needed to confirm this effect.",2020,"At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04).","['Twenty-four men and women aged 18-29\xa0years with BMI\xa0≥\xa030\xa0kg/m 2  , hepatic fat fraction (HFF', 'young adults with obesity', 'young adults', 'young adults with obesity and NAFLD', 'young adults with nonalcoholic fatty liver disease']","['recombinant human GH (rhGH', 'GH', 'recombinant human growth hormone', 'proton magnetic resonance spectroscopy ( 1  H-MRS) and insulin-like growth factor 1', 'rhGH']","['change in HFF', 'effect size of rhGH on absolute HFF', 'fasting lipids, C-reactive protein, fasting glucose or 2-h glucose following an oral glucose tolerance test', 'liver fat content', 'Serum IGF-1', 'ALT, AST or GGT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",24.0,0.0711934,"At 24 weeks, HFF < 5% was achieved in 5 of 9 individuals receiving rhGH versus 1 of 9 individuals receiving no treatment (p = .04).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julian J', 'Initials': 'JJ', 'LastName': 'Weiss', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Branch', 'Affiliation': 'Translational and Clinical Research Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Pediatric Endocrine Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Clinical endocrinology,['10.1111/cen.14344']
3150,33037681,Intracellular vincristine levels in lymphoblasts affect treatment outcome in childhood B-lymphoblastic leukaemia: Ma-Spore ALL 2010 Study.,"AIMS


Vincristine (VCR) is a key drug in the successful multi-drug chemotherapy for childhood ALL. But it remains unclear how VCR pharmacokinetics affects its anti-leukaemic efficacy. The objective of this study is to explore the VCR PK parameters and intracellular VCR levels in an up-front window of Ma-Spore ALL 2010 (MS2010) study.
METHODS


We randomised 429 children with newly diagnosed ALL to 15 min versus 3-h infusion for the first dose of VCR to study if prolonging the first dose of VCR infusion improved response. In a subgroup of 115 B-ALL and 20 T-ALL patients, we performed VCR plasma (n=135 patients) and intracellular (n=66 patients) pharmacokinetic studies. The correlations between PK parameters and intracellular VCR levels with early treatment response, final outcome and ABCB1 genotypes were analysed.
RESULTS


Between 15 min versus 3-h infusion schedules, there was no significant difference in median Day 8 peripheral or bone marrow blast response. Plasma VCR pharmacokinetic parameters did not predict outcome. However, in B-ALL, Day 33 MRD negative patients and patients in continuous complete remission had significantly higher median intracellular VCR 24h  levels (P=0.03 and P=0.04 respectively). The median VCR 24h  intracellular levels were similar among the common genetic subtypes of ALL (P=0.4). Patients homozygous for wild type ABCB1 2677GG had significantly higher median intracellular VCR 24h  (P= 0.04) than 2677TT.
CONCLUSIONS


We showed that in childhood B-ALL, the intracellular VCR 24h  levels in lymphoblasts affected treatment outcomes. The intracellular VCR 24h  level was independent of leukaemia subtype but dependent on host ABCB1 G2677T genotype.",2020,"Between 15 min versus 3-h infusion schedules, there was no significant difference in median Day 8 peripheral or bone marrow blast response.","['childhood B-lymphoblastic leukaemia', '429 children with newly diagnosed ALL to 15 min versus 3-h infusion for the first dose of', 'Patients homozygous for wild type', 'n=135 patients) and intracellular (n=66 patients) pharmacokinetic studies']","['Vincristine (VCR', 'VCR plasma', 'VCR']","['PK parameters and intracellular VCR levels', 'median VCR 24h  intracellular levels', 'VCR PK parameters and intracellular VCR levels', 'median intracellular VCR 24h  levels', 'median intracellular VCR', 'median Day 8 peripheral or bone marrow blast response', 'Plasma VCR pharmacokinetic parameters', 'intracellular VCR 24h  level']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023448', 'cui_str': 'Lymphoid leukemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0201734', 'cui_str': 'Pharmacokinetic study'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",429.0,0.0607707,"Between 15 min versus 3-h infusion schedules, there was no significant difference in median Day 8 peripheral or bone marrow blast response.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Edwynn Kean Hui', 'Initials': 'EKH', 'LastName': 'Chiew', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Yok Moi', 'Initials': 'YM', 'LastName': 'Koo', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'How Sung', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Hai Peng', 'Initials': 'HP', 'LastName': 'Lin', 'Affiliation': 'Sime Darby Medical Centre, Subang Jaya, Malaysia.'}, {'ForeName': 'Ah Moy', 'Initials': 'AM', 'LastName': 'Tan', 'Affiliation': ""Department of Paediatrics, KK Women's & Children's Hospital, Singapore, Singapore.""}, {'ForeName': 'Thuan Chong', 'Initials': 'TC', 'LastName': 'Quah', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Shirley Kow Yin', 'Initials': 'SKY', 'LastName': 'Kham', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Cher', 'Initials': 'BC', 'LastName': 'Goh', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore, Singapore.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Ariffin', 'Affiliation': 'University of Malaya Cancer Research Institute, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Allen Eng-Juh', 'Initials': 'AE', 'LastName': 'Yeoh', 'Affiliation': 'VIVA-NUS Centre for Translational Research in Acute Leukaemia, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",British journal of clinical pharmacology,['10.1111/bcp.14596']
3151,33037726,Comparison of the efficacy and safety of different doses of nifekalant in the instant cardioversion of persistent atrial fibrillation during radiofrequency ablation.,"Nifekalant has been used in the treatment of atrial arrhythmia recently. However, there is no consensus on the preferable nifekalant dose to treat atrial fibrillation (AF). The purpose of this study was to explore efficacy and safety of different doses of nifekalant in the cardioversion of persistent AF. The study was a single-center, randomized controlled trial. All subjects received nifekalant or placebo intravenously, and the nifekalant was given at the dosage of 0.3, 0.4 or 0.5mg/kg. Primary efficacy endpoint: compared with 0.3mg group, the rate of cardioversion to sinus rhythm from AF in 0.4mg and 0.5mg group was higher. The 0.4mg/kg and 0.5mg/kg doses were associated with a similar magnitude of efficacy (P>0.05). Secondary efficacy endpoint: termination rates of AF in the group of 0.4mg and 0.5mg were higher than 0.3mg. Primary safety endpoint: the rate of Torsades de Pointes or ventricular fibrillation was numerically lower in the 0.4mg group than 0.5mg group (P=0.02). Secondary safety endpoint: The rates of the majority of other common drug-related adverse events in the group of 0.5mg and 0.4mg were higher than the 0.3mg group. A 0.4mg/kg dose of intravenous nifekalant may be recommended during the radiofrequency ablation for persistent AF considering the benefit-risk profile. (ClinicalTrials.gov number: NCT04209959).",2020,Secondary efficacy endpoint: termination rates of AF in the group of 0.4mg and 0.5mg were higher than 0.3mg.,[],"['radiofrequency ablation', 'nifekalant or placebo']","['efficacy and safety', 'rates of the majority of other common drug-related adverse events', 'efficacy endpoint: termination rates of AF', 'rate of cardioversion to sinus rhythm', 'rate of Torsades de Pointes or ventricular fibrillation']",[],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C2350374', 'cui_str': 'nifekalant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}]",,0.0413866,Secondary efficacy endpoint: termination rates of AF in the group of 0.4mg and 0.5mg were higher than 0.3mg.,"[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Zirong', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Jinzhu', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Qinmei', 'Initials': 'Q', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'JianHua', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Juxiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, the Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13513']
3152,33037795,"Evaluation of the primary stability in dental implants placed in low density bone with a new drilling technique, Osseodensification: an in vitro study.","BACKGROUND


Primary stability is an important key determinant of implant osseointegration. We investigated approaches to improve primary implant stability using a new drilling technique termed osseodensification (OD), which was compared with the conventional under-drilling (UD) method utilized for low-density bones.
MATERIAL AND METHODS


We placed 55 conical internal connection implants in each group, in 30 low-density sections of pig tibia. The implants were placed using twist drill bits in both groups; groups Under Drilling (UD) and Osseodensification (OD) included bone sections subjected to conventional UD and OD drilling, respectively. Before placing the implants, we randomized the bone sections that were to receive these implants to avoid sample bias. We evaluated various primary stability parameters, such as implant insertion torque and resonance frequency analysis (RFA) measurements.
RESULTS


The results showed that compared with implants placed using the UD technique, those placed using the OD technique were associated with significantly higher primary stability. The mean insertion torque of the implants was 8.87±6.17 Ncm in group 1 (UD) and 21.72±17.14 Ncm in group 2 (OD). The mean RFA was 65.16±7.45 ISQ in group 1 (UD) and 69.75±6.79 ISQ in group 2 (OD).
CONCLUSIONS


The implant insertion torque and RFA values were significantly higher in OD group than in UD. Therefore, compared with UD, OD improves primary stability in low-density bones (based on torque and RFA measurements).",2020,The mean insertion torque of the implants was 8.87±6.17 Ncm in group 1 (UD) and 21.72±17.14 Ncm in group 2 (OD).,"['We placed 55 conical internal connection implants in each group, in 30 low-density sections of pig tibia']","['new drilling technique termed osseodensification (OD', 'UD, OD', 'new drilling technique, Osseodensification', 'Under Drilling (UD) and Osseodensification (OD) included bone sections subjected to conventional UD and OD drilling, respectively']","['implant insertion torque and RFA values', 'mean insertion torque', 'implant insertion torque and resonance frequency analysis (RFA) measurements', 'mean RFA']","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C4505213', 'cui_str': 'Resonance Frequency Analysis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0522113,The mean insertion torque of the implants was 8.87±6.17 Ncm in group 1 (UD) and 21.72±17.14 Ncm in group 2 (OD).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Barberá-Millán', 'Affiliation': 'Department of Surgery and Oral Implantology Faculty of Medicine and Health Sciences Catholic University of Valencia Calle Quevedo nº2, 46001, Valencia, Spain jabarmi14@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Larrazábal-Morón', 'Affiliation': ''}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Enciso-Ripoll', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pérez-Pevida', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chávarri-Prado', 'Affiliation': ''}, {'ForeName': 'M-D', 'Initials': 'MD', 'LastName': 'Gómez-Adrián', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.24231']
3153,33037801,"The efficacy of etodolac and ibuprofen, regarding gender, on pain, edema and trismus after impacted lower third molar surgery: A randomized prospective clinical split-mouth study.","BACKGROUND


This study aimed to conduct a randomized prospective study about the efficacy of etodolac and ibuprofen on trismus, pain and edema regarding gender of patients submitted to impacted lower third molar teeth extraction.
MATERIAL AND METHODS


Thirty patients aging between 16 and 35 year-old were submitted to the exodontia of impacted lower third molars. During the postoperative period, patients received nine ibuprofen (600 mg) or etodolac (300 mg) pills via oral administration immediately after surgery and repeated doses every eight hours during three days. Patients were evaluated regarding pain, trismus and edema.
RESULTS


Sixteen men and fourteen women participated of the study. No statistical difference was established regarding gender according to the evaluated parameters. However, etodolac use showed better results regarding pain, trismus and edema.
CONCLUSIONS


Pain, edema and trismus after impacted third molars extraction were not influenced by gender.",2020,No statistical difference was established regarding gender according to the evaluated parameters.,"['after impacted lower third molar surgery', 'trismus, pain and edema regarding gender of patients submitted to impacted lower third molar teeth extraction', 'Sixteen men and fourteen women participated of the study', 'Thirty patients aging between 16 and 35 year-old were submitted to the exodontia of impacted lower third molars']","['nine ibuprofen', 'etodolac', 'etodolac and ibuprofen']","['pain, edema and trismus', 'pain, trismus and edema', 'Pain, edema and trismus']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",30.0,0.0266139,No statistical difference was established regarding gender according to the evaluated parameters.,"[{'ForeName': 'L-D', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'Department of Surgery and Integrated Clinics Araçatuba School of Dentistry - UNESP Rua José Bonifácio, 1193 CEP 16015-050 São Paulo, Brazil daniela.ponzoni@unesp.br.'}, {'ForeName': 'E-N', 'Initials': 'EN', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'L-P', 'Initials': 'LP', 'LastName': 'Faverani', 'Affiliation': ''}, {'ForeName': 'A-P', 'Initials': 'AP', 'LastName': 'Farnezi Bassi', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.24082']
3154,33037803,"Effects of preemptive analgesia with intravenous acetaminophen on postoperative pain relief in patients undergoing third molar surgery: a prospective, single-blind, randomized controlled trial.","BACKGROUND


The efficacy of preemptive analgesia in managing postoperative pain remains controversial. The aim of this study was to compare the efficacy of intravenous (IV) acetaminophen administered before or immediately after the surgical extraction of an impacted mandibular third molar.
MATERIAL AND METHODS


This prospective randomized clinical trial included 120 patients. The patients were assigned to one of three groups: the preoperative-treatment group (pre-group), which received 1000 mg of IV acetaminophen 20 min before surgery; the postoperative-treatment group (post-group), which received 1000 mg of IV acetaminophen after surgery; the no-treatment group (control-group), which did not receive any analgesic. Rescue analgesic (60 mg loxoprofen) was issued to each patient, with instructions on self-administration if needed. For the rescue medication usage, the time of first loxoprofen usage and the total amount of loxoprofen consumption were obtained for a 17-hour period after surgery. We measured pain using the visual analogue scale at 1 hour and at 2, 3, 4, 5, and 15 hours after surgery.
RESULTS


There was no significant difference in pain level among the three groups at any time interval. However, the pre-group demonstrated significantly lower rescue analgesic consumption and longer time until initial administration.
CONCLUSIONS


Administration of IV acetaminophen before third molar surgery provides more effective pain control than postoperative administration and no treatment.",2020,There was no significant difference in pain level among the three groups at any time interval.,"['120 patients', 'patients undergoing third molar surgery']","['preemptive analgesia', 'intravenous (IV) acetaminophen', 'preoperative-treatment group (pre-group), which received 1000 mg of IV acetaminophen 20 min before surgery; the postoperative-treatment group (post-group), which received 1000 mg of IV acetaminophen after surgery; the no-treatment group (control-group), which did not receive any analgesic', 'preemptive analgesia with intravenous acetaminophen', 'IV acetaminophen', 'Rescue analgesic (60 mg loxoprofen']","['pain level', 'postoperative pain relief', 'effective pain control', 'total amount of loxoprofen consumption', 'pain using the visual analogue scale', 'rescue analgesic consumption and longer time until initial administration']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",120.0,0.171538,There was no significant difference in pain level among the three groups at any time interval.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kano', 'Affiliation': 'Graduate School of Dentistry, Osaka Dental University Kuzuhahanazono-cho 8-1, Hirakata-shi Osaka 573-1211, Japan kanoukeita@tdc.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kawamura', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Miyake', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23983']
3155,33037810,Effect of zinc on oropharyngeal mucositis in children with acute leukemia undergoing chemotherapy.,"BACKGROUND


Oropharyngeal mucositis (OM) is one of the main side-effects of oncological therapy. There is no treatment to prevent its occurrence, but some zinc-based therapies have been proven to help in decreasing its intensity. The objective of this study was to determine the effect of zinc in OM in children with acute leukemia in the early stages of oncological treatment.
MATERIAL AND METHODS


This quasi-experimental study evaluated OM in 2 groups (control group: conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management). OM severity was recorded at a two-month follow-up.
RESULTS


Forty-nine patients (26 in the control group and 23 in the experimental group) were included. The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia. The incidences of OM in the control group and the experimental group were 46.2% and 26.1%, respectively, but the difference was not significant. Based on a negative binomial regression model, females had, on average, 1.5 more days with OM (p = 0.002), and patients assigned to the experimental group had, on average, 2 less days with OM than the control group (p = 0.001). The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
CONCLUSIONS


Zinc facilitated a reduction in the severity and duration of OM; further studies focusing on children are needed to confirm the effects of this trace element.",2020,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","['children with acute leukemia in the early stages of oncological treatment', 'children with acute leukemia undergoing chemotherapy', 'The mean age of the patients was 11.1 ± 2.7 years; 65.3% had a diagnosis of pre-B acute lymphoblastic leukemia', '2 groups (control group', 'Forty-nine patients (26 in the control group and 23 in the experimental group) were included']","['conventional hospital management, and experimental group: administration of 50 mg of zinc gluconate daily plus conventional hospital management', 'zinc in OM', 'zinc']","['incidences of OM', 'severity and duration of OM', 'mean score on the WHO scale', 'pain score', 'OM severity', 'oropharyngeal mucositis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023485', 'cui_str': 'Leukemia, Pre-B-Cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019948', 'cui_str': 'Administration, Hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1290331', 'cui_str': 'Oropharyngeal mucositis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0392876,"The pain score was higher in the control group (p = 0.0009), as was the mean score on the WHO scale (p = 0.0012).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutiérrez-Vargas', 'Affiliation': 'Oncology Department National Institute of Pediatrics, Health Secretary Insurgentes Sur 3700-C, Insurgentes Cuicuilco Coyoacan, Mexico City, 04530 mzapatatarres@gmail.com.'}, {'ForeName': 'M-Á', 'Initials': 'MÁ', 'LastName': 'Villasis-Keever', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portilla-Robertson', 'Affiliation': ''}, {'ForeName': 'I-D', 'Initials': 'ID', 'LastName': 'Ascencio-Montiel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zapata-Tarrés', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23798']
3156,33037918,Palbociclib (PD-0332991) pharmacokinetics in subjects with impaired renal function.,"PURPOSE


This publication describes an evaluation of the impact of different degrees of renal impairment on the pharmacokinetics and safety of palbociclib after a single 125-mg oral dose.
METHODS


Thirty-one subjects were assigned to different renal function groups. Serial blood sampling for pharmacokinetics was performed up to 120 h and 168 h post-palbociclib dose for subjects with normal and impaired renal function, respectively. A separate blood sample was collected at pre-dose and 8 h after dosing to measure plasma protein binding. Plasma palbociclib was measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Plasma protein binding samples were processed by equilibrium dialysis and measured by a validated LC-MS/MS method.
RESULTS


Plasma palbociclib exposure was higher in subjects with renal impairment than in subjects with normal renal function; however, there were no marked differences in exposure across subjects with mild, moderate, and severe renal impairment. Total plasma exposure AUC inf  increased by 39%, 42%, and 31% with mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. Peak exposure C max  increased by 17%, 12%, and 15% for mild, moderate, and severe impairment, respectively. There was no obvious trend in the mean f u  with worsening renal function. The PBPK model adequately described palbociclib exposure observed in subjects with moderate or severe renal impairment from this study.
CONCLUSION


Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose. No dose adjustment is required in patients with renal impairment.",2020,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"['patients with renal impairment', 'subjects with impaired renal function', 'Thirty-one subjects', 'subjects with moderate or severe renal impairment from this study']",['Palbociclib'],"['renal function', 'Plasma palbociclib', 'severe renal impairment', 'Total plasma exposure AUC inf', 'mean f u  with worsening renal function', 'Peak exposure C max', 'safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",31.0,0.019983,Palbociclib was safe and well-tolerated in a small population of subjects with normal and impaired renal function after a single oral 125 mg dose.,"[{'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plotka', 'Affiliation': 'Biostatistics, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': ""O'Gorman"", 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92130, USA. Diane.Wang@pfizer.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04163-4']
3157,33037961,Assessment of the Effectiveness of Group Cognitive Behavioural Therapy in Reducing Pathological Gambling.,"Pathological gambling is a developmental disorder usually associated with a continuous loss of control over gambling; it also involves a preoccupation with gambling and with obtaining money for the same purpose of gambling, irrational thinking, and a continuation of the behaviour despite being aware of its adverse consequences. This study examined the effectiveness of group cognitive-behavioural therapy (GCBT) on pathological gambling among Nigerian students. The study used a group randomised controlled trial design to assign participants to intervention and control groups. A total of 40 undergraduate students, aged 18-30, were classified as pathological gamblers (participants) in this study. Participants completed self-report scales titled South oaks gambling screen and Gambling Symptom Assessment Scale at three-time points. The intervention lasted for 8 weeks. The data collected were statistically analysed using repeated-measures ANOVA. Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up. The study concluded that group cognitive-behavioural therapy is impactful therapy in reducing pathological gambling among students. It has also validated the effectiveness of cognitive-behavioural therapy in altering erroneous thoughts and replacing it with a better alternative realistic way of thinking.",2020,Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up.,"['40 undergraduate students, aged 18-30, were classified as pathological gamblers (participants) in this study', 'pathological gambling among students', 'pathological gambling among Nigerian students']","['cognitive-behavioural therapy', 'GCBT', 'group cognitive-behavioural therapy (GCBT', 'Group Cognitive Behavioural Therapy']","['self-report scales titled South oaks gambling screen and Gambling Symptom Assessment Scale', 'Pathological Gambling', 'symptoms of pathological gambling']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030662', 'cui_str': 'Compulsive gambling'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0030662', 'cui_str': 'Compulsive gambling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0246291,Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up.,"[{'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria. moses.ede@unn.edu.ng.'}, {'ForeName': 'Joachim C', 'Initials': 'JC', 'LastName': 'Omeje', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Damian Chijioke', 'Initials': 'DC', 'LastName': 'Ncheke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria. chijioke.ncheke@unn.edu.ng.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Agah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Ngozi H', 'Initials': 'NH', 'LastName': 'Chinweuba', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Chijioke Virgilus', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}]",Journal of gambling studies,['10.1007/s10899-020-09981-y']
3158,33037974,Event-related potential (P300): the effects of levetiracetam in cognitive performance.,"BACKGROUND


The current study is a reanalysis in the time domain of EEG data collection in healthy adults during an oddball paradigm using levetiracetam (LEV) vs. placebo acute administration. Specifically, the event-related potential (ERP) technique provides a tool for exploring the EEG responses to a specific event/stimulus. One of the ERP components widely studied is the P300 component, which is associated with the last stage of information processing and a general measurement of ""cognitive efficiency.""
METHODS


The sample was composed of thirteen healthy right-handed individuals randomized to participate under two conditions: LEV and placebo. Electrophysiological measures were collected before and after drug intake. We explored the oddball paradigm, which is commonly used with healthy individuals to investigate the stages of information processing.
RESULTS


The electrophysiological results showed a main effect of condition on P300 amplitude for the frontal (F3, Fz, F4), central (C3, Cz, C4), and parietal electrodes (P3, Pz, P4). The post hoc comparisons (Scheffé's test) demonstrated the significant differences between electrodes. Regarding P300 latency, all regions represented a main effect of condition. A P300 latency reduction was observed during LEV condition compared with placebo.
CONCLUSION


Our study observed the ERP component-P300-through the variation of its amplitude and latency to evaluate a supposed higher CNS efficiency when participants were under the LEV effect. Our findings sustain this premise, mainly due to reducing in P300 latency for the LEV condition, supporting the neural efficiency hypothesis.",2020,"The electrophysiological results showed a main effect of condition on P300 amplitude for the frontal (F3, Fz, F4), central (C3, Cz, C4), and parietal electrodes (P3, Pz, P4).","['thirteen healthy right-handed individuals randomized to participate under two conditions', 'healthy adults', 'healthy individuals']","['levetiracetam', 'LEV and placebo', 'levetiracetam (LEV) vs. placebo']","['P300 amplitude for the frontal (F3, Fz, F4), central (C3, Cz, C4), and parietal electrodes (P3, Pz, P4', 'P300 latency reduction', 'ERP component']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",13.0,0.0349911,"The electrophysiological results showed a main effect of condition on P300 amplitude for the frontal (F3, Fz, F4), central (C3, Cz, C4), and parietal electrodes (P3, Pz, P4).","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Gongora', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nicoliche', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil. Eduardo.nicoliche@gmail.com.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Magalhães', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Vicente', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Brain Mapping and Functionality Laboratory, Federal University of Piauí, Parnaíba, Piauí, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'Brain Mapping and Functionality Laboratory, Federal University of Piauí, Parnaíba, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bittencourt', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Biomedical Engineering Program, COPPE, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Basile', 'Affiliation': 'Laboratory of Psychophysiology, Faculdade da Saúde, UMESP, São Paulo, Brazil.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Institute of Applied Neuroscience (INA), Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration, Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ), Rio de Janeiro, RJ, Brazil.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04786-8']
3159,33037989,Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial.,"PURPOSE


Determine the feasibility of a remotely delivered mobile health (mHealth)-supported intervention to improve diet and physical activity in hematologic malignancy survivors.
METHODS


Pilot randomized controlled trial of a 16-week intervention for improving diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group. Controls accessed the trackers without goal-setting or peer support. Everyone received standardized survivorship counseling with tailored advice from a clinician. Actigraphy and food frequency questionnaires assessed activity and diet at baseline and follow-up.
RESULTS


Forty-one participants (51.2% male; median age 45.1 years; 7.0 years from treatment) were randomized (24 intervention; 17 control). Fitbit and Healthwatch360 use were more common among intervention versus control participants (75.0% versus 70.6% and 50.0% versus 17.7% of eligible days, respectively). Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications. While no comparisons in activity or dietary outcomes between intervention versus control group met statistical significance, the intervention was associated with greater reductions in the targeted dietary factors and improvements in Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps. Participant retention at 6 months was 90.2%.
CONCLUSIONS


An intervention for cardiovascular risk reduction based on individualized goal-setting enhanced by mHealth and social media peer support was feasible and acceptable among cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS


Effective and easily disseminated strategies that improve diet and physical activity in this population are needed.
TRIAL REGISTRATION


Registered in ClinicalTrials.gov (NCT03574012) on June 29, 2018.",2020,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","['hematologic malignancy survivors', 'cancer survivors', 'Forty-one participants (51.2% male; median age 45.1\xa0years; 7.0\xa0years from treatment']","['standardized survivorship counseling', 'remotely delivered mobile health (mHealth)-supported intervention', 'diet and physical activity: individualized goal-setting (daily steps, sodium, saturated fat, added sugar intake) per feedback from mHealth trackers (Fitbit for activity; Healthwatch360 for diet), supplemented by a Facebook peer support group', 'behavioral intervention using mobile health applications']","['cardiovascular risk factors', 'activity or dietary outcomes', 'Healthy Eating Index-2015 score, moderate-vigorous physical activity time, and daily steps', 'Actigraphy and food frequency questionnaires assessed activity and diet']","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0717649,"Most intervention participants (66.7%) engaged with Facebook; overall, 91.7% interacted with the study's mHealth applications.","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA. ericchow@uw.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Doody', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Chongzhi', 'Initials': 'C', 'LastName': 'Di', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Saro H', 'Initials': 'SH', 'LastName': 'Armenian', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'K Scott', 'Initials': 'KS', 'LastName': 'Baker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Tyler G', 'Initials': 'TG', 'LastName': 'Ketterl', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Kerryn W', 'Initials': 'KW', 'LastName': 'Reding', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Taylor', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Guangxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Fred Hutchinson Cancer Research Center, PO Box 19024, Mailstop M4-C308, Seattle, WA, 98109, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00949-w']
3160,33037990,Once-weekly vs. twice-weekly carfilzomib dosing in a subgroup of Japanese relapsed and refractory multiple myeloma patients from a randomized phase 3 trial (A.R.R.O.W.) and comparison with ENDEAVOR.,"A.R.R.O.W. evaluated the superiority of once-weekly carfilzomib plus dexamethasone (Kd) 20/70 mg/m 2  vs. twice-weekly Kd 20/27 mg/m 2  based on progression-free survival (PFS) in relapsed and/or refractory multiple myeloma patients. Forty Japanese patients (once-weekly arm, n = 26; twice-weekly arm, n = 14) were randomized in A.R.R.O.W. In the Japanese subgroup of A.R.R.O.W., median PFS was 14.8 months (95% confidence interval [CI], 7.5-not evaluable [NE]) and 9.7 months (95% CI, 3.8-NE) in the once- and twice-weekly arms, respectively. The overall response rate (ORR) was 73.1% (19/26; 95% CI, 52.2-88.4) and 57.1% (8/14; 95% CI, 28.9-82.3) in each arm. The adverse events (AEs) incidence was 100% in both arms. Grade ≥ 3 AE incidence was 80.8% (21/26) and 78.6% (11/14) in each arm. Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm. In exploratory unadjusted analyses of A.R.R.O.W. (once-weekly Kd 20/70 mg/m 2 ) vs. ENDEAVOR (twice-weekly Kd 20/56 mg/m 2 ), median PFS was 14.8 months vs. NE due to not yet being reached, and ORR was 73.1% (19/26) vs. 42.9% (3/7). In the Japanese subgroup, once-weekly Kd tended to improve ORR vs. twice-weekly Kd. Results from A.R.R.O.W. tended to be consistent with results from ENDEAVOR.",2020,Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm.,"['Forty Japanese patients (once-weekly arm, n\u2009=\u200926; twice-weekly arm, n\u2009=\u200914', 'relapsed and/or refractory multiple myeloma patients']",['carfilzomib plus dexamethasone (Kd'],"['fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome', 'Grade\u2009≥', 'overall response rate (ORR', 'ORR', 'adverse events (AEs) incidence', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",40.0,0.282537,Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm.,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, Tokyo, 190-0014, Japan. ntakezak@tdmc.hosp.go.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Shibayama', 'Affiliation': 'Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Handa', 'Affiliation': 'Gunma University Graduate School, Maebashi, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Hagiwara', 'Affiliation': ""Tokyo Women's University, Tokyo, Japan.""}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Tokushima Prefectural Central Hospital, Tokushima, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kosugi', 'Affiliation': 'Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ri', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Sugiura', 'Affiliation': 'Toyohashi Municipal Hospital, Toyohashi, Japan.'}, {'ForeName': 'Ilseung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",International journal of hematology,['10.1007/s12185-020-03013-6']
3161,33038005,General Practitioner Use of Generically Substitutable Inhaler Devices and the Impact of Training on Device Mastery and Maintenance of Correct Inhaler Technique.,"INTRODUCTION


Generic substitution of inhaler devices is a relatively new phenomenon. The best patient outcomes associated with generic substitution occur when prescribers obtain consent from their patients to prescribe a generic inhaler and also teach their patient how to correctly use the new device. To date, no prospective observational study has assessed the level of training required for general practitioners (GPs) to demonstrate correct inhaler technique using two dry powder inhaler devices delivering fixed-dose combination budesonide/formoterol therapy. This study aims to (1) determine the level of training required for GPs to master and maintain correct IT when using two different dry powder inhalers that are able to be substituted in clinical practice and (2) determine the number and types of errors made by GPs on each device and inhaler device preference at each training visit.
METHOD


A randomized, parallel-group cross-over study design was used to compare the inhaler technique of participants with a Spiromax ®  placebo device and a Turbuhaler ®  placebo device. This study consisted of two visits with each participant over a period of 4 ± 1 weeks (visit 1 and visit 2). A total of six levels of assessment and five levels of training were implemented as required. Level 1, no instruction; level 2, following use of written instruction; level 3, following viewing of instructional video; level 4, expert tuition from the researcher; level 5/level 6, repeats of expert tuition from the researcher when required. Participants progressed through each level and stopped at the point at which they demonstrated device mastery. At each level, trained researchers assessed the inhaler technique of the participants. Participants were also surveyed about their previous inhaler use and training.
RESULTS


In total, 228 GPs participated in this study by demonstrating their ability to use a Turbuhaler ®  and a Spiromax ®  device. There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data). All but one participant had demonstrated correct inhaler technique for both devices by level 3(instructional video). There was a significant difference between the proportion of participants who demonstrated maintenance of device mastery with the Turbuhaler ®  compared with the Spiromax ®  at visit 2, level 1 (127/177 (72%) versus 151/177 (85%) respectively, p = 0.003; McNemar's test of paired data). All but two participants achieved device mastery by level 3, visit 2. More participants reported previous training with the Turbuhaler ®  than with Spiromax ® .
DISCUSSION


This study demonstrates that GPs are able to equally demonstrate correct use of the Turbuhaler ®  and Spiromax ®  devices, even though most had not received training on a Spiromax ®  device prior to this study. The significance of being able to demonstrate correct technique on these two devices equally has ramifications on practice and supported generic substitution of inhaler devices at the point of prescribing, as the most impactful measure a GP can take to ensure effective use of inhaled medicine is the correct demonstration of inhaler technique.",2020,"There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data).","['participants with a\xa0Spiromax ®  placebo device and a Turbuhaler ®  placebo device', 'general practitioners (GPs']",['budesonide/formoterol therapy'],['device mastery'],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",228.0,0.128921,"There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data).","[{'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Cvetkovski', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. biljana.cvetkovski@sydney.edu.au.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hespe', 'Affiliation': 'School of Medicine, The University of Notre Dame Australia, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kritikos', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Azzi', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sinthia', 'Initials': 'S', 'LastName': 'Bosnic-Anticevich', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}]",Pulmonary therapy,['10.1007/s41030-020-00131-8']
3162,33038017,A validated photonumeric scale for infraorbital dark circles and its application in evaluating the efficacy of a cosmetic treatment product in a split-face randomised clinical trial.,"OBJECTIVE


Due to their complex aetiology and periodicity, dark circles are difficult to characterise and measure, with current assessment techniques relying on specialist equipment, image analysis or proprietary grading scales. There is therefore a need to develop and validate a photonumeric scale for assessing infraorbital dark circles, which can provide an objective and consumer relevant tool for evaluating this condition and the efficacy of treatment products and procedures.
METHODS


A panel of expert clinical evaluators reviewed approximately three thousand facial photographs collected over a 5-year period and selected images representing a dynamic range of dark circles. A 10-point photonumeric scale was created, with corresponding descriptors and images for each grade of the scale. To rigorously validate the scale, linearity, sensitivity and precision were assessed by colorimetry and in-clinic evaluation. Reproducibility was assessed photographically with both experienced and inexperienced clinical evaluators, while intra-grader repeatability was assessed live in-clinic. The scale was then employed in a split-face randomised clinical trial on 58 subjects to evaluate the efficacy of a cosmetic treatment product over 8 weeks.
RESULTS


Colour analysis of the images showed the scale was linear, with statistically significant correlations observed when colour data (CIElab; Individual Typology Angle) were plotted against the corresponding grades (r >0.9, p<0.001). Colour difference (Delta E) was calculated between the infraorbital zone and the surrounding skin, and when data were plotted against the grades, a statistically significant correlation was observed (r =0.99, p<0.01). The magnitude of the Delta E suggested that changes in grade are visibly perceptible to the human eye and therefore the scale is sensitive and clinically relevant. Inter-grader reproducibility showed strong correlation (0.96) and >90% agreement between experienced evaluators, while intra-grader repeatability assessment showed >90% perfect agreement between grades. Use of this scale in a clinical trial demonstrated the efficacy of a cosmetic product, with a mean statistically significant (p<0.001) decrease in grade of 0.74 compared to baseline, and 0.59 versus the untreated control, after 8 weeks of treatment.
CONCLUSION


Our photonumeric scale for infraorbital dark circles is sensitive and robust and provides an objective and easy-to-use tool to evaluate dark circles and their treatment.",2020,"Inter-grader reproducibility showed strong correlation (0.96) and >90% agreement between experienced evaluators, while intra-grader repeatability assessment showed >90% perfect agreement between grades.",['58 subjects'],[],"['Colour difference (Delta E', 'Reproducibility']",[],[],"[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",58.0,0.0305529,"Inter-grader reproducibility showed strong correlation (0.96) and >90% agreement between experienced evaluators, while intra-grader repeatability assessment showed >90% perfect agreement between grades.","[{'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': ""O'Mahony"", 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Sladen', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Crone', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Banner', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Newton', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Marlow', 'Affiliation': 'Walgreens Boots Alliance, Thane Road, Nottingham, NG90 1BS, UK.'}, {'ForeName': 'Summer F', 'Initials': 'SF', 'LastName': 'Acevedo', 'Affiliation': 'SGS Stephens, 1801 N. Glenville Drive, Richardson, Texas, 75081, USA.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Jiang', 'Affiliation': 'SGS Stephens, 1801 N. Glenville Drive, Richardson, Texas, 75081, USA.'}]",International journal of cosmetic science,['10.1111/ics.12668']
3163,33038018,Training load but not fatigue affects cross-education of maximal voluntary force.,"The purpose of this study was to determine the effects of training load (25% vs. 75% of one repetition maximum (1RM)) and fatigue (failure vs. non-failure) during four weeks of unilateral knee extension resistance training (RT) on maximal voluntary force in the trained and the untrained knee extensors. Healthy young adults (n=42) were randomly assigned to control (CON, n=9, 24±4.3y), low-load RT to failure (LLF, n=11, 21±1.3y, three sets to failure at 25% of 1RM), high-load RT to failure (HLF, n=11, 21±1.4y, three sets to failure at 75% of 1RM), and high-load RT without failure (HLNF, n=11, 22±1.5y, six sets of five repetitions at 75% of 1RM) groups. Before and after the four weeks of training, 1RM, maximal voluntary isometric force (MVIC) and corticospinal excitability (CSE) were measured. 1RM in the trained (20%, d=0.70, 15%, d=0.61) and the untrained knee extensors (5%, d=0.27, 6%, d=0.26) increased only in the HLF and HLNF groups, respectively. MVIC force increased only in the trained leg of the HLF (5%, d=0.35) and HLNF groups (12%, d=0.67). CSE decreased in the VL of both legs in the HLNF group (-19%, d=0.44) and no changes occurred in the RF. In conclusion, high- but not low-load RT improves maximal voluntary force in the trained and the untrained knee extensors and fatigue did not further enhance these adaptations. Voluntary force improvements were unrelated to CSE changes in both legs.",2020,"MVIC force increased only in the trained leg of the HLF (5%, d=0.35) and HLNF groups (12%, d=0.67).","['Healthy young adults (n=42', 'untrained knee extensors']",['unilateral knee extension resistance training (RT'],"['maximal voluntary force', 'CSE', 'MVIC force', '1RM', '1RM, maximal voluntary isometric force (MVIC) and corticospinal excitability (CSE', 'untrained knee extensors']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",42.0,0.0298528,"MVIC force increased only in the trained leg of the HLF (5%, d=0.35) and HLNF groups (12%, d=0.67).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Colomer-Poveda', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fariñas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, A Coruna, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, A Coruna, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Márquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport, Catholic University of Murcia (UCAM), Murcia, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13844']
3164,33038022,The effects of a brief hope intervention on decision-making in chronic kidney disease patients: A study protocol for a randomized controlled trial.,"AIMS


This study describes the study protocol of a manualized brief hope intervention that is based on the theoretical proposition - hope theory.
BACKGROUND


Patients with stage 5 chronic kidney disease often had decisional regret when facing the tension of treatment alternatives between dialysis initiation and palliative care. Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals. Nevertheless, little is known about the effect of hope on decisional conflict and its influences to the quality of life in these chronic kidney disease patients.
DESIGN


This study is a single-blinded, randomized controlled trial.
METHODS


Participants will be recruited from a regional hospital (approved in April 2018). They will be randomly assigned in equal numbers to either the brief hope intervention or the control arm on completion of the baseline assessment on the possible need of dialysis initiation. Participants in the intervention group will receive the pre-dialysis education and a 4-week Brief Hope Intervention [consisting of four sessions at weekly intervals (two face-to-face sessions and two telephone follow-up sessions in between)], while those allocated to the control arm will receive the renal education and social chats. Outcome measures will be carried out prior to the intervention (baseline), immediately, and 1 month after the intervention. These consist of the hope level, decisional conflict, and quality of life. Healthcare resources use data will be reported.
IMPACT


The study results have the potential to add scientific evidence to the research-tested programme when developing renal services integral to multimodal care management to optimize decision-making and attain better health outcomes.",2020,"Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals.","['chronic kidney disease patients', 'Patients with stage 5 chronic kidney disease often had decisional regret', 'Participants will be recruited from a regional hospital (approved in April 2018']","['pre-dialysis education', 'brief hope intervention', 'control arm will receive the renal education and social chats']",[],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2316810', 'cui_str': 'Chronic kidney disease stage 5'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}]",[],,0.0485543,"Hope has been found to account for therapeutic changes in clients with depressive symptoms, heightens positive expectations, and striving to accomplish chosen goals.","[{'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Suet Lai', 'Initials': 'SL', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Ching Ping', 'Initials': 'CP', 'LastName': 'Kwok', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Yuen Ping', 'Initials': 'YP', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}, {'ForeName': 'Ping Nam', 'Initials': 'PN', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Geriatrics, Kwong Wah Hospital, Hong Kong, China.'}]",Journal of advanced nursing,['10.1111/jan.14520']
3165,33038051,Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial.,"Kidney transplant recipients are at risk of developing important adverse effects after transplantation. The objective of this study was to investigate the effects of a 10-week supervised resistance exercise-based intervention in kidney transplant recipients. Sixteen participants were randomized to a training (n=8, 49.7 ± 9.6 years) or control group (n=8, 48.6 ± 10.6 years). The primary endpoint was health-related quality of life (HRQOL) evaluated through the Kidney Disease Quality of Life Short-Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters. Endpoints were assessed at baseline and after 10 weeks. Resistance exercise significantly increased (p<0.05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (p=0.050). Further, exercise benefits were observed for 6-MWD (9 and 1% for the training and control groups, respectively; p<0.001), handgrip strength (7 and -1%; p=0.005), 60-STS repetitions (18 and -7%; p<0.001) and 8-foot up and go test performance time (-5 and 6%; p=0.010). No between-groups differences (p>0.05) were found for the remaining endpoints. There were no adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events or hospitalizations related to the intervention. In conclusion, 10 weeks of supervised resistance training is enough to improve quality of life and physical performance without side effects such as musculoskeletal injuries, hypoglycemic episodes, cardiovascular events or hospitalizations related to the intervention in kidney transplant recipients.",2020,Resistance exercise significantly increased (p<0.05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (p=0.050).,"['Kidney transplant recipients', 'Sixteen participants were randomized to a training (n=8, 49.7 ± 9.6 years) or control group (n=8, 48.6 ± 10.6 years', 'kidney transplant recipients']","['supervised resistance exercise-based intervention', 'supervised resistance training', 'resistance training program']","['6-MWD', 'handgrip strength', 'adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events or hospitalizations', '60-STS repetitions', 'Resistance exercise', 'health-related quality of life (HRQOL) evaluated through the Kidney Disease Quality of Life Short-Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters', 'quality of life and physical performance']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",16.0,0.0358587,Resistance exercise significantly increased (p<0.05) some SF-36 domains and tended to induce improvements in one specific KDQOL-SF domain (p=0.050).,"[{'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Hernández Sánchez', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, School of Sports Science, University of Granada.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Carrero', 'Affiliation': 'Division of Renal Medicine and Baxter Novum, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Javier S', 'Initials': 'JS', 'LastName': 'Morales', 'Affiliation': 'Universidad Europea de Madrid, Faculty of Sport Science, Madrid, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, School of Sports Science, University of Granada.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13853']
3166,33038062,"Efficacy and Safety of E6011, an Anti-Fractalkine Monoclonal Antibody, in Active Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Results of a Randomized, Double-blind, Placebo-controlled Phase 2 study.","OBJECTIVE


Evaluate the efficacy and safety of E6011, a humanized IgG2 monoclonal antibody against human fractalkine (FKN), in a phase 2, double-blind, placebo-controlled study in rheumatoid arthritis (RA) patients.
METHODS


Patients with moderate to severe RA with inadequate response to methotrexate (MTX) were randomly assigned to a placebo or E6011 100-mg, 200-mg, or 400/200-mg group at a 2:1:2:2 ratio. During the 24-week period, patients received the study drug subcutaneously at weeks 0, 1, 2, and then every 2 weeks. The primary endpoint was the American College of Rheumatology (ACR)20 response at week 12.
RESULTS


Study drugs were administered to 190 patients (54: placebo; 28: 100-mg; 54: 200-mg; 54: 400/200-mg), and 169 patients completed treatment. A significant difference from placebo was not found in ACR20 response at week 12 (37.0%, 39.3%, 48.1%, and 46.3% in placebo, 100-mg, 200-mg, and 400/200-mg groups, respectively, at nonresponder imputation). As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively). Subsequent exploratory subgroup analysis revealed greater efficacy of E6011, particularly in subjects with higher baseline proportion of CD16 +  monocytes; their ACR20 responses at week 24 were 30.0% (placebo), 46.7% (100-mg), 57.7% (200-mg), and 69.6% (400/200-mg). E6011 administered for 24 weeks was well tolerated.
CONCLUSION


This is the first evidence that E6011, a novel cell trafficking inhibitor targeting the FKN-CX 3  CR1 interaction, is modestly effective at 24 weeks treatment in RA patients, although the primary endpoint was not met.",2020,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","['rheumatoid arthritis (RA) patients', '169 patients completed treatment', 'Patients with moderate to severe RA with inadequate response to', 'Active Rheumatoid Arthritis Patients with Inadequate Response to', '190 patients (54']","['methotrexate (MTX', 'humanized IgG2 monoclonal antibody against human fractalkine (FKN', 'Methotrexate', 'placebo', 'Placebo']","['American College of Rheumatology (ACR)20 response', 'ACR20 response', 'tolerated']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0020856', 'cui_str': 'Immunoglobulin IgG2'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0535298', 'cui_str': 'Fractalkine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",190.0,0.476423,"As a secondary endpoint, ACR20 response in the 200-mg and 400/200-mg groups attained statistical significance at week 24 (35.2%, 39.3%, 53.7%, and 57.4%, respectively).","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Rheumatology, Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nanki', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisanori', 'Initials': 'H', 'LastName': 'Umehara', 'Affiliation': 'Division of Rheumatology and Immunology, Nagahama City Hospital, Shiga, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yasuda', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Hyogo, Japan.'}, {'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Tago', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yasumi', 'Initials': 'Y', 'LastName': 'Kitahara', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawakubo', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Torii', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Hojo', 'Affiliation': 'Eisai Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kawano', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Hyogo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'KAN Research Institute, Inc, Kobe, Hyogo, Japan.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41555']
3167,33038066,A high salt meal does not impair cerebrovascular reactivity in healthy young adults.,"A high sodium (Na +  ) meal impairs peripheral vascular function. In rodents, chronic high dietary Na +  impairs cerebral vascular function, and in humans, habitual high dietary Na +  is associated with increased stroke risk. However, the effects of acute high dietary Na +  on the cerebral vasculature in humans are unknown. The purpose of this study was to determine if acute high dietary Na +  impairs cerebrovascular reactivity in healthy adults. Thirty-seven participants (20F/17M; 25 ± 5 years; blood pressure [BP]: 107 ± 9/61 ± 6 mm Hg) participated in this randomized, cross-over study. Participants were given a low Na +  meal (LSM; 138 mg Na +  ) and a high Na +  meal (HSM; 1,495 mg Na +  ) separated by ≥ one week. Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ) were measured pre- (baseline) and 60 min post-prandial. Cerebrovascular reactivity was assessed by determining the percent change in middle cerebral artery velocity to hypercapnia (via 8% CO 2  , 21% oxygen, balance nitrogen) and hypocapnia (via mild hyperventilation). Peripheral vascular function was measured using brachial artery flow-mediated dilation (FMD). Changes in serum Na +  were greater following the HSM (HSM: Δ1.6 ± 1.2 mmol/L vs. LSM: Δ0.7 ± 1.2 mmol/L, p < .01). Cerebrovascular reactivity to hypercapnia (meal effect: p = .41) and to hypocapnia (meal effect: p = .65) were not affected by the HSM. Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74). These data suggest that a single high Na +  meal does not acutely impair cerebrovascular reactivity, and suggests that despite prior findings, a single high Na +  meal does not impair peripheral vascular function in healthy adults.",2020,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","['healthy young adults', 'Thirty-seven participants (20F/17M; 25\xa0±\xa05\xa0years; blood pressure [BP]: 107\xa0±\xa09/61\xa0±\xa06\xa0mm\xa0Hg', 'healthy adults']","['high Na +  meal (HSM; 1,495\xa0mg Na +  ) separated by\xa0≥\xa0one week', 'sodium (Na +  ) meal', 'dietary Na ', 'low Na +  meal (LSM; 138']","['Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ', 'Cerebrovascular reactivity to hypercapnia', 'Peripheral vascular function', 'brachial artery flow-mediated dilation (FMD', 'middle cerebral artery velocity to hypercapnia', 'cerebrovascular reactivity', 'Cerebrovascular reactivity', 'Changes in serum Na ', 'peripheral vascular function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.0392972,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14585']
3168,33034983,Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study: Erratum.,,2020,,[],['Robotic-Assisted Laparoscopic Surgery'],[],[],"[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.164693,,[],Anesthesia and analgesia,['10.1213/ANE.0000000000004640']
3169,33035067,Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior.,"Objectives:  Parent management training is an effective treatment for disruptive behavior disorders but it is often underutilized in clinical settings. Access to care is limited due to logistical barriers as well as limited service availability. This study examines in an open trial the acceptability, feasibility, and clinical effects of a digital parent management training intervention that includes videoconference coaching, called ""Tantrum Tool.""  Methods:  Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention. The primary symptom measure was the Disruptive Behavior Rating Scale (DBRS), and the secondary outcome measure was the Affective Reactivity Index (ARI) completed by the primary caregiver before and after treatment.  Results:  Treatment retention was high (80%), and parents reported a high level of satisfaction with the program. There was a significant reduction in the mean DBRS score from 13.5 ± 5.5 at baseline to 7.3 ± 3.4 at endpoint,  p  < 0.001. There was also a significant reduction in the mean ARI irritability score from 7.2 ± 2.6 at baseline to 3.75 ± 2.1 at endpoint,  p  < 0.01.  Conclusions:  This open pilot study supports the feasibility and acceptability of a digital parent training program for young children with disruptive behavior. Findings provide preliminary support for a clinically meaningful reduction of both disruptive behavior and irritability. Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children. ClinicalTrials.gov: NCT03697837.",2020,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"['young children', 'Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention', 'young children with disruptive behavior']","['Parent management training', 'Online Parent Training', 'digital parent management training intervention', 'digital parent training program']","['mean DBRS score', 'Affective Reactivity Index (ARI', 'Disruptive Behavior Rating Scale (DBRS', 'mean ARI irritability score', 'Treatment retention']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",15.0,0.023215,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Diaz-Stransky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Zecher', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grodberg', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0089']
3170,33035082,Impact of cannabis and low alcohol concentration on divided attention tasks during driving.,"OBJECTIVE


To assess divided-attention performance when driving under the influence of cannabis with and without alcohol. Three divided-attention tasks were performed following administration of placebo, cannabis, and/or alcohol.
METHODS


Healthy adult cannabis users participated in 6 sessions, receiving combinations of cannabis (placebo/low-THC/high-THC) and alcohol (placebo/active) in randomized order, separated by washout periods of ≥1 week. At 0.5 hours post-dosing, participants performed simulator drives in the University of Iowa National Advanced Driving Simulator (NADS-1), a full vehicle cab simulator with a 360° horizontal field of view and motion base that provides realistic feedback. Drives contained repeated instances of three tasks: a side-mirror task (reaction to a triangle appearing in the side-mirrors), an artist-search task (select a specified artist from a navigable menu on the vehicle's console), and a message-reading task (read aloud a message displayed on the console). Blood THC and breath alcohol concentration (BrAC) were interpolated using individual power curves from samples collected approximately 0.17, 0.42, 1.4, and 2.3 hours post-dose. Driving measures during tasks were compared to equal-duration control periods occurring just prior to the task. Performance shifts, task completion, and lane departures were modeled relative to blood THC and BrAC using mixed-effects regression models.
RESULTS


Each 1 µg/L increase in blood THC concentration predicted increased odds of failing to complete the artist-search task (OR: 1.05, 95% CI: 1.01-1.11, p = 0.046), increased odds of selecting at least one incorrect response (OR: 1.05, 95% CI: 1.00-1.09, p = 0.041), declines in speed during the side-mirror task (0.005 m/s, 95% CI: 0.001-0.009, p = 0.023), and longer lane departure durations during the artist-search task (0.74% of task-period, 95% CI: 0.12-1.36 p = 0.020). BrAC (approximately 0.05%) was not associated with task performance, though each 0.01 g/210 L increase predicted longer departure durations during the side-mirror task (1.41% of task-period, 95% CI: 0.08-2.76, p = 0.040) and increased standard deviation of lane position in the message-reading task (0.61 cm, 95% CI: 0.14-1.08, p = 0.011).
CONCLUSIONS


With increasing medical and legal cannabis use, understanding the impact of acute cannabis use on driving performance, including divided-attention, is essential. These data indicate that impaired divided-attention performance is a safety concern.",2020,"THC concentration predicted increased odds of failing to complete the artist-search task (OR: 1.05, 95% CI: 1.01-1.11, p = 0.046), increased odds of selecting at least one incorrect response (OR: 1.05, 95% CI: 1.00-1.09, p = 0.041), declines in speed during the side-mirror task (0.005 m/s, 95% CI: 0.001-0.009, p = 0.023), and longer lane departure durations during the artist-search task (0.74% of task-period, 95% CI: 0.12-1.36 p = 0.020).","['Healthy adult cannabis users participated in 6 sessions, receiving combinations of']","['cannabis (placebo/low-THC/high-THC) and alcohol (placebo/active', 'placebo, cannabis, and/or alcohol', 'cannabis and low alcohol concentration']","['Performance shifts, task completion, and lane departures', 'blood', 'THC concentration', 'BrAC', 'longer lane departure durations', 'longer departure durations', 'standard deviation of lane position', 'Blood THC and breath alcohol concentration (BrAC']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",,0.202863,"THC concentration predicted increased odds of failing to complete the artist-search task (OR: 1.05, 95% CI: 1.01-1.11, p = 0.046), increased odds of selecting at least one incorrect response (OR: 1.05, 95% CI: 1.00-1.09, p = 0.041), declines in speed during the side-mirror task (0.005 m/s, 95% CI: 0.001-0.009, p = 0.023), and longer lane departure durations during the artist-search task (0.74% of task-period, 95% CI: 0.12-1.36 p = 0.020).","[{'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Miller', 'Affiliation': 'Department of Mathematics and Statistics, Grinnell College, Grinnell, Iowa (currently at Xavier University, Cincinnati, Ohio).'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Brown', 'Affiliation': 'National Advanced Driving Simulator, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Grinnell College, Grinnell, Iowa.'}, {'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Tibrewal', 'Affiliation': 'Grinnell College, Grinnell, Iowa.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Gaffney', 'Affiliation': 'National Advanced Driving Simulator, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Milavetz', 'Affiliation': 'National Advanced Driving Simulator, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Hartman', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, NIH, Baltimore, Maryland (currently at Monroe County Office of the Medical Examiner, Rochester, New York).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gorelick', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, NIH, Baltimore, Maryland (currently at Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Compton', 'Affiliation': 'Behavioral Safety Research, National Highway Traffic Safety Administration, Washington, DC, (currently Traffic Safety Research, North Potomac, Maryland).'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, NIH, Baltimore, Maryland (currently at Institute of Emerging Health Professions, Thomas Jefferson University, Philadelphia, Pennsylvania).'}]",Traffic injury prevention,['10.1080/15389588.2020.1814956']
3171,33035075,Acceptability and Feasibility of an Isometric Resistance Exercise Program for Abdominal Cancer Surgery: An Embedded Qualitative Study.,"Although it is recognized in the early stages of cancer recovery that changes in lifestyle including increases in physical activity improves physical function, there are no clear findings whether low versus moderate intensity activity or home or gym exercise offer optimal benefit. Isometric-resistance exercises can be carried out with very little equipment and space and can be performed while patients are bed-bound in hospital or at home. This embedded qualitative study, based in an English hospital trust providing specialist cancer care, was undertaken as a component of a feasibility trial to evaluate the acceptability and feasibility of an isometric-resistance exercise program and explore the suitability of functional assessments by drawing from the experiences of abdominal cancer patients following surgery. Telephone interviews were undertaken with 7 participants in the intervention group, and 8 interviews with the usual care group (n = 15). The gender composition consisted of 11 females and 4 males. Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40). Interviews were conducted between August 2017 and May 2018, with audio files digitally recorded and data coded using thematic framework analysis. Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete. Our study provides an insight of trial processes, participants' adherence and completion of exercise interventions, and informs the design and conduct of larger RCTs based on the experiences of abdominal cancer surgery patients.",2020,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","['11 females and 4 males', 'abdominal cancer surgery patients', 'Abdominal Cancer Surgery', 'abdominal cancer patients following surgery', ""Participants' ages ranged from 27 to 84 (M = 60.07, SD = 15.40""]","['isometric-resistance exercise program', 'Isometric Resistance Exercise Program', 'Isometric-resistance exercises']",['Acceptability and Feasibility'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0153662', 'cui_str': 'Malignant neoplasm of abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",11.0,0.034252,"Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete.","[{'ForeName': 'Ferhana', 'Initials': 'F', 'LastName': 'Hashem', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stephensen', 'Affiliation': 'Physiotherapy Department, East Kent Hospitals University Foundation NHS Trust, Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellatt-Higgins', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, United Kingdom.'}, {'ForeName': 'Ralph Nobby Peter', 'Initials': 'RNP', 'LastName': 'Hobbs', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopkins', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Woodward', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}, {'ForeName': 'Charitini', 'Initials': 'C', 'LastName': 'Stavropoulou', 'Affiliation': 'School of Health Sciences, City University, London, Northampton Square, United Kingdom.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Centre for Science and Medicine in Sport and Exercise, University of Greenwich, Gillingham, Chatham, United Kingdom.'}, {'ForeName': 'Haythem', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Maidstone, Maidstone Hospital, Hermitage Lane, Maidstone, Kent, United Kingdom.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820950855']
3172,33035103,Incidence of Silent Deep Venous Thrombosis after Laparoscopic Bariatric Surgery in Patients Who Received Combined Mechanical and Chemical Thromboprophylaxis Compared to Patients Who Received Mechanical Thromboprophylaxis Only.,"Background.  This prospective randomized study compares the incidence of silent deep venous thrombosis (DVT) among 2 groups of patients who underwent laparoscopic bariatric surgery. The first group received mechanical thromboprophylaxis only, while the second group received a combination of mechanical and chemical thromboprophylaxis.  Methods . This study included 150 morbidly obese patients who underwent primary one-stage laparoscopic bariatric surgery (sleeve gastrectomy and mini-gastric bypass) over a 6-month period. Patients were randomly assigned to 2 groups: group A (n = 75) was subjected to mechanical thromboprophylaxis in the form of perioperative elastic stockings on both lower limbs and early postoperative ambulation, and group B (n = 75) was subjected to combined mechanical thromboprophylaxis and chemical thromboprophylaxis in the form of 40 mg subcutaneous enoxaparin 12 hours before surgery and postoperative enoxaparin (40 mg subcutaneous every 24 hours) for 2 weeks. Bilateral lower limb venous duplex was done for all patients before discharge, on the second and fourth weeks postoperatively, to detect silent DVT.  Results . Nine patients out of 150 patients developed silent DVT (6%). All patients among group A were subjected to mechanical thromboprophylaxis only (12%) [ P  = .247, relative risk: .45, 95% confidence interval; .37-.62]. There was no silent DVT among group B who received combined mechanical and chemical thromboprophylaxis. No bleeding complications were reported in both groups.  Conclusion . Combined mechanical and mechanical thromboprophylaxis is effective and safe in the prevention of silent DVT after laparoscopic bariatric surgery.  Trial registration:  The trial was registered in the Thai Clinical Trials Registry (TCTR20200127002) on January 20, 2020 retrospectively.",2020,Combined mechanical and mechanical thromboprophylaxis is effective and safe in the prevention of silent DVT after laparoscopic bariatric surgery.  ,"['Thai Clinical Trials Registry (TCTR20200127002) on January 20, 2020 retrospectively', '2 groups of patients who underwent', '150 morbidly obese patients who underwent primary one-stage', 'Patients']","['Laparoscopic Bariatric Surgery', 'Mechanical Thromboprophylaxis', 'combination of mechanical and chemical thromboprophylaxis', 'mechanical thromboprophylaxis in the form of perioperative elastic stockings on both lower limbs and early postoperative ambulation, and group B (n = 75) was subjected to combined mechanical thromboprophylaxis and chemical thromboprophylaxis in the form of 40\xa0mg subcutaneous enoxaparin 12\xa0hours before surgery and postoperative enoxaparin', 'Combined mechanical and mechanical thromboprophylaxis', 'laparoscopic bariatric surgery', 'Combined Mechanical and Chemical Thromboprophylaxis', 'mechanical thromboprophylaxis', 'laparoscopic bariatric surgery (sleeve gastrectomy and mini-gastric bypass']","['silent DVT', 'Bilateral lower limb venous duplex', 'bleeding complications']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0013761', 'cui_str': 'Elastic Stockings'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",150.0,0.0503846,Combined mechanical and mechanical thromboprophylaxis is effective and safe in the prevention of silent DVT after laparoscopic bariatric surgery.  ,"[{'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Ahmad', 'Affiliation': 'Department of General Surgery, 92972Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudia Arabia.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Zayed', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, 68817Benha University, Egypt.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Faheem', 'Affiliation': 'Department of Radiology, Faculty of Medicine, 68817Benha University, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Essa', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, 68817Benha University, Egypt.'}]",Surgical innovation,['10.1177/1553350620965812']
3173,33035140,Does Baseline Serum Testosterone Influence Androgen Deprivation Therapy Outcomes in Hormone Naïve Advanced Prostate Cancer Patients?,"PURPOSE


To study baseline serum testosterone's prognostic value in hormone naïve advanced prostate cancer patients receiving continuous androgen deprivation therapy.
MATERIALS AND METHODS


The study population undergoing continuous androgen deprivation therapy (agonist or antagonist) with 1-year follow-up was pooled for post-hoc analysis from two large prospective, randomized, parallel-arm phase 3b trials (NCT00295750-Global; NCT00928434-USA). Survival end-points were evaluated for baseline serum testosterone effect as a continuous variable, and compared for low (<250 ng/dL) vs. normal ( > 250 ng/dL) groups based on the saturation model, using Kaplan Meier survival estimates, log rank test, and Cox proportional hazards regression models incorporating established clinically important baseline factors.
RESULTS


Limitations: On intention-to-treat analysis, 138 (16.5%) of 838 eligible men had baseline serum testosterone <250 ng/dL. Key cancer characteristics for low versus normal baseline serum testosterone cohorts were comparable; Gleason sum 7-10 (55 vs. 58%), stage and PSA  > 20 ng/ml categories (38% each). The lowest baseline serum testosterone quartile cut-off value was  < 282 ng/dL (n=206). Multi-variable analysis showed a significant baseline serum testosterone effect for all survival end points. For the saturation model low cut-off <250 ng/dL, significance remained for overall (HR 2.24; p <0.02) and progression free survival (HR 1.57; p <0.02), but not for time to PSA progression (HR 1.37; p=0.2).
CONCLUSIONS


Lower baseline serum testosterone was significantly associated with worse study survival end-points in hormone naïve advanced prostate cancer patients undergoing continuous medical castration. Future well-designed studies should compare continuous androgen deprivation therapy (the current gold standard) with newer alternatives, to optimize individualized management in these men.",2020,"For the saturation model low cut-off <250 ng/dL, significance remained for overall (HR 2.24; p <0.02) and progression free survival (HR 1.57; p <0.02), but not for time to PSA progression (HR 1.37; p=0.2).
","['Limitations', 'hormone naïve advanced prostate cancer patients receiving continuous androgen deprivation therapy', 'Hormone Naïve Advanced Prostate Cancer Patients', 'hormone naïve advanced prostate cancer patients undergoing continuous medical castration']",['continuous androgen deprivation therapy (agonist or antagonist'],"['baseline serum testosterone effect', 'time to PSA progression', 'progression free survival']","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",838.0,0.436718,"For the saturation model low cut-off <250 ng/dL, significance remained for overall (HR 2.24; p <0.02) and progression free survival (HR 1.57; p <0.02), but not for time to PSA progression (HR 1.37; p=0.2).
","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Consultant Urological Surgeon and 1st Chair EAU Research Foundation Clinical Studies Committee, London, UK.'}]",The Journal of urology,['10.1097/JU.0000000000001413']
3174,33035141,Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis.,"PURPOSE


To assess factors/additional morbidities related to the conversion of clamping approach during off-clamp versus on-clamp laparoscopic partial nephrectomy (LPN) in the setting of a randomized study.
MATERIALS AND METHODS


Consecutive candidates to LPN at 6 Institutions were randomized to on-clamp or off-clamp LPN. The present study analyzed 1) off-clamp arm patients, comparing the procedures finalized per-protocol without artery clamping (off-LPN) to those needing renal artery clamping (Shift-on-LPN); 2) on-clamp arm patients, comparing the procedures finalized with artery clamping (on-LPN) to those completed without clamping (Shift-off-LPN).
RESULTS


123 on-LPN versus off-LPN 126 randomized. 41 off-LPN (32.5%) converted to on-clamp. 70 on-LPN (56.9%) completed without clamping renal artery due to subjective intraoperative decision of the surgeon. Tumor size was higher in Shift-on-LPN versus off-LPN (4 vs 3, p=0.002). Vice versa, tumor size (3.7 vs 3 cm, p=0.002) and RENAL score (6 vs 5, p=0.038) were lower in Shift-off-LPN. Shift-On-LPN cases had longer operative time and higher ΔeGFR on the 1st postoperative day. Shift-off-LPN had shorter operative time. A higher proportion of patients completed on-clamp per protocol had a >25% eGFR drop on the 1st postoperative day (29.4 versus 10.3%, p=0.009), with lower ΔeGFR. Increasing tumor size and complete endophytic growth-pattern predicted Shift-on-LPN whilst preventing Shift-off-LPN. BMI >28 predicted Shift-off-LPN.
CONCLUSIONS


The likelihood of Shift-on/off-LPN relies on tumor size/complexity. The intra-operative need to convert the planned strategy seemed harmless on postoperative course. An advantage in terms of early functional outcomes does exist when avoiding artery clamping.",2020,"Vice versa, tumor size (3.7 vs 3 cm, p=0.002) and RENAL score (6 vs 5, p=0.038) were lower in Shift-off-LPN.",['Consecutive candidates to LPN at 6 Institutions'],"['clamp or off-clamp LPN', 'procedures finalized per-protocol without artery clamping (off-LPN) to those needing renal artery clamping (Shift-on-LPN', 'procedures finalized with artery clamping (on-LPN) to those completed without clamping (Shift-off-LPN', 'Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study', 'clamp versus on-clamp laparoscopic partial nephrectomy (LPN']","['operative time', 'Vice versa, tumor size', 'RENAL score', 'Tumor size']","[{'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0619394,"Vice versa, tumor size (3.7 vs 3 cm, p=0.002) and RENAL score (6 vs 5, p=0.038) were lower in Shift-off-LPN.","[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bove', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bertolo', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Big & Open Data Innovation Laboratory (BODaI-Lab), University of Brescia, Brescia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cipriani', 'Affiliation': 'Urology Department, San Carlo di Nancy Hospital, Rome, Italy.'}, {'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Leonardo', 'Affiliation': 'Department of Urology, La Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Parma', 'Affiliation': 'Department of Urology, Ospedale ""Carlo Poma"" Mantova, Mantova, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Falsaperla', 'Affiliation': 'Department of Urology, ARNAS Garibaldi Hospital, Catania, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Veneziano', 'Affiliation': 'Department of Urology and Kidney Transplantation, O.O. Riuniti BMM, Reggio Calabria, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Celia', 'Affiliation': 'Department of Urology, San Bassiano Hospital, Bassano Del Grappa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Minervini', 'Affiliation': 'Department of Urology, Careggi Hospital, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Unit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy.'}]",The Journal of urology,['10.1097/JU.0000000000001417']
3175,33035148,An E-Learning Program Improves Patients' Knowledge After Lung Transplantation.,"Background:  Adherence to immunosuppressive medicine in lung transplant recipients is associated with improved long-term survival. Patient education and support from health care providers are key components. We investigated e-learning as a tool to improve lung transplant recipients' knowledge of post-transplant care such as hygiene, self-monitoring, travel precautions, vaccinations, and the importance of adherence to medication.  Objective:  To compare the effect of e-learning and conventional patient education with respect to level of knowledge and drug adherence. A single-center open randomized controlled trial design was used.  Methods:  Lung transplant recipients were randomized to an e-learning program or standard care. One month before a scheduled follow-up visit, the intervention group received a link by e-mail to a 15-min e-learning program. At the follow-up visit, all lung transplant recipients completed two drug adherence questionnaires (Basel Assessment of Adherence with Immunosuppressive medication Scales [BAASIS] and Transplant Adherence Questionnaire [TAQ]) and a questionnaire testing their knowledge of post-transplant care.  Results:  Fifty lung transplant recipients were randomized with 24 recipients in each group completing the study. Recipient adherence measured by BAASIS showed a tendency toward improved drug adherence in the intervention group compared with the control group (71% vs. 55%, p  = 0.23). TAQ showed no difference between the two groups ( p  = 1.0). Recipients in the intervention group had a significantly higher number of correct answers to questions about transplant-friendly lifestyle (median 11 vs. 10,  p  = 0.02).   Conclusion:  A 15-min e-learning program is a simple and effective tool to improve lung transplant recipients' knowledge of post-transplant care.",2020,A 15-min e-learning program is a simple and effective tool to improve lung transplant recipients' knowledge of post-transplant care.,"[""lung transplant recipients' knowledge of post-transplant care"", 'Patients', 'Fifty lung transplant recipients', 'lung transplant recipients', 'Lung transplant recipients']","['immunosuppressive medicine', 'e-learning and conventional patient education', 'e-learning program or standard care', 'link by e-mail to a 15-min e-learning program', 'TAQ']","['drug adherence questionnaires (Basel Assessment of Adherence with Immunosuppressive medication Scales [BAASIS] and Transplant Adherence Questionnaire [TAQ]) and a questionnaire testing their knowledge of post-transplant care', 'drug adherence', 'number of correct answers to questions about transplant-friendly lifestyle', 'Recipient adherence']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0086858', 'cui_str': 'Programmed Learning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",,0.0335534,A 15-min e-learning program is a simple and effective tool to improve lung transplant recipients' knowledge of post-transplant care.,"[{'ForeName': 'Tina Beck', 'Initials': 'TB', 'LastName': 'Guldager', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Arhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hyldgaard', 'Affiliation': 'Diagnostic Centre, University Research Clinic for innovative Patient Pathways, Silkeborg Regional Hospital, Midtjylland, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hilberg', 'Affiliation': 'Department of Internal Medicine, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Arhus University Hospital, Aarhus N, Denmark.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0101']
3176,33035186,Neutral douche: a hydrotherapeutic tool to manage pain and systemic symptoms in primary dysmenorrhea - a randomised controlled study.,"Background & Objectives The douche, one of the hydrotherapeutic treatment modality is commonly used by Naturopathy physicians as a treatment of choice in the management of several ailments. This study was done to assess the effect of full body neutral douche in the management of pain and systemic symptoms in adult females with primary dysmenorrhoea. Methods 68 subjects of age 18-22 years with primary dysmenorrhoea were recruited for the study and were randomly divided into two groups: the experimental group (n = 34) and the control group (n = 34). The experimental group received whole body neutral douche, whereas the control group followed the routine as usual. Assessments for the pain, systemic symptoms and menstrual cramps were done by using McGill Pain Questionnaire, Verbal multidimensional scoring system and analog scale for severity of pain and menstrual cramps respectively at baseline, day 30 and day 60 of intervention. Two- way repeated measures of ANOVA was performed to understand the between group changes, adjusted for the respective baseline values and age. Result Data was analyzed with SPSS (Version 21.0) package. Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?2 = 0.771], severity of pain [F(2,66) = 70.418, p < 0.0005, partial ?2 = 0.681], cramps [F(2,66) = 75.986, p < 0.0005, partial ?2 = 0.697] and systemic symptoms [F(2,66) = 14.64, p < 0.0005, partial ?2 = 0.307] as compared to the control group. Conclusion Findings suggest that neutral douche can be used as a non-pharmacological intervention in the management of pain and systemic symptoms in primary dysmenorrhea.",2020,"Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?","['adult females with primary dysmenorrhoea', '68 subjects of age 18-22 years with primary dysmenorrhoea', 'primary dysmenorrhea ']",['hydrotherapeutic tool'],"['pain and systemic symptoms', 'McGill Pain Questionnaire, Verbal multidimensional scoring system and analog scale for severity of pain and menstrual cramps', 'systemic symptoms', 'pain, systemic symptoms and menstrual cramps']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",68.0,0.0584242,"Neutral douche resulted in significant improvement in pain [F(2,66) = 114.564, p < 0.0005, partial ?","[{'ForeName': 'Sataz', 'Initials': 'S', 'LastName': 'Rahmania', 'Affiliation': ""Alva's College of Naturopathy and Yogic Sciences, Moodbidri, India.""}, {'ForeName': 'Vanitha', 'Initials': 'V', 'LastName': 'Shetty', 'Affiliation': ""Alva's College of Naturopathy and Yogic Sciences, Moodbidri, India.""}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ragavendrasamy', 'Affiliation': 'Government Hospital, Udumalpet, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0241']
3177,33035194,A proof-of-concept study on the impact of a chronic pain and physical activity training workshop for exercise professionals.,"Objectives Physical activity is essential for long-term chronic pain management, yet individuals struggle to participate. Exercise professionals, including fitness instructors, and personal trainers, are preferred delivery agents for education and instruction on chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills. However, exercise professionals receive no relevant training during certification or continuing education opportunities to effectively support their participants living with chronic pain. Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted. The purpose was to examine the impacts of a newly developed chronic pain and physical activity training workshop on psychosocial outcomes among exercise professionals. Outcomes included knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain. Methods Forty-eight exercise professionals (Mage=44.4±11.0 years) participated in a three-hour, in-person workshop that was offered at one of four different locations. Participants completed pre- and post-workshop outcome assessment surveys. Results Mixed MANOVA results comparing time (pre- versus post-workshop) by workshop location (sites 1 to 4) illustrated a significant within-subjects time effect (p<0.001). All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59). Conclusions Findings offer early phase preliminary support for the effectiveness of the chronic pain and physical activity training workshop for exercise professionals. Based on ORBIT model recommendations, findings warrant future phased testing via a pilot randomized clinical trial as well as testing for impacts that trained professionals have on activity adherence among their clients living with chronic pain. Eventual workshop adoption by exercise professional certification organizations would ensure widespread and sustainable access to qualified exercise professionals to help individuals engage in physical activity. By increasing the capacity of available exercise professionals to deliver effective support, active individuals could better manage their chronic pain and live well.",2020,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","['participants living with chronic pain', 'clients living with chronic pain']","['physical activity training workshop', 'exercise professionals receive no relevant training during certification or continuing education opportunities']","['knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain', 'chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",48.0,0.0595817,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","[{'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Gyurcsik', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Tupper', 'Affiliation': 'Pain Quality Improvement and Research for the Saskatchewan Health Authority, Saskatoon, SK, Canada.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Brittain', 'Affiliation': 'University of Northern Colorado, College of Natural and Health Sciences, Greeley, CO, USA.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Miranda A', 'Initials': 'MA', 'LastName': 'Cary', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Ratcliffe-Smith', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}, {'ForeName': 'Jocelyn E', 'Initials': 'JE', 'LastName': 'Blouin', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}, {'ForeName': 'Mackenzie G', 'Initials': 'MG', 'LastName': 'Marchant', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sessford', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Laurie-Ann M', 'Initials': 'LM', 'LastName': 'Hellsten', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Arnold', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Downe', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0089']
3178,33035202,Comparison Between Percutaneous Transforaminal Endoscopic Discectomy and Fenestration in the Treatment of Degenerative Lumbar Spinal Stenosis.,"BACKGROUND This study aimed to investigate the therapeutic and prognostic effects of percutaneous transforaminal endoscopic decompression (PTED) for degenerative lumbar spinal stenosis (DLSS). MATERIAL AND METHODS One hundred eighty-eight patients with DLSS were randomly divided into the fenestration and the PTED group for decompression treatment. Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications in the 2 groups were compared. All patients underwent computed tomography (CT) scanning and magnetic resonance imaging (MRI) on the first postoperative day. All patients were assessed preoperatively and the treatment effects at 3, 6, and 12 months postoperatively were evaluated using visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI). The modified MacNab criteria were used to assess patient satisfaction 1 year after surgery at the last follow-up. RESULTS Patients who underwent PTED had shorter incisions, less blood loss, and shorter hospital stays than those in the fenestration group, but operative times and complication rates were similar in the 2 groups. Moreover, CT scanning and MRI revealed similar treatment effects in the 2 groups. Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups. In particular, all 3 scores in the PTED group were higher than those in the fenestration group at 3 and 6 months postoperatively. There were no significant differences in MacNab scores between the 2 groups. CONCLUSIONS PTED is safer and more effective than traditional fenestration for management of DLSS.",2020,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","['Degenerative Lumbar Spinal Stenosis', 'One hundred eighty-eight patients with DLSS', 'degenerative lumbar spinal stenosis (DLSS']","['computed tomography (CT) scanning and magnetic resonance imaging (MRI', 'percutaneous transforaminal endoscopic decompression (PTED', 'Percutaneous Transforaminal Endoscopic Discectomy and Fenestration']","['VAS, ODI, and JOA scores', 'operative times and complication rates', 'visual analog scale (VAS), Japanese Orthopedic Association Score (JOA) and Oswestry Disability Index (ODI', 'MacNab scores', 'Operative time, incision length, amount of blood loss, length of hospitalization, and rates of complications', 'blood loss, and shorter hospital stays']","[{'cui': 'C0410636', 'cui_str': 'Degenerative lumbar spinal stenosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",188.0,0.0207879,"Compared with preoperative status, improvements in VAS, ODI, and JOA scores occurred at different times after surgery in the 2 groups.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Hengjie', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}, {'ForeName': 'Chengcun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Bone Surgery, Yangzhou Hongquan Hospital, Yangzhou, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926631']
3179,33035206,Impact of providing free HIV self-testing kits on frequency of testing among men who have sex with men and their sexual partners in China: A randomized controlled trial.,"BACKGROUND


The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners.
METHODS AND FINDINGS


This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners.
CONCLUSIONS


In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1800015584.",2020,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","['3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive', 'Chinese MSM and their sexual partners', 'men who have sex with men and their sexual partners in China', '4 cities in Hunan Province, China', 'men who have sex with men (MSM) in China', 'Between April 14, 2018, and June 30, 2018, 230 MSM were recruited', 'Sexually active and HIV-negative MSM', 'Mean age was 29 years; 77% attended college; 75% were single']","['free HIV self-testing kits', '2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT', 'HIV self-testing (HIVST) interventions']","['frequency of HIV testing', 'number of HIV tests', 'HIVST', 'number of HIV tests taken by their sexual partners', 'adverse events', 'access to site-based HIV testing (SBHT', 'average frequency of SBHT', 'average frequency of HIV tests', 'likelihood of taking HIV testing']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",230.0,0.169548,"The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055).","[{'ForeName': 'Ci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Koniak-Griffin', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Han-Zhu', 'Initials': 'HZ', 'LastName': 'Qian', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Lloyd A', 'Initials': 'LA', 'LastName': 'Goldsamt', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, New York, United States of America.'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}, {'ForeName': 'Mary-Lynn', 'Initials': 'ML', 'LastName': 'Brecht', 'Affiliation': 'School of Nursing, University of California at Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Xiangya School of Nursing, Central South University, Changsha, Hunan Province, China.'}]",PLoS medicine,['10.1371/journal.pmed.1003365']
3180,33035228,Influence of COVID-19 confinement on students' performance in higher education.,"This study analyzes the effects of COVID-19 confinement on the autonomous learning performance of students in higher education. Using a field experiment with 458 students from three different subjects at Universidad Autónoma de Madrid (Spain), we study the differences in assessments by dividing students into two groups. The first group (control) corresponds to academic years 2017/2018 and 2018/2019. The second group (experimental) corresponds to students from 2019/2020, which is the group of students that had their face-to-face activities interrupted because of the confinement. The results show that there is a significant positive effect of the COVID-19 confinement on students' performance. This effect is also significant in activities that did not change their format when performed after the confinement. We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload. Additionally, an analysis of students' learning strategies before confinement shows that students did not study on a continuous basis. Based on these results, we conclude that COVID-19 confinement changed students' learning strategies to a more continuous habit, improving their efficiency. For these reasons, better scores in students' assessment are expected due to COVID-19 confinement that can be explained by an improvement in their learning performance.",2020,We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload.,"['students in higher education', ""students' performance in higher education"", '458 students from three different subjects at Universidad Autónoma de Madrid (Spain']",['COVID-19 confinement'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0578816', 'cui_str': 'In higher education'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],458.0,0.0202627,We find that this effect is significant both in subjects that increased the number of assessment activities and subjects that did not change the student workload.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gonzalez', 'Affiliation': 'Biochemistry Department, Faculty of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'de la Rubia', 'Affiliation': 'Chemical Engineering Department, Faculty of Sciences, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Hincz', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Comas-Lopez', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Subirats', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Santi', 'Initials': 'S', 'LastName': 'Fort', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Sacha', 'Affiliation': 'Escuela Politécnica Superior, Universidad Autónoma de Madrid, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0239490']
3181,33035274,"Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.","BACKGROUND


Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.
METHODS


Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).
RESULTS


Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.
DISCUSSION


At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.",2020,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","['Four government hospitals', 'Kenyan infant', 'All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age', '626 enrolled infants, 309 (49.4%) received', '198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing']","['GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing', 'delayed POC testing']","['Machine error rates', 'maternal notification', 'repeat POC testing', 'repeat POC testing, defined as testing both at birth and 6-weeks of age', 'Mean time', 'POC testing', 'repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities']","[{'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0722638', 'cui_str': 'Pima brand of potassium iodide'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",626.0,0.0931997,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wexler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Preventive Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Maloba', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Children's Mercy Kansas City, Health Services and Outcomes Research, Kansas City, MO, United States of America.""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Gautney', 'Affiliation': 'Global Health Innovations, Dallas, TX, United States of America.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Maosa', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Shadrack', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Muchoki', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Natabhona', 'Initials': 'N', 'LastName': 'Mabachi', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Lwembe', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}]",PloS one,['10.1371/journal.pone.0240621']
3182,33035340,"Sleep after learning aids the consolidation of factual knowledge, but not relearning.","STUDY OBJECTIVES


Sleep strengthens and reorganizes declarative memories, but the extent to which these processes benefit subsequent relearning of the same material remains unknown. It is also unclear whether sleep-memory effects translate to educationally realistic learning tasks and improve long-term learning outcomes.
METHODS


Young adults learned factual knowledge in two learning sessions that were 12 hours apart and separated by either nocturnal sleep (n=26) or daytime wakefulness (n=26). Memory before and after the retention interval was compared to assess the effect of sleep on consolidation, while memory before and after the second learning session was compared to assess relearning. A final test one week later assessed whether there was any long-term advantage to sleeping between two study sessions.
RESULTS


Sleep significantly enhanced consolidation of factual knowledge (p=0.01, d=0.72), but groups did not differ in their capacity to relearn the materials (p=0.72, d=0.10). After one week, a numerical memory advantage remained for the sleep group but was no longer significant (p=0.21, d=0.35).
CONCLUSIONS


Reduced forgetting after sleep is a robust finding that extends to our ecologically valid learning task, but we found no evidence that sleep enhances relearning. Our findings can exclude a large effect of sleep on long-term memory after one week, but hint at a smaller effect, leaving open the possibility of practical benefits from organizing study sessions around nocturnal sleep. These findings highlight the importance of revisiting key sleep-memory effects to assess their relevance to long-term learning outcomes with naturalistic learning materials.",2020,"RESULTS


Sleep significantly enhanced consolidation of factual knowledge (p=0.01, d=0.72), but groups did not differ in their capacity to relearn the materials (p=0.72, d=0.10).",['Young adults learned factual knowledge in two learning sessions that were 12 hours apart and separated by either nocturnal sleep (n=26) or daytime wakefulness (n=26'],[],"['numerical memory advantage', 'consolidation of factual knowledge']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0180301,"RESULTS


Sleep significantly enhanced consolidation of factual knowledge (p=0.01, d=0.72), but groups did not differ in their capacity to relearn the materials (p=0.72, d=0.10).","[{'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cousins', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Teck Boon', 'Initials': 'TB', 'LastName': 'Teo', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Zhi Yi', 'Initials': 'ZY', 'LastName': 'Tan', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Kian F', 'Initials': 'KF', 'LastName': 'Wong', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Cognitive Neuroscience, Duke-NUS Medical School, Singapore.'}]",Sleep,['10.1093/sleep/zsaa210']
3183,33032657,Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study.,"BACKGROUND


Selective serotonergic reuptake inhibitors (SSRIs) are first-line pharmacologic treatments for patients with posttraumatic stress disorder (PTSD), but must be given over extended period of time before the onset of action. The use of SSRIs in PTSD patients with mild traumatic brain injury (mTBI) is problematic since SSRIs could exacerbate post-concussion syndrome (PCS) symptoms. VA/DOD guidelines identify trauma-focused psychotherapy as the best evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement and retention. A previous study from this research group suggested that quetiapine monotherapy, but not risperidone or valproate, could increase engagement in trauma-focused psychotherapy.
METHODS


We report the study protocol of a pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs. This randomized, open-label study was designed to evaluate the feasibility of completing a randomized trial of quetiapine vs. treatment as usual to promote patient engagement in PTSD patients with a history of mTBI.
DISCUSSION


We expect that the success of this ongoing study should provide us with the preliminary data necessary to design a full-scale randomized trial. Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
TRIAL REGISTRATION


NCT04280965 .",2020,"Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
","['PTSD patients with a history of mTBI', 'pilot study funded under the South-Central Mental Illness Research, Education, and Clinical Center pilot study program from the U.S. Department of Veterans Affairs', 'PTSD patients with mild traumatic brain injury (mTBI', 'patients with posttraumatic stress disorder (PTSD', 'veterans with PTSD and a history of mild traumatic brain injury']","['Quetiapine', 'serotonergic reuptake inhibitors (SSRIs', 'quetiapine monotherapy', 'quetiapine', 'SSRIs', 'risperidone or valproate']",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]",[],,0.0674027,"Positive efficacy results in a full- scale trial should inform new VA guidelines for clinical practice by showing that quetiapine-related improvements in patient engagement and retention may be the most effective approach to assure that VA resources achieve the best possible outcome for veterans.
","[{'ForeName': 'Muhammad R', 'Initials': 'MR', 'LastName': 'Baig', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA. Muhammad.baig@va.gov.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Beck', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wilson', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Lemmer', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Meraj', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Meyer', 'Affiliation': 'Department of Veterans Affairs VISN 17 Center of Excellence for Research on Returning War Veterans, Waco, TX, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Mental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Military Medical Research,['10.1186/s40779-020-00278-0']
3184,33032661,"The TIRS trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce Aedes-borne viral illnesses in Merida, Mexico.","BACKGROUND


Current urban vector control strategies have failed to contain dengue epidemics and to prevent the global expansion of Aedes-borne viruses (ABVs: dengue, chikungunya, Zika). Part of the challenge in sustaining effective ABV control emerges from the paucity of evidence regarding the epidemiological impact of any Aedes control method. A strategy for which there is limited epidemiological evidence is targeted indoor residual spraying (TIRS). TIRS is a modification of classic malaria indoor residual spraying that accounts for Aedes aegypti resting behavior by applying residual insecticides on exposed lower sections of walls (< 1.5 m), under furniture, and on dark surfaces.
METHODS/DESIGN


We are pursuing a two-arm, parallel, unblinded, cluster randomized controlled trial to quantify the overall efficacy of TIRS in reducing the burden of laboratory-confirmed ABV clinical disease (primary endpoint). The trial will be conducted in the city of Merida, Yucatan State, Mexico (population ~ 1million), where we will prospectively follow 4600 children aged 2-15 years at enrollment, distributed in 50 clusters of 5 × 5 city blocks each. Clusters will be randomly allocated (n = 25 per arm) using covariate-constrained randomization. A ""fried egg"" design will be followed, in which all blocks of the 5 × 5 cluster receive the intervention, but all sampling to evaluate the epidemiological and entomological endpoints will occur in the ""yolk,"" the center 3 × 3 city blocks of each cluster. TIRS will be implemented as a preventive application (~ 1-2 months prior to the beginning of the ABV season). Active monitoring for symptomatic ABV illness will occur through weekly household visits and enhanced surveillance. Annual sero-surveys will be performed after each transmission season and entomological evaluations of Ae. aegypti indoor abundance and ABV infection rates monthly during the period of active surveillance. Epidemiological and entomological evaluation will continue for up to three transmission seasons.
DISCUSSION


The findings from this study will provide robust epidemiological evidence of the efficacy of TIRS in reducing ABV illness and infection. If efficacious, TIRS could drive a paradigm shift in Aedes control by considering Ae. aegypti behavior to guide residual insecticide applications and changing deployment to preemptive control (rather than in response to symptomatic cases), two major enhancements to existing practice.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04343521 . Registered on 13 April 2020. The protocol also complies with the WHO International Clinical Trials Registry Platform (ICTRP) (Additional file 1).
PRIMARY SPONSOR


National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID).",2020,"TIRS is a modification of classic malaria indoor residual spraying that accounts for Aedes aegypti resting behavior by applying residual insecticides on exposed lower sections of walls (< 1.5 m), under furniture, and on dark surfaces.
","['Merida, Mexico', '4600 children aged 2-15\u2009years at enrollment, distributed in 50 clusters of 5\u2009×\u20095 city blocks each', 'city of Merida, Yucatan State, Mexico (population ~\u20091million']","['TIRS', 'preventive targeted indoor residual spraying']",['aegypti indoor abundance and ABV infection rates'],"[{'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1269265', 'cui_str': 'Yucatan Miniature pig'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]","[{'cui': 'C0078137', 'cui_str': 'VBA protocol'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",4600.0,0.136498,"TIRS is a modification of classic malaria indoor residual spraying that accounts for Aedes aegypti resting behavior by applying residual insecticides on exposed lower sections of walls (< 1.5 m), under furniture, and on dark surfaces.
","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Manrique-Saide', 'Affiliation': 'Unidad Colaborativa de Bioensayos Entomológicos, Campus de Ciencias Biológicas y Agropecuarias, Universidad Autónoma de Yucatán, Merida, Mexico.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Dean', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Center for Inference and Dynamics of Infectious Diseases, Seattle, WA, 98109, USA.'}, {'ForeName': 'Ira M', 'Initials': 'IM', 'LastName': 'Longini', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, Decatur, GA, 30030, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Waller', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Gomez-Dantes', 'Affiliation': 'Health Systems Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hladish', 'Affiliation': 'Emerging Pathogens Institute, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Azael', 'Initials': 'A', 'LastName': 'Che-Mendoza', 'Affiliation': 'Unidad Colaborativa de Bioensayos Entomológicos, Campus de Ciencias Biológicas y Agropecuarias, Universidad Autónoma de Yucatán, Merida, Mexico.'}, {'ForeName': 'Oscar D', 'Initials': 'OD', 'LastName': 'Kirstein', 'Affiliation': 'Department of Environmental Sciences, Math and Science Center, Emory University, 400 Dowman Drive, 5th floor, Suite E530, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Yamila', 'Initials': 'Y', 'LastName': 'Romer', 'Affiliation': 'Department of Environmental Sciences, Math and Science Center, Emory University, 400 Dowman Drive, 5th floor, Suite E530, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Correa-Morales', 'Affiliation': 'Centro Nacional de Programas Preventivos y Control de Enfermedades (CENAPRECE) Secretaría de Salud Mexico, Mexico City, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacio-Vargas', 'Affiliation': 'Secretaria de Salud de Yucatan, Merida, Yucatan, Mexico.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Mendez-Vales', 'Affiliation': 'Secretaria de Salud de Yucatan, Merida, Yucatan, Mexico.'}, {'ForeName': 'Pilar Granja', 'Initials': 'PG', 'LastName': 'Pérez', 'Affiliation': 'Secretaria de Salud de Yucatan, Merida, Yucatan, Mexico.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Pavia-Ruz', 'Affiliation': 'Centro de Investigaciones Regionales Hideyo Noguchi, Universidad Autonoma de Yucatan, Merida, Mexico.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Ayora-Talavera', 'Affiliation': 'Centro de Investigaciones Regionales Hideyo Noguchi, Universidad Autonoma de Yucatan, Merida, Mexico.'}, {'ForeName': 'Gonzalo M', 'Initials': 'GM', 'LastName': 'Vazquez-Prokopec', 'Affiliation': 'Department of Environmental Sciences, Math and Science Center, Emory University, 400 Dowman Drive, 5th floor, Suite E530, Atlanta, GA, 30322, USA. gmvazqu@emory.edu.'}]",Trials,['10.1186/s13063-020-04780-7']
3185,33032686,Postinflammatory Hyperpigmentation following Electrodesiccation with a Eutectic Mixture of Local Anesthetics.,"We assessed the effects of prior application of a eutectic mixture of local anesthetics (EMLA) on the appearance of dyschromia at the site of superficial electrodesiccation in an observer-blind, case-control study in 60 patients. Thirty subjects each were assigned to Groups A and B; both groups underwent radiofrequency (RFC) ablation for facial dermatosis papulosa nigrans (DPN). Group A received RFC ablation with prior application of EMLA, whereas Group B did not. No significant difference was observed in the dyschromia between both groups. EMLA cream was well tolerated by the study participants. ( SKINmed . 2020;18:222-225).",2020,No significant difference was observed in the dyschromia between both groups.,"['60 patients', 'Thirty subjects']","['radiofrequency (RFC) ablation for facial dermatosis papulosa nigrans (DPN', 'Electrodesiccation with a Eutectic Mixture of Local Anesthetics', 'EMLA cream', 'RFC ablation with prior application of EMLA', 'eutectic mixture of local anesthetics (EMLA']",['dyschromia'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0015456', 'cui_str': 'Facial Dermatosis'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0185056', 'cui_str': 'Electrodesiccation'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}]",60.0,0.0144264,No significant difference was observed in the dyschromia between both groups.,"[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Nagar', 'Affiliation': 'Department of Dermatology, Mahatma Gandhi Medical College & Maharaja Yashwantrao Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Department of Dermatology, Mahatma Gandhi Medical College & Maharaja Yashwantrao Hospital, Indore, Madhya Pradesh, India; sdubey17@gmail.com.'}, {'ForeName': 'Danish', 'Initials': 'D', 'LastName': 'Anwar', 'Affiliation': 'Department of Dermatology, Mahatma Gandhi Medical College & Maharaja Yashwantrao Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Dermatology, Mahatma Gandhi Medical College & Maharaja Yashwantrao Hospital, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Khare', 'Affiliation': 'Department of Dermatology, Mahatma Gandhi Medical College & Maharaja Yashwantrao Hospital, Indore, Madhya Pradesh, India.'}]",Skinmed,[]
3186,33032710,Effect of Ticagrelor on Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI).,"OBJECTIVES


The aim of this study was to evaluate the effect of ticagrelor versus clopidogrel on left ventricular (LV) remodeling after reperfusion of ST-segment elevation myocardial infarction (STEMI) in humans.
BACKGROUND


Animal studies have demonstrated that ticagrelor compared with clopidogrel better protects myocardium against reperfusion injury and improves remodeling after myocardial infarction.
METHODS


In this investigator-initiated, randomized, open-label, assessor-blinded trial performed at 10 centers in Korea, patients were enrolled if they had naive STEMI successfully treated with primary percutaneous coronary intervention (PCI) and at least 6-month planned duration of dual-antiplatelet treatment. The coprimary endpoints were LV remodeling index (LVRI) (a relative change of LV end-diastolic volume) measured on 3-dimensional echocardiography and N-terminal pro-B-type natriuretic peptide level at 6 months.
RESULTS


Among initially enrolled patients with STEMI (n = 336), 139 in each group completed the study. LVRI at 6 months was numerically lower with ticagrelor versus clopidogrel (0.6 ± 18.6% vs. 4.5 ± 16.5%; p = 0.095). Ticagrelor significantly reduced the 6-month level of N-terminal pro-B-type natriuretic peptide (173 ± 141 pg/ml vs. 289 ± 585 pg/ml; p = 0.028). These differences were prominent in patients with pre-PCI TIMI (Thrombolysis In Myocardial Infarction) flow grade 0. By multivariate analysis, ticagrelor versus clopidogrel reduced the risk for positive LV remodeling (LVRI >0%) (odds ratio: 0.56; 95% confidence interval: 0.33 to 0.95; p = 0.030). The LV end-diastolic volume index remained unchanged during ticagrelor treatment (from 54.7 ± 12.2 to 54.2 ± 12.2 ml/m 2 ; p = 0.629), but this value increased over time during clopidogrel treatment (from 54.6 ± 11.3 to 56.4 ± 13.9 ml/m 2 ; p = 0.056) (difference -2.3 ml/m 2 ; 95% confidence interval: -4.8 to 0.2 ml/m 2 ; p = 0.073). Ticagrelor reduced LV end-systolic volume index (from 27.0 ± 8.5 to 24.7 ± 8.4 ml/m 2 ; p < 0.001), whereas no reduction was seen with clopidogrel (from 26.2 ± 8.9 to 25.6 ± 11.0 ml/m 2 ; p = 0.366) (difference -1.8 ml/m 2 ; 95% confidence interval: -3.5 to -0.1 ml/m 2 ; p = 0.040).
CONCLUSIONS


Ticagrelor was superior to clopidogrel for LV remodeling after reperfusion of STEMI with primary PCI. (High Platelet Inhibition With Ticagrelor to Improve Left Ventricular Remodeling in Patients With ST Segment Elevation Myocardial Infarction [HEALING-AMI]; NCT02224534).",2020,Ticagrelor significantly reduced the 6-month level of N-terminal pro-B-type natriuretic peptide (173 ± 141 pg/ml vs. 289 ± 585 pg/ml; p = 0.028).,"['patients with pre-PCI TIMI', 'humans', 'Patients With ST Segment Elevation Myocardial Infarction', 'initially enrolled patients with STEMI (n\xa0=\xa0336), 139 in each group completed the study', 'Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI', '10 centers in Korea, patients were enrolled if they had naive STEMI successfully treated with primary percutaneous coronary intervention (PCI) and at least 6-month planned duration of dual-antiplatelet treatment']","['Ticagrelor', 'clopidogrel', 'ticagrelor versus clopidogrel', 'ticagrelor']","['Left Ventricular Remodeling', 'risk for positive LV remodeling', 'LV end-systolic volume index', 'LVRI', 'LV end-diastolic volume index', 'LV remodeling index (LVRI) (a relative change of LV end-diastolic volume) measured on 3-dimensional echocardiography and N-terminal pro-B-type natriuretic peptide level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end-diastolic cavity size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.176249,Ticagrelor significantly reduced the 6-month level of N-terminal pro-B-type natriuretic peptide (173 ± 141 pg/ml vs. 289 ± 585 pg/ml; p = 0.028).,"[{'ForeName': 'Yongwhi', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Jin Sin', 'Initials': 'JS', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Jae-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Jae-Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan Medical Center, Ulsan Hospital, Ulsan, South Korea.'}, {'ForeName': 'Ju Hyeon', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.'}, {'ForeName': 'Woojung', 'Initials': 'W', 'LastName': 'Chun', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.'}, {'ForeName': 'Sang Yeub', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Jang-Whan', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Jeong Su', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.'}, {'ForeName': 'Weon', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Department of Internal Medicine, Kyung Hee University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Mark Y', 'Initials': 'MY', 'LastName': 'Chan', 'Affiliation': 'Singapore National University Heart Center, Singapore National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Min Gyu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Hyun-Woong', 'Initials': 'HW', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Jin-Yong', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Jong-Hwa', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Daejeon, South Korea. Electronic address: siwanc@cnu.ac.kr.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Changwon Hospital, Changwon, South Korea. Electronic address: goodoctor@naver.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.08.007']
3187,33032778,"Economic Evaluation of Factorial Trials: Cost-Utility Analysis of the Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes 2 × 2 × 2 Factorial Trial of Atorvastatin, Omega-3 Fish Oil, and Action Planning.","OBJECTIVES


We applied principles for conducting economic evaluations of factorial trials to a trial-based economic evaluation of a cluster-randomized 2 × 2 × 2 factorial trial. We assessed the cost-effectiveness of atorvastatin, omega-3 fish oil, and an action-planning leaflet, alone and in combination, from a UK National Health Service perspective.
METHODS


The Atorvastatin in Factorial With Omega EE90 Risk Reduction in Diabetes (AFORRD) Trial randomized 800 patients with type 2 diabetes to atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care. The trial was conducted at 59 UK general practices. Sixteen-week outcomes for each trial participant were extrapolated for 70 years using the United Kingdom Prospective Diabetes Study Outcomes Model v2.01. We analyzed the trial as a 2 × 2 factorial trial (ignoring interactions between action-planning leaflet and medication), as a 2 × 2 × 2 factorial trial (considering all interactions), and ignoring all interactions.
RESULTS


We observed several qualitative interactions for costs and quality-adjusted life-years (QALYs) that changed treatment rankings. However, different approaches to analyzing the factorial design did not change the conclusions. There was a ≥99% chance that atorvastatin is cost-effective and omega-3 is not, at a £20 000/QALY threshold.
CONCLUSIONS


Atorvastatin monotherapy was the most cost-effective combination of the 3 trial interventions at a £20 000/QALY threshold. Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning. Recently-developed methods for analyzing factorial trials and combining parameter and sampling uncertainty were extended to estimate cost-effectiveness acceptability curves within a 2x2x2 factorial design with model-based extrapolation.",2020,"Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning.","['59 UK general practices', 'Diabetes', '800 patients with type 2 diabetes to']","['Omega-3 fish oil', 'atorvastatin, omega-3 fish oil', 'Atorvastatin', 'atorvastatin', 'Atorvastatin, Omega-3 Fish Oil, and Action Planning', 'Atorvastatin monotherapy', 'atorvastatin, omega-3, or their respective placebos and randomized general practices to receive a leaflet-based action-planning intervention designed to improve compliance or standard care']",[],"[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",[],800.0,0.0510697,"Omega-3 fish oil was not cost-effective, while there was insufficient evidence to draw firm conclusions about action planning.","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, England, UK. Electronic address: helen.dakin@ndph.ox.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, England, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.05.018']
3188,33032795,The effects of a self-regulation programme on self-care behaviour in patients with heart failure: A randomized controlled trial.,"BACKGROUND


Self-care behaviour is important for patients with heart failure to prevent disease progression. More than half of patients have poor self-care behaviour. Self-regulation theory emphasizes that patients need to initiate monitoring of their symptoms, identify their own problems, and perform appropriate self-care behaviour. However, studies focused on interventions based on self-regulation theory for patients with heart failure are limited.
OBJECTIVES


To investigate the effects of a self-regulation programme on self-care behaviour in patients with heart failure.
DESIGN


A randomized controlled trial.
PARTICIPANTS AND SETTING


Eighty-two patients with heart failure were recruited from a cardiovascular outpatient department at a teaching hospital in northern Taiwan.
METHODS


Participants were randomly assigned to the intervention (n = 41) or control group (n = 41). The intervention group participated in a 4-week self-regulation programme, including one 20-to-30-min, face-to-face individual self-regulation education session and 15- to 20-min telephone follow-up counselling sessions twice per week for four weeks. The control group received only routine outpatient care. Self-care behaviour was measured by the Self-Care of Heart Failure Index at baseline, 4 weeks and 8 weeks after patients were enroled.
RESULTS


The intervention group reported improvements in self-care behaviours, including self-maintenance and self-confidence subscale scores, after four weeks of the self-regulation programme. In contrast, the control group showed no significant differences. Compared with the control group, the intervention group exhibited significantly greater improvements in self-care maintenance (B = 3.74, p = 0.01), self-care management (B = 6.33, p = 0.004), and self-care confidence (B = 5.15, p = 0.003) at four weeks but showed significantly greater improvements only in self-care management (B = 6.97, p = 0.03) and self-care confidence (B = 6.24, p = 0.001) at 8 weeks.
CONCLUSIONS


This study confirmed that a self-regulation programme could effectively improve self-care behaviour in patients with heart failure. Further studies with multicentre randomized controlled trials and larger populations of heart failure patients are necessary to evaluate the effect of this self-regulation programme in various regions and countries.
TWEETABLE ABSTRACT


A home-based self-regulation programme could effectively improve self-care behaviour in patients with heart failure.",2020,"The intervention group reported improvements in self-care behaviours, including self-maintenance and self-confidence subscale scores, after four weeks of the self-regulation programme.","['heart failure patients', 'Participants', 'Eighty-two patients with heart failure were recruited from a cardiovascular outpatient department at a teaching hospital in northern Taiwan', 'patients with heart failure', 'patients with heart failure to prevent disease progression']","['4-week self-regulation programme, including one 20-to-30-min, face-to-face individual self-regulation education session and 15- to 20-min telephone follow-up counselling sessions', 'self-regulation programme', 'routine outpatient care']","['self-care management', 'self-care confidence', 'Self-care behaviour', 'self-care behaviours, including self-maintenance and self-confidence subscale scores', 'self-care maintenance', 'Self-Care of Heart Failure Index', 'self-care behaviour']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",82.0,0.0390952,"The intervention group reported improvements in self-care behaviours, including self-maintenance and self-confidence subscale scores, after four weeks of the self-regulation programme.","[{'ForeName': 'Ming-Ya', 'Initials': 'MY', 'LastName': 'Hsu', 'Affiliation': 'School of Business, University of California, Riverside, CA, United States.'}, {'ForeName': 'Cheng-Wen', 'Initials': 'CW', 'LastName': 'Chiang', 'Affiliation': 'Division of Cardiology, Cathy General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ai-Fu', 'Initials': 'AF', 'LastName': 'Chiou', 'Affiliation': 'School of Nursing, National Yang-Ming University, No. 155, Sec. 2, Li-Nong St., Taipei, Taiwan. Electronic address: afchiou@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103778']
3189,33032804,[Comparison between subarachnoid morphine and femoral nerve block for analgesia after knee ligament reconstruction: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES


There is no consensus of the ideal technique to provide analgesia in knee ligament reconstructions. The aim of this study was to compare the intensity of postoperative pain in these patients under different modalities of analgesia.
METHOD


Randomized and controlled clinical trial of patients undergoing reconstruction of the anterior cruciate ligament (ACL) with flexor tendons between December 2013 and 2014. All patients underwent spinal anesthesia and rescue analgesia with tramadol. The Groups C, M, R0,375 and R0,25 were compared with only the previously described technique, subarachnoid morphine (100 μg) or femoral nerve block with 25 mL of 0.375% ropivacaine and 0.25%, respectively. Pain intensity at 6, 12 and 24hours, age, sex, rescue analgesia, adverse reactions and satisfaction were evaluated.
RESULTS


Among the 83 eligible patients, a predominance of males (85.7%) was observed, between 28 and 31 years. The Group C requested more opioid (27.3%) than the other groups, without significance when compared. There were no significant differences in pain intensity at 6, 12 and 24hours. There was a higher incidence of urinary retention in the Group M (23.8%) than in the R0,375 (0%) and prolonged quadriceps motor block in the R0,375 Group (30%) than in the M and C Groups (0%), with statistical significance (p < 0.05).
CONCLUSION


There was no difference in the intensity of postoperative pain in patients submitted to anterior cruciate ligament reconstruction with flexor tendons under the analgesic modalities evaluated, despite the predominance of urinary retention in the M Group and motor block in the R0,375 Group.",2020,"There was no difference in the intensity of postoperative pain in patients submitted to anterior cruciate ligament reconstruction with flexor tendons under the analgesic modalities evaluated, despite the predominance of urinary retention in the M Group and motor block in the R0,375 Group.","['patients undergoing reconstruction of the anterior cruciate ligament (ACL) with flexor tendons between December 2013 and 2014', '83\xa0eligible patients, a predominance of males (85.7%) was observed, between 28 and 31 years', 'analgesia after knee ligament reconstruction', 'patients under different modalities of analgesia']","['subarachnoid morphine and femoral nerve block', 'spinal anesthesia and rescue analgesia with tramadol', 'subarachnoid morphine (100\xa0μg) or femoral nerve block with 25\xa0mL of\xa00.375% ropivacaine']","['urinary retention', 'intensity of postoperative pain', 'pain intensity', 'Pain intensity at 6, 12 and 24hours, age, sex, rescue analgesia, adverse reactions and satisfaction', 'prolonged quadriceps motor block', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}]","[{'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.0808838,"There was no difference in the intensity of postoperative pain in patients submitted to anterior cruciate ligament reconstruction with flexor tendons under the analgesic modalities evaluated, despite the predominance of urinary retention in the M Group and motor block in the R0,375 Group.","[{'ForeName': 'Joana Zulian', 'Initials': 'JZ', 'LastName': 'Fiorentin', 'Affiliation': 'Hospital Universitário Cajuru, Serviço de Anestesiologia, Curitiba, PR, Brasil; Hospital Universitário Cajuru, Departamento de Residência Médica, Curitiba, PR, Brasil; Universidade Federal do Paraná (UFPR), Programa de Pós-Graduação em Clínica Cirúrgica, Curitiba, Paraná, Brasil. Electronic address: joanafiorentin@yahoo.com.br.'}, {'ForeName': 'Alexandre Vieira', 'Initials': 'AV', 'LastName': 'Martins', 'Affiliation': 'Hospital Universitário Cajuru, Serviço de Anestesiologia, Curitiba, PR, Brasil; Hospital Universitário Cajuru, Departamento de Residência Médica, Curitiba, PR, Brasil.'}, {'ForeName': 'Juan Manuel Vélez', 'Initials': 'JMV', 'LastName': 'Cañola', 'Affiliation': 'Hospital Universitário Cajuru, Serviço de Anestesiologia, Curitiba, PR, Brasil; Hospital Universitário Cajuru, Departamento de Residência Médica, Curitiba, PR, Brasil.'}, {'ForeName': 'Linda Cecilia', 'Initials': 'LC', 'LastName': 'Gutierrez', 'Affiliation': 'Hospital Universitário Cajuru, Serviço de Anestesiologia, Curitiba, PR, Brasil; Hospital Universitário Cajuru, Departamento de Residência Médica, Curitiba, PR, Brasil.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Perches', 'Affiliation': 'Hospital Universitário Cajuru, Serviço de Anestesiologia, Curitiba, PR, Brasil; Hospital Universitário Cajuru, Departamento de Residência Médica, Curitiba, PR, Brasil.'}, {'ForeName': 'Thiago Mamôru', 'Initials': 'TM', 'LastName': 'Sakae', 'Affiliation': 'Universidade do Sul de Santa Catarina (Unisul), Florianópolis, SC, Brasil.'}, {'ForeName': 'Sérgio Bernardo', 'Initials': 'SB', 'LastName': 'Tenório', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Programa de Pós-Graduação em Clínica Cirúrgica, Curitiba, Paraná, Brasil; Sociedade Brasileira de Anestesiologia, Rio de Janeiro, RJ, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.08.006']
3190,33032806,[Comparison of post-operative nausea and vomiting with intravenous versus inhalational anesthesia in laparotomic abdominal surgery: a randomized clinical trial].,"BACKGROUND


Postoperative Nausea and Vomiting (PONV) is a multifactorial surgical complication with an unclear underlying cause. Anesthetic methods, patients' characteristics and the type of surgery are considered as factors affecting PONV. This study was designed to compare the effect of inhalational and intravenous anesthesia in abdominal surgery on the incidence and severity of PONV.
METHODS


A single-blinded prospective randomized clinical trial on 105 patients aged 18-65 years was carried out. Patients were divided in two groups of Total Intravenous Anesthesia (TIVA) and Inhalational anesthesia. The incidence and severity of PONV were examined at 0, 2, 6, 12, and 24hours after the surgery. The use of a rescue antiemetic was also evaluated.
RESULTS


Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001). The incidence of vomiting was reported in 11.3% of the Inhalational group and 3.8% of the TIVA group (p=0.15), and 24.5% of patients in the Inhalation group and 9.6% of patients in the intravenous group needed an antiemetic medication (p=0.043).
CONCLUSION


The incidence of postoperative nausea and vomiting and the need for administration of an antiemetic rescue drug, and the severity of nausea in patients were significantly lower in the TIVA group.",2020,Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001).,"['105\xa0patients aged 18-65\xa0years', 'laparotomic abdominal surgery']","['inhalational and intravenous anesthesia', 'inhalational anesthesia', 'Total Intravenous Anesthesia (TIVA) and Inhalational anesthesia']","['antiemetic medication', 'postoperative nausea and vomiting', 'PONV', 'incidence and severity of PONV', 'severity of nausea', 'incidence of vomiting']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0806419,Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ahmadzadeh Amiri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomini Hospital Complex, Tehran, Iran.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Karvandian', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of Anesthesiology, Tehran, Iran. Electronic address: karvandian@tums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ashouri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of General Surgery, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of Anesthesiology, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahmadzadeh Amiri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomini Hospital Complex, Tehran, Iran.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.019']
3191,33032824,"Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy.","OBJECTIVE


Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC).
METHODS


The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat.
RESULTS


Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65).
CONCLUSIONS


LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.",2020,"CONCLUSIONS


LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol.","['women aged ≥18 to ≤45\xa0years with screen detected AIS to LEEP or CKC', '40 patients', 'Patients were enrolled at seven hospitals in Australia and New Zealand', 'situ endocervical adenocarcinoma (EXCISE', 'Between August 2, 2017 and September 6, 2019']","['LEEP', 'LEEP or CKC', 'electrosurgical excision procedure and cold knife cone biopsy', ""loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC"", 'CKC']","['grade three complications', 'margin status, specimen size and fragmentation', 'Margin status', 'post-operative complications', 'specimen dimensions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1263762', 'cui_str': 'Endocervical adenocarcinoma'}]","[{'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0195324', 'cui_str': 'Cone biopsy of cervix'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1299482', 'cui_str': 'Specimen size'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",40.0,0.140008,"CONCLUSIONS


LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cohen', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia. Electronic address: paul.cohen@uwa.edu.au.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Leung', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Sydney Medical School, The University of Sydney, New South Wales, Australia; School of Medicine, Western Sydney University, Penrith South, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'van der Griend', 'Affiliation': 'Department of Anatomical Pathology, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Chivers', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Exercise Medicine Research Institute, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Bilic', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bittinger', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Discipline of Obstetrics and Gynaecology, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Codde', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Eva', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand; Department of Gynaecological Oncology, University of Auckland, Auckland, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Farrell', 'Affiliation': 'Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Harker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Unine', 'Initials': 'U', 'LastName': 'Herbst', 'Affiliation': 'Department of Gynaecological Oncology, Westmead Hospital, Sydney, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jeffares', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Loh', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'McNally', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ganendra Raj', 'Initials': 'GR', 'LastName': 'Mohan', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Dept of Gynaecological Oncology, King Edward Memorial Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Tarryn', 'Initials': 'T', 'LastName': 'Nicholson', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Aime', 'Initials': 'A', 'LastName': 'Powell', 'Affiliation': 'Institute for Health Research, University of Notre Dame Australia, Fremantle, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Salfinger', 'Affiliation': 'Dept of Gynaecological Oncology, St John of God Hospital, Subiaco, Western Australia, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simcock', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Christchurch Womens Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Division of Obstetrics and Gynaecology, University of Western Australia, Crawley, Western Australia, Australia; PathWest, King Edward Memorial Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Silvers', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sykes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Univeristy of Otago, Christchurch, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Christchurch Womens Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Pennie', 'Initials': 'P', 'LastName': 'Stoyles', 'Affiliation': 'Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Clinipath Pathology, Osborne Park, Western Australia, Australia.'}, {'ForeName': 'Ai Ling', 'Initials': 'AL', 'LastName': 'Tan', 'Affiliation': ""Dept of Gynaecological Oncology, National Women's Health, Auckland City Hospital, Auckland, New Zealand; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia.""}, {'ForeName': 'C David H', 'Initials': 'CDH', 'LastName': 'Wrede', 'Affiliation': ""Oncology and Dysplasia Unit, The Royal Women's Hospital, Melbourne, Victoria, Australia; Australia New Zealand Gynaecological Oncology Group, Camperdown, New South Wales, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.""}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.053']
3192,33032837,Randomized parallel-group pilot trial (Best foods for your heart) comparing the effects of a Mediterranean Portfolio diet with a low saturated fat diet on HIV dyslipidemia.,"BACKGROUND & AIMS


Mediterranean diets reduce the risk of cardiovascular disease (CVD). However, the effect is unknown in people living with HIV, who have an increased risk potentially due to the additional burdens of infection, inflammation and antiretroviral treatment (ART). We examined the feasibility of a 6-month dietary intervention in adults with HIV dyslipidemia using a sample size adequate to detect differences in LDL-cholesterol.
METHODS


Sixty adults with stable HIV infection on ART and LDL-cholesterol >3 mmol/l were recruited. Participants were randomized (1:1) to receive dietary advice to reduce saturated fat intake to <10% of energy intake (Diet1), or supported to adopt the Mediterranean Portfolio Diet (Diet2) with additional cholesterol-lowering foods (nuts, stanols, soya, oats, beans) for 6 months. Recruitment, retention and intervention fidelity were monitored. Measurements were conducted at baseline, 6 and 12 months. A secondary analysis examined between group differences in CVD risk factors at month 6 adjusted for baseline values and potential confounders.
RESULTS


Rates of recruitment, participation and attrition were 35%, 91%, and 12% respectively. Reported dietary adherence was 68% to Mediterranean foods and 59% to Portfolio components. At 6 months Diet2 participants (n = 29) had a significantly lower LDL-cholesterol (mean difference adjusted for baseline -0.4 mmol/l, 95%CI -0.7 to -0.1, P = 0.01), and systolic blood pressure (-7 mmHg, 95%CI -2 to -12, P = 0.008) compared to those in Diet1 (n = 31). These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 mmHg, 95%CI -9.4 to 2.5, P = 0.2).
CONCLUSION


We showed the feasibility of adopting a Mediterranean Portfolio diet in people living with HIV. Our findings suggest this intervention might equate to short term improvements in diet quality, blood pressure, and LDL-cholesterol. Further definitive evaluations are required to determine if this is a viable strategy to facilitate cardiovascular risk reduction.
CLINICAL TRIAL REGISTRY


ISRCTN32090191 Best Foods For your heart trial.",2020,"These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 ","['adults with HIV dyslipidemia using a sample size adequate to detect differences in LDL-cholesterol', 'Sixty adults with stable HIV infection on ART and LDL-cholesterol', 'people living with HIV']","['Best Foods', 'Mediterranean Portfolio diet', 'dietary intervention', 'dietary advice to reduce saturated fat intake to <10% of energy intake (Diet1), or supported to adopt the Mediterranean Portfolio Diet (Diet2) with additional cholesterol-lowering foods (nuts, stanols, soya, oats, beans', 'Mediterranean Portfolio diet with a low saturated fat diet']","['dietary adherence', 'HIV dyslipidemia', 'systolic blood pressure ', 'LDL-cholesterol', 'CVD risk factors', 'systolic blood pressure', 'risk of cardiovascular disease (CVD', 'Rates of recruitment, participation and attrition', 'Recruitment, retention and intervention fidelity', 'diet quality, blood pressure, and LDL-cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0452298', 'cui_str': 'Low saturated fat diet'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.176734,"These effects were not sustained at 1 year (LDL-cholesterol -0.05 mmol/l, 95%CI -0.33 to 0.23, P = 0.7; systolic blood pressure -3.5 ","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Stradling', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK; Birmingham Heartlands HIV Service, Department of Infection and Immunology, University Hospitals Birmingham NHS Foundation Trust, UK. Electronic address: clare.stradling@gmail.com.'}, {'ForeName': 'G Neil', 'Initials': 'GN', 'LastName': 'Thomas', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Birmingham Heartlands HIV Service, Department of Infection and Immunology, University Hospitals Birmingham NHS Foundation Trust, UK.'}, {'ForeName': 'Shahrad', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': 'Clinical Research Core and Department of Medicine, Weill Cornell Medicine in Qatar and New York, Doha, Qatar.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.038']
3193,33032868,Effects of narrative persuasion in promoting influenza vaccination in Hong Kong: A randomized controlled trial.,"OBJECTIVES


The study examined the effectiveness of narrative persuasion in promoting influenza vaccination in Hong Kong.
METHODS


The study conducted a randomized controlled trial with a sample of 440 Hong Kong adults who were either at high risk or had a high-risk family member. The participants were randomly assigned to watch a narrative video, an informational video, or no message, and were assessed for perceived threats, perceived efficacy, and vaccination intent, and were followed up three months later for actual vaccination.
RESULTS


Experimental conditions produced significant differences on perceived threats of influenza but not on perceived efficacy, vaccination intent, and actual vaccination. When compared to informational messages delivered containing equivalent amount of information, narrative messages were more persuasive in promoting perceptions about influenza, equally effective in enhancing vaccination intention and actual behaviors, and equally ineffective in changing efficacy beliefs. The persuasiveness of narratives in promoting threat perceptions was found to work better for individuals with lower literacy levels.
CONCLUSIONS


Incorporating authentic sociocultural beliefs and experiences in message design can effectively enhance threats perceptions related to influenza.
PRACTICE IMPLICATIONS


Narratives presented in short-video stories could be an effective tool for promoting health threats especially among high-risk individuals with limited health literacy.",2020,"When compared to informational messages delivered containing equivalent amount of information, narrative messages were more persuasive in promoting perceptions about influenza, equally effective in enhancing vaccination intention and actual behaviors, and equally ineffective in changing efficacy beliefs.","['sample of 440 Hong Kong adults who were either at high risk or had a high-risk family member', 'Hong Kong']","['narrative video, an informational video, or no message', 'narrative persuasion']","['efficacy, vaccination intent, and actual vaccination']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031230', 'cui_str': 'Persuasion'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]",,0.0702098,"When compared to informational messages delivered containing equivalent amount of information, narrative messages were more persuasive in promoting perceptions about influenza, equally effective in enhancing vaccination intention and actual behaviors, and equally ineffective in changing efficacy beliefs.","[{'ForeName': 'Li Crystal', 'Initials': 'LC', 'LastName': 'Jiang', 'Affiliation': 'Department of Media and Communication, City University of Hong Kong, Hong Kong SAR, China. Electronic address: crystal.jiang@cityu.edu.hk.'}]",Patient education and counseling,['10.1016/j.pec.2020.09.025']
3194,33032883,Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT).,"BACKGROUND


Corticosteroids are an integral part of immunosuppression following solid organ transplantation, despite their metabolic complications. We conducted a randomized trial to evaluate the efficacy of steroid-free immunosuppression following live donor liver transplantation (LDLT).
METHODS


We randomized 104 patients stratified based on pre-transplant diabetic status to either a steroid-free arm (SF-arm) (Basiliximab + Tacrolimus and Azathioprine,n = 52) or Steroid arm (S-Arm) (Steroid + Tacrolimus + Azathioprine,n = 52). The primary endpoint was the occurrence of metabolic complications (new-onset diabetes after transplant (NODAT), new-onset systemic hypertension after transplant (NOSHT), post-transplant dyslipidemia) within 6 months after transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR) within six months, patient and graft survival at 6 months.
RESULTS


The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006). Likewise, the incidence of NOSHT (27.8% vs. 4.8%,p-0.01) and hypertriglyceridemia (26.7% vs. 8%,p-0.03) at six months was significantly higher in S-arm. However, there were no differences in BPAR (19.2% vs. 21.2%, p-0.81), time to first rejection (58 vs. 53 days, p-0.78), patient and graft survival (610 vs. 554 days,p- 0.22).
CONCLUSION


Following LDLT, basiliximab induction with tacrolimus and azathioprine maintenance resulted in significantly lower metabolic complications compared to the triple-drug regimen of steroid, tacrolimus, and azathioprine.",2020,"The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006).","['104 patients stratified based on pre-transplant diabetic status to either a', 'live donor liver transplantation (LDLT', 'adult live donor liver transplantation (LDLT']","['Steroid\xa0+\xa0Tacrolimus\xa0+\xa0Azathioprine', 'steroid, tacrolimus, and azathioprine', 'steroid-free immunosuppression', 'tacrolimus and azathioprine maintenance', 'steroid-free arm (SF-arm) (Basiliximab\xa0+\xa0Tacrolimus and Azathioprine,n\xa0=\xa052) or Steroid arm (S-Arm', 'steroid free immunosuppression with basiliximab induction']","['hypertriglyceridemia', 'patient and graft survival', 'biopsy-proven acute rejection (BPAR) within six months, patient and graft survival', 'metabolic complications', 'time to first rejection', 'incidence of NOSHT', 'BPAR', 'incidence NODAT', 'occurrence of metabolic complications (new-onset diabetes after transplant (NODAT), new-onset systemic hypertension after transplant (NOSHT), post-transplant dyslipidemia']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]",104.0,0.103799,"The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006).","[{'ForeName': 'Manikandan', 'Initials': 'M', 'LastName': 'Kathirvel', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India. Electronic address: dr.manikandan.kathirvel@gmail.com.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Pulkit', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Thillai', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Madhu S', 'Initials': 'MS', 'LastName': 'Durairaj', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Krishnanunni', 'Initials': 'K', 'LastName': 'Nair', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Sunny', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Johns S', 'Initials': 'JS', 'LastName': 'Mathew', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Christi T', 'Initials': 'CT', 'LastName': 'Varghese', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Chandran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Binoj S', 'Initials': 'BS', 'LastName': 'Pillai Thankamony Amma', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Ramachandran N', 'Initials': 'RN', 'LastName': 'Menon', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Sudhindran', 'Initials': 'S', 'LastName': 'Surendran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2020.09.012']
3195,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
3196,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE


The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS


Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS


Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION


Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2020,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
3197,33036063,Patient and caregiver agreement on prognosis estimates for older adults with advanced cancer.,"BACKGROUND


Disagreements between patients and caregivers about treatment benefits, care decisions, and patients' health are associated with increased patient depression as well as increased caregiver anxiety, distress, depression, and burden. Understanding the factors associated with disagreement may inform interventions to improve the aforementioned outcomes.
METHODS


For this analysis, baseline data were obtained from a cluster-randomized geriatric assessment trial that recruited patients aged ≥70 years who had incurable cancer from community oncology practices (University of Rochester Cancer Center 13070; Supriya G. Mohile, principal investigator). Patient and caregiver dyads were asked to estimate the patient's prognosis. Response options were 0 to 6 months, 7 to 12 months, 1 to 2 years, 2 to 5 years, and >5 years. The dependent variable was categorized as exact agreement (reference), patient-reported longer estimate, or caregiver-reported longer estimate. The authors used generalized estimating equations with multinomial distribution to examine the factors associated with patient-caregiver prognostic estimates. Independent variables were selected using the purposeful selection method.
RESULTS


Among 354 dyads (89% of screened patients were enrolled), 26% and 22% of patients and caregivers, respectively, reported a longer estimate. Compared with dyads that were in agreement, patients were more likely to report a longer estimate when they screened positive for polypharmacy (β = 0.81; P = .001), and caregivers reported greater distress (β = 0.12; P = .03). Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
CONCLUSIONS


Several patient and caregiver factors were associated with patient-caregiver disagreement about prognostic estimates. Future studies should examine the effects of prognostic disagreement on patient and caregiver outcomes.",2020,"Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
","['older adults with advanced cancer', 'patients aged ≥70 years who had incurable cancer from community oncology practices (University of Rochester Cancer Center 13070; Supriya G. Mohile, principal investigator']",[],['self-efficacy'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1521895', 'cui_str': 'Principal investigator'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.138278,"Compared with dyads that were in agreement, caregivers were more likely to report a longer estimate when patients screened positive for polypharmacy (β = 0.82; P = .005) and had lower perceived self-efficacy in interacting with physicians (β = -0.10; P = .008).
","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Sindhuja', 'Initials': 'S', 'LastName': 'Kadambi', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McHugh', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Tuch', 'Affiliation': 'Department of Aged Care, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Ramsdale', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yousefi-Nooraie', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sedenquist', 'Affiliation': 'SCOREboard Advisory Group, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Heartland National Cancer Institute Community Oncology Research Program (NCORP), Decatur, Illinois.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Melnyk', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, Delaware.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Geer', 'Affiliation': 'Metro-Minnesota NCORP, St Paul, Minnesota.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.33259']
3198,33036155,"Effects of the Daily Consumption of Stevia on Glucose Homeostasis, Body Weight, and Energy Intake: A Randomised Open-Label 12-Week Trial in Healthy Adults.","Stevia is a non-nutritive sweetener, providing sweet taste with no calories. This randomised, controlled, open-label 2-parallel arm trial examined the effects of daily stevia consumption on glycaemia in healthy adults. Secondary endpoints included body weight (BW) and energy intake (EI). Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ) were randomised into either the stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group ( n  = 14). At weeks 0 and 12, the glucose and insulin responses to an oral glucose tolerance test were measured; BW and EI were assessed at weeks 0, 6, and 12. There was no significant difference in the glucose or insulin responses. There was a significant main effect of group on BW change (F(1,26) = 5.56,  p  = 0.026), as the stevia group maintained their weight as opposed to the control group (mean weight change at week 12: -0.22 kg, 95%CI [-0.96, 0.51] stevia group, +0.89 kg, 95%CI [0.16, 1.63] control group). The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973). Although not placebo-controlled, these results suggest that daily stevia consumption does not affect glycaemia in healthy individuals, but could aid in weight maintenance and the moderation of EI.",2020,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","['Healthy Adults', 'healthy individuals', 'healthy adults', 'Healthy participants ( n  = 28; aged 25 ± 5y, body mass index 21.2 ± 1.7 kg/m 2 ']","['stevia group ( n  = 14)-required to consume a stevia extract daily-or to the control group', 'placebo', 'daily stevia consumption']","['body weight (BW) and energy intake (EI', 'energy intake', 'Glucose Homeostasis, Body Weight, and Energy Intake', 'glucose or insulin responses', 'glucose and insulin responses to an oral glucose tolerance test']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0075246', 'cui_str': 'stevioside'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",28.0,0.0416548,"The energy intake was significantly decreased between week 0 and 12 in the stevia group ( p  = 0.003), however no change was found in the control group ( p  = 0.973).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Crooks', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester M13 9PL, UK.'}]",Nutrients,['10.3390/nu12103049']
3199,33036366,Biopsy-Controlled Non-Invasive Quantification of Collagen Type VI in Kidney Transplant Recipients: A Post-Hoc Analysis of the MECANO Trial.,"The PRO-C6 assay, a reflection of collagen type VI synthesis, has been proposed as a non-invasive early biomarker of kidney fibrosis. We aimed to investigate cross-sectional and longitudinal associations between plasma and urine PRO-C6 and proven histological changes after kidney transplantation. The current study is a post-hoc analysis of 94 participants of the MECANO trial, a 24-month prospective, multicenter, open-label, randomized, controlled trial aimed at comparing everolimus-based vs. cyclosporine-based immunosuppression. PRO-C6 was measured in plasma and urine samples collected 6 and 24 months post-transplantation. Fibrosis was evaluated in biopsies collected at the same time points by Banff interstitial fibrosis/tubular atrophy (IF/TA) scoring and collagen staining (Picro Sirius Red; PSR); inflammation was evaluated by the tubulo-interstitial inflammation score (ti-score). Linear regression analyses were performed. Six-month plasma PRO-C6 was cross-sectionally associated with IF/TA score (Std. β = 0.34), and prospectively with 24-month IF/TA score and ti-score (Std. β = 0.24 and 0.23, respectively) ( p  < 0.05 for all). No significant associations were found between urine PRO-C6 and any of the biopsy findings. Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy. These results are a first step towards non-invasive fibrosis detection after kidney transplantation by means of collagen VI synthesis measurement, and further research is required.",2020,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"['kidney transplantation', 'Kidney Transplant Recipients', '94 participants of the MECANO trial']",['everolimus-based vs. cyclosporine-based immunosuppression'],"['PRO-C6', 'urine PRO-C6', 'collagen staining (Picro Sirius Red; PSR); inflammation', 'Fibrotic changes and urine PRO-C6', '24-month IF/TA score and ti-score']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3887486', 'cui_str': 'Interstitial fibrosis'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1265831', 'cui_str': 'Interstitial inflammation'}]",94.0,0.0197494,Fibrotic changes and urine PRO-C6 behaved differentially over time according to immunosuppressive therapy.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Yepes-Calderón', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Camilo G', 'Initials': 'CG', 'LastName': 'Sotomayor', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Daniel Guldager Kring', 'Initials': 'DGK', 'LastName': 'Rasmussen', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Ryanne S', 'Initials': 'RS', 'LastName': 'Hijmans', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Te Velde-Keyzer', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'van Londen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'van Dijk', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Diepstra', 'Affiliation': 'Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Morten Asser', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Frederike J', 'Initials': 'FJ', 'LastName': 'Bemelman', 'Affiliation': 'Department of Nephrology, Amsterdam University Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, University of Leiden, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kers', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Florquin', 'Affiliation': 'Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, 1098 XH Amsterdam, The Netherlands.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genovese', 'Affiliation': 'Nordic Bioscience A/S, 2730 Herlev, Denmark.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jan-Stephan', 'Initials': 'JS', 'LastName': 'Sanders', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Den Born', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9103216']
3200,33036371,"Combining Effect and Process Evaluation on European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family-Involved Cluster Randomized Controlled Trial: The ToyBox Study.","This study aimed at (1) studying the effect of the standardized ToyBox intervention on European preschoolers' snacking behavior, and (2) studying whether a higher process evaluation score from teachers and parents/caregivers was associated with a more positive result for preschoolers' snack intake. A sample of 4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire. To investigate the effect of the intervention, multilevel repeated measures analyses were executed for the total sample and the six country-specific samples. Furthermore, questionnaires to measure process evaluation were used to compute a total process evaluation score for teachers and parents/caregivers. No significant intervention effects on preschoolers' snack intake were found (all  p  > 0.003). In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores. The lack of effects could be due to limited intervention duration and dose. To induce larger effects on preschoolers' snack intake, a less standardized intervention which is more tailored to the local needs might be needed.",2020,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","['4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire', ""European preschoolers' snacking behavior, and (2"", ""European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family""]",['standardized ToyBox intervention'],"[""preschoolers' snack intake"", 'snack intake']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4517459', 'cui_str': '0.44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",4970.0,0.0814874,"In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores.","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Verbestel', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, 9000 Ghent, Belgium.'}, {'ForeName': 'Maïté', 'Initials': 'M', 'LastName': 'Verloigne', 'Affiliation': 'Research Foundation Flanders, 1000 Brussels, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, University of Thessaly, Sport Science and Dietetics, 421 00 Trikala, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Department of Physiatry and Nursing, GENUD (Growth, Exercise, Drinking Behaviour and Development), University of Zaragoza, 50001 Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Pediatrics, Medical University Varna, 9002 Varna, Bulgaria.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Dr. von Hauner Children's Hospital, University of Munich Medical Centre, 80337 Munich, Germany.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Socha', 'Affiliation': ""Children's Memorial Institute, 04-730 Warsaw, Poland.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, 17778 Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, 9000 Ghent, Belgium.'}]",International journal of environmental research and public health,['10.3390/ijerph17197312']
3201,33036504,"[A comparative study on the efficacy of transoral vestibular approach, via bilateral areola approach endoscopic and open thyroidectomy on stage T1b papillary thyroid carcinoma].","Objective:  To compare the surgical efficacy and cosmetic satisfaction of the transoral endoscopic thyroidectomy by vestibular approach (TOETVA), endoscopic thyroidectomy via bilateral areola approach (BAA), and open thyroidectomy (OT) in the treatment of papillary thyroid carcinoma (PTC) in stage T1b.  Methods:  A total of 178 patients with PTC in stages pT1bN0M0 and pT1bN1aM0 treated from January 2017 to December 2018 were divided into TOETVA group ( n =59), BAA group ( n =43), and OT group ( n =76). The baseline characteristics, relevant indexes of surgical efficacy and follow-up data were compared between the three groups, and also the surgical efficacy indexes were compared between unilateral lobectomy + central lymph node dissection (unilateral lobectomy subgroup) and bilateral lobectomy + central lymph nodes dissection (total resection subgroup). SPSS 19.0 statistical software was used for data analysis.  Results:  The mean ages of patients in TOETVA group and BAA group were significantly younger than those in OT group, and the proportion of women in TOETVA group and BAA group was significantly higher than that in OT group, all  P <0.05. None of patients in TOETVA and BAA groups were converted to open surgery. Among TOETVA, BAA and OT groups, there were significant differences in the mean operation time [unilateral lobectomy subgroup: (198.0±45.2) min, (162.0±36.9) min and (79.4±28.6) min,  P <0.05; total resection subgroup: (230.0±36.0) min, (219.8±68.1) min and (102.8±40.0) min,  P <0.05], in total drainage volume [unilateral lobectomy subgroup: (195.0±55.6) ml, (178.1±50.4) ml and (127.0±30.1) ml,  P <0.05; total resection subgroup: (221.1±46.7) ml, (245.3±71.2) ml and (137.7±41.6) ml,  P <0.05], and the incidence of subcutaneous ecchymosis in TOETVA group or BAA group was higher than that in the OT group [5.1% (3/59), 11.6% (5/43)  vs.  0, χ(2)=3.952 and 9.225 respectively, both  P <0.05]. The mean level of C-reactive protein in TOETVA group was higher than that in OT group [(16.8±10.7)  vs.  (9.5±6.9),  P <0.05]. Following-up in the third month after surgery between three groups in cosmetic satisfaction scores [(2.7±0.5)  vs.  (2.6±0.7)  vs.  (1.7±0.8)], scar self-consciousness scores (0[0,1]  vs.  1[0,2]  vs.  2[1,2]), and quality of life scores [(9.1±1.1)  vs.  (8.9±1.1)  vs.  (7.5±0.8)], cosmetic satisfaction and quality of life in TOETVA and BAA group were better than that in OT group, in terms of scar self-consciousness: TOETVA<BAA<OT (all  P <0.05). But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05). The median follow-up time of the three groups was 25 months (TOETVA group), 28 months (BAA group), and 32 months (OT group) respectively, without disease progression.  Conclusion:  TOETVA and BAA are optional surgical methods for PTC in stages pT1bN0M0 and pT1bN1aM0, with good safety and patient's cosmetic satisfaction.",2020,But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05).,"['178 patients with PTC in stages pT1bN0M0 and pT1bN1aM0 treated from January 2017 to December 2018', 'total resection subgroup', 'papillary thyroid carcinoma (PTC) in stage T1b', 'stage T1b papillary thyroid carcinoma']","['unilateral lobectomy + central lymph node dissection (unilateral lobectomy subgroup) and bilateral lobectomy + central lymph nodes dissection', 'BAA', 'transoral vestibular approach, via bilateral areola approach endoscopic and open thyroidectomy', 'transoral endoscopic thyroidectomy by vestibular approach (TOETVA), endoscopic thyroidectomy via bilateral areola approach (BAA), and open thyroidectomy (OT']","['mean level of C-reactive protein', 'mean operation time', 'cosmetic satisfaction scores', 'scar self-consciousness scores', 'cosmetic satisfaction and quality of life', 'surgical efficacy and cosmetic satisfaction', 'levels of Tg or TgAb', 'total drainage volume', 'median follow-up time', 'quality of life scores', 'surgical efficacy indexes', 'incidence of subcutaneous ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",178.0,0.0271133,But there were no significant differences in the levels of Tg or TgAb between three groups for total resection subgroup (all  P >0.05).,"[{'ForeName': 'Z D', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xiang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid Surgery, Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou 310009, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20200520-00430']
3202,33036505,[Clinical application of the gasless unilateral axillary approach in endoscopic thyroid surgery].,"Objective:  To investigate the efficacy, safety and advantages of gasless unilateral axillary approach (GUAA) in endoscopic thyroid surgery.  Methods:  A total of 334 patients who underwent the GUAA endoscopic thyroid surgery (GUAA group) or conventional open thyroid surgery (OS group) in the Department of Head and Neck Surgery of Zhejiang Cancer Hospital from January 2017 to June 2018 were retrospectively analyzed. There were 45 males and 289 females, aged from 12 to 72 years old, of whom 139 patients were assigned to GUAA group and 195 patients to OS group. Pathological results included papillary thyroid carcinoma (282 cases), nodular goiter (41 cases) and thyroid adenoma (11 cases). Surgical exploration development curve of GUAA group was drawn and was divided into two parts: the technical exploration stage and the technical stable stage. Surgical efficiency, incidences of complications, and incision satisfaction were compared between GUAA group in technical stable stage and OS group. SPSS 25.0 software was adopted for statistical analysis.  Results:  The mean age in GUAA group was younger than that in OS group, with a significant difference [(35.3±9.5) years  vs.  (48.1±10.6) years,  t =11.31,  P <0.01]. The cases in the endoscope group were divided into technical exploration stage for 51 cases and technical stable stage for 88 cases according to the exploration and development curve. In unilateral radical thyroidectomy and unilateral thyroid lobectomy, the mean operation time [(90.6±18.6) min and (93.5±22.0) min] and postoperative drainage volumes [(121.5±87.6) ml and (155.5±69.1) ml] of GUAA group in the stable stage were more than those of OS group [(61.6±15.6) min and (46.5±8.4) min] and [(93.2±42.3) ml and (78.9±48.7) ml]. The difference was statistically significant ( t =12.28, 7.23, 3.35 and 3.05 respectively, all  P <0.05), but there were no significant differences in surgical bleeding volumes between two groups [(12.7±6.8) ml  vs.  (13.5±7.7) ml,  t =0.74,  P >0.05 and (16.3±14.1) ml  vs.  (11.9±5.1) ml,  t =1.05,  P >0.05]. Compared with OS group, GUAA group had the lower incidence of anterior cervical discomfort during swallowing (2.3%  vs.  29.2%,  P <0.01) and the higher incision satisfaction score (1.1±0.5  vs.  2.8±0.7,  t =21.12,  P <0.01), however, GUAA group had the higher incidence of supraclavicular (or infraclavicular) numbness after surgery (5.7%  vs.  0,  P <0.01). And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  Conclusion:  GUAA endoscopic thyroid surgery is a safe method with high cosmetic satisfaction.",2020,"And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  ","['group and 195 patients to OS group', 'OS group) in the Department of Head and Neck Surgery of Zhejiang Cancer Hospital from January 2017 to June 2018 were retrospectively analyzed', 'endoscopic thyroid surgery', '45 males and 289 females, aged from 12 to 72 years old, of whom 139 patients', 'papillary thyroid carcinoma (282 cases), nodular goiter (41 cases) and thyroid adenoma (11 cases', '334 patients who underwent the']","['GUAA endoscopic thyroid surgery', 'GUAA endoscopic thyroid surgery (GUAA group) or conventional open thyroid surgery', 'unilateral radical thyroidectomy and unilateral thyroid lobectomy', 'GUAA', 'gasless unilateral axillary approach', 'gasless unilateral axillary approach (GUAA']","['incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage', 'anterior cervical discomfort during swallowing', 'incidence of supraclavicular (or infraclavicular) numbness', 'mean operation time', 'Surgical efficiency, incidences of complications, and incision satisfaction', 'higher incision satisfaction score', 'surgical bleeding volumes', 'postoperative drainage volumes']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0238463', 'cui_str': 'Papillary thyroid carcinoma'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0018023', 'cui_str': 'Nodular goiter'}, {'cui': 'C0151468', 'cui_str': 'Thyroid adenoma'}, {'cui': 'C4517729', 'cui_str': '334'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C1562241', 'cui_str': 'Axillary approach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C2077203', 'cui_str': 'Recurrent Laryngeal Nerve Injury'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0443174', 'cui_str': 'Chylous'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",139.0,0.0225002,"And there was no significant difference in the incidences of temporary recurrent laryngeal nerve injury, bleeding, hematoma, infection, lymphatic leakage or chylous leakage after surgery between two groups ( P >0.05).  ","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'L Z', 'Initials': 'LZ', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053, China.'}, {'ForeName': 'Q H', 'Initials': 'QH', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou 310053, China.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Guo', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Jiang', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Zheng', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Ge', 'Affiliation': ""Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China.""}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Lan', 'Affiliation': 'Department of Head and Neck Surgery, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou 310022, China.'}]",Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery,['10.3760/cma.j.cn115330-20200225-00126']
3203,33036588,The contribution of serum cortisone and glucocorticoid metabolites to detrimental bone health in patients receiving hydrocortisone therapy.,"BACKGROUND


Glucocorticoid therapy is the most common cause of iatrogenic osteoporosis. Less is known regarding the effect of glucocorticoids when used as replacement therapy on bone remodelling in patients with adrenal insufficiency. Enhanced intracellular conversion of inactive cortisone to active cortisol, by 11 beta-hydroxysteroid dehydrogenase type 1(11β-HSD1) and other enzymes leading to alterations in glucocorticoid metabolism, may contribute to a deleterious effect on bone health in this patient group.
METHODS


Study design: An open crossover prospective study randomizing ten hypopituitary men, with severe ACTH deficiency, to three commonly used hydrocortisone dose regimens.
MEASUREMENTS


Following 6 weeks of each regimen, patients underwent 24-h serum cortisol/cortisone sampling, measurement of bone turnover markers, and a 24-h urine collection for measurement of urinary steroid metabolites by gas chromatography-mass spectrometry (GC-MS). Serum cortisone and cortisol were analysed by liquid chromatography-mass spectrometry (LC-MS).
RESULTS


Dose-related and circadian variations in serum cortisone were seen to parallel those for cortisol, indicating conversion of ingested hydrocortisone to cortisone. The median area under the curve (AUC) of serum cortisone was significantly higher in patients on dose A (20 mg/10 mg) [670.5 (IQR 621-809.2)] compared to those on dose C (10 mg/5 mg) [562.8 (IQR 520.1-619.6), p = 0.01]. A negative correlation was observed between serum cortisone and bone formation markers, OC [1-49] (r = - 0.42, p = 0.03), and PINP (r = - 0.49, p = 0.01). There was a negative correlation between the AUC of night-time serum cortisone levels with the bone formation marker, OC [1-49] (r = - 0.41, p = 0.03) but there were no significant correlations between day-time serum cortisone or cortisol with bone turnover markers. There was a negative correlation between total urinary cortisol metabolites and the bone formation markers, PINP (r = - 0.39, p = 0.04), and OC [1-49] (r = - 0.35, p = 0.06).
CONCLUSION


Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
TRIAL REGISTRATION


Irish Medicines Board Clinical Trial Number - CT900/459/1 and EudraCT Number - 2007-005018-37 . Registration date: 07-09-2007.",2020,"Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
","['ten hypopituitary men, with severe ACTH deficiency, to three commonly used hydrocortisone dose regimens', 'patients with adrenal insufficiency', 'patients receiving hydrocortisone therapy', 'patients receiving replacement doses of']","['glucocorticoids', 'hydrocortisone', 'Glucocorticoid therapy']","['bone health', 'Serum cortisone and cortisol', 'total urinary cortisol metabolites and the bone formation markers, PINP', 'Serum cortisol and cortisone and total urinary corticosteroid metabolites', 'serum cortisone and bone formation markers, OC [1-49] ', 'AUC of night-time serum cortisone levels', 'median area under the curve (AUC) of serum cortisone', 'bone turnover']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0342388', 'cui_str': 'ACTH deficiency'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",10.0,0.0281475,"Serum cortisol and cortisone and total urinary corticosteroid metabolites are negatively associated with bone turnover markers in patients receiving replacement doses of hydrocortisone, with nocturnal glucocorticoid exposure having a potentially greater influence on bone turnover.
","[{'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Dineen', 'Affiliation': 'Department of Endocrinology, Tallaght University Hospital, Dublin, Ireland. rosedineen@gmail.com.'}, {'ForeName': 'Lucy-Ann', 'Initials': 'LA', 'LastName': 'Behan', 'Affiliation': 'Department of Endocrinology, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Kelleher', 'Affiliation': 'Department of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hannon', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Brady', 'Affiliation': ""Metabolism Laboratory, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Manchester Academic Health Science Centre, University Hospital of South Manchester, The University of Manchester, Manchester, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tormey', 'Affiliation': 'Department of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Thompson', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Malachi J', 'Initials': 'MJ', 'LastName': 'McKenna', 'Affiliation': ""Metabolism Laboratory, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'Medical School, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Agha', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sherlock', 'Affiliation': 'Academic Department of Endocrinology, Beaumont Hospital and Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",BMC endocrine disorders,['10.1186/s12902-020-00633-1']
3204,33036591,Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial.,"BACKGROUND


With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia.
METHODS


The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia.
DISCUSSION


This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139.",2020,"This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
","['people with dementia', '372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners', 'Early-stage dementia with e-learning for carers (SHAPE', 'people with mild to moderate dementia']","['SHAPE group intervention', 'Self-management and HeAlth Promotion']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]",[],372.0,0.120627,"This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia.
","[{'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Testad', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway. itestad@gmail.com.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': ""REACH: The Centre for Research in Ageing and Cognitive Health, University of Exeter, St Luke's Campus, Exeter, UK.""}, {'ForeName': 'Kaarin', 'Initials': 'K', 'LastName': 'Anstey', 'Affiliation': 'UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Selbæk', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Guro Hanevold', 'Initials': 'GH', 'LastName': 'Bjørkløf', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Dalen', 'Affiliation': 'Department of Research, Section of Biostatistics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martha Therese', 'Initials': 'MT', 'LastName': 'Gjestsen', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Røsvik', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bollen', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Amos', 'Affiliation': 'UNSW Ageing Futures Institute, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Martine Marie', 'Initials': 'MM', 'LastName': 'Kajander', 'Affiliation': 'Centre for Age-related Medicine - SESAM, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Care Policy and Evaluation Centre, Department of Health Policy, London School of Economics and Political Science, London, UK.'}]",BMC public health,['10.1186/s12889-020-09590-9']
3205,33036605,Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial.,"BACKGROUND


Family involvement for persons with psychotic disorders is under-implemented in mental health care, despite its firm scientific, economic, legal and moral basis. This appears to be the case in Norway, despite the presence of national guidelines providing both general recommendations on family involvement and support in the health- and care services, and specific guidance on family interventions for patients with psychotic disorders. The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
METHODS


The trial is cluster randomised, where 14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1. The seven intervention clusters will receive implementation support for 18 months, whereas the control clusters will receive the same support after this implementation period. The intervention consists of: 1. A basic level of family involvement and support. 2. Family psychoeducation in single-family groups. 3. Training and guidance of health care personnel. 4. A family coordinator and 5. Other implementation measures. Fidelity to the intervention will be measured four times in the intervention arm and two times in the control arm, and the differences in fidelity changes between the arms constitute the primary outcomes. In each arm, we aim to include 161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6 months and 12 months, measuring psychosocial health and satisfaction with services. Clinicians will contribute clinical data about patients at inclusion and 12 months. Use of health and welfare services and work participation, for both patients and relatives, will be retrieved from national registries. We will also perform qualitative interviews with patients, relatives, health care personnel and leaders. Finally, we will conduct a cost-effectiveness analysis and a political economy analysis.
DISCUSSION


This project, with its multilevel and mixed methods approach, may contribute valuable knowledge to the fields of family involvement, mental health service research and implementation science.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.",2020,"The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
","['patients with psychotic disorders', 'persons with psychotic disorders', 'persons with psychotic disorders in community mental health centres (IFIP', '14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1', '161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6\u2009months and 12\u2009months, measuring psychosocial health and satisfaction with services', 'persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres']",[],"['mental health services', 'fidelity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0557090', 'cui_str': 'Closest relatives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],"[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",161.0,0.0663029,"The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hestmark', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway. lars.hestmark@medisin.uio.no.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Romøren', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Kristin Sverdvik', 'Initials': 'KS', 'LastName': 'Heiervang', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Weimand', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Sykehusveien 25, 1474, Nordbyhagen, Norway.'}, {'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Reidun', 'Initials': 'R', 'LastName': 'Norvoll', 'Affiliation': 'Work Research Institute, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Kristiane Myckland', 'Initials': 'KM', 'LastName': 'Hansson', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Norheim', 'Affiliation': 'Division of Mental Health and Addiction, Vestre Viken Hospital Trust, Lier, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elisabeth Geke Marjan', 'Initials': 'EGM', 'LastName': 'Landeweer', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}, {'ForeName': 'Reidar', 'Initials': 'R', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Medical Ethics, University of Oslo, Kirkeveien 166 Fredrik Holsts hus, 0450, Oslo, Norway.'}]",BMC health services research,['10.1186/s12913-020-05792-4']
3206,33036638,Octyl-2-cyanoacrylate tissue adhesive without subcuticular suture for wound closure after total hip arthroplasty: a prospective observational study on thirty-two cases with controls for 3 months follow-up.,"BACKGROUND


Whether using tissue adhesive alone after subcutaneous suture can close the skin incision with safety as well as cosmetic appearance after total hip arthroplasty was not clear.
METHODS


A prospective study was conducted. The same surgical methods were consistent throughout the entire study. After implanting prosthesis, the joint capsule was reconstructed. Fascial and subcutaneous layer were respectively closed by continuous running barbed suture. Patients were randomized allocated to group A with octyl-2-cyanoacrylate tissue adhesive alone, to group B with tissue adhesive after continuous subcuticular suture, or to group C with skin staples. Time of closure, drainage, pain, wound complications, and cosmesis were compared. All data were analyzed statistically.
RESULTS


There was no significant difference in drainage, Visual Analog Scale score or early wound complications between the three groups. However, there was significant difference in time of closure (P = 0.013). In pairwise comparison, time of closure in groups A and B was significantly longer than those in group C (P = 0.001 and P = 0.023, respectively); time of closure in group A was significantly shorter than those in group B (P = 0.003). Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
CONCLUSION


Tissue adhesive without subcuticular suture was similar with a combination of subcuticular suture and tissue adhesive as well skin staples in terms of safety and cosmetic appearance after total hip arthroplasty.",2020,"Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
","['thirty-two cases with controls for 3\u2009months follow-up', 'wound closure after total hip arthroplasty']","['Tissue adhesive without subcuticular suture', 'Octyl-2-cyanoacrylate tissue adhesive without subcuticular suture', 'octyl-2-cyanoacrylate tissue adhesive alone, to group B with tissue adhesive after continuous subcuticular suture, or to group C with skin staples']","['Fascial and subcutaneous layer', 'Time of closure, drainage, pain, wound complications, and cosmesis', 'time of closure', 'drainage, Visual Analog Scale score or early wound complications', 'Patient and Observer Scar Assessment Scale total scores']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0391770', 'cui_str': '2-octyl cyanoacrylate'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1139841', 'cui_str': 'Skin staple'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0148424,"Patient and Observer Scar Assessment Scale total scores were not significantly different at 6 weeks and 3 months postoperatively (P = 0.078 and P = 0.284, respectively).
","[{'ForeName': 'Li-Shen', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Xin-Yu', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Hao-Tian', 'Initials': 'HT', 'LastName': 'Tu', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China. qixindoc@163.com.'}, {'ForeName': 'Yu-Hang', 'Initials': 'YH', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedic Surgery, The First Hospital of Jilin University, Changchun, Jilin, 130021, China. gaoyuhangdoc@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01997-9']
3207,33036645,The effect of early oral stimulation with breast milk on the feeding behavior of infants after congenital cardiac surgery.,"OBJECTIVE


To investigate the effect of early oral stimulation with breast milk on the feeding behavior of infants after congenital cardiac surgery.
METHODS


Infants with congenital heart disease were randomly divided into the breast milk oral stimulation group (n = 23), physiological saline oral stimulation group (n = 23) and control group (n = 23). Debra Beckman's oral exercise program was used with breast milk and physiological saline in the breast milk oral stimulation group and the physiological saline oral stimulation group, respectively. The time oral feeding and total oral nutrition were started, the length of intensive care unit (ICU) stay and hospital stay, weight and the complications at discharge were recorded for each group and statistically analyzed.
RESULTS


The time oral feeding and total oral nutrition were started and the length of ICU stay and hospital stay were significantly less in the breast milk oral stimulation group and physiological saline oral stimulation group than in the control group (P < 0.05). There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05). However, there were no significant differences in weight or complications at discharge among the three groups (P > 0.05).
CONCLUSION


Early oral stimulation exercises with breast milk can help infant patients quickly recover total oral nutrition and reduce the length of ICU and hospital stay after cardiac surgery.",2020,"There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05).","['Infants with congenital heart disease', 'infants after congenital cardiac surgery']","['breast milk oral stimulation group (n\xa0=\u200923), physiological saline oral stimulation group (n\xa0=\u200923) and control group', ""Debra Beckman's oral exercise program""]","['length of intensive care unit (ICU) stay and hospital stay, weight and the complications at discharge', 'weight or complications', 'length of ICU and hospital stay', 'time total oral nutrition began', 'time oral feeding and total oral nutrition', 'length of ICU stay and hospital stay']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",,0.0213002,"There were no significant differences in other indicators between the breast milk oral stimulation group and the physiological saline oral stimulation group, except for the time total oral nutrition began (P < 0.05).","[{'ForeName': 'Xian-Rong', 'Initials': 'XR', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Li-Wen', 'Initials': 'LW', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zeng-Chun', 'Initials': 'ZC', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01355-0']
3208,33036655,Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial.,"BACKGROUND


Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia.
METHODS


A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention.
DISCUSSION


It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.",2020,Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression.,"['Retrospectively registered on 14 January 2020', 'people with major depression and insomnia', '285 non-suicidal Hong Kong Chinese older than 17\u2009years of age with major depression and insomnia', 'individuals with comorbid insomnia and depression']","['smartphone application proACT-S', 'CBT-I delivered via smartphone application', 'self-help smartphone-based CBT-I', 'CBT-I immediately or to a waitlist control condition', 'smartphone-delivered self-help cognitive behavioral therapy', 'cognitive behavioral therapy']","['changes over the measurement points in sleep quality, insomnia severity, and depression severity', 'changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",285.0,0.0880273,Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression.,"[{'ForeName': 'Victoria Ka-Ying', 'Initials': 'VK', 'LastName': 'Hui', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Christy Yim-Fan', 'Initials': 'CY', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Eric Ka-Yiu', 'Initials': 'EK', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong.'}, {'ForeName': 'Fiona Yan-Yee', 'Initials': 'FY', 'LastName': 'Ho', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong SAR, Hong Kong. shaunlyn@hku.hk.'}]",Trials,['10.1186/s13063-020-04778-1']
3209,32769414,High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.,"OBJECTIVES


There is good evidence that spinal cord stimulation (SCS) is effective for reducing chronic back and leg pain (CBLP). SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
METHODS


A probabilistic decision tree and Markov decision analytic model was used to synthesize data on CBLP outcomes and costs over a 15-year time horizon from a UK National Health Service perspective using data from the SENZA randomized controlled trial and other publications. Results are expressed as incremental cost per quality-adjusted life year (QALY) in 2016 Pounds Sterling.
RESULTS


10 kHz-SCS is cost-saving and cost-effective compared with LF-SCS, with mean cost-savings of £7170 (95% confidence interval: £6767-£7573) and £3552 (95% confidence interval: £3313-£3792) per patient compared with nonrechargeable and rechargeable LF-SCS devices, respectively. 10 kHz-SCS has a 95% likelihood of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Our findings were robust across a wide range of sensitivity analyses.
CONCLUSIONS


There is a strong economic case for choosing 10 kHz-SCS over LF-SCS for CBLP. Furthermore, 10 kHz-SCS has clinical advantages not captured in our analysis, including shorter, and more predictable procedure times.",2020,"SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
",[],"['frequency (10\u2009kHz) stimulation (10\u2009kHz-SCS', 'spinal cord stimulation (SCS', 'High-frequency 10\u2009kHz Spinal Cord Stimulation']","['cost-saving and cost-effective', 'chronic back and leg pain (CBLP', 'mean cost-savings']",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.145027,"SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.
","[{'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Well Being, University of Glasgow, Glasgow.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bentley', 'Affiliation': 'Mtech Access Limited, Bicester, Oxfordshire, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Campbell', 'Affiliation': 'University of Exeter Medical School, Exeter.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Nevro Corporation, Redwood City, CA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000866']
3210,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES


Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS


In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS


Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION


Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
3211,33033088,"Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial.","INTRODUCTION


Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
METHODS AND ANALYSIS


A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.
ETHICS AND DISSEMINATION


Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12619001134112.",2020,"This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
","['adults compared with no treatment (control', 'low back pain recurrence in adults']","['six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education', 'RCT comparing walking and education', 'progressive and individualised walking and education programme (intervention', 'progressive, individualised walking and education programme']","['effectiveness and cost-effectiveness', 'LBP recurrences', 'days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life', 'LBP recurrence', 'days to first recurrence of an episode of activity-limiting LBP', 'Effectiveness and cost-effectiveness', 'survival curves']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.201652,"This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).
","[{'ForeName': 'Natasha Celeste', 'Initials': 'NC', 'LastName': 'Pocovi', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia tash.pocovi@mq.edu.au.'}, {'ForeName': 'Chung-Wei C', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Merom', 'Affiliation': 'Department of Physical Activity and Health, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Macaskill', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Clavisi', 'Affiliation': 'Musculoskeletal Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shuk Yin Kate', 'Initials': 'SYK', 'LastName': 'Tong', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-037149']
3212,33033091,Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia for patients with critical limb ischaemia: a study protocol for a randomised controlled trial.,"INTRODUCTION


Both regional analgesia and intravenous analgesia are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect of regional and intravenous analgesia has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA) as two different perioperative analgesia approaches for patients with CLI. It investigates their effects on analgesia, reperfusion and the quality of recovery perioperatively, also aims to provide clinical evidence to those non-surgical patients with non-reconstructable arteries.
METHODS AND ANALYSIS


This trial is a randomised, single-centre, open-label, parallel trial with target sample size of 52 in total. Eligible participants will be randomly allocated to the PCRA group (group R) or the PCIA group (group I) after admission. Participants in group R will receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine 15 mL as loading dose, 8 mL/hour as background with a patient-controlled bolus of 6 mL). Participants in group I will receive PCIA (morphine is given in boluses of 1 mg as needed, background infusion at 1 mg/hour). Data will be collected at baseline (T0), 2 hours before revascularisation treatment (T1) and 2 hours before discharge (T2). The primary outcomes include the Numerical Rating Scale pain score at T1 and T2. The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
ETHICS AND DISSEMINATION


This study received authorisation from the Institutional Review Board of Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000029298).
PROTOCOL VERSION


V.4CP.B2 (15 June 2020).",2020,"The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
","['patients with critical limb ischaemia', 'patients with CLI', 'Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X', 'V.4CP.B2 (15 June 2020', 'surgical patients with non-reconstructable arteries', 'patients with critical limb ischaemia (CLI', 'Eligible participants']","['PCRA', 'ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine', 'Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia', 'patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA', 'PCIA (morphine', 'PCIA']","['perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events', 'Numerical Rating Scale pain score at T1 and T2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.17805,"The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Zhonghuang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hongju', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Surgery, Peking Union Medical College Hospital, Beijing, China yuehongzheng@yahoo.com.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2020-037879']
3213,33033621,Systematic development of an injury prevention programme for judo athletes: the IPPON intervention.,"Objectives


To systematically develop an injury prevention programme in judo and test its feasibility: Injury Prevention and Performance Optimization Netherlands (IPPON) intervention.
Methods


We used the five-step Knowledge Transfer Scheme (KTS) guidelines. In the first two steps, we described the injury problem in judo and showed possibilities to reduce the injury rates. In the third step, the Knowledge Transfer Group (KTG) translated this information into actions in judo practice. Expert meetings and practical sessions were held. In the fourth step, we developed the injury prevention programme and evaluated its feasibility in judo practice in a pilot study. As a final step, we will evaluate the injury prevention programme on its effectiveness to reduce injuries.
Results


In the first two steps, information collected indicated the need for reducing judo injuries due to high incidence rates. Injury prevention programmes have shown to be effective in reducing injuries in other sports. For judo, no injury prevention programme has yet been systematically developed. In the third step, the KTG reached consensus about the content: a trainer-based warm-up programme with dynamic exercises focusing on the shoulder, knee and ankle. In the fourth step, the intervention was developed. All exercises were approved in the pilot study. Based on the pilot study's results, the IPPON intervention was extended and has become suitable for the final step.
Conclusion


We developed the IPPON intervention using the systematic guidance of the KTS. This trainer-based programme focuses on the prevention of shoulder, knee and ankle injuries in judo and consists of 36 exercises classified in three categories: (1) flexibility and agility, (2) balance and coordination and (3) strength and stability. The effectiveness and feasibility of the intervention on injury reduction among judo athletes will be conducted in a randomised controlled trial.",2020,"Based on the pilot study's results, the IPPON intervention was extended and has become suitable for the final step.
","['shoulder, knee and ankle injuries in judo and consists of 36 exercises classified in three categories: (1', 'judo athletes']","['Knowledge Transfer Group (KTG', 'IPPON intervention', 'Performance Optimization Netherlands (IPPON) intervention', 'injury prevention programme']","['flexibility and agility, (2) balance and coordination and (3) strength and stability']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}, {'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",36.0,0.0231535,"Based on the pilot study's results, the IPPON intervention was extended and has become suitable for the final step.
","[{'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'von Gerhardt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam (UvA), Department of Orthopaedic Surgery, Amsterdam Movement Sciences (AMS), Amsterdam, The Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Vriend', 'Affiliation': 'Amsterdam Collaboration on Health and Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Amsterdam Collaboration on Health and Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Academic Center for Evidence-Based Sports Medicine (ACES), Amsterdam UMC, Amsterdam Movement Sciences (AMS), Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, University of Amsterdam (UvA), Department of Orthopaedic Surgery, Amsterdam Movement Sciences (AMS), Amsterdam, The Netherlands.'}, {'ForeName': 'Guus', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Academic Center for Evidence-Based Sports Medicine (ACES), Amsterdam UMC, Amsterdam Movement Sciences (AMS), Amsterdam, The Netherlands.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2020-000791']
3214,33033622,Yoga-based exercise to prevent falls in community-dwelling people aged 60 years and over: study protocol for the Successful AGEing (SAGE) yoga randomised controlled trial.,"Introduction


Falls significantly reduce independence and quality of life in older age. Balance-specific exercise prevents falls in people aged 60+ years. Yoga is growing in popularity and can provide a high challenge to balance; however, the effect of yoga on falls has not been evaluated. This trial aims to establish the effect on falls of a yoga exercise programme compared with a yoga relaxation programme in community-dwellers aged 60+ years.
Method and Analysis


This randomised controlled trial will involve 560 community-dwelling people aged 60+ years. Participants will be randomised to either: (1) the Successful AGEing ( SAGE ) yoga exercise programme or (2) a yoga relaxation programme. Primary outcome is rate of falls in the 12 months post randomisation. Secondary outcomes include mental well-being, physical activity, health-related quality of life, balance self-confidence, physical function, pain, goal attainment and sleep quality at 12 months after randomisation. The number of falls per person-year will be analysed using negative binomial regression models to estimate between-group difference in fall rates. Generalised linear models will assess the effect of group allocation on the continuously scored secondary outcomes, adjusting for baseline scores. An economic analysis will compare the cost-effectiveness and cost-utility of the two yoga programmes.
Ethics and dissemination


Protocol was approved by the Human Research Ethics Committee at The University of Sydney, Australia (approval 2019/604). Trial results will be disseminated via peer-reviewed articles, conference presentations, lay summaries.
Trial registration number


The protocol for this trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001183178).",2020,Balance-specific exercise prevents falls in people aged 60+ years.,"['people aged 60+ years', 'community-dwelling people aged 60 years and over', 'older age', '560 community-dwelling people aged 60+ years', 'community-dwellers aged 60+ years']","['Balance-specific exercise', 'yoga exercise programme', 'AGEing ( SAGE ) yoga exercise programme', 'Yoga-based exercise', 'yoga relaxation programme']","['independence and quality of life', 'mental well-being, physical activity, health-related quality of life, balance self-confidence, physical function, pain, goal attainment and sleep quality', 'cost-effectiveness and cost-utility', 'number of falls per person-year', 'rate of falls']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}]",560.0,0.272524,Balance-specific exercise prevents falls in people aged 60+ years.,"[{'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sesto', 'Affiliation': 'Yoga to Go Studio, Petersham, Australia.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Youkhana', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Giane C', 'Initials': 'GC', 'LastName': 'Camara', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Grunseit', 'Affiliation': 'Prevention Research Collaboration, School of Public Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Prevention Research Collaboration, School of Public Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Roberta B', 'Initials': 'RB', 'LastName': 'Shepherd', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2020-000878']
3215,33033765,"Can accelerated transcranial direct current stimulation improve memory functions? An experimental, placebo-controlled study.","The aim of this study was to investigate whether transcranial Direct Current Stimulation (tDCS) could improve verbal memory functions in healthy old and younger participants. We hypothesized that active tDCS led to significantly improved memory function, compared to placebo tDCS. Forty healthy participants (20 old and 20 younger participants) were included in the study. We applied a novel stimulation protocol, where six sessions of anodal tDCS were administrated during two consecutive days. Each tDCS session lasted 30 min. The current intensity was 2mA and the stimulation area was the left temporal lobe at T3 in the 10-20 EEG system. Immediate recall, delayed recall and recognition memory were assessed with California Verbal Learning Test II (CVLT-II) and executive functions were assessed with the Trail Making Test (TMT) before the first tDCS session and after the last tDCS session. Half of the participants received placebo tDCS, whereas the other half received active tDCS. We did not reveal any significant differences between active and placebo tDCS in memory functions. However, there was a significant difference between active and placebo tDCS in executive function measured by the Trail Making Test (TMT). This experimental study failed to reveal significant differences between active and placebo accelerated tDCS for verbal memory functions. However, accelerated tDCS was found to be well-tolerated in this study.",2020,We did not reveal any significant differences between active and placebo tDCS in memory functions.,"['healthy old and younger participants', 'Forty healthy participants (20 old and 20 younger participants']","['transcranial Direct Current Stimulation (tDCS', 'placebo tDCS', 'active tDCS', 'placebo', 'anodal tDCS']","['Trail Making Test (TMT', 'memory function', 'California Verbal Learning Test II (CVLT-II) and executive functions', 'verbal memory functions', 'executive function', 'Immediate recall, delayed recall and recognition memory']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0589055', 'cui_str': 'California verbal learning test'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",40.0,0.0806997,We did not reveal any significant differences between active and placebo tDCS in memory functions.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bystad', 'Affiliation': 'Department of Psychology, Research Group for Cognitive Neuroscience, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Storø', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gundersen', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Ida Larsen', 'Initials': 'IL', 'LastName': 'Wiik', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Nordvang', 'Affiliation': 'Department of Psychology, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Grønli', 'Affiliation': 'Department of Geropsychiatry, University Hospital of North Norway, Norway.'}, {'ForeName': 'Ingrid Daae', 'Initials': 'ID', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Psychology, Research Group for Cognitive Neuroscience, Faculty of Health Sciences, University of Tromsø, Norway.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Aslaksen', 'Affiliation': 'Department of Psychology, Research Group for Cognitive Neuroscience, Faculty of Health Sciences, University of Tromsø, Norway.'}]",Heliyon,['10.1016/j.heliyon.2020.e05132']
3216,33033800,Tadalafil may improve cerebral perfusion in small-vessel occlusion stroke-a pilot study.,"New treatments for cerebral small-vessel disease are needed to reduce the risk of small-vessel occlusion stroke and vascular cognitive impairment. We investigated an approach targeted to the signalling molecule cyclic guanosine monophosphate, using the phosphodiesterase 5 inhibitor tadalafil, to explore if it improves cerebral blood flow and endothelial function in patients with cerebral small-vessel disease and stroke. In a randomized, double-blinded, placebo-controlled, cross-over pilot trial (NCT02801032), we included patients who had a previous (>6 months) small-vessel occlusion stroke. They received a single dose of either 20 mg tadalafil or placebo on 2 separate days at least 1 week apart. We measured the following: baseline MRI for lesion load, repeated measurements of blood flow velocity in the middle cerebral artery by transcranial Doppler, blood oxygen saturation in the cortical microvasculature by near-infrared spectroscopy, peripheral endothelial response by EndoPAT and endothelial-specific blood biomarkers. Twenty patients with cerebral small-vessel disease stroke (3 women, 17 men), mean age 67.1 ± 9.6, were included. The baseline mean values ± standard deviations were as follows: blood flow velocity in the middle cerebral artery, 57.4 ± 10.8 cm/s; blood oxygen saturation in the cortical microvasculature, 67.0 ± 8.2%; systolic blood pressure, 145.8 ± 19.5 mmHg; and diastolic blood pressure, 81.3 ± 9.1 mmHg. We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%. However, we saw no significant differences in transcranial Doppler measurements over time. Tadalafil had no effects on peripheral endothelial function assessed by EndoPAT and endothelial biomarker results conflicted. Our findings suggest that tadalafil may improve vascular parameters in patients with cerebral small-vessel disease stroke, although the effect size was small. Increased oxygenation of cerebral microvasculature during tadalafil treatment indicated improved perfusion in the cerebral microvasculature, theoretically presenting an attractive new therapeutic target in cerebral small-vessel disease. Future studies of the effect of long-term tadalafil treatment on cerebrovascular reactivity and endothelial function are needed to evaluate general microvascular changes and effects in cerebral small-vessel disease and stroke.",2020,We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%.,"['Twenty patients with cerebral small-vessel disease stroke (3 women, 17 men), mean age 67.1\u2009±\u20099.6, were included', 'patients with cerebral small-vessel disease stroke', 'patients with cerebral small-vessel disease and stroke', 'patients who had a previous (>6\u2009months) small-vessel occlusion stroke']","['placebo', 'tadalafil or placebo', 'Tadalafil', 'tadalafil']","['peripheral endothelial function', 'transcranial Doppler measurements', 'blood oxygen saturation', 'vascular parameters', 'cerebral blood flow and endothelial function', 'blood flow velocity', 'cerebrovascular reactivity and endothelial function', 'Increased oxygenation of cerebral microvasculature', 'systolic blood pressure', 'diastolic blood pressure', 'cerebral perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0243079', 'cui_str': 'microvasculature'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",20.0,0.437187,We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%.,"[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Ölmestig', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Ida R', 'Initials': 'IR', 'LastName': 'Marlet', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Rasmus H', 'Initials': 'RH', 'LastName': 'Hansen', 'Affiliation': 'Department of Radiology, Herlev Gentofte Hospital, Herlev 2730, Denmark.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Rehman', 'Affiliation': 'Department of Radiology, Herlev Gentofte Hospital, Herlev 2730, Denmark.'}, {'ForeName': 'Rikke Steen', 'Initials': 'RS', 'LastName': 'Krawcyk', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Egill', 'Initials': 'E', 'LastName': 'Rostrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, Mental Health Center Glostrup, Capital Region Psychiatry, Glostrup 2600, Denmark.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Lambertsen', 'Affiliation': 'Department of Neurobiology Research, Institute of Molecular Medicine, University of Southern Denmark, Odense 5000, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kruuse', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}]",Brain communications,['10.1093/braincomms/fcaa020']
3217,33033844,Evaluation of a new face mask concept for oxygen administration: a crossover study in healthy volunteers.,"We developed a new face mask concept for oxygen administration using non-woven textiles. The aim of this study was to evaluate whether the new mask improves acceptability without compromising O 2  delivery and CO 2  elimination. 10 healthy adult volunteers were randomized to either the conventional plastic face mask-first group or the new face mask-first group. Participants were asked to wear the assigned mask with O 2  at 3 L/min for 10 min while seated. End tidal O 2  concentration (et-O 2 ) and end tidal CO 2  concentration (et-CO 2 ) were measured via a sampling tube located at the mouth. After a 10-min rest period, the other mask was tested in the same manner. Mask discomfort was evaluated using a 100 mm visual analog scale (VAS) where 0, comfortable and 100, uncomfortable. The results showed that use of the new mask caused less discomfort than the conventional mask (new, 11; conventional, 33) (P = 0.002). Median et-O 2  with the new mask was 33%, compared with 30% with the conventional mask (P = 0.008). There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg). In conclusion, the new mask was more comfortable and provided higher et-O 2  than the conventional mask.",2020,"There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg).","['10 healthy adult volunteers', 'healthy volunteers']",['conventional plastic face mask-first group or the new face mask-first group'],"['End tidal O 2  concentration (et-O 2 ) and end tidal CO 2  concentration (et-CO 2 ', 'discomfort', 'Mask discomfort']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",10.0,0.0231405,"There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. kondo320@hiroshima-u.ac.jp.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Saeki', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Otsuki', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02861-0']
3218,33033846,Self-reduction techniques taught via smartphone are effective for anterior shoulder dislocation: prospective randomized study.,"PURPOSE


To prospectively compare the effectiveness of three methods for self-assisted shoulder reduction demonstrated using a smartphone video link.
BACKGROUND


Anterior shoulder dislocation is very common among young adults. Patients often seek medical assistance in the emergency department to reduce their shoulder. Many techniques for shoulder reduction had been described, some of which do not require professional assistance and can be performed by patients themselves.
METHODS


Patients admitted with anterior shoulder dislocation were randomized to either the Stimson, Milch or the Boss-Holtzach-Matter technique. Each patient was given a link to watch a short instructional video on his smartphone and instructed to attempt self-reduction. Success of the reduction, pain level, patient satisfaction and complications were recorded.
RESULTS


The study cohort consisted of 58 patients (mean age was 31.6 (18-66, median = 27), 82% males, 88% right hand dominant). Success rate using Boss-Holtzach-Matter (10 of 19, 53%) and self-assisted Milch (11 of 20, 55%) were significantly higher than with the self-assisted Stimson method (3 of 19, 16%), p < 0.05. Pain levels improved from 8.4 (2-10) to 3.1 (0-10) following the reduction. Patient subjective satisfaction from the reduction attempt was 6.7 (0-10). No complications were observed.
CONCLUSION


Both the Self-assisted Milch and the Boss-Holtzach-Matter techniques are ideal for reduction of anterior shoulder dislocation without medical assistance. Both methods can be successfully performed without assistance or previous education and taught using an instructional video.
LEVEL OF EVIDENCE


Level II.",2020,Pain levels improved from 8.4 (2-10) to 3.1 (0-10) following the reduction.,"['Patients admitted with anterior shoulder dislocation', 'anterior shoulder dislocation', 'young adults', '58 patients (mean age was 31.6 (18-66, median\u2009=\u200927']","['Stimson, Milch or the Boss-Holtzach-Matter technique', 'smartphone video link', 'Self-reduction techniques taught via smartphone']","['Patient subjective satisfaction', 'Pain levels', 'self-assisted Milch', 'Success rate', 'reduction, pain level, patient satisfaction and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0347738', 'cui_str': 'Anterior dislocation of shoulder joint'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0575266,Pain levels improved from 8.4 (2-10) to 3.1 (0-10) following the reduction.,"[{'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Chechik', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Maman', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Efi', 'Initials': 'E', 'LastName': 'Kazum', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Grunstein', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Dvir', 'Initials': 'D', 'LastName': 'Ben-Shabat', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Efrima', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Factor', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Rotman', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Krespi', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Dolkart', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel. dolkarto@gmail.com.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Rosenthal', 'Affiliation': 'Shoulder Unit, Division of Orthopaedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, 6423906, Tel Aviv, Israel.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06310-z']
3219,33033863,Radiomics using CT images for preoperative prediction of futile resection in intrahepatic cholangiocarcinoma.,"OBJECTIVES


To investigate and compare radiomics and clinical information for preoperative prediction of futile resection in intrahepatic cholangiocarcinoma (ICC).
METHODS


A total of 203 ICC patients from two centers were included and randomly allocated with a ratio of 7:3 into the training cohort and the validation cohort. Clinical characteristics and radiomics features were selected using random forest algorithm and logistic models to construct a clinical model and a radiomics model, respectively. A combined logistic model that incorporated the developed radiomics signature and clinical risk factors was then built. The performance of these models was evaluated and compared by plotting the receiver operating characteristic (ROC) curve and calculating the area under the curve (AUC).
RESULTS


The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC. The radiomics model reached a sensitivity of 0.846 (95% CI: 0.546, 0.981) and a specificity of 0.771 (95% CI: 0.627, 0.880) in the validation cohort. Moreover, the radiomics model had comparable AUCs with the combined model in training and validation cohorts.
CONCLUSIONS


We presented an internally validated radiomics model for the prediction of futile resection in ICC patients. Compared with clinical information, radiomics using CT images had greater potential for predicting futile resection accurately before surgery.
KEY POINTS


• Radiomics model using CT images could predict futile resection in intrahepatic cholangiocarcinoma preoperatively. • Radiomics model using CT images was superior to clinical information for predicting futile resection accurately before surgery.",2020,"The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC.","['203 ICC patients from two centers', 'ICC patients']",[],['receiver operating characteristic (ROC) curve and calculating the area under the curve (AUC'],"[{'cui': 'C0345905', 'cui_str': 'Intrahepatic bile duct carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",203.0,0.0356687,"The radiomics model showed a higher AUC than the clinical model in the validation cohort (AUC: 0.804 (95% CI: 0.697, 0.912) vs. 0.590 (95% CI: 0.415, 0.765), p = 0.043) for predicting futile resection in ICC.","[{'ForeName': 'Hongpeng', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zelong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhong Shan Road 2, Guangzhou, 510080, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Radiology, The Zhu Jiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lei', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shuling', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhong Shan Road 2, Guangzhou, 510080, China.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'Clinical Trial Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. pengsui@vip.163.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Kuang', 'Affiliation': 'Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. kuangminda@hotmail.com.'}]",European radiology,['10.1007/s00330-020-07250-5']
3220,33033956,Impact of aerosol box on intubation during COVID-19: a simulation study of normal and difficult airways.,"PURPOSE


Patients with coronavirus disease (COVID-19) are at risk of requiring mechanical ventilation, and concerns of protecting healthcare workers during aerosol-generating medical procedures has led to the design of the aerosol box.
METHODS


We conducted a randomized crossover mannequin-based simulation study to compare airway management with and without the aerosol box. Thirty-five anesthesiology participants and three critical care participants with more than 50 intubations with videolaryngoscopes were recruited. There were four airway simulations with and without the aerosol box (normal, pharyngeal swelling, cervical spine rigidity, and tongue edema). Each participant intubated the mannequin in eight consecutive simulations. The primary outcome of the study was time to intubation. Secondary outcomes included intubation attempts, optimization maneuvers, and personal protective equipment breaches.
RESULTS


Mean (standard deviation [SD]) time to intubation overall with the box was 30.9 (23.0) sec, while the time to intubation without the box was 25.1 (12.2) sec (mean difference, 5.8; 95% confidence interval [CI], -2.9 to 14.5). For the normal airway scenario, the mean (SD) time to intubation was 18.6 (3.5) sec for no box and 20.4 (3.3) sec for box (mean difference, 1.8; 95% CI, 0.2 to 3.4). During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7). There were more intubation attempts, personal protective equipment breaches, and optimization maneuvers during use of the aerosol box.
CONCLUSIONS


In this mannequin-based simulation study, the use of the aerosol box increased the time to intubation in some contexts but not others. Further studies in a clinical setting should be conducted to make appropriate modifications to the aerosol box to fully elicit its efficacy and safety prior to implementation in airway guidelines for managing patients with COVID-19.",2020,"During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7).","['Thirty-five anesthesiology participants and three critical care participants with more than 50 intubations with videolaryngoscopes were recruited', 'Patients with coronavirus disease (COVID-19']",['aerosol box'],"['aerosol box (normal, pharyngeal swelling, cervical spine rigidity, and tongue edema', 'mean (SD) time to intubation', 'time to intubation', 'intubation attempts, optimization maneuvers, and personal protective equipment breaches', 'Mean (standard deviation [SD]) time to intubation overall with the box', 'time to intubation without the box']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]","[{'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0151610', 'cui_str': 'Edema of the tongue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",35.0,0.0671134,"During difficult airway scenarios only, the time to intubation was 34.4 (25.6) sec with the aerosol box and 27.3 (13.2) sec without the aerosol box (mean difference, 7.1; 95% CI, -2.5 to 16.7).","[{'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Fong', 'Affiliation': 'Department of Anesthesia & Pain Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada. sfong1@ualberta.ca.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Faculty of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Efrem', 'Initials': 'E', 'LastName': 'Violato', 'Affiliation': 'Department of Educational Psychology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesia & Pain Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01825-y']
3221,33033996,Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial.,"We evaluated the effect of an option B-plus Enhanced Adherence Package (BEAP), on early ART uptake in a randomized controlled trial. HIV-positive, ART naïve pregnant women in Lusaka, Zambia, were randomized to receive BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC). The primary outcome was initiating and remaining on ART at 30 days. Analysis was by intention to treat (ITT) using logistic regression. Additional per protocol analysis was done. We enrolled 454 women; 229 randomized to BEAP and 225 to SOC. Within 30 days of eligibility, 445 (98.2%) initiated ART. In ITT analysis, 82.5% BEAP versus 80.4% SOC participants reached primary outcome (crude relative risk [RR] 1.03; 95% confidence interval [CI] 0.91-1.16; Wald test statistic = 0.44; p-value = 0.66). In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03). Early ART initiation in pregnancy was nearly universal but there was early drop out suggesting need for additional adherence support.This trial was registered at ClinicalTrials.gov (trials number NCT02459678) on May 14, 2015.",2020,"In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03).","['We enrolled 454 women; 229 randomized to BEAP and 225 to SOC', 'HIV-Positive Pregnant Women in Zambia', 'HIV-positive, ART naïve pregnant women in Lusaka, Zambia']","['BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC', 'option B-plus Enhanced Adherence Package (BEAP', 'Enhanced Adherence Package']",[],"[{'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],454.0,0.626768,"In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03).","[{'ForeName': 'Mwangelwa', 'Initials': 'M', 'LastName': 'Mubiana-Mbewe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bosomprah', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Kadota', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Aybüke', 'Initials': 'A', 'LastName': 'Koyuncu', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Thankian', 'Initials': 'T', 'LastName': 'Kusanathan', 'Affiliation': 'Department of Gender Studies, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Mweebo', 'Affiliation': 'Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.'}, {'ForeName': 'Kebby', 'Initials': 'K', 'LastName': 'Musokotwane', 'Affiliation': 'Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.'}, {'ForeName': 'Priscilla L', 'Initials': 'PL', 'LastName': 'Mulenga', 'Affiliation': 'Directorate of Public Health, Zambian Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vinikoor', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}]",AIDS and behavior,['10.1007/s10461-020-03060-4']
3222,33034015,Outcomes with Intra-gastric Balloon Therapy in BMI < 35 Non-morbid Obesity: 10-Year Follow-Up Study of an RCT.,"PURPOSE


Intra-gastric balloon (IGB) therapy is the most established endoscopic treatment of obesity, but there is a paucity of literature on long-term efficacy. This study aims to evaluate the short- and long-term weight loss efficacy of IGB.
MATERIALS AND METHODS


Double-blinded RCT with 6-month IGB vs with sham endoscopy, in body mass index (BMI) 27-35 patients. Anthropometric, fasting glucose, and lipid profile measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention.
RESULTS


Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05), 18 (5.42 vs 3.57, p = 0.32), and 24 months (4.07 vs 2.93 kg, p = 0.56) favored the IGB group. Total weight loss (TWL) at 10 years (0.03 vs - 2.32 kg, p = 0.05) and %TWL (- 0.16 ± 12.8% vs - 2.84 ± 5.6%, p = 0.39) were not significantly different between groups. Follow-up BMI (30.97 ± 1.6 vs 30.38 ± 1.8 kg/m 2 , p = 1.00) was similar. At 10 years, new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia were not significant (p > 0.05). Twenty-three (81%) IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01).
CONCLUSION


IGB delivers weight loss to 2 years and is superior to control. However, new comorbidity development is not significantly different at 10 years. Patient that received IGB therapy were subsequently more willing for further bariatric metabolic intervention.",2020,"IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01).
","['Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6', 'BMI <\u200935 Non-morbid Obesity']","['IGB therapy', 'IGB', 'Intra-gastric Balloon Therapy', 'gastric balloon (IGB) therapy']","['Total weight loss (TWL', 'new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia', 'total body weight loss (kg) and BMI', 'new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention', 'Anthropometric, fasting glucose, and lipid profile measurement', 'Total body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0017124', 'cui_str': 'Gastric balloon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0017124', 'cui_str': 'Gastric balloon'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",99.0,0.054543,"IGB group vs 13 (56%) control expressed a willingness for further intervention (p < 0.01).
","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Chan', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Josil R', 'Initials': 'JR', 'LastName': 'Cruz', 'Affiliation': 'Department of Surgery, Southern Philippines Medical Center, Davao City, Philippines.'}, {'ForeName': 'Wilfred L', 'Initials': 'WL', 'LastName': 'Mui', 'Affiliation': 'Hong Kong Bariatric and Metabolic Institute, Hong Kong, Hong Kong.'}, {'ForeName': 'Simon K H', 'Initials': 'SKH', 'LastName': 'Wong', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Enders K W', 'Initials': 'EKW', 'LastName': 'Ng', 'Affiliation': 'Division of Upper Gastrointestinal & Metabolic Surgery, Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong. endersng@surgery.cuhk.edu.hk.'}]",Obesity surgery,['10.1007/s11695-020-04986-3']
3223,33034159,Utility of an Observational Social Skill Assessment as a Measure of Social Cognition in Autism.,"Models of impaired social competence in autism spectrum disorder (ASD) highlight deficits in social cognition and social behavior. The Contextual Assessment of Social Skills (CASS) is a laboratory-based assessment of conversation ability in which participants interact with trained confederates who act interested (CASS-I) and bored (CASS-B), sequentially. The increased ecological validity of the CASS allows for better generalization to real-world social situations. Participants' perceptions of confederate behavior, assessed by the CASS Conversation Rating Scale (CRS), might offer additional utility as a metric of social cognition. The current study examined CASS confederate behavior (adherence to interested or bored condition) and both internal validity and convergent validity of the CASS as a measure of social behavior and social cognition. Fifty adolescents with ASD participated as part of a multisite randomized clinical trial. Adherence ratings were consistent across gender and site, with interested confederates significantly out-performing bored confederates. The ability to distinguish between interested and bored confederates was positively associated with CASS social behavior and social cognition tasks, although social behavior during the CASS was not consistently associated with parent-rated social behavior. Controlling for confederate behavior did not significantly alter these associations. Findings demonstrate strong internal validity of the CASS and, partially, external validity of the CASS as a measure of social cognition. Findings highlight nuanced differences in social behavior and social cognition. The CASS shows promise as an outcome measure for clinical interventions and should be incorporated into a multimethod battery to assess social competence in individuals with ASD. LAY SUMMARY: Social cognition and social behavior should be studied together to examine social competence in youth with autism. The Contextual Assessment of Social Skills (CASS), a behavioral observation measure, shows promise toward this end; findings suggest the CASS taps social cognition and social behavior when administered alongside a participant rating scale of their conversation partner's engagement. Continued research, including examination of the CASS, may inform best practices in comprehensive assessment of social competence in autism.",2020,"The ability to distinguish between interested and bored confederates was positively associated with CASS social behavior and social cognition tasks, although social behavior during the CASS was not consistently associated with parent-rated social behavior.","['autism spectrum disorder (ASD', 'Fifty adolescents with ASD', 'Autism', 'youth with autism', 'participants interact with trained confederates who act interested (CASS-I) and bored (CASS-B), sequentially', 'individuals with ASD']","['CASS', 'Contextual Assessment of Social Skills (CASS']","['Contextual Assessment of Social Skills (CASS', 'Adherence ratings', 'social behavior and social cognition', 'CASS Conversation Rating Scale (CRS', 'CASS social behavior and social cognition tasks', 'ecological validity', 'CASS taps social cognition and social behavior']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C2945608', 'cui_str': 'Bore'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]",50.0,0.015368,"The ability to distinguish between interested and bored confederates was positively associated with CASS social behavior and social cognition tasks, although social behavior during the CASS was not consistently associated with parent-rated social behavior.","[{'ForeName': 'Grace Lee', 'Initials': 'GL', 'LastName': 'Simmons', 'Affiliation': 'Department of Psychology, Center for Youth Development and Intervention, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ioannou', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jessica V', 'Initials': 'JV', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Center for Youth Development and Intervention, The University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Blythe A', 'Initials': 'BA', 'LastName': 'Corbett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Lerner', 'Affiliation': 'Clinical Psychology, Department of Psychology, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Department of Psychology, Center for Youth Development and Intervention, The University of Alabama, Tuscaloosa, Alabama, USA.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2404']
3224,33034301,Effect of Umbilical Cord Milking vs Delayed Cord Clamping on Venous Hematocrit at 48 Hours in Late Preterm and Term Neonates: A Randomized Controlled Trial.,"OBJECTIVE


To compare the effect of intact umbilical cord milking (MUC) and delayed cord clamping (DCC) on venous hematocrit at 48 (±6) hours in late preterm and term neonates (350/7- 426/7 wk).
STUDY DESIGN


Randomized trial.
SETTING AND PARTICIPANTS


All late preterm and term neonates (350/7 - 426/7 wk) neonates born in the labor room and maternity operation theatre of tertiary care unit were included.
INTERVENTION


We randomly allocated enrolled neonates to MUC group (cord milked four times towards the baby while being attached to the placenta; n=72) or DCC group (cord clamped after 60 seconds; n=72).
OUTCOME


Primary outcome was venous hematocrit at 48 ((±6) hours of life. Additional outcomes were venous hematocrit at 48 ((±6) hours in newborns delivered through lower segment caesarean section (LSCS), incidence of polycythemia requiring partial exchange transfusion, incidence of hyperbilirubinemia requiring phototherapy, and venous hematocrit and serum ferritin levels at 6 (±1) weeks of age.
RESULTS


The mean (SD) hematocrit at 48 ((±6) hours in the MUC group was higher than in DCC group [57.7 (4.3) vs. 55.9 (4.4); P=0.002]. Venous hematocrit at 6 ((±1) weeks was higher in MUC than in DCC group [mean (SD), 37.7 (4.3) vs. 36 (3.4); mean difference 1.75 (95% CI 0.53 to 2.9); P=0.005]. Other parameters were similar in the two groups.
CONCLUSIONS


MUC leads to a higher venous hematocrit at 48 (±6) hours in late preterm and term neonates when compared with DCC.",2020,mean difference 1.75 (95% CI 0.53 to 2.9); P=0.005].,"['venous hematocrit at 48 (±6) hours in late preterm and term neonates (350/7- 426/7 wk', 'All late preterm and term neonates (350/7 - 426/7 wk) neonates born in the labor room and maternity operation theatre of tertiary care unit were included', 'at 48 Hours in Late Preterm and Term Neonates']","['Umbilical Cord Milking vs Delayed Cord Clamping', 'intact umbilical cord milking (MUC) and delayed cord clamping (DCC', 'MUC group (cord milked four times towards the baby while being attached to the placenta; n=72) or DCC']","['mean (SD) hematocrit', 'venous hematocrit at 48 ((±6) hours in newborns delivered through lower segment caesarean section (LSCS), incidence of polycythemia requiring partial exchange transfusion, incidence of hyperbilirubinemia requiring phototherapy, and venous hematocrit and serum ferritin levels', 'Venous Hematocrit', 'Venous hematocrit', 'venous hematocrit at 48 ((±6) hours of life']","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032461', 'cui_str': 'Polycythaemia'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0015236', 'cui_str': 'Exchange transfusion'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.278978,mean difference 1.75 (95% CI 0.53 to 2.9); P=0.005].,"[{'ForeName': 'Mukul Kumar', 'Initials': 'MK', 'LastName': 'Mangla', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Anu Thukral, Assistant Professor, Department of Pediatrics, Newborn Health and Knowledge Centre, First floor, New private ward, AIIMS, New Delhi 110 029, India. dranuthukral@gmail.com.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Deorari', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'Division of Neonatology, Department of Paediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian pediatrics,[]
3225,33034357,Cross-sectional Study on Corneal Denervation in Contralateral Eyes Following SMILE Versus LASIK.,"PURPOSE


To compare long-term corneal nerve status following small incision lenticule extraction (SMILE) versus laser in situ keratomileusis (LASIK).
METHODS


Twenty-four patients were randomized to receive SMILE in one eye and LASIK in the other eye. In vivo confocal microscopy examination and dry eye assessments were performed at a mean of 4.1 years postoperatively. The patients were further divided into two groups based on the mean assessment time: 2.7 years postoperatively (2.7 years group) and 5.5 years postoperatively (5.5 years group). Another 6 age-matched normal patients were recruited.
RESULTS


At 4.1 years, LASIK eyes had significantly less corneal nerve fiber density (CNFD), corneal nerve branch density (CNBD), corneal nerve fiber length (CNFL), and corneal total branch density and significantly more nerves with beading than SMILE eyes. The CNFD, CNBD, CNFL, and number of nerves with sprouting were significantly higher in the 5.5 years group than in the 2.7 years group, in both types of surgery, suggesting persistent nerve regeneration. The CNBD and CNFD in the 5.5 years group, regardless of surgical types, were significantly lower than those in the control group, indicating the nerve status had not recovered to normal ranges even at 5.5 years. High myopic treatment resulted in significantly reduced CNFD with LASIK but not with SMILE. There were no significant differences in the dry eye parameters between the two procedures at 4.1 years postoperatively.
CONCLUSIONS


The impact on corneal nerves following refractive surgery is long-lasting. SMILE had better nerve preservation and regeneration than LASIK, but neither procedure had recovered nerve status to normal levels even at 5.5 years. [J Refract Surg. 2020;36(10):653-660.].",2020,"There were no significant differences in the dry eye parameters between the two procedures at 4.1 years postoperatively.
","['Another 6 age-matched normal patients were recruited', 'Twenty-four patients']","['SMILE in one eye and LASIK', 'small incision lenticule extraction (SMILE) versus laser in situ keratomileusis (LASIK', 'SMILE Versus LASIK']","['dry eye parameters', 'CNBD and CNFD', 'CNFD, CNBD, CNFL, and number of nerves with sprouting', 'corneal nerve fiber density (CNFD), corneal nerve branch density (CNBD), corneal nerve fiber length (CNFL), and corneal total branch density', 'CNFD with LASIK', 'nerve preservation and regeneration']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}]",24.0,0.0240706,"There were no significant differences in the dry eye parameters between the two procedures at 4.1 years postoperatively.
","[{'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Angel Se Ji', 'Initials': 'ASJ', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Jia Ying', 'Initials': 'JY', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Lily Wei Yun', 'Initials': 'LWY', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20200730-01']
3226,33034360,Early Corneal and Epithelial Remodeling Differences Identified by OCT Imaging and Artificial Intelligence Between Two Transepithelial PRK Platforms.,"PURPOSE


To analyze corneal and epithelial remodeling differences between SmartSurfACE reverse transepithelial PRK (SCHWIND eye-tech-solutions) and Streamlight (Alcon Laboratories, Inc) transepithelial PRK procedure using optical coherence tomography (OCT) and artificial intelligence (AI).
METHODS


This was a prospective, interventional, and longitudinal study. A contralateral eye study was conducted in which one eye was assigned to the SmartSurfACE group and the fellow eye was assigned to the Streamlight group. OCT was performed preoperatively and 1, 3, and 6 months after surgery. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity and residual refractive error was measured only preoperatively and at 3 and 6 months. From OCT, curvature and aberrations of the air-epithelium (A-E) interface, epithelium-Bowman's layer (E-B) interface, and epithelium Zernike indices (EZI) were derived. Pain was evaluated at 1 day postoperatively using the Wong-Baker scale.
RESULTS


Both groups had similar UDVA, CDVA, residual refractive error, and changes in A-E and E-B curvatures at 3 and 6 months postoperatively (P > .05). However, many parameters indicated that the Streamlight group underwent a greater change in A-E aberrations, E-B aberrations, and EZI than the SmartSurfACE group postoperatively (P < .05). The EZI indicated a greater level of epithelial thickness distortion in the Streamlight group than in the SmartSurfACE group (P < .05). Using AI, the EZI were most indicative of remodeling differences between the two groups. Further, the pain was significantly greater at 1 day in the Streamlight group (P < .05).
CONCLUSIONS


Early remodeling differences existed because the Streamlight procedure removed a greater amount of epithelium than the SmartSurfACE procedure. However, the visual and refractive outcomes were comparable. [J Refract Surg. 2020;36(10):678-686.].",2020,"Further, the pain was significantly greater at 1 day in the Streamlight group (P < .05).
",[],"['SmartSurfACE', 'OCT Imaging and Artificial Intelligence']","['A-E aberrations, E-B aberrations, and EZI', ""From OCT, curvature and aberrations of the air-epithelium (A-E) interface, epithelium-Bowman's layer (E-B) interface, and epithelium Zernike indices (EZI"", 'level of epithelial thickness distortion', 'Pain', 'Uncorrected (UDVA) and corrected (CDVA) distance visual acuity and residual refractive error', 'similar UDVA, CDVA, residual refractive error, and changes in A-E and E-B curvatures', 'pain']",[],"[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0229127', 'cui_str': 'Anterior limiting lamina of cornea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0248954,"Further, the pain was significantly greater at 1 day in the Streamlight group (P < .05).
","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Shetty', 'Affiliation': ''}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Narasimhan', 'Affiliation': ''}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Dadachanji', 'Affiliation': ''}, {'ForeName': 'Pavitra', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Maheshwari', 'Affiliation': ''}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Chabra', 'Affiliation': ''}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Sinha Roy', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20200730-03']
3227,33038087,Single-center randomized trial comparing conventional chemoembolization versus doxorubicin-loaded polyethylene glycol microspheres for early- and intermediate-stage hepatocellular carcinoma.,"According to Barcelona Clinic Liver Cancer classification, transarterial chemoembolization (TACE) is preferred treatment for stage B and in certain cases for stage A hepatocellular carcinoma (HCC). Conventional TACE (c-TACE) and drug-eluting microspheres TACE (DEM-TACE) are available intraarterial therapies. Screening of patients with cirrhosis is of great importance for early detection of malignant liver nodules. Primary endpoint of this study was to compare DEM-TACE with c-TACE in terms of 12- and 24-month survival. Secondary endpoints were comparison of intensity and duration of the postembolization syndrome (PES) and severe adverse events. We randomized 60 patients with unresectable HCC one-to-one with c-TACE or DEM-TACE and followed them for at least 24 months or until death. TACE was repeated 'on-demand. Most patients underwent two TACE sessions and the median hospital stay was 3 days for c-TACE and 2 days for DEM-TACE group. The overall 12- and 24-month survival rates were 89.8 and 70.7%, respectively, precisely 85.7 and 63.6% after c-TACE and 90.2 and 75.8% after DEM-TACE, without any significant difference (P = 0.18). Median overall survival was 21.1 months. Significant difference in the overall 12- and 24-month survival was found in patients with Child-Pugh A compared to Child-Pugh B class (P = 0.001). Child-Pugh class, aspartate aminotransferase levels and ascites independently predicted survival (P = 0.003). Both, DEM-TACE and c-TACE showed excellent 12- and 24-month survival rates. No significant difference in terms of adverse events was found. PES was slightly more severe after c-TACE, because of elevated temperature. DEM-TACE requires shorter in-hospital stay.",2020,Significant difference in the overall 12- and 24-month survival was found in patients with Child-Pugh A compared to Child-Pugh B class (P = 0.001).,"['60 patients with unresectable HCC one-to-one with c-TACE or DEM-TACE and followed them for at least 24 months or until death', 'early- and intermediate-stage hepatocellular carcinoma', 'patients with cirrhosis']","['DEM-TACE', 'TACE', 'conventional chemoembolization versus doxorubicin-loaded polyethylene glycol microspheres', 'transarterial chemoembolization (TACE', 'Conventional TACE (c-TACE) and drug-eluting microspheres TACE (DEM-TACE']","['comparison of intensity and duration of the postembolization syndrome (PES) and severe adverse events', 'overall 12- and 24-month survival rates', 'median hospital stay', 'Pugh class, aspartate aminotransferase levels and ascites independently predicted survival', 'adverse events', 'Median overall survival', '24-month survival rates', 'overall 12- and 24-month survival', 'DEM-TACE with c-TACE in terms of 12- and 24-month survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",60.0,0.0251758,Significant difference in the overall 12- and 24-month survival was found in patients with Child-Pugh A compared to Child-Pugh B class (P = 0.001).,"[{'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Gjoreski', 'Affiliation': 'Department of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Jovanoska', 'Affiliation': 'Department of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Risteski', 'Affiliation': 'Department of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Prgova Veljanova', 'Affiliation': 'Department of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Nedelkovski', 'Affiliation': 'Department of Abdominal Surgery, City General Hospital ""8th September"".'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Dimov', 'Affiliation': 'Department of Digestive Surgery, Acibadem Sistina Hospital.'}, {'ForeName': 'Rozalinda', 'Initials': 'R', 'LastName': 'Popova Jovanovska', 'Affiliation': 'University Clinic of Gastroenterohepatology.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Grozdanovska Angelovska', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, ""St. Cyril and Methodius"" University.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Mitrevski', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, ""St. Cyril and Methodius"" University.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Dimova', 'Affiliation': 'Department of Pathology, Acibadem Sistina Hospital, Skopje, North Macedonia.'}]",European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP),['10.1097/CEJ.0000000000000623']
3228,33038096,Bone Marrow Reconversion With Reambulation: A Prospective Clinical Trial.,"Marrow adipose tissue may be modulated by physical activity and reambulation after inactivity. The aim of this study was to measure the effect of reambulation for up to 2 years after 60 days of bed rest on the lumbar bone marrow composition.
METHODS


In a prospective clinical trial, 20 healthy men participated in a 60-day, 6-degree head-down tilt bed rest study. Serial 3-T magnetic resonance (MR) imaging measures of the lumbar spine were performed at baseline, after 57 days of bed rest, and at 30, 360, and 720 days of reambulation (100 MR imaging scans). Proton density with and without fat saturation, 2-point Dixon, and single-voxel MR spectroscopy techniques were used to assess bone marrow composition (300 measures). Erythropoiesis was measured using hematocrit, reticulocyte, and ferritin. Also, participants randomly received either a nutritional intervention composed of polyphenols, omega-3, vitamin E, and selenium or a normal diet.
RESULTS


Thirty days of reambulation after 60 days of bed rest caused a marked decrease of the mean lumbar vertebral fat fraction (VFF) (-9.2 ± 1.6 percentage points, -8.0 ± 1.3 percentage points, and -12.7 ± 1.2 percentage points compared with baseline using proton density, Dixon, MR spectroscopy, respectively; all 3, P < 0.05). Reambulation also decreased the fat saturation index (-5.3 ± 1.1 percentage points compared with baseline; P < 0.05). These coincided with lower hematocrit and ferritin and with increased reticulocytes at reambulation day 13 compared with baseline (all 3, P < 0.05). After 57 days of bed rest, the VFF was unchanged from baseline (all 3 MR techniques, P > 0.05); reambulation for 2 years returned the lumbar VFF to baseline values.
INTERPRETATION


This longitudinal trial established that 30 days of reambulation after 60 days of bed rest constituted a powerful stimulus for bone marrow reconversion. In this model, the enhanced erythropoiesis coupled with preferential consumption of fatty acids from regulated marrow adipose tissue to supply energy for erythropoiesis and bone anabolism may explain the lumbar vertebrae reconversion. These results will help interpreting bone marrow signal in ambulatory patients after long periods of bed rest.",2020,"Thirty days of reambulation after 60 days of bed rest caused a marked decrease of the mean lumbar vertebral fat fraction (VFF) (-9.2 ± 1.6 percentage points, -8.0 ± 1.3 percentage points, and -12.7 ± 1.2 percentage points compared with baseline using proton density, Dixon, MR spectroscopy, respectively; all 3, P < 0.05).","['20 healthy men participated in a 60-day, 6-degree head-down tilt bed rest study']","['nutritional intervention composed of polyphenols, omega-3, vitamin E, and selenium or a normal diet', 'Bone Marrow Reconversion With Reambulation', 'Proton density with and without fat saturation, 2-point Dixon, and single-voxel MR spectroscopy techniques']","['VFF', 'Erythropoiesis', 'fat saturation index', 'bone marrow composition', 'hematocrit and ferritin and with increased reticulocytes', 'mean lumbar vertebral fat fraction (VFF', 'hematocrit, reticulocyte, and ferritin']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0206160', 'cui_str': 'Reticulocytosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0035286', 'cui_str': 'Reticulocyte'}]",20.0,0.0568151,"Thirty days of reambulation after 60 days of bed rest caused a marked decrease of the mean lumbar vertebral fat fraction (VFF) (-9.2 ± 1.6 percentage points, -8.0 ± 1.3 percentage points, and -12.7 ± 1.2 percentage points compared with baseline using proton density, Dixon, MR spectroscopy, respectively; all 3, P < 0.05).","[{'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'From the Bone and Joint Research Laboratory, Division of Physical Medicine and Rehabilitation, Department of Medicine, Ottawa Hospital Research Institute.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Melkus', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'School of Epidemiology and Public Health.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Laneuville', 'Affiliation': 'Department of Biology.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Trudel', 'Affiliation': 'From the Bone and Joint Research Laboratory, Division of Physical Medicine and Rehabilitation, Department of Medicine, Ottawa Hospital Research Institute.'}]",Investigative radiology,['10.1097/RLI.0000000000000730']
3229,33038141,Does age at the start of treatment for vaginal atrophy predict response to vaginal estrogen therapy? Post hoc analysis of data from a randomized clinical trial involving 205 women treated with 10 μg estradiol vaginal tablets.,"OBJECTIVE


Local estrogen therapy (ET) can improve vaginal atrophy symptoms and associated cellular changes in postmenopausal women. This study evaluated whether age at the start of treatment influences response.
METHODS


This post hoc analysis used data from a double-blind, randomized, placebo-controlled trial (NCT00108849), which treated 205 postmenopausal women aged ≥45 years with 10 μg vaginal ET for 52 weeks.Women aged <60 or ≥60 years at treatment start were evaluated according to the following: vaginal maturation index (assessed by vaginal cytology samples), vaginal pH, and most bothersome symptom (both graded on four-point scales). Covariance analysis aimed to evaluate mean change differences between groups from baseline-week 52.
RESULTS


Vaginal ET improved vaginal maturation index (for all cell layers), vaginal pH, and symptom scores for both age groups. However, cytological profiles were significantly different in the <60 (n = 143) versus ≥60 years group (n = 55, estimated effect: -3.7, P = 0.0003 [parabasal cells]; 5.8, P = 0.0002 [intermediate cells]), indicating reduced cellular responsiveness to treatment among older women. Treatment effect on vaginal pH was less for older women, with a between-group difference of -0.19 (standard error = 0.05; P = 0.0003).
CONCLUSIONS


Findings suggest that treatment may be initiated at any age since low-dose vaginal ET improved symptoms and signs of vaginal atrophy in both younger (<60 years) and older (≥60 y) women. The stronger response observed in younger women supports current clinical recommendations to start treatment early. Continued treatment may be important to avoid recurrence of vaginal atrophy. : Video Summary:http://links.lww.com/MENO/A653.",2020,"RESULTS


Vaginal ET improved vaginal maturation index (for all cell layers), vaginal pH, and symptom scores for both age groups.","['younger (<60 years) and older (≥60 y) women', '205 postmenopausal women aged ≥45 years with 10\u200aμg vaginal ET for 52 weeks', '205 women treated with 10\u200aμg estradiol vaginal tablets', 'postmenopausal women', 'Women aged\u200a<60 or ≥60 years at treatment start were evaluated according to the following: vaginal maturation index (assessed by vaginal cytology samples), vaginal pH, and most bothersome symptom (both graded on four-point scales']","['placebo', 'Local estrogen therapy (ET', ' Video Summary:http://links.lww.com/MENO/A653']","['cytological profiles', 'vaginal pH', 'symptoms and signs of vaginal atrophy', 'vaginal maturation index (for all cell layers), vaginal pH, and symptom scores', 'vaginal atrophy symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4529460', 'cui_str': 'Estradiol Vaginal Insert'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0225355', 'cui_str': 'Cytologic material'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",205.0,0.325392,"RESULTS


Vaginal ET improved vaginal maturation index (for all cell layers), vaginal pH, and symptom scores for both age groups.","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Derzko', 'Affiliation': ""University of Toronto St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Röhrich', 'Affiliation': 'Novo Nordisk Health Care AG, Zurich, Switzerland.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Panay', 'Affiliation': ""Queen Charlotte's & Chelsea and Chelsea & Westminster Hospitals and Imperial College London, London, United Kingdom.""}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001666']
3230,33038157,"Cool Cross-Linking: Riboflavin at 4°C for Pain Management After Cross-Linking for Patients with Keratoconus, a Randomized Clinical Trial.","PURPOSE


To explore corneal cooling as a method of pain management in corneal-accelerated collagen cross-linking.
METHODS


This was a prospective and interventional randomized clinical trial registered in the National Institutes of Health Clinical Trials through the identifier NCT030760770. The research was conducted at the Institute of Ophthalmology ""Conde de Valenciana."" A total of 98 patients were randomly assigned to one of the following 2 groups: cold riboflavin (4°C) group or control group (riboflavin at room temperature). The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression. The exclusion criteria were patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity that would make the understanding of the pain test difficult. The main outcome measures were pain, tearing, photophobia, foreign body sensation, and irritation.
RESULTS


At 2 hours post-op, pain in the case and control groups was 3.80 ± 3.00 and 8.08 ± 2.21 (P < 0.05), tearing was 1.56 ± 1.96 and 8.29 ± 2.42 (P < 0.05), photophobia was 5.44 ± 3.57 and 7.83 ± 2.64 (P < 0.05), foreign body sensation was 2.20 ± 2.78 and 6.54 ± 2.73 (P < 0.05), and irritation was 3.48 ± 2.98 and 6.79 ± 3.00 (P < 0.05), respectively. A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
CONCLUSIONS


This study demonstrated that pain and associated symptoms decreased significantly in the riboflavin 4°C group.",2020,"A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
","['The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression', '98 patients', 'patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity']","['riboflavin', 'Cool Cross-Linking: Riboflavin', 'cold riboflavin (4°C) group or control group (riboflavin at room temperature']","['photophobia', 'pain and associated symptoms', 'pain values', 'Pain Management', 'pain, tearing, photophobia, foreign body sensation, and irritation', 'foreign body sensation', 'pain']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}]",98.0,0.0767731,"A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Toro-Giraldo', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Morales Flores', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Santana-Cruz', 'Affiliation': 'Department of Optometry, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Ramirez-Miranda', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navas', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Olivo-Payne', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lichtinger', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Jimenez-Corona', 'Affiliation': 'Department of Ocular Epidemiology and Public Health, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Enrique O', 'Initials': 'EO', 'LastName': 'Graue-Hernández', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}]",Cornea,['10.1097/ICO.0000000000002484']
3231,33038320,Effect of restricted retail merchandising of discretionary food and beverages on population diet: a pragmatic randomised controlled trial.,"BACKGROUND


The effectiveness of healthy food promotion on food and beverage sales in real-world food retail settings has been shown in randomised trials. The effectiveness of restrictions on the promotion of unhealthy food is, however, less clear. We aimed to assess the effect of restricted unhealthy food promotion, specifically those items contributing most to free sugar sales, on food and beverage sales.
METHODS


In this community-level pragmatic, partially randomised, parallel group trial, stores were randomly assigned by a statistician using a single sequence of random assignments to the intervention group, in which a co-designed strategy restricted merchandising of unhealthy food, or to a control group of usual retail practice. The trial was done in partnership with an organisation operating 25 stores in remote Australia. The primary analysis was based on difference in weekly sales with the strategy compared with no strategy in free sugar from all foods and beverages (g/total MJ; primary outcome), targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU$) using mixed models. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001588280.
FINDINGS


Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores were randomly assigned to the intervention group and ten stores to the control group. The trial was done between Sept 2 and Dec 2, 2018. The Healthy Stores 2020 strategy resulted in a reduction in sales of free sugar of 2·8% (95% CI -4·9 to -0·7). Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7). Reductions in sales of free sugar from confectionery of 7·5% (-14·3 to -0·2) and in weight sold (-4·6%, -11·1 to 2·3) resulted; however, the reduction in weight was not statistically significant. No differences in sales of table sugar and sweet biscuits were observed. Gross profit was not impacted adversely; a small increase resulted (5·3%, 0·3 to 10·5).
INTERPRETATION


Restricted merchandising of unhealthy foods and beverages, while allowing for complementary merchandising of healthier foods and beverages in a real-world store setting and co-designed with retailers, can achieve both public health and business relevant gains.
FUNDING


Australian National Health and Medical Research Council.",2020,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","['partnership with an organisation operating 25 stores in remote Australia', 'Between June 13 and Aug 15, 2018, 20 stores were recruited; ten stores', 'population diet']",['restricted retail merchandising of discretionary food and beverages'],"['targeted food or beverages (weight and free sugars; g/total MJ), and gross profit (AU', 'Targeted beverages', 'sales of table sugar and sweet biscuits', 'reduction in weight', 'sales of free sugar']","[{'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.138025,"Targeted beverages were reduced by 8·4% (-12·3 to -4·3) and associated free sugar by 6·8% (-10·9 to -2·6), sugar-sweetened soft drinks by 13·2% (-18·5 to -7·6), and associated free sugar by 13·4% (-18·7 to -7·7).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brimblecombe', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Melbourne, VIC, Australia; Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia. Electronic address: julie.brimblecombe@monash.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McMahon', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Ferguson', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Khia', 'Initials': 'K', 'LastName': 'De Silva', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Peeters', 'Affiliation': 'Institute for Health Transformation, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wycherley', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; Alliance for Research in Exercise, Nutrition and Activity, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Leia', 'Initials': 'L', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Greenacre', 'Affiliation': 'Business School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gunther', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chappell', 'Affiliation': 'Arnhem Land Progress Aboriginal Corporation, Darwin, NT, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Menzies School of Health Research, Royal Darwin Hospital Campus, Darwin, NT, Australia; School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Mah', 'Affiliation': 'Faculty of Health, Dalhousie University, Halifax, NS, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",The Lancet. Planetary health,['10.1016/S2542-5196(20)30202-3']
3232,33038338,Influenza Vaccination Blunts the Inflammatory Response in Patients Undergoing Cardiopulmonary Bypass.,"BACKGROUND


Coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) induces an inflammatory reaction that is associated with postoperative complications. Influenza vaccination has been shown to decrease cardiovascular morbidity in patients with cardiovascular disease, possibly via its anti-inflammatory properties. We hypothesize that influenza vaccination would attenuate the inflammatory reaction after CPB.
METHODS


Thirty patients undergoing CABG were blindly randomized to receive the influenza vaccine (group I, N=15) or a placebo (group II, N=15) preoperatively. Serum samples of pro-inflammatory mediators (interleukin-6, interleukin-8, tumor necrosis factor, C-reactive protein) as well as the anti-inflammatory interleukin-10 were collected at different time points perioperatively. Assessment of myocardial dysfunction was investigated by measuring hemodynamic, echocardiographic data and troponin levels. Other clinical outcomes were collected prospectively.
RESULTS


Pro-inflammatory cytokine levels were significantly reduced in the treatment group [interleukin-6 (157.4 pg/dL vs 256 pg/dL,p=0.043), interleukin-8(65.03 pg/dL vs 118.56 pg/dl,p=0.025) and tumor necrosis factor(12.05 pg/dl vs 20.8 pg/dl,p=0.003)]. These differences were observed at the end of CPB and persisted for 2 days postoperatively. Interestingly, the level of the anti-inflammatory marker interleukin-10 was significantly higher in group I (83.3 pg/dl vs 15.15 pg/dl, p=0.008). Evidence of improved myocardial protection was observed in group I as reflected by troponin measurements postoperatively (6020.2 pg/dl vs 12098.01 pg/dl,p=0.052).
CONCLUSIONS


Influenza vaccination attenuates the inflammatory response to CPB as reflected by a reduction in the level of troponin and pro-inflammatory mediators and an increase in the anti-inflammatory cytokine interleukin-10.",2020,"RESULTS


Pro-inflammatory cytokine levels were significantly reduced in the treatment group [interleukin-6 (157.4 pg/dL vs 256 pg/dL,p=0.043), interleukin-8(65.03 pg/dL vs 118.56 pg/dl,p=0.025) and tumor necrosis factor(12.05 pg/dl vs 20.8 pg/dl,p=0.003)].","['Patients Undergoing Cardiopulmonary Bypass', 'patients with cardiovascular disease', 'Thirty patients undergoing CABG']","['Influenza Vaccination', 'placebo', 'Influenza vaccination', 'Coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB', 'influenza vaccine']","['cardiovascular morbidity', 'myocardial dysfunction', 'level of the anti-inflammatory marker interleukin-10', 'level of troponin and pro-inflammatory mediators', 'Pro-inflammatory cytokine levels', 'hemodynamic, echocardiographic data and troponin levels', 'myocardial protection', 'Serum samples of pro-inflammatory mediators (interleukin-6, interleukin-8, tumor necrosis factor, C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",30.0,0.385651,"RESULTS


Pro-inflammatory cytokine levels were significantly reduced in the treatment group [interleukin-6 (157.4 pg/dL vs 256 pg/dL,p=0.043), interleukin-8(65.03 pg/dL vs 118.56 pg/dl,p=0.025) and tumor necrosis factor(12.05 pg/dl vs 20.8 pg/dl,p=0.003)].","[{'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Atoui', 'Affiliation': 'Division of Cardiac Surgery, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada. Electronic address: ratoui@hsnsudbury.ca.'}, {'ForeName': 'Fady Ebrahim', 'Initials': 'FE', 'LastName': 'F', 'Affiliation': ""Department of Anesthesia, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Anesthesia, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Saroka', 'Affiliation': 'Laurentian University, Sudbury, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mireau', 'Affiliation': 'Department of Anesthesia, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'McElhaney', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Hare', 'Affiliation': ""Department of Anesthesia, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.07.052']
3233,33038408,Long-term follow-up of patients with heart failure and reduced ejection receiving autonomic regulation therapy in the ANTHEM-HF pilot study.,"BACKGROUND


The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months.
METHODS


Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months.
RESULTS


Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months.
CONCLUSIONS


In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.",2020,"At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score.","['patients with advanced HF', 'patients with chronic HF with reduced EF (HFrEF', 'patients with heart failure and reduced ejection receiving', 'patients with HFrEF']","['autonomic regulation therapy', 'autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS']","['Echocardiographic parameters and HF symptoms', 'left ventricular (LV) function and HF symptoms', 'device-related SAEs or malfunctions', 'LVEF, NYHA class, 6-min walk distance, and MLHFQ score', 'LVEF and 6-min walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0426096,"At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'Sanjivani Super Specialty Hospitals, Ahmedabad, India.'}, {'ForeName': 'Rajendra K', 'Initials': 'RK', 'LastName': 'Premchand', 'Affiliation': 'Krishna Institute of Medical Sciences, Secunderabad, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Medanta, The Medicity, Haryana, India.'}, {'ForeName': 'Rufino', 'Initials': 'R', 'LastName': 'Monteiro', 'Affiliation': 'Vintage Hospital, Goa, India.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Libbus', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Lorenzo A', 'Initials': 'LA', 'LastName': 'DiCarlo', 'Affiliation': 'BioDev LLC, San Francisco, CA, United States of America.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ardell', 'Affiliation': 'University of California at Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Amurthur', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'KenKnight', 'Affiliation': 'LivaNova PLC, Inc., Houston, TX, United States of America.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'University of Minnesota, Minneapolis, MN, United States of America. Electronic address: anand001@umn.edu.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.072']
3234,33038432,Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis.,"BACKGROUND AND AIMS


Nonalcoholic steatohepatitis is a leading cause of end-stage liver disease. Hepatic steatosis and lipotoxicity result in chronic necroinflammation and direct hepatocellular injury resulting in cirrhosis, end-stage liver disease and hepatocellular carcinoma. Emricasan is a pan-caspase inhibitor that inhibits excessive apoptosis and inflammation, and decreased portal pressures and improved synthetic function in mice with CCl 4 -induced cirrhosis.
METHODS


This double-blind, placebo-controlled study randomized 217 subjects with decompensated NASH cirrhosis 1:1:1 to emricasan (5 or 25 mg) or placebo. Patients were stratified by decompensation status and baseline MELD-Na score. The primary endpoint was comprised of any subject who died, had a new decompensation event (new or recurrent variceal hemorrhage, new ascites requiring diuretics, new unprecipitated hepatic encephalopathy ≥ grade 2, hepatorenal syndrome, spontaneous bacterial peritonitis), or an increase in MELD-Na score ≥4 points.
RESULTS


There was no difference in event rates between either of the emricasan treatment groups and placebo, with hazard ratios of 1.02 (5 mg; 95% confidence interval 0.59, 1.77; p=0.94) and 1.28 (25 mg; 95% confidence interval 0.75, 2.21; p=0.37). MELD-Na score progression was the most common outcome. There was no significant effect of emricasan treatment on MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score. Emricasan was generally safe and well-tolerated.
CONCLUSIONS


Emricasan was safe but ineffective in treatment of decompensated NASH cirrhosis with regard to MELD-Na score improvement, reducing new decompensation events, improving liver function or mortality. However, this study may guide the design and conduct of future clinical trials in decompensated NASH cirrhosis.",2020,"There was no significant effect of emricasan treatment on MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score.","['217 subjects with decompensated NASH cirrhosis 1:1:1 to emricasan (5 or 25 mg) or', 'decompensated NASH cirrhosis', 'mice with CCl 4 -induced cirrhosis', 'patients with NASH-related decompensated cirrhosis']","['MELD', 'placebo']","['MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score', 'new decompensation events, improving liver function or mortality', 'event rates', 'safe and well-tolerated', 'Na score progression', 'synthetic function', 'new decompensation event (new or recurrent variceal hemorrhage, new ascites requiring diuretics, new unprecipitated hepatic encephalopathy ≥ grade 2, hepatorenal syndrome, spontaneous bacterial peritonitis']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0007537', 'cui_str': 'Cefaclor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C3854424', 'cui_str': 'Child-Pugh-Turcotte score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0333106', 'cui_str': 'Bleeding varices'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",217.0,0.509743,"There was no significant effect of emricasan treatment on MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Frenette', 'Affiliation': 'Department of Organ Transplant, Scripps Clinic, La Jolla, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mena', 'Affiliation': 'California Liver Research Institute, Pasadena, CA.'}, {'ForeName': 'Parvez S', 'Initials': 'PS', 'LastName': 'Mantry', 'Affiliation': 'Methodist Health System Clinical Research Institute, Dallas, TX.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Lucas', 'Affiliation': 'Diabetes & Endocrinology Consultants, PC, Moorhead City, NC.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, Lakewood Ranch, FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'IMIC Inc, Palmetto Bay, FL.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Thuluvath', 'Affiliation': 'Mercy Medical Center, Baltimore, MD.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Weinberg', 'Affiliation': 'University of Pennsylvania Medical Center, Philadelphia, PA.'}, {'ForeName': 'Bal R', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Bastrop, LA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wedick', 'Affiliation': 'SimulStat, Inc., Solana Beach, CA.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Chan', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Hagerty', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, WA. Electronic address: kkowdley@liverinstitutenw.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.09.029']
3235,33038502,"A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study.","Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. Lanifibranor (IVA337), a panPPAR agonist, by acting on these three different PPAR isotypes, combines pharmacological effects that could address the different components of the disease as demonstrated in preclinical models. Objectives NATIVE study (EudraCT: 2016-001979-70, NCT: NCT03008070) aims to assess the safety and the efficacy of a 24-week treatment with lanifibranor (800 and 1200 mg/day) in adult non-cirrhotic NASH patients. The primary efficacy endpoint is a 2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis. Design NATIVE is a Phase 2b randomised, placebo-controlled, double-blind, parallel-assignment, dose-range study. Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score ≥ 1. There is no specific criterion related to the fibrosis score except that patients with cirrhosis (F4) were excluded. Summary This study will evaluate the efficacy of a 24-week treatment of NASH with lanifibranor based on histological evaluations (SAF score) by biopsy. The number of responders according to the SAF Activity score-based definition from baseline to 24 weeks will be compared between groups and serves as primary endpoint.",2020,"The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis.","['adult subjects with non-alcoholic steatohepatitis', 'adult non-cirrhotic NASH patients', 'Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score\u202f≥', 'patients with cirrhosis (F4']","['lanifibranor', 'placebo', 'NASH with lanifibranor']","['histological evaluations (SAF score', '2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C5139734', 'cui_str': 'lanifibranor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",,0.191775,"The Peroxysomal Proliferator-Activated Receptors, PPARα, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis.","[{'ForeName': 'Francque', 'Initials': 'F', 'LastName': 'Sven', 'Affiliation': 'Department of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, 2610 Wilrijk, Belgium; Belgium & Laboratory of Experimental Medicine and Paediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Belgium. Electronic address: Sven.Francque@uza.be.'}, {'ForeName': 'Bedossa', 'Initials': 'B', 'LastName': 'Pierre', 'Affiliation': ""Liverpat, 28 rue de l'Amiral Hamelin, 75116 Paris, France.; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, Upon Tyne, UK.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Abdelmalek Manal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Duke University, 40 Duke Medicine Circle, Durham, NC 27710, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anstee Quentin', 'Affiliation': 'Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne, UK; Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bugianesi', 'Initials': 'B', 'LastName': 'Elisabetta', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, A.O. Città della Salute e della Scienza di Torino, Corso Bramante, 88 I-10126 Torino, Italy.'}, {'ForeName': 'Ratziu', 'Initials': 'R', 'LastName': 'Vlad', 'Affiliation': ""AP-HP Hopital Pitié-Salpetrière, 47 Boulevard de L'Hôpital, 75013 Paris, France.""}, {'ForeName': 'Huot-Marchand', 'Initials': 'HM', 'LastName': 'Philippe', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Scherrer', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Bruno Scherrer Conseil S.A.R.L., 15 rue Beethoven, 78730 Saint Arnoult en Yvelines, France.'}, {'ForeName': 'Junien', 'Initials': 'J', 'LastName': 'Jean-Louis', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Broqua', 'Initials': 'B', 'LastName': 'Pierre', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}, {'ForeName': 'Abitbol', 'Initials': 'A', 'LastName': 'Jean-Louis', 'Affiliation': 'INVENTIVA S.A., 50 rue de DIJON, 21121 Daix, France.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106170']
3236,33038504,Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design.,"Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximizing opportunities for extinction learning during a five-week pre-quit period. The primary aims of the RCT are to test the effects of the FE intervention versus a standard (cognitive-behavioral) intervention, while also comparing two nicotine reduction schedules for providing very low nicotine content (VLNC) cigarettes. The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.",2020,The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.,['seeking smokers (n\u202f=\u202f208'],"['RCT', 'FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes', 'FE intervention versus a standard (cognitive-behavioral) intervention']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],208.0,0.0167905,The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.,"[{'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Conn', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Yenis L', 'Initials': 'YL', 'LastName': 'Lorenzo', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Sawyer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, United States of America; Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Wake Forest School of Medicine, Wake Forest University, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, United States of America; Department of Psychology, University of South Florida, Tampa, FL, United States of America. Electronic address: david.drobes@Moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106172']
3237,33038505,The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.,"Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.",2020,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,['section 1115 Medicaid demonstration waiver with community engagement requirements'],['control group who would retain their current benefits as part of the existing Medicaid expansion program'],[],"[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0281739,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,"[{'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Underhill', 'Affiliation': 'Columbia Law School, New York, NY, USA; Department of Population and Family Health, Mailman School of Public Heath, Columbia University, New York, NY, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Dixon', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ferrell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Margrethe E', 'Initials': 'ME', 'LastName': 'Montgomery', 'Affiliation': 'NORC at the University of Chicago, Bethesda MD and Chicago, IL, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Equity Research and Promotion, Cresencz VA Medical Center, Philadelphia, USA.'}, {'ForeName': 'Atheendar S', 'Initials': 'AS', 'LastName': 'Venkataramani', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA. Electronic address: atheenv@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106173']
3238,33038506,A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial.,"BACKGROUND


Cardiovascular disease (CVD) remains the leading cause of death globally. Seven health factors are associated with ideal cardiovascular health: being a non-smoker; not overweight; physically active; having a healthy diet; and normal blood pressure; fasting plasma glucose and cholesterol. Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
OBJECTIVE


We will evaluate whether the NUYou cardiovascular mHealth intervention is more effective than an active comparator to promote cardiovascular health during the transition to young adulthood.
METHODS


302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1) Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD. Both groups will receive smartphone applications, co-designed with students to help them manage time, interact with other participants via social media, and report health behaviors weekly. The CVH group will also have self-monitoring features to track their risk behaviors. Cardiovascular health will be assessed at the beginning of freshman year and the end of freshman and sophomore years. Linear mixed models will be used to compare groups on a composite of the seven cardiovascular-related health factors.
SIGNIFICANCE


This is the first entirely technology-mediated multiple health behavior change intervention delivered to college students to promote cardiovascular health. Findings will inform the potential for primordial prevention in young adulthood.
TRIAL REGISTRATION NUMBER


clinicaltrials.gov #NCT02496728.",2020,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","['young adulthood', 'college students', '302 incoming freshmen at a midwest university will be cluster randomized by dormitory into one of two mHealth intervention groups: 1']","['Cardiovascular Health (CVH), addressing behaviors related to CVD risk; or 2) Whole Health (WH), addressing behaviors unrelated to CVD', 'CVH', 'NUYou cardiovascular mHealth intervention']",['Cardiovascular health'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",302.0,0.114352,"Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood.
","[{'ForeName': 'Angela F', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: angela@northwestern.edu.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'University of Sydney, Australia. Electronic address: katrina.champion@sydney.edu.au.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Finch', 'Affiliation': 'NORC at the University of Chicago, United States of America. Electronic address: Finch-laura@norc.org.'}, {'ForeName': 'Juned', 'Initials': 'J', 'LastName': 'Siddique', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: Siddique@northwestern.edu.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, United States of America. Electronic address: hedeker@uchicago.edu.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Northwestern University Feinberg School of Medicine, United States of America. Electronic address: bspring@northwestern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106162']
3239,33038521,Randomized CLINICAL TRIAL comparing side to end VS end to end techniques for colorectal anastomosis.,"BACKGROUND


Low anterior resection syndrome affects 60% to 90% of patients with anastomoses after colorectal resection. Consensus regarding the best anastomosis is lacking.
OBJECTIVE


To compare outcomes after end-to-end versus side-to-end anastomoses.
DESIGN


Randomized clinical trial.
SETTINGS


University hospital (April 2016-October 2017).
PATIENTS


Patients aged ≥18 years with rectal or sigmoid adenocarcinoma.
INTERVENTIONS


Patients were randomized to undergo mechanical end-to-end or side-to-end (n=33) anastomosis after laparoscopic resection.
MAIN OUTCOME MEASURES


Primary outcome was to assess intestinal function (COREFO and LARS questionnaires) 12 months after surgery or ileostomy closure. Secondary outcomes were postoperative complications and intestinal function and quality of life (SF-36® questionnaire) at different time points after surgery or ileostomy closure.
RESULTS


No significant differences in intestinal function were observed between the two groups 12 months after surgery. Subanalysis of low-mid rectum tumors with end-to-end anastomosis yielded better function at 12 months. Postoperative complications did not differ between the two groups (p=0.070), but reinterventions were more common in the side-to-end group (p=0.040). Multivariate analysis found neoadjuvant treatment was independently associated with intestinal dysfunction at 12 months (β=0.41, p=0.033, COREFO; β=0.41, p=0.024, LARS).
CONCLUSIONS


End-to-end anastomosis yielded low rates of severe complications and reintervention, as well as better intestinal function at 12 months in the subgroup with tumors in the low-mid rectum.
TRIAL REGISTRATION


clinicaltrials.gov identifier: NCT02746224.",2020,"Postoperative complications did not differ between the two groups (p=0.070), but reinterventions were more common in the side-to-end group (p=0.040).","['Patients aged ≥18 years with rectal or sigmoid adenocarcinoma', 'colorectal anastomosis', 'patients with anastomoses after colorectal resection', 'University hospital (April 2016-October 2017']",['mechanical end-to-end or side-to-end (n=33) anastomosis after laparoscopic resection'],"['intestinal function', 'intestinal function (COREFO and LARS questionnaires) 12 months after surgery or ileostomy closure', 'Postoperative complications', 'intestinal dysfunction', 'postoperative complications and intestinal function and quality of life (SF-36® questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0278307', 'cui_str': 'Coloproctostomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.197003,"Postoperative complications did not differ between the two groups (p=0.070), but reinterventions were more common in the side-to-end group (p=0.040).","[{'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Planellas', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain. Electronic address: planellasp@gmail.com.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Farrés', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Cornejo', 'Affiliation': 'Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Rodríguez-Hermosa', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pigem', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Timoteo', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Ortega', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Codina-Cazador', 'Affiliation': 'Department of Surgery, Dr Josep Trueta University Hospital; Girona, Spain; Department of Medical Sciences, Faculty of Medicine, University of Girona; Girona, Spain; Girona Biomedical Research Institute (IDIBGI); Girona, Spain.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.039']
3240,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION


E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD


The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS


The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
3241,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND


Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS


This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS


Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION


Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
3242,33031018,Spleen contraction and Hb elevation after dietary nitrate intake.,"Ingestion of dietary nitrate (NO 3 - ) is associated with improved exercise tolerance and reduced oxygen (O 2 ) cost of exercise, ascribed to enhanced mitochondrial efficiency, muscle contractile function or other factors. Nitrate ingestion has also been found to attenuate the reduction in arterial oxygen saturation (SaO 2 ) during apnea and prolong apneic duration. The spleen serves as a dynamic blood pool expelling erythrocytes into the circulation during apnea, and NO 3 -  and nitric oxide donors may induce vasoactive effects in the mesenteric and splanchnic circulation. Our aim was to investigate the effect of ingestion of concentrated organic NO 3 -  -rich beetroot juice (BR) on spleen volume and spleen contraction during apnea, and the resulting hemoglobin concentration (Hb). Eight volunteers performed two apneas of submaximal and maximal duration during prone rest ~2.5h after ingesting 70 mL of BR (~5 mmol NO 3 - ) or placebo (PL; ~ 0.003 mmol NO 3 - ), on separate days in weighted order. Heart rate and SaO 2  were monitored continuously and spleen diameters were measured every minute for tri-axial volume calculation. Capillary Hb samples were collected at baseline and after the maximal apnea. Baseline spleen volume was reduced by 66 ml after BR ingestion (22.9 %; p=0.026) and Hb was elevated (+3.0 %; p=0.015). During apneas spleen contraction and Hb increase were similar between BR and PL conditions (NS). The study shows that dietary NO 3 -  reduces spleen volume at rest resulting in increased Hb. This spleen-induced Hb-elevation following NO 3 -  ingestions represents a novel mechanism that could enhance performance in conditions involving exercise, apnea and hypoxia.",2020,Baseline spleen volume was reduced by 66 ml after BR ingestion (22.9 %; p=0.026) and Hb was elevated (+3.0 %; p=0.015).,[],"['Ingestion of dietary nitrate (NO 3 - ', 'placebo', 'Nitrate ingestion', 'concentrated organic NO 3 -  -rich beetroot juice (BR']","['apneas of submaximal and maximal duration', 'spleen volume and spleen contraction during apnea, and the resulting hemoglobin concentration (Hb', 'Baseline spleen volume', 'spleen volume', 'Heart rate and SaO 2', 'Spleen contraction and Hb elevation', 'exercise tolerance and reduced oxygen (O 2 ) cost of exercise', 'arterial oxygen saturation (SaO 2 ) during apnea and prolong apneic duration']",[],"[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]",8.0,0.0276239,Baseline spleen volume was reduced by 66 ml after BR ingestion (22.9 %; p=0.026) and Hb was elevated (+3.0 %; p=0.015).,"[{'ForeName': 'Harald Kåre', 'Initials': 'HK', 'LastName': 'Engan', 'Affiliation': 'Department of Health Sciences, Mid Sweden University, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung & Vascular Health, University of British Columbia Okanagan, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Lodin-Sundström', 'Affiliation': 'Department of Health Sciences, Mid Sweden University, Sweden.'}, {'ForeName': 'Hampus', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Health Sciences, Mid Sweden University, Sweden.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Melin', 'Affiliation': 'Department of Health Sciences, Mid Sweden University, Sweden.'}, {'ForeName': 'Erika Kerstin', 'Initials': 'EK', 'LastName': 'Schagatay', 'Affiliation': 'Department of Engineering and Sustainable Development, Mid Sweden University, Sweden.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00236.2020']
3243,33031130,The Impact of Nurse-Led Cardiac Rehabilitation on Quality of Life and Biophysiological Parameters in Patients With Heart Failure: A Randomized Clinical Trial.,"BACKGROUND


Cardiovascular diseases are the leading cause of mortality in the Indian subcontinent, accounting for 38% of deaths annually. One cardiovascular disease in particular, heart failure, is a growing public health problem both in India and worldwide.
PURPOSE


Heart failure is a chronic, progressive disease with increasing rates of incidence and prevalence. This study was conducted to determine the influence of a nurse-led cardiac rehabilitation program on quality of life and biophysiological parameters in patients with chronic heart failure. In this study, it was hypothesized that participants in the cardiac rehabilitation program would report significantly more-positive changes in quality of life and biophysiological parameters than their peers who did not participate in this program.
METHODS


In this randomized controlled trial, the participants were patients with chronic heart failure who had been admitted to a tertiary care hospital in India. The participants assigned to the intervention group received both nurse-led cardiac rehabilitation and routine care. In addition, intervention group participants received a booklet on cardiac rehabilitation, Healthy Way to Healthy Heart, at discharge and fortnightly telephone reminders about good cardiac rehabilitation practices. A standard questionnaire was used to collect targeted information on participants' general and disease-specific quality of life at 1 and 3 months postintervention. Biophysiological parameters such as body mass index, blood pressure, and serum cholesterol values were also measured.
RESULTS


Two thirds of the participants in each group (65% in the intervention group and 66% in the control group) were between 51 and 70 years old. The mean score for the mental component summary of generic quality of life steadily decreased in the control group and steadily increased in the intervention group at the first and second posttests.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


Nurses working in cardiology units play a pivotal role in educating and managing the health status of patients with heart failure. Providing cardiac rehabilitation to patients with heart failure benefits the quality of life of these patients. Nurses working in cardiology units should encourage patients with heart failure to practice cardiac rehabilitation for a longer period to further improve their quality of life.",2020,"The mean score for the mental component summary of generic quality of life steadily decreased in the control group and steadily increased in the intervention group at the first and second posttests.
","['Patients With Heart Failure', 'patients with heart failure', 'patients with chronic heart failure', 'participants were patients with chronic heart failure who had been admitted to a tertiary care hospital in India']","['booklet on cardiac rehabilitation, Healthy Way to Healthy Heart, at discharge and fortnightly telephone reminders about good cardiac rehabilitation practices', 'nurse-led cardiac rehabilitation and routine care', 'Nurse-Led Cardiac Rehabilitation', 'nurse-led cardiac rehabilitation program']","['body mass index, blood pressure, and serum cholesterol values', 'Quality of Life and Biophysiological Parameters', 'quality of life and biophysiological parameters', 'mean score for the mental component summary of generic quality of life steadily', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]",,0.0405611,"The mean score for the mental component summary of generic quality of life steadily decreased in the control group and steadily increased in the intervention group at the first and second posttests.
","[{'ForeName': 'Porkodi', 'Initials': 'P', 'LastName': 'Arjunan', 'Affiliation': ''}, {'ForeName': 'Ramakrishnan Venkatakrishnan', 'Initials': 'RV', 'LastName': 'Trichur', 'Affiliation': 'MD, Professor, Department of Emergency Medicine, Sri Ramachandra Institute of Higher Education & Research (DU), Chennai, India.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000407']
3244,33031148,Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.,"OBJECTIVES


Recurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects.
DESIGN, SETTING, AND PATIENTS


Secondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


Of 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm.
CONCLUSIONS


The design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.",2020,"Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit.","['Trials were eligible for inclusion if published between 2008 and 2018 in leading journals', 'critically ill adults']",[],"['mortality risk difference at the study-specific follow-up interval', 'mortality', 'mortality fell']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.394729,"Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit.","[{'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Abrams', 'Affiliation': 'Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Sydney B', 'Initials': 'SB', 'LastName': 'Montesi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Sarah K L', 'Initials': 'SKL', 'LastName': 'Moore', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Manson', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Kaitlin M', 'Initials': 'KM', 'LastName': 'Klipper', 'Affiliation': 'Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Case', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brodie', 'Affiliation': 'Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Beitler', 'Affiliation': 'Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}]",Critical care medicine,['10.1097/CCM.0000000000004568']
3245,33031156,Proportion and predictors of adult TB contacts accepting HIV testing during an active TB case finding intervention in South Africa.,"BACKGROUND


Many individuals at risk for HIV may be reached through active TB case finding interventions in areas with highly prevalent co-epidemics of TB/HIV.
METHODS


We analyzed data from a cluster-randomized trial of two TB case finding strategies: facility-based screening and contact investigation of newly identified TB cases. In both arms, on-site rapid HIV testing was offered to all contacts over the age of 18 months who did not self-report HIV-positive status. Those who were HIV-infected were referred appropriately. All contacts 15 years and older were included in this analysis.
RESULTS


Among 2179 contacts identified, 50% (1092) accepted HIV testing and counselling, of whom 6.3% (68) tested HIV-positive. Contacts who were unemployed (adjusted prevalence ratio [aPR] 1.14, 95% CI 1.04, 1.25), had not been to a clinic (aPR 1.09, 95% CI 1.02, 1.18) or HIV tested (aPR 1.25, 95% CI 1.14, 1.39) six months prior, and those reporting gastrointestinal symptoms (aPR 1.22, 95% CI 0.98, 1.52) and genitourinary symptoms (aPR 1.30, 95% CI 1.17, 1.45) were significantly associated with accepting HIV testing. Women (aOR 2.19, 95% CI 1.26, 3.81), individuals with a past history of TB (aOR 1.96, 95% CI 0.93, 4.14), and those not HIV tested six months prior (aOR 2.20, 95% CI 1.28, 3.79) were significantly associated with testing HIV positive.
CONCLUSION


Offering HIV testing in the context of active TB case finding represents an opportunity to identify a large proportion of previously undiagnosed individuals with HIV in a population that might otherwise not seek testing.",2020,"Among 2179 contacts identified, 50% (1092) accepted HIV testing and counselling, of whom 6.3% (68) tested HIV-positive.","['Those who were HIV-infected were referred appropriately', 'adult TB contacts accepting HIV testing during an active TB case finding intervention in South Africa', 'Contacts who were unemployed (adjusted prevalence ratio [aPR', 'All contacts 15 years and older were included in this analysis', '2179 contacts identified, 50% (1092) accepted HIV testing and counselling, of whom 6.3% (68) tested HIV-positive']",[],"['reporting gastrointestinal symptoms', 'genitourinary symptoms']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}]",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0426317', 'cui_str': 'Genitourinary symptoms'}]",,0.510659,"Among 2179 contacts identified, 50% (1092) accepted HIV testing and counselling, of whom 6.3% (68) tested HIV-positive.","[{'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Albaugh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Lesego', 'Initials': 'L', 'LastName': 'Mmolawa', 'Affiliation': 'Perinatal HIV Research Unit, Soweto, South Africa.'}, {'ForeName': 'Tsundzukani', 'Initials': 'T', 'LastName': 'Siwelana', 'Affiliation': 'Perinatal HIV Research Unit, Soweto, South Africa.'}, {'ForeName': 'Limakatso', 'Initials': 'L', 'LastName': 'Lebina', 'Affiliation': 'Perinatal HIV Research Unit, Soweto, South Africa.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martinson', 'Affiliation': 'Perinatal HIV Research Unit, Soweto, South Africa.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Hanrahan', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002509']
3246,33031162,Decrease of Postchemotherapy Complications With the Use of Probiotics in Children With Acute Lymphoblastic Leukemia.,"INTRODUCTION


During the administration of antineoplastic drugs, acute complications because of toxicity occur, determining their hospital readmission, visits to the emergency department, use of antimicrobials, and possibilities of presenting systemic infections, impacting on their life quality.
METHODS


Through a prospective cohort, 60 children with acute lymphoblastic leukemia were followed-up for 30 days after the hospital discharge because of chemotherapy administration, those patients were previously included in a single-blinded study in which 30 (group 1) received Lactobacillus rhamnosus GG probiotic during the administration of chemotherapy. The remaining 30 patients did not receive probiotics (group 2). There were evaluated gastrointestinal symptoms, such as diarrhea, dyspepsia, abdominal distension, meteorism, constipation, nausea, and vomit, development of infections, antibiotic use, number of emergency department visits, number of hospitalizations, and sepsis diagnosis.
STATISTICAL ANALYSIS


To assess the impact of the use of probiotics, the difference in proportions between both study groups was evaluated.
RESULTS


Gastrointestinal manifestations (nausea, vomiting, diarrhea, constipation) occurred in 30% of patients in group 1 versus 63% of group 2 (P=0.009). Nine of 30 patients (30.0%) in group 1 went to the emergency room, versus 33.3% of group 2 (P=0.7). Antimicrobials were used in 8 subjects (26.6%) in group 1 versus 6 subjects (53.3%) in group 2 (P=0.03) suspected of an infectious disease. Four (13.3%) group 1 patients were hospitalized versus 30% of group 2 (P=0.1). Two subjects (6.6%) in group 1 had sepsis versus 7 (23.3%) in group 2 (P=0.07).
CONCLUSIONS


The results indicate that the use of probiotics can be a great alternative in the improvement of gastrointestinal symptoms and the adverse effects associated with chemotherapy.",2020,"Gastrointestinal manifestations (nausea, vomiting, diarrhea, constipation) occurred in 30% of patients in group 1 versus 63% of group 2 (P=0.009).","['60 children with acute lymphoblastic leukemia were followed-up for 30 days after the hospital discharge because of chemotherapy administration, those patients were previously included in a single-blinded study in which 30 (group 1) received', 'Children With Acute Lymphoblastic Leukemia']","['Lactobacillus rhamnosus GG probiotic', 'Probiotics']","['Postchemotherapy Complications', 'gastrointestinal symptoms, such as diarrhea, dyspepsia, abdominal distension, meteorism, constipation, nausea, and vomit, development of infections, antibiotic use, number of emergency department visits, number of hospitalizations, and sepsis diagnosis', 'sepsis', 'Gastrointestinal manifestations (nausea, vomiting, diarrhea, constipation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}]",60.0,0.029963,"Gastrointestinal manifestations (nausea, vomiting, diarrhea, constipation) occurred in 30% of patients in group 1 versus 63% of group 2 (P=0.009).","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Reyna-Figueroa', 'Affiliation': 'South Central Hospital of High Specialty, Mexican Petroleum.'}, {'ForeName': 'Arely Anahí', 'Initials': 'AA', 'LastName': 'Bejarano-Juvera', 'Affiliation': 'South Central Hospital of High Specialty, Mexican Petroleum.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'García-Parra', 'Affiliation': 'South Central Hospital of High Specialty, Mexican Petroleum.'}, {'ForeName': 'Elsa E', 'Initials': 'EE', 'LastName': 'Barrón-Calvillo', 'Affiliation': 'South Central Hospital of High Specialty, Mexican Petroleum.'}, {'ForeName': 'Gloria E', 'Initials': 'GE', 'LastName': 'Queipo-Garcia', 'Affiliation': 'General Hospital of Mexico Health Secretary, Mexico.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galindo-Delgado', 'Affiliation': 'South Central Hospital of High Specialty, Mexican Petroleum.'}]",Journal of pediatric hematology/oncology,['10.1097/MPH.0000000000001956']
3247,33031169,Effect of ambulatory blood pressure monitoring guided antihypertensive treatment on renal progression in patients with chronic kidney disease: a randomized comparative study.,"OBJECTIVES


Adequate blood pressure (BP) control is pivotal for managing chronic kidney disease (CKD). The optimal approach for monitoring BP to delay CKD progression is not yet clear.
METHODS


Patients with hypertension and CKD stage 3-4 were randomized into ambulatory blood pressure monitoring (ABPM) or office BP groups. All patients had ABPM at baseline and 18 months, and the ABPM group additionally underwent ABPM at 3 and 6 months. Each ABPM result was notified only for the ABPM group. The BP target was daytime ABP less than 135/85 mmHg for the ABPM group and office BP less than 140/90 mmHg for the office BP group. The primary outcome was decrease in estimated glomerular filtration rate (eGFR) during 18 months.
RESULTS


A total of 146 patients were randomized into the ABPM (n = 69) and office BP groups (n = 77). Although office BP was comparable in the two groups at baseline, daytime ABP was higher in the ABPM group (median 140 vs. 132 mmHg). Initial eGFR was 35.7 ± 12.5 ml/min per 1.73 m in the ABPM group and 34.6 ± 12.0 ml/min per 1.73 m in the office BP group. eGFR change was -5.5 [95% confidence interval (95% CI) -7.7 to  -3.4] ml/min per 1.73 m in the ABPM group and -5.0 (95% CI -6.9 to -3.0) ml/min per 1.73 m in the office BP group (P = 0.704). Renal events occurred in 10 patients (15.6%) from the ABPM group and five (7.1%) from the office BP group (P = 0.120).
CONCLUSION


The present study did not show a beneficial effect of ABPM for controlling hypertension in CKD compared with conventional office BP monitoring in terms of renal outcomes.",2020,The present study did not show a beneficial effect of ABPM for controlling hypertension in CKD compared with conventional office BP monitoring in terms of renal outcomes.,"['Patients with hypertension and CKD stage 3-4', 'patients with chronic kidney disease', '146 patients']","['ambulatory blood pressure monitoring (ABPM) or office BP groups', 'ABPM', 'ambulatory blood pressure monitoring guided antihypertensive treatment']","['estimated glomerular filtration rate (eGFR', 'office BP', 'renal progression', 'daytime ABP', 'eGFR change', 'Initial eGFR', 'Renal events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",146.0,0.0599218,The present study did not show a beneficial effect of ABPM for controlling hypertension in CKD compared with conventional office BP monitoring in terms of renal outcomes.,"[{'ForeName': 'Yunmi', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Jayoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Medical Research Collaborating Center, Seoul National University Hospital and Seoul National University College of Medicine.'}, {'ForeName': 'Sung Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University.'}, {'ForeName': 'Suah', 'Initials': 'S', 'LastName': 'Sung', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Institute of Kidney Disease Research, Yonsei University College of Medicine.'}, {'ForeName': 'Kyu-Beck', 'Initials': 'KB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'Young-Hwan', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Truewords Dialysis Clinic, Incheon.'}, {'ForeName': 'Taehee', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Sun Woo', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Yeong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Inje University Busan Paik Hospital, Busan.'}, {'ForeName': 'Kook-Hwan', 'Initials': 'KH', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}]",Journal of hypertension,['10.1097/HJH.0000000000002624']
3248,33031171,Ambulatory blood pressure adaptations to high-intensity interval training: a randomized controlled study.,"OBJECTIVE


Hypertension remains the leading cause of cardiovascular disease and premature mortality globally. Although high-intensity interval training (HIIT) is an effective nonpharmacological intervention for the reduction of clinic blood pressure (BP), very little research exists regarding its effects on ambulatory BP. The aim of this study was to measure alterations in ambulatory and clinic BP following HIIT in physically inactive adults.
METHODS


Forty-one participants (22.8 ± 2.7 years) were randomly assigned to a 4-week HIIT intervention or control group. The HIIT protocol was performed on a cycle ergometer set against a resistance of 7.5% bodyweight and consisted of 3 × 30-s maximal sprints separated with 2-min active recovery. Clinic and ambulatory BP was recorded pre and post the control period and HIIT intervention.
RESULTS


Following the HIIT intervention, 24-h ambulatory BP significantly decreased by 5.1 mmHg in sBP and 2.3 mmHg in dBP (P = 0.011 and 0.012, respectively), compared with the control group. In addition, clinic sBP significantly decreased by 6.6 mmHg compared with the control group (P = 0.021), with no significant changes in dBP and mean BP (mBP). Finally, 24-h ambulatory diastolic, daytime sBP, mBP and dBP, and night-time sBP and mBP variability significantly decreased post-HIIT compared with the control group.
CONCLUSION


HIIT remains an effective intervention for the management of BP. Our findings support enduring BP reduction and improved BP variability, which are important independent risk factors for cardiovascular disease.",2020,"In addition, clinic sBP significantly decreased by 6.6 mmHg compared with the control group (P = 0.021), with no significant changes in dBP and mean BP (mBP).","['Forty-one participants (22.8\u200a±\u200a2.7 years', 'physically inactive adults']","['HIIT intervention or control group', 'dBP', 'high-intensity interval training (HIIT']","['clinic sBP', 'clinic blood pressure (BP', 'dBP and mean BP (mBP', '24-h ambulatory BP', 'BP variability', 'Ambulatory blood pressure adaptations', '24-h ambulatory diastolic, daytime sBP, mBP and dBP, and night-time sBP and mBP variability', 'Clinic and ambulatory BP', 'ambulatory and clinic BP']","[{'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",41.0,0.017876,"In addition, clinic sBP significantly decreased by 6.6 mmHg compared with the control group (P = 0.021), with no significant changes in dBP and mean BP (mBP).","[{'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Edwards', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Taylor', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cottam', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}, {'ForeName': 'Navazh', 'Initials': 'N', 'LastName': 'Jalaludeen', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'Damian A', 'Initials': 'DA', 'LastName': 'Coleman', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Wiles', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': ""Department of Cardiology, St George's Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': ""O'Driscoll"", 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Canterbury.'}]",Journal of hypertension,['10.1097/HJH.0000000000002630']
3249,33031172,Obstructive sleep apnea is more severe in men but not women with refractory hypertension compared with controlled resistant hypertension.,"OBJECTIVES


Obstructive sleep apnea (OSA) is associated with treatment-resistant hypertension (RHTN) and may contribute to refractory hypertension (RfHTN). The objective of the current study was to test the hypothesis that patients with RfHTN have more severe OSA compared with patients with controlled RHTN.
METHODS


Patients (n = 187) referred to the University of Alabama at Birmingham Hypertension Clinic for evaluation and treatment of RHTN, defined as uncontrolled blood pressure (BP) (SBP ≥ 130 mmHg or DBP ≥ 80 mmHg) despite the use of at least three antihypertensive medications including a diuretic, were enrolled following completion of at least three follow-up clinic visits. RfHTN was defined as uncontrolled high BP despite treatment with five or more antihypertensive agents of different classes, including a long-acting thiazide-type diuretic and a mineralocorticoid receptor antagonist. Following enrollment, all patients (n = 130) completed 24-h ambulatory BP measurement and overnight diagnostic polysomnography during normal nightly use of continuous positive airway pressure. Analyses examined the severity of OSA and related sleep characteristics among patients with RfHTN versus controlled RHTN.
RESULTS


Of the 130 evaluated patients, 37 (28.5%) had RfHTN and 93 (71.5%) had controlled RHTN. In unadjusted analyses, there was not a significant difference in OSA severity, oxygen saturation, or hypoxemia time in patients with RfHTN versus controlled RHTN (P > 0.05). Men with RfHTN had more severe OSA compared with men with controlled RHTN (P = 0.044). In adjusted analyses, OSA severity was associated with sex (P < 0.0001), but not hypertension phenotype (P = 0.17).
CONCLUSION


The severity of OSA may contribute to RfHTN status in men but not women.",2020,Men with RfHTN had more severe OSA compared with men with controlled RHTN (P = 0.044).,"['men but not women', 'Of the 130 evaluated patients, 37 (28.5%) had RfHTN and 93 (71.5%) had controlled RHTN', 'Patients (n\u200a=\u200a187) referred to the University of Alabama at Birmingham Hypertension Clinic for evaluation and treatment of RHTN, defined as uncontrolled blood pressure (BP) (SBP\u200a≥\u200a130\u200ammHg or DBP\u200a≥', 'Obstructive sleep apnea (OSA']",[],"['24-h ambulatory BP measurement and overnight diagnostic polysomnography', 'OSA severity', 'OSA severity, oxygen saturation, or hypoxemia time', 'severity of OSA and related sleep characteristics', 'severe OSA', 'Obstructive sleep apnea']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0860493', 'cui_str': 'Refractory hypertension'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",[],"[{'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",187.0,0.0300354,Men with RfHTN had more severe OSA compared with men with controlled RHTN (P = 0.044).,"[{'ForeName': 'S Justin', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Siddiqui', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Judd', 'Affiliation': 'Division of Nephrology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': 'Sleep/Wake Disorders Center.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Harding', 'Affiliation': 'Sleep/Wake Disorders Center.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Calhoun', 'Affiliation': 'Sleep/Wake Disorders Center.'}]",Journal of hypertension,['10.1097/HJH.0000000000002631']
3250,33031175,Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial.,"OBJECTIVE


Limited data exist on the optimum level of SBP in thrombolyzed patients with acute ischemic stroke (AIS). We aimed to determine the effects of intensive blood pressure (BP) lowering, specifically in patients with severe AIS who participated in the international, Enhanced Control of Hypertension and Thrombolysis Stroke Study.
METHODS


Prespecificed subgroup analyzes of the BP arm of Enhanced Control of Hypertension and Thrombolysis Stroke Study, a multicenter, partial-factorial, open, blinded outcome assessed trial, in which 2227 thrombolysis-eligible and treated AIS patients with elevated SBP (>150 mmHg) were randomized to intensive (target 130-140 mmHg) or guideline-recommended (<180 mmHg) BP management. Severe stroke was defined by computed tomography or magnetic resonance angiogram confirmation of large-vessel occlusion, receipt of endovascular therapy, final diagnosis of large artery atheromatous disease, or high (>10) baseline neurological scores on the National Institutes of Health Stroke Scale. The primary efficacy outcome was death or any disability (modified Rankin scale scores 2-6). The key safety outcome was intracranial hemorrhage (ICH). Treatment effects estimated in logistic regression models are reported as odds ratios (ORs) with 95% confidence intervals (CIs).
RESULTS


There were 1311 patients [mean age 67 years; 37% female; median baseline National Institutes of Health Stroke Scale of 11 (range 6.0-15.0)] with severe AIS. Overall, there was no significant difference in the primary outcome of death or disability. However, intensive BP lowering significantly increased mortality (OR 1.52, 95% CI 1.09-2.13; P = 0.014) compared with guideline BP lowering, despite significantly lowering clinician-reported ICH (OR 0.63, 95% CI 0.43-0.92; P = 0.016).
CONCLUSION


Intensive BP lowering is associated with increased mortality in patients with severe AIS despite lowering the risk of ICH. Further randomized trials are required to provide reliable evidence over the optimum SBP target in the most serious type of AIS.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01422616.",2020,"However, intensive BP lowering significantly increased mortality (OR 1.52, 95% CI 1.09-2.13; P = 0.014) compared with guideline BP lowering, despite significantly lowering clinician-reported ICH (OR 0.63, 95% CI 0.43-0.92; P = 0.016).
","['patients with severe ischemic stroke in the ENCHANTED trial', 'thrombolyzed patients with acute ischemic stroke (AIS', '1311 patients [mean age 67 years; 37% female; median baseline National Institutes of Health Stroke Scale of 11 (range 6.0-15.0)] with severe AIS', 'patients with severe AIS who participated in the international, Enhanced Control of Hypertension and Thrombolysis Stroke Study', 'Prespecificed subgroup analyzes of the BP arm of Enhanced Control of Hypertension and Thrombolysis Stroke Study, a multicenter, partial-factorial, open, blinded outcome assessed trial, in which 2227 thrombolysis-eligible and treated AIS patients with elevated SBP (>150\u200ammHg']","['intensive blood pressure (BP', 'intensive-blood pressure versus standard-blood pressure-lowering treatment']","['death or any disability (modified Rankin scale scores 2-6', 'death or disability', 'intracranial hemorrhage (ICH', 'Severe stroke', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",2227.0,0.426009,"However, intensive BP lowering significantly increased mortality (OR 1.52, 95% CI 1.09-2.13; P = 0.014) compared with guideline BP lowering, despite significantly lowering clinician-reported ICH (OR 0.63, 95% CI 0.43-0.92; P = 0.016).
","[{'ForeName': 'Jatinder S', 'Initials': 'JS', 'LastName': 'Minhas', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service, Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Uo Neurologia, Unità Sanitaria Locale Umbria 1, Sedi di Citta di Castello e Branca, Trento, Italy.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Departamento de Desarrollo Académico e Investigación, Unidad de Investigación y Ensayos Clínicos, Clínica Alemana, Universidad del Desarrollo, Concepción, Chile.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham.'}, {'ForeName': 'Alice C', 'Initials': 'AC', 'LastName': 'Durham', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sheila O', 'Initials': 'SO', 'LastName': 'Martins', 'Affiliation': 'Neurology Service Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul and Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Faculty of Medicine, The George Institute for Global Health, University of New South Wales.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002640']
3251,33031181,Termination of the ESH-CHL-SHOT trial.,,2020,,[],[],[],[],[],[],,0.0651366,,"[{'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'FuWai Hospital and Cardiovascular Institute.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Università Milano-Bicocca, Milan.'}]",Journal of hypertension,['10.1097/HJH.0000000000002660']
3252,33031185,Combined Trabeculotomy-trabeculectomy versus Trabeculectomy for Treatment of Silicone Oil-induced Ocular Hypertension.,"PRéCIS:: Combined trabeculotomy-trabeculectomy has a significantly better hypotensive effect than trabeculectomy and a higher success rate in cases of silicone oil-induced ocular hypertension.
PURPOSE


To compare the ocular hypotensive effect of combined trabeculotomy-trabeculectomy (CTT) with mitomycin-C (MMC) to that of trabeculectomy with MMC in cases of silicone oil-induced ocular hypertension.
PATIENTS AND METHODS


Thirty eyes of thirty patients with high intraocular pressure (IOP) after vitrectomy and silicone oil injection (followed by silicone oil removal) were randomly allocated to 2 groups in this randomized trial. Group A was composed of 15 cases who underwent combined CTT with MMC while group B cases contained 15 cases undergoing trabeculectomy with MMC. Patients were followed up for 12 months. We included patients > 18 years old, having performed vitrectomy and silicone oil injection followed by oil removal, and having IOP > 21▒mmHg uncontrollable by anti-glaucoma medications.
RESULTS


The postoperative IOP drop was significantly greater in group A than in group B at all follow up visits (P < 0.05). Compared to preoperative IOP, both surgeries produced a significantly lower postoperative IOP at all follow up visits (P < 0.05). For group A, complete success rates (IOP≤21▒mmHg without ocular hypotensive medications) and qualified success rates (IOP≤ 21▒mmHg with or without ocular hypotensive medications) were both higher than for group B.
CONCLUSION


Both surgeries effectively reduce IOP in cases of silicone oil-induced ocular hypertension, but CTT has a significantly better hypotensive effect and a higher success rate on the long-term.",2020,The postoperative IOP drop was significantly greater in group A than in group B at all follow up visits (P < 0.05).,"['patients > 18 years old, having performed vitrectomy and silicone oil injection followed by oil removal, and having IOP > 21▒mmHg uncontrollable by anti-glaucoma medications', 'cases of silicone oil-induced ocular hypertension', 'Thirty eyes of thirty patients with high intraocular pressure (IOP) after vitrectomy and silicone oil injection (followed by silicone oil removal']","['trabeculotomy-trabeculectomy', 'combined trabeculotomy-trabeculectomy (CTT) with mitomycin-C (MMC', 'combined CTT with MMC', 'trabeculectomy with MMC', 'Combined Trabeculotomy-trabeculectomy versus Trabeculectomy']","['postoperative IOP drop', 'Ocular Hypertension', 'postoperative IOP', 'qualified success rates', 'hypotensive effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}]","[{'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",30.0,0.0263884,The postoperative IOP drop was significantly greater in group A than in group B at all follow up visits (P < 0.05).,"[{'ForeName': 'Tarek Ahmed', 'Initials': 'TA', 'LastName': 'El Maamoun', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Hisham Samy', 'Initials': 'HS', 'LastName': 'Shalaby', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001702']
3253,33031298,"SUZYTM forceps facilitate nasogastric tube insertion under McGRATHTM MAC videolaryngoscopic guidance: A randomized, controlled trial.","BACKGROUND


Nasogastric tubes can be easily inserted in patients under general anesthesia. However, for difficult cases, insertion techniques that can be used in routine clinical practice are limited. SUZY forceps are designed for the removal of pharyngolaryngeal foreign bodies under guidance of a McGrath videolaryngoscope. We hypothesized that using SUZY forceps under McGrath videolaryngoscopic guidance may facilitate nasogastric tube insertion and tested this in a randomized controlled trial.
METHODS


Adult patients who underwent gastrointestinal or hepato-pancreato-biliary surgery were randomly allocated to 2 groups; the SUZY group and the Magill group. Patients, nurses, and all clinical staff except for the attending anesthesiologist were blinded to group assignment throughout the study. After anesthesia induction, insertion of the nasogastric tube was performed by skilled anesthesiologists with either SUZY or Magill forceps according to group allocation under McGrath videolaryngoscopic guidance. The primary endpoint was insertion time which was defined as the time required to advance the nasogastric tube by 55 cm from the nostril. Secondary endpoints were the success rates of the nasogastric tube insertion, which were defined as a 55-cm advancement from the nostril at the 1st, 2nd, and 3rd attempt, proper insertion rate, the severity of pharyngolaryngeal complications, and hemodynamic parameters during nasogastric tube insertion.
RESULTS


Sixty patients were randomized and none of these patients were excluded from the final analysis. The median [interquartile range] insertion time was 25 [18-33] seconds in the SUZY group, and 33 [21-54] seconds in the Magill group (P = .02). Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10). Both, the severity score of the mucosal injury and the severity of sore throat were higher in the Magill than in the SUZY group, whereas the degree of hoarseness did not differ between the 2 groups. Hemodynamic parameters were not significantly different between the groups.
CONCLUSION


Using SUZY forceps under McGrath videolaryngoscopic guidance reduced the time required to insert a nasogastric tube and the severity of pharyngolaryngeal complications, when compared to using Magill forceps.",2020,"Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10).","['Sixty patients', 'Adult patients who underwent gastrointestinal or hepato-pancreato-biliary surgery', 'patients under general anesthesia']","['SUZY or Magill forceps according to group allocation under McGrath videolaryngoscopic guidance', 'SUZY group and the Magill group']","['Success rates', 'time required to insert a nasogastric tube and the severity of pharyngolaryngeal complications', 'severity score of the mucosal injury and the severity of sore throat', 'Hemodynamic parameters', 'median [interquartile range] insertion time', 'degree of hoarseness', 'success rates of the nasogastric tube insertion, which were defined as a 55-cm advancement from the nostril at the 1st, 2nd, and 3rd attempt, proper insertion rate, the severity of pharyngolaryngeal complications, and hemodynamic parameters', 'insertion time which was defined as the time required to advance the nasogastric tube']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C1828004', 'cui_str': 'Magill forceps, device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205437', 'cui_str': 'Third'}]",60.0,0.0965615,"Success rates were not different between the groups (97% and 80% in the SUZY and Magill group at 1st attempt, respectively, P = .10).","[{'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Furutani', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Minami-Uonuma, Niigata, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kamiya', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Anesthesiology, Niigata University Medical and Dental Hospital.'}]",Medicine,['10.1097/MD.0000000000022545']
3254,33031329,Effects of dapagliflozin on cardiovascular outcomes in type 2 diabetes: Study protocol of a randomized controlled trial.,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. This current research is a double blinded, randomized, and prospective trial to determine the effect of dapagliflozin on cardiovascular outcomes in type 2 diabetes.
METHODS


This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001). All the patients received the informed consent. Diabetic patients were randomized equally to receive 28-week treatment with dapagliflozin or matching placebo. The major outcome of our current study was the change in the level of hemoglobin A1c (HbA1c) from the baseline to week 28. Secondary outcome measures contained the levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose in patients treated with insulin at baseline, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.
RESULTS


We assumed that the dapagliflozin administration in patients with type 2 diabetes would reduce HbA1c, body weight, systolic blood pressure, and achieve the goal of glycemic control, without adversely impacting cardiovascular risk.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5987).",2020,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","['type 2 diabetes', 'patients with type 2 diabetes', 'Diabetic patients', 'Lianyungang Hospital affiliated to Xuzhou Medical University (LW-20200901001']","['dapagliflozin or matching placebo', 'dapagliflozin']","['cardiovascular outcomes', 'laboratory variables, and self-reported adverse events', 'levels of fasting blood glucose, the mean change in seated systolic and diastolic blood pressure, body weight, and the mean change in calculated average daily insulin dose', 'HbA1c, body weight, systolic blood pressure', 'level of hemoglobin A1c (HbA1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.258031,"BACKGROUND


Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'Department of endocrinology, Lianyungang Hospital affiliated to Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': ''}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022660']
3255,33031335,Impacts of cognitive behavior therapy on occupational stress among science and social science education facilitators in open and distance learning centers and its implications for community development: A randomized trial group.,"BACKGROUND


Extensive review of literature showed that no available study in Nigeria has explored the impact of cognitive behavior therapy (CBT) on the management of occupational stress among open and distance learning (ODL) centers science and social science education facilitators. Thus, this study determined the impacts of CBT on the management of occupational stress among science and social science education facilitators in ODL centers in South-South Nigeria.
METHODS


A randomized controlled trial experimental design was adopted for the study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria. Perceived stress scale (PSS) and Occupational stress index (OSI) were used for data collection. Using Cronbach alpha method, internal consistency reliability indices of 0.81 and 0.85 for PSS and OSI respectively were obtained in the Nigerian context. A 12-week cognitive behavior therapy intervention was conducted after which the participants in both the intervention group and the non-intervention group were administered posttest, while a follow-up assessment was administered after 2 months. Data collected were analyzed using mixed-design repeated-measures analysis of variance for the within-groups and between-groups effects.
RESULTS


It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
CONCLUSION


Cognitive behavior therapy is effective in the management of occupational stress among science and social science education facilitators in distance learning centers.",2020,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","['study with a sample size of 68 science and social science education facilitators in ODL centers in South-South states, Nigeria', 'ODL centers in South-South Nigeria']","['CBT', 'cognitive behavior therapy intervention', 'cognitive behavior therapy (CBT', 'Cognitive behavior therapy', 'CBT intervention', 'cognitive behavior therapy']","['Perceived stress scale (PSS) and Occupational stress index (OSI', 'occupational stress']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0037434', 'cui_str': 'Social Sciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0600563', 'cui_str': 'Distance Learning'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",68.0,0.0278059,"It was found that CBT intervention led to a significant decrease in the occupational stress among science and social science education facilitators in ODL in the South-South region of Nigeria.
","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi Justina', 'Initials': 'NJ', 'LastName': 'Igwe', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ngozi M', 'Initials': 'NM', 'LastName': 'Eya', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Jovita C', 'Initials': 'JC', 'LastName': 'Ejimonye', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Basil C', 'Initials': 'BC', 'LastName': 'Oguguo', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chinyere L', 'Initials': 'CL', 'LastName': 'Chukwu', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Obiozor', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Maryrose N', 'Initials': 'MN', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Ruphina U', 'Initials': 'RU', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Uzoamaka L', 'Initials': 'UL', 'LastName': 'Koledoye', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education.'}, {'ForeName': 'Queendaline O', 'Initials': 'QO', 'LastName': 'Ibenegbu', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Francis E', 'Initials': 'FE', 'LastName': 'Ikeh', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Monday', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}, {'ForeName': 'Florence O', 'Initials': 'FO', 'LastName': 'Attah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chiamaka K', 'Initials': 'CK', 'LastName': 'Ugwuanyi', 'Affiliation': 'Department of Social Science Education, Faculty of Education.'}]",Medicine,['10.1097/MD.0000000000022677']
3256,33031340,The efficacy of bilateral intervertebral foramen block for pain management in percutaneous endoscopic lumbar discectomy: A protocol for randomized controlled trial.,"BACKGROUND


Compared with open lumbar microdiscectomy, percutaneous endoscopic lumbar discectomy (PELD) has the advantages of remarkable preservation of paravertebral structures, less bleeding, shorter operation time and fewer complications, it is a common method for the treatment of lumbar disc herniation (LDH). Local anesthesia is recommended during PELD. However, intraoperative pain is sometimes difficult to control satisfactorily. The efficacy of bilateral intervertebral foramen block (IFB) for pain management in PELD remains unclear. Therefore, this regimen is utilized in a randomized controlled trial for the assessment the safety and effectiveness of bilateral IFB for PELD pain control.
METHOD


This is a single center and randomized controlled trial which will be implemented from September 2020 to September 2021. This research protocol is in accordance with the items of the Standard Protocol for Randomized Trials, which was authorized through the Ethics Committee of Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou University (HZCH0465-0864). 100 participants who undergo PELD will be analyzed. Inclusion criteria containsThe exclusion criteria contains:Patients will be randomly divided into bilateral IFB group (with 50 patients) and local infiltration analgesia group (with 50 patients). Primary outcomes are pain score at different time points. The secondary outcomes are the operative time, radiation exposure time, length of hospital stay and postoperative complications. All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
RESULTS


The clinical outcome variables between groups are illustrated in the Table 1.
CONCLUSION


This investigation can offer a reliable basis for the effectiveness and safety of IFB in treating the PELD pain.
TRIAL REGISTRATION


This study protocol is registered in Research Registry (researchregistry5985).",2020,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","['September 2020 to September 2021', '100 participants who undergo PELD will be analyzed', 'percutaneous endoscopic lumbar discectomy']","['IFB', 'bilateral intervertebral foramen block', 'local infiltration analgesia', 'bilateral IFB', 'percutaneous endoscopic lumbar discectomy (PELD', 'bilateral intervertebral foramen block (IFB']","['pain score', 'operative time, radiation exposure time, length of hospital stay and postoperative complications']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",100.0,0.179244,"All the analysis is implemented through applying the IBM SPSS Statistics for Windows, version 20 (IBM Corp., Armonk, NY, USA).
","[{'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Sang', 'Affiliation': 'Department of operating room, Huzhou Central Hospital & Affiliated Central Hospital of Huzhou University.'}, {'ForeName': 'Hanmin', 'Initials': 'H', 'LastName': 'Shan', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics and Trauma, Huzhou Central Hospital & Affiliated Centre Hospital of Huzhou Unversity, Zhejiang Province, China.'}]",Medicine,['10.1097/MD.0000000000022693']
3257,31522806,"Young men who have sex with men's awareness, acceptability, and willingness to participate in HIV vaccine trials: Results from a nationwide online pilot study.","BACKGROUND


New cases of human immunodeficiency virus (HIV) among young men who have sex with men (YMSM) underscore the need to examine their willingness to use biomedical prevention methods, including an acceptable and efficacious HIV vaccine. We examined whether YMSM's vaccine altruism and vaccine-related socials concerns factors were associated with HIV vaccine acceptability across two vaccine efficacy scenarios, and their awareness and willingness to participate in HIV vaccine research.
METHODS


This secondary analysis uses data from a mHealth trial with YMSM at heightened HIV risk (N = 137; 50% racial/ethnic minority; M = 21.7 years). Most YMSM (91.2%) had tested for HIV, and 17.5% (N = 24) reported a prior STI.We used paired-samples t-test to compare differences in efficacy acceptability (50% vs 85%), followed by multivariable regressions examining whether vaccine attitudes (altruism and social concerns) were associated with vaccine acceptability and awareness and willingness to participate in HIV vaccine trials. We controlled for age, education, race/ethnicity, prior HIV testing, and STI diagnosis in our analyses.
RESULTS


Acceptability for the HIV vaccine with 85% efficacy (M = 8.86; SD = 1.76) was greater than acceptability in the 50% efficacy scenario (M = 7.60; SD = 2.58). Altruistic attitudes were associated with greater vaccine acceptability at 50% (β = 0.62) and 85% (β = 0.59) efficacy. Higher educational attainment was negatively associated with a vaccine with 50% efficacy (β = -0.20, but not for 85% efficacy. Greater vaccine-related social concerns were negatively associated with HIV vaccine research awareness (AOR = 0.38 (95% CI: 0.22, 0.67). Willingness to participate in a HIV vaccine trial was positively associated with age (β = 0.18) and altruism (β = 0.60), and negatively associated with education (β = -0.21).
CONCLUSIONS


YMSM find HIV vaccines as an acceptable prevention modality and are willing to participate in HIV vaccine trials. Findings highlight the need to consider YMSM's altruistic and social concerns attitudes in HIV vaccine research and explore how to leverage these attitudes in research campaigns. ClinicalTrials.gov Identifier: NCT02842060.",2019,"Willingness to participate in a HIV vaccine trial was positively associated with age (β = 0.18) and altruism (β = 0.60), and negatively associated with education (β = -0.21).
","[""Young men who have sex with men's awareness, acceptability, and willingness to participate in HIV vaccine trials"", 'young men who have sex with men (YMSM']","['YMSM', ""YMSM's vaccine altruism and vaccine""]","['efficacy acceptability', 'vaccine acceptability', 'Altruistic attitudes', 'Higher educational attainment', 'vaccine acceptability and awareness and willingness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002357', 'cui_str': 'Altruism - mental defense mechanism'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0730042,"Willingness to participate in a HIV vaccine trial was positively associated with age (β = 0.18) and altruism (β = 0.60), and negatively associated with education (β = -0.21).
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Connochie', 'Affiliation': 'Department of Family and Community Health, School of Nursing, 418 Curie Blvd., Rm 235L, University of Pennsylvania, Philadelphia, PA 19104, United States. Electronic address: dconno@upenn.edu.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Tingler', 'Affiliation': 'Department of Family and Community Health, School of Nursing, 418 Curie Blvd., Rm 235L, University of Pennsylvania, Philadelphia, PA 19104, United States.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, 418 Curie Blvd., Rm 235L, University of Pennsylvania, Philadelphia, PA 19104, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.08.076']
3258,31568024,Effect of Cuff Pressure on Blood Flow during Blood Flow-restricted Rest and Exercise.,"PURPOSE


This study investigated the relationship between blood flow restriction (BFR) cuff pressure and blood flow at rest and during exercise, with the aim of determining if lower cuff pressures will provide an ischemic stimulus comparable to higher pressures.
METHODS


The relationship between blood flow and cuff pressure at rest was determined by measuring blood flow (Doppler Ultrasound) through the superficial femoral artery (SFA) in 23 adults across a range of pressures (0%-100% Arterial Occlusion Pressure at rest [rAOP]). The interplay between cuff pressure, blood flow and exercise was assessed by determining AOP at rest and during plantar flexion exercise (eAOP) and subsequently measuring the blood flow response to plantar flexion exercise with BFR cuff pressure set to either 40% rAOP or 40% eAOP.
RESULTS


At rest, a nonlinear relationship between cuff pressure and blood flow through the SFA exhibited a plateau at moderate pressures, with nonsignificant differences in blood flow (~9%, P = 1.0) appearing between pressures ranging from 40% to 80% rAOP. While eAOP was greater than rAOP (229 ± 1.5 mm Hg vs 202 ± 1.5 mm Hg, P < 0.01), blood flow during plantar flexion exercise did not significantly differ (P = 0.49) when applying 40% rAOP or 40% eAOP.
CONCLUSIONS


Blood flow through the SFA exhibits a nonlinear relationship with cuff pressure, such that cuff pressures in the range of 40% to 80% rAOP reduce blood flow to approximately the same degree. The BFR interventions opting for lower (e.g., 40% AOP), more comfortable pressures will likely provide an ischemic stimulus comparable to that of higher (80% AOP), less-comfortable pressures.",2020,"did not significantly differ (P = 0.49) when applying 40% rAOP or 40% eAOP.
",['23 adults across a range of pressures (0%-100% Arterial Occlusion Pressure at rest [rAOP'],"['plantar flexion exercise with BFR cuff pressure set to either 40% rAOP or 40% eAOP', 'Cuff Pressure', 'rAOP']","['cuff pressure, blood flow and exercise', 'blood flow', 'blood flow during plantar flexion exercise', 'blood flow and cuff pressure at rest', 'blood flow restriction (BFR) cuff pressure and blood flow', 'cuff pressure and blood flow', 'Blood Flow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]","[{'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0258436,"did not significantly differ (P = 0.49) when applying 40% rAOP or 40% eAOP.
","[{'ForeName': 'Kent W', 'Initials': 'KW', 'LastName': 'Crossley', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'Doran A', 'Initials': 'DA', 'LastName': 'Porter', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Ellsworth', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Caldwell', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'J Brent', 'Initials': 'JB', 'LastName': 'Feland', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Mitchell', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'A Wayne', 'Initials': 'AW', 'LastName': 'Johnson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Egget', 'Affiliation': 'Department of Statistics, Brigham Young University, Provo, UT.'}, {'ForeName': 'Jayson R', 'Initials': 'JR', 'LastName': 'Gifford', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002156']
3259,31907388,Phenome-wide screening for traits causally associated with the risk of coronary artery disease.,"Using two independent approaches, Mendelian randomization and Polygenic risk score in a sample of 6194 CAD cases and 4287 controls of European ancestry, we did a comprehensive phenome-wide search (PheWAS) for traits that causally associated with the risk of CAD. We found 46 risk factors that represented diverse categories including cardiovascular, CNS (central nervous system), diabetes, lipids, immune, anthropometry, and life style features; moreover, we noted numerous evidences of genetic correlations and causal associations between risk factors from different categories. Among the identified risk factors, CAD showed highest genetic relatedness with thrombotic conditions. The most represented category was life style features (29%) with evidence of strong genetic overlap with CNS traits. Genetic variants associated with higher cognition were associated with life style characteristics and cardiometabolic features that lower the risk of CAD. Conditional analysis indicated this trend is in part attributed to higher age of first sexual intercourse (AFS) in those with higher cognition. Lower AFS was concordantly associated with higher risk of CAD in males, females, and the combined sample; furthermore, lower AFS was causally associated with several CAD-risk factors including, higher fasting insulin, fasting glucose, LDL, immature reticulocyte fraction, HbA1c levels, as well as, higher risk of T2D and pulmonary embolism but lower levels of HDL. These results indicate CAD is the outcome of several phenotypically distinct but genetically interrelated sources; moreover, we identified lower AFS as an independent causal risk factor of CAD and revealed its role in mediating the effect of other risk factors.",2020,"Lower AFS was concordantly associated with higher risk of CAD in males, females, and the combined sample; furthermore, lower AFS was causally associated with several CAD-risk factors including, higher fasting insulin, fasting glucose, LDL, immature reticulocyte fraction, HbA1c levels, as well as, higher risk of T2D and pulmonary embolism but lower levels of HDL.",[],[],"['cardiovascular, CNS (central nervous system), diabetes, lipids, immune, anthropometry, and life style features', 'Mendelian randomization and Polygenic risk score', 'fasting insulin, fasting glucose, LDL, immature reticulocyte fraction, HbA1c levels, as well as, higher risk of T2D and pulmonary embolism']",[],[],"[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",6194.0,0.0323067,"Lower AFS was concordantly associated with higher risk of CAD in males, females, and the combined sample; furthermore, lower AFS was causally associated with several CAD-risk factors including, higher fasting insulin, fasting glucose, LDL, immature reticulocyte fraction, HbA1c levels, as well as, higher risk of T2D and pulmonary embolism but lower levels of HDL.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nikpay', 'Affiliation': 'Ruddy Canadian Cardiovascular Genetics Centre, University of Ottawa Heart Institute, Ottawa, ON, K1Y 4W7, Canada. mnikpay@ottawaheart.ca.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mohammadzadeh', 'Affiliation': 'Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, 6714967346, Iran.'}]",Journal of human genetics,['10.1038/s10038-019-0716-z']
3260,33034564,Effect of Smartphone-Based Lifestyle Coaching App on Community-Dwelling Population With Moderate Metabolic Abnormalities: Randomized Controlled Trial.,"BACKGROUND


Metabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.
OBJECTIVE


We assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.
METHODS


In this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.
RESULTS


Between October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).
CONCLUSIONS


Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.",2020,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","['Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with', '160 participants participated in the baseline screening examination', 'Community-Dwelling Population With Moderate Metabolic Abnormalities', 'participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level', 'adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting', 'Between October 28, 2017 and May 28, 2018']","['Simultaneous diet and exercise self-logging and persistent lifestyle modification coaching', 'smartphone-based weight management app', 'Smartphone-Based Lifestyle Coaching App', 'block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching', 'personalized coaching']","['body weight reductions', 'diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level', 'systolic blood pressure', 'metabolic parameters']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",160.0,0.120663,"mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only:","[{'ForeName': 'So Mi Jemma', 'Initials': 'SMJ', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jee-Seon', 'Initials': 'JS', 'LastName': 'Shim', 'Affiliation': 'Cardiovascular and Metabolic Diseases Etiology Research Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyungseon', 'Initials': 'H', 'LastName': 'Yeom', 'Affiliation': 'Department of Medicine, the Graduate School of Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'Jeon', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeon Chang', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of medical Internet research,['10.2196/17435']
3261,33034565,Evaluating the Implementation of a Remote-Monitoring Program for Chronic Obstructive Pulmonary Disease: Qualitative Methods from a Service Design Perspective.,"BACKGROUND


Implementing digital health technologies is complex but can be facilitated by considering the features of the tool that is being implemented, the team that will use it, and the routines that will be affected.
OBJECTIVE


The goal of this study was to assess the implementation of a remote-monitoring initiative for patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework and to refine this approach to conceptualize the adoption of technologies in health care.
METHODS


This study was a qualitative research project that took place alongside a randomized controlled trial comparing a technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program in patients with chronic obstructive pulmonary disease and with standard care. This study included interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators. The interview questions were structured around the 3 main concepts of the Tool+Team+Routine framework.
RESULTS


Findings emphasized that (1) technologies can alter relationships between providers and patients, and that these relationships drove the development of a new service arising from the technology, in our case, and (2) technologies can create additional work that is not visible to management as a result of not being considered within the scope of the service.
CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies. By acknowledging the centrality of such relationships, implementation teams can better plan for the adaptations required in order to make new technologies work for patients and health care providers. Further work will need to address how specific individuals administering a remote-monitoring program work to build relationships, and how these relationships and other sources of activity might lead to technological scope creep-an unanticipated expanding scope of work activities in relation to the function of the tool.",2020,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","['Chronic Obstructive Pulmonary Disease', 'patients and health care providers', 'patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework', 'patients with chronic obstructive pulmonary disease and with standard care', 'interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators']","['Remote-Monitoring Program', 'technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0019949', 'cui_str': 'Hospital administrator'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],5.0,0.0261161,"CONCLUSIONS


Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'van Lieshout', 'Affiliation': 'University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Vess', 'Initials': 'V', 'LastName': 'Stamenova', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cornejo Palma', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sidhu', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Engel', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Erwood', 'Affiliation': 'Markham Stoufville Hospital, Markham, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'Onil', 'Initials': 'O', 'LastName': 'Bhattacharyya', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': ""Women's College Hospital Institute for Health System Solutions and Virtual Care, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/18148']
3262,33034622,"Letter: Medical Management With Interventional Therapy Versus Medical Management Alone for Unruptured Brain Arteriovenous Malformations (ARUBA): Final Follow-up of a Multicentre, Nonblinded, Randomised Controlled Trial.",,2020,,['Unruptured Brain Arteriovenous Malformations (ARUBA'],['Interventional Therapy Versus Medical Management'],[],"[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003857', 'cui_str': 'Congenital arteriovenous malformation'}, {'cui': 'C0282379', 'cui_str': 'Aruba'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.0597684,,"[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Volovici', 'Affiliation': 'Department of Neurosurgery Erasmus MC Stroke Center Erasmus MC Rotterdam, The Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'Schouten', 'Affiliation': 'Department of Neurosurgery Erasmus MC Stroke Center Erasmus MC Rotterdam, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gruber', 'Affiliation': 'Department of Neurosurgery Kepler University Hospital Neuromed Campus Linz, Austria.'}, {'ForeName': 'Torstein R', 'Initials': 'TR', 'LastName': 'Meling', 'Affiliation': 'Neurosurgery Division Department of Clinical Neurosciences Faculty of Medicine Geneva University Hospitals Geneva, Switzerland.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Dammers', 'Affiliation': 'Department of Neurosurgery Erasmus MC Stroke Center Erasmus MC Rotterdam, The Netherlands.'}]",Neurosurgery,['10.1093/neuros/nyaa448']
3263,33034628,Effect of Fluorescence Visualization-Guided Surgery on Local Recurrence of Oral Squamous Cell Carcinoma: A Randomized Clinical Trial.,"Importance


High local recurrence rates with aggressive disease remain the main concern in oral cancer survival. Use of a translational device using fluorescence visualization (FV) approved by the US Food and Drug Administration and Health Canada, has shown a marked reduction in the 3-year local recurrence rate of high-grade oral lesions in a single-center observational study.
Objective


To determine whether FV- guided surgery can improve local control rates in the treatment of in situ or T1 to T2 category oral squamous cell carcinoma (OSCC).
Design, Setting, and Participants


A multicenter randomized clinical trial was conducted in a surgical setting. A total of 457 patients were enrolled between January 18, 2010, and April 30, 2015. Data analysis of the intention-to-treat population was performed from April 3, 2019, to March 20, 2020. Patients with histologically confirmed high-grade dysplasia/carcinoma in situ or T1 to T2 category OSCC were randomized to receive traditional peroral surgery or FV-guided surgery.
Intervention


Fluorescence visualization during surgery.
Main Outcomes and Measures


The primary outcome was local recurrence of OSCC. Secondary outcomes were failure of the first-pass margin, defined as a histologically confirmed positive margin for severe dysplasia or greater histologic change of the main specimen (ie, not the margins taken from the resection bed), regional or distant metastasis, and death due to disease.
Results


Of the 457 patients enrolled in the study, 443 patients (264 [59.6%] men; mean [SD] age, 61.5 [13.3] years) completed the randomized treatment: 227 FV-guided and 216 non-FV guided surgery. The median follow-up was 52 (range, 0.29-90.8) months. In total, 45 patients (10.2%) experienced local recurrence. The 3-year local recurrence rate was 9.4% in the FV-guided group and 7.2% in the non-FV group (difference, 2.2%; 95% CI, -3.2% to 7.4%). Other similarities between the FV vs non-FV groups included failure of first-pass margin (68/227 [30.0%]) vs 65/216 [30.1%]), regional failure (39/227 [17.2%] vs 37/216 [17.1%]), disease-specific survival (23/227 [10.1%] vs 19/26 [8.8%]), and overall survival (41/227 [18.1%] vs 38/216 [17.6%]) were also similar between groups. No adverse events were judged to be related to the intervention.
Conclusions and Relevance


In this randomized clinical trial, FV-guided surgery did not improve local control rates in the treatment of patients with in situ or T1 to T2 category oral cancer. Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC. This result suggests that attention be directed to strategies other than improving definitions of nonapparent disease at clinical margins to identify the sources of local recurrence.
Trial Registration


ClinicalTrial.gov Identifier: NCT01039298.",2020,"Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC.","['443 patients (264 [59.6%] men; mean [SD] age, 61.5 [13.3] years) completed the randomized treatment: 227', '457 patients were enrolled between January 18, 2010, and April 30, 2015', 'Oral Squamous Cell Carcinoma', 'Patients with histologically confirmed high-grade dysplasia/carcinoma in situ or T1 to T2 category OSCC', 'patients with in situ or T1 to T2 category oral cancer', 'in situ or T1 to T2 category oral squamous cell carcinoma (OSCC', '457 patients enrolled in the study']","['FV-guided surgery', 'Fluorescence Visualization-Guided Surgery', 'FV- guided surgery', 'FV-guided and 216 non-FV guided surgery', 'traditional peroral surgery or FV-guided surgery', 'translational device using fluorescence visualization (FV']","['failure of first-pass margin', '3-year local recurrence rate', 'adverse events', 'local recurrence', 'regional failure', 'failure of the first-pass margin, defined as a histologically confirmed positive margin for severe dysplasia or greater histologic change of the main specimen (ie, not the margins taken from the resection bed), regional or distant metastasis, and death due to disease', 'disease-specific survival', 'local control rates', 'local recurrence of OSCC', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0007099', 'cui_str': 'Carcinoma in situ'}, {'cui': 'C0475373', 'cui_str': 'T2 category'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1298904', 'cui_str': 'Device used'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0334048', 'cui_str': 'Severe dysplasia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",457.0,0.202879,"Under a controlled environment, FV-guided surgery did not have an evident effect in reduction of local recurrence for localized OSCC.","[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Durham', 'Affiliation': 'Department of Surgery, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Brasher', 'Affiliation': 'Department of Statistics, Faculty of Science, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Anderson', 'Affiliation': 'Department of Surgery, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery and Oncology, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Dort', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Seikaly', 'Affiliation': 'Division of Otolaryngology, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kerr', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Miriam P', 'Initials': 'MP', 'LastName': 'Rosin', 'Affiliation': 'School of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Poh', 'Affiliation': 'Department of Oral Biological and Medical Sciences, Faculty of Dentistry, The University of British Columbia, Vancouver, British Columbia, Canada.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.3147']
3264,33034794,A novel and easy approach to difficult transseptal puncture during atrial fibrillation ablation.,"AIMS


Transseptal passage is sometimes difficult to obtain. This study evaluates the feasibility and safety of a novel and easy transseptal puncture (TSP) technique named 2D2G (using two dilators and two guidewires) in patients with difficult TSP.
METHODS AND RESULTS


Forty-four paroxysmal atrial fibrillation patients with difficult TSP were enrolled in this study. They were allocated to the 2D2G group or the conventional group in a 1:1 fashion. The primary endpoint in both groups was successful TSP without changing the puncture site or using auxiliary tools. The secondary endpoints were the safety, total transseptal puncture time, and ablation time. There were no differences in baseline demographic or clinical characteristics between the two groups. Successful LA access in the 2D2G group was 100% (vs. 64%, P < 0.05). The total TSP time (10 ± 3 min vs. 5 ± 1 min, P < 0.05) and ablation time (42 ± 19 min vs. 58 ± 22 min, P < 0.05) in the conventional group were significantly longer than those in the 2D2G group. No major complications occurred in either group, and all the patients underwent successful circumferential pulmonary vein isolation (CPVI).
CONCLUSION


In AF patients with difficult TSP, the 2D2G technique is safe, feasible, and time-saving.",2020,"Successful LA access in the 2D2G group was 100% (vs. 64%, P < 0.05).","['Forty-four paroxysmal atrial fibrillation patients with difficult TSP were enrolled in this study', 'patients with difficult TSP']",['novel and easy transseptal puncture (TSP) technique named 2D2G'],"['Successful LA access', 'baseline demographic or clinical characteristics', 'safety, total transseptal puncture time, and ablation time', 'total TSP time', 'successful TSP without changing the puncture site or using auxiliary tools', 'ablation time', 'major complications']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027365', 'cui_str': 'Name'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0253188,"Successful LA access in the 2D2G group was 100% (vs. 64%, P < 0.05).","[{'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Songnan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China. lisongnan@ccmu.edu.cn.'}, {'ForeName': 'Caihua', 'Initials': 'C', 'LastName': 'Sang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Jianzeng', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, 100029, China. chshma@vip.sina.com.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00891-y']
3265,33034900,Local cooling for relieving pain from perineal trauma sustained during childbirth.,"BACKGROUND


Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.
OBJECTIVES


To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.
SELECTION CRITERIA


Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS


We included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain. We undertook a number of comparisons to evaluate the different treatments. Cooling treatment (ice pack or cold gel pad) versus no treatment There was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) -4.46, 95% confidence interval (CI) -5.07 to -3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of -0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance. Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression) There was limited low-certainty evidence that there may be a trivial MD of -0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI -0.73 to -0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants). Cooling treatment (ice pack) versus placebo (water pack) One study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants). Cooling treatment (ice pack) versus cooling treatment (cold gel pad) The evidence is very uncertain about the effects of using ice packs or cold gel pads on women's self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.
AUTHORS' CONCLUSIONS


There is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.",2020,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","['perineal trauma sustained during childbirth', '10 RCTs that enrolled 1233 women']","['Cooling treatment (ice pack) versus cooling treatment (cold gel pad', 'ice packs or cold gel pads', 'placebo', 'Cooling treatment (ice pack or cold gel pad', 'Local cooling', 'cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression', 'Cooling treatment (ice pack) versus placebo (water pack', 'Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression']","['adverse effects on wound healing', 'Perineal oedema', 'perineal pain', 'perineal bruising', 'Levels of perineal oedema', ""women's self-rated perineal pain, on perineal bruising, or on perineal oedema"", 'giving birth (risk ratio (RR', 'pain']","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",250.0,0.513131,"To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
","[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'East', 'Affiliation': 'School of Nursing and Midwifery, La Trobe University/Mercy Hospital for Women, Bundoora, Australia.'}, {'ForeName': 'Emma Df', 'Initials': 'ED', 'LastName': 'Dorward', 'Affiliation': 'Glen Iris, Australia.'}, {'ForeName': 'Rhiannon E', 'Initials': 'RE', 'LastName': 'Whale', 'Affiliation': 'Melbourne, Australia.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Antenatal/Postnatal Ward, Mercy Hospital for Women, Heidelberg, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006304.pub4']
3266,33034942,"A randomized, placebo and active controlled, split scalp study to evaluate the efficacy of platelet rich plasma in patchy alopecia areata of the scalp.","BACKGROUND


Platelet rich plasma (PRP) is a new modality of treatment in the field of dermatology. There are paucity of studies evaluating the effects of PRP in non-scarring alopecia especially alopecia areata.
(AA) OBJECTIVES


To compare the efficacy and safety of PRP in patchy AA of the scalp in a placebo and active controlled trial.
METHOD


This was a randomized, placebo and active controlled, split scalp study. Fifty patients of patchy AA of the scalp were recruited and allocated to two treatment groups. Left side of the scalp received placebo (intralesional normal saline), right side of the scalp received intralesional PRP in one group and intralesional triamcinolone acetonide in second group. Three treatment sessions were given at 4-week interval and final follow up was done at 8 weeks later. SALT scoring, dermoscopy were the parameters used to assess the efficacy.
RESULTS


The SALT score showed statistically significant improvement from baseline in both the treatment groups (p value <0.001). The maximum absolute regrowth was shown by the steroid group followed by PRP followed by placebo group (p value 0.016). Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (p value 0.448).
CONCLUSIONS


PRP is a promising therapy in AA as an adjuvant in those with minimal response and those not tolerating steroids or have developed adverse effects to it. This article is protected by copyright. All rights reserved.",2020,"Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (p value 0.448).
","['patchy alopecia areata of the scalp', 'Fifty patients of patchy AA of the scalp']","['PRP', 'placebo', 'placebo (intralesional normal saline), right side of the scalp received intralesional PRP', 'platelet rich plasma', 'triamcinolone acetonide']","['efficacy', 'dermoscopic findings', 'maximum absolute regrowth']","[{'cui': 'C1862862', 'cui_str': 'Patchy alopecia'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",50.0,0.220652,"Improvement in dermoscopic findings were similar in both the PRP and steroid groups followed by placebo (p value 0.448).
","[{'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Hegde', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Relhan', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Bijaylaxmi', 'Initials': 'B', 'LastName': 'Sahoo', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Vijay Kumar', 'Initials': 'VK', 'LastName': 'Garg', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Santosh Medical College, Ghaziabad, India.'}]",Dermatologic therapy,['10.1111/dth.14388']
3267,32109848,Poor clinical outcomes of intratumoral dendritic cell-specific intercellular adhesion molecule 3-grabbing non-integrin-positive macrophages associated with immune evasion in gastric cancer.,"AIM


Tumour-associated macrophages (TAMs) are prominent immune cells infiltrating in solid tumours with phenotypic and functional heterogeneity. However, the clinical significance of heterogeneous subtypes of TAMs in gastric cancer still remains obscure. Here, we aimed to explore the clinical significance of TAMs expressing dendritic cell-specific intercellular adhesion molecule 3-grabbing non-integrin (DC-SIGN) and its relevance with immune contexture in gastric cancer.
METHODS


We selected 453 formalin-fixed and paraffin-embedded samples and 51 fresh tissue specimens of patients with gastric cancer from Zhongshan Hospital. The association of DC-SIGN +  macrophages with clinicopathological parameters, overall survival (OS) and responsiveness to fluorouracil-based adjuvant chemotherapy (ACT) was inspected. Immunohistochemistry (IHC) and flow cytometry (FCM) were applied to characterize immune cells in gastric cancer.
RESULTS


We demonstrated that high intratumoral DC-SIGN +  macrophages infiltration predicted poor OS and inferior therapeutic responsiveness to fluorouracil-based ACT in patients with gastric cancer. Furthermore, higher infiltration of DC-SIGN +  macrophages indicated an increased number of Foxp3 +  regulatory T cells (Tregs), CD8 +  T cells and a higher ratio of Foxp3 + /CD8 +  within the tumour microenvironment (TME). In addition, CD8 +  T cells in DC-SIGN +  macrophages high subgroup were functionally impaired, showing decreased interferon-γ (IFN-γ), granzyme B (GZMB) and perforin production yet elevated programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) expression.
CONCLUSIONS


DC-SIGN +  macrophages were associated with immunoinvasive TME and indicated poor prognosis and inferior therapeutic responsiveness to fluorouracil-based ACT. DC-SIGN +  macrophages might be an independent prognosticator and a potential immunotherapeutic target for gastric cancer.",2020,DC-SIGN +  macrophages were associated with immunoinvasive TME and indicated poor prognosis and inferior therapeutic responsiveness to fluorouracil-based ACT.,"['patients with gastric cancer', 'gastric cancer', 'patients with gastric cancer from Zhongshan Hospital']","['fluorouracil-based adjuvant chemotherapy (ACT', '453 formalin-fixed and paraffin-embedded samples and 51 fresh tissue specimens', 'fluorouracil-based ACT']","['Immunohistochemistry (IHC) and flow cytometry (FCM', 'interferon-γ (IFN-γ), granzyme B (GZMB) and perforin production yet elevated programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) expression', 'overall survival (OS) and responsiveness', 'number of Foxp3 +  regulatory T cells (Tregs), CD8 +  T cells and a higher ratio of Foxp3 + /CD8 +  within the tumour microenvironment (TME']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0061878', 'cui_str': 'Granzyme B'}, {'cui': 'C0070410', 'cui_str': 'Perforin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C2350360', 'cui_str': 'CTLA4 protein, human'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]",,0.0377508,DC-SIGN +  macrophages were associated with immunoinvasive TME and indicated poor prognosis and inferior therapeutic responsiveness to fluorouracil-based ACT.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ruochen', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Immunology, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Immunology, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.'}, {'ForeName': 'Jieti', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenbin', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: li.he@zs-hospital.sh.cn.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Shanghai Cancer Center, Fudan University, Shanghai, China. Electronic address: huahuang@fudan.edu.cn.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Immunology, School of Basic Medical Sciences, Fudan University, Shanghai, China. Electronic address: weijuanzhang@fudan.edu.cn.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China. Electronic address: jjxufdu@fudan.edu.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.002']
3268,32776980,Associations of spousal communication with contraceptive method use among adolescent wives and their husbands in Niger.,"OBJECTIVES


This study aims to examine associations between spousal communication about contraception and ever use of modern contraception, overt modern contraceptive use (with husband's knowledge), and covert modern contraceptive use (without husband's knowledge) among adolescent wives and their husbands in Niger.
STUDY DESIGN


Cross-sectional data, from the Reaching Married Adolescents Study, were collected from randomly selected adolescent wives (ages 13-19 years) and their husbands from 48 randomly selected villages in rural Niger (N = 1,020 couples). Logistic regression models assessed associations of couples' reports of spousal communication about contraception with wives' reports of contraception (overall, overt, and covert).
RESULTS


About one-fourth of adolescent wives and one-fifth of husbands reported spousal communication about contraception. Results showed couples' reports of spousal communication about contraception were positively associated with ever use of modern contraception. Couples' reports of spousal communication about contraception were negatively associated with covert modern contraceptive use compared to overt use. Wives' reports of spousal communication were marginally associated with covert use compared to no use but husbands' reports were not.
CONCLUSION


Among a sample of couples in Niger, spousal communication about contraception was positively associated with modern contraceptive use (compared to no use) and negatively with covert use (compared to overt use) but wives' and husbands' reports showed differential associations with covert use compared to no use. Since there is little understanding of couple communication surrounding covert contraceptive use decisions, research should focus on characterizing content and context of couple communication particularly in cases of disagreement over fertility decisions.",2020,spousal communication about contraception was positively associated with modern contraceptive use (compared to no use) and negatively with covert use (compared to overt use) but wives' and husbands' reports showed differential associations with covert use compared to no use.,"['adolescent wives and their husbands in Niger', 'Cross-sectional data, from the Reaching Married Adolescents Study, were collected from randomly selected adolescent wives (ages 13-19 years) and their husbands from 48 randomly selected villages in rural Niger (N = 1,020 couples']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0242665', 'cui_str': 'Wife'}, {'cui': 'C0028074', 'cui_str': 'Niger'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",[],[],1020.0,0.0171076,spousal communication about contraception was positively associated with modern contraceptive use (compared to no use) and negatively with covert use (compared to overt use) but wives' and husbands' reports showed differential associations with covert use compared to no use.,"[{'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Challa', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Shakya', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carter', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Sabrina C', 'Initials': 'SC', 'LastName': 'Boyce', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, La Jolla, California, United States of America.'}, {'ForeName': 'Mohamad I', 'Initials': 'MI', 'LastName': 'Brooks', 'Affiliation': 'Pathfinder International, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Sani', 'Initials': 'S', 'LastName': 'Aliou', 'Affiliation': 'Pathfinder International, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Silverman', 'Affiliation': 'Center on Gender Equity and Health, University of California San Diego, La Jolla, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0237512']
3269,33036995,Does load management using the acute:chronic workload ratio prevent health problems? A cluster randomised trial of 482 elite youth footballers of both sexes.,"BACKGROUND


The acute:chronic workload ratio (ACWR) is commonly used to manage training load in sports, particularly to reduce injury risk. However, despite its extensive application as a prevention intervention, the effectiveness of load management using ACWR has never been evaluated in an experimental study.
AIM


To evaluate the effectiveness of a load management intervention designed to reduce the prevalence of health problems among elite youth football players of both sexes.
METHODS


We cluster-randomised 34 elite youth football teams (16 females, 18 males) to an intervention group (18 teams) and a control group (16 teams). Intervention group coaches planned all training based on published ACWR load management principles using a commercially available athlete management system for a complete 10-month season. Control group coaches continued to plan training as normal. The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems.
RESULTS


The between-group difference in health problem prevalence (primary outcome) was 1.8%-points (-4.1 to 7.7 %-points; p=0.55) with no reduction in the likelihood of reporting a health problem in the intervention group (relative risk 1.01 (95% CI 0.91 to 1.12); p=0.84) compared with the control group.
CONCLUSIONS


We observed no between-group difference, suggesting that this specific load management intervention was not successful in preventing health problems in elite youth footballers.
TRIAL REGISTRATION NUMBER


ISRCTN18177140.",2020,"The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems.
","['elite youth football players of both sexes', '34 elite youth football teams (16 females, 18 males) to an intervention group (18 teams) and a control group (16 teams', '482 elite youth footballers of both sexes']","['load management intervention', 'Intervention group coaches planned all training based on published ACWR load management principles using a commercially available athlete management system']","['prevalence of health problems', 'health problem prevalence', 'likelihood of reporting a health problem', 'health problems']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0814471,"The prevalence of health problems was measured monthly in both groups using the Oslo Sports Trauma Research Centre Questionnaire on Health Problems.
","[{'ForeName': 'Torstein', 'Initials': 'T', 'LastName': 'Dalen-Lorentsen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway torstein.dalen@nih.no.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bjørneboe', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clarsen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vagle', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Thor Einar', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Oslo Sports Trauma Research Center, Department of Sports Medicine, Norwegian School of Sports Sciences, Oslo, Norway.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103003']
3270,33037024,Anti-PD-1 plus Chemotherapy Yields 100% Response in Hodgkin Lymphoma.,"In a phase II trial, 30 patients with classic Hodgkin lymphoma had a complete metabolic response.",2020,"In a phase II trial, 30 patients with classic Hodgkin lymphoma had a complete metabolic response.","['30 patients with classic Hodgkin lymphoma', 'Hodgkin Lymphoma']",[],['complete metabolic response'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}]",30.0,0.01402,"In a phase II trial, 30 patients with classic Hodgkin lymphoma had a complete metabolic response.",[],Cancer discovery,['10.1158/2159-8290.CD-RW2020-145']
3271,33037036,Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.,"INTRODUCTION


Investigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.
RESEARCH DESIGN AND METHODS


In this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
RESULTS


In total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28-52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of -1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of -1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.
CONCLUSIONS


Switching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.
TRIAL REGISTRATION NUMBER


NCT01652716.",2020,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","['adults with type 2 diabetes', 'patients with type 2 diabetes', '315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with']","['exenatide QWS-AI (n=197) or exenatide', 'exenatide', 'exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI', 'exenatide QWS-AI', 'exenatide QWS-AI (2\u2009mg) or exenatide']","['clinically relevant A1C reductions', 'glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight', 'Body-weight reductions', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",315.0,0.0159734,"Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.
","[{'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Section of Endocrinology and Metabolism, MultiCare Rockwood Clinic, Spokane, Washington, USA cwysham@multicare.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.'}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Vetter', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'Late clinical development, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Clinical, Diabetes, Metabolism and GI, AstraZeneca, Gaithersburg, Maryland, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000773']
3272,33037080,Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways.,"OBJECTIVE


To characterise the molecular pathways impacted by the pharmacologic effects of the Janus kinase (JAK) 1 and JAK2 inhibitor baricitinib in SLE.
METHODS


In a phase II, 24-week, randomised, placebo-controlled, double-blind study (JAHH), RNA was isolated from whole blood in 274 patients and analysed using Affymetrix HTA2.0 array. Serum cytokines were measured using ultrasensitive quantitative assays.
RESULTS


Gene expression profiling demonstrated an elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes at baseline in patients with SLE. Statistical and gene network analyses demonstrated that baricitinib treatment reduced the mRNA expression of functionally interconnected genes involved in SLE including  STAT1 -target,  STAT2 -target and  STAT4- target genes and multiple IFN responsive genes. At baseline, serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6 were measurable and elevated above healthy controls. Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis. Baricitinib consistently reduced serum levels of two key cytokines implicated in SLE pathogenesis, IL-12p40 and IL-6.",2020,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.",['274 patients and analysed using Affymetrix HTA2.0 array'],"['target and  STAT4', 'placebo']","['Serum cytokines', 'serum IL-12p40 and IL-6 cytokine levels', 'elevation of  STAT1 ,  STAT2  and multiple interferon (IFN) responsive genes', 'mRNA expression', 'serum cytokines IFN-α, IFN-γ, interleukin (IL)-12p40 and IL-6', 'global gene expression', 'RNA expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0255034', 'cui_str': 'STAT4 Protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1432814', 'cui_str': 'STAT1 protein, human'}, {'cui': 'C0295166', 'cui_str': 'Transcription Factor STAT2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",274.0,0.116982,"Treatment with baricitinib significantly decreased serum IL-12p40 and IL-6 cytokine levels at week 12, which persisted through week 24.
CONCLUSION


Baricitinib treatment induced significant reduction in the RNA expression of a network of genes associated with the JAK/STAT pathway, cytokine signalling and SLE pathogenesis.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dörner', 'Affiliation': 'DRFZ Berlin and Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany thomas.doerner@charite.de.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Department of Rheumatology, Cedars-Sinai Medical Center, West Hollywood, California, USA.'}, {'ForeName': 'Ernst R', 'Initials': 'ER', 'LastName': 'Dow', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Rocha', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Crowe', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Benschop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Silk', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'de Bono', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Fantini', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hoffman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000424']
3273,33037118,"Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis.","BACKGROUND


Anti-programmed cell death ligand 1 (PD-L1)/programmed cell death 1 antibodies have shown clinical activity in platinum-treated metastatic urothelial carcinoma, resulting in regulatory approval of several agents, including avelumab (anti-PD-L1). We report ≥2-year follow-up data for avelumab treatment and exploratory subgroup analyses in patients with urothelial carcinoma.
METHODS


Patients with previously treated advanced/metastatic urothelial carcinoma, pooled from two cohorts of the phase Ib JAVELIN Solid Tumor trial, received avelumab 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity or withdrawal. End points included best overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety. Post hoc analyses included objective response rates (ORRs) in subgroups defined by established high-risk/poor-prognosis characteristics and association between time to response and outcome.
RESULTS


249 patients received avelumab; efficacy was assessed in 242 postplatinum patients. Median follow-up was 31.9 months (range 24-43), and median treatment duration was 2.8 months (range 0.5-42.8). The confirmed ORR was 16.5% (95% CI 12.1% to 21.8%; complete response in 4.1% and partial response in 12.4%). Median duration of response was 20.5 months (95% CI 9.7 months to not estimable). Median PFS was 1.6 months (95% CI 1.4 to 2.7 months) and the 12-month PFS rate was 16.8% (95% CI 11.9% to 22.4%). Median OS was 7.0 months (95% CI 5.9 to 8.5 months) and the 24-month OS rate was 20.1% (95% CI 15.2% to 25.4%). In post hoc exploratory analyses, avelumab showed antitumor activity in high-risk subgroups, including elderly patients and those with renal insufficiency or upper tract disease; ORRs were numerically lower in patients with liver metastases or low albumin levels. Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)). Safety findings were consistent with previously reported 6-month analyses.
CONCLUSIONS


After ≥2 years of follow-up, avelumab showed prolonged efficacy and acceptable safety in patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups. Survival appeared longer in patients who responded within 3 months. Long-term safety findings were consistent with earlier reports with avelumab treatment in this patient population.",2020,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"['242 postplatinum patients', 'Patients with previously treated advanced/metastatic urothelial carcinoma', 'patients with platinum-treated advanced/metastatic urothelial carcinoma, including high-risk subgroups', 'patients with urothelial carcinoma']",[],"['Objective response', 'avelumab; efficacy', 'antitumor activity', 'prolonged efficacy and acceptable safety', 'Median PFS', 'confirmed ORR', 'objective response rates (ORRs', 'Survival', 'overall response and progression-free survival (PFS) per RECIST V.1.1, overall survival (OS) and safety', 'longer OS', 'Median OS', 'Median duration of response', '12-month PFS rate', '24-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",242.0,0.186069,Objective response achieved by 3 months versus later was associated with longer OS (median not reached (95% CI 18.9 months to not estimable) vs 7.1 months (95% CI 5.2 to 9.0 months)).,"[{'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Apolo', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA andrea.apolo@nih.gov.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ellerton', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Agrawal', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Associates in Oncology, Rockville, Maryland, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, Nevada, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Gourdin', 'Affiliation': 'Hematology/Oncology, The University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Sint-Augustinus Hospital Oncology Centre, Antwerp, Belgium.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Taylor', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Cancer Institute, Detroit, Michigan, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Manitz', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Pennock', 'Affiliation': 'EMD Serono, Inc, Rockland, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ruisi', 'Affiliation': 'EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Hematology Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001246']
3274,33035416,[The role of sleep in the relational memory processes].,"Background and purpose


A growing body of evidence suggests that sleep plays an essential role in the consolidation of different memory systems, but less is known about the beneficial effect of sleep on relational memory processes and the recognition of emotional facial expressions, however, it is a fundamental cognitive skill in human everyday life. Thus, the study aims to investigate the effect of timing of learning and the role of sleep in relational memory processes.
Methods


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Results


84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female) participated in our study, divided into two groups: evening group and morning group indicating the time of learning. We used the face-name task to measure relational memory and facial expression recognition. There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
Conclusion


Our results suggest that the timing of learning and sleep plays an important role in the stabilizing process of memory representation to resist against forgetting.",2020,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","['84 young adults (average age: 22.36 (SD: 3.22), 21 male/63 female']",['evening group and morning group indicating the time of learning'],['relational memory and facial expression recognition'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",84.0,0.0199132,"There were two sessions for both groups: the immediate testing phase and the delayed retesting phase, separated by 24 hours.
","[{'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Csábi', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Ágnes', 'Initials': 'Á', 'LastName': 'Zámbó', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}, {'ForeName': 'Lídia', 'Initials': 'L', 'LastName': 'Prokecz', 'Affiliation': 'Szegedi Tudományegyetem, Pszichológia Intézet, Kognitív és Neuropszichológia Tanszék, Szeged.'}]",Ideggyogyaszati szemle,['10.18071/isz.73.0327']
3275,33035492,Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fractures Surgeries? A Triple-Blind Randomized Clinical Trial.,"PURPOSE


Hemorrhage is one of the significant factors that cause adverse reactions and complications during trauma management. This study aimed to investigate the effectiveness of preoperative tranexamic acid (TXA) administration on intraoperative blood loss in the mandibular fracture surgeries.
MATERIALS AND METHODS


The authors implemented a triple blinded randomized clinical trial. All healthy young patients who suffered from the bilateral displaced mandibular angle and body fractures were included in this study. All operations were performed using open reduction and internal fixation by the same surgical team. The eligible subjects were randomly divided into 2 equal groups. The anesthesiology staff administered the intravenous TXA (20 mg/kg) to the intervention group and 20 mL of intravenous normal saline (0.09%) in the control group, 30 minutes preoperatively. The study outcome variables included intraoperative blood loss and hemoglobin loss. The data were statistically analyzed in SPSS, version 20 (SPSS Inc, Chicago, IL).
RESULTS


Fifty patients, including 31 males (62%) and 19 females (38%), with the mean age of 28 ± 5.6 years were studied. The mean blood loss was 360.57 ± 173.5 mL and 560.9 ± 248.07 mL in the TXA and control groups, respectively. This difference was statistically significant (P = .008). In addition, the mean drop in hemoglobin value was 0.91 ± 0.33 mg/dL in the intervention group and 1.44 ± 0.45 mg/dL in the control group, with a significant difference (P = .001). No adverse effect was observed in the TXA cases.
CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.",2020,"CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.","['All healthy young patients who suffered from the bilateral displaced mandibular angle and body fractures', 'mandibular fracture surgeries', 'patients who underwent mandibular fracture open reduction and internal fixation surgeries', 'Fifty patients, including 31 males (62%) and 19 females (38%), with the mean age of 28\xa0±\xa05.6 years were studied', 'Mandibular Fractures Surgeries']","['Tranexamic Acid', 'preoperative tranexamic acid (TXA', 'TXA', 'intravenous normal saline']","['adverse effect', 'intraoperative blood loss', 'intraoperative blood loss and hemoglobin loss', 'mean blood loss', 'mean drop in hemoglobin value', 'SPSS, version 20 (SPSS Inc, Chicago, IL']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}]",,0.0519843,"CONCLUSIONS


TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.","[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Khiabani', 'Affiliation': 'Associate professor, Department of Oral & Maxillofacial surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadfar', 'Affiliation': 'Oral & Maxillofacial surgeon, Private practice.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Labafchi', 'Affiliation': 'Dentist, Student Research Committee, Faculty of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Gosheh', 'Affiliation': 'Assistant professor, Department of Anesthesiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Samieirad', 'Affiliation': 'Assistant Professor, Oral and maxillofacial diseases research center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: samieerads@mums.ac.ir.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.011']
3276,33035598,Predicting Heart Failure Events in Patients with Coronary Heart Disease and Impaired Glucose Tolerance: Insights from the Acarbose Cardiovascular Evaluation (ACE) trial.,"AIMS


Heart failure is a fatal complication of type 2 diabetes but little is known about its incidence in people with impaired glucose tolerance (IGT). We used Acarbose Cardiovascular Evaluation (ACE) trial data to identify predictors of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in patients with coronary heart disease (CHD) and IGT randomised to acarbose or placebo.
METHODS


Independent hHF/CV death risk factors were determined using Cox proportional hazards models, with participants censored at first hHF event, CV death, or end of follow-up.
RESULTS


During median 5-year follow-up, the composite outcome of hHF/CV death occurred in 393 (6.0%) participants. Significant hHF/CV death multivariate predictors were higher age and plasma creatinine, as and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke. Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
CONCLUSIONS


Patients with CHD and IGT at greater risk of hHF/CV death were older with higher plasma creatinine, prior HF, MI, AF or stroke. Addition of acarbose to optimised CV therapy to reduce post-prandial glucose excursions did not reduce the risk of hHF/CV death or hHF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, number NCT00829660, and the International Standard Randomised Controlled Trial Number registry, number ISRCTN91899513.",2020,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","['people with impaired glucose tolerance (IGT', 'Patients with Coronary Heart Disease and Impaired Glucose Tolerance', 'patients with coronary heart disease (CHD']","['acarbose or placebo', 'placebo', 'acarbose to optimised CV therapy', 'Acarbose']","['plasma creatinine, as and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke', 'risk of hHF/CV death or hHF', 'heart failure (hHF) or cardiovascular (CV) death', 'hHF/CV death', 'post-prandial glucose excursions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587038', 'cui_str': 'Cardiovascular therapy'}]","[{'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.56588,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wamil', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'J V McMurray', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Standl', 'Affiliation': 'Diabetes Research Group eV at Munich Helmholtz Centre, Munich, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK. Electronic address: rury.holman@dtu.ox.ac.uk.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108488']
3277,33035599,Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: a randomized placebo-controlled trial.,"BACKGROUND


Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD). More and more attention has been paid to the efficacy of liraglutide in the treatment of NAFLD, but the clinical evidence is still insufficient.
OBJECTIVE


The purpose of this study was to use proton magnetic resonance spectroscopy (H-MRS) assessment of metformin alone poor blood glucose control of obese patients type 2 diabetes with NAFLD, added with insulin glargine, liraglutide or placebo effect in improving the fatty liver.
METHODS


This is a 26-week, single-center, prospective, randomized placebo-controlled study. From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital. The primary endpoints were the changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)], from baseline to week 26 (end of treatment) and the changes in liraglutide group or insulin glargine group versus change in placebo group. Secondary endpoints included the changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI.
RESULTS


A total of 96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on insulin glargine, liraglutide, or placebo. After 26 weeks of treatment, compared to the placebo group, in the liraglutide and insulin glargine groups, IHCL significantly decreased from baseline to week 26 (liraglutide 26.4 % ± 3.2% to 20.6% ± 3.9%, P < 0.05; insulin glargine 25.0 % ± 4.3% to 22.6% ± 5.8%, P > 0.05). SAT and VAT decreased significantly in the liraglutide group and in the insulin glargine group (P < 0.05). ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05). In the liraglutide group, AST, ALT, and HOMA-IR decreased significantly from baseline. There was no significant difference in glucose-lowering among the three groups. During the treatment, the safety of the three groups performed well.
CONCLUSION


Compared with placebo, treatment with liraglutide plus an adequate dose of metformin (2000g/ day) for 26 weeks is more effective in reducing IHCL, SAT and VAT in patients with type 2 diabetes and NAFLD. And it has additional advantages in weight loss, waist circumference reduction and liver function improvement.",2020,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","['From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital', 'patients with type 2 diabetes and NAFLD', '96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by', 'obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks', 'obese patients type 2 diabetes with NAFLD, added with']","['insulin glargine, liraglutide or placebo', 'proton magnetic resonance spectroscopy (H-MRS', 'liraglutide', 'insulin glargine, liraglutide, or placebo', 'metformin', 'placebo', 'insulin glargine', 'liraglutide and insulin glargine', 'Liraglutide or insulin glargine treatments']","['changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT', 'changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI', 'blood glucose control', 'weight loss, waist circumference reduction and liver function improvement', 'hepatic fat', 'SAT and VAT', 'glucose-lowering', 'ΔSAT and ΔVAT', 'IHCL, SAT and VAT', 'IHCL', 'AST, ALT, and HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",96.0,0.0676648,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China. Electronic address: xu98111@163.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108487']
3278,33035700,"Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate following once-daily inhalation as a combination in healthy subjects.","Indacaterol (IND), is co-formulated with glycopyrronium (GLY), and mometasone furoate (MF) as a once-daily (o.d.) inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device for maintenance treatment of asthma. We evaluated the steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF or as monotherapies. This was a randomized, open-label, four-way crossover study. Subjects received IND/GLY/MF 150/50/160 μg (high-dose), IND 150 μg, GLY 50 μg or MF 190 μg (in vitro fine particle mass comparable to 160 μg MF in IND/GLY/MF) via the Breezhaler® device, o.d. for 14 days in each period, with a washout of at least 7 days. PK was characterized on Day 14, up to 24h post-dose. In total, 36 healthy subjects were randomized. For IND, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 0.922 (0.878, 0.969) and 1.02 (0.967, 1.08), respectively for the IND/GLY/MF versus IND monotherapy comparison. For GLY, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 0.986 (0.944, 1.03) and 1.21(1.09, 1.34), respectively for the IND/GLY/MF versus GLY comparison. For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison. Similar systemic exposure was noted for IND/GLY/MF versus monotherapy for all three mono-components, indicating a lack of PK interaction. Multiple inhaled doses of IND, GLY and MF were safe and well tolerated, when administered alone or in combination. There was no clinically relevant pharmacokinetic interaction between IND, GLY and MF when administered as IND/GLY/MF.",2020,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","['36 healthy subjects', 'healthy subjects']","['glycopyrronium (GLY), and mometasone furoate (MF', 'IND/GLY/MF', 'inhaled fixed-dose combination (IND/GLY/MF) delivered via the Breezhaler® device', 'IND, GLY and MF', 'Indacaterol (IND', 'indacaterol, glycopyrronium and mometasone furoate']","['geometric mean ratios', 'steady state plasma pharmacokinetics (PK) of IND, GLY and MF following inhalation of IND/GLY/MF', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]",36.0,0.0285696,"For MF, the geometric mean ratios (90% CI) for AUC0-24h, ss and Cmax, ss were 1.16 (1.09, 1.24) and 1.17 (1.09, 1.25), respectively for IND/GLY/MF versus MF comparison.","[{'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ethell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, USA.'}, {'ForeName': 'Nasri', 'Initials': 'N', 'LastName': 'Abdallah', 'Affiliation': 'Novartis Institutes for BioMedical Research Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Machineni', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Drollmann', 'Affiliation': 'Novartis Institutes for BioMedical Research Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Heudi', 'Affiliation': 'Novartis Institutes for BioMedical Research Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Last', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Novartis Institutes for BioMedical Research Translational Medicine, Basel, Switzerland.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Radhakrishnan', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Ignatenko', 'Affiliation': 'Charité Research Organisation GmbH, Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for BioMedical Research Translational Medicine, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101964']
3279,33035731,Smoking Cessation Treatment for Parents who are Light or Very Light Smokers in the Pediatric Setting.,"BACKGROUND


The percentage of U.S. smokers who smoke <10 cigarettes per day has increased, yet it's not known how often light parental smokers are offered and accept cessation assistance in pediatric offices.
METHODS


A secondary analysis of parent interview data collected April-October 2017 at 10 pediatric practices participating in a cluster-randomized controlled trial of the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention.
RESULTS


Forty percent of 725 usual care control (UCC) group smokers smoked lightly (<10 cigarettes per day); of these 58% smoked very lightly (<5 per day). Compared to heavier smokers in UCC practices, light and very light smokers in UCC practices were more likely to have made a recent quit attempt (p < .001), yet less likely to have used cessation medication (p = .001). In intervention practices, compared to heavier smokers, light (p = .04) and very light (p < .01) smokers were less likely to be asked if they smoke and very light smokers were less likely to be advised to quit (p = .02) and to receive a nicotine replacement therapy (NRT) prescription (p < .01). However, light smokers (p < .001), very light smokers (p < .001) and light smokers who use e-cigarettes (p = .01) were more likely to receive assistance (NRT or quitline enrollment) in intervention versus UCC practices.
CONCLUSIONS


The CEASE intervention increased assistance to light and very light smokers, yet heavier smokers received more assistance than light smokers. Improving cessation interventions for light and very light smokers is warranted.",2020,"In intervention practices, compared to heavier smokers, light (p = .04) and very light (p < .01) smokers were less likely to be asked if they smoke and very light smokers were less likely to be advised to quit (p = .02) and to receive a nicotine replacement therapy (NRT) prescription (p < .01).","['parent interview data collected April-October 2017 at 10 pediatric practices participating in a cluster-randomized controlled trial of the', 'Parents who are Light or Very Light Smokers in the Pediatric Setting', 'Forty percent of 725 usual care control (UCC) group smokers smoked lightly (<10 cigarettes per day); of these 58% smoked very lightly (<5 per day']","['Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention', 'CEASE intervention', 'Smoking Cessation Treatment']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0225877,"In intervention practices, compared to heavier smokers, light (p = .04) and very light (p < .01) smokers were less likely to be asked if they smoke and very light smokers were less likely to be advised to quit (p = .02) and to receive a nicotine replacement therapy (NRT) prescription (p < .01).","[{'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Drehmer', 'Affiliation': 'Massachusetts General Hospital, Division of General Academic Pediatrics, Boston, MA, United States; Massachusetts General Hospital, Tobacco Research and Treatment Center, Boston, MA, United States. Electronic address: jdrehmer@mgh.harvard.edu.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Massachusetts General Hospital, Division of General Academic Pediatrics, Boston, MA, United States; Massachusetts General Hospital, Tobacco Research and Treatment Center, Boston, MA, United States. Electronic address: MLUO1@mgh.harvard.edu.'}, {'ForeName': 'Emara', 'Initials': 'E', 'LastName': 'Nabi-Burza', 'Affiliation': 'Massachusetts General Hospital, Division of General Academic Pediatrics, Boston, MA, United States; Massachusetts General Hospital, Tobacco Research and Treatment Center, Boston, MA, United States. Electronic address: enabi@mgh.harvard.edu.'}, {'ForeName': 'Bethany Hipple', 'Initials': 'BH', 'LastName': 'Walters', 'Affiliation': 'Massachusetts General Hospital, Division of General Academic Pediatrics, Boston, MA, United States; Massachusetts General Hospital, Tobacco Research and Treatment Center, Boston, MA, United States. Electronic address: bhipple@mgh.harvard.edu.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Massachusetts General Hospital, Division of General Academic Pediatrics, Boston, MA, United States; Massachusetts General Hospital, Tobacco Research and Treatment Center, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: jwinickoff@mgh.harvard.edu.'}]",Academic pediatrics,['10.1016/j.acap.2020.10.001']
3280,33036174,PromarkerD Predicts Renal Function Decline in Type 2 Diabetes in the Canagliflozin Cardiovascular Assessment Study (CANVAS).,"The ability of current tests to predict chronic kidney disease (CKD) complicating diabetes is limited. This study investigated the prognostic utility of a novel blood test, PromarkerD, for predicting future renal function decline in individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS). PromarkerD scores were measured at baseline in 3568 CANVAS participants ( n  = 1195 placebo arm,  n  = 2373 canagliflozin arm) and used to predict incident CKD (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m 2  during follow-up in those above this threshold at baseline) and eGFR decline ≥30% during the 4 years from randomization. Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3) measured by mass spectrometry were combined with clinical data (age, serum high-density lipoprotein (HDL)-cholesterol, eGFR) using a previously defined algorithm to provide PromarkerD scores categorized as low-, moderate- or high-risk. The participants (mean age 63 years, 33% females) had a median PromarkerD score of 2.9%, with 70.5% categorized as low-risk, 13.6% as moderate-risk and 15.9% as high-risk for developing incident CKD. After adjusting for treatment, baseline PromarkerD moderate-risk and high-risk scores were increasingly prognostic for incident CKD (odds ratio 5.29 and 13.52 versus low-risk, respectively; both  p  < 0.001). Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.",2020,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,['individuals with type 2 diabetes from the CANagliflozin CardioVascular Assessment Study (CANVAS'],[],"['Biomarker concentrations (apolipoprotein A-IV (apoA4), CD5 antigen-like (CD5L/AIM) and insulin-like growth factor-binding protein 3 (IGFBP3', 'PromarkerD scores', 'median PromarkerD score', 'baseline PromarkerD moderate-risk and high-risk scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C1528456', 'cui_str': 'CD5L protein, human'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]",3568.0,0.046152,Analysis of the PromarkerD test system in CANVAS shows the test can predict clinically significant incident CKD in this multi-center clinical study but had limited utility for predicting eGFR decline ≥30%.,"[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Peters', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Bringans', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, The University of Western Australia, Fremantle Hospital, Fremantle, WA 6959, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Hansen', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA 19477, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Lipscombe', 'Affiliation': 'Proteomics International, Nedlands, WA 6009, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9103212']
3281,33036179,"One Year's Treatment with the Glucagon-Like Peptide 1 Receptor Agonist Liraglutide Decreases Hepatic Fat Content in Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus in a Randomized, Placebo-Controlled Trial.","Prior gestational diabetes mellitus (pGDM) is associated with increased risk of nonalcoholic fatty liver disease (NAFLD). Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists has shown beneficial effects in NAFLD patients. We evaluated the effect of the GLP-1 analogue liraglutide on NAFLD features in women with pGDM. Eighty-two overweight/obese, nondiabetic women with pGDM were included. We performed abdominal ultrasound, transient elastography with controlled attenuation parameter (CAP), and blood sampling at baseline and after 1 year. Thirty-seven women were randomized to liraglutide (1.8 mg once-daily) and 45 to placebo. Based on the ultrasound scan, 18 women (22%) had ultrasound-verified NAFLD at baseline and of these, 10 (56%) received liraglutide treatment. After 1 year, eight participants no longer had steatosis, four in each treatment group. The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74). Compared to placebo, liraglutide reduced the CAP-assessed intrahepatic fat content (-28 (-44;-11) vs. 2 (-13;18) dB/m,  p <  0.01) and body weight (-4.7 (-6.4;-2.9) vs. -1.4 (-3;0.3) kg,  p <  0.01). One-year's liraglutide treatment had no effect on the presence of ultrasound-diagnosed NAFLD in overweight/obese nondiabetic women with pGDM, but reduced body weight and steatosis assessed by transient elastography with CAP.",2020,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"['Thirty-seven women', 'Women with Nonalcoholic Fatty Liver Disease and Prior Gestational Diabetes Mellitus', 'Prior gestational diabetes mellitus (pGDM', 'women with pGDM', 'Eighty-two overweight/obese, nondiabetic women with pGDM were included', 'NAFLD patients']","['liraglutide treatment', 'liraglutide', 'glucagon-like peptide 1 (GLP-1) receptor agonists', 'placebo, liraglutide', 'Glucagon-Like Peptide 1 Receptor Agonist Liraglutide', 'placebo', 'GLP-1 analogue liraglutide', 'Placebo']","['presence of ultrasound-diagnosed NAFLD', 'NAFLD features', 'body weight', 'CAP-assessed intrahepatic fat content', 'NAFLD', 'body weight and steatosis']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}]",82.0,0.352378,The number of participants who developed NAFLD was similar in the two treatment groups; five in the liraglutide group and six in the placebo group ( p  = 0.74).,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Vedtofte', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bahne', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Foghsgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jonatan I', 'Initials': 'JI', 'LastName': 'Bagger', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Andreasen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Strandberg', 'Affiliation': 'Department of Radiology, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 4A, 2900 Hellerup, Denmark.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gørtz', 'Affiliation': 'Department of Nuclear Medicine, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 2, 1st floor, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology & Gastroenterology, Aarhus University Hospital, University of Aarhus, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Svare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Borgmester Ib Juuls Vej 21, 2730 Herlev, Denmark.'}, {'ForeName': 'Tine D', 'Initials': 'TD', 'LastName': 'Clausen', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, University of Copenhagen, Dyrehavevej 29, 3400 Hillerød, Denmark.'}, {'ForeName': 'Elisabeth R', 'Initials': 'ER', 'LastName': 'Mathiesen', 'Affiliation': 'Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Lise L', 'Initials': 'LL', 'LastName': 'Gluud', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2, 2820 Gentofte, Denmark.'}]",Journal of clinical medicine,['10.3390/jcm9103213']
3282,33036201,A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial.,"The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55-80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test  n  = 72, control  n  = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants' weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.",2020,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","['163 healthy formula-fed infants, 55-80 days old', 'healthy term infants', '21 infants discontinued the study, while 142 infants completed the study (test  n  = 72, control  n  = 70']","['PHF (test) or the IPF (control) group', 'standard infant formula with intact protein (IPF', 'partially hydrolyzed whey infant formula (PHF']","['daily weight gain', ""infants' weight, length, head circumference, body mass index (BMI), and their Z-scores"", 'Daily weight gain', 'additional anthropometric indices at every timepoint']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3853282', 'cui_str': 'Standard infant formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",163.0,0.293575,"Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day].","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Thijs-Verhoeven', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Gros', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chairistanidou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Zervas', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Filoilia', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Tarek-Michail', 'Initials': 'TM', 'LastName': 'Kampani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Miligkos', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Matiatou', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Valaveri', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Sakellariou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Babilis', 'Affiliation': 'Mitera hospital, 6 Erythrou Stavrou Str., 151 23 Athens, Greece.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, The Netherlands.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, 70 El. Venizelou Ave, 17671 Athens, Greece.'}]",Nutrients,['10.3390/nu12103056']
3283,33036224,Vitamin K Intake in Chronic Stroke: Implications for Dietary Recommendations.,"Previous research has identified a possible association between vitamin K intake and cardiometabolic disease. This could mean that the assessment of vitamin K intake is a meaningful tool when monitoring individuals with preexisting cardiovascular disease. Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings. Participants were divided into two groups: below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation (MET,  n  = 11). Energy and macronutrient intake did not differ between groups (all  p  > 0.127). Vegetable intake was higher in the MET group ( p  = 0.0001). Vitamin K intake was higher in the MET group ( p  = 0.0001). Calcium ( p  = 0.003), vitamin A ( p  = 0.007), and vitamin E ( p  = 0.005) intakes were higher in the MET group. There were no differences in sodium, potassium, vitamin D, vitamin C, and iron intakes between groups (all  p  > 0.212). In this sample of chronic stroke survivors, 82% reported consuming below the Dietary Reference Intake (DRI) for vitamin K. Given that the majority of this study population did not reach the DRI for vitamin K, it is advisable to promote the adequate intake of food rich in vitamin K. Further work is needed to determine the significance of low vitamin K intake in this population.",2020,Vegetable intake was higher in the MET group ( p  = 0.0001).,"['Sixty chronic stroke survivors (men and women, body mass index (BMI) 30.36 ± 6.61 kg/m 2 , age 61.7 ± 7.2 years) completed food records which were analyzed for energy, macronutrient, micronutrient, and food group servings', 'individuals with preexisting cardiovascular disease', 'Chronic Stroke']","['vitamin K intake', 'below vitamin K recommendation (BEL,  n  = 49) and met vitamin K recommendation', 'Vitamin K Intake']","['Vegetable intake', 'Vitamin K intake', 'vitamin E', 'Energy and macronutrient intake', 'sodium, potassium, vitamin D, vitamin C, and iron intakes']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]","[{'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0518043', 'cui_str': 'Iron intake'}]",,0.0550242,Vegetable intake was higher in the MET group ( p  = 0.0001).,"[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Wessinger', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Hafer-Macko', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'S Ryan', 'Affiliation': 'VA Research Service, Department of Medicine, Division of Gerontology and Geriatric Medicine at the University of Maryland School of Medicine, and the Baltimore VA Medical Center Geriatric Research, Education and Clinical Center (GRECC), VA Maryland Health Care System, Baltimore, MD 21201, USA.'}]",Nutrients,['10.3390/nu12103059']
3284,33036537,[Effects of transcranial direct current stimulation on cognitive function in delayed encephalopathy after carbon monoxide poisoning].,"Objective:  To investigate the effect of transcranial direct current stimulation (tDCS) on cognitive function of delayed encephalopathy after carbon monoxide poisoning (DEACMP) .  Methods:  A total of 58 patients with DEACMP admitted to the Emergency Medicine Department of Hudson International Peace Hospital from January 2018 to January 2020 were included. According to the random number table, the patients were randomly divided into study group and control group, with 29 patients in each group. Patients in both groups were given nutritional nerve therapy, improved microcirculation, adrenal cortical hormone and other drugs, as well as hyperbaric oxygen and rehabilitation training, once per day. The study group was treated with tDCS (electrode pads were placed and current stimulation was given 30 min/time) 1/d on the basis of conventional treatment, while the control group was treated with tDCS pseudo stimulation (electrode pads were placed and current stimulation was given for 10 s) 1/d for 30 days consecutively. The auditory event-related potential P300 (ERP-P300) was tested before and 30 days after treatment, and the Mini-Mental State Examination (MMSE) scale, Barthel index (BI) and the National Institutes of Health Neurological Impairment score (NIHSS) were used to evaluate and analyze the patients.  Results:  There was no significant difference in scores between the two groups before treatment (all  P >0.05) . After 30 days of treatment, the MMSE score, orientation, memory, attention and computing power, and language ability of the study group were all higher than those of the control group, and the differences were statistically significant ( P <0.05) . 90 days after treatment, the BI of the study group was higher than that of the control group ( P <0.05) . After 30 days of treatment, the NIHSS score of the study group was significantly lower than that of the control group ( P <0.05) . The latency of ERP-P300 in the study group was shorter than that in the control group, and the amplitude was higher than that in the control group at 30 days after treatment, and the difference was statistically significant ( P <0.05) . The latency of ERP-P300 was negatively correlated with the total MMSE score before and after DEACMP treatment ( r =-0.837, -0.819,  P <0.05) . The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  Conclusion:  TDCS treatment can help improve the cognitive function of DEACMP patients, and ERP-P300 test can help determine the cognitive function severity of patients.",2020,"The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  ","['delayed encephalopathy after carbon monoxide poisoning', '58 patients with DEACMP admitted to the Emergency Medicine Department of Hudson International Peace Hospital from January 2018 to January 2020 were included', 'delayed encephalopathy after carbon monoxide poisoning (DEACMP) ']","['nutritional nerve therapy, improved microcirculation, adrenal cortical hormone and other drugs, as well as hyperbaric oxygen and rehabilitation training', 'TDCS', 'tDCS (electrode pads were placed and current stimulation was given 30 min/time', 'tDCS pseudo stimulation (electrode pads were placed and current stimulation', 'transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS']","['latency of ERP-P300', 'NIHSS score', 'Mini-Mental State Examination (MMSE) scale, Barthel index (BI) and the National Institutes of Health Neurological Impairment score (NIHSS', 'cognitive function', 'orientation, attention and computing power, and language ability', 'auditory event-related potential P300 (ERP-P300', 'MMSE score, orientation, memory, attention and computing power, and language ability', 'total MMSE score']","[{'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0007020', 'cui_str': 'Carbon monoxide poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0271276', 'cui_str': ""Stahli's line""}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205237', 'cui_str': 'False'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",58.0,0.0255641,"The latency of ERP-P300 was negatively correlated with orientation, attention and computing power, and language ability before treatment ( r =-0.698, -0.675, -0.742,  P <0.05) .  ","[{'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Cao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'B Y', 'Initials': 'BY', 'LastName': 'Zhu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Q M', 'Initials': 'QM', 'LastName': 'Xiao', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'W Z', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Du', 'Affiliation': 'Department of Emergency Medicine, Hudson International Peace Hospital, Hebei Medical University, Hengshui 053000, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20200224-00085']
3285,33036554,"Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial.","BACKGROUND


The optimal position for continuous adductor canal block (ACB) for analgesia after total knee anthroplasty (TKA) remians controversial, mainly due to high variability in the localization of the the adductor canal (AC). Latest neuroanatomy studies show that the nerve to vastus medialis plays an important role in innervating the anteromedial aspect of the knee and dives outside of the exact AC at the proximal end of the AC. Therefore, we hypothesized that continuous ACB at the proximal end of the exact AC could provide a better analgesic effect after TKA compared with that at the middle of the AC (which appeared to only block the saphenous nerve).
METHODS


Sixty-two adult patients who were scheduled for a unilateral TKA were randomized to receive continuous ACB at the proximal end or middle of the AC. All patients received patient-controlled intravenous analgesia with sufentanil postoperatively. The primary outcome measure was cumulative sufentanil consumption within 24 h after the surgery, which was analyzed using Mann-Whitney U tests. P-values < 0.05 (two-sided) were considered statistically significant. The secondary outcomes included postoperative sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
RESULTS


Sixty patients eventually completed the study (30/group). The 24-h sufentanil consumption was 0.22 μg/kg (interquartile range [IQR]: 0.15-0.40 μg/kg) and 0.39 μg/kg (IQR: 0.23-0.52 μg/kg) in the proximal end and middle groups (P = 0.026), respectively. There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
CONCLUSIONS


Continuous ACB at the proximal end of the AC has a better opioid-sparing effect without a significant influence on quadriceps motor strength compared to that at the middle of the AC after TKA. These findings indicates that a true ACB may not produce the effective analgesia, instead, the proximal end AC might be a more suitable block to alleviate pain after TKA.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov ( NCT03942133 ; registration date: May 06, 2019; enrollment date: May 11, 2019).",2020,"There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
","['Sixty patients eventually completed the study (30/group', 'Sixty-two adult patients who were scheduled for a unilateral TKA']","['continuous adductor canal block (ACB', 'continuous ACB']","['postoperative sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters', 'pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters', 'analgesic effect', 'cumulative sufentanil consumption', '24-h sufentanil consumption', 'quadriceps motor strength', 'sufentanil consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",62.0,0.473559,"There were no significant inter-group differences in sufentanil consumption at other time points, pain at rest and during passive knee flexion, quadriceps motor strength, and other recovery related paramaters.
","[{'ForeName': 'Yuda', 'Initials': 'Y', 'LastName': 'Fei', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xulei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China. cui.xulei@aliyun.com.'}, {'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Orthopaedic Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Anesthesiology Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Shuaifuyuan 1#, Dongcheng District, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01165-w']
3286,33036567,Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial.,"BACKGROUND


Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease.
METHODS


QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program.
DISCUSSION


The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life.
TRIAL REGISTRATION


This trial was registered in ClinicalTrials.gov since May 2017 ( NCT03169075 ).",2020,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"['metastatic cancer patients receiving oral targeted therapy', 'metastatic cancer patients', 'Patients (phase II: n\u2009=\u2009120; phase III: n\u2009=\u2009312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a', 'advanced cancer patients', 'patients with advanced disease']","['Physical exercise', 'supervised program', 'supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet', 'home-based physical exercise program', 'supervised home-based physical exercise program', 'first- or second-line oral targeted therapy without chemotherapy']","['fatigue and quality of life', 'general well-being and quality of life', 'Feasibility and efficacy', ""fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival"", 'quality of life']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.047477,Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients.,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Centre François Baclesse et CHU Côte de Nacre, Caen, France. f.joly@baclesse.unicancer.fr.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnier-Tixidre', 'Affiliation': 'Institut Daniel Hollard, Grenoble, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': 'HIA Begin, Saint Mandé, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Menneveau', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Zannetti', 'Affiliation': 'CH, Cholet, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'CHU La Timone, Marseille, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'Institut de Cancérologie du Gard, Nîmes, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Abadie-Lacourtoisie', 'Affiliation': 'ICO René Gauducheau, Nantes, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': 'CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Soazig', 'Initials': 'S', 'LastName': 'Nenan', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rieger', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Hôpital de l'Hôtel-Dieu, Paris, France.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Descotes', 'Affiliation': 'CAMI Sport et Cancer, Neuilly sur seine, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'CHRU de Besançon, Besançon, France.'}]",BMC cancer,['10.1186/s12885-020-07381-4']
3287,33036579,Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial.,"BACKGROUND


Patients with high-risk prostate cancer are at increased risk of lymph node metastasis and are thought to benefit from whole pelvis radiotherapy (WPRT). There has been recent interest in the use of hypofractionated radiotherapy in treating prostate cancer. However, toxicity and cancer outcomes associated with hypofractionated WPRT are unclear at this time. This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
METHODS


Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer will be randomized in a 1:1 ratio between high-dose-rate brachytherapy (HDR-BT) + conventionally fractionated (45 Gy in 25 fractions) WPRT vs. HDR-BT + hypofractionated (25 Gy in 5 fractions) WPRT. Randomization will be performed with a permuted block design without stratification. The primary endpoint is late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm.
DISCUSSION


To our knowledge, this is the first study to compare hypofractionated WPRT to conventionally fractionated WPRT with HDR-BT boost. Hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if demonstrated to be well-tolerated and effective.
TRIAL REGISTRATION


This trial was prospectively registered in ClinicalTrials.gov as NCT04197141 on December 12, 2019.",2020,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
","['Patients with high-risk prostate cancer', 'Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer', 'prostate cancer patients']","['hypofractionated whole pelvis radiotherapy (WPRT', 'whole pelvis radiotherapy (WPRT', 'hypofractionated WPRT', 'conventionally fractionated WPRT', 'high-dose-rate brachytherapy (HDR-BT)\u2009+\u2009conventionally fractionated (45\u2009Gy in 25 fractions) WPRT vs. HDR-BT\u2009+\u2009hypofractionated (25\u2009Gy in 5 fractions) WPRT', 'Hypofractionated WPRT', 'hypofractionated radiotherapy']","['late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm', 'toxicity and cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.108763,"This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT.
","[{'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada. lucascastromendez@gmail.com.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Arifin', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Bauman', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Vikram M', 'Initials': 'VM', 'LastName': 'Velker', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Ahmad', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Varagur M', 'Initials': 'VM', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Sexton', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Schaly', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': ""D'Souza"", 'Affiliation': 'Division of Radiation Oncology, London Regional Cancer Program, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.'}]",BMC cancer,['10.1186/s12885-020-07490-0']
3288,33038832,Effect of omega-3 lcpufa supplementation on maternal fatty acid and oxylipin concentrations during pregnancy.,"INTRODUCTION


Omega-3 long chain polyunsaturated fatty acids (LCPUFA) have been associated with a reduction in risk for preterm birth. However, there is limited understanding of how fatty acids and their bioactive derivatives (oxylipins) change over the course of pregnancy. Here we document the changes in concentration of fatty acids and oxylipins during pregnancy and how fatty acid status and oxylipin concentrations are affected by supplementation with omega-3 LCPUFA. We also investigate the degree to which fatty acid and oxylipin changes across pregnancy are influenced by baseline omega-3 status.
MATERIALS AND METHODS


We profiled the fatty acids in all lipids in dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins in separate dried blood spot samples by LC-MS-MS collected from a random sample of 1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial. ORIP is a double-blind, randomized controlled trial involving 5544 participants and designed to determine the effect of supplementing the diets of pregnant women with omega-3 LCPUFA on the incidence of early preterm birth. Maternal whole blood finger prick samples were collected at baseline (~14 weeks gestation) and at completion of the study intervention period (34 weeks gestation).
RESULTS


The concentration of most total and free polyunsaturated fatty acids and their associated oxylipins declined over the course of pregnancy. Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA. The intervention had minimal or no effect on free EPA, LA, AA and their associated oxylipins. Omega-3 LCPUFA supplementation in women with higher omega-3 status at baseline was associated with a significant increase in 7-HDHA and 4-HDHA between the treatment and control whereas there were no differences between groups in 7-HDHA and 4-HDHA in women with intermediate or lower baseline omega-3 status.
CONCLUSION


Our data suggest a differential response with or without omega-3 supplementation for DHA and DHA-derived oxylipins, which may have an important role to play in modulating pregnancy duration. Further work is needed to understand their role, which may allow us to better tailor omega-3 supplementation for preterm birth prevention.",2020,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","['5544 participants', '1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial', 'pregnant women with']","['Omega-3 long chain polyunsaturated fatty acids (LCPUFA', 'omega-3 lcpufa supplementation', 'omega-3 LCPUFA', 'dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins', 'ORIP', 'Omega-3 LCPUFA supplementation']","['incidence of early preterm birth', '7-HDHA and 4-HDHA', 'Maternal whole blood finger prick samples', 'total DHA and 7-HDHA', 'free EPA, LA, AA and their associated oxylipins', 'maternal fatty acid and oxylipin concentrations', 'concentration of most total and free polyunsaturated fatty acids']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",5544.0,0.103295,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA. Electronic address: karen.best@sahmri.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Agriculture, Food and Wine, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gomersall', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102181']
3289,33038833,"Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial.","BACKGROUND


Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation.
METHODS


This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
RESULTS


Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups.
CONCLUSION


In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).",2020,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","['cystic fibrosis patients', 'Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48', 'Cystic fibrosis (CF) patients', 'CF patients', 'CF patients (age >2 months']","['docosahexaenoic acid (DHA) supplementation', 'seaweed DHA oil solution', 'placebo', 'matching placebo', 'docosahexaenoic acid (DHA']","['serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers', 'pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life', 'pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036500', 'cui_str': 'Macroalgae'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",96.0,0.816089,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Neyra', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain. Electronic address: alneyra@salud.madrid.org.'}, {'ForeName': 'Lucrecia', 'Initials': 'L', 'LastName': 'Suárez', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Blas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz de Valbuena', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Garriga', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Endocrinología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Calvo', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ribes', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Girón Moreno', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario La Princesa. Instituto de Investigación Sanitaria La Princesa. Calle de Diego de León, 62. 28006-Madrid. Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Máiz', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'González', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Manzanares', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Doce de Octubre. Avda. de Córdoba. 28041-Madrid. Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Pastor', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Bioquímica Clínica, UCA-CCM. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Botas', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain; Servicio de Bioquímica-Investigación. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Del Campo', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cantón', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Garbiñe', 'Initials': 'G', 'LastName': 'Roy', 'Affiliation': 'Servicio de Inmunología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menacho', 'Affiliation': 'Servicio de Bioquímica Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario La Princesa. Universidad Autónoma de Madrid. Calle de Diego de León, 62. 28006-Madrid. Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Lamas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102186']
3290,33038899,Blood Biomarkers and 6- to 7-Year Childhood Outcomes Following Neonatal Encephalopathy.,"OBJECTIVE


This study aimed to profile the cytokine/chemokine response from day 0 to 7 in infants (≥36 weeks of gestational age) with neonatal encephalopathy (NE) and to explore the association with long-term outcomes.
STUDY DESIGN


This was a secondary study of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network randomized controlled trial of whole body hypothermia for NE. Eligible infants with moderate-severe NE were randomized to cooling or normothermia. Blood spots were collected on days 0 to 1, 2 to 4, and 6 to 7. Twenty-four cytokines/chemokines were measured using a multiplex platform. Surviving infants underwent neurodevelopmental assessment at 6 to 7 years. Primary outcome was death or moderate-severe impairment defined by any of the following: intelligence quotient <70, moderate-severe cerebral palsy (CP), blindness, hearing impairment, or epilepsy.
RESULTS


Cytokine blood spots were collected from 109 participants. In total 99 of 109 (91%) were assessed at 6 to 7 years; 54 of 99 (55%) developed death/impairment. Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment. Though TNF-α levels had no association with death/impairment, higher day 0 to 1 levels were observed among neonates who died/developed CP. On multiple regression analysis adjusted for center, treatment group, sex, race, and level of hypoxic ischemic encephalopathy, higher RANTES was inversely associated with death/impairment (odds ratio (OR): 0.31, 95% confidence interval [CI]: 0.13-0.74), while day seven MCP-1 level was directly associated with death/impairment (OR: 3.70, 95% CI: 1.42-9.61). Targeted cytokine/chemokine levels demonstrated little variation with hypothermia treatment.
CONCLUSION


RANTES and MCP-1 levels in the first week of life may provide potential targets for future therapies among neonates with encephalopathy.
KEY POINTS


· Elevation of specific cytokines and chemokines in neonates with encephalopathy has been noted along with increased risk of neurodevelopmental impairment in infancy.. · Cytokine/chemokines at <7 days were assessed among neonates in a trial of hypothermia for HIE.. · Neonates who died or were impaired at 6 to 7 years following hypoxic-ischemic encephalopathy had lower RANTES and higher MCP-1 levels than those who survived without impairment..",2020,Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment.,"['Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD', 'day 0 to 7 in infants (≥36 weeks of gestational age) with neonatal encephalopathy (NE', 'neonates with encephalopathy', 'Eligible infants with moderate-severe NE']",['cooling or normothermia'],"['monocyte chemotactic protein (MCP)-1 levels', 'death or moderate-severe impairment defined by any of the following: intelligence quotient <70, moderate-severe cerebral palsy (CP), blindness, hearing impairment, or epilepsy', 'MCP-1 levels', 'MCP-1 level', 'Blood spots', 'death/impairment']","[{'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0445103', 'cui_str': 'Normothermia'}]","[{'cui': 'C0282566', 'cui_str': 'Monocyte Chemotactic Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",109.0,0.246804,Neonates who died or were impaired had lower early regulated upon activation normal T cell expressed and secreted (RANTES) and higher day 7 monocyte chemotactic protein (MCP)-1 levels than neonates who survived without impairment.,"[{'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'McDonald', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': ""Department of Pediatrics, University of Alabama at Birmingham and Children's Hospital of Alabama, Birmingham, Alabama.""}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': ""Department of Pediatrics, Women & Infant's Hospital, Brown University, Providence, Rhode Island.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Skogstrand', 'Affiliation': 'Department for Congenital Disorders, Center for Neonatal Screening, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hougaard', 'Affiliation': 'Department for Congenital Disorders, Center for Neonatal Screening, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, Virginia.'}]",American journal of perinatology,['10.1055/s-0040-1717072']
3291,33038078,The Effect of Acupressure Applied to Individuals Receiving Hemodialysis Treatment on Severity of Thirst and Quality of Life.,"Objective


This study was conducted to determine the effect of acupressure on the severity of thirst and quality of life of patients receiving hemodialysis treatment.
Materials and Methods


This study was carried out in a randomized-controlled way to define the effect of acupressure performed on CV-23, SJ-17, Kid-1 acupuncture points for 15 min three times a week for six weeks on the intensity of thirst and quality of life in patients on hemodialysis. The second phase of the study was carried out as a qualitative study using an individual interview technique and a semi-structured questionnaire form before and after the acupressure with the intervention group patients in the study. The study was completed with 60 patients.
Results


The weekly increase in the amount of saliva and the weekly decrease in the Visüel Analog Scala (VAS)-VAS thirst level in the individuals in the intervention group compared to those in the placebo group were found to be significant (P < .05). In the 1st and the 6th week assessments the difference between the intervention group and the placebo group in terms the mental component sub-dimension of the Quality of Life scale was found to be significant (P < .05), but difference between all other sub-dimensions and total averagescores was not found to be significant (P < .05).
Conclusion


It was determined that acupressure applied to the CV-23, SJ-17, Kid-1 acupuncture points with an acupressure device increased the amount of saliva, decreased the severity of VAS thirst and affects positively of quality of life except the mental component sub-dimension.",2020,"In the 1st and the 6th week assessments the difference between the intervention group and the placebo group in terms the mental component sub-dimension of the Quality of Life scale was found to be significant (P < .05), but difference between all other sub-dimensions and total averagescores was not found to be significant (P < .05).
","['60 patients', 'patients on hemodialysis', 'patients receiving hemodialysis treatment']","['CV-23, SJ-17, Kid-1 acupuncture', 'Acupressure', 'acupressure', 'placebo']","['intensity of thirst and quality of life', 'mental component sub-dimension of the Quality of Life scale', 'Visüel Analog Scala (VAS)-VAS thirst level', 'severity of thirst and quality of life', 'Severity of Thirst and Quality of Life', 'amount of saliva']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",,0.0195877,"In the 1st and the 6th week assessments the difference between the intervention group and the placebo group in terms the mental component sub-dimension of the Quality of Life scale was found to be significant (P < .05), but difference between all other sub-dimensions and total averagescores was not found to be significant (P < .05).
","[{'ForeName': 'Alev', 'Initials': 'A', 'LastName': 'Yıldırım Keskin', 'Affiliation': ''}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Taşci', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3292,33038079,Pleiotropic Effects of Comarum palustre L. in Patients with Osteoarthritis and Diabetes Mellitus with High Comorbidity Burden: An Exploratory Study.,"Background


Patients with osteoarthritis (OA) and diabetes mellitus (DM) are at increased risk of polypharmacy. A potential approach to this group of patients could be the use of herbal treatments influencing multiple biological pathways and aiming simultaneously at both OA and related comorbid conditions. Comarum palustre L. is widely used in traditional medicine but there is a lack of studies evaluating its pleiotropic effects in OA and DM.
Primary Study Objective


To investigate pleiotropic effects of Comarum palustre L. in patients with OA and diabetes mellitus (DM).
Methods


This was open-label, single-arm exploratory study on patients with knee OA and DM.
Setting


Single-center study.
Participants


Fifteen adult patients (mean age 68.6 years, fourteen women, one man) with knee OA and DM.
Intervention


The patients received Comarum palustre L.tablets 500 mg twice daily for 28 days.
Primary Outcome Measure


Changes from baseline in Visual Analogue Scale (VAS) for Pain.
Results


At the end of treatment there were significant reductions in VAS pain (effect size (ES) 1.45, 95% confidence interval (CI) 0.61 to 2.3), OA symptoms (ES 1.1 95% CI (-1.9 to -0.29), and disability (ES -0.88 95% CI -1.66 to -0.09). Treatment with Comarum palustre L. resulted in decrease in total cholesterol (TC), cholesterol ratio, and an increase in HDL-C. There was decrease of circulating TNF-α concentrations, and increase in circulating IL-10 and adiponectin levels.
Conclusion


Treatment with Comarum palustre L.is associated with pleiotropic effects in patients with OA and comorbid DM. These results provide a rationale for larger randomized controlled studies.",2020,"Treatment with Comarum palustre L. resulted in decrease in total cholesterol (TC), cholesterol ratio, and an increase in HDL-C.","['patients with knee OA and DM', 'Participants\n\n\nFifteen adult patients (mean age 68.6 years, fourteen women, one man) with knee OA and DM', 'Patients with Osteoarthritis and Diabetes Mellitus with High Comorbidity Burden', '\n\n\nPatients with osteoarthritis (OA) and diabetes mellitus (DM', 'patients with OA and comorbid DM', 'patients with OA and diabetes mellitus (DM']","['Comarum palustre L', 'Comarum palustre L.tablets']","['pleiotropic effects', 'VAS pain (effect size (ES', 'Changes from baseline in Visual Analogue Scale (VAS) for Pain.\nResults', 'total cholesterol (TC), cholesterol ratio, and an increase in HDL-C', 'disability', 'circulating TNF-α concentrations', 'OA symptoms', 'circulating IL-10 and adiponectin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",15.0,0.0881033,"Treatment with Comarum palustre L. resulted in decrease in total cholesterol (TC), cholesterol ratio, and an increase in HDL-C.","[{'ForeName': 'Ivan V', 'Initials': 'IV', 'LastName': 'Shirinsky', 'Affiliation': ''}, {'ForeName': 'Natalia Y', 'Initials': 'NY', 'LastName': 'Kalinovskaya', 'Affiliation': ''}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Filatova', 'Affiliation': ''}, {'ForeName': 'Valery S', 'Initials': 'VS', 'LastName': 'Shirinsky', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3293,33038081,Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles.,"Context


It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16 mm diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them.
Objective


The study intended to compare the effects on an acupuncturist's blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters.
Design


We conducted a double-blind randomized trial.
Setting


The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan.
Participants


The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy.
Methods


The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student's dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions.
Primary Outcome Measures


After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter.
Results


Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist's confidence (P = .16). In 99% of the tests, the cue that contributed to the acupuncturist's guess was the feeling of the needle insertion.
Conclusion


These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn't significantly affect the acupuncturist's blinding.",2020,"Results


Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions.","['Participants', '20 healthy students, who were familiar with']","['Acupuncture, Moxibustion', 'acupuncture', 'acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy']","['diameters of DBNs', ""acupuncturist's confidence""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205309', 'cui_str': 'Known'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C1556023', 'cui_str': 'Acupuncturist'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",20.0,0.170058,"Results


Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions.","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yajima', 'Affiliation': ''}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': ''}, {'ForeName': 'Morihiro', 'Initials': 'M', 'LastName': 'Nasu', 'Affiliation': ''}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Nishiwaki', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kawase', 'Affiliation': ''}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Hiramatsu', 'Affiliation': ''}, {'ForeName': 'Ruka', 'Initials': 'R', 'LastName': 'Nobe', 'Affiliation': ''}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Schlaeger', 'Affiliation': ''}, {'ForeName': 'Nobuari', 'Initials': 'N', 'LastName': 'Takakura', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3294,33038249,"Human immunodeficiency virus type-1 Vpu inhibitor, BIT225, in combination with 3-drug antiretroviral therapy modulates inflammation and immune cells functions.","BIT225 is a first in class inhibitor of HIV-1 Vpu. A phase II trial enrolled 36 HIV-1-infected, treatment-naïve participants in Thailand to receive standard of care antiretroviral therapy (ART) Atripla®, with 100 mg or 200 mg of BIT225 or placebo for 12 weeks. Combined treatment with BIT225 and ART was found to be generally safe and well tolerated, with comparable antiviral efficacy to ART alone. The secondary endpoint sCD163, a marker of monocyte/macrophage inflammation, was noted to be significantly decreased in the BIT225 arm. Plasma derived activated CD4 + and CD8 + T cells, NK cells and IL-21 were increased in those treated with BIT225. These findings are consistent with inhibition of the known effects of HIV Vpu, and may reflect clinically important modulation of inflammatory and immune function. Further clinical study is planned to both confirm and extend these important findings in treatment naïve, and treatment experienced individuals.",2020,"Plasma derived activated CD4 + and CD8 + T cells, NK cells and IL-21 were increased in those treated with BIT225.","['A phase II trial enrolled 36 HIV-1-infected, treatment-naïve participants in Thailand to receive']","['BIT225 and ART', 'standard of care antiretroviral therapy (ART) Atripla®, with 100\xa0mg or 200\xa0mg of BIT225 or placebo']","['secondary endpoint sCD163, a marker of monocyte/macrophage inflammation', 'Plasma derived activated CD4 + and CD8 + T cells, NK cells and IL-21', 'safe and well tolerated']","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C3490984', 'cui_str': 'BIT225'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1724016', 'cui_str': 'Atripla'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0962190', 'cui_str': 'interleukin-21'}]",36.0,0.0787884,"Plasma derived activated CD4 + and CD8 + T cells, NK cells and IL-21 were increased in those treated with BIT225.","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Luscombe', 'Affiliation': 'Biotron Limited, North Ryde, Australia.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Avihingsanon', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sivaporn', 'Initials': 'S', 'LastName': 'Gatechompol', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Win Min', 'Initials': 'WM', 'LastName': 'Han', 'Affiliation': 'HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Ewart', 'Affiliation': 'Biotron Limited, North Ryde, Australia.'}, {'ForeName': 'Audrey S', 'Initials': 'AS', 'LastName': 'Thomson', 'Affiliation': 'Biotron Limited, North Ryde, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Biotron Limited, North Ryde, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Biotron Limited, North Ryde, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Murphy', 'Affiliation': 'Northwestern University, Chicago, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa635']
3295,33038262,Choir singing improves respiratory muscle strength and quality of life in patients with structural heart disease - HeartChoir: a randomised clinical trial.,"AIMS OF THE STUDY


Most patients with reduced exercise capacity and acquired or congenital structural heart disease also have a reduced respiratory muscle strength. The aim of this pilot study was to investigate whether choir singing in combination with respiratory muscle training positively influences respiratory muscle strength, exercise capacity and quality of life in this population.
METHODS


In this single-centre, randomised and open-label interventional study we compared respiratory muscle strength, exercise capacity and quality of life in patients with acquired or congenital structural heart disease who received either standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone. The primary endpoint was the difference in change in maximum inspiratory pressure (∆MIP%predicted). Secondary endpoints included the difference in change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score).
RESULTS


Overall 24 patients (mean age 65, standard deviation [SD] 19 years, 46% male) were randomised after exclusion. ∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks. ∆MEP%predicted and ∆MVO2%predicted did not differ between both groups (∆MEP%predicted &minus;3, SD 26% vs &minus;3, SD 16%; p = 1.0 and ∆MVO2%predicted 18, SD 12% vs 10, SD 15%; p = 0.2).
CONCLUSIONS


Choir singing in combination with respiratory muscle training improved respiratory muscle strength and quality of life in patients with structural heart disease and may therefore be valuable supplements in cardiac rehabilitation. (Clinical trial registration number: NCT03297918) &nbsp.",2020,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","['19 years, 46% male', 'patients with structural heart disease - HeartChoir', 'patients with acquired or congenital structural heart disease who received either', 'Overall 24 patients (mean age 65, standard deviation [SD', 'Most patients with reduced exercise capacity and acquired or congenital structural heart disease', 'patients with structural heart disease']","['Choir singing in combination with respiratory muscle training', 'standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone', 'choir singing in combination with respiratory muscle training', 'Choir singing']","['change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score', 'maximum inspiratory pressure (∆MIP%predicted', 'respiratory muscle strength and quality of life', '∆MEP%predicted and ∆MVO2%predicted', 'quality of life', 'respiratory muscle strength, exercise capacity and quality of life']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",,0.235722,"∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks.","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Ganzoni', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Ketina', 'Initials': 'K', 'LastName': 'Arslani', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Pfister', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freese', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strobel', 'Affiliation': 'Department of Pneumology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland / Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tobler', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20346']
3296,33038265,Comment on: Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy on the rate and severity of pancreatic fistula after pancreaticoduodenectomy.,,2020,,['pancreatic fistula after pancreaticoduodenectomy'],['pancreaticogastrostomy versus pancreaticojejunostomy'],[],"[{'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}]",[],,0.054815,,"[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bhoriwal', 'Affiliation': 'Surgical Oncology, All India Institute of Medical Sciences, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Surgical Oncology, All India Institute of Medical Sciences, India.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Surgical Oncology, All India Institute of Medical Sciences, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Surgical Oncology, All India Institute of Medical Sciences, India.'}]",The British journal of surgery,['10.1002/bjs.12045']
3297,33038289,Pharmacokinetics of Deutetrabenazine and Tetrabenazine: Dose Proportionality and Food Effect.,"Deutetrabenazine (Austedo, Teva), an approved treatment of chorea in Huntington's disease and tardive dyskinesia in adult patients, is a rationally designed deuterated form of tetrabenazine. Two studies assessed the pharmacokinetics and safety of deutetrabenazine compared with tetrabenazine, and the effects of food on absorption of the deuterated active metabolites, α-dihydrotetrabenazine (α-HTBZ) and β-dihydrotetrabenazine (β-HTBZ). One study was an open-label 2-part study in healthy volunteers; the first part included a crossover single dose of two 15 mg candidate deutetrabenazine formulations in fed and fasted states compared with tetrabenazine 25 mg in the fasted state, and the second part included single and repeated dosing of the commercial formulation of deutetrabenazine (7.5, 15, and 22.5 mg) compared with tetrabenazine 25 mg. The second study was an open-label 5-way crossover study in healthy volunteers (n = 32) to evaluate relative bioavailability of 4 dose levels of the commercial formulation of deutetrabenazine (6, 12, 18, and 24 mg) with a standard meal and 18 mg with a high-fat meal. Both studies confirmed longer half-lives for active metabolites and lower peak-to-trough fluctuations for the sum of the metabolites (total [α+β]-HTBZ) following deutetrabenazine compared with tetrabenazine (3- to 4-fold and 11-fold, respectively) in steady-state conditions. Deutetrabenazine doses estimated to provide total (α+β)-HTBZ exposure comparable to tetrabenazine 25 mg were 11.4-13.2 mg. Food had no effect on exposure to total (α+β)-HTBZ, as measured by AUC. Although the total (α+β)-HTBZ C max  of deutetrabenazine was increased by ≈50% in the presence of food, it remained lower than that of tetrabenazine.",2020,"Food had no effect on exposure to total (α+β)-HTBZ, as measured by AUC.","['healthy volunteers (n = 32', 'healthy volunteers']","['Deutetrabenazine and Tetrabenazine', 'tetrabenazine 25 mg', 'deutetrabenazine formulations', 'deutetrabenazine', 'standard meal and 18 mg with a high-fat meal', 'Deutetrabenazine', 'tetrabenazine', 'Deutetrabenazine (Austedo, Teva', 'α-dihydrotetrabenazine (α-HTBZ) and β-dihydrotetrabenazine (β-HTBZ']","['total (α+β)-HTBZ C max  of deutetrabenazine', 'pharmacokinetics and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4277781', 'cui_str': 'deutetrabenazine'}, {'cui': 'C0039623', 'cui_str': 'Tetrabenazine'}, {'cui': 'C1129826', 'cui_str': 'Tetrabenazine 25 MG'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4325360', 'cui_str': 'Austedo'}, {'cui': 'C0058123', 'cui_str': 'dihydrotetrabenazine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C4277781', 'cui_str': 'deutetrabenazine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0202512,"Food had no effect on exposure to total (α+β)-HTBZ, as measured by AUC.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Ratiopharm GmbH, Ulm, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stamler', 'Affiliation': 'Formerly of Teva Pharmaceutical Industries Ltd, currently Alterity Therapeutics Limited, Newark, California, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bradbury', 'Affiliation': 'Formerly of Teva Pharmaceutical Industries Ltd, currently Alterity Therapeutics Limited, Newark, California, USA.'}, {'ForeName': 'Pippa S', 'Initials': 'PS', 'LastName': 'Loupe', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hellriegel', 'Affiliation': 'Formerly of Teva Pharmaceuticals Ltd, currently Aclaris Therapeutics Inc., Wayne, Pennsylvania, USA.'}, {'ForeName': 'Donna S', 'Initials': 'DS', 'LastName': 'Cox', 'Affiliation': 'Formerly of Teva Pharmaceuticals Ltd, currently Pfizer Corporation, Norristown, Pennsylvania, USA.'}, {'ForeName': 'Juha-Matti', 'Initials': 'JM', 'LastName': 'Savola', 'Affiliation': 'Teva Pharmaceuticals International GmbH, Basel, Switzerland.'}, {'ForeName': 'Mark Forrest', 'Initials': 'MF', 'LastName': 'Gordon', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rabinovich-Guilatt', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Netanya, Israel.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.882']
3298,33038438,Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a multi-centre feasibility randomised controlled trial (COMPRESS-RCT).,"BACKGROUND


Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial.
METHODS


We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals.
RESULTS


Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5% to 61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9 - 74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days.
CONCLUSION


COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9 th  January 2017.",2020,Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients.,"['Most participants were male (n\u2009=\u200976, 59.8%) with a mean age of 72 (95% CI: 69.9 - 74.9) years', 'adults following an in-hospital cardiac arrest patients', 'hospital cardiac arrest patients in a non-shockable rhythm', 'Patients were enrolled under a model of deferred consent', 'Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm', '127 patients across five UK hospitals']","['Mechanical versus manual chest compressions', 'mechanical CPR']","['ROSC', 'Median arrest duration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",35.0,0.363067,Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients.,"[{'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. Electronic address: k.couper@warwick.ac.uk.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Emergency, Cardiovascular and Critical Care Research Group, Faculty of Health, Social Care and Education, Kingston University, London and St George's, University of London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Booth', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Devrell', 'Affiliation': 'Patient Research Ambassador.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Orriss', 'Affiliation': 'Patient Research Ambassador.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.09.033']
3299,33038494,Augmented medial rectus muscle recession versus medial rectus recession with posterior scleral fixation in partially accommodative esotropia: a randomized clinical trial.,"PURPOSE


To compare the postoperative alignment after medial rectus muscle posterior scleral fixation versus augmented recession in children with partially accommodative esotropia (PAET) without convergence excess.
METHODS


In this prospective study, 60 children with PAET without convergence excess were randomly assigned to either augmented medial rectus recession, based on the average of distance angle with correction and near angle without correction, or medial rectus recession, based on distance angle with correction, combined with posterior scleral fixation. The ductions, versions, angles of deviation, and difference between angles were analyzed before and 6 months after surgery. Complete success was defined as orthotropia to within 8 Δ  of esophoria/tropia for both distance and near, with spectacle correction, at 6 months. Patients who developed any exophoria/tropia with their original spectacles and needed reduction of their hyperopic correction to achieve successful outcome were defined as qualified successes.
RESULTS


Of the 60 children, 25 in the augmented group and 28 in the posterior fixation group completed follow-up. The mean age at surgery was 4.90 ± 2.34 years. The complete success rate was 48% and 64% in the augmented and posterior fixation groups, respectively (P = 0.15); the qualified success rate was 80% and 92.9%, respectively (P = 0.17). Success rate was significantly higher (P = 0.04) in the posterior fixation group (56%) than in the augmented group (18%) when the preoperative angle disparity was ≥20 Δ .
CONCLUSIONS


Medial rectus posterior scleral fixation can improve the success rate in PAET with large angle disparity.",2020,"Success rate was significantly higher (P = 0.04) in the posterior fixation group (56%) than in the augmented group (18%) when the preoperative angle disparity was ≥20 Δ .
","['60 children, 25 in the augmented group and 28 in the posterior fixation group completed follow-up', '60 children with PAET without convergence excess', 'The mean age at surgery was 4.90 ± 2.34 years', 'partially accommodative esotropia', 'children with partially accommodative esotropia (PAET) without convergence excess']","['Medial rectus posterior scleral fixation', 'medial rectus muscle posterior scleral fixation versus augmented recession', 'augmented medial rectus recession, based on the average of distance angle with correction and near angle without correction, or medial rectus recession, based on distance angle with correction, combined with posterior scleral fixation', 'medial rectus muscle recession versus medial rectus recession with posterior scleral fixation']","['Complete success', 'success rate', 'qualified success rate', 'Success rate', 'complete success rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0339630', 'cui_str': 'Partially accommodative esotropia'}, {'cui': 'C0271380', 'cui_str': 'Convergence excess'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0582820', 'cui_str': 'Medial rectus muscle structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0395295', 'cui_str': 'Medial rectus recession'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}]",60.0,0.0514397,"Success rate was significantly higher (P = 0.04) in the posterior fixation group (56%) than in the augmented group (18%) when the preoperative angle disparity was ≥20 Δ .
","[{'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Al-Hayouti', 'Affiliation': 'Cairo University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awadein', 'Affiliation': 'Cairo University Faculty of Medicine, Cairo, Egypt. Electronic address: ahmedawadein@yahoo.com.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Gawdat', 'Affiliation': 'Cairo University Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Elhilali', 'Affiliation': 'Cairo University Faculty of Medicine, Cairo, Egypt.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.05.015']
3300,33038500,A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective.
METHODS


This study is a randomized, prospective trial in four primary care offices that serve patients in rural areas. Subjects will receive standardized research BP measurements at baseline, 6 and 12 months. The primary outcome will be differences between the intervention and control group in mean systolic BP at 12 months. Secondary outcomes will include systolic BP at 6 months; diastolic BP at 6 and 12 months, number of medication changes and costs.
CONCLUSIONS


This study plans to enroll subjects through 2022, follow-up will be completed in 2023 and results will be available in 2024. This study will provide information on whether a combined approach using texting of home BP values and a pharmacist-based telehealth services can improve BP control.",2020,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","['patients in rural areas or for those who lack transportation', 'four primary care offices that serve patients in rural areas']",['pharmacist-based intervention'],"['systolic BP at 6\u202fmonths; diastolic BP at 6 and 12\u202fmonths, number of medication changes and costs', 'blood pressure (BP', 'mean systolic BP', 'BP management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}]",4.0,0.0842913,"BACKGROUND


New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation.","[{'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, USA. Electronic address: linnea-polgreen@uiowa.edu.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, USA; Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, College of Medicine, USA; Department of Epidemiology, College of Public Health, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Snyder', 'Affiliation': 'Department of Internal Medicine, College of Medicine, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Sewell', 'Affiliation': 'Department of Biostatistics, College of Public Health, USA.'}, {'ForeName': 'Emine O', 'Initials': 'EO', 'LastName': 'Bayman', 'Affiliation': 'Department of Biostatistics, College of Public Health, USA; Department of Anesthesia, College of Medicine, USA.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Francis', 'Affiliation': 'Department of Internal Medicine, College of Medicine, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, College of Medicine, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Finkelstein', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106169']
3301,33038501,Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer.,"Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes.",2020,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","['250 women', 'women with metastatic breast cancer who are experiencing fatigue interference', 'metastatic breast cancer', 'cancer patients', 'metastatic breast cancer patients', 'metastatic breast cancer and other advanced cancer populations']","['telephone-based ACT', 'Acceptance and Commitment Therapy (ACT', 'acceptance and commitment therapy', 'ACT intervention or an education/support control condition']","['sleep interference, engagement in daily activities, and quality of life', 'psychological flexibility', 'Fatigue interference with activities, mood, and cognition', 'fatigue interference']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",250.0,0.0784595,"In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients.","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mosher', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: cemosher@iupui.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Krueger', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: efkruege@iu.edu.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hirsh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN 46202, USA. Electronic address: athirsh@iupui.edu.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: kathmill@iu.edu.'}, {'ForeName': 'Tarah J', 'Initials': 'TJ', 'LastName': 'Ballinger', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: tarahb@iu.edu.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: astornio@iu.edu.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: bpschnei@iu.edu.'}, {'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'Newton', 'Affiliation': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana Cancer Pavilion, 535 Barnhill Drive, Suite 473, Indianapolis, IN 46202, USA. Electronic address: evnewton@iu.edu.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, 1111 Middle Drive, NU 340G, Indianapolis, IN 46202, USA. Electronic address: vchampio@iu.edu.'}, {'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Indiana University School of Medicine, Center for Health Services Research, Regenstrief Institute, 1101 W. 10(th) Street, Indianapolis, IN 46202, USA. Electronic address: sheljohn@iu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106168']
3302,33031652,Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.,"BACKGROUND


Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS


In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS


The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS


Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).",2020,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","['patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive', 'coronavirus disease 2019 ', 'Hospitalized Patients with Covid-19', 'patients hospitalized with Covid-19']","['hydroxychloroquine', 'hydroxychloroquine and 3155 to receive usual care', 'Hydroxychloroquine and chloroquine', 'Hydroxychloroquine', 'usual care']","['cardiac deaths', 'death', '28-day mortality', 'frequency of invasive mechanical ventilation or death', 'Death', 'incidence of new major cardiac arrhythmia', 'hospital alive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",1561.0,0.344094,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiselka', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jakki', 'Initials': 'J', 'LastName': 'Faccenda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022926']
3303,33031670,Is a Trial of Perioperative Cognitive Training to Prevent Early Postoperative Cognitive Decline Actually Feasible?,,2020,,[],['Perioperative Cognitive Training'],['Early Postoperative Cognitive Decline'],[],"[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",,0.0276795,,"[{'ForeName': 'Hilary P', 'Initials': 'HP', 'LastName': 'Grocott', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, hgrocott@sbgh.mb.ca Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephan K W', 'Initials': 'SKW', 'LastName': 'Schwarz', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004859']
3304,33031713,Magnetic Resonance Imaging-Guided Fibrosis Ablation for the Treatment of Atrial Fibrillation: The ALICIA Trial.,"Background  Myocardial fibrosis is key for atrial fibrillation (AF) maintenance. We aimed to test the efficacy of ablating cardiac magnetic resonance (CMR)-detected atrial fibrosis plus pulmonary vein isolation (PVI).  Methods  - This was an open label, parallel-group, randomized, controlled trial. Patients with symptomatic drug-refractory AF (paroxysmal and persistent) undergoing first or repeat ablation were randomized in a 1:1 basis to receive PVI plus CMR-guided fibrosis ablation (CMR group) or PVI alone (PVI-alone group). The primary endpoint was the rate of recurrence (>30 seconds) at 12 months of follow-up using a 12-lead ECG and Holter monitoring at 3, 6, and 12 months. The analysis was conducted by intention-to-treat.  Results  - In total, 155 patients (71% male, age 59±10, CHA2DS2-VASc 1.3±1.1, 54% Paroxysmal AF) were allocated to the PVI-alone group (N=76) or CMR group (N=79). First ablation was performed in 80% and 71% of patients in the PVI-alone and CMR groups, respectively. The mean atrial fibrosis burden was 12% (only 〜50% of patients had fibrosis outside the pulmonary vein area). 100% and 99% of patients received the assigned intervention in the PVI-alone and CMR group, respectively. The primary outcome was achieved in 21 patients (27.6%) in the PVI-alone group and 22 patients (27.8%) in the CMR group (odds ratio[OR]: 1.01, 95% confidence interval [CI] 0.50-2.04; p=0.976). There were no differences in the rate of adverse events (3 in the CMR group and 2 in the PVI-alone group; p=0.68).  Conclusions  - A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing AF ablation with low fibrosis burden.",2020,- A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing AF ablation with low fibrosis burden.,"['unselected population undergoing AF ablation with low fibrosis burden', '155 patients (71% male, age 59±10, CHA2DS2-VASc 1.3±1.1, 54% Paroxysmal AF', 'Atrial Fibrillation', 'Patients with symptomatic drug-refractory AF (paroxysmal and persistent) undergoing first or repeat ablation']","['PVI plus CMR-guided fibrosis ablation (CMR group) or PVI alone (PVI-alone group', 'Magnetic Resonance Imaging-Guided Fibrosis Ablation', 'ablating cardiac magnetic resonance (CMR)-detected atrial fibrosis plus pulmonary vein isolation (PVI', 'CMR', 'PVI-alone and CMR']","['mean atrial fibrosis burden', 'rate of recurrence', 'rate of adverse events']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.186259,- A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing AF ablation with low fibrosis burden.,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Bisbal', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona & Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Benito', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Teis', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alarcón', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Sarrias', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain.'}, {'ForeName': 'Gala', 'Initials': 'G', 'LastName': 'Caixal', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Villuendas', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain.'}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Garre', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Soto', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cozzari', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Guasch', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Juncà', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Prat-Gonzalez', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Rosario J', 'Initials': 'RJ', 'LastName': 'Perea', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Bazàn', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Tolosana', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Arbelo', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genis', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona & Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV) & Cardiovascular Institute, Hospital Clinic, University of Barcelona, Barcelona, Catalonia, Spain.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008707']
3305,33031736,"2-year remission of type 2 diabetes and pancreas morphology: a post-hoc analysis of the DiRECT open-label, cluster-randomised trial.","BACKGROUND


The pancreas is small and irregular in shape in people with type 2 diabetes. If these abnormalities are caused by the disease state itself rather than being a predisposing factor, remission of type 2 diabetes should restore normal pancreas morphology. The objective of this study was to determine whether changes in pancreas volume and shape occurred during 2 years of remission.
METHODS


For this post-hoc analysis, we included a subset of adult participants of the Diabetes Remission Clinical Trial (DiRECT), who had type 2 diabetes and were randomly assigned to a weight management intervention or routine diabetes management. Intervention group participants were categorised as responders (HbA 1c  <6·5% [48 mmol/mol] and fasting blood glucose <7·0 mmol/L, off all anti-diabetes medication) and non-responders, who were classified as remaining diabetic. Data on pancreas volume and irregularity of pancreas border at baseline, 5 months, 12 months, and 24 months after intervention were compared between responders and non-responders; additional comparisons were made between control group participants with type 2 diabetes and a non-diabetic comparator (NDC) group, who were matched to the intervention group by age, sex, and post-weight-loss weight, to determine the extent of any normalisation. We used a mixed-effects regression model based on repeated measures ANOVA with correction for potential confounding. Magnetic resonance techniques were employed to quantify pancreas volume, the irregularity of the pancreas borders, and intrapancreatic fat content. β-cell function and biomarkers of tissue growth were also measured.
FINDINGS


Between July 25, 2015, and Aug 5, 2016, 90 participants with type 2 diabetes in the DiRECT subset were randomly assigned to intervention (n=64) or control (n=26) and were assessed at baseline; a further 25 non-diabetic participants were enrolled into the NDC group. At baseline, mean pancreas volume was 61·7 cm 3  (SD 16·0) in all participants with type 2 diabetes and 79·8 cm 3  (14·3) in the NDC group (p<0·0001). At 24 months, pancreas volume had increased by 9·4 cm 3  (95% CI 6·1 to 12·8) in responders compared with 6·4 cm 3  (2·5 to 10·3) in non-responders (p=0·0008). Pancreas borders at baseline were more irregular in participants with type 2 diabetes than in the NDC group (fractal dimension 1·138 [SD 0·027] vs 1·097 [0·025]; p<0·0001) and had normalised by 24 months in responders only (1·099 [0·028]). Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
INTERPRETATION


These data show for the first time, to our knowledge, reversibility of the abnormal pancreas morphology of type 2 diabetes by weight loss-induced remission.
FUNDING


Diabetes UK.",2020,"Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
","['people with type 2 diabetes', 'Between July 25, 2015, and Aug 5, 2016, 90 participants with type', 'participants with type 2 diabetes than in the NDC group (fractal dimension', 'adult participants of the Diabetes Remission Clinical Trial (DiRECT), who had type 2 diabetes', '2 diabetes in the DiRECT subset were randomly assigned to intervention (n=64) or control (n=26) and were assessed at baseline; a further 25 non-diabetic participants were enrolled into the NDC group']",['weight management intervention or routine diabetes management'],"['pancreas volume and shape', 'mean pancreas volume', 'Intrapancreatic fat', '2-year remission', 'pancreas volume', 'β-cell function and biomarkers of tissue growth', 'pancreas volume and irregularity of pancreas border']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",90.0,0.0452818,"Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Electronic address: ahmad.al-mrabeh2@ncl.ac.uk.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James A M', 'Initials': 'JAM', 'LastName': 'Shaw', 'Affiliation': 'Regenerative Medicine, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30303-X']
3306,33031757,"Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial.","BACKGROUND


Cobitolimod is a topically administered, DNA-based oligonucleotide that activates Toll-like receptor 9 (TLR9), and previous research has shown clinical efficacy in patients with moderate-to-severe ulcerative colitis. Here we assessed the efficacy and safety of different dose regimens of cobitolimod for induction therapy in patients with moderate-to-severe, left-sided ulcerative colitis.
METHODS


CONDUCT was a randomised, double-blind, five-arm, placebo-controlled, dose-ranging phase 2b study that recruited patients with moderate-to-severe, left-sided ulcerative colitis, with inadequate response to conventional or biological therapies, from 91 hospitals or outpatient clinics in 12 European countries. Eligible patients had a Mayo score of 6-12 with a centrally read endoscopic subscore (modified to exclude friability from grade 1) of 2 or higher and no individual subscore of less than 1, and confirmation of left-sided disease. Patients were randomised (1:1:1:1:1; block size of ten) via a computer-generated schedule and centralised interactive voice and web response system to receive rectal enemas of cobitolimod at 31 mg, 125 mg, or 250 mg at weeks 0 and 3 (2 × 31 mg, 2 × 125 mg, and 2 × 250 mg groups), cobitolimod at 125 mg at weeks 0, 1, 2, and 3 (4 × 125 mg group), or placebo. Randomisation was stratified by current glucocorticosteroid and previous tumour necrosis factor inhibitor treatment. Patients and all study personnel were masked to treatment allocation. The primary endpoint was the proportion of patients achieving clinical remission (Mayo subscores for rectal bleeding of 0, for stool frequency of 0 or 1 [with ≥1-point decrease from baseline], and for endoscopy of 0 or 1 [excluding friability]) at week 6. The primary analysis (based on intention to treat) and safety analysis were done in all randomly assigned patients who received at least one dose of active study drug or placebo. In this exploratory study, statistical tests were one-sided; p values of less than 0·10 were regarded as statistically significant, with no adjustment for multiplicity. This study is registered with ClinicalTrials.gov, NCT03178669, and is completed; the results here represent the final analysis.
FINDINGS


213 patients were randomly assigned between June 30, 2017, and June 26, 2019. Of these, 211 patients received study treatment: 40 in the cobitolimod 2 × 31 mg group, 43 in the 2 × 125 mg group, 42 in the 4 × 125 mg group, 42 in the 2 × 250 mg group, and 44 in the placebo group. A greater proportion of patients were in clinical remission at week 6 in the cobitolimod 2 × 250 mg group than in the placebo group (nine [21%] of 42 patients vs three [7%] of 44; odds ratio [OR] 3·8 [80% CI 1·5-9·5]; one-sided p=0·025). We identified no significant difference in the proportion of patients with clinical remission in the cobitolimod 2 × 31 mg group (five [13%] of 40 patients; OR 2·0 [80% CI 0·7-5·5], p=0·18), 2 × 125 mg group (two [5%] of 43; 0·7 [0·2-2·2], p=0·66), or 4 × 125 mg (four [10%] of 42; 1·4 [0·5-3·9], p=0·33) compared with the placebo group. Treatment-emergent adverse events occurred in 21 (48%) patients in the placebo group, ten (25%) patients in the cobitolimod 2 × 31 mg group, 17 (40%) patients in the 2 × 125 mg group, 15 (36%) patients in the 4 × 125 mg group, and 18 (43%) patients in the 2 × 250 mg group. Severe adverse events occurred in eight (4%) of 211 patients (worsening of ulcerative colitis [seven patients] and abdominal hernia and wound dehiscence [one patient]). Ten patients (two [5%] in the placebo group, two [5%] in the cobitolimod 2 × 31 mg group, two [5%] in the 4 × 125 mg, and four [10%] in the 2 × 250 mg group) had a total of 13 serious adverse events; these were worsening of ulcerative colitis (eight events) and pruritus, rash, abdominal hernia, fascia dehiscence, and deep vein thrombosis (one event each). One patient in the placebo group died from total organ failure after receiving a colectomy for a serious adverse event of disease worsening.
INTERPRETATION


Two topical administrations of cobitolimod 250 mg were well tolerated and more effective than placebo in inducing clinical remission 6 weeks after the start of treatment. TLR9 activation is a promising novel therapeutic target in ulcerative colitis and warrants further testing, with phase 3 trials of cobitolimod planned.
FUNDING


InDex Pharmaceuticals.",2020,A greater proportion of patients were in clinical remission at week 6 in the cobitolimod 2 × 250 mg group than in the placebo group (nine [21%] of 42 patients vs three [7%] of 44; odds ratio [OR] 3·8 [80% CI 1·5-9·5]; one-sided p=0·025).,"['patients with moderate-to-severe, left-sided ulcerative colitis', '211 patients received study treatment: 40 in the', 'patients with moderate-to-severe ulcerative colitis', 'Eligible patients had a Mayo score of 6-12 with a centrally read endoscopic subscore (modified to exclude friability from grade 1) of 2 or higher and no individual subscore of less than 1, and confirmation of left-sided disease', 'recruited patients with moderate-to-severe, left-sided ulcerative colitis, with inadequate response to conventional or biological therapies, from 91 hospitals or outpatient clinics in 12 European countries', '213 patients were randomly assigned between June 30, 2017, and June 26, 2019']","['TLR9 activation', 'cobitolimod', 'placebo', 'computer-generated schedule and centralised interactive voice and web response system to receive rectal enemas of cobitolimod']","['abdominal hernia and wound dehiscence', 'total organ failure', 'efficacy and safety', 'Treatment-emergent adverse events', 'clinical remission', 'total of 13 serious adverse events', 'worsening of ulcerative colitis (eight events) and pruritus, rash, abdominal hernia, fascia dehiscence, and deep vein thrombosis', 'Severe adverse events', 'proportion of patients achieving clinical remission (Mayo subscores for rectal bleeding of 0, for stool frequency of 0 or 1 [with ≥1-point decrease from baseline], and for endoscopy of 0 or 1 [excluding friability', 'proportion of patients with clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332535', 'cui_str': 'Friability'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0963057', 'cui_str': 'CD289 Antigen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}]","[{'cui': 'C0178282', 'cui_str': 'Hernia of abdominal cavity'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332535', 'cui_str': 'Friability'}]",213.0,0.446751,A greater proportion of patients were in clinical remission at week 6 in the cobitolimod 2 × 250 mg group than in the placebo group (nine [21%] of 42 patients vs three [7%] of 44; odds ratio [OR] 3·8 [80% CI 1·5-9·5]; one-sided p=0·025).,"[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Atreya', 'Affiliation': 'Medical Clinic 1, Department of Medicine, University Hospital Erlangen, University of Erlangen-Nürnberg, Erlangen, Germany; Deutsches Zentrum Immuntherapie, Erlangen, Germany. Electronic address: raja.atreya@uk-erlangen.de.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology, Nancy University Hospital, Vandoeuvre-lès-Nancy, France; Inserm U1256 NGERE, Lorraine University, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Klymenko', 'Affiliation': 'Department of Faculty Surgery, Zaporizhzhia Medical University, Zaporizhzhi, Ukraine.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Augustyn', 'Affiliation': 'Centrum Medyczne Plejady, Krakow, Poland.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bakulin', 'Affiliation': 'Department of Propedeutics of Internal Diseases, Gastroenterology and Dietology, Mechnikov North-Western State Medical University, Saint-Petersburg, Russia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Slankamenac', 'Affiliation': 'Department of Gastroenterology, General Hospital, Zrenjanin, Serbia.'}, {'ForeName': 'Pal', 'Initials': 'P', 'LastName': 'Miheller', 'Affiliation': '1st Department of Surgery, Gastroenterology Unit, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Department of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hébuterne', 'Affiliation': ""Department of Gastroenterology and Clinical Nutrition, CHU de Nice and University Côte d'Azur, Nice, France.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Arnesson', 'Affiliation': 'InDex Pharmaceuticals, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Knittel', 'Affiliation': 'InDex Pharmaceuticals, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kowalski', 'Affiliation': 'JK Biostatistics, Stockholm, Sweden.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Medical Clinic 1, Department of Medicine, University Hospital Erlangen, University of Erlangen-Nürnberg, Erlangen, Germany; Deutsches Zentrum Immuntherapie, Erlangen, Germany.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30301-0']
3307,32790699,Replicating and extending the effects of auditory religious cues on dishonest behavior.,"Although scientists agree that replications are critical to the debate on the validity of religious priming research, religious priming replications are scarce. This paper attempts to replicate and extend previously observed effects of religious priming on ethical behavior. We test the effect of religious instrumental music on individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US. Participants were randomly assigned to listen to one of three musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game. Participants were asked to indicate which side of a vertically-bisected computer screen contained more dots and, in every trial, indicating that the right side of the screen had more dots earned participants the most money (irrespective of the number of dots). Therefore, participants were able to report dishonestly to earn more money. In agreement with previous research, we did not observe any main effects of condition. However, we were unable to replicate a moderating effect of self-reported religiosity on the effects of religious music on ethical behavior. Nevertheless, further analyses revealed moderating effects for ritual participation and declared religious affiliation congruent with the musical prime. That is, participants affiliated with a religious organization and taking part in rituals cheated significantly less than their peers when listening to religious music. We also observed significant differences in cheating behavior across samples. On average, US participants cheated the most and Czech participants cheated the least. We conclude that normative conduct is, in part, learned through active membership in religious communities and our findings provide further support for religious music as a subtle, moral cue.",2020,"On average, US participants cheated the most and Czech participants cheated the least.","[""individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US""]","['religious instrumental music', 'musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game', 'auditory religious cues']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",[],408.0,0.0394338,"On average, US participants cheated the most and Czech participants cheated the least.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Nichols', 'Affiliation': 'Questrom School of Business, Boston University, Boston, MA, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lang', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kavanagh', 'Affiliation': 'Institute of Cognitive & Evolutionary Anthropology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Kundt', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yamada', 'Affiliation': 'Department of Behavioral Science, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Mitkidis', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0237007']
3308,30734696,Effect Modification by Baseline Mortality in the MORDOR Azithromycin Trial.,"We examined whether baseline mortality risk, as a function of child age and site, modified the azithromycin mortality-reduction effect in the  Macrolide Oraux pour Réduire les Décès avec un Oeil sur la Résistance  (MORDOR) clinical trial. We used the Cox proportional hazards model with an interaction term. Three models were examined representing three sources for the baseline-risk covariate: two using sources external to MORDOR and the third leveraging data within MORDOR. All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality. Etiological and programmatic implications of these findings are discussed.",2020,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.",[],[],['baseline mortality'],[],[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0416482,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.","[{'ForeName': 'Assaf P', 'Initials': 'AP', 'LastName': 'Oron', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Burstein', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington.'}, {'ForeName': 'Laina D', 'Initials': 'LD', 'LastName': 'Mercer', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and the College of Medicine, University of Malawi, Blantyre.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'The London School of Tropical Hygiene and Medicine, London, United Kingdom.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-1004']
3309,31448953,Halo It's Meat! the Effect of the Vegetarian Label on Calorie Perception and Food Choices.,"In the last few years, vegetarian products have become a widespread dietary option in food industry to the point that large retail chains such as McDonald's has offered a vegetarian burger to their customers (e.g., the Grand Veggie). In the present research, two studies investigated the influence of a vegetarian label on calorie perception, frequency consumption and food choices. In the first study (N = 211) participants were randomly assigned to an experimental design 2 (burger type: Grand Veggie vs Big Mac). In the second study (N = 915), participants were either exposed to a similar burger labeled vegetarian or a meat-based. Both studies show that vegetarian products are perceived as being less caloric than their non-vegetarian equivalents. However, participants do not report more intention to eat more vegetarian products and do not lead to differences in menu composition.",2020,"However, participants do not report more intention to eat more vegetarian product and do not lead to differences in menu composition.",['In the first study (N\xa0=\xa0211) participants'],"['experimental design 2 (burger type: Grand Veggie vs Big Mac', 'Vegetarian Label']","['calorie perception, frequency consumption and food choices', 'Calorie Perception and Food Choices']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0452929', 'cui_str': 'Burger (substance)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0042441', 'cui_str': 'Vegetarians'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",915.0,0.0348516,"However, participants do not report more intention to eat more vegetarian product and do not lead to differences in menu composition.","[{'ForeName': 'Théo', 'Initials': 'T', 'LastName': 'Besson', 'Affiliation': 'Laboratoire Parisien de Psychologie Sociale, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Bouxom', 'Affiliation': 'Laboratoire Parisien de Psychologie Sociale, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Jaubert', 'Affiliation': 'Laboratoire Parisien de Psychologie Sociale, Université Paris Nanterre, Nanterre, France.'}]",Ecology of food and nutrition,['10.1080/03670244.2019.1652820']
3310,28858052,Resistance Training Status and Effectiveness of Low-Frequency Resistance Training on Upper-Body Strength and Power in Highly Trained Soccer Players.,"Hertzog, M, Rumpf, MC, and Hader, K. Resistance training status and effectiveness of low-frequency resistance training on upper-body strength and power in highly trained soccer players. J Strength Cond Res 34(4): 1032-1039, 2020-Soccer is classified as a contact/collision sport with many player-to-player duels. Winning these duels, shielding the ball or fending off an opponent requires upper-body strength and power. Therefore, this study aimed (a) to examine the time-related effect of an upper-body resistance training (RT) on maximal strength and power changes in highly trained soccer players and (b) to investigate if the RT status influences these changes throughout a competitive season. Twenty-eight soccer players participated in this study and were divided into an untrained group (UG) and a trained group (TG), according to their RT status. Both groups performed the same upper-body RT once a week, over 30 weeks. Maximal strength (1 repetition maximum [1RM]) and maximal power (MP) were assessed before, during, and after the competitive season. Both groups significantly improved 1RM and MP over the entire competitive season, with a moderate (TG, 13%) to very large (UG, 21%) magnitude in 1RM and with a small (TG, 8%) to moderate (UG, 13%) magnitude in MP. After the initial 10 weeks of RT, UG presented significant and slightly (1RM) to moderately (MP) greater improvements than TG. For all other time intervals, the between-groups' changes in 1RM were rated as similar. For the last 20 weeks of the RT, the change in MP was significantly lower for UG compared with TG. One upper-body RT session per week will provide sufficient stimulus to enable an almost certain improvement in strength and power throughout a competitive season for all players disregarding their initial RT status.",2020,"For the last 20 weeks of the RT, the change in MP was significantly lower for UG compared to TG.","['Twenty-eight soccer players', 'highly trained soccer players']","['low frequency resistance training', 'untrained (UG) and a trained (TG']","['Maximal strength (1RM) and maximal power (MP', '1RM and MP', '1RM', 'change in MP']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0117416,"For the last 20 weeks of the RT, the change in MP was significantly lower for UG compared to TG.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Hertzog', 'Affiliation': 'National Sports Medicine Program, Excellence in Football Project, Aspetar-Orthopedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Rumpf', 'Affiliation': 'National Sports Medicine Program, Excellence in Football Project, Aspetar-Orthopedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Hader', 'Affiliation': 'National Sports Medicine Program, Excellence in Football Project, Aspetar-Orthopedic and Sports Medicine Hospital, Doha, Qatar.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002202']
3311,30576857,Immediate haemodynamic impact response to a mini-fluid challenge is independent of fluid type: A post-hoc analysis of a randomised double blinded controlled trial.,,2019,,[],[],[],[],[],[],,0.761081,,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'Anaesthesia and intensive care department, hopitaux universitaires Paris-Sud, université Paris-Sud, université Paris-Saclay, hôpital De Bicêtre, assistance publique Hôpitaux de Paris, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France. Electronic address: Alexandre.Joosten@erasme.ulb.ac.be.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Delaporte', 'Affiliation': 'Department of anaesthesiology, CHU de Brugmann, Université Libre de Bruxelles, 4, place Van Gehuchten, 1020 Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van der Linden', 'Affiliation': 'Department of anaesthesiology, CHU de Brugmann, Université Libre de Bruxelles, 4, place Van Gehuchten, 1020 Brussels, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rinehart', 'Affiliation': 'Department of anaesthesiology and perioperative care, university of California Irvine, 101, the City Drive South, Orange, 92868 CA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hipszer', 'Affiliation': 'Edwards Lifesciences, 1, Edwards Way, Irvine, 92614 CA, USA.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2018.10.017']
3312,31167022,Families Improving Together (FIT) for weight loss: a resource for translation of a positive climate-based intervention into community settings.,"Climate-based weight loss interventions, or those that foster a nurturing family environment, address important ecological influences typically ignored by the traditional biomedical treatments. Promoting a climate characterized by positive communication, autonomy support, and parental warmth supports adolescents in making healthy behavioral changes. In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes. Although several programs have identified essential elements and established the evidence base for the efficacy of these interventions, few have offered resources for the translation of these constructs from theoretical concepts to tangible practice. This paper provides strategies and resources utilized in the Families Improving Together (FIT) for weight loss randomized controlled trial to create a warm, supportive climate characterized by positive communication within the parent-child relationship. Detailed descriptions of how Project FIT emphasized these constructs through facilitator training, intervention curriculum, and process evaluation are provided as a resource for clinical and community interventions. Researchers are encouraged to provide resources to promote translation of evidence-based interventions for programs aiming to utilize a positive climate-based family approach for lifestyle modification.",2020,"In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes.",[],[],[],[],[],[],,0.0428267,"In addition, encouraging these skills within the family may have additional benefits of improved family functioning and other mental and physical health outcomes.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Law', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX.'}, {'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Kipp', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC.'}]",Translational behavioral medicine,['10.1093/tbm/ibz020']
3313,3584203,The value of early mobilisation in the treatment of Colles' fractures.,"Unilateral Colles' fractures in 187 patients over the age of 55 years were studied in a randomised prospective trial: 97 fractures were minimally displaced and were treated either conventionally or in a crêpe bandage; 90 displaced Colles' fractures were reduced and of these 47 were treated conventionally while 43 were encouraged to mobilise the wrist in a cast which restricted extension. Early wrist movement hastened functional recovery and led to earlier resolution of wrist swelling. Discomfort was no greater than in patients who were treated conventionally. The bony deformity, which recurred irrespective of the method of treatment, was not adversely affected by early mobilisation.",1987,Discomfort was no greater than in patients who were treated conventionally.,"[""Unilateral Colles' fractures in 187 patients over the age of 55 years"", ""Colles' fractures""]",[],['Discomfort'],"[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}]",[],"[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",97.0,0.0177073,Discomfort was no greater than in patients who were treated conventionally.,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': ''}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Wray', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Gregg', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3314,31764095,HIV-1 genetic diversity to estimate time of infection and infer adherence to preexposure prophylaxis.,"OBJECTIVE


To estimate time of HIV infection in participants from the Bangkok Tenofovir Study (BTS) with daily oral tenofovir disoproxil fumarate (TDF) for preexposure prophylaxis (PrEP) and relate infection with adherence patterns.
DESIGN


We used the diversity structure of the virus population at the first HIV RNA-positive sample to estimate the date of infection, and mapped these estimates to medication diaries obtained under daily directly observed therapy (DOT).
METHODS


HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients. We generated 10-25 HIV env sequences from each participant by single genome amplification, and calculated time since infection (and 95% confidence interval) using Poisson models of early virus evolution. Study medication diaries obtained under daily DOT were then used to compute the number of missed TDF doses at the approximate date of infection.
RESULTS


Fifteen of the 17 PrEP breakthrough infections were successfully amplified. Of these, 13 were initiated by a single genetic variant and generated reliable estimates of time since infection (median = 47 [IQR = 35] days). Eleven of these 13 were under daily DOT at the estimated time of infection. Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
CONCLUSION


We estimated time of infection in participants from BTS and found several infections when high levels of adherence to TDF were reported. Our results suggest that the biological efficacy of daily TDF against parenteral HIV exposure is not 100%.",2019,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","['participants from the Bangkok Tenofovir Study (BTS) with', 'HIV genetic diversity was investigated in all 17 PrEP breakthrough infections and in 16 placebo recipients']","['daily oral tenofovir disoproxil fumarate (TDF', 'TDF']",[],"[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042333', 'cui_str': 'Genetic Diversity'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]",[],25.0,0.0747858,"Analysis of medication diaries in these 11 participants showed 100% adherence in five, 90-95% adherence in two, 55% adherence in one, and nonadherence in three.
","[{'ForeName': 'Olivia D', 'Initials': 'OD', 'LastName': 'Council', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ruone', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Mock', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Khalil', 'Affiliation': 'Quantitative Sciences and Data Management Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Curlin', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'McNicholl', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Heneine', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Leelawiwat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Kachit', 'Initials': 'K', 'LastName': 'Choopanya', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Suphak', 'Initials': 'S', 'LastName': 'Vanichseni', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Thitima', 'Initials': 'T', 'LastName': 'Cherdtrakulkiat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Rapeepan', 'Initials': 'R', 'LastName': 'Anekvorapong', 'Affiliation': 'Bangkok Tenofovir Study Group, Bangkok, Thailand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'José Gerardo', 'Initials': 'JG', 'LastName': 'García-Lerma', 'Affiliation': 'Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002390']
3315,31875256,Fluids affecting bladder urgency and lower urinary symptoms (FABULUS): methods and protocol for a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


We present the design of a randomized controlled trial, Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS), with the purpose of testing the common clinical advice of treating overactive bladder by eliminating potentially irritating beverages (PIBs) that are caffeinated, artificially sweetened, citric, or alcoholic. The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations. Secondary outcomes include change in urgency symptoms and volume per void.
METHODS


We report the methods for FABULUS and discuss how challenges presented in the literature and from a prior proof-of-concept feasibility trial are addressed by strengthening study design, procedures, and instruments. We introduce the concept of standardized automated tutorials for assisting participants in compliance from study start to finish. The tutorials contain a detailed explanation of the study, including tips for complying with the extensive diary requirements, and parallel tutorials to intervention and control groups for consistency in format and time of instructional content. The intervention tutorial on eliminating PIBs places emphasis on maintaining steady fluid intake volume, as fluctuations have been a confounder in prior work.
RESULTS


Study results promise to inform about both the tutorial approach and specific PIB reduction for effectively treating overactive bladder.
CONCLUSIONS


OAB can have a negative impact on quality of life, and current medical treatments carry costs and side-effect risks. If simple lifestyle changes can improve or prevent these bladder symptoms, multiple medical and public health advances could result.",2020,The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations.,[],[],"['quality of life', 'change in urgency symptoms and volume per void']",[],[],"[{'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.102426,The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations.,"[{'ForeName': 'Megan O', 'Initials': 'MO', 'LastName': 'Schimpf', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecology, University of Michigan, L4000 University Hospital South, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA. mschimpf@med.umich.edu.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecology, University of Michigan, L4000 University Hospital South, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04209-z']
3316,31545734,Application of a Novel Force-Field to Manipulate the Relationship Between Pelvis Motion and Step Width in Human Walking.,"Motion of the pelvis throughout a step predicts step width during human walking. This behavior is often considered an important component of ensuring bipedal stability, but can be disrupted in populations with neurological injuries. The purpose of this study was to determine whether a novel force-field that exerts mediolateral forces on the legs can manipulate the relationship between pelvis motion and step width, providing proof-of-concept for a future clinical intervention. We designed a force-field able to: 1) minimize the delivered mediolateral forces (Transparent mode); 2) apply mediolateral forces to assist the leg toward mechanically-appropriate step widths (Assistive mode); and 3) apply mediolateral forces to perturb the leg away from mechanically-appropriate step widths (Perturbing mode). Neurologically-intact participants were randomly assigned to either the Assistive group (n = 12) or Perturbing group (n = 12), and performed a series of walking trials in which they interfaced with the force-field. We quantified the step-by-step relationship between mediolateral pelvis displacement and step width using partial correlations. Walking in the Transparent force-field had a minimal effect on this relationship. However, force-field assistance directly strengthened the relationship between pelvis displacement and step width, whereas force-field perturbations weakened this relationship. Both assistance and perturbations were followed by short-lived effects during a wash-out period, in which the relationship between pelvis displacement and step width differed from the baseline value. The present results demonstrate that the link between pelvis motion and step width can be manipulated through mechanical means, which may be useful for retraining gait balance in clinical populations.",2019,"Neurologically-intact participants were randomly assigned to either the Assistive group (n=12) or Perturbing group (n=12), and performed a series of walking trials in which they interfaced with the force-field.","['human walking', 'Neurologically-intact participants']",['Assistive group (n=12) or Perturbing group'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0193791,"Neurologically-intact participants were randomly assigned to either the Assistive group (n=12) or Perturbing group (n=12), and performed a series of walking trials in which they interfaced with the force-field.","[{'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Heitkamp', 'Affiliation': ''}, {'ForeName': 'Katy H', 'Initials': 'KH', 'LastName': 'Stimpson', 'Affiliation': ''}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Dean', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2941372']
3317,31708457,"Letter to the Editor on ""Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study"".",,2019,,[],['platelet-rich plasma'],[],[],"[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]",[],,0.0230868,,"[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Dahmen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Liam D A', 'Initials': 'LDA', 'LastName': 'Paget', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands; Aspetar, Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands. Electronic address: g.m.kerkhoffs@amsterdamumc.nl.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.10.008']
3318,31653603,Lessons from the Established Status Epilepticus Treatment Trial.,"Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue ""Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures"".",2019,"The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE.",['patients aged 2\u202fyears and above with established convulsive SE'],"['benzodiazepine', 'valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]",[],,0.0900024,"The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE.","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Cock', 'Affiliation': ""St George's University of London and Atkinson Morley Regional Epilepsy Network, St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: hannahrc@sgul.ac.uk.""}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Coles', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Health System and the Department of Pediatrics and Emergency Medicine, School of Medicine and Health Sciences, George Washington University Washington, DC, USA.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Cloyd', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Fountain', 'Affiliation': 'Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Departments of Neurology, Pediatrics and Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': 'Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA; Department of Neuroscience (Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.04.049']
3319,32119586,"Letter by Tsuda Regarding Article, ""Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial"".",,2020,,"['2 Diabetes Mellitus and Coronary Artery Disease', 'Patients With Type']",['Empagliflozin'],['Left Ventricular Mass'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}]",,0.0397112,,"[{'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'Cardiovascular and Metabolic Research Center, Kansai University of Health Sciences, Osaka, Japan.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044977']
3320,32204165,The influence of expert patients on the increase of medication adherence among tuberculosis patients.,"OBJECTIVE


This study aims to analyze the relationship between the role of expert patients and medication adherence among tuberculosis patients.
METHOD


The research was conducted as a quasi-experiment with control. There were 34 samples selected using the probability sampling technique.
RESULTS


The data were analyzed statistically using the Wilcoxon test and paired t-test. The results reveal that there was a change in knowledge and adherence before and after health education in the intervention and control groups. However, only the intervention group experienced a significant change with p<0.05, while in the control group, the change was not significant with p>0.05.
CONCLUSION


This study showed that there was a significant change in the mean of knowledge and adherence before and after health education by expert patients in the intervention group.",2020,The results reveal that there was a change in knowledge and adherence before and after health education in the intervention and control groups.,['tuberculosis patients'],[],"['mean of knowledge and adherence', 'medication adherence', 'knowledge and adherence']","[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",,0.0162438,The results reveal that there was a change in knowledge and adherence before and after health education in the intervention and control groups.,"[{'ForeName': '', 'Initials': '', 'LastName': 'Ernawati', 'Affiliation': 'STIKES Tanawali Persada Takalar, Indonesia.'}, {'ForeName': 'Ariyanti', 'Initials': 'A', 'LastName': 'Saleh', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Indonesia. Electronic address: yantie_nersuh@yahoo.com.'}, {'ForeName': 'Syahrir A', 'Initials': 'SA', 'LastName': 'Pasinringi', 'Affiliation': 'Faculty of Public Health, Hasanuddin University, Indonesia.'}, {'ForeName': 'Eva Arna', 'Initials': 'EA', 'LastName': 'Abrar', 'Affiliation': 'STIKES Nani Hasanuddin Makassar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.07.103']
3321,13482765,Placebo.,,1957,,[],['Placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.303013,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'STANOJEVIC', 'Affiliation': ''}]",Medicinski glasnik,[]
3322,1388172,Lack of scientific evidence for the treatment of lateral epicondylitis of the elbow. An attempted meta-analysis.,"We have reviewed 185 articles published since 1966 to assess the scientific evidence for methods of treatment for lateral epicondylitis of the elbow. Of the 185 articles, 78 discussed treatment, but since the natural history of the syndrome is uncertain we considered only those series with concurrent control groups. Only 18 of these were randomised and controlled studies. We then graded these papers for scientific validity, using the methods of Chalmers et al (1981). The mean score of the 18 articles was only 33%, with a range from 6% to 73%. A minimum of 70% is required for a valid clinical trial, and we therefore concluded that there was insufficient scientific evidence to support any of the current methods of treatment. There were too many methodological differences to allow a quantitative meta-analysis, but our qualitative review established the importance of the natural evolution of the syndrome and of the placebo effect of all treatments. Properly designed, controlled trials are needed.",1992,We have reviewed 185 articles published since 1966 to assess the scientific evidence for methods of treatment for lateral epicondylitis of the elbow.,['lateral epicondylitis of the elbow'],[],[],"[{'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]",[],[],,0.0954158,We have reviewed 185 articles published since 1966 to assess the scientific evidence for methods of treatment for lateral epicondylitis of the elbow.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Labelle', 'Affiliation': 'University of Montreal, Quebec, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Guibert', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Joncas', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fallaha', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Rivard', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3323,31391223,"Efficacy and safety of ralinepag, a novel oral IP agonist, in PAH patients on mono or dual background therapy: results from a phase 2 randomised, parallel group, placebo-controlled trial.","PURPOSE


This phase 2 study was designed to assess the efficacy, safety and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor agonist with a 24-h terminal half-life, compared to placebo in adult patients with symptomatic pulmonary arterial hypertension (PAH).
METHODS


61 PAH patients who were receiving standard care, including mono or dual PAH-targeted background therapy were randomised 2:1 to ralinepag (n=40) or placebo (n=21). The starting dose of ralinepag was 10 μg twice daily. Dosage was then up-titrated as tolerated over the course of the 9-week dose-titration period, to a maximum total daily dose of 600 μg (300 μg twice daily). The primary efficacy end-point was the absolute change in pulmonary vascular resistance (PVR) from baseline to week 22. Additional end-points included percentage change in PVR from baseline, other haemodynamic parameters, 6-min walk distance (6MWD) and safety and tolerability.
RESULTS


Ralinepag significantly decreased PVR by 163.9 dyn·s·cm -5  compared to an increase of 0.7 dyn·s·cm -5  with placebo (p=0.02); the least-squares mean change from baseline PVR was -29.8% compared with placebo (p=0.03). 6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90). Serious adverse events occurred in 10% of ralinepag patients and 29% of placebo patients. Study discontinuations occurred in 13% of ralinepag patients and 10% of placebo patients.
SUMMARY


Ralinepag reduced PVR compared with placebo in PAH patients on mono (41%) or dual combination (59%) background therapy.",2019,6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90).,"['Sixty-one PAH patients who were receiving standard of care, including mono or dual PAH -targeted background therapy', 'adult patients with symptomatic pulmonary arterial hypertension (PAH']","['ralinepag', 'placebo', 'immediate-release (IR) orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor (IP) agonist']","['efficacy, safety and tolerability', '6MWD', 'PVR', 'percentage change in PVR from baseline, other hemodynamic parameters, 6-minute walk distance (6MWD), and safety and tolerability', 'absolute change in pulmonary vascular resistance (PVR', 'Efficacy and safety', 'Serious adverse events']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C4508023', 'cui_str': '2-((4-(((4-chlorophenyl)(phenyl)carbamoyl)oxy)methyl)cyclohexyl)methoxy)acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0033554', 'cui_str': 'Prostanoids'}, {'cui': 'C4521473', 'cui_str': 'Prostacyclin receptor agonist'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.618949,6MWD increased from baseline by 36.2 m with ralinepag and 29.4 m with placebo (p=0.90).,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Pulmonary/Critical Care, UT Southwestern Medical Center, William P. Clements Jr University Hospital, Dallas, TX, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Farber', 'Affiliation': 'Pulmonary and Critical Care, Boston Medical Center, Boston University, Boston, MA, USA.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ristic', 'Affiliation': 'Dept of Cardiology, Clinical Center of Serbia and Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Vallerie', 'Initials': 'V', 'LastName': 'McLaughlin', 'Affiliation': 'Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Preston', 'Initials': 'P', 'LastName': 'Klassen', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Shanahan', 'Affiliation': 'Hessian Pharmaceuticals, Hayward, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grundy', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Hoffmann', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabell', 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escribano Subías', 'Affiliation': 'Dept of Cardiology, Hospital Universitario 12 de Octubre, Complutense University, Madrid, Spain.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'University of Texas, Houston, TX, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Keogh', 'Affiliation': ""Heart Transplant, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Gwyn', 'Initials': 'G', 'LastName': ""D'Souza"", 'Affiliation': 'Arena Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego, CA, USA ljrubin@ucsd.edu.'}]",The European respiratory journal,['10.1183/13993003.01030-2019']
3324,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
3325,32113192,Bubble-positive expiratory pressure device and sputum clearance in bronchiectasis: A randomised cross-over study.,"OBJECTIVES


The bubble-positive expiratory pressure (PEP) device may be used for sputum clearance in people with daily sputum production. However, this device has never been studied in people with bronchiectasis. Hence, the objective of this study was to compare the effect of bubble-PEP device, the active cycle of breathing technique (ACBT) and no intervention (control) on sputum clearance in people with bronchiectasis.
METHODS


This was a prospective, randomised cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis. Adult participants with stable bronchiectasis and productive of sputum daily were recruited. Participants performed 30-min of bubble-PEP, ACBT or control in random order whilst sitting, followed by 60-min of quiet sitting, on three separate days at the same time within a 10-day period. Primary outcome measure was wet weight of expectorated sputum during 30-min intervention, 60-min post intervention and total wet weight (30 min plus 60 min).
RESULTS


Thirty-five-participants (11 males, mean [standard deviation] age 75 [8] years, forced expiratory volume in 1 s 72 [20] % predicted) were recruited and 34 completed the study. There was no significant difference in sputum wet weight between bubble-PEP and ACBT during 30-min intervention (mean difference [95% confidence interval]) -0.59 g [-1.37, 0.19] and total wet weight (0.74 g [-0.54, 2.02]). Sputum wet weight was significantly greater in bubble-PEP than ACBT at 60-min post intervention (1.33 g [0.19, 2.47]).
CONCLUSION


Sputum wet weight was significantly greater with bubble-PEP than control at all time periods, and greater than ACBT at 60-min-post. Bubble-PEP could be considered an alternative sputum clearance technique to ACBT.",2020,"Sputum wet weight was significantly greater in bubble-PEP than ACBT at 60-min post intervention (1.33 g [0.19, 2.47]).
","['Adult participants with stable bronchiectasis and productive of sputum daily were recruited', 'bronchiectasis', 'Thirty-five-participants (11 males, mean [standard deviation] age 75 [8', 'people with bronchiectasis', 'years, forced expiratory volume in 1 s 72 [20] % predicted) were recruited and 34 completed the study', 'people with daily sputum production']","['bubble-PEP, ACBT or control in random order whilst sitting, followed by 60-min of quiet sitting', 'bubble-PEP device, the active cycle of breathing technique (ACBT) and no intervention (control', 'Bubble-positive expiratory pressure device']","['total wet weight', 'Sputum wet weight', 'sputum clearance', 'sputum wet weight', 'wet weight of expectorated sputum during 30-min intervention, 60-min post intervention and total wet weight (30 min plus 60 min']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033268'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0454503', 'cui_str': 'Active cycle of breathing technique (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0454505', 'cui_str': 'Sputum induction technique (regime/therapy)'}, {'cui': 'C0566528', 'cui_str': 'Does spit (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",,0.173446,"Sputum wet weight was significantly greater in bubble-PEP than ACBT at 60-min post intervention (1.33 g [0.19, 2.47]).
","[{'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Santos', 'Affiliation': 'Physiotherapy Department, Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Maree A', 'Initials': 'MA', 'LastName': 'Milross', 'Affiliation': 'Faculty of Health Sciences, Discipline of Physiotherapy, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'McKenzie', 'Affiliation': 'Respiratory and Sleep Medicine Department, Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Alison', 'Affiliation': 'Faculty of Health Sciences, Discipline of Physiotherapy, The University of Sydney, Lidcombe, New South Wales, Australia.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1836']
3326,32270482,The PANSAID randomized clinical trial: A pre-planned 1-year follow-up regarding harm.,"BACKGROUND


Limiting harm from postoperative pain treatment is important. However, long-term follow-up from acute pain trials are rare. The aim of the study was to provide long-term follow-up data regarding harm from the ""Paracetamol and Ibuprofen in Combination"" (PANSAID) trial.
METHODS


In this preplanned long-term follow-up study from the PANSAID trial, we used data from Danish national health registries (the Danish National Patient Registry and the Danish Civil Registration System) in addition to the 90-day follow-up in the original trial. The primary outcome was 1-year proportion of patients with one or more serious adverse events.
RESULTS


One-year follow-up was complete for 551 patients (99%). We found three additional patients with one or more serious adverse events in the 1-year follow-up compared with the 90-day follow-up. The relative risk of having one or more serious adverse event when randomized to ibuprofen compared with paracetamol was 1.40 (95% CI: 0.84-2.33, P = .20).
CONCLUSION


We found no statistically significant difference in 1-year serious adverse events between patients randomized to ibuprofen compared with paracetamol in patients having planned primary total hip arthroplasty. There were few additional events from the 90-day follow-up to the 1-year follow-up.",2020,"No difference in serious adverse events between the 2 treatments, paracetamol vs ibuprofen, were observed at 1 year after surgery.","['patients having planned primary total hip arthroplasty', 'acute pain management after total hip replacement surgery']","['ibuprofen', 'paracetamol vs ibuprofen', 'paracetamol', 'Paracetamol and Ibuprofen']","['1-year proportion of patients with one or more serious adverse events', '1-year serious adverse events', 'serious adverse events']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.13119,"No difference in serious adverse events between the 2 treatments, paracetamol vs ibuprofen, were observed at 1 year after surgery.","[{'ForeName': 'Kasper H', 'Initials': 'KH', 'LastName': 'Thybo', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Dpt. 7812, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology Orthopedic Research Unit, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13597']
3327,32067629,"Impact of Biannual Azithromycin on Anemia in Preschool Children in Kilosa District, Tanzania: A Cluster-Randomized Clinical Trial.","A cluster-randomized clinical trial showed that biannual single-dose azithromycin reduced mortality in preschool children; we sought to determine the effect on anemia. A simple random sample of 30 communities from Kilosa district, Tanzania, were themselves randomized to receive either 6-monthly treatment of children aged 1-59 months with single-dose azithromycin or placebo. From each community, 40 preschool children were randomly selected at baseline, 12 months, and 24 months. At surveys, the children underwent hemoglobin testing; WHO definitions for anemia were applied. After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months. In each of the cross-sectional surveys, anemia prevalence was associated with younger age; the odds of being anemic was highest in those aged < 12 months. There was also a general decrease in the prevalence of anemia during the study. Although azithromycin was not shown to affect anemia, significantly, the study highlights burden of anemia in rural, African communities.",2020,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","['Preschool Children in Kilosa District, Tanzania', '40 preschool children', '30 communities from Kilosa district, Tanzania', 'preschool children']","['azithromycin or placebo', 'Biannual Azithromycin', 'azithromycin']","['prevalence of anemia', 'anemia prevalence']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",40.0,0.144766,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0500']
3328,32124462,Learned pacing for adults with chronic pain: A randomised controlled trial feasibility study.,"INTRODUCTION


Chronic pain can significantly impact on an individual's occupational performance and quality of life. Pacing is a pain management strategy regularly used in occupational therapy practice; however, evidence for its effectiveness has not been established.
OBJECTIVES


To determine the feasibility of a future randomised controlled trial to investigate the effectiveness of a learned pacing intervention on occupational performance and satisfaction for adults with chronic pain.
METHODS


A randomised controlled trial feasibility study was conducted with participants randomly assigned to a learned pacing intervention or a waitlist control group. The primary outcome measure was the Canadian Occupational Performance Measure.
RESULTS


One hundred and twenty-eight people were screened for eligibility over 36 weeks, with 74 people invited to participate. Twelve were randomly assigned, eight to the learned pacing group and four to the control group. Those receiving the learned pacing intervention had clinically important changes in occupational performance and occupational satisfaction. Participants in the waitlist control group also had clinically important changes in occupational satisfaction. The method design was deemed feasible; however, several improvements would increase the rate of participant recruitment and reduce attrition. Recruitment from multiple sites is required to obtain an adequate sample size of 60.
CONCLUSION


Undertaking a future randomised controlled trial is feasible and warranted to establish the effectiveness of a learned pacing intervention on occupational performance and satisfaction for adults with chronic pain.",2020,Participants in the waitlist control group also had clinically important changes in occupational satisfaction.,"['One hundred and twenty-eight people were screened for eligibility over 36\xa0weeks, with 74 people invited to participate', 'adults with chronic pain']","['waitlist control group', 'learned pacing intervention', 'Learned pacing']","['occupational performance and occupational satisfaction', 'occupational satisfaction', 'rate of participant recruitment and reduce attrition', 'Canadian Occupational Performance Measure', 'occupational performance and satisfaction']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}]",128.0,0.14664,Participants in the waitlist control group also had clinically important changes in occupational satisfaction.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Guy', 'Affiliation': 'Community Based Rehabilitation Department, Western Health, St. Albans, Vic., Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'McKinstry', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Flora Hill, Vic., Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bruce', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Vic., Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12653']
3329,30935897,Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial.,"BACKGROUND


Prophylactic vasopressors are fundamental during caesarean delivery under spinal anaesthesia. The aim of this work is to compare the efficacy and safety of phenylephrine and norepinephrine when used in variable infusion rate during caesarean delivery.
METHODS


A randomised, double-blinded, controlled trial was conducted including mothers scheduled for elective caesarean delivery under spinal anaesthesia. Participants were allocated to two groups norepinephrine group (n = 60), and phenylephrine group (n = 63). Participants received prophylactic vasopressors after spinal block at rate started at 0.05 mcg/kg/min and 0.75 mcg/kg/min respectively. The rate of vasopressor infusion was manually adjusted according to maternal systolic blood pressure. Both groups were compared according to incidence of post-spinal hypotension (the primary outcome), incidence of bradycardia, incidence of reactive hypertension, systolic blood pressure, heart rate, rescue vasopressor consumption, number of physician interventions, and neonatal outcomes.
RESULTS


One hundred and twenty-three mothers were available for final analysis. Both groups were comparable in the incidence of post-spinal hypotension (32% versus 30%, P = 0.8). The number of physician intervention was lower in norepinephrine group. The incidence of bradycardia and the incidence of reactive hypertension were potentially lower in norepinephrine group without reaching statistical significance, (13% vs. 21%, P = 0.3) and (12% vs. 24%, P = 0.1). Rescue vasopressor consumption, and neonatal outcomes were comparable between both groups.
CONCLUSION


When given in a manually adjusted infusion, norepinephrine effectively maintained maternal SBP during caesarean delivery under spinal anaesthesia with lower number of physician interventions, and likely less incidence of reactive hypertension and bradycardia compared to phenylephrine.",2019,"Both groups were comparable in the incidence of post-spinal hypotension (32% versus 30%, P = 0.8).","['mothers scheduled for elective caesarean delivery under spinal anaesthesia', 'One hundred and twenty-three mothers were available for final analysis', 'prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery']","['Norepinephrine', 'norepinephrine', 'phenylephrine and norepinephrine', 'phenylephrine']","['incidence of bradycardia and the incidence of reactive hypertension', 'number of physician intervention', 'incidence of bradycardia, incidence of reactive hypertension, systolic blood pressure, heart rate, rescue vasopressor consumption, number of physician interventions, and neonatal outcomes', 'rate of vasopressor infusion', 'Rescue vasopressor consumption, and neonatal outcomes', 'reactive hypertension and bradycardia', 'efficacy and safety', 'maternal systolic blood pressure', 'incidence of post-spinal hypotension']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",123.0,0.156483,"Both groups were comparable in the incidence of post-spinal hypotension (32% versus 30%, P = 0.8).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: ahmedmohamedhasanin@gmail.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: sarahamin_22@hotmail.com.'}, {'ForeName': 'Sherin', 'Initials': 'S', 'LastName': 'Refaat', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: sherin.refaat@hotmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Habib', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: sara.farouk2020@cu.edu.eg.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Zayed', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: marwa.zayed@kasralainy.edu.eg.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Abdelwahab', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: yaserabdelwahab@gmail.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsayad', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: mssayad@hotmail.com.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: maha.mostafa@cu.edu.eg.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Raafat', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: mazenheba82@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elshall', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo university, Cairo, Egypt. Electronic address: dr.ahmedelshall@gmail.com.'}, {'ForeName': 'Shimaa Abd El', 'Initials': 'SAE', 'LastName': 'Fatah', 'Affiliation': 'Department of obstetrics and gynaecology, Cairo university, Cairo, Egypt. Electronic address: shimaa.mostafa@kasralainy.edu.eg.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2019.03.005']
3330,32112353,Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation.,"Allogeneic hematopoietic cell transplantation (alloHCT) is a life-saving technology that can cure otherwise incurable diseases, but imposes significant physiologic stress upon recipients. This stress leads to short-term toxicity and mid- to long-term physical function impairment in some recipients. Exercise interventions have demonstrated preliminary efficacy in preserving physical function in HCT recipients, but the role of these interventions prior to HCT (prehabilitative) is less known. We tested a 5- to 12-week, prehabilitative higher intensity home-based aerobic exercise intervention in a randomized study of alloHCT candidates. Of 113 patients screened, 34 were randomized to control or intervention groups, 16 underwent pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention 6-min walk distance (6MWD) testing. No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention. We conclude that the design of our prehabilitative intervention was not feasible in this pilot randomized study, and make recommendations regarding the design of future exercise intervention studies in alloHCT.",2020,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","['113 patients screened, 34 were randomized to control or intervention groups, 16 underwent']","['home-based exercise prescription before allogeneic hematopoietic cell transplantation', 'prehabilitative higher intensity home-based aerobic exercise intervention', 'pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention', 'Allogeneic hematopoietic cell transplantation (alloHCT', 'Exercise interventions']","['6-min walk distance (6MWD', 'VO 2peak  or 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",34.0,0.0488959,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wawood@med.unc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Battaglini', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05369-1']
3331,31219771,Sex differences in blood pressure regulation during ischemic isometric exercise: the role of the β-adrenergic receptors.,"We sought to investigate whether the β-adrenergic receptors play a pivotal role in sex-related differences in arterial blood pressure (BP) regulation during isometric exercise. Sixteen volunteers (8 women) performed 2 min of ischemic isometric handgrip exercise (IHE) and 2 min of postexercise circulatory occlusion (PECO). Heart rate (HR) and beat-to-beat arterial BP were continuously measured. Beat-to-beat estimates of stroke volume (ModelFlow) were obtained and matched with HR to calculate cardiac output (Q̇) and total peripheral resistance (TPR). Two trials were randomly conducted between placebo and nonselective β-adrenergic blockade (40 mg propranolol). Under the placebo condition, the magnitude of the BP response in IHE was lower in women compared with men. During PECO, the BP remained elevated and the sex differences persisted. The β-blockade attenuated the BP response during IHE in men (∆57 ± 4 vs. ∆45 ± 7 mmHg,  P  = 0.025) due to a reduction in Q̇ (∆3.7 ± 0.5 vs. ∆1.8 ± 0.2 L/min,  P  = 0.012) while TPR was not affected. In women, however, the BP response during IHE was unchanged (∆27 ± 3 vs. ∆28 ± 3 mmHg,  P  = 0.889), despite attenuated Q̇ (∆2.7 ± 0.4 vs. ∆1.3 ± 0.2 L/min,  P  = 0.012). These responses were mediated by a robust increase in TPR under β-blockade (∆-0.2 ± 0.4 vs. ∆2.2 ± 0.7 mmHg·L -1 ·min,  P  = 0.012). These findings demonstrate that the sex differences in arterial BP regulation during ischemic IHE are mediated by β-adrenergic receptors. NEW & NOTEWORTHY  We found that the blood pressure response during isometric exercise in women is mediated by increases in cardiac output, whereas in men it is mediated by increases in both cardiac output and total peripheral resistance. In addition, women showed a robust increase in total peripheral resistance under β-blockade during isometric exercise and muscle metaboreflex activation. These findings demonstrate that sex differences in blood pressure regulation during isometric exercise are mediated by β-adrenergic receptors.",2019,These responses were mediated by a robust increase in TPR under β-blockade,['Sixteen volunteers (8 women'],"['placebo and non-selective β-adrenergic blockade (40mg propranolol', 'ischemic isometric handgrip exercise (IHE) and 2 min of post exercise circulatory occlusion (PECO', 'l/min  vs  ∆', 'L-1.min']","['Blood Pressure Regulation', 'arterial blood pressure (BP) regulation', 'arterial BP regulation', 'cardiac output (Q̇) and total peripheral resistance (TPR', 'Heart rate (HR) and beat-to-beat arterial BP', 'BP response in IHE', 'BP response', 'BP response during IHE', 'TPR under β-blockade']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",16.0,0.122915,These responses were mediated by a robust increase in TPR under β-blockade,"[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Samora', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Incognito', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}, {'ForeName': 'Lauro C', 'Initials': 'LC', 'LastName': 'Vianna', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasilia, Distrito Federal, Brazil.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00270.2019']
3332,30573355,Grape pomace polyphenols improve insulin response to a standard meal in healthy individuals: A pilot study.,"BACKGROUND & AIMS


Dietary polyphenols have beneficial effects on glucose/lipid metabolism in subjects at high risk to develop type 2 diabetes; however, the underlying mechanisms are not clear. We aimed to evaluate: 1) the acute effects of the consumption of a drink rich in polyphenols from red grape pomace (RGPD) on glucose/insulin and triglyceride responses to a standard meal in healthy individuals, and, 2) the relationship between plasma levels of phenolic metabolites and metabolic parameters.
METHODS


Twelve healthy men, aged 20-40 years participated in a randomized, controlled study according to a cross-over design. After a 3-day low-polyphenol diet, all participants consumed, on two different days and separated by a one week interval, after an overnight fast, a drink rich in polyphenols (1.562 g gallic acid equivalents (GAE)) or a control drink (CD, no polyphenols), followed after 3 h by a standard meal (960 kcal, 18% protein, 30% fat, 52% CHO). Blood samples were taken at fasting, 3 h after the drink, over 5 h after the standard meal and at fasting on the next day to measure plasma concentrations of glucose, insulin, triglyceride and phenolic metabolites.
RESULTS


Glycemic and triglyceride post-meal responses were similar after both the RGPD and the control drink. In contrast, postprandial insulin incremental area (iAUC 0-5h ) was 31% lower (p < 0.05), insulin secretion index was 18% lower (p < 0.016) and insulin sensitivity (S I ) index was 36% higher (p = 0.037) after the RGPD compared to CD. Among phenolic metabolites, gallic acid correlated inversely with the insulin response (r = -0.604; p = 0.032) and positively with the S I  index (r = 0.588, p = 0.037).
CONCLUSIONS


RGPD consumption acutely reduced postprandial insulin levels and improved insulin sensitivity. This effect could be likely related to the increase in gallic acid levels. This drink, added to usual diet, could contribute to increase the daily intake of polyphenols, with potential health benefits. CLINICALTRIALS.
GOV IDENTIFIER


NCT02865278.",2019,"In contrast, postprandial insulin incremental area (iAUC 0-5h ) was 31% lower (p < 0.05), insulin secretion index was 18% lower (p < 0.016) and insulin sensitivity (S I ) index was 36% higher (p = 0.037) after the RGPD compared to CD.","['subjects at high risk to develop type 2 diabetes', 'Twelve healthy men, aged 20-40 years participated', 'healthy individuals']","['Grape pomace polyphenols', 'drink rich in polyphenols from red grape pomace (RGPD', 'drink rich in polyphenols (1.562\xa0g gallic acid equivalents (GAE)) or a control drink (CD, no polyphenols', '3-day low-polyphenol diet']","['glucose/insulin and triglyceride responses', 'plasma concentrations of glucose, insulin, triglyceride and phenolic metabolites', 'insulin sensitivity (S I ) index', 'postprandial insulin incremental area', 'postprandial insulin levels and improved insulin sensitivity', 'Glycemic and triglyceride post-meal responses', 'insulin secretion index', 'gallic acid levels', 'insulin response']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",12.0,0.0363531,"In contrast, postprandial insulin incremental area (iAUC 0-5h ) was 31% lower (p < 0.05), insulin secretion index was 18% lower (p < 0.016) and insulin sensitivity (S I ) index was 36% higher (p = 0.037) after the RGPD compared to CD.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy. Electronic address: marilena.vitale@unina.it.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Luongo', 'Affiliation': 'CNR-Institute of Biostructures and Bioimaging, Via Tommaso De Amicis, 95, 80131, Naples, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Naviglio', 'Affiliation': 'Department of Chemical Sciences, Federico II University of Naples, Via Cintia 21, 80126, Naples, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ciciola', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Corso Stati Uniti 4, 35127, Padova, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Castello', 'Affiliation': 'Department of Food & Drugs, University of Parma, Via Volturno 39, 43125 Parma, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Department of Food & Drugs, University of Parma, Via Volturno 39, 43125 Parma, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Department of Food & Drugs, University of Parma, Via Volturno 39, 43125 Parma, Italy; Department of Veterinary Science, University of Parma, Via Volturno 39, 43125 Parma, Italy; Microbiome Research Hub, University of Parma, Parco Area delle Scienze 11/A, 43124 Parma, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Capaldo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Institute of Food Science, National Research Council, Via Roma 64, 83100 Avellino, Italy.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.028']
3333,32250171,The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.,"BACKGROUND


Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations.
AIM


The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older.
METHODS


This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer.
RESULTS


We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals.
CONCLUSIONS


We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.",2020,,[],[],[],[],[],[],,0.0302903,,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Trine L', 'Initials': 'TL', 'LastName': 'Wilkens', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Clement A', 'Initials': 'CA', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Joline Wj', 'Initials': 'JW', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Edenberg', 'Affiliation': 'Indiana University School of Medicine, USA.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Eriksen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Ilse C', 'Initials': 'IC', 'LastName': 'Schrieks', 'Affiliation': 'Department of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': ""Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.""}]",European journal of preventive cardiology,['10.1177/2047487320912376']
3334,31517147,A Culturally Sensitive Web-based Intervention to Improve Living Donor Kidney Transplant Among African Americans.,"Introduction


There are pervasive racial disparities in access to living donor kidney transplantation, which for most patients with end-stage renal disease (ESRD) represents the optimal treatment. We previously developed a theory-driven, culturally sensitive intervention for African American (AA) patients with kidney disease called Living ACTS (About Choices in Transplantation and Sharing) as a DVD and booklet, and found this intervention was effective in increasing living donor transplant knowledge. However, it is unknown whether modifying this intervention for a Web-based environment is effective at increasing access to living donor transplantation.
Methods


We describe the Web-based Living ACTS study, a multicenter, randomized controlled study designed to test the effectiveness of a revised Living ACTS intervention in 4 transplant centers in the southeastern United States. The intervention consists of a Web site with 5 modules: Introduction, Benefits and Risks, The Kidney Transplant Process, Identifying a Potential Kidney Donor, and ACT Now (which encourages communication with friends and family about transplantation).
Results


This study will enroll approximately 800 patients from the 4 transplant centers. The primary outcome is the percentage of patients with at least 1 inquiry from a potential living donor among patients who receive Living ACTS as compared with those who receive a control Web site.
Conclusion


The results from this study are expected to demonstrate the effectiveness of an intervention designed to increase access to living donor transplantation among AA individuals. If successful, the Web-based intervention could be disseminated across the >250 transplant centers in the United States to improve equity in living donor kidney transplantation.",2019,"However, it is unknown whether modifying this intervention for a Web-based environment is effective at increasing access to living donor transplantation.
","['African Americans', 'African American (AA) patients with kidney disease called Living ACTS (About Choices in Transplantation and Sharing', '800 patients from the 4 transplant centers', 'patients with end-stage renal disease (ESRD', '4 transplant centers in the southeastern United States', 'Living Donor Kidney Transplant']",['revised Living ACTS intervention'],['percentage of patients with at least 1 inquiry from a potential living donor'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348050', 'cui_str': 'Living Donors'}]",800.0,0.0595642,"However, it is unknown whether modifying this intervention for a Web-based environment is effective at increasing access to living donor transplantation.
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Patzer', 'Affiliation': 'Health Services Research Center, Department of Medicine and Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Center, Department of Medicine and Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Nakeva', 'Initials': 'N', 'LastName': 'Redmond', 'Affiliation': 'CommunicateHealth, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'DuBay', 'Affiliation': 'Department of Transplant Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zayas', 'Affiliation': 'Renal and Pancreas Transplant Program, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Hartmann', 'Affiliation': 'Piedmont Transplant Institute, Piedmont Hospital, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mulloy', 'Affiliation': 'Department of Nephrology, Hypertension, and Transplant Medicine, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Perryman', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pastan', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Kimberly Jacob', 'Initials': 'KJ', 'LastName': 'Arriola', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health of Emory University, Atlanta, Georgia, USA.'}]",Kidney international reports,['10.1016/j.ekir.2019.05.771']
3335,32048274,"DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial.","BACKGROUND


Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the ""DEXamethasone twice for pain treatment after TKA"" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled.
METHODS


""DEXamethasone twice for pain treatment after TKA"" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and 48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively.
DISCUSSION


The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen.
TRIAL REGISTRATION


EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).",2020,The primary outcome is total opioid consumption (intravenous morphine milligram equivalents) 0,"['twice for pain treatment after Total Knee Arthroplasty', 'postoperative pain treatment after total knee arthroplasty', ""twice for pain treatment after TKA' (DEX-2-TKA""]","['dexamethasone', 'paracetamol, ibuprofen, and local infiltration analgesia', 'intravenous 24 mg dexamethasone, or matching intravenous placebo', 'DEXamethasone', 'DEX-2-TKA - DEXamethasone', 'glucocorticoid']","['1) visual analogue scale pain levels: a) during active 45 degrees flexion of the knee at 24 and 48 hours postoperatively, b) at rest', 'proportion of participants with one or more adverse events', 'total opioid consumption (intravenous morphine milligram equivalents) 0']","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'milligram'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",,0.433772,The primary outcome is total opioid consumption (intravenous morphine milligram equivalents) 0,"[{'ForeName': 'Kasper S', 'Initials': 'KS', 'LastName': 'Gasbjerg', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Troels H', 'Initials': 'TH', 'LastName': 'Lunn', 'Affiliation': 'Department of Anaesthesiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Anker', 'Initials': 'NA', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesia, Gildhøj Private Hospital, Brøndby, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bagger', 'Affiliation': 'Department of Orthopaedics, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindholm', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Brorson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kasper H', 'Initials': 'KH', 'LastName': 'Thybo', 'Affiliation': 'Department of Anaesthesiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Janus C', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13560']
3336,30545662,Body fat percentage assessment by ultrasound subcutaneous fat thickness measurements in middle-aged and older adults.,"BACKGROUND & AIMS


B-mode ultrasound accurately measures both muscle mass, body density and percent body fat (% BF) in younger adults, but how well it can estimate % BF in middle-aged and older adults using DXA-derived %BF as the criterion is unclear. We sought to develop % BF prediction equations for middle-aged and older adults using ultrasound subcutaneous fat thickness (SFT).
METHODS


A cross-sectional study of Japanese adults (n = 414, 50-79 years) where 276 subjects were randomly assigned to a model development group and the other 138 subjects were assigned to a cross-validation group. B-mode ultrasound measured SFT at nine sites. Dual energy X-ray absorptiometry (DXA) measured % BF, arm fat mass (FM) and leg FM. Stepwise multiple linear regression developed prediction equations from anthropometric data (body mass, height, waist and hip circumference) and ultrasound SFT sites. Bland-Altman plots assessed validity of the prediction equations to measure % BF in the cross-validation group.
RESULTS


The best prediction equation for % BF was the following: [% BF = 15.709 + (1.753*anterior trunk SFT) + (5.626*Sex) + (3.635*posterior upper arm SFT) - (4.428*anterior lower leg SFT) - (0.170*height) + (0.264*waist) + (anterior thigh SFT*2.241); r 2  = 0.809, standard error of the estimate (SEE) = 3.3 kg]. Arm FM and leg FM prediction equations had r 2  values ranging from 0.690 to 0.812 and SEEs of 0.29 and 0.75 kg. A small mean bias was noted for estimating % BF (-0.14%), but large limits of agreement were found (-8.0-7.7%) and systematic error was noted in all of the equations (r = 0.275 to 0.515, p < 0.05).
CONCLUSIONS


Despite high r 2  values and a small mean bias found between predicted and DXA % BF, wide limits of agreement were found with some systematic error present. Therefore, these prediction equations for middle-aged and older adults may not be sufficiently accurate to use in a clinical setting.",2019,Arm FM and leg FM prediction equations had r 2  values ranging from 0.690 to 0.812 and SEEs of 0.29 and 0.75 kg.,"['younger adults', '414, 50-79 years) where 276 subjects were randomly assigned to a model development group and the other 138 subjects', 'middle-aged and older adults', 'Japanese adults (n\xa0']","['ultrasound subcutaneous fat thickness measurements', 'ultrasound subcutaneous fat thickness (SFT']","['systematic error', 'Dual energy X-ray absorptiometry (DXA) measured % BF, arm fat mass (FM) and leg FM']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",138.0,0.0281212,Arm FM and leg FM prediction equations had r 2  values ranging from 0.690 to 0.812 and SEEs of 0.29 and 0.75 kg.,"[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Thiebaud', 'Affiliation': 'Department of Kinesiology, Texas Wesleyan University, Fort Worth, TX 76105, USA. Electronic address: rthiebaud@txwes.edu.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, School of Applied Sciences, The University of Mississippi, MS 38677, USA.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, Kevser Ermin Applied Physiology Laboratory, School of Applied Sciences, The University of Mississippi, MS 38677, USA.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Fujita', 'Affiliation': 'Department of Sports and Life Sciences, National Institute of Fitness and Sports in Kanoya, Kanoya, Kagoshima 891-2393, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Akamine', 'Affiliation': 'Department of Sports and Life Sciences, National Institute of Fitness and Sports in Kanoya, Kanoya, Kagoshima 891-2393, Japan.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.017']
3337,26942344,Trying to Conceive After an Early Pregnancy Loss: An Assessment on How Long Couples Should Wait.,"OBJECTIVE


To compare time to pregnancy and live birth among couples with varying intervals of pregnancy loss date to subsequent trying to conceive date.
METHODS


In this secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial, 1,083 women aged 18-40 years with one to two prior early losses and whose last pregnancy outcome was a nonectopic or nonmolar loss were included. Participants were actively followed for up to six menstrual cycles and, for women achieving pregnancy, until pregnancy outcome. We calculated intervals as start of trying to conceive date minus pregnancy loss date. Time to pregnancy was defined as start of trying to conceive until subsequent conception. Discrete Cox models, accounting for left truncation and right censoring, estimated fecundability odds ratios (ORs) adjusting for age, race, body mass index, education, and subfertility. Although intervals were assessed prior to randomization and thus reasoned to have no relation with treatment assignment, additional adjustment for treatment was evaluated given that low-dose aspirin was previously shown to be predictive of time to pregnancy.
RESULTS


Couples with a 0-3-month interval (n=765 [76.7%]) compared with a greater than 3-month (n=233 [23.4%]) interval were more likely to achieve live birth (53.2% compared with 36.1%) with a significantly shorter time to pregnancy leading to live birth (median [interquartile range] five cycles [three, eight], adjusted fecundability OR 1.71 [95% confidence interval 1.30-2.25]). Additionally adjusting for low-dose aspirin treatment did not appreciably alter estimates.
CONCLUSION


Our study supports the hypothesis that there is no physiologic evidence for delaying pregnancy attempt after an early loss.",2016,"Additionally adjusting for low-dose aspirin treatment did not appreciably alter estimates.
","['1,083 women aged 18-40 years with one to two prior early losses and whose last pregnancy outcome was a nonectopic or nonmolar loss were included']","['Aspirin', 'aspirin']","['time to pregnancy leading to live birth', 'live birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",1083.0,0.154171,"Additionally adjusting for low-dose aspirin treatment did not appreciably alter estimates.
","[{'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Schliep', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, and the Program of Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and the Division of Public Health, Department of Family and Preventive Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': ''}, {'ForeName': 'Rose G', 'Initials': 'RG', 'LastName': 'Radin', 'Affiliation': ''}, {'ForeName': 'Shvetha M', 'Initials': 'SM', 'LastName': 'Zarek', 'Affiliation': ''}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': ''}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000001159']
3338,32268344,The role of dopamine in dynamic effort-reward integration.,"When deciding to act, the neurotransmitter dopamine is implicated in a valuation of prospective effort and reward. However, its role in dynamic effort-reward integration during action, a process central to everyday behaviour, remains unclear. In a placebo-controlled, within-subject, study, we probed the impact of increasing brain dopamine levels (150 mg of levodopa) and blocking dopamine receptors (1.5 mg of haloperidol) in the context of a novel dynamic effort task in healthy human subjects. We show that modulating homoeostatic dopamine balance distinctly alters implicit and explicit effort allocation as a function of instantaneous reward. Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards. Conversely, pharmacological blockade of dopamine attenuated sensitivity to differences in reward context, reflected in reduced strategic effort discounting. These findings implicate dopamine in an integration of momentary physical experience and instantaneous reward, suggesting a key role of dopamine in acting to maximise reward on the fly.",2020,"Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards.",['healthy human subjects'],"['dopamine', 'brain dopamine levels (150\u2009mg of levodopa) and blocking dopamine receptors (1.5\u2009mg of haloperidol']",[],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034798', 'cui_str': 'Dopamine receptor'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]",[],,0.0198057,"Pharmacologically boosting dopamine enhanced motor vigour, reflected in an implicit increase in effort allocation for high rewards.","[{'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Michely', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Shivakumar', 'Initials': 'S', 'LastName': 'Viswanathan', 'Affiliation': 'Cognitive Neuroscience, Institute of Neuroscience & Medicine (INM-3), Research Centre Juelich, 52425, Juelich, Germany.'}, {'ForeName': 'Tobias U', 'Initials': 'TU', 'LastName': 'Hauser', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Delker', 'Affiliation': 'Medical Faculty, University of Cologne and Department of Neurology, University Hospital Cologne, 50937, Cologne, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Dolan', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, University College London, London, WC1N 3BG, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grefkes', 'Affiliation': 'Medical Faculty, University of Cologne and Department of Neurology, University Hospital Cologne, 50937, Cologne, Germany. christian.grefkes@uk-koeln.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0669-0']
3339,32124570,Stages of Behavior Change for Physical Activity in Airport Staff: a quasi-experimental study.,"OBJECTIVES


This work sought to determine the effect of an educational intervention based on the stages of change in promoting physical activity in employees in the Mashhad airport in Iran.
METHODS


This was a quasi-experimental study conducted with the participation of 60 volunteers (30 in the intervention group and 30 in the control group) who were in the stages of contemplating or preparing for change in physical activity. The intervention consisted in educational activities provided during home visits, telephone calls, group training sessions, and delivery of printed material. To gather the information, the study used five questions on the stage in which they were for behavioral change in physical activity, according to the Theoretical Model by Marcus et al., (1. pre-contemplation, 2. contemplation, 3. preparation, 4. action, and 5. maintenance), and the International Questionnaire on Physical Activity. Changes in the stages were evaluated during three moments: upon entering the study, at the end of the intervention (8th month), and two months after the second evaluation (10th month).
RESULTS


During the 10th month evaluation, it was noted that 26.7% of the subjects from the intervention group versus 3.3% from the control group improved their physical activity and were in the action stage (p < 0.01).
CONCLUSIONS


The educational intervention based on stages of change is effective in promoting physical activity in the participants and may be used in educational programs that seek to improve physical activity in the employees studied.",2020,"The intervention consisted in educational activities provided during home visits, telephone calls, group training sessions, and delivery of printed material.","['60 volunteers (30 in the intervention group and 30 in the control group) who were in the stages of contemplating or preparing for change in physical activity', 'employees in the Mashhad airport in Iran']",['educational intervention'],['physical activity'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0442629', 'cui_str': 'Airports'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",60.0,0.0174427,"The intervention consisted in educational activities provided during home visits, telephone calls, group training sessions, and delivery of printed material.","[{'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Mahmoudi', 'Affiliation': 'Mashhad University of Medical Sciences, Iran, MahmoudiKH1@mums.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghipoor', 'Affiliation': 'Mashhad University of Medical Sciences, Iran, taghipoura@mums.ac.ir.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tehrani', 'Affiliation': 'Mashhad University of Medical Sciences, Iran, Tehranih@mums.ac.ir.'}, {'ForeName': 'Hadi Zomorodi', 'Initials': 'HZ', 'LastName': 'Niat', 'Affiliation': 'Mashhad University of Medical Sciences, Iran, ZomorrodiNH1@mums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Vahedian-Shahroodi', 'Affiliation': 'Mashhad University of Medical Sciences, Iran, Vahedianm@mums.ac.ir.'}]",Investigacion y educacion en enfermeria,['10.17533/udea.iee.v38n1e02']
3340,32124572,Effect of an Interactive Training on Choosing Delivery Method among Primiparous Pregnant Women: An Interventional Study.,"OBJECTIVES


To evaluate the effect of interactive training conducted during pregnancy on choosing delivery method among primiparous women.
METHODS


Quasi-experimental study carried out in 2017 in two hospitals in the city of Bushehr (Iran), with the participation of 108 primiparous pregnant women in an educational program consisting of eight 2-hour sessions every two weeks in which interactive training activities were performed (group discussions, classroom sessions, and delivery of printed educational material) on themes related with physiological delivery, painless vaginal delivery methods, and complications of cesarean delivery without indication, among others. Before and after the intervention, the Knowledge and Preferred Method of Delivery Questionnaire by Moradabadi et al., was used to obtain information.
RESULTS


The results indicated that the level of knowledge in the group of mothers increased significantly between the pre-intervention and post-intervention assessment (13.2 versus 19.4, of 20 possible maximum points; p < 0.001). Additionally, significant difference was observed in the selection of the vaginal delivery method before and after the intervention (74.1% versus 98.1%; p < 0.001).
CONCLUSIONS


Implementation of interactive training increased knowledge of pregnant women on the delivery and induced a positive effect to encourage the primiparous mothers to have a vaginal delivery.",2020,"Additionally, significant difference was observed in the selection of the vaginal delivery method before and after the intervention (74.1% versus 98.1%; p < 0.001).
","['primiparous mothers', 'Quasi-experimental study carried out in 2017 in two hospitals in the city of Bushehr (Iran), with the participation of 108 primiparous pregnant women in an educational program consisting of eight 2-hour sessions every two weeks in which', 'primiparous women', 'Primiparous Pregnant Women']","['Interactive Training', 'interactive training activities were performed (group discussions, classroom sessions, and delivery of printed educational material', 'interactive training']","['selection of the vaginal delivery method', 'level of knowledge']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0186542,"Additionally, significant difference was observed in the selection of the vaginal delivery method before and after the intervention (74.1% versus 98.1%; p < 0.001).
","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Zarifsanaiey', 'Affiliation': 'Shiraz University of Medical Sciences, Iran, sanaieyn@sums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Bushehr University of Medical Sciences, Iran, bagheri54@yahoo.com.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Jahanpour', 'Affiliation': 'Bushehr University of Medical Sciences, Iran, f_jahanpour@yahoo.com.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Nematollahi', 'Affiliation': 'Shiraz University of Medical Sciences, Iran, samane.nematolahi@yahoo.com.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Azodi', 'Affiliation': 'Bushehr University of Medical Sciences, Bushehr, Iran, azodi.parviz@gmail.com.'}]",Investigacion y educacion en enfermeria,['10.17533/udea.iee.v38n1e04']
3341,32124574,Effectiveness of Milieu Therapy in reducing conflicts and containment rates among schizophrenia patients.,"OBJECTIVES


To evaluate effectiveness of Milieu Therapy in reduction of conflict and containment rates among schizophrenia patients.
METHODS


This study utilized quasi experimental non-equivalent control group pre-post design. One hundred schizophrenia patients admitted in acute psychiatric wards were non-randomly assigned to either of the experimental (n=50) or control group (n=50). The experimental group received both milieu therapy and routine hospital treatment. The Milieu Therapy intervention Included environmental modification and structuring ward activities, establishing effective interaction with patient, and teaching caregivers on managing conflict behavior of patient. The control group received only routine treatment in the hospital. Outcome measures on conflict and containment rates were evaluated for both the groups at baseline and at 2nd, 3rd and 15th day. The Patient-Staff Conflict Checklist Shift Report (PCC-SR) was used to collect information about rates of conflict and containment.
RESULTS


Compared with control group, the experimental group participants showed decrease in aggressive behavior, self-harm behavior and general rule breaking behavior at baseline and 2nd, 3rd and 15th day (F=4.61, p < 0.004, η2=0.04; F=11.92, p < 0.001, η2=0.11; F=6.94, p < 0.001, η2=0.06) over seven days interval.
CONCLUSIONS


The present study findings provided evidence for the effectiveness of integrating Milieu Therapy in psychiatric acute wards in reducing conflict behaviors among schizophrenia patients. Milieu therapy should be considered as an integral part of psychiatric care settings in these patients.",2020,"Compared with control group, the experimental group participants showed decrease in aggressive behavior, self-harm behavior and general rule breaking behavior at baseline and 2nd, 3rd and 15th day (F=4.61, p < 0.004, η2=0.04; F=11.92, p < 0.001, η2=0.11; F=6.94, p < 0.001, η2=0.06) over seven days interval.
","['One hundred schizophrenia patients admitted in acute psychiatric wards', 'schizophrenia patients']","['milieu therapy and routine hospital treatment', 'Milieu Therapy']","['conflicts and containment rates', 'conflict and containment rates', 'reduction of conflict and containment rates', 'aggressive behavior, self-harm behavior and general rule breaking behavior', 'conflict behaviors']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0026118', 'cui_str': 'Situational Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",100.0,0.0310864,"Compared with control group, the experimental group participants showed decrease in aggressive behavior, self-harm behavior and general rule breaking behavior at baseline and 2nd, 3rd and 15th day (F=4.61, p < 0.004, η2=0.04; F=11.92, p < 0.001, η2=0.11; F=6.94, p < 0.001, η2=0.06) over seven days interval.
","[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'India, sandhyabhat1973@gmail.com.'}, {'ForeName': 'Sreevani', 'Initials': 'S', 'LastName': 'Rentala', 'Affiliation': 'Dharwad Institute of Mental health and Neuroscience, India, sreevani.phd@gmail.com.'}, {'ForeName': 'Raveesh Bevinahalli', 'Initials': 'RB', 'LastName': 'Nanjegowda', 'Affiliation': 'Mysore Medical College, India, raveesh6@yahoo.com.'}, {'ForeName': 'Xavier Belsiyal', 'Initials': 'XB', 'LastName': 'Chellappan', 'Affiliation': 'AIIMS Rishikesh, India, jinbelsi@gmail.com.'}]",Investigacion y educacion en enfermeria,['10.17533/udea.iee.v38n1e06']
3342,31392958,Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.,"BACKGROUND


Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI.
OBJECTIVE


To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds.
DESIGN


Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved.
SETTING


Usual NHS care.
PARTICIPANTS


Patients undergoing elective/non-elective abdominal surgery, including caesarean section.
INTERVENTIONS


Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'.
MAIN OUTCOME MEASURES


Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers.
DATA SOURCES


Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals.
RESULTS


Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple,  n  = 133; glue,  n  = 129; no dressing,  n  = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy ( c -statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
LIMITATIONS


Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres.
CONCLUSIONS


A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks.
TRIAL REGISTRATION


Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).",2019,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","['primary surgical wounds', 'Phase A - we interviewed 102 participants', 'Patients undergoing elective/non-elective abdominal surgery, including caesarean section', 'surgical site infection after abdominal surgery', 'no dressing,  n \u2009=\u2009132', 'We interviewed 55 participants', '862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple,  n \u2009=\u2009133; glue,  n \u2009=\u2009129', 'Phase B - from 4 March 2016 to 30 November 2016']","[""Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing"", 'dressing types or no dressing to reduce SSI']","['SSI questionnaire response rate overall', 'SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT', 'SSI questionnaire', 'diagnostic accuracy', 'SSI']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332803', 'cui_str': 'Surgical Incision'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0017780', 'cui_str': 'Glues'}]","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017780', 'cui_str': 'Glues'}, {'cui': 'C0040277', 'cui_str': 'Tissue Adhesives'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0567460', 'cui_str': 'Dressing practice (regime/therapy)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",102.0,0.100827,"The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments.
","[{'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rhiannon C', 'Initials': 'RC', 'LastName': 'Macefield', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Waterhouse', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Torrance', 'Affiliation': 'Department of Surgery, Sandwell and West Birmingham NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Strong', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Siassakos', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Seligman', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Rickard', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pullyblank', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pope', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Pinkney', 'Affiliation': 'Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Owais', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': ""O'Callaghan"", 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Nadi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Murkin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tonia', 'Initials': 'T', 'LastName': 'Munder', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messenger', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Christel M', 'Initials': 'CM', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Mathers', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Morwena', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lovegrove', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Longman', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lloyd', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Korwar', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hill', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Hannah Gould', 'Initials': 'HG', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Musculoskeletal Research Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glasbey', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fryer', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jo C', 'Initials': 'JC', 'LastName': 'Dumville', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Draycott', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cotton', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Coast', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Calvert', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Byrne', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Oliver D', 'Initials': 'OD', 'LastName': 'Brown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katarzyna D', 'Initials': 'KD', 'LastName': 'Bera', 'Affiliation': 'Clinical Academic Graduate School, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bamford', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Danya', 'Initials': 'D', 'LastName': 'Bakhbakhi', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Atif', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Department of Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Armstrong', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Andronis', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Piriyankan', 'Initials': 'P', 'LastName': 'Ananthavarathan', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23390']
3343,3316238,Early mobilisation of Colles' fractures. A prospective trial.,"The results of a prospective controlled trial of early mobilisation of Colles' fractures in the elderly are presented. Early mobilisation produced less pain and a stronger grip. It did not lead to any greater loss of reduction of the fracture. However, there was no significant improvement in the final range of movement of the wrist. Immobilisation of the wrist for six weeks in plaster is extremely inconvenient for the elderly living alone and the patients greatly appreciated the reduction of this period of time to a minimum.",1987,"However, there was no significant improvement in the final range of movement of the wrist.","[""Colles' fractures""]",[],"['pain and a stronger grip', 'final range of movement of the wrist']","[{'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}]",,0.014332,"However, there was no significant improvement in the final range of movement of the wrist.","[{'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'McAuliffe', 'Affiliation': 'London Hospital, Whitechapel, England.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Hilliar', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Grange', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3344,3818718,Fat embolism and the fat embolism syndrome. A double-blind therapeutic study.,"Fifty-five adults who had sustained a tibial fracture, or a femoral fracture, or both, were subjected to a double-blind randomised study to determine the efficacy of methylprednisolone in treating the fat embolism syndrome. This drug maintained arterial oxygen levels, stabilised or reduced the serum level of free fatty acids, and decreased the risk of the fat embolism syndrome in a statistically significant proportion of patients. Gurd's criteria for the diagnosis of the fat embolism syndrome were found inadequate. Other more sensitive criteria for early diagnosis and effective management were determined. There were no deaths or serious morbidity in our series.",1987,"This drug maintained arterial oxygen levels, stabilised or reduced the serum level of free fatty acids, and decreased the risk of the fat embolism syndrome in a statistically significant proportion of patients.","['Fifty-five adults who had sustained a tibial fracture, or a femoral fracture, or both']",['methylprednisolone'],"['deaths or serious morbidity', 'risk of the fat embolism syndrome', 'serum level of free fatty acids', 'Fat embolism and the fat embolism syndrome']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1533618', 'cui_str': 'Fat Embolism Syndrome'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0013928', 'cui_str': 'Embolism, Fat'}]",55.0,0.090589,"This drug maintained arterial oxygen levels, stabilised or reduced the serum level of free fatty acids, and decreased the risk of the fat embolism syndrome in a statistically significant proportion of patients.","[{'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Lindeque', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Schoeman', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Dommisse', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Boeyens', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Vlok', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3345,30924265,"Exercise training in patients with a left ventricular assist device (Ex-VAD): rationale and design of a multicentre, prospective, assessor-blinded, randomized, controlled trial.","AIMS


Left ventricular assist device (LVAD) therapy is a promising option for patients with advanced heart failure (HF), refractory to guideline-mandated medical treatment either as a bridge to heart transplantation or as lifelong therapy. Functional capacity improves after LVAD implantation but remains reduced in patients with long-term LVAD therapy. Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
METHODS


The primary objective of Ex-VAD is to investigate whether a 12-week supervised ET can improve peak oxygen uptake (peakVO 2  ) measured by cardiopulmonary exercise testing (CPET) on an ergometer. The study is powered to demonstrate a group difference of 3 mL/min/kg in peakVO 2  at week 12, with a power of 0.9 and a standard deviation of 5 mL/min/kg. After baseline assessments to determine whether ET is safe, 66 patients at six trial sites with advanced HF and LVAD therapy will be randomized 2:1 to supervised ET or to the control arm of usual care alone. Patients randomized to ET will perform supervised aerobic endurance and resistance ET (three times/week) for 12 weeks. At baseline and during follow-up, anthropometry, CPET, echocardiography (at rest and exercise), and QoL evaluation will be performed. Blood samples will be collected to examine cardiac-specific relevant biomarkers. Overall physical activity, training sessions, and adherence will be monitored and documented throughout the study using accelerometers and patient diaries.
CONCLUSIONS


The Ex-VAD trial will assess the effects of a supervised ET programme on peakVO 2  and QoL in patients with LVAD. As LVAD therapy moves from crisis support to ambulatory functional enhancement, this trial will provide a rationale to improve functional capacity and, in perspective, cardiovascular outcomes in LVAD-supported patients with advanced HF.",2019,"Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
","['patients with advanced HF', 'patients with advanced heart failure (HF', 'patients with LVAD', '66 patients at six trial sites with advanced HF and LVAD therapy', 'patients supported with LVAD therapy', 'patients with long-term LVAD therapy', 'patients with a left ventricular assist device (Ex-VAD']","['cardiopulmonary exercise testing (CPET', 'Exercise training (ET', 'Left ventricular assist device (LVAD) therapy', 'Exercise training', 'supervised ET programme']","['functional capacity and quality of life (QoL', 'peak oxygen uptake (peakVO 2  ', 'Overall physical activity, training sessions, and adherence', 'Functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",,0.080522,"Exercise training (ET) improves functional capacity and quality of life (QoL) in HF and may provide incremental benefits in patients supported with LVAD therapy.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bobenko', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Schoenrath', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Knierim', 'Affiliation': 'Department of Cardiothoracic Surgery, Deutsches Herzzentrum Berlin (DHZB), Berlin, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Verheyen', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haykowsky', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, TX, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Herrmann-Lingen', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Duvinage', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pieske-Kraigher', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Halle', 'Affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Falk', 'Affiliation': 'DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Berlin, Germany.'}]",European journal of heart failure,['10.1002/ejhf.1431']
3346,32108254,Local osteo-enhancement of osteoporotic vertebra with a triphasic bone implant material increases strength-a biomechanical study.,"PURPOSE


The aim of this study was to assess the biomechanical properties of intact vertebra augmented using a local osteo-enhancement procedure to inject a triphasic calcium sulfate/calcium phosphate implant material.
METHODS


Twenty-one fresh frozen human cadaver vertebra (Th11-L2) were randomized into three groups: treatment, sham, and control (n = 7 each). Treatment included vertebral body access, saline lavage to displace soft tissue and marrow elements, and injection of the implant material to fill approximately 20% of the vertebral body by volume. The sham group included all treatment steps, but without injection of the implant material. The control group consisted of untreated intact osteoporotic vertebra. Load at failure and displacement at failure for each of the three groups were measured in axial compression loading.
RESULTS


The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham). Treated vertebra (1.11 mm) showed a significantly higher mean displacement at failure than sham vertebra (0.80 mm) (p < 0.05 for: treatment vs. sham). In the control group, the mean displacement at failure was 0.99 mm.
CONCLUSIONS


This biomechanical study shows that a local osteo-enhancement procedure using a triphasic implant material significantly increases the load at failure and displacement at failure in cadaveric osteoporotic vertebra.",2020,"The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham).","['Twenty-one fresh frozen human cadaver vertebra (Th11-L2', 'cadaveric osteoporotic vertebra']","['triphasic calcium sulfate/calcium phosphate implant material', 'triphasic bone implant material', 'untreated intact osteoporotic vertebra']","['mean failure load of treated vertebra', 'vertebral body access, saline lavage to displace soft tissue and marrow elements, and injection of the implant material', 'mean displacement at failure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}]","[{'cui': 'C0205185', 'cui_str': 'Triphasic (qualifier value)'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0440216', 'cui_str': 'Implant material (substance)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0440216', 'cui_str': 'Implant material (substance)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",21.0,0.0382321,"The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmoelz', 'Affiliation': 'Department of Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria. werner.schmoelz@i-med.ac.at.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Wimmer', 'Affiliation': 'Department of Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Romed', 'Initials': 'R', 'LastName': 'Hörmann', 'Affiliation': 'Division of Clinical and Functional Anatomy, Department of Anatomy, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sönke', 'Initials': 'S', 'LastName': 'Frey', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Tobias Ludger', 'Initials': 'TL', 'LastName': 'Schulte', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03382-x']
3347,3839796,Prostaglandin inhibition and the rate of recovery after arthroscopic meniscectomy. A randomised double-blind prospective study.,"In a double-blind, randomised, prospective study of 139 patients undergoing arthroscopic meniscectomy, those receiving a prostaglandin inhibitor (naproxen sodium) had significantly less pain, less synovitis and less effusion. They had significantly more rapid return of movement and of quadriceps function; their return to work and to sport also was significantly faster. It is recommended that, provided there are no contraindications, a prostaglandin inhibitor should be used after arthroscopic procedures.",1985,They had significantly more rapid return of movement and of quadriceps function; their return to work and to sport also was significantly faster.,"['139 patients undergoing arthroscopic meniscectomy, those receiving a']",['prostaglandin inhibitor (naproxen sodium'],"['pain, less synovitis and less effusion', 'rapid return of movement and of quadriceps function', 'Prostaglandin inhibition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0407879', 'cui_str': 'Arthroscopic meniscectomy (procedure)'}]","[{'cui': 'C0033529', 'cui_str': 'Prostaglandin Inhibitors'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",139.0,0.165024,They had significantly more rapid return of movement and of quadriceps function; their return to work and to sport also was significantly faster.,"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Ogilvie-Harris', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Corey', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3348,32107571,Effects of a dopamine agonist on trusting behaviors in females.,"Trust is central to bonding and cooperation. In many social interactions, individuals need to trust another person exclusively on the basis of their subjective impressions of the other's trustworthiness. Such impressions can be formed from social information from faces (e.g., facial trustworthiness and attractiveness) and guide trusting behaviors via activations of dopaminergic brain regions. However, the specific dopaminergic effects on impression-based trust are to date elusive. Here, in a double-blind, placebo-controlled, within-subject design, we administrated a D2/D3 dopamine agonist (pramipexole) to 28 healthy females who subsequently played a one-shot trust game with partners of varying facial trustworthiness. Our results show that by minimizing facial attractiveness information, we could isolate the specific effects of facial trustworthiness on trust in unknown partners. Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors. Notably, these effects of pramipexole on trusting behaviors interacted with participants' hormonal contraceptive use. In particular, after pramipexole intake, trust significantly decreased in hormonal contraceptive non-users. This study fills an important gap in the experimental literature on trust and its neural dynamics, unearthing the cognitive and neural modulations of trusting behaviors based on trustworthiness impressions of others.",2020,"Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors.","['females', '28 healthy females who subsequently played a one-shot trust game with partners of varying facial trustworthiness']","['placebo', 'dopamine agonist', 'pramipexole', 'D2/D3 dopamine agonist (pramipexole']",['hormonal contraceptive non-users'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}, {'cui': 'C0074710', 'cui_str': 'Pramipexole'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}]",28.0,0.0589719,"Despite no modulation of trustworthiness impressions, pramipexole intake significantly impacted trusting behaviors.","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bellucci', 'Affiliation': 'Department of Psychology I, University of Lübeck, 23562, Lübeck, Germany. gbellucc@gmail.com.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Münte', 'Affiliation': 'Department of Neurology, Universitätsklinikum Schleswig-Holstein, 23538, Lübeck, Germany.'}, {'ForeName': 'Soyoung Q', 'Initials': 'SQ', 'LastName': 'Park', 'Affiliation': 'Department of Psychology I, University of Lübeck, 23562, Lübeck, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05488-x']
3349,32096205,"Effects of enteral nutrition on patients with pressure lesions: a single center, pilot study.","OBJECTIVE


Protein-energetic malnutrition (PEM) affects prognosis and mortality in elderly patients as an inadequate nutritional status is a risk factor for the development and worsening of pressure sores (PS). We aimed to evaluate the incidence of PEM in outpatients with PS and to study the impact of nutritional support on the stage of PS.
PATIENTS AND METHODS


PS patients, divided in a group treated with artificial nutrition (group A) and those fed orally (group B) at home, were consecutively enrolled in the Integrated Home Care program of Ascoli Piceno between June and September 2015. At T0 the patients underwent medical history, nutritional, anthropometric/biochemical parameters assessment, and the staging of the PS. The same assessments and staging of the pressure lesions were performed three months later (T1).
RESULTS


Group A (n=25) started from a better nutritional status vs. group B (n=25) at T0, according to MNA assessment. Group A showed a significant improvement of nutritional status correlating with detailed control of nutrients intake and improvement of PS stage (T0 vs. T1, p<0.05). On the other hand, group B showed a significant difference between nutrients intake and nutritional needs that correlated with both malnutrition state increase and worsening of the PS staging (T0 vs. T1, p<0.05).
CONCLUSIONS


The present study shows that PEM has a significant prevalence in the elder, in general, and in older people with PS, in particular. A targeted nutritional intake can prevent and help the healing of PS.",2020,"Group A showed a significant improvement of nutritional status correlating with detailed control of nutrients intake and improvement of PS stage (T0 vs. T1, p<0.05).","['patients with pressure lesions', 'outpatients with PS', 'group A) and those fed orally (group B) at home, were consecutively enrolled in the Integrated Home Care program of Ascoli Piceno between June and September 2015', 'elderly patients', 'PS patients']","['Protein-energetic malnutrition (PEM', 'PEM', 'enteral nutrition', 'artificial nutrition']","['healing of PS', 'malnutrition state increase and worsening of the PS staging', 'nutrients intake and improvement of PS stage', 'nutritional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0047130', 'cui_str': 'PEMS'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",,0.0172518,"Group A showed a significant improvement of nutritional status correlating with detailed control of nutrients intake and improvement of PS stage (T0 vs. T1, p<0.05).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stracci', 'Affiliation': 'Clinical Nutrition Unit, ""Madonna del Soccorso"" General Hospital, San Benedetto del Tronto (AP), Italy. scarpidio@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Scarpellini', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rinninella', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Mignini', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Clementi', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Boni', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Valeri', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sansoni', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Abenavoli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rasetti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Santori', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202002_20214']
3350,32096209,Effects of oligomeric proanthocyanidins (OPCs) of red wine to improve skin whitening and moisturizing in healthy women - a placebo-controlled randomized double-blind parallel group comparative study.,"OBJECTIVE


This study was undertaken to evaluate the effects of red wine from grapes oligomeric procyanidins (OPCs) intake on skin color and skin moisture in Japanese healthy women. The purpose of this study was to improve skin condition, with the primary endpoint set to improve sunburn by ultraviolet (UV) and the secondary endpoint set to improve dryness.
PATIENTS AND METHODS


A randomized, placebo-controlled, double-blind, parallel-group study was conducted on 100 subjects (30 to 59 years of age). They were administered a test beverage, including 200 mg of the red wine OPCs (the test beverage group) or a placebo beverage (the control beverage group) once a day for 12 weeks. The properties of facial skin were measured at 0 (start value), 4th, 8th, and 12th week of the test period.
RESULTS


After 12 weeks of administration, the pigmentation scores and melanin index values of the OPC group were significantly reduced from the start value and were lower than the control group (p<0.05). In addition, the OPC group showed a significant increase in water content of the stratum corneum compared to the start value, while that of the control group significantly decreased.
CONCLUSIONS


The red wine OPCs showed the effects of skin whitening and moisturizing, and it is suggested that OPCs may improve the skin condition of healthy women.",2020,"After 12 weeks of administration, the pigmentation scores and melanin index values of the OPC group were significantly reduced from the start value and were lower than the control group (p<0.05).","['healthy women', '100 subjects (30 to 59 years of age', 'Japanese healthy women', 'healthy women - a']","['placebo', 'OPC', 'oligomeric proanthocyanidins (OPCs) of red wine to improve skin whitening and moisturizing', 'red wine from grapes oligomeric procyanidins (OPCs) intake', 'red wine OPCs (the test beverage group) or a placebo beverage']","['skin color and skin moisture', 'pigmentation scores and melanin index values', 'water content of the stratum corneum', 'properties of facial skin']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0072018', 'cui_str': 'proanthocyanidin'}, {'cui': 'C0349371', 'cui_str': 'Red wine (substance)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0072061', 'cui_str': '2H-1-Benzopyran-3,4,5,7-tetrol, 2-(3,4-dihydroxyphenyl)-2-((2-(3,4-dihydroxyphenyl)-3,4-dihydro-5,7-dihydroxy-2H-1-benzopyran-3-yl)oxy)-3,4-dihydro-'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",100.0,0.10281,"After 12 weeks of administration, the pigmentation scores and melanin index values of the OPC group were significantly reduced from the start value and were lower than the control group (p<0.05).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Suntory Global Innovation Center Ltd., Kyoto, Japan. Takatsugu_Tsuchiya@suntory.co.jp.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fukui', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Numano', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zeida', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202002_20215']
3351,31378980,Nutrient supplementation during the first 1000 days and growth of infants born to pregnant adolescents.,"Few studies have evaluated the impact of nutritional supplementation among pregnant adolescents. We examined the effects of the Rang Din Nutrition Study (RDNS) interventions on children born to mothers <20 years of age. The RDNS was a cluster-randomized effectiveness trial with four arms: (1) women and children both received small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control). We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents. Among adolescents, prenatal LNS reduced newborn stunting by 25% and small head size by 28% and had a marginally significant effect on newborn wasting, compared with IFA. Low birth weight and preterm birth were reduced only among adolescents with lower food security. Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control). Initiatives targeting pregnant adolescents in similar settings should consider inclusion of small-quantity LNS, particularly for adolescents living in food-insecure households.",2020,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"['adolescents living in food-insecure households', 'We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents', 'children born to mothers <20 years of age', 'infants born to pregnant adolescents', 'pregnant adolescents']","['Rang Din Nutrition Study (RDNS) interventions', 'Nutrient supplementation', 'small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control']","['Low birth weight and preterm birth', 'subsequent growth status', 'newborn wasting', 'newborn stunting']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",1552.0,0.0901711,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"[{'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}]",Annals of the New York Academy of Sciences,['10.1111/nyas.14191']
3352,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3353,3680341,The postphlebitic syndrome following shaft fractures of the leg. A significant late complication.,"Sixty patients each of whom had a fracture of the lower limb a minimum of five years (median 11 years) previously were studied by photoplethysmography, foot volumetry, popliteal venous reflux and arterial Doppler measurements. The non-fractured limb was used as a control. Postphlebitic symptoms were present in 51% and signs in 49% of fractured limbs compared with 4% and 24% respectively in the control limbs. The incidence was greater in patients who had fractured 15 years or more previously than in those who had fractured 5 to 15 years previously. Eleven limbs had clinically disabling postphlebitic symptoms including venous ulceration. The postphlebitic syndrome following lower limb fractures in young patients is more common than generally appreciated and develops after a prolonged latent interval. A prospective randomised study using prophylactic anticoagulation for lower limb shaft fractures may be justified.",1987,Postphlebitic symptoms were present in 51% and signs in 49% of fractured limbs compared with 4% and 24% respectively in the control limbs.,"['lower limb shaft fractures', 'patients who had fractured 15 years or more previously than in those who had fractured 5 to 15 years previously', 'Sixty patients each of whom had a fracture of the lower limb a minimum of five years (median 11 years) previously were studied by photoplethysmography, foot volumetry, popliteal venous reflux and arterial Doppler measurements']",['prophylactic anticoagulation'],"['Postphlebitic symptoms', 'disabling postphlebitic symptoms including venous ulceration']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0162599', 'cui_str': 'Light Reflection Rheography'}, {'cui': 'C0455773', 'cui_str': 'Foot volumetry (procedure)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal (qualifier value)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]",,0.0445963,Postphlebitic symptoms were present in 51% and signs in 49% of fractured limbs compared with 4% and 24% respectively in the control limbs.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Aitken', 'Affiliation': 'Vascular Laboratory, Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Immelman', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3354,3525572,A safe and effective low pressure tourniquet. A prospective evaluation.,"An unusually wide pneumatic tourniquet has recently become available; we provide a simple formula for its use with a low but effective inflation pressure. A prospective, randomised and controlled trial in 600 lower limb and 150 upper limb operations is reported. The wide tourniquet (12.5 cm) was as effective at low pressure as was a conventional tourniquet (9 cm) inflated to significantly higher pressures. Fewer patients suffered from painful paraesthesiae after operation using the broad, low-pressure tourniquet.",1986,The wide tourniquet (12.5 cm) was as effective at low pressure as was a conventional tourniquet (9 cm) inflated to significantly higher pressures.,['600 lower limb and 150 upper limb operations'],[],[],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",[],[],600.0,0.0198966,The wide tourniquet (12.5 cm) was as effective at low pressure as was a conventional tourniquet (9 cm) inflated to significantly higher pressures.,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muirhead', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3355,32090492,Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia.,"BACKGROUND


Benign prostatic hyperplasia (BPH) etiology remains poorly understood, but chronic low-grade inflammation plays a role. Pulsed electromagnetic field therapy (PEMF) (1-50 Hz) is effective in reducing tissue inflammation.
OBJECTIVES


We designed a pilot study to evaluate the effects of PEMF on prostate volume (PV) in BPH.
MATERIALS AND METHODS


This is a prospective interventional trial on 27 naive patients with BPH and lower urinary tract symptoms (LUTS). At baseline (V 0  ), all patients had blood tests, transrectal ultrasound, and questionnaires (IPSS, IIEF-15) and received a perineal PEMF device (Magcell ®  Microcirc, Physiomed Elektromedizin). PEMF was delivered on perineal area 5 minutes twice daily for 28 days, then (V 1  ) all baseline evaluations were repeated. Afterward, nine patients continued therapy for 3 more months (PT group) and 15 discontinued (FU group). A 4-month evaluation (V 2  ) was performed in both groups.
RESULTS


A reduction was observed both at V 1  and at V 2  in PV: PV V0  44.5 mL (38.0;61.6) vs PV V1  42.1 mL (33.7;61.5, P = .039) vs PV V2  41.7mL (32.7;62.8, P = .045). IPSS was reduced both at V 1  and at V 2  : IPSS V0  11 (5.7;23.2) vs IPSS V1  10 (6;16, P = .045) vs IPSS V2  9 (6;14, P = .015). Baseline IPSS was related to IPSS reduction both at V 1  (r s   = 0.313;P = .003) and at V 2  (r s   = 0.664;P < .001). PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL, 95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL, 95%CI -2.69;6.1)(P = .017, Relative Risk MetS   = 6). No changes were found in gonadal hormones or sexual function.
DISCUSSION


PEMF was able to reduce PV after 28 days of therapy. Symptoms improved in a short time, with high compliance and no effects on hormonal and sexual function or any side effects. Patients with moderate-severe LUTS and without MetS seem to benefit more from this treatment.
CONCLUSION


PEMF reduces PV and improves LUTS in a relative short time, in BPH patients. These benefits seem greater in those patients with moderate-severe LUTS but without MetS.",2020,"PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL,95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL,95%CI -2.69;6.1)(p=0.017,Relative Risk MetS  =6).","['Benign Prostatic Hyperplasia', '27 naïve patients with BPH and lower urinary tract symptoms (LUTS']","['perineal PEMF device (Magcell ®  Microcirc, Physiomed Elektromedizin', 'Pulsed Electro Magnetic Field therapy (PEMF) (1-50Hz', 'Pulsed Electromagnetic Field Therapy', 'PEMF']","['blood tests, trans-rectal ultrasound, questionnaires (IPSS, IIEF', 'gonadal hormones or sexual function', 'IPSS', 'Prostate Volume and Lower Urinary Tract Symptoms', 'hormonal and sexual function, high compliance and without side-effects', 'PV reduction']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3852954', 'cui_str': 'Physiome'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1112240', 'cui_str': 'Rectal ultrasound'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301819', 'cui_str': 'Gonadal Hormones'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",27.0,0.0399597,"PV reduction in patients without metabolic syndrome (ΔPV V1nMetS  -4.7 mL,95%CI -7.3;-2.0) was greater than in affected patients (ΔPV V1MetS  1.7 mL,95%CI -2.69;6.1)(p=0.017,Relative Risk MetS  =6).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Tenuta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Tarsitano', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mazzotta', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Lucchini', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Sesti', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Fattorini', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Pozza', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Olivieri', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Gianfrilli', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lenzi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.'}]",Andrology,['10.1111/andr.12775']
3356,32091923,"Letter by Sugimoto and Taniguchi Regarding Article, ""Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial"".",,2020,,['Patients With Implantable Cardioverter-Defibrillator'],"['Letter by Sugimoto and Taniguchi Regarding Article, ""Internal Versus External Electrical Cardioversion of Atrial Arrhythmia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia (disorder)'}]",[],,0.0246295,,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Cardiology, Kobe Red Cross Hospital, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Cardiology, Kobe Red Cross Hospital, Japan.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044066']
3357,32091927,"Response by Lüker et al to Letter Regarding Article, ""Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial"".",,2020,,['Patients With Implantable Cardioverter-Defibrillator'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]",[],[],,0.0224081,,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lüker', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electro-Physiology, Germany (J.L., A.S., D.S.).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuhr', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (K.K., S.S.), Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electro-Physiology, Germany (J.L., A.S., D.S.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nölker', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Omran', 'Affiliation': 'Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Clinic for Electrophysiology, Bad Oeynhausen, Germany (G.N., H.O.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Department of Electrophysiology, University Heart Center, Hamburg, Germany (S.W.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Andrié', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Schrickel', 'Affiliation': 'Department of Internal Medicine II, University Hospital Bonn, Germany (R.A., J.W.S.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'St Vinzenz Hospital, Cologne, Germany (S.W.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vollmann', 'Affiliation': 'Herz- & Gefäßzentrum Göttingen, Germany (D.V.).'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.-H.H.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.-H.H.).'}, {'ForeName': 'Christian-H', 'Initials': 'CH', 'LastName': 'Heeger', 'Affiliation': 'Department of Cardiology, University Hospital Lübeck, Germany (R.R.T., A.J., C.-H.H.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Metzner', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany (A.M.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiology, Heart Center Oldenburg, European Medical School Oldenburg-Groningen, Germany (S.M.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mischke', 'Affiliation': 'Medical Clinic I, Leopoldina Hospital, Schweinfurt, Germany (K.M.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Internal Medicine I, RWTH Aachen University Hospital, Germany (A.N.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fahrig', 'Affiliation': 'Klinikum Leverkusen, Germany (A.F.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Steinhauser', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (K.K., S.S.), Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Medical Clinic II, Coburg Hospital, Germany (J.B.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Department of Cardiology (S.B.), Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Center for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide, Australia (R.M., P.S.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Steven', 'Affiliation': 'University of Cologne, University Hospital Cologne, Department of Electro-Physiology, Germany (J.L., A.S., D.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.045319']
3358,31727194,The glycation level of milk protein strongly modulates post-prandial lysine availability in humans.,"Industrial heat treatment of milk results in protein glycation. A high protein glycation level has been suggested to compromise the post-prandial rise in plasma amino acid availability following protein ingestion. In the present study, we assessed the impact of glycation level of milk protein on post-prandial plasma amino acid responses in humans. Fifteen healthy, young men (age 26 (SEM 1) years, BMI 24 (SEM 1) kg/m2) participated in this randomised cross-over study and ingested milk protein powder with protein glycation levels of 3, 20 and 50 % blocked lysine. On each trial day, arterialised blood samples were collected at regular intervals during a 6-h post-prandial period to assess plasma amino acid concentrations using ultra-performance liquid chromatography. Plasma essential amino acid (EAA) concentrations increased following milk protein ingestion, with the 20 and 50 % glycated milk proteins showing lower overall EAA responses compared with the 3 % glycated milk protein (161 (SEM 7) and 142 (SEM 7) v. 178 (SEM 9) mmol/l × 6 h, respectively; P ≤ 0·011). The lower post-prandial plasma amino acid responses were fully attributed to an attenuated post-prandial rise in circulating plasma lysine concentrations. Plasma lysine responses (incremental AUC) following ingestion of the 20 and 50 % glycated milk proteins were 35 (SEM 4) and 92 (SEM 2) % lower compared with the 3 % glycated milk protein (21·3 (SEM 1·4) and 2·8 (SEM 0·7) v. 33·3 (SEM 1·7) mmol/l × 6 h, respectively; P < 0·001). Milk protein glycation lowers post-prandial plasma lysine availability in humans. The lower post-prandial availability of lysine following ingestion of proteins with a high glycation level may compromise the anabolic properties of a protein source.",2020,"Plasma essential amino acid concentrations increased following milk protein ingestion, with the 20% and 50% glycated milk proteins showing lower overall essential amino acid responses compared to the 3% glycated milk protein (161±7 and 142±7 vs 178±9 mmol·L-1·6 h-1, respectively; P≤0.011).","['Fifteen healthy, young men (age: 26±1 y, BMI: 24±1 kg·m-2', 'humans']",['Milk protein glycation'],"['overall essential amino acid responses', 'Plasma essential amino acid concentrations', 'glycated milk protein', 'glycated milk proteins', 'Plasma lysine responses (iAUC']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0026138', 'cui_str': 'Milk Proteins'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3666909', 'cui_str': 'Glycate'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0024337', 'cui_str': 'L-lysine'}]",15.0,0.0243405,"Plasma essential amino acid concentrations increased following milk protein ingestion, with the 20% and 50% glycated milk proteins showing lower overall essential amino acid responses compared to the 3% glycated milk protein (161±7 and 142±7 vs 178±9 mmol·L-1·6 h-1, respectively; P≤0.011).","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyakayiru', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Glenn A A', 'Initials': 'GAA', 'LastName': 'van Lieshout', 'Affiliation': 'FrieslandCampina, 3818 LEAmersfoort, the Netherlands.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Trommelen', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Janneau', 'Initials': 'J', 'LastName': 'van Kranenburg', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}, {'ForeName': 'Marjolijn C E', 'Initials': 'MCE', 'LastName': 'Bragt', 'Affiliation': 'FrieslandCampina, 3818 LEAmersfoort, the Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, 6229 ERMaastricht, the Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114519002927']
3359,3316240,Antibiotic prophylaxis with cefuroxime in arthroplasty of the knee.,A randomised prospective trial was undertaken of antibiotic prophylaxis given at various intervals before inflation of the tourniquet for arthroplasty of the knee. Cefuroxime assays of bone and subcutaneous fat from samples collected throughout the operation demonstrated that an interval of 10 minutes was necessary to obtain adequate prophylaxis. Improvement in the timing of antibiotic prophylaxis may result in a reduction in the incidence of infection.,1987,A randomised prospective trial was undertaken of antibiotic prophylaxis given at various intervals before inflation of the tourniquet for arthroplasty of the knee.,['arthroplasty of the knee'],"['cefuroxime', 'antibiotic prophylaxis', 'Cefuroxime']",['incidence of infection'],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0405641,A randomised prospective trial was undertaken of antibiotic prophylaxis given at various intervals before inflation of the tourniquet for arthroplasty of the knee.,"[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Johnson', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford, England.'}]",The Journal of bone and joint surgery. British volume,[]
3360,3257494,Transcutaneous electrical nerve stimulation after major amputation.,"We studied the effect of transcutaneous electrical nerve stimulation (TENS) on stump healing and postoperative and late phantom pain after major amputations of the lower limb. A total of 51 patients were randomised to one of three postoperative treatment regimens: sham TENS and chlorpromazine medication, sham TENS only, and active low frequency TENS. There were fewer re-amputations and more rapid stump healing among below-knee amputees who had received active TENS. Sham TENS had a considerable placebo effect on pain. There were, however, no significant differences in the analgesic requirements or reported prevalence of phantom pain between the groups during the first four weeks. The prevalence of phantom pain after active TENS was significantly lower after four months but not after more than one year.",1988,There were fewer re-amputations and more rapid stump healing among below-knee amputees who had received active TENS.,"['after major amputations of the lower limb', 'A total of 51 patients', 'after major amputation']","['Transcutaneous electrical nerve stimulation', 'Sham TENS', 'sham TENS and chlorpromazine medication, sham TENS only, and active low frequency TENS', 'active TENS', 'transcutaneous electrical nerve stimulation (TENS']","['pain', 'rapid stump healing', 'prevalence of phantom pain after active TENS', 'phantom pain', 're-amputations', 'stump healing and postoperative and late phantom pain', 'analgesic requirements']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0002690', 'cui_str': 'Amputation Stumps'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4048296', 'cui_str': 'Phantom Pain'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",51.0,0.127524,There were fewer re-amputations and more rapid stump healing among below-knee amputees who had received active TENS.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Finsen', 'Affiliation': 'Trondheim University Hospital, Department of Orthopaedic Surgery, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Persen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Løvlien', 'Affiliation': ''}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Veslegaard', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simensen', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gåsvann', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Benum', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3361,32078170,The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery.,"OBJECTIVES


Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) is an intraoperative ventilatory technique that allows avoidance of tracheal intubation (TI) or jet ventilation (JV) in selected laryngologic surgical cases. Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes. The objective of this prospective, randomized, patient-blinded, 2-arm parallel pilot trial was to investigate the safety and efficacy of THRIVE use for adult patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration.
METHODS


Twenty adult, American society of anesthesiology class 1-3 patients with body mass index (BMI) < 35 kg/m 2  were randomly assigned to either an experimental THRIVE group or active comparator conventional ventilation group (TI or supraglottic high-frequency JV [SHFJV]). Primary outcomes included intraoperative oxygenation, anesthesia awakening/extubation time, time to laryngoscopic suspension, number of intraoperative suspension adjustments, and operative time. Secondary patient outcomes including postanesthesia and functional patient recovery were investigated.
RESULTS


Compared to TI/SHFJV, THRIVE use was associated with significantly lower intraoperative oxygenation (SpO 2  93.0 ± 5.6% vs. 98.7 ± 1.6%), shorter time to suspension (1.8 ± 1.1 minutes vs. 4.3 ± 2.1 minutes), fewer suspension adjustments (0.4 ± 0.5 vs. 1.7 ± 0.9), and lower postoperative pain scores on recovery room admission (1.3 ± 1.9 vs. 3.7 ± 2.9) and discharge (0.9 ± 1.3 vs. 2.7 ± 1.8). The study was underpowered to detect other possible outcome differences.
CONCLUSION


We confirm the safe intraoperative oxygenation profile of THRIVE for selected patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration. THRIVE facilitated surgical exposure and improved early patient recovery, suggesting a potential economic benefit for outpatient laryngologic procedures. The results of this exploratory study provide a framework for designing future adequately powered THRIVE trials.
TRIAL REGISTER


ClinicalTrials.gov (NCT03091179).
LEVEL OF EVIDENCE


II Laryngoscope, 2020.",2020,"Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes.","['selected laryngologic surgical cases', 'Twenty adult, American society of anesthesiology class 1-3 patients with body mass index (BMI)\u2009<\u200935\u2009kg/m 2', 'Laryngologic Surgery', 'selected patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration', 'adult patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration']","['Transnasal Humidified Rapid-Insufflation Ventilatory Exchange', 'tracheal intubation (TI) or jet ventilation (JV', 'experimental THRIVE group or active comparator conventional ventilation group (TI or supraglottic high-frequency JV [SHFJV', 'Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE']","['postoperative pain scores', 'intraoperative oxygenation, anesthesia awakening/extubation time, time to laryngoscopic suspension, number of intraoperative suspension adjustments, and operative time', 'surgical precision, decrease operative time', 'intraoperative oxygenation', 'safety and efficacy', 'postanesthesia and functional patient recovery', 'shorter time to suspension']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",20.0,0.150251,"Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes.","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Nekhendzy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Brita', 'Initials': 'B', 'LastName': 'Mittal', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Kwang', 'Initials': 'K', 'LastName': 'Sung', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Karuna', 'Initials': 'K', 'LastName': 'Dewan', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Damrose', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}]",The Laryngoscope,['10.1002/lary.28562']
3362,3286657,Epidural buprenorphine for pain relief after spinal decompression.,We report a prospective double-blind trial of the efficacy of a single epidural dose of buprenorphine on pain after spinal decompression. Postoperative pain was assessed by a linear analogue pain chart and by the additional requirement for analgesia. The patients receiving buprenorphine were significantly more comfortable (p less than 0.005) and required less analgesia in the first 12 hours after operation (p less than 0.05) than the control group. This simple procedure is recommended as an effective and safe method of reducing pain.,1988,The patients receiving buprenorphine were significantly more comfortable (p less than 0.005) and required less analgesia in the first 12 hours after operation (p less than 0.05) than the control group.,"['pain after spinal decompression', 'pain relief after spinal decompression']","['buprenorphine', 'Epidural buprenorphine']","['Postoperative pain', 'analgesia']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0408670', 'cui_str': 'Decompression of spinal cord'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",,0.0757956,The patients receiving buprenorphine were significantly more comfortable (p less than 0.005) and required less analgesia in the first 12 hours after operation (p less than 0.05) than the control group.,"[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Wilde', 'Affiliation': 'Mansfield District General Hospital, Nottinghamshire, England.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Whitaker', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moulton', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3363,32077321,Effects of a brief interpersonal conflict cognitive reappraisal intervention on improvements in access to emotion regulation strategies and depressive symptoms in college students.,"Objective:  Research has demonstrated relative success with brief interventions that utilize social psychological theory to target the root cause of unwanted behaviours. Given the intersections among anxious attachment, depression, and emotion dysregulation, the current research utilises an interpersonal conflict cognitive reappraisal intervention to evaluate improvements in depressive symptoms. We also evaluated mediation via improvements in emotion regulation and moderation by attachment anxiety.  Design:  Undergraduates ( N  = 260) completed a baseline assessment and were randomised to one of four writing conditions: An interpersonal conflict from (a) their own perspective; (b) the other party's perspective; or (c) a neutral, third-party perspective (primary experimental condition) or about their day (control condition). They also completed a follow-up survey online two weeks later.  Main outcome measures  included limited access to emotion regulation strategies and depressive symptoms.  Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies. There was also a significant indirect effect on depressive symptoms through changes in strategies. Finally, improving strategies led to a reduction in depressive symptoms, especially for those higher in attachment anxiety.  Conclusion:  We present promising emerging results for a single-session, conflict-focused, brief cognitive reappraisal intervention on changes in emotion regulation and depressive symptoms.",2020,"Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies.","['college students', 'Undergraduates ( N \u2009=\u2009260']","['cognitive reappraisal intervention', 'interpersonal conflict cognitive reappraisal intervention', ""interpersonal conflict from (a) their own perspective; (b) the other party's perspective; or (c) a neutral, third-party perspective (primary experimental condition) or about their day (control condition""]","['anxious attachment, depression, and emotion dysregulation', 'emotion regulation strategies and depressive symptoms', 'emotion regulation and moderation by attachment anxiety', 'emotion regulation and depressive symptoms', 'depressive symptoms', 'limited access to emotion regulation strategies and depressive symptoms']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]",,0.0601253,"Results:  Consistent with hypotheses, compared to control, participants who adopted the perspective of neutral third party reported improvements in access to emotion regulation strategies.","[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Katherine D M', 'Initials': 'KDM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, University of New Hampshire, Durham, NH, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Onufrak', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Jaclyn B', 'Initials': 'JB', 'LastName': 'Dell', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'Department of Psychology, Pennsylvania State University, State College, PA, USA.'}, {'ForeName': 'Hunter P', 'Initials': 'HP', 'LastName': 'Drake', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bryan', 'Affiliation': 'VA South Central Mental Illness Research, Education and Clinical Center, Houston, TX, USA.'}]",Psychology & health,['10.1080/08870446.2019.1711090']
3364,31375459,Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial.,"OBJECTIVE


To analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction.
METHODS


Design and setting: a randomized controlled trial, with concealed allocation and blinded assessor.
PARTICIPANTS


34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m 2 , low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17).
INTERVENTIONS


The IG received one session of cryolipolysis with -10°C of temperature for 50min. The CG was not submitted to any kind of intervention. Both groups did the evaluation protocols at baseline, 30, 60 and 90 days after the intervention.
MAIN OUTCOME MEASURES


fat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2).
RESULTS


No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)).
CONCLUSIONS


The current study showed that a single application of the utilized protocol of cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of healthy women.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03160976 (https://clinicaltrials.gov/ct2/show/NCT03160976). Contribution of the Paper: the study is one of the first studies in the literature with methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.",2020,"No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05 cm (95%CI: -0.12; 0.22), 60 days: 0.05 cm (95%CI: -0.11; 0.20) and 90 days: 0.04 cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09 cm (95%CI:-0.25; 0.08), 60 days: -0.14 cm (95%CI: -0.36; 0.09) and 90 days: -0.001 cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42 cm (95%CI: -1.1; 1.9), 60 days: -0.1 cm (95%CI: -1.74; 1.54) and 90 days: -0.007 cm (-1.9; 1.9)) and AC2 (30 days: 0.183 cm (95%CI: -0.84; 1.20), 60 days: -0.13 cm (95%CI: -1.61; 1.35) and 90 days: -0.31 cm (95%CI: -1.61; 1.00)).
","['healthy women and patient satisfaction', ""healthy women and patient's satisfaction"", 'healthy women', '34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥ 3\u202fcm, Body Mass Index between 18.5 and 27\u202fkg / m², low level of physical activity, and no contraindication to cryolipolysis']","['intervention group (IG, n\u202f=\u202f17) or control group (CG, n\u202f=\u202f17', 'cryolipolysis']","['fat thickness was measured by ultrassonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2', 'lower abdomen fat thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0391363', 'cui_str': 'adenylyl cyclase type 2'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",34.0,0.269973,"No significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05 cm (95%CI: -0.12; 0.22), 60 days: 0.05 cm (95%CI: -0.11; 0.20) and 90 days: 0.04 cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09 cm (95%CI:-0.25; 0.08), 60 days: -0.14 cm (95%CI: -0.36; 0.09) and 90 days: -0.001 cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42 cm (95%CI: -1.1; 1.9), 60 days: -0.1 cm (95%CI: -1.74; 1.54) and 90 days: -0.007 cm (-1.9; 1.9)) and AC2 (30 days: 0.183 cm (95%CI: -0.84; 1.20), 60 days: -0.13 cm (95%CI: -1.61; 1.35) and 90 days: -0.31 cm (95%CI: -1.61; 1.00)).
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Falster', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jociane', 'Initials': 'J', 'LastName': 'Schardong', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Débora Piassarollo Dos', 'Initials': 'DPD', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruna Coimbra', 'Initials': 'BC', 'LastName': 'Machado', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Basic Health Sciences, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Patrícia Viana da', 'Initials': 'PVD', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Méa', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Sáude de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: roplentz@yahoo.com.br.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.005']
3365,32078058,Cost-effectiveness analysis of voice rehabilitation for patients with laryngeal cancer: a randomized controlled study.,"INTRODUCTION


Voice problems are common following radiotherapy for laryngeal cancer. Few studies exist covering the effect of voice rehabilitation, and no previous studies exist regarding the cost of said rehabilitation. This randomized controlled study aimed to analyze the cost-effectiveness of voice rehabilitation after radiotherapy for patients with laryngeal cancer.
MATERIAL AND METHODS


A total of 66 patients with laryngeal cancer with follow-up data 12 months post-radiotherapy were included. Patients were randomized into receiving either voice rehabilitation (n = 32) or no voice rehabilitation (n = 34). The patient outcome was measured as quality-adjusted life years (QALYs). The index range between 0 and 1, where 0 equals death and 1 represents perfect health. The QALYs were assessed with the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30 mapped to EuroQoL 5 Dimension values. The cost of rehabilitation and other healthcare visits was derived from hospital systems. The patients reported the total amount of sick leave days during the first 12 months following radiotherapy. The cost-effectiveness of the voice rehabilitation was compared with no rehabilitation intervention based on the incremental cost-effectiveness ratio.
RESULTS


The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome. From a healthcare perspective, the voice rehabilitation indicates a cost 60,800 € (SEK 552,725) per gained QALY.
CONCLUSION


From a societal perspective, i.e., including the costs of production loss, voice rehabilitation compared to no voice rehabilitation following radiotherapy for laryngeal cancer seems to be cost-saving. When analyzing only the healthcare costs in relation to health outcomes, voice rehabilitation indicates an incremental cost of 60,800 € per gained QALY, which is just above the threshold of the maximum willingness to pay level.",2020,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","['patients with laryngeal cancer', '66 patients with laryngeal cancer with follow-up data 12\xa0months post-radiotherapy were included']","['voice rehabilitation after radiotherapy', 'voice rehabilitation (n\u2009=\u200932) or no voice rehabilitation', 'radiotherapy', 'voice rehabilitation']","['cost-effectiveness', 'total amount of sick leave days', 'quality-adjusted life years (QALYs', 'cost of rehabilitation and other healthcare visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007107', 'cui_str': 'Cancer of Larynx'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",66.0,0.0321077,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Finizia', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Health Economics and Policy, School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. lisa.tuomi@gu.se.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05362-8']
3366,3056948,Transcutaneous reduction and external fixation of displaced fractures of the proximal humerus. A controlled clinical trial.,"A consecutive series of 31 displaced fractures of the proximal humerus were randomly selected for treatment either by closed manipulation or by transcutaneous reduction and external fixation. Follow-up assessed the quality of reduction and healing as well as the functional outcome. The external fixation method gave better reduction, safer healing and superior function.",1988,"The external fixation method gave better reduction, safer healing and superior function.",['31 displaced fractures of the proximal humerus'],"['closed manipulation or by transcutaneous reduction and external fixation', 'Transcutaneous reduction and external fixation']","['safer healing and superior function', 'quality of reduction and healing']","[{'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020164', 'cui_str': 'Humerus'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",31.0,0.0104366,"The external fixation method gave better reduction, safer healing and superior function.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Orthopaedic Surgery U, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kofoed', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3367,31373696,Response to Glucocorticosteroids Predicts Olfactory Outcome After ESS in Chronic Rhinosinusitis.,"OBJECTIVES


Olfaction is frequently impaired in chronic rhinosinusitis with nasal polyps (CRSwNP) and often improves after endoscopic sinus surgery (ESS). Data about dynamics of olfactory changes after ESS are lacking, and little information is available concerning whether preoperatively administered glucocorticosteroids predict postoperative olfaction. Therefore, the aim of this study was to examine dynamics of olfaction after ESS in relation to the effect of preoperative administration of glucocorticosteroids in CRSwNP.
METHODS


This prospective study included 52 CRSwNP patients (30 men, 22 women, mean age 54 ± 14 years) divided into a control group (n = 31) subjected to ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively. Self-ratings of olfaction and olfactory testing using the extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score) were performed. Olfaction was measured preoperatively; after termination of glucocorticosteroid treatment (only treatment group); and 2 weeks, 1 month, and 3 months postoperatively.
RESULTS


After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%. In addition, improvement in TDI score after steroids and 3 months postoperatively were significantly correlated (r = 0.66, P = 0.01). Patients whose olfaction did not improve after glucocorticosteroids did not benefit from surgery. Regarding postoperative olfactory dynamics, TDI score reached its maximum 1 month postoperatively and decreased again approximately 3 months after surgery.
CONCLUSION


Glucocorticosteroids improved olfaction in CRSwNP comparable to surgery. In addition, changes in relation to steroids predicted olfactory outcome postoperatively. Regarding the olfactory dynamics, it could be demonstrated that olfactory function increased 1 month after surgery and decreased 3 months postoperatively.
LEVEL OF EVIDENCE


2 Laryngoscope, 130:1616-1621, 2020.",2020,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","['52 CRSwNP patients (30 men, 22 women, mean age 54\u2009±\u200914\u2009years) divided into a control group (n = 31) subjected to', 'Chronic Rhinosinusitis', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively', 'Glucocorticosteroids', 'glucocorticosteroids', 'endoscopic sinus surgery (ESS']","[""extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score"", 'olfactory function', 'TDI score', 'Olfactory Outcome', 'Olfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}]",22.0,0.0370891,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","[{'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Bogdanov', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Walliczek-Dworschak', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Whitcroft', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Basile N', 'Initials': 'BN', 'LastName': 'Landis', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}]",The Laryngoscope,['10.1002/lary.28233']
3368,32073417,Safety and efficacy of intracoronary prourokinase administration in patients with high thrombus burden.,"OBJECTIVES


The study was designed to evaluate the effect of low-dose intracoronary prourokinase administration immediately after thrombus aspiration in patients with ST-segment elevation myocardial infarction (STEMI) presenting with a serious thrombus burden.
METHODS


Consecutive STEMI patients with high thrombus burden received thrombus aspiration during primary percutaneous coronary intervention (PCI) were randomly assigned to study group (intracoronary prourokinase administration) or control group (intracoronary 0.9% sodium chloride administration). The primary endpoint was complete ST-segment resolution (STR) at 90 min after primary PCI, and the secondary endpoints included angiographic myocardial perfusion indexes.
RESULTS


Patients in study group had a higher incidence of complete STR and myocardial blush grade 3 compared with those in control group (56.52% vs. 38.89%, P = 0.017 and 57.61% vs. 38.89%, P = 0.041). The peak cardiac troponin I value and corrected thrombolysis in myocardial infarction frame count were significantly lower in study group (52.16 ± 24.67 ng/mL vs. 60.91 ± 28.81 ng/mL, P = 0.029; and 19.57 ± 9.05 vs. 22.91 ± 10.22, P = 0.020). A significant improvement in left ventricular ejection fraction and major adverse cardiac events (MACEs)-free survival was observed in study group (55.22 ± 10.50% vs. 52.18 ± 9.39%, P = 0.041; 10.87% vs. 22.22%, P = 0.039) at the 6-month follow-up. The bleeding complication was similar in both groups (17.39% vs. 12.22%, P = 0.327).
CONCLUSIONS


In STEMI patients with high thrombus burden, low-dose prourokinase intracoronary administered immediately after thrombus aspiration improves myocardial perfusion, cardiac function, and MACEs-free survival with no significant increase in major bleeding.",2020,"A significant improvement in left ventricular ejection fraction and major adverse cardiac events (MACEs)-free survival was observed in study group (55.22 ± 10.50% vs. 52.18 ± 9.39%, P = 0.041; 10.87% vs. 22.22%, P = 0.039) at the 6-month follow-up.","['patients with high thrombus burden', 'Consecutive STEMI patients with high thrombus burden received thrombus aspiration during primary percutaneous coronary intervention (PCI', 'patients with ST-segment elevation myocardial infarction (STEMI) presenting with a serious thrombus burden']","['intracoronary prourokinase', 'intracoronary prourokinase administration) or control group (intracoronary 0.9% sodium chloride administration', 'low-dose intracoronary prourokinase']","['peak cardiac troponin I value and corrected thrombolysis in myocardial infarction frame count', 'complete STR and myocardial blush grade', 'angiographic myocardial perfusion indexes', 'complete ST-segment resolution (STR', 'left ventricular ejection fraction and major adverse cardiac events (MACEs)-free survival', 'myocardial perfusion, cardiac function, and MACEs-free survival', 'major bleeding', 'Safety and efficacy', 'bleeding complication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0005874', 'cui_str': 'Blushings'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0571239,"A significant improvement in left ventricular ejection fraction and major adverse cardiac events (MACEs)-free survival was observed in study group (55.22 ± 10.50% vs. 52.18 ± 9.39%, P = 0.041; 10.87% vs. 22.22%, P = 0.039) at the 6-month follow-up.","[{'ForeName': 'Xuechao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Hebei General Hospital, Shijiazhuang, Hebei, P.R. China.'}, {'ForeName': 'Huiliang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Shiru', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Xinning', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Tianlei', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hongxiao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Rongpin', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000853']
3369,31609300,Interval Exercise Lowers Circulating CD105 Extracellular Vesicles in Prediabetes.,"BACKGROUND


Extracellular vesicles (EV) are purported to mediate type 2 diabetes and CVD risk and development. Physical activity and a balanced diet reduce disease risk, but no study has tested the hypothesis that short-term interval (INT) training would reduce EV compared with continuous (CONT) exercise in adults with prediabetes.
METHODS


Eighteen obese adults (age, 63.8 ± 1.5 yr; body mass index, 31.0 ± 1.3 kg·m) were screened for prediabetes using American Diabetes Association criteria (75 g oral glucose tolerance test). Subjects were randomized to INT (n = 10, alternating 3-min intervals at 90% and 50% HRpeak, respectively) or CONT (n = 8, 70% HRpeak) training for 12 supervised sessions over 13 d for 60 min·d. Cardiorespiratory fitness (V˙ O2peak), weight (kg), as well as ad libitum dietary intake were assessed and arterial stiffness (augmentation index via applanation tonometry) was calculated using total AUC during a 75-g oral glucose tolerance test performed 24 h after the last exercise bout. Total EV, platelet EV (CD31/CD41), endothelial EV (CD105; CD31/ CD41), platelet endothelial cell adhesion molecule (PECAM) (CD31), and leukocyte EV (CD45; CD45/CD41) were analyzed via imaging flow cytometry preintervention/postintervention.
RESULTS


The INT exercise increased V˙O2peak (P = 0.04) compared with CONT training. Although training had no effect on platelet or leukocyte EV, INT decreased Annexin V- endothelial EV CD105 compared with CONT (P = 0.04). However, after accounting for dietary sugar intake, the intensity effect was lost (P = 0.18). Increased ad libitum dietary sugar intake after training was linked to elevated AV+ CD105 (r = 0.49, P = 0.06) and AV- CD45 (r = 0.59, P = 0.01). Nonetheless, increased V˙O2peak correlated with decreased AV+ CD105 (r = -0.60, P = 0.01).
CONCLUSIONS


Interval exercise training decreases endothelial-derived EV in adults with prediabetes. Although increased sugar consumption may alter EV after a short-term exercise intervention, fitness modifies EV count.",2020,"RESULTS


INT exercise increased VO2peak (P=0.04) compared to CONT training.","['Prediabetes', 'adults with prediabetes', 'Eighteen obese adults (age']","['INT', 'continuous (CONT) exercise', 'CONT', 'Interval exercise training', 'Interval Exercise']","['AV+ CD105', 'Cardiorespiratory fitness (VO2peak), weight (kg), as well as ad-libitum dietary intake', 'INT exercise increased VO2peak', 'platelet or leukocyte EVs, INT decreased Annexin V- endothelial EV CD105', 'arterial stiffness (augmentation index via applanation tonometry; AIx', 'sugar consumption', 'Total EVs, platelet EVs (CD31/CD41), endothelial EVs (CD105; CD31/ CD41), platelet endothelial cell adhesion molecule (PECAM) (CD31) and leukocyte EVs (CD45; CD45/CD41']","[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0059249', 'cui_str': 'Lipocortin-V'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0999177', 'cui_str': 'Genus Aix (organism)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",18.0,0.0166246,"RESULTS


INT exercise increased VO2peak (P=0.04) compared to CONT training.","[{'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Musante', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'LA Salvia', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Erdbrugger', 'Affiliation': 'Division of Nephrology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002185']
3370,2925731,Deep vein thrombosis after total hip replacement. A comparison between spinal and general anaesthesia.,"The effect of hypobaric spinal anaesthesia or narcotic-halothane-relaxant general anaesthesia on the incidence of postoperative deep vein thrombosis was studied in 140 elective total hip replacements in a prospective randomised manner. Deep vein thrombosis was diagnosed using impedance plethysmography and the 125I fibrinogen uptake test, combined, in selected cases, with ascending contrast venography. The overall incidence of deep vein thrombosis was 20%. Nine patients (13%) developed deep vein thrombosis in the spinal group and nineteen (27%) in the general anaesthetic group (p less than 0.05). The incidences of proximal thrombosis and of bilateral thrombi were also less with spinal anaesthesia than with general anaesthesia. It is concluded that spinal anaesthesia reduces the risks of postoperative thromboembolism in hip replacement surgery. The presence of varicose veins, being a non-smoker and having a low body mass index were associated with an increased incidence of deep vein thrombosis.",1989,The incidences of proximal thrombosis and of bilateral thrombi were also less with spinal anaesthesia than with general anaesthesia.,"['Deep vein thrombosis after total hip replacement', 'hip replacement surgery', '140 elective total hip replacements']","['spinal anaesthesia', 'hypobaric spinal anaesthesia or narcotic-halothane-relaxant general anaesthesia']","['postoperative deep vein thrombosis', 'postoperative thromboembolism', 'proximal thrombosis and of bilateral thrombi', 'overall incidence of deep vein thrombosis', 'deep vein thrombosis', 'Deep vein thrombosis']","[{'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0018549', 'cui_str': 'Halothane'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0589110', 'cui_str': 'Postoperative deep vein thrombosis (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",140.0,0.0274473,The incidences of proximal thrombosis and of bilateral thrombi were also less with spinal anaesthesia than with general anaesthesia.,"[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Davis', 'Affiliation': 'Christchurch School of Medicine, New Zealand.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Laurenson', 'Affiliation': ''}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Gillespie', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wells', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Foate', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Newman', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3371,31619393,"A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study.","OBJECTIVE


Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.
RESEARCH DESIGN AND METHODS


Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.
RESULTS


At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57),  P  = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93),  P  = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers ( P  = 0.013).
CONCLUSIONS


This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.",2020,"Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004.","['Patients with diabetes and chronic DFUs', 'Chronic Diabetic Foot Ulcers', 'chronic wounds for more than 50 years', 'healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone']","['Placebo', 'active TWO2 therapy or sham control therapy-both in addition to optimal SOC', 'Cyclical Topical Wound Oxygen Therapy', 'adjunctive cyclical pressurized TWO2 therapy', 'multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy']","['percentage of ulcers', 'heal DFUs', 'healing chronic DFUs', 'closure rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",220.0,0.595525,"Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Frykberg', 'Affiliation': 'Diabetic Foot Consultants, Midwestern University, Glendale, AZ rgfdpm@diabeticfoot.net.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Franks', 'Affiliation': 'Centre for Research and Implementation of Clinical Practice, London, U.K.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Edmonds', 'Affiliation': ""King's College Hospital, London, U.K.""}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Brantley', 'Affiliation': 'McGuire Veterans Affairs Medical Center, Richmond, VA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wild', 'Affiliation': 'Medical Center Dessau, Brandenburg Medical School Theodor Fontane, Dessau, Germany.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Garoufalis', 'Affiliation': 'Edward Hines Jr. VA Hospital, Chicago, IL.'}, {'ForeName': 'Aliza M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Salem Veterans Affairs Medical Center, Salem, VA.'}, {'ForeName': 'Janette A', 'Initials': 'JA', 'LastName': 'Thompson', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Reach', 'Affiliation': 'Hôpital Avicenne and Paris 13 University, Bobigny, France.'}, {'ForeName': 'Cyaandi R', 'Initials': 'CR', 'LastName': 'Dove', 'Affiliation': 'Advanced Foot & Ankle Center, Las Vegas, NV.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lachgar', 'Affiliation': 'Hôpital Simone Veil, Eaubonne, Paris, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Grotemeyer', 'Affiliation': 'Hôpitaux Robert Schuman - Hôpital Kirchberg, Luxembourg City, Luxembourg.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Renton', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0476']
3372,2915010,External fixation or plaster for severely displaced comminuted Colles' fractures? A prospective study of anatomical and functional results.,"We report a prospective, randomised, controlled trial of 50 severely displaced comminuted Colles' fractures treated by either external fixation or manipulation and plaster. Each patient was assessed radiographically throughout treatment, and functionally by an independent observer at three and six months. The functional result correlated with the anatomical result, which was significantly better in patients treated by external fixation. This resulted in significantly improved function especially in young patients, and also a lower complication rate. We recommend the use of external fixation for young patients with comminuted displaced Colles' fractures unless manipulation and plaster show excellent reduction.",1989,"The functional result correlated with the anatomical result, which was significantly better in patients treated by external fixation.","[""50 severely displaced comminuted Colles' fractures treated by either"", ""young patients with comminuted displaced Colles' fractures""]","['external fixation or manipulation and plaster', 'external fixation', 'External fixation or plaster']",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}]",[],50.0,0.0117229,"The functional result correlated with the anatomical result, which was significantly better in patients treated by external fixation.","[{'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Howard', 'Affiliation': 'Derbyshire Royal Infirmary, Derby, England.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Hind', 'Affiliation': ''}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Burke', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3373,32039934,Secondary Analysis of Pain Outcomes in a Large Pragmatic Randomized Trial of Buprenorphine/Naloxone Versus Methadone for Opioid Use Disorder.,"OBJECTIVE


Opioid use disorder (OUD) is associated with chronic pain. We investigated the association between medication treatments for OUD and pain in a post-hoc secondary analysis of a randomized trial of methadone versus buprenorphine/naloxone.
METHODS


1241 individuals with OUD participated in an open label, pragmatic randomized trial of methadone versus buprenorphine/naloxone in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009. In this post-hoc analysis, pain was dichotomized (present or not present) using responses from the Short Form-36. Logistic regression models were fit to test the effect of (1) having baseline pain on week 24 retention, (2) treatment assignment on improvement in pain among those reporting pain at baseline, and (3) pain improvement at week 4 on week 24 retention among those reporting pain at baseline.
RESULTS


Almost half (48.2%) of the sample reported pain at baseline. Participants with baseline pain did not significantly differ in week 24 retention compared to those without baseline pain. Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76 [1.10, 2.82], P = 0.020).
CONCLUSION AND RELEVANCE


In this large multisite randomized trial of medication treatments for OUD, nearly half of the participants reported pain at baseline, and improvement in pain early in treatment was associated with increased likelihood of retention in treatment.",2020,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","['in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009', '1241 individuals with OUD participated in an open label, pragmatic randomized trial of']","['methadone', 'Methadone', 'methadone versus buprenorphine/naloxone', 'buprenorphine/naloxone', 'Buprenorphine/Naloxone']","['pain', 'pain improvement', 'Pain Outcomes', 'baseline pain']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",1241.0,0.257531,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","[{'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, (MS, SL, ANCC, JS, AB, EVN); Department of Psychiatry, Columbia University Medical Center, New York, NY, (MS, SL, ANCC, JS, EVN); Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, (MP); Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine; Center of Excellence in Substance Abuse Treatment and Education VA Puget Sound Health Care System, WA (AJS).'}, {'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': ''}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Broffman', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000630']
3374,32065644,Efficacy of Bronchoalveolar Lavage as Adjunct Therapy in the Treatment of Neonatal Severe Pneumonia: A Prospective Case-Control Study.,"OBJECTIVE


The aim of this study was to investigate the efficacy and safety of bronchoalveolar lavage (BAL) in the treatment of neonatal severe pneumonia (NSP).
METHODS


One hundred patients with severe pneumonia were randomly divided into two groups, the BAL and control groups, with 50 patients in each group. In the BAL group, normal saline was instilled into the endotracheal tube for BAL. Before and after lavage, lung ultrasound (LUS) monitoring was performed to observe the lung pathological changes. Conventional treatment was administered in the control group. The need for and duration of invasive mechanical ventilation, the complication rate, the duration and cost of hospitalization and the mortality rate were compared between the two groups.
RESULTS


The results of this study showed that there were 35 (70%) patients who meet the indications of the invasive mechanical ventilation (IMV) at admission in the BAL group, while there were only 15 (30%) patients still requiring IMV after BAL therapy. The duration of IMV was 41.7 ± 7.5 vs. 97.7 ± 12.9 h in BAL and controls, the incidence rate of complications was 8.0% vs. 20.0% in both groups, the length of hospital stay was 9.2 ± 1.9 vs. 14.1 ± 2.1 days in both groups, and the expense of hospital cost was 12 557 ± 832 vs. 19 121 ± 929 Chinese Yuan in both groups. All patients had stable vital signs during lavage, and no significant adverse side effects were observed.
CONCLUSION


BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.",2020,BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.,"['neonatal severe pneumonia (NSP', 'Neonatal Severe Pneumonia', 'One hundred patients with severe pneumonia']","['Bronchoalveolar Lavage', 'bronchoalveolar lavage (BAL']","['length of hospital stay', 'expense of hospital cost', 'stable vital signs', 'incidence rate of complications', 'adverse side effects', 'duration of IMV', 'invasive mechanical ventilation (IMV', 'complication rate, the duration and cost of hospitalization and the mortality rate']","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",100.0,0.0200377,BAL was significantly beneficial for NSP with no significant adverse side effects; LUS is a useful tool for the timely detection of BAL effects.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, The West Division of Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing 100043, China.'}, {'ForeName': 'Hua-Li', 'Initials': 'HL', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynecology, Emergency General Hospital, Beijing 100028, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, The West Division of Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing 100043, China.'}, {'ForeName': 'Ru-Xin', 'Initials': 'RX', 'LastName': 'Qiu', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Ren', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}, {'ForeName': 'Yue-Qiao', 'Initials': 'YQ', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology and NICU, Beijing Chaoyang District Maternal and Child Healthcare Hospital, Beijing 100021, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa010']
3375,2857181,"A 10-year assessment of controlled trials of inpatient and outpatient treatment and of plaster-of-Paris jackets for tuberculosis of the spine in children on standard chemotherapy. Studies in Masan and Pusan, Korea. Ninth report of the Medical Research Council Working Party on Tuberculosis of the Spine.","Two hundred and eighty-three patients with tuberculosis of the thoracic and/or lumbar spine have been followed for 10 years from the start of treatment. All patients received PAS plus isoniazid daily for 18 months, either with streptomycin for the first three months (SPH) or no streptomycin (PH), by random allocation. There was also a second random allocation for all patients: in Masan to inpatient rest in bed (IP) for six months followed by outpatient treatment or to ambulatory outpatient treatment from the start (OP), and in Pusan to outpatient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). A favourable status was achieved on their allocated regimen by 88% of patients at 10 years. Some of the remaining patients also attained a favourable status after additional chemotherapy and/or operation, and if these are included the proportion achieving such a status increases to 96%. There were five patients whose deaths were attributed to their spinal disease. A sinus or clinically evident abscess was present on at least one occasion in the 10-year period in 42% of the patients. Residual sinuses persisted at 10 years in two patients, at death at seven years in a third and at default in the seventh year in a fourth. Thirty-five patients had paraparesis at some time during the 10-year period, including two who died with paraplegia before five years. Complete resolution occurred in 26 patients (in six after additional chemotherapy and/or surgery). At 10 years two patients had severe paraplegia and one a moderate paraparesis.(ABSTRACT TRUNCATED AT 250 WORDS)",1985,"Thirty-five patients had paraparesis at some time during the 10-year period, including two who died with paraplegia before five years.","['At 10 years two patients had severe paraplegia and one a moderate paraparesis.(ABSTRACT', 'children on standard chemotherapy', 'Two hundred and eighty-three patients with tuberculosis of the thoracic and/or lumbar spine have been followed for 10 years from the start of treatment']","['ambulatory outpatient treatment from the start (OP), and in Pusan to outpatient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J', 'streptomycin for the first three months (SPH) or no streptomycin (PH', 'plaster-of-Paris jackets', 'PAS plus isoniazid']",['Complete resolution'],"[{'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0032160', 'cui_str': 'Plaster of Paris'}, {'cui': 'C0453944', 'cui_str': 'Jacket (physical object)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",283.0,0.0199061,"Thirty-five patients had paraparesis at some time during the 10-year period, including two who died with paraplegia before five years.",[],The Journal of bone and joint surgery. British volume,[]
3376,31327652,"Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial.","BACKGROUND


No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB).
METHODS


Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster.
RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
CONCLUSIONS


4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants.",2019,"RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
",['infants'],"['CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM', 'MenC-CRM', '4CMenB and MenC-CRM (Group 1) or MenC-CRM', 'PHiD-CV', 'pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV', 'pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2\u202f+\u202f1 schedule', 'meningococcal serogroup B (4CMenB) vaccine']","['Antibody responses', 'Immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.1851,"RESULTS


Anti-pneumococcal antibody responses were in similar ranges in the two study groups.
","[{'ForeName': 'Marco Aurelio P', 'Initials': 'MAP', 'LastName': 'Safadi', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences and CDEC, São Paulo, Brazil. Electronic address: masafadi@uol.com.br.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinon-Torres', 'Affiliation': 'Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Pediatrics Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.'}, {'ForeName': 'Lily Yin', 'Initials': 'LY', 'LastName': 'Weckx', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: lily.crie@huhsp.org.br.'}, {'ForeName': 'Edson Duarte', 'Initials': 'ED', 'LastName': 'Moreira', 'Affiliation': 'CPEC - Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil. Electronic address: edson@bahia.fiocruz.br.'}, {'ForeName': 'Eduardo Jorge', 'Initials': 'EJ', 'LastName': 'da Fonseca Lima', 'Affiliation': 'CPEC - Instituto de Medicina Integral Professor Fernando Figueira, Boa Vista Recife, PE, Brazil. Electronic address: eduardojorge@imip.org.br.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Willemsen', 'Affiliation': 'Plus100 B.V. c/o Biostatistics, GSK, Amsterdam, the Netherlands. Electronic address: arnold.x.willemsen@gsk.com.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Toneatto', 'Affiliation': 'GSK, Siena, Italy. Electronic address: daniela.x.toneatto@gsk.com.'}, {'ForeName': 'Md Ahsan', 'Initials': 'MA', 'LastName': 'Habib', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: ahsan.m.habib@gsk.com.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.07.021']
3377,31301919,Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP.,"BACKGROUND


It has been reported that persons primed with acellular (DTaP) pertussis vaccines have reduced duration of pertussis protection compared with those primed with whole-cell (DTwP) vaccines. However, due to the rapid transition to acellular vaccines, studies attempting directly to compare protection among DTaP-primed vs DTwP-primed individuals are subject to confounding by age and other limitations of ecological studies. Using validated assay results and stored sera from multiple Tdap studies, we evaluated two licensed Tdap vaccines among DTaP-primed adolescents to allow comparison with results obtained in the same laboratory from earlier studies involving DTwP-primed adolescents.
METHODS


Participants 11-12 years of age who had received exactly 5 doses of DTaP vaccine prior to 7 years of age were randomly assigned in 2012 to receive one of two licensed Tdap vaccines. Serum specimens obtained pre- and post-vaccination were assayed for responses to the vaccines. Current results were then compared to results obtained in the same laboratory from prior randomized Tdap studies conducted among adolescents primed with DTwP or DTaP.
RESULTS


Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine. However, postvaccination pertussis antibody responses were as much as 71% lower in these DTaP-primed adolescents compared with responses among DTwP-primed adolescents in a prior study of the same two Tdap vaccines. In contrast, results from the present study were similar to those seen in another study of Tdap among DTaP-primed adolescents.
DISCUSSION


Taken together, these results from randomized clinical trials provide direct evidence of reduced antibody responses to both licensed Tdap vaccines among adolescents primed with DTaP vaccine, compared with adolescents primed with DTwP vaccine. Clinical trial registry number: ClinicalTrials.gov, NCT01629589.",2019,Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine.,"['adolescents primed with DTaP and comparison with results among adolescents primed with DTwP', 'adolescents primed with DTwP or DTaP.\nRESULTS', 'Participants 11-12\u202fyears of age who had received exactly 5 doses of DTaP vaccine prior to 7\u202fyears of age']","['DTaP vaccine', 'Tdap vaccines', 'DTwP vaccine']",['postvaccination pertussis antibody responses'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1277100', 'cui_str': 'DPT Vaccine'}]","[{'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",,0.0207865,Both Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine.,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Decker', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, USA. Electronic address: td551@mdd1.org.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Greenberg', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Johnson', 'Affiliation': 'Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Vitali', 'Initials': 'V', 'LastName': 'Pool', 'Affiliation': 'US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.07.015']
3378,32060130,Serum zonulin and its diagnostic performance in non-coeliac gluten sensitivity.,"OBJECTIVE


Non-coeliac gluten sensitivity (NCGS) is characterised by intestinal and extraintestinal symptoms related to the ingestion of gluten-containing foods, in the absence of coeliac disease (CD) and wheat allergy. No biomarkers are available to diagnose NCGS and the gold standard double-blind placebo-controlled gluten challenge is clinically impractical. The aim of our work was to investigate the role of serum zonulin as a diagnostic biomarker of NCGS and to develop a diagnostic algorithm.
DESIGN


In a multicentre study, we enrolled 86 patients with either self-reported or double-blind confirmed NCGS, 59 patients with diarrhoea-predominant IBS (IBS-D), 15 patients with CD and 25 asymptomatic controls (AC). Zonulin serum levels were assessed and the associated diagnostic power calculated. Clinical and symptomatic data were recorded. The effect of diet on zonulin levels was evaluated in a subgroup of patients with NCGS.
RESULTS


Compared with ACs, the NCGS, irrespective of modality of diagnosis, and patients with CD had significantly increased levels of zonulin, as did both NCGS and patients with CD compared with participants with IBS-D. Self-reported NCGS showed increased zonulin levels compared with double-blind confirmed and not-confirmed NCGS. Six-month wheat avoidance significantly reduced zonulin levels only in HLA-DQ2/8-positive participants with NCGS. The diagnostic accuracy of zonulin levels in distinguishing NCGS from IBS-D was 81%. After exclusion of CD, a diagnostic algorithm combining zonulin levels, symptoms and gender improved the accuracy to 89%.
CONCLUSION


Zonulin can be considered a diagnostic biomarker in NCGS and combined with demographic and clinical data differentiates NCGS from IBS-D with high accuracy. Wheat withdrawal was associated with a reduction in zonulin levels only in NCGS carrying HLA genotype.",2020,Six-month wheat avoidance significantly reduced zonulin levels only in HLA-DQ2/8-positive participants with NCGS.,"['86 patients with either self-reported or double-blind confirmed NCGS, 59 patients with diarrhoea-predominant IBS (IBS-D), 15 patients with CD and 25 asymptomatic controls (AC', 'subgroup of patients with NCGS']",[],"['zonulin levels', 'levels of zonulin', 'Zonulin serum levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",86.0,0.128597,Six-month wheat avoidance significantly reduced zonulin levels only in HLA-DQ2/8-positive participants with NCGS.,"[{'ForeName': 'Maria Raffaella', 'Initials': 'MR', 'LastName': 'Barbaro', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Cremon', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Antonio Maria', 'Initials': 'AM', 'LastName': 'Morselli-Labate', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Sabatino', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Lombardia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giuffrida', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Lombardia, Italy.'}, {'ForeName': 'Gino Roberto', 'Initials': 'GR', 'LastName': 'Corazza', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Lombardia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Di Stefano', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Lombardia, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Caio', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Latella', 'Affiliation': ""Department of Clinical Medicine Public Health Life Sciences and Environment, University of L'Aquila, L'Aquila, Abruzzo, Italy.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ciacci', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry Scuola Medica Salernitana, University of Salerno, Salerno, Campania, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Fuschi', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Mastroroberto', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Bellacosa', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Stanghellini', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Volta', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Barbara', 'Affiliation': 'Department of Medical and Surgical Sciences, University of Bologna, Bologna, Emilia-Romagna, Italy giovanni.barbara@unibo.it.'}]",Gut,['10.1136/gutjnl-2019-319281']
3379,31359800,Does radiopaque cement conceal periprosthetic bone loss around femoral stems?,"BACKGROUND


Periprosthetic bone remodelling may increase fracture risk and deplete bone stock around hip implants. These changes are in part caused by implant design, advocating an early evaluation of bone remodelling properties of new implants. This can be done by repeated dual-energy x-ray absorptiometry (DXA) measurements. We know that radiopaque cement falsely elevates bone mineral density (BMD) in single measurements, however, its impact on repeated measurements, i.e. BMD changes is unexplored. We have therefore investigated whether the presence of radiopaque cement affect repeated BMD measurements.
METHODS


33 patients eligible for total hip replacement were randomly assigned to either radiopaque or radiolucent cement. BMD changes up to 12 months were measured by DXA, in addition to Harris Hip Score, plain radiographs and radiostereometric analysis (RSA).
RESULTS


Periprosthetic BMD declined during the first 3-6 months in all zones in both groups. The greatest reduction (14%) was seen in the proximal Gruen zones (1 and 7). We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
CONCLUSIONS


The presence of radiopaque agents in bone cement may influence DXA measurements of bone remodelling.ClinicalTrials.gov identifier NCT00473421.",2020,"We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
",['33 patients eligible for total hip replacement'],['radiopaque or radiolucent cement'],"['Periprosthetic BMD', 'BMD changes', 'bone mineral density (BMD', 'bone loss', 'Harris Hip Score, plain radiographs and radiostereometric analysis (RSA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0443285', 'cui_str': 'Radiolucent (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}]",33.0,0.0760213,"We found a significant difference in Gruen zones 1 and 2, where the measured bone loss was higher in the radiolucent cement group.
","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Flatøy', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dahl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stephan Maximilian', 'Initials': 'SM', 'LastName': 'Röhrl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019863352']
3380,32051971,Erosive/Abrasive Enamel Wear While Using a Combination of Anti-Erosive Toothbrush/-Paste.,"PURPOSE


To investigate dental enamel wear caused by erosion and abrasion while using a combination of anti-erosive toothbrush/-paste.
MATERIALS AND METHODS


A total of 60 enamel specimens from bovine incisors were randomly assigned into five groups of 12 specimens each (G1-5, n = 12): (G1) control group (no treatment), (G2) standard medium toothbrush Paro M43 and standard toothpaste Elmex Caries Protection, (G3) standard medium toothbrush Paro M43 and anti-erosive toothpaste Elmex Protection Erosion, (G4) anti-erosive toothbrush Elmex Erosion Soft and standard toothpaste Elmex Caries Protection, (G5) anti-erosive toothbrush Elmex Erosion Soft and anti-erosive toothpaste Elmex Protection Erosion. Initially, surface baseline profiles were recorded using profilometry. In a total of 60 cycles, all specimens were exposed to hydrochloric acid (pH = 3) for 1 min, rinsed with tap water to stop the erosive attack and brushed according to the specific protocol of each group (15 brushing strokes per run). Enamel loss was determined by comparing the surface profiles before and after 60 cycles and the results were statistically analysed using analysis of variance (ANOVA).
RESULTS


The significantly highest loss of enamel was observed in the control group G1(1.4 ± 0.20 µm) (p < 0.001). G2 turned out to be the most abrasive toothbrush/-paste combination (1.12 ± 0.15 µm), G3 the least invasive (0.40 ± 0.04 µm) (p < 0.001, respectively).
CONCLUSION


All combinations of the investigated toothbrushes/-pastes reduce erosive/abrasive enamel wear. However, the highest reduction was observed for the combination of anti-erosive toothpaste and standard toothbrush (G3).",2020,"However, the highest reduction was observed for the combination of anti-erosive toothpaste and standard toothbrush (G3).",['60 enamel specimens from bovine incisors'],"['control group (no treatment), (G2) standard medium toothbrush Paro M43 and standard toothpaste Elmex Caries Protection, (G3) standard medium toothbrush Paro M43 and anti-erosive toothpaste']","['highest loss of enamel', 'Erosive/Abrasive Enamel Wear', 'Enamel loss']","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush, device (physical object)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0059034', 'cui_str': 'Elmex'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0439679', 'cui_str': 'Erosive (qualifier value)'}]",60.0,0.019936,"However, the highest reduction was observed for the combination of anti-erosive toothpaste and standard toothbrush (G3).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Körner', 'Affiliation': ''}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Inauen', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': ''}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Wegehaupt', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43352']
3381,2722950,Re-attachment of the un-united trochanter in Charnley low friction arthroplasty.,"In a prospective study, a double crossover wire with a compression spring was used to re-attach 52 un-united trochanters at revision operations on total hip arthroplasties. Bony union was achieved in 42 (81%) and was not influenced by the duration of the nonunion or the separation gap. The new method compared favourably with earlier revisions at which other methods of trochanteric re-attachment had been used.",1989,Bony union was achieved in 42 (81%) and was not influenced by the duration of the nonunion or the separation gap.,[],['compression spring was used to re-attach 52 un-united trochanters at revision operations'],['Bony union'],[],"[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}]",,0.0161898,Bony union was achieved in 42 (81%) and was not influenced by the duration of the nonunion or the separation gap.,"[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Hodgkinson', 'Affiliation': 'Centre for Hip Surgery, Wrightington, England.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shelley', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Wroblewski', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3382,2579953,Dextran/aspirin versus heparin/dihydroergotamine in preventing thrombosis after hip fractures.,"In a randomised trial we compared the effects of two different antithrombotic regimens on the incidence of venographically established deep venous thrombosis (DVT) in 83 patients undergoing surgery for fracture of the femoral neck. Group A received dextran 40 peroperatively plus 0.5 g aspirin a day beginning before operation and continuing for 10 days after. Group B received heparin calcium 5000 iu subcutaneously plus dihydroergotamine (DHE) 0.5 mg intramuscularly, given 8-hourly, beginning before operation and continuing for 10 days after. Two patients in Group A and three in Group B developed proximal DVT, while the incidence of all DVT was 33% in Group A and 29% in Group B, a difference which was not significant. Haemorrhagic complications were much more common in the dextran/aspirin group: the volume of drainage fluid, the number of patients transfused and quantity of blood transfused, and the drop in haemoglobin level were all significantly greater in Group A. We conclude that the DHE/heparin regime is preferable to dextran/aspirin because it is safer and no less effective.",1985,"Haemorrhagic complications were much more common in the dextran/aspirin group: the volume of drainage fluid, the number of patients transfused and quantity of blood transfused, and the drop in haemoglobin level were all significantly greater in Group A.","['thrombosis after hip fractures', '83 patients undergoing surgery for fracture of the femoral neck']","['Dextran/aspirin', 'dextran/aspirin', 'heparin calcium 5000 iu subcutaneously plus dihydroergotamine (DHE', 'DHE/heparin', 'dextran 40 peroperatively plus 0.5 g aspirin', 'heparin/dihydroergotamine', 'antithrombotic regimens']","['haemoglobin level', 'proximal DVT', 'volume of drainage fluid, the number of patients transfused and quantity of blood transfused', 'Haemorrhagic complications', 'incidence of all DVT']","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]","[{'cui': 'C0086140', 'cui_str': 'Dextran'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0054452', 'cui_str': 'heparin calcium'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012291', 'cui_str': 'Dihydroergotamine'}, {'cui': 'C0643690', 'cui_str': 'DHED'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0011793', 'cui_str': 'Dextran 40'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0005768'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",83.0,0.0569053,"Haemorrhagic complications were much more common in the dextran/aspirin group: the volume of drainage fluid, the number of patients transfused and quantity of blood transfused, and the drop in haemoglobin level were all significantly greater in Group A.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pini', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Spadini', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carluccio', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Giovanardi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magnani', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Ugolotti', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Uggeri', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3383,2684990,The management of acute acromioclavicular dislocation. A randomised prospective controlled trial.,"In a prospective study, 60 patients with acute acromioclavicular dislocation were randomly allocated to treatment with a broad arm sling or to reduction and fixation with a coracoclavicular screw. Of these 54 were followed for four years. Conservatively-treated patients regained movement significantly more quickly and fully, returned to work and sport earlier and had fewer unsatisfactory results than those having early operation. For severe dislocations, with acromioclavicular displacement of 2 cm or more, early surgery produced better results. Conservative management is best for most acute dislocations, but younger patients with severe displacement may benefit from early reduction and stabilisation.",1989,"Conservatively-treated patients regained movement significantly more quickly and fully, returned to work and sport earlier and had fewer unsatisfactory results than those having early operation.",['60 patients with acute acromioclavicular dislocation'],['broad arm sling or to reduction and fixation with a coracoclavicular screw'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}]","[{'cui': 'C0183347', 'cui_str': 'Arm sling (physical object)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]",[],60.0,0.0411931,"Conservatively-treated patients regained movement significantly more quickly and fully, returned to work and sport earlier and had fewer unsatisfactory results than those having early operation.","[{'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Bannister', 'Affiliation': 'Bristol Royal Infirmary, England.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Stableforth', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hutson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3384,32067633,Biannual Treatment of Preschool Children with Single Dose Azithromycin to Reduce Mortality: Impact on Azithromycin Resistance in the MORDOR Trial in Tanzania.,"The  Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance  study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1-59 months. From each community, 40 children (aged 1-59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of  Streptococcus pneumoniae  and  Escherichia coli  were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of  S. pneumoniae  and  E. coli  isolation between treatment arms were similar. The proportions of azithromycin-resistant  S. pneumoniae  isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%;  P  = 0.26), 26.8% (16.5%;  P  = 0.29), and 13.4% (17.0%;  P  = 0.57), respectively. The proportions of azithromycin-resistant  E. coli  isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%;  P  = 0.16), 21.5% (16.6%;  P  = 0.10), and 14.9% (14.7%;  P  = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively ( P  = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.",2020,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"['Thirty randomly selected communities in Kilosa district, Tanzania', '40 children (aged 1-59 months', 'Preschool Children with Single Dose']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin versus placebo']","['mean treatment coverage', 'rates of  S. pneumoniae  and  E. coli  isolation', 'Mortality', 'mortality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",30.0,0.109285,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Coles', 'Affiliation': 'Infectious Disease Clinical Research Program, Uniformed University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Mabula', 'Initials': 'M', 'LastName': 'Kasubi', 'Affiliation': 'Department of Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0086']
3385,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3386,32067628,Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger.,"The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height  Z -score (24 months:  P  = 0.11 azithromycin communities,  P  = 0.75 placebo communities), weight-for-age  Z -score (24 months:  P  = 0.83 azithromycin,  P  = 0.78 placebo), height-for-age  Z -score (24 months:  P  = 0.30 azithromycin,  P  = 0.87 placebo), or mid-upper arm circumference (24 months:  P  = 0.12 azithromycin,  P  = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.",2020,Parasitemia was not associated with weight-for-height  Z -score,"['children living in communities participating in a cluster-randomized trial of', 'Preschool Children in Niger']","['placebo', 'biannual azithromycin', 'azithromycin']","['Malaria Parasitemia and Nutritional Status', 'height-for-age  Z', 'weight-for-age  Z -score', 'Parasitemia', 'malaria parasitemia and nutritional status', 'childhood mortality', 'malaria parasitemia', 'score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0869806,Parasitemia was not associated with weight-for-height  Z -score,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Salissou', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': 'For The Mordor Study Group', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0547']
3387,32057088,Titration of sevoflurane anesthesia to optimize the time to regain airway reflexes in patients undergoing elective surgery: A randomized clinical trial comparing desflurane and sevoflurane anesthesia.,"BACKGROUND


Desflurane has adverse environmental effects, but has clinical advantages to speed emergence and return of protective airway reflexes compared with sevoflurane. We hypothesized that weaning of the inspired sevoflurane during the final 15 minutes of surgery would eliminate differences in airway reflex recovery between these agents.
METHODS


After obtaining IRB approval and informed consent, 40 patients undergoing elective surgery (≥1-hour) randomly received desflurane or sevoflurane. Patients swallowed 20 mL of water without drooling or coughing, and then received sedation and PONV pre-medication. Anesthesia was induced using propofol and fentanyl and maintained with desflurane or sevoflurane through a laryngeal mask airway maintaining a bispectral index of 45-50 and 50-60 during the final 15 minutes before surgery end. Cardiorespiratory variables and age-adjusted minimal alveolar concentration were recorded. The duration between anesthetic discontinuation and first appropriate response to command was measured; the laryngeal mask airway was removed. Two minutes after responding to command, patients were positioned semi-upright and attempted to swallow water. If successful swallowing was not achieved, the test was repeated every 4 minutes after each failure until successful swallowing was achieved.
RESULTS


Average anesthetic concentration and bispectral index was similar in patients receiving desflurane vs sevoflurane. Response times after discontinuation of anesthetics were similar. There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups.
CONCLUSION


Weaning of sevoflurane during the final 15 minutes of surgery eliminates clinical advantages of the more rapid return of airway reflexes with desflurane.",2020,"There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups.
","['Patients swallowed 20 ml of water without drooling or coughing, and then received sedation and PONV premedication', 'After obtaining IRB approval and informed consent', 'patients undergoing elective surgery', '40 patients undergoing elective surgery (≥1-hour) randomly received']","['desflurane or sevoflurane', 'propofol and fentanyl and maintained with desflurane or sevoflurane', 'desflurane', 'Desflurane', 'sevoflurane anesthesia', 'sevoflurane']","['Cardiorespiratory variables and age-adjusted minimal alveolar concentration', 'airway reflex recovery', 'recovery of swallowing ability', 'anesthetic concentration and bispectral index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]",40.0,0.0590172,"There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups.
","[{'ForeName': 'Shahbaz R', 'Initials': 'SR', 'LastName': 'Arain', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Sherman', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dugan', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pagel', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ebert', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13565']
3388,32057254,Neratinib: the emergence of a new player in the management of HER2+ breast cancer brain metastasis.,"HER2-positive (HER2+) breast cancer has become an effectively treatable disease in the era of targeted therapies, and outcomes have improved such that prognosis of this subtype is demonstrated to be superior to HER2-negative disease. Despite these advances, durable responses in HER2+ metastatic disease are challenged by the increased risk for brain metastasis. Neratinib is an irreversible pan-HER kinase inhibitor that has emerged as an effective agent when combined with capecitabine for the management of HER2+ metastatic breast cancer patients with brain metastasis. The randomized, Phase III, NALA trial compares neratinib plus capecitabine to a currently prevailing regimen of lapatinib plus capecitabine and is provided herein. Analysis of NALA portends meaningful changes on the horizon for the management of HER2+ metastatic breast cancer.",2020,"HER2-positive (HER2+) breast cancer has become an effectively treatable disease in the era of targeted therapies, and outcomes have improved such that prognosis of this subtype is demonstrated to be superior to HER2-negative disease.","['HER2+ breast cancer brain metastasis', 'HER2+ metastatic breast cancer patients with brain metastasis']","['capecitabine', 'NALA', 'lapatinib plus capecitabine']",[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],,0.0188417,"HER2-positive (HER2+) breast cancer has become an effectively treatable disease in the era of targeted therapies, and outcomes have improved such that prognosis of this subtype is demonstrated to be superior to HER2-negative disease.","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nasrazadani', 'Affiliation': 'UPMC Hillman Cancer Center, University of Pittsburgh, 5115 Centre Ave, Pittsburgh, PA\xa015232, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': ""UPMC Hillman Cancer Center, Magee Women's Hospital, Suite 4628, 300 Halket Street, Pittsburgh, PA 15213, USA.""}]","Future oncology (London, England)",['10.2217/fon-2019-0719']
3389,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3390,32057546,"Effects of interactive robot-enhanced hand rehabilitation in treatment of paediatric hand-burns: A randomized, controlled trial with 3-months follow-up.","PURPOSE


To evaluate the effectiveness of the robotic-assisted exercise with virtual gaming on total active range of motion (ROM) of the digits, hand grip strength (HGS), and hand function in children with hand burns.
METHODS


Thirty-three children with burn caused by thermal injury (flame or scald) with the involvement of the wrist and hand, total body surface area (TBSA) <30%, and age between 6-12 years, were included in this study. The patients were randomly allocated to one of the two groups; control group (n = 16; received 60-min of the traditional hand rehabilitation program, three times per week for two successive months) and experimental group (n = 17; engaged in an additional 20 min of interactive robot-enhanced hand rehabilitation besides the traditional rehabilitation). Outcomes measured were the total active ROM of the digits, HGS, and hand function at three occasions during the study: at the baseline, post-treatment, and 3 months follow-up.
RESULTS


In the experimental group, results regarding total active (ROM) of the digits, HGS, and hand function were statistically significant in comparison to the control group either after treatment (P < .05, P = .04, and P = .005) respectively or at the follow-up (P < .05, P = .023, and P = .012) respectively favoring the experimental group.
CONCLUSION


The robot-enhanced exercise with virtual gaming can increase total active ROM of the fingers' digits, improve HGS, and hand function in children with hand burns.",2020,"(P < .05, P = .023, and P = .012) respectively favoring the experimental group.
","['paediatric hand-burns', 'children with hand burns', 'Thirty-three children with burn caused by thermal injury (flame or scald) with the involvement of the wrist and hand, total body surface area (TBSA', '30%, and age between 6-12 years']","['60-min of the traditional hand rehabilitation program, three times per week for two successive months) and experimental group (n = 17; engaged in an additional 20 min of interactive robot-enhanced hand rehabilitation besides the traditional rehabilitation', 'robotic-assisted exercise with virtual gaming', 'robot-enhanced exercise with virtual gaming', 'interactive robot-enhanced hand rehabilitation']","['total active range of motion (ROM) of the digits, hand grip strength (HGS), and hand function', 'total active (ROM) of the digits, HGS, and hand function', 'total active ROM of the digits, HGS, and hand function', ""total active ROM of the fingers' digits, improve HGS, and hand function""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332685', 'cui_str': 'Thermal injury'}, {'cui': 'C0332691', 'cui_str': 'Scalding injury (morphologic abnormality)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",33.0,0.0216215,"(P < .05, P = .023, and P = .012) respectively favoring the experimental group.
","[{'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Samhan', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia. Electronic address: ahmedsamhan44@yahoo.com.'}, {'ForeName': 'Nermeen M', 'Initials': 'NM', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.01.015']
3391,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3392,31652232,Increasing Students' Activity in Physical Education: Results of the Self-determined Exercise and Learning For FITness Trial.,"PURPOSE


To examine the effects of the Self-determined Exercise and Learning For FITness (SELF-FIT) intervention on students' moderate-to-vigorous physical activity (MVPA) and motivation in physical education (PE).
METHODS


In a clustered randomized controlled trial, 667 students (mean age, 14.4 yr; SD, 0.78) from 26 schools (i.e., clusters) were randomized into either an experimental group or a waitlist control group. Students in the experimental group received the SELF-FIT intervention, a school-based intervention designed to infuse fitness and game-like elements into PE using self-determination theory principles, whereas those in the control continued their classes using usual practices. Intervention content was provided by teachers who received training from the research team. The primary outcome was percentage of time spent in MVPA during PE. Secondary outcomes included basic psychological need satisfaction, motivation toward PE, leisure-time MVPA, and mental well-being. Data were analyzed using multilevel regression analyses and prespecified interactions were tested (i.e., group-time-sex).
RESULTS


Positive intervention effects were found on MVPA during PE (B, 4.00; 95% confidence interval, 2.96-5.04; d = 0.36). Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared with boys.
CONCLUSIONS


Fitness infusion and game-like elements, used according to self-determination theory principles, can enhance students' physical activity and motivation toward PE. This low-cost intervention has the potential to be scaled up and disseminated in secondary schools.",2020,"Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared to boys.
","['667 students (mean age = 14.4 years, SD = 0.78) from 26 schools (i.e., clusters']","['wait-list control group', 'SELF-FIT intervention', 'SELF-FIT intervention, a school-based intervention designed to infuse fitness and game-like elements into PE using self-determination theory principles']","['basic psychological need satisfaction, motivation towards PE, leisure-time MVPA, and mental well-being', 'percentage of time spent in MVPA during PE', ""students' moderate-to-vigorous physical activity (MVPA) and motivation in physical education (PE""]","[{'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517480', 'cui_str': 'Zero point seven eight'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}]",,0.0469037,"Regarding the participants' competence and autonomy need satisfaction, and autonomous motivation, the intervention effects were stronger in girls, compared to boys.
","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ha', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, HONG KONG.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Institute for Positive Psychology and Education, Australian Catholic University, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, AUSTRALIA.'}, {'ForeName': 'Johan Y Y', 'Initials': 'JYY', 'LastName': 'Ng', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, HONG KONG.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002172']
3393,32054425,Platelet-rich fibrin in combination with decalcified freeze-dried bone allograft for the management of mandibular degree II furcation defect: A randomised controlled clinical trial.,"Background : Treatment of furcation involvement of molars with periodontal disease remains challenging and unpredictable. Platelet-rich fibrin (PRF) has received the attention of researchers due to its pleiotropic properties essential for periodontal wound healing. The osteoinductive property of demineralized freeze-dried bone allograft (DFDBA) has been successfully used in periodontal regeneration.  Aim : The present study aimed to explore the effectiveness of PRF alone and with DFDBA in the treatment of mandibular degree II furcation defects in subjects with chronic periodontitis.  Material and Methods : Patients treated were from the Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly. A total of 60 mandibular molars were treated with either open flap debridement (OFD) alone, [Formula: see text] combination or [Formula: see text] combination. The soft and hard tissue parameters such as vertical probing depth (VPD), vertical clinical attachment level (VCAL), gingival marginal level (GML), horizontal probing depth (HPD), vertical bone fill (VBF), horizontal bone fill (HBF) and furcation width (FW) were determined at baseline and 9 months postoperatively. A paired [Formula: see text]-test was conducted to assess the statistical significance between time period within each group for clinical and radiographic parameters. ANOVA and  post-hoc  Tukey's tests were also conducted for intergroup comparison of soft and hard tissue parameters. Statistical significance was set at [Formula: see text].  Results and Discussion : After 9 months, all treatment groups showed significant ([Formula: see text]) improvement in soft and hard tissue parameters, except GML in all the three groups and HBF and FW in the OFD group as compared to baseline. The mean VBF change was highest in the [Formula: see text] group ([Formula: see text]) mm, followed by that in the [Formula: see text] and OFD groups ([Formula: see text] and [Formula: see text][Formula: see text]mm, respectively).  Conclusions : It was shown that both [Formula: see text] and [Formula: see text] combinations were significantly advantageous for the management of mandibular degree II furcation defects. However, the [Formula: see text] combination has significantly greater benefits than [Formula: see text] combination in terms of VBF.",2019,": After 9 months, all treatment groups showed significant ( p < 0 . 0","['60 mandibular molars', ' Patients treated were from the Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly', 'furcation involvement of molars with periodontal disease', 'mandibular degree II furcation defect', 'subjects with chronic periodontitis']","['demineralized freeze-dried bone allograft (DFDBA', 'Platelet-rich fibrin in combination with decalcified freeze-dried bone allograft', 'Platelet-rich fibrin (PRF', 'open flap debridement (OFD) alone,  PRF + OFD  combination or  OFD + PRF + DFDBA  combination', 'PRF ', 'PRF alone and with DFDBA']","['mandibular degree II furcation defects', 'HBF and FW', 'vertical probing depth (VPD), vertical clinical attachment level (VCAL), gingival marginal level (GML), horizontal probing depth (HPD), vertical bone fill (VBF), horizontal bone fill (HBF) and furcation width (FW', 'mean VBF change', '1 ) improvement in soft and hard tissue parameters, except GML']","[{'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031098', 'cui_str': 'Periodontal Medicine'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.031908,": After 9 months, all treatment groups showed significant ( p < 0 . 0","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'R G Shiva', 'Initials': 'RGS', 'LastName': 'Manjunath', 'Affiliation': 'Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'Priyamwada', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'G Shiva', 'Initials': 'GS', 'LastName': 'Shankar', 'Affiliation': 'Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}]",Singapore dental journal,['10.1142/S2214607519500032']
3394,31351901,Isokinetic eccentric training is more effective than constant load eccentric training for quadriceps rehabilitation following anterior cruciate ligament reconstruction: a randomized controlled trial.,"OBJECTIVE


To compare the effects of conventional (constant load) eccentric training and isokinetic eccentric training on quadriceps muscle mass, strength and functional performance in recreational athletes following anterior cruciate ligament (ACL) reconstruction.
METHODS


Thirty recreational male athletes (25 years old) undergoing ACL reconstruction received a standard rehabilitation program. Volunteers were randomized to conventional group (CG; n = 15) or isokinetic group (IG; n = 15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively. Assessments of quadriceps muscle mass (through magnetic resonance imaging), strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire) were performed before and after the training programs. Single leg hop test performance was assessed only at post-training evaluation.
RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques. There was no between-group difference (p > 0.05) for concentric peak torque, Lysholm score, and single leg hop test.
CONCLUSION


Isokinetic eccentric training promotes greater responses than conventional eccentric training on quadriceps muscle mass and strength of recreational athletes following ACL reconstruction.",2020,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","['anterior cruciate ligament reconstruction', 'recreational athletes following anterior cruciate ligament (ACL) reconstruction', 'Thirty recreational male athletes (˜25 years old) undergoing']","['conventional (constant load) eccentric training and isokinetic eccentric training', 'Isokinetic eccentric training', 'ACL reconstruction received a standard rehabilitation program', 'constant load eccentric training', 'conventional eccentric training', 'conventional group (CG; n\u202f=\u202f15) or isokinetic group (IG; n\u202f=\u202f15) to be engaged in a 6-week (2 sessions/week) quadriceps eccentric training program at the extensor chair or at the isokinetic dynamometer, respectively']","['strength (through isokinetic dynamometry) and self-aware functionality (through questionnaire', 'quadriceps muscle mass, strength and functional performance', 'concentric peak torque, Lysholm score, and single leg hop test', 'peak torques', 'quadriceps muscle mass and strength of recreational athletes']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C3853978'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0180957,"RESULTS


IG had significantly higher improvements than CG (p < 0.05) for all muscle mass outcomes (+17-23% vs. +5-9%), as well as for isometric (+34% vs. +20%) and eccentric (+85% vs. +23%) peak torques.","[{'ForeName': 'Marlon Francys', 'Initials': 'MF', 'LastName': 'Vidmar', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil; Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil. Electronic address: marlonfrancys@msn.com.'}, {'ForeName': 'Bruno Manfredini', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre Fróes', 'Initials': 'AF', 'LastName': 'Michelin', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Mezzomo', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Lugokenski', 'Affiliation': 'Hospital Ortopédico de Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Gilnei Lopes', 'Initials': 'GL', 'LastName': 'Pimentel', 'Affiliation': 'Physical Therapy Department, Universidade de Passo Fundo (UPF), Passo Fundo, RS, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.003']
3395,32028253,Randomized Trial of Screening and Brief Intervention to Reduce Injury and Substance Abuse in an urban Level I Trauma Center.,"BACKGROUND


The TIP (Traumatic Injury Prevention) Project evaluated the impact on post-injury drug use of two brief motivational interventions compared to brief advice (BA) among injured patients who use drugs.
METHOD


Three-group, single blind, randomized controlled trial in a Level 1Trauma Center enrolled 395 admitted patients with drug positive toxicology screen or verbal report of drug use in the previous 30 days. 34% were Hispanic, 45% non-Hispanic White, 16% non-Hispanic Black. 88% smoked marijuana, 28% used cocaine and 11% prescription opioids. Brief Advice (BA) provided advice to abstain from drugs, educational materials and referral to community resources. Brief Motivational Intervention (BMI) additionally included a 30-45 minute session, with assessment feedback, based on motivational interviewing. BMI + B included a telephone booster 4-weeks post-intervention. Drug use as measured by percent days abstinent and total abstinence, derived from the Timeline Follow back was the primary outcome.
RESULTS


A significant reduction from baseline was observed at 3, 6, and 12 months in the primary outcomes of any drug use (excluding alcohol); cannabis and cocaine, the most frequently used drugs, were analyzed individually. There were no between group differences or group X time interactions. Similarly, there were no between groups differences on secondary outcomes including perceived health status, re-injury, arrest, incarceration, alcohol and drug treatment, employment, AA attendance, homelessness, physical abuse, and problems associated with alcohol and drug use.
CONCLUSIONS


The study does not support use of these enhanced motivational interventions over brief advice for trauma patients with a positive screen for drug use.",2020,"A significant reduction from baseline was observed at 3, 6, and 12 months in the primary outcomes of any drug use (excluding alcohol); cannabis and cocaine, the most frequently used drugs, were analyzed individually.","['trauma patients with a positive screen for drug use', 'injured patients who use drugs', '395 admitted patients with drug positive toxicology screen or verbal report of drug use in the previous 30 days', '34% were Hispanic, 45% non-Hispanic White, 16% non-Hispanic Black', 'urban Level I Trauma Center']","['TIP', 'Screening and Brief Intervention', 'brief advice (BA', 'cocaine', 'Brief Motivational Intervention (BMI) additionally included a 30-45\u2009minute session, with assessment feedback, based on motivational interviewing', 'Brief Advice (BA', 'motivational interventions']","['perceived health status, re-injury, arrest, incarceration, alcohol and drug treatment, employment, AA attendance, homelessness, physical abuse, and problems associated with alcohol and drug use']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]",395.0,0.0686244,"A significant reduction from baseline was observed at 3, 6, and 12 months in the primary outcomes of any drug use (excluding alcohol); cannabis and cocaine, the most frequently used drugs, were analyzed individually.","[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX, 79968, USA; Department of Psychology, University of Texas at El Paso, University of Texas at El Paso, 500 West University Avenue, El Paso, TX, 79968, USA. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Von Sternberg', 'Affiliation': 'Health Behavior Research & Training Institute, Steve Hicks School of Social Work, The University of Texas at Austin, 1925 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Velasquez', 'Affiliation': 'Health Behavior Research & Training Institute, Steve Hicks School of Social Work, The University of Texas at Austin, 1925 San Jacinto Blvd, Austin, TX, 78712, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107792']
3396,31524825,Moderate-Intensity Continuous Training or High-Intensity Interval Training with or without Resistance Training for Altering Body Composition in Postmenopausal Women.,"PURPOSE


This study aimed to compare body composition changes induced by moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs (3 d·wk, 12 wk) in overweight/obese postmenopausal women, and to determine whether fat mass reduction is related to greater fat oxidation (FatOx).
METHODS


Participants (n = 27) were randomized in three groups: MICT (40 min at 55%-60% of peak power output), HIIT (60 × 8 s at 80%-90% of peak HR, 12 s active recovery), and HIIT + RT (HIIT + 8 whole-body exercises: 1 set of 8-12 repetitions). Dual-energy x-ray absorptiometry was used to measure whole-body and abdominal/visceral fat mass (FM) and fat-free mass. FatOx was determined at rest, during a moderate-intensity exercise (40 min at 50% of peak power output), and for 20 min postexercise, before and after training.
RESULTS


Overall, energy intake and physical activity levels did not vary from the beginning to the end of the intervention. Body weight and total FM decreased in all groups over time, but significant abdominal/visceral FM losses were observed only in HIIT and HIIT + RT groups. When expressed in percentage, total FM, fat-free mass, and muscle mass were significantly modified only by HIIT + RT training. FatOx did not change at rest but increased similarly in the three groups during and after exercise. Therefore, the HIIT-induced greater FM loss was not related to higher FatOx during or after exercise.
CONCLUSIONS


MICT or HIIT ± RT could be proposed to nondieting postmenopausal women who are overweight/obese to decrease weight and whole-body FM. The HIIT programs were more effective than MICT in reducing abdominal/visceral FM. RT addition did not potentiate this effect but increased the percentage of muscle mass.",2020,"When expressed in percentage, total FM, FFM, and muscle mass were significantly modified only by HIIT + RT training.","['Postmenopausal Women', 'Participants (n=27', 'postmenopausal women with overweight/obesity']","['MICT', 'MICT or HIIT ± RT', 'moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or HIIT + resistance training (RT) programs', 'MICT or HIIT ± RT Programs', 'DXA', 'HIIT + RT (HIIT + 8 whole-body exercises']","['FatOx', 'Overall, energy intake and physical activity levels', 'abdominal/visceral FM losses', 'FM loss', 'percentage, total FM, FFM, and muscle mass', 'abdominal/visceral FM', 'percentage of muscle mass', 'Body weight and total FM']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0238033,"When expressed in percentage, total FM, FFM, and muscle mass were significantly modified only by HIIT + RT training.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Dupuit', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Rance', 'Affiliation': 'Center of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, FRANCE.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morel', 'Affiliation': 'Center of Resources, Expertise and Performance in Sports (CREPS), Bellerive-sur-Allier, FRANCE.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bouillon', 'Affiliation': 'Department of Cardiology, Vichy Hospital, Vichy, FRANCE.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Bonnet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Florie', 'Initials': 'F', 'LastName': 'Maillard', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, FRANCE.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Boisseau', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Université Clermont Auvergne, EA 3533, Clermont-Ferrand, FRANCE.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002162']
3397,20818862,Sipuleucel-T immunotherapy for castration-resistant prostate cancer.,"BACKGROUND


Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer.
METHODS


In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase.
RESULTS


In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache.
CONCLUSIONS


The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)",2010,"In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03).","['512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or', 'men with metastatic castration-resistant prostate cancer', 'castration-resistant prostate cancer']","['docetaxel', 'placebo', 'Sipuleucel-T immunotherapy']","['median survival', 'overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase', 'risk of death', 'time to disease progression', 'chills, fever, and headache', 'Immune responses', 'time to objective disease progression', 'overall survival', '36-month survival probability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1706668', 'cui_str': 'sipuleucel-T'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1706668', 'cui_str': 'sipuleucel-T'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",512.0,0.595713,"In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03).","[{'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA. philip_kantoff@dfci.harvard.edu'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': ''}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': ''}, {'ForeName': 'E Roy', 'Initials': 'ER', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': ''}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Redfern', 'Affiliation': ''}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferrari', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': ''}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Sims', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Frohlich', 'Affiliation': ''}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Schellhammer', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1001294']
3398,32054426,Effect of scaling and root planing on level of immunoglobulin E and immunoglobulin G 4  in children with gingivitis and house-dust mite allergy: A pilot randomised controlled trial.,"Background and Objective : There is a pressing need for developing innovative strategies to prevent allergic diseases among children. As house-dust mite (HDM) allergy is often seen in children with gingivitis, strategies should be derived from a conceptual framework of allergen elimination and pathogen eradication; one such strategy is dental scaling and root planing (SRP) to remove dental plaque and periodontal pathogens. The study aimed to evaluate the beneficial effects of comprehensive 6-months dental SRP to reduce the level of immunoglobulin E (IgE) and immunoglobulin G 4  (IgG 4 ) in children with gingivitis and HDM allergy. IgE and IgG 4 , whose production is controlled mainly by Th-2 cells and B cells, are proven biomarkers for atopic inflammatory responses.  Methods : The present study conducted a non-blinded randomised controlled trial with superiority design. A total of 10 subjects (age range 6-16 years) with gingivitis and positive skin-prick test to HDM from Pediatric Allergy Outpatient Clinic, Dr. Soetomo General Hospital were enrolled in the present study. Of the 10 subjects, only five received dental SRP. We further evaluated total serum IgE and IgG 4  level before and 6 months after treatment.  Results and Discussion : Subjects in the standard treatment group showed a slight decrease in the IgE level ([Formula: see text]) but no change in the IgG 4  level ([Formula: see text]), while subjects in the intervention group showed a significant decrease in IgE ([Formula: see text]) and IgG 4  levels ([Formula: see text]).  Conclusion : The study results suggest that 6-month comprehensive dental scaling combined with root planing may help to reduce IgE and IgG 4  levels in children with gingivitis and HDM allergy. Furthermore, untreated or undertreated gingivitis is often associated with worsening allergic manifestation and thus should be avoided.  Trial Registration : ISRCTN31416107, retrospectively registered on 17 April 2018.",2019,Subjects in the standard treatment group showed a slight decrease in the IgE level ( p = 0 . 0,"['children with gingivitis', '10 subjects (age range 6-16 years) with gingivitis and positive skin-prick test to HDM from Pediatric Allergy Outpatient Clinic, Dr. Soetomo General Hospital were enrolled in the present study', 'children with gingivitis and house-dust mite allergy', 'children with gingivitis and HDM allergy', 'children']","['scaling and root planing', 'Discussion ']","['IgE level', 'IgE', 'total serum IgE and IgG 4  level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0339808', 'cui_str': 'House dust mite allergy'}]","[{'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",10.0,0.0973149,Subjects in the standard treatment group showed a slight decrease in the IgE level ( p = 0 . 0,"[{'ForeName': 'Sindy Cornelia', 'Initials': 'SC', 'LastName': 'Nelwan', 'Affiliation': 'Department of Pediatric Dentistry, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Ricardo Adrian', 'Initials': 'RA', 'LastName': 'Nugraha', 'Affiliation': 'Department of Medicine, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Anang', 'Initials': 'A', 'LastName': 'Endaryanto', 'Affiliation': 'Department of Child Health, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Frisma', 'Initials': 'F', 'LastName': 'Dewi', 'Affiliation': 'Department of Pediatric Dentistry, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Prawati', 'Initials': 'P', 'LastName': 'Nuraini', 'Affiliation': 'Department of Pediatric Dentistry, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Udijanto', 'Initials': 'U', 'LastName': 'Tedjosasongko', 'Affiliation': 'Department of Pediatric Dentistry, Universitas Airlangga, Surabaya, 60135, Indonesia.'}, {'ForeName': 'Daniel Haryono', 'Initials': 'DH', 'LastName': 'Utomo', 'Affiliation': 'Department of Orthodontics, Universitas Airlangga, Surabaya, 60135, Indonesia.'}]",Singapore dental journal,['10.1142/S2214607519500020']
3399,31918942,Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial.,"OBJECTIVES


The aim of this study was to compare optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance in patients with angiographically intermediate coronary lesions (AICLs) in a single-center, prospective, 1:1 randomized trial.
BACKGROUND


FFR and OCT imaging may help both in the assessment of AICLs and in percutaneous coronary intervention optimization.
METHODS


Patients with AICLs were randomized to FFR or OCT imaging. In the FFR arm, PCI was performed if FFR was ≤0.80. In the OCT imaging arm, PCI was performed if area stenosis was ≥75% or 50% to 75% with minimal luminal area <2.5 mm 2  or plaque rupture. Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost were assessed at the end of follow-up. The pre-defined primary endpoint was the composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score <90) at 13 months.
RESULTS


A total of 350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging). The primary endpoint of major adverse cardiac events or significant angina at 13 months occurred in 14.8% of patients in the FFR arm and in 8.0% in the OCT imaging arm (p = 0.048). This result was driven by a statistically nonsignificant lower occurrence of all primary endpoint components. Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
CONCLUSIONS


In patients with AICLs, OCT guidance is associated with lower occurrence of the composite of major adverse cardiac events or significant angina. FFR guidance is associated with a higher rate of medical management and lower costs. FFR or OCT Guidance to Revascularize Intermediate Coronary Stenosis Using Angioplasty [FORZA]; NCT01824030).",2020,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","['patients with angiographically intermediate coronary lesions (AICLs', 'Patients with AICLs', '350 patients (with 446 AICLs) were enrolled (176 randomized to FFR and 174 to OCT imaging']","['FFR or OCT imaging', 'optical coherence tomographic (OCT) guidance and fractional flow reserve (FFR) guidance', 'Fractional Flow Reserve or Optical Coherence Tomography']","['major adverse cardiac events or significant angina at 13\xa0months', 'composite of major adverse cardiac events or significant angina (defined as Seattle Angina Questionnaire frequency scale score', 'total cost', 'Angina (evaluated using the Seattle Angina Questionnaire), major adverse cardiac events, and cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",176.0,0.0356894,"Up to 13 months, the rate of medically managed patients was significantly higher (p < 0.001) and total cost significantly lower (p < 0.001) with FFR in comparison with OCT imaging.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burzotta', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: francesco.burzotta@unicatt.it.'}, {'ForeName': 'Antonio Maria', 'Initials': 'AM', 'LastName': 'Leone', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Aurigemma', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Aniello', 'Initials': 'A', 'LastName': 'Zambrano', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zimbardo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Arioti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Vergallo', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni Luigi', 'Initials': 'GL', 'LastName': 'De Maria', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cerracchio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Romagnoli', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Trani', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.034']
3400,31918944,Effect of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation: 5-Year Follow-Up of the IVUS-XPL Randomized Trial.,"OBJECTIVES


The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up.
BACKGROUND


The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up.
METHODS


The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat.
RESULTS


Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
CONCLUSIONS


Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486).",2020,"By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
","['1,400 patients with long coronary lesions (implanted stent length\xa0≥28\xa0mm) to receive']","['intravascular ultrasound (IVUS', 'Intravascular Ultrasound Guidance', 'IVUS-guided (n\xa0=\xa0700) or angiography-guided (n\xa0=\xa0700) everolimus-eluting stent implantation', 'Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation', 'angiography-guided stent implantation, IVUS-guided stent implantation']","['Major adverse cardiac events', 'adverse cardiac events', 'composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat', 'lower risk for target lesion revascularization', 'rate of major adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]",1400.0,0.212133,"By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031).
","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Tae-Soo', 'Initials': 'TS', 'LastName': 'Kang', 'Affiliation': 'Dankook University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Woong-Chol', 'Initials': 'WC', 'LastName': 'Kang', 'Affiliation': 'Gil Hospital, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Hyuckmoon', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.033']
3401,31918946,Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 2-Year Clinical Outcomes From the BIONICS and NIREUS Trials.,"OBJECTIVES


This study sought to determine clinical outcomes between treatment groups over long-term follow-up.
BACKGROUND


The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.
METHODS


Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.
RESULTS


A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).
CONCLUSIONS


In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.",2020,Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = ,"['patients with acute coronary syndromes and complex lesions', 'Patient-level data from the BIONICS (N\xa0=\xa01,919) and NIREUS', '2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n\xa0=\xa01,159) or ZES (n\xa0=\xa01,062) were included', 'patients with coronary artery disease']","['Ridaforolimus Eluting Coronary Stent System ', 'ridaforolimus-eluting stent (RES', 'Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents', 'BioNIR', 'zotarolimus-eluting stent (ZES', 'percutaneous coronary intervention with RES and ZES', 'RES', 'NIREUS (BioNIR', 'RES and ZES']","['target vessel-related myocardial infarction', '2-year rate of TLF or clinically driven target lesion revascularization', 'overall rate of stent thrombosis', 'TLF', 'Rates of target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",2221.0,0.217054,Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = ,"[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel Aviv-Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Love', 'Affiliation': 'St. Boniface General Hospital, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Melek Ozgu', 'Initials': 'MO', 'LastName': 'Ozan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gidon Y', 'Initials': 'GY', 'LastName': 'Perlman', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.08.019']
3402,19864082,Radiation with or without 6 months of androgen suppression therapy in intermediate- and high-risk clinically localized prostate cancer: a postrandomization analysis by risk group.,"PURPOSE


Six months of androgen suppression therapy (AST) plus radiation (RT) prolongs survival vs. RT alone in men with unfavorable risk localized prostate cancer (PCa), but it is unknown if this benefit applies to all risk subgroups and, in particular, the intermediate-risk group.
METHODS AND MATERIALS


Among 206 men with stages T1b to T2b PCa and either a prostate-specific antigen level of >10 or a Gleason score of > or =7 or MRI evidence of T3 disease randomized to receive 70 Gy of RT with or without 6 months of AST, Cox multivariable analysis was used to assess the impact of AST on overall survival in intermediate- and high-risk localized PCa, adjusting for age, Adult Comorbidity Evaluation 27 comorbidity score, interaction between comorbidity and treatment, and known prognostic factors. Survival estimates were compared using a two-sided log-rank test.
RESULTS


After an 8.2-year median follow-up, 74 men died. Compared to treatment with AST plus RT, treatment with RT alone was associated with an increased risk of death in intermediate-risk (adjusted hazard ratio, 3.0 [95% confidence interval, 1.3-7.2]; p = 0.01) and high-risk PCa (adjusted hazard ratio, 3.3 [95% confidence interval, 0.94-11.3]; p = 0.06). The survival benefit of adding AST was restricted to men with no or mild comorbidity in both the intermediate-risk (90.9% vs. 85.8% survival, respectively, at 7 years for AST plus RT vs. RT alone; p = 0.009) and high-risk (88.9% vs. 51.2% survival, respectively, at 7 years for AST plus RT vs. RT alone; p = 0.007) subgroups.
CONCLUSIONS


In men with localized PCa who have no or mild comorbidity, adding 6 months of AST to RT was associated with improved survival for those with both intermediate-risk and high-risk disease, but in men with moderate to severe comorbidity, no benefit was observed in either risk group.",2010,"Compared to treatment with AST plus RT, treatment with RT alone was associated with an increased risk of death in intermediate-risk (adjusted hazard ratio, 3.0 [95% confidence interval, 1.3-7.2]; p = 0.01) and high-risk PCa (adjusted hazard ratio, 3.3 [95% confidence interval, 0.94-11.3]; p = 0.06).","['intermediate- and high-risk clinically localized prostate cancer', '206 men with stages T1b to T2b PCa and either a prostate-specific antigen level of >10 or a Gleason score of > or =7 or MRI evidence of T3 disease randomized to', 'men with unfavorable risk localized prostate cancer (PCa']","['receive 70 Gy of RT with or without 6 months of AST', 'AST plus RT', 'androgen suppression therapy (AST) plus radiation (RT', 'androgen suppression therapy', 'RT alone']","['high-risk PCa', 'Survival estimates', 'survival benefit of adding AST', 'risk of death in intermediate-risk', 'survival', 'high-risk']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",206.0,0.0728649,"Compared to treatment with AST plus RT, treatment with RT alone was associated with an increased risk of death in intermediate-risk (adjusted hazard ratio, 3.0 [95% confidence interval, 1.3-7.2]; p = 0.01) and high-risk PCa (adjusted hazard ratio, 3.3 [95% confidence interval, 0.94-11.3]; p = 0.06).","[{'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': ""Department of Radiation Oncology, Dana Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts 02115, USA. pnguyen@LROC.harvard.edu""}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Clair J', 'Initials': 'CJ', 'LastName': 'Beard', 'Affiliation': ''}, {'ForeName': 'W Warren', 'Initials': 'WW', 'LastName': 'Suh', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Renshaw', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Loffredo', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McMahon', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': ""D'Amico"", 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2009.06.038']
3403,18487572,Pain predicts overall survival in men with metastatic castration-refractory prostate cancer.,"PURPOSE


Pain from castration-refractory prostate cancer (CRPC) bone metastases is a common event. Although it is assumed that pain represents an adverse prognostic factor, this variable has not been extensively evaluated. The objective of this study was to determine whether men with CRPC who had higher pain interference scores at baseline had worse clinical outcomes compared with men who had lower pain scores.
PATIENTS AND METHODS


Data from three randomized phase III multicenter trials conducted by the Cancer and Leukemia Group B from 1992 to 1998 were combined. Eligible patients had progressive CRPC adenocarcinoma of the prostate, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate hematologic, renal, and hepatic functions. Seven items from the Brief Pain Inventory were used to assess the impact of pain on a range of daily activities and quality of life, each rated on a scale from 0 to 10.
RESULTS


In 599 men, the median pain interference scores was 17 (interquartile range, 4 to 34), and 38% of the men had opioid analgesic use at baseline. There was a statistically significant association between pain interference scores and risk of death. The median survival times were 17.6 months (95% CI, 16.1 to 19.1 months) and 10.2 months (95% CI, 8.6 to 11.3 months; P < .001) in men with low (< 17) and high (>or= 17) pain scores, respectively. Pain was inversely associated with likelihood of prostate-specific antigen decline, objective response, and time to bone progression.
CONCLUSION


This analysis demonstrates that pain is a statistically significant predictor of overall survival in men with metastatic CRPC. These results need to be validated prospectively in future phase III trials.",2008,"The median survival times were 17.6 months (95% CI, 16.1 to 19.1 months) and 10.2 months (95% CI, 8.6 to 11.3 months; P < .001) in men with low (< 17) and high (>or= 17) pain scores, respectively.","['men with metastatic CRPC', 'men with CRPC who had higher', 'men with metastatic castration-refractory prostate cancer', 'Eligible patients had progressive CRPC adenocarcinoma of the prostate, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate hematologic, renal, and hepatic functions', '599 men', 'Data from three randomized phase III multicenter trials conducted by the Cancer and Leukemia Group B from 1992 to 1998 were combined']",[],"['pain interference scores', 'likelihood of prostate-specific antigen decline, objective response, and time to bone progression', 'Pain', 'overall survival', 'median survival times', 'pain interference scores and risk of death', 'Pain predicts overall survival', 'median pain interference scores']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.351002,"The median survival times were 17.6 months (95% CI, 16.1 to 19.1 months) and 10.2 months (95% CI, 8.6 to 11.3 months; P < .001) in men with low (< 17) and high (>or= 17) pain scores, respectively.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, and Cancer and Leukemia Group B Statistical Center, Durham, NC, USA. susan.halabi@duke.edu'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': ''}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'San-San', 'Initials': 'SS', 'LastName': 'Ou', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2007.15.0367']
3404,2527856,Lumbar facet joint syndrome. A randomised clinical trial.,"A group of 109 patients with unilateral low back pain for over three months were randomised to receive one of three types of injection treatment: cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline into two facet joints (42). The effect of the treatment was evaluated in relation to work attendance, pain, disability and movements of the lumbar spine. Patients were examined one hour and two and six weeks after treatment and also completed a questionnaire after three months. A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved. Of the 70 patients with initial pain relief after injection, 36% reported persisting benefit at the three month follow-up, independent of the mode of treatment given. We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain.",1989,"A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved.","['70 patients with', '109 patients with unilateral low back pain for over three months', 'Lumbar facet joint syndrome']","['cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline']","['work attendance, pain and disability scores', 'initial pain relief', 'lumbar spine', 'relation to work attendance, pain, disability and movements of the lumbar spine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0423690', 'cui_str': 'Facet joint pain (finding)'}]","[{'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0224521', 'cui_str': 'Facet Joint'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",109.0,0.0341784,"A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lilius', 'Affiliation': 'Helsinki University Central Hospital, Finland.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Laasonen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Myllynen', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Harilainen', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grönlund', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3405,22112793,Surrogate endpoints for prostate cancer-specific mortality after radiotherapy and androgen suppression therapy in men with localised or locally advanced prostate cancer: an analysis of two randomised trials.,"BACKGROUND


Androgen suppression therapy and radiotherapy are used to treat locally advanced prostate cancer. 3 years of androgen suppression confers a small survival benefit compared with 6 months of therapy in this setting, but is associated with more toxic effects. Early identification of men in whom radiotherapy and 6 months of androgen suppression is insufficient for cure is important. Thus, we assessed whether prostate-specific antigen (PSA) values can act as an early surrogate for prostate cancer-specific mortality (PCSM).
METHODS


We systematically reviewed randomised controlled trials that showed improved overall and prostate cancer-specific survival with radiotherapy and 6 months of androgen suppression compared with radiotherapy alone and measured lowest PSA concentrations (PSA nadir) and those immediately after treatment (PSA end). We assessed a cohort of 734 men with localised or locally advanced prostate cancer from two eligible trials in the USA and Australasia that randomly allocated participants between Feb 2, 1996, and Dec 27, 2001. We used Prentice criteria to assess whether reported PSA nadir or PSA end concentrations of more than 0·5 ng/mL were surrogates for PCSM.
FINDINGS


Men treated with radiotherapy and 6 months of androgen suppression in both trials were significantly less likely to have PSA end and PSA nadir values of more than 0·5 ng/mL than were those treated with radiotherapy alone (p<0·0001). Presence of candidate surrogates (ie, PSA end and PSA nadir values >0·5 ng/mL) alone and when assessed in conjunction with the randomised treatment group increased risk of PCSM in the US trial (PSA nadir p=0·0016; PSA end p=0·017) and Australasian trial (PSA nadir p<0·0001; PSA end p=0·0012). In both trials, the randomised treatment group was no longer associated with PCSM (p ≥ 0·20) when the candidate surrogates were included in the model. Therefore, both PSA metrics satisfied Prentice criteria for surrogacy.
INTERPRETATION


After radiotherapy and 6 months of androgen suppression, men with PSA end values exceeding 0·5 ng/mL should be considered for long-term androgen suppression and those with localised or locally advanced prostate cancer with PSA nadir values exceeding 0·5 ng/mL should be considered for inclusion in randomised trials investigating the use of drugs that have extended survival in castration-resistant metastatic prostate cancer.
FUNDING


None.",2012,"In both trials, the randomised treatment group was no longer associated with PCSM (p ≥ 0·20) when the candidate surrogates were included in the model.","['men with PSA end values exceeding 0·5', 'men with localised or locally advanced prostate cancer', '734 men with localised or locally advanced prostate cancer from two eligible trials in the USA and Australasia that randomly allocated participants between Feb 2, 1996, and Dec 27, 2001']","['radiotherapy and 6 months of androgen suppression compared with radiotherapy', 'radiotherapy', 'Androgen suppression therapy and radiotherapy', 'radiotherapy and androgen suppression therapy']","['PSA end and PSA nadir values', 'lowest PSA concentrations (PSA nadir', 'overall and prostate cancer-specific survival', 'risk of PCSM', 'PSA nadir or PSA end concentrations', 'toxic effects', 'androgen suppression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0282279', 'cui_str': 'Oceania'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",734.0,0.434772,"In both trials, the randomised treatment group was no longer associated with PCSM (p ≥ 0·20) when the candidate surrogates were included in the model.","[{'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': ""D'Amico"", 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA 02115, USA. adamico@partners.org""}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'de Castro', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Loffredo', 'Affiliation': ''}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Lamb', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(11)70295-9']
3406,31652241,Effects of Exergaming on Cognition and Gait in Older Adults at Risk for Falling.,"PURPOSE


To test whether an 8-wk exergaming (EG) program would improve cognition and gait characteristics compared with a traditional physical exercise (TPE) program in older adults at risk for falling.
METHODS


A pilot quasi-experimental study was conducted in adults age ≥65 yr at risk for falls, living in senior communities. Participants enrolled (n = 35) in either exercise program offered twice weekly for 8 wk. Cognition and single-task and dual-task gait characteristics were measured before and after the 8-wk exercise intervention. For each outcome, a repeated-measures ANCOVA adjusted for age, gender, and exercise intensity (ratings of perceived exertion, RPE) was used to examine the group-time interaction.
RESULTS


Twenty-nine participants (age, 77 ± 7 yr) completed either the EG program (n = 15) or the TPE program (n = 14). Statistically significant group-time interactions were observed in Trail Making Test Part A (P < 0.05) and single-task gait speed, stride length, swing time percentage, and double support percentage (all P < 0.05), and marginal group differences were observed in Mini-Mental State Examination (P = 0.07), all favoring the EG program. There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
CONCLUSIONS


An 8-wk EG program for older adults at risk for falls contributed to modest improvements in a number of cognitive measures and single-task but limited improvements in dual-task gait measures, compared with TPE. These findings support the need for larger trials to determine cognitive and mobility benefits related to EG.",2020,"There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
","['Twenty-nine participants (aged 77±7 yrs', 'older adults', 'Older Adults at Risk for Falling', 'older adults at risk for falling', 'adults aged ≥ 65 years at risk for falls, living in senior communities', 'Participants enrolled (N=35) in either']","['8-week exergaming (EG) program', 'traditional physical exercise (TPE) program', 'exercise program', 'TPE program', 'EG program']","['Cognition and single-task and dual-task gait characteristics', 'dual-task gait measures', 'cognition and gait characteristics', 'Cognition and Gait', 'dual-task gait measurements', 'Trail Making Test Part A (TMT-A, p<0.05) and single-task gait speed, stride length, swing time percentage, and double support percentage', 'Mini-Mental State Examination', 'exercise intensity (ratings of perceived exertion, RPE']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",29.0,0.0204178,"There were no statistically significant group differences in dual-task gait measurements except for swing time percentage and double support percentage, favoring the EG program.
","[{'ForeName': 'Elisa F', 'Initials': 'EF', 'LastName': 'Ogawa', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Haikun', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Computer Science, College of Science and Mathematics, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Lap-Fai', 'Initials': 'LF', 'LastName': 'Yu', 'Affiliation': 'Department of Computer Science, George Mason University, Fairfax, VA.'}, {'ForeName': 'Philimon N', 'Initials': 'PN', 'LastName': 'Gona', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Fleming', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Leveille', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}, {'ForeName': 'Tongjian', 'Initials': 'T', 'LastName': 'You', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002167']
3407,2187877,A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures.,"A total of 45 tibial shaft fractures, all conservatively treated and with union delayed for more than 16 but less than 32 weeks were entered in a double-blind multi-centre trial. The fractures were selected for their liability to delayed union by the presence of moderate or severe displacement, angulation or comminution or a compound lesion with moderate or severe injury to skin and soft tissues. Treatment was by plaster immobilisation in all, with active electromagnetic stimulation units in 20 patients and dummy control units in 25 patients for 12 weeks. Radiographs were assessed blindly and independently by a radiologist and an orthopaedic surgeon. Statistical analysis showed the treatment groups to be comparable except in their age distribution, but age was not found to affect the outcome and the effect of treatment was consistent for each age group. The radiologist's assessment of the active group showed radiological union in five fractures, progress to union in five but no progress to union in 10. In the control group there was union in one fracture and progress towards union in one but no progress in 23. Using Fisher's exact test, the results were very significantly in favour of the active group (p = 0.002). The orthopaedic surgeon's assessment showed union in nine fractures and absence of union in 11 fractures in the active group. There was union in three fractures and absence of union in 22 fractures in the control group. These results were also significantly in favour of the active group (p = 0.02). It was concluded that pulsed electromagnetic fields significantly influence healing in tibial fractures with delayed union.",1990,"Using Fisher's exact test, the results were very significantly in favour of the active group (p = 0.002).","['45 tibial shaft fractures, all conservatively treated and with union delayed for more than 16 but less than 32 weeks']",['pulsed electromagnetic fields'],"['tibial fractures', 'radiological union', 'delayed union of tibial fractures']","[{'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}]","[{'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}]",45.0,0.0276289,"Using Fisher's exact test, the results were very significantly in favour of the active group (p = 0.002).","[{'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Sharrard', 'Affiliation': 'Royal Hallamshire Hospital, Sheffield, England.'}]",The Journal of bone and joint surgery. British volume,[]
3408,30920874,Efficacy of injectable platelet-rich plasma in reducing alveolar bone resorption following rapid maxillary expansion:  A cone-beam computed tomography assessment in a randomized split-mouth controlled trial .,"OBJECTIVES


To evaluate the effectiveness of platelet-rich plasma (PRP) with its growth factors in minimizing the side effects of rapid maxillary expansion (RME) on the periodontal tissue of anchoring teeth using cone-beam computed tomography (CBCT).
MATERIALS AND METHODS


A randomized, split-mouth clinical trial was conducted on 18 patients aged 12-16 years (14 ± 1.65) with a skeletal maxillary constriction who underwent RME using a Hyrax appliance. The sample was randomly divided into two groups: intervention and control sides. PRP was prepared and injected on the buccal aspect of supporting teeth in the intervention group. High-resolution CBCT imaging (H-CBCT) was carried out preoperatively (T0) and after 3 months of retention (T1) to study the buccal bone plate thickness (BBPT) and buccal bone crest level (BBCL) of anchoring teeth. Changes induced by expansion were evaluated using paired sample  t -test ( P  < .05).
RESULTS


Results showed that there was no significant difference in BBPT and BBCL between the two groups after RME ( P  > .05). The prevalence of dehiscence and fenestrations was increased at (T1) in both groups and the percentage was higher in the PRP group.
CONCLUSIONS


RME induced vertical and horizontal bone loss. PRP did not minimize alveolar defects after RME.",2019,"The prevalence of dehiscence and fenestrations was increased at (T1) in both groups and the percentage was higher in the PRP group.
","['18 patients aged 12-16 years (14 ± 1.65) with a skeletal maxillary constriction who underwent RME using a Hyrax appliance', 'rapid maxillary expansion']","['High-resolution CBCT imaging (H-CBCT', 'platelet-rich plasma (PRP', 'PRP', 'injectable platelet-rich plasma']","['prevalence of dehiscence and fenestrations', 'buccal bone plate thickness (BBPT) and buccal bone crest level (BBCL', 'BBPT and BBCL', 'alveolar bone resorption', 'RME induced vertical and horizontal bone loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0020696', 'cui_str': 'Hyraxes'}, {'cui': 'C0243112'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0337280', 'cui_str': 'Fenestration - action (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0005971', 'cui_str': 'Bone plate, device (physical object)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C2948667', 'cui_str': 'Crest'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3805122', 'cui_str': 'Alveolar bone resorption'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",18.0,0.0365775,"The prevalence of dehiscence and fenestrations was increased at (T1) in both groups and the percentage was higher in the PRP group.
","[{'ForeName': 'Eyad B', 'Initials': 'EB', 'LastName': 'Alomari', 'Affiliation': ''}, {'ForeName': 'Kinda', 'Initials': 'K', 'LastName': 'Sultan', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/091018-661.1']
3409,2341458,The treatment of ingrowing toenails. A randomised comparison of wedge excision and phenol cauterisation.,"We treated 249 patients for ingrowing toenails in a prospective randomised study which compared wedge excision with segmental phenol cauterisation. Follow-up of 97% was at a minimum of 14 months. The analgesic requirement was significantly lower after phenol cauterisation (p less than 0.001), and significantly fewer patients needed to miss school or work (p = 0.001). Recurrence of ingrowth was seen in 16% after wedge excision and 9.6% after phenol cauterisation (not significant), but re-operation was significantly less frequent after phenol (p less than 0.01). Phenol cauterisation gives better short-term and long-term results than wedge resection.",1990,"The analgesic requirement was significantly lower after phenol cauterisation (p less than 0.001), and significantly fewer patients needed to miss school or work (p = 0.001).",['249 patients for ingrowing toenails'],"['Phenol cauterisation', 'wedge excision and phenol cauterisation', 'wedge excision with segmental phenol cauterisation']","['Recurrence of ingrowth', 'analgesic requirement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027343', 'cui_str': 'Nails, Ingrown'}]","[{'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0007471', 'cui_str': 'Cauterization'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",249.0,0.0132083,"The analgesic requirement was significantly lower after phenol cauterisation (p less than 0.001), and significantly fewer patients needed to miss school or work (p = 0.001).","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'van der Ham', 'Affiliation': 'Department of General Surgery, Sint Clara Ziekenhuis, Rotterdam, The Netherlands.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hackeng', 'Affiliation': ''}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Yo', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3410,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3411,32036479,The Physical Health Care Fidelity Scale: Psychometric Properties.,"Mental health programs need an instrument to monitor adherence to evidence-based physical health care for people with serious mental illness. The paper describes the Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility. Four fidelity assessments were conducted over 18 months at 13 sites randomized to implementation support for evidence-based physical health care. We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation. Programs were more successful in establishing Policies stating physical health care standards than in implementing these Policies. The Physical Health Care Fidelity Scale measures and guides implementation of evidence-based physical health care reliably.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.",2020,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.",['people with serious mental illness'],[],"['Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0222045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0236868,"We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation.","[{'ForeName': 'Torleif', 'Initials': 'T', 'LastName': 'Ruud', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway. torleif.ruud@medisin.uio.no.'}, {'ForeName': 'Tordis Sørensen', 'Initials': 'TS', 'LastName': 'Høifødt', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Delia Cimpean', 'Initials': 'DC', 'LastName': 'Hendrick', 'Affiliation': 'WestBridge, Manchester, NH, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'Westat, Lebanon, NH, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Høye', 'Affiliation': 'University Hospital Northern Norway, Tromsø, Norway.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Landers', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Kristin S', 'Initials': 'KS', 'LastName': 'Heiervang', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'Westat, Lebanon, NH, USA.'}]",Administration and policy in mental health,['10.1007/s10488-020-01019-0']
3412,31813388,"Increased consumption of calcium from fat-free milk, energy-restricted diet and educational activities improves metabolic control in overweight type 2 diabetic patients.","We assessed the effects of increased Ca consumption from fat-free milk in an energy-restricted diet and educational activities in the metabolic control of overweight type 2 diabetes mellitus (T2DM) patients. Fourteen subjects with T2DM (BMI 29·4 (sd 4·5) kg/m2, low habitual Ca consumption (<600 mg/d)) were included in this randomised, crossover clinical trial. Subjects were randomly allocated to one of the two interventions: drink containing 700 mg of Ca (DAIR) or drink containing 0 mg of Ca (CONT) for ninety consecutive days each. Energy-restricted diets (-500 kcal/d; -2092 kJ/d), containing 800 mg of Ca from dietary sources/d, were prescribed for both groups. Questionnaires were applied at baseline and at the end of the study to assess the subjects' knowledge on the disease and on self-care, biochemical variables and physical activity. Blood pressure, food intake, body composition and anthropometry were assessed at baseline, days 45 and 90. There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT. Uric acid, fasting glucose, Hb1Ac, parathyroid hormone and alanine aminotransferase concentrations reduced and vitamin D concentration increased after 90 d in DAIR compared with CONT. The consumption of energy-restricted diet containing 1200 mg Ca/d seems to favour metabolic control in subjects with T2DM. The educational activities increased the knowledge on the disease care.",2020,"There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT.","['overweight type 2 diabetic patients', 'subjects with T2DM', 'Fourteen subjects with T2DM', 'overweight type 2 diabetes mellitus (T2DM) patients']","['drink containing 700 mg of Ca (DAIR) or drink containing 0 mg of Ca (CONT', 'increased Ca consumption from fat-free milk in an energy-restricted diet and educational activities']","['Uric acid, fasting glucose, Hb1Ac, parathyroid hormone and alanine aminotransferase concentrations reduced and vitamin D concentration', 'body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure', 'Blood pressure, food intake, body composition and anthropometry']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0013652', 'cui_str': 'Educational Activities'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2828149', 'cui_str': 'Supine Abdominal Height'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",14.0,0.0171495,"There was a higher reduction of body fat %, waist circumference, hip circumference, neck circumference, waist:hip ratio, sagittal abdominal diameter, diastolic/systolic blood pressure and an increase in fat-free mass % in DAIR than in CONT.","[{'ForeName': 'Jorge de Assis', 'Initials': 'JA', 'LastName': 'Costa', 'Affiliation': 'Instituto Federal do Sudeste de Minas Gerais (UEMG) - Campus Barbacena, Barbacena, Minas GeraisCEP 36205-018, Brazil.'}, {'ForeName': 'Júnia Maria Geraldo', 'Initials': 'JMG', 'LastName': 'Gomes', 'Affiliation': 'Instituto Federal do Sudeste de Minas Gerais (UEMG) - Campus Barbacena, Barbacena, Minas GeraisCEP 36205-018, Brazil.'}, {'ForeName': 'Priscila Vaz de Melo', 'Initials': 'PVM', 'LastName': 'Ribeiro', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas GeraisCEP 36570-000, Brazil.'}, {'ForeName': 'Rita de Cássia Gonçalves', 'Initials': 'RCG', 'LastName': 'Alfenas', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, Minas GeraisCEP 36570-000, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519003192']
3413,31416745,The effect of minocycline on amelioration of cognitive deficits and pro-inflammatory cytokines levels in patients with schizophrenia.,"BACKGROUND


Cognitive deficits of schizophrenia are predictors of poor function, but antipsychotic medication has limited efficacy for cognitive deficits. These deficits in learning and memory may result from activity of pro-inflammatory cytokines, which microglia produce. The microglia inhibitor minocycline might arrest this cytokine damage to the hippocampus and reverse the cognitive deficits of schizophrenia.
METHODS


A double-blind, placebo-controlled study involved 75 patients with schizophrenia who randomly received low dose (100 mg/day) or high dose minocycline (200 mg/day) or placebo added to risperidone. MATRICS Consensus Cognitive Battery (MCCB) was used to assess the cognitive functioning, and serum levels of Interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) were assessed.
RESULTS


Minocycline high dose  group was significantly superior to minocycline low dose  or placebo group not only for the improvements in cognitive tests' scores as well (P < 0.05), but for IL-1β and IL-6 serum levels reduction (P < 0.01). The amelioration of cognitive deficits with minocycline correlated not only with the remission of negative symptoms, but also with the reduction in serum levels of IL-1β and IL-6.
CONCLUSIONS


Minocycline adjunctive treatment was effective in improving cognitive deficits of patients with schizophrenia. The beneficial effect of minocycline may be related to reducing pro-inflammatory cytokines through microglia inhibition.",2019,"RESULTS


Minocycline high dose  group was significantly superior to minocycline low dose  or placebo group not only for the improvements in cognitive tests' scores as well (P < 0.05), but for IL-1β and IL-6 serum levels reduction (P < 0.01).","['patients with schizophrenia', '75 patients with schizophrenia']","['risperidone', 'placebo', 'Minocycline', 'Minocycline adjunctive treatment', 'minocycline']","['cognitive deficits', 'IL-1β and IL-6 serum levels reduction', 'serum levels of IL-1β and', 'amelioration of cognitive deficits', 'cognitive deficits and pro-inflammatory cytokines levels', ""cognitive tests' scores"", 'cognitive functioning, and serum levels of Interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",75.0,0.121687,"RESULTS


Minocycline high dose  group was significantly superior to minocycline low dose  or placebo group not only for the improvements in cognitive tests' scores as well (P < 0.05), but for IL-1β and IL-6 serum levels reduction (P < 0.01).","[{'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Psychiatry and Mental Health Institute of the Second Xiangya Hospital, Central South University; Chinese National Clinical Research Center on Mental Disorders, Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, Changsha, Hunan, China; Department of Psychiatry, Guangzhou First People's Hospital, the Second Affiliated Hospital, South China University of Technology, Guangzhou, Guangdong, China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'GuangzhouBaiyun Psychiatric Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Rengrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Mental Health Institute of the Second Xiangya Hospital, Central South University; Chinese National Clinical Research Center on Mental Disorders, Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, Changsha, Hunan, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, TX, USA.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychiatry and Mental Health Institute of the Second Xiangya Hospital, Central South University; Chinese National Clinical Research Center on Mental Disorders, Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, Changsha, Hunan, China; The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Huiai Hospital, Guangzhou, Guangdong, China. Electronic address: zhaojingping@csu.edu.cn.'}]",Schizophrenia research,['10.1016/j.schres.2019.08.005']
3414,2071654,Axial movement and tibial fractures. A controlled randomised trial of treatment.,"Diaphyseal fractures of the tibia in 80 patients were treated by external skeletal fixation using a unilateral frame, either in a fixed mode or in a mode which allowed the application of a small amount of predominantly axial micromovement. Patients were allocated to each regime by random selection. Fracture healing was assessed clinically, radiologically and by measurement of the mechanical stiffness of the fracture. Both clinical and mechanical healing were enhanced in the group subjected to micromovement, compared to those treated with frames in a fixed mode possessing an overall stiffness similar to that of others in common clinical use. The differences in healing time were statistically significant and independently related to the treatment method. There was no difference in complication rates between treatment groups.",1991,"Both clinical and mechanical healing were enhanced in the group subjected to micromovement, compared to those treated with frames in a fixed mode possessing an overall stiffness similar to that of others in common clinical use.",['Diaphyseal fractures of the tibia in 80 patients'],['external skeletal fixation'],"['Axial movement and tibial fractures', 'mechanical healing', 'Fracture healing', 'healing time', 'complication rates']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}]","[{'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",80.0,0.0235688,"Both clinical and mechanical healing were enhanced in the group subjected to micromovement, compared to those treated with frames in a fixed mode possessing an overall stiffness similar to that of others in common clinical use.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kenwright', 'Affiliation': 'Nuffield Orthopaedic Centre, Oxford, England.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Cunningham', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Goodship', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Magnussen', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Newman', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3415,1894676,Need the thumb be immobilised in scaphoid fractures? A randomised prospective trial.,"Immobilisation of the thumb is widely believed to be important in the management of fractures of the carpal scaphoid. To assess the need for this, we randomly allocated 392 fresh fractures for treatment by either a forearm gauntlet (Colles') cast, leaving the thumb free, or by a conventional 'scaphoid' plaster incorporating the thumb as far as its interphalangeal joint. In the 292 fractures which were followed for six months, the incidence of nonunion was independent of the type of cast used.",1991,Immobilisation of the thumb is widely believed to be important in the management of fractures of the carpal scaphoid.,[],"[""forearm gauntlet (Colles') cast, leaving the thumb free, or by a conventional 'scaphoid' plaster""]",['incidence of nonunion'],[],"[{'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}]",392.0,0.0243756,Immobilisation of the thumb is widely believed to be important in the management of fractures of the carpal scaphoid.,"[{'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Clay', 'Affiliation': ""Queen's Medical Centre, Nottingham, England.""}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': ''}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Costigan', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Gregg', 'Affiliation': ''}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Barton', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3416,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3417,2005162,Unstable Colles' fractures in elderly patients. A randomised trial of external fixation for redisplacement.,"We report the results of a prospective randomised controlled trial of the management of 101 Colles' fractures in patients over the age of 55 years. Within two weeks of initial reduction 43 fractures had displaced with either more than 10 degrees dorsal angulation or more than 5 mm radial shortening. These patients were randomly divided into two groups: 21 were remanipulated and held by an external fixator; in the control group of 22 patients, the redisplacement was accepted and conservative treatment was continued. Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group. We found no correlation between final anatomical and functional outcome, and concluded that the severity of the original soft-tissue injury and its complications are the major determinants of functional end result.",1991,"Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group.","[""Unstable Colles' fractures in elderly patients"", ""101 Colles' fractures in patients over the age of 55 years""]",['external fixation'],[],"[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}]",[],,0.0128574,"Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group.","[{'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Roumen', 'Affiliation': 'Department of General Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'W L', 'Initials': 'WL', 'LastName': 'Hesp', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Bruggink', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3418,2111327,Combined treatment with indomethacin and low-dose heparin after total hip replacement. A double-blind placebo-controlled clinical trial.,"We studied the safety of combining the postoperative use of a non-steroidal anti-inflammatory drug with low-dose heparin. In a double-blind, placebo-controlled clinical trial we reviewed the complications in 235 patients after total hip replacement, all treated with low-dose heparin and either indomethacin or a placebo. The incidence and type of complications in the two groups were nearly equal; indomethacin-treated patients had no increase in complications related to bleeding. Postoperative bleeding into drains was marginally greater in the indomethacin group, although the difference was not statistically significant. We conclude that treatment with indomethacin and low-dose heparin after hip replacement does not significantly increase the bleeding or other complications. We also found that patients receiving indomethacin were mobilised an average of one day before those on placebo.",1990,The incidence and type of complications in the two groups were nearly equal; indomethacin-treated patients had no increase in complications related to bleeding.,"['235 patients after total hip replacement, all treated with low-dose', 'after total hip replacement']","['indomethacin and low-dose heparin', 'placebo', 'heparin', 'indomethacin', 'heparin and either indomethacin or a placebo', 'non-steroidal anti-inflammatory drug with low-dose heparin']","['bleeding or other complications', 'Postoperative bleeding into drains', 'incidence and type of complications', 'complications related to bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.228733,The incidence and type of complications in the two groups were nearly equal; indomethacin-treated patients had no increase in complications related to bleeding.,"[{'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Kristensen', 'Affiliation': 'Kolding Hospital, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pedersen', 'Affiliation': ''}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Pedersen', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kjaersgaard-Andersen', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3419,31601111,Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial.,"BACKGROUND


No recognized standards exist for teaching patients and their caregivers ventricular assist device (VAD) self-care skills. We compared the effectiveness of a VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training.
METHODS AND RESULTS


VAD patients and their caregivers were randomized to SBML or usual training during their implant hospitalization. The SBML group completed a pretest on 3 VAD self-care skills (controller, power source, and dressing change), then viewed videos and participated in deliberate practice on a simulator. SBML participants took a posttest and were required to meet or exceed a minimum passing standard for each of the skills. The usual training group completed the existing institutional VAD self-care teaching protocol. Before hospital discharge, the SBML and usual training groups took the same 3 VAD self-care skills tests. We compared demographic and clinical information, self-confidence, total participant training time, and skills performance between groups. Forty participants completed the study in each group. There were no differences in demographic and clinical information, self-confidence, or training time between groups. More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
CONCLUSIONS


SBML provided superior VAD self-care skills learning outcomes compared with usual training. This study has important implications for patients due to the morbidity and mortality associated with improper VAD self-care.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT03073005.",2019,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
","['Assist Device Self-Care Skills', 'Forty participants completed the study in each group', 'VAD patients and their caregivers']","['Simulation-Based Mastery Learning', 'VAD simulation-based mastery learning (SBML) self-care training curriculum with usual VAD self-care training', 'SBML or usual training during their implant hospitalization', 'usual training group completed the existing institutional VAD self-care teaching protocol']","['dressing change skills', 'demographic and clinical information, self-confidence, total participant training time, and skills performance', 'demographic and clinical information, self-confidence, or training time']","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",40.0,0.0660624,"More participants in the SBML group met the minimum passing standard compared with the usual training group for controller (37/40 [93%] versus 25/40 [63%];  P =0.001), power source (36/40 [90%] versus 9/40 [23%];  P <0.001), and dressing change skills (19/20 [95%] versus 0/20;  P <0.001).
","[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Barsuk', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Wilcox', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elaine R', 'Initials': 'ER', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Harap', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Shanklin', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Gretchen P', 'Initials': 'GP', 'LastName': 'Nonog', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schulze', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Jirak', 'Affiliation': 'Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL (J.E.W., R.S.H., K.B.S., G.P.N., L.E.S., A.M.J.).'}, {'ForeName': 'Diane B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Department of Medicine (J.H.B., J.E.W., E.R.C., K.L.G., J.S.K., D.B.W., K.A.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005794']
3420,2005167,Fixation of intertrochanteric fractures of the femur. A randomised prospective comparison of the gamma nail and the dynamic hip screw.,"We have prospectively compared the fixation of 100 intertrochanteric fractures of the proximal femur in elderly patients with random use of either a Dynamic Hip Screw (DHS) or a new intramedullary device, the Gamma nail. We found no difference in operating time, blood loss, wound complications, stay in hospital, place of eventual discharge, or the patients' mobility at final review. There was no difference in failure of proximal fixation: cut-out occurred in three cases with the DHS, and twice with the Gamma nail. However, in four cases fracture of the femur occurred close to the Gamma nail, requiring further major surgery. In the absence of these complications, union was seen by six months in both groups.",1991,"We found no difference in operating time, blood loss, wound complications, stay in hospital, place of eventual discharge, or the patients' mobility at final review.",['100 intertrochanteric fractures of the proximal femur in elderly patients with random use of either a'],"['gamma nail and the dynamic hip screw', 'Dynamic Hip Screw (DHS) or a new intramedullary device, the Gamma nail']","[""operating time, blood loss, wound complications, stay in hospital, place of eventual discharge, or the patients' mobility"", 'failure of proximal fixation: cut-out']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1096106'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}]",100.0,0.0128474,"We found no difference in operating time, blood loss, wound complications, stay in hospital, place of eventual discharge, or the patients' mobility at final review.","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Bridle', 'Affiliation': 'St Georges Hospital, Tooting, London, England.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bircher', 'Affiliation': ''}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Calvert', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3421,2005168,Coccydynia. Aetiology and treatment.,A five-year prospective trial involving 120 patients was undertaken to investigate the aetiology and treatment of coccydynia. The cause lies in some localised musculoskeletal abnormality in the coccygeal region. Lumbosacral disc prolapse is not a significant factor. The condition is genuine and distressing and we found no evidence of neurosis in our patients. Physiotherapy was of little help in treatment but 60% of patients responded to local injections of corticosteroid and local anaesthesia. Manipulation and injection was even more successful and cured about 85%. Coccygectomy was required in almost 20% and had a success rate of over 90%.,1991,Lumbosacral disc prolapse is not a significant factor.,['120 patients'],[],"['Lumbosacral disc prolapse', 'success rate']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0450206', 'cui_str': 'Lumbosacral (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",120.0,0.0348611,Lumbosacral disc prolapse is not a significant factor.,"[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Wray', 'Affiliation': 'Department of Orthopaedic Surgery, Leicester Royal Infirmary, England.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Easom', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hoskinson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3422,1906472,Postoperative blood salvage in total hip and knee arthroplasty. A randomised controlled trial.,"We undertook a prospective controlled clinical trial of 109 patients to determine whether postoperative blood salvage in patients undergoing total hip or knee arthroplasty decreased the need for transfusion with banked blood. The average amount of blood collected in our series was 493 ml, most of which was collected in the first four postoperative hours. In patients undergoing bilateral total knee arthroplasty, there was a 54% reduction in banked blood utilisation. None of our patients developed adverse effects from the reinfused material. The cost of collecting and processing wound drainage using the Haemolite cell washer was $175 per patient, regardless of the volume processed, compared to $125 for a unit of banked blood. By reducing the requirement for homologous transfusion, blood salvage diminishes the risks of transmission of HIV and hepatitis viruses. In those cases where the equivalent of two units of blood are reinfused, blood salvage saves money. However, due to the small amounts of blood collected in unilateral hip or knee arthroplasty, we do not recommend its routine application in these cases.",1991,"In patients undergoing bilateral total knee arthroplasty, there was a 54% reduction in banked blood utilisation.","['109 patients', 'total hip and knee arthroplasty', 'patients undergoing bilateral total knee arthroplasty', 'patients undergoing total hip or knee arthroplasty decreased the need for transfusion with banked blood']",['postoperative blood salvage'],"['adverse effects', 'banked blood utilisation', 'Postoperative blood salvage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0005768'}]","[{'cui': 'C2936225', 'cui_str': 'Post-Operative Blood Salvage'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0005768'}, {'cui': 'C2936225', 'cui_str': 'Post-Operative Blood Salvage'}]",109.0,0.0266412,"In patients undergoing bilateral total knee arthroplasty, there was a 54% reduction in banked blood utilisation.","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Slagis', 'Affiliation': 'University of Arizona Health Sciences Center, Tucson 85724.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Benjamin', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Volz', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Giordano', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3423,1732266,Walking ability after total hip replacement. A comparison of gait analysis in unilateral and bilateral cases.,"We studied 50 patients before and after unilateral total hip replacement, and compared them, using gait analysis, with 22 having staged bilateral operations. The average age of the patients was 65 years at the first operation. The mean follow-up was 53 months for the unilateral cases and 27 months, after the second THR, for the bilateral cases. The average interval between first and second THR was 24 months. Patients with bilateral hip disease did not gain optimal function, even on the first side, until both hips had been replaced. Unilateral replacement gave better gait analysis results than did either side after bilateral procedures.",1992,Unilateral replacement gave better gait analysis results than did either side after bilateral procedures.,"['Patients with bilateral hip disease', '50 patients before and after unilateral total hip replacement, and compared them, using gait analysis, with 22 having staged bilateral operations', 'unilateral and bilateral cases']",[],['Walking ability'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0558820', 'cui_str': 'Gait Analysis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],"[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}]",50.0,0.0117118,Unilateral replacement gave better gait analysis results than did either side after bilateral procedures.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wykman', 'Affiliation': 'Department of Orthopaedics, Karolinska Hospital, Stockholm, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Olsson', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3424,31932574,Evaluation of a Three-Dimensional Printed Guide and a Polyoxymethylene Thermoplastic Regulator for Percutaneous Pedicle Screw Fixation in Patients with Thoracolumbar Fracture.,"BACKGROUND This study aimed to evaluate the efficacy of a porous polyoxymethylene thermoplastic regulator combined with a three-dimensional (3D) printed template to guide pedicle needle insertion in patients undergoing percutaneous pedicle screw fixation (PPSF) for thoracolumbar fracture. MATERIAL AND METHODS Forty patients were randomly divided into group A, treated using a porous polyoxymethylene thermoplastic regulator combined with a 3D printed template, and group B, who underwent conventional PPSF. Data recorded included the number of pedicle screws successfully inserted on the first attempt, the number of attempts, the time to successful needle insertion, the total time of fluoroscopy, and the duration of surgery. The Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI) scores one day before surgery, and at day 1, day 7, month 1, and month 3 after surgery were recorded. The postoperative vertebral posterior kyphotic angle (KA) and the rate of change of KA were recorded. RESULTS Group A had a significantly increased total number of successful first insertions compared with group BV (P<0.05). Postoperative VAS and ODI scores of patients in both groups were significantly lower than before surgery (P<0.05), with no significant difference between the two groups at postoperative month 1 and month 3 (P>0.05). The postoperative vertebral posterior KA decreased significantly in both groups after surgery, with no significant difference between the two groups (P>0.05). CONCLUSIONS The use of a porous polyoxymethylene thermoplastic regulator combined with a 3D printed template may improve the success of pedicle insertion in patients undergoing PPSF.",2020,RESULTS Group A had a significantly increased total number of successful first insertions compared with group BV (P<0.05).,"['patients undergoing', 'Forty patients', 'patients undergoing PPSF', 'Patients with Thoracolumbar Fracture']","['Percutaneous Pedicle Screw Fixation', 'percutaneous pedicle screw fixation (PPSF', 'porous polyoxymethylene thermoplastic regulator combined with a 3D printed template, and group B, who underwent conventional PPSF', 'porous polyoxymethylene thermoplastic regulator combined with a three-dimensional (3D) printed template to guide pedicle needle insertion']","['postoperative vertebral posterior KA', 'postoperative vertebral posterior kyphotic angle (KA) and the rate of change of KA', 'total number of successful first insertions', 'total time of fluoroscopy, and the duration of surgery', 'success of pedicle insertion', 'Postoperative VAS and ODI scores', 'Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI) scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0057306', 'cui_str': 'delrin homopolymer'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439630', 'cui_str': 'First insertion (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}]",40.0,0.0360313,RESULTS Group A had a significantly increased total number of successful first insertions compared with group BV (P<0.05).,"[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Fang', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedic Surgery, The Second Peoples' Hospital of Huai'an, Xuzhou Medical University, Huai'an, Jiangsu, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.920578']
3425,32022904,Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial.,"BACKGROUND


Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation fluid has been reported to reduce the risk of worsening of AKI. Restrictive fluid therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-the REVERSE-AKI trial that compares a restrictive fluid therapy regimen to standard therapy in critically ill patients with AKI.
METHODS


REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive fluid treatment regimen vs standard management. In the restrictive fluid therapy regimen, the daily fluid balance target is neutral or negative. The primary outcome is the cumulative fluid balance assessed after 72 hours from randomization. Secondary outcomes include safety, feasibility, duration, and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
CONCLUSIONS


This is the first multinational trial investigating the feasibility and safety of a restrictive fluid therapy regimen in critically ill patients with AKI.
TRIAL REGISTRATION


clinical.trials.gov NCT03251131.",2020,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
","['Acute Kidney Injury', '100 critically ill patients with AKI to a restrictive fluid treatment regimen versus standard management', 'septic shock patients', '7 ICUs in 5 countries', 'critically ill patients with AKI']",['restrictive fluid therapy regimen'],"['safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence', 'cumulative fluid balance']","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}]",100.0,0.24103,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence).
","[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Selander', 'Affiliation': 'Science Service Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Elettra', 'Initials': 'E', 'LastName': 'Poli', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hoste', 'Affiliation': 'Intensive Care Unit, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Australian National University Medical School, Canberra, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Prowle', 'Affiliation': 'Critical Care and Preoperative Medicine Research Group, Centre for Translational Medicine and Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13557']
3426,1587874,Gamma nails and dynamic hip screws for peritrochanteric fractures. A randomised prospective study in elderly patients.,"The Gamma nail was introduced for the treatment of peritrochanteric fractures with the theoretical advantage of a load-sharing femoral component which could be implanted by a closed procedure. We report a randomised prospective study of 186 fractures treated by either the Gamma nail or a dynamic hip screw. Gamma nails were implanted with significantly shorter screening times, smaller incisions, and less intraoperative bleeding. The Gamma nail group had a shorter convalescence and earlier full weight-bearing, but there was no significant difference in mortality within six months, postoperative mobility, or hip function at review. More intra-operative complications were recorded in the Gamma nail group, mainly due to the mismatching of the femoral component of the nail to the small femurs of Chinese people. Use of a smaller modified nail reduced these complications. We conclude that with careful surgical technique and the modified femoral component, the Gamma nail is an advance in the treatment of peritrochanteric fractures.",1992,"More intra-operative complications were recorded in the Gamma nail group, mainly due to the mismatching of the femoral component of the nail to the small femurs of Chinese people.","['peritrochanteric fractures', 'elderly patients', '186 fractures treated by either the']","['Gamma nails and dynamic hip screws', 'Gamma nail or a dynamic hip screw']","['intraoperative bleeding', 'shorter convalescence and earlier full weight-bearing', 'intra-operative complications', 'mortality within six months, postoperative mobility, or hip function']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0677614'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0031843', 'cui_str': 'function'}]",186.0,0.0111677,"More intra-operative complications were recorded in the Gamma nail group, mainly due to the mismatching of the femoral component of the nail to the small femurs of Chinese people.","[{'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Leung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'W S', 'Initials': 'WS', 'LastName': 'So', 'Affiliation': ''}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Hui', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3427,1732238,"Partial versus total meniscectomy. A prospective, randomised study with long-term follow-up.","Two hundred patients with a meniscal lesion were peroperatively allocated to partial or total meniscectomy in a random manner. The results were compared at one year and at 6.3 to 9.8 years (median 7.8). After one year more patients with partial meniscectomy (90%) than with total meniscectomy (80%) had no complaints. At the later review these figures were 62% and 52%, respectively (p = 0.18). However, patients with partial meniscectomy had higher functional scores. The deterioration in function between the first review and the second showed no significant difference in the two treatment groups. The incidence of mediolateral instability rose from 8% to 47% and was more frequent after total than after partial meniscectomy. Between the two reviews the radiological signs of knee degeneration increased with no difference between the two treatment groups.",1992,The incidence of mediolateral instability rose from 8% to 47% and was more frequent after total than after partial meniscectomy.,['Two hundred patients with a meniscal lesion'],[],"['functional scores', 'incidence of mediolateral instability', 'radiological signs of knee degeneration']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}]",200.0,0.0187559,The incidence of mediolateral instability rose from 8% to 47% and was more frequent after total than after partial meniscectomy.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hede', 'Affiliation': 'Gentofte Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sandberg', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3428,1732264,A venous foot pump reduces thrombosis after total hip replacement.,"In a prospective, randomised controlled trial, the efficacy of the A-V Impulse System in the prevention of deep-vein thrombosis was investigated in 84 patients who had undergone total hip replacement. The incidence of venographically proven, and clinically significant postoperative deep-vein thrombosis was 40% in the control group and 5% in the treatment group (p less than 0.001). No adverse reactions were recorded.",1992,"The incidence of venographically proven, and clinically significant postoperative deep-vein thrombosis was 40% in the control group and 5% in the treatment group (p less than 0.001).","['84 patients who had undergone total hip replacement', 'total hip replacement']",['A-V Impulse System'],"['adverse reactions', 'deep-vein thrombosis', 'postoperative deep-vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]","[{'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0589110', 'cui_str': 'Postoperative deep vein thrombosis (disorder)'}]",84.0,0.0717436,"The incidence of venographically proven, and clinically significant postoperative deep-vein thrombosis was 40% in the control group and 5% in the treatment group (p less than 0.001).","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Fordyce', 'Affiliation': 'Princess Elizabeth Orthopaedic Hospital, Exeter, Devon, England.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Ling', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3429,1732265,Thrombo-embolic prophylaxis in total knee replacement. Evaluation of the A-V Impulse System.,"We performed a prospective randomised controlled trial of a new mechanical method of prophylaxis for venous thrombo-embolism in 60 patients undergoing knee replacement surgery. The method uses the A-V Impulse System to produce cyclical compression of the venous reservoir of the foot. The overall incidence of deep-vein thrombosis was 68.7% in patients receiving no prophylaxis and 50% in those using the device. The difference was not significant. There was, however, a reduction of the extent of thrombosis in the treated group. There were 13 major calf-vein thrombi and six proximal-vein thrombi in the control group compared with only five major calf-vein thrombi in the treated group. This difference was significant (p = 0.014). No patient developed clinical features of a pulmonary embolism.",1992,The overall incidence of deep-vein thrombosis was 68.7% in patients receiving no prophylaxis and 50% in those using the device.,"['total knee replacement', '60 patients undergoing knee replacement surgery']","['new mechanical method of prophylaxis', 'Thrombo-embolic prophylaxis']","['extent of thrombosis', '13 major calf-vein thrombi and six proximal-vein thrombi', 'overall incidence of deep-vein thrombosis']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",60.0,0.0308709,The overall incidence of deep-vein thrombosis was 68.7% in patients receiving no prophylaxis and 50% in those using the device.,"[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Wilson', 'Affiliation': ""Department of Orthopaedic Surgery, King's College Hospital, London, England.""}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Kakkar', 'Affiliation': ''}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Maurice', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Smibert', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Nixon', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3430,1670442,Prevention of deep vein thrombosis after total hip replacement. The effect of low-molecular-weight heparin with spinal and general anaesthesia.,"Enoxaparin, a low-molecular-weight heparin, has been used together with spinal or general anaesthesia in a prospective, randomised study of 188 consecutive elective hip replacements. Bilateral venography was performed on all patients on day 13 after operation. Group I (65 patients) received spinal anaesthesia and no immediate injection of enoxaparin. Group II (61 patients) received spinal anaesthesia and 20 mg of enoxaparin one hour after the onset of anaesthesia. Group III (62 patients) was operated on under general anaesthesia and received 40 mg of enoxaparin 12 hours prior to surgery. This group acted as the control group. In all three groups, 40 mg of enoxaparin was given 12 hours after the end of surgery and continued on a once-daily basis. Proximal DVT occurred in 6% of group I, 6.7% of group II and 6.5% of group III, not a significant difference. Distal DVT was present in 11% of group I, 5% of group II and 0% of group III; this was a highly significant difference (p = 0.007). Tolerance was good and the incidence of bleeding low in the three groups. Our results confirm the low rate of DVT in patients operated on under general anaesthesia with the standard procedure of 40 mg of enoxaparin on a once-daily basis started pre-operatively. The 40 mg-dose is also safe and effective in association with spinal anaesthesia if half the dose (20 mg) is injected an hour after the lumbar puncture.",1991,"Proximal DVT occurred in 6% of group I, 6.7% of group II and 6.5% of group III, not a significant difference.","['deep vein thrombosis after total hip replacement', '188 consecutive elective hip replacements']","['Bilateral venography', 'low-molecular-weight heparin with spinal and general anaesthesia', 'spinal anaesthesia and 20 mg of enoxaparin', 'Enoxaparin', 'spinal anaesthesia and no immediate injection of enoxaparin', 'enoxaparin']","['Proximal DVT', 'incidence of bleeding low', 'low rate of DVT', 'Distal DVT']","[{'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",188.0,0.0128464,"Proximal DVT occurred in 6% of group I, 6.7% of group II and 6.5% of group III, not a significant difference.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Planès', 'Affiliation': 'Department of Orthopaedic Surgery, Clinique Radio Chirurgicale du Mail, La Rochelle, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vochelle', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fagola', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Feret', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellaud', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3431,1659570,Biodegradable pin fixation of elbow fractures in children. A randomised trial.,"A prospective randomised clinical trial was undertaken to compare biodegradable polyglycolic acid pins with standard Kirschner wires used to fix displaced elbow fractures in children. Twenty-four children were enrolled in the trial; 14 had fractures of the lateral condyle of the humerus, eight of the medial epicondyle and two had olecranon fractures. Eleven fractures were fixed with Kirschner wires and 13 with polyglycolic acid pins. Fracture union with full function occurred in all cases within six months. Kirschner wires caused problems including infection in three cases, soft-tissue ossification in one and they required removal under general anaesthesia in nine cases. No such complications occurred with polyglycolic acid pins but one patient in this group developed avascular necrosis and premature fusion of the medial epicondyle.",1991,No such complications occurred with polyglycolic acid pins but one patient in this group developed avascular necrosis and premature fusion of the medial epicondyle.,"['Twenty-four children were enrolled in the trial; 14 had fractures of the lateral condyle of the humerus, eight of the medial epicondyle and two had olecranon fractures', 'elbow fractures in children', 'children']","['Kirschner wires', 'Kirschner wires and 13 with polyglycolic acid pins', 'Biodegradable pin fixation', 'biodegradable polyglycolic acid pins with standard Kirschner wires', 'polyglycolic acid pins']","['Fracture union with full function', 'avascular necrosis and premature fusion of the medial epicondyle']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0020164', 'cui_str': 'Humerus'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0555335', 'cui_str': 'Fracture of olecranon (disorder)'}, {'cui': 'C0600106', 'cui_str': 'Elbow fracture (disorder)'}]","[{'cui': 'C0086510', 'cui_str': 'Kirschner Wires'}, {'cui': 'C0032502', 'cui_str': 'Polyglycolide'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3887513', 'cui_str': 'Avascular necrosis (morphologic abnormality)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}]",24.0,0.01524,No such complications occurred with polyglycolic acid pins but one patient in this group developed avascular necrosis and premature fusion of the medial epicondyle.,"[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Hope', 'Affiliation': ""Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Cole', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3432,32017251,Effects of providing nursing care with web-based program on maternal self-efficacy and infant health.,"OBJECTIVE


The study was conducted to examine the efficacy of a web-based program, informed by Pender's Health Promotion Model, given to primiparous women on the growth and development of infant, infants' health, and women's self-efficacy level.
METHODS


This randomized controlled study with a posttest design was conducted in three primary care clinics. The study group comprised 71 primiparous women and their infants (intervention group: N = 35; control group: N = 36). The women who are at the 33-37th gestational week in the intervention group participated in the web-based program. They completed four education modules. Women in the control group received routine care in clinics. Data forms were completed in the first week and first, second, and third months postpartum. Breastfeeding status, weight, head circumference, development of infants and women's self-efficacy were evaluated in the postnatal period up to 3 months.
RESULTS


In the intervention group, the ratio of infants who were exclusively breastfed was higher compared to the control group. The mean scores for the LATCH instrument which measures breastfeeding status and Parental Self-Efficacy Scale, were significantly higher in the intervention compared to the control group (p < .05).
CONCLUSION


The women who participated in the web-based program demonstrated better self-efficacy and their infants demonstrated better scores on measures of growth, development, and health than those in the control group.",2020,"The mean scores for the LATCH instrument which measures breastfeeding status and Parental Self-Efficacy Scale, were significantly higher in the intervention compared to the control group (p < .05).
","['three primary care clinics', 'women who are at the 33-37th gestational week in the intervention group participated in the web-based program', '71 primiparous women and their infants (intervention group: N\xa0=\xa035; control group: N\xa0=\xa036', ""primiparous women on the growth and development of infant, infants' health, and women's self-efficacy level""]","['routine care', 'nursing care with web-based program']","['self-efficacy', 'measures of growth, development, and health', 'breastfeeding status and Parental Self-Efficacy Scale', 'maternal self-efficacy and infant health', ""Breastfeeding status, weight, head circumference, development of infants and women's self-efficacy""]","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1457898', 'cui_str': 'growth & development'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",71.0,0.0179199,"The mean scores for the LATCH instrument which measures breastfeeding status and Parental Self-Efficacy Scale, were significantly higher in the intervention compared to the control group (p < .05).
","[{'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Sari', 'Affiliation': 'Gazi University, Health Sciences Faculty, Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Naime', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Gazi University, Health Sciences Faculty, Nursing Department, Ankara, Turkey.'}]","Public health nursing (Boston, Mass.)",['10.1111/phn.12712']
3433,32019854,"Targeting CXCR1/2 Does Not Improve Insulin Secretion After Pancreatic Islet Transplantation: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial in Type 1 Diabetes.","OBJECTIVE


Reparixin is an inhibitor of CXCR1/2 chemokine receptor shown to be an effective anti-inflammatory adjuvant in a pilot clinical trial in allotransplant recipients.
RESEARCH DESIGN AND METHODS


A phase 3, multicenter, randomized, double-blind, parallel-assignment study (NCT01817959) was conducted in recipients of islet allotransplants randomized (2:1) to reparixin or placebo in addition to immunosuppression. Primary outcome was the area under the curve (AUC) for C-peptide during the mixed-meal tolerance test at day 75 ± 5 after the first and day 365 ± 14 after the last transplant. Secondary end points included insulin independence and standard measures of glycemic control.
RESULTS


The intention-to-treat analysis did not show a significant difference in C-peptide AUC at both day 75 (27 on reparixin vs. 18 on placebo,  P  = 0.99) and day 365 (24 on reparixin vs. 15 on placebo,  P  = 0.71). There was no statistically significant difference between treatment groups at any time point for any secondary variable. Analysis of patient subsets showed a trend for a higher percentage of subjects retaining insulin independence for 1 year after a single islet infusion in patients receiving reparixin as compared with patients receiving placebo (26.7% vs. 0%,  P  = 0.09) when antithymocyte globulin was used as induction immunosuppression.
CONCLUSIONS


In this first double-blind randomized trial, islet transplantation data obtained with reparixin do not support a role of CXCR1/2 inhibition in preventing islet inflammation-mediated damage.",2020,There was no statistically significant difference between treatment groups at any time point for any secondary variable.,"['allo-transplant recipients', 'Type 1 Diabetes', 'recipients of islet allo-transplants randomized (2:1) to']","['Placebo', 'placebo', 'reparixin or placebo', 'antithymocyte globulin']","['Insulin Secretion', 'area under the curve (AUC) for C-peptide during the mixed-meal tolerance test', 'C-peptide AUC', 'subjects retaining insulin independence', 'insulin independence and standard measures of glycemic control']","[{'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1506748', 'cui_str': 'repertaxin'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.795937,There was no statistically significant difference between treatment groups at any time point for any secondary variable.,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Maffi', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lundgren', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Tufveson', 'Affiliation': 'Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Rafael', 'Affiliation': 'Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'James A M', 'Initials': 'JAM', 'LastName': 'Shaw', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Liew', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Saudek', 'Affiliation': 'Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Witkowski', 'Affiliation': 'Transplantation Institute, University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Golab', 'Affiliation': 'Transplantation Institute, University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bertuzzi', 'Affiliation': ""Ospedale Niguarda Ca' Granda, Milan, Italy.""}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Gustafsson', 'Affiliation': 'University of Gothenburg, Göteborg, Sweden.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Daffonchio', 'Affiliation': 'Research and Development Department, Dompé farmaceutici S.p.A., Milan, Italy.'}, {'ForeName': 'Pier Adelchi', 'Initials': 'PA', 'LastName': 'Ruffini', 'Affiliation': 'Research and Development Department, Dompé farmaceutici S.p.A., Milan, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Piemonti', 'Affiliation': 'San Raffaele Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy piemonti.lorenzo@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1480']
3434,32017413,Effect of a hand massage with a warm hand bath on sleep and relaxation in elderly women with disturbance of sleep: A crossover trial.,"AIM


The purpose of the present study was to clarify the effects of a hand massage with a warm hand bath on sleep, autonomic nervous activity, subjective sleep quality, and relaxation in elderly women with sleep disturbance.
METHODS


A crossover design was used. Participants were assigned to two groups: a structured control first and intervention second condition, or an intervention first and control second condition. The sleep index as assessed by actigraphy, autonomic nervous activity, subjective sleep quality, and relaxation was then recorded.
RESULTS


The mean age of the participants was 77.8 ± 6.8 years (n = 28). According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015). Regarding autonomic nervous activity, heart rate decreased significantly after the intervention (p = .001), but no significant differences were seen in the other indexes. Subjective sleep quality, which was investigated using the middle-age and aged version of the Oguri-Shirakawa-Azumi sleep questionnaire, was significantly higher after the intervention for four out of five factors. Subjective comfort and relaxation were significantly higher after the intervention for all items.
CONCLUSIONS


A hand massage with a warm hand bath in the evening improved sleep efficiency and sleep onset latency in elderly women with sleep disturbance. These results suggest that a hand bath and massage may improve subjective sleep quality and relaxation.",2020,"According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015).","['elderly women with disturbance of sleep', 'The mean age of the participants was 77.8\u2009±\u20096.8\u2009years (n = 28', 'elderly women with sleep disturbance']","['structured control first and intervention second condition, or an intervention first and control second condition', 'hand massage with a warm hand bath']","['sleep efficiency', 'autonomic nervous activity, heart rate', 'subjective sleep quality and relaxation', 'Subjective sleep quality', 'Subjective comfort and relaxation', 'sleep onset latency', 'sleep efficiency and sleep onset latency', 'sleep, autonomic nervous activity, subjective sleep quality, and relaxation', 'sleep index as assessed by actigraphy, autonomic nervous activity, subjective sleep quality, and relaxation']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0424744', 'cui_str': 'Warm hands (finding)'}, {'cui': 'C0150141'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",28.0,0.0249553,"According to the actigraph, the intervention day showed significantly improved sleep efficiency (p = .048) and sleep onset latency (p = .015).","[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kudo', 'Affiliation': 'Department of Basic Nursing, Akita University Graduate School of Health Sciences, Akita, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Basic Nursing, Akita University Graduate School of Health Sciences, Akita, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12327']
3435,1527129,Isolated ulnar shaft fractures. Comparison of treatment by a functional brace and long-arm cast.,"In a prospective study, we randomly allocated 39 patients with isolated fractures of the lower two-thirds of the ulnar shaft to treatment either by a prefabricated functional brace or a long-arm cast. Significantly better wrist function and a higher percentage of satisfied patients were found in the braced group. Thirteen patients returned to employment while still wearing the brace but only one was able to work in a cast.",1992,Significantly better wrist function and a higher percentage of satisfied patients were found in the braced group.,['39 patients with isolated fractures of the lower two-thirds of the ulnar shaft to treatment either by a'],"['functional brace and long-arm cast', 'prefabricated functional brace or a long-arm cast']",['wrist function'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0442044', 'cui_str': 'Ulnar (qualifier value)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0438847', 'cui_str': 'Functional brace (physical object)'}, {'cui': 'C0575519', 'cui_str': 'Long upper limb (finding)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0031843', 'cui_str': 'function'}]",39.0,0.0213628,Significantly better wrist function and a higher percentage of satisfied patients were found in the braced group.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gebuhr', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre University Hospital, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hölmich', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Orsnes', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Soelberg', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Krasheninnikoff', 'Affiliation': ''}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Kjersgaard', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3436,1447241,Cemented versus uncemented femoral components in the ring hip prosthesis.,"A prospective, randomised and independently assessed trial of the Ring UPM total hip replacement showed that the quality of the early result was better if the femoral prosthesis was cemented than if it was not. More patients with cemented prostheses were painfree at four months (58% cemented:42% uncemented) and at one year (63% cemented:50% uncemented), but at two years pain relief was equal in both groups. At two years significantly more patients with cemented prostheses could walk without support (96% cemented:62% uncemented, p = 0.01 to 0.05). There is a need for more similar trials to compare the results of contemporary designs of cemented and uncemented total hip prostheses.",1992,"More patients with cemented prostheses were painfree at four months (58% cemented:42% uncemented) and at one year (63% cemented:50% uncemented), but at two years pain relief was equal in both groups.",[],['Cemented versus uncemented femoral components'],['pain relief'],[],"[{'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.0298018,"More patients with cemented prostheses were painfree at four months (58% cemented:42% uncemented) and at one year (63% cemented:50% uncemented), but at two years pain relief was equal in both groups.","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Godsiff', 'Affiliation': 'Black Notley Hospital, Braintree, Essex, England.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Emery', 'Affiliation': ''}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Heywood-Waddington', 'Affiliation': ''}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Thomas', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3437,31838377,Comparison of three oral selenium compounds in cancer patients: Evaluation of differential pharmacodynamic effects in normal and malignant cells.,"BACKGROUND


Selenium (Se) compounds have demonstrated therapeutic synergism in combination with anticancer treatments whilst reducing normal tissue toxicities in a range of experimental models. While reduction in some toxicities of chemotherapy and radiation has been confirmed in randomised clinical trials, they have not been powered to evaluate improved anticancer efficacy. A lack of data on the clinical potencies of the main nutritionally-relevant forms of Se and the relationship between their pharmacokinetic (PK) profiles and pharmacodynamic (PD) effects in cancer patients has hampered progress to date. The primary objective of this study was to determine the dose and form of Se that can be most safely and effectively used in clinical trials in combination with anti-cancer therapies.
STUDY METHODS


In a phase I randomised double-blinded study, the PD profile of sodium selenite (SS), Se-methylselenocysteine (MSC) and seleno-l-methionine (SLM) were compared in two cohorts of 12 patients, one cohort with chronic lymphocytic leukaemia (CLL) and the other with solid malignancies. All 24 patients were randomised to receive 400 μg of elemental Se as either SS, MSC or SLM, taken orally daily for 8 weeks. PD parameters were assessed before, during and 4 weeks after Se compound exposure in plasma and peripheral blood mononuclear cells (PBMCs).
RESULTS


No significant sustained changes were observed in plasma concentrations of vascular endothelial growth factor-α (VEGF-α), expression of proteins associated with endoplasmic reticulum stress (the unfolded protein response) or in intracellular total glutathione in PBMCs, in either disease cohort or when grouped by Se compound.
CONCLUSIONS


At the 400 μg dose level no substantial changes in PD parameters were noted. Extrapolating from pre-clinical data, the dose examined in this cohort was too low to achieve the Se plasma concentration (≥ 5 μM) expected to elicit significant PD effects. Recruitment of a subsequent cohort at higher doses to exceed this PK threshold is planned.",2020,"No significant sustained changes were observed in plasma concentrations of vascular endothelial growth factor-α (VEGF-α), expression of proteins associated with endoplasmic reticulum stress (the unfolded protein response) or in intracellular total glutathione in PBMCs, in either disease cohort or when grouped by Se compound.
","['cancer patients', 'All 24 patients', 'two cohorts of 12 patients, one cohort with chronic lymphocytic leukaemia (CLL) and the other with solid malignancies']","['400 μg of elemental Se as either SS, MSC or SLM', 'sodium selenite (SS), Se-methylselenocysteine (MSC) and seleno-l-methionine (SLM']","['normal tissue toxicities', 'anticancer efficacy', 'PD parameters', 'plasma concentrations of vascular endothelial growth factor-α (VEGF-α), expression of proteins associated with endoplasmic reticulum stress', 'plasma and peripheral blood mononuclear cells (PBMCs', 'pharmacokinetic (PK) profiles and pharmacodynamic (PD) effects']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0142923', 'cui_str': 'Sodium Selenite'}, {'cui': 'C0074299', 'cui_str': 'methyl selenocysteine'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}]","[{'cui': 'C0332441', 'cui_str': 'Normal tissue (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3178870', 'cui_str': 'Endoplasmic Reticulum Stress'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0895515,"No significant sustained changes were observed in plasma concentrations of vascular endothelial growth factor-α (VEGF-α), expression of proteins associated with endoplasmic reticulum stress (the unfolded protein response) or in intracellular total glutathione in PBMCs, in either disease cohort or when grouped by Se compound.
","[{'ForeName': 'Stephen O', 'Initials': 'SO', 'LastName': 'Evans', 'Affiliation': 'Department of Biological Sciences, University of Waikato, Hamilton, New Zealand; Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand. Electronic address: Stephen.evans@waikatodhb.health.nz.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Jacobson', 'Affiliation': 'Department of Biological Sciences, University of Waikato, Hamilton, New Zealand. Electronic address: greg.jacobson@waikato.ac.nz.'}, {'ForeName': 'Hugh J B', 'Initials': 'HJB', 'LastName': 'Goodman', 'Affiliation': 'Oncology Department, Waikato Hospital, Hamilton, New Zealand. Electronic address: hugh.goodman@waikatodhb.health.nz.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bird', 'Affiliation': 'Department of Biological Sciences, University of Waikato, Hamilton, New Zealand. Electronic address: sbird@waikato.ac.nz.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Jameson', 'Affiliation': 'Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand; Oncology Department, Waikato Hospital, Hamilton, New Zealand. Electronic address: michael.jameson@waikatodhb.health.nz.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2019.126446']
3438,1544953,"The Sheffield splint for controlled early mobilisation after rupture of the calcaneal tendon. A prospective, randomised comparison with plaster treatment.","Forty patients with acute complete rupture of the calcaneal tendon were managed conservatively and randomly allocated to treatment groups using either cast immobilisation for eight weeks, or cast immobilisation for three weeks, followed by controlled early mobilisation in a Sheffield splint. The splint is an ankle-foot orthosis which holds the ankle in 15 degrees of plantar flexion, but allows some movement at the metatarsophalangeal joints. It is removed to allow controlled movement during physiotherapy. Patients treated with the splint regained mobility significantly more quickly (p less than 0.001) and preferred the splint to the plaster cast. The range of dorsiflexion at the ankle improved more rapidly after treatment in the splint (p less than 0.001), and patients were able to return to normal activities sooner. Recovery of the power of plantar flexion was similar in the two treatment groups, and no patient had excessive lengthening of the tendon. One re-rupture occurred in each group.",1992,Patients treated with the splint regained mobility significantly more quickly (p less than 0.001) and preferred the splint to the plaster cast.,['Forty patients with acute complete rupture of the calcaneal tendon'],"['Sheffield splint', 'cast immobilisation']","['Recovery of the power of plantar flexion', 'excessive lengthening of the tendon', 'range of dorsiflexion at the ankle improved more rapidly']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443186', 'cui_str': 'Complete rupture (morphologic abnormality)'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}]","[{'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",40.0,0.0382322,Patients treated with the splint regained mobility significantly more quickly (p less than 0.001) and preferred the splint to the plaster cast.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': 'Northern General Hospital, Sheffield, England.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacFarlane', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3439,1544959,Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty. A prospective randomised study.,"We studied the effect of a layer of cement placed under the tibial component of Freeman-Samuelson total knee prostheses with a metal back and an 80 mm intramedullary stem, using roentgen stereophotogrammetry to measure the migration of the tibial component during one year in 13 uncemented and 16 cemented knees. The addition of cement produced a significant reduction in migration at one year, from a mean of 1.5 mm to one of 0.5 mm (p less than 0.01), including a significant reduction in pure subsidence. One year postoperatively the clinical results were similar between the groups, but, at three years, one uncemented knee had required revision.",1992,"One year postoperatively the clinical results were similar between the groups, but, at three years, one uncemented knee had required revision.",['13 uncemented and 16 cemented knees'],"['Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty', 'cement placed under the tibial component of Freeman-Samuelson total knee prostheses with a metal back and an 80 mm intramedullary stem, using roentgen stereophotogrammetry']",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022748', 'cui_str': 'Knee Prosthesis'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C3178874', 'cui_str': 'Radiostereometry'}]",[],,0.0330552,"One year postoperatively the clinical results were similar between the groups, but, at three years, one uncemented knee had required revision.","[{'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Albrektsson', 'Affiliation': 'Department of Orthopaedics, Ostra Hospital, Gothenburg, Sweden.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Carlsson', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Freeman', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herberts', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ryd', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3440,1527127,Intra-articular morphine for pain relief after knee arthroscopy.,We performed a randomised double-blind controlled study in patients undergoing elective knee arthroscopy to assess the effect of intra-articular morphine on postoperative pain relief. Patients in the study group (n = 10) received 5 mg of morphine in a 25 ml dilution intra-articularly while those in the control group (n = 10) received 25 ml of saline. Postoperative pain was assessed at intervals by a visual analogue scale and the requirement for supplementary analgesia was recorded. Those in the study group had significantly lower pain scores and required less systemic analgesics than those in the control group. Plasma profiles for morphine and its metabolites were assayed and showed that they were too low to produce effective analgesia. Evidence suggests that analgesia was mediated by local action within the joint.,1992,Those in the study group had significantly lower pain scores and required less systemic analgesics than those in the control group.,"['patients undergoing elective knee arthroscopy', 'pain relief after knee arthroscopy']","['25 ml of saline', 'intra-articular morphine', 'Intra-articular morphine', 'morphine']","['Postoperative pain', 'pain scores', 'postoperative pain relief', 'systemic analgesics', 'Plasma profiles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.256289,Those in the study group had significantly lower pain scores and required less systemic analgesics than those in the control group.,"[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Joshi', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Cappagh Orthopaedic Hospital, Dublin, Republic of Ireland.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'McCarroll', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Cooney', 'Affiliation': ''}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Blunnie', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Lawrence', 'Affiliation': ''}]",The Journal of bone and joint surgery. British volume,[]
3441,32009091,Lenalidomide Treatment for Thalidomide-refractory POEMS Syndrome: A Prospective Single-arm Clinical Trial.,"Objective A randomized controlled trial has shown the efficacy of thalidomide against polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; however, there are still refractory patients. We studied the effects of lenalidomide, a derivative of thalidomide, on patients refractory to thalidomide. Methods This prospective single-arm trial evaluated the safety and efficacy of lenalidomide plus dexamethasone in refractory or recurrent patients with POEMS syndrome. The regimen was administered as six 28-day cycles with lenalidomide on days 1-21 (15 mg in cycle 1, and 25 mg in cycle 2-6) plus dexamethasone once a week (20 mg). The primary endpoints were the rate of reduction in the serum vascular endothelial growth factor (VEGF) level at 24 weeks and the incidence of adverse events. This trial was registered with ClinicalTrial.gov, NCT02193698. Results Between July 2014 and December 2015, five men were enrolled. All patients had been refractory to thalidomide plus dexamethasone for more than 24 weeks. The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003). The mean serum VEGF level decreased from 2,466±771 pg/mL to 974±340 pg/mL. No serious adverse events were observed, and all patients completed six cycles treatment. Discussion Lenalidomide is a therapeutic option for thalidomide-refractory patients with POEMS syndrome.",2020,The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003).,"['recurrent patients with POEMS syndrome', 'refractory POEMS Syndrome', 'Results Between July 2014 and December 2015, five men were enrolled', 'refractory patients with POEMS syndrome']","['dexamethasone', 'Lenalidomide', 'thalidomide plus dexamethasone', 'lenalidomide plus dexamethasone', 'lenalidomide', 'Thalidomide', 'thalidomide']","['serious adverse events', 'incidence of adverse events', 'mean rate of reduction in the serum VEGF level', 'safety and efficacy', 'mean serum VEGF level', 'rate of reduction in the serum vascular endothelial growth factor (VEGF) level']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085404', 'cui_str': 'Crow-Fukase Syndrome'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",5.0,0.185052,The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003).,"[{'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Suichi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Sonoko', 'Initials': 'S', 'LastName': 'Misawa', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Keio University, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Iwai', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Shibuya', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Amino', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Yo-Ichi', 'Initials': 'YI', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Tsuneyama', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.3800-19']
3442,31999606,"Essential oil inhaler (AromaStick®) improves heat tolerance in the Hot Immersion Test (HIT). Results from two randomized, controlled experiments.","BACKGROUND


A recent review article on an aromatherapeutic inhaler demonstrated clinical effects on a number of bodily systems, like the cardiovascular system, the respiratory system, the nervous system and the endocrine system.
OBJECTIVE


This paper extends these findings and investigates whether specially designed essential oils inhalers are capable to counter experimentally induced stressful heat sensations.
METHOD


Two prospective, randomized, controlled experiments using the Hot Immersion Test Paradigm (HIT) were conducted to investigate whether deep odor inhalations increase heat tolerance.
RESULTS


In both experiments, the inhaler strongly prolonged pain tolerance and increased blood oxygenation (1 < d < 1.3). In the second experiment, the inhaler also increased heart rate variability (d = 1.3) as a mechanism to cope with heat stress.
CONCLUSION


The ability to resist a stressful thermal stimulus can be exogenously improved by short and deep inhalations of essential scents directly delivered to the olfactory system.",2020,"In both experiments, the inhaler strongly prolonged pain tolerance and increased blood oxygenation",[],"['Hot Immersion Test Paradigm (HIT', 'Essential oil inhaler (AromaStick®']","['heart rate variability', 'heat tolerance', 'pain tolerance', 'blood oxygenation']",[],"[{'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3544386', 'cui_str': 'Thermotolerance'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0005768'}]",,0.027949,"In both experiments, the inhaler strongly prolonged pain tolerance and increased blood oxygenation","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'RECON - Research and Consulting, Unterer Mühlenweg 38B, 79114, Freiburg, Germany. Electronic address: info@recon-freiburg.biz.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2019.102478']
3443,31331617,Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers.,"BACKGROUND


Numerous anecdotal reports suggest that repeated use of very low doses of lysergic acid diethylamide (LSD), known as microdosing, improves mood and cognitive function. These effects are consistent both with the known actions of LSD on serotonin receptors and with limited evidence that higher doses of LSD (100-200 μg) positively bias emotion processing. Yet, the effects of such subthreshold doses of LSD have not been tested in a controlled laboratory setting. As a first step, we examined the effects of single very low doses of LSD (0-26 μg) on mood and behavior in healthy volunteers under double-blind conditions.
METHODS


Healthy young adults (N = 20) attended 4 laboratory sessions during which they received 0 (placebo), 6.5, 13, or 26 μg of LSD in randomized order at 1-week intervals. During expected peak drug effect, they completed mood questionnaires and behavioral tasks assessing emotion processing and cognition. Cardiovascular measures and body temperature were also assessed.
RESULTS


LSD produced dose-related subjective effects across the 3 doses (6.5, 13, and 26 μg). At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content. Other mood measures, cognition, and physiological measures were unaffected.
CONCLUSIONS


Single microdoses of LSD produced orderly dose-related subjective effects in healthy volunteers. These findings indicate that a threshold dose of 13 μg of LSD might be used safely in an investigation of repeated administrations. It remains to be determined whether the drug improves mood or cognition in individuals with symptoms of depression.",2019,"At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content.","['Healthy Human Volunteers', 'individuals with symptoms of depression', 'healthy volunteers', 'Healthy young adults (N\xa0= 20) attended 4', 'healthy volunteers under double-blind conditions']","['lysergic acid diethylamide (LSD', 'LSD', 'Lysergic Acid Diethylamide', 'laboratory sessions during which they received 0 (placebo']","['Cardiovascular measures and body temperature', 'mood questionnaires and behavioral tasks assessing emotion processing and cognition', 'positivity ratings']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.154263,"At the highest dose, the drug also increased ratings of vigor and slightly decreased positivity ratings of images with positive emotional content.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois; Interdisciplinary Scientist Training Program, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Schepers', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bremmer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Royce', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois. Electronic address: hdew@uchicago.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.05.019']
3444,31504412,Maximum-fixed energy shocks for cardioverting atrial fibrillation.,"AIMS


Direct-current cardioversion is one of the most commonly performed procedures in cardiology. Low-escalating energy shocks are common practice but the optimal energy selection is unknown. We compared maximum-fixed and low-escalating energy shocks for cardioverting atrial fibrillation.
METHODS AND RESULTS


In a single-centre, single-blinded, randomized trial, we allocated elective atrial fibrillation patients to cardioversion using maximum-fixed (360-360-360 J) or low-escalating (125-150-200 J) biphasic truncated exponential shocks. The primary endpoint was sinus rhythm 1 min after cardioversion. Safety endpoints were any arrhythmia, myocardial injury, skin burns, and patient-reported pain after cardioversion. We randomized 276 patients, and baseline characteristics were well-balanced between groups (mean ± standard deviation age: 68 ± 9 years, male: 72%, atrial fibrillation duration >1 year: 30%). Sinus rhythm 1 min after cardioversion was achieved in 114 of 129 patients (88%) in the maximum-fixed energy group, and in 97 of 147 patients (66%) in the low-escalating energy group (between-group difference; 22 percentage points, 95% confidence interval 13-32, P < 0.001). Sinus rhythm after first shock occurred in 97 of 129 patients (75%) in the maximum-fixed energy group compared to 50 of 147 patients (34%) in the low-escalating energy group (between-group difference; 41 percentage points, 95% confidence interval 30-51). There was no significant difference between groups in any safety endpoint.
CONCLUSION


Maximum-fixed energy shocks were more effective compared with low-escalating energy shocks for cardioverting atrial fibrillation. We found no difference in any safety endpoint.",2020,"There was no significant difference between groups in any safety endpoint.
","['cardioverting atrial fibrillation', '276 patients, and baseline characteristics were well-balanced between groups (mean ± standard deviation age: 68\u2009±\u20099\u2009years, male: 72%, atrial fibrillation duration >1 year: 30']","['Maximum-fixed energy shocks', 'elective atrial fibrillation patients to cardioversion using maximum-fixed (360-360-360\u2009J) or low-escalating (125-150-200\u2009J) biphasic truncated exponential shocks', 'maximum-fixed and low-escalating energy shocks']","['Sinus rhythm after first shock', 'arrhythmia, myocardial injury, skin burns, and patient-reported pain after cardioversion', 'sinus rhythm 1 min after cardioversion', 'safety endpoint']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4280965', 'cui_str': '>1'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}]","[{'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",276.0,0.322205,"There was no significant difference between groups in any safety endpoint.
","[{'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}, {'ForeName': 'Kasper G', 'Initials': 'KG', 'LastName': 'Lauridsen', 'Affiliation': 'Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Torp', 'Affiliation': 'Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}, {'ForeName': 'Leif F', 'Initials': 'LF', 'LastName': 'Bach', 'Affiliation': 'Department of Anesthesiology, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Rickers', 'Affiliation': 'Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Løfgren', 'Affiliation': 'Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers NE, Denmark.'}]",European heart journal,['10.1093/eurheartj/ehz585']
3445,32012217,Percutaneous Cordotomy for Pain Palliation in Advanced Cancer: A Randomized Clinical Trial Study Protocol.,"BACKGROUND


Cancer pain, one of the most common symptoms for patients with advanced cancer, is often refractory to maximal medical therapy. A controlled clinical trial is needed to provide definitive evidence to support the use of ablative procedures such as cordotomy for patients with medically refractory cancer pain.
OBJECTIVE


To assess the efficacy of cordotomy for patients with unilateral advanced cancer pain using a controlled clinical trial study design. The secondary objectives are to define the patient experience of cordotomy for medically refractory cancer pain as well as to determine the utility of magnetic resonance imaging as a non-invasive biomarker for successful cordotomy.
METHODS


We will undertake a single-institution, double-blind, sham-controlled clinical trial of cordotomy in patients with refractory cancer pain. Patients in the cordotomy arm will undergo a percutaneous computed tomography-guided cordotomy at C1-C2, while patients in the control arm will undergo a similar procedure where the needle will not penetrate the thecal sac. The primary endpoint will be the reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale.
EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
DISCUSSION


This randomized clinical trial comparing cordotomy with a control intervention will provide the level of evidence necessary to determine whether cordotomy should be the standard of care intervention for patients with advanced cancer pain.",2020,"EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
","['patients with advanced cancer', 'patients with medically refractory cancer pain', 'Advanced Cancer', 'patients with advanced cancer pain', 'patients with unilateral advanced cancer pain', 'patients with refractory cancer pain']","['Percutaneous Cordotomy', 'cordotomy', 'control intervention', 'percutaneous computed tomography-guided cordotomy at C1-C2']","['reduction in pain intensity, as measured by the Edmonton Symptoms Assessment Scale', 'pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0196243', 'cui_str': 'Spinal percutaneous cordotomy (procedure)'}, {'cui': 'C0010009', 'cui_str': 'Cordotomy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}]",,0.191581,"EXPECTED OUTCOMES


We expect that patients randomized to cordotomy will have a significantly greater reduction in pain intensity than those patients randomized to the control surgical intervention.
","[{'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Vedantam', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Loretta A', 'Initials': 'LA', 'LastName': 'Williams', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Dhanalakshmi', 'Initials': 'D', 'LastName': 'Koyyalagunta', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Salahadin', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Mendoza', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Roland L', 'Initials': 'RL', 'LastName': 'Bassett', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Hou', 'Affiliation': 'Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Neurosurgery,['10.1093/neuros/nyz527']
3446,31807849,Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial.,"PURPOSE


Drug-eluting stents (DES) improve clinical and morphological long-term results compared to percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS) in patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial). We performed a cost-effectiveness analysis of DES compared to PTA ± BMS in cooperation with Dutch health insurance company VGZ, using data from the PADI trial.
MATERIALS AND METHODS


In the PADI trial, adults with CLI (Rutherford category ≥ 4) and infrapopliteal lesions were randomized to receive DES with paclitaxel or PTA ± BMS. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA ± BMS. The costs were calculated by using the mean costs per stent multiplied by the mean number of stents used per patient (€750 × 1.8 for DES vs €250 × 0.3 for PTA ± BMS). These costs were compared with the costs of major amputation (€16.000) and rehabilitation (first year €15.750, second year €7.375 and third year €3.600).
RESULTS


The 5-year major amputation rate was lower in the DES group (19.3% vs 34.0% for PTA ± BMS; p = 0.091). In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1 year, the cost difference per patient between DES and PTA ± BMS is €1.679 in favor of DES and €2.694 after 3 years.
CONCLUSION


In our analysis, DES are cost-effective due to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS group.
LEVEL OF EVIDENCE


Level 1b, analysis based on clinically sensible costs and randomized controlled trial.",2020,"In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively).","['Patients with Critical Limb Ischemia', 'patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial', 'adults with CLI (Rutherford category ≥\xa04) and infrapopliteal lesions', 'Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA\xa0±\xa0BMS']","['DES with paclitaxel', 'Drug-Eluting Stents', 'percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS', 'Drug-eluting stents (DES', 'DES']","['5-year major amputation rate', '5-year amputation-free survival and event-free survival', 'Cost-Effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0336968', 'cui_str': 'Sky-diving (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.120156,"In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively).","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Wakkie', 'Affiliation': 'Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands. twakkie@gmail.com.'}, {'ForeName': 'Louise C D', 'Initials': 'LCD', 'LastName': 'Konijn', 'Affiliation': 'Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands.'}, {'ForeName': 'Nils P C', 'Initials': 'NPC', 'LastName': 'van Herpen', 'Affiliation': 'VGZ Health Insurance, Nijmegen, The Netherlands.'}, {'ForeName': 'Martijn F H', 'Initials': 'MFH', 'LastName': 'Maessen', 'Affiliation': 'VGZ Health Insurance, Nijmegen, The Netherlands.'}, {'ForeName': 'Marlon I', 'Initials': 'MI', 'LastName': 'Spreen', 'Affiliation': 'Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Wever', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Randolph G', 'Initials': 'RG', 'LastName': 'Statius van Eps', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Hugo T', 'Initials': 'HT', 'LastName': 'Veger', 'Affiliation': 'Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Lukas C', 'Initials': 'LC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands.'}, {'ForeName': 'Willem P Th M', 'Initials': 'WPTM', 'LastName': 'Mali', 'Affiliation': 'Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Overhagen', 'Affiliation': 'Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands. h.voverhagen@hagaziekenhuis.nl.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-019-02385-5']
3447,1018027,"A five-year assessment of controlled trials of in-patient and out-patient treatment and of plaster-of-Paris jackets for tuberculosis of the spine in children on standard chemotherapy. Studies in Masan and Pusan, Korea. Fifth report of the Medical Research Council Working Party on tuberculosis of the spine.","In two centres in Korea 350 patients with a diagnosis of tuberculosis of the thoracic and/or lumbar spine were allocated at random: in Masan to in-patient rest in bed (IP) for six months followed by out-patient treatment or to ambulatory out-patient treatment (OP) from the start; in Pusan to out-patient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). All patients recieved chemotherapy with PAS with isoniazid for eighteen months, either supplemented with streptomycin for the first three months (SPH) or without this supplement (PH), by random allocation. The main analysis of this report concerns 299 patients (eighty-three IP, eighty-three OP, sixty-three J, seventy No J; 143 SPH, 156 PH). Pre-treatment factors were similar in both centres except that the patients in Pusan had, on average, less extensive lesions although in a greater proportion the disease was radiographically active. One patient (J/SPH) died with active spinal disease and three (all No J/SPH) with paraplegia. A fifth patient (IP/PH) who died from cardio respiratory failure also had pulmonary tuberculosis. Twenty-three patients required operation and/or additional chemotherapy for the spinal lesion. A sinus or clinically evident abscess was either present initially or developed during treatment in 41 per cent of patients. Residual lesions persisted in ten patients (four IP, two OP, one J, three No J; six SPH, four PH) at five years. Thirty-two patients had paraparesis on admission or developing later. Complete resolution occurred in twenty on the allocated regimen and in eight after operation or additional chemotherapy or both. Of the remaining four atients, all of whom had operation and additional chemotherapy, three died and one still had paraparesis at five years. Of 295 patients assessed at five years 89 per cent had a favourable status. The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.",1976,"The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.","['In two centres in Korea 350 patients with a diagnosis of tuberculosis of the thoracic and/or lumbar spine', 'Thirty-two patients had paraparesis on admission or developing later', 'Twenty-three patients required operation and/or additional chemotherapy for the spinal lesion', '299 patients (eighty-three IP, eighty-three OP, sixty-three J, seventy No J; 143 SPH, 156 PH', 'Of 295 patients assessed at five years 89 per cent had a favourable status', 'children on standard chemotherapy']","['chemotherapy with PAS with isoniazid', 'streptomycin for the first three months (SPH) or without this supplement (PH', 'plaster-of-Paris jackets', 'random: in Masan to in-patient rest in bed (IP) for six months followed by out-patient treatment or to ambulatory out-patient treatment (OP) from the start; in Pusan to out-patient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J']","['Residual lesions', 'Complete resolution']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0221166', 'cui_str': 'Paraparesis'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0032160', 'cui_str': 'Plaster of Paris'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0044434', 'cui_str': 'sulphimidazole'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0453944', 'cui_str': 'Jacket (physical object)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",350.0,0.0379119,"The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.",[],The Journal of bone and joint surgery. British volume,[]
3448,31914242,"Health Care Hotspotting - A Randomized, Controlled Trial.","BACKGROUND


There is widespread interest in programs aiming to reduce spending and improve health care quality among ""superutilizers,"" patients with very high use of health care services. The ""hotspotting"" program created by the Camden Coalition of Healthcare Providers (hereafter, the Coalition) has received national attention as a promising superutilizer intervention and has been expanded to cities around the country. In the months after hospital discharge, a team of nurses, social workers, and community health workers visits enrolled patients to coordinate outpatient care and link them with social services.
METHODS


We randomly assigned 800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care. The primary outcome was hospital readmission within 180 days after discharge.
RESULTS


The 180-day readmission rate was 62.3% in the intervention group and 61.7% in the control group. The adjusted between-group difference was not significant (0.82 percentage points; 95% confidence interval, -5.97 to 7.61). In contrast, a comparison of the intervention-group admissions during the 6 months before and after enrollment misleadingly suggested a 38-percentage-point decline in admissions related to the intervention because the comparison did not account for the similar decline in the control group.
CONCLUSIONS


In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care. (Funded by the National Institute on Aging and others; ClinicalTrials.gov number, NCT02090426; American Economic Association registry number, AEARCTR-0000329.).",2020,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","['patients with very high use of health care services', 'community health workers visits enrolled patients to coordinate outpatient care and link them with social services', ""800 hospitalized patients with medically and socially complex conditions, all with at least one additional hospitalization in the preceding 6 months, to the Coalition's care-transition program or to usual care"", 'superutilizers,"" patients with very high use of health care services']","[""Coalition's program than among those who received usual care""]","['hospital readmission within 180 days after discharge', 'readmission rates', '180-day readmission rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",800.0,0.0828356,"In this randomized, controlled trial involving patients with very high use of health care services, readmission rates were not lower among patients randomly assigned to the Coalition's program than among those who received usual care.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Annetta', 'Initials': 'A', 'LastName': 'Zhou', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taubman', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'From the Massachusetts Institute of Technology (A.F., J.D.) and the National Bureau of Economic Research (A.Z., S.T.) - both in Cambridge.'}]",The New England journal of medicine,['10.1056/NEJMsa1906848']
3449,30325677,Guided graded Exercise Self-help for chronic fatigue syndrome: patient experiences and perceptions.,"Purpose : This study explored patient experiences of Guided graded Exercise Self-help (GES) delivered as part of a randomised controlled trial for people with chronic fatigue syndrome/myalgic encephalomyelitis. The trial found that GES was better than specialist medical care at reducing fatigue and improving physical functioning. Methods : Semi-structured interviews were conducted with patients reporting improvement ( n  = 9) and deterioration ( n  = 10), and analysis involved thematic ""constant comparison."" Results : The improved group described more facilitators to doing GES, and were more likely to describe high levels of self-motivation, whereas the deteriorated group described more barriers to GES (including worse exacerbation of symptoms after GES, greater interference from comorbid conditions, and obstacles to GES in their lives), and had been ill for longer. Having the capacity to do GES was important; of note, those with relatively lower levels of functioning sometimes had more time and space in their lives to support their GES engagement. We identified an important ""indeterminate phase"" early on, in which participants did not initially improve. Conclusions : GES may be improved by targeting those most likely to improve, and teaching about the indeterminate phase.Implications for rehabilitationUsing the Guided Exercise Self-help booklet alone is unlikely to be sufficient to support patients through Guided Exercise Self-help successfully.Additional guidance from skilled physiotherapists/health professionals who demonstrate an understanding of what it is like to cope with chronic fatigue syndrome/myalgic encephalomyelitis is also important.Those using Guided Exercise Self-help may need additional support through a commonly experienced ""indeterminate phase"" - an initial phase in the programme where few benefits, along with various challenges associated with increasing activity, are experienced.Individuals who have been ill with chronic fatigue syndrome/myalgic encephalomyelitis for a relatively longer period of time and/or have additional comorbid conditions may benefit from more bespoke therapies with greater health professionals input, delivered by appropriate therapists.",2020,"The improved group described more facilitators to doing GES, and were more likely to describe high levels of self-motivation, whereas the deteriorated group described more barriers to GES (including worse exacerbation of symptoms after GES, greater interference from comorbid conditions, and obstacles to GES in their lives), and had been ill for longer.","['people with chronic fatigue syndrome/myalgic encephalomyelitis', 'Semi-structured interviews were conducted with patients reporting improvement (n\u2009=\u20099) and deterioration (n\u2009=\u200910), and analysis involved thematic ""constant comparison', 'Individuals who have been ill with chronic fatigue syndrome/myalgic encephalomyelitis']","['Guided graded Exercise Self-help', 'GES', 'Guided graded Exercise Self-help (GES']","['fatigue and improving physical functioning', 'levels of self-motivation']","[{'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0520633,"The improved group described more facilitators to doing GES, and were more likely to describe high levels of self-motivation, whereas the deteriorated group described more barriers to GES (including worse exacerbation of symptoms after GES, greater interference from comorbid conditions, and obstacles to GES in their lives), and had been ill for longer.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cheshire', 'Affiliation': 'College of Arts and Liberal Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Ridge', 'Affiliation': 'College of Arts and Liberal Sciences, University of Westminster, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': ""Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Bart's and the London School of Medicine and Dentistry, Queen Mary University, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Bart's and the London School of Medicine and Dentistry, Queen Mary University, London, UK.""}]",Disability and rehabilitation,['10.1080/09638288.2018.1499822']
3450,31544925,Nurse-led vs. usual-care for atrial fibrillation.,"BACKGROUND


Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist.
METHODS AND RESULTS


We randomized 1375 patients with atrial fibrillation (64 ± 10 years, 44% women, 57% had CHA2DS2-VASc ≥ 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37 months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P = 0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interaction <0.001).
CONCLUSION


Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037).
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT01740037).",2020,The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care.,"['671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients', 'patients with atrial fibrillation', '1375 patients with atrial fibrillation (64\u2009±\u200910 years, 44% women, 57% had CHA2DS2-VASc\u2009≥\u20092) to receive nurse-led care or usual-care']",[],"['usual-care [hazard ratio (HR', 'arrhythmia events', 'cumulative adherence', 'composite of cardiovascular death and cardiovascular hospital admissions', 'heart failure']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",1375.0,0.194953,The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care.,"[{'ForeName': 'E P J Petra', 'Initials': 'EPJP', 'LastName': 'Wijtvliet', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Department of Cardiology, Martini Hospital, Van Swietenplein 1, 9728 NT Groningen, The Netherlands.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'van Gelder', 'Affiliation': 'Department of Cardiology, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Nikki A H A', 'Initials': 'NAHA', 'LastName': 'Pluymaekers', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'Department of Cardiology, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Folkeringa', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, Henri Dunantweg 2, 8934 AD Leeuwarden, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bronzwaer', 'Affiliation': 'Department of Cardiology, Zaans Medical Centre, Kon. Julianaplein 58, 1502 DV Zaandam, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB Zwolle, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Elders', 'Affiliation': 'Department of Cardiology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, The Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tukkie', 'Affiliation': 'Department of Cardiology, Spaarne Hospital, Haarlem, The Netherlands.'}, {'ForeName': 'Justin G L M', 'Initials': 'JGLM', 'LastName': 'Luermans', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'A D I Thea', 'Initials': 'ADIT', 'LastName': 'Van Asselt', 'Affiliation': 'Department of Epidemiology, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'Van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology, Medical Technology Assessment, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam University Medical Centre, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz666']
3451,31959047,Restitution of gut microbiota in Ugandan children administered with probiotics ( Lactobacillus rhamnosus  GG and  Bifidobacterium animalis  subsp.  lactis  BB-12) during treatment for severe acute malnutrition.,"Severe acute malnutrition (SAM) is a major challenge in low-income countries and gut microbiota (GM) dysbiosis may play a role in its etiology. Here, we determined the GM evolution during rehabilitation from SAM and the impact of probiotics ( Lactobacillus rhamnosus  GG and  Bifidobacterium animalis  subsp. lactis BB-12) supplementation. The GM (16S rRNA gene amplicon sequencing) of children admitted to hospital with SAM showed distinct composition over admission (e.g.  Klebsiella  spp., and Enterobacteriaceae spp.), discharge (e.g. Clostridiaceae spp.,  Veilonella dispar ) and follow-up (e.g.  Lactobacillus ruminis, Blautia  spp.,  Faecalibacterium prausnitzii ), reaching similar β- and α-diversity as healthy individuals. Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity. Children suffering from edematous SAM had diminished proportion of Prevotellaceae, Lachnospiraceae, Ruminoccaceae and a higher α-diversity when compared to non-edematous SAM. Supplementation of probiotics did not influence β-diversity upon discharge or follow-up, but it increased ( p  < .05) the number of observed species [SE: > 4.5]. Children where the probiotic species were detected had lower cumulative incidence ( p  < .001) of diarrhea during the follow-up period compared to children receiving placebo and children receiving probiotics, but where the probiotics were not detected. The GM of children with non-edematous and edematous SAM differ in composition, which might have implications for future GM targeted treatments. Probiotics treatment reduced the cumulative incidence of diarrhea during the outpatient phase, with the strongest effect in children where the administered probiotics could be detected in the GM.",2020,"Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity.","['Severe acute malnutrition (SAM', 'Ugandan children', 'children admitted to hospital with SAM', 'severe acute malnutrition']","['Probiotics', 'placebo', 'probiotics ( Lactobacillus rhamnosus  GG', 'lactis  BB-12']","['diarrhea', 'Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity', 'cumulative incidence of diarrhea', 'cumulative incidence', 'proportion of Prevotellaceae, Lachnospiraceae, Ruminoccaceae and a higher α-diversity']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004660', 'cui_str': 'Bacteroidaceae'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0995357', 'cui_str': 'Moraxellaceae'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0345175,"Children with diarrhea had reduced distribution of Bacteroidaceae, Lachnospiraceae, increased Enterobacteriaceae and Moraxellaceae, and lower α-diversity.","[{'ForeName': 'Josué L', 'Initials': 'JL', 'LastName': 'Castro-Mejía', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': ""O'Ferrall"", 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krych', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Hanifa', 'Initials': 'H', 'LastName': 'Namusoke', 'Affiliation': 'Mwanamugimu Nutrition Unit, Department of Paediatrics and Child Health, Mulago National Referral Hospital , Kampala, Uganda.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Lanyero', 'Affiliation': 'Mwanamugimu Nutrition Unit, Department of Paediatrics and Child Health, Mulago National Referral Hospital , Kampala, Uganda.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Kot', 'Affiliation': 'Department of Plant and Environmental Sciences, University of Copenhagen , Frederiksberg C, Denmark.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Nabukeera-Barungi', 'Affiliation': 'Department of Paediatrics and Child Health, College of Health Sciences, Makerere University , Kampala, Uganda.'}, {'ForeName': 'Kim Fleischer', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen , Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Food Science, University of Copenhagen , Frederiksberg C, Denmark.'}]",Gut microbes,['10.1080/19490976.2020.1712982']
3452,31986515,A Phase II Trial of Everolimus in Patients with Advanced Pancreatic Neuroendocrine Carcinoma Refractory or Intolerant to Platinum-Containing Chemotherapy (NECTOR Trial).,"BACKGROUND


Platinum-containing regimens are widely used as first-line chemotherapy for unresectable pancreatic neuroendocrine carcinoma (NEC), but second-line chemotherapies have yet to be established.
OBJECTIVES


We evaluated the safety and efficacy of everolimus in patients with pancreatic NEC refractory or intolerant to platinum-containing chemotherapy.
METHODS


This study was a prospective, multicenter, phase II trial in patients with pancreatic NEC after platinum-containing chemotherapy. Everolimus treatment was continued until disease progression or intolerable toxicity was observed. The primary endpoint was progression-free survival (PFS).
RESULTS


Participants comprised 25 patients. Median age was 63 years, median PFS was 1.2 months (95% confidence interval [CI] 0.9-3.1 months), median overall survival was 7.5 months (95% CI 3.1-13.5 months), overall response rate was 0%, and disease control rate was 39.1%. Common grade 3/4 adverse events were hyperglycemia (20%), thrombocytopenia (16%), and anemia (16%).
CONCLUSION


The efficacy of everolimus was limited in patients with unresectable pancreatic NEC.",2020,", median overall survival was 7.5 months (95%CI 3.1- 13.5 months), overall response rate was 0%, and disease control rate was 39.1%.","['patients with pancreatic NEC refractory or intolerant to platinum-containing chemotherapy', 'Median age was 63 years, median PFS was 1.2 months', 'patients with advanced pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-containing chemotherapy (NECTOR trial', 'patients with unresectable pancreatic NEC', 'patients with pancreatic NEC after platinum-containing chemotherapy', 'Participants comprised 25 patients']","['everolimus', 'Everolimus']","['median overall survival', 'overall response rate', 'intolerable toxicity', 'progression-free survival (PFS', 'disease control rate', 'thrombocytopenia', 'safety and efficacy', 'anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0206695', 'cui_str': 'Carcinoma, Neuroendocrine'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",,0.0498578,", median overall survival was 7.5 months (95%CI 3.1- 13.5 months), overall response rate was 0%, and disease control rate was 39.1%.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuyama', 'Affiliation': 'Department of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan, masikeda@east.ncc.go.jp.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Ohkawa', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Oncology, Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine University of Toyama, Toyama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Gastroenterology, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Gou', 'Initials': 'G', 'LastName': 'Murohisa', 'Affiliation': 'Department of Gastroenterology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Shioji', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Asagi', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}]",Neuroendocrinology,['10.1159/000505550']
3453,350883,"Five-year assessments of controlled trials of ambulatory treatment, debridement and anterior spinal fusion in the management of tuberculosis of the spine. Studies in Bulawayo (Rhodesia) and in Hong Kong. Sixth report of the Medical Research Council Working Party on Tuberculosis of the Spine.",,1978,,['tuberculosis of the spine'],"['ambulatory treatment, debridement and anterior spinal fusion']",[],"[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0037935', 'cui_str': 'Spinal Fusion'}]",[],,0.0400683,,[],The Journal of bone and joint surgery. British volume,[]
3454,31995222,Comparative Effect of Mother's Hug and Massage on Neonatal Pain Behaviors Caused by Blood Sampling: A Randomized Clinical Trial.,"BACKGROUND


The early experience of pain can lead to complications such as tachycardia, tachypnea and increased metabolic needs of the body, thereby exacerbation of the behavioral and physiological responses to pain in neonates. The current study aimed to compare the effect of a mother's hug and massage on pain behaviors during and after blood sampling in neonates.
METHOD


This study was a randomized clinical trial. A total of 135 healthy full-term neonates were selected by convenience sampling method. Samples were randomly assigned to a mother's hug group, massage group or control group. In all three groups, the behavioral responses of the neonate were measured and recorded before, immediately and 5 min after blood sampling by Neonatal Infant Pain Scale. Heart rate, respiratory rate and blood oxygen saturation were recorded with pulse oximetry, and the crying period was measured from start to silence using a stopwatch.
RESULTS


The results showed that after 5 min, the pain and heart rate in the mother's hug group decreased significantly compared to the massage and control groups (p < 0.001). There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05). The duration of crying in the mother's hug group had more reduction than that of the massage and control groups (p < 0.001).
CONCLUSION


The placement of the baby in the mother's hug during painful procedures is recommended due to the reduction of pain, the improvement of physiological symptoms and the promotion of neonatal health.",2020,There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05).,"['135 healthy full-term neonates', 'neonates']","[""mother's hug and massage"", 'Blood Sampling', ""Mother's Hug and Massage"", ""mother's hug group, massage group or control group""]","['Heart rate, respiratory rate and blood oxygen saturation', 'duration of crying', 'pain behaviors', 'pain and heart rate', 'respiratory rate and blood oxygen saturation level', 'behavioral responses of the neonate', 'Neonatal Pain Behaviors']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",135.0,0.0406076,There were no significant changes in the respiratory rate and blood oxygen saturation level in any of the newborns during blood sampling (p > 0.05).,"[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Roshanray', 'Affiliation': 'Neonatal Intensive Care Nursing, Pediatric Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rayyani', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Critical Care Department, Nursing School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Aref', 'Initials': 'A', 'LastName': 'Faghih', 'Affiliation': 'Social Determination in Health Promotion Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa001']
3455,30466040,Randomized controlled trial of telephone monitoring with psychiatry inpatients with co-occurring substance use and mental health disorders.,"Background Psychiatry inpatients frequently have co-occurring substance use and mental health disorders, which are related to poor post-discharge outcomes. Telephone monitoring is effective in specialty substance use disorder treatment settings in increasing continuing care and 12-step program utilization and improving substance use outcomes. This study examined the effectiveness of telephone monitoring among psychiatry inpatients with co-occurring substance use and mental health disorders. Methods This randomized controlled trial (n = 406) compared usual care to usual care plus telephone monitoring (one in-person session during the inpatient stay, followed by weekly telephone contact for three months post-discharge). Follow-ups were conducted at end-of-intervention (three months post-baseline) and nine and 15 months post-baseline (73% followed). Primary outcomes were number of days out of the past 30 of drinking alcohol, using drugs, and experiencing psychological problems. Secondary outcomes were outpatient substance use treatment, and 12-step group, utilization. Results Longitudinal modeling found that patients in both conditions improved over time on each primary outcome. Improvement was comparable between conditions on alcohol and drug use and psychological problems. Receipt of outpatient treatment decreased over the follow-up period and was not related to condition. Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition. Conclusions Improvement over time was evident regardless of condition assignment. Patients maintained attendance at 12-step groups from pre- to post-discharge. Short-term telephone monitoring in addition to usual care for patients with co-occurring substance use and mental health disorders may not be sufficiently intensive to achieve additional improvements on outcomes.",2019,"Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition.","['psychiatry inpatients with co-occurring substance use and mental health disorders', 'patients with co-occurring substance use and mental health disorders', ' Psychiatry inpatients frequently have co-occurring substance use and mental health disorders']","['telephone monitoring', 'usual care to usual care plus telephone monitoring (one in-person session', 'Telephone monitoring', 'telephone']","['outpatient substance use treatment, and 12-step group, utilization', 'number of days out of the past 30 of drinking alcohol, using drugs, and experiencing psychological problems']","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0531996,"Likelihood of attending 12-step group meetings did not change over follow-ups, and was not related to condition.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Timko', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305, USA. Electronic address: ctimko@stanford.edu.'}, {'ForeName': 'Alex H S', 'Initials': 'AHS', 'LastName': 'Harris', 'Affiliation': 'Center for Innovation to Implementation, Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, USA; Department of Surgery, Stanford University School of Medicine, Stanford, CA, 94305, USA. Electronic address: Alexander.Harris2@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jannausch', 'Affiliation': 'Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI, 48109, USA. Electronic address: mjann@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ilgen', 'Affiliation': 'Department of Psychiatry, University of Michigan School of Medicine, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI, 48109, USA. Electronic address: marki@med.umich.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.09.010']
3456,31539628,"Changes in global electrical heterogeneity associated with dofetilide, quinidine, ranolazine, and verapamil.","BACKGROUND


Electrocardiographic (ECG) markers of antiarrhythmic drug (AAD) activity could be used to optimize efficacy and minimize toxicity. Vectorcardiographic global electrical heterogeneity (GEH) is associated with ventricular arrhythmias and sudden death, but it is unclear how GEH measurements change in response to AADs.
OBJECTIVE


The purpose of this study was to characterize acute effects of AADs on GEH measurements.
METHODS


We analyzed double-blind placebo-controlled trial data from healthy volunteers given 1 dose of placebo, dofetilide, quinidine, ranolazine, or verapamil on subsequent visits. Serial ECGs and plasma drug concentrations were collected. Vectorcardiographic GEH parameters (spatial ventricular gradient [SVG], spatial QRST angle, sum absolute QRST integral, and SVG-QRS peak angle) were measured. Placebo-corrected change from baseline was regressed on drug concentration stratified by sex using linear mixed effects models.
RESULTS


Among 22 persons (11 (50%) male median age 27 ± 5 years), 5232 ECGs were analyzed. Dofetilide and quinidine were associated with significant changes in more GEH parameters (5) compared with verapamil (2) and ranolazine (1). The most notable change occurred in SVG azimuth, with largest changes (degrees per unit normalized drug concentration) in dofetilide (6.1; 95% confidence interval [CI] 4.2-8.0) and quinidine (9.4; 95% CI 6.7-12.0), and smaller effects in verapamil (4.4; 95% CI 2.9-5.9) and ranolazine (5.4; 95% CI 3.5-7.3). AAD-induced GEH changes significantly differed in men and women.
CONCLUSION


AADs change GEH measurements. These changes, which differ by sex, are likely driven by alterations in ion channel function and dispersion of depolarization or repolarization. GEH measurement may allow early assessment of favorable or adverse AAD effects.",2020,Dofetilide and quinidine were associated with significant changes in more GEH parameters (5) compared to verapamil (2) and ranolazine (1).,"['22 persons (50% male, age 27±5 years), 5232 ECGs were analyzed', 'men and women', 'healthy volunteers given 1 dose of']","['quinidine', 'Placebo', 'placebo, dofetilide, quinidine, ranolazine, or verapamil', 'verapamil', 'ranolazine', 'placebo', 'Quinidine, Ranolazine, And Verapamil', 'Vectorcardiographic (VCG) global electrical heterogeneity (GEH']","['SVG azimuth', 'GEH changes', 'Serial ECGs and plasma drug levels', 'VCG GEH parameters (spatial ventricular gradient [SVG], spatial QRST angle, sum absolute QRST integral, and SVG-QRS peak angle']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0114771', 'cui_str': 'dofetilide'}, {'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C0199604', 'cui_str': 'Vectorcardiogram (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",22.0,0.320389,Dofetilide and quinidine were associated with significant changes in more GEH parameters (5) compared to verapamil (2) and ranolazine (1).,"[{'ForeName': 'Hans Friedrich', 'Initials': 'HF', 'LastName': 'Stabenau', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Larisa G', 'Initials': 'LG', 'LastName': 'Tereshchenko', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Waks', 'Affiliation': 'Harvard-Thorndike Electrophysiology Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: jwaks@bidmc.harvard.edu.'}]",Heart rhythm,['10.1016/j.hrthm.2019.09.017']
3457,32053942,Supplementation with a Bioactive Melon Concentrate in Humans and Animals: Prevention of Oxidative Damages and Fatigue in the Context of a Moderate or Eccentric Physical Activity.,"Exercise is recognized to provide both physical and psychological health benefits. However, oxidative stress can occur and induce muscular damages. SOD B® M is a melon concentrate, well known to counteract oxidative stress and prevent its side effects. The present study aimed to evaluate the potential of the melon concentrate in the context of both a strong and isolated effort associated with deleterious effects, and a moderate and regular physical activity considered as beneficial. First, a preclinical study was set up on rats to evaluate its potential on the prevention of damages induced by an eccentric exercise. Secondly, the combined effect of the melon concentrate and a regular standardized physical training was studied on the overall physical condition of healthy subjects in a randomized, double-blind, placebo-controlled trial. Repeated measures Analysis of Variance (ANOVA), student's t test and Mann-Whitney test were used for statistical analyses. Melon concentrate helped to prevent gastrocnemius damages induced by the eccentric exercise. It allowed a reduction of fibrosis by approximately 38% and a reduction of Tumor Necrosis Factor- α (TNF-α) plasma level by 28%. This supplementation also induced a rearrangement of myosin fibers and an increase in PGC-1α plasma level. In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level. Besides, magnesium (Mg) plasma level was higher in the context of a regular training performed by healthy subjects supplemented with the melon concentrate. Therefore, the melon concentrate allowed a better adaptation to effort linked to PGC-1α activation: a regulator of energy metabolism. The antioxidant properties of the melon concentrate and its ability to mobilize magnesium also suggest that the supplementation could induce a better resistance to fatigue and recovery during regular physical activity.",2020,"In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level.","['Humans and Animals', 'healthy subjects']","['melon concentrate and a regular standardized physical training', 'placebo', 'α', 'Bioactive Melon Concentrate', 'SOD B®']","['PGC-1α plasma level', 'oxidative stress and C-Reactive protein (CRP) plasma level', 'Tumor Necrosis Factor', 'TNF-α) plasma level', 'magnesium (Mg) plasma level']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0440285', 'cui_str': 'Melons'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]",,0.0486878,"In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Saby', 'Affiliation': 'EA7288 UFR Pharmacie, Université de Montpellier, CEDEX 5, 34093 Montpellier, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': 'Bionov Research, 939 rue de la croix verte, 34090 Montpellier, France.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Barial', 'Affiliation': 'EA7288 UFR Pharmacie, Université de Montpellier, CEDEX 5, 34093 Montpellier, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Egoumenides', 'Affiliation': 'Bionov Research, 939 rue de la croix verte, 34090 Montpellier, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Jover', 'Affiliation': 'PhyMedExp, INSERM CNRS, Université de Montpellier, IURC, CEDEX 5, 34295 Montpellier, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17041142']
3458,31839677,Dual-specificity protein phosphatase DUSP4 regulates response to MEK inhibition in BRAF wild-type melanoma.,"BACKGROUND


Aiming to improve treatment options for BRAF wild-type melanoma, we previously conducted the DOC-MEK study of docetaxel with MEK inhibitor (MEKi) selumetinib or placebo, revealing trends to prolongation of progression-free survival (hazard ratio 0.75, P = 0.130), and improved response rates (32% vs 14%, P = 0.059) with docetaxel plus selumetinib. NRAS status did not associate with outcome. Here, the aim was to identify novel biomarkers of response to MEKi.
METHODS


A MEK 6 gene signature was quantified using NanoString and correlated with clinical outcomes. Two components of the gene signature were investigated by gene silencing in BRAF/NRAS wild-type melanoma cells.
RESULTS


In melanomas of patients on the selumetinib but not the placebo arm, two gene signature components, dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4), were expressed more highly in responders than non-responders. In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib. In contrast, DUSP4-depleted cells showed enhanced cell survival and increased resistance to both selumetinib and trametinib.
CONCLUSIONS


ETV4 and DUSP4 associated with clinical response to docetaxel plus selumetinib. DUSP4 depletion induced MEKi resistance, suggesting that DUSP4 is not only a biomarker but also a mediator of MEKi sensitivity.
CLINICAL TRIAL REGISTRATION


DOC-MEK (EudraCT no: 2009-018153-23).",2020,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.",['BRAF wild-type melanoma'],"['docetaxel plus selumetinib', 'docetaxel with MEK inhibitor (MEKi) selumetinib or placebo', 'placebo', 'EudraCT']","['response rates', 'dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4', 'cell survival']","[{'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2980074'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0214716', 'cui_str': 'protein phosphatase X'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",,0.222807,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK. avinash.gupta@christie.nhs.uk.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Towers', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Willenbrock', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Brant', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Darren Richard', 'Initials': 'DR', 'LastName': 'Hodgson', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sharpe', 'Affiliation': 'Oncology iMED, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Cancer BioSciences, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cutts', 'Affiliation': 'Molecular Diagnostics Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'Department of Cellular Pathology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Experimental Cancer Medicine Centre, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adelyn', 'Initials': 'A', 'LastName': 'Wise', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark Roy', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Valentine Moya', 'Initials': 'VM', 'LastName': 'Macaulay', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}]",British journal of cancer,['10.1038/s41416-019-0673-5']
3459,31746980,Minimally invasive versus standard extracorporeal circulation system in minimally invasive aortic valve surgery: a propensity score-matched study.,"OBJECTIVES


The impact of minimally invasive extracorporeal circulation (MiECC) systems on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. This study compared in-hospital and 1 year outcomes of MI-AVR interventions using MiECC systems versus conventional extracorporeal circulation (c-ECC).
METHODS


Data from 288 consecutive patients undergoing primary isolated MI-AVR using MiECC (n = 102) or c-ECC (n = 186) were prospectively collected. Treatment selection bias was addressed by the use of propensity score matching (MiECC vs c-ECC). After propensity score matching, 2 groups of 93 patients each were created.
RESULTS


Compared with c-ECC, MiECC was associated with a higher rate of autologous priming (82.4% vs 0%; P < 0.001) and a greater nadir haemoglobin (9.3 vs 8.7 g/dl; P = 0.021) level and haematocrit (27.9% vs 26.4%; P = 0.023). Patients who had MiECC were more likely to receive ultra-fast-track management (60.8% vs 26.9%; P < 0.001) and less likely to receive blood transfusions (32.7% vs 44%; P = 0.04). The in-hospital mortality rate was 1.1% in the MiECC group and 0% in the c-ECC group (P = 0.5). Those in the MiECC group had reduced rates of bleeding requiring revision (0% vs 5.3%; P = 0.031) and postoperative atrial fibrillation (AF) (30.1% vs 44.1%; P = 0.034). The 1-year survival rate was 96.8% and 97.5% for MiECC and c-ECC patients, respectively (P = 0.4).
CONCLUSIONS


MiECC systems were a safe and effective tool in patients who had MI-AVR. Compared with c-ECC, MiECC promotes ultra-fast-track management and provides better clinical outcomes as regards bleeding, blood transfusions and postoperative AF. Thus, by reducing surgical injury and promoting faster recovery, MiECC may further validate MI-AVR interventions.",2020,"Compared with c-ECC, MiECC was associated with a higher rate of autologous priming (82.4% vs 0%; P < 0.001) and a greater nadir haemoglobin (9.3 vs 8.7 g/dl; P = 0.021) level and haematocrit (27.9% vs 26.4%; P = 0.023).","['patients who had MI-AVR', '288 consecutive patients undergoing primary isolated MI-AVR using MiECC (n\u2009=\u2009102) or c-ECC (n\u2009=\u2009186', 'minimally invasive aortic valve surgery', 'patients undergoing minimally invasive aortic valve replacement (MI-AVR']","['Minimally invasive versus standard extracorporeal circulation system', 'minimally invasive extracorporeal circulation (MiECC) systems', 'MI-AVR interventions using MiECC systems versus conventional extracorporeal circulation (c-ECC', 'MiECC', 'c-ECC, MiECC']","['nadir haemoglobin', 'postoperative atrial fibrillation (AF', 'level and haematocrit', 'blood transfusions', 'rate of autologous priming', 'hospital mortality rate', '1-year survival rate', 'rates of bleeding requiring revision']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}]",288.0,0.0410782,"Compared with c-ECC, MiECC was associated with a higher rate of autologous priming (82.4% vs 0%; P < 0.001) and a greater nadir haemoglobin (9.3 vs 8.7 g/dl; P = 0.021) level and haematocrit (27.9% vs 26.4%; P = 0.023).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Berretta', 'Affiliation': 'Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Cefarelli', 'Affiliation': 'Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Montecchiani', 'Affiliation': 'Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Alfonsi', 'Affiliation': 'Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Vessella', 'Affiliation': 'Cardiac Anaesthesia and Intensive Care Unit, Lancisi Cardiovascular Center, Ancona, Italy.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Zahedi', 'Affiliation': 'Cardiac Anaesthesia and Intensive Care Unit, Lancisi Cardiovascular Center, Ancona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carozza', 'Affiliation': 'Perfusion Unit, Lancisi Cardiovascular Center, Ancona, Italy.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Munch', 'Affiliation': 'Cardiac Anaesthesia and Intensive Care Unit, Lancisi Cardiovascular Center, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Eusanio', 'Affiliation': 'Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ancona, Italy.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezz318']
3460,31750699,"The effects of mindfulness-based yogic breathing on craving, affect, and smoking behavior.","Breathing practices are often incorporated into treatments for tobacco dependence, but there is little direct research testing the efficacy of breathing practices. This study examined the effects of a mindfulness-based yogic breathing (MB) intervention versus active treatment (cognitive strategy [CS]) and no-treatment (NT) control groups on craving, affect, withdrawal, and smoking behavior. Smokers ( N  = 60; 50% female; 83% African American) were randomized to receive 20 min of MB, CS, or NT. Participants completed self-report measures before and after the manipulation and then took part in a 50-min smoking choice procedure. Afterward, participants were advised to use the techniques they learned and self-monitor smoking for 24 hr. They received 3 reminder text messages and returned to the lab the following day. MB and CS were more effective than NT in decreasing craving to smoke and perceived nicotine withdrawal. MB, but not CS, was more effective than NT in reducing negative affect. MB reduced the risk of smoking by more than twofold relative to both CS and NT during the smoking choice procedure. Participants in the MB condition smoked fewer cigarettes than those in the CS and NT conditions in the 24 hr following the manipulation. There were no differential effects of the manipulations on state mindfulness or positive affect. Mindful yogic breathing appears to be particularly effective in alleviating the acute negative effects of smoking abstinence and decreasing smoking behavior. Mindful breathing techniques are safe, simple, and cost-effective strategies that deserve additional research attention, especially among underserved populations of smokers. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Mindful yogic breathing appears to be particularly effective in alleviating the acute negative effects of smoking abstinence and decreasing smoking behavior.,['Smokers ( N  = 60; 50% female; 83% African American'],"['mindfulness-based yogic breathing (MB) intervention versus active treatment (cognitive strategy [CS]) and no-treatment (NT) control', 'NT', 'MB, CS, or NT', 'mindfulness-based yogic breathing']","['risk of smoking', 'craving, affect, and smoking behavior', 'craving, affect, withdrawal, and smoking behavior']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",2019.0,0.0165353,Mindful yogic breathing appears to be particularly effective in alleviating the acute negative effects of smoking abstinence and decreasing smoking behavior.,"[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Lotfalian', 'Affiliation': 'Department of Psychology, American University.'}, {'ForeName': 'Claire A', 'Initials': 'CA', 'LastName': 'Spears', 'Affiliation': 'Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Juliano', 'Affiliation': 'Department of Psychology, American University.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000536']
3461,32004709,Clinical Decision Support for Recognizing and Managing Hypertensive Blood Pressure in Youth: No Significant Impact on Medical Costs.,"OBJECTIVE


To evaluate economic costs from the health system perspective of an electronic health record-based clinical decision support (CDS) tool, TeenBP, designed to assist in the recognition and management of hypertension in youth.
METHODS


Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14 to 4/14/16. The 12-month change in standardized medical care costs for insured patients aged 10 to 17 years without prior hypertension were calculated for each study arm. The primary analysis compared patients with ≥1 visit with blood pressure (BP) ≥95th percentile (isolated hypertensive BP), and secondary analyses compared patients with ≥3 visits within one year with BP ≥95th percentile (incident hypertension). Generalized estimating equation models estimated the difference-in-differences in costs between groups over time.
RESULTS


Among 925 insured patients with an isolated hypertensive BP, the pre-to-post change in overall costs averaged $22 more for TeenBP CDS versus UC patients over 12 months, but this difference was not statistically significant (P = .723). Among 159 insured patients with incident hypertension, the pre-to-post change in overall costs over 12 months was higher by $227 per person on average for TeenBP CDS versus UC patients, but this difference also was not statistically significant (P = .313).
CONCLUSIONS


The TeenBP CDS intervention was previously found to significantly improve identification and management of hypertensive BP in youth, and in this study, we find that this tool did not significantly increase care costs in its first 12 months of clinical use.",2020,"METHODS


Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14-4/14/16.","['Youth', 'Twenty primary care clinics within an integrated health system', 'insured patients aged 10-17 years without prior hypertension', 'patients with ≥1 visit with blood pressure (BP) ≥95 th  percentile (isolated hypertensive BP), and secondary analyses compared patients with ≥3 visits within one year with BP ≥95 th  percentile (incident hypertension', '159 insured patients with incident hypertension', 'hypertension in youth']","['TeenBP CDS intervention', 'TeenBP CDS or usual care (UC']","['overall costs', 'Medical Costs', 'care costs']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",925.0,0.0478818,"METHODS


Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14-4/14/16.","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn. Electronic address: steven.p.dehmer@healthpartners.com.""}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Sinaiko', 'Affiliation': 'Department of Pediatrics, University of Minnesota (AR Sinaiko), Minneapolis, Minn.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Trower', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Ekstrom', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Nordin', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}, {'ForeName': 'Elyse O', 'Initials': 'EO', 'LastName': 'Kharbanda', 'Affiliation': ""HealthPartners Institute (SP Dehmer, NK Trower, SE Asche, HL Ekstrom, JD Nordin, PJ O'Connor, and EO Kharbanda), Minneapolis, Minn.""}]",Academic pediatrics,['10.1016/j.acap.2020.01.011']
3462,32206334,Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents.,"Background


Excess gestational weight gain (GWG) in pregnant adolescents is a major public health concern. Excess GWG increases risk of pregnancy complications as well as postpartum and offspring obesity and cardiometabolic disease. Prevention interventions for pregnant adults that target lifestyle modification (i.e., healthy eating/physical activity) show insufficient effectiveness. Pregnant adolescents have distinct social-emotional needs, which may contribute to excess GWG. From an interpersonal theoretical framework, conflict and low social support increase negative emotions, which in turn promote excess GWG through mechanisms such as overeating and physical inactivity.
Methods


The current manuscript describes the design of a pilot randomized controlled feasibility trial of adolescent interpersonal psychotherapy (IPT) to address social-emotional needs and prevent excess GWG. Up to 50 pregnant, healthy adolescents 13-19y, 12-18 weeks gestation are recruited from an interdisciplinary adolescent maternity hospital clinic and randomized to IPT + usual care or usual care alone. IPT involves 6 individual 60-minute sessions delivered by a trained behavioral health clinician during 12-30 weeks gestation. Sessions include relationship psychoeducation, emotion identification and expression, and teaching/role-playing communication skills. Between sessions, adolescents are instructed to complete a daily journal and to have conversations to work on relationship goals. Outcomes are assessed at baseline, mid-program, post-program, and 3-months postpartum. Primary outcomes are feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention. Secondary outcomes are perinatal social functioning, stress, depression, and eating behaviors assessed with validated surveys and interviews; perinatal physical activity and sleep measured via accelerometer; GWG from measured weights; and at 3-months postpartum only, maternal adiposity by dual energy x-ray absorptiometry, maternal insulin sensitivity derived from 2-hour oral glucose tolerance testing, and infant adiposity by air displacement plethysmography.
Discussion


This pilot trial will address a key gap in extant understanding of excess GWG prevention for a high-risk population of adolescents. If feasible and acceptable, brief psychotherapy to address social-emotional needs should be tested for its effectiveness to address excess GWG and postpartum maternal/infant health. If effective, such an approach has potential to interrupt an adverse, intergenerational cycle of social-emotional distress, obesity, and cardiometabolic disease among young mothers and their offspring.
Trial registration


ClinicalTrials.gov NCT03086161, retrospectively registered.",2020,"Primary outcomes are feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention.","['50 pregnant, healthy adolescents 13-19y, 12-18\u2009weeks gestation are recruited from an interdisciplinary adolescent maternity hospital clinic and randomized to', 'high-risk population of adolescents', 'pregnant adolescents', 'Pregnant adolescents', 'adolescents', 'pregnant adults', 'young mothers and their offspring']","['\n\n\nExcess gestational weight gain (GWG', 'IPT + usual care or usual care alone', 'interpersonal psychotherapy', 'IPT', 'adolescent interpersonal psychotherapy (IPT']","['gestational weight gain', 'pregnancy complications', 'perinatal social functioning, stress, depression, and eating behaviors assessed with validated surveys and interviews; perinatal physical activity and sleep measured via accelerometer; GWG from measured weights; and at 3-months postpartum only, maternal adiposity by dual energy x-ray absorptiometry, maternal insulin sensitivity derived from 2-hour oral glucose tolerance testing, and infant adiposity by air displacement plethysmography', 'feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention', 'relationship psychoeducation, emotion identification and expression, and teaching/role-playing communication skills']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0035822', 'cui_str': 'Role Playings'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",,0.133091,"Primary outcomes are feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention.","[{'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Shomaker', 'Affiliation': '1Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570 USA.'}, {'ForeName': 'Lauren D', 'Initials': 'LD', 'LastName': 'Gulley', 'Affiliation': '1Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570 USA.'}, {'ForeName': 'Emma L M', 'Initials': 'ELM', 'LastName': 'Clark', 'Affiliation': '1Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570 USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Hilkin', 'Affiliation': ""3Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO USA.""}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Pivarunas', 'Affiliation': '1Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570 USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Tanofsky-Kraff', 'Affiliation': '4Department of Medical and Clinical Psychology and Department of Medicine, Uniformed Services University of the Health Sciences, Department of Defense, Bethesda, MD USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""3Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO USA.""}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Barbour', 'Affiliation': '5Department of Medicine, University of Colorado School of Medicine, Aurora, CO USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Scott', 'Affiliation': ""3Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO USA.""}, {'ForeName': 'Jeanelle L', 'Initials': 'JL', 'LastName': 'Sheeder', 'Affiliation': ""3Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO USA.""}]",Pilot and feasibility studies,['10.1186/s40814-020-00578-1']
3463,32198743,Customized versus Population Growth Standards for Morbidity and Mortality Risk Stratification Using Ultrasonographic Fetal Growth Assessment at 22 to 29 Weeks' Gestation.,"OBJECTIVE


The aim of study is to compare the performance of ultrasonographic customized and population fetal growth standards for prediction adverse perinatal outcomes.
STUDY DESIGN


This was a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, in which l data were collected at visits throughout pregnancy and after delivery. Percentiles were assigned to estimated fetal weights (EFWs) measured at 22 to 29 weeks using the Hadlock population standard and a customized standard (www.gestation.net). Areas under the curve were compared for the prediction of composite and severe composite perinatal morbidity using EFW percentile.
RESULTS


Among 8,701 eligible study participants, the population standard diagnosed more fetuses with fetal growth restriction (FGR) than the customized standard (5.5 vs. 3.5%,  p  < 0.001). Neither standard performed better than chance to predict composite perinatal morbidity. Although the customized performed better than the population standard to predict severe perinatal morbidity (areas under the curve: 0.56 vs. 0.54,  p  = 0.003), both were poor. Fetuses considered FGR by the population standard but normal by the customized standard had morbidity rates similar to fetuses considered normally grown by both standards.The population standard diagnosed FGR among black women and Hispanic women at nearly double the rate it did among white women ( p  < 0.001 for both comparisons), even though morbidity was not different across racial/ethnic groups. The customized standard diagnosed FGR at similar rates across groups. Using the population standard, 77% of FGR cases were diagnosed among female fetuses even though morbidity among females was lower ( p  < 0.001). The customized model diagnosed FGR at similar rates in male and female fetuses.
CONCLUSION


At 22 to 29 weeks' gestation, EFW percentile alone poorly predicts perinatal morbidity whether using customized or population fetal growth standards. The population standard diagnoses FGR at increased rates in subgroups not at increased risk of morbidity and at lower rates in subgroups at increased risk of morbidity, whereas the customized standard does not.",2020,Fetuses considered FGR by the population standard but normal by the customized standard had morbidity rates similar to fetuses considered normally grown by both standards.,['male and female fetuses'],[],"['severe perinatal morbidity', 'fetal weights (EFWs', 'composite perinatal morbidity', 'morbidity rates', 'fetal growth restriction (FGR', 'morbidity']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]",8701.0,0.100061,Fetuses considered FGR by the population standard but normal by the customized standard had morbidity rates similar to fetuses considered normally grown by both standards.,"[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Blue', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jacob C', 'Initials': 'JC', 'LastName': 'Larkin', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Hospital of University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Scifres', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Hospital of University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Judith H', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Irvine, Orange, California.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mercer', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Parry', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah.'}]",American journal of perinatology,['10.1055/s-0040-1705114']
3464,31980285,Effects of lorcaserin on oxycodone self-administration and subjective responses in participants with opioid use disorder.,"BACKGROUND


Lorcaserin, a high-affinity 5-HT 2C  receptor agonist approved for treating obesity, decreased self-administration of oxycodone and cue-induced reinstatement of drug-seeking behavior in preclinical studies. The current investigation is the first clinical trial to evaluate the ability of lorcaserin to alter the reinforcing and subjective effects of oxycodone.
METHODS


In this 7-week inpatient trial, 12 non-treatment-seeking volunteers (11 males) with moderate-to-severe opioid use disorder were detoxified from opioids. In a randomized cross-over fashion, participants were first stabilized on lorcaserin (10 mg BID) or placebo (0 mg BID). Participants underwent a two-week testing period during which the reinforcing and subjective effects of intranasal oxycodone were examined in verbal choice, cue-exposure, and progressive-ratio choice sessions. The two testing weeks were identical with the exception that during the first week, active oxycodone (10 mg) was available during verbal choice (self-administration) sessions, and during the second week placebo oxycodone was available. Subsequently, participants were stabilized on the other medication condition (placebo or lorcaserin) and underwent the same testing procedures again.
RESULTS


Lorcaserin did not alter oxycodone self-administration. However, lorcaserin had a trend to increase ""wanting heroin"" when oxycodone was available, and to accentuate oxycodone-induced miosis.
CONCLUSION


Under the current experimental conditions, lorcaserin at a dose of 10 mg BID did not reliably decrease the abuse liability of oxycodone, even though the study was sufficiently powered (≥80 %) to detect clinically meaningful differences in the main outcome variables between the placebo and active lorcaserin condition. Future research could explore a wider dose range of lorcaserin and oxycodone.",2020,"Under the current experimental conditions, lorcaserin at a dose of 10 mg BID did not reliably decrease the abuse liability of oxycodone, even though the study was sufficiently powered (≥80 %) to detect clinically meaningful differences in the main outcome variables between the placebo and active lorcaserin condition.","['participants with opioid use disorder', '12 non-treatment-seeking volunteers (11 males) with moderate-to-severe opioid use disorder were detoxified from opioids']","['placebo or lorcaserin', 'placebo oxycodone', 'oxycodone', 'lorcaserin', 'placebo', 'active oxycodone', 'intranasal oxycodone']","['abuse liability of oxycodone', 'oxycodone self-administration and subjective responses', 'wanting heroin']","[{'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]",12.0,0.0426734,"Under the current experimental conditions, lorcaserin at a dose of 10 mg BID did not reliably decrease the abuse liability of oxycodone, even though the study was sufficiently powered (≥80 %) to detect clinically meaningful differences in the main outcome variables between the placebo and active lorcaserin condition.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA. Electronic address: lb3227@cumc.columbia.edu.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}, {'ForeName': 'Suky', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Manubay', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Mogali', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Ramey', 'Affiliation': 'Division of Therapeutics and Medical Consequences, National Institute on Drug Abuse, National Institutes of Health, 6001 Executive Boulevard, Bethesda, MD, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Irving Medical Center, 1051 Riverside Drive, Unit #120, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107859']
3465,31886682,Early substance use in the pathway from childhood attention-deficit/hyperactivity disorder (ADHD) to young adult substance use: Evidence of statistical mediation and substance specificity.,"This study tested whether early and developmentally atypical substance use mediates risk for adult substance use among children with attention-deficit/hyperactivity disorder (ADHD), and whether that risk is substance-specific. Participants were children with ADHD previously enrolled in a randomized controlled trial (RCT), and a demographically similar non-ADHD group, assessed at 2 through 16 years after the original RCT baseline. Self-reports of heavy drinking, marijuana use, daily smoking, and other illicit drug use were collected at follow-ups to establish atypically early and frequent use. Models estimated statistically mediated effects of childhood ADHD on adult substance use via early substance involvement, with planned comparisons to evaluate substance specificity. Results supported the mediation hypothesis, showing that childhood ADHD was associated with more frequent adult substance use via early substance involvement for marijuana, cigarettes, illicit drugs, and to a lesser extent, alcohol. Mediation was not escalated by comorbid childhood conduct disorder or oppositional defiant disorder except for early use of nonmarijuana illicit drugs. Substance-specificity in the mediational pathway was largely absent except for cigarette use, where ADHD-related early smoking most strongly predicted adult daily smoking. Findings from this study provide new evidence that atypically early substance use associated with childhood ADHD signals important cross-drug vulnerability by early adulthood, but cigarette use at a young age is especially associated with increased risk for habitual (daily) smoking specifically. Efforts to prevent, delay, or reduce substance experimentation should occur early and focus on factors relevant to multiple drugs of abuse in this at-risk population. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Mediation was not escalated by comorbid childhood conduct disorder or oppositional defiant disorder except for early use of nonmarijuana illicit drugs.,"['children with attention-deficit/hyperactivity disorder (ADHD', 'Participants were children with ADHD previously enrolled in a randomized controlled trial (RCT), and a demographically similar non-ADHD group, assessed at 2 through 16 years after the original RCT baseline']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]",[],[],2019.0,0.0412306,Mediation was not escalated by comorbid childhood conduct disorder or oppositional defiant disorder except for early use of nonmarijuana illicit drugs.,"[{'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Howard', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Traci M', 'Initials': 'TM', 'LastName': 'Kennedy', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hinshaw', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry and Behavioral Health.'}, {'ForeName': 'Arunima', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Cellular and Molecular Medicine.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Swanson', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Brooke S G', 'Initials': 'BSG', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000542']
3466,32096120,Burst Suppression: Causes and Effects on Mortality in Critical Illness.,"BACKGROUND


Burst suppression in mechanically ventilated intensive care unit (ICU) patients is associated with increased mortality. However, the relative contributions of propofol use and critical illness itself to burst suppression; of burst suppression, propofol, and critical illness to mortality; and whether preventing burst suppression might reduce mortality, have not been quantified.
METHODS


The dataset contains 471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons. We used multiple prediction and causal inference methods to estimate the effects connecting burst suppression, propofol, critical illness, and in-hospital mortality in an observational retrospective study. We also estimated the effects mediated by burst suppression. Sensitivity analysis was used to assess for unmeasured confounding.
RESULTS


The expected outcomes in a ""counterfactual"" randomized controlled trial (cRCT) that assigned patients to mild versus severe illness are expected to show a difference in burst suppression burden of 39%, 95% CI [8-66]%, and in mortality of 35% [29-41]%. Assigning patients to maximal (100%) burst suppression burden is expected to increase mortality by 12% [7-17]% compared to 0% burden. Burst suppression mediates 10% [2-21]% of the effect of critical illness on mortality. A high cumulative propofol dose (1316 mg/kg) is expected to increase burst suppression burden by 6% [0.8-12]% compared to a low dose (284 mg/kg). Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
CONCLUSIONS


Our analysis clarifies how important factors contribute to mortality in ICU patients. Burst suppression appears to contribute to mortality but is primarily an effect of critical illness rather than iatrogenic use of propofol.",2020,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","['471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons', 'mechanically ventilated intensive care unit (ICU) patients', 'ICU patients']","['propofol', 'Propofol']","['burst suppression burden', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0609599,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Haoqi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aboul Nour', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabaeizadeh', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Maryum', 'Initials': 'M', 'LastName': 'Shoukat', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Javed', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Kassa', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Edhi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Bordbar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Valdery Moura', 'Initials': 'VM', 'LastName': 'Junior', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Ghanta', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'M Brandon', 'Initials': 'MB', 'LastName': 'Westover', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. mwestover@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-020-00932-4']
3467,31479355,Experiment To Decrease Neighborhood Poverty Had Limited Effects On Emergency Department Use.,"Neighborhood environments are increasingly thought to affect emergency department (ED) use. However, because people decide where to live based on a range of factors, it can be challenging to identify the causal impact of living in higher-poverty neighborhoods on increased rates of ED visits. Our study leveraged the Moving to Opportunity for Fair Housing Demonstration Program, a social experiment beginning in 1994 that randomly assigned approximately 4,600 households that received federal housing assistance to different neighborhood conditions. We linked program participants in four states with an average of twelve years of administrative data on ED use (up to twenty-one years after randomization). Contrary to our expectations, we did not find a consistently significant connection between neighborhood poverty and overall ED use during this follow-up period. This result was observed for both adults and people who were children at the time of randomization, as well as for various classifications of ED visits. The findings can help direct future research that seeks to clarify the relationship between neighborhood environments and health care use.",2019,"Contrary to our expectations, we did not find a consistently significant connection between neighborhood poverty and overall ED use during this follow-up period.","['program participants in four states with an average of twelve years of administrative data on ED use (up to twenty-one years after randomization', '1994 that randomly assigned approximately 4,600 households that received federal housing assistance to different neighborhood conditions', 'adults and people who were children at the time of randomization, as well as for various classifications of ED visits']",[],[],"[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]",[],[],,0.0254174,"Contrary to our expectations, we did not find a consistently significant connection between neighborhood poverty and overall ED use during this follow-up period.","[{'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Pollack', 'Affiliation': 'Craig E. Pollack ( cpollac2@jhmi.edu ) is an associate professor in the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Shawn Du was formerly a PhD student in the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health. He is now an associate at Analysis Group in New York City.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Amanda L. Blackford is a principal biostatistician in the Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins School of Medicine, in Baltimore.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Herring', 'Affiliation': 'Bradley Herring is an associate professor in the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2019.00452']
3468,32192966,"The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study.","INTRODUCTION


A synergistic effect of the combination therapy tadalafil plus L-Arginine is conceivable in patients affected by erectile dysfunction (ED).
AIM


To evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2.5 grams in monotherapy and combination therapy.
METHODS


Recruited patients completed the International Index of Erectile Function - Erectile Function domain (IIEF-EF) and Sexual Encounter Profile diaries completed at baseline and after treatment. The survey was randomized into 3 groups with an equal allocation ratio. Group A received daily L-Arginine 2,500 mg, group B received daily tadalafil 5 mg, and group C received both daily L-Arginine 2,500 mg plus daily tadalafil 5 mg. The duration of therapy in all 3 groups was 12 weeks. Safety was assessed by evaluating all reported treatment-emergent adverse events.
MAIN OUTCOME MEASURE


The main outcome measure was the change in IIEF-EF score and in per-patient percentage of ""yes"" responses to Sexual Encounter Profile Question 3 from baseline to after treatment.
RESULTS


300 eligible patients were enrolled, and 100 subjects for each group were allocated. Based on the IIEF-EF score, the participants were divided into 3 categories: severe, moderate, and mild ED. IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5. In mild ED group, the mean IIEF-EF score increased from 22.1 ± 2.2 to 27.5 ± 2.3 in group A; from 22.1 ± 2.2 to 27.8 ± 2 in group B, and from 22.2 ± 2.2 to 29.3 ± 0.9 in group C. We report a total of 11, 53, and 67 cases of adverse events in group A, B, and C respectively.
CONCLUSIONS


Combination therapy was superior to monotherapies. Gallo L, Pecoraro S, Sarnacchiaro P, et al. The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study. Sex Med 2020;8:178-185.",2020,"IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5.","['patients affected by erectile dysfunction (ED', '300 eligible patients were enrolled, and 100 subjects for each group were allocated', 'Erectile Dysfunction']","['L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy', 'daily L-Arginine 2,500 mg plus daily tadalafil', 'tadalafil', 'L-Arginine', 'combination therapy tadalafil plus L-Arginine', 'daily L-Arginine', 'Tadalafil 5\xa0mg in Combination and in Monotherapy', 'tadalafil 5 mg and L-Arginine 2.5 grams in monotherapy and combination therapy']","['Gallo L, Pecoraro S, Sarnacchiaro P, et', 'mean IIEF-EF score', 'duration of therapy', 'IIEF-EF score', 'change in IIEF-EF score and in per-patient percentage of ""yes"" responses to Sexual Encounter Profile Question 3', 'International Index of Erectile Function - Erectile Function domain (IIEF-EF) and Sexual Encounter Profile diaries', 'effectiveness and tolerability', 'Safety']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1594297', 'cui_str': 'tadalafil 5 MG [Cialis]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",300.0,0.0481384,"IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5.","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Gallo', 'Affiliation': 'Gallo Uro-Andrology Centre, Naples, Italy. Electronic address: info@studiourologicogallo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pecoraro', 'Affiliation': 'Division of Urology, Malzoni Clinic, Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Sarnacchiaro', 'Affiliation': 'Department of Law and Economics, Unitelma Sapienza University, Rome, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Silvani', 'Affiliation': 'Division of Urology, Santa Rita Clinic, Vercelli, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Urology, Sapienza University, Rome, Italy.'}]",Sexual medicine,['10.1016/j.esxm.2020.02.003']
3469,32155616,The Efficacy of Topical Basil Essential Oil on Relieving Migraine Headaches: A Randomized Triple-Blind Study.,"OBJECTIVE


Complementary therapies have been increasingly used for the prevention and treatment of migraine so that there is a need for studies in this setting. This study sought to determine the effects of basil essential oil on the severity and frequency of migraine attack headaches.
METHODS


A triple-blind clinical trial study was performed on 144 patients diagnosed with migraine. Patients were randomly allocated by a stratified method to four groups of 36 titled basil essential oil 2, 4, 6%, and placebo groups. Medications were used topically every 8 h for 3 successive months. In addition, each individual received 325 mg of acetaminophen every 12 h. The severity and frequency of migraine attacks were measured prior to the study, at weeks 2, 4, 8, and 12. The visual analog scale was used to measure pain intensity. The marginal model and generalized estimation equations were used to compare changes in the intensity and frequency of pain over time.
RESULTS


The interaction of the dose and time factors was significant on both pain intensity (p < 0.001) and frequency of attack (p < 0.001). The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time.
CONCLUSION


Time lapse and higher doses of basil essential oil would reduce both the intensity and frequency of migraine attacks.",2020,"The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time.
",['144 patients diagnosed with migraine'],"['basil essential oil', 'placebo', 'Topical Basil Essential Oil', 'acetaminophen']","['odds ratio of higher pain intensity and rate ratio of higher frequency of attack', 'frequency of attack', 'severity and frequency of migraine attacks', 'pain intensity', 'Migraine Headaches', 'visual analog scale', 'intensity and frequency of migraine attacks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0600402', 'cui_str': 'Basil'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",144.0,0.0324228,"The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time.
","[{'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Ahmadifard', 'Affiliation': 'Young Researchers Club, Khorramabad Branch, Islamic Azad University, Khorramabad, Iran.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Yarahmadi', 'Affiliation': 'Department of Critical Care Nursing, Faculty of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran, s.yarahmadi000@gmail.com.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ardalan', 'Affiliation': 'Providence Saint Joseph Medical Center, Burbank, California, USA.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Biostatistics, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Bahrami', 'Affiliation': 'Department of Neurology, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sheikhi', 'Affiliation': 'Social Determinants of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",Complementary medicine research,['10.1159/000506349']
3470,32173766,Exercise intensity prescription in cancer survivors: ventilatory and lactate thresholds are useful submaximal alternatives to VO 2peak .,"PURPOSE


Most studies with cancer survivors use percentages of peak oxygen uptake (VO 2peak ) for intensity prescription. Lactate or ventilatory thresholds might be useful submaximal alternatives, but this has never been investigated. Therefore, we aimed at comparing three training sessions prescribed using %VO 2peak  (reference), lactate thresholds, and ventilatory thresholds in terms of meeting the vigorous-intensity zone, physiological, and psychological responses.
METHODS


Twenty breast (58 ± 10 years) and 20 prostate cancer survivors (68 ± 6 years), 3.6 ± 2.4 months after primary therapy, completed a maximal cardiopulmonary exercise test and three vigorous training sessions in randomized order: 38 min of cycling at 70% VO 2peak  (M-VO 2peak ), 97% of individual anaerobic lactate threshold (M-IAT), and 67% between ventilatory thresholds 1 and 2 (M-VT). Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment were assessed.
RESULTS


Cancer survivors exercised at 75 ± 23, 85 ± 18, and 79 ± 19 W during M-VO 2peak , M-IAT, and M-VT (p > .05). Sessions could not be completed in 3, 8, and 6 cases. Session completers showed HR of 82 ± 7, 83 ± 9, and 84 ± 8 %HR peak  and bLa of 3.7 ± 1.9, 3.9 ± 0.9, and 3.9 ± 1.5 mmol·l -1 , which was not different between sessions (p > .05). However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
CONCLUSION


All intensity prescription methods on average met the targeted intensity zone. Metabolic response was most homogeneous when using lactate thresholds.
IMPLICATIONS FOR CANCER SURVIVORS


Submaximal thresholds are at least as useful as VO 2peak  for intensity prescription in cancer survivors. Overall, slightly lower percentages should be chosen to improve durability of the training sessions.",2020,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","['cancer survivors', 'FOR CANCER SURVIVORS', 'Twenty breast (58\u2009±\u200910\xa0years) and 20 prostate cancer survivors (68\u2009±\u20096\xa0years), 3.6\u2009±\u20092.4\xa0months after primary therapy, completed a']","['Exercise intensity prescription', 'maximal cardiopulmonary exercise test and three vigorous training sessions']","['Metabolic response', 'Heart rate (HR), blood lactate concentration (bLa), perceived exertion, and enjoyment', 'variance in bLa', 'peak oxygen uptake (VO 2peak ']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",,0.0364949,"However, variance in bLa was lower in M-IAT compared to M-VO 2peak  (p = .001) and to M-VT (p = .022).
","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Schlüter', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sprave', 'Affiliation': 'Department of Radiation Oncology, University Hospital Heidelberg and National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Rosenberger', 'Affiliation': 'Working Group Exercise Oncology, Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany. friederike.rosenberger@nct-heidelberg.de.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05407-y']
3471,31344257,"Itch induction by audiovisual stimuli and histamine iontophoresis: a randomized, controlled noninferiority study.","BACKGROUND


Previous research has mainly used skin-manipulating methods to induce itch. In comparison, itch induced by audiovisual stimuli lacks direct skin manipulation.
OBJECTIVES


The aim of this double blind, noninferiority study was to test the experimental hypothesis that itch induced by audiovisual stimuli is noninferior to itch induced by histamine iontophoresis in case of priming and without priming.
METHODS


In 80 of 160 healthy volunteers itch was induced by histamine iontophoresis, while in the other 80 itch was induced by audiovisual stimulation. Forty people in each group experienced either an initial resting phase or dermal priming. Itch intensity was measured by visual analogue scales, while scratch duration and frequency were video-recorded and evaluated by two independent raters. In addition, itch quality and location were measured by self-report.
RESULTS


Itch induced by audiovisual stimuli was inferior to itch induced by histamine iontophoresis in the absence of dermal priming. However, in the case of priming, maximal itch induced by audiovisual stimuli was not inferior to maximal itch induced by histamine iontophoresis. Additionally, differences in itch quality and location were observed.
CONCLUSIONS


The finding that maximal audiovisually-induced itch was comparable with maximal histamine itch only after priming emphasizes that attention plays a dominant role in mentally-induced itch. The comparability of maximal histamine and audiovisually-induced itch in the case of priming opens up new research opportunities. What's already known about this topic? Itch is a multidimensional sensation that is altered by, among other things, attention. To induce itch in basic research, different methods are used, which are partially invasive or cause skin manipulation. Noninvasive audiovisual stimuli can be used to induce itch. What does this study add? This study investigated whether itch induced by audiovisual stimuli is noninferior to itch induced by histamine iontophoresis. Itch induced by audiovisual stimuli is noninferior with regard to maximal intensity in the case of priming. Noninferiority was not shown in the case of no priming, emphasizing the role of attention in itch induction. Histamine and audiovisually-induced itch differ in terms of quality and location, but not in affective reaction.",2020,It was shown that itch induced by audiovisual stimuli was inferior to itch induced by histamine iontophoresis in absence of dermal priming.,"['160 healthy volunteers itch was induced by', '40 persons of each group experienced either an initial resting phase or dermal priming']","['audiovisual stimuli and histamine iontophoresis', 'histamine iontophoresis']","['itch quality and its localisation', 'visual analogue scales, while scratch duration and frequency', 'Itch intensity']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",160.0,0.0546144,It was shown that itch induced by audiovisual stimuli was inferior to itch induced by histamine iontophoresis in absence of dermal priming.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marzell', 'Affiliation': 'Institute of Medical Psychology, University of Gießen, Gießen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Reichwein', 'Affiliation': 'Institute of Medical Psychology, University of Gießen, Gießen, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Gieler', 'Affiliation': 'Clinics for Dermatology and Allergology, University of Gießen, Gießen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kupfer', 'Affiliation': 'Institute of Medical Psychology, University of Gießen, Gießen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schut', 'Affiliation': 'Institute of Medical Psychology, University of Gießen, Gießen, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18368']
3472,32133525,Blood pressure in frail older adults: associations with cardiovascular outcomes and all-cause mortality.,"BACKGROUND


Blood pressure (BP) management in frail older people is challenging. An randomised controlled trial of largely non-frail older people found cardiovascular and mortality benefit with systolic (S) BP target <120 mmHg. However, all-cause mortality by attained BP in routine care in frail adults aged above 75 is unclear.
OBJECTIVES


To estimate observational associations between baseline BP and mortality/cardiovascular outcomes in a primary-care population aged above 75, stratified by frailty.
METHODS


Prospective observational analysis using electronic health records (clinical practice research datalink, n = 415,980). We tested BP associations with cardiovascular events and mortality using competing and Cox proportional-hazards models respectively (follow-up ≤10 years), stratified by baseline electronic frailty index (eFI: fit (non-frail), mild, moderate, severe frailty), with sensitivity analyses on co-morbidity, cardiovascular risk and BP trajectory.
RESULTS


Risks of cardiovascular outcomes increased with SBPs >150 mmHg. Associations with mortality varied between non-frail <85 and frail 75-84-year-olds and all above 85 years. SBPs above the 130-139-mmHg reference were associated with lower mortality risk, particularly in moderate to severe frailty or above 85 years (e.g. 75-84 years: 150-159 mmHg Hazard Ratio (HR) mortality compared to 130-139: non-frail HR = 0.94, 0.92-0.97; moderate/severe frailty HR = 0.84, 0.77-0.92). SBP <130 mmHg and Diastolic(D)BP <80 mmHg were consistently associated with excess mortality, independent of BP trajectory toward the end of life.
CONCLUSIONS


In representative primary-care patients aged ≥75, BP <130/80 was associated with excess mortality. Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities. The priority given to aggressive BP reduction in frail older people requires further evaluation.",2020,"Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities.","['frail older adults', 'a primary-care population aged above 75, stratified by frailty', 'frail older people', 'Prospective observational analysis using electronic health records (clinical practice research datalink, n\xa0=\u2009415,980', 'representative primary-care patients aged ≥75, BP <130/80 was associated with excess mortality', 'frail adults aged above 75', 'largely non-frail older people found cardiovascular and mortality benefit with systolic (S) BP target <120\xa0mmHg', 'non-frail <85 and frail 75-84-year-olds and all above 85 years']","['Diastolic(D)BP', 'Blood pressure (BP) management']","['baseline BP and mortality/cardiovascular outcomes', 'mortality', 'Blood pressure', 'mmHg Hazard Ratio (HR) mortality', 'co-morbidity, cardiovascular risk and BP trajectory']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0079320', 'cui_str': 'Mortality, Excess'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1272452', 'cui_str': 'Manage blood pressure taking'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0600773,"Hypertension was not associated with increased mortality at ages above 85 or at ages 75-84 with moderate/severe frailty, perhaps due to complexities of co-existing morbidities.","[{'ForeName': 'Jane A H', 'Initials': 'JAH', 'LastName': 'Masoli', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Delgado', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Pilling', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strain', 'Affiliation': 'Department of Healthcare for Older People, Royal Devon and Exeter Hospital, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Melzer', 'Affiliation': 'Epidemiology and Public Health Group, University of Exeter Medical School, Exeter, UK.'}]",Age and ageing,['10.1093/ageing/afaa028']
3473,32167011,Oral delivery of Hyperimmune bovine serum antibodies against CS6-expressing enterotoxigenic  Escherichia coli  as a prophylactic against diarrhea.,"BACKGROUND


. Oral administration of bovine antibodies active against enterotoxigenic  Escherichia coli  (ETEC) have demonstrated safety and efficacy against diarrhea in human challenge trials. The efficacy of bovine serum immunoglobulins (BSIgG) against recombinant colonization factor CS6 or whole cell ETEC strain B7A was assessed against challenge with the CS6-expressing B7A.
METHODS


. This was a randomized, double-blind, placebo-controlled trial in which healthy adults received oral hyperimmune BSIgG anti-CS6, anti-B7A whole cell killed or non-hyperimmune BSIgG (placebo) in a 1:1:1 ratio then challenged with ETEC B7A. Two days pre-challenge, volunteers began a thrice daily, seven day course of immunoprophylaxis. On day 3, subjects received 1 × 10 10  CFUs of B7A. Subjects were observed for safety and the primary endpoint of moderate-severe diarrhea (MSD).
RESULTS


. A total of 59 volunteers received product and underwent ETEC challenge. The BSIgG products were well-tolerated across all subjects. Upon challenge, 14/20 (70%) placebo recipients developed MSD, compared to 12/19 (63%;  p  = .74) receiving anti-CS6 BSIgG and 7/20 (35%;  p  = .06) receiving anti-B7A BSIgG. Immune responses to the ETEC infection were modest across all groups.
CONCLUSIONS


. Bovine-derived serum antibodies appear safe and well tolerated. Antibodies derived from cattle immunized with whole cell B7A provided 50% protection against MSD following B7A challenge; however, no protection was observed in subjects receiving serum antibodies targeting CS6. The lack of observed efficacy in this group may be due to low CS6 surface expression on B7A, the high dose challenge inoculum and/or the use of serum derived antibodies versus colostrum-derived antibodies.",2020,"Antibodies derived from cattle immunized with whole cell B7A provided 50% protection against MSD following B7A challenge; however, no protection was observed in subjects receiving serum antibodies targeting CS6.","['59 volunteers received product and underwent ETEC challenge', 'healthy adults']","['placebo', 'Hyperimmune bovine serum antibodies', 'bovine serum immunoglobulins (BSIgG', 'bovine antibodies active against enterotoxigenic  Escherichia coli  (ETEC', 'oral hyperimmune BSIgG anti-CS6, anti-B7A whole cell killed or non-hyperimmune BSIgG (placebo']","['MSD', 'moderate-severe diarrhea (MSD']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0580797', 'cui_str': 'E coli, Enterotoxigenic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521763', 'cui_str': 'Killed'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}]",59.0,0.190712,"Antibodies derived from cattle immunized with whole cell B7A provided 50% protection against MSD following B7A challenge; however, no protection was observed in subjects receiving serum antibodies targeting CS6.","[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Porter', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Bourgeois', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Duplessis', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maciel', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Gutierrez', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'DeNearing', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Adjoodani', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adkinson', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Testa', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Feijoo', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Alcala', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brubaker', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beselman', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sack', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Halpern', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trop', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'SAB Biotherapeutics Inc , Sioux Falls, SD, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'SAB Biotherapeutics Inc , Sioux Falls, SD, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sullivan', 'Affiliation': 'SAB Biotherapeutics Inc , Sioux Falls, SD, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Riddle', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Joseph', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Poole', 'Affiliation': 'The Henry M. Jackson Foundation , Bethesda, MD, USA.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Prouty', 'Affiliation': 'Enteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.'}]",Gut microbes,['10.1080/19490976.2020.1732852']
3474,32151752,Combined intervention approaches for initiating and maintaining physical activity in depressed individuals: design and rationale of the Project MOVE randomized clinical trial.,"INTRODUCTION


Regular engagement in physical activity decreases risks for many chronic conditions, and may also improve depression symptoms. However, rates of physical activity and adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
METHODS


This is a study protocol for Project MOVE. This study is a theoretically-driven, 3-arm randomized controlled trial for increasing physical activity with depressed adults. Each successive arm includes an added component that may serve to increase and maintain physical activity. The arms are: 1) Brief advice (BA) to exercise alone (minimal treatment control condition); 2) BA + supervised and home-based exercise (SHE) + health education (HE; serves as contact control for CBEX); and 3) BA + SHE +cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX). The target sample size is 240. Assessments are conducted at baseline, Month 1.5, end of intervention (month 3), and at 6 and 9 months. The primary outcome is minutes of moderate-to-vigorous physical activity, assessed via an accelerometer. Secondary outcomes include cardiorespiratory fitness, body composition, and depression, and maintenance of moderate-vigorous physical activity through 6 and 9 month follow-ups. Mediators and moderators derived from behavior change theories, including the Health Behavior Model, Self-Determination Theory, and Social Ecological Theory, will be examined.
CONCLUSION


Project MOVE is designed to test primarily whether both a structured exercise program (SHE) and a cognitive-behavioral group (CBEX) increase physical activity in depressed adults during both a 3-month intervention period, and during the 6-months that follow.",2020,"However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
","['adults with depression', 'depressed individuals']","['regular exercise regimen: 1) brief advice (BA) to exercise only; 2) BA + supervised and home-based exercise (SHE)\u202f+\u202fcognitive behavioral sessions (CBEX); and BA+SHE + health education (HE', 'BA + SHE + CBEX']","['cardiorespiratory fitness, body composition, and depression, and maintenance of MVPA through 6 and 9\u202fmonth follow-ups', 'MVPA levels', 'minutes of moderate-to-vigorous physical activity (MVPA), objectively assessed by accelerometry data', 'rates of PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0418878', 'cui_str': 'Advice to exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018701'}, {'cui': 'C2724208', 'cui_str': '++'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",,0.0680391,"However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals.
","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Sillice', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA. Electronic address: marie_sillice@brown.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Epstein-Lubow', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Department of Health Services, Policy and Practice of Brown University, Providence, RI, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Battle', 'Affiliation': ""Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA; Center for Women's Behavioral Health, Women & Infants' Hospital of Rhode Island, Providence, RI, USA.""}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Caviness', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Psychosocial Research Program, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Abrantes', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA; Behavioral Medicine & Addiction Research, Butler Hospital, Providen,ce, RI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105974']
3475,31364415,A pilot clinical study of the neuromuscular blocker rocuronium to reduce the duration of ventilation after organophosphorus insecticide poisoning.,"Background:  A common manifestation of organophosphorus insecticide self-poisoning is prolonged respiratory failure due to neuromuscular junction dysfunction and likely nicotinic receptor overstimulation. We aimed at collecting preliminary data on whether addition of the competitive nicotinic antagonist rocuronium to standard early therapy might be clinically feasible and associated with reduced duration of ventilation. Methods:  A pilot three-arm dose-response phase II trial was set up to compare bolus doses of rocuronium bromide titrated to produce initial >95% or 50% inhibition of neuromuscular function, measured using acceleromyography, plus standard treatment, versus standard treatment alone. After attaining inhibition, patients receiving bolus rocuronium then received rocuronium infusions for a maximum of 120 h. Primary outcome was duration of intubation; secondary outcome was case fatality. Plasma butyrylcholinesterase activity was measured throughout the inpatient stay. Blood was analysed to confirm the organophosphorus insecticide ingested. Results:  Forty-five patients were randomised to receive: rocuronium to initially attain 95% inhibition (Roc>95,  n  = 15), rocuronium to initially attain 50% inhibition (Roc50,  n  = 14), or no rocuronium (control,  n  = 16). The most commonly ingested pesticide was profenofos (29/45, 64.4%). Butyrylcholinesterase activity remained severely inhibited for the duration of the study for most patients. Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842). When excluding patients who died, median [IQR] duration of intubation was significantly longer in the Roc50 (259.5 [176-385] h) and Roc>95 (226.8 [186-355] h) groups compared to controls (88.5 [47-160] h,  p  = .0162 and  p  = .0016, respectively). Conclusions:  In this pilot dose-response study, we found no evidence that rocuronium in addition to standard therapy reduced the duration of intubation. It is possible that it worsened neuromuscular junction function. Further clinical research, including testing of shorter duration regimens, needs to be performed before nicotinic antagonists can be used in the clinical management of OP poisoning.",2020,"Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842).","['after organophosphorus insecticide poisoning', 'Results:  Forty-five patients']","['rocuronium infusions', 'rocuronium bromide', 'rocuronium', 'rocuronium to initially attain 95% inhibition (Roc>95,  n \u2009=\u200915), rocuronium to initially attain 50% inhibition (Roc50,  n \u2009=\u200914), or no rocuronium', 'neuromuscular blocker rocuronium', 'competitive nicotinic antagonist rocuronium']","['duration of ventilation', 'duration of intubation', 'duration of intubation; secondary outcome was case fatality', 'died, median [IQR] duration of intubation', 'Case fatality', 'Butyrylcholinesterase activity', 'Plasma butyrylcholinesterase activity']","[{'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1628982', 'cui_str': 'Percent inhibition'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular Blockers'}, {'cui': 'C0242956', 'cui_str': 'Nicotinic Antagonists'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0728810', 'cui_str': 'Pseudocholinesterase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",45.0,0.206977,"Case fatality was 9/45 (20%) and similar across study arms: control 3/16 (18.8%), Roc50 4/14 (28.6%) and Roc>95 2/15 (13.3%) ( p  = .5842).","[{'ForeName': 'Jeevan', 'Initials': 'J', 'LastName': 'Dhanarisi', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Fathima', 'Initials': 'F', 'LastName': 'Shihana', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Harju', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Mohamed', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Vasundhara', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Pharmacology, Toxicology, & Therapeutics, University/BHF Centre for Cardiovascular Science, and Centre for Pesticide Suicide Prevention, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Shahmy', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Vanninen', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Kostiainen', 'Affiliation': 'VERIFIN, Finnish Institute for Verification of the Chemical Weapons Convention, Department of Chemistry, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Gawarammana', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eddleston', 'Affiliation': 'South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.'}]","Clinical toxicology (Philadelphia, Pa.)",['10.1080/15563650.2019.1643467']
3476,30733197,Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial.,"OBJECTIVE


To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI).
DESIGN


Two group parallel, assessor blinded, pragmatic randomised controlled trial.
SETTING


Secondary and tertiary care centres across seven NHS England sites.
PARTICIPANTS


222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle <20 degrees).
INTERVENTIONS


Participants in the physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care.
MAIN OUTCOME MEASURES


The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment.
RESULTS


At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (P<0.001)). No serious adverse events were reported in either group.
CONCLUSIONS


Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01893034.",2019,Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme.,"['patients with symptomatic femoroacetabular impingement (FAI', 'symptomatic femoroacetabular impingement', 'Secondary and tertiary care centres across seven NHS England sites', '222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging', 'Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle <20 degrees', 'Patients with symptomatic FAI']","['arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care', 'Arthroscopic hip surgery', 'physiotherapy programme', 'physiotherapy and activity modification', 'arthroscopic hip surgery', 'physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control', 'arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification', 'arthroscopic hip surgery with physiotherapy and activity modification']","['mean HOS ADL', 'hip outcome score activities of daily living subscale (HOS ADL', 'additional patient reported outcome measures and clinical assessment', 'serious adverse events', 'Mean HOS ADL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1328407', 'cui_str': 'Hip Dysplasia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]","[{'cui': 'C0750934', 'cui_str': 'Arthroscopic Surgical Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",222.0,0.165312,Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme.,"[{'ForeName': 'Antony J R', 'Initials': 'AJR', 'LastName': 'Palmer', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK antony.palmer@ndorms.ox.ac.uk.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Ayyar Gupta', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Fernquest', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Rombach', 'Affiliation': 'Centre for Statistics in Medicine, NDORMS, University of Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, NDORMS, University of Oxford, UK.'}, {'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Khanduja', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Tom C B', 'Initials': 'TCB', 'LastName': 'Pollard', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'McCaskie', 'Affiliation': 'Division of Trauma and Orthopaedic Surgery, University of Cambridge, UK.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': 'Tony J M D', 'Initials': 'TJMD', 'LastName': 'Andrade', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': 'Sion', 'Initials': 'S', 'LastName': 'Glyn-Jones', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.l185']
3477,32046499,"App-based mindfulness meditation for psychological distress and adjustment to college in incoming university students: a pragmatic, randomised, waitlist-controlled trial.","Objective and Design:  In a pragmatic, randomised, waitlist-controlled trial we tracked 250 first-year university students who were randomly assigned to 3 months of a mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n  = 124) or semester 2 (waitlist,  n  = 126).  Main Outcome Measures:  Students reported their distress, college adjustment, resilience, self-efficacy, and mindfulness, at 3 timepoints: the beginning of semester 1, the beginning of semester 2, and the end of the academic year. With participants' permission, the university provided academic achievement data and Headspace provided app use data.  Results:  Evidence for improvements in distress at the beginning of semester 2 was weak (intervention vs. waitlist) and app use was low ( M  = 7.91, SD = 15.16 sessions). Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users. App initiation and persistence beyond the first week was higher when the app was provided in semester 1 than semester 2 (66.1% vs. 44.4%; 46.0% vs. 32.5%).  Conclusion:  Headspace use was associated with small improvements in distress and college adjustment in first-year university students. Intervening at the beginning of the academic year may encourage uptake.",2020,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","['psychological distress and adjustment to college in incoming university students', '250 first-year university students']","['App-based mindfulness meditation', 'mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n \u2009=\u2009124) or semester 2 (waitlist,  n \u2009=\u2009126']","['psychological distress', 'distress, college adjustment, resilience, self-efficacy, and mindfulness', 'distress']","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",250.0,0.0485816,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","[{'ForeName': 'Jayde A M', 'Initials': 'JAM', 'LastName': 'Flett', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Riordan', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Harlene', 'Initials': 'H', 'LastName': 'Hayne', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}]",Psychology & health,['10.1080/08870446.2019.1711089']
3478,32004998,Enhancing panic and smoking reduction treatment with D-Cycloserine: A pilot randomized clinical trial.,"In this placebo-controlled randomized clinical trial, we examined the efficacy of 250 mg d-cycloserine (DCS) for enhancing the effects of cognitive behavior therapy targeting anxiety sensitivity reduction in the context of smoking cessation treatment among adults with a history of panic attacks. We hypothesized that DCS would enhance treatment of our mechanistic targets-anxiety sensitivity and panic and related symptoms-and result in greater smoking abstinence. A total of 53 smokers were randomized to a 7-week integrated treatment and received study medication (DCS or placebo) prior to sessions 3-5; these sessions emphasized interoceptive exposure practice. Nicotine replacement therapy was initiated at session 5 (quit date). We found that DCS augmentation led to greater reductions of one (anxiety sensitivity) of two of our mechanistic targets at early but not late assessments, and that engaging that target predicted better smoking outcomes. However, there was no evidence of group (DCS vs. placebo) differences in smoking cessation success at treatment endpoint or follow-up evaluations. Hence, although we found that DCS can enhance treatment targeting a smoking maintaining factor, additional strategies appear to be needed to significantly affect smoking outcomes.",2020,"We found that DCS augmentation led to greater reductions of one (anxiety sensitivity) of two of our mechanistic targets at early but not late assessments, and that engaging that target predicted better smoking outcomes.","['53 smokers', 'adults with a history of panic attacks']","['cognitive behavior therapy', '7-week integrated treatment and received study medication (DCS or placebo', 'Nicotine replacement therapy', 'D-Cycloserine', 'placebo', 'DCS', '250 mg d-cycloserine (DCS']",['smoking cessation success'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086769', 'cui_str': 'Panic Attacks'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",53.0,0.0948728,"We found that DCS augmentation led to greater reductions of one (anxiety sensitivity) of two of our mechanistic targets at early but not late assessments, and that engaging that target predicted better smoking outcomes.","[{'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States. Electronic address: smits@utexas.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, 3695 Cullen Boulevard, Suite 104, Houston, TX, 77204, United States; Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Houston, TX 77030, United States.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Psychological and Brain Sciences, Boston University, 64 Cummington Mall, Boston, MA, 02215, United States.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, 1930 Monroe St. #200, Madison, WI, 53711, United States.'}, {'ForeName': 'Scarlett O', 'Initials': 'SO', 'LastName': 'Baird', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States.'}, {'ForeName': 'Brooke Y', 'Initials': 'BY', 'LastName': 'Kauffman', 'Affiliation': 'Department of Psychology, University of Houston, 3695 Cullen Boulevard, Suite 104, Houston, TX, 77204, United States.'}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Lee-Furman', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Alavi', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Dutcher', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, The University of Texas at Austin, 305 E. 23rdStreet, Austin, TX, 78712, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rosenfield', 'Affiliation': 'Rosenfield Analytics, 14909 Bellbrook Dr., Dallas, TX, 75254, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, 6116 N. Central Expressway, Suite 1300, Dallas, TX, 75206, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107877']
3479,31332549,Therapeutic effect of vitamin D supplementation on allergic rhinitis.,"PURPOSE


In this study, we aimed to determine whether short-term (2 months) vitamin D supplementation could improve the allergic symptoms in AR patients.
METHODS


A randomized double-blind placebo-controlled clinical trial was performed on allergic rhinitis patients with vitamin D deficiency from Nov. 2017-2018. 80 cases with allergic rhinitis and vitamin D deficiency were divided into two groups and vitamin D plus routine antihistamine medication (cetirizine) was prescribed for the study group, whereas the control group received cetirizine plus placebo. The clinical symptoms questionnaire was completed at baseline and after 4 and 8 weeks of treatment initiation. Vitamin D levels were re-measured at the end of the 8-week treatment course.
RESULTS


In total, 80 patients with allergic rhinitis and vitamin D deficiency were enrolled. Among them, 35 cases and 33 controls visited the clinic after 8 weeks; the mean age in the aforementioned groups was 29.68 years and 29.13 years demonstrating no meaningful difference (P > 0.05). At study initiation, the mean vitamin D level was 14 ng/ml and 14.67 ng/ml in the study and control groups, respectively, indicating no significant difference (P = 0.189). The mean serum vitamin D level at 8 weeks of treatment in the study group (24.08 ng/ml) indicated a statistically meaningful difference with the mean vitamin D level at baseline (P < 0.001). Comparison of the mean scores of symptoms severity showed no significant difference between the two groups at study initiation and 4 weeks later (P = 0.073), whereas a significant difference was obtained between baseline and 8 weeks of treatment initiation (P = 0.007).
CONCLUSION


Based on the findings of the present study, it can be concluded that vitamin D supplementation along with antihistamines can result in relative symptoms improvement in AR patients with vitamin D deficiency.",2019,"Comparison of the mean scores of symptoms severity showed no significant difference between the two groups at study initiation and 4 weeks later (P = 0.073), whereas a significant difference was obtained between baseline and 8 weeks of treatment initiation (P = 0.007).
","['AR patients with vitamin D deficiency', '80 cases with allergic rhinitis and vitamin D deficiency', 'AR patients', '80 patients with allergic rhinitis and vitamin D deficiency were enrolled', 'allergic rhinitis patients with vitamin D deficiency from Nov. 2017-2018']","['vitamin D supplementation', 'short-term (2\xa0months) vitamin D supplementation', 'placebo', 'cetirizine plus placebo', 'vitamin D plus routine antihistamine medication (cetirizine']","['allergic rhinitis', 'Vitamin D levels', 'mean scores of symptoms severity', 'mean vitamin D level', 'mean serum vitamin D level', 'allergic symptoms', 'clinical symptoms questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",80.0,0.136552,"Comparison of the mean scores of symptoms severity showed no significant difference between the two groups at study initiation and 4 weeks later (P = 0.073), whereas a significant difference was obtained between baseline and 8 weeks of treatment initiation (P = 0.007).
","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bakhshaee', 'Affiliation': 'Sinus and Surgical Endoscopic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Sharifian', 'Affiliation': 'Sinus and Surgical Endoscopic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Freshteh', 'Initials': 'F', 'LastName': 'Esmatinia', 'Affiliation': 'Sinus and Surgical Endoscopic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Rasoulian', 'Affiliation': 'Sinus and Surgical Endoscopic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. rasoulianb@mums.ac.ir.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Endocrinology, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05546-x']
3480,31746224,"Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer.","On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer. Regulatory approval was based on the National Cancer Institute-sponsored Gynecologic Oncology Group (GOG) protocol 0218, the Phase III, randomized, placebo-controlled, double-blind, multi-center and multi-national clinical trial that met its primary end point, progression-free survival. Bevacizumab is now approved in the frontline, platinum-sensitive recurrent and platinum-resistant recurrent settings for epithelial ovarian cancer. This review will address the broad range of clinical trials addressing the efficacy of bevacizumab use in ovarian cancer.",2020,"On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer.","['women with newly diagnosed ovarian cancer', 'ovarian cancer']","['placebo', 'bevacizumab, in combination with chemotherapy', 'bevacizumab', 'Bevacizumab']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.211324,"On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer.","[{'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Haunschild', 'Affiliation': 'Clinical Instructor, Department of Obstetrics & Gynecology, Research Fellow, Division of Gynecologic Oncology, University of California, 333 City Blvd West, Suite 1400, Orange, CA 92868, USA.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'Professor & Division Director, Director, Division of Gynecologic Oncology, University of California, 333 City Blvd, Orange, CA 92868, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0042']
3481,30635141,Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial.,"BACKGROUND


Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small trials have suggested that supplementing the enteral diet of very preterm infants with lactoferrin, an antimicrobial protein processed from cow's milk, prevents infections and associated complications. The aim of this large randomised controlled trial was to collect data to enhance the validity and applicability of the evidence from previous trials to inform practice.
METHODS


In this randomised placebo-controlled trial, we recruited very preterm infants born before 32 weeks' gestation in 37 UK hospitals and younger than 72 h at randomisation. Exclusion criteria were presence of a severe congenital anomaly, anticipated enteral fasting for longer than 14 days, or no realistic prospect of survival. Eligible infants were randomly assigned (1:1) to receive either enteral bovine lactoferrin (150 mg/kg per day; maximum 300 mg/day; lactoferrin group) or sucrose (same dose; control group) once daily until 34 weeks' postmenstrual age. Web-based randomisation minimised for recruitment site, gestation (completed weeks), sex, and single versus multifetal pregnancy. Parents, caregivers, and outcome assessors were unaware of group assignment. The primary outcome was microbiologically confirmed or clinically suspected late-onset infection (occurring >72 h after birth), which was assessed in all participants for whom primary outcome data was available by calculating the relative risk ratio with 95% CI between the two groups. The trial is registered with the International Standard Randomised Controlled Trial Number 88261002.
FINDINGS


We recruited 2203 participants between May 7, 2014, and Sept 28, 2017, of whom 1099 were assigned to the lactoferrin group and 1104 to the control group. Four infants had consent withdrawn or unconfirmed, leaving 1098 infants in the lactoferrin group and 1101 in the sucrose group. Primary outcome data for 2182 infants (1093 [99·5%] of 1098 in the lactoferrin group and 1089 [99·0] of 1101 in the control group) were available for inclusion in the modified intention-to-treat analyses. 316 (29%) of 1093 infants in the intervention group acquired a late-onset infection versus 334 (31%) of 1089 in the control group. The risk ratio adjusted for minimisation factors was 0·95 (95% CI 0·86-1·04; p=0·233). During the trial there were 16 serious adverse events for infants in the lactoferrin group and 10 for infants in the control group. Two events in the lactoferrin group (one case of blood in stool and one death after intestinal perforation) were assessed as being possibly related to the trial intervention.
INTERPRETATION


Enteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants. These data do not support its routine use to prevent late-onset infection and associated morbidity or mortality in very preterm infants.
FUNDING


UK National Institute for Health Research Health Technology Assessment programme (10/57/49).",2019,"INTERPRETATION


Enteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants.","['very preterm infants', 'Four infants had consent withdrawn or unconfirmed, leaving 1098 infants in the lactoferrin group and 1101 in the sucrose group', 'Eligible infants', '2182 infants (1093 [99·5%] of 1098 in the lactoferrin group and 1089 [99·0] of 1101 in the control group', 'We recruited 2203 participants between May 7, 2014, and Sept 28, 2017, of whom 1099 were assigned to the lactoferrin group and 1104 to the control group', ""very preterm infants born before 32 weeks' gestation in 37 UK hospitals and younger than 72 h at randomisation""]","['placebo', 'lactoferrin', 'bovine lactoferrin', ""lactoferrin group) or sucrose (same dose; control group) once daily until 34 weeks' postmenstrual age"", 'Enteral lactoferrin supplementation', 'enteral bovine lactoferrin']","['adverse events', 'blood in stool and one death after intestinal perforation', 'late-onset infection', 'relative risk ratio', 'microbiologically confirmed or clinically suspected late-onset infection', 'risk of late-onset infection']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1321898', 'cui_str': 'Bloody stool'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2203.0,0.474052,"INTERPRETATION


Enteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)32221-9']
3482,32017677,Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.,"Little information exists regarding Ebola vaccine rVSVΔG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.",2020,Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]).,['84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment'],"['rVSVΔ-ZEBOV-GP Ebola Vaccine', 'Vaccine Against Ebola']","['congenital anomalies', 'pregnancy loss', 'Pregnancy loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}]",,0.215026,Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]).,"[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Legardy-Williams', 'Affiliation': ''}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Goldstein', 'Affiliation': ''}, {'ForeName': 'Olamide D', 'Initials': 'OD', 'LastName': 'Jarrett', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Szefer', 'Affiliation': ''}, {'ForeName': 'Augustin E', 'Initials': 'AE', 'LastName': 'Fombah', 'Affiliation': ''}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Tinker', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Samai', 'Affiliation': ''}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Mahon', 'Affiliation': ''}]",Emerging infectious diseases,['10.3201/eid2603.191018']
3483,30699054,A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.,"BACKGROUND


E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.
METHODS


We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.
RESULTS


A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.
CONCLUSIONS


E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).",2019,"The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9).","['886 participants underwent randomization', 'We randomly assigned adults attending U.K. National Health Service stop-smoking services to either']","['E-Cigarettes versus Nicotine-Replacement Therapy', 'nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter']","['Overall, throat or mouth irritation', 'sustained abstinence for 1 year', 'incidence of wheezing or shortness of breath', '1-year abstinence rate', 'incidence of cough and phlegm production', 'participant-reported treatment usage and respiratory symptoms', 'nausea']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3179143', 'cui_str': 'Nicotine Replacement Products'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",886.0,0.146666,"The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bisal', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Goniewicz', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Hayden J', 'Initials': 'HJ', 'LastName': 'McRobbie', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa1808779']
3484,31104069,Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial.,"Importance


Previous research suggested that soluble human recombinant thrombomodulin may reduce mortality among patients with sepsis-associated coagulopathy.
Objective


To determine the effect of human recombinant thrombomodulin vs placebo on 28-day all-cause mortality among patients with sepsis-associated coagulopathy.
Design, Setting, and Participants


The SCARLET trial was a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study conducted in intensive care units at 159 sites in 26 countries. All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150 × 109/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion. The final date of follow-up was February 28, 2019.
Interventions


Patients with sepsis-associated coagulopathy were randomized and treated with an intravenous bolus or a 15-minute infusion of thrombomodulin (0.06 mg/kg/d [maximum, 6 mg/d]; n = 395) or matching placebo (n = 405) once daily for 6 days.
Main Outcome and Measures


The primary end point was 28-day all-cause mortality.
Results


Among 816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set. In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32). The absolute risk difference was 2.55% (95% CI, -3.68% to 8.77%). The incidence of serious major bleeding adverse events (defined as any intracranial hemorrhage; life-threatening bleeding; or bleeding event classified as serious by the investigator, with administration of at least 1440 mL [typically 6 units] of packed red blood cells over 2 consecutive days) was 23 of 396 patients (5.8%) in the thrombomodulin group and 16 of 404 (4.0%) in the placebo group.
Conclusions and Relevance


Among patients with sepsis-associated coagulopathy, administration of a human recombinant thrombomodulin, compared with placebo, did not significantly reduce 28-day all-cause mortality.
Trial Registration


ClinicalTrials.gov Identifier: NCT01598831.",2019,"In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32).","['All adult patients admitted to one of the participating intensive care units between October 2012 and March 2018 with sepsis-associated coagulopathy and concomitant cardiovascular and/or respiratory failure, defined as an international normalized ratio greater than 1.40 without other known etiology and a platelet count in the range of 30 to 150\u2009×\u2009109/L or a greater than 30% decrease in platelet count within 24 hours, were considered for inclusion', 'Patients with sepsis-associated coagulopathy', 'patients with sepsis-associated coagulopathy', '816 randomized patients, 800 (mean age, 60.7 years; 437 [54.6%] men) completed the study and were included in the full analysis set', 'intensive care units at 159 sites in 26 countries', 'Patients With Sepsis-Associated Coagulopathy']","['matching placebo', 'human recombinant thrombomodulin vs placebo', 'placebo', 'intravenous bolus or a 15-minute infusion of thrombomodulin', 'Recombinant Human Soluble Thrombomodulin']","['Mortality', 'absolute risk difference', '28-day all-cause mortality', 'cause mortality rate', 'incidence of serious major bleeding adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",816.0,0.638967,"In these patients, the 28-day all-cause mortality rate was not statistically significantly different between the thrombomodulin group and the placebo group (106 of 395 patients [26.8%] vs 119 of 405 patients [29.4%], respectively; P = .32).","[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Francois', 'Affiliation': 'ICU Department, Inserm CIC-1435 & UMR-1092, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Zabolotskikh', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Transfusiology, Kuban State Medical University, Krasnodar, Russia.'}, {'ForeName': 'Mradul Kumar', 'Initials': 'MK', 'LastName': 'Daga', 'Affiliation': 'Department of Medicine, Maulana Azad Medical College and associated hospitals, New Delhi, India.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Kirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Faculté de Médecine, Université de Strasbourg (UNISTRA), Hôpitaux Universitaires de Strasbourg, Service de Réanimation, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Mercier', 'Affiliation': 'Médecine Intensive Réanimation, CHRU de Tours, Tours, France.'}, {'ForeName': 'Suzana M', 'Initials': 'SM', 'LastName': 'Lobo', 'Affiliation': 'Intensive Care Division, Hospital de Base, São José do Rio Preto, SP, Brazil.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Barie', 'Affiliation': 'Departments of Surgery and Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Crowther', 'Affiliation': ""Department of Medicine, McMaster University and St Joseph's Hospital, Hamilton, Canada.""}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Esmon', 'Affiliation': 'Coagulation Biology Laboratory, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Pathology and Pharmacology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Gando', 'Affiliation': 'Acute and Critical Care Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Gorelick', 'Affiliation': 'Zymo Consulting Group LLC, Newtown Square, Massachusetts.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Department of Medicine, University College London Hospitals and Cardiometabolic Programme-NIHR UCLH/UCL BRC, London, United Kingdom.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Universite´Paris Descartes, Sorbonne Paris Cite´, Faculte´ de Me´-decine Cochin University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Opal', 'Affiliation': 'Division of Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Parrillo', 'Affiliation': 'Department of Medicine, New Jersey Medical School of Rutgers University, Hackenseck.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Tsuruta', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fineberg', 'Affiliation': 'Asahi-Kasei Pharma America Corporation, Waltham, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.5358']
3485,30847828,Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial.,"BACKGROUND


Pre-treatment factors that increase smokers' risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown.
OBJECTIVE


To identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES.
DESIGN


A prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial.
PARTICIPANTS


Smokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders.
INTERVENTIONS


Bupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up.
MAIN MEASURES


Primary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.
KEY RESULTS


The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study.
CONCLUSIONS


Irrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01456936.",2019,The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%).,"['N\u2009=\u20094050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N\u2009=\u20092882; 71%), anxiety (N\u2009=\u2009782; 19%), and psychotic (N\u2009=\u2009386; 10%) disorders', 'smokers with psychiatric disorders', 'Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study', 'Smokers without (N\u2009=\u20093984; NPC)/with']","['Bupropion, 150\xa0mg twice daily, or varenicline, 1\xa0mg twice daily, versus active control (nicotine patch, 21\xa0mg/day with taper) and placebo']","['HADS anxiety score', 'incidence of a composite measure of moderate/severe NPSAEs', 'incidence of moderate to severe NPSAEs', 'suicidal ideation and/or behavior', 'current anxiety or prior suicidal ideation', 'absolute risk of occurrence of the NPSAE endpoint']","[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0931029,The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%).,"[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA. ranthenelli@ucsd.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaffney', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'University College, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'St Aubin', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Krishen', 'Affiliation': 'PAREXEL International on behalf of GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04858-2']
3486,30815861,Promoting Compliance in Children Referred to Child Protective Services: A Randomized Clinical Trial.,"Early experiences of maltreatment have long-term negative effects on children's compliance. This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services. Participants included 101 parent-child dyads who received either ABC or a control intervention when children were infants (M = 9.4 months old, SD = 6.1). When children were approximately 36 months old (M = 38.5, SD = 3.0), ABC children demonstrated significantly better compliance than control children. Further, parent sensitivity, measured 1 month post intervention when children were, on average, 18.4 months old (SD = 6.9) partially mediated the effect of ABC on child compliance at 36 months old.",2020,This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services.,"['children who had been referred to Child Protective Services', 'Participants included 101 parent-child dyads who received either', 'Children Referred to Child Protective Services']","['brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC', 'ABC or a control intervention']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],101.0,0.0465658,This randomized clinical trial examined whether a brief preventative intervention (Attachment and Biobehavioral Catch-up; ABC) was effective in enhancing compliance in children who had been referred to Child Protective Services.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lind', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'University of Maryland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware.'}]",Child development,['10.1111/cdev.13207']
3487,30798568,The role of Vitamin E - Selenium - Folic Acid Supplementation in Improving Sperm Parameters After Varicocelectomy: A Randomized Clinical Trial.,"PURPOSE


In this study, we aimed to evaluate the effects of antioxidants including Vitamin E-Selenium-Folic acid (Vit E -Se- FA) on semen parameters following varicocelectomy (VCT).
MATERIALS AND METHODS


Sixty patients from 64 infertile male patients diagnosed with varicocele (VC) who un-derwent sub-inguinal VCT were included in the study. Following sub-inguinal VCT, the patients were randomized into two groups: 30 receiving Vit E-Se-FA supplementation for six months, and 30 as the control group with supplemental treatment. The post-operative semen parameters of Vit E-Se-FA receiving group were compared with control group at the end of experiment. The sperm count, percentage of motile and abnormal sperms were considered.
RESULTS


There were statistically significant differences in terms of count (P = .031) and motility (P = .01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
CONCLUSION


Vit E-Se-FA supplementation can improve sperm parameters (count and motility of sperm) after VCT.",2019,"There were statistically significant increasing in terms of count (P=.031) and motility (P=.01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
",['Sixty from 64 infertile male patients diagnosed with varicocele (VC) and underwent sub-inguinal VCT were included in the study'],"['varicocelectomy (VCT', '30 receiving Vit E-Se-FA supplementation', 'Vit E-Se-FA', 'antioxidants including Vitamin E-Selenium-Folic acid (Vit E -Se- FA', 'Vit E-Se-FA supplementation', 'varicocelectomy', 'Vitamin E - Selenium - Folic acid supplementation']","['sperm parameters (count and motility of sperm', 'count (P=.031) and motility', 'sperm count, percentage of motile and abnormal sperms']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0194985', 'cui_str': 'Excision of varicocele (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}]","[{'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0037842', 'cui_str': 'Sperm Count'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}]",64.0,0.0280862,"There were statistically significant increasing in terms of count (P=.031) and motility (P=.01) of sperm after six months of receiving Vit E-Se-FA supplementation comparing with control group.
","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ardestani Zadeh', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. ardestani_a@yahoo.com.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Naim Sadat', 'Initials': 'NS', 'LastName': 'Kia', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Heshmati', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Seyed Nilofar', 'Initials': 'SN', 'LastName': 'Amirkhalili', 'Affiliation': 'Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran.'}]",Urology journal,['10.22037/uj.v0i0.4653']
3488,31829133,Strategies for recruitment in general practice settings: the iSOLVE fall prevention pragmatic cluster randomised controlled trial.,"BACKGROUND


Falls are common among older people, and General Practitioners (GPs) could play an important role in implementing strategies to manage fall risk. Despite this, fall prevention is not a routine activity in general practice settings. The iSOLVE cluster randomised controlled trial aimed to evaluate implementation of a fall prevention decision tool in general practice. This paper sought to describe the strategies used and reflect on the enablers and barriers relevant to successful recruitment of general practices, GPs and their patients.
METHODS


Recruitment was conducted within the geographical area of a Primary Health Network in Northern Sydney, Australia. General practices and GPs were engaged via online surveys, mailed invitations to participate, educational workshops, practitioner networks and promotional practice visits. Patients 65 years or older were recruited via mailed invitations, incorporating the practice letterhead and the name(s) of participating GP(s). Observations of recruitment strategies, results and enabling factors were recorded in field notes as descriptive and narrative data, and analysed using mixed-methods.
RESULTS


It took 19 months to complete recruitment of 27 general practices, 75 GPs and 560 patients. The multiple strategies used to engage general practices and GPs were collectively useful in reaching the targeted sample size. Practice visits were valuable in engaging GPs and staff, establishing interest in fall prevention and commitment to the trial. A mix of small, medium and large practices were recruited. While some were recruited as a whole-practice, other practices had few or half of the number of GPs recruited. The importance of preventing falls in older patients, simplicity of research design, provision of resources and logistic facilitation of patient recruitment appealed to GPs. Recruitment of older patients was successfully achieved by mailed invitations which was a strategy that was familiar to practice staff and patients. Patient response rates were above the expected 10% for most practices. Many practices (n = 17) achieved the targeted number of 20 or more patients.
CONCLUSIONS


Recruitment in general practice settings can be successfully achieved through multiple recruitment strategies, effective communication and rapport building, ensuring research topic and design suit general practice needs, and using familiar communication strategies to engage patients.
TRIAL REGISTRATION


The trial was prospectively registered on 29 April 2015 with the Australian New Zealand Clinical Trial Registry www.anzctr.org.au (trial ID: ACTRN12615000401550).",2019,Patient response rates were above the expected 10% for most practices.,"['Patients 65', 'older patients', 'Recruitment was conducted within the geographical area of a Primary Health Network in Northern Sydney, Australia', 'years or older were recruited via mailed invitations, incorporating the practice letterhead and the name(s) of participating GP(s', 'older people, and General Practitioners (GPs', 'general practice', '29 April 2015 with the Australian New Zealand Clinical Trial Registry']",['www.anzctr.org.au'],['Patient response rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",27.0,0.200857,Patient response rates were above the expected 10% for most practices.,"[{'ForeName': 'Amy C W', 'Initials': 'ACW', 'LastName': 'Tan', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, New South Wales, Australia. lindy.clemson@sydney.edu.au.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Mackenzie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Constance D', 'Initials': 'CD', 'LastName': 'Pond', 'Affiliation': 'School of Medicine & Public Health (General Practice), University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'White', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Simpson', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}]",BMC medical research methodology,['10.1186/s12874-019-0869-7']
3489,25923150,Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.,"PURPOSE


To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic.
MATERIALS AND METHODS


One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs.
RESULTS


Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim.
CONCLUSION


The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.",2015,Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75).,"['acute renal colic', 'One hundred patients with acute renal colic', 'Patients with low initial pain score']","['intramuscular diclofenac', 'pentazocine 30 mg with promethazine', 'placebo', 'sublingual piroxicam 40 mg and intramuscular distilled water', 'diclofenac and piroxicam', 'sublingual piroxicam', 'intramuscular diclofenac and sublingual methylcobalamin', 'diclofenac']","['pain', 'pain and pain relief', 'complete pain relief', 'Average pain duration', 'severity of pain and pain relief', 'Significant pain relief', 'additional pain relief', 'initial pain relief', 'Visual Analog Scale (VAS) and verbal and facial response scales', 'Pain severity']","[{'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0030873', 'cui_str': 'Pentazocine'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0065844', 'cui_str': 'methylcobalamin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}]",100.0,0.0822738,Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75).,"[{'ForeName': 'Gokul Vignesh', 'Initials': 'GV', 'LastName': 'KandaSwamy', 'Affiliation': 'Dudley Group Hospitals NHS Foundation Trust, Dudley-DY1 2HQ, West Midlands, UK. kgvignesh@yahoo.com.'}, {'ForeName': 'Ananda Kumar', 'Initials': 'AK', 'LastName': 'Dhanasekaran', 'Affiliation': 'Queen Elizabeth University Hospital, Birmingham, UK.'}, {'ForeName': 'Aravindhan', 'Initials': 'A', 'LastName': 'Elangovan', 'Affiliation': 'Dharan Hospital, Salem, India.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Department of Urology Malankara Orthodox Syrian Church Medical College, Kolenchery, India.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'Viswaroop', 'Affiliation': 'Vedanayagam Hospital Private Limited, Coimbatore, India.'}, {'ForeName': 'Kandasami Sangam', 'Initials': 'KS', 'LastName': 'Vedanayagam', 'Affiliation': 'Department of Urology Vedanayagam Hospital, Private Limited, Coimbatore, India.'}]",Urology journal,[]
3490,31470769,Examining Potential Psychosocial Mediators in a Physical Activity Intervention for Older Adults.,"The purpose of this study was to examine psychosocial constructs targeted as potential mediators in a prior physical activity (PA) intervention study. This secondary analysis used data from 102 older adults randomized to one of four conditions-within a 2 (Interpersonal Strategies: yes, no) x 2 (Intrapersonal Strategies: yes, no) factorial design. We tested intervention effects on social support, self-efficacy, self-regulation, and goal attainment, and whether these constructs mediated intervention effects on PA. Participants who received interventions with interpersonal strategies, compared to those who did not, increased their readiness (post-intervention), the self-regulation subscale of self-assessment, and goal attainment (post-intervention, 6-months). Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention). There was no statistically significant mediation. To understand mechanisms through which interventions increase older adults' PA and to improve intervention effectiveness, researchers should continue to examine potential psychosocial mediators.Clinical Trial Registry: NCT02433249.",2020,"Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention).","['Older Adults', '102 older adults randomized to one of four conditions-within a 2 (Interpersonal Strategies: yes, no']",['Physical Activity Intervention'],"['social support, self-efficacy, self-regulation, and goal attainment']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0182743,"Participants who received interventions with intrapersonal strategies, compared to those who did not, increased their social support from family (post-intervention).","[{'ForeName': 'Siobhan K', 'Initials': 'SK', 'LastName': 'McMahon', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jean F', 'Initials': 'JF', 'LastName': 'Wyman', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Division of Biostatistics, School of Public Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rothman', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}]",Western journal of nursing research,['10.1177/0193945919871697']
3491,31514562,Effects of Balanced Ultrafiltration During Extracorporeal Circulation for Children with Congenital Heart Disease on Postoperative Serum Inflammatory Response.,"Objectives:  We studied inflammatory marker changes with ultrafiltration extracorporeal techniques and compared these levels to those occurring during conventional techniques.  Methods:  Seventy-four children undergoing extracorporeal circulation during congenital heart surgery were divided into two groups-conventional (control) and balanced ultrafiltrations (study). Serum interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and soluble intercellular adhesion molecule-1 (sICAM-1), static lung compliance (Cstat), alveolar-arterial oxygen partial pressure difference (A-aDO2), and oxygenation index (OI) were measured.  Results:  Thirty minutes after extracorporeal circulation (T1), IL-6 and TNF-α levels significantly increased ( p  < .05), which plummeted 3 h after surgery (T2). The levels in the study group were lower ( p  < .05). sICAM-1 levels at T1 and T2 significantly exceeded those at T0, and study group had lower levels ( p  < .05). At T1, Cstat and OI dropped ( p  < .05), which increased at T2 ( p  < .05), and study group had less decreases ( p  < .05). A-aDO2 at T1 surpassed that before intervention ( p  < .05), and study group had less increase ( p  < .05).  Conclusion:  Balanced ultrafiltration exerts protective effects on children with congenital heart disease undergoing extracorporeal circulation.",2020,"At T1, Cstat and OI dropped ( p  < .05), which increased at T2 ( p  < .05), and study group had less decreases ( p  < .05).","['children with congenital heart disease undergoing extracorporeal circulation', 'Methods:  Seventy-four children undergoing extracorporeal circulation during congenital heart surgery', 'Children with Congenital Heart Disease on Postoperative Serum Inflammatory Response']","['Balanced ultrafiltration', 'Balanced Ultrafiltration', 'ultrafiltration extracorporeal techniques']","['Serum interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and soluble intercellular adhesion molecule-1 (sICAM-1), static lung compliance (Cstat), alveolar-arterial oxygen partial pressure difference (A-aDO2), and oxygenation index (OI', 'sICAM-1 levels', 'extracorporeal circulation (T1), IL-6 and TNF-α levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C2959649', 'cui_str': 'Extracorporeal technique'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal Circulation'}]",74.0,0.0218037,"At T1, Cstat and OI dropped ( p  < .05), which increased at T2 ( p  < .05), and study group had less decreases ( p  < .05).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiovascular Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Outpatient Department, Nanjing Tongren Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Peicheng', 'Initials': 'P', 'LastName': 'Ding', 'Affiliation': ""Department of Cardiovascular Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Kaihong', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiovascular Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Xuming', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': ""Department of Cardiovascular Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.""}]",Fetal and pediatric pathology,['10.1080/15513815.2019.1661050']
3492,31343945,Aortic diastolic pressure decay modulates relation between worsened aortic stiffness and myocardial oxygen supply/demand balance after resistance exercise.,"High-intensity resistance exercise (RE) increases aortic stiffness and decreases the index of myocardial oxygen supply/demand balance (Buckberg index, BI); there is a correlation between the changes in these parameters. Central hemodynamics during diastole can explain the correlation. We aimed to investigate whether the aortic diastolic decay index mediates the association between changes in aortic stiffness and BI by high-intensity RE. We evaluated the effect of high-intensity RE on aortic stiffness, BI, aortic decay index, and their associations in 52 young men. Subjects were studied under parallel experimental conditions on two separate days. The order of experiments was randomized between RE (5 sets of 10 repetitions at 75% of 1-repetition maximum) and sham control (seated rest). Aortic pulse wave velocity (PWV; index of aortic stiffness), BI, and aortic decay index were measured in all subjects. Aortic decay index was quantified by fitting an exponential curve: P( t ) = P 0 e -λ t  (where λ is decay index, P 0  is end-systolic pressure and  t  is time from end-systole). Aortic PWV and decay index increased and BI decreased after RE. RE conditions showed that change in the aortic decay index was associated with changes in aortic PWV and changes in aortic PWV were related to changes in BI, although the PWV-BI relationship was not significant after accounting for decay index change. Mediation analysis revealed the mediating effect of the aortic decay index on the relationship between changes in aortic PWV and BI. The present findings suggest that high-intensity RE-induced aortic stiffening worsens myocardial viability by accelerating aortic diastolic exponential decay. NEW & NOTEWORTHY  Aortic pulse wave velocity (PWV) and diastolic decay index increased and Buckberg index (BI) decreased after resistance exercise (RE). Mediation analysis revealed a mediating effect of aortic decay index on the relationship between changes in aortic PWV and BI. The present study provides evidence that high-intensity RE-induced aortic stiffening accelerates aortic decay and aortic decay can account for the relationship between aortic stiffening and a deteriorated surrogate marker of myocardial oxygen supply/demand balance induced by high-intensity RE.",2019,Aortic PWV and decay index increased and BI decreased after RE.,['52 young men'],"['high-intensity RE', 'High-intensity resistance exercise (RE']","['Aortic PWV and decay index increased and BI', 'aortic stiffness, BI, aortic decay index', 'aortic decay index', 'aortic stiffness and decreases index of myocardial oxygen supply/demand balance (Buckberg index, BI', 'aortic PWV, and changes in aortic PWV', 'Aortic pulse wave velocity (PWV; index of aortic stiffness), BI, and aortic decay index', 'Aortic decay index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",52.0,0.0185146,Aortic PWV and decay index increased and BI decreased after RE.,"[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Tagawa', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Akari', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Atsumu', 'Initials': 'A', 'LastName': 'Yokota', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00117.2019']
3493,30686102,Balance problems and dizziness after neck surgery - associations with pain and health-related quality of life.,"Introduction : Symptoms of dizziness or imbalance are often present in individuals with a variety of neck-disorders. The aims of this study were to determine the prevalence of patient-reported balance problems and dizziness 10-13 years after surgery for cervical degenerative disc disease; evaluate associations with neck pain and health-related quality of life; and investigate how these individuals described dizziness.  Material and methods : Sixty-eight individuals, 10 years or more after anterior cervical decompression and fusion surgery, who previously participated in a randomized controlled trial were included. Participants completed questionnaires including ratings of dizziness and balance problems, the Dizziness Handicap Inventory, and an open-ended question regarding their experience of dizziness. Secondary outcomes were neck pain and quality of life.  Results : Seventy-two percent experienced occasional or daily symptoms of unsteadiness and/or dizziness. Intensity ratings for dizziness during movement and for balance problems were similar and rather low, but had an impact on quality of life. Ratings of dizziness at rest were even lower. Dizziness ratings were associated with neck pain. Strenuous activities were related to dizziness and dizziness was primarily described as intermittent and non-rotatory.  Conclusions : Dizziness or balance problems in the long-term after surgery for cervical degenerative disc disease are common and have an impact on daily life. Ratings of problem frequency and intensity were usually low. Dizziness and balance problems may affect quality of life. Patients' descriptions of these problems are in line with common symptoms of cervicogenic dizziness.",2020,"Intensity ratings for dizziness during movement and for balance problems were similar and rather low, but had an impact on quality of life.","['individuals with a variety of neck-disorders', 'Sixty-eight individuals, 10\xa0years or more after anterior cervical decompression and fusion surgery, who previously participated in a randomized controlled trial were included', 'patient-reported balance problems and dizziness 10-13\xa0years after surgery for cervical degenerative disc disease']",[],"['dizziness and dizziness', 'Balance problems and dizziness', 'occasional or daily symptoms of unsteadiness and/or dizziness', 'Ratings of dizziness', 'ratings of dizziness and balance problems, the Dizziness Handicap Inventory, and an open-ended question regarding their experience of dizziness', 'Dizziness ratings', 'quality of life', 'Intensity ratings for dizziness', 'neck pain and quality of life']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0158266', 'cui_str': 'Disc Degradation'}]",[],"[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0427108', 'cui_str': 'General unsteadiness (finding)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0034380'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]",,0.0958745,"Intensity ratings for dizziness during movement and for balance problems were similar and rather low, but had an impact on quality of life.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hermansen', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Hedlund', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofi', 'Initials': 'AS', 'LastName': 'Kammerlind', 'Affiliation': 'Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University , Linköping, Sweden.'}]",Physiotherapy theory and practice,['10.1080/09593985.2019.1571137']
3494,30852728,Effects of a Mobile Health Intervention to Promote HIV Self-testing with MSM in China: A Randomized Controlled Trial.,"This study tested a mobile health (mHealth) intervention program entitled WeTest, delivered via the WeChat mobile app, to promote oral HIV self-testing (HIVST) among MSM in Hefei, China. A total of 100 MSM participants enrolled, completed baseline assessment, were randomly assigned to intervention or control, and completed 6-month follow-up surveys. Intervention participants (n = 50) received two oral HIVST kits and access to WeTest, a private WeChat group which provided app-based messages and referrals to health services related to HIV. Control participants (n = 50) received two oral HIVST kits only. All participants received instructions to upload photographic results of their oral HIVST, which were sent to the project counselor via a secure WeChat online portal; immediate contact and referrals were made to any participants who tested HIV-positive. In GEE analyses adjusting for time effects and baseline confounders, intervention participants had significantly higher rates of HIV testing (adjusted rate ratio RR = 1.99, 95% confidence interval (CI) 1.07-3.84) and, in particular, higher rates of testing via oral HIVST (adjusted RR = 2.17, 95% CI 1.08-4.37) compared with the control group. Significant time effects were also found such that all participants, regardless of group allocation, had significantly higher rates of reporting consistent condom use with main partners (adjusted RR = 18.13, 95% CI 5.19-63.31) and with non-main partners (adjusted RR = 5.33, 95% CI 2.35-12.08). Findings from this study provide evidence for the feasibility, acceptability and preliminary effects of this mHealth approach to promoting oral HIVST among MSM in China.",2019,"Significant time effects were also found such that all participants, regardless of group allocation, had significantly higher rates of reporting consistent condom use with main partners (adjusted RR = 18.13, 95% CI 5.19-63.31) and with non-main partners (adjusted RR = 5.33, 95% CI 2.35-12.08).","['HIV Self-testing with MSM in China', '100 MSM participants enrolled, completed baseline assessment', 'Intervention participants (n\u2009=\u200950']","['Mobile Health Intervention', 'instructions to upload photographic results of their oral HIVST, which were sent to the project counselor via a secure WeChat online portal; immediate contact and referrals were made to any participants who tested HIV-positive', 'oral HIVST kits', 'mobile health (mHealth) intervention program entitled WeTest, delivered via the WeChat mobile app, to promote oral HIV self-testing (HIVST', 'oral HIVST kits and access to WeTest, a private WeChat group which provided app-based messages and referrals to health services related to HIV']","['rates of HIV testing', 'rates of testing via oral HIVST']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",100.0,0.404839,"Significant time effects were also found such that all participants, regardless of group allocation, had significantly higher rates of reporting consistent condom use with main partners (adjusted RR = 18.13, 95% CI 5.19-63.31) and with non-main partners (adjusted RR = 5.33, 95% CI 2.35-12.08).","[{'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Wenhan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA. don_operario@brown.edu.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Anxia', 'Initials': 'A', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 South Main Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Nickolas', 'Initials': 'N', 'LastName': 'Zaller', 'Affiliation': 'Department of Health Behavior and Health Education, University of Arkansas Fay W. Boozman College of Public Health, Little Rock, AR, USA.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Yehuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health, Anhui Medical University, 81 Meishan Road, Hefei, China. zhanghongbo@ahmu.edu.cn.'}]",AIDS and behavior,['10.1007/s10461-019-02452-5']
3495,30602433,"The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial.","BACKGROUND


Young gay, bisexual, and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the United States. Substantial evidence indicates that up to two-thirds of new HIV infections occur in the context of a main partnership. Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan.
OBJECTIVE


This study aims to develop and test a relationship skills-focused HIV prevention intervention for YMSM and their partners. The intervention consists of two telehealth-delivered sessions: the first focuses on relationship skills and the second consists of CHTC and prevention planning. Both sessions are attended by both members of the dyad.
METHODS


This protocol describes the development of the proposed intervention (We Prevent) and pilot test to examine its feasibility and preliminary efficacy. The intervention will include two motivational interviewing-based sessions: session one is a relationship skills-building session, focused on techniques to explore and build communication skills in a relationship, to help YMSM develop and enhance necessary skills for their current and future relationships; the second session is a CHTC session with YMSM and their partners, to help them develop an HIV prevention plan. Through qualitative data collection and a one-arm pilot with YMSM, we will develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention. We will then conduct a pilot randomized controlled trial (RCT), comparing the acceptability, feasibility, and preliminary efficacy of the adapted two-session telehealth intervention for YMSM versus a control group receiving one session only-a CHTC session delivered via telehealth.
RESULTS


The We Prevent intervention is designed to increase uptake of HIV prevention, shown through self-reported reductions in condomless sex and increases in knowledge and uptake of pre-exposure prophylaxis. In addition, the intervention is designed to increase HIV and sexually transmitted infection (STI) testing. STI incidence is examined as a secondary outcome. A cost-input analysis will examine the costs associated with intervention delivery to inform future scale-up of the intervention.
CONCLUSIONS


Drawing on theory and existing CHTC protocols delivered with video-based counseling, this proposed intervention affords the opportunity to empower YMSM with the skills necessary to communicate with their partners and protect themselves from HIV in their current and future relationships.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03551938; https://clinicaltrials.gov/ct2/show/NCT03551938 (Archived by WebCite at http://www.webcitation.org/73omJCz1a).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/10370.",2019,"Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan.
","['Young gay, bisexual, and other men who have sex with men (YMSM', 'male couples', 'Who Have Sex With Men and Their Primary Partners (We Prevent', 'Young Gay, Bisexual, and Other Men']","['YMSM', 'CHTC and prevention planning', 'HIV prevention intervention', 'Couples HIV testing and counseling (CHTC', 'Relationship Skills Intervention']",['HIV Prevention Uptake'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C0768887', 'cui_str': 'ChtC'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",2.0,0.0561506,"Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan.
","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Gamarel', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Lynae A', 'Initials': 'LA', 'LastName': 'Darbes', 'Affiliation': 'Center for Sexuality and Health Disparities, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Center for Sexuality and Health Disparities, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/10370']
3496,31650077,Suubi4Cancer: A protocol for an innovative combination intervention to improve access to pediatric cancer services and treatment adherence among children living with HIV/AIDS in Uganda.,"Youth Living with HIV  (YLWHIV) are at high risk for cancer. Sub-Saharan Africa (SSA) has some of the worst pediatric cancer survival rates due to barriers to accessing cancer services and treatment adherence. This protocol describes a study that aims at: 1)  Identifying confirmed and suspected cancer cases in a cohort of >3000 HIV positive youth;  2)  Examining the short-term preliminary outcomes of an evidence-based Economic Empowerment (EE) intervention , Suubi (""hope"" in a local Ugandan language), on access to pediatric cancer diagnosis and care, and treatment adherence among YLWHIV with suspected cancers in Uganda; and 3)  Exploring multi-level factors impacting intervention participation and experiences.  The proposed Suubi4Cancer intervention combines savings-led EE through family development accounts (FDA) with financial literacy and management (FLM) and cancer education (CE). The study will review medical charts in 39 clinics in Southwest Uganda to identify confirmed and suspected cancer cases. Subsequently, Suubi4Cancer will be evaluated via a randomized-controlled trial design (FDA + FLM + CE versus Usual Care) targeting a total of 78 youth ages 10-to-24 and their caregivers. Assessments at baseline and 9 months will examine change in cancer treatment access; cancer treatment adherence; and knowledge, attitudes, and beliefs about cancer and cancer treatment. Semi-structured interviews with the intervention group will explore their intervention experiences. To our knowledge, Suubi4Cancer will be the first study to test the preliminary impact and acceptability of a combination intervention to increase access to cancer diagnosis and treatment services for YLWHIV.
Trial registration


Clinical Trials NCT03916783 (Registered: 04/16/19).",2019,Sub-Saharan Africa (SSA) has some of the worst pediatric cancer survival rates due to barriers to accessing cancer services and treatment adherence.,"['Youth Living with HIV  (YLWHIV', '39 clinics in Southwest Uganda to identify confirmed and suspected cancer cases', 'children living with HIV/AIDS in Uganda', 'suspected cancer cases in a cohort of >3000 HIV positive youth', '78 youth ages 10-to-24 and their caregivers']","['evidence-based Economic Empowerment (EE) intervention , Suubi (""hope"" in a local Ugandan language', 'Sub-Saharan Africa (SSA', 'Suubi4Cancer']","['knowledge, attitudes, and beliefs about cancer and cancer treatment']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0581833', 'cui_str': 'Suspected cancer'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",78.0,0.043228,Sub-Saharan Africa (SSA) has some of the worst pediatric cancer survival rates due to barriers to accessing cancer services and treatment adherence.,"[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Brown School at Washington University in St. Louis, St. Louis, USA.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'Brown School at Washington University in St. Louis, St. Louis, USA.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Johnson', 'Affiliation': 'Brown School at Washington University in St. Louis, St. Louis, USA.'}, {'ForeName': 'Ruth G N', 'Initials': 'RGN', 'LastName': 'Katumba', 'Affiliation': 'Brown School at Washington University in St. Louis, St. Louis, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100459']
3497,31492718,Low-dose ladostigil for mild cognitive impairment: A phase 2 placebo-controlled clinical trial.,"OBJECTIVE


Ladostigil reduces oxidative stress and microglial activation in aging rats. We assessed its safety and potential efficacy in a 3-year, randomized, double-blind, placebo-controlled phase 2 clinical trial in patients with mild cognitive impairment (MCI) and medial temporal lobe atrophy.
METHODS


Patients 55 to 85 years of age with MCI, Clinical Dementia Rating (CDR) score of 0.5, Mini-Mental State Examination (MMSE) score >24, Wechsler Memory Scale-Revised Verbal Paired Associates I score ≤18, and Medial Temporal Lobe Atrophy Scale score >1 were stratified by  APOE  ε4 genotype and randomly assigned (1:1) to ladostigil 10 mg/d or placebo. Primary outcomes were safety and onset of Alzheimer disease dementia. Secondary endpoints were Neuropsychological Test Battery (NTB) composite, Disability Assessment in Dementia (DAD), and Geriatric Depression Scale (GDS) scores. Exploratory outcomes were NTB component, CDR, and MMSE scores. Biomarkers included MRI-derived whole-brain, hippocampus, and entorhinal cortex volumes.
RESULTS


Two hundred ten patients from 15 sites in Austria, Germany, and Israel were randomly allocated to placebo (107 patients) or ladostigil (103 patients). After 36 months, 21 of 103 patients on placebo and 14 of 99 patients receiving ladostigil progressed to Alzheimer disease (log-rank test  p  = 0.162). There were no significant effects on the NTB composite, DAD, or GDS score. Whole-brain and hippocampus volumes decreased more in the placebo than in the ladostigil group (whole brain,  p  = 0.025, Cohen d = 0.43; hippocampus,  p  = 0.043, d = 0.43). Serious adverse events were reported by 28 of 107 patients treated with placebo and 26 of 103 with ladostigil.
CONCLUSION


Ladostigil was safe and well tolerated but did not delay progression to dementia. Its association with reduced brain and hippocampus volume loss suggests a potential effect on atrophy.
CLINICALTRIALSGOV IDENTIFIER


NCT01429623.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with MCI and medial temporal lobe atrophy, ladostigil did not significantly decrease the risk of the development of Alzheimer disease.",2019,"Whole-brain and hippocampus volumes decreased more in the placebo than in the ladostigil group (whole brain,  ","['Patients 55 to 85 years of age with MCI, Clinical Dementia Rating (CDR) score of 0.5, Mini-Mental State Examination (MMSE) score', 'aging rats', '107 patients) or ladostigil (103 patients', 'patients with mild cognitive impairment (MCI) and medial temporal lobe atrophy', 'Two hundred ten patients from 15 sites in Austria, Germany, and Israel', 'mild cognitive impairment']","['placebo', 'Low-dose ladostigil', 'ladostigil 10 mg/d or placebo']","['24, Wechsler Memory Scale-Revised Verbal Paired Associates', 'Medial Temporal Lobe Atrophy Scale score', 'NTB component, CDR, and MMSE scores', 'NTB composite, DAD, or GDS score', 'safety and potential efficacy', 'Neuropsychological Test Battery (NTB) composite, Disability Assessment in Dementia (DAD), and Geriatric Depression Scale (GDS) scores', 'Whole-brain and hippocampus volumes', 'Serious adverse events', 'safe and well tolerated', 'oxidative stress and microglial activation', 'safety and onset of Alzheimer disease dementia', 'ladostigil progressed to Alzheimer disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C4304227', 'cui_str': 'Clinical Dementia Rating score'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1609818', 'cui_str': 'Ladostigil'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1609818', 'cui_str': 'Ladostigil'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0222045'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1609818', 'cui_str': 'Ladostigil'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]",210.0,0.596703,"Whole-brain and hippocampus volumes decreased more in the placebo than in the ladostigil group (whole brain,  ","[{'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel. lschneid@usc.edu.'}, {'ForeName': 'Yona', 'Initials': 'Y', 'LastName': 'Geffen', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rabinowitz', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Thomas', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ropele', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Weinstock', 'Affiliation': 'From the Keck School of Medicine of the University of Southern California (L.S.S.), Los Angeles; Avraham Pharmaceuticals, Ltd (Y.G.), Yavne; Bar Ilan University (J.R.), Ramat Gan, Israel; University of California (R.G.T.), San Diego; Department of Neurology (R.S., S.R.), Medical University, Graz, Austria; and Hebrew University (M.W.), Jerusalem, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000008239']
3498,29572695,The effect of swim-up and gradient sperm preparation techniques on deoxyribonucleic acid (DNA) fragmentation in subfertile patients.,"PURPOSE


To compare the effect of two different sperm preparation techniques, including swim-up and gradient methods on sperm deoxyribonucleic acid (DNA) fragmentation status of semen samples from unexplained and mild male factor subfertile patients undergoing intrauterine insemination (IUI).
DESIGN


A prospective randomized study was conducted in 65 subfertile patients, including 34 unexplained and 31 male factor infertility to compare basal and post-procedure DNA fragmentation rates in swim-up and gradient techniques. Sperm DNA fragmentation rates were evaluated by a sperm chromatin dispersion (SCD) test in two portions of each sample of semen that was prepared with either swim-up or gradient techniques. Sperm motility and morphology were also assessed based on WHO 2010 criteria.
RESULTS


Swim-up but not gradient method yielded a statistically significant reduction in the DNA fragmented sperm rate after preparation as compared to basal rates, in the semen samples of both unexplained (41.85 ± 22.04 vs. 28.58 ± 21.93, p < 0.001 for swim-up; and 41.85 ± 22.04 vs. 38.79 ± 22.30, p = 0.160 for gradient) and mild male factor (46.61 ± 19.38 vs. 30.32 ± 18.20, p < 0.001 for swim-up and 46.61 ± 19.38 vs. 44.03 ± 20.87, p = 0.470 for gradient) subgroups.
CONCLUSIONS


Swim-up method significantly reduces sperm DNA fragmentation rates and may have some prognostic value on intrauterine insemination in patients with decreased sperm DNA integrity.",2018,Swim-up method significantly reduces sperm DNA fragmentation rates and may have some prognostic value on intrauterine insemination in patients with decreased sperm DNA integrity.,"['unexplained and mild male factor subfertile patients undergoing intrauterine insemination (IUI', '65 subfertile patients, including 34 unexplained and 31 male factor infertility to compare basal and post-procedure DNA fragmentation rates in swim-up and gradient techniques', 'subfertile patients']",['swim-up and gradient sperm preparation techniques'],"['DNA fragmented sperm rate', 'sperm DNA fragmentation rates', 'deoxyribonucleic acid (DNA) fragmentation', 'Sperm DNA fragmentation rates', 'Sperm motility and morphology']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0037848', 'cui_str': 'Sperm Motility'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",65.0,0.0806658,Swim-up method significantly reduces sperm DNA fragmentation rates and may have some prognostic value on intrauterine insemination in patients with decreased sperm DNA integrity.,"[{'ForeName': 'Yuksel', 'Initials': 'Y', 'LastName': 'Oguz', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Guler', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey. driguler@yahoo.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey.'}, {'ForeName': 'Mehmet Firat', 'Initials': 'MF', 'LastName': 'Mutlu', 'Affiliation': 'Department of Obstetrics and Gynecology, Yuksek Ihtisas University, Ankara, Turkey.'}, {'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Gumuslu', 'Affiliation': 'IVF Unit, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Oktem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, 06500, Besevler, Ankara, Turkey.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-018-1163-z']
3499,30648920,The Effects of a Mobile Wellness Intervention with Fitbit Use and Goal Setting for Workers.,"Background and Introduction:  There is strong evidence that worksite wellness programs can significantly improve the health profile of participating workers. To date, little is known about research on the effects of mobile wellness interventions in worksite settings. Furthermore, no studies have been conducted to evaluate mobile wellness interventions with activity trackers and tailoring strategies for physically inactive workers in manufacturing companies. This study aimed to examine the effects of a mobile wellness intervention with Fitbit and goal setting using brief counseling and text messaging among workers.   Materials and Methods:  A total of 79 (n = 79) workers from large manufacturing companies were allocated into an experimental group (n = 41) and a control group (n = 38). All participants were asked to wear an activity tracker (Fitbit Charger HR) during all waking hours for 5 weekdays. Participants in the experimental group received Fitbit, daily motivational text messaging, and biweekly counseling with a specifically designed workbook for 12 weeks, whereas Fitbit was only provided to the control group.   Results:  At the 12-week measurement, there were significant differences between the experimental group and control group on wellness (p < 0.001), physical activity behavior (p < 0.001), daily walking steps (p < 0.001), and physical activity self-efficacy (p < 0.001).   Discussion and Conclusions:  Although Fitbit facilitates an individual's activities by providing information about daily steps, the tracker itself, without additional goal-setting techniques, may be insufficient to encourage behavior change. These findings indicate that the mobile wellness intervention with Fitbit and goal setting using brief counseling and tailored text messaging is more effective for physically inactive workers.",2019,"At the 12-week measurement, there were significant differences between the experimental group and control group on wellness (p < 0.001), physical activity behavior (p < 0.001), daily walking steps (p < 0.001), and physical activity self-efficacy (p < 0.001).
","['Workers', 'A total of 79 (n\u2009=\u200979) workers from large manufacturing companies', 'physically inactive workers in manufacturing companies', 'workers']","['Mobile Wellness Intervention', ' and Introduction', 'mobile wellness intervention', 'Fitbit, daily motivational text messaging, and biweekly counseling with a specifically designed workbook']","['physical activity self-efficacy', 'daily walking steps', 'physical activity behavior', 'activity tracker (Fitbit Charger HR']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",79.0,0.043813,"At the 12-week measurement, there were significant differences between the experimental group and control group on wellness (p < 0.001), physical activity behavior (p < 0.001), daily walking steps (p < 0.001), and physical activity self-efficacy (p < 0.001).
","[{'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Convergence Research Center for Wellness, Daegu Gyeonbuk Institute of Science and Technology (DGIST), Daegu, South Korea.'}, {'ForeName': 'Yeongmi', 'Initials': 'Y', 'LastName': 'Ha', 'Affiliation': 'College of Nursing and Institute of Health Sciences, Gyeongsang National University, Jinju, South Korea.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Department of Nursing, Hanyeong College, Yeosu, South Korea.'}, {'ForeName': 'Seungkyoung', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, Kyungnam University, Changwon, South Korea.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kang', 'Affiliation': 'Convergence Research Center for Wellness, Daegu Gyeonbuk Institute of Science and Technology (DGIST), Daegu, South Korea.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0185']
3500,31219698,Randomized Trial of a Single-Session Growth Mind-Set Intervention for Rural Adolescents' Internalizing and Externalizing Problems.,"Adolescents living in rural regions of the United States face substantial barriers to accessing mental health services, creating needs for more accessible, nonstigmatizing, briefer interventions. Research suggests that single-session ""growth mind-set"" interventions (GM-SSIs)-which teach the belief that personal traits are malleable through effort-may reduce internalizing and externalizing problems in adolescents. However, GM-SSIs have not been evaluated among rural youth, and their effects on internalizing and externalizing problems have not been assessed within a single trial, rendering their relative benefits for different problem types unclear. We examined whether a computerized GM-SSI could reduce depressive symptoms, social anxiety symptoms, and conduct problems in female adolescents from rural areas of the United States. Tenth-grade female adolescents ( N  = 222,  M  age = 15.2, 38% White, 25% Black, 29% Hispanic) from 4 rural, low-income high schools in the southeastern United States were randomized to receive a 45-min GM-SSI or a computer-based active control program, teaching healthy sexual behaviors. Young women self-reported depression symptoms, social anxiety symptoms, and conduct problem behaviors at baseline and 4-month follow-up. Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d = .23) and likelihood of reporting elevated depressive symptoms ( d = .29) from baseline to follow-up. GM-SSI effects were nonsignificant for social anxiety symptoms, although a small effect size emerged in the hypothesized direction ( d = .21), and nonsignificant for change in conduct problems ( d = .01). A free-of-charge 45-min GM-SSI may help reduce internalizing distress, especially depression-but not conduct problems-in rural female adolescents.",2020,"Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d  = .23) and likelihood of reporting elevated depressive symptoms ( d  = .29) from baseline to follow-up.","[""Rural Adolescents' Internalizing and Externalizing Problems"", 'adolescents', '15.2, 38% White, 25% Black, 29% Hispanic) from 4 rural, low-income high schools in the southeastern United States', 'rural female adolescents', 'Tenth-grade female adolescents ( N  =\xa0222,  M  age\xa0', 'Adolescents living in rural regions', 'female adolescents from rural areas of the United States']","['45-min GM-SSI or a computer-based active control program', 'Single-Session Growth Mind-Set Intervention', 'computerized GM-SSI']","['depressive symptoms, social anxiety symptoms', 'depression symptoms, social anxiety symptoms, and conduct problem behaviors', 'depressive symptoms', 'social anxiety symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",,0.138163,"Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d  = .23) and likelihood of reporting elevated depressive symptoms ( d  = .29) from baseline to follow-up.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Department of Psychology, Stony Brook University.'}, {'ForeName': 'Jeni L', 'Initials': 'JL', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Widman', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Hoyt', 'Affiliation': 'Jepson School of Leadership Studies, University of Richmond.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Prinstein', 'Affiliation': 'Department of Psychology, University of North Carolina-Chapel Hill.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1622123']
3501,31102525,Visit-to-visit variability in blood pressure and the development of chronic kidney disease in treated general hypertensive patients.,"BACKGROUND


Data on the association between visit-to-visit variability (VVV) in blood pressure (BP) and the risk of chronic kidney disease (CKD) in general treated hypertensive patients were limited. We aimed to evaluate the relation of VVV in BP with the development of CKD, and examine any possible effect modifiers in hypertensive patients without prior cardiovascular diseases (CVDs) or CKD.
METHODS


This is a post hoc analysis of the Renal Sub-study of the China Stroke Primary Prevention Trial (CSPPT). A total of 10 051 hypertensives without CVD and CKD and with at least six visits of BP measurements from randomization to the 24-month visit were included. The main VVV in BP was expressed as standard deviation (SD). The primary outcome was the development of CKD, defined as a decrease in estimated glomerular filtration rate ≥30% and to a level of <60 mL/min/1.73 m2, or end-stage renal disease.
RESULTS


The median treatment duration was 4.4 years. After multivariable adjustment, including baseline systolic blood pressure (SBP) and mean SBP during the first 2-year treatment period, there was a significantly positive relationship of SD of SBP with the risk of CKD development (per SD increment; odds ratio, 1.27; 95% confidence interval: 1.10-1.46). The results were similar for coefficient of variation (CV) of SBP. Results across various subgroups, including age, sex, SBP at baseline, treatment compliance, concomitant antihypertensive medications and mean SBP during the first 24-month treatment period, were consistent.
CONCLUSIONS


SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.",2020,"CONCLUSIONS


SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.","['A total of 10\xa0051 hypertensives without CVD and CKD and with at least six visits of BP measurements from randomization to the 24-month visit were included', 'general treated hypertensive patients', 'treated general hypertensive patients', 'hypertensive patients without prior cardiovascular diseases (CVDs) or CKD']",[],"['coefficient of variation (CV) of SBP', 'SD of SBP with the risk of CKD development', 'baseline systolic blood pressure (SBP) and mean SBP', 'mean BP level', 'blood pressure (BP', 'median treatment duration', 'development of CKD, defined as a decrease in estimated glomerular filtration rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",[],"[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C3811844'}]",10051.0,0.0580914,"CONCLUSIONS


SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.","[{'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, The Key Laboratory for Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guobao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital, Nanchang University, Nanchang, China.'}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lianyou', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qijun', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Nephrology, Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Emergency, First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Junnong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Weinan Central Hospital, Weinan, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, The First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz093']
3502,31150295,Reduction in Suicidal Ideation from Prolonged Exposure Therapy for Adolescents.,"OBJECTIVE


Adolescents with posttraumatic stress disorder (PTSD) are at higher risk for suicide compared to adolescents without PTSD. This study aimed to explore whether PTSD treatment reduces suicidal ideation in adolescents and whether the degree of reduction in PTSD was associated with reduction in suicidal ideation.
METHODS


Adolescent females with PTSD from a sexual assault (55% Black, 15.3 years,  SD  = 1.5) were randomized to either prolonged exposure therapy for adolescents (PE-A,  n = 31) or client-centered therapy (CCT,  n  = 30). They reported on suicidal ideation, depression and PTSD at pre- and post-treatment, every therapy session, and follow-up, and about 40% endorsed suicidal ideation at baseline.
RESULTS


There was a significant reduction in a single-item measure of suicidal ideation during treatment across all participants. The Time in Treatment × Condition interaction was significant ( p  < .05,  d  = 0.52), indicating a significantly steeper reduction in suicidal ideation in PE-A compared to in CCT. The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
CONCLUSIONS


Adolescents randomized to PE-A had significantly faster reductions in suicidal ideation compared to those randomized to CCT. Greater reduction in PTSD and depression symptoms were associated with faster reduction in suicidal ideation. Clinically, this study demonstrates that adolescents who have suicidal ideation without current intent may benefit from PE-A.",2020,"The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d  = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
","['Adolescent females with PTSD from a sexual assault (55% Black, 15.3 years,  SD  = 1.5', 'Adolescents', 'Adolescents with posttraumatic stress disorder (PTSD']","['prolonged exposure therapy for adolescents (PE-A,  n = 31) or client-centered therapy (CCT', 'PTSD']","['suicidal ideation, depression and PTSD', 'single-item measure of suicidal ideation', 'speed of suicidal ideation reduction', 'degree of reduction in PTSD', 'PTSD and depression symptoms', 'depression symptoms', 'suicidal ideation', 'Suicidal Ideation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028302', 'cui_str': 'Nondirective Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0229353,"The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d  = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
","[{'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Belli', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Capaldi', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1614003']
3503,31283365,"Effects of Yoga Versus Sham Yoga on Oxidative Stress, Glycemic Status, and Anthropometry in Type 2 Diabetes Mellitus: A Single-Blinded Randomized Pilot Study.","Studies have shown a beneficial role of yoga in tre a t i n g type 2 diabetes mellitus. The present study proceeds in the field by providing an active control. We aimed to evaluate the effect of 3 months of yoga on oxidative stress, glycemic status, and anthropometry in type 2 diabetes mellitus. Forty participants were randomized to receive either yoga (n = 20) or sham yoga (n = 20) as a control. Yoga included postures and breathing exercises, and nonaerobic stretching exercise comprised the control. Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups. Yoga participants had significantly greater improvement in reduced glutathione compared to controls. No significant differences between groups were observed in any other outcome variables. Yoga and sham yoga had identical effects on oxidative stress, glycemic status, and anthropometry in type 2 diabetes mellitus. Levels of reduced glutathione improved only in the yoga group. This research needs to be confirmed by larger and sufficiently powered studies.",2020,"Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups.","['type 2 diabetes mellitus', 'Type 2 Diabetes Mellitus', 'Forty participants']","['Yoga Versus Sham Yoga', 'yoga ( n  = 20) or sham yoga', 'Yoga and sham yoga', 'Yoga included postures and breathing exercises, and nonaerobic stretching exercise comprised the control']","['Levels of reduced glutathione', 'malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure', 'Oxidative Stress, Glycemic Status, and Anthropometry', 'reduced glutathione', 'oxidative stress, glycemic status, and anthropometry']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",40.0,0.0831909,"Significant within-group differences in malondialdehyde, vitamin C, superoxide dismutase, fasting blood glucose, glycosylated hemoglobin, body mass index, waist circumference, and blood pressure were evident in both groups.","[{'ForeName': 'Shreelaxmi V', 'Initials': 'SV', 'LastName': 'Hegde', 'Affiliation': 'Department of Biochemistry, Srinivas Institute of Medical Science and Research Centre, Mangalore; and Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka, India.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Adhikari', 'Affiliation': 'Department of Geriatric Medicine, Yenepoya Medical College, Yenepoya University, Mangalore, Karnataka, India.'}, {'ForeName': 'Shashidhar M', 'Initials': 'SM', 'LastName': 'Kotian', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore; and Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Shastry', 'Affiliation': 'Department of Pharmacology, Kasturba Medical College, Mangalore; and Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",International journal of yoga therapy,['10.17761/D-18-2020-00018']
3504,31895867,Three-month Storage of Human Corneas in an Active Storage Machine.,"BACKGROUND


Corneal storage for the very long term, without degradation, would make it possible to optimize a very limited resource worldwide. We previously demonstrated the superiority, compared to conventional 4-week passive organ culture (OC), of an active storage machine (ASM) that restores intraocular pressure and medium renewal. Here, we investigate eye banking for up to 3 months.
METHODS


In a randomized preclinical trial with 24 paired corneas, 1 was stored in OC and the other in ASM, using the same medium. Assessments were done on the second day and at 3 months: endothelial cell density (ECD in cells/mm), corneal transparency and thickness. At day 86, OC corneas were deswelled in a common hyperosmotic medium, but not the ASM corneas, which had remained thin. In addition, at day 88, viable ECD was measured using a live/dead assay, and endothelial expression of Na/K ATPase, Cox IV, ZO-1, N-CAM, and CD166 was observed.
RESULTS


The ASM extended storage to 3 months with unprecedented endothelial cell quality: no OC corneas remained suitable for transplantation, but one-third of ASM corneas were compliant (ECD > 2000/mm). Given that corneas with ECD > 1600/mm were also usable for emergency, 58% of ASM corneas were usable versus 33% in OC. EC survival was 53% higher in ASM (P < 0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
CONCLUSIONS


By extending graft survival to 3 months, the ASM will optimize eye banking and open up new perspectives in experimental research.",2020,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
",[],"['conventional 4-week passive organ culture (OC), of an active storage machine (ASM']","['live/dead assay, and endothelial expression of Na/KATPase, Cox-IV, ZO-1, N-CAM and CD166', 'endothelial cell density (ECD in cells/mm), corneal transparency and thickness', 'EC survival']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture Techniques'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0431232,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
","[{'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Garcin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Gauthier', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Crouzet', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Herbepin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Perrache', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Acquart', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Cognasse', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Forest', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gain', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Thuret', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}]",Transplantation,['10.1097/TP.0000000000003109']
3505,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3506,31868799,Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial.,"BACKGROUND


Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.
METHODS


This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.
DISCUSSION


The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.",2019,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"['major depressive disorder', 'Ninety-two drug-naive patients with MDD aged 18 to 65 years', 'adult patients with major depressive disorder (MDD']","['placebo', 'transcranial alternating current stimulation', 'Transcranial alternating current stimulation (tACS', '20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS']","['clinical global impression-improvement, the change in HDRS-17 score', 'remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score', 'rates of response at weeks 4 and 8 and rate of remission', 'efficacy and safety']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.347202,The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.,"[{'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Puren Hospital, Beijing 100062, China.'}, {'ForeName': 'Wen-Rui', 'Initials': 'WR', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhi-Chao', 'Initials': 'ZC', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Shu-Qin', 'Initials': 'SQ', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Bao-Quan', 'Initials': 'BQ', 'LastName': 'Min', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Chun-Qiu', 'Initials': 'CQ', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Ai-Hong', 'Initials': 'AH', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Qing', 'Initials': 'HQ', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Medical Research & Biometrics Centre, National Centre for Cardiovascular Diseases, Beijing 102300, China.'}, {'ForeName': 'Tian-Mei', 'Initials': 'TM', 'LastName': 'Si', 'Affiliation': 'Peking University Sixth Hospital, Beijing 100083, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Leng', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Wei-Jun', 'Initials': 'WJ', 'LastName': 'Ding', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Tian-Yi', 'Initials': 'TY', 'LastName': 'Yan', 'Affiliation': 'School of Life Science, Beijing Institute of Technology, Beijing 100081, China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000589']
3507,31775582,Effects of long-term psychodynamic psychotherapy on life quality in mentally disturbed children.,"Abstract   Objective:  Long-term psychodynamic psychotherapy for children aims not only at improving symptoms but also at changing the quality of life. To our knowledge, no studies exist to date that focused on both aspects. In this paper, we investigated changes in problem behavior and health-related quality of life based on long-term psychodynamic psychotherapy with children suffering from emotional and behavioral disorders.  Method:  We investigated 76 children in the treatment group and analyzed pre- and post-treatment symptoms. Furthermore, we compared the outcome data with a control group of 27 children of similar age and diagnoses who received no psychotherapy, both under routine care conditions. The children included in the study were treated on average for 66 sessions. Parent and adolescent ratings on the Achenbach Scales and the Quality of Life Inventory for Adolescents were compared before and after treatment.  Results:  We found a highly significant improvement of internalizing symptomatology based on parent ratings with a large effect. Different from prior investigations based on short-term psychodynamic psychotherapy we found changes in quality of life with large effects.  Conclusion:  These findings indicate that long-term psychodynamic treatment can improve life quality in children beyond symptom change.",2020,Parent and adolescent ratings on the Achenbach Scales and the Quality of Life Inventory for Adolescents were compared before and after treatment.  ,"['mentally disturbed children', 'children suffering from emotional and behavioral disorders', '76 children in the treatment group and analyzed pre- and post-treatment symptoms', '27 children of similar age and diagnoses who received no psychotherapy, both under routine care conditions']","['long-term psychodynamic psychotherapy', 'Long-term psychodynamic psychotherapy', 'psychodynamic psychotherapy']","['internalizing symptomatology', 'problem behavior and health-related quality of life', 'life quality', 'quality of life with large effects', 'Achenbach Scales and the Quality of Life Inventory for Adolescents']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0579055', 'cui_str': 'Long-term psychodynamic psychotherapy (regime/therapy)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}]","[{'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",76.0,0.0303833,Parent and adolescent ratings on the Achenbach Scales and the Quality of Life Inventory for Adolescents were compared before and after treatment.  ,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Krischer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Clinic of Cologne, Cologne, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Smolka', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Clinic of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Voigt', 'Affiliation': 'Cologne Bonn Academy for Psychotherapy (KBAP), Cologne, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Lehmkuhl', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Clinic of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans-Henning', 'Initials': 'HH', 'LastName': 'Flechtner', 'Affiliation': 'Hans-Henning Flechtner, Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic Medicine, University Clinic of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Franke', 'Affiliation': 'Institute of Developmental Science and Special Education, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University Clinic of Cologne, Cologne, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Trautmann-Voigt', 'Affiliation': 'Cologne Bonn Academy for Psychotherapy (KBAP), Cologne, Germany.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1695169']
3508,30945105,Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial.,"PURPOSE


About 55% of patients undergoing a Cesarean delivery under spinal or epidural anesthesia will experience shivering, which may interfere with the monitoring of vital signs. Recent studies have shown that dexmedetomidine could potentially help to alleviate shivering associated with anesthesia. We investigated whether dexmedetomidine, an alpha 2-adrenergic agonist, reduces the duration of shivering associated with neuraxial anesthesia during Cesarean delivery.
METHODS


Eighty parturients undergoing Cesarean delivery under neuraxial anesthesia and experiencing shivering were enlisted in this prospective, randomized, double-blind trial. After childbirth, the intervention group (n = 40) received a single intravenous bolus of dexmedetomidine (30 µg) while the control group (n = 40) received saline. Randomization and allocation were based on a computer-generated list. The primary outcome measure was the time required for an observable decrease in shivering after the intervention.
RESULTS


One hundred fifty-five patients were recruited, 80 of whom presented with shivering and were randomized. Our study showed that dexmedetomidine reduced the mean (standard deviation) duration of shivering after a single intravenous bolus to 2.6 (2.1) min after dexmedetomidine from 17.9 (12.6) min after saline (difference in means, -15.3 min; 95% confidence interval [CI], -11.2 to -19.4). The effect of dexmedetomidine persisted 15 min after the bolus was administered, as shivering had completely stopped in 90% of the patients in the intervention group vs 22.5% in the control group (relative risk, 4.0; 95% CI, 2.2 to 7.2). No adverse effects, including bradycardia, were observed.
CONCLUSION


A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02384343); registered 10 March, 2015.",2019,"A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
","['One hundred fifty-five patients were recruited, 80 of whom presented with shivering and were randomized', 'shivering during Cesarean delivery under neuraxial anesthesia', 'Eighty parturients undergoing Cesarean delivery under neuraxial anesthesia and experiencing shivering', 'patients undergoing a Cesarean delivery under spinal or epidural anesthesia']","['Intravenous dexmedetomidine', 'saline', 'dexmedetomidine']","['time required for an observable decrease in shivering', 'mean (standard deviation) duration of shivering', 'duration of shivering', 'adverse effects, including bradycardia', 'shivering']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}]",80.0,0.536914,"A single intravenous bolus of dexmedetomidine decreased the duration of shivering for up to 15 min during Cesarean delivery under neuraxial anesthesia.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lamontagne', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada. christina.lamontagne@umontreal.ca.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lesage', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Villeneuve', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Lidzborski', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Derstenfeld', 'Affiliation': 'Faculty of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Crochetière', 'Affiliation': 'CHU Sainte-Justine, 3175 Côte Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01354-3']
3509,31760958,Five salmon dinners per week were not sufficient to prevent the reduction in serum vitamin D in autumn at 60° north latitude: a randomised trial.,"Low serum concentrations of several vitamins have been linked to increased risk of diseases including insulin resistance and type 2 diabetes (T2D). Fish is a good source of several vitamins, and the prevalence of T2D is low in populations with high fish intake. The aim of the present study was to investigate the effects of high fish intake on vitamins in serum from adults in autumn in South-Western Norway at 60° north latitude. In this randomised clinical trial, sixty-three healthy participants with overweight/obesity consumed 750 g/week of either cod (n 22) or salmon (n 22) as five weekly dinners or were instructed to continue their normal eating habits but avoid fish intake (Control group, n 19) for 8 weeks. The estimated vitamin D intake was significantly increased in the Salmon group when compared with the Cod group (P = 6·3 × 10-4) and with the Control group (P = 3·5 × 10-6), with no differences between groups for estimated intake of vitamins A, B1, B2, B3, B6, B9, C and E. Serum 25-hydroxyvitamin D3 concentration was decreased in all groups after 8 weeks; however, the reduction in the Salmon group was significantly smaller compared with the Cod group (P = 0·013) and the Control group (P = 0·0060). Cod and salmon intake did not affect serum concentrations of the other measured vitamins. The findings suggest that 750 g/week of salmon was not sufficient to prevent a decrease in serum 25-hydroxyvitamin D3 in autumn in South-Western Norway in adults with overweight/obesity.",2020,"The estimated vitamin D intake was significantly increased in the Salmon group when compared to the Cod group (P=6.3x10-4) and to the Control group (P=3.5x10-6), while for vitamins A, B1, B2, B3, B6, B9, C and E, no differences in estimated intake were found between groups.","['adults with overweight/obesity in autumn in South-Western Norway at 60º north latitude', 'sixty-three healthy participants with overweight/obesity consumed 750 g/week of either cod (N=22) or salmon (N=22) as 5 weekly dinners, or', 'adults with overweight/obese']","['were instructed to continue their normal eating habits but avoid fish intake (Control group', 'cod or salmon']","['serum vitamin D', 'estimated vitamin D intake', 'Serum 25-hydroxyvitamin D3 concentration', 'serum concentrations', 'serum 25-hydroxyvitamin D3']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake (observable entity)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",63.0,0.0580852,"The estimated vitamin D intake was significantly increased in the Salmon group when compared to the Cod group (P=6.3x10-4) and to the Control group (P=3.5x10-6), while for vitamins A, B1, B2, B3, B6, B9, C and E, no differences in estimated intake were found between groups.","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bratlie', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Ingrid V', 'Initials': 'IV', 'LastName': 'Hagen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Helland', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Midttun', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Arve', 'Initials': 'A', 'LastName': 'Ulvik', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Grethe', 'Initials': 'G', 'LastName': 'Rosenlund', 'Affiliation': 'Skretting Aquaculture Research Centre AS, P.O. Box 48, 4001 Stavanger, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sveier', 'Affiliation': 'Lerøy Seafood Group ASA, P.O. Box 7600, 5020 Bergen, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Mellgren', 'Affiliation': 'Mohn Nutrition Research Laboratory, Department of Clinical Science, University of Bergen, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Per Magne', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Jonas Lies veg 87, 5021 Bergen, Norway.'}, {'ForeName': 'Oddrun A', 'Initials': 'OA', 'LastName': 'Gudbrandsen', 'Affiliation': 'Dietary Protein Research Group, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}]",The British journal of nutrition,['10.1017/S0007114519002964']
3510,30919909,Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial.,"AIMS


The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial.
METHODS AND RESULTS


By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis.
CONCLUSION


In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.",2019,"Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02].","['A total of 1858 patients', 'patients with and without PMI undergoing left main coronary artery intervention randomized to']","['PCI with everolimus-eluting stents vs. CABG', 'percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG', 'percutaneous coronary intervention and coronary artery bypass grafting']","['Periprocedural MI', 'cardiovascular death', '3-year mortality', '3-year rates of mortality', 'cardiovascular death and all-cause death', 'SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia', 'mortality', 'PCI and CABG [creatinine kinase-MB (CK-MB) elevation ']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",1858.0,0.284505,"Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02].","[{'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Heart at Mount Sinai Saint Luke's, New York, NY, USA.""}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'Department Cardiac Surgery, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Lembo', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'W Morris', 'Initials': 'WM', 'LastName': 'Brown', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, CA, USA.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College of Science, Technology and Medicine, London, UK.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehz113']
3511,31928505,A Study to Evaluate the Efficacy of Different Interventions for Improving Quality of Maternal Health Care Service in China.,"Abstract   Background/Introduction:   The quality of maternal health care service is a crucial determinant of maternal morbidities and mortalities. This study aimed to explore feasibility and relative efficacy of WeChat (WC), of specialist team (ST) service, and of combined of both interventions (WC-ST) for improving the quality of maternal health care in China.   Materials and Methods:   A four-arm randomized controlled trial of 1,400 pregnant women was conducted in three hospitals in Chengdu, Southwest China, from December 2016 to October 2017. Eligible women were randomly assigned to either of three intervention groups or the control group (service as usual; SAU). Main outcome measures were satisfaction rate and uptakes of maternal health care service at 49 days postpartum based on questionnaire survey.   Results:   No significant differences in satisfaction rate were found among four groups at baseline (p = 0.981), and significant group differences were noted at 49 days postpartum (p < 0.001), with the highest rate from WC-ST group (98.6%), followed by that of ST (95.2%) and WC (91.6%) groups, and SAU group being the lowest (85.2%). The same pattern of group difference was observed in measures of health care uptake behaviors. Most health care uptake measures from the baseline to post-trial were significantly improved within each of the intervention groups, while most such measures in the control group were not different from baseline to post-trial.   Discussion and Conclusions:   The WC and ST service is feasible and potentially effective in improving the quality of maternal health care service in China. The study has revealed limitations and options for improvement in future main trial.",2020,"Most health care uptake measures from the baseline to post-trial were significantly improved within each of the intervention groups, while most such measures in the control group were not different from baseline to post-trial.  ","['Maternal Health Care Service in China', 'maternal health care in China', '1,400 pregnant women was conducted in three hospitals in Chengdu, Southwest China, from December 2016 to October 2017', 'Eligible women']","['WeChat (WC), of specialist team (ST) service, and of combined of both interventions (WC-ST', 'control group (service as usual; SAU']","['health care uptake behaviors', 'satisfaction rate', 'satisfaction rate and uptakes of maternal health care service at 49 days postpartum based on questionnaire survey']","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",1400.0,0.0684802,"Most health care uptake measures from the baseline to post-trial were significantly improved within each of the intervention groups, while most such measures in the control group were not different from baseline to post-trial.  ","[{'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Sichuan Jinxin Women and Children's Hospital, Chengdu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Sichuan Jinxin Women and Children's Hospital, Chengdu, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'West China School of Public Health, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Chaojie', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Yunfen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Sichuan Jinxin Women and Children's Hospital, Chengdu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Chengdu Jinjiang Maternity and Child Health Hospital, Chengdu, China.'}, {'ForeName': 'Yongwu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Chengdu Jinjiang Maternity and Child Health Hospital, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Sichuan Jinxin Women and Children's Hospital, Chengdu, China.""}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': ""Sichuan Jinxin Women and Children's Hospital, Chengdu, China.""}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0230']
3512,31922425,Therapies after first-line afatinib in patients with  EGFR m +  NSCLC in Japan: retrospective analysis of LUX-Lung 3.,"Aim:  Acquired resistance to EGFR tyrosine kinase inhibitors is inevitable in non-small-cell lung cancer. To inform subsequent treatment decisions, we retrospectively assessed therapies following afatinib in Japanese patients from LUX-Lung 3.  Patients & methods:  LUX-Lung 3 was a randomized, open-label, Phase III study of afatinib versus cisplatin/pemetrexed in treatment-naive patients with  EGFR  mutation-positive ( EGFR m + ) advanced lung adenocarcinoma.  Results:  Among 47 Japanese patients who discontinued first-line afatinib, 91/81/62% received ≥one/two/three subsequent therapies. The most common second-line therapies were platinum-based chemotherapy (38%) and a first-generation EGFR tyrosine kinase inhibitor (17%). Median overall survival (afatinib vs cisplatin/pemetrexed) was 47.8 versus 35.0 months (not significant).  Conclusion:  First-line afatinib does not appear to diminish suitability for subsequent therapies in  EGFR m +  non-small-cell lung cancer.",2020,Median overall survival (afatinib vs cisplatin/pemetrexed) was 47.8 versus 35.0 months (not significant).  ,"['Japanese patients from LUX-Lung 3', 'patients with  EGFR m +  NSCLC in Japan', 'treatment-naive patients with  EGFR  mutation-positive ( EGFR m + ) advanced lung adenocarcinoma', '47 Japanese patients who discontinued first-line afatinib']","['EGFR tyrosine kinase inhibitors', 'cisplatin/pemetrexed', 'afatinib versus cisplatin/pemetrexed', 'platinum-based chemotherapy']",['Median overall survival'],"[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}]","[{'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",47.0,0.0282967,Median overall survival (afatinib vs cisplatin/pemetrexed) was 47.8 versus 35.0 months (not significant).  ,"[{'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata City 573-1191, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama 241-8515, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Kyushu University Hospital, Fukuoka 812-8582, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata 951-8566, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka 811-1395, Japan.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Kiura', 'Affiliation': 'Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama 700-8558, Japan.'}, {'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Health Informatics and Analytics, Boehringer Ingelheim (China) Investment Co., Shanghai 200040, China.'}, {'ForeName': 'Hisaya', 'Initials': 'H', 'LastName': 'Azuma', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim, Co., Ltd, Tokyo 141-6017, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama 641-8509, Japan.'}]","Future oncology (London, England)",['10.2217/fon-2019-0659']
3513,31964203,Contribution of diet to gut microbiota and related host cardiometabolic health: diet-gut interaction in human health.,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota. The human gut harbors diverse microbes that play an essential role in the well-being of their host. Complex interactions between diet and microorganisms may lead to beneficial or detrimental outcomes to host cardiometabolic health. Despite numerous studies using rodent models indicated that high-fat diet may disrupt protective functions of the intestinal barrier and contribute to inflammatory processes, evidence from population-based study is still limited. In our recent study of a 6-month randomized controlled-feeding trial, we showed that high-fat, low-carbohydrate diet was associated with unfavorable changes in gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors in healthy young adults. Here, we provide an overview and extended discussion of our key findings, and outline important future directions.",2020,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","['human health', 'healthy young adults']","['high-fat, low-carbohydrate diet']","['gut microbiota, fecal microbial metabolites, and plasma proinflammatory factors', 'Obesity and cardiometabolic diseases']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0199388,"Obesity and cardiometabolic diseases in both developed and developing counties in a state of nutrition transition are often related to diet, which also play a major role in shaping human gut microbiota.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Jiaomei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""No. 1 Department of Nutrition, Chinese People's Liberation Army General Hospital , Beijing, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University , Qingdao, China.'}]",Gut microbes,['10.1080/19490976.2019.1697149']
3514,31953834,"Effect of Different Musical Types on Patient's Relaxation, Anxiety and Pain Perception during Shock Wave Lithotripsy: A Randomized Controlled Study.","PURPOSE


The aim of this study was to investigate the effects of listening to different music types during extracorporeal shock wave lithotripsy (SWL) on the patients' pain control, anxiety level, and satisfaction.
MATERIALS AND METHODS


This study was a prospective single-blinded, paral-lel-group randomized clinical trial with balanced ran-domization [1:1]. A total of 150 patients who underwent first-session SWL were included in the study. The patients were randomly divided in to five groups (30 participants in each group) as follows: headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5. Demographic data related to patients and procedure, State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded immediately after the procedure.
RESULTS


There was a statistically significant difference between groups in terms of median VAS scores (7, 6, 4.5, 5, and 4, respectively, P<.001), whereas the VAS scores in Groups 3, 4, and 5 were significantly lower than those in Group 1 and 2 (P<.001). The median STAI-SA scores between the groups were significantly different (45, 45, 42, 45, and 40, respectively, P<.001), while the anxiety levels in Groups 3, 4, and 5 were significantly lower than those in Group 1 (P=.008, P=.018, and P<.001, respectively). Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
CONCLUSIONS


Music therapy during SWL reduced the patients' pain and anxiety scores, moreover listening to the patient's preferred music type provided greater satisfaction. Listening to the patient's preferred music type could be standardized and routinely used during SWL.",2020,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","['150 patients who underwent first-session SWL were included in the study', 'Shock Wave Lithotripsy']","['extracorporeal shock wave lithotripsy (SWL', 'headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5', 'Different Musical Types', 'Music therapy']","['median VAS scores', ""patients' pain and anxiety scores"", 'pain control, anxiety level, and satisfaction', 'anxiety levels', 'willingness to repeat the procedure and patient satisfaction rates', 'VAS scores', ""Patient's Relaxation, Anxiety and Pain Perception"", 'State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure ', 'median STAI-SA scores', 'patient satisfaction rates']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.0563542,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Çift', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey. dr.alicift@gmail.com.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Benlioglu', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.5333']
3515,31984473,Comparison of Urethral Dilation with Amplatz Dilators and Internal Urethrotomy Techniques for the Treatment of Urethral Strictures.,"PURPOSE


The most common option for the management of urethral stricture (US) is direct visual internal urethrotomy (DVIU), because it is an easy and minimally invasive technique but the low success and high recurrence rates of this technique make urologists research for different types of therapeutic alternatives in stricture treatment. In this study we aimed to compare the internal urethrotomy with amplatz dilation for the treatment of male US.
MATERIALS AND METHODS


A total of sixty patients, who have been operated due to urethral stricture were enrolled into this study. Group 1 was treated with amplatz renal dilators and the group 2 was treated with cold knife urethrotomy. All patients were evaluated for Qmax preoperatively and at the first, 3rd, 9th and 12th months postoperatively.
RESULTS


In the 3 month uroflowmetry results, mean Q max values were 15.6±2 ml/sec in amplatz group and 15.5±1.6 ml/sec in DVIU group. There was no statisticaly difference between the two groups. However the Q max values in the postoperative 9 and 12 months were significantly decreased in the DVIU group. In the DVIU group 9 recurrences (36%) appeared and 2 of these reccurrences were in the first 3 months, whereas in the amplatz group no recurrences appeared in the first 3 months. The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. Conclusions: In our experience, amplatz dilation is a good option as the initial treatment for urethral stricture.",2020,The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. ,"['male US', 'sixty patients, who have been operated due to urethral stricture', 'Urethral Strictures']","['Urethral Dilation with Amplatz Dilators and Internal Urethrotomy Techniques', 'amplatz renal dilators', 'internal urethrotomy with amplatz dilation', 'cold knife urethrotomy']","['urethral stricture recurrence rate', 'mean Q max values', 'Q max values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}]","[{'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0181467', 'cui_str': 'Knife, device (physical object)'}, {'cui': 'C0194550', 'cui_str': 'Incision of urethra (procedure)'}]","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.015268,The urethral stricture recurrence rate up to the 12 month follow up was statistically significant for group 1 when it is compared with group 2. ,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Karsli', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey. onurkarsli@yahoo.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ustuner', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}, {'ForeName': 'Omur', 'Initials': 'O', 'LastName': 'Memik', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Ulukaradag', 'Affiliation': 'University of Health Sciences, Derince Training and Research Hospital, Department of Urology, Kocaeli, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4662']